[{"id":"nct06856837","kind":"trial","name":"- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorec","aka":[],"tldr":"A phase 2 trial of fruquintinib, tislelizumab, trifluridine/tipiracil and bevacizumab (glioblastoma use) in colorectal cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, now recruiting.","summary":"- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases is a phase 2, randomised interventional study registered as NCT06856837 by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, with a registry enrolment figure of 140 participants, started 2025-10-27 and due to reach its primary completion in 2029-12-31. Interventions recorded: Fruquintinib; Tislelizumab; Trifluridine/tipiracil; Bevacizumab. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: To evaluate the efficacy of Fruquintinib in combination with the PD-1 inhibitor Tislelizumab in MSS/pMMR metastatic colorectal cancer without liver metastases.. Colorectal eligibility wording from the registry: \"Patient has been diagnosed with histologically or cytologically proven microsatellite stable (MSS)/proficient mismatch repair (pMMR) metastatic adenocarcinoma of the colon or rectum, which is not amenable to potentially curative resection\". Sites: Austria, Germany. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06856837","url":"https://clinicaltrials.gov/study/NCT06856837"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib","tislelizumab","trifluridine-tipiracil","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06856837","phase":"2","setting":"- IKF/AIO-QUINTIS - A Randomized Phase II Trial Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases","sponsor":"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest","started":"2025-10-27","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06829355","kind":"trial","name":"\"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer\"","aka":["THYMI"],"tldr":"A phase 2 trial of regorafenib and tislelizumab in colorectal cancer, run by Beijing Friendship Hospital, now recruiting.","summary":"\"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer\" is a phase 2, randomised interventional study registered as NCT06829355 by Beijing Friendship Hospital, with a registry enrolment figure of 52 participants, started 2025-02-11 and due to reach its primary completion in 2025-12-31. Interventions recorded: Thymalfasin (Thymosin alpha 1, Ta1); Regorafenib (BAY 73-4506); Tislelizumab (BGB-A317). Conditions listed: MCRC. Primary outcome: Progression-free survival (PFS). Colorectal eligibility wording from the registry: \"* Able to sign a written informed consent form (ICF) and able to understand and comply with the requirements of this study Male or female aged 18 to 75 Histologically or cytologically confirmed advanced or metastatic colorectal adenocarcinoma Mismatch repair (MMR) protein expression or microsatellit\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06829355","url":"https://clinicaltrials.gov/study/NCT06829355"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["regorafenib","tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06829355","phase":"2","setting":"Efficacy and Safety Study of Thymalfasin in Combination with Targeted Immunotherapy (Regorafenib and Tislelizumab) in Patients with Advanced PMMR/MSS Colorectal Cancer Who Failed Standard of Care: a Multicenter, Open-label, Randomized, Controlled Clinical Study","sponsor":"Beijing Friendship Hospital","started":"2025-02-11","startedType":"estimated","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04996875","kind":"trial","name":"(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis","aka":[],"tldr":"A phase 2 trial of Bezuclastinib in systemic mastocytosis, run by Cogent Biosciences, Inc., now recruiting.","summary":"(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis is a phase 2 interventional study registered as NCT04996875 by Cogent Biosciences, Inc., with 140 participants planned, started 2021-11-09 and due to reach its primary completion in 2025-09-19. Interventions recorded: bezuclastinib. Conditions listed: Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN), Mast Cell Leukemia (MCL), Aggressive Systemic Mastocytosis (ASM). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04996875","url":"https://clinicaltrials.gov/study/NCT04996875"}],"tags":["ctgov-ingest"],"related":[],"cancers":["systemic-mastocytosis","advanced-systemic-mastocytosis"],"sections":[],"technologies":[],"targets":[],"drugs":["bezuclastinib"],"companies":["cogent-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04996875","phase":"2","setting":"A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis","sponsor":"Cogent Biosciences, Inc.","started":"2021-11-09","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04910685","kind":"trial","name":"(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis","aka":["HARBOR"],"tldr":"A phase 2/3 trial testing Elenestinib in systemic mastocytosis, now recruiting.","summary":"(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis is a phase 2/3 interventional study registered as NCT04910685, led by Blueprint Medicines, and recruiting on the registry. Official title: A Randomised, Double-Blind, Placebo-Controlled Phase 2/3 Study of BLU-263 in Indolent Systemic Mastocytosis. Planned enrolment is 534 participants (estimated). The study started in 2021-11-30 and primary completion is expected in 2032-09-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04910685","url":"https://clinicaltrials.gov/study/NCT04910685"}],"tags":["ctgov-ingest"],"related":[],"cancers":["systemic-mastocytosis","indolent-systemic-mastocytosis"],"sections":[],"technologies":[],"targets":[],"drugs":["elenestinib"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04910685","phase":"2/3","setting":"A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study of BLU-263 in Indolent Systemic Mastocytosis","sponsor":"Blueprint Medicines","started":"2021-11-30","startedType":"actual","enrolled":534,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05907954","kind":"trial","name":"(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma","aka":[],"tldr":"A phase 2 trial of Darovasertib in melanoma and uveal melanoma, run by IDEAYA Biosciences, active and no longer recruiting.","summary":"(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma is a phase 2 interventional study registered as NCT05907954 by IDEAYA Biosciences, with 160 participants planned, started 2023-07-03 and due to reach its primary completion in 2027-04-30. Interventions recorded: Darovasertib. Conditions listed: Uveal Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05907954","url":"https://clinicaltrials.gov/study/NCT05907954"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","uveal-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["darovasertib"],"companies":["ideaya-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05907954","phase":"2","setting":"(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma","sponsor":"IDEAYA Biosciences","started":"2023-07-03","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05208047","kind":"trial","name":"(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors","aka":[],"tldr":"A phase 3 trial testing Bezuclastinib in gastrointestinal stromal tumour, now recruiting.","summary":"(Peak) A Phase 3 Randomised Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumours is a phase 3 interventional study registered as NCT05208047, led by Cogent Biosciences, and recruiting on the registry. Official title: A Phase 3 Randomised, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumours. Planned enrolment is 482 participants (estimated). The study started in 2022-04-14 and primary completion was reached in 2025-09-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05208047","url":"https://clinicaltrials.gov/study/NCT05208047"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gist"],"sections":[],"technologies":[],"targets":[],"drugs":["bezuclastinib"],"companies":["cogent-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registry status on 22 September 2026: Recruiting (registry record last updated 16 June 2026; primary completion reached 30 September 2025)."],"nct":"NCT05208047","phase":"3","setting":"A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors","sponsor":"Cogent Biosciences","started":"2022-04-14","startedType":"actual","enrolled":482,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03731260","kind":"trial","name":"(PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo ","aka":["PIONEER"],"tldr":"A phase 2 trial of Avapritinib in systemic mastocytosis, run by Blueprint Medicines Corporation, active and no longer recruiting.","summary":"(PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis is a phase 2 interventional study registered as NCT03731260 by Blueprint Medicines Corporation, with 251 participants enrolled, started 2019-04-16 and due to reach its primary completion in 2027-06-23. Interventions recorded: Avapritinib, Placebo. Conditions listed: Indolent Systemic Mastocytosis. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03731260","url":"https://clinicaltrials.gov/study/NCT03731260"}],"tags":["ctgov-ingest"],"related":[],"cancers":["systemic-mastocytosis","indolent-systemic-mastocytosis"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["avapritinib"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03731260","phase":"2","setting":"A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis With Symptoms Inadequately Controlled With Standard Therapy","sponsor":"Blueprint Medicines Corporation","started":"2019-04-16","startedType":"actual","enrolled":251,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05186753","kind":"trial","name":"(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis","aka":[],"tldr":"A phase 2 trial of Bezuclastinib in systemic mastocytosis, run by Cogent Biosciences, Inc., active and no longer recruiting.","summary":"(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis is a phase 2 interventional study registered as NCT05186753 by Cogent Biosciences, Inc., with 237 participants planned, started 2022-06-27 and due to reach its primary completion in 2025-05-22. Interventions recorded: Bezuclastinib Tablets (Formulation A), Bezuclastinib Tablets (Formulation B), Placebo Tablets. Conditions listed: SSM, Mastocytosis, Indolent, Mastocytosis, Systemic, Mastocytosis. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05186753","url":"https://clinicaltrials.gov/study/NCT05186753"}],"tags":["ctgov-ingest"],"related":[],"cancers":["systemic-mastocytosis","indolent-systemic-mastocytosis"],"sections":[],"technologies":[],"targets":[],"drugs":["bezuclastinib"],"companies":["cogent-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05186753","phase":"2","setting":"A Multi-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of The Safety and Efficacy of CGT9486 in Subjects With Nonadvanced Systemic Mastocytosis","sponsor":"Cogent Biosciences, Inc.","started":"2022-06-27","startedType":"actual","enrolled":237,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05607004","kind":"trial","name":"(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer","aka":["EVANGELINE"],"tldr":"A phase 2 trial of (Z)-endoxifen in HR-positive / HER2-negative breast cancer, run by Atossa Therapeutics, Inc., active and no longer recruiting.","summary":"(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer is a phase 2 interventional study registered as NCT05607004 by Atossa Therapeutics, Inc., with 87 participants enrolled, started 2023-02-14 and due to reach its primary completion in 2026-11. Interventions recorded: (Z)-endoxifen and goserelin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05607004","url":"https://clinicaltrials.gov/study/NCT05607004"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["atossa-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05607004","phase":"2","setting":"A Phase 2 Trial of (Z)-Endoxifen + Goserelin as Neoadjuvant Treatment for Premenopausal Women With ER+, HER2-, Breast Cancer","sponsor":"Atossa Therapeutics, Inc.","started":"2023-02-14","startedType":"actual","enrolled":87,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05936658","kind":"trial","name":"[18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Florastamin F-18 run by FutureChem, active.","summary":"[18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer is a phase 3 interventional study registered as NCT05936658 by FutureChem, with 138 participants enrolled, started 2023-05-08. Conditions listed: High Risk Prostate Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05936658","url":"https://clinicaltrials.gov/study/NCT05936658"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["florastamin-f18"],"companies":["futurechem"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05936658","phase":"3","setting":"A Multi-center, Open-label, Single Arm Phase III Clinical Trial for the Diagnostic Efficacy Assessment and Safety Evaluation by [18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer","sponsor":"FutureChem","started":"2023-05-08","startedType":"actual","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04252859","kind":"trial","name":"[18F]Fluoroestradiol-PET/CT Imaging of Invasive Lobular Carcinoma","aka":[],"tldr":"A phase 2 trial of FES PET in Breast cancer, run by University of Utah, recorded as terminated on the registry.","summary":"[18F]Fluoroestradiol-PET/CT Imaging of Invasive Lobular Carcinoma is a phase 2 interventional study registered as NCT04252859 by University of Utah, with 44 participants recorded, started 2020-12-11 and due to reach its primary completion in 2024-12-07. Interventions recorded: [18F]Fluoroestradiol (FES) PET/CT. Conditions recorded: Invasive Lobular Breast Carcinoma.\n\nLinked to the technology FES PET because the registry's title names it (\"18f fluoroestradiol pet\") and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04252859","url":"https://clinicaltrials.gov/study/NCT04252859"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["fes-pet"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04252859","phase":"2","setting":"[18F]Fluoroestradiol-Positron Emission Tomography (PET)/CT Imaging of Invasive Lobular Carcinoma","sponsor":"University of Utah","started":"2020-12-11","startedType":"actual","yearReported":2025,"enrolled":44,"enrolledBasis":"registry","outcomes":[{"endpoint":"Positive Detection Rate of Invasive Lobular Carcinoma (ILC)","primary":true,"unit":"lesions","arms":[{"name":"Pilot Phase","n":17,"value":22,"note":"Figures from the ClinicalTrials.gov results section (first posted 2025-05-18), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04252859?tab=results"},{"endpoint":"Relationship Between Presence of Heterogeneous FES-PET/CT Uptake at Baseline and Overall Survival","unit":"months","arms":[{"name":"Expansion Phase","n":3,"value":25.5,"note":"95% CI 21.67 to 46.82; Figures from the ClinicalTrials.gov results section (first posted 2025-05-18), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04252859?tab=results"}]},{"id":"nct07432633","kind":"trial","name":"[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications","aka":[],"tldr":"A phase 1/2 trial of [18F]FPyQCP in colorectal cancer, ovarian cancer, gastric & gastro-oesophageal junction cancer and pancreatic ductal adenocarcinoma, run by Blue Earth Diagnostics, now recruiting.","summary":"[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications is a phase 1/2 interventional study registered as NCT07432633 by Blue Earth Diagnostics, with 71 participants planned, started 2026-02-19 and due to reach its primary completion in 2028-01-31. Interventions recorded: [18F]FPyQCP.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07432633","url":"https://clinicaltrials.gov/study/NCT07432633"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","ovarian","gastric","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["blue-earth-diagnostics","medpace"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07432633","phase":"1/2","setting":"A Phase 1/2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications","sponsor":"Blue Earth Diagnostics","started":"2026-02-19","startedType":"actual","enrolled":71,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07702292","kind":"trial","name":"[68Ga]BED003 PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications","aka":[],"tldr":"A phase 2 trial of [68Ga]BED003 in colorectal cancer, ovarian cancer, gastric & gastro-oesophageal junction cancer and pancreatic ductal adenocarcinoma, run by Blue Earth Diagnostics, now recruiting.","summary":"[68Ga]BED003 PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications is a phase 2 interventional study registered as NCT07702292 by Blue Earth Diagnostics, with 71 participants planned, started 2026-06-30 and due to reach its primary completion in 2028-02. Interventions recorded: [68Ga]BED003.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07702292","url":"https://clinicaltrials.gov/study/NCT07702292"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","ovarian","gastric","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["blue-earth-diagnostics","medpace"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07702292","phase":"2","setting":"A Phase 2 Study of [68Ga]BED003 for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications","sponsor":"Blue Earth Diagnostics","started":"2026-06-30","startedType":"actual","enrolled":71,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05619016","kind":"trial","name":"[68Ga]Ga-ABY-025 PET for Quantification of HER2-status in Solid Tumors","aka":[],"tldr":"A phase 2 trial of HER2 PET in Breast cancer and HER2-positive gastric cancer, run by Karolinska University Hospital, with a status the registry has not verified recently.","summary":"[68Ga]Ga-ABY-025 PET for Quantification of HER2-status in Solid Tumors is a phase 2 interventional study registered as NCT05619016 by Karolinska University Hospital, with 72 participants planned, started 2022-11-23 and due to reach its primary completion in 2025-12-31. Interventions recorded: [68Ga]Ga-ABY-025 PET, Biopsy and analysis of HER2 expression. Conditions recorded: Esophageal Neoplasms, Gastric Neoplasms Malignant, Breast Cancer, HER2-positive Gastric Cancer.\n\nLinked to the technology HER2 PET because the registry names it (\"her2 pet\") among its interventions and Breast cancer and HER2-positive gastric cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05619016","url":"https://clinicaltrials.gov/study/NCT05619016"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer","gastric-her2-positive"],"sections":[],"technologies":["her2-pet"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05619016","phase":"2","setting":"Phase II Study of [68Ga]Ga-ABY-025 PET for Non-invasive Quantification of HER2-status in Solid Tumors","sponsor":"Karolinska University Hospital","started":"2022-11-23","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"tasquinimod-10tasq10","kind":"trial","name":"10TASQ10","aka":["10TASQ10","tasquinimod phase 3"],"tldr":"A drug aimed at the tissue around the tumour delayed progression on scans by two and a half months, and the men who took it lived, if anything, slightly less long.","summary":"10TASQ10 randomly assigned 1,245 men with chemotherapy-naive metastatic castration-resistant prostate cancer and bone metastases 2:1 to tasquinimod (832) or placebo (413). Median age was 71, 77.3 percent had a Karnofsky performance status of 90 percent or more and 21.1 percent had visceral metastases.\n\nEstimated median radiographic progression-free survival by central review was 7.0 months (95 percent confidence interval 5.8 to 8.2) with tasquinimod and 4.4 months (3.5 to 5.5) with placebo, hazard ratio 0.64 (0.54 to 0.75, p<0.001). Median overall survival was 21.3 months (19.5 to 23.0) with tasquinimod and 24.0 months (21.4 to 26.9) with placebo, hazard ratio 1.10 (0.94 to 1.28, p=0.25).\n\nGrade 3 or worse adverse events were more frequent with tasquinimod (42.8 against 33.6 percent), the commonest being anaemia, fatigue and cancer pain.\n\nTasquinimod and orteronel are the pair that should be quoted whenever radiographic progression-free survival is proposed as a registrational endpoint in prostate cancer. Both moved it a long way. Neither moved survival, and one moved it in the wrong direction.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01234311","url":"https://clinicaltrials.gov/study/NCT01234311"},{"label":"10TASQ10 (Journal of Clinical Oncology 2016)","url":"https://doi.org/10.1200/JCO.2016.66.9697"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["antiangiogenic"],"targets":[],"drugs":["tasquinimod"],"companies":["active-biotech","ipsen"],"institutions":[],"pathways":[],"terms":["castration-resistance","bone-metastases"],"trials":["elm-pc-4-orteronel"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01234311","phase":"3","setting":"Chemotherapy-naive metastatic castration-resistant prostate cancer with bone metastases: tasquinimod once daily against placebo, randomised 2:1, until progression or toxicity, with radiographic progression-free survival as the primary endpoint and overall survival as the key secondary endpoint","sponsor":"Active Biotech with Ipsen","result":"Median radiographic progression-free survival 7.0 against 4.4 months (hazard ratio 0.64, 95 percent confidence interval 0.54 to 0.75, p<0.001) but overall survival 21.3 against 24.0 months (1.10, 0.94 to 1.28, p=0.25).","started":"2011-03","yearReported":2016,"enrolled":1245,"enrolledBasis":"randomised","enrolledNote":"1,245 men were randomly assigned 2:1 between March 2011 and December 2012 at 241 sites in 37 countries.","outcomes":[{"endpoint":"Radiographic progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Tasquinimod","n":832,"value":7},{"name":"Placebo","n":413,"value":4.4}],"hr":0.64,"ci":[0.54,0.75],"p":"<0.001","source":"https://doi.org/10.1200/JCO.2016.66.9697"},{"endpoint":"Overall survival (median)","unit":"months","arms":[{"name":"Tasquinimod","n":832,"value":21.3},{"name":"Placebo","n":413,"value":24}],"hr":1.1,"ci":[0.94,1.28],"p":"0.25","source":"https://doi.org/10.1200/JCO.2016.66.9697"}],"replication":"ELM-PC 4 with orteronel produced the same dissociation in 1,560 men."},{"id":"nct07333651","kind":"trial","name":"125I Seed Implantation Plus Systemic Therapy for Oligoprogressive NSCLC or Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Li Min, not yet recruiting.","summary":"125I Seed Implantation Plus Systemic Therapy for Oligoprogressive NSCLC or Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07333651 by Li Min, with a registry enrolment figure of 90 participants, started 2026-01 and due to reach its primary completion in 2027-01-01. Interventions recorded: Standard-of-Care Systemic Therapy; 125I Seed Implantation. Conditions listed: Oligometastatic Disease. Primary outcome: Progression-Free Survival (PFS). Colorectal eligibility wording from the registry: \"* Histologically or cytologically confirmed metastatic non-small cell lung cancer (NSCLC) or colorectal cancer (CRC)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07333651","url":"https://clinicaltrials.gov/study/NCT07333651"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07333651","phase":"2","setting":"Standard-of-Care Systemic Therapy With or Without Image-Guided 125I Seed Implantation in Patients With Oligoprogressive Metastatic Non-Small Cell Lung Cancer or Colorectal Cancer: An Open-Label, Randomized, Controlled Phase 2 Study","sponsor":"Li Min","started":"2026-01","startedType":"estimated","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00450619","kind":"trial","name":"153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer","aka":[],"tldr":"A phase 2 trial of Samarium-153 lexidronam and Sargramostim in Prostate cancer, run by National Cancer Institute (NCI), completed.","summary":"153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer is a phase 2 interventional study registered as NCT00450619 by National Cancer Institute (NCI), with 44 participants recorded, started 2007-02 and reaching its primary completion in 2012-11. Interventions recorded: Samarium Sm 153 lexidronam pentasodium, Sargramostim, Recombinant vaccinia-TRICOM vaccine, Recombinant fowlpox-TRICOM vaccine. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Samarium-153 lexidronam because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00450619","url":"https://clinicaltrials.gov/study/NCT00450619"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["samarium-153-lexidronam","sargramostim"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00450619","phase":"2","setting":"A Randomized Phase 2.5 Study of (153)Sm-EDTMP (Quadramet) With or Without a PSA/TRICOM Vaccine in Men With Androgen-Insensitive Metastatic Prostate Cancer","sponsor":"National Cancer Institute (NCI)","started":"2007-02","yearReported":2013,"enrolled":44,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Arm A - EDTMP Alone","n":18,"value":1.7,"note":"95% CI 1.3 to 2.3; Figures from the ClinicalTrials.gov results section (first posted 2013-07-01), not from a publication"},{"name":"Arm B - 153Sm-EDTMP With Vaccine","n":21,"value":3.7,"note":"95% CI 2.4 to 4.7"}],"hr":0.5019,"p":"0.041","source":"https://clinicaltrials.gov/study/NCT00450619?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"Arm A - EDTMP Alone","n":18,"value":8.1,"note":"95% CI 3.5 to 13.3; Figures from the ClinicalTrials.gov results section (first posted 2013-07-01), not from a publication"},{"name":"Arm B - 153Sm-EDTMP With Vaccine","n":21,"value":9.2,"note":"95% CI 5.0 to 12.6"}],"hr":0.71,"ci":[0.37,1.35],"p":"0.30","source":"https://clinicaltrials.gov/study/NCT00450619?tab=results"}]},{"id":"nct07779694","kind":"trial","name":"16-Hour Fasting Plus Serplulimab and CAPEOX as Neoadjuvant Therapy in pMMR/MSS Advanced Mid-to-Low Rectal Cancer","aka":[],"tldr":"A phase 2 trial of serplulimab in colorectal cancer, run by Zhejiang University, not yet recruiting.","summary":"16-Hour Fasting Plus Serplulimab and CAPEOX as Neoadjuvant Therapy in pMMR/MSS Advanced Mid-to-Low Rectal Cancer is a phase 2, interventional study registered as NCT07779694 by Zhejiang University, with a registry enrolment figure of 51 participants, started 2026-10-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: 16-Hour Fasting; Serplulimab + chemotherapy. Conditions listed: pMMR/MSS; Locally Advanced Rectal Carcinoma; Fasting, Intermittent. Primary outcome: Pathological complete response rates. Colorectal eligibility wording from the registry: \"Histological or cytological documentation of adenocarcinoma of the rectum\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07779694","url":"https://clinicaltrials.gov/study/NCT07779694"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07779694","phase":"2","setting":"Neoadjuvant 16-Hour Fasting Combined With Serplulimab and CAPEOX for pMMR/MSS Locally Advanced Mid-to-Low Rectal Cancer: A Prospective, Single-Arm, Phase II Trial.","sponsor":"Zhejiang University","started":"2026-10-01","startedType":"estimated","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07189871","kind":"trial","name":"177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of 177Lu-BetaBart in prostate cancer, colorectal cancer, non-small-cell lung cancer, ovarian cancer, cervical cancer and endometrial cancer, run by Radiopharm Theranostics, Ltd, now recruiting.","summary":"177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT07189871 by Radiopharm Theranostics, Ltd, with 61 participants planned, started 2026-02-23 and due to reach its primary completion in 2027-12. Interventions recorded: 177Lu-BetaBart.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07189871","url":"https://clinicaltrials.gov/study/NCT07189871"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","colorectal","nsclc","ovarian","cervical","endometrial"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["medpace","radiopharm-theranostics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07189871","phase":"1/2","setting":"A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors","sponsor":"Radiopharm Theranostics, Ltd","started":"2026-02-23","startedType":"actual","enrolled":61,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06503146","kind":"trial","name":"18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection is a phase 2, interventional study registered as NCT06503146 by National Cancer Institute (NCI), with a registry enrolment figure of 320 participants, started 2025-09-09 and due to reach its primary completion in 2028-06-01. Interventions recorded: [18F]FAPI-74; [18F]FDG. Conditions listed: Sarcoma; Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer (EP-NEC); Mesothelioma; Pheochromocytoma/Paraganglioma (PPGL); Pancreatic Ductal Adenocarcinoma; Ovarian Cancer; Hepatocellular Carcinoma; Gastric Cancer; Cholangiocarcinoma; Bladder Cancer. Primary outcome: Mean number of lesions. Pancreatic eligibility wording from the registry: \"* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma/paraganglioma (PPGL), small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma \". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06503146","url":"https://clinicaltrials.gov/study/NCT06503146"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06503146","phase":"2","setting":"18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection","sponsor":"National Cancer Institute (NCI)","started":"2025-09-09","startedType":"actual","enrolled":320,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05479136","kind":"trial","name":"18F-Fluciclovine PET Imaging for Detecting High Grade Glioma Recurrence After Radiochemotherapy","aka":[],"tldr":"A phase 3 trial of Fluciclovine F-18 in Glioma & glioblastoma, run by Nicole Hill, with a status the registry has not verified recently.","summary":"18F-Fluciclovine PET Imaging for Detecting High Grade Glioma Recurrence After Radiochemotherapy is a phase 3 interventional study registered as NCT05479136 by Nicole Hill, with 30 participants planned, started 2022-08-24 and due to reach its primary completion in 2023-12-31. Interventions recorded: PET imaging with 18F fluciclovine. Conditions recorded: Grade III or Grade IV Glioma.\n\nLinked to the drug Fluciclovine F-18 because the registry names it among its interventions and Glioma & glioblastoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05479136","url":"https://clinicaltrials.gov/study/NCT05479136"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":["fluciclovine-f18"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05479136","phase":"3","setting":"18F-Fluciclovine PET Imaging for Detecting High Grade Glioma Recurrence After Radiochemotherapy","sponsor":"Nicole Hill","started":"2022-08-24","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04883814","kind":"trial","name":"18F-fluoroestradiol (FES) PET/CT for Breast Cancer","aka":[],"tldr":"A phase 2 trial of FES PET in Breast cancer, run by Hoag Memorial Hospital Presbyterian, with a status the registry has not verified recently.","summary":"18F-fluoroestradiol (FES) PET/CT for Breast Cancer is a phase 2 interventional study registered as NCT04883814 by Hoag Memorial Hospital Presbyterian, with 124 participants planned, started 2021-01-15 and due to reach its primary completion in 2023-12-15. Interventions recorded: 18F-fluoroestradiol PET/CT. Conditions recorded: Breast Cancer.\n\nLinked to the technology FES PET because the registry names it (\"18f fluoroestradiol pet\") among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04883814","url":"https://clinicaltrials.gov/study/NCT04883814"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["fes-pet"],"targets":[],"drugs":["fluoroestradiol-f18"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04883814","phase":"2","setting":"18F-fluoroestradiol (FES) PET/CT Compared To Standard-of-Care Imaging In Patients With Breast Cancer","sponsor":"Hoag Memorial Hospital Presbyterian","started":"2021-01-15","startedType":"actual","enrolled":124,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07043270","kind":"trial","name":"24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC","aka":[],"tldr":"A phase 2 trial of gemcitabine + nab-paclitaxel and fOLFIRINOX / mFOLFIRINOX in pancreatic cancer, run by Dartmouth-Hitchcock Medical Center, now recruiting.","summary":"24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC is a phase 2, interventional study registered as NCT07043270 by Dartmouth-Hitchcock Medical Center, with a registry enrolment figure of 35 participants, started 2025-09-29 and due to reach its primary completion in 2028-07-01. Interventions recorded: Nab-paclitaxel + Gemcitabine; modified FOLFIRINOX (mFOLFIRINOX). Conditions listed: Pancreas Adenocarcinoma. Primary outcome: One-year event-free survival (1y-EFS). Pancreatic eligibility wording from the registry: \"2024 Pancreatic Adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07043270","url":"https://clinicaltrials.gov/study/NCT07043270"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel","folfirinox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07043270","phase":"2","setting":"24BRO681 : Neoadjuvant Therapy With Alternating Gemcitabine Plus Nab-Paclitaxel and mFOLFIRINOX for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial","sponsor":"Dartmouth-Hitchcock Medical Center","started":"2025-09-29","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00943449","kind":"trial","name":"4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma","aka":[],"tldr":"A phase 2 trial of Resminostat and Sorafenib in Hepatocellular carcinoma, run by 4SC AG, completed.","summary":"4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma is a phase 2 interventional study registered as NCT00943449 by 4SC AG, with 57 participants recorded, started 2009-07 and reaching its primary completion in 2012-06. Interventions recorded: 4SC-201, Sorafenib. Conditions recorded: Hepatocellular Carcinoma.\n\nLinked to the drug Resminostat because the registry names it among its interventions and Hepatocellular carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00943449","url":"https://clinicaltrials.gov/study/NCT00943449"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":["resminostat","sorafenib"],"companies":["4sc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00943449","phase":"2","setting":"A Proof-of-concept Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of 4SC-201 and the Treatment Combination of Sorafenib Plus 4SC-201 in Patients With Hepatocellular Carcinoma Exhibiting Progressive Disease Under Sorafenib Treatment","sponsor":"4SC AG","started":"2009-07","enrolled":57,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07124884","kind":"trial","name":"5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet/Triplet Chemother","aka":["COLOSOTO"],"tldr":"A phase 2 trial in colorectal cancer, run by Federation Francophone de Cancerologie Digestive, not yet recruiting.","summary":"5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet/Triplet Chemotherapy With Advanced Unresectab is a phase 2, interventional study registered as NCT07124884 by Federation Francophone de Cancerologie Digestive, with a registry enrolment figure of 300 participants, started 2025-08-31 and due to reach its primary completion in 2030-06-30. Interventions recorded: Administration of experimental treatment association (sotorasib, panitumumab 5FU). Conditions listed: Colorectal Carcinoma; KRAS G12C Mutation; Unresectable Colorectal Cancer. Primary outcome: Percentage of patient alive or without progression 8 months after inclusion.. Colorectal eligibility wording from the registry: \"* Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma\". Sites: France, Germany, Italy, Spain. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07124884","url":"https://clinicaltrials.gov/study/NCT07124884"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","kras-g12c-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07124884","phase":"2","setting":"COLOSOTO: Single-arm Phase II Study Evaluating 5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet/Triplet Chemotherapy With Advanced Unresectab","sponsor":"Federation Francophone de Cancerologie Digestive","started":"2025-08-31","startedType":"estimated","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06887218","kind":"trial","name":"5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of regorafenib, fluorouracil (5-FU), leucovorin (folinic acid), bevacizumab (glioblastoma use) and other drugs in colorectal cancer, run by The Methodist Hospital Research Institute, now recruiting.","summary":"5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT06887218 by The Methodist Hospital Research Institute, with a registry enrolment figure of 57 participants, started 2025-05-08 and due to reach its primary completion in 2028-12. Interventions recorded: Regorafenib (BAY 73-4506); 5FU/LV; Bevacizumab; Trifluridine-tipiracil. Conditions listed: Metastatic Colorectal Cancer (CRC). Primary outcome: Efficacy of 5FU/LV in combination with regorafenib in metastatic colorectal cancer. Colorectal eligibility wording from the registry: \"Active or recent (within 3 years) non-colorectal cancer malignancies, except for low-risk, cured cancers (e\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06887218","url":"https://clinicaltrials.gov/study/NCT06887218"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["regorafenib","fluorouracil","leucovorin","bevacizumab-glioma","trifluridine-tipiracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06887218","phase":"2","setting":"Randomized Phase II Trial of 5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer","sponsor":"The Methodist Hospital Research Institute","started":"2025-05-08","startedType":"actual","enrolled":57,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04689347","kind":"trial","name":"5FU/LV, Irinotecan, Temozolomide and Bevacizumab for MGMT Silenced, Microsatellite Stable Metastatic Colorectal Cancer.","aka":["FLIRT"],"tldr":"A phase 1/2 trial of bevacizumab (glioblastoma use), fOLFIRI (5-FU, leucovorin, irinotecan), fOLFOX (5-FU, leucovorin, oxaliplatin) and temozolomide in colorectal cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, now recruiting.","summary":"5FU/LV, Irinotecan, Temozolomide and Bevacizumab for MGMT Silenced, Microsatellite Stable Metastatic Colorectal Cancer. is a phase 1/2, interventional study registered as NCT04689347 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, with a registry enrolment figure of 27 participants, started 2021-01-01 and due to reach its primary completion in 2026-04-30. Interventions recorded: Bevacizumab; Irinotecan; Leucovorin; 5Fluorouracil; Temozolomide. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: (Phase 1b) safety and to determine the recommended phase 2 dose of the combination of FLIRT- bevacizumab in patients with MGMT silenced and MSS mCRC, previously untreated for advanced disease. (Phase 2) efficacy of FLIRT/bev. Colorectal eligibility wording from the registry: \"Histologically confirmed metastatic adenocarcinoma of the colon and/or rectum\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04689347","url":"https://clinicaltrials.gov/study/NCT04689347"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["bevacizumab-glioma","folfiri","folfox","temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04689347","phase":"1/2","setting":"Phase 1b/2 Trial of 5-fluorouracil, Leucovorin, Irinotecan in Combination With Temozolomide (FLIRT) and Bevacizumab for the First-line Treatment of Patients With MGMT Silenced, Microsatellite Stable Metastatic Colorectal Cancer.","sponsor":"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","started":"2021-01-01","startedType":"actual","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06298916","kind":"trial","name":"64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer","aka":["PHANTOM"],"tldr":"A phase 1/2 trial of 64Cu-LNTH-1363S in sarcomas, oesophageal cancer, gastric & gastro-oesophageal junction cancer, pancreatic ductal adenocarcinoma and colorectal cancer, run by Lantheus Medical Imaging, now recruiting.","summary":"64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer is a phase 1/2 interventional study registered as NCT06298916 by Lantheus Medical Imaging, with 26 participants planned, started 2025-08 and due to reach its primary completion in 2025-11. Interventions recorded: 64Cu-LNTH-1363S.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06298916","url":"https://clinicaltrials.gov/study/NCT06298916"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma","esophageal","gastric","pancreatic","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["lantheus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06298916","phase":"1/2","setting":"A Phase 1/2a Study Utilizing 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET/CT Imaging Agent) in Patients With Sarcoma or Gastrointestinal Tract Cancer (PHANTOM Trial)","sponsor":"Lantheus Medical Imaging","started":"2025-08","startedType":"estimated","enrolled":26,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04868604","kind":"trial","name":"64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)","aka":["SECuRE"],"tldr":"A phase 1/2 trial of 64Cu-SAR-bisPSMA in prostate cancer, run by Clarity Pharmaceuticals Ltd, now recruiting.","summary":"64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE) is a phase 1/2 interventional study registered as NCT04868604 by Clarity Pharmaceuticals Ltd, with 54 participants planned, started 2021-08-11 and due to reach its primary completion in 2026-09. Interventions recorded: 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04868604","url":"https://clinicaltrials.gov/study/NCT04868604"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["clarity-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04868604","phase":"1/2","setting":"A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer","sponsor":"Clarity Pharmaceuticals Ltd","started":"2021-08-11","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06970847","kind":"trial","name":"64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer","aka":[],"tldr":"A phase 3 trial of 64Cu-SAR-bisPSMA in prostate cancer, run by Clarity Pharmaceuticals Ltd, active and no longer recruiting.","summary":"64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer is a phase 3 interventional study registered as NCT06970847 by Clarity Pharmaceuticals Ltd, with 220 participants enrolled, started 2025-05-16 and due to reach its primary completion in 2026-12-31. Interventions recorded: 64Cu-SAR-bisPSMA.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06970847","url":"https://clinicaltrials.gov/study/NCT06970847"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-bcr"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["clarity-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06970847","phase":"3","setting":"64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer","sponsor":"Clarity Pharmaceuticals Ltd","started":"2025-05-16","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04847505","kind":"trial","name":"68Ga-DOTA-TATE PET/CT Imaging in NETs","aka":[],"tldr":"A phase 3 trial of Gallium-68 DOTATATE in Neuroendocrine tumours, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke, with a status the registry has not verified recently.","summary":"68Ga-DOTA-TATE PET/CT Imaging in NETs is a phase 3 interventional study registered as NCT04847505 by Centre de recherche du Centre hospitalier universitaire de Sherbrooke, with 5000 participants planned, started 2020-01-01 and due to reach its primary completion in 2025-12-31. Interventions recorded: 68Ga-DOTA-TATE. Conditions recorded: Neuroendocrine Tumors.\n\nLinked to the drug Gallium-68 DOTATATE because the registry names it among its interventions and Neuroendocrine tumours among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04847505","url":"https://clinicaltrials.gov/study/NCT04847505"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine"],"sections":[],"technologies":[],"targets":[],"drugs":["ga68-dotatate"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04847505","phase":"3","setting":"Pragmatic Study on the Use of 68Ga-DOTA-TATE PET|CT Imaging as a Standard of Care to Influence Clinical Management","sponsor":"Centre de recherche du Centre hospitalier universitaire de Sherbrooke","started":"2020-01-01","startedType":"actual","enrolled":5000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06750419","kind":"trial","name":"89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study","aka":["ZIRCON-CP"],"tldr":"A phase 3 trial of Zirconium-89 girentuximab run by Telix Pharmaceuticals (Innovations) Pty Limited in renal cell carcinoma, now recruiting.","summary":"89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study is a phase 3 interventional study registered as NCT06750419 by Telix Pharmaceuticals (Innovations) Pty Limited, with 82 participants planned, started 2024-11-06. Conditions listed: Clear Cell Renal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06750419","url":"https://clinicaltrials.gov/study/NCT06750419"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc","clear-cell-rcc"],"sections":[],"technologies":["immuno-pet","caix-pet"],"targets":[],"drugs":["girentuximab-zr89"],"companies":["telix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06750419","phase":"3","setting":"A Confirmatory, Open-label, Single-arm, Multi-centre Study to Evaluate Safety, Tolerability and Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) to Non-invasively Detect Clear Cell Renal Cell Carcinoma (ccRCC) by Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Chinese Patients With Indeterminate Renal Masses (ZIRCON-CP Study)","sponsor":"Telix Pharmaceuticals (Innovations) Pty Limited","started":"2024-11-06","startedType":"actual","enrolled":82,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03849118","kind":"trial","name":"89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study","aka":[],"tldr":"A phase 3 trial of CAIX PET in Clear cell renal cell carcinoma, run by Telix Pharmaceuticals (Innovations) Pty Limited, completed.","summary":"89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study is a phase 3 interventional study registered as NCT03849118 by Telix Pharmaceuticals (Innovations) Pty Limited, with 300 participants recorded, started 2019-08-15 and reaching its primary completion in 2022-10-20. Interventions recorded: 89Zr-girentuximab. Conditions recorded: Clear Cell Renal Cell Carcinoma.\n\nLinked to the technology CAIX PET because the registry names it (\"89zr girentuximab\") among its interventions and Clear cell renal cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03849118","url":"https://clinicaltrials.gov/study/NCT03849118"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["clear-cell-rcc"],"sections":[],"technologies":["caix-pet"],"targets":[],"drugs":[],"companies":["telix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03849118","phase":"3","setting":"A Confirmatory, Prospective, Open-label, Multi-centre Phase 3 Study to Evaluate Diagnostic Performance of Zirconium-labelled Girentuximab to Non-invasively Detect ccRCC by PET/CT Imaging in Patients With Indeterminate Renal Masses","sponsor":"Telix Pharmaceuticals (Innovations) Pty Limited","started":"2019-08-15","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06823427","kind":"trial","name":"9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma","aka":[],"tldr":"A phase 2 trial of Toripalimab in bladder & urothelial cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd., now recruiting.","summary":"9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma is a phase 2 interventional study registered as NCT06823427 by Mabwell (Shanghai) Bioscience Co., Ltd., with 60 participants planned, started 2025-01-17 and due to reach its primary completion in 2026-06. Interventions recorded: 9MW2821 and Toripalimab (JS001 ).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06823427","url":"https://clinicaltrials.gov/study/NCT06823427"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":["mabwell-shanghai-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06823427","phase":"2","setting":"A Randomized Phase II Trial to Evaluate 9MW2821 in Combination With Toripalimab Compared With 9MW2821 Monotherapy for the 1st Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","started":"2025-01-17","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07314723","kind":"trial","name":"9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer","aka":[],"tldr":"A phase 2 trial of Toripalimab in bladder & urothelial cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd., now recruiting.","summary":"9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer is a phase 2 interventional study registered as NCT07314723 by Mabwell (Shanghai) Bioscience Co., Ltd., with 90 participants planned, started 2025-08-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: 9MW2821 and Toripalimab Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07314723","url":"https://clinicaltrials.gov/study/NCT07314723"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":["mabwell-shanghai-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07314723","phase":"2","setting":"A Single Arm, Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","started":"2025-08-01","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06079112","kind":"trial","name":"9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer","aka":[],"tldr":"A phase 1/2 trial of Toripalimab in bladder & urothelial cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd., now recruiting.","summary":"9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer is a phase 1/2 interventional study registered as NCT06079112 by Mabwell (Shanghai) Bioscience Co., Ltd., with 100 participants planned, started 2023-09-27 and due to reach its primary completion in 2026-12-31. Interventions recorded: 9MW2821 and Toripalimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06079112","url":"https://clinicaltrials.gov/study/NCT06079112"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":["mabwell-shanghai-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06079112","phase":"1/2","setting":"A Phase Ib/II, Open-label, Single Arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","started":"2023-09-27","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06592326","kind":"trial","name":"9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer","aka":[],"tldr":"A phase 3 trial of Toripalimab, Gemcitabine, Carboplatin and Cisplatin in bladder & urothelial cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd., now recruiting.","summary":"9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer is a phase 3 interventional study registered as NCT06592326 by Mabwell (Shanghai) Bioscience Co., Ltd., with 460 participants planned, started 2024-08-22 and due to reach its primary completion in 2027-09. Interventions recorded: 9MW2821, Toripalimab, Gemcitabine and Cisplatin/Carboplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06592326","url":"https://clinicaltrials.gov/study/NCT06592326"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab","gemcitabine","carboplatin","cisplatin"],"companies":["mabwell-shanghai-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06592326","phase":"3","setting":"A Randomized, Controlled, Open-label, Multicenter Phase 3 Clinical Study of 9MW2821 in Combination With Toripalimab Versus Standard Chemotherapy in First-line Locally Advanced or Metastatic Urothelial Cancer","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","started":"2024-08-22","startedType":"actual","enrolled":460,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04632108","kind":"trial","name":"A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ASKB589 Injection in advanced solid tumours, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT04632108 by Jiangsu Aosaikang Pharmaceutical Co., Ltd., with 199 participants enrolled, started 2021-01-28 and due to reach its primary completion in 2025-10-31. Interventions recorded: ASKB589 Injection.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04632108","url":"https://clinicaltrials.gov/study/NCT04632108"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["aosaikang-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04632108","phase":"1/2","setting":"A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors","sponsor":"Jiangsu Aosaikang Pharmaceutical Co., Ltd.","started":"2021-01-28","startedType":"actual","enrolled":199,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07563738","kind":"trial","name":"A 2-part Phase 1/2 Open-label Trial on ODM-212","aka":["TEADCO"],"tldr":"A phase 1/2 trial of Ipilimumab, Nivolumab, Gemcitabine in mesothelioma and non-small-cell lung cancer, run by Orion Corporation, Orion Pharma, now recruiting.","summary":"A 2-part Phase 1/2 Open-label Trial on ODM-212 is a phase 1/2 interventional study registered as NCT07563738 by Orion Corporation, Orion Pharma, with 229 participants planned, started 2026-03-27 and due to reach its primary completion in 2029-09. Interventions recorded: ODM-212, Ipilimumab and nivolumab, Gemcitabine and nab-paclitaxel, sotorasib. Conditions listed: Mesothelioma, Pancreatic Cancer, NSCLC (Advanced Non-small Cell Lung Cancer). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07563738","url":"https://clinicaltrials.gov/study/NCT07563738"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mesothelioma","nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ipilimumab","nivolumab","gemcitabine","paclitaxel","sotorasib"],"companies":["orion-orion-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07563738","phase":"1/2","setting":"A 2-part Phase 1/2 Open-label Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ODM-212 in Combination With Anti-cancer Therapy in Participants With Advanced Solid Tumours","sponsor":"Orion Corporation, Orion Pharma","started":"2026-03-27","startedType":"actual","enrolled":229,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05086692","kind":"trial","name":"A Beta-only IL-2 ImmunoTherapY Study","aka":["ABILITY-1"],"tldr":"A phase 1/2 trial of Pembrolizumab in renal cell carcinoma and non-small-cell lung cancer, run by Medicenna Therapeutics, Inc., now recruiting.","summary":"A Beta-only IL-2 ImmunoTherapY Study is a phase 1/2 interventional study registered as NCT05086692 by Medicenna Therapeutics, Inc., with 115 participants planned, started 2021-08-27 and due to reach its primary completion in 2026-06-30. Interventions recorded: MDNA11, Pembrolizumab (KEYTRUDA®). Conditions listed: Advanced Solid Tumor, Unresectable Solid Tumor, Clear Cell Renal Cell Carcinoma, Triple Negative Breast Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05086692","url":"https://clinicaltrials.gov/study/NCT05086692"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc","nsclc","sclc","colorectal","cervical"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05086692","phase":"1/2","setting":"A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors","sponsor":"Medicenna Therapeutics, Inc.","started":"2021-08-27","startedType":"actual","enrolled":115,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07332000","kind":"trial","name":"A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec","aka":[],"tldr":"A phase 2 trial of Aglatimagene besadenovec in prostate cancer, run by Candel Therapeutics, Inc., now recruiting.","summary":"A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec is a phase 2 interventional study registered as NCT07332000 by Candel Therapeutics, Inc., with 45 participants planned, started 2025-10-30 and due to reach its primary completion in 2027-02. Interventions recorded: aglatimagene besadenovec + valacyclovir, External Beam Radiation Therapy (EBRT). Conditions listed: Prostate Cancer Patients Treated by Radiotherapy, Prostate Cancer (Adenocarcinoma). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07332000","url":"https://clinicaltrials.gov/study/NCT07332000"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-intermediate-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["aglatimagene-besadenovec"],"companies":["candel-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07332000","phase":"2","setting":"A Biomarker Study in Men With Localized, Favorable, Intermediate-risk Prostate Cancer Treated With Aglatimagene Besadenovec","sponsor":"Candel Therapeutics, Inc.","started":"2025-10-30","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00923481","kind":"trial","name":"A Broad Multi-histology Phase II Study of the Multi-Kinase Inhibitor R935788 (Fostamatinib Disodium) in Advanced Colorectal, Non-small Cell Lung, Head and Neck Hepatocellular and Renal Cell Carcinomas, and Pheochromocytoma and Thyroid Tumors (Multi-H..","aka":[],"tldr":"A phase 2 trial of Fostamatinib in Head and neck squamous cell carcinoma and Pheochromocytoma and paraganglioma, run by National Cancer Institute (NCI), completed.","summary":"A Broad Multi-histology Phase II Study of the Multi-Kinase Inhibitor R935788 (Fostamatinib Disodium) in Advanced Colorectal, Non-small Cell Lung, Head and Neck Hepatocellular and Renal Cell Carcinomas, and Pheochromocytoma and Thyroid Tumors (Multi-H.. is a phase 2 interventional study registered as NCT00923481 by National Cancer Institute (NCI), with 37 participants recorded, started 2009-04 and reaching its primary completion in 2009-04. Interventions recorded: Fostamatinib disodium. Conditions recorded: Head and Neck Neoplasms, Pheochromocytoma, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell.\n\nLinked to the drug Fostamatinib because the registry names it among its interventions and Head and neck squamous cell carcinoma and Pheochromocytoma and paraganglioma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00923481","url":"https://clinicaltrials.gov/study/NCT00923481"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","pheochromocytoma-paraganglioma"],"sections":[],"technologies":[],"targets":[],"drugs":["fostamatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00923481","phase":"2","setting":"A Broad Multi-Histology Phase II Study of the Multi-Kinase Inhibitor R935788 (Fostamatinib Disodium) in Advanced Colorectal, Non-Small Cell Lung, Head and Neck, Hepatocellular and Renal Cell Carcinomas and Pheochromocytoma and Thyroid Tumors","sponsor":"National Cancer Institute (NCI)","started":"2009-04","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07078604","kind":"trial","name":"A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer","aka":["STEMVAC"],"tldr":"A phase 2 trial of sargramostim in triple-negative breast cancer, run by University of Washington, now recruiting.","summary":"A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer is a phase 2, interventional study registered as NCT07078604 by University of Washington, with a registry enrolment figure of 20 participants, started 2026-03-24 and due to reach its primary completion in 2027-04-30. Interventions recorded: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine; Chemotherapy; Computed Tomography; Sargramostim; Biospecimen Collection; Positron Emission Tomography (PET); Image Guided Biopsy. Conditions listed: Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Triple-Negative Breast Carcinoma. Triple-negative eligibility wording from the registry: \"* Histologically confirmed triple-negative breast cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07078604","url":"https://clinicaltrials.gov/study/NCT07078604"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["sargramostim"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07078604","phase":"2","setting":"A Phase II Trial of the Immunogenicity of a DNA Plasmid-Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDH3, CD105) in Patients With Metastatic Triple-Negative Breast Cancer","sponsor":"University of Washington","started":"2026-03-24","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04776330","kind":"trial","name":"a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease","aka":[],"tldr":"A phase 1/2 trial of BCMA targeted prime CAR-T cells in multiple myeloma, run by Chongqing Precision Biotech Co., Ltd, now recruiting.","summary":"a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease is a phase 1/2 interventional study registered as NCT04776330 by Chongqing Precision Biotech Co., Ltd, with 80 participants planned, started 2021-03-07 and due to reach its primary completion in 2026-12-31. Interventions recorded: BCMA targeted prime CAR-T cells.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04776330","url":"https://clinicaltrials.gov/study/NCT04776330"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["chongqing-precision-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04776330","phase":"1/2","setting":"Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease","sponsor":"Chongqing Precision Biotech Co., Ltd","started":"2021-03-07","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06508983","kind":"trial","name":"A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients","aka":[],"tldr":"A phase 3 trial testing SG301 in multiple myeloma, now recruiting.","summary":"A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients is a phase 3 interventional study registered as NCT06508983, led by Hangzhou Sumgen Biotech, and recruiting on the registry. Official title: A Phase 3 Randomised, Placebo-controlled, Double-blind, Multicenter Study Comparing SG301 in Combination With Pomalidomide and Dexamethasone Versus Placebo in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma. Planned enrolment is 360 participants (estimated). The study started in 2024-06-14 and primary completion is expected in 2027-03-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06508983","url":"https://clinicaltrials.gov/study/NCT06508983"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["sg301"],"companies":["hangzhou-sumgen-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06508983","phase":"3","setting":"A Phase 3 Randomized, Placebo-controlled, Double-blind, Multicenter Study Comparing SG301 in Combination With Pomalidomide and Dexamethasone Versus Placebo in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma","sponsor":"Hangzhou Sumgen Biotech","started":"2024-06-14","startedType":"actual","enrolled":360,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05335993","kind":"trial","name":"A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.","aka":[],"tldr":"A phase 2 trial of Oregovomab, Niraparib in ovarian cancer, run by CanariaBio Inc., active and no longer recruiting.","summary":"A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer. is a phase 2 interventional study registered as NCT05335993 by CanariaBio Inc., with 10 participants enrolled, started 2022-07-25 and due to reach its primary completion in 2026-12-30. Interventions recorded: Oregovomab, Niraparib. Conditions listed: Recurrent Ovarian Cancer, Recurrent Epithelial Cancer of Ovary, Recurrent Epithelial Ovarian Cancer, Recurrent Fallopian Tube Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05335993","url":"https://clinicaltrials.gov/study/NCT05335993"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["oregovomab","niraparib"],"companies":["canariabio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05335993","phase":"2","setting":"Phase 2, Single Arm Clinical Trial to Evaluate the Safety and Activity of Oregovomab and Niraparib as a Combinatorial Immune Priming Strategy in Subjects With Platinum Sensitive Recurrent Ovarian Cancer","sponsor":"CanariaBio Inc.","started":"2022-07-25","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07578337","kind":"trial","name":"A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for Advanced Disease.","aka":["NUMANTIA-2"],"tldr":"A phase 2 trial of gemcitabine, nab-paclitaxel and botensilimab in pancreatic cancer, run by Nelum Corp, not yet recruiting.","summary":"A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for Advanced Disease. is a phase 2, randomised interventional study registered as NCT07578337 by Nelum Corp, with a registry enrolment figure of 40 participants, started 2026-07-15 and due to reach its primary completion in 2029-02-28. Interventions recorded: Gemcitabine (1000 mg/m2); Nab-paclitaxel (Abraxane); NLM-001; Botensilimab; Balstililmab. Conditions listed: Untreated; Advanced Pancreatic Cancer. Primary outcome: To evaluate the response rate in each of the study arms, assessed according to iRECIST criteria, including the confirmation of progression to distinguish true progression from potential pseudoprogression.. Pancreatic eligibility wording from the registry: \"Histological or cytological diagnosis of pancreatic adenocarcinoma\". Sites: Spain. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07578337","url":"https://clinicaltrials.gov/study/NCT07578337"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","nab-paclitaxel","botensilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07578337","phase":"2","setting":"A Randomized Phase II Study of Priming Treatment With the Hedgehog Inhibitor NLM-001 Prior to Gemcitabine/Nab-Paclitaxel (GNab-P) plusBotensilimab and Balstilimab (Bot/Bal) Versus GNab-P in Patients With Previously Untreated Advanced Pancreatic Cancer (NUMANTIA-2)","sponsor":"Nelum Corp","started":"2026-07-15","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06341114","kind":"trial","name":"A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of BAT8008 injection in advanced solid tumours, run by Bio-Thera Solutions, active and no longer recruiting.","summary":"A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06341114 by Bio-Thera Solutions, with 112 participants enrolled, started 2024-04-12 and due to reach its primary completion in 2026-04-03. Interventions recorded: BAT8008 injection and BAT1308 injection.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06341114","url":"https://clinicaltrials.gov/study/NCT06341114"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bio-thera-solutions"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06341114","phase":"1/2","setting":"A Multicenter, Open-label Phase Ib-II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors","sponsor":"Bio-Thera Solutions","started":"2024-04-12","startedType":"actual","enrolled":112,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07414927","kind":"trial","name":"A Clinical Study for the Efficacy and Safety of BL0020 Injection in Patients With Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer Following E","aka":[],"tldr":"A phase 1/2 trial in lung cancer, run by Shanghai Best-Link Bioscience, LLC, not yet recruiting.","summary":"A Clinical Study for the Efficacy and Safety of BL0020 Injection in Patients With Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer Following EGFR TKI Therapy is a phase 1/2, interventional study registered as NCT07414927 by Shanghai Best-Link Bioscience, LLC, with a registry enrolment figure of 48 participants, started 2026-03-27 and due to reach its primary completion in 2027-12-22. Interventions recorded: BL0020. Conditions listed: Small Cell Carcinoma of Lung. Primary outcome: Objective response rate (ORR). Lung eligibility wording from the registry: \"Patients with initial diagnosis of EGFR-mutated NSCLC and histologically or cytologically confirmed transformation to SCLC following treatment with EGFR tyrosine kinase inhibitor\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07414927","url":"https://clinicaltrials.gov/study/NCT07414927"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07414927","phase":"1/2","setting":"An Open-Label, Single-Arm Phase I/II Clinical Study to Evaluate the Efficacy and Safety of BL0020 Injection in Patients With Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer Following EGFR TKI Therapy","sponsor":"Shanghai Best-Link Bioscience, LLC","started":"2026-03-27","startedType":"estimated","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06492005","kind":"trial","name":"A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of 9MW2821 in triple-negative breast cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd., now recruiting.","summary":"A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer is a phase 2 interventional study registered as NCT06492005 by Mabwell (Shanghai) Bioscience Co., Ltd., with 160 participants planned, started 2024-07-26 and due to reach its primary completion in 2026-07. Interventions recorded: 9MW2821 and PD-1 inhibitior.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06492005","url":"https://clinicaltrials.gov/study/NCT06492005"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":["pd1"],"drugs":[],"companies":["mabwell-shanghai-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06492005","phase":"2","setting":"A Phase II Clinical Study of Efficacy and Safety of 9MW2821Monotherapy or Combined With PD-1 Inhibitor in Locally Advanced or Metastatic Triple-Negative Breast Cancer","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","started":"2024-07-26","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07454720","kind":"trial","name":"A Clinical Study of Adebrelimab in Combination With SHR-8068 and Chemoradiotherapy as Perioperative Therapy for Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2/3 trial of SHR-8068 in colorectal cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Clinical Study of Adebrelimab in Combination With SHR-8068 and Chemoradiotherapy as Perioperative Therapy for Locally Advanced Rectal Cancer is a phase 2/3 interventional study registered as NCT07454720 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 165 participants planned, started 2026-03-23 and due to reach its primary completion in 2032-11. Interventions recorded: Adebrelimab in combination with SHR-8068 and chemotherapy, Adebrelimab combined with chemotherapy, Chemotherapy. Conditions listed: Locally Advanced Resectable Rectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07454720","url":"https://clinicaltrials.gov/study/NCT07454720"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-8068"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07454720","phase":"2/3","setting":"A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study of Adebrelimab Combined With SHR-8068 and Chemoradiotherapy as Perioperative Therapy for Locally Advanced Resectable Rectal Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2026-03-23","startedType":"actual","enrolled":165,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06922383","kind":"trial","name":"A Clinical Study of Arfolitixorin in Patients With mCRC","aka":[],"tldr":"A phase 1/2 trial of Arfolitixorin in colorectal cancer, run by Isofol Medical AB, now recruiting.","summary":"A Clinical Study of Arfolitixorin in Patients With mCRC is a phase 1/2 interventional study registered as NCT06922383 by Isofol Medical AB, with 90 participants planned, started 2025-04-10 and due to reach its primary completion in 2028-11-30. Interventions recorded: Arfolitixorin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06922383","url":"https://clinicaltrials.gov/study/NCT06922383"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06922383","phase":"1/2","setting":"A Phase 1b/2 Study of Arfolitixorin as Part of 5-fluorouracil-based Treatment Regimens in the First-line Treatment of Metastatic Colorectal Cancer","sponsor":"Isofol Medical AB","started":"2025-04-10","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05732805","kind":"trial","name":"A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma","aka":["OCTAVA"],"tldr":"A phase 3 trial testing BCD-217 in melanoma, active and no longer recruiting.","summary":"A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma is a phase 3 interventional study registered as NCT05732805, led by Biocad, and active but no longer recruiting on the registry. Official title: A Double-Blind Placebo-Controlled Comparative Randomised Clinical Study of the Efficacy and Safety of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma. Planned enrolment is 270 participants (estimated). The study started in 2022-08-02 and primary completion is expected in 2024-06-20. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05732805","url":"https://clinicaltrials.gov/study/NCT05732805"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["bcd-217","bcd-100"],"companies":["biocad"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05732805-eur-j-cancer-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05732805","phase":"3","setting":"A Double-Blind Placebo-Controlled Comparative Randomized Clinical Study of the Efficacy and Safety of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma","sponsor":"Biocad","started":"2022-08-02","startedType":"actual","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07489495","kind":"trial","name":"A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)","aka":["LITESPARK-034"],"tldr":"A phase 3 trial testing Zanzalintinib in renal cell carcinoma, now recruiting.","summary":"A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034) is a phase 3 interventional study registered as NCT07489495, led by Merck Sharp & Dohme with Exelixis, and recruiting on the registry. Official title: A Phase 3, Randomised, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants With Advanced RCC Who Have Progressed on or After Both PD-1/L1 and VEGF-TKI Therapies in Sequence or in Combination (LITESPARK-034). Planned enrolment is 758 participants (estimated). The study started in 2026-04-09 and primary completion is expected in 2030-11-27. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07489495","url":"https://clinicaltrials.gov/study/NCT07489495"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["zanzalintinib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07489495","phase":"3","setting":"A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants With Advanced RCC Who Have Progressed on or After Both PD-1/L1 and VEGF-TKI Therapies in Sequence or in Combination (LITESPARK-034)","sponsor":"Merck Sharp & Dohme","started":"2026-04-09","startedType":"actual","enrolled":758,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07227402","kind":"trial","name":"A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)","aka":["LITESPARK-033"],"tldr":"A phase 3 trial testing Zanzalintinib in renal cell carcinoma, now recruiting.","summary":"A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033) is a phase 3 interventional study registered as NCT07227402, led by Merck Sharp & Dohme with Exelixis, and recruiting on the registry. Official title: A Phase 3, Randomised, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants With Advanced RCC Who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033). Planned enrolment is 904 participants (estimated). The study started in 2025-11-26 and primary completion is expected in 2032-02-27. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07227402","url":"https://clinicaltrials.gov/study/NCT07227402"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["zanzalintinib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07227402","phase":"3","setting":"A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants With Advanced RCC Who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)","sponsor":"Merck Sharp & Dohme","started":"2025-11-26","startedType":"actual","enrolled":904,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07190248","kind":"trial","name":"A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)","aka":["KANDLELIT-007"],"tldr":"A phase 3 trial testing Calderasib in non-small-cell lung cancer, now recruiting.","summary":"A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007) is a phase 3 interventional study registered as NCT07190248, led by Merck Sharp & Dohme, and recruiting on the registry. Official title: A Phase 3, Randomised, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007). Planned enrolment is 675 participants (estimated). The study started in 2025-10-08 and primary completion is expected in 2029-12-07. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07190248","url":"https://clinicaltrials.gov/study/NCT07190248"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["calderasib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07190248","phase":"3","setting":"A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)","sponsor":"Merck Sharp & Dohme","started":"2025-10-08","startedType":"actual","enrolled":675,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07209111","kind":"trial","name":"A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)","aka":["KANDLELIT-014"],"tldr":"A phase 2 trial of Calderasib and Cetuximab in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014) is a phase 2 interventional study registered as NCT07209111 by Merck Sharp & Dohme LLC, with 150 participants planned, started 2025-12-04 and due to reach its primary completion in 2032-04-09. Interventions recorded: Calderasib and Cetuximab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07209111","url":"https://clinicaltrials.gov/study/NCT07209111"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["calderasib","cetuximab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07209111","phase":"2","setting":"A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination With Cetuximab, in Participants With KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-12-04","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06997497","kind":"trial","name":"A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)","aka":["KANDLELIT-012"],"tldr":"A phase 3 trial testing Calderasib in colorectal cancer, now recruiting.","summary":"A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) is a phase 3 interventional study registered as NCT06997497, led by Merck Sharp & Dohme, and recruiting on the registry. Official title: A Phase 3, Randomised, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 Versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012). Planned enrolment is 477 participants (estimated). The study started in 2025-07-16 and primary completion is expected in 2029-03-28. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06997497","url":"https://clinicaltrials.gov/study/NCT06997497"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","kras-g12c-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["calderasib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06997497","phase":"3","setting":"A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 Versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)","sponsor":"Merck Sharp & Dohme","started":"2025-07-16","startedType":"actual","enrolled":477,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06296706","kind":"trial","name":"A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer","aka":[],"tldr":"A phase 3 trial of Docetaxel in gastric & gastro-oesophageal junction cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., now recruiting.","summary":"A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer is a phase 3 interventional study registered as NCT06296706 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., with 630 participants planned, started 2024-02-27 and due to reach its primary completion in 2026-06-01. Interventions recorded: Docetaxel for injection (Albumin-bound) and Taxotere (docetaxel).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06296706","url":"https://clinicaltrials.gov/study/NCT06296706"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06296706","phase":"3","setting":"A Multicenter, Randomized, Controlled Phase III Clinical Study of Docetaxel for Injection (Albumin-bound) Versus Taxotere in Gastric Cancer","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","started":"2024-02-27","startedType":"actual","enrolled":630,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07227597","kind":"trial","name":"A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)","aka":[],"tldr":"A phase 1/2 trial of Ifinatamab deruxtecan, Atezolizumab, Carboplatin in small-cell lung cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003) is a phase 1/2 interventional study registered as NCT07227597 by Merck Sharp & Dohme LLC, with 170 participants planned, started 2026-01-29 and due to reach its primary completion in 2030-11-29. Interventions recorded: Gocatamig, I-DXd, Atezolizumab, Carboplatin, Etoposide. Conditions listed: Small Cell Lung Cancer Extensive Stage. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07227597","url":"https://clinicaltrials.gov/study/NCT07227597"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["ifinatamab-deruxtecan","atezolizumab","carboplatin","etoposide"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07227597","phase":"1/2","setting":"A Phase 1b/2 Open-label Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line Extensive Stage Small Cell Lung Cancer","sponsor":"Merck Sharp & Dohme LLC","started":"2026-01-29","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06974929","kind":"trial","name":"A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of HRS-6209 Capsules in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer is a phase 1/2 interventional study registered as NCT06974929 by Jiangsu HengRui Medicine Co., Ltd., with 80 participants planned, started 2025-05-22 and due to reach its primary completion in 2026-12. Interventions recorded: HRS-6209 Capsules, Letrozole Tablets and HRS-2189 Tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06974929","url":"https://clinicaltrials.gov/study/NCT06974929"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06974929","phase":"1/2","setting":"An Open-Label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 Combination Therapy in Patients With Breast Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-05-22","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07446153","kind":"trial","name":"A Clinical Study of HRS-8364 in the Treatment of Advanced Solid Tumor Subjects","aka":[],"tldr":"A phase 1/2 trial of HRS-8364 Tablet in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Clinical Study of HRS-8364 in the Treatment of Advanced Solid Tumor Subjects is a phase 1/2 interventional study registered as NCT07446153 by Jiangsu HengRui Medicine Co., Ltd., with 282 participants planned, started 2026-03-19 and due to reach its primary completion in 2028-12. Interventions recorded: HRS-8364 Tablet.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07446153","url":"https://clinicaltrials.gov/study/NCT07446153"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07446153","phase":"1/2","setting":"An Open Label, Multicenter Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-8364 in the Treatment of Advanced Solid Tumor Subjects","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2026-03-19","startedType":"actual","enrolled":282,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05923008","kind":"trial","name":"A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of IBI130 in advanced solid tumours, run by Innovent Biologics (Suzhou) Co. Ltd., now recruiting.","summary":"A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05923008 by Innovent Biologics (Suzhou) Co. Ltd., with 182 participants planned, started 2023-11-14 and due to reach its primary completion in 2024-11-30. Interventions recorded: IBI130.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05923008","url":"https://clinicaltrials.gov/study/NCT05923008"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05923008","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open-label Study of IBI130 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","started":"2023-11-14","startedType":"actual","enrolled":182,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06925737","kind":"trial","name":"A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","aka":["IDeate-Prostate01"],"tldr":"A phase 3 trial of Ifinatamab deruxtecan, Docetaxel, Prednisone in prostate cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) is a phase 3 interventional study registered as NCT06925737 by Merck Sharp & Dohme LLC, with 1440 participants planned, started 2025-05-13 and due to reach its primary completion in 2028-06-26. Interventions recorded: Ifinatamab deruxtecan, Docetaxel, Prednisone, Rescue Medication. Conditions listed: Prostate Cancer, Prostatic Neoplasms. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06925737","url":"https://clinicaltrials.gov/study/NCT06925737"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy"],"targets":[],"drugs":["ifinatamab-deruxtecan","docetaxel","prednisone"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06925737","phase":"3","setting":"A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-05-13","startedType":"actual","enrolled":1440,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06863272","kind":"trial","name":"A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)","aka":["IDeate-Prostate02"],"tldr":"A phase 1/2 trial of Docetaxel, Ifinatamab deruxtecan, Opevesostat and Enzalutamide in prostate cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02) is a phase 1/2 interventional study registered as NCT06863272 by Merck Sharp & Dohme LLC, with 360 participants planned, started 2025-07-03 and due to reach its primary completion in 2031-04-01. Interventions recorded: Docetaxel, Ifinatamab Deruxtecan, Opevesostat, Abiraterone, Enzalutamide and Rescue Medication.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06863272","url":"https://clinicaltrials.gov/study/NCT06863272"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["docetaxel","ifinatamab-deruxtecan","opevesostat","enzalutamide"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06863272","phase":"1/2","setting":"MK-2400-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-07-03","startedType":"actual","enrolled":360,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06833073","kind":"trial","name":"A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)","aka":["INTerpath-011"],"tldr":"A phase 2 trial of Intismeran autogene in bladder & urothelial cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011) is a phase 2 interventional study registered as NCT06833073 by Merck Sharp & Dohme LLC, with 308 participants planned, started 2025-03-11 and due to reach its primary completion in 2031-09-03. Interventions recorded: Intismeran autogene and BCG.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06833073","url":"https://clinicaltrials.gov/study/NCT06833073"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["neoantigen-mrna-vaccine"],"targets":[],"drugs":["intismeran-autogene"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06833073","phase":"2","setting":"A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-03-11","startedType":"actual","enrolled":308,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06961006","kind":"trial","name":"A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)","aka":["INTerpath-012"],"tldr":"A phase 2 trial of Intismeran autogene, Pembrolizumab in melanoma, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012) is a phase 2 interventional study registered as NCT06961006 by Merck Sharp & Dohme LLC, with 160 participants planned, started 2025-05-29 and due to reach its primary completion in 2028-07-22. Interventions recorded: Intismeran autogene, Pembrolizumab, Placebo. Conditions listed: Malignant Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06961006","url":"https://clinicaltrials.gov/study/NCT06961006"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor","neoantigen-mrna-vaccine"],"targets":[],"drugs":["intismeran-autogene","pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06961006","phase":"2","setting":"A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants With First-Line Advanced Melanoma (INTerpath-012)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-05-29","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06305767","kind":"trial","name":"A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)","aka":["INTerpath-005"],"tldr":"A phase 1/2 trial of Pembrolizumab, Intismeran autogene and Enfortumab vedotin in bladder & urothelial cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005) is a phase 1/2 interventional study registered as NCT06305767 by Merck Sharp & Dohme LLC, with 230 participants enrolled, started 2024-03-28 and due to reach its primary completion in 2027-04-23. Interventions recorded: Pembrolizumab, Intismeran autogene, Enfortumab Vedotin and Surgery (RC plus PLND).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06305767","url":"https://clinicaltrials.gov/study/NCT06305767"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor","neoantigen-mrna-vaccine"],"targets":[],"drugs":["pembrolizumab","intismeran-autogene","enfortumab-vedotin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06305767","phase":"1/2","setting":"A Phase 1/2 Study of V940 Plus Pembrolizumab With or Without Enfortumab Vedotin in Muscle-Invasive Urothelial Carcinoma (MIUC) (INTerpath-005)","sponsor":"Merck Sharp & Dohme LLC","started":"2024-03-28","startedType":"actual","enrolled":230,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04370587","kind":"trial","name":"A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Adva","aka":[],"tldr":"A phase 1/2 trial of T3011, Pembrolizumab in melanoma, run by ImmVira Pharma Co. Ltd, now recruiting.","summary":"A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT04370587 by ImmVira Pharma Co. Ltd, with 30 participants planned, started 2020-09-17 and due to reach its primary completion in 2026-09-22. Interventions recorded: T3011, T3011 + pembrolizumab. Conditions listed: Solid Tumor, Melanoma, HNSCC, Sarcoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04370587","url":"https://clinicaltrials.gov/study/NCT04370587"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["t3011","pembrolizumab"],"companies":["immvira-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04370587","phase":"1/2","setting":"A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors","sponsor":"ImmVira Pharma Co. Ltd","started":"2020-09-17","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07446387","kind":"trial","name":"A Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX/mCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of Iparomlimab and tuvonralimab in Colorectal cancer, run by Jiangsu Cancer Institute & Hospital, not yet recruiting.","summary":"A Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX/mCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer is a phase 2 interventional study registered as NCT07446387 by Jiangsu Cancer Institute & Hospital, with 70 participants planned, started 2026-05-30 and due to reach its primary completion in 2028-12-31. Interventions recorded: Iparomlimab and tuvonralimab. Conditions recorded: Metastatic Colorectal Cancer (CRC).\n\nLinked to the drug Iparomlimab and tuvonralimab because the registry names it among its interventions and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07446387","url":"https://clinicaltrials.gov/study/NCT07446387"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["iparomlimab-tuvonralimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07446387","phase":"2","setting":"A Prospective, Single-arm, Multicenter Phase II Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX/mCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer","sponsor":"Jiangsu Cancer Institute & Hospital","started":"2026-05-30","startedType":"estimated","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07502014","kind":"trial","name":"A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line","aka":[],"tldr":"A phase 2 trial of iparomlimab and tuvonralimab and fruquintinib in colorectal cancer, run by Huazhong University of Science and Technology, not yet recruiting.","summary":"A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07502014 by Huazhong University of Science and Technology, with a registry enrolment figure of 60 participants, started 2026-05-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: Iparomlimab and Tuvonralimab (QL1706); Fruquintinib; Heterogeneous Radiotherapy. Conditions listed: Metastatic Colorectal Cancer (CRC); mCRC. Primary outcome: Progression-Free Survival. Colorectal eligibility wording from the registry: \"* Histologically or cytologically confirmed stage Ⅳ primary colorectal cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07502014","url":"https://clinicaltrials.gov/study/NCT07502014"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","imrt-igrt","kinase-inhibitors"],"targets":[],"drugs":["iparomlimab-tuvonralimab","fruquintinib"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07502014","phase":"2","setting":"A Randomized, Parallel, Open-Label, Multicenter Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer","sponsor":"Huazhong University of Science and Technology","started":"2026-05-01","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06735391","kind":"trial","name":"A Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Sensitive Mutations","aka":[],"tldr":"A phase 3 trial testing JMT101 in non-small-cell lung cancer, now recruiting.","summary":"A Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Sensitive Mutations is a phase 3 interventional study registered as NCT06735391, led by Shanghai JMT-Bio, and recruiting on the registry. Official title: A Phase 3 Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Sensitive Mutations. Planned enrolment is 516 participants (estimated). The study started in 2024-10-23 and primary completion is expected in 2026-09-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06735391","url":"https://clinicaltrials.gov/study/NCT06735391"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["jmt101"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06735391","phase":"3","setting":"A Phase 3 Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Sensitive Mutations","sponsor":"Shanghai JMT-Bio","started":"2024-10-23","startedType":"actual","enrolled":516,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06208410","kind":"trial","name":"A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of JS105, Fulvestrant, Dalpiciclib, Toripalimab, Pyrotinib and Capecitabine in advanced solid tumours, run by Risen (Suzhou) Pharma Tech Co., Ltd., now recruiting.","summary":"A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors is a phase 1/2 interventional study registered as NCT06208410 by Risen (Suzhou) Pharma Tech Co., Ltd., with 306 participants planned, started 2024-01-11 and due to reach its primary completion in 2027-02-26. Interventions recorded: JS105, Fulvestrant injection, Dalpiciclib Isetionate Tablets, Toripalimab Injection, Paclitaxel for Injection (Albumin Bound) and Fluzoparib Capsules.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06208410","url":"https://clinicaltrials.gov/study/NCT06208410"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["js105","fulvestrant","dalpiciclib","toripalimab","pyrotinib","capecitabine","fluzoparib"],"companies":["junshi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06208410","phase":"1/2","setting":"A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors","sponsor":"Risen (Suzhou) Pharma Tech Co., Ltd.","started":"2024-01-11","startedType":"actual","enrolled":306,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07585279","kind":"trial","name":"A Clinical Study of Liposomal Irinotecan for Second-Line Therapy in Metastatic Colorectal Cancer","aka":["IRIS-02"],"tldr":"A phase 2/3 trial of irinotecan (and liposomal irinotecan), fluorouracil (5-FU), leucovorin (folinic acid), bevacizumab (glioblastoma use) and other drugs in colorectal cancer, run by Hebei Medical University Fourth Hospital, not yet recruiting.","summary":"A Clinical Study of Liposomal Irinotecan for Second-Line Therapy in Metastatic Colorectal Cancer is a phase 2/3, randomised interventional study registered as NCT07585279 by Hebei Medical University Fourth Hospital, with a registry enrolment figure of 408 participants, started 2026-05-20 and due to reach its primary completion in 2031-02-28. Interventions recorded: Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart; Irinotecan liposome + 5-FU/LV + Bevacizumab; Irinotecan + 5-FU/LV + Bevacizumab. Conditions listed: Metastatic Colorectal Cancer (CRC); Liposomal Irinotecan; Second-Line. Primary outcome: ORR. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed metastatic colon or rectal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07585279","url":"https://clinicaltrials.gov/study/NCT07585279"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["irinotecan","fluorouracil","leucovorin","bevacizumab-glioma","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07585279","phase":"2/3","setting":"Liposomal Irinotecan-based Regimen Versus Irinotecan-based Regimen in Second-Line Treatment for Metastatic Colorectal Cancer (IRIS-02): A Randomized, Controlled Phase II/III Study","sponsor":"Hebei Medical University Fourth Hospital","started":"2026-05-20","startedType":"estimated","enrolled":408,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06398444","kind":"trial","name":"A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms","aka":[],"tldr":"A phase 2/3 trial of Lutetium[177Lu] Oxodotreotide Injection in neuroendocrine tumours, run by Sinotau Pharmaceutical Group, now recruiting.","summary":"A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms is a phase 2/3 interventional study registered as NCT06398444 by Sinotau Pharmaceutical Group, with 85 participants planned, started 2024-06-11 and due to reach its primary completion in 2027-06-01. Interventions recorded: Lutetium[177Lu] Oxodotreotide Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06398444","url":"https://clinicaltrials.gov/study/NCT06398444"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sinotau-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06398444","phase":"2/3","setting":"A Clinical Study to Evaluate the Safety and Efficacy of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Somatostatin Receptor Positive Neuroendocrine Neoplasms","sponsor":"Sinotau Pharmaceutical Group","started":"2024-06-11","startedType":"actual","enrolled":85,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05579132","kind":"trial","name":"A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)","aka":[],"tldr":"A phase 1/2 trial of MK-1045 in acute lymphoblastic leukaemia, run by MSD R&D (China) Co., Ltd., now recruiting.","summary":"A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002) is a phase 1/2 interventional study registered as NCT05579132 by MSD R&D (China) Co., Ltd., with 203 participants planned, started 2022-11-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: MK-1045.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05579132","url":"https://clinicaltrials.gov/study/NCT05579132"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":[],"targets":[],"drugs":["mk-1045"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05579132","phase":"1/2","setting":"An Open-label, Multi-center Phase Ib/II Study of MK-1045 (CN201) in Subjects With Precursor B-cell Acute Lymphoblastic Leukemia","sponsor":"MSD R&D (China) Co., Ltd.","started":"2022-11-01","startedType":"actual","enrolled":203,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07519772","kind":"trial","name":"A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)","aka":["WaveSpan-008"],"tldr":"A phase 1/2 trial of MK-1045 in non-hodgkin lymphoma, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008) is a phase 1/2 interventional study registered as NCT07519772 by Merck Sharp & Dohme LLC, with 280 participants planned, started 2026-05-03 and due to reach its primary completion in 2030-07-01. Interventions recorded: MK-1045. Conditions listed: Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07519772","url":"https://clinicaltrials.gov/study/NCT07519772"}],"tags":["ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["mk-1045"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07519772","phase":"1/2","setting":"A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK-1045 Monotherapy or in Combination With Other Anticancer Agents in Participants With Non-Hodgkin Lymphoma","sponsor":"Merck Sharp & Dohme LLC","started":"2026-05-03","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07286149","kind":"trial","name":"A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)","aka":["KEYMAKER-U01"],"tldr":"A phase 1/2 trial of Calderasib, Patritumab deruxtecan, Sacituzumab tirumotecan and Cetuximab in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F) is a phase 1/2 interventional study registered as NCT07286149 by Merck Sharp & Dohme LLC, with 140 participants planned, started 2026-04-30 and due to reach its primary completion in 2029-08-17. Interventions recorded: MK-1084, Patritumab deruxtecan, Sacituzumab tirumotecan, Cetuximab and Rescue Medications.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07286149","url":"https://clinicaltrials.gov/study/NCT07286149"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["calderasib","patritumab-deruxtecan","sacituzumab-tirumotecan","cetuximab"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07286149","phase":"1/2","setting":"KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations","sponsor":"Merck Sharp & Dohme LLC","started":"2026-04-30","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06428409","kind":"trial","name":"A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)","aka":[],"tldr":"A phase 1/2 trial of Sacituzumab tirumotecan, Fluorouracil, FLOT in colorectal cancer and pancreatic ductal adenocarcinoma, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A) is a phase 1/2 interventional study registered as NCT06428409 by Merck Sharp & Dohme LLC, with 220 participants planned, started 2024-06-20 and due to reach its primary completion in 2029-10-16. Interventions recorded: Sacituzumab tirumotecan, Fluorouracil (5-FU), Leucovorin (LV) or levoleucovorin, Rescue medication, Supportive care measures. Conditions listed: Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06428409","url":"https://clinicaltrials.gov/study/NCT06428409"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["sacituzumab-tirumotecan","fluorouracil","flot","cisplatin","pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06428409","phase":"1/2","setting":"A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers","sponsor":"Merck Sharp & Dohme LLC","started":"2024-06-20","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07222488","kind":"trial","name":"A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)","aka":[],"tldr":"A phase 1/2 trial of MK-3120 in bladder & urothelial cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003) is a phase 1/2 interventional study registered as NCT07222488 by Merck Sharp & Dohme LLC, with 45 participants planned, started 2025-12-09 and due to reach its primary completion in 2029-02-28. Interventions recorded: MK-3120.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07222488","url":"https://clinicaltrials.gov/study/NCT07222488"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07222488","phase":"1/2","setting":"Phase 1/2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer","sponsor":"Merck Sharp & Dohme LLC","started":"2025-12-09","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07043725","kind":"trial","name":"A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer","aka":[],"tldr":"A phase 3 trial testing TQB2102 in HER2-positive breast cancer and HR-positive / HER2-negative breast cancer, now recruiting.","summary":"A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer is a phase 3 interventional study registered as NCT07043725, led by Chia Tai Tianqing Pharmaceutical Nanjing Shunxin Pharmaceutical, and recruiting on the registry. Official title: A Randomised, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression. Planned enrolment is 544 participants (estimated). The study started in 2025-09-15 and primary completion is expected in 2027-09. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07043725","url":"https://clinicaltrials.gov/study/NCT07043725"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","breast-hr-positive","her2-positive-early-breast-cancer","hr-positive-early-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb2102"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07043725","phase":"3","setting":"A Randomized, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression","sponsor":"Chia Tai Tianqing Pharmaceutical Nanjing Shunxin Pharmaceutical","started":"2025-09-15","startedType":"actual","enrolled":544,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07060807","kind":"trial","name":"A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)","aka":["HERTHENA-Breast04"],"tldr":"A phase 3 trial of Patritumab deruxtecan, Capecitabine, Doxorubicin and Trastuzumab deruxtecan in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016) is a phase 3 interventional study registered as NCT07060807 by Merck Sharp & Dohme LLC, with 1000 participants planned, started 2025-07-21 and due to reach its primary completion in 2033-07-14. Interventions recorded: Patritumab deruxtecan, Paclitaxel, Nab-paclitaxel, Capecitabine, Liposomal doxorubicin and Trastuzumab deruxtecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07060807","url":"https://clinicaltrials.gov/study/NCT07060807"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["patritumab-deruxtecan","capecitabine","doxorubicin","trastuzumab-deruxtecan"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07060807","phase":"3","setting":"An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04).","sponsor":"Merck Sharp & Dohme LLC","started":"2025-07-21","startedType":"actual","enrolled":1000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06698042","kind":"trial","name":"A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)","aka":[],"tldr":"A phase 3 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84) is a phase 3 interventional study registered as NCT06698042 by Merck Sharp & Dohme LLC, with 67 participants enrolled, started 2024-11-21 and due to reach its primary completion in 2026-03-12. Interventions recorded: Pembrolizumab (+) Berahyaluronidase alfa, Pembrolizumab. Conditions listed: Lung Cancer, Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06698042","url":"https://clinicaltrials.gov/study/NCT06698042"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06698042","phase":"3","setting":"A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS 50% or Greater","sponsor":"Merck Sharp & Dohme LLC","started":"2024-11-21","startedType":"actual","enrolled":67,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06431243","kind":"trial","name":"A Clinical Study of Purinostat Mesylate for Injection in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Purinostat in advanced solid tumours, run by Chengdu Zenitar Biomedical Technology Co., Ltd, now recruiting.","summary":"A Clinical Study of Purinostat Mesylate for Injection in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06431243 by Chengdu Zenitar Biomedical Technology Co., Ltd, with 132 participants planned, started 2024-05-08 and due to reach its primary completion in 2026-05-01. Interventions recorded: A0/B0 group Purinostat Mesylate 11.2mg/m2, A0/B0 group Purinostat Mesylate 15mg/m2, A group Purinostat Mesylate 6mg/m2, A group Purinostat Mesylate 8.4mg/m2, A group Purinostat Mesylate 11.2mg/m2 and A group Purinostat Mesylate 15 mg/m2.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06431243","url":"https://clinicaltrials.gov/study/NCT06431243"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["purinostat"],"companies":["chengdu-zenitar-biomedical-technology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06431243","phase":"1/2","setting":"An Open, Multicenter Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the Purinostat Mesylate for Injection in Combination Therapy for Advanced Solid Tumors","sponsor":"Chengdu Zenitar Biomedical Technology Co., Ltd","started":"2024-05-08","startedType":"actual","enrolled":132,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07198633","kind":"trial","name":"A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer","aka":[],"tldr":"A phase 1/2 trial of QLC5508, Abiraterone acetate, Enzalutamide in prostate cancer, run by Qilu Pharmaceutical Co., Ltd., now recruiting.","summary":"A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer is a phase 1/2 interventional study registered as NCT07198633 by Qilu Pharmaceutical Co., Ltd., with 212 participants planned, started 2025-11-05 and due to reach its primary completion in 2026-12. Interventions recorded: QLC5508, abiraterone acetate, enzalutamide, QLH12016. Conditions listed: Advanced Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07198633","url":"https://clinicaltrials.gov/study/NCT07198633"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["qlc5508","abiraterone","enzalutamide","qlh12016"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07198633","phase":"1/2","setting":"An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2025-11-05","startedType":"actual","enrolled":212,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06843447","kind":"trial","name":"A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)","aka":["REJOICE-Ovarian02"],"tldr":"A phase 1/2 trial of Raludotatug deruxtecan, Carboplatin, Paclitaxel / nab-paclitaxel in ovarian cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003) is a phase 1/2 interventional study registered as NCT06843447 by Merck Sharp & Dohme LLC, with 605 participants planned, started 2025-04-15 and due to reach its primary completion in 2029-03-27. Interventions recorded: Raludotatug Deruxtecan, Carboplatin, Paclitaxel, Bevacizumab, Rescue Medication. Conditions listed: Ovarian Cancer Recurrent. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06843447","url":"https://clinicaltrials.gov/study/NCT06843447"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["raludotatug-deruxtecan","carboplatin","paclitaxel","bevacizumab","pembrolizumab","gemcitabine"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06843447","phase":"1/2","setting":"A Phase 1b/2 Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan With or Without Other Anticancer Investigational Agents in Participants With Advanced High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (REJOICE-Ovarian02)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-04-15","startedType":"actual","enrolled":605,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07216703","kind":"trial","name":"A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Canc","aka":["TroFuse-036"],"tldr":"A phase 3 trial of Pembrolizumab, Sacituzumab tirumotecan, Bevacizumab in cervical cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22) is a phase 3 interventional study registered as NCT07216703 by Merck Sharp & Dohme LLC, with 1023 participants planned, started 2026-01-19 and due to reach its primary completion in 2031-10-29. Interventions recorded: Pembrolizumab, Sacituzumab Tirumotecan, Bevacizumab, Paclitaxel, Cisplatin. Conditions listed: Cervical Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07216703","url":"https://clinicaltrials.gov/study/NCT07216703"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["adc","antiangiogenic","checkpoint-inhibitor","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["pembrolizumab","sacituzumab-tirumotecan","bevacizumab","paclitaxel","cisplatin","carboplatin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07216703","phase":"3","setting":"A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)","sponsor":"Merck Sharp & Dohme LLC","started":"2026-01-19","startedType":"actual","enrolled":1023,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06637423","kind":"trial","name":"A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)","aka":["TroFuse-027"],"tldr":"A phase 1/2 trial of Sacituzumab tirumotecan in bladder & urothelial cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027) is a phase 1/2 interventional study registered as NCT06637423 by Merck Sharp & Dohme LLC, with 32 participants planned, started 2024-12-20 and due to reach its primary completion in 2029-03-14. Interventions recorded: Sacituzumab tirumotecan, Rescue medication and Supportive care measures.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06637423","url":"https://clinicaltrials.gov/study/NCT06637423"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06637423","phase":"1/2","setting":"A Phase 1/2 Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravesical Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (NMIBC)","sponsor":"Merck Sharp & Dohme LLC","started":"2024-12-20","startedType":"actual","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06966700","kind":"trial","name":"A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)","aka":[],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Pembrolizumab, Carboplatin, Doxorubicin, Epirubicin and Cyclophosphamide in triple-negative breast cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) is a phase 3 interventional study registered as NCT06966700 by Merck Sharp & Dohme LLC, with 2400 participants planned, started 2025-06-30 and due to reach its primary completion in 2033-03-23. Interventions recorded: Sacituzumab tirumotecan, Pembrolizumab, Rescue Medication, Carboplatin, Paclitaxel and Doxorubicin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06966700","url":"https://clinicaltrials.gov/study/NCT06966700"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["adc","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","pembrolizumab","carboplatin","doxorubicin","epirubicin","cyclophosphamide"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06966700","phase":"3","setting":"A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer","sponsor":"Merck Sharp & Dohme LLC","started":"2025-06-30","startedType":"actual","enrolled":2400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07609251","kind":"trial","name":"A Clinical Study of SCTB41 Combined With Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer（Phase II Study","aka":[],"tldr":"A phase 2 trial of SCTB41 and docetaxel in lung cancer, run by Sinocelltech Ltd., not yet recruiting.","summary":"A Clinical Study of SCTB41 Combined With Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer（Phase II Study Ongoing） is a phase 2, interventional study registered as NCT07609251 by Sinocelltech Ltd., with a registry enrolment figure of 90 participants, started 2026-05 and due to reach its primary completion in 2028-10. Interventions recorded: SCTB41; docetaxel. Conditions listed: NSCLC (Advanced Non-small Cell Lung Cancer). Primary outcome: Frequency of adverse events (AEs). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and cannot receive curative concurrent/sequential chemoradiotherapy;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07609251","url":"https://clinicaltrials.gov/study/NCT07609251"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["sctb41","docetaxel"],"companies":["sinocelltech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07609251","phase":"2","setting":"A Phase II/III Study of SCTB41 Plus Docetaxel vs Placebo Plus Docetaxel in Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Sinocelltech Ltd.","started":"2026-05","startedType":"estimated","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06643754","kind":"trial","name":"A Clinical Study of SHR-3276 for Injection in Patients With Advanced Malignant Tumors","aka":[],"tldr":"A phase 1/2 trial of SHR-3276 in advanced solid tumours, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Clinical Study of SHR-3276 for Injection in Patients With Advanced Malignant Tumors is a phase 1/2 interventional study registered as NCT06643754 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 115 participants planned, started 2024-12-10 and due to reach its primary completion in 2027-12-30. Interventions recorded: SHR-3276.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06643754","url":"https://clinicaltrials.gov/study/NCT06643754"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06643754","phase":"1/2","setting":"A Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-3276 Injection in Patients With Advanced Malignant Tumors","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2024-12-10","startedType":"actual","enrolled":115,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07407283","kind":"trial","name":"A Clinical Study of SHR-4394 in Combination With Anti-tumor Therapy in Prostate Cancer","aka":[],"tldr":"A phase 1/2 trial of Rezvilutamide, Tazemetostat in prostate cancer, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Clinical Study of SHR-4394 in Combination With Anti-tumor Therapy in Prostate Cancer is a phase 1/2 interventional study registered as NCT07407283 by Jiangsu HengRui Medicine Co., Ltd., with 100 participants planned, started 2026-04-08 and due to reach its primary completion in 2027-11. Interventions recorded: SHR-4394, Rezvilutamide, HRS-5041 Tablets, Tazemetostat. Conditions listed: Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07407283","url":"https://clinicaltrials.gov/study/NCT07407283"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["rezvilutamide","tazemetostat"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07407283","phase":"1/2","setting":"A Multicenter, Open-label, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of SHR-4394 in Combination With Anti-tumor Therapy in Participants With Prostate Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2026-04-08","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06840002","kind":"trial","name":"A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer","aka":[],"tldr":"A phase 1/2 trial of Trastuzumab rezetecan, Carboplatin, Bevacizumab in ovarian cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer is a phase 1/2 interventional study registered as NCT06840002 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 150 participants planned, started 2025-03-18 and due to reach its primary completion in 2026-12. Interventions recorded: SHR-A1811, Carboplatin, Bevacizumab, Oxaliplatin for Injection, Paclitaxel injection. Conditions listed: Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06840002","url":"https://clinicaltrials.gov/study/NCT06840002"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","carboplatin","bevacizumab","capox","paclitaxel","adebrelimab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06840002","phase":"1/2","setting":"An Open, Multicenter Phase Ib / II Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-03-18","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07676162","kind":"trial","name":"A Clinical Study of SHR-A1811 in Combination With Chemotherapy and Bevacizumab Versus Standard Therapy as First-Line Treatment for Advanced Colorectal","aka":[],"tldr":"A phase 3 trial of Trastuzumab rezetecan, CAPOX, Fluorouracil in colorectal cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Clinical Study of SHR-A1811 in Combination With Chemotherapy and Bevacizumab Versus Standard Therapy as First-Line Treatment for Advanced Colorectal Cancer is a phase 3 interventional study registered as NCT07676162 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 300 participants planned, started 2026-08-28 and due to reach its primary completion in 2029-09. Interventions recorded: SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab. Conditions listed: Advanced Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07676162","url":"https://clinicaltrials.gov/study/NCT07676162"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["adc","antiangiogenic","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","capox","fluorouracil","bevacizumab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07676162","phase":"3","setting":"A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study of SHR-A1811 in Combination With mFOLFOX6 (-1) and Bevacizumab Versus mFOLFOX6 in Combination With Bevacizumab as First-line Treatment for Advanced Colorectal Cancer.","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2026-08-28","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06778031","kind":"trial","name":"A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of Trastuzumab rezetecan, Adebrelimab and SHR-8068 in biliary tract cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer is a phase 2 interventional study registered as NCT06778031 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 54 participants planned, started 2025-02-26 and due to reach its primary completion in 2028-06. Interventions recorded: SHR-A1811, SHR-1316 and SHR-8068.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06778031","url":"https://clinicaltrials.gov/study/NCT06778031"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","adebrelimab","shr-8068"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06778031","phase":"2","setting":"An Open, Multicenter Phase II Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-02-26","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05943795","kind":"trial","name":"A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma","aka":[],"tldr":"A phase 3 trial of SI-B001 and docetaxel in lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., active but no longer recruiting.","summary":"A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma is a phase 3, randomised interventional study registered as NCT05943795 by Sichuan Baili Pharmaceutical Co., Ltd., with a registry enrolment figure of 589 participants, started 2023-07-14 and due to reach its primary completion in 2026-07. Interventions recorded: SI-B001; Docetaxel. Conditions listed: Non-small Cell Lung Adenocarcinoma; Squamous Cell Carcinoma of Lung. Primary outcome: Overall survival (OS); Progression-free survival (PFS). Lung eligibility wording from the registry: \"Patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05943795","url":"https://clinicaltrials.gov/study/NCT05943795"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-squamous-cell-carcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["si-b001","docetaxel"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05943795","phase":"3","setting":"A Phase III Clinical Study of SI-B001 Combined With Docetaxel Second-line Therapy in Patients With Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma Without Actionable Genomic Alterations Who Failed Only First-line Treatment With PD-1/PD-L1 Monoclonal Antibody Plus Platinum-Based Chemotherapy","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-07-14","startedType":"actual","enrolled":589,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05054439","kind":"trial","name":"A Clinical Study of SI-B001 in Combination With Paclitaxel/Docetaxel in the Treatment of Recurrent and Metastatic HNSCC","aka":[],"tldr":"A phase 2 trial of SI-B001, Paclitaxel / nab-paclitaxel, Docetaxel in head and neck squamous cell carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Clinical Study of SI-B001 in Combination With Paclitaxel/Docetaxel in the Treatment of Recurrent and Metastatic HNSCC is a phase 2 interventional study registered as NCT05054439 by Sichuan Baili Pharmaceutical Co., Ltd., with 45 participants enrolled, started 2021-12-22 and due to reach its primary completion in 2026-12. Interventions recorded: SI-B001, Paclitaxel, docetaxel. Conditions listed: Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05054439","url":"https://clinicaltrials.gov/study/NCT05054439"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["si-b001","paclitaxel","docetaxel"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05054439","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in Combination With Paclitaxel/Docetaxel in the Treatment of Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2021-12-22","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06434597","kind":"trial","name":"A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.","aka":[],"tldr":"A phase 2 trial of SPH5030 in colorectal cancer, run by Shanghai Pharmaceuticals Holding Co., Ltd, now recruiting.","summary":"A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients. is a phase 2 interventional study registered as NCT06434597 by Shanghai Pharmaceuticals Holding Co., Ltd, with 60 participants planned, started 2024-07-17 and due to reach its primary completion in 2026-12-31. Interventions recorded: SPH5030.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06434597","url":"https://clinicaltrials.gov/study/NCT06434597"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","her2-amplified-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06434597","phase":"2","setting":"A Multicenter, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH5030 Tablets in Subjects With Her2-positive/Mutated Biliary Tract OR Colorectal Cancer.","sponsor":"Shanghai Pharmaceuticals Holding Co., Ltd","started":"2024-07-17","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07597629","kind":"trial","name":"A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer","aka":[],"tldr":"A phase 2 trial of SYS6023 and KN026 in advanced solid tumours, run by CSPC Megalith Biopharmaceutical Co.,Ltd., now recruiting.","summary":"A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer is a phase 2 interventional study registered as NCT07597629 by CSPC Megalith Biopharmaceutical Co.,Ltd., with 36 participants planned, started 2026-05-25 and due to reach its primary completion in 2027-11-30. Interventions recorded: SYS6023 and KN026.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07597629","url":"https://clinicaltrials.gov/study/NCT07597629"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["sys6023","kn026"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07597629","phase":"2","setting":"A Phase II Clinical Study Evaluating the Efficacy and Safety of SYS6023 Combination Therapy for Unresectable Locally Advanced or Metastatic Breast Cancer","sponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","started":"2026-05-25","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07714668","kind":"trial","name":"A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer","aka":[],"tldr":"A phase 2 trial of Farletuzumab-exatecan, Bevacizumab, Carboplatin in ovarian cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd., now recruiting.","summary":"A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer is a phase 2 interventional study registered as NCT07714668 by CSPC Megalith Biopharmaceutical Co.,Ltd., with 171 participants planned, started 2026-08-13 and due to reach its primary completion in 2028-04-30. Interventions recorded: SYS6041, bevacizumab, SYS6041, carboplatin, bevacizumab, paclitaxel, carboplatin, bevacizumab, SYS6041, enlonstobart, bevacizumab. Conditions listed: Ovarian Cancer, Recurrent Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07714668","url":"https://clinicaltrials.gov/study/NCT07714668"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["farletuzumab-exatecan","bevacizumab","carboplatin","paclitaxel"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07714668","phase":"2","setting":"An Open-label , Multicenter, Multicohort, Phase II Clinical Study Evaluating the Efficacy and Safety of SYS6041 Combination Therapy for Recurrent Ovarian Cancer","sponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","started":"2026-08-13","startedType":"actual","enrolled":171,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06214143","kind":"trial","name":"A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of T3011 high dose in advanced solid tumours, run by Shanghai Pharmaceuticals Holding Co., Ltd, now recruiting.","summary":"A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06214143 by Shanghai Pharmaceuticals Holding Co., Ltd, with 68 participants planned, started 2024-01-11 and due to reach its primary completion in 2026-12-31. Interventions recorded: T3011 high dose, T3011 middle dose and T3011 low dose.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06214143","url":"https://clinicaltrials.gov/study/NCT06214143"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06214143","phase":"1/2","setting":"A Single-arm, Multi-center Phase Ib/IIa Clinical Study to Evaluate the Tolerability, Safety, and Initial Efficacy of T3011 Herpesvirus Injection Combined With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors","sponsor":"Shanghai Pharmaceuticals Holding Co., Ltd","started":"2024-01-11","startedType":"actual","enrolled":68,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06340568","kind":"trial","name":"A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer","aka":["Fern-EC-01"],"tldr":"A phase 3 trial of Trastuzumab pamirtecan, Doxorubicin, Paclitaxel / nab-paclitaxel in endometrial cancer, run by BioNTech SE, now recruiting.","summary":"A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer is a phase 3 interventional study registered as NCT06340568 by BioNTech SE, with 480 participants planned, started 2025-06-10 and due to reach its primary completion in 2028-03. Interventions recorded: BNT323/DB-1303, Doxorubicin, Paclitaxel, Docetaxel. Conditions listed: Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06340568","url":"https://clinicaltrials.gov/study/NCT06340568"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-pamirtecan","doxorubicin","paclitaxel","docetaxel"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06340568","phase":"3","setting":"A Phase III, Randomized, Multi-site, Open-label Trial of BNT323/DB-1303 Versus Investigator's Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent Endometrial Cancer","sponsor":"BioNTech SE","started":"2025-06-10","startedType":"actual","enrolled":480,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07003074","kind":"trial","name":"A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial testing TQB2102 in HR-positive / HER2-negative breast cancer and HER2-positive breast cancer, now recruiting.","summary":"A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer is a phase 3 interventional study registered as NCT07003074, led by Chia Tai Tianqing Pharmaceutical Nanjing Shunxin Pharmaceutical, and recruiting on the registry. Official title: A Randomised, Open, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) Positive Recurrent or Metastatic Breast Cancer. Planned enrolment is 642 participants (estimated). The study started in 2025-06-23 and primary completion is expected in 2029-07. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07003074","url":"https://clinicaltrials.gov/study/NCT07003074"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb2102"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07003074","phase":"3","setting":"A Randomized, Open, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) Positive Recurrent or Metastatic Breast Cancer","sponsor":"Chia Tai Tianqing Pharmaceutical Nanjing Shunxin Pharmaceutical","started":"2025-06-23","startedType":"actual","enrolled":642,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06469879","kind":"trial","name":"A Clinical Study of TQB2450 Combined With Anlotinib in Limited-Stage Small Cell Lung Cancer Patients","aka":[],"tldr":"A phase 3 trial of benmelstobart and anlotinib in lung cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., not yet recruiting.","summary":"A Clinical Study of TQB2450 Combined With Anlotinib in Limited-Stage Small Cell Lung Cancer Patients is a phase 3, randomised interventional study registered as NCT06469879 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with a registry enrolment figure of 358 participants, started 2024-09 and due to reach its primary completion in 2026-09. Interventions recorded: TQB2450+Anlotinib; TQB2450 placebo + Anlotinib placebo. Conditions listed: Small Cell Lung Cancer Limited Stage. Primary outcome: Progression-free survival (PFS) evaluated by the Independent Review Committee (IRC). Lung eligibility wording from the registry: \"* Pathologically confirmed patients with limited stage small cell lung cancer (according to the Veterans Administration Lung Study Group (VALG) stage);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06469879","url":"https://clinicaltrials.gov/study/NCT06469879"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["limited-stage-sclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["benmelstobart","anlotinib"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06469879","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2450 Combined With Anlotinib as Maintenance Therapy in Patients With Limited-stage Small Cell Lung Cancer","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2024-09","startedType":"estimated","enrolled":358,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05913089","kind":"trial","name":"A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of TQB2450, Anlotinib in non-small-cell lung cancer and small-cell lung cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., now recruiting.","summary":"A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer is a phase 2 interventional study registered as NCT05913089 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with 58 participants planned, started 2023-06-14 and due to reach its primary completion in 2026-06. Interventions recorded: TQB2450 injection + Chemotherapy, TQB2450 injection + Anlotinib Hydrochloride Capsule. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05913089","url":"https://clinicaltrials.gov/study/NCT05913089"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["tqb2450","anlotinib"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05913089","phase":"2","setting":"A Phase II/III Clinical Study on the Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Perioperative Treatment of Resectable Stage II/III Non Small Cell Lung Cancer.","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2023-06-14","startedType":"actual","enrolled":58,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05987358","kind":"trial","name":"A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma","aka":[],"tldr":"A phase 3 trial testing TQB3454 in biliary tract cancer, active and no longer recruiting.","summary":"A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma is a phase 3 interventional study registered as NCT05987358, led by Chia Tai Tianqing Pharmaceutical, and active but no longer recruiting on the registry. Official title: A Randomised, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation. Planned enrolment is 165 participants (estimated). The study started in 2023-09-21 and primary completion is expected in 2026-12. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05987358","url":"https://clinicaltrials.gov/study/NCT05987358"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma","intrahepatic-cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb3454"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05987358","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation","sponsor":"Chia Tai Tianqing Pharmaceutical","started":"2023-09-21","startedType":"actual","enrolled":165,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06459973","kind":"trial","name":"A Clinical Study of YL205 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of intravenous (IV) infusion in advanced solid tumours, run by MediLink Therapeutics (Suzhou) Co., Ltd., now recruiting.","summary":"A Clinical Study of YL205 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06459973 by MediLink Therapeutics (Suzhou) Co., Ltd., with 252 participants planned, started 2024-06-04 and due to reach its primary completion in 2027-07-31. Interventions recorded: intravenous (IV) infusion.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06459973","url":"https://clinicaltrials.gov/study/NCT06459973"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06459973","phase":"1/2","setting":"A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of YL205 in Patients With Advanced Solid Tumors","sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","started":"2024-06-04","startedType":"actual","enrolled":252,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06890884","kind":"trial","name":"A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)","aka":[],"tldr":"A phase 2 trial of Zilovertamab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone and Polatuzumab vedotin in diffuse large B-cell lymphoma, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011) is a phase 2 interventional study registered as NCT06890884 by Merck Sharp & Dohme LLC, with 594 participants planned, started 2025-04-11 and due to reach its primary completion in 2027-12-13. Interventions recorded: Zilovertamab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Rituximab Biosimilar and Prednisone.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06890884","url":"https://clinicaltrials.gov/study/NCT06890884"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["zilovertamab-vedotin","rituximab","cyclophosphamide","doxorubicin","prednisone","polatuzumab-vedotin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06890884","phase":"2","setting":"A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-04-11","startedType":"actual","enrolled":594,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06979908","kind":"trial","name":"A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal C","aka":[],"tldr":"A phase 2 trial of fruquintinib, sintilimab and tucidinostat (chidamide) in colorectal cancer, run by The First Hospital of Jilin University, now recruiting.","summary":"A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06979908 by The First Hospital of Jilin University, with a registry enrolment figure of 46 participants, started 2025-01-22 and due to reach its primary completion in 2026-07-22. Interventions recorded: Fruquintinib+Sintilimab+Chidamide. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: PFS. Colorectal eligibility wording from the registry: \"* Histologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06979908","url":"https://clinicaltrials.gov/study/NCT06979908"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib","sintilimab","tucidinostat"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06979908","phase":"2","setting":"A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal Cancer","sponsor":"The First Hospital of Jilin University","started":"2025-01-22","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06982924","kind":"trial","name":"A Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib as First-line Treatment for NSCLC.","aka":["LIBRA"],"tldr":"A phase 2 trial of limertinib and bevacizumab in lung cancer, run by Shanghai Chest Hospital, not yet recruiting.","summary":"A Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib as First-line Treatment for NSCLC. is a phase 2, randomised interventional study registered as NCT06982924 by Shanghai Chest Hospital, with a registry enrolment figure of 136 participants, started 2025-06-30 and due to reach its primary completion in 2026-12-30. Interventions recorded: Limertinib+bevacizumab; Limertinib. Conditions listed: EGFR Mutation Positive Advanced Non Small Cell Lung Cancer; PD-L1 Positive. Primary outcome: PFS. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed non - squamous non - small cell lung cancer (NSCLC)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06982924","url":"https://clinicaltrials.gov/study/NCT06982924"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["limertinib","bevacizumab"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06982924","phase":"2","setting":"A Prospective, Controlled Phase II Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib Monotherapy as First - Line Treatment for Locally Advanced or Recurrent Metastatic Non - Squamous NSCLC With EGFR Mutations and High PD-L1 Expression.","sponsor":"Shanghai Chest Hospital","started":"2025-06-30","startedType":"estimated","enrolled":136,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06962267","kind":"trial","name":"A Clinical Study on the First-line Treatment of Metastatic Pancreatic Cancer With TQB2916 Injection Combined With Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (Albumin-bound Type)","aka":[],"tldr":"A phase 2 trial of TQB2916 Injection in pancreatic ductal adenocarcinoma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., now recruiting.","summary":"A Clinical Study on the First-line Treatment of Metastatic Pancreatic Cancer With TQB2916 Injection Combined With Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (Albumin-bound Type) is a phase 2 interventional study registered as NCT06962267 by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., with 50 participants planned, started 2025-04-18 and due to reach its primary completion in 2027-08. Interventions recorded: TQB2916 Injection and Chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06962267","url":"https://clinicaltrials.gov/study/NCT06962267"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06962267","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of TQB2916 Injection Combined With Gemcitabine and Albumin-paclitaxel as First-line Treatment for Metastatic Pancreatic Cance","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","started":"2025-04-18","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07395063","kind":"trial","name":"A Clinical Study on the Treatment of Metastatic Colorectal Cancer at the Second-line or Beyond.","aka":[],"tldr":"A phase 2 trial of camrelizumab in colorectal cancer, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine, not yet recruiting.","summary":"A Clinical Study on the Treatment of Metastatic Colorectal Cancer at the Second-line or Beyond. is a phase 2, interventional study registered as NCT07395063 by The Fourth Affiliated Hospital of Zhejiang University School of Medicine, with a registry enrolment figure of 68 participants, started 2026-02-01 and due to reach its primary completion in 2029-02-01. Interventions recorded: Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab. Conditions listed: Metastatic Colorectal Cancer (CRC). Primary outcome: Progression-free survival (PFS）. Colorectal eligibility wording from the registry: \"* Patients pathologically diagnosed with colorectal cancer;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07395063","url":"https://clinicaltrials.gov/study/NCT07395063"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["camrelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07395063","phase":"2","setting":"A Single-arm, Open-label Clinical Study of Irinotecan Liposome Combined With Capecitabine, Bevacizumab and Camrelizumab as Second-line or Higher Treatment for Patients With Metastatic Colorectal Cancer","sponsor":"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","started":"2026-02-01","startedType":"estimated","enrolled":68,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06931717","kind":"trial","name":"A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Re","aka":["ARCH"],"tldr":"A phase 3 trial of cemiplimab in lung cancer, run by ETOP IBCSG Partners Foundation, now recruiting.","summary":"A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior Chemotherapy is a phase 3, randomised interventional study registered as NCT06931717 by ETOP IBCSG Partners Foundation, with a registry enrolment figure of 390 participants, started 2026-01-12 and due to reach its primary completion in 2029-03. Interventions recorded: Cemiplimab. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Disease-free survival (DFS). Lung eligibility wording from the registry: \"* Pathological stage II-IIIA (UICC/ AJCC staging 9th edition) NSCLC Brain imaging should have been performed to complete staging, either preoperatively or postoperatively\". Sites: Austria, Estonia, France, Germany, Ireland, Italy, Singapore, Spain, Switzerland. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06931717","url":"https://clinicaltrials.gov/study/NCT06931717"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06931717","phase":"3","setting":"A Randomised Phase III Trial of Adjuvant Cemiplimab in Patients With Resected Stage II-IIIA NSCLC Who Have Not Received Prior Adjuvant Chemotherapy","sponsor":"ETOP IBCSG Partners Foundation","started":"2026-01-12","startedType":"actual","enrolled":390,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07672236","kind":"trial","name":"A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.","aka":["BEAM-Pain"],"tldr":"A phase 3 trial of BupiZenge 25 mg in advanced solid tumours, run by OncoZenge AB, now recruiting.","summary":"A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer. is a phase 3 interventional study registered as NCT07672236 by OncoZenge AB, with 150 participants planned, started 2026-07-07 and due to reach its primary completion in 2026-12-23. Interventions recorded: BupiZenge 25 mg and Lidocaine viscous 2%.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07672236","url":"https://clinicaltrials.gov/study/NCT07672236"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07672236","phase":"3","setting":"A Randomized, Open-label, Phase III Trial to Assess the Efficacy and Safety of BupiZenge Compared to Lidocaine for Pain Associated With Oral Mucositis in Head and Neck Cancer","sponsor":"OncoZenge AB","started":"2026-07-07","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04547166","kind":"trial","name":"A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Meta","aka":[],"tldr":"A phase 2/3 trial of Serplulimab, Bevacizumab in colorectal cancer, run by Shanghai Henlius Biotech, now recruiting.","summary":"A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC) is a phase 2/3 interventional study registered as NCT04547166 by Shanghai Henlius Biotech, with 568 participants planned, started 2021-03-10 and due to reach its primary completion in 2025-09-24. Interventions recorded: HLX10, HLX04、. Conditions listed: Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04547166","url":"https://clinicaltrials.gov/study/NCT04547166"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["serplulimab","bevacizumab"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04547166-med-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04547166","phase":"2/3","setting":"A Randomized, Double-blind, Multicenter, PhaseⅡ/Ⅲ Clinical Study of Serplulimab in Combination With Bevacizumab and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)","sponsor":"Shanghai Henlius Biotech","started":"2021-03-10","startedType":"actual","enrolled":568,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07483684","kind":"trial","name":"A Clinical Study to Evaluate Injection TQB2102 for the Treatment of Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxal","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., not yet recruiting.","summary":"A Clinical Study to Evaluate Injection TQB2102 for the Treatment of Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs is a phase 3, randomised interventional study registered as NCT07483684 by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., with a registry enrolment figure of 142 participants, started 2026-03 and due to reach its primary completion in 2027-08. Interventions recorded: TQB2102 Injection; Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tablets. Conditions listed: HER2 IHC3+ Advanced Colorectal Cancer. Primary outcome: Progression-Free Survival (PFS) assessed by IRC based on RECIST v1.1. Colorectal eligibility wording from the registry: \"* Subjects with histologically or cytologically confirmed advanced colorectal cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07483684","url":"https://clinicaltrials.gov/study/NCT07483684"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","her2-amplified-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07483684","phase":"3","setting":"A Randomized, Open-Label, Active-Controlled, Multicenter Phase III Clinical Study to Evaluate Injection TQB2102 Versus Investigator's Choice of Treatment Regimens in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","started":"2026-03","startedType":"estimated","enrolled":142,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04024696","kind":"trial","name":"A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese Patients","aka":[],"tldr":"A phase 1/2 trial of Abexinostat in hodgkin lymphoma and non-hodgkin lymphoma, run by Xynomic Pharmaceuticals, Inc., active and no longer recruiting.","summary":"A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese Patients is a phase 1/2 interventional study registered as NCT04024696 by Xynomic Pharmaceuticals, Inc., with 12 participants enrolled, started 2020-01-08 and due to reach its primary completion in 2024-12-30. Interventions recorded: Abexinostat. Conditions listed: Non Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04024696","url":"https://clinicaltrials.gov/study/NCT04024696"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["abexinostat"],"companies":["xynomic-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04024696","phase":"1/2","setting":"An Open-Label, Non-Randomized Clinical Study to Evaluate Pharmacokinetic (PK) Profiles, Safety, and Tolerability of Abexinostat Monotherapy in Patients With Non-Hodgkin's Lymphoma Who Have Failed Standard of Care","sponsor":"Xynomic Pharmaceuticals, Inc.","started":"2020-01-08","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06959693","kind":"trial","name":"A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-βand mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Col","aka":[],"tldr":"A phase 2/3 trial of envafolimab and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-βand mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC) is a phase 2/3, randomised interventional study registered as NCT06959693 by Sun Yat-sen University, with a registry enrolment figure of 590 participants, started 2025-06-01 and due to reach its primary completion in 2028-09-30. Interventions recorded: Cetuxima-β; Envafolimab; mFOLFOX6. Conditions listed: Metastatic Colorectal Cancer (CRC). Primary outcome: Progressin Free Survival，PFS. Colorectal eligibility wording from the registry: \"Histopathologically confirmed untreated advanced colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06959693","url":"https://clinicaltrials.gov/study/NCT06959693"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["envafolimab","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06959693","phase":"2/3","setting":"mFOLFOX and Cetuximab - β With or Without Envafolimab for MSS, RAS/BRAF Wild - Type Advanced Unresectable CRC: Prospective, Randomized, Controlled Phase II/III Trial","sponsor":"Sun Yat-sen University","started":"2025-06-01","startedType":"estimated","enrolled":590,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05787613","kind":"trial","name":"A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients","aka":[],"tldr":"A phase 2 trial of HLX26 and Serplulimab in non-small-cell lung cancer, run by Shanghai Henlius Biotech, active and no longer recruiting.","summary":"A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients is a phase 2 interventional study registered as NCT05787613 by Shanghai Henlius Biotech, with 132 participants enrolled, started 2023-07-10 and due to reach its primary completion in 2026-02. Interventions recorded: HLX26, Serplulimab, Chemotherapy drug and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05787613","url":"https://clinicaltrials.gov/study/NCT05787613"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["hlx26","serplulimab"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05787613","phase":"2","setting":"A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab (Anti-PD-1 Humanized Monoclonal Antibody Injection) and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) Patients","sponsor":"Shanghai Henlius Biotech","started":"2023-07-10","startedType":"actual","enrolled":132,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05044897","kind":"trial","name":"A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC","aka":[],"tldr":"A phase 2 trial of SI-B001 in head and neck squamous cell carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC is a phase 2 interventional study registered as NCT05044897 by Sichuan Baili Pharmaceutical Co., Ltd., with 11 participants enrolled, started 2021-10-20 and due to reach its primary completion in 2025-12. Interventions recorded: SI-B001. Conditions listed: Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05044897","url":"https://clinicaltrials.gov/study/NCT05044897"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["si-b001"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05044897","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2021-10-20","startedType":"actual","enrolled":11,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06566586","kind":"trial","name":"A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma","aka":[],"tldr":"A phase 2 trial of TQB3702 tablets+Chemotherapy regimen in non-Hodgkin lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., now recruiting.","summary":"A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma is a phase 2 interventional study registered as NCT06566586 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with 80 participants planned, started 2024-11-06 and due to reach its primary completion in 2026-03. Interventions recorded: TQB3702 tablets+Chemotherapy regimen.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06566586","url":"https://clinicaltrials.gov/study/NCT06566586"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb3702"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06566586","phase":"2","setting":"A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2024-11-06","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07222969","kind":"trial","name":"A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of VIB305 for Injection in advanced solid tumours, run by Vibrant Sciences Limited, now recruiting.","summary":"A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07222969 by Vibrant Sciences Limited, with 146 participants planned, started 2026-01-12 and due to reach its primary completion in 2027-04-30. Interventions recorded: VIB305 for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07222969","url":"https://clinicaltrials.gov/study/NCT07222969"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07222969","phase":"1/2","setting":"An Open-label, Dose-escalation and Dose-expansion Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Efficacy of VIB305 in Patients With Advanced Solid Tumors","sponsor":"Vibrant Sciences Limited","started":"2026-01-12","startedType":"actual","enrolled":146,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06827236","kind":"trial","name":"A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of Trastuzumab pamirtecan and PM8002 in advanced solid tumours, run by BioNTech SE, now recruiting.","summary":"A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer is a phase 1/2 interventional study registered as NCT06827236 by BioNTech SE, with 380 participants planned, started 2025-04-23 and due to reach its primary completion in 2029-08. Interventions recorded: BNT323 and BNT327.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06827236","url":"https://clinicaltrials.gov/study/NCT06827236"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-pamirtecan","pm8002"],"companies":["biontech","dualitybio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06827236","phase":"1/2","setting":"A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer","sponsor":"BioNTech SE","started":"2025-04-23","startedType":"actual","enrolled":380,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06892548","kind":"trial","name":"A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of BNT324 and PM8002 in advanced solid tumours, run by BioNTech SE, now recruiting.","summary":"A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer is a phase 1/2 interventional study registered as NCT06892548 by BioNTech SE, with 594 participants planned, started 2025-05-02 and due to reach its primary completion in 2028-09. Interventions recorded: BNT324 and BNT327.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06892548","url":"https://clinicaltrials.gov/study/NCT06892548"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["bnt324","pm8002"],"companies":["biontech","dualitybio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06892548","phase":"1/2","setting":"A Phase Ib/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Recommended Combination Dose of BNT324 With BNT327 in Participants With Advanced Lung Cancer","sponsor":"BioNTech SE","started":"2025-05-02","startedType":"actual","enrolled":594,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05755113","kind":"trial","name":"A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma","aka":[],"tldr":"A phase 2 trial of Tigilanol Tiglate in sarcomas, run by QBiotics Group Limited, now recruiting.","summary":"A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma is a phase 2 interventional study registered as NCT05755113 by QBiotics Group Limited, with 40 participants planned, started 2023-04-13 and due to reach its primary completion in 2027-01. Interventions recorded: Tigilanol Tiglate.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05755113","url":"https://clinicaltrials.gov/study/NCT05755113"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma","extremity-soft-tissue-sarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["qbiotics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05755113","phase":"2","setting":"A Phase IIa Open Label Study Evaluating the Preliminary Efficacy of Intratumoural Tigilanol Tiglate in Advanced and/or Metastatic Soft Tissue Sarcoma of the Extremities and Body Wall.","sponsor":"QBiotics Group Limited","started":"2023-04-13","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05608876","kind":"trial","name":"A Clinical Study to Investigate the Efficacy of Tigilanol Tiglate Directly in Head and Neck Cancer","aka":[],"tldr":"A phase 2 trial of Tigilanol Tiglate in head and neck squamous cell carcinoma, run by QBiotics Group Limited, active and no longer recruiting.","summary":"A Clinical Study to Investigate the Efficacy of Tigilanol Tiglate Directly in Head and Neck Cancer is a phase 2 interventional study registered as NCT05608876 by QBiotics Group Limited, with 15 participants enrolled, started 2022-11-03 and due to reach its primary completion in 2025-07-31. Interventions recorded: Tigilanol Tiglate.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05608876","url":"https://clinicaltrials.gov/study/NCT05608876"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["qbiotics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05608876","phase":"2","setting":"A Phase II, Open Label, Single Arm Study To Assess The Efficacy Of Intratumoral Tigilanol Tiglate In Various Head And Neck Solid Malignancies","sponsor":"QBiotics Group Limited","started":"2022-11-03","startedType":"actual","enrolled":15,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07079631","kind":"trial","name":"A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT3","aka":[],"tldr":"A phase 1/2 trial of PM8002, Bevacizumab in colorectal cancer, run by BioNTech SE, now recruiting.","summary":"A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer is a phase 1/2 interventional study registered as NCT07079631 by BioNTech SE, with 482 participants planned, started 2025-07-18 and due to reach its primary completion in 2030-12. Interventions recorded: BNT314, Pumitamig, SoC chemotherapy treatment 1, SoC chemotherapy treatment 2, Bevacizumab. Conditions listed: Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07079631","url":"https://clinicaltrials.gov/study/NCT07079631"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002","bevacizumab"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07079631","phase":"1/2","setting":"A Phase I/II, Randomized, Multi-site Trial to Investigate the Efficacy and Safety of BNT314 in Combination With Pumitamig and Chemotherapy in Participants With Metastatic Colorectal Cancer","sponsor":"BioNTech SE","started":"2025-07-18","startedType":"actual","enrolled":482,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07070232","kind":"trial","name":"A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors","aka":[],"tldr":"A phase 1/2 trial of PM8002 in advanced solid tumours, run by BioNTech SE, now recruiting.","summary":"A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors is a phase 1/2 interventional study registered as NCT07070232 by BioNTech SE, with 1438 participants planned, started 2025-08-12 and due to reach its primary completion in 2028-03. Interventions recorded: BNT326, Pumitamig, Itraconazole and Paroxetine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07070232","url":"https://clinicaltrials.gov/study/NCT07070232"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07070232","phase":"1/2","setting":"A Phase I/II, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies in Participants With Advanced Solid Tumors","sponsor":"BioNTech SE","started":"2025-08-12","startedType":"actual","enrolled":1438,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07113275","kind":"trial","name":"A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course R","aka":[],"tldr":"A phase 3 trial of capecitabine, fOLFOX (5-FU, leucovorin, oxaliplatin) and serplulimab in colorectal cancer, run by Tao Zhang, now recruiting.","summary":"A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT07113275 by Tao Zhang, with a registry enrolment figure of 444 participants, started 2026-05-15 and due to reach its primary completion in 2028-01-01. Interventions recorded: Short-course radiotherapy; Long-course radiotherapy; Capecitabine; Oxaliplatin; HLX10; TME surgery; HLX10 placebo. Conditions listed: Rectal Cancer; Total Neoadjuvant Therapy; Radiotherapy; Immunotherapy. Primary outcome: 3-year event-Free Survival. Colorectal eligibility wording from the registry: \"Histologically confirmed Locally Advanced rectal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07113275","url":"https://clinicaltrials.gov/study/NCT07113275"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capecitabine","folfox","serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07113275","phase":"3","setting":"A National Multicenter, Randomized, Placebo-Controlled Phase III Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer","sponsor":"Tao Zhang","started":"2026-05-15","startedType":"estimated","enrolled":444,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04183166","kind":"trial","name":"A Clinical Trial Evaluating TG4050 in Head and Neck Cancer","aka":[],"tldr":"A phase 1/2 trial of TG4050 in head and neck squamous cell carcinoma, run by Transgene, active and no longer recruiting.","summary":"A Clinical Trial Evaluating TG4050 in Head and Neck Cancer is a phase 1/2 interventional study registered as NCT04183166 by Transgene, with 80 participants enrolled, started 2019-12-12 and due to reach its primary completion in 2027-12-30. Interventions recorded: TG4050.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04183166","url":"https://clinicaltrials.gov/study/NCT04183166"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["transgene"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04183166","phase":"1/2","setting":"A Randomized Phase I/II Trial in Patients With Newly Diagnosed, Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Evaluating a Mutanome-directed Immunotherapy.","sponsor":"Transgene","started":"2019-12-12","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05890742","kind":"trial","name":"A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer","aka":[],"tldr":"A phase 3 trial of Sintilimab in colorectal cancer, run by Innovent Biologics (Suzhou) Co. Ltd., active and no longer recruiting.","summary":"A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer is a phase 3 interventional study registered as NCT05890742 by Innovent Biologics (Suzhou) Co. Ltd., with 453 participants enrolled, started 2023-05-25 and due to reach its primary completion in 2028-04-15. Interventions recorded: Sintilimab, IBI310&Sintilimab and Radical surgery.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05890742","url":"https://clinicaltrials.gov/study/NCT05890742"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["sintilimab"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05890742-cancer-cell-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05890742","phase":"3","setting":"A Phase 1b/3 Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","started":"2023-05-25","startedType":"actual","enrolled":453,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07258407","kind":"trial","name":"A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate Cancer","aka":[],"tldr":"A phase 1/2 trial of TD001 in prostate cancer, run by T.O.A.D. Oncology SA, now recruiting.","summary":"A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate Cancer is a phase 1/2 interventional study registered as NCT07258407 by T.O.A.D. Oncology SA, with 180 participants planned, started 2026-01-30 and due to reach its primary completion in 2028-03. Interventions recorded: TD001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07258407","url":"https://clinicaltrials.gov/study/NCT07258407"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["adc"],"targets":["psma"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07258407","phase":"1/2","setting":"A Phase 1/2 Dose Escalation Trial With Administration Schedule Exploration Evaluating Single Agent TD001, a PSMA-Targeted Antibody-Drug Conjugate, in Patients With PSMA-Expressing Metastatic Castration-Resistant Prostate Cancer","sponsor":"T.O.A.D. Oncology SA","started":"2026-01-30","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07653685","kind":"trial","name":"A Clinical Trial Evaluating TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Patients With HER2-Abnormally Expressed Unresectable Locally Advan","aka":[],"tldr":"A phase 1/2 trial of capecitabine and bevacizumab in colorectal cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., now recruiting.","summary":"A Clinical Trial Evaluating TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Patients With HER2-Abnormally Expressed Unresectable Locally Advanced or Metastatic Colorectal Cancer. is a phase 1/2, randomised interventional study registered as NCT07653685 by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., with a registry enrolment figure of 71 participants, started 2026-09-03 and due to reach its primary completion in 2027-06. Interventions recorded: TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)+Bevacizumab injection; TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets). Conditions listed: Colorectal Cancer. Primary outcome: Recommended Phase 2 Dose; Adverse event (AE); Objective Response Rate. Colorectal eligibility wording from the registry: \"* Unresectable locally advanced or metastatic colorectal cancer diagnosed by histopathology/cytology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07653685","url":"https://clinicaltrials.gov/study/NCT07653685"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","her2-amplified-colorectal"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["capecitabine","bevacizumab"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07653685","phase":"1/2","setting":"A Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Participants With HER2-Abnormally Expressed Unresectable Locally Advanced or Metastatic Colorectal Cancer.","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","started":"2026-09-03","startedType":"actual","enrolled":71,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04534205","kind":"trial","name":"A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1","aka":["AHEAD-MERIT"],"tldr":"A phase 2/3 trial testing BNT113 in head and neck squamous cell carcinoma, active and no longer recruiting.","summary":"A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 is a phase 2/3 interventional study registered as NCT04534205, led by BioNTech SE, and active but no longer recruiting on the registry. Official title: An Open-label Phase II/III Randomised Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1. Planned enrolment is 358 participants (actual). The study started in 2021-01-07 and primary completion is expected in 2028-08. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04534205","url":"https://clinicaltrials.gov/study/NCT04534205"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","hpv-positive-oropharyngeal-cancer","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["bnt113"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04534205","phase":"2/3","setting":"An Open-label Phase II/III Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1","sponsor":"BioNTech SE","started":"2021-01-07","startedType":"actual","enrolled":358,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07513376","kind":"trial","name":"A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I ","aka":["INTerpath-014"],"tldr":"A phase 3 trial of Intismeran autogene in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014) is a phase 3 interventional study registered as NCT07513376 by Merck Sharp & Dohme LLC, with 876 participants planned, started 2026-05-04 and due to reach its primary completion in 2034-08-22. Interventions recorded: Intismeran, Pembrolizumab coformulated with berahyaluronidase alfa, Placebo. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07513376","url":"https://clinicaltrials.gov/study/NCT07513376"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["neoantigen-mrna-vaccine"],"targets":[],"drugs":["intismeran-autogene"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07513376","phase":"3","setting":"A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)","sponsor":"Merck Sharp & Dohme LLC","started":"2026-05-04","startedType":"actual","enrolled":876,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07554339","kind":"trial","name":"A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)","aka":["KANDLELIT-015"],"tldr":"A phase 3 trial testing Calderasib in non-small-cell lung cancer, now recruiting.","summary":"A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015) is a phase 3 interventional study registered as NCT07554339, led by Merck Sharp & Dohme, and recruiting on the registry. Official title: A Phase 3, Randomised, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015). Planned enrolment is 310 participants (estimated). The study started in 2026-06-18 and primary completion is expected in 2032-12-15. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07554339","url":"https://clinicaltrials.gov/study/NCT07554339"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["calderasib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07554339","phase":"3","setting":"A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)","sponsor":"Merck Sharp & Dohme","started":"2026-06-18","startedType":"actual","enrolled":310,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03274414","kind":"trial","name":"A Clinical Trial of Endoscopic Surgery Followed by Chemotherapy and Proton Radiation for the Treatment of Tumors in the Sinus and Nasal Passages","aka":[],"tldr":"A phase 2 trial of Endoscopic resection in Nasal cavity and paranasal sinus cancers, run by Memorial Sloan Kettering Cancer Center, completed.","summary":"A Clinical Trial of Endoscopic Surgery Followed by Chemotherapy and Proton Radiation for the Treatment of Tumors in the Sinus and Nasal Passages is a phase 2 interventional study registered as NCT03274414 by Memorial Sloan Kettering Cancer Center, with 3 participants recorded, started 2017-09-01 and reaching its primary completion in 2023-01-13. Interventions recorded: Cisplatin, Adjuvant Proton Radiotherapy, Endoscopic Resection, cisplatin and etoposide. Conditions recorded: Paranasal Sinus Cancer, Nasal Cavity Tumor, Nasal Cavity Adenocarcinoma.\n\nLinked to the technology Endoscopic resection because the registry names it (\"endoscopic resection\") among its interventions and Nasal cavity and paranasal sinus cancers among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03274414","url":"https://clinicaltrials.gov/study/NCT03274414"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sinonasal"],"sections":[],"technologies":["endoscopic-resection"],"targets":[],"drugs":["cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03274414","phase":"2","setting":"A Phase II, Single-Arm Trial Assessing Local Control of Near Total Endoscopic Resection Followed by Concurrent Chemotherapy and Proton Radiation in the Treatment of Unresectable Sinonasal Tumors","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2017-09-01","startedType":"actual","enrolled":3,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07032077","kind":"trial","name":"A Clinical Trial of HRS-7058 Combined Anti-tumor Drugs in Subjects With Solid Tumors","aka":[],"tldr":"A phase 2 trial of HRS-7058 in advanced solid tumours, run by Shandong Suncadia Medicine Co., Ltd., now recruiting.","summary":"A Clinical Trial of HRS-7058 Combined Anti-tumor Drugs in Subjects With Solid Tumors is a phase 2 interventional study registered as NCT07032077 by Shandong Suncadia Medicine Co., Ltd., with 100 participants planned, started 2025-07-09 and due to reach its primary completion in 2027-06. Interventions recorded: HRS-7058.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07032077","url":"https://clinicaltrials.gov/study/NCT07032077"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07032077","phase":"2","setting":"A Phase II Clinical Trial on the Safety, Tolerability, and Efficacy of HRS-7058 Combined Anti-tumor Drugs in Subjects With Solid Tumors","sponsor":"Shandong Suncadia Medicine Co., Ltd.","started":"2025-07-09","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07405151","kind":"trial","name":"A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)","aka":["KEYMAKER-U06"],"tldr":"A phase 1/2 trial of I-DXd in oesophageal cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F) is a phase 1/2 interventional study registered as NCT07405151 by Merck Sharp & Dohme LLC, with 60 participants planned, started 2026-03-27 and due to reach its primary completion in 2027-06-12. Interventions recorded: I-DXd and Rescue Medication.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07405151","url":"https://clinicaltrials.gov/study/NCT07405151"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07405151","phase":"1/2","setting":"A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L/3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F","sponsor":"Merck Sharp & Dohme LLC","started":"2026-03-27","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06783647","kind":"trial","name":"A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 01(NSCLC)]","aka":[],"tldr":"A phase 2 trial of Docetaxel, Bevacizumab, Pemetrexed and Carboplatin in advanced solid tumours, run by Nanjing Leads Biolabs Co.,Ltd, now recruiting.","summary":"A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 01(NSCLC)] is a phase 2 interventional study registered as NCT06783647 by Nanjing Leads Biolabs Co.,Ltd, with 250 participants planned, started 2025-06-11 and due to reach its primary completion in 2026-12-24. Interventions recorded: LBL-024 for Injection, Docetaxel Injection, Bevacizumab Injection, Pemetrexed Disodium for Injection, Paclitaxel Injection and Carboplatin Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06783647","url":"https://clinicaltrials.gov/study/NCT06783647"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["docetaxel","bevacizumab","pemetrexed","carboplatin"],"companies":["nanjing-leads-biolabs"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06783647","phase":"2","setting":"An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour[Substudy Number 01(NSCLC)]","sponsor":"Nanjing Leads Biolabs Co.,Ltd","started":"2025-06-11","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07111546","kind":"trial","name":"A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 02(BTC&HCC)]","aka":[],"tldr":"A phase 2 trial of Cisplatin, Gemcitabine and Bevacizumab in advanced solid tumours, run by Nanjing Leads Biolabs Co.,Ltd, now recruiting.","summary":"A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 02(BTC&HCC)] is a phase 2 interventional study registered as NCT07111546 by Nanjing Leads Biolabs Co.,Ltd, with 140 participants planned, started 2025-10-20 and due to reach its primary completion in 2027-12-26. Interventions recorded: LBL-024 for Injection, Cisplatin Injection, Gemcitabine Hydrochloride for Injection and Bevacizumab Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07111546","url":"https://clinicaltrials.gov/study/NCT07111546"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cisplatin","gemcitabine","bevacizumab"],"companies":["nanjing-leads-biolabs"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07111546","phase":"2","setting":"An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour[Substudy Number 02(BTC&HCC)]","sponsor":"Nanjing Leads Biolabs Co.,Ltd","started":"2025-10-20","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07791758","kind":"trial","name":"A Clinical Trial of LBL-024 Combination Drug in Patients With Metastatic Colorectal Carcinoma","aka":[],"tldr":"A phase 1/2 trial of bevacizumab, oxaliplatin and capecitabine in colorectal cancer, run by Nanjing Leads Biolabs Co.,Ltd, not yet recruiting.","summary":"A Clinical Trial of LBL-024 Combination Drug in Patients With Metastatic Colorectal Carcinoma is a phase 1/2, randomised interventional study registered as NCT07791758 by Nanjing Leads Biolabs Co.,Ltd, with a registry enrolment figure of 369 participants, started 2026-09-04 and due to reach its primary completion in 2030-09-04. Interventions recorded: LBL-024 for Injection; Bevacizumab injection; Oxaliplatin injection; Capecitabine tablets; Fruquintinib Capsules. Conditions listed: Metastatic Colorectal Carcinoma. Primary outcome: Objective Response Rate (ORR); Occurrence of adverse event (AE) and serious adverse event (SAE). Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07791758","url":"https://clinicaltrials.gov/study/NCT07791758"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["bevacizumab","oxaliplatin","capecitabine"],"companies":["nanjing-leads-biolabs"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07791758","phase":"1/2","setting":"An Open-label, Multicenter Phase Ib/II Study to Evaluate the Safety and Efficacy of LBL-024 Combination Therapy in Patients With Metastatic Colorectal Carcinoma","sponsor":"Nanjing Leads Biolabs Co.,Ltd","started":"2026-09-04","startedType":"estimated","enrolled":369,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06049290","kind":"trial","name":"A Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma","aka":[],"tldr":"A phase 1/2 trial of LBL-034 for Injection in multiple myeloma, run by Nanjing Leads Biolabs Co.,Ltd, now recruiting.","summary":"A Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT06049290 by Nanjing Leads Biolabs Co.,Ltd, with 342 participants planned, started 2023-10-20 and due to reach its primary completion in 2026-10-20. Interventions recorded: LBL-034 for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06049290","url":"https://clinicaltrials.gov/study/NCT06049290"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["nanjing-leads-biolabs"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06049290","phase":"1/2","setting":"A Multicenter, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-034 in Patients With Relapsed/Refractory Multiple Myeloma","sponsor":"Nanjing Leads Biolabs Co.,Ltd","started":"2023-10-20","startedType":"actual","enrolled":342,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07634471","kind":"trial","name":"A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)","aka":[],"tldr":"A phase 2/3 trial testing MK-1045 in follicular lymphoma, now recruiting.","summary":"A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007) is a phase 2/3 interventional study registered as NCT07634471, led by Merck Sharp & Dohme, and recruiting on the registry. Official title: A Phase 2/3 Randomised, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma. Planned enrolment is 960 participants (estimated). The study started in 2026-06-22 and primary completion is expected in 2032-07-23. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07634471","url":"https://clinicaltrials.gov/study/NCT07634471"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["mk-1045"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07634471","phase":"2/3","setting":"A Phase 2/3 Randomized, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma","sponsor":"Merck Sharp & Dohme","started":"2026-06-22","startedType":"actual","enrolled":960,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07570173","kind":"trial","name":"A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)","aka":[],"tldr":"A phase 2/3 trial testing MK-1045 in acute lymphoblastic leukaemia, now recruiting.","summary":"A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukaemia (MK-1045-005) is a phase 2/3 interventional study registered as NCT07570173, led by Merck Sharp & Dohme, and recruiting on the registry. Official title: A Phase 2/3, Randomised, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukaemia (B-ALL). Planned enrolment is 340 participants (estimated). The study started in 2026-05-18 and primary completion is expected in 2033-10-18. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07570173","url":"https://clinicaltrials.gov/study/NCT07570173"}],"tags":["ctgov-ingest"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":[],"targets":[],"drugs":["mk-1045","siltuximab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07570173","phase":"2/3","setting":"A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)","sponsor":"Merck Sharp & Dohme","started":"2026-05-18","startedType":"actual","enrolled":340,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07318558","kind":"trial","name":"A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)","aka":["TroFuse-021"],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Bevacizumab in ovarian cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) is a phase 3 interventional study registered as NCT07318558 by Merck Sharp & Dohme LLC, with 900 participants planned, started 2026-02-16 and due to reach its primary completion in 2033-02-25. Interventions recorded: Sacituzumab tirumotecan, Bevacizumab, Rescue Medications. Conditions listed: Ovarian Neoplasms, Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07318558","url":"https://clinicaltrials.gov/study/NCT07318558"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["adc","antiangiogenic","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","bevacizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07318558","phase":"3","setting":"A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)","sponsor":"Merck Sharp & Dohme LLC","started":"2026-02-16","startedType":"actual","enrolled":900,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07419295","kind":"trial","name":"A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)","aka":["TroFuse-031"],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Vinflunine and Docetaxel in bladder & urothelial cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031) is a phase 3 interventional study registered as NCT07419295 by Merck Sharp & Dohme LLC, with 590 participants planned, started 2026-04-23 and due to reach its primary completion in 2029-07-27. Interventions recorded: Sacituzumab tirumotecan, Vinflunine, Docetaxel, Paclitaxel, Rescue medications for sacituzumab tirumotecan and Rescue medications for chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07419295","url":"https://clinicaltrials.gov/study/NCT07419295"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","vinflunine","docetaxel"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07419295","phase":"3","setting":"A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator's Choice of Non-platinum Chemotherapy in Participants With Pretreated Locally Advanced/Metastatic Urothelial Carcinoma","sponsor":"Merck Sharp & Dohme LLC","started":"2026-04-23","startedType":"actual","enrolled":590,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07111832","kind":"trial","name":"A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer","aka":[],"tldr":"A phase 3 trial of Trastuzumab rezetecan, Adebrelimab and Toripalimab in triple-negative breast cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer is a phase 3 interventional study registered as NCT07111832 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 400 participants planned, started 2025-08-20 and due to reach its primary completion in 2028-03. Interventions recorded: SHR-A1811 for Injection, SHR-1316 Injection, Toripalimab Injection and Paclitaxel for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07111832","url":"https://clinicaltrials.gov/study/NCT07111832"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["adc","checkpoint-inhibitor","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","adebrelimab","toripalimab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07111832","phase":"3","setting":"A Phase III, Multicenter, Randomized, Open-label, Active-controlled Study of SHR-A1811 Plus SHR-1316 Versus Toripalimab Plus Nab-paclitaxel in PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-08-20","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04657991","kind":"trial","name":"A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma","aka":[],"tldr":"A phase 3 trial of Encorafenib, Binimetinib, Pembrolizumab in melanoma, run by Pfizer, active and no longer recruiting.","summary":"A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma is a phase 3 interventional study registered as NCT04657991 by Pfizer, with 257 participants enrolled, started 2021-01-15 and due to reach its primary completion in 2026-10-30. Interventions recorded: Encorafenib, Binimetinib, Pembrolizumab. Conditions listed: Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04657991","url":"https://clinicaltrials.gov/study/NCT04657991"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma","braf-v600-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["encorafenib","binimetinib","pembrolizumab"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04657991-eur-j-cancer-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04657991","phase":"3","setting":"A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF ENCORAFENIB AND BINIMETINIB PLUS PEMBROLIZUMAB VERSUS PLACEBO PLUS PEMBROLIZUMAB IN PARTICIPANTS WITH BRAF V600E/K MUTATION-POSITIVE METASTATIC OR UNRESECTABLE LOCALLY ADVANCED MELANOMA","sponsor":"Pfizer","started":"2021-01-15","startedType":"actual","enrolled":257,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06496490","kind":"trial","name":"A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality","aka":[],"tldr":"A phase 2 trial of TQB2102 in non-small-cell lung cancer and small-cell lung cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., now recruiting.","summary":"A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality is a phase 2 interventional study registered as NCT06496490 by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., with 270 participants planned, started 2024-08-06 and due to reach its primary completion in 2026-06. Interventions recorded: TQB2102 for injection, TQB2102 for injection combined with Benmelstobart injection. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06496490","url":"https://clinicaltrials.gov/study/NCT06496490"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","her2-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb2102"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06496490","phase":"2","setting":"A Phase 2 Clinical Trial of TQB2102 for Injection in Locally Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Gene Abnormality to Evaluate the Efficacy and Safety","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","started":"2024-08-06","startedType":"actual","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06561607","kind":"trial","name":"A Clinical Trial of TQB2102 for Injection in the Treatment of HER2 Low-Expressing Recurrent/Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial testing TQB2102 in HR-positive / HER2-negative breast cancer, active and no longer recruiting.","summary":"A Clinical Trial of TQB2102 for Injection in the Treatment of HER2 Low-Expressing Recurrent/Metastatic Breast Cancer is a phase 3 interventional study registered as NCT06561607, led by Chia Tai Tianqing Pharmaceutical, and active but no longer recruiting on the registry. Official title: A Randomised, Open, Parallel-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of TQB2102 for Injection Versus Investigator-Selected Chemotherapy in HER2 Low-Expressing Recurrent/Metastatic Breast Cancer. Planned enrolment is 542 participants (estimated). The study started in 2024-10-11 and primary completion is expected in 2027-01. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06561607","url":"https://clinicaltrials.gov/study/NCT06561607"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","her2-low-metastatic-breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb2102"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06561607","phase":"3","setting":"A Randomized, Open, Parallel-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of TQB2102 for Injection Versus Investigator-Selected Chemotherapy in HER2 Low-Expressing Recurrent/Metastatic Breast Cancer","sponsor":"Chia Tai Tianqing Pharmaceutical","started":"2024-10-11","startedType":"actual","enrolled":542,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07011186","kind":"trial","name":"A Clinical Trial of TQB3909 Tablets in Combination With Azacitidine for the Treatment of Myeloid Malignancies","aka":[],"tldr":"A phase 1/2 trial of Azacitidine in advanced solid tumours, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., now recruiting.","summary":"A Clinical Trial of TQB3909 Tablets in Combination With Azacitidine for the Treatment of Myeloid Malignancies is a phase 1/2 interventional study registered as NCT07011186 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with 138 participants planned, started 2024-04-17 and due to reach its primary completion in 2025-10. Interventions recorded: TQB3909 Tablets + Azacitidine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07011186","url":"https://clinicaltrials.gov/study/NCT07011186"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["azacitidine","tqb3909"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07011186","phase":"1/2","setting":"A Phase Ib/II Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of TQB3909 Tablets in Combination With Azacitidine in Subjects With Myeloid Malignancies","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2024-04-17","startedType":"actual","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07367529","kind":"trial","name":"A Clinical Trial on the Efficacy and Safety of TQB6411 for Injection","aka":[],"tldr":"A phase 1/2 trial of TQB6411 in advanced solid tumours, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., now recruiting.","summary":"A Clinical Trial on the Efficacy and Safety of TQB6411 for Injection is a phase 1/2 interventional study registered as NCT07367529 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with 465 participants planned, started 2026-02-26 and due to reach its primary completion in 2028-12. Interventions recorded: TQB6411 for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07367529","url":"https://clinicaltrials.gov/study/NCT07367529"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb6411"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07367529","phase":"1/2","setting":"A Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of TQB6411 for Injection in Patients With Advanced Lung Cancer","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2026-02-26","startedType":"actual","enrolled":465,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07255404","kind":"trial","name":"A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have N","aka":[],"tldr":"A phase 2 trial of PM8002, Paclitaxel / nab-paclitaxel, Gemcitabine in pancreatic ductal adenocarcinoma, run by BioNTech SE, now recruiting.","summary":"A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer is a phase 2 interventional study registered as NCT07255404 by BioNTech SE, with 105 participants planned, started 2025-12-04 and due to reach its primary completion in 2027-12. Interventions recorded: Pumitamig, Nab-paclitaxel, Gemcitabine, mFOLFIRINOX. Conditions listed: Pancreatic Ductal Adenocarcinoma (PDAC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07255404","url":"https://clinicaltrials.gov/study/NCT07255404"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002","paclitaxel","gemcitabine","folfirinox"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07255404","phase":"2","setting":"A Phase II, Multi-site, Randomized, Open-label, Trial of Pumitamig in Combination With Chemotherapy in Patients With Metastatic Pancreatic Cancer","sponsor":"BioNTech SE","started":"2025-12-04","startedType":"actual","enrolled":105,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07297212","kind":"trial","name":"A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma","aka":[],"tldr":"A phase 2 trial of PM8002, Bevacizumab and Temozolomide in glioma & glioblastoma, run by BioNTech SE, now recruiting.","summary":"A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma is a phase 2 interventional study registered as NCT07297212 by BioNTech SE, with 75 participants planned, started 2026-01-15 and due to reach its primary completion in 2028-01. Interventions recorded: Pumitamig, Bevacizumab and Temozolomide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07297212","url":"https://clinicaltrials.gov/study/NCT07297212"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["pm8002","bevacizumab","temozolomide"],"companies":["biontech","bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07297212","phase":"2","setting":"A Phase II, Multi-site, Open-label Trial Evaluating the Safety and Efficacy of Pumitamig and Bevacizumab as Monotherapy and Pumitamig in Combination With Temozolomide in Patients With Recurrent Glioblastoma","sponsor":"BioNTech SE","started":"2026-01-15","startedType":"actual","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07049055","kind":"trial","name":"A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer","aka":["Carolyn-USA"],"tldr":"A phase 1/2 trial of E-EDV-D682, Gemcitabine, Paclitaxel / nab-paclitaxel in pancreatic ductal adenocarcinoma, run by Engeneic Pty Limited, now recruiting.","summary":"A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer is a phase 1/2 interventional study registered as NCT07049055 by Engeneic Pty Limited, with 144 participants planned, started 2026-01-12 and due to reach its primary completion in 2028-09. Interventions recorded: E-EDV-D682, EDV-GC, Gemcitabine, Nab paclitaxel.. Conditions listed: Pancreatic Cancer, Metastatic, PDAC - Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07049055","url":"https://clinicaltrials.gov/study/NCT07049055"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["e-edv-d682","gemcitabine","paclitaxel"],"companies":["engeneic"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07049055","phase":"1/2","setting":"A Phase I/IIa Randomized Clinical Trial to Evaluate the Efficacy of EGFR-targeted, PNU-159682-packaged Nanocells & Glycolipid-Packaged Nanocells in Combination With Gemcitabine & Nab-paclitaxel in Metastatic Pancreatic Ductal Adenocarcinoma","sponsor":"Engeneic Pty Limited","started":"2026-01-12","startedType":"actual","enrolled":144,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06223841","kind":"trial","name":"A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors","aka":[],"tldr":"A phase 1/2 trial of IAP0971 in advanced solid tumours, run by SUNHO（China）BioPharmaceutical CO., Ltd., now recruiting.","summary":"A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors is a phase 1/2 interventional study registered as NCT06223841 by SUNHO（China）BioPharmaceutical CO., Ltd., with 50 participants planned, started 2024-03-01 and due to reach its primary completion in 2026-03-01. Interventions recorded: IAP0971.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06223841","url":"https://clinicaltrials.gov/study/NCT06223841"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sunho-biopharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06223841","phase":"1/2","setting":"A Clinical Trial of Phase Ib/II to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors","sponsor":"SUNHO（China）BioPharmaceutical CO., Ltd.","started":"2024-03-01","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06581419","kind":"trial","name":"A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors","aka":[],"tldr":"A phase 1/2 trial of IAP0971 in non-small-cell lung cancer, run by SUNHO（China）BioPharmaceutical CO., Ltd., now recruiting.","summary":"A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors is a phase 1/2 interventional study registered as NCT06581419 by SUNHO（China）BioPharmaceutical CO., Ltd., with 78 participants planned, started 2024-12-31 and due to reach its primary completion in 2029-08-01. Interventions recorded: IAP0971.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06581419","url":"https://clinicaltrials.gov/study/NCT06581419"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sunho-biopharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06581419","phase":"1/2","setting":"A Phase I/II Clinical Study Evaluating Safety, Tolerability, and Efficacy of IAP0971 in Advanced Tumors","sponsor":"SUNHO（China）BioPharmaceutical CO., Ltd.","started":"2024-12-31","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05991583","kind":"trial","name":"A Clinical Trial to Evaluate Effect of IBB0979 in Patients With Advanced Malignant Tumors","aka":[],"tldr":"A phase 1/2 trial of IBB0979 in advanced solid tumours, run by SUNHO（China）BioPharmaceutical CO., Ltd., now recruiting.","summary":"A Clinical Trial to Evaluate Effect of IBB0979 in Patients With Advanced Malignant Tumors is a phase 1/2 interventional study registered as NCT05991583 by SUNHO（China）BioPharmaceutical CO., Ltd., with 25 participants planned, started 2023-07-03 and due to reach its primary completion in 2025-11-30. Interventions recorded: IBB0979.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05991583","url":"https://clinicaltrials.gov/study/NCT05991583"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sunho-biopharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05991583","phase":"1/2","setting":"A Phase I/II Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBB0979 in Patients With Locally Advanced or Metastatic Solid Tumors","sponsor":"SUNHO（China）BioPharmaceutical CO., Ltd.","started":"2023-07-03","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06292208","kind":"trial","name":"A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors","aka":[],"tldr":"A phase 1/2 trial of IBD0333 in advanced solid tumours, run by SUNHO（China）BioPharmaceutical CO., Ltd., now recruiting.","summary":"A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors is a phase 1/2 interventional study registered as NCT06292208 by SUNHO（China）BioPharmaceutical CO., Ltd., with 48 participants planned, started 2024-03-09 and due to reach its primary completion in 2029-12-31. Interventions recorded: IBD0333.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06292208","url":"https://clinicaltrials.gov/study/NCT06292208"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sunho-biopharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06292208","phase":"1/2","setting":"Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) and Preliminary Efficacy of IBD0333 in Patients With Locally Advanced/Metastatic Solid Tumor or Non-Hodgkin Lymphoma","sponsor":"SUNHO（China）BioPharmaceutical CO., Ltd.","started":"2024-03-09","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07582432","kind":"trial","name":"A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma","aka":["SIGMA"],"tldr":"A phase 3 trial of Gamunex-C, 10% Injectable Solution in non-Hodgkin lymphoma, run by Grifols Biologicals, LLC, now recruiting.","summary":"A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma is a phase 3 interventional study registered as NCT07582432 by Grifols Biologicals, LLC, with 49 participants planned, started 2026-04-23 and due to reach its primary completion in 2028-08-31. Interventions recorded: Gamunex-C, 10% Injectable Solution.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07582432","url":"https://clinicaltrials.gov/study/NCT07582432"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["grifols"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07582432","phase":"3","setting":"An Open-label, Multi-Center, Single-arm Prospective Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex®-C Plus Standard Medical Treatment to Prevent Infections in Participants With Secondary Antibody Deficiency Associated With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma","sponsor":"Grifols Biologicals, LLC","started":"2026-04-23","startedType":"estimated","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06888921","kind":"trial","name":"A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer","aka":[],"tldr":"A phase 1/2 trial of COM701 in ovarian cancer, run by Compugen Ltd, now recruiting.","summary":"A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer is a phase 1/2 interventional study registered as NCT06888921 by Compugen Ltd, with 60 participants planned, started 2025-07-21 and due to reach its primary completion in 2027-03. Interventions recorded: COM701 and Normal Saline.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06888921","url":"https://clinicaltrials.gov/study/NCT06888921"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06888921","phase":"1/2","setting":"An Adaptive Clinical Platform Trial to Evaluate the Safety and Efficacy of COM701 as Monotherapy or Combination Therapy as Maintenance Therapy in Participants With Relapsed Platinum Sensitive Ovarian Cancer (PSOC)","sponsor":"Compugen Ltd","started":"2025-07-21","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07111520","kind":"trial","name":"A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced ","aka":[],"tldr":"A phase 1/2 trial of PM8002 in non-small-cell lung cancer and small-cell lung cancer, run by BioNTech SE, now recruiting.","summary":"A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) is a phase 1/2 interventional study registered as NCT07111520 by BioNTech SE, with 880 participants planned, started 2025-09-22 and due to reach its primary completion in 2028-11. Interventions recorded: BNT326, Pumitamig. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07111520","url":"https://clinicaltrials.gov/study/NCT07111520"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07111520","phase":"1/2","setting":"A Phase Ib/II, Multi-site, Open-label, Dose Finding Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT326 in Combination With BNT327 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)","sponsor":"BioNTech SE","started":"2025-09-22","startedType":"actual","enrolled":880,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07186842","kind":"trial","name":"A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9","aka":[],"tldr":"A phase 1/2 trial of BNT329 in advanced solid tumours, run by BioNTech SE, now recruiting.","summary":"A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9 is a phase 1/2 interventional study registered as NCT07186842 by BioNTech SE, with 245 participants planned, started 2025-11-18 and due to reach its primary completion in 2030-05. Interventions recorded: BNT329 and CA19-9-targeting monoclonal antibody.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07186842","url":"https://clinicaltrials.gov/study/NCT07186842"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07186842","phase":"1/2","setting":"First-in-human, Open-label, Multi-site, Phase I/IIa, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT329 in Participants With Advanced Solid Tumors Known to Express CA19-9","sponsor":"BioNTech SE","started":"2025-11-18","startedType":"actual","enrolled":245,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04529772","kind":"trial","name":"A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)","aka":["ACE-LY-312"],"tldr":"A phase 3 trial of Acalabrutinib, Prednisone, Rituximab in diffuse large b-cell lymphoma, run by Acerta Pharma BV, active and no longer recruiting.","summary":"A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) is a phase 3 interventional study registered as NCT04529772 by Acerta Pharma BV, with 611 participants enrolled, started 2020-10-08 and due to reach its primary completion in 2027-02-22. Interventions recorded: acalabrutinib, placebo, Prednisone, Rituximab, Cyclophosphamide. Conditions listed: Diffuse Large B-Cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04529772","url":"https://clinicaltrials.gov/study/NCT04529772"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["acalabrutinib","prednisone","rituximab","cyclophosphamide","vincristine","doxorubicin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04529772","phase":"3","setting":"Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL","sponsor":"Acerta Pharma BV","started":"2020-10-08","startedType":"actual","enrolled":611,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06835530","kind":"trial","name":"A Combination of Rituximab and CC-99282 as Front-line Therapy for Older Frail Patients With Diffuse Large B-cells Non-Hodgkin Lymphoma Evaluated With a Simplified Geriatric Assessment (sGA): a Phase II Study of the Fondazione Italiana Linfomi (FIL)","aka":[],"tldr":"A phase 2 trial of Geriatric assessment in Non-Hodgkin lymphoma, run by Fondazione Italiana Linfomi - ETS, now recruiting.","summary":"A Combination of Rituximab and CC-99282 as Front-line Therapy for Older Frail Patients With Diffuse Large B-cells Non-Hodgkin Lymphoma Evaluated With a Simplified Geriatric Assessment (sGA): a Phase II Study of the Fondazione Italiana Linfomi (FIL) is a phase 2 interventional study registered as NCT06835530 by Fondazione Italiana Linfomi - ETS, with 47 participants planned, started 2025-04-09 and due to reach its primary completion in 2030-04. Interventions recorded: Rituximab + Golcadomide (CC-99282). Conditions recorded: Diffuse Large B Cell Non-Hodgkin Lymphoma.\n\nLinked to the technology Geriatric assessment because the registry's title names it (\"geriatric assessment\") and Non-Hodgkin lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06835530","url":"https://clinicaltrials.gov/study/NCT06835530"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","dlbcl"],"sections":[],"technologies":["geriatric-assessment"],"targets":[],"drugs":["golcadomide"],"companies":["fondazione-italiana-linfomi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06835530","phase":"2","setting":"A Combination of Rituximab and CC-99282 as Front-line Therapy for Older Frail Patients With Diffuse Large B-cells Non-Hodgkin Lymphoma Evaluated With a Simplified Geriatric Assessment (sGA): a Phase II Study of the Fondazione Italiana Linfomi (FIL)","sponsor":"Fondazione Italiana Linfomi - ETS","started":"2025-04-09","startedType":"actual","enrolled":47,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05359393","kind":"trial","name":"A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis","aka":["Miracle-1"],"tldr":"A phase 2 trial in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis is a phase 2, interventional study registered as NCT05359393 by Fudan University, with a registry enrolment figure of 52 participants, started 2022-12-01 and due to reach its primary completion in 2027-09-01. Interventions recorded: a combination therapy including tislelizumab. Conditions listed: Advanced Rectal Cancer; Liver Metastasis; Pulmonary Metastasis; Microsatellite Stable Colorectal Carcinoma. Primary outcome: NED rate. Colorectal eligibility wording from the registry: \"* Initial colonoscopy and pathology: adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05359393","url":"https://clinicaltrials.gov/study/NCT05359393"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05359393","phase":"2","setting":"Radiotherapy Followed by Chemotherapy and Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Liver/ Pulmonary Metastasis(Miracle-1): A Prospective, Single Arm, Multi-Center, Phase II Clinical Trial","sponsor":"Fudan University","started":"2022-12-01","startedType":"estimated","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07553988","kind":"trial","name":"A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer","aka":[],"tldr":"A phase 2 trial of Abiraterone acetate, Prednisone in prostate cancer, run by R-Pharm International, LLC, active and no longer recruiting.","summary":"A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer is a phase 2 interventional study registered as NCT07553988 by R-Pharm International, LLC, with 120 participants planned, started 2024-10-24 and due to reach its primary completion in 2026-05-14. Interventions recorded: RS-113, 160 mg, RS-113, 240 mg, RS-113, 320 mg, Abiraterone, Prednisolone. Conditions listed: Metastatic Castration-resistant Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07553988","url":"https://clinicaltrials.gov/study/NCT07553988"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["abiraterone","prednisone"],"companies":["r-pharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07553988","phase":"2","setting":"A Phase II, Open-label, Randomized, Comparative Dose-finding Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer","sponsor":"R-Pharm International, LLC","started":"2024-10-24","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04711252","kind":"trial","name":"A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease","aka":["SERENA-4"],"tldr":"A phase 3 trial of Camizestrant and Palbociclib in HR-positive / HER2-negative breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease is a phase 3 interventional study registered as NCT04711252 by AstraZeneca, with 1370 participants enrolled, started 2021-01-28 and due to reach its primary completion in 2026-08-24. Interventions recorded: AZD9833, Anastrozole, Anastrozole placebo, AZD9833 placebo, Palbociclib and Luteinizing hormone-releasing hormone (LHRH) agonist.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04711252","url":"https://clinicaltrials.gov/study/NCT04711252"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy"],"targets":[],"drugs":["camizestrant","palbociclib","anastrozole"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04711252","phase":"3","setting":"SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) Plus Palbociclib Versus Anastrozole Plus Palbociclib for the Treatment of Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease","sponsor":"AstraZeneca","started":"2021-01-28","startedType":"actual","enrolled":1370,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03602859","kind":"trial","name":"A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer","aka":[],"tldr":"A phase 3 trial of Niraparib and Dostarlimab in ovarian cancer, run by Tesaro, Inc., active and no longer recruiting.","summary":"A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer is a phase 3 interventional study registered as NCT03602859 by Tesaro, Inc., with 1400 participants enrolled, started 2018-10-11 and due to reach its primary completion in 2024-10-31. Interventions recorded: Niraparib, Dostarlimab (TSR-042), Standard of care, Dostarlimab-Placebo and Niraparib-Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03602859","url":"https://clinicaltrials.gov/study/NCT03602859"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["niraparib","dostarlimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03602859","phase":"3","setting":"A Randomized, Double-blind, Phase 3 Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer","sponsor":"Tesaro, Inc.","started":"2018-10-11","startedType":"actual","yearReported":2025,"enrolled":1400,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)","n":385,"value":19.19,"note":"95% CI 16.59 to 20.99; Figures from the ClinicalTrials.gov results section (first posted 2025-12-31), not from a publication"},{"name":"Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)","n":753,"value":20.63,"note":"95% CI 19.22 to 22.77"}],"hr":0.85,"ci":[0.73,0.99],"p":"0.0351","source":"https://clinicaltrials.gov/study/NCT03602859?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)","n":385,"value":45.37,"note":"95% CI 40.28 to 52.21; Figures from the ClinicalTrials.gov results section (first posted 2025-12-31), not from a publication"},{"name":"Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)","n":753,"value":44.39,"note":"95% CI 41.17 to 47.54"}],"source":"https://clinicaltrials.gov/study/NCT03602859?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)","n":385,"value":88,"note":"95% CI 83.7 to 91.6; Figures from the ClinicalTrials.gov results section (first posted 2025-12-31), not from a publication"},{"name":"Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)","n":753,"value":88.4,"note":"95% CI 85.5 to 90.9"}],"source":"https://clinicaltrials.gov/study/NCT03602859?tab=results"}]},{"id":"nct05989542","kind":"trial","name":"A Confirmatory Clinical Study in NSCLC Patients With MET Exon 14 Mutation (KUNPENG-2)","aka":["KUNPENG-2"],"tldr":"A phase 3 trial of Vebreltinib run by Beijing Pearl Biotechnology Limited Liability Company in non-small-cell lung cancer and small-cell lung cancer, now recruiting.","summary":"A Confirmatory Clinical Study in NSCLC Patients With MET Exon 14 Mutation (KUNPENG-2) is a phase 3 interventional study registered as NCT05989542 by Beijing Pearl Biotechnology Limited Liability Company, with 136 participants planned, started 2023-10-16. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05989542","url":"https://clinicaltrials.gov/study/NCT05989542"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["vebreltinib"],"companies":["beijing-pearl-biotechnology-limited-liability-company"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05989542","phase":"3","setting":"An Open, Multi-center, Single-arm Phase IIIb Confirmatory Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Vebreltinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With MET Exon 14 Mutation","sponsor":"Beijing Pearl Biotechnology Limited Liability Company","started":"2023-10-16","startedType":"actual","enrolled":136,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06184035","kind":"trial","name":"A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer","aka":[],"tldr":"A phase 1/2 trial of [177Lu]Lu-SN201 in advanced solid tumours, run by Spago Nanomedical AB, now recruiting.","summary":"A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer is a phase 1/2 interventional study registered as NCT06184035 by Spago Nanomedical AB, with 90 participants planned, started 2023-12-06 and due to reach its primary completion in 2027-12-01. Interventions recorded: [177Lu]Lu-SN201.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06184035","url":"https://clinicaltrials.gov/study/NCT06184035"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["lu177-radioligand-therapy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06184035","phase":"1/2","setting":"Ph I/IIa Escalation/Expansion FIH, Open, Multi Center, Single Arm Study Evaluating Safety, Dosimetry and Early Efficacy of 177Lu-SN201 in Progressive/Treatment-refractory, Locally Advanced, Unresectable Metastatic or Recurrent Solid Tumors","sponsor":"Spago Nanomedical AB","started":"2023-12-06","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03075696","kind":"trial","name":"A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treat","aka":[],"tldr":"A phase 1/2 trial of Glofitamab, Obinutuzumab, Tocilizumab in non-hodgkin lymphoma, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma is a phase 1/2 interventional study registered as NCT03075696 by Hoffmann-La Roche, with 940 participants planned, started 2017-02-21 and due to reach its primary completion in 2029-03-30. Interventions recorded: Glofitamab, Obinutuzumab, Tocilizumab. Conditions listed: Non-Hodgkin's Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03075696","url":"https://clinicaltrials.gov/study/NCT03075696"}],"tags":["ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":["monoclonal-antibody","t-cell-engager"],"targets":[],"drugs":["glofitamab","obinutuzumab","tocilizumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03075696","phase":"1/2","setting":"A Multicenter, Open-label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma","sponsor":"Hoffmann-La Roche","started":"2017-02-21","startedType":"actual","enrolled":940,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04333706","kind":"trial","name":"A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of S","aka":["EMPOWER"],"tldr":"A phase 1/2 trial of capecitabine in triple-negative breast cancer, run by University of Southern California, now recruiting.","summary":"A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER) is a phase 1/2, interventional study registered as NCT04333706 by University of Southern California, with a registry enrolment figure of 65 participants, started 2020-09-26 and due to reach its primary completion in 2026-11-03. Interventions recorded: Capecitabine; Sarilumab 150mg or 200 mg plus Capecitabine; Sarilumab 150mg plus Capecitabine. Conditions listed: Breast; Metastatic; Triple Negative; Cancer; Disseminated Tumor Cell. Triple-negative eligibility wording from the registry: \"A clinical diagnosis of metastatic triple negative or hormone resistant, Her2/neu-negative breast cancer that has been confirmed histologically at one point during the course of the disease\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04333706","url":"https://clinicaltrials.gov/study/NCT04333706"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04333706","phase":"1/2","setting":"A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER)","sponsor":"University of Southern California","started":"2020-09-26","startedType":"actual","enrolled":65,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07692204","kind":"trial","name":"A Dose Optimization/Expansion Study of SAR445877 in Adult Chinese Participants With Advanced Gastric or Gastroesophageal Junction Cancer","aka":[],"tldr":"A phase 2 trial of SAR445877 in gastric & gastro-oesophageal junction cancer and oesophageal cancer, run by Sanofi, now recruiting.","summary":"A Dose Optimization/Expansion Study of SAR445877 in Adult Chinese Participants With Advanced Gastric or Gastroesophageal Junction Cancer is a phase 2 interventional study registered as NCT07692204 by Sanofi, with 30 participants planned, started 2026-07-01 and due to reach its primary completion in 2028-08-02. Interventions recorded: SAR445877.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07692204","url":"https://clinicaltrials.gov/study/NCT07692204"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","esophageal","oesophageal-adenocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07692204","phase":"2","setting":"A Phase 2, Open-label, Dose Optimization/Expansion Study of SAR445877 Administered as Monotherapy or in Combination With Other Anticancer Therapies in Adults With Advanced Gastric or Gastroesophageal Junction Cancer","sponsor":"Sanofi","started":"2026-07-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07231068","kind":"trial","name":"A Dose-escalation and Dose-expansion Phase I/Phase II Clinical Study of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutation","aka":[],"tldr":"A phase 1/2 trial of Dositinib mesylate tablets in non-small-cell lung cancer, run by Henan Genuine Biotech Co., Ltd., now recruiting.","summary":"A Dose-escalation and Dose-expansion Phase I/Phase II Clinical Study of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutation is a phase 1/2 interventional study registered as NCT07231068 by Henan Genuine Biotech Co., Ltd., with 153 participants planned, started 2022-10-31 and due to reach its primary completion in 2027-12-31. Interventions recorded: Dositinib mesylate tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07231068","url":"https://clinicaltrials.gov/study/NCT07231068"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["henan-genuine-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07231068","phase":"1/2","setting":"A Dose-escalation and Dose-expansion Phase I/Phase II Clinical Study on the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutations","sponsor":"Henan Genuine Biotech Co., Ltd.","started":"2022-10-31","startedType":"actual","enrolled":153,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05006716","kind":"trial","name":"A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies","aka":["CaDAnCe-101"],"tldr":"A phase 1/2 trial of BGB-16673 in follicular lymphoma and hodgkin lymphoma, run by BeOne Medicines, now recruiting.","summary":"A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies is a phase 1/2 interventional study registered as NCT05006716 by BeOne Medicines, with 645 participants planned, started 2021-09-13 and due to reach its primary completion in 2026-11. Interventions recorded: Tacabrutideg. Conditions listed: B-cell Malignancy, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05006716","url":"https://clinicaltrials.gov/study/NCT05006716"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma","hodgkin-lymphoma","non-hodgkin-lymphoma","mantle-cell-lymphoma","dlbcl"],"sections":[],"technologies":["protac-degrader"],"targets":[],"drugs":["bgb-16673"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05006716","phase":"1/2","setting":"A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies","sponsor":"BeOne Medicines","started":"2021-09-13","startedType":"actual","enrolled":645,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05736406","kind":"trial","name":"A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma","aka":[],"tldr":"A phase 1/2 trial of Aminolevulinic acid (topical, for photodynamic therapy) in glioma & glioblastoma, run by Hemerion Therapeutics, active and no longer recruiting.","summary":"A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma is a phase 1/2 interventional study registered as NCT05736406 by Hemerion Therapeutics, with 12 participants enrolled, started 2024-02-20 and due to reach its primary completion in 2026-03-06. Interventions recorded: 5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 200 J/cm^2 and 5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 400 J/cm^2.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05736406","url":"https://clinicaltrials.gov/study/NCT05736406"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["precancer-ablation"],"targets":[],"drugs":["aminolevulinic-acid"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05736406","phase":"1/2","setting":"An Interventional, Multicenter, and International Phase 1/2, Light-dose-escalation Study to Investigate the Safety and Feasibility of Intraoperative Photodynamic Therapy (PDT) With Pentalafen® Drug and Heliance® Solution Device in Male and Female Patients 18 to 75 Years of Age With Grade IV Glioblastoma.","sponsor":"Hemerion Therapeutics","started":"2024-02-20","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02441309","kind":"trial","name":"A Eurosarc Study of Mifamurtide in Advanced Osteosarcoma (MEMOS)","aka":["MEMOS"],"tldr":"A phase 2 trial of Mifamurtide and Ifosfamide in Osteosarcoma, run by University of Oxford, recorded as terminated on the registry.","summary":"A Eurosarc Study of Mifamurtide in Advanced Osteosarcoma (MEMOS) is a phase 2 interventional study registered as NCT02441309 by University of Oxford, with 8 participants recorded, started 2014-10 and due to reach its primary completion in 2016-11-04. Interventions recorded: Mifamurtide, Ifosfamide. Conditions recorded: Osteosarcoma.\n\nLinked to the drug Mifamurtide because the registry names it among its interventions and Osteosarcoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02441309","url":"https://clinicaltrials.gov/study/NCT02441309"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["osteosarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["mifamurtide","ifosfamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02441309","phase":"2","setting":"A Mechanistic Study Of Mifamurtide (MTP-PE) In Patients With Metastatic And/Or Recurrent Osteosarcoma","sponsor":"University of Oxford","started":"2014-10","startedType":"actual","yearReported":2019,"enrolled":8,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease Specific Overall Survival","unit":"months","arms":[{"name":"A. Mifamurtide Only","n":3,"value":0.7,"note":"95% CI 0.2 to NA; Figures from the ClinicalTrials.gov results section (first posted 2019-09-13), not from a publication"},{"name":"B. Ifosfamide (Followed by Mifamurtide)","n":2,"value":9.2,"note":"95% CI 9.2 to NA"},{"name":"C. Ifosfamide + Mifamurtide","n":3,"value":2.8,"note":"95% CI 1.5 to NA"}],"source":"https://clinicaltrials.gov/study/NCT02441309?tab=results"},{"endpoint":"Progression Free Survival","unit":"months","arms":[{"name":"A. Mifamurtide Only","n":3,"note":"No events were observed, median is undefined.; Figures from the ClinicalTrials.gov results section (first posted 2019-09-13), not from a publication"},{"name":"B. Ifosfamide (Followed by Mifamurtide)","n":2,"note":"No events were observed, median is undefined."},{"name":"C. Ifosfamide + Mifamurtide","n":3,"value":7,"note":"95% CI 4.6 to NA"}],"source":"https://clinicaltrials.gov/study/NCT02441309?tab=results"}]},{"id":"nct07255664","kind":"trial","name":"A FIH, Phase I/IIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC","aka":["ProbeTILity"],"tldr":"A phase 1/2 trial of Pembrolizumab, Mesna in colorectal cancer and prostate cancer, run by CuraCell TX AB, now recruiting.","summary":"A FIH, Phase I/IIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC is a phase 1/2 interventional study registered as NCT07255664 by CuraCell TX AB, with 12 participants planned, started 2025-11-13 and due to reach its primary completion in 2027-04. Interventions recorded: CC-38, Pembrolizumab, Cyclophosphamid, Interleukin-2, Uromitexan. Conditions listed: Metastatic Colorectal Cancer, Prostate Cancer Metastatic, Prostate Cancer Locally Advanced. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07255664","url":"https://clinicaltrials.gov/study/NCT07255664"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","mesna"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07255664","phase":"1/2","setting":"A FIH, Phase I/IIa, Open-label Trial Assessing Safety, Tolerability, and Feasibility of Repeated Administrations of a Novel Autologous TIL-based Immunotherapy in Patients With Metastatic Colorectal or Prostate Cancer","sponsor":"CuraCell TX AB","started":"2025-11-13","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06413680","kind":"trial","name":"A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Hav","aka":["BrILliance"],"tldr":"A phase 1/2 trial of Cemiplimab in melanoma and renal cell carcinoma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body is a phase 1/2 interventional study registered as NCT06413680 by Regeneron Pharmaceuticals, with 240 participants planned, started 2024-09-23 and due to reach its primary completion in 2030-02-03. Interventions recorded: REGN10597, Cemiplimab. Conditions listed: Melanoma, Clear-Cell Renal-Cell Carcinoma (ccRCC), Advanced Solid Tumors. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06413680","url":"https://clinicaltrials.gov/study/NCT06413680"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","rcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06413680","phase":"1/2","setting":"A Phase 1/2a, Open-Label, Dose Escalation and Dose Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti-PD-1-IL-2RA-IL-2 Fusion Protein) Alone or in Combination With Cemiplimab in Patients With Advanced Solid Organ Malignancies","sponsor":"Regeneron Pharmaceuticals","started":"2024-09-23","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06188520","kind":"trial","name":"A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With ","aka":["CYCAD-1"],"tldr":"A phase 1/2 trial of Camizestrant, Ribociclib, Palbociclib in ovarian cancer, run by AstraZeneca, now recruiting.","summary":"A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06188520 by AstraZeneca, with 564 participants planned, started 2023-12-05 and due to reach its primary completion in 2027-08-04. Interventions recorded: AZD8421, Camizestrant, Ribociclib, Palbociclib, Abemaciclib. Conditions listed: ER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06188520","url":"https://clinicaltrials.gov/study/NCT06188520"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["camizestrant","ribociclib","palbociclib","abemaciclib","azd8421"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06188520","phase":"1/2","setting":"A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors","sponsor":"AstraZeneca","started":"2023-12-05","startedType":"actual","enrolled":564,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07354711","kind":"trial","name":"A First-in-human Study of 3H-10000 in Patients With Unresectable or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of 3H-10000 in gastric & gastro-oesophageal junction cancer, run by 3H Pharmaceuticals Co., Ltd., now recruiting.","summary":"A First-in-human Study of 3H-10000 in Patients With Unresectable or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT07354711 by 3H Pharmaceuticals Co., Ltd., with 170 participants planned, started 2026-01-04 and due to reach its primary completion in 2028-01. Interventions recorded: 3H-10000.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07354711","url":"https://clinicaltrials.gov/study/NCT07354711"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["adc"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07354711","phase":"1/2","setting":"A Phase I/II Study of 3H-10000 (an Anti-FGFR2b Antibody-Drug Conjugate) in Subjects With Unresectable or Metastatic Advanced Solid Tumors","sponsor":"3H Pharmaceuticals Co., Ltd.","started":"2026-01-04","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07439094","kind":"trial","name":"A First-in-Human Study of CKD-703 in Advanced Solid Tumors and Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of CKD-703 in non-small-cell lung cancer, run by Chong Kun Dang Pharmaceutical, now recruiting.","summary":"A First-in-Human Study of CKD-703 in Advanced Solid Tumors and Non-Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT07439094 by Chong Kun Dang Pharmaceutical, with 140 participants planned, started 2026-04-16 and due to reach its primary completion in 2029-12. Interventions recorded: CKD-703.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07439094","url":"https://clinicaltrials.gov/study/NCT07439094"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","met-altered-nsclc"],"sections":[],"technologies":[],"targets":["met"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07439094","phase":"1/2","setting":"A First-in-Human, Multicenter, Open-Label, Phase 1/2a Study to Evaluate the Safety, Efficacy and Pharmacokinetics of CKD-703 in Advanced c-Met Expressing Solid Tumors, and in MET Amplified and c-Met Overexpressing Non-Small Cell Lung Cancer","sponsor":"Chong Kun Dang Pharmaceutical","started":"2026-04-16","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05589896","kind":"trial","name":"A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies","aka":[],"tldr":"A phase 1/2 trial of an investigational treatment in acute lymphoblastic leukaemia, acute myeloid leukaemia, chronic lymphocytic leukaemia, chronic myeloid leukaemia, myelodysplastic syndromes / neoplasms and hodgkin lymphoma, run by Ossium Health, Inc., active and no longer recruiting.","summary":"A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies is a phase 1/2 interventional study registered as NCT05589896 by Ossium Health, Inc., with 12 participants enrolled, started 2024-08-16 and due to reach its primary completion in 2026-07-14.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05589896","url":"https://clinicaltrials.gov/study/NCT05589896"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","aml","cll","cml","mds","hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05589896","phase":"1/2","setting":"A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies","sponsor":"Ossium Health, Inc.","started":"2024-08-16","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05636215","kind":"trial","name":"A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of IBI354 in advanced solid tumours, run by Innovent Biologics (Suzhou) Co. Ltd., now recruiting.","summary":"A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05636215 by Innovent Biologics (Suzhou) Co. Ltd., with 368 participants planned, started 2023-04-04 and due to reach its primary completion in 2025-04-30. Interventions recorded: IBI354.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05636215","url":"https://clinicaltrials.gov/study/NCT05636215"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ibi354"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05636215","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open-label Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","started":"2023-04-04","startedType":"actual","enrolled":368,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06253130","kind":"trial","name":"A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of IMP1734 in advanced solid tumours, run by Eikon Therapeutics, now recruiting.","summary":"A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06253130 by Eikon Therapeutics, with 156 participants planned, started 2023-12-11 and due to reach its primary completion in 2027-06-01. Interventions recorded: IMP1734.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06253130","url":"https://clinicaltrials.gov/study/NCT06253130"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["imp1734"],"companies":["eikon-therapeutics","impact-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06253130","phase":"1/2","setting":"A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation, Dose-optimization, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PARP1 Selective Inhibitor, IMP1734, as Monotherapy in Patients With Advanced Solid Tumors","sponsor":"Eikon Therapeutics","started":"2023-12-11","startedType":"actual","enrolled":156,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06921837","kind":"trial","name":"A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer","aka":[],"tldr":"A phase 1/2 trial of BDC-4182 in gastric & gastro-oesophageal junction cancer and oesophageal cancer, run by Bolt Biotherapeutics, Inc., now recruiting.","summary":"A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer is a phase 1/2 interventional study registered as NCT06921837 by Bolt Biotherapeutics, Inc., with 122 participants planned, started 2025-05-26 and due to reach its primary completion in 2027-05. Interventions recorded: BDC-4182.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06921837","url":"https://clinicaltrials.gov/study/NCT06921837"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","esophageal"],"sections":[],"technologies":[],"targets":[],"drugs":["bdc-4182"],"companies":["bolt-biotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06921837","phase":"1/2","setting":"A Phase 1/2, First-in-Human, Dose Escalation and Expansion Study of BDC-4182 as a Single Agent in Patients With Advanced Gastric and Gastroesophageal Cancer","sponsor":"Bolt Biotherapeutics, Inc.","started":"2025-05-26","startedType":"actual","enrolled":122,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07629960","kind":"trial","name":"A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations","aka":[],"tldr":"A phase 1/2 trial of BLU-924 in non-small-cell lung cancer, colorectal cancer and pancreatic ductal adenocarcinoma, run by Blueprint Medicines Corporation, now recruiting.","summary":"A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations is a phase 1/2 interventional study registered as NCT07629960 by Blueprint Medicines Corporation, with 265 participants planned, started 2026-06-04 and due to reach its primary completion in 2029-09. Interventions recorded: BLU-924.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07629960","url":"https://clinicaltrials.gov/study/NCT07629960"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","colorectal","pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["blueprint-medicines","sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07629960","phase":"1/2","setting":"A Phase 1/2, Open-Label, Dose-Escalation, Dose-Enrichment, and Dose-Expansion Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BLU-924 (SAR449336) as Monotherapy and Combination Therapy in Participants With Advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Harboring KRAS Mutations","sponsor":"Blueprint Medicines Corporation","started":"2026-06-04","startedType":"actual","enrolled":265,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07220616","kind":"trial","name":"A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies","aka":[],"tldr":"A phase 1/2 trial of DS3790a in non-Hodgkin lymphoma, run by Daiichi Sankyo, now recruiting.","summary":"A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies is a phase 1/2 interventional study registered as NCT07220616 by Daiichi Sankyo, with 420 participants planned, started 2026-01-16 and due to reach its primary completion in 2030-11-30. Interventions recorded: DS3790a and Combination drug.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07220616","url":"https://clinicaltrials.gov/study/NCT07220616"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07220616","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open-Label, Multi-Cohort, First-in Human Trial of DS3790a, a DXd-ADC Targeting CD37, for Hematological Malignancies","sponsor":"Daiichi Sankyo","started":"2026-01-16","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05908643","kind":"trial","name":"A First-In-Human Trial of pTTL in Advanced Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of pTTL in colorectal cancer, run by Neogap Therapeutics AB, now recruiting.","summary":"A First-In-Human Trial of pTTL in Advanced Colorectal Cancer is a phase 1/2 interventional study registered as NCT05908643 by Neogap Therapeutics AB, with 16 participants planned, started 2023-03-15 and due to reach its primary completion in 2027-12. Interventions recorded: pTTL.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05908643","url":"https://clinicaltrials.gov/study/NCT05908643"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05908643","phase":"1/2","setting":"A First-In-Human, Phase I/IIa Trial of the Novel T Cell Immunotherapy pTTL in Patients With Advanced Colorectal Cancer","sponsor":"Neogap Therapeutics AB","started":"2023-03-15","startedType":"actual","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05584670","kind":"trial","name":"A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Cetuximab, ADG126, Bevacizumab, Nivolumab and Ipilimumab in advanced solid tumours, run by Sanofi, now recruiting.","summary":"A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05584670 by Sanofi, with 542 participants planned, started 2022-11-29 and due to reach its primary completion in 2027-01-19. Interventions recorded: SAR445877, Cetuximab, ADG126, Bevacizumab, Nivolumab and Ipilimumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05584670","url":"https://clinicaltrials.gov/study/NCT05584670"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cetuximab","adg126","bevacizumab","nivolumab","ipilimumab"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05584670","phase":"1/2","setting":"A Phase 1/2, Open Label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR445877 Administered as Monotherapy or in Combination With Other Anticancer Therapies in Adults With Advanced Solid Tumors","sponsor":"Sanofi","started":"2022-11-29","startedType":"actual","enrolled":542,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07147348","kind":"trial","name":"A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of PM8002 in advanced solid tumours, run by BioNTech SE, now recruiting.","summary":"A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07147348 by BioNTech SE, with 375 participants planned, started 2025-08-27 and due to reach its primary completion in 2027-11. Interventions recorded: BNT3212 and Pumitamig.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07147348","url":"https://clinicaltrials.gov/study/NCT07147348"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07147348","phase":"1/2","setting":"A Phase I/II, First-in-human, Open-label, Dose Escalation and Indication Expansion Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors","sponsor":"BioNTech SE","started":"2025-08-27","startedType":"actual","enrolled":375,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04686682","kind":"trial","name":"A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors","aka":[],"tldr":"A phase 1/2 trial of JAB-8263 in non-small-cell lung cancer, small-cell lung cancer and ovarian cancer, run by Jacobio Pharmaceuticals Co., Ltd., now recruiting.","summary":"A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors is a phase 1/2 interventional study registered as NCT04686682 by Jacobio Pharmaceuticals Co., Ltd., with 152 participants planned, started 2021-05-07 and due to reach its primary completion in 2028-01. Interventions recorded: JAB-8263.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04686682","url":"https://clinicaltrials.gov/study/NCT04686682"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["jacobio-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04686682","phase":"1/2","setting":"A Phase I/IIa, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Patients With Advanced Malignant Tumors","sponsor":"Jacobio Pharmaceuticals Co., Ltd.","started":"2021-05-07","startedType":"actual","enrolled":152,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05731271","kind":"trial","name":"A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of TST003 in colorectal cancer, run by Transcenta Therapeutics (Hangzhou) Co., Ltd., active and no longer recruiting.","summary":"A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors is a phase 1/2 interventional study registered as NCT05731271 by Transcenta Therapeutics (Hangzhou) Co., Ltd., with 111 participants enrolled, started 2023-02-08 and due to reach its primary completion in 2026-06. Interventions recorded: TST003.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05731271","url":"https://clinicaltrials.gov/study/NCT05731271"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["tst003"],"companies":["transcenta"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05731271","phase":"1/2","setting":"A First-in-Human, Open-Label, Multi-Center Phase 1 Study of TST003 in Subjects With Locally Advanced or Metastatic Solid Tumors","sponsor":"Transcenta Therapeutics (Hangzhou) Co., Ltd.","started":"2023-02-08","startedType":"actual","enrolled":111,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06277219","kind":"trial","name":"A First-in-Human, Phase 1/2 Study of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1)","aka":["LIGHTSPEED-1"],"tldr":"A phase 1/2 trial of LAT010 in advanced solid tumours, run by Latticon Antibody Therapeutics, Inc, now recruiting.","summary":"A First-in-Human, Phase 1/2 Study of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1) is a phase 1/2 interventional study registered as NCT06277219 by Latticon Antibody Therapeutics, Inc, with 150 participants planned, started 2024-06-05 and due to reach its primary completion in 2026-12. Interventions recorded: LAT010 and LAT010 + ICI.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06277219","url":"https://clinicaltrials.gov/study/NCT06277219"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06277219","phase":"1/2","setting":"A Phase 1/2, Dose-Escalation and Cohort-Expansion Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Efficacy of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1)","sponsor":"Latticon Antibody Therapeutics, Inc","started":"2024-06-05","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06363994","kind":"trial","name":"A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL","aka":[],"tldr":"A phase 3 trial of Orelabrutinib, Bendamustine, Rituximab in mantle cell lymphoma, run by InnoCare Pharma Inc., now recruiting.","summary":"A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL is a phase 3 interventional study registered as NCT06363994 by InnoCare Pharma Inc., with 476 participants planned, started 2024-05-29 and due to reach its primary completion in 2031-06-25. Interventions recorded: Orelabrutinib, Bendamustine Injection, Rituximab, Orelabrutinib Placebo. Conditions listed: Mantle Cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06363994","url":"https://clinicaltrials.gov/study/NCT06363994"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["orelabrutinib","bendamustine","rituximab"],"companies":["innocare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06363994","phase":"3","setting":"A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma","sponsor":"InnoCare Pharma Inc.","started":"2024-05-29","startedType":"actual","enrolled":476,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07459751","kind":"trial","name":"A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2/3 trial testing HLX43 in non-small-cell lung cancer, now recruiting.","summary":"A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer is a phase 2/3 interventional study registered as NCT07459751, led by Shanghai Henlius Biotech, and recruiting on the registry. Official title: A Randomised, Open-Label, Multi-centre, Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) Monotherapy or HLX43 in Combination With HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC). Planned enrolment is 706 participants (estimated). The study started in 2026-05-27 and primary completion is expected in 2030-01-15. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07459751","url":"https://clinicaltrials.gov/study/NCT07459751"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["hlx43"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07459751","phase":"2/3","setting":"A Randomized, Open-Label, Multi-center, Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) Monotherapy or HLX43 in Combination With HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Shanghai Henlius Biotech","started":"2026-05-27","startedType":"actual","enrolled":706,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06868277","kind":"trial","name":"A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer","aka":["ARTEMIDE-Lung04"],"tldr":"A phase 3 trial of Rilvegostomig and Pembrolizumab in non-small-cell lung cancer, run by AstraZeneca, now recruiting.","summary":"A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT06868277 by AstraZeneca, with 830 participants planned, started 2025-04-10 and due to reach its primary completion in 2030-01-17. Interventions recorded: Rilvegostomig and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06868277","url":"https://clinicaltrials.gov/study/NCT06868277"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["rilvegostomig","pembrolizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06868277","phase":"3","setting":"A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)","sponsor":"AstraZeneca","started":"2025-04-10","startedType":"actual","enrolled":830,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06627647","kind":"trial","name":"A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous N","aka":["ARTEMIDE-Lung03"],"tldr":"A phase 3 trial of Rilvegostomig, Pembrolizumab, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, now recruiting.","summary":"A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC is a phase 3 interventional study registered as NCT06627647 by AstraZeneca, with 1160 participants planned, started 2024-11-27 and due to reach its primary completion in 2030-11-18. Interventions recorded: Rilvegostomig, Pembrolizumab, Carboplatin, Cisplatin, Pemetrexed. Conditions listed: Non-squamous Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06627647","url":"https://clinicaltrials.gov/study/NCT06627647"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["rilvegostomig","pembrolizumab","carboplatin","cisplatin","pemetrexed"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06627647","phase":"3","setting":"A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)","sponsor":"AstraZeneca","started":"2024-11-27","startedType":"actual","enrolled":1160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06692738","kind":"trial","name":"A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-s","aka":["ARTEMIDE-Lung02"],"tldr":"A phase 3 trial of Rilvegostomig, Pembrolizumab, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, now recruiting.","summary":"A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) is a phase 3 interventional study registered as NCT06692738 by AstraZeneca, with 1160 participants planned, started 2024-11-18 and due to reach its primary completion in 2030-07-01. Interventions recorded: Rilvegostomig, Pembrolizumab, Carboplatin, Paclitaxel, Nab-paclitaxel. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06692738","url":"https://clinicaltrials.gov/study/NCT06692738"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["rilvegostomig","pembrolizumab","carboplatin","paclitaxel"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06692738","phase":"3","setting":"A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)","sponsor":"AstraZeneca","started":"2024-11-18","startedType":"actual","enrolled":1160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03591510","kind":"trial","name":"A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML","aka":[],"tldr":"A phase 2 trial of Midostaurin, Fludarabine, Cytarabine, Daunorubicin, Idarubicin and Mitoxantrone in acute myeloid leukaemia, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML is a phase 2 interventional study registered as NCT03591510 by Novartis Pharmaceuticals, with 22 participants enrolled, started 2019-03-13 and due to reach its primary completion in 2029-05-18. Interventions recorded: Midostaurin, Fludarabine, Cytarabine, Daunorubicin or idarubicin, Mitoxantrone and Etoposide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03591510","url":"https://clinicaltrials.gov/study/NCT03591510"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-paediatric"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["midostaurin","fludarabine","cytarabine","daunorubicin","idarubicin","mitoxantrone"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03591510","phase":"2","setting":"A Phase II, Open-label, Single Arm Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Twice Daily Midostaurin (PKC412) Combined With Standard Chemotherapy and as a Single Agent Post-consolidation Therapy in Children With Untreated FLT3-mutated AML","sponsor":"Novartis Pharmaceuticals","started":"2019-03-13","startedType":"actual","enrolled":22,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05984277","kind":"trial","name":"A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung","aka":["eVOLVE-Lung02"],"tldr":"A phase 3 trial of Pembrolizumab, Carboplatin, Paclitaxel / nab-paclitaxel in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer. is a phase 3 interventional study registered as NCT05984277 by AstraZeneca, with 895 participants enrolled, started 2023-10-24 and due to reach its primary completion in 2029-02-28. Interventions recorded: Volrustomig, Pembrolizumab, Carboplatin, Paclitaxel, Pemetrexed. Conditions listed: Metastatic Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05984277","url":"https://clinicaltrials.gov/study/NCT05984277"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","carboplatin","paclitaxel","pemetrexed"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05984277","phase":"3","setting":"A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (mNSCLC).","sponsor":"AstraZeneca","started":"2023-10-24","startedType":"actual","enrolled":895,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05211895","kind":"trial","name":"A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC","aka":["PACIFIC-8"],"tldr":"A phase 3 trial testing Domvanalimab in non-small-cell lung cancer, active and no longer recruiting.","summary":"A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC is a phase 3 interventional study registered as NCT05211895, led by AstraZeneca with Arcus Biosciences, and active but no longer recruiting on the registry. Official title: A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab Plus Domvanalimab(AB154) in Participants With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease Has Not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy. Planned enrolment is 791 participants (actual). The study started in 2022-02-18 and primary completion is expected in 2026-08-10. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05211895","url":"https://clinicaltrials.gov/study/NCT05211895"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["domvanalimab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05211895","phase":"3","setting":"A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab Plus Domvanalimab(AB154) in Participants With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease Has Not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy","sponsor":"AstraZeneca","started":"2022-02-18","startedType":"actual","enrolled":791,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05221840","kind":"trial","name":"A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer","aka":["PACIFIC-9"],"tldr":"A phase 3 trial testing Oleclumab in non-small-cell lung cancer, active and no longer recruiting.","summary":"A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT05221840, led by AstraZeneca, and active but no longer recruiting on the registry. Official title: A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy. Planned enrolment is 1051 participants (actual). The study started in 2022-02-07 and primary completion is expected in 2026-09-30. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05221840","url":"https://clinicaltrials.gov/study/NCT05221840"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["oleclumab","monalizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05221840","phase":"3","setting":"A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy","sponsor":"AstraZeneca","started":"2022-02-07","startedType":"actual","enrolled":1051,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05120349","kind":"trial","name":"A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection","aka":["ADAURA2"],"tldr":"A phase 3 trial of Osimertinib in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection is a phase 3 interventional study registered as NCT05120349 by AstraZeneca, with 390 participants enrolled, started 2022-02-21 and due to reach its primary completion in 2027-08-02. Interventions recorded: Osimertinib, Placebo. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05120349","url":"https://clinicaltrials.gov/study/NCT05120349"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05120349","phase":"3","setting":"A Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to Assess the Efficacy and Safety of Adjuvant Osimertinib Versus Placebo in Participants With EGFR Mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, Following Complete Tumour Resection","sponsor":"AstraZeneca","started":"2022-02-21","startedType":"actual","enrolled":390,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07796763","kind":"trial","name":"A Global Trial of Trastuzumab Rezetecan (SHR-A1811) in Combination With Chemotherapy and Bevacizumab as First-Line Treatment in Patients With Advanced Colorecta","aka":["HORIZON-CRC221"],"tldr":"A phase 2 trial in colorectal cancer, run by Jiangsu HengRui Medicine Co., Ltd., not yet recruiting.","summary":"A Global Trial of Trastuzumab Rezetecan (SHR-A1811) in Combination With Chemotherapy and Bevacizumab as First-Line Treatment in Patients With Advanced Colorectal Cancer Expressing HER2 is a phase 2, randomised interventional study registered as NCT07796763 by Jiangsu HengRui Medicine Co., Ltd., with a registry enrolment figure of 48 participants, started 2026-11-01 and due to reach its primary completion in 2028-05-01. Interventions recorded: Trastuzumab Rezetecan (SHR-A1811) injection; high dose; Trastuzumab Rezetecan (SHR-A1811) injection; low dose. Conditions listed: Advanced Colorectal Cancer Expressing HER2. Primary outcome: Incidence of treatment-emergent adverse events; Determination of the recommended phase 3 dose. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed unresectable, recurrent, or metastatic colorectal adenocarcinoma that is HER2-positive\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07796763","url":"https://clinicaltrials.gov/study/NCT07796763"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","her2-amplified-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07796763","phase":"2","setting":"A Global, Multicenter, Randomized, Dose-Optimization Phase II Study of Trastuzumab Rezetecan (SHR-A1811) in Combination With mFOLFOX6 (-1) and Bevacizumab as First-Line Treatment in Patients With HER2-Positive Advanced Colorectal Cancer (HORIZON-CRC221)","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2026-11-01","startedType":"estimated","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07105215","kind":"trial","name":"A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of RC278 in advanced solid tumours, run by RemeGen Co., Ltd., now recruiting.","summary":"A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors is a phase 1/2 interventional study registered as NCT07105215 by RemeGen Co., Ltd., with 312 participants planned, started 2025-08-11 and due to reach its primary completion in 2027-12-31. Interventions recorded: RC278.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07105215","url":"https://clinicaltrials.gov/study/NCT07105215"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07105215","phase":"1/2","setting":"A Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC278 for Injection in the Treatment of Locally Advanced Unresectable or Metastatic Malignant Solid Tumor","sponsor":"RemeGen Co., Ltd.","started":"2025-08-11","startedType":"actual","enrolled":312,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07229638","kind":"trial","name":"A IB/II Phase Clinical Study on the Safety, Tolerability, and Efficacy of SHR-9839(sc) in Combination Anti-tumor Therapy in Patients With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SHR-9839(sc) For Injection in advanced solid tumours, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A IB/II Phase Clinical Study on the Safety, Tolerability, and Efficacy of SHR-9839(sc) in Combination Anti-tumor Therapy in Patients With Solid Tumors is a phase 1/2 interventional study registered as NCT07229638 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 70 participants planned, started 2026-02-27 and due to reach its primary completion in 2027-04. Interventions recorded: SHR-9839(sc) For Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07229638","url":"https://clinicaltrials.gov/study/NCT07229638"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07229638","phase":"1/2","setting":"An Open-label, Multicenter Phase IB/II Clinical Study on the Safety, Tolerability, and Efficacy of SHR-9839(sc) in Combination Anti-tumor Therapy in Patients With Solid Tumors","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2026-02-27","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05934331","kind":"trial","name":"A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study","aka":[],"tldr":"A phase 2 trial of LM-302, Toripalimab, Capecitabine, Nivolumab, Rivoceranib (apatinib) and Gemcitabine in advanced solid tumours, run by LaNova Medicines Zhejiang Co., Ltd., now recruiting.","summary":"A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study is a phase 2 interventional study registered as NCT05934331 by LaNova Medicines Zhejiang Co., Ltd., with 276 participants planned, started 2023-07-27 and due to reach its primary completion in 2026-07-01. Interventions recorded: LM-302, Toripalimab, Capecitabine, Tegafur, Gimeracil and Oteracil Potassium Capsules, Nivolumab and Apatinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05934331","url":"https://clinicaltrials.gov/study/NCT05934331"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["lm-302","toripalimab","capecitabine","nivolumab","rivoceranib","gemcitabine"],"companies":["lanova-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05934331","phase":"2","setting":"An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of the LM-302 Combination With Other Anti-tumor Treatment in Subjects With CLDN18.2-positive Advanced Gastro-Intestinal Cancer.","sponsor":"LaNova Medicines Zhejiang Co., Ltd.","started":"2023-07-27","startedType":"actual","enrolled":276,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01804686","kind":"trial","name":"A Long-term Extension Study of PCI-32765 (Ibrutinib)","aka":[],"tldr":"A phase 3 trial of Ibrutinib in mantle cell lymphoma and follicular lymphoma, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Long-term Extension Study of PCI-32765 (Ibrutinib) is a phase 3 interventional study registered as NCT01804686 by Janssen Research & Development, LLC, with 700 participants planned, started 2013-09-09 and due to reach its primary completion in 2026-12-31. Interventions recorded: Ibrutinib. Conditions listed: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01804686","url":"https://clinicaltrials.gov/study/NCT01804686"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma","follicular-lymphoma","dlbcl"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ibrutinib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01804686","phase":"3","setting":"PCI-32765CAN3001: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study","sponsor":"Janssen Research & Development, LLC","started":"2013-09-09","startedType":"actual","enrolled":700,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04641247","kind":"trial","name":"A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study","aka":[],"tldr":"A phase 2 trial of Niraparib in ovarian cancer, run by GlaxoSmithKline, now recruiting.","summary":"A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study is a phase 2 interventional study registered as NCT04641247 by GlaxoSmithKline, with 37 participants planned, started 2021-04-16 and due to reach its primary completion in 2026-12-28. Interventions recorded: Niraparib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04641247","url":"https://clinicaltrials.gov/study/NCT04641247"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["niraparib"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04641247","phase":"2","setting":"An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline/TESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib","sponsor":"GlaxoSmithKline","started":"2021-04-16","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05999994","kind":"trial","name":"A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer","aka":["CAMPFIRE"],"tldr":"A phase 2 trial of Ramucirumab, Cyclophosphamide, Vinorelbine, Gemcitabine, Docetaxel and Abemaciclib in advanced solid tumours, run by Eli Lilly and Company, now recruiting.","summary":"A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer is a phase 2 interventional study registered as NCT05999994 by Eli Lilly and Company, with 105 participants planned, started 2020-01-22 and due to reach its primary completion in 2027-05. Interventions recorded: Ramucirumab, Cyclophosphamide, Vinorelbine, Gemcitabine, Docetaxel and Abemaciclib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05999994","url":"https://clinicaltrials.gov/study/NCT05999994"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ramucirumab","cyclophosphamide","vinorelbine","gemcitabine","docetaxel","abemaciclib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05999994","phase":"2","setting":"CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research","sponsor":"Eli Lilly and Company","started":"2020-01-22","startedType":"actual","enrolled":105,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06630234","kind":"trial","name":"A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)","aka":[],"tldr":"A phase 1/2 trial of DCC-3009 in gastrointestinal stromal tumour, run by Deciphera Pharmaceuticals, LLC, now recruiting.","summary":"A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST) is a phase 1/2 interventional study registered as NCT06630234 by Deciphera Pharmaceuticals, LLC, with 120 participants planned, started 2024-12-10 and due to reach its primary completion in 2028-05. Interventions recorded: DCC-3009.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06630234","url":"https://clinicaltrials.gov/study/NCT06630234"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gist"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06630234","phase":"1/2","setting":"A Master Protocol for the Multi-cohort, Open-label, Phase 1/2 Study of DCC-3009 in Participants With Gastrointestinal Stromal Tumor (GIST)","sponsor":"Deciphera Pharmaceuticals, LLC","started":"2024-12-10","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06600789","kind":"trial","name":"A Modular Phase 1/2 Study With CT7439 in Participants With Solid Malignancies","aka":[],"tldr":"A phase 1/2 trial of CT7439 Capsules (0.5 mg, 1mg, 3mg, 10mg, 15mg, 20mg) in advanced solid tumours, run by Carrick Therapeutics Limited, now recruiting.","summary":"A Modular Phase 1/2 Study With CT7439 in Participants With Solid Malignancies is a phase 1/2 interventional study registered as NCT06600789 by Carrick Therapeutics Limited, with 50 participants planned, started 2024-08-16 and due to reach its primary completion in 2027-03-14. Interventions recorded: CT7439 Capsules (0.5 mg, 1mg, 3mg, 10mg, 15mg, 20mg).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06600789","url":"https://clinicaltrials.gov/study/NCT06600789"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06600789","phase":"1/2","setting":"A Modular, Multi-Part, Multi-Arm, Phase 1/2 Study to Evaluate the Safety and Tolerability of CT7439 Alone and in Combination With Anticancer Treatments in Participants With Solid Malignancies","sponsor":"Carrick Therapeutics Limited","started":"2024-08-16","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07681596","kind":"trial","name":"A Modular, Phase I/II, Multicentre Study to Evaluate AZD4045, in Participants With Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 1/2 trial of AZD4045, Daratumumab, Aldesleukin in multiple myeloma, run by AstraZeneca, now recruiting.","summary":"A Modular, Phase I/II, Multicentre Study to Evaluate AZD4045, in Participants With Relapsed or Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT07681596 by AstraZeneca, with 101 participants planned, started 2026-07-27 and due to reach its primary completion in 2031-03-06. Interventions recorded: AZD4045, Daratumumab, Aldesleukin. Conditions listed: Relapsed or Refractory Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07681596","url":"https://clinicaltrials.gov/study/NCT07681596"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["azd4045","daratumumab","aldesleukin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07681596","phase":"1/2","setting":"A Modular, Phase I/II, Open-label, Multicentre Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Efficacy of AZD4045, an Allogeneic Chimeric Antigen Receptor-T Cell (CAR-T) Therapy Targeting B Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma","sponsor":"AstraZeneca","started":"2026-07-27","startedType":"actual","enrolled":101,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03934567","kind":"trial","name":"A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma","aka":[],"tldr":"A phase 2 trial of Abexinostat in non-Hodgkin lymphoma, run by Xynomic Pharmaceuticals, Inc., active and no longer recruiting.","summary":"A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma is a phase 2 interventional study registered as NCT03934567 by Xynomic Pharmaceuticals, Inc., with 87 participants enrolled, started 2020-04-22 and due to reach its primary completion in 2025-01-29. Interventions recorded: Abexinostat.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03934567","url":"https://clinicaltrials.gov/study/NCT03934567"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["abexinostat"],"companies":["xynomic-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03934567","phase":"2","setting":"An Open-label, Single-arm, Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Oral Histone Deacetylase (HDAC)-Inhibitor Abexinostat, as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma (FL)","sponsor":"Xynomic Pharmaceuticals, Inc.","started":"2020-04-22","startedType":"actual","enrolled":87,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05862064","kind":"trial","name":"A Multi-center, Randomized, Open-label, Phase III Study Comparing PD-1 Inhibitor Combined With Antivascular Therapy and Anthracycline/Taxane-based Adjuvant Chem","aka":[],"tldr":"A phase 3 trial of epirubicin, cyclophosphamide and paclitaxel / nab-paclitaxel in triple-negative breast cancer, run by Fudan University, now recruiting.","summary":"A Multi-center, Randomized, Open-label, Phase III Study Comparing PD-1 Inhibitor Combined With Antivascular Therapy and Anthracycline/Taxane-based Adjuvant Chemotherapy Versus Anthracycline/Taxane-based Adjuvant Chemotherapy Alone in Patients With Operable Triple-negative Breast Cancer is a phase 3, randomised interventional study registered as NCT05862064 by Fudan University, with a registry enrolment figure of 606 participants, started 2023-06-01 and due to reach its primary completion in 2026-07-01. Interventions recorded: epirubicin,cyclophosphamide,paclitaxel,Carrelizumab; epirubicin,cyclophosphamide,paclitaxel. Conditions listed: TNBC - Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Have stage IIA-IIIIC triple-negative breast cancer with non-metastatic surgically treated: pT1-3N1-3M0\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05862064","url":"https://clinicaltrials.gov/study/NCT05862064"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["epirubicin","cyclophosphamide","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05862064","phase":"3","setting":"A Multi-center, Randomized, Open-label, Phase III Study Comparing PD-1 Inhibitor Combined With Antivascular Therapy and Anthracycline/Taxane-based Adjuvant Chemotherapy Versus Anthracycline/Taxane-based Adjuvant Chemotherapy Alone in Patients With Operable Triple-negative Breast Cancer","sponsor":"Fudan University","started":"2023-06-01","startedType":"actual","enrolled":606,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04256317","kind":"trial","name":"A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)","aka":["AZTOUND"],"tldr":"A phase 2/3 trial of Azacitidine and Venetoclax in myelodysplastic syndromes / neoplasms, acute myeloid leukaemia and chronic myelomonocytic leukaemia and MDS/MPN overlap neoplasms, run by Taiho Oncology, Inc., now recruiting.","summary":"A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) is a phase 2/3 interventional study registered as NCT04256317 by Taiho Oncology, Inc., with 316 participants planned, started 2020-05-21 and due to reach its primary completion in 2027-11-01. Interventions recorded: Azacitidine, ASTX030 (cedazuridine + azacitidine), Cedazuridine and Venetoclax.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04256317","url":"https://clinicaltrials.gov/study/NCT04256317"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mds","aml","cmml"],"sections":[],"technologies":["bcl2-inhibitors","cytotoxic-chemotherapy","epigenetic-drugs","kinase-inhibitors"],"targets":[],"drugs":["azacitidine","venetoclax"],"companies":["araris"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04256317","phase":"2/3","setting":"A Multi-phase, Pharmacokinetics, Safety, and Efficacy Study of ASTX030 (Azacitidine and Cedazuridine) as Monotherapy in Subjects With Myeloid Neoplasm or in Combination With Venetoclax in Subjects With AML (AZTOUND Study)","sponsor":"Taiho Oncology, Inc.","started":"2020-05-21","startedType":"actual","enrolled":316,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06376136","kind":"trial","name":"A Multicenter Open Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of BAT 8010 for Injection Combined With BAT 1006 in the Treatment of Locally Advanced or Metastatic Tumors","aka":[],"tldr":"A phase 1/2 trial of BAT8010 for Injection in advanced solid tumours, run by Bio-Thera Solutions, now recruiting.","summary":"A Multicenter Open Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of BAT 8010 for Injection Combined With BAT 1006 in the Treatment of Locally Advanced or Metastatic Tumors is a phase 1/2 interventional study registered as NCT06376136 by Bio-Thera Solutions, with 216 participants planned, started 2024-05-08 and due to reach its primary completion in 2026-11-09. Interventions recorded: BAT8010 for Injection and BAT1006 for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06376136","url":"https://clinicaltrials.gov/study/NCT06376136"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bio-thera-solutions"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06376136","phase":"1/2","setting":"An Evaluation of BAT 8010 for Injection in Combination With BAT 1006 in Locally Advanced or Metastatic Entities Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of the Tumor in Patients Multicenter, Open Phase Ib/IIa Clinical Study","sponsor":"Bio-Thera Solutions","started":"2024-05-08","startedType":"actual","enrolled":216,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06412198","kind":"trial","name":"A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations","aka":[],"tldr":"A phase 1/2 trial of cetuximab, cemiplimab and adagrasib in colorectal cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations is a phase 1/2, interventional study registered as NCT06412198 by M.D. Anderson Cancer Center, with a registry enrolment figure of 31 participants, started 2024-08-28 and due to reach its primary completion in 2029-03-01. Interventions recorded: Cetuximab; Cemiplimab; Adagrasib. Conditions listed: Metastatic Colorectal Cancer; KRAS G12C Mutations. Primary outcome: Safety and adverse events (AEs). Colorectal eligibility wording from the registry: \"* Histologically confirmed diagnosis of advanced/metastatic microsatellite stable colorectal cancer with KRASG12C mutation with 1+ prior line(s) of therapy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06412198","url":"https://clinicaltrials.gov/study/NCT06412198"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","kras-g12c-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","kras-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["cetuximab","cemiplimab","adagrasib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06412198","phase":"1/2","setting":"A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations","sponsor":"M.D. Anderson Cancer Center","started":"2024-08-28","startedType":"actual","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05939661","kind":"trial","name":"A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer","aka":["AMBITION"],"tldr":"A phase 2 trial in colorectal cancer, run by Osaka University, now recruiting.","summary":"A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer is a phase 2, interventional study registered as NCT05939661 by Osaka University, with a registry enrolment figure of 45 participants, started 2023-05-25 and due to reach its primary completion in 2026-03-31. Interventions recorded: Radiation; Chemotherapy; Surgery. Conditions listed: Rectal Cancer. Primary outcome: Pathological complete response (pCR). Colorectal eligibility wording from the registry: \"The patient has adenocarcinoma of the rectum confirmed by histological examination\". Sites: Japan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05939661","url":"https://clinicaltrials.gov/study/NCT05939661"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05939661","phase":"2","setting":"A Multicenter Single-arm Phase 2 Study to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy of Short Course Radiation Therapy Followed by Neoadjuvant Oxaliplatin/Fluorouracil-based Chemotherapy (CAPOX) for cT2 Rectal Cancer.","sponsor":"Osaka University","started":"2023-05-25","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07333287","kind":"trial","name":"A Multicenter Single-arm Prospective Clinical Study on First-line Treatment of Pancreatic Cancer Liver Metastases With Arterial Infusion Chemotherapy and Emboli","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Shandong Provincial Hospital, not yet recruiting.","summary":"A Multicenter Single-arm Prospective Clinical Study on First-line Treatment of Pancreatic Cancer Liver Metastases With Arterial Infusion Chemotherapy and Embolization Combined With Dual Immune Checkpoint Inhibitors. is a phase 2, interventional study registered as NCT07333287 by Shandong Provincial Hospital, with a registry enrolment figure of 38 participants, started 2026-02-01 and due to reach its primary completion in 2027-02-28. Interventions recorded: Interventional; Targeted Therapy (anti-VEGF); Immunotherapy + Targeted Therapy; Immunotherapy + Targeted Therapy + Chemotherapy; This cycle is repeated every 21 days.. Conditions listed: Pancreatic Cancer Liver Metastases; Immunotherapy-naive. Primary outcome: Progression-Free Survival（PFS）. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed, previously untreated unresectable pancreatic ductal adenocarcinoma with liver metastases (TNM stage: IV)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07333287","url":"https://clinicaltrials.gov/study/NCT07333287"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07333287","phase":"2","setting":"A Multicenter Single-arm Prospective Clinical Study on First-line Treatment of Pancreatic Cancer Liver Metastases With Arterial Infusion Chemotherapy and Embolization Combined With Dual Immune Checkpoint Inhibitors.","sponsor":"Shandong Provincial Hospital","started":"2026-02-01","startedType":"estimated","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02448173","kind":"trial","name":"A Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by Vaccinogen Inc, not yet recruiting.","summary":"A Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer is a phase 3, randomised interventional study registered as NCT02448173 by Vaccinogen Inc, with a registry enrolment figure of 550 participants, started 2026-08 and due to reach its primary completion in 2031-08. Interventions recorded: OncoVAX and Surgery; Surgery. Conditions listed: Stage II Colon Cancer. Primary outcome: Disease-Free Survival. Colorectal eligibility wording from the registry: \"* Patients with more than one malignant primary colon cancer will be excluded\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02448173","url":"https://clinicaltrials.gov/study/NCT02448173"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02448173","phase":"3","setting":"A Randomized Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer","sponsor":"Vaccinogen Inc","started":"2026-08","startedType":"estimated","enrolled":550,"enrolledBasis":"registry","outcomes":[]},{"id":"g-hope-002","kind":"trial","name":"A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002)","aka":["G-HOPE-002"],"tldr":"A phase 3 trial testing IBI343 in pancreatic ductal adenocarcinoma, now recruiting.","summary":"A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002) is a phase 3 interventional study registered as NCT07066098, led by Innovent Biologics (Suzhou), and recruiting on the registry. Official title: A Multicenter, Randomised, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants With Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received>=2 Prior Lines of Therapy. Planned enrolment is 201 participants (estimated). The study started in 2025-08-04 and primary completion is expected in 2027-06-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07066098","url":"https://clinicaltrials.gov/study/NCT07066098"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["ibi343"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07066098","phase":"3","setting":"A Multicenter, Randomized, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants With Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received>=2 Prior Lines of Therapy","sponsor":"Innovent Biologics (Suzhou)","started":"2025-08-04","startedType":"actual","enrolled":201,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06838546","kind":"trial","name":"A Multicenter, Open Phase IIb Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Tasly Biopharmaceuticals Co., Ltd., not yet recruiting.","summary":"A Multicenter, Open Phase IIb Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT06838546 by Tasly Biopharmaceuticals Co., Ltd., with a registry enrolment figure of 80 participants, started 2025-02-24 and due to reach its primary completion in 2027-01-01. Interventions recorded: B1962. Conditions listed: Advanced Colorectal Cancer. Primary outcome: ORR. Colorectal eligibility wording from the registry: \"Patients with distant metastasis or unresectable locally advanced colorectal cancer who have disease progression or intolerable toxicities after previous standard treatment must include oxaliplatin, irinotecan and fluorouracil-based drugs in previous standard treatment regimen;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06838546","url":"https://clinicaltrials.gov/study/NCT06838546"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06838546","phase":"2","setting":"A Multicenter, Open Phase IIb Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Colorectal Cancer","sponsor":"Tasly Biopharmaceuticals Co., Ltd.","started":"2025-02-24","startedType":"estimated","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06724263","kind":"trial","name":"A Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Malignant Solid Tumors","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Tasly Biopharmaceuticals Co., Ltd., not yet recruiting.","summary":"A Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Malignant Solid Tumors is a phase 2, interventional study registered as NCT06724263 by Tasly Biopharmaceuticals Co., Ltd., with a registry enrolment figure of 120 participants, started 2024-12 and due to reach its primary completion in 2026-08. Interventions recorded: B1962. Conditions listed: Recurrent Platinum-resistant Epithelial Ovarian Cancer; Triple Negative Breast Cancer (TNBC); Cervical Cancers; Small Cell Lung Cancer; Hepatocellular Carcinoma (HCC); Colorectal Cancer; Non-Squamous Non-Small Cell Lung Cancer. Triple-negative eligibility wording from the registry: \"* Triple-negative breast cancer: pathologically confirmed unresectable locally advanced or metastatic breast cancer with negative ER, PR, and HER-2\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06724263","url":"https://clinicaltrials.gov/study/NCT06724263"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06724263","phase":"2","setting":"A Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Malignant Solid Tumors","sponsor":"Tasly Biopharmaceuticals Co., Ltd.","started":"2024-12","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07814066","kind":"trial","name":"A Multicenter, Open-label, Phase II Umbrella Study to Evaluate the Efficacy and Safety of the Investigational Product in Participants With Advanced or Metastati","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., not yet recruiting.","summary":"A Multicenter, Open-label, Phase II Umbrella Study to Evaluate the Efficacy and Safety of the Investigational Product in Participants With Advanced or Metastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT07814066 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with a registry enrolment figure of 30 participants, started 2026-10-31 and due to reach its primary completion in 2028-02-28. Interventions recorded: SKB571. Conditions listed: Pancreatic Cancer. Primary outcome: Objective response rate (ORR). Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed advanced or metastatic pancreatic cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07814066","url":"https://clinicaltrials.gov/study/NCT07814066"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07814066","phase":"2","setting":"A Multicenter, Open-label, Phase II Umbrella Study to Evaluate the Efficacy and Safety of the Investigational Product in Participants With Advanced or Metastatic Pancreatic Cancer","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-10-31","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07591597","kind":"trial","name":"A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus F","aka":["IGNITE-CRC"],"tldr":"A phase 1/2 trial of fruquintinib and pembrolizumab in colorectal cancer, run by National Cancer Center Hospital East, not yet recruiting.","summary":"A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS/pMMR Colorectal Cancer is a phase 1/2, interventional study registered as NCT07591597 by National Cancer Center Hospital East, with a registry enrolment figure of 68 participants, started 2026-05 and due to reach its primary completion in 2027-07. Interventions recorded: S-531011; Fruquintinib; Pembrolizumab. Conditions listed: Metastatic Colorectal Neoplasms; Microsatellite Stable / Proficient Mismatch Repair Colorectal Cancer. Primary outcome: Dose-Limiting Toxicity (DLT) Rate [Phase Ib Part]; Objective Response Rate (ORR) [Phase II Part]. Colorectal eligibility wording from the registry: \"Patients with histologically confirmed unresectable adenocarcinoma of the colon or rectum\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07591597","url":"https://clinicaltrials.gov/study/NCT07591597"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib","pembrolizumab"],"companies":["shionogi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07591597","phase":"1/2","setting":"A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS/pMMR Colorectal Cancer","sponsor":"National Cancer Center Hospital East","started":"2026-05","startedType":"estimated","enrolled":68,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06878625","kind":"trial","name":"A Multicenter, Prospective, Cohort Study of Trop-2 ADC Combination Therapy for Advanced Triple-negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of toripalimab in triple-negative breast cancer, run by Tianjin Medical University Cancer Institute and Hospital, now recruiting.","summary":"A Multicenter, Prospective, Cohort Study of Trop-2 ADC Combination Therapy for Advanced Triple-negative Breast Cancer is a phase 2, interventional study registered as NCT06878625 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 138 participants, started 2024-12-06 and due to reach its primary completion in 2027-06-30. Interventions recorded: Sacituzumab Govitecan combined with Toripalimab; Sacituzumab govitecan combined with anti-angiogenesis. Conditions listed: Evaluating the Efficacy of Trop-2 ADC Combination Therapy in Advanced Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Histologically confirmed triple-negative invasive breast cancer, defined as immunohistochemical detection of ER \\< 10%, PR \\< 10%, HER2 0-1+ or HER2 2+ with negative FISH or CISH results, in accordance with the 2018 ASCO-CAP HER2-negative identification guidelines\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06878625","url":"https://clinicaltrials.gov/study/NCT06878625"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06878625","phase":"2","setting":"A Multicenter, Prospective, Cohort Study Evaluating the Efficacy of Trop-2 ADC Combination Therapy in Advanced Triple-Negative Breast Cancer","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2024-12-06","startedType":"actual","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07632235","kind":"trial","name":"A Multicenter, Prospective, Randomized, Open-label Phase Ib/II Study of Celecoxib Plus Pembrolizumab and Gemcitabine/Cisplatin Versus Pembrolizumab and Gemcitabine/Cisplatin in Patients With CK5/6-High Unresectable Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma","aka":[],"tldr":"A phase 1/2 trial of pembrolizumab, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by Shanghai 6th People's Hospital, not yet recruiting.","summary":"A Multicenter, Prospective, Randomized, Open-label Phase Ib/II Study of Celecoxib Plus Pembrolizumab and Gemcitabine/Cisplatin Versus Pembrolizumab and Gemcitabine/Cisplatin in Patients With CK5/6-High Unresectable Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma is a phase 1/2, randomised interventional study registered as NCT07632235 by Shanghai 6th People's Hospital, with a registry enrolment figure of 112 participants, started 2026-09-15 and due to reach its primary completion in 2029-12-31. Interventions recorded: Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin, Pembrolizumab + Gemcitabine/Cisplatin. Conditions listed: Intrahepatic Cholangiocarcinoma (Icc). Gallbladder cancer is named in the registry entry: \"* Other primary malignancies including extrahepatic cholangiocarcinoma, gallbladder carcinoma, or ampullary carcinoma.\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07632235","url":"https://clinicaltrials.gov/study/NCT07632235"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","ampullary"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pembrolizumab","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07632235","phase":"1/2","setting":"A Multicenter, Prospective, Randomized, Open-label Phase Ib/II Study of Celecoxib Plus Pembrolizumab and Gemcitabine/Cisplatin Versus Pembrolizumab and Gemcitabine/Cisplatin in Patients With CK5/6-High Unresectable Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma","sponsor":"Shanghai 6th People's Hospital","started":"2026-09-15","startedType":"estimated","enrolled":112,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07669220","kind":"trial","name":"A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Cours","aka":["STAR"],"tldr":"A phase 2 trial of toripalimab in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR/MSS Lower Rectal Adenocarcinoma (STAR Trial) is a phase 2, randomised interventional study registered as NCT07669220 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 76 participants, started 2026-01-01 and due to reach its primary completion in 2028-01-01. Interventions recorded: Short-course Radiotherapy, SCRT; Toripalimab. Conditions listed: Rectal Adenocarcinoma; High-risk Locally Advanced; Short-course Radiotherapy (SCRT); Immunotherapy; FOLFOX. Primary outcome: CCR. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed pMMR/MSS rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07669220","url":"https://clinicaltrials.gov/study/NCT07669220"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07669220","phase":"2","setting":"A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR/MSS Lower Rectal Adenocarcinoma (STAR Trial)","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2026-01-01","startedType":"actual","enrolled":76,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04691804","kind":"trial","name":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Ver","aka":[],"tldr":"A phase 3 trial of Abiraterone acetate, Prednisone in prostate cancer, run by Jiangsu HengRui Medicine Co., Ltd., active and no longer recruiting.","summary":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer is a phase 3 interventional study registered as NCT04691804 by Jiangsu HengRui Medicine Co., Ltd., with 496 participants enrolled, started 2021-03-18 and due to reach its primary completion in 2026-12-31. Interventions recorded: Fuzuloparib , Abiraterone acetate and Prednisone, Fuzuloparib Placebo， Abiraterone acetate and Prednisone. Conditions listed: Metastatic Castration-Resistant Prostate Cancer (mCRPC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04691804","url":"https://clinicaltrials.gov/study/NCT04691804"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["abiraterone","prednisone"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04691804","phase":"3","setting":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2021-03-18","startedType":"actual","enrolled":496,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07579234","kind":"trial","name":"A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing the Efficacy and Safety of F182112 Versus Standard of Care in Patients With Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 3 trial testing F182112 in multiple myeloma, now recruiting.","summary":"A Multicenter, Randomised, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing the Efficacy and Safety of F182112 Versus Standard of Care in Patients With Relapsed or Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT07579234, led by Shandong New Time Pharmaceutical, and recruiting on the registry. Official title: Phase III Clinical Study of F182112 in Patients With Relapsed or Refractory Multiple Myeloma. Planned enrolment is 261 participants (estimated). The study started in 2026-01-25 and primary completion is expected in 2029-01-25. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07579234","url":"https://clinicaltrials.gov/study/NCT07579234"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["f182112"],"companies":["shandong-new-time-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07579234","phase":"3","setting":"Phase III Clinical Study of F182112 in Patients With Relapsed or Refractory Multiple Myeloma","sponsor":"Shandong New Time Pharmaceutical","started":"2026-01-25","startedType":"actual","enrolled":261,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06936644","kind":"trial","name":"A Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Fulzerasib (IBI351) in Combination With Ivonescimab (AK-112) in First-line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer Patients With KRAS G12C Mutation","aka":[],"tldr":"A phase 2 trial of Fulzerasib and Ivonescimab in KRAS G12C-mutant non-small-cell lung cancer, run by Shanghai Chest Hospital, not yet recruiting.","summary":"A Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Fulzerasib (IBI351) in Combination With Ivonescimab (AK-112) in First-line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer Patients With KRAS G12C Mutation is a phase 2 interventional study registered as NCT06936644 by Shanghai Chest Hospital, with 39 participants planned, started 2025-04-30 and due to reach its primary completion in 2027-04-30. Interventions recorded: IBI351+AK112. Conditions recorded: KRAS G12C Lung Cancer.\n\nLinked to the drug Fulzerasib because the registry names it among its interventions and KRAS G12C-mutant non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06936644","url":"https://clinicaltrials.gov/study/NCT06936644"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["kras-g12c-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["fulzerasib","ivonescimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06936644","phase":"2","setting":"A Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Fulzerasib (IBI351) in Combination With Ivonescimab (AK-112) in First-line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer Patients With KRAS G12C Mutation","sponsor":"Shanghai Chest Hospital","started":"2025-04-30","startedType":"estimated","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00295763","kind":"trial","name":"A New Study to Follow-up Thyroid Cancer Patients Who Participated in a Previous Study, Which Compared the Success of Destruction of the Thyroid Remnant Using Standard Treatment or Thyrogen","aka":["THYR-008"],"tldr":"A phase 3 trial of Thyrotropin alfa in Thyroid cancer, run by Genzyme, a Sanofi Company, completed.","summary":"A New Study to Follow-up Thyroid Cancer Patients Who Participated in a Previous Study, Which Compared the Success of Destruction of the Thyroid Remnant Using Standard Treatment or Thyrogen is a phase 3 interventional study registered as NCT00295763 by Genzyme, a Sanofi Company, with 61 participants recorded, started 2006-05 and reaching its primary completion in 2006-07. Interventions recorded: Thyrogen (thyrotropin alfa for injection). Conditions recorded: Differentiated Thyroid Cancer.\n\nLinked to the drug Thyrotropin alfa because the registry names it among its interventions and Thyroid cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00295763","url":"https://clinicaltrials.gov/study/NCT00295763"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["thyroid"],"sections":[],"technologies":[],"targets":[],"drugs":["thyrotropin-alfa"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00295763","phase":"3","setting":"Follow-up of Thyroid Cancer Patients From Study THYR-008-00 Who Received Thyroid Remnant Ablation Using Either the Hypothyroid or the Thyrogen Method.","sponsor":"Genzyme, a Sanofi Company","started":"2006-05","enrolled":61,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04669171","kind":"trial","name":"A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma","aka":["SIDNEY"],"tldr":"A phase 1/2 trial of Lenalidomide, Rituximab in follicular lymphoma, run by Enterome, now recruiting.","summary":"A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma is a phase 1/2 interventional study registered as NCT04669171 by Enterome, with 80 participants planned, started 2021-07-05 and due to reach its primary completion in 2029-05-30. Interventions recorded: EO2463, lenalidomide, rituximab. Conditions listed: Follicular Lymphoma, Marginal Zone Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04669171","url":"https://clinicaltrials.gov/study/NCT04669171"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["lenalidomide","rituximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04669171","phase":"1/2","setting":"A Global Multicenter Phase 1/2 Trial of EO2463, a Novel Microbial-Derived Peptide Therapeutic Vaccine, as Monotherapy, and in Combination With Lenalidomide and Rituximab, for Treatment of Patients With Indolent Non-Hodgkin's Lymphoma","sponsor":"Enterome","started":"2021-07-05","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07736612","kind":"trial","name":"A Pan-RAS Inhibitor in Combination With Anti-Tumor Therapy in Participants With Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of nimotuzumab, HS-20093 and adebrelimab in pancreatic cancer, run by Zhejiang University, not yet recruiting.","summary":"A Pan-RAS Inhibitor in Combination With Anti-Tumor Therapy in Participants With Advanced Pancreatic Cancer is a phase 1/2, interventional study registered as NCT07736612 by Zhejiang University, with a registry enrolment figure of 80 participants, started 2026-08-15 and due to reach its primary completion in 2028-08-30. Interventions recorded: HRS-2329 Tablet; Nimotuzumab; HS-20093; Adebrelimab. Conditions listed: Pancreatic Cancer; RAS Mutations or Amplifications. Primary outcome: Objective Response Rate. Pancreatic eligibility wording from the registry: \"* Histopathologically confirmed locally advanced or metastatic pancreatic adenocarcinoma (originating from pancreatic ductal epithelium) that is not amenable to curative therapy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07736612","url":"https://clinicaltrials.gov/study/NCT07736612"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nimotuzumab","hs-20093","adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07736612","phase":"1/2","setting":"A Phase Ib/II Study of the Safety, Tolerability, and Efficacy of a Pan-RAS Inhibitor in Combination With Anti-Tumor Therapy in Participants With Advanced Pancreatic Cancer","sponsor":"Zhejiang University","started":"2026-08-15","startedType":"estimated","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07636785","kind":"trial","name":"A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors","aka":["SPKTAHC"],"tldr":"A phase 1/2 trial of VMD-102 in hepatocellular carcinoma, uveal melanoma, renal cell carcinoma, non-small-cell lung cancer and colorectal cancer, run by VM Discovery, Inc., now recruiting.","summary":"A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors is a phase 1/2 interventional study registered as NCT07636785 by VM Discovery, Inc., with 111 participants planned, started 2026-07-16 and due to reach its primary completion in 2031-05. Interventions recorded: VMD-102.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07636785","url":"https://clinicaltrials.gov/study/NCT07636785"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","uveal-melanoma","rcc","nsclc","colorectal","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07636785","phase":"1/2","setting":"A Phase 1 and 2 First-in-human, Open-label, Multicenter Study to Assess the Safety, Tolerability and Preliminary Efficacy of VMD-102 in Participants With Hepatocellular Carcinoma and Other Advanced Solid Tumors","sponsor":"VM Discovery, Inc.","started":"2026-07-16","startedType":"actual","enrolled":111,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07157033","kind":"trial","name":"A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment in Patients With Locally Advanced Pancreatic Cancer.","aka":[],"tldr":"A phase 1/2 trial of XER-001 in pancreatic ductal adenocarcinoma, run by Xerient Pharma, now recruiting.","summary":"A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment in Patients With Locally Advanced Pancreatic Cancer. is a phase 1/2 interventional study registered as NCT07157033 by Xerient Pharma, with 36 participants planned, started 2026-01-01 and due to reach its primary completion in 2029-07-31. Interventions recorded: XER-001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07157033","url":"https://clinicaltrials.gov/study/NCT07157033"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["amifostine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07157033","phase":"1/2","setting":"A Phase 1/2a, Open Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of XER-001 (Amifostibe for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment of Locally-Advanced Pancreatic Adenocarcinoma","sponsor":"Xerient Pharma","started":"2026-01-01","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05593094","kind":"trial","name":"A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced So","aka":[],"tldr":"A phase 1/2 trial of RO7771950, Pertuzumab in her2-positive breast cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05593094 by Hoffmann-La Roche, with 210 participants planned, started 2020-09-03 and due to reach its primary completion in 2027-08-31. Interventions recorded: ZN-A-1041, ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b, ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b, ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1b, ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1c. Conditions listed: Advanced Solid Tumors, HER2-positive Breast Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05593094","url":"https://clinicaltrials.gov/study/NCT05593094"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["ro7771950","pertuzumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05593094","phase":"1/2","setting":"A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients With HER2-Positive Advanced Solid Tumors","sponsor":"Hoffmann-La Roche","started":"2020-09-03","startedType":"actual","enrolled":210,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04478279","kind":"trial","name":"A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Temozolomide in melanoma and prostate cancer, run by Sapience Therapeutics, active and no longer recruiting.","summary":"A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT04478279 by Sapience Therapeutics, with 125 participants enrolled, started 2020-07-01 and due to reach its primary completion in 2026-12. Interventions recorded: ST101, Temozolomide, Radiation. Conditions listed: Glioblastoma, Melanoma Stage IV, Breast Cancer, Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04478279","url":"https://clinicaltrials.gov/study/NCT04478279"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","prostate","brain-tumours"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04478279","phase":"1/2","setting":"A Phase 1-2 Dose-escalation and Expansion Study of ST101 in Patients With Advanced Unresectable and Metastatic Solid Tumors","sponsor":"Sapience Therapeutics","started":"2020-07-01","startedType":"actual","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06163430","kind":"trial","name":"A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)","aka":["CARDINAL"],"tldr":"A phase 1/2 trial of TERN-701 in chronic myeloid leukaemia, run by Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), now recruiting.","summary":"A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL) is a phase 1/2 interventional study registered as NCT06163430 by Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), with 180 participants planned, started 2024-03-26 and due to reach its primary completion in 2029-11-30. Interventions recorded: TERN-701.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06163430","url":"https://clinicaltrials.gov/study/NCT06163430"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cml"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06163430","phase":"1/2","setting":"A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia","sponsor":"Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)","started":"2024-03-26","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06956690","kind":"trial","name":"A Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With HER3-Expressing ","aka":[],"tldr":"A phase 1/2 trial of ENV-501 in melanoma and non-small-cell lung cancer, run by Hummingbird Bioscience, now recruiting.","summary":"A Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With HER3-Expressing Solid Tumors is a phase 1/2 interventional study registered as NCT06956690 by Hummingbird Bioscience, with 180 participants planned, started 2025-12-17 and due to reach its primary completion in 2027-07. Interventions recorded: ENV-501. Conditions listed: Melanoma (Skin), Non Small Cell Lung Cancer, Breast Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06956690","url":"https://clinicaltrials.gov/study/NCT06956690"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["env-501"],"companies":["hummingbird-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06956690","phase":"1/2","setting":"A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing Solid Tumors","sponsor":"Hummingbird Bioscience","started":"2025-12-17","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05547061","kind":"trial","name":"A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Anti-tumor Activity of Ga-68-NGUL / Lu-177-DGUL in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Refractory to Standard Therapy","aka":[],"tldr":"A phase 1/2 trial of Lu-177-DGUL in prostate cancer, run by Cellbion Co., Ltd., active and no longer recruiting.","summary":"A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Anti-tumor Activity of Ga-68-NGUL / Lu-177-DGUL in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Refractory to Standard Therapy is a phase 1/2 interventional study registered as NCT05547061 by Cellbion Co., Ltd., with 91 participants enrolled, started 2021-04-12 and due to reach its primary completion in 2024-12-31. Interventions recorded: Lu-177-DGUL and Ga-68-NGUL.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05547061","url":"https://clinicaltrials.gov/study/NCT05547061"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["lu177-radioligand-therapy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05547061","phase":"1/2","setting":"A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Anti-tumor Activity of Ga-68-NGUL / Lu-177-DGUL in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Refractory to Standard Therapy","sponsor":"Cellbion Co., Ltd.","started":"2021-04-12","startedType":"actual","enrolled":91,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06383052","kind":"trial","name":"A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC","aka":[],"tldr":"A phase 1/2 trial of 177Lu-NYM032 injection in prostate cancer, run by Norroy Bioscience Co., LTD, active and no longer recruiting.","summary":"A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC is a phase 1/2 interventional study registered as NCT06383052 by Norroy Bioscience Co., LTD, with 30 participants enrolled, started 2024-04-26 and due to reach its primary completion in 2025-06-30. Interventions recorded: 177Lu-NYM032 injection.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06383052","url":"https://clinicaltrials.gov/study/NCT06383052"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":["psma"],"drugs":[],"companies":["norroy-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06383052","phase":"1/2","setting":"A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Radiation Dosimetry and Efficacy of 177Lu-NYM032 Injection in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer","sponsor":"Norroy Bioscience Co., LTD","started":"2024-04-26","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05180799","kind":"trial","name":"A Phase 1/2 Study of BA3071 in Patients With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of BA3071, Nivolumab, Pembrolizumab in melanoma, run by BioAtla, Inc., active and no longer recruiting.","summary":"A Phase 1/2 Study of BA3071 in Patients With Solid Tumors is a phase 1/2 interventional study registered as NCT05180799 by BioAtla, Inc., with 320 participants planned, started 2022-08-03 and due to reach its primary completion in 2025-03-19. Interventions recorded: BA3071, Nivolumab, Pembrolizumab, Pemetrexed (Alimta). Conditions listed: NSCLC, Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05180799","url":"https://clinicaltrials.gov/study/NCT05180799"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["ba3071","nivolumab","pembrolizumab","pemetrexed"],"companies":["bioatla"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05180799","phase":"1/2","setting":"A Phase 1/2 Study of BA3071 in Patients With Solid Tumors","sponsor":"BioAtla, Inc.","started":"2022-08-03","startedType":"actual","enrolled":320,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06427941","kind":"trial","name":"A Phase 1/2 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Sol","aka":[],"tldr":"A phase 1/2 trial of Tislelizumab, Bevacizumab in hepatocellular carcinoma and non-small-cell lung cancer, run by BeOne Medicines, now recruiting.","summary":"A Phase 1/2 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06427941 by BeOne Medicines, with 630 participants planned, started 2024-07-23 and due to reach its primary completion in 2027-03-31. Interventions recorded: BGB-B2033, Tislelizumab, Bevacizumab. Conditions listed: Metastatic Hepatocellular Carcinoma, Local Advanced Hepatocellular Carcinoma, Alpha-fetoprotein (AFP)-Producing Gastric Cancer, Extragonadal Yolk Sac Tumors. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06427941","url":"https://clinicaltrials.gov/study/NCT06427941"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","nsclc","sclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["tislelizumab","bevacizumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06427941","phase":"1/2","setting":"A Phase 1/2 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Selected Advanced or Metastatic Solid Tumors","sponsor":"BeOne Medicines","started":"2024-07-23","startedType":"actual","enrolled":630,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06384807","kind":"trial","name":"A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Cemiplimab in advanced solid tumours, run by Biohaven Therapeutics Ltd., now recruiting.","summary":"A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06384807 by Biohaven Therapeutics Ltd., with 500 participants planned, started 2024-04-22 and due to reach its primary completion in 2028-02. Interventions recorded: BHV-1510 and Cemiplimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06384807","url":"https://clinicaltrials.gov/study/NCT06384807"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06384807","phase":"1/2","setting":"A Phase 1/2, First in Human, Dose Escalation and Dose Expansion Study of BHV-1510 (Previously PBI-410) as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Tumors","sponsor":"Biohaven Therapeutics Ltd.","started":"2024-04-22","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05886920","kind":"trial","name":"A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations","aka":[],"tldr":"A phase 1/2 trial of D3S-002 in advanced solid tumours, run by D3 Bio (Wuxi) Co., Ltd, now recruiting.","summary":"A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations is a phase 1/2 interventional study registered as NCT05886920 by D3 Bio (Wuxi) Co., Ltd, with 67 participants planned, started 2023-07-10 and due to reach its primary completion in 2028-08. Interventions recorded: D3S-002 and D3S-001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05886920","url":"https://clinicaltrials.gov/study/NCT05886920"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["d3-bio-wuxi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05886920","phase":"1/2","setting":"A Phase 1/2, Open Label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose of D3S-002 Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations","sponsor":"D3 Bio (Wuxi) Co., Ltd","started":"2023-07-10","startedType":"actual","enrolled":67,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04988555","kind":"trial","name":"A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)","aka":["Horizen-1"],"tldr":"A phase 1/2 trial of Venetoclax, Gilteritinib, Azacitidine in multiple myeloma, run by Sumitomo Pharma America, Inc., now recruiting.","summary":"A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1) is a phase 1/2 interventional study registered as NCT04988555 by Sumitomo Pharma America, Inc., with 606 participants planned, started 2022-02-28 and due to reach its primary completion in 2027-06-30. Interventions recorded: Enzomenib, azoles, Venetoclax, Gilteritinib, Azacitidine (AZA). Conditions listed: Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Acute, Multiple Myeloma, Myelodysplastic Syndromes. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04988555","url":"https://clinicaltrials.gov/study/NCT04988555"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["venetoclax","gilteritinib","azacitidine"],"companies":["sumitomo-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04988555","phase":"1/2","setting":"A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia and Other Selected Hematologic Malignancies, With and Without Mixed Lineage Leukemia (MLL) Rearrangement or Nucleophosmin 1 (NPM1) Mutation (Horizen-1)","sponsor":"Sumitomo Pharma America, Inc.","started":"2022-02-28","startedType":"actual","enrolled":606,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07328217","kind":"trial","name":"A Phase 1/2 Study of GW5282 in Participants With Advanced Solid Tumors","aka":["BEI-DOU2"],"tldr":"A phase 1/2 trial of GW5282 in advanced solid tumours, run by Dizal Pharmaceuticals, now recruiting.","summary":"A Phase 1/2 Study of GW5282 in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07328217 by Dizal Pharmaceuticals, with 203 participants planned, started 2026-01-29 and due to reach its primary completion in 2028-12. Interventions recorded: GW5282.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07328217","url":"https://clinicaltrials.gov/study/NCT07328217"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07328217","phase":"1/2","setting":"A Phase 1/2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Efficacy of GW5282 in Participants With Advanced Solid Tumors (BEI-DOU2)","sponsor":"Dizal Pharmaceuticals","started":"2026-01-29","startedType":"actual","enrolled":203,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05908409","kind":"trial","name":"A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies","aka":["CASSANDRA"],"tldr":"A phase 1/2 trial of IDP-121 in multiple myeloma, diffuse large B-cell lymphoma, non-Hodgkin lymphoma and chronic lymphocytic leukaemia, run by IDP Discovery Pharma S.L., now recruiting.","summary":"A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies is a phase 1/2 interventional study registered as NCT05908409 by IDP Discovery Pharma S.L., with 37 participants planned, started 2023-06-05 and due to reach its primary completion in 2025-12-22. Interventions recorded: IDP-121.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05908409","url":"https://clinicaltrials.gov/study/NCT05908409"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","dlbcl","non-hodgkin-lymphoma","cll"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05908409","phase":"1/2","setting":"A Phase 1/2 Multicenter, Open-label, Dose-escalation Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies (CASSANDRA)","sponsor":"IDP Discovery Pharma S.L.","started":"2023-06-05","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07629726","kind":"trial","name":"A Phase 1/2 Study of KK2430 in Participants With Hematologic Neoplasms","aka":[],"tldr":"A phase 1/2 trial of KK2430 in advanced solid tumours, run by Kyowa Kirin Co., Ltd., now recruiting.","summary":"A Phase 1/2 Study of KK2430 in Participants With Hematologic Neoplasms is a phase 1/2 interventional study registered as NCT07629726 by Kyowa Kirin Co., Ltd., with 72 participants planned, started 2026-08 and due to reach its primary completion in 2027-04. Interventions recorded: KK2430.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07629726","url":"https://clinicaltrials.gov/study/NCT07629726"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["kyowa-kirin"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07629726","phase":"1/2","setting":"A Phase 1/2, Multicenter, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KK2430 in Participants With Hematologic Neoplasms","sponsor":"Kyowa Kirin Co., Ltd.","started":"2026-08","startedType":"estimated","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06480240","kind":"trial","name":"A Phase 1/2 Study of OBI-992 in Subjects With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of OBI-992 in advanced solid tumours, run by OBI Pharma, Inc, active and no longer recruiting.","summary":"A Phase 1/2 Study of OBI-992 in Subjects With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06480240 by OBI Pharma, Inc, with 117 participants enrolled, started 2024-06-12 and due to reach its primary completion in 2027-06. Interventions recorded: OBI-992.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06480240","url":"https://clinicaltrials.gov/study/NCT06480240"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["obi-992"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06480240","phase":"1/2","setting":"A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-992 in Subjects With Advanced Solid Tumors","sponsor":"OBI Pharma, Inc","started":"2024-06-12","startedType":"actual","enrolled":117,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05463263","kind":"trial","name":"A Phase 1/2 Study of STP938 (Dencatistat) for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas","aka":[],"tldr":"A phase 1/2 trial of STP938 in non-Hodgkin lymphoma, run by Step Pharma, SAS, now recruiting.","summary":"A Phase 1/2 Study of STP938 (Dencatistat) for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas is a phase 1/2 interventional study registered as NCT05463263 by Step Pharma, SAS, with 180 participants planned, started 2022-08-03 and due to reach its primary completion in 2026-12. Interventions recorded: STP938.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05463263","url":"https://clinicaltrials.gov/study/NCT05463263"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["stp938"],"companies":["step-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05463263","phase":"1/2","setting":"An Open-Label, First in Human, Phase 1/2 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the CTPS1 Inhibitor STP938 In Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas","sponsor":"Step Pharma, SAS","started":"2022-08-03","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07185880","kind":"trial","name":"A Phase 1/2 Study of the Safety and Tolerability of MT-125 in GBM Patients","aka":["STAR-GBM"],"tldr":"A phase 1/2 trial of MT-125 in glioma & glioblastoma, run by Myosin Therapeutics Inc., now recruiting.","summary":"A Phase 1/2 Study of the Safety and Tolerability of MT-125 in GBM Patients is a phase 1/2 interventional study registered as NCT07185880 by Myosin Therapeutics Inc., with 36 participants planned, started 2026-04-01 and due to reach its primary completion in 2026-10-31. Interventions recorded: MT-125.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07185880","url":"https://clinicaltrials.gov/study/NCT07185880"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07185880","phase":"1/2","setting":"A Phase 1/2 Single-Arm Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of MT-125 Monotherapy With Radiation in Newly Diagnosed Glioblastoma","sponsor":"Myosin Therapeutics Inc.","started":"2026-04-01","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07491497","kind":"trial","name":"A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC","aka":[],"tldr":"A phase 1/2 trial of TRI-611 in non-small-cell lung cancer and small-cell lung cancer, run by TRIANA Biomedicines, Inc., now recruiting.","summary":"A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC is a phase 1/2 interventional study registered as NCT07491497 by TRIANA Biomedicines, Inc., with 160 participants planned, started 2026-03-11 and due to reach its primary completion in 2029-05-31. Interventions recorded: TRI-611. Conditions listed: ALK-positive NSCLC, ALK-Positive Lung Cancer, ALK-positive Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07491497","url":"https://clinicaltrials.gov/study/NCT07491497"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","alk-positive-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["tri-611"],"companies":["triana-biomedicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07491497","phase":"1/2","setting":"A Phase 1/2, Dose Escalation and Expansion Study of TRI-611, an Oral ALK Molecular Glue Degrader in Participants With Advanced ALK-Positive NSCLC","sponsor":"TRIANA Biomedicines, Inc.","started":"2026-03-11","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07020221","kind":"trial","name":"A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of VS-7375, Cetuximab, Carboplatin in pancreatic ductal adenocarcinoma and non-small-cell lung cancer, run by Verastem, Inc., now recruiting.","summary":"A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors is a phase 1/2 interventional study registered as NCT07020221 by Verastem, Inc., with 295 participants planned, started 2025-06-24 and due to reach its primary completion in 2028-12. Interventions recorded: VS-7375, Cetuximab, Carboplatin + Pemetrexed + Pembrolizumab, Gemcitabine, Gemcitabine + Nab-paclitaxel. Conditions listed: Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer, Colorectal Cancer, Solid Tumor, Adult. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07020221","url":"https://clinicaltrials.gov/study/NCT07020221"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","nsclc","sclc","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["vs-7375","cetuximab","carboplatin","pemetrexed","pembrolizumab","gemcitabine"],"companies":["verastem"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07020221","phase":"1/2","setting":"A Phase 1/2, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients With Advanced KRAS G12D-Mutated Solid Tumors","sponsor":"Verastem, Inc.","started":"2025-06-24","startedType":"actual","enrolled":295,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06055439","kind":"trial","name":"A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy","aka":[],"tldr":"A phase 1/2 trial of CHM-2101 CAR-T cells in neuroendocrine tumours, colorectal cancer and gastric & gastro-oesophageal junction cancer, run by Chimeric Therapeutics, now recruiting.","summary":"A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy is a phase 1/2 interventional study registered as NCT06055439 by Chimeric Therapeutics, with 135 participants planned, started 2024-05-15 and due to reach its primary completion in 2026-05. Interventions recorded: CHM-2101 CAR-T cells.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06055439","url":"https://clinicaltrials.gov/study/NCT06055439"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine","colorectal","gastric"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06055439","phase":"1/2","setting":"A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 (CDH17) Chimeric Antigen Receptor (CAR) T Cell Therapy for the Treatment of Relapsed or Refractory Gastrointestinal Cancers","sponsor":"Chimeric Therapeutics","started":"2024-05-15","startedType":"actual","enrolled":135,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05394831","kind":"trial","name":"A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC","aka":[],"tldr":"A phase 1/2 trial of JIN-A02 in non-small-cell lung cancer, run by J Ints Bio, now recruiting.","summary":"A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC is a phase 1/2 interventional study registered as NCT05394831 by J Ints Bio, with 150 participants planned, started 2023-07-30 and due to reach its primary completion in 2026-09-30. Interventions recorded: JIN-A02.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05394831","url":"https://clinicaltrials.gov/study/NCT05394831"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":["egfr"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05394831","phase":"1/2","setting":"A Phase 1/2, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of JIN-A02 in Patients With EGFR Mutant Advanced Non-small Cell Lung Cancer","sponsor":"J Ints Bio","started":"2023-07-30","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06265727","kind":"trial","name":"A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of CRB-701 in advanced solid tumours, run by Corbus Pharmaceuticals Inc., now recruiting.","summary":"A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors is a phase 1/2 interventional study registered as NCT06265727 by Corbus Pharmaceuticals Inc., with 348 participants planned, started 2024-04-01 and due to reach its primary completion in 2027-01-16. Interventions recorded: CRB-701 and Anti-PD-1.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06265727","url":"https://clinicaltrials.gov/study/NCT06265727"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["crb-701"],"companies":["corbus-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06265727","phase":"1/2","setting":"A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors","sponsor":"Corbus Pharmaceuticals Inc.","started":"2024-04-01","startedType":"actual","enrolled":348,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06480565","kind":"trial","name":"A Phase 1/2 Trial of ADI-270 in ccRCC","aka":[],"tldr":"A phase 1/2 trial of ADI-270, Fludarabine, Cyclophosphamide in renal cell carcinoma, run by Adicet Therapeutics, active and no longer recruiting.","summary":"A Phase 1/2 Trial of ADI-270 in ccRCC is a phase 1/2 interventional study registered as NCT06480565 by Adicet Therapeutics, with 60 participants planned, started 2024-12-12 and due to reach its primary completion in 2026-12. Interventions recorded: ADI-270, Fludarabine, Cyclophosphamide. Conditions listed: Clear Cell Renal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06480565","url":"https://clinicaltrials.gov/study/NCT06480565"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc","clear-cell-rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["adi-270","fludarabine","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06480565","phase":"1/2","setting":"A Phase 1/2 Trial of ADI-270 (Engineered γδ Chimeric Receptor [CAR] Vδ1 T Cells Targeting CD70) in Adults With Relapsed or Refractory (R/R) Clear Cell Renal Cell Carcinoma (ccRCC)","sponsor":"Adicet Therapeutics","started":"2024-12-12","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04036682","kind":"trial","name":"A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer","aka":["REZILIENT1"],"tldr":"A phase 1/2 trial of Zipalertinib in non-small-cell lung cancer and small-cell lung cancer, run by Cullinan Therapeutics Inc., active and no longer recruiting.","summary":"A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT04036682 by Cullinan Therapeutics Inc., with 284 participants planned, started 2019-10-31 and due to reach its primary completion in 2025-10-13. Interventions recorded: CLN-081. Conditions listed: Non Small Cell Lung Cancer, EGFR Exon 20 Mutation. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04036682","url":"https://clinicaltrials.gov/study/NCT04036682"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["zipalertinib"],"companies":["cullinan-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04036682-j-clin-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04036682","phase":"1/2","setting":"A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy","sponsor":"Cullinan Therapeutics Inc.","started":"2019-10-31","startedType":"actual","enrolled":284,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07109726","kind":"trial","name":"A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations","aka":[],"tldr":"A phase 1/2 trial of Fulvestrant in endometrial cancer and ovarian cancer, run by Terremoto Biosciences Inc., now recruiting.","summary":"A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations is a phase 1/2 interventional study registered as NCT07109726 by Terremoto Biosciences Inc., with 205 participants planned, started 2025-09-23 and due to reach its primary completion in 2028-12-30. Interventions recorded: TER-2013, Fulvestrant injection. Conditions listed: Breast Cancer, Endometrial Cancer, Ovarian Cancer, Lung Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07109726","url":"https://clinicaltrials.gov/study/NCT07109726"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial","ovarian","head-and-neck","cervical"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["fulvestrant"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07109726","phase":"1/2","setting":"A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations","sponsor":"Terremoto Biosciences Inc.","started":"2025-09-23","startedType":"actual","enrolled":205,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06725758","kind":"trial","name":"A Phase 1/2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours","aka":["TEADES"],"tldr":"A phase 1/2 trial of ODM-212 in advanced solid tumours, run by Orion Corporation, Orion Pharma, now recruiting.","summary":"A Phase 1/2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours is a phase 1/2 interventional study registered as NCT06725758 by Orion Corporation, Orion Pharma, with 315 participants planned, started 2023-10-26 and due to reach its primary completion in 2027-12-31. Interventions recorded: ODM-212.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06725758","url":"https://clinicaltrials.gov/study/NCT06725758"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["orion-orion-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06725758","phase":"1/2","setting":"A Phase 1/2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours","sponsor":"Orion Corporation, Orion Pharma","started":"2023-10-26","startedType":"actual","enrolled":315,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06616766","kind":"trial","name":"A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946","aka":[],"tldr":"A phase 1/2 trial of YH42946 in non-small-cell lung cancer, run by Yuhan Corporation, now recruiting.","summary":"A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946 is a phase 1/2 interventional study registered as NCT06616766 by Yuhan Corporation, with 201 participants planned, started 2024-10-02 and due to reach its primary completion in 2028-03-15. Interventions recorded: YH42946.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06616766","url":"https://clinicaltrials.gov/study/NCT06616766"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc","her2-mutant-nsclc"],"sections":[],"technologies":[],"targets":["her2","egfr"],"drugs":[],"companies":["yuhan"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06616766","phase":"1/2","setting":"A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, PK and Anti-tumor Activity of YH42946 in Patients With Locally Advanced or Metastatic Solid Tumors With HER2 Aberration and EGFR Exon 20 Insertion","sponsor":"Yuhan Corporation","started":"2024-10-02","startedType":"actual","enrolled":201,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05199272","kind":"trial","name":"A Phase 1/2a Study of 23ME-00610 in Patients With Advanced Solid Malignancies","aka":[],"tldr":"A phase 1/2 trial of 23ME-00610 in renal cell carcinoma, ovarian cancer, neuroendocrine tumours and small-cell lung cancer, run by 23andMe, Inc., active and no longer recruiting.","summary":"A Phase 1/2a Study of 23ME-00610 in Patients With Advanced Solid Malignancies is a phase 1/2 interventional study registered as NCT05199272 by 23andMe, Inc., with 141 participants enrolled, started 2021-12-29 and due to reach its primary completion in 2025-03. Interventions recorded: 23ME-00610.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05199272","url":"https://clinicaltrials.gov/study/NCT05199272"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc","ovarian","neuroendocrine","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05199272-cancer-res-commun-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05199272","phase":"1/2","setting":"A Phase 1/2a, Multicenter, Open-Label, Dose-Escalation and Expansion Study of Intravenously Administered 23ME-00610 in Patients With Advanced Solid Malignancies","sponsor":"23andMe, Inc.","started":"2021-12-29","startedType":"actual","enrolled":141,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05150691","kind":"trial","name":"A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Trastuzumab pamirtecan and Pertuzumab in advanced solid tumours, run by DualityBio Inc., now recruiting.","summary":"A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05150691 by DualityBio Inc., with 796 participants planned, started 2022-01-31 and due to reach its primary completion in 2027-08. Interventions recorded: DB-1303/BNT323, Pertuzumab Injection, Ritonavir and Itraconazole.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05150691","url":"https://clinicaltrials.gov/study/NCT05150691"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-pamirtecan","pertuzumab"],"companies":["dualitybio","biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05150691","phase":"1/2","setting":"A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303/BNT323 in Patients With Advanced/Metastatic Solid Tumors","sponsor":"DualityBio Inc.","started":"2022-01-31","startedType":"actual","enrolled":796,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05914116","kind":"trial","name":"A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of BNT324 and Enzalutamide in advanced solid tumours, run by DualityBio Inc., now recruiting.","summary":"A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05914116 by DualityBio Inc., with 862 participants planned, started 2023-08-17 and due to reach its primary completion in 2027-12. Interventions recorded: DB-1311, Lopinavir and Ritonavir Tablets, itraconazole, Enzalutamide and Abiraterone.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05914116","url":"https://clinicaltrials.gov/study/NCT05914116"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["bnt324","enzalutamide"],"companies":["dualitybio","biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05914116","phase":"1/2","setting":"A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects With Advanced/Metastatic Solid Tumors","sponsor":"DualityBio Inc.","started":"2023-08-17","startedType":"actual","enrolled":862,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05585320","kind":"trial","name":"A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Paclitaxel / nab-paclitaxel, Dabrafenib, Pembrolizumab in melanoma and non-small-cell lung cancer, run by Immuneering Corporation, active and no longer recruiting.","summary":"A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05585320 by Immuneering Corporation, with 209 participants enrolled, started 2022-10-31 and due to reach its primary completion in 2026-06. Interventions recorded: IMM-1-104 Monotherapy (Treatment Group A), IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B), IMM-1-104 + modified FOLFIRINOX (Treatment Group C), IMM-1-104 + dabrafenib (Treatment Group D), IMM-1-104 + pembrolizumab (Treatment Group E). Conditions listed: Advanced Solid Tumor, Pancreatic Adenocarcinoma, Malignant Melanoma (Cutaneous), Non-small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05585320","url":"https://clinicaltrials.gov/study/NCT05585320"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["paclitaxel","dabrafenib","pembrolizumab"],"companies":["immuneering"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05585320","phase":"1/2","setting":"A Phase 1/2a, Open-Label, Multicenter, Nonrandomized, Safety and Anti-tumor Activity Study of IMM-1-104, a Novel Oral Dual MEK1/2 Inhibitor in Participants With Advanced or Metastatic Solid Tumors","sponsor":"Immuneering Corporation","started":"2022-10-31","startedType":"actual","enrolled":209,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07160725","kind":"trial","name":"A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of PM8002 in advanced solid tumours, run by Bristol-Myers Squibb, now recruiting.","summary":"A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07160725 by Bristol-Myers Squibb, with 540 participants planned, started 2025-10-15 and due to reach its primary completion in 2028-07-31. Interventions recorded: BMS-986517 and Pumitamig.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07160725","url":"https://clinicaltrials.gov/study/NCT07160725"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07160725","phase":"1/2","setting":"A Phase 1/2a, First-in-human, Open-label Study of BMS-986517 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors","sponsor":"Bristol-Myers Squibb","started":"2025-10-15","startedType":"actual","enrolled":540,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05664243","kind":"trial","name":"A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma","aka":[],"tldr":"A phase 1/2 trial of Autologous genetically modified gamma-delta T cells in glioma & glioblastoma, run by In8bio Inc., active and no longer recruiting.","summary":"A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma is a phase 1/2 interventional study registered as NCT05664243 by In8bio Inc., with 4 participants enrolled, started 2023-09-08 and due to reach its primary completion in 2025-12. Interventions recorded: Autologous genetically modified gamma-delta T cells and Allogeneic genetically modified gamma-delta T cells.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05664243","url":"https://clinicaltrials.gov/study/NCT05664243"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05664243","phase":"1/2","setting":"A Phase 1b / 2 Open-label Study to Investigate the Safety, Tolerance and Efficacy of Drug Resistant Immunotherapy (DRI) With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide (TMZ) in Subjects With Recurrent or Newly Diagnosed Glioblastoma","sponsor":"In8bio Inc.","started":"2023-09-08","startedType":"actual","enrolled":4,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06939283","kind":"trial","name":"A Phase 1b/2 Multisite Dose-finding and Expansion Study of WTX-330 in Adult Patients With Selected Advanced or Metastatic Solid Tumors or Lymphoma","aka":[],"tldr":"A phase 1/2 trial of WTX-330 in non-Hodgkin lymphoma, run by Werewolf Therapeutics, Inc., active and no longer recruiting.","summary":"A Phase 1b/2 Multisite Dose-finding and Expansion Study of WTX-330 in Adult Patients With Selected Advanced or Metastatic Solid Tumors or Lymphoma is a phase 1/2 interventional study registered as NCT06939283 by Werewolf Therapeutics, Inc., with 100 participants enrolled, started 2025-05-07 and due to reach its primary completion in 2028-08. Interventions recorded: WTX-330.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06939283","url":"https://clinicaltrials.gov/study/NCT06939283"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["werewolf-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06939283","phase":"1/2","setting":"A Phase 1b/2 Multisite Dose- and Regimen-finding and Expansion Study of WTX-330 in Adult Patients With Selected Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma (NHL)","sponsor":"Werewolf Therapeutics, Inc.","started":"2025-05-07","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04973605","kind":"trial","name":"A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Darat","aka":[],"tldr":"A phase 1/2 trial of Sonrotoclax, Dexamethasone, Carfilzomib in multiple myeloma, run by BeOne Medicines, now recruiting.","summary":"A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma is a phase 1/2 interventional study registered as NCT04973605 by BeOne Medicines, with 246 participants planned, started 2021-09-16 and due to reach its primary completion in 2026-11. Interventions recorded: Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide. Conditions listed: Relapsed/Refractory Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04973605","url":"https://clinicaltrials.gov/study/NCT04973605"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","bcl2-inhibitors","kinase-inhibitors","monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["sonrotoclax","dexamethasone","carfilzomib","daratumumab","pomalidomide"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04973605","phase":"1/2","setting":"A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study to Determine the Safety and Efficacy of BGB-11417as Monotherapy, in Combination With Dexamethasone, Dexamethasone/Carfilzomib, Dexamethasone/Daratumumab, and Dexamethasone/Pomalidomide in Patients With Relapsed/Refractory Multiple Myeloma and t(11;14)","sponsor":"BeOne Medicines","started":"2021-09-16","startedType":"actual","enrolled":246,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04538742","kind":"trial","name":"A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer","aka":["DESTINY-Breast07"],"tldr":"A phase 1/2 trial of Trastuzumab deruxtecan, Durvalumab, Pertuzumab and Tucatinib in HER2-positive breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer is a phase 1/2 interventional study registered as NCT04538742 by AstraZeneca, with 245 participants enrolled, started 2020-12-28 and due to reach its primary completion in 2025-01-31. Interventions recorded: Trastuzumab deruxtecan, Durvalumab, Paclitaxel, Pertuzumab and Tucatinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04538742","url":"https://clinicaltrials.gov/study/NCT04538742"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan","durvalumab","pertuzumab","tucatinib"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04538742","phase":"1/2","setting":"A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07)","sponsor":"AstraZeneca","started":"2020-12-28","startedType":"actual","enrolled":245,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02586857","kind":"trial","name":"A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)","aka":[],"tldr":"A phase 1/2 trial of ACP-196 in glioma & glioblastoma, run by Acerta Pharma BV, active and no longer recruiting.","summary":"A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM) is a phase 1/2 interventional study registered as NCT02586857 by Acerta Pharma BV, with 24 participants enrolled, started 2016-01-25 and due to reach its primary completion in 2020-06-26. Interventions recorded: ACP-196. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02586857","url":"https://clinicaltrials.gov/study/NCT02586857"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02586857","phase":"1/2","setting":"A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)","sponsor":"Acerta Pharma BV","started":"2016-01-25","startedType":"actual","yearReported":2020,"enrolled":24,"enrolledBasis":"registry","outcomes":[{"endpoint":"Assessment of Tumor Status for Overall Response Rate With Use of RANO Criteria.","primary":true,"unit":"participants","arms":[{"name":"Cohort 1","n":15,"value":1,"note":"Figures from the ClinicalTrials.gov results section (first posted 2020-07-29), not from a publication"},{"name":"Cohort 2","n":9,"value":1}],"source":"https://clinicaltrials.gov/study/NCT02586857?tab=results"}]},{"id":"nct06785636","kind":"trial","name":"A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC","aka":[],"tldr":"A phase 1/2 trial of Darolutamide in prostate cancer, run by Pathos AI, Inc., now recruiting.","summary":"A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC is a phase 1/2 interventional study registered as NCT06785636 by Pathos AI, Inc., with 120 participants planned, started 2025-02-07 and due to reach its primary completion in 2028-06-30. Interventions recorded: Pocenbrodib, Pocenbrodib and Darolutamide. Conditions listed: mCRPC (Metastatic Castration-resistant Prostate Cancer), Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06785636","url":"https://clinicaltrials.gov/study/NCT06785636"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["darolutamide"],"companies":["pathos-ai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06785636","phase":"1/2","setting":"PATHWAY: A Phase 1b/2a, Multicenter, Open- Label Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","sponsor":"Pathos AI, Inc.","started":"2025-02-07","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07766018","kind":"trial","name":"A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer","aka":[],"tldr":"A phase 2 trial of Elacestrant in advanced solid tumours, run by Stemline Therapeutics, Inc., now recruiting.","summary":"A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer is a phase 2 interventional study registered as NCT07766018 by Stemline Therapeutics, Inc., with 70 participants planned, started 2026-08-18 and due to reach its primary completion in 2028-10. Interventions recorded: Elacestrant.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07766018","url":"https://clinicaltrials.gov/study/NCT07766018"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["elacestrant"],"companies":["menarini"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07766018","phase":"2","setting":"A Phase 2 Open-Label, Single-Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Elacestrant Monotherapy for the Treatment of Japanese Participants With ER+/HER2- Advanced or Metastatic Breast Cancer With ESR1-mutation Following CDK4/6 Inhibitor Therapy","sponsor":"Stemline Therapeutics, Inc.","started":"2026-08-18","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06632262","kind":"trial","name":"A Phase 2 Clinical Study of ABSK061 and ABSK043","aka":[],"tldr":"A phase 2 trial of ABSK061, CAPOX in non-small-cell lung cancer and small-cell lung cancer, run by Abbisko Therapeutics Co, Ltd, now recruiting.","summary":"A Phase 2 Clinical Study of ABSK061 and ABSK043 is a phase 2 interventional study registered as NCT06632262 by Abbisko Therapeutics Co, Ltd, with 202 participants planned, started 2024-11-13 and due to reach its primary completion in 2029-11-30. Interventions recorded: ABSK061 + ABSK043, ABSK061+ABSK043 in combination with CAPOX. Conditions listed: HER2-Gastric/Gastroesophageal Junction Cancer, Urothelial Carcinoma, Non-Small Cell Lung Cancer, Solid Tumors. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06632262","url":"https://clinicaltrials.gov/study/NCT06632262"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["absk061","capox"],"companies":["abbisko"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06632262","phase":"2","setting":"An Open-label Phase 2, Multicenter, Open-Label Clinical Study to Evaluate the Safety and Efficacy of ABSK061 and ABSK043 with or Without Chemotherapy in Patients with Metastatic/Unresectable Solid Tumors with FGFR2/3 Alterations","sponsor":"Abbisko Therapeutics Co, Ltd","started":"2024-11-13","startedType":"actual","enrolled":202,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06668103","kind":"trial","name":"A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib","aka":[],"tldr":"A phase 2 trial of ABSK043 in combination with Firmonertinib in non-small-cell lung cancer, run by Abbisko Therapeutics Co, Ltd, now recruiting.","summary":"A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib is a phase 2 interventional study registered as NCT06668103 by Abbisko Therapeutics Co, Ltd, with 54 participants planned, started 2024-11-25 and due to reach its primary completion in 2027-12-30. Interventions recorded: ABSK043 in combination with Firmonertinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06668103","url":"https://clinicaltrials.gov/study/NCT06668103"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["abbisko"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06668103","phase":"2","setting":"A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of ABSK043 Combined With Firmonertinib in Patients With EGFR Mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer(NSCLC)","sponsor":"Abbisko Therapeutics Co, Ltd","started":"2024-11-25","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07164170","kind":"trial","name":"A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib","aka":[],"tldr":"A phase 2 trial of Glecirasib in non-small-cell lung cancer and small-cell lung cancer, run by Abbisko Therapeutics Co, Ltd, now recruiting.","summary":"A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib is a phase 2 interventional study registered as NCT07164170 by Abbisko Therapeutics Co, Ltd, with 86 participants planned, started 2025-09-22 and due to reach its primary completion in 2028-12-30. Interventions recorded: ABSK043 in combination with Glecirasib. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07164170","url":"https://clinicaltrials.gov/study/NCT07164170"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","kras-g12c-nsclc"],"sections":[],"technologies":["kinase-inhibitors","kras-inhibitors"],"targets":[],"drugs":["glecirasib"],"companies":["abbisko"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07164170","phase":"2","setting":"An Open-label Phase II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of ABSK043 in Combination With Glecirasib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring a KRAS G12C Mutation","sponsor":"Abbisko Therapeutics Co, Ltd","started":"2025-09-22","startedType":"actual","enrolled":86,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04379167","kind":"trial","name":"A Phase 2 Clinical Study of YY-20394 in Patients With Relapsed/Refractory Follicular Lymphoma","aka":[],"tldr":"A phase 2 trial of Linperlisib in Follicular lymphoma, run by Shanghai YingLi Pharmaceutical Co. Ltd., with a status the registry has not verified recently.","summary":"A Phase 2 Clinical Study of YY-20394 in Patients With Relapsed/Refractory Follicular Lymphoma is a phase 2 interventional study registered as NCT04379167 by Shanghai YingLi Pharmaceutical Co. Ltd., with 140 participants planned, started 2020-12-30 and due to reach its primary completion in 2022-12-30. Interventions recorded: YY-20394. Conditions recorded: Follicular Lymphoma.\n\nLinked to the drug Linperlisib because the registry names it among its interventions and Follicular lymphoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04379167","url":"https://clinicaltrials.gov/study/NCT04379167"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["linperlisib"],"companies":["shanghai-yingli"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04379167","phase":"2","setting":"A Phase 2, Single Arm, Open Label Clinical Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of YY-20394 in Patients With Relapsed/Refractory Follicular Non-Hodgkin's Lymphoma Who Have Failed at Least Two Prior Systemic Therapies.","sponsor":"Shanghai YingLi Pharmaceutical Co. Ltd.","started":"2020-12-30","startedType":"estimated","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07623616","kind":"trial","name":"A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia","aka":[],"tldr":"A phase 2 trial of Ziftomenib in acute myeloid leukaemia, run by Kyowa Kirin Co., Ltd., now recruiting.","summary":"A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia is a phase 2 interventional study registered as NCT07623616 by Kyowa Kirin Co., Ltd., with 6 participants planned, started 2026-04-23 and due to reach its primary completion in 2027-03. Interventions recorded: ziftomenib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07623616","url":"https://clinicaltrials.gov/study/NCT07623616"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-npm1-kmt2a"],"sections":[],"technologies":["epigenetic-drugs"],"targets":[],"drugs":["ziftomenib"],"companies":["kyowa-kirin"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07623616","phase":"2","setting":"A Phase 2, Multicenter, Open-Label Study of Ziftomenib Monotherapy in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia With NPM1 Mutation","sponsor":"Kyowa Kirin Co., Ltd.","started":"2026-04-23","startedType":"actual","enrolled":6,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07102381","kind":"trial","name":"A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer","aka":["EmpowHER 208"],"tldr":"A phase 2 trial of Zanidatamab, Paclitaxel / nab-paclitaxel, Docetaxel in her2-positive breast cancer, run by Jazz Pharmaceuticals, now recruiting.","summary":"A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer is a phase 2 interventional study registered as NCT07102381 by Jazz Pharmaceuticals, with 125 participants planned, started 2025-09-24 and due to reach its primary completion in 2028-01-01. Interventions recorded: Zanidatamab, Paclitaxel, Docetaxel, Carboplatin, Trastuzumab. Conditions listed: HER2-positive Breast Cancer, Breast Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07102381","url":"https://clinicaltrials.gov/study/NCT07102381"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["bispecific-antibody"],"targets":[],"drugs":["zanidatamab","paclitaxel","docetaxel","carboplatin","trastuzumab","pertuzumab"],"companies":["jazz"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07102381","phase":"2","setting":"A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer","sponsor":"Jazz Pharmaceuticals","started":"2025-09-24","startedType":"actual","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07133425","kind":"trial","name":"A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial in lung cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer is a phase 2, interventional study registered as NCT07133425 by M.D. Anderson Cancer Center, with a registry enrolment figure of 29 participants, started 2025-11-06 and due to reach its primary completion in 2028-02-01. Interventions recorded: SAR445877. Conditions listed: Non-Small Cell Lung Cancer; ICI-refractory. Primary outcome: Safety and adverse events (AEs). Lung eligibility wording from the registry: \"Participants with histologically documented locally advanced or metastatic NSCLC who have had disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment:\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07133425","url":"https://clinicaltrials.gov/study/NCT07133425"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07133425","phase":"2","setting":"A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer","sponsor":"M.D. Anderson Cancer Center","started":"2025-11-06","startedType":"actual","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06885385","kind":"trial","name":"A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Shanghai Junshi Bioscience Co., Ltd., now recruiting.","summary":"A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer is a phase 2, interventional study registered as NCT06885385 by Shanghai Junshi Bioscience Co., Ltd., with a registry enrolment figure of 60 participants, started 2025-04-23 and due to reach its primary completion in 2026-11-27. Interventions recorded: JS207; JS015; Capecitabine; Oxaliplatin. Conditions listed: Advanced Colorectal Cancer. Primary outcome: Dose-limiting toxicity （DLT); Adverse event（AE）; RP3D. Colorectal eligibility wording from the registry: \"Colorectal adenocarcinoma or rectal adenocarcinoma with histological or cytological Qualification, according to the 8th edition of the AJCC colorectal cancer TNM staging stage IV, MSS/pMMR (a qualified report of MSS or pMMR detected by a local laboratory must be provided), and no previous systemic a\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06885385","url":"https://clinicaltrials.gov/study/NCT06885385"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":["junshi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06885385","phase":"2","setting":"An Open-label, Multicenter, Phase 2 Clinical Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy (XELOX) as First-line (1L) Treatment in Patients With MSS/pMMR Advanced Colorectal Cance","sponsor":"Shanghai Junshi Bioscience Co., Ltd.","started":"2025-04-23","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06111274","kind":"trial","name":"A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of Pimicotinib (ABSK021) in pancreatic ductal adenocarcinoma, run by Abbisko Therapeutics Co, Ltd, now recruiting.","summary":"A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer is a phase 2 interventional study registered as NCT06111274 by Abbisko Therapeutics Co, Ltd, with 82 participants planned, started 2023-10-17 and due to reach its primary completion in 2025-12-30. Interventions recorded: Pimicotinib (ABSK021).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06111274","url":"https://clinicaltrials.gov/study/NCT06111274"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["abbisko"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06111274","phase":"2","setting":"A Multicenter, Open-Label Phase II Study To Evaluate The Efficacy And Safety Of ABSK021 In Combination With Chemotherapy With Or Without Toripalimab In Patients With Advanced Pancreatic Cancer","sponsor":"Abbisko Therapeutics Co, Ltd","started":"2023-10-17","startedType":"actual","enrolled":82,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07710612","kind":"trial","name":"A Phase 2 Study of ABSK043 Combined With Osimertinib","aka":[],"tldr":"A phase 2 trial of osimertinib in lung cancer, run by Abbisko Therapeutics Co, Ltd, not yet recruiting.","summary":"A Phase 2 Study of ABSK043 Combined With Osimertinib is a phase 2, interventional study registered as NCT07710612 by Abbisko Therapeutics Co, Ltd, with a registry enrolment figure of 72 participants, started 2026-08-31 and due to reach its primary completion in 2029-12-31. Interventions recorded: ABSK043 in combination with Osimertinib. Conditions listed: Non-Small Cell Lung Cancer With EGFR-mutated and PD-L1 Positive. Primary outcome: - Incidence of dose-limiting toxicity (DLT); Adverse events(AEs); Serious adverse events (SAEs). Lung eligibility wording from the registry: \"NSCLC with a mixed histology is eligible, if adenocarcinoma is the predominant histology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07710612","url":"https://clinicaltrials.gov/study/NCT07710612"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":["abbisko","astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07710612","phase":"2","setting":"A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of ABSK043 Combined With Osimertinib in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Abbisko Therapeutics Co, Ltd","started":"2026-08-31","startedType":"estimated","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05548296","kind":"trial","name":"A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma","aka":[],"tldr":"A phase 2 trial of Gemcitabine in endometrial cancer, run by Acrivon Therapeutics, now recruiting.","summary":"A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma is a phase 2 interventional study registered as NCT05548296 by Acrivon Therapeutics, with 350 participants planned, started 2022-08-29 and due to reach its primary completion in 2027-05-30. Interventions recorded: ACR-368 and Gemcitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05548296","url":"https://clinicaltrials.gov/study/NCT05548296"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":["acrivon-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05548296","phase":"2","setting":"A Phase 2 Study of ACR-368 Therapy in Subjects With Endometrial Cancer","sponsor":"Acrivon Therapeutics","started":"2022-08-29","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06593522","kind":"trial","name":"A Phase 2 Study of Anvumetostat in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)","aka":["MTAPESTRY 201"],"tldr":"A phase 2 trial of Anvumetostat in non-small-cell lung cancer, run by Amgen, active and no longer recruiting.","summary":"A Phase 2 Study of Anvumetostat in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201) is a phase 2 interventional study registered as NCT06593522 by Amgen, with 61 participants enrolled, started 2024-12-26 and due to reach its primary completion in 2026-10-31. Interventions recorded: anvumetostat.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06593522","url":"https://clinicaltrials.gov/study/NCT06593522"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["anvumetostat"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06593522","phase":"2","setting":"A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Anvumetostat in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Amgen","started":"2024-12-26","startedType":"actual","enrolled":61,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01975701","kind":"trial","name":"A Phase 2 Study of BGJ398 in Patients With Recurrent GBM","aka":[],"tldr":"A phase 2 trial of Infigratinib in Glioma & glioblastoma, run by Novartis Pharmaceuticals, completed.","summary":"A Phase 2 Study of BGJ398 in Patients With Recurrent GBM is a phase 2 interventional study registered as NCT01975701 by Novartis Pharmaceuticals, with 26 participants recorded, started 2013-12-09 and reaching its primary completion in 2018-10-03. Interventions recorded: BGJ398. Conditions recorded: Recurrent Glioblastoma or Other Glioma Subtypes.\n\nLinked to the drug Infigratinib because the registry names it among its interventions and Glioma & glioblastoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01975701","url":"https://clinicaltrials.gov/study/NCT01975701"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":["infigratinib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01975701","phase":"2","setting":"A Phase 2, Multicenter, Open-label Study of BGJ398 in Patients With Recurrent Resectable or Unresectable Glioblastoma","sponsor":"Novartis Pharmaceuticals","started":"2013-12-09","startedType":"actual","yearReported":2019,"enrolled":26,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival","primary":true,"unit":"months","arms":[{"name":"BGJ398X","n":24,"value":1.7,"note":"95% CI 1.05 to 2.80; Figures from the ClinicalTrials.gov results section (first posted 2019-12-04), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01975701?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"BGJ398X","n":26,"value":6.74,"note":"95% CI 4.17 to 11.73; Figures from the ClinicalTrials.gov results section (first posted 2019-12-04), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01975701?tab=results"}]},{"id":"nct06246110","kind":"trial","name":"A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC","aka":[],"tldr":"A phase 2 trial of EIK1001, Pembrolizumab, Pemetrexed and Carboplatin in non-small-cell lung cancer, run by Eikon Therapeutics, active and no longer recruiting.","summary":"A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC is a phase 2 interventional study registered as NCT06246110 by Eikon Therapeutics, with 70 participants enrolled, started 2024-02-06 and due to reach its primary completion in 2026-12. Interventions recorded: EIK1001, Pembrolizumab, Paclitaxel, Pemetrexed and Carboplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06246110","url":"https://clinicaltrials.gov/study/NCT06246110"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["eik1001","pembrolizumab","pemetrexed","carboplatin"],"companies":["eikon-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06246110","phase":"2","setting":"A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer","sponsor":"Eikon Therapeutics","started":"2024-02-06","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06703255","kind":"trial","name":"A Phase 2 Study of HX301 in Patients with High-grade Giloma","aka":[],"tldr":"A phase 1/2 trial of Temozolomide in glioma & glioblastoma, run by Hangzhou Hanx Biopharmaceuticals, Ltd., now recruiting.","summary":"A Phase 2 Study of HX301 in Patients with High-grade Giloma is a phase 1/2 interventional study registered as NCT06703255 by Hangzhou Hanx Biopharmaceuticals, Ltd., with 72 participants planned, started 2025-01-08 and due to reach its primary completion in 2026-12-31. Interventions recorded: HX301+/Temozolomide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06703255","url":"https://clinicaltrials.gov/study/NCT06703255"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":["hangzhou-hanx-biopharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06703255","phase":"1/2","setting":"A Phase IIa Clinical Study of HX301 Alone or in Combination with Temozolomide in Patients with High-Grade Glioma (Grade III and IV)","sponsor":"Hangzhou Hanx Biopharmaceuticals, Ltd.","started":"2025-01-08","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07562581","kind":"trial","name":"A Phase 2 Study of Luvometinib Combined With Anlotinib in KRAS-mutated NSCLC","aka":[],"tldr":"A phase 2 trial of Anlotinib in non-small-cell lung cancer, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., now recruiting.","summary":"A Phase 2 Study of Luvometinib Combined With Anlotinib in KRAS-mutated NSCLC is a phase 2 interventional study registered as NCT07562581 by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., with 48 participants planned, started 2026-06-15 and due to reach its primary completion in 2029-06. Interventions recorded: luvometinib + anlotinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07562581","url":"https://clinicaltrials.gov/study/NCT07562581"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["anlotinib"],"companies":["shanghai-fosun-pharmaceutical-industrial-development"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07562581","phase":"2","setting":"A Multicenter, Open-label, Single-arm Phase 2 Study to Evaluate the Efficacy and Safety of Luvometinib Combined With Anlotinib in Patients With KRAS-mutated Metastatic Non-small Cell Lung Cancer","sponsor":"Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.","started":"2026-06-15","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07743112","kind":"trial","name":"A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia","aka":[],"tldr":"A phase 2 trial of Azacitidine and Venetoclax in acute myeloid leukaemia, run by Maxinovel Pty., Ltd., now recruiting.","summary":"A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia is a phase 2 interventional study registered as NCT07743112 by Maxinovel Pty., Ltd., with 43 participants planned, started 2025-09-05 and due to reach its primary completion in 2027-09-01. Interventions recorded: MAX-40279, Azacitidine and Venetoclax.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07743112","url":"https://clinicaltrials.gov/study/NCT07743112"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-older-unfit"],"sections":[],"technologies":["bcl2-inhibitors","cytotoxic-chemotherapy","epigenetic-drugs","kinase-inhibitors"],"targets":[],"drugs":["azacitidine","venetoclax"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07743112","phase":"2","setting":"A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia","sponsor":"Maxinovel Pty., Ltd.","started":"2025-09-05","startedType":"actual","enrolled":43,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06568692","kind":"trial","name":"A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer","aka":[],"tldr":"A phase 2 trial of Capecitabine in triple-negative breast cancer, run by Processa Pharmaceuticals, now recruiting.","summary":"A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer is a phase 2 interventional study registered as NCT06568692 by Processa Pharmaceuticals, with 90 participants planned, started 2024-10-02 and due to reach its primary completion in 2026-09. Interventions recorded: PCS6422 and capecitabine and Capecitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06568692","url":"https://clinicaltrials.gov/study/NCT06568692"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06568692","phase":"2","setting":"A Phase 2, Open-Label Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer","sponsor":"Processa Pharmaceuticals","started":"2024-10-02","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06493760","kind":"trial","name":"A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients","aka":[],"tldr":"A phase 2 trial of PF-08634404, Bevacizumab, CAPOX in colorectal cancer, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., now recruiting.","summary":"A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients is a phase 2 interventional study registered as NCT06493760 by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., with 130 participants planned, started 2024-09-03 and due to reach its primary completion in 2025-06. Interventions recorded: SSGJ-707, Bevacizumab, Oxaliplatin, Capecitabine, Calcium Folinate. Conditions listed: Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06493760","url":"https://clinicaltrials.gov/study/NCT06493760"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-08634404","bevacizumab","capox","capecitabine","leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06493760","phase":"2","setting":"A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 As First-Line Treatment in Metastatic Colorectal Cancer Patients","sponsor":"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.","started":"2024-09-03","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05060016","kind":"trial","name":"A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)","aka":["DeLLphi-301"],"tldr":"A phase 2 trial of Tarlatamab in small-cell lung cancer, run by Amgen, active and no longer recruiting.","summary":"A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) is a phase 2 interventional study registered as NCT05060016 by Amgen, with 222 participants enrolled, started 2021-12-01 and due to reach its primary completion in 2027-12-30. Interventions recorded: Tarlatamab. Conditions listed: Relapsed/Refractory Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05060016","url":"https://clinicaltrials.gov/study/NCT05060016"},{"label":"DeLLphi-301 (New England Journal of Medicine 2023)","url":"https://doi.org/10.1056/NEJMoa2307980"},{"label":"NICE TA1091: tarlatamab for extensive-stage small-cell lung cancer after 2 or more treatments (not recommended)","url":"https://www.nice.org.uk/guidance/ta1091"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["tarlatamab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":["dellphi-304","dellphi-305","lurbinectedin-basket-sclc"],"people":[],"bottlenecks":[],"keyPapers":["paper-dellphi-301-nejm-2023"],"journals":[],"dependsOn":[],"notes":["Tarlatamab is a bispecific T-cell engager binding delta-like ligand 3 on small-cell lung cancer and CD3 on T cells. In this phase 2 trial, 220 patients who had had a median of two previous lines received tarlatamab 10 mg or 100 mg intravenously every two weeks. Objective response by blinded independent central review was 40 percent (97.5 percent confidence interval 29 to 52) at 10 mg and 32 percent (21 to 44) at 100 mg; response lasted at least six months in 59 percent (40 of 68) and was ongoing at cutoff in 55 and 57 percent of responders. Median progression-free survival was 4.9 months (95 percent confidence interval 2.9 to 6.7) at 10 mg and 3.9 months at 100 mg. Cytokine release syndrome occurred in 51 percent at 10 mg and 61 percent at 100 mg, with immune effector cell-associated neurotoxicity syndrome in a minority; 3 percent discontinued for a related event (New England Journal of Medicine 2023). The FDA granted accelerated approval on 16 May 2024 and traditional approval on 19 November 2025. NICE TA1091 (20 August 2025) does not recommend tarlatamab in England."],"nct":"NCT05060016","phase":"2","setting":"A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-301).","sponsor":"Amgen","result":"Objective response 40 percent at the 10 mg dose and 32 percent at 100 mg in previously treated small-cell lung cancer; median progression-free survival 4.9 and 3.9 months.","started":"2021-12-01","startedType":"actual","yearReported":2023,"enrolled":222,"enrolledBasis":"registry","outcomes":[],"replication":"DeLLphi-304 confirmed the benefit against chemotherapy in the second line."},{"id":"nct07659795","kind":"trial","name":"A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer","aka":["TARGET-D 203"],"tldr":"A phase 2 trial of VS-7375, Cetuximab, Panitumumab in colorectal cancer, run by Verastem, Inc., now recruiting.","summary":"A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer is a phase 2 interventional study registered as NCT07659795 by Verastem, Inc., with 150 participants planned, started 2026-07-28 and due to reach its primary completion in 2027-06. Interventions recorded: VS-7375, cetuximab, panitumumab, Cetuximab + mFOLFOX6. Conditions listed: Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07659795","url":"https://clinicaltrials.gov/study/NCT07659795"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["vs-7375","cetuximab","panitumumab","folfox"],"companies":["verastem"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07659795","phase":"2","setting":"A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, With and Without an Anti-EGFR Antibody, and With an Anti-EGFR Antibody and Chemotherapy, in Patients With Metastatic KRAS G12D-Mutated Colorectal Adenocarcinoma (TARGET-D 203)","sponsor":"Verastem, Inc.","started":"2026-07-28","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07659782","kind":"trial","name":"A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer","aka":["TARGET-D 202"],"tldr":"A phase 2 trial of VS-7375 in non-small-cell lung cancer and small-cell lung cancer, run by Verastem, Inc., now recruiting.","summary":"A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT07659782 by Verastem, Inc., with 105 participants planned, started 2026-07-22 and due to reach its primary completion in 2027-06. Interventions recorded: VS-7375. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07659782","url":"https://clinicaltrials.gov/study/NCT07659782"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["vs-7375"],"companies":["verastem"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07659782","phase":"2","setting":"A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, in Patients With Previously Treated, Advanced KRAS G12D-Mutated Non-Small Cell Lung Cancer (TARGET-D 202)","sponsor":"Verastem, Inc.","started":"2026-07-22","startedType":"actual","enrolled":105,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07644559","kind":"trial","name":"A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer","aka":["TARGET-D 201"],"tldr":"A phase 2 trial of VS-7375, Cetuximab in pancreatic ductal adenocarcinoma, run by Verastem, Inc., now recruiting.","summary":"A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer is a phase 2 interventional study registered as NCT07644559 by Verastem, Inc., with 180 participants planned, started 2026-06-16 and due to reach its primary completion in 2027-06. Interventions recorded: VS-7375, cetuximab. Conditions listed: Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07644559","url":"https://clinicaltrials.gov/study/NCT07644559"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["vs-7375","cetuximab"],"companies":["verastem"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07644559","phase":"2","setting":"A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and With Cetuximab, in Patients With Metastatic KRAS G12D-Mutated Pancreatic Cancer (TARGET-D 201)","sponsor":"Verastem, Inc.","started":"2026-06-16","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06514794","kind":"trial","name":"A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)","aka":["T-RRex"],"tldr":"A phase 2 trial of WU-CART-007 in acute lymphoblastic leukaemia and non-Hodgkin lymphoma, run by Allotera Therapeutics, now recruiting.","summary":"A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex) is a phase 2 interventional study registered as NCT06514794 by Allotera Therapeutics, with 125 participants planned, started 2025-01-31 and due to reach its primary completion in 2026-12-30. Interventions recorded: WU-CART-007.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06514794","url":"https://clinicaltrials.gov/study/NCT06514794"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["allotera-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06514794","phase":"2","setting":"A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed/Refractory Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-RRex)","sponsor":"Allotera Therapeutics","started":"2025-01-31","startedType":"actual","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06695845","kind":"trial","name":"A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors","aka":["DiscovHER PAN-206"],"tldr":"A phase 2 trial of Zanidatamab in oesophageal cancer and colorectal cancer, run by Jazz Pharmaceuticals, now recruiting.","summary":"A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors is a phase 2 interventional study registered as NCT06695845 by Jazz Pharmaceuticals, with 200 participants planned, started 2025-01-14 and due to reach its primary completion in 2026-12-31. Interventions recorded: Zanidatamab. Conditions listed: Breast Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06695845","url":"https://clinicaltrials.gov/study/NCT06695845"}],"tags":["ctgov-ingest"],"related":[],"cancers":["esophageal","colorectal","endometrial","nsclc","sclc","her2-amplified-colorectal","her2-mutant-nsclc"],"sections":[],"technologies":["bispecific-antibody"],"targets":[],"drugs":["zanidatamab"],"companies":["jazz"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06695845","phase":"2","setting":"A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)","sponsor":"Jazz Pharmaceuticals","started":"2025-01-14","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07005154","kind":"trial","name":"A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer","aka":[],"tldr":"A phase 2 trial of Prednisone, Abiraterone acetate in prostate cancer, run by Astellas Pharma Global Development, Inc., now recruiting.","summary":"A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer is a phase 2 interventional study registered as NCT07005154 by Astellas Pharma Global Development, Inc., with 218 participants planned, started 2025-08-19 and due to reach its primary completion in 2032-05-31. Interventions recorded: ASP5541, Prednisone, Prednisolone, abiraterone acetate, Adrenocorticotropic hormone. Conditions listed: Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07005154","url":"https://clinicaltrials.gov/study/NCT07005154"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["prednisone","abiraterone"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07005154","phase":"2","setting":"A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants With Advanced Prostate Cancer","sponsor":"Astellas Pharma Global Development, Inc.","started":"2025-08-19","startedType":"actual","enrolled":218,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06439771","kind":"trial","name":"A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC","aka":[],"tldr":"A phase 2 trial of YL202 should be intravenously infused in advanced solid tumours, run by MediLink Therapeutics (Suzhou) Co., Ltd., now recruiting.","summary":"A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC is a phase 2 interventional study registered as NCT06439771 by MediLink Therapeutics (Suzhou) Co., Ltd., with 180 participants planned, started 2024-04-23 and due to reach its primary completion in 2026-07-30. Interventions recorded: YL202 should be intravenously infused.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06439771","url":"https://clinicaltrials.gov/study/NCT06439771"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["her2"],"drugs":["yl202"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06439771","phase":"2","setting":"A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With Locally Advanced or Metastatic Breast Cancer With TNBC, HR-Positive, HER2-Zero-expression or HER2-Low-expression","sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","started":"2024-04-23","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06985147","kind":"trial","name":"A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)","aka":[],"tldr":"A phase 2 trial of DISC-3405 in myeloproliferative neoplasms, run by Disc Medicine, Inc, active and no longer recruiting.","summary":"A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV) is a phase 2 interventional study registered as NCT06985147 by Disc Medicine, Inc, with 60 participants enrolled, started 2025-08-12 and due to reach its primary completion in 2027-02. Interventions recorded: DISC-3405.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06985147","url":"https://clinicaltrials.gov/study/NCT06985147"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","polycythaemia-vera"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["disc-medicine"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06985147","phase":"2","setting":"A Phase 2, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DISC-3405 in Participants With Polycythemia Vera (PV)","sponsor":"Disc Medicine, Inc","started":"2025-08-12","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06745323","kind":"trial","name":"A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC","aka":["DeLLphi-309"],"tldr":"A phase 2 trial of Tarlatamab in small-cell lung cancer, run by Amgen, active and no longer recruiting.","summary":"A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC is a phase 2 interventional study registered as NCT06745323 by Amgen, with 252 participants enrolled, started 2025-02-26 and due to reach its primary completion in 2029-05-10. Interventions recorded: Tarlatamab. Conditions listed: Small Cell Lung Cancer (SCLC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06745323","url":"https://clinicaltrials.gov/study/NCT06745323"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["tarlatamab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06745323","phase":"2","setting":"A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With Small Cell Lung Cancer (SCLC) (DeLLphi-309)","sponsor":"Amgen","started":"2025-02-26","startedType":"actual","enrolled":252,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06710288","kind":"trial","name":"A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In P","aka":[],"tldr":"A phase 2 trial of Gemcitabine, Nogapendekin alfa inbakicept in ovarian cancer, run by ImmunityBio, Inc., now recruiting.","summary":"A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer is a phase 2 interventional study registered as NCT06710288 by ImmunityBio, Inc., with 20 participants planned, started 2024-11-06 and due to reach its primary completion in 2027-05. Interventions recorded: Gemcitabine, N-803, M-CENK. Conditions listed: Platinum-resistant Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06710288","url":"https://clinicaltrials.gov/study/NCT06710288"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["cytokine-therapy","cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","nogapendekin-alfa"],"companies":["immunitybio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06710288","phase":"2","setting":"A Phase 2, Open-label, Single-arm Study Of Autologous Memory Cytokine Enriched Natural Killer (M-CENK) Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer","sponsor":"ImmunityBio, Inc.","started":"2024-11-06","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04485949","kind":"trial","name":"A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma","aka":[],"tldr":"A phase 2 trial of Temozolomide in glioma & glioblastoma, run by Imvax, active and no longer recruiting.","summary":"A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma is a phase 2 interventional study registered as NCT04485949 by Imvax, with 99 participants enrolled, started 2023-03-20 and due to reach its primary completion in 2027-01. Interventions recorded: IGV-001 Cell Immunotherapy, Placebo, Standard of Care (SOC): Radiation Therapy and SOC: Temozolomide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04485949","url":"https://clinicaltrials.gov/study/NCT04485949"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04485949","phase":"2","setting":"A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy of IGV-001, an Autologous Cell Immunotherapy With Antisense Oligonucleotide (IMV-001) Targeting IGF-1R, in Newly Diagnosed Patients With Glioblastoma","sponsor":"Imvax","started":"2023-03-20","startedType":"actual","enrolled":99,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06929624","kind":"trial","name":"A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma","aka":[],"tldr":"A phase 3 trial testing SHR-A1912 in diffuse large B-cell lymphoma, now recruiting.","summary":"A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma is a phase 3 interventional study registered as NCT06929624, led by Suzhou Suncadia Biopharmaceuticals, and recruiting on the registry. Official title: A Phase 3, Open-label, Randomised Study of SHR-A1912 Combined With Rituximab + Gemcitabine + Oxaliplatin (R-GEMOX) Versus R-GEMOX in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma. Planned enrolment is 280 participants (estimated). The study started in 2025-04-24 and primary completion is expected in 2027-03. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06929624","url":"https://clinicaltrials.gov/study/NCT06929624"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-a1912"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06929624","phase":"3","setting":"A Phase 3, Open-label, Randomized Study of SHR-A1912 Combined With Rituximab + Gemcitabine + Oxaliplatin (R-GEMOX) Versus R-GEMOX in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma","sponsor":"Suzhou Suncadia Biopharmaceuticals","started":"2025-04-24","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07234162","kind":"trial","name":"A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)","aka":["JACKPOT19"],"tldr":"A phase 3 trial of Golidocitinib run by Dizal Pharmaceuticals, now recruiting.","summary":"A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19) is a phase 3 interventional study registered as NCT07234162 by Dizal Pharmaceuticals, with 218 participants planned, started 2024-05-13. Conditions listed: Peripheral T-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07234162","url":"https://clinicaltrials.gov/study/NCT07234162"}],"tags":["ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["golidocitinib"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07234162","phase":"3","setting":"A Phase 3, Open-Label, Randomized, Multinational Study to Investigate the Anti-tumor Efficacy of Golidocitinib Versus Investigator's Choice in Adult Patients With Relapsed/Refractory Peripheral T-cell Lymphoma","sponsor":"Dizal Pharmaceuticals","started":"2024-05-13","startedType":"actual","enrolled":218,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06007690","kind":"trial","name":"A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma","aka":["CoMpass"],"tldr":"A phase 3 trial of Bel-sar in uveal melanoma, run by Aura Biosciences, active and no longer recruiting.","summary":"A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma is a phase 3 interventional study registered as NCT06007690 by Aura Biosciences, with 108 participants enrolled, started 2023-12-06 and due to reach its primary completion in 2027-11-15. Interventions recorded: Bel-sar, Suprachoroidal Microinjector, Infrared Laser, Sham Infrared Laser and Sham Microinjector.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06007690","url":"https://clinicaltrials.gov/study/NCT06007690"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["uveal-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["aura-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06007690","phase":"3","setting":"A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma","sponsor":"Aura Biosciences","started":"2023-12-06","startedType":"actual","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05243550","kind":"trial","name":"A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer","aka":["ENVISION"],"tldr":"A phase 3 trial of UGN-102 in bladder & urothelial cancer, run by UroGen Pharma Ltd., active and no longer recruiting.","summary":"A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer is a phase 3 interventional study registered as NCT05243550 by UroGen Pharma Ltd., with 240 participants enrolled, started 2022-03-01 and due to reach its primary completion in 2023-04-26. Interventions recorded: UGN-102. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05243550","url":"https://clinicaltrials.gov/study/NCT05243550"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["urogen-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05243550","phase":"3","setting":"A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients With Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence","sponsor":"UroGen Pharma Ltd.","started":"2022-03-01","startedType":"actual","yearReported":2024,"enrolled":240,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete Response Rate (CRR)","primary":true,"unit":"%","arms":[{"name":"UGN-102","n":240,"value":76.7,"note":"95% CI 70.8 to 81.9; Figures from the ClinicalTrials.gov results section (first posted 2024-11-04), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT05243550?tab=results"}]},{"id":"nct06774131","kind":"trial","name":"A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer","aka":[],"tldr":"A phase 3 trial testing UGN-104 in bladder & urothelial cancer, now recruiting.","summary":"A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer is a phase 3 interventional study registered as NCT06774131, led by UroGen Pharma, and recruiting on the registry. Official title: A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-104, a Novel Formulation of UGN-101, for the Treatment of Patients With Low-grade Upper Tract Urothelial Cancer (LG-UTUC). Planned enrolment is 70 participants (estimated). The study started in 2025-08-06 and primary completion is expected in 2027-03. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06774131","url":"https://clinicaltrials.gov/study/NCT06774131"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial"],"sections":[],"technologies":[],"targets":[],"drugs":["ugn-104"],"companies":["urogen-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06774131","phase":"3","setting":"A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-104, a Novel Formulation of UGN-101, for the Treatment of Patients With Low-grade Upper Tract Urothelial Cancer (LG-UTUC)","sponsor":"UroGen Pharma","started":"2025-08-06","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03459534","kind":"trial","name":"A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs","aka":[],"tldr":"A phase 3 trial of Radotinib HCl in chronic myeloid leukaemia, run by Il-Yang Pharm. Co., Ltd., now recruiting.","summary":"A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs is a phase 3 interventional study registered as NCT03459534 by Il-Yang Pharm. Co., Ltd., with 173 participants planned, started 2018-06-25 and due to reach its primary completion in 2027-06-30. Interventions recorded: Radotinib HCl.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03459534","url":"https://clinicaltrials.gov/study/NCT03459534"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cml","cml-chronic-phase"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["imatinib","radotinib"],"companies":["il-yang-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03459534","phase":"3","setting":"A Phase 3 Multinational, Multi-center, Single-arm, Open-label Study for the Efficacy and Safety of Radotinib in Ph+ Chronic Phase Chronic Myeloid Leukemia Patients With Failure or Intolerance to Previous TKIs Therapy Including Imatinib","sponsor":"Il-Yang Pharm. Co., Ltd.","started":"2018-06-25","startedType":"actual","enrolled":173,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01394679","kind":"trial","name":"A Phase 3 Study of 99mTC-EC-DG SPECT/CT Versus PET/CT in Lung Cancer","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Cell>Point LLC, not yet recruiting.","summary":"A Phase 3 Study of 99mTC-EC-DG SPECT/CT Versus PET/CT in Lung Cancer is a phase 3, interventional study registered as NCT01394679 by Cell>Point LLC, with a registry enrolment figure of 154 participants, started 2025-05-01 and due to reach its primary completion in 2025-12. Interventions recorded: (99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose); 18 F FDG followed by PET/CT imaging. Conditions listed: Lung Cancer. Primary outcome: Efficacy:Comparison of 99mTc-EcC-DG SPECT/CT images to 18F-FDG PET/CT images of primary lung cancer lesion and metastatic lesions. Lung eligibility wording from the registry: \"The patient has had a non incisional biopsy demonstrating definitive evidence for lung cancer OR have clinical evidence and CT scan results consistent with a diagnosis of lung cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01394679","url":"https://clinicaltrials.gov/study/NCT01394679"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01394679","phase":"3","setting":"A Multicenter Phase 3 Study Comparing the Diagnostic Accuracy of 99mTc EC DG SPECT/CT Versus 18F FDG PET/CT for Diagnosing and Staging Patients Who Have Clinical and Radiological (CT) Evidence Consistent With a Diagnosis of Lung Cancer","sponsor":"Cell>Point LLC","started":"2025-05-01","startedType":"estimated","enrolled":154,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06601335","kind":"trial","name":"A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)","aka":[],"tldr":"A phase 3 trial testing AK117 in head and neck squamous cell carcinoma, now recruiting.","summary":"A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) is a phase 3 interventional study registered as NCT06601335, led by Akeso, and recruiting on the registry. Official title: A Randomised, Controlled, Multicenter Phase 3 Study of AK112 in Combination With AK117 Versus Pembrolizumab as First Line Treatment for a Programmed Cell Death-ligand 1 (PD-L1) Positive Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC). Planned enrolment is 510 participants (estimated). The study started in 2024-10-30 and primary completion is expected in 2027-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06601335","url":"https://clinicaltrials.gov/study/NCT06601335"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["ak117"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06601335","phase":"3","setting":"A Randomized, Controlled, Multicenter Phase 3 Study of AK112 in Combination With AK117 Versus Pembrolizumab as First Line Treatment for a Programmed Cell Death-ligand 1 (PD-L1) Positive Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)","sponsor":"Akeso","started":"2024-10-30","startedType":"actual","enrolled":510,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07024173","kind":"trial","name":"A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial testing HRS-8080 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer is a phase 3 interventional study registered as NCT07024173, led by Shandong Suncadia Medicine, and recruiting on the registry. Official title: A Multicenter, Open-label, Randomised Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy. Planned enrolment is 240 participants (estimated). The study started in 2025-07-23 and primary completion is expected in 2026-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07024173","url":"https://clinicaltrials.gov/study/NCT07024173"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["hrs-8080"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07024173","phase":"3","setting":"A Multicenter, Open-label, Randomized Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy","sponsor":"Shandong Suncadia Medicine","started":"2025-07-23","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07174908","kind":"trial","name":"A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation","aka":[],"tldr":"A phase 3 trial testing IN10018 in non-small-cell lung cancer, now recruiting.","summary":"A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation is a phase 3 interventional study registered as NCT07174908, led by InxMed (Shanghai), and recruiting on the registry. Official title: A Phase 3 Multicenter, Randomised, Controlled, and Open-Label Study of IN10018 in Combination With D-1553 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation. Planned enrolment is 400 participants (estimated). The study started in 2025-09-10 and primary completion is expected in 2028-09. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07174908","url":"https://clinicaltrials.gov/study/NCT07174908"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["in10018"],"companies":["inxmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07174908","phase":"3","setting":"A Phase 3 Multicenter, Randomized, Controlled, and Open-Label Study of IN10018 in Combination With D-1553 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation","sponsor":"InxMed (Shanghai)","started":"2025-09-10","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07833202","kind":"trial","name":"A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutatio","aka":[],"tldr":"A phase 3 trial of IN10018, tislelizumab, carboplatin and pemetrexed in lung cancer, run by Shanghai Jeyou Pharmaceutical Co., Ltd., not yet recruiting.","summary":"A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation is a phase 3, randomised interventional study registered as NCT07833202 by Shanghai Jeyou Pharmaceutical Co., Ltd., with a registry enrolment figure of 416 participants, started 2026-10 and due to reach its primary completion in 2029-04. Interventions recorded: Sosimerasib in combination with IN10018; Tislelizumab + Carboplatin + Pemetrexed. Conditions listed: NSCLC. Primary outcome: Progression-Free Survival (PFS). Lung eligibility wording from the registry: \"Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV Non-squamous NSCLC disease\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07833202","url":"https://clinicaltrials.gov/study/NCT07833202"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["kras-g12c-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["in10018","tislelizumab","carboplatin","pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07833202","phase":"3","setting":"A Phase 3, Randomized, Positive Controlled, Open-Label and Multicenter Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation","sponsor":"Shanghai Jeyou Pharmaceutical Co., Ltd.","started":"2026-10","startedType":"estimated","enrolled":416,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07182682","kind":"trial","name":"A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Ins","aka":["WU-KONG16"],"tldr":"A phase 3 trial of Sunvozertinib in non-small-cell lung cancer and small-cell lung cancer, run by Dizal (Jiangsu) Pharmaceutical Co., Ltd., now recruiting.","summary":"A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery is a phase 3 interventional study registered as NCT07182682 by Dizal (Jiangsu) Pharmaceutical Co., Ltd., with 360 participants planned, started 2025-12-01 and due to reach its primary completion in 2029-09. Interventions recorded: sunvozertinib, Matching Placebo. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07182682","url":"https://clinicaltrials.gov/study/NCT07182682"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["sunvozertinib"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07182682","phase":"3","setting":"A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Anti-Tumor Efficacy and Safety of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Stage IB-IIIA Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery (WU-KONG16)","sponsor":"Dizal (Jiangsu) Pharmaceutical Co., Ltd.","started":"2025-12-01","startedType":"actual","enrolled":360,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03394365","kind":"trial","name":"A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failu","aka":["ALLELE"],"tldr":"A phase 3 trial of Tabelecleucel run by Pierre Fabre Medicament, now recruiting.","summary":"A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy is a phase 3 interventional study registered as NCT03394365 by Pierre Fabre Medicament, with 115 participants planned, started 2017-12-29. Conditions listed: Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders, Allogeneic Hematopoietic Cell Transplant. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03394365","url":"https://clinicaltrials.gov/study/NCT03394365"}],"tags":["ctgov-ingest"],"related":[],"cancers":["post-transplant-lymphoproliferative-disorder"],"sections":[],"technologies":["virus-specific-t-cells"],"targets":[],"drugs":["tabelecleucel"],"companies":["pierre-fabre"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03394365","phase":"3","setting":"Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy","sponsor":"Pierre Fabre Medicament","started":"2017-12-29","startedType":"actual","enrolled":115,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06331299","kind":"trial","name":"A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer","aka":["UTOPIA"],"tldr":"A phase 3 trial testing UGN-103 in bladder & urothelial cancer, active and no longer recruiting.","summary":"A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer is a phase 3 interventional study registered as NCT06331299, led by UroGen Pharma, and active but no longer recruiting on the registry. Official title: A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel Formulation of UGN-102, for the Treatment of Patients With Low-grade (LG) Non-muscle Invasive Bladder Cancer (NMIBC) at Intermediate-risk (IR) of Recurrence. Planned enrolment is 99 participants (actual). The study started in 2024-08-29 and primary completion is expected in 2025-09-11. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06331299","url":"https://clinicaltrials.gov/study/NCT06331299"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ugn-103"],"companies":["urogen-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06331299","phase":"3","setting":"A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel Formulation of UGN-102, for the Treatment of Patients With Low-grade (LG) Non-muscle Invasive Bladder Cancer (NMIBC) at Intermediate-risk (IR) of Recurrence","sponsor":"UroGen Pharma","started":"2024-08-29","startedType":"actual","enrolled":99,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04680052","kind":"trial","name":"A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Pa","aka":["InMIND","inMIND","Tafasitamab with lenalidomide and rituximab in relapsed or refractory follicular lymphoma"],"tldr":"A phase 3 trial of Tafasitamab, Rituximab, Lenalidomide in follicular lymphoma, run by Incyte Corporation, active and no longer recruiting.","summary":"A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. is a phase 3 interventional study registered as NCT04680052 by Incyte Corporation, with 654 participants enrolled, started 2021-04-15 and due to reach its primary completion in 2024-02-23. Interventions recorded: tafasitamab, rituximab, lenalidomide, placebo. Conditions listed: Follicular Lymphoma, Marginal Zone Lymphoma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04680052","url":"https://clinicaltrials.gov/study/NCT04680052"}],"tags":["ctgov-ingest"],"related":["lymphoma-roadmap","paper-inmind-tafasitamab-lenalidomide-rituximab-follicular-lancet-2026","rosewood"],"cancers":["follicular-lymphoma","marginal-zone-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["monoclonal-antibody","protac-degrader"],"targets":["cd19","cd20"],"drugs":["tafasitamab","rituximab","lenalidomide"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-inmind-tafasitamab-lenalidomide-rituximab-follicular-lancet-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04680052","phase":"3","setting":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma","sponsor":"Incyte Corporation","result":"Median investigator-assessed progression-free survival 22.4 against 13.9 months (hazard ratio 0.43, 95 per cent confidence interval 0.32 to 0.58).","started":"2021-04-15","startedType":"actual","yearReported":2025,"enrolled":654,"enrolledBasis":"registry","outcomes":[{"endpoint":"FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First","primary":true,"unit":"months","arms":[{"name":"FL: Tafasitamab + Rituximab + Lenalidomide","n":273,"value":22.37,"note":"95% CI 19.22 to NA; Figures from the ClinicalTrials.gov results section (first posted 2025-04-04), not from a publication"},{"name":"FL: Placebo + Rituximab + Lenalidomide","n":275,"value":13.93,"note":"95% CI 11.53 to 16.39"}],"source":"https://clinicaltrials.gov/study/NCT04680052?tab=results"}]},{"id":"nct06496178","kind":"trial","name":"A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma P","aka":[],"tldr":"A phase 3 trial of Petosemtamab in head and neck squamous cell carcinoma, run by Merus B.V., active and no longer recruiting.","summary":"A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2) is a phase 3 interventional study registered as NCT06496178 by Merus B.V., with 621 participants enrolled, started 2024-06-25 and due to reach its primary completion in 2028-02. Interventions recorded: Petosemtamab, Investigator's Choice, Investigator's Choice, Investigator's Choice. Conditions listed: Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06496178","url":"https://clinicaltrials.gov/study/NCT06496178"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["bispecific-antibody"],"targets":[],"drugs":["petosemtamab"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06496178","phase":"3","setting":"A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared With Investigator's Choice Monotherapy Treatment in Previously Treated Patients With Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma","sponsor":"Merus B.V.","started":"2024-06-25","startedType":"actual","enrolled":621,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05566041","kind":"trial","name":"A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 With a Platinum Doublet or a Platinum Doublet in Small Cell Lung Cancer","aka":["REPLATINUM"],"tldr":"A phase 3 trial of Etoposide, Carboplatin and Cisplatin in small-cell lung cancer, run by EpicentRx, Inc., active and no longer recruiting.","summary":"A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 With a Platinum Doublet or a Platinum Doublet in Small Cell Lung Cancer is a phase 3 interventional study registered as NCT05566041 by EpicentRx, Inc., with 292 participants enrolled, started 2022-08-01 and due to reach its primary completion in 2025-12-31. Interventions recorded: RRx-001 + eLOOP Device and Cisplatin/carboplatin plus etoposide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05566041","url":"https://clinicaltrials.gov/study/NCT05566041"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["etoposide","carboplatin","cisplatin"],"companies":["epicentrx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05566041","phase":"3","setting":"REPLATINUM: A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 Administered Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond Small Cell Lung Cancer","sponsor":"EpicentRx, Inc.","started":"2022-08-01","startedType":"actual","enrolled":292,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00938652","kind":"trial","name":"A Phase 3, Multi-Center Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial of Gemcitabine, Carboplatin and Iniparib in Breast cancer, run by Sanofi, completed.","summary":"A Phase 3, Multi-Center Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer is a phase 3 interventional study registered as NCT00938652 by Sanofi, with 519 participants recorded, started 2009-07 and reaching its primary completion in 2011-01. Interventions recorded: gemcitabine/carboplatin, Iniparib. Conditions recorded: Breast Cancer.\n\nLinked to the drug Iniparib because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00938652","url":"https://clinicaltrials.gov/study/NCT00938652"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["gemcitabine","carboplatin","iniparib"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00938652","phase":"3","setting":"A Phase 3, Multi-Center, Open-Label, Randomized Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer","sponsor":"Sanofi","started":"2009-07","enrolled":519,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05862272","kind":"trial","name":"A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis","aka":[],"tldr":"A phase 3 trial of Relugolix in endometrial cancer, run by Sumitomo Pharma Switzerland GmbH, now recruiting.","summary":"A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis is a phase 3 interventional study registered as NCT05862272 by Sumitomo Pharma Switzerland GmbH, with 1000 participants planned, started 2023-08-14 and due to reach its primary completion in 2029-07. Interventions recorded: Relugolix Combination Tablet.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05862272","url":"https://clinicaltrials.gov/study/NCT05862272"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["relugolix"],"companies":["sumitomo-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05862272","phase":"3","setting":"A Phase 3B, Single-Arm, Open-Label Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids or Moderate to Severe Pain Associated With Endometriosis","sponsor":"Sumitomo Pharma Switzerland GmbH","started":"2023-08-14","startedType":"actual","enrolled":1000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05024097","kind":"trial","name":"A Phase I-II Study to Test the Safety and Efficacy of PD1 (AB122) and Adenosine Receptor (AB928) Antagonists With Chemotherapy After Short-Course Radiation for","aka":["PANTHER"],"tldr":"A phase 2 trial of zimberelimab in colorectal cancer, run by Weill Medical College of Cornell University, now recruiting.","summary":"A Phase I-II Study to Test the Safety and Efficacy of PD1 (AB122) and Adenosine Receptor (AB928) Antagonists With Chemotherapy After Short-Course Radiation for Rectal Cancer. is a phase 2, interventional study registered as NCT05024097 by Weill Medical College of Cornell University, with a registry enrolment figure of 43 participants, started 2022-03-31 and due to reach its primary completion in 2026-12. Interventions recorded: Etrumadenant (AB928); Radiation therapy; FOLFOX regimen; Zimberelimab (AB122). Conditions listed: Rectal Cancer. Primary outcome: Number of treated patients who achieve complete pathologic response. Colorectal eligibility wording from the registry: \"* Histologically confirmed diagnosis of adenocarcinoma of the rectum\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05024097","url":"https://clinicaltrials.gov/study/NCT05024097"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["zimberelimab"],"companies":["arcus-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05024097","phase":"2","setting":"A Phase I-II Study to Test the Safety and Efficacy of PD1 (AB122) and Adenosine Receptor (AB928) Antagonists With Chemotherapy After Short-Course Radiation for Rectal Cancer.","sponsor":"Weill Medical College of Cornell University","started":"2022-03-31","startedType":"actual","enrolled":43,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05970016","kind":"trial","name":"A Phase I/II Clinical Study in Patients with Advanced Solid Tumor.","aka":[],"tldr":"A phase 1/2 trial of TCC1727 tablet（1） in advanced solid tumours, run by Beijing Tide Pharmaceutical Co., Ltd, now recruiting.","summary":"A Phase I/II Clinical Study in Patients with Advanced Solid Tumor. is a phase 1/2 interventional study registered as NCT05970016 by Beijing Tide Pharmaceutical Co., Ltd, with 56 participants planned, started 2023-08-07 and due to reach its primary completion in 2025-07-30. Interventions recorded: TCC1727 tablet（1） and TCC1727 tablet（2）.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05970016","url":"https://clinicaltrials.gov/study/NCT05970016"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["beijing-tide-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05970016","phase":"1/2","setting":"A Phase I/II Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TCC1727 Tablets in Patients with Advanced Solid Tumor.","sponsor":"Beijing Tide Pharmaceutical Co., Ltd","started":"2023-08-07","startedType":"actual","enrolled":56,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06971523","kind":"trial","name":"A Phase I/II Clinical Study of CTS3497 in Patients With MTAP Deficient Malignacies","aka":[],"tldr":"A phase 1/2 trial of CTS3497 in non-Hodgkin lymphoma, run by CytosinLab Therapeutics Co., Ltd., now recruiting.","summary":"A Phase I/II Clinical Study of CTS3497 in Patients With MTAP Deficient Malignacies is a phase 1/2 interventional study registered as NCT06971523 by CytosinLab Therapeutics Co., Ltd., with 224 participants planned, started 2024-12-25 and due to reach its primary completion in 2028-12-31. Interventions recorded: CTS3497.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06971523","url":"https://clinicaltrials.gov/study/NCT06971523"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06971523","phase":"1/2","setting":"A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of CTS3497 in Patients With MTAP Deficient Advanced Solid Tumors and Lymphomas","sponsor":"CytosinLab Therapeutics Co., Ltd.","started":"2024-12-25","startedType":"actual","enrolled":224,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07136142","kind":"trial","name":"A Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of FH-006 for Injection in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors is a phase 1/2 interventional study registered as NCT07136142 by Jiangsu HengRui Medicine Co., Ltd., with 150 participants planned, started 2025-09-23 and due to reach its primary completion in 2027-02. Interventions recorded: FH-006 for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07136142","url":"https://clinicaltrials.gov/study/NCT07136142"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07136142","phase":"1/2","setting":"A Multicenter, Open Label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of FH-006 for Injection in Patients With Malignant Solid Tumors","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-09-23","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05170958","kind":"trial","name":"A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors","aka":[],"tldr":"A phase 1/2 trial of LBL-024 for Injection in advanced solid tumours, run by Nanjing Leads Biolabs Co.,Ltd, now recruiting.","summary":"A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors is a phase 1/2 interventional study registered as NCT05170958 by Nanjing Leads Biolabs Co.,Ltd, with 396 participants planned, started 2022-01-06 and due to reach its primary completion in 2026-12. Interventions recorded: LBL-024 for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05170958","url":"https://clinicaltrials.gov/study/NCT05170958"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["nanjing-leads-biolabs"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05170958","phase":"1/2","setting":"A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors","sponsor":"Nanjing Leads Biolabs Co.,Ltd","started":"2022-01-06","startedType":"actual","enrolled":396,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06737731","kind":"trial","name":"A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SHR-1681 in advanced solid tumours, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06737731 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 300 participants planned, started 2025-01-21 and due to reach its primary completion in 2026-11. Interventions recorded: SHR-1681.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06737731","url":"https://clinicaltrials.gov/study/NCT06737731"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06737731","phase":"1/2","setting":"A Phase I/II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1681 for Injection in Patients With Malignant Solid Tumors","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-01-21","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07229612","kind":"trial","name":"A Phase I/II Clinical Study of SHR-4298 Injection in Patients With Malignant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SHR-4298 Injection in advanced solid tumours, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Phase I/II Clinical Study of SHR-4298 Injection in Patients With Malignant Solid Tumors is a phase 1/2 interventional study registered as NCT07229612 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 200 participants planned, started 2025-12-03 and due to reach its primary completion in 2028-11. Interventions recorded: SHR-4298 Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07229612","url":"https://clinicaltrials.gov/study/NCT07229612"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07229612","phase":"1/2","setting":"A Multicenter, Open-label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4298 Injection in Patients With Malignant Solid Tumors","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-12-03","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07253116","kind":"trial","name":"A Phase I/II Clinical Study of WJ22096 Tablets in Patients With Advanced Tumors","aka":[],"tldr":"A phase 1/2 trial of WJ22096 in advanced solid tumours, run by Nanjing Jingao biomidical technology Co. Ltd., now recruiting.","summary":"A Phase I/II Clinical Study of WJ22096 Tablets in Patients With Advanced Tumors is a phase 1/2 interventional study registered as NCT07253116 by Nanjing Jingao biomidical technology Co. Ltd., with 20 participants planned, started 2025-11-20 and due to reach its primary completion in 2028-11-30. Interventions recorded: WJ22096.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07253116","url":"https://clinicaltrials.gov/study/NCT07253116"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07253116","phase":"1/2","setting":"A Phase I/II, Dose-Escalation, Dose-Expansion, and Efficacy-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WJ22096 Tablets Administered Orally in Patients With Advanced Solid Tumors","sponsor":"Nanjing Jingao biomidical technology Co. Ltd.","started":"2025-11-20","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04685226","kind":"trial","name":"A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ICP-723 in advanced solid tumours, run by Beijing InnoCare Pharma Tech Co., Ltd., now recruiting.","summary":"A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT04685226 by Beijing InnoCare Pharma Tech Co., Ltd., with 310 participants planned, started 2020-09-27 and due to reach its primary completion in 2028-01-25. Interventions recorded: ICP-723.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04685226","url":"https://clinicaltrials.gov/study/NCT04685226"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["innocare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04685226","phase":"1/2","setting":"A Multicenter, Nonrandomized, Open-Label Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Solid Tumors","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","started":"2020-09-27","startedType":"actual","enrolled":310,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07069062","kind":"trial","name":"A Phase I/Ⅱ Human Study of HY0001a for Injection in Adult Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Test product HY0001a for injection in advanced solid tumours, run by Sichuan Huiyu Pharmaceutical Co., Ltd, now recruiting.","summary":"A Phase I/Ⅱ Human Study of HY0001a for Injection in Adult Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07069062 by Sichuan Huiyu Pharmaceutical Co., Ltd, with 261 participants planned, started 2025-07-21 and due to reach its primary completion in 2027-06. Interventions recorded: Test product HY0001a for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07069062","url":"https://clinicaltrials.gov/study/NCT07069062"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sichuan-huiyu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07069062","phase":"1/2","setting":"A Multicenter, Open-label Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Clinical Efficacy of HY0001a for Injection in Patients With Advanced Malignant Solid Tumors","sponsor":"Sichuan Huiyu Pharmaceutical Co., Ltd","started":"2025-07-21","startedType":"actual","enrolled":261,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06922357","kind":"trial","name":"A Phase I/II of HRS-6719 in Patients With Advanced/Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of HRS-6719 in advanced solid tumours, run by Shandong Suncadia Medicine Co., Ltd., now recruiting.","summary":"A Phase I/II of HRS-6719 in Patients With Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06922357 by Shandong Suncadia Medicine Co., Ltd., with 120 participants planned, started 2025-04-24 and due to reach its primary completion in 2027-12. Interventions recorded: HRS-6719.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06922357","url":"https://clinicaltrials.gov/study/NCT06922357"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06922357","phase":"1/2","setting":"A Phase I/II, Open-label, Multi-centre Study Evaluating the Safety,Tolerability,Pharmacokinetic (PK), Pharmacodynamics, and Preliminary Efficacy of HRS-6719 in Patients With Advanced/Metastatic Solid Tumors With MTAP Deficiency","sponsor":"Shandong Suncadia Medicine Co., Ltd.","started":"2025-04-24","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07417189","kind":"trial","name":"A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 )","aka":[],"tldr":"A phase 1/2 trial of ABSK141-400mg in advanced solid tumours, run by Abbisko Therapeutics Co, Ltd, now recruiting.","summary":"A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 ) is a phase 1/2 interventional study registered as NCT07417189 by Abbisko Therapeutics Co, Ltd, with 401 participants planned, started 2026-03-02 and due to reach its primary completion in 2028-12-30. Interventions recorded: ABSK141-400mg, ABSK141-Recommended Dose for Expansion (RDE), ABSK141-800mg, ABSK141-1200mg and ABSK141-Recommended Phase 2 dose (RP2D).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07417189","url":"https://clinicaltrials.gov/study/NCT07417189"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["abbisko"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07417189","phase":"1/2","setting":"A Phase I/II, Open-Label Study of ABSK141 to Assess Safety, Tolerability, Efficacy and Pharmacokinetics in Patients With KRAS G12D Mutant Advanced Solid Tumors","sponsor":"Abbisko Therapeutics Co, Ltd","started":"2026-03-02","startedType":"actual","enrolled":401,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06245330","kind":"trial","name":"A Phase I/II Study of AST-001 in Subjects With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of AST-001 in pancreatic ductal adenocarcinoma, run by Ascentawits Pharmaceuticals, Ltd, now recruiting.","summary":"A Phase I/II Study of AST-001 in Subjects With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06245330 by Ascentawits Pharmaceuticals, Ltd, with 180 participants planned, started 2022-07-07 and due to reach its primary completion in 2027-08-31. Interventions recorded: AST-001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06245330","url":"https://clinicaltrials.gov/study/NCT06245330"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ascentawits-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06245330","phase":"1/2","setting":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Correlation With AKR1C3 Enzyme Expression of AST-001 in Subjects With Advanced Solid Tumors","sponsor":"Ascentawits Pharmaceuticals, Ltd","started":"2022-07-07","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06239155","kind":"trial","name":"A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of AST-3424 in hepatocellular carcinoma, run by Ascentawits Pharmaceuticals, Ltd, active and no longer recruiting.","summary":"A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06239155 by Ascentawits Pharmaceuticals, Ltd, with 51 participants enrolled, started 2019-09-03 and due to reach its primary completion in 2025-11-30. Interventions recorded: AST-3424.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06239155","url":"https://clinicaltrials.gov/study/NCT06239155"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ascentawits-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06239155","phase":"1/2","setting":"Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of AST-3424 in Treatment of Patients With Advanced Solid Tumors and Its Correlation With AKR1C3 Enzyme Expression","sponsor":"Ascentawits Pharmaceuticals, Ltd","started":"2019-09-03","startedType":"actual","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07123454","kind":"trial","name":"A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphom","aka":[],"tldr":"A phase 1/2 trial of AZD4512 in hodgkin lymphoma and non-hodgkin lymphoma, run by AstraZeneca, now recruiting.","summary":"A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma is a phase 1/2 interventional study registered as NCT07123454 by AstraZeneca, with 91 participants planned, started 2025-09-24 and due to reach its primary completion in 2028-03-01. Interventions recorded: AZD4512. Conditions listed: B-cell Non-Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07123454","url":"https://clinicaltrials.gov/study/NCT07123454"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["azd4512"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07123454","phase":"1/2","setting":"A Modular Phase I/II Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of AZD4512 Monotherapy or in Combination With Other Anticancer Agent(s), in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL) (Lumi-NHL)","sponsor":"AstraZeneca","started":"2025-09-24","startedType":"actual","enrolled":91,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06741644","kind":"trial","name":"A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pemetrexed, Carboplatin, Etoposide, Oxaliplatin, Capecitabine and Docetaxel in advanced solid tumours, run by CStone Pharmaceuticals, now recruiting.","summary":"A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06741644 by CStone Pharmaceuticals, with 800 participants planned, started 2025-02-24 and due to reach its primary completion in 2027-01. Interventions recorded: CS2009, Pemetrexed, Carboplatin, Paclitaxel, Etoposide and Nab-paclitaxel.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06741644","url":"https://clinicaltrials.gov/study/NCT06741644"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pemetrexed","carboplatin","etoposide","oxaliplatin","capecitabine","docetaxel"],"companies":["cstone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06741644","phase":"1/2","setting":"A Phase I/II, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS2009, a Tri-specific Antibody Targeting PD-1/VEGFA/CTLA-4, as Monotherapy and Combination Therapy in Participants With Advanced Solid Tumors","sponsor":"CStone Pharmaceuticals","started":"2025-02-24","startedType":"actual","enrolled":800,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05415072","kind":"trial","name":"A Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas","aka":[],"tldr":"A phase 1/2 trial of DYP688 in uveal melanoma, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"A Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas is a phase 1/2 interventional study registered as NCT05415072 by Novartis Pharmaceuticals, with 66 participants enrolled, started 2022-07-04 and due to reach its primary completion in 2027-10-01. Interventions recorded: DYP688.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05415072","url":"https://clinicaltrials.gov/study/NCT05415072"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["uveal-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05415072-nat-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05415072","phase":"1/2","setting":"A Phase I/II, Multi-center, Open Label Study of DYP688 in Patients With Metastatic Uveal Melanoma (MUM) and Other GNAQ/11 Mutant Melanomas","sponsor":"Novartis Pharmaceuticals","started":"2022-07-04","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06064812","kind":"trial","name":"A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.","aka":[],"tldr":"A phase 1/2 trial of FWD1802 in advanced solid tumours, run by Forward Pharmaceuticals Co., Ltd., now recruiting.","summary":"A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC. is a phase 1/2 interventional study registered as NCT06064812 by Forward Pharmaceuticals Co., Ltd., with 99 participants planned, started 2023-09-12 and due to reach its primary completion in 2026-03. Interventions recorded: FWD1802.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06064812","url":"https://clinicaltrials.gov/study/NCT06064812"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["forward-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06064812","phase":"1/2","setting":"A Phase I/II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of FWD1802in Patients With ER+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer","sponsor":"Forward Pharmaceuticals Co., Ltd.","started":"2023-09-12","startedType":"actual","enrolled":99,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07083323","kind":"trial","name":"A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of HY05350 for injection in advanced solid tumours, run by Sichuan Huiyu Pharmaceutical Co., Ltd, now recruiting.","summary":"A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07083323 by Sichuan Huiyu Pharmaceutical Co., Ltd, with 262 participants planned, started 2025-07-22 and due to reach its primary completion in 2028-03-31. Interventions recorded: HY05350 for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07083323","url":"https://clinicaltrials.gov/study/NCT07083323"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["mesothelin"],"drugs":[],"companies":["sichuan-huiyu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07083323","phase":"1/2","setting":"A Multicenter, Open-label Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Clinical Efficacy of HY05350 for Injection in Patients With MSLN-positive Advanced Solid Tumors","sponsor":"Sichuan Huiyu Pharmaceutical Co., Ltd","started":"2025-07-22","startedType":"actual","enrolled":262,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06712680","kind":"trial","name":"A Phase I/II Study of HYP-6589 Monotherapy in Treating Advanced Solid Tumors and in Combination With Tyrosine Kinase Inhibitors in Treating Patients With Advanced NSCLC Positive for Driver Genes","aka":[],"tldr":"A phase 1/2 trial of Test Product HYP-6589 in advanced solid tumours, run by Sichuan Huiyu Pharmaceutical Co., Ltd, now recruiting.","summary":"A Phase I/II Study of HYP-6589 Monotherapy in Treating Advanced Solid Tumors and in Combination With Tyrosine Kinase Inhibitors in Treating Patients With Advanced NSCLC Positive for Driver Genes is a phase 1/2 interventional study registered as NCT06712680 by Sichuan Huiyu Pharmaceutical Co., Ltd, with 115 participants planned, started 2024-11-27 and due to reach its primary completion in 2028-04-10. Interventions recorded: Test Product HYP-6589.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06712680","url":"https://clinicaltrials.gov/study/NCT06712680"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sichuan-huiyu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06712680","phase":"1/2","setting":"A Phase I/II , Open-label, Multi-center, Multi-cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HYP-6589 Monotherapy in Advanced Solid Tumors and Combination With Tyrosine Kinase Inhibitors in Patients With Advanced NSCLC With Target-driven Gene Positivity","sponsor":"Sichuan Huiyu Pharmaceutical Co., Ltd","started":"2024-11-27","startedType":"actual","enrolled":115,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05615974","kind":"trial","name":"A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors","aka":[],"tldr":"A phase 1/2 trial of Toripalimab and Rituximab in advanced solid tumours, run by LaNova Medicines Limited, now recruiting.","summary":"A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors is a phase 1/2 interventional study registered as NCT05615974 by LaNova Medicines Limited, with 139 participants planned, started 2023-01-11 and due to reach its primary completion in 2027-01-11. Interventions recorded: LM101, Toripalimab and Rituximab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05615974","url":"https://clinicaltrials.gov/study/NCT05615974"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["toripalimab","rituximab"],"companies":["lanova-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05615974","phase":"1/2","setting":"A Phase I/II, Open-label, Dose Escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of LM-101 Injection as a Single Agent or Combination Therapy in Patients With Advanced Malignant Tumors","sponsor":"LaNova Medicines Limited","started":"2023-01-11","startedType":"actual","enrolled":139,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06682780","kind":"trial","name":"A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours","aka":[],"tldr":"A phase 1/2 trial of Docetaxel, Toripalimab, Carboplatin, Niraparib and Lenvatinib in advanced solid tumours, run by LaNova Medicines Limited, now recruiting.","summary":"A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours is a phase 1/2 interventional study registered as NCT06682780 by LaNova Medicines Limited, with 320 participants planned, started 2025-09-17 and due to reach its primary completion in 2028-12-25. Interventions recorded: LM-2417, Docetaxel, Toripalimab/Tirelizumab, Carboplatin, Niraparib and Lenvatinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06682780","url":"https://clinicaltrials.gov/study/NCT06682780"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["docetaxel","toripalimab","carboplatin","niraparib","lenvatinib"],"companies":["lanova-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06682780","phase":"1/2","setting":"An Open-label, Dose-escalation, and Dose-expansion Phase I/II Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Efficacy of LM-2417 for Injection Alone or in Combination With Other Antitumor Agents in Patients With Advanced Solid Tumors","sponsor":"LaNova Medicines Limited","started":"2025-09-17","startedType":"actual","enrolled":320,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02734004","kind":"trial","name":"A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.","aka":["MEDIOLA"],"tldr":"A phase 1/2 trial of Olaparib and Bevacizumab in ovarian cancer, small-cell lung cancer and gastric & gastro-oesophageal junction cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors. is a phase 1/2 interventional study registered as NCT02734004 by AstraZeneca, with 264 participants enrolled, started 2016-03-17 and due to reach its primary completion in 2021-09-17. Interventions recorded: Olaparib, MEDI4736 and Bevacizumab. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02734004","url":"https://clinicaltrials.gov/study/NCT02734004"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","sclc","gastric"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["olaparib","bevacizumab"],"companies":["astrazeneca","iqvia"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02734004-lancet-oncol-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02734004","phase":"1/2","setting":"A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors","sponsor":"AstraZeneca","started":"2016-03-17","startedType":"actual","yearReported":2023,"enrolled":264,"enrolledBasis":"registry","outcomes":[{"endpoint":"Initial Stage Cohorts: Disease Control Rate (DCR) at Week 12","primary":true,"unit":"%","arms":[{"name":"Initial Stage: Small Cell Lung Cancer","n":38,"value":28.9,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-10-13), not from a publication"},{"name":"Initial Stage: Breast Cancer","n":30,"value":80},{"name":"Initial Stage: Ovarian Cancer","n":32,"value":81.3},{"name":"Initial Stage: Gastric Cancer","n":39,"value":25.6}],"source":"https://clinicaltrials.gov/study/NCT02734004?tab=results"},{"endpoint":"Second Stage Cohort: Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Second Stage: Ovarian Cancer Expansion","n":51,"value":92.2,"note":"95% CI 81.12 to 97.82; Figures from the ClinicalTrials.gov results section (first posted 2023-10-13), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT02734004?tab=results"},{"endpoint":"Second Stage Cohorts: DCR at Week 24","primary":true,"unit":"%","arms":[{"name":"Second Stage: Ovarian Cancer Triplet","n":31,"value":74.2,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-10-13), not from a publication"},{"name":"Second Stage: Ovarian Cancer Doublet","n":32,"value":28.1}],"source":"https://clinicaltrials.gov/study/NCT02734004?tab=results"}]},{"id":"nct07075328","kind":"trial","name":"A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma","aka":[],"tldr":"A phase 1/2 trial of an investigational treatment in non-Hodgkin lymphoma, run by Otsuka Medical Devices Co., Ltd. Japan, now recruiting.","summary":"A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma is a phase 1/2 interventional study registered as NCT07075328 by Otsuka Medical Devices Co., Ltd. Japan, with 49 participants planned, started 2024-04-01 and due to reach its primary completion in 2028-02-28.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07075328","url":"https://clinicaltrials.gov/study/NCT07075328"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["otsuka"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07075328","phase":"1/2","setting":"A Phase I/II Study of OJP-001 for Recurrent or Relapsed Adult T-cell Leukemia/Lymphoma Patients With Peripheral Blood Tumor.","sponsor":"Otsuka Medical Devices Co., Ltd. Japan","started":"2024-04-01","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05902988","kind":"trial","name":"A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer","aka":[],"tldr":"A phase 1/2 trial of VLS-1488 in non-small-cell lung cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, ovarian cancer, sarcomas and endometrial cancer, run by Volastra Therapeutics, Inc., now recruiting.","summary":"A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer is a phase 1/2 interventional study registered as NCT05902988 by Volastra Therapeutics, Inc., with 200 participants planned, started 2023-10-18 and due to reach its primary completion in 2026-06. Interventions recorded: VLS-1488.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05902988","url":"https://clinicaltrials.gov/study/NCT05902988"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","tnbc","head-and-neck","ovarian","sarcoma","endometrial"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05902988","phase":"1/2","setting":"A Phase I/II Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced Cancer","sponsor":"Volastra Therapeutics, Inc.","started":"2023-10-18","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06953323","kind":"trial","name":"A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Carboplatin, Nedaplatin, Niraparib, Bevacizumab and Toripalimab in advanced solid tumours, run by Wigen Biomedicine Technology (Shanghai) Co., Ltd., now recruiting.","summary":"A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06953323 by Wigen Biomedicine Technology (Shanghai) Co., Ltd., with 86 participants planned, started 2025-07-10 and due to reach its primary completion in 2029-06-30. Interventions recorded: WJB001 Capsules+Paclitaxel/Paclitaxel-albumin, WJB001 Capsules+carboplatin/Nedaplatin, WJB001 Capsules+Paclitaxel+carboplatin, WJB001 Capsules+Niraparib, WJB001 Capsules+Bevacizumab and WJB001 Capsules+JS207/JS001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06953323","url":"https://clinicaltrials.gov/study/NCT06953323"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["carboplatin","nedaplatin","niraparib","bevacizumab","toripalimab","wjb001"],"companies":["wigen-biomedicine-technology-shanghai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06953323","phase":"1/2","setting":"A Dose-escalation, Dose-expansion and Efficacy Extension Phase I/II Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of WJB001 Combination Therapy in Patients With Advanced Solid Tumors","sponsor":"Wigen Biomedicine Technology (Shanghai) Co., Ltd.","started":"2025-07-10","startedType":"actual","enrolled":86,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04539496","kind":"trial","name":"A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of XZP-3287 and Fulvestrant in advanced solid tumours, run by Sihuan Pharmaceutical Holdings Group Ltd., active and no longer recruiting.","summary":"A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors is a phase 1/2 interventional study registered as NCT04539496 by Sihuan Pharmaceutical Holdings Group Ltd., with 402 participants enrolled, started 2018-05-22 and due to reach its primary completion in 2023-07-31. Interventions recorded: XZP-3287 and XZP-3287;Letrozole;Anastrozole;Fulvestrant.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04539496","url":"https://clinicaltrials.gov/study/NCT04539496"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["xzp-3287","fulvestrant"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04539496","phase":"1/2","setting":"A Multicenter, Open-label Phase I/II Study of XZP-3287 in Metastasis Solid Tumors in China","sponsor":"Sihuan Pharmaceutical Holdings Group Ltd.","started":"2018-05-22","startedType":"actual","enrolled":402,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06084884","kind":"trial","name":"A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma","aka":["ATHENA"],"tldr":"A phase 1/2 trial of AZD5851 in hepatocellular carcinoma, run by AstraZeneca, active and no longer recruiting.","summary":"A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma is a phase 1/2 interventional study registered as NCT06084884 by AstraZeneca, with 94 participants enrolled, started 2023-12-14 and due to reach its primary completion in 2027-12-13. Interventions recorded: AZD5851.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06084884","url":"https://clinicaltrials.gov/study/NCT06084884"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06084884","phase":"1/2","setting":"A Phase I/II Open-Label Study to Evaluate the Safety, Cellular Kinetics and Efficacy of AZD5851, a Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against GPC3 in Adult Participants With Advanced/Recurrent Hepatocellular Carcinoma: ATHENA","sponsor":"AstraZeneca","started":"2023-12-14","startedType":"actual","enrolled":94,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05315167","kind":"trial","name":"A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of PRJ1-3024 in advanced solid tumours, run by Zhuhai Yufan Biotechnologies Co., Ltd, now recruiting.","summary":"A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05315167 by Zhuhai Yufan Biotechnologies Co., Ltd, with 267 participants planned, started 2022-05-30 and due to reach its primary completion in 2027-05-15. Interventions recorded: PRJ1-3024.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05315167","url":"https://clinicaltrials.gov/study/NCT05315167"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["zhuhai-yufan-biotechnologies"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05315167","phase":"1/2","setting":"A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Prime Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors","sponsor":"Zhuhai Yufan Biotechnologies Co., Ltd","started":"2022-05-30","startedType":"actual","enrolled":267,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06380816","kind":"trial","name":"A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer","aka":[],"tldr":"A phase 1/2 trial in triple-negative breast cancer, run by Cancer Research UK, now recruiting.","summary":"A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer is a phase 1/2, interventional study registered as NCT06380816 by Cancer Research UK, with a registry enrolment figure of 167 participants, started 2024-07-09 and due to reach its primary completion in 2029-11. Interventions recorded: UCB4594. Conditions listed: Advanced Solid Tumours; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Triple Negative Breast Neoplasms; Carcinoma, Renal Cell (Clear Cell Only); Esophageal Neoplasms; Stomach Neoplasms (Excluding Gastrointestinal Stromal Tumors); Uterine Cervical Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms. Triple-negative eligibility wording from the registry: \"Module A (dose escalation): Tumour types which have shown high levels of human HLA-G expression (as reported in the literature): head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, renal cell cancer (clear cell only), oesophago-gastric\". Sites: United Kingdom. United Kingdom sites listed: 4. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06380816","url":"https://clinicaltrials.gov/study/NCT06380816"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Guy's Hopsital (London); The Christie NHS Foundation Trust (Manchester); The Newcastle upon Tyne Hospitals NHS Foundation Trust (Newcastle upon Tyne); University Hospital Southampton NHS Foundation Trust (Southampton)."],"nct":"NCT06380816","phase":"1/2","setting":"A Cancer Research UK Phase I/II Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of UCB4594 Alone and in Combination With Anti-cancer Treatments in Participants With Advanced Malignancies","sponsor":"Cancer Research UK","started":"2024-07-09","startedType":"actual","enrolled":167,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06247995","kind":"trial","name":"A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.","aka":["NeoB-Cap1"],"tldr":"A phase 1/2 trial of Capecitabine in advanced solid tumours, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor. is a phase 1/2 interventional study registered as NCT06247995 by Novartis Pharmaceuticals, with 20 participants enrolled, started 2024-08-14 and due to reach its primary completion in 2027-04-14. Interventions recorded: [68Ga]Ga-NeoB, [177Lu]Lu-NeoB and Capecitabine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06247995","url":"https://clinicaltrials.gov/study/NCT06247995"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":["advanced-accelerator-applications"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06247995","phase":"1/2","setting":"A Phase I/II, Open-label, Multi-center Trial of [177Lu]Lu-NeoB in Combination With Capecitabine in Adult Patients With Gastrin Releasing Peptide Receptor Positive, Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.","sponsor":"Novartis Pharmaceuticals","started":"2024-08-14","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05761223","kind":"trial","name":"A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by 1ST Biotherapeutics, Inc., now recruiting.","summary":"A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849 is a phase 1/2 interventional study registered as NCT05761223 by 1ST Biotherapeutics, Inc., with 151 participants planned, started 2023-12-13 and due to reach its primary completion in 2026-06. Interventions recorded: Phase Ia dose-escalation part of FB849 Monotherapy, Phase Ib dose-expansion of FB849 monotherapy, Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab, Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer), Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer) and Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05761223","url":"https://clinicaltrials.gov/study/NCT05761223"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05761223","phase":"1/2","setting":"A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FB849 Administered in Subjects With Advanced Solid Tumors Alone and in Combination With Pembrolizumab","sponsor":"1ST Biotherapeutics, Inc.","started":"2023-12-13","startedType":"actual","enrolled":151,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07362940","kind":"trial","name":"A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib","aka":[],"tldr":"A phase 1/2 trial of GEN-725 tablets + Dositinib mesylate tablets in non-small-cell lung cancer, run by Henan Genuine Biotech Co., Ltd., now recruiting.","summary":"A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib is a phase 1/2 interventional study registered as NCT07362940 by Henan Genuine Biotech Co., Ltd., with 110 participants planned, started 2025-11-27 and due to reach its primary completion in 2027-07-31. Interventions recorded: GEN-725 tablets + Dositinib mesylate tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07362940","url":"https://clinicaltrials.gov/study/NCT07362940"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["henan-genuine-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07362940","phase":"1/2","setting":"A Phase Ⅰ/Ⅱa Clinical Study Evaluating the Efficacy and Safety of GEN-725 in Combination With Dositinib in Patients With Locally Advanced or Metastatic EGFR-Mutant Non-small Cell Lung Cancer","sponsor":"Henan Genuine Biotech Co., Ltd.","started":"2025-11-27","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07811037","kind":"trial","name":"A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Efficacy of SGT003 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SGT003 in advanced solid tumours, run by Beijing Sungen Biomedical Technology Co., Ltd, now recruiting.","summary":"A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Efficacy of SGT003 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07811037 by Beijing Sungen Biomedical Technology Co., Ltd, with 332 participants planned, started 2026-08-17 and due to reach its primary completion in 2028-12. Interventions recorded: SGT003.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07811037","url":"https://clinicaltrials.gov/study/NCT07811037"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07811037","phase":"1/2","setting":"A Multicenter, Dose-Escalation and Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Efficacy of SGT003 in Patients With Advanced Solid Tumors","sponsor":"Beijing Sungen Biomedical Technology Co., Ltd","started":"2026-08-17","startedType":"actual","enrolled":332,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06797986","kind":"trial","name":"A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects With HPV Positive HNSCC.","aka":[],"tldr":"A phase 1/2 trial of BVAC-E6E7 (low level) in head and neck squamous cell carcinoma, run by Cellid Co., Ltd., now recruiting.","summary":"A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects With HPV Positive HNSCC. is a phase 1/2 interventional study registered as NCT06797986 by Cellid Co., Ltd., with 37 participants planned, started 2026-02-04 and due to reach its primary completion in 2027-03. Interventions recorded: BVAC-E6E7 (low level), BVAC-E6E7 (high level) and BVAC-E6E7 (RP2D).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06797986","url":"https://clinicaltrials.gov/study/NCT06797986"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","hpv-positive-oropharyngeal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06797986","phase":"1/2","setting":"A Phase I/IIa Clinical Trial to Investigate the Safety, Immunogenicity and Efficacy of BVAC-E6E7 in Subjects With HPV Type 16 and/or 18 Positive Unresectable Recurrent or Metastatic Head","sponsor":"Cellid Co., Ltd.","started":"2026-02-04","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07392736","kind":"trial","name":"A Phase I/IIa Study of AL8326 Combined With Toripalimab in the Treatment of Advanced Solid Tumors.","aka":[],"tldr":"A phase 1/2 trial of Toripalimab in advanced solid tumours, run by Advenchen Laboratories, LLC, now recruiting.","summary":"A Phase I/IIa Study of AL8326 Combined With Toripalimab in the Treatment of Advanced Solid Tumors. is a phase 1/2 interventional study registered as NCT07392736 by Advenchen Laboratories, LLC, with 228 participants planned, started 2021-10-26 and due to reach its primary completion in 2029-11-07. Interventions recorded: AL8326 tablets and Toripalimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07392736","url":"https://clinicaltrials.gov/study/NCT07392736"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":["advenchen-laboratories"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07392736","phase":"1/2","setting":"A Phase I/IIa Clinical Trial of AL8326 Tablets Combined With Toripalimab in the Treatment of Advanced Recurrent or Metastatic Solid Tumors","sponsor":"Advenchen Laboratories, LLC","started":"2021-10-26","startedType":"actual","enrolled":228,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05123482","kind":"trial","name":"A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies","aka":["BLUESTAR"],"tldr":"A phase 1/2 trial of Puxitatug samrotecan, Rilvegostomig, Saruparib in ovarian cancer and endometrial cancer, run by AstraZeneca, now recruiting.","summary":"A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies is a phase 1/2 interventional study registered as NCT05123482 by AstraZeneca, with 460 participants planned, started 2021-10-18 and due to reach its primary completion in 2027-09-29. Interventions recorded: AZD8205, AZD8205 and AZD2936 (Rilvegostomig), AZD8205 and AZD5305 (saruparib), AZD8205 and AZD5305 (saruparib) and AZD2936 (rilvegostomig), AZD8205 in combination with AZD9574. Conditions listed: Breast Cancer, Biliary Tract Carcinoma, Ovarian Cancer, Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05123482","url":"https://clinicaltrials.gov/study/NCT05123482"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","endometrial","nsclc","sclc"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["puxitatug-samrotecan","rilvegostomig","saruparib","palacaparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05123482","phase":"1/2","setting":"A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)","sponsor":"AstraZeneca","started":"2021-10-18","startedType":"actual","enrolled":460,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07243340","kind":"trial","name":"A Phase I/IIa Study of C5252 in Patients With Intracranial Tumor","aka":[],"tldr":"A phase 1/2 trial of Herpes Virus C5252 Injection in glioma & glioblastoma, run by ImmVira Pharma Co. Ltd, now recruiting.","summary":"A Phase I/IIa Study of C5252 in Patients With Intracranial Tumor is a phase 1/2 interventional study registered as NCT07243340 by ImmVira Pharma Co. Ltd, with 36 participants planned, started 2026-04-03 and due to reach its primary completion in 2027-12-15. Interventions recorded: Herpes Virus C5252 Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07243340","url":"https://clinicaltrials.gov/study/NCT07243340"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["immvira-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07243340","phase":"1/2","setting":"A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Herpes Virus C5252 Injection in Patients With Intracranial Tumor","sponsor":"ImmVira Pharma Co. Ltd","started":"2026-04-03","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04381130","kind":"trial","name":"A Phase I/IIa Study of EF-009 in Patients With Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Everfront Biotech Co., Ltd., not yet recruiting.","summary":"A Phase I/IIa Study of EF-009 in Patients With Pancreatic Cancer is a phase 1/2, interventional study registered as NCT04381130 by Everfront Biotech Co., Ltd., with a registry enrolment figure of 30 participants, started 2027-04-01 and due to reach its primary completion in 2029-12-31. Interventions recorded: EF-009. Conditions listed: Pancreatic Cancer. Primary outcome: Maximum Tolerated Dose (MTD); Overall survival. Pancreatic eligibility wording from the registry: \"Subject has cytological, histological, or pathological confirmation of pancreatic cancer Note: All histologic subtype(s) of exocrine and endocrine pancreatic cancer are eligible to enroll in the study\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04381130","url":"https://clinicaltrials.gov/study/NCT04381130"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04381130","phase":"1/2","setting":"A Phase I/IIa Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety and Efficacy Profile of EF-009 in Patients With Pancreatic Cancer","sponsor":"Everfront Biotech Co., Ltd.","started":"2027-04-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07777211","kind":"trial","name":"A Phase I/IIa Study of GKL-006 Injection in Patients With Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of Gemcitabine in pancreatic ductal adenocarcinoma, run by Beijing Gene Key Life Technology Co., Ltd, active and no longer recruiting.","summary":"A Phase I/IIa Study of GKL-006 Injection in Patients With Advanced Pancreatic Cancer is a phase 1/2 interventional study registered as NCT07777211 by Beijing Gene Key Life Technology Co., Ltd, with 52 participants enrolled, started 2025-08-14 and due to reach its primary completion in 2027-03-31. Interventions recorded: GKL-006 injection and Nab-paclitaxel and Gemcitabine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07777211","url":"https://clinicaltrials.gov/study/NCT07777211"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":["beijing-gene-key-life-technology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07777211","phase":"1/2","setting":"A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of GKL-006 Injection in Patients With Advanced Pancreatic Cancer","sponsor":"Beijing Gene Key Life Technology Co., Ltd","started":"2025-08-14","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07228247","kind":"trial","name":"A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of HMPL-A251 in advanced solid tumours, run by Hutchmed, now recruiting.","summary":"A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors is a phase 1/2 interventional study registered as NCT07228247 by Hutchmed, with 147 participants planned, started 2025-12-16 and due to reach its primary completion in 2028-11-30. Interventions recorded: HMPL-A251.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07228247","url":"https://clinicaltrials.gov/study/NCT07228247"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07228247","phase":"1/2","setting":"A Phase Ⅰ/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A251 in Participants With Advanced or Metastatic HER2-Expressing Solid Tumors","sponsor":"Hutchmed","started":"2025-12-16","startedType":"actual","enrolled":147,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06959615","kind":"trial","name":"A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration","aka":[],"tldr":"A phase 1/2 trial of JAB-23E73 in advanced solid tumours, run by Jacobio Pharmaceuticals Co., Ltd., now recruiting.","summary":"A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration is a phase 1/2 interventional study registered as NCT06959615 by Jacobio Pharmaceuticals Co., Ltd., with 334 participants planned, started 2024-11-22 and due to reach its primary completion in 2026-12-31. Interventions recorded: JAB-23E73.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06959615","url":"https://clinicaltrials.gov/study/NCT06959615"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["jacobio-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06959615","phase":"1/2","setting":"A Multicenter, Open Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration","sponsor":"Jacobio Pharmaceuticals Co., Ltd.","started":"2024-11-22","startedType":"actual","enrolled":334,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07744763","kind":"trial","name":"A Phase I/IIa Study of SYS6041 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Farletuzumab-exatecan in advanced solid tumours, run by CSPC Megalith Biopharmaceutical Co.,Ltd., now recruiting.","summary":"A Phase I/IIa Study of SYS6041 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07744763 by CSPC Megalith Biopharmaceutical Co.,Ltd., with 260 participants planned, started 2025-03-28 and due to reach its primary completion in 2027-03-28. Interventions recorded: SYS6041.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07744763","url":"https://clinicaltrials.gov/study/NCT07744763"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["farletuzumab-exatecan"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07744763","phase":"1/2","setting":"A Multicenter, Open-label, Dose-escalation and Dose-expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Antitumor Activity of SYS6041 in Patients With Advanced Solid Tumors","sponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","started":"2025-03-28","startedType":"actual","enrolled":260,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06727630","kind":"trial","name":"A Phase Ib Study of PRJ1-3024 for Treatment of Advanced or Metastatic Melanoma","aka":[],"tldr":"A phase 1/2 trial of PRJ1-3024 in melanoma, run by Zhuhai Yufan Biotechnologies Co., Ltd, now recruiting.","summary":"A Phase Ib Study of PRJ1-3024 for Treatment of Advanced or Metastatic Melanoma is a phase 1/2 interventional study registered as NCT06727630 by Zhuhai Yufan Biotechnologies Co., Ltd, with 40 participants planned, started 2024-03-14 and due to reach its primary completion in 2025-04-30. Interventions recorded: PRJ1-3024.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06727630","url":"https://clinicaltrials.gov/study/NCT06727630"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["zhuhai-yufan-biotechnologies"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06727630","phase":"1/2","setting":"A Phase Ib Study, Evaluating the Safety, Tolerance and Efficacy of PRJ1-3024 Capsules in China Subjects with Unresectable Local Advanced or Metastatic Melanoma","sponsor":"Zhuhai Yufan Biotechnologies Co., Ltd","started":"2024-03-14","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05951608","kind":"trial","name":"A Phase Ib/II Clinical Study of AK127 in Combination With AK112 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of AK127 in combination with AK112 in advanced solid tumours, run by Akeso, active and no longer recruiting.","summary":"A Phase Ib/II Clinical Study of AK127 in Combination With AK112 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05951608 by Akeso, with 216 participants enrolled, started 2023-10-16 and due to reach its primary completion in 2026-05-01. Interventions recorded: AK127 in combination with AK112.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05951608","url":"https://clinicaltrials.gov/study/NCT05951608"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05951608","phase":"1/2","setting":"A Phase Ib/II Open-label Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AK127 in Combination With AK112 in Patients With Advanced Malignant Tumors","sponsor":"Akeso","started":"2023-10-16","startedType":"actual","enrolled":216,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05133882","kind":"trial","name":"A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML","aka":[],"tldr":"A phase 1/2 trial of Clifutinib in acute myeloid leukaemia, run by Sunshine Lake Pharma Co., Ltd., now recruiting.","summary":"A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML is a phase 1/2 interventional study registered as NCT05133882 by Sunshine Lake Pharma Co., Ltd., with 133 participants planned, started 2022-10-31 and due to reach its primary completion in 2027-12-31. Interventions recorded: Clifutinib Besylate.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05133882","url":"https://clinicaltrials.gov/study/NCT05133882"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":["clifutinib"],"companies":["sunshine-lake-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05133882","phase":"1/2","setting":"A Phase Ib/II, Multi-center, Open Clinical Trial of Crifortinib Besylate Combined With Chemotherapy in Newly-treated Adult Subjects With Acute Myeloid Leukemia","sponsor":"Sunshine Lake Pharma Co., Ltd.","started":"2022-10-31","startedType":"actual","enrolled":133,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07040228","kind":"trial","name":"A Phase Ib/II Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of regorafenib and toripalimab in pancreatic cancer, run by Junjie Hang, now recruiting.","summary":"A Phase Ib/II Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer is a phase 1/2, interventional study registered as NCT07040228 by Junjie Hang, with a registry enrolment figure of 23 participants, started 2025-05-26 and due to reach its primary completion in 2027-05-30. Interventions recorded: Regorafenib combined with Toripalimab and Albumin paclitaxel. Conditions listed: Pancreatic Cancer Metastatic. Primary outcome: (PFS). Pancreatic eligibility wording from the registry: \"Patients with unresectable/metastatic pancreatic cancer confirmed by histopathology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07040228","url":"https://clinicaltrials.gov/study/NCT07040228"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["regorafenib","toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07040228","phase":"1/2","setting":"A Phase Ib/II Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer","sponsor":"Junjie Hang","started":"2025-05-26","startedType":"actual","enrolled":23,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06474455","kind":"trial","name":"A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SHR-A1921, SHR-A2009, Aumolertinib, Pemetrexed, Carboplatin and Adebrelimab in advanced solid tumours, run by Shanghai Hengrui Pharmaceutical Co., Ltd., now recruiting.","summary":"A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06474455 by Shanghai Hengrui Pharmaceutical Co., Ltd., with 156 participants planned, started 2024-07-02 and due to reach its primary completion in 2029-06. Interventions recorded: SHR-9839 for Injection, SHR-A1921 for Injection, SHR-A2009 for Injection, Almonertinib Mesilate Tablets, Pemetrexed Disodium for Injection and Carboplatin for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06474455","url":"https://clinicaltrials.gov/study/NCT06474455"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-a1921","shr-a2009","aumolertinib","pemetrexed","carboplatin","adebrelimab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06474455","phase":"1/2","setting":"A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-9839 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2024-07-02","startedType":"actual","enrolled":156,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05846867","kind":"trial","name":"A Phase Ib/II Clinical Study on AK112 Combined or Not Combined With AK119 in pMMR/MSS Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of AK119, Ivonescimab, CAPOX in colorectal cancer, run by Akeso, active and no longer recruiting.","summary":"A Phase Ib/II Clinical Study on AK112 Combined or Not Combined With AK119 in pMMR/MSS Colorectal Cancer is a phase 1/2 interventional study registered as NCT05846867 by Akeso, with 170 participants planned, started 2023-05-08 and due to reach its primary completion in 2026-05-08. Interventions recorded: AK119, AK112, Oxaliplatin, Irinotecan, Calcium folinate. Conditions listed: Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05846867","url":"https://clinicaltrials.gov/study/NCT05846867"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["ak119","ivonescimab","capox","folfiri","leucovorin","fluorouracil"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05846867","phase":"1/2","setting":"An Open, Multicenter Phase Ib/II Clinical Study on the Efficacy and Safety of AK119 and AK112, Either in Combination or Not, With Chemotherapy, and AK112 Monotherapy in pMMR/MSS CRC","sponsor":"Akeso","started":"2023-05-08","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06848699","kind":"trial","name":"A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Serplulimab in non-small-cell lung cancer and small-cell lung cancer, run by Shanghai Henlius Biotech, now recruiting.","summary":"A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06848699 by Shanghai Henlius Biotech, with 105 participants planned, started 2025-02-25 and due to reach its primary completion in 2026-10-30. Interventions recorded: HLX43 dose 1, HLX43 dose 2, HLX43 dose 3, HLX43 dose 4, HLX43 dose 5. Conditions listed: Solid Tumor Cancer, Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06848699","url":"https://clinicaltrials.gov/study/NCT06848699"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["serplulimab"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06848699","phase":"1/2","setting":"A Phase Ib/ II Clinical Study to Evaluate the Safety ,Torlerbility , and Efficacy of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab (Anti-PD-1 Humanized Monocl ) in Patients With Advanced/Metastatic Solid Tumors","sponsor":"Shanghai Henlius Biotech","started":"2025-02-25","startedType":"actual","enrolled":105,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05543330","kind":"trial","name":"A Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC","aka":[],"tldr":"A phase 1/2 trial of Cisplatin in non-small-cell lung cancer, run by Wuhan YZY Biopharma Co., Ltd., now recruiting.","summary":"A Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC is a phase 1/2 interventional study registered as NCT05543330 by Wuhan YZY Biopharma Co., Ltd., with 116 participants planned, started 2022-09-30 and due to reach its primary completion in 2026-09-15. Interventions recorded: M701 pleural infusion, Pleural drainage and Cisplatin pleural infusion.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05543330","url":"https://clinicaltrials.gov/study/NCT05543330"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin"],"companies":["wuhan-yzy-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05543330","phase":"1/2","setting":"A Phase 1, Multicenter, Open-label, Dose-increasing Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of M701, a Recombinant Epcam and CD3 Bispecific Antibody , in Patients With Malignant Pleural Effusions Caused by NSCLC","sponsor":"Wuhan YZY Biopharma Co., Ltd.","started":"2022-09-30","startedType":"actual","enrolled":116,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07501559","kind":"trial","name":"A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of JL15003 Injection in Patients With Recurrent Glioblastoma (rGBM)","aka":[],"tldr":"A phase 1/2 trial of JL15003Injection in glioma & glioblastoma, run by Jecho Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of JL15003 Injection in Patients With Recurrent Glioblastoma (rGBM) is a phase 1/2 interventional study registered as NCT07501559 by Jecho Biopharmaceuticals Co., Ltd., with 40 participants planned, started 2026-06-17 and due to reach its primary completion in 2030-04. Interventions recorded: JL15003Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07501559","url":"https://clinicaltrials.gov/study/NCT07501559"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07501559","phase":"1/2","setting":"A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of JL15003 Injection in Patients With Recurrent Glioblastoma (rGBM)","sponsor":"Jecho Biopharmaceuticals Co., Ltd.","started":"2026-06-17","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07226986","kind":"trial","name":"A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA","aka":[],"tldr":"A phase 1/2 trial of Enzalutamide, Abiraterone acetate in prostate cancer, run by Novartis Pharmaceuticals, now recruiting.","summary":"A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC is a phase 1/2 interventional study registered as NCT07226986 by Novartis Pharmaceuticals, with 123 participants planned, started 2025-12-05 and due to reach its primary completion in 2028-07-10. Interventions recorded: AMO959, AAA617, Enzalutamide, Abiraterone. Conditions listed: PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07226986","url":"https://clinicaltrials.gov/study/NCT07226986"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["enzalutamide","abiraterone","amo959"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07226986","phase":"1/2","setting":"A Phase Ib/II Open-label, Multi-center Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With an Androgen Receptor Pathway Inhibitor (ARPI) in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)","sponsor":"Novartis Pharmaceuticals","started":"2025-12-05","startedType":"actual","enrolled":123,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07466160","kind":"trial","name":"A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Cisplatin and Carboplatin in advanced solid tumours, run by Mabwell (Shanghai) Bioscience Co., Ltd., now recruiting.","summary":"A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07466160 by Mabwell (Shanghai) Bioscience Co., Ltd., with 280 participants planned, started 2026-02-11 and due to reach its primary completion in 2027-12-31. Interventions recorded: 7MW3711, JS207, Cisplatin and Carboplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07466160","url":"https://clinicaltrials.gov/study/NCT07466160"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cisplatin","carboplatin"],"companies":["mabwell-shanghai-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07466160","phase":"1/2","setting":"A Multi-center, Open-label, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of 7MW3711 in Combination With JS207 With or Without Chemotheray in Patients With Advanced Solid Tumors","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","started":"2026-02-11","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05229497","kind":"trial","name":"A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors","aka":[],"tldr":"A phase 1/2 trial of AK117, Carboplatin, Cisplatin and Gemcitabine in advanced solid tumours, run by Akeso, active and no longer recruiting.","summary":"A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors is a phase 1/2 interventional study registered as NCT05229497 by Akeso, with 154 participants enrolled, started 2022-05-04 and due to reach its primary completion in 2026-12-31. Interventions recorded: AK112, AK117, Carboplatin, Cisplatin, 5-Fluorouracil and Gemcitabine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05229497","url":"https://clinicaltrials.gov/study/NCT05229497"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ak117","carboplatin","cisplatin","gemcitabine"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05229497","phase":"1/2","setting":"A Phase Ib/II Study of AK112#PD-1/VEGF Bispecific Antibody# in Combination With AK117#Anti-CD47 Antibody# in Advanced Malignant Tumors","sponsor":"Akeso","started":"2022-05-04","startedType":"actual","enrolled":154,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05910827","kind":"trial","name":"A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers","aka":[],"tldr":"A phase 1/2 trial of HMBD-001, Docetaxel, Cetuximab in non-small-cell lung cancer and small-cell lung cancer, run by Hummingbird Bioscience, now recruiting.","summary":"A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers is a phase 1/2 interventional study registered as NCT05910827 by Hummingbird Bioscience, with 398 participants planned, started 2024-02-05 and due to reach its primary completion in 2027-12-01. Interventions recorded: HMBD-001, Docetaxel, Cetuximab. Conditions listed: Advanced or Metastatic Squamous Non-Small Cell Lung Cancer, Advanced Head and Neck Squamous Cell Carcinoma, Advanced Esophageal Squamous Cell Carcinoma, Cervical Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05910827","url":"https://clinicaltrials.gov/study/NCT05910827"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","head-and-neck","cutaneous-scc"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["hmbd-001","docetaxel","cetuximab"],"companies":["hummingbird-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05910827","phase":"1/2","setting":"A Phase Ib/II Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas","sponsor":"Hummingbird Bioscience","started":"2024-02-05","startedType":"actual","enrolled":398,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07621159","kind":"trial","name":"A Phase Ib/II Study of HDM2017 in Combination With Standard of Care in Advanced Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of HDM2017 and fruquintinib in colorectal cancer, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., not yet recruiting.","summary":"A Phase Ib/II Study of HDM2017 in Combination With Standard of Care in Advanced Colorectal Cancer is a phase 1/2, interventional study registered as NCT07621159 by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., with a registry enrolment figure of 120 participants, started 2026-07-15 and due to reach its primary completion in 2027-11-01. Interventions recorded: HDM2017; Fruquintinib. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Maximum Tolerated Dose (MTD); Recommended Phase 2 Dose (RP2D); Type, incidence and severity of Adverse Events. Colorectal eligibility wording from the registry: \"Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07621159","url":"https://clinicaltrials.gov/study/NCT07621159"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["hdm2017","fruquintinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07621159","phase":"1/2","setting":"A Phase Ib/II Clinical Study to Evaluate the Preliminary Efficacy and Safety of HDM2017 in Combination With Standard of Care in Participants With Advanced Colorectal Cancer","sponsor":"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","started":"2026-07-15","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07750041","kind":"trial","name":"A Phase Ib/II Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of bevacizumab (glioblastoma use) and regorafenib in colorectal cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd., not yet recruiting.","summary":"A Phase Ib/II Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer is a phase 1/2, randomised interventional study registered as NCT07750041 by CSPC Megalith Biopharmaceutical Co.,Ltd., with a registry enrolment figure of 260 participants, started 2026-08-30 and due to reach its primary completion in 2027-12-31. Interventions recorded: SYS6090 (Fixed Dose Level A) + bevacizumab; SYS6090 (Fixed Dose Level B ) + bevacizumab; SYS6090 RP2D + bevacizumab +mFOLFOX6; SYS6090 RP2D + bevacizumab; Regorafenib; SYS6090 PR2D+ bevacizumab + FOLFOXIRI; bevacizumab + FOLFOXIRI. Conditions listed: Unresectable Advanced or Metastatic Colorectal Cancer. Primary outcome: Recommended Phase 2 Dose (RP2D), Safety and Tolerability; Objective Response Rate (ORR) assessed per RECIST v1.1; Progression-Free Survival (PFS) assessed per RECIST v1.1. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed unresectable advanced or metastatic colorectal cancer with pMMR/MSS status, assigned to corresponding cohorts as follows:\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07750041","url":"https://clinicaltrials.gov/study/NCT07750041"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["bevacizumab-glioma","regorafenib"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07750041","phase":"1/2","setting":"A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Efficacy of SYS6090 in Combination With Other Therapies in Participants With Advanced Coloretal Cancer","sponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","started":"2026-08-30","startedType":"estimated","enrolled":260,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07358585","kind":"trial","name":"A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of serplulimab in colorectal cancer, run by Shanghai Henlius Biotech, not yet recruiting.","summary":"A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer is a phase 1/2, randomised interventional study registered as NCT07358585 by Shanghai Henlius Biotech, with a registry enrolment figure of 126 participants, started 2026-01-31 and due to reach its primary completion in 2027-07-28. Interventions recorded: HLX43 dose 1 + HLX07; HLX43 dose 2 + HLX07; HLX43 dose 3 + Serplulimab; HLX43 dose 4 + Serplulimab. Conditions listed: Colon Cancer Adenocarcinoma. Primary outcome: ORR; PFS. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed advanced or metastatic colorectal adenocarcinoma; and locally tested and confirmed as a RAS/BRAF wild-type tumor (only for Part 1 );\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07358585","url":"https://clinicaltrials.gov/study/NCT07358585"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["serplulimab"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07358585","phase":"1/2","setting":"A Phase Ib/II Study to Evaluate the Efficacy, Safety and Tolerance of HLX43 (an Anti-PD-L1 Antibody Conjugated) Combined With HLX07 (a Recombinant Anti-EGFR Humanized Monoclonal Antibody) or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer","sponsor":"Shanghai Henlius Biotech","started":"2026-01-31","startedType":"estimated","enrolled":126,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07002177","kind":"trial","name":"A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC","aka":[],"tldr":"A phase 1/2 trial of Palbociclib, Ribociclib, Abemaciclib and Everolimus in advanced solid tumours, run by Forward Pharmaceuticals Co., Ltd., now recruiting.","summary":"A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC is a phase 1/2 interventional study registered as NCT07002177 by Forward Pharmaceuticals Co., Ltd., with 196 participants planned, started 2025-06-01 and due to reach its primary completion in 2028-05-01. Interventions recorded: FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet, Abemaciclib 150 MG and Everolimus 10 mg.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07002177","url":"https://clinicaltrials.gov/study/NCT07002177"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["palbociclib","ribociclib","abemaciclib","everolimus"],"companies":["forward-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07002177","phase":"1/2","setting":"An Open-label, Multicenter, Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of Multiple Combination Therapies With FWD1802 in Subjects With ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer","sponsor":"Forward Pharmaceuticals Co., Ltd.","started":"2025-06-01","startedType":"actual","enrolled":196,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07283367","kind":"trial","name":"A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.","aka":[],"tldr":"A phase 1/2 trial of Bevacizumab, Oxaliplatin and Capecitabine in colorectal cancer, run by Hansoh BioMedical R&D Company, now recruiting.","summary":"A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients. is a phase 1/2 interventional study registered as NCT07283367 by Hansoh BioMedical R&D Company, with 502 participants planned, started 2025-12-22 and due to reach its primary completion in 2029-12-31. Interventions recorded: Cohort 1: HS-20110+ Bevacizumab+5-FU/leucovorin, Cohort 2: HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorin and Cohort 3: HS-20110+Bevacizumab+Oxaliplatin+Capecitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07283367","url":"https://clinicaltrials.gov/study/NCT07283367"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab","oxaliplatin","capecitabine"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07283367","phase":"1/2","setting":"A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20110 Combination Therapies in Patients With Advanced Colorectal Cancer.","sponsor":"Hansoh BioMedical R&D Company","started":"2025-12-22","startedType":"actual","enrolled":502,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07547553","kind":"trial","name":"A Phase Ib/II Trial to Evaluate the Efficacy and Safety of HH-009 for the Treatment of FGF19-positive Advanced or Unresectable HCC","aka":[],"tldr":"A phase 1/2 trial of Will receive HH-009 injection 20 mg/kg, Q3W in hepatocellular carcinoma, run by Huahui Health, now recruiting.","summary":"A Phase Ib/II Trial to Evaluate the Efficacy and Safety of HH-009 for the Treatment of FGF19-positive Advanced or Unresectable HCC is a phase 1/2 interventional study registered as NCT07547553 by Huahui Health, with 30 participants planned, started 2026-05-19 and due to reach its primary completion in 2028-10-30. Interventions recorded: Will receive HH-009 injection 20 mg/kg, Q3W and Will receive HH-009 injection 30 mg/kg, Q3W.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07547553","url":"https://clinicaltrials.gov/study/NCT07547553"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07547553","phase":"1/2","setting":"A Randomized, Open-Label, Multicenter, Phase Ib/II Registration Trial to Observe and Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HH-009 Injection in FGF19-Positive Participants With Advanced or Unresectable Hepatocellular Carcinoma (HCC) Who Have Experienced Progressive Disease After Prior Systemic Therapy","sponsor":"Huahui Health","started":"2026-05-19","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07361003","kind":"trial","name":"A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 3 trial of Trifluridine/tipiracil in colorectal cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd., now recruiting.","summary":"A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer is a phase 3 interventional study registered as NCT07361003 by Jiangsu Simcere Pharmaceutical Co., Ltd., with 464 participants planned, started 2025-11-12 and due to reach its primary completion in 2028-01. Interventions recorded: Suvemcitug injection, trifluridine/tipiracil tablets, Suvemcitug placebo injection, trifluridine/tipiracil tablets. Conditions listed: Refractory Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07361003","url":"https://clinicaltrials.gov/study/NCT07361003"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["trifluridine-tipiracil"],"companies":["simcere"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07361003","phase":"3","setting":"A Phase Ib/III Study of Suvemcitug Plus Trifluridine/Tipiracil Tablets (FTD/TPI) Versus Placebo Plus Trifluridine/Tipiracil Tablets in Participants With Refractory Metastatic Colorectal Cancer","sponsor":"Jiangsu Simcere Pharmaceutical Co., Ltd.","started":"2025-11-12","startedType":"actual","enrolled":464,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07233850","kind":"trial","name":"A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestinal Cancers","aka":[],"tldr":"A phase 2 trial of SSGJ-706, cAPOX (capecitabine, oxaliplatin) and bevacizumab in pancreatic cancer, run by Shenyang Sunshine Pharmaceutical Co., LTD., not yet recruiting.","summary":"A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestinal Cancers is a phase 2, interventional study registered as NCT07233850 by Shenyang Sunshine Pharmaceutical Co., LTD., with a registry enrolment figure of 300 participants, started 2025-11 and due to reach its primary completion in 2026-12. Interventions recorded: SSGJ-706+XELOX; SSGJ-706+Bevacizumab+XELOX; SSGJ-706+AG; SSGJ-706+TP. Conditions listed: Gastric/Gastroesophageal Junction Adenocarcinoma; Metastatic Colorectal Cancer (CRC); Pancreatic Ductal Adenocarcinoma (PDAC); Oesophageal Cancer. Primary outcome: Incidence and severity of Adverse Events; Objective response rate (ORR). Pancreatic eligibility wording from the registry: \"Locally advanced or metastatic tumors of the digestive system that cannot be curatively resected and cannot be treated with radical chemoradiotherapy, including gastric/gastroesophageal junction adenocarcinoma, colorectal cancer, pancreatic ductal adenocarcinoma, and oesophageal cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07233850","url":"https://clinicaltrials.gov/study/NCT07233850"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac","locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["ssgj-706","capox","bevacizumab"],"companies":["3sbio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07233850","phase":"2","setting":"A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestinal Cancers","sponsor":"Shenyang Sunshine Pharmaceutical Co., LTD.","started":"2025-11","startedType":"estimated","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06177925","kind":"trial","name":"A Phase II Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC","aka":[],"tldr":"A phase 2 trial of adebrelimab, carboplatin, cisplatin and etoposide in lung cancer, run by Nanfang Hospital, Southern Medical University, now recruiting.","summary":"A Phase II Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC is a phase 2, interventional study registered as NCT06177925 by Nanfang Hospital, Southern Medical University, with a registry enrolment figure of 62 participants, started 2023-12-10 and due to reach its primary completion in 2026-06-30. Interventions recorded: Adebrelimab; Carboplatin/Cisplatin; Etoposide; Radiation therapy. Conditions listed: Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma. Primary outcome: Progression-Free Survival (PFS). Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \\[VALG\\] staging system)，the number of metastatic lesions ≤ 5, the number of metastatic organs ≤ 3, and no previous systemic chemotherapy, radiotherapy or immune checkpoint inhibitor treatment\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06177925","url":"https://clinicaltrials.gov/study/NCT06177925"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["adebrelimab","carboplatin","cisplatin","etoposide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06177925","phase":"2","setting":"A Phase II Exploratory Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy as First-Line Treatment for Extensive-Stage Oligometastatic Small Cell Lung Cancer","sponsor":"Nanfang Hospital, Southern Medical University","started":"2023-12-10","startedType":"estimated","enrolled":62,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07229872","kind":"trial","name":"A Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Fruquintinib in the Treatment of Immunodominant pMMR/MSS Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of fruquintinib in colorectal cancer, run by Harbin Medical University, not yet recruiting.","summary":"A Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Fruquintinib in the Treatment of Immunodominant pMMR/MSS Metastatic Colorectal Cancer That Has Failed Second-line or Above Treatment is a phase 2, interventional study registered as NCT07229872 by Harbin Medical University, with a registry enrolment figure of 18 participants, started 2025-12 and due to reach its primary completion in 2026-12. Interventions recorded: Aipalolitovorelizumab; Fruquintinib. Conditions listed: Colorectal Cancer. Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"Patients must be pathologically confirmed as advanced, metastatic or recurrent microsatellite stable (MSS) colorectal cancer (detected by immunohistochemistry, PCR or NGS according to the detection standards of each institutional testing center);\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07229872","url":"https://clinicaltrials.gov/study/NCT07229872"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07229872","phase":"2","setting":"A Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Fruquintinib in the Treatment of Immunodominant pMMR/MSS Metastatic Colorectal Cancer That Has Failed Second-line or Above Treatment","sponsor":"Harbin Medical University","started":"2025-12","startedType":"estimated","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07052253","kind":"trial","name":"A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.","aka":[],"tldr":"A phase 2 trial of Tinengotinib, Cadonilimab, Ivonescimab in hepatocellular carcinoma, run by Akeso, now recruiting.","summary":"A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC. is a phase 2 interventional study registered as NCT07052253 by Akeso, with 100 participants planned, started 2025-07-18 and due to reach its primary completion in 2027-05-10. Interventions recorded: TT-00420 (tinengotinib), AK104, AK112. Conditions listed: Hepatocellular Carcinoma (HCC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07052253","url":"https://clinicaltrials.gov/study/NCT07052253"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["tinengotinib","cadonilimab","ivonescimab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07052253","phase":"2","setting":"An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet in Patients With Advanced Hepatocellular Carcinoma.","sponsor":"Akeso","started":"2025-07-18","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07241767","kind":"trial","name":"A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer","aka":[],"tldr":"A phase 2 trial of Adebrelimab, Carboplatin, Cisplatin and SHR-8068 in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer is a phase 2 interventional study registered as NCT07241767 by Jiangsu HengRui Medicine Co., Ltd., with 200 participants planned, started 2025-11-12 and due to reach its primary completion in 2027-11. Interventions recorded: FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin, FH-006 ; SHR-1316 ; BP102 and FH-006; SHR-1316 ; SHR-8068.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07241767","url":"https://clinicaltrials.gov/study/NCT07241767"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["adebrelimab","carboplatin","cisplatin","shr-8068"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07241767","phase":"2","setting":"An Open Label, Multicenter Phase II Clinical Study on the Safety, Tolerability, and Efficacy of FH-006 Injection Combined With Other Anti-tumor Therapies in Lung Cancer Subjects","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-11-12","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06915142","kind":"trial","name":"A Phase II Clinical Study of HRS-7058 in Combination With Antitumor Drugs in Patients With Advanced Malignant Tumour","aka":[],"tldr":"A phase 2 trial of Adebrelimab, Cetuximab and SHR-A2102 in advanced solid tumours, run by Shandong Suncadia Medicine Co., Ltd., now recruiting.","summary":"A Phase II Clinical Study of HRS-7058 in Combination With Antitumor Drugs in Patients With Advanced Malignant Tumour is a phase 2 interventional study registered as NCT06915142 by Shandong Suncadia Medicine Co., Ltd., with 300 participants planned, started 2025-04-28 and due to reach its primary completion in 2026-12. Interventions recorded: HRS-7058 + SHR-1316, HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy, HRS-7058 + Cetuximab, HRS-7058 + SHR-1826, HRS-7058 + SHR-1826 + SHR-1316 and HRS-7058 + SHR-A1202.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06915142","url":"https://clinicaltrials.gov/study/NCT06915142"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["adebrelimab","cetuximab","shr-a2102"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06915142","phase":"2","setting":"An Phase II Clinical Study on the Safety, Tolerability and Efficacy of HRS-7058 in Combination With Antitumor Drugs in Subjects With Solid Tumors","sponsor":"Shandong Suncadia Medicine Co., Ltd.","started":"2025-04-28","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07331155","kind":"trial","name":"A Phase II Clinical Study of LBL-024 Combination Therapy in Patients With Advanced Solid Tumour[Substudy 03(ESCC)]","aka":[],"tldr":"A phase 2 trial of Cisplatin, Tislelizumab and Capecitabine in advanced solid tumours, run by Nanjing Leads Biolabs Co.,Ltd, now recruiting.","summary":"A Phase II Clinical Study of LBL-024 Combination Therapy in Patients With Advanced Solid Tumour[Substudy 03(ESCC)] is a phase 2 interventional study registered as NCT07331155 by Nanjing Leads Biolabs Co.,Ltd, with 110 participants planned, started 2026-02-26 and due to reach its primary completion in 2028-12-26. Interventions recorded: LBL-024 for Injection, Cisplatin Injection, Paclitaxel Injection, Tislelizumab Injection, 5-Fluorouracil injection and Capecitabine tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07331155","url":"https://clinicaltrials.gov/study/NCT07331155"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cisplatin","tislelizumab","capecitabine"],"companies":["nanjing-leads-biolabs"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07331155","phase":"2","setting":"An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour[Substudy Number 03(ESCC)]","sponsor":"Nanjing Leads Biolabs Co.,Ltd","started":"2026-02-26","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06889610","kind":"trial","name":"A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Fudan University, now recruiting.","summary":"A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors. is a phase 2, interventional study registered as NCT06889610 by Fudan University, with a registry enrolment figure of 95 participants, started 2026-03-30 and due to reach its primary completion in 2027-12-30. Interventions recorded: MTT(Multimodal Tumor Thermal Therapy System)- Colorectal Cancer; MTT(Multimodal Tumor Thermal Therapy System)- Triple-Negative Breast Cancer; MTT(Multimodal Tumor Thermal Therapy System)- Melanoma. Conditions listed: Triple Negative Breast Cancer Metastatic; Melanoma Metastatic; Colorectal Cancer Metastatic. Triple-negative eligibility wording from the registry: \"Triple-negative breast cancer :\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06889610","url":"https://clinicaltrials.gov/study/NCT06889610"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06889610","phase":"2","setting":"A Single-center,Multi-cohort,Prospective Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.","sponsor":"Fudan University","started":"2026-03-30","startedType":"actual","enrolled":95,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07798947","kind":"trial","name":"A Phase II Clinical Study of SHR-7787 Injection Combined With SHR-1316 Injection in Patients With LS-SCLC","aka":[],"tldr":"A phase 2 trial of adebrelimab in lung cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd., not yet recruiting.","summary":"A Phase II Clinical Study of SHR-7787 Injection Combined With SHR-1316 Injection in Patients With LS-SCLC is a phase 2, interventional study registered as NCT07798947 by Shanghai Hengrui Pharmaceutical Co., Ltd., with a registry enrolment figure of 120 participants, started 2026-09 and due to reach its primary completion in 2028-12. Interventions recorded: SHR-7787 Injection; SHR-1316. Conditions listed: Limited-stage Small-cell Lung Cancer. Primary outcome: Incidence and severity of adverse events (AEs); Incidence and severity of serious adverse events (SAEs); Progression-Free Survival (PFS). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed unresectable limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemotherapy and radiation therapy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07798947","url":"https://clinicaltrials.gov/study/NCT07798947"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["limited-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07798947","phase":"2","setting":"A Multicenter, Open-label, Phase II Clinical Study of SHR-7787 Injection Combined With Adebrelimab in Patients With Limited Stage Small Cell Lung Cancer","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2026-09","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07308106","kind":"trial","name":"A Phase II Clinical Study of SKB571 as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities","aka":[],"tldr":"A phase 2 trial of SKB571 for injection in advanced solid tumours, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"A Phase II Clinical Study of SKB571 as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities is a phase 2 interventional study registered as NCT07308106 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 70 participants planned, started 2026-04-03 and due to reach its primary completion in 2027-06-30. Interventions recorded: SKB571 for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07308106","url":"https://clinicaltrials.gov/study/NCT07308106"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07308106","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Safety and Efficacy of SKB571 for Injection as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-04-03","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06218888","kind":"trial","name":"A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Micro","aka":[],"tldr":"A phase 2 trial of tislelizumab, fruquintinib and tucidinostat (chidamide) in colorectal cancer, run by Fujian Cancer Hospital, not yet recruiting.","summary":"A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Microsatellite Stabilized (MSS/pMMR) Colorectal Cancer With Liver Metastases is a phase 2, interventional study registered as NCT06218888 by Fujian Cancer Hospital, with a registry enrolment figure of 17 participants, started 2024-06-01 and due to reach its primary completion in 2025-12-01. Interventions recorded: Tislelizumab; Fruquintinib; Chidamide. Conditions listed: Colo-rectal Cancer. Primary outcome: Objective Response Rate（ORR）. Colorectal eligibility wording from the registry: \"* Subjects with histologically and/or cytologically confirmed locally advanced unresectable or metastatic colorectal adenocarcinoma with liver metastasis (excluding adenosquamous carcinoma mixed with other pathological types)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06218888","url":"https://clinicaltrials.gov/study/NCT06218888"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["tislelizumab","fruquintinib","tucidinostat"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06218888","phase":"2","setting":"A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Microsatellite Stabilized (MSS/pMMR) Colorectal Cancer With Liver Metastases","sponsor":"Fujian Cancer Hospital","started":"2024-06-01","startedType":"estimated","enrolled":17,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07253142","kind":"trial","name":"A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer","aka":[],"tldr":"A phase 2 trial of Serplulimab in non-small-cell lung cancer and small-cell lung cancer, run by Shanghai Henlius Biotech, now recruiting.","summary":"A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer is a phase 2 interventional study registered as NCT07253142 by Shanghai Henlius Biotech, with 120 participants planned, started 2026-02-05 and due to reach its primary completion in 2027-06-18. Interventions recorded: HLX43 dose 1, HLX43 dose 2. Conditions listed: Non Small Cell Lung Cancer, Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07253142","url":"https://clinicaltrials.gov/study/NCT07253142"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["serplulimab"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07253142","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab (Humanized Anti-PD-1 Monoclonal Antibody Injection) in Advanced Stage Lung Cancer","sponsor":"Shanghai Henlius Biotech","started":"2026-02-05","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06742892","kind":"trial","name":"A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy","aka":[],"tldr":"A phase 2 trial of HLX43 DOSE 1 in hepatocellular carcinoma, run by Shanghai Henlius Biotech, now recruiting.","summary":"A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy is a phase 2 interventional study registered as NCT06742892 by Shanghai Henlius Biotech, with 90 participants planned, started 2025-03-03 and due to reach its primary completion in 2026-10-31. Interventions recorded: HLX43 DOSE 1, HLX43 DOSE 2 and HLX43 DOSE 3.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06742892","url":"https://clinicaltrials.gov/study/NCT06742892"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06742892","phase":"2","setting":"A Phase II Clinical Study to Evaluate HLX43 (Anti-PD-L1 ADC) in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed or Intolerance to Standard Therapy","sponsor":"Shanghai Henlius Biotech","started":"2025-03-03","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06769113","kind":"trial","name":"A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy","aka":[],"tldr":"A phase 2 trial of HLX43 in oesophageal cancer, run by Shanghai Henlius Biotech, now recruiting.","summary":"A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy is a phase 2 interventional study registered as NCT06769113 by Shanghai Henlius Biotech, with 102 participants planned, started 2025-01-26 and due to reach its primary completion in 2026-10-31. Interventions recorded: HLX43.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06769113","url":"https://clinicaltrials.gov/study/NCT06769113"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal","oesophageal-squamous-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["hlx43"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06769113","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Recurrent/Metastatic Esophageal Squamous Cell Carcinoma (ESCC) Failed or Intolerance to Standard First-line Therapy","sponsor":"Shanghai Henlius Biotech","started":"2025-01-26","startedType":"actual","enrolled":102,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06907615","kind":"trial","name":"A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)","aka":[],"tldr":"A phase 2 trial of HLX43 DOSE 1 (2.0 mg/kg) in non-small-cell lung cancer, run by Shanghai Henlius Biotech, now recruiting.","summary":"A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) is a phase 2 interventional study registered as NCT06907615 by Shanghai Henlius Biotech, with 243 participants planned, started 2025-06-09 and due to reach its primary completion in 2028-04-20. Interventions recorded: HLX43 DOSE 1 (2.0 mg/kg) and HLX43 DOSE 2 (2.5 mg/kg).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06907615","url":"https://clinicaltrials.gov/study/NCT06907615"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06907615","phase":"2","setting":"An Open-label, Multi-center, Global Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)","sponsor":"Shanghai Henlius Biotech","started":"2025-06-09","startedType":"actual","enrolled":243,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07301229","kind":"trial","name":"A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Shanghai Henlius Biotech, not yet recruiting.","summary":"A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic Cancer is a phase 2, randomised interventional study registered as NCT07301229 by Shanghai Henlius Biotech, with a registry enrolment figure of 100 participants, started 2025-12-29 and due to reach its primary completion in 2028-02-21. Interventions recorded: HLX43 DOSE 1 (2.5 mg/kg); HLX43 DOSE 2 (3.0 mg/kg). Conditions listed: Pancreatic Ductal Adenocarcinoma (PDAC). Primary outcome: ORR; PFS. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed, unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC),who has failed at least one prior line of standard systemic therapy\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07301229","url":"https://clinicaltrials.gov/study/NCT07301229"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07301229","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Advanced Pancreatic Cancer","sponsor":"Shanghai Henlius Biotech","started":"2025-12-29","startedType":"estimated","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06769152","kind":"trial","name":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors","aka":[],"tldr":"A phase 2 trial of HLX43 in cervical cancer and ovarian cancer, run by Shanghai Henlius Biotech, now recruiting.","summary":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors is a phase 2 interventional study registered as NCT06769152 by Shanghai Henlius Biotech, with 190 participants planned, started 2025-02-20 and due to reach its primary completion in 2026-12-31. Interventions recorded: HLX43. Conditions listed: Cervical Cancer, Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06769152","url":"https://clinicaltrials.gov/study/NCT06769152"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["hlx43"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06769152","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Recurrent/Metastatic Gynecological Malignant Tumors Failed or Intolerance to Standard First-Line Therapy","sponsor":"Shanghai Henlius Biotech","started":"2025-02-20","startedType":"actual","enrolled":190,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07283198","kind":"trial","name":"A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd, not yet recruiting.","summary":"A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung Cancer is a phase 2, interventional study registered as NCT07283198 by Jiangsu Alphamab Biopharmaceuticals Co., Ltd, with a registry enrolment figure of 160 participants, started 2025-12-10 and due to reach its primary completion in 2027-08-30. Interventions recorded: JSKN033 Injection. Conditions listed: Non Small Cell Lung Cancer (NSCLC). Primary outcome: Number and Severity of Treatment-emergent Adverse Events (TEAEs); Objective response rate (ORR). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed locally advanced or metastatic NSCLC (per AJCC 8th Edition Lung Cancer TNM Staging) that is not eligible for curative surgery and/or curative radiotherapy\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07283198","url":"https://clinicaltrials.gov/study/NCT07283198"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["alphamab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07283198","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung Cancer","sponsor":"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","started":"2025-12-10","startedType":"estimated","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06746870","kind":"trial","name":"A Phase II Clinical Study to Evaluate the Safety, Pharmacokinetic Profile, and Preliminary Efficacy of IMM2510 in Combination with Chemotherapy As First-line Tr","aka":[],"tldr":"A phase 2 trial of cisplatin and carboplatin in triple-negative breast cancer, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc., not yet recruiting.","summary":"A Phase II Clinical Study to Evaluate the Safety, Pharmacokinetic Profile, and Preliminary Efficacy of IMM2510 in Combination with Chemotherapy As First-line Treatment in Subjects with Non-small Cell Lung Cancer or Triple-negative Breast Cancer is a phase 2, interventional study registered as NCT06746870 by ImmuneOnco Biopharmaceuticals (Shanghai) Inc., with a registry enrolment figure of 148 participants, started 2024-12 and due to reach its primary completion in 2025-11. Interventions recorded: IMM2510; Chemotherapy (pemetrexed + cisplatin/carboplatin); Chemotherapy (paclitaxel + cisplatin/carboplatin); Chemotherapy(Nab-paclitaxel). Conditions listed: NSCLC; TNBC. Triple-negative eligibility wording from the registry: \"If neoadjuvant and/or adjuvant treatment was previously received, the time from the completion of neoadjuvant and/or adjuvant treatment to the occurrence of recurrence/metastasis must be ≥ 12 months; Patients enrolled in the safety run-in period have previously failed at least first-line systemic tr\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06746870","url":"https://clinicaltrials.gov/study/NCT06746870"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06746870","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Safety, Pharmacokinetic Profile, and Preliminary Efficacy of IMM2510 in Combination with Chemotherapy As First-line Treatment in Subjects with Non-small Cell Lung Cancer or Triple-negative Breast Cancer","sponsor":"ImmuneOnco Biopharmaceuticals (Shanghai) Inc.","started":"2024-12","startedType":"estimated","enrolled":148,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04486378","kind":"trial","name":"A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of RO7198457 intravenous (IV) in colorectal cancer, run by BioNTech SE, active and no longer recruiting.","summary":"A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer is a phase 2 interventional study registered as NCT04486378 by BioNTech SE, with 327 participants enrolled, started 2021-03-08 and due to reach its primary completion in 2026-11. Interventions recorded: RO7198457 intravenous (IV).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04486378","url":"https://clinicaltrials.gov/study/NCT04486378"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["biontech","flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04486378","phase":"2","setting":"A Multi-site, Open-label, Phase II, Randomized, Controlled Trial to Compare the Efficacy of RO7198457 Versus Watchful Waiting in Resected, Stage II (High Risk) and Stage III Colorectal Cancer Patients Who Are ctDNA Positive Following Resection","sponsor":"BioNTech SE","started":"2021-03-08","startedType":"actual","enrolled":327,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06295432","kind":"trial","name":"A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21)","aka":["WU-KONG21"],"tldr":"A phase 2 trial of Sunvozertinib in non-small-cell lung cancer and small-cell lung cancer, run by Dizal Pharmaceuticals, now recruiting.","summary":"A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21) is a phase 2 interventional study registered as NCT06295432 by Dizal Pharmaceuticals, with 90 participants planned, started 2023-06-01 and due to reach its primary completion in 2026-12. Interventions recorded: DZD9008+AZD4205. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06295432","url":"https://clinicaltrials.gov/study/NCT06295432"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["sunvozertinib"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06295432","phase":"2","setting":"A Phase II, Multicenter Study to Assess the Safety, Tolerability and Anti-tumor Efficacy of DZD9008 in Combination With AZD4205 in Standard Treatment Failed Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Mutations","sponsor":"Dizal Pharmaceuticals","started":"2023-06-01","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07390383","kind":"trial","name":"A Phase II Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumour[Substudy 04]","aka":[],"tldr":"A phase 2 trial of Capecitabine, Tislelizumab and Oxaliplatin in advanced solid tumours, run by Nanjing Leads Biolabs Co.,Ltd, now recruiting.","summary":"A Phase II Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumour[Substudy 04] is a phase 2 interventional study registered as NCT07390383 by Nanjing Leads Biolabs Co.,Ltd, with 110 participants planned, started 2026-04-13 and due to reach its primary completion in 2028-05-30. Interventions recorded: LBL-024 for Injection, Capecitabine tablets, Tislelizumab Injection and Oxaliplatin injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07390383","url":"https://clinicaltrials.gov/study/NCT07390383"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["capecitabine","tislelizumab","oxaliplatin"],"companies":["nanjing-leads-biolabs"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07390383","phase":"2","setting":"An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour[Substudy Number 04]","sponsor":"Nanjing Leads Biolabs Co.,Ltd","started":"2026-04-13","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07489716","kind":"trial","name":"A Phase II Clinical Trial of SHR-1826 for Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of SHR-1826 in non-small-cell lung cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Phase II Clinical Trial of SHR-1826 for Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT07489716 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 90 participants planned, started 2026-04-29 and due to reach its primary completion in 2028-08. Interventions recorded: SHR-1826.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07489716","url":"https://clinicaltrials.gov/study/NCT07489716"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07489716","phase":"2","setting":"A Phase II Clinical Study on the Efficacy, Safety, and Pharmacokinetics of SHR-1826 for Injection in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2026-04-29","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07729033","kind":"trial","name":"A Phase II Exploratory Study of Sacituzumab Tirumotecan Combined With Envafolimab for TROP2-Positive Advanced Biliary Tract Cancers Previously Treated With First-Line Immunotherapy Combined With Chemotherapy.","aka":[],"tldr":"A phase 2 trial of sacituzumab tirumotecan and envafolimab in gallbladder cancer and other biliary tract cancers, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"A Phase II Exploratory Study of Sacituzumab Tirumotecan Combined With Envafolimab for TROP2-Positive Advanced Biliary Tract Cancers Previously Treated With First-Line Immunotherapy Combined With Chemotherapy. is a phase 2 interventional study registered as NCT07729033 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 28 participants, started 2026-08 and due to reach its primary completion in 2027-12. Interventions recorded: Sacituzumab tirumotecan combined with envafolimab. Conditions listed: Advanced Biliary Tract Cancers. Gallbladder cancer is named in the registry entry: \"* Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07729033","url":"https://clinicaltrials.gov/study/NCT07729033"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["sacituzumab-tirumotecan","envafolimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07729033","phase":"2","setting":"A Phase II Exploratory Study of Sacituzumab Tirumotecan Combined With Envafolimab for TROP2-Positive Advanced Biliary Tract Cancers Previously Treated With First-Line Immunotherapy Combined With Chemotherapy.","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2026-08","startedType":"estimated","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06906562","kind":"trial","name":"A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic","aka":[],"tldr":"A phase 2 trial of pemigatinib in pancreatic cancer, run by Sameek Roychowdhury, now recruiting.","summary":"A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations is a phase 2, interventional study registered as NCT06906562 by Sameek Roychowdhury, with a registry enrolment figure of 40 participants, started 2025-08-26 and due to reach its primary completion in 2026-12-31. Interventions recorded: Pemigatinib; Computed Tomography (CT); Magnetic Resonance Imaging; Optical Coherence Tomography; Bone Scan; Ophthalmoscopy. Conditions listed: Advanced Pancreatic Carcinoma; Metastatic Pancreatic Carcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8. Primary outcome: Overall Response Rate (ORR). Pancreatic eligibility wording from the registry: \"Patients with histologically or cytologically confirmed advanced or metastatic pancreatic cancer of any histologic classification at the time of diagnosis\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06906562","url":"https://clinicaltrials.gov/study/NCT06906562"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["pemigatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06906562","phase":"2","setting":"A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR2 Gene Fusions or Other FGFR Genetic Alterations","sponsor":"Sameek Roychowdhury","started":"2025-08-26","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07058012","kind":"trial","name":"A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal","aka":["EMPIRE"],"tldr":"A phase 2 trial of cemiplimab, fianlimab and REGN7075 in colorectal cancer, run by NSABP Foundation Inc, now recruiting.","summary":"A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE) is a phase 2, interventional study registered as NCT07058012 by NSABP Foundation Inc, with a registry enrolment figure of 79 participants, started 2026-04-17 and due to reach its primary completion in 2029-04-17. Interventions recorded: Cemiplimab; cemiplimab plus fianlimab; cemiplimab + REGN7075; ctDNA testing. Conditions listed: Colo-rectal Cancer. Primary outcome: Clearance of cDNA. Colorectal eligibility wording from the registry: \"* Patients must have confirmed histologic and pathologic stage II/III colon, stage II/III rectal, or oligometastatic stage IV colorectal adenocarcinoma (per AJCC 8th edition)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07058012","url":"https://clinicaltrials.gov/study/NCT07058012"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","mrd-testing"],"targets":[],"drugs":["cemiplimab","fianlimab","regn7075"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07058012","phase":"2","setting":"A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab and Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy","sponsor":"NSABP Foundation Inc","started":"2026-04-17","startedType":"actual","enrolled":79,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07402486","kind":"trial","name":"A Phase II Prospective Study of Maastro Applicator Brachytherapy for Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Siriraj Hospital, not yet recruiting.","summary":"A Phase II Prospective Study of Maastro Applicator Brachytherapy for Rectal Cancer is a phase 2, interventional study registered as NCT07402486 by Siriraj Hospital, with a registry enrolment figure of 20 participants, started 2026-03-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: Rectal HDR brachytherapy via Maastro Applicator. Conditions listed: Rectal Cancer. Primary outcome: Clinical Complete Response (cCR) Rate. Colorectal eligibility wording from the registry: \"Age ≥ 18 years at the time of informed consent Histologically confirmed rectal cancer Any T, N, or M stage, provided the primary rectal lesion is suitable for endorectal HDR brachytherapy Tumor characteristics deemed suitable for treatment with the Maastro applicator (per investigator assessment) Re\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07402486","url":"https://clinicaltrials.gov/study/NCT07402486"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07402486","phase":"2","setting":"A Phase II Prospective Clinical Study to Evaluate the Feasibility, Safety, and Early Efficacy of Maastro Applicator High-Dose-Rate Brachytherapy in Selected Patients With Rectal Cancer","sponsor":"Siriraj Hospital","started":"2026-03-01","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07604909","kind":"trial","name":"A Phase II Randomized Trial of Serplulimab With Second-Line Chemo/Targeted Therapy for Early Relapse Colorectal Cancer After Adjuvant Chemotherapy","aka":[],"tldr":"A phase 2 trial of serplulimab in colorectal cancer, run by Fudan University, now recruiting.","summary":"A Phase II Randomized Trial of Serplulimab With Second-Line Chemo/Targeted Therapy for Early Relapse Colorectal Cancer After Adjuvant Chemotherapy is a phase 2, randomised interventional study registered as NCT07604909 by Fudan University, with a registry enrolment figure of 40 participants, started 2026-05-10 and due to reach its primary completion in 2027-09-10. Interventions recorded: Serplulimab; Second-Line Chemo/Targeted Therapy. Conditions listed: Colorectal Cancer; Relapse. Primary outcome: Progression-free survival (PFS). Colorectal eligibility wording from the registry: \"Histologically confirmed early relapse (within 1 year after surgery, UICC stage IV) of colorectal cancer after adjuvant chemotherapy, with initially unresectable metastatic lesions or refusal of surgery\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07604909","url":"https://clinicaltrials.gov/study/NCT07604909"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07604909","phase":"2","setting":"A Phase II, Prospective, Randomized Study of Serplulimab Plus Second-Line Chemotherapy and Targeted Therapy vs Second-Line Chemotherapy and Targeted Therapy Alone in Patients With Early Relapse of Colorectal Cancer After Adjuvant Chemotherapy","sponsor":"Fudan University","started":"2026-05-10","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07248020","kind":"trial","name":"A Phase II Single-Arm Study of High-Bioavailability Curcumin as Neoadjuvant Chemoradiotherapy in Mid-to-Low Rectal Cancer: Integrated Clinical and Translational","aka":["BCMRECRAD"],"tldr":"A phase 2 trial in colorectal cancer, run by Chang Gung Memorial Hospital, not yet recruiting.","summary":"A Phase II Single-Arm Study of High-Bioavailability Curcumin as Neoadjuvant Chemoradiotherapy in Mid-to-Low Rectal Cancer: Integrated Clinical and Translational Analysis of Tumor Tissue is a phase 2, interventional study registered as NCT07248020 by Chang Gung Memorial Hospital, with a registry enrolment figure of 72 participants, started 2026-01-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: Curcumin (BCM-95®). Conditions listed: Rectal Cancer; Locally Advanced Rectal Cancer; Radiation-Induced Enteritis; Radiation Proctitis; Chemoradiotherapy-Related Toxicity. Primary outcome: Incidence of Grade ≥3 Gastrointestinal Toxicity (Enteritis or Proctitis) During Neoadjuvant Chemoradiotherapy. Colorectal eligibility wording from the registry: \"(A) Males and females more than 20 years of age (B) Signed informed consent (C) Patients with a pathologically proven rectal adenocarcinoma located less than 10 cm to the anus\". Sites: Taiwan. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07248020","url":"https://clinicaltrials.gov/study/NCT07248020"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07248020","phase":"2","setting":"A Phase II Single-Arm Study of High-Bioavailability Curcumin as Neoadjuvant Chemoradiotherapy in Mid-to-Low Rectal Cancer: Integrated Clinical and Translational Analysis of Tumor Tissue","sponsor":"Chang Gung Memorial Hospital","started":"2026-01-01","startedType":"estimated","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06015503","kind":"trial","name":"A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)","aka":["KANNON"],"tldr":"A phase 2 trial of PLB1004 in non-small-cell lung cancer, run by Avistone Biotechnology Co., Ltd., active and no longer recruiting.","summary":"A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC) is a phase 2 interventional study registered as NCT06015503 by Avistone Biotechnology Co., Ltd., with 139 participants enrolled, started 2023-07-21 and due to reach its primary completion in 2025-03-06. Interventions recorded: PLB1004.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06015503","url":"https://clinicaltrials.gov/study/NCT06015503"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["avistone-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct06015503-j-thorac-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06015503","phase":"2","setting":"A Phase Ⅱ,Open-label, Single-line, Multiple Cohorts, Multicenter Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)","sponsor":"Avistone Biotechnology Co., Ltd.","started":"2023-07-21","startedType":"actual","enrolled":139,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07283705","kind":"trial","name":"A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of navlimetostat, gemcitabine, nab-paclitaxel and fOLFIRINOX / mFOLFIRINOX in pancreatic cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer is a phase 2, interventional study registered as NCT07283705 by M.D. Anderson Cancer Center, with a registry enrolment figure of 60 participants, started 2026-04-09 and due to reach its primary completion in 2029-10-01. Interventions recorded: BMS-986504; Gemcitabine; Nab-paclitaxel; mFOLFIRINOX. Conditions listed: Phase 2 Study; BMS-986504; MTAP-deleted Pancreatic Cancer. Primary outcome: Safety and adverse events (AEs). Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07283705","url":"https://clinicaltrials.gov/study/NCT07283705"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["navlimetostat","gemcitabine","nab-paclitaxel","folfirinox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07283705","phase":"2","setting":"A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer","sponsor":"M.D. Anderson Cancer Center","started":"2026-04-09","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06008288","kind":"trial","name":"A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.","aka":[],"tldr":"A phase 2 trial of Glecirasib in pancreatic ductal adenocarcinoma, run by Allist Pharmaceuticals, Inc., now recruiting.","summary":"A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation. is a phase 2 interventional study registered as NCT06008288 by Allist Pharmaceuticals, Inc., with 88 participants planned, started 2023-10-27 and due to reach its primary completion in 2026-12-31. Interventions recorded: JAB-21822.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06008288","url":"https://clinicaltrials.gov/study/NCT06008288"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","kras-g12c-pdac","metastatic-pdac"],"sections":[],"technologies":["kinase-inhibitors","kras-inhibitors"],"targets":[],"drugs":["glecirasib"],"companies":["allist"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06008288","phase":"2","setting":"A Single-arm, Multicenter, Open-label Phase II Clinical Study Evaluating the Efficacy and Safety of JAB-21822 Monotherapy in Patients With Locally Advanced or Metastatic Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.","sponsor":"Allist Pharmaceuticals, Inc.","started":"2023-10-27","startedType":"actual","enrolled":88,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07405801","kind":"trial","name":"A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer","aka":[],"tldr":"A phase 2 trial of Inavolisib, Ribociclib and Fulvestrant in advanced solid tumours, run by Hoffmann-La Roche, now recruiting.","summary":"A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer is a phase 2 interventional study registered as NCT07405801 by Hoffmann-La Roche, with 80 participants planned, started 2026-04-07 and due to reach its primary completion in 2028-12-19. Interventions recorded: Inavolisib, Ribociclib, Fulvestrant and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07405801","url":"https://clinicaltrials.gov/study/NCT07405801"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy","kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["inavolisib","ribociclib","fulvestrant"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07405801","phase":"2","setting":"A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation","sponsor":"Hoffmann-La Roche","started":"2026-04-07","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05849298","kind":"trial","name":"A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC","aka":["PSMACare"],"tldr":"A phase 2 trial of AAA617 in prostate cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC is a phase 2 interventional study registered as NCT05849298 by Novartis Pharmaceuticals, with 49 participants enrolled, started 2024-01-03 and due to reach its primary completion in 2026-12-23. Interventions recorded: AAA617, AAA517, Piflufolastat F 18, ARPI and ADT.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05849298","url":"https://clinicaltrials.gov/study/NCT05849298"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["advanced-accelerator-applications"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05849298","phase":"2","setting":"An International Prospective Open-label, Multi-center, Randomized, Non-comparative Phase II Study of Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) Alone and Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) in Combination With Androgen Receptor Pathway Inhibitors in Patients With PSMA PET Scan Positive Castration-Resistant Prostate Cancer","sponsor":"Novartis Pharmaceuticals","started":"2024-01-03","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07679399","kind":"trial","name":"A Phase II Study of Adjuvant Durvalumab Combined With GEMOX/GC Chemotherapy Followed by Lenvatinib Versus Capecitabine in Biliary Tract Cancer.","aka":[],"tldr":"A phase 2 trial of durvalumab, capecitabine, gemcitabine and other drugs in gallbladder cancer and other biliary tract cancers, run by Peking Union Medical College Hospital, now recruiting.","summary":"A Phase II Study of Adjuvant Durvalumab Combined With GEMOX/GC Chemotherapy Followed by Lenvatinib Versus Capecitabine in Biliary Tract Cancer. is a phase 2, randomised interventional study registered as NCT07679399 by Peking Union Medical College Hospital, with a registry enrolment figure of 222 participants, started 2025-06-01 and due to reach its primary completion in 2027-01-01. Interventions recorded: Durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib, Capecitabine. Conditions listed: Biliary Tract Neoplasms Immunotherapy. Gallbladder cancer is named in the registry entry: \"3. Histologically confirmed cholangiocarcinoma or gallbladder cancer (excluding pancreatic cancer or ampullary cancer)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07679399","url":"https://clinicaltrials.gov/study/NCT07679399"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","kinase-inhibitors"],"targets":[],"drugs":["durvalumab","capecitabine","gemcitabine","oxaliplatin","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07679399","phase":"2","setting":"A Randomized, Open-label, Phase II Clinical Study of Durvalumab Combined With GEMOX/GC Chemotherapy Followed by Lenvatinib Versus Capecitabine as Adjuvant Therapy for Biliary Tract Cancer.","sponsor":"Peking Union Medical College Hospital","started":"2025-06-01","startedType":"actual","enrolled":222,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07591090","kind":"trial","name":"A Phase II Study of AK146D1 Combined With AK112 in Advanced Breast Cancer","aka":[],"tldr":"A phase 2 trial of AK146D1 in advanced solid tumours, run by Akeso, now recruiting.","summary":"A Phase II Study of AK146D1 Combined With AK112 in Advanced Breast Cancer is a phase 2 interventional study registered as NCT07591090 by Akeso, with 200 participants planned, started 2026-07-17 and due to reach its primary completion in 2027-09-01. Interventions recorded: AK146D1 for injection and AK112 Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07591090","url":"https://clinicaltrials.gov/study/NCT07591090"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["bispecific-adc"],"targets":[],"drugs":["ak146d1"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07591090","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of AK146D1 Combined With AK112 in Patients With Advanced Breast Cancer","sponsor":"Akeso","started":"2026-07-17","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07669779","kind":"trial","name":"A Phase II Study of AK146D1 in Combination With AK112 in Advanced Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of AK146D1, Ivonescimab, Osimertinib in non-small-cell lung cancer and small-cell lung cancer, run by Akeso, now recruiting.","summary":"A Phase II Study of AK146D1 in Combination With AK112 in Advanced Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT07669779 by Akeso, with 348 participants planned, started 2026-07-10 and due to reach its primary completion in 2027-08-30. Interventions recorded: AK146D1 for injection, AK112 Injection, Platinum chemotherapy, Osimertinib. Conditions listed: Advanced Non Small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07669779","url":"https://clinicaltrials.gov/study/NCT07669779"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["bispecific-adc"],"targets":[],"drugs":["ak146d1","ivonescimab","osimertinib"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07669779","phase":"2","setting":"A Phase II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antitumor Efficacy of AK146D1 in Combination With AK112 or Other Anticancer Therapies in Patients With Advanced Non-Small Cell Lung Cancer","sponsor":"Akeso","started":"2026-07-10","startedType":"actual","enrolled":348,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07474727","kind":"trial","name":"A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of FLOT, Bevacizumab, Cetuximab in colorectal cancer, run by Multitude Therapeutics Inc., now recruiting.","summary":"A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer is a phase 2 interventional study registered as NCT07474727 by Multitude Therapeutics Inc., with 180 participants planned, started 2026-04-29 and due to reach its primary completion in 2027-09-30. Interventions recorded: AMT-676, 5-FU, Leucovorin, Bevacizumab, Cetuximab. Conditions listed: Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07474727","url":"https://clinicaltrials.gov/study/NCT07474727"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["flot","bevacizumab","cetuximab","folfiri","capox"],"companies":["multitude-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07474727","phase":"2","setting":"An Phase II Study Evaluating the Safety and Efficacy of AMT-676 in Combination With 5-fluorouracil, Leucovorin, Bevacizumab (or Cetuximab) in Participants of Advanced Colorectal Cancer","sponsor":"Multitude Therapeutics Inc.","started":"2026-04-29","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07743190","kind":"trial","name":"A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early-Stage Triple Negative Breast Cancer (TNBC) P","aka":["NeoTILs"],"tldr":"A phase 2 trial of carboplatin and pembrolizumab in triple-negative breast cancer, run by Medical University of South Carolina, now recruiting.","summary":"A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early-Stage Triple Negative Breast Cancer (TNBC) Patients With High Tumor-Infiltrating Lymphocytes (TILs) is a phase 2, interventional study registered as NCT07743190 by Medical University of South Carolina, with a registry enrolment figure of 55 participants, started 2026-10-01 and due to reach its primary completion in 2029-03-01. Interventions recorded: Carboplatin; Paclitaxcel; Pembrolizumab. Conditions listed: Triple Negative Breast Cancer (TNBC); Elevated Tumor-Infiltrating Lymphocytes. Triple-negative eligibility wording from the registry: \"Histologically confirmed diagnosis of triple-negative breast cancer (TNBC) or hormone receptor-low invasive breast carcinoma, with clinical anatomic Stage II or Stage IIIA/B as defined by the AJCC 8th Edition Anatomic Breast Cancer Staging System\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07743190","url":"https://clinicaltrials.gov/study/NCT07743190"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07743190","phase":"2","setting":"NeoTILs: A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early-Stage Triple Negative Breast Cancer (TNBC) Patients With High Tumor-Infiltrating Lymphocytes (TILs)","sponsor":"Medical University of South Carolina","started":"2026-10-01","startedType":"estimated","enrolled":55,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01503502","kind":"trial","name":"A Phase II Study of Flumatinib Versus Imatinib to Treat Philadelphia Chromosome Positive Chronic Myelogenous Leukemia","aka":[],"tldr":"A phase 2 trial of Flumatinib and Imatinib in Leukaemia, run by Jiangsu HengRui Medicine Co., Ltd., with a status the registry has not verified recently.","summary":"A Phase II Study of Flumatinib Versus Imatinib to Treat Philadelphia Chromosome Positive Chronic Myelogenous Leukemia is a phase 2 interventional study registered as NCT01503502 by Jiangsu HengRui Medicine Co., Ltd., with 150 participants planned, started 2011-08 and due to reach its primary completion in 2012-06. Interventions recorded: flumatinib, imatinib. Conditions recorded: Myelogenous Leukemia, Chronic.\n\nLinked to the drug Flumatinib because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01503502","url":"https://clinicaltrials.gov/study/NCT01503502"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["flumatinib","imatinib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01503502","phase":"2","setting":"Phase II Study of Flumatinib Versus Imatinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2011-08","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07560111","kind":"trial","name":"A Phase II Study of GC101 in NSCLC","aka":[],"tldr":"A phase 2 trial of GC101 TIL in non-small-cell lung cancer and small-cell lung cancer, run by Shanghai Juncell Therapeutics, now recruiting.","summary":"A Phase II Study of GC101 in NSCLC is a phase 2 interventional study registered as NCT07560111 by Shanghai Juncell Therapeutics, with 28 participants planned, started 2026-06-01 and due to reach its primary completion in 2027-06-01. Interventions recorded: Autologous Tumor Infiltrating Lymphocytes. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07560111","url":"https://clinicaltrials.gov/study/NCT07560111"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["gc101-til"],"companies":["shanghai-juncell-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07560111","phase":"2","setting":"An Open-Label, Phase II Study to Evaluate the Safety and Efficacy Using Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Non-Small Cell Lung Cancer","sponsor":"Shanghai Juncell Therapeutics","started":"2026-06-01","startedType":"actual","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07784374","kind":"trial","name":"A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metast","aka":[],"tldr":"A phase 2 trial of GFH375 in pancreatic cancer, run by Genfleet Therapeutics (Shanghai) Inc., not yet recruiting.","summary":"A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation is a phase 2, randomised interventional study registered as NCT07784374 by Genfleet Therapeutics (Shanghai) Inc., with a registry enrolment figure of 120 participants, started 2026-08-31 and due to reach its primary completion in 2028-08-31. Interventions recorded: GFH375; GFH276; GFS202A. Conditions listed: Pancreatic Cancer. Primary outcome: PFS; Weight. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed pancreatic adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07784374","url":"https://clinicaltrials.gov/study/NCT07784374"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["gfh375"],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07784374","phase":"2","setting":"A Phase II, Multicenter, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of GFH375 in Combination With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation","sponsor":"Genfleet Therapeutics (Shanghai) Inc.","started":"2026-08-31","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07623642","kind":"trial","name":"A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.","aka":[],"tldr":"A phase 2 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by GV20 Therapeutics, not yet recruiting.","summary":"A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors. is a phase 2 interventional study registered as NCT07623642 by GV20 Therapeutics, with a registry enrolment figure of 227 participants, started 2026-06-02 and due to reach its primary completion in 2028-06-15. Interventions recorded: GV20-0251, anti-PD-1 monoclonal antibodies. Conditions listed: Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms, Prostatic Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, Cholangiocarcinoma, Gallbladder Neoplasms, Colorectal Neoplasms, Pancreatic Ductal Adenocarcinoma, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma. Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07623642","url":"https://clinicaltrials.gov/study/NCT07623642"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["gv20-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07623642","phase":"2","setting":"An Open-Label, Multicenter, Non-Randomized, Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors","sponsor":"GV20 Therapeutics","started":"2026-06-02","startedType":"estimated","enrolled":227,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06832202","kind":"trial","name":"A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients","aka":[],"tldr":"A phase 2 trial of HLX22 and Trastuzumab deruxtecan in HER2-positive breast cancer, run by Shanghai Henlius Biotech, now recruiting.","summary":"A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients is a phase 2 interventional study registered as NCT06832202 by Shanghai Henlius Biotech, with 50 participants planned, started 2025-04-16 and due to reach its primary completion in 2027-06-01. Interventions recorded: HLX22 and Trastuzumab Deruxtecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06832202","url":"https://clinicaltrials.gov/study/NCT06832202"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["hlx22","trastuzumab-deruxtecan"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06832202","phase":"2","setting":"A Phase II Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients With Intolerable Adverse Reaction or Disease Progression on Standard of Care","sponsor":"Shanghai Henlius Biotech","started":"2025-04-16","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07438106","kind":"trial","name":"A Phase II Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by The First Affiliated Hospital with Nanjing Medical University, now recruiting.","summary":"A Phase II Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT07438106 by The First Affiliated Hospital with Nanjing Medical University, with a registry enrolment figure of 30 participants, started 2026-01-28 and due to reach its primary completion in 2027-10. Interventions recorded: HRS-4642 Injection. Conditions listed: Locally Advanced Pancreatic Cancer With KRAS G12D Mutation. Primary outcome: To evaluate the efficacy of HRS-4642 combined with AG (nab-paclitaxel and gemcitabine) as conversion therapy in patients with locally advanced pancreatic cancer, as measured by the Objective Response Rate (ORR).. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed pancreatic ductal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07438106","url":"https://clinicaltrials.gov/study/NCT07438106"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07438106","phase":"2","setting":"A Phase II Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer","sponsor":"The First Affiliated Hospital with Nanjing Medical University","started":"2026-01-28","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07824882","kind":"trial","name":"A Phase II Study of HS-20093 Injection Combined With Adebrelimab Versus HS-20093 Injection in Previously Treated Patients With Advanced or Metastatic Non-Squamo","aka":[],"tldr":"A phase 2 trial of adebrelimab in lung cancer, run by Hansoh BioMedical R&D Company, not yet recruiting.","summary":"A Phase II Study of HS-20093 Injection Combined With Adebrelimab Versus HS-20093 Injection in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations is a phase 2, randomised interventional study registered as NCT07824882 by Hansoh BioMedical R&D Company, with a registry enrolment figure of 76 participants, started 2026-09-10 and due to reach its primary completion in 2028-03-30. Interventions recorded: HS-20093 for Injection; Adebrelimab Injection. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Objective Response Rate (ORR); Progression-Free Survival (PFS). Lung eligibility wording from the registry: \"Previously treated patients with histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07824882","url":"https://clinicaltrials.gov/study/NCT07824882"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07824882","phase":"2","setting":"A Multicenter, Randomized, Open-Label, Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HS-20093 Injection Combined With Adebrelimab Versus HS-20093 Injection in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations","sponsor":"Hansoh BioMedical R&D Company","started":"2026-09-10","startedType":"estimated","enrolled":76,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06728410","kind":"trial","name":"A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement","aka":[],"tldr":"A phase 2 trial of durvalumab and pemigatinib in gallbladder cancer and other biliary tract cancers, run by Mehmet Akce, now recruiting.","summary":"A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement is a phase 2 interventional study registered as NCT06728410 by Mehmet Akce, with a registry enrolment figure of 38 participants, started 2026-01-27 and due to reach its primary completion in 2027-07. Interventions recorded: Pemigatinib, Durvalumab. Conditions listed: Intrahepatic Cholangiocarcinoma, FGFR2 Gene Rearrangement, FGFR2 Gene Mutation. Gallbladder cancer is named in the registry entry: \"5. Histologically diagnosed locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma with FGFR-2 fusion or rearrangement detected by Clinical Laboratory Improvement Act (CLIA)-certified assays includin\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06728410","url":"https://clinicaltrials.gov/study/NCT06728410"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","ampullary"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["durvalumab","pemigatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06728410","phase":"2","setting":"A Phase II Study of Pemigatinib Plus Durvalumab (MEDI4736) in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement","sponsor":"Mehmet Akce","started":"2026-01-27","startedType":"actual","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07644286","kind":"trial","name":"A Phase II Study of Pirfenidone Plus PD-1 Inhibitor With or Without Hypofractionated Radiotherapy for Refractory pMMR/MSS Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Tao Zhang, now recruiting.","summary":"A Phase II Study of Pirfenidone Plus PD-1 Inhibitor With or Without Hypofractionated Radiotherapy for Refractory pMMR/MSS Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07644286 by Tao Zhang, with a registry enrolment figure of 48 participants, started 2025-12-01 and due to reach its primary completion in 2027-01-25. Interventions recorded: Pirfenidone in combination with a PD-1 inhibitor; hypofractionated radiotherapy. Conditions listed: Colorectal Cancer (CRC). Primary outcome: Progression Free Survival（PFS）. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed, unresectable locally advanced or metastatic pMMR/MSS colorectal cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07644286","url":"https://clinicaltrials.gov/study/NCT07644286"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07644286","phase":"2","setting":"Phase II Study Evaluating the Safety, Tolerability, and Efficacy of Pirfenidone and PD-1 Inhibitor With or Without Hypofractionated Radiotherapy in Patients With Advanced, Refractory pMMR/MSS Colorectal Cancer","sponsor":"Tao Zhang","started":"2025-12-01","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06962865","kind":"trial","name":"A Phase Ⅱ Study of RC108 in Combination With Furmonertinib for the First-line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Adv","aka":[],"tldr":"A phase 2 trial of Furmonertinib in non-small-cell lung cancer and small-cell lung cancer, run by RemeGen Co., Ltd., now recruiting.","summary":"A Phase Ⅱ Study of RC108 in Combination With Furmonertinib for the First-line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC is a phase 2 interventional study registered as NCT06962865 by RemeGen Co., Ltd., with 80 participants planned, started 2025-06-30 and due to reach its primary completion in 2026-05-31. Interventions recorded: RC108, Furmonertinib Mesilate Tablets Monotherapy. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06962865","url":"https://clinicaltrials.gov/study/NCT06962865"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["furmonertinib"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06962865","phase":"2","setting":"A Randomized, Open, Controlled, Multicenter Phase II Clinical Study of RC108 in Combination With Furmonertinib Versus Furmonertinib for the First-Line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC","sponsor":"RemeGen Co., Ltd.","started":"2025-06-30","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07071714","kind":"trial","name":"A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of SHR-8068, Adebrelimab, Bevacizumab in colorectal cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., active and no longer recruiting.","summary":"A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer is a phase 2 interventional study registered as NCT07071714 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 103 participants enrolled, started 2025-07-22 and due to reach its primary completion in 2031-10. Interventions recorded: SHR-8068 Injection, Adebrelimab Injection, Bevacizumab Injection. Conditions listed: Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07071714","url":"https://clinicaltrials.gov/study/NCT07071714"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-8068","adebrelimab","bevacizumab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07071714","phase":"2","setting":"An Open, Multicenter Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-07-22","startedType":"actual","enrolled":103,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07506109","kind":"trial","name":"A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colo","aka":[],"tldr":"A phase 2 trial of sintilimab, cetuximab and dabrafenib in colorectal cancer, run by Tianjin Medical University Cancer Institute and Hospital, now recruiting.","summary":"A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT07506109 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 49 participants, started 2026-03-01 and due to reach its primary completion in 2027-12. Interventions recorded: Ipilimumab N01; Sintilimab; Cetuximab; Dabrafenib. Conditions listed: BRAF V600E; Colorectal Cancer; Sintilimab; MSS (Microsatellite Stable); Cetuximab; Dabrafenib; Ipilimumab N01. Primary outcome: Progression-Free Survival (PFS). Colorectal eligibility wording from the registry: \"Histologically or pathologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07506109","url":"https://clinicaltrials.gov/study/NCT07506109"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","braf-v600e-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["sintilimab","cetuximab","dabrafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07506109","phase":"2","setting":"A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2026-03-01","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07230405","kind":"trial","name":"A Phase II Study of SKB571 in Patients With Lung Cancer","aka":[],"tldr":"A phase 2 trial of SKB571 for injection in advanced solid tumours, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"A Phase II Study of SKB571 in Patients With Lung Cancer is a phase 2 interventional study registered as NCT07230405 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 295 participants planned, started 2026-01-19 and due to reach its primary completion in 2028-01-19. Interventions recorded: SKB571 for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07230405","url":"https://clinicaltrials.gov/study/NCT07230405"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07230405","phase":"2","setting":"A Phase II Study to Evaluate the Safety and Efficacy of SKB571 in Patients With Advanced Non-small Cell Lung Cancer","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-01-19","startedType":"actual","enrolled":295,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07171606","kind":"trial","name":"A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients","aka":[],"tldr":"A phase 2 trial of SSGJ-706, Carboplatin and Pemetrexed in non-small-cell lung cancer, run by Shenyang Sunshine Pharmaceutical Co., LTD., now recruiting.","summary":"A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients is a phase 2 interventional study registered as NCT07171606 by Shenyang Sunshine Pharmaceutical Co., LTD., with 240 participants planned, started 2025-10-24 and due to reach its primary completion in 2026-08-31. Interventions recorded: SSGJ-706, pemetrexed /carboplatin, Carboplatin/Paclitaxel and PD-1 Inhibitor + Chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07171606","url":"https://clinicaltrials.gov/study/NCT07171606"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ssgj-706","carboplatin","pemetrexed"],"companies":["3sbio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07171606","phase":"2","setting":"A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients","sponsor":"Shenyang Sunshine Pharmaceutical Co., LTD.","started":"2025-10-24","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06329947","kind":"trial","name":"A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Rui-hua Xu, MD, PhD, not yet recruiting.","summary":"A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD is a phase 2, interventional study registered as NCT06329947 by Rui-hua Xu, MD, PhD, with a registry enrolment figure of 37 participants, started 2024-05-22 and due to reach its primary completion in 2025-01-01. Interventions recorded: Surufatinib 250mg/d qd once daily. Conditions listed: Advanced Pancreatic Cancer. Primary outcome: objective response rate (ORR). Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed metastatic pancreatic cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06329947","url":"https://clinicaltrials.gov/study/NCT06329947"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06329947","phase":"2","setting":"A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD","sponsor":"Rui-hua Xu, MD, PhD","started":"2024-05-22","startedType":"estimated","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05231850","kind":"trial","name":"A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With Stage II and Stage III Colon Cancer and dMMR/MSI.","aka":[],"tldr":"A phase 2 trial of tislelizumab in colorectal cancer, run by The First Affiliated Hospital of Zhengzhou University, not yet recruiting.","summary":"A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With Stage II and Stage III Colon Cancer and dMMR/MSI. is a phase 2, interventional study registered as NCT05231850 by The First Affiliated Hospital of Zhengzhou University, with a registry enrolment figure of 70 participants, started 2022-03-01 and due to reach its primary completion in 2023-09-01. Interventions recorded: Tislelizumab. Conditions listed: Colon Cancer. Primary outcome: Primary End point: Disease Free survival [ Time Frame: 3 years ]. Colorectal eligibility wording from the registry: \", any T, N1 or N2, M0) adenocarcinoma of the colon (as defined by the presence of the inferior pole of the tumour above the peritoneal reflection - that is, at least 15 cm from the anal margin)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05231850","url":"https://clinicaltrials.gov/study/NCT05231850"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05231850","phase":"2","setting":"A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With High-risk Stage II and Stage III Colon Cancer and Deficient Mismatch Repair or Microsatellite Instability.","sponsor":"The First Affiliated Hospital of Zhengzhou University","started":"2022-03-01","startedType":"estimated","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07815223","kind":"trial","name":"A Phase II Study of Tislelizumab Plus Anlotinib Consolidation After Chemoradiotherapy in LS-SCLC","aka":[],"tldr":"A phase 2 trial of tislelizumab and anlotinib in lung cancer, run by Yantai Yuhuangding Hospital, now recruiting.","summary":"A Phase II Study of Tislelizumab Plus Anlotinib Consolidation After Chemoradiotherapy in LS-SCLC is a phase 2, interventional study registered as NCT07815223 by Yantai Yuhuangding Hospital, with a registry enrolment figure of 20 participants, started 2025-11-04 and due to reach its primary completion in 2028-12-31. Interventions recorded: Tislelizumab + Anlotinib. Conditions listed: SCLC, Limited Stage. Primary outcome: Progression Free Survival (PFS); Overall Survival (OS). Lung eligibility wording from the registry: \"Have histologically or cytologically confirmed small-cell lung cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07815223","url":"https://clinicaltrials.gov/study/NCT07815223"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["limited-stage-sclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","imrt-igrt","kinase-inhibitors"],"targets":[],"drugs":["tislelizumab","anlotinib"],"companies":["beone","sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07815223","phase":"2","setting":"A Prospective, Single-Arm, Phase II Study of Tislelizumab Plus Anlotinib as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Progression After Concurrent or Sequential Chemoradiotherapy","sponsor":"Yantai Yuhuangding Hospital","started":"2025-11-04","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02050321","kind":"trial","name":"A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma","aka":[],"tldr":"A phase 2 trial of Acitretin and Vemurafenib in Melanoma, run by University of Arizona, recorded as terminated on the registry.","summary":"A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma is a phase 2 interventional study registered as NCT02050321 by University of Arizona, with 2 participants recorded, started 2013-12 and due to reach its primary completion in 2014-12. Interventions recorded: Acitretin, Vemurafenib. Conditions recorded: Malignant Melanoma.\n\nLinked to the drug Acitretin because the registry names it among its interventions and Melanoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02050321","url":"https://clinicaltrials.gov/study/NCT02050321"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["acitretin","vemurafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02050321","phase":"2","setting":"A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma","sponsor":"University of Arizona","started":"2013-12","enrolled":2,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06839066","kind":"trial","name":"A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy","aka":[],"tldr":"A phase 2 trial of HLX43 DOSE 1 in nasopharyngeal carcinoma, run by Shanghai Henlius Biotech, now recruiting.","summary":"A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy is a phase 2 interventional study registered as NCT06839066 by Shanghai Henlius Biotech, with 70 participants planned, started 2025-04-02 and due to reach its primary completion in 2026-11-22. Interventions recorded: HLX43 DOSE 1, HLX43 DOSE 2 and HLX43 DOSE 3.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06839066","url":"https://clinicaltrials.gov/study/NCT06839066"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nasopharyngeal","recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06839066","phase":"2","setting":"A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma (NPC) Failed or Intolerance to Second-line Therapy","sponsor":"Shanghai Henlius Biotech","started":"2025-04-02","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07269782","kind":"trial","name":"A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC","aka":[],"tldr":"A phase 2 trial of Serplulimab in non-small-cell lung cancer and small-cell lung cancer, run by Shanghai Henlius Biotech, now recruiting.","summary":"A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC is a phase 2 interventional study registered as NCT07269782 by Shanghai Henlius Biotech, with 60 participants planned, started 2026-01-20 and due to reach its primary completion in 2026-07-10. Interventions recorded: HLX43 DOSE 1, HLX43 DOSE 2, Serplulimab. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07269782","url":"https://clinicaltrials.gov/study/NCT07269782"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["serplulimab"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07269782","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC","sponsor":"Shanghai Henlius Biotech","started":"2026-01-20","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06241846","kind":"trial","name":"A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC","aka":[],"tldr":"A phase 2 trial of YL201 in prostate cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd., now recruiting.","summary":"A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC is a phase 2 interventional study registered as NCT06241846 by MediLink Therapeutics (Suzhou) Co., Ltd., with 100 participants planned, started 2024-02-22 and due to reach its primary completion in 2027-02. Interventions recorded: YL201 for Injection. Conditions listed: Metastatic Castration-resistant Prostate Cancer (mCRPC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06241846","url":"https://clinicaltrials.gov/study/NCT06241846"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["yl201"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06241846","phase":"2","setting":"A Multicenter, Open-Label, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With Metastatic Castration-Resistant Prostate Cancer","sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","started":"2024-02-22","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00006371","kind":"trial","name":"A Phase II Trial of Early Medical Adrenalectomy for \"D0.5\" Prostate Cancer","aka":[],"tldr":"A phase 2 trial of Aminoglutethimide in Prostate cancer, run by H. Lee Moffitt Cancer Center and Research Institute, recorded as terminated on the registry.","summary":"A Phase II Trial of Early Medical Adrenalectomy for \"D0.5\" Prostate Cancer is a phase 2 interventional study registered as NCT00006371 by H. Lee Moffitt Cancer Center and Research Institute, with 2 participants recorded, started 2000-05 and due to reach its primary completion in 2001-12. Interventions recorded: aminoglutethimide, ketoconazole, therapeutic hydrocortisone. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Aminoglutethimide because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00006371","url":"https://clinicaltrials.gov/study/NCT00006371"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["aminoglutethimide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00006371","phase":"2","setting":"A Phase II Trial of Early Medical Adrenalectomy for \"D0.5\" Prostate Cancer","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","started":"2000-05","enrolled":2,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07444437","kind":"trial","name":"A Phase II Trial of LM103 for Adjuvant Treatment in Patients With Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of LM103 TILs Injection in non-small-cell lung cancer, run by Suzhou BlueHorse Therapeutics Co., Ltd., now recruiting.","summary":"A Phase II Trial of LM103 for Adjuvant Treatment in Patients With Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT07444437 by Suzhou BlueHorse Therapeutics Co., Ltd., with 45 participants planned, started 2026-02-26 and due to reach its primary completion in 2027-12-31. Interventions recorded: LM103 TILs Injection and PD-1 / PD-L1 monoclonal antibody.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07444437","url":"https://clinicaltrials.gov/study/NCT07444437"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":["pd1","pdl1"],"drugs":[],"companies":["suzhou-bluehorse-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07444437","phase":"2","setting":"A Multicenter, Randomized, Controlled, Open-label, Phase IIa Trial on Autologous Tumor Infiltrating Lymphocyte Injection (LM103 TILs) for the Adjuvant Treatment of Non-small Cell Lung Cancer With Negative Driver Gene Mutations","sponsor":"Suzhou BlueHorse Therapeutics Co., Ltd.","started":"2026-02-26","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07310784","kind":"trial","name":"A Phase II Trial of LM103 in Advanced Melanoma","aka":[],"tldr":"A phase 2 trial of Dacarbazine, Temozolomide, Paclitaxel / nab-paclitaxel in melanoma, run by Suzhou BlueHorse Therapeutics Co., Ltd., now recruiting.","summary":"A Phase II Trial of LM103 in Advanced Melanoma is a phase 2 interventional study registered as NCT07310784 by Suzhou BlueHorse Therapeutics Co., Ltd., with 92 participants planned, started 2025-12-16 and due to reach its primary completion in 2027-12-31. Interventions recorded: LM103 TILs Injection, Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin. Conditions listed: Advanced Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07310784","url":"https://clinicaltrials.gov/study/NCT07310784"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["dacarbazine","temozolomide","paclitaxel","carboplatin","cisplatin"],"companies":["suzhou-bluehorse-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07310784","phase":"2","setting":"A Multicenter, Randomized, Controlled, Open-label, Phase II Trial on Autologous Tumor Infiltrating Lymphocyte Injection (LM103 TILs) for the Treatment of Advanced Melanoma","sponsor":"Suzhou BlueHorse Therapeutics Co., Ltd.","started":"2025-12-16","startedType":"actual","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07351591","kind":"trial","name":"A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Biliary Tract Cancers","aka":[],"tldr":"A phase 2 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by Eastern Hepatobiliary Surgery Hospital, not yet recruiting.","summary":"A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Biliary Tract Cancers is a phase 2 interventional study registered as NCT07351591 by Eastern Hepatobiliary Surgery Hospital, with a registry enrolment figure of 88 participants, started 2026-01-30 and due to reach its primary completion in 2026-10-30. Interventions recorded: Organoid Drug Sensitivity Testing-Guided Therapy. Conditions listed: Advanced Biliary Tract Cancer(BTC). No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07351591","url":"https://clinicaltrials.gov/study/NCT07351591"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07351591","phase":"2","setting":"Patient-Derived Tumor Organoid Drug Sensitivity Testing to Guide Treatment Selection in Patients With Unresectable Biliary Tract Cancers: A Prospective, Non-randomized, Open-label, Single-Center Phase II Clinical Trial","sponsor":"Eastern Hepatobiliary Surgery Hospital","started":"2026-01-30","startedType":"estimated","enrolled":88,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07051486","kind":"trial","name":"A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer","aka":[],"tldr":"A phase 2 trial of Trastuzumab rezetecan in cervical cancer, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer is a phase 2 interventional study registered as NCT07051486 by Jiangsu HengRui Medicine Co., Ltd., with 60 participants planned, started 2025-10-11 and due to reach its primary completion in 2026-02. Interventions recorded: SHR-A1811 Injection. Conditions listed: Recurrent or Metastatic Cervical Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07051486","url":"https://clinicaltrials.gov/study/NCT07051486"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07051486","phase":"2","setting":"A Single-Arm, Multicenter Phase II Clinical Trial of SHR-A1811 for Injection in Patients With HER2-Expressing Recurrent or Metastatic Cervical Cancer Progressing After Standard Treatment","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-10-11","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03301805","kind":"trial","name":"A Phase II, EvaluateBLEX 404 Combined With Gemcitabine Monotherapy With Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Rgene Corporation, not yet recruiting.","summary":"A Phase II, EvaluateBLEX 404 Combined With Gemcitabine Monotherapy With Pancreatic Cancer is a phase 2, interventional study registered as NCT03301805 by Rgene Corporation, with a registry enrolment figure of 40 participants, started 2026-07-01 and due to reach its primary completion in 2027-04-30. Interventions recorded: BLEX 404. Conditions listed: Pancreatic Cancer. Primary outcome: Part I: Dose-limiting toxicity (DLT) observation; Part II: Overall response rate (PR + CR). Pancreatic eligibility wording from the registry: \"Patients with pathologically proved adenocarcinoma of pancreatic cancer and diagnosed with inoperable/metastatic disease (previous systemic chemotherapy, neoadjuvant or adjuvant gemcitabine are acceptable, unless exclusion criteria met)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03301805","url":"https://clinicaltrials.gov/study/NCT03301805"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac","locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03301805","phase":"2","setting":"A Phase II, Open Label Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Gemcitabine Monotherapy in Patients With Advanced Inoperable or Metastatic Pancreatic Cancer","sponsor":"Rgene Corporation","started":"2026-07-01","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07441512","kind":"trial","name":"A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of inavolisib and eribulin in triple-negative breast cancer, run by Hu Hai, not yet recruiting.","summary":"A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation is a phase 2, interventional study registered as NCT07441512 by Hu Hai, with a registry enrolment figure of 26 participants, started 2026-03-15 and due to reach its primary completion in 2028-03-15. Interventions recorded: Inavolisib in Combination With Eribulin. Conditions listed: TNBC - Triple-Negative Breast Cancer; TNBC. Triple-negative eligibility wording from the registry: \"* Prior treatment with PARP inhibitors for advanced TNBC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07441512","url":"https://clinicaltrials.gov/study/NCT07441512"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["inavolisib","eribulin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07441512","phase":"2","setting":"A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation","sponsor":"Hu Hai","started":"2026-03-15","startedType":"estimated","enrolled":26,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07318883","kind":"trial","name":"A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab","aka":[],"tldr":"A phase 2/3 trial of serplulimab, pembrolizumab and carboplatin in lung cancer, run by Shanghai Henlius Biotech, not yet recruiting.","summary":"A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer is a phase 2/3, randomised interventional study registered as NCT07318883 by Shanghai Henlius Biotech, with a registry enrolment figure of 720 participants, started 2026-03 and due to reach its primary completion in 2031-01. Interventions recorded: HLX07; HLX07 placebo; Serplulimab; Pembrolizumab; Carboplatin; Paclitaxel or Nab-Paclitaxel. Conditions listed: Squamous NSCLC. Primary outcome: ORR assessed by BICR (part I); PFS assessed by BICR (part I); PFS assessed by BICR (part II). Lung eligibility wording from the registry: \"Histologically confirmed with stage IIIB/IIIC or IV (AJCC 8th edition) squamous NSCLC ineligible for surgery or radical radiotherapy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07318883","url":"https://clinicaltrials.gov/study/NCT07318883"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["serplulimab","pembrolizumab","carboplatin"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07318883","phase":"2/3","setting":"A Randomized, Double-Blind, Multicenter, Phase II/III Clinical Study to Evaluate HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Patients With Advanced Squamous Non-Small Cell Lung Cancer (sqNSCLC)","sponsor":"Shanghai Henlius Biotech","started":"2026-03","startedType":"estimated","enrolled":720,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07462143","kind":"trial","name":"A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2/3 trial of RC148, CAPOX in colorectal cancer, run by RemeGen Co., Ltd., now recruiting.","summary":"A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer is a phase 2/3 interventional study registered as NCT07462143 by RemeGen Co., Ltd., with 80 participants planned, started 2026-05-12 and due to reach its primary completion in 2027-05-12. Interventions recorded: RC148 (Dose 1) plus Capecitabine and Oxaliplatin, RC148 (Dose 2) plus Capecitabine and Oxaliplatin. Conditions listed: Colorectal (Colon or Rectal) Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07462143","url":"https://clinicaltrials.gov/study/NCT07462143"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["rc148","capox"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07462143","phase":"2/3","setting":"A Randomized, Multicenter, Phase Ⅱ/Ⅲ Study of RC148 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy as First-line Treatment for Unresectable or Metastatic Colorectal Cancer","sponsor":"RemeGen Co., Ltd.","started":"2026-05-12","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06335355","kind":"trial","name":"A Phase II/III Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or Metastatic NSCLC Patients","aka":[],"tldr":"A phase 2/3 trial of adebrelimab, SHR-8068, pemetrexed, carboplatin and other drugs in lung cancer, run by Shanghai Shengdi Pharmaceutical Co., Ltd, not yet recruiting.","summary":"A Phase II/III Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or Metastatic NSCLC Patients is a phase 2/3, randomised interventional study registered as NCT06335355 by Shanghai Shengdi Pharmaceutical Co., Ltd, with a registry enrolment figure of 401 participants, started 2024-03 and due to reach its primary completion in 2028-10. Interventions recorded: Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin; Camrelizumab + Pemetrexed + Carboplatin; Adebrelimab + Pemetrexed + Carboplatin. Conditions listed: Non-squamous Non-small Cell Lung Cancer. Primary outcome: Investigator-assessed Objective Response Rate (Phase One); Overall Survival (Phase Two). Lung eligibility wording from the registry: \"Diagnosed with advanced or metastatic non-squamous NSCLC (non-small cell lung cancer) confirmed by histology or cytology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06335355","url":"https://clinicaltrials.gov/study/NCT06335355"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["adebrelimab","shr-8068","pemetrexed","carboplatin","camrelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06335355","phase":"2/3","setting":"A Phase II/III, Randomized, Open-label, Parallel-controlled, Multicenter Study of Adebrelimab (SHR-1316) in Combination With SHR-8068 and Platinum-based Doublet Chemotherapy as First-line Treatment in Advanced or Metastatic NSCLC Patients With STK11/KEAP1/KRAS Mutations","sponsor":"Shanghai Shengdi Pharmaceutical Co., Ltd","started":"2024-03","startedType":"estimated","enrolled":401,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07761429","kind":"trial","name":"A Phase II/III Study of F520 Combined With Paclitaxel Plus Carboplatin in the Treatment of Cancer of Unknown Primary (CUP)","aka":[],"tldr":"A phase 2/3 trial of F520 combined with chemotherapy in cancer of unknown primary, run by Shandong New Time Pharmaceutical Co., LTD, now recruiting.","summary":"A Phase II/III Study of F520 Combined With Paclitaxel Plus Carboplatin in the Treatment of Cancer of Unknown Primary (CUP) is a phase 2/3 interventional study registered as NCT07761429 by Shandong New Time Pharmaceutical Co., LTD, with 402 participants planned, started 2026-07-08 and due to reach its primary completion in 2027-12-30. Interventions recorded: F520 combined with chemotherapy and placebo combined with chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07761429","url":"https://clinicaltrials.gov/study/NCT07761429"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cancer-of-unknown-primary","cup-unfavourable"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shandong-new-time-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07761429","phase":"2/3","setting":"A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Study Evaluating the Safety and Efficacy of F520 Combined With Paclitaxel Plus Carboplatin as First-line Treatment for Cancer of Unknown Primary","sponsor":"Shandong New Time Pharmaceutical Co., LTD","started":"2026-07-08","startedType":"actual","enrolled":402,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05945901","kind":"trial","name":"A Phase II/III Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2/3 trial testing HR070803 in colorectal cancer, active and no longer recruiting.","summary":"A Phase II/III Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer is a phase 2/3 interventional study registered as NCT05945901, led by Jiangsu HengRui Medicine, and active but no longer recruiting on the registry. Official title: A Phase II/III, Double-blind, Randomised, Multi-centre Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer. Planned enrolment is 669 participants (actual). The study started in 2023-08-14 and primary completion is expected in 2025-12-01. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05945901","url":"https://clinicaltrials.gov/study/NCT05945901"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["hr070803"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05945901","phase":"2/3","setting":"A Phase II/III, Double-blind, Randomized, Multi-center Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer","sponsor":"Jiangsu HengRui Medicine","started":"2023-08-14","startedType":"actual","enrolled":669,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07076095","kind":"trial","name":"A Phase II/III Study of IBB0979 in Combination With Topotecan Versus Topotecan in Relapsed Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial in lung cancer, run by SUNHO（China）BioPharmaceutical CO., Ltd., not yet recruiting.","summary":"A Phase II/III Study of IBB0979 in Combination With Topotecan Versus Topotecan in Relapsed Small Cell Lung Cancer is a phase 2, interventional study registered as NCT07076095 by SUNHO（China）BioPharmaceutical CO., Ltd., with a registry enrolment figure of 200 participants, started 2025-08-01 and due to reach its primary completion in 2028-08-01. Interventions recorded: IBB0979; topotecan hydrochloride for injection. Conditions listed: Small Cell Lung Cancer. Primary outcome: Frequency of adverse events (AEs) and SAEs (Phase II). Lung eligibility wording from the registry: \"Histologically confirmed SCLC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07076095","url":"https://clinicaltrials.gov/study/NCT07076095"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sunho-biopharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07076095","phase":"2","setting":"A Phase II/III Study to Compare IBB0979 in Combination With Topotecan Versus Topotecan in Subjects With Relapsed Small Cell Lung Cancer","sponsor":"SUNHO（China）BioPharmaceutical CO., Ltd.","started":"2025-08-01","startedType":"estimated","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06844357","kind":"trial","name":"A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer.","aka":[],"tldr":"A phase 2/3 trial of tirapazamine in hepatocellular carcinoma, run by Zhejiang Raygene Pharmaceuticals Co., Ltd, now recruiting.","summary":"A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer. is a phase 2/3 interventional study registered as NCT06844357 by Zhejiang Raygene Pharmaceuticals Co., Ltd, with 300 participants planned, started 2025-03-27 and due to reach its primary completion in 2029-04-01. Interventions recorded: tirapazamine, Transarterial Embolization (TAE) and TACE.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06844357","url":"https://clinicaltrials.gov/study/NCT06844357"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-intermediate"],"sections":[],"technologies":["tace"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06844357","phase":"2/3","setting":"A Multi-center, Randomized, Controlled, Open-label Phase II/III Clinical Trial to Investigate Whether Transarterial Tirapazamine Injection Followed by Transarterial Embolization (TATE) is Superior to Traditional Transarterial Chemoembolization (TACE) in Patients With Intermediate-Stage Hepatocellular Carcinoma (HCC)","sponsor":"Zhejiang Raygene Pharmaceuticals Co., Ltd","started":"2025-03-27","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06361888","kind":"trial","name":"A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2/3 trial of Gemcitabine and Camrelizumab in pancreatic ductal adenocarcinoma, run by Hutchmed, now recruiting.","summary":"A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer is a phase 2/3 interventional study registered as NCT06361888 by Hutchmed, with 502 participants planned, started 2024-05-08 and due to reach its primary completion in 2028-05-31. Interventions recorded: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine and Surufatinib with Nab-paclitaxel, and Gemcitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06361888","url":"https://clinicaltrials.gov/study/NCT06361888"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","camrelizumab","surufatinib"],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06361888","phase":"2/3","setting":"A Multicenter, Randomized, Open-label, Active-controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine Versus Nab-paclitaxel Plus Gemcitabine as the First-line Treatment in Metastatic Pancreatic Cancer","sponsor":"Hutchmed","started":"2024-05-08","startedType":"actual","enrolled":502,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06485219","kind":"trial","name":"A Phase IIa Clinical Study of Purinostat Mesylate for Injection in Patients With Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma","aka":[],"tldr":"A phase 2 trial of Purinostat in peripheral T-cell lymphomas, run by Chengdu Zenitar Biomedical Technology Co., Ltd, active and no longer recruiting.","summary":"A Phase IIa Clinical Study of Purinostat Mesylate for Injection in Patients With Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma is a phase 2 interventional study registered as NCT06485219 by Chengdu Zenitar Biomedical Technology Co., Ltd, with 50 participants enrolled, started 2024-04-14 and due to reach its primary completion in 2026-06-30. Interventions recorded: 11.2 mg/m2 Purinostat Mesylate and 15 mg/m2 Purinostat Mesylate.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06485219","url":"https://clinicaltrials.gov/study/NCT06485219"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma","cutaneous-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["purinostat"],"companies":["chengdu-zenitar-biomedical-technology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06485219","phase":"2","setting":"An Open-Label, Multicenter Phase IIa Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Purinostat Mesylate for Injection for the Treatment of Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma","sponsor":"Chengdu Zenitar Biomedical Technology Co., Ltd","started":"2024-04-14","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05411718","kind":"trial","name":"A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome","aka":[],"tldr":"A phase 2 trial of aspirin in colorectal cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome is a phase 2, randomised interventional study registered as NCT05411718 by M.D. Anderson Cancer Center, with a registry enrolment figure of 40 participants, started 2023-03-21 and due to reach its primary completion in 2026-11-30. Interventions recorded: Naproxen; Aspirin. Conditions listed: T Cells; Colorectal Cancer; Lynch Syndrome. Primary outcome: To establish the effect of naproxen or aspirin on the abundance of T cells and other immune. Colorectal eligibility wording from the registry: \"* Participants must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05411718","url":"https://clinicaltrials.gov/study/NCT05411718"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["aspirin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05411718","phase":"2","setting":"A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome","sponsor":"M.D. Anderson Cancer Center","started":"2023-03-21","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06810804","kind":"trial","name":"A Phase IIa Study to Evaluate NBQ72S","aka":[],"tldr":"A phase 2 trial of NBQ72S in advanced solid tumours, run by Nantong Bencao Quadriga Medical Technology Co. Ltd., now recruiting.","summary":"A Phase IIa Study to Evaluate NBQ72S is a phase 2 interventional study registered as NCT06810804 by Nantong Bencao Quadriga Medical Technology Co. Ltd., with 10 participants planned, started 2025-04-22 and due to reach its primary completion in 2026-08-31. Interventions recorded: NBQ72S.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06810804","url":"https://clinicaltrials.gov/study/NCT06810804"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06810804","phase":"2","setting":"A Phase IIa Study to Evaluate the Efficacy and Safety of NBQ72S in Breast Cancer Patients With Leptomeningeal Metastases, With or Without Brain Parenchymal Metastases","sponsor":"Nantong Bencao Quadriga Medical Technology Co. Ltd.","started":"2025-04-22","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07521852","kind":"trial","name":"A Phase IIa, Single-arm, Open-label Clinical Study to Evaluate the Efficacy, Safety and PK of CVM-1118 in Combination With Sintilimab and TACE in Part","aka":[],"tldr":"A phase 2 trial of Sintilimab in hepatocellular carcinoma, run by TaiRx, Inc., now recruiting.","summary":"A Phase IIa, Single-arm, Open-label Clinical Study to Evaluate the Efficacy, Safety and PK of CVM-1118 in Combination With Sintilimab and TACE in Participants With Incurable/Non-metastatic HCC is a phase 2 interventional study registered as NCT07521852 by TaiRx, Inc., with 40 participants planned, started 2026-03-31 and due to reach its primary completion in 2027-12-31. Interventions recorded: CVM-1118 + Sintilimab + TACE. Conditions listed: HCC - Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07521852","url":"https://clinicaltrials.gov/study/NCT07521852"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-intermediate"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["sintilimab"],"companies":["tairx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07521852","phase":"2","setting":"A Phase IIa, Single-arm, Open-label Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic (PK) of CVM-1118 in Combination With Sintilimab and Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma","sponsor":"TaiRx, Inc.","started":"2026-03-31","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07269158","kind":"trial","name":"A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in Patients With Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 1/2 trial of durvalumab, pembrolizumab and lenvatinib in gallbladder cancer and other biliary tract cancers, run by Yonsei University, not yet recruiting.","summary":"A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in Patients With Advanced Biliary Tract Cancer is a phase 1/2, randomised interventional study registered as NCT07269158 by Yonsei University, with a registry enrolment figure of 160 participants, started 2025-12 and due to reach its primary completion in 2029-09. Interventions recorded: Durvalumab or Pembrolizumab, Durvalumab or Pembrolizumab + Levnatinib, Durvalumab or Pembrolizumab + Venadaparib, Durvalumab or Pembrolizumab + SCL-3010. Conditions listed: Biliary Tract Neoplasms, Advanced Cancer, Immunotherapy. Gallbladder cancer is named in the registry entry: \"* Patients with histologically confirmed biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma.\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07269158","url":"https://clinicaltrials.gov/study/NCT07269158"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["durvalumab","pembrolizumab","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07269158","phase":"1/2","setting":"A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in Patients With Advanced Biliary Tract Cancer","sponsor":"Yonsei University","started":"2025-12","startedType":"estimated","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07168200","kind":"trial","name":"A Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the","aka":[],"tldr":"A phase 3 trial of Adebrelimab, Cisplatin, Carboplatin in cervical cancer, run by Shanghai Shengdi Pharmaceutical Co., Ltd, now recruiting.","summary":"A Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer is a phase 3 interventional study registered as NCT07168200 by Shanghai Shengdi Pharmaceutical Co., Ltd, with 720 participants planned, started 2025-10-17 and due to reach its primary completion in 2028-04. Interventions recorded: SHR-1316 Injection, Cisplatin Injection, Carboplatin Injection, Paclitaxel Injection, SHR-1316 Placebo Injection. Conditions listed: Advanced Cervical Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07168200","url":"https://clinicaltrials.gov/study/NCT07168200"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","locally-advanced-cervical-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["adebrelimab","cisplatin","carboplatin","paclitaxel"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07168200","phase":"3","setting":"A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer","sponsor":"Shanghai Shengdi Pharmaceutical Co., Ltd","started":"2025-10-17","startedType":"actual","enrolled":720,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07023315","kind":"trial","name":"A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma","aka":[],"tldr":"A phase 3 trial of Cadonilimab in gastric & gastro-oesophageal junction cancer, run by Akeso, now recruiting.","summary":"A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma is a phase 3 interventional study registered as NCT07023315 by Akeso, with 760 participants planned, started 2025-08-14 and due to reach its primary completion in 2029-07. Interventions recorded: Cadonilimab, SOX chemotherapy and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07023315","url":"https://clinicaltrials.gov/study/NCT07023315"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["cadonilimab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07023315","phase":"3","setting":"A Randomized, Double-blind, Phase III Clinical Study Comparing the Efficacy and Safety of Cadonilimab Plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) Versus Placebo Plus SOX as Perioperative Treatment for Patients With Resectable Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma","sponsor":"Akeso","started":"2025-08-14","startedType":"actual","enrolled":760,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04914598","kind":"trial","name":"A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions","aka":[],"tldr":"A phase 3 trial of Cisplatin in advanced solid tumours, run by Jiangsu Simcere Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions is a phase 3 interventional study registered as NCT04914598 by Jiangsu Simcere Pharmaceutical Co., Ltd., with 290 participants enrolled, started 2021-07-28 and due to reach its primary completion in 2025-02-10. Interventions recorded: ENDOSTAR，cisplatin and Placebo , cisplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04914598","url":"https://clinicaltrials.gov/study/NCT04914598"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin"],"companies":["simcere"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04914598","phase":"3","setting":"A Randomized, Controlled, Double-blind, Multi-center Phase Ⅲ Registration Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions","sponsor":"Jiangsu Simcere Pharmaceutical Co., Ltd.","started":"2021-07-28","startedType":"actual","enrolled":290,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06532006","kind":"trial","name":"A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer","aka":[],"tldr":"A phase 3 trial testing HLX22 in gastric & gastro-oesophageal junction cancer, now recruiting.","summary":"A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer is a phase 3 interventional study registered as NCT06532006, led by Shanghai Henlius Biotech with Henlius USA, and recruiting on the registry. Official title: A Randomised, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer. Planned enrolment is 550 participants (estimated). The study started in 2024-11-22 and primary completion is expected in 2027-06-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06532006","url":"https://clinicaltrials.gov/study/NCT06532006"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["hlx22"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06532006","phase":"3","setting":"A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer","sponsor":"Shanghai Henlius Biotech","started":"2024-11-22","startedType":"actual","enrolled":550,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07011056","kind":"trial","name":"A Phase III Clinical Study of Purinostat Mesylate for Injection in Patients With Diffuse Large B-cell Lymphoma","aka":[],"tldr":"A phase 3 trial testing Purinostat in diffuse large B-cell lymphoma, now recruiting.","summary":"A Phase III Clinical Study of Purinostat Mesylate for Injection in Patients With Diffuse Large B-cell Lymphoma is a phase 3 interventional study registered as NCT07011056, led by Chengdu Zenitar Biomedical Technology, and recruiting on the registry. Official title: A Randomised, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of the Purinostat Mesylate for Injection (PM) Compared to Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL). Planned enrolment is 390 participants (estimated). The study started in 2025-07-18 and primary completion is expected in 2029-06-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07011056","url":"https://clinicaltrials.gov/study/NCT07011056"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["purinostat"],"companies":["chengdu-zenitar-biomedical-technology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07011056","phase":"3","setting":"A Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of the Purinostat Mesylate for Injection (PM) Compared to Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)","sponsor":"Chengdu Zenitar Biomedical Technology","started":"2025-07-18","startedType":"actual","enrolled":390,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07241416","kind":"trial","name":"A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Rezvilutamide run by Jiangsu HengRui Medicine Co., Ltd. in prostate cancer, now recruiting.","summary":"A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer is a phase 3 interventional study registered as NCT07241416 by Jiangsu HengRui Medicine Co., Ltd., with 206 participants planned, started 2025-12-05. Conditions listed: Metastatic Hormone-sensitive Prostate Cancer (mHSPC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07241416","url":"https://clinicaltrials.gov/study/NCT07241416"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["rezvilutamide"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07241416","phase":"3","setting":"A Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Study of Rezvilutamide Combined With Androgen Deprivation Therapy (ADT) Versus Enzalutamide Combined With ADT for Treating Low-volume Metastatic Hormone Sensitive Prostate Cancer (mHSPC)","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-12-05","startedType":"actual","enrolled":206,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07376382","kind":"trial","name":"A Phase III Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC","aka":["SYNSTAR-02"],"tldr":"A phase 3 trial of SYS6010 and osimertinib in lung cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd., not yet recruiting.","summary":"A Phase III Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC is a phase 3, randomised interventional study registered as NCT07376382 by CSPC Megalith Biopharmaceutical Co.,Ltd., with a registry enrolment figure of 680 participants, started 2026-06-01 and due to reach its primary completion in 2026-12-12. Interventions recorded: SYS6010; Osimertinib; platinum-pemetrexed. Conditions listed: NSCLC. Primary outcome: Progression Free Survival(PFS) evaluated by IRC. Lung eligibility wording from the registry: \"Patients with pathologically confirmed locally advanced or metastatic NSCLC, including: patients with stage IIIB or IIIC based on AJCC staging version 8 who are not suitable for surgical resection or radical chemoradiotherapy, or patients with stage IV NSCLC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07376382","url":"https://clinicaltrials.gov/study/NCT07376382"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["sys6010","osimertinib"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07376382","phase":"3","setting":"A Randomized, Open-label, Multicenter, Phase III Clinical Trial to Evaluate the Safety and Efficacy of SYS6010 in Combination With Osimertinib in Patients With EGFR-mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","started":"2026-06-01","startedType":"estimated","enrolled":680,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05262010","kind":"trial","name":"A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years","aka":[],"tldr":"A phase 3 trial of 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) in advanced solid tumours, run by National Vaccine and Serum Institute, China, now recruiting.","summary":"A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years is a phase 3 interventional study registered as NCT05262010 by National Vaccine and Serum Institute, China, with 13500 participants planned, started 2022-06-04 and due to reach its primary completion in 2028-06. Interventions recorded: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) and placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05262010","url":"https://clinicaltrials.gov/study/NCT05262010"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05262010","phase":"3","setting":"A Multicenter Randomized, Blinded, Placebo-controlled Phase III Clinical Trial Evaluating the Protective Efficacy, Safety and Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years","sponsor":"National Vaccine and Serum Institute, China","started":"2022-06-04","startedType":"actual","enrolled":13500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01827605","kind":"trial","name":"A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL)","aka":[],"tldr":"A phase 3 trial of Ibritumomab tiuxetan in Follicular lymphoma, run by Fondazione Italiana Linfomi - ETS, completed.","summary":"A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL) is a phase 3 interventional study registered as NCT01827605 by Fondazione Italiana Linfomi - ETS, with 159 participants recorded, started 2012-01 and reaching its primary completion in 2019-10. Interventions recorded: ZEVALIN, BEAM. Conditions recorded: Relapsed Follicular Lymphoma.\n\nLinked to the drug Ibritumomab tiuxetan because the registry names it among its interventions and Follicular lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01827605","url":"https://clinicaltrials.gov/study/NCT01827605"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["ibritumomab-tiuxetan"],"companies":["fondazione-italiana-linfomi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01827605","phase":"3","setting":"A Phase III Multicenter,Randomized Study Comparing Consolidation With 90yttrium-Labeled Ibritumomab Tiuxetan (Zevalin®) Radioimmunotherapy Vs Autologous Stem Cell Transplantation (ASCT) in Patients With Relapsed/Refractory Follicular Lymphoma (FL) Aged 18-65 Years","sponsor":"Fondazione Italiana Linfomi - ETS","started":"2012-01","enrolled":159,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06112379","kind":"trial","name":"A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer","aka":["TROPION-Breast04"],"tldr":"A phase 3 trial of Durvalumab, Pembrolizumab, Doxorubicin, Epirubicin, Cyclophosphamide and Carboplatin in HR-positive / HER2-negative breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer is a phase 3 interventional study registered as NCT06112379 by AstraZeneca, with 1902 participants enrolled, started 2023-11-14 and due to reach its primary completion in 2028-11-20. Interventions recorded: Dato-DXd, Durvalumab, Pembrolizumab, Doxorubicin, Epirubicin and Cyclophosphamide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06112379","url":"https://clinicaltrials.gov/study/NCT06112379"},{"label":"TROPION-Breast04 design","url":"https://doi.org/10.1177/17588359251316176"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","tnbc","tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","pembrolizumab","doxorubicin","epirubicin","cyclophosphamide","carboplatin"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["TROPION-Breast04 (design, Therapeutic Advances in Medical Oncology 2025): neoadjuvant datopotamab deruxtecan with durvalumab then adjuvant durvalumab with or without chemotherapy, against the KEYNOTE-522 regimen, in untreated triple-negative or hormone-receptor-low HER2-negative breast cancer; 1,902 patients randomised (registry actual), primary endpoint event-free survival, primary completion November 2028. UK sites (registry, 7): Birmingham, Cardiff, Lancaster, London, Northampton, Oxford, Taunton."],"nct":"NCT06112379","phase":"3","setting":"A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)","sponsor":"AstraZeneca","started":"2023-11-14","startedType":"actual","enrolled":1902,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07103668","kind":"trial","name":"A Phase III Randomized Study in CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer Patients","aka":[],"tldr":"A phase 3 trial of CAR T cells in gastric & gastro-oesophageal junction cancer, run by Suzhou Immunofoco Biotechnology Co., Ltd, now recruiting.","summary":"A Phase III Randomized Study in CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer Patients is a phase 3 interventional study registered as NCT07103668 by Suzhou Immunofoco Biotechnology Co., Ltd, with 150 participants planned, started 2025-08-06 and due to reach its primary completion in 2027-05-31. Interventions recorded: CAR T cells and Control.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07103668","url":"https://clinicaltrials.gov/study/NCT07103668"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","gastric-cldn18-2-positive"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07103668","phase":"3","setting":"An Open-label, Randomized, Comparative Phase III Study Including Patients With CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer.","sponsor":"Suzhou Immunofoco Biotechnology Co., Ltd","started":"2025-08-06","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07311694","kind":"trial","name":"A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer","aka":[],"tldr":"A phase 3 trial testing HRS-4357 in prostate cancer, now recruiting.","summary":"A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer is a phase 3 interventional study registered as NCT07311694, led by Jiangsu HengRui Medicine, and recruiting on the registry. Official title: A Phase III, Randomised, Open-Label, Multicenter Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer. Planned enrolment is 370 participants (estimated). The study started in 2026-02-02 and primary completion is expected in 2027-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07311694","url":"https://clinicaltrials.gov/study/NCT07311694"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["hrs-4357"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07311694","phase":"3","setting":"A Phase III, Randomized, Open-Label, Multicenter Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer","sponsor":"Jiangsu HengRui Medicine","started":"2026-02-02","startedType":"actual","enrolled":370,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06564324","kind":"trial","name":"A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients","aka":["TRUST-III"],"tldr":"A phase 3 trial of Taletrectinib, Crizotinib in non-small-cell lung cancer and small-cell lung cancer, run by Nuvation Bio Inc., now recruiting.","summary":"A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients is a phase 3 interventional study registered as NCT06564324 by Nuvation Bio Inc., with 194 participants planned, started 2024-11-27 and due to reach its primary completion in 2029-01. Interventions recorded: Taletrectinib, Crizotinib. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06564324","url":"https://clinicaltrials.gov/study/NCT06564324"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","ros1-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["taletrectinib","crizotinib"],"companies":["nuvation-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06564324","phase":"3","setting":"A Phase 3 Multicenter Open-label Study of Taletrectinib Versus a Standard of Care ROS1-Tyrosine Kinase Inhibitor (Crizotinib) in TKI-Naïve Patients With ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRUST-III)","sponsor":"Nuvation Bio Inc.","started":"2024-11-27","startedType":"actual","enrolled":194,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05489289","kind":"trial","name":"A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection","aka":[],"tldr":"A phase 3 trial of Cadonilimab in hepatocellular carcinoma, run by Akeso, now recruiting.","summary":"A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection is a phase 3 interventional study registered as NCT05489289 by Akeso, with 570 participants planned, started 2023-01-05 and due to reach its primary completion in 2026-01-28. Interventions recorded: AK104, placebo. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05489289","url":"https://clinicaltrials.gov/study/NCT05489289"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-early"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["cadonilimab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05489289","phase":"3","setting":"A Randomized, Double-blind, Phase III Clinical Study on the Efficacy and Safety of AK104 Versus Placebo as Adjuvant Therapy for Hepatocellular Carcinoma With High Risk of Recurrence After Curative Resection","sponsor":"Akeso","started":"2023-01-05","startedType":"actual","enrolled":570,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05450692","kind":"trial","name":"A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy","aka":["LATIFY"],"tldr":"A phase 3 trial testing Ceralasertib in non-small-cell lung cancer, active and no longer recruiting.","summary":"A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy is a phase 3 interventional study registered as NCT05450692, led by AstraZeneca with Parexel, and active but no longer recruiting on the registry. Official title: A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFY. Planned enrolment is 594 participants (actual). The study started in 2022-09-15 and primary completion is expected in 2025-10-06. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05450692","url":"https://clinicaltrials.gov/study/NCT05450692"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ceralasertib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05450692","phase":"3","setting":"A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFY","sponsor":"AstraZeneca","started":"2022-09-15","startedType":"actual","enrolled":594,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06464991","kind":"trial","name":"A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)","aka":["FUMANBA-03"],"tldr":"A phase 3 trial of Equecabtagene autoleucel, Daratumumab, Pomalidomide in multiple myeloma, run by Nanjing IASO Biotechnology Co., Ltd., now recruiting.","summary":"A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03) is a phase 3 interventional study registered as NCT06464991 by Nanjing IASO Biotechnology Co., Ltd., with 240 participants planned, started 2024-03-27 and due to reach its primary completion in 2027-08. Interventions recorded: Equecabtagene Autoleucel Injection, Daratumumab, Pomalidomide, Bortezomib, Dexamethasone. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06464991","url":"https://clinicaltrials.gov/study/NCT06464991"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["equecabtagene-autoleucel","daratumumab","pomalidomide","bortezomib","dexamethasone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06464991","phase":"3","setting":"A Phase III Randomized, Controlled Study of Equecabtagene Autoleucel Injection in Subjects With Lenalidomide-Refractory R/R Multiple Myeloma","sponsor":"Nanjing IASO Biotechnology Co., Ltd.","started":"2024-03-27","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06383767","kind":"trial","name":"A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer","aka":[],"tldr":"A phase 3 trial testing ESG401 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer is a phase 3 interventional study registered as NCT06383767, led by Qilu Pharmaceutical, and recruiting on the registry. Official title: A Open-label, Randomised, Multicenter Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy. Planned enrolment is 378 participants (estimated). The study started in 2024-07-11 and primary completion is expected in 2027-06-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06383767","url":"https://clinicaltrials.gov/study/NCT06383767"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["esg401"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06383767","phase":"3","setting":"A Open-label, Randomized, Multicenter Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy","sponsor":"Qilu Pharmaceutical","started":"2024-07-11","startedType":"actual","enrolled":378,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06732323","kind":"trial","name":"A Phase III Study of ESG401 for Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 3 trial testing ESG401 in triple-negative breast cancer, now recruiting.","summary":"A Phase III Study of ESG401 for Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer is a phase 3 interventional study registered as NCT06732323, led by Qilu Pharmaceutical, and recruiting on the registry. Official title: A Randomised, Open-label, Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy as First-line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer. Planned enrolment is 504 participants (estimated). The study started in 2025-09-04 and primary completion is expected in 2027-06. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06732323","url":"https://clinicaltrials.gov/study/NCT06732323"}],"tags":["ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["esg401"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06732323","phase":"3","setting":"A Randomized, Open-label, Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy as First-line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer","sponsor":"Qilu Pharmaceutical","started":"2025-09-04","startedType":"actual","enrolled":504,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06313983","kind":"trial","name":"A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer","aka":[],"tldr":"A phase 3 trial of Capecitabine and Lapatinib in advanced solid tumours, run by Tianjin Hemay Pharmaceutical Co., Ltd, now recruiting.","summary":"A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer is a phase 3 interventional study registered as NCT06313983 by Tianjin Hemay Pharmaceutical Co., Ltd, with 339 participants planned, started 2022-01-08 and due to reach its primary completion in 2025-12. Interventions recorded: Hemay022+AI and Lapatinib+Capecitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06313983","url":"https://clinicaltrials.gov/study/NCT06313983"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["capecitabine","lapatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06313983","phase":"3","setting":"A Phase Ⅲ Randomized, Open Label, Parallel, Multicenter To Assess Efficacy and Safety Study of Hemay022 in Combination With AI In Postmenopausal HER2+/ER+ Advanced Breast Cancer Patients Treated With Trastuzumab-containing Regimens","sponsor":"Tianjin Hemay Pharmaceutical Co., Ltd","started":"2022-01-08","startedType":"actual","enrolled":339,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07409428","kind":"trial","name":"A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL","aka":[],"tldr":"A phase 3 trial testing HMPL-760 in diffuse large B-cell lymphoma, now recruiting.","summary":"A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL is a phase 3 interventional study registered as NCT07409428, led by Hutchmed, and recruiting on the registry. Official title: A Phase III Randomised, Double-Blind, Positive Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 in Combination With R-GemOx Versus Placebo in Combination With R-GemOx in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL). Planned enrolment is 240 participants (estimated). The study started in 2026-03-20 and primary completion is expected in 2028-04-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07409428","url":"https://clinicaltrials.gov/study/NCT07409428"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["hmpl-760"],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07409428","phase":"3","setting":"A Phase III Randomized, Double-Blind, Positive Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 in Combination With R-GemOx Versus Placebo in Combination With R-GemOx in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","sponsor":"Hutchmed","started":"2026-03-20","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07464327","kind":"trial","name":"A Phase III Study of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-S","aka":[],"tldr":"A phase 3 trial of HS-20093 and docetaxel in lung cancer, run by Hansoh BioMedical R&D Company, not yet recruiting.","summary":"A Phase III Study of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations is a phase 3, randomised interventional study registered as NCT07464327 by Hansoh BioMedical R&D Company, with a registry enrolment figure of 450 participants, started 2026-03-31 and due to reach its primary completion in 2028-12-31. Interventions recorded: HS-20093; Docetaxel. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR); Overall survival (OS). Lung eligibility wording from the registry: \"Previously treated patients with histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07464327","url":"https://clinicaltrials.gov/study/NCT07464327"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["hs-20093","docetaxel"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07464327","phase":"3","setting":"A Multicenter, Randomized, Open-Label, Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations","sponsor":"Hansoh BioMedical R&D Company","started":"2026-03-31","startedType":"estimated","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06953999","kind":"trial","name":"A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial of Gemcitabine and Ivonescimab in pancreatic ductal adenocarcinoma, run by Akeso, now recruiting.","summary":"A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer is a phase 3 interventional study registered as NCT06953999 by Akeso, with 999 participants planned, started 2025-06-11 and due to reach its primary completion in 2027-05-14. Interventions recorded: Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine, Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine and Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06953999","url":"https://clinicaltrials.gov/study/NCT06953999"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["gemcitabine","ivonescimab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06953999","phase":"3","setting":"A Randomized, Controlled, Multi-center Phase III Clinical Study of Ivonescimab Plus Chemotherapy With or Without AK117 Versus Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer","sponsor":"Akeso","started":"2025-06-11","startedType":"actual","enrolled":999,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07533123","kind":"trial","name":"A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care","aka":[],"tldr":"A phase 3 trial testing JSKN016 in triple-negative breast cancer, now recruiting.","summary":"A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care is a phase 3 interventional study registered as NCT07533123, led by Jiangsu Alphamab Biopharmaceuticals, and recruiting on the registry. Official title: A Randomised, Controlled, Open-Label Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic Triple-Negative Breast Cancer Who Have Failed at Least Two Lines of Prior Systemic Therapy. Planned enrolment is 364 participants (estimated). The study started in 2026-03-17 and primary completion is expected in 2029-03-17. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07533123","url":"https://clinicaltrials.gov/study/NCT07533123"}],"tags":["ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["jskn016"],"companies":["alphamab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07533123","phase":"3","setting":"A Randomized, Controlled, Open-Label Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic Triple-Negative Breast Cancer Who Have Failed at Least Two Lines of Prior Systemic Therapy","sponsor":"Jiangsu Alphamab Biopharmaceuticals","started":"2026-03-17","startedType":"estimated","enrolled":364,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06747338","kind":"trial","name":"A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer","aka":[],"tldr":"A phase 3 trial testing HB1801 in HER2-positive breast cancer, active and no longer recruiting.","summary":"A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer is a phase 3 interventional study registered as NCT06747338, led by Shanghai JMT-Bio, and active but no longer recruiting on the registry. Official title: A Randomised, Controlled, Open-label, Multicenter, Phase III Clinical Trial to Compare the Efficacy and Safety of KN026 Combined With HB1801 ± Carboplatin Versus Trastuzumab Combined With Pertuzumab and Docetaxel ± Carboplatin in Neoadjuvant Treatment of Early or Locally Advanced HER2-positive Breast Cancer. Planned enrolment is 520 participants (estimated). The study started in 2024-12-16 and primary completion is expected in 2026-12-16. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06747338","url":"https://clinicaltrials.gov/study/NCT06747338"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["hb1801","kn026"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct06747338-jama-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06747338","phase":"3","setting":"A Randomized, Controlled, Open-label, Multicenter, Phase III Clinical Trial to Compare the Efficacy and Safety of KN026 Combined With HB1801 ± Carboplatin Versus Trastuzumab Combined With Pertuzumab and Docetaxel ± Carboplatin in Neoadjuvant Treatment of Early or Locally Advanced HER2-positive Breast Cancer","sponsor":"Shanghai JMT-Bio","started":"2024-12-16","startedType":"actual","enrolled":520,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07441460","kind":"trial","name":"A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer","aka":[],"tldr":"A phase 3 trial testing HB1801 in HER2-positive breast cancer, now recruiting.","summary":"A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer is a phase 3 interventional study registered as NCT07441460, led by Shanghai JMT-Bio, and recruiting on the registry. Official title: A Randomised, Controlled, Open-label, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of KN026 Combined With HB1801 and Chemotherapy Versus Trastuzumab Combined With Pertuzumab and Chemotherapy as Adjuvant Therapy in Resectable HER2-positive Breast Cancer. Planned enrolment is 1800 participants (estimated). The study started in 2026-03-06 and primary completion is expected in 2034-08-07. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07441460","url":"https://clinicaltrials.gov/study/NCT07441460"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["hb1801","kn026"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07441460","phase":"3","setting":"A Randomized, Controlled, Open-label, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of KN026 Combined With HB1801 and Chemotherapy Versus Trastuzumab Combined With Pertuzumab and Chemotherapy as Adjuvant Therapy in Resectable HER2-positive Breast Cancer","sponsor":"Shanghai JMT-Bio","started":"2026-03-06","startedType":"actual","enrolled":1800,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06764875","kind":"trial","name":"A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer","aka":["ARTEMIDE-Gastric01"],"tldr":"A phase 3 trial of Rilvegostomig, Trastuzumab deruxtecan, Trastuzumab, Pembrolizumab, Capecitabine and Cisplatin in gastric & gastro-oesophageal junction cancer, run by AstraZeneca, now recruiting.","summary":"A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer is a phase 3 interventional study registered as NCT06764875 by AstraZeneca, with 840 participants planned, started 2025-03-01 and due to reach its primary completion in 2029-04-27. Interventions recorded: Rilvegostomig, Trastuzumab deruxtecan, Trastuzumab, Pembrolizumab, 5-fluorouracil and Capecitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06764875","url":"https://clinicaltrials.gov/study/NCT06764875"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":["adc","checkpoint-inhibitor","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["rilvegostomig","trastuzumab-deruxtecan","trastuzumab","pembrolizumab","capecitabine","cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06764875","phase":"3","setting":"A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)","sponsor":"AstraZeneca","started":"2025-03-01","startedType":"actual","enrolled":840,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07229625","kind":"trial","name":"A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)","aka":[],"tldr":"A phase 3 trial testing SHR-8068 in biliary tract cancer, now recruiting.","summary":"A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC) is a phase 3 interventional study registered as NCT07229625, led by Suzhou Suncadia Biopharmaceuticals, and recruiting on the registry. Official title: A Phase III, Randomised, Controlled, Open-Label, Multicenter Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-Line Treatment for Advanced Biliary Tract Cancer (BTC). Planned enrolment is 604 participants (estimated). The study started in 2026-01-21 and primary completion is expected in 2029-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07229625","url":"https://clinicaltrials.gov/study/NCT07229625"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-8068"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07229625","phase":"3","setting":"A Phase III, Randomized, Controlled, Open-Label, Multicenter Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-Line Treatment for Advanced Biliary Tract Cancer (BTC)","sponsor":"Suzhou Suncadia Biopharmaceuticals","started":"2026-01-21","startedType":"actual","enrolled":604,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06057610","kind":"trial","name":"A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial of Trastuzumab rezetecan, Pertuzumab, Docetaxel and Trastuzumab in HER2-positive breast cancer, run by Jiangsu HengRui Medicine Co., Ltd., active and no longer recruiting.","summary":"A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer is a phase 3 interventional study registered as NCT06057610 by Jiangsu HengRui Medicine Co., Ltd., with 868 participants enrolled, started 2023-11-01 and due to reach its primary completion in 2026-07-15. Interventions recorded: SHR-A1811 Injection, SHR-A1811 Injection ； Pertuzumab Injection and Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06057610","url":"https://clinicaltrials.gov/study/NCT06057610"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","pertuzumab","docetaxel","trastuzumab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06057610","phase":"3","setting":"A Phase III Multicenter, Randomized, Open-label, Active-Controlled Study of SHR-A1811 With or Without Pertuzumab Versus Trastuzumab, Pertuzumab and Docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2023-11-01","startedType":"actual","enrolled":868,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05870319","kind":"trial","name":"A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients","aka":[],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Pemetrexed, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients is a phase 3 interventional study registered as NCT05870319 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 376 participants enrolled, started 2023-06-26 and due to reach its primary completion in 2024-07-11. Interventions recorded: SKB264, Pemetrexed, Carboplatin, Cisplatin. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05870319","url":"https://clinicaltrials.gov/study/NCT05870319"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["sacituzumab-tirumotecan","pemetrexed","carboplatin","cisplatin"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05870319-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05870319","phase":"3","setting":"A Randomized, Open-Label, Multicenter Phase 3 Study to Evaluate SKB264 Monotherapy Versus Pemetrexed in Combination With Platinum in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2023-06-26","startedType":"actual","enrolled":376,"enrolledBasis":"registry","outcomes":[]},{"id":"taishan-301","kind":"trial","name":"A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma(TAISHAN-301)","aka":["TAISHAN-301"],"tldr":"A phase 3 trial testing YL201 in nasopharyngeal carcinoma, active and no longer recruiting.","summary":"A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma(TAISHAN-301) is a phase 3 interventional study registered as NCT06629597, led by MediLink Therapeutics (Suzhou), and active but no longer recruiting on the registry. Official title: A Randomised, Controlled, Multicenter Phase III Clinical Study of YL201 Versus Investigator's Choice of Chemotherapy in Subjects With Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Failed Prior PD-(L)1 Inhibitor and at Least Two Lines of Chemotherapy. Planned enrolment is 400 participants (estimated). The study started in 2024-12-31 and primary completion is expected in 2027-12-01. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06629597","url":"https://clinicaltrials.gov/study/NCT06629597"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nasopharyngeal","recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["yl201"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06629597","phase":"3","setting":"A Randomized, Controlled, Multicenter Phase III Clinical Study of YL201 Versus Investigator's Choice of Chemotherapy in Subjects With Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Failed Prior PD-(L)1 Inhibitor and at Least Two Lines of Chemotherapy","sponsor":"MediLink Therapeutics (Suzhou)","started":"2024-12-31","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06612151","kind":"trial","name":"A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer（TAISHAN-302）","aka":["TAISHAN-302"],"tldr":"A phase 3 trial testing YL201 in non-small-cell lung cancer, active and no longer recruiting.","summary":"A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer（TAISHAN-302） is a phase 3 interventional study registered as NCT06612151, led by MediLink Therapeutics (Suzhou), and active but no longer recruiting on the registry. Official title: A Multicenter, Randomised, Controlled, Open-label, Phase III Study to Compare the Efficacy and Safety of YL201 Versus Topotecan Hydrochloride in Subjects With Relapsed Small Cell Lung Cancer. Planned enrolment is 438 participants (estimated). The study started in 2024-12-17 and primary completion is expected in 2027-12-01. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06612151","url":"https://clinicaltrials.gov/study/NCT06612151"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["yl201"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct06612151-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06612151","phase":"3","setting":"A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Compare the Efficacy and Safety of YL201 Versus Topotecan Hydrochloride in Subjects With Relapsed Small Cell Lung Cancer","sponsor":"MediLink Therapeutics (Suzhou)","started":"2024-12-17","startedType":"actual","enrolled":438,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04951635","kind":"trial","name":"A Phase III Study to Assess the Effects of Almonertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of Aumolertinib in non-small-cell lung cancer and small-cell lung cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd., now recruiting.","summary":"A Phase III Study to Assess the Effects of Almonertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT04951635 by Jiangsu Hansoh Pharmaceutical Co., Ltd., with 150 participants planned, started 2021-03-18 and due to reach its primary completion in 2024-07-15. Interventions recorded: Almonertinib, Placebo Almonertinib. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04951635","url":"https://clinicaltrials.gov/study/NCT04951635"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["aumolertinib"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04951635","phase":"3","setting":"A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre Study of Almonertinib as Maintenance Therapy in Patients With Locally Advanced, Unresectable EGFR Mutation-positive Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based Chemoradiation Therapy","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","started":"2021-03-18","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07816380","kind":"trial","name":"A Phase III Study to Evaluate the Efficacy and Safety of JYP0322 in Previously Untreated ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Guangzhou JOYO Pharma Co., Ltd, not yet recruiting.","summary":"A Phase III Study to Evaluate the Efficacy and Safety of JYP0322 in Previously Untreated ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT07816380 by Guangzhou JOYO Pharma Co., Ltd, with a registry enrolment figure of 216 participants, started 2026-10-30 and due to reach its primary completion in 2028-12-30. Interventions recorded: JYP0322 Tablets; Crizotinib Capsules. Conditions listed: NSCLC (Advanced Non-small Cell Lung Cancer). Primary outcome: Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR/BIRC) per RECIST v1.1. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed, unresectable locally advanced (AJCC 9th edition stage IIIB or IIIC not amenable to multimodality therapy) or metastatic (stage IV) ROS1-positive non-small cell lung cancer (NSCLC)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07816380","url":"https://clinicaltrials.gov/study/NCT07816380"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["ros1-positive-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07816380","phase":"3","setting":"A Randomized, Open-Label, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of JYP0322 Versus Crizotinib in Previously Untreated ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Guangzhou JOYO Pharma Co., Ltd","started":"2026-10-30","startedType":"estimated","enrolled":216,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06465914","kind":"trial","name":"A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males","aka":[],"tldr":"A phase 3 trial of HPV quadrivalent vaccine in penile cancer, run by Shanghai Bovax Biotechnology Co., Ltd., active and no longer recruiting.","summary":"A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males is a phase 3 interventional study registered as NCT06465914 by Shanghai Bovax Biotechnology Co., Ltd., with 9000 participants enrolled, started 2024-07-11 and due to reach its primary completion in 2027-07-30. Interventions recorded: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha), Placebo. Conditions listed: Genital Wart, Penile Cancer, Anal Cancer, PIN-1. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06465914","url":"https://clinicaltrials.gov/study/NCT06465914"}],"tags":["ctgov-ingest"],"related":[],"cancers":["penile","localised-penile-cancer"],"sections":[],"technologies":["hpv-vaccine","interception-vaccination"],"targets":[],"drugs":["hpv-quadrivalent-vaccine"],"companies":["shanghai-bovax-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06465914","phase":"3","setting":"A Randomized, Double-blinded, Multicenter and Placebo-controlled Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Recombinant Vaccine (Hansenula Polymorpha) in Chinese Males Aged 18-45 Years","sponsor":"Shanghai Bovax Biotechnology Co., Ltd.","started":"2024-07-11","startedType":"actual","enrolled":9000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06908304","kind":"trial","name":"A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC","aka":[],"tldr":"A phase 3 trial of Cemiplimab, Docetaxel, Vinorelbine and Gemcitabine in non-small-cell lung cancer, run by Maia Biotechnology, now recruiting.","summary":"A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC is a phase 3 interventional study registered as NCT06908304 by Maia Biotechnology, with 300 participants planned, started 2025-12-08 and due to reach its primary completion in 2027-07-31. Interventions recorded: 6-Thio-2'-Deoxyguanosine, Cemiplimab, Docetaxel, Vinorelbine and Gemcitabine alone.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06908304","url":"https://clinicaltrials.gov/study/NCT06908304"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab","docetaxel","vinorelbine","gemcitabine"],"companies":["maia-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06908304","phase":"3","setting":"A Multicenter, Open-label, Randomized Phase 3 Study of THIO Sequenced With Cemiplimab (LIBTAYO®) vs Investigator's Choice of Chemotherapy as Third-line Treatment in Advanced/Metastatic NSCLC","sponsor":"Maia Biotechnology","started":"2025-12-08","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07349069","kind":"trial","name":"A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer","aka":[],"tldr":"A phase 3 trial testing HRS-8080 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer is a phase 3 interventional study registered as NCT07349069, led by Shandong Suncadia Medicine, and recruiting on the registry. Official title: A Randomised, Open-Label, Phase III Trial to Compare HRS-8080 Versus Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer Who Have Received at Least 2 Years of Standard Adjuvant Endocrine Therapy. Planned enrolment is 5500 participants (estimated). The study started in 2026-03-04 and primary completion is expected in 2030-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07349069","url":"https://clinicaltrials.gov/study/NCT07349069"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["hrs-8080"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07349069","phase":"3","setting":"A Randomized, Open-Label, Phase III Trial to Compare HRS-8080 Versus Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer Who Have Received at Least 2 Years of Standard Adjuvant Endocrine Therapy","sponsor":"Shandong Suncadia Medicine","started":"2026-03-04","startedType":"actual","enrolled":5500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05888493","kind":"trial","name":"A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma","aka":["LEDA"],"tldr":"A phase 3 trial of Tisagenlecleucel, Lenalidomide, Rituximab in follicular lymphoma, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma is a phase 3 interventional study registered as NCT05888493 by Novartis Pharmaceuticals, with 109 participants enrolled, started 2023-10-02 and due to reach its primary completion in 2028-07-25. Interventions recorded: Tisagenlecleucel, Lenalidomide and rituximab (R2) in 28-day cycles for up to 12 cycles., Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone (R-CHOP) in 21-day cycles for 6 to 8 cycles, Lymphodepleting chemotherapy, Corticosteroids and/or Radiation (Bridging therapy). Conditions listed: Follicular Lymphoma (FL). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05888493","url":"https://clinicaltrials.gov/study/NCT05888493"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["tisagenlecleucel","lenalidomide","rituximab","cyclophosphamide","doxorubicin","vincristine"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05888493","phase":"3","setting":"A Randomized, Open-label, Multi-center Phase III Trial Comparing Tisagenlecleucel to Standard of Care in Adult Participants With Relapsed or Refractory Follicular Lymphoma (FL)","sponsor":"Novartis Pharmaceuticals","started":"2023-10-02","startedType":"actual","enrolled":109,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07365995","kind":"trial","name":"A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer","aka":[],"tldr":"A phase 3 trial testing BNT324 in prostate cancer, now recruiting.","summary":"A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer is a phase 3 interventional study registered as NCT07365995, led by BioNTech SE with BioNTech (Shanghai) Pharmaceuticals and DualityBio, and recruiting on the registry. Official title: A Phase III, Randomised, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer. Planned enrolment is 736 participants (estimated). The study started in 2026-04-22 and primary completion is expected in 2031-02. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07365995","url":"https://clinicaltrials.gov/study/NCT07365995"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["bnt324"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07365995","phase":"3","setting":"A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer","sponsor":"BioNTech SE","started":"2026-04-22","startedType":"actual","enrolled":736,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06126640","kind":"trial","name":"A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy","aka":[],"tldr":"A phase 3 trial of Trastuzumab rezetecan and Trastuzumab emtansine in HER2-positive breast cancer, run by Jiangsu HengRui Medicine Co., Ltd., active and no longer recruiting.","summary":"A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy is a phase 3 interventional study registered as NCT06126640 by Jiangsu HengRui Medicine Co., Ltd., with 1615 participants enrolled, started 2023-11-20 and due to reach its primary completion in 2030-04. Interventions recorded: SHR-A1811 and Trastuzumab Emtansine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06126640","url":"https://clinicaltrials.gov/study/NCT06126640"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","trastuzumab-emtansine"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06126640","phase":"3","setting":"A Phase III, Multicenter, Randomized, Open-Label, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2023-11-20","startedType":"actual","enrolled":1615,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06564844","kind":"trial","name":"A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following C","aka":["TROPION-Lung12"],"tldr":"A phase 3 trial of Datopotamab deruxtecan, Rilvegostomig, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features is a phase 3 interventional study registered as NCT06564844 by AstraZeneca, with 25 participants enrolled, started 2024-10-15 and due to reach its primary completion in 2027-06-30. Interventions recorded: Datopotamab Deruxtecan, Rilvegostomig, Carboplatin, Cisplatin, Etoposide. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06564844","url":"https://clinicaltrials.gov/study/NCT06564844"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan","rilvegostomig","carboplatin","cisplatin","etoposide","pemetrexed"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06564844","phase":"3","setting":"A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)","sponsor":"AstraZeneca","started":"2024-10-15","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07336953","kind":"trial","name":"A Phase III, Randomized, Clinical Trial of GnP Combined With SBRT and Serplulimab Versus GnP as First-Line Treatment for Patients With Recurrent or Metastatic P","aka":["ICSBR-2"],"tldr":"A phase 3 trial of gemcitabine + nab-paclitaxel and serplulimab in pancreatic cancer, run by West China Hospital, not yet recruiting.","summary":"A Phase III, Randomized, Clinical Trial of GnP Combined With SBRT and Serplulimab Versus GnP as First-Line Treatment for Patients With Recurrent or Metastatic Pancreatic Cancer (WGOG-PAN 006/ICSBR-2) is a phase 3, randomised interventional study registered as NCT07336953 by West China Hospital, with a registry enrolment figure of 198 participants, started 2026-02 and due to reach its primary completion in 2027-07. Interventions recorded: GnP; SBRT; Serplulimab. Conditions listed: PDAC - Pancreatic Ductal Adenocarcinoma. Primary outcome: Overall Survival (OS). Pancreatic eligibility wording from the registry: \"Patients with pathologically confirmed metastatic pancreatic cancer who are inoperable, with diagnosis based on a comprehensive assessment of pathology and imaging studies (CT or MRI);\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07336953","url":"https://clinicaltrials.gov/study/NCT07336953"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","sbrt"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel","serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07336953","phase":"3","setting":"A Randomized, Controlled, Phase III Study of Gemcitabine and Nab-paclitaxel (GnP) Combined With Stereotactic Body Radiation Therapy (SBRT) and Serplulimab Versus GnP as First-Line Therapy in Patients With Recurrent or Metastatic Pancreatic Cancer (WGOG-PAN 006/ICSBR-2)","sponsor":"West China Hospital","started":"2026-02","startedType":"estimated","enrolled":198,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03246529","kind":"trial","name":"A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Pl","aka":["GENESIS"],"tldr":"A phase 3 trial of Filgrastim in multiple myeloma, run by BioLineRx, Ltd., active and no longer recruiting.","summary":"A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM) is a phase 3 interventional study registered as NCT03246529 by BioLineRx, Ltd., with 180 participants enrolled, started 2018-03-23 and due to reach its primary completion in 2020-12-22. Interventions recorded: BL-8040 1.25 mg/kg + G-CSF, Placebo +G-CSF. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03246529","url":"https://clinicaltrials.gov/study/NCT03246529"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["g-csf-growth-factors"],"targets":[],"drugs":["filgrastim"],"companies":["biolinerx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03246529","phase":"3","setting":"A Phase III, Randomized, Placebo-Controlled, Multi-Centre Study Evaluating the Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma - The GENESIS Study","sponsor":"BioLineRx, Ltd.","started":"2018-03-23","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07647328","kind":"trial","name":"A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer","aka":["SERAFA-1"],"tldr":"A phase 3 trial of Camizestrant and Ribociclib in HR-positive / HER2-negative breast cancer, run by AstraZeneca, now recruiting.","summary":"A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer is a phase 3 interventional study registered as NCT07647328 by AstraZeneca, with 150 participants planned, started 2026-06-15 and due to reach its primary completion in 2029-02-28. Interventions recorded: Camizestrant and Ribociclib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07647328","url":"https://clinicaltrials.gov/study/NCT07647328"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy"],"targets":[],"drugs":["camizestrant","ribociclib"],"companies":["astrazeneca","icon-plc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07647328","phase":"3","setting":"SERAFA-1: A Single Arm, Open Label, Multicentre, Phase IIIb Study Of Camizestrant Plus Ribociclib in 1st Line Treatment of ER Positive, HER2-negative Advanced Breast Cancer Patients","sponsor":"AstraZeneca","started":"2026-06-15","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06764186","kind":"trial","name":"A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain","aka":["CAPItana"],"tldr":"A phase 3 trial of Fulvestrant and Capivasertib in advanced solid tumours, run by AstraZeneca, active and no longer recruiting.","summary":"A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain is a phase 3 interventional study registered as NCT06764186 by AstraZeneca, with 101 participants enrolled, started 2025-01-07 and due to reach its primary completion in 2027-12-31. Interventions recorded: Fulvestrant and Capivasertib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06764186","url":"https://clinicaltrials.gov/study/NCT06764186"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy","kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["fulvestrant","capivasertib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06764186","phase":"3","setting":"A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With HR+ / HER2- Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain","sponsor":"AstraZeneca","started":"2025-01-07","startedType":"actual","enrolled":101,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06247605","kind":"trial","name":"A Phase IIII Study of AL8326 in Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial testing AL8326 in small-cell lung cancer and non-small-cell lung cancer, now recruiting.","summary":"A Phase IIII Study of AL8326 in Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06247605, led by Advenchen Laboratories Nanjing, and recruiting on the registry. Official title: Phase III Clinical Study of AL8326 Tablets in Patients With Advanced or Recurrent Small Cell Lung Cancer After at Least Prior Second-line Treatment. Planned enrolment is 243 participants (estimated). The study started in 2023-10-26 and primary completion is expected in 2028-07. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06247605","url":"https://clinicaltrials.gov/study/NCT06247605"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["al8326"],"companies":["advenchen-laboratories"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06247605","phase":"3","setting":"Phase III Clinical Study of AL8326 Tablets in Patients With Advanced or Recurrent Small Cell Lung Cancer After at Least Prior Second-line Treatment","sponsor":"Advenchen Laboratories Nanjing","started":"2023-10-26","startedType":"actual","enrolled":243,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06919510","kind":"trial","name":"A Phase ll Study of Neoadjuvant Short-course Radiotherapy Followed by Ivonescimab and Chemotherapy in pMMR/MSS Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"A Phase ll Study of Neoadjuvant Short-course Radiotherapy Followed by Ivonescimab and Chemotherapy in pMMR/MSS Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT06919510 by Sun Yat-sen University, with a registry enrolment figure of 90 participants, started 2025-04-01 and due to reach its primary completion in 2026-06-01. Interventions recorded: lvonescimab; CAPOX (oxaliplatin/capecitabine); radiotherapy; Surgery or watch&wait. Conditions listed: Rectal Adenocarcinoma. Primary outcome: Adverse events; Complete response rate; Clinical complete response rate. Colorectal eligibility wording from the registry: \"Histologically proven rectal adenocarcinoma;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06919510","url":"https://clinicaltrials.gov/study/NCT06919510"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capox"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06919510","phase":"2","setting":"A Phase ll Study of Neoadjuvant Short-course Radiotherapy Followed by Lvonescimab and Chemotherapy Versus Neoadjuvant Short-course Radiotherapy Followed by Chemotherapy in pMMR/MSS Locally Advanced Rectal Cancer","sponsor":"Sun Yat-sen University","started":"2025-04-01","startedType":"estimated","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07689955","kind":"trial","name":"A Phase-II Clinical Trial of Radiotherapy to the Coeliac Plexus to Help Pain in Advanced Pancreatic Cancer","aka":["PANCPLEX"],"tldr":"A phase 2 trial in pancreatic cancer, run by Royal Marsden NHS Foundation Trust, not yet recruiting.","summary":"A Phase-II Clinical Trial of Radiotherapy to the Coeliac Plexus to Help Pain in Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT07689955 by Royal Marsden NHS Foundation Trust, with a registry enrolment figure of 52 participants, started 2026-09 and due to reach its primary completion in 2029-09. Interventions recorded: IMRT. Conditions listed: Pancreatic Cancer. Primary outcome: To assess the clinical benefit of IMRT radiotherapy to the coeliac plexus in achieving a clinically meaningful reduction in participant-reported pain in participants with inoperable advanced pancreatic adenocarcinoma.. Pancreatic eligibility wording from the registry: \"Pain with a BPI score ≥ 2 as a result of pancreatic adenocarcinoma, not sufficiently responding to opiate medication\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07689955","url":"https://clinicaltrials.gov/study/NCT07689955"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07689955","phase":"2","setting":"A Multi-Centre, Single-Arm Prospective Phase II Clinical Trial of Radiotherapy to the Coeliac Plexus to Help Pain in Advanced Pancreatic Cancer","sponsor":"Royal Marsden NHS Foundation Trust","started":"2026-09","startedType":"estimated","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07239466","kind":"trial","name":"A Pilot Study Evaluating β-hydroxybutyrate Supplementation Concomitant to Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant T","aka":[],"tldr":"A phase 2 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Tao Zhang, now recruiting.","summary":"A Pilot Study Evaluating β-hydroxybutyrate Supplementation Concomitant to Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT07239466 by Tao Zhang, with a registry enrolment figure of 25 participants, started 2026-01-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: Short-course radiotherapy; Capecitabine; Oxaliplatin; TME surgery; β-hydroxybutyrate. Conditions listed: Rectal Cancer; Radiotherapy; Immunotherapy; Chemotherapy. Primary outcome: complete response (CR) rate. Colorectal eligibility wording from the registry: \"Histologically confirmed Locally Advanced rectal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07239466","url":"https://clinicaltrials.gov/study/NCT07239466"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07239466","phase":"2","setting":"A Single-Arm, Single-Center Study of Exploring the β-hydroxybutyrate Supplementation and Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy in Locally Advanced Rectal Cancer","sponsor":"Tao Zhang","started":"2026-01-01","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06764940","kind":"trial","name":"A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases","aka":[],"tldr":"A phase 2 trial of Capecitabine in brain and spinal cord tumours, run by Biostar Pharma, Inc., now recruiting.","summary":"A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases is a phase 2 interventional study registered as NCT06764940 by Biostar Pharma, Inc., with 120 participants planned, started 2025-07-14 and due to reach its primary completion in 2027-01-15. Interventions recorded: Utidelone and Utidelone in combination with capecitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06764940","url":"https://clinicaltrials.gov/study/NCT06764940"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["brain-tumours","secondary-brain-tumours"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine","utidelone"],"companies":["biostar-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06764940","phase":"2","setting":"A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients With Brain Metastases","sponsor":"Biostar Pharma, Inc.","started":"2025-07-14","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06389292","kind":"trial","name":"A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia","aka":["GLORA-3"],"tldr":"A phase 3 trial of Azacitidine in acute myeloid leukaemia, run by Ascentage Pharma Group Inc., now recruiting.","summary":"A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia is a phase 3 interventional study registered as NCT06389292 by Ascentage Pharma Group Inc., with 486 participants planned, started 2024-06-11 and due to reach its primary completion in 2028-05-25. Interventions recorded: APG-2575(Lisaftoclax ) and Azacitidine Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06389292","url":"https://clinicaltrials.gov/study/NCT06389292"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-older-unfit"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["azacitidine"],"companies":["ascentage-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06389292","phase":"3","setting":"A Global, Multicenter, Randomized, Double-blind, Phase 3 Pivotal Registrational Clinical Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (GLORA-3)","sponsor":"Ascentage Pharma Group Inc.","started":"2024-06-11","startedType":"actual","enrolled":486,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03899636","kind":"trial","name":"A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer","aka":["DIRECT"],"tldr":"A phase 3 trial of Modified FOLFIRINOX Regimen in pancreatic ductal adenocarcinoma, run by Angiodynamics, Inc., active and no longer recruiting.","summary":"A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer is a phase 3 interventional study registered as NCT03899636 by Angiodynamics, Inc., with 528 participants enrolled, started 2021-02-23 and due to reach its primary completion in 2025-04. Interventions recorded: Modified FOLFIRINOX Regimen and NanoKnife System.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03899636","url":"https://clinicaltrials.gov/study/NCT03899636"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":["irreversible-electroporation"],"targets":[],"drugs":[],"companies":["angiodynamics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03899636","phase":"3","setting":"A Randomized, Multicenter, Controlled, Unblinded Study to Assess the Safety and Efficacy of the NanoKnife® System for the Ablation of Unresectable Stage 3 Pancreatic Adenocarcinoma","sponsor":"Angiodynamics, Inc.","started":"2021-02-23","startedType":"actual","enrolled":528,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06996782","kind":"trial","name":"A Platform Study in Non-Small Cell Lung Cancer (NSCLC)","aka":["ALTAIR"],"tldr":"A phase 1/2 trial of Rilvegostomig, Cisplatin, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, now recruiting.","summary":"A Platform Study in Non-Small Cell Lung Cancer (NSCLC) is a phase 1/2 interventional study registered as NCT06996782 by AstraZeneca, with 152 participants planned, started 2025-11-24 and due to reach its primary completion in 2029-02-23. Interventions recorded: Rilvegostomig, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel. Conditions listed: Advanced or Metastatic Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06996782","url":"https://clinicaltrials.gov/study/NCT06996782"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["rilvegostomig","cisplatin","carboplatin","pemetrexed","paclitaxel","ramucirumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06996782","phase":"1/2","setting":"A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"AstraZeneca","started":"2025-11-24","startedType":"actual","enrolled":152,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06062420","kind":"trial","name":"A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202","aka":[],"tldr":"A phase 2 trial of Dostarlimab in head and neck squamous cell carcinoma, run by GlaxoSmithKline, active and no longer recruiting.","summary":"A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202 is a phase 2 interventional study registered as NCT06062420 by GlaxoSmithKline, with 316 participants enrolled, started 2023-11-14 and due to reach its primary completion in 2026-09-01. Interventions recorded: Dostarlimab, Belrestotug, Nelistotug and Remzistotug.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06062420","url":"https://clinicaltrials.gov/study/NCT06062420"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06062420","phase":"2","setting":"A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck","sponsor":"GlaxoSmithKline","started":"2023-11-14","startedType":"actual","enrolled":316,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05565378","kind":"trial","name":"A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Pembrolizumab and Dostarlimab in non-small-cell lung cancer, run by GlaxoSmithKline, active and no longer recruiting.","summary":"A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer is a phase 2 interventional study registered as NCT05565378 by GlaxoSmithKline, with 351 participants enrolled, started 2022-10-14 and due to reach its primary completion in 2026-11-09. Interventions recorded: Pembrolizumab, Dostarlimab, Belrestotug and Nelistotug.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05565378","url":"https://clinicaltrials.gov/study/NCT05565378"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","dostarlimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05565378","phase":"2","setting":"A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants With Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer","sponsor":"GlaxoSmithKline","started":"2022-10-14","startedType":"actual","enrolled":351,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06140524","kind":"trial","name":"A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With H","aka":["LINKER-MGUS1"],"tldr":"A phase 2 trial of Linvoseltamab in multiple myeloma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma is a phase 2 interventional study registered as NCT06140524 by Regeneron Pharmaceuticals, with 116 participants planned, started 2024-09-16 and due to reach its primary completion in 2032-05-18. Interventions recorded: Linvoseltamab. Conditions listed: Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06140524","url":"https://clinicaltrials.gov/study/NCT06140524"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","smouldering-myeloma"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["linvoseltamab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06140524","phase":"2","setting":"Phase 2 Dose-Ranging and Interception Study of Linvoseltamab in Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma","sponsor":"Regeneron Pharmaceuticals","started":"2024-09-16","startedType":"actual","enrolled":116,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05955508","kind":"trial","name":"A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Adult Participants With Smoldering Multiple Myeloma at High Risk of Deve","aka":[],"tldr":"A phase 2 trial of Linvoseltamab in multiple myeloma, run by Regeneron Pharmaceuticals, active and no longer recruiting.","summary":"A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Adult Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma is a phase 2 interventional study registered as NCT05955508 by Regeneron Pharmaceuticals, with 40 participants enrolled, started 2024-01-30 and due to reach its primary completion in 2033-01-25. Interventions recorded: Linvoseltamab. Conditions listed: Smoldering Multiple Myeloma (SMM). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05955508","url":"https://clinicaltrials.gov/study/NCT05955508"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","smouldering-myeloma"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["linvoseltamab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05955508","phase":"2","setting":"Phase 2 Study of Linvoseltamab in Patients With Smoldering Multiple Myeloma at High Risk of Progression to Multiple Myeloma","sponsor":"Regeneron Pharmaceuticals","started":"2024-01-30","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06972498","kind":"trial","name":"A Prospective Multicenter Study: Ivosimab + Chemotherapy as Neoadjuvant for Resectable pMMR/MSS CRC Liver Mets","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine, not yet recruiting.","summary":"A Prospective Multicenter Study: Ivosimab + Chemotherapy as Neoadjuvant for Resectable pMMR/MSS CRC Liver Mets is a phase 2, interventional study registered as NCT06972498 by The Fourth Affiliated Hospital of Zhejiang University School of Medicine, with a registry enrolment figure of 35 participants, started 2025-07-01 and due to reach its primary completion in 2027-12-30. Interventions recorded: Patients will receive ivosimab combined with the XELOX/FOLFOX regimen, followed by radical surgery 4-6 weeks after the last dose; adjuvant chemotherapy will continue for 3 months postoperatively.. Conditions listed: Colorectal Cancer With Liver Metastasis. Primary outcome: ORR. Colorectal eligibility wording from the registry: \"Patients with pathologically or cytologically confirmed colorectal adenocarcinoma liver metastasis, and immunohistochemistry or genetic testing confirms pMMR/MSS\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06972498","url":"https://clinicaltrials.gov/study/NCT06972498"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06972498","phase":"2","setting":"A Prospective, Single-Arm, Multicenter Clinical Study on the Efficacy and Safety of Ivosimab Combined With Chemotherapy as Neoadjuvant Therapy in Patients With Resectable pMMR/MSS Colorectal Cancer Liver Metastases","sponsor":"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","started":"2025-07-01","startedType":"estimated","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06496971","kind":"trial","name":"A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubble-mediated Focused Ultrasound (FUS-MB) Using NaviFUS System in Recurrent Glioblastoma Multiforme Patients","aka":[],"tldr":"A phase 3 trial of Bevacizumab in glioma & glioblastoma and brain and spinal cord tumours, run by NaviFUS Corporation, now recruiting.","summary":"A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubble-mediated Focused Ultrasound (FUS-MB) Using NaviFUS System in Recurrent Glioblastoma Multiforme Patients is a phase 3 interventional study registered as NCT06496971 by NaviFUS Corporation, with 32 participants planned, started 2024-11-08 and due to reach its primary completion in 2026-12-31. Interventions recorded: Bevacizumab, Microbubble and Low-Intensity Focused Ultrasound.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06496971","url":"https://clinicaltrials.gov/study/NCT06496971"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma","brain-tumours"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06496971","phase":"3","setting":"A Prospective, Randomized, Standard of Care Controlled, Parallel, Open-Label, Multicenter Pivotal Study to Evaluate the Efficacy and Safety of Avastin® in Combination With NaviFUS System Compared With Avastin® Alone for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)","sponsor":"NaviFUS Corporation","started":"2024-11-08","startedType":"actual","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06513221","kind":"trial","name":"A Prospective Study of MSS-type Metastatic Colorectal Cancer Receiving Multiple Lines of Standard Chemotherapy, Bevacizumab Combined With Adebrelimab","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"A Prospective Study of MSS-type Metastatic Colorectal Cancer Receiving Multiple Lines of Standard Chemotherapy, Bevacizumab Combined With Adebrelimab is a phase 2, interventional study registered as NCT06513221 by Fudan University, with a registry enrolment figure of 100 participants, started 2024-07-25 and due to reach its primary completion in 2026-04-01. Interventions recorded: Chemotherapy, Bevacizumab, Adebrelimab. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Objective Response Rate. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06513221","url":"https://clinicaltrials.gov/study/NCT06513221"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06513221","phase":"2","setting":"A Prospective, Multi-arm, Phase II Clinical Study of MSS-type Metastatic Colorectal Cancer Receiving Multiple Lines of Standard Chemotherapy, Bevacizumab Combined With Adebrelimab Under the Guidance of Transcriptome Profiling.","sponsor":"Fudan University","started":"2024-07-25","startedType":"estimated","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07101627","kind":"trial","name":"A Prospective, Multicenter Clinical Study of Hetrombopag in the Prevention of Thrombocytopenia Caused by Lung Cancer Therapy","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Shanghai Pulmonary Hospital, Shanghai, China, not yet recruiting.","summary":"A Prospective, Multicenter Clinical Study of Hetrombopag in the Prevention of Thrombocytopenia Caused by Lung Cancer Therapy is a phase 2, randomised interventional study registered as NCT07101627 by Shanghai Pulmonary Hospital, Shanghai, China, with a registry enrolment figure of 149 participants, started 2025-08-01 and due to reach its primary completion in 2027-04-30. Interventions recorded: Hetrombopag Tablets. Conditions listed: Lung Cancer. Primary outcome: Incidence of Grade 3 and Higher Thrombocytopenia. Lung eligibility wording from the registry: \"Patients with histopathologically confirmed metastatic lung cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07101627","url":"https://clinicaltrials.gov/study/NCT07101627"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07101627","phase":"2","setting":"A Prospective, Multicenter Clinical Study of Hetrombopag in the Prevention of Thrombocytopenia Caused by Lung Cancer Therapy","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","started":"2025-08-01","startedType":"estimated","enrolled":149,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07543848","kind":"trial","name":"A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemot","aka":[],"tldr":"A phase 2 trial of serplulimab in colorectal cancer, run by Chongqing University Cancer Hospital, not yet recruiting.","summary":"A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal Cancer is a phase 2, interventional study registered as NCT07543848 by Chongqing University Cancer Hospital, with a registry enrolment figure of 20 participants, started 2026-05-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: Serplulimab; Oncolytic Virus H101; XELOX Chemotherapy; Short-course Radiotherapy. Conditions listed: Rectal Neoplasms; Rectal Adenocarcinoma. Primary outcome: 1-year Clinical Complete Response Rate. Colorectal eligibility wording from the registry: \"Histologically confirmed low rectal adenocarcinoma, with tumor located ≤5 cm from the anal verge\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07543848","url":"https://clinicaltrials.gov/study/NCT07543848"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07543848","phase":"2","setting":"A Prospective, Multicenter, Single-Arm Phase II Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (cT1-3N0M0)","sponsor":"Chongqing University Cancer Hospital","started":"2026-05-01","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06746545","kind":"trial","name":"A Prospective, Open-label, Single-arm Phase II Clinical Study of Fruquintinib Combined With S-1 for the Treatment of Metastatic Colorectal Cancer.","aka":[],"tldr":"A phase 2 trial of fruquintinib in colorectal cancer, run by Fujian Cancer Hospital, not yet recruiting.","summary":"A Prospective, Open-label, Single-arm Phase II Clinical Study of Fruquintinib Combined With S-1 for the Treatment of Metastatic Colorectal Cancer. is a phase 2, interventional study registered as NCT06746545 by Fujian Cancer Hospital, with a registry enrolment figure of 30 participants, started 2025-02-01 and due to reach its primary completion in 2026-08-01. Interventions recorded: Fruquintinib+S-1. Conditions listed: Colorectal Cancer. Primary outcome: Progression free survival (PFS). Colorectal eligibility wording from the registry: \"Confirmed advanced metastatic colorectal adenocarcinoma by histopathological examination;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06746545","url":"https://clinicaltrials.gov/study/NCT06746545"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06746545","phase":"2","setting":"A Prospective, Open-label, Single-arm Phase II Clinical Study of Fruquintinib Combined With S-1 for the Treatment of Metastatic Colorectal Cancer.","sponsor":"Fujian Cancer Hospital","started":"2025-02-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04501523","kind":"trial","name":"A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC","aka":["Apollo"],"tldr":"A phase 2 trial of tislelizumab and capecitabine in triple-negative breast cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, now recruiting.","summary":"A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC is a phase 2, randomised interventional study registered as NCT04501523 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, with a registry enrolment figure of 460 participants, started 2020-08-03 and due to reach its primary completion in 2027-08. Interventions recorded: Tislelizumab; capecitabine. Conditions listed: Triple-negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, clinical stage II-III at diagnosis (AJCC 6th edition) based on initial evaluation by physical examination and/or breast imaging prior to study registration\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04501523","url":"https://clinicaltrials.gov/study/NCT04501523"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["tislelizumab","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04501523","phase":"2","setting":"A Prospective, Phase II Trial Using Circulating Tumor DNA to Initiate Post-operation Boost Therapy After Neoadjuvant Chemotherapy in Triple-negative Breast Cancer","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","started":"2020-08-03","startedType":"actual","enrolled":460,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07471165","kind":"trial","name":"A Prospective, Single-Arm, Phase II Study: PD-L1 Monoclonal Antibody + Chemoradiotherapy as Bridge Therapy to Liver Transplantation for Locally Advanced Perihilar Cholangiocarcinoma (ACHIEVE-LT)","aka":["ACHIEVE-LT"],"tldr":"A phase 2 trial of the registered interventions with radiotherapy in gallbladder cancer and other biliary tract cancers, run by The First Affiliated Hospital with Nanjing Medical University, not yet recruiting.","summary":"A Prospective, Single-Arm, Phase II Study: PD-L1 Monoclonal Antibody + Chemoradiotherapy as Bridge Therapy to Liver Transplantation for Locally Advanced Perihilar Cholangiocarcinoma (ACHIEVE-LT) is a phase 2 interventional study registered as NCT07471165 by The First Affiliated Hospital with Nanjing Medical University, with a registry enrolment figure of 25 participants, started 2026-03-01 and due to reach its primary completion in 2029-03-01. Interventions recorded: PD -1/PD-L1 monoclonal antibody plus radiotherapy and liver transplantation. Conditions listed: Locally Advanced Perihilar Cholangiocarcinoma. Gallbladder cancer is named in the registry entry: \"Diagnosed with intrahepatic cholangiocarcinoma, distal cholangiocarcinoma, or gallbladder cancer.\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07471165","url":"https://clinicaltrials.gov/study/NCT07471165"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["chemoradiation","radiotherapy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07471165","phase":"2","setting":"A Prospective, Single-Arm, Phase II Study: PD-L1 Monoclonal Antibody + Chemoradiotherapy as Bridge Therapy to Liver Transplantation for Locally Advanced Perihilar Cholangiocarcinoma (ACHIEVE-LT)","sponsor":"The First Affiliated Hospital with Nanjing Medical University","started":"2026-03-01","startedType":"estimated","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07809256","kind":"trial","name":"A Prospective, Single-center, Non-randomized, Interventional Study on the Effectiveness and Safety of Combined Immunotargeted Therapy in Patients With Metastati","aka":["LPR-2"],"tldr":"A phase 3 trial in lung cancer, run by EuroCityClinic LLC, now recruiting.","summary":"A Prospective, Single-center, Non-randomized, Interventional Study on the Effectiveness and Safety of Combined Immunotargeted Therapy in Patients With Metastatic Non-small Cell Cancer With a RET Gene Translocation is a phase 3, interventional study registered as NCT07809256 by EuroCityClinic LLC, with a registry enrolment figure of 15 participants, started 2026-09 and due to reach its primary completion in 2028-08. Interventions recorded: lenvatinib pembrolizumab. Conditions listed: NSCLC (Non-small Cell Lung Cancer)R. Primary outcome: Progression-Free Survival (PFS); Objective Response Rate (ORR); Disease Control Rate (DCR). Lung eligibility wording from the registry: \"Have a confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC), established by examination of a tumor tissue sample, with cancer that has spread to distant parts of the body\". Sites: Russia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07809256","url":"https://clinicaltrials.gov/study/NCT07809256"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc","ret-fusion-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07809256","phase":"3","setting":"LPR-2: A Prospective, Single-center, Non-randomized, Interventional Study on the Effectiveness and Safety of Combined Immunotargeted Therapy in Patients With Metastatic Non-small Cell Cancer With a RET Gene Translocation","sponsor":"EuroCityClinic LLC","started":"2026-09","startedType":"estimated","enrolled":15,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07054242","kind":"trial","name":"A Prospective, Single-center, Phase II Study of Sacituzumab Tirumotecan in Combination With Pembrolizumab for Neoadjuvant Treatment of Triple-Negative Breast Ca","aka":[],"tldr":"A phase 2 trial of sacituzumab tirumotecan and pembrolizumab in triple-negative breast cancer, run by Yantai Yuhuangding Hospital, not yet recruiting.","summary":"A Prospective, Single-center, Phase II Study of Sacituzumab Tirumotecan in Combination With Pembrolizumab for Neoadjuvant Treatment of Triple-Negative Breast Cancer (TNBC) is a phase 2, interventional study registered as NCT07054242 by Yantai Yuhuangding Hospital, with a registry enrolment figure of 52 participants, started 2025-10-30 and due to reach its primary completion in 2026-10-30. Interventions recorded: Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab. Conditions listed: Neoadjuvant Therapy; Stage II to III (T1cN1-2 or T2-4N0-2) TNBC Breast Cancer. Triple-negative eligibility wording from the registry: \"Histologically or cytologically confirmed stage II-III (T1cN1-2 or T2-4N0-2) triple-negative breast cancer (TNBC), defined as:\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07054242","url":"https://clinicaltrials.gov/study/NCT07054242"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["sacituzumab-tirumotecan","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07054242","phase":"2","setting":"A Prospective, Single-center, Phase II Study of Sacituzumab Tirumotecan in Combination With Pembrolizumab for Neoadjuvant Treatment of Triple-Negative Breast Cancer (TNBC)","sponsor":"Yantai Yuhuangding Hospital","started":"2025-10-30","startedType":"estimated","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05085028","kind":"trial","name":"A Randomised Open-label Phase III Trial of REduced Frequency Pembrolizumab immuNothErapy for First-line Treatment of Patients With Advanced Non-small Cell Lung","aka":["REFINE-Lung"],"tldr":"A phase 3 trial in lung cancer, run by Imperial College London, now recruiting.","summary":"A Randomised Open-label Phase III Trial of REduced Frequency Pembrolizumab immuNothErapy for First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) is a phase 3, randomised interventional study registered as NCT05085028 by Imperial College London, with a registry enrolment figure of 1750 participants, started 2022-06-23 and due to reach its primary completion in 2027-05-31. Interventions recorded: Pembrolizumab 25 MG/ML [Keytruda]. Conditions listed: Lung Cancer, Nonsmall Cell. Primary outcome: Overall survival at 2 years. Lung eligibility wording from the registry: \"* Any patient ≥18yrs who has received 6 months of pembrolizumab treatment with or without chemotherapy for advanced Non small cell lung cancer who is planned to continue immunotherapy treatment because of continued benefit\". Sites: United Kingdom. United Kingdom sites listed: 37. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05085028","url":"https://clinicaltrials.gov/study/NCT05085028"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Royal Bournemouth Hospital (Bournemouth); Royal Sussex County Hospital (Brighton); Bristol Haematology and Oncology Centre (Bristol); Queen's Hospital (Burton-on-Trent); Cambridge University Hospitals NHS Foundation Trust (Cambridge); East Kent Hospitals University NHS Foundation Trust (Canterbury); Velindre Cancer Centre (Cardiff); Colchester Hospital (Colchester); Royal Derby Hospital (Derby); NHS Lothian (Edinburgh); Royal Devon and Exeter Hospital (Exeter); Beatson West of Scotland Cancer Centre (Glasgow) and 25 more."],"nct":"NCT05085028","phase":"3","setting":"A Randomised Open-label Phase III Trial of REduced Frequency Pembrolizumab immuNothErapy for First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Utilising a Novel Multi-arm Frequency-response Optimisation Design","sponsor":"Imperial College London","started":"2022-06-23","startedType":"actual","enrolled":1750,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06717126","kind":"trial","name":"A Randomised Phase II Study of Roginolisib in Patients With Advanced/Metastatic Uveal Melanoma","aka":["OCULE-01"],"tldr":"A phase 2 trial of Roginolisib in uveal melanoma, run by iOnctura, active and no longer recruiting.","summary":"A Randomised Phase II Study of Roginolisib in Patients With Advanced/Metastatic Uveal Melanoma is a phase 2 interventional study registered as NCT06717126 by iOnctura, with 85 participants enrolled, started 2025-02-27 and due to reach its primary completion in 2027-12. Interventions recorded: roginolisib and Investigator choice of standard therapy.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06717126","url":"https://clinicaltrials.gov/study/NCT06717126"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["uveal-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["roginolisib"],"companies":["ionctura"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06717126","phase":"2","setting":"A Phase II, Multi-centre, Open Label, Randomised Study to Evaluate the Anti-tumour Activity of Roginolisib in Patients With Advanced/Metastatic Ocular/Uveal Melanoma","sponsor":"iOnctura","started":"2025-02-27","startedType":"actual","enrolled":85,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07207070","kind":"trial","name":"A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial testing JS105 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer is a phase 3 interventional study registered as NCT07207070, led by Risen (Suzhou) Pharma Tech, and recruiting on the registry. Official title: A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer. Planned enrolment is 312 participants (estimated). The study started in 2025-11-12 and primary completion is expected in 2029-05-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07207070","url":"https://clinicaltrials.gov/study/NCT07207070"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":[],"targets":[],"drugs":["js105"],"companies":["junshi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07207070","phase":"3","setting":"A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer","sponsor":"Risen (Suzhou) Pharma Tech","started":"2025-11-12","startedType":"actual","enrolled":312,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03168880","kind":"trial","name":"A Randomized Controlled Trial of Neoadjuvant Weekly Paclitaxel Versus Weekly Paclitaxel Plus Weekly Carboplatin In Women With Large Operable or Locally Advanced","aka":["TNBC"],"tldr":"A phase 3 trial of paclitaxel / nab-paclitaxel and carboplatin in triple-negative breast cancer, run by Tata Memorial Hospital, active but no longer recruiting.","summary":"A Randomized Controlled Trial of Neoadjuvant Weekly Paclitaxel Versus Weekly Paclitaxel Plus Weekly Carboplatin In Women With Large Operable or Locally Advanced, Triple Negative Breast Cancer is a phase 3, randomised interventional study registered as NCT03168880 by Tata Memorial Hospital, with a registry enrolment figure of 720 participants, started 2010-04 and due to reach its primary completion in 2025-11-30. Interventions recorded: Paclitaxel + Carboplatin; Paclitaxel only. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"All patients with baseline clinical staging T4, N0-3, M0 or T1-4, N2-3, M0 and T3, N1, M0 with triple negative hormone status\". Sites: India. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03168880","url":"https://clinicaltrials.gov/study/NCT03168880"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["paclitaxel","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03168880","phase":"3","setting":"A Randomized Controlled Trial of Neoadjuvant Weekly Paclitaxel Versus Weekly Paclitaxel Plus Weekly Carboplatin In Women With Large Operable or Locally Advanced, Triple Negative Breast Cancer","sponsor":"Tata Memorial Hospital","started":"2010-04","enrolled":720,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07562490","kind":"trial","name":"A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decision-Making in High-Risk Stage III (T4N+ or T1-3N2) Colorectal Cancer","aka":["CLEAR-04"],"tldr":"A phase 2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Fudan University, now recruiting.","summary":"A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decision-Making in High-Risk Stage III (T4N+ or T1-3N2) Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07562490 by Fudan University, with a registry enrolment figure of 100 participants, started 2025-04-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: FOLFOX; Folfox plus Bevacizumab. Conditions listed: ctDNA; Chemotherapy; Colorectal Cancer. Primary outcome: Patient's 2-year Progression-Free Survival. Colorectal eligibility wording from the registry: \"Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07562490","url":"https://clinicaltrials.gov/study/NCT07562490"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","mrd-testing","platinum"],"targets":[],"drugs":["folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07562490","phase":"2","setting":"A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decision-Making in High-Risk Stage III (T4N+ or T1-3N2) Colorectal Cancer","sponsor":"Fudan University","started":"2025-04-01","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06992258","kind":"trial","name":"A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer","aka":["FRUITION"],"tldr":"A phase 2 trial of Fruquintinib, Trifluridine/tipiracil in colorectal cancer, run by Criterium, Inc., now recruiting.","summary":"A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer is a phase 2 interventional study registered as NCT06992258 by Criterium, Inc., with 120 participants planned, started 2025-10-27 and due to reach its primary completion in 2027-12-31. Interventions recorded: Fruquintinib+ Lonsurf (trifluridine and tipiracil), Fruquintinib. Conditions listed: Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06992258","url":"https://clinicaltrials.gov/study/NCT06992258"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib","trifluridine-tipiracil"],"companies":["criterium"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06992258","phase":"2","setting":"A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer","sponsor":"Criterium, Inc.","started":"2025-10-27","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04188145","kind":"trial","name":"A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Meta","aka":["BEVAMAINT"],"tldr":"A phase 3 trial of bevacizumab (glioblastoma use) in colorectal cancer, run by Centre Hospitalier Universitaire Dijon, active but no longer recruiting.","summary":"A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT04188145 by Centre Hospitalier Universitaire Dijon, with a registry enrolment figure of 400 participants, started 2020-01-27 and due to reach its primary completion in 2029-09. Interventions recorded: Fluoropyrimidine; Bevacizumab. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: The Time-to-Treatment Failure (TTF). Colorectal eligibility wording from the registry: \"* Histologically confirmed metastatic colorectal adenocarcinoma before induction treatment\". Sites: France. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04188145","url":"https://clinicaltrials.gov/study/NCT04188145"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04188145","phase":"3","setting":"A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Metastatic Colorectal Cancer","sponsor":"Centre Hospitalier Universitaire Dijon","started":"2020-01-27","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07101614","kind":"trial","name":"A Randomized Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy fo","aka":[],"tldr":"A phase 2 trial of toripalimab in triple-negative breast cancer, run by Shengjing Hospital, not yet recruiting.","summary":"A Randomized Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC). is a phase 2, randomised interventional study registered as NCT07101614 by Shengjing Hospital, with a registry enrolment figure of 125 participants, started 2025-09-01 and due to reach its primary completion in 2027-11-30. Interventions recorded: JS004 in combination with toripalimab and chemotherapy; Toripalimab and chemotherapy; Chemotherapy. Conditions listed: TNBC - Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"In cases of multiple pathological results, the definition of triple-negative breast cancer is based on the final molecular subtype result from the last biopsy pathology\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07101614","url":"https://clinicaltrials.gov/study/NCT07101614"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07101614","phase":"2","setting":"An Open-label, Randomized, Multi-center, Multi-cohort Clinical Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC).","sponsor":"Shengjing Hospital","started":"2025-09-01","startedType":"estimated","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06776952","kind":"trial","name":"A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma","aka":[],"tldr":"A phase 3 trial of Tucidinostat (chidamide) and XNW5004 in peripheral T-cell lymphomas, run by Evopoint Biosciences Inc., now recruiting.","summary":"A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma is a phase 3 interventional study registered as NCT06776952 by Evopoint Biosciences Inc., with 120 participants planned, started 2025-04-10 and due to reach its primary completion in 2028-01. Interventions recorded: XNW5004 ; Chidamide placebo and XNW5004 placebo; Chidamide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06776952","url":"https://clinicaltrials.gov/study/NCT06776952"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["tucidinostat","xnw5004"],"companies":["evopoint-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06776952","phase":"3","setting":"A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma","sponsor":"Evopoint Biosciences Inc.","started":"2025-04-10","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07669454","kind":"trial","name":"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300mg Capsule in Reducing Cancer-Tumor in Patients With Metastatic Colorectal Cancer Receiving Standard Chemotherapy.","aka":[],"tldr":"A phase 3 trial of Nuvastatic 300 in colorectal cancer, run by Natureceuticals Sdn Bhd, now recruiting.","summary":"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300mg Capsule in Reducing Cancer-Tumor in Patients With Metastatic Colorectal Cancer Receiving Standard Chemotherapy. is a phase 3 interventional study registered as NCT07669454 by Natureceuticals Sdn Bhd, with 250 participants planned, started 2025-10-01 and due to reach its primary completion in 2026-10-31. Interventions recorded: Nuvastatic 300 and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07669454","url":"https://clinicaltrials.gov/study/NCT07669454"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["natureceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07669454","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300mg Capsule in Reducing Cancer-Tumor in Patients With Metastatic Colorectal Cancer Receiving Standard Chemotherapy.","sponsor":"Natureceuticals Sdn Bhd","started":"2025-10-01","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06581406","kind":"trial","name":"A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult P","aka":[],"tldr":"A phase 2/3 trial of Ipilimumab, Nivolumab in melanoma and uveal melanoma, run by Replimune, Inc., now recruiting.","summary":"A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma is a phase 2/3 interventional study registered as NCT06581406 by Replimune, Inc., with 280 participants planned, started 2024-12-17 and due to reach its primary completion in 2030-01. Interventions recorded: RP2, Ipilimumab, Nivolumab. Conditions listed: Metastatic Uveal Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06581406","url":"https://clinicaltrials.gov/study/NCT06581406"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","uveal-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ipilimumab","nivolumab"],"companies":["replimune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06581406","phase":"2/3","setting":"A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab Versus Ipilimumab in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma","sponsor":"Replimune, Inc.","started":"2024-12-17","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07099794","kind":"trial","name":"A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen","aka":[],"tldr":"A phase 2 trial of fluorouracil, liposomal irinotecan and lenvatinib in gallbladder cancer and other biliary tract cancers, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, not yet recruiting.","summary":"A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen is a phase 2, randomised interventional study registered as NCT07099794 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 90 participants, started 2025-08-01 and due to reach its primary completion in 2029-02-28. Interventions recorded: Liposomal irinotecan+5-FU/LV+Lenvatinib, NALIRI. Conditions listed: Biliary Tract Cancer (BTC). Gallbladder cancer is named in the registry entry: \"* Histologically or cell line confirmed advanced biliary system malignancies, including intrahepatic, extrahepatic, and gallbladder cancers;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07099794","url":"https://clinicaltrials.gov/study/NCT07099794"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["fluorouracil","liposomal-irinotecan","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07099794","phase":"2","setting":"Liposomal Irinotecan (II) and Fluorouracil and Calcium Folinate in Combination With or Without Renvastinib for Second-line Treatment of Advanced Biliary System Tumors: a Randomized, Two-cohort, Prospective Phase II Study","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2025-08-01","startedType":"estimated","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07172919","kind":"trial","name":"A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation","aka":[],"tldr":"A phase 2 trial of Sotorasib and Panitumumab in advanced solid tumours, run by Amgen, now recruiting.","summary":"A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation is a phase 2 interventional study registered as NCT07172919 by Amgen, with 14 participants planned, started 2026-01-02 and due to reach its primary completion in 2028-07-01. Interventions recorded: Sotorasib and Panitumumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07172919","url":"https://clinicaltrials.gov/study/NCT07172919"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kras-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["sotorasib","panitumumab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07172919","phase":"2","setting":"A Rollover Study of Sotorasib With or Without Panitumumab for the Treatment of Cancer Subjects With KRAS p.G12C Mutation Previously Treated in an Amgen-Sponsored Study","sponsor":"Amgen","started":"2026-01-02","startedType":"actual","enrolled":14,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05862285","kind":"trial","name":"A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study","aka":["UmbrellaMAX"],"tldr":"A phase 3 trial testing Ipatasertib, now recruiting.","summary":"A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study is a phase 3 interventional study registered as NCT05862285, led by Hoffmann-La Roche, and recruiting on the registry. Official title: An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study. Planned enrolment is 100 participants (estimated). The study started in 2023-06-01 and primary completion is expected in 2033-03-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05862285","url":"https://clinicaltrials.gov/study/NCT05862285"}],"tags":["ctgov-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":["ipatasertib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05862285","phase":"3","setting":"An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study","sponsor":"Hoffmann-La Roche","started":"2023-06-01","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07569042","kind":"trial","name":"A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma","aka":[],"tldr":"A phase 1/2 trial of Temozolomide in advanced solid tumours, run by Novelwise Pharmaceutical Corporation, now recruiting.","summary":"A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma is a phase 1/2 interventional study registered as NCT07569042 by Novelwise Pharmaceutical Corporation, with 15 participants planned, started 2026-04-20 and due to reach its primary completion in 2029-09-30. Interventions recorded: NBM-BMX Capsule and Temozolomide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07569042","url":"https://clinicaltrials.gov/study/NCT07569042"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07569042","phase":"1/2","setting":"A Rollover Study to Evaluate the Long-Term Safety and Efficacy of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma Who Completed Study NBM-BMX-003 (the Parent Study)","sponsor":"Novelwise Pharmaceutical Corporation","started":"2026-04-20","startedType":"actual","enrolled":15,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02320435","kind":"trial","name":"A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial","aka":[],"tldr":"A phase 3 trial of Pertuzumab and Trastuzumab in advanced solid tumours, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial is a phase 3 interventional study registered as NCT02320435 by Hoffmann-La Roche, with 154 participants enrolled, started 2015-02-02 and due to reach its primary completion in 2026-12-31. Interventions recorded: Pertuzumab, Trastuzumab and Other Combination Anti-Cancer Therapies.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02320435","url":"https://clinicaltrials.gov/study/NCT02320435"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["pertuzumab","trastuzumab"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02320435","phase":"3","setting":"A Single-Arm Open-Label Multi-Centre Extension Study of Pertuzumab Administered As a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Study","sponsor":"Hoffmann-La Roche","started":"2015-02-02","startedType":"actual","enrolled":154,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05643742","kind":"trial","name":"A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies","aka":[],"tldr":"A phase 1/2 trial of CTX112 in hodgkin lymphoma and non-hodgkin lymphoma, run by CRISPR Therapeutics AG, now recruiting.","summary":"A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies is a phase 1/2 interventional study registered as NCT05643742 by CRISPR Therapeutics AG, with 120 participants planned, started 2023-03-10 and due to reach its primary completion in 2030-01. Interventions recorded: CTX112. Conditions listed: B-cell Lymphoma, Non-Hodgkin Lymphoma, B-cell Malignancy, Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05643742","url":"https://clinicaltrials.gov/study/NCT05643742"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma","follicular-lymphoma","mantle-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["ctx112"],"companies":["crispr-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05643742","phase":"1/2","setting":"A Phase 1/2, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Subjects With Relapsed or Refractory B Cell Malignancies","sponsor":"CRISPR Therapeutics AG","started":"2023-03-10","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06150885","kind":"trial","name":"A Safety And Efficacy Study Of Allogeneic CAR Gamma-Delta T Cells in Subjects With Relapsed/Refractory Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of HLA-G-CAR.BiTE allogeneic γδ T cells in advanced solid tumours, run by Ever Supreme Bio Technology Co., Ltd., now recruiting.","summary":"A Safety And Efficacy Study Of Allogeneic CAR Gamma-Delta T Cells in Subjects With Relapsed/Refractory Solid Tumors is a phase 1/2 interventional study registered as NCT06150885 by Ever Supreme Bio Technology Co., Ltd., with 60 participants planned, started 2024-09-01 and due to reach its primary completion in 2027-06-30. Interventions recorded: HLA-G-CAR.BiTE allogeneic γδ T cells.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06150885","url":"https://clinicaltrials.gov/study/NCT06150885"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06150885","phase":"1/2","setting":"A Single Arm, Open Label, Dose-escalation Phase I and Dose-expansion Phase IIa Clinical Study to Evaluate the Feasibility, Safety, and Efficacy of Allogeneic Chimeric Antigen Receptor (CAR) Gamma-Delta T Cells CAR001 in Subjects With Relapsed/Refractory Solid Tumors","sponsor":"Ever Supreme Bio Technology Co., Ltd.","started":"2024-09-01","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05654454","kind":"trial","name":"A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of Bevacizumab, Paclitaxel / nab-paclitaxel, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Mabscale, LLC, now recruiting.","summary":"A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT05654454 by Mabscale, LLC, with 620 participants planned, started 2023-05-31 and due to reach its primary completion in 2026-12. Interventions recorded: Bevacizumab, Paclitaxel, Carboplatin. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05654454","url":"https://clinicaltrials.gov/study/NCT05654454"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["bevacizumab","paclitaxel","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05654454","phase":"3","setting":"Randomized Double Blind Phase III Trial Comparing Safety and Efficacy of Bevacizumab (Mabscale LLC, Russia) + Paclitaxel + Carboplatin to Avastin® + Paclitaxel + Carboplatin in Inoperable or Advanced Non-squamous Non-small-cell Lung Cancer","sponsor":"Mabscale, LLC","started":"2023-05-31","startedType":"actual","enrolled":620,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07365319","kind":"trial","name":"A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer","aka":["TeLuRide-008"],"tldr":"A phase 2/3 trial testing EIK1001 in non-small-cell lung cancer, now recruiting.","summary":"A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer is a phase 2/3 interventional study registered as NCT07365319, led by Eikon Therapeutics with Merck Sharp & Dohme, and recruiting on the registry. Official title: A Global, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008). Planned enrolment is 750 participants (estimated). The study started in 2026-06-15 and primary completion is expected in 2035-12-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07365319","url":"https://clinicaltrials.gov/study/NCT07365319"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["eik1001"],"companies":["eikon-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07365319","phase":"2/3","setting":"A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008)","sponsor":"Eikon Therapeutics","started":"2026-06-15","startedType":"actual","enrolled":750,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01890746","kind":"trial","name":"A Safety and Efficacy Study of Eltrombopag in Subjects With AML","aka":[],"tldr":"A phase 2 trial of Daunorubicin, Cytarabine and Eltrombopag in Leukaemia, run by Novartis Pharmaceuticals, completed.","summary":"A Safety and Efficacy Study of Eltrombopag in Subjects With AML is a phase 2 interventional study registered as NCT01890746 by Novartis Pharmaceuticals, with 148 participants recorded, started 2013-09-05 and reaching its primary completion in 2015-03-13. Interventions recorded: Daunorubicin, Cytarabine, Eltrombopag, Placebo. Conditions recorded: Acute Leukaemia.\n\nLinked to the drug Eltrombopag because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01890746","url":"https://clinicaltrials.gov/study/NCT01890746"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["daunorubicin","cytarabine","eltrombopag"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01890746","phase":"2","setting":"A Randomized, Blinded, Placebo-Controlled, Dose Finding Study to Assess the Safety and Efficacy of the Oral Thrombopoietin Receptor Agonist, Eltrombopag, Administered to Subjects With Acute Myelogenous Leukaemia (AML) Receiving Induction Chemotherapy","sponsor":"Novartis Pharmaceuticals","started":"2013-09-05","startedType":"actual","yearReported":2016,"enrolled":148,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Liver Events.","primary":true,"unit":"participants","arms":[{"name":"Eltrombopag (ELQ) QD","n":74,"value":2,"note":"Figures from the ClinicalTrials.gov results section (first posted 2016-06-14), not from a publication"},{"name":"Placebo QD","n":71,"value":6}],"source":"https://clinicaltrials.gov/study/NCT01890746?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"participants","arms":[{"name":"Eltrombopag (ELQ) QD","n":74,"value":39,"note":"Figures from the ClinicalTrials.gov results section (first posted 2016-06-14), not from a publication"},{"name":"Placebo QD","n":74,"value":30}],"hr":1.54,"ci":[0.96,2.47],"p":"0.0688","source":"https://clinicaltrials.gov/study/NCT01890746?tab=results"}]},{"id":"nct05329766","kind":"trial","name":"A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies","aka":["EDGE-Gastric"],"tldr":"A phase 2 trial of Domvanalimab, Quemliclustat, Zimberelimab and Oxaliplatin in advanced solid tumours, run by Arcus Biosciences, Inc., active and no longer recruiting.","summary":"A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies is a phase 2 interventional study registered as NCT05329766 by Arcus Biosciences, Inc., with 332 participants enrolled, started 2022-06-10 and due to reach its primary completion in 2027-01. Interventions recorded: Domvanalimab, Quemliclustat, Zimberelimab, Fluorouracil, Leucovorin and Oxaliplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05329766","url":"https://clinicaltrials.gov/study/NCT05329766"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["domvanalimab","quemliclustat","zimberelimab","oxaliplatin"],"companies":["arcus-biosciences","gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05329766","phase":"2","setting":"A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)","sponsor":"Arcus Biosciences, Inc.","started":"2022-06-10","startedType":"actual","enrolled":332,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03790111","kind":"trial","name":"A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of Telotristat ethyl in Biliary tract cancer and Biliary tract cancer, run by TerSera Therapeutics LLC, recorded as terminated on the registry.","summary":"A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT03790111 by TerSera Therapeutics LLC, with 53 participants recorded, started 2019-03-13 and due to reach its primary completion in 2022-01-13. Interventions recorded: telotristat ethyl. Conditions recorded: Biliary Tract Cancer (BTC).\n\nLinked to the drug Telotristat ethyl because the registry names it among its interventions and Biliary tract cancer and Biliary tract cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03790111","url":"https://clinicaltrials.gov/study/NCT03790111"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["biliary-tract-cancer","cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["telotristat-ethyl"],"companies":["tersera-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03790111","phase":"2","setting":"A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO® (Telotristat Ethyl) Plus First-line Chemotherapy in Patients With Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC)","sponsor":"TerSera Therapeutics LLC","started":"2019-03-13","startedType":"actual","yearReported":2023,"enrolled":53,"enrolledBasis":"registry","outcomes":[{"endpoint":"Project Overall Survival Rate at Month 6","primary":true,"unit":"proportion of participants","arms":[{"name":"Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg","n":53,"value":0.87,"note":"95% CI 0.74 to 0.93; Figures from the ClinicalTrials.gov results section (first posted 2023-04-19), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03790111?tab=results"},{"endpoint":"Median Progression Free Survival","unit":"months","arms":[{"name":"Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg","n":53,"value":6.233,"note":"95% CI 4.067 to 7.467; Figures from the ClinicalTrials.gov results section (first posted 2023-04-19), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03790111?tab=results"},{"endpoint":"Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment","unit":"participants","arms":[{"name":"Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg","n":53,"value":7,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-04-19), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03790111?tab=results"}]},{"id":"nct03930953","kind":"trial","name":"A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory No","aka":[],"tldr":"A phase 1/2 trial of Golcadomide, Rituximab, Obinutuzumab in non-hodgkin lymphoma, run by Celgene, active and no longer recruiting.","summary":"A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL) is a phase 1/2 interventional study registered as NCT03930953 by Celgene, with 438 participants planned, started 2019-05-20 and due to reach its primary completion in 2027-04-07. Interventions recorded: CC-99282, Rituximab, Obinutuzumab, Tafasitamab, Valemetostat. Conditions listed: Lymphoma, Non-Hodgkin. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03930953","url":"https://clinicaltrials.gov/study/NCT03930953"}],"tags":["ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["golcadomide","rituximab","obinutuzumab","tafasitamab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03930953","phase":"1/2","setting":"A Phase 1/2, Multi-center, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL).","sponsor":"Celgene","started":"2019-05-20","startedType":"actual","enrolled":438,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00781612","kind":"trial","name":"A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies","aka":[],"tldr":"A phase 2 trial of Docetaxel, Pertuzumab, Trastuzumab, Trastuzumab emtansine and Atezolizumab in advanced solid tumours, run by Genentech, Inc., active and no longer recruiting.","summary":"A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies is a phase 2 interventional study registered as NCT00781612 by Genentech, Inc., with 378 participants enrolled, started 2008-10-16 and due to reach its primary completion in 2027-06-30. Interventions recorded: Docetaxel, Paclitaxel, Pertuzumab, Trastuzumab, Trastuzumab Emtansine and Atezolizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT00781612","url":"https://clinicaltrials.gov/study/NCT00781612"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc","monoclonal-antibody"],"targets":[],"drugs":["docetaxel","pertuzumab","trastuzumab","trastuzumab-emtansine","atezolizumab"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00781612","phase":"2","setting":"An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emtansine Study","sponsor":"Genentech, Inc.","started":"2008-10-16","startedType":"actual","enrolled":378,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05806099","kind":"trial","name":"A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL","aka":[],"tldr":"A phase 1/2 trial of MBS303 in non-Hodgkin lymphoma, run by Beijing Mabworks Biotech Co., Ltd., now recruiting.","summary":"A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL is a phase 1/2 interventional study registered as NCT05806099 by Beijing Mabworks Biotech Co., Ltd., with 132 participants planned, started 2023-06-28 and due to reach its primary completion in 2025-11. Interventions recorded: MBS303.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05806099","url":"https://clinicaltrials.gov/study/NCT05806099"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["beijing-mabworks-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05806099","phase":"1/2","setting":"A Phase I/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS303 in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma","sponsor":"Beijing Mabworks Biotech Co., Ltd.","started":"2023-06-28","startedType":"actual","enrolled":132,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06312982","kind":"trial","name":"A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2/3 trial of tislelizumab in colorectal cancer, run by Beijing Friendship Hospital, now recruiting.","summary":"A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer is a phase 2/3, randomised interventional study registered as NCT06312982 by Beijing Friendship Hospital, with a registry enrolment figure of 375 participants, started 2024-03-16 and due to reach its primary completion in 2026-12-01. Interventions recorded: Tislelizumab. Conditions listed: Locally Advanced Rectal Carcinoma. Primary outcome: CR. Colorectal eligibility wording from the registry: \"Pathohistologically confirmed rectal adenocarcinoma, along with immunohistochemical results of pMMR or genetic test results of MSS;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06312982","url":"https://clinicaltrials.gov/study/NCT06312982"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06312982","phase":"2/3","setting":"A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer: From a Multicenter Phase II Cohort to a Phase III Randomized Controlled Study","sponsor":"Beijing Friendship Hospital","started":"2024-03-16","startedType":"actual","enrolled":375,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00106431","kind":"trial","name":"A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)","aka":[],"tldr":"A phase 2 trial of Romidepsin in Cutaneous T-cell lymphoma, run by Celgene, completed.","summary":"A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL) is a phase 2 interventional study registered as NCT00106431 by Celgene, with 102 participants recorded, started 2005-01-01 and reaching its primary completion in 2008-06-01. Interventions recorded: romidepsin (depsipeptide, FK228). Conditions recorded: Cutaneous T-cell Lymphoma.\n\nLinked to the drug Romidepsin because the registry names it among its interventions and Cutaneous T-cell lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00106431","url":"https://clinicaltrials.gov/study/NCT00106431"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cutaneous-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["romidepsin"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00106431","phase":"2","setting":"A Single Agent Phase II Study of Depsipeptide (FK228) in the Treatment of Cutaneous T-cell Lymphoma","sponsor":"Celgene","started":"2005-01-01","startedType":"actual","yearReported":2010,"enrolled":102,"enrolledBasis":"registry","outcomes":[{"endpoint":"The Percent of Patients (Pts) With Objective Disease Response","primary":true,"unit":"%","arms":[{"name":"Romidepsin","n":96,"value":34,"note":"Figures from the ClinicalTrials.gov results section (first posted 2010-04-23), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00106431?tab=results"}]},{"id":"nct05246514","kind":"trial","name":"A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC","aka":["DESTINY-Lung05"],"tldr":"A phase 2 trial of Trastuzumab deruxtecan in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC is a phase 2 interventional study registered as NCT05246514 by AstraZeneca, with 72 participants enrolled, started 2022-07-13 and due to reach its primary completion in 2024-11-04. Interventions recorded: Trastuzumab deruxtecan. Conditions listed: HER2-mutant Non-Small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2024; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05246514","url":"https://clinicaltrials.gov/study/NCT05246514"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","her2-mutant-nsclc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05246514-clin-lung-cancer-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05246514","phase":"2","setting":"An Open-label, Single-arm, Phase 2 Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for Patients With HER2-mutant Metastatic NSCLC Who Have Disease Progression on or After at Least One-line of Treatment (DESTINY-Lung05)","sponsor":"AstraZeneca","started":"2022-07-13","startedType":"actual","yearReported":2024,"enrolled":72,"enrolledBasis":"registry","outcomes":[{"endpoint":"ICR-assessed ORR (Objective Response Rate)","primary":true,"unit":"%","arms":[{"name":"T-DXd Arm","n":72,"value":56.9,"note":"95% CI 44.7 to 68.6; Figures from the ClinicalTrials.gov results section (first posted 2024-12-04), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT05246514?tab=results"},{"endpoint":"OS (Overall Survival)","unit":"months","arms":[{"name":"T-DXd Arm","n":72,"value":21,"note":"95% CI 17.5 to NA; Figures from the ClinicalTrials.gov results section (first posted 2024-12-04), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT05246514?tab=results"},{"endpoint":"ICR-assessed CNS-PFS (Central Nervous System Progression-free Survival)","unit":"months","arms":[{"name":"T-DXd Arm","n":72,"value":15.5,"note":"95% CI 9.9 to NA; Figures from the ClinicalTrials.gov results section (first posted 2024-12-04), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT05246514?tab=results"}]},{"id":"nct05309421","kind":"trial","name":"A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma","aka":[],"tldr":"A phase 2 trial of Pembrolizumab in melanoma, run by Evaxion Biotech A/S, active and no longer recruiting.","summary":"A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma is a phase 2 interventional study registered as NCT05309421 by Evaxion Biotech A/S, with 17 participants enrolled, started 2022-09-19 and due to reach its primary completion in 2025-09-30. Interventions recorded: EVX-01, Pembrolizumab 25 MG/ML. Conditions listed: Melanoma Stage IV, Unresectable Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05309421","url":"https://clinicaltrials.gov/study/NCT05309421"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["evaxion"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05309421","phase":"2","setting":"An Open Label, Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Checkpoint Inhibitor Treatment naïve Adults With Unresectable or Metastatic Melanoma","sponsor":"Evaxion Biotech A/S","started":"2022-09-19","startedType":"actual","enrolled":17,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06822543","kind":"trial","name":"A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cance","aka":["TROPICAL-1"],"tldr":"A phase 2 trial of pembrolizumab, datopotamab deruxtecan and carboplatin in lung cancer, run by Latin American Cooperative Oncology Group, now recruiting.","summary":"A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer) is a phase 2, interventional study registered as NCT06822543 by Latin American Cooperative Oncology Group, with a registry enrolment figure of 46 participants, started 2025-09-12 and due to reach its primary completion in 2028-06-30. Interventions recorded: Pembrolizumab; Datopotamab deruxtecan; Carboplatin. Conditions listed: Lung Cancer; Non Small Cell Lung Cancer; Brain Metastases. Primary outcome: Confirmed Intracranial Objective Response Rate (iORR) as Measured by the RANO-BM Criteria. Lung eligibility wording from the registry: \"\\- Male/female participants who are at least 18 years of age on the day of signing informed consent with a histologically confirmed diagnosis of NSCLC will be enrolled in this study\". Sites: Brazil. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06822543","url":"https://clinicaltrials.gov/study/NCT06822543"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["adc","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pembrolizumab","datopotamab-deruxtecan","carboplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06822543","phase":"2","setting":"A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)","sponsor":"Latin American Cooperative Oncology Group","started":"2025-09-12","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06048315","kind":"trial","name":"A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations and Failed EGFR TKIs W","aka":[],"tldr":"A phase 3 trial of anlotinib and penpulimab in lung cancer, run by Degan Lu, not yet recruiting.","summary":"A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations and Failed EGFR TKIs With the Combination of Enrotinib and Paclitaxel Monoclonal Antibody is a phase 3, interventional study registered as NCT06048315 by Degan Lu, with a registry enrolment figure of 52 participants, started 2023-09 and due to reach its primary completion in 2026-06. Interventions recorded: Anlotinib; Penpulimab. Conditions listed: Lung Cancer; TKI Resistance; EGFR Sensitive Mutation; Anlotinib; Pianzumab. Primary outcome: Progress Free Survival. Lung eligibility wording from the registry: \"* According to the International Association for the Study of Lung Cancer and the Joint Committee on the American Classification of Cancer, 8th edition TNM staging of lung cancer, locally advanced or metastatic (IIIB, IIIC, IV) NSCLC patients who are confirmed by histology or cytology to be inoperab\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06048315","url":"https://clinicaltrials.gov/study/NCT06048315"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["anlotinib","penpulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06048315","phase":"3","setting":"A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell","sponsor":"Degan Lu","started":"2023-09","startedType":"estimated","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07268677","kind":"trial","name":"A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peri","aka":[],"tldr":"A phase 2 trial of sintilimab in colorectal cancer, run by Guoxiang Cai, not yet recruiting.","summary":"A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peritoneal Metastasis. is a phase 2, interventional study registered as NCT07268677 by Guoxiang Cai, with a registry enrolment figure of 30 participants, started 2025-12-01 and due to reach its primary completion in 2026-12-01. Interventions recorded: pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy. Conditions listed: Colorectal Cancer. Primary outcome: ORR. Colorectal eligibility wording from the registry: \"Radiologically (CT/MRI/PET-CT/FAPI-PET) or pathologically confirmed peritoneal metastasis from colorectal cancer;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07268677","url":"https://clinicaltrials.gov/study/NCT07268677"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07268677","phase":"2","setting":"A Single-arm Clinical Trial of Pirfenidone Plus Sintilimab Combined With Standard Neoadjuvant Chemotherapy for Patients With Colorectal Cancer Peritoneal Metastasis","sponsor":"Guoxiang Cai","started":"2025-12-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07527026","kind":"trial","name":"A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant Therapy in Locally Advanced Low pMMR/MSS","aka":[],"tldr":"A phase 2 trial of camrelizumab in colorectal cancer, run by Chinese PLA General Hospital, now recruiting.","summary":"A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant Therapy in Locally Advanced Low pMMR/MSS Rectal Cancer is a phase 2, interventional study registered as NCT07527026 by Chinese PLA General Hospital, with a registry enrolment figure of 44 participants, started 2026-02-01 and due to reach its primary completion in 2028-02-01. Interventions recorded: Camrelizumab. Conditions listed: Locally Advanced Rectal Cancer. Primary outcome: CR rate. Colorectal eligibility wording from the registry: \"Histologically confirmed T3-4 and/or N+ rectal adenocarcinoma (AJCC/UICC TNM staging, 8th edition);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07527026","url":"https://clinicaltrials.gov/study/NCT07527026"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["camrelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07527026","phase":"2","setting":"A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant Therapy in Locally Advanced Low pMMR/MSS Rectal Cancer","sponsor":"Chinese PLA General Hospital","started":"2026-02-01","startedType":"actual","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06423170","kind":"trial","name":"A Single-arm Phase II Clinical Study of the Efficacy and Safety of Camrelizumab Combined With GEMOX for Unresectable GBCs","aka":[],"tldr":"A phase 2 trial of camrelizumab, gemcitabine and oxaliplatin in gallbladder cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, now recruiting.","summary":"A Single-arm Phase II Clinical Study of the Efficacy and Safety of Camrelizumab Combined With GEMOX for Unresectable GBCs is a phase 2 interventional study registered as NCT06423170 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, with a registry enrolment figure of 37 participants, started 2023-06-01 and due to reach its primary completion in 2025-12-31. Interventions recorded: Camrelizumab plus GEMOX. Conditions listed: Unresectable Gallbladder Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06423170","url":"https://clinicaltrials.gov/study/NCT06423170"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["camrelizumab","gemcitabine","oxaliplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06423170","phase":"2","setting":"Camrelizumab Plus Gemcitabine and Oxaliplatin (GEMOX) in Patients for Unresectable Gallbladder Cancer: a Single-arm, Phase II Trial","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","started":"2023-06-01","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07321015","kind":"trial","name":"A Single-Arm Phase Ⅱ Study of Fluzoparib Maintenance in Platinum-sensitive Advanced Triple-Negative Breast Cance","aka":["Fzp-MA-TNBC"],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Tianjin Medical University Cancer Institute and Hospital, now recruiting.","summary":"A Single-Arm Phase Ⅱ Study of Fluzoparib Maintenance in Platinum-sensitive Advanced Triple-Negative Breast Cance is a phase 2, interventional study registered as NCT07321015 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 72 participants, started 2026-01-20 and due to reach its primary completion in 2027-11-30. Interventions recorded: Fluzoparib Monotherapy. Conditions listed: Platinum-sensitive; TNBC, Triple Negative Breast Cancer; BRCA1/2 Mutation or Not. Triple-negative eligibility wording from the registry: \"Histologically confirmed triple-negative breast cancer (TNBC; ER \\<1%, PR \\<1%, HER2-negative)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07321015","url":"https://clinicaltrials.gov/study/NCT07321015"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07321015","phase":"2","setting":"An Exploratory Single-Arm Study of Maintenance Fluzoparib in Platinum-Sensitive, Advanced Triple-Negative Breast Cancer Patients With BRCA1/2 Mutation or Wild-Type BRCA","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2026-01-20","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06906471","kind":"trial","name":"A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS","aka":[],"tldr":"A phase 1/2 trial of AS1986NS in prostate cancer, run by Antelope Surgical Solutions, Inc, now recruiting.","summary":"A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS is a phase 1/2 interventional study registered as NCT06906471 by Antelope Surgical Solutions, Inc, with 10 participants planned, started 2026-07-01 and due to reach its primary completion in 2026-10-30. Interventions recorded: AS1986NS.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06906471","url":"https://clinicaltrials.gov/study/NCT06906471"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":["psma"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06906471","phase":"1/2","setting":"A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS","sponsor":"Antelope Surgical Solutions, Inc","started":"2026-07-01","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07728955","kind":"trial","name":"A Single-arm, Exploratory Clinical Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Anlotinib and Etoposide as First-line Therapy for","aka":["SCLC"],"tldr":"A phase 3 trial of anlotinib and etoposide in lung cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, not yet recruiting.","summary":"A Single-arm, Exploratory Clinical Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Anlotinib and Etoposide as First-line Therapy for Elderly Patients With Small-cell Lung Cancer or Those Who Are Intolerant to Intensive Chemotherapy is a phase 3, interventional study registered as NCT07728955 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, with a registry enrolment figure of 64 participants, started 2026-08-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: benmelstobart in combination with anlotinib and etoposide. Conditions listed: Small Cell Lung Cancer ( SCLC ). Primary outcome: Progression-Free Survival (PFS). Lung eligibility wording from the registry: \"Intensive treatment is defined as first-line intensive therapy for metastatic small cell lung cancer, i\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07728955","url":"https://clinicaltrials.gov/study/NCT07728955"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","kinase-inhibitors","topoisomerase-inhibitors"],"targets":[],"drugs":["anlotinib","etoposide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07728955","phase":"3","setting":"A Single-arm, Exploratory Clinical Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Anlotinib and Etoposide as First-line Therapy for Elderly Patients With Small-cell Lung Cancer or Those Who Are Intolerant to Intensive Chemotherapy","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","started":"2026-08-01","startedType":"estimated","enrolled":64,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07622550","kind":"trial","name":"A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS/BRAF-mutated A","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Jiangsu Cancer Institute & Hospital, not yet recruiting.","summary":"A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS/BRAF-mutated Advanced Colorectal Cance is a phase 2, interventional study registered as NCT07622550 by Jiangsu Cancer Institute & Hospital, with a registry enrolment figure of 80 participants, started 2026-06-15 and due to reach its primary completion in 2027-12-15. Interventions recorded: Serplulimab+Fruquintinib+XELOX. Conditions listed: Metastatic Colorectal Cancer (CRC). Primary outcome: Investigator-assessed Progression-Free Survival（PFS）. Colorectal eligibility wording from the registry: \"* Diagnosis of advanced unresectable or metastatic colorectal cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07622550","url":"https://clinicaltrials.gov/study/NCT07622550"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07622550","phase":"2","setting":"A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS/BRAF-mutated Advanced Colorectal Cance","sponsor":"Jiangsu Cancer Institute & Hospital","started":"2026-06-15","startedType":"estimated","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05482971","kind":"trial","name":"A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET","aka":[],"tldr":"A phase 2 trial of Ropeginterferon alfa-2b in myeloproliferative neoplasms, run by PharmaEssentia, active and no longer recruiting.","summary":"A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET is a phase 2 interventional study registered as NCT05482971 by PharmaEssentia, with 91 participants enrolled, started 2022-09-29 and due to reach its primary completion in 2025-05-09. Interventions recorded: Ropeginterferon alfa-2b-njft (P1101).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05482971","url":"https://clinicaltrials.gov/study/NCT05482971"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","essential-thrombocythaemia"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["ropeginterferon-alfa-2b"],"companies":["pharmaessentia"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05482971","phase":"2","setting":"A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Essential Thrombocythemia","sponsor":"PharmaEssentia","started":"2022-09-29","startedType":"actual","enrolled":91,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07135544","kind":"trial","name":"A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of adebrelimab in gallbladder cancer and other biliary tract cancers, run by Yongjun Chen, now recruiting.","summary":"A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer is a phase 2 interventional study registered as NCT07135544 by Yongjun Chen, with a registry enrolment figure of 37 participants, started 2025-08-14 and due to reach its primary completion in 2027-06-30. Interventions recorded: Adebrelimab combined with the GC regimen and Apatinib. Conditions listed: Biliary Tract Cancer, Biliary Tract Cancer (CCA). Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07135544","url":"https://clinicaltrials.gov/study/NCT07135544"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07135544","phase":"2","setting":"A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer","sponsor":"Yongjun Chen","started":"2025-08-14","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06866977","kind":"trial","name":"A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Xiangya Hospital of Central South University, not yet recruiting.","summary":"A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Advanced Pancreatic Cancer is a phase 1/2, interventional study registered as NCT06866977 by Xiangya Hospital of Central South University, with a registry enrolment figure of 10 participants, started 2025-03-12 and due to reach its primary completion in 2025-10-31. Interventions recorded: Oncolytic virus VRT106; Chemotherapy. Conditions listed: Pancreatic Cancer. Primary outcome: Safety and tolerability. Pancreatic eligibility wording from the registry: \"* Have unresectable pancreatic cancer as determined by imaging or surgical exploration and locally advanced or metastatic pancreatic ductal adenocarcinoma (including adenosquamous carcinoma) as confirmed by histology or cytology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06866977","url":"https://clinicaltrials.gov/study/NCT06866977"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06866977","phase":"1/2","setting":"A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Advanced Pancreatic Cancer","sponsor":"Xiangya Hospital of Central South University","started":"2025-03-12","startedType":"estimated","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06758544","kind":"trial","name":"A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Guangdong Provincial People's Hospital, now recruiting.","summary":"A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Resectable Pancreatic Cancer is a phase 1/2, interventional study registered as NCT06758544 by Guangdong Provincial People's Hospital, with a registry enrolment figure of 18 participants, started 2025-03-17 and due to reach its primary completion in 2026-09-30. Interventions recorded: Oncolytic virus VRT106; Chemotherapy. Conditions listed: Pancreatic Cancer. Primary outcome: Safety and tolerability. Pancreatic eligibility wording from the registry: \"Have a clinical diagnosis of pancreatic cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06758544","url":"https://clinicaltrials.gov/study/NCT06758544"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06758544","phase":"1/2","setting":"A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Resectable Pancreatic Cancer","sponsor":"Guangdong Provincial People's Hospital","started":"2025-03-17","startedType":"actual","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07198321","kind":"trial","name":"A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study of GFH276 in Patients With RAS-Mutant Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by Genfleet Therapeutics (Shanghai) Inc., not yet recruiting.","summary":"A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study of GFH276 in Patients With RAS-Mutant Advanced Solid Tumors is a phase 1/2, interventional study registered as NCT07198321 by Genfleet Therapeutics (Shanghai) Inc., with a registry enrolment figure of 450 participants, started 2025-09-22 and due to reach its primary completion in 2027-09-22. Interventions recorded: GFH276. Conditions listed: Cancer; PDAC; CRC (Colorectal Cancer); NSCLC. Primary outcome: Phase Ia:The incidence and severity of AEs and SAEs; Phase Ia:The incidence of DLT events; Phase Ib:The incidence and severity of AEs and SAEs. Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07198321","url":"https://clinicaltrials.gov/study/NCT07198321"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07198321","phase":"1/2","setting":"A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study","sponsor":"Genfleet Therapeutics (Shanghai) Inc.","started":"2025-09-22","startedType":"estimated","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06812260","kind":"trial","name":"A Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of HLX10 + Chemotherapy in Patients With ES-SCLC","aka":[],"tldr":"A phase 2 trial of HLX10+chemo in small-cell lung cancer, run by Shanghai Henlius Biotech, active and no longer recruiting.","summary":"A Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of HLX10 + Chemotherapy in Patients With ES-SCLC is a phase 2 interventional study registered as NCT06812260 by Shanghai Henlius Biotech, with 26 participants enrolled, started 2025-06-24 and due to reach its primary completion in 2026-10-22. Interventions recorded: HLX10+chemo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06812260","url":"https://clinicaltrials.gov/study/NCT06812260"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06812260","phase":"2","setting":"A Single-arm, Open-label, Phase II Study to Evaluate Clinical Efficacy, Safety and Pharmacokinetics of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination With Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Japanese Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)","sponsor":"Shanghai Henlius Biotech","started":"2025-06-24","startedType":"actual","enrolled":26,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06654947","kind":"trial","name":"A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer.","aka":[],"tldr":"A phase 2 trial of toripalimab, gemcitabine, oxaliplatin and surufatinib in gallbladder cancer and other biliary tract cancers, run by Fujian Cancer Hospital, not yet recruiting.","summary":"A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer. is a phase 2 interventional study registered as NCT06654947 by Fujian Cancer Hospital, with a registry enrolment figure of 23 participants, started 2025-01 and due to reach its primary completion in 2026-12. Interventions recorded: Surufatinib+Toripalimab+GEMOX. Conditions listed: Biliary Tract Cancer. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06654947","url":"https://clinicaltrials.gov/study/NCT06654947"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","kinase-inhibitors"],"targets":[],"drugs":["toripalimab","gemcitabine","oxaliplatin","surufatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06654947","phase":"2","setting":"A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer.","sponsor":"Fujian Cancer Hospital","started":"2025-01","startedType":"estimated","enrolled":23,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07797244","kind":"trial","name":"A Single-Arm, Phase II Study of Retlirafusp Alfa in Combination With XELOX and Bevacizumab for the First-Line Treatment of Advanced RAS-Mutated Colorectal Cance","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Dai, Guanghai, not yet recruiting.","summary":"A Single-Arm, Phase II Study of Retlirafusp Alfa in Combination With XELOX and Bevacizumab for the First-Line Treatment of Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM) is a phase 2, interventional study registered as NCT07797244 by Dai, Guanghai, with a registry enrolment figure of 46 participants, started 2026-10-29 and due to reach its primary completion in 2029-04. Interventions recorded: Retlirafusp alfa+XELOX+Bevacizumab Treatment. Conditions listed: Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM). Primary outcome: Objective response rate (ORR). Colorectal eligibility wording from the registry: \"Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07797244","url":"https://clinicaltrials.gov/study/NCT07797244"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07797244","phase":"2","setting":"A Single-Arm, Phase II Study of Retlirafusp Alfa in Combination With XELOX and Bevacizumab for the First-Line Treatment of Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM)","sponsor":"Dai, Guanghai","started":"2026-10-29","startedType":"estimated","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07789210","kind":"trial","name":"A Single-Arm, Phase II, Multicenter Clinical Study of Neoadjuvant Encorafenib Plus Cetuximab N01 and mFOLFOX6 in Patients With Locally Advanced BRAF V600E-Mutan","aka":["NEORAF"],"tldr":"A phase 2 trial in colorectal cancer, run by Zhejiang University, now recruiting.","summary":"A Single-Arm, Phase II, Multicenter Clinical Study of Neoadjuvant Encorafenib Plus Cetuximab N01 and mFOLFOX6 in Patients With Locally Advanced BRAF V600E-Mutant Colorectal Cancer With or Without Resectable Metastases is a phase 2, interventional study registered as NCT07789210 by Zhejiang University, with a registry enrolment figure of 25 participants, started 2026-06-30 and due to reach its primary completion in 2029-12-31. Interventions recorded: Neoadjuvant therapy of encorafenib plus cetuximab N01 and mFOLFOX6. Conditions listed: Colorectal Cancer; BRAF V600E Mutation Positive; Encorafenib; Cetuximab N01. Primary outcome: 18-month disease-free survival rate. Colorectal eligibility wording from the registry: \"* Colorectal adenocarcinoma diagnosed by histopathology, preoperative staging: T4N0-2M0, T3N2M0, T0-4N0-2M1a (with metastatic lesions present, requiring MDT evaluation as resectable); PMMR/MSS, BRAF V600E mutation, and both NRAS and KRAS wild-type;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07789210","url":"https://clinicaltrials.gov/study/NCT07789210"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","braf-v600e-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07789210","phase":"2","setting":"Neoadjuvant Encorafenib, Cetuximab N01 and mFolfox6 for BRAF V600E Mutated/ pMMR Localized Colorectal Cancer With or Without Resectable Metastases: a Single Arm, Multi-center, Phase 2 Clinical Trial","sponsor":"Zhejiang University","started":"2026-06-30","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07229846","kind":"trial","name":"A Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Standard Chemotherapy as First-line Treatme","aka":[],"tldr":"A phase 2 trial of FOLFOXIRI, fOLFOX (5-FU, leucovorin, oxaliplatin), fOLFIRI (5-FU, leucovorin, irinotecan), capecitabine and other drugs in colorectal cancer, run by Yanqiao Zhang, not yet recruiting.","summary":"A Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Standard Chemotherapy as First-line Treatment for MSS/pMMR Metastatic Colorectal Cancer With BRAF V600E Mutation is a phase 2, interventional study registered as NCT07229846 by Yanqiao Zhang, with a registry enrolment figure of 30 participants, started 2026-02 and due to reach its primary completion in 2027-02. Interventions recorded: Aipalolitovorelizumab; XELOX + Bevacizumab; mFOLFOX + Bevacizumab; FOLFOXIRI + Bevacizumab; Oxaliplatin + Irinotecan + Capecitabine + Bevacizumab. Conditions listed: Colorectal Cancer. Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"Patients with histopathologically confirmed unresectable metastatic colorectal adenocarcinoma of MSS/pMMR type with known BRAF V600E mutation;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07229846","url":"https://clinicaltrials.gov/study/NCT07229846"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","braf-v600e-colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfoxiri","folfox","folfiri","capecitabine","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07229846","phase":"2","setting":"A Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Standard Chemotherapy as First-line Treatment for MSS/pMMR Metastatic Colorectal Cancer With BRAF V600E Mutation","sponsor":"Yanqiao Zhang","started":"2026-02","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07347951","kind":"trial","name":"A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal Cancer","aka":[],"tldr":"A phase 2 trial of bevacizumab (glioblastoma use) in colorectal cancer, run by First Affiliated Hospital of Wenzhou Medical University, now recruiting.","summary":"A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal Cancer is a phase 2, interventional study registered as NCT07347951 by First Affiliated Hospital of Wenzhou Medical University, with a registry enrolment figure of 30 participants, started 2025-12-01 and due to reach its primary completion in 2027-12-01. Interventions recorded: Short-course radiotherapy; CAPOX chemotherapy; Targeted therapy with bevacizumab; Serplulimab immunotherapy. Conditions listed: Locally Advanced Rectal Cancer (LARC). Primary outcome: Pathological complete response (pCR) rate. Colorectal eligibility wording from the registry: \"* Diagnosed via pelvic MRI and rectoscopy with a tumor located ≤10 cm from the anal verge, with a clinical stage of cT3-4N0/+M0, and lymph nodes confined within the mesorectum\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07347951","url":"https://clinicaltrials.gov/study/NCT07347951"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07347951","phase":"2","setting":"A Single-Center, Prospective, Phase II Clinical Study to Evaluate the Preliminary Efficacy and Safety of Short-Course Radiotherapy Followed by CAPOX Chemotherapy Combined With Serplulimab and Bevacizumab as Total Neoadjuvant Therapy for MSS-Type, Mid-Low Locally Advanced Rectal Cancer","sponsor":"First Affiliated Hospital of Wenzhou Medical University","started":"2025-12-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05969171","kind":"trial","name":"A Single-center, Prospective, Two Cohort Study of Surufatinib Combined With AG or AG in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Ca","aka":[],"tldr":"A phase 2 trial of gemcitabine + nab-paclitaxel in pancreatic cancer, run by Fudan University, now recruiting.","summary":"A Single-center, Prospective, Two Cohort Study of Surufatinib Combined With AG or AG in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT05969171 by Fudan University, with a registry enrolment figure of 65 participants, started 2023-12-05 and due to reach its primary completion in 2026-12-31. Interventions recorded: Surufatinib, gemcitabine, nab-paclitaxel; Nab-paclitaxel, gemcitabine. Conditions listed: Pancreatic Cancer Metastatic. Primary outcome: Progression-free survival. Pancreatic eligibility wording from the registry: \"Unresectable, locally advanced or metastatic pancreatic cancer confirmed by histopathology or cytology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05969171","url":"https://clinicaltrials.gov/study/NCT05969171"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05969171","phase":"2","setting":"A Single-center, Prospective, Two Cohort Study of Surufatinib Combined With Gemcitabine and Nab-paclitaxel or Gemcitabine Combined With Nab-paclitaxel in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer","sponsor":"Fudan University","started":"2023-12-05","startedType":"actual","enrolled":65,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07415031","kind":"trial","name":"A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies","aka":[],"tldr":"A phase 2 trial of Adagrasib, Pembrolizumab, Cetuximab, Pemetrexed, Docetaxel and Oxaliplatin in advanced solid tumours, run by Mirati Therapeutics Inc., now recruiting.","summary":"A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies is a phase 2 interventional study registered as NCT07415031 by Mirati Therapeutics Inc., with 170 participants planned, started 2026-05-06 and due to reach its primary completion in 2028-02-16. Interventions recorded: Adagrasib, Pembrolizumab, Cetuximab, Pemetrexed, Docetaxel and Irinotecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07415031","url":"https://clinicaltrials.gov/study/NCT07415031"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["adagrasib","pembrolizumab","cetuximab","pemetrexed","docetaxel","oxaliplatin"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07415031","phase":"2","setting":"Solid Tumor Study for Long Term Treatment of Cancer Patients Who Have Participated in BMS Parent Studies Investigating Adagrasib (BMS-986503)","sponsor":"Mirati Therapeutics Inc.","started":"2026-05-06","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06614192","kind":"trial","name":"A Study Assessing Adverse Events and Disease Activity of Intravenously (IV) Infused Telisotuzumab Adizutecan in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer","aka":["AndroMETa-CRC-064"],"tldr":"A phase 3 trial testing Telisotuzumab adizutecan in colorectal cancer, active and no longer recruiting.","summary":"A Study Assessing Adverse Events and Disease Activity of Intravenously (IV) Infused Telisotuzumab Adizutecan in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer is a phase 3 interventional study registered as NCT06614192, led by AbbVie, and active but no longer recruiting on the registry. Official title: AndroMETa-CRC-064: An Open-Label, Randomised Global Dose Optimization Study Comparing Two Doses of Telisotuzumab Adizutecan (ABBV-400) Monotherapy in Subjects With Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff. Planned enrolment is 74 participants (actual). The study started in 2024-11-08 and primary completion is expected in 2027-08. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06614192","url":"https://clinicaltrials.gov/study/NCT06614192"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["telisotuzumab-adizutecan"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06614192","phase":"3","setting":"AndroMETa-CRC-064: An Open-Label, Randomized Global Dose Optimization Study Comparing Two Doses of Telisotuzumab Adizutecan (ABBV-400) Monotherapy in Subjects With Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff","sponsor":"AbbVie","started":"2024-11-08","startedType":"actual","enrolled":74,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06228326","kind":"trial","name":"A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs","aka":["KYANITE-1"],"tldr":"A phase 1/2 trial of Pembrolizumab, Docetaxel in metastatic cancer, run by Krystal Biotech, Inc., now recruiting.","summary":"A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs is a phase 1/2 interventional study registered as NCT06228326 by Krystal Biotech, Inc., with 250 participants planned, started 2024-04-17 and due to reach its primary completion in 2027-02. Interventions recorded: KB707, Pembrolizumab (KEYTRUDA®), Chemotherapy, Docetaxel. Conditions listed: Lung Cancer, Non-small Cell, Lung Cancer Metastatic, Solid Tumor, Adult, Advanced Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06228326","url":"https://clinicaltrials.gov/study/NCT06228326"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","docetaxel"],"companies":["krystal-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06228326","phase":"1/2","setting":"KB707-02: A Phase 1/2 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs","sponsor":"Krystal Biotech, Inc.","started":"2024-04-17","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05970497","kind":"trial","name":"A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Relatlimab + nivolumab, Pembrolizumab in melanoma, run by Krystal Biotech, Inc., now recruiting.","summary":"A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05970497 by Krystal Biotech, Inc., with 240 participants planned, started 2023-10-31 and due to reach its primary completion in 2027-07. Interventions recorded: KB707, Opdualag, KEYTRUDA ®( Pembrolizumab). Conditions listed: Cancer, Melanoma Stage III, Melanoma Stage IV, Cutaneous Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05970497","url":"https://clinicaltrials.gov/study/NCT05970497"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["relatlimab-nivolumab","pembrolizumab"],"companies":["krystal-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05970497","phase":"1/2","setting":"A Phase 1/2, Open-Label, Multi-Center, Dose Escalation and Expansion Study of KB707 in Subjects With Locally Advanced or Metastatic Solid Tumor Malignancies","sponsor":"Krystal Biotech, Inc.","started":"2023-10-31","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06413706","kind":"trial","name":"A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy","aka":[],"tldr":"A phase 2 trial of Abemaciclib and Temozolomide in glioma & glioblastoma, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy is a phase 2 interventional study registered as NCT06413706 by Eli Lilly and Company, with 45 participants enrolled, started 2024-10-25 and due to reach its primary completion in 2027-02. Interventions recorded: Abemaciclib and Temozolomide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06413706","url":"https://clinicaltrials.gov/study/NCT06413706"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma","paediatric-high-grade-glioma"],"sections":[],"technologies":["cdk46-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["abemaciclib","temozolomide"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06413706","phase":"2","setting":"A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Temozolomide Compared to Temozolomide Monotherapy in Children and Young Adults With Newly Diagnosed High-Grade Glioma Following Radiotherapy","sponsor":"Eli Lilly and Company","started":"2024-10-25","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06413498","kind":"trial","name":"A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma","aka":[],"tldr":"A phase 3 trial of Anitocabtagene autoleucel, Cyclophosphamide, Fludarabine in multiple myeloma, run by Kite, A Gilead Company, active and no longer recruiting.","summary":"A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT06413498 by Kite, A Gilead Company, with 452 participants enrolled, started 2024-08-23 and due to reach its primary completion in 2028-07. Interventions recorded: Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06413498","url":"https://clinicaltrials.gov/study/NCT06413498"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["anitocabtagene-autoleucel","cyclophosphamide","fludarabine","pomalidomide","bortezomib","dexamethasone"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06413498","phase":"3","setting":"A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma","sponsor":"Kite, A Gilead Company","started":"2024-08-23","startedType":"actual","enrolled":452,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07391657","kind":"trial","name":"A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Rela","aka":["DURGA-4"],"tldr":"A phase 3 trial of Daratumumab, Carfilzomib, Dexamethasone in multiple myeloma, run by AstraZeneca, now recruiting.","summary":"A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4) is a phase 3 interventional study registered as NCT07391657 by AstraZeneca, with 508 participants planned, started 2026-02-23 and due to reach its primary completion in 2028-06-14. Interventions recorded: AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib. Conditions listed: Relapsed Refractory Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07391657","url":"https://clinicaltrials.gov/study/NCT07391657"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["daratumumab","carfilzomib","dexamethasone","bortezomib","pomalidomide"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07391657","phase":"3","setting":"A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CART) Therapy Directed Against BCMA and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma.","sponsor":"AstraZeneca","started":"2026-02-23","startedType":"actual","enrolled":508,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07502300","kind":"trial","name":"A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Pa","aka":[],"tldr":"A phase 3 trial of Izalontamab brengitecan, Tislelizumab, Carboplatin in small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer(PANKU-Lung07) is a phase 3 interventional study registered as NCT07502300 by Sichuan Baili Pharmaceutical Co., Ltd., with 562 participants planned, started 2026-06-15 and due to reach its primary completion in 2029-12. Interventions recorded: BL-B01D1, Tislelizumab, Carboplatin, Etoposide. Conditions listed: Extensive-stage Small-cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07502300","url":"https://clinicaltrials.gov/study/NCT07502300"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["izalontamab-brengitecan","tislelizumab","carboplatin","etoposide"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07502300","phase":"3","setting":"A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 for Injection Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-06-15","startedType":"actual","enrolled":562,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07640789","kind":"trial","name":"A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-s","aka":["PANKU-Lung08"],"tldr":"A phase 3 trial of Izalontamab brengitecan, Osimertinib in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08) is a phase 3 interventional study registered as NCT07640789 by Sichuan Baili Pharmaceutical Co., Ltd., with 418 participants planned, started 2026-08-28 and due to reach its primary completion in 2030-12. Interventions recorded: BL-B01D1, Osimertinib. Conditions listed: Non-small Cell Lung Cancer Stage III. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07640789","url":"https://clinicaltrials.gov/study/NCT07640789"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["izalontamab-brengitecan","osimertinib"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07640789","phase":"3","setting":"A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-08-28","startedType":"actual","enrolled":418,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07739199","kind":"trial","name":"A Study Comparing BL-B01D1 in Combination With PD-1/VEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1/VEGF Bispecific Antibody in First-line","aka":["PANKU-Lung05"],"tldr":"A phase 2/3 trial of izalontamab brengitecan, paclitaxel / nab-paclitaxel and carboplatin in lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., not yet recruiting.","summary":"A Study Comparing BL-B01D1 in Combination With PD-1/VEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1/VEGF Bispecific Antibody in First-line Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer(PANKU-Lung05) is a phase 2/3, randomised interventional study registered as NCT07739199 by Sichuan Baili Pharmaceutical Co., Ltd., with a registry enrolment figure of 200 participants, started 2026-08 and due to reach its primary completion in 2029-12. Interventions recorded: BL-B01D1; PD-1/VEGF bispecific antibody; Paclitaxel; Carboplatin. Conditions listed: Squamous Non-small-cell Lung Cancer. Primary outcome: Phase II: Investigator-assessed Objective Response Rate (ORR); Phase II: Investigator-assessed Progression-free Survival (PFS); Phase III: BICR-assessed Progression-free Survival (PFS). Lung eligibility wording from the registry: \"Patients with locally advanced or metastatic squamous non-small cell lung cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07739199","url":"https://clinicaltrials.gov/study/NCT07739199"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-squamous-cell-carcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["izalontamab-brengitecan","paclitaxel","carboplatin"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07739199","phase":"2/3","setting":"A Phase II/III Clinical Study Comparing BL-B01D1 in Combination With PD-1/VEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1/VEGF Bispecific Antibody in First-line Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer(PANKU-Lung05)","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-08","startedType":"estimated","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06857175","kind":"trial","name":"A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma(PANKU-Bladder01)","aka":["PANKU-Bladder01"],"tldr":"A phase 3 trial of Docetaxel in bladder & urothelial cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma(PANKU-Bladder01) is a phase 3 interventional study registered as NCT06857175 by Sichuan Baili Pharmaceutical Co., Ltd., with 508 participants planned, started 2025-03-25 and due to reach its primary completion in 2027-06. Interventions recorded: BL-B01D1 and Docetaxel or Paclitaxel.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06857175","url":"https://clinicaltrials.gov/study/NCT06857175"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06857175","phase":"3","setting":"A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma After Failure of PD-1/PD-L1 Monoclonal Antibody and Platinum-based Chemotherapy","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2025-03-25","startedType":"actual","enrolled":508,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07648914","kind":"trial","name":"A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)","aka":["PANKU-Breast03"],"tldr":"A phase 3 trial of Capecitabine in advanced solid tumours, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03) is a phase 3 interventional study registered as NCT07648914 by Sichuan Baili Pharmaceutical Co., Ltd., with 446 participants planned, started 2026-07-06 and due to reach its primary completion in 2028-12. Interventions recorded: BL-B01D1, Albumin-Bound Paclitaxel, Paclitaxel and Capecitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07648914","url":"https://clinicaltrials.gov/study/NCT07648914"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07648914","phase":"3","setting":"A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-07-06","startedType":"actual","enrolled":446,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06343948","kind":"trial","name":"A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer(PANKU-Breast01)","aka":["PANKU-Breast01"],"tldr":"A phase 3 trial of Eribulin, Vinorelbine, Gemcitabine and Capecitabine in advanced solid tumours, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer(PANKU-Breast01) is a phase 3 interventional study registered as NCT06343948 by Sichuan Baili Pharmaceutical Co., Ltd., with 383 participants enrolled, started 2024-04-24 and due to reach its primary completion in 2026-08. Interventions recorded: BL-B01D1, Eribulin, Vinorelbine, Gemcitabine and Capecitabine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06343948","url":"https://clinicaltrials.gov/study/NCT06343948"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["eribulin","vinorelbine","gemcitabine","capecitabine"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06343948","phase":"3","setting":"A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer After Failure of at Least One Prior Line of Chemotherapy","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-04-24","startedType":"actual","enrolled":383,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06382129","kind":"trial","name":"A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer(PANKU","aka":[],"tldr":"A phase 3 trial of Izalontamab brengitecan, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer(PANKU-Lung02) is a phase 3 interventional study registered as NCT06382129 by Sichuan Baili Pharmaceutical Co., Ltd., with 698 participants enrolled, started 2024-05-17 and due to reach its primary completion in 2026-12. Interventions recorded: BL-B01D1, Docetaxel. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06382129","url":"https://clinicaltrials.gov/study/NCT06382129"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["izalontamab-brengitecan","docetaxel"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06382129","phase":"3","setting":"A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer After Failure of Anti-PD-1/PD-L1 Monoclonal Antibodies and Platinum-based Chemotherapy","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-05-17","startedType":"actual","enrolled":698,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06118333","kind":"trial","name":"A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma(PANKU-NPC01)","aka":["PANKU-NPC01"],"tldr":"A phase 3 trial of Izalontamab brengitecan, Capecitabine, Gemcitabine in nasopharyngeal carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma(PANKU-NPC01) is a phase 3 interventional study registered as NCT06118333 by Sichuan Baili Pharmaceutical Co., Ltd., with 386 participants enrolled, started 2023-12-04 and due to reach its primary completion in 2026-11. Interventions recorded: BL-B01D1, capecitabine, gemcitabine, docetaxel. Conditions listed: Nasopharyngeal Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06118333","url":"https://clinicaltrials.gov/study/NCT06118333"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nasopharyngeal","recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["izalontamab-brengitecan","capecitabine","gemcitabine","docetaxel"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06118333","phase":"3","setting":"A Phase III Randomized Controlled Trial to Compare BL-B01D1 With Physician's Choice of Chemotherapy (Last Line) in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Previously Treated With PD-1/PD-L1 Monoclonal Antibody and at Least Two Lines of Chemotherapy (at Least One Line of Platinum-based Chemotherapy)","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-12-04","startedType":"actual","enrolled":386,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06382116","kind":"trial","name":"A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer(PANKU-Lung01)","aka":["PANKU-Lung01"],"tldr":"A phase 3 trial of Izalontamab brengitecan, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer(PANKU-Lung01) is a phase 3 interventional study registered as NCT06382116 by Sichuan Baili Pharmaceutical Co., Ltd., with 432 participants enrolled, started 2024-05-22 and due to reach its primary completion in 2026-08. Interventions recorded: BL-B01D1, Pemetrexed+Cisplatin or Carboplatin. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06382116","url":"https://clinicaltrials.gov/study/NCT06382116"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["izalontamab-brengitecan","pemetrexed"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06382116","phase":"3","setting":"A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Platinum Based Chemotherapy (First-line of Systemic Treatment) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After EGFR-TKI Failure","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-05-22","startedType":"actual","enrolled":432,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06994195","kind":"trial","name":"A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANK","aka":[],"tldr":"A phase 3 trial of Izalontamab brengitecan in ovarian cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01) is a phase 3 interventional study registered as NCT06994195 by Sichuan Baili Pharmaceutical Co., Ltd., with 450 participants planned, started 2025-08-04 and due to reach its primary completion in 2027-06. Interventions recorded: BL-B01D1, Liposomal doxorubicin, Paclitaxel or Topotecan. Conditions listed: Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06994195","url":"https://clinicaltrials.gov/study/NCT06994195"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["adc","bispecific-adc"],"targets":[],"drugs":["izalontamab-brengitecan"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06994195","phase":"3","setting":"A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2025-08-04","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06500026","kind":"trial","name":"A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer(PANKU-Lung03)","aka":["PANKU-Lung03"],"tldr":"A phase 3 trial of Izalontamab brengitecan, Topotecan in small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer(PANKU-Lung03) is a phase 3 interventional study registered as NCT06500026 by Sichuan Baili Pharmaceutical Co., Ltd., with 722 participants enrolled, started 2024-08-07 and due to reach its primary completion in 2026-12. Interventions recorded: BL-B01D1, Topotecan. Conditions listed: Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06500026","url":"https://clinicaltrials.gov/study/NCT06500026"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["izalontamab-brengitecan","topotecan"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06500026","phase":"3","setting":"A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer After Failure of Anti-PD-1/PD-L1 Monoclonal Antibodies and Platinum-based Chemotherapy","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-08-07","startedType":"actual","enrolled":722,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07582315","kind":"trial","name":"A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)","aka":["PANKU-BTC01"],"tldr":"A phase 3 trial of Oxaliplatin and Capecitabine in biliary tract cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01) is a phase 3 interventional study registered as NCT07582315 by Sichuan Baili Pharmaceutical Co., Ltd., with 538 participants planned, started 2026-06-29 and due to reach its primary completion in 2028-12. Interventions recorded: BL-B01D1, Oxaliplatin, Calcium levofolinate, Fluorouracil, Irinotecan Hydrochloride Liposome and Irinotecan Hydrochloride.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07582315","url":"https://clinicaltrials.gov/study/NCT07582315"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["oxaliplatin","capecitabine"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07582315","phase":"3","setting":"A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-06-29","startedType":"actual","enrolled":538,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07518147","kind":"trial","name":"A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment","aka":[],"tldr":"A phase 3 trial of Docetaxel in gastric & gastro-oesophageal junction cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment is a phase 3 interventional study registered as NCT07518147 by Sichuan Baili Pharmaceutical Co., Ltd., with 438 participants planned, started 2026-05-15 and due to reach its primary completion in 2029-12. Interventions recorded: BL-M05D1, Paclitaxel, Docetaxel and Irinotecan hydrochloride.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07518147","url":"https://clinicaltrials.gov/study/NCT07518147"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07518147","phase":"3","setting":"A Randomized Controlled Phase III Clinical Study Comparing BL-M05D1 for Injection With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN) 18.2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-line Treatment","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-05-15","startedType":"actual","enrolled":438,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07678957","kind":"trial","name":"A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer","aka":[],"tldr":"A phase 2 trial of BL-M07D1 in HER2-positive breast cancer and HR-positive / HER2-negative breast cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer is a phase 2 interventional study registered as NCT07678957 by Sichuan Baili Pharmaceutical Co., Ltd., with 120 participants planned, started 2026-08-31 and due to reach its primary completion in 2028-12. Interventions recorded: BL-M07D1 and DS-8201.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07678957","url":"https://clinicaltrials.gov/study/NCT07678957"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","breast-hr-positive","her2-low-metastatic-breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07678957","phase":"2","setting":"A Randomized Controlled Phase II Clinical Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-08-31","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07730489","kind":"trial","name":"A Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, F","aka":[],"tldr":"A phase 3 trial of trastuzumab brengitecan, regorafenib, fruquintinib and trifluridine/tipiracil in colorectal cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., not yet recruiting.","summary":"A Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, Fluorouracil and Irinotecan is a phase 3, randomised interventional study registered as NCT07730489 by Sichuan Baili Pharmaceutical Co., Ltd., with a registry enrolment figure of 130 participants, started 2026-08 and due to reach its primary completion in 2027-12. Interventions recorded: BL-M07D1; Regorafenib; Fruquintinib; TAS-102. Conditions listed: Colorectal Cancer. Primary outcome: BICR-assessed Progression-free Survival (PFS). Colorectal eligibility wording from the registry: \"Patients with histologically or cytologically confirmed metastatic colorectal cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07730489","url":"https://clinicaltrials.gov/study/NCT07730489"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","her2-amplified-colorectal"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["trastuzumab-brengitecan","regorafenib","fruquintinib","trifluridine-tipiracil"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07730489","phase":"3","setting":"A Phase III Randomized Controlled Clinical Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, Fluorouracil and Irinotecan","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-08","startedType":"estimated","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06316531","kind":"trial","name":"A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer","aka":[],"tldr":"A phase 3 trial of Trastuzumab brengitecan, Trastuzumab emtansine in her2-positive breast cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer is a phase 3 interventional study registered as NCT06316531 by Sichuan Baili Pharmaceutical Co., Ltd., with 274 participants enrolled, started 2024-05-08 and due to reach its primary completion in 2026-10. Interventions recorded: BL-M07D1, T-DM1. Conditions listed: HER2-positive Breast Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06316531","url":"https://clinicaltrials.gov/study/NCT06316531"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-brengitecan","trastuzumab-emtansine"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06316531","phase":"3","setting":"A Randomized Controlled Phase III Clinical Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-05-08","startedType":"actual","enrolled":274,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05186506","kind":"trial","name":"A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Sichuan University, not yet recruiting.","summary":"A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer is a phase 2, randomised interventional study registered as NCT05186506 by Sichuan University, with a registry enrolment figure of 152 participants, started 2022-01-01 and due to reach its primary completion in 2025-12-15. Interventions recorded: Ensatinib; chemotherapy. Conditions listed: ALK Fusion Protein Expression; Adjuvant Therapy; Non-Small Cell Lung Cancer. Primary outcome: Disease free survival (DFS). Lung eligibility wording from the registry: \"* Surgical resection of histologically confirmed Stage IIA to IIIA NSCLC with negative margins, ,within 10 weeks after the operation\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05186506","url":"https://clinicaltrials.gov/study/NCT05186506"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["alk-positive-nsclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["betta"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05186506","phase":"2","setting":"A Phase II, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer","sponsor":"Sichuan University","started":"2022-01-01","startedType":"estimated","enrolled":152,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07258511","kind":"trial","name":"A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma","aka":["TRIlogy-4"],"tldr":"A phase 3 trial testing JNJ-79635322 in multiple myeloma, now recruiting.","summary":"A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT07258511, led by Janssen Research & Development, and recruiting on the registry. Official title: A Phase 3 Randomised Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody. Planned enrolment is 400 participants (estimated). The study started in 2026-02-04 and primary completion is expected in 2028-12-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07258511","url":"https://clinicaltrials.gov/study/NCT07258511"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["jnj-79635322"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07258511","phase":"3","setting":"A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody","sponsor":"Janssen Research & Development","started":"2026-02-04","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07518186","kind":"trial","name":"A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma","aka":["TRIlogy-5"],"tldr":"A phase 3 trial testing JNJ-79635322 in multiple myeloma, now recruiting.","summary":"A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT07518186, led by Janssen Research & Development, and recruiting on the registry. Official title: A Phase 3 Randomised Study Comparing JNJ-79635322 Versus Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma After 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide. Planned enrolment is 700 participants (estimated). The study started in 2026-05-31 and primary completion is expected in 2029-04-29. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07518186","url":"https://clinicaltrials.gov/study/NCT07518186"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["jnj-79635322"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07518186","phase":"3","setting":"A Phase 3 Randomized Study Comparing JNJ-79635322 Versus Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma After 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide","sponsor":"Janssen Research & Development","started":"2026-05-31","startedType":"actual","enrolled":700,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07138846","kind":"trial","name":"A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial in pancreatic cancer, run by Lepu Biopharma Co., Ltd., not yet recruiting.","summary":"A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer is a phase 3, randomised interventional study registered as NCT07138846 by Lepu Biopharma Co., Ltd., with a registry enrolment figure of 231 participants, started 2027-01 and due to reach its primary completion in 2027-06. Interventions recorded: MRG004A plus best supportive care; Placebo plus best supportive care. Conditions listed: Advanced Pancreatic Cancer. Primary outcome: Overall Survival (OS). Pancreatic eligibility wording from the registry: \"* Patients with histologically and cytologically confirmed locally advanced or metastatic pancreatic cancer, including adenocarcinoma, who have failed at least prior systemic therapies including gemcitabine and fluorouracil\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07138846","url":"https://clinicaltrials.gov/study/NCT07138846"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["lepu-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07138846","phase":"3","setting":"A Randomized, Double-blind, Multi-center, Phase III Study of MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer","sponsor":"Lepu Biopharma Co., Ltd.","started":"2027-01","startedType":"estimated","enrolled":231,"enrolledBasis":"registry","outcomes":[]},{"id":"mountaintap-30","kind":"trial","name":"A Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion (MountainTAP-30)","aka":["MountainTAP-30"],"tldr":"A phase 2/3 trial testing Navlimetostat in pancreatic ductal adenocarcinoma, active and no longer recruiting.","summary":"A Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion (MountainTAP-30) is a phase 2/3 interventional study registered as NCT07076121, led by Bristol-Myers Squibb, and active but no longer recruiting on the registry. Official title: A Randomised, Phase 2/3 Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma Harboring Homozygous MTAP Deletion. Planned enrolment is 470 participants (estimated). The study started in 2025-10-23 and primary completion is expected in 2029-05-03. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07076121","url":"https://clinicaltrials.gov/study/NCT07076121"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["navlimetostat"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07076121","phase":"2/3","setting":"A Randomized, Phase 2/3 Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma Harboring Homozygous MTAP Deletion","sponsor":"Bristol-Myers Squibb","started":"2025-10-23","startedType":"actual","enrolled":470,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07802821","kind":"trial","name":"A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Sm","aka":[],"tldr":"A phase 3 trial of QLC5508, QL2107, tislelizumab, carboplatin and other drugs in lung cancer, run by Qilu Pharmaceutical Co., Ltd., not yet recruiting.","summary":"A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT07802821 by Qilu Pharmaceutical Co., Ltd., with a registry enrolment figure of 556 participants, started 2026-10-15 and due to reach its primary completion in 2029-03-15. Interventions recorded: QLC5508; QL2107; Tislelizumab; Carboplatin; Cisplatin; Etoposide. Conditions listed: Extensive-stage Small Cell Lung Cancer. Primary outcome: Overall survival (OS). Lung eligibility wording from the registry: \"Participants with histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the Veterans Administration Lung Cancer Study Group (VALG) staging system\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07802821","url":"https://clinicaltrials.gov/study/NCT07802821"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["qlc5508","ql2107","tislelizumab","carboplatin","cisplatin","etoposide"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07802821","phase":"3","setting":"A Phase III, Randomized, Controlled, Open-label Clinical Study to Compare the Efficacy and Safety of QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy as First-line Treatment in Participants With Extensive-stage Small Cell Lung Cancer","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2026-10-15","startedType":"estimated","enrolled":556,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07138209","kind":"trial","name":"A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 3 trial testing QLS32015 in multiple myeloma, now recruiting.","summary":"A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT07138209, led by Qilu Pharmaceutical, and recruiting on the registry. Official title: A Phase 3 Randomised Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma. Planned enrolment is 228 participants (estimated). The study started in 2025-11-07 and primary completion is expected in 2027-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07138209","url":"https://clinicaltrials.gov/study/NCT07138209"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["qls32015"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07138209","phase":"3","setting":"A Phase 3 Randomized Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma","sponsor":"Qilu Pharmaceutical","started":"2025-11-07","startedType":"actual","enrolled":228,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04606771","kind":"trial","name":"A Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC","aka":[],"tldr":"A phase 2 trial of Osimertinib, Savolitinib in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC is a phase 2 interventional study registered as NCT04606771 by AstraZeneca, with 30 participants enrolled, started 2020-09-28 and due to reach its primary completion in 2022-12-21. Interventions recorded: Osimertinib + Savolitinib, Savolitinib + Placebo. Conditions listed: Non-Small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2024; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04606771","url":"https://clinicaltrials.gov/study/NCT04606771"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib","savolitinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04606771","phase":"2","setting":"A Multi-centre Phase II, Double-Blind, Randomised Study of Savolitinib in Combination With Osimertinib vs Savolitinib in Combination With Placebo in Patients With EGFRm+ and MET Amplified Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed Following Treatment With Osimertinib","sponsor":"AstraZeneca","started":"2020-09-28","startedType":"actual","yearReported":2024,"enrolled":30,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Savolitinib Plus Osimertinib","n":14,"value":57.1,"note":"95% CI 28.86 to 82.34; Figures from the ClinicalTrials.gov results section (first posted 2024-09-24), not from a publication"},{"name":"Savolitinib Plus Placebo","n":16,"value":12.5,"note":"95% CI 1.55 to 38.35"}],"source":"https://clinicaltrials.gov/study/NCT04606771?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Savolitinib Plus Osimertinib","n":14,"note":"NA - Not calculated, estimates cannot be calculated due to too few events; Figures from the ClinicalTrials.gov results section (first posted 2024-09-24), not from a publication"},{"name":"Savolitinib Plus Placebo","n":16,"value":13.37,"note":"95% CI 7.82 to NA"}],"source":"https://clinicaltrials.gov/study/NCT04606771?tab=results"},{"endpoint":"Progression-free Survival (PFS)","unit":"months","arms":[{"name":"Savolitinib Plus Osimertinib","n":14,"value":7.36,"note":"95% CI 5.55 to NA; Figures from the ClinicalTrials.gov results section (first posted 2024-09-24), not from a publication"},{"name":"Savolitinib Plus Placebo","n":16,"value":1.64,"note":"95% CI 1.28 to 4.07"}],"source":"https://clinicaltrials.gov/study/NCT04606771?tab=results"}]},{"id":"nct07217301","kind":"trial","name":"A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer","aka":["MarsLight-11"],"tldr":"A phase 3 trial testing TAK-928 in non-small-cell lung cancer, now recruiting.","summary":"A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT07217301, led by Takeda with Innovent Biologics (Suzhou), and recruiting on the registry. Official title: A Randomised, Open Label, Multicenter, Phase 3 Trial Evaluating the Efficacy and Safety of TAK-928 Versus Docetaxel in Participants With Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Disease Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy. Planned enrolment is 600 participants (estimated). The study started in 2025-11-26 and primary completion is expected in 2028-11-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07217301","url":"https://clinicaltrials.gov/study/NCT07217301"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["tak-928"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07217301","phase":"3","setting":"A Randomized, Open Label, Multicenter, Phase 3 Trial Evaluating the Efficacy and Safety of TAK-928 Versus Docetaxel in Participants With Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Disease Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy","sponsor":"Takeda","started":"2025-11-26","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05455320","kind":"trial","name":"A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination Wi","aka":["MonumenTAL-3"],"tldr":"A phase 3 trial of Talquetamab, Daratumumab, Pomalidomide in multiple myeloma, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment is a phase 3 interventional study registered as NCT05455320 by Janssen Research & Development, LLC, with 864 participants enrolled, started 2022-10-13 and due to reach its primary completion in 2027-07-30. Interventions recorded: Talquetamab, Daratumumab, Pomalidomide, Dexamethasone. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05455320","url":"https://clinicaltrials.gov/study/NCT05455320"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","monoclonal-antibody","protac-degrader","t-cell-engager"],"targets":[],"drugs":["talquetamab","daratumumab","pomalidomide","dexamethasone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05455320","phase":"3","setting":"A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy","sponsor":"Janssen Research & Development, LLC","started":"2022-10-13","startedType":"actual","enrolled":864,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06208150","kind":"trial","name":"A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortez","aka":["MonumenTAL-6"],"tldr":"A phase 3 trial of Talquetamab, Pomalidomide, Teclistamab in multiple myeloma, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide is a phase 3 interventional study registered as NCT06208150 by Janssen Research & Development, LLC, with 838 participants enrolled, started 2024-01-22 and due to reach its primary completion in 2026-04-01. Interventions recorded: Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06208150","url":"https://clinicaltrials.gov/study/NCT06208150"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["antiemetic-therapy","monoclonal-antibody","protac-degrader","t-cell-engager"],"targets":[],"drugs":["talquetamab","pomalidomide","teclistamab","elotuzumab","dexamethasone","bortezomib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06208150","phase":"3","setting":"64407564MMY3009: A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pom","sponsor":"Janssen Research & Development, LLC","started":"2024-01-22","startedType":"actual","enrolled":838,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07005128","kind":"trial","name":"A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small","aka":["DeLLphi-312"],"tldr":"A phase 3 trial of Tarlatamab, Durvalumab, Carboplatin in small-cell lung cancer, run by Amgen, active and no longer recruiting.","summary":"A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC) is a phase 3 interventional study registered as NCT07005128 by Amgen, with 350 participants enrolled, started 2025-08-18 and due to reach its primary completion in 2029-01-04. Interventions recorded: Tarlatamab, Durvalumab, Carboplatin, Etoposide. Conditions listed: Small-cell Lung Cancer, Extensive Stage Small-cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07005128","url":"https://clinicaltrials.gov/study/NCT07005128"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","t-cell-engager","topoisomerase-inhibitors"],"targets":[],"drugs":["tarlatamab","durvalumab","carboplatin","etoposide"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07005128","phase":"3","setting":"A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)","sponsor":"Amgen","started":"2025-08-18","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05572515","kind":"trial","name":"A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With","aka":["MajesTEC-9"],"tldr":"A phase 3 trial of Teclistamab, Pomalidomide, Bortezomib in multiple myeloma, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT05572515 by Janssen Research & Development, LLC, with 614 participants enrolled, started 2023-03-29 and due to reach its primary completion in 2025-10-13. Interventions recorded: Teclistamab, Pomalidomide, Bortezomib, Dexamethasone, Carfilzomib. Conditions listed: Relapsed or Refractory Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05572515","url":"https://clinicaltrials.gov/study/NCT05572515"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","kinase-inhibitors","protac-degrader","t-cell-engager"],"targets":[],"drugs":["teclistamab","pomalidomide","bortezomib","dexamethasone","carfilzomib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05572515","phase":"3","setting":"A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide","sponsor":"Janssen Research & Development, LLC","started":"2023-03-29","startedType":"actual","enrolled":614,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06435429","kind":"trial","name":"A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment o","aka":[],"tldr":"A phase 3 trial of Zanidatamab, Trastuzumab, Eribulin in her2-positive breast cancer, run by Jazz Pharmaceuticals, now recruiting.","summary":"A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer is a phase 3 interventional study registered as NCT06435429 by Jazz Pharmaceuticals, with 550 participants planned, started 2024-08-13 and due to reach its primary completion in 2028-04-28. Interventions recorded: Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine. Conditions listed: Metastatic HER2-positive Breast Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06435429","url":"https://clinicaltrials.gov/study/NCT06435429"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["bispecific-antibody","monoclonal-antibody"],"targets":[],"drugs":["zanidatamab","trastuzumab","eribulin","vinorelbine","gemcitabine","capecitabine"],"companies":["jazz"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06435429","phase":"3","setting":"A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, or Are Intolerant to, Previous Trastuzumab Deruxtecan Treatment","sponsor":"Jazz Pharmaceuticals","started":"2024-08-13","startedType":"actual","enrolled":550,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05883956","kind":"trial","name":"A Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia","aka":["PREFER-HMA"],"tldr":"A phase 3 trial of Azacitidine and Decitabine in myelodysplastic syndromes / neoplasms, run by Otsuka Australia Pharmaceutical Pty Ltd, active and no longer recruiting.","summary":"A Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia is a phase 3 interventional study registered as NCT05883956 by Otsuka Australia Pharmaceutical Pty Ltd, with 13 participants enrolled, started 2023-12-20 and due to reach its primary completion in 2024-12-06. Interventions recorded: Subcutaneous azacitidine and Oral decitabine/cedazuridine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05883956","url":"https://clinicaltrials.gov/study/NCT05883956"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mds","mds-higher-risk"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["azacitidine","decitabine"],"companies":["otsuka"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05883956","phase":"3","setting":"A Phase 3b, Randomized, Open-Label, Double Crossover Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Adult Patients With IPSS R Intermediate Myelodysplastic Syndrome, Low Blast Acute Myeloid Leukemia, IPSS Intermediate-2 or High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia","sponsor":"Otsuka Australia Pharmaceutical Pty Ltd","started":"2023-12-20","startedType":"actual","enrolled":13,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05459844","kind":"trial","name":"A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs","aka":[],"tldr":"A phase 3 trial of Lutetium[177Lu] Oxodotreotide Injection in neuroendocrine tumours, run by Sinotau Pharmaceutical Group, active and no longer recruiting.","summary":"A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs is a phase 3 interventional study registered as NCT05459844 by Sinotau Pharmaceutical Group, with 196 participants enrolled, started 2022-08-31 and due to reach its primary completion in 2024-06-26. Interventions recorded: Lutetium[177Lu] Oxodotreotide Injection and Octreotide LAR.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05459844","url":"https://clinicaltrials.gov/study/NCT05459844"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine","pancreatic-net","small-intestinal-net"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sinotau-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05459844","phase":"3","setting":"A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With Inoperable, Progressive, Well Differentiated, Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumours","sponsor":"Sinotau Pharmaceutical Group","started":"2022-08-31","startedType":"actual","enrolled":196,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07711067","kind":"trial","name":"A Study Comparing Whole-Body Heat Treatment Plus Systemic Therapy to Systemic Therapy Alone, for Advanced Pancreatic Cancer","aka":["MATTERS-2"],"tldr":"A phase 2/3 trial in pancreatic cancer, run by ElmediX, not yet recruiting.","summary":"A Study Comparing Whole-Body Heat Treatment Plus Systemic Therapy to Systemic Therapy Alone, for Advanced Pancreatic Cancer is a phase 2/3, randomised interventional study registered as NCT07711067 by ElmediX, with a registry enrolment figure of 95 participants, started 2026-10-01 and due to reach its primary completion in 2030-03-31. Interventions recorded: Whole-body hyperthermia; Standard-of-Care Systemic therapy. Conditions listed: Pancreatic Ductal Adenocarcinoma (mPDAC); Metastatic Pancreatic Ductal Adenocarcinoma (PDAC). Primary outcome: Overall survival (OS); Safety and tolerability of WBHT + SoC and SoC alone. Pancreatic eligibility wording from the registry: \"Subjects with metastatic pancreatic adenocarcinoma (PDAC) confirmed by histology\". Sites: Belgium, Spain. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07711067","url":"https://clinicaltrials.gov/study/NCT07711067"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07711067","phase":"2/3","setting":"A Multi-Centric, Randomized, Pivotal Study, Evaluating Efficacy and Safety of Whole-Body Hyperthermia Alongside Standard Systemic Anticancer Therapy in Patients With Metastatic Pancreatic Cancer After Failure of First Line Treatment.","sponsor":"ElmediX","started":"2026-10-01","startedType":"estimated","enrolled":95,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03539744","kind":"trial","name":"A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) ","aka":[],"tldr":"A phase 3 trial of Pomalidomide, Dexamethasone, Venetoclax in multiple myeloma, run by AbbVie, active and no longer recruiting.","summary":"A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma. is a phase 3 interventional study registered as NCT03539744 by AbbVie, with 265 participants enrolled, started 2018-10-22 and due to reach its primary completion in 2026-08. Interventions recorded: Pomalidomide, Dexamethasone, Venetoclax. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03539744","url":"https://clinicaltrials.gov/study/NCT03539744"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","bcl2-inhibitors","kinase-inhibitors","protac-degrader"],"targets":[],"drugs":["pomalidomide","dexamethasone","venetoclax"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03539744","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma","sponsor":"AbbVie","started":"2018-10-22","startedType":"actual","enrolled":265,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04641754","kind":"trial","name":"A Study Evaluates the Safety and Efficacy of WX-0593 in ALK -Positive, or ROS1-positive Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Iruplinalkib in Non-small-cell lung cancer, run by Qilu Pharmaceutical Co., Ltd., with a status the registry has not verified recently.","summary":"A Study Evaluates the Safety and Efficacy of WX-0593 in ALK -Positive, or ROS1-positive Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT04641754 by Qilu Pharmaceutical Co., Ltd., with 176 participants planned, started 2019-03-07 and due to reach its primary completion in 2020-12. Interventions recorded: WX-0593 Tablets. Conditions recorded: Non-small Cell Lung Cancer.\n\nLinked to the drug Iruplinalkib because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04641754","url":"https://clinicaltrials.gov/study/NCT04641754"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","alk-positive-nsclc","ros1-positive-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["iruplinalkib"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04641754","phase":"2","setting":"Phase II Clinical Study to Evaluate the Efficacy and Safety of WX-0593 in Patients With Crizotinib-resistant ALK -Positive, or Crizotinib-resistant/Crizotinib-naive ROS1-positive Non-small Cell Lung Cancer (NSCLC)","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2019-03-07","startedType":"actual","enrolled":176,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05658003","kind":"trial","name":"A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer","aka":[],"tldr":"A phase 2 trial of [177Lu]Lu-PSMA-617 in prostate cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer is a phase 2 interventional study registered as NCT05658003 by Novartis Pharmaceuticals, with 63 participants enrolled, started 2023-05-05 and due to reach its primary completion in 2024-12-02. Interventions recorded: [177Lu]Lu-PSMA-617, ARDT and [68Ga]Ga-PSMA-11.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05658003","url":"https://clinicaltrials.gov/study/NCT05658003"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["advanced-accelerator-applications"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05658003","phase":"2","setting":"An Open-label, Multi-center, Randomized, Phase II Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer","sponsor":"Novartis Pharmaceuticals","started":"2023-05-05","startedType":"actual","enrolled":63,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07541079","kind":"trial","name":"A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer)","aka":[],"tldr":"A phase 3 trial of Giredestrant in advanced solid tumours, run by Genentech, Inc., now recruiting.","summary":"A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer) is a phase 3 interventional study registered as NCT07541079 by Genentech, Inc., with 300 participants planned, started 2026-08-25 and due to reach its primary completion in 2032-06-30. Interventions recorded: Giredestrant.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07541079","url":"https://clinicaltrials.gov/study/NCT07541079"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["giredestrant"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07541079","phase":"3","setting":"A Phase IIIb, Single-Arm, Open-Label Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes (PRO) of Giredestrant in Patients With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy","sponsor":"Genentech, Inc.","started":"2026-08-25","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04496349","kind":"trial","name":"A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL","aka":[],"tldr":"A phase 2 trial of APG-115 in hodgkin lymphoma, run by Ascentage Pharma Group Inc., now recruiting.","summary":"A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL is a phase 2 interventional study registered as NCT04496349 by Ascentage Pharma Group Inc., with 78 participants planned, started 2021-07-12 and due to reach its primary completion in 2026-05-31. Interventions recorded: APG-115 and APG-2575.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04496349","url":"https://clinicaltrials.gov/study/NCT04496349"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ascentage-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04496349","phase":"2","setting":"A Phase IIa Study Evaluating the Pharmacokinetics, Safety and Efficacy of APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With Relapsed/Refractory T-Cell Prolymphocytic Leukemia (R/R T-PLL) or Non-Hodgkin's Lymphoma (NHL).","sponsor":"Ascentage Pharma Group Inc.","started":"2021-07-12","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05904886","kind":"trial","name":"A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocell","aka":["SKYSCRAPER-14"],"tldr":"A phase 3 trial of Atezolizumab, Bevacizumab, Tiragolumab in hepatocellular carcinoma, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) (IMbrave152) is a phase 3 interventional study registered as NCT05904886 by Hoffmann-La Roche, with 687 participants enrolled, started 2023-09-14 and due to reach its primary completion in 2025-05-08. Interventions recorded: Atezolizumab, Bevacizumab, Tiragolumab, Placebo. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05904886","url":"https://clinicaltrials.gov/study/NCT05904886"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody","tigit-blockade"],"targets":[],"drugs":["atezolizumab","bevacizumab","tiragolumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05904886","phase":"3","setting":"A Phase III, Randomized, Double-blind, Placebo-controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma","sponsor":"Hoffmann-La Roche","started":"2023-09-14","startedType":"actual","enrolled":687,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06096779","kind":"trial","name":"A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirr","aka":["Kirros"],"tldr":"A phase 2 trial of Atezolizumab, Bevacizumab in hepatocellular carcinoma, run by Genentech, Inc., active and no longer recruiting.","summary":"A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis is a phase 2 interventional study registered as NCT06096779 by Genentech, Inc., with 30 participants enrolled, started 2024-07-15 and due to reach its primary completion in 2027-07-30. Interventions recorded: Atezolizumab, Bevacizumab. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06096779","url":"https://clinicaltrials.gov/study/NCT06096779"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["atezolizumab","bevacizumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06096779","phase":"2","setting":"A Phase II, Open-label, Multi-cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis","sponsor":"Genentech, Inc.","started":"2024-07-15","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07739186","kind":"trial","name":"A Study Evaluating BL-B01D1 in Combination With a PD-1/VEGF Bispecific Antibody Versus Tislelizumab Plus Platinum-doublet Chemotherapy as First-line Treatment f","aka":["PANKU-Lung06"],"tldr":"A phase 2/3 trial of izalontamab brengitecan, tislelizumab, pemetrexed, carboplatin and other drugs in lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., not yet recruiting.","summary":"A Study Evaluating BL-B01D1 in Combination With a PD-1/VEGF Bispecific Antibody Versus Tislelizumab Plus Platinum-doublet Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer(PANKU-Lung06) is a phase 2/3, randomised interventional study registered as NCT07739186 by Sichuan Baili Pharmaceutical Co., Ltd., with a registry enrolment figure of 120 participants, started 2026-08 and due to reach its primary completion in 2029-12. Interventions recorded: BL-B01D1; PD-1/VEGF Bispecific Antibody; Tislelizumab; Pemetrexed; Carboplatin; Cisplatin. Conditions listed: Non-squamous Non-small Cell Lung Cancer. Primary outcome: Phase II: Objective Response Rate (ORR); Phase II: Investigator-assessed Progression-free Survival (PFS); Phase III: BICR-assessed Progression-free Survival (PFS). Lung eligibility wording from the registry: \"Patients with locally advanced non-squamous non-small cell lung cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07739186","url":"https://clinicaltrials.gov/study/NCT07739186"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["izalontamab-brengitecan","tislelizumab","pemetrexed","carboplatin","cisplatin"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07739186","phase":"2/3","setting":"A Randomized, Open-label, Multicenter Phase II/III Clinical Study Evaluating BL-B01D1 in Combination With a PD-1/VEGF Bispecific Antibody Versus Tislelizumab Plus Platinum-doublet Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer(PANKU-Lung06)","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-08","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05645692","kind":"trial","name":"A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer","aka":[],"tldr":"A phase 2 trial of Atezolizumab and Tiragolumab in bladder & urothelial cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer is a phase 2 interventional study registered as NCT05645692 by Hoffmann-La Roche, with 204 participants enrolled, started 2023-04-13 and due to reach its primary completion in 2026-12-31. Interventions recorded: Atezolizumab, Tobemstomig and Tiragolumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05645692","url":"https://clinicaltrials.gov/study/NCT05645692"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","tigit-blockade"],"targets":[],"drugs":["atezolizumab","tiragolumab"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05645692","phase":"2","setting":"A Phase II, Randomized, Multicenter, Open-Label, Controlled Study of Tobemstomig Alone or in Combination With Tiragolumab Versus Atezolizumab in Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer Who Are Ineligible for Platinum-Containing Chemotherapy","sponsor":"Hoffmann-La Roche","started":"2023-04-13","startedType":"actual","enrolled":204,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07807163","kind":"trial","name":"A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC","aka":["FORTIFI-FLEX"],"tldr":"A phase 2 trial of Ficerafusp alfa, Pembrolizumab in head and neck squamous cell carcinoma, run by Bicara Therapeutics, now recruiting.","summary":"A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC is a phase 2 interventional study registered as NCT07807163 by Bicara Therapeutics, with 160 participants planned, started 2026-09 and due to reach its primary completion in 2028-03. Interventions recorded: Ficerafusp alfa, Pembrolizumab (KEYTRUDA®). Conditions listed: Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07807163","url":"https://clinicaltrials.gov/study/NCT07807163"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ficerafusp-alfa","pembrolizumab"],"companies":["bicara-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07807163","phase":"2","setting":"A Multicenter, Open-label, Randomized Phase 2 Study Evaluating Continuous Weekly Dosing of Ficerafusp Alfa (BCA101) in Combination With Pembrolizumab Versus an Alternative Ficerafusp Alfa Dosing Regimen for First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","sponsor":"Bicara Therapeutics","started":"2026-09","startedType":"estimated","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06244771","kind":"trial","name":"A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of FMC-376 in non-small-cell lung cancer, colorectal cancer and pancreatic ductal adenocarcinoma, run by Frontier Medicines Corporation, now recruiting.","summary":"A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors is a phase 1/2 interventional study registered as NCT06244771 by Frontier Medicines Corporation, with 403 participants planned, started 2024-02-12 and due to reach its primary completion in 2027-10. Interventions recorded: FMC-376.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06244771","url":"https://clinicaltrials.gov/study/NCT06244771"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","colorectal","pancreatic","kras-g12c-colorectal","kras-g12c-nsclc","kras-g12c-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["frontier-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06244771","phase":"1/2","setting":"An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants With KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors","sponsor":"Frontier Medicines Corporation","started":"2024-02-12","startedType":"actual","enrolled":403,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06970639","kind":"trial","name":"A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases","aka":[],"tldr":"A phase 3 trial of Furmonertinib, Carboplatin, Cisplatin, Pemetrexed and Osimertinib in non-small-cell lung cancer, run by Allist Pharmaceuticals, Inc., now recruiting.","summary":"A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases is a phase 3 interventional study registered as NCT06970639 by Allist Pharmaceuticals, Inc., with 380 participants planned, started 2024-09-26 and due to reach its primary completion in 2029-03. Interventions recorded: Furmonertinib Mesilate Tablets, Carboplatin Injection, Cisplatin for injection, Pemetrexed Disodium for Injection and Osimertinib Mesylate Tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06970639","url":"https://clinicaltrials.gov/study/NCT06970639"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["furmonertinib","carboplatin","cisplatin","pemetrexed","osimertinib"],"companies":["allist"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06970639","phase":"3","setting":"A Phase III, International, Multicenter, Randomized, Controlled, Open-label Clinical Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases","sponsor":"Allist Pharmaceuticals, Inc.","started":"2024-09-26","startedType":"actual","enrolled":380,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07822542","kind":"trial","name":"A Study Evaluating HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Pat","aka":[],"tldr":"A phase 3 trial of adebrelimab, cisplatin, carboplatin, pemetrexed and other drugs in lung cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd., not yet recruiting.","summary":"A Study Evaluating HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT07822542 by Jiangsu Hansoh Pharmaceutical Co., Ltd., with a registry enrolment figure of 448 participants, started 2026-10-31 and due to reach its primary completion in 2030-05-31. Interventions recorded: HS-10370; Adebrelimab; Cisplatin; Carboplatin; Pemetrexed; Tislelizumab. Conditions listed: Carcinoma, Non-Small-Cell Lung. Primary outcome: Progression-Free Survival (PFS). Lung eligibility wording from the registry: \"* Interstitial lung disease (ILD)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07822542","url":"https://clinicaltrials.gov/study/NCT07822542"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["kras-g12c-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["adebrelimab","cisplatin","carboplatin","pemetrexed","tislelizumab"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07822542","phase":"3","setting":"A Randomized, Open-label, Controlled, Multicenter Phase 3 Trial of HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation.","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","started":"2026-10-31","startedType":"estimated","enrolled":448,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03416179","kind":"trial","name":"A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia","aka":[],"tldr":"A phase 3 trial of Glasdegib, CPX-351, Azacitidine and Cytarabine in Leukaemia, run by Pfizer, completed.","summary":"A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia is a phase 3 interventional study registered as NCT03416179 by Pfizer, with 730 participants recorded, started 2018-04-20 and reaching its primary completion in 2020-06-05. Interventions recorded: glasdegib, daunorubicin + cytarabine, azacitidine, Placebo, Placebo, glasdegib, cytarabine, HSCT. Conditions recorded: Leukemia, Myeloid, Acute.\n\nLinked to the drug Glasdegib because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03416179","url":"https://clinicaltrials.gov/study/NCT03416179"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["glasdegib","cpx-351","azacitidine","cytarabine"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03416179","phase":"3","setting":"A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","sponsor":"Pfizer","started":"2018-04-20","startedType":"actual","yearReported":2021,"enrolled":730,"enrolledBasis":"registry","outcomes":[{"endpoint":"Intensive Study: Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Intensive Study: Glasdegib + Cytarabine + Daunorubicin","n":201,"value":17.3,"note":"95% CI 15.2 to 18.5; Figures from the ClinicalTrials.gov results section (first posted 2021-06-25), not from a publication"},{"name":"Intensive Study: Placebo + Cytarabine + Daunorubicin","n":203,"value":20.4,"note":"95% CI 17.6 to NA"}],"hr":1.08,"ci":[0.755,1.532],"p":"0.6579","source":"https://clinicaltrials.gov/study/NCT03416179?tab=results"},{"endpoint":"Non-intensive Study: Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Non-intensive Study: Glasdegib + Azacitidine","n":163,"value":10.3,"note":"95% CI 7.7 to 12.4; Figures from the ClinicalTrials.gov results section (first posted 2021-06-25), not from a publication"},{"name":"Non-intensive Study: Placebo + Azacitidine","n":162,"value":10.6,"note":"95% CI 8.4 to 13.3"}],"hr":1.04,"ci":[0.775,1.388],"p":"0.5955","source":"https://clinicaltrials.gov/study/NCT03416179?tab=results"}]},{"id":"nct07124117","kind":"trial","name":"A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of OBI-902 in advanced solid tumours, run by OBI Pharma, Inc, now recruiting.","summary":"A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07124117 by OBI Pharma, Inc, with 147 participants planned, started 2025-08-04 and due to reach its primary completion in 2029-02-08. Interventions recorded: OBI-902.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07124117","url":"https://clinicaltrials.gov/study/NCT07124117"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["obi-902"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07124117","phase":"1/2","setting":"A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-902 in Participants With Advanced Solid Tumors","sponsor":"OBI Pharma, Inc","started":"2025-08-04","startedType":"actual","enrolled":147,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05920356","kind":"trial","name":"A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants Wi","aka":["CodeBreaK 202"],"tldr":"A phase 3 trial of Sotorasib, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Amgen, now recruiting.","summary":"A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202) is a phase 3 interventional study registered as NCT05920356 by Amgen, with 750 participants planned, started 2023-11-16 and due to reach its primary completion in 2027-06-30. Interventions recorded: Sotorasib, Pembrolizumab. Conditions listed: Non-Small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05920356","url":"https://clinicaltrials.gov/study/NCT05920356"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","kras-g12c-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","kras-inhibitors"],"targets":[],"drugs":["sotorasib","pembrolizumab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05920356","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)","sponsor":"Amgen","started":"2023-11-16","startedType":"actual","enrolled":750,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07321574","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 2 trial of ABP1011T in small-cell lung cancer, run by Shanghai AB PharmaTech Ltd., now recruiting.","summary":"A Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients With Advanced Solid Tumors is a phase 2 interventional study registered as NCT07321574 by Shanghai AB PharmaTech Ltd., with 110 participants planned, started 2025-12-30 and due to reach its primary completion in 2028-11-28. Interventions recorded: ABP1011T.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07321574","url":"https://clinicaltrials.gov/study/NCT07321574"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07321574","phase":"2","setting":"An Open-Label, Multi-Cohort Phase IIb Clinical Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients With Advanced Solid Tumors","sponsor":"Shanghai AB PharmaTech Ltd.","started":"2025-12-30","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04873362","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy","aka":["Astefania"],"tldr":"A phase 3 trial of Atezolizumab, Trastuzumab emtansine and Trastuzumab in HER2-positive breast cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy is a phase 3 interventional study registered as NCT04873362 by Hoffmann-La Roche, with 1188 participants enrolled, started 2021-05-04 and due to reach its primary completion in 2027-03-31. Interventions recorded: Atezolizumab, Trastuzumab Emtansine, Placebo and Trastuzumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04873362","url":"https://clinicaltrials.gov/study/NCT04873362"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["atezolizumab","trastuzumab-emtansine","trastuzumab"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04873362","phase":"3","setting":"A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy","sponsor":"Hoffmann-La Roche","started":"2021-05-04","startedType":"actual","enrolled":1188,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04931342","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors","aka":["BOUQUET"],"tldr":"A phase 2 trial of Ipatasertib, Cobimetinib, Trastuzumab emtansine in ovarian cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors is a phase 2 interventional study registered as NCT04931342 by Hoffmann-La Roche, with 176 participants enrolled, started 2021-10-07 and due to reach its primary completion in 2028-02-28. Interventions recorded: Ipatasertib, Cobimetinib, Trastuzumab Emtansine, Atezolizumab, Bevacizumab. Conditions listed: Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04931342","url":"https://clinicaltrials.gov/study/NCT04931342"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["ipatasertib","cobimetinib","trastuzumab-emtansine","atezolizumab","bevacizumab","paclitaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04931342","phase":"2","setting":"A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors","sponsor":"Hoffmann-La Roche","started":"2021-10-07","startedType":"actual","enrolled":176,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05535244","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multi","aka":["CAMMA 2"],"tldr":"A phase 1/2 trial of Cevostamab, Tocilizumab in multiple myeloma, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT05535244 by Hoffmann-La Roche, with 90 participants planned, started 2022-10-17 and due to reach its primary completion in 2027-02-26. Interventions recorded: Cevostamab, Tocilizumab. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05535244","url":"https://clinicaltrials.gov/study/NCT05535244"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["cevostamab","tocilizumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05535244","phase":"1/2","setting":"A Phase I/II, Open-Label, Multi-Cohort Study to Evaluate the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen-Exposed Patients With Relapsed/Refractory Multiple Myeloma","sponsor":"Hoffmann-La Roche","started":"2022-10-17","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06793215","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Particip","aka":["Krascendo 2"],"tldr":"A phase 3 trial of Divarasib, Pembrolizumab, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by Hoffmann-La Roche, now recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06793215 by Hoffmann-La Roche, with 600 participants planned, started 2025-10-24 and due to reach its primary completion in 2028-11-30. Interventions recorded: Divarasib, Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin. Conditions listed: Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06793215","url":"https://clinicaltrials.gov/study/NCT06793215"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","kras-g12c-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","kras-inhibitors","platinum"],"targets":[],"drugs":["divarasib","pembrolizumab","pemetrexed","carboplatin","cisplatin"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06793215","phase":"3","setting":"A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer","sponsor":"Hoffmann-La Roche","started":"2025-10-24","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04576455","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)","aka":[],"tldr":"A phase 2 trial of Giredestrant and Fulvestrant in HR-positive / HER2-negative breast cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer) is a phase 2 interventional study registered as NCT04576455 by Hoffmann-La Roche, with 303 participants enrolled, started 2020-11-27 and due to reach its primary completion in 2022-02-18. Interventions recorded: Giredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice) and LHRH Agonist. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04576455","url":"https://clinicaltrials.gov/study/NCT04576455"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["giredestrant","fulvestrant"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04576455-j-clin-oncol-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04576455","phase":"2","setting":"A Phase II, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Patients With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer","sponsor":"Hoffmann-La Roche","started":"2020-11-27","startedType":"actual","yearReported":2023,"enrolled":303,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Free Survival (PFS), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)","primary":true,"unit":"months","arms":[{"name":"Giredestrant","n":151,"value":5.55,"note":"95% CI 4.93 to 7.36; Figures from the ClinicalTrials.gov results section (first posted 2023-03-10), not from a publication"},{"name":"Physician's Choice of Endocrine Monotherapy","n":152,"value":5.36,"note":"95% CI 3.71 to 5.55"}],"hr":0.81,"ci":[0.6,1.1],"p":"0.1757","source":"https://clinicaltrials.gov/study/NCT04576455?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Giredestrant","n":151,"value":27.5,"note":"95% CI 23.20 to 32.69; Figures from the ClinicalTrials.gov results section (first posted 2023-03-10), not from a publication"},{"name":"Physician's Choice of Endocrine Monotherapy","n":152,"value":29.77,"note":"95% CI 26.78 to NA"}],"hr":1.16,"ci":[0.85,1.6],"p":"0.3446","source":"https://clinicaltrials.gov/study/NCT04576455?tab=results"}]},{"id":"nct06790693","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer","aka":["INAVO123"],"tldr":"A phase 3 trial of Inavolisib in HR-positive / HER2-negative breast cancer, run by Hoffmann-La Roche, now recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer is a phase 3 interventional study registered as NCT06790693 by Hoffmann-La Roche, with 450 participants planned, started 2025-04-09 and due to reach its primary completion in 2032-01-31. Interventions recorded: Inavolisib, Placebo, CDK4/6i and Letrozole.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06790693","url":"https://clinicaltrials.gov/study/NCT06790693"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["inavolisib"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06790693","phase":"3","setting":"A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer","sponsor":"Hoffmann-La Roche","started":"2025-04-09","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05646862","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy","aka":["INAVO121"],"tldr":"A phase 3 trial of Inavolisib, Fulvestrant and Alpelisib in HR-positive / HER2-negative breast cancer, run by Hoffmann-La Roche, now recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy is a phase 3 interventional study registered as NCT05646862 by Hoffmann-La Roche, with 420 participants planned, started 2023-06-07 and due to reach its primary completion in 2026-11-13. Interventions recorded: Inavolisib, Fulvestrant, Alpelisib, Bupropion, Omeprazole and Midazolam.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05646862","url":"https://clinicaltrials.gov/study/NCT05646862"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["endocrine-therapy","kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["inavolisib","fulvestrant","alpelisib"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05646862","phase":"3","setting":"A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy","sponsor":"Hoffmann-La Roche","started":"2023-06-07","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04712097","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomi","aka":["Celestimo"],"tldr":"A phase 3 trial of Mosunetuzumab, Lenalidomide, Rituximab in follicular lymphoma, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma is a phase 3 interventional study registered as NCT04712097 by Hoffmann-La Roche, with 478 participants enrolled, started 2021-10-27 and due to reach its primary completion in 2026-06-03. Interventions recorded: Mosunetuzumab, Lenalidomide, Rituximab, Tociluzumab. Conditions listed: Relapsed or Refractory Follicular Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04712097","url":"https://clinicaltrials.gov/study/NCT04712097"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["monoclonal-antibody","protac-degrader","t-cell-engager"],"targets":[],"drugs":["mosunetuzumab","lenalidomide","rituximab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04712097","phase":"3","setting":"Phase III Randomized, Open-Label, Multicenter Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a Non-Randomized Single Arm US Extension of Mosunetuzumab in Combination With Lenalidomide in Patients With Follicular Lymphoma After at Least One Line of Systemic Therapy","sponsor":"Hoffmann-La Roche","started":"2021-10-27","startedType":"actual","enrolled":478,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04524871","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Li","aka":["Morpheus-Liver"],"tldr":"A phase 1/2 trial of Atezolizumab, Bevacizumab, Tiragolumab in hepatocellular carcinoma, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) is a phase 1/2 interventional study registered as NCT04524871 by Hoffmann-La Roche, with 518 participants planned, started 2020-11-01 and due to reach its primary completion in 2027-07-30. Interventions recorded: Atezolizumab, Bevacizumab 15 mg/kg, Tiragolumab, Tocilizumab, TPST-1120. Conditions listed: Advanced Liver Cancers. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04524871","url":"https://clinicaltrials.gov/study/NCT04524871"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":["atezolizumab","bevacizumab","tiragolumab","tocilizumab","adg126"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04524871","phase":"1/2","setting":"A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)","sponsor":"Hoffmann-La Roche","started":"2020-11-01","startedType":"actual","enrolled":518,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05170204","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small C","aka":["HORIZON 1"],"tldr":"A phase 3 trial of Alectinib, Entrectinib, Durvalumab in non-small-cell lung cancer and small-cell lung cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) is a phase 3 interventional study registered as NCT05170204 by Hoffmann-La Roche, with 68 participants enrolled, started 2022-11-01 and due to reach its primary completion in 2030-06-16. Interventions recorded: Alectinib, Entrectinib, Durvalumab. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05170204","url":"https://clinicaltrials.gov/study/NCT05170204"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["alectinib","entrectinib","durvalumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05170204","phase":"3","setting":"A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer","sponsor":"Hoffmann-La Roche","started":"2022-11-01","startedType":"actual","enrolled":68,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04802759","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of Giredestrant, Abemaciclib, Ipatasertib, Inavolisib, Ribociclib and Everolimus in HR-positive / HER2-negative breast cancer, run by Hoffmann-La Roche, now recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer is a phase 1/2 interventional study registered as NCT04802759 by Hoffmann-La Roche, with 316 participants planned, started 2021-06-22 and due to reach its primary completion in 2029-05-30. Interventions recorded: Giredestrant, Abemaciclib, Ipatasertib, Inavolisib, Ribociclib and Everolimus.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04802759","url":"https://clinicaltrials.gov/study/NCT04802759"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["giredestrant","abemaciclib","ipatasertib","inavolisib","ribociclib","everolimus","samuraciclib"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04802759","phase":"1/2","setting":"A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS-BREAST CANCER)","sponsor":"Hoffmann-La Roche","started":"2021-06-22","startedType":"actual","enrolled":316,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03424005","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer","aka":["Morpheus-panBC"],"tldr":"A phase 1/2 trial of Capecitabine, Atezolizumab, Ipatasertib, Bevacizumab, Carboplatin and Eribulin in advanced solid tumours, run by Hoffmann-La Roche, now recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer is a phase 1/2 interventional study registered as NCT03424005 by Hoffmann-La Roche, with 1132 participants planned, started 2018-03-30 and due to reach its primary completion in 2030-09-30. Interventions recorded: Capecitabine, Atezolizumab, Ipatasertib, SGN-LIV1A, Bevacizumab and Chemotherapy (Gemcitabine + Carboplatin or Eribulin).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03424005","url":"https://clinicaltrials.gov/study/NCT03424005"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["capecitabine","atezolizumab","ipatasertib","bevacizumab","carboplatin","eribulin","selicrelumab"],"companies":["flatiron-health","gilead","pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03424005","phase":"1/2","setting":"A Phase Ib/II, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)","sponsor":"Hoffmann-La Roche","started":"2018-03-30","startedType":"actual","enrolled":1132,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06588478","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","aka":[],"tldr":"A phase 2 trial of Pirtobrutinib in chronic lymphocytic leukaemia, run by Loxo Oncology, Inc., now recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma is a phase 2 interventional study registered as NCT06588478 by Loxo Oncology, Inc., with 249 participants planned, started 2025-01-03 and due to reach its primary completion in 2028-06. Interventions recorded: Pirtobrutinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06588478","url":"https://clinicaltrials.gov/study/NCT06588478"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["pirtobrutinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06588478","phase":"2","setting":"A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor","sponsor":"Loxo Oncology, Inc.","started":"2025-01-03","startedType":"actual","enrolled":249,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07602777","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202)","aka":[],"tldr":"A phase 1/2 trial of Ris-Rez in sarcomas, run by GlaxoSmithKline, now recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202) is a phase 1/2 interventional study registered as NCT07602777 by GlaxoSmithKline, with 113 participants planned, started 2026-06-22 and due to reach its primary completion in 2027-11-18. Interventions recorded: Ris-Rez and G-CSF.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07602777","url":"https://clinicaltrials.gov/study/NCT07602777"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07602777","phase":"1/2","setting":"Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas","sponsor":"GlaxoSmithKline","started":"2026-06-22","startedType":"actual","enrolled":113,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07589634","kind":"trial","name":"A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relaps","aka":[],"tldr":"A phase 2 trial of JNJ-79635322, Tocilizumab in multiple myeloma, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT07589634 by Janssen Research & Development, LLC, with 230 participants planned, started 2026-06-30 and due to reach its primary completion in 2027-12-31. Interventions recorded: Ramantamig, Tocilizumab, Placebo. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07589634","url":"https://clinicaltrials.gov/study/NCT07589634"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["monoclonal-antibody","t-cell-engager"],"targets":[],"drugs":["jnj-79635322","tocilizumab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07589634","phase":"2","setting":"79635322MMY2002: Phase 2 Randomized, Double-blind, Placebo-controlled Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma","sponsor":"Janssen Research & Development, LLC","started":"2026-06-30","startedType":"actual","enrolled":230,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05885464","kind":"trial","name":"A Study Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL)","aka":["BEAM-201"],"tldr":"A phase 1/2 trial of BEAM-201 in non-Hodgkin lymphoma, run by Beam Therapeutics Inc., active and no longer recruiting.","summary":"A Study Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL) is a phase 1/2 interventional study registered as NCT05885464 by Beam Therapeutics Inc., with 5 participants enrolled, started 2023-05-25 and due to reach its primary completion in 2026-12. Interventions recorded: BEAM-201.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05885464","url":"https://clinicaltrials.gov/study/NCT05885464"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":["cd7"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05885464","phase":"1/2","setting":"A Phase 1/2, Dose-Exploration and Dose-Expansion Study Evaluating the Safety and Efficacy of Multiplex Base-Edited, Allogeneic Anti-CD7 CAR-T Cells (BEAM-201) in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL)","sponsor":"Beam Therapeutics Inc.","started":"2023-05-25","startedType":"actual","enrolled":5,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05417321","kind":"trial","name":"A Study Evaluating the Safety and Efficacy of HB0036 in Subjects With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of HB0036 in non-small-cell lung cancer, run by Shanghai Huaota Biopharmaceutical Co., Ltd., now recruiting.","summary":"A Study Evaluating the Safety and Efficacy of HB0036 in Subjects With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05417321 by Shanghai Huaota Biopharmaceutical Co., Ltd., with 80 participants planned, started 2022-08-25 and due to reach its primary completion in 2025-08-01. Interventions recorded: HB0036.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05417321","url":"https://clinicaltrials.gov/study/NCT05417321"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["hb0036"],"companies":["huabo-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05417321","phase":"1/2","setting":"A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects With Advanced Solid Tumors","sponsor":"Shanghai Huaota Biopharmaceutical Co., Ltd.","started":"2022-08-25","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05583617","kind":"trial","name":"A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma","aka":["PLYCOM"],"tldr":"A phase 1/2 trial of Cevostamab, Lenalidomide, Tocilizumab in multiple myeloma, run by Hoffmann-La Roche, now recruiting.","summary":"A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma is a phase 1/2 interventional study registered as NCT05583617 by Hoffmann-La Roche, with 200 participants planned, started 2023-11-14 and due to reach its primary completion in 2028-07-31. Interventions recorded: Cevostamab, Lenalidomide, Tocilizumab, Iberdomide, Dexamethasone. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05583617","url":"https://clinicaltrials.gov/study/NCT05583617"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["cevostamab","lenalidomide","tocilizumab","iberdomide","dexamethasone"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05583617","phase":"1/2","setting":"A Platform Study Evaluating the Safety and Efficacy of Multiple Treatments in Patients With Multiple Myeloma","sponsor":"Hoffmann-La Roche","started":"2023-11-14","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05893888","kind":"trial","name":"A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers","aka":[],"tldr":"A phase 2/3 trial of Cisplatin in head and neck squamous cell carcinoma, run by Privo Technologies, now recruiting.","summary":"A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers is a phase 2/3 interventional study registered as NCT05893888 by Privo Technologies, with 40 participants planned, started 2024-11-07 and due to reach its primary completion in 2026-10. Interventions recorded: PRV211 (Intraoperative Cisplatin System), PRV111 (Cisplatin Transmucosal System) and PRV131 (Cisplatin Intratumoral Injectable).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05893888","url":"https://clinicaltrials.gov/study/NCT05893888"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","oral-cavity-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05893888","phase":"2/3","setting":"A Phase 1/2/3 Multicenter Study Evaluating the PRV Platform of Localized Nanoengineered Therapies for Oral Cavity and Lung Cancers","sponsor":"Privo Technologies","started":"2024-11-07","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05789082","kind":"trial","name":"A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Par","aka":["KRAScendo 170"],"tldr":"A phase 1/2 trial of Divarasib, Pembrolizumab, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Hoffmann-La Roche, now recruiting.","summary":"A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation is a phase 1/2 interventional study registered as NCT05789082 by Hoffmann-La Roche, with 320 participants planned, started 2023-06-20 and due to reach its primary completion in 2032-01-29. Interventions recorded: Divarasib, Pembrolizumab, Carboplatin, Cisplatin, Pemetrexed. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05789082","url":"https://clinicaltrials.gov/study/NCT05789082"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","kras-g12c-nsclc"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["divarasib","pembrolizumab","carboplatin","cisplatin","pemetrexed"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05789082","phase":"1/2","setting":"A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation","sponsor":"Hoffmann-La Roche","started":"2023-06-20","startedType":"actual","enrolled":320,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05207670","kind":"trial","name":"A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies","aka":["MorningSun"],"tldr":"A phase 2 trial of Mosunetuzumab, Tocilizumab in hodgkin lymphoma and non-hodgkin lymphoma, run by Genentech, Inc., active and no longer recruiting.","summary":"A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies is a phase 2 interventional study registered as NCT05207670 by Genentech, Inc., with 320 participants enrolled, started 2022-02-01 and due to reach its primary completion in 2027-07-31. Interventions recorded: Mosunetuzumab (Cohorts A-C), Mosunetuzumab (Cohorts D-E), Tocilizumab. Conditions listed: Non-Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05207670","url":"https://clinicaltrials.gov/study/NCT05207670"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["mosunetuzumab","tocilizumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05207670","phase":"2","setting":"An Open-Label, Multicenter, Phase II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Subcutaneous Mosunetuzumab Monotherapy in Patients With Select B-Cell Malignancies","sponsor":"Genentech, Inc.","started":"2022-02-01","startedType":"actual","enrolled":320,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04774718","kind":"trial","name":"A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors","aka":[],"tldr":"A phase 1/2 trial of Alectinib in brain and spinal cord tumours, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors is a phase 1/2 interventional study registered as NCT04774718 by Hoffmann-La Roche, with 42 participants enrolled, started 2021-09-14 and due to reach its primary completion in 2032-02-28. Interventions recorded: Alectinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04774718","url":"https://clinicaltrials.gov/study/NCT04774718"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["brain-tumours"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["alectinib"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04774718","phase":"1/2","setting":"A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available","sponsor":"Hoffmann-La Roche","started":"2021-09-14","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04246086","kind":"trial","name":"A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokineti","aka":[],"tldr":"A phase 1/2 trial of Mosunetuzumab, Tocilizumab, Lenalidomide in follicular lymphoma, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma is a phase 1/2 interventional study registered as NCT04246086 by Hoffmann-La Roche, with 237 participants planned, started 2020-08-12 and due to reach its primary completion in 2030-09-06. Interventions recorded: Mosunetuzumab (IV), Tocilizumab, Lenalidomide, Mosunetuzumab (SC). Conditions listed: Follicular Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04246086","url":"https://clinicaltrials.gov/study/NCT04246086"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["protac-degrader","t-cell-engager"],"targets":[],"drugs":["mosunetuzumab","tocilizumab","lenalidomide"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04246086","phase":"1/2","setting":"A Phase Ib/II, Open-Label, Multicenter Study With a Non-Randomized Stage Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab Plus Lenalidomide (+Len), and a Randomized Stage Evaluating the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Patients With Follicular Lymphoma","sponsor":"Hoffmann-La Roche","started":"2020-08-12","startedType":"actual","enrolled":237,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07567846","kind":"trial","name":"A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer","aka":[],"tldr":"A phase 1/2 trial of GDC-1261 in prostate cancer, run by Genentech, Inc., now recruiting.","summary":"A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer is a phase 1/2 interventional study registered as NCT07567846 by Genentech, Inc., with 260 participants planned, started 2026-04-29 and due to reach its primary completion in 2027-11-30. Interventions recorded: GDC-1261.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07567846","url":"https://clinicaltrials.gov/study/NCT07567846"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07567846","phase":"1/2","setting":"A Phase I/II Dose-escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Patients With Advanced or Metastatic Prostate Cancer","sponsor":"Genentech, Inc.","started":"2026-04-29","startedType":"actual","enrolled":260,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05773820","kind":"trial","name":"A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of WJB001 in advanced solid tumours, run by Wigen Biomedicine Technology (Shanghai) Co., Ltd., now recruiting.","summary":"A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05773820 by Wigen Biomedicine Technology (Shanghai) Co., Ltd., with 210 participants planned, started 2023-05-05 and due to reach its primary completion in 2026-08-08. Interventions recorded: WJB001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05773820","url":"https://clinicaltrials.gov/study/NCT05773820"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["wjb001"],"companies":["wigen-biomedicine-technology-shanghai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05773820","phase":"1/2","setting":"A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of WJB001 Capsules in Dose Escalation, Dose Expansion, and Efficacy Expansion in Patients With Advanced Solid Tumors","sponsor":"Wigen Biomedicine Technology (Shanghai) Co., Ltd.","started":"2023-05-05","startedType":"actual","enrolled":210,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06314373","kind":"trial","name":"A Study for HSK39775 in Participants With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of HSK39775 Monotherapy in advanced solid tumours, run by Xizang Haisco Pharmaceutical Co., Ltd, now recruiting.","summary":"A Study for HSK39775 in Participants With Solid Tumors is a phase 1/2 interventional study registered as NCT06314373 by Xizang Haisco Pharmaceutical Co., Ltd, with 243 participants planned, started 2024-03-07 and due to reach its primary completion in 2028-02-01. Interventions recorded: HSK39775 Monotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06314373","url":"https://clinicaltrials.gov/study/NCT06314373"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06314373","phase":"1/2","setting":"A Phase I/II Study to Assess the Safety, Tolerability, PK/PD, and Preliminary Efficacy of HSK39775 Tablet Monotherapy in Participants With Advanced Solid Malignancies","sponsor":"Xizang Haisco Pharmaceutical Co., Ltd","started":"2024-03-07","startedType":"actual","enrolled":243,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02960022","kind":"trial","name":"A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study","aka":[],"tldr":"A phase 2 trial of Enzalutamide, Abiraterone acetate, Prednisone in prostate cancer, run by Astellas Pharma Global Development, Inc., active and no longer recruiting.","summary":"A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study is a phase 2 interventional study registered as NCT02960022 by Astellas Pharma Global Development, Inc., with 900 participants planned, started 2016-12-22 and due to reach its primary completion in 2029-07-31. Interventions recorded: enzalutamide, abiraterone acetate, prednisone, Leuprolide acetate. Conditions listed: Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02960022","url":"https://clinicaltrials.gov/study/NCT02960022"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["enzalutamide","abiraterone","prednisone","goserelin"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02960022","phase":"2","setting":"A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study","sponsor":"Astellas Pharma Global Development, Inc.","started":"2016-12-22","startedType":"actual","enrolled":900,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06689163","kind":"trial","name":"A Study for the Treatment of Metastatic Prostate Cancer With HRS-1167 Tablets Combined With Abiraterone Acetate Tablets and Prednisone","aka":[],"tldr":"A phase 1/2 trial of Prednisone in prostate cancer, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Study for the Treatment of Metastatic Prostate Cancer With HRS-1167 Tablets Combined With Abiraterone Acetate Tablets and Prednisone is a phase 1/2 interventional study registered as NCT06689163 by Jiangsu HengRui Medicine Co., Ltd., with 66 participants planned, started 2024-12-11 and due to reach its primary completion in 2025-11-30. Interventions recorded: HRS-1167 tablets, Abiraterone Acetate tablets（II）, Prednisone Acetate tablets. Conditions listed: Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06689163","url":"https://clinicaltrials.gov/study/NCT06689163"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["prednisone"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06689163","phase":"1/2","setting":"An Open, Multicenter Phase Ib/II Study for the Treatment of Metastatic Prostate Cancer With HRS-1167 Tablets Combined With Abiraterone Acetate Tablets and Prednisone","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2024-12-11","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07541430","kind":"trial","name":"A Study in Adults With Desmoid Tumors","aka":[],"tldr":"A phase 2 trial of ES014 in desmoid tumour, run by Elpiscience (Suzhou) Biopharma, Ltd., now recruiting.","summary":"A Study in Adults With Desmoid Tumors is a phase 2 interventional study registered as NCT07541430 by Elpiscience (Suzhou) Biopharma, Ltd., with 50 participants planned, started 2026-04-30 and due to reach its primary completion in 2028-01. Interventions recorded: ES014.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07541430","url":"https://clinicaltrials.gov/study/NCT07541430"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["desmoid-tumour"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["elpiscience-suzhou-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07541430","phase":"2","setting":"An Open-Label, Multicenter, Single-Arm Phase 2 Study of ES014 in Adult Subjects With Desmoid Tumors","sponsor":"Elpiscience (Suzhou) Biopharma, Ltd.","started":"2026-04-30","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07280377","kind":"trial","name":"A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab","aka":["GOBLET"],"tldr":"A phase 1/2 trial of Atezolizumab, Gemcitabine and Trifluridine/tipiracil in anal cancer and pancreatic ductal adenocarcinoma, run by Oncolytics Biotech, active and no longer recruiting.","summary":"A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab is a phase 1/2 interventional study registered as NCT07280377 by Oncolytics Biotech, with 122 participants enrolled, started 2021-10-27 and due to reach its primary completion in 2027-07-30. Interventions recorded: Pelareorep, Atezolizumab, Gemcitabine and nab-paclitaxel, Trifluridine Tipiracil and mFOLFIRINOX Treatment Regimen.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07280377","url":"https://clinicaltrials.gov/study/NCT07280377"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["anal","pancreatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab","gemcitabine","trifluridine-tipiracil"],"companies":["oncolytics-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07280377","phase":"1/2","setting":"A Phase 1 / 2 Multiple-indication Biomarker, Safety, and Efficacy Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab","sponsor":"Oncolytics Biotech","started":"2021-10-27","startedType":"actual","enrolled":122,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03148418","kind":"trial","name":"A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)","aka":["IMbrella A"],"tldr":"A phase 3 trial of Atezolizumab and Bevacizumab in advanced solid tumours, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A) is a phase 3 interventional study registered as NCT03148418 by Hoffmann-La Roche, with 382 participants enrolled, started 2017-09-20 and due to reach its primary completion in 2026-12-31. Interventions recorded: Atezolizumab and Bevacizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03148418","url":"https://clinicaltrials.gov/study/NCT03148418"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab","bevacizumab"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03148418","phase":"3","setting":"An Open-Label, Multicenter Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study","sponsor":"Hoffmann-La Roche","started":"2017-09-20","startedType":"actual","enrolled":382,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04471727","kind":"trial","name":"A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)","aka":[],"tldr":"A phase 1/2 trial of Atezolizumab, Ifinatamab deruxtecan in small-cell lung cancer, run by Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), active and no longer recruiting.","summary":"A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001) is a phase 1/2 interventional study registered as NCT04471727 by Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), with 232 participants planned, started 2020-12-14 and due to reach its primary completion in 2028-01-28. Interventions recorded: Gocatamig, Atezolizumab, Ifinatamab Deruxtecan (I-DXd). Conditions listed: Small-Cell Lung Cancer, Neuroendocrine Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04471727","url":"https://clinicaltrials.gov/study/NCT04471727"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab","ifinatamab-deruxtecan"],"companies":["harpoon-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04471727","phase":"1/2","setting":"A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 With Atezolizumab or Ifinatamab Deruxtecan (I-DXd) in Patients With Advanced Cancers Associated With Expression of Delta-like Canonical Notch Ligand 3 (DLL3).","sponsor":"Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)","started":"2020-12-14","startedType":"actual","enrolled":232,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03768063","kind":"trial","name":"A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study","aka":["IMbrella B"],"tldr":"A phase 3 trial testing Emactuzumab, active and no longer recruiting.","summary":"A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study is a phase 3 interventional study registered as NCT03768063, led by Hoffmann-La Roche, and active but no longer recruiting on the registry. Official title: An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B). Planned enrolment is 1000 participants (estimated). The study started in 2019-02-28 and primary completion is expected in 2028-07-05. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT03768063","url":"https://clinicaltrials.gov/study/NCT03768063"}],"tags":["ctgov-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":["emactuzumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03768063","phase":"3","setting":"An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)","sponsor":"Hoffmann-La Roche","started":"2019-02-28","startedType":"actual","enrolled":1000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05320588","kind":"trial","name":"A Study in Patients With Advanced Cancers","aka":["StarBridge-1"],"tldr":"A phase 1/2 trial of BIO-106, Pembrolizumab in metastatic cancer, run by BiOneCure Therapeutics Inc., now recruiting.","summary":"A Study in Patients With Advanced Cancers is a phase 1/2 interventional study registered as NCT05320588 by BiOneCure Therapeutics Inc., with 332 participants planned, started 2022-03-25 and due to reach its primary completion in 2024-04. Interventions recorded: BIO-106, Pembrolizumab. Conditions listed: Advanced Cancer, Advanced Solid Tumor, Cancer, Oncology. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05320588","url":"https://clinicaltrials.gov/study/NCT05320588"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["bio-106","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05320588","phase":"1/2","setting":"A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)","sponsor":"BiOneCure Therapeutics Inc.","started":"2022-03-25","startedType":"actual","enrolled":332,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05609370","kind":"trial","name":"A Study Investigating the Efficacy and Safety of Alcestobart (LBL-007) Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus ","aka":[],"tldr":"A phase 1/2 trial of Tislelizumab in colorectal cancer, run by BeiGene, active and no longer recruiting.","summary":"A Study Investigating the Efficacy and Safety of Alcestobart (LBL-007) Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer is a phase 1/2 interventional study registered as NCT05609370 by BeiGene, with 113 participants enrolled, started 2023-01-29 and due to reach its primary completion in 2025-05-23. Interventions recorded: Alcestobart, Tislelizumab, Bevacizumab or Bevacizumab biosimilar, Fluoropyrimidine (FP). Conditions listed: Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05609370","url":"https://clinicaltrials.gov/study/NCT05609370"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05609370","phase":"1/2","setting":"A Phase 1b/2, Randomized, Open-Label Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine as Maintenance Therapy in Patients With Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer","sponsor":"BeiGene","started":"2023-01-29","startedType":"actual","yearReported":2026,"enrolled":113,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Positive Arms A and C","primary":true,"unit":"months","arms":[{"name":"Phase 2: Arm A: PD-L1-positive: Alcestobart High Dose +Tislelizumab +Bevacizumab +Fluoropyrimidine","n":18,"note":"Values could not be estimated due to an insufficient number of events; Figures from the ClinicalTrials.gov results section (first posted 2026-06-30), not from a publication"},{"name":"Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine","n":16,"value":4.4,"note":"95% CI 2.1 to NA"}],"hr":0.37,"ci":[0.1,1.33],"source":"https://clinicaltrials.gov/study/NCT05609370?tab=results"}]},{"id":"nct05142696","kind":"trial","name":"A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab","aka":[],"tldr":"A phase 1/2 trial of Lutetium-177 dotatate, FAP-2286, Atezolizumab in small-cell lung cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab is a phase 1/2 interventional study registered as NCT05142696 by Novartis Pharmaceuticals, with 55 participants enrolled, started 2022-07-13 and due to reach its primary completion in 2028-03-07. Interventions recorded: [177Lu]Lu-DOTA-TATE, Atezolizumab, [68Ga]Ga-DOTA-TATE, Carboplatin, Etoposide. Conditions listed: Extensive Stage Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05142696","url":"https://clinicaltrials.gov/study/NCT05142696"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["lutathera","fap-2286","atezolizumab"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05142696","phase":"1/2","setting":"A Phase Ib/II Dose Finding Study Assessing Safety and Efficacy of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination With Carboplatin, Etoposide, and Atezolizumab in Induction and With Atezolizumab in Maintenance Phase","sponsor":"Novartis Pharmaceuticals","started":"2022-07-13","startedType":"actual","enrolled":55,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04939610","kind":"trial","name":"A Study of 177Lu-FAP-2286 in Advanced Solid Tumors","aka":["LuMIERE"],"tldr":"A phase 1/2 trial of FAP-2286 (177Lu / 68Ga) in advanced solid tumours, run by Novartis Pharmaceuticals, now recruiting.","summary":"A Study of 177Lu-FAP-2286 in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT04939610 by Novartis Pharmaceuticals, with 222 participants planned, started 2021-07-30 and due to reach its primary completion in 2027-12-31. Interventions recorded: 68Ga-FAP-2286 and 177Lu-FAP-2286.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04939610","url":"https://clinicaltrials.gov/study/NCT04939610"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["fapi-pet","radioligand-therapy"],"targets":[],"drugs":["fap-2286"],"companies":["advanced-accelerator-applications"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04939610","phase":"1/2","setting":"LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of 177Lu-FAP-2286 in Patients With an Advanced Solid Tumor","sponsor":"Novartis Pharmaceuticals","started":"2021-07-30","startedType":"actual","enrolled":222,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03303495","kind":"trial","name":"A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC","aka":[],"tldr":"A phase 3 trial of bevacizumab (glioblastoma use) in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC is a phase 3, randomised interventional study registered as NCT03303495 by Sun Yat-sen University, with a registry enrolment figure of 280 participants, started 2011-11-14 and due to reach its primary completion in 2026-12-31. Interventions recorded: Bevacizumab; CPT-11; 5-FU Bolus; 5-FU Infusion; l-LV (dl-LV). Conditions listed: Colorectal Neoplasms; Neoplasm Metastasis; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms. Primary outcome: Progression-free survival (PFS). Colorectal eligibility wording from the registry: \"Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03303495","url":"https://clinicaltrials.gov/study/NCT03303495"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03303495","phase":"3","setting":"A Multinational, Randomized, Phase III Study of FOLFIRI With/Without Bevacizumab Versus Irinotecan With/Without Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer","sponsor":"Sun Yat-sen University","started":"2011-11-14","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06378593","kind":"trial","name":"A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations","aka":[],"tldr":"A phase 1/2 trial of 3HP-2827 in advanced solid tumours, run by 3H (Suzhou) Pharmaceuticals Co., Ltd., now recruiting.","summary":"A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations is a phase 1/2 interventional study registered as NCT06378593 by 3H (Suzhou) Pharmaceuticals Co., Ltd., with 130 participants planned, started 2024-06-17 and due to reach its primary completion in 2028-06-16. Interventions recorded: 3HP-2827.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06378593","url":"https://clinicaltrials.gov/study/NCT06378593"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["fgfr2"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06378593","phase":"1/2","setting":"An Open-Label, Multi-center Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Activity of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations","sponsor":"3H (Suzhou) Pharmaceuticals Co., Ltd.","started":"2024-06-17","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05526755","kind":"trial","name":"A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)","aka":[],"tldr":"A phase 2 trial of Osimertinib in non-small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC) is a phase 2 interventional study registered as NCT05526755 by AstraZeneca, with 188 participants enrolled, started 2023-03-06 and due to reach its primary completion in 2029-11-22. Interventions recorded: Osimertinib 80 mg/40 mg.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05526755","url":"https://clinicaltrials.gov/study/NCT05526755"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05526755","phase":"2","setting":"An Open-label, Single-arm, Phase II, Multinational, Multicentre Study to Assess the Efficacy and Safety of 5 Years of Osimertinib in Participants With EGFRm-positive Stage II-IIIB NSCLC, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy","sponsor":"AstraZeneca","started":"2023-03-06","startedType":"actual","enrolled":188,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07831863","kind":"trial","name":"A Study of 7MW3711 Compared With Docetaxel in Advanced Squamous NSCLC After Prior Chemoimmunotherapy","aka":[],"tldr":"A phase 3 trial of docetaxel in lung cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd., not yet recruiting.","summary":"A Study of 7MW3711 Compared With Docetaxel in Advanced Squamous NSCLC After Prior Chemoimmunotherapy is a phase 3, randomised interventional study registered as NCT07831863 by Mabwell (Shanghai) Bioscience Co., Ltd., with a registry enrolment figure of 600 participants, started 2026-10 and due to reach its primary completion in 2029-03. Interventions recorded: 7MW3711; Docetaxel. Conditions listed: Lung Squamous Cell Carcinoma. Primary outcome: Overall Survival. Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed unresectable locally advanced or metastatic squamous non-small cell lung cancer (NSCLC)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07831863","url":"https://clinicaltrials.gov/study/NCT07831863"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-squamous-cell-carcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":["mabwell-shanghai-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07831863","phase":"3","setting":"A Phase III, Open-label, Randomized-controlled, Multi-center Study of 7MW3711 Compared With Docetaxel in Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer Previously Treated With Platinum-based Chemotherapy and Immunotherapy","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","started":"2026-10","startedType":"estimated","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07556848","kind":"trial","name":"A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 3 trial in triple-negative breast cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd., not yet recruiting.","summary":"A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer is a phase 3, randomised interventional study registered as NCT07556848 by Mabwell (Shanghai) Bioscience Co., Ltd., with a registry enrolment figure of 356 participants, started 2026-05 and due to reach its primary completion in 2027-12. Interventions recorded: 9MW2821; Chemotherapy. Conditions listed: Locally Advanced or Metastatic Triple-negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Histopathological diagnosed triple-negative breast cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07556848","url":"https://clinicaltrials.gov/study/NCT07556848"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["mabwell-shanghai-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07556848","phase":"3","setting":"A Randomized, Open-label, Phase 3 Study to Evaluate 9MW2821 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Have Previously Received Taxane-based Chemotherapy With or Without Immunotherapy and an Antibody-drug Conjugate With a Topoisomerase Inhibitor Payload","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","started":"2026-05","startedType":"estimated","enrolled":356,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05141721","kind":"trial","name":"A Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2/3 trial testing GRT-C901 in colorectal cancer, active and no longer recruiting.","summary":"A Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer is a phase 2/3 interventional study registered as NCT05141721, led by Seattle Project, and active but no longer recruiting on the registry. Official title: A Phase 2/3, Randomised, Open-Label Study of Maintenance GRT-C901/GRT-R902, A Neoantigen Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer. Planned enrolment is 700 participants (estimated). The study started in 2022-02-12 and primary completion is expected in 2027-03. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05141721","url":"https://clinicaltrials.gov/study/NCT05141721"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["grt-c901","grt-r902"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05141721","phase":"2/3","setting":"A Phase 2/3, Randomized, Open-Label Study of Maintenance GRT-C901/GRT-R902, A Neoantigen Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer","sponsor":"Seattle Project","started":"2022-02-12","startedType":"actual","enrolled":700,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05592626","kind":"trial","name":"A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors","aka":["START-001"],"tldr":"A phase 1/2 trial of FOLFIRI, Irinotecan, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by Marengo Therapeutics, Inc., now recruiting.","summary":"A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05592626 by Marengo Therapeutics, Inc., with 366 participants planned, started 2023-01-04 and due to reach its primary completion in 2027-09. Interventions recorded: STAR0602, Irinotecan (Camptosar), Docetaxel (Taxotere). Conditions listed: Advanced Solid Tumors, Genital Neoplasm, Female, Urogenital Neoplasms, Lung Neoplasm. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05592626","url":"https://clinicaltrials.gov/study/NCT05592626"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["folfiri","irinotecan","docetaxel"],"companies":["marengo-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05592626","phase":"1/2","setting":"A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)","sponsor":"Marengo Therapeutics, Inc.","started":"2023-01-04","startedType":"actual","enrolled":366,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07299825","kind":"trial","name":"A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer","aka":[],"tldr":"A phase 2 trial of A166 in HER2-positive breast cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer is a phase 2 interventional study registered as NCT07299825 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 40 participants planned, started 2024-09-20 and due to reach its primary completion in 2027-09-20. Interventions recorded: A166.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07299825","url":"https://clinicaltrials.gov/study/NCT07299825"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["a166"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07299825","phase":"2","setting":"Phase 2 Study of A166 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With TOP1-ADCs","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2024-09-20","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06968585","kind":"trial","name":"A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy","aka":[],"tldr":"A phase 3 trial testing A166 in HER2-positive breast cancer, active and no longer recruiting.","summary":"A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy is a phase 3 interventional study registered as NCT06968585, led by Sichuan Kelun-Biotech Biopharmaceutical, and active but no longer recruiting on the registry. Official title: A Phase III,Multicenter,Randomised,Open-Label,Active-Controlled Trial of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy. Planned enrolment is 365 participants (actual). The study started in 2023-07-18 and primary completion is expected in 2026-11-30. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06968585","url":"https://clinicaltrials.gov/study/NCT06968585"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["a166"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct06968585-j-clin-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06968585","phase":"3","setting":"A Phase III,Multicenter,Randomized,Open-Label,Active-Controlled Trial of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical","started":"2023-07-18","startedType":"actual","enrolled":365,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04395677","kind":"trial","name":"A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene","aka":[],"tldr":"A phase 2 trial of AB-106 in non-small-cell lung cancer, run by Nuvation Bio Inc., active and no longer recruiting.","summary":"A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene is a phase 2 interventional study registered as NCT04395677 by Nuvation Bio Inc., with 173 participants enrolled, started 2020-07-07 and due to reach its primary completion in 2024-06-07. Interventions recorded: AB-106.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04395677","url":"https://clinicaltrials.gov/study/NCT04395677"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","ros1-positive-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["nuvation-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04395677-j-clin-oncol-2024","paper-nct04395677-j-clin-oncol-2026-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04395677","phase":"2","setting":"A Multicenter, Open Label, Single Arm Phase 2 Study of AB-106 in the Treatment of Locally Advanced and Metastatic NSCLC","sponsor":"Nuvation Bio Inc.","started":"2020-07-07","startedType":"actual","enrolled":173,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02107703","kind":"trial","name":"A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer","aka":["MONARCH 2"],"tldr":"A phase 3 trial of Abemaciclib and Fulvestrant in HR-positive / HER2-negative breast cancer, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer is a phase 3 interventional study registered as NCT02107703 by Eli Lilly and Company, with 669 participants enrolled, started 2014-07-22 and due to reach its primary completion in 2017-02-14. Interventions recorded: Abemaciclib, Fulvestrant and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02107703","url":"https://clinicaltrials.gov/study/NCT02107703"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy"],"targets":[],"drugs":["abemaciclib","fulvestrant"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02107703-j-clin-oncol-2017","paper-nct02107703-jama-oncol-2020-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02107703","phase":"3","setting":"MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer","sponsor":"Eli Lilly and Company","started":"2014-07-22","startedType":"actual","yearReported":2018,"enrolled":669,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Abemaciclib + Fulvestrant","n":446,"value":16.4,"note":"95% CI 14.4 to 19.3; Figures from the ClinicalTrials.gov results section (first posted 2018-03-13), not from a publication"},{"name":"Placebo + Fulvestrant","n":223,"value":9.3,"note":"95% CI 7.4 to 11.4"}],"hr":0.553,"ci":[0.449,0.681],"p":"<0.0000001","source":"https://clinicaltrials.gov/study/NCT02107703?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Abemaciclib + Fulvestrant","n":446,"value":45.8,"note":"95% CI 38.96 to 52.64; Figures from the ClinicalTrials.gov results section (first posted 2018-03-13), not from a publication"},{"name":"Placebo + Fulvestrant","n":223,"value":37.25,"note":"95% CI 34.36 to 43.20"}],"source":"https://clinicaltrials.gov/study/NCT02107703?tab=results"},{"endpoint":"Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])","unit":"%","arms":[{"name":"Abemaciclib + Fulvestrant","n":446,"value":35.2,"note":"95% CI 30.8 to 39.6; Figures from the ClinicalTrials.gov results section (first posted 2018-03-13), not from a publication"},{"name":"Placebo + Fulvestrant","n":223,"value":16.1,"note":"95% CI 11.3 to 21.0"}],"source":"https://clinicaltrials.gov/study/NCT02107703?tab=results"}]},{"id":"nct02763566","kind":"trial","name":"A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer","aka":[],"tldr":"A phase 3 trial of Abemaciclib and Fulvestrant in advanced solid tumours, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer is a phase 3 interventional study registered as NCT02763566 by Eli Lilly and Company, with 463 participants enrolled, started 2016-12-05 and due to reach its primary completion in 2019-03-29. Interventions recorded: Abemaciclib, Anastrozole, Letrozole, Placebo and Fulvestrant. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02763566","url":"https://clinicaltrials.gov/study/NCT02763566"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy"],"targets":[],"drugs":["abemaciclib","fulvestrant","anastrozole"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02763566","phase":"3","setting":"A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer","sponsor":"Eli Lilly and Company","started":"2016-12-05","startedType":"actual","yearReported":2020,"enrolled":463,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)","primary":true,"unit":"months","arms":[{"name":"Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)","n":207,"note":"Median and Upper bound were not estimable due to Immature data.; Figures from the ClinicalTrials.gov results section (first posted 2020-03-30), not from a publication"},{"name":"Placebo + NSAI","n":99,"value":14.73,"note":"95% CI 11.21 to 18.87"}],"hr":0.499,"ci":[0.346,0.719],"p":"0.0001","source":"https://clinicaltrials.gov/study/NCT02763566?tab=results"},{"endpoint":"Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]","unit":"%","arms":[{"name":"Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)","n":207,"value":56,"note":"95% CI 49.3 to 62.8; Figures from the ClinicalTrials.gov results section (first posted 2020-03-30), not from a publication"},{"name":"Placebo + NSAI","n":99,"value":30.3,"note":"95% CI 21.3 to 39.4"},{"name":"Abemaciclib + Fulvestrant","n":104,"value":38.5,"note":"95% CI 29.1 to 47.8"},{"name":"Placebo + Fulvestrant","n":53,"value":7.5,"note":"95% CI 0.4 to 14.7"}],"source":"https://clinicaltrials.gov/study/NCT02763566?tab=results"}]},{"id":"nct02152631","kind":"trial","name":"A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer","aka":["JUNIPER"],"tldr":"A phase 3 trial of Abemaciclib, Erlotinib in non-small-cell lung cancer and small-cell lung cancer, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer is a phase 3 interventional study registered as NCT02152631 by Eli Lilly and Company, with 453 participants enrolled, started 2014-10-03 and due to reach its primary completion in 2017-09-15. Interventions recorded: Abemaciclib, Erlotinib. Conditions listed: Non Small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2018; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02152631","url":"https://clinicaltrials.gov/study/NCT02152631"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["cdk46-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["abemaciclib","erlotinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02152631-front-oncol-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02152631","phase":"3","setting":"JUNIPER: A Randomized Phase 3 Study of Abemaciclib Plus Best Supportive Care Versus Erlotinib Plus Best Supportive Care in Patients With Stage IV NSCLC With a Detectable KRAS Mutation Who Have Progressed After Platinum-Based Chemotherapy","sponsor":"Eli Lilly and Company","started":"2014-10-03","startedType":"actual","yearReported":2018,"enrolled":453,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Abemaciclib","n":270,"value":7.4,"note":"95% CI 6.5 to 8.8; Figures from the ClinicalTrials.gov results section (first posted 2018-12-12), not from a publication"},{"name":"Erlotinib","n":183,"value":7.8,"note":"95% CI 6.4 to 9.5"}],"hr":0.968,"ci":[0.768,1.219],"p":"0.771","source":"https://clinicaltrials.gov/study/NCT02152631?tab=results"},{"endpoint":"Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Abemaciclib","n":270,"value":3.6,"note":"95% CI 2.8 to 3.8; Figures from the ClinicalTrials.gov results section (first posted 2018-12-12), not from a publication"},{"name":"Erlotinib","n":183,"value":1.9,"note":"95% CI 1.9 to 2.0"}],"hr":0.583,"ci":[0.47,0.723],"p":"<0.000001","source":"https://clinicaltrials.gov/study/NCT02152631?tab=results"},{"endpoint":"Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])","unit":"%","arms":[{"name":"Abemaciclib","n":270,"value":8.9,"note":"95% CI 5.5 to 12.3; Figures from the ClinicalTrials.gov results section (first posted 2018-12-12), not from a publication"},{"name":"Erlotinib","n":183,"value":2.7,"note":"95% CI 0.4 to 5.1"}],"p":"0.010","source":"https://clinicaltrials.gov/study/NCT02152631?tab=results"}]},{"id":"nct02747004","kind":"trial","name":"A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer","aka":["Next MONARCH 1"],"tldr":"A phase 2 trial of Abemaciclib and Tamoxifen in advanced solid tumours, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer is a phase 2 interventional study registered as NCT02747004 by Eli Lilly and Company, with 234 participants enrolled, started 2016-09-14 and due to reach its primary completion in 2018-06-15. Interventions recorded: Abemaciclib, Tamoxifen and Prophylactic Loperamide. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02747004","url":"https://clinicaltrials.gov/study/NCT02747004"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy"],"targets":[],"drugs":["abemaciclib","tamoxifen"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02747004","phase":"2","setting":"A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer","sponsor":"Eli Lilly and Company","started":"2016-09-14","startedType":"actual","yearReported":2019,"enrolled":234,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"150mg Abemaciclib + 20mg Tamoxifen","n":78,"value":9.07,"note":"95% CI 6.90 to 10.95; Figures from the ClinicalTrials.gov results section (first posted 2019-07-12), not from a publication"},{"name":"150mg Abemaciclib","n":79,"value":6.48,"note":"95% CI 4.77 to 9.21"},{"name":"200mg Abemaciclib + 2mg Prophylactic Loperamide","n":77,"value":7.43,"note":"95% CI 5.42 to 9.17"}],"source":"https://clinicaltrials.gov/study/NCT02747004?tab=results"},{"endpoint":"Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)","unit":"%","arms":[{"name":"150mg Abemaciclib + 20mg Tamoxifen","n":78,"value":34.6,"note":"95% CI 24.1 to 45.2; Figures from the ClinicalTrials.gov results section (first posted 2019-07-12), not from a publication"},{"name":"150mg Abemaciclib","n":79,"value":24.1,"note":"95% CI 14.6 to 33.5"},{"name":"200mg Abemaciclib + 2mg Prophylactic Loperamide","n":77,"value":32.5,"note":"95% CI 22 to 42.9"}],"source":"https://clinicaltrials.gov/study/NCT02747004?tab=results"}]},{"id":"nct05288166","kind":"trial","name":"A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)","aka":["CYCLONE 3"],"tldr":"A phase 3 trial of Abemaciclib and Prednisone in prostate cancer, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) is a phase 3 interventional study registered as NCT05288166 by Eli Lilly and Company, with 925 participants enrolled, started 2022-04-14 and due to reach its primary completion in 2024-02-15. Interventions recorded: Abemaciclib, Abiraterone, Prednisone or Prednisolone and Placebo for Abemaciclib. Results have been posted on the registry.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05288166","url":"https://clinicaltrials.gov/study/NCT05288166"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["abemaciclib","prednisone"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05288166","phase":"3","setting":"CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer","sponsor":"Eli Lilly and Company","started":"2022-04-14","startedType":"actual","enrolled":925,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03706365","kind":"trial","name":"A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer","aka":["CYCLONE 2"],"tldr":"A phase 2/3 trial of Abemaciclib, Abiraterone acetate, Prednisone in prostate cancer, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer is a phase 2/3 interventional study registered as NCT03706365 by Eli Lilly and Company, with 393 participants enrolled, started 2018-11-26 and due to reach its primary completion in 2024-01-02. Interventions recorded: Abemaciclib, Placebo, Abiraterone acetate, Prednisone. Conditions listed: Prostate Cancer. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03706365","url":"https://clinicaltrials.gov/study/NCT03706365"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation","cdk46-inhibitor"],"targets":[],"drugs":["abemaciclib","abiraterone","prednisone"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03706365-lancet-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03706365","phase":"2/3","setting":"A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer","sponsor":"Eli Lilly and Company","started":"2018-11-26","startedType":"actual","yearReported":2025,"enrolled":393,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic Progression Free Survival (rPFS)","primary":true,"unit":"months","arms":[{"name":"Abemaciclib","n":206,"value":21.96,"note":"95% CI 19.33 to 27.48; Figures from the ClinicalTrials.gov results section (first posted 2025-03-06), not from a publication"},{"name":"Placebo","n":187,"value":20.28,"note":"95% CI 16.47 to 24.36"}],"hr":0.829,"ci":[0.619,1.111],"p":"0.2123","source":"https://clinicaltrials.gov/study/NCT03706365?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Abemaciclib","n":206,"value":38.01,"note":"95% CI 30.58 to 46.65; Figures from the ClinicalTrials.gov results section (first posted 2025-03-06), not from a publication"},{"name":"Placebo","n":187,"value":33.21,"note":"95% CI 29.52 to NA"}],"hr":0.927,"ci":[0.669,1.285],"p":"0.6507","source":"https://clinicaltrials.gov/study/NCT03706365?tab=results"},{"endpoint":"Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)","unit":"%","arms":[{"name":"Abemaciclib","n":84,"value":45.2,"note":"95% CI 34.6 to 55.9; Figures from the ClinicalTrials.gov results section (first posted 2025-03-06), not from a publication"},{"name":"Placebo","n":73,"value":54.8,"note":"95% CI 43.4 to 66.2"}],"source":"https://clinicaltrials.gov/study/NCT03706365?tab=results"}]},{"id":"nct07244705","kind":"trial","name":"A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC","aka":[],"tldr":"A phase 1/2 trial of ABT-301, Tislelizumab, Bevacizumab in colorectal cancer, run by Anbogen Therapeutics, Inc., now recruiting.","summary":"A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC is a phase 1/2 interventional study registered as NCT07244705 by Anbogen Therapeutics, Inc., with 66 participants planned, started 2025-11 and due to reach its primary completion in 2028-04. Interventions recorded: ABT-301, Tislelizumab, Bevacizumab (Avastin). Conditions listed: Colorectal Cancer (Diagnosis), Colorectal Cancer Metastatic, Colorectal Cancer (CRC), Immunotherapy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07244705","url":"https://clinicaltrials.gov/study/NCT07244705"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["abt-301","tislelizumab","bevacizumab"],"companies":["anbogen-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07244705","phase":"1/2","setting":"An Open-label, Multicenter, Phase 1/2 Study Exploring the Safety and Efficacy of ABT-301 in Combination With Tislelizumab and Bevacizumab in Participants With Proficient Mismatch Repair (pMMR)/Non-Microsatellite Instability-High (Non-MSI-H) Locally Advanced or Metastatic Colorectal Cancer (mCRC)","sponsor":"Anbogen Therapeutics, Inc.","started":"2025-11","startedType":"estimated","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05951959","kind":"trial","name":"A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma","aka":["TrAVeRse"],"tldr":"A phase 2 trial of Acalabrutinib, Venetoclax, Rituximab in mantle cell lymphoma, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma is a phase 2 interventional study registered as NCT05951959 by AstraZeneca, with 108 participants enrolled, started 2023-12-13 and due to reach its primary completion in 2028-10-31. Interventions recorded: Acalabrutinib, Venetoclax, Rituximab. Conditions listed: Mantle Cell Lymphoma (MCL). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05951959","url":"https://clinicaltrials.gov/study/NCT05951959"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["acalabrutinib","venetoclax","rituximab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05951959","phase":"2","setting":"A Multicentre, Phase II, Open-label Study to Evaluate the Efficacy of Acalabrutinib in Combination With Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma (TrAVeRse)","sponsor":"AstraZeneca","started":"2023-12-13","startedType":"actual","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05057494","kind":"trial","name":"A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","aka":["MAJIC"],"tldr":"A phase 3 trial of Acalabrutinib, Venetoclax and Obinutuzumab in chronic lymphocytic leukaemia, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma is a phase 3 interventional study registered as NCT05057494 by AstraZeneca, with 607 participants enrolled, started 2022-09-12 and due to reach its primary completion in 2027-07-15. Interventions recorded: Acalabrutinib, Venetoclax and Obinutuzumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05057494","url":"https://clinicaltrials.gov/study/NCT05057494"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["acalabrutinib","venetoclax","obinutuzumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05057494","phase":"3","setting":"A Phase III Prospective, Multicenter, Randomized, Open-Label Trial of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","sponsor":"AstraZeneca","started":"2022-09-12","startedType":"actual","enrolled":607,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02970318","kind":"trial","name":"A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL","aka":[],"tldr":"A phase 3 trial of Acalabrutinib, Rituximab, Idelalisib and Bendamustine in chronic lymphocytic leukaemia, run by Acerta Pharma BV, active and no longer recruiting.","summary":"A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL is a phase 3 interventional study registered as NCT02970318 by Acerta Pharma BV, with 310 participants enrolled, started 2017-02-02 and due to reach its primary completion in 2021-09-03. Interventions recorded: Acalabrutinib (ACP-196), Rituximab, Idelalisib and Bendamustine. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02970318","url":"https://clinicaltrials.gov/study/NCT02970318"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["acalabrutinib","rituximab","idelalisib","bendamustine"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02970318","phase":"3","setting":"A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia","sponsor":"Acerta Pharma BV","started":"2017-02-02","startedType":"actual","yearReported":2023,"enrolled":310,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment","primary":true,"unit":"months","arms":[{"name":"Arm A: Acalabrutinib Monotherapy","n":155,"note":"Kaplan-Meier Estimated Median PFS and 95% were not reached for Arm A.; Figures from the ClinicalTrials.gov results section (first posted 2023-06-29), not from a publication"},{"name":"Arm B: Investigators Choice","n":155,"value":16.5,"note":"95% CI 14.0 to 17.1"}],"hr":0.31,"ci":[0.2,0.49],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT02970318?tab=results"},{"endpoint":"IRC-assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 15 January 2019 From Interim Analysis","unit":"participants","arms":[{"name":"Arm A: Acalabrutinib Monotherapy","n":155,"value":126,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-06-29), not from a publication"},{"name":"Arm B: Investigator's Choice","n":155,"value":117}],"p":"0.2248","source":"https://clinicaltrials.gov/study/NCT02970318?tab=results"}]},{"id":"nct02717611","kind":"trial","name":"A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy","aka":[],"tldr":"A phase 2 trial of Acalabrutinib in chronic lymphocytic leukaemia, run by Acerta Pharma BV, active and no longer recruiting.","summary":"A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy is a phase 2 interventional study registered as NCT02717611 by Acerta Pharma BV, with 60 participants enrolled, started 2016-03-08 and due to reach its primary completion in 2020-10-16. Interventions recorded: ACP-196 (acalabrutinib). Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02717611","url":"https://clinicaltrials.gov/study/NCT02717611"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["acalabrutinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02717611","phase":"2","setting":"A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy","sponsor":"Acerta Pharma BV","started":"2016-03-08","startedType":"actual","yearReported":2022,"enrolled":60,"enrolledBasis":"registry","outcomes":[{"endpoint":"The Overall Response Rate (ORR) of ACP-196 (Acalabrutinib)","primary":true,"unit":"%","arms":[{"name":"Acalabrutinib","n":60,"value":70,"note":"95% CI 56.8 to 81.2; Figures from the ClinicalTrials.gov results section (first posted 2022-02-09), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT02717611?tab=results"}]},{"id":"nct06875310","kind":"trial","name":"A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)","aka":["KRYSTAL-4"],"tldr":"A phase 3 trial of Adagrasib, Pembrolizumab, Carboplatin, Pemetrexed and Cisplatin in non-small-cell lung cancer, run by Mirati Therapeutics Inc., now recruiting.","summary":"A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4) is a phase 3 interventional study registered as NCT06875310 by Mirati Therapeutics Inc., with 630 participants planned, started 2025-04-24 and due to reach its primary completion in 2029-09-07. Interventions recorded: Adagrasib, Pembrolizumab, Carboplatin, Pemetrexed, Placebo and Cisplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06875310","url":"https://clinicaltrials.gov/study/NCT06875310"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","kras-inhibitors"],"targets":[],"drugs":["adagrasib","pembrolizumab","carboplatin","pemetrexed","cisplatin"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06875310","phase":"3","setting":"A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)","sponsor":"Mirati Therapeutics Inc.","started":"2025-04-24","startedType":"actual","enrolled":630,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04673942","kind":"trial","name":"A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors","aka":["BETA-PRIME"],"tldr":"A phase 2 trial of AdAPT-001 in sarcomas, run by EpicentRx, Inc., active and no longer recruiting.","summary":"A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors is a phase 2 interventional study registered as NCT04673942 by EpicentRx, Inc., with 140 participants enrolled, started 2021-03-29 and due to reach its primary completion in 2026-12-01. Interventions recorded: AdAPT-001 and Checkpoint Inhibitor, Immune.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04673942","url":"https://clinicaltrials.gov/study/NCT04673942"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["epicentrx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04673942","phase":"2","setting":"An Adapted Phase 2a/2b, Study to Evaluate the Safety, Tolerability, and Efficacy of AdAPT-001 in Subjects With Refractory Solid Tumors","sponsor":"EpicentRx, Inc.","started":"2021-03-29","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04557059","kind":"trial","name":"A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer","aka":["PRIMORDIUM"],"tldr":"A phase 3 trial of Apalutamide in prostate cancer, run by Janssen Pharmaceutica N.V., Belgium, active and no longer recruiting.","summary":"A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer is a phase 3 interventional study registered as NCT04557059 by Janssen Pharmaceutica N.V., Belgium, with 691 participants enrolled, started 2020-11-12 and due to reach its primary completion in 2029-08-27. Interventions recorded: Radiotherapy, LHRHa and Apalutamide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04557059","url":"https://clinicaltrials.gov/study/NCT04557059"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["apalutamide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04557059","phase":"3","setting":"A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET With an Observational Cohort","sponsor":"Janssen Pharmaceutica N.V., Belgium","started":"2020-11-12","startedType":"actual","enrolled":691,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06111235","kind":"trial","name":"A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT","aka":[],"tldr":"A phase 3 trial of Cretostimogene grenadenorepvec in bladder & urothelial cancer, run by CG Oncology, Inc., active and no longer recruiting.","summary":"A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT is a phase 3 interventional study registered as NCT06111235 by CG Oncology, Inc., with 367 participants enrolled, started 2023-12-14 and due to reach its primary completion in 2026-11. Interventions recorded: Cretostimogene Grenadenorepvec.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06111235","url":"https://clinicaltrials.gov/study/NCT06111235"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["oncolytic-virus"],"targets":[],"drugs":["cretostimogene"],"companies":["cg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06111235","phase":"3","setting":"A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec Versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)","sponsor":"CG Oncology, Inc.","started":"2023-12-14","startedType":"actual","enrolled":367,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06307431","kind":"trial","name":"A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).","aka":["INTerpath-004"],"tldr":"A phase 2 trial of Intismeran autogene, Pembrolizumab in renal cell carcinoma, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004). is a phase 2 interventional study registered as NCT06307431 by Merck Sharp & Dohme LLC, with 272 participants planned, started 2024-04-10 and due to reach its primary completion in 2028-01-08. Interventions recorded: Intismeran autogene, Pembrolizumab, Placebo. Conditions listed: Renal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06307431","url":"https://clinicaltrials.gov/study/NCT06307431"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":["checkpoint-inhibitor","neoantigen-mrna-vaccine"],"targets":[],"drugs":["intismeran-autogene","pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06307431","phase":"2","setting":"A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma (INTerpath-004).","sponsor":"Merck Sharp & Dohme LLC","started":"2024-04-10","startedType":"actual","enrolled":272,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01882868","kind":"trial","name":"A Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan","aka":[],"tldr":"A phase 2 trial of Ziv-aflibercept, Irinotecan and Fluorouracil in Colorectal cancer, run by Sanofi, completed.","summary":"A Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan is a phase 2 interventional study registered as NCT01882868 by Sanofi, with 62 participants recorded, started 2013-07 and reaching its primary completion in 2015-08. Interventions recorded: Aflibercept, Levofolinate, Irinotecan, 5-FU. Conditions recorded: Colorectal Cancer Metastatic.\n\nLinked to the drug Ziv-aflibercept because the registry names it among its interventions and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01882868","url":"https://clinicaltrials.gov/study/NCT01882868"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["ziv-aflibercept","irinotecan","fluorouracil"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01882868","phase":"2","setting":"A Single-Arm Phase II Study in Japan to Assess the Efficacy and Safety of Aflibercept Administered Every Two Weeks in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer Who Progressed During or Following an Oxaliplatin-Based Regimen","sponsor":"Sanofi","started":"2013-07","yearReported":2017,"enrolled":62,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Overall Response","primary":true,"unit":"%","arms":[{"name":"Aflibercept + FOLFIRI","n":60,"value":8.3,"note":"95% CI 1.3 to 15.3; Figures from the ClinicalTrials.gov results section (first posted 2017-03-14), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01882868?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Aflibercept + FOLFIRI","n":62,"value":15.59,"note":"95% CI 11.203 to 19.811; Figures from the ClinicalTrials.gov results section (first posted 2017-03-14), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01882868?tab=results"},{"endpoint":"Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Aflibercept + FOLFIRI","n":62,"value":5.42,"note":"95% CI 4.140 to 6.702; Figures from the ClinicalTrials.gov results section (first posted 2017-03-14), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01882868?tab=results"}]},{"id":"nct06617416","kind":"trial","name":"A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC","aka":[],"tldr":"A phase 3 trial of Cadonilimab, Sugemalimab in non-small-cell lung cancer and small-cell lung cancer, run by Akeso, now recruiting.","summary":"A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC is a phase 3 interventional study registered as NCT06617416 by Akeso, with 560 participants planned, started 2024-11-12 and due to reach its primary completion in 2026-10-28. Interventions recorded: Cadonilimab (AK104), Sugemalimab. Conditions listed: NSCLC (Non-small Cell Lung Cancer). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06617416","url":"https://clinicaltrials.gov/study/NCT06617416"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["cadonilimab","sugemalimab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06617416","phase":"3","setting":"A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Consolidation Therapy of AK104 Versus Sugemalimab in Patients With Unresectable Locally Advanced Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent or Sequential Chemoradiotherapy","sponsor":"Akeso","started":"2024-11-12","startedType":"actual","enrolled":560,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05859750","kind":"trial","name":"A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of Cadonilimab, Gemcitabine, Leucovorin (folinic acid) and Oxaliplatin in pancreatic ductal adenocarcinoma, run by Akeso, now recruiting.","summary":"A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer is a phase 2 interventional study registered as NCT05859750 by Akeso, with 78 participants planned, started 2023-05-25 and due to reach its primary completion in 2025-06. Interventions recorded: AK104, Gemcitabine, Nab-Paclitaxel, Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate and Oxaliplatin + Irinotecan + 5-Fluorouracil/Leucovorin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05859750","url":"https://clinicaltrials.gov/study/NCT05859750"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["cadonilimab","gemcitabine","leucovorin","oxaliplatin"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05859750","phase":"2","setting":"A Multicenter, Open-label, Phase II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Combination With Chemotherapy as First-line Treatment in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer","sponsor":"Akeso","started":"2023-05-25","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05235516","kind":"trial","name":"A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer","aka":[],"tldr":"A phase 3 trial of Cadonilimab and Cisplatin in cervical cancer, run by Akeso, active and no longer recruiting.","summary":"A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer is a phase 3 interventional study registered as NCT05235516 by Akeso, with 636 participants enrolled, started 2022-06-21 and due to reach its primary completion in 2026-05. Interventions recorded: AK104, EBRT, BT, cisplatin and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05235516","url":"https://clinicaltrials.gov/study/NCT05235516"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cervical","locally-advanced-cervical-cancer"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["cadonilimab","cisplatin"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05235516","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer","sponsor":"Akeso","started":"2022-06-21","startedType":"actual","enrolled":636,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05990127","kind":"trial","name":"A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of cadonilimab, tislelizumab, carboplatin, pemetrexed and other drugs in lung cancer, run by Akeso, not yet recruiting.","summary":"A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT05990127 by Akeso, with a registry enrolment figure of 642 participants, started 2023-11-14 and due to reach its primary completion in 2025-08-05. Interventions recorded: AK104; Tislelizumab; carboplatin; Pemetrexed; Paclitaxel. Conditions listed: Locally Advanced or Metastatic NSCLC. Primary outcome: Overall Survival(OS); Progression-Free Survival(PFS) by investigator(INV). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not amenable to complete surgical resection and not amenable to radical concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer \\[AJCC\\] 8th edition)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05990127","url":"https://clinicaltrials.gov/study/NCT05990127"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cadonilimab","tislelizumab","carboplatin","pemetrexed","paclitaxel"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05990127","phase":"3","setting":"A Randomized, Double-blind, Phase III Trial to Compare the Efficacy and Safety of AK104 Combined With Chemotherapy to Tislelizumab Combined With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer (NSCLC)","sponsor":"Akeso","started":"2023-11-14","startedType":"estimated","enrolled":642,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06371157","kind":"trial","name":"A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepat","aka":[],"tldr":"A phase 3 trial of Cadonilimab, Lenvatinib in hepatocellular carcinoma, run by Akeso, now recruiting.","summary":"A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma is a phase 3 interventional study registered as NCT06371157 by Akeso, with 469 participants planned, started 2024-08-02 and due to reach its primary completion in 2025-10-25. Interventions recorded: AK104, Lenvatinib, TACE, Placebo for AK104, Placebo for Lenvatinib. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06371157","url":"https://clinicaltrials.gov/study/NCT06371157"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-intermediate"],"sections":[],"technologies":["antiangiogenic","bispecific-antibody","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["cadonilimab","lenvatinib"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06371157","phase":"3","setting":"A Phase III, Randomized, Double-blinded, Multicenter Study of Cadonilimab (AK104) + Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma","sponsor":"Akeso","started":"2024-08-02","startedType":"actual","enrolled":469,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05142423","kind":"trial","name":"A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of AK109+AK104 in advanced solid tumours, run by Akeso, now recruiting.","summary":"A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05142423 by Akeso, with 198 participants planned, started 2021-11-03 and due to reach its primary completion in 2027-04. Interventions recorded: AK109+AK104.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05142423","url":"https://clinicaltrials.gov/study/NCT05142423"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05142423","phase":"1/2","setting":"An Open Label, Multi-center, Phase Ib/II Clinical Study of AK109 Combined With AK104 to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Advanced Solid Tumors","sponsor":"Akeso","started":"2021-11-03","startedType":"actual","enrolled":198,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07010263","kind":"trial","name":"A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemor","aka":[],"tldr":"A phase 3 trial of Ivonescimab in small-cell lung cancer, run by Akeso, now recruiting.","summary":"A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy is a phase 3 interventional study registered as NCT07010263 by Akeso, with 560 participants planned, started 2025-06-13 and due to reach its primary completion in 2028-12-31. Interventions recorded: AK112, Placebo. Conditions listed: Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07010263","url":"https://clinicaltrials.gov/study/NCT07010263"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","limited-stage-sclc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07010263","phase":"3","setting":"A Multicenter, Randomized, Double-blind, Phase III Clinical Study of Comparing the Efficacy and Safety of AK112 (PD-1/VEGF Bispecific Antibody) Versus Placebo as Consolidation Treatment for Patients With Limited Stage Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy","sponsor":"Akeso","started":"2025-06-13","startedType":"actual","enrolled":560,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07357220","kind":"trial","name":"A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases","aka":[],"tldr":"A phase 1/2 trial of ivonescimab in colorectal cancer, run by Akeso, not yet recruiting.","summary":"A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases is a phase 1/2, randomised interventional study registered as NCT07357220 by Akeso, with a registry enrolment figure of 72 participants, started 2026-03-02 and due to reach its primary completion in 2027-02-28. Interventions recorded: VG2025; AK112. Conditions listed: Colorectal Cancer With Hepatic Metastases. Primary outcome: Number of participants experiencing dose-limiting toxicities (DLTs); Number of participants with adverse events (AEs) and severity; Objective Response Rate (ORR). Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed unresectable colorectal cancer with liver metastases; adenocarcinoma type\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07357220","url":"https://clinicaltrials.gov/study/NCT07357220"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07357220","phase":"1/2","setting":"A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of AK112 in Combination With VG2025 in Patients With Advanced Colorectal Cancer With Liver Metastases","sponsor":"Akeso","started":"2026-03-02","startedType":"estimated","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06530251","kind":"trial","name":"A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC)","aka":[],"tldr":"A phase 1/2 trial of Ivonescimab, Cadonilimab, Sintilimab in hepatocellular carcinoma, run by Akeso, now recruiting.","summary":"A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC) is a phase 1/2 interventional study registered as NCT06530251 by Akeso, with 280 participants planned, started 2024-09-24 and due to reach its primary completion in 2026-06. Interventions recorded: AK112, Cadonilimab, AK127, AK130, Sintilimab Injection. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06530251","url":"https://clinicaltrials.gov/study/NCT06530251"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":["ivonescimab","cadonilimab","sintilimab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06530251","phase":"1/2","setting":"A Phase Ib/II Study of AK112 in Combination Therapy for Patients With Advanced Hepatocellular Carcinoma (HCC)","sponsor":"Akeso","started":"2024-09-24","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05382442","kind":"trial","name":"A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of Ivonescimab, AK117, CAPOX in colorectal cancer, run by Akeso, active and no longer recruiting.","summary":"A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer is a phase 2 interventional study registered as NCT05382442 by Akeso, with 254 participants planned, started 2022-06-27 and due to reach its primary completion in 2026-05-15. Interventions recorded: AK112, AK117, Oxaliplatin, Capecitabine, Irinotecan. Conditions listed: Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05382442","url":"https://clinicaltrials.gov/study/NCT05382442"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["ivonescimab","ak117","capox","capecitabine","folfiri","flot"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05382442","phase":"2","setting":"A Phase II Study of AK112 With or Without AK117 for Patients With Metastatic Colorectal Cancer","sponsor":"Akeso","started":"2022-06-27","startedType":"actual","enrolled":254,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05227664","kind":"trial","name":"A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of AK117 in triple-negative breast cancer, run by Akeso, active and no longer recruiting.","summary":"A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer is a phase 2 interventional study registered as NCT05227664 by Akeso, with 120 participants enrolled, started 2022-03-23 and due to reach its primary completion in 2026-12-30. Interventions recorded: AK117, AK112, Nab paclitaxel and paclitaxel.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05227664","url":"https://clinicaltrials.gov/study/NCT05227664"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["ak117"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05227664-nat-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05227664","phase":"2","setting":"A Phase II Study of AK117/AK112 in Combination With Chemotherapy for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer","sponsor":"Akeso","started":"2022-03-23","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06938321","kind":"trial","name":"A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 1/2 trial of AK112 in biliary tract cancer, run by Akeso, now recruiting.","summary":"A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer is a phase 1/2 interventional study registered as NCT06938321 by Akeso, with 135 participants planned, started 2025-04-30 and due to reach its primary completion in 2027-05. Interventions recorded: AK112 and AK130.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06938321","url":"https://clinicaltrials.gov/study/NCT06938321"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06938321","phase":"1/2","setting":"An Open Label, Multicenter, Phase Ib/II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer","sponsor":"Akeso","started":"2025-04-30","startedType":"actual","enrolled":135,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07114315","kind":"trial","name":"A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of AK112 in pancreatic ductal adenocarcinoma, run by Akeso, now recruiting.","summary":"A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer is a phase 2 interventional study registered as NCT07114315 by Akeso, with 160 participants planned, started 2025-09-19 and due to reach its primary completion in 2027-08. Interventions recorded: AK112 and AK130.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07114315","url":"https://clinicaltrials.gov/study/NCT07114315"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07114315","phase":"2","setting":"A Phase II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer","sponsor":"Akeso","started":"2025-09-19","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07623356","kind":"trial","name":"A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of Ivonescimab, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Akeso, now recruiting.","summary":"A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT07623356 by Akeso, with 265 participants planned, started 2026-07-07 and due to reach its primary completion in 2028-06-18. Interventions recorded: AK138D1, Ivonescimab, Carboplatin. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07623356","url":"https://clinicaltrials.gov/study/NCT07623356"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab","carboplatin"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07623356","phase":"1/2","setting":"A Phase Ib/II Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Non-Small Cell Lung Cancer","sponsor":"Akeso","started":"2026-07-07","startedType":"actual","enrolled":265,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04871282","kind":"trial","name":"A Study of AL102 in Patients With Progressing Desmoid Tumors","aka":["RINGSIDE"],"tldr":"A phase 2/3 trial testing Varegacestat in desmoid tumour, active and no longer recruiting.","summary":"A Study of AL102 in Patients With Progressing Desmoid Tumours is a phase 2/3 interventional study registered as NCT04871282, led by Immunome, and active but no longer recruiting on the registry. Official title: RINGSIDE: A Phase 2/3, Randomised, Multicenter Study to Evaluate AL102 in Patients With Progressing Desmoid Tumours. Planned enrolment is 198 participants (actual). The study started in 2021-09-01 and primary completion is expected in 2025-12-03. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04871282","url":"https://clinicaltrials.gov/study/NCT04871282"}],"tags":["ctgov-ingest"],"related":[],"cancers":["desmoid-tumour"],"sections":[],"technologies":[],"targets":[],"drugs":["varegacestat"],"companies":["immunome"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04871282","phase":"2/3","setting":"RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients With Progressing Desmoid Tumors","sponsor":"Immunome","started":"2021-09-01","startedType":"actual","enrolled":198,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06860971","kind":"trial","name":"A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma","aka":[],"tldr":"A phase 3 trial testing AL2846 in thyroid cancer, now recruiting.","summary":"A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma is a phase 3 interventional study registered as NCT06860971, led by Chia Tai Tianqing Pharmaceutical, and recruiting on the registry. Official title: A Randomised, Double-Blind, Multicenter Phase III Clinical Trial Evaluating AL2846 Capsule Versus Placebo in Patients With Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma Who Failed Prior VEGFR-Targeted Therapy. Planned enrolment is 144 participants (estimated). The study started in 2025-04-18 and primary completion is expected in 2027-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06860971","url":"https://clinicaltrials.gov/study/NCT06860971"}],"tags":["ctgov-ingest"],"related":[],"cancers":["thyroid"],"sections":[],"technologies":[],"targets":[],"drugs":["al2846"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06860971","phase":"3","setting":"A Randomized, Double-Blind, Multicenter Phase III Clinical Trial Evaluating AL2846 Capsule Versus Placebo in Patients With Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma Who Failed Prior VEGFR-Targeted Therapy","sponsor":"Chia Tai Tianqing Pharmaceutical","started":"2025-04-18","startedType":"actual","enrolled":144,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07465757","kind":"trial","name":"A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)","aka":["ALISCA-Lung2"],"tldr":"A phase 2 trial of Paclitaxel / nab-paclitaxel in small-cell lung cancer, run by Puma Biotechnology, Inc., now recruiting.","summary":"A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC) is a phase 2 interventional study registered as NCT07465757 by Puma Biotechnology, Inc., with 50 participants planned, started 2026-09-30 and due to reach its primary completion in 2028-03-31. Interventions recorded: Alisertib, Alisertib, Alisertib, Alisertib, Alisertib. Conditions listed: Small Cell Lung Cancer ( SCLC ). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07465757","url":"https://clinicaltrials.gov/study/NCT07465757"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["paclitaxel"],"companies":["puma-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07465757","phase":"2","setting":"A Phase 2 Study of Alisertib in Combination With Paclitaxel in Patients With Small Cell Lung Cancer","sponsor":"Puma Biotechnology, Inc.","started":"2026-09-17","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06369285","kind":"trial","name":"A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer","aka":["ALISCA-Breast1"],"tldr":"A phase 2 trial of Alisertib in HR-positive / HER2-negative breast cancer, run by Puma Biotechnology, Inc., now recruiting.","summary":"A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer is a phase 2 interventional study registered as NCT06369285 by Puma Biotechnology, Inc., with 225 participants planned, started 2024-11-19 and due to reach its primary completion in 2027-12-30. Interventions recorded: Alisertib and Endocrine therapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06369285","url":"https://clinicaltrials.gov/study/NCT06369285"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["alisertib"],"companies":["puma-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06369285","phase":"2","setting":"A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer","sponsor":"Puma Biotechnology, Inc.","started":"2024-11-19","startedType":"actual","enrolled":225,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06095505","kind":"trial","name":"A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer","aka":["ALISCA-Lung1"],"tldr":"A phase 2 trial of Alisertib in small-cell lung cancer, run by Puma Biotechnology, Inc., now recruiting.","summary":"A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer is a phase 2 interventional study registered as NCT06095505 by Puma Biotechnology, Inc., with 120 participants planned, started 2024-02-08 and due to reach its primary completion in 2027-10-30. Interventions recorded: Alisertib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06095505","url":"https://clinicaltrials.gov/study/NCT06095505"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["alisertib"],"companies":["puma-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06095505","phase":"2","setting":"A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer","sponsor":"Puma Biotechnology, Inc.","started":"2024-02-08","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06385080","kind":"trial","name":"A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer","aka":["OrigAMI-4"],"tldr":"A phase 1/2 trial of Amivantamab, Pembrolizumab and Carboplatin in head and neck squamous cell carcinoma, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer is a phase 1/2 interventional study registered as NCT06385080 by Janssen Research & Development, LLC, with 287 participants planned, started 2024-04-22 and due to reach its primary completion in 2032-12-27. Interventions recorded: Amivantamab, Pembrolizumab, Paclitaxel and Carboplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06385080","url":"https://clinicaltrials.gov/study/NCT06385080"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":["bispecific-antibody"],"targets":[],"drugs":["amivantamab","pembrolizumab","carboplatin"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06385080","phase":"1/2","setting":"A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Other Therapeutic Agents in Participants With Head and Neck Squamous Cell Carcinoma","sponsor":"Janssen Research & Development, LLC","started":"2024-04-22","startedType":"actual","enrolled":287,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05488314","kind":"trial","name":"A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer","aka":["METalmark"],"tldr":"A phase 1/2 trial of Capmatinib and Amivantamab in non-small-cell lung cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT05488314 by Janssen Research & Development, LLC, with 57 participants enrolled, started 2022-12-13 and due to reach its primary completion in 2027-04-28. Interventions recorded: Capmatinib and Amivantamab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05488314","url":"https://clinicaltrials.gov/study/NCT05488314"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["bispecific-antibody","kinase-inhibitors"],"targets":[],"drugs":["capmatinib","amivantamab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05488314","phase":"1/2","setting":"A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer","sponsor":"Janssen Research & Development, LLC","started":"2022-12-13","startedType":"actual","enrolled":57,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06750094","kind":"trial","name":"A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy","aka":["OrigAMI-3"],"tldr":"A phase 3 trial of Amivantamab, Cetuximab, Bevacizumab and Leucovorin (folinic acid) in colorectal cancer, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy is a phase 3 interventional study registered as NCT06750094 by Janssen Research & Development, LLC, with 700 participants planned, started 2024-12-12 and due to reach its primary completion in 2027-12-15. Interventions recorded: Amivantamab, Cetuximab, Bevacizumab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin and Irinotecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06750094","url":"https://clinicaltrials.gov/study/NCT06750094"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","bispecific-antibody","monoclonal-antibody"],"targets":[],"drugs":["amivantamab","cetuximab","bevacizumab","leucovorin"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06750094","phase":"3","setting":"A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy","sponsor":"Janssen Research & Development, LLC","started":"2024-12-12","startedType":"actual","enrolled":700,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04988295","kind":"trial","name":"A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure","aka":["MARIPOSA-2"],"tldr":"A phase 3 trial of Lazertinib, Amivantamab, Pemetrexed and Carboplatin in non-small-cell lung cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure is a phase 3 interventional study registered as NCT04988295 by Janssen Research & Development, LLC, with 776 participants enrolled, started 2021-11-17 and due to reach its primary completion in 2023-07-10. Interventions recorded: Lazertinib, Amivantamab, Pemetrexed and Carboplatin. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04988295","url":"https://clinicaltrials.gov/study/NCT04988295"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["bispecific-antibody","kinase-inhibitors"],"targets":[],"drugs":["lazertinib","amivantamab","pemetrexed","carboplatin"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04988295","phase":"3","setting":"A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure","sponsor":"Janssen Research & Development, LLC","started":"2021-11-17","startedType":"actual","yearReported":2025,"enrolled":776,"enrolledBasis":"registry","outcomes":[{"endpoint":"Main Study: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)","primary":true,"unit":"months","arms":[{"name":"Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)","n":263,"value":8.31,"note":"95% CI 6.77 to 9.10; Figures from the ClinicalTrials.gov results section (first posted 2025-04-16), not from a publication"},{"name":"Main Study: Arm B: Carboplatin + Pemetrexed (CP)","n":263,"value":4.17,"note":"95% CI 4.04 to 4.44"},{"name":"Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP)","n":131,"value":6.28,"note":"95% CI 5.55 to 8.41"}],"source":"https://clinicaltrials.gov/study/NCT04988295?tab=results"}]},{"id":"nct06662786","kind":"trial","name":"A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer","aka":["OrigAMI-2"],"tldr":"A phase 3 trial of Amivantamab, Cetuximab, Leucovorin (folinic acid) and Oxaliplatin in colorectal cancer, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer is a phase 3 interventional study registered as NCT06662786 by Janssen Research & Development, LLC, with 1000 participants planned, started 2024-10-18 and due to reach its primary completion in 2028-12-15. Interventions recorded: Amivantamab, Cetuximab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin, Oxaliplatin and Irinotecan Hydrochloride.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06662786","url":"https://clinicaltrials.gov/study/NCT06662786"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["bispecific-antibody","monoclonal-antibody"],"targets":[],"drugs":["amivantamab","cetuximab","leucovorin","oxaliplatin"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06662786","phase":"3","setting":"A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer","sponsor":"Janssen Research & Development, LLC","started":"2024-10-18","startedType":"actual","enrolled":1000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07227025","kind":"trial","name":"A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer","aka":["KaRAnaSa"],"tldr":"A phase 1/2 trial of Amivantamab and Olomorasib in non-small-cell lung cancer, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT07227025 by Janssen Research & Development, LLC, with 60 participants planned, started 2026-03-03 and due to reach its primary completion in 2028-11-30. Interventions recorded: Amivantamab and Olomorasib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07227025","url":"https://clinicaltrials.gov/study/NCT07227025"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["bispecific-antibody","kras-inhibitors"],"targets":[],"drugs":["amivantamab","olomorasib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07227025","phase":"1/2","setting":"A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic Non-small Cell Lung Cancer","sponsor":"Janssen Research & Development, LLC","started":"2026-03-03","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07276399","kind":"trial","name":"A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer","aka":["OrigAMI-5"],"tldr":"A phase 3 trial of Amivantamab, Pembrolizumab, Carboplatin and Cisplatin in head and neck squamous cell carcinoma, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer is a phase 3 interventional study registered as NCT07276399 by Janssen Research & Development, LLC, with 500 participants planned, started 2025-12-03 and due to reach its primary completion in 2029-06-18. Interventions recorded: Amivantamab, Pembrolizumab, Carboplatin, 5-Flurouracil and Cisplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07276399","url":"https://clinicaltrials.gov/study/NCT07276399"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["amivantamab","pembrolizumab","carboplatin","cisplatin"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07276399","phase":"3","setting":"A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants With Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma","sponsor":"Janssen Research & Development, LLC","started":"2025-12-03","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06667076","kind":"trial","name":"A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","aka":["COPERNICUS"],"tldr":"A phase 2 trial of Amivantamab, Lazertinib, Pemetrexed and Carboplatin in non-small-cell lung cancer, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) is a phase 2 interventional study registered as NCT06667076 by Janssen Research & Development, LLC, with 480 participants planned, started 2024-12-16 and due to reach its primary completion in 2029-05-23. Interventions recorded: Amivantamab, Lazertinib, Chemotherapy: Pemetrexed and Chemotherapy: Carboplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06667076","url":"https://clinicaltrials.gov/study/NCT06667076"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["bispecific-antibody","kinase-inhibitors"],"targets":[],"drugs":["amivantamab","lazertinib","pemetrexed","carboplatin"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06667076","phase":"2","setting":"A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Janssen Research & Development, LLC","started":"2024-12-16","startedType":"actual","enrolled":480,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05498428","kind":"trial","name":"A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Amivantamab, Lazertinib, Carboplatin and Pemetrexed in non-small-cell lung cancer, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT05498428 by Janssen Research & Development, LLC, with 520 participants planned, started 2022-11-11 and due to reach its primary completion in 2027-08-17. Interventions recorded: Amivantamab, Lazertinib, Carboplatin, Pemetrexed, Direct Oral Anticoagulant (DOAC) and Low Molecular Weight Heparin (LMWH).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05498428","url":"https://clinicaltrials.gov/study/NCT05498428"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["bispecific-antibody"],"targets":[],"drugs":["amivantamab","lazertinib","carboplatin","pemetrexed"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05498428","phase":"2","setting":"A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer","sponsor":"Janssen Research & Development, LLC","started":"2022-11-11","startedType":"actual","enrolled":520,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05379595","kind":"trial","name":"A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer","aka":["OrigAMI-1"],"tldr":"A phase 1/2 trial of Amivantamab, Fluorouracil, FLOT in colorectal cancer, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer is a phase 1/2 interventional study registered as NCT05379595 by Janssen Research & Development, LLC, with 225 participants planned, started 2022-07-29 and due to reach its primary completion in 2027-04-27. Interventions recorded: Amivantamab IV, Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan. Conditions listed: Advanced or Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05379595","url":"https://clinicaltrials.gov/study/NCT05379595"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["bispecific-antibody"],"targets":[],"drugs":["amivantamab","fluorouracil","flot","capox","folfiri"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05379595-j-clin-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05379595","phase":"1/2","setting":"A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer","sponsor":"Janssen Research & Development, LLC","started":"2022-07-29","startedType":"actual","enrolled":225,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06777316","kind":"trial","name":"A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of CGT4859 in biliary tract cancer, run by Cogent Biosciences, Inc., active and no longer recruiting.","summary":"A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06777316 by Cogent Biosciences, Inc., with 110 participants enrolled, started 2025-01-22 and due to reach its primary completion in 2027-03. Interventions recorded: CGT4859.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06777316","url":"https://clinicaltrials.gov/study/NCT06777316"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma","intrahepatic-cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["cgt4859"],"companies":["cogent-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06777316","phase":"1/2","setting":"A Phase 1/2 Study of a Selective FGFR2/3 Inhibitor, CGT4859, in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors Harboring FGFR2 and/or FGFR3 Genetic Alterations","sponsor":"Cogent Biosciences, Inc.","started":"2025-01-22","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05884398","kind":"trial","name":"A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC","aka":["LIBERTAS"],"tldr":"A phase 3 trial of Apalutamide in prostate cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC is a phase 3 interventional study registered as NCT05884398 by Janssen Research & Development, LLC, with 420 participants enrolled, started 2023-08-31 and due to reach its primary completion in 2026-10-12. Interventions recorded: Apalutamide, Androgen-deprivation Therapy (ADT). Conditions listed: Metastatic Castrate-sensitive Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05884398","url":"https://clinicaltrials.gov/study/NCT05884398"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["apalutamide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05884398","phase":"3","setting":"A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide With Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) Following PSA Response in Participants With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)","sponsor":"Janssen Research & Development, LLC","started":"2023-08-31","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04854668","kind":"trial","name":"A Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Can","aka":[],"tldr":"A phase 3 trial of Anlotinib, Bevacizumab, CAPOX in colorectal cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., active and no longer recruiting.","summary":"A Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer is a phase 3 interventional study registered as NCT04854668 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with 748 participants enrolled, started 2021-05-27 and due to reach its primary completion in 2024-12-31. Interventions recorded: Anlotinib hydrochloride capsule, Bevacizumab, Oxaliplatin, Capecitabine. Conditions listed: Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04854668","url":"https://clinicaltrials.gov/study/NCT04854668"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["anlotinib","bevacizumab","capox","capecitabine"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04854668-signal-transduct-target-ther-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04854668","phase":"3","setting":"A Randomized, Open-label, Parallel Controlled, Multi-center Phase III Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2021-05-27","startedType":"actual","enrolled":748,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05094336","kind":"trial","name":"A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)","aka":["MTAPESTRY 101"],"tldr":"A phase 1/2 trial of Anvumetostat and Docetaxel in advanced solid tumours, run by Amgen, active and no longer recruiting.","summary":"A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) is a phase 1/2 interventional study registered as NCT05094336 by Amgen, with 329 participants enrolled, started 2022-02-01 and due to reach its primary completion in 2026-11-30. Interventions recorded: Anvumetostat, Docetaxel and Comparator Anvumetostat Test Tablet.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05094336","url":"https://clinicaltrials.gov/study/NCT05094336"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["anvumetostat","docetaxel"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05094336","phase":"1/2","setting":"A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Anvumetostat Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors","sponsor":"Amgen","started":"2022-02-01","startedType":"actual","enrolled":329,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06669975","kind":"trial","name":"A Study of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of AP402 (Part 1 Dose esclation) in advanced solid tumours, run by AP Biosciences Inc., now recruiting.","summary":"A Study of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06669975 by AP Biosciences Inc., with 85 participants planned, started 2025-04-22 and due to reach its primary completion in 2026-12-01. Interventions recorded: AP402 (Part 1 Dose esclation) and AP402 (Part 2 Dose Expansion).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06669975","url":"https://clinicaltrials.gov/study/NCT06669975"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ap-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06669975","phase":"1/2","setting":"A Phase 1/2, Open-label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors","sponsor":"AP Biosciences Inc.","started":"2025-04-22","startedType":"actual","enrolled":85,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01946204","kind":"trial","name":"A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer","aka":["SPARTAN"],"tldr":"A phase 3 trial of Apalutamide in prostate cancer, run by Aragon Pharmaceuticals, Inc., active and no longer recruiting.","summary":"A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer is a phase 3 interventional study registered as NCT01946204 by Aragon Pharmaceuticals, Inc., with 1207 participants enrolled, started 2013-10-14 and due to reach its primary completion in 2017-05-19. Interventions recorded: Apalutamide and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01946204","url":"https://clinicaltrials.gov/study/NCT01946204"},{"label":"SPARTAN (New England Journal of Medicine 2018)","url":"https://doi.org/10.1056/NEJMoa1715546"},{"label":"NICE TA740: apalutamide with androgen deprivation therapy for treating high-risk hormone-relapsed non-metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta740"},{"label":"NICE TA660: darolutamide with androgen deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta660"},{"label":"NICE TA580: enzalutamide for hormone-relapsed non-metastatic prostate cancer, not recommended","url":"https://www.nice.org.uk/guidance/ta580"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-nmcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["apalutamide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["prostate-uk-drug-approvals"],"trials":["prosper","aramis","nct02489318"],"people":[],"bottlenecks":[],"keyPapers":["paper-spartan-nejm-2018"],"journals":[],"dependsOn":[],"notes":["SPARTAN randomised 1,207 men with non-metastatic castration-resistant prostate cancer and a PSA doubling time of 10 months or less 2:1 to apalutamide 240 mg daily or placebo, all continuing androgen deprivation. The primary analysis was performed after 378 events. Adverse events leading to discontinuation occurred in 10.6 percent on apalutamide and 7.0 percent on placebo; rash occurred in 23.8 against 5.5 percent and hypothyroidism in 8.1 against 2.0 percent (New England Journal of Medicine 2018).","In England NICE TA740 recommends apalutamide with androgen deprivation for hormone-relapsed non-metastatic prostate cancer at high risk of metastasising, defining high risk as a PSA that has doubled in 10 months or less on continuous androgen deprivation. NICE TA660 recommends darolutamide with androgen deprivation for the same population. NICE TA580 does not recommend enzalutamide there: the committee accepted that it extends the time until the cancer spreads, found no evidence that it extends life, and judged the cost-effectiveness estimates too uncertain and outside the usual range.","This disease state is partly an artefact of imaging. Men classified as non-metastatic on CT and bone scan, which is how SPARTAN, PROSPER and ARAMIS staged them, are frequently found to have metastases on PSMA PET."],"nct":"NCT01946204","phase":"3","setting":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer","sponsor":"Aragon Pharmaceuticals, Inc.","result":"Median metastasis-free survival 40.5 months with apalutamide added to androgen deprivation against 16.2 months with placebo (hazard ratio 0.28, 95 percent confidence interval 0.23 to 0.35, p<0.001); rash 23.8 against 5.5 percent and fracture 11.7 against 6.5 percent.","started":"2013-10-14","startedType":"actual","yearReported":2018,"enrolled":1207,"enrolledBasis":"registry","outcomes":[{"endpoint":"Metastasis-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Apalutamide with androgen deprivation","n":806,"value":40.5},{"name":"Placebo with androgen deprivation","n":401,"value":16.2}],"hr":0.28,"ci":[0.23,0.35],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1715546"},{"endpoint":"Time to symptomatic progression","arms":[{"name":"Apalutamide with androgen deprivation","n":806},{"name":"Placebo with androgen deprivation","n":401}],"hr":0.45,"ci":[0.32,0.63],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1715546"},{"endpoint":"Fracture, any grade","unit":"%","arms":[{"name":"Apalutamide with androgen deprivation","n":806,"value":11.7},{"name":"Placebo with androgen deprivation","n":401,"value":6.5}],"source":"https://doi.org/10.1056/NEJMoa1715546"}],"replication":"PROSPER with enzalutamide and ARAMIS with darolutamide found metastasis-free survival benefits of the same size in the same setting."},{"id":"nct02489318","kind":"trial","name":"A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC","aka":["TITAN"],"tldr":"A phase 3 trial of Apalutamide in prostate cancer, run by Aragon Pharmaceuticals, Inc., active and no longer recruiting.","summary":"A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC is a phase 3 interventional study registered as NCT02489318 by Aragon Pharmaceuticals, Inc., with 1052 participants enrolled, started 2015-11-27 and due to reach its primary completion in 2020-09-07. Interventions recorded: Apalutamide, Placebo, Androgen Deprivation Therapy (ADT). Conditions listed: Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02489318","url":"https://clinicaltrials.gov/study/NCT02489318"},{"label":"TITAN (New England Journal of Medicine 2019)","url":"https://doi.org/10.1056/NEJMoa1903307"},{"label":"NICE TA741: apalutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta741"},{"label":"NICE TA1109: darolutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta1109"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["apalutamide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":["arches","enzamet","latitude","aranote","nct01946204"],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02489318-n-engl-j-med-2019"],"journals":[],"dependsOn":[],"notes":["TITAN was a double-blind phase 3 trial in men with metastatic castration-sensitive prostate cancer, randomised to apalutamide 240 mg daily or placebo added to androgen deprivation. Previous treatment for localised disease and previous docetaxel were allowed. Median age was 68; 16.4 percent had had prostatectomy or radiotherapy for localised disease and 10.7 percent previous docetaxel; 62.7 percent had high-volume and 37.3 percent low-volume disease. At the first interim analysis, median follow-up 22.7 months, both primary endpoints were met. Grade 3 or 4 adverse events occurred in 42.2 percent on apalutamide and 40.8 percent on placebo, with rash more common on apalutamide (New England Journal of Medicine 2019).","In England NICE TA741 recommends apalutamide with androgen deprivation for hormone-sensitive metastatic prostate cancer only if docetaxel is not suitable. NICE TA1109 makes the same restriction for darolutamide with androgen deprivation and instructs prescribers to use the least expensive of the suitable options, which includes apalutamide, taking account of administration costs, dosages, price per dose and commercial arrangements."],"nct":"NCT02489318","phase":"3","setting":"A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","sponsor":"Aragon Pharmaceuticals, Inc.","result":"Radiographic progression-free survival at 24 months 68.2 percent with apalutamide added to androgen deprivation against 47.5 percent with placebo (hazard ratio 0.48, 95 percent confidence interval 0.39 to 0.60) and overall survival at 24 months 82.4 against 73.5 percent (0.67, 0.51 to 0.89).","started":"2015-11-27","startedType":"actual","yearReported":2019,"enrolled":1052,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic progression-free survival at 24 months","primary":true,"unit":"%","arms":[{"name":"Apalutamide with androgen deprivation","n":525,"value":68.2},{"name":"Placebo with androgen deprivation","n":527,"value":47.5}],"hr":0.48,"ci":[0.39,0.6],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1903307"},{"endpoint":"Overall survival at 24 months","primary":true,"unit":"%","arms":[{"name":"Apalutamide with androgen deprivation","n":525,"value":82.4},{"name":"Placebo with androgen deprivation","n":527,"value":73.5}],"hr":0.67,"ci":[0.51,0.89],"p":"0.005","source":"https://doi.org/10.1056/NEJMoa1903307"}],"replication":"ARCHES and ENZAMET found the same for enzalutamide, LATITUDE and the STAMPEDE abiraterone comparison for abiraterone, and ARANOTE for darolutamide."},{"id":"nct04325828","kind":"trial","name":"A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma","aka":["YATAGARASU"],"tldr":"A phase 2 trial of Apalutamide in salivary gland cancers, run by Janssen Pharmaceutical K.K., active and no longer recruiting.","summary":"A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma is a phase 2 interventional study registered as NCT04325828 by Janssen Pharmaceutical K.K., with 31 participants enrolled, started 2020-04-07 and due to reach its primary completion in 2021-06-09. Interventions recorded: Apalutamide and GnRH Agonist. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04325828","url":"https://clinicaltrials.gov/study/NCT04325828"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["salivary-gland","salivary-duct-carcinoma"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["apalutamide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04325828","phase":"2","setting":"An Open-label Phase 2 Study to Evaluate the Efficacy and Safety of Apalutamide in Combination With Gonadotropin-releasing Hormone (GnRH) Agonist in Subjects With Locally Advanced or Recurrent/Metastatic and Androgen Receptor (AR) Expressing Salivary Gland Carcinoma","sponsor":"Janssen Pharmaceutical K.K.","started":"2020-04-07","startedType":"actual","yearReported":2022,"enrolled":31,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Apalutamide + Goserelin","n":24,"value":25,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-07-06), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04325828?tab=results"}]},{"id":"nct03767244","kind":"trial","name":"A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy","aka":["PROTEUS"],"tldr":"A phase 3 trial of Apalutamide in prostate cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy is a phase 3 interventional study registered as NCT03767244 by Janssen Research & Development, LLC, with 2517 participants enrolled, started 2019-06-11 and due to reach its primary completion in 2026-12-01. Interventions recorded: Apalutamide, Androgen Deprivation Therapy (ADT) and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03767244","url":"https://clinicaltrials.gov/study/NCT03767244"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["apalutamide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03767244-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03767244","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy","sponsor":"Janssen Research & Development, LLC","started":"2019-06-11","startedType":"actual","enrolled":2517,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03611868","kind":"trial","name":"A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in melanoma and uveal melanoma, run by Ascentage Pharma Group Inc., active and no longer recruiting.","summary":"A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT03611868 by Ascentage Pharma Group Inc., with 230 participants planned, started 2018-08-29 and due to reach its primary completion in 2025-12-30. Interventions recorded: Phase 1b: APG-115+pembrolizumab. Conditions listed: Unresectable or Metastatic Melanoma or Advanced Solid Tumors, Melanoma, Uveal Melanoma, P53 Mutation. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03611868","url":"https://clinicaltrials.gov/study/NCT03611868"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","uveal-melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["ascentage-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03611868","phase":"1/2","setting":"A Phase Ib/II Study of APG-115 as a Monotherapy or in Combination With Pembrolizumab in Patients With Unresectable or Metastatic Melanomas or Advanced Solid Tumors","sponsor":"Ascentage Pharma Group Inc.","started":"2018-08-29","startedType":"actual","enrolled":230,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00229203","kind":"trial","name":"A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 2 trial of Plitidepsin in Multiple myeloma, run by PharmaMar, completed.","summary":"A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT00229203 by PharmaMar, with 51 participants recorded, started 2005-02 and reaching its primary completion in 2008-08. Interventions recorded: Plitidepsin. Conditions recorded: Multiple Myeloma.\n\nLinked to the drug Plitidepsin because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00229203","url":"https://clinicaltrials.gov/study/NCT00229203"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["plitidepsin"],"companies":["pharmamar"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00229203","phase":"2","setting":"\"Phase II Multicenter, Open-Label, Clinical and Pharmacokinetic Study of Aplidin® As A 3-Hour Infusion Every 2 Weeks Alone or in Combination With Dexamethasone, in Pre-Treated Patients With Relapsing or Refractory Multiple Myeloma.\"","sponsor":"PharmaMar","started":"2005-02","yearReported":2009,"enrolled":51,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Plitidepsin","n":21,"value":2.3,"note":"range 1.4 to 2.6; Figures from the ClinicalTrials.gov results section (first posted 2009-12-14), not from a publication"},{"name":"Plitidepsin + Dexamethasone","n":8,"value":3.8,"note":"range 3.1 to 7.7"}],"source":"https://clinicaltrials.gov/study/NCT00229203?tab=results"}]},{"id":"nct04657068","kind":"trial","name":"A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Gemcitabine, FOLFIRI, Irinotecan in metastatic cancer and ovarian cancer, run by Artios Pharma Ltd, now recruiting.","summary":"A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT04657068 by Artios Pharma Ltd, with 542 participants planned, started 2021-01-27 and due to reach its primary completion in 2028-01. Interventions recorded: ART0380, Gemcitabine, Irinotecan. Conditions listed: Advanced Cancer, Metastatic Cancer, Ovarian Cancer, Primary Peritoneal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04657068","url":"https://clinicaltrials.gov/study/NCT04657068"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","ovarian","endometrial","colorectal","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["gemcitabine","folfiri","irinotecan"],"companies":["artios-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04657068","phase":"1/2","setting":"A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors","sponsor":"Artios Pharma Ltd","started":"2021-01-27","startedType":"actual","enrolled":542,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05067140","kind":"trial","name":"A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer","aka":[],"tldr":"A phase 1/2 trial of Abiraterone acetate, Prednisone in prostate cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer is a phase 1/2 interventional study registered as NCT05067140 by Novartis Pharmaceuticals, with 164 participants enrolled, started 2021-09-02 and due to reach its primary completion in 2027-05-25. Interventions recorded: ARV-766, Abiraterone, Corticosteroid (e.g., prednisone/prednisolone), Androgen Deprivation Therapy (ADT). Conditions listed: Prostate Cancer Metastatic. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05067140","url":"https://clinicaltrials.gov/study/NCT05067140"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["abiraterone","prednisone"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05067140","phase":"1/2","setting":"A Phase 1/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 Monotherapy and in Combination With Abiraterone in Patients With Metastatic Prostate Cancer","sponsor":"Novartis Pharmaceuticals","started":"2021-09-02","startedType":"actual","enrolled":164,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05867420","kind":"trial","name":"A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.","aka":[],"tldr":"A phase 1/2 trial of Bevacizumab, Fruquintinib and Docetaxel in advanced solid tumours, run by AskGene Pharma, Inc., now recruiting.","summary":"A Study of ASKG915 in Patients With Selected Advanced Solid Tumors. is a phase 1/2 interventional study registered as NCT05867420 by AskGene Pharma, Inc., with 594 participants planned, started 2023-08-02 and due to reach its primary completion in 2026-12-31. Interventions recorded: ASKG915, Paclitaxel + Bevacizumab, Fruquintinib and Docetaxel.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05867420","url":"https://clinicaltrials.gov/study/NCT05867420"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab","fruquintinib","docetaxel"],"companies":["askgene-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05867420","phase":"1/2","setting":"A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 in Patients With Selected Advanced Solid Tumors","sponsor":"AskGene Pharma, Inc.","started":"2023-08-02","startedType":"actual","enrolled":594,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06699212","kind":"trial","name":"A Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab in First-line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of ","aka":[],"tldr":"A phase 3 trial of Cetuximab sarotalocan, Pembrolizumab, Carboplatin in head and neck squamous cell carcinoma, run by Rakuten Medical, Inc., now recruiting.","summary":"A Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab in First-line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck With No Distant Metastases is a phase 3 interventional study registered as NCT06699212 by Rakuten Medical, Inc., with 412 participants planned, started 2024-12-24 and due to reach its primary completion in 2028-09. Interventions recorded: ASP-1929 Photoimmunotherapy, Pembrolizumab, Carboplatin, Cisplatin, 5-fluorouracil. Conditions listed: Recurrent Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06699212","url":"https://clinicaltrials.gov/study/NCT06699212"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cetuximab-sarotalocan","pembrolizumab","carboplatin","cisplatin","paclitaxel","docetaxel"],"companies":["rakuten-medical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06699212","phase":"3","setting":"A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients With Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) With No Distant Metastases","sponsor":"Rakuten Medical, Inc.","started":"2024-12-24","startedType":"actual","enrolled":412,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07673887","kind":"trial","name":"A Study of ASP2138 Together With Chemotherapy and Pembrolizumab in Adults With Gastric Cancer","aka":[],"tldr":"A phase 3 trial testing ASP2138 in gastric & gastro-oesophageal junction cancer, now recruiting.","summary":"A Study of ASP2138 Together With Chemotherapy and Pembrolizumab in Adults With Gastric Cancer is a phase 3 interventional study registered as NCT07673887, led by Astellas Pharma Global Development, and recruiting on the registry. Official title: A Phase 3, Global, Multi-centre, Double-blind, Randomised Study of ASP2138 Plus Chemotherapy (CAPOX or mFOLFOX6) With Pembrolizumab vs Placebo Plus Chemotherapy With or Without Pembrolizumab in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in Participants Whose Tumours Are HER2-negative and Claudin (CLDN) 18.2-positive. Planned enrolment is 570 participants (estimated). The study started in 2026-06-30 and primary completion is expected in 2031-02-28. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07673887","url":"https://clinicaltrials.gov/study/NCT07673887"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":[],"targets":[],"drugs":["asp2138"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07673887","phase":"3","setting":"A Phase 3, Global, Multi-center, Double-blind, Randomized Study of ASP2138 Plus Chemotherapy (CAPOX or mFOLFOX6) With Pembrolizumab vs Placebo Plus Chemotherapy With or Without Pembrolizumab in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in Participants Whose Tumors Are HER2-negative and Claudin (CLDN) 18.2-positive","sponsor":"Astellas Pharma Global Development","started":"2026-06-30","startedType":"actual","enrolled":570,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03182244","kind":"trial","name":"A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation","aka":[],"tldr":"A phase 3 trial of Gilteritinib, Cytarabine, Mitoxantrone, Etoposide and Fludarabine in acute myeloid leukaemia, run by Astellas Pharma Inc, now completed.","summary":"A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation is a phase 3 interventional study registered as NCT03182244 by Astellas Pharma Inc, with 276 participants enrolled, started 2017-10-25 and reached its primary completion in 2023-12-25. Interventions recorded: Gilteritinib, Cytarabine, Mitoxantrone, Etoposide, G-CSF and Fludarabine. Results have been posted on the registry.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03182244","url":"https://clinicaltrials.gov/study/NCT03182244"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-flt3"],"sections":[],"technologies":[],"targets":[],"drugs":["gilteritinib","cytarabine","mitoxantrone","etoposide","fludarabine"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registry status on 22 September 2026: Completed (registry record last updated 22 September 2026; primary completion reached 25 December 2023)."],"nct":"NCT03182244","phase":"3","setting":"Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation","sponsor":"Astellas Pharma Inc","started":"2017-10-25","startedType":"actual","yearReported":2025,"enrolled":276,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Gilteritinib","n":137,"value":10.3,"note":"95% CI 8.8 to 12.7; Figures from the ClinicalTrials.gov results section (first posted 2025-01-14), not from a publication"},{"name":"Salvage Chemotherapy","n":139,"value":5.4,"note":"95% CI 4.1 to 8.1"}],"hr":0.612,"ci":[0.451,0.832],"p":"0.00152","source":"https://clinicaltrials.gov/study/NCT03182244?tab=results"}]},{"id":"nct07287995","kind":"trial","name":"A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab, Enfortumab vedotin and Carboplatin in advanced solid tumours, run by Astellas Pharma Global Development, Inc., now recruiting.","summary":"A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors is a phase 1/2 interventional study registered as NCT07287995 by Astellas Pharma Global Development, Inc., with 428 participants planned, started 2026-02-05 and due to reach its primary completion in 2029-06-30. Interventions recorded: ASP2998, Pembrolizumab, Enfortumab Vedotin and Carboplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07287995","url":"https://clinicaltrials.gov/study/NCT07287995"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","enfortumab-vedotin","carboplatin"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07287995","phase":"1/2","setting":"A Phase 1b/2 Study of ASP2998 as Monotherapy and in Combination With Standard Therapies in Participants With Locally Advanced Unresectable or Metastatic Solid Tumors","sponsor":"Astellas Pharma Global Development, Inc.","started":"2026-02-05","startedType":"actual","enrolled":428,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07730021","kind":"trial","name":"A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab, Carboplatin and Oxaliplatin in advanced solid tumours, run by Astellas Pharma Global Development, Inc., now recruiting.","summary":"A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors is a phase 1/2 interventional study registered as NCT07730021 by Astellas Pharma Global Development, Inc., with 392 participants planned, started 2026-09-02 and due to reach its primary completion in 2030-02-28. Interventions recorded: ASP388B, Pembrolizumab, Carboplatin, Oxaliplatin and 5-fluorouracil.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07730021","url":"https://clinicaltrials.gov/study/NCT07730021"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","carboplatin","oxaliplatin"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07730021","phase":"1/2","setting":"A Phase 1b/2 Study of ASP388B as Monotherapy and in Combination With Standard Therapies in Participants With Locally Advanced Unresectable or Metastatic Solid Tumors","sponsor":"Astellas Pharma Global Development, Inc.","started":"2026-09-02","startedType":"actual","enrolled":392,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07488676","kind":"trial","name":"A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ASP546C in gastric & gastro-oesophageal junction cancer and pancreatic ductal adenocarcinoma, run by Astellas Pharma Global Development, Inc., now recruiting.","summary":"A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors is a phase 1/2 interventional study registered as NCT07488676 by Astellas Pharma Global Development, Inc., with 150 participants planned, started 2026-05-04 and due to reach its primary completion in 2029-07-31. Interventions recorded: ASP546C.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07488676","url":"https://clinicaltrials.gov/study/NCT07488676"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","pancreatic","gastric-cldn18-2-positive","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07488676","phase":"1/2","setting":"A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants With CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid Tumor Types","sponsor":"Astellas Pharma Global Development, Inc.","started":"2026-05-04","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05047250","kind":"trial","name":"A Study of Atezolizumab in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of Atezolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study of Atezolizumab in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT05047250 by Hoffmann-La Roche, with 60 participants enrolled, started 2022-06-14 and due to reach its primary completion in 2025-12-30. Interventions recorded: Atezolizumab. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05047250","url":"https://clinicaltrials.gov/study/NCT05047250"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05047250","phase":"3","setting":"A Phase III, Single-Arm Multicenter Study of Atezolizumab (Anti-PD-L1 Antibody) in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer","sponsor":"Hoffmann-La Roche","started":"2022-06-14","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05009069","kind":"trial","name":"A Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Participants With Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of Capecitabine, Fluorouracil, Atezolizumab in colorectal cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Participants With Locally Advanced Rectal Cancer is a phase 2 interventional study registered as NCT05009069 by Hoffmann-La Roche, with 58 participants enrolled, started 2022-03-18 and due to reach its primary completion in 2023-11-21. Interventions recorded: Radiotherapy, Capecitabine, Fluorouracil, Atezolizumab, Tiragolumab. Conditions listed: Rectal Neoplasms, Rectal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05009069","url":"https://clinicaltrials.gov/study/NCT05009069"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","tigit-blockade"],"targets":[],"drugs":["capecitabine","fluorouracil","atezolizumab","tiragolumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05009069","phase":"2","setting":"A Phase II, Randomized, Open Label, Parallel-group Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer","sponsor":"Hoffmann-La Roche","started":"2022-03-18","startedType":"actual","enrolled":58,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06977737","kind":"trial","name":"A Study of ATTR-01 in Participants With Select Epithelial Solid Tumours","aka":["ATTEST"],"tldr":"A phase 1/2 trial of ATTR-01 in advanced solid tumours, run by Accession Therapeutics Limited, now recruiting.","summary":"A Study of ATTR-01 in Participants With Select Epithelial Solid Tumours is a phase 1/2 interventional study registered as NCT06977737 by Accession Therapeutics Limited, with 72 participants planned, started 2025-03-21 and due to reach its primary completion in 2029-12-31. Interventions recorded: ATTR-01.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06977737","url":"https://clinicaltrials.gov/study/NCT06977737"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06977737","phase":"1/2","setting":"A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants With Select Epithelial Solid Tumours Under Multiple Sub-protocols","sponsor":"Accession Therapeutics Limited","started":"2025-03-21","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06072781","kind":"trial","name":"A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer","aka":["RAMP 301"],"tldr":"A phase 3 trial of Pegylated liposomal doxorubicin, Paclitaxel / nab-paclitaxel, Letrozole in ovarian cancer, run by Verastem, Inc., now recruiting.","summary":"A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer is a phase 3 interventional study registered as NCT06072781 by Verastem, Inc., with 270 participants planned, started 2024-03-18 and due to reach its primary completion in 2028-10-15. Interventions recorded: avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole. Conditions listed: Low Grade Serous Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06072781","url":"https://clinicaltrials.gov/study/NCT06072781"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","low-grade-serous-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pegylated-liposomal-doxorubicin","paclitaxel","letrozole"],"companies":["verastem"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06072781","phase":"3","setting":"A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)","sponsor":"Verastem, Inc.","started":"2024-03-18","startedType":"actual","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06682572","kind":"trial","name":"A Study of Avutometinib + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer in Japanese Patients","aka":["RAMP201J"],"tldr":"A phase 2 trial of Avutometinib (VS-6766) + Defactinib (VS-6063) in ovarian cancer, run by Verastem, Inc., active and no longer recruiting.","summary":"A Study of Avutometinib + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer in Japanese Patients is a phase 2 interventional study registered as NCT06682572 by Verastem, Inc., with 16 participants enrolled, started 2024-10-30 and due to reach its primary completion in 2025-12. Interventions recorded: Avutometinib (VS-6766) + Defactinib (VS-6063).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06682572","url":"https://clinicaltrials.gov/study/NCT06682572"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","low-grade-serous-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["verastem"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06682572","phase":"2","setting":"A Phase 2 Study of Avutometinib (VS-6766, a Dual RAF/MEK Inhibitor) In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) in Japanese Patients","sponsor":"Verastem, Inc.","started":"2024-10-30","startedType":"actual","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06564038","kind":"trial","name":"A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies","aka":["Soundtrack-E"],"tldr":"A phase 1/2 trial of AZD0486, Prednisone, Rituximab in chronic lymphocytic leukaemia and mantle cell lymphoma, run by AstraZeneca, now recruiting.","summary":"A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies is a phase 1/2 interventional study registered as NCT06564038 by AstraZeneca, with 408 participants planned, started 2025-01-30 and due to reach its primary completion in 2029-06-11. Interventions recorded: Surovatamig, Prednisone (or equivalent), Rituximab, Cyclophosphamide, Vincristine. Conditions listed: Chronic Lymphocytic Leukaemia, Small Lymphocytic Lymphoma, Mantle-cell Lymphoma, Large B-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06564038","url":"https://clinicaltrials.gov/study/NCT06564038"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cll","mantle-cell-lymphoma","hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["azd0486","prednisone","rituximab","cyclophosphamide","vincristine","doxorubicin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06564038","phase":"1/2","setting":"A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies","sponsor":"AstraZeneca","started":"2025-01-30","startedType":"actual","enrolled":408,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04995523","kind":"trial","name":"A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC","aka":["ARTEMIDE-01"],"tldr":"A phase 1/2 trial of Rilvegostomig in non-small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC is a phase 1/2 interventional study registered as NCT04995523 by AstraZeneca, with 212 participants enrolled, started 2021-09-14 and due to reach its primary completion in 2026-08-28. Interventions recorded: AZD2936.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04995523","url":"https://clinicaltrials.gov/study/NCT04995523"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["rilvegostomig"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04995523","phase":"1/2","setting":"Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC","sponsor":"AstraZeneca","started":"2021-09-14","startedType":"actual","enrolled":212,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06130553","kind":"trial","name":"A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors","aka":["PRIMROSE"],"tldr":"A phase 1/2 trial of AZD3470 and Datopotamab deruxtecan in advanced solid tumours, run by AstraZeneca, now recruiting.","summary":"A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06130553 by AstraZeneca, with 334 participants planned, started 2024-01-18 and due to reach its primary completion in 2028-12-04. Interventions recorded: AZD3470 and Datopotamab deruxtecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06130553","url":"https://clinicaltrials.gov/study/NCT06130553"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["azd3470","datopotamab-deruxtecan"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06130553","phase":"1/2","setting":"PRIMROSE: A Modular Phase I/IIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced/Metastatic Solid Tumors That Are MTAP Deficient","sponsor":"AstraZeneca","started":"2024-01-18","startedType":"actual","enrolled":334,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05128825","kind":"trial","name":"A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer","aka":["DENALI"],"tldr":"A phase 2 trial of Azenosertib in ovarian cancer, run by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc, now recruiting.","summary":"A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer is a phase 2 interventional study registered as NCT05128825 by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc, with 310 participants planned, started 2022-02-17 and due to reach its primary completion in 2026-12-01. Interventions recorded: azenosertib. Conditions listed: High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05128825","url":"https://clinicaltrials.gov/study/NCT05128825"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["azenosertib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05128825","phase":"2","setting":"A Phase 2 Open-Label, Multicenter Study To Evaluate Efficacy And Safety Of ZN-c3 In Subjects With High-Grade Serous Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer (DENALI / ZN-c3-005 / GOG-3066)","sponsor":"K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc","started":"2022-02-17","startedType":"actual","enrolled":310,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07546500","kind":"trial","name":"A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression","aka":["ASPENOVA"],"tldr":"A phase 3 trial testing Azenosertib in ovarian cancer, now recruiting.","summary":"A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression is a phase 3 interventional study registered as NCT07546500, led by K-, Beta with European Network of Gynaecological Oncological Trial Groups (ENGOT) and GOG Foundation, and recruiting on the registry. Official title: A Randomised, Open-Label Phase 3 Study of Azenosertib Versus Investigator's Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression. Planned enrolment is 420 participants (estimated). The study started in 2026-04-17 and primary completion is expected in 2028-05-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07546500","url":"https://clinicaltrials.gov/study/NCT07546500"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["azenosertib"],"companies":["zentalis-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07546500","phase":"3","setting":"A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigator's Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression","sponsor":"K-, Beta","started":"2026-04-17","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06434610","kind":"trial","name":"A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.","aka":[],"tldr":"A phase 2 trial of Paclitaxel / nab-paclitaxel in ovarian cancer, run by Shanghai Jiaolian Drug Research and Development Co., Ltd, now recruiting.","summary":"A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer. is a phase 2 interventional study registered as NCT06434610 by Shanghai Jiaolian Drug Research and Development Co., Ltd, with 90 participants planned, started 2024-07-11 and due to reach its primary completion in 2026-12-31. Interventions recorded: B013, Paclitaxel, Placebo. Conditions listed: Platinum-resistant Recurrent Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06434610","url":"https://clinicaltrials.gov/study/NCT06434610"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06434610","phase":"2","setting":"A Multicenter, Randomized, Double-blind, Parallel-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of B013 Combined With Paclitaxel in the Treatment of Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer.","sponsor":"Shanghai Jiaolian Drug Research and Development Co., Ltd","started":"2024-07-11","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07544056","kind":"trial","name":"A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 2/3 trial testing BEBT-209 in triple-negative breast cancer, now recruiting.","summary":"A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer is a phase 2/3 interventional study registered as NCT07544056, led by BeBetter Med with Hunan Cancer Hospital and Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, and recruiting on the registry. Official title: A Randomised, Controlled, Open-label, Multi-centre, Phase IIb/III Clinical Study to Evaluate BEBT-209 Plus Carboplatin and Gemcitabine Versus Carboplatin Plus Gemcitabine in Locally Advanced or Metastatic Triple-Negative Breast Cancer. Planned enrolment is 446 participants (estimated). The study started in 2026-06-04 and primary completion is expected in 2030-06. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07544056","url":"https://clinicaltrials.gov/study/NCT07544056"}],"tags":["ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["bebt-209"],"companies":["bebetter-med"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07544056","phase":"2/3","setting":"A Randomized, Controlled, Open-label, Multi-center, Phase IIb/III Clinical Study to Evaluate BEBT-209 Plus Carboplatin and Gemcitabine Versus Carboplatin Plus Gemcitabine in Locally Advanced or Metastatic Triple-Negative Breast Cancer","sponsor":"BeBetter Med","started":"2026-06-04","startedType":"actual","enrolled":446,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06679101","kind":"trial","name":"A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethas","aka":["DREAMM-10"],"tldr":"A phase 3 trial of Belantamab mafodotin, Lenalidomide, Dexamethasone in multiple myeloma, run by GlaxoSmithKline, now recruiting.","summary":"A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM) is a phase 3 interventional study registered as NCT06679101 by GlaxoSmithKline, with 520 participants planned, started 2024-12-16 and due to reach its primary completion in 2031-04-28. Interventions recorded: Belantamab mafodotin, Lenalidomide, Dexamethasone, Daratumumab. Conditions listed: Multiple Myeloma, Newly Diagnosed Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06679101","url":"https://clinicaltrials.gov/study/NCT06679101"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-transplant-ineligible"],"sections":[],"technologies":["adc","antiemetic-therapy","monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["belantamab-mafodotin","lenalidomide","dexamethasone","daratumumab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06679101","phase":"3","setting":"A Phase 3, Randomized, Open-label Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)","sponsor":"GlaxoSmithKline","started":"2024-12-16","startedType":"actual","enrolled":520,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06472076","kind":"trial","name":"A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)","aka":["GALAXIES Lung-301"],"tldr":"A phase 3 trial of Dostarlimab and Pembrolizumab in non-small-cell lung cancer, run by GlaxoSmithKline, active and no longer recruiting.","summary":"A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC) is a phase 3 interventional study registered as NCT06472076 by GlaxoSmithKline, with 88 participants enrolled, started 2024-06-10 and due to reach its primary completion in 2026-06-30. Interventions recorded: Dostarlimab, Belrestotug, Pembrolizumab and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06472076","url":"https://clinicaltrials.gov/study/NCT06472076"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab","pembrolizumab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06472076","phase":"3","setting":"A Randomized, Multicenter, Double-blind, Phase 3 Study to Investigate the Safety and Efficacy of Belrestotug in Combination With Dostarlimab Compared With Placebo in Combination With Pembrolizumab in Participants With Previously Untreated, Unresectable, Locally Advanced or Metastatic PD-L1 Selected Non-small Cell Lung Cancer (GALAXIES Lung-301)","sponsor":"GlaxoSmithKline","started":"2024-06-10","startedType":"actual","enrolled":88,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05468697","kind":"trial","name":"A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6","aka":[],"tldr":"A phase 1/2 trial of Belzutifan, Palbociclib in renal cell carcinoma, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024) is a phase 1/2 interventional study registered as NCT05468697 by Merck Sharp & Dohme LLC, with 60 participants planned, started 2022-08-10 and due to reach its primary completion in 2026-10-22. Interventions recorded: Belzutifan, Palbociclib. Conditions listed: Renal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05468697","url":"https://clinicaltrials.gov/study/NCT05468697"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":["cdk46-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["belzutifan","palbociclib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05468697","phase":"1/2","setting":"A Multicenter, Open-label, Randomized, Phase 1/2 Study of Belzutifan in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma","sponsor":"Merck Sharp & Dohme LLC","started":"2022-08-10","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04489771","kind":"trial","name":"A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)","aka":[],"tldr":"A phase 2 trial of Belzutifan in renal cell carcinoma, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013) is a phase 2 interventional study registered as NCT04489771 by Merck Sharp & Dohme LLC, with 154 participants enrolled, started 2020-09-13 and due to reach its primary completion in 2023-02-10. Interventions recorded: Belzutifan. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04489771","url":"https://clinicaltrials.gov/study/NCT04489771"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["belzutifan"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04489771","phase":"2","setting":"Phase 2 Study of MK-6482 in Participants With Advanced Renal Cell Carcinoma","sponsor":"Merck Sharp & Dohme LLC","started":"2020-09-13","startedType":"actual","yearReported":2024,"enrolled":154,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)","primary":true,"unit":"%","arms":[{"name":"Belzutifan 200 mg","n":78,"value":23.1,"note":"95% CI 14.3 to 34.0; Figures from the ClinicalTrials.gov results section (first posted 2024-02-28), not from a publication"},{"name":"Belzutifan 120 mg","n":76,"value":23.7,"note":"95% CI 14.7 to 34.8"}],"p":"0.5312","source":"https://clinicaltrials.gov/study/NCT04489771?tab=results"}]},{"id":"nct03729245","kind":"trial","name":"A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)","aka":[],"tldr":"A phase 3 trial of Bempegaldesleukin, Sunitinib, Nivolumab and Cabozantinib in Renal cell carcinoma, run by Nektar Therapeutics, recorded as terminated on the registry.","summary":"A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC) is a phase 3 interventional study registered as NCT03729245 by Nektar Therapeutics, with 623 participants recorded, started 2018-12-18 and due to reach its primary completion in 2022-01-07. Interventions recorded: bempegaldesleukin, sunitinib, nivolumab, cabozantinib. Conditions recorded: Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma.\n\nLinked to the drug Bempegaldesleukin because the registry names it among its interventions and Renal cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03729245","url":"https://clinicaltrials.gov/study/NCT03729245"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["bempegaldesleukin","sunitinib","nivolumab","cabozantinib"],"companies":["nektar-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03729245","phase":"3","setting":"A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma","sponsor":"Nektar Therapeutics","started":"2018-12-18","startedType":"actual","enrolled":623,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07538271","kind":"trial","name":"A Study of Benmelstobart, Anlotinib, Chemotherapy and Thoracic Radiotherapy for People With Extensive-stage Small Cell Lung Cancer","aka":["Aurora 005"],"tldr":"A phase 2 trial of benmelstobart, anlotinib and etoposide in lung cancer, run by Yayi He, not yet recruiting.","summary":"A Study of Benmelstobart, Anlotinib, Chemotherapy and Thoracic Radiotherapy for People With Extensive-stage Small Cell Lung Cancer is a phase 2, interventional study registered as NCT07538271 by Yayi He, with a registry enrolment figure of 33 participants, started 2026-04-20 and due to reach its primary completion in 2027-09-30. Interventions recorded: benmelstobart; Anlotinib; Carboplatin or cisplatin; Etoposide; Thoracic Radiotherapy. Conditions listed: SCLC, Extensive Stage. Primary outcome: Objective Response Rate (ORR). Lung eligibility wording from the registry: \"* 1: Histologically or cytologically confirmed inoperable extensive-stage small cell lung cancer (ES-SCLC) according to the VALG staging system\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07538271","url":"https://clinicaltrials.gov/study/NCT07538271"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","kinase-inhibitors","topoisomerase-inhibitors"],"targets":[],"drugs":["benmelstobart","anlotinib","etoposide"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07538271","phase":"2","setting":"A Single-arm, Exploratory Clinical Study of Benmelstobart Combined With Anlotinib and Chemotherapy Followed by Thoracic Radiotherapy as First-line Treatment for Extensive-stage Small Cell Lung Cancer (ES-SCLC)","sponsor":"Yayi He","started":"2026-04-20","startedType":"estimated","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04762069","kind":"trial","name":"A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme","aka":[],"tldr":"A phase 2 trial of Berubicin in glioma & glioblastoma, run by CNS Pharmaceuticals, Inc., active and no longer recruiting.","summary":"A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme is a phase 2 interventional study registered as NCT04762069 by CNS Pharmaceuticals, Inc., with 252 participants enrolled, started 2021-05-18 and due to reach its primary completion in 2026-04-27. Interventions recorded: Berubicin and Lomustine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04762069","url":"https://clinicaltrials.gov/study/NCT04762069"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["lomustine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04762069","phase":"2","setting":"A Multicenter, Open-Label Study With a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme After Failure of Standard First Line Therapy","sponsor":"CNS Pharmaceuticals, Inc.","started":"2021-05-18","startedType":"actual","enrolled":252,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04771130","kind":"trial","name":"A Study of BGB-11417 in Participants With Myeloid Malignancies","aka":[],"tldr":"A phase 1/2 trial of Sonrotoclax and Azacitidine in acute myeloid leukaemia and myelodysplastic syndromes / neoplasms, run by BeOne Medicines, now recruiting.","summary":"A Study of BGB-11417 in Participants With Myeloid Malignancies is a phase 1/2 interventional study registered as NCT04771130 by BeOne Medicines, with 260 participants planned, started 2021-05-24 and due to reach its primary completion in 2028-08-31. Interventions recorded: BGB-11417, Azacitidine and Posaconazole.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04771130","url":"https://clinicaltrials.gov/study/NCT04771130"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","mds"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["sonrotoclax","azacitidine"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04771130","phase":"1/2","setting":"A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies","sponsor":"BeOne Medicines","started":"2021-05-24","startedType":"actual","enrolled":260,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06970743","kind":"trial","name":"A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors","aka":["CaDAnCe-303"],"tldr":"A phase 3 trial of BGB-16673, Bendamustine, Rituximab, Chlorambucil and Obinutuzumab in chronic lymphocytic leukaemia, run by BeOne Medicines, active and no longer recruiting.","summary":"A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors is a phase 3 interventional study registered as NCT06970743 by BeOne Medicines, with 153 participants enrolled, started 2025-05-29 and due to reach its primary completion in 2029-11-30. Interventions recorded: BGB-16673, Bendamustine, Rituximab, Methylprednisolone, Chlorambucil and Obinutuzumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06970743","url":"https://clinicaltrials.gov/study/NCT06970743"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["protac-degrader"],"targets":[],"drugs":["bgb-16673","bendamustine","rituximab","chlorambucil","obinutuzumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06970743","phase":"3","setting":"A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent BTK Inhibitors","sponsor":"BeOne Medicines","started":"2025-05-29","startedType":"actual","enrolled":153,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06706076","kind":"trial","name":"A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations","aka":["SOLARA"],"tldr":"A phase 1/2 trial of Carboplatin, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by BlossomHill Therapeutics, now recruiting.","summary":"A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations is a phase 1/2 interventional study registered as NCT06706076 by BlossomHill Therapeutics, with 675 participants planned, started 2025-01-09 and due to reach its primary completion in 2029-01-31. Interventions recorded: BH-30643, BH-30643 combo therapy with Carboplatin/Pemetrexed, BH-30643. Conditions listed: NSCLC (Advanced Non-small Cell Lung Cancer). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06706076","url":"https://clinicaltrials.gov/study/NCT06706076"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc","her2-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["carboplatin","pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06706076","phase":"1/2","setting":"A Phase 1/2 Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Adult Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations (SOLARA)","sponsor":"BlossomHill Therapeutics","started":"2025-01-09","startedType":"actual","enrolled":675,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04219254","kind":"trial","name":"A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of BI1206 in advanced solid tumours, run by BioInvent International AB, now recruiting.","summary":"A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT04219254 by BioInvent International AB, with 197 participants planned, started 2020-06-29 and due to reach its primary completion in 2027-11. Interventions recorded: BI1206.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04219254","url":"https://clinicaltrials.gov/study/NCT04219254"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bioinvent-international","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04219254","phase":"1/2","setting":"A Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors","sponsor":"BioInvent International AB","started":"2020-06-29","startedType":"actual","enrolled":197,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03526835","kind":"trial","name":"A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Petosemtamab, Pembrolizumab, FOLFIRI in colorectal cancer and head and neck squamous cell carcinoma, run by Merus B.V., now recruiting.","summary":"A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT03526835 by Merus B.V., with 560 participants planned, started 2018-05-02 and due to reach its primary completion in 2028-05. Interventions recorded: MCLA-158, MCLA-158 + Pembrolizumab, MCLA-158 + FOLFIRI, MCLA-158 + FOLFOX. Conditions listed: Advanced/Metastatic Solid Tumors, Colorectal Cancer, Gastric Cancer, Gastroesophageal-junction Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03526835","url":"https://clinicaltrials.gov/study/NCT03526835"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","head-and-neck"],"sections":[],"technologies":["bispecific-antibody"],"targets":[],"drugs":["petosemtamab","pembrolizumab","folfiri","folfox"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03526835","phase":"1/2","setting":"Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors","sponsor":"Merus B.V.","started":"2018-05-02","startedType":"actual","enrolled":560,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06405425","kind":"trial","name":"A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma","aka":[],"tldr":"A phase 2 trial of BL-B01D1 in bladder & urothelial cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma is a phase 2 interventional study registered as NCT06405425 by Sichuan Baili Pharmaceutical Co., Ltd., with 52 participants planned, started 2024-05-29 and due to reach its primary completion in 2026-12. Interventions recorded: BL-B01D1 and PD-1.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06405425","url":"https://clinicaltrials.gov/study/NCT06405425"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06405425","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 + PD-1 Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-05-29","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07054567","kind":"trial","name":"A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer","aka":[],"tldr":"A phase 2 trial of Izalontamab brengitecan, Pembrolizumab, Bevacizumab in cervical cancer and endometrial cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer is a phase 2 interventional study registered as NCT07054567 by Sichuan Baili Pharmaceutical Co., Ltd., with 96 participants planned, started 2025-08-21 and due to reach its primary completion in 2027-05. Interventions recorded: BL-B01D1, Pembrolizumab, Bevacizumab. Conditions listed: Cervical Cancer, Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07054567","url":"https://clinicaltrials.gov/study/NCT07054567"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","endometrial","recurrent-metastatic-cervical-cancer","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["izalontamab-brengitecan","pembrolizumab","bevacizumab"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07054567","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 + Pembrolizumab Dual Therapy With or Without Bevacizumab (BL-B01D1 + Pembrolizumab ± Bevacizumab) in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2025-08-21","startedType":"actual","enrolled":96,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05880706","kind":"trial","name":"A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung ","aka":[],"tldr":"A phase 2 trial of Izalontamab brengitecan, Osimertinib in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT05880706 by Sichuan Baili Pharmaceutical Co., Ltd., with 198 participants enrolled, started 2023-07-19 and due to reach its primary completion in 2027-07. Interventions recorded: BL-B01D1, Osimertinib Mesylate Tablets. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05880706","url":"https://clinicaltrials.gov/study/NCT05880706"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["izalontamab-brengitecan","osimertinib"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05880706","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-07-19","startedType":"actual","enrolled":198,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07827261","kind":"trial","name":"A Study of BL-B01D1 Combined With Glecirasib in Patients With KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of izalontamab brengitecan and glecirasib in lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., not yet recruiting.","summary":"A Study of BL-B01D1 Combined With Glecirasib in Patients With KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer is a phase 2, interventional study registered as NCT07827261 by Sichuan Baili Pharmaceutical Co., Ltd., with a registry enrolment figure of 36 participants, started 2026-09 and due to reach its primary completion in 2028-12. Interventions recorded: BL-B01D1; Glecirasib. Conditions listed: Non-small Cell Lung Cancer. Primary outcome: Objective Response Rate (ORR). Lung eligibility wording from the registry: \"Patients with locally advanced or metastatic non-small cell lung cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07827261","url":"https://clinicaltrials.gov/study/NCT07827261"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["kras-g12c-nsclc"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["izalontamab-brengitecan","glecirasib"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07827261","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection Combined With Glecirasib in Patients With KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-09","startedType":"estimated","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07642024","kind":"trial","name":"A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU","aka":["PANKU-Lung09"],"tldr":"A phase 2/3 trial of Izalontamab brengitecan, Osimertinib, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09) is a phase 2/3 interventional study registered as NCT07642024 by Sichuan Baili Pharmaceutical Co., Ltd., with 90 participants planned, started 2026-07-24 and due to reach its primary completion in 2032-12. Interventions recorded: BL-B01D1, Osimertinib, Carboplatin, Pemetrexed, Cisplatin. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07642024","url":"https://clinicaltrials.gov/study/NCT07642024"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["izalontamab-brengitecan","osimertinib","carboplatin","pemetrexed","cisplatin"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07642024","phase":"2/3","setting":"A Phase II/III Randomized Controlled Clinical Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-07-24","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06498986","kind":"trial","name":"A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Izalontamab brengitecan, Osimertinib in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT06498986 by Sichuan Baili Pharmaceutical Co., Ltd., with 40 participants planned, started 2024-07-31 and due to reach its primary completion in 2026-08. Interventions recorded: BL-B01D1, Osimertinib Mesylate Tablets. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06498986","url":"https://clinicaltrials.gov/study/NCT06498986"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["izalontamab-brengitecan","osimertinib"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06498986","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-07-31","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06838273","kind":"trial","name":"A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metas","aka":[],"tldr":"A phase 3 trial of Izalontamab brengitecan, Osimertinib in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer(PANKU-Lung04) is a phase 3 interventional study registered as NCT06838273 by Sichuan Baili Pharmaceutical Co., Ltd., with 720 participants planned, started 2025-02-24 and due to reach its primary completion in 2028-12. Interventions recorded: BL-B01D1, Osimertinib, Osimertinib. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06838273","url":"https://clinicaltrials.gov/study/NCT06838273"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["izalontamab-brengitecan","osimertinib"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06838273","phase":"3","setting":"A Phase III Randomized Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2025-02-24","startedType":"actual","enrolled":720,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07554456","kind":"trial","name":"A Study of BL-B01D1 in Combination With Tislelizumab ±5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02)","aka":["PANKU-Esophagus02"],"tldr":"A phase 2/3 trial of Tislelizumab and Cisplatin in oesophageal cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1 in Combination With Tislelizumab ±5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02) is a phase 2/3 interventional study registered as NCT07554456 by Sichuan Baili Pharmaceutical Co., Ltd., with 90 participants planned, started 2026-06-09 and due to reach its primary completion in 2028-12. Interventions recorded: BL-B01D1, Tislelizumab, 5-Fluorouracil, Cisplatin and Paclitaxel.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07554456","url":"https://clinicaltrials.gov/study/NCT07554456"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal","oesophageal-squamous-cell-carcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab","cisplatin"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07554456","phase":"2/3","setting":"A Phase II/III Randomized Controlled Clinical Study of BL-B01D1 for Injection in Combination With Tislelizumab With or Without 5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02)","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-06-09","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06787664","kind":"trial","name":"A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Chordoma","aka":[],"tldr":"A phase 2 trial of Izalontamab brengitecan in chordoma, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Chordoma is a phase 2 interventional study registered as NCT06787664 by Sichuan Baili Pharmaceutical Co., Ltd., with 27 participants enrolled, started 2025-01-16 and due to reach its primary completion in 2027-06. Interventions recorded: BL-B01D1. Conditions listed: Chordoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06787664","url":"https://clinicaltrials.gov/study/NCT06787664"}],"tags":["ctgov-ingest"],"related":[],"cancers":["chordoma"],"sections":[],"technologies":["adc","bispecific-adc"],"targets":[],"drugs":["izalontamab-brengitecan"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06787664","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Patients With Locally Advanced or Metastatic Chordoma","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2025-01-16","startedType":"actual","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05785039","kind":"trial","name":"A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors","aka":[],"tldr":"A phase 2 trial of BL-B01D1 in advanced solid tumours, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors is a phase 2 interventional study registered as NCT05785039 by Sichuan Baili Pharmaceutical Co., Ltd., with 76 participants planned, started 2023-04-20 and due to reach its primary completion in 2026-12. Interventions recorded: BL-B01D1.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05785039","url":"https://clinicaltrials.gov/study/NCT05785039"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05785039","phase":"2","setting":"Phase IIa/IIb Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-B01D1 for Injection in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-04-20","startedType":"actual","enrolled":76,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05803018","kind":"trial","name":"A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies","aka":[],"tldr":"A phase 1/2 trial of BL-B01D1 in advanced solid tumours, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies is a phase 1/2 interventional study registered as NCT05803018 by Sichuan Baili Pharmaceutical Co., Ltd., with 38 participants planned, started 2023-06-25 and due to reach its primary completion in 2026-12. Interventions recorded: BL-B01D1.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05803018","url":"https://clinicaltrials.gov/study/NCT05803018"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05803018","phase":"1/2","setting":"A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-B01D1 for Injection in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-06-25","startedType":"actual","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06598787","kind":"trial","name":"A Study of BL-B01D1 in Patients With Recurrent Glioblastoma","aka":[],"tldr":"A phase 2 trial of BL-B01D1 for Injection in glioma & glioblastoma, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1 in Patients With Recurrent Glioblastoma is a phase 2 interventional study registered as NCT06598787 by Sichuan Baili Pharmaceutical Co., Ltd., with 20 participants planned, started 2024-10-17 and due to reach its primary completion in 2026-10. Interventions recorded: BL-B01D1 for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06598787","url":"https://clinicaltrials.gov/study/NCT06598787"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06598787","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Patients With Recurrent Glioblastoma","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-10-17","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07729956","kind":"trial","name":"A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inopera","aka":["PANKU-Breast04"],"tldr":"A phase 3 trial of izalontamab brengitecan and nab-paclitaxel in triple-negative breast cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., not yet recruiting.","summary":"A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04) is a phase 3, randomised interventional study registered as NCT07729956 by Sichuan Baili Pharmaceutical Co., Ltd., with a registry enrolment figure of 436 participants, started 2026-08 and due to reach its primary completion in 2029-12. Interventions recorded: BL-B01D1; PD-1 monoclonal antibody; Nab-paclitaxel. Conditions listed: Triple-Negative Breast Cancer (TNBC). Triple-negative eligibility wording from the registry: \"Pathologically confirmed recurrent or metastatic triple-negative breast cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07729956","url":"https://clinicaltrials.gov/study/NCT07729956"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy"],"targets":[],"drugs":["izalontamab-brengitecan","nab-paclitaxel"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07729956","phase":"3","setting":"A Phase III Randomized Controlled Clinical Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-08","startedType":"estimated","enrolled":436,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05924841","kind":"trial","name":"A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Extensive Stage Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Izalontamab brengitecan in small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Extensive Stage Small Cell Lung Cancer is a phase 2 interventional study registered as NCT05924841 by Sichuan Baili Pharmaceutical Co., Ltd., with 100 participants planned, started 2023-11-10 and due to reach its primary completion in 2026-12. Interventions recorded: BL-B01D1, SI-B003. Conditions listed: Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05924841","url":"https://clinicaltrials.gov/study/NCT05924841"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["adc","bispecific-adc"],"targets":[],"drugs":["izalontamab-brengitecan"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05924841","phase":"2","setting":"A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Extensive Stage Small Cell Lung Cancer (SCLC)","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-11-10","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05990803","kind":"trial","name":"A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies","aka":[],"tldr":"A phase 2 trial of Izalontamab brengitecan in cervical cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies is a phase 2 interventional study registered as NCT05990803 by Sichuan Baili Pharmaceutical Co., Ltd., with 130 participants planned, started 2023-11-06 and due to reach its primary completion in 2026-12. Interventions recorded: BL-B01D1, SI-B003. Conditions listed: Cervical Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05990803","url":"https://clinicaltrials.gov/study/NCT05990803"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["adc","bispecific-adc"],"targets":[],"drugs":["izalontamab-brengitecan"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05990803","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-11-06","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06006169","kind":"trial","name":"A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumor","aka":[],"tldr":"A phase 2 trial of Izalontamab brengitecan in head and neck squamous cell carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors is a phase 2 interventional study registered as NCT06006169 by Sichuan Baili Pharmaceutical Co., Ltd., with 186 participants planned, started 2023-10-20 and due to reach its primary completion in 2026-12. Interventions recorded: BL-B01D1, SI-B003. Conditions listed: Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06006169","url":"https://clinicaltrials.gov/study/NCT06006169"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["adc","bispecific-adc"],"targets":[],"drugs":["izalontamab-brengitecan"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06006169","phase":"2","setting":"A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-10-20","startedType":"actual","enrolled":186,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06437509","kind":"trial","name":"A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Izalontamab brengitecan in small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer is a phase 2 interventional study registered as NCT06437509 by Sichuan Baili Pharmaceutical Co., Ltd., with 66 participants planned, started 2024-06-13 and due to reach its primary completion in 2026-12. Interventions recorded: BL-B01D1, PD-1 monoclonal antibody. Conditions listed: Extensive-stage Small-cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06437509","url":"https://clinicaltrials.gov/study/NCT06437509"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["adc","bispecific-adc"],"targets":[],"drugs":["izalontamab-brengitecan"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06437509","phase":"2","setting":"A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-06-13","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06475300","kind":"trial","name":"A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and ","aka":[],"tldr":"A phase 2 trial of Izalontamab brengitecan, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors is a phase 2 interventional study registered as NCT06475300 by Sichuan Baili Pharmaceutical Co., Ltd., with 570 participants planned, started 2024-06-25 and due to reach its primary completion in 2027-06. Interventions recorded: BL-B01D1, PD-1 Monoclonal Antibody, Pemetrexed Disodium. Conditions listed: Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma, Solid Tumor. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06475300","url":"https://clinicaltrials.gov/study/NCT06475300"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","nasopharyngeal","recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["izalontamab-brengitecan","pemetrexed"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06475300","phase":"2","setting":"A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-06-25","startedType":"actual","enrolled":570,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06437522","kind":"trial","name":"A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors","aka":[],"tldr":"A phase 2 trial of Izalontamab brengitecan in head and neck squamous cell carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors is a phase 2 interventional study registered as NCT06437522 by Sichuan Baili Pharmaceutical Co., Ltd., with 46 participants planned, started 2024-06-07 and due to reach its primary completion in 2027-06. Interventions recorded: BL-B01D1, PD-1 monoclonal antibody. Conditions listed: Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06437522","url":"https://clinicaltrials.gov/study/NCT06437522"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["adc","bispecific-adc"],"targets":[],"drugs":["izalontamab-brengitecan"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06437522","phase":"2","setting":"A Phase II Clinical Trial To Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma) and Other Solid Tumors","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-06-07","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06471205","kind":"trial","name":"A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of BL-B01D1 in triple-negative breast cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer is a phase 2 interventional study registered as NCT06471205 by Sichuan Baili Pharmaceutical Co., Ltd., with 52 participants planned, started 2024-08-02 and due to reach its primary completion in 2026-12. Interventions recorded: BL-B01D1 and PD-1 Monoclonal Antibody.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06471205","url":"https://clinicaltrials.gov/study/NCT06471205"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06471205","phase":"2","setting":"A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody Combination Therapy in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-08-02","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06978114","kind":"trial","name":"A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of Pembrolizumab in biliary tract cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT06978114 by Sichuan Baili Pharmaceutical Co., Ltd., with 46 participants planned, started 2025-06-10 and due to reach its primary completion in 2027-05. Interventions recorded: BL-B01D1 and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06978114","url":"https://clinicaltrials.gov/study/NCT06978114"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06978114","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2025-06-10","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06962787","kind":"trial","name":"A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer","aka":[],"tldr":"A phase 2 trial of Axitinib, Lenvatinib and Pembrolizumab in advanced solid tumours, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer is a phase 2 interventional study registered as NCT06962787 by Sichuan Baili Pharmaceutical Co., Ltd., with 260 participants planned, started 2025-07-28 and due to reach its primary completion in 2027-05. Interventions recorded: BL-B01D1, Axitinib, Lenvatinib and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06962787","url":"https://clinicaltrials.gov/study/NCT06962787"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["axitinib","lenvatinib","pembrolizumab"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06962787","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 in Combination With Tyrosine Kinase Inhibitor (TKI) With or Without Pembrolizumab (BL-B01D1+TKI±Pembrolizumab) in Patients With Locally Advanced or Metastatic Renal Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2025-07-28","startedType":"actual","enrolled":260,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05949619","kind":"trial","name":"A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of BL-M02D1 in non-small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors is a phase 1/2 interventional study registered as NCT05949619 by Sichuan Baili Pharmaceutical Co., Ltd., with 14 participants enrolled, started 2023-09-04 and due to reach its primary completion in 2025-12. Interventions recorded: BL-M02D1.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05949619","url":"https://clinicaltrials.gov/study/NCT05949619"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05949619","phase":"1/2","setting":"A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M02D1 for Injection in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-09-04","startedType":"actual","enrolled":14,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07518173","kind":"trial","name":"A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or M","aka":[],"tldr":"A phase 3 trial of Trastuzumab brengitecan, Pertuzumab, Trastuzumab in her2-positive breast cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer is a phase 3 interventional study registered as NCT07518173 by Sichuan Baili Pharmaceutical Co., Ltd., with 596 participants planned, started 2026-04-21 and due to reach its primary completion in 2029-12. Interventions recorded: BL-M07D1, Pertuzumab, Trastuzumab, Docetaxel. Conditions listed: HER2-positive Breast Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07518173","url":"https://clinicaltrials.gov/study/NCT07518173"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["trastuzumab-brengitecan","pertuzumab","trastuzumab","docetaxel"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07518173","phase":"3","setting":"A Randomized Controlled Phase III Clinical Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-04-21","startedType":"actual","enrolled":596,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07264816","kind":"trial","name":"A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NS","aka":[],"tldr":"A phase 2 trial of Trastuzumab brengitecan, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC is a phase 2 interventional study registered as NCT07264816 by Sichuan Baili Pharmaceutical Co., Ltd., with 80 participants planned, started 2026-02-03 and due to reach its primary completion in 2027-12. Interventions recorded: BL-M07D1, Pembrolizumab. Conditions listed: Non-squamous Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07264816","url":"https://clinicaltrials.gov/study/NCT07264816"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","her2-mutant-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["trastuzumab-brengitecan","pembrolizumab"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07264816","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous Non-Small Cell Lung Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-02-03","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06031584","kind":"trial","name":"A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors","aka":[],"tldr":"A phase 1/2 trial of BL-M07D1 in advanced solid tumours, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors is a phase 1/2 interventional study registered as NCT06031584 by Sichuan Baili Pharmaceutical Co., Ltd., with 42 participants planned, started 2024-01-19 and due to reach its primary completion in 2026-12. Interventions recorded: BL-M07D1.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06031584","url":"https://clinicaltrials.gov/study/NCT06031584"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06031584","phase":"1/2","setting":"A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of BL-M07D1 for Injection in Patients With Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Solid Tumors","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-01-19","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06131450","kind":"trial","name":"A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies","aka":[],"tldr":"A phase 1/2 trial of BL-M07D1 in advanced solid tumours, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies is a phase 1/2 interventional study registered as NCT06131450 by Sichuan Baili Pharmaceutical Co., Ltd., with 138 participants planned, started 2024-02-29 and due to reach its primary completion in 2026-12. Interventions recorded: BL-M07D1.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06131450","url":"https://clinicaltrials.gov/study/NCT06131450"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06131450","phase":"1/2","setting":"A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 for Injection in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-02-29","startedType":"actual","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06114511","kind":"trial","name":"A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of Trastuzumab brengitecan in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer is a phase 1/2 interventional study registered as NCT06114511 by Sichuan Baili Pharmaceutical Co., Ltd., with 78 participants enrolled, started 2024-04-24 and due to reach its primary completion in 2026-12. Interventions recorded: BL-M07D1. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06114511","url":"https://clinicaltrials.gov/study/NCT06114511"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","her2-mutant-nsclc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-brengitecan"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06114511","phase":"1/2","setting":"A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 for Injection in Patients With HER2 Mutated, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-04-24","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06957886","kind":"trial","name":"A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial of Capecitabine, Eribulin and Gemcitabine in HER2-positive breast cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer is a phase 3 interventional study registered as NCT06957886 by Sichuan Baili Pharmaceutical Co., Ltd., with 566 participants planned, started 2025-05-15 and due to reach its primary completion in 2027-05. Interventions recorded: BL-M07D1 and Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06957886","url":"https://clinicaltrials.gov/study/NCT06957886"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["capecitabine","eribulin","gemcitabine"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06957886","phase":"3","setting":"A Randomized, Controlled Phase III Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2025-05-15","startedType":"actual","enrolled":566,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07606599","kind":"trial","name":"A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure","aka":[],"tldr":"A phase 3 trial of Oxaliplatin and Capecitabine in biliary tract cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure is a phase 3 interventional study registered as NCT07606599 by Sichuan Baili Pharmaceutical Co., Ltd., with 398 participants planned, started 2026-07-07 and due to reach its primary completion in 2028-12. Interventions recorded: BL-M07D1, Oxaliplatin, Calcium levofolinate, Fluorouracil, Irinotecan Hydrochloride Liposome and Irinotecan Hydrochloride.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07606599","url":"https://clinicaltrials.gov/study/NCT07606599"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["oxaliplatin","capecitabine"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07606599","phase":"3","setting":"A Phase III Randomized Controlled Clinical Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-07-07","startedType":"actual","enrolled":398,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06830889","kind":"trial","name":"A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy","aka":[],"tldr":"A phase 3 trial of Trastuzumab brengitecan, Trastuzumab emtansine in her2-positive breast cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy is a phase 3 interventional study registered as NCT06830889 by Sichuan Baili Pharmaceutical Co., Ltd., with 1450 participants planned, started 2025-06-03 and due to reach its primary completion in 2031-10. Interventions recorded: BL-M07D1, T-DM1. Conditions listed: HER2-positive Breast Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06830889","url":"https://clinicaltrials.gov/study/NCT06830889"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-brengitecan","trastuzumab-emtansine"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06830889","phase":"3","setting":"A Randomized Controlled Phase Ill Clinical Study of BL-M07D1 for Injection Versus Trastuzumab Emtansine (T-DM1) in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2025-06-03","startedType":"actual","enrolled":1450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07178795","kind":"trial","name":"A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC","aka":[],"tldr":"A phase 3 trial of Trastuzumab brengitecan, Pembrolizumab, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC is a phase 3 interventional study registered as NCT07178795 by Sichuan Baili Pharmaceutical Co., Ltd., with 440 participants planned, started 2025-09-29 and due to reach its primary completion in 2027-12. Interventions recorded: BL-M07D1, Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin. Conditions listed: Non-squamous Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07178795","url":"https://clinicaltrials.gov/study/NCT07178795"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","her2-mutant-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["trastuzumab-brengitecan","pembrolizumab","pemetrexed","carboplatin","cisplatin"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07178795","phase":"3","setting":"A Randomized Controlled Phase III Clinical Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2025-09-29","startedType":"actual","enrolled":440,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06891833","kind":"trial","name":"A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Brea","aka":[],"tldr":"A phase 2/3 trial of Trastuzumab brengitecan, Pertuzumab, Docetaxel in her2-positive breast cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer is a phase 2/3 interventional study registered as NCT06891833 by Sichuan Baili Pharmaceutical Co., Ltd., with 985 participants planned, started 2025-06-05 and due to reach its primary completion in 2028-12. Interventions recorded: BL-M07D1, Pertuzumab, docetaxel, carboplatin, trastuzumab. Conditions listed: HER2-positive Breast Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06891833","url":"https://clinicaltrials.gov/study/NCT06891833"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["trastuzumab-brengitecan","pertuzumab","docetaxel","carboplatin","trastuzumab"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06891833","phase":"2/3","setting":"A Randomized Controlled Phase II/III Clinical Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2025-06-05","startedType":"actual","enrolled":985,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06445400","kind":"trial","name":"A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive ","aka":[],"tldr":"A phase 2 trial of Trastuzumab brengitecan, Pertuzumab, Docetaxel in her2-positive breast cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer is a phase 2 interventional study registered as NCT06445400 by Sichuan Baili Pharmaceutical Co., Ltd., with 83 participants enrolled, started 2024-06-19 and due to reach its primary completion in 2025-07-21. Interventions recorded: BL-M07D1, Pertuzumab, Docetaxel. Conditions listed: HER2-positive Breast Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06445400","url":"https://clinicaltrials.gov/study/NCT06445400"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["trastuzumab-brengitecan","pertuzumab","docetaxel"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06445400","phase":"2","setting":"A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-06-19","startedType":"actual","enrolled":83,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07255872","kind":"trial","name":"A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia","aka":[],"tldr":"A phase 2/3 trial of Cytarabine, Daunorubicin, Venetoclax and Azacitidine in acute myeloid leukaemia, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia is a phase 2/3 interventional study registered as NCT07255872 by Sichuan Baili Pharmaceutical Co., Ltd., with 216 participants planned, started 2026-04-02 and due to reach its primary completion in 2027-12. Interventions recorded: BL-M11D1, Cytarabine, Daunorubicin, Venetoclax and Azacitidine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07255872","url":"https://clinicaltrials.gov/study/NCT07255872"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["bcl2-inhibitors","cytotoxic-chemotherapy","epigenetic-drugs","kinase-inhibitors","topoisomerase-inhibitors"],"targets":[],"drugs":["cytarabine","daunorubicin","venetoclax","azacitidine"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07255872","phase":"2/3","setting":"A Phase II/III Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M11D1 for Injection in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-04-02","startedType":"actual","enrolled":216,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07654400","kind":"trial","name":"A Study of BL-M14D1 in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Atezolizumab in small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of BL-M14D1 in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer is a phase 2 interventional study registered as NCT07654400 by Sichuan Baili Pharmaceutical Co., Ltd., with 36 participants planned, started 2026-07-09 and due to reach its primary completion in 2027-12. Interventions recorded: BL-M14D1, Atezolizumab. Conditions listed: Extensive-stage Small-cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07654400","url":"https://clinicaltrials.gov/study/NCT07654400"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07654400","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M14D1 for Injection in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2026-07-09","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06852222","kind":"trial","name":"A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)","aka":["cAMeLot-2"],"tldr":"A phase 3 trial testing Bleximenib in acute myeloid leukaemia, now recruiting.","summary":"A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukaemia (AML) is a phase 3 interventional study registered as NCT06852222, led by Janssen Research & Development, and recruiting on the registry. Official title: A Phase 3 Randomised, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukaemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy. Planned enrolment is 600 participants (estimated). The study started in 2025-06-04 and primary completion is expected in 2029-06-22. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06852222","url":"https://clinicaltrials.gov/study/NCT06852222"}],"tags":["ctgov-ingest"],"related":[],"cancers":["aml","aml-npm1-kmt2a","aml-older-unfit"],"sections":[],"technologies":[],"targets":[],"drugs":["bleximenib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06852222","phase":"3","setting":"A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy","sponsor":"Janssen Research & Development","started":"2025-06-04","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04895709","kind":"trial","name":"A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Nivolumab, Docetaxel, PM8002 in cervical cancer and colorectal cancer, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT04895709 by Bristol-Myers Squibb, with 1109 participants planned, started 2021-05-27 and due to reach its primary completion in 2031-08-31. Interventions recorded: BMS-986340, BMS-936558-01, Docetaxel, Pumitamig. Conditions listed: Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer, Non-Small-Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04895709","url":"https://clinicaltrials.gov/study/NCT04895709"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","colorectal","nsclc","sclc","melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["nivolumab","docetaxel","pm8002"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04895709","phase":"1/2","setting":"A Phase 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","sponsor":"Bristol-Myers Squibb","started":"2021-05-27","startedType":"actual","enrolled":1109,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05888831","kind":"trial","name":"A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Nivolumab in advanced solid tumours, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05888831 by Bristol-Myers Squibb, with 100 participants enrolled, started 2023-06-06 and due to reach its primary completion in 2026-09-30. Interventions recorded: BMS-986449 and Nivolumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05888831","url":"https://clinicaltrials.gov/study/NCT05888831"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05888831","phase":"1/2","setting":"A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors","sponsor":"Bristol-Myers Squibb","started":"2023-06-06","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06697197","kind":"trial","name":"A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Nivolumab and Bevacizumab in advanced solid tumours, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06697197 by Bristol-Myers Squibb, with 413 participants planned, started 2025-02-17 and due to reach its primary completion in 2029-01-04. Interventions recorded: BMS-986482, Nivolumab and rHuPH20, Nivolumab/relatlimab/rHuPH20 and Bevacizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06697197","url":"https://clinicaltrials.gov/study/NCT06697197"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["nivolumab","bevacizumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06697197","phase":"1/2","setting":"A Phase 1/2 Study of BMS-986482 as Monotherapy or Combination Therapy in Participants With Advanced Solid Tumors","sponsor":"Bristol-Myers Squibb","started":"2025-02-17","startedType":"actual","enrolled":413,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06730750","kind":"trial","name":"A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Bevacizumab in advanced solid tumours, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06730750 by Bristol-Myers Squibb, with 360 participants enrolled, started 2025-02-12 and due to reach its primary completion in 2026-09-05. Interventions recorded: BMS-986490 and Bevacizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06730750","url":"https://clinicaltrials.gov/study/NCT06730750"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["bevacizumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06730750","phase":"1/2","setting":"A Phase 1/2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors","sponsor":"Bristol-Myers Squibb","started":"2025-02-12","startedType":"actual","enrolled":360,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07492680","kind":"trial","name":"A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)","aka":["MountainTAP-5"],"tldr":"A phase 2 trial of Daraxonrasib, Nivolumab, Temozolomide, PM8002, Pemetrexed and Carboplatin in advanced solid tumours, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5) is a phase 2 interventional study registered as NCT07492680 by Bristol-Myers Squibb, with 260 participants planned, started 2026-07-27 and due to reach its primary completion in 2028-08-15. Interventions recorded: BMS-986504, Daraxonrasib, Nivolumab + Relatlimab FDC, Temozolomide, Pumitamig and Pemetrexed.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07492680","url":"https://clinicaltrials.gov/study/NCT07492680"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["daraxonrasib","nivolumab","temozolomide","pm8002","pemetrexed","carboplatin"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07492680","phase":"2","setting":"A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion","sponsor":"Bristol-Myers Squibb","started":"2026-07-27","startedType":"actual","enrolled":260,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07227636","kind":"trial","name":"A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy","aka":[],"tldr":"A phase 2 trial of botensilimab and balstilimab in colorectal cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy is a phase 2, randomised interventional study registered as NCT07227636 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 284 participants, started 2025-11-07 and due to reach its primary completion in 2030-11. Interventions recorded: Botensilimab; Balstilimab; Placebo. Conditions listed: Colorectal Cancer; Rectal Cancer. Primary outcome: Rate of ctDNA clearance (Cohort 1a); Rate of ctDNA clearance (Cohort 1b); Recurrence-free survival (RFS) (Cohort 2a). Colorectal eligibility wording from the registry: \"* Histologically- or cytologically- confirmed colorectal cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07227636","url":"https://clinicaltrials.gov/study/NCT07227636"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","mrd-testing"],"targets":[],"drugs":["botensilimab","balstilimab"],"companies":["agenus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07227636","phase":"2","setting":"Phase II Study of Adjuvant Botensilimab in Combination With Balstilimab in Patients With Colorectal Cancer and Persistent Circulating Tumor DNA Following Surgery and Chemotherapy","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2025-11-07","startedType":"actual","enrolled":284,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06843434","kind":"trial","name":"A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma","aka":[],"tldr":"A phase 2 trial of balstilimab and botensilimab in colorectal cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma is a phase 2, interventional study registered as NCT06843434 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 40 participants, started 2025-02-20 and due to reach its primary completion in 2028-02-20. Interventions recorded: Balstilimab; Botensilimab. Conditions listed: Microsatellite Stable Rectal Carcinoma; Locally Advanced Rectal Adenocarcinoma. Primary outcome: Best Overall Response Rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed rectal adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06843434","url":"https://clinicaltrials.gov/study/NCT06843434"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["balstilimab","botensilimab"],"companies":["agenus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06843434","phase":"2","setting":"A Phase II Study of Neoadjuvant Botensilimab and Balstilimab Immunotherapy for Mismatch Repair Proficient Rectal Adenocarcinoma","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2025-02-20","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05608044","kind":"trial","name":"A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer","aka":["BOT/BAL phase 1b/2 expansion"],"tldr":"A phase 2 trial of Botensilimab in colorectal cancer, run by Agenus Inc., active and no longer recruiting.","summary":"A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer is a phase 2 interventional study registered as NCT05608044 by Agenus Inc., with 234 participants enrolled, started 2022-11-30 and due to reach its primary completion in 2027-09. Interventions recorded: Botensilimab, Balstilimab, Standard of Care. Conditions listed: Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05608044","url":"https://clinicaltrials.gov/study/NCT05608044"},{"label":"Botensilimab plus balstilimab in previously treated microsatellite-stable metastatic colorectal cancer without liver metastases (Clinical Cancer Research 2026)","url":"https://doi.org/10.1158/1078-0432.CCR-26-1610"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["botensilimab"],"companies":["agenus"],"institutions":[],"pathways":[],"terms":["msi","cold-vs-hot"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Agenus's phase 2 of botensilimab, an Fc-enhanced anti-CTLA-4 antibody, with the PD-1 antibody balstilimab is the furthest any regimen has got in microsatellite-stable metastatic colorectal cancer without liver metastases. In the December 2025 data cut, 123 patients (median three previous lines, 67 percent with three or more) had an objective response rate of 21 percent (95% CI 14 to 29), median progression-free survival 4.0 months, median overall survival 21.2 months (95% CI 16.2 to 23.8) and 36-month overall survival 33 percent, with diarrhoea (39 percent, grade 3 or worse 8 percent) and fatigue the commonest treatment-related events. The result is uncontrolled and restricted to patients without active liver metastases, which is itself a favourable prognostic group, so it needs a randomised trial."],"nct":"NCT05608044","phase":"2","setting":"A Randomized, Open-Label, Phase 2 Study of Botensilimab (AGEN1181) as Monotherapy and in Combination With Balstilimab (AGEN2034) or Investigator's Choice Standard of Care (Regorafenib or Trifluridine and Tipiracil) for the Treatment of Refractory Metastatic Colorectal Cancer","sponsor":"Agenus Inc.","started":"2022-11-30","startedType":"actual","yearReported":2026,"enrolled":234,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04752813","kind":"trial","name":"A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)","aka":[],"tldr":"A phase 2 trial of Temozolomide in glioma & glioblastoma, run by BPGbio, active and no longer recruiting.","summary":"A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB) is a phase 2 interventional study registered as NCT04752813 by BPGbio, with 50 participants enrolled, started 2022-08-22 and due to reach its primary completion in 2026-08-25. Interventions recorded: BPM31510, Temozolomide (TMZ) and Radiation.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04752813","url":"https://clinicaltrials.gov/study/NCT04752813"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04752813","phase":"2","setting":"A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)","sponsor":"BPGbio","started":"2022-08-22","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02972840","kind":"trial","name":"A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL","aka":["ECHO","Acalabrutinib with bendamustine and rituximab in untreated mantle cell lymphoma"],"tldr":"A phase 3 trial of Acalabrutinib, Bendamustine and Rituximab in mantle cell lymphoma, run by Acerta Pharma BV, active and no longer recruiting.","summary":"A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL is a phase 3 interventional study registered as NCT02972840 by Acerta Pharma BV, with 635 participants enrolled, started 2017-04-05 and due to reach its primary completion in 2027-02-15. Interventions recorded: Acalabrutinib, Bendamustine, Rituximab and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02972840","url":"https://clinicaltrials.gov/study/NCT02972840"}],"tags":["pipeline","ctgov-ingest"],"related":["lymphoma-roadmap","paper-echo-acalabrutinib-bendamustine-rituximab-mantle-cell-jco-2025","shine","enrich"],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","monoclonal-antibody"],"targets":["btk","cd20","ccnd1"],"drugs":["acalabrutinib","bendamustine","rituximab"],"companies":["astrazeneca"],"institutions":[],"pathways":["bcr-signalling"],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-echo-acalabrutinib-bendamustine-rituximab-mantle-cell-jco-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02972840","phase":"3","setting":"A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma","sponsor":"Acerta Pharma BV","result":"Median progression-free survival 66.4 against 49.6 months (hazard ratio 0.73, p = 0.0160), with no significant overall survival difference (hazard ratio 0.86, p = 0.27).","started":"2017-04-05","startedType":"actual","yearReported":2025,"enrolled":635,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02979522","kind":"trial","name":"A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma","aka":[],"tldr":"A phase 1/2 trial of Brentuximab vedotin, Doxorubicin, Vinblastine and Dacarbazine in hodgkin lymphoma, run by Takeda, active and no longer recruiting.","summary":"A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma is a phase 1/2 interventional study registered as NCT02979522 by Takeda, with 59 participants enrolled, started 2017-09-06 and due to reach its primary completion in 2020-05-05. Interventions recorded: Brentuximab vedotin, Doxorubicin, Vinblastine and Dacarbazine. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02979522","url":"https://clinicaltrials.gov/study/NCT02979522"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","advanced-stage-classical-hodgkin-lymphoma"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy"],"targets":[],"drugs":["brentuximab-vedotin","doxorubicin","vinblastine","dacarbazine"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02979522","phase":"1/2","setting":"An Open-Label Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma","sponsor":"Takeda","started":"2017-09-06","startedType":"actual","yearReported":2021,"enrolled":59,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase 2: Percentage of Participants Who Achieved a Complete Remission (CR) Per Independent Review Facility (IRF) Assessment Per International Working Group (IWG) Criteria at End of Treatment (EOT) Visit","primary":true,"unit":"%","arms":[{"name":"Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD","n":51,"value":75,"note":"95% CI 60 to 86; Figures from the ClinicalTrials.gov results section (first posted 2021-06-01), not from a publication"},{"name":"Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD","n":59,"value":76,"note":"95% CI 63 to 86"}],"source":"https://clinicaltrials.gov/study/NCT02979522?tab=results"},{"endpoint":"Phase 2: Percentage of Participants Who Achieved an Overall Response Rate (ORR) Per IRF Assessment Per IWG Criteria at EOT Visit","primary":true,"unit":"%","arms":[{"name":"Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD","n":51,"value":86,"note":"95% CI 74 to 94; Figures from the ClinicalTrials.gov results section (first posted 2021-06-01), not from a publication"},{"name":"Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD","n":59,"value":88,"note":"95% CI 77 to 95"}],"source":"https://clinicaltrials.gov/study/NCT02979522?tab=results"}]},{"id":"nct05673785","kind":"trial","name":"A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)","aka":[],"tldr":"A phase 2 trial of Brentuximab vedotin, Cyclophosphamide, Doxorubicin and Prednisone in non-Hodgkin lymphoma, run by Takeda, active and no longer recruiting.","summary":"A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL) is a phase 2 interventional study registered as NCT05673785 by Takeda, with 52 participants enrolled, started 2023-02-10 and due to reach its primary completion in 2025-04-27. Interventions recorded: Brentuximab Vedotin, Cyclophosphamide, Doxorubicin and Prednisone. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05673785","url":"https://clinicaltrials.gov/study/NCT05673785"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","peripheral-t-cell-lymphoma"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy"],"targets":[],"drugs":["brentuximab-vedotin","cyclophosphamide","doxorubicin","prednisone"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05673785","phase":"2","setting":"A Phase 2, Single-Arm, Open-Label, Multicenter Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in the Frontline Treatment of Chinese Patients With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)","sponsor":"Takeda","started":"2023-02-10","startedType":"actual","yearReported":2026,"enrolled":52,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Response Rate (ORR) by Independent Review Facility (IRF) Assessment Per Revised Response Criteria for Malignant Lymphoma","primary":true,"unit":"%","arms":[{"name":"Brentuximab Vedotin + CHP","n":52,"value":96.2,"note":"95% CI 86.8 to 99.5; Figures from the ClinicalTrials.gov results section (first posted 2026-06-12), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT05673785?tab=results"}]},{"id":"nct05521802","kind":"trial","name":"A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 1/2 trial of B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell in multiple myeloma, run by Shanghai AbelZeta Ltd., now recruiting.","summary":"A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT05521802 by Shanghai AbelZeta Ltd., with 92 participants planned, started 2022-11-11 and due to reach its primary completion in 2024-07. Interventions recorded: B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05521802","url":"https://clinicaltrials.gov/study/NCT05521802"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shanghai-abelzeta"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05521802","phase":"1/2","setting":"A Phase Ib/II Study of CBM.BCMA Chimeric Antigen Receptor T Cell Product (C-CAR088) for Treating Patients With Relapsed or Refractory Multiple Myeloma","sponsor":"Shanghai AbelZeta Ltd.","started":"2022-11-11","startedType":"actual","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03690388","kind":"trial","name":"A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Va","aka":[],"tldr":"A phase 3 trial of Cabozantinib in thyroid cancer, run by Exelixis, active and no longer recruiting.","summary":"A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy is a phase 3 interventional study registered as NCT03690388 by Exelixis, with 187 participants enrolled, started 2018-10-05 and due to reach its primary completion in 2020-08-19. Interventions recorded: Cabozantinib, Placebo. Conditions listed: Differentiated Thyroid Cancer. Results were posted on ClinicalTrials.gov in 2023; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03690388","url":"https://clinicaltrials.gov/study/NCT03690388"}],"tags":["ctgov-ingest"],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["cabozantinib"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03690388","phase":"3","setting":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects With Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy","sponsor":"Exelixis","started":"2018-10-05","startedType":"actual","yearReported":2023,"enrolled":187,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Cabozantinib","n":125,"note":"The CI 5.7 to 0.0 is not 0.0 but NA. The median PFS and upper bound of the CI could not be determined because not enough subjects on the cabozantinib arm had e…; Figures from the ClinicalTrials.gov results section (first posted 2023-05-18), not from a publication"},{"name":"Placebo","n":62,"value":1.9,"note":"96% CI 1.8 to 3.6"}],"hr":0.22,"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT03690388?tab=results"},{"endpoint":"Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Cabozantinib","n":67,"value":15,"note":"99% CI 5.8 to 29.3; Figures from the ClinicalTrials.gov results section (first posted 2023-05-18), not from a publication"},{"name":"Placebo","n":33,"value":0,"note":"99% CI 0.0 to 14.8"}],"source":"https://clinicaltrials.gov/study/NCT03690388?tab=results"}]},{"id":"nct06345729","kind":"trial","name":"A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)","aka":["KANDLELIT-004"],"tldr":"A phase 3 trial testing Calderasib in non-small-cell lung cancer, now recruiting.","summary":"A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumour Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004) is a phase 3 interventional study registered as NCT06345729, led by Merck Sharp & Dohme, and recruiting on the registry. Official title: A Phase 3, Randomised, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004). Planned enrolment is 600 participants (estimated). The study started in 2024-05-24 and primary completion is expected in 2029-02-19. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06345729","url":"https://clinicaltrials.gov/study/NCT06345729"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["calderasib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06345729","phase":"3","setting":"A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)","sponsor":"Merck Sharp & Dohme","started":"2024-05-24","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05774951","kind":"trial","name":"A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy","aka":["CAMBRIA-1"],"tldr":"A phase 3 trial of Camizestrant, Tamoxifen and Exemestane in advanced solid tumours, run by AstraZeneca, now recruiting.","summary":"A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy is a phase 3 interventional study registered as NCT05774951 by AstraZeneca, with 4300 participants planned, started 2023-03-31 and due to reach its primary completion in 2027-04-20. Interventions recorded: Camizestrant, Tamoxifen, Anastrozole, Letrozole and Exemestane.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05774951","url":"https://clinicaltrials.gov/study/NCT05774951"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["camizestrant","tamoxifen","exemestane"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05774951","phase":"3","setting":"CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence","sponsor":"AstraZeneca","started":"2023-03-31","startedType":"actual","enrolled":4300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05999149","kind":"trial","name":"A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BC","aka":["BCTOP-T-N01"],"tldr":"A phase 3 trial of camrelizumab in triple-negative breast cancer, run by Fudan University, now recruiting.","summary":"A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01) is a phase 3, randomised interventional study registered as NCT05999149 by Fudan University, with a registry enrolment figure of 424 participants, started 2023-08-20 and due to reach its primary completion in 2025-08-30. Interventions recorded: Camrelizumab Plus Chemotherapy and Famitinib; Camrelizumab Plus Chemotherapy. Conditions listed: TNBC - Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05999149","url":"https://clinicaltrials.gov/study/NCT05999149"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["camrelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05999149","phase":"3","setting":"A Randomized, Open Label, Multicenter Phase III Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)","sponsor":"Fudan University","started":"2023-08-20","startedType":"actual","enrolled":424,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06915246","kind":"trial","name":"A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma","aka":[],"tldr":"A phase 2 trial of Carmustine in hodgkin lymphoma and non-hodgkin lymphoma, run by VIVUS LLC, now recruiting.","summary":"A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma is a phase 2 interventional study registered as NCT06915246 by VIVUS LLC, with 49 participants planned, started 2025-03-12 and due to reach its primary completion in 2027-03-31. Interventions recorded: VI-0609, BiCNU. Conditions listed: Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06915246","url":"https://clinicaltrials.gov/study/NCT06915246"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["carmustine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06915246","phase":"2","setting":"A Randomized Phase 2 Study of Carmustine Formulated With and Without Ethanol as Part of BEAM Chemotherapy Conditioning for Subjects With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation (AHCT)","sponsor":"VIVUS LLC","started":"2025-03-12","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05849480","kind":"trial","name":"A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)","aka":[],"tldr":"A phase 1/2 trial of oxaliplatin, capecitabine and CAPOX in gallbladder cancer and other biliary tract cancers, run by National Cancer Institute (NCI), now recruiting.","summary":"A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC) is a phase 1/2 interventional study registered as NCT05849480 by National Cancer Institute (NCI), with a registry enrolment figure of 60 participants, started 2024-05-08 and due to reach its primary completion in 2040-06-01. Interventions recorded: oxaliplatin, capecitabine, Keytruda, CDX-1140. Conditions listed: Biliary Cancer, Bile Duct Cancer, Cancer of the Bile Duct. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05849480","url":"https://clinicaltrials.gov/study/NCT05849480"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["oxaliplatin","capecitabine","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05849480","phase":"1/2","setting":"A Phase I/II Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)","sponsor":"National Cancer Institute (NCI)","started":"2024-05-08","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06465329","kind":"trial","name":"A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Ce","aka":[],"tldr":"A phase 2 trial of Cemiplimab in non-small-cell lung cancer and small-cell lung cancer, run by Regeneron Pharmaceuticals, active and no longer recruiting.","summary":"A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC) is a phase 2 interventional study registered as NCT06465329 by Regeneron Pharmaceuticals, with 120 participants planned, started 2024-11-18 and due to reach its primary completion in 2027-05-20. Interventions recorded: Cemiplimab, Platinum-based chemotherapy, REGN7075. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06465329","url":"https://clinicaltrials.gov/study/NCT06465329"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06465329","phase":"2","setting":"A Randomized Phase 2 Platform Study to Evaluate Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for the Perioperative Treatment of Patients With Resectable Non-Small Cell Lung Cancer","sponsor":"Regeneron Pharmaceuticals","started":"2024-11-18","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05061134","kind":"trial","name":"A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition","aka":["MONETTE"],"tldr":"A phase 2 trial of Ceralasertib, Durvalumab in melanoma, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition is a phase 2 interventional study registered as NCT05061134 by AstraZeneca, with 194 participants enrolled, started 2022-08-11 and due to reach its primary completion in 2024-04-12. Interventions recorded: Ceralasertib, Durvalumab. Conditions listed: Melanoma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05061134","url":"https://clinicaltrials.gov/study/NCT05061134"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ceralasertib","durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05061134","phase":"2","setting":"A Randomised, Open-Label, Phase 2 Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Unresectable or Advanced Melanoma and Primary or Secondary Resistance to PD-(L)1 Inhibition","sponsor":"AstraZeneca","started":"2022-08-11","startedType":"actual","yearReported":2025,"enrolled":194,"enrolledBasis":"registry","outcomes":[{"endpoint":"Main Study: Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Main Study: Ceralasertib + Durvalumab","n":97,"value":9.3,"note":"95% CI 4.3 to 16.9; Figures from the ClinicalTrials.gov results section (first posted 2025-05-21), not from a publication"},{"name":"Main Study: Ceralasertib Monotherapy","n":52,"value":5.8,"note":"95% CI 1.2 to 15.9"}],"source":"https://clinicaltrials.gov/study/NCT05061134?tab=results"},{"endpoint":"Main Study and Biopsy Study: Overall Survival (OS)","unit":"months","arms":[{"name":"Main Study: Ceralasertib + Durvalumab","n":100,"value":16,"note":"95% CI 10.48 to NA; Figures from the ClinicalTrials.gov results section (first posted 2025-05-21), not from a publication"},{"name":"Main Study: Ceralasertib Monotherapy","n":51,"value":12.32,"note":"95% CI 9.46 to NA"},{"name":"Biopsy Study: Ceralasertib + Durvalumab","n":41,"note":"Here, NA indicate that median and upper limit of 95% CI was not evaluable due to insufficient number of participants with events and due to the duration of fol…"}],"source":"https://clinicaltrials.gov/study/NCT05061134?tab=results"},{"endpoint":"Main Study and Biopsy Study: Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Main Study: Ceralasertib + Durvalumab","n":100,"value":2,"note":"95% CI 1.91 to 3.52; Figures from the ClinicalTrials.gov results section (first posted 2025-05-21), not from a publication"},{"name":"Main Study: Ceralasertib Monotherapy","n":51,"value":1.94,"note":"95% CI 1.91 to 3.06"},{"name":"Biopsy Study: Ceralasertib + Durvalumab","n":41,"value":2.83,"note":"95% CI 2.76 to 4.47"}],"source":"https://clinicaltrials.gov/study/NCT05061134?tab=results"}]},{"id":"nct07000305","kind":"trial","name":"A Study of Cetuximabβ Combined With Envolimab and mFOLFOX6 in Subjects With Advanced Colorectal Cancer","aka":["SUPβORT"],"tldr":"A phase 2 trial in colorectal cancer, run by Tao Zhang, not yet recruiting.","summary":"A Study of Cetuximabβ Combined With Envolimab and mFOLFOX6 in Subjects With Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT07000305 by Tao Zhang, with a registry enrolment figure of 42 participants, started 2025-05-20 and due to reach its primary completion in 2027-05-20. Interventions recorded: Cetuximabβ combined with Envolimab and mFOLFOX6. Conditions listed: Advanced Colorectal Cancer. Primary outcome: Progression-free survival (PFS). Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed RAS and BRAF wild-type, MSS type colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07000305","url":"https://clinicaltrials.gov/study/NCT07000305"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07000305","phase":"2","setting":"Cetuximabβ Combined With Envolimab and mFOLFOX6 as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable , Metastatic Colorectal Cancer: A Single-arm, Multi-center, Phase II Trail","sponsor":"Tao Zhang","started":"2025-05-20","startedType":"estimated","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04730258","kind":"trial","name":"A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML","aka":[],"tldr":"A phase 1/2 trial of Azacitidine in chronic myelomonocytic leukaemia and mds/mpn overlap neoplasms, run by Treadwell Therapeutics, Inc, active and no longer recruiting.","summary":"A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML is a phase 1/2 interventional study registered as NCT04730258 by Treadwell Therapeutics, Inc, with 72 participants planned, started 2021-04-16 and due to reach its primary completion in 2026-01. Interventions recorded: CFI-400945, Azacitidine. Conditions listed: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, AML. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04730258","url":"https://clinicaltrials.gov/study/NCT04730258"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cmml"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["azacitidine"],"companies":["treadwell-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04730258","phase":"1/2","setting":"Phase 1b/2 Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of CFI-400945 as a Single Agent or in Combination With Azacitidine in Patients With AML, MDS or CMML","sponsor":"Treadwell Therapeutics, Inc","started":"2021-04-16","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07412262","kind":"trial","name":"A Study of Chidamide Combined With Ivonescimab in the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) With Acquired Resistance to Immunotherapy and Hig","aka":["NSCLC， YAP"],"tldr":"A phase 2 trial of ivonescimab in lung cancer, run by Guangdong Association of Clinical Trials, now recruiting.","summary":"A Study of Chidamide Combined With Ivonescimab in the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) With Acquired Resistance to Immunotherapy and High Yes-associated Protein (YAP) Expression is a phase 2, interventional study registered as NCT07412262 by Guangdong Association of Clinical Trials, with a registry enrolment figure of 32 participants, started 2026-08-28 and due to reach its primary completion in 2028-03-31. Interventions recorded: Chidamide in combination with Ivonescimab. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Progression Free Survival(PFS) per Response Evaluation Criteria in Solid tumors (RECIST) v1.1. Lung eligibility wording from the registry: \"Have histologically or cytologically confirmed locally advanced (IIIB/IIIC stage), metastatic or recurrent (IV stage) non-small cell lung cancer (NSCLC) that is not operable and not suitable for radical concurrent chemoradiotherapy, as classified by the 9th edition of the TNM staging system of the I\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07412262","url":"https://clinicaltrials.gov/study/NCT07412262"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07412262","phase":"2","setting":"A Prospective, Single-Arm, Multicenter, Phase II Clinical Study of Chidamide Combined With Ivonescimab in the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) With Acquired Resistance to Immunotherapy and High Yes-associated Protein (YAP) Expression","sponsor":"Guangdong Association of Clinical Trials","started":"2026-08-28","startedType":"estimated","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06550895","kind":"trial","name":"A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma","aka":["MonumenTAL-8"],"tldr":"A phase 2 trial of Ciltacabtagene autoleucel, Talquetamab in multiple myeloma, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma is a phase 2 interventional study registered as NCT06550895 by Janssen Research & Development, LLC, with 11 participants enrolled, started 2024-09-16 and due to reach its primary completion in 2027-08-26. Interventions recorded: Cilta-cel, Talquetamab. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06550895","url":"https://clinicaltrials.gov/study/NCT06550895"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["car-t","t-cell-engager"],"targets":[],"drugs":["ciltacabtagene-autoleucel","talquetamab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06550895","phase":"2","setting":"A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma","sponsor":"Janssen Research & Development, LLC","started":"2024-09-16","startedType":"actual","enrolled":11,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05299424","kind":"trial","name":"A Study of CM336 in Patients With Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 1/2 trial of CM336_group 1 in multiple myeloma, run by Keymed Biosciences Co.Ltd, now recruiting.","summary":"A Study of CM336 in Patients With Relapsed or Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT05299424 by Keymed Biosciences Co.Ltd, with 48 participants planned, started 2022-08-09 and due to reach its primary completion in 2026-12. Interventions recorded: CM336_group 1, CM336_group 2a, CM336_group 2b, CM336_group 3a, CM336_group 3b and CM336_group 4a.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05299424","url":"https://clinicaltrials.gov/study/NCT05299424"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["keymed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05299424","phase":"1/2","setting":"A Multi-center, Open-label, Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Multiple Myeloma","sponsor":"Keymed Biosciences Co.Ltd","started":"2022-08-09","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05263960","kind":"trial","name":"A Study of CM350 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of CM350 group1 in advanced solid tumours, run by Keymed Biosciences Co.Ltd, now recruiting.","summary":"A Study of CM350 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05263960 by Keymed Biosciences Co.Ltd, with 248 participants planned, started 2022-04-21 and due to reach its primary completion in 2027-04. Interventions recorded: CM350 group1, CM350 group2 and CM350 group3.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05263960","url":"https://clinicaltrials.gov/study/NCT05263960"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["keymed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05263960","phase":"1/2","setting":"A Multicenter, Open Label, Phase I/II Clinical Study of CM350 in Patients With Advanced Solid Tumors","sponsor":"Keymed Biosciences Co.Ltd","started":"2022-04-21","startedType":"actual","enrolled":248,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05759728","kind":"trial","name":"A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of CNA3103: 5 x 10^7 cells in colorectal cancer, run by Carina Biotech Limited, now recruiting.","summary":"A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer is a phase 1/2 interventional study registered as NCT05759728 by Carina Biotech Limited, with 45 participants planned, started 2023-10-24 and due to reach its primary completion in 2027-12. Interventions recorded: CNA3103: 5 x 10^7 cells, CNA3103: 1.5 x 10^8 cells, CNA3103: 4.5 x 10^8 cells, CNA3103: 1.5 x 10^9 cells, CNA3103: 2.5 x 10^7 cells and CNA3103: 6.75 × 10^8 cells.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05759728","url":"https://clinicaltrials.gov/study/NCT05759728"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05759728","phase":"1/2","setting":"A Phase 1/2a, Multicenter, Open-Label, Dose Escalation and Expansion Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Adult Subjects With Metastatic Colorectal Cancer","sponsor":"Carina Biotech Limited","started":"2023-10-24","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05667506","kind":"trial","name":"A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)","aka":[],"tldr":"A phase 1/2 trial of single dose of CNCT19 in acute lymphoblastic leukaemia, run by Juventas Cell Therapy Ltd., now recruiting.","summary":"A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric) is a phase 1/2 interventional study registered as NCT05667506 by Juventas Cell Therapy Ltd., with 47 participants planned, started 2023-02-07 and due to reach its primary completion in 2025-05-30. Interventions recorded: single dose of CNCT19.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05667506","url":"https://clinicaltrials.gov/study/NCT05667506"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","all-paediatric-relapsed"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["inaticabtagene-autoleucel"],"companies":["juventas-cell-therapy"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05667506","phase":"1/2","setting":"A Phase Ib/II, Single Arm, Multi-center Study Evaluating the Safety and Efficacy of CNCT19 in Children and Adolescent(Pediatric) Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)","sponsor":"Juventas Cell Therapy Ltd.","started":"2023-02-07","startedType":"actual","enrolled":47,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06521567","kind":"trial","name":"A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer","aka":["POPSTAR"],"tldr":"A phase 1/2 trial of Cobolimab, Dostarlimab in melanoma and hodgkin lymphoma, run by GlaxoSmithKline, active and no longer recruiting.","summary":"A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer is a phase 1/2 interventional study registered as NCT06521567 by GlaxoSmithKline, with 83 participants planned, started 2025-03-06 and due to reach its primary completion in 2026-10-13. Interventions recorded: Cobolimab, Dostarlimab. Conditions listed: Melanoma, Hodgkin Lymphoma, High and Low Grade Glioma, Glioblastoma Multiforme (GBM). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06521567","url":"https://clinicaltrials.gov/study/NCT06521567"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","hodgkin-lymphoma","dipg-dmg","ependymoma","osteosarcoma"],"sections":[],"technologies":["checkpoint-inhibitor","tim3-blockade"],"targets":[],"drugs":["cobolimab","dostarlimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06521567","phase":"1/2","setting":"Phase 1/2 Dose Determination and Dose Expansion Study of Cobolimab in Combination With Dostarlimab in Pediatric and Young Adult Participants With Newly Diagnosed and Relapsed/Refractory Tumors (POPSTAR)","sponsor":"GlaxoSmithKline","started":"2025-03-06","startedType":"actual","enrolled":83,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04538664","kind":"trial","name":"A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions","aka":["PAPILLON"],"tldr":"A phase 3 trial of Amivantamab, Pemetrexed and Carboplatin in non-small-cell lung cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions is a phase 3 interventional study registered as NCT04538664 by Janssen Research & Development, LLC, with 308 participants enrolled, started 2020-10-13 and due to reach its primary completion in 2023-05-03. Interventions recorded: Amivantamab, Pemetrexed and Carboplatin. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04538664","url":"https://clinicaltrials.gov/study/NCT04538664"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["bispecific-antibody","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["amivantamab","pemetrexed","carboplatin"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04538664-n-engl-j-med-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04538664","phase":"3","setting":"A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Janssen Research & Development, LLC","started":"2020-10-13","startedType":"actual","yearReported":2024,"enrolled":308,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)","primary":true,"unit":"months","arms":[{"name":"Arm B: Chemotherapy Alone","n":155,"value":6.7,"note":"95% CI 5.59 to 7.33; Figures from the ClinicalTrials.gov results section (first posted 2024-05-29), not from a publication"},{"name":"Arm A: Amivantamab + Chemotherapy","n":153,"value":11.37,"note":"95% CI 9.79 to 13.70"}],"hr":0.395,"ci":[0.296,0.528],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT04538664?tab=results"}]},{"id":"nct05908734","kind":"trial","name":"A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer","aka":["PolyDamas"],"tldr":"A phase 1/2 trial of Cetrelimab and Amivantamab in non-small-cell lung cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT05908734 by Janssen Research & Development, LLC, with 71 participants enrolled, started 2023-05-18 and due to reach its primary completion in 2027-01-31. Interventions recorded: Cetrelimab and Amivantamab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05908734","url":"https://clinicaltrials.gov/study/NCT05908734"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["bispecific-antibody"],"targets":[],"drugs":["cetrelimab","amivantamab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05908734","phase":"1/2","setting":"A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer","sponsor":"Janssen Research & Development, LLC","started":"2023-05-18","startedType":"actual","enrolled":71,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03314181","kind":"trial","name":"A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractor","aka":[],"tldr":"A phase 2 trial of Dexamethasone, Daratumumab, Venetoclax in multiple myeloma, run by AbbVie, active and no longer recruiting.","summary":"A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT03314181 by AbbVie, with 156 participants enrolled, started 2018-04-02 and due to reach its primary completion in 2031-05. Interventions recorded: Dexamethasone, Daratumumab, Venetoclax, Bortezomib. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03314181","url":"https://clinicaltrials.gov/study/NCT03314181"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","bcl2-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["dexamethasone","daratumumab","venetoclax","bortezomib"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03314181","phase":"2","setting":"A Phase 1/2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects With Relapsed or Refractory Multiple Myeloma","sponsor":"AbbVie","started":"2018-04-02","startedType":"actual","enrolled":156,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05859217","kind":"trial","name":"A Study of Combining Cabozantinib and Atezolizumab for Advanced/Metastatic NSCLC (Cabatezo-1)","aka":["Cabatezo-1"],"tldr":"A phase 2 trial of cabozantinib and atezolizumab in lung cancer, run by Jun Zhang, MD, PhD, not yet recruiting.","summary":"A Study of Combining Cabozantinib and Atezolizumab for Advanced/Metastatic NSCLC (Cabatezo-1) is a phase 2, interventional study registered as NCT05859217 by Jun Zhang, MD, PhD, with a registry enrolment figure of 40 participants, started 2024-12 and due to reach its primary completion in 2026-06. Interventions recorded: Cabozantinib; Atezolizumab. Conditions listed: Lung Cancer; NSCLC Stage IV; Metastatic NSCLC - Non-Small Cell Lung Cancer; Advanced NSCLC. Primary outcome: Objective response rate (ORR). Lung eligibility wording from the registry: \"* Pathologically confirmed advanced/metastatic NSCLC, with PD-L1\\<1% based on IHC using 22C3 antibody\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05859217","url":"https://clinicaltrials.gov/study/NCT05859217"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cabozantinib","atezolizumab"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05859217","phase":"2","setting":"A Multi-center Phase II Study of Combining Cabozantinib and Atezolizumab as the 1st Line Therapy for PD-L1 Negative Advanced/Metastatic NSCLC (Cabatezo-1)","sponsor":"Jun Zhang, MD, PhD","started":"2024-12","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06246643","kind":"trial","name":"A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies","aka":[],"tldr":"A phase 2 trial of Regorafenib in advanced solid tumours, run by Bayer, active and no longer recruiting.","summary":"A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies is a phase 2 interventional study registered as NCT06246643 by Bayer, with 13 participants enrolled, started 2024-01-24 and due to reach its primary completion in 2028-04-27. Interventions recorded: Regorafenib (Stivarga, BAY73-4506).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06246643","url":"https://clinicaltrials.gov/study/NCT06246643"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["regorafenib"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06246643","phase":"2","setting":"A Single Arm, Open-label, Multicenter Phase 2 Study of Regorafenib in Participants Who Have Been Treated in a Previous Bayer-sponsored Regorafenib Study (Monotherapy or Combination Treatment) That Has Reached the Primary Completion Endpoint or the Main Data Analysis or Has Been Stopped Prematurely.","sponsor":"Bayer","started":"2024-01-24","startedType":"actual","enrolled":13,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07070219","kind":"trial","name":"A Study of CTD402 in T-ALL/LBL Patients","aka":["TENACITY-01"],"tldr":"A phase 1/2 trial of CTD402 CAR T Cell Injection in acute lymphoblastic leukaemia and non-Hodgkin lymphoma, run by Imviva Bio, now recruiting.","summary":"A Study of CTD402 in T-ALL/LBL Patients is a phase 1/2 interventional study registered as NCT07070219 by Imviva Bio, with 118 participants planned, started 2025-10-07 and due to reach its primary completion in 2028-09-30. Interventions recorded: CTD402 CAR T Cell Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07070219","url":"https://clinicaltrials.gov/study/NCT07070219"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07070219","phase":"1/2","setting":"A Single-Arm, Open-Label, Multi-Center, Phase 1b/ 2 Study to Evaluate the Safety, Efficacy, and Cellular Pharmacokinetic Profile of CTD402 in Participants With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and Lymphoblastic Lymphoma (T-LBL) (TENACITY-01)","sponsor":"Imviva Bio","started":"2025-10-07","startedType":"actual","enrolled":118,"enrolledBasis":"registry","outcomes":[]},{"id":"companion-002","kind":"trial","name":"A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)","aka":["COMPANION-002"],"tldr":"A phase 2/3 trial testing Tovecimig in biliary tract cancer and bladder & urothelial cancer, active and no longer recruiting.","summary":"A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002) is a phase 2/3 interventional study registered as NCT05506943, led by Compass Therapeutics, and active but no longer recruiting on the registry. Official title: A Phase 2/3 Randomised, Controlled Study of CTX-009 in Combination With Paclitaxel Versus Paclitaxel Alone in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen. Planned enrolment is 168 participants (actual). The study started in 2023-01-09 and primary completion is expected in 2027-08-31. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05506943","url":"https://clinicaltrials.gov/study/NCT05506943"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma","urothelial"],"sections":[],"technologies":[],"targets":[],"drugs":["tovecimig"],"companies":["compass-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05506943","phase":"2/3","setting":"A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination With Paclitaxel Versus Paclitaxel Alone in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen","sponsor":"Compass Therapeutics","started":"2023-01-09","startedType":"actual","enrolled":168,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05732103","kind":"trial","name":"A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes","aka":[],"tldr":"A phase 1/2 trial of CTX-712 in acute myeloid leukaemia and myelodysplastic syndromes / neoplasms, run by Chordia Therapeutics, Inc., now recruiting.","summary":"A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes is a phase 1/2 interventional study registered as NCT05732103 by Chordia Therapeutics, Inc., with 225 participants planned, started 2023-04-25 and due to reach its primary completion in 2028-06. Interventions recorded: CTX-712.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05732103","url":"https://clinicaltrials.gov/study/NCT05732103"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","mds","mds-higher-risk"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05732103","phase":"1/2","setting":"Phase 1/2 Multicenter, Open-Label Study of CTX-712 in Patients With Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes","sponsor":"Chordia Therapeutics, Inc.","started":"2023-04-25","startedType":"actual","enrolled":225,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04023526","kind":"trial","name":"A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy","aka":["CULMINATE"],"tldr":"A phase 2 trial of Azacitidine and Cusatuzumab in acute myeloid leukaemia, run by OncoVerity, Inc., active and no longer recruiting.","summary":"A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy is a phase 2 interventional study registered as NCT04023526 by OncoVerity, Inc., with 103 participants enrolled, started 2019-07-29 and due to reach its primary completion in 2023-08-15. Interventions recorded: Azacitidine and Cusatuzumab. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04023526","url":"https://clinicaltrials.gov/study/NCT04023526"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["azacitidine","cusatuzumab"],"companies":["oncoverity","argenx","johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04023526","phase":"2","setting":"A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy","sponsor":"OncoVerity, Inc.","started":"2019-07-29","startedType":"actual","yearReported":2024,"enrolled":103,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Complete Remission (CR)","primary":true,"unit":"%","arms":[{"name":"Cusatuzumab 10 mg/kg Plus Azacitidine","n":51,"value":11.76,"note":"95% CI 5.5 to 23.4; Figures from the ClinicalTrials.gov results section (first posted 2024-07-30), not from a publication"},{"name":"Cusatuzumab 20 mg/kg Plus Azacitidine","n":52,"value":26.92,"note":"95% CI 16.8 to 40.3"}],"source":"https://clinicaltrials.gov/study/NCT04023526?tab=results"},{"endpoint":"Overall Response Rate (ORR)","unit":"%","arms":[{"name":"Cusatuzumab 10 mg/kg Plus Azacitidine","n":51,"value":29.4,"note":"95% CI 18.7 to 43; Figures from the ClinicalTrials.gov results section (first posted 2024-07-30), not from a publication"},{"name":"Cusatuzumab 20 mg/kg Plus Azacitidine","n":52,"value":40.4,"note":"95% CI 28.2 to 53.9"}],"source":"https://clinicaltrials.gov/study/NCT04023526?tab=results"}]},{"id":"nct07768436","kind":"trial","name":"A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for People With Breast Cancer","aka":[],"tldr":"A phase 2 trial of paclitaxel / nab-paclitaxel in triple-negative breast cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for People With Breast Cancer is a phase 2, interventional study registered as NCT07768436 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 76 participants, started 2026-08-11 and due to reach its primary completion in 2030-08-11. Interventions recorded: CMF Regimen; Paclitaxel. Conditions listed: Adenocarcinoma of the Breast; Breast Cancer; Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Cohort 2 only: Patients have triple negative (ER- (10%) PR-Her 2 Neu -) in the neoadjuvant setting\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07768436","url":"https://clinicaltrials.gov/study/NCT07768436"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07768436","phase":"2","setting":"STUDY OF DOSE DENSE CMF (Cyclophosphamide, Methotrexate, Fluorouracil) as an Alternative to AC (Doxorubicin, Cyclophosphamide) in 2 Regimens in EARLY STAGE BREAST CANCER for Patients Greater or Equal to 70","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2026-08-11","startedType":"actual","enrolled":76,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05410145","kind":"trial","name":"A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed and Cetuximab in advanced solid tumours, run by D3 Bio (Wuxi) Co., Ltd, now recruiting.","summary":"A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation is a phase 1/2 interventional study registered as NCT05410145 by D3 Bio (Wuxi) Co., Ltd, with 442 participants planned, started 2022-08-03 and due to reach its primary completion in 2027-04. Interventions recorded: D3S-001, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed and Cetuximab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05410145","url":"https://clinicaltrials.gov/study/NCT05410145"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","cisplatin","carboplatin","pemetrexed","cetuximab"],"companies":["d3-bio-wuxi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05410145","phase":"1/2","setting":"A Phase 1/2, Open Label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation","sponsor":"D3 Bio (Wuxi) Co., Ltd","started":"2022-08-03","startedType":"actual","enrolled":442,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06978400","kind":"trial","name":"A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Blokhin's Russian Cancer Research Center, now recruiting.","summary":"A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06978400 by Blokhin's Russian Cancer Research Center, with a registry enrolment figure of 64 participants, started 2025-03-01 and due to reach its primary completion in 2027-11-10. Interventions recorded: mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy. Conditions listed: Neoplasms. Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed colorectal adenocarcinoma that contains MSS and BRAF V600E mutation\". Sites: Russia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06978400","url":"https://clinicaltrials.gov/study/NCT06978400"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","braf-v600e-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06978400","phase":"2","setting":"Non-randomised, Multicentre, Prospective, Single-arm, Phase II Study of the Efficacy and Toxicity of a Combination of FOLFOX With Dabrafenib and Cetuximab/Panitumumab in the First Line of Therapy of Patients With Metastatic BRAF V600E- Mutated MSS Colorectal Cancer","sponsor":"Blokhin's Russian Cancer Research Center","started":"2025-03-01","startedType":"actual","enrolled":64,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05438043","kind":"trial","name":"A Study of Daratumumab","aka":[],"tldr":"A phase 3 trial of Daratumumab, Carfilzomib, Dexamethasone in multiple myeloma, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Daratumumab is a phase 3 interventional study registered as NCT05438043 by Janssen Research & Development, LLC, with 213 participants enrolled, started 2022-12-15 and due to reach its primary completion in 2029-01-31. Interventions recorded: Daratumumab, Carfilzomib, Dexamethasone, Lenalidomide, Pomalidomide. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05438043","url":"https://clinicaltrials.gov/study/NCT05438043"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["daratumumab","carfilzomib","dexamethasone","lenalidomide","pomalidomide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05438043","phase":"3","setting":"A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study","sponsor":"Janssen Research & Development, LLC","started":"2022-12-15","startedType":"actual","enrolled":213,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05460273","kind":"trial","name":"A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)","aka":["TROPION-PanTumor02"],"tldr":"A phase 1/2 trial of Datopotamab deruxtecan in non-small-cell lung cancer and triple-negative breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02) is a phase 1/2 interventional study registered as NCT05460273 by AstraZeneca, with 119 participants enrolled, started 2022-07-11 and due to reach its primary completion in 2023-11-07. Interventions recorded: Datopotamab Deruxtecan (Dato-DXd). Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05460273","url":"https://clinicaltrials.gov/study/NCT05460273"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","tnbc","tnbc-metastatic"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05460273","phase":"1/2","setting":"Phase 1/2, Multicentre, Open-label, Multiple-cohort Study of Dato-DXd in Chinese Patients With Advanced Non-small-cell Lung Cancer, Triple-negative Breast Cancer, Gastric/Gastroesophageal Junction Cancer, Urothelial Cancer, and Other Solid Tumours (TROPION-PanTumor02)","sponsor":"AstraZeneca","started":"2022-07-11","startedType":"actual","yearReported":2025,"enrolled":119,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed Objective Response Rate(ORR) Assessed by Independent Central Review(ICR)","primary":true,"unit":"%","arms":[{"name":"TNBC Cohort","n":77,"value":33.8,"note":"95% CI 23.4 to 45.4; Figures from the ClinicalTrials.gov results section (first posted 2025-06-13), not from a publication"},{"name":"NSCLC Cohort","n":40,"value":45,"note":"95% CI 29.3 to 61.5"}],"source":"https://clinicaltrials.gov/study/NCT05460273?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"TNBC Cohort","n":79,"value":13.5,"note":"95% CI 10.7 to NA; Figures from the ClinicalTrials.gov results section (first posted 2025-06-13), not from a publication"},{"name":"NSCLC Cohort","n":40,"value":16.7,"note":"95% CI 13.8 to 20.4"}],"source":"https://clinicaltrials.gov/study/NCT05460273?tab=results"}]},{"id":"nct07205822","kind":"trial","name":"A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer","aka":["TROPION-Breast06"],"tldr":"A phase 3 trial of Dato-DXd in HR-positive / HER2-negative breast cancer, run by AstraZeneca, now recruiting.","summary":"A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer is a phase 3 interventional study registered as NCT07205822 by AstraZeneca, with 100 participants planned, started 2025-10-30 and due to reach its primary completion in 2028-02-02. Interventions recorded: Dato-DXd.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07205822","url":"https://clinicaltrials.gov/study/NCT07205822"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07205822","phase":"3","setting":"A Phase IIIb, Open-label, Multinational Study Assessing the Efficacy and Safety of Dato-DXd Treatment in Patients With HRpositive, HER2 IHC 0, Locally Advanced Inoperable or Metastatic Breast Cancer Refractory to Endocrine Therapy (TROPION-Breast06)","sponsor":"AstraZeneca","started":"2025-10-30","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06018337","kind":"trial","name":"A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Bre","aka":["DYNASTY-Breast02"],"tldr":"A phase 3 trial of Trastuzumab pamirtecan run by DualityBio Inc., active.","summary":"A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) is a phase 3 interventional study registered as NCT06018337 by DualityBio Inc., with 541 participants enrolled, started 2024-01-18. Conditions listed: Metastatic Breast Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06018337","url":"https://clinicaltrials.gov/study/NCT06018337"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive","her2-low-metastatic-breast-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-pamirtecan"],"companies":["dualitybio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06018337","phase":"3","setting":"A Phase 3, Randomized, Multi-center, Open-Label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-Low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02)","sponsor":"DualityBio Inc.","started":"2024-01-18","startedType":"actual","enrolled":541,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05785741","kind":"trial","name":"A Study of DB-1310 in Advanced/Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Trastuzumab, Osimertinib and Capecitabine in advanced solid tumours, run by DualityBio Inc., now recruiting.","summary":"A Study of DB-1310 in Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05785741 by DualityBio Inc., with 1000 participants planned, started 2023-08-17 and due to reach its primary completion in 2027-12-30. Interventions recorded: DB-1310, Trastuzumab, Osimertinib and capecitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05785741","url":"https://clinicaltrials.gov/study/NCT05785741"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["trastuzumab","osimertinib","capecitabine"],"companies":["dualitybio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05785741","phase":"1/2","setting":"A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1310 in Subjects With Advanced/Metastatic Solid Tumors","sponsor":"DualityBio Inc.","started":"2023-08-17","startedType":"actual","enrolled":1000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07263594","kind":"trial","name":"A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors","aka":[],"tldr":"A phase 1/2 trial of DB-1324 in advanced solid tumours, run by DualityBio Inc., now recruiting.","summary":"A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors is a phase 1/2 interventional study registered as NCT07263594 by DualityBio Inc., with 127 participants planned, started 2026-01-20 and due to reach its primary completion in 2028-12. Interventions recorded: DB-1324.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07263594","url":"https://clinicaltrials.gov/study/NCT07263594"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["dualitybio","gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07263594","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1324 in Participants With Advanced/Metastatic Gastrointestinal Tumors","sponsor":"DualityBio Inc.","started":"2026-01-20","startedType":"actual","enrolled":127,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06873555","kind":"trial","name":"A Study of DC05F01 in Chinese Patients With Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of DC05F01 in ovarian cancer and small-cell lung cancer, run by Heronova Pharmaceuticals, now recruiting.","summary":"A Study of DC05F01 in Chinese Patients With Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06873555 by Heronova Pharmaceuticals, with 60 participants planned, started 2024-09-11 and due to reach its primary completion in 2027-12. Interventions recorded: DC05F01.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06873555","url":"https://clinicaltrials.gov/study/NCT06873555"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06873555","phase":"1/2","setting":"Phase Ib/IIa Multicenter, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of DC05F01 in Patients With Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors","sponsor":"Heronova Pharmaceuticals","started":"2024-09-11","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05765812","kind":"trial","name":"A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma","aka":[],"tldr":"A phase 1/2 trial of Temozolomide in glioma & glioblastoma, run by Debiopharm International SA, now recruiting.","summary":"A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma is a phase 1/2 interventional study registered as NCT05765812 by Debiopharm International SA, with 116 participants planned, started 2023-05-15 and due to reach its primary completion in 2028-09. Interventions recorded: Debio 0123, Temozolomide and Radiotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05765812","url":"https://clinicaltrials.gov/study/NCT05765812"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":["debiopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05765812","phase":"1/2","setting":"A Phase 1/2 Open-label Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma","sponsor":"Debiopharm International SA","started":"2023-05-15","startedType":"actual","enrolled":116,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07807800","kind":"trial","name":"A Study of DES-1357 in People With Deficient Mismatch Repair (dMMR)/Microsatellite Instability-High (MSI-H) Metastatic Colorectal Cancer (mCRC)","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by D. E. Shaw Research, LLC, not yet recruiting.","summary":"A Study of DES-1357 in People With Deficient Mismatch Repair (dMMR)/Microsatellite Instability-High (MSI-H) Metastatic Colorectal Cancer (mCRC) is a phase 1/2, randomised interventional study registered as NCT07807800 by D. E. Shaw Research, LLC, with a registry enrolment figure of 88 participants, started 2026-12-03 and due to reach its primary completion in 2028-07-02. Interventions recorded: DES-1357. Conditions listed: Metastatic Colorectal Cancer (CRC). Primary outcome: Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs); Part 2: Incidence and Severity of Treatment- related Treatment Emergent Adverse Events (TEAEs) Through at least 3 Cycles of DES-1357; Part 2: Best Overall Response (BOR). Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed carcinoma of the colon and/or rectum deemed unresectable and/or with evidence of metastases, that has been cytologically or genetically confirmed as dMMR, and/or MSI-H\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07807800","url":"https://clinicaltrials.gov/study/NCT07807800"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07807800","phase":"1/2","setting":"A Phase 1/2 Adaptive Study of DES-1357 in Participants With Deficient Mismatch Repair (dMMR) and/or Microsatellite Instability-High (MSI-H) Metastatic Colorectal Cancer (mCRC)","sponsor":"D. E. Shaw Research, LLC","started":"2026-12-03","startedType":"estimated","enrolled":88,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02151084","kind":"trial","name":"A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer","aka":[],"tldr":"A phase 2 trial of gemcitabine, cisplatin and selumetinib in gallbladder cancer and other biliary tract cancers, run by University Health Network, Toronto, active and no longer recruiting.","summary":"A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer is a phase 2, randomised interventional study registered as NCT02151084 by University Health Network, Toronto, with a registry enrolment figure of 57 participants, started 2014-11 and due to reach its primary completion in 2027-05. Interventions recorded: Selumetinib, Cisplatin, Gemcitabine. Conditions listed: Biliary Tract Carcinoma, Gallbladder Carcinoma. Sites: Canada. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02151084","url":"https://clinicaltrials.gov/study/NCT02151084"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","kinase-inhibitors"],"targets":[],"drugs":["gemcitabine","cisplatin","selumetinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02151084","phase":"2","setting":"A Randomized Phase II Trial of MEK Inhibitor Selumetinib (AZD6244) Combined Continuously or Sequentially With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Patients With Advanced Biliary Cancer","sponsor":"University Health Network, Toronto","started":"2014-11","startedType":"actual","enrolled":57,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06577025","kind":"trial","name":"A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Ind","aka":[],"tldr":"A phase 2 trial of Ciltacabtagene autoleucel, Talquetamab, Daratumumab in multiple myeloma, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma is a phase 2 interventional study registered as NCT06577025 by Janssen Research & Development, LLC, with 43 participants enrolled, started 2024-08-20 and due to reach its primary completion in 2030-09-02. Interventions recorded: Cilta-cel, Talquetamab, Daratumumab, Teclistamab, Bortezomib. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06577025","url":"https://clinicaltrials.gov/study/NCT06577025"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["car-t","kinase-inhibitors","monoclonal-antibody","protac-degrader","t-cell-engager"],"targets":[],"drugs":["ciltacabtagene-autoleucel","talquetamab","daratumumab","teclistamab","bortezomib","lenalidomide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06577025","phase":"2","setting":"A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Different Sequences of Ciltacabtagene Autoleucel (Cilta-cel), Talquetamab SC in Combination With Daratumumab SC (Tal-D) and Teclistamab SC in Combination With Daratumumab SC (Tec-D) Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Participants With Standard-risk Newly Diagnosed Multiple Myeloma","sponsor":"Janssen Research & Development, LLC","started":"2024-08-20","startedType":"actual","enrolled":43,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04879329","kind":"trial","name":"A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2","aka":[],"tldr":"A phase 2 trial of Disitamab vedotin and Pembrolizumab in bladder & urothelial cancer, run by Seagen, a wholly owned subsidiary of Pfizer, now recruiting.","summary":"A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2 is a phase 2 interventional study registered as NCT04879329 by Seagen, a wholly owned subsidiary of Pfizer, with 372 participants planned, started 2022-05-03 and due to reach its primary completion in 2026-12-11. Interventions recorded: disitamab vedotin and pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04879329","url":"https://clinicaltrials.gov/study/NCT04879329"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["disitamab-vedotin","pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04879329","phase":"2","setting":"A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2","sponsor":"Seagen, a wholly owned subsidiary of Pfizer","started":"2022-05-03","startedType":"actual","enrolled":372,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07315750","kind":"trial","name":"A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.","aka":[],"tldr":"A phase 3 trial of Disitamab vedotin, Tislelizumab, Capecitabine, Oxaliplatin, Trastuzumab and Pembrolizumab in gastric & gastro-oesophageal junction cancer, run by RemeGen Co., Ltd., now recruiting.","summary":"A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. is a phase 3 interventional study registered as NCT07315750 by RemeGen Co., Ltd., with 555 participants planned, started 2026-01-01 and due to reach its primary completion in 2029-06-30. Interventions recorded: Disitamab Vedotin, Tislelizumab, CAPOX (oxaliplatin/capecitabine), Trastuzumab and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07315750","url":"https://clinicaltrials.gov/study/NCT07315750"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["adc","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["disitamab-vedotin","tislelizumab","capecitabine","oxaliplatin","trastuzumab","pembrolizumab"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07315750","phase":"3","setting":"A Randomized Controlled Phase III Study to Evaluate the Combination of Disitamab Vedotin, Trastuzumab, and Tislelizumab Versus Chemotherapy (CAPOX) Combined With Trastuzumab With or Without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma With HER2-high Expression","sponsor":"RemeGen Co., Ltd.","started":"2026-01-12","startedType":"actual","enrolled":555,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06966453","kind":"trial","name":"A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of Disitamab vedotin in advanced solid tumours, run by Pfizer, active and no longer recruiting.","summary":"A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer is a phase 1/2 interventional study registered as NCT06966453 by Pfizer, with 74 participants enrolled, started 2025-06-30 and due to reach its primary completion in 2027-10-25. Interventions recorded: Disitamab vedotin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06966453","url":"https://clinicaltrials.gov/study/NCT06966453"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["disitamab-vedotin"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06966453","phase":"1/2","setting":"A PHASE 1B/2, OPEN-LABEL, MULTICOHORT STUDY OF DISITAMAB VEDOTIN IN ADULTS WITH HER2 EXPRESSING ADVANCED BREAST CANCER","sponsor":"Pfizer","started":"2025-06-30","startedType":"actual","enrolled":74,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06003231","kind":"trial","name":"A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2","aka":[],"tldr":"A phase 2 trial of Disitamab vedotin in non-small-cell lung cancer, ovarian cancer, endometrial cancer and head and neck squamous cell carcinoma, run by Seagen, a wholly owned subsidiary of Pfizer, active and no longer recruiting.","summary":"A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2 is a phase 2 interventional study registered as NCT06003231 by Seagen, a wholly owned subsidiary of Pfizer, with 120 participants enrolled, started 2023-11-14 and due to reach its primary completion in 2026-03-27. Interventions recorded: disitamab vedotin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06003231","url":"https://clinicaltrials.gov/study/NCT06003231"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","ovarian","endometrial","head-and-neck","her2-mutant-nsclc"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["disitamab-vedotin"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06003231","phase":"2","setting":"A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects With Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2","sponsor":"Seagen, a wholly owned subsidiary of Pfizer","started":"2023-11-14","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06157892","kind":"trial","name":"A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors","aka":[],"tldr":"A phase 2 trial of Disitamab vedotin and Tucatinib in gastric & gastro-oesophageal junction cancer, HER2-positive breast cancer and triple-negative breast cancer, run by Seagen, a wholly owned subsidiary of Pfizer, active and no longer recruiting.","summary":"A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors is a phase 2 interventional study registered as NCT06157892 by Seagen, a wholly owned subsidiary of Pfizer, with 54 participants enrolled, started 2024-05-20 and due to reach its primary completion in 2029-07-28. Interventions recorded: disitamab vedotin and tucatinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06157892","url":"https://clinicaltrials.gov/study/NCT06157892"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","breast-her2-positive","tnbc"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["disitamab-vedotin","tucatinib"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06157892","phase":"2","setting":"A Phase 1b/2 Open-Label Study of Disitamab Vedotin in Combination With Other Anticancer Therapies in Solid Tumors","sponsor":"Seagen, a wholly owned subsidiary of Pfizer","started":"2024-05-20","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06751329","kind":"trial","name":"A Study of DM002 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of DM002 in ovarian cancer, prostate cancer, endometrial cancer, colorectal cancer and pancreatic ductal adenocarcinoma, run by Xadcera Biopharmaceutical (Suzhou) Co., Ltd., now recruiting.","summary":"A Study of DM002 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06751329 by Xadcera Biopharmaceutical (Suzhou) Co., Ltd., with 280 participants planned, started 2025-02-17 and due to reach its primary completion in 2027-10-08. Interventions recorded: DM002.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06751329","url":"https://clinicaltrials.gov/study/NCT06751329"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","prostate","endometrial","colorectal","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06751329","phase":"1/2","setting":"A Phase I/IIa, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM002 in Patients With Advanced Solid Tumors","sponsor":"Xadcera Biopharmaceutical (Suzhou) Co., Ltd.","started":"2025-02-17","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06515990","kind":"trial","name":"A Study of DM005 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of DM005 in non-small-cell lung cancer and head and neck squamous cell carcinoma, run by Doma Biopharmaceutical（Suzhou）Co., Ltd., now recruiting.","summary":"A Study of DM005 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06515990 by Doma Biopharmaceutical（Suzhou）Co., Ltd., with 208 participants planned, started 2024-10-31 and due to reach its primary completion in 2027-03. Interventions recorded: DM005.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06515990","url":"https://clinicaltrials.gov/study/NCT06515990"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06515990","phase":"1/2","setting":"A Phase I/IIa, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients With Advanced Solid Tumors","sponsor":"Doma Biopharmaceutical（Suzhou）Co., Ltd.","started":"2024-10-31","startedType":"actual","enrolled":208,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06492941","kind":"trial","name":"A Study of Docetaxel for Injection (Albumin Bound) in Patients With Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial in pancreatic cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., not yet recruiting.","summary":"A Study of Docetaxel for Injection (Albumin Bound) in Patients With Advanced Pancreatic Cancer is a phase 3, randomised interventional study registered as NCT06492941 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., with a registry enrolment figure of 142 participants, started 2024-08-12 and due to reach its primary completion in 2026-04-14. Interventions recorded: Docetaxel for Injection (Albumin bound); Placebo; Best supportive care. Conditions listed: Advanced Pancreatic Cancer. Primary outcome: OS. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed diagnosis of pancreatic cancer (including adenosquamous carcinoma)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06492941","url":"https://clinicaltrials.gov/study/NCT06492941"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06492941","phase":"3","setting":"A Randomized, Double-blind, Multicenter Phase III Clinical Study of Docetaxel for Injection (Albumin Bound) Combined With Best Supportive Care Versus Placebo Plus Best Supportive Care in Advanced Pancreatic Cancer","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","started":"2024-08-12","startedType":"estimated","enrolled":142,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07108270","kind":"trial","name":"A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC)","aka":["China RUBY"],"tldr":"A phase 2 trial of Dostarlimab and Carboplatin in endometrial cancer, run by GlaxoSmithKline, now recruiting.","summary":"A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC) is a phase 2 interventional study registered as NCT07108270 by GlaxoSmithKline, with 30 participants planned, started 2025-11-27 and due to reach its primary completion in 2030-03-31. Interventions recorded: Dostarlimab, Carboplatin and Paclitaxel.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07108270","url":"https://clinicaltrials.gov/study/NCT07108270"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer","endometrial-mmr-deficient"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["dostarlimab","carboplatin"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07108270","phase":"2","setting":"A Phase 2, Multicenter, Open-label, Single Arm Study of Dostarlimab Plus Carboplatin-paclitaxel Followed by Dostarlimab Monotherapy in Participants With dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer in China (China RUBY)","sponsor":"GlaxoSmithKline","started":"2025-11-27","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06317311","kind":"trial","name":"A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer","aka":["RUBY-J"],"tldr":"A phase 2 trial of Dostarlimab and Carboplatin in advanced solid tumours, run by GlaxoSmithKline, active and no longer recruiting.","summary":"A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer is a phase 2 interventional study registered as NCT06317311 by GlaxoSmithKline, with 41 participants enrolled, started 2024-05-07 and due to reach its primary completion in 2026-07-15. Interventions recorded: Dostarlimab, Carboplatin and Paclitaxel.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06317311","url":"https://clinicaltrials.gov/study/NCT06317311"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["dostarlimab","carboplatin"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06317311","phase":"2","setting":"A Phase 2, Multicenter, Open-label, Single Arm Study of Dostarlimab Plus Carboplatin-paclitaxel Followed by Dostarlimab Monotherapy in Japanese Patients With Primary Advanced or Recurrent Endometrial Cancer (RUBY-J)","sponsor":"GlaxoSmithKline","started":"2024-05-07","startedType":"actual","enrolled":41,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06640049","kind":"trial","name":"A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China","aka":["China AZUR-1"],"tldr":"A phase 2 trial of Dostarlimab in colorectal cancer, run by GlaxoSmithKline, active and no longer recruiting.","summary":"A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China is a phase 2 interventional study registered as NCT06640049 by GlaxoSmithKline, with 23 participants enrolled, started 2024-10-17 and due to reach its primary completion in 2027-10-24. Interventions recorded: Dostarlimab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06640049","url":"https://clinicaltrials.gov/study/NCT06640049"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","msi-high-colorectal","rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06640049","phase":"2","setting":"A Phase 2, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer in China","sponsor":"GlaxoSmithKline","started":"2024-10-17","startedType":"actual","enrolled":23,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06256588","kind":"trial","name":"A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma","aka":["JADE"],"tldr":"A phase 3 trial of Dostarlimab in head and neck squamous cell carcinoma, run by GlaxoSmithKline, now recruiting.","summary":"A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma is a phase 3 interventional study registered as NCT06256588 by GlaxoSmithKline, with 864 participants planned, started 2024-03-21 and due to reach its primary completion in 2028-06-30. Interventions recorded: Dostarlimab and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06256588","url":"https://clinicaltrials.gov/study/NCT06256588"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","hpv-negative-head-and-neck-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06256588","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Dostarlimab as Sequential Therapy After Chemoradiation in Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma","sponsor":"GlaxoSmithKline","started":"2024-03-21","startedType":"actual","enrolled":864,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05475925","kind":"trial","name":"A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas","aka":[],"tldr":"A phase 1/2 trial of DR-01 in peripheral T-cell lymphomas, run by Dren Bio, now recruiting.","summary":"A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas is a phase 1/2 interventional study registered as NCT05475925 by Dren Bio, with 200 participants planned, started 2022-07-13 and due to reach its primary completion in 2026-12. Interventions recorded: DR-01.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05475925","url":"https://clinicaltrials.gov/study/NCT05475925"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["dr-01"],"companies":["dren-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05475925","phase":"1/2","setting":"A Multicenter, Open-Label, First-In-Human, Multiple Expansion Cohort, Phase 1/2 Study to Evaluate the Safety and Efficacy of DR-01 in Adult Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas","sponsor":"Dren Bio","started":"2022-07-13","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04458272","kind":"trial","name":"A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma","aka":[],"tldr":"A phase 2 trial of Safusidenib in glioma & glioblastoma, run by Daiichi Sankyo Co., Ltd., active and no longer recruiting.","summary":"A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma is a phase 2 interventional study registered as NCT04458272 by Daiichi Sankyo Co., Ltd., with 25 participants enrolled, started 2020-07-08 and due to reach its primary completion in 2023-03-10. Interventions recorded: DS-1001b.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04458272","url":"https://clinicaltrials.gov/study/NCT04458272"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma","idh-mutant-astrocytoma"],"sections":[],"technologies":[],"targets":[],"drugs":["safusidenib"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04458272","phase":"2","setting":"A Phase II Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-naive IDH1 Mutated WHO Grade II Glioma","sponsor":"Daiichi Sankyo Co., Ltd.","started":"2020-07-08","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07739966","kind":"trial","name":"A Study of DS-3939a in Participants With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of pembrolizumab, carboplatin and pemetrexed in lung cancer, run by Daiichi Sankyo, not yet recruiting.","summary":"A Study of DS-3939a in Participants With Solid Tumors is a phase 1/2, interventional study registered as NCT07739966 by Daiichi Sankyo, with a registry enrolment figure of 400 participants, started 2026-10-01 and due to reach its primary completion in 2030-07-31. Interventions recorded: DS-3939a; Pembrolizumab; Carboplatin; Pemetrexed; DS-1103a. Conditions listed: Solid Tumor; Locally Advanced Non-Small Cell Lung Cancer; Metastatic Non-Small Cell Lung Cancer. Primary outcome: Part 1: Number of Participants With Dose-limiting Toxicities (DLTs); Part 1: Number of Participants With TEAEs; Part 2: Objective Response (OR) Per RECIST v1.1 as Assessed by Investigator. Lung eligibility wording from the registry: \"Histologically documented Stage IIIB, IIIC disease who is not candidate for surgical resection or definitive chemoradiation, or Stage IV NSQ NSCLC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07739966","url":"https://clinicaltrials.gov/study/NCT07739966"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pembrolizumab","carboplatin","pemetrexed"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07739966","phase":"1/2","setting":"A Phase 1b/2, Multicenter, 2-part, Open-label Trial to Evaluate DS-3939a in Participants With Solid Tumors","sponsor":"Daiichi Sankyo","started":"2026-10-01","startedType":"estimated","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04440735","kind":"trial","name":"A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Atezolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Kahr Medical, active and no longer recruiting.","summary":"A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT04440735 by Kahr Medical, with 125 participants planned, started 2020-10-07 and due to reach its primary completion in 2025-09. Interventions recorded: DSP107, Atezolizumab. Conditions listed: Advanced Solid Tumor, Non Small Cell Lung Cancer, Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04440735","url":"https://clinicaltrials.gov/study/NCT04440735"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04440735","phase":"1/2","setting":"A First-in-Human, Two-Part, Open-Label, Phase I/II Study of DSP107 in Subjects with Advanced Solid Tumors Including a Dose-escalation Safety Study (part 1) and Preliminary Efficacy Assessment of DSP107 As Monotherapy and in Combination with Atezolizumab (part 2)","sponsor":"Kahr Medical","started":"2020-10-07","startedType":"actual","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02671435","kind":"trial","name":"A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Monalizumab, Durvalumab, Cetuximab, FOLFOX (5-FU, leucovorin, oxaliplatin) and Bevacizumab in advanced solid tumours, run by MedImmune LLC, active and no longer recruiting.","summary":"A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors is a phase 1/2 interventional study registered as NCT02671435 by MedImmune LLC, with 383 participants enrolled, started 2016-02-22 and due to reach its primary completion in 2021-10-26. Interventions recorded: Monalizumab, Durvalumab, Cetuximab, mFOLFOX6 and Bevacizumab. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02671435","url":"https://clinicaltrials.gov/study/NCT02671435"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["monalizumab","durvalumab","cetuximab","folfox","bevacizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02671435","phase":"1/2","setting":"A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumors","sponsor":"MedImmune LLC","started":"2016-02-22","startedType":"actual","yearReported":2023,"enrolled":383,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Objective Response (OR) in Exploration Cohorts C1A and C1B","primary":true,"unit":"%","arms":[{"name":"Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W","n":40,"value":0,"note":"95% CI 0.0 to 10.3; Figures from the ClinicalTrials.gov results section (first posted 2023-03-09), not from a publication"},{"name":"Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W","n":41,"value":0,"note":"95% CI 0.0 to 9.0"}],"source":"https://clinicaltrials.gov/study/NCT02671435?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W","n":3,"value":15.1,"note":"95% CI NA to NA; Figures from the ClinicalTrials.gov results section (first posted 2023-03-09), not from a publication"},{"name":"Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W","n":3,"value":20.1,"note":"95% CI 18.6 to NA"},{"name":"Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W","n":3,"note":"Median and limits of 95% CI could not be derived due to insufficient events being observed."},{"name":"Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W","n":18,"value":8.1,"note":"95% CI 4.0 to 16.7"},{"name":"Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W","n":18,"value":13.4,"note":"95% CI 4.4 to 16.9"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC)","n":40,"value":10.6,"note":"95% CI 6.0 to 20.1"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian)","n":40,"value":16.7,"note":"95% CI 10.7 to 21.4"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS)","n":40,"value":11,"note":"95% CI 6.7 to 17.3"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC)","n":20,"value":8.8,"note":"95% CI 5.8 to 15.6"},{"name":"Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W","n":18,"value":25.6,"note":"95% CI 13.8 to NA"},{"name":"Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W","n":18,"value":29.6,"note":"95% CI 19.8 to NA"}],"source":"https://clinicaltrials.gov/study/NCT02671435?tab=results"},{"endpoint":"Progression-Free Survival (PFS)","unit":"months","arms":[{"name":"Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W","n":3,"value":1.8,"note":"95% CI 1.7 to NA; Figures from the ClinicalTrials.gov results section (first posted 2023-03-09), not from a publication"},{"name":"Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W","n":3,"value":1.9,"note":"95% CI 1.8 to NA"},{"name":"Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W","n":3,"value":1.9,"note":"95% CI NA to NA"},{"name":"Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W","n":18,"value":2,"note":"95% CI 1.7 to 3.4"},{"name":"Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W","n":18,"value":1.8,"note":"95% CI 1.7 to 3.5"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC)","n":40,"value":1.9,"note":"95% CI 1.8 to 3.6"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian)","n":40,"value":1.8,"note":"95% CI 1.7 to 1.9"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS)","n":40,"value":1.8,"note":"95% CI 1.7 to 3.3"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC)","n":20,"value":1.9,"note":"95% CI 1.7 to 3.7"},{"name":"Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W","n":18,"value":10.9,"note":"95% CI 5.7 to 17.7"},{"name":"Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W","n":18,"value":14.7,"note":"95% CI 5.8 to 20.9"}],"source":"https://clinicaltrials.gov/study/NCT02671435?tab=results"}]},{"id":"nct03459846","kind":"trial","name":"A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)","aka":["BAYOU"],"tldr":"A phase 2 trial of Durvalumab and Olaparib in bladder & urothelial cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU) is a phase 2 interventional study registered as NCT03459846 by AstraZeneca, with 154 participants enrolled, started 2018-03-16 and due to reach its primary completion in 2020-10-15. Interventions recorded: Durvalumab, Olaparib and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03459846","url":"https://clinicaltrials.gov/study/NCT03459846"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["durvalumab","olaparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03459846","phase":"2","setting":"A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer","sponsor":"AstraZeneca","started":"2018-03-16","startedType":"actual","yearReported":2022,"enrolled":154,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Durva + Olaparib","n":78,"value":4.2,"note":"95% CI 3.6 to 5.6; Figures from the ClinicalTrials.gov results section (first posted 2022-10-26), not from a publication"},{"name":"Durva + Placebo","n":76,"value":3.5,"note":"95% CI 1.9 to 5.1"}],"hr":0.94,"ci":[0.641,1.387],"p":"0.789","source":"https://clinicaltrials.gov/study/NCT03459846?tab=results"}]},{"id":"nct03706690","kind":"trial","name":"A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients","aka":["PACIFIC-5"],"tldr":"A phase 3 trial of Durvalumab in non-small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients is a phase 3 interventional study registered as NCT03706690 by AstraZeneca, with 407 participants enrolled, started 2018-11-27 and due to reach its primary completion in 2024-06-23. Interventions recorded: Durvalumab. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03706690","url":"https://clinicaltrials.gov/study/NCT03706690"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03706690-j-hematol-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03706690","phase":"3","setting":"A Phase III, Randomised,Double-Blind,Placebo-Controlled,Study of Durvalumab as Consolidation Therapy in Patients With Locally Advanced,Unresectable NSCLC, Who Have Not Progressed Following Definitive, Platinum-Based Chemoradiation Therapy","sponsor":"AstraZeneca","started":"2018-11-27","startedType":"actual","yearReported":2025,"enrolled":407,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Free Survival (PFS) (Modified Intent-to-Treat [mITT] Set)","primary":true,"unit":"months","arms":[{"name":"Durvalumab","n":252,"value":14,"note":"95% CI 10.9 to 18.0; Figures from the ClinicalTrials.gov results section (first posted 2025-02-12), not from a publication"},{"name":"Placebo","n":129,"value":6.5,"note":"95% CI 5.4 to 13.8"}],"hr":0.75,"ci":[0.578,0.986],"p":"0.038","source":"https://clinicaltrials.gov/study/NCT03706690?tab=results"},{"endpoint":"Overall Survival (OS), ITT set","unit":"months","arms":[{"name":"Durvalumab","n":272,"value":38.4,"note":"95% CI 29.0 to 42.9; Figures from the ClinicalTrials.gov results section (first posted 2025-02-12), not from a publication"},{"name":"Placebo","n":135,"value":32.5,"note":"95% CI 20.6 to 40.4"}],"hr":0.87,"ci":[0.656,1.166],"p":"0.346","source":"https://clinicaltrials.gov/study/NCT03706690?tab=results"},{"endpoint":"Objective Response Rate (ORR), ITT set","unit":"%","arms":[{"name":"Durvalumab","n":240,"value":27.1,"note":"Figures from the ClinicalTrials.gov results section (first posted 2025-02-12), not from a publication"},{"name":"Placebo","n":127,"value":19.7}],"p":"0.128","source":"https://clinicaltrials.gov/study/NCT03706690?tab=results"}]},{"id":"nct02519348","kind":"trial","name":"A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma","aka":[],"tldr":"A phase 2 trial of Tremelimumab, Durvalumab, Bevacizumab in hepatocellular carcinoma, run by MedImmune LLC, active and no longer recruiting.","summary":"A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma is a phase 2 interventional study registered as NCT02519348 by MedImmune LLC, with 433 participants enrolled, started 2015-10-19 and due to reach its primary completion in 2020-11-06. Interventions recorded: Tremelimumab, Durvalumab, Bevacizumab. Conditions listed: Hepatocellular Carcinoma. Results were posted on ClinicalTrials.gov in 2021; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02519348","url":"https://clinicaltrials.gov/study/NCT02519348"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["tremelimumab","durvalumab","bevacizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02519348","phase":"2","setting":"A Study of Safety, Tolerability, and Clinical Activity of Durvalumab and Tremelimumab Administered as Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Subjects With Advanced Hepatocellular Carcinoma","sponsor":"MedImmune LLC","started":"2015-10-19","startedType":"actual","yearReported":2021,"enrolled":433,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Dose Limiting Toxicities (DLTs)","primary":true,"unit":"participants","arms":[{"name":"Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg","n":16,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2021-12-06), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT02519348?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg","n":40,"value":12.58,"note":"95% CI 6.87 to 20.99; Figures from the ClinicalTrials.gov results section (first posted 2021-12-06), not from a publication"},{"name":"Parts 2 and 3: Durvalumab 1500 mg","n":104,"value":12.91,"note":"95% CI 8.74 to 16.79"},{"name":"Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg","n":75,"value":17.05,"note":"95% CI 10.55 to 22.83"},{"name":"Parts 2 and 3: Tremelimumab 750 mg","n":69,"value":17.05,"note":"95% CI 11.33 to 20.24"},{"name":"Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg","n":84,"value":11.3,"note":"95% CI 8.38 to 14.95"},{"name":"Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg","n":47,"note":"Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis."},{"name":"China Cohort: Durvalumab 20 mg/kg","n":3,"value":30.69,"note":"95% CI 13.96 to NA"},{"name":"China Cohort: Tremelimumab 10 mg/kg","n":5,"value":3.52,"note":"95% CI 2.20 to 20.96"},{"name":"China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg","n":6,"value":6.28,"note":"95% CI 0.66 to 23.82"}],"source":"https://clinicaltrials.gov/study/NCT02519348?tab=results"}]},{"id":"nct06522737","kind":"trial","name":"A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype","aka":["TERZO"],"tldr":"A phase 3 trial of Duvelisib, Gemcitabine and Bendamustine in non-Hodgkin lymphoma, run by SecuraBio, now recruiting.","summary":"A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype is a phase 3 interventional study registered as NCT06522737 by SecuraBio, with 124 participants planned, started 2025-05-19 and due to reach its primary completion in 2028-02. Interventions recorded: Duvelisib, Gemcitabine and Bendamustine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06522737","url":"https://clinicaltrials.gov/study/NCT06522737"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["duvelisib","gemcitabine","bendamustine"],"companies":["securabio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06522737","phase":"3","setting":"A Multicentre, Open-label, Phase 3, Randomised Controlled Trial of Duvelisib Versus Investigator's Choice of Gemcitabine or Bendamustine in Patients With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype","sponsor":"SecuraBio","started":"2025-05-19","startedType":"actual","enrolled":124,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07559929","kind":"trial","name":"A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer.","aka":[],"tldr":"A phase 1/2 trial of toripalimab, carboplatin and cisplatin in lung cancer, run by Hangzhou DAC Biotechnology Co., Ltd., now recruiting.","summary":"A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer. is a phase 1/2, interventional study registered as NCT07559929 by Hangzhou DAC Biotechnology Co., Ltd., with a registry enrolment figure of 200 participants, started 2026-08-19 and due to reach its primary completion in 2028-06-01. Interventions recorded: DXC006; Toripalimab; Carboplatin; Cisplatin. Conditions listed: Small Cell Lung Cancer. Primary outcome: Progression Free Survival (PFS); 6-month progression-free survival rate; Recommended Phase 2 Dose (RP2D). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed small cell lung cancer (SCLC)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07559929","url":"https://clinicaltrials.gov/study/NCT07559929"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["toripalimab","carboplatin","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07559929","phase":"1/2","setting":"A Phase Ib/II Study to Evaluate the Safety and Efficacy of DXC006 for Injection Combined With Immune Checkpoint Inhibitors or Platinum-Based Agents in Patients With Small Cell Lung Cancer.","sponsor":"Hangzhou DAC Biotechnology Co., Ltd.","started":"2026-08-19","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07154264","kind":"trial","name":"A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)","aka":["TAI-SHAN10"],"tldr":"A phase 2 trial of DZD8586 and Venetoclax in chronic lymphocytic leukaemia, run by Dizal Pharmaceuticals, now recruiting.","summary":"A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10) is a phase 2 interventional study registered as NCT07154264 by Dizal Pharmaceuticals, with 66 participants planned, started 2025-09-22 and due to reach its primary completion in 2029-12. Interventions recorded: DZD8586 and Venetoclax.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07154264","url":"https://clinicaltrials.gov/study/NCT07154264"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll"],"sections":[],"technologies":[],"targets":[],"drugs":["dzd8586","venetoclax"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07154264","phase":"2","setting":"A Phase 2 Study of DZD8586 Combination Therapy in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)","sponsor":"Dizal Pharmaceuticals","started":"2025-09-22","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"tai-shan6","kind":"trial","name":"A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)","aka":["TAI-SHAN6"],"tldr":"A phase 3 trial testing DZD8586 in chronic lymphocytic leukaemia, now recruiting.","summary":"A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6) is a phase 3 interventional study registered as NCT07139873, led by Dizal Pharmaceuticals, and recruiting on the registry. Official title: A Phase 3, Open-Label, Randomised, Multicenter Study to Evaluate Anti-tumour Efficacy of DZD8586 Versus Investigator's Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma. Planned enrolment is 250 participants (estimated). The study started in 2025-09-08 and primary completion is expected in 2029-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07139873","url":"https://clinicaltrials.gov/study/NCT07139873"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":[],"targets":[],"drugs":["dzd8586"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07139873","phase":"3","setting":"A Phase 3, Open-Label, Randomized, Multicenter Study to Evaluate Anti-tumor Efficacy of DZD8586 Versus Investigator's Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","sponsor":"Dizal Pharmaceuticals","started":"2025-09-08","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05668988","kind":"trial","name":"A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)","aka":["WU-KONG28"],"tldr":"A phase 3 trial of Sunvozertinib, Pemetrexed, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Dizal Pharmaceuticals, active and no longer recruiting.","summary":"A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28) is a phase 3 interventional study registered as NCT05668988 by Dizal Pharmaceuticals, with 324 participants enrolled, started 2022-12-13 and due to reach its primary completion in 2026-01-16. Interventions recorded: sunvozertinib, Pemetrexed+carboplatin. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05668988","url":"https://clinicaltrials.gov/study/NCT05668988"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["sunvozertinib","pemetrexed","carboplatin"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05668988-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05668988","phase":"3","setting":"A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation","sponsor":"Dizal Pharmaceuticals","started":"2022-12-13","startedType":"actual","enrolled":324,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04008797","kind":"trial","name":"A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor","aka":[],"tldr":"A phase 1/2 trial of Lenvatinib and Doxorubicin in endometrial cancer, hepatocellular carcinoma and colorectal cancer, run by Eisai Inc., active and no longer recruiting.","summary":"A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor is a phase 1/2 interventional study registered as NCT04008797 by Eisai Inc., with 301 participants enrolled, started 2019-07-11 and due to reach its primary completion in 2027-03-31. Interventions recorded: E7386, Lenvatinib, Doxorubicin and Paclitaxel.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04008797","url":"https://clinicaltrials.gov/study/NCT04008797"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial","hcc","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["lenvatinib","doxorubicin"],"companies":["eisai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04008797","phase":"1/2","setting":"An Open-label Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors","sponsor":"Eisai Inc.","started":"2019-07-11","startedType":"actual","enrolled":301,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04078295","kind":"trial","name":"A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor","aka":[],"tldr":"A phase 1/2 trial of Nivolumab in advanced solid tumours, run by Eisai Co., Ltd., active and no longer recruiting.","summary":"A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor is a phase 1/2 interventional study registered as NCT04078295 by Eisai Co., Ltd., with 125 participants enrolled, started 2019-09-05 and due to reach its primary completion in 2027-03-31. Interventions recorded: E7389-LF and Nivolumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04078295","url":"https://clinicaltrials.gov/study/NCT04078295"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["eisai","deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04078295","phase":"1/2","setting":"An Open-Label Phase 1b/2 Study of E7389 Liposomal Formulation Plus Nivolumab in Subjects With Solid Tumor","sponsor":"Eisai Co., Ltd.","started":"2019-09-05","startedType":"actual","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05845814","kind":"trial","name":"A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)","aka":["KEYMAKER-U04"],"tldr":"A phase 1/2 trial of Favezelimab and Pembrolizumab in bladder & urothelial cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04) is a phase 1/2 interventional study registered as NCT05845814 by Merck Sharp & Dohme LLC, with 390 participants enrolled, started 2023-06-23 and due to reach its primary completion in 2027-05-31. Interventions recorded: Coformulated favezelimab/pembrolizumab, Coformulated vibostolimab/pembrolizumab, EV and Pembrolizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05845814","url":"https://clinicaltrials.gov/study/NCT05845814"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["favezelimab","pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05845814","phase":"1/2","setting":"A Phase 1/2 Randomized, Umbrella Study to Evaluate the Safety and Efficacy of Pembrolizumab Plus Enfortumab Vedotin (EV) in Combination With Investigational Agents Versus Pembrolizumab Plus EV, as First-Line Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04B","sponsor":"Merck Sharp & Dohme LLC","started":"2023-06-23","startedType":"actual","enrolled":390,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06483334","kind":"trial","name":"A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04)","aka":["KEYMAKER-U04"],"tldr":"A phase 1/2 trial of Sacituzumab tirumotecan, Enfortumab vedotin and Pembrolizumab in bladder & urothelial cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04) is a phase 1/2 interventional study registered as NCT06483334 by Merck Sharp & Dohme LLC, with 38 participants enrolled, started 2024-07-17 and due to reach its primary completion in 2028-03-31. Interventions recorded: Sacituzumab tirumotecan, Enfortumab Vedotin, Pembrolizumab and Supportive care measures.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06483334","url":"https://clinicaltrials.gov/study/NCT06483334"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","enfortumab-vedotin","pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06483334","phase":"1/2","setting":"A Phase 1/2 Randomized, Umbrella Study to Evaluate the Efficacy and Safety of MK-2870 Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab, as Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04C","sponsor":"Merck Sharp & Dohme LLC","started":"2024-07-17","startedType":"actual","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06492616","kind":"trial","name":"A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence","aka":["ELEGANT"],"tldr":"A phase 3 trial of Elacestrant, Exemestane and Tamoxifen in advanced solid tumours, run by Stemline Therapeutics, Inc., now recruiting.","summary":"A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence is a phase 3 interventional study registered as NCT06492616 by Stemline Therapeutics, Inc., with 4220 participants planned, started 2024-09-27 and due to reach its primary completion in 2029-08. Interventions recorded: Elacestrant, Anastrozole, Letrozole, Exemestane and Tamoxifen.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06492616","url":"https://clinicaltrials.gov/study/NCT06492616"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["elacestrant","exemestane","tamoxifen"],"companies":["menarini"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06492616","phase":"3","setting":"Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study","sponsor":"Stemline Therapeutics, Inc.","started":"2024-09-27","startedType":"actual","enrolled":4220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06499285","kind":"trial","name":"A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular B","aka":["RENEW"],"tldr":"A phase 3 trial of Elritercept run by Takeda, now recruiting.","summary":"A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions is a phase 3 interventional study registered as NCT06499285 by Takeda, with 225 participants planned, started 2025-05-06. Conditions listed: Myelodysplastic Syndromes. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06499285","url":"https://clinicaltrials.gov/study/NCT06499285"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mds","mds-lower-risk"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["elritercept"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06499285","phase":"3","setting":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants With Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)","sponsor":"Takeda","started":"2025-05-06","startedType":"actual","enrolled":225,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07271667","kind":"trial","name":"A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies","aka":[],"tldr":"A phase 2 trial of Zanubrutinib in chronic lymphocytic leukaemia, run by Curis, Inc., now recruiting.","summary":"A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies is a phase 2 interventional study registered as NCT07271667 by Curis, Inc., with 108 participants planned, started 2026-04-23 and due to reach its primary completion in 2027-11. Interventions recorded: Emavusertib and Zanubrutinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07271667","url":"https://clinicaltrials.gov/study/NCT07271667"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll"],"sections":[],"technologies":[],"targets":[],"drugs":["zanubrutinib","emavusertib"],"companies":["curis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07271667","phase":"2","setting":"A Phase 2 Study of Emavusertib in Combination With an Approved Bruton Tyrosine Kinase Inhibitor in Patients With Chronic Lymphocytic Leukemia and Other B-cell Malignancies","sponsor":"Curis, Inc.","started":"2026-04-23","startedType":"actual","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05377996","kind":"trial","name":"A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Emi-Le in triple-negative breast cancer, endometrial cancer, ovarian cancer and salivary gland cancers, run by Day One Biopharmaceuticals, Inc., now recruiting.","summary":"A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors is a phase 1/2 interventional study registered as NCT05377996 by Day One Biopharmaceuticals, Inc., with 360 participants planned, started 2022-08-15 and due to reach its primary completion in 2027-02. Interventions recorded: Emi-Le.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05377996","url":"https://clinicaltrials.gov/study/NCT05377996"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","endometrial","ovarian","salivary-gland","mucoepidermoid-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["day-one-biopharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05377996","phase":"1/2","setting":"A Phase 1/2, First-in-human, Multicenter Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors","sponsor":"Day One Biopharmaceuticals, Inc.","started":"2022-08-15","startedType":"actual","enrolled":360,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05217446","kind":"trial","name":"A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic","aka":["SEAMARK"],"tldr":"A phase 2 trial of Encorafenib, Cetuximab, Pembrolizumab in colorectal cancer, run by Pfizer, active and no longer recruiting.","summary":"A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer is a phase 2 interventional study registered as NCT05217446 by Pfizer, with 108 participants enrolled, started 2022-07-11 and due to reach its primary completion in 2026-06-19. Interventions recorded: Encorafenib, Cetuximab, Pembrolizumab. Conditions listed: Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05217446","url":"https://clinicaltrials.gov/study/NCT05217446"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","braf-v600e-colorectal","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["encorafenib","cetuximab","pembrolizumab"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05217446","phase":"2","setting":"A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI H/DMMR METASTATIC COLORECTAL CANCER","sponsor":"Pfizer","started":"2022-07-11","startedType":"actual","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06099769","kind":"trial","name":"A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer","aka":[],"tldr":"A phase 2 trial of Enzalutamide and Mifepristone in Breast cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer is a phase 2 interventional study registered as NCT06099769 by Memorial Sloan Kettering Cancer Center, with 201 participants planned, started 2023-10-18 and due to reach its primary completion in 2027-10. Interventions recorded: Enzalutamide, Mifepristone, TPC. Conditions recorded: Metastatic Breast Cancer.\n\nLinked to the drug Mifepristone because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06099769","url":"https://clinicaltrials.gov/study/NCT06099769"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["enzalutamide","mifepristone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06099769","phase":"2","setting":"A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW BREAST CANCER","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2023-10-18","startedType":"actual","enrolled":201,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05443126","kind":"trial","name":"A Study of EP0031 (Lunbotinib) in Patients With Advanced RET-altered Malignancies","aka":[],"tldr":"A phase 1/2 trial of EP0031 and Pemetrexed in non-small-cell lung cancer, run by Ellipses Pharma, now recruiting.","summary":"A Study of EP0031 (Lunbotinib) in Patients With Advanced RET-altered Malignancies is a phase 1/2 interventional study registered as NCT05443126 by Ellipses Pharma, with 265 participants planned, started 2022-09-30 and due to reach its primary completion in 2027-03. Interventions recorded: EP0031, Platinum chemotherapy and Pemetrexed.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05443126","url":"https://clinicaltrials.gov/study/NCT05443126"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","ret-fusion-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ep0031","pemetrexed"],"companies":["ellipses-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05443126","phase":"1/2","setting":"A Modular, Open-label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0031 in Patients With Advanced RET-altered Malignancies","sponsor":"Ellipses Pharma","started":"2022-09-30","startedType":"actual","enrolled":265,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03473743","kind":"trial","name":"A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer","aka":[],"tldr":"A phase 1/2 trial of Erdafitinib, Cetrelimab, Cisplatin and Carboplatin in bladder & urothelial cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer is a phase 1/2 interventional study registered as NCT03473743 by Janssen Research & Development, LLC, with 125 participants enrolled, started 2018-04-05 and due to reach its primary completion in 2022-09-30. Interventions recorded: Erdafitinib, Cetrelimab, Cisplatin and Carboplatin. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03473743","url":"https://clinicaltrials.gov/study/NCT03473743"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["erdafitinib","cetrelimab","cisplatin","carboplatin"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03473743","phase":"1/2","setting":"A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer","sponsor":"Janssen Research & Development, LLC","started":"2018-04-05","startedType":"actual","yearReported":2023,"enrolled":125,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment","primary":true,"unit":"%","arms":[{"name":"Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy","n":43,"value":44.2,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-10-25), not from a publication"},{"name":"Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg","n":44,"value":54.5}],"source":"https://clinicaltrials.gov/study/NCT03473743?tab=results"}]},{"id":"nct06623136","kind":"trial","name":"A Study of ES102 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Toripalimab in non-small-cell lung cancer and small-cell lung cancer, run by Elpiscience (Suzhou) Biopharma, Ltd., now recruiting.","summary":"A Study of ES102 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT06623136 by Elpiscience (Suzhou) Biopharma, Ltd., with 40 participants planned, started 2025-04-30 and due to reach its primary completion in 2027-02-28. Interventions recorded: ES102, Toripalimab. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06623136","url":"https://clinicaltrials.gov/study/NCT06623136"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":["elpiscience-suzhou-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06623136","phase":"2","setting":"An Open-label, Multicenter, Single-arm Phase 2 Study of ES102 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer","sponsor":"Elpiscience (Suzhou) Biopharma, Ltd.","started":"2025-04-30","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03980054","kind":"trial","name":"A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer","aka":[],"tldr":"A phase 3 trial of Pyrotinib in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., active and no longer recruiting.","summary":"A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer is a phase 3 interventional study registered as NCT03980054 by Jiangsu HengRui Medicine Co., Ltd., with 2135 participants enrolled, started 2019-07-12 and due to reach its primary completion in 2027-06. Interventions recorded: Pyrotinib and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03980054","url":"https://clinicaltrials.gov/study/NCT03980054"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["pyrotinib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03980054","phase":"3","setting":"A Phase III Study to Evaluate the Efficacy and Safety of Pyrotinib Versus Placebo in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2019-07-12","startedType":"actual","enrolled":2135,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06782555","kind":"trial","name":"A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab","aka":[],"tldr":"A phase 1/2 trial of Zalifrelimab and Balstilimab in prostate cancer, head and neck squamous cell carcinoma and pancreatic ductal adenocarcinoma, run by ImmunoGenesis, now recruiting.","summary":"A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab is a phase 1/2 interventional study registered as NCT06782555 by ImmunoGenesis, with 71 participants planned, started 2025-01-08 and due to reach its primary completion in 2027-10. Interventions recorded: Evofosfamide, Zalifrelimab and Balstilimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06782555","url":"https://clinicaltrials.gov/study/NCT06782555"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","head-and-neck","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["zalifrelimab","balstilimab","evofosfamide"],"companies":["agenus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06782555","phase":"1/2","setting":"A Phase 1/2 Immunotherapy Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab in Patients with Advanced Solid Malignancies","sponsor":"ImmunoGenesis","started":"2025-01-08","startedType":"actual","enrolled":71,"enrolledBasis":"registry","outcomes":[]},{"id":"aspen-06","kind":"trial","name":"A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)","aka":["ASPEN-06"],"tldr":"A phase 2/3 trial testing Evorpacept in gastric & gastro-oesophageal junction cancer, active and no longer recruiting.","summary":"A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06) is a phase 2/3 interventional study registered as NCT05002127, led by ALX Oncology with Eli Lilly and, and active but no longer recruiting on the registry. Official title: A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06). Planned enrolment is 127 participants (actual). The study started in 2022-01-15 and primary completion is expected in 2024-05-24. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05002127","url":"https://clinicaltrials.gov/study/NCT05002127"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":["cd47-blockade"],"targets":[],"drugs":["evorpacept"],"companies":["alx-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05002127","phase":"2/3","setting":"A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)","sponsor":"ALX Oncology","started":"2022-01-15","startedType":"actual","enrolled":127,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07312188","kind":"trial","name":"A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 2 trial of F182112, Pomalidomide in multiple myeloma, run by Shandong New Time Pharmaceutical Co., LTD, now recruiting.","summary":"A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT07312188 by Shandong New Time Pharmaceutical Co., LTD, with 90 participants planned, started 2025-07-02 and due to reach its primary completion in 2028-05-20. Interventions recorded: F182112+P, F182112+CD38. Conditions listed: Relapsed or Refractory Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07312188","url":"https://clinicaltrials.gov/study/NCT07312188"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["f182112","pomalidomide"],"companies":["shandong-new-time-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07312188","phase":"2","setting":"A Phase II Study of F182112 Combined With Different Administration Regimens in Patients With Relapsed or Refractory Multiple Myeloma","sponsor":"Shandong New Time Pharmaceutical Co., LTD","started":"2025-07-02","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06499350","kind":"trial","name":"A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Tislelizumab in advanced solid tumours, run by FindCure Biosciences (ZhongShan) Co., Ltd., now recruiting.","summary":"A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors is a phase 1/2 interventional study registered as NCT06499350 by FindCure Biosciences (ZhongShan) Co., Ltd., with 33 participants planned, started 2024-11-13 and due to reach its primary completion in 2026-12-01. Interventions recorded: FC084CSA+Tislelizumab combination (dose escalation) and RP2D of FC084CSA+Tislelizumab combination (dose expansion).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06499350","url":"https://clinicaltrials.gov/study/NCT06499350"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06499350","phase":"1/2","setting":"A Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of AXL Inhibitor FC084CSA Tablets in Combination With Tislelizumab in the Treatment of Advanced Malignant Solid Tumors","sponsor":"FindCure Biosciences (ZhongShan) Co., Ltd.","started":"2024-11-13","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06842498","kind":"trial","name":"A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","aka":[],"tldr":"A phase 2 trial of FG-3246 in prostate cancer, run by Kyntra Bio, now recruiting.","summary":"A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) is a phase 2 interventional study registered as NCT06842498 by Kyntra Bio, with 75 participants planned, started 2026-02-22 and due to reach its primary completion in 2028-03-31. Interventions recorded: FG-3246.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06842498","url":"https://clinicaltrials.gov/study/NCT06842498"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["adc"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06842498","phase":"2","setting":"A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) in Patients With Metastatic Castration-Resistant Prostate Cancer","sponsor":"Kyntra Bio","started":"2026-02-22","startedType":"actual","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07383922","kind":"trial","name":"A Study of FG-M108+Chemotherapy vs Placebo+Chemotherapy in Claudin18.2-positive Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial of nab-paclitaxel and gemcitabine in pancreatic cancer, run by FutureGen Biopharmaceutical (Beijing) Co., Ltd, not yet recruiting.","summary":"A Study of FG-M108+Chemotherapy vs Placebo+Chemotherapy in Claudin18.2-positive Pancreatic Cancer is a phase 3, randomised interventional study registered as NCT07383922 by FutureGen Biopharmaceutical (Beijing) Co., Ltd, with a registry enrolment figure of 524 participants, started 2026-02-28 and due to reach its primary completion in 2030-06-30. Interventions recorded: FG-M108; nab paclitaxel; Gemcitabine (GEM); Placebo for FG-M108. Conditions listed: Pancreatic Cancer. Primary outcome: Overall Survival (OS). Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, without prior systemic therapy; or for subjects who have received prior neoadjuvant/adjuvant chemotherapy, the time from the last treatment to disease recurrence is \\>6 months;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07383922","url":"https://clinicaltrials.gov/study/NCT07383922"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["nab-paclitaxel","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07383922","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled Phase 3 Study Comparing the Efficacy and Safety of FG-M108 Versus Placebo Combined With Standard Chemotherapy in First-line Treatment of Patients With Claudin18.2-Positive Advanced Pancreatic Cancer","sponsor":"FutureGen Biopharmaceutical (Beijing) Co., Ltd","started":"2026-02-28","startedType":"estimated","enrolled":524,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06064877","kind":"trial","name":"A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma","aka":["FIERCE-HN"],"tldr":"A phase 3 trial testing Ficlatuzumab in head and neck squamous cell carcinoma, now recruiting.","summary":"A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma is a phase 3 interventional study registered as NCT06064877, led by AVEO Pharmaceuticals, and recruiting on the registry. Official title: A Multicenter, Randomised, Double Blind, Placebo - Controlled, Phase 3 Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV -Negative Head and Neck Squamous Cell Carcinoma. (FIERCE-HN). Planned enrolment is 410 participants (estimated). The study started in 2024-01-11 and primary completion is expected in 2027-08. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06064877","url":"https://clinicaltrials.gov/study/NCT06064877"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","hpv-negative-head-and-neck-cancer","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["ficlatuzumab"],"companies":["aveo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06064877","phase":"3","setting":"A Multicenter, Randomized, Double Blind, Placebo - Controlled, Phase 3 Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV -Negative Head and Neck Squamous Cell Carcinoma. (FIERCE-HN)","sponsor":"AVEO Pharmaceuticals","started":"2024-01-11","startedType":"actual","enrolled":410,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06119581","kind":"trial","name":"A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer","aka":["SUNRAY-01"],"tldr":"A phase 3 trial of Olomorasib, Pembrolizumab, Cisplatin, Carboplatin and Pemetrexed in non-small-cell lung cancer, run by Eli Lilly and Company, now recruiting.","summary":"A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT06119581 by Eli Lilly and Company, with 1264 participants planned, started 2023-12-21 and due to reach its primary completion in 2027-11. Interventions recorded: LY3537982, Pembrolizumab, Placebo, Cisplatin, Carboplatin and Pemetrexed.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06119581","url":"https://clinicaltrials.gov/study/NCT06119581"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","kras-inhibitors"],"targets":[],"drugs":["olomorasib","pembrolizumab","cisplatin","carboplatin","pemetrexed"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06119581","phase":"3","setting":"SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression","sponsor":"Eli Lilly and Company","started":"2023-12-21","startedType":"actual","enrolled":1264,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07131202","kind":"trial","name":"A Study of FL115 in Combination With a PD-1 Antibody in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of FL115+PD-1 in advanced solid tumours, run by Suzhou Forlong Biotechnology Co., Ltd, now recruiting.","summary":"A Study of FL115 in Combination With a PD-1 Antibody in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07131202 by Suzhou Forlong Biotechnology Co., Ltd, with 130 participants planned, started 2026-01-08 and due to reach its primary completion in 2026-12-05. Interventions recorded: FL115+PD-1.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07131202","url":"https://clinicaltrials.gov/study/NCT07131202"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["suzhou-forlong-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07131202","phase":"1/2","setting":"A Phase Ib/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Pharmacodynamics of FL115 in Combination With a PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors","sponsor":"Suzhou Forlong Biotechnology Co., Ltd","started":"2026-01-08","startedType":"estimated","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07011576","kind":"trial","name":"A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)","aka":["FRUITFUL"],"tldr":"A phase 2 trial of fruquintinib and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by SCRI Development Innovations, LLC, now recruiting.","summary":"A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL) is a phase 2, interventional study registered as NCT07011576 by SCRI Development Innovations, LLC, with a registry enrolment figure of 60 participants, started 2025-09-29 and due to reach its primary completion in 2027-01. Interventions recorded: fruquintinib; FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin). Conditions listed: Colon Cancer; Rectal Cancer; Colorectal Cancer; Colorectal Cancer (CRC). Primary outcome: Progression-Free Survival (PFS) rate at 6 months. Colorectal eligibility wording from the registry: \"* Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07011576","url":"https://clinicaltrials.gov/study/NCT07011576"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","kinase-inhibitors","topoisomerase-inhibitors"],"targets":[],"drugs":["fruquintinib","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07011576","phase":"2","setting":"A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)","sponsor":"SCRI Development Innovations, LLC","started":"2025-09-29","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06980480","kind":"trial","name":"A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma","aka":[],"tldr":"A phase 3 trial of IGI, 10% in multiple myeloma, run by Takeda, now recruiting.","summary":"A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma is a phase 3 interventional study registered as NCT06980480 by Takeda, with 183 participants planned, started 2026-01-14 and due to reach its primary completion in 2028-09-11. Interventions recorded: IGI, 10%.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06980480","url":"https://clinicaltrials.gov/study/NCT06980480"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06980480","phase":"3","setting":"A Multicenter, Randomized, Controlled, Open-label, Group-Sequential, Phase 3 Study to Investigate the Efficacy, Safety, and Tolerability of Intravenous Gammagard Liquid (Immune Globulin Infusion, 10%) for Primary Infection Prophylaxis Compared With Secondary Infection Prophylaxis in Adult Subjects With Multiple Myeloma Receiving B-Cell Maturation AntigenxCD3-Directed Bispecific Antibody Therapy","sponsor":"Takeda","started":"2026-01-14","startedType":"actual","enrolled":183,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05851014","kind":"trial","name":"A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer","aka":[],"tldr":"A phase 3 trial of Lerociclib run by Genor Biopharma Co., Ltd., now recruiting.","summary":"A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer is a phase 3 interventional study registered as NCT05851014 by Genor Biopharma Co., Ltd., with 350 participants planned, started 2022-01-14. Conditions listed: Breast Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05851014","url":"https://clinicaltrials.gov/study/NCT05851014"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["lerociclib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05851014","phase":"3","setting":"A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of GB491 in Combination With Letrozole in Subjects With HR Positive and HER2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received Systemic Therapy in This Disease Setting","sponsor":"Genor Biopharma Co., Ltd.","started":"2022-01-14","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06235229","kind":"trial","name":"A Study of GC012F in Patients With Relapsed/Refractory Multiple Myeloma","aka":["DURGA-3"],"tldr":"A phase 1/2 trial of GC012F in multiple myeloma, run by Gracell Biotechnologies (Shanghai) Co., Ltd., now recruiting.","summary":"A Study of GC012F in Patients With Relapsed/Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT06235229 by Gracell Biotechnologies (Shanghai) Co., Ltd., with 110 participants planned, started 2023-12-26 and due to reach its primary completion in 2026-03-02. Interventions recorded: GC012F. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06235229","url":"https://clinicaltrials.gov/study/NCT06235229"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["gc012f"],"companies":["gracell-biotechnologies"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06235229","phase":"1/2","setting":"A Phase I/II Clinical Study of Chimeric Antigen Receptor T-cell Therapy Targeting CD19 and BCMA (GC012F) in Patients With Relapsed/Refractory Multiple Myeloma","sponsor":"Gracell Biotechnologies (Shanghai) Co., Ltd.","started":"2023-12-26","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06703398","kind":"trial","name":"A Study of GC101 TIL in Advanced Melanoma","aka":["MIZAR-003"],"tldr":"A phase 2 trial of GC101 TIL, Dacarbazine, Temozolomide in melanoma, run by Shanghai Juncell Therapeutics, now recruiting.","summary":"A Study of GC101 TIL in Advanced Melanoma is a phase 2 interventional study registered as NCT06703398 by Shanghai Juncell Therapeutics, with 98 participants planned, started 2024-12-20 and due to reach its primary completion in 2026-05-12. Interventions recorded: GC101 TIL, dacarbazine, temozolomide, paclitaxel ,platinum or cisplatin. Conditions listed: Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06703398","url":"https://clinicaltrials.gov/study/NCT06703398"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["gc101-til","dacarbazine","temozolomide","paclitaxel"],"companies":["shanghai-juncell-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06703398","phase":"2","setting":"A Multicenter, Randomized, Controlled,Open Label, Phase II Trial of Autologous Tumor Infiltrating Lymphocytes (GC101 TIL) in Subjects With Advanced Melanoma","sponsor":"Shanghai Juncell Therapeutics","started":"2024-12-20","startedType":"actual","enrolled":98,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06375733","kind":"trial","name":"A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL","aka":[],"tldr":"A phase 1/2 trial of Zanubrutinib in diffuse large B-cell lymphoma, run by Genfleet Therapeutics (Shanghai) Inc., now recruiting.","summary":"A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL is a phase 1/2 interventional study registered as NCT06375733 by Genfleet Therapeutics (Shanghai) Inc., with 51 participants planned, started 2024-03-20 and due to reach its primary completion in 2026-12-31. Interventions recorded: GFH009 and Zanubrutinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06375733","url":"https://clinicaltrials.gov/study/NCT06375733"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["zanubrutinib"],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06375733","phase":"1/2","setting":"A Phase Ib/II, Multicenter, Open-label, Single-arm Study to Assess the Safety and Efficacy of GFH009 in Combination With Zanubrutinib in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)","sponsor":"Genfleet Therapeutics (Shanghai) Inc.","started":"2024-03-20","startedType":"actual","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05934513","kind":"trial","name":"A Study of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)","aka":[],"tldr":"A phase 1/2 trial of GFH009 in peripheral T-cell lymphomas, run by Genfleet Therapeutics (Shanghai) Inc., now recruiting.","summary":"A Study of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) is a phase 1/2 interventional study registered as NCT05934513 by Genfleet Therapeutics (Shanghai) Inc., with 95 participants planned, started 2023-09-06 and due to reach its primary completion in 2025-12-30. Interventions recorded: GFH009.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05934513","url":"https://clinicaltrials.gov/study/NCT05934513"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05934513","phase":"1/2","setting":"A Phase Ib/II, Multicentre, Open-label Study to Assess the Efficacy, Safety/ Tolerability and Pharmacokinetic of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)","sponsor":"Genfleet Therapeutics (Shanghai) Inc.","started":"2023-09-06","startedType":"actual","enrolled":95,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07678593","kind":"trial","name":"A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation","aka":[],"tldr":"A phase 1/2 trial of cetuximab, nab-paclitaxel, gemcitabine, fluorouracil (5-FU) and other drugs in pancreatic cancer, run by Genfleet Therapeutics (Shanghai) Inc., not yet recruiting.","summary":"A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation is a phase 1/2, interventional study registered as NCT07678593 by Genfleet Therapeutics (Shanghai) Inc., with a registry enrolment figure of 222 participants, started 2026-09 and due to reach its primary completion in 2027-11. Interventions recorded: GFH276; Cetuximab; Nab paclitaxel; Gemcitabine; Fluorouracil; Leucovorin; Irinotecan; Oxaliplatin. Conditions listed: Advanced Solid Tumors Cancer; Pancreatic Ductal Adenocarcinoma; RAS Mutation. Primary outcome: Phase Ib:Incidence of Dose-Limiting Toxicity (DLT) Events; Phase Ib:Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE); Phase II:Objective Response Rate (ORR). Sites: Australia, China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07678593","url":"https://clinicaltrials.gov/study/NCT07678593"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cetuximab","nab-paclitaxel","gemcitabine","fluorouracil","flot","folfiri","capox"],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07678593","phase":"1/2","setting":"A Multi-center, Open-label Phase Ib/II Study Exploring the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH276 in Combination With Cetuximab or Chemotherapy in the Treatment of Patients With Advanced Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation","sponsor":"Genfleet Therapeutics (Shanghai) Inc.","started":"2026-09","startedType":"estimated","enrolled":222,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07259590","kind":"trial","name":"A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation","aka":[],"tldr":"A phase 1/2 trial of GFH375, Cetuximab, Paclitaxel / nab-paclitaxel in colorectal cancer, run by Genfleet Therapeutics (Shanghai) Inc., now recruiting.","summary":"A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation is a phase 1/2 interventional study registered as NCT07259590 by Genfleet Therapeutics (Shanghai) Inc., with 126 participants planned, started 2025-10-21 and due to reach its primary completion in 2027-07. Interventions recorded: GFH375, GFH375. Conditions listed: Advanced Solid Tumors Cancer, PDAC, CRC (Colorectal Cancer). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07259590","url":"https://clinicaltrials.gov/study/NCT07259590"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","kras-g12c-colorectal"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["gfh375","cetuximab","paclitaxel","gemcitabine"],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07259590","phase":"1/2","setting":"A Multicenter, Open-Label, Phase Ib/II Clinical Study to Explore the Efficacy, Pharmacokinetics and Safety/Tolerability of GFH375 in Combination With Cetuximab or Chemotherapy in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutation","sponsor":"Genfleet Therapeutics (Shanghai) Inc.","started":"2025-10-21","startedType":"actual","enrolled":126,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06500676","kind":"trial","name":"A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations","aka":[],"tldr":"A phase 1/2 trial of GFH375 in advanced solid tumours, run by Genfleet Therapeutics (Shanghai) Inc., now recruiting.","summary":"A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations is a phase 1/2 interventional study registered as NCT06500676 by Genfleet Therapeutics (Shanghai) Inc., with 407 participants planned, started 2024-07-09 and due to reach its primary completion in 2028-07-31. Interventions recorded: GFH375.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06500676","url":"https://clinicaltrials.gov/study/NCT06500676"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["gfh375"],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06500676","phase":"1/2","setting":"An Open-Label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GFH375 in Patients With KRAS G12D Mutant Advanced Solid Tumors","sponsor":"Genfleet Therapeutics (Shanghai) Inc.","started":"2024-07-09","startedType":"actual","enrolled":407,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07172802","kind":"trial","name":"A Study of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as Monotherapy in Patients With Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of GI-108 in non-small-cell lung cancer, head and neck squamous cell carcinoma, pancreatic ductal adenocarcinoma and renal cell carcinoma, run by GI Innovation, Inc., now recruiting.","summary":"A Study of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as Monotherapy in Patients With Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT07172802 by GI Innovation, Inc., with 76 participants planned, started 2025-04-22 and due to reach its primary completion in 2027-02. Interventions recorded: GI-108.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07172802","url":"https://clinicaltrials.gov/study/NCT07172802"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","head-and-neck","pancreatic","rcc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["gi-innovation"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07172802","phase":"1/2","setting":"An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as a Single Agent in Patients With Advanced or Metastatic Solid Tumors","sponsor":"GI Innovation, Inc.","started":"2025-04-22","startedType":"actual","enrolled":76,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05520567","kind":"trial","name":"A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia","aka":[],"tldr":"A phase 1/2 trial of Gilteritinib, Venetoclax and Azacitidine in acute myeloid leukaemia, run by Astellas Pharma Global Development, Inc., active and no longer recruiting.","summary":"A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia is a phase 1/2 interventional study registered as NCT05520567 by Astellas Pharma Global Development, Inc., with 70 participants enrolled, started 2023-01-31 and due to reach its primary completion in 2028-07-31. Interventions recorded: Gilteritinib, Venetoclax and Azacitidine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05520567","url":"https://clinicaltrials.gov/study/NCT05520567"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-older-unfit"],"sections":[],"technologies":["bcl2-inhibitors","cytotoxic-chemotherapy","epigenetic-drugs","kinase-inhibitors"],"targets":[],"drugs":["gilteritinib","venetoclax","azacitidine"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05520567","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open-Label, Randomized Dose Ranging and Expansion Study of the Combination of Gilteritinib, Venetoclax and Azacitidine in Patients With Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia (AML) Not Eligible for Intensive Induction Chemotherapy","sponsor":"Astellas Pharma Global Development, Inc.","started":"2023-01-31","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05798819","kind":"trial","name":"A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervic","aka":[],"tldr":"A phase 3 trial of Zimberelimab run by Guangzhou Gloria Biosciences Co., Ltd. in cervical cancer, now recruiting.","summary":"A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer is a phase 3 interventional study registered as NCT05798819 by Guangzhou Gloria Biosciences Co., Ltd., with 424 participants planned, started 2023-04-20. Conditions listed: Persistent, Recurrent, or Metastatic Cervical Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05798819","url":"https://clinicaltrials.gov/study/NCT05798819"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["zimberelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05798819","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate GLS-010 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer","sponsor":"Guangzhou Gloria Biosciences Co., Ltd.","started":"2023-04-20","startedType":"actual","enrolled":424,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05944978","kind":"trial","name":"A Study of GNC-035 in Relapsed or Refractory Chronic Lymphocytic Leukemia and Other Hematological Malignancies","aka":[],"tldr":"A phase 1/2 trial of GNC-035 in chronic lymphocytic leukaemia, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of GNC-035 in Relapsed or Refractory Chronic Lymphocytic Leukemia and Other Hematological Malignancies is a phase 1/2 interventional study registered as NCT05944978 by Sichuan Baili Pharmaceutical Co., Ltd., with 3 participants enrolled, started 2023-08-16 and due to reach its primary completion in 2025-12. Interventions recorded: GNC-035.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05944978","url":"https://clinicaltrials.gov/study/NCT05944978"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05944978","phase":"1/2","setting":"Phase Ib/II Clinical Study of GNC-035 Tetra-specific Antibody Injection in Relapsed or Refractory Chronic Lymphocytic Leukemia and Other Hematological Malignancies","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-08-16","startedType":"actual","enrolled":3,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06066203","kind":"trial","name":"A Study of GNC-035 in Relapsed or Refractory Non-Hodgkin 's Lymphoma and Other Hematological Malignancies","aka":[],"tldr":"A phase 1/2 trial of GNC-035 in non-Hodgkin lymphoma, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of GNC-035 in Relapsed or Refractory Non-Hodgkin 's Lymphoma and Other Hematological Malignancies is a phase 1/2 interventional study registered as NCT06066203 by Sichuan Baili Pharmaceutical Co., Ltd., with 40 participants planned, started 2023-11-01 and due to reach its primary completion in 2026-12. Interventions recorded: GNC-035.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06066203","url":"https://clinicaltrials.gov/study/NCT06066203"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06066203","phase":"1/2","setting":"An Open, Multicenter, Phase I / II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics / Pharmacodynamics and Antitumor Activity of GNC-035 Tetra-specific Antibody Injection in Relapsed or Refractory Non-Hodgkin 's Lymphoma and Other Hematological Malignancies","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-11-01","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05627856","kind":"trial","name":"A Study of GNC-038 Injection in Patients With Relapsed or Refractory NK/ T-cell Lymphoma, AITL, and Other NHL","aka":[],"tldr":"A phase 1/2 trial of GNC-038 in peripheral T-cell lymphomas and non-Hodgkin lymphoma, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of GNC-038 Injection in Patients With Relapsed or Refractory NK/ T-cell Lymphoma, AITL, and Other NHL is a phase 1/2 interventional study registered as NCT05627856 by Sichuan Baili Pharmaceutical Co., Ltd., with 4 participants enrolled, started 2023-02-21 and due to reach its primary completion in 2025-12. Interventions recorded: GNC-038.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05627856","url":"https://clinicaltrials.gov/study/NCT05627856"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05627856","phase":"1/2","setting":"An Open, Multicenter, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacokinetics, and Antitumor Activity of GNC-038 Injection in Relapsed or Refractory NK/ T-cell Lymphoma, AITL, and Other NHL","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-02-21","startedType":"actual","enrolled":4,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05623982","kind":"trial","name":"A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma","aka":[],"tldr":"A phase 1/2 trial of GNC-038 in non-Hodgkin lymphoma, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma is a phase 1/2 interventional study registered as NCT05623982 by Sichuan Baili Pharmaceutical Co., Ltd., with 40 participants planned, started 2022-09-26 and due to reach its primary completion in 2026-12. Interventions recorded: GNC-038.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05623982","url":"https://clinicaltrials.gov/study/NCT05623982"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05623982","phase":"1/2","setting":"An Open, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Tetra-specific Antibody GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2022-09-26","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05192486","kind":"trial","name":"A Study of GNC-038, a Tetra-specific Antibody, in Participants With R/R Diffuse Large B-cell Lymphoma (DLBCL)","aka":[],"tldr":"A phase 1/2 trial of GNC-038 in diffuse large B-cell lymphoma, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of GNC-038, a Tetra-specific Antibody, in Participants With R/R Diffuse Large B-cell Lymphoma (DLBCL) is a phase 1/2 interventional study registered as NCT05192486 by Sichuan Baili Pharmaceutical Co., Ltd., with 12 participants enrolled, started 2022-08-10 and due to reach its primary completion in 2025-12. Interventions recorded: GNC-038.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05192486","url":"https://clinicaltrials.gov/study/NCT05192486"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05192486","phase":"1/2","setting":"An Open-Label, Multi-Center, Phase Ib/II Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Tetra-specific Antibody GNC-038 in Participants With Recurrent or Refractory Diffuse Large B-cell Lymphoma (DLBCL)","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2022-08-10","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07101679","kind":"trial","name":"A Study of GnP RegimenCombined With Serplulimab and Stereotactic Body Radiation Therapy as First-line Treatment for Locally Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by West China Hospital, now recruiting.","summary":"A Study of GnP RegimenCombined With Serplulimab and Stereotactic Body Radiation Therapy as First-line Treatment for Locally Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT07101679 by West China Hospital, with a registry enrolment figure of 23 participants, started 2025-04-16 and due to reach its primary completion in 2027-04-15. Interventions recorded: LICSBR. Conditions listed: Locally Advanced Pancreatic Ductal Adenocarcinoma. Primary outcome: Investigator-assessed Objective Response Rate (ORR). Pancreatic eligibility wording from the registry: \"Inclusion Criteria (1)Histologically confirmed pancreatic ductal adenocarcinoma with diagnosis based on comprehensive assessment of pathology and imaging studies (CT or MRI), supplemented by fibroblast activation protein positron emission tomography-computed tomography (FAPI PET-CT) when necessary, \". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07101679","url":"https://clinicaltrials.gov/study/NCT07101679"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07101679","phase":"2","setting":"A Phase II Clinical Study of GnP Regimen (Nab-paclitaxel + Gemcitabine) Combined With Serplulimab and Stereotactic Body Radiation Therapy (SBRT) as First-line Treatment for Locally Advanced Pancreatic Cancer","sponsor":"West China Hospital","started":"2025-04-16","startedType":"actual","enrolled":23,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06464055","kind":"trial","name":"A Study of GQ1010 in Subjects With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Dose Escalation in advanced solid tumours, run by GeneQuantum Healthcare (Suzhou) Co., Ltd., now recruiting.","summary":"A Study of GQ1010 in Subjects With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06464055 by GeneQuantum Healthcare (Suzhou) Co., Ltd., with 260 participants planned, started 2024-05-23 and due to reach its primary completion in 2028-05-23. Interventions recorded: Dose Escalation, Dose Expansion1, Dose Expansion2, Dose Expansion3 and phase II.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06464055","url":"https://clinicaltrials.gov/study/NCT06464055"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":[],"companies":["genequantum-healthcare-suzhou"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06464055","phase":"1/2","setting":"A Phase I/II, Multicenter, Open-Label, Dose-Escalation and Extension Study of GQ1010(an Anti-Trop2 ADC) in Subjects With Advanced Solid Tumors","sponsor":"GeneQuantum Healthcare (Suzhou) Co., Ltd.","started":"2024-05-23","startedType":"actual","enrolled":260,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07192588","kind":"trial","name":"A Study of GR1014 Cutaneous Gel for the Prevention of Skin Reactions Caused by Radiation Therapy for Breast Cancer","aka":["GuARD"],"tldr":"A phase 2 trial of GR1014-CG 2.4% in advanced solid tumours, run by Graegis Pharmaceuticals Ltd, active and no longer recruiting.","summary":"A Study of GR1014 Cutaneous Gel for the Prevention of Skin Reactions Caused by Radiation Therapy for Breast Cancer is a phase 2 interventional study registered as NCT07192588 by Graegis Pharmaceuticals Ltd, with 273 participants enrolled, started 2024-07-26 and due to reach its primary completion in 2026-09-30. Interventions recorded: GR1014-CG 2.4%, Vehicle Gel, Radiation Therapy and GR1014-CG 4.7%.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07192588","url":"https://clinicaltrials.gov/study/NCT07192588"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07192588","phase":"2","setting":"A Randomised, Double-Blind, Vehicle-Controlled, Multi-Centre, Parallel-Group Study to Investigate the Safety, Tolerability, and Efficacy of GR1014 Cutaneous Gel as a Topical Radioprotector in the Prevention of the Radiodermatitis Occurring With Adjuvant Radiotherapy for Localised Breast Cancer After Lumpectomy","sponsor":"Graegis Pharmaceuticals Ltd","started":"2024-07-26","startedType":"actual","enrolled":273,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07452198","kind":"trial","name":"A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 3 trial testing GR1803 in multiple myeloma, now recruiting.","summary":"A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT07452198, led by Genrix (Shanghai) Biopharmaceutical, and recruiting on the registry. Official title: A Phase 3, Multicenter, Open-Label, Randomised Study Comparing GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy Including Lenalidomide and Proteasome Inhibitors. Planned enrolment is 358 participants (estimated). The study started in 2026-03-09 and primary completion is expected in 2029-03. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07452198","url":"https://clinicaltrials.gov/study/NCT07452198"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["gr1803"],"companies":["genrix-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07452198","phase":"3","setting":"A Phase 3, Multicenter, Open-Label, Randomized Study Comparing GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy Including Lenalidomide and Proteasome Inhibitors","sponsor":"Genrix (Shanghai) Biopharmaceutical","started":"2026-03-09","startedType":"actual","enrolled":358,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06990880","kind":"trial","name":"A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer","aka":[],"tldr":"A phase 1/2 trial of GSK5458514 in prostate cancer, run by GlaxoSmithKline, now recruiting.","summary":"A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer is a phase 1/2 interventional study registered as NCT06990880 by GlaxoSmithKline, with 85 participants planned, started 2025-06-12 and due to reach its primary completion in 2027-10-26. Interventions recorded: GSK5458514.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06990880","url":"https://clinicaltrials.gov/study/NCT06990880"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06990880","phase":"1/2","setting":"A Phase 1/2 First-Time-In-Human, Open-Label, Multicenter, Dose Escalation and Expansion Study of GSK5458514 PSMA Targeting T Cell Engager Alone or in Combination With Other Anti-Cancer Agents in Adult Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","sponsor":"GlaxoSmithKline","started":"2025-06-12","startedType":"actual","enrolled":85,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07099898","kind":"trial","name":"A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)","aka":[],"tldr":"A phase 3 trial of Topotecan in small-cell lung cancer, run by GlaxoSmithKline, now recruiting.","summary":"A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) is a phase 3 interventional study registered as NCT07099898 by GlaxoSmithKline, with 420 participants planned, started 2025-08-11 and due to reach its primary completion in 2027-11-05. Interventions recorded: Ris-Rez and Topotecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07099898","url":"https://clinicaltrials.gov/study/NCT07099898"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["topotecan"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07099898","phase":"3","setting":"Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), Compared With Topotecan in Participants With Relapsed Small Cell Lung Cancer (SCLC)","sponsor":"GlaxoSmithKline","started":"2025-08-11","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05669430","kind":"trial","name":"A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in endometrial cancer, head and neck squamous cell carcinoma, melanoma and non-small-cell lung cancer, run by GV20 Therapeutics, now recruiting.","summary":"A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies is a phase 1/2 interventional study registered as NCT05669430 by GV20 Therapeutics, with 365 participants planned, started 2023-03-23 and due to reach its primary completion in 2026-12-15. Interventions recorded: GV20-0251 and GV20-0251 and Pembrolizumab [KEYTRUDA®].","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05669430","url":"https://clinicaltrials.gov/study/NCT05669430"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial","head-and-neck","melanoma","nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck","gv20-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05669430","phase":"1/2","setting":"An Open-Label Phase 1/2A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Advanced and/or Refractory Solid Tumor Malignancies","sponsor":"GV20 Therapeutics","started":"2023-03-23","startedType":"actual","enrolled":365,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07376629","kind":"trial","name":"A Study of HB0025 Plus Nab-paclitaxel as First Line Therapy for TNBC","aka":[],"tldr":"A phase 2 trial of nab-paclitaxel in triple-negative breast cancer, run by Huabo Biopharm Co., Ltd., now recruiting.","summary":"A Study of HB0025 Plus Nab-paclitaxel as First Line Therapy for TNBC is a phase 2, interventional study registered as NCT07376629 by Huabo Biopharm Co., Ltd., with a registry enrolment figure of 60 participants, started 2025-08-14 and due to reach its primary completion in 2027-01-15. Interventions recorded: HB0025 20 mg/kg plus nab-paclitaxel; HB0025 10 mg/kg plus nab-paclitaxel. Conditions listed: TNBC. Triple-negative eligibility wording from the registry: \"Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07376629","url":"https://clinicaltrials.gov/study/NCT07376629"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["nab-paclitaxel"],"companies":["huabo-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07376629","phase":"2","setting":"A Phase II Study of HB0025 in Combination With Nab-Paclitaxel as First Line Therapy for Unresectable, Locally Advanced or Metastatic Triple-negative Breast Cancer.","sponsor":"Huabo Biopharm Co., Ltd.","started":"2025-08-14","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07124936","kind":"trial","name":"A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma","aka":[],"tldr":"A phase 1/2 trial of Gemcitabine, CAPOX, Cyclophosphamide in diffuse large b-cell lymphoma, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma is a phase 1/2 interventional study registered as NCT07124936 by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., with 97 participants planned, started 2025-07-30 and due to reach its primary completion in 2027-10-26. Interventions recorded: HDM2005, Rituximab or Rituximab biosimilar, Gemcitabine, Oxaliplatin, Cyclophosphamide. Conditions listed: Diffuse Large B Cell Lymphoma (DLBCL). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07124936","url":"https://clinicaltrials.gov/study/NCT07124936"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["gemcitabine","capox","cyclophosphamide","doxorubicin","prednisone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07124936","phase":"1/2","setting":"A Phase 1b/2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma","sponsor":"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","started":"2025-07-30","startedType":"actual","enrolled":97,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07805551","kind":"trial","name":"A Study of HDM2017 Combination Therapy in Advanced Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of HDM2017, Bevacizumab, CAPOX in colorectal cancer, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of HDM2017 Combination Therapy in Advanced Colorectal Cancer is a phase 1/2 interventional study registered as NCT07805551 by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., with 220 participants planned, started 2026-08-18 and due to reach its primary completion in 2030-08. Interventions recorded: HDM2017, Bevacizumab, Oxaliplatin, Fluorouracil, Capecitabine. Conditions listed: CRC, Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07805551","url":"https://clinicaltrials.gov/study/NCT07805551"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["hdm2017","bevacizumab","capox","fluorouracil","capecitabine","flot"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07805551","phase":"1/2","setting":"A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HDM2017 Combination Therapy in Participants With Advanced Colorectal Cancer","sponsor":"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","started":"2026-08-18","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06172478","kind":"trial","name":"A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 2 trial of Patritumab deruxtecan in melanoma and cervical cancer, run by Daiichi Sankyo, now recruiting.","summary":"A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors is a phase 2 interventional study registered as NCT06172478 by Daiichi Sankyo, with 740 participants planned, started 2024-02-26 and due to reach its primary completion in 2027-09-01. Interventions recorded: HER3-DXd. Conditions listed: Advanced Solid Tumor, Melanoma, Head and Neck Cancer, Gastric Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06172478","url":"https://clinicaltrials.gov/study/NCT06172478"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","cervical","endometrial","prostate","nsclc"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["patritumab-deruxtecan"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06172478","phase":"2","setting":"HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors","sponsor":"Daiichi Sankyo","started":"2024-02-26","startedType":"actual","enrolled":740,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07678684","kind":"trial","name":"A Study of HF1K16 Combined With Bevacizumab in Patients With Recurrent or Progressive Glioma","aka":[],"tldr":"A phase 2 trial of HF1K16 in glioma & glioblastoma, run by HighField Biopharmaceuticals Corporation, now recruiting.","summary":"A Study of HF1K16 Combined With Bevacizumab in Patients With Recurrent or Progressive Glioma is a phase 2 interventional study registered as NCT07678684 by HighField Biopharmaceuticals Corporation, with 30 participants planned, started 2026-06-30 and due to reach its primary completion in 2028-12-31. Interventions recorded: HF1K16.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07678684","url":"https://clinicaltrials.gov/study/NCT07678684"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07678684","phase":"2","setting":"A Multicenter, Open-Label, Adaptive Phase Ⅱ Clinical Study of HF1K16 Combined With Bevacizumab in Recurrent or Progressive Glioma","sponsor":"HighField Biopharmaceuticals Corporation","started":"2026-06-30","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06453486","kind":"trial","name":"A Study of High Dose Radiation Therapy for Locally Advanced Pancreatic Cancer That Responded to Initial Chemotherapy Treatment","aka":["ABLATE"],"tldr":"A phase 2 trial in pancreatic cancer, run by University Health Network, Toronto, now recruiting.","summary":"A Study of High Dose Radiation Therapy for Locally Advanced Pancreatic Cancer That Responded to Initial Chemotherapy Treatment is a phase 2, interventional study registered as NCT06453486 by University Health Network, Toronto, with a registry enrolment figure of 43 participants, started 2025-03-12 and due to reach its primary completion in 2030-04. Interventions recorded: High dose radiation therapy. Conditions listed: Locally Advanced Pancreatic Adenocarcinoma. Primary outcome: Overall survival (OS). Pancreatic eligibility wording from the registry: \"* Have pancreatic tumour \\<8\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06453486","url":"https://clinicaltrials.gov/study/NCT06453486"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06453486","phase":"2","setting":"Ablative Radiation Therapy With High Dose Geometric Boost for Locally Advanced Pancreatic Cancer Patients Following Treatment Response Evaluation of Standard of Care Induction Chemotherapy (ABLATE): a Phase II Clinical Trial","sponsor":"University Health Network, Toronto","started":"2025-03-12","startedType":"actual","enrolled":43,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07140393","kind":"trial","name":"A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor","aka":[],"tldr":"A phase 1/2 trial of Capecitabine, Trastuzumab, Pertuzumab and Trastuzumab rezetecan in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor is a phase 1/2 interventional study registered as NCT07140393 by Jiangsu HengRui Medicine Co., Ltd., with 120 participants planned, started 2025-10-28 and due to reach its primary completion in 2027-10. Interventions recorded: HRS-4508+ Capecitabine, HRS-4508+ Trastuzumab, HRS-4508+ Trastuzumab+ Pertuzumab, HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel, HRS-4508+ Trastuzumab + Nab-paclitaxel and HRS-4508+ Trastuzumab+ Capecitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07140393","url":"https://clinicaltrials.gov/study/NCT07140393"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["capecitabine","trastuzumab","pertuzumab","trastuzumab-rezetecan"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07140393","phase":"1/2","setting":"An Open, Multicenter Phase IB/II Clinical Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-10-28","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06520488","kind":"trial","name":"A Study of HRS-4642 in Combination With Antineoplastic Agents in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of HRS-4642 in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Study of HRS-4642 in Combination With Antineoplastic Agents in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06520488 by Jiangsu HengRui Medicine Co., Ltd., with 118 participants planned, started 2024-08-09 and due to reach its primary completion in 2027-03. Interventions recorded: HRS-4642.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06520488","url":"https://clinicaltrials.gov/study/NCT06520488"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06520488","phase":"1/2","setting":"Phase IB/II Clinical Study of the Safety, Tolerability and Efficacy of HRS-4642 in Combination With Anti-tumor Agents in Subjects With Advanced Solid Tumors","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2024-08-09","startedType":"actual","enrolled":118,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06385678","kind":"trial","name":"A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation","aka":[],"tldr":"A phase 1/2 trial of Adebrelimab, Carboplatin, Cisplatin, Pemetrexed and Cetuximab in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., active and no longer recruiting.","summary":"A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation is a phase 1/2 interventional study registered as NCT06385678 by Jiangsu HengRui Medicine Co., Ltd., with 47 participants enrolled, started 2024-07-05 and due to reach its primary completion in 2025-12. Interventions recorded: HRS-4642, Adebrelimab, SHR-9839, Pemetrexed Disodium for Injection、Cisplatin Injection、Carboplatin for Injection and Cetuximab Solution for Infusion.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06385678","url":"https://clinicaltrials.gov/study/NCT06385678"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["adebrelimab","carboplatin","cisplatin","pemetrexed","cetuximab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06385678","phase":"1/2","setting":"A Phase IB/II Clinical Study on the Safety, Tolerability and Efficacy of HRS-4642 in Combination With Anti-tumor Medication in Subjects With Advanced Solid Tumors","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2024-07-05","startedType":"actual","enrolled":47,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06620848","kind":"trial","name":"A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in the Treatment of Advanced Biliary Tract Tumors.","aka":[],"tldr":"A phase 2 trial of adebrelimab in gallbladder cancer and other biliary tract cancers, run by Shanghai Zhongshan Hospital, now recruiting.","summary":"A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in the Treatment of Advanced Biliary Tract Tumors. is a phase 2 interventional study registered as NCT06620848 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 49 participants, started 2024-11-21 and due to reach its primary completion in 2026-12-31. Interventions recorded: HRS-4642 monotherapy, HRS-4642 and adebrelimab combination therapy. Conditions listed: Biliary Tract Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06620848","url":"https://clinicaltrials.gov/study/NCT06620848"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06620848","phase":"2","setting":"A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in Patients With Advanced Biliary Tract Tumors.","sponsor":"Shanghai Zhongshan Hospital","started":"2024-11-21","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06568094","kind":"trial","name":"A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer","aka":[],"tldr":"A phase 1/2 trial of Prednisone, Docetaxel, Darolutamide in prostate cancer, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer is a phase 1/2 interventional study registered as NCT06568094 by Jiangsu HengRui Medicine Co., Ltd., with 100 participants planned, started 2024-09-25 and due to reach its primary completion in 2026-06. Interventions recorded: HRS-5041 tablets, Abiraterone Acetate tablets（II）, Prednisone Acetate tablets, Docetaxel Injection, HRS-1167 tablets. Conditions listed: Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06568094","url":"https://clinicaltrials.gov/study/NCT06568094"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["prednisone","docetaxel","darolutamide"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06568094","phase":"1/2","setting":"An Open, Multicenter Phase Ib/II Study on the Safety, Tolerability and Efficacy of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2024-09-25","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07389733","kind":"trial","name":"A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of HRS-8080 and Fulvestrant in advanced solid tumours, run by Shandong Suncadia Medicine Co., Ltd., now recruiting.","summary":"A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer is a phase 1/2 interventional study registered as NCT07389733 by Shandong Suncadia Medicine Co., Ltd., with 180 participants planned, started 2026-03-27 and due to reach its primary completion in 2028-12. Interventions recorded: HRS-6208 Capsule, HRS-6209 Capsule, HRS-8080 Tablet, Fulvestrant injection and Letrozole tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07389733","url":"https://clinicaltrials.gov/study/NCT07389733"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["hrs-8080","fulvestrant"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07389733","phase":"1/2","setting":"Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HRS-6208 in Combination With HRS-8080 ± HRS-6209, or in Combination With Fulvestrant ± HRS-6209, or in Combination With Letrozole ± HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer: an Open Label, Multicenter, Phase Ib/II Study","sponsor":"Shandong Suncadia Medicine Co., Ltd.","started":"2026-03-27","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06147570","kind":"trial","name":"A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of HS-10365 capsules in non-small-cell lung cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT06147570 by Jiangsu Hansoh Pharmaceutical Co., Ltd., with 62 participants planned, started 2023-09-25 and due to reach its primary completion in 2027-08-31. Interventions recorded: HS-10365 capsules.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06147570","url":"https://clinicaltrials.gov/study/NCT06147570"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","ret-fusion-nsclc"],"sections":[],"technologies":[],"targets":["ret"],"drugs":[],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06147570","phase":"2","setting":"A Phase II, Open-label, Multicenter Study to Evaluate the Efficacy，Safety and Pharmacokinetics of HS-10365 as First-Line Treatment for Patients With Locally Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","started":"2023-09-25","startedType":"actual","enrolled":62,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07468851","kind":"trial","name":"A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy","aka":[],"tldr":"A phase 1/2 trial of HS-10566 in bladder & urothelial cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy is a phase 1/2 interventional study registered as NCT07468851 by Jiangsu Hansoh Pharmaceutical Co., Ltd., with 180 participants planned, started 2026-08-05 and due to reach its primary completion in 2028-04-30. Interventions recorded: HS-10566.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07468851","url":"https://clinicaltrials.gov/study/NCT07468851"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07468851","phase":"1/2","setting":"A Phase I/II Clinical Study Evaluating the Safety, Efficacy, Tolerability, and Pharmacokinetics of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","started":"2026-08-05","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06526624","kind":"trial","name":"A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer","aka":["ARTEMIS-009"],"tldr":"A phase 3 trial of HS-20093 in lung cancer, run by Hansoh BioMedical R&D Company, not yet recruiting.","summary":"A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT06526624 by Hansoh BioMedical R&D Company, with a registry enrolment figure of 406 participants, started 2024-09-30 and due to reach its primary completion in 2027-11-30. Interventions recorded: HS-20093. Conditions listed: Limited-stage Small-cell Lung Cancer. Primary outcome: Progression-free survival (PFS) According to RECIST v1.1 by Independent Review Committee (IRC); Overall survival (OS). Lung eligibility wording from the registry: \"Patients with limited-stage SCLC who are deemed unsuitable for surgery or decline surgery\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06526624","url":"https://clinicaltrials.gov/study/NCT06526624"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["limited-stage-sclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["hs-20093"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06526624","phase":"3","setting":"ARTEMIS-009: A Phase 3, Randomized, Controlled, Multi-center, Open-label Study of HS-20093 Versus Active Surveillance As Consolidation Therapy After Chemoradiotherapy in Subjects With Limited-Stage Small Cell Lung Cancer","sponsor":"Hansoh BioMedical R&D Company","started":"2024-09-30","startedType":"estimated","enrolled":406,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06417008","kind":"trial","name":"A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2/3 trial testing HS-20117 in non-small-cell lung cancer, now recruiting.","summary":"A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer is a phase 2/3 interventional study registered as NCT06417008, led by Hansoh BioMedical R&D, and recruiting on the registry. Official title: A Phase Ib/III Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Immunogenicity of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer. Planned enrolment is 1080 participants (estimated). The study started in 2024-05-28 and primary completion is expected in 2026-06-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06417008","url":"https://clinicaltrials.gov/study/NCT06417008"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["hs-20117"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06417008","phase":"2/3","setting":"A Phase Ib/III Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Immunogenicity of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer","sponsor":"Hansoh BioMedical R&D","started":"2024-05-28","startedType":"actual","enrolled":1080,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05662397","kind":"trial","name":"A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody","aka":[],"tldr":"A phase 1/2 trial of Cemiplimab in advanced solid tumours, run by HotSpot Therapeutics, Inc, active and no longer recruiting.","summary":"A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody is a phase 1/2 interventional study registered as NCT05662397 by HotSpot Therapeutics, Inc, with 77 participants enrolled, started 2023-03-15 and due to reach its primary completion in 2025-12-31. Interventions recorded: HST-1011 and Cemiplimab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05662397","url":"https://clinicaltrials.gov/study/NCT05662397"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cemiplimab","hst-1011"],"companies":["hotspot-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05662397","phase":"1/2","setting":"An Open Label, Phase 1/2 Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Advanced Solid Tumors","sponsor":"HotSpot Therapeutics, Inc","started":"2023-03-15","startedType":"actual","enrolled":77,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05652894","kind":"trial","name":"A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 3 trial of Pucotenlimab, run by Taizhou Hanzhong biomedical co. LTD in colorectal cancer, active.","summary":"A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer is a phase 3 interventional study registered as NCT05652894 by Taizhou Hanzhong biomedical co. LTD, with 190 participants planned, started 2023-02-28. Conditions listed: Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05652894","url":"https://clinicaltrials.gov/study/NCT05652894"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pucotenlimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05652894","phase":"3","setting":"A Randomized Phase III Study of HX008 (a Humanized Monoclonal Antibody Against PD-1) Compared to Investigator's Choice Chemotherapy in the First-Line Treatment of Subjects With Microsatellite Instability-High (MSI-H)/Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer","sponsor":"Taizhou Hanzhong biomedical co. LTD","started":"2023-02-28","startedType":"actual","enrolled":190,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06362252","kind":"trial","name":"A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-","aka":["IDeate-Lung03"],"tldr":"A phase 1/2 trial of Ifinatamab deruxtecan, Atezolizumab, Carboplatin in small-cell lung cancer, run by Daiichi Sankyo, now recruiting.","summary":"A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03) is a phase 1/2 interventional study registered as NCT06362252 by Daiichi Sankyo, with 123 participants planned, started 2024-07-22 and due to reach its primary completion in 2026-09-30. Interventions recorded: Ifinatamab deruxtecan, Atezolizumab, Carboplatin. Conditions listed: Extensive Stage-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06362252","url":"https://clinicaltrials.gov/study/NCT06362252"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["adc","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["ifinatamab-deruxtecan","atezolizumab","carboplatin"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06362252","phase":"1/2","setting":"A Phase 1b/2, Multicenter, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody-Drug Conjugate (ADC), in Combination With Atezolizumab With or Without Carboplatin as First-line Induction or Maintenance, in Subjects With Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung03)","sponsor":"Daiichi Sankyo","started":"2024-07-22","startedType":"actual","enrolled":123,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06083207","kind":"trial","name":"A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 1/2 trial of IBI3003 in multiple myeloma, run by Innovent Biologics (Suzhou) Co. Ltd., now recruiting.","summary":"A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT06083207 by Innovent Biologics (Suzhou) Co. Ltd., with 116 participants planned, started 2024-07-29 and due to reach its primary completion in 2026-10-31. Interventions recorded: IBI3003.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06083207","url":"https://clinicaltrials.gov/study/NCT06083207"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06083207","phase":"1/2","setting":"A Phase I/II, Multicenter, Open-label, First-in-human Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","started":"2024-07-29","startedType":"actual","enrolled":116,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06081920","kind":"trial","name":"A Study of IBI363 in Subjects With Advanced Melanoma","aka":[],"tldr":"A phase 2 trial of IBI363 in melanoma, run by Innovent Biologics (Suzhou) Co. Ltd., now recruiting.","summary":"A Study of IBI363 in Subjects With Advanced Melanoma is a phase 2 interventional study registered as NCT06081920 by Innovent Biologics (Suzhou) Co. Ltd., with 180 participants planned, started 2023-10-19 and due to reach its primary completion in 2028-10-19. Interventions recorded: IBI363. Conditions listed: Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06081920","url":"https://clinicaltrials.gov/study/NCT06081920"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["ibi363"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06081920","phase":"2","setting":"A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects With Advanced Melanoma","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","started":"2023-10-19","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06281678","kind":"trial","name":"A Study of IBI363 in Subjects with Advanced Solid Malignancies","aka":[],"tldr":"A phase 2 trial of IBI363 in melanoma and non-small-cell lung cancer, run by Innovent Biologics (Suzhou) Co. Ltd., now recruiting.","summary":"A Study of IBI363 in Subjects with Advanced Solid Malignancies is a phase 2 interventional study registered as NCT06281678 by Innovent Biologics (Suzhou) Co. Ltd., with 178 participants planned, started 2024-04-08 and due to reach its primary completion in 2026-03-01. Interventions recorded: IBI363. Conditions listed: Melanoma, Non-small Cell Lung Cancer, Colorectal Cancer, Renal Cell Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06281678","url":"https://clinicaltrials.gov/study/NCT06281678"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","nsclc","sclc","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["ibi363"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06281678","phase":"2","setting":"A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","started":"2024-04-08","startedType":"actual","enrolled":178,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07087158","kind":"trial","name":"A Study of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma","aka":[],"tldr":"A phase 2 trial of Pazopanib in renal cell carcinoma, run by Imbioray (Hangzhou) Biomedicine Co., Ltd., now recruiting.","summary":"A Study of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma is a phase 2 interventional study registered as NCT07087158 by Imbioray (Hangzhou) Biomedicine Co., Ltd., with 30 participants planned, started 2025-09-08 and due to reach its primary completion in 2026-12-31. Interventions recorded: IBR854, Pazopanib. Conditions listed: Renal Cell Carcinoma (RCC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07087158","url":"https://clinicaltrials.gov/study/NCT07087158"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["pazopanib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07087158","phase":"2","setting":"A Multicenter, Randomized, Open-Label, Active-Controlled Phase II Study Evaluating the Efficacy and Safety of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma","sponsor":"Imbioray (Hangzhou) Biomedicine Co., Ltd.","started":"2025-09-08","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05678270","kind":"trial","name":"A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma","aka":[],"tldr":"A phase 2 trial of ICP-192 in biliary tract cancer, run by Beijing InnoCare Pharma Tech Co., Ltd., now recruiting.","summary":"A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma is a phase 2 interventional study registered as NCT05678270 by Beijing InnoCare Pharma Tech Co., Ltd., with 70 participants planned, started 2022-11-15 and due to reach its primary completion in 2026-05. Interventions recorded: ICP-192.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05678270","url":"https://clinicaltrials.gov/study/NCT05678270"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":["fgfr2"],"drugs":[],"companies":["innocare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05678270","phase":"2","setting":"A Single-Arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of ICP-192 in Subjects With Unresectable or Metastatic Intrahepatic Cholangiocarcinoma With FGFR2 Fusions/Rearrangements Who Have Failed Prior Therapy","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","started":"2022-11-15","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07174583","kind":"trial","name":"A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of Durvalumab, Carboplatin in small-cell lung cancer, run by IDEAYA Biosciences, now recruiting.","summary":"A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT07174583 by IDEAYA Biosciences, with 262 participants planned, started 2025-10-14 and due to reach its primary completion in 2029-07. Interventions recorded: IDE849, durvalumab, IDE161, Carboplatin. Conditions listed: Small-cell Lung Cancer, Neuroendocrine Carcinomas, Solid Tumor Show to Express DLL3. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07174583","url":"https://clinicaltrials.gov/study/NCT07174583"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["durvalumab","carboplatin"],"companies":["ideaya-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07174583","phase":"1/2","setting":"A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE849 in Patients With DLL3-Expressing Tumors Including Small Cell Lung Cancer","sponsor":"IDEAYA Biosciences","started":"2025-10-14","startedType":"actual","enrolled":262,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07602842","kind":"trial","name":"A Study of IDP-001 in Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of IDP-001 in head and neck squamous cell carcinoma, cutaneous squamous cell carcinoma, cervical cancer, non-small-cell lung cancer and oesophageal cancer, run by InduPro, Inc., now recruiting.","summary":"A Study of IDP-001 in Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT07602842 by InduPro, Inc., with 132 participants planned, started 2026-07-08 and due to reach its primary completion in 2028-06. Interventions recorded: IDP-001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07602842","url":"https://clinicaltrials.gov/study/NCT07602842"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","cutaneous-scc","cervical","nsclc","esophageal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07602842","phase":"1/2","setting":"A Phase 1/2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors","sponsor":"InduPro, Inc.","started":"2026-07-08","startedType":"actual","enrolled":132,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07218926","kind":"trial","name":"A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy","aka":["StrateGIST 3"],"tldr":"A phase 3 trial testing IDRX-42 in gastrointestinal stromal tumour, now recruiting.","summary":"A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumours After Imatinib Therapy is a phase 3 interventional study registered as NCT07218926, led by GlaxoSmithKline, and recruiting on the registry. Official title: A Phase 3, Randomised, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) Versus Sunitinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumours (GIST) After Imatinib Therapy (StrateGIST 3). Planned enrolment is 450 participants (estimated). The study started in 2025-12-03 and primary completion is expected in 2028-05-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07218926","url":"https://clinicaltrials.gov/study/NCT07218926"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gist","gist-imatinib-resistant"],"sections":[],"technologies":[],"targets":[],"drugs":["idrx-42"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07218926","phase":"3","setting":"A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) Versus Sunitinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib Therapy (StrateGIST 3)","sponsor":"GlaxoSmithKline","started":"2025-12-03","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07630974","kind":"trial","name":"A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)","aka":["LIGHTBEAM-U01"],"tldr":"A phase 1/2 trial of Ifinatamab deruxtecan in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01) is a phase 1/2 interventional study registered as NCT07630974 by Merck Sharp & Dohme LLC, with 134 participants planned, started 2026-07-06 and due to reach its primary completion in 2031-08-17. Interventions recorded: Ifinatamab Deruxtecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07630974","url":"https://clinicaltrials.gov/study/NCT07630974"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["ifinatamab-deruxtecan"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07630974","phase":"1/2","setting":"LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors","sponsor":"Merck Sharp & Dohme LLC","started":"2026-07-06","startedType":"actual","enrolled":134,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06644781","kind":"trial","name":"A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)","aka":["IDeate-Esophageal01"],"tldr":"A phase 3 trial of Ifinatamab deruxtecan and Docetaxel in oesophageal cancer, run by Daiichi Sankyo, now recruiting.","summary":"A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01) is a phase 3 interventional study registered as NCT06644781 by Daiichi Sankyo, with 510 participants planned, started 2025-03-27 and due to reach its primary completion in 2028-06-01. Interventions recorded: Ifinatamab deruxtecan, Docetaxel, Paclitaxel and Irinotecan hydrochloride (HCl).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06644781","url":"https://clinicaltrials.gov/study/NCT06644781"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal","oesophageal-squamous-cell-carcinoma"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["ifinatamab-deruxtecan","docetaxel"],"companies":["daiichi-sankyo","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06644781","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)","sponsor":"Daiichi Sankyo","started":"2025-03-27","startedType":"actual","enrolled":510,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06365840","kind":"trial","name":"A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor","aka":[],"tldr":"A phase 2 trial of IMC-001 in advanced solid tumours, run by ImmuneOncia Therapeutics Inc., now recruiting.","summary":"A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor is a phase 2 interventional study registered as NCT06365840 by ImmuneOncia Therapeutics Inc., with 30 participants planned, started 2025-01-13 and due to reach its primary completion in 2027-06-30. Interventions recorded: IMC-001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06365840","url":"https://clinicaltrials.gov/study/NCT06365840"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["immuneoncia-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06365840","phase":"2","setting":"PHASE 2 STUDY OF IMC-001 IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED TMB-H SOLID TUMOR","sponsor":"ImmuneOncia Therapeutics Inc.","started":"2025-01-13","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04414163","kind":"trial","name":"A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type","aka":[],"tldr":"A phase 2 trial of IMC-001 in peripheral T-cell lymphomas, run by ImmuneOncia Therapeutics Inc., active and no longer recruiting.","summary":"A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type is a phase 2 interventional study registered as NCT04414163 by ImmuneOncia Therapeutics Inc., with 23 participants enrolled, started 2020-10-27 and due to reach its primary completion in 2024-07-23. Interventions recorded: IMC-001.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04414163","url":"https://clinicaltrials.gov/study/NCT04414163"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["immuneoncia-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04414163","phase":"2","setting":"An Open-label, Single-arm, Phase 2 Study to Investigate the Efficacy and Safety of IMC-001 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type","sponsor":"ImmuneOncia Therapeutics Inc.","started":"2020-10-27","startedType":"actual","enrolled":23,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07287098","kind":"trial","name":"A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer","aka":["preEMBER"],"tldr":"A phase 2 trial of Imlunestrant and Tamoxifen in HR-positive / HER2-negative breast cancer, run by Eli Lilly and Company, now recruiting.","summary":"A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer is a phase 2 interventional study registered as NCT07287098 by Eli Lilly and Company, with 600 participants planned, started 2026-05-13 and due to reach its primary completion in 2029-01. Interventions recorded: Imlunestrant, Goserelin and Tamoxifen 20 mg.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07287098","url":"https://clinicaltrials.gov/study/NCT07287098"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["imlunestrant","tamoxifen"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07287098","phase":"2","setting":"preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast Cancer","sponsor":"Eli Lilly and Company","started":"2026-05-13","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05514054","kind":"trial","name":"A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer","aka":["EMBER-4"],"tldr":"A phase 3 trial of Imlunestrant, Tamoxifen and Exemestane in advanced solid tumours, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer is a phase 3 interventional study registered as NCT05514054 by Eli Lilly and Company, with 8000 participants enrolled, started 2022-10-04 and due to reach its primary completion in 2027-10. Interventions recorded: Imlunestrant, Tamoxifen, Anastrozole, Letrozole and Exemestane.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05514054","url":"https://clinicaltrials.gov/study/NCT05514054"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["imlunestrant","tamoxifen","exemestane"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05514054","phase":"3","setting":"EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence","sponsor":"Eli Lilly and Company","started":"2022-10-04","startedType":"actual","enrolled":8000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05805501","kind":"trial","name":"A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cel","aka":[],"tldr":"A phase 2 trial of Tiragolumab, Pembrolizumab, Axitinib in renal cell carcinoma, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma is a phase 2 interventional study registered as NCT05805501 by Hoffmann-La Roche, with 199 participants enrolled, started 2023-04-21 and due to reach its primary completion in 2026-10-08. Interventions recorded: Tobemstomig, Tiragolumab, Pembrolizumab, Axitinib. Conditions listed: Renal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05805501","url":"https://clinicaltrials.gov/study/NCT05805501"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["tiragolumab","pembrolizumab","axitinib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05805501","phase":"2","setting":"A Randomized Open Label Phase II Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma","sponsor":"Hoffmann-La Roche","started":"2023-04-21","startedType":"actual","enrolled":199,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04169997","kind":"trial","name":"A Study of IMP4297 as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer","aka":["FLAMES"],"tldr":"A phase 3 trial testing IMP4927 in ovarian cancer, active and no longer recruiting.","summary":"A Study of IMP4297 as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer is a phase 3 interventional study registered as NCT04169997, led by Impact Therapeutics, and active but no longer recruiting on the registry. Official title: A Phase III Study to Evaluate the Efficacy and Safety of IMP4297 Following 1st Line Chemotherapy in the Monotherapy Maintenance Treatment of Subjects With Ovarian Cancer. Planned enrolment is 404 participants (actual). The study started in 2019-12-24 and primary completion is expected in 2023-03-16. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04169997","url":"https://clinicaltrials.gov/study/NCT04169997"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["imp4927"],"companies":["impact-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04169997","phase":"3","setting":"A Phase III Study to Evaluate the Efficacy and Safety of IMP4297 Following 1st Line Chemotherapy in the Monotherapy Maintenance Treatment of Subjects With Ovarian Cancer","sponsor":"Impact Therapeutics","started":"2019-12-24","startedType":"actual","enrolled":404,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07023627","kind":"trial","name":"A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression","aka":["MAESTRA 1"],"tldr":"A phase 2 trial of INCB123667 in ovarian cancer, run by Incyte Corporation, now recruiting.","summary":"A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression is a phase 2 interventional study registered as NCT07023627 by Incyte Corporation, with 160 participants planned, started 2025-11-12 and due to reach its primary completion in 2027-04-27. Interventions recorded: INCB123667. Conditions listed: Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07023627","url":"https://clinicaltrials.gov/study/NCT07023627"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["incb123667"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07023627","phase":"2","setting":"A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1)","sponsor":"Incyte Corporation","started":"2025-11-12","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05957367","kind":"trial","name":"A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies","aka":[],"tldr":"A phase 1/2 trial of Ripretinib in advanced solid tumours, run by Deciphera Pharmaceuticals, LLC, now recruiting.","summary":"A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies is a phase 1/2 interventional study registered as NCT05957367 by Deciphera Pharmaceuticals, LLC, with 94 participants planned, started 2023-09-28 and due to reach its primary completion in 2027-03. Interventions recorded: Inlexisertib and Ripretinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05957367","url":"https://clinicaltrials.gov/study/NCT05957367"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ripretinib","inlexisertib"],"companies":["deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05957367","phase":"1/2","setting":"A Master Protocol for the Multi-Cohort, Phase 1/2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies","sponsor":"Deciphera Pharmaceuticals, LLC","started":"2023-09-28","startedType":"actual","enrolled":94,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06077760","kind":"trial","name":"A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (","aka":["INTerpath-002"],"tldr":"A phase 3 trial of Intismeran autogene, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002) is a phase 3 interventional study registered as NCT06077760 by Merck Sharp & Dohme LLC, with 868 participants planned, started 2023-12-06 and due to reach its primary completion in 2030-06-25. Interventions recorded: Intismeran autogene, Pembrolizumab, Placebo. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06077760","url":"https://clinicaltrials.gov/study/NCT06077760"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","neoantigen-mrna-vaccine"],"targets":[],"drugs":["intismeran-autogene","pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registry status on 22 September 2026: Active, not recruiting (registry record last updated 18 September 2026; primary completion expected 25 June 2030)."],"nct":"NCT06077760","phase":"3","setting":"A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)","sponsor":"Merck Sharp & Dohme LLC","started":"2023-12-06","startedType":"actual","enrolled":868,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07221474","kind":"trial","name":"A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)","aka":["INTerpath-013"],"tldr":"A phase 2 trial of Intismeran autogene, Pembrolizumab, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013) is a phase 2 interventional study registered as NCT07221474 by Merck Sharp & Dohme LLC, with 180 participants planned, started 2025-12-12 and due to reach its primary completion in 2029-07-02. Interventions recorded: Intismeran Autogene, Pembrolizumab, Carboplatin, Paclitaxel, Nab-paclitaxel. Conditions listed: Squamous Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07221474","url":"https://clinicaltrials.gov/study/NCT07221474"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor","neoantigen-mrna-vaccine"],"targets":[],"drugs":["intismeran-autogene","pembrolizumab","carboplatin","paclitaxel"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07221474","phase":"2","setting":"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-12-12","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02138734","kind":"trial","name":"A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer","aka":[],"tldr":"A phase 1/2 trial of BCG (50mg/instillation) + N-803 (400 μg/instillation) in bladder & urothelial cancer, run by ImmunityBio, Inc., active and no longer recruiting.","summary":"A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer is a phase 1/2 interventional study registered as NCT02138734 by ImmunityBio, Inc., with 369 participants enrolled, started 2014-07-21 and due to reach its primary completion in 2026-09-30. Interventions recorded: BCG (50mg/instillation) + N-803 (400 μg/instillation) and BCG (50mg/instillation).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02138734","url":"https://clinicaltrials.gov/study/NCT02138734"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["nogapendekin-alfa"],"companies":["immunitybio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02138734","phase":"1/2","setting":"A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With Non-Muscle Invasive Bladder Cancer","sponsor":"ImmunityBio, Inc.","started":"2014-07-21","startedType":"actual","enrolled":369,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07122414","kind":"trial","name":"A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer","aka":[],"tldr":"A phase 1/2 trial of FL115 in bladder & urothelial cancer, run by Suzhou Forlong Biotechnology Co., Ltd, now recruiting.","summary":"A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer is a phase 1/2 interventional study registered as NCT07122414 by Suzhou Forlong Biotechnology Co., Ltd, with 80 participants planned, started 2024-08-16 and due to reach its primary completion in 2027-10-10. Interventions recorded: FL115 and FL115+BCG.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07122414","url":"https://clinicaltrials.gov/study/NCT07122414"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["suzhou-forlong-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07122414","phase":"1/2","setting":"A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Intravesical FL115 Alone or in Combination With BCG in Subjects With Non-Muscle Invasive Bladder Cancer, Including Dose Escalation and Cohort Expansion","sponsor":"Suzhou Forlong Biotechnology Co., Ltd","started":"2024-08-16","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07424287","kind":"trial","name":"A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC","aka":["NiBladder 1"],"tldr":"A phase 3 trial testing SHR-1501 in bladder & urothelial cancer, now recruiting.","summary":"A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC is a phase 3 interventional study registered as NCT07424287, led by Suzhou Suncadia Biopharmaceuticals, and recruiting on the registry. Official title: A Multicenter, Randomised, Open-label Phase III Clinical Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Investigator-selected Chemotherapy In Patients With BCG-unresponsive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC) (NiBladder 1). Planned enrolment is 236 participants (estimated). The study started in 2026-07-13 and primary completion is expected in 2030-06. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07424287","url":"https://clinicaltrials.gov/study/NCT07424287"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-1501","pirarubicin"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07424287","phase":"3","setting":"A Multicenter, Randomized, Open-label Phase III Clinical Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Investigator-selected Chemotherapy In Patients With BCG-unresponsive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC) (NiBladder 1)","sponsor":"Suzhou Suncadia Biopharmaceuticals","started":"2026-07-13","startedType":"actual","enrolled":236,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06780085","kind":"trial","name":"A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)","aka":["KEYMAKER-U01"],"tldr":"A phase 2 trial of Raludotatug deruxtecan and Ifinatamab deruxtecan in non-small-cell lung cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01) is a phase 2 interventional study registered as NCT06780085 by Merck Sharp & Dohme LLC, with 96 participants planned, started 2025-05-13 and due to reach its primary completion in 2032-03-12. Interventions recorded: Raludotatug Deruxtecan, Ifinatamab Deruxtecan, Docetetaxel, 5-hydroxytryptamine subtype 3 receptor antagonist, Neurokinin-1 receptor antagonist and Corticosteroid.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06780085","url":"https://clinicaltrials.gov/study/NCT06780085"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["raludotatug-deruxtecan","ifinatamab-deruxtecan"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06780085","phase":"2","setting":"KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-05-13","startedType":"actual","enrolled":96,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06827613","kind":"trial","name":"A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors","aka":["START-002"],"tldr":"A phase 1/2 trial of Sacituzumab govitecan in advanced solid tumours, run by Marengo Therapeutics, Inc., now recruiting.","summary":"A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06827613 by Marengo Therapeutics, Inc., with 50 participants planned, started 2025-03-24 and due to reach its primary completion in 2027-01. Interventions recorded: STAR0602 and Sacituzumab Govitecan (SG).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06827613","url":"https://clinicaltrials.gov/study/NCT06827613"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":["marengo-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06827613","phase":"1/2","setting":"A Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Unresectable, Locally Advanced, or Metastatic Solid Tumors (START-002)","sponsor":"Marengo Therapeutics, Inc.","started":"2025-03-24","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07743723","kind":"trial","name":"A Study of IOV-5001 in Adults With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial in triple-negative breast cancer, run by Iovance Biotherapeutics, Inc., not yet recruiting.","summary":"A Study of IOV-5001 in Adults With Advanced Solid Tumors is a phase 1/2, interventional study registered as NCT07743723 by Iovance Biotherapeutics, Inc., with a registry enrolment figure of 106 participants, started 2026-09 and due to reach its primary completion in 2034-03. Interventions recorded: IOV-5001. Conditions listed: Advanced Solid Tumors; Non-Small Cell Lung Cancer; Triple Negative Breast Cancer (TNBC); Colorectal Cancer; Head and Neck Squamous Cell Carcinoma; Metastatic Solid Tumors; Unresectable Solid Tumor. Triple-negative eligibility wording from the registry: \"TNBC: Participant has a histologically or pathologically confirmed diagnosis of unresectable or Stage IV breast cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07743723","url":"https://clinicaltrials.gov/study/NCT07743723"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["iovance"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07743723","phase":"1/2","setting":"A Phase 1/2, Multicenter, Multi-cohort, Open-label Study of an Autologous Tumor-infiltrating Lymphocytes (TIL) Regimen With IOV-5001 in Participants With Previously Treated Advanced Solid Tumors","sponsor":"Iovance Biotherapeutics, Inc.","started":"2026-09","startedType":"estimated","enrolled":106,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07535437","kind":"trial","name":"A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of ivonescimab, datopotamab deruxtecan and osimertinib in lung cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer is a phase 1/2, interventional study registered as NCT07535437 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 66 participants, started 2026-04-09 and due to reach its primary completion in 2028-04. Interventions recorded: Ivonescimab; Dato-DXd; Osimertinib. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: determine the maximum tolerated dose (MTD) (phase I); progression free survival (phase I); measure objective response rate (ORR) (phase II). Lung eligibility wording from the registry: \"* Biopsy-proven metastatic non-small cell lung cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07535437","url":"https://clinicaltrials.gov/study/NCT07535437"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["adc","antiangiogenic","bispecific-antibody","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["ivonescimab","datopotamab-deruxtecan","osimertinib"],"companies":["summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07535437","phase":"1/2","setting":"A Phase 1/2 Trial of Ivonescimab With Dato-DXd or Osimertinib in Patients With Metastatic EGFR-mutant Non-small Cell Lung Cancer That Progressed on EGFR TKI Therapy","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2026-04-09","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07815665","kind":"trial","name":"A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma","aka":["HARMONi-GU1"],"tldr":"A phase 2/3 trial of Ivonescimab, Enfortumab vedotin and Pembrolizumab in bladder & urothelial cancer, run by Summit Therapeutics, now recruiting.","summary":"A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma is a phase 2/3 interventional study registered as NCT07815665 by Summit Therapeutics, with 800 participants planned, started 2026-09-10 and due to reach its primary completion in 2030-10-31. Interventions recorded: Ivonescimab Dose 1, enfortumab vedotin (EV), Pembrolizumab, Ivonescimab Dose 2 and Ivonescimab RP3D.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07815665","url":"https://clinicaltrials.gov/study/NCT07815665"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc","bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab","enfortumab-vedotin","pembrolizumab"],"companies":["summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07815665","phase":"2/3","setting":"A Randomized Phase 2/3 Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (HARMONi-GU1)","sponsor":"Summit Therapeutics","started":"2026-09-10","startedType":"estimated","enrolled":800,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07245446","kind":"trial","name":"A Study of Ivonescimab in First-Line ES-SCLC","aka":[],"tldr":"A phase 2 trial of Ivonescimab, Cadonilimab, AK117 in small-cell lung cancer, run by Akeso, now recruiting.","summary":"A Study of Ivonescimab in First-Line ES-SCLC is a phase 2 interventional study registered as NCT07245446 by Akeso, with 180 participants planned, started 2025-10-29 and due to reach its primary completion in 2027-12. Interventions recorded: Ivonescimab, Cadonilimab, AK117, Etoposide, Carboplatin (AUC 5). Conditions listed: Extensive-stage Small Cell Lung Cancer (ES-SCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07245446","url":"https://clinicaltrials.gov/study/NCT07245446"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab","cadonilimab","ak117","etoposide","carboplatin"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07245446","phase":"2","setting":"A Phase II Clinical Study of Ivonescimab Combination Therapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)","sponsor":"Akeso","started":"2025-10-29","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07535463","kind":"trial","name":"A Study of Ivonescimab, Chemotherapy, and Stereotactic Radiosurgery for People With Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of ivonescimab in lung cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"A Study of Ivonescimab, Chemotherapy, and Stereotactic Radiosurgery for People With Non-Small Cell Lung Cancer is a phase 1/2, interventional study registered as NCT07535463 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 53 participants, started 2026-04-10 and due to reach its primary completion in 2028-04. Interventions recorded: Ivonescimab; Stereotactic Radiosurgery. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: identify the Recommended Phase 2 Dose (RPD2); intracranial progression-free survival (iPFS),. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed non-small cell lung cancer, including squamous and non-squamous histologies\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07535463","url":"https://clinicaltrials.gov/study/NCT07535463"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","bispecific-antibody","checkpoint-inhibitor","sbrt"],"targets":[],"drugs":["ivonescimab"],"companies":["summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07535463","phase":"1/2","setting":"Safety and Efficacy of Ivonescimab and Chemotherapy Plus Stereotactic Radiosurgery (SRS) in the Treatment of Non-Small Cell Lung Cancer Brain Metastases","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2026-04-10","startedType":"actual","enrolled":53,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00883116","kind":"trial","name":"A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer","aka":["IXAMPLE2"],"tldr":"A phase 3 trial of Ixabepilone, Doxorubicin and Paclitaxel / nab-paclitaxel in Endometrial cancer, run by R-Pharm, recorded as terminated on the registry.","summary":"A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer is a phase 3 interventional study registered as NCT00883116 by R-Pharm, with 551 participants recorded, started 2009-08 and due to reach its primary completion in 2012-06. Interventions recorded: Ixabepilone, Doxorubicin, Paclitaxel. Conditions recorded: Endometrial Cancer.\n\nLinked to the drug Ixabepilone because the registry names it among its interventions and Endometrial cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00883116","url":"https://clinicaltrials.gov/study/NCT00883116"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ixabepilone","doxorubicin","paclitaxel"],"companies":["r-pharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00883116","phase":"3","setting":"A Phase III, Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxorubicin Administered Every 21 Days in Women With Advanced Endometrial Cancer Who Have Previously Been Treated With Chemotherapy","sponsor":"R-Pharm","started":"2009-08","yearReported":2014,"enrolled":551,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Ixabepilone, 40 mg/m^2, Intravenously (IV)","n":248,"value":10.9,"note":"95% CI 8.5 to 12.7; Figures from the ClinicalTrials.gov results section (first posted 2014-03-14), not from a publication"},{"name":"Control With Chemotherapy (Paclitaxel or Doxorubicin)","n":248,"value":12.3,"note":"95% CI 10.7 to 15.4"}],"hr":1.3,"ci":[1,1.7],"p":"0.0397","source":"https://clinicaltrials.gov/study/NCT00883116?tab=results"},{"endpoint":"Progression-free Survival","unit":"months","arms":[{"name":"Ixabepilone, 40 mg/m^2, Intravenously (IV)","n":223,"value":3.4,"note":"95% CI 2.8 to 4.2; Figures from the ClinicalTrials.gov results section (first posted 2014-03-14), not from a publication"},{"name":"Control With Chemotherapy (Paclitaxel or Doxorubicin)","n":223,"value":4,"note":"95% CI 2.7 to 4.3"}],"hr":1,"ci":[0.8,1.3],"p":"0.8011","source":"https://clinicaltrials.gov/study/NCT00883116?tab=results"},{"endpoint":"Best Overall Response Rate","unit":"%","arms":[{"name":"Ixabepilone, 40 mg/m^2, Intravenously (IV)","n":223,"value":15.2,"note":"95% CI 10.8 to 20.6; Figures from the ClinicalTrials.gov results section (first posted 2014-03-14), not from a publication"},{"name":"Control With Chemotherapy (Paclitaxel or Doxorubicin)","n":223,"value":15.7,"note":"95% CI 11.2 to 21.1"}],"source":"https://clinicaltrials.gov/study/NCT00883116?tab=results"}]},{"id":"nct05009329","kind":"trial","name":"A Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation in China","aka":[],"tldr":"A phase 1/2 trial of Glecirasib in non-small-cell lung cancer, run by Allist Pharmaceuticals, Inc., active and no longer recruiting.","summary":"A Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation in China is a phase 1/2 interventional study registered as NCT05009329 by Allist Pharmaceuticals, Inc., with 315 participants enrolled, started 2021-07-26 and due to reach its primary completion in 2026-08. Interventions recorded: JAB-21822.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05009329","url":"https://clinicaltrials.gov/study/NCT05009329"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":["kinase-inhibitors","kras-inhibitors"],"targets":[],"drugs":["glecirasib"],"companies":["allist"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05009329-nat-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05009329","phase":"1/2","setting":"Multi-center, Open, Dose-escalation, and Expanded Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JAB-21822 in Advanced Solid Tumors With KRAS p.G12C Mutation","sponsor":"Allist Pharmaceuticals, Inc.","started":"2021-07-26","startedType":"actual","enrolled":315,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05276726","kind":"trial","name":"A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1","aka":[],"tldr":"A phase 1/2 trial of Glecirasib in non-small-cell lung cancer and small-cell lung cancer, run by Allist Pharmaceuticals, Inc., now recruiting.","summary":"A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1 is a phase 1/2 interventional study registered as NCT05276726 by Allist Pharmaceuticals, Inc., with 104 participants planned, started 2022-08-17 and due to reach its primary completion in 2027-08. Interventions recorded: JAB 21822. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05276726","url":"https://clinicaltrials.gov/study/NCT05276726"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","kras-g12c-nsclc"],"sections":[],"technologies":["kinase-inhibitors","kras-inhibitors"],"targets":[],"drugs":["glecirasib"],"companies":["allist"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05276726","phase":"1/2","setting":"A Phase Ib/II ,Single Arm, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of JAB-21822 in Advanced or Metastatic Non-small Cell Lung Cancer With a KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1","sponsor":"Allist Pharmaceuticals, Inc.","started":"2022-08-17","startedType":"actual","enrolled":104,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06868849","kind":"trial","name":"A Study of JMT203 in Patients With Cancer Cachexia","aka":[],"tldr":"A phase 1/2 trial of JMT203 Injection in non-small-cell lung cancer, pancreatic ductal adenocarcinoma and colorectal cancer, run by Shanghai JMT-Bio Inc., now recruiting.","summary":"A Study of JMT203 in Patients With Cancer Cachexia is a phase 1/2 interventional study registered as NCT06868849 by Shanghai JMT-Bio Inc., with 307 participants planned, started 2024-05-15 and due to reach its primary completion in 2027-08-14. Interventions recorded: JMT203 Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06868849","url":"https://clinicaltrials.gov/study/NCT06868849"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","pancreatic","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["jmt203"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06868849","phase":"1/2","setting":"A Phase Ia/II, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients With Cancer Cachexia","sponsor":"Shanghai JMT-Bio Inc.","started":"2024-05-15","startedType":"actual","enrolled":307,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04133636","kind":"trial","name":"A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Mul","aka":["CARTITUDE-2"],"tldr":"A phase 2 trial of Ciltacabtagene autoleucel, Lenalidomide, Daratumumab in multiple myeloma, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma is a phase 2 interventional study registered as NCT04133636 by Janssen Research & Development, LLC, with 208 participants enrolled, started 2019-11-07 and due to reach its primary completion in 2027-02-26. Interventions recorded: JNJ-68284528, Lenalidomide, Daratumumab, Bortezomib, Dexamethasone. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04133636","url":"https://clinicaltrials.gov/study/NCT04133636"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["ciltacabtagene-autoleucel","lenalidomide","daratumumab","bortezomib","dexamethasone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04133636","phase":"2","setting":"68284528MMY2003: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma","sponsor":"Janssen Research & Development, LLC","started":"2019-11-07","startedType":"actual","enrolled":208,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07266441","kind":"trial","name":"A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma","aka":["TRIlogy-3"],"tldr":"A phase 2 trial of JNJ-79635322 in multiple myeloma, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT07266441 by Janssen Research & Development, LLC, with 157 participants planned, started 2026-02-08 and due to reach its primary completion in 2027-06-14. Interventions recorded: JNJ-79635322. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07266441","url":"https://clinicaltrials.gov/study/NCT07266441"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["jnj-79635322"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07266441","phase":"2","setting":"A Phase 2, Open-label Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody","sponsor":"Janssen Research & Development, LLC","started":"2026-02-08","startedType":"actual","enrolled":157,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05421663","kind":"trial","name":"A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma","aka":[],"tldr":"A phase 1/2 trial of JNJ-90014496 in non-hodgkin lymphoma, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma is a phase 1/2 interventional study registered as NCT05421663 by Janssen Research & Development, LLC, with 166 participants enrolled, started 2022-08-12 and due to reach its primary completion in 2041-07-30. Interventions recorded: JNJ-90014496. Conditions listed: Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05421663","url":"https://clinicaltrials.gov/study/NCT05421663"}],"tags":["ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["jnj-90014496"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05421663","phase":"1/2","setting":"A Phase 1b/2, Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants With B-cell Non-Hodgkin Lymphoma","sponsor":"Janssen Research & Development, LLC","started":"2022-08-12","startedType":"actual","enrolled":166,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06667908","kind":"trial","name":"A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)","aka":["CONVERGE"],"tldr":"A phase 2 trial of JNJ-90301900, Durvalumab and Carboplatin in non-small-cell lung cancer, run by Johnson & Johnson Enterprise Innovation Inc., now recruiting.","summary":"A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC) is a phase 2 interventional study registered as NCT06667908 by Johnson & Johnson Enterprise Innovation Inc., with 130 participants planned, started 2024-12-06 and due to reach its primary completion in 2028-12-31. Interventions recorded: JNJ-90301900, Durvalumab, Concurrent Chemo/Radiation Therapy (cCRT), Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin and Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06667908","url":"https://clinicaltrials.gov/study/NCT06667908"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["jnj-90301900","durvalumab","carboplatin"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06667908","phase":"2","setting":"A Phase 2, Randomized, Open-Label, Active-Controlled Study of JNJ-90301900 in Combination With Chemoradiation Followed by Durvalumab in Locally Advanced and Unresectable Stage III NSCLC","sponsor":"Johnson & Johnson Enterprise Innovation Inc.","started":"2024-12-06","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07047118","kind":"trial","name":"A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)","aka":[],"tldr":"A phase 2 trial of JSB462 in prostate cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) is a phase 2 interventional study registered as NCT07047118 by Novartis Pharmaceuticals, with 138 participants enrolled, started 2025-07-03 and due to reach its primary completion in 2027-07-16. Interventions recorded: JSB462 and AAA617.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07047118","url":"https://clinicaltrials.gov/study/NCT07047118"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["advanced-accelerator-applications"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07047118","phase":"2","setting":"A Phase II, Randomized, Open-label, Multi-center Study of JSB462 (Luxdegalutamide) in Combination With Lutetium (177Lu) Vipivotide Tetraxetan in Adult Male Patients With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)","sponsor":"Novartis Pharmaceuticals","started":"2025-07-03","startedType":"actual","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06564272","kind":"trial","name":"A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma","aka":[],"tldr":"A phase 2 trial of KC1036 in ewing sarcoma, run by Beijing Konruns Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma is a phase 2 interventional study registered as NCT06564272 by Beijing Konruns Pharmaceutical Co., Ltd., with 30 participants planned, started 2024-09-27 and due to reach its primary completion in 2027-04-01. Interventions recorded: KC1036. Conditions listed: Ewing Sarcoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06564272","url":"https://clinicaltrials.gov/study/NCT06564272"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ewing-sarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["kc1036"],"companies":["beijing-konruns-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06564272","phase":"2","setting":"A Phase II Study to Evaluate the Safety and Efficacy of KC1036 in Adolescents Aged 12 and Above With Advanced Ewing Sarcoma","sponsor":"Beijing Konruns Pharmaceutical Co., Ltd.","started":"2024-09-27","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05683886","kind":"trial","name":"A Study of KC1036 in Patients with Advanced Thymic Tumors","aka":[],"tldr":"A phase 2 trial of KC1036 in thymoma and thymic carcinoma, run by Beijing Konruns Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of KC1036 in Patients with Advanced Thymic Tumors is a phase 2 interventional study registered as NCT05683886 by Beijing Konruns Pharmaceutical Co., Ltd., with 30 participants planned, started 2023-02-22 and due to reach its primary completion in 2025-02. Interventions recorded: KC1036.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05683886","url":"https://clinicaltrials.gov/study/NCT05683886"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["thymic-epithelial","thymoma","thymic-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["kc1036"],"companies":["beijing-konruns-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05683886","phase":"2","setting":"A Single-arm, Open, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients with Advanced Recurrent or Metastatic Thymic Tumors","sponsor":"Beijing Konruns Pharmaceutical Co., Ltd.","started":"2023-02-22","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06194734","kind":"trial","name":"A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer","aka":[],"tldr":"A phase 3 trial testing KC1036 in oesophageal cancer, now recruiting.","summary":"A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Oesophageal Cancer is a phase 3 interventional study registered as NCT06194734, led by Beijing Konruns Pharmaceutical, and recruiting on the registry. Official title: A Randomised, Controlled, Open-label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of KC1036 Versus Investigator's Choice of Chemotherapy as Third-line Therapy in Patients With Advanced Oesophageal Squamous Cell Carcinoma. Planned enrolment is 490 participants (estimated). The study started in 2024-02-05 and primary completion is expected in 2026-12-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06194734","url":"https://clinicaltrials.gov/study/NCT06194734"}],"tags":["ctgov-ingest"],"related":[],"cancers":["esophageal","oesophageal-squamous-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["kc1036"],"companies":["beijing-konruns-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06194734","phase":"3","setting":"A Randomized, Controlled, Open-label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of KC1036 Versus Investigator's Choice of Chemotherapy as Third-line Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma","sponsor":"Beijing Konruns Pharmaceutical","started":"2024-02-05","startedType":"actual","enrolled":490,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05265091","kind":"trial","name":"A Study of KL590586 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of KL590586 Capsule in advanced solid tumours, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of KL590586 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05265091 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 414 participants enrolled, started 2021-09-15 and due to reach its primary completion in 2026-12-31. Interventions recorded: KL590586 Capsule.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05265091","url":"https://clinicaltrials.gov/study/NCT05265091"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05265091","phase":"1/2","setting":"An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of KL590586 Capsules In Patients With Advanced Solid Tumors Carrying RET Fusion Or Mutant Genes","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2021-09-15","startedType":"actual","enrolled":414,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07609823","kind":"trial","name":"A Study of Lacutoclax (LP-108) in Patients With Relapsed/Refractory CLL/SLL","aka":[],"tldr":"A phase 2 trial of Lacutoclax in chronic lymphocytic leukaemia, run by Guangzhou Lupeng Pharmaceutical Company LTD., now recruiting.","summary":"A Study of Lacutoclax (LP-108) in Patients With Relapsed/Refractory CLL/SLL is a phase 2 interventional study registered as NCT07609823 by Guangzhou Lupeng Pharmaceutical Company LTD., with 75 participants planned, started 2026-07-14 and due to reach its primary completion in 2028-03-30. Interventions recorded: Lacutoclax.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07609823","url":"https://clinicaltrials.gov/study/NCT07609823"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["lupeng-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07609823","phase":"2","setting":"A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Lacutoclax (LP-108) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","sponsor":"Guangzhou Lupeng Pharmaceutical Company LTD.","started":"2026-07-14","startedType":"actual","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05388669","kind":"trial","name":"A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)","aka":["PALOMA-3"],"tldr":"A phase 3 trial of Lazertinib in non-small-cell lung cancer and small-cell lung cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT05388669 by Janssen Research & Development, LLC, with 418 participants enrolled, started 2022-08-05 and due to reach its primary completion in 2024-01-03. Interventions recorded: Lazertinib, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF), Amivantamab Intravenous. Conditions listed: Advanced or Metastatic Non-small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05388669","url":"https://clinicaltrials.gov/study/NCT05388669"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["lazertinib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05388669","phase":"3","setting":"A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy","sponsor":"Janssen Research & Development, LLC","started":"2022-08-05","startedType":"actual","yearReported":2026,"enrolled":418,"enrolledBasis":"registry","outcomes":[{"endpoint":"For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State","primary":true,"unit":"micrograms per milliliters (mcg/ml)","arms":[{"name":"Arm A: Lazertinib With Amivantamab SC-CF","n":98,"value":206,"note":"geometric CV 39.1%; Figures from the ClinicalTrials.gov results section (first posted 2026-02-02), not from a publication"},{"name":"Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion","n":98,"value":144,"note":"geometric CV 41.5%"}],"source":"https://clinicaltrials.gov/study/NCT05388669?tab=results"}]},{"id":"nct07042802","kind":"trial","name":"A Study of LBL-024 in Combination With Paclitaxel ± Bevacizumab for the Treatment of Platinum-resistant Ovarian Cancer","aka":[],"tldr":"A phase 1/2 trial of Paclitaxel / nab-paclitaxel, Bevacizumab in ovarian cancer, run by Nanjing Leads Biolabs Co.,Ltd, now recruiting.","summary":"A Study of LBL-024 in Combination With Paclitaxel ± Bevacizumab for the Treatment of Platinum-resistant Ovarian Cancer is a phase 1/2 interventional study registered as NCT07042802 by Nanjing Leads Biolabs Co.,Ltd, with 180 participants planned, started 2025-12-02 and due to reach its primary completion in 2027-12-25. Interventions recorded: LBL-024 for Injection, Paclitaxel injection, Bevacizumab injection. Conditions listed: Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07042802","url":"https://clinicaltrials.gov/study/NCT07042802"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["paclitaxel","bevacizumab"],"companies":["nanjing-leads-biolabs"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07042802","phase":"1/2","setting":"An Open-label, Multi-center Phase Ib/II Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Paclitaxel Injection ± Bevacizumab in Patients With Platinum-resistant Ovarian Cancer","sponsor":"Nanjing Leads Biolabs Co.,Ltd","started":"2025-12-02","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07752875","kind":"trial","name":"A Study of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by LG Chem, not yet recruiting.","summary":"A Study of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation is a phase 1/2, interventional study registered as NCT07752875 by LG Chem, with a registry enrolment figure of 250 participants, started 2026-12-01 and due to reach its primary completion in 2032-10-31. Interventions recorded: LG00313112. Conditions listed: Ovarian Cancer; Small Cell Lung Cancer; Non Small Cell Lung Cancer; Colorectal Cancer; Esophageal Cancer; Breast Cancer; Endometrial Cancer; Head and Neck Cancer; Pancreatic Cancer; Locally Advanced Unresectable or Metastatic Solid Tumor. Primary outcome: Phase 1: Number of participants with dose-limiting toxicities (DLTs); Phase 1: Frequency of treatment-emergent adverse events (TEAEs); Phase 1: Frequency of serious adverse events (SAEs). Pancreatic eligibility wording from the registry: \"Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07752875","url":"https://clinicaltrials.gov/study/NCT07752875"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07752875","phase":"1/2","setting":"A Phase 1/2, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation","sponsor":"LG Chem","started":"2026-12-01","startedType":"estimated","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06481592","kind":"trial","name":"A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.","aka":[],"tldr":"A phase 2 trial of Lifileucel in endometrial cancer, run by Iovance Biotherapeutics, Inc., now recruiting.","summary":"A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer. is a phase 2 interventional study registered as NCT06481592 by Iovance Biotherapeutics, Inc., with 60 participants planned, started 2024-10-29 and due to reach its primary completion in 2028-05. Interventions recorded: Lifileucel. Conditions listed: Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06481592","url":"https://clinicaltrials.gov/study/NCT06481592"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":["til-therapy"],"targets":[],"drugs":["lifileucel"],"companies":["iovance"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06481592","phase":"2","setting":"A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Endometrial Cancer.","sponsor":"Iovance Biotherapeutics, Inc.","started":"2024-10-29","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07288203","kind":"trial","name":"A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma","aka":[],"tldr":"A phase 2 trial of Lifileucel in melanoma and skin cancer, run by Iovance Biotherapeutics, Inc., active and no longer recruiting.","summary":"A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma is a phase 2 interventional study registered as NCT07288203 by Iovance Biotherapeutics, Inc., with 100 participants planned, started 2025-11-28 and due to reach its primary completion in 2032-12. Interventions recorded: Lifileucel. Conditions listed: Melanoma (Skin Cancer), Unresectable Melanoma, Metastatic Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07288203","url":"https://clinicaltrials.gov/study/NCT07288203"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","skin-cancer","advanced-melanoma"],"sections":[],"technologies":["til-therapy"],"targets":[],"drugs":["lifileucel"],"companies":["iovance"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07288203","phase":"2","setting":"A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Melanoma","sponsor":"Iovance Biotherapeutics, Inc.","started":"2025-11-28","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07359820","kind":"trial","name":"A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement","aka":["ReFocus202"],"tldr":"A phase 2 trial of Lirafugratinib in advanced solid tumours, run by Elevar Therapeutics, now recruiting.","summary":"A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement is a phase 2 interventional study registered as NCT07359820 by Elevar Therapeutics, with 30 participants planned, started 2026-06-04 and due to reach its primary completion in 2027-09. Interventions recorded: Lirafugratinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07359820","url":"https://clinicaltrials.gov/study/NCT07359820"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["lirafugratinib"],"companies":["elevar-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07359820","phase":"2","setting":"A Phase 2, Open-Label, Single-Arm Study of Lirafugratinib in Patients With Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement","sponsor":"Elevar Therapeutics","started":"2026-06-04","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05518045","kind":"trial","name":"A Study of LM-108 as Monotherapy or in Combination With Antitumor Therapies in Subjects With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of LM-108 and Toripalimab in advanced solid tumours, run by LaNova Medicines Limited, active and no longer recruiting.","summary":"A Study of LM-108 as Monotherapy or in Combination With Antitumor Therapies in Subjects With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05518045 by LaNova Medicines Limited, with 392 participants enrolled, started 2022-08-26 and due to reach its primary completion in 2026-10-31. Interventions recorded: LM-108 and Toripalimab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05518045","url":"https://clinicaltrials.gov/study/NCT05518045"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["lm-108","toripalimab"],"companies":["lanova-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05518045","phase":"1/2","setting":"An Open-Label, Dose-Escalation and Dose-Expansion Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of LM-108 for Injection as Monotherapy or in Combination With Antitumor Therapies in Patients With Advanced Solid Tumors","sponsor":"LaNova Medicines Limited","started":"2022-08-26","startedType":"actual","enrolled":392,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06868199","kind":"trial","name":"A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours","aka":[],"tldr":"A phase 1/2 trial of Toripalimab in advanced solid tumours, run by LaNova Medicines Limited, now recruiting.","summary":"A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours is a phase 1/2 interventional study registered as NCT06868199 by LaNova Medicines Limited, with 87 participants planned, started 2025-05-06 and due to reach its primary completion in 2027-08-01. Interventions recorded: LM-168 and Toripalimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06868199","url":"https://clinicaltrials.gov/study/NCT06868199"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":["lanova-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06868199","phase":"1/2","setting":"A Phase I/II, First-in-Human (FIH), Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours","sponsor":"LaNova Medicines Limited","started":"2025-05-06","startedType":"actual","enrolled":87,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07669415","kind":"trial","name":"A Study of LM-168 Combined With Other Anti-tumor Treatments in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 2 trial of Tislelizumab and Docetaxel in advanced solid tumours, run by LaNova Medicines Limited, now recruiting.","summary":"A Study of LM-168 Combined With Other Anti-tumor Treatments in Participants With Advanced Solid Tumors is a phase 2 interventional study registered as NCT07669415 by LaNova Medicines Limited, with 108 participants planned, started 2026-07-29 and due to reach its primary completion in 2027-12-15. Interventions recorded: LM-168, Tislelizumab and Docetaxel injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07669415","url":"https://clinicaltrials.gov/study/NCT07669415"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tislelizumab","docetaxel"],"companies":["lanova-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07669415","phase":"2","setting":"A Phase II，Open Label,Multicenter Study to Evaluate the Efficacy,Safety,and Tolerability of LM-168 Combined With Other Anti-tumor Therapies in Participants With Advanced Solid Tumor Trials","sponsor":"LaNova Medicines Limited","started":"2026-07-29","startedType":"actual","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06187402","kind":"trial","name":"A Study of LM-24C5 For Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of LM-24C5 in advanced solid tumours, run by LaNova Medicines Limited, now recruiting.","summary":"A Study of LM-24C5 For Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06187402 by LaNova Medicines Limited, with 49 participants planned, started 2023-12-20 and due to reach its primary completion in 2026-06-30. Interventions recorded: LM-24C5.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06187402","url":"https://clinicaltrials.gov/study/NCT06187402"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["lanova-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06187402","phase":"1/2","setting":"A Phase I/II, First-in-Human (FIH), Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-24C5 in Patients With Advanced Solid Tumors","sponsor":"LaNova Medicines Limited","started":"2023-12-20","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07112222","kind":"trial","name":"A Study of LM-350 in Subjects With Advanced Solid Tumours","aka":[],"tldr":"A phase 1/2 trial of LM-350 for injection in advanced solid tumours, run by LaNova Medicines Limited, now recruiting.","summary":"A Study of LM-350 in Subjects With Advanced Solid Tumours is a phase 1/2 interventional study registered as NCT07112222 by LaNova Medicines Limited, with 80 participants planned, started 2025-08-28 and due to reach its primary completion in 2028-06-30. Interventions recorded: LM-350 for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07112222","url":"https://clinicaltrials.gov/study/NCT07112222"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["lanova-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07112222","phase":"1/2","setting":"A Phase I/II, First-in-Human (FIH), Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-350 in Patients With Advanced Solid Tumors","sponsor":"LaNova Medicines Limited","started":"2025-08-28","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06730347","kind":"trial","name":"A Study of Lorigerlimab in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 2 trial of Lorigerlimab in ovarian cancer and endometrial cancer, run by MacroGenics, now recruiting.","summary":"A Study of Lorigerlimab in Participants With Advanced Solid Tumors is a phase 2 interventional study registered as NCT06730347 by MacroGenics, with 80 participants planned, started 2025-05-01 and due to reach its primary completion in 2027-07. Interventions recorded: Lorigerlimab. Conditions listed: Platinum-resistant Ovarian Cancer, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Clear Cell Adenocarcinoma of Ovary. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06730347","url":"https://clinicaltrials.gov/study/NCT06730347"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","endometrial"],"sections":[],"technologies":[],"targets":[],"drugs":["lorigerlimab"],"companies":["macrogenics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06730347","phase":"2","setting":"A Phase 2 Multicohort Study to Evaluate Lorigerlimab in Participants With Advanced Solid Tumors","sponsor":"MacroGenics","started":"2025-05-01","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05297890","kind":"trial","name":"A Study of Lorlatinib in Subjects With ROS1-Positive Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Lorlatinib in non-small-cell lung cancer and small-cell lung cancer, run by CStone Pharmaceuticals, active and no longer recruiting.","summary":"A Study of Lorlatinib in Subjects With ROS1-Positive Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT05297890 by CStone Pharmaceuticals, with 70 participants enrolled, started 2022-05-27 and due to reach its primary completion in 2023-12-26. Interventions recorded: Lorlatinib. Conditions listed: Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05297890","url":"https://clinicaltrials.gov/study/NCT05297890"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","ros1-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["lorlatinib"],"companies":["cstone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05297890","phase":"2","setting":"A Phase 2, Multi-Center, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Lorlatinib Monotherapy in Crizotinib and Platinum-based Chemotherapy Treated Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer Subjects in China","sponsor":"CStone Pharmaceuticals","started":"2022-05-27","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01387763","kind":"trial","name":"A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms","aka":["DALIAH"],"tldr":"A phase 3 trial of Peginterferon alfa-2b and Hydroxyurea in Polycythaemia vera, Essential thrombocythaemia and Primary myelofibrosis, run by Thomas Stauffer Larsen, completed.","summary":"A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms is a phase 3 interventional study registered as NCT01387763 by Thomas Stauffer Larsen, with 202 participants recorded, started 2012-01 and reaching its primary completion in 2020-06. Interventions recorded: PegIntron, Pegasys, PegIntron, Pegasys, Hydrea. Conditions recorded: Polycythemia Vera, Essential Thrombocythemia, Primary Myelofibrosis.\n\nLinked to the drug Peginterferon alfa-2b because the registry names it among its interventions and Polycythaemia vera, Essential thrombocythaemia and Primary myelofibrosis among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01387763","url":"https://clinicaltrials.gov/study/NCT01387763"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["polycythaemia-vera","essential-thrombocythaemia","primary-myelofibrosis"],"sections":[],"technologies":[],"targets":[],"drugs":["peginterferon-alfa-2b","hydroxyurea"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01387763","phase":"3","setting":"Danish Study of Low-dose Interferon Alpha Versus Hydroxyurea in the Treatment of Philadelphia Chromosome Negative (Ph-)Chronic Myeloid Neoplasms.","sponsor":"Thomas Stauffer Larsen","started":"2012-01","enrolled":202,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05456256","kind":"trial","name":"A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma","aka":["HARMONIC"],"tldr":"A phase 2 trial of Pemetrexed and Carboplatin in non-small-cell lung cancer, run by Lantern Pharma Inc., now recruiting.","summary":"A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma is a phase 2 interventional study registered as NCT05456256 by Lantern Pharma Inc., with 90 participants planned, started 2023-03-01 and due to reach its primary completion in 2026-12. Interventions recorded: LP-300, Pemetrexed and Carboplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05456256","url":"https://clinicaltrials.gov/study/NCT05456256"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pemetrexed","carboplatin"],"companies":["lantern-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05456256","phase":"2","setting":"Phase II Trial of LP-300 in Combination With Carboplatin and Pemetrexed in Never Smoker Patients With Relapsed Advanced Primary Adenocarcinoma of the Lung After Treatment With Tyrosine Kinase Inhibitors (The HARMONIC Study)","sponsor":"Lantern Pharma Inc.","started":"2023-03-01","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07459634","kind":"trial","name":"A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC","aka":[],"tldr":"A phase 2 trial of Lurbinectedin, Durvalumab in small-cell lung cancer, run by Jazz Pharmaceuticals, now recruiting.","summary":"A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC is a phase 2 interventional study registered as NCT07459634 by Jazz Pharmaceuticals, with 50 participants planned, started 2026-11-30 and due to reach its primary completion in 2028-01-31. Interventions recorded: Lurbinectedin, Durvalumab. Conditions listed: Extensive-stage Small-cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07459634","url":"https://clinicaltrials.gov/study/NCT07459634"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["lurbinectedin","durvalumab"],"companies":["jazz"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07459634","phase":"2","setting":"A Phase 2, Multicenter, Open-Label, Single-Arm Study of Lurbinectedin in Combination With Durvalumab as First-line Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer Following Induction Treatment With Platinum Based Chemotherapy and Durvalumab","sponsor":"Jazz Pharmaceuticals","started":"2026-11-30","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06378177","kind":"trial","name":"A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC)","aka":[],"tldr":"A phase 2 trial of Toripalimab, Paclitaxel / nab-paclitaxel in head and neck squamous cell carcinoma, run by Lyvgen Biopharma Holdings Limited, active and no longer recruiting.","summary":"A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC) is a phase 2 interventional study registered as NCT06378177 by Lyvgen Biopharma Holdings Limited, with 64 participants planned, started 2024-06-21 and due to reach its primary completion in 2027-10-31. Interventions recorded: LVGN6051 Monoclonal Antibody Injection, toripalimab Injection, Paclitaxel injection. Conditions listed: Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06378177","url":"https://clinicaltrials.gov/study/NCT06378177"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab","paclitaxel","lvgn6051"],"companies":["lyvgen-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06378177","phase":"2","setting":"A Phase 2 Study of LVGN6051 Combined With Toripalimab and Paclitaxel for Recurrent/Metastatic HNSCC Rapidly Progressed From Previous Platinum-containing Curative Treatment or Contraindicated for Platinum-containing Treatment","sponsor":"Lyvgen Biopharma Holdings Limited","started":"2024-06-21","startedType":"actual","enrolled":64,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01594723","kind":"trial","name":"A Study of LY2784544 in Participants With Myeloproliferative Neoplasms","aka":[],"tldr":"A phase 2 trial of 120 mg LY2784544 in myeloproliferative neoplasms, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of LY2784544 in Participants With Myeloproliferative Neoplasms is a phase 2 interventional study registered as NCT01594723 by Eli Lilly and Company, with 110 participants enrolled, started 2012-05-22 and due to reach its primary completion in 2015-03-20. Interventions recorded: 120 mg LY2784544.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01594723","url":"https://clinicaltrials.gov/study/NCT01594723"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01594723","phase":"2","setting":"A Phase 2 Study of LY2784544 in Patients With Myeloproliferative Neoplasms","sponsor":"Eli Lilly and Company","started":"2012-05-22","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04274738","kind":"trial","name":"A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4","aka":[],"tldr":"A phase 1 trial of Mavorixafor and Ibrutinib in Waldenström macroglobulinaemia, run by X4 Pharmaceuticals, completed.","summary":"A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4 is a phase 1 interventional study registered as NCT04274738 by X4 Pharmaceuticals, with 16 participants recorded, started 2020-04-30 and reaching its primary completion in 2022-10-31. Interventions recorded: Mavorixafor, Ibrutinib. Conditions recorded: Waldenstrom's Macroglobulinemia.\n\nLinked to the drug Mavorixafor because the registry names it among its interventions and Waldenström macroglobulinaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04274738","url":"https://clinicaltrials.gov/study/NCT04274738"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["waldenstrom"],"sections":[],"technologies":[],"targets":[],"drugs":["mavorixafor","ibrutinib"],"companies":["x4-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04274738","phase":"1","setting":"A Phase 1b Trial of Mavorixafor, an Oral CXCR4 Antagonist, in Combination With Ibrutinib in Patients With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4","sponsor":"X4 Pharmaceuticals","started":"2020-04-30","startedType":"actual","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06232096","kind":"trial","name":"A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.","aka":[],"tldr":"A phase 1/2 trial of MBS314 Injection in multiple myeloma, run by Beijing Mabworks Biotech Co., Ltd., now recruiting.","summary":"A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma. is a phase 1/2 interventional study registered as NCT06232096 by Beijing Mabworks Biotech Co., Ltd., with 154 participants planned, started 2024-02-22 and due to reach its primary completion in 2026-02. Interventions recorded: MBS314 Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06232096","url":"https://clinicaltrials.gov/study/NCT06232096"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["beijing-mabworks-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06232096","phase":"1/2","setting":"A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS314 Injection in Patients With Relapsed/Refractory Multiple Myeloma.","sponsor":"Beijing Mabworks Biotech Co., Ltd.","started":"2024-02-22","startedType":"actual","enrolled":154,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02963493","kind":"trial","name":"A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 2 trial of Melphalan flufenamide and Dexamethasone in Multiple myeloma, run by Oncopeptides AB, completed.","summary":"A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT02963493 by Oncopeptides AB, with 157 participants recorded, started 2016-12-28 and reaching its primary completion in 2020-10-22. Interventions recorded: Melphalan flufenamide (Melflufen), Dexamethasone. Conditions recorded: Multiple Myeloma.\n\nLinked to the drug Melphalan flufenamide because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02963493","url":"https://clinicaltrials.gov/study/NCT02963493"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["melflufen","dexamethasone"],"companies":["oncopeptides"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02963493","phase":"2","setting":"A Single Arm, Open-Label, Phase 2 Study of Melflufen in Combination With Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Pomalidomide and/or an Anti-CD38 Monoclonal Antibody","sponsor":"Oncopeptides AB","started":"2016-12-28","startedType":"actual","yearReported":2022,"enrolled":157,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Response Rate (ORR)","primary":true,"unit":"participants","arms":[{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set","n":157,"value":53,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-02-01), not from a publication"},{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease","n":55,"value":14},{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease","n":119,"value":35}],"source":"https://clinicaltrials.gov/study/NCT02963493?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set","n":157,"value":11.79,"note":"95% CI 9.53 to 14.55; Figures from the ClinicalTrials.gov results section (first posted 2022-02-01), not from a publication"},{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease","n":55,"value":6.44,"note":"95% CI 5.06 to 9.66"},{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease","n":119,"value":10.12,"note":"95% CI 7.20 to 12.29"}],"source":"https://clinicaltrials.gov/study/NCT02963493?tab=results"},{"endpoint":"Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set","n":157,"value":4.27,"note":"95% CI 3.42 to 4.90; Figures from the ClinicalTrials.gov results section (first posted 2022-02-01), not from a publication"},{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease","n":55,"value":2.89,"note":"95% CI 1.97 to 3.94"},{"name":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease","n":119,"value":3.94,"note":"95% CI 3.09 to 4.67"}],"source":"https://clinicaltrials.gov/study/NCT02963493?tab=results"}]},{"id":"nct03151811","kind":"trial","name":"A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide","aka":[],"tldr":"A phase 3 trial of Melphalan flufenamide, Pomalidomide and Dexamethasone in Multiple myeloma, run by Oncopeptides AB, recorded as terminated on the registry.","summary":"A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide is a phase 3 interventional study registered as NCT03151811 by Oncopeptides AB, with 495 participants recorded, started 2017-06-12 and due to reach its primary completion in 2021-02-03. Interventions recorded: Melflufen, Pomalidomide, Dexamethasone. Conditions recorded: Multiple Myeloma.\n\nLinked to the drug Melphalan flufenamide because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03151811","url":"https://clinicaltrials.gov/study/NCT03151811"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["melflufen","pomalidomide","dexamethasone"],"companies":["oncopeptides"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03151811","phase":"3","setting":"A Randomized, Controlled, Open-label, Phase 3 Study of Melflufen/Dexamethasone Compared With Pomalidomide/Dexamethasone for Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Lenalidomide","sponsor":"Oncopeptides AB","started":"2017-06-12","startedType":"actual","yearReported":2022,"enrolled":495,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Arm A: Melflufen+Dexamethasone","n":246,"value":6.83,"note":"95% CI 4.96 to 8.54; Figures from the ClinicalTrials.gov results section (first posted 2022-07-27), not from a publication"},{"name":"Arm B: Pomalidomide+Dexamethasone","n":249,"value":4.93,"note":"95% CI 4.24 to 5.72"}],"p":"0.0311","source":"https://clinicaltrials.gov/study/NCT03151811?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Arm A: Melflufen+Dexamethasone","n":246,"value":20.24,"note":"95% CI 15.84 to 24.15; Figures from the ClinicalTrials.gov results section (first posted 2022-07-27), not from a publication"},{"name":"Arm B: Pomalidomide+Dexamethasone","n":249,"value":23.98,"note":"95% CI 18.92 to 27.86"}],"source":"https://clinicaltrials.gov/study/NCT03151811?tab=results"},{"endpoint":"Overall Response Rate (ORR)","unit":"participants","arms":[{"name":"Arm A: Melflufen+Dexamethasone","n":246,"value":80,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-07-27), not from a publication"},{"name":"Arm B: Pomalidomide+Dexamethasone","n":249,"value":67}],"source":"https://clinicaltrials.gov/study/NCT03151811?tab=results"}]},{"id":"nct06679829","kind":"trial","name":"A Study of Melphalan With or Without Siltuximab in People With Multiple Myeloma Having an Autologous Stem Cell Transplant","aka":[],"tldr":"A phase 2 trial of Siltuximab and Melphalan in Multiple myeloma, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"A Study of Melphalan With or Without Siltuximab in People With Multiple Myeloma Having an Autologous Stem Cell Transplant is a phase 2 interventional study registered as NCT06679829 by Memorial Sloan Kettering Cancer Center, with 215 participants planned, started 2024-11-06 and due to reach its primary completion in 2027-11. Interventions recorded: Siltuximab, Melphalan. Conditions recorded: Multiple Myeloma.\n\nLinked to the drug Siltuximab because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06679829","url":"https://clinicaltrials.gov/study/NCT06679829"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["siltuximab","melphalan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06679829","phase":"2","setting":"Phase II Randomized Trial of Population PK Dosed Melphalan With Interleukin-6 Blockade With Siltuximab Vesrus BSA Based Melphalan in Patients With Multiple Myeloma Over Age 60 Undergoing Autologous Stem Cell Transplantation","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2024-11-06","startedType":"actual","enrolled":215,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06952803","kind":"trial","name":"A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation","aka":["EvoPAR-Prostate02"],"tldr":"A phase 3 trial testing Saruparib in prostate cancer, now recruiting.","summary":"A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation is a phase 3 interventional study registered as NCT06952803, led by AstraZeneca with Parexel, and recruiting on the registry. Official title: A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy (EvoPAR-Prostate02). Planned enrolment is 700 participants (estimated). The study started in 2025-08-06 and primary completion is expected in 2033-03-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06952803","url":"https://clinicaltrials.gov/study/NCT06952803"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["saruparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06952803","phase":"3","setting":"A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy (EvoPAR-Prostate02)","sponsor":"AstraZeneca","started":"2025-08-06","startedType":"actual","enrolled":700,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07326488","kind":"trial","name":"A Study of MHB009C in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of MHB009C for Injection in advanced solid tumours, run by Minghui Pharmaceutical (Hangzhou) Ltd, now recruiting.","summary":"A Study of MHB009C in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07326488 by Minghui Pharmaceutical (Hangzhou) Ltd, with 200 participants planned, started 2026-03-17 and due to reach its primary completion in 2028-02. Interventions recorded: MHB009C for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07326488","url":"https://clinicaltrials.gov/study/NCT07326488"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["minghui-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07326488","phase":"1/2","setting":"A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB009C for Injection in Patients With Advanced Solid Tumors","sponsor":"Minghui Pharmaceutical (Hangzhou) Ltd","started":"2026-03-17","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07229599","kind":"trial","name":"A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of Furmonertinib and Carboplatin in advanced solid tumours, run by Minghui Pharmaceutical (Hangzhou) Ltd, now recruiting.","summary":"A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer is a phase 1/2 interventional study registered as NCT07229599 by Minghui Pharmaceutical (Hangzhou) Ltd, with 300 participants planned, started 2025-05-09 and due to reach its primary completion in 2029-05. Interventions recorded: MHB036C for Injection, MHB039A for Injection, Furmonertinib and Carboplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07229599","url":"https://clinicaltrials.gov/study/NCT07229599"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["furmonertinib","carboplatin","mhb039a","mhb036c"],"companies":["minghui-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07229599","phase":"1/2","setting":"A Phase I/II Clinical Study to Evaluate the Efficacy and Safety of MHB036C for Injection Combined With Other Anti-tumor Therapy in Patients With Advanced Lung Cancer","sponsor":"Minghui Pharmaceutical (Hangzhou) Ltd","started":"2025-05-09","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07130383","kind":"trial","name":"A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors","aka":[],"tldr":"A phase 2 trial of MHB036C for Injection in advanced solid tumours, run by Minghui Pharmaceutical (Hangzhou) Ltd, now recruiting.","summary":"A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors is a phase 2 interventional study registered as NCT07130383 by Minghui Pharmaceutical (Hangzhou) Ltd, with 210 participants planned, started 2025-09-30 and due to reach its primary completion in 2029-08. Interventions recorded: MHB036C for Injection and MHB039A for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07130383","url":"https://clinicaltrials.gov/study/NCT07130383"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["mhb039a","mhb036c"],"companies":["minghui-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07130383","phase":"2","setting":"An Open-label Phase II Clinical Study of MHB036C for Injection Combined With MHB039A for Injection in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors","sponsor":"Minghui Pharmaceutical (Hangzhou) Ltd","started":"2025-09-30","startedType":"actual","enrolled":210,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06373406","kind":"trial","name":"A Study of MHB036C for Advanced Solid Tumor","aka":[],"tldr":"A phase 1/2 trial of MHB036C in advanced solid tumours, run by Minghui Pharmaceutical (Hangzhou) Ltd, active and no longer recruiting.","summary":"A Study of MHB036C for Advanced Solid Tumor is a phase 1/2 interventional study registered as NCT06373406 by Minghui Pharmaceutical (Hangzhou) Ltd, with 200 participants enrolled, started 2023-05-26 and due to reach its primary completion in 2025-12. Interventions recorded: MHB036C.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06373406","url":"https://clinicaltrials.gov/study/NCT06373406"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["mhb036c"],"companies":["minghui-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06373406","phase":"1/2","setting":"A Phase I/II, Dose Escalation and Dose Expansion Study of MHB036C for Advanced Solid Tumor to Evaluate the Tolerability/Safety, Pharmacokinetics and Efficacy","sponsor":"Minghui Pharmaceutical (Hangzhou) Ltd","started":"2023-05-26","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06345482","kind":"trial","name":"A Study of MHB039A for Advanced Solid Tumor","aka":[],"tldr":"A phase 1/2 trial of MHB039A in advanced solid tumours, run by Minghui Pharmaceutical (Hangzhou) Ltd, active and no longer recruiting.","summary":"A Study of MHB039A for Advanced Solid Tumor is a phase 1/2 interventional study registered as NCT06345482 by Minghui Pharmaceutical (Hangzhou) Ltd, with 196 participants enrolled, started 2024-04-16 and due to reach its primary completion in 2028-04-01. Interventions recorded: MHB039A.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06345482","url":"https://clinicaltrials.gov/study/NCT06345482"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["mhb039a"],"companies":["minghui-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06345482","phase":"1/2","setting":"A Phase I/II Study of MHB039A for Advanced Solid Tumor to Evaluate the Efficacy and Safety","sponsor":"Minghui Pharmaceutical (Hangzhou) Ltd","started":"2024-04-16","startedType":"actual","enrolled":196,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07192107","kind":"trial","name":"A Study of MHB042C in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of MHB042C for Injection in advanced solid tumours, run by Minghui Pharmaceutical (Hangzhou) Ltd, now recruiting.","summary":"A Study of MHB042C in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07192107 by Minghui Pharmaceutical (Hangzhou) Ltd, with 200 participants planned, started 2025-11-27 and due to reach its primary completion in 2029-10. Interventions recorded: MHB042C for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07192107","url":"https://clinicaltrials.gov/study/NCT07192107"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["minghui-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07192107","phase":"1/2","setting":"A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB042C for Injection in Patients With Advanced Solid Tumors","sponsor":"Minghui Pharmaceutical (Hangzhou) Ltd","started":"2025-11-27","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06985355","kind":"trial","name":"A Study of MHB046C Injection in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of MHB046C in advanced solid tumours, run by Minghui Pharmaceutical (Hangzhou) Ltd, now recruiting.","summary":"A Study of MHB046C Injection in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06985355 by Minghui Pharmaceutical (Hangzhou) Ltd, with 200 participants planned, started 2025-07-17 and due to reach its primary completion in 2029-05. Interventions recorded: MHB046C.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06985355","url":"https://clinicaltrials.gov/study/NCT06985355"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["minghui-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06985355","phase":"1/2","setting":"A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB046C Injection in Patients With Advanced Solid Tumors","sponsor":"Minghui Pharmaceutical (Hangzhou) Ltd","started":"2025-07-17","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07192120","kind":"trial","name":"A Study of MHB048C in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of MHB048C for Injection in prostate cancer, run by Minghui Pharmaceutical (Hangzhou) Ltd, now recruiting.","summary":"A Study of MHB048C in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07192120 by Minghui Pharmaceutical (Hangzhou) Ltd, with 200 participants planned, started 2026-01-16 and due to reach its primary completion in 2029-10. Interventions recorded: MHB048C for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07192120","url":"https://clinicaltrials.gov/study/NCT07192120"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["minghui-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07192120","phase":"1/2","setting":"A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB048C for Injection in Patients With Advanced Solid Tumors","sponsor":"Minghui Pharmaceutical (Hangzhou) Ltd","started":"2026-01-16","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07126665","kind":"trial","name":"A Study of MHB088C Combined With MHB039A in Patients With Advanced Malignant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of QLC5508 in advanced solid tumours, run by Minghui Pharmaceutical (Hangzhou) Ltd, now recruiting.","summary":"A Study of MHB088C Combined With MHB039A in Patients With Advanced Malignant Solid Tumors is a phase 1/2 interventional study registered as NCT07126665 by Minghui Pharmaceutical (Hangzhou) Ltd, with 116 participants planned, started 2025-09-18 and due to reach its primary completion in 2029-08. Interventions recorded: MHB088C for Injection and MHB039A for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07126665","url":"https://clinicaltrials.gov/study/NCT07126665"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["qlc5508","mhb039a"],"companies":["minghui-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07126665","phase":"1/2","setting":"An Open-label Phase I/II Clinical Study of MHB088C for Injection Combined With MHB039A for Injection in Patients With Advanced Malignant Solid Tumors","sponsor":"Minghui Pharmaceutical (Hangzhou) Ltd","started":"2025-09-18","startedType":"actual","enrolled":116,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06954246","kind":"trial","name":"A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial testing QLC5508 in non-small-cell lung cancer, now recruiting.","summary":"A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06954246, led by Qilu Pharmaceutical, and recruiting on the registry. Official title: A Phase 3, Multicenter, Randomised, Open-label Study of MHB088C for Injection Versus Treatment of Physician's Choice (TPC) in Comparing the Efficacy and Safety in Subjects With Relapsed Small Cell Lung Cancer (SCLC). Planned enrolment is 450 participants (estimated). The study started in 2025-06-04 and primary completion is expected in 2027-05. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06954246","url":"https://clinicaltrials.gov/study/NCT06954246"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["qlc5508"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06954246","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Open-label Study of MHB088C for Injection Versus Treatment of Physician's Choice (TPC) in Comparing the Efficacy and Safety in Subjects With Relapsed Small Cell Lung Cancer (SCLC)","sponsor":"Qilu Pharmaceutical","started":"2025-06-04","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06979596","kind":"trial","name":"A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)","aka":["OMAHA-015"],"tldr":"A phase 2 trial of Opevesostat, Dexamethasone, Fulvestrant, Exemestane, Megestrol acetate and Tamoxifen in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) is a phase 2 interventional study registered as NCT06979596 by Merck Sharp & Dohme LLC, with 250 participants planned, started 2025-08-11 and due to reach its primary completion in 2027-11-04. Interventions recorded: Opevesostat, Fludrocortisone/ Fludrocortisone acetate, Dexamethasone/Dexamethasone acetate, Rescue Medications, Fulvestrant and Exemestane.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06979596","url":"https://clinicaltrials.gov/study/NCT06979596"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["opevesostat","dexamethasone","fulvestrant","exemestane","megestrol","tamoxifen"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06979596","phase":"2","setting":"A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-08-11","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06796907","kind":"trial","name":"A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2)","aka":["BEHOLD-2"],"tldr":"A phase 1/2 trial of Dostarlimab and Bevacizumab in advanced solid tumours, run by GlaxoSmithKline, now recruiting.","summary":"A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2) is a phase 1/2 interventional study registered as NCT06796907 by GlaxoSmithKline, with 305 participants planned, started 2025-03-04 and due to reach its primary completion in 2027-06-21. Interventions recorded: Mo-Rez, Dostarlimab and Bevacizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06796907","url":"https://clinicaltrials.gov/study/NCT06796907"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["dostarlimab","bevacizumab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06796907","phase":"1/2","setting":"A Phase 1/2 Randomized Multi-Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan in Combination With Anti-Cancer Agents in Participants With Advanced Solid Tumors","sponsor":"GlaxoSmithKline","started":"2025-03-04","startedType":"actual","enrolled":305,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07701486","kind":"trial","name":"A Study of More Frequent Dosing of VCN-01 Combined With Standard Chemotherapy in Patients With Newly Diagnosed Metastatic Pancreatic Cancer","aka":["VIRAGE2"],"tldr":"A phase 1/2 trial of Gemcitabine in pancreatic ductal adenocarcinoma, run by Theriva Biologics SL, now recruiting.","summary":"A Study of More Frequent Dosing of VCN-01 Combined With Standard Chemotherapy in Patients With Newly Diagnosed Metastatic Pancreatic Cancer is a phase 1/2 interventional study registered as NCT07701486 by Theriva Biologics SL, with 6 participants planned, started 2026-08-03 and due to reach its primary completion in 2027-08-01. Interventions recorded: VCN-01 oncolytic adenovirus (zabilugene almadenorepvec) and Nab-paclitaxel + Gemcitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07701486","url":"https://clinicaltrials.gov/study/NCT07701486"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07701486","phase":"1/2","setting":"A Phase IIa, Single-arm, Single-center, Open Label, Proof-of-concept Trial Evaluating Increased Frequency Dosing of VCN-01 (Zabilugene Almadenorepvec) in Combination With Nab-Paclitaxel/Gemcitabine (GnP) in Patients With Newly-Diagnosed Metastatic Pancreatic Cancer","sponsor":"Theriva Biologics SL","started":"2026-08-03","startedType":"estimated","enrolled":6,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07208149","kind":"trial","name":"A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)","aka":[],"tldr":"A phase 1/2 trial of MCLA-129 in triple-negative breast cancer, run by Shenzhen Majory Biotechnology Co., Ltd., now recruiting.","summary":"A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC) is a phase 1/2 interventional study registered as NCT07208149 by Shenzhen Majory Biotechnology Co., Ltd., with 42 participants planned, started 2026-01-29 and due to reach its primary completion in 2028-09-01. Interventions recorded: MR001 Bispecific Antibody for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07208149","url":"https://clinicaltrials.gov/study/NCT07208149"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["mcla-129"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07208149","phase":"1/2","setting":"A Phase Ib/IIa, Open-Label, Two-Cohort, Dose-Escalation and Dose-Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC) Who Have Progressed After First-Line or Later-Line Therapy","sponsor":"Shenzhen Majory Biotechnology Co., Ltd.","started":"2026-01-29","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04492488","kind":"trial","name":"A Study of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer","aka":[],"tldr":"A phase 1/2 trial of MRG002 in gastric & gastro-oesophageal junction cancer, run by Shanghai Miracogen Inc., active and no longer recruiting.","summary":"A Study of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer is a phase 1/2 interventional study registered as NCT04492488 by Shanghai Miracogen Inc., with 129 participants enrolled, started 2021-05-24 and due to reach its primary completion in 2022-10-18. Interventions recorded: MRG002.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04492488","url":"https://clinicaltrials.gov/study/NCT04492488"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["mrg002"],"companies":["shanghai-miracogen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04492488","phase":"1/2","setting":"An Open-Label, Multi-center Phase I/II Dose Escalation and Expansion Study to Assess the Safety, Efficacy and Pharmacokinetics of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer","sponsor":"Shanghai Miracogen Inc.","started":"2021-05-24","startedType":"actual","enrolled":129,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05754853","kind":"trial","name":"A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer","aka":[],"tldr":"A phase 3 trial testing MRG002 in bladder & urothelial cancer, now recruiting.","summary":"A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer is a phase 3 interventional study registered as NCT05754853, led by Shanghai Miracogen, and recruiting on the registry. Official title: An Open-label, Randomised, Multi-centre, Phase III Clinical Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Urothelial Cancer Previously Treated With Platinum-based Chemotherapy and PD-1/PD-L1 Inhibitors. Planned enrolment is 290 participants (estimated). The study started in 2023-04-06 and primary completion is expected in 2025-10. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05754853","url":"https://clinicaltrials.gov/study/NCT05754853"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["mrg002"],"companies":["shanghai-miracogen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05754853","phase":"3","setting":"An Open-label, Randomized, Multi-center, Phase III Clinical Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Urothelial Cancer Previously Treated With Platinum-based Chemotherapy and PD-1/PD-L1 Inhibitors","sponsor":"Shanghai Miracogen","started":"2023-04-06","startedType":"estimated","enrolled":290,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06976190","kind":"trial","name":"A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcin","aka":["Magic-C002"],"tldr":"A phase 3 trial of MRG003, Pucotenlimab, Gemcitabine in nasopharyngeal carcinoma, run by Lepu Biopharma Co., Ltd., now recruiting.","summary":"A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma is a phase 3 interventional study registered as NCT06976190 by Lepu Biopharma Co., Ltd., with 446 participants planned, started 2025-05-06 and due to reach its primary completion in 2029-05. Interventions recorded: MRG003 + Pucotenlimab, Gemcitabine, Docetaxel, or Capecitabine. Conditions listed: Recurrent or Metastatic Nasopharyngeal Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06976190","url":"https://clinicaltrials.gov/study/NCT06976190"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nasopharyngeal","recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["mrg003","pucotenlimab","gemcitabine","docetaxel"],"companies":["lepu-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06976190","phase":"3","setting":"A Randomized, Open-label, Multi-center, Phase III Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma","sponsor":"Lepu Biopharma Co., Ltd.","started":"2025-05-06","startedType":"actual","enrolled":446,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05688605","kind":"trial","name":"A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of MRG003+HX008 in advanced solid tumours, run by Lepu Biopharma Co., Ltd., now recruiting.","summary":"A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05688605 by Lepu Biopharma Co., Ltd., with 18 participants planned, started 2022-06-30 and due to reach its primary completion in 2027-08. Interventions recorded: MRG003+HX008.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05688605","url":"https://clinicaltrials.gov/study/NCT05688605"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["lepu-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05688605","phase":"1/2","setting":"An Open-label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MRG003 in Combination With HX008 in Patients With EGFR-positive Advanced Solid Tumors","sponsor":"Lepu Biopharma Co., Ltd.","started":"2022-06-30","startedType":"actual","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07093970","kind":"trial","name":"A Study of MRG006A in the Treatment of Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of MRG006A in advanced solid tumours, run by Lepu Biopharma Co., Ltd., now recruiting.","summary":"A Study of MRG006A in the Treatment of Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07093970 by Lepu Biopharma Co., Ltd., with 343 participants planned, started 2024-07-24 and due to reach its primary completion in 2027-12. Interventions recorded: MRG006A.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07093970","url":"https://clinicaltrials.gov/study/NCT07093970"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["lepu-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07093970","phase":"1/2","setting":"A Phase I/II, Open-label, Multi-center, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of MRG006A in Patients With Advanced Solid Tumors","sponsor":"Lepu Biopharma Co., Ltd.","started":"2024-07-24","startedType":"actual","enrolled":343,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07737600","kind":"trial","name":"A Study of MRG007 Combination Therapy for Advanced Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of fluorouracil (5-FU), leucovorin (folinic acid), bevacizumab (glioblastoma use), fOLFOX (5-FU, leucovorin, oxaliplatin) and other drugs in colorectal cancer, run by Lepu Biopharma Co., Ltd., not yet recruiting.","summary":"A Study of MRG007 Combination Therapy for Advanced Colorectal Cancer is a phase 1/2, interventional study registered as NCT07737600 by Lepu Biopharma Co., Ltd., with a registry enrolment figure of 316 participants, started 2026-08 and due to reach its primary completion in 2028-12. Interventions recorded: MRG007; 5-Fluorouracil / Leucovorin Calcium; Bevacizumab; Oxaliplatin; PD-1/VEGF antibody; Capecitabine. Conditions listed: Advanced Colorectal Cancer. Primary outcome: Dose Limiting Toxicity (DLT); Serious Adverse Events (SAEs); Adverse Event (AE). Colorectal eligibility wording from the registry: \"Pathologically confirmed, unresectable locally advanced or metastatic colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07737600","url":"https://clinicaltrials.gov/study/NCT07737600"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["fluorouracil","leucovorin","bevacizumab-glioma","folfox","capecitabine"],"companies":["lepu-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07737600","phase":"1/2","setting":"Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of MRG007 Combination Therapy in Patients With Advanced Colorectal Cancer","sponsor":"Lepu Biopharma Co., Ltd.","started":"2026-08","startedType":"estimated","enrolled":316,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07116616","kind":"trial","name":"A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 1/2 trial of mRNA-2808 in multiple myeloma, run by ModernaTX, Inc., now recruiting.","summary":"A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT07116616 by ModernaTX, Inc., with 166 participants planned, started 2025-09-30 and due to reach its primary completion in 2030-06-17. Interventions recorded: mRNA-2808.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07116616","url":"https://clinicaltrials.gov/study/NCT07116616"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["moderna"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07116616","phase":"1/2","setting":"A Phase 1/2, Open-label, Multicenter Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma","sponsor":"ModernaTX, Inc.","started":"2025-09-30","startedType":"actual","enrolled":166,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05658562","kind":"trial","name":"A Study of MT-2111 in Patients With Relapsed/Refractory DLBCL","aka":[],"tldr":"A phase 1/2 trial of Loncastuximab tesirine in diffuse large b-cell lymphoma, run by Tanabe Pharma Corporation, active and no longer recruiting.","summary":"A Study of MT-2111 in Patients With Relapsed/Refractory DLBCL is a phase 1/2 interventional study registered as NCT05658562 by Tanabe Pharma Corporation, with 46 participants enrolled, started 2023-01-30 and due to reach its primary completion in 2028-08. Interventions recorded: MT-2111. Conditions listed: Diffuse Large B-Cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05658562","url":"https://clinicaltrials.gov/study/NCT05658562"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["zynlonta"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05658562","phase":"1/2","setting":"A Phase I/II Open-Label Study of MT-2111 in Patients With Relapsed/Refractory DLBCL","sponsor":"Tanabe Pharma Corporation","started":"2023-01-30","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06943521","kind":"trial","name":"A Study of MT-4561 in Patients With Various Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of MT-4561 in head and neck squamous cell carcinoma, non-small-cell lung cancer, oesophageal cancer, gastric & gastro-oesophageal junction cancer, biliary tract cancer and pancreatic ductal adenocarcinoma, run by Tanabe Pharma America, Inc., now recruiting.","summary":"A Study of MT-4561 in Patients With Various Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06943521 by Tanabe Pharma America, Inc., with 27 participants planned, started 2025-04-18 and due to reach its primary completion in 2028-08. Interventions recorded: MT-4561.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06943521","url":"https://clinicaltrials.gov/study/NCT06943521"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","nsclc","esophageal","gastric","cholangiocarcinoma","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06943521","phase":"1/2","setting":"A Phase I/II, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam","sponsor":"Tanabe Pharma America, Inc.","started":"2025-04-18","startedType":"actual","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04302025","kind":"trial","name":"A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)","aka":["NAUTIKA1"],"tldr":"A phase 2 trial of Alectinib, Entrectinib, Vemurafenib in non-small-cell lung cancer and small-cell lung cancer, run by Genentech, Inc., now recruiting.","summary":"A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC) is a phase 2 interventional study registered as NCT04302025 by Genentech, Inc., with 99 participants planned, started 2020-11-06 and due to reach its primary completion in 2026-11-30. Interventions recorded: Alectinib, Entrectinib, Vemurafenib, Cobimetinib, Pralsetinib. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04302025","url":"https://clinicaltrials.gov/study/NCT04302025"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["alectinib","entrectinib","vemurafenib","cobimetinib","pralsetinib","atezolizumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04302025","phase":"2","setting":"NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer","sponsor":"Genentech, Inc.","started":"2020-11-06","startedType":"actual","enrolled":99,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03862430","kind":"trial","name":"A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM","aka":["RESTORE"],"tldr":"A phase 2 trial of NanO2TM in glioma & glioblastoma, run by NuvOx LLC, active and no longer recruiting.","summary":"A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM is a phase 2 interventional study registered as NCT03862430 by NuvOx LLC, with 87 participants enrolled, started 2023-03-31 and due to reach its primary completion in 2027-06-30. Interventions recorded: NanO2TM and Placebo Saline Infusion.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03862430","url":"https://clinicaltrials.gov/study/NCT03862430"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03862430","phase":"2","setting":"A Phase II Double-blind, RandomizEd, Prospective, Placebo Controlled STudy of NanO2TM Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma multiformE: RESTORE","sponsor":"NuvOx LLC","started":"2023-03-31","startedType":"actual","enrolled":87,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07026279","kind":"trial","name":"A Study of Narmafotinib Given in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of narmafotinib ascending doses in pancreatic ductal adenocarcinoma, run by Amplia Therapeutics Limited, active and no longer recruiting.","summary":"A Study of Narmafotinib Given in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer is a phase 1/2 interventional study registered as NCT07026279 by Amplia Therapeutics Limited, with 67 participants enrolled, started 2025-08-18 and due to reach its primary completion in 2029-07. Interventions recorded: narmafotinib ascending doses and narmafotinib dose comparison.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07026279","url":"https://clinicaltrials.gov/study/NCT07026279"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["amplia-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07026279","phase":"1/2","setting":"A Phase 1b/2a, Multicenter, Open Label Study of the Safety, Efficacy and Pharmacokinetics of Narmafotinib in Combination With Modified FOLFIRINOX in Pancreatic Cancer Patients","sponsor":"Amplia Therapeutics Limited","started":"2025-08-18","startedType":"actual","enrolled":67,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06855771","kind":"trial","name":"A Study of Navlimetostat (BMS-986504) in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)","aka":["MountainTAP-9"],"tldr":"A phase 2 trial of BMS-986504 in non-small-cell lung cancer, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study of Navlimetostat (BMS-986504) in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9) is a phase 2 interventional study registered as NCT06855771 by Bristol-Myers Squibb, with 130 participants planned, started 2025-09-09 and due to reach its primary completion in 2028-12-29. Interventions recorded: BMS-986504.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06855771","url":"https://clinicaltrials.gov/study/NCT06855771"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06855771","phase":"2","setting":"A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of Navlimetostat (BMS-986504) Monotherapy in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion After Progression on Prior Therapies","sponsor":"Bristol-Myers Squibb","started":"2025-09-09","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05128487","kind":"trial","name":"A Study of NDI 1150-101 in Patients With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in renal cell carcinoma and non-small-cell lung cancer, run by Nimbus Saturn, Inc., active and no longer recruiting.","summary":"A Study of NDI 1150-101 in Patients With Solid Tumors is a phase 1/2 interventional study registered as NCT05128487 by Nimbus Saturn, Inc., with 106 participants planned, started 2021-11-05 and due to reach its primary completion in 2025-02. Interventions recorded: NDI-101150, Pembrolizumab. Conditions listed: Solid Tumor, Renal Cell Carcinoma (Kidney Cancer), Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05128487","url":"https://clinicaltrials.gov/study/NCT05128487"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc","nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["nimbus-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05128487-cell-rep-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05128487","phase":"1/2","setting":"A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of NDI-101150 Administered as Monotherapy or in Combination With Pembrolizumab in Patients With Solid Tumors","sponsor":"Nimbus Saturn, Inc.","started":"2021-11-05","startedType":"actual","enrolled":106,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03162536","kind":"trial","name":"A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-1026-001)","aka":[],"tldr":"A phase 1/2 trial of Nemtabrutinib in mantle cell lymphoma and diffuse large b-cell lymphoma, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA), active and no longer recruiting.","summary":"A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-1026-001) is a phase 1/2 interventional study registered as NCT03162536 by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA), with 190 participants planned, started 2017-06-26 and due to reach its primary completion in 2027-09-17. Interventions recorded: Nemtabrutinib. Conditions listed: Lymphoma, B-Cell, Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom Macroglobulinemia. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03162536","url":"https://clinicaltrials.gov/study/NCT03162536"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma","dlbcl","follicular-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["nemtabrutinib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03162536","phase":"1/2","setting":"A Phase 1/2 Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of ARQ 531 in Selected Subjects With Relapsed or Refractory Hematologic Malignancies","sponsor":"ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)","started":"2017-06-26","startedType":"actual","enrolled":190,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05947851","kind":"trial","name":"A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).","aka":["BELLWAVE-010"],"tldr":"A phase 3 trial of Nemtabrutinib, Venetoclax and Rituximab in chronic lymphocytic leukaemia and non-Hodgkin lymphoma, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010). is a phase 3 interventional study registered as NCT05947851 by Merck Sharp & Dohme LLC, with 735 participants planned, started 2023-08-08 and due to reach its primary completion in 2032-06-01. Interventions recorded: Nemtabrutinib, Venetoclax and Rituximab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05947851","url":"https://clinicaltrials.gov/study/NCT05947851"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","non-hodgkin-lymphoma","cll-relapsed"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["nemtabrutinib","venetoclax","rituximab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05947851","phase":"3","setting":"A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib (MK-1026) Plus Venetoclax Versus Venetoclax Plus Rituximab in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Following at Least 1 Prior Therapy (BELLWAVE-010)","sponsor":"Merck Sharp & Dohme LLC","started":"2023-08-08","startedType":"actual","enrolled":735,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05624554","kind":"trial","name":"A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)","aka":["BELLWAVE-008"],"tldr":"A phase 3 trial of Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine and Rituximab in chronic lymphocytic leukaemia, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008) is a phase 3 interventional study registered as NCT05624554 by Merck Sharp & Dohme LLC, with 300 participants enrolled, started 2023-03-16 and due to reach its primary completion in 2027-05-19. Interventions recorded: Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab and Truxima.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05624554","url":"https://clinicaltrials.gov/study/NCT05624554"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["nemtabrutinib","fludarabine","cyclophosphamide","bendamustine","rituximab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05624554","phase":"3","setting":"A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Chemoimmunotherapy for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Without TP53 Aberrations","sponsor":"Merck Sharp & Dohme LLC","started":"2023-03-16","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07586202","kind":"trial","name":"A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC","aka":["AmiNA"],"tldr":"A phase 2 trial of Amivantamab, Lazertinib, Carboplatin and Pemetrexed in non-small-cell lung cancer, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC is a phase 2 interventional study registered as NCT07586202 by Janssen Research & Development, LLC, with 68 participants planned, started 2026-07-28 and due to reach its primary completion in 2028-03-02. Interventions recorded: Amivantamab, Lazertinib, Carboplatin and Pemetrexed.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07586202","url":"https://clinicaltrials.gov/study/NCT07586202"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["bispecific-antibody","kinase-inhibitors"],"targets":[],"drugs":["amivantamab","lazertinib","carboplatin","pemetrexed"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07586202","phase":"2","setting":"A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer","sponsor":"Janssen Research & Development, LLC","started":"2026-07-28","startedType":"actual","enrolled":68,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04025879","kind":"trial","name":"A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer","aka":["CheckMate 77T"],"tldr":"A phase 3 trial of Nivolumab, Carboplatin, Cisplatin, Pemetrexed and Docetaxel in non-small-cell lung cancer, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT04025879 by Bristol-Myers Squibb, with 461 participants enrolled, started 2019-11-05 and due to reach its primary completion in 2023-07-26. Interventions recorded: Nivolumab, Carboplatin, Cisplatin, Paclitaxel, Pemetrexed and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04025879","url":"https://clinicaltrials.gov/study/NCT04025879"},{"label":"CheckMate 77T (New England Journal of Medicine 2024)","url":"https://doi.org/10.1056/NEJMoa2311926"},{"label":"NICE TA1127: nivolumab with chemotherapy neoadjuvant then alone adjuvant for resectable non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1127"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","carboplatin","cisplatin","pemetrexed","docetaxel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":["checkmate-816","keynote-671","nct03800134","neotorch","nct04379635"],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04025879-n-engl-j-med-2024"],"journals":[],"dependsOn":[],"notes":["CheckMate 77T was a phase 3 double-blind trial in adults with resectable stage IIA to IIIB non-small-cell lung cancer, randomised to four cycles of neoadjuvant nivolumab with chemotherapy or chemotherapy with placebo every three weeks, then surgery and up to thirteen cycles of adjuvant nivolumab or placebo every four weeks. At the prespecified interim analysis (median follow-up 25.4 months) the 18-month event-free survival rate was 70.2 percent against 50.0 percent (hazard ratio for progression, recurrence, abandoned surgery or death 0.58, 97.36 percent confidence interval 0.42 to 0.81). In the 68 Japanese patients, median event-free survival was not reached against 12.1 months (hazard ratio 0.46, 0.22 to 0.95), with pathological complete response 42.5 against 0 percent and major pathological response 52.5 against 7.1 percent (New England Journal of Medicine 2024; Cancer Science 2026)."],"nct":"NCT04025879","phase":"3","setting":"A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer","sponsor":"Bristol-Myers Squibb","result":"Eighteen-month event-free survival 70.2 percent with perioperative nivolumab against 50.0 percent with chemotherapy alone (hazard ratio 0.58, 97.36 percent confidence interval 0.42 to 0.81).","started":"2019-11-05","startedType":"actual","yearReported":2024,"enrolled":461,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-Free Survival (EFS) by BICR","primary":true,"unit":"months","arms":[{"name":"Nivolumab + SOC Chemotherapy","n":229,"note":"Insufficient number of participants with events; Figures from the ClinicalTrials.gov results section (first posted 2024-07-23), not from a publication"},{"name":"Placebo + SOC Chemotherapy","n":232,"value":18.43,"note":"95% CI 13.63 to 28.06"}],"p":"0.00025","source":"https://clinicaltrials.gov/study/NCT04025879?tab=results"}],"replication":"AEGEAN, KEYNOTE-671, Neotorch and RATIONALE-315 all found the same direction of effect with the same perioperative design."},{"id":"nct06567782","kind":"trial","name":"A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer","aka":["AZUR-4"],"tldr":"A phase 2 trial of Dostarlimab in colorectal cancer, run by GlaxoSmithKline, now recruiting.","summary":"A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer is a phase 2 interventional study registered as NCT06567782 by GlaxoSmithKline, with 120 participants planned, started 2025-02-18 and due to reach its primary completion in 2026-11-23. Interventions recorded: Dostarlimab and CAPEOX.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06567782","url":"https://clinicaltrials.gov/study/NCT06567782"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06567782","phase":"2","setting":"A Phase 2, Open Label, Randomized Study of Neoadjuvant Dostarlimab Plus CAPEOX Versus CAPEOX in Participants With Previously Untreated T4N0 or Stage III MMRp/ MSS Colon Cancer","sponsor":"GlaxoSmithKline","started":"2025-02-18","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06686576","kind":"trial","name":"A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer","aka":[],"tldr":"A phase 3 trial testing QL1706 in colorectal cancer, now recruiting.","summary":"A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer is a phase 3 interventional study registered as NCT06686576, led by Qilu Pharmaceutical, and recruiting on the registry. Official title: A Phase Ib/III, Open-Label, Randomised Study of Neoadjuvant QL1706 Versus Standard of Care in Participants With Untreated of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer. Planned enrolment is 363 participants (estimated). The study started in 2024-12-12 and primary completion is expected in 2030-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06686576","url":"https://clinicaltrials.gov/study/NCT06686576"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["ql1706"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06686576","phase":"3","setting":"A Phase Ib/III, Open-Label, Randomized Study of Neoadjuvant QL1706 Versus Standard of Care in Participants With Untreated of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer","sponsor":"Qilu Pharmaceutical","started":"2024-12-12","startedType":"actual","enrolled":363,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05751928","kind":"trial","name":"A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma","aka":[],"tldr":"A phase 3 trial testing BCD-217 in melanoma, active and no longer recruiting.","summary":"A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma is a phase 3 interventional study registered as NCT05751928, led by Biocad, and active but no longer recruiting on the registry. Official title: A Randomised Study of the Efficacy and Safety of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) Versus Standard Adjuvant Therapy With Pembrolizumab in Patients With Resectable Stage III Skin Melanoma. Planned enrolment is 411 participants (actual). The study started in 2023-04-05 and primary completion is expected in 2027-01. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05751928","url":"https://clinicaltrials.gov/study/NCT05751928"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","stage-iii-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["bcd-217"],"companies":["biocad"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05751928","phase":"3","setting":"A Randomized Study of the Efficacy and Safety of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) Versus Standard Adjuvant Therapy With Pembrolizumab in Patients With Resectable Stage III Skin Melanoma","sponsor":"Biocad","started":"2023-04-05","startedType":"actual","enrolled":411,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06198751","kind":"trial","name":"A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer","aka":[],"tldr":"A phase 2 trial of TQB2102 in HER2-positive breast cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., active and no longer recruiting.","summary":"A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer is a phase 2 interventional study registered as NCT06198751 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with 104 participants enrolled, started 2024-02-05 and due to reach its primary completion in 2025-05-08. Interventions recorded: 6.0 mg/kg of TQB2102 for injection and 7.5 mg/kg of TQB2102 for injection.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06198751","url":"https://clinicaltrials.gov/study/NCT06198751"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb2102"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct06198751-j-clin-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06198751","phase":"2","setting":"A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of TQB2102 for Injection for Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2024-02-05","startedType":"actual","enrolled":104,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03800134","kind":"trial","name":"A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer","aka":["AEGEAN"],"tldr":"A phase 3 trial of Durvalumab, Carboplatin, Cisplatin in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT03800134 by AstraZeneca, with 825 participants enrolled, started 2018-12-06 and due to reach its primary completion in 2022-11-10. Interventions recorded: Durvalumab, Placebo, Carboplatin, Cisplatin, Pemetrexed. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03800134","url":"https://clinicaltrials.gov/study/NCT03800134"},{"label":"AEGEAN updated outcomes (Journal of Clinical Oncology 2026)","url":"https://doi.org/10.1200/JCO-25-02659"},{"label":"NICE TA1030: durvalumab with chemotherapy before surgery then alone after surgery for resectable non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1030"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","carboplatin","cisplatin","pemetrexed","paclitaxel","gemcitabine"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":["checkmate-816","keynote-671","nct04025879","neotorch"],"people":[],"bottlenecks":[],"keyPapers":["paper-heymach-aegean-perioperative-durvalumab-nejm-2023"],"journals":[],"dependsOn":[],"notes":["AEGEAN randomised patients with treatment-naive resectable stage II to IIIB(N2) disease 1:1 to four cycles of neoadjuvant platinum chemotherapy with durvalumab or placebo every three weeks, then twelve adjuvant cycles every four weeks. Efficacy was analysed in a modified intention-to-treat population of 740 that excluded documented EGFR and ALK aberrations. At the second planned interim analysis (data cutoff 10 May 2024, median follow-up 25.9 months) the event-free survival hazard ratio was 0.69 (0.55 to 0.88), with numerical improvements in disease-free survival (0.66, 0.47 to 0.92) and overall survival (0.89, 0.70 to 1.14). Maximum grade 3 or 4 adverse events during adjuvant treatment occurred in 15.4 percent on durvalumab and 10.6 percent on placebo (Journal of Clinical Oncology 2026)."],"nct":"NCT03800134","phase":"3","setting":"A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)","sponsor":"AstraZeneca","result":"Perioperative durvalumab with neoadjuvant platinum chemotherapy improved event-free survival (hazard ratio 0.69, 95 percent confidence interval 0.55 to 0.88 at the second interim analysis) and pathological complete response in resectable stage II to IIIB(N2) non-small-cell lung cancer.","started":"2018-12-06","startedType":"actual","yearReported":2023,"enrolled":825,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03431350","kind":"trial","name":"A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer","aka":["QUEST"],"tldr":"A phase 2 trial of Niraparib, Cetrelimab, Abiraterone acetate and Prednisone in prostate cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer is a phase 2 interventional study registered as NCT03431350 by Janssen Research & Development, LLC, with 136 participants enrolled, started 2018-03-02 and due to reach its primary completion in 2021-08-31. Interventions recorded: Niraparib 200 mg, Cetrelimab 240 mg, Cetrelimab 480 mg, Abiraterone acetate 1000 mg and Prednisone 5 mg. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03431350","url":"https://clinicaltrials.gov/study/NCT03431350"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["niraparib","cetrelimab","abiraterone","prednisone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03431350","phase":"2","setting":"A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer","sponsor":"Janssen Research & Development, LLC","started":"2018-03-02","startedType":"actual","yearReported":2023,"enrolled":136,"enrolledBasis":"registry","outcomes":[{"endpoint":"Combination 1: Part 2: Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg","n":21,"value":23.8,"note":"95% CI 9.9 to 43.7; Figures from the ClinicalTrials.gov results section (first posted 2023-11-18), not from a publication"},{"name":"Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg","n":11,"value":9.1,"note":"95% CI 0.5 to 36.4"}],"source":"https://clinicaltrials.gov/study/NCT03431350?tab=results"}]},{"id":"nct04497844","kind":"trial","name":"A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-MutatedProstatic Neoplasms (mCSPC)","aka":["AMPLITUDE"],"tldr":"A phase 3 trial of Abiraterone acetate, Niraparib and Prednisone in prostate cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-MutatedProstatic Neoplasms (mCSPC) is a phase 3 interventional study registered as NCT04497844 by Janssen Research & Development, LLC, with 696 participants enrolled, started 2020-09-23 and due to reach its primary completion in 2025-01-07. Interventions recorded: Niraparib+ Abiraterone acetate fixed dose combination (FDC), Abiraterone acetate (AA), Prednisone, Placebo FDC and Placebo AA. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04497844","url":"https://clinicaltrials.gov/study/NCT04497844"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation","parp-inhibitor"],"targets":[],"drugs":["abiraterone","niraparib","prednisone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04497844-nat-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04497844","phase":"3","setting":"A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)","sponsor":"Janssen Research & Development, LLC","started":"2020-09-23","startedType":"actual","yearReported":2026,"enrolled":696,"enrolledBasis":"registry","outcomes":[{"endpoint":"Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator","primary":true,"unit":"months","arms":[{"name":"BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone","n":196,"value":25.99,"note":"95% CI 22.11 to 41.17; Figures from the ClinicalTrials.gov results section (first posted 2026-01-22), not from a publication"},{"name":"BRCA Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone","n":191,"note":"Median and the upper limit of the 95% confidence interval (CI) were not estimable due to an insufficient number of participants with events."}],"hr":0.515,"ci":[0.37,0.717],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT04497844?tab=results"},{"endpoint":"HRR Effector Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator","primary":true,"unit":"months","arms":[{"name":"HRR Effector Subgroup: Placebo With Abiraterone Acetate Plus Prednisone","n":226,"value":27.56,"note":"95% CI 25.59 to NA; Figures from the ClinicalTrials.gov results section (first posted 2026-01-22), not from a publication"},{"name":"HRR Effector Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone","n":230,"note":"Median and the upper limit of the 95% CI were not estimable due to an insufficient number of participants with events."}],"hr":0.571,"ci":[0.421,0.774],"p":"0.0003","source":"https://clinicaltrials.gov/study/NCT04497844?tab=results"},{"endpoint":"All HRR: Radiographic Progression-free Survival (rPFS) Assessed by Investigator","primary":true,"unit":"months","arms":[{"name":"Placebo With Abiraterone Acetate Plus Prednisone","n":348,"value":29.54,"note":"95% CI 25.82 to NA; Figures from the ClinicalTrials.gov results section (first posted 2026-01-22), not from a publication"},{"name":"Niraparib With Abiraterone Acetate Plus Prednisone","n":348,"note":"Median and the upper limit of the 95% CI were not estimable due to an insufficient number of participants with events."}],"hr":0.625,"ci":[0.49,0.799],"p":"0.0001","source":"https://clinicaltrials.gov/study/NCT04497844?tab=results"}]},{"id":"nct07170644","kind":"trial","name":"A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF)","aka":[],"tldr":"A phase 2 trial of Nirogacestat in desmoid tumour, run by SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, active and no longer recruiting.","summary":"A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF) is a phase 2 interventional study registered as NCT07170644 by SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, with 20 participants enrolled, started 2025-08-08 and due to reach its primary completion in 2027-05-28. Interventions recorded: Nirogacestat oral tablet. Conditions listed: Desmoid Tumor, Aggressive Fibromatosis. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07170644","url":"https://clinicaltrials.gov/study/NCT07170644"}],"tags":["ctgov-ingest"],"related":[],"cancers":["desmoid-tumour"],"sections":[],"technologies":["gamma-secretase-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["nirogacestat"],"companies":["merck-kgaa"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07170644","phase":"2","setting":"A Single-arm, Open-label Phase 2 Study of Nirogacestat in Adult Japanese Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)","sponsor":"SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany","started":"2025-08-08","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03873402","kind":"trial","name":"A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer","aka":[],"tldr":"A phase 3 trial of Nivolumab, Ipilimumab in renal cell carcinoma, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer is a phase 3 interventional study registered as NCT03873402 by Bristol-Myers Squibb, with 437 participants enrolled, started 2019-06-21 and due to reach its primary completion in 2027-03-11. Interventions recorded: Nivolumab, Ipilimumab, Ipilimumab placebo. Conditions listed: Renal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03873402","url":"https://clinicaltrials.gov/study/NCT03873402"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03873402","phase":"3","setting":"A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors","sponsor":"Bristol-Myers Squibb","started":"2019-06-21","startedType":"actual","enrolled":437,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03383458","kind":"trial","name":"A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation","aka":["CheckMate 9DX"],"tldr":"A phase 3 trial of Nivolumab in hepatocellular carcinoma, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation is a phase 3 interventional study registered as NCT03383458 by Bristol-Myers Squibb, with 545 participants enrolled, started 2018-04-18 and due to reach its primary completion in 2026-05-27. Interventions recorded: Nivolumab, Placebo. Conditions listed: Hepatocellular Carcinoma, Liver Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03383458","url":"https://clinicaltrials.gov/study/NCT03383458"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03383458","phase":"3","setting":"A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation","sponsor":"Bristol-Myers Squibb","started":"2018-04-18","startedType":"actual","enrolled":545,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03635983","kind":"trial","name":"A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma","aka":[],"tldr":"A phase 3 trial of Bempegaldesleukin and Nivolumab in Melanoma, run by Bristol-Myers Squibb, completed.","summary":"A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma is a phase 3 interventional study registered as NCT03635983 by Bristol-Myers Squibb, with 783 participants recorded, started 2018-09-21 and reaching its primary completion in 2021-11-19. Interventions recorded: NKTR-214, Nivolumab. Conditions recorded: Melanoma.\n\nLinked to the drug Bempegaldesleukin because the registry names it among its interventions and Melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03635983","url":"https://clinicaltrials.gov/study/NCT03635983"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["bempegaldesleukin","nivolumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03635983","phase":"3","setting":"A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma","sponsor":"Bristol-Myers Squibb","started":"2018-09-21","startedType":"actual","yearReported":2022,"enrolled":783,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)","primary":true,"unit":"%","arms":[{"name":"Bempegaldesleukin + Nivolumab","n":271,"value":27.7,"note":"95% CI 22.4 to 33.4; Figures from the ClinicalTrials.gov results section (first posted 2022-12-19), not from a publication"},{"name":"Nivolumab","n":272,"value":36,"note":"95% CI 30.3 to 42.0"}],"p":"0.0311","source":"https://clinicaltrials.gov/study/NCT03635983?tab=results"},{"endpoint":"Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)","primary":true,"unit":"months","arms":[{"name":"Bempegaldesleukin + Nivolumab","n":391,"value":4.17,"note":"95% CI 3.52 to 5.55; Figures from the ClinicalTrials.gov results section (first posted 2022-12-19), not from a publication"},{"name":"Nivolumab","n":392,"value":4.99,"note":"95% CI 4.14 to 7.82"}],"hr":1.09,"ci":[0.89,1.33],"p":"0.3988","source":"https://clinicaltrials.gov/study/NCT03635983?tab=results"},{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Bempegaldesleukin + Nivolumab","n":391,"value":29.67,"note":"95% CI 22.14 to NA; Figures from the ClinicalTrials.gov results section (first posted 2022-12-19), not from a publication"},{"name":"Nivolumab","n":392,"value":28.88,"note":"95% CI 21.32 to NA"}],"hr":0.94,"ci":[0.72,1.22],"p":"0.6361","source":"https://clinicaltrials.gov/study/NCT03635983?tab=results"}]},{"id":"nct04194775","kind":"trial","name":"A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma","aka":[],"tldr":"A phase 3 trial of Lenvatinib in hepatocellular carcinoma, run by CStone Pharmaceuticals, active and no longer recruiting.","summary":"A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma is a phase 3 interventional study registered as NCT04194775 by CStone Pharmaceuticals, with 534 participants enrolled, started 2019-12-13 and due to reach its primary completion in 2025-06-18. Interventions recorded: Nofazinlimab (CS1003)+Lenvatinib, Nofazinlimab (CS1003) Placebo+Lenvatinib. Conditions listed: Hepatocellular Carcinoma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04194775","url":"https://clinicaltrials.gov/study/NCT04194775"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["lenvatinib"],"companies":["cstone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04194775","phase":"3","setting":"A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of Nofazinlimab (CS1003) in Combination With Lenvatinib Compared to Placebo in Combination With Lenvatinib as First-Line Therapy in Subjects With Advanced Hepatocellular Carcinoma (HCC)","sponsor":"CStone Pharmaceuticals","started":"2019-12-13","startedType":"actual","yearReported":2026,"enrolled":534,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Nofazinlimab + Lenvatinib","n":353,"value":21.6,"note":"95% CI 18.6 to 24.6; Figures from the ClinicalTrials.gov results section (first posted 2026-07-30), not from a publication"},{"name":"Placebo + Lenvatinib","n":181,"value":18.5,"note":"95% CI 14.7 to 21.8"}],"source":"https://clinicaltrials.gov/study/NCT04194775?tab=results"}]},{"id":"nct07069712","kind":"trial","name":"A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma","aka":["GEMINI-PeriOp GC"],"tldr":"A phase 2 trial of Sonesitatug vedotin, Rilvegostomig, Trastuzumab, Trastuzumab deruxtecan, Capecitabine and Fluorouracil (5-FU) in oesophageal cancer, run by AstraZeneca, now recruiting.","summary":"A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma is a phase 2 interventional study registered as NCT07069712 by AstraZeneca, with 100 participants planned, started 2025-07-17 and due to reach its primary completion in 2027-11-03. Interventions recorded: Sonesitatug Vedotin, Rilvegostomig, Trastuzumab Deruxtecan (T-DXd), Capecitabine, 5-Fluorouracil (5-FU) and FLOT Chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07069712","url":"https://clinicaltrials.gov/study/NCT07069712"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal","oesophageal-adenocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["cmg901","rilvegostomig","trastuzumab","trastuzumab-deruxtecan","capecitabine","fluorouracil"],"companies":["astrazeneca","parexel"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07069712","phase":"2","setting":"A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)","sponsor":"AstraZeneca","started":"2025-07-17","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03742102","kind":"trial","name":"A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer","aka":["BEGONIA"],"tldr":"A phase 1/2 trial of Durvalumab, Capivasertib, Oleclumab, Trastuzumab deruxtecan and Datopotamab deruxtecan in triple-negative breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer is a phase 1/2 interventional study registered as NCT03742102 by AstraZeneca, with 243 participants enrolled, started 2018-12-21 and due to reach its primary completion in 2024-11-29. Interventions recorded: Durvalumab, Capivasertib, Oleclumab, Paclitaxel, Trastuzumab deruxtecan and Datopotamab deruxtecan. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03742102","url":"https://clinicaltrials.gov/study/NCT03742102"},{"label":"BEGONIA arms 7 and 8 (Annals of Oncology 2026)","url":"https://doi.org/10.1016/j.annonc.2026.05.693"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","capivasertib","oleclumab","trastuzumab-deruxtecan","datopotamab-deruxtecan"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03742102-ann-oncol-2026"],"journals":[],"dependsOn":[],"notes":["BEGONIA arms 7 and 8 (Annals of Oncology 2026): first-line datopotamab deruxtecan 6 mg/kg with durvalumab 1,120 mg every 3 weeks in 62 patients regardless of PD-L1 (arm 7) and 33 with PD-L1-high tumours (arm 8); confirmed response 79.0 and 81.8 percent, arm 7 median duration of response 17.6 months and progression-free survival 14.0 months with overall survival not reached at 35 months of follow-up. This is the phase 2 basis of TROPION-Breast05. UK sites: Cambridge, London, Manchester, Oxford."],"nct":"NCT03742102","phase":"1/2","setting":"A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer","sponsor":"AstraZeneca","started":"2018-12-21","startedType":"actual","yearReported":2026,"enrolled":243,"enrolledBasis":"registry","outcomes":[{"endpoint":"Dose Limiting Toxicity (DLT) Events","primary":true,"unit":"participants","arms":[{"name":"Arm 2","n":6,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2026-02-02), not from a publication"},{"name":"Arm 5","n":6,"value":0},{"name":"Arm 6","n":6,"value":0},{"name":"Arm 7","n":6,"value":0}],"source":"https://clinicaltrials.gov/study/NCT03742102?tab=results"},{"endpoint":"Overall Survival (Duration)","unit":"months","arms":[{"name":"Arm 1","n":23,"value":30,"note":"95% CI 13.0 to NA; Figures from the ClinicalTrials.gov results section (first posted 2026-02-02), not from a publication"},{"name":"Arm 2","n":31,"value":32.6,"note":"95% CI 12.9 to 40.0"},{"name":"Arm 5","n":33,"value":24.8,"note":"95% CI 18.6 to 31.9"},{"name":"Arm 6","n":58,"value":30.3,"note":"95% CI 18.8 to NA"},{"name":"Arm 7","n":62,"note":"NA - Not calculable due to insufficient number of events for upper limit of confidence interval"},{"name":"Arm 8","n":33,"note":"NA - Not calculable due to insufficient number of events for upper limit of confidence interval"}],"source":"https://clinicaltrials.gov/study/NCT03742102?tab=results"},{"endpoint":"Progression-free Survival (PFS)","unit":"months","arms":[{"name":"Arm 1","n":23,"value":7.3,"note":"95% CI 5.4 to 11.3; Figures from the ClinicalTrials.gov results section (first posted 2026-02-02), not from a publication"},{"name":"Arm 2","n":31,"value":6.4,"note":"95% CI 5.4 to 10.3"},{"name":"Arm 5","n":33,"value":8.3,"note":"95% CI 4.8 to 9.3"},{"name":"Arm 6","n":58,"value":12.6,"note":"95% CI 8.4 to 16.3"},{"name":"Arm 7","n":62,"value":14,"note":"95% CI 11.0 to 21.1"},{"name":"Arm 8","n":33,"value":11.2,"note":"95% CI 6.9 to 13.8"}],"source":"https://clinicaltrials.gov/study/NCT03742102?tab=results"}]},{"id":"nct07098338","kind":"trial","name":"A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)","aka":["LIBRA"],"tldr":"A phase 2 trial of Rilvegostomig, Ramucirumab, Datopotamab deruxtecan in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, now recruiting.","summary":"A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC) is a phase 2 interventional study registered as NCT07098338 by AstraZeneca, with 278 participants planned, started 2025-08-07 and due to reach its primary completion in 2029-04-06. Interventions recorded: Rilvegostomig, Ramucirumab, Dato-DXd. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07098338","url":"https://clinicaltrials.gov/study/NCT07098338"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["rilvegostomig","ramucirumab","datopotamab-deruxtecan"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07098338","phase":"2","setting":"An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)","sponsor":"AstraZeneca","started":"2025-08-07","startedType":"actual","enrolled":278,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06792695","kind":"trial","name":"A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer","aka":["CANTOR"],"tldr":"A phase 2 trial of FOLFIRI, Fluorouracil, FLOT in colorectal cancer, run by AstraZeneca, now recruiting.","summary":"A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer is a phase 2 interventional study registered as NCT06792695 by AstraZeneca, with 80 participants planned, started 2025-03-12 and due to reach its primary completion in 2027-06-30. Interventions recorded: Volrustomig, FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan), Bevacizumab. Conditions listed: Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06792695","url":"https://clinicaltrials.gov/study/NCT06792695"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["folfiri","fluorouracil","flot","bevacizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06792695","phase":"2","setting":"A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)","sponsor":"AstraZeneca","started":"2025-03-12","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05624918","kind":"trial","name":"A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma","aka":["NovoTTF-200T"],"tldr":"A phase 2 trial of nab-paclitaxel, gemcitabine and optune / Optune Pax (TTFields) in pancreatic cancer, run by Ashish Manne, now recruiting.","summary":"A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma is a phase 2, interventional study registered as NCT05624918 by Ashish Manne, with a registry enrolment figure of 38 participants, started 2024-07-01 and due to reach its primary completion in 2027-08-29. Interventions recorded: Nab paclitaxel; Gemcitabine; NovoTTF-200T(P). Conditions listed: Pancreatic Adenocarcinoma; Resectable Pancreatic Cancer. Primary outcome: 2 Year Overall Survival (OS); Rate of Resection. Pancreatic eligibility wording from the registry: \"* Histological or cytological evidence of pancreatic adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05624918","url":"https://clinicaltrials.gov/study/NCT05624918"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","ttfields"],"targets":[],"drugs":["nab-paclitaxel","gemcitabine","optune"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05624918","phase":"2","setting":"A Phase II Study of Peri-Operative NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma","sponsor":"Ashish Manne","started":"2024-07-01","startedType":"actual","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07450859","kind":"trial","name":"A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)","aka":[],"tldr":"A phase 2 trial of nuzefatide pevedotin (BT5528) in pancreatic ductal adenocarcinoma, run by BicycleTx Limited, now recruiting.","summary":"A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) is a phase 2 interventional study registered as NCT07450859 by BicycleTx Limited, with 39 participants planned, started 2026-03-05 and due to reach its primary completion in 2029-03. Interventions recorded: nuzefatide pevedotin (BT5528).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07450859","url":"https://clinicaltrials.gov/study/NCT07450859"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bicycle-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07450859","phase":"2","setting":"A Phase 2 Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma","sponsor":"BicycleTx Limited","started":"2026-03-05","startedType":"actual","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07221500","kind":"trial","name":"A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor (DAYBreak CLL-201)","aka":["DAYBreak CLL-201"],"tldr":"A phase 2 trial of Bexobrutideg in chronic lymphocytic leukaemia, run by Nurix Therapeutics, Inc., now recruiting.","summary":"A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor (DAYBreak CLL-201) is a phase 2 interventional study registered as NCT07221500 by Nurix Therapeutics, Inc., with 100 participants planned, started 2025-10-15 and due to reach its primary completion in 2028-01. Interventions recorded: NX-5948.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07221500","url":"https://clinicaltrials.gov/study/NCT07221500"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":[],"targets":[],"drugs":["bexobrutideg"],"companies":["nurix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07221500","phase":"2","setting":"A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults With Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton's Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)","sponsor":"Nurix Therapeutics, Inc.","started":"2025-10-15","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06365853","kind":"trial","name":"A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer Wit","aka":[],"tldr":"A phase 2 trial of Mirvetuximab soravtansine in ovarian cancer, run by AbbVie, active and no longer recruiting.","summary":"A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression is a phase 2 interventional study registered as NCT06365853 by AbbVie, with 108 participants enrolled, started 2024-07-29 and due to reach its primary completion in 2027-02. Interventions recorded: Mirvetuximab Soravtansine, Lubricating Eye Drops, Prednisolone acetate ophthalmic suspension 1% eye drops, Brimonidine tartrate ophthalmic solution eye drops. Conditions listed: Recurrent Ovarian Cancer, Folate Receptor-Alpha Positive. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06365853","url":"https://clinicaltrials.gov/study/NCT06365853"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["mirvetuximab-soravtansine"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06365853","phase":"2","setting":"A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Patients With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression","sponsor":"AbbVie","started":"2024-07-29","startedType":"actual","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07814417","kind":"trial","name":"A Study of Olomorasib (LY3537982) in Participants With Advanced Colorectal Cancer and a KRAS G12C Mutation","aka":[],"tldr":"A phase 2 trial of olomorasib, cetuximab, fOLFOX (5-FU, leucovorin, oxaliplatin) and fluorouracil (5-FU) in colorectal cancer, run by Eli Lilly and Company, not yet recruiting.","summary":"A Study of Olomorasib (LY3537982) in Participants With Advanced Colorectal Cancer and a KRAS G12C Mutation is a phase 2, interventional study registered as NCT07814417 by Eli Lilly and Company, with a registry enrolment figure of 50 participants, started 2026-10 and due to reach its primary completion in 2028-11. Interventions recorded: Olomorasib; Cetuximab; Oxaliplatin; Leucovorin/levofolinate calcium; 5-fluorouracil. Conditions listed: Colorectal Neoplasms. Primary outcome: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; Progression-Free Survival (PFS) Per RECIST v1.1. Colorectal eligibility wording from the registry: \"* Histologically or cytologically confirmed colorectal cancer (CRC) with Stage III or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07814417","url":"https://clinicaltrials.gov/study/NCT07814417"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","kras-g12c-colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","kras-inhibitors","monoclonal-antibody","platinum"],"targets":[],"drugs":["olomorasib","cetuximab","folfox","fluorouracil"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07814417","phase":"2","setting":"A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Olomorasib in Combination With Cetuximab and mFOLFOX6 in Participants With KRAS G12C-Mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer","sponsor":"Eli Lilly and Company","started":"2026-10","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06051409","kind":"trial","name":"A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)","aka":["POLARIS-1"],"tldr":"A phase 3 trial of Olverembatinib run by Ascentage Pharma Group Inc., now recruiting.","summary":"A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1) is a phase 3 interventional study registered as NCT06051409 by Ascentage Pharma Group Inc., with 350 participants planned, started 2023-08-31. Conditions listed: Ph+ ALL, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06051409","url":"https://clinicaltrials.gov/study/NCT06051409"}],"tags":["ctgov-ingest"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["olverembatinib"],"companies":["ascentage-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06051409","phase":"3","setting":"A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Investigator's Choice of TKI Combined With Chemotherapy in Patients With Newly Diagnosed Ph+ ALL","sponsor":"Ascentage Pharma Group Inc.","started":"2023-08-31","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06640361","kind":"trial","name":"A Study of Olverembatinib in SDH-deficient GIST.","aka":["POLARIS-3"],"tldr":"A phase 3 trial of Olverembatinib run by Ascentage Pharma Group Inc., now recruiting.","summary":"A Study of Olverembatinib in SDH-deficient GIST. is a phase 3 interventional study registered as NCT06640361 by Ascentage Pharma Group Inc., with 40 participants planned, started 2024-11-11. Conditions listed: GIST. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06640361","url":"https://clinicaltrials.gov/study/NCT06640361"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gist"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["olverembatinib"],"companies":["ascentage-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06640361","phase":"3","setting":"A Single-Arm Registrational Phase III Study of Olverembatinib in the Treatment of Patients With SDH-Deficient Gastrointestinal Stromal Tumor (POLARIS-3)","sponsor":"Ascentage Pharma Group Inc.","started":"2024-11-11","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07734116","kind":"trial","name":"A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma.","aka":[],"tldr":"A phase 1/2 trial of ONO-4538HSC in epithelioid sarcoma, run by Ono Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma. is a phase 1/2 interventional study registered as NCT07734116 by Ono Pharmaceutical Co., Ltd., with 50 participants planned, started 2026-08-18 and due to reach its primary completion in 2029-11-30. Interventions recorded: ONO-4538HSC.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07734116","url":"https://clinicaltrials.gov/study/NCT07734116"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["epithelioid-sarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07734116","phase":"1/2","setting":"A Multicenter, Open-label, Uncontrolled Phase I/II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma, and to Evaluate the Tolerability in Pediatric Patients.","sponsor":"Ono Pharmaceutical Co., Ltd.","started":"2026-08-18","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06136650","kind":"trial","name":"A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)","aka":["OMAHA-004"],"tldr":"A phase 3 trial testing Opevesostat in prostate cancer, now recruiting.","summary":"A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) is a phase 3 interventional study registered as NCT06136650, led by Merck Sharp & Dohme, and recruiting on the registry. Official title: MK-5684-004: A Phase 3, Randomised, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004). Planned enrolment is 1314 participants (estimated). The study started in 2023-12-18 and primary completion is expected in 2028-05-10. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06136650","url":"https://clinicaltrials.gov/study/NCT06136650"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["opevesostat"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06136650","phase":"3","setting":"MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)","sponsor":"Merck Sharp & Dohme","started":"2023-12-18","startedType":"actual","enrolled":1314,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06090266","kind":"trial","name":"A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents","aka":[],"tldr":"A phase 1/2 trial of Cemiplimab in metastatic cancer and melanoma, run by OncoResponse, Inc., now recruiting.","summary":"A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents is a phase 1/2 interventional study registered as NCT06090266 by OncoResponse, Inc., with 168 participants planned, started 2023-10-24 and due to reach its primary completion in 2026-08-01. Interventions recorded: OR502, Cemiplimab. Conditions listed: Cancer, Tumor, Solid, Malignant Neoplasm, Metastatic Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06090266","url":"https://clinicaltrials.gov/study/NCT06090266"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","melanoma","nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["cemiplimab","or502"],"companies":["oncoresponse"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06090266","phase":"1/2","setting":"A Phase 1/2 Study of OR502 Alone and in Combination With Other Anti-cancer Agents in Subjects With Advanced Malignancies","sponsor":"OncoResponse, Inc.","started":"2023-10-24","startedType":"actual","enrolled":168,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06362369","kind":"trial","name":"A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy","aka":[],"tldr":"A phase 1/2 trial of Ipilimumab, Nivolumab in metastatic cancer and melanoma, run by 7 Hills Pharma, LLC, now recruiting.","summary":"A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy is a phase 1/2 interventional study registered as NCT06362369 by 7 Hills Pharma, LLC, with 126 participants planned, started 2024-08-23 and due to reach its primary completion in 2027-12-31. Interventions recorded: Alintegimod, Ipilimumab, Nivolumab. Conditions listed: Advanced Cancer, Advanced Solid Tumor, Melanoma, Metastasis. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06362369","url":"https://clinicaltrials.gov/study/NCT06362369"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","melanoma","mesothelioma","rcc","colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ipilimumab","nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06362369","phase":"1/2","setting":"A Phase 1b/2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy in Patients With Locally Advanced or Metastatic Cancers Following One or More Prior Therapies","sponsor":"7 Hills Pharma, LLC","started":"2024-08-23","startedType":"actual","enrolled":126,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04971226","kind":"trial","name":"A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP","aka":["ASC4FIRST"],"tldr":"A phase 3 trial of Imatinib, Nilotinib, Bosutinib, Dasatinib and Asciminib in chronic myeloid leukaemia, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP is a phase 3 interventional study registered as NCT04971226 by Novartis Pharmaceuticals, with 405 participants enrolled, started 2021-10-06 and due to reach its primary completion in 2023-11-28. Interventions recorded: Imatinib, Nilotinib, Bosutinib, Dasatinib and Asciminib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04971226","url":"https://clinicaltrials.gov/study/NCT04971226"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cml","cml-chronic-phase"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["imatinib","nilotinib","bosutinib","dasatinib","asciminib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04971226","phase":"3","setting":"A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase","sponsor":"Novartis Pharmaceuticals","started":"2021-10-06","startedType":"actual","yearReported":2025,"enrolled":405,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI","primary":true,"unit":"participants","arms":[{"name":"Asciminib (All Asciminib )","n":201,"value":136,"note":"Figures from the ClinicalTrials.gov results section (first posted 2025-03-10), not from a publication"},{"name":"Investigator Selected TKI (All Comparators)","n":204,"value":100}],"p":"<0.001","source":"https://clinicaltrials.gov/study/NCT04971226?tab=results"}]},{"id":"nct03899792","kind":"trial","name":"A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors","aka":["LIBRETTO-121"],"tldr":"A phase 1/2 trial of Selpercatinib in thyroid cancer and sarcomas, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors is a phase 1/2 interventional study registered as NCT03899792 by Eli Lilly and Company, with 36 participants enrolled, started 2019-06-13 and due to reach its primary completion in 2024-11-08. Interventions recorded: Selpercatinib. Conditions listed: Medullary Thyroid Cancer, Infantile Myofibromatosis, Infantile Fibrosarcoma, Papillary Thyroid Cancer. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03899792","url":"https://clinicaltrials.gov/study/NCT03899792"}],"tags":["ctgov-ingest"],"related":[],"cancers":["thyroid","sarcoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["selpercatinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03899792","phase":"1/2","setting":"A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors","sponsor":"Eli Lilly and Company","started":"2019-06-13","startedType":"actual","yearReported":2026,"enrolled":36,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase 2: Percentage of Participants With Overall Response Rate (ORR) in Study","primary":true,"unit":"%","arms":[{"name":"Cohort 1 (Phase 2): MTC Group","n":15,"value":60,"note":"Figures from the ClinicalTrials.gov results section (first posted 2026-01-06), not from a publication"},{"name":"Cohort 2 (Phase 2): PTC Group","n":15,"value":53.3},{"name":"Cohort 3 (Phase 2): Other Cancer Group","n":6,"value":33.3}],"source":"https://clinicaltrials.gov/study/NCT03899792?tab=results"}]},{"id":"nct04351555","kind":"trial","name":"A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-S","aka":["NeoADAURA"],"tldr":"A phase 3 trial of Osimertinib, Cisplatin, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT04351555 by AstraZeneca, with 358 participants enrolled, started 2020-12-16 and due to reach its primary completion in 2024-10-15. Interventions recorded: Osimertinib, Cisplatin, Carboplatin, Placebo, Pemetrexed. Conditions listed: Non-Small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04351555","url":"https://clinicaltrials.gov/study/NCT04351555"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib","cisplatin","carboplatin","pemetrexed"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04351555","phase":"3","setting":"A Phase III, Randomised, Controlled, Multi-center, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer","sponsor":"AstraZeneca","started":"2020-12-16","startedType":"actual","yearReported":2026,"enrolled":358,"enrolledBasis":"registry","outcomes":[{"endpoint":"Major Pathological Response (MPR) - IASLC Method","primary":true,"unit":"%","arms":[{"name":"Osimertinib + Chemo","n":121,"value":25.6,"note":"95% CI 18.1 to 34.4; Figures from the ClinicalTrials.gov results section (first posted 2026-06-05), not from a publication"},{"name":"Osimertinib","n":117,"value":24.8,"note":"95% CI 17.3 to 33.6"},{"name":"Placebo + Chemo","n":120,"value":1.7,"note":"95% CI 0.2 to 5.9"}],"source":"https://clinicaltrials.gov/study/NCT04351555?tab=results"}]},{"id":"nct07058519","kind":"trial","name":"A Study of Osimertinib-based Adaptive Treatment Guided by ctDNA EGFRm+ Monitoring in NSCLC","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Shanghai Chest Hospital, now recruiting.","summary":"A Study of Osimertinib-based Adaptive Treatment Guided by ctDNA EGFRm+ Monitoring in NSCLC is a phase 2, interventional study registered as NCT07058519 by Shanghai Chest Hospital, with a registry enrolment figure of 250 participants, started 2025-09-23 and due to reach its primary completion in 2029-01-24. Interventions recorded: Osimertinib-based adaptive treatment; Osimertinib 80 MG. Conditions listed: Locally Advanced or Metastatic EGFRm Non-small Cell Lung Cancer (NSCLC). Primary outcome: Progression-Free Survival (PFS) in Cohort 1; Time to First ctDNA EGFRm Relapse or Death in Cohort 1. Lung eligibility wording from the registry: \"Newly diagnosed, and histologically documented locally advanced or metastatic non-squamous NSCLC with sensitizing EGFR mutations positive (either Exon 19 deletion or 21 L858R, confirmed by histology or cytology), and classified as stage IIIB, IIIC, IV or recurrent NSCLC which are not amenable to cur\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07058519","url":"https://clinicaltrials.gov/study/NCT07058519"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07058519","phase":"2","setting":"The Efficacy and Safety of Osimertinib-based Adaptive Treatment Guided by Circulating Tumour DNA (ctDNA) Epidermal Growth Factor Receptor Mutation-positive (EGFRm) Dynamic Monitoring in Locally Advanced or Metastatic EGFRm Non-small Cell Lung Cancer (NSCLC) Participants With ctDNA EGFRm Clearance After First-line Osimertinib Plus Chemotherapy: A Phase II, Multicentre, Prospective Study (Adaptive)","sponsor":"Shanghai Chest Hospital","started":"2025-09-23","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06079346","kind":"trial","name":"A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer","aka":["STOP-PC"],"tldr":"A phase 2/3 trial testing Trabedersen in pancreatic ductal adenocarcinoma, now recruiting.","summary":"A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer is a phase 2/3 interventional study registered as NCT06079346, led by Oncotelic, and recruiting on the registry. Official title: A Randomised Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination With mFOLFIRINOX Compared With mFOLFIRINOX Alone in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer. Planned enrolment is 455 participants (estimated). The study started in 2024-05-01 and primary completion is expected in 2026-06-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06079346","url":"https://clinicaltrials.gov/study/NCT06079346"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["trabedersen"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06079346","phase":"2/3","setting":"A Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination With mFOLFIRINOX Compared With mFOLFIRINOX Alone in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer","sponsor":"Oncotelic","started":"2024-05-01","startedType":"actual","enrolled":455,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07266428","kind":"trial","name":"A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of OTP-01 in advanced solid tumours, run by Ottimo Pharma Limited, now recruiting.","summary":"A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07266428 by Ottimo Pharma Limited, with 170 participants planned, started 2025-12-17 and due to reach its primary completion in 2028-12. Interventions recorded: OTP-01.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07266428","url":"https://clinicaltrials.gov/study/NCT07266428"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["pd1"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07266428","phase":"1/2","setting":"Phase 1/2A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors","sponsor":"Ottimo Pharma Limited","started":"2025-12-17","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00434161","kind":"trial","name":"A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma","aka":[],"tldr":"A phase 3 trial of Palifermin in Multiple myeloma, run by Swedish Orphan Biovitrum, completed.","summary":"A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma is a phase 3 interventional study registered as NCT00434161 by Swedish Orphan Biovitrum, with 281 participants recorded, started 2006-12 and reaching its primary completion in 2009-03. Interventions recorded: Palifermin before only, Placebo, Palifermin before and after. Conditions recorded: Multiple Myeloma.\n\nLinked to the drug Palifermin because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00434161","url":"https://clinicaltrials.gov/study/NCT00434161"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["palifermin"],"companies":["sobi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00434161","phase":"3","setting":"A Double-Blind, Randomized, Placebo-controlled Study of Two Different Schedules of Palifermin for Reduction in Severity of Oral Mucositis in Subjects With Multiple Myeloma Receiving Melphalan Followed by Autologous Blood Stem Cell Transplantation","sponsor":"Swedish Orphan Biovitrum","started":"2006-12","yearReported":2015,"enrolled":281,"enrolledBasis":"registry","outcomes":[{"endpoint":"Incidence of Cataract Development or Progression at Month 12., Yes","primary":true,"unit":"participants","arms":[{"name":"Placebo","n":22,"value":4,"note":"Figures from the ClinicalTrials.gov results section (first posted 2015-03-10), not from a publication"},{"name":"Palifermin","n":79,"value":25}],"source":"https://clinicaltrials.gov/study/NCT00434161?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"Palifermin (Palifermin Before Only and, Before and After)","n":220,"value":50.6,"note":"IQR 35.9 to NA; Figures from the ClinicalTrials.gov results section (first posted 2015-03-10), not from a publication"},{"name":"Placebo","n":57,"note":"Median and quartile 3 values are not available because a small number of participants died."}],"hr":0.64,"ci":[0.33,1.26],"p":"0.192","source":"https://clinicaltrials.gov/study/NCT00434161?tab=results"},{"endpoint":"Progression Free Survival","unit":"months","arms":[{"name":"Palifermin (Palifermin Before Only and, Before and After)","n":220,"value":15.1,"note":"IQR 8.4 to 24.0; Figures from the ClinicalTrials.gov results section (first posted 2015-03-10), not from a publication"},{"name":"Placebo","n":57,"value":18.3,"note":"IQR 11.9 to 27.5"}],"hr":0.8,"ci":[0.55,1.16],"p":"0.236","source":"https://clinicaltrials.gov/study/NCT00434161?tab=results"}]},{"id":"nct06395519","kind":"trial","name":"A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies","aka":["ERADIC8"],"tldr":"A phase 1/2 trial of ETX-19477 in ovarian cancer, prostate cancer, endometrial cancer, colorectal cancer and gastric & gastro-oesophageal junction cancer, run by 858 Therapeutics, Inc., now recruiting.","summary":"A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies is a phase 1/2 interventional study registered as NCT06395519 by 858 Therapeutics, Inc., with 120 participants planned, started 2024-05-13 and due to reach its primary completion in 2026-12. Interventions recorded: ETX-19477.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06395519","url":"https://clinicaltrials.gov/study/NCT06395519"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","prostate","endometrial","colorectal","gastric"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06395519","phase":"1/2","setting":"A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies","sponsor":"858 Therapeutics, Inc.","started":"2024-05-13","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06987500","kind":"trial","name":"A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment","aka":[],"tldr":"A phase 1/2 trial of XNW29016 in advanced solid tumours, run by Evopoint Biosciences Inc., now recruiting.","summary":"A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment is a phase 1/2 interventional study registered as NCT06987500 by Evopoint Biosciences Inc., with 132 participants planned, started 2025-04-11 and due to reach its primary completion in 2027-02-14. Interventions recorded: XNW29016.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06987500","url":"https://clinicaltrials.gov/study/NCT06987500"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["evopoint-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06987500","phase":"1/2","setting":"A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of XNW29016 Tablets in Advanced Solid Tumors With Failed Standard Treatment","sponsor":"Evopoint Biosciences Inc.","started":"2025-04-11","startedType":"actual","enrolled":132,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06907043","kind":"trial","name":"A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.","aka":[],"tldr":"A phase 1/2 trial of EIK1004-001 (IMP1707-001) in advanced solid tumours, run by Eikon Therapeutics, now recruiting.","summary":"A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors. is a phase 1/2 interventional study registered as NCT06907043 by Eikon Therapeutics, with 130 participants planned, started 2025-04-30 and due to reach its primary completion in 2028-12. Interventions recorded: EIK1004-001 (IMP1707-001).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06907043","url":"https://clinicaltrials.gov/study/NCT06907043"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["eikon-therapeutics","impact-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06907043","phase":"1/2","setting":"A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors","sponsor":"Eikon Therapeutics","started":"2025-04-30","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06099782","kind":"trial","name":"A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrol","aka":[],"tldr":"A phase 2 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11) is a phase 2 interventional study registered as NCT06099782 by Merck Sharp & Dohme LLC, with 147 participants enrolled, started 2023-12-26 and due to reach its primary completion in 2025-04-09. Interventions recorded: Pembrolizumab (+) Berahyaluronidase alfa, Pembrolizumab. Conditions listed: Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06099782","url":"https://clinicaltrials.gov/study/NCT06099782"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","rcc","melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct06099782-jco-oncol-pract-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06099782","phase":"2","setting":"A Phase 2 Study to Evaluate Patient Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab Formulation in Participants With Multiple Tumor Types (MK-3475A-F11)","sponsor":"Merck Sharp & Dohme LLC","started":"2023-12-26","startedType":"actual","yearReported":2026,"enrolled":147,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants Who Prefer Pembrolizumab Plus Berahyaluronidase Alfa Subcutaneous (SC) As Assessed By Patient Preference Questionnaire (PPQ) Question 1","primary":true,"unit":"%","arms":[{"name":"Full Analysis Set","n":118,"value":65.3,"note":"Figures from the ClinicalTrials.gov results section (first posted 2026-04-08), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT06099782?tab=results"}]},{"id":"nct07225946","kind":"trial","name":"A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Pasritamig, Docetaxel and Prednisone in prostate cancer, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer is a phase 3 interventional study registered as NCT07225946 by Janssen Research & Development, LLC, with 800 participants planned, started 2025-12-19 and due to reach its primary completion in 2027-11-19. Interventions recorded: Pasritamig, Docetaxel and Prednisone/Prednisolone.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07225946","url":"https://clinicaltrials.gov/study/NCT07225946"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["cytotoxic-chemotherapy","t-cell-engager"],"targets":[],"drugs":["pasritamig","docetaxel","prednisone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07225946","phase":"3","setting":"A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-engaging Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer","sponsor":"Janssen Research & Development, LLC","started":"2025-12-19","startedType":"actual","enrolled":800,"enrolledBasis":"registry","outcomes":[]},{"id":"mcrpc","kind":"trial","name":"A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)","aka":[],"tldr":"A phase 3 trial testing JNJ-87189401 in prostate cancer, now recruiting.","summary":"A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) is a phase 3 interventional study registered as NCT07164443, led by Janssen Research & Development, and recruiting on the registry. Official title: A Phase 3 Randomised, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Engaging Agent Targeting Human Kallikrein 2, With or Without JNJ-87189401, a PSMA-CD28 Costimulatory Agent, Plus Best Supportive Care Versus Best Supportive Care for Late-line Metastatic Castration-resistant Prostate Cancer. Planned enrolment is 1203 participants (estimated). The study started in 2025-09-02 and primary completion is expected in 2028-08-18. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07164443","url":"https://clinicaltrials.gov/study/NCT07164443"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["jnj-87189401"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07164443","phase":"3","setting":"A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Engaging Agent Targeting Human Kallikrein 2, With or Without JNJ-87189401, a PSMA-CD28 Costimulatory Agent, Plus Best Supportive Care Versus Best Supportive Care for Late-line Metastatic Castration-resistant Prostate Cancer","sponsor":"Janssen Research & Development","started":"2025-09-02","startedType":"actual","enrolled":1203,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06941272","kind":"trial","name":"A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)","aka":["LIGHTBEAM-U01"],"tldr":"A phase 1/2 trial of Patritumab deruxtecan in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01) is a phase 1/2 interventional study registered as NCT06941272 by Merck Sharp & Dohme LLC, with 50 participants planned, started 2025-05-26 and due to reach its primary completion in 2030-12-30. Interventions recorded: Patritumab Deruxtecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06941272","url":"https://clinicaltrials.gov/study/NCT06941272"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["patritumab-deruxtecan"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06941272","phase":"1/2","setting":"LIGHTBEAM-U01 Substudy 01C: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors","sponsor":"Merck Sharp & Dohme LLC","started":"2025-05-26","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"renaviv","kind":"trial","name":"A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)","aka":["RENAVIV"],"tldr":"A phase 3 trial testing Abexinostat in renal cell carcinoma, now recruiting.","summary":"A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV) is a phase 3 interventional study registered as NCT03592472, led by Xynomic Pharmaceuticals, and recruiting on the registry. Official title: A Randomised, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma(RENAVIV). Planned enrolment is 413 participants (estimated). The study started in 2018-07-17 and primary completion is expected in 2026-12-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT03592472","url":"https://clinicaltrials.gov/study/NCT03592472"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["abexinostat"],"companies":["xynomic-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03592472","phase":"3","setting":"A Randomized, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma(RENAVIV)","sponsor":"Xynomic Pharmaceuticals","started":"2018-07-17","startedType":"actual","enrolled":413,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05334823","kind":"trial","name":"A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents","aka":[],"tldr":"A phase 2 trial of pCAR-19B cells in acute lymphoblastic leukaemia and childhood cancers, run by Chongqing Precision Biotech Co., Ltd, now recruiting.","summary":"A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents is a phase 2 interventional study registered as NCT05334823 by Chongqing Precision Biotech Co., Ltd, with 100 participants planned, started 2022-01-26 and due to reach its primary completion in 2028-12-31. Interventions recorded: pCAR-19B cells.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05334823","url":"https://clinicaltrials.gov/study/NCT05334823"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","childhood-cancers","all-paediatric-relapsed"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["chongqing-precision-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05334823","phase":"2","setting":"A Phase II Clinical Study of Anti-CD19 CAR-T Therapy (pCAR-19B) in the Treatment of CD19-positive Relapsed/Refractory B-ALL","sponsor":"Chongqing Precision Biotech Co., Ltd","started":"2022-01-26","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05652686","kind":"trial","name":"A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)","aka":["SKYBRIDGE"],"tldr":"A phase 1/2 trial of Peluntamig, Carboplatin, Etoposide in small-cell lung cancer and prostate cancer, run by Phanes Therapeutics, now recruiting.","summary":"A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study) is a phase 1/2 interventional study registered as NCT05652686 by Phanes Therapeutics, with 203 participants planned, started 2023-09-05 and due to reach its primary completion in 2027-12. Interventions recorded: Peluntamig (PT217), Carboplatin + Etoposide, Paclitaxel., Atezolizumab, Lurbinectedin. Conditions listed: Small Cell Lung Cancer (SCLC), Large Cell Neuroendocrine Cancer (LCNEC), Neuroendocrine Prostate Cancer (NEPC), Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05652686","url":"https://clinicaltrials.gov/study/NCT05652686"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","prostate","extrapulmonary-nec"],"sections":[],"technologies":[],"targets":[],"drugs":["peluntamig","carboplatin","etoposide","paclitaxel","atezolizumab","lurbinectedin"],"companies":["phanes-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05652686","phase":"1/2","setting":"An Open-label, Multicenter, Dose Escalation, and Dose Expansion Phase 1/2 Study With Peluntamig (PT217) Followed by a Key ChemotherapY and/or Checkpoint Inhibitor ComBination in Patients With NeuRoendocrIne Carcinomas That Are Known to be DLL3 expressinG CancErs (SKYBRIDGE)","sponsor":"Phanes Therapeutics","started":"2023-09-05","startedType":"actual","enrolled":203,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06041802","kind":"trial","name":"A Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39)","aka":[],"tldr":"A phase 2 trial of Pembrolizumab in advanced solid tumours, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39) is a phase 2 interventional study registered as NCT06041802 by Merck Sharp & Dohme LLC, with 19 participants enrolled, started 2023-10-20 and due to reach its primary completion in 2028-03-31. Interventions recorded: Pembrolizumab (+) Berahyaluronidase alfa.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06041802","url":"https://clinicaltrials.gov/study/NCT06041802"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06041802","phase":"2","setting":"A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of MK-3475A in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC.","sponsor":"Merck Sharp & Dohme LLC","started":"2023-10-20","startedType":"actual","enrolled":19,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05899049","kind":"trial","name":"A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study","aka":[],"tldr":"A phase 3 trial of Pembrolizumab, Belzutifan and Lenvatinib in renal cell carcinoma, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study is a phase 3 interventional study registered as NCT05899049 by Merck Sharp & Dohme LLC, with 251 participants enrolled, started 2022-07-27 and due to reach its primary completion in 2026-02-04. Interventions recorded: Pembrolizumab, Belzutifan, Pembrolizumab/Quavonlimab and Lenvatinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05899049","url":"https://clinicaltrials.gov/study/NCT05899049"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc","clear-cell-rcc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["pembrolizumab","belzutifan","lenvatinib"],"companies":["merck","eisai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05899049","phase":"3","setting":"An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)","sponsor":"Merck Sharp & Dohme LLC","started":"2022-07-27","startedType":"actual","enrolled":251,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02332668","kind":"trial","name":"A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)","aka":["KEYNOTE-051"],"tldr":"A phase 1/2 trial of Pembrolizumab in melanoma and hodgkin lymphoma, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051) is a phase 1/2 interventional study registered as NCT02332668 by Merck Sharp & Dohme LLC, with 370 participants planned, started 2015-03-19 and due to reach its primary completion in 2028-02-02. Interventions recorded: Pembrolizumab. Conditions listed: Melanoma, Lymphoma, Solid Tumor, Classical Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02332668","url":"https://clinicaltrials.gov/study/NCT02332668"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","hodgkin-lymphoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02332668-lancet-oncol-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02332668","phase":"1/2","setting":"A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)","sponsor":"Merck Sharp & Dohme LLC","started":"2015-03-19","startedType":"actual","enrolled":370,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06623422","kind":"trial","name":"A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)","aka":["INTerpath-009"],"tldr":"A phase 3 trial of Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Gemcitabine and Intismeran autogene in non-small-cell lung cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) is a phase 3 interventional study registered as NCT06623422 by Merck Sharp & Dohme LLC, with 680 participants planned, started 2024-10-21 and due to reach its primary completion in 2033-05-16. Interventions recorded: Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Gemcitabine and Paclitaxel.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06623422","url":"https://clinicaltrials.gov/study/NCT06623422"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","neoantigen-mrna-vaccine"],"targets":[],"drugs":["pembrolizumab","cisplatin","carboplatin","pemetrexed","gemcitabine","intismeran-autogene"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06623422","phase":"3","setting":"A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)","sponsor":"Merck Sharp & Dohme LLC","started":"2024-10-21","startedType":"actual","enrolled":680,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07302347","kind":"trial","name":"A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participants With Merkel Cell Carcinoma (MK-3475-G21/KEYNOTE-G21)","aka":["KEYNOTE-G21"],"tldr":"A phase 1/2 trial of Pembrolizumab in merkel cell carcinoma and non-Hodgkin lymphoma, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participants With Merkel Cell Carcinoma (MK-3475-G21/KEYNOTE-G21) is a phase 1/2 interventional study registered as NCT07302347 by Merck Sharp & Dohme LLC, with 20 participants planned, started 2026-06-23 and due to reach its primary completion in 2029-03-30. Interventions recorded: Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07302347","url":"https://clinicaltrials.gov/study/NCT07302347"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["merkel-cell-carcinoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07302347","phase":"1/2","setting":"A Phase I/II Study of Pembrolizumab (MK-3475) in Japanese Pediatric Participants With Specific Solid Tumors or Lymphomas, or in Japanese Adult Participants With Advanced Merkel Cell Carcinoma (KEYNOTE-G21)","sponsor":"Merck Sharp & Dohme LLC","started":"2026-06-23","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06731907","kind":"trial","name":"A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-34","aka":["KEYMAKER-U01"],"tldr":"A phase 2 trial of Pembrolizumab, Carboplatin, Paclitaxel / nab-paclitaxel in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/KEYMAKER U01) is a phase 2 interventional study registered as NCT06731907 by Merck Sharp & Dohme LLC, with 90 participants planned, started 2025-03-30 and due to reach its primary completion in 2032-03-12. Interventions recorded: Pembrolizumab, Carboplatin, Paclitaxel, Nab-paclitaxel, Pemetrexed. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06731907","url":"https://clinicaltrials.gov/study/NCT06731907"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","carboplatin","paclitaxel","pemetrexed","patritumab-deruxtecan"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06731907","phase":"2","setting":"KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-03-30","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04974398","kind":"trial","name":"A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma","aka":[],"tldr":"A phase 3 trial of Penpulimab, Cisplatin, Carboplatin in nasopharyngeal carcinoma, run by Akeso, active and no longer recruiting.","summary":"A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma is a phase 3 interventional study registered as NCT04974398 by Akeso, with 296 participants enrolled, started 2021-08-16 and due to reach its primary completion in 2026-02-23. Interventions recorded: Penpulimab, placebo. Conditions listed: Nasopharyngeal Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04974398","url":"https://clinicaltrials.gov/study/NCT04974398"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nasopharyngeal","recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["penpulimab","cisplatin","carboplatin","gemcitabine"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04974398","phase":"3","setting":"A Randomized, Double-blind, Multi-center Phase III Study of Penpulimab (AK105) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma","sponsor":"Akeso","started":"2021-08-16","startedType":"actual","enrolled":296,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05023980","kind":"trial","name":"A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)","aka":["BRUIN CLL-313"],"tldr":"A phase 3 trial of Pirtobrutinib, Bendamustine and Rituximab in chronic lymphocytic leukaemia, run by Loxo Oncology, Inc., active and no longer recruiting.","summary":"A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) is a phase 3 interventional study registered as NCT05023980 by Loxo Oncology, Inc., with 309 participants enrolled, started 2021-09-23 and due to reach its primary completion in 2025-07-11. Interventions recorded: Pirtobrutinib, Bendamustine and Rituximab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05023980","url":"https://clinicaltrials.gov/study/NCT05023980"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["pirtobrutinib","bendamustine","rituximab"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05023980","phase":"3","setting":"A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","sponsor":"Loxo Oncology, Inc.","started":"2021-09-23","startedType":"actual","enrolled":309,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05254743","kind":"trial","name":"A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)","aka":["BRUIN-CLL-314"],"tldr":"A phase 3 trial of Pirtobrutinib and Ibrutinib in chronic lymphocytic leukaemia, run by Loxo Oncology, Inc., now recruiting.","summary":"A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) is a phase 3 interventional study registered as NCT05254743 by Loxo Oncology, Inc., with 737 participants planned, started 2022-07-22 and due to reach its primary completion in 2027-10. Interventions recorded: Pirtobrutinib and Ibrutinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05254743","url":"https://clinicaltrials.gov/study/NCT05254743"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["pirtobrutinib","ibrutinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05254743","phase":"3","setting":"A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)","sponsor":"Loxo Oncology, Inc.","started":"2022-07-22","startedType":"actual","enrolled":737,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06105619","kind":"trial","name":"A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).","aka":[],"tldr":"A phase 2/3 trial of Vebreltinib run by Beijing Pearl Biotechnology Limited Liability Company, active.","summary":"A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN). is a phase 2/3 interventional study registered as NCT06105619 by Beijing Pearl Biotechnology Limited Liability Company, with 84 participants enrolled, started 2018-10-08. Conditions listed: Glioblastoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06105619","url":"https://clinicaltrials.gov/study/NCT06105619"}],"tags":["ctgov-ingest"],"related":[],"cancers":["glioblastoma","idh-mutant-astrocytoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["vebreltinib"],"companies":["beijing-pearl-biotechnology-limited-liability-company"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06105619","phase":"2/3","setting":"A Randomized, Controlled, Open, Multicenter, Phase II/III Clinical Study to Evaluate the Safety and Efficacy of Vebreltinib Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).","sponsor":"Beijing Pearl Biotechnology Limited Liability Company","started":"2018-10-08","startedType":"actual","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05844150","kind":"trial","name":"A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC","aka":[],"tldr":"A phase 2 trial of PM8002 and Etoposide in small-cell lung cancer, run by Biotheus Inc., active and no longer recruiting.","summary":"A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC is a phase 2 interventional study registered as NCT05844150 by Biotheus Inc., with 50 participants enrolled, started 2023-06-01 and due to reach its primary completion in 2024-05-10. Interventions recorded: PM8002, Platinum and Etoposide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05844150","url":"https://clinicaltrials.gov/study/NCT05844150"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["pm8002","etoposide"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05844150","phase":"2","setting":"A Phase II Clinical Trial to Evaluate the Efficacy and Safety of PM8002 in Combination With Etoposide and Platinum in First-line Treatment of Extensive-Stage Small Cell Lung Cancer","sponsor":"Biotheus Inc.","started":"2023-06-01","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05879055","kind":"trial","name":"A Study of PM8002 in Combination With Chemotherapy in Patients With NEN","aka":[],"tldr":"A phase 2 trial of PM8002 in neuroendocrine tumours, run by Biotheus Inc., active and no longer recruiting.","summary":"A Study of PM8002 in Combination With Chemotherapy in Patients With NEN is a phase 2 interventional study registered as NCT05879055 by Biotheus Inc., with 31 participants enrolled, started 2023-05-17 and due to reach its primary completion in 2027-01-01. Interventions recorded: PM8002 and FOLFIRI.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05879055","url":"https://clinicaltrials.gov/study/NCT05879055"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05879055","phase":"2","setting":"A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Chemotherapy as Second Line Therapy in Unresectable Neuroendocrine Neoplasm","sponsor":"Biotheus Inc.","started":"2023-05-17","startedType":"actual","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05879068","kind":"trial","name":"A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC","aka":[],"tldr":"A phase 2 trial of PM8002 in small-cell lung cancer, run by Biotheus Inc., active and no longer recruiting.","summary":"A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC is a phase 2 interventional study registered as NCT05879068 by Biotheus Inc., with 99 participants enrolled, started 2022-05-27 and due to reach its primary completion in 2025-04-30. Interventions recorded: PM8002 and Paclitaxel.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05879068","url":"https://clinicaltrials.gov/study/NCT05879068"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05879068","phase":"2","setting":"A Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Paclitaxel Injection as Second Line Treatment for Small Cell Lung Cancer(SCLC)","sponsor":"Biotheus Inc.","started":"2022-05-27","startedType":"actual","enrolled":99,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05918133","kind":"trial","name":"A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC","aka":[],"tldr":"A phase 1/2 trial of PM8002 in triple-negative breast cancer, run by Biotheus Inc., active and no longer recruiting.","summary":"A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC is a phase 1/2 interventional study registered as NCT05918133 by Biotheus Inc., with 42 participants enrolled, started 2022-07-01 and due to reach its primary completion in 2026-10-30. Interventions recorded: PM8002 and nab-paclitaxel.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05918133","url":"https://clinicaltrials.gov/study/NCT05918133"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05918133","phase":"1/2","setting":"A Phase Ib/II Study of PM8002 Injection Plus Nab-paclitaxel as First Line Therapy for Unresectable, Locally Advanced or Metastatic Triple-negative Breast Cancer","sponsor":"Biotheus Inc.","started":"2022-07-01","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04172597","kind":"trial","name":"A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies","aka":[],"tldr":"A phase 2 trial of Poziotinib in Breast cancer and Colorectal cancer, run by Spectrum Pharmaceuticals, Inc, recorded as terminated on the registry.","summary":"A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies is a phase 2 interventional study registered as NCT04172597 by Spectrum Pharmaceuticals, Inc, with 1 participants recorded, started 2019-12-23 and due to reach its primary completion in 2022-03-29. Interventions recorded: Poziotinib Hydrochloride, Loperamide. Conditions recorded: Breast Cancer, Colorectal Cancer, Solid Tumor, Glioblastome Multiforme.\n\nLinked to the drug Poziotinib because the registry names it among its interventions and Breast cancer and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04172597","url":"https://clinicaltrials.gov/study/NCT04172597"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer","colorectal","her2-amplified-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["poziotinib"],"companies":["spectrum-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04172597","phase":"2","setting":"A Phase 2 Study of Poziotinib in Patients With EGFR or HER2 Activating Mutations in Advanced Malignancies","sponsor":"Spectrum Pharmaceuticals, Inc","started":"2019-12-23","startedType":"actual","yearReported":2024,"enrolled":1,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Cohort 5","n":1,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2024-03-13), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04172597?tab=results"}]},{"id":"proceade-crc-03","kind":"trial","name":"A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)","aka":["PROCEADE-CRC-03"],"tldr":"A phase 3 trial testing Precemtabart tocentecan in colorectal cancer, now recruiting.","summary":"A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03) is a phase 3 interventional study registered as NCT07549412, led by EMD Serono Research & Development Institute with Merck KGaA, Darmstadt, Germany, and recruiting on the registry. Official title: A Randomised, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03). Planned enrolment is 1020 participants (estimated). The study started in 2026-05-06 and primary completion is expected in 2029-10-16. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07549412","url":"https://clinicaltrials.gov/study/NCT07549412"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["precemtabart-tocentecan"],"companies":["merck-kgaa"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07549412","phase":"3","setting":"A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)","sponsor":"EMD Serono Research & Development Institute","started":"2026-05-06","startedType":"actual","enrolled":1020,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06914128","kind":"trial","name":"A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of BAY 3713372 in advanced solid tumours, run by Bayer, now recruiting.","summary":"A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors is a phase 1/2 interventional study registered as NCT06914128 by Bayer, with 450 participants planned, started 2025-03-21 and due to reach its primary completion in 2029-06-18. Interventions recorded: BAY 3713372.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06914128","url":"https://clinicaltrials.gov/study/NCT06914128"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06914128","phase":"1/2","setting":"A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of BAY 3713372, a Novel 2nd Generation PRMT5 Inhibitor, in Participants With MTAP-deleted Solid Tumors.","sponsor":"Bayer","started":"2025-03-21","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03812874","kind":"trial","name":"A Study of PTX-9908 Injection for Non-resectable HCC with TACE","aka":[],"tldr":"A phase 1/2 trial of PTX-9908 Injection in hepatocellular carcinoma, run by TCM Biotech International Corp., now recruiting.","summary":"A Study of PTX-9908 Injection for Non-resectable HCC with TACE is a phase 1/2 interventional study registered as NCT03812874 by TCM Biotech International Corp., with 50 participants planned, started 2020-10-06 and due to reach its primary completion in 2026-08-30. Interventions recorded: PTX-9908 Injection and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03812874","url":"https://clinicaltrials.gov/study/NCT03812874"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-intermediate"],"sections":[],"technologies":["tace"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03812874","phase":"1/2","setting":"Phase I/II Study of PTX-9908 Injection As an Inhibitor of Cancer Progression in Patients with Non-resectable Hepatocellular Carcinoma Following Transarterial Chemoembolization Treatment","sponsor":"TCM Biotech International Corp.","started":"2020-10-06","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05487391","kind":"trial","name":"A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection","aka":[],"tldr":"A phase 3 trial testing QL1706 in non-small-cell lung cancer, now recruiting.","summary":"A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection is a phase 3 interventional study registered as NCT05487391, led by Qilu Pharmaceutical, and recruiting on the registry. Official title: QL1706 Combined With Platinum-based Chemotherapy Versus Placebo Combined With Platinum-based Chemotherapy as Adjuvant Therapy for Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection: a Randomised, Double-blind, Multicenter Phase III Clinical Study. Planned enrolment is 632 participants (estimated). The study started in 2022-12-08 and primary completion is expected in 2027-08-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05487391","url":"https://clinicaltrials.gov/study/NCT05487391"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ql1706"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05487391","phase":"3","setting":"QL1706 Combined With Platinum-based Chemotherapy Versus Placebo Combined With Platinum-based Chemotherapy as Adjuvant Therapy for Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection: a Randomized, Double-blind, Multicenter Phase III Clinical Study","sponsor":"Qilu Pharmaceutical","started":"2022-12-08","startedType":"actual","enrolled":632,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05690945","kind":"trial","name":"A Study of QL1706 in Combination With Chemotherapy in PD-L1-Negative Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial testing QL1706 in non-small-cell lung cancer, active and no longer recruiting.","summary":"A Study of QL1706 in Combination With Chemotherapy in PD-L1-Negative Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT05690945, led by Qilu Pharmaceutical, and active but no longer recruiting on the registry. Official title: A Randomised, Double-blind, Multicenter Phase 3 Clinical Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Chemotherapy in First-line PD-L1 Negative, Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients. Planned enrolment is 606 participants (actual). The study started in 2023-02-15 and primary completion is expected in 2029-06. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05690945","url":"https://clinicaltrials.gov/study/NCT05690945"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ql1706"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05690945","phase":"3","setting":"A Randomized, Double-blind, Multicenter Phase 3 Clinical Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Chemotherapy in First-line PD-L1 Negative, Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients","sponsor":"Qilu Pharmaceutical","started":"2023-02-15","startedType":"actual","enrolled":606,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06789796","kind":"trial","name":"a Study of QL1706 or QL1604 in Patients With Limited-stage Small Cell Lung Cancer After Chemoradiotherapy","aka":[],"tldr":"A phase 3 trial of Iparomlimab and tuvonralimab in Small-cell lung cancer, run by Qilu Pharmaceutical Co., Ltd., not yet recruiting.","summary":"a Study of QL1706 or QL1604 in Patients With Limited-stage Small Cell Lung Cancer After Chemoradiotherapy is a phase 3 interventional study registered as NCT06789796 by Qilu Pharmaceutical Co., Ltd., with 636 participants planned, started 2025-02 and due to reach its primary completion in 2028-03. Interventions recorded: Iparomlimab and Tuvonralimab (QL1706), placebo for QL1604, QL1604, placebo for Iparomlimab and Tuvonralimab (QL1706). Conditions recorded: Small-cell Lung Cancer.\n\nLinked to the drug Iparomlimab and tuvonralimab because the registry names it among its interventions and Small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06789796","url":"https://clinicaltrials.gov/study/NCT06789796"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","limited-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["iparomlimab-tuvonralimab"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06789796","phase":"3","setting":"A Randomized, Double-blind Phase III Clinical Study of QL1706 Versus QL1604 as Consolidation Treatment in Patients With Limited-stage Small Cell Lung Cancer Who Have Not Experienced Disease Progression After Concurrent or Sequential Chemoradiotherapy.","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2025-02","startedType":"estimated","enrolled":636,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07256782","kind":"trial","name":"A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of QLC5508, QL1706, Carboplatin, Cisplatin, QL2107 and Fluorouracil (5-FU) in advanced solid tumours, run by Qilu Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07256782 by Qilu Pharmaceutical Co., Ltd., with 444 participants planned, started 2025-10-24 and due to reach its primary completion in 2026-10. Interventions recorded: QLC5508, QL1706, Cisplatin/ Carboplatin, QL2107, Paclitaxel and 5-fluorouracil (5-FU).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07256782","url":"https://clinicaltrials.gov/study/NCT07256782"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["qlc5508","ql1706","carboplatin","cisplatin","ql2107","fluorouracil"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07256782","phase":"1/2","setting":"A Phase Ib/II, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administration of QLC5508 in Combination With Other Anti-tumor Agents in Patients With Advanced Solid Tumors","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2025-10-24","startedType":"actual","enrolled":444,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06911827","kind":"trial","name":"A Study of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients","aka":[],"tldr":"A phase 1/2 trial of QL2107 in advanced solid tumours, run by Qilu Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients is a phase 1/2 interventional study registered as NCT06911827 by Qilu Pharmaceutical Co., Ltd., with 149 participants planned, started 2025-05-09 and due to reach its primary completion in 2027-12. Interventions recorded: QLP2117 and QL2107.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06911827","url":"https://clinicaltrials.gov/study/NCT06911827"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ql2107"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06911827","phase":"1/2","setting":"A Phase Ib/II Open-Label, Dose-Escalation and Dose-expansion Clinical Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2025-05-09","startedType":"actual","enrolled":149,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04683679","kind":"trial","name":"A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negat","aka":[],"tldr":"A phase 2 trial of pembrolizumab and olaparib in triple-negative breast cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer is a phase 2, interventional study registered as NCT04683679 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 34 participants, started 2021-04-21 and due to reach its primary completion in 2027-01. Interventions recorded: Pembrolizumab; Olaparib; Radiation. Conditions listed: Triple Negative Breast Cancer; TNBC - Triple-Negative Breast Cancer; Breast Cancer; Metastatic Breast Cancer. Triple-negative eligibility wording from the registry: \"* Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of triple negative breast cancer or ER+/Her2 will be enrolled in this study\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04683679","url":"https://clinicaltrials.gov/study/NCT04683679"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["pembrolizumab","olaparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04683679","phase":"2","setting":"Phase II Study of Pembrolizumab and Ablative Radiotherapy With or Without Olaparib in Metastatic Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancers : Initial Test Cohorts of a Platform Trial to Sequentially Investigate Immunotherapy Combinations for the Augmentation of Immune Responses","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2021-04-21","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06504147","kind":"trial","name":"A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery","aka":[],"tldr":"A phase 2 trial of Radspherin in ovarian cancer, run by Oncoinvent Solutions AS, now recruiting.","summary":"A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery is a phase 2 interventional study registered as NCT06504147 by Oncoinvent Solutions AS, with 114 participants planned, started 2024-06-15 and due to reach its primary completion in 2028-02-29. Interventions recorded: Radspherin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06504147","url":"https://clinicaltrials.gov/study/NCT06504147"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06504147","phase":"2","setting":"A Phase 2, Randomised, Open Label, Multicentre Study of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Patients With Primary Advanced High-grade Serous or High-grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient and Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery","sponsor":"Oncoinvent Solutions AS","started":"2024-06-15","startedType":"actual","enrolled":114,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06864169","kind":"trial","name":"A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)","aka":["REJOICE-GI01"],"tldr":"A phase 2 trial of Raludotatug deruxtecan in advanced solid tumours, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005) is a phase 2 interventional study registered as NCT06864169 by Merck Sharp & Dohme LLC, with 160 participants enrolled, started 2025-04-01 and due to reach its primary completion in 2026-08-18. Interventions recorded: Raludotatug Deruxtecan (R-DXd).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06864169","url":"https://clinicaltrials.gov/study/NCT06864169"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["raludotatug-deruxtecan"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06864169","phase":"2","setting":"A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers","sponsor":"Merck Sharp & Dohme LLC","started":"2025-04-01","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06660654","kind":"trial","name":"A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)","aka":["REJOICE-PanTumor01"],"tldr":"A phase 2 trial of Raludotatug deruxtecan in advanced solid tumours, run by Daiichi Sankyo, active and no longer recruiting.","summary":"A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01) is a phase 2 interventional study registered as NCT06660654 by Daiichi Sankyo, with 200 participants enrolled, started 2025-01-06 and due to reach its primary completion in 2027-09-30. Interventions recorded: Raludotatug deruxtecan.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06660654","url":"https://clinicaltrials.gov/study/NCT06660654"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["raludotatug-deruxtecan"],"companies":["daiichi-sankyo","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06660654","phase":"2","setting":"REJOICE-PanTumor01: A Phase 2, Multicenter, Open-Label, Pan-Tumor Trial to Evaluate Efficacy and Safety of Raludotatug Deruxtecan (R-DXd) in Participants With Advanced/Metastatic Solid Tumors","sponsor":"Daiichi Sankyo","started":"2025-01-06","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02411448","kind":"trial","name":"A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RE","aka":["RELAY"],"tldr":"A phase 3 trial of Ramucirumab, Erlotinib, Gefitinib in non-small-cell lung cancer and small-cell lung cancer, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) is a phase 3 interventional study registered as NCT02411448 by Eli Lilly and Company, with 545 participants enrolled, started 2015-05-06 and due to reach its primary completion in 2019-01-23. Interventions recorded: Ramucirumab, Placebo, Erlotinib, Gefitinib, Osimertinib. Conditions listed: Metastatic Non-Small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2020; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02411448","url":"https://clinicaltrials.gov/study/NCT02411448"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["ramucirumab","erlotinib","gefitinib","osimertinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02411448-lancet-oncol-2019","paper-nct02411448-j-thorac-oncol-2025-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02411448","phase":"3","setting":"A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination With Ramucirumab or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer","sponsor":"Eli Lilly and Company","started":"2015-05-06","startedType":"actual","yearReported":2020,"enrolled":545,"enrolledBasis":"registry","outcomes":[{"endpoint":"Part B: Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Part B: Ramucirumab+ Erlotinib","n":224,"value":19.4,"note":"95% CI 15.4 to 21.6; Figures from the ClinicalTrials.gov results section (first posted 2020-03-04), not from a publication"},{"name":"Part B: Placebo+ Erlotinib","n":225,"value":12.4,"note":"95% CI 11.0 to 13.5"}],"hr":0.591,"ci":[0.461,0.76],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT02411448?tab=results"},{"endpoint":"Part B: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])","unit":"%","arms":[{"name":"Part B: Ramucirumab+ Erlotinib","n":224,"value":76.3,"note":"95% CI 70.8 to 81.9; Figures from the ClinicalTrials.gov results section (first posted 2020-03-04), not from a publication"},{"name":"Part B: Placebo+ Erlotinib","n":225,"value":74.7,"note":"95% CI 69.0 to 80.3"}],"p":"0.7413","source":"https://clinicaltrials.gov/study/NCT02411448?tab=results"}]},{"id":"nct02711553","kind":"trial","name":"A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of Ramucirumab, Cisplatin, Gemcitabine in metastatic cancer, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer is a phase 2 interventional study registered as NCT02711553 by Eli Lilly and Company, with 309 participants enrolled, started 2016-05-19 and due to reach its primary completion in 2018-02-16. Interventions recorded: Ramucirumab, Merestinib, Cisplatin, Gemcitabine, Placebo Oral. Conditions listed: Biliary Tract Cancer, Metastatic Cancer, Advanced Cancer. Results were posted on ClinicalTrials.gov in 2021; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02711553","url":"https://clinicaltrials.gov/study/NCT02711553"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["ramucirumab","cisplatin","gemcitabine","merestinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02711553","phase":"2","setting":"Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo Plus Cisplatin and Gemcitabine as First-Line Treatment in Patients With Advanced or Metastatic Biliary Tract Cancer","sponsor":"Eli Lilly and Company","started":"2016-05-19","startedType":"actual","yearReported":2021,"enrolled":309,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine","n":106,"value":6.47,"note":"IQR 3.68 to 8.51; Figures from the ClinicalTrials.gov results section (first posted 2021-02-26), not from a publication"},{"name":"80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine","n":102,"value":6.97,"note":"IQR 4.34 to 9.79"},{"name":"Pooled Placebo","n":101,"value":6.64,"note":"IQR 4.11 to 9.72"}],"source":"https://clinicaltrials.gov/study/NCT02711553?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine","n":106,"value":10.45,"note":"IQR 8.48 to 11.76; Figures from the ClinicalTrials.gov results section (first posted 2021-02-26), not from a publication"},{"name":"80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine","n":102,"value":14.03,"note":"IQR 11.96 to 16.36"},{"name":"Pooled Placebo","n":101,"value":13.04,"note":"IQR 11.40 to 15.31"}],"source":"https://clinicaltrials.gov/study/NCT02711553?tab=results"},{"endpoint":"Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)","unit":"%","arms":[{"name":"8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine","n":106,"value":31.1,"note":"95% CI 22.3 to 39.9; Figures from the ClinicalTrials.gov results section (first posted 2021-02-26), not from a publication"},{"name":"80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine","n":102,"value":19.6,"note":"95% CI 11.9 to 27.3"},{"name":"Pooled Placebo","n":101,"value":32.7,"note":"95% CI 23.5 to 41.8"}],"source":"https://clinicaltrials.gov/study/NCT02711553?tab=results"}]},{"id":"nct05205850","kind":"trial","name":"A Study of RC118 in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of RC118-ADC in advanced solid tumours, run by RemeGen Co., Ltd., now recruiting.","summary":"A Study of RC118 in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors is a phase 1/2 interventional study registered as NCT05205850 by RemeGen Co., Ltd., with 135 participants planned, started 2022-03-03 and due to reach its primary completion in 2025-09-30. Interventions recorded: RC118-ADC.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05205850","url":"https://clinicaltrials.gov/study/NCT05205850"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["rc118-adc"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05205850","phase":"1/2","setting":"An Open, Multi-center Phase I/IIa Clinical Study of RC118 for Injection in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors with Positive Expression of Claudin 18.2","sponsor":"RemeGen Co., Ltd.","started":"2022-03-03","startedType":"actual","enrolled":135,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06038396","kind":"trial","name":"A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of RC118-ADC, Toripalimab and RC148 in advanced solid tumours, run by RemeGen Co., Ltd., now recruiting.","summary":"A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06038396 by RemeGen Co., Ltd., with 48 participants planned, started 2023-08-03 and due to reach its primary completion in 2026-02-28. Interventions recorded: RC118, Toripalimab and RC148.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06038396","url":"https://clinicaltrials.gov/study/NCT06038396"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["rc118-adc","toripalimab","rc148"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06038396","phase":"1/2","setting":"A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC118 in Combination with Toripalimab / RC148 for Patients with Claudin 18.2-Positive, Locally Advanced Unresectable or Metastatic Malignant Solid Tumors","sponsor":"RemeGen Co., Ltd.","started":"2023-08-03","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06016062","kind":"trial","name":"A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Docetaxel and Bevacizumab in advanced solid tumours, run by RemeGen Co., Ltd., now recruiting.","summary":"A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors is a phase 1/2 interventional study registered as NCT06016062 by RemeGen Co., Ltd., with 221 participants planned, started 2023-09-14 and due to reach its primary completion in 2025-12-31. Interventions recorded: RC148 Monotherapy, RC148+docetaxel Combination Therapy, RC148+RC48 Combination Therapy, RC148+RC88 Combination Therapy and RC148/Bevacizumab+RC88 Combination Therapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06016062","url":"https://clinicaltrials.gov/study/NCT06016062"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["docetaxel","bevacizumab"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06016062","phase":"1/2","setting":"A Multi-center Phase I/II Trial to Evaluate the Efficacy and Safety of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors","sponsor":"RemeGen Co., Ltd.","started":"2023-09-14","startedType":"actual","enrolled":221,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05980481","kind":"trial","name":"A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer","aka":[],"tldr":"A phase 2/3 trial of Trastuzumab, Toripalimab, Oxaliplatin and Capecitabine in gastric & gastro-oesophageal junction cancer, run by RemeGen Co., Ltd., active and no longer recruiting.","summary":"A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer is a phase 2/3 interventional study registered as NCT05980481 by RemeGen Co., Ltd., with 201 participants enrolled, started 2023-08-04 and due to reach its primary completion in 2025-07-10. Interventions recorded: RC48-ADC（2.5mg/kg）, Trastuzumab, Toripalimab, Oxaliplatin（130mg/m2 ）, Capecitabine（1000mg/m2） and RC48-ADC（2.0mg/kg）.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05980481","url":"https://clinicaltrials.gov/study/NCT05980481"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["trastuzumab","toripalimab","oxaliplatin","capecitabine"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05980481","phase":"2/3","setting":"A Study of RC48-ADC Combine With Toripalimab and Chemotherapy or RC48-ADC Combine With Toripalimab and Trastuzumab as First-line Treatment in Local Advanced or Metastatic Gastric Cancer With the HER2 Expression or Non-expression","sponsor":"RemeGen Co., Ltd.","started":"2023-08-04","startedType":"actual","enrolled":201,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06155396","kind":"trial","name":"A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent o","aka":[],"tldr":"A phase 2 trial of Disitamab vedotin, Zimberelimab in cervical cancer, run by RemeGen Co., Ltd., now recruiting.","summary":"A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent or Metastatic Cervical Cancer is a phase 2 interventional study registered as NCT06155396 by RemeGen Co., Ltd., with 116 participants planned, started 2024-01-11 and due to reach its primary completion in 2027-06-30. Interventions recorded: Disitamab Vedotin, Zimberelimab. Conditions listed: Cervical Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06155396","url":"https://clinicaltrials.gov/study/NCT06155396"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["disitamab-vedotin","zimberelimab"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06155396","phase":"2","setting":"A Single-Arm, Open- Label, Multicenter Phase II Study of RC48-ADC in Combination With Zimberelimab Injection for the Treatment ,at Least First-line Platinum-containing Standard Therapy Failed in HER2-expressing Subject With Recurrent or Metastatic Cervical Cancer","sponsor":"RemeGen Co., Ltd.","started":"2024-01-11","startedType":"actual","enrolled":116,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05745740","kind":"trial","name":"A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation","aka":[],"tldr":"A phase 1/2 trial of pyrotinib in lung cancer, run by RemeGen Co., Ltd., not yet recruiting.","summary":"A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation is a phase 1/2, interventional study registered as NCT05745740 by RemeGen Co., Ltd., with a registry enrolment figure of 26 participants, started 2027-12-01 and due to reach its primary completion in 2027-12-01. Interventions recorded: RC48-ADC; Pyrotinib. Conditions listed: Non-small Cell Lung Cancer. Primary outcome: maximal tolerance dose (MTD) of RC48-ADC combined with Pyrotinib. Lung eligibility wording from the registry: \"* According to UICC/AJCC 8th Edition, histologically and/or cytologically-confirmed, cannot be surgically removed, locally advanced or metastatic NSCLC\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05745740","url":"https://clinicaltrials.gov/study/NCT05745740"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["her2-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pyrotinib"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05745740","phase":"1/2","setting":"An Open-label, Single-center, Phase Ib/II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of RC48-ADC Combined With Pyrotinib in Local Advanced or Metastasis NSCLC With HER2 Mutation","sponsor":"RemeGen Co., Ltd.","started":"2027-12-01","startedType":"estimated","enrolled":26,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05302284","kind":"trial","name":"A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma","aka":[],"tldr":"A phase 3 trial of Toripalimab, Gemcitabine, Cisplatin and Carboplatin in bladder & urothelial cancer, run by RemeGen Co., Ltd., now recruiting.","summary":"A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma is a phase 3 interventional study registered as NCT05302284 by RemeGen Co., Ltd., with 452 participants planned, started 2022-06-14 and due to reach its primary completion in 2026-12-31. Interventions recorded: RC48-ADC, Toripalimab, Gemcitabine, Cisplatin and Carboplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05302284","url":"https://clinicaltrials.gov/study/NCT05302284"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab","gemcitabine","cisplatin","carboplatin"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05302284","phase":"3","setting":"A Open-Label, Multicenter, Randomised, Controlled Phase 3 Study of RC48-ADC Plus Toripalimab Versus Chemotherapy Alone in Previously Untreated Unresectable Locally Advanced or Metastatic Urothelial Carcinoma With HER2-Expressing","sponsor":"RemeGen Co., Ltd.","started":"2022-06-14","startedType":"actual","enrolled":452,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06678659","kind":"trial","name":"A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer","aka":["DAHLIA"],"tldr":"A phase 1/2 trial of REC-1245 in non-Hodgkin lymphoma, run by Recursion Pharmaceuticals Inc., now recruiting.","summary":"A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer is a phase 1/2 interventional study registered as NCT06678659 by Recursion Pharmaceuticals Inc., with 170 participants planned, started 2024-11-21 and due to reach its primary completion in 2028-10-30. Interventions recorded: REC-1245.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06678659","url":"https://clinicaltrials.gov/study/NCT06678659"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["recursion"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06678659","phase":"1/2","setting":"A Phase 1 / 2, Open-Label Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer","sponsor":"Recursion Pharmaceuticals Inc.","started":"2024-11-21","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04077099","kind":"trial","name":"A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of REGN5093 in non-small-cell lung cancer, run by Regeneron Pharmaceuticals, active and no longer recruiting.","summary":"A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT04077099 by Regeneron Pharmaceuticals, with 95 participants enrolled, started 2020-01-07 and due to reach its primary completion in 2027-07-06. Interventions recorded: REGN5093.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04077099","url":"https://clinicaltrials.gov/study/NCT04077099"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","met-altered-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04077099","phase":"1/2","setting":"A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer","sponsor":"Regeneron Pharmaceuticals","started":"2020-01-07","startedType":"actual","enrolled":95,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03093116","kind":"trial","name":"A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements","aka":["TRIDENT-1"],"tldr":"A phase 1/2 trial of Repotrectinib in advanced solid tumours, run by Turning Point Therapeutics, Inc., now recruiting.","summary":"A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements is a phase 1/2 interventional study registered as NCT03093116 by Turning Point Therapeutics, Inc., with 500 participants planned, started 2017-03-07 and due to reach its primary completion in 2028-02-29. Interventions recorded: Oral repotrectinib (TPX-0005).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03093116","url":"https://clinicaltrials.gov/study/NCT03093116"},{"label":"TRIDENT-1 (New England Journal of Medicine 2024)","url":"https://doi.org/10.1056/NEJMoa2302299"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","ros1-positive-nsclc","ntrk-fusion-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["repotrectinib"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":["profile-1001-ros1","nct02568267"],"people":[],"bottlenecks":[],"keyPapers":["paper-trident-1-repotrectinib-nejm-2024"],"journals":[],"dependsOn":[],"notes":["In the registrational phase 1-2 TRIDENT-1 trial, the recommended dose was 160 mg daily for 14 days then 160 mg twice daily. Response occurred in 56 of 71 ROS1 inhibitor-naive patients with ROS1 fusion-positive non-small-cell lung cancer (79 percent, 95 percent confidence interval 68 to 88), with median duration of response 34.1 months and median progression-free survival 35.7 months; in 21 of 56 patients who had had one ROS1 inhibitor and no chemotherapy (38 percent, 25 to 52), median duration of response was 14.8 months and progression-free survival 9.0 months; and in 10 of 17 patients with ROS1 G2032R (59 percent, 33 to 82). Among 426 patients treated at the phase 2 dose the commonest treatment-related events were dizziness (58 percent), dysgeusia (50 percent) and paraesthesia (30 percent), with 3 percent discontinuing (New England Journal of Medicine 2024)."],"nct":"NCT03093116","phase":"1/2","setting":"A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)","sponsor":"Turning Point Therapeutics, Inc.","result":"Repotrectinib produced responses in 79 percent of ROS1 inhibitor-naive patients (median progression-free survival 35.7 months) and 38 percent after one ROS1 inhibitor, including 59 percent of those with the G2032R solvent-front mutation.","started":"2017-03-07","startedType":"actual","yearReported":2024,"enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04094610","kind":"trial","name":"A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations","aka":[],"tldr":"A phase 1/2 trial of Repotrectinib in non-Hodgkin lymphoma and brain and spinal cord tumours, run by Turning Point Therapeutics, Inc., now recruiting.","summary":"A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations is a phase 1/2 interventional study registered as NCT04094610 by Turning Point Therapeutics, Inc., with 75 participants planned, started 2020-03-12 and due to reach its primary completion in 2026-09-30. Interventions recorded: Oral repotrectinib (TPX-0005).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04094610","url":"https://clinicaltrials.gov/study/NCT04094610"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","brain-tumours"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["repotrectinib"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04094610","phase":"1/2","setting":"A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations","sponsor":"Turning Point Therapeutics, Inc.","started":"2020-03-12","startedType":"actual","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06140836","kind":"trial","name":"A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)","aka":["TRIDENT-3"],"tldr":"A phase 3 trial of Repotrectinib and Crizotinib in non-small-cell lung cancer, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) is a phase 3 interventional study registered as NCT06140836 by Bristol-Myers Squibb, with 190 participants enrolled, started 2023-12-21 and due to reach its primary completion in 2026-03-13. Interventions recorded: Repotrectinib and Crizotinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06140836","url":"https://clinicaltrials.gov/study/NCT06140836"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","ros1-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["repotrectinib","crizotinib"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06140836","phase":"3","setting":"Randomized, Open-label, Multicenter, Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)","sponsor":"Bristol-Myers Squibb","started":"2023-12-21","startedType":"actual","enrolled":190,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07221253","kind":"trial","name":"A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)","aka":["ARTEMIDE-Biliary02"],"tldr":"A phase 3 trial of Rilvegostomig, Durvalumab and Gemcitabine + cisplatin in biliary tract cancer, run by AstraZeneca, now recruiting.","summary":"A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) is a phase 3 interventional study registered as NCT07221253 by AstraZeneca, with 1100 participants planned, started 2025-12-04 and due to reach its primary completion in 2029-07-31. Interventions recorded: Rilvegostomig, Durvalumab and Gemcitabine/Cisplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07221253","url":"https://clinicaltrials.gov/study/NCT07221253"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["rilvegostomig","durvalumab","gemcitabine-cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07221253","phase":"3","setting":"Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)","sponsor":"AstraZeneca","started":"2025-12-04","startedType":"actual","enrolled":1100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03673501","kind":"trial","name":"A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib","aka":["INTRIGUE"],"tldr":"A phase 3 trial of Ripretinib and Sunitinib in gastrointestinal stromal tumour, run by Deciphera Pharmaceuticals, LLC, active and no longer recruiting.","summary":"A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib is a phase 3 interventional study registered as NCT03673501 by Deciphera Pharmaceuticals, LLC, with 453 participants enrolled, started 2019-02-08 and due to reach its primary completion in 2021-09-01. Interventions recorded: Ripretinib and Sunitinib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03673501","url":"https://clinicaltrials.gov/study/NCT03673501"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gist","gist-imatinib-resistant"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["ripretinib","sunitinib"],"companies":["deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03673501","phase":"3","setting":"A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of Ripretinib vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) After Treatment With Imatinib","sponsor":"Deciphera Pharmaceuticals, LLC","started":"2019-02-08","startedType":"actual","yearReported":2024,"enrolled":453,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population","primary":true,"unit":"months","arms":[{"name":"Ripretinib","n":163,"value":8.3,"note":"95% CI 6.8 to 13.3; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication"},{"name":"Sunitinib","n":164,"value":7,"note":"95% CI 5.6 to 10.9"}],"hr":0.88,"ci":[0.66,1.16],"p":"0.3598","source":"https://clinicaltrials.gov/study/NCT03673501?tab=results"},{"endpoint":"Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population","primary":true,"unit":"months","arms":[{"name":"Ripretinib","n":226,"value":8,"note":"95% CI 6.5 to 10.8; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication"},{"name":"Sunitinib","n":227,"value":8.3,"note":"95% CI 6.3 to 11.0"}],"hr":1.05,"ci":[0.82,1.33],"p":"0.7153","source":"https://clinicaltrials.gov/study/NCT03673501?tab=results"},{"endpoint":"Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population","unit":"months","arms":[{"name":"Ripretinib","n":163,"value":34,"note":"95% CI 29.3 to NA; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication"},{"name":"Sunitinib","n":164,"value":31.5,"note":"95% CI 29.4 to NA"}],"hr":1.05,"ci":[0.75,1.48],"p":"0.7733","source":"https://clinicaltrials.gov/study/NCT03673501?tab=results"},{"endpoint":"Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population","unit":"%","arms":[{"name":"Ripretinib","n":163,"value":23.9,"note":"95% CI 17.6 to 31.2; Figures from the ClinicalTrials.gov results section (first posted 2024-01-02), not from a publication"},{"name":"Sunitinib","n":164,"value":14.6,"note":"95% CI 9.6 to 21.0"}],"p":"0.0333","source":"https://clinicaltrials.gov/study/NCT03673501?tab=results"}]},{"id":"nct07602855","kind":"trial","name":"A Study of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors (EMBOLD PanTumour-103)","aka":["EMBOLD PanTumour-103"],"tldr":"A phase 1/2 trial of ivonescimab in lung cancer, run by GlaxoSmithKline, now recruiting.","summary":"A Study of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors (EMBOLD PanTumour-103) is a phase 1/2, interventional study registered as NCT07602855 by GlaxoSmithKline, with a registry enrolment figure of 184 participants, started 2026-09-09 and due to reach its primary completion in 2029-06-22. Interventions recorded: Risvutatug rezetecan; Ivonescimab. Conditions listed: Neoplasms, Lung. Primary outcome: Phase 1 and Phase 2 Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs); Phase 1 and Phase 2: Number of participants with AEs leading to dose modifications including study intervention discontinuation; Phase 2: Number of part. Lung eligibility wording from the registry: \"ES-SCLC\". Sites: Japan, United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07602855","url":"https://clinicaltrials.gov/study/NCT07602855"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":["antiangiogenic","bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07602855","phase":"1/2","setting":"A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors","sponsor":"GlaxoSmithKline","started":"2026-09-09","startedType":"actual","enrolled":184,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04442022","kind":"trial","name":"A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Ly","aka":[],"tldr":"A phase 2/3 trial of Selinexor, Rituximab, Gemcitabine in diffuse large b-cell lymphoma, run by Karyopharm Therapeutics Inc, active and no longer recruiting.","summary":"A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma is a phase 2/3 interventional study registered as NCT04442022 by Karyopharm Therapeutics Inc, with 501 participants planned, started 2020-09-03 and due to reach its primary completion in 2026-12. Interventions recorded: Selinexor (combination therapy), Selinexor (combination therapy), Selinexor (combination therapy), Placebo matching for Selinexor (combination therapy), Rituximab (combination therapy). Conditions listed: Relapsed/Refractory Diffuse Large B-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04442022","url":"https://clinicaltrials.gov/study/NCT04442022"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["antiemetic-therapy","cytotoxic-chemotherapy","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["selinexor","rituximab","gemcitabine","dexamethasone","cisplatin"],"companies":["karyopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04442022","phase":"2/3","setting":"A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)","sponsor":"Karyopharm Therapeutics Inc","started":"2020-09-03","startedType":"actual","enrolled":501,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05487170","kind":"trial","name":"A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)","aka":["CHAMP-1"],"tldr":"A phase 1/2 trial of RNK05047 in advanced solid tumours, run by Ranok Therapeutics (Hangzhou) Co., Ltd., now recruiting.","summary":"A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1) is a phase 1/2 interventional study registered as NCT05487170 by Ranok Therapeutics (Hangzhou) Co., Ltd., with 32 participants planned, started 2022-07-12 and due to reach its primary completion in 2025-06-01. Interventions recorded: RNK05047.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05487170","url":"https://clinicaltrials.gov/study/NCT05487170"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["rnk05047"],"companies":["ranok-therapeutics-hangzhou"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05487170","phase":"1/2","setting":"A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Chaperone-mediated Protein Degrader RNK05047 in Subjects With Advanced Solid Tumors (CHAMP-1)","sponsor":"Ranok Therapeutics (Hangzhou) Co., Ltd.","started":"2022-07-12","startedType":"actual","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06667544","kind":"trial","name":"A Study of RNK08954 in Subjects With Advanced Solid Tumors With KRAS ((Kirsten Rat Sarcoma) G12D Mutation","aka":["TRIAD1"],"tldr":"A phase 1/2 trial of RNK08954-01 in sarcomas, run by Ranok Therapeutics (Hangzhou) Co., Ltd., now recruiting.","summary":"A Study of RNK08954 in Subjects With Advanced Solid Tumors With KRAS ((Kirsten Rat Sarcoma) G12D Mutation is a phase 1/2 interventional study registered as NCT06667544 by Ranok Therapeutics (Hangzhou) Co., Ltd., with 152 participants planned, started 2024-11-08 and due to reach its primary completion in 2026-12. Interventions recorded: RNK08954-01.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06667544","url":"https://clinicaltrials.gov/study/NCT06667544"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":[],"targets":["kras"],"drugs":[],"companies":["ranok-therapeutics-hangzhou"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06667544","phase":"1/2","setting":"A Phase 1/2, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of RNK08954 in Patients With Advanced Solid Tumors With a KRAS G12D Mutation TRIAD1 (Trial of RNK08954 In KRAS G12D Mutation)","sponsor":"Ranok Therapeutics (Hangzhou) Co., Ltd.","started":"2024-11-08","startedType":"actual","enrolled":152,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07609862","kind":"trial","name":"A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies","aka":[],"tldr":"A phase 1/2 trial of Rocbrutinib in mantle cell lymphoma and diffuse large b-cell lymphoma, run by Guangzhou Lupeng Pharmaceutical Company LTD., now recruiting.","summary":"A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies is a phase 1/2 interventional study registered as NCT07609862 by Guangzhou Lupeng Pharmaceutical Company LTD., with 92 participants planned, started 2026-07-14 and due to reach its primary completion in 2029-06-30. Interventions recorded: Lacutoclax+Rocbrutinib. Conditions listed: Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma ( FL), Waldenström Macroglobulinemia (WM). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07609862","url":"https://clinicaltrials.gov/study/NCT07609862"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma","dlbcl","follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["rocbrutinib"],"companies":["lupeng-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07609862","phase":"1/2","setting":"A Phase Ib/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTK Inhibitor Rocbrutinib in Combination With BCL-2 Inhibitor Lacutoclax in Patients With B-Cell Malignancies","sponsor":"Guangzhou Lupeng Pharmaceutical Company LTD.","started":"2026-07-14","startedType":"actual","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05716087","kind":"trial","name":"A Study of Rocbrutinib in Participants With Relapse or Refractory Mantle Cell Lymphoma","aka":[],"tldr":"A phase 2 trial of Rocbrutinib in mantle cell lymphoma, run by Guangzhou Lupeng Pharmaceutical Company LTD., active and no longer recruiting.","summary":"A Study of Rocbrutinib in Participants With Relapse or Refractory Mantle Cell Lymphoma is a phase 2 interventional study registered as NCT05716087 by Guangzhou Lupeng Pharmaceutical Company LTD., with 62 participants planned, started 2023-02-21 and due to reach its primary completion in 2024-12-05. Interventions recorded: Rocbrutinib. Conditions listed: Mantle Cell Lymphoma (MCL). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05716087","url":"https://clinicaltrials.gov/study/NCT05716087"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["rocbrutinib"],"companies":["lupeng-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05716087","phase":"2","setting":"An Open Label, Single Arm, Multicenter Phase II Study of the Efficacy and Safety of Rocbrutinib Monotherapy for Recurrent or Refractory Mantle Cell Lymphoma","sponsor":"Guangzhou Lupeng Pharmaceutical Company LTD.","started":"2023-02-21","startedType":"actual","enrolled":62,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07189065","kind":"trial","name":"A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma","aka":[],"tldr":"A phase 2 trial of Rocbrutinib, Bendamustine, Rituximab in diffuse large b-cell lymphoma, run by Guangzhou Lupeng Pharmaceutical Company LTD., now recruiting.","summary":"A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma is a phase 2 interventional study registered as NCT07189065 by Guangzhou Lupeng Pharmaceutical Company LTD., with 150 participants planned, started 2025-11-27 and due to reach its primary completion in 2027-12-31. Interventions recorded: Rocbrutinib, Bendamustine, Rituximab, Lenalidomide. Conditions listed: Diffuse Large B-Cell Lymphoma (DLBCL). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07189065","url":"https://clinicaltrials.gov/study/NCT07189065"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["rocbrutinib","bendamustine","rituximab","lenalidomide"],"companies":["lupeng-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07189065","phase":"2","setting":"An Open-Label, Randomized Controlled, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Rocbrutinib Monotherapy Versus Investigator's Choice of Therapy in Patients With Relapsed or Refractory Non-GCB Diffuse Large B-Cell Lymphoma","sponsor":"Guangzhou Lupeng Pharmaceutical Company LTD.","started":"2025-11-27","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07377578","kind":"trial","name":"A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma","aka":[],"tldr":"A phase 3 trial testing Rocbrutinib in mantle cell lymphoma, now recruiting.","summary":"A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma is a phase 3 interventional study registered as NCT07377578, led by Guangzhou Lupeng Pharmaceutical, and recruiting on the registry. Official title: A Randomised, Open-label, Multicenter, Phase III Clinical Study Comparing Rocbrutinib Monotherapy Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (PRIME Study). Planned enrolment is 394 participants (estimated). The study started in 2026-02-05 and primary completion is expected in 2031-05-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07377578","url":"https://clinicaltrials.gov/study/NCT07377578"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["rocbrutinib"],"companies":["lupeng-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07377578","phase":"3","setting":"A Randomized, Open-label, Multicenter, Phase III Clinical Study Comparing Rocbrutinib Monotherapy Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (PRIME Study)","sponsor":"Guangzhou Lupeng Pharmaceutical","started":"2026-02-05","startedType":"actual","enrolled":394,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06879717","kind":"trial","name":"A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients","aka":["PULMO-1"],"tldr":"A phase 1/2 trial of Dostarlimab, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by iOnctura, active and no longer recruiting.","summary":"A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients is a phase 1/2 interventional study registered as NCT06879717 by iOnctura, with 45 participants planned, started 2025-04-22 and due to reach its primary completion in 2027-01. Interventions recorded: roginolisib, Dostarlimab, Docetaxel. Conditions listed: Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Advanced Non Squamous NSCLC. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06879717","url":"https://clinicaltrials.gov/study/NCT06879717"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["dostarlimab","docetaxel"],"companies":["ionctura"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06879717","phase":"1/2","setting":"A Phase I/IIa Study of Roginolisib in Combination With Dostarlimab With or Without Docetaxel in Patients With Advanced Non-squamous NSCLC Who Have Progressed on Standard of Care Immune Checkpoint Therapy and Platinum Doublet Chemotherapy or Standard Immunotherapy Without Chemotherapy (PULMO-1)","sponsor":"iOnctura","started":"2025-04-22","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03033511","kind":"trial","name":"A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)","aka":["MERU"],"tldr":"A phase 3 trial of Rovalpituzumab tesirine and Dexamethasone in Small-cell lung cancer, run by AbbVie, recorded as terminated on the registry.","summary":"A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU) is a phase 3 interventional study registered as NCT03033511 by AbbVie, with 748 participants recorded, started 2017-02-07 and due to reach its primary completion in 2019-11-20. Interventions recorded: Placebo for dexamethasone, Placebo for rovalpituzumab tesirine, Rovalpituzumab tesirine, Dexamethasone. Conditions recorded: Small Cell Lung Cancer.\n\nLinked to the drug Rovalpituzumab tesirine because the registry names it among its interventions and Small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03033511","url":"https://clinicaltrials.gov/study/NCT03033511"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["rovalpituzumab-tesirine","dexamethasone"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03033511","phase":"3","setting":"A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)","sponsor":"AbbVie","started":"2017-02-07","startedType":"actual","yearReported":2020,"enrolled":748,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)","primary":true,"unit":"months","arms":[{"name":"Placebo","n":240,"value":9.79,"note":"95% CI 8.38 to 10.87; Figures from the ClinicalTrials.gov results section (first posted 2020-12-21), not from a publication"},{"name":"Rovalpituzumab Tesirine/Dexamethasone","n":217,"value":8.48,"note":"95% CI 7.26 to 10.18"}],"hr":1.07,"ci":[0.84,1.36],"p":"0.537","source":"https://clinicaltrials.gov/study/NCT03033511?tab=results"}]},{"id":"nct06149559","kind":"trial","name":"A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis","aka":[],"tldr":"A phase 2/3 trial of rozanolixizumab in childhood cancers, run by UCB Biopharma SRL, active and no longer recruiting.","summary":"A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis is a phase 2/3 interventional study registered as NCT06149559 by UCB Biopharma SRL, with 14 participants enrolled, started 2024-06-14 and due to reach its primary completion in 2026-10-05. Interventions recorded: rozanolixizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06149559","url":"https://clinicaltrials.gov/study/NCT06149559"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["childhood-cancers"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ucb"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06149559","phase":"2/3","setting":"An Open-label, Single-arm Study Evaluating the Activity, Safety, and Pharmacokinetics of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis","sponsor":"UCB Biopharma SRL","started":"2024-06-14","startedType":"actual","enrolled":14,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07648030","kind":"trial","name":"A Study of Rusfertide in Japanese Adults With Polycythemia Vera","aka":[],"tldr":"A phase 2 trial of Rusfertide in myeloproliferative neoplasms, run by Takeda, now recruiting.","summary":"A Study of Rusfertide in Japanese Adults With Polycythemia Vera is a phase 2 interventional study registered as NCT07648030 by Takeda, with 9 participants planned, started 2026-07-14 and due to reach its primary completion in 2027-10-28. Interventions recorded: Rusfertide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07648030","url":"https://clinicaltrials.gov/study/NCT07648030"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms"],"sections":[],"technologies":["peptide-drug-conjugate"],"targets":[],"drugs":["rusfertide"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07648030","phase":"2","setting":"A Phase 2 Open-label Trial to Evaluate the Efficacy and Safety of Rusfertide in Japanese Patients With Polycythemia Vera","sponsor":"Takeda","started":"2026-07-14","startedType":"actual","enrolled":9,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06926920","kind":"trial","name":"A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of Sacituzumab govitecan in triple-negative breast cancer, run by Gilead Sciences, now recruiting.","summary":"A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer is a phase 1/2 interventional study registered as NCT06926920 by Gilead Sciences, with 100 participants planned, started 2025-04-30 and due to reach its primary completion in 2028-06. Interventions recorded: Sacituzumab Govitecan-hziy (SG).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06926920","url":"https://clinicaltrials.gov/study/NCT06926920"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06926920","phase":"1/2","setting":"A Phase 1/2, Open-label Study of Sacituzumab Govitecan Administered at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer","sponsor":"Gilead Sciences","started":"2025-04-30","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07040644","kind":"trial","name":"A Study of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel in PD-L1 Positive Advanced TNBC","aka":[],"tldr":"A phase 2 trial of sacituzumab govitecan, toripalimab and nab-paclitaxel in triple-negative breast cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, not yet recruiting.","summary":"A Study of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel in PD-L1 Positive Advanced TNBC is a phase 2, randomised interventional study registered as NCT07040644 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, with a registry enrolment figure of 150 participants, started 2025-09 and due to reach its primary completion in 2027-06. Interventions recorded: Sacituzumab Govitecan (SG); Toripalimab; Nab-paclitaxel. Conditions listed: Triple Negative Breast Neoplasms. Triple-negative eligibility wording from the registry: \"* Histologically or cytologically confirmed triple-negative breast cancer (TNBC)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07040644","url":"https://clinicaltrials.gov/study/NCT07040644"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["adc","checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["sacituzumab-govitecan","toripalimab","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07040644","phase":"2","setting":"A Multi-center, Open-label, Randomized, Phase II Trial of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel as First-line Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","started":"2025-09","startedType":"estimated","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06312176","kind":"trial","name":"A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)","aka":[],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Pembrolizumab, Capecitabine and Doxorubicin in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010) is a phase 3 interventional study registered as NCT06312176 by Merck Sharp & Dohme LLC, with 1200 participants planned, started 2024-04-14 and due to reach its primary completion in 2027-07-11. Interventions recorded: Sacituzumab tirumotecan, Pembrolizumab, Paclitaxel, Nab-paclitaxel, Capecitabine and Liposomal doxorubicin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06312176","url":"https://clinicaltrials.gov/study/NCT06312176"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","pembrolizumab","capecitabine","doxorubicin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06312176","phase":"3","setting":"An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer","sponsor":"Merck Sharp & Dohme LLC","started":"2024-04-14","startedType":"actual","enrolled":1200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06841354","kind":"trial","name":"A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)","aka":["TroFuse-011"],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Pembrolizumab, Gemcitabine and Carboplatin in triple-negative breast cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) is a phase 3 interventional study registered as NCT06841354 by Merck Sharp & Dohme LLC, with 1000 participants planned, started 2025-03-16 and due to reach its primary completion in 2030-05-18. Interventions recorded: Sacituzumab tirumotecan, Pembrolizumab, Rescue Medication, Paclitaxel, Nab-paclitaxel and Gemcitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06841354","url":"https://clinicaltrials.gov/study/NCT06841354"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","pembrolizumab","gemcitabine","carboplatin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06841354","phase":"3","setting":"A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-03-16","startedType":"actual","enrolled":1000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07060989","kind":"trial","name":"A Study of Safety, Tolerability and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation","aka":[],"tldr":"A phase 1/2 trial of NTS071 in advanced solid tumours, run by Nutshell Therapeutics (Shanghai) Co., LTD., now recruiting.","summary":"A Study of Safety, Tolerability and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation is a phase 1/2 interventional study registered as NCT07060989 by Nutshell Therapeutics (Shanghai) Co., LTD., with 220 participants planned, started 2025-08-04 and due to reach its primary completion in 2028-12. Interventions recorded: NTS071.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07060989","url":"https://clinicaltrials.gov/study/NCT07060989"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["tp53"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07060989","phase":"1/2","setting":"A Phase 1/2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation","sponsor":"Nutshell Therapeutics (Shanghai) Co., LTD.","started":"2025-08-04","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04165317","kind":"trial","name":"A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer","aka":["CREST"],"tldr":"A phase 3 trial testing Sasanlimab in bladder & urothelial cancer, active and no longer recruiting.","summary":"A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer is a phase 3 interventional study registered as NCT04165317, led by Pfizer, and active but no longer recruiting on the registry. Official title: A Phase 3, Multinational, Randomised, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC. Planned enrolment is 1068 participants (actual). The study started in 2019-12-30 and primary completion is expected in 2024-12-02. Results have been posted on ClinicalTrials.gov; they are not yet summarised here.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04165317","url":"https://clinicaltrials.gov/study/NCT04165317"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["sasanlimab"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04165317","phase":"3","setting":"A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC","sponsor":"Pfizer","started":"2019-12-30","startedType":"actual","enrolled":1068,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05570253","kind":"trial","name":"A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer","aka":[],"tldr":"A phase 2 trial of eribulin and evexomostat in triple-negative breast cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer is a phase 2, randomised interventional study registered as NCT05570253 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 55 participants, started 2022-10-03 and due to reach its primary completion in 2027-10. Interventions recorded: Eribulin; SDX-7320; Placebo. Conditions listed: Breast Cancer; Metastatic Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Male or female with histologically and/or cytologically confirmed diagnosis of triple-negative metastatic breast cancer defined as estrogen and progesterone receptor staining ≤10%; and HER2-negative defined as IHC 0 to 1+ at enrolling institution (note: if IHC is equivocal, non-amplified status by\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05570253","url":"https://clinicaltrials.gov/study/NCT05570253"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["eribulin","evexomostat"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05570253","phase":"2","setting":"\"A Phase 2, Double Blinded, Randomized Controlled Trial of Evexomostat (SDX-7320) or Placebo in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2022-10-03","startedType":"actual","enrolled":55,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04414475","kind":"trial","name":"A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refrac","aka":[],"tldr":"A phase 2 trial of Selinexor, Dexamethasone, Bortezomib in multiple myeloma, run by Karyopharm Therapeutics Inc, now recruiting.","summary":"A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM. is a phase 2 interventional study registered as NCT04414475 by Karyopharm Therapeutics Inc, with 127 participants planned, started 2020-07-01 and due to reach its primary completion in 2028-01. Interventions recorded: Selinexor, Dexamethasone, Bortezomib. Conditions listed: Multiple Myeloma, Refractory. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04414475","url":"https://clinicaltrials.gov/study/NCT04414475"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","kinase-inhibitors"],"targets":[],"drugs":["selinexor","dexamethasone","bortezomib"],"companies":["karyopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04414475","phase":"2","setting":"A Phase 2b, Open-label, Multi-arm Clinical Trial of Selinexor Plus Low-dose Dexamethasone (Sd) in Patients With Penta-refractory Multiple Myeloma or Selinexor and Bortezomib Plus Low-dose Dexamethasone (SVd) in Patients With Triple-class Refractory Multiple Myeloma","sponsor":"Karyopharm Therapeutics Inc","started":"2020-07-01","startedType":"actual","enrolled":127,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03157128","kind":"trial","name":"A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRET","aka":["LIBRETTO-001"],"tldr":"A phase 1/2 trial of Selpercatinib in non-small-cell lung cancer and small-cell lung cancer, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001) is a phase 1/2 interventional study registered as NCT03157128 by Eli Lilly and Company, with 857 participants enrolled, started 2017-05-02 and due to reach its primary completion in 2025-02-14. Interventions recorded: LOXO-292. Conditions listed: Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Any Solid Tumor. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03157128","url":"https://clinicaltrials.gov/study/NCT03157128"},{"label":"LIBRETTO-001 (New England Journal of Medicine 2020)","url":"https://doi.org/10.1056/NEJMoa2005653"},{"label":"NICE TA1042: selpercatinib for previously treated RET fusion-positive advanced non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1042"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","thyroid","ret-fusion-nsclc","medullary-thyroid-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["selpercatinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":["libretto-431","arrow-thyroid"],"people":[],"bottlenecks":[],"keyPapers":["paper-libretto-001-selpercatinib-nsclc-nejm-2020","paper-nct03157128-j-clin-oncol-2024-update"],"journals":[],"dependsOn":[],"notes":["In the first 105 consecutively enrolled patients with RET fusion-positive non-small-cell lung cancer who had had at least platinum-based chemotherapy, objective response was 64 percent (95 percent confidence interval 54 to 73) with median duration of response 17.5 months and 63 percent of responses ongoing at a median 12.1 months. Among 39 previously untreated patients, response was 85 percent (70 to 94) with 90 percent ongoing at six months, and among 11 patients with measurable central nervous system metastases, intracranial response was 91 percent (59 to 100). Grade 3 or higher events were hypertension (14 percent), raised alanine aminotransferase (12 percent) and aspartate aminotransferase (10 percent); 12 of 531 patients (2 percent) discontinued for a drug-related event (New England Journal of Medicine 2020)."],"nct":"NCT03157128","phase":"1/2","setting":"A Phase 1/2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001)","sponsor":"Eli Lilly and Company","result":"Objective response 64 percent after platinum chemotherapy and 85 percent in previously untreated RET fusion-positive non-small-cell lung cancer; intracranial response 91 percent.","started":"2017-05-02","startedType":"actual","yearReported":2026,"enrolled":857,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase 2: Objective Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment","primary":true,"unit":"%","arms":[{"name":"Phase 2, Cohort 1: RET Fusion Solid Tumor","n":307,"value":62.9,"note":"95% CI 57.2 to 68.3; Figures from the ClinicalTrials.gov results section (first posted 2026-04-16), not from a publication"},{"name":"Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy","n":74,"value":79.7,"note":"95% CI 68.8 to 88.2"},{"name":"Phase 2, Cohort 3: RET Mutant MTC","n":143,"value":77.6,"note":"95% CI 69.9 to 84.2"},{"name":"Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy","n":116,"value":82.8,"note":"95% CI 74.6 to 89.1"},{"name":"Phase 2, Cohort 5: Advanced RET Altered Solid Tumor","n":201,"value":57.2,"note":"95% CI 50.1 to 64.2"},{"name":"Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants","n":16,"value":31.3,"note":"95% CI 11.0 to 58.7"}],"source":"https://clinicaltrials.gov/study/NCT03157128?tab=results"}]},{"id":"nct04280081","kind":"trial","name":"A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer a","aka":["LIBRETTO-321"],"tldr":"A phase 2 trial of Selpercatinib in thyroid cancer, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation is a phase 2 interventional study registered as NCT04280081 by Eli Lilly and Company, with 77 participants enrolled, started 2020-03-16 and due to reach its primary completion in 2021-03-25. Interventions recorded: Selpercatinib. Conditions listed: Solid Tumor, Medullary Thyroid Cancer. Results were posted on ClinicalTrials.gov in 2022; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04280081","url":"https://clinicaltrials.gov/study/NCT04280081"}],"tags":["ctgov-ingest"],"related":[],"cancers":["thyroid","medullary-thyroid-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["selpercatinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04280081","phase":"2","setting":"A Phase 2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including Rearranged in Transfection (RET) Fusion-Positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation","sponsor":"Eli Lilly and Company","started":"2020-03-16","startedType":"actual","yearReported":2022,"enrolled":77,"enrolledBasis":"registry","outcomes":[{"endpoint":"Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC), Overall Response (CR/PR)","primary":true,"unit":"%","arms":[{"name":"RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1","n":26,"value":69.2,"note":"95% CI 48.2 to 85.7; Figures from the ClinicalTrials.gov results section (first posted 2022-06-02), not from a publication"},{"name":"RET Fusion Positive Thyroid Cancer (TC) Cohort 1","n":1,"value":100,"note":"95% CI 2.5 to 100.0"},{"name":"RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2","n":26,"value":57.7,"note":"95% CI 36.9 to 76.6"}],"source":"https://clinicaltrials.gov/study/NCT04280081?tab=results"},{"endpoint":"Enrolled Population: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by IRC, Overall Response (CR/PR)","primary":true,"unit":"%","arms":[{"name":"Non-small Cell Lung Cancer (All NSCLC)","n":47,"value":66,"note":"95% CI 50.7 to 79.1; Figures from the ClinicalTrials.gov results section (first posted 2022-06-02), not from a publication"},{"name":"Thyroid Cancer (All TC)","n":1,"value":100,"note":"95% CI 2.5 to 100.0"},{"name":"Medullary Thyroid Cancer (All MTC)","n":29,"value":58.6,"note":"95% CI 38.9 to 76.5"}],"source":"https://clinicaltrials.gov/study/NCT04280081?tab=results"}]},{"id":"nct04819100","kind":"trial","name":"A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)","aka":["LIBRETTO-432"],"tldr":"A phase 3 trial of Selpercatinib in non-small-cell lung cancer, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) is a phase 3 interventional study registered as NCT04819100 by Eli Lilly and Company, with 152 participants enrolled, started 2021-12-20 and due to reach its primary completion in 2026-01-12. Interventions recorded: Selpercatinib and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04819100","url":"https://clinicaltrials.gov/study/NCT04819100"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","resectable-nsclc","ret-fusion-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["selpercatinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04819100-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04819100","phase":"3","setting":"LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC","sponsor":"Eli Lilly and Company","started":"2021-12-20","startedType":"actual","enrolled":152,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06012435","kind":"trial","name":"A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of Docetaxel in non-small-cell lung cancer, run by Seagen, a wholly owned subsidiary of Pfizer, active and no longer recruiting.","summary":"A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT06012435 by Seagen, a wholly owned subsidiary of Pfizer, with 762 participants enrolled, started 2024-02-21 and due to reach its primary completion in 2026-05-18. Interventions recorded: sigvotatug vedotin and docetaxel.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06012435","url":"https://clinicaltrials.gov/study/NCT06012435"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06012435","phase":"3","setting":"A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE SIGVOTATUG VEDOTIN COMPARED WITH DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY TREATED NON-SMALL CELL LUNG CANCER (BE6A LUNG-01)","sponsor":"Seagen, a wholly owned subsidiary of Pfizer","started":"2024-02-21","startedType":"actual","enrolled":762,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07726992","kind":"trial","name":"A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC","aka":["NiBladder 2"],"tldr":"A phase 3 trial testing SHR-1501 in bladder & urothelial cancer, now recruiting.","summary":"A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC is a phase 3 interventional study registered as NCT07726992, led by Suzhou Suncadia Biopharmaceuticals, and recruiting on the registry. Official title: A Multicenter, Randomised, Double-blind Phase III Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Placebo Combined With BCG In Patients With High-risk BCG-naive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC). Planned enrolment is 750 participants (estimated). The study started in 2026-08-25 and primary completion is expected in 2029-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07726992","url":"https://clinicaltrials.gov/study/NCT07726992"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-1501"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07726992","phase":"3","setting":"A Multicenter, Randomized, Double-blind Phase III Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Placebo Combined With BCG In Patients With High-risk BCG-naive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC)","sponsor":"Suzhou Suncadia Biopharmaceuticals","started":"2026-08-25","startedType":"actual","enrolled":750,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06754930","kind":"trial","name":"A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC","aka":[],"tldr":"A phase 1/2 trial of Adebrelimab, SHR-8068, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC is a phase 1/2 interventional study registered as NCT06754930 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 400 participants planned, started 2025-02-18 and due to reach its primary completion in 2027-12. Interventions recorded: SHR-1826, SHR-1316, SHR-9839, SHR-8068, Ametinib mesylate. Conditions listed: Non-small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06754930","url":"https://clinicaltrials.gov/study/NCT06754930"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["adebrelimab","shr-8068","carboplatin"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06754930","phase":"1/2","setting":"A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-02-18","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06703177","kind":"trial","name":"A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SHR-8068, Bevacizumab, Leucovorin (folinic acid), Adebrelimab and Capecitabine in advanced solid tumours, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors is a phase 1/2 interventional study registered as NCT06703177 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 876 participants planned, started 2025-02-18 and due to reach its primary completion in 2026-01-01. Interventions recorded: SHR-1826, SHR-4642, SHR-9839, SHR-8068, Bevacizumab Injection and Fluorouracil Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06703177","url":"https://clinicaltrials.gov/study/NCT06703177"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-8068","bevacizumab","leucovorin","adebrelimab","capecitabine"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06703177","phase":"1/2","setting":"Phase IB/II Study of Safety, Tolerability and Efficacy of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-02-18","startedType":"actual","enrolled":876,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06764628","kind":"trial","name":"A Study of SHR-4375 in Subjects With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SHR-4375 in advanced solid tumours, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Study of SHR-4375 in Subjects With Solid Tumors is a phase 1/2 interventional study registered as NCT06764628 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 208 participants planned, started 2025-01-09 and due to reach its primary completion in 2027-05. Interventions recorded: SHR-4375.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06764628","url":"https://clinicaltrials.gov/study/NCT06764628"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06764628","phase":"1/2","setting":"An Open-label, Single-arm, Multicenter Phase I/II Clinical Study of SHR-4375 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-01-09","startedType":"actual","enrolled":208,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07298772","kind":"trial","name":"A Study of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SHR-4375 Injection in advanced solid tumours, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Study of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Solid Tumors is a phase 1/2 interventional study registered as NCT07298772 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 198 participants planned, started 2026-01-07 and due to reach its primary completion in 2027-01. Interventions recorded: SHR-4375 Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07298772","url":"https://clinicaltrials.gov/study/NCT07298772"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07298772","phase":"1/2","setting":"A Phase Ib/II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2026-01-07","startedType":"actual","enrolled":198,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07231211","kind":"trial","name":"A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Trastuzumab rezetecan in advanced solid tumours, run by Shanghai Shengdi Pharmaceutical Co., Ltd, now recruiting.","summary":"A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07231211 by Shanghai Shengdi Pharmaceutical Co., Ltd, with 258 participants planned, started 2025-11-20 and due to reach its primary completion in 2026-10. Interventions recorded: SHR-4610 Injection and SHR-A1811 for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07231211","url":"https://clinicaltrials.gov/study/NCT07231211"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07231211","phase":"1/2","setting":"An Open-label, Multicenter Phase I/II Clinical Study of SHR-4610 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy","sponsor":"Shanghai Shengdi Pharmaceutical Co., Ltd","started":"2025-11-20","startedType":"actual","enrolled":258,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07229586","kind":"trial","name":"A Study of SHR-7367 With Anti-tumor Agents in Patients With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Adebrelimab and Gemcitabine in advanced solid tumours, run by Shanghai Hengrui Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of SHR-7367 With Anti-tumor Agents in Patients With Solid Tumors is a phase 1/2 interventional study registered as NCT07229586 by Shanghai Hengrui Pharmaceutical Co., Ltd., with 100 participants planned, started 2025-12-02 and due to reach its primary completion in 2027-12. Interventions recorded: SHR-7367 Injection, SHR-1316 Injection, Paclitaxel for Injection and Gemcitabine Hydrochloride for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07229586","url":"https://clinicaltrials.gov/study/NCT07229586"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["adebrelimab","gemcitabine"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07229586","phase":"1/2","setting":"A Phase IB/II Clinical Study of the Safety, Tolerability and Efficacy of SHR-7367 in Combination With Anti-tumor Agents in Subjects With Solid Tumors","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2025-12-02","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06430437","kind":"trial","name":"A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations","aka":[],"tldr":"A phase 3 trial of Trastuzumab rezetecan, Cisplatin in non-small-cell lung cancer and small-cell lung cancer, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations is a phase 3 interventional study registered as NCT06430437 by Jiangsu HengRui Medicine Co., Ltd., with 300 participants planned, started 2024-07-29 and due to reach its primary completion in 2026-02. Interventions recorded: SHR-A1811, PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin. Conditions listed: Non-Small Cell Lung Cancer With HER2- Mutations. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06430437","url":"https://clinicaltrials.gov/study/NCT06430437"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","her2-mutant-nsclc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","cisplatin"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06430437","phase":"3","setting":"A Randomized, Open-Label, Multicenter Phase III Study of SHR-A1811 for First-Line Treatment in Subjects With HER2-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2024-07-29","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06828354","kind":"trial","name":"A Study of SHR-A1811 in Subjects With Ovarian Cancer","aka":[],"tldr":"A phase 3 trial of Trastuzumab rezetecan, Paclitaxel / nab-paclitaxel, Gemcitabine in ovarian cancer, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Study of SHR-A1811 in Subjects With Ovarian Cancer is a phase 3 interventional study registered as NCT06828354 by Jiangsu HengRui Medicine Co., Ltd., with 300 participants planned, started 2025-03-13 and due to reach its primary completion in 2027-05. Interventions recorded: SHR-A1811, Paclitaxel Injection, Doxorubicin Hydrochloride Liposome Injection, Gemcitabine Hydrochloride for Injection, Topotecan Hydrochloride for Injection. Conditions listed: Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06828354","url":"https://clinicaltrials.gov/study/NCT06828354"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","paclitaxel","gemcitabine","topotecan"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06828354","phase":"3","setting":"An Open-label, Randomized, Multicenter Phase III Clinical Trial of SHR-A1811 Versus Investigator-selected Chemotherapy for Platinum-resistant Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-03-13","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07450976","kind":"trial","name":"A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of SHR-A1904 for Injection in biliary tract cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer is a phase 2 interventional study registered as NCT07450976 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 151 participants planned, started 2026-03-25 and due to reach its primary completion in 2030-12. Interventions recorded: SHR-A1904 for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07450976","url":"https://clinicaltrials.gov/study/NCT07450976"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07450976","phase":"2","setting":"A Phase IIa/IIb Clinical Study of SHR-A1904 in Patients With Previous Systemic Treatment Failure, Positive CLDN18.2 Expression of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2026-03-25","startedType":"actual","enrolled":151,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07183189","kind":"trial","name":"A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC","aka":[],"tldr":"A phase 3 trial of SHR-A2009, Aumolertinib in non-small-cell lung cancer and small-cell lung cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC is a phase 3 interventional study registered as NCT07183189 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 576 participants planned, started 2025-10-30 and due to reach its primary completion in 2032-11. Interventions recorded: SHR-A2009 ; Aumolertinib, Aumolertinib. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07183189","url":"https://clinicaltrials.gov/study/NCT07183189"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["shr-a2009","aumolertinib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07183189","phase":"3","setting":"A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib as First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutations","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-10-30","startedType":"actual","enrolled":576,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06671379","kind":"trial","name":"A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC","aka":[],"tldr":"A phase 3 trial testing SHR-A2009 in non-small-cell lung cancer, active and no longer recruiting.","summary":"A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC is a phase 3 interventional study registered as NCT06671379, led by Suzhou Suncadia Biopharmaceuticals, and active but no longer recruiting on the registry. Official title: A Randomised, Open-label, Multicenter, Phase III Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy. Planned enrolment is 498 participants (actual). The study started in 2024-11-29 and primary completion is expected in 2026-12. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06671379","url":"https://clinicaltrials.gov/study/NCT06671379"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-a2009"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06671379","phase":"3","setting":"A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy","sponsor":"Suzhou Suncadia Biopharmaceuticals","started":"2024-11-29","startedType":"actual","enrolled":498,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06589778","kind":"trial","name":"A Study of SHR-A2102 in Combination With Adebrelimab and SHR-8068 in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of SHR-A2102, Adebrelimab, SHR-8068 in non-small-cell lung cancer and small-cell lung cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of SHR-A2102 in Combination With Adebrelimab and SHR-8068 in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT06589778 by Shanghai Hengrui Pharmaceutical Co., Ltd., with 124 participants planned, started 2024-09-27 and due to reach its primary completion in 2026-04-30. Interventions recorded: SHR-A2102, Adebelimab (SHR-1316), SHR-8068. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06589778","url":"https://clinicaltrials.gov/study/NCT06589778"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["shr-a2102","adebrelimab","shr-8068"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06589778","phase":"1/2","setting":"Safety, Tolerability, and Efficacy of SHR-A2102 in Combination With Adebrelimab, With SHR-8068, in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase IB/II Open-Label, Multicenter Clinical Study","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2024-09-27","startedType":"actual","enrolled":124,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07229729","kind":"trial","name":"A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of SHR-A2102, Adebrelimab, Paclitaxel / nab-paclitaxel in non-small-cell lung cancer and small-cell lung cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT07229729 by Shanghai Hengrui Pharmaceutical Co., Ltd., with 300 participants planned, started 2025-11-24 and due to reach its primary completion in 2026-10. Interventions recorded: SHR-A2102, Adebrelimab, Paclitaxel, Carboplatin, Alomnertinib Mesilate. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07229729","url":"https://clinicaltrials.gov/study/NCT07229729"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-a2102","adebrelimab","paclitaxel","carboplatin","osimertinib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07229729","phase":"2","setting":"A Randomized, Open-label, Multicenter Phase II Clinical Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Perioperative Treatment of Resectable Non-small Cell Lung Cancer","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2025-11-24","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07418749","kind":"trial","name":"A Study of SHR-A2102 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-based Chemotherapy and PD-(L)1 Inhibitor Treatment Failed Recurrent or Metastatic Cervical Cancer","aka":[],"tldr":"A phase 3 trial testing SHR-A2102 in cervical cancer, now recruiting.","summary":"A Study of SHR-A2102 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-based Chemotherapy and PD-(L)1 Inhibitor Treatment Failed Recurrent or Metastatic Cervical Cancer is a phase 3 interventional study registered as NCT07418749, led by Suzhou Suncadia Biopharmaceuticals, and recruiting on the registry. Official title: An Open-label, Randomised, Controlled, Multicenter, Phase III Study of SHR-A2102 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-based Chemotherapy and PD-(L)1 Inhibitor Treatment Failed Recurrent or Metastatic Cervical Cancer. Planned enrolment is 398 participants (estimated). The study started in 2026-03-30 and primary completion is expected in 2027-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07418749","url":"https://clinicaltrials.gov/study/NCT07418749"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-a2102"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07418749","phase":"3","setting":"An Open-label, Randomized, Controlled, Multicenter, Phase III Study of SHR-A2102 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-based Chemotherapy and PD-(L)1 Inhibitor Treatment Failed Recurrent or Metastatic Cervical Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals","started":"2026-03-30","startedType":"actual","enrolled":398,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07230106","kind":"trial","name":"A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer","aka":[],"tldr":"A phase 2 trial of HS-20093, Rezvilutamide, Abiraterone acetate in prostate cancer, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer is a phase 2 interventional study registered as NCT07230106 by Jiangsu HengRui Medicine Co., Ltd., with 218 participants planned, started 2025-12-08 and due to reach its primary completion in 2028-12. Interventions recorded: HS-20093 for Injection, SHR3680 Tablet, Abiraterone Tablet, SHR2554 Tablet, Enzalutamide Tablet. Conditions listed: Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07230106","url":"https://clinicaltrials.gov/study/NCT07230106"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["hs-20093","rezvilutamide","abiraterone","enzalutamide"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07230106","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of HS-20093 or SHR2554 Tablets in Combination With Novel Hormonal Agents in Participants With Metastatic Prostate Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-12-08","startedType":"actual","enrolled":218,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06668961","kind":"trial","name":"A Study of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Sq","aka":[],"tldr":"A phase 2 trial of SI-B001 in head and neck squamous cell carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma is a phase 2 interventional study registered as NCT06668961 by Sichuan Baili Pharmaceutical Co., Ltd., with 48 participants enrolled, started 2024-11-07 and due to reach its primary completion in 2026-11. Interventions recorded: SI-B001, SI-B003. Conditions listed: Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06668961","url":"https://clinicaltrials.gov/study/NCT06668961"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["si-b001"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06668961","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Safety and Efficacy of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy (SI-B001+SI-B003+ Platinum-based Chemotherapy) as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-11-07","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05668858","kind":"trial","name":"A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma","aka":[],"tldr":"A phase 1/2 trial of SI-B001 in head and neck squamous cell carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma is a phase 1/2 interventional study registered as NCT05668858 by Sichuan Baili Pharmaceutical Co., Ltd., with 70 participants enrolled, started 2023-02-10 and due to reach its primary completion in 2026-12. Interventions recorded: SI-B001 and SI-B003.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05668858","url":"https://clinicaltrials.gov/study/NCT05668858"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":["si-b001"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05668858","phase":"1/2","setting":"A Phase Ib/II Clinical Study of SI-B001+SI-B003 Dual-drug No-combination or Combined Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-02-10","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05949606","kind":"trial","name":"A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of SI-B001 in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT05949606 by Sichuan Baili Pharmaceutical Co., Ltd., with 95 participants enrolled, started 2023-10-30 and due to reach its primary completion in 2026-12. Interventions recorded: SI-B001, SI-B003. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05949606","url":"https://clinicaltrials.gov/study/NCT05949606"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["si-b001"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05949606","phase":"1/2","setting":"A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of SI-B001+SI-B003 With or Without Chemotherapy (SI-B001+SI-B003± Chemotherapy) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-10-30","startedType":"actual","enrolled":95,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05956587","kind":"trial","name":"A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other","aka":[],"tldr":"A phase 2 trial of Izalontamab brengitecan in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors is a phase 2 interventional study registered as NCT05956587 by Sichuan Baili Pharmaceutical Co., Ltd., with 121 participants planned, started 2024-01-29 and due to reach its primary completion in 2026-12. Interventions recorded: BL-B01D1, SI-B003. Conditions listed: Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05956587","url":"https://clinicaltrials.gov/study/NCT05956587"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","nasopharyngeal","recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":["adc","bispecific-adc"],"targets":[],"drugs":["izalontamab-brengitecan"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05956587","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2024-01-29","startedType":"actual","enrolled":121,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05965856","kind":"trial","name":"A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors","aka":[],"tldr":"A phase 2 trial of BL-B01D1 in bladder & urothelial cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors is a phase 2 interventional study registered as NCT05965856 by Sichuan Baili Pharmaceutical Co., Ltd., with 52 participants planned, started 2023-12-11 and due to reach its primary completion in 2026-12. Interventions recorded: BL-B01D1 and SI-B003.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05965856","url":"https://clinicaltrials.gov/study/NCT05965856"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05965856","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-12-11","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06042894","kind":"trial","name":"A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of BL-B01D1 in advanced solid tumours, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer is a phase 2 interventional study registered as NCT06042894 by Sichuan Baili Pharmaceutical Co., Ltd., with 58 participants planned, started 2023-12-12 and due to reach its primary completion in 2026-12. Interventions recorded: BL-B01D1 and SI-B003.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06042894","url":"https://clinicaltrials.gov/study/NCT06042894"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06042894","phase":"2","setting":"A Phase II Clinical Trial to Evaluate the Efficacy and Safety of SI-B003 Monotherapy or BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-12-12","startedType":"actual","enrolled":58,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06008054","kind":"trial","name":"A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric ","aka":[],"tldr":"A phase 2 trial of Izalontamab brengitecan in colorectal cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors is a phase 2 interventional study registered as NCT06008054 by Sichuan Baili Pharmaceutical Co., Ltd., with 376 participants planned, started 2023-11-16 and due to reach its primary completion in 2026-12. Interventions recorded: SI-B003, BL-B01D1, PD-1 Monoclonal Antibody. Conditions listed: Esophageal Cancer, Gastric Cancer, Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06008054","url":"https://clinicaltrials.gov/study/NCT06008054"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["adc","bispecific-adc"],"targets":[],"drugs":["izalontamab-brengitecan"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06008054","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B003 Monotherapy, BL-B01D1+SI-B003 Combination Therapy and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2023-11-16","startedType":"actual","enrolled":376,"enrolledBasis":"registry","outcomes":[]},{"id":"simrise","kind":"trial","name":"A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)","aka":["SIMRISE"],"tldr":"A phase 3 trial testing SIM0270 in HR-positive / HER2-negative breast cancer, active and no longer recruiting.","summary":"A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE) is a phase 3 interventional study registered as NCT06680921, led by Jiangsu Simcere Pharmaceutical with Nanjing Zaiming Pharmaceutical, and active but no longer recruiting on the registry. Official title: A Randomised, Open-label, Phase III Study of SIM0270 Combined With Everolimus Versus Treatment of Physician's Choice in Patients With CDK4/6 Inhibitors Previously Treated, ER+/HER2- Locally Advanced or Metastatic Breast Cancer. Planned enrolment is 482 participants (actual). The study started in 2024-11-14 and primary completion is expected in 2028-08-31. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06680921","url":"https://clinicaltrials.gov/study/NCT06680921"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":[],"targets":[],"drugs":["sim0270"],"companies":["simcere"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06680921","phase":"3","setting":"A Randomized, Open-label, Phase III Study of SIM0270 Combined With Everolimus Versus Treatment of Physician's Choice in Patients With CDK4/6 Inhibitors Previously Treated, ER+/HER2- Locally Advanced or Metastatic Breast Cancer","sponsor":"Jiangsu Simcere Pharmaceutical","started":"2024-11-14","startedType":"actual","enrolled":482,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06130280","kind":"trial","name":"A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic Resonance Imaging (MRI) in People With Liver Metastasis From Colorectal","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic Resonance Imaging (MRI) in People With Liver Metastasis From Colorectal Cancer is a phase 2, interventional study registered as NCT06130280 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 32 participants, started 2023-11-08 and due to reach its primary completion in 2026-11. Interventions recorded: MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT). Conditions listed: Colorectal Cancer; Liver Metastases. Primary outcome: Local control rate CRC liver metastasis. Colorectal eligibility wording from the registry: \"* Histologically confirmed colorectal carcinoma and evidence of liver metastasis on imaging\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06130280","url":"https://clinicaltrials.gov/study/NCT06130280"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":["elekta"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06130280","phase":"2","setting":"Ablative Dose Single Fraction MRguided Colorectal Liver Metastasis SBRT","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2023-11-08","startedType":"actual","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07241936","kind":"trial","name":"A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SYS6010 in advanced solid tumours, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., now recruiting.","summary":"A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07241936 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., with 444 participants planned, started 2025-11-13 and due to reach its primary completion in 2027-10-30. Interventions recorded: sirolimus (albumin-bound), DP303c, SYS6043, SYS6002 and SYS6010.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07241936","url":"https://clinicaltrials.gov/study/NCT07241936"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["sys6010"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07241936","phase":"1/2","setting":"A Phase Ib/II Clinical Trial on the Safety and Efficacy of Sirolimus (Albumin-bound) Combined With Different ADCs in Patients With Advanced Solid Tumors","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","started":"2025-11-13","startedType":"actual","enrolled":444,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05816252","kind":"trial","name":"A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-","aka":[],"tldr":"A phase 2 trial of Sacituzumab tirumotecan, Pembrolizumab, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Klus Pharma Inc., active and no longer recruiting.","summary":"A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003) is a phase 2 interventional study registered as NCT05816252 by Klus Pharma Inc., with 356 participants enrolled, started 2023-04-19 and due to reach its primary completion in 2026-06-30. Interventions recorded: SKB264, Pembrolizumab, Carboplatin, Osimertinib. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05816252","url":"https://clinicaltrials.gov/study/NCT05816252"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["sacituzumab-tirumotecan","pembrolizumab","carboplatin","osimertinib"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05816252","phase":"2","setting":"A Phase II Study of SKB264 as Monotherapy or as Combination Therapy in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"Klus Pharma Inc.","started":"2023-04-19","startedType":"actual","enrolled":356,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06670196","kind":"trial","name":"A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advan","aka":[],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Osimertinib in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06670196 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 420 participants planned, started 2024-11-27 and due to reach its primary completion in 2027-05. Interventions recorded: SKB264, Osimertinib. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06670196","url":"https://clinicaltrials.gov/study/NCT06670196"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","osimertinib"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06670196","phase":"3","setting":"A Randomized, Open-Label, Multicenter, Phase III Clinical Study of SKB264 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2024-11-27","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06711900","kind":"trial","name":"A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative P","aka":[],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Pembrolizumab, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06711900 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 432 participants planned, started 2024-10-30 and due to reach its primary completion in 2026-12. Interventions recorded: SKB264, Pembrolizumab, pemetrexed, carboplatin or cisplatin. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06711900","url":"https://clinicaltrials.gov/study/NCT06711900"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sacituzumab-tirumotecan","pembrolizumab","pemetrexed"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06711900","phase":"3","setting":"A Randomized, Open-Label, Multicenter Phase 3 Clinical Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2024-10-30","startedType":"actual","enrolled":432,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06448312","kind":"trial","name":"A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06448312 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 406 participants planned, started 2024-06-07 and due to reach its primary completion in 2026-11. Interventions recorded: SKB264, Pembrolizumab. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06448312","url":"https://clinicaltrials.gov/study/NCT06448312"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sacituzumab-tirumotecan","pembrolizumab"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct06448312-lancet-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06448312","phase":"3","setting":"A Randomized, Open-Label, Multicenter Phase III Clinical Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for PD-L1 Positive Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2024-06-07","startedType":"actual","enrolled":406,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06279364","kind":"trial","name":"A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 3 trial of Capecitabine, Eribulin and Carboplatin in triple-negative breast cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer is a phase 3 interventional study registered as NCT06279364 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 524 participants planned, started 2024-02-28 and due to reach its primary completion in 2026-07. Interventions recorded: SKB264, Paclitaxel, Nab-paclitaxel, Capecitabine, Eribulin and Carboplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06279364","url":"https://clinicaltrials.gov/study/NCT06279364"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["capecitabine","eribulin","carboplatin"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06279364","phase":"3","setting":"A Randomized, Open-Label, Multicenter Phase 3 Study of SKB264 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2024-02-28","startedType":"actual","enrolled":524,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07071337","kind":"trial","name":"A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy","aka":[],"tldr":"A phase 3 trial of Capecitabine in advanced solid tumours, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy is a phase 3 interventional study registered as NCT07071337 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 430 participants planned, started 2025-07-18 and due to reach its primary completion in 2027-07. Interventions recorded: SKB264, Nab-paclitaxel, Paclitaxel and Capecitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07071337","url":"https://clinicaltrials.gov/study/NCT07071337"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07071337","phase":"3","setting":"A Randomized, Open-label, Multicenter Phase III Clinical Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2-negative (HER2-) Breast Cancer Who Have Previously Failed Endocrine Therapy","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2025-07-18","startedType":"actual","enrolled":430,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07448922","kind":"trial","name":"A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors","aka":[],"tldr":"A phase 2 trial of Carboplatin and Bevacizumab in advanced solid tumours, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors is a phase 2 interventional study registered as NCT07448922 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 280 participants planned, started 2026-04-08 and due to reach its primary completion in 2027-12-31. Interventions recorded: SKB518 for injection, Carboplatin (AUC 5) and Bevacizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07448922","url":"https://clinicaltrials.gov/study/NCT07448922"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["carboplatin","bevacizumab"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07448922","phase":"2","setting":"An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignancies","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-04-08","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07019675","kind":"trial","name":"A Study of SKB518 in Patients With Lung Cancer","aka":[],"tldr":"A phase 2 trial of Tislelizumab and Carboplatin in advanced solid tumours, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"A Study of SKB518 in Patients With Lung Cancer is a phase 2 interventional study registered as NCT07019675 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 192 participants planned, started 2025-08-29 and due to reach its primary completion in 2027-02-20. Interventions recorded: SKB518, Tislelizumab and Carboplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07019675","url":"https://clinicaltrials.gov/study/NCT07019675"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tislelizumab","carboplatin"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07019675","phase":"2","setting":"A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SKB518 in Patients With Lung Cancer","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2025-08-29","startedType":"actual","enrolled":192,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07622186","kind":"trial","name":"A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)","aka":[],"tldr":"A phase 2 trial of Osimertinib, Furmonertinib, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC) is a phase 2 interventional study registered as NCT07622186 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 150 participants planned, started 2026-07-15 and due to reach its primary completion in 2028-12-31. Interventions recorded: SKB571 for injection, Osimertinib, Furmonertinib, carboplatin, Cisplatin. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07622186","url":"https://clinicaltrials.gov/study/NCT07622186"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["osimertinib","furmonertinib","carboplatin","cisplatin","pembrolizumab"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07622186","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-07-15","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06359860","kind":"trial","name":"A Study of ST-1898 for Unresectable or Metastatic Melanoma","aka":[],"tldr":"A phase 1/2 trial of ST-1898 tablets in melanoma, run by Beijing Scitech-Mq Pharmaceuticals Limited, now recruiting.","summary":"A Study of ST-1898 for Unresectable or Metastatic Melanoma is a phase 1/2 interventional study registered as NCT06359860 by Beijing Scitech-Mq Pharmaceuticals Limited, with 64 participants planned, started 2023-11-07 and due to reach its primary completion in 2026-12. Interventions recorded: ST-1898 tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06359860","url":"https://clinicaltrials.gov/study/NCT06359860"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["beijing-scitech-mq-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06359860","phase":"1/2","setting":"A Phase Ib/II Study to Evaluate the Efficacy and Safety of ST-1898 in Subjects With Unresectable or Metastatic Melanoma","sponsor":"Beijing Scitech-Mq Pharmaceuticals Limited","started":"2023-11-07","startedType":"actual","enrolled":64,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05710848","kind":"trial","name":"A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer","aka":[],"tldr":"A phase 1/2 trial of STM-416 in bladder & urothelial cancer, run by SURGE Therapeutics, now recruiting.","summary":"A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer is a phase 1/2 interventional study registered as NCT05710848 by SURGE Therapeutics, with 75 participants planned, started 2023-07-11 and due to reach its primary completion in 2026-05. Interventions recorded: STM-416.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05710848","url":"https://clinicaltrials.gov/study/NCT05710848"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05710848","phase":"1/2","setting":"A Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder Cancer","sponsor":"SURGE Therapeutics","started":"2023-07-11","startedType":"actual","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05722015","kind":"trial","name":"A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)","aka":[],"tldr":"A phase 3 trial of Pemetrexed, Cisplatin, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77) is a phase 3 interventional study registered as NCT05722015 by Merck Sharp & Dohme LLC, with 377 participants enrolled, started 2023-02-14 and due to reach its primary completion in 2024-07-12. Interventions recorded: Pembrolizumab Formulated with Berahyaluronidase Alfa, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel. Conditions listed: Metastatic Non-small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05722015","url":"https://clinicaltrials.gov/study/NCT05722015"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pemetrexed","cisplatin","carboplatin","paclitaxel","pembrolizumab","filgrastim"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05722015-ann-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05722015","phase":"3","setting":"A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer","sponsor":"Merck Sharp & Dohme LLC","started":"2023-02-14","startedType":"actual","yearReported":2025,"enrolled":377,"enrolledBasis":"registry","outcomes":[{"endpoint":"Cycle 1: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab After the First Dose","primary":true,"unit":"μg·day/ml","arms":[{"name":"Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy","n":245,"value":1633.24,"note":"geometric CV 40.41%; Figures from the ClinicalTrials.gov results section (first posted 2025-07-28), not from a publication"},{"name":"Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy","n":126,"value":1437.58,"note":"geometric CV 26.23%"}],"p":"<0.00001","source":"https://clinicaltrials.gov/study/NCT05722015?tab=results"}]},{"id":"nct06212752","kind":"trial","name":"A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension","aka":[],"tldr":"A phase 3 trial of Pemetrexed, Cisplatin, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension is a phase 3 interventional study registered as NCT06212752 by Merck Sharp & Dohme LLC, with 39 participants enrolled, started 2023-06-13 and due to reach its primary completion in 2024-11-06. Interventions recorded: Pembrolizumab Formulated with Berahyaluronidase Alfa, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel. Conditions listed: Metastatic Non-small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06212752","url":"https://clinicaltrials.gov/study/NCT06212752"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pemetrexed","cisplatin","carboplatin","paclitaxel","pembrolizumab","filgrastim"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06212752","phase":"3","setting":"A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer","sponsor":"Merck Sharp & Dohme LLC","started":"2023-06-13","startedType":"actual","yearReported":2025,"enrolled":39,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy","n":28,"value":64.3,"note":"95% CI 44.1 to 81.4; Figures from the ClinicalTrials.gov results section (first posted 2025-11-12), not from a publication"},{"name":"Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy","n":11,"value":18.2,"note":"95% CI 2.3 to 51.8"}],"source":"https://clinicaltrials.gov/study/NCT06212752?tab=results"}]},{"id":"nct04521231","kind":"trial","name":"A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL","aka":[],"tldr":"A phase 1/2 trial of Blinatumomab in acute lymphoblastic leukaemia, run by Amgen, active and no longer recruiting.","summary":"A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL is a phase 1/2 interventional study registered as NCT04521231 by Amgen, with 181 participants enrolled, started 2021-01-04 and due to reach its primary completion in 2027-11-24. Interventions recorded: Blinatumomab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04521231","url":"https://clinicaltrials.gov/study/NCT04521231"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["blinatumomab"],"companies":["amgen","beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04521231","phase":"1/2","setting":"A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) and Minimal Residual Disease Positive (MRD+) B-ALL","sponsor":"Amgen","started":"2021-01-04","startedType":"actual","enrolled":181,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07134088","kind":"trial","name":"A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia","aka":[],"tldr":"A phase 1/2 trial of Blinatumomab in acute lymphoblastic leukaemia, run by Amgen, active and no longer recruiting.","summary":"A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia is a phase 1/2 interventional study registered as NCT07134088 by Amgen, with 104 participants enrolled, started 2025-12-08 and due to reach its primary completion in 2028-12-05. Interventions recorded: Blinatumomab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07134088","url":"https://clinicaltrials.gov/study/NCT07134088"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","all-paediatric-relapsed"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["blinatumomab"],"companies":["amgen","beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07134088","phase":"1/2","setting":"A Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of Administration of Subcutaneous (SC) Blinatumomab in Pediatric Participants With Relapsed/Refractory (R/R) and Minimal Residual Disease Positive (MRD+) B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)","sponsor":"Amgen","started":"2025-12-08","startedType":"actual","enrolled":104,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05625399","kind":"trial","name":"A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma","aka":["RELATIVITY-127"],"tldr":"A phase 3 trial of Nivolumab, Relatlimab + nivolumab in melanoma, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma is a phase 3 interventional study registered as NCT05625399 by Bristol-Myers Squibb, with 579 participants enrolled, started 2023-03-06 and due to reach its primary completion in 2025-08-04. Interventions recorded: Nivolumab + Relatlimab, rHuPH20. Conditions listed: Melanoma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05625399","url":"https://clinicaltrials.gov/study/NCT05625399"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","relatlimab-nivolumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05625399","phase":"3","setting":"A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma","sponsor":"Bristol-Myers Squibb","started":"2023-03-06","startedType":"actual","yearReported":2026,"enrolled":579,"enrolledBasis":"registry","outcomes":[{"endpoint":"Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale","primary":true,"unit":"ug/ml","arms":[{"name":"Nivo + Rela FDC SC","n":283,"value":4.141,"note":"SE 0.0167; Figures from the ClinicalTrials.gov results section (first posted 2026-08-26), not from a publication"},{"name":"Nivo + Rela FDC IV","n":291,"value":3.901,"note":"SE 0.0164"}],"source":"https://clinicaltrials.gov/study/NCT05625399?tab=results"},{"endpoint":"Progression Free Survival Per BICR","unit":"months","arms":[{"name":"Nivo + Rela FDC SC","n":286,"value":12.65,"note":"95% CI 8.08 to NA; Figures from the ClinicalTrials.gov results section (first posted 2026-08-26), not from a publication"},{"name":"Nivo + Rela FDC IV","n":292,"value":14.98,"note":"95% CI 12.12 to NA"}],"source":"https://clinicaltrials.gov/study/NCT05625399?tab=results"},{"endpoint":"Disease Control Rate (ORR) Per BICR","unit":"%","arms":[{"name":"Nivo + Rela FDC SC","n":286,"value":62.2,"note":"95% CI 56.3 to 67.9; Figures from the ClinicalTrials.gov results section (first posted 2026-08-26), not from a publication"},{"name":"Nivo + Rela FDC IV","n":292,"value":72.3,"note":"95% CI 66.7 to 77.3"}],"source":"https://clinicaltrials.gov/study/NCT05625399?tab=results"}]},{"id":"nct04810078","kind":"trial","name":"A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advance","aka":["CheckMate-67T"],"tldr":"A phase 3 trial of Nivolumab in renal cell carcinoma, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread is a phase 3 interventional study registered as NCT04810078 by Bristol-Myers Squibb, with 681 participants enrolled, started 2021-05-21 and due to reach its primary completion in 2025-07-29. Interventions recorded: Nivolumab and rHuPH20, Nivolumab. Conditions listed: Clear Cell Renal Cell Carcinoma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04810078","url":"https://clinicaltrials.gov/study/NCT04810078"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc","clear-cell-rcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04810078","phase":"3","setting":"A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy","sponsor":"Bristol-Myers Squibb","started":"2021-05-21","startedType":"actual","yearReported":2026,"enrolled":681,"enrolledBasis":"registry","outcomes":[{"endpoint":"Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale","primary":true,"unit":"μg/ml","arms":[{"name":"Nivolumab SC","n":242,"value":77.373,"note":"90% CI 74.555 to 80.297; Figures from the ClinicalTrials.gov results section (first posted 2026-09-22), not from a publication"},{"name":"Nivolumab IV","n":245,"value":36.875,"note":"90% CI 35.565 to 38.235"},{"name":"Nivo SC Process C","n":93,"value":75.504,"note":"90% CI 70.941 to 80.361"},{"name":"Nivo SC Process D","n":93,"value":75.596,"note":"90% CI 71.019 to 80.468"}],"source":"https://clinicaltrials.gov/study/NCT04810078?tab=results"},{"endpoint":"Objective Response Rate (ORR) Per BICR","unit":"%","arms":[{"name":"Nivolumab SC","n":248,"value":24.2,"note":"95% CI 19.0 to 30.0; Figures from the ClinicalTrials.gov results section (first posted 2026-09-22), not from a publication"},{"name":"Nivolumab IV","n":247,"value":18.2,"note":"95% CI 13.6 to 23.6"}],"source":"https://clinicaltrials.gov/study/NCT04810078?tab=results"}]},{"id":"nct06508658","kind":"trial","name":"A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcita","aka":["EPCORE DLBCL-4"],"tldr":"A phase 3 trial of Epcoritamab, Rituximab, Lenalidomide in diffuse large b-cell lymphoma, run by Genmab, active and no longer recruiting.","summary":"A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma is a phase 3 interventional study registered as NCT06508658 by Genmab, with 379 participants enrolled, started 2024-08-13 and due to reach its primary completion in 2028-03. Interventions recorded: Epcoritamab, Rituximab, Lenalidomide, Oxaliplatin, Gemcitabine. Conditions listed: Diffuse Large B-Cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06508658","url":"https://clinicaltrials.gov/study/NCT06508658"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","protac-degrader","t-cell-engager"],"targets":[],"drugs":["epcoritamab","rituximab","lenalidomide","capox","gemcitabine"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06508658","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","sponsor":"Genmab","started":"2024-08-13","startedType":"actual","enrolled":379,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06549595","kind":"trial","name":"A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients","aka":["SOUNDTRACK-F1"],"tldr":"A phase 3 trial of AZD0486 in follicular lymphoma, run by AstraZeneca, now recruiting.","summary":"A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients is a phase 3 interventional study registered as NCT06549595 by AstraZeneca, with 1018 participants planned, started 2024-08-07 and due to reach its primary completion in 2031-11-26. Interventions recorded: Surovatamig, R-CHOP, R-CVP, BR. Conditions listed: Untreated Follicular Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06549595","url":"https://clinicaltrials.gov/study/NCT06549595"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["azd0486"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06549595","phase":"3","setting":"A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 Plus Rituximab Versus Chemotherapy Plus Rituximab in Previously Untreated Participants With Follicular Lymphoma (SOUNDTRACK-F1)","sponsor":"AstraZeneca","started":"2024-08-07","startedType":"actual","enrolled":1018,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06254599","kind":"trial","name":"A Study Of SY-3505 Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Shouyao Holdings (Beijing) Co. LTD, not yet recruiting.","summary":"A Study Of SY-3505 Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC is a phase 3, randomised interventional study registered as NCT06254599 by Shouyao Holdings (Beijing) Co. LTD, with a registry enrolment figure of 255 participants, started 2024-05-01 and due to reach its primary completion in 2026-05-01. Interventions recorded: SY-3505 Capsules; Crizotinib Capsules. Conditions listed: Non-small Cell Lung Cancer. Primary outcome: Progression-free survival (PFS) assessed by independent radiology review (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) criteria.. Lung eligibility wording from the registry: \"Histologically or cytologically diagnosed with stage IV or stage IIIB and IIIC NSCLC that cannot be cured by surgery or radiotherapy (as per the 8th edition of the International Association for the Study of Lung Cancer \\[IASLC\\] Lung Cancer Staging)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06254599","url":"https://clinicaltrials.gov/study/NCT06254599"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["alk-positive-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06254599","phase":"3","setting":"A Phase III Study to Evaluate and Compare the Efficacy and Safety of SY-3505 Versus Crizotinib in Treatment-Naive Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer","sponsor":"Shouyao Holdings (Beijing) Co. LTD","started":"2024-05-01","startedType":"estimated","enrolled":255,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06533644","kind":"trial","name":"A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer","aka":[],"tldr":"A phase 2 trial of Partial Oncolysis in prostate cancer, run by Syncromune, Inc., now recruiting.","summary":"A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer is a phase 2 interventional study registered as NCT06533644 by Syncromune, Inc., with 91 participants planned, started 2025-05-29 and due to reach its primary completion in 2028-04-14. Interventions recorded: Partial Oncolysis and SV-102.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06533644","url":"https://clinicaltrials.gov/study/NCT06533644"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06533644","phase":"2","setting":"A Phase 2a Multicenter, Dose-Escalation and Dose Optimization Study of SYNC-T Therapy SV-102 for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","sponsor":"Syncromune, Inc.","started":"2025-05-29","startedType":"actual","enrolled":91,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07256509","kind":"trial","name":"A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous No","aka":[],"tldr":"A phase 2 trial of SYS6010, osimertinib, pemetrexed, cisplatin and other drugs in lung cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd., not yet recruiting.","summary":"A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer is a phase 2, randomised interventional study registered as NCT07256509 by CSPC Megalith Biopharmaceutical Co.,Ltd., with a registry enrolment figure of 120 participants, started 2025-11-30 and due to reach its primary completion in 2026-11-30. Interventions recorded: SYS6010; Osimertinib; Pemetrexed; Cisplatin; Carboplatin. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Major Pathological Response (MPR) Rate; Pathological Complete Response (pCR) Rate; Downstaging from N2 to N0/N1 or N1 to N0 at the time of surgery. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07256509","url":"https://clinicaltrials.gov/study/NCT07256509"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","platinum"],"targets":[],"drugs":["sys6010","osimertinib","pemetrexed","cisplatin","carboplatin"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07256509","phase":"2","setting":"A Phase II Study to Evaluate the Safety and Efficacy of SYS6010 Combined With Osimertinib Versus Osimertinib as Neoadjuvant Therapy in Participants With Resectable Stage II-IIIB Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Positive","sponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","started":"2025-11-30","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07672223","kind":"trial","name":"A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC)","aka":[],"tldr":"A phase 3 trial of SYS6010, tislelizumab, toripalimab, durvalumab and other drugs in lung cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd., not yet recruiting.","summary":"A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC) is a phase 3, randomised interventional study registered as NCT07672223 by CSPC Megalith Biopharmaceutical Co.,Ltd., with a registry enrolment figure of 570 participants, started 2026-06-25 and due to reach its primary completion in 2029-09-30. Interventions recorded: SYS6010; Enlonstobart; Tislelizumab; Toripalimab ±+platinum-based doublet chemotherapy; Durvalumab; Pembrolizumab; Nivolumab. Conditions listed: Non-small Cell Lung Cancer. Primary outcome: Disease-Free Survival (DFS) assessed by the independent review committee (IRC). Lung eligibility wording from the registry: \"Histologically confirmed squamous or non-squamous NSCLC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07672223","url":"https://clinicaltrials.gov/study/NCT07672223"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sys6010","tislelizumab","toripalimab","durvalumab","pembrolizumab","nivolumab"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07672223","phase":"3","setting":"A Phase III, Randomized, Open-Label Study of SYS6010 in Combination With Anti-PD-(L)-1 Monoclonal Antibody Versus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy for Patients With Completely Resected Stage II-IIIB NSCLC Who Have No Actionable Genomic Alterations and Not Achieved a Major Pathological Response.","sponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","started":"2026-06-25","startedType":"estimated","enrolled":570,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06271837","kind":"trial","name":"A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors","aka":["DESTINY PanTumor03"],"tldr":"A phase 2 trial of Trastuzumab deruxtecan and Bevacizumab in gastric & gastro-oesophageal junction cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors is a phase 2 interventional study registered as NCT06271837 by AstraZeneca, with 127 participants enrolled, started 2024-02-22 and due to reach its primary completion in 2027-02-10. Interventions recorded: Trastuzumab deruxtecan and Bevacizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06271837","url":"https://clinicaltrials.gov/study/NCT06271837"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan","bevacizumab"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06271837","phase":"2","setting":"A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) as Monotherapy or in Combination With Anti-cancer Agents for the Treatment of Patients With Selected HER2-expressing Tumors (DESTINY PanTumor03)","sponsor":"AstraZeneca","started":"2024-02-22","startedType":"actual","enrolled":127,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04639219","kind":"trial","name":"A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations","aka":[],"tldr":"A phase 2 trial of Trastuzumab deruxtecan in melanoma, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations is a phase 2 interventional study registered as NCT04639219 by AstraZeneca, with 102 participants enrolled, started 2020-12-30 and due to reach its primary completion in 2023-01-25. Interventions recorded: Trastuzumab deruxtecan. Conditions listed: Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast. Results were posted on ClinicalTrials.gov in 2024; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04639219","url":"https://clinicaltrials.gov/study/NCT04639219"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04639219-lancet-oncol-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04639219","phase":"2","setting":"A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for the Treatment of Unresectable and/or Metastatic Solid Tumors Harboring HER2 Activating Mutations Regardless of Tumor Histology","sponsor":"AstraZeneca","started":"2020-12-30","startedType":"actual","yearReported":2024,"enrolled":102,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed Overall Response Rate (ORR) as Per RECIST v1.1 Using Independent Central Review (ICR)","primary":true,"unit":"%","arms":[{"name":"T-DXd","n":102,"value":29.4,"note":"95% CI 20.8 to 39.3; Figures from the ClinicalTrials.gov results section (first posted 2024-02-15), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04639219?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"T-DXd","n":102,"value":10.9,"note":"95% CI 8.3 to 14.9; Figures from the ClinicalTrials.gov results section (first posted 2024-02-15), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04639219?tab=results"}]},{"id":"nct06971614","kind":"trial","name":"A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC","aka":[],"tldr":"A phase 2 trial of T3011 in bladder & urothelial cancer, run by ImmVira Pharma Co. Ltd, now recruiting.","summary":"A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC is a phase 2 interventional study registered as NCT06971614 by ImmVira Pharma Co. Ltd, with 160 participants planned, started 2025-06-09 and due to reach its primary completion in 2028-12-31. Interventions recorded: T3011.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06971614","url":"https://clinicaltrials.gov/study/NCT06971614"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["t3011"],"companies":["immvira-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06971614","phase":"2","setting":"An Open-Label, International, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Intravesical T3011 Injection in Participants With BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) or BCG-Exposed, Chemotherapy-Unresponsive Intermediate /High-Risk NMIBC","sponsor":"ImmVira Pharma Co. Ltd","started":"2025-06-09","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06846671","kind":"trial","name":"A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors","aka":["CaDAnCe-302"],"tldr":"A phase 3 trial of Bendamustine, Idelalisib, Rituximab and Venetoclax in chronic lymphocytic leukaemia, run by BeOne Medicines, now recruiting.","summary":"A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors is a phase 3 interventional study registered as NCT06846671 by BeOne Medicines, with 250 participants planned, started 2025-04-10 and due to reach its primary completion in 2028-05-15. Interventions recorded: Tacabrutideg, Bendamustine, Idelalisib, Rituximab and Venetoclax.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06846671","url":"https://clinicaltrials.gov/study/NCT06846671"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll"],"sections":[],"technologies":["bcl2-inhibitors","cytotoxic-chemotherapy","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["bendamustine","idelalisib","rituximab","venetoclax"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06846671","phase":"3","setting":"A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors","sponsor":"BeOne Medicines","started":"2025-04-10","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04712643","kind":"trial","name":"A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma","aka":[],"tldr":"A phase 3 trial of Atezolizumab, Bevacizumab in hepatocellular carcinoma, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma is a phase 3 interventional study registered as NCT04712643 by Hoffmann-La Roche, with 342 participants enrolled, started 2021-03-12 and due to reach its primary completion in 2029-02-01. Interventions recorded: Atezolizumab, Becavizumab, Transarterial chemoembolization (TACE). Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04712643","url":"https://clinicaltrials.gov/study/NCT04712643"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["atezolizumab","bevacizumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04712643","phase":"3","setting":"A Phase III, Open-Label, Randomized Study of On-Demand TACE Combined With Atezolizumab Plus Bevacizumab (Atezo/Bev) or On-Demand TACE Alone in Patients With Untreated Heaptocellular Carcionma","sponsor":"Hoffmann-La Roche","started":"2021-03-12","startedType":"actual","enrolled":342,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05320692","kind":"trial","name":"A Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) in Patients With Incurable Hepatocellular Carcinoma","aka":[],"tldr":"A phase 3 trial of Camrelizumab, Rivoceranib in hepatocellular carcinoma, run by Jiangsu HengRui Medicine Co., Ltd., active and no longer recruiting.","summary":"A Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) in Patients With Incurable Hepatocellular Carcinoma is a phase 3 interventional study registered as NCT05320692 by Jiangsu HengRui Medicine Co., Ltd., with 423 participants enrolled, started 2022-08-09 and due to reach its primary completion in 2026-07-30. Interventions recorded: TACE+Camrelizumab+Apatinib mesylate, TACE. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05320692","url":"https://clinicaltrials.gov/study/NCT05320692"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-intermediate"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["camrelizumab","rivoceranib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05320692","phase":"3","setting":"A Phase III, Randomized, Open-Label, Multi-center Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) or TACE Alone in Patients With Incurable Hepatocellular Carcinoma","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2022-08-09","startedType":"actual","enrolled":423,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06456463","kind":"trial","name":"A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy","aka":["TRILLIUM"],"tldr":"A phase 2 trial of Tagraxofusp, Venetoclax and Azacitidine in acute myeloid leukaemia, run by Stemline Therapeutics, Inc., active and no longer recruiting.","summary":"A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy is a phase 2 interventional study registered as NCT06456463 by Stemline Therapeutics, Inc., with 85 participants enrolled, started 2025-01-14 and due to reach its primary completion in 2028-02-09. Interventions recorded: Tagraxofusp, Venetoclax and Azacitidine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06456463","url":"https://clinicaltrials.gov/study/NCT06456463"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-older-unfit"],"sections":[],"technologies":["bcl2-inhibitors","cytotoxic-chemotherapy","epigenetic-drugs","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["tagraxofusp","venetoclax","azacitidine"],"companies":["menarini"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06456463","phase":"2","setting":"A Phase II Multicenter Open-label Trial of Tagraxofusp (Tag) in Combination With Venetoclax and Azacitidine (Ven/Aza) in Adults With Previously Untreated CD123+ Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy","sponsor":"Stemline Therapeutics, Inc.","started":"2025-01-14","startedType":"actual","enrolled":85,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05020015","kind":"trial","name":"A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)","aka":[],"tldr":"A phase 2 trial of TAK-007 in non-Hodgkin lymphoma, run by Takeda, active and no longer recruiting.","summary":"A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) is a phase 2 interventional study registered as NCT05020015 by Takeda, with 27 participants enrolled, started 2021-11-12 and due to reach its primary completion in 2024-06-16. Interventions recorded: TAK-007 and Chemotherapy Agents. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05020015","url":"https://clinicaltrials.gov/study/NCT05020015"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05020015","phase":"2","setting":"A Phase 2, Open-label, Multicenter Study of the Safety and Efficacy of TAK-007 in Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma","sponsor":"Takeda","started":"2021-11-12","startedType":"actual","yearReported":2025,"enrolled":27,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Treatment Emergent Adverse Events (TEAEs)","primary":true,"unit":"participants","arms":[{"name":"Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells","n":3,"value":3,"note":"Figures from the ClinicalTrials.gov results section (first posted 2025-08-12), not from a publication"},{"name":"Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells","n":6,"value":6},{"name":"Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells","n":10,"value":10},{"name":"Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells","n":7,"value":7}],"source":"https://clinicaltrials.gov/study/NCT05020015?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells","n":3,"value":8.9,"note":"range 1.7 to 20.3; Figures from the ClinicalTrials.gov results section (first posted 2025-08-12), not from a publication"},{"name":"Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells","n":6,"note":"Median was not estimable due to insufficient number of participants with events."},{"name":"Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells","n":10,"value":8.4,"note":"range 0.9 to 11.2"},{"name":"Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells","n":7,"note":"Median was not estimable due to insufficient number of participants with events."}],"source":"https://clinicaltrials.gov/study/NCT05020015?tab=results"},{"endpoint":"Progression-free Survival (PFS) Per Investigator","unit":"months","arms":[{"name":"Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells","n":3,"value":0.95,"note":"range 0.85 to 1.02; Figures from the ClinicalTrials.gov results section (first posted 2025-08-12), not from a publication"},{"name":"Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells","n":6,"value":2.23,"note":"range 0.95 to 9.00"},{"name":"Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells","n":10,"value":2,"note":"range 0.03 to 5.55"},{"name":"Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells","n":7,"value":5.62,"note":"range 2.83 to 8.77"}],"source":"https://clinicaltrials.gov/study/NCT05020015?tab=results"}]},{"id":"nct07205718","kind":"trial","name":"A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of TAK-188 in advanced solid tumours, run by Takeda, now recruiting.","summary":"A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors is a phase 1/2 interventional study registered as NCT07205718 by Takeda, with 223 participants planned, started 2025-11-19 and due to reach its primary completion in 2028-12-26. Interventions recorded: TAK-188.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07205718","url":"https://clinicaltrials.gov/study/NCT07205718"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07205718","phase":"1/2","setting":"An Open-label, Dose Escalation and Expansion, Phase 1/2 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TAK- 188, an Anti-CCR8 Antibody-Drug- Conjugate, as a Single Agent in Adult Participants With Locally Advanced or Metastatic Solid Tumors","sponsor":"Takeda","started":"2025-11-19","startedType":"actual","enrolled":223,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07436728","kind":"trial","name":"A Study of TAK-505 in Adults With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of TAK-505 in advanced solid tumours, run by Takeda, now recruiting.","summary":"A Study of TAK-505 in Adults With Solid Tumors is a phase 1/2 interventional study registered as NCT07436728 by Takeda, with 151 participants planned, started 2026-05-11 and due to reach its primary completion in 2030-08-18. Interventions recorded: TAK-505.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07436728","url":"https://clinicaltrials.gov/study/NCT07436728"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07436728","phase":"1/2","setting":"A Phase 1/2 First-in-Human, Open-Label, Dose Escalation and Expansion Trial of TAK-505 Monotherapy in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","sponsor":"Takeda","started":"2026-05-11","startedType":"actual","enrolled":151,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02716116","kind":"trial","name":"A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of TAK-788 in non-small-cell lung cancer, run by Takeda, active and no longer recruiting.","summary":"A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT02716116 by Takeda, with 334 participants enrolled, started 2016-06-16 and due to reach its primary completion in 2026-10-31. Interventions recorded: TAK-788.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02716116","url":"https://clinicaltrials.gov/study/NCT02716116"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc","her2-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02716116-jama-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02716116","phase":"1/2","setting":"A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer","sponsor":"Takeda","started":"2016-06-16","startedType":"actual","enrolled":334,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06390995","kind":"trial","name":"A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Mirvetuximab soravtansine in ovarian cancer, run by Takeda, active and no longer recruiting.","summary":"A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors is a phase 1/2 interventional study registered as NCT06390995 by Takeda, with 28 participants enrolled, started 2024-05-20 and due to reach its primary completion in 2025-04-16. Interventions recorded: TAK-853. Conditions listed: Ovarian Cancer, Solid Tumors. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06390995","url":"https://clinicaltrials.gov/study/NCT06390995"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["mirvetuximab-soravtansine"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06390995","phase":"1/2","setting":"A Phase 1/2 Open-label Study to Evaluate The Safety, Tolerability, Efficacy And Pharmacokinetics of Mirvetuximab Soravtansine (TAK-853) in Japanese Patients With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors","sponsor":"Takeda","started":"2024-05-20","startedType":"actual","yearReported":2026,"enrolled":28,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase 2: Objective Response Rate (ORR) Assessed by Investigator With Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)","primary":true,"unit":"%","arms":[{"name":"Phase 2: TAK-853, 6 mg/kg","n":25,"value":44,"note":"90% CI 27.0 to 62.1; Figures from the ClinicalTrials.gov results section (first posted 2026-06-16), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT06390995?tab=results"}]},{"id":"hr-nmibc","kind":"trial","name":"A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)","aka":["SunRISe-3"],"tldr":"A phase 3 trial testing Cetrelimab in bladder & urothelial cancer, active and no longer recruiting.","summary":"A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC) is a phase 3 interventional study registered as NCT05714202, led by Janssen Research & Development, and active but no longer recruiting on the registry. Official title: A Phase 3, Open-Label, Multi-Center, Randomised Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer. Planned enrolment is 1135 participants (actual). The study started in 2023-03-23 and primary completion is expected in 2029-09-18. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05714202","url":"https://clinicaltrials.gov/study/NCT05714202"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cetrelimab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05714202","phase":"3","setting":"A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer","sponsor":"Janssen Research & Development","started":"2023-03-23","startedType":"actual","enrolled":1135,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04658862","kind":"trial","name":"A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder","aka":["SunRISe-2"],"tldr":"A phase 3 trial testing Cetrelimab in bladder & urothelial cancer, active and no longer recruiting.","summary":"A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder is a phase 3 interventional study registered as NCT04658862, led by Janssen Research & Development, and active but no longer recruiting on the registry. Official title: A Phase 3, Multi-centre, Randomised Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy. Planned enrolment is 518 participants (actual). The study started in 2020-12-07 and primary completion is expected in 2026-12-30. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04658862","url":"https://clinicaltrials.gov/study/NCT04658862"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cetrelimab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04658862","phase":"3","setting":"A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy","sponsor":"Janssen Research & Development","started":"2020-12-07","startedType":"actual","enrolled":518,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06211764","kind":"trial","name":"A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)","aka":["SunRISe-5"],"tldr":"A phase 3 trial of Gemcitabine intravesical system (TAR-200), Mitomycin C and Gemcitabine in bladder & urothelial cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG) is a phase 3 interventional study registered as NCT06211764 by Janssen Research & Development, LLC, with 272 participants enrolled, started 2024-04-09 and due to reach its primary completion in 2030-11-27. Interventions recorded: TAR-200, Mitomycin C and Gemcitabine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06211764","url":"https://clinicaltrials.gov/study/NCT06211764"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["bcg-and-intravesical-therapy"],"targets":[],"drugs":["tar-200","mitomycin","gemcitabine"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06211764","phase":"3","setting":"17000139BLC3004: 17000139BLC3004 [SunRISe-5] Ph III HR NMIBC BCG Exp/UR Pap (N=250)","sponsor":"Janssen Research & Development, LLC","started":"2024-04-09","startedType":"actual","enrolled":272,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05552222","kind":"trial","name":"A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal","aka":["MajesTEC-7"],"tldr":"A phase 3 trial of Teclistamab, Daratumumab, Lenalidomide in multiple myeloma, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma is a phase 3 interventional study registered as NCT05552222 by Janssen Research & Development, LLC, with 1590 participants planned, started 2022-10-25 and due to reach its primary completion in 2031-04-30. Interventions recorded: Teclistamab, Daratumumab, Lenalidomide, Dexamethasone, Talquetamab. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05552222","url":"https://clinicaltrials.gov/study/NCT05552222"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-transplant-ineligible"],"sections":[],"technologies":["antiemetic-therapy","monoclonal-antibody","protac-degrader","t-cell-engager"],"targets":[],"drugs":["teclistamab","daratumumab","lenalidomide","dexamethasone","talquetamab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05552222","phase":"3","setting":"A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy","sponsor":"Janssen Research & Development, LLC","started":"2022-10-25","startedType":"actual","enrolled":1590,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07259213","kind":"trial","name":"A Study of Terbium 161 (161Tb)-RAD402 in Participants With CRPC","aka":[],"tldr":"A phase 1/2 trial of 161Tb RAD402 in prostate cancer, run by Radiopharm Theranostics, Ltd, now recruiting.","summary":"A Study of Terbium 161 (161Tb)-RAD402 in Participants With CRPC is a phase 1/2 interventional study registered as NCT07259213 by Radiopharm Theranostics, Ltd, with 73 participants planned, started 2026-03-05 and due to reach its primary completion in 2028-11-30. Interventions recorded: 161Tb RAD402.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07259213","url":"https://clinicaltrials.gov/study/NCT07259213"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["radiopharm-theranostics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07259213","phase":"1/2","setting":"A Phase 1/2a Study to Evaluate the Safety, Tolerability, Whole-Body Distribution, and Preliminary Clinical Activity of 161Tb-RAD402, a Radiolabeled Anti-Kallikrein-Related Peptidase 3 (KLK3) Monoclonal Antibody Targeting Free Prostate-Specific Antigen, in Participants With Castration-Resistant Prostate Cancer (CRPC)","sponsor":"Radiopharm Theranostics, Ltd","started":"2026-03-05","startedType":"actual","enrolled":73,"enrolledBasis":"registry","outcomes":[]},{"id":"pik3ca-2","kind":"trial","name":"A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)","aka":["PIKALO-2"],"tldr":"A phase 3 trial testing Tersolisib in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) is a phase 3 interventional study registered as NCT07174336, led by Eli Lilly and with Pfizer, and recruiting on the registry. Official title: A Phase 2, Randomised, Open-Label Dose Optimization and Phase 3, Randomised, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2). Planned enrolment is 800 participants (estimated). The study started in 2025-12-22 and primary completion is expected in 2029-05. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07174336","url":"https://clinicaltrials.gov/study/NCT07174336"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["tersolisib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07174336","phase":"3","setting":"A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)","sponsor":"Eli Lilly and","started":"2025-12-22","startedType":"actual","enrolled":800,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06134375","kind":"trial","name":"A Study of Tetrathiomolybdate (TM) Plus Capecitabine","aka":[],"tldr":"A phase 1/2 trial of capecitabine and pembrolizumab in triple-negative breast cancer, run by Dartmouth-Hitchcock Medical Center, now recruiting.","summary":"A Study of Tetrathiomolybdate (TM) Plus Capecitabine is a phase 1/2, randomised interventional study registered as NCT06134375 by Dartmouth-Hitchcock Medical Center, with a registry enrolment figure of 204 participants, started 2024-11-26 and due to reach its primary completion in 2031-06-26. Interventions recorded: Tetrathiomolybdate; Capecitabine; Pembrolizumab. Conditions listed: Triple Negative Breast Cancer; Residual Disease. Triple-negative eligibility wording from the registry: \"Patients must have histologically confirmed breast malignancy that is Triple negative tumors as defined as ER and PR \\<1% and HER2 negative as per ASCO/CAP guidelines\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06134375","url":"https://clinicaltrials.gov/study/NCT06134375"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06134375","phase":"1/2","setting":"Novel Targeting of the Microenvironment to Decrease Metastatic Recurrence of High-Risk TNBC: A Randomized Phase II Study of Tetrathiomolybdate (TM) Plus Capecitabine in Patients With Breast Cancer at High Risk of Recurrence","sponsor":"Dartmouth-Hitchcock Medical Center","started":"2024-11-26","startedType":"actual","enrolled":204,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04586426","kind":"trial","name":"A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma","aka":["RedirecTT-1"],"tldr":"A phase 1/2 trial of Talquetamab, Teclistamab in multiple myeloma, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT04586426 by Janssen Research & Development, LLC, with 228 participants enrolled, started 2020-12-15 and due to reach its primary completion in 2025-03-18. Interventions recorded: Talquetamab, Teclistamab. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04586426","url":"https://clinicaltrials.gov/study/NCT04586426"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["talquetamab","teclistamab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04586426","phase":"1/2","setting":"A Phase 1b/2 Dose Escalation and Expansion Study of the Combination of the Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma","sponsor":"Janssen Research & Development, LLC","started":"2020-12-15","startedType":"actual","enrolled":228,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07740720","kind":"trial","name":"A Study of the Duration of Dostarlimab in Untreated Mismatch Repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H) Locally Advanced Rectal Cancer","aka":["DuraSTAR"],"tldr":"A phase 3 trial of dostarlimab in colorectal cancer, run by GlaxoSmithKline, not yet recruiting.","summary":"A Study of the Duration of Dostarlimab in Untreated Mismatch Repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H) Locally Advanced Rectal Cancer is a phase 3, interventional study registered as NCT07740720 by GlaxoSmithKline, with a registry enrolment figure of 90 participants, started 2026-09-17 and due to reach its primary completion in 2029-12-12. Interventions recorded: Dostarlimab. Conditions listed: Neoplasms, Rectal. Primary outcome: Percentage of participants who achieve clinical complete response (cCR) amongst participants who receive > 9 cycles (> 6 months) of dostarlimab monotherapy by investigator assessment. Colorectal eligibility wording from the registry: \"* Has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+) locally advanced rectal adenocarcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07740720","url":"https://clinicaltrials.gov/study/NCT07740720"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07740720","phase":"3","setting":"A Phase 3b, Open-label Study Investigating the Duration of Neoadjuvant Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer","sponsor":"GlaxoSmithKline","started":"2026-09-17","startedType":"estimated","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05968326","kind":"trial","name":"A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC","aka":["IMCODE003"],"tldr":"A phase 2 trial of Autogene cevumeran and Atezolizumab in pancreatic ductal adenocarcinoma, run by Genentech, Inc., active and no longer recruiting.","summary":"A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC is a phase 2 interventional study registered as NCT05968326 by Genentech, Inc., with 260 participants enrolled, started 2023-10-18 and due to reach its primary completion in 2031-01-01. Interventions recorded: Autogene cevumeran, Atezolizumab and mFOLFIRINOX.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05968326","url":"https://clinicaltrials.gov/study/NCT05968326"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","neoantigen-mrna-vaccine"],"targets":[],"drugs":["autogene-cevumeran","atezolizumab"],"companies":["flatiron-health","biontech"],"institutions":[],"pathways":[],"terms":["pancreatic-trials-open-today"],"trials":["autogene-cevumeran-phase-1","amplify-7p"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["IMCODE003 (registry, 24 September 2026): randomised phase 2 of adjuvant autogene cevumeran with atezolizumab and modified FOLFIRINOX against modified FOLFIRINOX alone in resected pancreatic ductal adenocarcinoma, 260 participants (estimated), active but no longer recruiting, started 18 October 2023, primary completion (disease-free survival) January 2031; sites in ten countries. UK sites (8): Clatterbridge Liverpool, Belfast City Hospital, University Hospitals Birmingham, Addenbrooke's Cambridge, Barts Health, Guy's Hospital, Hammersmith (Imperial) and University College London Cancer Institute."],"nct":"NCT05968326","phase":"2","setting":"A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Patients With Resected Pancreatic Ductal Adenocarcinoma","sponsor":"Genentech, Inc.","started":"2023-10-18","startedType":"actual","enrolled":260,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07742215","kind":"trial","name":"A Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma (AMMADINA)","aka":["AMMADINA"],"tldr":"A phase 3 trial of Daratumumab, Dexamethasone and Pomalidomide in multiple myeloma, run by Biocad, now recruiting.","summary":"A Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma (AMMADINA) is a phase 3 interventional study registered as NCT07742215 by Biocad, with 390 participants planned, started 2026-06-15 and due to reach its primary completion in 2028-07. Interventions recorded: BCD-248 + daratumumab and Daratumumab + pomalidomide + dexamethasone.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07742215","url":"https://clinicaltrials.gov/study/NCT07742215"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["daratumumab","dexamethasone","pomalidomide"],"companies":["biocad"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07742215","phase":"3","setting":"A Phase III Open-Label, Randomized Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab Versus Daratumumab, Pomalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma","sponsor":"Biocad","started":"2026-06-15","startedType":"actual","enrolled":390,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04481763","kind":"trial","name":"A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast","aka":[],"tldr":"A phase 1/2 trial of camrelizumab in triple-negative breast cancer, run by Jiangxi Provincial Cancer Hospital, now recruiting.","summary":"A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast is a phase 1/2, interventional study registered as NCT04481763 by Jiangxi Provincial Cancer Hospital, with a registry enrolment figure of 20 participants, started 2020-07-14 and due to reach its primary completion in 2024-08-30. Interventions recorded: Camrelizumab; radiotherapy. Conditions listed: Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Participants with a histological or cytological diagnosis of TNBC breast cancer , defined by ER \\<1%, PR \\<1% and HER2 negative on IHC and/or non-amplified by ISH by local lab testing\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04481763","url":"https://clinicaltrials.gov/study/NCT04481763"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["camrelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04481763","phase":"1/2","setting":"A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast","sponsor":"Jiangxi Provincial Cancer Hospital","started":"2020-07-14","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07015242","kind":"trial","name":"A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma","aka":["CAROLYN"],"tldr":"A phase 2 trial of Rituximab, Methotrexate, Procarbazine, Temozolomide, Lisocabtagene maraleucel and Fludarabine in non-Hodgkin lymphoma, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, now recruiting.","summary":"A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma is a phase 2 interventional study registered as NCT07015242 by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, with 65 participants planned, started 2025-11-06 and due to reach its primary completion in 2028-01-09. Interventions recorded: Rituximab, Methotrexate, Procarbazine, Temozolomide, Liso-cel and Fludarabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07015242","url":"https://clinicaltrials.gov/study/NCT07015242"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","primary-cns-lymphoma"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["rituximab","methotrexate","procarbazine","temozolomide","lisocabtagene-maraleucel","fludarabine"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07015242","phase":"2","setting":"The CAROLYN Trial: Lisocabtagene Maraleucel as First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients","sponsor":"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company","started":"2025-11-06","startedType":"actual","enrolled":65,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04488822","kind":"trial","name":"A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT","aka":[],"tldr":"A phase 3 trial of Pexidartinib in tenosynovial giant cell tumour, run by Daiichi Sankyo Co., Ltd., active and no longer recruiting.","summary":"A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT is a phase 3 interventional study registered as NCT04488822 by Daiichi Sankyo Co., Ltd., with 40 participants enrolled, started 2020-09-25 and due to reach its primary completion in 2021-10-27. Interventions recorded: Pexidartinib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04488822","url":"https://clinicaltrials.gov/study/NCT04488822"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tenosynovial-giant-cell-tumour"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["pexidartinib"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04488822","phase":"3","setting":"Multicenter, Single Arm Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With Tenosynovial Giant Cell Tumor","sponsor":"Daiichi Sankyo Co., Ltd.","started":"2020-09-25","startedType":"actual","yearReported":2023,"enrolled":40,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Response Rate (ORR) of Pexidartinib Based on RECIST 1.1 of Asian Participants With Symptomatic Tenosynovial Giant Cell Tumor (TGCT) at Week 25, ORR","primary":true,"unit":"participants","arms":[{"name":"Pexidartinib","n":40,"value":9,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-04-27), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04488822?tab=results"}]},{"id":"nct07386938","kind":"trial","name":"A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer","aka":[],"tldr":"A phase 3 trial testing RPH-051 in HR-positive / HER2-negative breast cancer and HER2-positive breast cancer, active and no longer recruiting.","summary":"A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer is a phase 3 interventional study registered as NCT07386938, led by R-Pharm, and active but no longer recruiting on the registry. Official title: International, Multicenter, Double-blind, Randomised, Comparative Study of Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® Drug Products Combined With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Metastatic or Locally Recurrent Unresectable Breast Cancer. Planned enrolment is 246 participants (estimated). The study started in 2024-08-09 and primary completion is expected in 2025-10-15. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07386938","url":"https://clinicaltrials.gov/study/NCT07386938"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["rph-051"],"companies":["r-pharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07386938","phase":"3","setting":"International, Multicenter, Double-blind, Randomized, Comparative Study of Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® Drug Products Combined With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Metastatic or Locally Recurrent Unresectable Breast Cancer","sponsor":"R-Pharm","started":"2024-08-09","startedType":"actual","enrolled":246,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05327530","kind":"trial","name":"A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)","aka":[],"tldr":"A phase 2 trial of Avelumab and Sacituzumab govitecan in bladder & urothelial cancer, run by EMD Serono Research & Development Institute, Inc., active and no longer recruiting.","summary":"A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley) is a phase 2 interventional study registered as NCT05327530 by EMD Serono Research & Development Institute, Inc., with 256 participants enrolled, started 2022-08-17 and due to reach its primary completion in 2025-06-20. Interventions recorded: Avelumab, Sacituzumab Govitecan (SG), M6223, NKTR-255 and JB100. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05327530","url":"https://clinicaltrials.gov/study/NCT05327530"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["avelumab","sacituzumab-govitecan"],"companies":["merck-kgaa"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05327530","phase":"2","setting":"A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination With Other AntiTumor Agents as a Maintenance Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress With First Line Platinum-Containing Chemotherapy (JAVELIN Bladder Medley)","sponsor":"EMD Serono Research & Development Institute, Inc.","started":"2022-08-17","startedType":"actual","yearReported":2026,"enrolled":256,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])","primary":true,"unit":"months","arms":[{"name":"Avelumab + Sacituzumab Govitecan (SG)","n":74,"value":11.17,"note":"95% CI 7.62 to 17.64; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication"},{"name":"Avelumab + JB100 (NCT02603432)","n":74,"value":3.75,"note":"95% CI 3.32 to 5.65"}],"hr":0.54,"ci":[0.36,0.81],"source":"https://clinicaltrials.gov/study/NCT05327530?tab=results"},{"endpoint":"Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + M6223 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])","primary":true,"unit":"months","arms":[{"name":"Avelumab + M6223","n":72,"value":5.42,"note":"95% CI 3.78 to 7.43; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication"},{"name":"Avelumab + JB100 (NCT02603432)","n":74,"value":4.5,"note":"95% CI 3.45 to 7.20"}],"hr":0.95,"ci":[0.64,1.39],"source":"https://clinicaltrials.gov/study/NCT05327530?tab=results"},{"endpoint":"Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + NKTR-255 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])","primary":true,"unit":"months","arms":[{"name":"Avelumab + NKTR-255","n":73,"value":5.59,"note":"95% CI 3.75 to 12.91; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication"},{"name":"Avelumab + JB100 (NCT02603432)","n":74,"value":4.5,"note":"95% CI 3.48 to 7.20"}],"hr":0.81,"ci":[0.55,1.21],"source":"https://clinicaltrials.gov/study/NCT05327530?tab=results"},{"endpoint":"Overall Survival (OS) -Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])","unit":"months","arms":[{"name":"Avelumab + Sacituzumab Govitecan (SG)","n":24,"note":"NA signifies median and upper limit of 95% CI could not be estimated due to small number of death events.; Figures from the ClinicalTrials.gov results section (first posted 2026-09-01), not from a publication"},{"name":"Avelumab + JB100 (NCT02603432)","n":40,"value":22.05,"note":"95% CI 16.92 to 28.78"}],"hr":0.69,"ci":[0.41,1.17],"source":"https://clinicaltrials.gov/study/NCT05327530?tab=results"}]},{"id":"nct05635708","kind":"trial","name":"A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Tislelizumab, Carboplatin, Cisplatin in non-small-cell lung cancer and small-cell lung cancer, run by BeiGene, active and no longer recruiting.","summary":"A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT05635708 by BeiGene, with 400 participants planned, started 2023-03-07 and due to reach its primary completion in 2025-12-31. Interventions recorded: Tislelizumab, BGB-A445, LBL-007, Carboplatin, Cisplatin. Conditions listed: Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05635708","url":"https://clinicaltrials.gov/study/NCT05635708"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab","carboplatin","cisplatin","pemetrexed","paclitaxel"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05635708","phase":"2","setting":"Master Protocol: A Phase 2, Open-label, Multi-arm Study of Tislelizumab in Combination With Investigational Agents With or Without Chemotherapy in Patients With Previously Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer","sponsor":"BeiGene","started":"2023-03-07","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03933735","kind":"trial","name":"A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 1/2 trial of TNB-383B in multiple myeloma, run by AbbVie, active and no longer recruiting.","summary":"A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT03933735 by AbbVie, with 220 participants enrolled, started 2019-06-24 and due to reach its primary completion in 2026-05. Interventions recorded: TNB-383B.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03933735","url":"https://clinicaltrials.gov/study/NCT03933735"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03933735","phase":"1/2","setting":"A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-383B, a Bispecific Antibody Targeting BCMA in Subjects With Relapsed or Refractory Multiple Myeloma","sponsor":"AbbVie","started":"2019-06-24","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05852691","kind":"trial","name":"A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of Pembrolizumab in triple-negative breast cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer is a phase 2 interventional study registered as NCT05852691 by Hoffmann-La Roche, with 83 participants enrolled, started 2023-07-18 and due to reach its primary completion in 2026-10-19. Interventions recorded: Tobemstomig, Pembrolizumab and Nab-Paclitaxel.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05852691","url":"https://clinicaltrials.gov/study/NCT05852691"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05852691","phase":"2","setting":"A Phase II, Multicenter, Randomized, Double-Blind Study of Tobemstomig/RO7247669 Combined With Nab-Paclitaxel Compared With Pembrolizumab Combined With Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer","sponsor":"Hoffmann-La Roche","started":"2023-07-18","startedType":"actual","enrolled":83,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07439653","kind":"trial","name":"A Study of TORL-5-700 in Relapsed/Refractory Non Hodgkin's Lymphoma","aka":[],"tldr":"A phase 1/2 trial of TORL-5-700 in non-Hodgkin lymphoma, run by TORL Biotherapeutics, LLC, now recruiting.","summary":"A Study of TORL-5-700 in Relapsed/Refractory Non Hodgkin's Lymphoma is a phase 1/2 interventional study registered as NCT07439653 by TORL Biotherapeutics, LLC, with 155 participants planned, started 2026-03-31 and due to reach its primary completion in 2029-03-31. Interventions recorded: TORL-5-700, TORL-5-700 at MTD/RP2D and TORL-5-700 at MTD/RP2D in combination with another agent.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07439653","url":"https://clinicaltrials.gov/study/NCT07439653"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["torl-biotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07439653","phase":"1/2","setting":"A Phase 1/2, First-in-Human, Open-Label, Multicenter Study of TORL-5-700 as a Monotherapy and in Combination for Participants With Relapsed or Refractory Non-Hodgkin Lymphoma","sponsor":"TORL Biotherapeutics, LLC","started":"2026-03-31","startedType":"actual","enrolled":155,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06431490","kind":"trial","name":"A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer","aka":[],"tldr":"A phase 1/2 trial of TQB2102 in biliary tract cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer is a phase 1/2 interventional study registered as NCT06431490 by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., with 102 participants planned, started 2024-07-22 and due to reach its primary completion in 2027-05. Interventions recorded: TQB2102 for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06431490","url":"https://clinicaltrials.gov/study/NCT06431490"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb2102"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06431490","phase":"1/2","setting":"A Study to Evaluate the Efficacy, Safety, and Immunogenicity of TQB2102 for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","started":"2024-07-22","startedType":"actual","enrolled":102,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04523272","kind":"trial","name":"A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer","aka":[],"tldr":"A phase 3 trial testing TQB2450 in renal cell carcinoma, active and no longer recruiting.","summary":"A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer is a phase 3 interventional study registered as NCT04523272, led by Chia Tai Tianqing Pharmaceutical, and active but no longer recruiting on the registry. Official title: A Randomised, Positive Parallel Controlled, Multicenter Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer. Planned enrolment is 528 participants (actual). The study started in 2020-08-25 and primary completion is expected in 2025-06. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04523272","url":"https://clinicaltrials.gov/study/NCT04523272"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb2450"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04523272","phase":"3","setting":"A Randomized, Positive Parallel Controlled, Multicenter Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer","sponsor":"Chia Tai Tianqing Pharmaceutical","started":"2020-08-25","startedType":"actual","enrolled":528,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06202261","kind":"trial","name":"A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of TQB2930, TQB3616, Fulvestrant, Capecitabine, Vinorelbine and Eribulin in advanced solid tumours, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., now recruiting.","summary":"A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer is a phase 1/2 interventional study registered as NCT06202261 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with 154 participants planned, started 2023-04-13 and due to reach its primary completion in 2026-12. Interventions recorded: TQB2930 for injection, Paclitaxel for injection (albumin-bound), TQB3616 capsule, Fulvestrant injection, Capecitabine tablets and Vinorelbine tartrate injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06202261","url":"https://clinicaltrials.gov/study/NCT06202261"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb2930","tqb3616","fulvestrant","capecitabine","vinorelbine","eribulin"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06202261","phase":"1/2","setting":"A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of TQB2930 for Injection Monotherapy or in Combination for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Recurrent / Metastatic Breast Cancer","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2023-04-13","startedType":"actual","enrolled":154,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07691489","kind":"trial","name":"A Study of Trastuzumab Deruxtecan (T-DXd) and Cetuximab in People With Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Memorial Sloan Kettering Cancer Center, not yet recruiting.","summary":"A Study of Trastuzumab Deruxtecan (T-DXd) and Cetuximab in People With Colorectal Cancer is a phase 2, interventional study registered as NCT07691489 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 27 participants, started 2026-08 and due to reach its primary completion in 2029-06. Interventions recorded: Fam-Trastuzumab Deruxtecan-Nxki. Conditions listed: Colorectal Cancer; Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum. Primary outcome: Overall Response Rate (ORR). Colorectal eligibility wording from the registry: \"* Have histologically confirmed adenocarcinoma of the colon or rectum that is metastatic and/or unresectable\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07691489","url":"https://clinicaltrials.gov/study/NCT07691489"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","her2-amplified-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07691489","phase":"2","setting":"A Phase 2 Trial of Trastuzumab Deruxtecan in Combination With Cetuximab in HER2-low Metastatic Colorectal Cancer That Has Progressed on Standard Therapies","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2026-08","startedType":"estimated","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07428044","kind":"trial","name":"A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer","aka":["HERCULES"],"tldr":"A phase 2 trial of trastuzumab deruxtecan in lung cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer is a phase 2, interventional study registered as NCT07428044 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 14 participants, started 2026-02-13 and due to reach its primary completion in 2027-02-13. Interventions recorded: Trastuzumab Deruxtecan. Conditions listed: Non-Small Cell Lung Cancer; Non-small Cell Lung Cancer Stage II; Non-Small Cell Lung Cancer Stage IIIA; Non-Small Cell Lung Cancer Stage IIIB. Primary outcome: Major Pathologic Response/MPR Rate. Lung eligibility wording from the registry: \"* Pathologically documented NSCLC\". Sites: Canada, United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07428044","url":"https://clinicaltrials.gov/study/NCT07428044"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["her2-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07428044","phase":"2","setting":"A Phase II Trial of Neoadjuvant Trastuzumab Deruxtecan for Patients With Stage II-III HER2-Amplified or HER2-Mutated Non-Small Cell Lung Cancer (HERCULES)","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2026-02-13","startedType":"actual","enrolled":14,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07679360","kind":"trial","name":"A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer","aka":[],"tldr":"A phase 3 trial of Trastuzumab, Trastuzumab rezetecan, Adebrelimab, Capecitabine and Pembrolizumab in triple-negative breast cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer is a phase 3 interventional study registered as NCT07679360 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 1000 participants planned, started 2026-09-02 and due to reach its primary completion in 2030-12. Interventions recorded: Trastuzumab Rezetecan for Injection, Adebrelimab Injection, Capecitabine tablets and Pembrolizumab injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07679360","url":"https://clinicaltrials.gov/study/NCT07679360"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["adc","checkpoint-inhibitor","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab","trastuzumab-rezetecan","adebrelimab","capecitabine","pembrolizumab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07679360","phase":"3","setting":"A Phase III, Multicenter, Randomized, Open-Label Parallel-Controlled Study of Trastuzumab Rezetecan (SHR-A1811) in Combination With Adebrelimab (SHR-1316) Versus Investigator's Choice of Therapy in Subjects With Primary Triple Negative Breast Cancer Who Have Residual Invasive Disease Following Neoadjuvant Therapy","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2026-09-02","startedType":"actual","enrolled":1000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07567521","kind":"trial","name":"A Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive mCRPC","aka":[],"tldr":"A phase 1/2 trial of Radiopharmaceuticals in prostate cancer, run by C Ray Therapeutics, now recruiting.","summary":"A Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive mCRPC is a phase 1/2 interventional study registered as NCT07567521 by C Ray Therapeutics, with 90 participants planned, started 2026-05-22 and due to reach its primary completion in 2027-12-30. Interventions recorded: Radiopharmaceuticals.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07567521","url":"https://clinicaltrials.gov/study/NCT07567521"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":["psma"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07567521","phase":"1/2","setting":"A Prospective, Open-label, Randomized, Phase 1/2 Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)","sponsor":"C Ray Therapeutics","started":"2026-05-22","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05382338","kind":"trial","name":"A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss","aka":[],"tldr":"A phase 3 trial of Cisplatin, Cyclophosphamide, Lomustine, Sodium thiosulfate and Vincristine in Medulloblastoma, run by Children's Oncology Group, now recruiting.","summary":"A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss is a phase 3 interventional study registered as NCT05382338 by Children's Oncology Group, with 225 participants planned, started 2023-02-20 and due to reach its primary completion in 2029-12-31. Interventions recorded: Audiometric Test, Auditory Brainstem Response, Biospecimen Collection, Cisplatin, Cyclophosphamide, Lomustine, Magnetic Resonance Imaging, Quality-of-Life Assessment, Radiation Therapy, Sodium Thiosulfate, Survey Administration, Vincristine. Conditions recorded: Childhood Medulloblastoma.\n\nLinked to the drug Sodium thiosulfate because the registry names it among its interventions and Medulloblastoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05382338","url":"https://clinicaltrials.gov/study/NCT05382338"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["medulloblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":["cisplatin","cyclophosphamide","lomustine","sodium-thiosulfate","vincristine"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05382338","phase":"3","setting":"A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children With Average-Risk Medulloblastoma and Reduced Therapy in Children With Medulloblastoma With Low-Risk Features","sponsor":"Children's Oncology Group","started":"2023-02-20","startedType":"actual","enrolled":225,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06151262","kind":"trial","name":"A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, now recruiting.","summary":"A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT06151262 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, with a registry enrolment figure of 30 participants, started 2024-01-20 and due to reach its primary completion in 2025-05-28. Interventions recorded: Trilaciclib+mFOLFIRINOX. Conditions listed: Pancreatic Cancer. Primary outcome: Incidence of CIM. Pancreatic eligibility wording from the registry: \"* Patients with histologically or cytologically confirmed pancreatic cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06151262","url":"https://clinicaltrials.gov/study/NCT06151262"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06151262","phase":"2","setting":"A Single-arm, Exploratory Clinical Study of Trilaciclib Combined With mFOLFIRINOX Regimen in the Treatment of Patients With Advanced Pancreatic Cancer","sponsor":"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","started":"2024-01-20","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05423262","kind":"trial","name":"A Study of TRK-950 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of TRK-950, Nivolumab in melanoma, run by Toray Industries, Inc, now recruiting.","summary":"A Study of TRK-950 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05423262 by Toray Industries, Inc, with 49 participants planned, started 2022-07-06 and due to reach its primary completion in 2027-12. Interventions recorded: TRK-950, TRK-950, TRK-950, Nivolumab, TRK-950. Conditions listed: Solid Tumor, Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05423262","url":"https://clinicaltrials.gov/study/NCT05423262"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["trk-950","nivolumab"],"companies":["toray-industries"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05423262","phase":"1/2","setting":"A Phase I/II Study of TRK-950 in Patients With Advanced Solid Tumors","sponsor":"Toray Industries, Inc","started":"2022-07-06","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06038578","kind":"trial","name":"A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer","aka":[],"tldr":"A phase 2 trial of TRK-950 and Ramucirumab in gastric & gastro-oesophageal junction cancer, run by Toray Industries, Inc, now recruiting.","summary":"A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer is a phase 2 interventional study registered as NCT06038578 by Toray Industries, Inc, with 146 participants planned, started 2023-10-04 and due to reach its primary completion in 2026-06-30. Interventions recorded: TRK-950, Ramucirumab and Paclitaxel.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06038578","url":"https://clinicaltrials.gov/study/NCT06038578"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["trk-950","ramucirumab"],"companies":["toray-industries"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06038578","phase":"2","setting":"A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer","sponsor":"Toray Industries, Inc","started":"2023-10-04","startedType":"actual","enrolled":146,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06385925","kind":"trial","name":"A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation","aka":[],"tldr":"A phase 1/2 trial of TSN1611 in advanced solid tumours, run by Tyligand Pharmaceuticals (Suzhou) Limited, now recruiting.","summary":"A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation is a phase 1/2 interventional study registered as NCT06385925 by Tyligand Pharmaceuticals (Suzhou) Limited, with 440 participants planned, started 2024-04-29 and due to reach its primary completion in 2026-10-30. Interventions recorded: TSN1611.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06385925","url":"https://clinicaltrials.gov/study/NCT06385925"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["kras"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06385925","phase":"1/2","setting":"Phase 1/2 Study of TSN1611 in Subjects With Advanced Solid Tumors Harboring KRAS G12D Mutation","sponsor":"Tyligand Pharmaceuticals (Suzhou) Limited","started":"2024-04-29","startedType":"actual","enrolled":440,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05440708","kind":"trial","name":"A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab, Atezolizumab, Bevacizumab in hepatocellular carcinoma, run by Tvardi Therapeutics, Incorporated, now recruiting.","summary":"A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma is a phase 1/2 interventional study registered as NCT05440708 by Tvardi Therapeutics, Incorporated, with 193 participants planned, started 2023-03-23 and due to reach its primary completion in 2027-02-01. Interventions recorded: TTI-101, Pembrolizumab, Atezolizumab, Bevacizumab. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05440708","url":"https://clinicaltrials.gov/study/NCT05440708"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","atezolizumab","bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05440708","phase":"1/2","setting":"REVERT- Liver Cancer: A Phase 1b/2 Multicenter, Open-label Study to Evaluate the Safety and Efficacy of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma","sponsor":"Tvardi Therapeutics, Incorporated","started":"2023-03-23","startedType":"actual","enrolled":193,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04721977","kind":"trial","name":"A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001)","aka":[],"tldr":"A phase 2 trial of Tucatinib, Trastuzumab and Capecitabine in advanced solid tumours, run by Pfizer, active and no longer recruiting.","summary":"A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001) is a phase 2 interventional study registered as NCT04721977 by Pfizer, with 66 participants enrolled, started 2021-04-08 and due to reach its primary completion in 2023-07-17. Interventions recorded: Tucatinib, Trastuzumab and Capecitabine. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04721977","url":"https://clinicaltrials.gov/study/NCT04721977"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","her2-tyrosine-kinase-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["tucatinib","trastuzumab","capecitabine"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04721977","phase":"2","setting":"A Phase 2 Open-label, Single Arm Study of MK-7119 in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic HER2+ Breast Carcinoma","sponsor":"Pfizer","started":"2021-04-08","startedType":"actual","yearReported":2024,"enrolled":66,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed Objective Response Rate(cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Determined by Independent Central Review (ICR): Japanese Participants","primary":true,"unit":"%","arms":[{"name":"Tucatinib + Capecitabine + Trastuzumab","n":48,"value":35.4,"note":"90% CI 24.0 to 48.3; Figures from the ClinicalTrials.gov results section (first posted 2024-08-09), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04721977?tab=results"}]},{"id":"nct05672524","kind":"trial","name":"A Study of Tucatinib and Trastuzumab in People With Rectal Cancer","aka":[],"tldr":"A phase 2 trial of trastuzumab and tucatinib in colorectal cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"A Study of Tucatinib and Trastuzumab in People With Rectal Cancer is a phase 2, interventional study registered as NCT05672524 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 37 participants, started 2022-12-30 and due to reach its primary completion in 2027-07-30. Interventions recorded: Trastuzumab; Tucatinib. Conditions listed: Adenocarcinoma of the Rectum; Locally Advanced Rectal Adenocarcinoma; Rectal Adenocarcinoma; HER2 Positive Rectal Adenocarcinoma; Rectal Cancer. Primary outcome: Clinical complete response of study participants. Colorectal eligibility wording from the registry: \"* Histologically confirmed rectal adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05672524","url":"https://clinicaltrials.gov/study/NCT05672524"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","her2-amplified-colorectal"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["trastuzumab","tucatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05672524","phase":"2","setting":"A Phase II Study of Induction Tucatinib and Trastuzumab With Total Neoadjuvant Therapy for Locally Advanced HER2-amplified Rectal Adenocarcinoma","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2022-12-30","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06497985","kind":"trial","name":"A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients","aka":[],"tldr":"A phase 3 trial of Tucidinostat, Sintilimab, Bevacizumab in colorectal cancer, run by Chipscreen Biosciences, Ltd., now recruiting.","summary":"A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients is a phase 3 interventional study registered as NCT06497985 by Chipscreen Biosciences, Ltd., with 430 participants planned, started 2024-12-06 and due to reach its primary completion in 2028-05-31. Interventions recorded: Tucidinostat, Sintilimab, Bevacizumab, Fruquintinib. Conditions listed: Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06497985","url":"https://clinicaltrials.gov/study/NCT06497985"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["tucidinostat","sintilimab","bevacizumab","fruquintinib"],"companies":["chipscreen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06497985","phase":"3","setting":"A Randomised, Open-label, Multicenter Phase III Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients Who Failed at Least Second-line Standard Therapies","sponsor":"Chipscreen Biosciences, Ltd.","started":"2024-12-06","startedType":"actual","enrolled":430,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04104776","kind":"trial","name":"A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","aka":[],"tldr":"A phase 1/2 trial of Enzalutamide in diffuse large b-cell lymphoma and mesothelioma, run by Novartis Pharmaceuticals, now recruiting.","summary":"A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas is a phase 1/2 interventional study registered as NCT04104776 by Novartis Pharmaceuticals, with 300 participants planned, started 2019-09-18 and due to reach its primary completion in 2030-02-27. Interventions recorded: Tulmimetostat, Enzalutamide. Conditions listed: Advanced Solid Tumor, Diffuse Large B Cell Lymphoma, Lymphoma, T-Cell, Mesothelioma, Malignant. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04104776","url":"https://clinicaltrials.gov/study/NCT04104776"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl","mesothelioma","endometrial","prostate"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["enzalutamide"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04104776","phase":"1/2","setting":"A Phase 1/2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","sponsor":"Novartis Pharmaceuticals","started":"2019-09-18","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06672068","kind":"trial","name":"A Study of TY-9591 With Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor NSCLC","aka":[],"tldr":"A phase 2 trial of pemetrexed, cisplatin and carboplatin in lung cancer, run by TYK Medicines, Inc, not yet recruiting.","summary":"A Study of TY-9591 With Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor NSCLC is a phase 2, randomised interventional study registered as NCT06672068 by TYK Medicines, Inc, with a registry enrolment figure of 60 participants, started 2025-02-20 and due to reach its primary completion in 2027-12-01. Interventions recorded: TY-9591 80mg QD+pemetrexed+Cisplatin/Carboplatin; TY-9591 160mg QD+pemetrexed+Cisplatin/Carboplatin. Conditions listed: NSCLC. Primary outcome: ORR. Lung eligibility wording from the registry: \"Patients with non-squamous non-small cell lung cancer (NSCLC) diagnosed by histology or cytology as locally advanced (clinical stage IIIB, IIIC, no chance of radical surgery or radical chemoradiotherapy) or metastatic (clinical stage IVA, IVB) (according to the AJCC TNM staging criteria for lung can\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06672068","url":"https://clinicaltrials.gov/study/NCT06672068"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pemetrexed","cisplatin","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06672068","phase":"2","setting":"To Evaluate the Efficacy and Safety of TY-9591 Tablets Combined With Chemotherapy as First-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation","sponsor":"TYK Medicines, Inc","started":"2025-02-20","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04014205","kind":"trial","name":"A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies","aka":[],"tldr":"A phase 1/2 trial of Orelabrutinib in advanced solid tumours, run by Beijing InnoCare Pharma Tech Co., Ltd., active and no longer recruiting.","summary":"A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies is a phase 1/2 interventional study registered as NCT04014205 by Beijing InnoCare Pharma Tech Co., Ltd., with 81 participants enrolled, started 2019-11-18 and due to reach its primary completion in 2026-06-30. Interventions recorded: Orelabrutinib (ICP-022).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04014205","url":"https://clinicaltrials.gov/study/NCT04014205"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["orelabrutinib"],"companies":["innocare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04014205","phase":"1/2","setting":"A Phase I/II，Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","started":"2019-11-18","startedType":"actual","enrolled":81,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06644768","kind":"trial","name":"A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Daiichi Sankyo, active and no longer recruiting.","summary":"A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations is a phase 1/2 interventional study registered as NCT06644768 by Daiichi Sankyo, with 137 participants planned, started 2024-10-30 and due to reach its primary completion in 2028-03-30. Interventions recorded: valemetostat tosylate, pembrolizumab. Conditions listed: Non-small Cell Lung Cancer, Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06644768","url":"https://clinicaltrials.gov/study/NCT06644768"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06644768","phase":"1/2","setting":"A Multicenter, Randomized, Open-Label, Phase 1b/2 Trial Of Valemetostat Tosylate Plus Pembrolizumab Vs Pembrolizumab Alone in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1 With Tumor Proportion Score ≥50% Without Actionable Genomic Alterations","sponsor":"Daiichi Sankyo","started":"2024-10-30","startedType":"actual","enrolled":137,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06930794","kind":"trial","name":"A Study of Vebreltinib and Platinum-Containing Double Agents in Subjects With MET-Positive","aka":["KUNPENG-3"],"tldr":"A phase 3 trial of Vebreltinib in non-small-cell lung cancer, run by Beijing Pearl Biotechnology Limited Liability Company, now recruiting.","summary":"A Study of Vebreltinib and Platinum-Containing Double Agents in Subjects With MET-Positive is a phase 3 interventional study registered as NCT06930794 by Beijing Pearl Biotechnology Limited Liability Company, with 300 participants planned, started 2025-07-07 and due to reach its primary completion in 2029-02. Interventions recorded: Vebreltinib combined with platinum-based doublet chemotherapy. and platinum-based doublet chemotherapy..","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06930794","url":"https://clinicaltrials.gov/study/NCT06930794"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["vebreltinib"],"companies":["beijing-pearl-biotechnology-limited-liability-company"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06930794","phase":"3","setting":"An Open-label, Randomized, Controlled, Multicenter Phase IIIb Clinical Study to Evaluate the Efficacy and Safety of Vebreltinib Enteric Capsule Combined With Platinum-based Doublet Chemotherapy Compared With Platinum-based Doublet Chemotherapy in Subjects With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Not Received Previous Systemic Treatment and MET-Positive","sponsor":"Beijing Pearl Biotechnology Limited Liability Company","started":"2025-07-07","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07689201","kind":"trial","name":"A Study of Velzatinib in Participants With Metastatic and/or Unresectable GIST After Imatinib, Sunitinib, Regorafenib, and Pimitespib","aka":["StrateGIST J"],"tldr":"A phase 2 trial of Velzatinib in advanced solid tumours, run by GlaxoSmithKline, now recruiting.","summary":"A Study of Velzatinib in Participants With Metastatic and/or Unresectable GIST After Imatinib, Sunitinib, Regorafenib, and Pimitespib is a phase 2 interventional study registered as NCT07689201 by GlaxoSmithKline, with 24 participants planned, started 2026-08-17 and due to reach its primary completion in 2027-11-29. Interventions recorded: Velzatinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07689201","url":"https://clinicaltrials.gov/study/NCT07689201"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["velzatinib"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07689201","phase":"2","setting":"A Phase 2, Single-arm, Multicenter, Open-Label Study of Velzatinib (GSK6042981) in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib, Sunitinib, Regorafenib, and Pimitespib Therapies (StrateGIST J)","sponsor":"GlaxoSmithKline","started":"2026-08-17","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06115135","kind":"trial","name":"A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma","aka":[],"tldr":"A phase 2 trial of Venetoclax in multiple myeloma, run by Oncotherapeutics, now recruiting.","summary":"A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT06115135 by Oncotherapeutics, with 39 participants planned, started 2024-06-20 and due to reach its primary completion in 2026-04-30. Interventions recorded: Venetoclax. Conditions listed: Multiple Myeloma in Relapse, Multiple Myeloma, Refractory. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06115135","url":"https://clinicaltrials.gov/study/NCT06115135"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["venetoclax"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06115135","phase":"2","setting":"A Phase 2 Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma Patients With t(11;14)","sponsor":"Oncotherapeutics","started":"2024-06-20","startedType":"actual","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02966756","kind":"trial","name":"A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","aka":[],"tldr":"A phase 2 trial of Venetoclax in chronic lymphocytic leukaemia, run by AbbVie, active and no longer recruiting.","summary":"A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma is a phase 2 interventional study registered as NCT02966756 by AbbVie, with 66 participants enrolled, started 2017-10-12 and due to reach its primary completion in 2030-12. Interventions recorded: Venetoclax.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02966756","url":"https://clinicaltrials.gov/study/NCT02966756"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["venetoclax"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02966756","phase":"2","setting":"A Phase 2 Open-Label Study of the Efficacy of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","sponsor":"AbbVie","started":"2017-10-12","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07218380","kind":"trial","name":"A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract","aka":["FORAGER-2"],"tldr":"A phase 3 trial testing Vepugratinib in bladder & urothelial cancer, now recruiting.","summary":"A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract is a phase 3 interventional study registered as NCT07218380, led by Eli Lilly and, and recruiting on the registry. Official title: FORAGER-2: A Phase 3, Randomised, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration. Planned enrolment is 450 participants (estimated). The study started in 2025-12-12 and primary completion is expected in 2029-10. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07218380","url":"https://clinicaltrials.gov/study/NCT07218380"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["vepugratinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07218380","phase":"3","setting":"FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration","sponsor":"Eli Lilly and","started":"2025-12-12","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06943833","kind":"trial","name":"A Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (IVOLGA)","aka":["IVOLGA"],"tldr":"A phase 2 trial of Volrustomig in cervical cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (IVOLGA) is a phase 2 interventional study registered as NCT06943833 by AstraZeneca, with 37 participants enrolled, started 2025-03-31 and due to reach its primary completion in 2028-03-13. Interventions recorded: Volrustomig.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06943833","url":"https://clinicaltrials.gov/study/NCT06943833"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cervical","locally-advanced-cervical-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06943833","phase":"2","setting":"A Phase II Single-arm Multi-centre Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum Based, Concurrent Chemoradiation Therapy","sponsor":"AstraZeneca","started":"2025-03-31","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07699328","kind":"trial","name":"A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer","aka":["REACH-EGFR"],"tldr":"A phase 1/2 trial of VRN110755 in non-small-cell lung cancer and small-cell lung cancer, run by Voronoi, Inc, now recruiting.","summary":"A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT07699328 by Voronoi, Inc, with 315 participants planned, started 2024-03-26 and due to reach its primary completion in 2029-01-01. Interventions recorded: VRN110755. Conditions listed: EGFR-Mutant Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07699328","url":"https://clinicaltrials.gov/study/NCT07699328"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["vrn110755"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07699328","phase":"1/2","setting":"A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of VRN110755 in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Voronoi, Inc","started":"2024-03-26","startedType":"actual","enrolled":315,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07093814","kind":"trial","name":"A Study of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma","aka":[],"tldr":"A phase 1/2 trial of VRT106 in glioma & glioblastoma, run by Guangzhou Virotech Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma is a phase 1/2 interventional study registered as NCT07093814 by Guangzhou Virotech Pharmaceutical Co., Ltd., with 42 participants planned, started 2025-09-02 and due to reach its primary completion in 2028-12-31. Interventions recorded: VRT106.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07093814","url":"https://clinicaltrials.gov/study/NCT07093814"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["guangzhou-virotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07093814","phase":"1/2","setting":"A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma","sponsor":"Guangzhou Virotech Pharmaceutical Co., Ltd.","started":"2025-09-02","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07589257","kind":"trial","name":"A Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Diffuse Intrinsic Pontine Glioma","aka":[],"tldr":"A phase 2 trial of VRT106 for injection in glioma & glioblastoma and diffuse midline glioma, H3 K27-altered, run by Guangzhou Virotech Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Diffuse Intrinsic Pontine Glioma is a phase 2 interventional study registered as NCT07589257 by Guangzhou Virotech Pharmaceutical Co., Ltd., with 10 participants planned, started 2026-05-07 and due to reach its primary completion in 2028-06-30. Interventions recorded: VRT106 for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07589257","url":"https://clinicaltrials.gov/study/NCT07589257"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma","dipg-dmg"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["guangzhou-virotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07589257","phase":"2","setting":"A Single-Arm, Open-Label, Multicenter Phase II Clinical Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Including Diffuse Intrinsic Pontine Glioma","sponsor":"Guangzhou Virotech Pharmaceutical Co., Ltd.","started":"2026-05-07","startedType":"estimated","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06117566","kind":"trial","name":"A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Toripalimab in advanced solid tumours, run by Shanghai Jiatan Pharmatech Co., Ltd, now recruiting.","summary":"A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06117566 by Shanghai Jiatan Pharmatech Co., Ltd, with 100 participants planned, started 2022-11-18 and due to reach its primary completion in 2025-11-09. Interventions recorded: WX390 and Toripalimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06117566","url":"https://clinicaltrials.gov/study/NCT06117566"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":["shanghai-jiatan-pharmatech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06117566","phase":"1/2","setting":"A Phase Ib/IIa Study to Evaluate the Safety and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors","sponsor":"Shanghai Jiatan Pharmatech Co., Ltd","started":"2022-11-18","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06117540","kind":"trial","name":"A Study of WX390 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 2 trial of WX390 in advanced solid tumours, run by Shanghai Jiatan Pharmatech Co., Ltd, now recruiting.","summary":"A Study of WX390 in Patients With Advanced Solid Tumors is a phase 2 interventional study registered as NCT06117540 by Shanghai Jiatan Pharmatech Co., Ltd, with 70 participants planned, started 2021-05-11 and due to reach its primary completion in 2025-06-12. Interventions recorded: WX390.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06117540","url":"https://clinicaltrials.gov/study/NCT06117540"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shanghai-jiatan-pharmatech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06117540","phase":"2","setting":"An Open-label, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of WX390 in Patients With Advanced Solid Tumors","sponsor":"Shanghai Jiatan Pharmatech Co., Ltd","started":"2021-05-11","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07213674","kind":"trial","name":"A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate ","aka":[],"tldr":"A phase 3 trial of Xaluritamig, Abiraterone acetate, Docetaxel in prostate cancer, run by Amgen, now recruiting.","summary":"A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer is a phase 3 interventional study registered as NCT07213674 by Amgen, with 750 participants planned, started 2025-11-28 and due to reach its primary completion in 2030-01-07. Interventions recorded: Xaluritamig, Abiraterone acetate, Docetaxel, Cabazitaxel. Conditions listed: Metastatic Castration-resistant Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07213674","url":"https://clinicaltrials.gov/study/NCT07213674"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["xaluritamig","abiraterone","docetaxel","cabazitaxel"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07213674","phase":"3","setting":"A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","sponsor":"Amgen","started":"2025-11-28","startedType":"actual","enrolled":750,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05032040","kind":"trial","name":"A Study of XmAb20717 (Vudalimab)in Patients With Selected Advanced Gynecologic and Genitourinary Malignancies","aka":[],"tldr":"A phase 2 trial of vudalimab in ovarian cancer, endometrial cancer, cervical cancer and prostate cancer, run by Xencor, Inc., active and no longer recruiting.","summary":"A Study of XmAb20717 (Vudalimab)in Patients With Selected Advanced Gynecologic and Genitourinary Malignancies is a phase 2 interventional study registered as NCT05032040 by Xencor, Inc., with 170 participants enrolled, started 2022-07-21 and due to reach its primary completion in 2025-10-15. Interventions recorded: vudalimab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05032040","url":"https://clinicaltrials.gov/study/NCT05032040"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","endometrial","cervical","prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["vudalimab"],"companies":["xencor","icon-plc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05032040","phase":"2","setting":"A Phase 2 Study of XmAb20717 in Patients With Selected Gynecological Malignancies and Metastatic Castration-Resistant Prostate Cancer","sponsor":"Xencor, Inc.","started":"2022-07-21","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05077449","kind":"trial","name":"A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer","aka":[],"tldr":"A phase 3 trial testing XZP-3287 in HR-positive / HER2-negative breast cancer, active and no longer recruiting.","summary":"A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer is a phase 3 interventional study registered as NCT05077449, led by Xuanzhu Biopharmaceutical, and active but no longer recruiting on the registry. Official title: A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 in Combination With Fulvestrant Versus Placebo Combined With Fulvestrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer. Planned enrolment is 300 participants (estimated). The study started in 2021-11-16 and primary completion is expected in 2024-02-22. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05077449","url":"https://clinicaltrials.gov/study/NCT05077449"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["xzp-3287"],"companies":["xuanzhu-biopharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05077449-nat-commun-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05077449","phase":"3","setting":"A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 in Combination With Fulvestrant Versus Placebo Combined With Fulvestrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer","sponsor":"Xuanzhu Biopharmaceutical","started":"2021-11-16","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05257395","kind":"trial","name":"A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer","aka":[],"tldr":"A phase 3 trial of XZP-3287 in advanced solid tumours, run by Xuanzhu Biopharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer is a phase 3 interventional study registered as NCT05257395 by Xuanzhu Biopharmaceutical Co., Ltd., with 397 participants enrolled, started 2022-03-14 and due to reach its primary completion in 2025-12-05. Interventions recorded: XZP-3287+ Letrozole/Anastrozole and Placebo + Letrozole/Anastrozole.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05257395","url":"https://clinicaltrials.gov/study/NCT05257395"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["xzp-3287","anastrozole"],"companies":["xuanzhu-biopharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05257395","phase":"3","setting":"A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 Combined With Letrozole/Anastrozole Versus Placebo Combined With Letrozole/Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer","sponsor":"Xuanzhu Biopharmaceutical Co., Ltd.","started":"2022-03-14","startedType":"actual","enrolled":397,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04996121","kind":"trial","name":"A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of XZP-5955 tablets in non-small-cell lung cancer, run by Xuanzhu Biopharmaceutical Co., Ltd., now recruiting.","summary":"A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT04996121 by Xuanzhu Biopharmaceutical Co., Ltd., with 360 participants planned, started 2021-12-06 and due to reach its primary completion in 2025-09. Interventions recorded: XZP-5955 tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04996121","url":"https://clinicaltrials.gov/study/NCT04996121"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","ntrk-fusion-nsclc","ros1-positive-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["xuanzhu-biopharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04996121","phase":"1/2","setting":"The Safety Tolerability Pharmacokinetic Characteristics and Efficacy of XZP-5955 Tablets in Patients With NTRK or ROS1 Gene Fusion Locally Advanced or Metastatic Solid Tumors in a Single-arm Open-label Multi-center Phase I/II Clinical Study","sponsor":"Xuanzhu Biopharmaceutical Co., Ltd.","started":"2021-12-06","startedType":"actual","enrolled":360,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07208773","kind":"trial","name":"A Study of YL201 and Ivonescimab (AK112) in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of YL201, Ivonescimab in non-small-cell lung cancer and small-cell lung cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd., now recruiting.","summary":"A Study of YL201 and Ivonescimab (AK112) in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07208773 by MediLink Therapeutics (Suzhou) Co., Ltd., with 260 participants planned, started 2025-10-29 and due to reach its primary completion in 2027-01. Interventions recorded: YL201, Ivonescimab. Conditions listed: Advanced Solid Tumors, Non Small Cell Lung Cancer, Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07208773","url":"https://clinicaltrials.gov/study/NCT07208773"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["yl201","ivonescimab"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07208773","phase":"1/2","setting":"A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of YL201 in Combination With Ivonescimab in Patients With Advanced Solid Tumors","sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","started":"2025-10-29","startedType":"actual","enrolled":260,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07407933","kind":"trial","name":"A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of YL201 and Atezolizumab in small-cell lung cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd., now recruiting.","summary":"A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07407933 by MediLink Therapeutics (Suzhou) Co., Ltd., with 118 participants planned, started 2026-03-31 and due to reach its primary completion in 2028-11. Interventions recorded: YL201 and Atezolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07407933","url":"https://clinicaltrials.gov/study/NCT07407933"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["yl201","atezolizumab"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07407933","phase":"1/2","setting":"A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors","sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","started":"2026-03-31","startedType":"actual","enrolled":118,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07739758","kind":"trial","name":"A Study of YL201 in Combination With Serplulimab in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial testing YL201 in small-cell lung cancer and non-small-cell lung cancer, now recruiting.","summary":"A Study of YL201 in Combination With Serplulimab in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer is a phase 3 interventional study registered as NCT07739758, led by MediLink Therapeutics (Suzhou) with Shanghai Henlius Biotech, and recruiting on the registry. Official title: A Phase III, Multicenter, Randomised, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of YL201 in Combination With Serplulimab Versus Carboplatin and Etoposide in Combination With Serplulimab as First-line Treatment in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer. Planned enrolment is 442 participants (estimated). The study started in 2026-08-18 and primary completion is expected in 2029-06. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07739758","url":"https://clinicaltrials.gov/study/NCT07739758"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","nsclc","extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["yl201"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07739758","phase":"3","setting":"A Phase III, Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of YL201 in Combination With Serplulimab Versus Carboplatin and Etoposide in Combination With Serplulimab as First-line Treatment in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer","sponsor":"MediLink Therapeutics (Suzhou)","started":"2026-08-18","startedType":"actual","enrolled":442,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07258979","kind":"trial","name":"A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.","aka":[],"tldr":"A phase 1/2 trial of YL201, Toripalimab, Cisplatin in nasopharyngeal carcinoma, run by MediLink Therapeutics (Suzhou) Co., Ltd., now recruiting.","summary":"A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma. is a phase 1/2 interventional study registered as NCT07258979 by MediLink Therapeutics (Suzhou) Co., Ltd., with 202 participants planned, started 2025-11-05 and due to reach its primary completion in 2028-02. Interventions recorded: YL201, Toripalimab, Cisplatin. Conditions listed: Recurrent or Metastatic Nasopharyngeal Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07258979","url":"https://clinicaltrials.gov/study/NCT07258979"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nasopharyngeal","locoregionally-advanced-nasopharyngeal-carcinoma","recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["yl201","toripalimab","cisplatin"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07258979","phase":"1/2","setting":"A Multicenter, Open-label, Phase Ib/II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 Combined With Toripalimab, With or Without Cisplatin, in Subjects With Recurrent or Metastatic Nasopharyngeal Carcinoma.","sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","started":"2025-11-05","startedType":"actual","enrolled":202,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05434234","kind":"trial","name":"A Study of YL201 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of YL201 and Atezolizumab in advanced solid tumours, run by MediLink Therapeutics (Suzhou) Co., Ltd., now recruiting.","summary":"A Study of YL201 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05434234 by MediLink Therapeutics (Suzhou) Co., Ltd., with 312 participants planned, started 2022-05-25 and due to reach its primary completion in 2027-04-06. Interventions recorded: YL201 and YL201 and atezolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05434234","url":"https://clinicaltrials.gov/study/NCT05434234"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["yl201","atezolizumab"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05434234","phase":"1/2","setting":"A Phase 1A/1B, Multicenter, Nonrandomized, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL201 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors","sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","started":"2022-05-25","startedType":"actual","enrolled":312,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07169994","kind":"trial","name":"A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of YL202, Toripalimab in non-small-cell lung cancer and small-cell lung cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd., now recruiting.","summary":"A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07169994 by MediLink Therapeutics (Suzhou) Co., Ltd., with 414 participants planned, started 2025-09-02 and due to reach its primary completion in 2026-09-01. Interventions recorded: YL202 for injection; Toripalimab injection, YL202 for injection; Furmonertinib Mesilate Tablets. Conditions listed: Advanced Solid Tumors, Breast Cancer, Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07169994","url":"https://clinicaltrials.gov/study/NCT07169994"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["yl202","toripalimab"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07169994","phase":"1/2","setting":"A Multi-center, Open-Label, Phase Ib/II Study of YL202 in Combination With Anti-tumor Therapy to Evaluate the Safety, Tolerability, and Efficacy in Patients With Advanced Solid Tumors","sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","started":"2025-09-02","startedType":"actual","enrolled":414,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07202364","kind":"trial","name":"A Study of YL202 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 2 trial of YL202 in non-small-cell lung cancer and small-cell lung cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd., now recruiting.","summary":"A Study of YL202 in Patients With Advanced Solid Tumors is a phase 2 interventional study registered as NCT07202364 by MediLink Therapeutics (Suzhou) Co., Ltd., with 100 participants planned, started 2025-08-04 and due to reach its primary completion in 2026-08-31. Interventions recorded: YL202. Conditions listed: Non Small Cell Lung Cancer, Colorectal Cancer, Cervical Cancer, Locally Advanced or Metastatic Solid Tumors. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07202364","url":"https://clinicaltrials.gov/study/NCT07202364"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","colorectal","cervical"],"sections":[],"technologies":[],"targets":[],"drugs":["yl202"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07202364","phase":"2","setting":"A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients With Advanced Solid Tumors","sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","started":"2025-08-04","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06107686","kind":"trial","name":"A Study of YL202 in Selected Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 2 trial of YL202 should be intravenously infused in non-small-cell lung cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd., now recruiting.","summary":"A Study of YL202 in Selected Patients With Advanced Solid Tumors is a phase 2 interventional study registered as NCT06107686 by MediLink Therapeutics (Suzhou) Co., Ltd., with 200 participants planned, started 2023-12-15 and due to reach its primary completion in 2026-11. Interventions recorded: YL202 should be intravenously infused.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06107686","url":"https://clinicaltrials.gov/study/NCT06107686"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["yl202"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06107686","phase":"2","setting":"A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients With Advanced Solid Tumors","sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","started":"2023-12-15","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07197827","kind":"trial","name":"A Study of YL242 in Subjects With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by MediLink Therapeutics (Suzhou) Co., Ltd., now recruiting.","summary":"A Study of YL242 in Subjects With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07197827 by MediLink Therapeutics (Suzhou) Co., Ltd., with 424 participants planned, started 2025-09-22 and due to reach its primary completion in 2028-09. Interventions recorded: YL242, YL242; Pembrolizumab, YL242; 5-FU; LV and YL242; Pembrolizumab; 5-FU.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07197827","url":"https://clinicaltrials.gov/study/NCT07197827"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07197827","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 Monotherapy and Combinations in Advanced Solid Tumors.","sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","started":"2025-09-22","startedType":"actual","enrolled":424,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05100862","kind":"trial","name":"A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphom","aka":["MAHOGANY"],"tldr":"A phase 3 trial of Zanubrutinib, Rituximab, Lenalidomide in follicular lymphoma, run by BeOne Medicines, active and no longer recruiting.","summary":"A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma is a phase 3 interventional study registered as NCT05100862 by BeOne Medicines, with 799 participants enrolled, started 2022-03-10 and due to reach its primary completion in 2028-07. Interventions recorded: Zanubrutinib, Rituximab, Lenalidomide, Obinutuzumab. Conditions listed: Relapsed/Refractory Follicular Lymphoma, Marginal Zone Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05100862","url":"https://clinicaltrials.gov/study/NCT05100862"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["kinase-inhibitors","monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["zanubrutinib","rituximab","lenalidomide","obinutuzumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05100862","phase":"3","setting":"A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma","sponsor":"BeOne Medicines","started":"2022-03-10","startedType":"actual","enrolled":799,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05607108","kind":"trial","name":"A Study of ZEN003694 in People With Squamous Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of ZEN-3694 in lung cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"A Study of ZEN003694 in People With Squamous Cell Lung Cancer is a phase 2, interventional study registered as NCT05607108 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 13 participants, started 2022-11-01 and due to reach its primary completion in 2027-11. Interventions recorded: ZEN003694. Conditions listed: Squamous Cell Lung Cancer. Primary outcome: overall response rate (ORR). Lung eligibility wording from the registry: \"* Histologically-confirmed squamous cell lung cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05607108","url":"https://clinicaltrials.gov/study/NCT05607108"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["zen-3694"],"companies":["zenith-epigenetics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05607108","phase":"2","setting":"Phase 2 Trial of ZEN003694 in Squamous Cell Lung Cancer Patients Harboring NSD3 Amplification","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2022-11-01","startedType":"actual","enrolled":13,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02912949","kind":"trial","name":"A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)","aka":["eNRGy"],"tldr":"A phase 2 trial of Zenocutuzumab in non-small-cell lung cancer and pancreatic ductal adenocarcinoma, run by Partner Therapeutics, Inc., active and no longer recruiting.","summary":"A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy) is a phase 2 interventional study registered as NCT02912949 by Partner Therapeutics, Inc., with 250 participants enrolled, started 2015-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: zenocutuzumab (MCLA-128).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02912949","url":"https://clinicaltrials.gov/study/NCT02912949"},{"label":"Schram et al., efficacy of zenocutuzumab in NRG1 fusion-positive cancer (NEJM 2025)","url":"https://doi.org/10.1056/NEJMoa2405008"},{"label":"Bizengri label (openFDA): pancreatic adenocarcinoma study section","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22BIZENGRI%22"},{"label":"eNRGy (New England Journal of Medicine 2025)","url":"https://doi.org/10.1056/NEJMoa2405008"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","pancreatic","kras-wild-type-pdac","metastatic-pdac"],"sections":[],"technologies":["bispecific-antibody"],"targets":["nrg1","her3"],"drugs":["zenocutuzumab"],"companies":["partner-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-enrgy-zenocutuzumab-nrg1-fusion-positive-cancer-nejm-2025"],"journals":[],"dependsOn":[],"notes":["Registrational phase 2 (NEJM 2025): 204 patients with 12 tumour types treated; among 158 evaluable, response 30 percent (median duration 11.1 months, 19 percent ongoing), including 29 percent in lung and 42 percent in pancreatic cancer; median progression-free survival 6.8 months; treatment-related diarrhoea 18 percent, fatigue 12 percent, nausea 11 percent, infusion reactions 14 percent, one discontinuation. FDA accelerated approval for NRG1 fusion-positive pancreatic adenocarcinoma and lung cancer 4 December 2024 (label cohort of 30 pancreatic patients); cholangiocarcinoma added 2026. One UK site (Sarah Cannon Research Institute, London).","NRG1 fusions bind HER3 and drive heterodimerisation with HER2. In this registrational phase 2 study, 204 patients with advanced NRG1 fusion-positive cancer of any type received zenocutuzumab 750 mg intravenously every two weeks. Among 158 with measurable disease enrolled at least 24 weeks before the cutoff, response occurred in 30 percent (95 percent confidence interval 23 to 37), including 27 of 93 with non-small-cell lung cancer (29 percent, 20 to 39) and 15 of 36 with pancreatic cancer (42 percent, 25 to 59), across multiple fusion partners. Adverse events were mostly grade 1 or 2: diarrhoea 18 percent, fatigue 12 percent, nausea 11 percent, infusion-related reactions 14 percent, with one discontinuation (New England Journal of Medicine 2025). The FDA granted accelerated approval on 4 December 2024. There is no NICE appraisal."],"nct":"NCT02912949","phase":"2","setting":"A Phase I/II Study of MCLA-128, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients With Solid Tumors (eNRGy)","sponsor":"Partner Therapeutics, Inc.","result":"Objective response 30 percent across 158 evaluable NRG1 fusion-positive cancers, 42 percent (15 of 36) in pancreatic cancer; median duration of response 11.1 months; median progression-free survival 6.8 months.","started":"2015-01","startedType":"actual","yearReported":2025,"enrolled":250,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response, pancreatic cancer","unit":"%","arms":[{"name":"Zenocutuzumab 750 mg every 2 weeks","n":36,"value":42,"note":"15 of 36; 95% CI 25 to 59"}],"source":"https://doi.org/10.1056/NEJMoa2405008"},{"endpoint":"Objective response, all evaluable tumour types","primary":true,"unit":"%","arms":[{"name":"Zenocutuzumab 750 mg every 2 weeks","n":158,"value":30,"note":"95% CI 23 to 37"}],"source":"https://doi.org/10.1056/NEJMoa2405008"}]},{"id":"nct05118789","kind":"trial","name":"A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)","aka":["ARROS-1"],"tldr":"A phase 1/2 trial of Zidesamtinib in advanced solid tumours, run by Nuvalent Inc., now recruiting.","summary":"A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) is a phase 1/2 interventional study registered as NCT05118789 by Nuvalent Inc., with 359 participants planned, started 2022-01-04 and due to reach its primary completion in 2027-12-31. Interventions recorded: Zidesamtinib (NVL-520).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05118789","url":"https://clinicaltrials.gov/study/NCT05118789"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["zidesamtinib"],"companies":["nuvalent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05118789","phase":"1/2","setting":"A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors (ARROS-1)","sponsor":"Nuvalent Inc.","started":"2022-01-04","startedType":"actual","enrolled":359,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05458297","kind":"trial","name":"A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-","aka":[],"tldr":"A phase 2 trial of Zilovertamab vedotin, Nemtabrutinib in mantle cell lymphoma and follicular lymphoma, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006) is a phase 2 interventional study registered as NCT05458297 by Merck Sharp & Dohme LLC, with 189 participants planned, started 2022-07-21 and due to reach its primary completion in 2029-05-17. Interventions recorded: Zilovertamab vedotin, Nemtabrutinib. Conditions listed: Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Follicular Lymphoma, Richter Transformation Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05458297","url":"https://clinicaltrials.gov/study/NCT05458297"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma","follicular-lymphoma"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["zilovertamab-vedotin","nemtabrutinib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05458297","phase":"2","setting":"A Multicenter, Open-label, Phase 2 Basket Study to Evaluate the Safety and Efficacy of MK-2140 as a Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (waveLINE-006)","sponsor":"Merck Sharp & Dohme LLC","started":"2022-07-21","startedType":"actual","enrolled":189,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05406401","kind":"trial","name":"A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)","aka":["waveLINE-007"],"tldr":"A phase 2 trial of Zilovertamab vedotin, Cyclophosphamide, Doxorubicin, Rituximab and Prednisone in diffuse large B-cell lymphoma, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007) is a phase 2 interventional study registered as NCT05406401 by Merck Sharp & Dohme LLC, with 60 participants enrolled, started 2022-07-14 and due to reach its primary completion in 2029-04-26. Interventions recorded: Zilovertamab Vedotin, Cyclophosphamide, Doxorubicin, Rituximab, Rituximab Biosimilar and Prednisone.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05406401","url":"https://clinicaltrials.gov/study/NCT05406401"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["zilovertamab-vedotin","cyclophosphamide","doxorubicin","rituximab","prednisone"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05406401","phase":"2","setting":"A Multicenter, Open-label, Phase 2 Dose Escalation and Confirmation, and Efficacy Expansion Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP in Participants With DLBCL (waveLINE)","sponsor":"Merck Sharp & Dohme LLC","started":"2022-07-14","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05967689","kind":"trial","name":"A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.","aka":["REZILIENT2"],"tldr":"A phase 2 trial of TAS6417 in non-small-cell lung cancer, run by Taiho Oncology, Inc., now recruiting.","summary":"A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation. is a phase 2 interventional study registered as NCT05967689 by Taiho Oncology, Inc., with 220 participants planned, started 2023-07-31 and due to reach its primary completion in 2028-08-31. Interventions recorded: TAS6417, CYP Cocktail and Transporter Cocktail.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05967689","url":"https://clinicaltrials.gov/study/NCT05967689"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["araris"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05967689","phase":"2","setting":"An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations.","sponsor":"Taiho Oncology, Inc.","started":"2023-07-31","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07796100","kind":"trial","name":"A Study of ZL-1310 in Combination With a Checkpoint Inhibitor Versus Standard of Care Platinum Based Chemotherapy With a Checkpoint Inhibitor as First-line Ther","aka":[],"tldr":"A phase 3 trial of carboplatin and lurbinectedin in lung cancer, run by Zai Lab (Shanghai) Co., Ltd., not yet recruiting.","summary":"A Study of ZL-1310 in Combination With a Checkpoint Inhibitor Versus Standard of Care Platinum Based Chemotherapy With a Checkpoint Inhibitor as First-line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT07796100 by Zai Lab (Shanghai) Co., Ltd., with a registry enrolment figure of 530 participants, started 2026-12-31 and due to reach its primary completion in 2030-06-30. Interventions recorded: ZL-1310 in combination with Atezolizumab or Durvalumab; Carboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin; Carboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenance. Conditions listed: Extensive-Stage Small Cell Lung Cancer. Primary outcome: Overall survival of ZL-1310 with IO compared to chemo with IO. Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed ES-SCLC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07796100","url":"https://clinicaltrials.gov/study/NCT07796100"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","lurbinectedin"],"companies":["zai-lab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07796100","phase":"3","setting":"A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-drug Conjugate (ADC) in Combination With a Checkpoint Inhibitor Compared to Standard of Care Platinum Based Chemotherapy With a Checkpoint Inhibitor as First-line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer","sponsor":"Zai Lab (Shanghai) Co., Ltd.","started":"2026-12-31","startedType":"estimated","enrolled":530,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06885281","kind":"trial","name":"A Study of ZL-1310 in Participants With Selected Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ZL-1310 in advanced solid tumours, run by Zai Lab (Shanghai) Co., Ltd., now recruiting.","summary":"A Study of ZL-1310 in Participants With Selected Solid Tumors is a phase 1/2 interventional study registered as NCT06885281 by Zai Lab (Shanghai) Co., Ltd., with 166 participants planned, started 2025-05-12 and due to reach its primary completion in 2027-08. Interventions recorded: ZL-1310.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06885281","url":"https://clinicaltrials.gov/study/NCT06885281"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["zl-1310"],"companies":["zai-lab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06885281","phase":"1/2","setting":"A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors","sponsor":"Zai Lab (Shanghai) Co., Ltd.","started":"2025-05-12","startedType":"actual","enrolled":166,"enrolledBasis":"registry","outcomes":[]},{"id":"dllevate","kind":"trial","name":"A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)","aka":["DLLEVATE"],"tldr":"A phase 3 trial testing ZL-1310 in non-small-cell lung cancer, now recruiting.","summary":"A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE) is a phase 3 interventional study registered as NCT07218146, led by Zai Lab (Shanghai) with Zai Lab (US), and recruiting on the registry. Official title: A Randomised, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator's Choice Therapy in Participants With Relapsed Small Cell Lung Cancer. Planned enrolment is 480 participants (estimated). The study started in 2025-11-30 and primary completion is expected in 2028-06-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07218146","url":"https://clinicaltrials.gov/study/NCT07218146"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["zl-1310"],"companies":["zai-lab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07218146","phase":"3","setting":"A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator's Choice Therapy in Participants With Relapsed Small Cell Lung Cancer","sponsor":"Zai Lab (Shanghai)","started":"2025-11-30","startedType":"actual","enrolled":480,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03505320","kind":"trial","name":"A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer","aka":["ILUSTRO"],"tldr":"A phase 2 trial of Zolbetuximab, Oxaliplatin, Pembrolizumab, Leucovorin (folinic acid), Nivolumab and Docetaxel in gastric & gastro-oesophageal junction cancer, run by Astellas Pharma Global Development, Inc., active and no longer recruiting.","summary":"A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer is a phase 2 interventional study registered as NCT03505320 by Astellas Pharma Global Development, Inc., with 143 participants enrolled, started 2018-06-29 and due to reach its primary completion in 2027-06-30. Interventions recorded: zolbetuximab, oxaliplatin, leucovorin, fluorouracil, Pembrolizumab and folinic acid.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03505320","url":"https://clinicaltrials.gov/study/NCT03505320"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["zolbetuximab","oxaliplatin","pembrolizumab","leucovorin","nivolumab","docetaxel"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03505320","phase":"2","setting":"A Phase 2 Study of Zolbetuximab (IMAB362) as Monotherapy and in Combination With Chemotherapy and/or Immunotherapy in Subjects With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and Locoregional Gastric or GEJ Adenocarcinoma Whose Are Claudin (CLDN) 18.2 Positive","sponsor":"Astellas Pharma Global Development, Inc.","started":"2018-06-29","startedType":"actual","enrolled":143,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03816163","kind":"trial","name":"A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of Zolbetuximab and Gemcitabine in pancreatic ductal adenocarcinoma, run by Astellas Pharma Global Development, Inc., active and no longer recruiting.","summary":"A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer is a phase 2 interventional study registered as NCT03816163 by Astellas Pharma Global Development, Inc., with 393 participants enrolled, started 2019-03-15 and due to reach its primary completion in 2026-08-31. Interventions recorded: zolbetuximab, nab-paclitaxel and gemcitabine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03816163","url":"https://clinicaltrials.gov/study/NCT03816163"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["zolbetuximab","gemcitabine"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03816163","phase":"2","setting":"A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma","sponsor":"Astellas Pharma Global Development, Inc.","started":"2019-03-15","startedType":"actual","enrolled":393,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06901531","kind":"trial","name":"A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer","aka":["LUCERNA"],"tldr":"A phase 3 trial of Zolbetuximab, Pembrolizumab, Capecitabine, Oxaliplatin, Leucovorin (folinic acid) and Fluorouracil (5-FU) in gastric & gastro-oesophageal junction cancer, run by Astellas Pharma Global Development, Inc., now recruiting.","summary":"A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer is a phase 3 interventional study registered as NCT06901531 by Astellas Pharma Global Development, Inc., with 500 participants planned, started 2025-05-22 and due to reach its primary completion in 2028-09-30. Interventions recorded: zolbetuximab, Pembrolizumab, Capecitabine, Oxaliplatin, Folinic acid (leucovorin or local equivalent) and 5-fluorouracil (5-FU).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06901531","url":"https://clinicaltrials.gov/study/NCT06901531"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","gastric-pdl1-high"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["zolbetuximab","pembrolizumab","capecitabine","oxaliplatin","leucovorin","fluorouracil"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06901531","phase":"3","setting":"A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive","sponsor":"Astellas Pharma Global Development, Inc.","started":"2025-05-22","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06944106","kind":"trial","name":"A Study on Ivonescimab Plus Chemotherapy as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of ivonescimab in pancreatic cancer, run by Tianjin Medical University Cancer Institute and Hospital, now recruiting.","summary":"A Study on Ivonescimab Plus Chemotherapy as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer is a phase 2, interventional study registered as NCT06944106 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 30 participants, started 2025-03-28 and due to reach its primary completion in 2026-04-28. Interventions recorded: AK112. Conditions listed: Pancreatic Cancer. Primary outcome: R0 and R1 resection rates. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed pancreatic cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06944106","url":"https://clinicaltrials.gov/study/NCT06944106"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06944106","phase":"2","setting":"A Prospective, Single-arm, Phase II Clinical Study on the Efficacy and Safety of Ivonescimab Combined With Gemcitabine and Nab-paclitaxel (AG) Regimen as Neoadjuvant Treatment for Borderline Resectable Pancreatic Cancer","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2025-03-28","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07123441","kind":"trial","name":"A Study on the Efficacy and Safety of Irinotecan Liposome (II), 5-FU/LV in Combination With Bevacizumab for the Treatment of Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of leucovorin (folinic acid) in colorectal cancer, run by Sanjun Cai, not yet recruiting.","summary":"A Study on the Efficacy and Safety of Irinotecan Liposome (II), 5-FU/LV in Combination With Bevacizumab for the Treatment of Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT07123441 by Sanjun Cai, with a registry enrolment figure of 300 participants, started 2025-09-01 and due to reach its primary completion in 2027-09-01. Interventions recorded: Bevacizumab,Irinotecan liposome (II),5-FU/LV. Conditions listed: Colorectal Cancer. Primary outcome: Safety:The incidence of adverse events. Colorectal eligibility wording from the registry: \"Patients with pathologically confirmed, unresectable advanced colorectal cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07123441","url":"https://clinicaltrials.gov/study/NCT07123441"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07123441","phase":"2","setting":"A Study on the Efficacy and Safety of Irinotecan Liposome (II), 5-FU/LV in Combination With Bevacizumab for the Treatment of Advanced Colorectal Cancer","sponsor":"Sanjun Cai","started":"2025-09-01","startedType":"estimated","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06590259","kind":"trial","name":"A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Shanghai 6th People's Hospital, now recruiting.","summary":"A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM is a phase 2, interventional study registered as NCT06590259 by Shanghai 6th People's Hospital, with a registry enrolment figure of 20 participants, started 2024-03-12 and due to reach its primary completion in 2027-07. Interventions recorded: Multi-mode tumor treatment system; Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab. Conditions listed: Colorectal Cancer Liver Metastasis. Primary outcome: Progression Free Survival (PFS). Colorectal eligibility wording from the registry: \"Pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06590259","url":"https://clinicaltrials.gov/study/NCT06590259"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["thermal-ablation"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06590259","phase":"2","setting":"A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy Including PD-1 Inhibitor in the Treatment of Colorectal Cancer Liver Metastasis(CRCLM)","sponsor":"Shanghai 6th People's Hospital","started":"2024-03-12","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01517802","kind":"trial","name":"A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate","aka":[],"tldr":"A phase 3 trial of Abiraterone acetate and Prednisone in Prostate cancer, run by Janssen Research & Development, LLC, completed.","summary":"A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate is a phase 3 interventional study registered as NCT01517802 by Janssen Research & Development, LLC, with 32 participants recorded, started 2012-03-28 and reaching its primary completion in 2021-04-22. Interventions recorded: Abiraterone acetate, Prednisone. Conditions recorded: Metastatic Castration-resistant Prostate Cancer, Metastatic Breast Cancer.\n\nLinked to the idea \"Prescribe a quarter dose of abiraterone with breakfast\" because the registry names Abiraterone acetate and Prednisone among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01517802","url":"https://clinicaltrials.gov/study/NCT01517802"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["abiraterone","prednisone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01517802","phase":"3","setting":"A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study","sponsor":"Janssen Research & Development, LLC","started":"2012-03-28","startedType":"actual","yearReported":2022,"enrolled":32,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Serious Adverse Events (SAEs)","primary":true,"unit":"participants","arms":[{"name":"Abiraterone Acetate + Prednisone/Prednisolone","n":31,"value":16,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-05-10), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01517802?tab=results"}]},{"id":"nct05485948","kind":"trial","name":"A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU","aka":[],"tldr":"A phase 2 trial of Ropeginterferon alfa-2b in myeloproliferative neoplasms, run by PharmaEssentia, active and no longer recruiting.","summary":"A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU is a phase 2 interventional study registered as NCT05485948 by PharmaEssentia, with 49 participants enrolled, started 2021-10-08 and due to reach its primary completion in 2022-09-07. Interventions recorded: Ropeginterferon alfa-2b.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05485948","url":"https://clinicaltrials.gov/study/NCT05485948"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","polycythaemia-vera"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["ropeginterferon-alfa-2b"],"companies":["pharmaessentia"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05485948","phase":"2","setting":"A Phase II Single-Arm Multicenter Study to Access Efficacy and Safety of P1101 in Chinese Polycythemia Vera Patients Who Are Intolerant or Resistance to Hydroxyurea","sponsor":"PharmaEssentia","started":"2021-10-08","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07525206","kind":"trial","name":"A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer","aka":["AndroMETa-CRC"],"tldr":"A phase 3 trial testing Telisotuzumab adizutecan in colorectal cancer, now recruiting.","summary":"A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer is a phase 3 interventional study registered as NCT07525206, led by AbbVie, and recruiting on the registry. Official title: An Open-Label, Randomised, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer. Planned enrolment is 700 participants (estimated). The study started in 2026-05-22 and primary completion is expected in 2029-05. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07525206","url":"https://clinicaltrials.gov/study/NCT07525206"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["telisotuzumab-adizutecan"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07525206","phase":"3","setting":"An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer","sponsor":"AbbVie","started":"2026-05-22","startedType":"actual","enrolled":700,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03744715","kind":"trial","name":"A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib","aka":[],"tldr":"A phase 2 trial of Poziotinib in Breast cancer, run by Spectrum Pharmaceuticals, Inc, recorded as terminated on the registry.","summary":"A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib is a phase 2 interventional study registered as NCT03744715 by Spectrum Pharmaceuticals, Inc, with 7 participants recorded, started 2018-10-11 and due to reach its primary completion in 2023-03-03. Interventions recorded: Poziotinib. Conditions recorded: NSCLC, Breast Cancer.\n\nLinked to the drug Poziotinib because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03744715","url":"https://clinicaltrials.gov/study/NCT03744715"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["poziotinib"],"companies":["spectrum-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03744715","phase":"2","setting":"An Open-Label Extension Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib","sponsor":"Spectrum Pharmaceuticals, Inc","started":"2018-10-11","startedType":"actual","yearReported":2026,"enrolled":7,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Adverse Events (AEs)","primary":true,"unit":"participants","arms":[{"name":"Poziotinib 6 mg","n":1,"value":1,"note":"Figures from the ClinicalTrials.gov results section (first posted 2026-07-28), not from a publication"},{"name":"Poziotinib 8 mg","n":1,"value":1},{"name":"Poziotinib 12 mg","n":1,"value":1},{"name":"Poziotinib 14 mg","n":1,"value":1},{"name":"Poziotinib 16 mg","n":2,"value":2},{"name":"Poziotinib 24 mg","n":1,"value":1}],"source":"https://clinicaltrials.gov/study/NCT03744715?tab=results"}]},{"id":"nct07095452","kind":"trial","name":"A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lena","aka":[],"tldr":"A phase 2/3 trial of Lenalidomide, Daratumumab, Dexamethasone in multiple myeloma, run by AbbVie, now recruiting.","summary":"A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant is a phase 2/3 interventional study registered as NCT07095452 by AbbVie, with 660 participants planned, started 2026-01-08 and due to reach its primary completion in 2042-01. Interventions recorded: Etentamig, Lenalidomide, Daratumumab, Dexamethasone, Dexamethasone. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07095452","url":"https://clinicaltrials.gov/study/NCT07095452"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-transplant-ineligible"],"sections":[],"technologies":["antiemetic-therapy","monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["lenalidomide","daratumumab","dexamethasone"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07095452","phase":"2/3","setting":"Phase 2/3, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Subjects With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant","sponsor":"AbbVie","started":"2026-01-08","startedType":"actual","enrolled":660,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06833008","kind":"trial","name":"A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours","aka":[],"tldr":"A phase 1/2 trial of IPN01195 in advanced solid tumours, run by Ipsen, now recruiting.","summary":"A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours is a phase 1/2 interventional study registered as NCT06833008 by Ipsen, with 85 participants planned, started 2025-03-14 and due to reach its primary completion in 2028-10-03. Interventions recorded: IPN01195.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06833008","url":"https://clinicaltrials.gov/study/NCT06833008"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06833008","phase":"1/2","setting":"An Open-label, Phase I/II First-in-human, Dose Escalation and Confirmation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Anti-tumour Activity of IPN01195 as Single Agent in Adult Participants With Advanced Solid Tumours","sponsor":"Ipsen","started":"2025-03-14","startedType":"actual","enrolled":85,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07023289","kind":"trial","name":"A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone o","aka":[],"tldr":"A phase 2 trial of Telisotuzumab adizutecan in colorectal cancer, run by AbbVie, now recruiting.","summary":"A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease is a phase 2 interventional study registered as NCT07023289 by AbbVie, with 140 participants planned, started 2025-09-02 and due to reach its primary completion in 2029-11. Interventions recorded: Telisotuzumab Adizutecan, Standard of Care. Conditions listed: Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07023289","url":"https://clinicaltrials.gov/study/NCT07023289"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["telisotuzumab-adizutecan"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07023289","phase":"2","setting":"A Phase 2, Randomized, Open-Label Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to the Current Standard of Care in Subjects With Post Adjuvant ctDNA Positive Colorectal Cancer and No Radiographic Evidence of Disease (NED)","sponsor":"AbbVie","started":"2025-09-02","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07196644","kind":"trial","name":"A Study to Assess Adverse Events and Change in Disease Activity in Participants 12 Years of Age or Older With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification Receiving Intravenously Infused Telisotuzumab Adizutecan","aka":[],"tldr":"A phase 2 trial of Telisotuzumab adizutecan in advanced solid tumours, run by AbbVie, now recruiting.","summary":"A Study to Assess Adverse Events and Change in Disease Activity in Participants 12 Years of Age or Older With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification Receiving Intravenously Infused Telisotuzumab Adizutecan is a phase 2 interventional study registered as NCT07196644 by AbbVie, with 100 participants planned, started 2025-12-01 and due to reach its primary completion in 2030-12. Interventions recorded: Telisotuzumab Adizutecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07196644","url":"https://clinicaltrials.gov/study/NCT07196644"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["telisotuzumab-adizutecan"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07196644","phase":"2","setting":"A Phase 2 Study to Evaluate the Safety and Efficacy of Telisotuzumab Adizutecan for the Treatment of Subjects With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification","sponsor":"AbbVie","started":"2025-12-01","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06682988","kind":"trial","name":"A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primar","aka":[],"tldr":"A phase 2 trial of Mirvetuximab soravtansine in ovarian cancer, run by AbbVie, now recruiting.","summary":"A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine is a phase 2 interventional study registered as NCT06682988 by AbbVie, with 110 participants planned, started 2025-05-28 and due to reach its primary completion in 2026-07. Interventions recorded: Mirvetuximab Soravtansine. Conditions listed: Advanced High-Grade Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancers. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06682988","url":"https://clinicaltrials.gov/study/NCT06682988"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["mirvetuximab-soravtansine"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06682988","phase":"2","setting":"A Randomized Phase 2, Open-label Study of Mirvetuximab Soravtansine in Patients With Platinum-resistant Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-alpha Expression Testing 2 Schedules of Administration for Dose Optimization, With a Separate Cohort to Determine Starting Dose in Patients With Moderate Hepatic Impairment","sponsor":"AbbVie","started":"2025-05-28","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07155187","kind":"trial","name":"A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2/3 trial testing Telisotuzumab adizutecan in non-small-cell lung cancer, now recruiting.","summary":"A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer is a phase 2/3 interventional study registered as NCT07155187, led by AbbVie, and recruiting on the registry. Official title: A Phase 2/3 Open Label Randomised Study of Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713. Planned enrolment is 490 participants (estimated). The study started in 2025-12-10 and primary completion is expected in 2030-09. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07155187","url":"https://clinicaltrials.gov/study/NCT07155187"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["telisotuzumab-adizutecan"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07155187","phase":"2/3","setting":"A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713","sponsor":"AbbVie","started":"2025-12-10","startedType":"actual","enrolled":490,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07059845","kind":"trial","name":"A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult","aka":["FLORENZA"],"tldr":"A phase 2 trial of Mirvetuximab soravtansine, Bevacizumab, Carboplatin in ovarian cancer, run by AbbVie, now recruiting.","summary":"A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer is a phase 2 interventional study registered as NCT07059845 by AbbVie, with 400 participants planned, started 2025-11-13 and due to reach its primary completion in 2029-01. Interventions recorded: Mirvetuximab Soravtansine, Bevacizumab, Carboplatin. Conditions listed: Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07059845","url":"https://clinicaltrials.gov/study/NCT07059845"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["mirvetuximab-soravtansine","bevacizumab","carboplatin"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07059845","phase":"2","setting":"A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Mirvetuximab Soravtansine in Subjects With Ovarian Cancer","sponsor":"AbbVie","started":"2025-11-13","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06953960","kind":"trial","name":"A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and/or Oral Antimyeloma ","aka":[],"tldr":"A phase 1/2 trial of Daratumumab, Dexamethasone, Pomalidomide in multiple myeloma, run by AbbVie, now recruiting.","summary":"A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM) is a phase 1/2 interventional study registered as NCT06953960 by AbbVie, with 325 participants planned, started 2025-07-23 and due to reach its primary completion in 2030-12. Interventions recorded: Surzetoclax, Daratumumab, Dexamethasone, Pomalidomide, Etentamig. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06953960","url":"https://clinicaltrials.gov/study/NCT06953960"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["daratumumab","dexamethasone","pomalidomide"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06953960","phase":"1/2","setting":"A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) Given as Monotherapy or in Combination With Antimyeloma Regimens in Subjects With Multiple Myeloma","sponsor":"AbbVie","started":"2025-07-23","startedType":"actual","enrolled":325,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07581002","kind":"trial","name":"A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML)","aka":["REVIVAL"],"tldr":"A phase 2/3 trial of Pivekimab sunirine, Venetoclax and Azacitidine in acute myeloid leukaemia, run by AbbVie, now recruiting.","summary":"A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) is a phase 2/3 interventional study registered as NCT07581002 by AbbVie, with 660 participants planned, started 2026-06-30 and due to reach its primary completion in 2032-06. Interventions recorded: Pivekimab Sunirine, Venetoclax, Azacitidine and Matching Placebo for PVEK.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07581002","url":"https://clinicaltrials.gov/study/NCT07581002"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["adc","bcl2-inhibitors","cytotoxic-chemotherapy","epigenetic-drugs","kinase-inhibitors"],"targets":[],"drugs":["pivekimab-sunirine","venetoclax","azacitidine"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07581002","phase":"2/3","setting":"A Randomized Phase 2/3 Study Evaluating the Safety and Efficacy of Pivekimab Sunirine (PVEK) in Combination With Venetoclax and Azacitidine in Adult Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible to Receive Intensive Chemotherapy","sponsor":"AbbVie","started":"2026-06-30","startedType":"actual","enrolled":660,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07769502","kind":"trial","name":"A Study to Assess Adverse Events and Change in Disease Activity With Treatment Combinations With Telisotuzumab Adizutecan in Adults Participants With Pancreatob","aka":["AndroMETa-118"],"tldr":"A phase 2 trial of telisotuzumab adizutecan, gemcitabine and nab-paclitaxel in pancreatic cancer, run by AbbVie, now recruiting.","summary":"A Study to Assess Adverse Events and Change in Disease Activity With Treatment Combinations With Telisotuzumab Adizutecan in Adults Participants With Pancreatobiliary Cancers is a phase 2, randomised interventional study registered as NCT07769502 by AbbVie, with a registry enrolment figure of 168 participants, started 2026-08-17 and due to reach its primary completion in 2028-09. Interventions recorded: Telisotuzumab Adizutecan; Gemcitabine; Nab-Paclitaxel. Conditions listed: Pancreatobiliary Cancers; Pancreatic Ductal Adenocarcinoma. Primary outcome: Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; Number of Participants with Adverse Events (AEs). Sites: Israel, Japan, Taiwan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07769502","url":"https://clinicaltrials.gov/study/NCT07769502"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["telisotuzumab-adizutecan","gemcitabine","nab-paclitaxel"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07769502","phase":"2","setting":"A Phase 2, Open-Label, Master Protocol Study to Evaluate Safety and Efficacy of Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Pancreatobiliary Cancers (AndroMETa-118)","sponsor":"AbbVie","started":"2026-08-17","startedType":"actual","enrolled":168,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06568939","kind":"trial","name":"A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult ","aka":[],"tldr":"A phase 2 trial of Telisotuzumab vedotin in non-small-cell lung cancer and small-cell lung cancer, run by AbbVie, now recruiting.","summary":"A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC) is a phase 2 interventional study registered as NCT06568939 by AbbVie, with 150 participants planned, started 2025-01-20 and due to reach its primary completion in 2028-02. Interventions recorded: Telisotuzumab Vedotin. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06568939","url":"https://clinicaltrials.gov/study/NCT06568939"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","met-altered-nsclc"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["telisotuzumab-vedotin"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06568939","phase":"2","setting":"A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer","sponsor":"AbbVie","started":"2025-01-20","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07005102","kind":"trial","name":"A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2/3 trial testing Telisotuzumab adizutecan in non-small-cell lung cancer, now recruiting.","summary":"A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer is a phase 2/3 interventional study registered as NCT07005102, led by AbbVie, and recruiting on the registry. Official title: A Phase 2/3 Randomised Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer. Planned enrolment is 854 participants (estimated). The study started in 2025-08-03 and primary completion is expected in 2031-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07005102","url":"https://clinicaltrials.gov/study/NCT07005102"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["telisotuzumab-adizutecan"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07005102","phase":"2/3","setting":"A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer","sponsor":"AbbVie","started":"2025-08-03","startedType":"actual","enrolled":854,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06890338","kind":"trial","name":"A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Fo","aka":[],"tldr":"A phase 2 trial of Carboplatin, Mirvetuximab soravtansine, Bevacizumab in ovarian cancer, run by AbbVie, now recruiting.","summary":"A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer. is a phase 2 interventional study registered as NCT06890338 by AbbVie, with 140 participants planned, started 2025-11-21 and due to reach its primary completion in 2030-02. Interventions recorded: Carboplatin, Mirvetuximab Soravtansine, Bevacizumab. Conditions listed: Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Neoadjuvant. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06890338","url":"https://clinicaltrials.gov/study/NCT06890338"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","mirvetuximab-soravtansine","bevacizumab"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06890338","phase":"2","setting":"A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects With FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","sponsor":"AbbVie","started":"2025-11-21","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06090539","kind":"trial","name":"A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas","aka":[],"tldr":"A phase 1/2 trial of Rituximab, Glofitamab, Obinutuzumab in hodgkin lymphoma and non-hodgkin lymphoma, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas is a phase 1/2 interventional study registered as NCT06090539 by Bristol-Myers Squibb, with 460 participants planned, started 2023-12-29 and due to reach its primary completion in 2027-10-28. Interventions recorded: BMS-986458, Rituximab, Glofitamab/Obinutuzumab, Mosunetuzumab, Epcoritamab. Conditions listed: Relapsed/Refractory Non-Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06090539","url":"https://clinicaltrials.gov/study/NCT06090539"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["rituximab","glofitamab","obinutuzumab","mosunetuzumab","epcoritamab","golcadomide"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06090539","phase":"1/2","setting":"A Phase 1/2, Multi-Center, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BMS-986458, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed/Refractory Non-Hodgkin Lymphomas (R/R NHL)","sponsor":"Bristol-Myers Squibb","started":"2023-12-29","startedType":"actual","enrolled":460,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06892522","kind":"trial","name":"A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving T Cell Engaging Bi/Tri-spe","aka":[],"tldr":"A phase 1/2 trial of Lenalidomide, Dexamethasone, Daratumumab in multiple myeloma, run by AbbVie, now recruiting.","summary":"A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving T Cell Engaging Bi/Tri-specific Antibodies Intravenously (IV)/Subcutaneously (SC) Alone or in Combinations is a phase 1/2 interventional study registered as NCT06892522 by AbbVie, with 602 participants planned, started 2025-06-30 and due to reach its primary completion in 2035-12. Interventions recorded: Etentamig, Lenalidomide, Dexamethasone, Daratumumab, Dexamethasone. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06892522","url":"https://clinicaltrials.gov/study/NCT06892522"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["lenalidomide","dexamethasone","daratumumab","carfilzomib","mezigdomide","iberdomide"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06892522","phase":"1/2","setting":"A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of T Cell Engaging Bi/Tri-specific Antibodies in Subjects With MM","sponsor":"AbbVie","started":"2025-06-30","startedType":"actual","enrolled":602,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07024784","kind":"trial","name":"A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN1","aka":[],"tldr":"A phase 2 trial of Carboplatin, Bevacizumab, Olaparib in ovarian cancer, run by AbbVie, now recruiting.","summary":"A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN151 as Monotherapy or in Combination With Other Therapies is a phase 2 interventional study registered as NCT07024784 by AbbVie, with 377 participants planned, started 2025-07-30 and due to reach its primary completion in 2028-01. Interventions recorded: IMGN151, Carboplatin, Bevacizumab, Olaparib. Conditions listed: Gynecologic Cancers, Platinum-Sensitive Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer (PSOC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07024784","url":"https://clinicaltrials.gov/study/NCT07024784"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["carboplatin","bevacizumab","olaparib"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07024784","phase":"2","setting":"A Phase 1b Dose Escalation and Expansion Study of IMGN151 as Monotherapy and in Combination With Other Anti-Cancer Therapies in Subjects With Gynecologic Cancers","sponsor":"AbbVie","started":"2025-07-30","startedType":"actual","enrolled":377,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06312137","kind":"trial","name":"A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Sm","aka":["TroFuse-019"],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Pembrolizumab, Cisplatin in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) is a phase 3 interventional study registered as NCT06312137 by Merck Sharp & Dohme LLC, with 780 participants planned, started 2024-04-03 and due to reach its primary completion in 2034-02-21. Interventions recorded: Sacituzumab tirumotecan, Pembrolizumab, Cisplatin, Pemetrexed, Gemcitabine. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06312137","url":"https://clinicaltrials.gov/study/NCT06312137"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","pembrolizumab","cisplatin","pemetrexed","gemcitabine","carboplatin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06312137","phase":"3","setting":"A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery","sponsor":"Merck Sharp & Dohme LLC","started":"2024-04-03","startedType":"actual","enrolled":780,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05481151","kind":"trial","name":"A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV","aka":[],"tldr":"A phase 3 trial of Ropeginterferon alfa-2b in myeloproliferative neoplasms, run by PharmaEssentia, active and no longer recruiting.","summary":"A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV is a phase 3 interventional study registered as NCT05481151 by PharmaEssentia, with 111 participants enrolled, started 2022-10-26 and due to reach its primary completion in 2025-06-30. Interventions recorded: P1101 (Ropeginterferon alfa-2b-njft) and Ropeginterferon alfa-2b-njft (P1101).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05481151","url":"https://clinicaltrials.gov/study/NCT05481151"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","polycythaemia-vera"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["ropeginterferon-alfa-2b"],"companies":["pharmaessentia"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05481151","phase":"3","setting":"A Phase IIIb, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Two Dosing Regimens of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Polycythemia Vera (PV)","sponsor":"PharmaEssentia","started":"2022-10-26","startedType":"actual","enrolled":111,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07821684","kind":"trial","name":"A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants Previously Treated, EGFR Wildtype, Locally Advanc","aka":[],"tldr":"A phase 3 trial of telisotuzumab adizutecan, docetaxel and ramucirumab in lung cancer, run by AbbVie, not yet recruiting.","summary":"A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants Previously Treated, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT07821684 by AbbVie, with a registry enrolment figure of 660 participants, started 2027-01-06 and due to reach its primary completion in 2031-04. Interventions recorded: Telisotuzumab Adizutecan; Docetaxel; Ramucirumab. Conditions listed: Non-Squamous Non-Small Cell Lung Cancer. Primary outcome: Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; Overall Survival (OS). Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed metastatic/locally advanced non-squamous NSCLC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07821684","url":"https://clinicaltrials.gov/study/NCT07821684"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","met-altered-nsclc"],"sections":[],"technologies":["adc","antiangiogenic","cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["telisotuzumab-adizutecan","docetaxel","ramucirumab"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07821684","phase":"3","setting":"A Phase 3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Previously Treated, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer Expressing c-Met Protein Level Above a Defined Cutoff","sponsor":"AbbVie","started":"2027-01-06","startedType":"estimated","enrolled":660,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07756645","kind":"trial","name":"A Study to Assess Intravenous ABBV-1480 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First Line Treatment of Locally Advan","aka":[],"tldr":"A phase 3 trial of pembrolizumab, carboplatin, paclitaxel / nab-paclitaxel and nab-paclitaxel in lung cancer, run by AbbVie, not yet recruiting.","summary":"A Study to Assess Intravenous ABBV-1480 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First Line Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer in Adult Participants is a phase 3, randomised interventional study registered as NCT07756645 by AbbVie, with a registry enrolment figure of 940 participants, started 2026-09-22 and due to reach its primary completion in 2029-12. Interventions recorded: ABBV-1480; Pembrolizumab; Carboplatin; Paclitaxel; Nab- Paclitaxel. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Progression-Free Survival (PFS) assessed by the Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; Overall Survival (OS). Lung eligibility wording from the registry: \"* Adult subjects with a histologically or cytologically confirmed diagnosis of Stage IIIB, IIIC, or IV sqNSCLC that is not amenable to curative treatment\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07756645","url":"https://clinicaltrials.gov/study/NCT07756645"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pembrolizumab","carboplatin","paclitaxel","nab-paclitaxel"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07756645","phase":"3","setting":"A Randomized, Multiregional, Open-Label Phase 3 Clinical Trial of ABBV-1480 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First Line Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer","sponsor":"AbbVie","started":"2026-09-22","startedType":"estimated","enrolled":940,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06305247","kind":"trial","name":"A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours","aka":[],"tldr":"A phase 1/2 trial of IPN01194 in melanoma, head and neck squamous cell carcinoma, pancreatic ductal adenocarcinoma and colorectal cancer, run by Ipsen, active and no longer recruiting.","summary":"A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours is a phase 1/2 interventional study registered as NCT06305247 by Ipsen, with 36 participants enrolled, started 2024-04-03 and due to reach its primary completion in 2028-03-20. Interventions recorded: IPN01194.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06305247","url":"https://clinicaltrials.gov/study/NCT06305247"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","head-and-neck","pancreatic","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06305247","phase":"1/2","setting":"An Open-label, Phase I/IIa First-in-human, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Antitumour Activity of ERK1/2 Inhibitor IPN01194 as Single Agent in Adult Participants With Advanced Solid Tumours","sponsor":"Ipsen","started":"2024-04-03","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"seacraft-2","kind":"trial","name":"A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)","aka":["SEACRAFT-2"],"tldr":"A phase 3 trial testing Naporafenib in melanoma, active and no longer recruiting.","summary":"A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2) is a phase 3 interventional study registered as NCT06346067, led by Erasca, and active but no longer recruiting on the registry. Official title: A Randomised, Open-label Phase III Study in Patients With Previously Treated Unresectable or Metastatic NRAS Mutant Cutaneous Melanoma Comparing the Combination of Naporafenib + Trametinib to Physician's Choice of Therapy (Dacarbazine, Temozolomide or Trametinib Monotherapy) With a Dose Optimization lead-in [SEACRAFT-2]. Planned enrolment is 78 participants (actual). The study started in 2024-04-29 and primary completion is expected in 2028-04. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06346067","url":"https://clinicaltrials.gov/study/NCT06346067"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["naporafenib"],"companies":["erasca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06346067","phase":"3","setting":"A Randomized, Open-label Phase III Study in Patients With Previously Treated Unresectable or Metastatic NRAS Mutant Cutaneous Melanoma Comparing the Combination of Naporafenib + Trametinib to Physician's Choice of Therapy (Dacarbazine, Temozolomide or Trametinib Monotherapy) With a Dose Optimization lead-in [SEACRAFT-2]","sponsor":"Erasca","started":"2024-04-29","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05950165","kind":"trial","name":"A Study to Assess Safety and Efficacy of CHO-H01 as a Single Agent/Combined With Lenalidomide in Subjects With Refractory or Relapsed Non-Hodgkin's Ly","aka":[],"tldr":"A phase 1/2 trial of Lenalidomide in hodgkin lymphoma and non-hodgkin lymphoma, run by Cho Pharma Inc., active and no longer recruiting.","summary":"A Study to Assess Safety and Efficacy of CHO-H01 as a Single Agent/Combined With Lenalidomide in Subjects With Refractory or Relapsed Non-Hodgkin's Lymphoma is a phase 1/2 interventional study registered as NCT05950165 by Cho Pharma Inc., with 37 participants planned, started 2020-01-15 and due to reach its primary completion in 2026-12-23. Interventions recorded: CHO-H01, CHO-H01 at RP2D, Lenalidomide. Conditions listed: Non-Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05950165","url":"https://clinicaltrials.gov/study/NCT05950165"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["protac-degrader"],"targets":[],"drugs":["lenalidomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05950165","phase":"1/2","setting":"A Phase I/IIa, Open-label, Multicenter Study of the Safety and Efficacy of CHO-H01 as a Single Agent/Combined With Lenalidomide to Subjects With Refractory or Relapsed Non-Hodgkin's Lymphoma","sponsor":"Cho Pharma Inc.","started":"2020-01-15","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04452955","kind":"trial","name":"A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors","aka":[],"tldr":"A phase 2 trial of PRL3-zumab in advanced solid tumours, run by Intra-IMMUSG Pte Ltd, active and no longer recruiting.","summary":"A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors is a phase 2 interventional study registered as NCT04452955 by Intra-IMMUSG Pte Ltd, with 51 participants enrolled, started 2020-12-12 and due to reach its primary completion in 2026-12-01. Interventions recorded: PRL3-zumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04452955","url":"https://clinicaltrials.gov/study/NCT04452955"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["intra-immusg","parexel"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04452955","phase":"2","setting":"An Open Label, Multicenter, Safety and Efficacy Phase 2 Study of PRL3-Zumab in Solid Tumors","sponsor":"Intra-IMMUSG Pte Ltd","started":"2020-12-12","startedType":"actual","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07693751","kind":"trial","name":"A Study to Assess Safety and Efficacy of SOT109 in Patients With Advanced Unresectable or Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by SOTIO Biotech a.s., now recruiting.","summary":"A Study to Assess Safety and Efficacy of SOT109 in Patients With Advanced Unresectable or Metastatic Colorectal Cancer is a phase 1/2, randomised interventional study registered as NCT07693751 by SOTIO Biotech a.s., with a registry enrolment figure of 100 participants, started 2026-08-12 and due to reach its primary completion in 2027-11-29. Interventions recorded: SOT109. Conditions listed: Colorectal Cancer (Locally Advanced or Metastatic). Primary outcome: Part A: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT109; Part B: Optimal dose of SOT109 for subsequent clinical trials; Part B: Objective Response Rate (ORR) of SOT109. Colorectal eligibility wording from the registry: \"* Direct (conjugated) bilirubin is within normal limits (≤ULN), and\". Sites: Moldova, United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07693751","url":"https://clinicaltrials.gov/study/NCT07693751"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sotio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07693751","phase":"1/2","setting":"A First-in-human Phase 1/2 Trial to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of SOT109 in Patients With Advanced Unresectable or Metastatic Colorectal Cancer","sponsor":"SOTIO Biotech a.s.","started":"2026-08-12","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05706129","kind":"trial","name":"A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of [68Ga]Ga-DPI-4452 in renal cell carcinoma, pancreatic ductal adenocarcinoma, colorectal cancer, bladder & urothelial cancer, head and neck squamous cell carcinoma and triple-negative breast cancer, run by Lumara Bio Oncologics GmbH, now recruiting.","summary":"A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05706129 by Lumara Bio Oncologics GmbH, with 270 participants planned, started 2023-03-14 and due to reach its primary completion in 2027-06. Interventions recorded: [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05706129","url":"https://clinicaltrials.gov/study/NCT05706129"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc","pancreatic","colorectal","urothelial","head-and-neck","tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05706129","phase":"1/2","setting":"A Multicenter, Open-Label, Non-Randomized Phase 1/2 Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors","sponsor":"Lumara Bio Oncologics GmbH","started":"2023-03-14","startedType":"actual","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05428969","kind":"trial","name":"A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies","aka":["BEXMAB"],"tldr":"A phase 1/2 trial of Azacitidine and Venetoclax in acute myeloid leukaemia, chronic myelomonocytic leukaemia and MDS/MPN overlap neoplasms and myelodysplastic syndromes / neoplasms, run by Faron Pharmaceuticals Ltd, active and no longer recruiting.","summary":"A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies is a phase 1/2 interventional study registered as NCT05428969 by Faron Pharmaceuticals Ltd, with 181 participants enrolled, started 2022-06-02 and due to reach its primary completion in 2027-03. Interventions recorded: Bexmarilimab, Azacitidine and Venetoclax.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05428969","url":"https://clinicaltrials.gov/study/NCT05428969"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","cmml","mds"],"sections":[],"technologies":[],"targets":[],"drugs":["azacitidine","venetoclax","bexmarilimab"],"companies":["faron-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05428969","phase":"1/2","setting":"A Phase I/II Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of the Clever-1 Antibody Bexmarilimab in Combination With Standard of Care Therapy in Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia or Acute Myeloid Leukemia","sponsor":"Faron Pharmaceuticals Ltd","started":"2022-06-02","startedType":"actual","enrolled":181,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03888105","kind":"trial","name":"A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treat","aka":["ELM-2","Odronextamab in relapsed or refractory B-cell non-Hodgkin lymphoma"],"tldr":"A phase 2 trial of Odronextamab in hodgkin lymphoma and non-hodgkin lymphoma, run by Regeneron Pharmaceuticals, active and no longer recruiting.","summary":"A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies is a phase 2 interventional study registered as NCT03888105 by Regeneron Pharmaceuticals, with 515 participants enrolled, started 2019-11-13 and due to reach its primary completion in 2026-06-17. Interventions recorded: Odronextamab. Conditions listed: B-cell Non-Hodgkin Lymphoma (B-NHL). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03888105","url":"https://clinicaltrials.gov/study/NCT03888105"}],"tags":["ctgov-ingest"],"related":["lymphoma-roadmap","paper-elm-2-odronextamab-follicular-ann-oncol-2024"],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma","follicular-lymphoma","dlbcl"],"sections":[],"technologies":["t-cell-engager","bispecific-antibody"],"targets":["cd20","cd3"],"drugs":["odronextamab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-elm-2-odronextamab-follicular-ann-oncol-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03888105","phase":"2","setting":"An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma","sponsor":"Regeneron Pharmaceuticals","result":"In the follicular lymphoma cohort, objective response 80.0 per cent and complete response 73.4 per cent, with median duration of complete response 25.1 months and median progression-free survival 20.7 months.","started":"2019-11-13","startedType":"actual","yearReported":2024,"enrolled":515,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06109272","kind":"trial","name":"A Study to Assess the Dose, Adverse Events, and Change in Disease Activity of Livmoniplimab as an Intravenous (IV) Solution in Combination With Budigalimab as an IV Solution in Adult Participants With Hepatocellular Carcinoma (HCC)","aka":["LIVIGNO-2"],"tldr":"A phase 2/3 trial testing Budigalimab in hepatocellular carcinoma, active and no longer recruiting.","summary":"A Study to Assess the Dose, Adverse Events, and Change in Disease Activity of Livmoniplimab as an Intravenous (IV) Solution in Combination With Budigalimab as an IV Solution in Adult Participants With Hepatocellular Carcinoma (HCC) is a phase 2/3 interventional study registered as NCT06109272, led by AbbVie, and active but no longer recruiting on the registry. Official title: A Phase 2/3, Randomised Study to Evaluate the Dose Optimization, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab in Subjects With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Treatment. Planned enrolment is 660 participants (estimated). The study started in 2024-01-11 and primary completion is expected in 2030-09. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06109272","url":"https://clinicaltrials.gov/study/NCT06109272"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":["budigalimab","livmoniplimab"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registry status on 22 September 2026: Active, not recruiting (registry record last updated 22 September 2026; primary completion expected January 2027)."],"nct":"NCT06109272","phase":"2/3","setting":"A Phase 2/3, Randomized Study to Evaluate the Dose Optimization, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab in Subjects With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Treatment","sponsor":"AbbVie","started":"2024-01-11","startedType":"actual","enrolled":660,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00718549","kind":"trial","name":"A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL)","aka":[],"tldr":"A phase 3 trial of Cladribine, Cyclophosphamide and Rituximab in Leukaemia, run by Hoffmann-La Roche, completed.","summary":"A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL) is a phase 3 interventional study registered as NCT00718549 by Hoffmann-La Roche, with 128 participants recorded, started 2009-07-21 and reaching its primary completion in 2015-09-14. Interventions recorded: Cladribine, Cyclophosphamide, Rituximab. Conditions recorded: Lymphocytic Leukemia, Chronic.\n\nLinked to the drug Cladribine because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00718549","url":"https://clinicaltrials.gov/study/NCT00718549"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["cladribine","cyclophosphamide","rituximab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00718549","phase":"3","setting":"A Randomized, Open Label Study to Assess the Effect of Maintenance Treatment With Mabthera (Rituximab) Versus No Treatment, After Induction Treatment With Rituximab, Cladribine and Cyclophosphamide (RCC) on Progression-Free Survival in Previously Untreated Patients With Progressive B-Cell Chronic Lymphocytic Leukemia","sponsor":"Hoffmann-La Roche","started":"2009-07-21","startedType":"actual","yearReported":2018,"enrolled":128,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Fee Survival (PFS) Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL","primary":true,"unit":"years","arms":[{"name":"Maintenance Arm: Rituximab","n":33,"note":"Median and Upper Limit could not be calculated due to insufficient number of participants who had an event.; Figures from the ClinicalTrials.gov results section (first posted 2018-08-20), not from a publication"},{"name":"Observation Arm: No Intervention","n":33,"value":2.1,"note":"95% CI 1.9 to NA"},{"name":"All Randomized Participants","n":66,"value":3.1,"note":"95% CI 2.2 to NA"}],"source":"https://clinicaltrials.gov/study/NCT00718549?tab=results"}]},{"id":"nct05503797","kind":"trial","name":"A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations","aka":[],"tldr":"A phase 2 trial of Plixorafenib in advanced solid tumours, run by Fore Biotherapeutics, now recruiting.","summary":"A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations is a phase 2 interventional study registered as NCT05503797 by Fore Biotherapeutics, with 254 participants planned, started 2023-02-21 and due to reach its primary completion in 2027-12-31. Interventions recorded: Plixorafenib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05503797","url":"https://clinicaltrials.gov/study/NCT05503797"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["braf"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05503797","phase":"2","setting":"A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants With Cancer Harboring BRAF Alterations","sponsor":"Fore Biotherapeutics","started":"2023-02-21","startedType":"actual","enrolled":254,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06631989","kind":"trial","name":"A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of WSD0922-FU in non-small-cell lung cancer, run by Wayshine Biopharm, Inc., now recruiting.","summary":"A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT06631989 by Wayshine Biopharm, Inc., with 100 participants planned, started 2024-09-04 and due to reach its primary completion in 2027-06-30. Interventions recorded: WSD0922-FU.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06631989","url":"https://clinicaltrials.gov/study/NCT06631989"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["wayshine-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06631989","phase":"1/2","setting":"A Phase I/II Multicenter, Open Label, Single-arm Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of WSD0922-FU in the Treatment of Advanced Non-small Cell Lung Cancer","sponsor":"Wayshine Biopharm, Inc.","started":"2024-09-04","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06868485","kind":"trial","name":"A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of WSD0922-FU Tablets, Dose level A in non-small-cell lung cancer, run by Wayshine Biopharm, Inc., now recruiting.","summary":"A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT06868485 by Wayshine Biopharm, Inc., with 40 participants planned, started 2025-08-18 and due to reach its primary completion in 2027-09-30. Interventions recorded: WSD0922-FU Tablets, Dose level A and WSD0922-FU Tablets, Dose level B.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06868485","url":"https://clinicaltrials.gov/study/NCT06868485"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":["wayshine-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06868485","phase":"2","setting":"A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation","sponsor":"Wayshine Biopharm, Inc.","started":"2025-08-18","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04224493","kind":"trial","name":"A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus ","aka":["Symphony-1"],"tldr":"A phase 3 trial of Tazemetostat, Lenalidomide, Rituximab in follicular lymphoma, run by Epizyme, Inc., active and no longer recruiting.","summary":"A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma. is a phase 3 interventional study registered as NCT04224493 by Epizyme, Inc., with 599 participants enrolled, started 2020-06-11 and due to reach its primary completion in 2027-02-13. Interventions recorded: Tazemetostat, Tazemetostat, Placebo oral tablet, Lenalidomide, Rituximab. Conditions listed: Relapsed/Refractory Follicular Lymphoma, Follicular Lymphoma, Refractory Follicular Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04224493","url":"https://clinicaltrials.gov/study/NCT04224493"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["epigenetic-drugs","monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["tazemetostat","lenalidomide","rituximab"],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04224493","phase":"3","setting":"Symphony-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study Of Tazemetostat Or Placebo In Combination With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular Lymphoma","sponsor":"Epizyme, Inc.","started":"2020-06-11","startedType":"actual","enrolled":599,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06669247","kind":"trial","name":"A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Mult","aka":["COSTIMM"],"tldr":"A phase 1/2 trial of Linvoseltamab in multiple myeloma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT06669247 by Regeneron Pharmaceuticals, with 186 participants planned, started 2024-12-11 and due to reach its primary completion in 2033-11-11. Interventions recorded: Linvoseltamab, REGN7945+Linvoseltamab. Conditions listed: Relapsed/Refractory Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06669247","url":"https://clinicaltrials.gov/study/NCT06669247"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["linvoseltamab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06669247","phase":"1/2","setting":"A First-in-Human (FIH) Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN7945, an Anti-CD38 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma","sponsor":"Regeneron Pharmaceuticals","started":"2024-12-11","startedType":"actual","enrolled":186,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04931654","kind":"trial","name":"A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer","aka":[],"tldr":"A phase 1/2 trial of AZD7789 in non-small-cell lung cancer and gastric & gastro-oesophageal junction cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer is a phase 1/2 interventional study registered as NCT04931654 by AstraZeneca, with 136 participants enrolled, started 2021-09-28 and due to reach its primary completion in 2024-12-04. Interventions recorded: AZD7789.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04931654","url":"https://clinicaltrials.gov/study/NCT04931654"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","gastric"],"sections":[],"technologies":[],"targets":[],"drugs":["azd7789"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04931654","phase":"1/2","setting":"A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Participants With Advanced or Metastatic Solid Tumors.","sponsor":"AstraZeneca","started":"2021-09-28","startedType":"actual","enrolled":136,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02677922","kind":"trial","name":"A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy","aka":[],"tldr":"A phase 1/2 trial of Azacitidine in acute myeloid leukaemia, run by Celgene, active and no longer recruiting.","summary":"A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy is a phase 1/2 interventional study registered as NCT02677922 by Celgene, with 130 participants enrolled, started 2016-06-03 and due to reach its primary completion in 2018-08-02. Interventions recorded: AG-120, Azacitidine and AG-221. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02677922","url":"https://clinicaltrials.gov/study/NCT02677922"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-idh"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["azacitidine"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02677922","phase":"1/2","setting":"A Phase 1b/2 Open-Label, Randomized Study of 2 Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine: Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus SC Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia Harboring an IDH1 or an IDH2 Mutation, Respectively, Who Are Not Candidates to Receive Intensive Induction Chemotherapy","sponsor":"Celgene","started":"2016-06-03","startedType":"actual","yearReported":2022,"enrolled":130,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Response Rate: Phase 2 (Randomized Stage)","primary":true,"unit":"%","arms":[{"name":"Phase 2 Randomized Stage: AG-221 (100mg) + AZA","n":68,"value":73.5,"note":"95% CI 61.4 to 83.5; Figures from the ClinicalTrials.gov results section (first posted 2022-11-22), not from a publication"},{"name":"Phase 2 Randomized Stage: AZA Monotherapy","n":33,"value":36.4,"note":"95% CI 20.4 to 54.9"}],"p":"0.0003","source":"https://clinicaltrials.gov/study/NCT02677922?tab=results"},{"endpoint":"Overall Survival: Phase 2 (Randomized Stage)","unit":"months","arms":[{"name":"Phase 2 Randomized Stage: AG-221 (100mg) + AZA","n":68,"value":22,"note":"95% CI 14.6 to NA; Figures from the ClinicalTrials.gov results section (first posted 2022-11-22), not from a publication"},{"name":"Phase 2 Randomized Stage: AZA Monotherapy","n":33,"value":22.3,"note":"95% CI 11.9 to NA"}],"p":"0.9720","source":"https://clinicaltrials.gov/study/NCT02677922?tab=results"}]},{"id":"nct04817007","kind":"trial","name":"A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)","aka":[],"tldr":"A phase 1/2 trial of Ruxolitinib and Fedratinib in myeloproliferative neoplasms, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis) is a phase 1/2 interventional study registered as NCT04817007 by Bristol-Myers Squibb, with 216 participants enrolled, started 2021-03-22 and due to reach its primary completion in 2028-08-31. Interventions recorded: BMS-986158, Ruxolitinib and Fedratinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04817007","url":"https://clinicaltrials.gov/study/NCT04817007"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","primary-myelofibrosis"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ruxolitinib","fedratinib"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04817007","phase":"1/2","setting":"A Phase 1b/2 Study of BMS-986158 Monotherapy and in Combination With Either Ruxolitinib or Fedratinib in Participants With DIPSS-Intermediate or High Risk Myelofibrosis","sponsor":"Bristol-Myers Squibb","started":"2021-03-22","startedType":"actual","enrolled":216,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07325136","kind":"trial","name":"A Study to Assess the Safety and Tolerability of BMS-986525 Alone and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung ","aka":[],"tldr":"A phase 1/2 trial of PM8002 in small-cell lung cancer, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study to Assess the Safety and Tolerability of BMS-986525 Alone and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT07325136 by Bristol-Myers Squibb, with 240 participants planned, started 2026-02-03 and due to reach its primary completion in 2029-04-23. Interventions recorded: BMS-986525, Pumitamig. Conditions listed: Relapsed/Refractory Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07325136","url":"https://clinicaltrials.gov/study/NCT07325136"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07325136","phase":"1/2","setting":"A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung Cancer","sponsor":"Bristol-Myers Squibb","started":"2026-02-03","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06155084","kind":"trial","name":"A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients","aka":[],"tldr":"A phase 1/2 trial of HP518 - Dose Escalation in prostate cancer, run by Hinova Pharmaceuticals Inc., now recruiting.","summary":"A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients is a phase 1/2 interventional study registered as NCT06155084 by Hinova Pharmaceuticals Inc., with 84 participants planned, started 2023-12-26 and due to reach its primary completion in 2026-03. Interventions recorded: HP518 - Dose Escalation and HP518 -Dose Expansion.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06155084","url":"https://clinicaltrials.gov/study/NCT06155084"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hinova-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06155084","phase":"1/2","setting":"A Phase I/II Open-Label Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer in China","sponsor":"Hinova Pharmaceuticals Inc.","started":"2023-12-26","startedType":"actual","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06969430","kind":"trial","name":"A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)","aka":[],"tldr":"A phase 1/2 trial of Debio 1562M in acute myeloid leukaemia, run by Debiopharm International SA, now recruiting.","summary":"A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML) is a phase 1/2 interventional study registered as NCT06969430 by Debiopharm International SA, with 154 participants planned, started 2025-05-30 and due to reach its primary completion in 2031-11. Interventions recorded: Debio 1562M.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06969430","url":"https://clinicaltrials.gov/study/NCT06969430"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["debiopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06969430","phase":"1/2","setting":"A Phase 1/2, First-in-human, Multicenter, Open-label Trial Evaluating the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)","sponsor":"Debiopharm International SA","started":"2025-05-30","startedType":"actual","enrolled":154,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07680764","kind":"trial","name":"A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pu","aka":[],"tldr":"A phase 2 trial of PM8002, Pemetrexed, Cisplatin in non-small-cell lung cancer and small-cell lung cancer, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) is a phase 2 interventional study registered as NCT07680764 by Bristol-Myers Squibb, with 160 participants planned, started 2026-08-31 and due to reach its primary completion in 2028-09-15. Interventions recorded: Pumitamig, Imzokitug, Pemetrexed, Cisplatin, Carboplatin. Conditions listed: Locally Advanced Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07680764","url":"https://clinicaltrials.gov/study/NCT07680764"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002","pemetrexed","cisplatin","carboplatin","paclitaxel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07680764","phase":"2","setting":"A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Bristol-Myers Squibb","started":"2026-08-31","startedType":"estimated","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06898450","kind":"trial","name":"A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.","aka":[],"tldr":"A phase 1/2 trial of NDI-219216 in advanced solid tumours, run by Nimbus Wadjet, Inc., now recruiting.","summary":"A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors. is a phase 1/2 interventional study registered as NCT06898450 by Nimbus Wadjet, Inc., with 134 participants planned, started 2025-03-31 and due to reach its primary completion in 2031-10. Interventions recorded: NDI-219216.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06898450","url":"https://clinicaltrials.gov/study/NCT06898450"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ndi-219216"],"companies":["nimbus-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06898450","phase":"1/2","setting":"A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NDI-219216 in Patients With Advanced Solid Tumors With/Without Microsatellite Instability and/or Deficient Mismatch Repair","sponsor":"Nimbus Wadjet, Inc.","started":"2025-03-31","startedType":"actual","enrolled":134,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06035497","kind":"trial","name":"A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)","aka":["GOLSEEK-3"],"tldr":"A phase 1/2 trial of BMS-986369 in peripheral T-cell lymphomas, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3) is a phase 1/2 interventional study registered as NCT06035497 by Bristol-Myers Squibb, with 85 participants enrolled, started 2023-11-20 and due to reach its primary completion in 2027-01-30. Interventions recorded: BMS-986369.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06035497","url":"https://clinicaltrials.gov/study/NCT06035497"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06035497","phase":"1/2","setting":"A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)","sponsor":"Bristol-Myers Squibb","started":"2023-11-20","startedType":"actual","enrolled":85,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07213817","kind":"trial","name":"A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours","aka":[],"tldr":"A phase 1/2 trial of IPN60300 in advanced solid tumours, run by Ipsen, now recruiting.","summary":"A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours is a phase 1/2 interventional study registered as NCT07213817 by Ipsen, with 114 participants planned, started 2025-12-05 and due to reach its primary completion in 2028-10-30. Interventions recorded: IPN60300.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07213817","url":"https://clinicaltrials.gov/study/NCT07213817"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07213817","phase":"1/2","setting":"An Open-Label, Phase I/II First-in-Human, Dose Escalation, Dose Optimisation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 as Single Agent in Adult Participants With Locally Advanced or Metastatic Solid Tumours.","sponsor":"Ipsen","started":"2025-12-05","startedType":"actual","enrolled":114,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07213830","kind":"trial","name":"A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies","aka":[],"tldr":"A phase 1/2 trial of IPN01203 in advanced solid tumours, run by Ipsen, now recruiting.","summary":"A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies is a phase 1/2 interventional study registered as NCT07213830 by Ipsen, with 102 participants planned, started 2026-02-06 and due to reach its primary completion in 2032-07-14. Interventions recorded: IPN01203.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07213830","url":"https://clinicaltrials.gov/study/NCT07213830"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07213830","phase":"1/2","setting":"An Open-label, Phase I/II First in Human, Dose Escalation, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Participants With Locally Advanced or Metastatic Solid Tumours Who Have Progressed on or After Immune Checkpoint Inhibitor Therapies","sponsor":"Ipsen","started":"2026-02-06","startedType":"actual","enrolled":102,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07128199","kind":"trial","name":"A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection","aka":["REZILIENT4"],"tldr":"A phase 3 trial testing Zipalertinib in non-small-cell lung cancer, active and no longer recruiting.","summary":"A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumour Resection is a phase 3 interventional study registered as NCT07128199, led by Taiho Oncology, and active but no longer recruiting on the registry. Official title: A Randomised, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Versus Placebo in Early Stage NSCLC Patients With Uncommon EGFR Mutations Following Complete Tumour Resection (REZILIENT4). Planned enrolment is 360 participants (estimated). The study started in 2025-12-22 and primary completion is expected in 2029-10-01. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07128199","url":"https://clinicaltrials.gov/study/NCT07128199"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["zipalertinib"],"companies":["taiho-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07128199","phase":"3","setting":"A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Versus Placebo in Early Stage NSCLC Patients With Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)","sponsor":"Taiho Oncology","started":"2025-12-22","startedType":"actual","enrolled":360,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07178717","kind":"trial","name":"A Study to Characterize Encorafenib Plus Cetuximab as Rechallenge Treatment for BRAF V600E-mutant Metastatic Colorectal Cancer Patients After Previous Therapy W","aka":["REFISH"],"tldr":"A phase 2 trial of bevacizumab (glioblastoma use) and encorafenib in colorectal cancer, run by Vall d'Hebron Institute of Oncology, not yet recruiting.","summary":"A Study to Characterize Encorafenib Plus Cetuximab as Rechallenge Treatment for BRAF V600E-mutant Metastatic Colorectal Cancer Patients After Previous Therapy With BRAF Inhibitors-based Combinations is a phase 2, interventional study registered as NCT07178717 by Vall d'Hebron Institute of Oncology, with a registry enrolment figure of 25 participants, started 2025-10 and due to reach its primary completion in 2028-02. Interventions recorded: Rechalange with bevacizumab + encorafenib. Conditions listed: Colo-rectal Cancer. Primary outcome: Progression free survival. Colorectal eligibility wording from the registry: \"5 x ULN is allowed if direct (conjugated) ≤1\". Sites: Spain. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07178717","url":"https://clinicaltrials.gov/study/NCT07178717"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","braf-v600e-colorectal"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["bevacizumab-glioma","encorafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07178717","phase":"2","setting":"A Phase 2, Single-Arm Study of Encorafenib Plus Cetuximab as Rechallenge Treatment of BRAF V600E-mutant Metastatic Colorectal Cancer Patients After Previous Therapy With BRAF Inhibitors-based Combinations: the RefIsh Trial","sponsor":"Vall d'Hebron Institute of Oncology","started":"2025-10","startedType":"estimated","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06311721","kind":"trial","name":"A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Amgen, active and no longer recruiting.","summary":"A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06311721 by Amgen, with 315 participants enrolled, started 2024-09-09 and due to reach its primary completion in 2028-01-10. Interventions recorded: ABP 234, Pembrolizumab (US), Pembrolizumab (EU). Conditions listed: Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06311721","url":"https://clinicaltrials.gov/study/NCT06311721"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06311721","phase":"3","setting":"A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer","sponsor":"Amgen","started":"2024-09-09","startedType":"actual","enrolled":315,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05794906","kind":"trial","name":"A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer","aka":["ARASTEP"],"tldr":"A phase 3 trial of Darolutamide in prostate cancer, run by Bayer, active and no longer recruiting.","summary":"A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies is a phase 3 interventional study registered as NCT05794906 by Bayer, with 985 participants enrolled, started 2023-04-03 and due to reach its primary completion in 2027-07-30. Interventions recorded: Darolutamide (BAY1841788, Nubeqa), Placebo matching darolutamide, ADT. Conditions listed: Biochemically Recurrent Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05794906","url":"https://clinicaltrials.gov/study/NCT05794906"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-bcr"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["darolutamide"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05794906","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer","sponsor":"Bayer","started":"2023-04-03","startedType":"actual","enrolled":985,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06265428","kind":"trial","name":"A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer","aka":["Dynasty-Breast01"],"tldr":"A phase 3 trial of Trastuzumab pamirtecan run by DualityBio Inc. in her2-positive breast cancer, active.","summary":"A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer is a phase 3 interventional study registered as NCT06265428 by DualityBio Inc., with 228 participants enrolled, started 2024-01-29. Conditions listed: HER2-positive Breast Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06265428","url":"https://clinicaltrials.gov/study/NCT06265428"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-pamirtecan"],"companies":["dualitybio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06265428","phase":"3","setting":"A Phase III, Multicenter, Open-label, Randomized Study to Compare DB-1303 Versus T-DM1 in Patients With HER2-positive Unresectable/Metastatic Breast Cancer Who Have Been Treated With Trastuzumab and a Taxane (Dynasty-Breast01)","sponsor":"DualityBio Inc.","started":"2024-01-29","startedType":"actual","enrolled":228,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06939595","kind":"trial","name":"A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer","aka":[],"tldr":"A phase 3 trial of Pembrolizumab in non-small-cell lung cancer, run by Celltrion, active and no longer recruiting.","summary":"A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer is a phase 3 interventional study registered as NCT06939595 by Celltrion, with 225 participants enrolled, started 2025-01-30 and due to reach its primary completion in 2027-02. Interventions recorded: CT-P51 and EU-approved Keytruda.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06939595","url":"https://clinicaltrials.gov/study/NCT06939595"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["celltrion"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06939595","phase":"3","setting":"A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P51 and Keytruda in Combination With Platinum-Pemetrexed Chemotherapy in Patients With Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer","sponsor":"Celltrion","started":"2025-01-30","startedType":"actual","enrolled":225,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06091865","kind":"trial","name":"A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Pa","aka":["OLYMPIA-3"],"tldr":"A phase 3 trial of Odronextamab, Rituximab, Cyclophosphamide in diffuse large b-cell lymphoma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma is a phase 3 interventional study registered as NCT06091865 by Regeneron Pharmaceuticals, with 904 participants planned, started 2023-12-13 and due to reach its primary completion in 2028-03-30. Interventions recorded: Odronextamab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine. Conditions listed: Diffuse Large B-cell Lymphoma (DLBCL). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06091865","url":"https://clinicaltrials.gov/study/NCT06091865"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["monoclonal-antibody","t-cell-engager"],"targets":[],"drugs":["odronextamab","rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06091865","phase":"3","setting":"A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (ODRO-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)","sponsor":"Regeneron Pharmaceuticals","started":"2023-12-13","startedType":"actual","enrolled":904,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05827016","kind":"trial","name":"A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly","aka":["EXCALIBER-Maintenance"],"tldr":"A phase 3 trial of Iberdomide, Lenalidomide in multiple myeloma, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma is a phase 3 interventional study registered as NCT05827016 by Bristol-Myers Squibb, with 1230 participants enrolled, started 2023-06-22 and due to reach its primary completion in 2029-03-15. Interventions recorded: Iberdomide, Lenalidomide. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05827016","url":"https://clinicaltrials.gov/study/NCT05827016"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-transplant-eligible"],"sections":[],"technologies":["celmods","protac-degrader"],"targets":[],"drugs":["iberdomide","lenalidomide"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05827016","phase":"3","setting":"A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)","sponsor":"Bristol-Myers Squibb","started":"2023-06-22","startedType":"actual","enrolled":1230,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07393282","kind":"trial","name":"A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)","aka":["LINKER-SMM2"],"tldr":"A phase 3 trial of Linvoseltamab, Daratumumab in multiple myeloma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) is a phase 3 interventional study registered as NCT07393282 by Regeneron Pharmaceuticals, with 270 participants planned, started 2026-05-21 and due to reach its primary completion in 2033-07-27. Interventions recorded: Linvoseltamab, Daratumumab. Conditions listed: High Risk Smoldering Multiple Myeloma (HR-SMM). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07393282","url":"https://clinicaltrials.gov/study/NCT07393282"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","smouldering-myeloma"],"sections":[],"technologies":["monoclonal-antibody","t-cell-engager"],"targets":[],"drugs":["linvoseltamab","daratumumab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07393282","phase":"3","setting":"A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma","sponsor":"Regeneron Pharmaceuticals","started":"2026-05-21","startedType":"actual","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06952478","kind":"trial","name":"A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone","aka":[],"tldr":"A phase 3 trial of Daratumumab in multiple myeloma, run by Celltrion, now recruiting.","summary":"A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma is a phase 3 interventional study registered as NCT06952478 by Celltrion, with 486 participants planned, started 2025-08-12 and due to reach its primary completion in 2027-11-15. Interventions recorded: CT-P44(Daratumumab), Darzalex Faspro(Daratumumab). Conditions listed: Refractory or Relapsed Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06952478","url":"https://clinicaltrials.gov/study/NCT06952478"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["daratumumab"],"companies":["celltrion"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06952478","phase":"3","setting":"A Double-Blind, Randomized, Active-Controlled, Parallel-group, Phase 1/3 Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma","sponsor":"Celltrion","started":"2025-08-12","startedType":"actual","enrolled":486,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06687369","kind":"trial","name":"A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell L","aka":["BENITO"],"tldr":"A phase 3 trial of Pemetrexed, Carboplatin, Cisplatin in non-small-cell lung cancer and small-cell lung cancer, run by mAbxience Research S.L., active and no longer recruiting.","summary":"A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study) is a phase 3 interventional study registered as NCT06687369 by mAbxience Research S.L., with 726 participants planned, started 2024-12-30 and due to reach its primary completion in 2026-08-31. Interventions recorded: MB12 (Proposed Pembrolizumab Biosimilar), EU-sourced Keytruda®, US-sourced Keytruda®, Pemetrexed, Carboplatin. Conditions listed: Non Squamous Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06687369","url":"https://clinicaltrials.gov/study/NCT06687369"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pemetrexed","carboplatin","cisplatin"],"companies":["mabxience-research-s-l"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06687369","phase":"3","setting":"Randomized, Multicenter, Multinational, Double-Blind Study to Compare the Pharmacokinetics, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Combination With Chemotherapy for the Treatment of Patients With Advanced Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (BENITO Study)","sponsor":"mAbxience Research S.L.","started":"2024-12-30","startedType":"actual","enrolled":726,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07079228","kind":"trial","name":"A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial testing QLS31905 in pancreatic ductal adenocarcinoma, now recruiting.","summary":"A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer is a phase 3 interventional study registered as NCT07079228, led by Qilu Pharmaceutical, and recruiting on the registry. Official title: A Phase 3, Multi-Center, Double-blind, Randomised Study of QLS31905 Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-Line Treatment in Participants With Claudin (CLDN)18.2-Positive Advanced Pancreatic Cancer. Planned enrolment is 602 participants (estimated). The study started in 2025-09-08 and primary completion is expected in 2028-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07079228","url":"https://clinicaltrials.gov/study/NCT07079228"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["qls31905"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07079228","phase":"3","setting":"A Phase 3, Multi-Center, Double-blind, Randomized Study of QLS31905 Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-Line Treatment in Participants With Claudin (CLDN)18.2-Positive Advanced Pancreatic Cancer","sponsor":"Qilu Pharmaceutical","started":"2025-09-08","startedType":"actual","enrolled":602,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06952504","kind":"trial","name":"A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participan","aka":["TroFuse-033"],"tldr":"A phase 3 trial of Pembrolizumab, Carboplatin, Paclitaxel / nab-paclitaxel in endometrial cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29) is a phase 3 interventional study registered as NCT06952504 by Merck Sharp & Dohme LLC, with 1123 participants planned, started 2025-05-22 and due to reach its primary completion in 2032-05-24. Interventions recorded: Pembrolizumab, Carboplatin, Paclitaxel, Docetaxel, Sacituzumab Tirumotecan. Conditions listed: Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06952504","url":"https://clinicaltrials.gov/study/NCT06952504"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":[],"drugs":["pembrolizumab","carboplatin","paclitaxel","docetaxel","sacituzumab-tirumotecan","cisplatin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06952504","phase":"3","setting":"A Phase 3 Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-05-22","startedType":"actual","enrolled":1123,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06459180","kind":"trial","name":"A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With","aka":["TroFuse-020"],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Pemetrexed, Tisotumab vedotin in cervical cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20) is a phase 3 interventional study registered as NCT06459180 by Merck Sharp & Dohme LLC, with 686 participants planned, started 2024-07-24 and due to reach its primary completion in 2028-06-15. Interventions recorded: Sacituzumab Tirumotecan, Pemetrexed, Tisotumab Vedotin, Topotecan, Vinorelbine. Conditions listed: Cervical Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06459180","url":"https://clinicaltrials.gov/study/NCT06459180"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","pemetrexed","tisotumab-vedotin","topotecan","vinorelbine","gemcitabine"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06459180","phase":"3","setting":"A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)","sponsor":"Merck Sharp & Dohme LLC","started":"2024-07-24","startedType":"actual","enrolled":686,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07566052","kind":"trial","name":"A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation","aka":[],"tldr":"A phase 3 trial testing Setidegrasib in non-small-cell lung cancer, now recruiting.","summary":"A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation is a phase 3 interventional study registered as NCT07566052, led by Astellas Pharma Global Development, and recruiting on the registry. Official title: A Randomised, Open-label, Phase 3 Study of Setidegrasib (ASP3082) Versus Docetaxel in Participants With KRAS G12D-mutated Locally Advanced (Unresectable) or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on or After Platinum Based Chemotherapy and Checkpoint Inhibitor Therapy (CPI). Planned enrolment is 356 participants (estimated). The study started in 2026-04-28 and primary completion is expected in 2030-06-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07566052","url":"https://clinicaltrials.gov/study/NCT07566052"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["setidegrasib"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07566052","phase":"3","setting":"A Randomized, Open-label, Phase 3 Study of Setidegrasib (ASP3082) Versus Docetaxel in Participants With KRAS G12D-mutated Locally Advanced (Unresectable) or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on or After Platinum Based Chemotherapy and Checkpoint Inhibitor Therapy (CPI)","sponsor":"Astellas Pharma Global Development","started":"2026-04-28","startedType":"actual","enrolled":356,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04293562","kind":"trial","name":"A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations","aka":[],"tldr":"A phase 3 trial of Crisantaspase, Asparaginase, Cytarabine, Daunorubicin, Dexrazoxane, Etoposide, Fludeoxyglucose F-18, Gemtuzumab ozogamicin, Gilteritinib, CPX-351, Methotrexate and Mitoxantrone in Acute myeloid leukaemia, run by Children's Oncology Group, now recruiting.","summary":"A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations is a phase 3 interventional study registered as NCT04293562 by Children's Oncology Group, with 1400 participants planned, started 2020-07-21 and due to reach its primary completion in 2029-06-30. Interventions recorded: Allogeneic Hematopoietic Stem Cell Transplantation, Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cytarabine, Daunorubicin Hydrochloride, Dexrazoxane Hydrochloride, Etoposide, Fludeoxyglucose F-18, Gemtuzumab Ozogamicin, Gilteritinib Fumarate, Liposome-encapsulated Daunorubicin-Cytarabine, Magnetic Resonance Imaging, Methotrexate, Mitoxantrone Hydrochloride, Positron Emission Tomography, Questionnaire Administration, Therapeutic Hydrocortisone. Conditions recorded: Acute Myeloid Leukemia.\n\nLinked to the drug Crisantaspase because the registry names it among its interventions and Acute myeloid leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04293562","url":"https://clinicaltrials.gov/study/NCT04293562"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":["crisantaspase","asparaginase","cytarabine","daunorubicin","dexrazoxane","etoposide","fludeoxyglucose-f18","gemtuzumab-ozogamicin","gilteritinib","cpx-351","methotrexate","mitoxantrone"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04293562","phase":"3","setting":"A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations","sponsor":"Children's Oncology Group","started":"2020-07-21","startedType":"actual","enrolled":1400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07063745","kind":"trial","name":"A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","aka":["MountainTAP-29"],"tldr":"A phase 2/3 trial testing Navlimetostat in non-small-cell lung cancer, now recruiting.","summary":"A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion is a phase 2/3 interventional study registered as NCT07063745, led by Bristol-Myers Squibb, and recruiting on the registry. Official title: A Randomised Phase 2/3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion. Planned enrolment is 590 participants (estimated). The study started in 2026-01-02 and primary completion is expected in 2031-08-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07063745","url":"https://clinicaltrials.gov/study/NCT07063745"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["navlimetostat"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07063745","phase":"2/3","setting":"A Randomized Phase 2/3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","sponsor":"Bristol-Myers Squibb","started":"2026-01-02","startedType":"actual","enrolled":590,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06764485","kind":"trial","name":"A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer","aka":[],"tldr":"A phase 3 trial testing BMS-986365 in prostate cancer, active and no longer recruiting.","summary":"A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer is a phase 3 interventional study registered as NCT06764485, led by Celgene, and active but no longer recruiting on the registry. Official title: A Phase 3, Two-part, Randomised, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge. Planned enrolment is 960 participants (estimated). The study started in 2025-03-13 and primary completion is expected in 2027-09-12. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06764485","url":"https://clinicaltrials.gov/study/NCT06764485"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["bms-986365"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06764485","phase":"3","setting":"A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge","sponsor":"Celgene","started":"2025-03-13","startedType":"actual","enrolled":960,"enrolledBasis":"registry","outcomes":[]},{"id":"quintessential-2","kind":"trial","name":"A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)","aka":["QUINTESSENTIAL-2"],"tldr":"A phase 3 trial testing Arlocabtagene Autoleucel in multiple myeloma, now recruiting.","summary":"A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2) is a phase 3 interventional study registered as NCT06615479, led by Juno Therapeutics, a Bristol-Myers Squibb with Celgene, and recruiting on the registry. Official title: A Phase 3, Randomised, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma. Planned enrolment is 440 participants (estimated). The study started in 2025-03-12 and primary completion is expected in 2027-12-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06615479","url":"https://clinicaltrials.gov/study/NCT06615479"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["arlocabtagene-autoleucel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06615479","phase":"3","setting":"A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma","sponsor":"Juno Therapeutics, a Bristol-Myers Squibb","started":"2025-03-12","startedType":"actual","enrolled":440,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06646276","kind":"trial","name":"A Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS)","aka":["TIGOS"],"tldr":"A phase 3 trial testing Atigotatug in non-small-cell lung cancer, now recruiting.","summary":"A Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS) is a phase 3 interventional study registered as NCT06646276, led by Bristol-Myers Squibb, and recruiting on the registry. Official title: A Randomised, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (Atigotatug+Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide vs Atezolizumab in Combination With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS). Planned enrolment is 530 participants (estimated). The study started in 2025-02-25 and primary completion is expected in 2028-04-06. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06646276","url":"https://clinicaltrials.gov/study/NCT06646276"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["atigotatug"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06646276","phase":"3","setting":"A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (Atigotatug+Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide vs Atezolizumab in Combination With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS)","sponsor":"Bristol-Myers Squibb","started":"2025-02-25","startedType":"actual","enrolled":530,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04603807","kind":"trial","name":"A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases","aka":[],"tldr":"A phase 3 trial of Entrectinib and Crizotinib in non-small-cell lung cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases is a phase 3 interventional study registered as NCT04603807 by Hoffmann-La Roche, with 217 participants enrolled, started 2021-09-30 and due to reach its primary completion in 2026-09-30. Interventions recorded: Entrectinib and Crizotinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04603807","url":"https://clinicaltrials.gov/study/NCT04603807"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","ros1-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["entrectinib","crizotinib"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04603807","phase":"3","setting":"Randomized, Open Label, Multicenter, Phase III Study of Entrectinib Versus Crizotinib in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring ROS1 Gene Rearrangements With and Without Central Nervous System Metastases","sponsor":"Hoffmann-La Roche","started":"2021-09-30","startedType":"actual","enrolled":217,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06911502","kind":"trial","name":"A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Rela","aka":[],"tldr":"A phase 3 trial of Golcadomide, Rituximab, Lenalidomide in follicular lymphoma, run by Celgene, now recruiting.","summary":"A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy (GOLSEEK-4) is a phase 3 interventional study registered as NCT06911502 by Celgene, with 400 participants planned, started 2025-07-28 and due to reach its primary completion in 2028-04-24. Interventions recorded: Golcadomide, Rituximab, Lenalidomide, Cyclophosphamide, Doxorubicin. Conditions listed: Follicular Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06911502","url":"https://clinicaltrials.gov/study/NCT06911502"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["golcadomide","rituximab","lenalidomide","cyclophosphamide","doxorubicin","vincristine"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06911502","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) Vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy","sponsor":"Celgene","started":"2025-07-28","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06045806","kind":"trial","name":"A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alo","aka":["KarMMa-9"],"tldr":"A phase 3 trial of Idecabtagene vicleucel, Lenalidomide, Fludarabine in multiple myeloma, run by Celgene, active and no longer recruiting.","summary":"A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation is a phase 3 interventional study registered as NCT06045806 by Celgene, with 79 participants enrolled, started 2023-10-16 and due to reach its primary completion in 2025-08-11. Interventions recorded: idecabtagene vicleucel, Lenalidomide, Fludarabine, Cyclophosphamide. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06045806","url":"https://clinicaltrials.gov/study/NCT06045806"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-transplant-eligible"],"sections":[],"technologies":["car-t","protac-degrader"],"targets":[],"drugs":["idecabtagene-vicleucel","lenalidomide","fludarabine","cyclophosphamide"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06045806","phase":"3","setting":"A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)","sponsor":"Celgene","started":"2023-10-16","startedType":"actual","enrolled":79,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06022861","kind":"trial","name":"A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma","aka":[],"tldr":"A phase 3 trial of Cisplatin and Nivolumab in oesophageal cancer, run by Shandong Boan Biotechnology Co., Ltd, now recruiting.","summary":"A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma is a phase 3 interventional study registered as NCT06022861 by Shandong Boan Biotechnology Co., Ltd, with 510 participants planned, started 2023-10-12 and due to reach its primary completion in 2025-06. Interventions recorded: LY01015, Fluorouracil, Cisplatin and Opdivo®.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06022861","url":"https://clinicaltrials.gov/study/NCT06022861"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal","oesophageal-squamous-cell-carcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin","nivolumab"],"companies":["luye-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06022861","phase":"3","setting":"A Randomized, Double-blind, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of LY01015 and Opdivo®（Nivolumab Injection）Combined Respectively With Fluorouracil Plus Cisplatin in Participants With Advanced or Metastatic Esophageal Squamous Cell Carcinoma.","sponsor":"Shandong Boan Biotechnology Co., Ltd","started":"2023-10-12","startedType":"actual","enrolled":510,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05197426","kind":"trial","name":"A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission","aka":[],"tldr":"A phase 2 trial of Azacitidine in acute myeloid leukaemia, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission is a phase 2 interventional study registered as NCT05197426 by Bristol-Myers Squibb, with 19 participants enrolled, started 2022-01-17 and due to reach its primary completion in 2025-01-27. Interventions recorded: Oral Azacitidine. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05197426","url":"https://clinicaltrials.gov/study/NCT05197426"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["azacitidine"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05197426","phase":"2","setting":"A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Subjects With Acute Myeloid Leukemia in Complete Remission","sponsor":"Bristol-Myers Squibb","started":"2022-01-17","startedType":"actual","yearReported":2026,"enrolled":19,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence Free Survival (RFS)","primary":true,"unit":"months","arms":[{"name":"Treatment 1","n":12,"note":"Insufficient number of participants with events to calculate via KM methodology; Figures from the ClinicalTrials.gov results section (first posted 2026-02-11), not from a publication"},{"name":"Treatment 2","n":7,"value":7.4,"note":"range 1.4 to NA"}],"source":"https://clinicaltrials.gov/study/NCT05197426?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Treatment 1","n":12,"note":"Insufficient number of participants with events to calculate via KM methodology; Figures from the ClinicalTrials.gov results section (first posted 2026-02-11), not from a publication"},{"name":"Treatment 2","n":7,"value":15.1,"note":"range 12.3 to NA"}],"source":"https://clinicaltrials.gov/study/NCT05197426?tab=results"}]},{"id":"nct07803783","kind":"trial","name":"A Study to Compare the Efficacy and Safety of YL201 With Standard Chemotherapy in Patients With Metastatic Pancreatic Cancer After Failure of Gemcitabine-Based","aka":[],"tldr":"A phase 3 trial of YL201, liposomal irinotecan, fluorouracil (5-FU) and fLOT (5-FU, leucovorin, oxaliplatin, docetaxel) in pancreatic cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd., not yet recruiting.","summary":"A Study to Compare the Efficacy and Safety of YL201 With Standard Chemotherapy in Patients With Metastatic Pancreatic Cancer After Failure of Gemcitabine-Based Systemic Chemotherapy is a phase 3, randomised interventional study registered as NCT07803783 by MediLink Therapeutics (Suzhou) Co., Ltd., with a registry enrolment figure of 320 participants, started 2026-10 and due to reach its primary completion in 2029-01. Interventions recorded: Tambotatug pelitecan; Liposomal irinotecan; 5 Fluorouracil; Leucovorin. Conditions listed: Metastatic Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma (PDAC). Primary outcome: PFS by BICR; OS. Pancreatic eligibility wording from the registry: \"Participants must have histologically or cytologically confirmed incurable metastatic pancreatic ductal adenocarcinoma (PDAC)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07803783","url":"https://clinicaltrials.gov/study/NCT07803783"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["yl201","liposomal-irinotecan","fluorouracil","flot"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07803783","phase":"3","setting":"A Randomized, Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of YL201 Versus Liposomal Irinotecan in Combination With 5-Fluorouracil/Leucovorin in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed Prior Gemcitabine-based Systemic Therapy","sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","started":"2026-10","startedType":"estimated","enrolled":320,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06561386","kind":"trial","name":"A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous N","aka":[],"tldr":"A phase 3 trial of Nivolumab, Pembrolizumab, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1% is a phase 3 interventional study registered as NCT06561386 by Bristol-Myers Squibb, with 1000 participants planned, started 2024-10-07 and due to reach its primary completion in 2030-07-30. Interventions recorded: Nivolumab, Relatlimab, Pembrolizumab, Carboplatin, Pemetrexed. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06561386","url":"https://clinicaltrials.gov/study/NCT06561386"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","pembrolizumab","carboplatin","pemetrexed","cisplatin"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06561386","phase":"3","setting":"A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%","sponsor":"Bristol-Myers Squibb","started":"2024-10-07","startedType":"actual","enrolled":1000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06847334","kind":"trial","name":"A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Shanghai Henlius Biotech, not yet recruiting.","summary":"A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT06847334 by Shanghai Henlius Biotech, with a registry enrolment figure of 772 participants, started 2025-04-27 and due to reach its primary completion in 2027-04-09. Interventions recorded: HLX17; US-sourced Keytruda®; EU-sourced Keytruda®. Conditions listed: Non-Squamous Non-Small Cell Lung Cancer. Primary outcome: Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d); Area under the serum concentration-time curve within a dosing interval at steady state (AUCss); Best Objective Response Rate (BORR) assessed by Independent Radiology Review Committee (IRRC) based on RECIST v1.1. Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed diagnosis of stage IV inoperable to surgery or radiotherapy (AJCC 8th edition) non-squamous NSCLC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06847334","url":"https://clinicaltrials.gov/study/NCT06847334"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06847334","phase":"3","setting":"A Multicentre, Randomized, Double-Blind, Parallel-Controlled Integrated Phase I/III Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic Profile of HLX17 Vs. Keytruda® (US-sourced Keytruda® and EU-sourced Keytruda®) in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer","sponsor":"Shanghai Henlius Biotech","started":"2025-04-27","startedType":"estimated","enrolled":772,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06348199","kind":"trial","name":"A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-s","aka":[],"tldr":"A phase 3 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Samsung Bioepis Co., Ltd., active and no longer recruiting.","summary":"A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT06348199 by Samsung Bioepis Co., Ltd., with 555 participants enrolled, started 2024-03-12 and due to reach its primary completion in 2026-03-10. Interventions recorded: SB27, Keytruda. Conditions listed: Non-small Cell Lung Cancer Stage IV. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06348199","url":"https://clinicaltrials.gov/study/NCT06348199"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["samsung-bioepis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06348199","phase":"3","setting":"A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 (Proposed Pembrolizumab Biosimilar) and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer","sponsor":"Samsung Bioepis Co., Ltd.","started":"2024-03-12","startedType":"actual","enrolled":555,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07005336","kind":"trial","name":"A Study to Compare Uliledlimab Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy in Patients With Previously Untr","aka":[],"tldr":"A phase 2 trial of Uliledlimab, Sintilimab, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by TJ Biopharma Co., Ltd., active and no longer recruiting.","summary":"A Study to Compare Uliledlimab Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT07005336 by TJ Biopharma Co., Ltd., with 150 participants planned, started 2025-01-09 and due to reach its primary completion in 2026-08-30. Interventions recorded: Uliledlimab, Sintilimab, Pemetrexed, Gemcitabine, Cisplatin Or Carboplatin. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07005336","url":"https://clinicaltrials.gov/study/NCT07005336"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["uliledlimab","sintilimab","pemetrexed","gemcitabine"],"companies":["tj-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07005336","phase":"2","setting":"A Phase II, Randomized, Multicenter, Open-Label Study to Compare Uliledlimab Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer","sponsor":"TJ Biopharma Co., Ltd.","started":"2025-01-09","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06984588","kind":"trial","name":"A Study to Compare Uliledlimab Combined With Toripalimab, Toripalimab Monotherapy, and Pembrolizumab Monotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1- and CD73- Selected Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2/3 trial testing Uliledlimab in non-small-cell lung cancer, active and no longer recruiting.","summary":"A Study to Compare Uliledlimab Combined With Toripalimab, Toripalimab Monotherapy, and Pembrolizumab Monotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1- and CD73- Selected Non-Small Cell Lung Cancer is a phase 2/3 interventional study registered as NCT06984588, led by TJ Biopharma, and active but no longer recruiting on the registry. Official title: A Phase II/III, Randomised, Multicenter, Open-Label Study to Compare Uliledlimab Combined With Toripalimab, Toripalimab Monotherapy, and Pembrolizumab Monotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1- and CD73- Selected Non-Small Cell Lung Cancer. Planned enrolment is 450 participants (estimated). The study started in 2024-03-28 and primary completion is expected in 2028-08-05. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06984588","url":"https://clinicaltrials.gov/study/NCT06984588"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["uliledlimab"],"companies":["tj-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06984588","phase":"2/3","setting":"A Phase II/III, Randomized, Multicenter, Open-Label Study to Compare Uliledlimab Combined With Toripalimab, Toripalimab Monotherapy, and Pembrolizumab Monotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1- and CD73- Selected Non-Small Cell Lung Cancer","sponsor":"TJ Biopharma","started":"2024-03-28","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05963074","kind":"trial","name":"A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia","aka":["TAILOR"],"tldr":"A phase 2 trial of Ibrutinib and Venetoclax in chronic lymphocytic leukaemia, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia is a phase 2 interventional study registered as NCT05963074 by Janssen Research & Development, LLC, with 333 participants enrolled, started 2024-05-30 and due to reach its primary completion in 2027-12-15. Interventions recorded: Ibrutinib and Venetoclax.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05963074","url":"https://clinicaltrials.gov/study/NCT05963074"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ibrutinib","venetoclax"],"companies":["johnson-johnson","abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05963074","phase":"2","setting":"Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia","sponsor":"Janssen Research & Development, LLC","started":"2024-05-30","startedType":"actual","enrolled":333,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02773030","kind":"trial","name":"A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple","aka":[],"tldr":"A phase 1/2 trial of Iberdomide, Dexamethasone, Daratumumab in multiple myeloma, run by Celgene, active and no longer recruiting.","summary":"A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma is a phase 1/2 interventional study registered as NCT02773030 by Celgene, with 466 participants enrolled, started 2016-10-14 and due to reach its primary completion in 2024-05-09. Interventions recorded: CC-220, Dexamethasone, Daratumumab, Bortezomib, Carfilzomib. Conditions listed: Multiple Myeloma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02773030","url":"https://clinicaltrials.gov/study/NCT02773030"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["celmods","protac-degrader"],"targets":[],"drugs":["iberdomide","dexamethasone","daratumumab","bortezomib","carfilzomib"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02773030","phase":"1/2","setting":"Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 As Monotherapy and in Combination With Other Treatments in Subjects With Multiple Myeloma","sponsor":"Celgene","started":"2016-10-14","startedType":"actual","yearReported":2026,"enrolled":466,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Response Rate (ORR) in Cohort D and Cohort H2","primary":true,"unit":"%","arms":[{"name":"Cohort D: Treatment 1","n":107,"value":26.2,"note":"95% CI 18.1 to 35.6; Figures from the ClinicalTrials.gov results section (first posted 2026-03-20), not from a publication"},{"name":"Cohort H2","n":5,"value":20,"note":"95% CI 0.5 to 71.6"}],"source":"https://clinicaltrials.gov/study/NCT02773030?tab=results"},{"endpoint":"Progression Free Survival","unit":"weeks","arms":[{"name":"Cohort A: Total","n":29,"value":12.29,"note":"range 0.1 to 395.0; Figures from the ClinicalTrials.gov results section (first posted 2026-03-20), not from a publication"},{"name":"Cohort B: Total","n":90,"value":14.71,"note":"range 0.1 to 247.0"},{"name":"Cohort D: Total","n":107,"value":12.14,"note":"range 0.1 to 150.1"},{"name":"Cohort E: Total","n":50,"value":20.71,"note":"range 2.1 to 269.1"},{"name":"Cohort F: Total","n":29,"value":15.14,"note":"range 0.1 to 258.1"},{"name":"Cohort G: Total","n":16,"value":48.57,"note":"range 4.1 to 246.3"},{"name":"Cohort H1","n":6,"value":26.14,"note":"range 5.3 to 213.1"},{"name":"Cohort H2","n":5,"value":22.14,"note":"range 8.3 to 46.7"},{"name":"Cohort I","n":41,"value":10.14,"note":"range 0.1 to 84.4"},{"name":"Cohort J: Total","n":18,"value":107,"note":"range 0.1 to 127.9"},{"name":"Cohort K","n":75,"value":57.14,"note":"range 0.1 to 81.3"}],"source":"https://clinicaltrials.gov/study/NCT02773030?tab=results"}]},{"id":"nct06598007","kind":"trial","name":"A Study to Determine the Effect of CT3001 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of FOLFOX, FLOT, CAPOX in colorectal cancer and pancreatic ductal adenocarcinoma, run by Crossignal Therapeutics, Inc., now recruiting.","summary":"A Study to Determine the Effect of CT3001 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06598007 by Crossignal Therapeutics, Inc., with 78 participants planned, started 2024-09-20 and due to reach its primary completion in 2027-06-20. Interventions recorded: CT3001, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin). Conditions listed: Solid Tumor, Adult, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06598007","url":"https://clinicaltrials.gov/study/NCT06598007"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["folfox","flot","capox","ct3001"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06598007","phase":"1/2","setting":"A Phase 1/2 First-In-Human, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CT3001 in Patients With Advanced Solid Tumors","sponsor":"Crossignal Therapeutics, Inc.","started":"2024-09-20","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03989414","kind":"trial","name":"A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Tre","aka":[],"tldr":"A phase 1/2 trial of Mezigdomide, Bortezomib, Dexamethasone in multiple myeloma, run by Celgene, active and no longer recruiting.","summary":"A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) is a phase 1/2 interventional study registered as NCT03989414 by Celgene, with 424 participants planned, started 2019-09-30 and due to reach its primary completion in 2026-11-30. Interventions recorded: CC-92480, Bortezomib, Dexamethasone, Daratumumab, Carfilzomib. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03989414","url":"https://clinicaltrials.gov/study/NCT03989414"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["celmods","protac-degrader"],"targets":[],"drugs":["mezigdomide","bortezomib","dexamethasone","daratumumab","carfilzomib","elotuzumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03989414","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)","sponsor":"Celgene","started":"2019-09-30","startedType":"actual","enrolled":424,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06988488","kind":"trial","name":"A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatama","aka":[],"tldr":"A phase 1/2 trial of Elranatamab, Mezigdomide, Dexamethasone in multiple myeloma, run by Celgene, now recruiting.","summary":"A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT06988488 by Celgene, with 62 participants planned, started 2025-10-07 and due to reach its primary completion in 2027-05-31. Interventions recorded: Elranatamab, Mezigdomide, Dexamethasone. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06988488","url":"https://clinicaltrials.gov/study/NCT06988488"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["celmods","protac-degrader","t-cell-engager"],"targets":[],"drugs":["elranatamab","mezigdomide","dexamethasone"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06988488","phase":"1/2","setting":"A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma","sponsor":"Celgene","started":"2025-10-07","startedType":"actual","enrolled":62,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05944224","kind":"trial","name":"A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.","aka":[],"tldr":"A phase 1/2 trial of SPH4336 and Cadonilimab in advanced solid tumours, run by Shanghai Pharmaceuticals Holding Co., Ltd, now recruiting.","summary":"A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors. is a phase 1/2 interventional study registered as NCT05944224 by Shanghai Pharmaceuticals Holding Co., Ltd, with 63 participants planned, started 2023-10-17 and due to reach its primary completion in 2026-12-31. Interventions recorded: SPH4336 and Cadonilimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05944224","url":"https://clinicaltrials.gov/study/NCT05944224"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["sph4336","cadonilimab"],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05944224","phase":"1/2","setting":"A Randomized, Open-label, Phase Ib/IIa Clinical Study to Evaluate the Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors, Including Advanced Well Differentiated/Dedifferentiated Liposarcoma.","sponsor":"Shanghai Pharmaceuticals Holding Co., Ltd","started":"2023-10-17","startedType":"actual","enrolled":63,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06196736","kind":"trial","name":"A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer","aka":[],"tldr":"A phase 3 trial of 9MW2821 in bladder & urothelial cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd., now recruiting.","summary":"A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer is a phase 3 interventional study registered as NCT06196736 by Mabwell (Shanghai) Bioscience Co., Ltd., with 432 participants planned, started 2023-12-29 and due to reach its primary completion in 2026-09. Interventions recorded: 9MW2821 and Chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06196736","url":"https://clinicaltrials.gov/study/NCT06196736"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["mabwell-shanghai-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06196736","phase":"3","setting":"An Open-label, Randomized Phase 3 Study to Evaluate 9MW2821 vs Investigator's Choice of Chemotherapy in Subjects With Locally Advanced or Metastatic Urothelial Cancer Who Have Previously Received PD-(L)1 Inhibitor and Platinum-containing Chemotherapy","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","started":"2023-12-29","startedType":"actual","enrolled":432,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06692166","kind":"trial","name":"A Study to Evaluate 9MW2821 Versus Treatment of Physician's Choice for Subjects With Recurrent or Metastatic Cervical Cancer","aka":[],"tldr":"A phase 3 trial of 9MW2821 in cervical cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd., now recruiting.","summary":"A Study to Evaluate 9MW2821 Versus Treatment of Physician's Choice for Subjects With Recurrent or Metastatic Cervical Cancer is a phase 3 interventional study registered as NCT06692166 by Mabwell (Shanghai) Bioscience Co., Ltd., with 420 participants planned, started 2024-09-10 and due to reach its primary completion in 2027-12-09. Interventions recorded: 9MW2821 and Chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06692166","url":"https://clinicaltrials.gov/study/NCT06692166"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["mabwell-shanghai-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06692166","phase":"3","setting":"A Randomized, Open-label, Phase 3 Study to Evaluate 9MW2821 vs Treatment of Physician's Choice in Subjects With Recurrent or Metastatic Cervical Cancer Who Progressed on or After Platinum-based Chemotherapy","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","started":"2024-09-10","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06054555","kind":"trial","name":"A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma","aka":[],"tldr":"A phase 3 trial of Nivolumab in melanoma, run by Amgen, active and no longer recruiting.","summary":"A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma is a phase 3 interventional study registered as NCT06054555 by Amgen, with 633 participants enrolled, started 2023-11-02 and due to reach its primary completion in 2028-01-25. Interventions recorded: ABP 206, Nivolumab. Conditions listed: Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06054555","url":"https://clinicaltrials.gov/study/NCT06054555"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06054555","phase":"3","setting":"A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma","sponsor":"Amgen","started":"2023-11-02","startedType":"actual","enrolled":633,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07029737","kind":"trial","name":"A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain","aka":["SOUND-MCL"],"tldr":"A phase 2 trial of Acalabrutinib, Rituximab in mantle cell lymphoma, run by AstraZeneca, now recruiting.","summary":"A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain is a phase 2 interventional study registered as NCT07029737 by AstraZeneca, with 55 participants planned, started 2025-09-05 and due to reach its primary completion in 2027-12-31. Interventions recorded: Acalabrutinib + R-CHOP standard of care, Acalabrutinib combination with Rituximab, Acalabrutinib monotherapy. Conditions listed: Mantle-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07029737","url":"https://clinicaltrials.gov/study/NCT07029737"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["acalabrutinib","rituximab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07029737","phase":"2","setting":"The SOUND-MCL Study: A Single-arm, Open-label, Multicenter, Phase II Study of Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain","sponsor":"AstraZeneca","started":"2025-09-05","startedType":"actual","enrolled":55,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07365241","kind":"trial","name":"A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial testing ABBV-706 in non-small-cell lung cancer, now recruiting.","summary":"A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer is a phase 3 interventional study registered as NCT07365241, led by AbbVie, and recruiting on the registry. Official title: A Phase 3 Randomised, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 Versus Standard of Care in Subjects With Relapsed/Refractory Small Cell Lung Cancer (SCLC). Planned enrolment is 531 participants (estimated). The study started in 2026-07-02 and primary completion is expected in 2030-09. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07365241","url":"https://clinicaltrials.gov/study/NCT07365241"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["abbv-706"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07365241","phase":"3","setting":"A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 Versus Standard of Care in Subjects With Relapsed/Refractory Small Cell Lung Cancer (SCLC)","sponsor":"AbbVie","started":"2026-07-02","startedType":"actual","enrolled":531,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05201248","kind":"trial","name":"A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Th","aka":[],"tldr":"A phase 1/2 trial of Epcoritamab, Cyclophosphamide, Rituximab in hodgkin lymphoma and non-hodgkin lymphoma, run by Genmab, active and no longer recruiting.","summary":"A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma is a phase 1/2 interventional study registered as NCT05201248 by Genmab, with 49 participants enrolled, started 2022-03-10 and due to reach its primary completion in 2026-09. Interventions recorded: Epcoritamab, Cyclophosphamide, Rituximab, Doxorubicin, Vincristine. Conditions listed: B-Cell Non-Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05201248","url":"https://clinicaltrials.gov/study/NCT05201248"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["epcoritamab","cyclophosphamide","rituximab","doxorubicin","vincristine","prednisone"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05201248","phase":"1/2","setting":"Phase 1b/2, Open-Label Trial to Evaluate Safety and Preliminary Efficacy of Epcoritamab As Monotherapy or Combined With Standard-of-Care Therapies in Chinese Subjects With B-Cell Non-Hodgkin Lymphoma","sponsor":"Genmab","started":"2022-03-10","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05283720","kind":"trial","name":"A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neopl","aka":[],"tldr":"A phase 2 trial of Epcoritamab, Lenalidomide, Ibrutinib in hodgkin lymphoma and non-hodgkin lymphoma, run by Genmab, active and no longer recruiting.","summary":"A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma is a phase 2 interventional study registered as NCT05283720 by Genmab, with 264 participants enrolled, started 2022-06-14 and due to reach its primary completion in 2032-11. Interventions recorded: Epcoritamab, Lenalidomide, Ibrutinib, Rituximab, Cyclophosphamide. Conditions listed: Non-Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05283720","url":"https://clinicaltrials.gov/study/NCT05283720"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["epcoritamab","lenalidomide","ibrutinib","rituximab","cyclophosphamide","prednisone"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05283720","phase":"2","setting":"Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma","sponsor":"Genmab","started":"2022-06-14","startedType":"actual","enrolled":264,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05451810","kind":"trial","name":"A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refr","aka":[],"tldr":"A phase 2 trial of Epcoritamab in diffuse large b-cell lymphoma and follicular lymphoma, run by Genmab, active and no longer recruiting.","summary":"A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma is a phase 2 interventional study registered as NCT05451810 by Genmab, with 184 participants planned, started 2022-08-17 and due to reach its primary completion in 2027-03. Interventions recorded: Epcoritamab. Conditions listed: Diffuse Large B-Cell Lymphoma, Classic Follicular Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05451810","url":"https://clinicaltrials.gov/study/NCT05451810"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl","follicular-lymphoma"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["epcoritamab"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05451810","phase":"2","setting":"A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) When Administered in the Outpatient Setting","sponsor":"Genmab","started":"2022-08-17","startedType":"actual","enrolled":184,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07285148","kind":"trial","name":"A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of osimertinib in lung cancer, run by Beijing Pearl Biotechnology Limited Liability Company, not yet recruiting.","summary":"A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer is a phase 1/2, randomised interventional study registered as NCT07285148 by Beijing Pearl Biotechnology Limited Liability Company, with a registry enrolment figure of 253 participants, started 2026-06 and due to reach its primary completion in 2029-12. Interventions recorded: ANS014004 + PLB1004; ANS014004 + Osimertinib. Conditions listed: Non-Small Cell Lung Cancer; EGFR Mutation; Metastatic Lung Cancer; MET Alteration. Primary outcome: Number of participants with dose-limiting toxicity (DLT) during the DLT observation period (Phase Ib Dose Escalation); Maximum tolerated dose (MTD) of ANS014004 in combination with PLB1004 (Phase Ib Dose Escalation); Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 (Phase Ib Do. Lung eligibility wording from the registry: \"Patients with histologically or cytologically confirmed diagnosis of unresectable locally advanced (Stage IIIB and IIIC) or metastatic (Stage IV) NSCLC (according to the lung cancer staging criteria, refer to the eighth edition of the American Joint Committee on Cancer \\[AJCC\\] Lung Cancer Staging)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07285148","url":"https://clinicaltrials.gov/study/NCT07285148"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":["beijing-pearl-biotechnology-limited-liability-company","avistone-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07285148","phase":"1/2","setting":"An Open-label, Multicenter Phase Ib/II Study to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of ANS014004 in Combination With EGFR-TKI in Patients With EGFR Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Beijing Pearl Biotechnology Limited Liability Company","started":"2026-06","startedType":"estimated","enrolled":253,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07749586","kind":"trial","name":"A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by Arvinas Inc., now recruiting.","summary":"A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07749586 by Arvinas Inc., with 499 participants planned, started 2026-07-29 and due to reach its primary completion in 2031-03-31. Interventions recorded: ARV-6723, Pembrolizumab and SOC.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07749586","url":"https://clinicaltrials.gov/study/NCT07749586"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["arvinas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07749586","phase":"1/2","setting":"A Phase 1/2 Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ARV-6723 Administered as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","sponsor":"Arvinas Inc.","started":"2026-07-29","startedType":"actual","enrolled":499,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07023731","kind":"trial","name":"A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation","aka":[],"tldr":"A phase 1/2 trial of ARV-806 in advanced solid tumours, run by Arvinas Inc., active and no longer recruiting.","summary":"A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation is a phase 1/2 interventional study registered as NCT07023731 by Arvinas Inc., with 76 participants enrolled, started 2025-05-29 and due to reach its primary completion in 2026-11-30. Interventions recorded: ARV-806.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07023731","url":"https://clinicaltrials.gov/study/NCT07023731"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["arvinas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07023731","phase":"1/2","setting":"A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-806 in Participants With KRAS G12D Mutated Advanced Solid Tumors","sponsor":"Arvinas Inc.","started":"2025-05-29","startedType":"actual","enrolled":76,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06590246","kind":"trial","name":"A Study to Evaluate C-CAR031 in Glypican-3 (GPC3)+ Advanced/Recurrent Hepatocellular Carcinoma (HCC)","aka":[],"tldr":"A phase 1/2 trial of Armored and GPC3-targeted autologous CAR T-cell in hepatocellular carcinoma, run by Shanghai AbelZeta Ltd., now recruiting.","summary":"A Study to Evaluate C-CAR031 in Glypican-3 (GPC3)+ Advanced/Recurrent Hepatocellular Carcinoma (HCC) is a phase 1/2 interventional study registered as NCT06590246 by Shanghai AbelZeta Ltd., with 121 participants planned, started 2024-09-30 and due to reach its primary completion in 2030-04-30. Interventions recorded: Armored and GPC3-targeted autologous CAR T-cell.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06590246","url":"https://clinicaltrials.gov/study/NCT06590246"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shanghai-abelzeta"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06590246","phase":"1/2","setting":"Phase I/II Clinical Study of Armored and GPC3-targeted Autologous Chimeric Antigen Receptor (CAR) T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Recurrent Hepatocellular Carcinoma","sponsor":"Shanghai AbelZeta Ltd.","started":"2024-09-30","startedType":"actual","enrolled":121,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04639180","kind":"trial","name":"A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recur","aka":[],"tldr":"A phase 3 trial of Camrelizumab, Rivoceranib in hepatocellular carcinoma, run by Jiangsu HengRui Medicine Co., Ltd., active and no longer recruiting.","summary":"A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation is a phase 3 interventional study registered as NCT04639180 by Jiangsu HengRui Medicine Co., Ltd., with 687 participants enrolled, started 2021-04-01 and due to reach its primary completion in 2026-07-31. Interventions recorded: Camrelizumab, Rivoceranib (Apatinib). Conditions listed: Hepatocellular Carcinoma (HCC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04639180","url":"https://clinicaltrials.gov/study/NCT04639180"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-early"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["camrelizumab","rivoceranib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04639180","phase":"3","setting":"A Randomized, Open-Label, Multi-Center, Phase Ⅲ Clinical Study of Camrelizumab Plus Rivoceranib (Apatinib) as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2021-04-01","startedType":"actual","enrolled":687,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04765059","kind":"trial","name":"A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)","aka":["COMPEL"],"tldr":"A phase 3 trial of Osimertinib in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC) is a phase 3 interventional study registered as NCT04765059 by AstraZeneca, with 98 participants enrolled, started 2021-09-12 and due to reach its primary completion in 2024-10-28. Interventions recorded: Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin, Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatin. Conditions listed: Non-small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04765059","url":"https://clinicaltrials.gov/study/NCT04765059"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04765059-esmo-open-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04765059","phase":"3","setting":"A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Platinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients With EGFRm, Locally Advanced or Metastatic NSCLC Who Have Progressed Extracranially Following First-Line Osimertinib Therapy (COMPEL)","sponsor":"AstraZeneca","started":"2021-09-12","startedType":"actual","yearReported":2026,"enrolled":98,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin","n":49,"value":8.4,"note":"95% CI 5.75 to 11.83; Figures from the ClinicalTrials.gov results section (first posted 2026-01-13), not from a publication"},{"name":"Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin","n":49,"value":4.4,"note":"95% CI 3.52 to 5.55"}],"hr":0.43,"ci":[0.27,0.7],"source":"https://clinicaltrials.gov/study/NCT04765059?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin","n":49,"value":15.9,"note":"95% CI 12.39 to 20.83; Figures from the ClinicalTrials.gov results section (first posted 2026-01-13), not from a publication"},{"name":"Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin","n":49,"value":9.8,"note":"95% CI 8.38 to 17.25"}],"hr":0.71,"ci":[0.42,1.23],"source":"https://clinicaltrials.gov/study/NCT04765059?tab=results"}]},{"id":"nct07522073","kind":"trial","name":"A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma","aka":["DAWN-303"],"tldr":"A phase 3 trial testing INCB161734 in pancreatic ductal adenocarcinoma, now recruiting.","summary":"A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma is a phase 3 interventional study registered as NCT07522073, led by Incyte with Qiagen Manchester, and recruiting on the registry. Official title: A Randomised, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303). Planned enrolment is 588 participants (estimated). The study started in 2026-04-09 and primary completion is expected in 2028-09-15. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07522073","url":"https://clinicaltrials.gov/study/NCT07522073"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["incb161734"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07522073","phase":"3","setting":"A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)","sponsor":"Incyte","started":"2026-04-09","startedType":"actual","enrolled":588,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07460375","kind":"trial","name":"A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of LCB02A in advanced solid tumours, run by LigaChem Biosciences, Inc., now recruiting.","summary":"A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07460375 by LigaChem Biosciences, Inc., with 191 participants planned, started 2026-08 and due to reach its primary completion in 2030-02. Interventions recorded: LCB02A.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07460375","url":"https://clinicaltrials.gov/study/NCT07460375"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["lcb02a"],"companies":["ligachem-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07460375","phase":"1/2","setting":"A First-in-Human Phase 1/2, Dose Escalation and Dose Expansion Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of Claudin18.2 (CLDN18.2)-Directed Antibody-Drug Conjugate (ADC) LCB02A in Patients With CLDN18.2-positive Advanced Solid Tumors","sponsor":"LigaChem Biosciences, Inc.","started":"2026-08","startedType":"estimated","enrolled":191,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06954961","kind":"trial","name":"A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial testing D-0502 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer is a phase 3 interventional study registered as NCT06954961, led by InventisBio, and recruiting on the registry. Official title: A Randomised, Parallel-controlled, Open-label, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of D-0502 With Fulvestrant in Patients With Previously Treated ER-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer. Planned enrolment is 640 participants (estimated). The study started in 2022-09-15 and primary completion is expected in 2026-11-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06954961","url":"https://clinicaltrials.gov/study/NCT06954961"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["d-0502"],"companies":["inventisbio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06954961","phase":"3","setting":"A Randomized, Parallel-controlled, Open-label, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of D-0502 With Fulvestrant in Patients With Previously Treated ER-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer","sponsor":"InventisBio","started":"2022-09-15","startedType":"actual","enrolled":640,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07564401","kind":"trial","name":"A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy","aka":[],"tldr":"A phase 1/2 trial of DJI136 in small-cell lung cancer, run by Novartis Pharmaceuticals, now recruiting.","summary":"A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy is a phase 1/2 interventional study registered as NCT07564401 by Novartis Pharmaceuticals, with 80 participants planned, started 2026-06-16 and due to reach its primary completion in 2031-03-03. Interventions recorded: DJI136. Conditions listed: Extensive-stage Small Cell Lung Cancer (ES-SCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07564401","url":"https://clinicaltrials.gov/study/NCT07564401"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["dji136"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07564401","phase":"1/2","setting":"A Phase I/II Open-label Study of DJI136, a DLL3-targeted CAR-T Therapy, in Adult Patients With ES-SCLC","sponsor":"Novartis Pharmaceuticals","started":"2026-06-16","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07149857","kind":"trial","name":"A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel","aka":["CARTITUDE-10"],"tldr":"A phase 2 trial of Ciltacabtagene autoleucel, Cyclophosphamide, Fludarabine in multiple myeloma, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel is a phase 2 interventional study registered as NCT07149857 by Janssen Research & Development, LLC, with 60 participants planned, started 2025-10-03 and due to reach its primary completion in 2028-04-12. Interventions recorded: Cilta-cel, Cyclophosphamide, Induction therapy, Fludarabine. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07149857","url":"https://clinicaltrials.gov/study/NCT07149857"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["ciltacabtagene-autoleucel","cyclophosphamide","fludarabine"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07149857","phase":"2","setting":"A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel","sponsor":"Janssen Research & Development, LLC","started":"2025-10-03","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06065748","kind":"trial","name":"A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)","aka":[],"tldr":"A phase 3 trial of Giredestrant, Fulvestrant, Abemaciclib, Palbociclib and Ribociclib in HR-positive / HER2-negative breast cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) is a phase 3 interventional study registered as NCT06065748 by Hoffmann-La Roche, with 1050 participants enrolled, started 2023-12-11 and due to reach its primary completion in 2028-04-20. Interventions recorded: Giredestrant, Fulvestrant, Abemaciclib, Palbociclib, Ribociclib and LHRH Agonist.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06065748","url":"https://clinicaltrials.gov/study/NCT06065748"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["giredestrant","fulvestrant","abemaciclib","palbociclib","ribociclib"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06065748","phase":"3","setting":"A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy","sponsor":"Hoffmann-La Roche","started":"2023-12-11","startedType":"actual","enrolled":1050,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07554521","kind":"trial","name":"A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States","aka":[],"tldr":"A phase 2 trial of Tislelizumab, Capecitabine, Fluorouracil (5-FU) and Oxaliplatin in gastric & gastro-oesophageal junction cancer and oesophageal cancer, run by BeOne Medicines, now recruiting.","summary":"A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States is a phase 2 interventional study registered as NCT07554521 by BeOne Medicines, with 30 participants planned, started 2026-04-30 and due to reach its primary completion in 2031-12-31. Interventions recorded: Tislelizumab, Capecitabine, 5-fluorouracil (5-FU), Oxaliplatin and Leucovorin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07554521","url":"https://clinicaltrials.gov/study/NCT07554521"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","esophageal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab","capecitabine","fluorouracil","oxaliplatin"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07554521","phase":"2","setting":"An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy in a First-Line Setting for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in US Racial and Ethnic Minority Patients","sponsor":"BeOne Medicines","started":"2026-04-30","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06754644","kind":"trial","name":"A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC","aka":[],"tldr":"A phase 3 trial testing QL2107 in non-small-cell lung cancer, now recruiting.","summary":"A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC is a phase 3 interventional study registered as NCT06754644, led by Qilu Pharmaceutical, and recruiting on the registry. Official title: A Randomised, Double-blind, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of QL2107 Versus Keytruda® in Combination With Chemotherapy in the Treatment of Metastatic Non-squamous Non-small-cell Lung Cancer. Planned enrolment is 808 participants (estimated). The study started in 2025-01-15 and primary completion is expected in 2026-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06754644","url":"https://clinicaltrials.gov/study/NCT06754644"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ql2107"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06754644","phase":"3","setting":"A Randomized, Double-blind, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of QL2107 Versus Keytruda® in Combination With Chemotherapy in the Treatment of Metastatic Non-squamous Non-small-cell Lung Cancer","sponsor":"Qilu Pharmaceutical","started":"2025-01-15","startedType":"actual","enrolled":808,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05645107","kind":"trial","name":"A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","aka":["EXCELL"],"tldr":"A phase 3 trial of Xembify in chronic lymphocytic leukaemia and non-Hodgkin lymphoma, run by Grifols Therapeutics LLC, now recruiting.","summary":"A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma is a phase 3 interventional study registered as NCT05645107 by Grifols Therapeutics LLC, with 386 participants planned, started 2022-12-26 and due to reach its primary completion in 2029-08. Interventions recorded: Xembify and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05645107","url":"https://clinicaltrials.gov/study/NCT05645107"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["grifols"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05645107","phase":"3","setting":"A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","sponsor":"Grifols Therapeutics LLC","started":"2022-12-26","startedType":"actual","enrolled":386,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04225117","kind":"trial","name":"A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)","aka":[],"tldr":"A phase 2 trial of Enfortumab vedotin and Pembrolizumab in advanced solid tumours, run by Astellas Pharma Global Development, Inc., active and no longer recruiting.","summary":"A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202) is a phase 2 interventional study registered as NCT04225117 by Astellas Pharma Global Development, Inc., with 329 participants enrolled, started 2020-03-10 and due to reach its primary completion in 2025-02-25. Interventions recorded: enfortumab vedotin and pembrolizumab. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04225117","url":"https://clinicaltrials.gov/study/NCT04225117"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["enfortumab-vedotin","pembrolizumab"],"companies":["astellas","pfizer","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04225117","phase":"2","setting":"An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)","sponsor":"Astellas Pharma Global Development, Inc.","started":"2020-03-10","startedType":"actual","yearReported":2026,"enrolled":329,"enrolledBasis":"registry","outcomes":[{"endpoint":"Cohorts 1-8: Confirmed Overall Response Rate (ORR) (Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V)1.1 Per Investigator Assessment","primary":true,"unit":"%","arms":[{"name":"Cohort 1: HR+/HER2- Breast Cancer","n":45,"value":15.6,"note":"95% CI 6.49 to 29.46; Figures from the ClinicalTrials.gov results section (first posted 2026-04-13), not from a publication"},{"name":"Cohort 2: TNBC Cancer","n":42,"value":19,"note":"95% CI 8.60 to 34.12"},{"name":"Cohort 3: Squamous NSCLC","n":23,"value":4.3,"note":"95% CI 0.11 to 21.95"},{"name":"Cohort 4: Non-squamous NSCLC","n":43,"value":16.3,"note":"95% CI 6.81 to 30.70"},{"name":"Cohort 5: Head and Neck Cancer","n":46,"value":23.9,"note":"95% CI 12.59 to 38.77"},{"name":"Cohort 7: EAC","n":42,"value":9.5,"note":"95% CI 2.66 to 22.62"},{"name":"Cohort 8: ESCC","n":44,"value":18.2,"note":"95% CI 8.19 to 32.71"}],"source":"https://clinicaltrials.gov/study/NCT04225117?tab=results"},{"endpoint":"Cohort 9: Confirmed ORR (CR and PR) Per RECIST V1.1 Per Investigator Assessment","primary":true,"unit":"%","arms":[{"name":"Cohort 9: HNSCC","n":41,"value":39,"note":"95% CI 24.20 to 55.50; Figures from the ClinicalTrials.gov results section (first posted 2026-04-13), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04225117?tab=results"}]},{"id":"nct07668752","kind":"trial","name":"A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation","aka":[],"tldr":"A phase 3 trial testing GFH375 in non-small-cell lung cancer, now recruiting.","summary":"A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation is a phase 3 interventional study registered as NCT07668752, led by Genfleet Therapeutics (Shanghai), and recruiting on the registry. Official title: A Phase III, Randomised, Open-Label, Multicenter Study to Evaluate GFH375 Versus Docetaxel in Participants With Locally Advanced and Unresectable or Metastatic Non-Small Cell Lung Cancer With KRAS G12D Mutation Failed Prior Standard Therapy. Planned enrolment is 300 participants (estimated). The study started in 2026-07-27 and primary completion is expected in 2030-06-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07668752","url":"https://clinicaltrials.gov/study/NCT07668752"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["gfh375"],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07668752","phase":"3","setting":"A Phase III, Randomized, Open-Label, Multicenter Study to Evaluate GFH375 Versus Docetaxel in Participants With Locally Advanced and Unresectable or Metastatic Non-Small Cell Lung Cancer With KRAS G12D Mutation Failed Prior Standard Therapy","sponsor":"Genfleet Therapeutics (Shanghai)","started":"2026-07-27","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06084936","kind":"trial","name":"A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma","aka":["GLOBRYTE"],"tldr":"A phase 3 trial of Obinutuzumab, Glofitamab, Rituximab, Bendamustine, Lenalidomide and Tocilizumab in non-Hodgkin lymphoma, run by Hoffmann-La Roche, now recruiting.","summary":"A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma is a phase 3 interventional study registered as NCT06084936 by Hoffmann-La Roche, with 182 participants planned, started 2023-10-22 and due to reach its primary completion in 2027-08-31. Interventions recorded: Obinutuzumab, Glofitamab, Rituximab, Bendamustine, Lenalidomide and Tocilizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06084936","url":"https://clinicaltrials.gov/study/NCT06084936"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","mantle-cell-lymphoma"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["obinutuzumab","glofitamab","rituximab","bendamustine","lenalidomide","tocilizumab"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06084936","phase":"3","setting":"A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed/Refractory Mantle Cell Lymphoma","sponsor":"Hoffmann-La Roche","started":"2023-10-22","startedType":"actual","enrolled":182,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05533775","kind":"trial","name":"A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Matu","aka":["iMATRIX GLO"],"tldr":"A phase 1/2 trial of Obinutuzumab, Glofitamab, Rituximab in hodgkin lymphoma and non-hodgkin lymphoma, run by Hoffmann-La Roche, now recruiting.","summary":"A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma is a phase 1/2 interventional study registered as NCT05533775 by Hoffmann-La Roche, with 65 participants planned, started 2022-11-16 and due to reach its primary completion in 2029-11-30. Interventions recorded: Obinutuzumab, Glofitamab, Rituximab, Ifosfamide, Carboplatin. Conditions listed: Mature B-Cell Non-Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05533775","url":"https://clinicaltrials.gov/study/NCT05533775"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["obinutuzumab","glofitamab","rituximab","ifosfamide","carboplatin","etoposide"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05533775","phase":"1/2","setting":"A Phase I/II, Open-Label, Single-Arm, Two-Part Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Glofitamab in Monotherapy and in Combination With Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma","sponsor":"Hoffmann-La Roche","started":"2022-11-16","startedType":"actual","enrolled":65,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07294508","kind":"trial","name":"A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer","aka":[],"tldr":"A phase 2/3 trial of Pertuzumab in HER2-positive breast cancer, run by Shanghai Henlius Biotech, now recruiting.","summary":"A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer is a phase 2/3 interventional study registered as NCT07294508 by Shanghai Henlius Biotech, with 706 participants planned, started 2026-02-27 and due to reach its primary completion in 2028-01-15. Interventions recorded: HLX87 + HLX22, HLX87 + Pertuzumab, T-Dxd + Pertuzumab and THP.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07294508","url":"https://clinicaltrials.gov/study/NCT07294508"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["pertuzumab"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07294508","phase":"2/3","setting":"An Open-Label, Randomized, Multicenter, Phase II/III Clinical Study to Evaluate HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With HLX87 (HER2 ADC) as First-Line Treatment in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer","sponsor":"Shanghai Henlius Biotech","started":"2026-02-27","startedType":"actual","enrolled":706,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06387069","kind":"trial","name":"A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia","aka":[],"tldr":"A phase 3 trial testing HMPL-306 in acute myeloid leukaemia, now recruiting.","summary":"A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukaemia is a phase 3 interventional study registered as NCT06387069, led by Hutchmed, and recruiting on the registry. Official title: A Multicenter, Randomised, Open-Label, Phase III Clinical Study to Evaluate the Efficacy and Safety of HMPL-306 vs. Salvage Chemotherapy Regimens in Patients With IDH1- and IDH2-mutated Relapsed/Refractory Acute Myeloid Leukaemia (R/R AML). Planned enrolment is 316 participants (estimated). The study started in 2024-04-26 and primary completion is expected in 2028-12-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06387069","url":"https://clinicaltrials.gov/study/NCT06387069"}],"tags":["ctgov-ingest"],"related":[],"cancers":["aml","aml-idh"],"sections":[],"technologies":[],"targets":[],"drugs":["hmpl-306"],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06387069","phase":"3","setting":"A Multicenter, Randomized, Open-Label, Phase III Clinical Study to Evaluate the Efficacy and Safety of HMPL-306 vs. Salvage Chemotherapy Regimens in Patients With IDH1- and IDH2-mutated Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)","sponsor":"Hutchmed","started":"2024-04-26","startedType":"actual","enrolled":316,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07823322","kind":"trial","name":"A Study to Evaluate INCA33890 in the Treatment of Circulating Tumor DNA-Positive Stage II/III Microsatellite Stable Colorectal Cancer After Curative Resection a","aka":["NEXERA-204"],"tldr":"A phase 2 trial of INCA33890 in colorectal cancer, run by Incyte Corporation, not yet recruiting.","summary":"A Study to Evaluate INCA33890 in the Treatment of Circulating Tumor DNA-Positive Stage II/III Microsatellite Stable Colorectal Cancer After Curative Resection and Chemotherapy is a phase 2, interventional study registered as NCT07823322 by Incyte Corporation, with a registry enrolment figure of 40 participants, started 2026-10-26 and due to reach its primary completion in 2029-05-14. Interventions recorded: INCA33890. Conditions listed: CRC (Colorectal Cancer). Primary outcome: Circulating tumor DNA (ctDNA) clearance. Colorectal eligibility wording from the registry: \"* Received curative-intent (R0) resection of histologically confirmed Stage II or III colorectal adenocarcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07823322","url":"https://clinicaltrials.gov/study/NCT07823322"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":["inca33890"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07823322","phase":"2","setting":"A Phase 2 Study of INCA33890 in the Treatment of Circulating Tumor DNA-Positive Stage II/III Microsatellite Stable Colorectal Cancer After Curative Resection and Chemotherapy (NEXERA-204)","sponsor":"Incyte Corporation","started":"2026-10-26","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05879822","kind":"trial","name":"A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive","aka":[],"tldr":"A phase 2 trial of INCB099280 in advanced solid tumours, run by Incyte Corporation, active and no longer recruiting.","summary":"A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive is a phase 2 interventional study registered as NCT05879822 by Incyte Corporation, with 73 participants enrolled, started 2023-10-30 and due to reach its primary completion in 2026-09-30. Interventions recorded: INCB099280.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05879822","url":"https://clinicaltrials.gov/study/NCT05879822"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05879822","phase":"2","setting":"A Phase 2 Study Evaluating INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive","sponsor":"Incyte Corporation","started":"2023-10-30","startedType":"actual","enrolled":73,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05319730","kind":"trial","name":"A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)","aka":["KEYMAKER-U06"],"tldr":"A phase 1/2 trial of Pembrolizumab, Lenvatinib, Sacituzumab tirumotecan and Dexamethasone in oesophageal cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B) is a phase 1/2 interventional study registered as NCT05319730 by Merck Sharp & Dohme LLC, with 230 participants planned, started 2023-05-16 and due to reach its primary completion in 2027-06-11. Interventions recorded: Paclitaxel, Irinotecan, Pembrolizumab, MK-4830, Lenvatinib and Sacituzumab tirumotecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05319730","url":"https://clinicaltrials.gov/study/NCT05319730"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","lenvatinib","sacituzumab-tirumotecan","dexamethasone"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05319730","phase":"1/2","setting":"A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B","sponsor":"Merck Sharp & Dohme LLC","started":"2023-05-16","startedType":"actual","enrolled":230,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06468358","kind":"trial","name":"A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors","aka":["TRIGGERCD8"],"tldr":"A phase 1/2 trial of LB1410 and LB4330 in advanced solid tumours, run by L & L Bio Co., Ltd., Ningbo, China, now recruiting.","summary":"A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06468358 by L & L Bio Co., Ltd., Ningbo, China, with 194 participants planned, started 2024-06-19 and due to reach its primary completion in 2026-12-30. Interventions recorded: LB1410 and LB4330.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06468358","url":"https://clinicaltrials.gov/study/NCT06468358"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["lb1410","lb4330"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06468358","phase":"1/2","setting":"A Phase Ib/II, Open, Dose-escalation and Expansion Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors","sponsor":"L & L Bio Co., Ltd., Ningbo, China","started":"2024-06-19","startedType":"actual","enrolled":194,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06319963","kind":"trial","name":"A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer","aka":[],"tldr":"A phase 1/2 trial of Two IM injections Lenti-HPV-07 in cervical cancer and head and neck squamous cell carcinoma, run by Theravectys S.A., now recruiting.","summary":"A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer is a phase 1/2 interventional study registered as NCT06319963 by Theravectys S.A., with 72 participants planned, started 2024-08-08 and due to reach its primary completion in 2026-06. Interventions recorded: Two IM injections Lenti-HPV-07 and One IM injection Lenti-HPV-07.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06319963","url":"https://clinicaltrials.gov/study/NCT06319963"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cervical","head-and-neck","oropharyngeal-cancer","hpv-positive-oropharyngeal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06319963","phase":"1/2","setting":"An Open-Label Phase 1/2a Clinical Trial to Evaluate the Safety, Immunogenicity, and Preliminary Efficacy of a Lentiviral Vector-Based Therapeutic Vaccine Against Human Papilloma Virus (Lenti-HPV-07) in Participants With HPV-Associated Oropharyngeal Squamous Cell Cancer or Cervical Cancer","sponsor":"Theravectys S.A.","started":"2024-08-08","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04064060","kind":"trial","name":"A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials","aka":[],"tldr":"A phase 3 trial of Luspatercept in myelodysplastic syndromes / neoplasms and myeloproliferative neoplasms, run by Celgene, now recruiting.","summary":"A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials is a phase 3 interventional study registered as NCT04064060 by Celgene, with 665 participants planned, started 2019-08-12 and due to reach its primary completion in 2028-05-12. Interventions recorded: Luspatercept.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04064060","url":"https://clinicaltrials.gov/study/NCT04064060"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mds","myeloproliferative-neoplasms"],"sections":[],"technologies":["transfusion-support"],"targets":[],"drugs":["luspatercept"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04064060","phase":"3","setting":"A Phase 3b, Open-label, Single-arm, Rollover Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials","sponsor":"Celgene","started":"2019-08-12","startedType":"actual","enrolled":665,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04170283","kind":"trial","name":"A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib","aka":[],"tldr":"A phase 3 trial of Zanubrutinib and Tislelizumab in advanced solid tumours, run by BeOne Medicines, active and no longer recruiting.","summary":"A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib is a phase 3 interventional study registered as NCT04170283 by BeOne Medicines, with 955 participants enrolled, started 2020-01-16 and due to reach its primary completion in 2026-12-31. Interventions recorded: Zanubrutinib and Tislelizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04170283","url":"https://clinicaltrials.gov/study/NCT04170283"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["zanubrutinib","tislelizumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04170283","phase":"3","setting":"An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies","sponsor":"BeOne Medicines","started":"2020-01-16","startedType":"actual","enrolled":955,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07169851","kind":"trial","name":"A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer","aka":[],"tldr":"A phase 2 trial of LY3537021 in advanced solid tumours, run by Eli Lilly and Company, now recruiting.","summary":"A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer is a phase 2 interventional study registered as NCT07169851 by Eli Lilly and Company, with 204 participants planned, started 2025-11-28 and due to reach its primary completion in 2026-12. Interventions recorded: LY3537021, Placebo, Standard of Care Antiemetic Therapies and Background Chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07169851","url":"https://clinicaltrials.gov/study/NCT07169851"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07169851","phase":"2","setting":"A Phase 2, Double-blind, Placebo-Controlled Study to Evaluate LY3537021 for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Adult Participants With Malignant Disease","sponsor":"Eli Lilly and Company","started":"2025-11-28","startedType":"actual","enrolled":204,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05552976","kind":"trial","name":"A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants W","aka":["SUCCESSOR-2"],"tldr":"A phase 3 trial of Mezigdomide, Carfilzomib, Dexamethasone in multiple myeloma, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2) is a phase 3 interventional study registered as NCT05552976 by Bristol-Myers Squibb, with 606 participants enrolled, started 2023-01-10 and due to reach its primary completion in 2026-07-18. Interventions recorded: Mezigdomide, Carfilzomib, Dexamethasone. Conditions listed: Relapsed or Refractory Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05552976","url":"https://clinicaltrials.gov/study/NCT05552976"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","celmods","protac-degrader"],"targets":[],"drugs":["mezigdomide","carfilzomib","dexamethasone"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05552976","phase":"3","setting":"A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-2","sponsor":"Bristol-Myers Squibb","started":"2023-01-10","startedType":"actual","enrolled":606,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05519085","kind":"trial","name":"A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Re","aka":["SUCCESSOR-1"],"tldr":"A phase 3 trial of Mezigdomide, Pomalidomide, Bortezomib in multiple myeloma, run by Celgene, now recruiting.","summary":"A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) is a phase 3 interventional study registered as NCT05519085 by Celgene, with 810 participants planned, started 2022-09-20 and due to reach its primary completion in 2027-01-10. Interventions recorded: mezigdomide, Pomalidomide, Bortezomib, Dexamethasone. Conditions listed: Relapsed or Refractory Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05519085","url":"https://clinicaltrials.gov/study/NCT05519085"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","celmods","kinase-inhibitors","protac-degrader"],"targets":[],"drugs":["mezigdomide","pomalidomide","bortezomib","dexamethasone"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05519085","phase":"3","setting":"A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1","sponsor":"Celgene","started":"2022-09-20","startedType":"actual","enrolled":810,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05751512","kind":"trial","name":"A Study to Evaluate MRG003 vs Cetuximab/Methotrexate in in the Treatment of Patients With RM-SCCHN","aka":[],"tldr":"A phase 3 trial testing MRG003 in head and neck squamous cell carcinoma, now recruiting.","summary":"A Study to Evaluate MRG003 vs Cetuximab/Methotrexate in in the Treatment of Patients With RM-SCCHN is a phase 3 interventional study registered as NCT05751512, led by Lepu Biopharma, and recruiting on the registry. Official title: A Randomised, Open-Label, Multicenter, Phase III Study to Evaluate MRG003 vs Cetuximab/Methotrexate as Second/Third Line of Treatment in Patient With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (RM-SCCHN). Planned enrolment is 180 participants (estimated). The study started in 2023-04-04 and primary completion is expected in 2027-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05751512","url":"https://clinicaltrials.gov/study/NCT05751512"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["mrg003"],"companies":["lepu-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05751512","phase":"3","setting":"A Randomized, Open-Label, Multicenter, Phase III Study to Evaluate MRG003 vs Cetuximab/Methotrexate as Second/Third Line of Treatment in Patient With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (RM-SCCHN)","sponsor":"Lepu Biopharma","started":"2023-04-04","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06500884","kind":"trial","name":"A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events","aka":["Talisman"],"tldr":"A phase 2 trial of Talquetamab in multiple myeloma, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events is a phase 2 interventional study registered as NCT06500884 by Janssen Research & Development, LLC, with 210 participants planned, started 2024-08-26 and due to reach its primary completion in 2030-05-30. Interventions recorded: Talquetamab, Prophylaxis A, Prophylaxis B, Prophylaxis C, Prophylaxis D. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06500884","url":"https://clinicaltrials.gov/study/NCT06500884"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["talquetamab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06500884","phase":"2","setting":"A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events","sponsor":"Janssen Research & Development, LLC","started":"2024-08-26","startedType":"actual","enrolled":210,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07361497","kind":"trial","name":"A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell","aka":["ROSETTA Lung-201"],"tldr":"A phase 3 trial of PM8002, Durvalumab in non-small-cell lung cancer and small-cell lung cancer, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201) is a phase 3 interventional study registered as NCT07361497 by Bristol-Myers Squibb, with 850 participants planned, started 2026-03-16 and due to reach its primary completion in 2030-09-18. Interventions recorded: Pumitamig, Durvalumab. Conditions listed: Non-small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07361497","url":"https://clinicaltrials.gov/study/NCT07361497"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pm8002","durvalumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07361497","phase":"3","setting":"ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants With Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy.","sponsor":"Bristol-Myers Squibb","started":"2026-03-16","startedType":"actual","enrolled":850,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06356311","kind":"trial","name":"A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)","aka":["TroFuse-015"],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, FOLFIRI, Paclitaxel / nab-paclitaxel in oesophageal cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015) is a phase 3 interventional study registered as NCT06356311 by Merck Sharp & Dohme LLC, with 450 participants planned, started 2024-05-03 and due to reach its primary completion in 2027-01-04. Interventions recorded: Sacituzumab tirumotecan, Trifluridine-Tipiracil, Irinotecan, Paclitaxel, Docetaxel. Conditions listed: Gastroesophageal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06356311","url":"https://clinicaltrials.gov/study/NCT06356311"}],"tags":["ctgov-ingest"],"related":[],"cancers":["esophageal","oesophageal-adenocarcinoma"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","folfiri","paclitaxel","docetaxel"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06356311","phase":"3","setting":"A Phase 3, Multicenter, Open-label, Randomized Study to Compare the Efficacy and Safety of MK-2870 Versus Treatment of Physician's Choice in 3L+ Advanced/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma)","sponsor":"Merck Sharp & Dohme LLC","started":"2024-05-03","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05053880","kind":"trial","name":"A Study to Evaluate Safety and Efficacy of ACT001 and Anti-PD-1 in Patients With Surgically Accessible Recurrent Glioblastoma Multiforme","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in glioma & glioblastoma, run by Accendatech USA Inc., active and no longer recruiting.","summary":"A Study to Evaluate Safety and Efficacy of ACT001 and Anti-PD-1 in Patients With Surgically Accessible Recurrent Glioblastoma Multiforme is a phase 1/2 interventional study registered as NCT05053880 by Accendatech USA Inc., with 48 participants enrolled, started 2021-09-22 and due to reach its primary completion in 2024-10-25. Interventions recorded: ACT001 and ACT001 + Pembrolizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05053880","url":"https://clinicaltrials.gov/study/NCT05053880"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05053880","phase":"1/2","setting":"A Phase 1b/2a Study of ACT001 and Anti-PD-1 in Patients With Surgically Accessible Recurrent Glioblastoma Multiforme","sponsor":"Accendatech USA Inc.","started":"2021-09-22","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05093907","kind":"trial","name":"A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of Capecitabine in colorectal cancer, run by BeyondBio Inc., now recruiting.","summary":"A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer is a phase 1/2 interventional study registered as NCT05093907 by BeyondBio Inc., with 27 participants planned, started 2021-08-31 and due to reach its primary completion in 2026-11-30. Interventions recorded: BEY1107, Capecitabine. Conditions listed: Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05093907","url":"https://clinicaltrials.gov/study/NCT05093907"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05093907","phase":"1/2","setting":"An Open-label, Single Center, Phase I/II Clinical Trial to Assess the Maximum Tolerated Dose, Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer Refractory or Intolerant to Standard of Care","sponsor":"BeyondBio Inc.","started":"2021-08-31","startedType":"actual","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06351631","kind":"trial","name":"A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)","aka":[],"tldr":"A phase 3 trial testing Bomedemstat in myeloproliferative neoplasms, now recruiting.","summary":"A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017) is a phase 3 interventional study registered as NCT06351631, led by Merck Sharp & Dohme, and recruiting on the registry. Official title: A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study. Planned enrolment is 400 participants (estimated). The study started in 2024-05-23 and primary completion is expected in 2034-12-04. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06351631","url":"https://clinicaltrials.gov/study/NCT06351631"}],"tags":["ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms"],"sections":[],"technologies":["lsd1-inhibitors"],"targets":[],"drugs":["bomedemstat"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06351631","phase":"3","setting":"A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study","sponsor":"Merck Sharp & Dohme","started":"2024-05-23","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07206498","kind":"trial","name":"A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC","aka":["WAYWIN103"],"tldr":"A phase 1/2 trial of Osimertinib in non-small-cell lung cancer and small-cell lung cancer, run by Wayshine Biopharm, Inc., now recruiting.","summary":"A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC is a phase 1/2 interventional study registered as NCT07206498 by Wayshine Biopharm, Inc., with 48 participants planned, started 2025-10-17 and due to reach its primary completion in 2028-10-14. Interventions recorded: Osimertinib (Tagrisso®), WSD0922-FU. Conditions listed: Non Small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07206498","url":"https://clinicaltrials.gov/study/NCT07206498"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":["wayshine-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07206498","phase":"1/2","setting":"A Phase I/II Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU in Combination With Osimertinib for Patients With Locally Advanced or Metastatic Non- Small Cell Lung Cancer","sponsor":"Wayshine Biopharm, Inc.","started":"2025-10-17","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05372354","kind":"trial","name":"A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed ","aka":[],"tldr":"A phase 1/2 trial of Mezigdomide, Tazemetostat, Trametinib in multiple myeloma, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT05372354 by Bristol-Myers Squibb, with 260 participants planned, started 2022-10-18 and due to reach its primary completion in 2026-10-12. Interventions recorded: CC-92480, Tazemetostat, BMS-986158, Trametinib, Dexamethasone. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05372354","url":"https://clinicaltrials.gov/study/NCT05372354"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["celmods","protac-degrader"],"targets":[],"drugs":["mezigdomide","tazemetostat","trametinib","dexamethasone"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05372354","phase":"1/2","setting":"An Exploratory Phase 1b/2a Multicenter, Open-Label, Novel-Novel Combination Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CC-92480 (BMS-986348) in Novel Therapeutic Combinations in Participants With Relapsed or Refractory Multiple Myeloma","sponsor":"Bristol-Myers Squibb","started":"2022-10-18","startedType":"actual","enrolled":260,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05318573","kind":"trial","name":"A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Fujifilm Pharmaceuticals U.S.A., Inc., active and no longer recruiting.","summary":"A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT05318573 by Fujifilm Pharmaceuticals U.S.A., Inc., with 120 participants planned, started 2022-06-01 and due to reach its primary completion in 2029-05. Interventions recorded: Pembrolizumab, FF-10832. Conditions listed: Advanced Urothelial Carcinoma, Advanced Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05318573","url":"https://clinicaltrials.gov/study/NCT05318573"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["fujifilm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05318573","phase":"2","setting":"A Phase 2a Study With Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Tumors","sponsor":"Fujifilm Pharmaceuticals U.S.A., Inc.","started":"2022-06-01","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06542250","kind":"trial","name":"A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies.","aka":["TITANium"],"tldr":"A phase 1/2 trial of AZD5492 in advanced solid tumours, run by AstraZeneca, now recruiting.","summary":"A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies. is a phase 1/2 interventional study registered as NCT06542250 by AstraZeneca, with 174 participants planned, started 2024-09-18 and due to reach its primary completion in 2029-12-18. Interventions recorded: AZD5492.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06542250","url":"https://clinicaltrials.gov/study/NCT06542250"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["azd5492"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06542250","phase":"1/2","setting":"A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With Relapsed or Refractory B-Cell Malignancies (TITANium)","sponsor":"AstraZeneca","started":"2024-09-18","startedType":"actual","enrolled":174,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06522828","kind":"trial","name":"A Study to Evaluate SSGJ-707 in Advanced Gynecologic Cancer Patients","aka":[],"tldr":"A phase 2 trial of PF-08634404, Carboplatin, Paclitaxel / nab-paclitaxel in endometrial cancer and ovarian cancer, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., now recruiting.","summary":"A Study to Evaluate SSGJ-707 in Advanced Gynecologic Cancer Patients is a phase 2 interventional study registered as NCT06522828 by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., with 80 participants planned, started 2024-10-10 and due to reach its primary completion in 2025-08. Interventions recorded: SSGJ-707, carboplatin, paclitaxel. Conditions listed: Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06522828","url":"https://clinicaltrials.gov/study/NCT06522828"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial","ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-08634404","carboplatin","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06522828","phase":"2","setting":"A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 in Advanced Gynecologic Cancer Patients","sponsor":"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.","started":"2024-10-10","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06055959","kind":"trial","name":"A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis","aka":[],"tldr":"A phase 2/3 trial of Zilucoplan in childhood cancers, run by UCB Biopharma SRL, now recruiting.","summary":"A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis is a phase 2/3 interventional study registered as NCT06055959 by UCB Biopharma SRL, with 8 participants planned, started 2024-10-16 and due to reach its primary completion in 2026-11-16. Interventions recorded: Zilucoplan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06055959","url":"https://clinicaltrials.gov/study/NCT06055959"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["childhood-cancers"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ucb"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06055959","phase":"2/3","setting":"A Multicenter Open-Label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Activity of Zilucoplan in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis","sponsor":"UCB Biopharma SRL","started":"2024-10-16","startedType":"actual","enrolled":8,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04554914","kind":"trial","name":"A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases","aka":["EBVision"],"tldr":"A phase 2 trial of Tabelecleucel in brain and spinal cord tumours, sarcomas and uterine sarcoma, run by Pierre Fabre Medicament, active and no longer recruiting.","summary":"A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases is a phase 2 interventional study registered as NCT04554914 by Pierre Fabre Medicament, with 190 participants enrolled, started 2021-07-14 and due to reach its primary completion in 2027-06. Interventions recorded: Tabelecleucel.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04554914","url":"https://clinicaltrials.gov/study/NCT04554914"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["brain-tumours","sarcoma","uterine-sarcoma"],"sections":[],"technologies":["virus-specific-t-cells"],"targets":[],"drugs":["tabelecleucel"],"companies":["pierre-fabre"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04554914","phase":"2","setting":"An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects With Epstein Barr Virus Associated Diseases (EBVision)","sponsor":"Pierre Fabre Medicament","started":"2021-07-14","startedType":"actual","enrolled":190,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06919965","kind":"trial","name":"A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer","aka":["MoonRISe-3"],"tldr":"A phase 3 trial testing TAR-210 in bladder & urothelial cancer, now recruiting.","summary":"A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer is a phase 3 interventional study registered as NCT06919965, led by Janssen Research & Development, and recruiting on the registry. Official title: A Phase 3, Randomised, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG). Planned enrolment is 220 participants (estimated). The study started in 2025-09-10 and primary completion is expected in 2028-04-06. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06919965","url":"https://clinicaltrials.gov/study/NCT06919965"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tar-210"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06919965","phase":"3","setting":"A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)","sponsor":"Janssen Research & Development","started":"2025-09-10","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06319820","kind":"trial","name":"A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer","aka":["MoonRISe-1"],"tldr":"A phase 3 trial of TAR-210 and Gemcitabine in bladder & urothelial cancer, run by Janssen Research & Development, LLC, now recruiting.","summary":"A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer is a phase 3 interventional study registered as NCT06319820 by Janssen Research & Development, LLC, with 641 participants planned, started 2024-04-18 and due to reach its primary completion in 2028-06-28. Interventions recorded: TAR-210, Gemcitabine and MMC.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06319820","url":"https://clinicaltrials.gov/study/NCT06319820"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tar-210","gemcitabine"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06319820","phase":"3","setting":"A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations","sponsor":"Janssen Research & Development, LLC","started":"2024-04-18","startedType":"actual","enrolled":641,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06820463","kind":"trial","name":"A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil,","aka":["AndroMETa-CRC"],"tldr":"A phase 2 trial of Telisotuzumab adizutecan, Fluorouracil, CAPOX in colorectal cancer, run by AbbVie, now recruiting.","summary":"A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer is a phase 2 interventional study registered as NCT06820463 by AbbVie, with 390 participants planned, started 2025-04-24 and due to reach its primary completion in 2028-03. Interventions recorded: Telisotuzumab Adizutecan, Fluorouracil, Oxaliplatin, Leucovorin, Bevacizumab. Conditions listed: Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06820463","url":"https://clinicaltrials.gov/study/NCT06820463"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["telisotuzumab-adizutecan","fluorouracil","capox","flot","bevacizumab","panitumumab"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06820463","phase":"2","setting":"A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer","sponsor":"AbbVie","started":"2025-04-24","startedType":"actual","enrolled":390,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06284317","kind":"trial","name":"A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Canc","aka":["ADOPT-lung"],"tldr":"A phase 3 trial in lung cancer, run by ETOP IBCSG Partners Foundation, now recruiting.","summary":"A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer. is a phase 3, randomised interventional study registered as NCT06284317 by ETOP IBCSG Partners Foundation, with a registry enrolment figure of 290 participants, started 2025-01-15 and due to reach its primary completion in 2029-10. Interventions recorded: Adjuvant durvalumab. Conditions listed: Non Small Cell Lung Cancer. Primary outcome: Disease-free survival (DFS). Lung eligibility wording from the registry: \"* Histologically confirmed NSCLC\". Sites: Australia, Austria, Belgium, Estonia, France, Ireland, Italy, Netherlands, Switzerland, United Kingdom. United Kingdom sites listed: 5. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06284317","url":"https://clinicaltrials.gov/study/NCT06284317"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Barts Health NHS Trust (London); Royal Marsden Hospital (Chelsea) (London); Royal Marsden Hospital (Sutton) (London); Maidstone and Tunbridge Wells NHS Trust (Maidstone); Wythenshawe Hospital, Manchester University NHS Foundation Trust (Manchester)."],"nct":"NCT06284317","phase":"3","setting":"An International, Multicentre, Open-label Randomised Phase III Trial to Evaluate the Benefit of Adding Adjuvant Durvalumab After Neoadjuvant Chemotherapy Plus Durvalumab in Patients With Stage IIB-IIIB (N2) Resectable NSCLC","sponsor":"ETOP IBCSG Partners Foundation","started":"2025-01-15","startedType":"actual","enrolled":290,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07100106","kind":"trial","name":"A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer","aka":["MoonROSE"],"tldr":"A phase 1/2 trial of Giredestrant and Abemaciclib in HR-positive / HER2-negative breast cancer, run by Genentech, Inc., now recruiting.","summary":"A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer is a phase 1/2 interventional study registered as NCT07100106 by Genentech, Inc., with 285 participants planned, started 2025-10-07 and due to reach its primary completion in 2028-08-31. Interventions recorded: GDC-4198, Giredestrant and Abemaciclib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07100106","url":"https://clinicaltrials.gov/study/NCT07100106"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy"],"targets":[],"drugs":["giredestrant","abemaciclib"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07100106","phase":"1/2","setting":"A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4/6 Inhibitor","sponsor":"Genentech, Inc.","started":"2025-10-07","startedType":"actual","enrolled":285,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06524375","kind":"trial","name":"A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-treatment Period","aka":["BRAVE"],"tldr":"A phase 2 trial of Venetoclax in chronic lymphocytic leukaemia, run by Genentech, Inc., active and no longer recruiting.","summary":"A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-treatment Period is a phase 2 interventional study registered as NCT06524375 by Genentech, Inc., with 118 participants enrolled, started 2024-08-09 and due to reach its primary completion in 2026-10-31. Interventions recorded: Venetoclax and cBTKi Monotherapy.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06524375","url":"https://clinicaltrials.gov/study/NCT06524375"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["venetoclax"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06524375","phase":"2","setting":"Phase II, Open-label, Prospective Single-arm, Multi-center Clinical Trial to Evaluate if Adding Venetoclax to Patients on Covalent BTKi For 1L CLL Can Achieve Deep Durable Remissions (by UMRD 10^-4) to Allow Off-treatment Period","sponsor":"Genentech, Inc.","started":"2024-08-09","startedType":"actual","enrolled":118,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07409272","kind":"trial","name":"A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial testing Setidegrasib in pancreatic ductal adenocarcinoma, now recruiting.","summary":"A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer is a phase 3 interventional study registered as NCT07409272, led by Astellas Pharma Global Development, and recruiting on the registry. Official title: A Phase 3, Double-blind, Placebo-controlled, Randomised Study to Assess the Efficacy and Safety of ASP3082 in Combination With mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants With KRAS G12D Mutated Metastatic Pancreatic Adenocarcinoma. Planned enrolment is 614 participants (estimated). The study started in 2026-02-17 and primary completion is expected in 2029-08-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07409272","url":"https://clinicaltrials.gov/study/NCT07409272"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["setidegrasib"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07409272","phase":"3","setting":"A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination With mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants With KRAS G12D Mutated Metastatic Pancreatic Adenocarcinoma","sponsor":"Astellas Pharma Global Development","started":"2026-02-17","startedType":"actual","enrolled":614,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07227311","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Mult","aka":["DREAMM-15"],"tldr":"A phase 2 trial of Belantamab mafodotin, Dexamethasone, Pomalidomide in multiple myeloma, run by GlaxoSmithKline, now recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM) is a phase 2 interventional study registered as NCT07227311 by GlaxoSmithKline, with 200 participants planned, started 2026-04-15 and due to reach its primary completion in 2030-08-30. Interventions recorded: Belantamab mafodotin, Dexamethasone, Pomalidomide, Bortezomib, Carfilzomib. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07227311","url":"https://clinicaltrials.gov/study/NCT07227311"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["belantamab-mafodotin","dexamethasone","pomalidomide","bortezomib","carfilzomib"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07227311","phase":"2","setting":"A Phase 2, Multicenter, Open Label, Non-randomized Study to Evaluate the Efficacy and Safety of Extended Dosing of Belantamab Mafodotin in Different Combinations With Standard of Care Regimens in Participants With Relapsed-refractory Multiple Myeloma (DREAMM-15)","sponsor":"GlaxoSmithKline","started":"2026-04-15","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05043922","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma","aka":[],"tldr":"A phase 2 trial of CYH33 in ovarian cancer, run by Haihe Biopharma Co., Ltd., active and no longer recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma is a phase 2 interventional study registered as NCT05043922 by Haihe Biopharma Co., Ltd., with 93 participants enrolled, started 2021-10-11 and due to reach its primary completion in 2024-07-31. Interventions recorded: CYH33.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05043922","url":"https://clinicaltrials.gov/study/NCT05043922"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","clear-cell-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cyh33"],"companies":["haihe-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05043922","phase":"2","setting":"A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of CYH33, a Selective PI3Kα Inhibitor in Patients With Recurrent/Persistent Ovary, Fallopian Tube or Primary Peritoneal Clear Cell Carcinoma","sponsor":"Haihe Biopharma Co., Ltd.","started":"2021-10-11","startedType":"actual","enrolled":93,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07541170","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Rese","aka":["KRASCENDO 3"],"tldr":"A phase 3 trial of Divarasib, Pembrolizumab, Nivolumab in non-small-cell lung cancer and small-cell lung cancer, run by Hoffmann-La Roche, now recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC) is a phase 3 interventional study registered as NCT07541170 by Hoffmann-La Roche, with 400 participants planned, started 2026-09-30 and due to reach its primary completion in 2032-01-31. Interventions recorded: Divarasib, Pembrolizumab, Nivolumab. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07541170","url":"https://clinicaltrials.gov/study/NCT07541170"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","kras-g12c-nsclc","resectable-nsclc"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["divarasib","pembrolizumab","nivolumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07541170","phase":"3","setting":"A Phase III, Randomized, Open-label Study Evaluating the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Patients With Resected Stage II-III KRAS G12C-Positive Non-small Cell Lung Cancer","sponsor":"Hoffmann-La Roche","started":"2026-09-30","startedType":"estimated","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05296798","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)","aka":[],"tldr":"A phase 3 trial of Giredestrant and Docetaxel in advanced solid tumours, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) is a phase 3 interventional study registered as NCT05296798 by Hoffmann-La Roche, with 922 participants enrolled, started 2022-07-18 and due to reach its primary completion in 2027-10-31. Interventions recorded: Phesgo, Giredestrant, Docetaxel, Paclitaxel, LHRH Agonist and Optional Endocrine Therapy of Investigator's Choice.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05296798","url":"https://clinicaltrials.gov/study/NCT05296798"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["giredestrant","docetaxel"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05296798","phase":"3","setting":"A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo + Taxane in Patients With Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast Cancer","sponsor":"Hoffmann-La Roche","started":"2022-07-18","startedType":"actual","enrolled":922,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06829459","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in N","aka":[],"tldr":"A phase 3 trial of Glumetinib run by Shanghai JMT-Bio Inc. in non-small-cell lung cancer and small-cell lung cancer, now recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients After Resistance to EGFR-TKIs is a phase 3 interventional study registered as NCT06829459 by Shanghai JMT-Bio Inc., with 350 participants planned, started 2025-04-03. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06829459","url":"https://clinicaltrials.gov/study/NCT06829459"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["glumetinib"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06829459","phase":"3","setting":"A Randomized, Controlled, Open-label Phase III Clinical Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients With MET Amplification and/or Overexpression After Resistance to EGFR-TKIs","sponsor":"Shanghai JMT-Bio Inc.","started":"2025-04-03","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06425302","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma","aka":["GOLSEEK-2"],"tldr":"A phase 2 trial of Golcadomide, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone in non-Hodgkin lymphoma, run by Celgene, active and no longer recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma is a phase 2 interventional study registered as NCT06425302 by Celgene, with 95 participants enrolled, started 2024-08-30 and due to reach its primary completion in 2026-06-19. Interventions recorded: Golcadomide, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06425302","url":"https://clinicaltrials.gov/study/NCT06425302"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","follicular-lymphoma"],"sections":[],"technologies":["monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["golcadomide","rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06425302","phase":"2","setting":"A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma","sponsor":"Celgene","started":"2024-08-30","startedType":"actual","enrolled":95,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05346224","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer","aka":[],"tldr":"A phase 3 trial testing HLX11 in HR-positive / HER2-negative breast cancer and HER2-positive breast cancer, active and no longer recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer is a phase 3 interventional study registered as NCT05346224, led by Shanghai Henlius Biotech, and active but no longer recruiting on the registry. Official title: A Multicenter, Randomised, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer. Planned enrolment is 900 participants (estimated). The study started in 2022-04-25 and primary completion is expected in 2024-05-15. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05346224","url":"https://clinicaltrials.gov/study/NCT05346224"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["hlx11"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05346224","phase":"3","setting":"A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer","sponsor":"Shanghai Henlius Biotech","started":"2022-04-25","startedType":"actual","enrolled":900,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07490262","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment","aka":[],"tldr":"A phase 2/3 trial testing IBI310 in hepatocellular carcinoma, now recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment is a phase 2/3 interventional study registered as NCT07490262, led by Innovent Biopharmaceutical Technology (Hangzhou), and recruiting on the registry. Official title: A Randomised, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy as First-line Treatment in Previously Untreated Patients With Unresectable or Metastatic Hepatocellular Carcinoma. Planned enrolment is 680 participants (estimated). The study started in 2026-03-27 and primary completion is expected in 2027-12-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07490262","url":"https://clinicaltrials.gov/study/NCT07490262"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":["ibi310"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07490262","phase":"2/3","setting":"A Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy as First-line Treatment in Previously Untreated Patients With Unresectable or Metastatic Hepatocellular Carcinoma","sponsor":"Innovent Biopharmaceutical Technology (Hangzhou)","started":"2026-03-27","startedType":"actual","enrolled":680,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06797297","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastat","aka":[],"tldr":"A phase 2 trial of IBI363, Pembrolizumab in melanoma, run by Innovent Biologics (Suzhou) Co. Ltd., now recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy is a phase 2 interventional study registered as NCT06797297 by Innovent Biologics (Suzhou) Co. Ltd., with 180 participants planned, started 2025-02-24 and due to reach its primary completion in 2026-03-31. Interventions recorded: IBI363, Pembrolizumab. Conditions listed: Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06797297","url":"https://clinicaltrials.gov/study/NCT06797297"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","acral-melanoma","advanced-melanoma","mucosal-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ibi363","pembrolizumab"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06797297","phase":"2","setting":"A Phase II, Open-label, Randomized, Multi-center Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal and Acral Melanoma Who Had Not Previously Received Systemic Therapy","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","started":"2025-02-24","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07082686","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)","aka":["APEX-06"],"tldr":"A phase 2 trial of ICP-248 in mantle cell lymphoma, run by Beijing InnoCare Pharma Tech Co., Ltd., now recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06) is a phase 2 interventional study registered as NCT07082686 by Beijing InnoCare Pharma Tech Co., Ltd., with 75 participants planned, started 2025-08-21 and due to reach its primary completion in 2027-12. Interventions recorded: ICP-248. Conditions listed: Relapsed or Refractory Mantle Cell Lymphoma (MCL). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07082686","url":"https://clinicaltrials.gov/study/NCT07082686"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["icp-248"],"companies":["innocare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07082686","phase":"2","setting":"A Single-arm, Multi-center, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","started":"2025-08-21","startedType":"actual","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06330064","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)","aka":["IDeate-PanTumor02"],"tldr":"A phase 1/2 trial of Ifinatamab deruxtecan in advanced solid tumours, run by Daiichi Sankyo, now recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02) is a phase 1/2 interventional study registered as NCT06330064 by Daiichi Sankyo, with 680 participants planned, started 2024-04-10 and due to reach its primary completion in 2028-07-25. Interventions recorded: Ifinatamab deruxtecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06330064","url":"https://clinicaltrials.gov/study/NCT06330064"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["ifinatamab-deruxtecan"],"companies":["daiichi-sankyo","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06330064","phase":"1/2","setting":"A Phase 1B/2 Pan-Tumor, Open-Label Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)","sponsor":"Daiichi Sankyo","started":"2024-04-10","startedType":"actual","enrolled":680,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05894239","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","aka":["INAVO122"],"tldr":"A phase 3 trial of Inavolisib in HER2-positive breast cancer, run by Hoffmann-La Roche, now recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer is a phase 3 interventional study registered as NCT05894239 by Hoffmann-La Roche, with 230 participants planned, started 2023-09-08 and due to reach its primary completion in 2026-12-31. Interventions recorded: Inavolisib, Phesgo, Placebo, Taxane-based Chemotherapy and Optional Endocrine Therapy of Investigator's Choice.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05894239","url":"https://clinicaltrials.gov/study/NCT05894239"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["inavolisib"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05894239","phase":"3","setting":"A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","sponsor":"Hoffmann-La Roche","started":"2023-09-08","startedType":"actual","enrolled":230,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04245839","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)","aka":["TRANSCEND FL"],"tldr":"A phase 2 trial of Fludarabine, Cyclophosphamide in non-hodgkin lymphoma, run by Celgene, active and no longer recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) is a phase 2 interventional study registered as NCT04245839 by Celgene, with 276 participants planned, started 2020-07-14 and due to reach its primary completion in 2031-09-30. Interventions recorded: Fludarabine, Cyclophosphamide, JCAR017. Conditions listed: Lymphoma, Non-Hodgkin. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04245839","url":"https://clinicaltrials.gov/study/NCT04245839"}],"tags":["ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["fludarabine","cyclophosphamide"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04245839","phase":"2","setting":"A Phase 2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)","sponsor":"Celgene","started":"2020-07-14","startedType":"actual","enrolled":276,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05126719","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma","aka":[],"tldr":"A phase 2 trial of MRG003, Capecitabine, Docetaxel in nasopharyngeal carcinoma, run by Lepu Biopharma Co., Ltd., active and no longer recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma is a phase 2 interventional study registered as NCT05126719 by Lepu Biopharma Co., Ltd., with 238 participants planned, started 2023-04-06 and due to reach its primary completion in 2024-12-30. Interventions recorded: MRG003, Capecitabine tablets, Docetaxel injection. Conditions listed: Recurrent or Metastatic Nasopharyngeal Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05126719","url":"https://clinicaltrials.gov/study/NCT05126719"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nasopharyngeal","recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["mrg003","capecitabine","docetaxel"],"companies":["lepu-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05126719","phase":"2","setting":"An Open-Label, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma","sponsor":"Lepu Biopharma Co., Ltd.","started":"2023-04-06","startedType":"actual","enrolled":238,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03178552","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)","aka":["B-FAST"],"tldr":"A phase 2/3 trial of Alectinib, Atezolizumab, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) is a phase 2/3 interventional study registered as NCT03178552 by Hoffmann-La Roche, with 1000 participants planned, started 2017-09-22 and due to reach its primary completion in 2027-06-30. Interventions recorded: Alectinib, Atezolizumab, Pemetrexed, Cisplatin, Carboplatin. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03178552","url":"https://clinicaltrials.gov/study/NCT03178552"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["alectinib","atezolizumab","pemetrexed","cisplatin","carboplatin","gemcitabine"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03178552-nat-med-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03178552","phase":"2/3","setting":"A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)","sponsor":"Hoffmann-La Roche","started":"2017-09-22","startedType":"actual","enrolled":1000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03671044","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients","aka":[],"tldr":"A phase 3 trial of Docetaxel in triple-negative breast cancer, run by Jina Pharmaceuticals Inc., now recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients is a phase 3 interventional study registered as NCT03671044 by Jina Pharmaceuticals Inc., with 657 participants planned, started 2018-07-10 and due to reach its primary completion in 2025-05-31. Interventions recorded: Nanosomal Docetaxel Lipid Suspension (75 mg/m2), Nanosomal Docetaxel Lipid Suspension (100 mg/m2) and Taxotere® (100 mg/m2).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03671044","url":"https://clinicaltrials.gov/study/NCT03671044"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":["intas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03671044","phase":"3","setting":"A Global, Multicenter, Three Arms, Open-label Randomized Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension Compared to Taxotere® (Docetaxel Injection Concentrate) in Triple-negative Breast Cancer Patients With Locally Advanced or Metastatic Breast Cancer After Failure to Prior Chemotherapy","sponsor":"Jina Pharmaceuticals Inc.","started":"2018-07-10","startedType":"actual","enrolled":657,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05144854","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)","aka":[],"tldr":"A phase 3 trial of Ipilimumab, Oxaliplatin and Capecitabine in gastric & gastro-oesophageal junction cancer, run by Ono Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer) is a phase 3 interventional study registered as NCT05144854 by Ono Pharmaceutical Co., Ltd., with 626 participants enrolled, started 2021-11-05 and due to reach its primary completion in 2025-10-20. Interventions recorded: ONO-4538, Ipilimumab, Oxaliplatin, Capecitabine and S-1.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05144854","url":"https://clinicaltrials.gov/study/NCT05144854"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ipilimumab","oxaliplatin","capecitabine"],"companies":["deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05144854","phase":"3","setting":"A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as \"Chemotherapy\") Versus Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)","sponsor":"Ono Pharmaceutical Co., Ltd.","started":"2021-11-05","startedType":"actual","enrolled":626,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06824467","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Pl","aka":["TroFuse-022"],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Bevacizumab, Dexamethasone in ovarian cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103) is a phase 3 interventional study registered as NCT06824467 by Merck Sharp & Dohme LLC, with 770 participants planned, started 2025-04-09 and due to reach its primary completion in 2029-04-27. Interventions recorded: Sacituzumab tirumotecan, Bevacizumab, H1 receptor antagonist, H2 receptor antagonist, Acetaminophen (or equivalent). Conditions listed: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06824467","url":"https://clinicaltrials.gov/study/NCT06824467"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["adc","antiangiogenic","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","bevacizumab","dexamethasone"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06824467","phase":"3","setting":"A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-04-09","startedType":"actual","enrolled":770,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05353257","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage","aka":[],"tldr":"A phase 3 trial of Serplulimab, Carboplatin in small-cell lung cancer, run by Shanghai Henlius Biotech, active and no longer recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer is a phase 3 interventional study registered as NCT05353257 by Shanghai Henlius Biotech, with 511 participants enrolled, started 2022-05-17 and due to reach its primary completion in 2026-06-30. Interventions recorded: HLX10, carboplatin/cisplatin-etoposide, Thoracic radiotherapy, Placebo, Prophylactic Cranial Irradiation (PCI). Conditions listed: Limited-Stage Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05353257","url":"https://clinicaltrials.gov/study/NCT05353257"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","limited-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["serplulimab","carboplatin"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05353257","phase":"3","setting":"A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer","sponsor":"Shanghai Henlius Biotech","started":"2022-05-17","startedType":"actual","enrolled":511,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07284849","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer","aka":[],"tldr":"A phase 3 trial testing INCA33890 in colorectal cancer, now recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer is a phase 3 interventional study registered as NCT07284849, led by Incyte, and recruiting on the registry. Official title: A Randomised, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer. Planned enrolment is 700 participants (estimated). The study started in 2026-03-05 and primary completion is expected in 2028-12-29. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07284849","url":"https://clinicaltrials.gov/study/NCT07284849"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["inca33890"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07284849","phase":"3","setting":"A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer","sponsor":"Incyte","started":"2026-03-05","startedType":"actual","enrolled":700,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06010329","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC","aka":[],"tldr":"A phase 2 trial of Sutetinib Maleate Capsule in non-small-cell lung cancer, run by Teligene US, now recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC is a phase 2 interventional study registered as NCT06010329 by Teligene US, with 66 participants planned, started 2023-12-27 and due to reach its primary completion in 2027-12. Interventions recorded: Sutetinib Maleate Capsule.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06010329","url":"https://clinicaltrials.gov/study/NCT06010329"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":["egfr"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06010329","phase":"2","setting":"A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Uncommon EGFR Mutations Only)","sponsor":"Teligene US","started":"2023-12-27","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06525350","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of the Combination of Glumetinib and Docetaxel（Albumin Bound）Verse Docetaxel for the Treatment of MET-overexpressed","aka":[],"tldr":"A phase 2 trial of docetaxel in lung cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., not yet recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of the Combination of Glumetinib and Docetaxel（Albumin Bound）Verse Docetaxel for the Treatment of MET-overexpressed Non-small Cell Lung Cancer is a phase 2, randomised interventional study registered as NCT06525350 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., with a registry enrolment figure of 256 participants, started 2024-07 and due to reach its primary completion in 2026-12-25. Interventions recorded: Glumetinib tablets; HB1801 (docetaxel, albumin-bound）; Docetaxel. Conditions listed: Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer With MET Overexpression. Primary outcome: Dose-limiting toxicity(DLT) occurrence and incidence; Recommended phase 2 dose(RP2D) of the combination therapy; Adverse events (AE) and serious adverse events (SAE) occurrence and incidence. Lung eligibility wording from the registry: \"Unresectable locally advanced or metastatic non-small cell lung cancer (IIIB, IIIC, or IV according to the 8th edition TNM staging standards of IASLC) confirmed by histology or cytology;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06525350","url":"https://clinicaltrials.gov/study/NCT06525350"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["met-altered-nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06525350","phase":"2","setting":"A Randomized, Controlled, Open-label Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of the Combination of Glumetinib Tablets and Docetaxel for Injection（Albumin Bound）Verse Docetaxel in the Treatment of Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer Patients With MET Overexpression","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","started":"2024-07","startedType":"estimated","enrolled":256,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06010342","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of TL118 in Solid Tumors Patients","aka":[],"tldr":"A phase 2 trial of TL118 Capsule in advanced solid tumours, run by Teligene US, now recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of TL118 in Solid Tumors Patients is a phase 2 interventional study registered as NCT06010342 by Teligene US, with 60 participants planned, started 2023-03-16 and due to reach its primary completion in 2027-12. Interventions recorded: TL118 Capsule.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06010342","url":"https://clinicaltrials.gov/study/NCT06010342"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["ntrk"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06010342","phase":"2","setting":"A Phase 2 Study of TL118 for the Treatment of Patients With Solid Tumors Harboring NTRK Gene Fusions","sponsor":"Teligene US","started":"2023-03-16","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07284758","kind":"trial","name":"A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma","aka":[],"tldr":"A phase 2 trial of Dexamethasone in multiple myeloma, run by C4 Therapeutics, Inc., now recruiting.","summary":"A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT07284758 by C4 Therapeutics, Inc., with 100 participants planned, started 2026-02-18 and due to reach its primary completion in 2030-03. Interventions recorded: Cemsidomide, Dexamethasone. Conditions listed: Multiple Myeloma, Relapsed/Refractory Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07284758","url":"https://clinicaltrials.gov/study/NCT07284758"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy"],"targets":[],"drugs":["dexamethasone"],"companies":["c4-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07284758","phase":"2","setting":"A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma","sponsor":"C4 Therapeutics, Inc.","started":"2026-02-18","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07361510","kind":"trial","name":"A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and P","aka":["ROSETTA Lung-202"],"tldr":"A phase 3 trial of PM8002, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202) is a phase 3 interventional study registered as NCT07361510 by Bristol-Myers Squibb, with 750 participants planned, started 2026-03-12 and due to reach its primary completion in 2031-10-14. Interventions recorded: Pumitamig, Pembrolizumab. Conditions listed: Non-Small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07361510","url":"https://clinicaltrials.gov/study/NCT07361510"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pm8002","pembrolizumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07361510","phase":"3","setting":"ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.","sponsor":"Bristol-Myers Squibb","started":"2026-03-12","startedType":"actual","enrolled":750,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07811193","kind":"trial","name":"A Study to Evaluate the Efficacy of VVD-133214 in Combination With Pembrolizumab Compared With Pembrolizumab Alone in Participants With Advanced Cancer of the Colon or Rectum","aka":[],"tldr":"A phase 2 trial of Pembrolizumab in colorectal cancer, run by Vividion Therapeutics, Inc., now recruiting.","summary":"A Study to Evaluate the Efficacy of VVD-133214 in Combination With Pembrolizumab Compared With Pembrolizumab Alone in Participants With Advanced Cancer of the Colon or Rectum is a phase 2 interventional study registered as NCT07811193 by Vividion Therapeutics, Inc., with 140 participants planned, started 2026-09-11 and due to reach its primary completion in 2028-06-30. Interventions recorded: VVD-133214 and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07811193","url":"https://clinicaltrials.gov/study/NCT07811193"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","msi-high-colorectal","rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07811193","phase":"2","setting":"A Phase 2, Randomized, Open-label Study of VVD-133214 in COmbination With Pembrolizumab Compared to Pembrolizumab Monotherapy in Participants With Advanced Colorectal Adenocarcinoma (CRC) Harboring Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (DMMR)","sponsor":"Vividion Therapeutics, Inc.","started":"2026-09-11","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06041061","kind":"trial","name":"A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SCT1000 in Healthy Women Aged 18-45 Years","aka":[],"tldr":"A phase 3 trial of Recombinant 14-Valent Human Papillomavirus Vaccine（Insect Cell） in advanced solid tumours, run by Sinocelltech Ltd., active and no longer recruiting.","summary":"A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SCT1000 in Healthy Women Aged 18-45 Years is a phase 3 interventional study registered as NCT06041061 by Sinocelltech Ltd., with 18000 participants enrolled, started 2023-08-13 and due to reach its primary completion in 2024-03. Interventions recorded: Recombinant 14-Valent Human Papillomavirus Vaccine（Insect Cell） and placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06041061","url":"https://clinicaltrials.gov/study/NCT06041061"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sinocelltech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06041061","phase":"3","setting":"A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Efficacy, Safety, and Immunogenicity of a 14- Valent Recombinant Human Papillomavirus Vaccine (SCT1000) in Healthy Women Aged 18-45 Years","sponsor":"Sinocelltech Ltd.","started":"2023-08-13","startedType":"actual","enrolled":18000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06828991","kind":"trial","name":"A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP","aka":[],"tldr":"A phase 2 trial of Mosunetuzumab and clonoSEQ in Diffuse large B-cell lymphoma, run by Danielle Wallace, now recruiting.","summary":"A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP is a phase 2 interventional study registered as NCT06828991 by Danielle Wallace, with 40 participants planned, started 2025-09-04 and due to reach its primary completion in 2029-04-01. Interventions recorded: Mosunetuzumab, ClonoSEQ. Conditions recorded: Diffuse Large B-Cell Lymphoma (DLBCL).\n\nLinked to the drug clonoSEQ because the registry names it among its interventions and Diffuse large B-cell lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06828991","url":"https://clinicaltrials.gov/study/NCT06828991"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["mosunetuzumab","clonoseq"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06828991","phase":"2","setting":"ctDNA-Guided Mosunetuzumab Consolidation Therapy in Older Patients With Untreated DLBCL","sponsor":"Danielle Wallace","started":"2025-09-04","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07155174","kind":"trial","name":"A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus St","aka":["SEZanne"],"tldr":"A phase 2 trial of ABBV-706, Atezolizumab, Etoposide in small-cell lung cancer, run by AbbVie, now recruiting.","summary":"A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer is a phase 2 interventional study registered as NCT07155174 by AbbVie, with 180 participants planned, started 2025-11-25 and due to reach its primary completion in 2029-04. Interventions recorded: ABBV-706, Atezolizumab, Etoposide, Carboplatin, Carboplatin. Conditions listed: Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07155174","url":"https://clinicaltrials.gov/study/NCT07155174"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["abbv-706","atezolizumab","etoposide","carboplatin","lurbinectedin"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07155174","phase":"2","setting":"A Phase 2 Randomized, Open Label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Subjects With Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)","sponsor":"AbbVie","started":"2025-11-25","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06428019","kind":"trial","name":"A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)","aka":[],"tldr":"A phase 3 trial of Venetoclax, Acalabrutinib and Obinutuzumab in chronic lymphocytic leukaemia, run by AbbVie, now recruiting.","summary":"A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL) is a phase 3 interventional study registered as NCT06428019 by AbbVie, with 170 participants planned, started 2024-08-05 and due to reach its primary completion in 2028-03. Interventions recorded: Venetoclax, Acalabrutinib and Obinutuzumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06428019","url":"https://clinicaltrials.gov/study/NCT06428019"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["venetoclax","acalabrutinib","obinutuzumab"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06428019","phase":"3","setting":"A Prospective, Open-Label, Phase IIb/III Study to Evaluate the Risk of TLS and Optimization of the Initiation of Venetoclax in Combination With Obinutuzumab or Acalabrutinib With Different Ramp- Up Periods in Previously Untreated Subjects With CLL","sponsor":"AbbVie","started":"2024-08-05","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07691775","kind":"trial","name":"A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of F18 FBPA Injection in advanced solid tumours, run by Heron Neutron Medical Corp., now recruiting.","summary":"A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors is a phase 1/2 interventional study registered as NCT07691775 by Heron Neutron Medical Corp., with 30 participants planned, started 2026-05-20 and due to reach its primary completion in 2026-12. Interventions recorded: F18 FBPA Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07691775","url":"https://clinicaltrials.gov/study/NCT07691775"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["pet","pet-ct"],"targets":[],"drugs":[],"companies":["heron-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07691775","phase":"1/2","setting":"A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors","sponsor":"Heron Neutron Medical Corp.","started":"2026-05-20","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06682793","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression","aka":["DENALI-1"],"tldr":"A phase 1/2 trial of A2B395 in colorectal cancer, non-small-cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma and triple-negative breast cancer, run by A2 Biotherapeutics Inc., now recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression is a phase 1/2 interventional study registered as NCT06682793 by A2 Biotherapeutics Inc., with 240 participants planned, started 2025-05-22 and due to reach its primary completion in 2029-03-31. Interventions recorded: A2B395.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06682793","url":"https://clinicaltrials.gov/study/NCT06682793"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","nsclc","head-and-neck","rcc","tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["a2-biotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06682793","phase":"1/2","setting":"A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression","sponsor":"A2 Biotherapeutics Inc.","started":"2025-05-22","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05736731","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of A2B530, a Logic-gated CAR T, in Participants With Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression","aka":["EVEREST-1"],"tldr":"A phase 1/2 trial of A2B530 in pancreatic ductal adenocarcinoma, non-small-cell lung cancer and colorectal cancer, run by A2 Biotherapeutics Inc., active and no longer recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of A2B530, a Logic-gated CAR T, in Participants With Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression is a phase 1/2 interventional study registered as NCT05736731 by A2 Biotherapeutics Inc., with 160 participants enrolled, started 2023-04-28 and due to reach its primary completion in 2026-12. Interventions recorded: A2B530.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05736731","url":"https://clinicaltrials.gov/study/NCT05736731"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","nsclc","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["tempus","a2-biotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05736731","phase":"1/2","setting":"A Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B530, an Autologous Logic-gated Tmod™ Chimeric Antigen Receptor T Cell (CAR T), in Heterozygous HLA-A*02 Adult Subjects With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression","sponsor":"A2 Biotherapeutics Inc.","started":"2023-04-28","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06166836","kind":"trial","name":"a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of IN10018 in advanced solid tumours, run by InxMed (Shanghai) Co., Ltd., active and no longer recruiting.","summary":"a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors is a phase 1/2 interventional study registered as NCT06166836 by InxMed (Shanghai) Co., Ltd., with 140 participants enrolled, started 2022-10-12 and due to reach its primary completion in 2027-12-31. Interventions recorded: D1553 and IN10018（Ifebemtinib）.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06166836","url":"https://clinicaltrials.gov/study/NCT06166836"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["in10018"],"companies":["inventisbio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06166836","phase":"1/2","setting":"A Phase 1b/II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combined With IN10018 in Subjects With Locally Advanced or Metastatic Solid Tumors With KRAS G12C Mutation","sponsor":"InxMed (Shanghai) Co., Ltd.","started":"2022-10-12","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04980222","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma","aka":[],"tldr":"A phase 2 trial of Glofitamab, Tocilizumab, Doxorubicin, Vincristine, Prednisone and Rituximab in non-Hodgkin lymphoma, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma is a phase 2 interventional study registered as NCT04980222 by Hoffmann-La Roche, with 46 participants enrolled, started 2022-03-22 and due to reach its primary completion in 2024-09-24. Interventions recorded: Glofitamab, Tocilizumab, Doxorubicin, Vincristine, Prednisone and Rituximab. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04980222","url":"https://clinicaltrials.gov/study/NCT04980222"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","dlbcl"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","t-cell-engager"],"targets":[],"drugs":["glofitamab","tocilizumab","doxorubicin","vincristine","prednisone","rituximab"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04980222","phase":"2","setting":"A Phase II Study Evaluating the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma","sponsor":"Hoffmann-La Roche","started":"2022-03-22","startedType":"actual","yearReported":2026,"enrolled":46,"enrolledBasis":"registry","outcomes":[{"endpoint":"End of Treatment Complete Response (EOT CR) Rate","primary":true,"unit":"%","arms":[{"name":"Glofitamab + R-CHOP Immunochemotherapy","n":45,"value":73.3,"note":"95% CI 58.06 to 85.40; Figures from the ClinicalTrials.gov results section (first posted 2026-08-18), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04980222?tab=results"}]},{"id":"nct06780137","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensiv","aka":[],"tldr":"A phase 1/2 trial of Ifinatamab deruxtecan, Durvalumab in small-cell lung cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002) is a phase 1/2 interventional study registered as NCT06780137 by Merck Sharp & Dohme LLC, with 327 participants planned, started 2025-02-27 and due to reach its primary completion in 2029-04-27. Interventions recorded: Gocatamig, Ifinatamab Deruxtecan (I-DXd), Durvalumab. Conditions listed: Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06780137","url":"https://clinicaltrials.gov/study/NCT06780137"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["ifinatamab-deruxtecan","durvalumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06780137","phase":"1/2","setting":"A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer","sponsor":"Merck Sharp & Dohme LLC","started":"2025-02-27","startedType":"actual","enrolled":327,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06758557","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of HB0025 Injection in Patients With Advanced Solid Tumor","aka":[],"tldr":"A phase 1/2 trial of Pemetrexed, Paclitaxel / nab-paclitaxel, Carboplatin in endometrial cancer, run by Huabo Biopharm Co., Ltd., now recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of HB0025 Injection in Patients With Advanced Solid Tumor is a phase 1/2 interventional study registered as NCT06758557 by Huabo Biopharm Co., Ltd., with 282 participants planned, started 2024-01-31 and due to reach its primary completion in 2025-10-31. Interventions recorded: HB0025, Pemetrexed, Paclitaxel, Carboplatin. Conditions listed: Advanced NSCLC, Advanced Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06758557","url":"https://clinicaltrials.gov/study/NCT06758557"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial"],"sections":[],"technologies":[],"targets":[],"drugs":["pemetrexed","paclitaxel","carboplatin"],"companies":["huabo-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06758557","phase":"1/2","setting":"A Multicenter, Open Phase Ib/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HB0025 Injection Combined With Chemotherapy in Patients With Advanced Solid Tumor","sponsor":"Huabo Biopharm Co., Ltd.","started":"2024-01-31","startedType":"actual","enrolled":282,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06051695","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","aka":["EVEREST-2"],"tldr":"A phase 1/2 trial of A2B694 in colorectal cancer, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, ovarian cancer and mesothelioma, run by A2 Biotherapeutics Inc., now recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression is a phase 1/2 interventional study registered as NCT06051695 by A2 Biotherapeutics Inc., with 474 participants planned, started 2024-04-03 and due to reach its primary completion in 2028-06. Interventions recorded: A2B694 and A2B543.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06051695","url":"https://clinicaltrials.gov/study/NCT06051695"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","nsclc","pancreatic","ovarian","mesothelioma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["tempus","a2-biotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06051695","phase":"1/2","setting":"A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Autologous Logic-gated Tmod™ CAR T Products, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","sponsor":"A2 Biotherapeutics Inc.","started":"2024-04-03","startedType":"actual","enrolled":474,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06818643","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002)","aka":[],"tldr":"A phase 1/2 trial of MK-3120 in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002) is a phase 1/2 interventional study registered as NCT06818643 by Merck Sharp & Dohme LLC, with 270 participants planned, started 2025-03-25 and due to reach its primary completion in 2028-10-25. Interventions recorded: MK-3120.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06818643","url":"https://clinicaltrials.gov/study/NCT06818643"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06818643","phase":"1/2","setting":"A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors","sponsor":"Merck Sharp & Dohme LLC","started":"2025-03-25","startedType":"actual","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03671018","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma","aka":[],"tldr":"A phase 1/2 trial of Mosunetuzumab, Polatuzumab vedotin, Tocilizumab in hodgkin lymphoma and non-hodgkin lymphoma, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma is a phase 1/2 interventional study registered as NCT03671018 by Hoffmann-La Roche, with 422 participants planned, started 2018-09-25 and due to reach its primary completion in 2024-01-30. Interventions recorded: Mosunetuzumab (IV), Mosunetuzumab (SC), Polatuzumab vedotin, Tocilizumab, Rituximab. Conditions listed: B-cell Non-Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03671018","url":"https://clinicaltrials.gov/study/NCT03671018"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["adc","t-cell-engager"],"targets":[],"drugs":["mosunetuzumab","polatuzumab-vedotin","tocilizumab","rituximab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03671018","phase":"1/2","setting":"An Open-Label, Randomized, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma","sponsor":"Hoffmann-La Roche","started":"2018-09-25","startedType":"actual","enrolled":422,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06663137","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC","aka":[],"tldr":"A phase 2 trial of Docetaxel and Gemcitabine in bladder & urothelial cancer, run by Relmada Therapeutics, Inc., now recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC is a phase 2 interventional study registered as NCT06663137 by Relmada Therapeutics, Inc., with 70 participants planned, started 2024-08-01 and due to reach its primary completion in 2027-11. Interventions recorded: NDV01 intravesical controlled release formulation of gemcitabine and docetaxel.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06663137","url":"https://clinicaltrials.gov/study/NCT06663137"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["docetaxel","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06663137","phase":"2","setting":"A Single-Center, Open Label, Single Arm Study, to Evaluate the Safety and Efficacy of NDV-01 KIT in Participants With Non Muscle Invasive Bladder Cancer (NMIBC)","sponsor":"Relmada Therapeutics, Inc.","started":"2024-08-01","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07221357","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Parti","aka":["ROSETTA CRC-203"],"tldr":"A phase 2/3 trial of PM8002, FOLFOX, FOLFIRI in colorectal cancer, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer is a phase 2/3 interventional study registered as NCT07221357 by Bristol-Myers Squibb, with 990 participants planned, started 2025-12-31 and due to reach its primary completion in 2030-02-02. Interventions recorded: Pumitamig, FOLFOX, FOLFIRI, Bevacizumab, CAPOX. Conditions listed: Untreated, Unresectable, or Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07221357","url":"https://clinicaltrials.gov/study/NCT07221357"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["pm8002","folfox","folfiri","bevacizumab","capox"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07221357","phase":"2/3","setting":"ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer","sponsor":"Bristol-Myers Squibb","started":"2025-12-31","startedType":"actual","enrolled":990,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07221149","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)","aka":["ROSETTA Gastric-204"],"tldr":"A phase 2/3 trial of PM8002 and Nivolumab in gastric & gastro-oesophageal junction cancer, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204) is a phase 2/3 interventional study registered as NCT07221149 by Bristol-Myers Squibb, with 690 participants planned, started 2026-03-13 and due to reach its primary completion in 2030-11-08. Interventions recorded: Pumitamig, Folfox, Capox and Nivolumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07221149","url":"https://clinicaltrials.gov/study/NCT07221149"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pm8002","nivolumab"],"companies":["bms","biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07221149","phase":"2/3","setting":"ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma","sponsor":"Bristol-Myers Squibb","started":"2026-03-13","startedType":"actual","enrolled":690,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07570823","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","aka":[],"tldr":"A phase 3 trial testing SCTB35 in diffuse large B-cell lymphoma, now recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma is a phase 3 interventional study registered as NCT07570823, led by Sinocelltech, and recruiting on the registry. Official title: A Phase 3 Randomised, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Planned enrolment is 101 participants (estimated). The study started in 2026-06-04 and primary completion is expected in 2027-11. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07570823","url":"https://clinicaltrials.gov/study/NCT07570823"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["sctb35"],"companies":["sinocelltech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07570823","phase":"3","setting":"A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","sponsor":"Sinocelltech","started":"2026-06-04","startedType":"actual","enrolled":101,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07562022","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma","aka":[],"tldr":"A phase 3 trial testing SCTB35 in follicular lymphoma, now recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma is a phase 3 interventional study registered as NCT07562022, led by Sinocelltech, and recruiting on the registry. Official title: A Phase 3 Randomised, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide Versus Rituximab and Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma. Planned enrolment is 93 participants (estimated). The study started in 2026-06-09 and primary completion is expected in 2028-05. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07562022","url":"https://clinicaltrials.gov/study/NCT07562022"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["sctb35"],"companies":["sinocelltech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07562022","phase":"3","setting":"A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide Versus Rituximab and Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma","sponsor":"Sinocelltech","started":"2026-06-09","startedType":"actual","enrolled":93,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07297329","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant","aka":[],"tldr":"A phase 3 trial testing SCTC21C in multiple myeloma, now recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant is a phase 3 interventional study registered as NCT07297329, led by Sinocelltech, and recruiting on the registry. Official title: A Phase 3 Randomised, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant. Planned enrolment is 292 participants (estimated). The study started in 2025-12-29 and primary completion is expected in 2027-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07297329","url":"https://clinicaltrials.gov/study/NCT07297329"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-transplant-ineligible"],"sections":[],"technologies":[],"targets":[],"drugs":["sctc21c"],"companies":["sinocelltech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07297329","phase":"3","setting":"A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant","sponsor":"Sinocelltech","started":"2025-12-29","startedType":"actual","enrolled":292,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06973187","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","aka":[],"tldr":"A phase 3 trial of Pirtobrutinib in chronic lymphocytic leukaemia, run by BeOne Medicines, now recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma is a phase 3 interventional study registered as NCT06973187 by BeOne Medicines, with 500 participants planned, started 2025-09-04 and due to reach its primary completion in 2028-04-17. Interventions recorded: Tacabrutideg and Pirtobrutinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06973187","url":"https://clinicaltrials.gov/study/NCT06973187"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["pirtobrutinib"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06973187","phase":"3","setting":"A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","sponsor":"BeOne Medicines","started":"2025-09-04","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06948448","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard ","aka":[],"tldr":"A phase 2 trial of Nivolumab, CAPOX, Bevacizumab in colorectal cancer, run by Ono Pharmaceutical Co., Ltd., now recruiting.","summary":"A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer is a phase 2 interventional study registered as NCT06948448 by Ono Pharmaceutical Co., Ltd., with 144 participants planned, started 2025-11-18 and due to reach its primary completion in 2028-02-15. Interventions recorded: ONO-4578, Opdivo®, Oxaliplatin, 5-Fluorouracil, Bevacizumab. Conditions listed: Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06948448","url":"https://clinicaltrials.gov/study/NCT06948448"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["nivolumab","capox","bevacizumab","flot"],"companies":["deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06948448","phase":"2","setting":"A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo® in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care for First-line Treatment of Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer","sponsor":"Ono Pharmaceutical Co., Ltd.","started":"2025-11-18","startedType":"actual","enrolled":144,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04570423","kind":"trial","name":"A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","aka":[],"tldr":"A phase 2 trial of Eflapegrastim in non-Hodgkin lymphoma, run by Spectrum Pharmaceuticals, Inc, now recruiting.","summary":"A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy is a phase 2 interventional study registered as NCT04570423 by Spectrum Pharmaceuticals, Inc, with 40 participants planned, started 2021-05-20 and due to reach its primary completion in 2027-10. Interventions recorded: Eflapegrastim and Chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04570423","url":"https://clinicaltrials.gov/study/NCT04570423"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["eflapegrastim"],"companies":["spectrum-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04570423","phase":"2","setting":"A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","sponsor":"Spectrum Pharmaceuticals, Inc","started":"2021-05-20","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05804669","kind":"trial","name":"A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome","aka":[],"tldr":"A phase 1/2 trial of atumelnant in pituitary tumours and pituitary carcinoma, run by Crinetics Pharmaceuticals Inc., active and no longer recruiting.","summary":"A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome is a phase 1/2 interventional study registered as NCT05804669 by Crinetics Pharmaceuticals Inc., with 19 participants enrolled, started 2023-10-12 and due to reach its primary completion in 2026-10. Interventions recorded: atumelnant.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05804669","url":"https://clinicaltrials.gov/study/NCT05804669"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pituitary-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["crinetics-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05804669","phase":"1/2","setting":"A Phase 1b/2a Open-label Multiple-ascending Dose Exploratory Study of CRN04894 in ACTH-dependent Cushing's Syndrome (Cushing's Disease or Ectopic ACTH Syndrome)","sponsor":"Crinetics Pharmaceuticals Inc.","started":"2023-10-12","startedType":"actual","enrolled":19,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06116136","kind":"trial","name":"A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in gastric & gastro-oesophageal junction cancer, run by Servier Bio-Innovation LLC, active and no longer recruiting.","summary":"A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers. is a phase 1/2 interventional study registered as NCT06116136 by Servier Bio-Innovation LLC, with 48 participants enrolled, started 2024-08-31 and due to reach its primary completion in 2027-08. Interventions recorded: S095029 and pembrolizumab 200 mg (KEYTRUDA ®).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06116136","url":"https://clinicaltrials.gov/study/NCT06116136"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","gastric-msi-high"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06116136","phase":"1/2","setting":"Open Label, Non-randomized, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of S095029 (Anti-NKG2A Antibody) as a Part of Combination Therapy in Participants With Locally Advanced and Unresectable or Metastatic MSI-H/dMMR Gastro-esophageal Junction /Gastric Cancer","sponsor":"Servier Bio-Innovation LLC","started":"2024-08-31","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05824975","kind":"trial","name":"A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizu","aka":["KEYNOTE-G08"],"tldr":"A phase 1/2 trial of Doxorubicin, Paclitaxel / nab-paclitaxel, Bevacizumab in sarcomas and ovarian cancer, run by GI Innovation, Inc., now recruiting.","summary":"A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08) is a phase 1/2 interventional study registered as NCT05824975 by GI Innovation, Inc., with 358 participants planned, started 2023-05-30 and due to reach its primary completion in 2025-11-12. Interventions recorded: GI-102 subcutaneous (SC), GI-102, doxorubicin, paclitaxel, bevacizumab. Conditions listed: Advanced Solid Tumor, Metastatic Solid Tumor, Soft Tissue Sarcoma (STS), Platinum-resistant Ovarian Cancer (PROC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05824975","url":"https://clinicaltrials.gov/study/NCT05824975"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sarcoma","ovarian","hcc","colorectal","melanoma"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":[],"drugs":["doxorubicin","paclitaxel","bevacizumab","eribulin","trastuzumab-deruxtecan","pembrolizumab"],"companies":["gi-innovation"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05824975","phase":"1/2","setting":"An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)","sponsor":"GI Innovation, Inc.","started":"2023-05-30","startedType":"actual","enrolled":358,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07291076","kind":"trial","name":"A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unres","aka":["ROSETTA HCC-206"],"tldr":"A phase 1/2 trial of PM8002, Ipilimumab in hepatocellular carcinoma, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206) is a phase 1/2 interventional study registered as NCT07291076 by Bristol-Myers Squibb, with 198 participants planned, started 2026-03-16 and due to reach its primary completion in 2029-10-15. Interventions recorded: Pumitamig, Ipilimumab. Conditions listed: Hepatocellular Carcinoma (HCC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07291076","url":"https://clinicaltrials.gov/study/NCT07291076"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pm8002","ipilimumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07291076","phase":"1/2","setting":"ROSETTA HCC-206: An Open-Label, Multi-Center, Randomized Phase 1/2 Study of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC)","sponsor":"Bristol-Myers Squibb","started":"2026-03-16","startedType":"actual","enrolled":198,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07362459","kind":"trial","name":"A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial testing SCTB14 in non-small-cell lung cancer, now recruiting.","summary":"A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT07362459, led by Sinocelltech, and recruiting on the registry. Official title: A Phase III, Randomised, Double-blind, Multicenter Clinical Study to Evaluate the Efficacy and Safety of SCTB14 Versus Pembrolizumab as First-Line Therapy in Patients With Driver Gene-Negative, TPS ≥10% Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Planned enrolment is 246 participants (estimated). The study started in 2025-12-30 and primary completion is expected in 2027-07. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07362459","url":"https://clinicaltrials.gov/study/NCT07362459"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["sctb14"],"companies":["sinocelltech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07362459","phase":"3","setting":"A Phase III, Randomized, Double-blind, Multicenter Clinical Study to Evaluate the Efficacy and Safety of SCTB14 Versus Pembrolizumab as First-Line Therapy in Patients With Driver Gene-Negative, TPS ≥10% Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Sinocelltech","started":"2025-12-30","startedType":"actual","enrolled":246,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04077723","kind":"trial","name":"A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combi","aka":[],"tldr":"A phase 1/2 trial of Englumafusp alfa, Obinutuzumab, Glofitamab in non-hodgkin lymphoma, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma is a phase 1/2 interventional study registered as NCT04077723 by Hoffmann-La Roche, with 498 participants planned, started 2019-08-13 and due to reach its primary completion in 2027-03-31. Interventions recorded: Englumafusp alfa, Obinutuzumab, Glofitamab, Tocilizumab. Conditions listed: Lymphoma, Non-Hodgkin. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04077723","url":"https://clinicaltrials.gov/study/NCT04077723"}],"tags":["ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":["monoclonal-antibody","t-cell-engager"],"targets":[],"drugs":["englumafusp-alfa","obinutuzumab","glofitamab","tocilizumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04077723","phase":"1/2","setting":"An Open-Label, Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa (RO7227166, A CD19 Targeted 4-1BB Ligand) in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-treatment Dose of Obinutuzumab Administered in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma","sponsor":"Hoffmann-La Roche","started":"2019-08-13","startedType":"actual","enrolled":498,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06609005","kind":"trial","name":"A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer","aka":[],"tldr":"A phase 1/2 trial of INV-9956 in prostate cancer, run by Shenzhen Ionova Life Sciences Co., Ltd., now recruiting.","summary":"A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer is a phase 1/2 interventional study registered as NCT06609005 by Shenzhen Ionova Life Sciences Co., Ltd., with 84 participants planned, started 2025-01-23 and due to reach its primary completion in 2028-01-17. Interventions recorded: INV-9956.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06609005","url":"https://clinicaltrials.gov/study/NCT06609005"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shenzhen-ionova-life-sciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06609005","phase":"1/2","setting":"A Phase 1 and Phase 2, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Evidence of Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer","sponsor":"Shenzhen Ionova Life Sciences Co., Ltd.","started":"2025-01-23","startedType":"actual","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02908906","kind":"trial","name":"A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers","aka":[],"tldr":"A phase 1/2 trial of Cetrelimab in advanced solid tumours, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers is a phase 1/2 interventional study registered as NCT02908906 by Janssen Research & Development, LLC, with 234 participants enrolled, started 2016-11-21 and due to reach its primary completion in 2023-11-17. Interventions recorded: JNJ-63723283.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02908906","url":"https://clinicaltrials.gov/study/NCT02908906"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cetrelimab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02908906","phase":"1/2","setting":"63723283LUC1001: A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancers","sponsor":"Janssen Research & Development, LLC","started":"2016-11-21","startedType":"actual","enrolled":234,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07498725","kind":"trial","name":"A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of LRK-4189 Alone and in Combination in Patients With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of LRK-4189 escalation in advanced solid tumours, run by LARKSPUR BIOSCIENCES, INC., now recruiting.","summary":"A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of LRK-4189 Alone and in Combination in Patients With Solid Tumors is a phase 1/2 interventional study registered as NCT07498725 by LARKSPUR BIOSCIENCES, INC., with 120 participants planned, started 2026-07-07 and due to reach its primary completion in 2029-06. Interventions recorded: LRK-4189 escalation, LRK-4189 expansion, LRK-4189 optimization and Chemo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07498725","url":"https://clinicaltrials.gov/study/NCT07498725"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07498725","phase":"1/2","setting":"A Phase 1b-2, Open-Label, Dose-Escalation, Expansion and Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of LRK-4189 Alone and in Combination With mFOLFOX6 or FOLFIRI in Patients With Solid Tumors","sponsor":"LARKSPUR BIOSCIENCES, INC.","started":"2026-07-07","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07223047","kind":"trial","name":"A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advance","aka":[],"tldr":"A phase 1/2 trial of Gemcitabine, Paclitaxel / nab-paclitaxel, Cetuximab in non-small-cell lung cancer and small-cell lung cancer, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies is a phase 1/2 interventional study registered as NCT07223047 by Bristol-Myers Squibb, with 252 participants planned, started 2025-11-25 and due to reach its primary completion in 2028-10-13. Interventions recorded: BMS-986523, Gemcitabine, Nab-Paclitaxel, Cetuximab, Pembrolizumab. Conditions listed: Advanced Solid Malignancies, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07223047","url":"https://clinicaltrials.gov/study/NCT07223047"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","colorectal","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["gemcitabine","paclitaxel","cetuximab","pembrolizumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07223047","phase":"1/2","setting":"A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies","sponsor":"Bristol-Myers Squibb","started":"2025-11-25","startedType":"actual","enrolled":252,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04300556","kind":"trial","name":"A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types","aka":[],"tldr":"A phase 1/2 trial of Prednisone, Dexamethasone and Lenvatinib in advanced solid tumours, run by Eisai Inc., now recruiting.","summary":"A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types is a phase 1/2 interventional study registered as NCT04300556 by Eisai Inc., with 182 participants planned, started 2020-08-06 and due to reach its primary completion in 2030-08-08. Interventions recorded: Farletuzumab ecteribulin, Prednisone, Prednisolone, Dexamethasone and Lenvatinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04300556","url":"https://clinicaltrials.gov/study/NCT04300556"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["prednisone","dexamethasone","lenvatinib","farletuzumab-ecteribulin"],"companies":["eisai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04300556","phase":"1/2","setting":"A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types","sponsor":"Eisai Inc.","started":"2020-08-06","startedType":"actual","enrolled":182,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07293351","kind":"trial","name":"A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal ","aka":["ROSETTA RCC-208"],"tldr":"A phase 1/2 trial of PM8002, Ipilimumab, Cabozantinib in renal cell carcinoma, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) is a phase 1/2 interventional study registered as NCT07293351 by Bristol-Myers Squibb, with 474 participants planned, started 2026-03-26 and due to reach its primary completion in 2029-11-28. Interventions recorded: Pumitamig, Ipilimumab, Cabozantinib, Casdatifan. Conditions listed: Advanced Renal Cell Carcinoma (RCC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07293351","url":"https://clinicaltrials.gov/study/NCT07293351"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002","ipilimumab","cabozantinib"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07293351","phase":"1/2","setting":"ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC)","sponsor":"Bristol-Myers Squibb","started":"2026-03-26","startedType":"actual","enrolled":474,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06618287","kind":"trial","name":"A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Osimertinib, Pembrolizumab, Nivolumab and PM8002 in advanced solid tumours, run by Bristol-Myers Squibb, now recruiting.","summary":"A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06618287 by Bristol-Myers Squibb, with 416 participants planned, started 2025-02-04 and due to reach its primary completion in 2031-02-26. Interventions recorded: BMS-986507, Osimertinib, Pembrolizumab, Nivolumab and Pumitamig.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06618287","url":"https://clinicaltrials.gov/study/NCT06618287"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["osimertinib","pembrolizumab","nivolumab","pm8002"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06618287","phase":"1/2","setting":"A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors","sponsor":"Bristol-Myers Squibb","started":"2025-02-04","startedType":"actual","enrolled":416,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06656390","kind":"trial","name":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ALK201 in advanced solid tumours, run by Shanghai Allink Biotherapeutics Co., Ltd., now recruiting.","summary":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06656390 by Shanghai Allink Biotherapeutics Co., Ltd., with 202 participants planned, started 2024-10-24 and due to reach its primary completion in 2027-10-22. Interventions recorded: ALK201.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06656390","url":"https://clinicaltrials.gov/study/NCT06656390"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06656390","phase":"1/2","setting":"A First-in-Human, Open-Label, Multi-Center Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK201 for Injection in Adult Participants With Advanced Solid Tumors","sponsor":"Shanghai Allink Biotherapeutics Co., Ltd.","started":"2024-10-24","startedType":"actual","enrolled":202,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07612891","kind":"trial","name":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor","aka":[],"tldr":"A phase 1/2 trial of INV-6452 in ovarian cancer, endometrial cancer and HR-positive / HER2-negative breast cancer, run by Shenzhen Ionova Life Sciences Co., Ltd., now recruiting.","summary":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor is a phase 1/2 interventional study registered as NCT07612891 by Shenzhen Ionova Life Sciences Co., Ltd., with 201 participants planned, started 2025-07-04 and due to reach its primary completion in 2028-02-04. Interventions recorded: INV-6452.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07612891","url":"https://clinicaltrials.gov/study/NCT07612891"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","endometrial","breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shenzhen-ionova-life-sciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07612891","phase":"1/2","setting":"A Phase 1 and Phase 2, First-in-Human, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor","sponsor":"Shenzhen Ionova Life Sciences Co., Ltd.","started":"2025-07-04","startedType":"actual","enrolled":201,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07610798","kind":"trial","name":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations","aka":[],"tldr":"A phase 1/2 trial of INV-8989 in colorectal cancer, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, ovarian cancer, endometrial cancer and biliary tract cancer, run by Shenzhen Ionova Life Sciences Co., Ltd., now recruiting.","summary":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations is a phase 1/2 interventional study registered as NCT07610798 by Shenzhen Ionova Life Sciences Co., Ltd., with 178 participants planned, started 2026-06-01 and due to reach its primary completion in 2029-05. Interventions recorded: INV-8989.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07610798","url":"https://clinicaltrials.gov/study/NCT07610798"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","nsclc","pancreatic","ovarian","endometrial","cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shenzhen-ionova-life-sciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07610798","phase":"1/2","setting":"A Phase I/II, Open-Label, Multi-Center, Dose Escalation and Cohort Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations","sponsor":"Shenzhen Ionova Life Sciences Co., Ltd.","started":"2026-06-01","startedType":"actual","enrolled":178,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06746116","kind":"trial","name":"A Study to Evaluate the Use of Durvalumab in Combination With Platinum-based Chemotherapy Followed by Durvalumab With Olaparib as First-line Treatment","aka":["DUoENDE"],"tldr":"A phase 3 trial of Durvalumab in endometrial cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study to Evaluate the Use of Durvalumab in Combination With Platinum-based Chemotherapy Followed by Durvalumab With Olaparib as First-line Treatment in Advanced or Recurrent Endometrial Cancer in Spain is a phase 3 interventional study registered as NCT06746116 by AstraZeneca, with 45 participants enrolled, started 2024-12-30 and due to reach its primary completion in 2028-11-30. Interventions recorded: Durvalumab + Chemotherapy phase, Durvalumab + Olaparib phase. Conditions listed: Advanced or Recurrent Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06746116","url":"https://clinicaltrials.gov/study/NCT06746116"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06746116","phase":"3","setting":"A Phase IIIB Study to Evaluate the Use of Durvalumab in Combination With Platinum-based Chemotherapy Followed by Durvalumab With Olaparib as First-line Treatment in Patients With Newly Diagnosed pMMR Advanced or Recurrent Endometrial Cancer in Spain","sponsor":"AstraZeneca","started":"2024-12-30","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05941507","kind":"trial","name":"A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of LCB84 in advanced solid tumours, run by LigaChem Biosciences, Inc., now recruiting.","summary":"A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05941507 by LigaChem Biosciences, Inc., with 300 participants planned, started 2023-10-05 and due to reach its primary completion in 2027-01. Interventions recorded: LCB84 and Anti-PD-1 monoclonal antibody.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05941507","url":"https://clinicaltrials.gov/study/NCT05941507"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["lcb84"],"companies":["ligachem-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05941507","phase":"1/2","setting":"A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, in Patients With Advanced Solid Tumors","sponsor":"LigaChem Biosciences, Inc.","started":"2023-10-05","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06946797","kind":"trial","name":"A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Pre","aka":[],"tldr":"A phase 2 trial of Nivolumab, Ipilimumab, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) is a phase 2 interventional study registered as NCT06946797 by Bristol-Myers Squibb, with 76 participants planned, started 2025-09-19 and due to reach its primary completion in 2027-02-05. Interventions recorded: Nivolumab, Ipilimumab, Carboplatin, Paclitaxel, Pemetrexed. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06946797","url":"https://clinicaltrials.gov/study/NCT06946797"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab","carboplatin","paclitaxel","pemetrexed","cisplatin"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06946797","phase":"2","setting":"A Phase 2, Open-label, Randomized Trial to Evaluate Two Dosing Regimens of Subcutaneous Formulation of Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent NSCLC","sponsor":"Bristol-Myers Squibb","started":"2025-09-19","startedType":"actual","enrolled":76,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06101134","kind":"trial","name":"A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed","aka":[],"tldr":"A phase 2 trial of Nivolumab, Relatlimab + nivolumab in melanoma, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations is a phase 2 interventional study registered as NCT06101134 by Bristol-Myers Squibb, with 100 participants enrolled, started 2023-11-06 and due to reach its primary completion in 2025-04-10. Interventions recorded: relatlimab+nivolumab, relatlimab+nivolumab+rHuPH20, nivolumab, nivolumab+rHuPH20. Conditions listed: Melanoma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06101134","url":"https://clinicaltrials.gov/study/NCT06101134"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","relatlimab-nivolumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06101134","phase":"2","setting":"A Phase 2 Open-label, Two-cohort Study to Evaluate Patient Preference for Nivolumab + Relatlimab Fixed-dose Combination Subcutaneous Versus Nivolumab + Relatlimab Fixed-dose Combination Intravenous and Nivolumab Subcutaneous Versus Nivolumab Intravenous in Participants With Melanoma","sponsor":"Bristol-Myers Squibb","started":"2023-11-06","startedType":"actual","yearReported":2026,"enrolled":100,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Evaluable Participants That Prefer SC Route of Administration Using the Patient Experience and Preference Questionnaire (PEPQ) (Question 7) After Cycle 4 Day 1 Dose","primary":true,"unit":"%","arms":[{"name":"Cohort 1: Metastatic Melanoma","n":41,"value":78,"note":"95% CI 62.4 to 89.4; Figures from the ClinicalTrials.gov results section (first posted 2026-04-09), not from a publication"},{"name":"Cohort 2: Resected Melanoma","n":48,"value":70.8,"note":"95% CI 55.9 to 83.0"}],"source":"https://clinicaltrials.gov/study/NCT06101134?tab=results"}]},{"id":"nct06717347","kind":"trial","name":"A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituxi","aka":[],"tldr":"A phase 3 trial of Zilovertamab vedotin, Rituximab, Cyclophosphamide in diffuse large b-cell lymphoma, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010) is a phase 3 interventional study registered as NCT06717347 by Merck Sharp & Dohme LLC, with 1046 participants planned, started 2025-01-27 and due to reach its primary completion in 2029-07-02. Interventions recorded: Zilovertamab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Rituximab Biosimilar. Conditions listed: Diffuse Large B-Cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06717347","url":"https://clinicaltrials.gov/study/NCT06717347"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["zilovertamab-vedotin","rituximab","cyclophosphamide","doxorubicin","prednisone","vincristine"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06717347","phase":"3","setting":"A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-01-27","startedType":"actual","enrolled":1046,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07354022","kind":"trial","name":"A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy","aka":[],"tldr":"A phase 3 trial testing HRS-8080 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy is a phase 3 interventional study registered as NCT07354022, led by Shandong Suncadia Medicine, and recruiting on the registry. Official title: A Multicenter, Open-label, Randomised Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy. Planned enrolment is 912 participants (estimated). The study started in 2026-05-05 and primary completion is expected in 2028-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07354022","url":"https://clinicaltrials.gov/study/NCT07354022"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["hrs-8080"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07354022","phase":"3","setting":"A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy","sponsor":"Shandong Suncadia Medicine","started":"2026-05-05","startedType":"actual","enrolled":912,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06508216","kind":"trial","name":"A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negat","aka":["COMPASS-TNBC"],"tldr":"A phase 1/2 trial of datopotamab deruxtecan and durvalumab in triple-negative breast cancer, run by Gustave Roussy, Cancer Campus, Grand Paris, now recruiting.","summary":"A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer is a phase 1/2, randomised interventional study registered as NCT06508216 by Gustave Roussy, Cancer Campus, Grand Paris, with a registry enrolment figure of 50 participants, started 2024-07-05 and due to reach its primary completion in 2025-12-17. Interventions recorded: Dato-DXd; Durvalumab. Conditions listed: Breast Cancer. Triple-negative eligibility wording from the registry: \"Patients who have early relapsed triple negative breast cancer i\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06508216","url":"https://clinicaltrials.gov/study/NCT06508216"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["datopotamab-deruxtecan","durvalumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06508216","phase":"1/2","setting":"A Phase Ib/II, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","started":"2024-07-05","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06349980","kind":"trial","name":"A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.","aka":[],"tldr":"A phase 2 trial of Serplulimab in hepatocellular carcinoma, run by Shanghai Henlius Biotech, now recruiting.","summary":"A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. is a phase 2 interventional study registered as NCT06349980 by Shanghai Henlius Biotech, with 117 participants planned, started 2024-08-05 and due to reach its primary completion in 2027-02-10. Interventions recorded: HLX53 (1000mg), HLX53 (2000mg), HLX10 and HLX04.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06349980","url":"https://clinicaltrials.gov/study/NCT06349980"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["serplulimab"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06349980","phase":"2","setting":"A Randomized, Double-blind, Multi-center, Phase II Study to Evaluate the Anti-tumor Efficacy, Safety and Tolerability of HLX53 (an Anti-TIGIT Fc Fusion Protein) Combined with Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) Compared to Placebo + Serplulimab + HLX04, in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.","sponsor":"Shanghai Henlius Biotech","started":"2024-08-05","startedType":"actual","enrolled":117,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05954429","kind":"trial","name":"A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-cente","aka":[],"tldr":"A phase 2 trial of serplulimab and fruquintinib in colorectal cancer, run by Fudan University, now recruiting.","summary":"A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study is a phase 2, interventional study registered as NCT05954429 by Fudan University, with a registry enrolment figure of 50 participants, started 2023-07-20 and due to reach its primary completion in 2026-12-28. Interventions recorded: serplulimab; Fruquintinib. Conditions listed: Colorectal Cancer. Primary outcome: objective response rate (ORR). Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05954429","url":"https://clinicaltrials.gov/study/NCT05954429"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["serplulimab","fruquintinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05954429","phase":"2","setting":"A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study","sponsor":"Fudan University","started":"2023-07-20","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04590326","kind":"trial","name":"A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamata","aka":[],"tldr":"A phase 1/2 trial of Cemiplimab in ovarian cancer and endometrial cancer, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab is a phase 1/2 interventional study registered as NCT04590326 by Regeneron Pharmaceuticals, with 612 participants planned, started 2020-12-08 and due to reach its primary completion in 2027-03-25. Interventions recorded: REGN5668, Cemiplimab, Ubamatamab, Sarilumab, Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]. Conditions listed: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04590326","url":"https://clinicaltrials.gov/study/NCT04590326"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","endometrial"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04590326","phase":"1/2","setting":"A Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies","sponsor":"Regeneron Pharmaceuticals","started":"2020-12-08","startedType":"actual","enrolled":612,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07475806","kind":"trial","name":"A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder","aka":[],"tldr":"A phase 2 trial of Enfortumab vedotin and Pembrolizumab in bladder & urothelial cancer, run by Astellas Pharma Global Development, Inc., now recruiting.","summary":"A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder is a phase 2 interventional study registered as NCT07475806 by Astellas Pharma Global Development, Inc., with 240 participants planned, started 2026-03-12 and due to reach its primary completion in 2027-11-30. Interventions recorded: Enfortumab Vedotin and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07475806","url":"https://clinicaltrials.gov/study/NCT07475806"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["enfortumab-vedotin","pembrolizumab"],"companies":["astellas","pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07475806","phase":"2","setting":"An Open-label, Single-Arm, Phase 2 Study to Evaluate Enfortumab Vedotin Plus Pembrolizumab for Bladder Preservation in Participants With Muscle-invasive Bladder Cancer (EV-209)","sponsor":"Astellas Pharma Global Development, Inc.","started":"2026-03-12","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06747585","kind":"trial","name":"A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ALE.P02 in non-small-cell lung cancer, head and neck squamous cell carcinoma and oesophageal cancer, run by Alentis Therapeutics AG, now recruiting.","summary":"A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors is a phase 1/2 interventional study registered as NCT06747585 by Alentis Therapeutics AG, with 170 participants planned, started 2024-12-16 and due to reach its primary completion in 2028-02-15. Interventions recorded: ALE.P02.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06747585","url":"https://clinicaltrials.gov/study/NCT06747585"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","head-and-neck","esophageal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["alentis-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06747585","phase":"1/2","setting":"A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors","sponsor":"Alentis Therapeutics AG","started":"2024-12-16","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07169734","kind":"trial","name":"A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ALE.P03 in non-small-cell lung cancer, colorectal cancer, biliary tract cancer and bladder & urothelial cancer, run by Alentis Therapeutics AG, now recruiting.","summary":"A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors is a phase 1/2 interventional study registered as NCT07169734 by Alentis Therapeutics AG, with 180 participants planned, started 2025-08-26 and due to reach its primary completion in 2029-04-05. Interventions recorded: ALE.P03.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07169734","url":"https://clinicaltrials.gov/study/NCT07169734"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","colorectal","cholangiocarcinoma","urothelial"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["alentis-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07169734","phase":"1/2","setting":"A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors","sponsor":"Alentis Therapeutics AG","started":"2025-08-26","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07538804","kind":"trial","name":"A Study to Investigate ANS02 in Participants With EGFR Mutation-Positive Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of ANS02 in non-small-cell lung cancer, run by Avistone Biotechnology Co., Ltd., now recruiting.","summary":"A Study to Investigate ANS02 in Participants With EGFR Mutation-Positive Non-Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT07538804 by Avistone Biotechnology Co., Ltd., with 294 participants planned, started 2026-07-10 and due to reach its primary completion in 2029-06-30. Interventions recorded: ANS02.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07538804","url":"https://clinicaltrials.gov/study/NCT07538804"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["avistone-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07538804","phase":"1/2","setting":"A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS02 in Participants With EGFR Mutation-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"Avistone Biotechnology Co., Ltd.","started":"2026-07-10","startedType":"estimated","enrolled":294,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06399757","kind":"trial","name":"A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of APL-5125 in colorectal cancer, biliary tract cancer, appendiceal cancer and pseudomyxoma peritonei, pancreatic ductal adenocarcinoma, gastric & gastro-oesophageal junction cancer and endometrial cancer, run by Apollo Therapeutics Ltd, active and no longer recruiting.","summary":"A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06399757 by Apollo Therapeutics Ltd, with 100 participants enrolled, started 2024-06-18 and due to reach its primary completion in 2027-04. Interventions recorded: APL-5125.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06399757","url":"https://clinicaltrials.gov/study/NCT06399757"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","cholangiocarcinoma","appendiceal","pancreatic","gastric","endometrial"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06399757","phase":"1/2","setting":"A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors","sponsor":"Apollo Therapeutics Ltd","started":"2024-06-18","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"invincible-3","kind":"trial","name":"A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)","aka":["INVINCIBLE-3"],"tldr":"A phase 3 trial testing INT230-6 in sarcomas, now recruiting.","summary":"A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) is a phase 3 interventional study registered as NCT06263231, led by Intensity Therapeutics with Premier Research, and recruiting on the registry. Official title: A Multicenter, Randomised, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3). Planned enrolment is 333 participants (estimated). The study started in 2024-06-28 and primary completion is expected in 2027-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06263231","url":"https://clinicaltrials.gov/study/NCT06263231"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["int230-6"],"companies":["intensity-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06263231","phase":"3","setting":"A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)","sponsor":"Intensity Therapeutics","started":"2024-06-28","startedType":"actual","enrolled":333,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05952037","kind":"trial","name":"A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia","aka":[],"tldr":"A phase 2 trial of Sonrotoclax and Zanubrutinib in waldenström macroglobulinaemia, run by BeOne Medicines, active and no longer recruiting.","summary":"A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia is a phase 2 interventional study registered as NCT05952037 by BeOne Medicines, with 114 participants enrolled, started 2023-10-23 and due to reach its primary completion in 2026-09-22. Interventions recorded: Sonrotoclax and Zanubrutinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05952037","url":"https://clinicaltrials.gov/study/NCT05952037"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["waldenstrom"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["sonrotoclax","zanubrutinib"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05952037","phase":"2","setting":"An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of the BCL2 Inhibitor Sonrotoclax (BGB-11417) as Monotherapy and in Combination With Zanubrutinib (BGB-3111) in Patients With Waldenström Macroglobulinemia","sponsor":"BeOne Medicines","started":"2023-10-23","startedType":"actual","enrolled":114,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05941897","kind":"trial","name":"A Study to Investigate Efficacy and Safety of Ceralasertib Plus Durvalumab in Participants Aged ≥ 18 Years With Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Progressed on or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy","aka":["LOTOS"],"tldr":"A phase 2 trial of Ceralasertib and Durvalumab in non-small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study to Investigate Efficacy and Safety of Ceralasertib Plus Durvalumab in Participants Aged ≥ 18 Years With Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Progressed on or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy is a phase 2 interventional study registered as NCT05941897 by AstraZeneca, with 39 participants enrolled, started 2023-06-21 and due to reach its primary completion in 2024-07-29. Interventions recorded: Ceralasertib and Durvalumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05941897","url":"https://clinicaltrials.gov/study/NCT05941897"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ceralasertib","durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05941897","phase":"2","setting":"A Phase II, Open-label, Multicentre, Non-comparative, Single-arm Local Study of Ceralasertib Plus Durvalumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy","sponsor":"AstraZeneca","started":"2023-06-21","startedType":"actual","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04214288","kind":"trial","name":"A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer","aka":["SERENA-2"],"tldr":"A phase 2 trial of Camizestrant and Fulvestrant in HR-positive / HER2-negative breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer is a phase 2 interventional study registered as NCT04214288 by AstraZeneca, with 240 participants enrolled, started 2020-04-22 and due to reach its primary completion in 2022-08-30. Interventions recorded: AZD9833 and Fulvestrant. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04214288","url":"https://clinicaltrials.gov/study/NCT04214288"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["camizestrant","fulvestrant"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04214288-lancet-oncol-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04214288","phase":"2","setting":"SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer","sponsor":"AstraZeneca","started":"2020-04-22","startedType":"actual","yearReported":2023,"enrolled":240,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"AZD9833 75mg","n":74,"value":7.2,"note":"90% CI 3.7 to 10.9; Figures from the ClinicalTrials.gov results section (first posted 2023-12-12), not from a publication"},{"name":"AZD9833 150mg","n":73,"value":7.7,"note":"90% CI 5.5 to 12.9"},{"name":"AZD9833 300mg","n":20,"value":6.3,"note":"90% CI 1.9 to NA"},{"name":"Fulvestrant 500 mg","n":73,"value":3.7,"note":"90% CI 2.0 to 6.0"}],"source":"https://clinicaltrials.gov/study/NCT04214288?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"AZD9833 75mg","n":70,"value":15.7,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-12-12), not from a publication"},{"name":"AZD9833 150mg","n":65,"value":17.1},{"name":"AZD9833 300mg","n":19,"value":25.2},{"name":"Fulvestrant 500 mg","n":68,"value":11.6}],"source":"https://clinicaltrials.gov/study/NCT04214288?tab=results"}]},{"id":"nct07286331","kind":"trial","name":"A Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy (BEHOLD-Endometrial01)","aka":["BEHOLD-Endometrial01"],"tldr":"A phase 3 trial of Doxorubicin in endometrial cancer, run by GlaxoSmithKline, now recruiting.","summary":"A Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy (BEHOLD-Endometrial01) is a phase 3 interventional study registered as NCT07286331 by GlaxoSmithKline, with 600 participants planned, started 2026-06-04 and due to reach its primary completion in 2028-02-29. Interventions recorded: Mocertatug rezetecan, Paclitaxel and Doxorubicin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07286331","url":"https://clinicaltrials.gov/study/NCT07286331"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["doxorubicin"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07286331","phase":"3","setting":"A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy","sponsor":"GlaxoSmithKline","started":"2026-06-04","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07286266","kind":"trial","name":"A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01)","aka":["BEHOLD-Ovarian01"],"tldr":"A phase 3 trial of Doxorubicin, Pegylated liposomal doxorubicin, Topotecan, Gemcitabine, Pembrolizumab and Bevacizumab in ovarian cancer, run by GlaxoSmithKline, now recruiting.","summary":"A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01) is a phase 3 interventional study registered as NCT07286266 by GlaxoSmithKline, with 450 participants planned, started 2026-06-18 and due to reach its primary completion in 2029-12-17. Interventions recorded: Mocertatug rezetecan, Paclitaxel, Pegylated liposomal doxorubicin (PLD), Topotecan, Gemcitabine and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07286266","url":"https://clinicaltrials.gov/study/NCT07286266"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["doxorubicin","pegylated-liposomal-doxorubicin","topotecan","gemcitabine","pembrolizumab","bevacizumab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07286266","phase":"3","setting":"A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer","sponsor":"GlaxoSmithKline","started":"2026-06-18","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06943872","kind":"trial","name":"A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)","aka":["CELESTIAL-RRCLL"],"tldr":"A phase 3 trial of Sonrotoclax, Obinutuzumab, Rituximab and Venetoclax in chronic lymphocytic leukaemia, run by BeOne Medicines, now recruiting.","summary":"A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL) is a phase 3 interventional study registered as NCT06943872 by BeOne Medicines, with 630 participants planned, started 2025-06-11 and due to reach its primary completion in 2029-09-30. Interventions recorded: Sonrotoclax, Obinutuzumab, Rituximab and Venetoclax.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06943872","url":"https://clinicaltrials.gov/study/NCT06943872"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["sonrotoclax","obinutuzumab","rituximab","venetoclax"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06943872","phase":"3","setting":"A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","sponsor":"BeOne Medicines","started":"2025-06-11","startedType":"actual","enrolled":630,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07188558","kind":"trial","name":"A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy","aka":["PiNACLE-H2H"],"tldr":"A phase 3 trial testing Rondecabtagene autoleucel in diffuse large B-cell lymphoma and hodgkin lymphoma, now recruiting.","summary":"A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy is a phase 3 interventional study registered as NCT07188558, led by Lyell Immunopharma, and recruiting on the registry. Official title: A Phase 3 Randomised Controlled Trial of Rondecabtagene Autoleucel, an Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting. Planned enrolment is 400 participants (estimated). The study started in 2026-01-12 and primary completion is expected in 2029-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07188558","url":"https://clinicaltrials.gov/study/NCT07188558"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl","hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["rondecabtagene-autoleucel"],"companies":["lyell-immunopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07188558","phase":"3","setting":"A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel, an Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting","sponsor":"Lyell Immunopharma","started":"2026-01-12","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07129252","kind":"trial","name":"A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors","aka":["BRAVESST2"],"tldr":"A phase 1/2 trial of CRN09682 in neuroendocrine tumours, run by Crinetics Pharmaceuticals Inc., now recruiting.","summary":"A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors is a phase 1/2 interventional study registered as NCT07129252 by Crinetics Pharmaceuticals Inc., with 150 participants planned, started 2025-11-26 and due to reach its primary completion in 2027-08. Interventions recorded: CRN09682.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07129252","url":"https://clinicaltrials.gov/study/NCT07129252"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["crinetics-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07129252","phase":"1/2","setting":"A Phase 1/2 Dose Escalation Study of CRN09682 With an Expansion Phase in Participants With Progressive Metastatic Somatostatin Receptor Type 2 (SST2)-Expressing Neuroendocrine Neoplasms (NENs) and Other SST2-Expressing Solid Tumors","sponsor":"Crinetics Pharmaceuticals Inc.","started":"2025-11-26","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06634589","kind":"trial","name":"A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies","aka":[],"tldr":"A phase 1/2 trial of Sonrotoclax, Zanubrutinib, Mosunetuzumab, Glofitamab and Obinutuzumab in non-Hodgkin lymphoma, run by BeOne Medicines, now recruiting.","summary":"A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies is a phase 1/2 interventional study registered as NCT06634589 by BeOne Medicines, with 80 participants planned, started 2024-11-27 and due to reach its primary completion in 2028-12-02. Interventions recorded: Tacabrutideg, Sonrotoclax, Zanubrutinib, Mosunetuzumab, Glofitamab and Obinutuzumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06634589","url":"https://clinicaltrials.gov/study/NCT06634589"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["sonrotoclax","zanubrutinib","mosunetuzumab","glofitamab","obinutuzumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06634589","phase":"1/2","setting":"A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies","sponsor":"BeOne Medicines","started":"2024-11-27","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05801029","kind":"trial","name":"A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth","aka":["OSTARA"],"tldr":"A phase 2 trial of Osimertinib, Amivantamab in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations is a phase 2 interventional study registered as NCT05801029 by AstraZeneca, with 60 participants enrolled, started 2023-07-18 and due to reach its primary completion in 2027-10-01. Interventions recorded: Osimertinib, Amivantamab. Conditions listed: Non-Small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05801029","url":"https://clinicaltrials.gov/study/NCT05801029"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["bispecific-antibody","kinase-inhibitors"],"targets":[],"drugs":["osimertinib","amivantamab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05801029","phase":"2","setting":"A Phase II, Open-label, Single-arm, Multi-centre Study to Evaluate the Safety and Efficacy of Osimertinib With Amivantamab as First-line Treatment in Participants With Epidermal Growth Factor Receptor Mutation-Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (OSTARA)","sponsor":"AstraZeneca","started":"2023-07-18","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07055594","kind":"trial","name":"A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors","aka":["NbTAST-01"],"tldr":"A phase 1/2 trial of SOA101 in advanced solid tumours, run by Shine-On Biomedical Co., Ltd., now recruiting.","summary":"A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07055594 by Shine-On Biomedical Co., Ltd., with 76 participants planned, started 2025-07-30 and due to reach its primary completion in 2028-02. Interventions recorded: SOA101.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07055594","url":"https://clinicaltrials.gov/study/NCT07055594"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07055594","phase":"1/2","setting":"A Phase I/IIa Dose-escalation, Dose-optimization and Dose Expansion Study to Evaluate the Safety and Preliminary Efficacy of Tri-specific Antibody (SOA101) in Subjects With Advanced Solid Tumors.","sponsor":"Shine-On Biomedical Co., Ltd.","started":"2025-07-30","startedType":"actual","enrolled":76,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05081609","kind":"trial","name":"A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab, Trastuzumab, Trastuzumab emtansine in ovarian cancer and melanoma, run by Ascendis Pharma Oncology Division A/S, active and no longer recruiting.","summary":"A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies is a phase 1/2 interventional study registered as NCT05081609 by Ascendis Pharma Oncology Division A/S, with 320 participants enrolled, started 2022-01-11 and due to reach its primary completion in 2027-08. Interventions recorded: TransCon IL-2 β/γ, Pembrolizumab, Chemotherapy drug, TransCon TLR7/8 Agonist, Surgery. Conditions listed: Advanced Solid Tumor, Locally Advanced Solid Tumor, Metastatic Solid Tumor, Platinum-resistant Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05081609","url":"https://clinicaltrials.gov/study/NCT05081609"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","melanoma","cervical","nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","trastuzumab","trastuzumab-emtansine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05081609-j-immunother-cancer-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05081609","phase":"1/2","setting":"IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies","sponsor":"Ascendis Pharma Oncology Division A/S","started":"2022-01-11","startedType":"actual","enrolled":320,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07115043","kind":"trial","name":"A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Rilvegostomig in melanoma and non-small-cell lung cancer, run by AstraZeneca, now recruiting.","summary":"A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT07115043 by AstraZeneca, with 120 participants planned, started 2025-07-29 and due to reach its primary completion in 2029-10-02. Interventions recorded: AZD6750, rilvegostomig. Conditions listed: Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma (Skin), Renal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07115043","url":"https://clinicaltrials.gov/study/NCT07115043"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","nsclc","sclc","rcc","merkel-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["rilvegostomig"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07115043","phase":"1/2","setting":"A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors","sponsor":"AstraZeneca","started":"2025-07-29","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07277231","kind":"trial","name":"A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia","aka":[],"tldr":"A phase 3 trial of Sonrotoclax, Zanubrutinib, Acalabrutinib and Venetoclax in chronic lymphocytic leukaemia, run by BeOne Medicines, now recruiting.","summary":"A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia is a phase 3 interventional study registered as NCT07277231 by BeOne Medicines, with 500 participants planned, started 2026-01-22 and due to reach its primary completion in 2031-02. Interventions recorded: Sonrotoclax, Zanubrutinib, Acalabrutinib and Venetoclax.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07277231","url":"https://clinicaltrials.gov/study/NCT07277231"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["sonrotoclax","zanubrutinib","acalabrutinib","venetoclax"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07277231","phase":"3","setting":"A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia","sponsor":"BeOne Medicines","started":"2026-01-22","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06637501","kind":"trial","name":"A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia","aka":[],"tldr":"A phase 2 trial of Sonrotoclax and Zanubrutinib in chronic lymphocytic leukaemia, run by BeOne Medicines, active and no longer recruiting.","summary":"A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia is a phase 2 interventional study registered as NCT06637501 by BeOne Medicines, with 94 participants enrolled, started 2024-11-14 and due to reach its primary completion in 2026-11. Interventions recorded: Sonrotoclax and Zanubrutinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06637501","url":"https://clinicaltrials.gov/study/NCT06637501"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["sonrotoclax","zanubrutinib"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06637501","phase":"2","setting":"A Multicenter, Open-Label, Phase 2 Study to Investigate the Efficacy and Safety of Sonrotoclax Combined With Zanubrutinib Compared With Zanubrutinib Monotherapy in Adult Patients With Previously Untreated Chronic Lymphocytic Leukemia","sponsor":"BeOne Medicines","started":"2024-11-14","startedType":"actual","enrolled":94,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05704049","kind":"trial","name":"A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory","aka":["IZALCO"],"tldr":"A phase 2 trial of Isatuximab, Carfilzomib, Dexamethasone in multiple myeloma, run by Sanofi, active and no longer recruiting.","summary":"A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT05704049 by Sanofi, with 118 participants enrolled, started 2023-04-05 and due to reach its primary completion in 2025-12-22. Interventions recorded: Isatuximab, Carfilzomib, Dexamethasone, Dexamethasone IV, Montelukast. Conditions listed: Relapsed/Refractory Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05704049","url":"https://clinicaltrials.gov/study/NCT05704049"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","monoclonal-antibody"],"targets":[],"drugs":["isatuximab","carfilzomib","dexamethasone"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05704049","phase":"2","setting":"A Randomized, Phase 2, Open Label Study Evaluating Subcutaneous Administration of Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)","sponsor":"Sanofi","started":"2023-04-05","startedType":"actual","enrolled":118,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05661955","kind":"trial","name":"A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants","aka":[],"tldr":"A phase 1/2 trial of Tislelizumab in renal cell carcinoma and melanoma, run by BeiGene, active and no longer recruiting.","summary":"A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants With Select Advanced Solid Tumors. is a phase 1/2 interventional study registered as NCT05661955 by BeiGene, with 113 participants enrolled, started 2023-01-09 and due to reach its primary completion in 2025-05-27. Interventions recorded: BGB-A445, Tislelizumab. Conditions listed: Urothelial Carcinoma, Renal Cell Carcinoma, Melanoma, Non-mucosal Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05661955","url":"https://clinicaltrials.gov/study/NCT05661955"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc","melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05661955","phase":"1/2","setting":"Phase 1b/2 Study Investigating the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of the Anti-OX40 Agonist Monoclonal Antibody BGB-A445 in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Urothelial Carcinoma, Renal Cell Carcinoma, or Melanoma","sponsor":"BeiGene","started":"2023-01-09","startedType":"actual","enrolled":113,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07143604","kind":"trial","name":"A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2","aka":["GAMBIT"],"tldr":"A phase 2 trial of AZD0901 in gastric & gastro-oesophageal junction cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2 is a phase 2 interventional study registered as NCT07143604 by AstraZeneca, with 33 participants enrolled, started 2025-08-29 and due to reach its primary completion in 2026-09-28. Interventions recorded: AZD0901.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07143604","url":"https://clinicaltrials.gov/study/NCT07143604"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07143604","phase":"2","setting":"A Phase II, Multicentre, Open-label, Single-arm Study of AZD0901 Monotherapy in Second-or Later-Lines Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2","sponsor":"AstraZeneca","started":"2025-08-29","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06606847","kind":"trial","name":"A Study to Investigate the Effects of Durvalumab With Oleclumab Following Chemoradiation in Participants With Locally Advanced Unresectable Non-Small ","aka":["LADOGA"],"tldr":"A phase 2 trial of Oleclumab, Durvalumab in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study to Investigate the Effects of Durvalumab With Oleclumab Following Chemoradiation in Participants With Locally Advanced Unresectable Non-Small Cell Lung Cancer (LADOGA) is a phase 2 interventional study registered as NCT06606847 by AstraZeneca, with 30 participants enrolled, started 2024-09-24 and due to reach its primary completion in 2026-05-04. Interventions recorded: Oleclumab, Durvalumab. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06606847","url":"https://clinicaltrials.gov/study/NCT06606847"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["oleclumab","durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06606847","phase":"2","setting":"A Phase II, Open-label, Multicentre, Single-arm Study of Durvalumab Plus Oleclumab in Patients With Locally Advanced, Unresectable Non-small Cell Lung Cancer Who Have Not Progressed Following Definitive, Platinum-Based Chemoradiation Therapy (LADOGA)","sponsor":"AstraZeneca","started":"2024-09-24","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05361174","kind":"trial","name":"A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of IOV-4001 in melanoma and non-small-cell lung cancer, run by Iovance Biotherapeutics, Inc., now recruiting.","summary":"A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer is a phase 1/2 interventional study registered as NCT05361174 by Iovance Biotherapeutics, Inc., with 53 participants planned, started 2022-07-20 and due to reach its primary completion in 2027-09. Interventions recorded: IOV-4001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05361174","url":"https://clinicaltrials.gov/study/NCT05361174"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","nsclc","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["iovance"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05361174","phase":"1/2","setting":"A Phase 1/2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer","sponsor":"Iovance Biotherapeutics, Inc.","started":"2022-07-20","startedType":"actual","enrolled":53,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06417814","kind":"trial","name":"A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participan","aka":["TROPION-Lung15"],"tldr":"A phase 3 trial of Datopotamab deruxtecan, Osimertinib, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, now recruiting.","summary":"A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06417814 by AstraZeneca, with 744 participants planned, started 2024-10-04 and due to reach its primary completion in 2026-09-30. Interventions recorded: Dato-DXd, Osimertinib, Pemetrexed, Carboplatin, Cisplatin. Conditions listed: Metastatic Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06417814","url":"https://clinicaltrials.gov/study/NCT06417814"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan","osimertinib","pemetrexed","carboplatin","cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06417814","phase":"3","setting":"A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)","sponsor":"AstraZeneca","started":"2024-10-04","startedType":"actual","enrolled":744,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06256328","kind":"trial","name":"A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)","aka":[],"tldr":"A phase 2 trial of Oxaliplatin, Capecitabine and Nivolumab in gastric & gastro-oesophageal junction cancer, run by Ono Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer) is a phase 2 interventional study registered as NCT06256328 by Ono Pharmaceutical Co., Ltd., with 226 participants enrolled, started 2024-01-10 and due to reach its primary completion in 2025-10-09. Interventions recorded: ONO-4578, Oxaliplatin, Capecitabine, S-1, Nivolumab and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06256328","url":"https://clinicaltrials.gov/study/NCT06256328"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["oxaliplatin","capecitabine","nivolumab"],"companies":["deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06256328","phase":"2","setting":"A Randomized, Multicenter, Double-blind, Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab, Fluoropyrimidine-based and Platinum- Based Chemotherapy (Hereinafter Referred to as Chemotherapy) With Those of the Treatment With Placebo in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)","sponsor":"Ono Pharmaceutical Co., Ltd.","started":"2024-01-10","startedType":"actual","enrolled":226,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06742996","kind":"trial","name":"A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refrac","aka":[],"tldr":"A phase 3 trial of Sonrotoclax, Zanubrutinib in mantle cell lymphoma, run by BeOne Medicines, now recruiting.","summary":"A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL) is a phase 3 interventional study registered as NCT06742996 by BeOne Medicines, with 300 participants planned, started 2025-03-05 and due to reach its primary completion in 2028-08-31. Interventions recorded: Sonrotoclax, Zanubrutinib, Placebo. Conditions listed: Mantle Cell Lymphoma, B Cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06742996","url":"https://clinicaltrials.gov/study/NCT06742996"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["sonrotoclax","zanubrutinib"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06742996","phase":"3","setting":"A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma","sponsor":"BeOne Medicines","started":"2025-03-05","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05048797","kind":"trial","name":"A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic N","aka":["DESTINY-Lung04"],"tldr":"A phase 3 trial of Trastuzumab deruxtecan, Cisplatin, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations is a phase 3 interventional study registered as NCT05048797 by AstraZeneca, with 454 participants enrolled, started 2021-10-28 and due to reach its primary completion in 2026-06-09. Interventions recorded: Trastuzumab Deruxtecan, Cisplatin, Carboplatin, Pembrolizumab, Pemetrexed. Conditions listed: Locally Advanced or Metastatic Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05048797","url":"https://clinicaltrials.gov/study/NCT05048797"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","her2-mutant-nsclc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan","cisplatin","carboplatin","pembrolizumab","pemetrexed"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05048797","phase":"3","setting":"An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)","sponsor":"AstraZeneca","started":"2021-10-28","startedType":"actual","enrolled":454,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06008093","kind":"trial","name":"A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS","aka":["TRITON"],"tldr":"A phase 2 trial of Durvalumab, Tremelimumab, Pemetrexed, Pembrolizumab, Carboplatin and Cisplatin in non-small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS is a phase 2 interventional study registered as NCT06008093 by AstraZeneca, with 103 participants enrolled, started 2024-04-04 and due to reach its primary completion in 2026-10-23. Interventions recorded: Durvalumab, Tremelimumab, Pemetrexed, Pembrolizumab, Carboplatin and Cisplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06008093","url":"https://clinicaltrials.gov/study/NCT06008093"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab","pemetrexed","pembrolizumab","carboplatin","cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06008093","phase":"2","setting":"A Phase IIb, Randomized, Multicenter, Open-label Study to Assess the Efficacy of Durvalumab Plus Tremelimumab Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for First-line Treatment in Metastatic Non-small Cell Lung Cancer Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS (TRITON)","sponsor":"AstraZeneca","started":"2024-04-04","startedType":"actual","enrolled":103,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04002297","kind":"trial","name":"A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantl","aka":["MANGROVE"],"tldr":"A phase 3 trial of Zanubrutinib, Bendamustine, Rituximab in hodgkin lymphoma and mantle cell lymphoma, run by BeOne Medicines, active and no longer recruiting.","summary":"A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation is a phase 3 interventional study registered as NCT04002297 by BeOne Medicines, with 510 participants enrolled, started 2019-08-20 and due to reach its primary completion in 2027-03. Interventions recorded: zanubrutinib, bendamustine, rituximab. Conditions listed: Mantle Cell Lymphoma; Non-Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04002297","url":"https://clinicaltrials.gov/study/NCT04002297"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","mantle-cell-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["zanubrutinib","bendamustine","rituximab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04002297","phase":"3","setting":"A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation","sponsor":"BeOne Medicines","started":"2019-08-20","startedType":"actual","enrolled":510,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05714839","kind":"trial","name":"A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatme","aka":["DynaMMic-1"],"tldr":"A phase 1/2 trial of Belantamab mafodotin, Pomalidomide, Dexamethasone in multiple myeloma, run by GlaxoSmithKline, now recruiting.","summary":"A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments is a phase 1/2 interventional study registered as NCT05714839 by GlaxoSmithKline, with 123 participants planned, started 2023-06-14 and due to reach its primary completion in 2028-08-03. Interventions recorded: Belantamab, Belantamab mafodotin, Pomalidomide, Dexamethasone. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05714839","url":"https://clinicaltrials.gov/study/NCT05714839"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["belantamab-mafodotin","pomalidomide","dexamethasone"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05714839","phase":"1/2","setting":"A Phase 1/2 Open-label, Multicentre, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Clinical Activity of Belantamab as Monotherapy and in Combination With Other Treatments in Participants With Multiple Myeloma","sponsor":"GlaxoSmithKline","started":"2023-06-14","startedType":"actual","enrolled":123,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06940739","kind":"trial","name":"A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel","aka":[],"tldr":"A phase 1/2 trial of IOV-3001 in melanoma and uveal melanoma, run by Iovance Biotherapeutics, Inc., now recruiting.","summary":"A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel is a phase 1/2 interventional study registered as NCT06940739 by Iovance Biotherapeutics, Inc., with 42 participants planned, started 2025-03-11 and due to reach its primary completion in 2032-06. Interventions recorded: IOV-3001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06940739","url":"https://clinicaltrials.gov/study/NCT06940739"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","uveal-melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["iovance"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06940739","phase":"1/2","setting":"A Phase 1/2, Open-label Study of a Modified Interleukin-2 Fusion Protein (IOV-3001) in Participants With Previously Treated, Unresectable or Metastatic Melanoma Who Will Receive Lifileucel","sponsor":"Iovance Biotherapeutics, Inc.","started":"2025-03-11","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07213609","kind":"trial","name":"A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of GSK5460025 in colorectal cancer, run by GlaxoSmithKline, now recruiting.","summary":"A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors is a phase 1/2 interventional study registered as NCT07213609 by GlaxoSmithKline, with 47 participants planned, started 2025-10-20 and due to reach its primary completion in 2028-09-28. Interventions recorded: GSK5460025.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07213609","url":"https://clinicaltrials.gov/study/NCT07213609"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07213609","phase":"1/2","setting":"A Phase 1/2 Open-label, Multicenter Study of Oral GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Adult Participants With Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors","sponsor":"GlaxoSmithKline","started":"2025-10-20","startedType":"actual","enrolled":47,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06697184","kind":"trial","name":"A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.","aka":[],"tldr":"A phase 1/2 trial of Sonrotoclax, Zanubrutinib in mantle cell lymphoma, run by BeOne Medicines, now recruiting.","summary":"A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers. is a phase 1/2 interventional study registered as NCT06697184 by BeOne Medicines, with 258 participants planned, started 2025-01-23 and due to reach its primary completion in 2029-11-30. Interventions recorded: Sonrotoclax, Zanubrutinib. Conditions listed: Chronic Lymphocytic Leukemia, CLL, Mantle Cell Lymphoma, MCL. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06697184","url":"https://clinicaltrials.gov/study/NCT06697184"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["sonrotoclax","zanubrutinib"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06697184","phase":"1/2","setting":"A Phase 1/2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.","sponsor":"BeOne Medicines","started":"2025-01-23","startedType":"actual","enrolled":258,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05473156","kind":"trial","name":"A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies","aka":["APT-CUBE"],"tldr":"A phase 1/2 trial of AP203 in non-small-cell lung cancer, head and neck squamous cell carcinoma and oesophageal cancer, run by AP Biosciences Inc., now recruiting.","summary":"A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies is a phase 1/2 interventional study registered as NCT05473156 by AP Biosciences Inc., with 168 participants planned, started 2023-07-24 and due to reach its primary completion in 2026-12. Interventions recorded: AP203.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05473156","url":"https://clinicaltrials.gov/study/NCT05473156"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","head-and-neck","esophageal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ap-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05473156","phase":"1/2","setting":"A Phase 1/2, Open-label Study of the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies","sponsor":"AP Biosciences Inc.","started":"2023-07-24","startedType":"actual","enrolled":168,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06710847","kind":"trial","name":"A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors","aka":["SYLVER"],"tldr":"A phase 1/2 trial of GSK4418959 in colorectal cancer and endometrial cancer, run by GlaxoSmithKline, active and no longer recruiting.","summary":"A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors is a phase 1/2 interventional study registered as NCT06710847 by GlaxoSmithKline, with 14 participants enrolled, started 2024-12-13 and due to reach its primary completion in 2026-06-22. Interventions recorded: GSK4418959 and PD-1 inhibitor.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06710847","url":"https://clinicaltrials.gov/study/NCT06710847"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","endometrial","msi-high-colorectal","endometrial-mmr-deficient"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["gsk","ideaya-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06710847","phase":"1/2","setting":"A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of the Oral DNA Helicase Werner Inhibitor (WRNi) GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Adult Participants With Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors (SYLVER)","sponsor":"GlaxoSmithKline","started":"2024-12-13","startedType":"actual","enrolled":14,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06077877","kind":"trial","name":"A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Niraparib in advanced solid tumours, run by GlaxoSmithKline, active and no longer recruiting.","summary":"A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors is a phase 1/2 interventional study registered as NCT06077877 by GlaxoSmithKline, with 42 participants enrolled, started 2023-10-24 and due to reach its primary completion in 2026-06-30. Interventions recorded: GSK4524101 and Niraparib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06077877","url":"https://clinicaltrials.gov/study/NCT06077877"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["niraparib"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06077877","phase":"1/2","setting":"A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of the Oral DNA Polymerase Theta Inhibitor (POLQi) GSK4524101 and the PARP Inhibitor (PARPi) Niraparib in Adult Participants With Solid Tumors","sponsor":"GlaxoSmithKline","started":"2023-10-24","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05456191","kind":"trial","name":"A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)","aka":[],"tldr":"A phase 3 trial of Asciminib and Nilotinib in chronic myeloid leukaemia, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) is a phase 3 interventional study registered as NCT05456191 by Novartis Pharmaceuticals, with 568 participants enrolled, started 2022-11-21 and due to reach its primary completion in 2025-05-15. Interventions recorded: Asciminib and Nilotinib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05456191","url":"https://clinicaltrials.gov/study/NCT05456191"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cml","cml-chronic-phase"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["asciminib","nilotinib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05456191","phase":"3","setting":"A Phase IIIb, Multi-center, Open-label, Randomized Study of Tolerability and Efficacy of Oral Asciminib Versus Nilotinib in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase.","sponsor":"Novartis Pharmaceuticals","started":"2022-11-21","startedType":"actual","yearReported":2026,"enrolled":568,"enrolledBasis":"registry","outcomes":[{"endpoint":"Time to Discontinuation of Study Treatment Due to Adverse Event (TTDAE) (From Interim Analysis)","primary":true,"unit":"participants","arms":[{"name":"Asciminib","n":284,"value":16,"note":"Figures from the ClinicalTrials.gov results section (first posted 2026-05-27), not from a publication"},{"name":"Nilotinib","n":282,"value":34}],"hr":0.45,"ci":[0.25,0.81],"p":"0.004","source":"https://clinicaltrials.gov/study/NCT05456191?tab=results"}]},{"id":"nct07154290","kind":"trial","name":"A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)","aka":[],"tldr":"A phase 2 trial of Ubamatamab and REGN7075 in non-small-cell lung cancer, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) is a phase 2 interventional study registered as NCT07154290 by Regeneron Pharmaceuticals, with 300 participants planned, started 2026-03-18 and due to reach its primary completion in 2030-06-10. Interventions recorded: Ubamatamab, Marlotamig and Sarilumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07154290","url":"https://clinicaltrials.gov/study/NCT07154290"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["ubamatamab","regn7075"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07154290","phase":"2","setting":"A Phase 2 Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Treatment-Experienced Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Regeneron Pharmaceuticals","started":"2026-03-18","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07585266","kind":"trial","name":"A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)","aka":[],"tldr":"A phase 3 trial testing Velzatinib in gastrointestinal stromal tumour, now recruiting.","summary":"A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumours (StrateGIST Frontline) is a phase 3 interventional study registered as NCT07585266, led by GlaxoSmithKline, and recruiting on the registry. Official title: A Phase 3, Randomised, Multicenter, Open-Label Study of Velzatinib (GSK6042981) Versus Imatinib in Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumours (GIST). Planned enrolment is 800 participants (estimated). The study started in 2026-07-27 and primary completion is expected in 2032-08-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07585266","url":"https://clinicaltrials.gov/study/NCT07585266"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gist"],"sections":[],"technologies":[],"targets":[],"drugs":["velzatinib"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07585266","phase":"3","setting":"A Phase 3, Randomized, Multicenter, Open-Label Study of Velzatinib (GSK6042981) Versus Imatinib in Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST)","sponsor":"GlaxoSmithKline","started":"2026-07-27","startedType":"actual","enrolled":800,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05623020","kind":"trial","name":"A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide","aka":["MagnetisMM-6"],"tldr":"A phase 3 trial of Elranatamab, Daratumumab, Lenalidomide in multiple myeloma, run by Pfizer, now recruiting.","summary":"A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant is a phase 3 interventional study registered as NCT05623020 by Pfizer, with 1116 participants planned, started 2022-11-10 and due to reach its primary completion in 2030-10-18. Interventions recorded: Elranatamab, Daratumumab, Lenalidomide, Dexamethasone, Bortezomib. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05623020","url":"https://clinicaltrials.gov/study/NCT05623020"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-transplant-ineligible"],"sections":[],"technologies":["antiemetic-therapy","kinase-inhibitors","monoclonal-antibody","protac-degrader","t-cell-engager"],"targets":[],"drugs":["elranatamab","daratumumab","lenalidomide","dexamethasone","bortezomib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05623020","phase":"3","setting":"AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + BORTEZOMIB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA","sponsor":"Pfizer","started":"2022-11-10","startedType":"actual","enrolled":1116,"enrolledBasis":"registry","outcomes":[]},{"id":"himalayas-1","kind":"trial","name":"A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)","aka":["Himalayas-1"],"tldr":"A phase 3 trial testing Rinzimetostat in prostate cancer, now recruiting.","summary":"A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1) is a phase 3 interventional study registered as NCT07723248, led by ORIC Pharmaceuticals with Bayer, and recruiting on the registry. Official title: A Phase 3, Randomised, Open-Label Study of Rinzimetostat (ORIC-944) in Combination With Darolutamide Compared With ARPI or Docetaxel in Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Abiraterone Acetate (Himalayas-1). Planned enrolment is 600 participants (estimated). The study started in 2026-08-03 and primary completion is expected in 2028-03. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07723248","url":"https://clinicaltrials.gov/study/NCT07723248"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["rinzimetostat"],"companies":["oric-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07723248","phase":"3","setting":"A Phase 3, Randomized, Open-Label Study of Rinzimetostat (ORIC-944) in Combination With Darolutamide Compared With ARPI or Docetaxel in Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Abiraterone Acetate (Himalayas-1)","sponsor":"ORIC Pharmaceuticals","started":"2026-08-03","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06989437","kind":"trial","name":"A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue","aka":[],"tldr":"A phase 2/3 trial of ponsegromab in pancreatic ductal adenocarcinoma, run by Pfizer, now recruiting.","summary":"A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue is a phase 2/3 interventional study registered as NCT06989437 by Pfizer, with 982 participants planned, started 2025-10-03 and due to reach its primary completion in 2028-01-17. Interventions recorded: ponsegromab and placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06989437","url":"https://clinicaltrials.gov/study/NCT06989437"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["ponsegromab"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":["pancreatic-palliation-obstruction-pain-nutrition","cachexia"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 7): Addenbrooke's Cambridge, Royal Free London, Western General Edinburgh, Clatterbridge Liverpool, Guy's and St Thomas', Royal Marsden Chelsea and one more."],"nct":"NCT06989437","phase":"2/3","setting":"A Phase 2b/3, Randomized, Double-Blind Study to Investigate the Efficacy, Safety, and Tolerability of Ponsegromab (PF-06946860) Compared With Placebo Both With Background First-Line Chemotherapy in Adult Participants With Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma","sponsor":"Pfizer","started":"2025-10-03","startedType":"actual","enrolled":982,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05262400","kind":"trial","name":"A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Atirmociclib and Fulvestrant in advanced solid tumours, run by Pfizer, active and no longer recruiting.","summary":"A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors is a phase 1/2 interventional study registered as NCT05262400 by Pfizer, with 235 participants enrolled, started 2022-03-14 and due to reach its primary completion in 2027-02-26. Interventions recorded: PF-07220060 + PF-07104091 combination dose escalation, PF-07104091 + PF-07220060 + fulvestrant dose expansion and PF-07104091 + PF-07220060 + letrozole dose expansion.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05262400","url":"https://clinicaltrials.gov/study/NCT05262400"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["atirmociclib","fulvestrant"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05262400","phase":"1/2","setting":"A PHASE 1B/2, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTITUMOR ACTIVITY OF PF-07220060 IN COMBINATION WITH PF-07104091 PLUS ENDOCRINE THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS","sponsor":"Pfizer","started":"2022-03-14","startedType":"actual","enrolled":235,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07062965","kind":"trial","name":"A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment","aka":[],"tldr":"A phase 3 trial testing PF-07248144 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment is a phase 3 interventional study registered as NCT07062965, led by Pfizer, and recruiting on the registry. Official title: An Interventional, Open-Label, Randomised, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator's Choice of Therapy in Adult Participants With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy. Planned enrolment is 400 participants (estimated). The study started in 2025-08-05 and primary completion is expected in 2027-07-22. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07062965","url":"https://clinicaltrials.gov/study/NCT07062965"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-07248144"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07062965","phase":"3","setting":"An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator's Choice of Therapy in Adult Participants With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy","sponsor":"Pfizer","started":"2025-08-05","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nsclc-4","kind":"trial","name":"A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)","aka":["PADL1NK-005"],"tldr":"A phase 3 trial testing PF-08046054 in non-small-cell lung cancer, now recruiting.","summary":"A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC) is a phase 3 interventional study registered as NCT07144280, led by Pfizer, and recruiting on the registry. Official title: PADL1NK-005: A Randomised, Phase 3, Open-Label Study to Evaluate PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC). Planned enrolment is 680 participants (estimated). The study started in 2025-09-29 and primary completion is expected in 2028-03-10. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07144280","url":"https://clinicaltrials.gov/study/NCT07144280"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-08046054"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07144280","phase":"3","setting":"PADL1NK-005: A Randomized, Phase 3, Open-Label Study to Evaluate PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)","sponsor":"Pfizer","started":"2025-09-29","startedType":"actual","enrolled":680,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05020236","kind":"trial","name":"A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments","aka":["MAGNETISMM-5"],"tldr":"A phase 3 trial of Elranatamab, Daratumumab, Pomalidomide in multiple myeloma, run by Pfizer, now recruiting.","summary":"A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments is a phase 3 interventional study registered as NCT05020236 by Pfizer, with 893 participants planned, started 2021-10-04 and due to reach its primary completion in 2026-02-26. Interventions recorded: Elranatamab, Daratumumab, Pomalidomide, Dexamethasone. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05020236","url":"https://clinicaltrials.gov/study/NCT05020236"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","monoclonal-antibody","protac-degrader","t-cell-engager"],"targets":[],"drugs":["elranatamab","daratumumab","pomalidomide","dexamethasone"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05020236","phase":"3","setting":"AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR","sponsor":"Pfizer","started":"2021-10-04","startedType":"actual","enrolled":893,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06206837","kind":"trial","name":"A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer.","aka":[],"tldr":"A phase 1/2 trial of Vepdegestrant and Atirmociclib in advanced solid tumours, run by Pfizer, active and no longer recruiting.","summary":"A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer. is a phase 1/2 interventional study registered as NCT06206837 by Pfizer, with 71 participants enrolled, started 2024-02-19 and due to reach its primary completion in 2025-09-05. Interventions recorded: vepdegestrant and PF-07220060.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06206837","url":"https://clinicaltrials.gov/study/NCT06206837"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy","protac-degrader"],"targets":[],"drugs":["vepdegestrant","atirmociclib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06206837","phase":"1/2","setting":"AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH PF-07220060 IN PARTICIPANTS AGED 18 YEARS AND OLDER WITH ER+/HER2- ADVANCED OR METASTATIC BREAST CANCER","sponsor":"Pfizer","started":"2024-02-19","startedType":"actual","enrolled":71,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06629779","kind":"trial","name":"A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.","aka":["MEVPRO-2"],"tldr":"A phase 3 trial of Mevrometostat, Enzalutamide in prostate cancer, run by Pfizer, now recruiting.","summary":"A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer. is a phase 3 interventional study registered as NCT06629779 by Pfizer, with 900 participants planned, started 2024-10-22 and due to reach its primary completion in 2026-12-02. Interventions recorded: PF-06821497, Placebo, Enzalutamide. Conditions listed: Metastatic Castration-Resistant Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06629779","url":"https://clinicaltrials.gov/study/NCT06629779"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation","epigenetic-drugs"],"targets":[],"drugs":["mevrometostat","enzalutamide"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06629779","phase":"3","setting":"A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)","sponsor":"Pfizer","started":"2024-10-22","startedType":"actual","enrolled":900,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07192614","kind":"trial","name":"A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Pr","aka":["ACTIVATED-4-PC"],"tldr":"A phase 1/2 trial of AZD6621 in prostate cancer, run by AstraZeneca, now recruiting.","summary":"A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer is a phase 1/2 interventional study registered as NCT07192614 by AstraZeneca, with 52 participants planned, started 2025-09-30 and due to reach its primary completion in 2029-03-29. Interventions recorded: AZD6621. Conditions listed: Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07192614","url":"https://clinicaltrials.gov/study/NCT07192614"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["azd6621"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07192614","phase":"1/2","setting":"A Phase I/II Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6621, a T Cell-engaging Antibody That Targets STEAP2, CD3, and CD8 in Adult Participants With Metastatic Prostate Cancer","sponsor":"AstraZeneca","started":"2025-09-30","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07450599","kind":"trial","name":"A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have Hi","aka":["CHINANEO"],"tldr":"A phase 2 trial of Darolutamide in prostate cancer, run by Bayer, now recruiting.","summary":"A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer. is a phase 2 interventional study registered as NCT07450599 by Bayer, with 250 participants planned, started 2026-04-27 and due to reach its primary completion in 2028-10-15. Interventions recorded: Darolutamide, ADT. Conditions listed: High-risk Localized Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07450599","url":"https://clinicaltrials.gov/study/NCT07450599"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["darolutamide"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07450599","phase":"2","setting":"A China Interventional Phase II, Single Arm, Multicenter Study Evaluating the Effectiveness and Safety of Darolutamide + ADT as Neo-Adjuvant Treatment in Treatment-naïve Patients Who Have Planned for Radical Prostatectomy (RP) With High Risk Localized Prostate Cancer","sponsor":"Bayer","started":"2026-04-27","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05785767","kind":"trial","name":"A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small","aka":[],"tldr":"A phase 2/3 trial of Fianlimab, Cemiplimab in non-small-cell lung cancer and small-cell lung cancer, run by Regeneron Pharmaceuticals, active and no longer recruiting.","summary":"A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) is a phase 2/3 interventional study registered as NCT05785767 by Regeneron Pharmaceuticals, with 149 participants enrolled, started 2023-06-30 and due to reach its primary completion in 2027-09-28. Interventions recorded: fianlimab, cemiplimab, Placebo. Conditions listed: Advanced Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05785767","url":"https://clinicaltrials.gov/study/NCT05785767"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["fianlimab","cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05785767","phase":"2/3","setting":"A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%","sponsor":"Regeneron Pharmaceuticals","started":"2023-06-30","startedType":"actual","enrolled":149,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05587296","kind":"trial","name":"A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer","aka":["OASIS-4"],"tldr":"A phase 3 trial of Elinzanetant (BAY3427080) in HR-positive / HER2-negative breast cancer, run by Bayer, active and no longer recruiting.","summary":"A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer is a phase 3 interventional study registered as NCT05587296 by Bayer, with 474 participants enrolled, started 2022-10-14 and due to reach its primary completion in 2024-01-29. Interventions recorded: Elinzanetant (BAY3427080) and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05587296","url":"https://clinicaltrials.gov/study/NCT05587296"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05587296-n-engl-j-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05587296","phase":"3","setting":"A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Induced by Adjuvant Endocrine Therapy, Over 52 Weeks and Optionally for an Additional up to 3.5 Years in Women With Hormone-receptor Positive Breast Cancer:","sponsor":"Bayer","started":"2022-10-14","startedType":"actual","enrolled":474,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06452277","kind":"trial","name":"A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-sma","aka":["SOHO-02"],"tldr":"A phase 3 trial of Sevabertinib, Pembrolizumab, Cisplatin in non-small-cell lung cancer and small-cell lung cancer, run by Bayer, now recruiting.","summary":"A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2) is a phase 3 interventional study registered as NCT06452277 by Bayer, with 444 participants planned, started 2024-08-28 and due to reach its primary completion in 2027-10-28. Interventions recorded: Sevabertinib, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed. Conditions listed: Advanced Non-small Cell Lung Cancer, HER2 Mutation. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06452277","url":"https://clinicaltrials.gov/study/NCT06452277"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","her2-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["sevabertinib","pembrolizumab","cisplatin","carboplatin","pemetrexed"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06452277","phase":"3","setting":"A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations","sponsor":"Bayer","started":"2024-08-28","startedType":"actual","enrolled":444,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06760819","kind":"trial","name":"A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)","aka":["panSOHO"],"tldr":"A phase 2 trial of BAY2927088 in advanced solid tumours, run by Bayer, now recruiting.","summary":"A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2) is a phase 2 interventional study registered as NCT06760819 by Bayer, with 111 participants planned, started 2025-02-13 and due to reach its primary completion in 2029-02-02. Interventions recorded: BAY2927088.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06760819","url":"https://clinicaltrials.gov/study/NCT06760819"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06760819","phase":"2","setting":"A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations","sponsor":"Bayer","started":"2025-02-13","startedType":"actual","enrolled":111,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05748171","kind":"trial","name":"A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL","aka":[],"tldr":"A phase 2 trial of Inotuzumab ozogamicin in acute lymphoblastic leukaemia, run by Pfizer, now recruiting.","summary":"A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL is a phase 2 interventional study registered as NCT05748171 by Pfizer, with 100 participants planned, started 2023-05-17 and due to reach its primary completion in 2033-05-21. Interventions recorded: Inotuzumab ozogamicin and ALLR3.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05748171","url":"https://clinicaltrials.gov/study/NCT05748171"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","all-paediatric-relapsed"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["inotuzumab-ozogamicin"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05748171","phase":"2","setting":"A PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH-RISK OR VERY HIGH-RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA","sponsor":"Pfizer","started":"2023-05-17","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06174987","kind":"trial","name":"A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)","aka":[],"tldr":"A phase 3 trial of Trastuzumab deruxtecan in metastatic cancer, run by Daiichi Sankyo, now recruiting.","summary":"A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s) is a phase 3 interventional study registered as NCT06174987 by Daiichi Sankyo, with 50 participants planned, started 2024-01-05 and due to reach its primary completion in 2026-08-03. Interventions recorded: T-DXd. Conditions listed: Advanced Cancer, Metastatic Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06174987","url":"https://clinicaltrials.gov/study/NCT06174987"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06174987","phase":"3","setting":"A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)","sponsor":"Daiichi Sankyo","started":"2024-01-05","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06769698","kind":"trial","name":"A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous ","aka":[],"tldr":"A phase 2 trial of Cemiplimab, Fianlimab in head and neck squamous cell carcinoma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma is a phase 2 interventional study registered as NCT06769698 by Regeneron Pharmaceuticals, with 120 participants planned, started 2026-04-14 and due to reach its primary completion in 2028-06-04. Interventions recorded: FDC fianlimab+cemiplimab, Cemiplimab, Placebo. Conditions listed: Head and Neck Squamous Cell Carcinoma (HNSCC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06769698","url":"https://clinicaltrials.gov/study/NCT06769698"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab","fianlimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06769698","phase":"2","setting":"Phase II Randomized Study of Fianlimab Plus Cemiplimab Versus Cemiplimab Plus Placebo in First-Line Treatment of Participants With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Is Positive for PD-L1 Expression","sponsor":"Regeneron Pharmaceuticals","started":"2026-04-14","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02632305","kind":"trial","name":"A Study to See the Effects That a New Combination of the Three Drugs, Nab-paclitaxel, Gemcitabine, and Cisplatin Has on Biliary Tract Cancer","aka":["AX-CSARC"],"tldr":"A phase 2 trial of gemcitabine, cisplatin and nab-paclitaxel in gallbladder cancer and other biliary tract cancers, run by AHS Cancer Control Alberta, active and no longer recruiting.","summary":"A Study to See the Effects That a New Combination of the Three Drugs, Nab-paclitaxel, Gemcitabine, and Cisplatin Has on Biliary Tract Cancer is a phase 2 interventional study registered as NCT02632305 by AHS Cancer Control Alberta, with a registry enrolment figure of 45 participants, started 2016-07-13 and due to reach its primary completion in 2026-12. Interventions recorded: nab-paclitaxel in combination with gemcitabine + cisplatin. Conditions listed: Unresectable Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: \"1. Histologically documented locally advanced or metastatic BTC (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma) not previously treated with palliative systemic therapy or rad\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02632305","url":"https://clinicaltrials.gov/study/NCT02632305"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine","cisplatin","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02632305","phase":"2","setting":"A Multicentre, Open-label Phase II Study of Nab-paclitaxel in Combination With Gemcitabine + Cisplatin as First Line Treatment in Patients With Unresectable Biliary Tract Cancer","sponsor":"AHS Cancer Control Alberta","started":"2016-07-13","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07265674","kind":"trial","name":"A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer","aka":["Beacon-BTC"],"tldr":"A phase 3 trial of Nanvuranlat in biliary tract cancer, run by J-Pharma Co., Ltd., now recruiting.","summary":"A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer is a phase 3 interventional study registered as NCT07265674 by J-Pharma Co., Ltd., with 480 participants planned, started 2026-05-11 and due to reach its primary completion in 2027-10. Interventions recorded: Nanvuranlat.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07265674","url":"https://clinicaltrials.gov/study/NCT07265674"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07265674","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Open-label, Study Evaluating the Efficacy and Safety of Nanvuranlat in Patients With Previously Treated Advanced Biliary Tract Cancer","sponsor":"J-Pharma Co., Ltd.","started":"2026-05-11","startedType":"actual","enrolled":480,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07235293","kind":"trial","name":"A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.","aka":[],"tldr":"A phase 2 trial of Atezolizumab, Fruquintinib in colorectal cancer, run by Kahr Bio Australia Pty Ltd, now recruiting.","summary":"A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer. is a phase 2 interventional study registered as NCT07235293 by Kahr Bio Australia Pty Ltd, with 90 participants planned, started 2026-01-16 and due to reach its primary completion in 2026-09-30. Interventions recorded: DSP107 + Atezolizumab, Fruquintinib. Conditions listed: Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07235293","url":"https://clinicaltrials.gov/study/NCT07235293"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["atezolizumab","fruquintinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07235293","phase":"2","setting":"A Randomized, Open-label, Phase 2b Study to Compare the Efficacy of DSP107 in Combination With Atezolizumab Versus Fruquintinib in Patients With Advanced Microsatellite Stable Colorectal Cancer","sponsor":"Kahr Bio Australia Pty Ltd","started":"2026-01-16","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07287150","kind":"trial","name":"A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer","aka":["InavoPC"],"tldr":"A phase 2 trial of Inavolisib, Enzalutamide, Abiraterone acetate in prostate cancer, run by Hoffmann-La Roche, now recruiting.","summary":"A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer is a phase 2 interventional study registered as NCT07287150 by Hoffmann-La Roche, with 100 participants planned, started 2026-03-11 and due to reach its primary completion in 2028-03-31. Interventions recorded: Inavolisib, Enzalutamide, Abiraterone, Docetaxel. Conditions listed: Metastatic Castration-Resistant Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07287150","url":"https://clinicaltrials.gov/study/NCT07287150"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation","cytotoxic-chemotherapy","kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["inavolisib","enzalutamide","abiraterone","docetaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07287150","phase":"2","setting":"A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer","sponsor":"Hoffmann-La Roche","started":"2026-03-11","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07054190","kind":"trial","name":"A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer","aka":[],"tldr":"A phase 2 trial of Inavolisib, Ribociclib and Giredestrant in advanced solid tumours, run by Hoffmann-La Roche, now recruiting.","summary":"A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer is a phase 2 interventional study registered as NCT07054190 by Hoffmann-La Roche, with 120 participants planned, started 2025-09-09 and due to reach its primary completion in 2027-07-31. Interventions recorded: Inavolisib, Ribociclib, Letrozole and Giredestrant.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07054190","url":"https://clinicaltrials.gov/study/NCT07054190"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["inavolisib","ribociclib","giredestrant"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07054190","phase":"2","setting":"A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer","sponsor":"Hoffmann-La Roche","started":"2025-09-09","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06619509","kind":"trial","name":"A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine","aka":[],"tldr":"A phase 2 trial of Brigimadlin in advanced solid tumours, run by Boehringer Ingelheim, active and no longer recruiting.","summary":"A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine is a phase 2 interventional study registered as NCT06619509 by Boehringer Ingelheim, with 90 participants enrolled, started 2024-12-30 and due to reach its primary completion in 2030-12-30. Interventions recorded: Brigimadlin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06619509","url":"https://clinicaltrials.gov/study/NCT06619509"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["brigimadlin"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06619509","phase":"2","setting":"A Phase II, Single-arm, Open-label, Long-term Safety Rollover Trial of Oral Brigimadlin in Patients With Solid Tumours","sponsor":"Boehringer Ingelheim","started":"2024-12-30","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06885034","kind":"trial","name":"A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (EMBOLD PanGI-201)","aka":["EMBOLD PanGI-201"],"tldr":"A phase 1/2 trial of Risvutatug Rezetecan in advanced solid tumours, run by GlaxoSmithKline, now recruiting.","summary":"A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (EMBOLD PanGI-201) is a phase 1/2 interventional study registered as NCT06885034 by GlaxoSmithKline, with 451 participants planned, started 2025-06-11 and due to reach its primary completion in 2028-01-10. Interventions recorded: Risvutatug Rezetecan, Drug 1, Drug 2, Drug 3 and Drug 4.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06885034","url":"https://clinicaltrials.gov/study/NCT06885034"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06885034","phase":"1/2","setting":"A Phase1 b/2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of GSK5764227 Alone and in Combination in Participants With Previously Treated Advanced Unresectable or Metastatic Gastrointestinal Solid Tumors","sponsor":"GlaxoSmithKline","started":"2025-06-11","startedType":"actual","enrolled":451,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02637687","kind":"trial","name":"A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children","aka":["SCOUT"],"tldr":"A phase 1/2 trial of Larotrectinib in advanced solid tumours, run by Bayer, active and no longer recruiting.","summary":"A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children is a phase 1/2 interventional study registered as NCT02637687 by Bayer, with 154 participants enrolled, started 2015-12-16 and due to reach its primary completion in 2024-07-20. Interventions recorded: Larotrectinib (Vitrakvi, BAY2757556).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02637687","url":"https://clinicaltrials.gov/study/NCT02637687"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cgp","kinase-inhibitors"],"targets":[],"drugs":["larotrectinib"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02637687","phase":"1/2","setting":"A Phase 1/2 Study of the Oral TRK Inhibitor Larotrectinib in Pediatric Patients With Advanced Solid or Primary Central Nervous System Tumors","sponsor":"Bayer","started":"2015-12-16","startedType":"actual","enrolled":154,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06246916","kind":"trial","name":"A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)","aka":[],"tldr":"A phase 3 trial of Fianlimab, Cemiplimab, Nivolumab in melanoma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head) is a phase 3 interventional study registered as NCT06246916 by Regeneron Pharmaceuticals, with 560 participants planned, started 2024-09-09 and due to reach its primary completion in 2027-03-22. Interventions recorded: fianlimab, cemiplimab, relatlimab+nivolumab. Conditions listed: Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06246916","url":"https://clinicaltrials.gov/study/NCT06246916"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["fianlimab","cemiplimab","nivolumab","relatlimab-nivolumab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06246916","phase":"3","setting":"A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma","sponsor":"Regeneron Pharmaceuticals","started":"2024-09-09","startedType":"actual","enrolled":560,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06336291","kind":"trial","name":"A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence","aka":["GLIOSTELLA"],"tldr":"A phase 2 trial of L19TNF in glioma & glioblastoma, run by Philogen S.p.A., active and no longer recruiting.","summary":"A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence is a phase 2 interventional study registered as NCT06336291 by Philogen S.p.A., with 90 participants enrolled, started 2024-05-22 and due to reach its primary completion in 2026-06. Interventions recorded: L19TNF and Lomustine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06336291","url":"https://clinicaltrials.gov/study/NCT06336291"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["philogen-s-p-a"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06336291","phase":"2","setting":"A Dose Optimization Study for L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence","sponsor":"Philogen S.p.A.","started":"2024-05-22","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06057922","kind":"trial","name":"A Study YL201 in Patients With Selected Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of YL201 for Injection in advanced solid tumours, run by MediLink Therapeutics (Suzhou) Co., Ltd., active and no longer recruiting.","summary":"A Study YL201 in Patients With Selected Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06057922 by MediLink Therapeutics (Suzhou) Co., Ltd., with 990 participants enrolled, started 2023-09-22 and due to reach its primary completion in 2026-10. Interventions recorded: YL201 for Injection.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06057922","url":"https://clinicaltrials.gov/study/NCT06057922"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["yl201"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06057922","phase":"1/2","setting":"A Multicenter, Open-Label, Phase 1/2 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With Selected Advanced Solid Tumors","sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","started":"2023-09-22","startedType":"actual","enrolled":990,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07226752","kind":"trial","name":"A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China","aka":[],"tldr":"A phase 3 trial of Epcoritamab in diffuse large b-cell lymphoma, run by Genmab, active and no longer recruiting.","summary":"A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China is a phase 3 interventional study registered as NCT07226752 by Genmab, with 72 participants enrolled, started 2022-10-08 and due to reach its primary completion in 2025-10-13. Interventions recorded: Epcoritamab, Investigator's Choice Chemotherapy. Conditions listed: Diffuse Large B-Cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07226752","url":"https://clinicaltrials.gov/study/NCT07226752"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["epcoritamab"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07226752","phase":"3","setting":"A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma","sponsor":"Genmab","started":"2022-10-08","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05562830","kind":"trial","name":"A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)","aka":["KEYMAKER-U04"],"tldr":"A phase 1/2 trial of Zilovertamab vedotin and Pembrolizumab in bladder & urothelial cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A) is a phase 1/2 interventional study registered as NCT05562830 by Merck Sharp & Dohme LLC, with 48 participants planned, started 2022-11-16 and due to reach its primary completion in 2029-02-26. Interventions recorded: Zilovertamab vedotin, Pembrolizumab and MK-3120.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05562830","url":"https://clinicaltrials.gov/study/NCT05562830"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["zilovertamab-vedotin","pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05562830","phase":"1/2","setting":"A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents With or Without Pembrolizumab in Participants With PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma (KEYMAKER-U04): Substudy 04A","sponsor":"Merck Sharp & Dohme LLC","started":"2022-11-16","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07213804","kind":"trial","name":"A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer","aka":["FRAmework-01"],"tldr":"A phase 3 trial testing Sofetabart Mipitecan in ovarian cancer, now recruiting.","summary":"A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer is a phase 3 interventional study registered as NCT07213804, led by Eli Lilly and with GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT) and Asia-Pacific Gynecologic Oncology Trials, and recruiting on the registry. Official title: FRAmework-01: A Three-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer. Planned enrolment is 1630 participants (estimated). The study started in 2025-10-22 and primary completion is expected in 2028-11. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07213804","url":"https://clinicaltrials.gov/study/NCT07213804"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["sofetabart-mipitecan"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07213804","phase":"3","setting":"FRAmework-01: A Three-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer","sponsor":"Eli Lilly and","started":"2025-10-22","startedType":"actual","enrolled":1630,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02663908","kind":"trial","name":"A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease","aka":[],"tldr":"A phase 3 trial of Degarelix in Prostate cancer, run by Ferring Pharmaceuticals, recorded as terminated on the registry.","summary":"A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease is a phase 3 interventional study registered as NCT02663908 by Ferring Pharmaceuticals, with 545 participants recorded, started 2016-04-19 and due to reach its primary completion in 2021-03-29. Interventions recorded: Degarelix, Leuprolide. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Degarelix because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02663908","url":"https://clinicaltrials.gov/study/NCT02663908"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["degarelix"],"companies":["ferring"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02663908","phase":"3","setting":"A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients With Prostate Cancer and Cardiovascular Disease Receiving Degarelix (Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)","sponsor":"Ferring Pharmaceuticals","started":"2016-04-19","startedType":"actual","yearReported":2022,"enrolled":545,"enrolledBasis":"registry","outcomes":[{"endpoint":"Time From Randomization to the First Confirmed (Adjudicated) Occurrence of the Composite Major Adverse Cardiovascular Event (MACE) Endpoint; Percentage of Observed Subjects With Outcome Measure Events During the Trial","primary":true,"unit":"%","arms":[{"name":"Degarelix 240 mg/80 mg","n":275,"value":5.5,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-06-29), not from a publication"},{"name":"Leuprolide 22.5 mg","n":269,"value":4.1}],"hr":1.283,"ci":[0.589,2.794],"p":"0.5294","source":"https://clinicaltrials.gov/study/NCT02663908?tab=results"},{"endpoint":"Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial","unit":"%","arms":[{"name":"Degarelix 240 mg/80 mg","n":275,"value":8.7,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-06-29), not from a publication"},{"name":"Leuprolide 22.5 mg","n":269,"value":10}],"hr":0.887,"ci":[0.512,1.539],"p":"0.6701","source":"https://clinicaltrials.gov/study/NCT02663908?tab=results"}]},{"id":"nct07673029","kind":"trial","name":"A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial testing GQ1005 in HER2-positive breast cancer, now recruiting.","summary":"A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer is a phase 3 interventional study registered as NCT07673029, led by GeneQuantum Healthcare (Suzhou), and recruiting on the registry. Official title: A Phase III, Multicenter, Open-label, Randomised Controlled Study Comparing GQ1005 and Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and a Taxane. Planned enrolment is 228 participants (estimated). The study started in 2025-01-10 and primary completion is expected in 2027-01-09. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07673029","url":"https://clinicaltrials.gov/study/NCT07673029"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["gq1005"],"companies":["genequantum-healthcare-suzhou"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07673029","phase":"3","setting":"A Phase III, Multicenter, Open-label, Randomized Controlled Study Comparing GQ1005 and Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and a Taxane","sponsor":"GeneQuantum Healthcare (Suzhou)","started":"2025-01-10","startedType":"actual","enrolled":228,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03851640","kind":"trial","name":"A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).","aka":[],"tldr":"A phase 3 trial of HC-1119 in prostate cancer, run by Hinova Pharmaceuticals Inc., now recruiting.","summary":"A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC). is a phase 3 interventional study registered as NCT03851640 by Hinova Pharmaceuticals Inc., with 417 participants planned, started 2019-04-12 and due to reach its primary completion in 2025-09. Interventions recorded: HC-1119 and placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03851640","url":"https://clinicaltrials.gov/study/NCT03851640"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hinova-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03851640-signal-transduct-target-ther-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03851640","phase":"3","setting":"A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Failed Treatments with Abiraterone Acetate and Docetaxel.","sponsor":"Hinova Pharmaceuticals Inc.","started":"2019-04-12","startedType":"actual","enrolled":417,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07110571","kind":"trial","name":"A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer","aka":[],"tldr":"A phase 2 trial of Adebrelimab, Trastuzumab rezetecan and SHR-8068 in gastric & gastro-oesophageal junction cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer is a phase 2 interventional study registered as NCT07110571 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 200 participants planned, started 2025-08-28 and due to reach its primary completion in 2026-08. Interventions recorded: Adebrelimab Injection, SHR-A1811 for Injection, SHR-A1904 for Injection and SHR-8068 Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07110571","url":"https://clinicaltrials.gov/study/NCT07110571"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["adc","checkpoint-inhibitor","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["adebrelimab","trastuzumab-rezetecan","shr-8068"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07110571","phase":"2","setting":"A Multi-cohort, Multi-center Phase II Clinical Study of Adebrelimab in Combination With SHR-A1811/SHR-A1904 and Chemotherapy or Adebrelimab in Combination With SHR-8068 as the Treatment in Subjects With Gastric or Gastroesophageal Junction Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-08-28","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04980885","kind":"trial","name":"A Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia","aka":[],"tldr":"A phase 1/2 trial of AK117 and Azacitidine in acute myeloid leukaemia, run by Akeso, active and no longer recruiting.","summary":"A Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia is a phase 1/2 interventional study registered as NCT04980885 by Akeso, with 68 participants enrolled, started 2021-08-13 and due to reach its primary completion in 2025-09. Interventions recorded: AK117 and Azacitidine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04980885","url":"https://clinicaltrials.gov/study/NCT04980885"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":["ak117","azacitidine"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04980885","phase":"1/2","setting":"A Phase Ib/II Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia","sponsor":"Akeso","started":"2021-08-13","startedType":"actual","enrolled":68,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04503265","kind":"trial","name":"A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies","aka":[],"tldr":"A phase 1/2 trial of AMXI-5001:Dose Escalation Phase I in ovarian cancer, prostate cancer and pancreatic ductal adenocarcinoma, run by AtlasMedx, Incorporated, now recruiting.","summary":"A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies is a phase 1/2 interventional study registered as NCT04503265 by AtlasMedx, Incorporated, with 122 participants planned, started 2020-08-12 and due to reach its primary completion in 2026-08. Interventions recorded: AMXI-5001:Dose Escalation Phase I and AMXI-5001:Dose Expansion Phase II.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04503265","url":"https://clinicaltrials.gov/study/NCT04503265"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","prostate","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04503265","phase":"1/2","setting":"A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies","sponsor":"AtlasMedx, Incorporated","started":"2020-08-12","startedType":"actual","enrolled":122,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02301286","kind":"trial","name":"A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients","aka":["ASPIRIN"],"tldr":"A phase 3 trial of aspirin in colorectal cancer, run by Leiden University, active but no longer recruiting.","summary":"A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients is a phase 3, randomised interventional study registered as NCT02301286 by Leiden University, with a registry enrolment figure of 770 participants, started 2015-01 and due to reach its primary completion in 2027-12. Interventions recorded: Acetylsalicylic acid; Placebo Acetylsalicylic acid. Conditions listed: Colon Cancer; Adjuvant Therapy. Primary outcome: 5 year overall survival. Colorectal eligibility wording from the registry: \"* Patients with rectal cancer (defined as tumour within 15 cm from the anal verge)\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02301286","url":"https://clinicaltrials.gov/study/NCT02301286"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["aspirin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02301286","phase":"3","setting":"A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients","sponsor":"Leiden University","started":"2015-01","startedType":"actual","enrolled":770,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03634540","kind":"trial","name":"A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)","aka":[],"tldr":"A phase 2 trial of Belzutifan, Cabozantinib in renal cell carcinoma, run by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), active and no longer recruiting.","summary":"A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003) is a phase 2 interventional study registered as NCT03634540 by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), with 118 participants planned, started 2018-09-27 and due to reach its primary completion in 2027-02-26. Interventions recorded: Belzutifan, Cabozantinib. Conditions listed: Renal Cell Carcinoma (RCC), Clear Cell Renal Cell Carcinoma (ccRCC), Kidney Cancer, Renal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03634540","url":"https://clinicaltrials.gov/study/NCT03634540"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc","clear-cell-rcc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["belzutifan","cabozantinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03634540","phase":"2","setting":"A Phase 2 Trial of PT2977 in Combination With Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma","sponsor":"Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)","started":"2018-09-27","startedType":"actual","enrolled":118,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06632405","kind":"trial","name":"A Trial of Camrelizumab Plus Nab-paclitaxel and Levocetirizine in Metastatic or Recurrent TNBC","aka":[],"tldr":"A phase 2 trial of camrelizumab and nab-paclitaxel in triple-negative breast cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, not yet recruiting.","summary":"A Trial of Camrelizumab Plus Nab-paclitaxel and Levocetirizine in Metastatic or Recurrent TNBC is a phase 2, randomised interventional study registered as NCT06632405 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, with a registry enrolment figure of 60 participants, started 2025-04-01 and due to reach its primary completion in 2027-03-31. Interventions recorded: Camrelizumab; Nab paclitaxel; Levocetirizine Hydrochloride. Conditions listed: Breast Cancer. Triple-negative eligibility wording from the registry: \"Confirmed recurrent and metastatic triple negative breast cancer by imaging and pathology (ER negative (IHC ER positive percentage \\< 1%), PR negative (IHC PR positive percentage \\< 1%), HER2 negative (IHC -/+or IHC++but FISH/CISH -)), at least one measurable focus meeting the RECIST v1\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06632405","url":"https://clinicaltrials.gov/study/NCT06632405"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["camrelizumab","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06632405","phase":"2","setting":"Camrelizumab Plus Nab-paclitaxel and Anti-histamine Drug Levocetirizine in Metastatic or Recurrent Triple-negative Breast Cancer: a Randomized, Double-arm, Phase 2 Randomized Controlled Trial","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","started":"2025-04-01","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06679985","kind":"trial","name":"A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepat","aka":[],"tldr":"A phase 2 trial of Toripalimab, Bevacizumab in hepatocellular carcinoma, run by Coherus Oncology, Inc., active and no longer recruiting.","summary":"A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma is a phase 2 interventional study registered as NCT06679985 by Coherus Oncology, Inc., with 72 participants planned, started 2024-12-20 and due to reach its primary completion in 2027-09. Interventions recorded: Casdozokitug, Toripalimab, Bevacizumab. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06679985","url":"https://clinicaltrials.gov/study/NCT06679985"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["toripalimab","bevacizumab"],"companies":["junshi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06679985","phase":"2","setting":"A Randomized Phase 2 Study of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma","sponsor":"Coherus Oncology, Inc.","started":"2024-12-20","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06679036","kind":"trial","name":"A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients","aka":[],"tldr":"A phase 1/2 trial of HRS-8080 in advanced solid tumours, run by Shandong Suncadia Medicine Co., Ltd., now recruiting.","summary":"A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients is a phase 1/2 interventional study registered as NCT06679036 by Shandong Suncadia Medicine Co., Ltd., with 300 participants planned, started 2025-01-21 and due to reach its primary completion in 2026-10-30. Interventions recorded: HRS-2189, Fluvustat, HRS-8080, HRS-6209 and HRS-1358.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06679036","url":"https://clinicaltrials.gov/study/NCT06679036"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["hrs-8080"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06679036","phase":"1/2","setting":"An Open, Multicenter Phase Ib/II Clinical Study on the Safety, Tolerance, Pharmacokinetics, and Initial Efficacy of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Patients With Advanced Unresectable or Metastatic Breast Cancer","sponsor":"Shandong Suncadia Medicine Co., Ltd.","started":"2025-01-21","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07232849","kind":"trial","name":"A Trial of HRS-4508 Combined With Other Antitumor Therapies in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of HRS-4508 tablet in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Trial of HRS-4508 Combined With Other Antitumor Therapies in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT07232849 by Jiangsu HengRui Medicine Co., Ltd., with 100 participants planned, started 2025-12-04 and due to reach its primary completion in 2027-12. Interventions recorded: HRS-4508 tablet.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07232849","url":"https://clinicaltrials.gov/study/NCT07232849"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07232849","phase":"2","setting":"Study on Efficacy and Safety of HRS-4508 Combined With Other Antitumor Therapies in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-12-04","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07003321","kind":"trial","name":"A Trial of HRS-4508 in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of HRS-4508 tablet in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Trial of HRS-4508 in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT07003321 by Jiangsu HengRui Medicine Co., Ltd., with 120 participants planned, started 2025-09-12 and due to reach its primary completion in 2027-09. Interventions recorded: HRS-4508 tablet.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07003321","url":"https://clinicaltrials.gov/study/NCT07003321"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07003321","phase":"2","setting":"Study on Efficacy and Safety of HRS-4508 in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-09-12","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06555068","kind":"trial","name":"A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients","aka":[],"tldr":"A phase 1/2 trial of Fulvestrant and HRS-8080 in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients is a phase 1/2 interventional study registered as NCT06555068 by Jiangsu HengRui Medicine Co., Ltd., with 528 participants planned, started 2024-08-12 and due to reach its primary completion in 2027-12. Interventions recorded: HRS-6209 in Combination with Fulvestrant, HRS-6209 in Combination with HRS-1358, HRS-6209 in Combination with Letrozole, HRS-6209 in Combination with HRS-8080, HRS-6209 in Combination with HRS-9813 and Letrozole and HRS-6209 in Combination with HRS-9813 and HRS-8080.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06555068","url":"https://clinicaltrials.gov/study/NCT06555068"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["fulvestrant","hrs-8080"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06555068","phase":"1/2","setting":"An Open-Label, Multi-Center Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Patients With Advanced Unresectable or Metastatic Breast Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2024-08-12","startedType":"actual","enrolled":528,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07070349","kind":"trial","name":"A Trial of HRS-6213 in Healthy Subjects and Patients With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of HRS-6213 in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Trial of HRS-6213 in Healthy Subjects and Patients With Solid Tumors is a phase 1/2 interventional study registered as NCT07070349 by Jiangsu HengRui Medicine Co., Ltd., with 48 participants planned, started 2025-07-10 and due to reach its primary completion in 2026-01. Interventions recorded: HRS-6213.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07070349","url":"https://clinicaltrials.gov/study/NCT07070349"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07070349","phase":"1/2","setting":"A Phase I/II Clinical Study to Evaluate the Safety, Radiation Dosimetry, Pharmacokinetics, and Preliminary Diagnostic Efficacy of HRS-6213 in Healthy Subjects and Patients With Solid Tumors","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-07-10","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06925581","kind":"trial","name":"A Trial of HRS-6768 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of HRS-6768 in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Trial of HRS-6768 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06925581 by Jiangsu HengRui Medicine Co., Ltd., with 84 participants planned, started 2025-04-24 and due to reach its primary completion in 2026-04. Interventions recorded: HRS-6768.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06925581","url":"https://clinicaltrials.gov/study/NCT06925581"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06925581","phase":"1/2","setting":"A Phase I/II Clinical Trial to Evaluate the Pharmacokinetics, Radiation Dosimetry, Safety and Preliminary Efficacy of HRS-6768 in the Treatment of Patients With Advanced Solid Tumors","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-04-24","startedType":"actual","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07601048","kind":"trial","name":"A Trial of HRS-7058 in Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment","aka":[],"tldr":"A phase 3 trial of Fulzerasib, Garsorasib and Glecirasib in Non-small-cell lung cancer, run by Shandong Suncadia Medicine Co., Ltd., not yet recruiting.","summary":"A Trial of HRS-7058 in Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment is a phase 3 interventional study registered as NCT07601048 by Shandong Suncadia Medicine Co., Ltd., with 450 participants planned, started 2026-06 and due to reach its primary completion in 2028-05. Interventions recorded: HRS-7058, Fulzerasib Tablets, Garsorasib Tablets, Glecirasib Citrate Tablets. Conditions recorded: KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment.\n\nLinked to the drug Fulzerasib because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07601048","url":"https://clinicaltrials.gov/study/NCT07601048"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["fulzerasib","garsorasib","glecirasib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07601048","phase":"3","setting":"A Randomized, Open-Label, Multicenter Phase III Trial of HRS-7058 Versus the Investigator-Selected KRAS G12C Inhibitor in KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment","sponsor":"Shandong Suncadia Medicine Co., Ltd.","started":"2026-06","startedType":"estimated","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05482568","kind":"trial","name":"A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of Adebrelimab, Pyrotinib and Trastuzumab rezetecan in non-small-cell lung cancer, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT05482568 by Jiangsu HengRui Medicine Co., Ltd., with 324 participants planned, started 2022-09-15 and due to reach its primary completion in 2026-12. Interventions recorded: SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05482568","url":"https://clinicaltrials.gov/study/NCT05482568"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","her2-mutant-nsclc"],"sections":[],"technologies":["adc","checkpoint-inhibitor","kinase-inhibitors","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["adebrelimab","pyrotinib","trastuzumab-rezetecan"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05482568","phase":"1/2","setting":"Phase IB/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer With HER2","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2022-09-15","startedType":"actual","enrolled":324,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00880360","kind":"trial","name":"A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer","aka":[],"tldr":"A phase 2 trial of Denileukin diftitox in Ovarian cancer, run by The University of Texas Health Science Center at San Antonio, completed.","summary":"A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer is a phase 2 interventional study registered as NCT00880360 by The University of Texas Health Science Center at San Antonio, with 19 participants recorded, started 2007-02 and reaching its primary completion in 2010-04. Interventions recorded: Ontak. Conditions recorded: Epithelial Ovarian Cancer, Extraovarian Peritoneal Cancer, Fallopian Tube Carcinoma.\n\nLinked to the drug Denileukin diftitox because the registry names it among its interventions and Ovarian cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00880360","url":"https://clinicaltrials.gov/study/NCT00880360"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["denileukin-diftitox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00880360","phase":"2","setting":"A Phase II Trial of Intravenous Ontak to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, or Extraovarian Peritoneal Carcinoma, of Fallopian Tube Carcinoma Failing or Ineligible for First-Line Therapy","sponsor":"The University of Texas Health Science Center at San Antonio","started":"2007-02","yearReported":2012,"enrolled":19,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants Demonstrating Clinical Response","primary":true,"unit":"participants","arms":[{"name":"Ontak","n":19,"value":19,"note":"Figures from the ClinicalTrials.gov results section (first posted 2012-10-19), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00880360?tab=results"}]},{"id":"nct07281976","kind":"trial","name":"A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of Toripalimab in triple-negative breast cancer, run by Nanjing Leads Biolabs Co.,Ltd, now recruiting.","summary":"A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer is a phase 1/2 interventional study registered as NCT07281976 by Nanjing Leads Biolabs Co.,Ltd, with 220 participants planned, started 2026-01-27 and due to reach its primary completion in 2027-12-31. Interventions recorded: LBL-024 for Injection, albumin-bound Paclitaxel injection and Toripalimab Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07281976","url":"https://clinicaltrials.gov/study/NCT07281976"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":["nanjing-leads-biolabs"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07281976","phase":"1/2","setting":"An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 Monotherapy or in Combination With Albumin-bound Paclitaxel in Patients With Recurrent or Metastatic Triple Negative Breast Cancer","sponsor":"Nanjing Leads Biolabs Co.,Ltd","started":"2026-01-27","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06624644","kind":"trial","name":"A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma","aka":[],"tldr":"A phase 2/3 trial testing LNS8801 in melanoma, now recruiting.","summary":"A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma is a phase 2/3 interventional study registered as NCT06624644, led by Linnaeus Therapeutics, and recruiting on the registry. Official title: A Multicenter, Open-Label, Randomised, Controlled Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Patients With Treatment-Refractory, Unresectable Melanoma. Planned enrolment is 135 participants (estimated). The study started in 2025-08-06 and primary completion is expected in 2029-02. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06624644","url":"https://clinicaltrials.gov/study/NCT06624644"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["lns8801"],"companies":["linnaeus-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06624644","phase":"2/3","setting":"A Multicenter, Open-Label, Randomized, Controlled Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Patients With Treatment-Refractory, Unresectable Melanoma","sponsor":"Linnaeus Therapeutics","started":"2025-08-06","startedType":"actual","enrolled":135,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04965493","kind":"trial","name":"A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)","aka":["BRUIN CLL-322"],"tldr":"A phase 3 trial of Pirtobrutinib, Venetoclax and Rituximab in chronic lymphocytic leukaemia, run by Loxo Oncology, Inc., active and no longer recruiting.","summary":"A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) is a phase 3 interventional study registered as NCT04965493 by Loxo Oncology, Inc., with 600 participants enrolled, started 2021-09-20 and due to reach its primary completion in 2026-10. Interventions recorded: Pirtobrutinib, Venetoclax and Rituximab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04965493","url":"https://clinicaltrials.gov/study/NCT04965493"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["pirtobrutinib","venetoclax","rituximab"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04965493","phase":"3","setting":"A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)","sponsor":"Loxo Oncology, Inc.","started":"2021-09-20","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04316364","kind":"trial","name":"A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC","aka":[],"tldr":"A phase 3 trial of Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC is a phase 3 interventional study registered as NCT04316364 by Jiangsu HengRui Medicine Co., Ltd., with 537 participants planned, started 2020-07-14 and due to reach its primary completion in 2023-04-15. Interventions recorded: SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin, SHR-1316、Chemotherapeutic, Placebo、Chemotherapeutic. Conditions listed: Non-Small-Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04316364","url":"https://clinicaltrials.gov/study/NCT04316364"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04316364","phase":"3","setting":"A Randomized, Double-Blind, Multicenter, Phase Ib/III Clinical Study on PD-L1 Monoclonal Antibody SHR-1316 or Placebo in Combination With Chemotherapy as Perioperative Treatment of Resectable Stage II or III Non-Small Cell Lung Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2020-07-14","startedType":"actual","enrolled":537,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07028268","kind":"trial","name":"A Trial of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors","aka":[],"tldr":"A phase 2 trial of Denosumab in advanced solid tumours, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Trial of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors is a phase 2 interventional study registered as NCT07028268 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 210 participants planned, started 2025-06-24 and due to reach its primary completion in 2025-12. Interventions recorded: SHR-2017、Denosumab placebo and Denosumab；SHR-2017 placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07028268","url":"https://clinicaltrials.gov/study/NCT07028268"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["bone-modifying-agents","monoclonal-antibody"],"targets":[],"drugs":["denosumab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07028268","phase":"2","setting":"A Multicenter, Randomized, Double-Blind, Positively Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-06-24","startedType":"actual","enrolled":210,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07028281","kind":"trial","name":"A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors","aka":[],"tldr":"A phase 2 trial of Adebrelimab, Carboplatin, Cisplatin and SHR-8068 in advanced solid tumours, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors is a phase 2 interventional study registered as NCT07028281 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 120 participants planned, started 2025-07-08 and due to reach its primary completion in 2028-12. Interventions recorded: SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07028281","url":"https://clinicaltrials.gov/study/NCT07028281"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["adebrelimab","carboplatin","cisplatin","shr-8068"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07028281","phase":"2","setting":"A Multicenter, Open-label, Phase II Clinical Study of SHR-4849 Injection Combined With Other Antineoplastic Drugs in Patients With Malignant Solid Tumors","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-07-08","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07268040","kind":"trial","name":"A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors","aka":[],"tldr":"A phase 2 trial of Adebrelimab, Etoposide, Carboplatin and Cisplatin in advanced solid tumours, run by Shanghai Hengrui Pharmaceutical Co., Ltd., now recruiting.","summary":"A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors is a phase 2 interventional study registered as NCT07268040 by Shanghai Hengrui Pharmaceutical Co., Ltd., with 400 participants planned, started 2025-12-23 and due to reach its primary completion in 2028-12. Interventions recorded: SHR-7787 Injection, SHR-1316 Injection, SHR-4849 Injection, Etoposide injection, Carboplatin injection and Cisplatin injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07268040","url":"https://clinicaltrials.gov/study/NCT07268040"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["adebrelimab","etoposide","carboplatin","cisplatin"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07268040","phase":"2","setting":"A Multicenter, Open-label Phase II Clinical Study of SHR-7787 Combined With Other Antitumor Drugs in Patients With Advanced Solid Tumors","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2025-12-23","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06605222","kind":"trial","name":"A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SHR-7787 injection in advanced solid tumours, run by Shanghai Hengrui Pharmaceutical Co., Ltd., now recruiting.","summary":"A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06605222 by Shanghai Hengrui Pharmaceutical Co., Ltd., with 201 participants planned, started 2024-10-04 and due to reach its primary completion in 2026-07-31. Interventions recorded: SHR-7787 injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06605222","url":"https://clinicaltrials.gov/study/NCT06605222"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06605222","phase":"1/2","setting":"A Phase I/II, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7787 in Patients With Advanced Solid Tumors","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2024-10-04","startedType":"actual","enrolled":201,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06015048","kind":"trial","name":"A Trial of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.","aka":[],"tldr":"A phase 1/2 trial of Pyrotinib and Trastuzumab rezetecan in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Trial of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors. is a phase 1/2 interventional study registered as NCT06015048 by Jiangsu HengRui Medicine Co., Ltd., with 364 participants planned, started 2023-08-11 and due to reach its primary completion in 2026-11. Interventions recorded: SHR-A1811 combined with Pyrotinib. and SHR-A1811 combined with other antitumor therapies.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06015048","url":"https://clinicaltrials.gov/study/NCT06015048"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["pyrotinib","trastuzumab-rezetecan"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06015048","phase":"1/2","setting":"A Phase 1b/2 Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2023-08-11","startedType":"actual","enrolled":364,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07196774","kind":"trial","name":"A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer","aka":[],"tldr":"A phase 3 trial of Trastuzumab rezetecan, Docetaxel, Trastuzumab in her2-positive breast cancer, run by Jiangsu HengRui Medicine Co., Ltd., active and no longer recruiting.","summary":"A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer is a phase 3 interventional study registered as NCT07196774 by Jiangsu HengRui Medicine Co., Ltd., with 740 participants enrolled, started 2025-10-23 and due to reach its primary completion in 2027-12. Interventions recorded: SHR-A1811 for Injection, Docetaxel injection, Trastuzumab Injection, Carboplatin for Injection, Pertuzumab Injection. Conditions listed: Early-stage or Locally Advanced HER2-positive Breast Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07196774","url":"https://clinicaltrials.gov/study/NCT07196774"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy","monoclonal-antibody","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","docetaxel","trastuzumab","carboplatin","pertuzumab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07196774","phase":"3","setting":"A Randomized, Open-label, Multicenter Phase III Study of SHR-A1811 Compared to Docetaxel+Carboplatin+Trastuzumab+Pertuzumab as a Neoadjuvant Therapy for the Initial Treatment of Early-stage or Locally Advanced HER2-positive Breast Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-10-23","startedType":"actual","enrolled":740,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06654440","kind":"trial","name":"A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy","aka":[],"tldr":"A phase 2 trial of SHR-A2102 in advanced solid tumours, run by Shanghai Hengrui Pharmaceutical Co., Ltd., now recruiting.","summary":"A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy is a phase 2 interventional study registered as NCT06654440 by Shanghai Hengrui Pharmaceutical Co., Ltd., with 100 participants planned, started 2024-11-15 and due to reach its primary completion in 2025-08-31. Interventions recorded: SHR-A2102 for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06654440","url":"https://clinicaltrials.gov/study/NCT06654440"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-a2102"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06654440","phase":"2","setting":"An Open-label, Multicenter Phase II Clinical Study of SHR-A2102 for Injection in the Treatment of Advanced Gynaecological Malignancies","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2024-11-15","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07393542","kind":"trial","name":"A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma","aka":["NEC-UC2"],"tldr":"A phase 3 trial of SHR-A2102, Adebrelimab, Gemcitabine, Carboplatin and Cisplatin in bladder & urothelial cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma is a phase 3 interventional study registered as NCT07393542 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 453 participants planned, started 2026-02-12 and due to reach its primary completion in 2028-01-31. Interventions recorded: SHR-A2102 and Adebrelimab and Gemcitabine and cisplatin / carboplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07393542","url":"https://clinicaltrials.gov/study/NCT07393542"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["shr-a2102","adebrelimab","gemcitabine","carboplatin","cisplatin"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07393542","phase":"3","setting":"An Open Label, Randomized, Multicenter, Phase III Study of SHR-A2102 in Combination With Adebrelimab Versus Gemcitabine in Combination With Cisplatin/Carboplatin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (NEC-UC2)","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2026-02-12","startedType":"actual","enrolled":453,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07059221","kind":"trial","name":"A Trial of SHR-A2102 With Adebrelimab With or Without Other Anti-tumor Therapies in Recurrent/MetastaticHead and Neck Squamous Cell Carcinoma Cancer","aka":[],"tldr":"A phase 1/2 trial of SHR-A2102, Adebrelimab, Cetuximab in head and neck squamous cell carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"A Trial of SHR-A2102 With Adebrelimab With or Without Other Anti-tumor Therapies in Recurrent/MetastaticHead and Neck Squamous Cell Carcinoma Cancer is a phase 1/2 interventional study registered as NCT07059221 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 210 participants planned, started 2025-07-11 and due to reach its primary completion in 2027-03. Interventions recorded: SHR-A2102, Adebrelimab, Cetuximab, SHR-9839(sc), Carboplatin / Cisplatin. Conditions listed: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07059221","url":"https://clinicaltrials.gov/study/NCT07059221"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["shr-a2102","adebrelimab","cetuximab","carboplatin","cisplatin"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07059221","phase":"1/2","setting":"A Multicenter, Open-label Phase Ib/II Clinical Trial of SHR-A2102 Injection in Combination With Adebrelimab Injection, With or Without Other Anti-tumor Therapies, in Subjects With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-07-11","startedType":"actual","enrolled":210,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06474468","kind":"trial","name":"A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer","aka":[],"tldr":"A phase 1/2 trial of Adebrelimab, Cisplatin and SHR-A2102 in oesophageal cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd., now recruiting.","summary":"A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer is a phase 1/2 interventional study registered as NCT06474468 by Shanghai Hengrui Pharmaceutical Co., Ltd., with 148 participants planned, started 2024-06-20 and due to reach its primary completion in 2026-10. Interventions recorded: SHR-A2102；Adebrelimab；Cisplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06474468","url":"https://clinicaltrials.gov/study/NCT06474468"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["adebrelimab","cisplatin","shr-a2102"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06474468","phase":"1/2","setting":"A Phase IB /II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2024-06-20","startedType":"actual","enrolled":148,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06512051","kind":"trial","name":"A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of SHR-A2102, Adebrelimab, Cisplatin in non-small-cell lung cancer and small-cell lung cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd., now recruiting.","summary":"A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT06512051 by Shanghai Hengrui Pharmaceutical Co., Ltd., with 248 participants planned, started 2024-07-30 and due to reach its primary completion in 2026-10. Interventions recorded: SHR-A2102 for Injection, Adebrelimab Injection, Cisplatin injection, Carboplatin injection, Bevacizumab Injection. Conditions listed: Advanced or Metastatic Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06512051","url":"https://clinicaltrials.gov/study/NCT06512051"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["shr-a2102","adebrelimab","cisplatin","carboplatin","bevacizumab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06512051","phase":"1/2","setting":"A Phase IB /II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2024-07-30","startedType":"actual","enrolled":248,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06639347","kind":"trial","name":"A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma","aka":[],"tldr":"A phase 1/2 trial of SHR-A2102, Adebrelimab and SHR-8068 in bladder & urothelial cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd., now recruiting.","summary":"A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma is a phase 1/2 interventional study registered as NCT06639347 by Shanghai Hengrui Pharmaceutical Co., Ltd., with 90 participants planned, started 2024-11-04 and due to reach its primary completion in 2027-05-31. Interventions recorded: SHR-A2102, Adebrelimab injection and SHR-8068 injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06639347","url":"https://clinicaltrials.gov/study/NCT06639347"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-a2102","adebrelimab","shr-8068"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06639347","phase":"1/2","setting":"An Open Label, Multicenter, Phase Ib/Il Study to Evaluate the Safety, Tolerability, and Efficacy of SHR A2102 in Combination With Other Anti-cancer Agents in Patients With Advanced Urothelial Carcinoma","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2024-11-04","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06417554","kind":"trial","name":"A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SHR-A2102, Adebrelimab and Disitamab vedotin in advanced solid tumours, run by Shanghai Hengrui Pharmaceutical Co., Ltd., now recruiting.","summary":"A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06417554 by Shanghai Hengrui Pharmaceutical Co., Ltd., with 80 participants planned, started 2024-05-27 and due to reach its primary completion in 2031-12-31. Interventions recorded: SHR-A2102, SHR-A2102 ; Adebrelimab injection and SHR-A2102 + Disitamab Vedotin For Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06417554","url":"https://clinicaltrials.gov/study/NCT06417554"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-a2102","adebrelimab","disitamab-vedotin"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06417554","phase":"1/2","setting":"A Phase IB /II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With or Without Antitumor Therapy in Subjects With Advanced Solid Tumors","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2024-05-27","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06895928","kind":"trial","name":"A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors","aka":[],"tldr":"A phase 2 trial of SHR-A2102, Bevacizumab and Osimertinib in advanced solid tumours, run by Shanghai Hengrui Pharmaceutical Co., Ltd., now recruiting.","summary":"A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors is a phase 2 interventional study registered as NCT06895928 by Shanghai Hengrui Pharmaceutical Co., Ltd., with 400 participants planned, started 2025-03-28 and due to reach its primary completion in 2028-12. Interventions recorded: SHR-A2102, Bevacizumab Injection, Adebelimab Injection, Ametinib Mesylate Tablets and Osimertinib Mesylate Tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06895928","url":"https://clinicaltrials.gov/study/NCT06895928"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-a2102","bevacizumab","osimertinib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06895928","phase":"2","setting":"A Phase II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2025-03-28","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04950322","kind":"trial","name":"A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer","aka":[],"tldr":"A phase 3 trial of Retlirafusp alfa run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., active.","summary":"A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer is a phase 3 interventional study registered as NCT04950322 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 737 participants enrolled, started 2021-12-06. Conditions listed: Gastric or Gastroesophageal Junction Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04950322","url":"https://clinicaltrials.gov/study/NCT04950322"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["retlirafusp-alfa"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04950322","phase":"3","setting":"A Randomized, Double-Blind, Multi-Center, Phase III Clinical Study of SHR-1701 Plus Chemotherapy Versus Placebo Plus Chemotherapy as Treatment in Patients With Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2021-12-06","startedType":"actual","enrolled":737,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07203053","kind":"trial","name":"A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2","aka":["START-lung"],"tldr":"A phase 2 trial of tarlatamab in lung cancer, run by ETOP IBCSG Partners Foundation, now recruiting.","summary":"A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2 is a phase 2, interventional study registered as NCT07203053 by ETOP IBCSG Partners Foundation, with a registry enrolment figure of 48 participants, started 2026-04-15 and due to reach its primary completion in 2029-10. Interventions recorded: Tarlatamab. Conditions listed: Extensive Stage Lung Small Cell Cancer. Primary outcome: Overall survival rate at 12 months (12-month OS). Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed ES-SCLC\". Sites: France, Greece, Italy, Spain, Switzerland. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07203053","url":"https://clinicaltrials.gov/study/NCT07203053"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["bispecific-antibody","t-cell-engager"],"targets":[],"drugs":["tarlatamab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07203053","phase":"2","setting":"A Multicentre Phase II Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2","sponsor":"ETOP IBCSG Partners Foundation","started":"2026-04-15","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07497386","kind":"trial","name":"A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer","aka":[],"tldr":"A phase 2 trial of Trastuzumab, Trastuzumab rezetecan and Trastuzumab deruxtecan in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer is a phase 2 interventional study registered as NCT07497386 by Jiangsu HengRui Medicine Co., Ltd., with 150 participants planned, started 2026-04-28 and due to reach its primary completion in 2028-06. Interventions recorded: Trastuzumab Rezetecan for Injection and Trastuzumab Deruxtecan for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07497386","url":"https://clinicaltrials.gov/study/NCT07497386"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab","trastuzumab-rezetecan","trastuzumab-deruxtecan"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07497386","phase":"2","setting":"A Randomized, Open-Label, Multicenter Phase II Clinical Study of Different Doses of Trastuzumab Rezetecan for Injection or Trastuzumab Deruxtecan for Injection in the Treatment of Unresectable Locally Recurrent/Metastatic Breast Cancer With HR-Positive and HER2-Low Expression","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2026-04-28","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02346747","kind":"trial","name":"A Trial of Vigil for Participants With Ovarian Cancer","aka":["VITAL"],"tldr":"A phase 2 trial of Vigil in ovarian cancer, run by Gradalis, Inc., active and no longer recruiting.","summary":"A Trial of Vigil for Participants With Ovarian Cancer is a phase 2 interventional study registered as NCT02346747 by Gradalis, Inc., with 92 participants enrolled, started 2015-02 and due to reach its primary completion in 2028-12. Interventions recorded: Vigil.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02346747","url":"https://clinicaltrials.gov/study/NCT02346747"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02346747","phase":"2","setting":"A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects With Stage IIIb-IV Ovarian Cancer in Clinical Complete Response Following Surgery and Primary Chemotherapy","sponsor":"Gradalis, Inc.","started":"2015-02","startedType":"actual","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05050942","kind":"trial","name":"A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET","aka":["SORENTO"],"tldr":"A phase 3 trial of CAM2029 (octreotide subcutaneous depot) run by Camurus AB, active.","summary":"A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET is a phase 3 interventional study registered as NCT05050942 by Camurus AB, with 332 participants enrolled, started 2021-10-22. Conditions listed: Gastro-enteropancreatic Neuroendocrine Tumor. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05050942","url":"https://clinicaltrials.gov/study/NCT05050942"}],"tags":["ctgov-ingest"],"related":[],"cancers":["neuroendocrine","pancreatic-net","small-intestinal-net"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["cam2029"],"companies":["camurus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05050942","phase":"3","setting":"A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET","sponsor":"Camurus AB","started":"2021-10-22","startedType":"actual","enrolled":332,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06505395","kind":"trial","name":"A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)","aka":[],"tldr":"A phase 2 trial of SYHX2008 injection in pancreatic ductal adenocarcinoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., now recruiting.","summary":"A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET) is a phase 2 interventional study registered as NCT06505395 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., with 90 participants planned, started 2024-07-30 and due to reach its primary completion in 2027-08-01. Interventions recorded: SYHX2008 injection and Sandostatin LAR@.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06505395","url":"https://clinicaltrials.gov/study/NCT06505395"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06505395","phase":"2","setting":"A Phase Ⅱ Randomized, Parallel-group, Open-label, Active-controlled Trial to Assess the Efficacy, Safety and Pharmacokinetics of the Long-acting Octreotide Subcutaneous Injection (SYHX2008) Versus Octreotide Microspheres (Sandostatin LAR@) in Patients With GEP-NET","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","started":"2024-07-30","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03390686","kind":"trial","name":"A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer ","aka":[],"tldr":"A phase 3 trial of Bevacizumab, Carboplatin, Paclitaxel / nab-paclitaxel in non-small-cell lung cancer and small-cell lung cancer, run by Prestige Biopharma Limited, active and no longer recruiting.","summary":"A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients is a phase 3 interventional study registered as NCT03390686 by Prestige Biopharma Limited, with 650 participants enrolled, started 2019-11-15 and due to reach its primary completion in 2024-07-01. Interventions recorded: Bevacizumab, HD204, Carboplatin, Paclitaxel. Conditions listed: Lung Cancer, Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03390686","url":"https://clinicaltrials.gov/study/NCT03390686"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab","carboplatin","paclitaxel"],"companies":["prestige-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03390686","phase":"3","setting":"A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Patients With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer","sponsor":"Prestige Biopharma Limited","started":"2019-11-15","startedType":"actual","enrolled":650,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06545955","kind":"trial","name":"A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer","aka":["ABLE-22"],"tldr":"A phase 3 trial of Nadofaragene firadenovec, Gemcitabine, Docetaxel and Pembrolizumab in bladder & urothelial cancer, run by Ferring Pharmaceuticals, now recruiting.","summary":"A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer is a phase 3 interventional study registered as NCT06545955 by Ferring Pharmaceuticals, with 250 participants planned, started 2024-10-01 and due to reach its primary completion in 2028-06-30. Interventions recorded: Nadofaragene Firadenovec, Gemcitabine, Docetaxel and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06545955","url":"https://clinicaltrials.gov/study/NCT06545955"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["bcg-and-intravesical-therapy"],"targets":[],"drugs":["nadofaragene-firadenovec","gemcitabine","docetaxel","pembrolizumab"],"companies":["ferring"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06545955","phase":"3","setting":"A Phase 3, Randomised, Multi-center, Open Label Trial to Evaluate the Safety and Efficacy of Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade Bacillus Calmette-Guerin Therapy (BCG) Unresponsive Non-muscle Invasive Bladder Cancer (NMIBC)","sponsor":"Ferring Pharmaceuticals","started":"2024-10-01","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04396821","kind":"trial","name":"A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of FOLFOX, Gemcitabine in metastatic cancer, run by Transcenta Therapeutics (Hangzhou) Co., Ltd., active and no longer recruiting.","summary":"A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT04396821 by Transcenta Therapeutics (Hangzhou) Co., Ltd., with 150 participants planned, started 2020-05-28 and due to reach its primary completion in 2026-05-30. Interventions recorded: TST001, Nivolumab Injection [Opdivo], mFOLFOX6, Gemcitabine, Albumin-Bound Paclitaxel. Conditions listed: Advanced Cancer, Gastric Cancer, Gastroesophageal-junction Cancer, Pancreatic Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04396821","url":"https://clinicaltrials.gov/study/NCT04396821"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["folfox","gemcitabine","tst001"],"companies":["transcenta"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04396821","phase":"1/2","setting":"A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 Administered as Monotherapy or in Combination With Nivolumab or Standard of Care in Patients With Locally Advanced or Metastatic Solid Tumors","sponsor":"Transcenta Therapeutics (Hangzhou) Co., Ltd.","started":"2020-05-28","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04495296","kind":"trial","name":"A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of CAPOX, Capecitabine, Paclitaxel / nab-paclitaxel in metastatic cancer, run by Transcenta Therapeutics (Hangzhou) Co., Ltd., now recruiting.","summary":"A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT04495296 by Transcenta Therapeutics (Hangzhou) Co., Ltd., with 320 participants planned, started 2020-08-13 and due to reach its primary completion in 2026-06-25. Interventions recorded: TST001, Oxaliplatin, Capecitabine, Paclitaxel, Gemcitabine. Conditions listed: Advanced Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04495296","url":"https://clinicaltrials.gov/study/NCT04495296"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["capox","capecitabine","paclitaxel","gemcitabine","cisplatin","nivolumab","tst001"],"companies":["transcenta"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04495296","phase":"1/2","setting":"A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 - Claudin18.2 Monoclonal Antibody in the Treatment of Locally Advanced or Metastatic Solid Tumors","sponsor":"Transcenta Therapeutics (Hangzhou) Co., Ltd.","started":"2020-08-13","startedType":"actual","enrolled":320,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05277168","kind":"trial","name":"A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS","aka":[],"tldr":"A phase 1/2 trial of SHR-A1904 in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS is a phase 1/2 interventional study registered as NCT05277168 by Jiangsu HengRui Medicine Co., Ltd., with 83 participants planned, started 2022-05-30 and due to reach its primary completion in 2026-05. Interventions recorded: SHR-A1904.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05277168","url":"https://clinicaltrials.gov/study/NCT05277168"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05277168","phase":"1/2","setting":"AN OPEN-LABEL, SINGLE-ARM, MULTI-CENTER PHASE I/IIA CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2022-05-30","startedType":"actual","enrolled":83,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04626635","kind":"trial","name":"A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers","aka":["COMBINE-EGFR-1"],"tldr":"A phase 1/2 trial of REGN7075, Cemiplimab, Bevacizumab and Trifluridine/tipiracil in advanced solid tumours, run by Regeneron Pharmaceuticals, active and no longer recruiting.","summary":"A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers is a phase 1/2 interventional study registered as NCT04626635 by Regeneron Pharmaceuticals, with 548 participants enrolled, started 2020-12-21 and due to reach its primary completion in 2026-11-13. Interventions recorded: REGN7075, Cemiplimab, Platinum-based doublet chemotherapy, Bevacizumab and Trifluridine-tipiracil.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04626635","url":"https://clinicaltrials.gov/study/NCT04626635"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["regn7075","cemiplimab","bevacizumab","trifluridine-tipiracil"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04626635","phase":"1/2","setting":"A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors","sponsor":"Regeneron Pharmaceuticals","started":"2020-12-21","startedType":"actual","enrolled":548,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06149286","kind":"trial","name":"A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participant","aka":["OLYMPIA-5"],"tldr":"A phase 3 trial of Odronextamab, Lenalidomide, Rituximab in follicular lymphoma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma is a phase 3 interventional study registered as NCT06149286 by Regeneron Pharmaceuticals, with 580 participants planned, started 2023-12-28 and due to reach its primary completion in 2031-04-30. Interventions recorded: Odronextamab, Lenalidomide, Rituximab. Conditions listed: Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06149286","url":"https://clinicaltrials.gov/study/NCT06149286"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["monoclonal-antibody","protac-degrader","t-cell-engager"],"targets":[],"drugs":["odronextamab","lenalidomide","rituximab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06149286","phase":"3","setting":"A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination With Lenalidomide Versus Rituximab in Combination With Lenalidomide in Relapsed/Refractory Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)","sponsor":"Regeneron Pharmaceuticals","started":"2023-12-28","startedType":"actual","enrolled":580,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05125016","kind":"trial","name":"A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With REGN5678 for Adult Participants With Advanced Prostate Cancer","aka":[],"tldr":"A phase 1/2 trial of REGN4336 in prostate cancer, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With REGN5678 for Adult Participants With Advanced Prostate Cancer is a phase 1/2 interventional study registered as NCT05125016 by Regeneron Pharmaceuticals, with 228 participants planned, started 2021-11-30 and due to reach its primary completion in 2030-03-28. Interventions recorded: REGN4336 and REGN5678.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05125016","url":"https://clinicaltrials.gov/study/NCT05125016"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05125016","phase":"1/2","setting":"Phase 1/2 Study of REGN4336 (a PSMAxCD3 Bispecific Antibody) Administered Alone or in Combination With REGN5678 (a PSMAxCD28 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer","sponsor":"Regeneron Pharmaceuticals","started":"2021-11-30","startedType":"actual","enrolled":228,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03972657","kind":"trial","name":"A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metasta","aka":[],"tldr":"A phase 1/2 trial of Cemiplimab in prostate cancer and renal cell carcinoma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors is a phase 1/2 interventional study registered as NCT03972657 by Regeneron Pharmaceuticals, with 345 participants planned, started 2019-08-12 and due to reach its primary completion in 2027-11-15. Interventions recorded: REGN5678, Cemiplimab. Conditions listed: Metastatic Castration-Resistant Prostate Cancer (mCRPC), Clear Cell Renal Cell Carcinoma (ccRCC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03972657","url":"https://clinicaltrials.gov/study/NCT03972657"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","rcc","prostate-mcrpc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03972657","phase":"1/2","setting":"A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression","sponsor":"Regeneron Pharmaceuticals","started":"2019-08-12","startedType":"actual","enrolled":345,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06230224","kind":"trial","name":"A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell ","aka":["OLYMPIA-4"],"tldr":"A phase 3 trial of Odronextamab, Ifosfamide, Carboplatin in hodgkin lymphoma and non-hodgkin lymphoma, run by Regeneron Pharmaceuticals, active and no longer recruiting.","summary":"A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma is a phase 3 interventional study registered as NCT06230224 by Regeneron Pharmaceuticals, with 216 participants enrolled, started 2024-02-15 and due to reach its primary completion in 2028-05-29. Interventions recorded: Odronextamab, Ifosfamide, Carboplatin, Etoposide, Rituximab. Conditions listed: B-Cell Non-Hodgkin Lymphoma (B-NHL). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06230224","url":"https://clinicaltrials.gov/study/NCT06230224"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["odronextamab","ifosfamide","carboplatin","etoposide","rituximab","dexamethasone"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06230224","phase":"3","setting":"A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Versus Standard of Care Therapy in Participants With Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (OLYMPIA-4)","sponsor":"Regeneron Pharmaceuticals","started":"2024-02-15","startedType":"actual","enrolled":216,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07336446","kind":"trial","name":"A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs","aka":["ANDROMEDA"],"tldr":"A phase 1/2 trial of AZD9750, Saruparib in prostate cancer, run by AstraZeneca, now recruiting.","summary":"A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs is a phase 1/2 interventional study registered as NCT07336446 by AstraZeneca, with 300 participants planned, started 2026-01-27 and due to reach its primary completion in 2029-01-26. Interventions recorded: AZD9750, AZD5305. Conditions listed: Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07336446","url":"https://clinicaltrials.gov/study/NCT07336446"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["azd9750","saruparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07336446","phase":"1/2","setting":"A Phase I/II, Modular, Open-Label, Multi-Centre Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD9750 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Metastatic Prostate Cancer (ANDROMEDA)","sponsor":"AstraZeneca","started":"2026-01-27","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05557591","kind":"trial","name":"A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small ","aka":[],"tldr":"A phase 2 trial of Cemiplimab in non-small-cell lung cancer and small-cell lung cancer, run by Regeneron Pharmaceuticals, active and no longer recruiting.","summary":"A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1) is a phase 2 interventional study registered as NCT05557591 by Regeneron Pharmaceuticals, with 51 participants enrolled, started 2023-04-21 and due to reach its primary completion in 2028-01-26. Interventions recorded: BNT116, Cemiplimab. Conditions listed: Advanced Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05557591","url":"https://clinicaltrials.gov/study/NCT05557591"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05557591","phase":"2","setting":"A Phase 2 Study of Cemiplimab (Anti-PD-1 Antibody) in Combination With BNT116 (FixVac Lung) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%","sponsor":"Regeneron Pharmaceuticals","started":"2023-04-21","startedType":"actual","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05800015","kind":"trial","name":"A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult ","aka":[],"tldr":"A phase 2/3 trial of Fianlimab, Cemiplimab, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by Regeneron Pharmaceuticals, active and no longer recruiting.","summary":"A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer is a phase 2/3 interventional study registered as NCT05800015 by Regeneron Pharmaceuticals, with 160 participants enrolled, started 2023-08-08 and due to reach its primary completion in 2030-01-16. Interventions recorded: fianlimab, cemiplimab, Pemetrexed, Paclitaxel, Carboplatin. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05800015","url":"https://clinicaltrials.gov/study/NCT05800015"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["fianlimab","cemiplimab","pemetrexed","paclitaxel","carboplatin","cisplatin"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05800015","phase":"2/3","setting":"A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels","sponsor":"Regeneron Pharmaceuticals","started":"2023-08-08","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05730036","kind":"trial","name":"A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Re","aka":["LINKER-MM3"],"tldr":"A phase 3 trial of Linvoseltamab, Elotuzumab, Pomalidomide in multiple myeloma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT05730036 by Regeneron Pharmaceuticals, with 410 participants planned, started 2023-09-18 and due to reach its primary completion in 2033-04-19. Interventions recorded: Linvoseltamab, Elotuzumab, Pomalidomide, Dexamethasone. Conditions listed: Relapsed Refractory Multiple Myeloma (RRMM). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05730036","url":"https://clinicaltrials.gov/study/NCT05730036"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","monoclonal-antibody","protac-degrader","t-cell-engager"],"targets":[],"drugs":["linvoseltamab","elotuzumab","pomalidomide","dexamethasone"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05730036","phase":"3","setting":"An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)","sponsor":"Regeneron Pharmaceuticals","started":"2023-09-18","startedType":"actual","enrolled":410,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06190951","kind":"trial","name":"A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma","aka":[],"tldr":"A phase 2 trial of Cemiplimab, Fianlimab in melanoma, run by Regeneron Pharmaceuticals, active and no longer recruiting.","summary":"A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma is a phase 2 interventional study registered as NCT06190951 by Regeneron Pharmaceuticals, with 151 participants enrolled, started 2024-09-18 and due to reach its primary completion in 2026-11-02. Interventions recorded: cemiplimab, Fixed Dose Combination (FDC) cemiplimab+fianlimab, Placebo. Conditions listed: Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06190951","url":"https://clinicaltrials.gov/study/NCT06190951"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab","fianlimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06190951","phase":"2","setting":"A Phase 2 Peri-operative Trial of Fianlimab and Cemiplimab Compared With Anti-PD1 Alone in Patients With Resectable Stage III and IV Melanoma","sponsor":"Regeneron Pharmaceuticals","started":"2024-09-18","startedType":"actual","enrolled":151,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06097364","kind":"trial","name":"A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemo","aka":["OLYMPIA-2"],"tldr":"A phase 3 trial of Odronextamab, Rituximab, Cyclophosphamide in follicular lymphoma, run by Regeneron Pharmaceuticals, active and no longer recruiting.","summary":"A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma is a phase 3 interventional study registered as NCT06097364 by Regeneron Pharmaceuticals, with 733 participants planned, started 2023-11-14 and due to reach its primary completion in 2029-07-29. Interventions recorded: Odronextamab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine. Conditions listed: Follicular Lymphoma (FL). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06097364","url":"https://clinicaltrials.gov/study/NCT06097364"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["monoclonal-antibody","t-cell-engager"],"targets":[],"drugs":["odronextamab","rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06097364","phase":"3","setting":"A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-2)","sponsor":"Regeneron Pharmaceuticals","started":"2023-11-14","startedType":"actual","enrolled":733,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06091254","kind":"trial","name":"A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy ","aka":["OLYMPIA-1"],"tldr":"A phase 3 trial of Odronextamab, Rituximab, Cyclophosphamide in follicular lymphoma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma is a phase 3 interventional study registered as NCT06091254 by Regeneron Pharmaceuticals, with 822 participants planned, started 2023-12-12 and due to reach its primary completion in 2028-02-07. Interventions recorded: Odronextamab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine. Conditions listed: Follicular Lymphoma (FL). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06091254","url":"https://clinicaltrials.gov/study/NCT06091254"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["monoclonal-antibody","t-cell-engager"],"targets":[],"drugs":["odronextamab","rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06091254","phase":"3","setting":"A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)","sponsor":"Regeneron Pharmaceuticals","started":"2023-12-12","startedType":"actual","enrolled":822,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06161441","kind":"trial","name":"A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemoth","aka":[],"tldr":"A phase 2 trial of Fianlimab, Cemiplimab, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by Regeneron Pharmaceuticals, active and no longer recruiting.","summary":"A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery is a phase 2 interventional study registered as NCT06161441 by Regeneron Pharmaceuticals, with 195 participants enrolled, started 2024-07-16 and due to reach its primary completion in 2026-08-24. Interventions recorded: Fianlimab, Cemiplimab, Pemetrexed, Paclitaxel, Carboplatin. Conditions listed: Resectable Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06161441","url":"https://clinicaltrials.gov/study/NCT06161441"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["fianlimab","cemiplimab","pemetrexed","paclitaxel","carboplatin","cisplatin"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06161441","phase":"2","setting":"A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC","sponsor":"Regeneron Pharmaceuticals","started":"2024-07-16","startedType":"actual","enrolled":195,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05608291","kind":"trial","name":"A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back Af","aka":[],"tldr":"A phase 3 trial of Fianlimab, Cemiplimab, Pembrolizumab in melanoma, run by Regeneron Pharmaceuticals, active and no longer recruiting.","summary":"A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery is a phase 3 interventional study registered as NCT05608291 by Regeneron Pharmaceuticals, with 1564 participants enrolled, started 2023-01-16 and due to reach its primary completion in 2026-07-27. Interventions recorded: Fianlimab, Cemiplimab, Pembrolizumab, Placebo. Conditions listed: Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05608291","url":"https://clinicaltrials.gov/study/NCT05608291"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["fianlimab","cemiplimab","pembrolizumab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05608291","phase":"3","setting":"A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma","sponsor":"Regeneron Pharmaceuticals","started":"2023-01-16","startedType":"actual","enrolled":1564,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07455851","kind":"trial","name":"A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma","aka":[],"tldr":"A phase 1/2 trial of Linvoseltamab in multiple myeloma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT07455851 by Regeneron Pharmaceuticals, with 150 participants planned, started 2026-03-26 and due to reach its primary completion in 2033-09-30. Interventions recorded: Linvoseltamab, REGN17372+Linvoseltamab. Conditions listed: Relapsed Refractory Multiple Myeloma (RRMM). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07455851","url":"https://clinicaltrials.gov/study/NCT07455851"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["linvoseltamab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07455851","phase":"1/2","setting":"A FIH Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN17372, an Anti-GPRC5D x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma","sponsor":"Regeneron Pharmaceuticals","started":"2026-03-26","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06040099","kind":"trial","name":"A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepat","aka":["EMERALD-Y90"],"tldr":"A phase 2 trial of Durvalumab, Bevacizumab in hepatocellular carcinoma, run by AstraZeneca, active and no longer recruiting.","summary":"A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE is a phase 2 interventional study registered as NCT06040099 by AstraZeneca, with 58 participants enrolled, started 2024-02-13 and due to reach its primary completion in 2026-07-01. Interventions recorded: Durvalumab, Bevacizumab, Transarterial Radioembolization (TARE). Conditions listed: Hepatocellular Carcinoma (HCC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06040099","url":"https://clinicaltrials.gov/study/NCT06040099"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["durvalumab","bevacizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06040099","phase":"2","setting":"Phase II Single-Arm Study of Durvalumab and Bevacizumab Following Transarterial Radioembolization Using Yttrium-90 Glass Microspheres (TheraSphere™) in Unresectable Hepatocellular Carcinoma Amenable to Locoregional Therapy","sponsor":"AstraZeneca","started":"2024-02-13","startedType":"actual","enrolled":58,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07721259","kind":"trial","name":"A Vaccine (STEMVAC) for Improving Survival in Patients With Triple-Negative Breast Cancer and Moderate or Extensive Residual Cancer Burden","aka":["STEMVAC"],"tldr":"A phase 2 trial in triple-negative breast cancer, run by University of Washington, not yet recruiting.","summary":"A Vaccine (STEMVAC) for Improving Survival in Patients With Triple-Negative Breast Cancer and Moderate or Extensive Residual Cancer Burden is a phase 2, randomised interventional study registered as NCT07721259 by University of Washington, with a registry enrolment figure of 60 participants, started 2026-09-30 and due to reach its primary completion in 2029-07-16. Interventions recorded: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine; Recombinant Granulocyte-Macrophage Colony-Stimulating Factor; Biospecimen Collection. Conditions listed: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Triple-Negative Breast Carcinoma. Triple-negative eligibility wording from the registry: \"* Triple-negative breast cancer as determined by the treating oncologist\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07721259","url":"https://clinicaltrials.gov/study/NCT07721259"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07721259","phase":"2","setting":"A Multiantigen Vaccine (STEMVAC) for Adjuvant Treatment of Patients With Moderate or Extensive Residual Triple-Negative Breast Cancer","sponsor":"University of Washington","started":"2026-09-30","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05828511","kind":"trial","name":"A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnose","aka":["LINKER-MM4"],"tldr":"A phase 1/2 trial of Linvoseltamab in multiple myeloma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment is a phase 1/2 interventional study registered as NCT05828511 by Regeneron Pharmaceuticals, with 149 participants planned, started 2023-12-19 and due to reach its primary completion in 2035-11-02. Interventions recorded: Linvoseltamab. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05828511","url":"https://clinicaltrials.gov/study/NCT05828511"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["linvoseltamab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05828511","phase":"1/2","setting":"Phase 1/2 Study of Linvoseltamab (Anti-BCMA X Anti-CD3 Bispecific Antibody) in Previously Untreated Patients With Symptomatic Multiple Myeloma","sponsor":"Regeneron Pharmaceuticals","started":"2023-12-19","startedType":"actual","enrolled":149,"enrolledBasis":"registry","outcomes":[]},{"id":"a-brave","kind":"trial","name":"A-BRAVE","aka":["A-Brave"],"tldr":"A-BRAVE tested a year of the immunotherapy avelumab after standard treatment for high-risk triple-negative breast cancer at Italian and eight British hospitals. Relapse-free survival, the main endpoint, was not significantly improved; a later analysis found the benefit concentrated in tumours rich in immune cells.","summary":"A-BRAVE (NCT02926196) randomised 466 patients (474 registered) with high-risk early triple-negative breast cancer to one year of adjuvant avelumab or observation after standard therapy, in two strata: stratum A after primary surgery and adjuvant chemotherapy (high risk by pathological stage) and stratum B after neoadjuvant chemotherapy without pathological complete response. The co-primary endpoints were disease-free survival overall and in PD-L1-positive patients; the trial did not reach significance for disease-free survival in its 2024 presentation, with a numerical overall survival advantage. The biomarker analysis (Clinical Cancer Research 2026, 387 patients with baseline TILs and 330 with TILs in residual disease) found that higher baseline and residual-disease TILs were independently prognostic, that residual cancer burden was prognostic but did not predict avelumab benefit, and that avelumab improved outcomes only in tumours with baseline TILs of 30 percent or more: in stratum B three-year distant disease-free survival 92.0 versus 58.7 percent (hazard ratio 0.20) in TIL-high against 70.4 versus 70.1 percent (0.92) in TIL-low tumours (interaction p 0.019). Eight UK hospitals recruited. The primary paper's figures are not indexed on Europe PMC, so the disease-free survival hazard ratio is not quoted here.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02926196","url":"https://clinicaltrials.gov/study/NCT02926196"},{"label":"Dieci et al., Clinical Cancer Research 2026: TILs as a predictor of adjuvant avelumab efficacy in A-BRAVE","url":"https://doi.org/10.1158/1078-0432.CCR-26-0975"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["avelumab"],"companies":[],"institutions":[],"pathways":[],"terms":["tils","rcb","efs"],"trials":["impassion030","swog-s1418","keynote-522"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 8): Royal United Hospitals Bath, Blackpool Teaching Hospital, Raigmore Hospital Inverness, Royal Free Hospital, St Bartholomew's Hospital, Mount Vernon Cancer Centre, Nottingham City Hospital, Southampton General Hospital."],"nct":"NCT02926196","phase":"3","setting":"High-risk early triple-negative breast cancer after surgery and chemotherapy (adjuvant stratum, or residual disease after neoadjuvant chemotherapy): one year of adjuvant avelumab versus observation, Italy and the United Kingdom","sponsor":"Istituto Oncologico Veneto IRCCS / University of Padova","result":"Primary DFS endpoint not met (figures not indexed); exploratory: avelumab benefit only with baseline TILs 30% or more (stratum B 3-year DDFS 92.0% vs 58.7%, HR 0.20; interaction p 0.019).","started":"2016-06-17","startedType":"actual","yearReported":2024,"enrolled":474,"enrolledBasis":"registry","outcomes":[{"endpoint":"Distant disease-free survival at 3 years, stratum B, baseline TILs 30 percent or more (exploratory)","unit":"%","arms":[{"name":"Avelumab","value":92},{"name":"Observation","value":58.7}],"hr":0.2,"p":"interaction 0.019 (TIL-low tumours 70.4 versus 70.1 percent, hazard ratio 0.92)","source":"https://doi.org/10.1158/1078-0432.CCR-26-0975"}],"replication":"ALEXANDRA/IMpassion030 (adjuvant atezolizumab) was negative; the TIL interaction awaits validation."},{"id":"aall0232","kind":"trial","name":"AALL0232","aka":["COG AALL0232"],"tldr":"AALL0232 showed that giving children with high-risk acute lymphoblastic leukaemia high doses of methotrexate with leucovorin rescue cured more of them than the older escalating schedule, and that the steroid dexamethasone helped children under ten but caused bone damage without benefit in older patients.","summary":"AALL0232 was the Children's Oncology Group phase 3 trial for high-risk B-cell acute lymphoblastic leukaemia, enrolling 3,154 patients aged 1 to 30 between 2004 and 2011, of whom 2,914 were randomised in a 2 by 2 design: dexamethasone for 14 days or prednisone for 28 days during induction, and high-dose methotrexate with leucovorin rescue or Capizzi escalating-dose methotrexate with pegaspargase during the first interim maintenance.\n\nInterim monitoring showed the superiority of high-dose methotrexate and stopped enrolment in January 2011. Mature five-year event-free survival was 79.6 percent with high-dose methotrexate against 75.2 percent with Capizzi methotrexate, with fewer marrow and central nervous system relapses and no increase in acute toxicity. Children aged 1 to 9 given dexamethasone and high-dose methotrexate did best, while patients aged 10 and over gained nothing from dexamethasone and had more osteonecrosis. High-dose methotrexate became the standard for high-risk childhood disease, which is how the corpus's high-risk childhood leukaemia page cites the trial.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00075725","url":"https://clinicaltrials.gov/study/NCT00075725"}],"tags":["soc-trials"],"related":[],"cancers":["all-paediatric-high-risk","all-leukemia","leukaemia"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["methotrexate","dexamethasone","prednisone","asparaginase"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-aall0232-larsen-jco-2016"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00075725","phase":"3","setting":"Newly diagnosed high-risk B-cell acute lymphoblastic leukaemia in patients aged 1 to 30: a 2 by 2 randomisation of dexamethasone or prednisone during induction and high-dose methotrexate or Capizzi escalating methotrexate with pegaspargase during interim maintenance","sponsor":"Children's Oncology Group","result":"Five-year event-free survival 79.6 percent with high-dose methotrexate against 75.2 percent with Capizzi methotrexate; dexamethasone benefited children aged 1 to 9 (five-year event-free survival 91.2 percent with high-dose methotrexate) but not older patients.","started":"2003-12-29","startedType":"actual","yearReported":2016,"enrolled":3154,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 5 years, methotrexate randomisation (mature data)","primary":true,"unit":"%","arms":[{"name":"High-dose methotrexate with leucovorin rescue","value":79.6},{"name":"Capizzi escalating methotrexate with pegaspargase","value":75.2}],"p":"0.008","source":"https://doi.org/10.1200/JCO.2015.62.4544"},{"endpoint":"Event-free survival at 5 years, patients aged 1 to 9 by regimen","unit":"%","arms":[{"name":"Dexamethasone + high-dose methotrexate","value":91.2},{"name":"Dexamethasone + Capizzi methotrexate","value":83.2},{"name":"Prednisone + high-dose methotrexate","value":80.8},{"name":"Prednisone + Capizzi methotrexate","value":82.1}],"p":"0.015","source":"https://doi.org/10.1200/JCO.2015.62.4544"},{"endpoint":"Event-free survival at 5 years, patients aged 10 and over (registry results)","unit":"%","arms":[{"name":"Dexamethasone + high-dose methotrexate","value":77},{"name":"Dexamethasone + Capizzi methotrexate","value":69.1},{"name":"Prednisone + high-dose methotrexate","value":75.8},{"name":"Prednisone + Capizzi methotrexate","value":73.5}],"source":"https://clinicaltrials.gov/study/NCT00075725?tab=results"}]},{"id":"aall1231","kind":"trial","name":"AALL1231","aka":["COG AALL1231"],"tldr":"AALL1231 tried to improve treatment for T-cell leukaemia and lymphoma in children by adding bortezomib and by dropping routine radiotherapy to the brain; bortezomib clearly helped the lymphoma patients but not the whole group, and more than nine in ten children were spared cranial radiotherapy without more relapses.","summary":"AALL1231 was the Children's Oncology Group phase 3 trial for newly diagnosed T-cell acute lymphoblastic leukaemia and T-lymphoblastic lymphoma. 824 eligible patients enrolled between 2014 and 2017 were randomised to a modified augmented Berlin-Frankfurt-Munster regimen with or without bortezomib during induction and delayed intensification. The backbone used dexamethasone in place of prednisone and added two pegaspargase doses so that prophylactic cranial radiotherapy could be omitted in most patients (only 9.5 percent were scheduled to receive it, against 90.8 percent in the predecessor AALL0434).\n\nFour-year event-free survival was 80.1 percent without bortezomib and 83.8 percent with it, not a significant difference, and overall survival followed the same pattern. Patients with T-lymphoblastic lymphoma did significantly better with bortezomib (four-year event-free survival 86.4 against 76.5 percent, overall survival 89.5 against 78.3 percent) with no excess toxicity. Comparison with AALL0434 patients who had cranial radiotherapy showed no difference in event-free or overall survival, so the trial is cited as the evidence that cranial irradiation can be limited to central nervous system involvement and the highest-risk patients.","status":"mixed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02112916","url":"https://clinicaltrials.gov/study/NCT02112916"}],"tags":["soc-trials"],"related":[],"cancers":["all-paediatric-high-risk","all-leukemia","leukaemia"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["bortezomib","dexamethasone","asparaginase","thioguanine"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-aall1231-bortezomib-t-all-teachey-jco-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02112916","phase":"3","setting":"Newly diagnosed T-cell acute lymphoblastic leukaemia and stage II to IV T-lymphoblastic lymphoma in children and young adults: a modified augmented BFM regimen with or without bortezomib during induction and delayed intensification, with prophylactic cranial radiotherapy removed for most patients","sponsor":"National Cancer Institute (NCI)","result":"Bortezomib did not significantly improve four-year event-free survival for the whole group (83.8 against 80.1 percent) but did for T-lymphoblastic lymphoma; cranial radiotherapy was removed for more than 90 percent of patients without excess relapse.","started":"2014-10-04","startedType":"actual","yearReported":2022,"enrolled":847,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 4 years, all randomised patients","primary":true,"unit":"%","arms":[{"name":"Modified augmented BFM + bortezomib","value":83.8},{"name":"Modified augmented BFM","value":80.1}],"p":"0.131","source":"https://doi.org/10.1200/jco.21.02678"},{"endpoint":"Overall survival at 4 years, all randomised patients","unit":"%","arms":[{"name":"Modified augmented BFM + bortezomib","value":88.3},{"name":"Modified augmented BFM","value":85.7}],"p":"0.085","source":"https://doi.org/10.1200/jco.21.02678"},{"endpoint":"Event-free survival at 4 years, T-lymphoblastic lymphoma","unit":"%","arms":[{"name":"Modified augmented BFM + bortezomib","value":86.4},{"name":"Modified augmented BFM","value":76.5}],"p":"0.041","source":"https://doi.org/10.1200/jco.21.02678"},{"endpoint":"Overall survival at 4 years, T-lymphoblastic lymphoma","unit":"%","arms":[{"name":"Modified augmented BFM + bortezomib","value":89.5},{"name":"Modified augmented BFM","value":78.3}],"p":"0.009","source":"https://doi.org/10.1200/jco.21.02678"},{"endpoint":"Event-free survival at 3 years, all randomised patients (registry results)","unit":"%","arms":[{"name":"Modified augmented BFM + bortezomib","value":85.1},{"name":"Modified augmented BFM","value":81.7}],"hr":0.782,"ci":[0.561,1.091],"p":"0.074","source":"https://clinicaltrials.gov/study/NCT02112916?tab=results"}]},{"id":"aall1331","kind":"trial","name":"AALL1331","aka":["COG AALL1331"],"tldr":"AALL1331 tested swapping blocks of harsh chemotherapy for the antibody blinatumomab in children whose leukaemia had come back; the antibody caused far fewer serious infections, more patients survived in the higher-risk group, and children whose relapse was in the bone marrow did better in the low-risk group too.","summary":"AALL1331 was a Children's Oncology Group phase 3 trial at 155 hospitals in the United States, Canada, Australia and New Zealand. All 669 patients received a four-week reinduction block and were then stratified. High- and intermediate-risk patients were randomised to two cycles of blinatumomab or two cycles of multi-agent chemotherapy, each followed by transplant. Low-risk patients were randomised to standard chemotherapy or chemotherapy with three blinatumomab blocks in place of some chemotherapy cycles. The primary endpoint in each stratum was disease-free survival.\n\nIn the high- and intermediate-risk randomisation, closed early on the monitoring committee's advice, two-year disease-free survival was 54.4 percent with blinatumomab against 39.0 percent with chemotherapy, a difference that did not reach the trial's threshold, while two-year overall survival was 71.3 against 58.4 percent and serious infections, sepsis and mucositis were far less common with blinatumomab. In the low-risk stratum the overall difference was not significant, but the two thirds of patients whose relapse involved the bone marrow had better disease-free and overall survival with blinatumomab, and the authors describe that as a new standard for them.","status":"mixed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02101853","url":"https://clinicaltrials.gov/study/NCT02101853"}],"tags":["soc-trials"],"related":[],"cancers":["all-paediatric-relapsed","all-leukemia","leukaemia"],"sections":[],"technologies":["t-cell-engager","bispecific-antibody"],"targets":[],"drugs":["blinatumomab","thioguanine"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-aall1331-brown-jama-2021","paper-aall1331-low-risk-hogan-jco-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02101853","phase":"3","setting":"Children, adolescents and young adults aged 1 to 30 with a first relapse of B-cell acute lymphoblastic leukaemia: after one block of reinduction chemotherapy, blinatumomab in place of intensive consolidation chemotherapy (high and intermediate risk, then transplant) or intercalated with chemotherapy (low risk)","sponsor":"National Cancer Institute (NCI)","result":"Blinatumomab consolidation gave two-year disease-free survival of 54.4 percent against 39.0 percent with chemotherapy in high- and intermediate-risk relapse (not statistically significant after early closure), with better overall survival and far less toxicity; in low-risk bone marrow relapse it improved disease-free and overall survival.","started":"2014-12-17","startedType":"actual","yearReported":2021,"enrolled":669,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 2 years, high- and intermediate-risk relapse","primary":true,"unit":"%","arms":[{"name":"Blinatumomab consolidation then transplant","n":105,"value":54.4},{"name":"Chemotherapy consolidation then transplant","n":103,"value":39}],"hr":0.7,"ci":[0.47,1.03],"p":"0.03 (one-sided)","source":"https://doi.org/10.1001/jama.2021.0669"},{"endpoint":"Overall survival at 2 years, high- and intermediate-risk relapse","unit":"%","arms":[{"name":"Blinatumomab consolidation then transplant","n":105,"value":71.3},{"name":"Chemotherapy consolidation then transplant","n":103,"value":58.4}],"hr":0.62,"ci":[0.39,0.98],"p":"0.02 (one-sided)","source":"https://doi.org/10.1001/jama.2021.0669"},{"endpoint":"Serious infection as an adverse event, high- and intermediate-risk relapse","unit":"%","arms":[{"name":"Blinatumomab consolidation then transplant","value":15},{"name":"Chemotherapy consolidation then transplant","value":65}],"source":"https://doi.org/10.1001/jama.2021.0669"},{"endpoint":"Disease-free survival at 4 years, low-risk relapse","primary":true,"unit":"%","arms":[{"name":"Chemotherapy with blinatumomab blocks","value":61.2},{"name":"Chemotherapy alone","value":49.5}],"p":"0.089","source":"https://doi.org/10.1200/jco.22.02200"},{"endpoint":"Overall survival at 4 years, low-risk relapse","unit":"%","arms":[{"name":"Chemotherapy with blinatumomab blocks","value":90.4},{"name":"Chemotherapy alone","value":79.6}],"p":"0.11","source":"https://doi.org/10.1200/jco.22.02200"},{"endpoint":"Disease-free survival at 4 years, low-risk relapse involving the bone marrow","unit":"%","arms":[{"name":"Chemotherapy with blinatumomab blocks","value":72.7,"note":"174 patients with marrow relapse across both arms"},{"name":"Chemotherapy alone","value":53.7}],"p":"0.015","source":"https://doi.org/10.1200/jco.22.02200"}]},{"id":"aall1521","kind":"trial","name":"AALL1521","aka":["COG AALL1521","INCB 18424-269"],"tldr":"AALL1521 is the trial that added the JAK-blocking pill ruxolitinib to chemotherapy for children whose leukaemia looks like Philadelphia-positive disease but is driven by JAK signalling; it has finished treating patients and the survival results are awaited.","summary":"AALL1521 is a single-arm phase 2 study run by Incyte with the Children's Oncology Group in children and young adults with newly diagnosed high-risk B-cell acute lymphoblastic leukaemia that is Philadelphia chromosome-like with a CRLF2 rearrangement or a JAK pathway mutation, or with other JAK-STAT activating lesions. Ruxolitinib was added to the AALL1131 high-risk chemotherapy backbone from consolidation onwards. Part 1 established the safe dose and schedule; Part 2 measures three-year event-free survival in each genetic cohort.\n\nThe study enrolled 171 patients and is recorded as completed with a primary completion date of March 2026. No primary results have been posted on the registry or published in a journal indexed by Europe PMC, so the corpus records what the trial tests and not a result. The Philadelphia-like leukaemia page cites it as the trial through which ruxolitinib is being added to chemotherapy.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02723994","url":"https://clinicaltrials.gov/study/NCT02723994"}],"tags":["soc-trials"],"related":[],"cancers":["all-ph-like","all-leukemia","leukaemia"],"sections":[],"technologies":["kinase-inhibitors","cytotoxic-chemotherapy"],"targets":[],"drugs":["ruxolitinib"],"companies":["incyte","childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02723994","phase":"2","setting":"Children and young adults with newly diagnosed high-risk Philadelphia chromosome-like B-cell acute lymphoblastic leukaemia carrying a CRLF2 rearrangement or a JAK pathway mutation: the JAK1 and JAK2 inhibitor ruxolitinib added to post-induction chemotherapy, in a dose-finding part and an efficacy part with three-year event-free survival as the endpoint","sponsor":"Incyte Corporation","started":"2016-09-30","startedType":"actual","enrolled":171,"enrolledBasis":"registry","outcomes":[]},{"id":"aaml1031","kind":"trial","name":"AAML1031","aka":["COG AAML1031"],"tldr":"AAML1031 was the children's leukaemia trial that found adding bortezomib to standard chemotherapy did not help and caused more nerve damage, while a separate part of the trial suggested that adding the FLT3 blocker sorafenib does improve outcomes for children whose leukaemia carries a high load of the FLT3-ITD mutation.","summary":"AAML1031 was the Children's Oncology Group phase 3 trial for de novo acute myeloid leukaemia in patients under 30. Patients without a high allelic ratio FLT3-ITD mutation were randomised to standard chemotherapy (four courses, or three followed by allogeneic transplant for high-risk disease) with or without bortezomib on days 1, 4 and 8 of each course. Patients with high allelic ratio FLT3-ITD received sorafenib in three sequential cohorts that defined the dose and then added it to induction and as single-agent maintenance.\n\nBortezomib did not improve remission, event-free or overall survival and increased peripheral neuropathy and intensive care admissions. In the FLT3-ITD cohorts, patients given sorafenib had better event-free survival than a comparator group of high allelic ratio patients treated with identical chemotherapy without sorafenib, and multivariable analysis accounting for transplant and co-occurring favourable mutations confirmed the benefit. The trial is why the standard-of-care text for childhood acute myeloid leukaemia adds sorafenib to chemotherapy for high allelic ratio FLT3-ITD disease.","status":"mixed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01371981","url":"https://clinicaltrials.gov/study/NCT01371981"}],"tags":["soc-trials"],"related":[],"cancers":["aml-paediatric","aml-flt3","aml","leukaemia"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["bortezomib","sorafenib"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-aaml1031-bortezomib-aplenc-haematologica-2020","paper-aaml1031-sorafenib-flt3-pollard-jco-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01371981","phase":"3","setting":"Newly diagnosed acute myeloid leukaemia in patients under 30: standard chemotherapy with or without bortezomib (randomised), and for high allelic ratio FLT3-ITD disease the addition of sorafenib to chemotherapy and as maintenance (non-randomised cohorts)","sponsor":"National Cancer Institute (NCI)","result":"Bortezomib added to chemotherapy did not improve three-year event-free survival (44.8 percent against 47.0 percent) and added toxicity; sorafenib for high allelic ratio FLT3-ITD disease roughly halved the hazard of an event compared with matched patients treated without it.","started":"2011-07-06","startedType":"actual","yearReported":2020,"enrolled":1645,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 3 years, bortezomib randomisation","primary":true,"unit":"%","arms":[{"name":"Chemotherapy + bortezomib","n":555,"value":44.8},{"name":"Chemotherapy alone","n":542,"value":47}],"p":"0.236","source":"https://doi.org/10.3324/haematol.2019.220962"},{"endpoint":"Overall survival at 3 years, bortezomib randomisation","unit":"%","arms":[{"name":"Chemotherapy + bortezomib","n":555,"value":63.6},{"name":"Chemotherapy alone","n":542,"value":67.2}],"p":"0.356","source":"https://doi.org/10.3324/haematol.2019.220962"},{"endpoint":"Complete remission after induction, bortezomib randomisation","unit":"%","arms":[{"name":"Chemotherapy + bortezomib","n":555,"value":89},{"name":"Chemotherapy alone","n":542,"value":91}],"p":"0.531","source":"https://doi.org/10.3324/haematol.2019.220962"},{"endpoint":"Event-free survival from study entry, high allelic ratio FLT3-ITD (hazard for patients not given sorafenib against sorafenib cohorts 2 and 3)","arms":[{"name":"Chemotherapy without sorafenib (comparator)","n":76},{"name":"Chemotherapy + sorafenib (cohorts 2 and 3)","n":72}],"hr":2.37,"ci":[1.45,3.88],"source":"https://doi.org/10.1200/jco.21.01612"},{"endpoint":"Relapse risk from complete remission, high allelic ratio FLT3-ITD (hazard for patients not given sorafenib)","arms":[{"name":"Chemotherapy without sorafenib (comparator)","n":76},{"name":"Chemotherapy + sorafenib (cohorts 2 and 3)","n":72}],"hr":3.03,"ci":[1.31,7.04],"p":"0.010","source":"https://doi.org/10.1200/jco.21.01612"}]},{"id":"nct06245915","kind":"trial","name":"AB-2100, an Integrated Circuit T Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC)","aka":[],"tldr":"A phase 1/2 trial of AB-2100 in renal cell carcinoma, run by Arsenal Biosciences, Inc., active and no longer recruiting.","summary":"AB-2100, an Integrated Circuit T Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC) is a phase 1/2 interventional study registered as NCT06245915 by Arsenal Biosciences, Inc., with 37 participants enrolled, started 2024-02-26 and due to reach its primary completion in 2026-03-31. Interventions recorded: AB-2100.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06245915","url":"https://clinicaltrials.gov/study/NCT06245915"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc","clear-cell-rcc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["arsenal-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06245915","phase":"1/2","setting":"An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-2100 in Patients With Recurrent Advanced or Metastatic Clear-cell Renal Cell Carcinoma (ccRCC)","sponsor":"Arsenal Biosciences, Inc.","started":"2024-02-26","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07285694","kind":"trial","name":"AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)","aka":[],"tldr":"A phase 1/2 trial of AB-3028 in prostate cancer, run by Arsenal Biosciences, Inc., active and no longer recruiting.","summary":"AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC) is a phase 1/2 interventional study registered as NCT07285694 by Arsenal Biosciences, Inc., with 190 participants enrolled, started 2026-01-09 and due to reach its primary completion in 2029-05. Interventions recorded: AB-3028.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07285694","url":"https://clinicaltrials.gov/study/NCT07285694"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["arsenal-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07285694","phase":"1/2","setting":"An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-3028 in Patients With Castration Resistant Prostate Cancer (CRPC)","sponsor":"Arsenal Biosciences, Inc.","started":"2026-01-09","startedType":"actual","enrolled":190,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05211570","kind":"trial","name":"AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia","aka":[],"tldr":"A phase 1/2 trial of Venetoclax in acute myeloid leukaemia, run by AB Science, now recruiting.","summary":"AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia is a phase 1/2 interventional study registered as NCT05211570 by AB Science, with 78 participants planned, started 2022-06-01 and due to reach its primary completion in 2026-08. Interventions recorded: AB8939 and Venetoclax.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05211570","url":"https://clinicaltrials.gov/study/NCT05211570"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["venetoclax"],"companies":["ab-science"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05211570","phase":"1/2","setting":"A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia","sponsor":"AB Science","started":"2022-06-01","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00841113","kind":"trial","name":"Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Abarelix in Prostate cancer, run by Speciality European Pharma Limited, completed.","summary":"Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer is a phase 3 interventional study registered as NCT00841113 by Speciality European Pharma Limited, with 177 participants recorded, started 1999-01 and reaching its primary completion in 2001-02. Interventions recorded: Abarelix, Goserelin plus Bicalutamide. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Abarelix because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00841113","url":"https://clinicaltrials.gov/study/NCT00841113"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["abarelix"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00841113","phase":"3","setting":"Phase III Study of the Comparison of Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer. A One Year Randomised, Open Label, Multi-Centre Phase III Trial.","sponsor":"Speciality European Pharma Limited","started":"1999-01","enrolled":177,"enrolledBasis":"registry","outcomes":[]},{"id":"abc-02","kind":"trial","name":"ABC-02","aka":[],"tldr":"ABC-02 was the 2010 UK trial that gave bile duct cancer its first standard chemotherapy: 410 patients with advanced biliary tract cancer were randomised to gemcitabine plus cisplatin or gemcitabine alone, and the doublet lengthened life and delayed progression. It stayed the control arm for every first-line trial for more than a decade.","summary":"ABC-02, sponsored by Cancer Research UK and reported in the New England Journal of Medicine in 2010, was the UK trial that gave bile duct cancer its first standard chemotherapy, gemcitabine plus cisplatin. It randomised 410 patients with locally advanced or metastatic biliary tract cancer to the doublet or gemcitabine alone, met its primary overall survival endpoint and delayed progression, and remained the control arm for every subsequent first-line trial for more than a decade. OnCo links it to biliary tract and gallbladder cancer, the gemcitabine plus cisplatin record, Cancer Research UK and Juan W. Valle, and the result was confirmed by the Japanese BT22 trial. Whether triplet chemotherapy or immunotherapy additions, as in TOPAZ-1, now make the doublet alone obsolete is the question that followed.","status":"positive","asOf":"2026-09-07","links":[{"label":"NEJM 2010","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa0908721"},{"label":"ClinicalTrials.gov NCT00262769","url":"https://clinicaltrials.gov/study/NCT00262769"},{"label":"ISRCTN82956140","url":"https://www.isrctn.com/ISRCTN82956140"}],"tags":[],"related":[],"cancers":["cholangiocarcinoma","gallbladder","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine-cisplatin"],"companies":[],"institutions":["cruk"],"pathways":[],"terms":[],"trials":[],"people":["juan-valle"],"bottlenecks":[],"keyPapers":["paper-abc-02-gemcitabine-cisplatin-nejm-2010"],"journals":[],"dependsOn":[],"notes":["Gallbladder cancer: the registry conditions are extrahepatic bile duct cancer and gallbladder cancer, and eligibility was histologically or cytologically confirmed biliary tract, gallbladder or ampullary carcinoma; sponsored by University College London and run at 25 UK sites (ClinicalTrials.gov NCT00262769, ISRCTN82956140)."],"nct":"NCT00262769","phase":"3","setting":"Locally advanced or metastatic biliary tract cancer: gemcitabine + cisplatin vs gemcitabine","sponsor":"Cancer Research UK","result":"OS 11.7 vs 8.1 months, HR 0.64.","started":"2005-05","yearReported":2010,"enrolled":410,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Gemcitabine + cisplatin","n":204,"value":11.7},{"name":"Gemcitabine","n":206,"value":8.1}],"hr":0.64,"ci":[0.52,0.8],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa0908721"}],"replication":"Confirmed by the Japanese BT22 trial and a decade of use as control arm."},{"id":"abc-06","kind":"trial","name":"ABC-06","aka":[],"tldr":"ABC-06 was the first randomised trial to show that a second round of chemotherapy, FOLFOX, helps people with bile duct and gallbladder cancer live somewhat longer once gemcitabine and cisplatin have stopped working.","summary":"The UK ABC-06 trial randomised 162 patients with locally advanced or metastatic biliary tract cancer (cholangiocarcinoma, gallbladder or ampullary cancer) whose disease had progressed on first-line gemcitabine and cisplatin to active symptom control alone or with modified FOLFOX (oxaliplatin, folinic acid and fluorouracil). The primary endpoint was overall survival.\n\nFOLFOX produced a modest but significant improvement in overall survival with acceptable toxicity, and gave biliary cancer its first evidence-based second-line chemotherapy. Targeted drugs for FGFR2 and IDH1 alterations and the NIFTY trial of liposomal irinotecan have since added other options.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01926236","url":"https://clinicaltrials.gov/study/NCT01926236"},{"label":"Lamarca et al., Lancet Oncology 2021: ABC-06","url":"https://doi.org/10.1016/S1470-2045(21)00027-9"}],"tags":["subtype-trials"],"related":[],"cancers":["cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","gallbladder","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["oxaliplatin","fluorouracil","leucovorin","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":["gallbladder-cancer-in-biliary-trials"],"trials":[],"people":["juan-valle","angela-lamarca"],"bottlenecks":[],"keyPapers":["paper-abc-06-folfox-second-line-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":["Gallbladder cancer: eligibility was histologically or cytologically verified non-resectable or recurrent or metastatic cholangiocarcinoma, gallbladder or ampullary carcinoma after progression on cisplatin and gemcitabine (registry conditions: biliary tract cancer, gallbladder cancer, cholangiocarcinoma, ampullary cancer); the gallbladder share and a gallbladder-specific hazard ratio are not in the abstract. FOLFOX after gemcitabine and cisplatin is the NHS second-line standard that NICE used as the comparator for ivosidenib (TA948), pemigatinib (TA722) and zanidatamab (TA1153).","UK sites (17, registry): Queen Elizabeth Hospital Birmingham; Bristol Haematology and Oncology Centre; North Cumbria (Carlisle); Beatson (Glasgow); Castle Hill (Hull); St James's (Leeds); Clatterbridge (Liverpool); Guy's and St Thomas', Hammersmith, Royal Free and University College London (London); Maidstone Hospital; The Christie (Manchester); Nottingham City Hospital; Churchill (Oxford); Weston Park (Sheffield)."],"nct":"NCT01926236","phase":"3","setting":"Advanced biliary tract cancer after progression on gemcitabine and cisplatin: active symptom control with or without modified FOLFOX","sponsor":"The Christie NHS Foundation Trust","result":"Modified FOLFOX plus active symptom control modestly improved overall survival over active symptom control alone.","started":"2014-02","yearReported":2019,"enrolled":162,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Active symptom control + FOLFOX","n":81,"value":6.2,"note":"Adjusted hazard ratio; median follow-up 21.7 months"},{"name":"Active symptom control alone","n":81,"value":5.3}],"hr":0.69,"ci":[0.5,0.97],"p":"0.031","source":"https://doi.org/10.1016/s1470-2045(21)00027-9"},{"endpoint":"Overall survival at 12 months","unit":"%","arms":[{"name":"Active symptom control + FOLFOX","n":81,"value":25.9},{"name":"Active symptom control alone","n":81,"value":11.4}],"source":"https://doi.org/10.1016/s1470-2045(21)00027-9"},{"endpoint":"Overall survival at 6 months","unit":"%","arms":[{"name":"Active symptom control + FOLFOX","n":81,"value":50.6},{"name":"Active symptom control alone","n":81,"value":35.5}],"source":"https://doi.org/10.1016/s1470-2045(21)00027-9"},{"endpoint":"Grade 3-5 adverse events","unit":"%","arms":[{"name":"Active symptom control + FOLFOX","n":81,"value":69,"note":"Three chemotherapy-related deaths"},{"name":"Active symptom control alone","n":81,"value":52}],"source":"https://doi.org/10.1016/s1470-2045(21)00027-9"}]},{"id":"abc-07","kind":"trial","name":"ABC-07","aka":[],"tldr":"ABC-07 is the UK trial asking whether focused high-dose radiotherapy after chemotherapy helps people whose bile duct or gallbladder cancer has not spread but cannot be removed. Twelve UK centres took part and its final results are awaited.","summary":"ABC-07 (ISRCTN10639376) is a randomised phase 2 in the UK ABC series for locally advanced biliary tract cancer. Patients receive six cycles of cisplatin and gemcitabine followed by stereotactic body radiotherapy (up to 50 Gy in 5 fractions or 67.5 Gy in 15 fractions) or eight cycles of cisplatin and gemcitabine; the primary outcome, updated in August 2026, is progression-free survival from randomisation to progression on CT or MRI by RECIST 1.1 or death. The target was 83 patients, the registry end date is 12 August 2026, and the radiotherapy quality assurance paper (Clinical Oncology 2026) reports that 12 UK centres recruited and 41 patients were randomised to the radiotherapy arm, with protocol deviations in 46 percent of plans, mostly unavoidable target coverage compromise because of the duodenum and other nearby organs. Sites listed include the Churchill Hospital Oxford, University College Hospital, the Royal Marsden, Mount Vernon, the Lister Hospital, the Royal Free, Velindre, St Bartholomew's, Hammersmith, Southampton General and Addenbrooke's. For gallbladder cancer with hilar involvement it is the UK counterpart of the Indian RUGB trial.","status":"active","asOf":"2026-09-24","links":[{"label":"ISRCTN10639376","url":"https://www.isrctn.com/ISRCTN10639376"},{"label":"Radiotherapy plan quality assurance in the ABC-07 trial (Clinical Oncology 2026)","url":"https://doi.org/10.1016/j.clon.2025.103993"},{"label":"Cancer Research UK trial page: ABC-07","url":"https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-chemotherapy-stereotactic-radiotherapy-people-locally-advanced-bile-duct-cancer-abc-07"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["sbrt","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine-cisplatin","gemcitabine","cisplatin"],"companies":[],"institutions":["cruk","uclh","royal-marsden"],"pathways":[],"terms":["radiotherapy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Churchill Hospital (Oxford); University College Hospital, Royal Marsden, Mount Vernon, Royal Free, St Bartholomew's and Hammersmith (London); Lister Hospital (Stevenage); Velindre (Cardiff); Southampton General; Addenbrooke's (Cambridge)."],"nct":"ISRCTN10639376","phase":"2","setting":"Locally advanced, non-metastatic biliary tract cancer: six cycles of cisplatin and gemcitabine followed by stereotactic body radiotherapy versus eight cycles of cisplatin and gemcitabine, UK randomised phase 2, primary endpoint progression-free survival","sponsor":"University College London (Cancer Research UK)","enrolled":83,"enrolledBasis":"registry","outcomes":[]},{"id":"abc-12","kind":"trial","name":"ABC-12","aka":[],"tldr":"ABC-12 collects mouth and bowel bacteria samples from UK patients having standard chemotherapy with durvalumab for bile duct or gallbladder cancer, to see whether the microbiome predicts who responds.","summary":"ABC-12 (ISRCTN11210442) is a UK study, led from The Christie with AstraZeneca support, in patients with biliary tract adenocarcinoma, including cholangiocarcinoma and gallbladder carcinoma, receiving durvalumab with cisplatin and gemcitabine as their standard of care. The primary outcome is baseline alpha diversity (number of species) in microbiome samples from responders (partial or complete response by RECIST 1.1) and non-responders at 18 weeks. Seventy patients are targeted at ten NHS trusts (The Christie, Imperial, Cambridge, Royal Free, Oxford, Birmingham, Clatterbridge, Nottingham, Velindre and University College London Hospitals) with an end date of September 2026. It is a companion study to the TOPAZ-1 standard rather than a treatment trial.","status":"active","asOf":"2026-09-24","links":[{"label":"ISRCTN11210442","url":"https://www.isrctn.com/ISRCTN11210442"},{"label":"Cancer Research UK trial page: ABC-12","url":"https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-determine-whether-number-types-bacteria-gut-affects-how-well-treatment-works-bile-duct-cancer-abc-12"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","gemcitabine-cisplatin"],"companies":[],"institutions":["the-christie","uclh"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (10, registry): The Christie (Manchester); Imperial College Healthcare; Cambridge University Hospitals; Royal Free London; Oxford University Hospitals; University Hospitals Birmingham; Clatterbridge Cancer Centre; Nottingham University Hospitals; Velindre; University College London Hospitals."],"nct":"ISRCTN11210442","phase":"observational","setting":"Advanced biliary tract adenocarcinoma including gallbladder carcinoma treated with durvalumab, cisplatin and gemcitabine: mouth and gut microbiome sampling to compare responders and non-responders, UK translational study","sponsor":"The Christie NHS Foundation Trust","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07441369","kind":"trial","name":"Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer","aka":[],"tldr":"A phase 2 trial of abemaciclib, fOLFOX (5-FU, leucovorin, oxaliplatin), leucovorin (folinic acid), fluorouracil (5-FU) and other drugs in colorectal cancer, run by Fudan University, now recruiting.","summary":"Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer is a phase 2, interventional study registered as NCT07441369 by Fudan University, with a registry enrolment figure of 16 participants, started 2026-07-30 and due to reach its primary completion in 2027-04-30. Interventions recorded: Abemaciclib; Oxaliplatin; Calcium Folinate; 5-Fluorouracil; Irinotecan. Conditions listed: Liver Metastases From Colorectal Cancer (mCRC). Primary outcome: ORR. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed unresectable advanced colorectal liver metastases cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07441369","url":"https://clinicaltrials.gov/study/NCT07441369"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["abemaciclib","folfox","leucovorin","fluorouracil","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07441369","phase":"2","setting":"Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard Two or Three-line Therapy","sponsor":"Fudan University","started":"2026-07-30","startedType":"estimated","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05422911","kind":"trial","name":"Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.","aka":[],"tldr":"A phase 2 trial of Abiraterone acetate, Apalutamide, Enzalutamide in metastatic cancer and prostate cancer, run by Sun Pharmaceutical Industries Limited, now recruiting.","summary":"Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer. is a phase 2 interventional study registered as NCT05422911 by Sun Pharmaceutical Industries Limited, with 192 participants planned, started 2022-08-31 and due to reach its primary completion in 2027-12-31. Interventions recorded: Abiraterone acetate, Apalutamide, Enzalutamide. Conditions listed: Metastatic Cancer, Neoplasm, Prostate, Castrate-sensitive, Castrate-sensitive Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05422911","url":"https://clinicaltrials.gov/study/NCT05422911"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","prostate"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["abiraterone","apalutamide","enzalutamide"],"companies":["sun-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05422911","phase":"2","setting":"A Phase 2 Randomized Study of Abiraterone Acetate, Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer","sponsor":"Sun Pharmaceutical Industries Limited","started":"2022-08-31","startedType":"actual","enrolled":192,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07158918","kind":"trial","name":"ABL103 in Combination With Pembrolizumab, With or Without Taxane in Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by ABL Bio, Inc., now recruiting.","summary":"ABL103 in Combination With Pembrolizumab, With or Without Taxane in Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT07158918 by ABL Bio, Inc., with 65 participants planned, started 2025-08-06 and due to reach its primary completion in 2027-12-02. Interventions recorded: ABL103, KEYTRUDA® (pembrolizumab) and Taxane.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07158918","url":"https://clinicaltrials.gov/study/NCT07158918"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07158918","phase":"1/2","setting":"A Multicenter, Open-label, Phase 1b/2 Trial of ABL103, a Bispecific Antibody of B7-H4 and 4-1BB, in Combination With Pembrolizumab With/Without Taxane in Subjects With Selected, Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors","sponsor":"ABL Bio, Inc.","started":"2025-08-06","startedType":"actual","enrolled":65,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02788981","kind":"trial","name":"Abraxane® With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of Mifepristone and Paclitaxel / nab-paclitaxel in Breast cancer, run by University of Chicago, active and no longer recruiting.","summary":"Abraxane® With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer is a phase 2 interventional study registered as NCT02788981 by University of Chicago, with 29 participants planned, started 2017-03-28 and due to reach its primary completion in 2022-12-21. Interventions recorded: Mifepristone, Placebo, Nab-Paclitaxel. Conditions recorded: Breast Cancer.\n\nLinked to the drug Mifepristone because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02788981","url":"https://clinicaltrials.gov/study/NCT02788981"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["mifepristone","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02788981","phase":"2","setting":"A Randomized, Placebo-Controlled, Double-Blind, Phase II Trial of Nanoparticle Albumin-Bound Paclitaxel (Nab-Paclitaxel, Abraxane®) With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer","sponsor":"University of Chicago","started":"2017-03-28","startedType":"actual","yearReported":2024,"enrolled":29,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Nab-Paclitaxel+Mifepristone","n":13,"value":3,"note":"95% CI 1.0 to 5.0; Figures from the ClinicalTrials.gov results section (first posted 2024-02-16), not from a publication"},{"name":"Nab-Paclitaxel+Placebo","n":13,"value":3,"note":"95% CI 1.0 to 6.0"}],"source":"https://clinicaltrials.gov/study/NCT02788981?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"Nab-Paclitaxel+Mifepristone","n":13,"value":9,"note":"95% CI 6.0 to 28.0; Figures from the ClinicalTrials.gov results section (first posted 2024-02-16), not from a publication"},{"name":"Nab-Paclitaxel+Placebo","n":14,"value":6,"note":"95% CI 2.0 to 15.0"}],"source":"https://clinicaltrials.gov/study/NCT02788981?tab=results"}]},{"id":"nct07327034","kind":"trial","name":"ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 Overexpression","aka":[],"tldr":"A phase 2 trial of ABSK-011+BSC in hepatocellular carcinoma, run by Abbisko Therapeutics Co, Ltd, now recruiting.","summary":"ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 Overexpression is a phase 2 interventional study registered as NCT07327034 by Abbisko Therapeutics Co, Ltd, with 141 participants planned, started 2025-06-13 and due to reach its primary completion in 2027-06-30. Interventions recorded: ABSK-011+BSC and Placebo+BSC.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07327034","url":"https://clinicaltrials.gov/study/NCT07327034"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["abbisko"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07327034","phase":"2","setting":"A Randomized, Double-blind, Multi-center, Phase 2 Study to Assess the Efficacy and Safety of ABSK-011 Plus Best Supportive Care (BSC) vs. Placebo Plus BSC in Previously Systemically Treated Advanced or Unresectable Hepatocellular Carcinoma Patients With FGF19 Overexpression","sponsor":"Abbisko Therapeutics Co, Ltd","started":"2025-06-13","startedType":"actual","enrolled":141,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03897543","kind":"trial","name":"ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma","aka":[],"tldr":"A phase 1/2 trial of ABX196 in hepatocellular carcinoma, run by Abivax S.A., now recruiting.","summary":"ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma is a phase 1/2 interventional study registered as NCT03897543 by Abivax S.A., with 48 participants planned, started 2019-08-30 and due to reach its primary completion in 2021-06-30. Interventions recorded: ABX196.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03897543","url":"https://clinicaltrials.gov/study/NCT03897543"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03897543","phase":"1/2","setting":"A Phase 1-2 Study of ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma","sponsor":"Abivax S.A.","started":"2019-08-30","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04624633","kind":"trial","name":"Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL","aka":[],"tldr":"A phase 2 trial of Acalabrutinib and Umbralisib in Chronic lymphocytic leukaemia, run by Jennifer R. Brown, MD, PhD, active and no longer recruiting.","summary":"Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL is a phase 2 interventional study registered as NCT04624633 by Jennifer R. Brown, MD, PhD, with 29 participants planned, started 2020-12-15 and due to reach its primary completion in 2023-12-21. Interventions recorded: Acalabrutinib, Umbralisib, Ublituximab. Conditions recorded: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia.\n\nLinked to the drug Umbralisib because the registry names it among its interventions and Chronic lymphocytic leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04624633","url":"https://clinicaltrials.gov/study/NCT04624633"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll"],"sections":[],"technologies":[],"targets":[],"drugs":["acalabrutinib","umbralisib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04624633","phase":"2","setting":"A Phase 2 Study of Acalabrutinib, Umbralisib, and Ublituximab (AU2) in Relapsed and Previously Untreated CLL Patients","sponsor":"Jennifer R. Brown, MD, PhD","started":"2020-12-15","startedType":"actual","yearReported":2025,"enrolled":29,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete Remission (CR) Rate After 24 Cycles","primary":true,"unit":"proportion of participants","arms":[{"name":"Cohort 1 - Relapsed Disease","n":6,"value":0.33,"note":"95% CI 0.043 to 0.777; Figures from the ClinicalTrials.gov results section (first posted 2025-02-27), not from a publication"},{"name":"Cohort 2 - Treatment Naive","n":14,"value":0.29,"note":"95% CI 0.084 to 0.582"}],"source":"https://clinicaltrials.gov/study/NCT04624633?tab=results"}]},{"id":"nct00261313","kind":"trial","name":"ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer","aka":[],"tldr":"A phase 2 trial of Pegfilgrastim and Darbepoetin alfa in Breast cancer, run by Amgen, completed.","summary":"ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer is a phase 2 interventional study registered as NCT00261313 by Amgen, with 80 participants recorded, started 2005-12 and reaching its primary completion in 2007-06. Interventions recorded: Neulasta, Aranesp. Conditions recorded: Breast Cancer.\n\nLinked to the drug Darbepoetin alfa because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00261313","url":"https://clinicaltrials.gov/study/NCT00261313"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer","male-breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pegfilgrastim","darbepoetin-alfa"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00261313","phase":"2","setting":"An Open Label Phase 2 Study of Doxorubicin and Cyclophosphamide Followed by Paclitaxel Delivered Every 14 Days With Pegfilgrastim and Darbepoetin Alfa Support for the Adjuvant Treatment of Women With Breast Cancer","sponsor":"Amgen","started":"2005-12","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05355298","kind":"trial","name":"ACCENT: AMP945 in Combination With Nab-paclitaxel and Gemcitabine for Treatment of Pancreatic Cancer","aka":["ACCENT"],"tldr":"A phase 1/2 trial of AMP945 ascending doses in pancreatic ductal adenocarcinoma, run by Amplia Therapeutics Limited, active and no longer recruiting.","summary":"ACCENT: AMP945 in Combination With Nab-paclitaxel and Gemcitabine for Treatment of Pancreatic Cancer is a phase 1/2 interventional study registered as NCT05355298 by Amplia Therapeutics Limited, with 62 participants enrolled, started 2022-05-31 and due to reach its primary completion in 2027-02-01. Interventions recorded: AMP945 ascending doses and AMP945 RP2D.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05355298","url":"https://clinicaltrials.gov/study/NCT05355298"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":["amplia-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05355298","phase":"1/2","setting":"A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination With Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients","sponsor":"Amplia Therapeutics Limited","started":"2022-05-31","startedType":"actual","enrolled":62,"enrolledBasis":"registry","outcomes":[]},{"id":"ace-breast-02","kind":"trial","name":"ACE-Breast-02","aka":[],"tldr":"A site-specifically conjugated HER2 ADC beat lapatinib-capecitabine on progression-free survival in China.","summary":"ACE-Breast-02, a Chinese phase 3 sponsored by Zhejiang Medicine and Ambrx and reported in 2024 (it is registered in China rather than on ClinicalTrials.gov; NCT04829604 is the separate US study ACE-Breast-03), showed that ARX788, a HER2 antibody-drug conjugate made with site-specific conjugation, beat lapatinib plus capecitabine on progression-free survival in HER2-positive advanced breast cancer after trastuzumab and a taxane in China. It randomised 441 patients and met its primary endpoint with a clear reduction in the risk of progression; ARX788 uses non-natural amino acid conjugation from Ambrx, now part of Johnson & Johnson, with an MMAF-like payload, and ocular and pulmonary toxicity were noted. OnCo links it to site-specific conjugation and linker chemistry, ARX788 and lapatinib; a marketing application is planned in China with FDA Fast Track status. It is a single phase 3 against an older comparator, so how ARX788 compares with trastuzumab deruxtecan is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ACE-Breast-02 primary publication (PubMed)","url":"https://pubmed.ncbi.nlm.nih.gov/39956849/"}],"tags":[],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["site-specific-conjugation"],"targets":[],"drugs":["arx788","lapatinib"],"companies":["ambrx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"HER2+ advanced breast cancer after trastuzumab and taxane (China): ARX788 vs lapatinib + capecitabine","sponsor":"Zhejiang Medicine / Ambrx","result":"PFS 11.3 vs 8.2 months, HR 0.64.","yearReported":2024,"enrolled":441,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"ARX788","value":11.3},{"name":"Lapatinib + capecitabine","value":8.2}],"hr":0.64,"source":"https://pubmed.ncbi.nlm.nih.gov/39956849/"}],"replication":"Single phase 3; ACE-Breast-06 (brain metastases, phase 2) supportive."},{"id":"acns0121","kind":"trial","name":"ACNS0121","aka":["COG ACNS0121"],"tldr":"ACNS0121 showed that focused radiotherapy to the tumour bed straight after surgery cures most children with ependymoma, including those under three who used to be denied radiotherapy, and that children whose tumour could not be fully removed do far worse even with chemotherapy and a second operation.","summary":"ACNS0121 was a Children's Oncology Group phase 2 trial of 378 children with newly diagnosed ependymoma, assigned by extent of resection and histology. Children with completely resected, differentiated supratentorial tumours were observed; those with near-total or gross-total resection received immediate post-operative conformal radiotherapy to 59.4 Gy (54 Gy under 18 months); those with subtotal resection received chemotherapy (vincristine, carboplatin, cyclophosphamide, etoposide) before second-look surgery and radiotherapy. The primary endpoint was event-free survival.\n\nFive-year event-free survival was 68.5 percent after immediate conformal radiotherapy, 61.4 percent in the observation group and 37.2 percent after subtotal resection. Outcomes were similar for children under three, tumour grade mattered, and 1q gain in posterior fossa tumours predicted relapse (five-year event-free survival 47.4 against 82.8 percent). The corpus's ependymoma page describes maximal resection followed by conformal or proton radiotherapy to the tumour bed as the ACNS0121 approach.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00027846","url":"https://clinicaltrials.gov/study/NCT00027846"}],"tags":["soc-trials"],"related":[],"cancers":["ependymoma","brain-tumours","childhood-cancers"],"sections":[],"technologies":["imrt-igrt","cytotoxic-chemotherapy"],"targets":[],"drugs":["carboplatin","cyclophosphamide","etoposide","vincristine"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-acns0121-ependymoma-conformal-radiotherapy-merchant-jco-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00027846","phase":"2","setting":"Newly diagnosed localised ependymoma in children aged 1 to 21: observation after complete resection of differentiated supratentorial tumours, immediate conformal radiotherapy after near-total or gross-total resection, and chemotherapy before second surgery and radiotherapy after subtotal resection","sponsor":"Children's Oncology Group","result":"Five-year event-free survival 68.5 percent with immediate post-operative conformal radiotherapy, 61.4 percent with observation after complete resection of differentiated supratentorial tumours, and 37.2 percent after subtotal resection with chemotherapy, second surgery and radiotherapy.","started":"2003-08","yearReported":2019,"enrolled":378,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 5 years by treatment group","primary":true,"unit":"%","arms":[{"name":"Near-total or gross-total resection then immediate conformal radiotherapy","value":68.5,"note":"95% CI 62.8 to 74.2"},{"name":"Observation after complete resection of differentiated supratentorial ependymoma","value":61.4,"note":"95% CI 34.5 to 89.6"},{"name":"Subtotal resection: chemotherapy, second surgery, radiotherapy","value":37.2,"note":"95% CI 24.8 to 49.6"}],"source":"https://doi.org/10.1200/JCO.18.01765"},{"endpoint":"Event-free survival at 5 years, infratentorial tumours by 1q status","unit":"%","arms":[{"name":"Without 1q gain","value":82.8},{"name":"With 1q gain","value":47.4}],"p":"0.0013","source":"https://doi.org/10.1200/JCO.18.01765"}]},{"id":"acns0122","kind":"trial","name":"ACNS0122","aka":["COG ACNS0122"],"tldr":"ACNS0122 set the modern American standard for children with the more aggressive kind of germ cell tumour of the brain: chemotherapy first, surgery for anything left, then radiotherapy to the whole brain and spine, which cured about nine in ten and became the benchmark that later trials tried to match with less radiation.","summary":"ACNS0122 was a Children's Oncology Group phase 2 study of 104 patients with newly diagnosed non-germinomatous germ cell tumours of the central nervous system. Induction was six cycles of carboplatin and etoposide alternating with ifosfamide and etoposide; patients with residual disease had second-look surgery, and those still not in complete response received high-dose thiotepa and etoposide with autologous stem cell rescue before craniospinal irradiation of 36 Gy with a boost to 54 Gy. The primary endpoint was the response rate to induction.\n\nIn the registry results 74 of 85 evaluable patients responded to induction chemotherapy. Three-year progression-free and overall survival were 92 and 94.1 percent, figures quoted as the benchmark in the successor trial ACNS1123, which tested reduced whole-ventricular radiotherapy against this standard. The corpus's germ cell tumour pages cite ACNS0122 for the chemotherapy-then-craniospinal-irradiation approach.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00047320","url":"https://clinicaltrials.gov/study/NCT00047320"}],"tags":["soc-trials"],"related":[],"cancers":["cns-germ-cell-tumours","brain-tumours","childhood-cancers"],"sections":[],"technologies":["cytotoxic-chemotherapy","autologous-stem-cell-transplant"],"targets":[],"drugs":["carboplatin","etoposide","ifosfamide","thiotepa"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-acns1123-nggct-reduced-radiotherapy-fangusaro-jco-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00047320","phase":"2","setting":"Newly diagnosed central nervous system non-germinomatous germ cell tumours in children and young adults: six cycles of carboplatin, etoposide and ifosfamide, second-look surgery for residual disease, high-dose thiotepa and etoposide with stem cell rescue for poor responders, then craniospinal irradiation of 36 Gy with a boost","sponsor":"Children's Oncology Group","result":"74 of 85 evaluable patients responded to induction chemotherapy; three-year progression-free survival 92 percent and overall survival 94.1 percent with craniospinal irradiation, the benchmark used by ACNS1123.","started":"2004-01","yearReported":2015,"enrolled":104,"enrolledBasis":"registry","outcomes":[{"endpoint":"Response to induction chemotherapy (registry results)","primary":true,"unit":"participants","arms":[{"name":"Responders","value":74},{"name":"Non-responders","value":11}],"source":"https://clinicaltrials.gov/study/NCT00047320?tab=results"},{"endpoint":"Progression-free survival at 3 years (as reported in the ACNS1123 comparison)","unit":"%","arms":[{"name":"Chemotherapy, second-look surgery, 36 Gy craniospinal irradiation with boost","value":92}],"source":"https://doi.org/10.1200/JCO.19.00701"},{"endpoint":"Overall survival at 3 years (as reported in the ACNS1123 comparison)","unit":"%","arms":[{"name":"Chemotherapy, second-look surgery, 36 Gy craniospinal irradiation with boost","value":94.1}],"source":"https://doi.org/10.1200/JCO.19.00701"}]},{"id":"acns0333","kind":"trial","name":"ACNS0333","aka":["COG ACNS0333"],"tldr":"ACNS0333 was the first trial built only for atypical teratoid/rhabdoid tumour, a brain cancer of very young children that used to be almost always fatal; its intensive plan of chemotherapy, high-dose chemotherapy with stem cell rescue and focused radiotherapy more than halved the risk of relapse or death compared with earlier treatment and became the template for care.","summary":"ACNS0333 was the Children's Oncology Group's first trial specific to atypical teratoid/rhabdoid tumour. After surgery, 70 patients received two courses of multi-agent induction chemotherapy including high-dose methotrexate, then three courses of high-dose carboplatin and thiotepa with peripheral blood stem cell rescue, with involved-field three-dimensional conformal radiotherapy given before or after consolidation according to age and disease location. SMARCB1 testing of tumour and blood was mandatory. The primary analysis compared event-free survival in patients under 36 months with a historical cooperative group cohort.\n\nThe regimen cut the hazard of an event-free survival event by more than half in children under 36 months (hazard rate 0.43), and four-year event-free and overall survival for the whole cohort were 37 and 43 percent, far above historical figures; 91 percent of relapses occurred within two years and four patients died of treatment. The corpus's atypical teratoid/rhabdoid tumour page describes ACNS0333-style induction, high-dose chemotherapy with autologous rescue and focal radiotherapy on this evidence.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00653068","url":"https://clinicaltrials.gov/study/NCT00653068"}],"tags":["soc-trials"],"related":[],"cancers":["atrt","brain-tumours","childhood-cancers"],"sections":[],"technologies":["cytotoxic-chemotherapy","autologous-stem-cell-transplant","imrt-igrt"],"targets":[],"drugs":["carboplatin","cisplatin","cyclophosphamide","etoposide","thiotepa","methotrexate","vincristine"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-acns0333-atrt-high-dose-chemotherapy-reddy-jco-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00653068","phase":"3","setting":"Newly diagnosed atypical teratoid/rhabdoid tumour of the central nervous system from birth to 22 years: surgery, two courses of induction chemotherapy, three courses of high-dose chemotherapy with peripheral blood stem cell rescue and involved-field conformal radiotherapy timed by age and disease extent","sponsor":"Children's Oncology Group","result":"Hazard of an event 0.43 compared with the historical cohort in children under 36 months (p < 0.0005); four-year event-free survival 37 percent and overall survival 43 percent for all 65 evaluable patients.","started":"2009-02-10","startedType":"actual","yearReported":2020,"enrolled":70,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival, patients under 36 months against a historical cooperative group cohort","primary":true,"arms":[{"name":"ACNS0333 regimen (induction, high-dose chemotherapy with stem cell rescue, conformal radiotherapy)","n":54},{"name":"Historical cohort"}],"hr":0.43,"ci":[0.28,0.66],"p":"<0.0005","source":"https://doi.org/10.1200/JCO.19.01776"},{"endpoint":"Event-free survival at 4 years, entire cohort","unit":"%","arms":[{"name":"ACNS0333 regimen","n":65,"value":37,"note":"95% CI 25 to 49"}],"source":"https://doi.org/10.1200/JCO.19.01776"},{"endpoint":"Overall survival at 4 years, entire cohort","unit":"%","arms":[{"name":"ACNS0333 regimen","n":65,"value":43,"note":"95% CI 31 to 55"}],"source":"https://doi.org/10.1200/JCO.19.01776"},{"endpoint":"Treatment-related deaths","unit":"participants","arms":[{"name":"ACNS0333 regimen","n":65,"value":4}],"source":"https://doi.org/10.1200/JCO.19.01776"}]},{"id":"acns1123","kind":"trial","name":"ACNS1123","aka":["COG ACNS1123"],"tldr":"ACNS1123 asked whether children with germ cell tumours of the brain who respond well to chemotherapy can safely have less radiotherapy; for non-germinomatous tumours survival stayed high but the few relapses were all in the spine, which was left out of the smaller field, and for germinoma the reduced doses held.","summary":"ACNS1123 was a Children's Oncology Group phase 2 trial with two strata. Patients with localised non-germinomatous germ cell tumours received six cycles of carboplatin, etoposide and ifosfamide and, if they reached a complete or partial response (with second-look surgery where needed), reduced-dose whole-ventricular irradiation of 30.6 Gy with a boost to 54 Gy instead of the 36 Gy craniospinal irradiation used in the predecessor ACNS0122. Patients with localised germinoma received carboplatin and etoposide followed by response-adapted reduced-dose radiotherapy. Neurocognitive outcomes were measured alongside.\n\nIn the non-germinomatous stratum 66 of 107 patients qualified for reduced radiotherapy; their three-year progression-free survival was 87.8 percent and overall survival 92.4 percent, similar to ACNS0122, but ten recurrences prompted early closure of the stratum and every relapse involved the spine. The germinoma stratum had three-year progression-free survival of 86.5 percent in the registry results. The trial is the basis for whole-ventricular irradiation with a tumour boost after chemotherapy for non-germinomatous tumours, with craniospinal irradiation kept as an alternative, which is how the corpus's germ cell tumour pages cite it.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01602666","url":"https://clinicaltrials.gov/study/NCT01602666"}],"tags":["soc-trials"],"related":[],"cancers":["cns-germ-cell-tumours","paediatric-germ-cell-tumours","brain-tumours","childhood-cancers"],"sections":[],"technologies":["imrt-igrt","cytotoxic-chemotherapy"],"targets":[],"drugs":["carboplatin","etoposide","ifosfamide"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-acns1123-nggct-reduced-radiotherapy-fangusaro-jco-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01602666","phase":"2","setting":"Localised central nervous system germ cell tumours in children and young adults: induction chemotherapy (carboplatin, etoposide, ifosfamide) followed by reduced-dose, response-based radiotherapy, whole-ventricular with a tumour boost for non-germinomatous tumours and reduced-dose radiotherapy for germinoma","sponsor":"Children's Oncology Group","result":"Three-year progression-free survival 87.8 percent and overall survival 92.4 percent for non-germinomatous tumours given reduced whole-ventricular radiotherapy after a response to chemotherapy, with all relapses in the spine; three-year progression-free survival 86.5 percent for germinoma.","started":"2012-06-27","startedType":"actual","yearReported":2019,"enrolled":262,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 3 years, non-germinomatous germ cell tumours given reduced radiotherapy after chemotherapy response","primary":true,"unit":"%","arms":[{"name":"Chemotherapy then 30.6 Gy whole-ventricular irradiation with boost","n":66,"value":87.8,"note":"Standard error 4.04; 92 percent in ACNS0122 with craniospinal irradiation"}],"source":"https://doi.org/10.1200/JCO.19.00701"},{"endpoint":"Overall survival at 3 years, non-germinomatous stratum","unit":"%","arms":[{"name":"Chemotherapy then 30.6 Gy whole-ventricular irradiation with boost","n":66,"value":92.4}],"source":"https://doi.org/10.1200/JCO.19.00701"},{"endpoint":"Progression-free survival at 3 years, localised germinoma given reduced-dose radiotherapy (registry results)","primary":true,"unit":"%","arms":[{"name":"Carboplatin and etoposide then response-based reduced-dose radiotherapy","value":86.49,"note":"95% CI 76.55 to 93.32"}],"source":"https://clinicaltrials.gov/study/NCT01602666?tab=results"},{"endpoint":"Progression-free survival at 3 years, non-germinomatous stratum (registry results, all treated)","unit":"%","arms":[{"name":"Chemotherapy then reduced whole-ventricular irradiation","value":83.33,"note":"95% CI 72.13 to 91.38"}],"source":"https://clinicaltrials.gov/study/NCT01602666?tab=results"}]},{"id":"acns1422","kind":"trial","name":"ACNS1422","aka":["COG ACNS1422"],"tldr":"ACNS1422 tests whether children with the WNT type of medulloblastoma, who almost always survive, can be given less radiotherapy to the brain and spine and less chemotherapy without more relapses; it has finished enrolling and the results are awaited.","summary":"ACNS1422 is a single-arm Children's Oncology Group phase 2 study of reduced therapy for children with average-risk WNT-activated medulloblastoma, a subgroup with survival above 90 percent on standard treatment. Craniospinal irradiation is reduced from 23.4 Gy to 18 Gy with a reduced boost volume, and maintenance chemotherapy is shortened. The primary endpoint is progression-free survival.\n\nThe registry gives an estimated enrolment of 45 with a primary completion date of March 2028 and no results. The corpus's WNT medulloblastoma page cites it with the St. Jude SJMB12 study (15 Gy) as the trials that define reduced-dose radiotherapy for this subgroup.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02724579","url":"https://clinicaltrials.gov/study/NCT02724579"}],"tags":["soc-trials"],"related":[],"cancers":["medulloblastoma-wnt","medulloblastoma","brain-tumours","childhood-cancers"],"sections":[],"technologies":["imrt-igrt","cytotoxic-chemotherapy"],"targets":[],"drugs":["cisplatin","cyclophosphamide","lomustine","vincristine"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02724579","phase":"2","setting":"Newly diagnosed average-risk WNT-driven medulloblastoma in children aged 3 to 21: reduced craniospinal irradiation of 18 Gy with a reduced tumour-bed boost and reduced maintenance chemotherapy (cisplatin, cyclophosphamide, lomustine, vincristine)","sponsor":"Children's Oncology Group","started":"2017-11-17","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"acosog-z0011","kind":"trial","name":"ACOSOG Z0011 (Alliance)","aka":["Z0011","Z11","ACOSOG Z11"],"tldr":"Z0011 is the trial that stopped surgeons clearing the armpit when one or two sentinel nodes contain cancer. Ten years on, the women who kept their remaining nodes were no more likely to have died, and the cancer came back in the armpit in almost nobody.","summary":"Z0011 enrolled 891 women from 1999 to 2004 at 115 academic and community centres with clinical T1 or T2 breast cancer, no palpable axillary nodes, and one or two sentinel nodes containing metastases. All had lumpectomy, planned tangential whole-breast irradiation and adjuvant systemic therapy; a third radiotherapy field aimed at the nodes was prohibited. They were randomised to sentinel node dissection alone or to completion axillary clearance. Overall survival was the primary endpoint with a non-inferiority margin of 1.3.\n\nThe trial first reported in 2005 with a median follow-up of 6.3 years. Longer follow-up mattered because most of the tumours were oestrogen receptor-positive and recur late. At a median 9.3 years, ten-year overall survival was 86.3 percent with sentinel node dissection alone and 83.6 percent with clearance (hazard ratio 0.85, one-sided 95 percent confidence interval 0 to 1.16, non-inferiority p=0.02). Ten-year disease-free survival was 80.2 against 78.2 percent (hazard ratio 0.85, 0.62 to 1.17, p=0.32). Between year five and year ten there was a single regional recurrence in the sentinel node arm and none in the clearance arm.\n\nTwo criticisms have followed the trial and both are fair. It closed early and is underpowered for a small survival difference. And every patient had whole-breast tangential radiotherapy, whose upper field edge treats part of the low axilla incidentally, so \"no axillary treatment\" is not quite what the experimental arm received. SENOMAC was designed to answer both, and reached the same conclusion in a population including mastectomy patients.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00003855","url":"https://clinicaltrials.gov/study/NCT00003855"},{"label":"Z0011 ten-year overall survival (JAMA 2017)","url":"https://doi.org/10.1001/jama.2017.11470"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["sentinel-node","imrt-igrt"],"targets":[],"drugs":[],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":["sentinel-lymph-node-biopsy","lymphadenectomy","axillary-surgery-de-escalation","breast-cancer-related-lymphoedema"],"trials":["amaros","ibcsg-23-01","senomac","posnoc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003855","phase":"3","setting":"Clinical T1 or T2 invasive breast cancer, no palpable axillary nodes, one or two positive sentinel nodes, all having lumpectomy with tangential whole-breast irradiation and systemic therapy: sentinel node dissection alone against axillary clearance, with overall survival as the primary endpoint and a non-inferiority margin of 1.3","sponsor":"Alliance for Clinical Trials in Oncology","result":"Ten-year overall survival 86.3 percent with sentinel node dissection alone against 83.6 percent with axillary clearance (hazard ratio 0.85, non-inferiority p=0.02).","started":"1999-04","yearReported":2017,"enrolled":891,"enrolledBasis":"randomised","enrolledNote":"891 women were randomised in the published trial and 856 (96 percent) completed it; the ClinicalTrials.gov record NCT00003855 gives 605, and the two figures have not been reconciled on the registry.","outcomes":[{"endpoint":"Overall survival at 10 years","primary":true,"unit":"%","arms":[{"name":"Sentinel node dissection alone","n":446,"value":86.3},{"name":"Axillary lymph node dissection","n":445,"value":83.6}],"hr":0.85,"p":"0.02 for non-inferiority","source":"https://doi.org/10.1001/jama.2017.11470"},{"endpoint":"Disease-free survival at 10 years","unit":"%","arms":[{"name":"Sentinel node dissection alone","n":446,"value":80.2},{"name":"Axillary lymph node dissection","n":445,"value":78.2}],"hr":0.85,"ci":[0.62,1.17],"p":"0.32","source":"https://doi.org/10.1001/jama.2017.11470"}],"replication":"IBCSG 23-01 reached the same conclusion for micrometastases at ten years; AMAROS showed axillary radiotherapy is an equivalent alternative; SENOMAC extended the result to macrometastases, mastectomy and larger tumours in 2,540 patients."},{"id":"acosog-z1071","kind":"trial","name":"ACOSOG Z1071 (Alliance)","aka":["Z1071"],"tldr":"When chemotherapy is given first and clears the lymph nodes, can a surgeon trust the sentinel node to prove it? Z1071 found the sentinel node missed residual cancer about one time in eight, which is too often, and that finding forced the technique to be redesigned.","summary":"Z1071 enrolled 756 women at 136 institutions between 2009 and 2011 with clinical T0 to T4, N1 to N2, M0 breast cancer and biopsy-proven nodal disease. After chemotherapy every patient had both sentinel node surgery and completion axillary clearance, so the sentinel node result could be checked against the truth.\n\nOf 649 evaluable patients with cN1 disease, a sentinel node could not be found in 46 (7.1 percent) and only one was excised in 78 (12.0 percent). Among the 525 with two or more sentinel nodes removed, 215 had no cancer anywhere in the axilla, a pathological complete nodal response of 41.0 percent (95 percent confidence interval 36.7 to 45.3). In 39 patients the sentinel nodes were clear but the clearance specimen was not, a false-negative rate of 12.6 percent (90 percent Bayesian credible interval 9.85 to 16.05). The pre-specified acceptable threshold was 10 percent, and the trial did not meet it.\n\nZ1071 is filed here as a negative trial because it failed its own bar, and it is one of the most useful negative trials in surgical oncology: the response to it was not to abandon sentinel node surgery after chemotherapy but to fix it, with dual tracer mapping, a minimum of three nodes, and marking the biopsied node before chemotherapy so it can be found again. That last idea became targeted axillary dissection.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00881361","url":"https://clinicaltrials.gov/study/NCT00881361"},{"label":"ACOSOG Z1071 (JAMA 2013)","url":"https://doi.org/10.1001/jama.2013.278932"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["sentinel-node"],"targets":[],"drugs":[],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":["sentinel-lymph-node-biopsy","targeted-axillary-dissection","neoadjuvant-versus-adjuvant-breast","pcr"],"trials":["targeted-axillary-dissection-md-anderson","atnec"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00881361","phase":"2","setting":"Biopsy-proven node-positive breast cancer treated with chemotherapy before surgery: sentinel node surgery followed by axillary clearance in every patient, to measure the false-negative rate of the sentinel node after chemotherapy","sponsor":"American College of Surgeons Oncology Group, now part of the Alliance for Clinical Trials in Oncology","result":"False-negative rate of sentinel node surgery after chemotherapy 12.6 percent when two or more sentinel nodes were removed, above the 10 percent threshold; pathological complete nodal response 41.0 percent.","started":"2009-07","startedType":"actual","yearReported":2013,"enrolled":756,"enrolledBasis":"registry","outcomes":[{"endpoint":"False-negative rate of sentinel node surgery after chemotherapy (two or more sentinel nodes removed)","primary":true,"unit":"%","arms":[{"name":"Sentinel node surgery after chemotherapy","n":525,"value":12.6,"note":"90 percent Bayesian credible interval 9.85 to 16.05"}],"source":"https://doi.org/10.1001/jama.2013.278932"},{"endpoint":"Pathological complete nodal response","unit":"%","arms":[{"name":"Node-positive at diagnosis, after chemotherapy","n":525,"value":41,"note":"95 percent confidence interval 36.7 to 45.3"}],"source":"https://doi.org/10.1001/jama.2013.278932"}],"replication":"SENTINA in Europe and SN-FNAC in Canada found similar false-negative rates; the MD Anderson targeted axillary dissection study brought it down to 2.0 percent by marking the biopsied node."},{"id":"nct06850623","kind":"trial","name":"Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer","aka":["ENACT"],"tldr":"A phase 2 trial of Acoustic Cluster Therapy in pancreatic ductal adenocarcinoma, run by EXACT Therapeutics AS, now recruiting.","summary":"Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer is a phase 2 interventional study registered as NCT06850623 by EXACT Therapeutics AS, with 25 participants planned, started 2025-06-19 and due to reach its primary completion in 2026-12-15. Interventions recorded: Acoustic Cluster Therapy and Modified FOLFIRINOX.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06850623","url":"https://clinicaltrials.gov/study/NCT06850623"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["exact-sciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06850623","phase":"2","setting":"A Phase 2 Study to Investigate the Efficacy and Safety of Acoustic Cluster Therapy With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer","sponsor":"EXACT Therapeutics AS","started":"2025-06-19","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02029443","kind":"trial","name":"ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia","aka":[],"tldr":"A phase 1/2 trial of Acalabrutinib in chronic lymphocytic leukaemia, run by Acerta Pharma BV, active and no longer recruiting.","summary":"ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia is a phase 1/2 interventional study registered as NCT02029443 by Acerta Pharma BV, with 306 participants enrolled, started 2014-01-30 and due to reach its primary completion in 2021-07-15. Interventions recorded: Acalabrutinib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02029443","url":"https://clinicaltrials.gov/study/NCT02029443"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","richter-transformation-cll"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["acalabrutinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02029443","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open-label, and Dose-escalation Study of ACP-196 in Subjects With Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia","sponsor":"Acerta Pharma BV","started":"2014-01-30","startedType":"actual","yearReported":2022,"enrolled":306,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1","primary":true,"unit":"participants","arms":[{"name":"Cohort 1","n":9,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-09-10), not from a publication"},{"name":"Cohort 2a","n":8,"value":0},{"name":"Cohort 2b","n":29,"value":0},{"name":"Cohort 3","n":7,"value":0},{"name":"Cohort 4a","n":6,"value":0},{"name":"Cohort 4b","n":6,"value":0}],"source":"https://clinicaltrials.gov/study/NCT02029443?tab=results"}]},{"id":"act-ii","kind":"trial","name":"ACT II","aka":[],"tldr":"ACT II, the largest anal cancer trial, confirmed mitomycin-fluorouracil chemoradiation as the standard, showed that swapping in cisplatin or adding maintenance chemotherapy gave nothing, and taught doctors to wait six months before judging response.","summary":"ACT II randomised 940 patients with anal squamous cell carcinoma in a two-by-two design to mitomycin or cisplatin with fluorouracil during 50.4 Gy radiotherapy, and to two cycles of maintenance cisplatin-fluorouracil or none. Complete response at 26 weeks was about 90 percent in both chemotherapy arms and progression-free survival did not differ with maintenance (James and colleagues, Lancet Oncology 2013). The trial also showed that responses continue for months after chemoradiation, so assessment should wait 26 weeks before surgery is considered.","status":"positive","asOf":"2026-09-17","links":[{"label":"ISRCTN26715889","url":"https://www.isrctn.com/ISRCTN26715889"},{"label":"Lancet Oncology 2013","url":"https://doi.org/10.1016/S1470-2045(13)70086-X"}],"tags":["radiation-wave4"],"related":[],"cancers":["anal","localised-anal-cancer"],"sections":[],"technologies":["imrt-igrt","radiosensitisers"],"targets":[],"drugs":["mitomycin","cisplatin","fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":["chemoradiation"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Squamous cell carcinoma of the anus: mitomycin versus cisplatin with fluorouracil chemoradiation, and maintenance chemotherapy versus none","sponsor":"Cancer Research UK","result":"Complete response about 90% with either mitomycin or cisplatin; no benefit from maintenance chemotherapy.","yearReported":2013,"enrolled":940,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response at 26 weeks","primary":true,"unit":"%","arms":[{"name":"Mitomycin + fluorouracil + radiotherapy","n":432,"value":90.5},{"name":"Cisplatin + fluorouracil + radiotherapy","n":431,"value":89.6}],"p":"0.64","source":"https://doi.org/10.1016/S1470-2045(13)70086-X"},{"endpoint":"Progression-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Maintenance fluorouracil-cisplatin","n":448,"value":74},{"name":"No maintenance","n":492,"value":73}],"hr":0.95,"ci":[0.75,1.21],"p":"0.70","source":"https://doi.org/10.1016/S1470-2045(13)70086-X"}]},{"id":"act-iv","kind":"trial","name":"ACT IV","aka":[],"tldr":"ACT IV was a double-blind phase 3 test of rindopepimut, a vaccine against the EGFRvIII mutant protein, in 745 patients with newly diagnosed glioblastoma. It showed no benefit over a control vaccine, and because both arms beat historical expectations it taught the field how misleading historical-control comparisons can be.","summary":"ACT IV, trial NCT01480479 sponsored by Celldex Therapeutics and reported in 2016, was a double-blind test of the EGFRvIII vaccine rindopepimut in newly diagnosed glioblastoma with minimal residual disease that showed no benefit, and it taught the field how misleading historical-control comparisons can be. It randomised 745 patients to rindopepimut or a control vaccine with temozolomide and found no difference in overall survival, while both arms outperformed historical expectations and EGFRvIII was lost at recurrence in most patients whichever arm they were in. OnCo links it to EGFR as a target, the EGFRvIII term, rindopepimut and the brain as a bottleneck, and the trial failed to replicate the phase 2 ACT III signal. Whether a single-antigen vaccine can ever work against a target the tumour so readily discards is the question its failure answered in the negative.","status":"negative","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT01480479","url":"https://clinicaltrials.gov/study/NCT01480479"}],"tags":[],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["shared-antigen-vaccine"],"targets":["egfr"],"drugs":["rindopepimut"],"companies":["celldex"],"institutions":[],"pathways":[],"terms":["egfrviii"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01480479","phase":"3","setting":"Newly diagnosed EGFRvIII+ glioblastoma with minimal residual disease: rindopepimut + temozolomide vs control (KLH) + temozolomide","sponsor":"Celldex Therapeutics","result":"OS 20.1 vs 20.0 months; no benefit.","started":"2011-11","yearReported":2016,"enrolled":745,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, minimal residual disease population","primary":true,"unit":"months","arms":[{"name":"Rindopepimut + temozolomide","n":371,"value":20.1,"note":"Not significant"},{"name":"Control + temozolomide","n":374,"value":20}],"hr":1.01,"ci":[0.79,1.3],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30517-X/fulltext"}],"replication":"Failed to replicate the phase 2 ACT III signal; EGFRvIII loss at recurrence in both arms undermined the target."},{"id":"act-in-sarc","kind":"trial","name":"Act.In.Sarc","aka":["NBTXR3-301","ActInSarc"],"tldr":"Act.In.Sarc showed that injecting hafnium oxide nanoparticles into a soft-tissue sarcoma before preoperative radiotherapy roughly doubled the share of patients whose tumour, once removed, had almost no surviving cancer cells, and that result supported the product's European CE mark in 2019.","summary":"Act.In.Sarc (study NBTXR3-301) was an open-label, randomised, multicentre phase 2/3 trial of NBTXR3, a hafnium oxide nanoparticle radioenhancer injected once into the tumour, in adults with locally advanced soft-tissue sarcoma of the extremity or trunk wall who needed preoperative radiotherapy. 180 eligible patients were randomised 1:1, stratified by histological subtype (myxoid liposarcoma versus others), to NBTXR3 (an injection volume equal to 10 percent of the baseline tumour volume, at 53.3 g/L) followed by external-beam radiotherapy of 50 Gy in 25 fractions, or to the same radiotherapy alone; both arms then had surgery. The primary endpoint was pathological complete response, judged by a central pathology review board under EORTC guidelines in the intention-to-treat full analysis set.\n\nOf 179 patients who started treatment, 176 were analysed for the primary endpoint (87 NBTXR3, 89 radiotherapy alone) after three were found to be ineligible. Pathological complete response occurred in 14 of 87 patients (16 percent) with NBTXR3 and 7 of 89 (8 percent) with radiotherapy alone (p=0.044; The Lancet Oncology 2019). Postoperative wound complication was the most common grade 3 or 4 treatment-emergent event in both arms (9 percent each). Injection-site pain and hypotension (4 percent each) were the most common grade 3 or 4 events related to NBTXR3 administration; serious adverse events occurred in 39 percent versus 30 percent, and there were no treatment-related deaths.\n\nThe final safety and quality-of-life report (International Journal of Radiation Oncology, Biology, Physics 2022) restated the primary result as 16.1 versus 7.9 percent, reported more R0 resections with NBTXR3 (77.0 versus 64.0 percent), and found no negative effect on safety or quality of life over at least two years of follow-up. NBTXR3 carries a European CE mark, as Hensify, for this indication since 2019.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02379845","url":"https://clinicaltrials.gov/study/NCT02379845"},{"label":"The Lancet Oncology 2019","url":"https://doi.org/10.1016/S1470-2045(19)30326-2"},{"label":"International Journal of Radiation Oncology, Biology, Physics 2022 (final safety and quality of life)","url":"https://doi.org/10.1016/j.ijrobp.2022.07.001"}],"tags":[],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":["radiosensitisers"],"targets":[],"drugs":["nbtxr3"],"companies":["nanobiotix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sylvie-bonvalot"],"bottlenecks":[],"keyPapers":["paper-act-in-sarc-lancet-oncol-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02379845","phase":"2/3","setting":"Locally advanced soft-tissue sarcoma of the extremity or trunk wall needing preoperative radiotherapy: a single intratumoural injection of NBTXR3 before 50 Gy in 25 fractions, against the same radiotherapy alone, then surgery in both arms","sponsor":"Nanobiotix","result":"Pathological complete response 16% (14 of 87) with NBTXR3 plus radiotherapy versus 8% (7 of 89) with radiotherapy alone (p=0.044).","started":"2015-03-03","startedType":"actual","yearReported":2019,"enrolled":180,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathological complete response (central review, EORTC guidelines)","primary":true,"unit":"%","arms":[{"name":"NBTXR3 plus radiotherapy","n":87,"value":16,"note":"14 of 87; intention-to-treat full analysis set"},{"name":"Radiotherapy alone","n":89,"value":8,"note":"7 of 89"}],"p":"0.044","source":"https://doi.org/10.1016/S1470-2045(19)30326-2"}]},{"id":"nct03686124","kind":"trial","name":"ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors","aka":["ACTengine"],"tldr":"A phase 1/2 trial of Nivolumab in advanced solid tumours, run by Immatics US, Inc., now recruiting.","summary":"ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors is a phase 1/2 interventional study registered as NCT03686124 by Immatics US, Inc., with 375 participants planned, started 2019-05-14 and due to reach its primary completion in 2028-12. Interventions recorded: IMA203 Product, IMA203 product- flat dose, IMA203CD8 Product, Nivolumab and IMADetect®.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03686124","url":"https://clinicaltrials.gov/study/NCT03686124"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["immatics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03686124","phase":"1/2","setting":"Phase 1/2 Study Evaluating Genetically Modified Autologous T Cells Expressing a TCR Recognizing a Cancer/Germline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and/or Refractory Solid Tumors","sponsor":"Immatics US, Inc.","started":"2019-05-14","startedType":"actual","enrolled":375,"enrolledBasis":"registry","outcomes":[]},{"id":"actg-a5263","kind":"trial","name":"ACTG A5263/AMC 066","aka":["ACTG A5263","A5263","AMC 066"],"tldr":"ACTG A5263 tested whether two cheaper, easier chemotherapies could replace paclitaxel for people with HIV and advanced Kaposi sarcoma in Africa; both were clearly worse, so paclitaxel with antiretroviral therapy is the treatment to aim for wherever it can be supplied.","summary":"ACTG A5263/AMC 066 was a three-arm open-label randomised non-inferiority trial at sites in Kenya, Malawi, South Africa, Uganda, Zimbabwe and Brazil in 334 adults with advanced AIDS-associated Kaposi sarcoma starting antiretroviral therapy (efavirenz, emtricitabine and tenofovir). Patients were randomised to paclitaxel, oral etoposide, or bleomycin with vincristine. The primary endpoint was progression-free survival at week 48.\n\nThe etoposide arm was closed for inferiority in 2016 and the bleomycin-vincristine arm in 2018, ending the trial early. Week-48 progression-free survival was 50 percent with paclitaxel against 20 percent with etoposide, and 64 percent with paclitaxel against 44 percent with bleomycin-vincristine; the confidence intervals excluded non-inferiority for both. Adverse events were similar across arms. The corpus's Kaposi sarcoma page cites the trial for antiretroviral therapy plus paclitaxel where available, with bleomycin-vincristine otherwise.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01435018","url":"https://clinicaltrials.gov/study/NCT01435018"}],"tags":["soc-trials"],"related":[],"cancers":["kaposi-sarcoma","vascular-tumours","sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["paclitaxel","etoposide","bleomycin","vincristine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-actg-a5263-kaposi-sarcoma-resource-limited-krown-lancet-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01435018","phase":"3","setting":"Advanced AIDS-associated Kaposi sarcoma in resource-limited settings in Africa and South America: antiretroviral therapy with paclitaxel (standard), oral etoposide or bleomycin plus vincristine, with progression-free survival at 48 weeks as the primary endpoint of a non-inferiority design","sponsor":"AIDS Clinical Trials Group (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections)","result":"Week-48 progression-free survival 50 percent with paclitaxel against 20 percent with oral etoposide, and 64 percent against 44 percent with bleomycin plus vincristine; both investigational arms were inferior and closed early.","started":"2013-10-01","startedType":"actual","yearReported":2020,"enrolled":334,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at week 48, paclitaxel against etoposide (non-inferiority)","primary":true,"unit":"%","arms":[{"name":"Paclitaxel + antiretroviral therapy","n":59,"value":50,"note":"95% CI 32 to 67"},{"name":"Oral etoposide + antiretroviral therapy","n":59,"value":20,"note":"95% CI 6 to 33; arm closed for inferiority in March 2016"}],"source":"https://doi.org/10.1016/S0140-6736(19)33222-2"},{"endpoint":"Progression-free survival at week 48, paclitaxel against bleomycin plus vincristine (non-inferiority)","primary":true,"unit":"%","arms":[{"name":"Paclitaxel + antiretroviral therapy","n":138,"value":64,"note":"95% CI 55 to 73"},{"name":"Bleomycin + vincristine + antiretroviral therapy","n":132,"value":44,"note":"95% CI 35 to 53; arm closed for inferiority in March 2018"}],"source":"https://doi.org/10.1016/S0140-6736(19)33222-2"},{"endpoint":"Absolute difference in week-48 progression-free survival, etoposide minus paclitaxel","unit":"percentage points","arms":[{"name":"Oral etoposide against paclitaxel","value":-30,"note":"95% CI -52 to -8"}],"source":"https://doi.org/10.1016/S0140-6736(19)33222-2"},{"endpoint":"Absolute difference in week-48 progression-free survival, bleomycin-vincristine minus paclitaxel","unit":"percentage points","arms":[{"name":"Bleomycin + vincristine against paclitaxel","value":-20,"note":"95% CI -33 to -7"}],"source":"https://doi.org/10.1016/S0140-6736(19)33222-2"}]},{"id":"acticca-1","kind":"trial","name":"ACTICCA-1","aka":[],"tldr":"ACTICCA-1 asks whether six months of gemcitabine and cisplatin after surgery beats the current standard for bile duct and gallbladder cancer. It recruited 789 patients across eight countries including 24 UK hospitals, has a separate gallbladder cohort, and finished recruiting; results are awaited.","summary":"ACTICCA-1 (NCT02170090) is an investigator-initiated, multinational randomised phase 3 trial led from Hamburg-Eppendorf and funded by Deutsche Krebshilfe, the Dutch Cancer Society and, for the UK sites, Cancer Research UK. Patients with histologically confirmed adenocarcinoma of the biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma, or muscle-invasive gallbladder carcinoma) after macroscopically complete resection were randomised within 16 weeks of surgery to gemcitabine and cisplatin for 24 weeks or to the standard of care, which was observation when the trial opened in 2014 and became capecitabine after BILCAP. The protocol enrolled cholangiocarcinoma and gallbladder carcinoma as two separate cohorts with their own sample sizes (271 and 154 evaluable patients) because of their different prognosis, stratified by nodal status; the primary endpoint is disease-free survival with overall survival, safety, quality of life and recurrence pattern as secondary endpoints. The registry records 789 patients enrolled at 67 sites in Australia, Austria, Denmark, Germany, Italy, the Netherlands, New Zealand and the United Kingdom, with primary completion in December 2025 and the trial active but no longer recruiting. No results were found in Europe PMC or on the registry in September 2026. For gallbladder cancer this is the only phase 3 with a dedicated cohort testing platinum doublet chemotherapy against capecitabine after surgery.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02170090","url":"https://clinicaltrials.gov/study/NCT02170090"},{"label":"Stein et al., BMC Cancer 2015: ACTICCA-1 protocol","url":"https://doi.org/10.1186/s12885-015-1498-0"}],"tags":[],"related":["bilcap"],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine-cisplatin","gemcitabine","cisplatin","capecitabine"],"companies":[],"institutions":["cruk"],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-mcclements-capbil-surgical-outcomes-gallbladder-cancer-hpb-2026"],"journals":[],"dependsOn":[],"notes":["Key facts: adjuvant gemcitabine and cisplatin for 24 weeks versus standard of care (observation, then capecitabine after BILCAP) within 16 weeks of macroscopically complete resection; two cohorts with separate sample sizes (cholangiocarcinoma 271 and muscle-invasive gallbladder carcinoma 154 evaluable) stratified by nodal status; primary endpoint disease-free survival; 789 enrolled at 67 sites in eight countries; primary completion December 2025; no results in Europe PMC or on the registry in September 2026. UK sites funded by Cancer Research UK.","UK sites (24, registry): Hampshire Hospitals (Basingstoke), Queen Elizabeth Hospital Birmingham, Royal Bournemouth Hospital, Bristol Haematology and Oncology Centre, Addenbrooke's Cambridge, Velindre Cardiff, Western General Edinburgh, Beatson Glasgow, James Paget (Great Yarmouth), Royal Surrey Guildford, Princess Alexandra Harlow, Huddersfield Royal Infirmary, Guy's and St Thomas' London and others."],"nct":"NCT02170090","phase":"3","setting":"Adjuvant gemcitabine and cisplatin for 24 weeks versus standard of care (observation, later capecitabine) after curative-intent resection of cholangiocarcinoma or muscle-invasive gallbladder carcinoma, in two separate cohorts","sponsor":"Universitätsklinikum Hamburg-Eppendorf","started":"2014-04","enrolled":789,"enrolledBasis":"registry","outcomes":[]},{"id":"action-dmg","kind":"trial","name":"ACTION","aka":[],"tldr":"ACTION is the first placebo-controlled phase 3 trial ever run in diffuse midline glioma, the childhood brain-stem tumour that radiotherapy alone has never cured. It asks whether taking dordaviprone after radiotherapy lengthens life.","summary":"Randomised, double-blind, placebo-controlled phase 3 in patients aged 2 years and older with newly diagnosed H3 K27M-mutant diffuse glioma who have completed front-line radiotherapy; participants are randomised to dordaviprone once weekly, dordaviprone on two consecutive days weekly, or placebo. Primary endpoints are overall survival and progression-free survival. Dordaviprone (ONC201) is an imipridone that antagonises DRD2 and activates the mitochondrial protease ClpP, with activity concentrated in H3 K27M-mutant tumours in earlier single-arm studies; the FDA granted accelerated approval in August 2025 for recurrent H3 K27M-mutant diffuse midline glioma on the basis of pooled single-arm response data, with ACTION as the confirmatory trial. Jazz Pharmaceuticals acquired Chimerix in 2025 and now sponsors the study. Recruiting across North America, Europe, Asia and Australia; estimated enrolment 510.","status":"recruiting","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT05580562","url":"https://clinicaltrials.gov/study/NCT05580562"},{"label":"Jazz Pharmaceuticals: dordaviprone","url":"https://www.jazzpharma.com"}],"tags":["nci-coverage","paediatric","cns"],"related":[],"cancers":["dipg-dmg"],"sections":[],"technologies":[],"targets":[],"drugs":["dordaviprone"],"companies":["jazz"],"institutions":[],"pathways":[],"terms":["h3k27m","race-for-children-act"],"trials":[],"people":[],"bottlenecks":["b-brain-delivery","b-rare-cancers"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05580562","phase":"3","setting":"Newly diagnosed H3 K27M-mutant diffuse glioma after completion of radiotherapy: dordaviprone (ONC201) vs placebo, two dosing schedules","sponsor":"Jazz Pharmaceuticals (Chimerix until 2025)","started":"2023-01-23","startedType":"actual","enrolled":510,"enrolledBasis":"registry","outcomes":[],"replication":"Single-arm phase 2 data only so far; ACTION is the confirmatory trial. Its result will also be the first randomised test of any systemic agent added to radiotherapy in this disease."},{"id":"action-1","kind":"trial","name":"ACTION-1","aka":[],"tldr":"Tests whether an actinium alpha-radioligand rescues neuroendocrine tumours after lutetium therapy fails.","summary":"ACTION-1, trial NCT05477576 sponsored by Bristol Myers Squibb through RayzeBio, tests whether the actinium-225 alpha-radioligand RYZ101, or 225Ac-DOTATATE, rescues somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumours after lutetium-177 somatostatin analogue therapy has failed. Its phase 1b established a fixed dose of 10.2 MBq with encouraging responses, the phase 3 against investigator's choice is enrolling with an interim analysis expected in 2026, and its dosimetry was published in the Journal of Nuclear Medicine in 2026. OnCo links it to targeted alpha therapy, actinium-225 DOTATATE, lutetium-177 dotatate and the pairing of beta then alpha PRRT. Whether an alpha emitter can overcome resistance to a beta emitter aimed at the same receptor is the question it will answer.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05477576","url":"https://clinicaltrials.gov/study/NCT05477576"},{"label":"ACTION-1 dosimetry (JNM 2026)","url":"https://jnm.snmjournals.org/content/67/8/1239"}],"tags":[],"related":[],"cancers":["neuroendocrine"],"sections":[],"technologies":["targeted-alpha-therapy"],"targets":[],"drugs":["ryz101","lutathera"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05477576","phase":"3","setting":"SSTR-positive GEP-NETs progressing after 177Lu somatostatin-analogue therapy: 225Ac-DOTATATE (RYZ101) vs investigator's choice","sponsor":"BMS (RayzeBio)","started":"2022-03-24","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"nct07272109","kind":"trial","name":"Active Anti-diabetic Treatment Plus Chemotherapy for Pancreatic Cancer Related Diabetes","aka":["PTCA199-16"],"tldr":"A phase 3 trial of nab-paclitaxel and gemcitabine in pancreatic cancer, run by Fudan University, not yet recruiting.","summary":"Active Anti-diabetic Treatment Plus Chemotherapy for Pancreatic Cancer Related Diabetes is a phase 3, randomised interventional study registered as NCT07272109 by Fudan University, with a registry enrolment figure of 210 participants, started 2026-01-01 and due to reach its primary completion in 2027-12-30. Interventions recorded: Nab-paclitaxel; Gemcitabine (1000 mg/m2); Anti-Diabetics; Active treatment and monitoring. Conditions listed: Pancreatic Cancer. Primary outcome: Overall Survival (OS):. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed metastatic pancreas adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07272109","url":"https://clinicaltrials.gov/study/NCT07272109"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["nab-paclitaxel","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07272109","phase":"3","setting":"Active Anti-diabetic Treatment Plus Chemotherapy for Metastatic Pancreatic Cancer Related Diabetes Mellitus (Type 3c)","sponsor":"Fudan University","started":"2026-01-01","startedType":"estimated","enrolled":210,"enrolledBasis":"registry","outcomes":[]},{"id":"actuate-1801","kind":"trial","name":"Actuate 1801 Part 3B (elraglusib)","aka":["actuate-1801","Actuate 1801","9-ING-41 in Patients With Advanced Cancers"],"tldr":"A randomised phase 2 found that adding the GSK-3 inhibitor elraglusib to standard chemotherapy lengthened survival in metastatic pancreatic cancer; a phase 3 is needed to confirm it.","summary":"Part 3B of the Actuate 1801 study randomised patients with previously untreated metastatic pancreatic ductal adenocarcinoma to gemcitabine and nab-paclitaxel with or without elraglusib. The company reported improved overall survival and one-year survival with elraglusib. As a phase 2 result it is hypothesis-generating, and Actuate has said a confirmatory phase 3 is planned. The same registration, NCT03678883 (Actuate 1801), also covers the earlier dose-finding and expansion parts, in which elraglusib was given alone or with gemcitabine, doxorubicin, lomustine, carboplatin or paclitaxel to patients with refractory solid tumours or blood cancers.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03678883","url":"https://clinicaltrials.gov/study/NCT03678883"},{"label":"Mahalingam et al., Nature Medicine 2026: elraglusib and chemotherapy in metastatic pancreatic ductal adenocarcinoma, randomised phase 2","url":"https://doi.org/10.1038/s41591-026-04327-4"},{"label":"Mahalingam et al., elraglusib randomised phase 2 (Nature Medicine 2026)","url":"https://doi.org/10.1038/s41591-026-04327-4"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["elraglusib","gemcitabine-nab-paclitaxel","gemcitabine","paclitaxel","doxorubicin","pegylated-liposomal-doxorubicin","lomustine","carboplatin"],"companies":["actuate-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-mahalingam-nat-med"],"journals":[],"dependsOn":[],"notes":["Primary paper (Nature Medicine 2026, Mahalingam et al.; data cut 27 April 2025): open-label international randomised phase 2, 2 to 1, 155 against 78 patients with untreated metastatic disease; median overall survival 10.1 against 7.2 months (hazard ratio 0.62, 0.46 to 0.84; p 0.01), one-year survival 44.1 against 22.3 percent; grade 3 or worse neutropenia 52.3 against 30.8 percent, anaemia 25.2 against 29.5, fatigue 16.8 against 5.1; baseline CXCL2 and TRAIL associated with benefit and intratumoral cytotoxic cells increased on treatment. Registry (NCT03678883): active but no longer recruiting, 350 participants (estimated), sites in the United States, Belgium, Canada, France, the Netherlands, Portugal and Spain, none in the UK. A phase 3 is planned."],"nct":"NCT03678883","phase":"2","setting":"Untreated metastatic pancreatic adenocarcinoma: gemcitabine and nab-paclitaxel with or without elraglusib","sponsor":"Actuate Therapeutics","result":"Overall survival longer with elraglusib in a randomised phase 2; confirmation pending.","started":"2019-01-04","startedType":"actual","yearReported":2025,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Elraglusib + gemcitabine-nab-paclitaxel","n":155,"value":10.1},{"name":"Gemcitabine-nab-paclitaxel","n":78,"value":7.2}],"hr":0.62,"ci":[0.46,0.84],"p":"0.01","source":"https://doi.org/10.1038/s41591-026-04327-4"},{"endpoint":"Overall survival at 1 year","primary":true,"unit":"%","arms":[{"name":"Elraglusib + gemcitabine-nab-paclitaxel","value":44.1},{"name":"Gemcitabine-nab-paclitaxel","value":22.3}],"source":"https://doi.org/10.1038/s41591-026-04327-4"},{"endpoint":"Overall survival (modified intention to treat)","primary":true,"unit":"months","arms":[{"name":"Elraglusib + gemcitabine/nab-paclitaxel","n":155,"value":10.1},{"name":"Gemcitabine/nab-paclitaxel","n":78,"value":7.2}],"hr":0.62,"ci":[0.46,0.84],"p":"0.01","source":"https://doi.org/10.1038/s41591-026-04327-4"},{"endpoint":"Overall survival at 1 year","primary":true,"unit":"%","arms":[{"name":"Elraglusib + gemcitabine/nab-paclitaxel","n":155,"value":44.1},{"name":"Gemcitabine/nab-paclitaxel","n":78,"value":22.3}],"source":"https://doi.org/10.1038/s41591-026-04327-4"}]},{"id":"nct06911333","kind":"trial","name":"AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of AD1208 in advanced solid tumours, run by Avelos Therapeutics Inc., now recruiting.","summary":"AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06911333 by Avelos Therapeutics Inc., with 36 participants planned, started 2025-03-11 and due to reach its primary completion in 2029-06-30. Interventions recorded: AD1208.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06911333","url":"https://clinicaltrials.gov/study/NCT06911333"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06911333","phase":"1/2","setting":"A Phase I/IIa Trial of AD1208, a Cell Cycle Inhibitor/MASTL Inhibitor, as a Single Agent or a Combination in Subjects With Any Progressive, Locally Advanced(Unresectable) or Metastatic Solid Tumors","sponsor":"Avelos Therapeutics Inc.","started":"2025-03-11","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06248606","kind":"trial","name":"Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases","aka":[],"tldr":"A phase 2 trial of adagrasib in lung cancer, run by Ryan Gentzler, MD, now recruiting.","summary":"Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases is a phase 2, interventional study registered as NCT06248606 by Ryan Gentzler, MD, with a registry enrolment figure of 30 participants, started 2024-08-06 and due to reach its primary completion in 2027-02-25. Interventions recorded: Adagrasib; Stereotactic Radiosurgery. Conditions listed: Non Small Cell Lung Cancer; NSCLC; KRAS G12C. Primary outcome: Intracranial disease control rate (DCR). Lung eligibility wording from the registry: \"Confirmation of stage IV non-small cell lung cancer (NSCLC) per AJCC, 8th edition, or metastatic recurrence after treatment for earlier stage disease\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06248606","url":"https://clinicaltrials.gov/study/NCT06248606"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["kras-g12c-nsclc"],"sections":[],"technologies":["kras-inhibitors","sbrt"],"targets":[],"drugs":["adagrasib"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06248606","phase":"2","setting":"Phase II Study of Adagrasib + Stereotactic Radiosurgery (SRS) for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases","sponsor":"Ryan Gentzler, MD","started":"2024-08-06","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06844422","kind":"trial","name":"Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND)","aka":["ASCEND"],"tldr":"A phase 1/2 trial of ivonescimab in pancreatic cancer, run by Shandong Cancer Hospital and Institute, now recruiting.","summary":"Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND) is a phase 1/2, interventional study registered as NCT06844422 by Shandong Cancer Hospital and Institute, with a registry enrolment figure of 37 participants, started 2025-02-08 and due to reach its primary completion in 2028-02-18. Interventions recorded: Ivonescimab. Conditions listed: Pancreatic Cancer. Primary outcome: Maximum Tolerated Dose (MTD); Dose-Limiting Toxicity (DLT); Recommended Phase 2 Dose (RP2D). Pancreatic eligibility wording from the registry: \"At least one measurable pancreatic cancer lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06844422","url":"https://clinicaltrials.gov/study/NCT06844422"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["checkpoint-inhibitor","sbrt"],"targets":[],"drugs":["ivonescimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06844422","phase":"1/2","setting":"Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND) -A Single-Arm Phase Ib/II Trial","sponsor":"Shandong Cancer Hospital and Institute","started":"2025-02-08","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06246344","kind":"trial","name":"Adaptive Boost Radiotherapy to Primary Lesions and Positive Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 3 trial of Adaptive radiotherapy in Rectal cancer, run by Shandong Cancer Hospital and Institute, active and no longer recruiting.","summary":"Adaptive Boost Radiotherapy to Primary Lesions and Positive Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer is a phase 3 interventional study registered as NCT06246344 by Shandong Cancer Hospital and Institute, with 128 participants planned, started 2023-12-01 and due to reach its primary completion in 2025-12-01. Interventions recorded: Online Adaptive Radiotherapy With Sequential Boost, Conventional Non-Adaptive IMRT, Capecitabine, CAPEOX, Total Mesorectal Excision. Conditions recorded: Rectal Cancer.\n\nLinked to the technology Adaptive radiotherapy because the registry names it (\"adaptive radiotherapy\") among its interventions and Rectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06246344","url":"https://clinicaltrials.gov/study/NCT06246344"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["adaptive-radiotherapy"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06246344","phase":"3","setting":"Online Adaptive Radiotherapy With a Boost to the Primary Tumor and Clinically Involved Lymph Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer: A Prospective, Randomized Controlled Trial","sponsor":"Shandong Cancer Hospital and Institute","started":"2023-12-01","startedType":"actual","enrolled":128,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07746388","kind":"trial","name":"Adaptive Chemotherapy for Pd-l1 High REsEctablE NSCLC: A Chemo-PHREE Trial","aka":[],"tldr":"A phase 2 trial of cemiplimab in lung cancer, run by University of Maryland, Baltimore, not yet recruiting.","summary":"Adaptive Chemotherapy for Pd-l1 High REsEctablE NSCLC: A Chemo-PHREE Trial is a phase 2, interventional study registered as NCT07746388 by University of Maryland, Baltimore, with a registry enrolment figure of 30 participants, started 2026-09-01 and due to reach its primary completion in 2030-09-01. Interventions recorded: Cemiplimab. Conditions listed: Nsclc; NSCLC Stage II; NSCLC, Stage III; NSCLC Stage IIIB; Resectable Lung Non-Small Cell Carcinoma. Primary outcome: Major pathologic response (MPR). Lung eligibility wording from the registry: \"Participants with histologically confirmed stage II-IIIB(N2) NSCLC (per the 9th International Association for the Study of Lung Cancer) with disease that is considered resectable prior to initiation of systemic therapy\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07746388","url":"https://clinicaltrials.gov/study/NCT07746388"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["pdl1-high-nsclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07746388","phase":"2","setting":"Adaptive Chemotherapy for Pd-l1 High REsEctablE NSCLC: A Chemo-PHREE Trial","sponsor":"University of Maryland, Baltimore","started":"2026-09-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07523555","kind":"trial","name":"Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies","aka":["ADAPT-HEM"],"tldr":"A phase 1/2 trial of Autologous CD19/CD22 dual-target CAR-T module in acute lymphoblastic leukaemia, non-Hodgkin lymphoma, multiple myeloma, acute myeloid leukaemia and peripheral T-cell lymphomas, run by Beijing Biotech, now recruiting.","summary":"Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies is a phase 1/2 interventional study registered as NCT07523555 by Beijing Biotech, with 96 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-03-14. Interventions recorded: Autologous CD19/CD22 dual-target CAR-T module, Autologous CD19/CD20 dual-target CAR-T module, Autologous BCMA/CD19 dual-target CAR-T module, Autologous BCMA/CD38 dual-target CAR-T module, Autologous BCMA/GPRC5D dual-target CAR-T and Autologous CD33/CD123 dual-target CAR-T module.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07523555","url":"https://clinicaltrials.gov/study/NCT07523555"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","non-hodgkin-lymphoma","multiple-myeloma","aml","peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07523555","phase":"1/2","setting":"A Phase 1/2, Open-Label, Nonrandomized, Multi-arm Umbrella Study of Biomarker-Selected Dual-Target CAR-T Cell Modules in Adults With Relapsed or Refractory Hematologic Malignancies","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":96,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06545747","kind":"trial","name":"Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Sun Yat-sen University, now recruiting.","summary":"Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI is a phase 3, randomised interventional study registered as NCT06545747 by Sun Yat-sen University, with a registry enrolment figure of 490 participants, started 2024-08-01 and due to reach its primary completion in 2028-07-31. Interventions recorded: DCE-MRI based split-course hypo-RT; CT based split-course hypo-RT; Concurrent chemotherapy; Consolidative immunotherapy. Conditions listed: Non-small Cell Lung Cancer. Primary outcome: treatment-related G2+ respiratory toxicity; progression-free survival rate. Lung eligibility wording from the registry: \"* Patients must have histological or cytological confirmation of locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06545747","url":"https://clinicaltrials.gov/study/NCT06545747"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06545747","phase":"3","setting":"A Randomized Controlled Phase III Study of Adaptive Hypofractionated Radiotherapy Combined With Concurrent Chemotherapy and Consolidative Immunotherapy in Locally Advanced Non-Small Cell Lung Cancer Based on Dynamic Enhanced Magnetic Resonance Imaging","sponsor":"Sun Yat-sen University","started":"2024-08-01","startedType":"actual","enrolled":490,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07744256","kind":"trial","name":"Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC)","aka":[],"tldr":"A phase 1/2 trial of EB-DART-NK01 in small-cell lung cancer, run by Beijing Biotech, now recruiting.","summary":"Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC) is a phase 1/2 interventional study registered as NCT07744256 by Beijing Biotech, with 60 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-02-14. Interventions recorded: EB-DART-NK01 and Lymphodepleting chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07744256","url":"https://clinicaltrials.gov/study/NCT07744256"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":["gd2","dll3"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07744256","phase":"1/2","setting":"A Phase 1/2 Adaptive Dose-Escalation and Expansion Study of Dual-Targeting Chimeric Antigen Receptor Natural Killer (CAR-NK) Cells Directed Against DLL3, CD56 (NCAM1), and/or GD2 in Adults With Relapsed/Refractory Small Cell Lung Cancer","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07480213","kind":"trial","name":"Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC)","aka":["DART-NK-SCLC"],"tldr":"A phase 1/2 trial of EB-DART-NK01 (DLL3/CD56 CAR-NK cells) in small-cell lung cancer, run by Beijing Biotech, now recruiting.","summary":"Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC) is a phase 1/2 interventional study registered as NCT07480213 by Beijing Biotech, with 60 participants planned, started 2026-02-02 and due to reach its primary completion in 2027-02-14. Interventions recorded: EB-DART-NK01 (DLL3/CD56 CAR-NK cells) and Lymphodepleting chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07480213","url":"https://clinicaltrials.gov/study/NCT07480213"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":["gd2","dll3"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07480213","phase":"1/2","setting":"A Phase 1/2 Adaptive Dose-Escalation and Expansion Study of Dual-Targeting Chimeric Antigen Receptor Natural Killer (CAR-NK) Cells Directed Against DLL3, CD56 (NCAM1), and/or GD2 in Adults With Relapsed/Refractory Small Cell Lung Cancer","sponsor":"Beijing Biotech","started":"2026-02-02","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07516210","kind":"trial","name":"Adaptive Radiotherapy for Safe Hypofractionation","aka":["ART-Hypo"],"tldr":"A phase 2 trial in colorectal cancer, run by Centre hospitalier de l'Université de Montréal (CHUM), not yet recruiting.","summary":"Adaptive Radiotherapy for Safe Hypofractionation is a phase 2, randomised interventional study registered as NCT07516210 by Centre hospitalier de l'Université de Montréal (CHUM), with a registry enrolment figure of 264 participants, started 2026-05 and due to reach its primary completion in 2030-05. Interventions recorded: Adaptive Hypofractionated Radiotherapy; Standard-of-care Radiotherapy. Conditions listed: Cancer; Endometrial Cancer; Prostate Cancer; Cervical Cancer; Rectal Cancers. Primary outcome: Physician-reported Grade 2+ toxicity. Sites: Canada. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07516210","url":"https://clinicaltrials.gov/study/NCT07516210"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07516210","phase":"2","setting":"Adaptive Radiotherapy for Safe Hypofractionation (ART-Hypo): A Bayesian Registry-Based Randomized Controlled Trial","sponsor":"Centre hospitalier de l'Université de Montréal (CHUM)","started":"2026-05","startedType":"estimated","enrolled":264,"enrolledBasis":"registry","outcomes":[]},{"id":"adaura","kind":"trial","name":"ADAURA","aka":["Adjuvant osimertinib after complete resection of EGFR-mutant lung cancer","ADAURA trial"],"tldr":"Showed a targeted pill after lung cancer surgery halves the risk of death, the first such result for a targeted therapy.","summary":"ADAURA, trial NCT02511106 sponsored by AstraZeneca and reported in 2020 with survival results in 2023, showed that three years of osimertinib after resection of stage IB to IIIA EGFR-mutant non-small-cell lung cancer halves the risk of death, the first such result for a targeted therapy. It randomised 682 patients to osimertinib or placebo, met its primary disease-free survival endpoint in stage II to IIIA disease with a very large effect, and showed an overall survival benefit at five years. OnCo links it to non-small-cell lung cancer, EGFR as a target, osimertinib, Roy S. Herbst, Yi-Long Wu, ALINA, the Chinese Thoracic Oncology Group, Guangdong Provincial People's Hospital, the FLAURA and ADAURA papers and terms on data maturity and EGFR mutation subtypes. Whether three years is the right duration is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT02511106","url":"https://clinicaltrials.gov/study/NCT02511106"},{"label":"ADAURA 8-year overall survival landmark update (Journal of Thoracic Oncology 2026)","url":"https://doi.org/10.1016/j.jtho.2026.104179"},{"label":"NICE TA1043: osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection","url":"https://www.nice.org.uk/guidance/ta1043"}],"tags":[],"related":[],"cancers":["nsclc","egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["egfr"],"drugs":["osimertinib"],"companies":["ctong"],"institutions":[],"pathways":[],"terms":[],"trials":["alina","keynote-091","nct02486718","ialt","lace-pooled-analysis"],"people":["roy-herbst","wu-yi-long"],"bottlenecks":[],"keyPapers":["paper-flaura-nejm-2018","paper-adaura-8-year-os-jto-2026"],"journals":[],"dependsOn":[],"notes":["Long-term follow-up. The exploratory landmark analysis published in the Journal of Thoracic Oncology in 2026 (data cutoff 4 May 2026) reports the longest overall survival from any global phase 3 adjuvant trial in EGFR-mutated stage IB to IIIA non-small-cell lung cancer. In the stage II to IIIA population the overall survival hazard ratio was 0.53 (95 percent confidence interval 0.38 to 0.75) and eight-year overall survival 74 percent with osimertinib against 58 percent with placebo, at a median follow-up of 92.0 against 68.5 months. In the whole stage IB to IIIA population the hazard ratio was 0.52 (0.39 to 0.71) and eight-year overall survival 79 against 64 percent. The benefit was larger for exon 19 deletions (0.45, 0.29 to 0.68) than for L858R (0.72, 0.46 to 1.11). Updated survival data were collected from 431 of the 558 patients alive at the planned final analysis; the remaining 127 stayed censored at the earlier cutoff.","In England NICE TA1043 (26 February 2025) funds adjuvant osimertinib only if it is stopped at 3 years, or earlier on recurrence or unacceptable toxicity; the trial gave it for 3 years."],"nct":"NCT02511106","phase":"3","setting":"Adjuvant osimertinib 3 years after resection of stage IB-IIIA EGFR-mutant NSCLC","sponsor":"AstraZeneca","result":"OS HR 0.49.","started":"2015-10-21","startedType":"actual","yearReported":2020,"enrolled":682,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival, stage II to IIIA","primary":true,"unit":"months","arms":[{"name":"Osimertinib","n":233,"note":"Median DFS not reached with osimertinib at the primary analysis"},{"name":"Placebo","n":237,"value":19.6}],"hr":0.17,"ci":[0.11,0.26],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2027071"},{"endpoint":"Overall survival at 5 years, stage II to IIIA","unit":"%","arms":[{"name":"Osimertinib","value":85},{"name":"Placebo","value":73}],"hr":0.49,"ci":[0.33,0.73],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2304594"},{"endpoint":"Overall survival at 5 years, stage IB to IIIA","unit":"%","arms":[{"name":"Osimertinib","value":88},{"name":"Placebo","value":78}],"hr":0.49,"ci":[0.34,0.7],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2304594"},{"endpoint":"8-year overall survival, stage II to IIIA","unit":"%","arms":[{"name":"Osimertinib","value":74,"note":"Post hoc exploratory update, data cut-off 4 May 2026"},{"name":"Placebo","value":58}],"hr":0.53,"ci":[0.38,0.75],"source":"https://doi.org/10.1016/j.jtho.2026.104179"},{"endpoint":"8-year overall survival, stage IB to IIIA","unit":"%","arms":[{"name":"Osimertinib","value":79,"note":"Post hoc exploratory update, data cut-off 4 May 2026"},{"name":"Placebo","value":64}],"hr":0.52,"ci":[0.39,0.71],"source":"https://doi.org/10.1016/j.jtho.2026.104179"}],"replication":"Single pivotal adjuvant trial with an OS benefit; consistent with the adjuvant ALK result (ALINA) and with earlier-generation adjuvant EGFR TKI trials that improved DFS."},{"id":"add-aspirin","kind":"trial","name":"Add-Aspirin","aka":[],"tldr":"Add-Aspirin is an 11,000-patient trial across four common cancers in the UK, Ireland and India asking whether cheap daily aspirin after curative treatment stops cancer coming back.","summary":"Add-Aspirin is a phase 3, double-blind, placebo-controlled trial with four parallel tumour-specific cohorts (breast, colorectal, gastro-oesophageal, prostate), each powered separately for disease-free or biochemical recurrence-free survival, with overall survival as a secondary endpoint. Recruitment ran from 2015 across more than 100 UK sites plus Ireland and India (Tata Memorial), reaching its target of around 11,000 participants; a feasibility analysis (Lancet Gastroenterology & Hepatology 2020) confirmed acceptable safety, including in older participants. Primary analyses are expected in the second half of the 2020s as events accrue. The trial's public funding and generic drug are the model for repurposing research that industry will not run; its PIK3CA-stratified analysis will be the first replication test for ALASCCA.","status":"active","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT02804815","url":"https://clinicaltrials.gov/study/NCT02804815"},{"label":"Add-Aspirin trial site","url":"https://www.addaspirintrial.org/"}],"tags":[],"related":[],"cancers":["colorectal","breast-hr-positive","gastric","esophageal","prostate"],"sections":["nutrition-lifestyle","prevention"],"technologies":["aspirin-cancer-prevention","drug-repurposing"],"targets":[],"drugs":["aspirin"],"companies":[],"institutions":["cruk","tata-memorial"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-generic-repurposing","b-funding-allocation"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02804815","phase":"3","setting":"After curative treatment for breast, colorectal, gastro-oesophageal or prostate cancer: aspirin 100 mg vs 300 mg vs placebo daily for 5 years","sponsor":"University College London / Cancer Research UK / NIHR / Tata Memorial","result":"Ongoing; primary analyses pending.","started":"2015-10","enrolled":11000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06268327","kind":"trial","name":"Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy","aka":[],"tldr":"A phase 2/3 trial of cisplatin, gemcitabine and capecitabine in triple-negative breast cancer, run by Assiut University, not yet recruiting.","summary":"Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy is a phase 2/3, randomised interventional study registered as NCT06268327 by Assiut University, with a registry enrolment figure of 30 participants, started 2024-04-30 and due to reach its primary completion in 2025-10-30. Interventions recorded: Cisplatin injection and gemcitabine; Capecitabine tablets. Conditions listed: Breast Cancer. Triple-negative eligibility wording from the registry: \"* Tumor subtype: triple negative\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06268327","url":"https://clinicaltrials.gov/study/NCT06268327"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin","gemcitabine","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06268327","phase":"2/3","setting":"Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy","sponsor":"Assiut University","started":"2024-04-30","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07802626","kind":"trial","name":"Adding Capivasertib to Standard Treatment in HR Positive, HER2 Negative Metastatic Breast Cancer Based on ctDNA Testing","aka":[],"tldr":"A phase 3 trial of Guardant Reveal in Breast cancer, run by SWOG Cancer Research Network, not yet recruiting.","summary":"Adding Capivasertib to Standard Treatment in HR Positive, HER2 Negative Metastatic Breast Cancer Based on ctDNA Testing is a phase 3 interventional study registered as NCT07802626 by SWOG Cancer Research Network, with 1084 participants planned, started 2026-10-30 and due to reach its primary completion in 2034-10-30. Interventions recorded: NSAI + CDK4/6i, NSAI + CDK4/6i + Capivasertib, Fulvestrant + CDK4/6i + Capivasertib, NSAI + CDK4/6i, Guardant Reveal. Conditions recorded: HR Positive/HER-2 Negative Breast Cancer.\n\nLinked to the drug Guardant Reveal because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07802626","url":"https://clinicaltrials.gov/study/NCT07802626"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["guardant-reveal"],"companies":["swog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07802626","phase":"3","setting":"MONITOR (Molecular Assessment and Identification of ctDNA and Optimizing Treatment for HR-positive, Her2-negative Metastatic Breast Cancer)","sponsor":"SWOG Cancer Research Network","started":"2026-10-30","startedType":"estimated","enrolled":1084,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06616584","kind":"trial","name":"Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemoth","aka":[],"tldr":"A phase 2/3 trial of cemiplimab, dexamethasone, docetaxel and ramucirumab in lung cancer, run by SWOG Cancer Research Network, now recruiting.","summary":"Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial) is a phase 2/3, randomised interventional study registered as NCT06616584 by SWOG Cancer Research Network, with a registry enrolment figure of 378 participants, started 2025-05-22 and due to reach its primary completion in 2027-12-31. Interventions recorded: Biospecimen Collection; Cemiplimab; Computed Tomography; Dexamethasone; Docetaxel; Magnetic Resonance Imaging; Ramucirumab. Conditions listed: Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8. Primary outcome: Overall survival (OS). Lung eligibility wording from the registry: \"Assignment to S1800E is determined by the LUNGMAP protocol\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06616584","url":"https://clinicaltrials.gov/study/NCT06616584"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["cemiplimab","dexamethasone","docetaxel","ramucirumab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06616584","phase":"2/3","setting":"A Randomized Phase II/III Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)","sponsor":"SWOG Cancer Research Network","started":"2025-05-22","startedType":"actual","enrolled":378,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06728072","kind":"trial","name":"Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Virginia Commonwealth University, now recruiting.","summary":"Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer is a phase 2, randomised interventional study registered as NCT06728072 by Virginia Commonwealth University, with a registry enrolment figure of 97 participants, started 2025-03-07 and due to reach its primary completion in 2035-07-01. Interventions recorded: Standard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin. Conditions listed: Colorectal Cancer; CRC. Primary outcome: Best response by analysis using Response Evaluation Criteria in Solid Tumors. Colorectal eligibility wording from the registry: \"* Diagnosis of stage IV colorectal cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06728072","url":"https://clinicaltrials.gov/study/NCT06728072"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06728072","phase":"2","setting":"Pilot Study Evaluating Microbiome Modulation Therapy (MBMT) With Ciprofloxacin, Metronidazole, and Aspirin in Addition to Standard of Care Chemotherapy in Patients Undergoing First-Line Therapy for Metastatic Colorectal Cancer","sponsor":"Virginia Commonwealth University","started":"2025-03-07","startedType":"actual","enrolled":97,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06141070","kind":"trial","name":"Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease","aka":["ANDROMEDA"],"tldr":"A phase 3 trial in lung cancer, run by Vastra Gotaland Region, now recruiting.","summary":"Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease is a phase 3, randomised interventional study registered as NCT06141070 by Vastra Gotaland Region, with a registry enrolment figure of 240 participants, started 2023-12-01 and due to reach its primary completion in 2028-12-01. Interventions recorded: Standard systemic therapy + radiotherapy; Standard systemic therapy. Conditions listed: Non Small Cell Lung Cancer. Primary outcome: Overall survival (OS). Lung eligibility wording from the registry: \"* Histological or cytological diagnosis of NSCLC\". Sites: Sweden. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06141070","url":"https://clinicaltrials.gov/study/NCT06141070"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06141070","phase":"3","setting":"Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease - An Open Label Randomized Phase III Trial Comparing Up-front Radiation in Oligometastatic Non-small Cell Lung Cancer (NSCLC) and Systemic Treatment With Systemic Treatment Alone","sponsor":"Vastra Gotaland Region","started":"2023-12-01","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07715396","kind":"trial","name":"Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer With a High Tumor Burden","aka":["High Five"],"tldr":"A phase 3 trial of tislelizumab and pembrolizumab in lung cancer, run by AIO-Studien-gGmbH, not yet recruiting.","summary":"Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer With a High Tumor Burden is a phase 3, randomised interventional study registered as NCT07715396 by AIO-Studien-gGmbH, with a registry enrolment figure of 230 participants, started 2026-10-30 and due to reach its primary completion in 2031-10-30. Interventions recorded: Tislelizumab; Tislelizumab Combined With Chemotherapy; Pembrolizumab. Conditions listed: Non-small Cell Lung Cancer Metastatic. Primary outcome: Progression-free survival. Lung eligibility wording from the registry: \"Histologically confirmed and treatment-naïve non-small cell lung cancer UICC 9th stage IV\". Sites: Germany. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07715396","url":"https://clinicaltrials.gov/study/NCT07715396"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab","pembrolizumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07715396","phase":"3","setting":"Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer With a High Tumor Burden","sponsor":"AIO-Studien-gGmbH","started":"2026-10-30","startedType":"estimated","enrolled":230,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06719336","kind":"trial","name":"Addition of Thoracic Consolidation Radiotherapy to the Maintenance Immunotherapy for ES-SCLC (STONE-001)","aka":["STONE-001"],"tldr":"A phase 3 trial in lung cancer, run by Anhui Shi, MD, not yet recruiting.","summary":"Addition of Thoracic Consolidation Radiotherapy to the Maintenance Immunotherapy for ES-SCLC (STONE-001) is a phase 3, randomised interventional study registered as NCT06719336 by Anhui Shi, MD, with a registry enrolment figure of 182 participants, started 2024-12-16 and due to reach its primary completion in 2028-12-16. Interventions recorded: High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy; atezolizumab or durvalumab. Conditions listed: Extensive-stage Small Cell Lung Cancer. Primary outcome: Overall survival (OS). Lung eligibility wording from the registry: \"Confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06719336","url":"https://clinicaltrials.gov/study/NCT06719336"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06719336","phase":"3","setting":"Addition of High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy to the Maintenance Therapy with PD-L1 Inhibitor Versus PD-L1 Inhibitor Alone for Extensive Stage Small Cell Lung Cancer (STONE-001)","sponsor":"Anhui Shi, MD","started":"2024-12-16","startedType":"estimated","enrolled":182,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06531278","kind":"trial","name":"Adebelimab Combined With Irinotecan Liposomal Injection, Oxaliplatin, Fluorouracil and Calcium Folinate Are Used in the First-line Treatment of Pancreatic Cance","aka":[],"tldr":"A phase 2 trial of adebrelimab, cAPOX (capecitabine, oxaliplatin), fluorouracil (5-FU) and leucovorin (folinic acid) in pancreatic cancer, run by Jiang Long, now recruiting.","summary":"Adebelimab Combined With Irinotecan Liposomal Injection, Oxaliplatin, Fluorouracil and Calcium Folinate Are Used in the First-line Treatment of Pancreatic Cancer Liver Metastasis Efficacy and Safety is a phase 2, interventional study registered as NCT06531278 by Jiang Long, with a registry enrolment figure of 40 participants, started 2024-07-16 and due to reach its primary completion in 2026-12-31. Interventions recorded: Irinotecan liposome; Adebrelimab; Oxaliplatin; Fluorouracil; Calcium folinate. Conditions listed: Pancreatic Cancer Metastatic to Liver. Primary outcome: ORR. Pancreatic eligibility wording from the registry: \"Histologically confirmed pancreatic cancer liver metastases and no previous treatment of any systemic anti-swelling tumor treatment\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06531278","url":"https://clinicaltrials.gov/study/NCT06531278"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["adebrelimab","capox","fluorouracil","leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06531278","phase":"2","setting":"Adebelimab Combined With Irinotecan Liposomal Injection, Oxaliplatin, Fluorouracil and Calcium Folinate Are Used in the First-line Treatment of Pancreatic Cancer Liver Metastasis Efficacy and Safety","sponsor":"Jiang Long","started":"2024-07-16","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06475209","kind":"trial","name":"Adebrelimab + Apatinib in SCLC Maintenance Therapy","aka":[],"tldr":"A phase 2 trial of adebrelimab and rivoceranib (apatinib) in lung cancer, run by Tang-Du Hospital, now recruiting.","summary":"Adebrelimab + Apatinib in SCLC Maintenance Therapy is a phase 2, interventional study registered as NCT06475209 by Tang-Du Hospital, with a registry enrolment figure of 60 participants, started 2024-06-20 and due to reach its primary completion in 2025-12-20. Interventions recorded: Adebrelimab combined with Apatinib. Conditions listed: SCLC. Primary outcome: Progression-free survival. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed extensive-stage small cell lung cancer (LS-SCLC) according to the AJCC 8th edition or VALG phase II staging criteria\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06475209","url":"https://clinicaltrials.gov/study/NCT06475209"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["adebrelimab","rivoceranib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06475209","phase":"2","setting":"Observational Study on the Efficacy and Safety of Adebrelimab Combined With Apatinib in Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer","sponsor":"Tang-Du Hospital","started":"2024-06-20","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06584227","kind":"trial","name":"Adebrelimab and Chidamide for Pancreatic Cancer","aka":["ACPC"],"tldr":"A phase 2 trial of adebrelimab and gemcitabine in pancreatic cancer, run by Liu Xiufeng, now recruiting.","summary":"Adebrelimab and Chidamide for Pancreatic Cancer is a phase 2, interventional study registered as NCT06584227 by Liu Xiufeng, with a registry enrolment figure of 45 participants, started 2024-09-10 and due to reach its primary completion in 2026-07-10. Interventions recorded: Adebrelimab and Chidamide Combined with Gemcitabine and S1. Conditions listed: Pancreatic Cancer, Adult. Primary outcome: Progression free survival. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed pancreatic cancer (originating from the ductal epithelium of the pancreas) with clinically documented unresectable locally advanced or metastatic pancreatic cancer (stage III/IV according to the TNM stage of AJCC 8 pancreatic cancer);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06584227","url":"https://clinicaltrials.gov/study/NCT06584227"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["adebrelimab","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06584227","phase":"2","setting":"A Single-Arm, Multicenter, Open, Phase II Clinical Study of Adebrelimab and Chidamide in Combination With Gemcitabine and S1 for the First-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer","sponsor":"Liu Xiufeng","started":"2024-09-10","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06916975","kind":"trial","name":"Adebrelimab Combined With AG Regimen in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer","aka":["CSPAC-48"],"tldr":"A phase 2 trial of adebrelimab in pancreatic cancer, run by Jin Xu, not yet recruiting.","summary":"Adebrelimab Combined With AG Regimen in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT06916975 by Jin Xu, with a registry enrolment figure of 46 participants, started 2025-04-15 and due to reach its primary completion in 2027-12-01. Interventions recorded: Adebrelimab; AG. Conditions listed: Pancreatic Cancer Non-resectable; Pancreatic Cancer Metastatic. Primary outcome: ORR. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed pancreatic cancer；\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06916975","url":"https://clinicaltrials.gov/study/NCT06916975"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06916975","phase":"2","setting":"A Prospective, Single-Arm, Phase II Clinical Trial of Adebrelimab Combined With AG Regimen in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer","sponsor":"Jin Xu","started":"2025-04-15","startedType":"estimated","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07560358","kind":"trial","name":"Adebrelimab Combined With Chemoradiotherapy in Patients With Large Bulky Stage III Unresectable Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, not yet recruiting.","summary":"Adebrelimab Combined With Chemoradiotherapy in Patients With Large Bulky Stage III Unresectable Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT07560358 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 204 participants, started 2026-05-01 and due to reach its primary completion in 2029-12-31. Interventions recorded: After chemoimmunotherapy induction, followed by concurrent/sequential chemoradiotherapy and subsequent immune consolidation and maintenance therapy.; adebrelimab,Radiation Therapy,Radiotherapy. Conditions listed: NSCLC (Advanced Non-small Cell Lung Cancer). Primary outcome: Progression-Free Survival (PFS). Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07560358","url":"https://clinicaltrials.gov/study/NCT07560358"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07560358","phase":"3","setting":"A Randomized Controlled Clinical Study of Adebrelimab Combined With Chemoradiotherapy in Patients With Large Bulky Stage III Unresectable Non-Small Cell Lung Cancer","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2026-05-01","startedType":"estimated","enrolled":204,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06672133","kind":"trial","name":"Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC","aka":["RALLY"],"tldr":"A phase 3 trial of adebrelimab in lung cancer, run by Jinming Yu, not yet recruiting.","summary":"Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC is a phase 3, randomised interventional study registered as NCT06672133 by Jinming Yu, with a registry enrolment figure of 524 participants, started 2024-12 and due to reach its primary completion in 2029-06. Interventions recorded: Adebrelimab; Radiation Therapy. Conditions listed: Extensive Stage Lung Small Cell Carcinoma. Primary outcome: PFS; OS. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed extensive stage small cell lung cancer (according to the Veterans Lung Administration Lung Study Group, VALG stage);\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06672133","url":"https://clinicaltrials.gov/study/NCT06672133"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06672133","phase":"3","setting":"Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC: a Randomized Controlled Phase III Clinical Study","sponsor":"Jinming Yu","started":"2024-12","startedType":"estimated","enrolled":524,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06177522","kind":"trial","name":"Adebrelimab Combined With Chemotherapy for Neoadjuvant Therapy in Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of adebrelimab, nab-paclitaxel and gemcitabine in pancreatic cancer, run by Jinling Hospital, China, not yet recruiting.","summary":"Adebrelimab Combined With Chemotherapy for Neoadjuvant Therapy in Resectable Pancreatic Cancer is a phase 2, interventional study registered as NCT06177522 by Jinling Hospital, China, with a registry enrolment figure of 30 participants, started 2025-11-30 and due to reach its primary completion in 2027-12-30. Interventions recorded: Adebrelimab; albumin-bound paclitaxel; Gemcitabine. Conditions listed: Pancreatic Cancer; Neoadjuvant Therapy. Primary outcome: R0 removal rate; pCR rate. Pancreatic eligibility wording from the registry: \"Patients with resectable pancreatic adenocarcinoma confirmed by histopathology or cytology (CA19-9 \\> 150 U/ml);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06177522","url":"https://clinicaltrials.gov/study/NCT06177522"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["adebrelimab","nab-paclitaxel","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06177522","phase":"2","setting":"A Single-arm, Single-center, Exploratory Study of Adebrelimab Combined With Chemotherapy for Neoadjuvant Therapy in Resectable Pancreatic Cancer","sponsor":"Jinling Hospital, China","started":"2025-11-30","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07392541","kind":"trial","name":"Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 1/2 trial of adebrelimab, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by Tongji Hospital, now recruiting.","summary":"Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer is a phase 1/2 interventional study registered as NCT07392541 by Tongji Hospital, with a registry enrolment figure of 29 participants, started 2026-01-30 and due to reach its primary completion in 2028-01-30. Interventions recorded: Adebrelimab, Gemcitabine + Cisplatin, Simvastatin 20mg. Conditions listed: Advanced Biliary Tract Carcinoma. Gallbladder cancer is named in the registry entry: \"* Histologically confirmed unresectable, locally advanced, or metastatic biliary tract adenocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer).\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07392541","url":"https://clinicaltrials.gov/study/NCT07392541"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["adebrelimab","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07392541","phase":"1/2","setting":"A Single-Arm, Multicenter, Exploratory Clinical Study of Adebrelimab in Combination With Gemcitabine, Cisplatin, and Simvastatin for the Treatment of Patients With Locally Advanced or Metastatic Biliary Tract Malignancies","sponsor":"Tongji Hospital","started":"2026-01-30","startedType":"actual","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07230301","kind":"trial","name":"Adebrelimab Infusion Plus Standard Care for Pancreatic Cancer With Pleural or Peritoneal Effusions","aka":[],"tldr":"A phase 2 trial of adebrelimab in pancreatic cancer, run by Sizhen Wang, not yet recruiting.","summary":"Adebrelimab Infusion Plus Standard Care for Pancreatic Cancer With Pleural or Peritoneal Effusions is a phase 2, interventional study registered as NCT07230301 by Sizhen Wang, with a registry enrolment figure of 20 participants, started 2025-11-30 and due to reach its primary completion in 2027-06-30. Interventions recorded: Adebrelimab (PD-L1 inhibitor). Conditions listed: Pancreatic Cancer Metastatic. Primary outcome: Overall Survival (OS). Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed pancreatic cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07230301","url":"https://clinicaltrials.gov/study/NCT07230301"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07230301","phase":"2","setting":"Intracavitary Infusion of Adebrelimab Combined With the Best Standard Treatment for the Treatment of Pancreatic Cancer With Pleural and Peritoneal Effusions: A Single-Center, Prospective, Clinical Trial","sponsor":"Sizhen Wang","started":"2025-11-30","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06765616","kind":"trial","name":"Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Feng Tian, now recruiting.","summary":"Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT06765616 by Feng Tian, with a registry enrolment figure of 31 participants, started 2024-01-01 and due to reach its primary completion in 2025-07-01. Interventions recorded: Adebrelimab Injection combined with radiotherapy and chemotherapy. Conditions listed: Rectal Cancer; Advanced Stage Colorectal Cancer; Radiotherapy. Primary outcome: Pathological complete remission rate (pCR). Colorectal eligibility wording from the registry: \"Patients diagnosed with rectal adenocarcinoma through primary lesion biopsy and histopathological examination;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06765616","url":"https://clinicaltrials.gov/study/NCT06765616"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06765616","phase":"2","setting":"Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer: a Multicenter, Single Arm Prospective Study","sponsor":"Feng Tian","started":"2024-01-01","startedType":"actual","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07561775","kind":"trial","name":"Adebrelimab Plus S-1 for Resected Cholangiocarcinoma","aka":[],"tldr":"A phase 2 trial of adebrelimab and S-1 in gallbladder cancer and other biliary tract cancers, run by Xingjun Guo, not yet recruiting.","summary":"Adebrelimab Plus S-1 for Resected Cholangiocarcinoma is a phase 2 interventional study registered as NCT07561775 by Xingjun Guo, with a registry enrolment figure of 40 participants, started 2026-04-21 and due to reach its primary completion in 2028-01-01. Interventions recorded: Adebrelimab, S-1. Conditions listed: Cholangiocarcinoma, Biliary Tract Cancer. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07561775","url":"https://clinicaltrials.gov/study/NCT07561775"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["adebrelimab","tegafur-gimeracil-oteracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07561775","phase":"2","setting":"A Single-Arm, Exploratory Clinical Study of Adebrelimab Combined With S-1 in Patients With Resected Cholangiocarcinoma","sponsor":"Xingjun Guo","started":"2026-04-21","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05405595","kind":"trial","name":"ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ADG126, Pembrolizumab, Bevacizumab, Trifluridine/tipiracil and Fruquintinib in advanced solid tumours, run by Adagene Inc, now recruiting.","summary":"ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05405595 by Adagene Inc, with 186 participants planned, started 2022-06-15 and due to reach its primary completion in 2026-10-31. Interventions recorded: ADG126, Pembrolizumab (KEYTRUDA®), Standard of Care (Trifluridine/Tipiracil-Bevacizumab) and Standard of care (Fruquintinib).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05405595","url":"https://clinicaltrials.gov/study/NCT05405595"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adg126","pembrolizumab","bevacizumab","trifluridine-tipiracil","fruquintinib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05405595","phase":"1/2","setting":"A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of ADG126 in Combination With Pembrolizumab (Anti PD-1 Antibody) in Patients With Advanced/Metastatic Solid Tumors","sponsor":"Adagene Inc","started":"2022-06-15","startedType":"actual","enrolled":186,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04587830","kind":"trial","name":"ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme","aka":[],"tldr":"A phase 2 trial of Temozolomide in glioma & glioblastoma, run by Polaris Group, active and no longer recruiting.","summary":"ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme is a phase 2 interventional study registered as NCT04587830 by Polaris Group, with 100 participants enrolled, started 2020-09-14 and due to reach its primary completion in 2027-02-28. Interventions recorded: ADI-PEG 20, Temozolomide and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04587830","url":"https://clinicaltrials.gov/study/NCT04587830"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":["polaris-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04587830","phase":"2","setting":"Phase 1-2 Trial of ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma Multiforme (GBM)","sponsor":"Polaris Group","started":"2020-09-14","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"adiuvo","kind":"trial","name":"ADIUVO","aka":["ADIUVO trial"],"tldr":"ADIUVO asked whether people whose low-grade adrenal cancer had been fully removed should take the toxic drug mitotane for two years to prevent recurrence; recurrence and survival were no different from watching and waiting, so observation with regular scans is the standard for this group.","summary":"ADIUVO was an international open-label randomised phase 3 trial with a parallel observational study, run by the University of Turin with the ENSAT network, in patients with completely resected adrenocortical carcinoma at low to intermediate risk of recurrence. Patients were randomised to adjuvant mitotane for at least two years or active surveillance; the primary endpoint was recurrence-free survival. Slow recruitment closed the trial after 91 randomised patients.\n\nFive-year recurrence-free survival was 79 percent with mitotane against 75 percent with surveillance (hazard ratio 0.74, not significant) and five-year overall survival 95 against 86 percent with two and five deaths respectively; every patient on mitotane had adverse events and 19 percent stopped treatment. The corpus's localised adrenocortical carcinoma page cites ADIUVO for observation rather than mitotane in low-risk disease, and ADIUVO-2 now tests intensified adjuvant treatment in high-risk disease.","status":"negative","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00777244","url":"https://clinicaltrials.gov/study/NCT00777244"}],"tags":["soc-trials"],"related":[],"cancers":["localised-adrenocortical-carcinoma","adrenocortical"],"sections":[],"technologies":[],"targets":[],"drugs":["mitotane"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-adiuvo-adjuvant-mitotane-low-grade-acc-terzolo-lancet-diabetes-endocrinol-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00777244","phase":"3","setting":"Completely resected adrenocortical carcinoma at low to intermediate risk of recurrence (stage I to III, R0, Ki67 10 percent or less) at 23 centres in seven countries: adjuvant mitotane for at least two years against surveillance, with recurrence-free survival as the primary endpoint","sponsor":"University of Turin, Italy","result":"Five-year recurrence-free survival 79 percent with adjuvant mitotane against 75 percent with surveillance (hazard ratio 0.74, 95% CI 0.30 to 1.85); overall survival not significantly different; adverse events in every mitotane patient.","started":"2008-04","yearReported":2023,"enrolled":91,"enrolledBasis":"randomised","enrolledNote":"The registry gives an estimated 200 and was never updated; the Lancet Diabetes and Endocrinology report randomised 91 patients (45 mitotane, 46 surveillance) between 2008 and 2018 before the trial closed for slow recruitment, alongside an observational cohort of 95.","outcomes":[{"endpoint":"Recurrence-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Adjuvant mitotane","n":45,"value":79,"note":"95% CI 67 to 94"},{"name":"Surveillance","n":46,"value":75,"note":"95% CI 63 to 90"}],"hr":0.74,"ci":[0.3,1.85],"source":"https://doi.org/10.1016/S2213-8587(23)00193-6"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Adjuvant mitotane","n":45,"value":95,"note":"95% CI 89 to 100; 2 deaths"},{"name":"Surveillance","n":46,"value":86,"note":"95% CI 74 to 100; 5 deaths"}],"source":"https://doi.org/10.1016/S2213-8587(23)00193-6"},{"endpoint":"Discontinuation of mitotane for adverse events","unit":"%","arms":[{"name":"Adjuvant mitotane","n":42,"value":19,"note":"All 42 treated patients had adverse events; no grade 4 events"}],"source":"https://doi.org/10.1016/S2213-8587(23)00193-6"}]},{"id":"adiuvo-2","kind":"trial","name":"ADIUVO-2","aka":["ADIUVO 2","ADIUVO-2 trial"],"tldr":"ADIUVO-2 tests whether adding platinum chemotherapy to mitotane after surgery lowers the high relapse rate of aggressive adrenal cancers; it is still recruiting through MD Anderson and the ENSAT network.","summary":"ADIUVO-2 is an international randomised registry trial led by MD Anderson Cancer Center with the National Cancer Institute in patients with localised adrenocortical carcinoma at high risk of recurrence after complete resection. Patients are randomised to adjuvant mitotane alone or mitotane with four cycles of cisplatin and etoposide; the primary endpoint is recurrence-free survival at two years, with local and distant recurrence as further primary measures.\n\nThe registry lists an estimated 240 participants, recruiting, with primary completion in 2029 and no results. The corpus's localised adrenocortical carcinoma page cites ADIUVO-2 for considering adjuvant chemotherapy in very high-risk tumours.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03583710","url":"https://clinicaltrials.gov/study/NCT03583710"}],"tags":["soc-trials"],"related":[],"cancers":["localised-adrenocortical-carcinoma","adrenocortical"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["mitotane","cisplatin","etoposide"],"companies":[],"institutions":["md-anderson"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03583710","phase":"3","setting":"Completely resected adrenocortical carcinoma at high risk of recurrence (Ki67 above 10 percent or stage III): a randomised registry trial of adjuvant mitotane alone against mitotane with cisplatin and etoposide, with recurrence-free survival as the primary endpoint","sponsor":"M.D. Anderson Cancer Center","started":"2018-08-20","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06041776","kind":"trial","name":"Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations","aka":[],"tldr":"A phase 3 trial of Icotinib in non-small-cell lung cancer and small-cell lung cancer, run by Betta Pharmaceuticals Co., Ltd., now recruiting.","summary":"Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations is a phase 3 interventional study registered as NCT06041776 by Betta Pharmaceuticals Co., Ltd., with 570 participants planned, started 2023-03-28 and due to reach its primary completion in 2028-04-30. Interventions recorded: Befotertinib + Icotinib placebo, Icotinib + Befotertinib placebo. Conditions listed: Non-Small Cell Lung Cancer, EGFR Sensitive Mutation, Adjuvant Therapy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06041776","url":"https://clinicaltrials.gov/study/NCT06041776"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["icotinib"],"companies":["betta"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06041776","phase":"3","setting":"A Multicenter, Randomized, Controlled, Double Blind, Double Simulated, Phase III Clinical Study of Befotertinib vs Icotinib for Postoperative Adjuvant Treatment of IB-IIIB (T3N2M0) Stage Non Small Cell Lung Cancer With Positive EGFR Sensitive Mutations","sponsor":"Betta Pharmaceuticals Co., Ltd.","started":"2023-03-28","startedType":"actual","enrolled":570,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06427447","kind":"trial","name":"Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC)","aka":["ADJUPANC"],"tldr":"A phase 3 trial in pancreatic cancer, run by Changhai Hospital, now recruiting.","summary":"Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC) is a phase 3, randomised interventional study registered as NCT06427447 by Changhai Hospital, with a registry enrolment figure of 770 participants, started 2024-08-06 and due to reach its primary completion in 2028-06-30. Interventions recorded: Adjuvant chemoradiotherapy; Adjuvant chemotherapy. Conditions listed: Pancreatic Cancer. Primary outcome: Disease progression free survival will be determined.. Pancreatic eligibility wording from the registry: \"* Pathologically confirmed pancreatic ductal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06427447","url":"https://clinicaltrials.gov/study/NCT06427447"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06427447","phase":"3","setting":"Adjuvant Chemoradiotherapy Versus Chemotherapy for Post-operative Pancreatic Cancer","sponsor":"Changhai Hospital","started":"2024-08-06","startedType":"actual","enrolled":770,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07149363","kind":"trial","name":"Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Alliance Foundation Trials, LLC., now recruiting.","summary":"Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer is a phase 2, interventional study registered as NCT07149363 by Alliance Foundation Trials, LLC., with a registry enrolment figure of 65 participants, started 2026-02-12 and due to reach its primary completion in 2029-02. Interventions recorded: Durvalumab 50 MG/ML. Conditions listed: Small Cell Lung Cancer (SCLC). Primary outcome: Disease free survival (DFS). Lung eligibility wording from the registry: \"* Must have histologically or cytologically confirmed diagnosis of pathologic T1-T2 N0-1 M0 small-cell lung cancer per the American Joint Committee on Cancer staging system, 8th edition\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07149363","url":"https://clinicaltrials.gov/study/NCT07149363"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07149363","phase":"2","setting":"Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer","sponsor":"Alliance Foundation Trials, LLC.","started":"2026-02-12","startedType":"actual","enrolled":65,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05825443","kind":"trial","name":"Adjuvant Chemotherapy Combined With Camrelizumab for IIA -IIIA NSCLC Patients","aka":["PANORAMA"],"tldr":"A phase 2 trial of camrelizumab in lung cancer, run by Nanfang Hospital, Southern Medical University, now recruiting.","summary":"Adjuvant Chemotherapy Combined With Camrelizumab for IIA -IIIA NSCLC Patients is a phase 2, interventional study registered as NCT05825443 by Nanfang Hospital, Southern Medical University, with a registry enrolment figure of 57 participants, started 2023-04-10 and due to reach its primary completion in 2026-04-01. Interventions recorded: Camrelizumab. Conditions listed: Immunotherapy; Chemotherapy. Primary outcome: Two-years disease free survival (2y-DFS). Lung eligibility wording from the registry: \"For patients with non-small cell lung cancer who have undergone surgical resection, the TNM stage after surgery is IIA-IIIA;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05825443","url":"https://clinicaltrials.gov/study/NCT05825443"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["camrelizumab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05825443","phase":"2","setting":"Efficacy and Safety of Postoperative Adjuvant Chemotherapy Combined With Camrelizumab for Patients With IIA -IIIA Non-small Cell Lung Cancer：a Phase II , Single-arm Clinical Study","sponsor":"Nanfang Hospital, Southern Medical University","started":"2023-04-10","startedType":"actual","enrolled":57,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05797467","kind":"trial","name":"Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients","aka":[],"tldr":"A phase 3 trial of bevacizumab (glioblastoma use) in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients is a phase 3, randomised interventional study registered as NCT05797467 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 366 participants, started 2023-04-01 and due to reach its primary completion in 2030-04-01. Interventions recorded: FOLFOX chemotherapy regimens; Bevacizumab. Conditions listed: Colorectal Cancer; Chemotherapy Effect. Primary outcome: 3-year disease-free survival; 5-year disease-free survival; median of disease-free survival. Colorectal eligibility wording from the registry: \"Pathologically confirmed pT3-4N2 stage colorectal adenocarcinoma after surgery;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05797467","url":"https://clinicaltrials.gov/study/NCT05797467"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05797467","phase":"3","setting":"Adjuvant Chemotherapy Combined With Targeted Therapy Versus Adjuvant Chemotherapy Alone in the Treatment of Stage T3-4N2 Colorectal Cancer:A Multicenter, Randomized, Phase III Clinical Trail","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2023-04-01","startedType":"actual","enrolled":366,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07296666","kind":"trial","name":"Adjuvant Chemotherapy for BTC Based on 3D-PTA","aka":[],"tldr":"A phase 2 trial of capecitabine in gallbladder cancer and other biliary tract cancers, run by Fudan University, not yet recruiting.","summary":"Adjuvant Chemotherapy for BTC Based on 3D-PTA is a phase 2, randomised interventional study registered as NCT07296666 by Fudan University, with a registry enrolment figure of 98 participants, started 2025-12 and due to reach its primary completion in 2027-10. Interventions recorded: Chemotherapy (preferably with a single chemotherapeutic agent) combined with capecitabine (including capecitabine monotherapy: when the preferred drug identified is capecitabine alone)., capecitabine alone as adjuvant treatment. Conditions listed: Cholangiocarcinoma. Gallbladder cancer is named in the registry entry: \"3. Histologically confirmed stage II/III biliary tract malignancies (including intrahepatic cholangiocarcinoma, extrahepatic/hilar cholangiocarcinoma, gallbladder cancer, distal bile duct cancer, or ampullary cancer);\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07296666","url":"https://clinicaltrials.gov/study/NCT07296666"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07296666","phase":"2","setting":"Adjuvant Therapy for Stage II/III Cholangiocarcinoma Based on 3D-PTA Susceptibility Testing: A Prospective, Multicenter, Randomized Controlled Trial","sponsor":"Fudan University","started":"2025-12","startedType":"estimated","enrolled":98,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04437160","kind":"trial","name":"Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy","aka":[],"tldr":"A phase 2 trial of epirubicin, pirarubicin and cyclophosphamide in triple-negative breast cancer, run by Chinese Academy of Medical Sciences, now recruiting.","summary":"Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy is a phase 2, randomised interventional study registered as NCT04437160 by Chinese Academy of Medical Sciences, with a registry enrolment figure of 286 participants, started 2020-02-01 and due to reach its primary completion in 2026-01. Interventions recorded: Epirubicin or Pirarubicin; Cyclophosphamide. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Triple negative breast cancer: hormone receptor negative (ER \\< 10% and PgR \\< 10%) and HER2 negative (IHC 0/1+ or ISH non-amplified), as defined by the local pathology laboratory\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04437160","url":"https://clinicaltrials.gov/study/NCT04437160"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["epirubicin","pirarubicin","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04437160","phase":"2","setting":"A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Efficacy and Safety of Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Platinum-based Neoadjuvant Chemotherapy","sponsor":"Chinese Academy of Medical Sciences","started":"2020-02-01","startedType":"actual","enrolled":286,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07802834","kind":"trial","name":"Adjuvant ctDNA-Adapted Treatment With Zipalertinib in Early-Stage Atypical EGFR-Mutant NSCLC","aka":[],"tldr":"A phase 2 trial of zipalertinib in lung cancer, run by Stanford University, not yet recruiting.","summary":"Adjuvant ctDNA-Adapted Treatment With Zipalertinib in Early-Stage Atypical EGFR-Mutant NSCLC is a phase 2, interventional study registered as NCT07802834 by Stanford University, with a registry enrolment figure of 42 participants, started 2026-11 and due to reach its primary completion in 2028-12. Interventions recorded: Zipalertinib. Conditions listed: EGFR; Lung Cancer (NSCLC); Non Small Cell Lung Cancer. Primary outcome: Molecular response rate at 12 weeks. Lung eligibility wording from the registry: \"Histological documentation of NSCLC (squamous histology is permitted)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07802834","url":"https://clinicaltrials.gov/study/NCT07802834"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":["zipalertinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07802834","phase":"2","setting":"Adjuvant ctDNA-Adapted Personalized Treatment With Zipalertinib in Early-Stage Atypical EGFR-Mutant NSCLC","sponsor":"Stanford University","started":"2026-11","startedType":"estimated","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05270044","kind":"trial","name":"Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.","aka":["COLUMBUS-AD"],"tldr":"A phase 3 trial of Encorafenib, Binimetinib in melanoma, run by Pierre Fabre Medicament, active and no longer recruiting.","summary":"Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. is a phase 3 interventional study registered as NCT05270044 by Pierre Fabre Medicament, with 815 participants planned, started 2022-05-02 and due to reach its primary completion in 2027-03-31. Interventions recorded: Encorafenib and Binimetinib, Placebo to match Encorafenib ; Placebo to match Binimetinib. Conditions listed: Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05270044","url":"https://clinicaltrials.gov/study/NCT05270044"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","stage-ii-melanoma","braf-v600-melanoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["encorafenib","binimetinib"],"companies":["pierre-fabre"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05270044","phase":"3","setting":"Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group","sponsor":"Pierre Fabre Medicament","started":"2022-05-02","startedType":"actual","enrolled":815,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06501482","kind":"trial","name":"Adjuvant FOLFIRI Based-chemotherapy After Resection of CLM Responding to Preoperative FOLFIRI","aka":["IRIMAD"],"tldr":"A phase 3 trial in colorectal cancer, run by Assistance Publique - Hôpitaux de Paris, now recruiting.","summary":"Adjuvant FOLFIRI Based-chemotherapy After Resection of CLM Responding to Preoperative FOLFIRI is a phase 3, randomised interventional study registered as NCT06501482 by Assistance Publique - Hôpitaux de Paris, with a registry enrolment figure of 254 participants, started 2025-06-27 and due to reach its primary completion in 2028-06-27. Interventions recorded: Postoperative reintroduction of FOLFIRI based chemotherapy. Conditions listed: Colorectal Cancer; Colorectal Liver Metastases. Primary outcome: The disease-free survival rate. Colorectal eligibility wording from the registry: \"For this study, metachronous CLM is defined as liver recurrence occurring more than 12 months after treatment of the primary colorectal cancer\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06501482","url":"https://clinicaltrials.gov/study/NCT06501482"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06501482","phase":"3","setting":"\"Interest of Postoperative Reintroduction of Chemotherapy in Patients Undergoing Resection of Colorectal Liver Metastases After Good Response to FOLFIRI-based Chemotherapy With or Without Targeted Agent\" (Intergroup FRENCH- PRODIGE)","sponsor":"Assistance Publique - Hôpitaux de Paris","started":"2025-06-27","startedType":"actual","enrolled":254,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07407517","kind":"trial","name":"Adjuvant Intensification for LAR","aka":["POLARIS"],"tldr":"A phase 3 trial in triple-negative breast cancer, run by Fudan University, not yet recruiting.","summary":"Adjuvant Intensification for LAR is a phase 3, randomised interventional study registered as NCT07407517 by Fudan University, with a registry enrolment figure of 904 participants, started 2026-02-01 and due to reach its primary completion in 2033-02-01. Interventions recorded: Everolimus 10 mg daily. Conditions listed: Breast Cancer Females; Triple Negative Breast Cancer (TNBC). Triple-negative eligibility wording from the registry: \"Histologically confirmed invasive triple-negative breast cancer (\\*\\*definition\\*\\*: breast cancer with estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) all confirmed negative by pathology\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07407517","url":"https://clinicaltrials.gov/study/NCT07407517"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07407517","phase":"3","setting":"Standard Chemotherapy Plus Oral Everolimus as Adjuvant Therapy for LAR Breast Cancer Patients: A Randomized, Open-Label, Phase III Trial （POLARIS）","sponsor":"Fudan University","started":"2026-02-01","startedType":"estimated","enrolled":904,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05179889","kind":"trial","name":"Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer","aka":[],"tldr":"A phase 2/3 trial of fOLFIRINOX / mFOLFIRINOX and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Chungnam National University Hospital, now recruiting.","summary":"Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer is a phase 2/3, randomised interventional study registered as NCT05179889 by Chungnam National University Hospital, with a registry enrolment figure of 308 participants, started 2021-07-06 and due to reach its primary completion in 2028-07-05. Interventions recorded: mFOLFIRINOX; mFOLFOX 6. Conditions listed: Colon Cancer Stage III. Primary outcome: Disease free survival (DFS). Colorectal eligibility wording from the registry: \"Pathologically confirmed high-risk stage III colon adenocarcinoma (pT4N1 or pTanyN2)\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05179889","url":"https://clinicaltrials.gov/study/NCT05179889"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfirinox","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05179889","phase":"2/3","setting":"mFOLFIRINOX Versus mFOLFOX 6 as Adjuvant Treatment for High Risk Stage III (pT4N1/2 or pTanyN2) Colon Cancer: Multicenter, Open Labeled, Randomized, Phase II Study","sponsor":"Chungnam National University Hospital","started":"2021-07-06","startedType":"actual","enrolled":308,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05427669","kind":"trial","name":"Adjuvant mFOLFOXIRI vs. mFOLFOX6 in MRD Positive Stage II-III Colorectal Cancer (AFFORD)","aka":["AFFORD"],"tldr":"A phase 3 trial of FOLFOXIRI and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Yanhong Deng, not yet recruiting.","summary":"Adjuvant mFOLFOXIRI vs. mFOLFOX6 in MRD Positive Stage II-III Colorectal Cancer (AFFORD) is a phase 3, randomised interventional study registered as NCT05427669 by Yanhong Deng, with a registry enrolment figure of 340 participants, started 2022-10-09 and due to reach its primary completion in 2025-07-01. Interventions recorded: mFOLFOXIRI; mFOLFOX6. Conditions listed: Colorectal Cancer. Primary outcome: 3-year Disease-free Survival (DFS). Colorectal eligibility wording from the registry: \"Histological or cytological documentation of adenocarcinoma of the colon or rectum\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05427669","url":"https://clinicaltrials.gov/study/NCT05427669"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfoxiri","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05427669","phase":"3","setting":"Adjuvant Modified FOLFOXIRI Versus mFOLFOX6 in Patients With Postoperative MRD Positive Stage II-III Colorectal Cancer: A Multicenter, Open Lable Randomized Phase 3 Study (AFFORD)","sponsor":"Yanhong Deng","started":"2022-10-09","startedType":"estimated","enrolled":340,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06520683","kind":"trial","name":"Adjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer","aka":["SMALLER"],"tldr":"A phase 3 trial of tislelizumab in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Adjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer is a phase 3, randomised interventional study registered as NCT06520683 by Sun Yat-sen University, with a registry enrolment figure of 180 participants, started 2024-11-01 and due to reach its primary completion in 2027-11-01. Interventions recorded: Tislelizumab; Adjuvant chemotherapy. Conditions listed: Colorectal Cancer; Microsatellite Instability High. Primary outcome: Disease-free survival (DFS). Colorectal eligibility wording from the registry: \"* dMMR and/or MSI-H colorectal carcinoma that undergo surgical resection\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06520683","url":"https://clinicaltrials.gov/study/NCT06520683"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06520683","phase":"3","setting":"Short-course PD-1 Blockade As Adjuvant Treatment for High-risk Stage-II DMMR/MSI-H Colorectal Cancer","sponsor":"Sun Yat-sen University","started":"2024-11-01","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04317534","kind":"trial","name":"Adjuvant Pembrolizumab vs Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm","aka":[],"tldr":"A phase 2 trial of pembrolizumab in lung cancer, run by Greg Durm, MD, now recruiting.","summary":"Adjuvant Pembrolizumab vs Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm is a phase 2, randomised interventional study registered as NCT04317534 by Greg Durm, MD, with a registry enrolment figure of 244 participants, started 2020-05-05 and due to reach its primary completion in 2027-04-08. Interventions recorded: Pembrolizumab. Conditions listed: NSCLC, Stage I. Primary outcome: Disease Free Survival (DFS). Lung eligibility wording from the registry: \"* Patients must have undergone complete surgical resection of their stage I NSCLC between 4-12 weeks prior to registration and have negative surgical margins (R0)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04317534","url":"https://clinicaltrials.gov/study/NCT04317534"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04317534","phase":"2","setting":"A Randomized Phase II Trial of Adjuvant Pembrolizumab Versus Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm: Big Ten Cancer Research Consortium BTCRC-LUN18-153","sponsor":"Greg Durm, MD","started":"2020-05-05","startedType":"actual","enrolled":244,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03280511","kind":"trial","name":"Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients","aka":["PIPAC-OPC3"],"tldr":"A phase 2 trial in colorectal cancer, run by Michael Bau Mortensen, now recruiting.","summary":"Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients is a phase 2, interventional study registered as NCT03280511 by Michael Bau Mortensen, with a registry enrolment figure of 60 participants, started 2017-12-14 and due to reach its primary completion in 2024-10-01. Interventions recorded: PIPAC. Conditions listed: Peritoneum Cancer; Peritoneal Carcinomatosis; Peritoneal Metastases; Colo-rectal Cancer. Primary outcome: The number of patients with peritoneal recurrence. Colorectal eligibility wording from the registry: \"* Radically resected colon cancer patients with adeno- or signet ring cell carcinomas with high-risk tumors defined as: perforated / pT4NanyM0 (UICC 8th edition) / pTanyNanyM1 with radically resected PM including ovarian metastases\". Sites: Denmark. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03280511","url":"https://clinicaltrials.gov/study/NCT03280511"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["hipec"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03280511","phase":"2","setting":"Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients - The PIPAC-OPC3 CC Trial","sponsor":"Michael Bau Mortensen","started":"2017-12-14","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04724980","kind":"trial","name":"Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis","aka":[],"tldr":"A phase 1/2 trial of PRGN-2012 - Phase I; Dose Level 1 in rare cancers of childhood, run by Precigen, Inc, active and no longer recruiting.","summary":"Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis is a phase 1/2 interventional study registered as NCT04724980 by Precigen, Inc, with 38 participants enrolled, started 2021-03-16 and due to reach its primary completion in 2024-06-05. Interventions recorded: PRGN-2012 - Phase I; Dose Level 1, PRGN-2012 - Phase I; Dose Level 2 and PRGN-2012 - Phase II; Dose Level 2.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04724980","url":"https://clinicaltrials.gov/study/NCT04724980"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rare-childhood-cancers"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["precigen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04724980","phase":"1/2","setting":"A Phase 1/2 Study of Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis","sponsor":"Precigen, Inc","started":"2021-03-16","startedType":"actual","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06323148","kind":"trial","name":"Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022)","aka":[],"tldr":"A phase 3 trial of osimertinib in lung cancer, run by Fudan University, not yet recruiting.","summary":"Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022) is a phase 3, randomised interventional study registered as NCT06323148 by Fudan University, with a registry enrolment figure of 226 participants, started 2024-04-01 and due to reach its primary completion in 2026-03-31. Interventions recorded: Osimertinib; No adjuvant therapy. Conditions listed: Lung Cancer; EGFR Gene Mutation; Minimal Residual Disease. Primary outcome: The 3-year Disease-Free Survival (DFS) rate between the observation group and the osimertinib treatment group.. Lung eligibility wording from the registry: \"Histologically confirmed diagnosis of non-small cell lung cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06323148","url":"https://clinicaltrials.gov/study/NCT06323148"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors","mrd-testing"],"targets":[],"drugs":["osimertinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06323148","phase":"3","setting":"Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA","sponsor":"Fudan University","started":"2024-04-01","startedType":"estimated","enrolled":226,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07225621","kind":"trial","name":"Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma","aka":[],"tldr":"A phase 2 trial of Aminolevulinic acid (topical, for photodynamic therapy) in glioma & glioblastoma, run by Alpheus Medical, Inc., now recruiting.","summary":"Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma is a phase 2 interventional study registered as NCT07225621 by Alpheus Medical, Inc., with 103 participants planned, started 2026-01-28 and due to reach its primary completion in 2027-12. Interventions recorded: 5-ALA HCl + LIDU SDT and Placebo + Sham SDT.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07225621","url":"https://clinicaltrials.gov/study/NCT07225621"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["precancer-ablation"],"targets":[],"drugs":["aminolevulinic-acid"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07225621","phase":"2","setting":"Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Standard of Care Adjuvant Temozolomide With or Without 5-Aminolevulinic Acid (5-ALA) With Concomitant Low Intensity Diffuse Ultrasound (LIDU) Sonodynamic Therapy (SDT) System In Patients With Newly Diagnosed Glioblastoma After Completion of Chemoradiotherapy","sponsor":"Alpheus Medical, Inc.","started":"2026-01-28","startedType":"actual","enrolled":103,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02132390","kind":"trial","name":"Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea","aka":[],"tldr":"A phase 3 trial of Goserelin / leuprolide and Toremifene in Breast cancer, run by Peking Union Medical College Hospital, with a status the registry has not verified recently.","summary":"Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea is a phase 3 interventional study registered as NCT02132390 by Peking Union Medical College Hospital, with 300 participants planned, started 2014-05 and due to reach its primary completion in 2024-05. Interventions recorded: Goserelin, Toremifene. Conditions recorded: Breast Cancer, Chemotherapy Induced Amenorrhea, Ovarian Function Suppression.\n\nLinked to the drug Toremifene because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02132390","url":"https://clinicaltrials.gov/study/NCT02132390"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["goserelin","toremifene"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02132390","phase":"3","setting":"Study of Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea","sponsor":"Peking Union Medical College Hospital","started":"2014-05","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04772287","kind":"trial","name":"Adjuvant Toripalimab Plus Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) NSCLC (LungMate-008)","aka":["LungMate-008"],"tldr":"A phase 3 trial of toripalimab in lung cancer, run by Shanghai Pulmonary Hospital, Shanghai, China, not yet recruiting.","summary":"Adjuvant Toripalimab Plus Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) NSCLC (LungMate-008) is a phase 3, randomised interventional study registered as NCT04772287 by Shanghai Pulmonary Hospital, Shanghai, China, with a registry enrolment figure of 341 participants, started 2021-03-31 and due to reach its primary completion in 2026-12-30. Interventions recorded: Toripalimab; Toripalimab mimetic (placebo). Conditions listed: Non Small Cell Lung Cancer. Primary outcome: Disease-free survival (DFS). Lung eligibility wording from the registry: \"Histological diagnosis of primary non-small cell lung cancer (NSCLC)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04772287","url":"https://clinicaltrials.gov/study/NCT04772287"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","alk-positive-nsclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04772287","phase":"3","setting":"Adjuvant Toripalimab Versus Placebo Combined With Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) Non-small-cell Lung Cancer (LungMate-008): a Randomised, Double-blind, Controlled, Phase 3 Trial","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","started":"2021-03-31","startedType":"estimated","enrolled":341,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06780839","kind":"trial","name":"Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD","aka":[],"tldr":"A phase 2 trial of ensartinib in lung cancer, run by Peking University Cancer Hospital & Institute, not yet recruiting.","summary":"Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD is a phase 2, interventional study registered as NCT06780839 by Peking University Cancer Hospital & Institute, with a registry enrolment figure of 70 participants, started 2025-01-15 and due to reach its primary completion in 2029-01-15. Interventions recorded: Ensartinib. Conditions listed: NSCLC, Stage I, II, IIIA, IIIB. Primary outcome: DFS. Lung eligibility wording from the registry: \"Histologically confirmed primary non-small cell lung cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06780839","url":"https://clinicaltrials.gov/study/NCT06780839"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["alk-positive-nsclc","resectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ensartinib"],"companies":["betta"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06780839","phase":"2","setting":"Postoperative Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD: a Single-arm, Multicenter Study","sponsor":"Peking University Cancer Hospital & Institute","started":"2025-01-15","startedType":"estimated","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02455141","kind":"trial","name":"Adjuvant Treatment of EC Followed by Taxane +/- Carboplatin in Triple-Negative Breast Cancer","aka":["TCTN"],"tldr":"A phase 3 trial of epirubicin, cyclophosphamide and carboplatin in triple-negative breast cancer, run by Shanghai Jiao Tong University School of Medicine, active but no longer recruiting.","summary":"Adjuvant Treatment of EC Followed by Taxane +/- Carboplatin in Triple-Negative Breast Cancer is a phase 3, randomised interventional study registered as NCT02455141 by Shanghai Jiao Tong University School of Medicine, with a registry enrolment figure of 786 participants, started 2016-03 and due to reach its primary completion in 2027-03. Interventions recorded: Epirubicin plus Cyclophosphamide; Taxanes; Taxanes plus Carboplatin. Conditions listed: Breast Neoplasm. Triple-negative eligibility wording from the registry: \"* Tumor specimens are available for estrogen receptor (ER), progesterone receptor (PgR) and Her2 (human epidermal-growth-factor receptor 2) detection, patients should be with triple negative breast cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02455141","url":"https://clinicaltrials.gov/study/NCT02455141"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["epirubicin","cyclophosphamide","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02455141","phase":"3","setting":"Epirubicin-Cyclophosphamide Followed by Taxanes or Taxanes Plus Carboplatin in Triple-Negative Breast Cancer：A Prospective, Randomized, Phase III Trial","sponsor":"Shanghai Jiao Tong University School of Medicine","started":"2016-03","startedType":"actual","enrolled":786,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00576914","kind":"trial","name":"Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of Recombinant human endostatin in Non-small-cell lung cancer, run by Chinese Academy of Sciences, with a status the registry has not verified recently.","summary":"Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT00576914 by Chinese Academy of Sciences, with 1108 participants planned, started 2007-06 and due to reach its primary completion in 2012-06. Interventions recorded: recombinant human endostatin. Conditions recorded: Non-small Cell Lung Cancer.\n\nLinked to the drug Recombinant human endostatin because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00576914","url":"https://clinicaltrials.gov/study/NCT00576914"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["recombinant-human-endostatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00576914","phase":"3","setting":"Adjuvant Vinorelbine Plus Cisplatin Versus Vinorelbine Plus Cisplatin Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer (Phase III Study, Randomized, Open, Multi-center)","sponsor":"Chinese Academy of Sciences","started":"2007-06","enrolled":1108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01124253","kind":"trial","name":"Adjuvant Vinorelbine Plus Cisplatin(NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer(NSCLC)","aka":["Dengshan"],"tldr":"A phase 3 trial of Recombinant human endostatin in Non-small-cell lung cancer, run by Shanghai Jiao Tong University School of Medicine, completed.","summary":"Adjuvant Vinorelbine Plus Cisplatin(NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer(NSCLC) is a phase 3 interventional study registered as NCT01124253 by Shanghai Jiao Tong University School of Medicine, with 250 participants recorded, started 2007-07 and reaching its primary completion in 2009-10. Interventions recorded: recombinant human endostatin. Conditions recorded: Non-small Cell Lung Cancer.\n\nLinked to the drug Recombinant human endostatin because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01124253","url":"https://clinicaltrials.gov/study/NCT01124253"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["recombinant-human-endostatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01124253","phase":"3","setting":"Phase III Study of Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer","sponsor":"Shanghai Jiao Tong University School of Medicine","started":"2007-07","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"admec-o","kind":"trial","name":"ADMEC-O (adjuvant nivolumab in completely resected Merkel cell carcinoma)","aka":["ADMEC-O","ADMEC"],"tldr":"Merkel cell carcinoma comes back in a quarter of people even after the surgeon has removed it all. Giving immunotherapy afterwards for a year reduced that by about ten in every hundred, but the trial was small and cannot yet say whether anyone lived longer.","summary":"Merkel cell carcinoma relapses often after complete resection and radiotherapy, and until this trial there was no systemic standard for the situation. Twenty academic centres in Germany and the Netherlands randomised 179 patients 2 to 1 to nivolumab 480 mg every four weeks for a year or to observation. Sixty-five per cent had stage 3 or 4 disease, 68 per cent were 65 or older, and adjuvant radiotherapy was more common in the control group, which is an imbalance worth holding in mind.\n\nAt a median follow-up of 24.3 months, median disease-free survival had not been reached in either arm. Disease-free survival was 85 per cent at 12 months and 84 per cent at 24 months with nivolumab, against 77 and 73 per cent with observation, a hazard ratio of 0.58 (95 per cent confidence interval 0.30 to 1.12) whose interval crosses one. The authors state the effect as an absolute risk reduction of 9 percentage points at one year and 10 at two.\n\nSafety is the other half of the trade: grade 3 or 4 adverse events in 48 of 115 treated patients (42 per cent) against 7 of 61 (11 per cent) under observation, with no treatment-related deaths.\n\nThe trial's own interpretation is unusually candid and should be quoted rather than smoothed: overall survival had ten events in the treatment group and six in the observation group, which is half the size, and is not mature enough to draw conclusions from. An accompanying comment in the same issue of the journal asked directly whether adjuvant nivolumab should be used on this evidence. It is a phase 2 result in a rare disease, which is often all a rare disease gets, and the honest description is a promising signal rather than a proven standard.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02196961","url":"https://clinicaltrials.gov/study/NCT02196961"},{"label":"Interim analysis (The Lancet 2023)","url":"https://doi.org/10.1016/S0140-6736(23)00769-9"},{"label":"Interim analysis on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/37451295/"},{"label":"Accompanying comment (The Lancet 2023)","url":"https://doi.org/10.1016/S0140-6736(23)01041-3"}],"tags":[],"related":[],"cancers":["merkel-cell-carcinoma","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["nivolumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["irae","mcpyv-status"],"trials":["stamp-merkel","javelin-merkel-200","keynote-017","pod1um-201"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02196961","phase":"2","setting":"Completely resected Merkel cell carcinoma of any stage: nivolumab 480 mg every four weeks for one year against observation, randomised 2 to 1 and stratified by stage, age and sex, with landmark disease-free survival at 12 and 24 months as the primary endpoint","sponsor":"University Hospital Essen, funded by Bristol Myers Squibb","result":"Disease-free survival 85 per cent at 12 months and 84 per cent at 24 months with adjuvant nivolumab against 77 and 73 per cent with observation (hazard ratio 0.58, 95 per cent confidence interval 0.30 to 1.12); grade 3 or 4 adverse events 42 against 11 per cent.","started":"2014-06","startedType":"actual","yearReported":2023,"enrolled":179,"enrolledBasis":"randomised","enrolledNote":"179 patients were randomised 2 to 1 between October 2014 and August 2020, 118 to nivolumab and 61 to observation; the ClinicalTrials.gov record NCT02196961 gives an enrolment of 180.","outcomes":[{"endpoint":"Disease-free survival at 24 months","primary":true,"unit":"%","arms":[{"name":"Adjuvant nivolumab for 1 year","n":118,"value":84},{"name":"Observation","n":61,"value":73}],"hr":0.58,"ci":[0.3,1.12],"source":"https://doi.org/10.1016/s0140-6736(23)00769-9"},{"endpoint":"Disease-free survival at 12 months","primary":true,"unit":"%","arms":[{"name":"Adjuvant nivolumab for 1 year","n":118,"value":85},{"name":"Observation","n":61,"value":77}],"source":"https://doi.org/10.1016/s0140-6736(23)00769-9"},{"endpoint":"Grade 3 or 4 adverse events","unit":"%","arms":[{"name":"Adjuvant nivolumab for 1 year","n":115,"value":42,"note":"48 of the 115 who received at least one dose"},{"name":"Observation","n":61,"value":11,"note":"7 of 61"}],"source":"https://doi.org/10.1016/s0140-6736(23)00769-9"}],"replication":"STAMP, the ECOG-ACRIN phase 3 of adjuvant pembrolizumab against observation, is the randomised phase 3 test of the same question and has not reported."},{"id":"nct02830724","kind":"trial","name":"Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers","aka":[],"tldr":"A phase 1/2 trial of cyclophosphamide, fludarabine and aldesleukin (high-dose IL-2) in pancreatic cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers is a phase 1/2, interventional study registered as NCT02830724 by National Cancer Institute (NCI), with a registry enrolment figure of 124 participants, started 2017-04-06 and due to reach its primary completion in 2029-01-01. Interventions recorded: Cyclophosphamide; Fludarabine; Aldesleukin; Anti-hCD70 CAR transduced PBL. Conditions listed: Pancreatic Cancer; Renal Cell Cancer; Breast Cancer; Melanoma; Ovarian Cancer. Primary outcome: Frequency and severity of treatment-related adverse events; Response rate. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02830724","url":"https://clinicaltrials.gov/study/NCT02830724"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["car-t","cytotoxic-chemotherapy"],"targets":[],"drugs":["cyclophosphamide","fludarabine","aldesleukin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02830724","phase":"1/2","setting":"A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70-Expressing Cancers","sponsor":"National Cancer Institute (NCI)","started":"2017-04-06","startedType":"actual","enrolled":124,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03190941","kind":"trial","name":"Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients","aka":[],"tldr":"A phase 1/2 trial of cyclophosphamide, fludarabine and aldesleukin (high-dose IL-2) in pancreatic cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients is a phase 1/2, interventional study registered as NCT03190941 by National Cancer Institute (NCI), with a registry enrolment figure of 110 participants, started 2017-09-21 and due to reach its primary completion in 2027-06-29. Interventions recorded: Cyclophosphamide; Fludarabine; Anti-KRAS G12V mTCR PBL; Aldesleukin. Conditions listed: Pancreatic Cancer; Gastric Cancer; Gastrointestinal Cancer; Colon Cancer; Rectal Cancer. Primary outcome: Response rate; Frequency and severity of treatment-related adverse events. Pancreatic eligibility wording from the registry: \"* Patients with pancreatic cancer must have received gemcitabine, 5FU, and oxaliplatin (or similar agents), or have contraindications to receiving those medications\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03190941","url":"https://clinicaltrials.gov/study/NCT03190941"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cyclophosphamide","fludarabine","aldesleukin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03190941","phase":"1/2","setting":"A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients","sponsor":"National Cancer Institute (NCI)","started":"2017-09-21","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"admiral","kind":"trial","name":"ADMIRAL","aka":[],"tldr":"Showed a pill beats intensive salvage chemotherapy in relapsed FLT3-mutated AML, with fewer days in hospital.","summary":"ADMIRAL, trial NCT02421939 sponsored by Astellas and published in the New England Journal of Medicine in 2019, showed that the FLT3 inhibitor gilteritinib as a single tablet beats intensive salvage chemotherapy in relapsed or refractory FLT3-mutated acute myeloid leukaemia, with fewer days in hospital. It randomised 371 patients, met its primary endpoints of overall survival and complete remission with partial haematological recovery, converted gilteritinib's accelerated approval to full approval and made FLT3 inhibitor monotherapy the standard bridge to transplant at relapse. OnCo links it to acute myeloid leukaemia, FLT3 as a target, gilteritinib, Alexander E. Perl and the ADMIRAL paper. Whether gilteritinib should be combined with venetoclax or chemotherapy at relapse is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02421939","url":"https://clinicaltrials.gov/study/NCT02421939"},{"label":"NEJM 2019","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1902688"}],"tags":[],"related":[],"cancers":["aml","aml-flt3"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["flt3"],"drugs":["gilteritinib"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["alexander-perl"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02421939","phase":"3","setting":"Relapsed or refractory FLT3-mutated AML: gilteritinib monotherapy vs salvage chemotherapy","sponsor":"Astellas","result":"OS 9.3 vs 5.6 months; HR 0.64.","started":"2015-10-20","startedType":"actual","yearReported":2019,"enrolled":371,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Gilteritinib","n":247,"value":9.3},{"name":"Salvage chemotherapy","n":124,"value":5.6}],"hr":0.64,"ci":[0.49,0.83],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1902688"},{"endpoint":"CR/CRh","primary":true,"unit":"%","arms":[{"name":"Gilteritinib","value":34},{"name":"Salvage chemotherapy","value":15.3}],"source":"https://doi.org/10.1056/NEJMoa1902688"}],"replication":"Real-world cohorts reproduce ~30% CR/CRh; the LACEWING trial (gilteritinib + azacitidine in unfit frontline) did not improve OS, showing the setting matters."},{"id":"nct03801083","kind":"trial","name":"Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers","aka":[],"tldr":"A phase 2 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by Udai Kammula, active and no longer recruiting.","summary":"Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers is a phase 2 interventional study registered as NCT03801083 by Udai Kammula, with a registry enrolment figure of 4 participants, started 2019-02-19 and due to reach its primary completion in 2030-01-31. Interventions recorded: Tumor Infiltrating Lymphocytes (TIL). Conditions listed: Biliary Tract Cancer, Cholangiocarcinoma, Biliary Tract Neoplasms. Gallbladder cancer is named in the registry entry: \"* Measurable locally advanced, recurrent, or metastatic biliary tract carcinoma (including intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma).\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03801083","url":"https://clinicaltrials.gov/study/NCT03801083"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03801083","phase":"2","setting":"A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients With Locally Advanced, Recurrent, or Metastatic Biliary Tract Cancers","sponsor":"Udai Kammula","started":"2019-02-19","startedType":"actual","enrolled":4,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05601752","kind":"trial","name":"ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3)","aka":["SURPASS-3"],"tldr":"A phase 2 trial of Nivolumab in ovarian cancer, run by USWM CT, LLC, active and no longer recruiting.","summary":"ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3) is a phase 2 interventional study registered as NCT05601752 by USWM CT, LLC, with 66 participants planned, started 2023-06-26 and due to reach its primary completion in 2026-08-12. Interventions recorded: Autologous genetically modified ADP-A2M4CD8 cells, Autologous genetically modified ADP-A2M4CD8 cells in combination with Nivolumab. Conditions listed: Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05601752","url":"https://clinicaltrials.gov/study/NCT05601752"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05601752","phase":"2","setting":"A Phase 2, Open-Label, Randomized, Non-Comparative Clinical Trial of ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in Subjects With Recurrent Ovarian Cancers","sponsor":"USWM CT, LLC","started":"2023-06-26","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"adriatic","kind":"trial","name":"ADRIATIC","aka":[],"tldr":"ADRIATIC brought the first improvement in curative-intent small-cell lung cancer treatment in 30 years: a year or two of immunotherapy after chemoradiation lengthens life.","summary":"ADRIATIC, trial NCT03703297 sponsored by AstraZeneca and reported in 2024, brought the first improvement in curative-intent small-cell lung cancer treatment in thirty years: durvalumab consolidation for up to two years after concurrent chemoradiotherapy for limited-stage disease lengthens life. It randomised 730 patients without progression after chemoradiation to durvalumab or placebo and met both primary endpoints of overall and progression-free survival, leading to FDA approval on 4 December 2024, with benefit regardless of prophylactic cranial irradiation. OnCo links it to small-cell lung cancer, modern radiotherapy, prophylactic cranial irradiation, durvalumab, the limited-stage and PCI terms and Corinne Faivre-Finn, and it applies the PACIFIC template to small-cell disease. It is a single pivotal trial, and whether real-world consolidation series reproduce it is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03703297","url":"https://clinicaltrials.gov/study/NCT03703297"},{"label":"FDA approval (Dec 2024)","url":"https://www.onclive.com/view/fda-approves-durvalumab-for-limited-stage-small-cell-lung-cancer"}],"tags":[],"related":[],"cancers":["sclc","limited-stage-sclc"],"sections":[],"technologies":["imrt-igrt","prophylactic-cranial-irradiation"],"targets":[],"drugs":["durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["limited-extensive-stage","pci-term"],"trials":[],"people":["corinne-faivre-finn"],"bottlenecks":[],"keyPapers":["paper-adriatic-nejm-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03703297","phase":"3","setting":"Limited-stage SCLC without progression after concurrent chemoradiotherapy: durvalumab consolidation (up to 2 years) vs placebo","sponsor":"AstraZeneca","result":"OS 55.9 vs 33.4 months, HR 0.73.","started":"2018-09-27","startedType":"actual","yearReported":2024,"enrolled":730,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Durvalumab","n":264,"value":55.9},{"name":"Placebo","n":266,"value":33.4}],"hr":0.73,"ci":[0.57,0.93],"p":"0.0104","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2404873"},{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Durvalumab","value":16.6},{"name":"Placebo","value":9.2}],"hr":0.76,"ci":[0.61,0.95],"source":"https://doi.org/10.1056/NEJMoa2404873"}],"replication":"Single pivotal trial; consistent with PACIFIC in NSCLC. Real-world consolidation series are emerging."},{"id":"nct00022282","kind":"trial","name":"AE-941 in Treating Patients With Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 2 trial of Shark cartilage in Multiple myeloma, run by AEterna Zentaris, completed.","summary":"AE-941 in Treating Patients With Relapsed or Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT00022282 by AEterna Zentaris, started 2001-04 and reaching its primary completion in 2007-03. Interventions recorded: shark cartilage extract AE-941. Conditions recorded: Multiple Myeloma and Plasma Cell Neoplasm.\n\nLinked to the technology Shark cartilage because the registry names it (\"shark cartilage\") among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00022282","url":"https://clinicaltrials.gov/study/NCT00022282"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["shark-cartilage"],"targets":[],"drugs":[],"companies":["aeterna-zentaris"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00022282","phase":"2","setting":"Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients","sponsor":"AEterna Zentaris","started":"2001-04","enrolledBasis":"registry","outcomes":[]},{"id":"aeneas","kind":"trial","name":"AENEAS","aka":[],"tldr":"The trial that showed Hansoh's aumolertinib roughly doubles progression-free survival compared with gefitinib in EGFR-mutant lung cancer.","summary":"429 patients, double blind. Median progression-free survival 19.3 versus 9.9 months (hazard ratio 0.46), consistent across exon 19 and L858R subgroups and in patients with brain metastases; published in the Journal of Clinical Oncology 2022. NMPA first-line approval December 2021. Aumolertinib has since become one of the most prescribed targeted drugs in China.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03849768","url":"https://clinicaltrials.gov/study/NCT03849768"},{"label":"J Clin Oncol 2022","url":"https://doi.org/10.1200/JCO.21.02641"}],"tags":["china"],"related":["furlong"],"cancers":["nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["egfr"],"drugs":["aumolertinib","gefitinib"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-aeneas-j-clin-oncol-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03849768","phase":"3","setting":"First-line EGFR-mutant (exon 19 deletion or L858R) locally advanced or metastatic NSCLC, China: aumolertinib vs gefitinib","sponsor":"Hansoh Pharmaceutical","result":"PFS 19.3 vs 9.9 months, HR 0.46.","started":"2019-02-01","startedType":"actual","yearReported":2022,"enrolled":429,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Aumolertinib","n":214,"value":19.3},{"name":"Gefitinib","n":215,"value":9.9}],"hr":0.46,"source":"https://doi.org/10.1200/JCO.21.02641"}]},{"id":"aethera","kind":"trial","name":"AETHERA","aka":[],"tldr":"In AETHERA, a year of the CD30 ADC after transplant halved relapse risk in high-risk patients.","summary":"AETHERA, trial NCT01100502 sponsored by Seagen and published in the Lancet in 2015, showed that a year of the CD30 antibody-drug conjugate brentuximab vedotin after autologous transplant halved the risk of relapse in high-risk Hodgkin lymphoma. It randomised 329 patients to brentuximab consolidation or placebo and met its primary progression-free survival endpoint with a large effect, while overall survival did not differ because of crossover, leading to approval in August 2015 as post-transplant consolidation. OnCo links it to Hodgkin lymphoma, autologous transplant and brentuximab vedotin. Now that brentuximab and PD-1 blockade are used before transplant, whether consolidation still adds anything is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01100502","url":"https://clinicaltrials.gov/study/NCT01100502"}],"tags":[],"related":[],"cancers":["hodgkin-lymphoma","relapsed-refractory-hodgkin-lymphoma"],"sections":[],"technologies":["autologous-stem-cell-transplant"],"targets":[],"drugs":["brentuximab-vedotin"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01100502","phase":"3","setting":"High-risk Hodgkin lymphoma after autologous transplant: brentuximab vedotin consolidation vs placebo","sponsor":"Seagen","result":"PFS HR 0.57.","started":"2010-04-30","startedType":"actual","yearReported":2015,"enrolled":329,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Brentuximab vedotin","n":165,"value":42.9},{"name":"Placebo","n":164,"value":24.1}],"hr":0.57,"ci":[0.4,0.81],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)60165-9/fulltext"}]},{"id":"aews0031","kind":"trial","name":"AEWS0031","aka":["COG AEWS0031"],"tldr":"AEWS0031 showed that giving the same chemotherapy for Ewing sarcoma every two weeks instead of every three cured more patients without adding side effects, and the two-weekly schedule became the standard for localised disease in North America.","summary":"AEWS0031 was a Children's Oncology Group phase 3 trial that randomised 587 patients (568 eligible, 284 per arm) with localised Ewing sarcoma to fourteen cycles of alternating vincristine, doxorubicin, cyclophosphamide and ifosfamide, etoposide given every 21 days or every 14 days with growth factor support. The primary endpoint was event-free survival.\n\nThe median cycle interval achieved was 21 days in the standard arm and 15 days in the intensified arm. Event-free survival at five years was 73 percent with interval compression against 65 percent with the standard schedule, with similar toxicity. Interval-compressed VDC/IE is the standard first-line regimen on the corpus's Ewing sarcoma page, alongside the European Euro Ewing 2012 result that reached the same conclusion.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00006734","url":"https://clinicaltrials.gov/study/NCT00006734"}],"tags":["soc-trials"],"related":[],"cancers":["ewing-sarcoma","sarcoma","childhood-cancers"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["vincristine","doxorubicin","cyclophosphamide","ifosfamide","etoposide","filgrastim"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-aews0031-interval-compressed-chemotherapy-ewing-womer-jco-2012"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00006734","phase":"3","setting":"Localised Ewing sarcoma in patients under 50: fourteen cycles of alternating vincristine, doxorubicin and cyclophosphamide with ifosfamide and etoposide given every three weeks (standard) or every two weeks with filgrastim support (interval-compressed), around local control with surgery or radiotherapy","sponsor":"Children's Oncology Group","result":"Five-year event-free survival 73 percent with two-weekly (interval-compressed) chemotherapy against 65 percent with three-weekly chemotherapy (p 0.048), with similar toxicity.","started":"2001-05","yearReported":2012,"enrolled":587,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Interval-compressed VDC/IE every 14 days","n":284,"value":73},{"name":"Standard VDC/IE every 21 days","n":284,"value":65}],"p":"0.048","source":"https://doi.org/10.1200/JCO.2011.41.5703"}]},{"id":"affinity-custirsen","kind":"trial","name":"AFFINITY","aka":["AFFINITY","custirsen with cabazitaxel"],"tldr":"The second attempt with the same drug, this time after chemotherapy had already failed once. It also found nothing, including in the men expected to benefit most.","summary":"AFFINITY randomised 635 men whose metastatic castration-resistant prostate cancer had progressed after docetaxel to cabazitaxel and prednisone with or without custirsen, stratified by opioid use for cancer-related pain, radiographic evidence of progression on first-line docetaxel, and previous abiraterone or enzalutamide.\n\nMedian follow-up was 28.3 months in the custirsen group and 29.8 months in the control group. Median overall survival was 14.1 months (95 percent confidence interval 12.7 to 15.9) with custirsen and 13.4 months (12.1 to 14.9) without, hazard ratio 0.95 (0.80 to 1.12, log-rank p=0.53). In the prespecified poor-prognosis subgroup, the co-primary endpoint, it was 11.0 months (9.3 to 13.3) against 10.9 months (8.2 to 12.4), hazard ratio 0.97 (0.80 to 1.21, p=0.80).\n\nThe commonest grade 3 or worse adverse events with custirsen against control were neutropenia (70 of 315 against 61 of 312), anaemia (68 against 49), fatigue (23 against 18), asthenia (16 against 8), bone pain (16 against 5) and febrile neutropenia (16 against 9). Serious adverse events occurred in 155 (49 percent) against 132 (42 percent). Twenty-seven men died within 30 days of treatment in the custirsen group against 17 in the control group.\n\nWith SYNERGY, this ended the clusterin hypothesis as a therapeutic target in prostate cancer.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01578655","url":"https://clinicaltrials.gov/study/NCT01578655"},{"label":"AFFINITY (Lancet Oncology 2017)","url":"https://doi.org/10.1016/S1470-2045(17)30605-8"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["antisense-sirna","cytotoxic-chemotherapy"],"targets":[],"drugs":["custirsen","cabazitaxel","prednisone"],"companies":["achieve-life-sciences"],"institutions":[],"pathways":[],"terms":["castration-resistance"],"trials":["synergy-custirsen","tropic"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01578655","phase":"3","setting":"Radiographically documented metastatic castration-resistant prostate cancer progressing after docetaxel, Karnofsky score above 70 percent: cabazitaxel 25 mg/m2 every 21 days with prednisone 10 mg daily, with or without custirsen 640 mg on days 1, 8 and 15 plus three loading doses, for up to ten cycles, with co-primary endpoints of overall survival in all randomised men and in a poor-prognosis subgroup","sponsor":"OncoGenex Technologies","result":"Median overall survival 14.1 against 13.4 months (hazard ratio 0.95, 95 percent confidence interval 0.80 to 1.12) overall, and 11.0 against 10.9 months (0.97, 0.80 to 1.21) in the poor-prognosis subgroup: no benefit on either co-primary endpoint.","started":"2012-08","yearReported":2017,"enrolled":635,"enrolledBasis":"randomised","enrolledNote":"795 men were screened between 9 September 2012 and 29 September 2014 and 635 were randomised at 95 cancer treatment centres in eight countries.","outcomes":[{"endpoint":"Overall survival, all randomised (median)","primary":true,"unit":"months","arms":[{"name":"Cabazitaxel, prednisone and custirsen","n":317,"value":14.1},{"name":"Cabazitaxel and prednisone","n":318,"value":13.4}],"hr":0.95,"ci":[0.8,1.12],"p":"0.53","source":"https://doi.org/10.1016/S1470-2045(17)30605-8"},{"endpoint":"Overall survival, poor-prognosis subgroup (median)","primary":true,"unit":"months","arms":[{"name":"Cabazitaxel, prednisone and custirsen","value":11},{"name":"Cabazitaxel and prednisone","value":10.9}],"hr":0.97,"ci":[0.8,1.21],"p":"0.80","source":"https://doi.org/10.1016/S1470-2045(17)30605-8"}],"replication":"SYNERGY had already failed with the same drug and first-line docetaxel in 1,022 men."},{"id":"affirm","kind":"trial","name":"AFFIRM","aka":["AFFIRM","MDV3100-03"],"tldr":"Showed that a drug blocking the androgen receptor itself, rather than the hormones that feed it, adds nearly five months of life after chemotherapy has failed.","summary":"AFFIRM randomised 1,199 men with castration-resistant prostate cancer after docetaxel 2:1 to enzalutamide 160 mg daily (800) or placebo (399), stratified by ECOG performance status and pain intensity. The trial was stopped at a planned interim analysis after 520 deaths.\n\nMedian overall survival was 18.4 months (95 percent confidence interval 17.3 to not yet reached) with enzalutamide against 13.6 months (11.3 to 15.8) with placebo, hazard ratio 0.63 (0.53 to 0.75, p<0.001). Every secondary endpoint favoured enzalutamide: PSA fall of 50 percent or more in 54 against 2 percent, soft-tissue response 29 against 4 percent, quality-of-life response 43 against 18 percent, time to PSA progression 8.3 against 3.0 months (hazard ratio 0.25), radiographic progression-free survival 8.3 against 2.9 months (0.40) and time to first skeletal-related event 16.7 against 13.3 months (0.69), all p<0.001.\n\nFatigue, diarrhoea and hot flushes were more common with enzalutamide. Seizures occurred in five men (0.6 percent), which is the toxicity that defines the drug's contraindications and the reason it is used cautiously in men with a seizure history or brain metastases.\n\nIn England NICE TA316 recommends enzalutamide within its marketing authorisation for metastatic hormone-relapsed prostate cancer that has progressed during or after docetaxel, with the patient access scheme discount, and explicitly states that use after abiraterone is not covered by that guidance.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00974311","url":"https://clinicaltrials.gov/study/NCT00974311"},{"label":"AFFIRM (New England Journal of Medicine 2012)","url":"https://doi.org/10.1056/NEJMoa1207506"},{"label":"NICE TA316: enzalutamide for metastatic hormone-relapsed prostate cancer previously treated with a docetaxel-containing regimen","url":"https://www.nice.org.uk/guidance/ta316"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":["androgen-receptor"],"drugs":["enzalutamide"],"companies":["astellas","pfizer"],"institutions":[],"pathways":[],"terms":["arpi","castration-resistance","psa50","qol-pro"],"trials":["prevail","cou-aa-301","card"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00974311","phase":"3","setting":"Metastatic castration-resistant prostate cancer after docetaxel, stratified by ECOG performance status and pain intensity: enzalutamide 160 mg daily against placebo, randomised 2:1, with overall survival as the primary endpoint","sponsor":"Medivation and Astellas Pharma Global Development","result":"Median overall survival 18.4 against 13.6 months (hazard ratio 0.63, 95 percent confidence interval 0.53 to 0.75) after docetaxel; PSA fall of 50 percent or more in 54 against 2 percent; seizures in 0.6 percent.","started":"2009-09-30","startedType":"actual","yearReported":2012,"enrolled":1199,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Enzalutamide 160 mg daily","n":800,"value":18.4},{"name":"Placebo","n":399,"value":13.6}],"hr":0.63,"ci":[0.53,0.75],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1207506"},{"endpoint":"Radiographic progression-free survival (median)","unit":"months","arms":[{"name":"Enzalutamide 160 mg daily","n":800,"value":8.3},{"name":"Placebo","n":399,"value":2.9}],"hr":0.4,"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1207506"},{"endpoint":"PSA decline of 50 percent or more","unit":"%","arms":[{"name":"Enzalutamide 160 mg daily","n":800,"value":54},{"name":"Placebo","n":399,"value":2}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1207506"}],"replication":"COU-AA-301 found the same in the same setting with abiraterone (14.8 against 10.9 months); PREVAIL moved enzalutamide before chemotherapy."},{"id":"nct07208539","kind":"trial","name":"AG Followed by FOLFIRINOX Both Combined With PD-L1 Antibodies as a Conversion Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer.","aka":["ZSPAC-14"],"tldr":"A phase 2 trial in pancreatic cancer, run by Shanghai Zhongshan Hospital, not yet recruiting.","summary":"AG Followed by FOLFIRINOX Both Combined With PD-L1 Antibodies as a Conversion Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer. is a phase 2, interventional study registered as NCT07208539 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 77 participants, started 2025-10-10 and due to reach its primary completion in 2026-04-09. Interventions recorded: Treatment: AG & anti-PD-L1 + FOLFIRINOX & anti-PD-L1. Conditions listed: Pancreatic Cancer. Primary outcome: 18-month overall survival (OS) rate. Pancreatic eligibility wording from the registry: \"* According to the NCCN Clinical Practice Guidelines for Pancreatic Cancer (2024\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07208539","url":"https://clinicaltrials.gov/study/NCT07208539"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac","locally-advanced-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07208539","phase":"2","setting":"A Prospective, Double-cohort, Multicenter, Phase II Study of Gemcitabine and Albumin Paclitaxel in Combination With PD-L1 Antibodies Followed by Liposomal Irinotecan Combined With Oxaliplatin, 5-FU/LV and PD-L1 Antibodies as Conversion Therapy for Borderline Resectable/Local Advanced Pancreatic Cancer","sponsor":"Shanghai Zhongshan Hospital","started":"2025-10-10","startedType":"estimated","enrolled":77,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06938503","kind":"trial","name":"AG Plus Nimotuzumab Sequential Irreversible Electroporation Ablation for Locally Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of gemcitabine + nab-paclitaxel and nimotuzumab in pancreatic cancer, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"AG Plus Nimotuzumab Sequential Irreversible Electroporation Ablation for Locally Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT06938503 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 48 participants, started 2025-04-21 and due to reach its primary completion in 2028-04-25. Interventions recorded: AG regimen; Nimotuzumab. Conditions listed: Pancreatic Cancer, Adult. Primary outcome: overall survival (OS). Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed pancreatic cancer;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06938503","url":"https://clinicaltrials.gov/study/NCT06938503"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","irreversible-electroporation"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel","nimotuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06938503","phase":"2","setting":"A Prospective, Single-Arm Study of Nab-paclitaxel/Gemcitabine Combined With Nimotuzumab Sequential Irreversible Electroporation Ablation for Locally Advanced Pancreatic Cancer","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2025-04-21","startedType":"estimated","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"agct1531","kind":"trial","name":"AGCT1531","aka":["COG AGCT1531"],"tldr":"AGCT1531 is testing two ways to spare people with germ cell tumours from long-term harm: watching low-risk patients after surgery and giving chemotherapy only if the tumour returns, and swapping cisplatin for carboplatin, which is kinder to hearing, in standard-risk disease; it is still recruiting.","summary":"AGCT1531 is a Children's Oncology Group phase 3 study run with adult cooperative groups for malignant extracranial germ cell tumours from birth to age 50. Low-risk patients (stage I) enter active surveillance after surgery with chemotherapy reserved for relapse. Standard-risk patients are randomised to bleomycin, etoposide and carboplatin or bleomycin, etoposide and cisplatin, with paediatric and adult dosing schedules; the primary endpoints are event-free and overall survival at two years, and ototoxicity is a central secondary endpoint.\n\nThe registry gives an estimated enrolment of 1,780 with a primary completion date of June 2027 and no results. The corpus's childhood germ cell tumour page cites the AGCT1531 stratum for surveillance with chemotherapy only at relapse.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03067181","url":"https://clinicaltrials.gov/study/NCT03067181"}],"tags":["soc-trials"],"related":[],"cancers":["paediatric-germ-cell-tumours","extragonadal-germ-cell-tumour","testicular","childhood-cancers"],"sections":[],"technologies":["active-surveillance","cytotoxic-chemotherapy"],"targets":[],"drugs":["carboplatin","cisplatin","bleomycin","etoposide"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03067181","phase":"3","setting":"Malignant germ cell tumours in children, adolescents and adults up to 50: active surveillance after surgery for low-risk stage I disease, and a randomised comparison of carboplatin against cisplatin with bleomycin and etoposide for standard-risk disease, with hearing loss as a key outcome","sponsor":"Children's Oncology Group","started":"2017-05-25","startedType":"actual","enrolled":1780,"enrolledBasis":"registry","outcomes":[]},{"id":"agex","kind":"trial","name":"AgeX","aka":["The AgeX Trial","ISRCTN33292440"],"tldr":"The largest randomised trial ever run inside a screening programme: nearly four million women cluster-randomised to an extra mammogram below 50 or above 70, and the reason the programme's age range has not moved.","summary":"AgeX is a nationwide cluster-randomised trial run from the University of Oxford inside the NHS Breast Screening Programme in England, testing whether offering one extra screen at 47 to 49, and one at 71 to 73, reduces breast cancer mortality. Its ISRCTN record gives a target of 4,000,000 participants, recruitment from June 2009 to March 2020 and an end date of December 2031: mortality takes that long to read. NHS England's programme overview still describes the age range as 50 up to the 71st birthday and names AgeX as research, so the trial is the reason the boundary has not moved in either direction. Its predecessor, the UK Age trial, randomised women to annual mammography from 40 and reported in 2020 that the mortality benefit was confined to the first ten years and did not persist.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ISRCTN33292440","url":"https://www.isrctn.com/ISRCTN33292440"},{"label":"UK Age trial final results, Lancet Oncology 2020 (DOI)","url":"https://doi.org/10.1016/S1470-2045(20)30398-3"},{"label":"NHS breast screening programme overview","url":"https://www.gov.uk/guidance/breast-screening-programme-overview"}],"tags":["uk","breast","screening"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["mammography"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN33292440","phase":"3","setting":"Screening: cluster-randomised offer of one extra screening round at ages 47 to 49 and one at 71 to 73, inside the NHS Breast Screening Programme in England","sponsor":"University of Oxford","result":"Recruitment closed March 2020; the mortality endpoint is not due until the trial ends in December 2031 (ISRCTN33292440).","yearReported":2020,"enrolled":4000000,"enrolledBasis":"registry","outcomes":[]},{"id":"agile","kind":"trial","name":"AGILE","aka":[],"tldr":"In IDH1-mutated AML, adding ivosidenib to azacitidine tripled survival, one of the largest effects ever seen in a randomised AML trial.","summary":"Event-free survival HR 0.33 (95% CI 0.16-0.69); median OS 24.0 vs 7.9 months (HR 0.44, 95% CI 0.27-0.73); CR 47% vs 15%. Stopped early for benefit. NEJM 2022. Whether ivosidenib-azacitidine or venetoclax-azacitidine (which also works well in IDH-mutant AML) should be first line remains debated; triplets are being tested.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03173248","url":"https://clinicaltrials.gov/study/NCT03173248"},{"label":"NEJM 2022","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2117344"}],"tags":[],"related":[],"cancers":["aml","aml-idh"],"sections":[],"technologies":["epigenetic-drugs","idh-inhibitors","kinase-inhibitors"],"targets":["idh"],"drugs":["ivosidenib","azacitidine"],"companies":["servier"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["courtney-dinardo"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03173248","phase":"3","setting":"Newly diagnosed IDH1-mutated AML unfit for intensive chemotherapy: ivosidenib + azacitidine vs placebo + azacitidine","sponsor":"Agios / Servier","result":"OS 24.0 vs 7.9 months; HR 0.44.","started":"2017-06-26","startedType":"actual","yearReported":2022,"enrolled":146,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival","primary":true,"arms":[{"name":"Ivosidenib + azacitidine","n":72},{"name":"Placebo + azacitidine","n":74}],"hr":0.33,"ci":[0.16,0.69],"p":"0.002","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2117344"},{"endpoint":"Overall survival (median)","unit":"months","arms":[{"name":"Ivosidenib + azacitidine","value":24},{"name":"Placebo + azacitidine","value":7.9}],"hr":0.44,"ci":[0.27,0.73],"source":"https://doi.org/10.1056/NEJMoa2117344"},{"endpoint":"Complete remission","unit":"%","arms":[{"name":"Ivosidenib + azacitidine","value":47},{"name":"Placebo + azacitidine","value":15}],"source":"https://doi.org/10.1056/NEJMoa2117344"}],"replication":"Single-arm ivosidenib-azacitidine (AG120-C-009) and venetoclax-azacitidine IDH subgroup data align; no second randomised trial yet."},{"id":"aurora","kind":"trial","name":"Aglatimagene Besadenovec + Prodrug and Pembrolizumab vs Docetaxel for Stage IV Non-Squamous NSCLC Progressing on Pembrolizumab (AURORA)","aka":["AURORA"],"tldr":"A phase 3 trial testing Aglatimagene besadenovec in non-small-cell lung cancer, now recruiting.","summary":"Aglatimagene Besadenovec + Prodrug and Pembrolizumab vs Docetaxel for Stage IV Non-Squamous NSCLC Progressing on Pembrolizumab (AURORA) is a phase 3 interventional study registered as NCT07660094, led by Candel Therapeutics, and recruiting on the registry. Official title: A Phase 3, Multicenter, Randomised, Controlled, Open-Label Clinical Trial of Aglatimagene Besadenovec (CAN-2409) Plus Prodrug and Pembrolizumab Versus Docetaxel for Stage IV Non-Squamous Non-Small Cell Lung Cancer Progressing on Pembrolizumab-based Treatment. Planned enrolment is 500 participants (estimated). The study started in 2026-06-15 and primary completion is expected in 2031-10-22. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07660094","url":"https://clinicaltrials.gov/study/NCT07660094"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["aglatimagene-besadenovec"],"companies":["candel-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07660094","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Controlled, Open-Label Clinical Trial of Aglatimagene Besadenovec (CAN-2409) Plus Prodrug and Pembrolizumab Versus Docetaxel for Stage IV Non-Squamous Non-Small Cell Lung Cancer Progressing on Pembrolizumab-based Treatment","sponsor":"Candel Therapeutics","started":"2026-06-15","startedType":"estimated","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06638931","kind":"trial","name":"Agnostic Therapy in Rare Solid Tumors","aka":["ANTARES"],"tldr":"A phase 2 trial of nivolumab in gallbladder cancer and other biliary tract cancers, run by Instituto do Cancer do Estado de São Paulo, now recruiting.","summary":"Agnostic Therapy in Rare Solid Tumors is a phase 2 interventional study registered as NCT06638931 by Instituto do Cancer do Estado de São Paulo, with a registry enrolment figure of 28 participants, started 2024-07-16 and due to reach its primary completion in 2026-07. Interventions recorded: Nivolumab. Conditions listed: Urachal Cancer, Parathyroid Carcinoma, Fibrolamellar Carcinoma, Angiosarcoma, Secretory Carcinoma of Breast, Anal Neoplasms, Metaplastic Breast Carcinoma, Translocation Renal Cell Carcinoma, Carcinosarcoma, Small Intestine Neoplasms, Cholangiocarcinoma, Sertoli-Leydig Cell Tumor, Adenoid Cystic Carcinoma, Mesothelioma, Neuroblastoma, Adrenal Gland Neoplasms, Penile Neoplasms, Apocrine Carcinoma, Fibrosarcoma, Cancer of Unknown Primary, Hemangioblastoma, Thyroid Neoplasms, Hepatoblastoma, Fallopian Tube Neoplasms, Leiomyosarcoma, Vaginal Neoplasms, Neurofibrosarcoma, Gallbladder Neoplasms, Osteosarcoma, Biliary Tract Neoplasms, Clear Cell Endometrial Cancer, Yolk Sac Tumor, Vulvar Neoplasms, Kaposi Sarcoma, Ovarian Epithelial Cancer, Soft Tissue Sarcoma, Urethral Neoplasms, Granulosa Cell Tumor, Primitive Neuroectodermal Tumor, Neuroendocrine Tumors, Trophoblastic Tumor. Sites: Brazil. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06638931","url":"https://clinicaltrials.gov/study/NCT06638931"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06638931","phase":"2","setting":"Phase II Basket Study to Evaluate the Tissue-agnostic Efficacy of Anti-Programmed Cell Death Protein 1 (Anti-PD1) Monoclonal Antibody in Patients With Advanced Rare Tumors","sponsor":"Instituto do Cancer do Estado de São Paulo","started":"2024-07-16","startedType":"actual","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"ahl2011","kind":"trial","name":"AHL2011","aka":["AHL2011","Positron emission tomography-adapted de-escalation to ABVD"],"tldr":"Starting with the most intensive Hodgkin chemotherapy and switching to the gentler standard once the scan cleared gave the same results with markedly less anaemia, low platelets and infection.","summary":"AHL2011 took the opposite route from HD18 to the same place. Everyone started with two cycles of escalated BEACOPP. In the standard arm, everyone completed six cycles regardless of the scan. In the scan-driven arm, a negative scan after two cycles meant switching to four cycles of ABVD; a positive scan meant continuing with escalated BEACOPP. 823 patients aged 16 to 60 with stage III, IV or IIB disease with a large mediastinal mass or extranodal involvement were randomised at 90 centres in Belgium and France. 346 of the 410 patients in the scan-driven arm (84 per cent) switched to ABVD.\n\nAt a median follow-up of 50.4 months, five-year progression-free survival by intention to treat was 86.2 per cent (95 per cent confidence interval 81.6 to 89.8) in the standard arm and 85.7 per cent (81.4 to 89.1) in the scan-driven arm (hazard ratio 1.084, 0.737 to 1.596, p = 0.65), which met the non-inferiority margin of 10 points.\n\nThe toxicity difference is where the trial earns its place. Grade 3 to 4 anaemia fell from 69 to 28 per cent, thrombocytopenia from 66 to 40 per cent, febrile neutropenia from 35 to 23 per cent and infections from 22 to 11 per cent. Serious treatment-related adverse events fell from 47 to 28 per cent, and six treatment-related deaths occurred in the standard arm.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT01358747","url":"https://clinicaltrials.gov/study/NCT01358747"},{"label":"Lancet Oncology 2019","url":"https://doi.org/10.1016/S1470-2045(18)30784-8"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["advanced-stage-classical-hodgkin-lymphoma","hodgkin-lymphoma"],"sections":["chemotherapy","imaging"],"technologies":["pet-ct","cytotoxic-chemotherapy"],"targets":[],"drugs":["bleomycin","etoposide","doxorubicin","cyclophosphamide","vincristine","procarbazine","prednisone","vinblastine","dacarbazine"],"companies":["lysa"],"institutions":[],"pathways":[],"terms":["deauville-score","abvd-beacopp","non-inferiority"],"trials":["hd18","hd21","rathl"],"people":[],"bottlenecks":["b-toxicity-qol","b-survivorship"],"keyPapers":["paper-ahl2011-pet-adapted-treatment-advanced-hodgkin-lancet-oncol-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01358747","phase":"3","setting":"Aged 16 to 60 with newly diagnosed advanced Hodgkin lymphoma: six cycles of escalated BEACOPP against a switch to ABVD after a negative scan at two cycles","sponsor":"Centre Hospitalier Universitaire Dijon (LYSA)","result":"Five-year progression-free survival 85.7 against 86.2 per cent when a negative interim scan allowed a switch to ABVD, with grade 3 to 4 anaemia falling from 69 to 28 per cent.","started":"2011-05","yearReported":2019,"enrolled":823,"enrolledBasis":"randomised","enrolledNote":"The ClinicalTrials.gov record carries no enrolment count; 823 patients were randomised in the Lancet Oncology report, 413 to standard treatment and 410 to the scan-driven arm.","outcomes":[{"endpoint":"Progression-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Scan-driven switch to ABVD","n":410,"value":85.7,"note":"95 per cent confidence interval 81.4 to 89.1"},{"name":"Six cycles of escalated BEACOPP","n":413,"value":86.2,"note":"81.6 to 89.8"}],"hr":1.084,"ci":[0.737,1.596],"p":"0.65","source":"https://doi.org/10.1016/S1470-2045(18)30784-8"},{"endpoint":"Grade 3 to 4 anaemia","unit":"%","arms":[{"name":"Scan-driven switch to ABVD","n":407,"value":28},{"name":"Six cycles of escalated BEACOPP","n":413,"value":69}]}],"replication":"Concordant with HD18, which reached the same conclusion by shortening escalated BEACOPP rather than switching regimen."},{"id":"ahod1331","kind":"trial","name":"AHOD1331","aka":["COG AHOD1331"],"tldr":"AHOD1331 showed that replacing bleomycin with the antibody-drug conjugate brentuximab vedotin in the chemotherapy given to children and teenagers with advanced Hodgkin lymphoma cut relapses by more than half without extra side effects, and it became the new standard for high-risk disease.","summary":"AHOD1331 was an open-label Children's Oncology Group phase 3 trial at 153 institutions that randomised 600 patients (587 eligible) aged 2 to 21 with previously untreated high-risk classical Hodgkin lymphoma to five 21-day cycles of brentuximab vedotin with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide, or to the standard paediatric ABVE-PC regimen. Involved-site radiotherapy was given after cycle five to slow-responding lesions on central PET review and to large mediastinal disease. The primary endpoint was event-free survival.\n\nAt a median follow-up of 42.1 months three-year event-free survival was 92.1 percent with brentuximab vedotin against 82.5 percent with standard care (hazard ratio 0.41), with similar toxicity and similar use of radiotherapy (53.4 against 56.8 percent); three-year overall survival was 99.3 and 98.5 percent. Brentuximab vedotin was approved in the United States in November 2022 for paediatric high-risk classical Hodgkin lymphoma on this trial. The corpus's Hodgkin lymphoma page cites AHOD1331 for ABVE-PC with brentuximab and PET-guided radiotherapy omission.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02166463","url":"https://clinicaltrials.gov/study/NCT02166463"}],"tags":["soc-trials"],"related":[],"cancers":["hodgkin-lymphoma","advanced-stage-classical-hodgkin-lymphoma","childhood-cancers"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy"],"targets":[],"drugs":["brentuximab-vedotin","doxorubicin","vincristine","etoposide","prednisone","cyclophosphamide","bleomycin"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-ahod1331-brentuximab-vedotin-paediatric-hodgkin-castellino-nejm-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02166463","phase":"3","setting":"Newly diagnosed high-risk classical Hodgkin lymphoma (stage IIB with bulk, IIIB, IVA or IVB) in patients aged 2 to 21: five cycles of brentuximab vedotin with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide against standard ABVE-PC, with PET-guided involved-site radiotherapy for slow-responding lesions","sponsor":"National Cancer Institute (NCI)","result":"Three-year event-free survival 92.1 percent with brentuximab vedotin plus AVEPC against 82.5 percent with ABVE-PC (hazard ratio 0.41, p < 0.001), with no increase in toxicity; approved for children in the United States in November 2022.","started":"2015-03-19","startedType":"actual","yearReported":2022,"enrolled":600,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Brentuximab vedotin + doxorubicin, vincristine, etoposide, prednisone, cyclophosphamide","value":92.1,"note":"95% CI 88.4 to 94.7; 587 eligible of 600 randomised; median follow-up 42.1 months"},{"name":"ABVE-PC (standard care)","value":82.5,"note":"95% CI 77.4 to 86.5"}],"hr":0.41,"ci":[0.25,0.67],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa2206660"},{"endpoint":"Overall survival at 3 years","unit":"%","arms":[{"name":"Brentuximab vedotin + AVEPC","value":99.3,"note":"95% CI 97.3 to 99.8"},{"name":"ABVE-PC (standard care)","value":98.5,"note":"95% CI 96.0 to 99.4"}],"source":"https://doi.org/10.1056/NEJMoa2206660"},{"endpoint":"Patients given involved-site radiotherapy","unit":"%","arms":[{"name":"Brentuximab vedotin + AVEPC","value":53.4},{"name":"ABVE-PC (standard care)","value":56.8}],"source":"https://doi.org/10.1056/NEJMoa2206660"}]},{"id":"ahod2131","kind":"trial","name":"AHOD2131 (COG / NCTN)","aka":[],"tldr":"Asks whether early-stage Hodgkin lymphoma in children and adults can be treated with immunotherapy instead of some chemotherapy and radiation.","summary":"AHOD2131, trial NCT05675410 run by the Children's Oncology Group and the NCI, asks whether early-stage classical Hodgkin lymphoma in children and adults aged 5 to 60 can be treated with brentuximab vedotin plus nivolumab in a response-adapted design, instead of some chemotherapy and radiation. It uses PET after two cycles to steer therapy, has progression-free survival as its primary endpoint, measures late effects, and is ongoing with no results yet. OnCo links it to Hodgkin lymphoma, PET-adapted therapy, brentuximab vedotin, nivolumab, the Children's Oncology Group, Kara M. Kelly, the idea of chemotherapy-free early-stage Hodgkin treatment and the S1826 paper. Whether immunotherapy can spare young patients the late effects of chemotherapy and radiation without losing cures is the question it exists to answer.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05675410","url":"https://clinicaltrials.gov/study/NCT05675410"}],"tags":[],"related":[],"cancers":["hodgkin-lymphoma","early-stage-classical-hodgkin-lymphoma"],"sections":[],"technologies":["pet-adapted-therapy"],"targets":[],"drugs":["brentuximab-vedotin","nivolumab","fludeoxyglucose-f18"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["kara-kelly"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05675410","phase":"3","setting":"Newly diagnosed stage I-II classical Hodgkin lymphoma, age 5-60: standard therapy vs brentuximab vedotin + nivolumab (response-adapted), with or without radiation","sponsor":"Children's Oncology Group / NCI","started":"2023-05-11","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"nct06600022","kind":"trial","name":"Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours.","aka":[],"tldr":"A phase 1/2 trial of SCTB41 in advanced solid tumours, run by Sinocelltech Ltd., now recruiting.","summary":"Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours. is a phase 1/2 interventional study registered as NCT06600022 by Sinocelltech Ltd., with 441 participants planned, started 2024-10-10 and due to reach its primary completion in 2027-04-30. Interventions recorded: SCTB41.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06600022","url":"https://clinicaltrials.gov/study/NCT06600022"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["sctb41"],"companies":["sinocelltech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06600022","phase":"1/2","setting":"A Phase I/II, Open-label, Multicentre, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SCTB41 in Patients with Advanced Malignant Solid Tumours","sponsor":"Sinocelltech Ltd.","started":"2024-10-10","startedType":"actual","enrolled":441,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05932212","kind":"trial","name":"AK104 for Recurrent or Metastatic Vulvar Cancer","aka":[],"tldr":"A phase 2 trial of Cadonilimab, Paclitaxel / nab-paclitaxel in vulvar cancer, run by Akeso, now recruiting.","summary":"AK104 for Recurrent or Metastatic Vulvar Cancer is a phase 2 interventional study registered as NCT05932212 by Akeso, with 20 participants planned, started 2023-08-25 and due to reach its primary completion in 2025-12-15. Interventions recorded: AK104, AK104+ Paclitaxel+Cisplatin or Carboplatin. Conditions listed: Vulvar Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05932212","url":"https://clinicaltrials.gov/study/NCT05932212"}],"tags":["ctgov-ingest"],"related":[],"cancers":["vulvar","hpv-associated-vulvar-cancer","hpv-independent-vulvar-cancer"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["cadonilimab","paclitaxel"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05932212","phase":"2","setting":"A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer","sponsor":"Akeso","started":"2023-08-25","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07544784","kind":"trial","name":"AK104 Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS CRLM (APSOC)","aka":["APSOC"],"tldr":"A phase 2 trial of cadonilimab in colorectal cancer, run by Fudan University, now recruiting.","summary":"AK104 Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS CRLM (APSOC) is a phase 2, randomised interventional study registered as NCT07544784 by Fudan University, with a registry enrolment figure of 73 participants, started 2025-11-04 and due to reach its primary completion in 2027-12-01. Interventions recorded: AK104 with radiotherapy; Standard of therapy. Conditions listed: Colorectal Cancer Liver Metastases (CRLM). Primary outcome: ORR. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed colorectal cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07544784","url":"https://clinicaltrials.gov/study/NCT07544784"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["cadonilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07544784","phase":"2","setting":"Efficacy of Cadonilimab (AK104) Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS Colorectal Cancer With Liver Metastases: A Prospective, Randomized Controlled, Single-Center Phase II Clinical Trial (APSOC)","sponsor":"Fudan University","started":"2025-11-04","startedType":"actual","enrolled":73,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05904379","kind":"trial","name":"AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of Ivonescimab, Cadonilimab, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Akeso, active and no longer recruiting.","summary":"AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT05904379 by Akeso, with 233 participants planned, started 2023-07-13 and due to reach its primary completion in 2026-06-30. Interventions recorded: AK112, AK104, Carboplatin, paclitaxel, pemetrexed. Conditions listed: Advanced Non-small-cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05904379","url":"https://clinicaltrials.gov/study/NCT05904379"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab","cadonilimab","carboplatin","paclitaxel","pemetrexed","docetaxel"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05904379","phase":"1/2","setting":"A Phase Ib/II Clinical Trial of AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer","sponsor":"Akeso","started":"2023-07-13","startedType":"actual","enrolled":233,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06646055","kind":"trial","name":"AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of Ivonescimab, Cadonilimab, Paclitaxel / nab-paclitaxel in pancreatic ductal adenocarcinoma, run by Akeso, active and no longer recruiting.","summary":"AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer is a phase 1/2 interventional study registered as NCT06646055 by Akeso, with 110 participants planned, started 2025-01-21 and due to reach its primary completion in 2026-12-30. Interventions recorded: AK112, Cadonilimab, nab-paclitaxel, gemcitabine, AK112, Cadonilimab, nab-paclitaxel, gemcitabine, AK112, Cadonilimab, nab-paclitaxel, gemcitabine, AK112, nab-paclitaxel, gemcitabine, nab-paclitaxel, gemcitabine. Conditions listed: Metastatic Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06646055","url":"https://clinicaltrials.gov/study/NCT06646055"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab","cadonilimab","paclitaxel","gemcitabine"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06646055","phase":"1/2","setting":"A Phase Ib/II Clinical Study of AK112 and Cadonilimab Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer","sponsor":"Akeso","started":"2025-01-21","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06951503","kind":"trial","name":"AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 3 trial of Oxaliplatin and Bevacizumab in colorectal cancer, run by Akeso, now recruiting.","summary":"AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer is a phase 3 interventional study registered as NCT06951503 by Akeso, with 560 participants planned, started 2025-05-27 and due to reach its primary completion in 2027-01-13. Interventions recorded: AK112, Oxaliplatin, Irinotecan, Leucovorin and 5-FU and Bevacizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06951503","url":"https://clinicaltrials.gov/study/NCT06951503"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["oxaliplatin","bevacizumab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06951503","phase":"3","setting":"A Randomized, Controlled, Multicenter Phase III Clinical Study of AK112 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy in First-line Metastatic Colorectal Cancer","sponsor":"Akeso","started":"2025-05-27","startedType":"actual","enrolled":560,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06591520","kind":"trial","name":"AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 3 trial of Cisplatin, Gemcitabine, Gemcitabine + cisplatin and Durvalumab in biliary tract cancer, run by Akeso, active and no longer recruiting.","summary":"AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer is a phase 3 interventional study registered as NCT06591520 by Akeso, with 682 participants enrolled, started 2024-10-20 and due to reach its primary completion in 2026-10. Interventions recorded: AK112, Gemcitabine, Cisplatin and Durvalumab, Gemcitabine, Cisplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06591520","url":"https://clinicaltrials.gov/study/NCT06591520"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin","gemcitabine","gemcitabine-cisplatin","durvalumab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06591520","phase":"3","setting":"A Randomized, Controlled, Multi-center Phase III Study of AK112 Combined With Gemcitabine Plus Cisplatin Versus Durvalumab Combined With Gemcitabine Plus Cisplatin as the First-line Treatment for Patients With Advanced Biliary Tract Cancer","sponsor":"Akeso","started":"2024-10-20","startedType":"actual","enrolled":682,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07767994","kind":"trial","name":"AK112 Combined With GAP Conversion Therapy for Locally Advanced Gallbladder Cancer","aka":["ICORE-GBC"],"tldr":"A phase 2 trial of ivonescimab, gemcitabine, cisplatin and nab-paclitaxel in gallbladder cancer and other biliary tract cancers, run by First Affiliated Hospital Xi'an Jiaotong University, not yet recruiting.","summary":"AK112 Combined With GAP Conversion Therapy for Locally Advanced Gallbladder Cancer is a phase 2 interventional study registered as NCT07767994 by First Affiliated Hospital Xi'an Jiaotong University, with a registry enrolment figure of 22 participants, started 2026-08-28 and due to reach its primary completion in 2028-06-30. Interventions recorded: AK112, Gemcitabine, Cisplatin, Albumin-Bound Paclitaxel /nab-Paclitaxel. Conditions listed: Gallbladder Cancer. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07767994","url":"https://clinicaltrials.gov/study/NCT07767994"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["ivonescimab","gemcitabine","cisplatin","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07767994","phase":"2","setting":"Single-Center, Single-Arm, Two-Stage, Prospective Phase II Clinical Study of AK112 Combined With GAP Regimen as Conversion Therapy for Locally Advanced Gallbladder Cancer","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","started":"2026-08-28","startedType":"estimated","enrolled":22,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05840016","kind":"trial","name":"AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of Ivonescimab, Carboplatin, Tislelizumab in non-small-cell lung cancer and small-cell lung cancer, run by Akeso, active and no longer recruiting.","summary":"AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT05840016 by Akeso, with 532 participants enrolled, started 2023-08-17 and due to reach its primary completion in 2025-02-28. Interventions recorded: AK112, Carboplatin, Paxlitaxel, Tislelizumab, Carboplatin, Paxlitaxel. Conditions listed: Advanced Squamous Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05840016","url":"https://clinicaltrials.gov/study/NCT05840016"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ivonescimab","carboplatin","tislelizumab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05840016-lancet-2025","paper-nct05840016-lancet-2026-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05840016","phase":"3","setting":"A Randomized, Controlled, Multi-center Phase III Clinical Study of AK112 Combined With Chemotherapy Versus PD-1 Inhibitor Combined With Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer","sponsor":"Akeso","started":"2023-08-17","startedType":"actual","enrolled":532,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07158840","kind":"trial","name":"AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC)Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor","aka":["AGA TKI NSCLC"],"tldr":"A phase 2 trial of ivonescimab in lung cancer, run by Akeso, not yet recruiting.","summary":"AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC)Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor (TKI) Treatment is a phase 2, interventional study registered as NCT07158840 by Akeso, with a registry enrolment figure of 60 participants, started 2025-09-05 and due to reach its primary completion in 2028-09. Interventions recorded: AK112. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Overall response (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07158840","url":"https://clinicaltrials.gov/study/NCT07158840"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07158840","phase":"2","setting":"A Single Arm, Multi-center, Phase II Study of AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC) Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor (TKI) Treatment","sponsor":"Akeso","started":"2025-09-05","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05247684","kind":"trial","name":"AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC","aka":[],"tldr":"A phase 2 trial of Ivonescimab, Carboplatin, Cisplatin in non-small-cell lung cancer and small-cell lung cancer, run by Akeso, active and no longer recruiting.","summary":"AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC is a phase 2 interventional study registered as NCT05247684 by Akeso, with 90 participants enrolled, started 2022-02-20 and due to reach its primary completion in 2025-08-18. Interventions recorded: AK112, Carboplatin, Cisplatin, Paclitaxel. Conditions listed: Resectable Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05247684","url":"https://clinicaltrials.gov/study/NCT05247684"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ivonescimab","carboplatin","cisplatin","paclitaxel"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05247684","phase":"2","setting":"Phase II Clinical Study of AK112, an Anti-PD-1 and VEGF Bispecific Antibody, Alone or in Combination With Chemotherapy for the Neoadjuvant/Adjuvant Treatment of Resectable Non-small Cell Lung Cancer","sponsor":"Akeso","started":"2022-02-20","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06767527","kind":"trial","name":"AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer","aka":[],"tldr":"A phase 3 trial of Ivonescimab, Paclitaxel / nab-paclitaxel in triple-negative breast cancer, run by Akeso, now recruiting.","summary":"AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer is a phase 3 interventional study registered as NCT06767527 by Akeso, with 416 participants planned, started 2025-02-07 and due to reach its primary completion in 2026-12. Interventions recorded: AK112, Nab-paclitaxel, Placebo. Conditions listed: Triple-Negative Breast Cancer (TNBC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06767527","url":"https://clinicaltrials.gov/study/NCT06767527"}],"tags":["ctgov-ingest"],"related":[],"cancers":["tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":["ivonescimab","paclitaxel"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06767527","phase":"3","setting":"A Randomized, Controlled, Multi-center Phase III Clinical Study of AK112 Plus Nab-paclitaxel Versus Placebo Plus Nab-paclitaxel as First-line Treatment for Locally Advanced Unresectable or Metastatic Triple-negative Breast Cancer","sponsor":"Akeso","started":"2025-02-07","startedType":"actual","enrolled":416,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07021950","kind":"trial","name":"AK112 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI as Second-line Treatment of MSS/pMMR Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of ivonescimab, fOLFIRI (5-FU, leucovorin, irinotecan) and bevacizumab (glioblastoma use) in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"AK112 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI as Second-line Treatment of MSS/pMMR Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07021950 by Sun Yat-sen University, with a registry enrolment figure of 130 participants, started 2025-08-10 and due to reach its primary completion in 2027-10-31. Interventions recorded: AK112; FOLFIRI; Bevacizumab. Conditions listed: Colorectal Cancer; Ivonescimab. Primary outcome: PFS. Colorectal eligibility wording from the registry: \"Pathologically confirmed locally advanced unresectable or metastatic colorectal adenocarcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07021950","url":"https://clinicaltrials.gov/study/NCT07021950"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["ivonescimab","folfiri","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07021950","phase":"2","setting":"Ivonescimab (AK112) Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI as Second-line Treatment of MSS/pMMR Metastatic Colorectal Cancer: a Randomized, Controlled, Multicenter Phase II Study","sponsor":"Sun Yat-sen University","started":"2025-08-10","startedType":"estimated","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06943820","kind":"trial","name":"AK129 Combination Therapy for Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pemetrexed, Paclitaxel / nab-paclitaxel, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Akeso, now recruiting.","summary":"AK129 Combination Therapy for Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06943820 by Akeso, with 230 participants planned, started 2025-05-21 and due to reach its primary completion in 2026-12. Interventions recorded: AK129(dose 1), Pemetrexed, Paclitaxel, Carboplatin, AK129(dose 2). Conditions listed: Non-small Cell Lung Cancer Stage IIIB/IV, Head and Neck Squamous Cell Carcinoma (HNSCC), Colorectal Adenocarcinoma, Advanced Solid Tumors. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06943820","url":"https://clinicaltrials.gov/study/NCT06943820"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":["pemetrexed","paclitaxel","carboplatin","docetaxel","flot","cetuximab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06943820","phase":"1/2","setting":"A Phase Ib/II Study of Anti-PD-1/LAG-3 Bispecific Antibody AK129 Combinations in Advanced Solid Tumors","sponsor":"Akeso","started":"2025-05-21","startedType":"actual","enrolled":230,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03386617","kind":"trial","name":"AKY15-HK-301_NEPA Study","aka":[],"tldr":"A phase 2 trial of Netupitant and palonosetron in Breast cancer, run by Chinese University of Hong Kong, active and no longer recruiting.","summary":"AKY15-HK-301_NEPA Study is a phase 2 interventional study registered as NCT03386617 by Chinese University of Hong Kong, with 55 participants planned, started 2018-02-27 and due to reach its primary completion in 2027-12-31. Interventions recorded: NEPA. Conditions recorded: Breast Cancer.\n\nLinked to the drug Netupitant and palonosetron because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03386617","url":"https://clinicaltrials.gov/study/NCT03386617"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["netupitant-palonosetron"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03386617","phase":"2","setting":"Open Label Single Arm Study for NEPA [Oral Fixed-dose Combination of 300 mg Netupitant and 0.50 mg Palonosetron] in Hong Kong Oncology Patients Receiving (Neo)-Adjuvant Chemotherapy Treatment Consists of Adriamycin and Cyclophosphamide for Breast Cancer","sponsor":"Chinese University of Hong Kong","started":"2018-02-27","startedType":"actual","enrolled":55,"enrolledBasis":"registry","outcomes":[]},{"id":"alascca","kind":"trial","name":"ALASCCA","aka":[],"tldr":"A Nordic trial showing that three years of low-dose aspirin roughly halves recurrence in bowel cancers carrying a particular set of mutations, a biomarker-directed use of a drug that costs pennies.","summary":"3,508 patients were screened for tumour PIK3CA and PI3K-pathway alterations; 626 with alterations were randomised. In group A (PIK3CA exon 9 or 20 hotspot mutations, n=314) recurrence at three years was 7.7% with aspirin vs 14.1% with placebo (HR 0.49, 95% CI 0.24-0.98); in group B (other PIK3CA mutations or PIK3R1/PTEN alterations, n=312) it was 7.7% vs 16.8% (HR 0.42, 95% CI 0.21-0.83). Severe adverse events attributable to aspirin were uncommon (about 2%). ALASCCA validates a decade of observational data from the Nurses' Health Study and CALGB 89803 suggesting PIK3CA-mutant tumours are aspirin-sensitive, and creates an implementation task: routine PIK3CA testing in early colorectal cancer, which most pathology services do not currently perform.","status":"positive","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT02647099","url":"https://clinicaltrials.gov/study/NCT02647099"},{"label":"Martling et al. (NEJM 2025)","url":"https://doi.org/10.1056/NEJMoa2504650"}],"tags":[],"related":["idea-reg-aspirin-pik3ca-implementation"],"cancers":["colorectal"],"sections":["nutrition-lifestyle","prevention"],"technologies":["aspirin-cancer-prevention","drug-repurposing","ngs"],"targets":["pik3ca"],"drugs":["aspirin"],"companies":[],"institutions":["karolinska"],"pathways":["pi3k-akt-mtor"],"terms":["germline-vs-somatic"],"trials":[],"people":[],"bottlenecks":["b-generic-repurposing","b-knowledge-diffusion"],"keyPapers":["paper-alascca-n-engl-j-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02647099","phase":"3","setting":"Resected stage I-III rectal or stage II-III colon cancer with somatic PIK3CA (exon 9/20) or other PI3K-pathway alterations: aspirin 160 mg/day for 3 years vs placebo","sponsor":"Karolinska Institutet","result":"3-year recurrence HR 0.49 (PIK3CA hotspot) and 0.42 (other PI3K alterations).","started":"2016-04-07","startedType":"actual","yearReported":2025,"enrolled":626,"enrolledBasis":"registry","outcomes":[{"endpoint":"Time to recurrence at 3 years, group A (PIK3CA exon 9/20)","primary":true,"unit":"%","arms":[{"name":"Aspirin","value":7.7},{"name":"Placebo","value":14.1}],"hr":0.49,"ci":[0.24,0.98],"source":"https://doi.org/10.1056/NEJMoa2504650"},{"endpoint":"Time to recurrence at 3 years, group B (other PI3K-pathway alterations)","unit":"%","arms":[{"name":"Aspirin","value":7.7},{"name":"Placebo","value":16.8}],"hr":0.42,"ci":[0.21,0.83],"source":"https://doi.org/10.1056/NEJMoa2504650"}],"replication":"Awaits confirmation; the ADD-ASPIRIN trial includes a pre-planned PIK3CA analysis. Observational cohorts are concordant."},{"id":"nct07831330","kind":"trial","name":"Albumin-bound Paclitaxel (II) in Combination With Gemcitabine as First Line Therapy for Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of nab-paclitaxel and gemcitabine in pancreatic cancer, run by The First Affiliated Hospital with Nanjing Medical University, not yet recruiting.","summary":"Albumin-bound Paclitaxel (II) in Combination With Gemcitabine as First Line Therapy for Metastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT07831330 by The First Affiliated Hospital with Nanjing Medical University, with a registry enrolment figure of 59 participants, started 2026-09-05 and due to reach its primary completion in 2029-01-31. Interventions recorded: Albumin-bound Paclitaxel (II) + Gemcitabine. Conditions listed: Metastatic Pancreatic Adenocarcinoma; Albumin-bound Paclitaxel (II); Gemcitabine; First-Line. Primary outcome: Objective Response Rate(ORR). Pancreatic eligibility wording from the registry: \"Histopathologically or cytologically confirmed metastatic pancreatic adenocarcinoma ; 3\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07831330","url":"https://clinicaltrials.gov/study/NCT07831330"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["nab-paclitaxel","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07831330","phase":"2","setting":"Albumin-bound Paclitaxel (II) in Combination With Gemcitabine as First Line Therapy for Metastatic Pancreatic Cancer: A Multicenter, Single-Arm Study","sponsor":"The First Affiliated Hospital with Nanjing Medical University","started":"2026-09-05","startedType":"estimated","enrolled":59,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07828756","kind":"trial","name":"Albumin-bound Paclitaxel (II)-Combined Regimens for Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of cisplatin, nab-paclitaxel, capecitabine and gemcitabine in pancreatic cancer, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"Albumin-bound Paclitaxel (II)-Combined Regimens for Pancreatic Cancer is a phase 2, interventional study registered as NCT07828756 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 147 participants, started 2026-09-30 and due to reach its primary completion in 2027-10-31. Interventions recorded: Cisplatin; Albumin-bound Paclitaxel (II); Albumin-bound Paclitaxel (II); Capecitabine; Capecitabine; Gemcitabine; Gemcitabine. Conditions listed: Pancreatic Cancer. Primary outcome: Progression-Free Survival (PFS); 1-Year Event-Free Survival Rate (1y-EFS Rate); Recommended Phase 2 Dose (RP2D). Pancreatic eligibility wording from the registry: \"* Histopathologically confirmed pancreatic adenocarcinoma meeting any one of the following conditions: (1) Unresectable locally advanced or metastatic pancreatic cancer, with no prior systemic anti-tumor therapy for advanced disease\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07828756","url":"https://clinicaltrials.gov/study/NCT07828756"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin","nab-paclitaxel","capecitabine","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07828756","phase":"2","setting":"A Multi-cohort Exploratory Study to Evaluate the Efficacy and Safety of Albumin-bound Paclitaxel (II)-Combined Regimens for Pancreatic Cancer","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2026-09-30","startedType":"estimated","enrolled":147,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06789679","kind":"trial","name":"Albumin-Bound Paclitaxel and Gemcitabine With or Without S-1 as First-Line Treatment for Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"Albumin-Bound Paclitaxel and Gemcitabine With or Without S-1 as First-Line Treatment for Advanced Pancreatic Cancer is a phase 2, randomised interventional study registered as NCT06789679 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 128 participants, started 2025-01-25 and due to reach its primary completion in 2026-06-30. Interventions recorded: Gemcitabine, albumin-bound paclitaxel, S-1; Gemcitabine, albumin-bound paclitaxel. Conditions listed: Pancreatic Adenocarcinoma. Primary outcome: Objective Response Rate (ORR). Pancreatic eligibility wording from the registry: \"The participant must have a pathological diagnosis of pancreatic ductal adenocarcinoma (including adenosquamous carcinoma)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06789679","url":"https://clinicaltrials.gov/study/NCT06789679"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06789679","phase":"2","setting":"Randomized Phase II Clinical Study of Albumin-Bound Paclitaxel and Gemcitabine With or Without S-1 as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Cancer","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2025-01-25","startedType":"actual","enrolled":128,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05192798","kind":"trial","name":"Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic TNBC","aka":[],"tldr":"A phase 2 trial of nab-paclitaxel, rivoceranib (apatinib) and bevacizumab in triple-negative breast cancer, run by The First Affiliated Hospital of Bengbu Medical University, now recruiting.","summary":"Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic TNBC is a phase 2, randomised interventional study registered as NCT05192798 by The First Affiliated Hospital of Bengbu Medical University, with a registry enrolment figure of 128 participants, started 2022-01-14 and due to reach its primary completion in 2027-09-10. Interventions recorded: Albumin-Bound Paclitaxel; Apatinib Mesylate; Bevacizumab. Conditions listed: Triple-negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Patients with recurrent or metastatic triple negative breast cancer confirmed by histopathology and imaging;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05192798","url":"https://clinicaltrials.gov/study/NCT05192798"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["nab-paclitaxel","rivoceranib","bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05192798","phase":"2","setting":"A Prospective, Randomized, Open Label Clinical Study Evaluating Efficacy and Safety of Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic Triple Negative Breast Cancer","sponsor":"The First Affiliated Hospital of Bengbu Medical University","started":"2022-01-14","startedType":"actual","enrolled":128,"enrolledBasis":"registry","outcomes":[]},{"id":"alcanza","kind":"trial","name":"ALCANZA","aka":[],"tldr":"ALCANZA showed that brentuximab vedotin produced lasting improvement in the skin disease of far more people with CD30-positive cutaneous T-cell lymphoma than the standard tablets methotrexate or bexarotene.","summary":"ALCANZA was an open-label phase 3 trial of 131 patients with CD30-expressing mycosis fungoides or primary cutaneous anaplastic large cell lymphoma who had received at least one prior systemic therapy. They were randomised to brentuximab vedotin every three weeks for up to 16 cycles or to the physician's choice of oral methotrexate or bexarotene. The primary endpoint was the rate of objective response lasting at least four months.\n\nThe durable response rate was several times higher with brentuximab vedotin, with longer progression-free survival and better symptom scores, at the cost of more peripheral neuropathy. It was approved in the United States in November 2017 for these two cutaneous T-cell lymphomas after prior systemic therapy, the first new drug for the disease shown superior to a standard in a randomised trial.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01578499","url":"https://clinicaltrials.gov/study/NCT01578499"}],"tags":["subtype-trials"],"related":["lymphoma-roadmap","lymphoma-ev-randomised-evidence-for-the-t-cell-lymphomas"],"cancers":["cutaneous-t-cell-lymphoma","peripheral-t-cell-lymphoma"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["brentuximab-vedotin","methotrexate","bexarotene"],"companies":["takeda","pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["miles-prince"],"bottlenecks":[],"keyPapers":["paper-alcanza-brentuximab-vedotin-lancet-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01578499","phase":"3","setting":"Previously treated CD30-positive cutaneous T-cell lymphoma (mycosis fungoides or primary cutaneous anaplastic large cell lymphoma): brentuximab vedotin against physician's choice of methotrexate or bexarotene","sponsor":"Millennium Pharmaceuticals (Takeda)","result":"Brentuximab vedotin produced far more objective responses lasting at least four months than methotrexate or bexarotene; approved in November 2017.","started":"2012-06-11","startedType":"actual","yearReported":2017,"enrolled":131,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective global response lasting at least 4 months (independent review)","primary":true,"unit":"%","arms":[{"name":"Brentuximab vedotin","n":64,"value":56.3,"note":"Median follow-up 22.9 months"},{"name":"Physician's choice (methotrexate or bexarotene)","n":64,"value":12.5}],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(17)31266-7"},{"endpoint":"Grade 3-4 adverse events","unit":"%","arms":[{"name":"Brentuximab vedotin","n":66,"value":41},{"name":"Physician's choice (methotrexate or bexarotene)","n":62,"value":47}],"source":"https://doi.org/10.1016/S0140-6736(17)31266-7"}]},{"id":"alchemist","kind":"trial","name":"ALCHEMIST (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials)","aka":["ALCHEMIST screening","A151216","ALCHEMIST trials"],"tldr":"ALCHEMIST tests thousands of people whose early lung cancer has just been removed, finds the small fraction with an EGFR or ALK change, and offers them a trial of the matching pill after surgery, with everyone else offered an immunotherapy trial. It is the adjuvant version of a lung cancer umbrella trial.","summary":"ALCHEMIST opened in 2014 as three linked NCI trials. The screening protocol A151216 collects tumour and blood from patients with completely resected stage IB to IIIA non-squamous (later also squamous) non-small-cell lung cancer, tests centrally for EGFR mutations and ALK rearrangements, and follows everyone for recurrence with periodic re-sequencing. Patients with an EGFR mutation were offered A081105, erlotinib for two years against placebo after standard adjuvant chemotherapy; those with an ALK rearrangement were offered E4512, crizotinib against observation; and from 2016 those with neither were offered ANVIL (EA5142), a year of nivolumab against observation. A later chemo-immunotherapy trial, ACCIO, joined the family.\n\nThe platform has recruited several thousand patients and its treatment trials have all completed or closed to accrual. The strategic question it was built to answer, whether a targeted adjuvant drug prevents relapse in EGFR- and ALK-driven early lung cancer, was answered first by industry trials with newer drugs: ADAURA showed osimertinib prolongs disease-free and overall survival after EGFR-mutant resection and won approval in 2020, and ALINA did the same for alectinib in ALK-positive disease with approval in 2024. Both changed the standard of care while ALCHEMIST was still following its patients, so its erlotinib and crizotinib comparisons are now read as evidence about older drugs and about the natural history of resected driver-positive disease.\n\nWhat ALCHEMIST has already delivered is the largest prospectively sequenced cohort of resected lung cancer with long follow-up, a template for adjuvant umbrella trials, and the demonstration that routine molecular testing after surgery is feasible across community sites in the United States. Its remaining value lies in its biobank, in the ANVIL immunotherapy comparison and in the recurrence samples that show how driver-positive cancers evolve after surgery.","status":"active","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02194738","url":"https://clinicaltrials.gov/study/NCT02194738"},{"label":"ClinicalTrials.gov NCT02193282: A081105, adjuvant erlotinib","url":"https://clinicaltrials.gov/study/NCT02193282"},{"label":"ClinicalTrials.gov NCT02201992: E4512, adjuvant crizotinib","url":"https://clinicaltrials.gov/study/NCT02201992"},{"label":"ClinicalTrials.gov NCT02595944: ANVIL (EA5142), adjuvant nivolumab","url":"https://clinicaltrials.gov/study/NCT02595944"},{"label":"NCI: the ALCHEMIST lung cancer trials","url":"https://www.cancer.gov/types/lung/research/alchemist"}],"tags":[],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":["cgp","histopathology-ihc","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["erlotinib","crizotinib","nivolumab","osimertinib","alectinib"],"companies":["alliance-oncology","ecog-acrin","swog","nrg-oncology"],"institutions":["nci"],"pathways":[],"terms":["master-protocol","neoadjuvant-adjuvant","basket-umbrella-platform"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-alchemist-jama-oncol-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02194738","phase":"platform","setting":"Completely resected stage IB to IIIA non-small-cell lung cancer: central testing for EGFR mutations, ALK rearrangements and later PD-L1 feeds randomised adjuvant trials of erlotinib, crizotinib and nivolumab against observation or placebo","sponsor":"National Cancer Institute with the Alliance, ECOG-ACRIN, SWOG and NRG Oncology","result":"Screening and adjuvant trials completed accrual; the EGFR and ALK adjuvant questions were settled in practice by ADAURA (osimertinib) and ALINA (alectinib) while ALCHEMIST follow-up continues.","started":"2014-09-26","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"aldoxorubicin-phase-3-sts","kind":"trial","name":"Aldoxorubicin versus investigator's choice in relapsed or refractory soft tissue sarcoma","aka":[],"tldr":"The phase 3 that was meant to bring the tumour-targeted doxorubicin aldoxorubicin to market: it did not meet its primary endpoint of progression-free survival.","summary":"433 patients with previously treated soft tissue sarcoma were randomised to aldoxorubicin or one of five investigator-chosen standard treatments. The trial did not meet its primary endpoint of progression-free survival by blinded central review, as the sponsor announced in 2016, although secondary analyses reported by the sponsor favoured aldoxorubicin in leiomyosarcoma and liposarcoma and in the primary analysis by investigator assessment. CytRx licensed the drug to ImmunityBio in 2017, and Gemini Therapeutics is now pursuing its development with integrated analyses of the randomised sarcoma studies presented at ASCO 2026.","status":"negative","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT02049905","url":"https://clinicaltrials.gov/study/NCT02049905"},{"label":"Chawla et al., phase 2b first-line trial (JAMA Oncology 2015)","url":"https://doi.org/10.1001/jamaoncol.2015.3101"}],"tags":["owner-request"],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["aldoxorubicin","doxorubicin","pazopanib","gemcitabine","docetaxel","ifosfamide","dacarbazine"],"companies":["immunitybio","gemini-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-chawla-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02049905","phase":"3","setting":"Metastatic, locally advanced or unresectable soft tissue sarcoma after at least one prior systemic therapy, randomised against investigator's choice of dacarbazine, pazopanib, gemcitabine with docetaxel, doxorubicin or ifosfamide; started January 2014","sponsor":"CytRx (now ImmunityBio)","started":"2014-01","enrolled":433,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Aldoxorubicin","n":218,"value":4.04,"note":"Registry results section: medians with 95% CI 2.79-4.83 vs 2.63-4.17; no hazard ratio posted and no primary publication found"},{"name":"Investigator's choice of treatment","n":215,"value":2.96}],"source":"https://clinicaltrials.gov/study/NCT02049905"}]},{"id":"alesia","kind":"trial","name":"ALESIA","aka":[],"tldr":"Repeated the ALEX trial in Chinese, Korean and Thai patients at the Western dose, and found the same answer.","summary":"ALEX had established alectinib as the first-line ALK inhibitor, but it used 600 mg twice daily, whereas Japan had approved 300 mg twice daily, and there was a question about whether the Western dose and the Western result transferred to Asian populations. ALESIA randomised 187 Asian patients at 21 sites in China, South Korea and Thailand 2:1 to alectinib 600 mg twice daily (125 patients) or crizotinib 250 mg twice daily (62), stratified by performance status and baseline central nervous system metastases, with asymptomatic brain metastases permitted.\n\nAt a median follow-up of 16.2 months on alectinib and 15.0 on crizotinib, investigator-assessed progression-free survival was significantly longer with alectinib, consistent with the global ALEX result.\n\nALESIA is the reason the 600 mg dose is used across Asia outside Japan, and it is one of the cleanest demonstrations that an ALK result travels between populations, which is not true of every lung cancer finding.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02838420","url":"https://clinicaltrials.gov/study/NCT02838420"},{"label":"ALESIA (Lancet Respiratory Medicine 2019)","url":"https://doi.org/10.1016/S2213-2600(19)30053-0"}],"tags":[],"related":[],"cancers":["alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["alectinib","crizotinib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["brain-metastases","tki-term"],"trials":["alex","profile-1014"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02838420","phase":"3","setting":"Untreated ALK-positive non-small-cell lung cancer in Asian patients: alectinib 600 mg twice daily versus crizotinib 250 mg twice daily, with investigator-assessed progression-free survival as the primary endpoint","sponsor":"Roche","result":"Investigator-assessed progression-free survival significantly longer with alectinib than crizotinib, consistent with the global ALEX trial.","started":"2016-08-03","startedType":"actual","yearReported":2019,"enrolled":187,"enrolledBasis":"registry","outcomes":[],"replication":"Consistent with the global ALEX trial and with the Japanese J-ALEX trial at the lower dose."},{"id":"alex","kind":"trial","name":"ALEX","aka":[],"tldr":"ALEX showed that alectinib, a second-generation ALK drug that gets into the brain, kept ALK-positive lung cancer under control for about three years against less than one with crizotinib, and cut brain progression by three quarters.","summary":"ALEX randomised 303 patients with untreated advanced ALK-positive non-small-cell lung cancer to alectinib or crizotinib. Crizotinib had been the first ALK inhibitor, approved in 2011, but most patients progressed within a year, often in the brain, where the drug penetrates poorly.\n\nAt 12 months the cumulative incidence of brain progression was 9.4 percent with alectinib against 41.4 percent with crizotinib. In the updated analysis median investigator-assessed progression-free survival was 34.8 months against 10.9 months (hazard ratio 0.43), and five-year overall survival was 62.5 percent against 45.5 percent.\n\nThe FDA approved alectinib for first-line use in November 2017; the trial moved a second-generation inhibitor to the front and set the template that CROWN followed with lorlatinib.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02075840","url":"https://clinicaltrials.gov/study/NCT02075840"},{"label":"New England Journal of Medicine 2017","url":"https://doi.org/10.1056/NEJMoa1704795"},{"label":"Annals of Oncology 2020 (five-year survival)","url":"https://doi.org/10.1016/j.annonc.2020.04.478"}],"tags":[],"related":[],"cancers":["nsclc","alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["alectinib","crizotinib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["brain-metastases","tki-term"],"trials":[],"people":["solange-peters","tony-mok","ross-camidge"],"bottlenecks":[],"keyPapers":["paper-peters-alex-alectinib-crizotinib-nejm-2017","paper-alex-ann-oncol-2020-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02075840","phase":"3","setting":"Untreated advanced ALK-positive non-small-cell lung cancer: alectinib versus crizotinib","sponsor":"Roche","result":"Median progression-free survival 34.8 vs 10.9 months (hazard ratio 0.43); 12-month brain progression 9.4% vs 41.4%; 5-year overall survival 62.5% vs 45.5%.","started":"2014-08-19","startedType":"actual","yearReported":2017,"enrolled":303,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (investigator, updated)","primary":true,"unit":"months","arms":[{"name":"Alectinib","n":152,"value":34.8},{"name":"Crizotinib","n":151,"value":10.9}],"hr":0.43,"source":"https://doi.org/10.1016/j.annonc.2020.04.478"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Alectinib","n":152,"value":62.5},{"name":"Crizotinib","n":151,"value":45.5}],"source":"https://doi.org/10.1016/j.annonc.2020.04.478"}],"replication":"The Japanese J-ALEX trial reported the same direction; ALTA-1L (brigatinib) and CROWN (lorlatinib) confirmed that next-generation ALK inhibitors beat crizotinib first line."},{"id":"impassion030","kind":"trial","name":"ALEXANDRA / IMpassion030","aka":["ALEXANDRA","IMpassion030","BIG 16-05","AFT-27"],"tldr":"ALEXANDRA asked whether a year of the immunotherapy atezolizumab added to chemotherapy after surgery stops triple-negative breast cancer coming back. It did not: relapses were no fewer, side effects were more, and the trial was stopped early for futility.","summary":"ALEXANDRA/IMpassion030 (NCT03498716) randomised 2,199 patients undergoing surgery as initial treatment for stage II or III triple-negative breast cancer between August 2018 and November 2022 to 20 weeks of standard adjuvant chemotherapy with (1,101) or without (1,098) atezolizumab for up to one year. The independent data monitoring committee halted enrolment at 2,199 of 2,300 planned patients and all atezolizumab was stopped after a planned interim and futility analysis. At a median follow-up of 32 months invasive disease-free survival events had occurred in 141 patients (12.8 percent) on atezolizumab and 125 (11.4 percent) on chemotherapy alone (stratified hazard ratio 1.11, 95 percent confidence interval 0.87 to 1.42, p 0.38). Grade 3 or 4 treatment-related adverse events were 54 versus 44 percent with similar fatal events (0.8 versus 0.6 percent) and chemotherapy exposure. Published in JAMA in January 2025, it is the clearest negative result for adjuvant-only checkpoint inhibition in this disease, and with GeparDouze and NeoTRIP it ended atezolizumab's early-stage programme.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03498716","url":"https://clinicaltrials.gov/study/NCT03498716"},{"label":"Ignatiadis et al., JAMA 2025: adjuvant atezolizumab for early triple-negative breast cancer, ALEXANDRA/IMpassion030","url":"https://doi.org/10.1001/jama.2024.26886"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["atezolizumab","paclitaxel","doxorubicin","epirubicin","cyclophosphamide"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["efs"],"trials":["gepardouze","a-brave","swog-s1418","keynote-522"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 6): NHS Lothian Western General Hospital Edinburgh, Calderdale and Huddersfield NHS Foundation Trust, Leeds Teaching Hospitals (St James's), the Christie Manchester, Nottingham University Hospitals City Hospital, Royal Stoke University Hospital."],"nct":"NCT03498716","phase":"3","setting":"Stage II to III triple-negative breast cancer treated with surgery first: adjuvant paclitaxel then dose-dense anthracycline and cyclophosphamide with or without atezolizumab for up to one year, 330 centres in 31 countries","sponsor":"Hoffmann-La Roche, with the Breast International Group and Alliance Foundation Trials","result":"iDFS HR 1.11 (0.87 to 1.42), p 0.38; stopped for futility at 2,199 of 2,300 patients.","started":"2018-08-02","startedType":"actual","yearReported":2025,"enrolled":2199,"enrolledBasis":"registry","outcomes":[{"endpoint":"Invasive disease-free survival","primary":true,"arms":[{"name":"Atezolizumab + chemotherapy","n":1101,"note":"141 events (12.8 percent)"},{"name":"Chemotherapy alone","n":1098,"note":"125 events (11.4 percent)"}],"hr":1.11,"ci":[0.87,1.42],"p":"0.38","source":"https://doi.org/10.1001/jama.2024.26886"}],"replication":"Consistent with GeparDouze (neoadjuvant and adjuvant atezolizumab, not significant); A-BRAVE (adjuvant avelumab) showed benefit only in TIL-high tumours in exploratory analysis."},{"id":"alfa-0701","kind":"trial","name":"ALFA-0701","aka":[],"tldr":"ALFA-0701 was the trial that rescued the first ADC: giving gemtuzumab in three small doses with chemotherapy improved event-free survival without the toxicity that got it withdrawn.","summary":"Gemtuzumab 3 mg/m² on days 1, 4, 7. Median EFS 17.3 vs 9.5 months (HR 0.56, 95% CI 0.42-0.76); relapse-free survival improved; OS not significantly different in the final analysis (27.5 vs 21.8 months). Lancet 2012; basis of the 2017 US re-approval. Meta-analysis of five trials confirmed OS benefit in favourable- and intermediate-risk cytogenetics.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00927498","url":"https://clinicaltrials.gov/study/NCT00927498"}],"tags":[],"related":[],"cancers":["aml"],"sections":[],"technologies":["adc"],"targets":["cd33"],"drugs":["gemtuzumab-ozogamicin","cytarabine-7-3"],"companies":["alfa"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00927498","phase":"3","setting":"Newly diagnosed de novo AML, age 50-70: fractionated gemtuzumab ozogamicin added to 7+3 vs 7+3 alone","sponsor":"ALFA group (France)","result":"EFS 17.3 vs 9.5 months; HR 0.56.","started":"2007-12","yearReported":2012,"enrolled":280,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival (median)","primary":true,"unit":"months","arms":[{"name":"GO + 7+3","n":135,"value":17.3},{"name":"7+3","n":136,"value":9.5}],"hr":0.56,"ci":[0.42,0.76],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60485-1/fulltext"},{"endpoint":"Overall survival (median)","unit":"months","arms":[{"name":"GO + 7+3","value":27.5,"note":"Not significant vs control"},{"name":"7+3","value":21.8}],"source":"https://doi.org/10.1016/S0140-6736(12)60485-1"}],"replication":"Hills et al. meta-analysis (Lancet Oncology 2014, 3,325 patients) confirmed reduced relapse and improved OS in favourable/intermediate cytogenetics, none in adverse risk."},{"id":"alina","kind":"trial","name":"ALINA","aka":[],"tldr":"Showed that giving an ALK pill after surgery, instead of chemotherapy, sharply reduces recurrence, including in the brain.","summary":"ALINA, trial NCT03456076 sponsored by Roche and reported in 2023, showed that two years of the ALK inhibitor alectinib after surgery, instead of platinum chemotherapy, sharply reduces recurrence in resected stage IB to IIIA ALK-positive non-small-cell lung cancer, including recurrence in the brain. It enrolled 257 patients, met its primary disease-free survival endpoint in stage II to IIIA disease with a large reduction in the risk of recurrence, also reduced central nervous system recurrence, and led to FDA approval in April 2024. OnCo links it to ALK as a target, to alectinib and to ADAURA, whose adjuvant osimertinib template it follows for a second oncogene. Overall survival data are immature, so whether delaying recurrence translates into more cures is the open question. Alectinib has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT03456076","url":"https://clinicaltrials.gov/study/NCT03456076"}],"tags":[],"related":[],"cancers":["nsclc","alk-positive-nsclc","resectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["alectinib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":["adaura"],"people":[],"bottlenecks":[],"keyPapers":["paper-wu-alina-adjuvant-alectinib-nejm-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03456076","phase":"3","setting":"Adjuvant alectinib 2 years vs platinum chemotherapy after resection of stage IB (≥4 cm)-IIIA ALK-positive NSCLC","sponsor":"Roche","result":"DFS HR 0.24.","started":"2018-08-16","startedType":"actual","yearReported":2023,"enrolled":257,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival, stage II to IIIA","primary":true,"unit":"months","arms":[{"name":"Alectinib","n":116,"note":"Median not reached"},{"name":"Platinum chemotherapy","n":115,"value":44.4}],"hr":0.24,"ci":[0.13,0.45],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2310532"}],"replication":"Mirrors ADAURA (adjuvant osimertinib) for a second oncogene; OS immature."},{"id":"alkove-1","kind":"trial","name":"ALKOVE-1","aka":[],"tldr":"The registrational study of a fourth-generation ALK pill designed to work after lorlatinib and to spare the brain-related side effects.","summary":"ALKOVE-1, trial NCT05384626 sponsored by Nuvalent and reported in 2025, is the registrational phase 1/2 study of neladalkib, a fourth-generation ALK inhibitor designed to work after lorlatinib and to spare the brain-related side effects of earlier drugs. In 253 patients previously treated with ALK inhibitors, the objective response rate by blinded review was 31 percent, with intracranial responses and activity against compound resistance mutations such as G1202R, and the lorlatinib-pretreated pivotal cohort responded more often; a new drug application was submitted in April 2026 with priority review and a PDUFA date of 27 November 2026. OnCo links it to ALK as a target and to neladalkib, and the randomised ALKAZAR trial against alectinib in the first line is recruiting. As a single-arm study it cannot show superiority over existing options, which ALKAZAR will address.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT05384626","url":"https://clinicaltrials.gov/study/NCT05384626"},{"label":"Nuvalent NDA submission","url":"https://investors.nuvalent.com/2026-04-07-Nuvalent-Announces-Submission-of-New-Drug-Application-to-FDA-for-Neladalkib-in-TKI-Pre-treated-Advanced-ALK-positive-NSCLC"}],"tags":[],"related":[],"cancers":["nsclc","alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["neladalkib"],"companies":["nuvalent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05384626","phase":"1/2","setting":"ALK-positive NSCLC after prior ALK TKIs (including lorlatinib): neladalkib single arm","sponsor":"Nuvalent","result":"ORR 31% in heavily pretreated ALK+ NSCLC; NDA under priority review.","started":"2022-06-09","startedType":"actual","yearReported":2025,"enrolled":840,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate, TKI-pretreated ALK+ NSCLC (pivotal cohort)","primary":true,"unit":"%","arms":[{"name":"Neladalkib, lorlatinib-pretreated","value":51}],"source":"https://clinicaltrials.gov/study/NCT05384626"}],"replication":"Single-arm pivotal; ALKAZAR (randomised vs alectinib, first line) is ongoing."},{"id":"nct06956170","kind":"trial","name":"All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myelo","aka":[],"tldr":"A phase 3 trial of Belantamab mafodotin, Pomalidomide, Dexamethasone in multiple myeloma, run by GlaxoSmithKline, active and no longer recruiting.","summary":"All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT06956170 by GlaxoSmithKline, with 21 participants enrolled, started 2022-02-10 and due to reach its primary completion in 2024-05-27. Interventions recorded: Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib. Conditions listed: Multiple Myeloma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06956170","url":"https://clinicaltrials.gov/study/NCT06956170"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["adc","antiemetic-therapy","kinase-inhibitors","protac-degrader"],"targets":[],"drugs":["belantamab-mafodotin","pomalidomide","dexamethasone","bortezomib"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06956170","phase":"3","setting":"A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)","sponsor":"GlaxoSmithKline","started":"2022-02-10","startedType":"actual","yearReported":2025,"enrolled":21,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Belantamab Mafodotin+Pomalidomide+Dexamethasone","n":10,"note":"The median and upper limit of 95% Confidence Interval were not estimable due to an insufficient number of participants with events within the length of follow-…; Figures from the ClinicalTrials.gov results section (first posted 2025-06-11), not from a publication"},{"name":"Bortezomib + Pomalidomide + Dexamethasone","n":11,"value":14.8,"note":"95% CI 1.9 to NA"}],"hr":0.53,"ci":[0.1,2.78],"source":"https://clinicaltrials.gov/study/NCT06956170?tab=results"}]},{"id":"ukallr3","kind":"trial","name":"ALL R3 (UKALLR3)","aka":["UKALLR3","ALLR3","ALL R3","CCLG-ALLR3"],"tldr":"ALL R3 found, to the investigators' surprise, that using mitoxantrone instead of idarubicin in the first block of treatment for children whose leukaemia had relapsed nearly doubled the chance of being alive without progression three years later, and mitoxantrone-based reinduction became the standard.","summary":"ALL R3 was an open-label randomised trial in 22 centres in the United Kingdom and Ireland and nine in Australia and New Zealand for children with a first relapse of acute lymphoblastic leukaemia. Patients were stratified into high-, intermediate- and standard-risk groups by the duration of first remission, site of relapse and immunophenotype, and randomised to idarubicin or mitoxantrone during induction. After three treatment blocks, high-risk patients and intermediate-risk patients with high residual disease went to allogeneic transplant; the rest continued chemotherapy.\n\nOf 239 registered patients, 216 were randomised. Three-year progression-free survival was 64.6 percent with mitoxantrone against 35.9 percent with idarubicin, and three-year overall survival 69.0 against 45.2 percent; the difference came from fewer disease events rather than fewer treatment deaths. The result was unexpected and the randomisation was stopped early. Mitoxantrone-based reinduction became the reference arm of later relapse trials including IntReALL, and the corpus's relapsed childhood leukaemia page names it as the reinduction backbone.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00967057","url":"https://clinicaltrials.gov/study/NCT00967057"}],"tags":["soc-trials"],"related":[],"cancers":["all-paediatric-relapsed","all-leukemia","leukaemia"],"sections":[],"technologies":["cytotoxic-chemotherapy","mrd-testing"],"targets":[],"drugs":["mitoxantrone","idarubicin","dexamethasone","asparaginase","methotrexate"],"companies":["cclg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-all-r3-mitoxantrone-relapsed-childhood-all-parker-lancet-2010"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00967057","phase":"3","setting":"Children aged 1 to 18 with a first relapse of acute lymphoblastic leukaemia in the United Kingdom, Ireland, Australia and New Zealand: reinduction with idarubicin or mitoxantrone alongside dexamethasone, vincristine, asparaginase and methotrexate, with later therapy and transplant decided by risk group and measurable residual disease","sponsor":"Children's Cancer and Leukaemia Group","result":"Three-year progression-free survival 64.6 percent with mitoxantrone against 35.9 percent with idarubicin, and overall survival 69.0 against 45.2 percent; the randomisation was stopped early.","started":"2002-10","yearReported":2010,"enrolled":216,"enrolledBasis":"randomised","enrolledNote":"The registry gives an estimated 470; the Lancet report registered 239 patients between 2003 and 2007 and randomised 216 (212 analysed).","outcomes":[{"endpoint":"Progression-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Mitoxantrone reinduction","n":103,"value":64.6,"note":"95% CI 54.2 to 73.2"},{"name":"Idarubicin reinduction","n":109,"value":35.9,"note":"95% CI 25.9 to 45.9"}],"p":"0.0004","source":"https://doi.org/10.1016/S0140-6736(10)62002-8"},{"endpoint":"Overall survival at 3 years","unit":"%","arms":[{"name":"Mitoxantrone reinduction","n":103,"value":69,"note":"95% CI 58.5 to 77.3"},{"name":"Idarubicin reinduction","n":109,"value":45.2,"note":"95% CI 34.5 to 55.3"}],"p":"0.004","source":"https://doi.org/10.1016/S0140-6736(10)62002-8"},{"endpoint":"Disease events (progression, second relapse, disease-related death), hazard for mitoxantrone against idarubicin","arms":[{"name":"Mitoxantrone reinduction","n":103},{"name":"Idarubicin reinduction","n":109}],"hr":0.56,"ci":[0.34,0.92],"p":"0.007","source":"https://doi.org/10.1016/S0140-6736(10)62002-8"}]},{"id":"nct06636981","kind":"trial","name":"All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi","aka":[],"tldr":"A phase 2 trial of toripalimab in triple-negative breast cancer, run by Fudan University, now recruiting.","summary":"All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi-cohort Phase II Trial is a phase 2, interventional study registered as NCT06636981 by Fudan University, with a registry enrolment figure of 129 participants, started 2024-11-04 and due to reach its primary completion in 2029-09. Interventions recorded: Cohort2: ATRA+Toripalimab+TPC; Cohort1: ATRA+Toripalimab+chemo. Conditions listed: Triple Negative Breast Cancer (TNBC). Triple-negative eligibility wording from the registry: \"Cohort 1: For locally advanced non operable or metastatic TNBC that has not been previously treated, intravenous chemotherapy and anti-tumor therapy may be used during previous neoadjuvant and/or adjuvant therapy stages, provided that the interval between the end of neoadjuvant and/or adjuvant thera\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06636981","url":"https://clinicaltrials.gov/study/NCT06636981"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06636981","phase":"2","setting":"All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi-cohort Phase II Trial","sponsor":"Fudan University","started":"2024-11-04","startedType":"actual","enrolled":129,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01423500","kind":"trial","name":"ALL-SCT BFM International- HSCT in Children and Adolescents With ALL","aka":["ALL-SCT-BFMi"],"tldr":"A phase 3 trial of Fludarabine, Treosulfan and Thiotepa in Leukaemia, run by St. Anna Kinderkrebsforschung, with a status the registry has not verified recently.","summary":"ALL-SCT BFM International- HSCT in Children and Adolescents With ALL is a phase 3 interventional study registered as NCT01423500 by St. Anna Kinderkrebsforschung, with 405 participants planned, started 2007-01 and due to reach its primary completion in 2011-09. Interventions recorded: VP16, TBI, VP16, ATG, TBI, Fludarabine, OKT3, Treosulfan, Thiotepa, VP16, ATG, TBI. Conditions recorded: Lymphoblastic Leukemia, Acute, Childhood;.\n\nLinked to the drug Treosulfan because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01423500","url":"https://clinicaltrials.gov/study/NCT01423500"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["fludarabine","treosulfan","thiotepa"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01423500","phase":"3","setting":"Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia","sponsor":"St. Anna Kinderkrebsforschung","started":"2007-01","enrolled":405,"enrolledBasis":"registry","outcomes":[]},{"id":"alliance-a021501","kind":"trial","name":"Alliance A021501","aka":["A021501"],"tldr":"A021501 set out to test radiotherapy before surgery for borderline pancreatic cancer and closed that arm early because fewer patients reached a clear-margin operation; chemotherapy alone gave 18-month survival of 67 percent and a median of 29.8 months, and became the reference regimen for the setting.","summary":"A021501 registered 126 patients between February 2017 and January 2019: 70 to systemic therapy alone (54 randomised plus 16 after the radiotherapy arm closed) and 56 to chemotherapy followed by hypofractionated radiotherapy. A planned interim analysis mandated closure of any arm in which 11 or fewer of the first 30 patients had an R0 resection: 17 of 30 (57 percent) in the chemotherapy arm and 10 of 30 (33 percent) in the radiotherapy arm, so arm 2 closed. Among evaluable patients the 18-month overall survival rate was 66.7 percent (95 percent confidence interval 56.1 to 79.4) with chemotherapy alone and 47.3 percent (35.8 to 62.5) with chemotherapy and radiotherapy, and median overall survival 29.8 against 17.1 months. The authors concluded that neoadjuvant modified FOLFIRINOX alone is the reference for borderline resectable disease; the trial is the reason NCCN and the corpus's borderline row describe radiotherapy as optional rather than routine.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02839343","url":"https://clinicaltrials.gov/study/NCT02839343"},{"label":"Katz et al., A021501 (JAMA Oncology 2022)","url":"https://doi.org/10.1001/jamaoncol.2022.2319"}],"tags":[],"related":[],"cancers":["pancreatic","borderline-resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","sbrt","hypofractionated-radiotherapy"],"targets":[],"drugs":["folfirinox","folfox"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":["resectability","resection-margins","neoadjuvant-adjuvant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02839343","phase":"2","setting":"Borderline resectable adenocarcinoma of the pancreatic head in the United States and Canada: eight cycles of modified FOLFIRINOX, against seven cycles followed by stereotactic (33 to 40 Gy in five fractions) or hypofractionated image-guided (25 Gy in five fractions) radiotherapy, then surgery and four cycles of FOLFOX, each arm compared with an 18-month survival of 50 percent from history","sponsor":"Alliance for Clinical Trials in Oncology / National Cancer Institute","result":"18-month overall survival 66.7 percent with neoadjuvant modified FOLFIRINOX alone against 47.3 percent with chemotherapy plus hypofractionated radiotherapy; the radiotherapy arm closed at interim analysis (R0 resection 10 of the first 30 against 17 of 30).","started":"2016-12","startedType":"actual","yearReported":2022,"enrolled":126,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 18 months (evaluable patients)","primary":true,"unit":"%","arms":[{"name":"Neoadjuvant mFOLFIRINOX x8","n":70,"value":66.7,"note":"95% CI 56.1 to 79.4; median 29.8 months"},{"name":"mFOLFIRINOX x7 then SBRT or hypofractionated radiotherapy","n":56,"value":47.3,"note":"95% CI 35.8 to 62.5; median 17.1 months; arm closed at interim analysis"}],"source":"https://doi.org/10.1001/jamaoncol.2022.2319"}]},{"id":"alliance-a021806","kind":"trial","name":"Alliance A021806","aka":["A021806","ALLIANCE A021806"],"tldr":"Alliance A021806 is the trial the field is waiting for: 358 people with operable pancreatic cancer randomised to surgery first or chemotherapy first with the same total course of modified FOLFIRINOX. It has finished recruiting; the registry gives December 2028 for the primary completion and no results were published in an indexed journal by September 2026.","summary":"A021806 randomises patients with resectable pancreatic ductal adenocarcinoma (stage I to III by AJCC 8th edition, adenosquamous included) to perioperative modified FOLFIRINOX (eight cycles, resection, four cycles) or adjuvant modified FOLFIRINOX (resection, twelve cycles), the regimen and duration taken from PRODIGE 24; the primary endpoint is overall survival by intention to treat and the design paper (Annals of Surgical Oncology 2024) sets out the resectability criteria, central radiology review and quality-of-life questionnaires that answer the problems seen in SWOG S1505. ClinicalTrials.gov on 24 September 2026 lists the trial as active but no longer recruiting with 358 participants (actual), a start date of 13 October 2020, primary completion on 31 December 2028 and study completion in November 2030, at sites in the United States and Canada only. No primary publication was found in Europe PMC on that date, so the corpus records the design and status without results; together with the Dutch PREOPANC-3 (perioperative against adjuvant FOLFIRINOX, 378 patients, Netherlands and Sweden) it is the phase 3 evidence that will decide whether NICE and other guidelines move neoadjuvant chemotherapy for resectable disease out of trials.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04340141","url":"https://clinicaltrials.gov/study/NCT04340141"},{"label":"Eade et al., ALLIANCE A021806 design (Annals of Surgical Oncology 2024)","url":"https://doi.org/10.1245/s10434-024-15817-5"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["folfirinox"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","resectability","pancreatic-trials-open-today"],"trials":["preopanc-3","swog-s1505","prodige-24"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04340141","phase":"3","setting":"Resectable pancreatic adenocarcinoma in the United States and Canada: eight cycles of modified FOLFIRINOX before surgery and four after, against upfront surgery and twelve adjuvant cycles, with overall survival as the primary endpoint","sponsor":"Alliance for Clinical Trials in Oncology / National Cancer Institute","started":"2020-10-13","startedType":"actual","enrolled":358,"enrolledBasis":"registry","outcomes":[]},{"id":"a071401","kind":"trial","name":"Alliance A071401","aka":["A071401","NCI-2015-00546"],"tldr":"Alliance A071401 showed that a twice-daily tablet blocking the enzyme FAK kept more meningiomas with a faulty NF2 gene from growing at six months than history would predict, in both lower-grade and higher-grade tumours, the first mutation-matched treatment to show activity in this tumour.","summary":"Alliance A071401 (NCT02523014; NCI-2015-00546) is a multicentre, genomically guided phase 2 umbrella trial for progressive or recurrent meningioma that assigns tumours to oral inhibitors by mutation: vismodegib for SMO, capivasertib for AKT1 and PIK3CA, abemaciclib for CDK pathway alterations and the focal adhesion kinase inhibitor GSK2256098 for NF2. Focal adhesion kinase inhibition has a synthetic lethal relationship with NF2 loss, the commonest driver in meningioma. This record covers the NF2 cohort, in which patients received GSK2256098 750 mg orally twice daily until progression. The coprimary endpoints were progression-free survival at six months, judged separately in grade 1 and grade 2 to 3 tumours against historical benchmarks, and response rate by Macdonald criteria; the drug counted as promising if either endpoint met its decision criterion.\n\nOf 322 patients screened for all mutation cohorts, 36 eligible and evaluable patients with NF2 mutations were treated (12 grade 1, 24 grade 2 or 3). Across all grades one patient had a partial response and 24 had stable disease as best response. Six-month progression-free survival was 83 percent in grade 1 (10 of 12; 95 percent CI 52 to 98) and 33 percent in grade 2 or 3 (8 of 24; 16 to 55); both cohorts met the progression-free survival decision criterion. Treatment was well tolerated: seven patients had a grade 3 adverse event at least possibly related to treatment and there were no grade 4 or 5 events (Journal of Clinical Oncology 2023).\n\nThe registry lists the parent umbrella as recruiting, with an estimated enrolment of 124 and an estimated primary completion in January 2027, for the other mutation arms; the National Cancer Institute, GlaxoSmithKline, Genentech and the Brain Science Foundation are collaborators.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02523014","url":"https://clinicaltrials.gov/study/NCT02523014"},{"label":"Journal of Clinical Oncology 2023","url":"https://doi.org/10.1200/JCO.21.02371"}],"tags":[],"related":[],"cancers":["meningioma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["fak"],"drugs":["gsk2256098"],"companies":["gsk","alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-a071401-brastianos-jco-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02523014","phase":"2","setting":"Recurrent or progressive grade 1 to 3 meningioma with a somatic NF2 mutation: oral GSK2256098 750 mg twice daily until progression, as the FAK-inhibitor arm of a genomically guided Alliance phase 2 umbrella","sponsor":"Alliance for Clinical Trials in Oncology","result":"Six-month progression-free survival 83% (10 of 12) in grade 1 and 33% (8 of 24) in grade 2 to 3 NF2-mutant meningioma; both cohorts met the trial's decision criterion for promising activity.","started":"2015-09-28","startedType":"actual","yearReported":2023,"enrolled":36,"enrolledBasis":"analysed","enrolledNote":"The Journal of Clinical Oncology 2023 report analyses 36 eligible and evaluable patients with NF2-mutant meningioma treated with GSK2256098 (12 grade 1, 24 grade 2 or 3) after 322 were screened across all mutation cohorts; ClinicalTrials.gov NCT02523014 lists an estimated enrolment of 124 for the whole umbrella, which is still recruiting to other arms.","outcomes":[{"endpoint":"Progression-free survival at 6 months, grade 1 NF2-mutant meningioma","primary":true,"unit":"%","arms":[{"name":"GSK2256098 750 mg twice daily","n":12,"value":83,"note":"10 of 12; 95% CI 52 to 98"}],"source":"https://doi.org/10.1200/JCO.21.02371"},{"endpoint":"Progression-free survival at 6 months, grade 2 to 3 NF2-mutant meningioma","primary":true,"unit":"%","arms":[{"name":"GSK2256098 750 mg twice daily","n":24,"value":33,"note":"8 of 24; 95% CI 16 to 55"}],"source":"https://doi.org/10.1200/JCO.21.02371"},{"endpoint":"Best response by Macdonald criteria, all grades","primary":true,"unit":"%","arms":[{"name":"GSK2256098 750 mg twice daily","n":36,"value":3,"note":"One partial response among 36 patients (about 3%); 24 had stable disease"}],"source":"https://doi.org/10.1200/JCO.21.02371"}],"replication":"Single-arm cohort judged against historical controls; the other arms of the same umbrella and any confirmatory FAK-inhibitor study in meningioma have not yet reported."},{"id":"n0147","kind":"trial","name":"Alliance N0147","aka":["NCCTG N0147"],"tldr":"The North American version of the same question, with the same answer: cetuximab after surgery adds toxicity and no benefit.","summary":"N0147 randomised patients with resected stage III colon cancer to mFOLFOX6 with or without cetuximab. Three-year disease-free survival was 74.6 percent with chemotherapy alone against 71.5 percent with cetuximab added in KRAS wild-type disease (hazard ratio 1.21, 95% CI 0.98 to 1.49, p=0.08), and 67.1 against 65.0 percent in KRAS-mutant disease. Grade 3 or higher adverse events rose from 52.3 to 72.5 percent. No subgroup benefited. The trial also contributed the mismatch-repair and BRAF cohorts that later defined which stage III tumours are immunologically distinct, the biology that ATOMIC acted on thirteen years later.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00079274","url":"https://clinicaltrials.gov/study/NCT00079274"},{"label":"N0147: oxaliplatin, fluorouracil and leucovorin with or without cetuximab in resected stage III colon cancer (JAMA 2012)","url":"https://doi.org/10.1001/jama.2012.385"}],"tags":[],"related":[],"cancers":["colorectal","colon-cancer"],"sections":[],"technologies":["monoclonal-antibody","cytotoxic-chemotherapy"],"targets":["egfr","kras"],"drugs":["cetuximab","folfox","oxaliplatin","irinotecan"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":["petacc-8","atomic"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00079274","phase":"3","setting":"Resected stage III colon cancer: mFOLFOX6 with or without cetuximab, by KRAS status","sponsor":"National Cancer Institute / Alliance for Clinical Trials in Oncology","result":"Three-year disease-free survival 71.5 with cetuximab against 74.6 percent without, in KRAS wild-type disease.","started":"2004-02","yearReported":2012,"enrolled":3397,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 3 years (KRAS wild-type)","primary":true,"unit":"percent","arms":[{"name":"mFOLFOX6 plus cetuximab","value":71.5},{"name":"mFOLFOX6","value":74.6}],"hr":1.21,"ci":[0.98,1.49],"p":"0.08","source":"https://doi.org/10.1001/jama.2012.385"}]},{"id":"alliance-n0574","kind":"trial","name":"Alliance N0574 (NCCTG N0574)","aka":[],"tldr":"N0574 showed that adding whole-brain radiotherapy to radiosurgery for a few brain metastases damages memory and thinking without lengthening life, and radiosurgery alone became the standard.","summary":"N0574 randomised 213 patients with one to three brain metastases to stereotactic radiosurgery alone or radiosurgery plus whole-brain radiotherapy. Cognitive deterioration at three months, the primary endpoint, occurred in 63.5 percent after radiosurgery alone and 91.7 percent after the combination; whole-brain treatment improved intracranial control but median survival did not differ (10.4 vs 7.4 months, not significant) (Brown and colleagues, JAMA 2016).","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT00377156","url":"https://clinicaltrials.gov/study/NCT00377156"},{"label":"JAMA 2016","url":"https://doi.org/10.1001/jama.2016.9839"}],"tags":["radiation-wave2"],"related":[],"cancers":["brain-tumours","metastatic-cancer","secondary-brain-tumours"],"sections":[],"technologies":["radiosurgery-srs"],"targets":[],"drugs":[],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":["wbrt","stereotactic-radiosurgery"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00377156","phase":"3","setting":"One to three brain metastases: stereotactic radiosurgery alone versus radiosurgery plus whole-brain radiotherapy","sponsor":"Alliance for Clinical Trials in Oncology","result":"Cognitive deterioration at 3 months 63.5% (SRS alone) vs 91.7% (SRS plus WBRT); no survival difference.","started":"2006-07","startedType":"actual","yearReported":2016,"enrolled":213,"enrolledBasis":"registry","outcomes":[{"endpoint":"Cognitive deterioration at 3 months","primary":true,"unit":"%","arms":[{"name":"Radiosurgery alone","n":111,"value":63.5},{"name":"Radiosurgery plus whole-brain radiotherapy","n":102,"value":91.7}]}]},{"id":"calgb-50303","kind":"trial","name":"Alliance/CALGB 50303","aka":["CALGB 50303","Alliance 50303","DA-EPOCH-R versus R-CHOP"],"tldr":"An intensive infusion chemotherapy schedule, widely believed to be better for aggressive lymphoma, was compared head to head with the standard and was not better, only harder to tolerate.","summary":"Dose-adjusted EPOCH-R gives cyclophosphamide, doxorubicin and etoposide as a 96-hour infusion with the dose raised or lowered by the neutrophil count in the previous cycle. Single-arm series had reported excellent results, and many centres had adopted it for higher-risk diffuse large B-cell lymphoma on that basis. CALGB 50303 randomised it against R-CHOP in untreated disease between 2005 and 2013.\n\nAt a median follow-up of five years there was no difference. Progression-free survival gave a hazard ratio of 0.93 (95 per cent confidence interval 0.68 to 1.27, p = 0.65), with two-year rates of 78.9 per cent for dose-adjusted EPOCH-R and 75.5 per cent for R-CHOP; overall survival gave a hazard ratio of 1.09 (0.75 to 1.59, p = 0.64). Grade 3 and 4 adverse events were more common with the infusional regimen, including febrile neutropenia in 35.0 against 17.7 per cent, mucositis in 8.4 against 2.1 per cent and neuropathy in 18.6 against 3.3 per cent. Five treatment-related deaths occurred in each arm.\n\nThe authors' own reading is the honest one: the R-CHOP results were better than historical controls, which suggests the trial selected a favourable population and that the answer may not generalise to the highest-risk subgroups. Dose-adjusted EPOCH-R remains standard in primary mediastinal B-cell lymphoma and in HIV-associated lymphoma, where it was tested separately, and is still used in high-grade B-cell lymphoma with MYC and BCL2 rearrangements on non-randomised evidence.","status":"negative","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT00118209","url":"https://clinicaltrials.gov/study/NCT00118209"},{"label":"Journal of Clinical Oncology 2019","url":"https://doi.org/10.1200/JCO.18.01994"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["dlbcl","non-hodgkin-lymphoma"],"sections":["chemotherapy"],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["rituximab","etoposide","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":[],"institutions":["nci"],"pathways":[],"terms":["r-chop","lymphoma-tx-regimen-alphabet","ipi-score"],"trials":[],"people":[],"bottlenecks":["b-negative-results","b-trial-design","b-toxicity-qol"],"keyPapers":["paper-calgb-50303-da-epoch-r-vs-r-chop-jco-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00118209","phase":"3","setting":"Untreated diffuse large B-cell lymphoma: six cycles of dose-adjusted EPOCH-R against six cycles of R-CHOP","sponsor":"Alliance for Clinical Trials in Oncology","result":"No difference in progression-free survival (hazard ratio 0.93) or overall survival (1.09) against R-CHOP, with substantially more febrile neutropenia, mucositis and neuropathy.","started":"2005-05","startedType":"actual","yearReported":2019,"enrolled":491,"enrolledBasis":"analysed","enrolledNote":"524 patients were registered on the study; 491 were eligible and form the final analysis.","outcomes":[{"endpoint":"Progression-free survival","primary":true,"arms":[{"name":"Dose-adjusted EPOCH-R","note":"two-year rate 78.9 per cent"},{"name":"R-CHOP","note":"two-year rate 75.5 per cent"}],"hr":0.93,"ci":[0.68,1.27],"p":"0.65","source":"https://doi.org/10.1200/JCO.18.01994"},{"endpoint":"Overall survival","arms":[{"name":"Dose-adjusted EPOCH-R","note":"two-year rate 86.5 per cent"},{"name":"R-CHOP","note":"two-year rate 85.7 per cent"}],"hr":1.09,"ci":[0.75,1.59],"p":"0.64"},{"endpoint":"Febrile neutropenia","unit":"%","arms":[{"name":"Dose-adjusted EPOCH-R","value":35},{"name":"R-CHOP","value":17.7}]}],"replication":"The only randomised comparison of the two regimens in unselected diffuse large B-cell lymphoma."},{"id":"rejuv-trial-allocare","kind":"trial","name":"AlloCare: a stepped-care late-effects service after allogeneic transplant","aka":["AlloCare","NCT06281496"],"tldr":"The gap after a transplant is not that nobody knows what should be checked, it is that no mechanism tells an individual survivor what is due. This trial tests an organised four-step late-effects service against usual care.","summary":"The transplant facet of this corpus names the problem this trial attacks: there is a published list of what should be done, an inspected standard for the programmes that should do it, and registries that record outcomes, and there is no mechanism that reliably tells an individual survivor which tests they are due this year.\n\nAlloCare is a two-arm randomised trial of a stepped-care multimodal intervention with four steps: screening for vulnerability, digital health support and education, individual consultations based on patient-reported outcome data using the HM-PRO instrument, and multidisciplinary late-effects management driven by that assessment. The control arm receives usual care. The trial has an internal pilot phase.\n\nThe primary endpoint is the between-group change in the EORTC QLQ-C30 summary score from baseline at three months after transplant to the end of the intervention at twelve months, with follow-up at eighteen months. One hundred participants at a single centre is small, and the result will be a signal about whether an organised service changes quality of life rather than a definitive answer about which components did it. It is included here because trials of the service rather than of an intervention are rare, and because the design is one a health system could copy.\n\nThe registry records no phase for this study, as it tests a service rather than a drug; it is filed here as phase 3 because OnCo's schema has no value for an unphased randomised trial. Registry dates, read on 2 October 2026: start 1 November 2024 (actual), primary completion 1 October 2027 (estimated), completion 1 December 2027 (estimated). Enrolment of 100 is the registry's estimate.","status":"recruiting","asOf":"2026-10-02","links":[{"label":"ClinicalTrials.gov NCT06281496","url":"https://clinicaltrials.gov/study/NCT06281496"}],"tags":["rejuvenation","survivorship","open-problem","transplant","follow-up","services"],"related":["rejuv-tx-long-term-follow-up-frameworks","rejuv-tx-late-effects-overview","rejuv-tx-quality-of-life","rejuv-agenda-nobody-owns-the-follow-up","idea-rejuv-exposure-record-a-machine-can-read","survivorship-care-plan","rejuvenation-roadmap"],"cancers":[],"sections":["rejuvenation","supportive-care"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06281496","phase":"3","setting":"Adults three months after allogeneic haematopoietic stem cell transplantation, single centre, Denmark","sponsor":"Copenhagen University Hospital, Rigshospitalet, with the Danish Cancer Society","started":"2024-11-01","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07551778","kind":"trial","name":"Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of cetuximab and bevacizumab (glioblastoma use) in colorectal cancer, run by BOE Technology Group Co., Ltd., not yet recruiting.","summary":"Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors is a phase 1/2, interventional study registered as NCT07551778 by BOE Technology Group Co., Ltd., with a registry enrolment figure of 42 participants, started 2026-08 and due to reach its primary completion in 2028-04. Interventions recorded: NK Cells; NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy; NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapy; NK cells + PD-(L)1 inhibitor + VEGF inhibitor as first-line maintenance therapy; NK cells + PD-(L)1 inhibitor + capecitabine or S-1 as first-line maintenance therapy. Conditions listed: NSCLC (Advanced Non-small Cell Lung Cancer); Colorectal Cancer; Advanced Solid Tumors; Advanced Hepatocellular Carcinoma (HCC); GC/GEJC. Primary outcome: Dose-Limiting Toxicity (DLT); Adverse Events (AE). Colorectal eligibility wording from the registry: \"* Histologically/cytologically confirmed locally advanced unresectable or metastatic (unresectable Stage III or Stage IV per AJCC 8th Edition) colorectal adenocarcinoma;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07551778","url":"https://clinicaltrials.gov/study/NCT07551778"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["cetuximab","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07551778","phase":"1/2","setting":"An Exploratory Clinical Study to Evaluate the Safety and Efficacy of Allogeneic NK Cell Injection Combined With Standard Maintenance Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors","sponsor":"BOE Technology Group Co., Ltd.","started":"2026-08","startedType":"estimated","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04616209","kind":"trial","name":"Allogeneic PB103 (NK Cells) Therapy in Non-small Cell Lung Cancer (NSCLC) Patients","aka":[],"tldr":"A phase 1/2 trial of donor-derived NK cell infusion in non-small-cell lung cancer, run by Precision Biotech Taiwan Corp., now recruiting.","summary":"Allogeneic PB103 (NK Cells) Therapy in Non-small Cell Lung Cancer (NSCLC) Patients is a phase 1/2 interventional study registered as NCT04616209 by Precision Biotech Taiwan Corp., with 24 participants planned, started 2020-11-15 and due to reach its primary completion in 2027-12-30. Interventions recorded: donor-derived NK cell infusion.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04616209","url":"https://clinicaltrials.gov/study/NCT04616209"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04616209","phase":"1/2","setting":"A Phase Ι & IIa, Open-label Study to Evaluate Safety and Efficacy of the Combination Therapy of Allogeneic PB103 and Standard Cancer Treatment in the IIIB/IV or Recurrent Non-small Cell Lung Cancer (NSCLC) Patients","sponsor":"Precision Biotech Taiwan Corp.","started":"2020-11-15","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"almanac","kind":"trial","name":"ALMANAC (Axillary Lymphatic Mapping Against Nodal Axillary Clearance)","aka":["ALMANAC trial"],"tldr":"The British half of the sentinel node question, and the one that measured what patients actually feel. A year after surgery, arm swelling had fallen from about one woman in eight to one in twenty, and numbness from about one in three to one in nine.","summary":"ALMANAC randomised 1,031 patients with clinically node-negative invasive breast cancer to sentinel lymph node biopsy (515) or to standard axillary treatment (516) between November 1999 and October 2003. Unlike NSABP B-32 it made arm and shoulder morbidity and quality of life the primary outcomes, on the reasoning that the survival question was being answered elsewhere and the morbidity question was the one patients were asking.\n\nAt twelve months the relative risk of any lymphoedema in the sentinel node arm was 0.37 (95 percent confidence interval 0.23 to 0.60), an absolute fall from 13 to 5 percent, and the relative risk of sensory loss was 0.37 (0.27 to 0.50), from 31 to 11 percent. Drain use, length of stay and time to resumption of normal activities were all significantly lower (p<0.001 for each), and axillary operating time fell (p=0.055). Patient-recorded quality of life and arm function were better throughout (p at or below 0.003), with no increase in anxiety.\n\nALMANAC is why the sentinel node case is usually made in terms of harm avoided rather than benefit gained. The cancer outcome is the same; what changes is whether a woman can lift her arm, feel her upper inner arm, and avoid a sleeve for the rest of her life.","status":"positive","asOf":"2026-09-25","links":[{"label":"ALMANAC (Journal of the National Cancer Institute 2006)","url":"https://doi.org/10.1093/jnci/djj158"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["sentinel-node"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["sentinel-lymph-node-biopsy","lymphadenectomy","breast-cancer-related-lymphoedema","axillary-surgery-de-escalation"],"trials":["nsabp-b32"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Operable invasive breast cancer with clinically negative nodes: sentinel node biopsy against standard axillary treatment, with arm and shoulder morbidity and quality of life as the primary outcomes","sponsor":"Cardiff University and the United Kingdom ALMANAC Trialists Group","result":"At twelve months, lymphoedema 5 against 13 percent (relative risk 0.37) and sensory loss 11 against 31 percent (relative risk 0.37) after sentinel node biopsy against standard axillary treatment.","yearReported":2006,"enrolled":1031,"enrolledBasis":"randomised","enrolledNote":"1,031 patients were randomised between November 1999 and October 2003; the trial predates United Kingdom registration requirements and carries no registry id.","outcomes":[{"endpoint":"Any lymphoedema at 12 months","primary":true,"unit":"%","arms":[{"name":"Sentinel lymph node biopsy","n":515,"value":5},{"name":"Standard axillary treatment","n":516,"value":13}],"source":"https://doi.org/10.1093/jnci/djj158"},{"endpoint":"Sensory loss at 12 months","primary":true,"unit":"%","arms":[{"name":"Sentinel lymph node biopsy","n":515,"value":11},{"name":"Standard axillary treatment","n":516,"value":31}],"source":"https://doi.org/10.1093/jnci/djj158"}],"replication":"NSABP B-32 established the survival equivalence in 5,611 women; IBCSG 23-01 and AMAROS later measured the same morbidity gap when clearance was avoided in node-positive disease."},{"id":"nct06043973","kind":"trial","name":"Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance","aka":[],"tldr":"A phase 3 trial of aumolertinib in lung cancer, run by Qianfoshan Hospital, now recruiting.","summary":"Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance is a phase 3, interventional study registered as NCT06043973 by Qianfoshan Hospital, with a registry enrolment figure of 98 participants, started 2023-09-01 and due to reach its primary completion in 2026-09-01. Interventions recorded: almonertinib. Conditions listed: Advanced Non-small Cell Lung Cancer. Primary outcome: PFS. Lung eligibility wording from the registry: \"Metastatic Non-squamous NSCLC is histologically or cytologically proven to be inoperable and cannot receive radical concurrent chemoradiotherapy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06043973","url":"https://clinicaltrials.gov/study/NCT06043973"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["aumolertinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06043973","phase":"3","setting":"A Prospective Single-center, Single-arm Clinical Study of Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation and TP53 Mutation","sponsor":"Qianfoshan Hospital","started":"2023-09-01","startedType":"actual","enrolled":98,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04687241","kind":"trial","name":"Almonertinib Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With EGFR-sensitive Mutations","aka":[],"tldr":"A phase 3 trial of Aumolertinib in non-small-cell lung cancer and small-cell lung cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"Almonertinib Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With EGFR-sensitive Mutations is a phase 3 interventional study registered as NCT04687241 by Jiangsu Hansoh Pharmaceutical Co., Ltd., with 192 participants planned, started 2021-04-30 and due to reach its primary completion in 2024-07-08. Interventions recorded: Almonertinib, Placebo Almonertinib. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04687241","url":"https://clinicaltrials.gov/study/NCT04687241"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["aumolertinib"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04687241-lancet-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04687241","phase":"3","setting":"Efficacy and Safety of Almonertinib Versus Placebo as Adjuvant Therapy for Subjects With Resected Stage II-IIIB NSCLC Harboring EGFR-sensitive Mutations: A Randomized, Controlled, Double-blind, Phase 3 and Multicenter Clinical Study","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","started":"2021-04-30","startedType":"actual","enrolled":192,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05948943","kind":"trial","name":"Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.","aka":["EPIK-L1"],"tldr":"A phase 2/3 trial of Alpelisib in childhood cancers, run by Novartis Pharmaceuticals, now recruiting.","summary":"Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation. is a phase 2/3 interventional study registered as NCT05948943 by Novartis Pharmaceuticals, with 232 participants planned, started 2023-11-24 and due to reach its primary completion in 2028-05-31. Interventions recorded: Alpelisib and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05948943","url":"https://clinicaltrials.gov/study/NCT05948943"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["childhood-cancers"],"sections":[],"technologies":["kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["alpelisib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05948943","phase":"2/3","setting":"A Two-stage Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.","sponsor":"Novartis Pharmaceuticals","started":"2023-11-24","startedType":"actual","enrolled":232,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05660083","kind":"trial","name":"Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by The Methodist Hospital Research Institute, now recruiting.","summary":"Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC) is a phase 2, interventional study registered as NCT05660083 by The Methodist Hospital Research Institute, with a registry enrolment figure of 36 participants, started 2023-01-12 and due to reach its primary completion in 2026-12-01. Interventions recorded: L-NMMA. Conditions listed: HER2-negative Breast Cancer; Metastatic Breast Cancer; Metaplastic Breast Carcinoma; TNBC - Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Histologically confirmed HER2 negative MpBC and/or Triple Negative Breast Cancer (TNBC) with squamous and/or sarcomatoid elements, including osseous, chondroid, and spindle morphology\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05660083","url":"https://clinicaltrials.gov/study/NCT05660083"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05660083","phase":"2","setting":"Phase II Trial of Alpelisib With iNOS Inhibitor and Nab-paclitaxel in Patients With HER2 Negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC)","sponsor":"The Methodist Hospital Research Institute","started":"2023-01-12","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"alphabreak","kind":"trial","name":"AlphaBreak (FPI-2265) & AcTION (225Ac-PSMA-617)","aka":[],"tldr":"The phase 3 trials that will decide whether alpha-emitting PSMA drugs become the next step after Pluvicto.","summary":"AlphaBreak and AcTION, led by trial NCT06402331, are the phase 3 trials that will decide whether alpha-emitting PSMA drugs become the next step after Pluvicto in PSMA-positive metastatic castration-resistant prostate cancer. AlphaBreak tests FPI-2265, an actinium-225 PSMA-I&T agent from AstraZeneca and Fusion, after lutetium PSMA therapy, while Novartis' AcTION programme tests actinium-225 PSMA-617 in post-lutetium and lutetium-naive settings, and Bayer's PAnTHA phase 1 of 225Ac-PSMA-Trillium reported at ASCO GU 2026; the record lists an enrolment target of 600. OnCo links them to targeted alpha therapy, the actinium-225 PSMA agents record, and to Fusion, AstraZeneca, Novartis and Bayer. Both are recruiting with no results, dry mouth and actinium-225 supply are the constraints, and whether alpha emitters help after lutetium is the question they exist to answer.","status":"active","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT06402331","url":"https://clinicaltrials.gov/study/NCT06402331"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["targeted-alpha-therapy"],"targets":[],"drugs":["ac225-psma"],"companies":["fusion-pharma","astrazeneca","novartis","bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06402331","phase":"2","setting":"PSMA-positive mCRPC: actinium-225 PSMA radioligands vs standard of care, including after 177Lu-PSMA","sponsor":"AstraZeneca (Fusion); Novartis","started":"2024-03-05","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing phase 3 of 225Ac-PSMA-I&T after 177Lu-PSMA; no results."},{"id":"alphamedix-02","kind":"trial","name":"ALPHAMEDIX-02","aka":[],"tldr":"An alpha-emitting radioligand met all its primary endpoints, with responses in more than half of patients new to radioligand therapy.","summary":"ALPHAMEDIX-02, trial NCT05153772 sponsored by RadioMedix, Orano Med and Sanofi and reported in 2025, showed that the alpha-emitting radioligand 212Pb-DOTAMTATE met all its primary endpoints, with responses in more than half of patients with somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumours who were new to radioligand therapy. In the single-arm phase 2 the objective response rate in PRRT-naive patients was 54.3 percent, most were still progression-free around three years, and the PRRT-exposed cohort was largely progression-free at eighteen months, as Sanofi reported in October 2025; the drug holds Breakthrough Therapy designation and the registrational path is being finalised. OnCo links it to targeted alpha therapy, PRRT, 212Pb-DOTAMTATE and the pairing of beta then alpha PRRT. Whether a randomised trial confirms superiority over lutetium is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05153772","url":"https://clinicaltrials.gov/study/NCT05153772"},{"label":"Sanofi press release","url":"https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-08-05-00-00-3163053"}],"tags":[],"related":[],"cancers":["neuroendocrine"],"sections":[],"technologies":["targeted-alpha-therapy","prrt"],"targets":[],"drugs":["alphamedix"],"companies":["radiomedix","orano-med","sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05153772","phase":"2","setting":"Unresectable or metastatic SSTR-positive GEP-NETs, PRRT-naive and PRRT-exposed cohorts: 212Pb-DOTAMTATE single arm","sponsor":"RadioMedix / Orano Med / Sanofi","result":"ORR 54.3% (PRRT-naive); all primary endpoints met.","started":"2021-12-21","startedType":"actual","yearReported":2025,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (PRRT-naive)","primary":true,"unit":"%","arms":[{"name":"212Pb-DOTAMTATE","value":54.3}],"source":"https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-08-05-00-00-3163053"}]},{"id":"alpine","kind":"trial","name":"ALPINE","aka":[],"tldr":"The first head-to-head trial in which a newer BTK inhibitor was both safer and more effective than ibrutinib.","summary":"ALPINE, trial NCT03734016 sponsored by BeOne, formerly BeiGene, and published in the New England Journal of Medicine in 2023, was the first head-to-head trial in which a newer BTK inhibitor was both safer and more effective than ibrutinib in relapsed or refractory chronic lymphocytic leukaemia. It randomised 652 patients to zanubrutinib or ibrutinib, met its primary progression-free survival endpoint including in del(17p) and TP53 disease, produced a higher response rate, less than half the rate of atrial fibrillation and fewer discontinuations, and the three-year update maintained the advantage. OnCo links it to chronic lymphocytic leukaemia, BTK as a target, zanubrutinib, ibrutinib, John Oyler, Jennifer R. Brown and the caution pairing about ibrutinib in patients with cardiac risk. Whether that superiority reflects the drug or the trial is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03734016","url":"https://clinicaltrials.gov/study/NCT03734016"}],"tags":[],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["btk"],"drugs":["zanubrutinib","ibrutinib"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["oyler-john","jennifer-brown"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03734016","phase":"3","setting":"Relapsed or refractory CLL/SLL: zanubrutinib vs ibrutinib","sponsor":"BeOne (BeiGene)","result":"PFS HR 0.65; AF 5.2% vs 13.3%.","started":"2018-11-01","startedType":"actual","yearReported":2022,"enrolled":652,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"arms":[{"name":"Zanubrutinib","n":327},{"name":"Ibrutinib","n":325}],"hr":0.65,"ci":[0.49,0.86],"p":"0.002","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2211582"},{"endpoint":"Overall response rate","unit":"%","arms":[{"name":"Zanubrutinib","value":86.2},{"name":"Ibrutinib","value":75.7}],"source":"https://doi.org/10.1056/NEJMoa2211582"},{"endpoint":"Atrial fibrillation/flutter","unit":"%","arms":[{"name":"Zanubrutinib","value":5.2},{"name":"Ibrutinib","value":13.3}],"source":"https://doi.org/10.1056/NEJMoa2211582"}],"replication":"ELEVATE-RR (acalabrutinib vs ibrutinib) showed non-inferior PFS with less atrial fibrillation; ALPINE is the only trial to show PFS superiority."},{"id":"alsympca","kind":"trial","name":"ALSYMPCA","aka":[],"tldr":"ALSYMPCA is the trial that won approval for the first alpha-emitting drug.","summary":"ALSYMPCA, trial NCT00699751 sponsored by Bayer and Algeta and reported in 2013, is the trial that won approval for radium-223, the first alpha-emitting drug. It randomised 921 men with symptomatic bone-metastatic castration-resistant prostate cancer and no visceral disease to radium-223 or placebo, met its primary overall survival endpoint and reduced skeletal events. OnCo links it to prostate cancer, targeted alpha therapy, radium-223 dichloride, A. Oliver Sartor and Karim Fizazi; it was a single pivotal trial, and the later ERA 223 combination with abiraterone was harmful, so use is now restricted to monotherapy in bone-predominant disease. Whether targeted alpha emitters such as actinium-225 PSMA agents can go further than a bone-seeking radium ever could is the question its legacy poses. Radium-223 has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT00699751","url":"https://clinicaltrials.gov/study/NCT00699751"},{"label":"NICE TA412: radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases","url":"https://www.nice.org.uk/guidance/ta412"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["targeted-alpha-therapy"],"targets":[],"drugs":["radium-223"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":["prostate-crpc-sequencing","prostate-uk-drug-approvals"],"trials":["era-223","peace-3"],"people":["oliver-sartor","karim-fizazi"],"bottlenecks":[],"keyPapers":["paper-alsympca-radium-223-nejm-2013"],"journals":[],"dependsOn":[],"notes":["In England NICE TA412 recommends radium-223 dichloride for hormone-relapsed prostate cancer with symptomatic bone metastases and no known visceral metastases, only if the man has already had docetaxel or docetaxel is contraindicated or unsuitable, and only with the patient access scheme discount. Two subsequent trials define how it should be combined: ERA 223 found that adding it to abiraterone without mandatory bone protection produced fractures in 29 against 11 percent and no benefit, while PEACE-3, with enzalutamide and with bone-protecting agents mandatory for everyone from March 2018, found median overall survival 38.2 against 32.6 months (hazard ratio 0.76, 95 percent confidence interval 0.60 to 0.96)."],"nct":"NCT00699751","phase":"3","setting":"Symptomatic bone-metastatic CRPC without visceral disease: radium-223 vs placebo","sponsor":"Bayer / Algeta","result":"OS HR 0.70.","started":"2008-06-12","startedType":"actual","yearReported":2013,"enrolled":921,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Radium-223","n":614,"value":14.9},{"name":"Placebo","n":307,"value":11.3}],"hr":0.7,"ci":[0.58,0.83],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1213755"}],"replication":"Single pivotal trial; the ERA 223 combination with abiraterone was harmful, so use is now restricted to monotherapy in bone-predominant disease."},{"id":"alta","kind":"trial","name":"ALTA","aka":["ALK in Lung Cancer Trial of AP26113","AP26113-13-201"],"tldr":"ALTA tested two doses of brigatinib in ALK-positive lung cancer that had progressed on crizotinib; the higher dose, started after a lower-dose first week, gave more responses and longer control, including in the brain.","summary":"ALTA (ALK in Lung Cancer Trial of AP26113) was a randomised phase 2 trial of brigatinib in ALK-positive non-small-cell lung cancer that had progressed on crizotinib. It randomised 222 patients 1:1 to brigatinib 90 mg once daily (arm A, 112 patients, 109 treated) or 180 mg once daily after a 7-day lead-in at 90 mg (arm B, 110 patients), stratified by brain metastases and best response to crizotinib. At baseline 69 percent had brain metastases and 74 percent had received chemotherapy. The primary endpoint was investigator-assessed confirmed objective response rate; there was no arm without brigatinib.\n\nAt a median follow-up of 8.0 months the confirmed response rate was 45 percent in arm A and 54 percent in arm B, and median progression-free survival was 9.2 and 12.9 months. Among patients with measurable brain metastases, independent review found intracranial responses in 11 of 26 (42 percent) and 12 of 18 (67 percent). Common adverse events were nausea, diarrhoea, headache and cough, mostly grade 1 or 2. A subset of pulmonary adverse events with early onset (median day 2) occurred in 14 of 219 treated patients (grade 3 or higher in 3 percent) and none occurred after escalation to 180 mg in arm B (Journal of Clinical Oncology 2017).\n\nThe authors concluded that 180 mg with the lead-in was consistently more effective than 90 mg with acceptable safety. The trial supported the 2017 US approval of brigatinib after crizotinib; ALTA-1L then tested it against crizotinib in untreated disease.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02094573","url":"https://clinicaltrials.gov/study/NCT02094573"},{"label":"Journal of Clinical Oncology 2017","url":"https://doi.org/10.1200/JCO.2016.71.5904"},{"label":"Journal of Clinical Oncology 2018 (brain metastases, exploratory)","url":"https://doi.org/10.1200/JCO.2017.77.5841"}],"tags":[],"related":["alta-1l"],"cancers":["nsclc","alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["brigatinib"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":["brain-metastases"],"trials":[],"people":["kim-dong-wan","ross-camidge"],"bottlenecks":[],"keyPapers":["paper-alta-jco-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02094573","phase":"2","setting":"ALK-positive advanced non-small-cell lung cancer that progressed on crizotinib: two brigatinib dose regimens, randomised, no control arm","sponsor":"Ariad Pharmaceuticals","result":"Confirmed objective response rate 45% (90 mg) and 54% (180 mg after a 7-day 90 mg lead-in); median progression-free survival 9.2 and 12.9 months (investigator-assessed, 8.0-month median follow-up).","started":"2014-06-04","startedType":"actual","yearReported":2017,"enrolled":222,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed objective response rate (investigator)","primary":true,"unit":"%","arms":[{"name":"Brigatinib 90 mg","n":112,"value":45,"note":"97.5% CI 34 to 56; 112 randomised, 109 treated"},{"name":"Brigatinib 180 mg (7-day 90 mg lead-in)","n":110,"value":54,"note":"97.5% CI 43 to 65"}],"source":"https://doi.org/10.1200/JCO.2016.71.5904"},{"endpoint":"Progression-free survival (investigator)","unit":"months","arms":[{"name":"Brigatinib 90 mg","n":112,"value":9.2},{"name":"Brigatinib 180 mg (7-day 90 mg lead-in)","n":110,"value":12.9}],"source":"https://doi.org/10.1200/JCO.2016.71.5904"},{"endpoint":"Intracranial objective response rate (independent review, measurable brain metastases)","unit":"%","arms":[{"name":"Brigatinib 90 mg","n":26,"value":42,"note":"11 of 26"},{"name":"Brigatinib 180 mg (7-day 90 mg lead-in)","n":18,"value":67,"note":"12 of 18"}],"source":"https://doi.org/10.1200/JCO.2016.71.5904"}]},{"id":"alta-1l","kind":"trial","name":"ALTA-1L","aka":[],"tldr":"ALTA-1L showed that brigatinib more than doubled the time ALK-positive lung cancer stayed under control compared with crizotinib, with strong activity against brain metastases.","summary":"ALTA-1L randomised 275 patients with untreated advanced ALK-positive non-small-cell lung cancer to brigatinib or crizotinib, allowing up to one prior line of chemotherapy. Brigatinib had been approved in 2017 for patients who had progressed on crizotinib.\n\nIn the final analysis median progression-free survival by blinded independent review was 24.0 months with brigatinib against 11.1 months with crizotinib (hazard ratio 0.48); among patients with brain metastases at baseline the intracranial response rate was much higher with brigatinib. Early pulmonary events in the first week, seen in a small minority, are the drug's distinctive toxicity and are managed by a lower starting dose.\n\nThe FDA approved brigatinib for first-line use in May 2020, giving a third first-line option alongside alectinib and lorlatinib.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02737501","url":"https://clinicaltrials.gov/study/NCT02737501"},{"label":"New England Journal of Medicine 2018","url":"https://doi.org/10.1056/NEJMoa1810171"},{"label":"Journal of Thoracic Oncology 2021 (final analysis)","url":"https://doi.org/10.1016/j.jtho.2021.07.035"}],"tags":[],"related":[],"cancers":["nsclc","alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["brigatinib","crizotinib"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":["brain-metastases"],"trials":[],"people":["ross-camidge"],"bottlenecks":[],"keyPapers":["paper-camidge-j-thorac-oncol","paper-alta-1l-n-engl-j-med-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02737501","phase":"3","setting":"Untreated advanced ALK-positive non-small-cell lung cancer: brigatinib versus crizotinib","sponsor":"Takeda (ARIAD)","result":"Median progression-free survival 24.0 vs 11.1 months (hazard ratio 0.48, blinded independent review, final analysis).","started":"2016-05-26","startedType":"actual","yearReported":2018,"enrolled":275,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (blinded independent review, final)","primary":true,"unit":"months","arms":[{"name":"Brigatinib","n":137,"value":24},{"name":"Crizotinib","n":138,"value":11.1}],"hr":0.48,"source":"https://doi.org/10.1016/j.jtho.2021.07.035"}],"replication":"Consistent with ALEX and CROWN; brigatinib is one of three next-generation inhibitors recommended first line."},{"id":"altair","kind":"trial","name":"ALTAIR","aka":[],"tldr":"Treating the blood test result before the cancer shows up on a scan did not work. It delayed relapse by about four months and caused severe blood toxicity in three-quarters of patients.","summary":"ALTAIR was the double-blind randomised phase 3 trial embedded in the CIRCULATE-Japan platform. Patients with resected colorectal cancer who became ctDNA-positive after completing standard-of-care therapy, with no radiological evidence of disease, were randomised 1:1 to trifluridine/tipiracil or placebo for six months. Between July 2020 and June 2023, 243 patients were randomised (122 to the drug, 121 to placebo). Median disease-free survival was 9.30 against 5.55 months (hazard ratio 0.79, 95% CI 0.60 to 1.05, p=0.107) and the primary endpoint was not met. Grade 3 or higher haematological adverse events occurred in 73.0 against 3.3 percent. The conclusion is that late-line chemotherapy started at molecular recurrence does not clear minimal residual disease, and that a better drug, not earlier timing, is what ctDNA-positive patients need.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04457297","url":"https://clinicaltrials.gov/study/NCT04457297"},{"label":"ALTAIR: post-adjuvant chemotherapy in ctDNA-positive patients with resected colorectal cancer (Nature Medicine 2026)","url":"https://doi.org/10.1038/s41591-026-04428-0"},{"label":"CIRCULATE-Japan: ctDNA-guided adaptive platform trials (Cancer Science 2021)","url":"https://doi.org/10.1111/cas.14926"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["mrd-testing","liquid-biopsy"],"targets":[],"drugs":["trifluridine-tipiracil","signatera"],"companies":[],"institutions":["ncc-japan"],"pathways":[],"terms":["mrd","ctdna"],"trials":["circulate-japan","dynamic-iii"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04457297","phase":"3","setting":"Resected stage 0 to IV colorectal cancer that became ctDNA-positive after standard treatment, with no disease visible on scans: six months of trifluridine/tipiracil against placebo","sponsor":"National Cancer Center Hospital East","result":"Median disease-free survival 9.30 against 5.55 months (hazard ratio 0.79, p=0.107): primary endpoint not met.","started":"2020-07-08","startedType":"actual","yearReported":2026,"enrolled":243,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival","primary":true,"unit":"months","arms":[{"name":"Trifluridine/tipiracil","n":122,"value":9.3},{"name":"Placebo","n":121,"value":5.55}],"hr":0.79,"ci":[0.6,1.05],"p":"0.107","source":"https://doi.org/10.1038/s41591-026-04428-0"}],"replication":"DYNAMIC-III reached the same conclusion for escalation in ctDNA-positive stage III disease."},{"id":"alter-0303","kind":"trial","name":"ALTER 0303","aka":[],"tldr":"The trial that showed anlotinib helps patients with lung cancer live longer after other treatments have failed, the basis of one of China's most used cancer pills.","summary":"439 patients randomised 2:1. Median overall survival 9.6 versus 6.3 months (hazard ratio 0.68) and progression-free survival 5.4 versus 1.4 months; published in JAMA Oncology 2018. NMPA approval May 2018. Anlotinib went on to approvals in sarcoma, small cell lung cancer and thyroid cancer and to dozens of combination trials with domestic PD-1 antibodies.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT02388919","url":"https://clinicaltrials.gov/study/NCT02388919"},{"label":"JAMA Oncol 2018","url":"https://doi.org/10.1001/jamaoncol.2018.3039"}],"tags":["china"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["kinase-inhibitors","antiangiogenic"],"targets":[],"drugs":["anlotinib"],"companies":["sino-biopharm"],"institutions":["shanghai-chest-hospital"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-alter-0303-jama-oncol-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02388919","phase":"2/3","setting":"Advanced NSCLC after at least two lines of therapy, China: anlotinib vs placebo","sponsor":"Chia Tai Tianqing (Sino Biopharm)","result":"OS 9.6 vs 6.3 months, HR 0.68.","started":"2015-02-26","startedType":"actual","yearReported":2018,"enrolled":439,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Anlotinib","n":294,"value":9.6},{"name":"Placebo","n":145,"value":6.3}],"hr":0.68,"source":"https://doi.org/10.1001/jamaoncol.2018.3039"}]},{"id":"nct07780838","kind":"trial","name":"Alternating Chemo-immunotherapy and FGFR Inhibitor for FGFR-positive Biliary or Cholangiocarcinoma","aka":[],"tldr":"A phase 2 trial of durvalumab, gemcitabine, cisplatin and pemigatinib in gallbladder cancer and other biliary tract cancers, run by Ohio State University Comprehensive Cancer Center, now recruiting.","summary":"Alternating Chemo-immunotherapy and FGFR Inhibitor for FGFR-positive Biliary or Cholangiocarcinoma is a phase 2 interventional study registered as NCT07780838 by Ohio State University Comprehensive Cancer Center, with a registry enrolment figure of 29 participants, started 2026-11-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: Biospecimen Collection, Cisplatin, Computed Tomography, Durvalumab, Gemcitabine, Magnetic Resonance Imaging, Pemigatinib, Survey Administration. Conditions listed: Locally Advanced Ampulla of Vater Carcinoma, Locally Advanced Biliary Tract Carcinoma, Locally Advanced Extrahepatic Cholangiocarcinoma, Locally Advanced Gallbladder Carcinoma, Locally Advanced Intrahepatic Cholangiocarcinoma, Metastatic Ampulla of Vater Carcinoma, Metastatic Biliary Tract Carcinoma, Metastatic Extrahepatic Cholangiocarcinoma, Metastatic Gallbladder Carcinoma, Metastatic Intrahepatic Cholangiocarcinoma, Stage III Ampulla of Vater Cancer AJCC v8, Stage III Distal Bile Duct Cancer AJCC v8, Stage III Gallbladder Cancer AJCC v8, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Ampulla of Vater Cancer AJCC v8, Stage IV Distal Bile Duct Cancer AJCC v8, Stage IV Gallbladder Cancer AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Unresectable Ampulla of Vater Carcinoma, Unresectable Biliary Tract Carcinoma, Unresectable Extrahepatic Cholangiocarcinoma, Unresectable Gallbladder Carcinoma, Unresectable Intrahepatic Cholangiocarcinoma. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07780838","url":"https://clinicaltrials.gov/study/NCT07780838"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","kinase-inhibitors"],"targets":[],"drugs":["durvalumab","gemcitabine","cisplatin","pemigatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07780838","phase":"2","setting":"A Phase IIa Clinical Trial of First-Line Cyclical Gemcitabine, Cisplatin, and Durvalumab Alternating With Pemigatinib for Advanced Biliary Tract Cancers With FGFR2 Alterations","sponsor":"Ohio State University Comprehensive Cancer Center","started":"2026-11-01","startedType":"estimated","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07569679","kind":"trial","name":"Alternating HAIC and Systemic Chemotherapy With or Without Adebrelimab and Apatinib for Unresectable Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of adebrelimab, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by Air Force Military Medical University, China, now recruiting.","summary":"Alternating HAIC and Systemic Chemotherapy With or Without Adebrelimab and Apatinib for Unresectable Biliary Tract Cancer is a phase 2 interventional study registered as NCT07569679 by Air Force Military Medical University, China, with a registry enrolment figure of 124 participants, started 2025-12-10 and due to reach its primary completion in 2028-12-30. Interventions recorded: HAIC, Gemcitabine plus Cisplatin, Adebrelimab, Apatinib. Conditions listed: Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: \"2. Histologically or cytologically confirmed diagnosis unresectable, locally advanced, or metastatic BTC, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07569679","url":"https://clinicaltrials.gov/study/NCT07569679"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["adebrelimab","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07569679","phase":"2","setting":"A Prospective, Real-World Study of Alternating Hepatic Arterial Infusion Chemotherapy and Systemic Chemotherapy With or Without Adebrelimab and Apatinib in Patients With Unresectable Biliary Tract Cancer","sponsor":"Air Force Military Medical University, China","started":"2025-12-10","startedType":"actual","enrolled":124,"enrolledBasis":"registry","outcomes":[]},{"id":"amaros","kind":"trial","name":"AMAROS (EORTC 10981-22023)","aka":["EORTC 10981-22023","After Mapping of the Axilla: Radiotherapy Or Surgery"],"tldr":"AMAROS asked whether radiotherapy could replace surgery in an armpit known to contain cancer. It can: the cancer came back in the armpit in about one woman in a hundred either way, but arm swelling was half as common after radiotherapy.","summary":"AMAROS screened 4,806 patients with clinical T1 or T2 node-negative breast cancer by sentinel node biopsy and randomised the 1,425 who proved node-positive to axillary clearance (744) or axillary radiotherapy (681). The pre-planned ten-year analysis reported in 2023.\n\nBy intention to treat, the ten-year cumulative incidence of axillary recurrence was 0.93 percent after clearance (seven events) and 1.82 percent after radiotherapy (eleven events), a hazard ratio of 1.71 (95 percent confidence interval 0.67 to 4.39): both figures are very low, and the confidence interval is wide because the events are so few. There was no difference in overall survival (hazard ratio 1.17, 0.89 to 1.52) or disease-free survival (1.19, 0.97 to 1.46).\n\nThe reason to prefer radiotherapy is the arm. In the updated five-year analysis, lymphoedema occurred in 24.5 percent after clearance and 11.9 percent after radiotherapy (p<0.001), while quality-of-life scales did not differ. One finding cuts the other way and is reported as exploratory: the ten-year cumulative incidence of second primary cancers was 12.1 percent after radiotherapy and 8.3 percent after clearance.\n\nThe trial's own conclusion is that axillary radiotherapy is preferred over clearance for a patient with a positive sentinel node and T1 or T2 disease. In England, NICE NG101 recommendation 1.4.12 offers either.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00014612","url":"https://clinicaltrials.gov/study/NCT00014612"},{"label":"AMAROS ten-year results (Journal of Clinical Oncology 2023)","url":"https://doi.org/10.1200/JCO.22.01565"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["sentinel-node","imrt-igrt"],"targets":[],"drugs":[],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["sentinel-lymph-node-biopsy","lymphadenectomy","breast-cancer-related-lymphoedema","axillary-surgery-de-escalation"],"trials":["acosog-z0011","senomac","posnoc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00014612","phase":"3","setting":"Clinical T1 or T2 node-negative breast cancer with a positive sentinel node: axillary clearance against axillary radiotherapy, with the axillary recurrence rate as the endpoint and a non-inferiority design","sponsor":"European Organisation for Research and Treatment of Cancer","result":"Ten-year axillary recurrence 1.82 percent after radiotherapy against 0.93 percent after clearance, with no difference in survival and lymphoedema halved (11.9 against 24.5 percent at five years).","started":"2001-02","yearReported":2023,"enrolled":1425,"enrolledBasis":"randomised","enrolledNote":"4,806 patients underwent sentinel node biopsy and the 1,425 found to be node-positive were randomised; the ClinicalTrials.gov record NCT00014612 gives the registered total of 4,813.","outcomes":[{"endpoint":"Cumulative incidence of axillary recurrence at 10 years","primary":true,"unit":"%","arms":[{"name":"Axillary radiotherapy","n":681,"value":1.82,"note":"eleven events, 95 percent confidence interval 0.74 to 2.94"},{"name":"Axillary lymph node dissection","n":744,"value":0.93,"note":"seven events, 95 percent confidence interval 0.18 to 1.68"}],"hr":1.71,"ci":[0.67,4.39],"source":"https://doi.org/10.1200/JCO.22.01565"},{"endpoint":"Lymphoedema at 5 years","unit":"%","arms":[{"name":"Axillary radiotherapy","n":681,"value":11.9},{"name":"Axillary lymph node dissection","n":744,"value":24.5}],"p":"<0.001","source":"https://doi.org/10.1200/JCO.22.01565"},{"endpoint":"Second primary cancers at 10 years (exploratory)","unit":"%","arms":[{"name":"Axillary radiotherapy","n":681,"value":12.1},{"name":"Axillary lymph node dissection","n":744,"value":8.3}],"source":"https://doi.org/10.1200/JCO.22.01565"}],"replication":"Z0011 and SENOMAC showed that in much of this population neither treatment is needed; AMAROS remains the evidence for what to do when the axilla does have to be treated."},{"id":"rejuv-trial-amico","kind":"trial","name":"AMICO: aerobic or resistance exercise to improve outcome in metastatic colorectal cancer","aka":["AMICO","NCT04754672"],"tldr":"CHALLENGE showed exercise improves survival after curative treatment for colon cancer. AMICO asks the next question, in advanced disease, with chemotherapy dose modification and progression-free survival as its primary endpoints, and uses an adaptive design to drop an ineffective exercise prescription early.","summary":"The trial's own stated rationale is the one this front keeps returning to: evidence from randomised trials shows that exercise during cancer treatment benefits physical fitness, fatigue and quality of life, and because the effect on clinical outcome was unknown, exercise is not included as an integral part of standard cancer care. AMICO tests clinical outcome directly in a different setting from CHALLENGE, during palliative chemotherapy rather than after curative treatment.\n\nThree arms: continuous aerobic exercise with resistance training, continuous aerobic exercise with high-intensity aerobic intervals, and usual care with an exercise-guidelines brochure. The two exercise arms are two supervised 60-minute sessions a week with a physiotherapist. The hypothesis is that exercise reduces chemotherapy dose modifications, which the protocol notes occur in about 40 per cent of patients with metastatic colorectal cancer and may reduce the benefit of treatment, and secondarily that it improves natural killer cell function. Co-primary endpoints are the number of patients requiring dose modifications and progression-free survival.\n\nThe design is the part worth noting for the field. It is a Bayesian adaptive multi-arm multi-stage trial with interim analyses that can drop an ineffective arm early, which is the efficiency the survivorship platform-trial proposal on this front generalises. Comparing two exercise prescriptions head to head, rather than exercise against nothing, is also the dose-finding question that exercise oncology has mostly skipped.\n\nThe registry records no phase for this study, as it tests a behavioural intervention rather than a drug; it is filed here as phase 3 because OnCo's schema has no value for an unphased randomised trial, and the registry entry is linked so the reader can check. Registry dates, read on 2 October 2026: start 2 March 2021 (actual), primary completion March 2026 (estimated), completion December 2026 (estimated). Enrolment of 228 is the registry's estimate.","status":"recruiting","asOf":"2026-10-02","links":[{"label":"ClinicalTrials.gov NCT04754672","url":"https://clinicaltrials.gov/study/NCT04754672"},{"label":"Courneya et al., Structured exercise after adjuvant chemotherapy for colon cancer, the CHALLENGE trial (NEJM 2025;393:13-25)","url":"https://doi.org/10.1056/NEJMoa2502760"}],"tags":["rejuvenation","survivorship","open-problem","exercise","trial-design"],"related":["challenge","exercise-prescription-after-cancer","structured-exercise-survivorship","exercise-oncology","idea-rejuv-survivorship-platform-trial","idea-nl-exercise-dose-finding","rejuvenation-roadmap"],"cancers":["colorectal"],"sections":["rejuvenation","supportive-care"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04754672","phase":"3","setting":"Adults with metastatic colorectal cancer receiving palliative chemotherapy, Netherlands, 13 collaborating centres","sponsor":"Radboud University Medical Center","started":"2021-03-02","startedType":"actual","enrolled":228,"enrolledBasis":"registry","outcomes":[]},{"id":"ampect","kind":"trial","name":"AMPECT","aka":[],"tldr":"A single-arm trial of albumin-bound sirolimus in the ultra-rare tumour PEComa produced lasting responses in about four in ten patients and won the first approval for the disease.","summary":"AMPECT enrolled 34 patients with advanced malignant perivascular epithelioid cell tumour, 31 evaluable, treated with intravenous nab-sirolimus on days 1 and 8 of 21-day cycles. The independently assessed objective response rate was 39 percent, responses were durable and were seen mainly in tumours with TSC2 mutations, and toxicity was consistent with mTOR inhibition (mucositis, rash, hyperglycaemia). Published in the Journal of Clinical Oncology in 2021, it led to FDA approval of nab-sirolimus (Fyarro) in November 2021, the first drug approved for PEComa, and to the PRECISION 1 basket trial in TSC1/TSC2-altered solid tumours.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02494570","url":"https://clinicaltrials.gov/study/NCT02494570"},{"label":"Journal of Clinical Oncology 2021","url":"https://doi.org/10.1200/JCO.21.01728"}],"tags":["subtype-page"],"related":[],"cancers":["pecoma","sarcoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["mtor"],"drugs":["sirolimus-albumin-bound"],"companies":["aadi-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02494570","phase":"2","setting":"Advanced malignant PEComa: nab-sirolimus (albumin-bound sirolimus)","sponsor":"Aadi Bioscience","result":"Objective response 39% (independent review), durable, enriched in TSC2-mutant tumours; FDA approval November 2021.","started":"2015-10","yearReported":2021,"enrolled":34,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (independent review)","primary":true,"unit":"percent","arms":[{"name":"Nab-sirolimus","n":31,"value":39}],"source":"https://doi.org/10.1200/JCO.21.01728"}]},{"id":"ample","kind":"trial","name":"AMPLE","aka":["Australasian Malignant Pleural Effusion trial"],"tldr":"Asked the question that matters when time is measured in months, how many days will I spend in hospital, and found the home drain wins by about three.","summary":"AMPLE recruited from nine centres in Australia, New Zealand, Singapore and Hong Kong between July 2012 and October 2014 and randomised 146 patients with symptomatic malignant pleural effusion to an indwelling pleural catheter (74) or talc pleurodesis (72), minimised by malignancy (mesothelioma against others) and trapped lung, stratified by region and followed for twelve months. Two withdrew before the intervention. Median age was 70.5 years and 56.2 percent were male.\n\nThe catheter group spent significantly fewer days in hospital: median 10.0 days (interquartile range 3 to 17) against 12.0 (7 to 21), p=0.03, Hodges-Lehmann estimate of difference 2.92 days (95 percent confidence interval 0.43 to 5.84). Breathlessness and quality of life did not differ.\n\nTogether with TIME2, AMPLE settled the argument: neither method controls symptoms better, so the choice turns on how much hospital time a patient is willing to spend, whether the lung re-expands, and whether there is someone at home able to drain the catheter. A patient with a trapped lung cannot be pleurodesed at all and needs the catheter.","status":"positive","asOf":"2026-09-25","links":[{"label":"AMPLE (JAMA 2017)","url":"https://doi.org/10.1001/jama.2017.17426"}],"tags":[],"related":[],"cancers":["nsclc","sclc","lung-cancer","pleural-mesothelioma"],"sections":[],"technologies":["palliative-care"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["palliative-treatment","pleural-effusion","quality-of-life"],"trials":["time2"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Symptomatic malignant pleural effusion without previous catheter or pleurodesis: indwelling pleural catheter versus talc pleurodesis, with total days in hospital from procedure to death or twelve months as the primary endpoint","sponsor":"Sir Charles Gairdner Hospital, Perth","result":"Median total hospital days 10.0 against 12.0 (p=0.03, difference 2.92 days); breathlessness and quality of life equivalent.","yearReported":2017,"enrolled":146,"enrolledBasis":"registry","outcomes":[{"endpoint":"Total days in hospital to death or 12 months (median)","primary":true,"unit":"days","arms":[{"name":"Indwelling pleural catheter","n":74,"value":10},{"name":"Talc pleurodesis","n":72,"value":12}],"p":"0.03","source":"https://doi.org/10.1001/jama.2017.17426"}],"replication":"Consistent with TIME2, which found equivalent breathlessness control and fewer hospital days with the catheter."},{"id":"amplify","kind":"trial","name":"AMPLIFY","aka":[],"tldr":"AMPLIFY is the trial behind the first all-oral, fixed-duration CLL regimen approved in the US (February 2026): 14 cycles of two pills, then stop.","summary":"AMPLIFY, trial NCT03836261 sponsored by AstraZeneca and published in the New England Journal of Medicine in 2025, is the trial behind the first all-oral, fixed-duration regimen approved for chronic lymphocytic leukaemia in the United States on 19 February 2026: fourteen cycles of acalabrutinib and venetoclax, then stop. It randomised 867 fit, previously untreated patients without del(17p) to acalabrutinib plus venetoclax, the same with obinutuzumab, or chemoimmunotherapy, met its primary progression-free survival endpoint for both experimental arms at three years, and showed a survival advantage for the doublet partly driven by COVID-19 deaths in the chemotherapy arm. Whether the triplet is worth its extra toxicity is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03836261","url":"https://clinicaltrials.gov/study/NCT03836261"},{"label":"FDA approval (19 Feb 2026)","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-venetoclax-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma"}],"tags":[],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["btk","bcl2","cd20"],"drugs":["acalabrutinib","venetoclax","obinutuzumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["ighv-status","del17p-tp53"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03836261","phase":"3","setting":"Fit, previously untreated CLL without del(17p)/TP53: fixed-duration acalabrutinib + venetoclax (AV) or + obinutuzumab (AVO) vs FCR/BR chemoimmunotherapy","sponsor":"AstraZeneca","result":"3-year PFS 76.5% (AV) / 83.1% (AVO) vs 66.5%.","started":"2019-02-25","startedType":"actual","yearReported":2024,"enrolled":867,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Acalabrutinib + venetoclax","n":291,"value":76.5},{"name":"Acalabrutinib + venetoclax + obinutuzumab","n":286,"value":83.1},{"name":"Chemoimmunotherapy (FCR/BR)","n":290,"value":66.5}],"source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-venetoclax-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma"},{"endpoint":"Progression-free survival (AV vs CIT)","arms":[{"name":"Acalabrutinib + venetoclax"},{"name":"Chemoimmunotherapy"}],"hr":0.65,"ci":[0.49,0.87],"source":"https://doi.org/10.1056/NEJMoa2409804"}],"replication":"GLOW and CAPTIVATE (ibrutinib-venetoclax), CLL13 (venetoclax-obinutuzumab ± ibrutinib), and SEQUOIA arm D (zanubrutinib-venetoclax) all show BTKi + BCL2i fixed-duration efficacy; the class effect is robust across three BTK inhibitors."},{"id":"amplify-7p","kind":"trial","name":"AMPLIFY-7P","aka":[],"tldr":"The randomised test of an off-the-shelf KRAS vaccine after pancreatic surgery. It missed its primary goal in June 2026.","summary":"Did not meet the pre-specified primary DFS endpoint in the intent-to-treat population; post-hoc landmark analyses suggested ~14% absolute DFS benefit during active dosing. Company is exploring R0-resected subgroups for phase 3. A cautionary data point for shared-antigen vaccines versus personalised approaches.","status":"negative","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT05726864","url":"https://clinicaltrials.gov/study/NCT05726864"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["shared-antigen-vaccine"],"targets":[],"drugs":["eli-002-7p"],"companies":["elicio-therapeutics"],"institutions":[],"pathways":[],"terms":["pancreatic-failed-programmes"],"trials":["eclipse","autogene-cevumeran-phase-1","nct05968326"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05726864","phase":"1/2","setting":"Adjuvant mKRAS PDAC after surgery and chemotherapy: ELI-002 7P vs observation","sponsor":"Elicio Therapeutics","result":"Primary DFS endpoint not met.","started":"2023-04-14","startedType":"actual","yearReported":2026,"enrolled":158,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival (ITT)","primary":true,"unit":"months","arms":[{"name":"ELI-002 7P","note":"Primary endpoint not met (sponsor release, 15 June 2026); ITT hazard ratio and medians not disclosed."},{"name":"Observation"}],"source":"https://elicio.com/press_releases/elicio-therapeutics-reports-results-from-phase-2-amplify-7p-study-and-outlines-refined-phase-3-development-strategy-for-eli-002-7p-in-adjuvant-pancreatic-cancer/"},{"endpoint":"Disease-free survival at 3 months (landmark)","unit":"%","arms":[{"name":"ELI-002 7P","value":90.3},{"name":"Observation","value":76.6}],"p":"0.022","source":"https://elicio.com/press_releases/elicio-therapeutics-reports-results-from-phase-2-amplify-7p-study-and-outlines-refined-phase-3-development-strategy-for-eli-002-7p-in-adjuvant-pancreatic-cancer/"},{"endpoint":"Disease-free survival, R0-resected subgroup (post hoc)","unit":"months","arms":[{"name":"ELI-002 7P","value":23.8,"note":"Post hoc analysis of 121 R0-resected patients; hypothesis-generating only."},{"name":"Observation","value":12.8}],"hr":0.65,"p":"0.048","source":"https://elicio.com/press_releases/elicio-therapeutics-reports-results-from-phase-2-amplify-7p-study-and-outlines-refined-phase-3-development-strategy-for-eli-002-7p-in-adjuvant-pancreatic-cancer/"}],"replication":"Randomised phase 2 missed its primary ITT endpoint (June 2026); the post hoc R0 subgroup signal is unreplicated and the sponsor plans a refined phase 3."},{"id":"nct07130903","kind":"trial","name":"Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of fruquintinib in colorectal cancer, run by Barbara Ann Karmanos Cancer Institute, now recruiting.","summary":"Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT07130903 by Barbara Ann Karmanos Cancer Institute, with a registry enrolment figure of 102 participants, started 2025-09-10 and due to reach its primary completion in 2028-04-17. Interventions recorded: Fruquintinib; TheraBionic P1. Conditions listed: Metastatic Colorectal Adenocarcinoma. Primary outcome: Overall Survival (OS). Colorectal eligibility wording from the registry: \"* Participant must have histologically or cytologically confirmed metastatic colorectal adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07130903","url":"https://clinicaltrials.gov/study/NCT07130903"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors","thermal-ablation"],"targets":[],"drugs":["fruquintinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07130903","phase":"2","setting":"A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer","sponsor":"Barbara Ann Karmanos Cancer Institute","started":"2025-09-10","startedType":"actual","enrolled":102,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07590531","kind":"trial","name":"AMT-116 in Combination With AK112 in Patients With Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of Ivonescimab in non-small-cell lung cancer and small-cell lung cancer, run by Multitude Therapeutics Inc., now recruiting.","summary":"AMT-116 in Combination With AK112 in Patients With Lung Cancer is a phase 1/2 interventional study registered as NCT07590531 by Multitude Therapeutics Inc., with 118 participants planned, started 2026-06-29 and due to reach its primary completion in 2027-05-30. Interventions recorded: AMT-116, AK112. Conditions listed: Advanced Non-small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07590531","url":"https://clinicaltrials.gov/study/NCT07590531"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab"],"companies":["multitude-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07590531","phase":"1/2","setting":"An Open-label, Multicenter Phase Ib/II Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMT116 in Combination With Ivonescimab (AK112) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)","sponsor":"Multitude Therapeutics Inc.","started":"2026-06-29","startedType":"actual","enrolled":118,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06782334","kind":"trial","name":"AMT-116 in Patients with Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of AMT-116 in advanced solid tumours, run by Multitude Therapeutics Inc., now recruiting.","summary":"AMT-116 in Patients with Solid Tumors is a phase 1/2 interventional study registered as NCT06782334 by Multitude Therapeutics Inc., with 144 participants planned, started 2024-05-07 and due to reach its primary completion in 2026-06-30. Interventions recorded: AMT-116.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06782334","url":"https://clinicaltrials.gov/study/NCT06782334"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["amt-116"],"companies":["multitude-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06782334","phase":"1/2","setting":"Phase 1/2 Study of AMT-116 in Patients with Advanced Solid Tumors","sponsor":"Multitude Therapeutics Inc.","started":"2024-05-07","startedType":"actual","enrolled":144,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06209580","kind":"trial","name":"AMT-253 in Patients With Advanced Solid Tumours","aka":[],"tldr":"A phase 1/2 trial of AMT-253 for injection in melanoma, run by Multitude Therapeutics Inc., now recruiting.","summary":"AMT-253 in Patients With Advanced Solid Tumours is a phase 1/2 interventional study registered as NCT06209580 by Multitude Therapeutics Inc., with 96 participants planned, started 2024-01-31 and due to reach its primary completion in 2026-04-30. Interventions recorded: AMT-253 for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06209580","url":"https://clinicaltrials.gov/study/NCT06209580"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["multitude-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06209580","phase":"1/2","setting":"Phase I/II Study of AMT-253 in Patients With Unresectable or Metastatic Malignant Melanoma and Other Advanced Solid Tumors","sponsor":"Multitude Therapeutics Inc.","started":"2024-01-31","startedType":"actual","enrolled":96,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04443543","kind":"trial","name":"An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of fOLFIRI (5-FU, leucovorin, irinotecan), fOLFOX (5-FU, leucovorin, oxaliplatin) and tislelizumab in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT04443543 by Fudan University, with a registry enrolment figure of 222 participants, started 2020-06-22 and due to reach its primary completion in 2026-06-30. Interventions recorded: Capecitabine (Xeloda) Pharmacogenetic Test Reagents; irinotecan; IMRT; Oxaliplatin; 5Fluorouracil; Tislelizumab. Conditions listed: Rectal Cancer. Primary outcome: clinical complete response rate. Colorectal eligibility wording from the registry: \"* difficult to achieve complete response assessed by current evidence: the maximal diameter of tumor \\>10cm; the maximal diameter of lateral lymph node \\>2cm; baseline CEA\\>=100; biopsy pathology confirmed signet ring cell carcinoma components; digital rectal examination found that the tumor is peri\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04443543","url":"https://clinicaltrials.gov/study/NCT04443543"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfiri","folfox","tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04443543","phase":"2","setting":"Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Chemoradiotherapy: A Multi-centre, Adaptive-design, Phase II Prospective Cohort Study","sponsor":"Fudan University","started":"2020-06-22","startedType":"estimated","enrolled":222,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06693336","kind":"trial","name":"An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Paclitaxel / nab-paclitaxel in non-small-cell lung cancer and small-cell lung cancer, run by ToLymph Inc., now recruiting.","summary":"An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT06693336 by ToLymph Inc., with 42 participants planned, started 2024-11-18 and due to reach its primary completion in 2026-11-18. Interventions recorded: SMS001. Conditions listed: Carcinoma, Non-Small-Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06693336","url":"https://clinicaltrials.gov/study/NCT06693336"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06693336","phase":"2","setting":"Phase IIa Trial Evaluating the Safety and Therapeutic Effect of SMS001 as an Adjuvant Therapy to Control Tumor Recurrence in Stage Ib-IIIa (N2) Non-Small Cell Lung Cancer (NSCLC) Patients","sponsor":"ToLymph Inc.","started":"2024-11-18","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05876754","kind":"trial","name":"An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma","aka":["ProvIDHe"],"tldr":"A phase 3 trial of Ivosidenib in biliary tract cancer, run by Servier Affaires Médicales, active and no longer recruiting.","summary":"An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma is a phase 3 interventional study registered as NCT05876754 by Servier Affaires Médicales, with 299 participants enrolled, started 2023-05-03 and due to reach its primary completion in 2027-12-01. Interventions recorded: Ivosidenib Oral Tablet.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05876754","url":"https://clinicaltrials.gov/study/NCT05876754"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["epigenetic-drugs","idh-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["ivosidenib"],"companies":["servier"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05876754","phase":"3","setting":"An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma","sponsor":"Servier Affaires Médicales","started":"2023-05-03","startedType":"actual","enrolled":299,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07293754","kind":"trial","name":"An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors","aka":["RaPTR-101"],"tldr":"A phase 1/2 trial of RPTR-1-201 in advanced solid tumours, run by Repertoire Immune Medicines, now recruiting.","summary":"An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07293754 by Repertoire Immune Medicines, with 150 participants planned, started 2025-12-12 and due to reach its primary completion in 2028-12-15. Interventions recorded: RPTR-1-201 and PD-1 / PD-L1 monoclonal antibody.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07293754","url":"https://clinicaltrials.gov/study/NCT07293754"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["pd1","pdl1"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07293754","phase":"1/2","setting":"A Phase 1/2 Trial of RPTR-1-201, a T Cell Receptor Bispecific Therapy, in Advanced Solid Tumors","sponsor":"Repertoire Immune Medicines","started":"2025-12-12","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02257736","kind":"trial","name":"An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)","aka":[],"tldr":"A phase 3 trial of Apalutamide, Abiraterone acetate and Prednisone in prostate cancer, run by Aragon Pharmaceuticals, Inc., active and no longer recruiting.","summary":"An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) is a phase 3 interventional study registered as NCT02257736 by Aragon Pharmaceuticals, Inc., with 982 participants enrolled, started 2014-11-26 and due to reach its primary completion in 2018-03-19. Interventions recorded: Apalutamide, Abiraterone acetate, Prednisone and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02257736","url":"https://clinicaltrials.gov/study/NCT02257736"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["apalutamide","abiraterone","prednisone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02257736-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02257736","phase":"3","setting":"A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)","sponsor":"Aragon Pharmaceuticals, Inc.","started":"2014-11-26","startedType":"actual","yearReported":2021,"enrolled":982,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic Progression-free Survival (rPFS)","primary":true,"unit":"months","arms":[{"name":"Placebo+ Abiraterone Acetate - Prednisolone","n":490,"value":16.59,"note":"95% CI 13.86 to 19.32; Figures from the ClinicalTrials.gov results section (first posted 2021-08-16), not from a publication"},{"name":"Apalutamide + Abiraterone Acetate - Prednisolone","n":492,"value":23.98,"note":"95% CI 19.71 to 27.50"}],"source":"https://clinicaltrials.gov/study/NCT02257736?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Placebo+ Abiraterone Acetate - Prednisolone","n":490,"value":33.71,"note":"95% CI 31.24 to 38.28; Figures from the ClinicalTrials.gov results section (first posted 2021-08-16), not from a publication"},{"name":"Apalutamide + Abiraterone Acetate - Prednisolone","n":492,"value":36.17,"note":"95% CI 32.76 to 38.77"}],"source":"https://clinicaltrials.gov/study/NCT02257736?tab=results"}]},{"id":"nct04076059","kind":"trial","name":"An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormo","aka":["China ARCHES"],"tldr":"A phase 3 trial of Enzalutamide in prostate cancer, run by Astellas (Beijing) Pharmaceutical R&D Co., Ltd., active and no longer recruiting.","summary":"An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) is a phase 3 interventional study registered as NCT04076059 by Astellas (Beijing) Pharmaceutical R&D Co., Ltd., with 180 participants enrolled, started 2019-09-11 and due to reach its primary completion in 2022-11-18. Interventions recorded: Enzalutamide, Placebo, Androgen deprivation therapy (ADT). Conditions listed: Metastatic Hormone Sensitive Prostate Cancer. Results were posted on ClinicalTrials.gov in 2023; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04076059","url":"https://clinicaltrials.gov/study/NCT04076059"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["enzalutamide"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04076059","phase":"3","setting":"China ARCHES: A Multicenter, Phase 3, Randomized, Double-blind, Placebo Controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)","sponsor":"Astellas (Beijing) Pharmaceutical R&D Co., Ltd.","started":"2019-09-11","startedType":"actual","yearReported":2023,"enrolled":180,"enrolledBasis":"registry","outcomes":[{"endpoint":"Time to Prostrate Specific Antigen (PSA) Progression","primary":true,"unit":"months","arms":[{"name":"Enzalutamide Plus Androgen Deprivation Therapy (ADT) (Double Blind Phase)","n":120,"note":"Not Reached. Data was not estimable due to low number of events; Figures from the ClinicalTrials.gov results section (first posted 2023-11-18), not from a publication"},{"name":"Placebo Plus ADT (Double Blind Phase)","n":60,"value":9.2,"note":"95% CI 6.54 to 17.48"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT04076059?tab=results"},{"endpoint":"Radiographic Progression-Free Survival (rPFS)","unit":"months","arms":[{"name":"Enzalutamide Plus Androgen Deprivation Therapy (ADT) (Double Blind Phase)","n":120,"note":"Not Reached. Median and upper CI was not estimable due to low number of events; Figures from the ClinicalTrials.gov results section (first posted 2023-11-18), not from a publication"},{"name":"Placebo Plus ADT (Double Blind Phase)","n":60,"value":19.4,"note":"95% CI 13.63 to NA"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT04076059?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"Enzalutamide Plus Androgen Deprivation Therapy (ADT) (Double Blind Phase)","n":47,"value":76.6,"note":"95% CI 62.0 to 87.7; Figures from the ClinicalTrials.gov results section (first posted 2023-11-18), not from a publication"},{"name":"Placebo Plus ADT (Double Blind Phase)","n":22,"value":81.8,"note":"95% CI 59.7 to 94.8"}],"p":"0.8312","source":"https://clinicaltrials.gov/study/NCT04076059?tab=results"}]},{"id":"nct02365597","kind":"trial","name":"An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer","aka":[],"tldr":"A phase 2 trial of Erdafitinib in bladder & urothelial cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer is a phase 2 interventional study registered as NCT02365597 by Janssen Research & Development, LLC, with 239 participants enrolled, started 2015-04-22 and due to reach its primary completion in 2022-09-15. Interventions recorded: Erdafitinib, Midazolam and Metformin. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02365597","url":"https://clinicaltrials.gov/study/NCT02365597"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["erdafitinib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02365597","phase":"2","setting":"A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations","sponsor":"Janssen Research & Development, LLC","started":"2015-04-22","startedType":"actual","yearReported":2023,"enrolled":239,"enrolledBasis":"registry","outcomes":[{"endpoint":"Main Study: Percentage of Participants With Best (Overall) Objective Response","primary":true,"unit":"%","arms":[{"name":"Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg","n":33,"value":21.2,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-10-10), not from a publication"},{"name":"Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg","n":78,"value":34.6},{"name":"Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg","n":101,"value":39.6}],"source":"https://clinicaltrials.gov/study/NCT02365597?tab=results"},{"endpoint":"Main Study: Overall Survival","unit":"months","arms":[{"name":"Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg","n":33,"value":7.46,"note":"range 1.7 to 64.0; Figures from the ClinicalTrials.gov results section (first posted 2023-10-10), not from a publication"},{"name":"Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg","n":78,"value":8.64,"note":"range 0.4 to 60.1"},{"name":"Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg","n":101,"value":11.3,"note":"range 0.7 to 56.9"}],"source":"https://clinicaltrials.gov/study/NCT02365597?tab=results"},{"endpoint":"Main Study: Progression-free Survival (PFS)","unit":"months","arms":[{"name":"Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg","n":33,"value":4.8,"note":"range 1.1 to 25.3; Figures from the ClinicalTrials.gov results section (first posted 2023-10-10), not from a publication"},{"name":"Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg","n":78,"value":5.26,"note":"range 0.4 to 57.9"},{"name":"Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg","n":101,"value":5.52,"note":"range 0.0 to 51.5"}],"source":"https://clinicaltrials.gov/study/NCT02365597?tab=results"}]},{"id":"nct02531516","kind":"trial","name":"An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS","aka":["ATLAS"],"tldr":"A phase 3 trial of Apalutamide and Bicalutamide in prostate cancer, run by Aragon Pharmaceuticals, Inc., active and no longer recruiting.","summary":"An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS is a phase 3 interventional study registered as NCT02531516 by Aragon Pharmaceuticals, Inc., with 1503 participants enrolled, started 2015-11-19 and due to reach its primary completion in 2027-03-01. Interventions recorded: Apalutamide, Bicalutamide, Bicalutamide Placebo, Apalutamide Placebo, GnRH (agonist) and 74-80 Grays (units of radiation).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02531516","url":"https://clinicaltrials.gov/study/NCT02531516"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["apalutamide","bicalutamide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02531516","phase":"3","setting":"ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy","sponsor":"Aragon Pharmaceuticals, Inc.","started":"2015-11-19","startedType":"actual","enrolled":1503,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04717414","kind":"trial","name":"An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomi","aka":["INDEPENDENCE"],"tldr":"A phase 3 trial of Luspatercept in myeloproliferative neoplasms, run by Celgene, active and no longer recruiting.","summary":"An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions is a phase 3 interventional study registered as NCT04717414 by Celgene, with 313 participants enrolled, started 2021-02-25 and due to reach its primary completion in 2025-05-26. Interventions recorded: ACE-536, Placebo. Conditions listed: Myeloproliferative Disorders, Myelofibrosis, Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04717414","url":"https://clinicaltrials.gov/study/NCT04717414"}],"tags":["ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","primary-myelofibrosis"],"sections":[],"technologies":["transfusion-support"],"targets":[],"drugs":["luspatercept"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04717414","phase":"3","setting":"A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK Inhibitor Therapy and Who Require Red Blood Cell Transfusions","sponsor":"Celgene","started":"2021-02-25","startedType":"actual","yearReported":2026,"enrolled":313,"enrolledBasis":"registry","outcomes":[{"endpoint":"Red Blood Cell-transfusion Independence (RBC-TI) ≥ 12 Weeks (RBC-TI 12)","primary":true,"unit":"%","arms":[{"name":"Treatment","n":208,"value":23.08,"note":"95% CI 17.53 to 29.41; Figures from the ClinicalTrials.gov results section (first posted 2026-07-16), not from a publication"},{"name":"Control","n":105,"value":13.33,"note":"95% CI 7.49 to 21.36"}],"p":"0.0674","source":"https://clinicaltrials.gov/study/NCT04717414?tab=results"}]},{"id":"nct05413018","kind":"trial","name":"An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission","aka":[],"tldr":"A phase 2 trial of CC-486 in acute myeloid leukaemia, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission is a phase 2 interventional study registered as NCT05413018 by Bristol-Myers Squibb, with 34 participants enrolled, started 2022-08-19 and due to reach its primary completion in 2025-10-31. Interventions recorded: CC-486.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05413018","url":"https://clinicaltrials.gov/study/NCT05413018"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05413018","phase":"2","setting":"A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine (CC-486) Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Chinese Patients With Acute Myeloid Leukemia in Complete Remission","sponsor":"Bristol-Myers Squibb","started":"2022-08-19","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03897881","kind":"trial","name":"An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYN","aka":[],"tldr":"A phase 2 trial of Intismeran autogene, Pembrolizumab in melanoma, run by ModernaTX, Inc., active and no longer recruiting.","summary":"An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942) is a phase 2 interventional study registered as NCT03897881 by ModernaTX, Inc., with 267 participants enrolled, started 2019-07-18 and due to reach its primary completion in 2032-11-21. Interventions recorded: mRNA-4157, Pembrolizumab. Conditions listed: Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03897881","url":"https://clinicaltrials.gov/study/NCT03897881"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["intismeran-autogene","pembrolizumab"],"companies":["moderna"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-keynote-942-lancet-2024","paper-nct03897881-j-clin-oncol-2026-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03897881","phase":"2","setting":"A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma (KEYNOTE- 942)","sponsor":"ModernaTX, Inc.","started":"2019-07-18","startedType":"actual","enrolled":267,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07033026","kind":"trial","name":"An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia.","aka":[],"tldr":"A phase 2 trial of NGM120 Q4W in colorectal cancer, run by NGM Biopharmaceuticals, Inc, now recruiting.","summary":"An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia. is a phase 2 interventional study registered as NCT07033026 by NGM Biopharmaceuticals, Inc, with 136 participants planned, started 2025-06-25 and due to reach its primary completion in 2027-04. Interventions recorded: NGM120 Q4W, NGM120 Q8W and Placebo given.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07033026","url":"https://clinicaltrials.gov/study/NCT07033026"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07033026","phase":"2","setting":"A Phase 2, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in Participants With Colorectal Cancer Who Have Cancer Cachexia","sponsor":"NGM Biopharmaceuticals, Inc","started":"2025-06-25","startedType":"actual","enrolled":136,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07061210","kind":"trial","name":"An Explorative Study of HRS-2189 Combined With Adebrelimab and BP102 for Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of adebrelimab in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"An Explorative Study of HRS-2189 Combined With Adebrelimab and BP102 for Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT07061210 by Fudan University, with a registry enrolment figure of 20 participants, started 2025-07-01 and due to reach its primary completion in 2026-10-01. Interventions recorded: HRS-2189; Adebrelimab; BP102. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Objective response rate (ORR). Colorectal eligibility wording from the registry: \"Histological confirmed metastatic colorectal cancer; 3\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07061210","url":"https://clinicaltrials.gov/study/NCT07061210"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07061210","phase":"2","setting":"An Explorative Study of HRS-2189 Combined With Adebrelimab and BP102 for Metastatic Colorectal Cancer","sponsor":"Fudan University","started":"2025-07-01","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06938282","kind":"trial","name":"An Exploratory Clinical Study of HRS-4642 in Combination With Immunotherapy and Chemotherapy for Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Shanghai Zhongshan Hospital, now recruiting.","summary":"An Exploratory Clinical Study of HRS-4642 in Combination With Immunotherapy and Chemotherapy for Pancreatic Cancer is a phase 2, interventional study registered as NCT06938282 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 60 participants, started 2025-06-23 and due to reach its primary completion in 2027-04-30. Interventions recorded: HRS-4642. Conditions listed: Pancreatic Cancer. Primary outcome: Adverse events (AEs); Arm 1:Objective Response Rate (ORR); Arm 2:18m-OS rate. Pancreatic eligibility wording from the registry: \"Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06938282","url":"https://clinicaltrials.gov/study/NCT06938282"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06938282","phase":"2","setting":"An Exploratory Clinical Study of HRS-4642 in Combination With Immunotherapy and Chemotherapy for Pancreatic Cancer","sponsor":"Shanghai Zhongshan Hospital","started":"2025-06-23","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07631871","kind":"trial","name":"An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy","aka":[],"tldr":"A phase 2 trial of zanidatamab in pancreatic cancer, run by Haihua Yuan, not yet recruiting.","summary":"An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy is a phase 2, interventional study registered as NCT07631871 by Haihua Yuan, with a registry enrolment figure of 10 participants, started 2026-06-15 and due to reach its primary completion in 2029-12-31. Interventions recorded: Zanidatamab. Conditions listed: Neoplasms; Solid Tumors; HER2 Positive Solid Tumor; Endometrial Neoplasm; Urothelial Carcinoma (UC); Pancreatic Neoplasms; Colorectal Neoplasms; Head and Neck Neoplasms; Cervical Neoplasms; Ovarian Neoplasms. Primary outcome: Objective Response Rate, ORR. Pancreatic eligibility wording from the registry: \"Qualified tumor types include but are not limited to endometrial carcinoma, urothelial carcinoma, pancreatic cancer, colorectal carcinoma (CRC), head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary of the neck), cervical cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07631871","url":"https://clinicaltrials.gov/study/NCT07631871"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["zanidatamab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07631871","phase":"2","setting":"An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy","sponsor":"Haihua Yuan","started":"2026-06-15","startedType":"estimated","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07282262","kind":"trial","name":"An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy.","aka":[],"tldr":"A phase 2 trial of lenvatinib and ivosidenib in gallbladder cancer and other biliary tract cancers, run by Peking Union Medical College Hospital, now recruiting.","summary":"An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy. is a phase 2 interventional study registered as NCT07282262 by Peking Union Medical College Hospital, with a registry enrolment figure of 300 participants, started 2024-05-01 and due to reach its primary completion in 2026-10-01. Interventions recorded: Ivosidenib, Lenvatinib, PD-1/PD-L1 inhibitor. Conditions listed: Biliary Tract Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07282262","url":"https://clinicaltrials.gov/study/NCT07282262"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer","intrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["kinase-inhibitors","idh-inhibitors"],"targets":[],"drugs":["lenvatinib","ivosidenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07282262","phase":"2","setting":"An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy.","sponsor":"Peking Union Medical College Hospital","started":"2024-05-01","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06560112","kind":"trial","name":"An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer","aka":[],"tldr":"A phase 2 trial of Cadonilimab, Ivonescimab in ovarian cancer, run by Akeso, now recruiting.","summary":"An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer is a phase 2 interventional study registered as NCT06560112 by Akeso, with 172 participants planned, started 2024-11-12 and due to reach its primary completion in 2026-05-01. Interventions recorded: AK104, AK112, Chemotherapy. Conditions listed: Recurrent Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06560112","url":"https://clinicaltrials.gov/study/NCT06560112"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["cadonilimab","ivonescimab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06560112","phase":"2","setting":"An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer","sponsor":"Akeso","started":"2024-11-12","startedType":"actual","enrolled":172,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01368276","kind":"trial","name":"An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma","aka":[],"tldr":"A phase 3 trial of Talimogene laherparepvec in Melanoma, run by BioVex Limited, completed.","summary":"An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma is a phase 3 interventional study registered as NCT01368276 by BioVex Limited, with 31 participants recorded, started 2010-10 and reaching its primary completion in 2014-09. Interventions recorded: Talimogene Laherparepvec, Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF). Conditions recorded: Melanoma.\n\nLinked to the drug Talimogene laherparepvec because the registry names it among its interventions and Melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01368276","url":"https://clinicaltrials.gov/study/NCT01368276"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["talimogene-laherparepvec"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01368276","phase":"3","setting":"An Extension Protocol to Evaluate the Efficacy and Safety of Extended Use Treatment With OncoVEX^GM-CSF for Eligible Melanoma Patients Participating in Study 005/05","sponsor":"BioVex Limited","started":"2010-10","yearReported":2015,"enrolled":31,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate","unit":"%","arms":[{"name":"GM-CSF","n":3,"value":100,"note":"95% CI NA to NA; Figures from the ClinicalTrials.gov results section (first posted 2015-12-18), not from a publication"},{"name":"Talimogene Laherparepvec","n":28,"value":57.1,"note":"95% CI 38.8 to 75.5"}],"p":"0.2645","source":"https://clinicaltrials.gov/study/NCT01368276?tab=results"}]},{"id":"nct06401356","kind":"trial","name":"An Extension Study for Patients Previously Enrolled in Studies With Pelabresib","aka":[],"tldr":"A phase 3 trial testing Pelabresib, now recruiting.","summary":"An Extension Study for Patients Previously Enrolled in Studies With Pelabresib is a phase 3 interventional study registered as NCT06401356, led by Novartis Pharmaceuticals, and recruiting on the registry. Official title: An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies With Pelabresib. Planned enrolment is 50 participants (estimated). The study started in 2024-08-13 and primary completion is expected in 2027-06-02. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06401356","url":"https://clinicaltrials.gov/study/NCT06401356"}],"tags":["ctgov-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":["pelabresib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06401356","phase":"3","setting":"An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies With Pelabresib","sponsor":"Novartis Pharmaceuticals","started":"2024-08-13","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05112965","kind":"trial","name":"An Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C)","aka":["IMbrella C"],"tldr":"A phase 3 trial of Atezolizumab, Bevacizumab, Pemetrexed and Enzalutamide in advanced solid tumours, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"An Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C) is a phase 3 interventional study registered as NCT05112965 by Hoffmann-La Roche, with 49 participants enrolled, started 2021-12-01 and due to reach its primary completion in 2027-06-30. Interventions recorded: Atezolizumab, Bevacizumab, Pemetrexed, Paclitaxel and Enzalutamide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05112965","url":"https://clinicaltrials.gov/study/NCT05112965"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab","bevacizumab","pemetrexed","enzalutamide"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05112965","phase":"3","setting":"An Open-Label, Multicenter Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C)","sponsor":"Hoffmann-La Roche","started":"2021-12-01","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03844048","kind":"trial","name":"An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial","aka":[],"tldr":"A phase 3 trial of Venetoclax in multiple myeloma and non-hodgkin lymphoma, run by AbbVie, active and no longer recruiting.","summary":"An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial is a phase 3 interventional study registered as NCT03844048 by AbbVie, with 165 participants enrolled, started 2019-09-06 and due to reach its primary completion in 2027-08. Interventions recorded: Venetoclax. Conditions listed: Chronic Lymphocytic Leukemia, Acute Myeloid Leukemia, Multiple Myeloma, Non-Hodgkin's Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03844048","url":"https://clinicaltrials.gov/study/NCT03844048"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","non-hodgkin-lymphoma"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["venetoclax"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03844048","phase":"3","setting":"An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial","sponsor":"AbbVie","started":"2019-09-06","startedType":"actual","enrolled":165,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07604766","kind":"trial","name":"An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Can","aka":["RAINFOL-02"],"tldr":"A phase 3 trial of Rinatabart sesutecan, Paclitaxel / nab-paclitaxel, Topotecan in ovarian cancer, run by Genmab, now recruiting.","summary":"An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China is a phase 3 interventional study registered as NCT07604766 by Genmab, with 82 participants planned, started 2026-06-26 and due to reach its primary completion in 2027-09. Interventions recorded: Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin (PLD), Gemcitabine. Conditions listed: Platinum-resistant Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07604766","url":"https://clinicaltrials.gov/study/NCT07604766"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["rinatabart-sesutecan","paclitaxel","topotecan","pegylated-liposomal-doxorubicin","gemcitabine"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07604766","phase":"3","setting":"A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer","sponsor":"Genmab","started":"2026-06-26","startedType":"actual","enrolled":82,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06557733","kind":"trial","name":"An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis is a phase 2, interventional study registered as NCT06557733 by National Cancer Institute (NCI), with a registry enrolment figure of 38 participants, started 2026-03-31 and due to reach its primary completion in 2027-06-30. Interventions recorded: Biopsy Procedure; Biospecimen Collection; EP2/EP4 Antagonist TPST-1495; Esophagogastroduodenoscopy; Gastrointestinal Endoscopy; Questionnaire Administration. Conditions listed: Colorectal Carcinoma; Familial Adenomatous Polyposis. Primary outcome: Percent change in duodenal polyp burden; Incidence of adverse events. Colorectal eligibility wording from the registry: \"* Clinical diagnosis of classic FAP with ≥ 100 colorectal adenomas status post colectomy or a sub-total colectomy and a family history of FAP\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06557733","url":"https://clinicaltrials.gov/study/NCT06557733"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06557733","phase":"2","setting":"Phase 2 Study to Evaluate the Efficacy and Safety of TPST-1495 in Patients With Familial Adenomatous Polyposis (FAP)","sponsor":"National Cancer Institute (NCI)","started":"2026-03-31","startedType":"actual","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06447103","kind":"trial","name":"An Investigational Scan (89Zr-DFO-GmAb PET/CT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer","aka":[],"tldr":"A phase 2 trial of CAIX PET in Clear cell renal cell carcinoma and Renal cell carcinoma, run by Jonsson Comprehensive Cancer Center, now recruiting.","summary":"An Investigational Scan (89Zr-DFO-GmAb PET/CT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer is a phase 2 interventional study registered as NCT06447103 by Jonsson Comprehensive Cancer Center, with 91 participants planned, started 2024-08-06 and due to reach its primary completion in 2029-12-01. Interventions recorded: Biospecimen Collection, Bone Scan, Computed Tomography, Magnetic Resonance Imaging, Positron Emission Tomography, Questionnaire Administration, Zirconium Zr 89 Girentuximab. Conditions recorded: Clear Cell Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage II Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer.\n\nLinked to the technology CAIX PET because the registry names it (\"89zr girentuximab\") among its interventions and Clear cell renal cell carcinoma and Renal cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06447103","url":"https://clinicaltrials.gov/study/NCT06447103"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["clear-cell-rcc","rcc"],"sections":[],"technologies":["caix-pet"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06447103","phase":"2","setting":"89Zr-DFO-GmAb PET/CT vs Contrast-Enhanced CT for Detection of Recurrent Clear Cell Renal Cell Carcinoma After Surgery","sponsor":"Jonsson Comprehensive Cancer Center","started":"2024-08-06","startedType":"actual","enrolled":91,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06634849","kind":"trial","name":"An Open Label Dose Finding Study of PTT-4256 in Patients With Solid Tumours (RAISIC-1).","aka":["RAISIC-1"],"tldr":"A phase 1/2 trial of PTT-4256 in advanced solid tumours, run by Pathios Therapeutics Pty Ltd, now recruiting.","summary":"An Open Label Dose Finding Study of PTT-4256 in Patients With Solid Tumours (RAISIC-1). is a phase 1/2 interventional study registered as NCT06634849 by Pathios Therapeutics Pty Ltd, with 30 participants planned, started 2024-11-04 and due to reach its primary completion in 2027-04-30. Interventions recorded: PTT-4256.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06634849","url":"https://clinicaltrials.gov/study/NCT06634849"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06634849","phase":"1/2","setting":"A Modular, Open Label, Dose Finding, Phase 1/2 Clinical Trial in Patients With Solid Tumours to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of PTT-4256.","sponsor":"Pathios Therapeutics Pty Ltd","started":"2024-11-04","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06668792","kind":"trial","name":"An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients With Relapsed/Refractory Multiple Myeloma","aka":["FLAMMINGO"],"tldr":"A phase 2 trial of BCD-248 in multiple myeloma, run by Biocad, now recruiting.","summary":"An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients With Relapsed/Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT06668792 by Biocad, with 100 participants planned, started 2024-12-26 and due to reach its primary completion in 2026-02. Interventions recorded: BCD-248.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06668792","url":"https://clinicaltrials.gov/study/NCT06668792"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["biocad"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06668792","phase":"2","setting":"An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Subjects With Relapsed/Refractory Multiple Myeloma","sponsor":"Biocad","started":"2024-12-26","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07206056","kind":"trial","name":"An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)","aka":["TulmiSTAR-01"],"tldr":"A phase 1/2 trial of Tulmimetostat DL1 QD in prostate cancer, run by Novartis Pharmaceuticals, now recruiting.","summary":"An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01) is a phase 1/2 interventional study registered as NCT07206056 by Novartis Pharmaceuticals, with 188 participants planned, started 2025-10-15 and due to reach its primary completion in 2029-11-09. Interventions recorded: Tulmimetostat DL1 QD, Tulmimetostat DL2 QD, Tulmimetostat DL3 QD, Tulmimetostat Doses 1 or 2 QD, Tulmimetostat RP2D QD and JSB462 Dose 1 QD.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07206056","url":"https://clinicaltrials.gov/study/NCT07206056"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07206056","phase":"1/2","setting":"TulmiSTAR-01: A Two-part, Phase I Dose Escalation and Expansion Followed by a Randomized, Open-label Multicenter, Phase II Study to Assess the Safety and Efficacy of the Combination of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) vs Standard of Care in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer","sponsor":"Novartis Pharmaceuticals","started":"2025-10-15","startedType":"actual","enrolled":188,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05022901","kind":"trial","name":"An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma","aka":[],"tldr":"A phase 3 trial of Melphalan in melanoma and uveal melanoma, run by Delcath Systems Inc., active and no longer recruiting.","summary":"An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma is a phase 3 interventional study registered as NCT05022901 by Delcath Systems Inc., with 30 participants planned, started 2022-06-10 and due to reach its primary completion in 2024-03-01. Interventions recorded: Melphalan (3 mg/kg IBW) with Hepatic Delivery System (HDS). Conditions listed: Metastatic Ocular Melanoma, Metastatic Uveal Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05022901","url":"https://clinicaltrials.gov/study/NCT05022901"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","uveal-melanoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","percutaneous-hepatic-perfusion"],"targets":[],"drugs":["melphalan"],"companies":["delcath"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05022901","phase":"3","setting":"An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma","sponsor":"Delcath Systems Inc.","started":"2022-06-10","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05884255","kind":"trial","name":"An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.","aka":[],"tldr":"A phase 3 trial of Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide in pancreatic ductal adenocarcinoma, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors. is a phase 3 interventional study registered as NCT05884255 by Jiangsu HengRui Medicine Co., Ltd., with 220 participants planned, started 2023-07-06 and due to reach its primary completion in 2026-12. Interventions recorded: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide and long-acting Octreotide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05884255","url":"https://clinicaltrials.gov/study/NCT05884255"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05884255","phase":"3","setting":"Randomized, Open, Positive Control Phase III Clinical Trial of Lutetium (177Lu) Oxodotreotide Injection Combined With Standard-dose Long-acting Octreotide Versus High-dose Long-acting Octreotide in the Treatment of Somatostatin Receptor-positive Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2023-07-06","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05907057","kind":"trial","name":"An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.","aka":[],"tldr":"A phase 3 trial of Ivosidenib and Azacitidine in acute myeloid leukaemia, run by Servier Affaires Médicales, now recruiting.","summary":"An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy. is a phase 3 interventional study registered as NCT05907057 by Servier Affaires Médicales, with 245 participants planned, started 2023-06-14 and due to reach its primary completion in 2027-10-15. Interventions recorded: Ivosidenib 500mg Oral Tablet and Azacitidine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05907057","url":"https://clinicaltrials.gov/study/NCT05907057"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-older-unfit"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs","idh-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["ivosidenib","azacitidine"],"companies":["servier"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05907057","phase":"3","setting":"A Single Arm, Open-label Phase 3b Study to Describe the Safety and Tolerability of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy","sponsor":"Servier Affaires Médicales","started":"2023-06-14","startedType":"actual","enrolled":245,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03533283","kind":"trial","name":"An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma","aka":[],"tldr":"A phase 1/2 trial of Glofitamab, Atezolizumab, Obinutuzumab, Tocilizumab and Polatuzumab vedotin in hodgkin lymphoma, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma is a phase 1/2 interventional study registered as NCT03533283 by Hoffmann-La Roche, with 211 participants enrolled, started 2018-05-08 and due to reach its primary completion in 2026-10-16. Interventions recorded: Glofitamab, Atezolizumab, Obinutuzumab, Tocilizumab, Polatuzumab Vedotin and 89Zr-Df-IAB22M2C.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03533283","url":"https://clinicaltrials.gov/study/NCT03533283"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma"],"sections":[],"technologies":["adc","checkpoint-inhibitor","monoclonal-antibody","t-cell-engager"],"targets":[],"drugs":["glofitamab","atezolizumab","obinutuzumab","tocilizumab","polatuzumab-vedotin"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03533283","phase":"1/2","setting":"An Open-Label, Multi-Center, Phase IB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin (Plus a Single Pre-Treatment Dose of Obinutuzumab) in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma","sponsor":"Hoffmann-La Roche","started":"2018-05-08","startedType":"actual","enrolled":211,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05939414","kind":"trial","name":"An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.","aka":[],"tldr":"A phase 3 trial of FAP-2286 in prostate cancer, run by Novartis Pharmaceuticals, now recruiting.","summary":"An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. is a phase 3 interventional study registered as NCT05939414 by Novartis Pharmaceuticals, with 450 participants planned, started 2024-03-12 and due to reach its primary completion in 2028-04-25. Interventions recorded: AAA617, piflufolastat (18F), gallium (68Ga) gozetotide (25μg). Conditions listed: Oligometastatic Prostate Cancer (OMPC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05939414","url":"https://clinicaltrials.gov/study/NCT05939414"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["fapi-pet","radioligand-therapy"],"targets":[],"drugs":["fap-2286"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05939414","phase":"3","setting":"An International, Prospective, Open-label, Multi-center, Randomized Phase III Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) Versus Observation to Delay Castration or Disease Recurrence in Adult Male Patients With Prostate-specific Membrane Antigen (PSMA) Positive Oligometastatic Prostate Cancer (OMPC)","sponsor":"Novartis Pharmaceuticals","started":"2024-03-12","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06991556","kind":"trial","name":"An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Canc","aka":[],"tldr":"A phase 2 trial of Abiraterone acetate, Enzalutamide in prostate cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) is a phase 2 interventional study registered as NCT06991556 by Novartis Pharmaceuticals, with 168 participants enrolled, started 2025-07-07 and due to reach its primary completion in 2032-02-13. Interventions recorded: JSB462, Abiraterone, Enzalutamide. Conditions listed: Metastatic Hormone-sensitive Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06991556","url":"https://clinicaltrials.gov/study/NCT06991556"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":[],"targets":[],"drugs":["abiraterone","enzalutamide"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06991556","phase":"2","setting":"A Phase II, Randomized, Open-label, Multi-center Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","sponsor":"Novartis Pharmaceuticals","started":"2025-07-07","startedType":"actual","enrolled":168,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06894511","kind":"trial","name":"An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC","aka":["PSMAndARPI"],"tldr":"A phase 2 trial of FAP-2286, Lutetium-177 vipivotide tetraxetan in prostate cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC is a phase 2 interventional study registered as NCT06894511 by Novartis Pharmaceuticals, with 7 participants enrolled, started 2025-09-11 and due to reach its primary completion in 2026-10-15. Interventions recorded: AAA617, ARPI: Abiraterone, ARPI: Enzalutamide. Conditions listed: Metastatic Castration Resistant Prostate Cancer (mCRPC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06894511","url":"https://clinicaltrials.gov/study/NCT06894511"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["fap-2286","pluvicto"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06894511","phase":"2","setting":"A Phase II, Open-label, Multi-Center, Randomized Study of Combination of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) and Androgen Receptor Pathway Inhibitor (ARPI) vs. Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in First-line Treatment of Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Progressive Metastatic Castration Resistant Prostate Cancer (mCRPC)","sponsor":"Novartis Pharmaceuticals","started":"2025-09-11","startedType":"actual","enrolled":7,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02955940","kind":"trial","name":"An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib","aka":[],"tldr":"A phase 2 trial of Ruxolitinib, Capecitabine, Regorafenib in colorectal cancer, run by Incyte Corporation, active and no longer recruiting.","summary":"An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib is a phase 2 interventional study registered as NCT02955940 by Incyte Corporation, with 10 participants enrolled, started 2016-11-30 and due to reach its primary completion in 2027-09-30. Interventions recorded: Ruxolitinib, Capecitabine, Regorafenib. Conditions listed: Pancreatic Cancer, Colorectal Cancer (CRC), Breast Cancer, Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02955940","url":"https://clinicaltrials.gov/study/NCT02955940"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ruxolitinib","capecitabine","regorafenib"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02955940","phase":"2","setting":"An Open-Label, Multicenter, Rollover Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib","sponsor":"Incyte Corporation","started":"2016-11-30","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07720284","kind":"trial","name":"An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC","aka":[],"tldr":"A phase 3 trial of Rilvegostomig, Durvalumab, Nivolumab, Pembrolizumab and Enfortumab vedotin in bladder & urothelial cancer, run by AstraZeneca, now recruiting.","summary":"An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC is a phase 3 interventional study registered as NCT07720284 by AstraZeneca, with 915 participants planned, started 2026-07-16 and due to reach its primary completion in 2030-09-11. Interventions recorded: Dato-DXd, Rilvegostomig, Durvalumab, Nivolumab, Pembrolizumab and Enfortumab vedotin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07720284","url":"https://clinicaltrials.gov/study/NCT07720284"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["rilvegostomig","durvalumab","nivolumab","pembrolizumab","enfortumab-vedotin"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07720284","phase":"3","setting":"A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma","sponsor":"AstraZeneca","started":"2026-07-16","startedType":"actual","enrolled":915,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04305795","kind":"trial","name":"An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab and Cemiplimab in head and neck squamous cell carcinoma and cutaneous squamous cell carcinoma, run by Rakuten Medical, Inc., active and no longer recruiting.","summary":"An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT04305795 by Rakuten Medical, Inc., with 23 participants enrolled, started 2020-12-21 and due to reach its primary completion in 2026-06. Interventions recorded: 200 mg Pembrolizumab, 350 mg Cemiplimab and ASP-1929 PIT.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04305795","url":"https://clinicaltrials.gov/study/NCT04305795"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","cutaneous-scc"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","cemiplimab"],"companies":["rakuten-medical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04305795","phase":"1/2","setting":"An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors","sponsor":"Rakuten Medical, Inc.","started":"2020-12-21","startedType":"actual","enrolled":23,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07359066","kind":"trial","name":"An Open-label, First-in-Human, Dose-Escalation and Dose-Expansion Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPR1020 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SRP1020 in advanced solid tumours, run by Shanghai SciBrunch Therapeutics Co., Ltd., now recruiting.","summary":"An Open-label, First-in-Human, Dose-Escalation and Dose-Expansion Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPR1020 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07359066 by Shanghai SciBrunch Therapeutics Co., Ltd., with 210 participants planned, started 2026-01-08 and due to reach its primary completion in 2028-02. Interventions recorded: SRP1020.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07359066","url":"https://clinicaltrials.gov/study/NCT07359066"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07359066","phase":"1/2","setting":"An Open-label, First-in-Human, Dose-Escalation and Dose-Expansion Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPR1020 in Patients With Advanced Solid Tumors","sponsor":"Shanghai SciBrunch Therapeutics Co., Ltd.","started":"2026-01-08","startedType":"actual","enrolled":210,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07806058","kind":"trial","name":"An Open-Label, Multicenter, Phase IB/II Clinical Study of HRS-7172 in Combination With Antitumor Therapy in Participants With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of adebrelimab in pancreatic cancer, run by Jiangsu HengRui Medicine Co., Ltd., not yet recruiting.","summary":"An Open-Label, Multicenter, Phase IB/II Clinical Study of HRS-7172 in Combination With Antitumor Therapy in Participants With Solid Tumors is a phase 1/2, randomised interventional study registered as NCT07806058 by Jiangsu HengRui Medicine Co., Ltd., with a registry enrolment figure of 140 participants, started 2026-09 and due to reach its primary completion in 2028-12-31. Interventions recorded: HRS-7172 + AG + SHR-1316; HRS-7172 + AG + SHR-1316;; HRS-7172 + AG;; HRS-7172 + AG + SHR-1316;; HRS-717 + HRS-4642+SHR-1316;; HRS-717 + HRS-4642+SHR-1316;; HRS-717 + HRS-4642;; HRS-717 + HRS-4642+SHR-1316;. Conditions listed: Pancreatic Cancer. Primary outcome: RDE in advanced pancreatic cancer with RAS mutation or amplification; Incidence and severity of adverse events (AEs) (per NCI-CTCAE V6.0 criteria); ORR assessed by the investigator. Pancreatic eligibility wording from the registry: \"Locally advanced or metastatic pancreatic cancer confirmed by histology and cytology, with RAS mutation/amplification detected by tissue or blood genetic testing\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07806058","url":"https://clinicaltrials.gov/study/NCT07806058"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07806058","phase":"1/2","setting":"An Open-Label, Multicenter, Phase IB/II Clinical Study of the Safety, Tolerability, and Efficacy of HRS-7172 in Combination With Antitumor Therapy in Participants With Solid Tumors","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2026-09","startedType":"estimated","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07589569","kind":"trial","name":"An Open-label, Multicenter, Phase II Clinical Study to Evaluate HRS-7058 in Patients With Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of HRS-7058 in pancreatic ductal adenocarcinoma, run by Shandong Suncadia Medicine Co., Ltd., now recruiting.","summary":"An Open-label, Multicenter, Phase II Clinical Study to Evaluate HRS-7058 in Patients With Pancreatic Cancer is a phase 2 interventional study registered as NCT07589569 by Shandong Suncadia Medicine Co., Ltd., with 92 participants planned, started 2026-06-04 and due to reach its primary completion in 2028-12. Interventions recorded: HRS-7058.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07589569","url":"https://clinicaltrials.gov/study/NCT07589569"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac","kras-g12c-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07589569","phase":"2","setting":"An Open, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-7058 in Patients With Locally Advanced or Metastatic Pancreatic Cancer Harboring KRAS G12C Mutations Who Have Failed Prior Systemic Therapy.","sponsor":"Shandong Suncadia Medicine Co., Ltd.","started":"2026-06-04","startedType":"actual","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02213926","kind":"trial","name":"An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma","aka":[],"tldr":"A phase 2 trial of Acalabrutinib in mantle cell lymphoma, run by Acerta Pharma BV, active and no longer recruiting.","summary":"An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma is a phase 2 interventional study registered as NCT02213926 by Acerta Pharma BV, with 124 participants enrolled, started 2015-03-02 and due to reach its primary completion in 2020-12-04. Interventions recorded: ACP-196 (acalabrutinib). Conditions listed: Mantle Cell Lymphoma (MCL). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02213926","url":"https://clinicaltrials.gov/study/NCT02213926"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["acalabrutinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02213926","phase":"2","setting":"An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma","sponsor":"Acerta Pharma BV","started":"2015-03-02","startedType":"actual","enrolled":124,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02180724","kind":"trial","name":"An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia","aka":[],"tldr":"A phase 2 trial of Acalabrutinib in waldenström macroglobulinaemia, run by Acerta Pharma BV, active and no longer recruiting.","summary":"An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia is a phase 2 interventional study registered as NCT02180724 by Acerta Pharma BV, with 107 participants enrolled, started 2014-09-11 and due to reach its primary completion in 2019-10-01. Interventions recorded: Acalabrutinib (ACP-196). Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02180724","url":"https://clinicaltrials.gov/study/NCT02180724"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["waldenstrom"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["acalabrutinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02180724","phase":"2","setting":"An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia","sponsor":"Acerta Pharma BV","started":"2014-09-11","startedType":"actual","yearReported":2020,"enrolled":107,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria, ORR 6th IWWM criteria (CR+VGPR+PR+MR)","primary":true,"unit":"participants","arms":[{"name":"Previously Treated (N=92)","n":92,"value":87,"note":"Figures from the ClinicalTrials.gov results section (first posted 2020-04-24), not from a publication"},{"name":"Treatment Naive (N=14)","n":14,"value":13}],"source":"https://clinicaltrials.gov/study/NCT02180724?tab=results"},{"endpoint":"Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 3rd Criteria, ORR 3rd IWWM criteria (CR+VGPR+PR+MR)","primary":true,"unit":"participants","arms":[{"name":"Previously Treated (N=92)","n":92,"value":87,"note":"Figures from the ClinicalTrials.gov results section (first posted 2020-04-24), not from a publication"},{"name":"Treatment Naive (N=14)","n":14,"value":13}],"source":"https://clinicaltrials.gov/study/NCT02180724?tab=results"}]},{"id":"nct07668453","kind":"trial","name":"An Open-label, Single-arm, Multicenter Exploratory Study of Adebrelimab Combined With Gemcitabine and Albumin-bound Paclitaxel as First-line Treatment for Biliary Tract Malignancies","aka":[],"tldr":"A phase 2 trial of adebrelimab, gemcitabine and nab-paclitaxel in gallbladder cancer and other biliary tract cancers, run by The First Affiliated Hospital with Nanjing Medical University, now recruiting.","summary":"An Open-label, Single-arm, Multicenter Exploratory Study of Adebrelimab Combined With Gemcitabine and Albumin-bound Paclitaxel as First-line Treatment for Biliary Tract Malignancies is a phase 2 interventional study registered as NCT07668453 by The First Affiliated Hospital with Nanjing Medical University, with a registry enrolment figure of 30 participants, started 2025-10-20 and due to reach its primary completion in 2027-06-30. Interventions recorded: Adebrelimab, gemcitabine, Albumin-Bound Paclitaxel /nab-Paclitaxel. Conditions listed: Biliary Tract Neoplasms. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07668453","url":"https://clinicaltrials.gov/study/NCT07668453"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["adebrelimab","gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07668453","phase":"2","setting":"An Open-label, Single-arm, Multicenter Exploratory Study of Adebrelimab Combined With Gemcitabine and Albumin-bound Paclitaxel as First-line Treatment for Biliary Tract Malignancies","sponsor":"The First Affiliated Hospital with Nanjing Medical University","started":"2025-10-20","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06855849","kind":"trial","name":"An Open-label, Single-arm, Multicenter Phase II Study to Evaluate the Efficacy of Amivantamab in Combination With FOLFIRI as a Second-line Treatment in Patients","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Yonsei University, not yet recruiting.","summary":"An Open-label, Single-arm, Multicenter Phase II Study to Evaluate the Efficacy of Amivantamab in Combination With FOLFIRI as a Second-line Treatment in Patients With RAS/BRAF Wild-type Advanced Colorectal Cancer Progressing on Prior Anti-EGFR Based Treatment. is a phase 2, interventional study registered as NCT06855849 by Yonsei University, with a registry enrolment figure of 85 participants, started 2025-05 and due to reach its primary completion in 2027-05. Interventions recorded: Amivantamab + FOLFIRI. Conditions listed: RAS/BRAF Wild-type Advanced Colorectal Cancer Patients. Primary outcome: Overall Response Rate. Colorectal eligibility wording from the registry: \"The participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06855849","url":"https://clinicaltrials.gov/study/NCT06855849"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06855849","phase":"2","setting":"An Open-label, Single-arm, Multicenter Phase II Study to Evaluate the Efficacy of Amivantamab in Combination With FOLFIRI as a Second-line Treatment in Patients With RAS/BRAF Wild-type Advanced Colorectal Cancer Progressing on Prior Anti-EGFR Based Treatment.","sponsor":"Yonsei University","started":"2025-05","startedType":"estimated","enrolled":85,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07371663","kind":"trial","name":"An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of TCC1727 tablet 90mg in non-small-cell lung cancer, gastric & gastro-oesophageal junction cancer, endometrial cancer and melanoma, run by Beijing Tide Pharmaceutical Co., Ltd, now recruiting.","summary":"An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07371663 by Beijing Tide Pharmaceutical Co., Ltd, with 266 participants planned, started 2025-12-03 and due to reach its primary completion in 2028-09-30. Interventions recorded: TCC1727 tablet 90mg, TCC1727 tablet 120mg, TCC1727 tablet 160mg and benmelstobart Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07371663","url":"https://clinicaltrials.gov/study/NCT07371663"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","gastric","endometrial","melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["benmelstobart"],"companies":["beijing-tide-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07371663","phase":"1/2","setting":"An Open-Label, Multicenter Phase Ib/II Clinical Trial of TCC1727 in Combination With Benmelstobart/Olaparib/Topotecan for Advanced Solid Tumors","sponsor":"Beijing Tide Pharmaceutical Co., Ltd","started":"2025-12-03","startedType":"actual","enrolled":266,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00532194","kind":"trial","name":"An RCT of Concurrent and Maintenance Cediranib in Women With Platinum-sensitive Relapsed Ovarian Cancer","aka":["ICON6"],"tldr":"A phase 3 trial of Cediranib in Ovarian cancer, run by Medical Research Council, with a status the registry has not verified recently.","summary":"An RCT of Concurrent and Maintenance Cediranib in Women With Platinum-sensitive Relapsed Ovarian Cancer is a phase 3 interventional study registered as NCT00532194 by Medical Research Council, with 486 participants planned, started 2007-07 and due to reach its primary completion in 2013-04. Interventions recorded: cediranib. Conditions recorded: Ovarian Cancer.\n\nLinked to the drug Cediranib because the registry names it among its interventions and Ovarian cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00532194","url":"https://clinicaltrials.gov/study/NCT00532194"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cediranib"],"companies":["mrc-ctu"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00532194","phase":"3","setting":"A Randomised, Placebo-controlled, Trial of Concurrent Cediranib [AZD2171] (With Platinum-based Chemotherapy) and Concurrent and Maintenance Cediranib in Women With Platinum-sensitive Relapsed Ovarian Cancer","sponsor":"Medical Research Council","started":"2007-07","enrolled":486,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03637816","kind":"trial","name":"Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2/3 trial in lung cancer, run by M.D. Anderson Cancer Center, active but no longer recruiting.","summary":"Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer is a phase 2/3, randomised interventional study registered as NCT03637816 by M.D. Anderson Cancer Center, with a registry enrolment figure of 25 participants, started 2018-11-27 and due to reach its primary completion in 2026-12-31. Interventions recorded: Anamorelin Hydrochloride; Placebo; Questionnaire Administration. Conditions listed: Anorexia; Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer. Primary outcome: To reach thematic saturation by qualitatively examining experiences related to anorexia at the baseline in advanced lung cancer patients with anorexia/cachexia receiving either oral Anamorelin 100 mg or placebo.. Lung eligibility wording from the registry: \"* Patients with a diagnosis of advanced non-small cell lung cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03637816","url":"https://clinicaltrials.gov/study/NCT03637816"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03637816","phase":"2/3","setting":"Qualitative Study on Experiences Related to Anorexia and the Effects of Anamorelin and Placebo in Advanced Non-Small-Cell Lung Cancer Patients With Anorexia-Cachexia: A Preliminary Study","sponsor":"M.D. Anderson Cancer Center","started":"2018-11-27","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"anbl0531","kind":"trial","name":"ANBL0531","aka":["COG ANBL0531"],"tldr":"ANBL0531 showed that children with intermediate-risk neuroblastoma can be cured almost every time with a treatment plan that gives less chemotherapy to those with favourable tumour biology and a good early response, keeping three-year survival at 95 percent while cutting treatment for many.","summary":"ANBL0531 was the Children's Oncology Group phase 3 study for intermediate-risk neuroblastoma, enrolling 464 patients (404 evaluable) between 2007 and 2011. Treatment intensity was assigned by tumour biology (histology, MYCN, ploidy, 1p and 11q status) and response, with two to eight cycles of carboplatin, etoposide, cyclophosphamide and doxorubicin, surgery when resectable, isotretinoin for the highest-risk subset, and observation alone for some infants with stage 4S disease. The primary endpoint was three-year overall survival.\n\nThree-year event-free and overall survival were 83.2 and 94.9 percent, with overall survival of 100 percent for localised disease, despite reduced treatment for many subsets compared with earlier studies; the registry results give three-year overall survival of 99.4 percent in the lowest-intensity group and 88.4 percent in the highest. Infants with stage 4 disease and unfavourable biology did worse (three-year event-free survival 66.8 against 86.9 percent). The corpus's intermediate-risk neuroblastoma page cites ANBL0531 with A3961 for chemotherapy tailored by biology and response.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00499616","url":"https://clinicaltrials.gov/study/NCT00499616"}],"tags":["soc-trials"],"related":[],"cancers":["neuroblastoma-intermediate-risk","neuroblastoma","childhood-cancers"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["carboplatin","etoposide","cyclophosphamide","doxorubicin","topotecan","isotretinoin"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-anbl0531-twist-jco-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00499616","phase":"3","setting":"Intermediate-risk neuroblastoma: response- and biology-based assignment to two, four or eight cycles of carboplatin, etoposide, cyclophosphamide and doxorubicin (with topotecan for poor responders) and surgery, with isotretinoin for the highest-risk subset and no chemotherapy for some stage 4S infants","sponsor":"Children's Oncology Group","result":"Three-year event-free survival 83.2 percent and overall survival 94.9 percent with response- and biology-based reduction of chemotherapy; overall survival 100 percent for localised disease.","started":"2007-10-08","startedType":"actual","yearReported":2019,"enrolled":464,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 3 years, all evaluable patients","primary":true,"unit":"%","arms":[{"name":"Response- and biology-based therapy","n":404,"value":94.9,"note":"95% CI 92.7 to 97.2"}],"source":"https://doi.org/10.1200/JCO.19.00919"},{"endpoint":"Event-free survival at 3 years, all evaluable patients","unit":"%","arms":[{"name":"Response- and biology-based therapy","n":404,"value":83.2,"note":"95% CI 79.4 to 87.0"}],"source":"https://doi.org/10.1200/JCO.19.00919"},{"endpoint":"Event-free survival at 3 years, infants with stage 4 disease by biology","unit":"%","arms":[{"name":"Favourable biology","n":61,"value":86.9},{"name":"One or more unfavourable biological features","n":47,"value":66.8}],"p":"0.02","source":"https://doi.org/10.1200/JCO.19.00919"},{"endpoint":"Overall survival at 3 years by treatment group (registry results)","primary":true,"unit":"%","arms":[{"name":"Group 2 (two cycles, surgery)","value":99.4},{"name":"Group 3 (four cycles, surgery)","value":93.5},{"name":"Group 4 (eight cycles, surgery, isotretinoin)","value":88.4}],"source":"https://clinicaltrials.gov/study/NCT00499616?tab=results"}]},{"id":"anbl1221","kind":"trial","name":"ANBL1221","aka":["COG ANBL1221"],"tldr":"ANBL1221 found that adding the anti-GD2 antibody dinutuximab to irinotecan and temozolomide shrank relapsed neuroblastoma in about half of children, while adding temsirolimus almost never did, and chemo-immunotherapy became the standard salvage treatment.","summary":"ANBL1221 was a Children's Oncology Group randomised phase 2 selection trial for children with relapsed, refractory or progressive neuroblastoma. Patients received irinotecan and temozolomide with either temsirolimus or dinutuximab plus sargramostim (GM-CSF); the primary endpoint was the objective response rate over the first six cycles. After the randomised part chose dinutuximab, a further 36 patients were enrolled to that arm.\n\nOne of 18 patients responded with temsirolimus against 9 of 17 (52.9 percent) with dinutuximab; in all 53 patients treated with irinotecan, temozolomide, dinutuximab and GM-CSF the objective response rate was 41.5 percent with one-year progression-free survival of 67.9 percent and overall survival of 84.9 percent. Pain, fever and infection, neutropenia and hypokalaemia were the common grade 3 or higher toxicities. The regimen is the standard chemo-immunotherapy for relapsed neuroblastoma on the corpus's high-risk neuroblastoma page and was moved into first-line induction in ANBL17P1.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01767194","url":"https://clinicaltrials.gov/study/NCT01767194"}],"tags":["soc-trials"],"related":[],"cancers":["neuroblastoma-high-risk","neuroblastoma","childhood-cancers"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["irinotecan","temozolomide","dinutuximab","temsirolimus","sargramostim"],"companies":["united-therapeutics","childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-anbl1221-irinotecan-temozolomide-dinutuximab-mody-lancet-oncol-2017","paper-anbl1221-expansion-dinutuximab-gm-csf-mody-jco-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01767194","phase":"2","setting":"Children with relapsed, refractory or progressive neuroblastoma: irinotecan and temozolomide with either temsirolimus or the anti-GD2 antibody dinutuximab plus GM-CSF, randomised, then a non-randomised expansion of the dinutuximab arm","sponsor":"National Cancer Institute (NCI)","result":"Objective response 52.9 percent with irinotecan, temozolomide and dinutuximab against 5.6 percent with temsirolimus in the randomised part; 41.5 percent across all 53 dinutuximab-treated patients with one-year overall survival of 84.9 percent.","started":"2013-02-12","startedType":"actual","yearReported":2017,"enrolled":73,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response over the first 6 cycles, randomised patients","primary":true,"unit":"%","arms":[{"name":"Irinotecan + temozolomide + dinutuximab + GM-CSF","n":17,"value":52.9,"note":"95% CI 29.2 to 76.7; 4 partial and 5 complete responses"},{"name":"Irinotecan + temozolomide + temsirolimus","n":18,"value":5.6,"note":"95% CI 0.0 to 16.1"}],"source":"https://doi.org/10.1016/S1470-2045(17)30355-8"},{"endpoint":"Objective response, all patients given dinutuximab (randomised and expansion)","primary":true,"unit":"%","arms":[{"name":"Irinotecan + temozolomide + dinutuximab + GM-CSF","n":53,"value":41.5,"note":"95% CI 28.2 to 54.8; stable disease in a further 22 of 53"}],"source":"https://doi.org/10.1200/JCO.20.00203"},{"endpoint":"Progression-free survival at 1 year, all dinutuximab patients","unit":"%","arms":[{"name":"Irinotecan + temozolomide + dinutuximab + GM-CSF","n":53,"value":67.9}],"source":"https://doi.org/10.1200/JCO.20.00203"},{"endpoint":"Overall survival at 1 year, all dinutuximab patients","unit":"%","arms":[{"name":"Irinotecan + temozolomide + dinutuximab + GM-CSF","n":53,"value":84.9}],"source":"https://doi.org/10.1200/JCO.20.00203"}]},{"id":"anbl17p1","kind":"trial","name":"ANBL17P1","aka":["COG ANBL17P1"],"tldr":"ANBL17P1 tested whether the antibody dinutuximab, which works against relapsed neuroblastoma, can be given from the very start of treatment alongside induction chemotherapy for newly diagnosed high-risk disease; none of the 42 children had unacceptable toxicity, which opened the way to the randomised trial now under way.","summary":"ANBL17P1 was a Children's Oncology Group single-arm pilot study in 42 children with newly diagnosed high-risk neuroblastoma. Dinutuximab and sargramostim (GM-CSF) were added to cycles 3 to 5 of the standard induction chemotherapy (cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, doxorubicin), followed by surgery, tandem autologous transplant, radiotherapy and post-consolidation immunotherapy. The primary endpoints were the percentage of patients with unacceptable toxicity and the percentage who were feasibility failures over the first five cycles.\n\nIn the registry results neither endpoint recorded a single patient (0 percent for both). The regimen carried into the randomised phase 3 ANBL1531 amendment testing dinutuximab in induction, and the corpus's neuroblastoma page cites ANBL17P1 for adding dinutuximab to induction.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03786783","url":"https://clinicaltrials.gov/study/NCT03786783"},{"label":"ClinicalTrials.gov results","url":"https://clinicaltrials.gov/study/NCT03786783?tab=results"}],"tags":["soc-trials"],"related":[],"cancers":["neuroblastoma-high-risk","neuroblastoma","childhood-cancers"],"sections":[],"technologies":["cytotoxic-chemotherapy","autologous-stem-cell-transplant"],"targets":[],"drugs":["dinutuximab","sargramostim","cyclophosphamide","topotecan","cisplatin","etoposide","vincristine","doxorubicin"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03786783","phase":"2","setting":"Newly diagnosed high-risk neuroblastoma: a pilot induction regimen adding the anti-GD2 antibody dinutuximab and GM-CSF to the standard five-cycle chemotherapy induction, followed by tandem transplant and radiotherapy, with unacceptable toxicity and feasibility as the primary endpoints","sponsor":"National Cancer Institute (NCI)","result":"No patient had unacceptable toxicity and none was a feasibility failure over the first five induction cycles with dinutuximab and GM-CSF added.","started":"2019-03-04","startedType":"actual","yearReported":2023,"enrolled":42,"enrolledBasis":"registry","outcomes":[{"endpoint":"Unacceptable toxicity over the first 5 cycles (registry results)","primary":true,"unit":"%","arms":[{"name":"Induction chemotherapy + dinutuximab + GM-CSF","n":42,"value":0}],"source":"https://clinicaltrials.gov/study/NCT03786783?tab=results"},{"endpoint":"Feasibility failure over the first 5 cycles (registry results)","primary":true,"unit":"%","arms":[{"name":"Induction chemotherapy + dinutuximab + GM-CSF","n":42,"value":0}],"source":"https://clinicaltrials.gov/study/NCT03786783?tab=results"}]},{"id":"anchor","kind":"trial","name":"ANCHOR","aka":["ANCHOR study","Anal Cancer/HSIL Outcomes Research","AMC-A01"],"tldr":"ANCHOR proved for the first time that treating precancerous anal lesions in people with HIV prevents anal cancer: those whose lesions were removed or ablated were 57 percent less likely to develop cancer than those who were simply monitored, which is the evidence behind screening and treating these lesions.","summary":"ANCHOR was a phase 3 trial of the AIDS Malignancy Consortium that screened more than 10,000 people living with HIV and randomised 4,459 with biopsy-proven anal high-grade squamous intraepithelial lesions to treatment or active monitoring. Treatment was mostly office-based infrared coagulation, hyfrecation or laser ablation, with topical fluorouracil or imiquimod or surgical excision as alternatives; monitoring was high-resolution anoscopy every six months with biopsy of suspected cancer. The primary endpoint was time to progression to anal cancer.\n\nThe monitoring committee stopped the trial early for efficacy. At a median follow-up of 25.8 months, nine cancers were diagnosed in the treatment group (173 per 100,000 person-years) and 21 in the monitoring group (402 per 100,000 person-years), a 57 percent reduction. The result led the United States guidelines to recommend anal cancer screening and treatment of high-grade lesions in people with HIV, which is how the corpus's anal cancer precursor page cites it.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02135419","url":"https://clinicaltrials.gov/study/NCT02135419"}],"tags":["soc-trials"],"related":[],"cancers":["anal-hsil-precursor","anal"],"sections":[],"technologies":["active-surveillance","thermal-ablation"],"targets":[],"drugs":["fluorouracil","imiquimod"],"companies":["aids-malignancy-consortium"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-anchor-anal-hsil-treatment-nejm-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02135419","phase":"3","setting":"People living with HIV aged 35 or older with biopsy-proven anal high-grade squamous intraepithelial lesions at 25 US sites: treatment of the lesions (mainly office-based ablation, with topical fluorouracil or imiquimod or excision) against active monitoring every six months, with progression to anal cancer as the primary endpoint","sponsor":"AIDS Malignancy Consortium","result":"Progression to anal cancer 173 per 100,000 person-years with treatment against 402 with active monitoring, a 57 percent reduction (95% CI 6 to 80, p 0.03); the trial stopped early for efficacy.","started":"2014-09-24","startedType":"actual","yearReported":2022,"enrolled":4446,"enrolledBasis":"analysed","enrolledNote":"The registry counts 4,446 participants; 4,459 were randomised and 4,446 (99.7 percent) analysed for time to progression to cancer in the New England Journal of Medicine report.","outcomes":[{"endpoint":"Incidence of anal cancer","primary":true,"unit":"cases per 100,000 person-years","arms":[{"name":"Treatment of high-grade lesions","value":173,"note":"9 cases; 95% CI 90 to 332; median follow-up 25.8 months"},{"name":"Active monitoring","value":402,"note":"21 cases; 95% CI 262 to 616"}],"p":"0.03","source":"https://doi.org/10.1056/NEJMoa2201048"},{"endpoint":"Reduction in the rate of progression to anal cancer with treatment","unit":"%","arms":[{"name":"Treatment against active monitoring","value":57,"note":"95% CI 6 to 80"}],"source":"https://doi.org/10.1056/NEJMoa2201048"}]},{"id":"nct07336732","kind":"trial","name":"Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations","aka":["KANNON-5"],"tldr":"A phase 2 trial of PLB1004 in non-small-cell lung cancer, run by Avistone Biotechnology Co., Ltd., now recruiting.","summary":"Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations is a phase 2 interventional study registered as NCT07336732 by Avistone Biotechnology Co., Ltd., with 40 participants planned, started 2026-03-11 and due to reach its primary completion in 2026-11. Interventions recorded: PLB1004.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07336732","url":"https://clinicaltrials.gov/study/NCT07336732"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["avistone-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07336732","phase":"2","setting":"An Open-label, Randomized, Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harboring Atypical EGFR Mutations Who Have Not Received Prior Systematic Therapy","sponsor":"Avistone Biotechnology Co., Ltd.","started":"2026-03-11","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"anetumab-vs-vinorelbine-mpm","kind":"trial","name":"Anetumab ravtansine versus vinorelbine in relapsed mesothelin-positive pleural mesothelioma","aka":[],"tldr":"The first randomised test of an antibody-drug conjugate in mesothelioma: no better than vinorelbine, which is why no ADC is approved for this cancer.","summary":"589 patients were screened and 248 with mesothelin over-expression were randomised 2:1 to anetumab ravtansine or vinorelbine. Median progression-free survival was 4.3 months with the conjugate and 4.5 months with vinorelbine (hazard ratio 1.22, 95% CI 0.85 to 1.74). Grade 3 or worse neutropenia was rare with anetumab ravtansine (1% versus 39%), but serious adverse events and treatment-emergent deaths occurred in both arms. Kindler and colleagues reported it in Lancet Oncology in 2022.","status":"negative","asOf":"2026-09-11","links":[{"label":"Lancet Oncology 2022","url":"https://doi.org/10.1016/S1470-2045(22)00061-4"},{"label":"ClinicalTrials.gov NCT02610140","url":"https://clinicaltrials.gov/study/NCT02610140"}],"tags":["owner-request"],"related":[],"cancers":["mesothelioma"],"sections":[],"technologies":["adc"],"targets":["mesothelin"],"drugs":["anetumab-ravtansine","vinorelbine"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-kindler-lancet-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02610140","phase":"2","setting":"Second-line, unresectable locally advanced or metastatic malignant pleural mesothelioma over-expressing mesothelin after platinum and pemetrexed, randomised open-label at 76 hospitals in 14 countries","sponsor":"Bayer","result":"PFS 4.3 vs 4.5 months, HR 1.22; primary endpoint not met.","started":"2015-12-03","startedType":"actual","yearReported":2022,"enrolled":248,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Anetumab ravtansine","n":166,"value":4.3},{"name":"Vinorelbine","n":82,"value":4.5}],"hr":1.22,"ci":[0.85,1.74],"source":"https://doi.org/10.1016/S1470-2045(22)00061-4"}]},{"id":"angiotax","kind":"trial","name":"ANGIOTAX","aka":[],"tldr":"A small French trial showed weekly paclitaxel controls angiosarcoma in most patients for a few months, making it the standard drug for this rare vascular cancer.","summary":"ANGIOTAX was a single-arm phase 2 trial of the French Sarcoma Group in which 30 patients with unresectable or metastatic angiosarcoma received weekly paclitaxel 80 mg/m2. Most patients were free of progression at two months, the primary endpoint, with responses concentrated in cutaneous scalp and face angiosarcoma, and toxicity was mild. Published in the Journal of Clinical Oncology in 2008, it made weekly paclitaxel the reference systemic treatment for angiosarcoma; the successor ANGIOTAX-PLUS trial found that adding bevacizumab did not improve outcomes.","status":"completed","asOf":"2026-09-17","links":[{"label":"Journal of Clinical Oncology 2008","url":"https://doi.org/10.1200/JCO.2008.17.3146"}],"tags":["subtype-page"],"related":[],"cancers":["angiosarcoma","vascular-tumours","sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["paclitaxel"],"companies":["french-sarcoma-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"2","setting":"Unresectable or metastatic angiosarcoma: weekly paclitaxel","sponsor":"French Sarcoma Group","result":"Primary endpoint met: most patients progression-free at two months; responses mainly in cutaneous scalp and face disease.","yearReported":2008,"enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"anita","kind":"trial","name":"ANITA (Adjuvant Navelbine International Trialist Association)","aka":["ANITA trial"],"tldr":"Confirmed that chemotherapy after lung cancer surgery adds about two years to median survival, with the benefit lasting at least seven years.","summary":"ANITA randomised 840 patients with completely resected stage IB to IIIA non-small-cell lung cancer from 101 centres in 14 countries to observation (433) or to vinorelbine 30 mg/m2 with cisplatin 100 mg/m2 (407). Postoperative radiotherapy was not mandated and followed each centre's policy. Thirty-six percent had stage IB disease, 24 percent stage II and 39 percent stage IIIA.\n\nAfter a median 76 months, median survival was 65.7 months with chemotherapy against 43.7 months with observation, and the adjusted hazard ratio for death was 0.80 (95 percent confidence interval 0.66 to 0.96, p=0.017). Five-year overall survival improved by 8.6 percent and the gain was maintained at seven years (8.4 percent).\n\nTolerance was the limiting factor: neutropenia in 92 percent, febrile neutropenia in 9 percent and seven toxic deaths (2 percent), with compliance far better for cisplatin (median dose intensity 89 percent) than for vinorelbine (59 percent). A retrospective subgroup suggested postoperative radiotherapy helped N2 patients, a hypothesis Lung ART later tested and refuted.","status":"positive","asOf":"2026-09-25","links":[{"label":"ANITA (Lancet Oncology 2006)","url":"https://doi.org/10.1016/S1470-2045(06)70804-X"},{"label":"ISRCTN95053737","url":"https://www.isrctn.com/ISRCTN95053737"}],"tags":[],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["vinorelbine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["ialt","jbr-10","lace-pooled-analysis","lung-art"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN95053737","phase":"3","setting":"Completely resected stage IB to IIIA non-small-cell lung cancer: vinorelbine 30 mg/m2 with cisplatin 100 mg/m2 versus observation, with overall survival as the primary endpoint","sponsor":"Adjuvant Navelbine International Trialist Association","result":"Median survival 65.7 against 43.7 months (hazard ratio 0.80); five-year overall survival improved by 8.6 percent.","yearReported":2006,"enrolled":840,"enrolledBasis":"randomised","enrolledNote":"840 patients were randomised across 101 centres in 14 countries; the trial is registered as ISRCTN95053737, not on ClinicalTrials.gov.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Vinorelbine and cisplatin","n":407,"value":65.7},{"name":"Observation","n":433,"value":43.7}],"hr":0.8,"ci":[0.66,0.96],"p":"0.017","source":"https://doi.org/10.1016/S1470-2045(06)70804-X"}],"replication":"Consistent with IALT and JBR.10; pooled in the LACE analysis."},{"id":"nct07398326","kind":"trial","name":"Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of anlotinib and sintilimab in colorectal cancer, run by Shanghai Changzheng Hospital, now recruiting.","summary":"Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT07398326 by Shanghai Changzheng Hospital, with a registry enrolment figure of 37 participants, started 2026-02-24 and due to reach its primary completion in 2027-12-31. Interventions recorded: anlotinib and sintilimab. Conditions listed: Colorectal Cancer. Primary outcome: Objective response rate. Colorectal eligibility wording from the registry: \"* Patients with histologically or cytologically confirmed advanced colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07398326","url":"https://clinicaltrials.gov/study/NCT07398326"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["anlotinib","sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07398326","phase":"2","setting":"Phase II Study of Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer","sponsor":"Shanghai Changzheng Hospital","started":"2026-02-24","startedType":"estimated","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05862337","kind":"trial","name":"Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.","aka":[],"tldr":"A phase 3 trial of Anlotinib, Penpulimab in hepatocellular carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., now recruiting.","summary":"Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence. is a phase 3 interventional study registered as NCT05862337 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with 480 participants planned, started 2023-05-10 and due to reach its primary completion in 2024-08. Interventions recorded: Anlotinib hydrochloride capsules, Penpulimab injection, Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05862337","url":"https://clinicaltrials.gov/study/NCT05862337"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-early"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["anlotinib","penpulimab"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05862337","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study of Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection in Patients With High Risk of Relapse After Radical Surgery or Ablation of Hepatocellular Carcinoma (HCC).","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2023-05-10","startedType":"actual","enrolled":480,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06621095","kind":"trial","name":"Anlotinib Plus Benmelstobart and AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer (ALTER-PA-001)","aka":["ALTER-PA-001"],"tldr":"A phase 2 trial of gemcitabine + nab-paclitaxel in pancreatic cancer, run by RenJi Hospital, not yet recruiting.","summary":"Anlotinib Plus Benmelstobart and AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer (ALTER-PA-001) is a phase 2, randomised interventional study registered as NCT06621095 by RenJi Hospital, with a registry enrolment figure of 104 participants, started 2024-10-30 and due to reach its primary completion in 2025-12-31. Interventions recorded: anlotinib + benmelstobart + nab-paclitaxel + gemcitabine; nab-paclitaxel + gemcitabine. Conditions listed: Pancreatic Cancer; First-line; Metastatic Pancreatic Cancer. Primary outcome: Objective response rate (ORR). Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed diagnosis of metastatic pancreatic cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06621095","url":"https://clinicaltrials.gov/study/NCT06621095"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06621095","phase":"2","setting":"Anlotinib Plus Benmelstobart and AG Versus AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer: a Prospective, Randomized Controlled Clinical Trial (ALTER-PA-001)","sponsor":"RenJi Hospital","started":"2024-10-30","startedType":"estimated","enrolled":104,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04322617","kind":"trial","name":"Anlotinib Plus Immune Checkpoint Inhibitors for Lung Cancer","aka":["ATHENA"],"tldr":"A phase 2/3 trial of anlotinib in lung cancer, run by Hunan Province Tumor Hospital, now recruiting.","summary":"Anlotinib Plus Immune Checkpoint Inhibitors for Lung Cancer is a phase 2/3, interventional study registered as NCT04322617 by Hunan Province Tumor Hospital, with a registry enrolment figure of 1200 participants, started 2020-03-24 and due to reach its primary completion in 2028-03-24. Interventions recorded: Anlotinib plus the same Immune Checkpoint Inhibitors.; Anlotinib plus the new Immune Checkpoint Inhibitors.; Anlotinib. Conditions listed: Non-small Cell Lung Cancer. Primary outcome: Progression free survival time (PFS). Lung eligibility wording from the registry: \"Histopathology or cytology confirmed lung cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04322617","url":"https://clinicaltrials.gov/study/NCT04322617"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["anlotinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04322617","phase":"2/3","setting":"Anlotinib With or Without Immune Checkpoint Inhibitors in Standard Chemo-immunotherapy Failed Advanced Non-small Cell Lung Cancer","sponsor":"Hunan Province Tumor Hospital","started":"2020-03-24","startedType":"actual","enrolled":1200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06662877","kind":"trial","name":"Anlotinib Plus Nab-Paclitaxels and S-1 for Patients with Advanced Biliary Tract Cancer As Second-Line Treatment","aka":[],"tldr":"A phase 2/3 trial of oxaliplatin, fluorouracil, leucovorin and other drugs in gallbladder cancer and other biliary tract cancers, run by Sun Yat-sen University, not yet recruiting.","summary":"Anlotinib Plus Nab-Paclitaxels and S-1 for Patients with Advanced Biliary Tract Cancer As Second-Line Treatment is a phase 2/3, randomised interventional study registered as NCT06662877 by Sun Yat-sen University, with a registry enrolment figure of 206 participants, started 2024-11-25 and due to reach its primary completion in 2029-09-01. Interventions recorded: Albumin-bound Paclitaxel + Tegafur Gimeracil Oteracil (S-1) + Anlotinib, Oxaliplatin + Leucovorin + Fluorouracil (FOLFOX regimen). Conditions listed: Biliary Tract Cancer, Second Line Treatment, Chemotherapy, Tyrosine Kinase Inhibitor. Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06662877","url":"https://clinicaltrials.gov/study/NCT06662877"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","kinase-inhibitors"],"targets":[],"drugs":["oxaliplatin","fluorouracil","leucovorin","folfox","nab-paclitaxel","tegafur-gimeracil-oteracil","anlotinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06662877","phase":"2/3","setting":"Anlotinib Plus Nab-Paclitaxels and S-1 Versus FOLFOX for Patients with Advanced Biliary Tract Cancer As Second-Line Treatment: a Phase 2/3, Multi-centric Double-stage Randomized Controlled Trial","sponsor":"Sun Yat-sen University","started":"2024-11-25","startedType":"estimated","enrolled":206,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07443397","kind":"trial","name":"Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in SCLC Patients.","aka":[],"tldr":"A phase 3 trial of anlotinib in lung cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in SCLC Patients. is a phase 3, randomised interventional study registered as NCT07443397 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 134 participants, started 2025-08-29 and due to reach its primary completion in 2027-08-31. Interventions recorded: Anlotinib; Whole-brain Radiotherapy. Conditions listed: Whole-Brain Radiotherapy. Primary outcome: Intracranial progression-free survival. Lung eligibility wording from the registry: \"* Small cell lung cancer confirmed by pathology, with brain metastases diagnosed either at initial presentation or during treatment, and measurable disease according to RECIST criteria\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07443397","url":"https://clinicaltrials.gov/study/NCT07443397"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["antiangiogenic","imrt-igrt","kinase-inhibitors"],"targets":[],"drugs":["anlotinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07443397","phase":"3","setting":"Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in Small Cell Lung Cancer Patients: A Multicenter Phase III Trail.","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2025-08-29","startedType":"actual","enrolled":134,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07635290","kind":"trial","name":"Anlotinib+Cadonilimab+PULSAR in Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of cadonilimab and anlotinib in gallbladder cancer and other biliary tract cancers, run by West China Hospital, active and no longer recruiting.","summary":"Anlotinib+Cadonilimab+PULSAR in Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT07635290 by West China Hospital, with a registry enrolment figure of 26 participants, started 2026-06-03 and due to reach its primary completion in 2027-06-30. Interventions recorded: Anlotinib + Cadonilimab, PULSAR. Conditions listed: Previously Treated, Advanced, Biliary Tract Cancers. Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07635290","url":"https://clinicaltrials.gov/study/NCT07635290"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["cadonilimab","anlotinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07635290","phase":"2","setting":"A Phase II Clinical Trial of Anlotinib Combined With Cadonilimab and PULSAR in Previously Treated Advanced Unresectable or Metastatic Biliary Tract Cancer","sponsor":"West China Hospital","started":"2026-06-03","startedType":"actual","enrolled":26,"enrolledBasis":"registry","outcomes":[]},{"id":"announce","kind":"trial","name":"ANNOUNCE","aka":[],"tldr":"A PDGFRα antibody that had won accelerated approval on a small trial failed to improve survival in the confirmatory study and was withdrawn.","summary":"ANNOUNCE, trial NCT02451943 sponsored by Eli Lilly and published in JAMA in 2020, tested the PDGFR-alpha antibody olaratumab with doxorubicin against doxorubicin alone as first-line treatment for advanced soft-tissue sarcoma, and found no improvement in survival or progression, so a drug that had won accelerated approval on a small trial was withdrawn in 2019. It randomised 509 patients and showed no difference in overall survival, its primary endpoint. OnCo links it to sarcomas, doxorubicin and William D. Tap. The record treats it as a frequently cited lesson on phase 2 signals and accelerated approval, and why the earlier randomised phase 2 was so misleading remains the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02451943","url":"https://clinicaltrials.gov/study/NCT02451943"}],"tags":["lesson:accelerated-approval"],"related":[],"cancers":["sarcoma","extremity-soft-tissue-sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["doxorubicin","olaratumab"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["william-tap"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02451943","phase":"3","setting":"Advanced soft-tissue sarcoma, first line: olaratumab + doxorubicin vs doxorubicin","sponsor":"Eli Lilly","result":"OS HR 1.05 (negative); drug withdrawn.","started":"2015-09-14","startedType":"actual","yearReported":2019,"enrolled":509,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Olaratumab + doxorubicin","n":258,"value":20.4},{"name":"Doxorubicin","n":251,"value":19.7}],"hr":1.05,"ci":[0.84,1.3],"source":"https://jamanetwork.com/journals/jama/fullarticle/2763325"}]},{"id":"nct07444541","kind":"trial","name":"ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of Gemcitabine in pancreatic ductal adenocarcinoma, run by Anova Innovation Limited, now recruiting.","summary":"ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer is a phase 1/2 interventional study registered as NCT07444541 by Anova Innovation Limited, with 84 participants planned, started 2026-08 and due to reach its primary completion in 2027-08. Interventions recorded: ANO31905, Nanoparticle Albumin-Bound Paclitaxel and Gemcitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07444541","url":"https://clinicaltrials.gov/study/NCT07444541"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07444541","phase":"1/2","setting":"A Phase Ib/Ⅱ Clinical Study to Evaluate the Safety and Efficacy of ANO31905 for Injection in Combination With Chemotherapy as the First-line Treatment for Patients With CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer","sponsor":"Anova Innovation Limited","started":"2026-08","startedType":"estimated","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07537998","kind":"trial","name":"Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Co","aka":[],"tldr":"A phase 2/3 trial in colorectal cancer, run by Pei-Rong Ding, now recruiting.","summary":"Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial. is a phase 2/3, randomised interventional study registered as NCT07537998 by Pei-Rong Ding, with a registry enrolment figure of 160 participants, started 2026-04-10 and due to reach its primary completion in 2027-04-10. Interventions recorded: intestinal fluid infusion; potable water. Conditions listed: Low Anterior Resection Syndrome; Rectal Cancer. Primary outcome: LARS score(m1). Colorectal eligibility wording from the registry: \"* Patients with mid to low rectal cancer (within 10cm of the anal verge) who undergo radical DIXON+ileostomy surgery\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07537998","url":"https://clinicaltrials.gov/study/NCT07537998"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07537998","phase":"2/3","setting":"Antegrade Intestinal Fluid Reinfusion Verse Water Infusion Through Prophylactic Ileal Stoma for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial.","sponsor":"Pei-Rong Ding","started":"2026-04-10","startedType":"estimated","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05296564","kind":"trial","name":"Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers","aka":[],"tldr":"A phase 1/2 trial of cyclophosphamide and aldesleukin (high-dose il-2) in triple-negative breast cancer, run by Hadassah Medical Organization, now recruiting.","summary":"Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers is a phase 1/2, interventional study registered as NCT05296564 by Hadassah Medical Organization, with a registry enrolment figure of 3 participants, started 2022-04-01 and due to reach its primary completion in 2027-12-30. Interventions recorded: CYCLOPHOSPHAMIDE and FLUDARABIN; Cyclophosphamide; HBI 0201-ESO TCRT; Aldesleukin. Conditions listed: Sarcoma, Synovial; Sarcoma,Soft Tissue; Melanoma Stage IV; Triple Negative Breast Cancer; Metastatic Cancer; Non Small Cell Lung Cancer; Bladder Urothelial Carcinoma; Neuroblastoma, Metastatic; Ovary Cancer. Sites: Israel. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05296564","url":"https://clinicaltrials.gov/study/NCT05296564"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cyclophosphamide","aldesleukin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05296564","phase":"1/2","setting":"A Phase I/II Dose Escalation, Safety and Efficacy Study of Anti-NY-ESO-1 T Cell Receptor (TCR)-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers","sponsor":"Hadassah Medical Organization","started":"2022-04-01","startedType":"actual","enrolled":3,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07686796","kind":"trial","name":"Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR/ MSS Locally Advanced Rectal Cancer : A P","aka":[],"tldr":"A phase 3 trial of cAPOX (capecitabine, oxaliplatin) and sintilimab in colorectal cancer, run by Guangdong Provincial People's Hospital, not yet recruiting.","summary":"Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR/ MSS Locally Advanced Rectal Cancer : A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Trial is a phase 3, randomised interventional study registered as NCT07686796 by Guangdong Provincial People's Hospital, with a registry enrolment figure of 148 participants, started 2027-01-01 and due to reach its primary completion in 2030-01-01. Interventions recorded: Short-course radiotherapy; CAPOX (oxaliplatin/capecitabine); Sintilimab; Tafolecimab. Conditions listed: Local Advanced Rectal Cancer; PD-1 Inhibitor; PCSK9 Inhibitor; RCT; Radiotherapy; Capecitabine; Oxaliplatin. Primary outcome: Complete Response (CR) Rate; Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma, determined to be pMMR (proficient mismatch repair) or MSS (microsatellite stable) by immunohistochemistry and/or genetic testing; clinical stage cT3/T4 or cN+; distal tumor margin ≤ 12 cm from the anal verge; and eligible for surgical resection\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07686796","url":"https://clinicaltrials.gov/study/NCT07686796"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capox","sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07686796","phase":"3","setting":"Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR/ MSS Locally Advanced Rectal Cancer : A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Trial","sponsor":"Guangdong Provincial People's Hospital","started":"2027-01-01","startedType":"estimated","enrolled":148,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05841472","kind":"trial","name":"Anti-PD-1 Antibody Therapies of Camrelizumab in Combination With Pemetrexed and Carboplatin as First-line Treatment in Patients With Advanced or Metas","aka":[],"tldr":"A phase 2 trial of Camrelizumab, Pemetrexed, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by CrystalGenomics, Inc., now recruiting.","summary":"Anti-PD-1 Antibody Therapies of Camrelizumab in Combination With Pemetrexed and Carboplatin as First-line Treatment in Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT05841472 by CrystalGenomics, Inc., with 60 participants planned, started 2023-08-23 and due to reach its primary completion in 2026-08. Interventions recorded: Camrelizumab (SHR-1210), Pemetrexed, and Carboplatin. Conditions listed: Non Squamous Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05841472","url":"https://clinicaltrials.gov/study/NCT05841472"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["camrelizumab","pemetrexed","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05841472","phase":"2","setting":"An Open-label, Multi-center, Clinical Study to Evaluate Anti-PD-1 Antibody Therapies of Camrelizumab in Combination With Pemetrexed and Carboplatin as First-line Treatment in Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer","sponsor":"CrystalGenomics, Inc.","started":"2023-08-23","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05413850","kind":"trial","name":"Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection","aka":[],"tldr":"A phase 1/2 trial of FAP-2286 in prostate cancer, run by Blue Earth Therapeutics Ltd, now recruiting.","summary":"Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection is a phase 1/2 interventional study registered as NCT05413850 by Blue Earth Therapeutics Ltd, with 82 participants planned, started 2022-07-20 and due to reach its primary completion in 2026-08-27. Interventions recorded: Lutetium (177Lu) rhPSMA-10.1 Injection, 18F-rhPSMA-7.3 injection (in phase 1 only). Conditions listed: Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, mCRPC, Urogenital Neoplasms. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05413850","url":"https://clinicaltrials.gov/study/NCT05413850"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["fapi-pet","radioligand-therapy"],"targets":[],"drugs":["fap-2286"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05413850-j-nucl-med-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05413850","phase":"1/2","setting":"An Open-label, Multicentre, Integrated Phase 1 & 2 Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Anti-tumour Activity of Lutetium (177Lu) rhPSMA-10.1 Injection in Men With Metastatic Castrate-resistant Prostate Cancer","sponsor":"Blue Earth Therapeutics Ltd","started":"2022-07-20","startedType":"actual","enrolled":82,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00003456","kind":"trial","name":"Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme","aka":[],"tldr":"A phase 2 trial of Antineoplastons in Glioma & glioblastoma, run by Burzynski Research Institute, completed.","summary":"Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme is a phase 2 interventional study registered as NCT00003456 by Burzynski Research Institute, with 40 participants recorded, started 1995-03-14 and reaching its primary completion in 2004-12-07. Interventions recorded: Antineoplaston therapy (Atengenal + Astugenal). Conditions recorded: Glioblastoma Multiforme of Brain.\n\nLinked to the technology Antineoplastons because the registry's title names it (\"antineoplastons\") and Glioma & glioblastoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00003456","url":"https://clinicaltrials.gov/study/NCT00003456"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["antineoplastons"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003456","phase":"2","setting":"Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Glioblastoma Multiforme","sponsor":"Burzynski Research Institute","started":"1995-03-14","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00003475","kind":"trial","name":"Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors","aka":[],"tldr":"A phase 2 trial of Antineoplastons in Brain and spinal cord tumours, run by Burzynski Research Institute, completed.","summary":"Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors is a phase 2 interventional study registered as NCT00003475 by Burzynski Research Institute, with 40 participants recorded, started 1996-02 and reaching its primary completion in 2011-05. Interventions recorded: Antineoplaston therapy (Atengenal + Astugenal). Conditions recorded: Malignant Brain Tumors.\n\nLinked to the technology Antineoplastons because the registry's title names it (\"antineoplastons\") and Brain and spinal cord tumours among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00003475","url":"https://clinicaltrials.gov/study/NCT00003475"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["brain-tumours"],"sections":[],"technologies":["antineoplastons"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003475","phase":"2","setting":"Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Primary Malignant Brain Tumors","sponsor":"Burzynski Research Institute","started":"1996-02","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"apact","kind":"trial","name":"APACT","aka":["ABI-007-PANC-003"],"tldr":"APACT tested whether adding nab-paclitaxel to gemcitabine after pancreatic surgery delays relapse; by the independent radiologists' reading it did not (19.4 against 18.8 months), although patients on the combination lived about four months longer at five years, so the regimen is not a formal adjuvant standard.","summary":"APACT randomised 866 treatment-naive patients with resected pancreatic ductal adenocarcinoma to nab-paclitaxel 125 mg/m2 with gemcitabine 1,000 mg/m2 or gemcitabine alone on days 1, 8 and 15 of six 28-day cycles; 287 of 432 and 310 of 434 completed treatment. At the primary cut-off (December 2018, median follow-up 38.5 months) independently assessed disease-free survival was 19.4 against 18.8 months (hazard ratio 0.88, 95 percent confidence interval 0.729 to 1.063; p 0.18), so the trial missed its primary endpoint; investigator-assessed disease-free survival was 16.6 against 13.7 months (hazard ratio 0.82; p 0.02). Overall survival favoured the combination at every cut: 40.5 against 36.2 months (hazard ratio 0.82; p 0.045) at the primary analysis and 41.8 against 37.7 months (hazard ratio 0.80; p 0.0091) at five years with 88 percent of events. Grade 3 or worse treatment-emergent adverse events occurred in 86 against 68 percent, with two treatment-related deaths per arm. The trial recruited at six UK sites (Addenbrooke's Cambridge, Glasgow Royal Infirmary and Weston Park Sheffield among them). Because the primary endpoint was missed the regimen sits below modified FOLFIRINOX and gemcitabine plus capecitabine in guidelines, and the discordance between central and local reading of relapse became a design lesson for later adjuvant trials.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01964430","url":"https://clinicaltrials.gov/study/NCT01964430"},{"label":"Tempero et al., APACT (JCO 2023)","url":"https://doi.org/10.1200/JCO.22.01134"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel","nab-paclitaxel","gemcitabine"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["pancreatic-failed-programmes"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 6): Addenbrooke's Hospital Cambridge, Glasgow Royal Infirmary, Weston Park Hospital Sheffield and their local institution entries."],"nct":"NCT01964430","phase":"3","setting":"Resected pancreatic ductal adenocarcinoma at 179 sites in 21 countries: six cycles of adjuvant nab-paclitaxel plus gemcitabine against gemcitabine alone, with independently assessed disease-free survival as the primary endpoint","sponsor":"Celgene (Bristol Myers Squibb)","result":"Independently assessed disease-free survival 19.4 against 18.8 months (hazard ratio 0.88; p 0.18), primary endpoint not met; overall survival 41.8 against 37.7 months at five years (hazard ratio 0.80; p 0.0091).","started":"2014-03-28","startedType":"actual","yearReported":2023,"enrolled":866,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival (independent review)","primary":true,"unit":"months","arms":[{"name":"Adjuvant nab-paclitaxel + gemcitabine","n":432,"value":19.4},{"name":"Adjuvant gemcitabine","n":434,"value":18.8}],"hr":0.88,"ci":[0.729,1.063],"p":"0.18","source":"https://doi.org/10.1200/JCO.22.01134"},{"endpoint":"Overall survival (5-year follow-up, 88% mature)","unit":"months","arms":[{"name":"Adjuvant nab-paclitaxel + gemcitabine","n":432,"value":41.8},{"name":"Adjuvant gemcitabine","n":434,"value":37.7}],"hr":0.8,"ci":[0.678,0.947],"p":"0.0091","source":"https://doi.org/10.1200/JCO.22.01134"}]},{"id":"nct05019690","kind":"trial","name":"Apatinib Combined with Albumin-Bound Paclitaxel for Treatment of Advanced Triple Negative Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of rivoceranib (apatinib) and nab-paclitaxel in triple-negative breast cancer, run by Fujian Cancer Hospital, now recruiting.","summary":"Apatinib Combined with Albumin-Bound Paclitaxel for Treatment of Advanced Triple Negative Breast Cancer is a phase 1/2, interventional study registered as NCT05019690 by Fujian Cancer Hospital, with a registry enrolment figure of 29 participants, started 2021-10-01 and due to reach its primary completion in 2024-12-01. Interventions recorded: Apatinib Mesylate; Albumin-Bound Paclitaxel. Conditions listed: Advanced Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Histologically or pathologically confirmed advanced triple-negative breast cancer that meets the following criteria:\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05019690","url":"https://clinicaltrials.gov/study/NCT05019690"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["rivoceranib","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05019690","phase":"1/2","setting":"Apatinib Mesylate Combined with Albumin-bound Paclitaxel for Second-line Treatment of Advanced Triple Negative Breast Cancer:a Single-arm,exploratory Clinical Study","sponsor":"Fujian Cancer Hospital","started":"2021-10-01","startedType":"actual","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05701306","kind":"trial","name":"APG-115 Alone or in Combination With APG-2575 in Recurrent or Refractory Neuroblastoma or Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of APG-115 in neuroblastoma, run by Ascentage Pharma Group Inc., now recruiting.","summary":"APG-115 Alone or in Combination With APG-2575 in Recurrent or Refractory Neuroblastoma or Solid Tumors is a phase 1/2 interventional study registered as NCT05701306 by Ascentage Pharma Group Inc., with 100 participants planned, started 2023-02-28 and due to reach its primary completion in 2027-06-01. Interventions recorded: APG-115 and APG-2575.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05701306","url":"https://clinicaltrials.gov/study/NCT05701306"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ascentage-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05701306","phase":"1/2","setting":"A Phase Ib-ⅡClinical Study of APG-115 Alone or in Combination With APG-2575 in Recurrent or Refractory Neuroblastoma or Solid Tumors","sponsor":"Ascentage Pharma Group Inc.","started":"2023-02-28","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04785196","kind":"trial","name":"APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Toripalimab in sarcomas, run by Ascentage Pharma Group Inc., now recruiting.","summary":"APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT04785196 by Ascentage Pharma Group Inc., with 95 participants planned, started 2021-05-26 and due to reach its primary completion in 2026-04. Interventions recorded: APG-115 and Toripalimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04785196","url":"https://clinicaltrials.gov/study/NCT04785196"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma","liposarcoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":["ascentage-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04785196","phase":"1/2","setting":"A Phase Ib/II Study of APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Other Advanced Solid Tumors","sponsor":"Ascentage Pharma Group Inc.","started":"2021-05-26","startedType":"actual","enrolled":95,"enrolledBasis":"registry","outcomes":[]},{"id":"aphinity","kind":"trial","name":"APHINITY","aka":[],"tldr":"Adding pertuzumab after surgery helps women whose cancer had reached the lymph nodes, by a few percentage points, and does not help those with node-negative disease.","summary":"APHINITY, trial NCT01358877 sponsored by Roche and the Breast International Group and reported in 2017, showed that adding pertuzumab to trastuzumab and chemotherapy after surgery helps women whose HER2-positive breast cancer had reached the lymph nodes, by a few percentage points, and does not help those with node-negative disease. It randomised 4,805 women and met its primary invasive disease-free survival endpoint at eight years with a modest overall effect, an absolute gain of about five points in node-positive disease and none in node-negative disease, while overall survival was not significantly different, leading to pertuzumab's restriction to higher-risk disease. Whether a few points of disease-free survival justify a year of an expensive antibody is the question it left.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01358877","url":"https://clinicaltrials.gov/study/NCT01358877"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["pertuzumab","trastuzumab"],"companies":["breast-cancer-trials"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["david-cameron"],"bottlenecks":[],"keyPapers":["paper-aphinity-nejm-2017","paper-aphinity-j-clin-oncol-2024-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01358877","phase":"3","setting":"Adjuvant HER2+ early breast cancer: pertuzumab + trastuzumab + chemotherapy vs placebo + trastuzumab + chemotherapy","sponsor":"Roche / BIG","result":"8-year iDFS HR 0.78; node-positive absolute +4.9%.","started":"2011-11-08","startedType":"actual","yearReported":2017,"enrolled":4805,"enrolledBasis":"registry","outcomes":[{"endpoint":"8-year invasive disease-free survival","primary":true,"unit":"%","arms":[{"name":"Pertuzumab arm","n":2400,"value":88.4},{"name":"Placebo arm","n":2405,"value":85.8}],"hr":0.78,"ci":[0.66,0.92],"source":"https://ascopubs.org/doi/10.1200/JCO.23.02231"}],"replication":"Consistent with neoadjuvant pCR data (NeoSphere, TRYPHAENA); OS benefit not shown."},{"id":"nct07160686","kind":"trial","name":"Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment","aka":["THROMBO-STOP"],"tldr":"A phase 3 trial in lung cancer, run by University of Birmingham, not yet recruiting.","summary":"Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment is a phase 3, randomised interventional study registered as NCT07160686 by University of Birmingham, with a registry enrolment figure of 1456 participants, started 2026-03-02 and due to reach its primary completion in 2029-09-30. Interventions recorded: Apixaban; Placebo. Conditions listed: Thromboprophylaxis. Primary outcome: 18.3.1.1 Objectively confirmed VTE. Lung eligibility wording from the registry: \"* Newly diagnosed locally advanced or metastatic primary lung cancer (histologically/ cytologically confirmed) or disease progression after complete or partial remission commencing a new course of SACT alone or as CRT\". Sites: United Kingdom. United Kingdom sites listed: 1. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07160686","url":"https://clinicaltrials.gov/study/NCT07160686"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): University of Birmingham (Birmingham)."],"nct":"NCT07160686","phase":"3","setting":"A Phase III, Multicentre, Double Blind, Placebo-Controlled, Randomised Clinical Trial of Apixaban THROMBOprophylaxiS TO Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment","sponsor":"University of Birmingham","started":"2026-03-02","startedType":"estimated","enrolled":1456,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03175224","kind":"trial","name":"APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors","aka":["SPARTA"],"tldr":"A phase 2 trial of Vebreltinib in metastatic cancer and thyroid cancer, run by Apollomics Inc., now recruiting.","summary":"APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors is a phase 2 interventional study registered as NCT03175224 by Apollomics Inc., with 497 participants planned, started 2017-09-27 and due to reach its primary completion in 2026-03-30. Interventions recorded: APL-101 Oral Capsules. Conditions listed: Solid Tumors, Advanced Cancer, Renal Cancer, Gastric Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03175224","url":"https://clinicaltrials.gov/study/NCT03175224"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","thyroid"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["vebreltinib"],"companies":["apollomics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03175224","phase":"2","setting":"Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors","sponsor":"Apollomics Inc.","started":"2017-09-27","startedType":"actual","enrolled":497,"enrolledBasis":"registry","outcomes":[]},{"id":"apl0406","kind":"trial","name":"APL0406","aka":["GIMEMA-AMLSG-SAL APL0406"],"tldr":"APL0406 showed that acute promyelocytic leukaemia can be cured without conventional chemotherapy: retinoic acid plus arsenic trioxide did at least as well as, and in fact better than, the standard chemotherapy-based treatment.","summary":"The Italian-German APL0406 trial randomised adults with newly diagnosed acute promyelocytic leukaemia and a white cell count of 10 x 10^9/L or less to all-trans retinoic acid plus arsenic trioxide for induction and consolidation, or to all-trans retinoic acid plus idarubicin induction followed by anthracycline-based consolidation and maintenance. The primary endpoint was event-free survival at two years, tested for non-inferiority.\n\nThe chemotherapy-free arm was not only non-inferior but superior for event-free and overall survival, with fewer infections and deaths in remission, and the advantage held in the extended analysis with more patients. Retinoic acid plus arsenic became the worldwide standard for non-high-risk disease, the first cure of a leukaemia without cytotoxic chemotherapy.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00482833","url":"https://clinicaltrials.gov/study/NCT00482833"}],"tags":["subtype-trials"],"related":[],"cancers":["apl","aml"],"sections":[],"technologies":["epigenetic-drugs"],"targets":[],"drugs":["tretinoin-atra","arsenic-trioxide"],"companies":["gimema"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["francesco-lo-coco"],"bottlenecks":[],"keyPapers":["paper-apl0406-lo-coco-nejm-2013"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00482833","phase":"3","setting":"Newly diagnosed low- or intermediate-risk acute promyelocytic leukaemia: all-trans retinoic acid plus arsenic trioxide against all-trans retinoic acid plus idarubicin chemotherapy","sponsor":"GIMEMA (with AMLSG and SAL)","result":"All-trans retinoic acid plus arsenic trioxide was superior to retinoic acid plus chemotherapy for event-free and overall survival in non-high-risk APL.","started":"2007-08","yearReported":2013,"enrolled":276,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 2 years","primary":true,"unit":"%","arms":[{"name":"ATRA + arsenic trioxide","value":97,"note":"Median follow-up 34.4 months"},{"name":"ATRA + chemotherapy","value":86}],"p":"<0.001 for non-inferiority; 0.02 for superiority","source":"https://doi.org/10.1056/NEJMoa1300874"},{"endpoint":"Complete remission","unit":"%","arms":[{"name":"ATRA + arsenic trioxide","n":77,"value":100},{"name":"ATRA + chemotherapy","n":79,"value":95}],"p":"0.12","source":"https://doi.org/10.1056/NEJMoa1300874"}]},{"id":"nct01102426","kind":"trial","name":"Aplidin - Dexamethasone in Relapsed/Refractory Myeloma","aka":["ADMYRE"],"tldr":"A phase 3 trial of Plitidepsin and Dexamethasone in Multiple myeloma, run by PharmaMar, completed.","summary":"Aplidin - Dexamethasone in Relapsed/Refractory Myeloma is a phase 3 interventional study registered as NCT01102426 by PharmaMar, with 255 participants recorded, started 2010-06 and reaching its primary completion in 2017-11. Interventions recorded: Plitidepsin, Dexamethasone. Conditions recorded: Relapsed/Refractory Multiple Myeloma.\n\nLinked to the drug Plitidepsin because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01102426","url":"https://clinicaltrials.gov/study/NCT01102426"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["plitidepsin","dexamethasone"],"companies":["pharmamar"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01102426","phase":"3","setting":"Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma","sponsor":"PharmaMar","started":"2010-06","yearReported":2020,"enrolled":255,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) as Per Intention-to-treat (ITT)","primary":true,"unit":"months","arms":[{"name":"Plitidepsin+Dexamethasone","n":171,"value":2.6,"note":"95% CI 1.9 to 3.0; Figures from the ClinicalTrials.gov results section (first posted 2020-10-22), not from a publication"},{"name":"Dexamethasone","n":84,"value":1.7,"note":"95% CI 1.1 to 2.0"}],"hr":0.65,"ci":[0.447,0.885],"p":"0.0054","source":"https://clinicaltrials.gov/study/NCT01102426?tab=results"},{"endpoint":"Percentage of Participants With Progression Free Survival (PFS) as Per Intention-to-treat (ITT) at 6 Months","primary":true,"unit":"%","arms":[{"name":"Plitidepsin+Dexamethasone","n":171,"value":20,"note":"95% CI 13.1 to 26.9; Figures from the ClinicalTrials.gov results section (first posted 2020-10-22), not from a publication"},{"name":"Dexamethasone","n":84,"value":10,"note":"95% CI 2.0 to 18.0"}],"p":"0.0618","source":"https://clinicaltrials.gov/study/NCT01102426?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"Plitidepsin+Dexamethasone","n":171,"value":11.6,"note":"95% CI 9.2 to 16.1; Figures from the ClinicalTrials.gov results section (first posted 2020-10-22), not from a publication"},{"name":"Dexamethasone","n":84,"value":8.9,"note":"95% CI 6.0 to 15.4"}],"hr":0.797,"ci":[0.596,1.067],"p":"0.1261","source":"https://clinicaltrials.gov/study/NCT01102426?tab=results"},{"endpoint":"Overall Response Rate (Independent Review Committee)","unit":"%","arms":[{"name":"Plitidepsin+Dexamethasone","n":171,"value":22.8,"note":"95% CI 16.8 to 29.8; Figures from the ClinicalTrials.gov results section (first posted 2020-10-22), not from a publication"},{"name":"Dexamethasone","n":84,"value":3.6,"note":"95% CI 0.7 to 10.1"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT01102426?tab=results"}]},{"id":"nct04858334","kind":"trial","name":"APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a","aka":[],"tldr":"A phase 2 trial of olaparib in pancreatic cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation is a phase 2, randomised interventional study registered as NCT04858334 by National Cancer Institute (NCI), with a registry enrolment figure of 152 participants, started 2021-06-22 and due to reach its primary completion in 2027-10-31. Interventions recorded: Biospecimen Collection; Computed Tomography; Magnetic Resonance Imaging; Olaparib; Placebo Administration. Conditions listed: Pancreatic Acinar Cell Carcinoma; Pancreatic Adenosquamous Carcinoma; Pancreatic Squamous Cell Carcinoma; Resectable Pancreatic Acinar Cell Carcinoma; Resectable Pancreatic Adenocarcinoma; Resectable Pancreatic Adenosquamous Carcinoma; Resectable Pancreatic Carcinoma. Primary outcome: Improvement in relapse-free survival (RFS). Pancreatic eligibility wording from the registry: \"* Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator\". Sites: Israel, Puerto Rico, United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04858334","url":"https://clinicaltrials.gov/study/NCT04858334"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac","brca-palb2-pdac"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["olaparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04858334","phase":"2","setting":"APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation","sponsor":"National Cancer Institute (NCI)","started":"2021-06-22","startedType":"actual","enrolled":152,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05701436","kind":"trial","name":"Applicability of 3D-HDRA in Patients With Primary Liver Cancer: A Randomized Controlled Trial","aka":[],"tldr":"A phase 3 trial of Oxaliplatin, Doxorubicin, Cisplatin and Raltitrexed in Hepatocellular carcinoma, run by Zhujiang Hospital, with a status the registry has not verified recently.","summary":"Applicability of 3D-HDRA in Patients With Primary Liver Cancer: A Randomized Controlled Trial is a phase 3 interventional study registered as NCT05701436 by Zhujiang Hospital, with 144 participants planned, started 2022-09-01 and due to reach its primary completion in 2026-01-01. Interventions recorded: Oxaliplatin, Doxorubicin, Lobaplatin, Cisplatin, Oxaliplatin, Leucovorin, fluorouracil, Lobaplatin, Raltitrexed. Conditions recorded: Liver, Cancer of, Primary Resectable.\n\nLinked to the drug Raltitrexed because the registry names it among its interventions and Hepatocellular carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05701436","url":"https://clinicaltrials.gov/study/NCT05701436"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":[],"targets":[],"drugs":["oxaliplatin","doxorubicin","cisplatin","raltitrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05701436","phase":"3","setting":"Applicability of 3D Histoculture Drug Response Assay(3D-HDRA) in Patients With Primary Liver Cancer: A Randomized Controlled Trial","sponsor":"Zhujiang Hospital","started":"2022-09-01","startedType":"actual","enrolled":144,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05766605","kind":"trial","name":"Applicability of PDOX in Patients With Primary Liver Cancer: A Randomized Controlled Trial","aka":[],"tldr":"A phase 3 trial of Oxaliplatin, Doxorubicin, Cisplatin and Raltitrexed in Hepatocellular carcinoma, run by Zhujiang Hospital, with a status the registry has not verified recently.","summary":"Applicability of PDOX in Patients With Primary Liver Cancer: A Randomized Controlled Trial is a phase 3 interventional study registered as NCT05766605 by Zhujiang Hospital, with 90 participants planned, started 2023-01-01 and due to reach its primary completion in 2026-01-01. Interventions recorded: Oxaliplatin, Doxorubicin, Lobaplatin, Cisplatin, Oxaliplatin, Leucovorin, fluorouracil, Lobaplatin, Raltitrexed. Conditions recorded: Hepatocellular Carcinoma Resectable.\n\nLinked to the drug Raltitrexed because the registry names it among its interventions and Hepatocellular carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05766605","url":"https://clinicaltrials.gov/study/NCT05766605"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":[],"targets":[],"drugs":["oxaliplatin","doxorubicin","cisplatin","raltitrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05766605","phase":"3","setting":"Applicability of Patient Derived Orthotopic Xenograft (PDOX) in Patients With Primary Liver Cancer: A Randomized Controlled Trial","sponsor":"Zhujiang Hospital","started":"2023-01-01","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"apt-trial","kind":"trial","name":"APT (adjuvant paclitaxel-trastuzumab)","aka":[],"tldr":"For small HER2-positive tumours, a gentle regimen of weekly paclitaxel plus trastuzumab gives excellent cure rates, avoiding harsher chemotherapy.","summary":"APT, trial NCT00542451 sponsored by Dana-Farber and reported in 2015, showed that for small, node-negative HER2-positive breast tumours of three centimetres or less, a gentle regimen of twelve weeks of weekly paclitaxel plus a year of trastuzumab gives excellent cure rates, avoiding harsher chemotherapy. It was a single-arm study of 410 women in which almost all remained free of disease at seven years and free of recurrence at ten, and it became the standard for stage I disease without a randomised trial. OnCo links it to paclitaxel, trastuzumab, Sara M. Tolaney and the bottleneck of wrong doses, and the ATEMPT trial of trastuzumab emtansine alone showed comparable outcomes without a toxicity advantage. Whether even less treatment, such as trastuzumab without chemotherapy, would suffice for the smallest tumours is the open question. Trastuzumab has its own page.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00542451","url":"https://clinicaltrials.gov/study/NCT00542451"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["paclitaxel","trastuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sara-tolaney"],"bottlenecks":[],"keyPapers":["paper-apt-tolaney-nejm-2015","paper-apt-trial-lancet-oncol-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00542451","phase":"2","setting":"Small (≤3 cm), node-negative HER2+ breast cancer: 12 weeks paclitaxel + 1 year trastuzumab","sponsor":"Dana-Farber","result":"7-year DFS 93%; 10-year RFI 96.3%.","started":"2007-10","yearReported":2015,"enrolled":406,"enrolledBasis":"registry","outcomes":[{"endpoint":"7-year disease-free survival","primary":true,"unit":"%","arms":[{"name":"Paclitaxel + trastuzumab","n":406,"value":93}],"source":"https://ascopubs.org/doi/10.1200/JCO.19.00066"}],"replication":"ATEMPT (T-DM1) as an alternative de-escalated regimen showed comparable outcomes."},{"id":"aquila","kind":"trial","name":"AQUILA","aka":[],"tldr":"AQUILA showed that treating high-risk smouldering myeloma with the antibody daratumumab, rather than waiting for it to turn into active disease, delayed that progression, making it the first drug shown in a randomised trial to hold back myeloma before it causes symptoms.","summary":"AQUILA was an open-label phase 3 trial in patients with smouldering multiple myeloma judged high risk by disease burden and biomarkers. Patients were randomised to subcutaneous daratumumab monotherapy for up to 39 cycles or three years, or to active monitoring, the standard of care.\n\nDaratumumab significantly prolonged progression-free survival, defined as progression to active myeloma by SLiM-CRAB criteria or death, the primary endpoint. It was the first phase 3 trial of a monoclonal antibody in this precursor state and led to approval of daratumumab for high-risk smouldering myeloma in the United States in 2025. The earlier E3A06 trial had shown a similar effect with lenalidomide but without a survival benefit; how to define high risk well enough to justify treatment remains the live question.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03301220","url":"https://clinicaltrials.gov/study/NCT03301220"}],"tags":["subtype-trials"],"related":[],"cancers":["smouldering-myeloma","multiple-myeloma"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["daratumumab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["meletios-dimopoulos"],"bottlenecks":[],"keyPapers":["paper-aquila-daratumumab-smouldering-nejm-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03301220","phase":"3","setting":"High-risk smouldering multiple myeloma: subcutaneous daratumumab alone for up to three years against active monitoring","sponsor":"Janssen","result":"Subcutaneous daratumumab delayed progression to active myeloma or death compared with active monitoring in high-risk smouldering myeloma; approved in the United States in 2025.","started":"2017-11-07","startedType":"actual","yearReported":2024,"enrolled":390,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 5 years (progression to active myeloma or death)","primary":true,"unit":"%","arms":[{"name":"Subcutaneous daratumumab","n":194,"value":63.1,"note":"Median follow-up 65.2 months"},{"name":"Active monitoring","n":196,"value":40.8}],"hr":0.49,"ci":[0.36,0.67],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa2409029"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Subcutaneous daratumumab","n":194,"value":93},{"name":"Active monitoring","n":196,"value":86.9}],"hr":0.52,"ci":[0.27,0.98],"source":"https://doi.org/10.1056/NEJMoa2409029"}]},{"id":"aramis","kind":"trial","name":"ARAMIS","aka":[],"tldr":"ARAMIS showed that darolutamide, an androgen receptor blocker that barely enters the brain, delayed metastases and lengthened life in men whose prostate cancer was rising on hormone therapy but not yet visible on scans, with side effects close to placebo.","summary":"ARAMIS randomised 1509 men with non-metastatic castration-resistant prostate cancer and a PSA doubling time of ten months or less two to one to darolutamide or placebo alongside androgen deprivation. The primary endpoint was metastasis-free survival.\n\nDarolutamide lengthened metastasis-free survival substantially and improved overall survival in the final analysis, with rates of fatigue, falls, fractures, seizures and cognitive effects that were close to placebo, a tolerability profile attributed to its low penetration of the blood-brain barrier. It was approved in the United States in July 2019 and is often preferred among the three androgen receptor inhibitors for this setting in older men.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02200614","url":"https://clinicaltrials.gov/study/NCT02200614"},{"label":"NICE TA660: darolutamide with androgen deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta660"}],"tags":["subtype-trials"],"related":[],"cancers":["prostate-nmcrpc","prostate"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["darolutamide"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":["prostate-uk-drug-approvals","metastasis-free-survival"],"trials":["nct01946204","prosper"],"people":["karim-fizazi"],"bottlenecks":[],"keyPapers":["paper-aramis-nejm-2019"],"journals":[],"dependsOn":[],"notes":["In England NICE TA660 recommends darolutamide with androgen deprivation within its marketing authorisation for hormone-relapsed prostate cancer in adults at high risk of developing metastatic disease, subject to the commercial arrangement. The committee noted that the only current option at this stage is to continue androgen deprivation alone, accepted that darolutamide delays spread, and said that although the trial suggests it lengthens life it is unclear by how much in the long term."],"nct":"NCT02200614","phase":"3","setting":"High-risk non-metastatic castration-resistant prostate cancer: darolutamide against placebo, both with continued androgen deprivation","sponsor":"Bayer","result":"Darolutamide lengthened metastasis-free and overall survival compared with placebo with a near-placebo side-effect profile; approved in July 2019.","started":"2014-09-12","startedType":"actual","yearReported":2019,"enrolled":1509,"enrolledBasis":"registry","outcomes":[{"endpoint":"Metastasis-free survival (planned primary analysis)","primary":true,"unit":"months","arms":[{"name":"Darolutamide","n":955,"value":40.4},{"name":"Placebo","n":554,"value":18.4}],"hr":0.41,"ci":[0.34,0.5],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1815671"},{"endpoint":"Discontinuation for adverse events","unit":"%","arms":[{"name":"Darolutamide","value":8.9},{"name":"Placebo","value":8.7}],"source":"https://doi.org/10.1056/NEJMoa1815671"}]},{"id":"aranote","kind":"trial","name":"ARANOTE","aka":[],"tldr":"ARANOTE showed that darolutamide added to hormone therapy alone, without chemotherapy, delayed the progression of newly metastatic prostate cancer on scans, extending the drug's use to men who cannot or do not want to have docetaxel.","summary":"ARASENS had established darolutamide with docetaxel and androgen deprivation for metastatic hormone-sensitive prostate cancer. ARANOTE randomised 669 men with metastatic hormone-sensitive disease two to one to androgen deprivation therapy with darolutamide or with placebo, without docetaxel. The primary endpoint was radiographic progression-free survival.\n\nDarolutamide lengthened radiographic progression-free survival with a tolerability profile again close to placebo, and the result led to approval of darolutamide with androgen deprivation alone for metastatic hormone-sensitive disease in 2025. It gave darolutamide the same two-drug indication that apalutamide (TITAN) and enzalutamide (ARCHES, ENZAMET) already held.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04736199","url":"https://clinicaltrials.gov/study/NCT04736199"},{"label":"NICE TA1109: darolutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta1109"}],"tags":["subtype-trials"],"related":[],"cancers":["prostate-mhspc","prostate"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["darolutamide"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":["prostate-uk-drug-approvals"],"trials":["arasens","nct02489318"],"people":["fred-saad"],"bottlenecks":[],"keyPapers":["paper-aranote-eur-urol-2026"],"journals":[],"dependsOn":[],"notes":["In England NICE TA1109 recommends darolutamide with androgen deprivation for hormone-sensitive metastatic prostate cancer only if docetaxel is not suitable, and instructs prescribers to use the least expensive of the suitable treatments, which includes apalutamide with androgen deprivation, taking account of administration costs, dosages, price per dose and commercial arrangements. Darolutamide with androgen deprivation and docetaxel is covered separately by TA903."],"nct":"NCT04736199","phase":"3","setting":"Metastatic hormone-sensitive prostate cancer: androgen deprivation with darolutamide or placebo, without docetaxel","sponsor":"Bayer","result":"Darolutamide plus androgen deprivation lengthened radiographic progression-free survival compared with androgen deprivation alone; approved for this use in 2025.","started":"2021-02-23","startedType":"actual","yearReported":2024,"enrolled":669,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiological progression-free survival by central review (registry results)","primary":true,"unit":"months","arms":[{"name":"Darolutamide + androgen deprivation therapy","note":"Median not reached"},{"name":"Placebo + androgen deprivation therapy","value":25,"note":"95% CI 19.0 to not reached"}],"hr":0.541,"ci":[0.413,0.707],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT04736199?tab=results"}]},{"id":"arasens","kind":"trial","name":"ARASENS","aka":[],"tldr":"Proved 'triplet therapy': adding darolutamide to hormone therapy plus chemotherapy reduces death by a third.","summary":"ARASENS, trial NCT02799602 sponsored by Bayer and Orion and reported in 2022, proved triplet therapy in metastatic hormone-sensitive prostate cancer: adding darolutamide to androgen deprivation plus docetaxel reduces the risk of death by about a third compared with hormone therapy and docetaxel alone. It randomised 1,306 men and met its primary overall survival endpoint, with benefit in both high-volume and low-volume subgroups. OnCo links it to prostate cancer, darolutamide, docetaxel and Matthew R. Smith, and its result is consistent with PEACE-1, which tested an abiraterone triplet in de novo metastatic disease. Because every patient received docetaxel, the trial cannot say whether the chemotherapy was needed on top of darolutamide, which is the main open question. Darolutamide has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT02799602","url":"https://clinicaltrials.gov/study/NCT02799602"},{"label":"NICE TA903: darolutamide with androgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta903"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["darolutamide","docetaxel"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":["prostate-uk-drug-approvals"],"trials":["peace-1","chaarted"],"people":["matthew-smith"],"bottlenecks":[],"keyPapers":["paper-arasens-nejm-2022"],"journals":[],"dependsOn":[],"notes":["In England NICE TA903 recommends darolutamide with docetaxel within its marketing authorisation for hormone-sensitive metastatic prostate cancer, subject to the commercial arrangement. The committee noted that usual treatment always includes androgen deprivation, given alone or with docetaxel or enzalutamide, and accepted both the direct trial evidence and an indirect comparison against usual treatment."],"nct":"NCT02799602","phase":"3","setting":"Metastatic hormone-sensitive prostate cancer: ADT + docetaxel + darolutamide vs ADT + docetaxel","sponsor":"Bayer / Orion","result":"OS HR 0.68.","started":"2016-11-30","startedType":"actual","yearReported":2022,"enrolled":1306,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Darolutamide + ADT + docetaxel","n":651,"note":"Median not reached"},{"name":"Placebo + ADT + docetaxel","n":655,"value":48.9}],"hr":0.68,"ci":[0.57,0.8],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2119115"}],"replication":"Consistent with PEACE-1 (abiraterone triplet) in de novo metastatic disease."},{"id":"arched","kind":"trial","name":"ARCHED","aka":["ARCHED trial","Acalabrutinib with R-miniCHOP"],"tldr":"A German trial adding a targeted tablet to the reduced-dose chemotherapy used for older people with aggressive lymphoma, to see whether it delays relapse.","summary":"Bruton tyrosine kinase inhibitors have a clear rationale in the activated B-cell genetic subtypes of diffuse large B-cell lymphoma, which depend on chronic active B-cell receptor signalling, and a mixed record in practice: the PHOENIX trial of ibrutinib with R-CHOP improved outcomes in patients under 60 and harmed those over 60, because of toxicity rather than biology. Acalabrutinib is more selective and better tolerated.\n\nARCHED randomises older adults with untreated diffuse large B-cell lymphoma between R-miniCHOP alone and R-miniCHOP with acalabrutinib. The primary endpoint is investigator-assessed progression-free survival, with primary completion estimated for February 2029, and the trial is running at German sites.\n\nIt is the direct test of whether the age signal in PHOENIX was a property of ibrutinib or of the class, in the population where the answer matters most.","status":"active","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT05820841","url":"https://clinicaltrials.gov/study/NCT05820841"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["dlbcl","non-hodgkin-lymphoma"],"sections":["targeted-therapy","chemotherapy"],"technologies":[],"targets":["btk","cd20"],"drugs":["acalabrutinib","rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":[],"institutions":[],"pathways":["bcr-signalling"],"terms":["r-chop","cell-of-origin"],"trials":["polar-bear"],"people":[],"bottlenecks":["b-aging-comorbidity","b-toxicity-qol"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05820841","phase":"3","setting":"Older adults with untreated diffuse large B-cell lymphoma: R-miniCHOP with or without acalabrutinib","sponsor":"Universität des Saarlandes","started":"2023-06-07","startedType":"actual","enrolled":330,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01360554","kind":"trial","name":"ARCHER 1009: A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of Dacomitinib and Erlotinib in Non-small-cell lung cancer, run by Pfizer, completed.","summary":"ARCHER 1009: A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT01360554 by Pfizer, with 878 participants recorded, started 2011-06-16 and reaching its primary completion in 2013-09-30. Interventions recorded: Dacomitinib (PF-00299804), Active Comparator (erlotinib), Placebo erlotinib, Placebo PF00299804. Conditions recorded: Non-Small Cell Lung Cancer.\n\nLinked to the drug Dacomitinib because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01360554","url":"https://clinicaltrials.gov/study/NCT01360554"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["dacomitinib","erlotinib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01360554","phase":"3","setting":"Archer 1009:a Randomized, Double Blind Phase 3 Efficacy And Safety Study Of Pf-00299804 (Dacomitinib) Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer Following Progression After, Or Intolerance To, At Least One Prior Chemotherapy","sponsor":"Pfizer","started":"2011-06-16","yearReported":2017,"enrolled":878,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Free Survival (PFS) Per Independent Radiologic Review.","primary":true,"unit":"months","arms":[{"name":"Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)","n":439,"value":2.6,"note":"95% CI 1.9 to 2.8; Figures from the ClinicalTrials.gov results section (first posted 2017-05-24), not from a publication"},{"name":"Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)","n":439,"value":2.5,"note":"95% CI 1.9 to 2.8"}],"hr":0.933,"ci":[0.797,1.093],"p":"0.195","source":"https://clinicaltrials.gov/study/NCT01360554?tab=results"},{"endpoint":"Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.","primary":true,"unit":"months","arms":[{"name":"Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)","n":256,"value":2.6,"note":"95% CI 1.9 to 2.9; Figures from the ClinicalTrials.gov results section (first posted 2017-05-24), not from a publication"},{"name":"Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)","n":263,"value":2.5,"note":"95% CI 1.9 to 3.0"}],"hr":1.037,"ci":[0.848,1.268],"p":"0.643","source":"https://clinicaltrials.gov/study/NCT01360554?tab=results"},{"endpoint":"Overall Survival (OS).","unit":"months","arms":[{"name":"Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)","n":439,"value":7.9,"note":"95% CI 6.8 to 9.0; Figures from the ClinicalTrials.gov results section (first posted 2017-05-24), not from a publication"},{"name":"Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)","n":439,"value":8.3,"note":"95% CI 7.4 to 9.7"}],"hr":1.026,"ci":[0.887,1.188],"p":"0.638","source":"https://clinicaltrials.gov/study/NCT01360554?tab=results"}]},{"id":"nct01774721","kind":"trial","name":"ARCHER 1050","aka":["A7471050","ARCHER1050","ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC","ARCHER 1050"],"tldr":"ARCHER 1050 showed that dacomitinib, a second-generation EGFR pill, kept untreated EGFR-mutant lung cancer under control longer than gefitinib, and a later analysis reported longer survival, though rash and diarrhoea were harsher and patients with brain metastases were excluded.","summary":"ARCHER 1050 was an open-label, randomised phase 3 trial at 71 centres in seven countries or regions that compared dacomitinib with gefitinib in 452 patients with newly diagnosed advanced non-small-cell lung cancer carrying an EGFR exon 19 deletion or L858R mutation. Patients received dacomitinib 45 mg once daily (227) or gefitinib 250 mg once daily (225). Randomisation was stratified by race and EGFR mutation type, patients with brain metastases were excluded, and the primary endpoint was progression-free survival by masked independent review.\n\nMedian progression-free survival was 14.7 months with dacomitinib against 9.2 months with gefitinib (hazard ratio 0.59, 95% CI 0.47 to 0.74; The Lancet Oncology 2017). By independent review 74.9 percent of patients responded on dacomitinib against 71.6 percent on gefitinib, a difference that was not statistically significant, and responses lasted a median of 14.8 against 8.3 months (registry results and US label). A separate mature analysis reported median overall survival of 34.1 months against 26.8 months (hazard ratio 0.76, 95% CI 0.58 to 0.99; Journal of Clinical Oncology 2018). The US label notes that overall survival was not formally tested, because the response rate comparison earlier in the prespecified testing order was not significant. Grade 3 or 4 dermatitis acneiform (14 percent) and diarrhoea (8 percent) were more common on dacomitinib.\n\nThe trial supported the 2018 US first-line approval of dacomitinib. Mok and colleagues described it as the first second-generation EGFR inhibitor to show an overall survival gain over a standard EGFR inhibitor in a phase 3 trial. FLAURA later made osimertinib the usual first-line EGFR inhibitor and displaced dacomitinib.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01774721","url":"https://clinicaltrials.gov/study/NCT01774721"},{"label":"The Lancet Oncology 2017","url":"https://doi.org/10.1016/S1470-2045(17)30608-3"},{"label":"Journal of Clinical Oncology 2018 (overall survival)","url":"https://doi.org/10.1200/JCO.2018.78.7994"},{"label":"Vizimpro label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4ab27d2f-e385-4e9c-b324-fa69c10b855a"},{"label":"ARCHER 1050 (Lancet Oncology 2017)","url":"https://doi.org/10.1016/S1470-2045(17)30608-3"},{"label":"NICE TA595: dacomitinib for untreated EGFR mutation-positive non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta595"}],"tags":[],"related":["flaura"],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["egfr"],"drugs":["dacomitinib","gefitinib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":["egfr-exon19-l858r","tki-term","brain-metastases"],"trials":["flaura","lux-lung-3"],"people":["wu-yi-long","tony-mok"],"bottlenecks":[],"keyPapers":["paper-archer-1050-lancet-oncol-2017","paper-archer-1050-os-jco-2018"],"journals":[],"dependsOn":[],"notes":["ARCHER 1050 enrolled 452 adults with newly diagnosed advanced non-small-cell lung cancer and a single EGFR mutation (exon 19 deletion or L858R) at 71 centres in seven countries or special administrative regions between May 2013 and March 2015, and randomised them 1:1 to dacomitinib 45 mg daily or gefitinib 250 mg daily in 28-day cycles until progression. Median progression-free survival by masked independent review was 14.7 months (95 percent confidence interval 11.1 to 16.6) against 9.2 months (9.1 to 11.0), hazard ratio 0.59 (0.47 to 0.74). The trial excluded patients with brain metastases, which is the main reason dacomitinib did not displace osimertinib (Lancet Oncology 2017). NICE TA595 (14 August 2019) recommends dacomitinib for untreated EGFR mutation-positive disease in England."],"nct":"NCT01774721","phase":"3","setting":"Untreated advanced non-small-cell lung cancer with an EGFR exon 19 deletion or L858R mutation: dacomitinib versus gefitinib","sponsor":"Pfizer","result":"Median progression-free survival 14.7 vs 9.2 months (hazard ratio 0.59, masked independent review); median overall survival 34.1 vs 26.8 months (hazard ratio 0.76) in a separate mature analysis.","started":"2013-05-09","startedType":"actual","yearReported":2017,"enrolled":452,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (masked independent review)","primary":true,"unit":"months","arms":[{"name":"Dacomitinib","n":227,"value":14.7},{"name":"Gefitinib","n":225,"value":9.2}],"hr":0.59,"ci":[0.47,0.74],"source":"https://doi.org/10.1016/S1470-2045(17)30608-3"},{"endpoint":"Overall survival (mature analysis)","unit":"months","arms":[{"name":"Dacomitinib","n":227,"value":34.1},{"name":"Gefitinib","n":225,"value":26.8}],"hr":0.76,"ci":[0.582,0.993],"p":"0.044","source":"https://doi.org/10.1200/JCO.2018.78.7994"},{"endpoint":"Objective response rate (independent radiologic review)","unit":"%","arms":[{"name":"Dacomitinib","n":227,"value":74.9},{"name":"Gefitinib","n":225,"value":71.6}],"source":"https://clinicaltrials.gov/study/NCT01774721?tab=results"},{"endpoint":"Duration of response (independent radiologic review)","unit":"months","arms":[{"name":"Dacomitinib","value":14.8,"note":"Responders only"},{"name":"Gefitinib","value":8.3,"note":"Responders only"}],"source":"https://clinicaltrials.gov/study/NCT01774721?tab=results"}],"replication":"No other trial compared dacomitinib with gefitinib first line; FLAURA compared osimertinib with gefitinib or erlotinib and became the usual first-line standard."},{"id":"arches","kind":"trial","name":"ARCHES","aka":[],"tldr":"Brought enzalutamide into first-line metastatic treatment, with an overall survival benefit confirmed in 2021.","summary":"ARCHES, trial NCT02677896 sponsored by Astellas and Pfizer and reported in 2019, brought enzalutamide into first-line treatment of metastatic hormone-sensitive prostate cancer, with an overall survival benefit confirmed in 2021. It randomised 1,150 men to androgen deprivation with enzalutamide or placebo, met its primary radiographic progression-free survival endpoint with a large effect, and later showed improved overall survival at the final analysis. OnCo links it to enzalutamide and to Andrew J. Armstrong, and the result was independently confirmed by ENZAMET and is consistent with TITAN for apalutamide, so the class effect is well replicated. Whether treatment intensity can be reduced in men who respond deeply is the open question the field has moved on to. Enzalutamide has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT02677896","url":"https://clinicaltrials.gov/study/NCT02677896"},{"label":"NICE TA712: enzalutamide for treating hormone-sensitive metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta712"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["enzalutamide"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":["prostate-uk-drug-approvals"],"trials":["enzamet"],"people":["andrew-armstrong"],"bottlenecks":[],"keyPapers":["paper-arches-j-clin-oncol-2019","paper-arches-eur-urol-2026-update"],"journals":[],"dependsOn":[],"notes":["ARCHES and ENZAMET together support the enzalutamide indication in hormone-sensitive metastatic disease that NICE TA712 recommends. TA712 places no restriction on prior docetaxel suitability, unlike TA741 for apalutamide and TA1109 for darolutamide, both of which apply only if docetaxel is not suitable."],"nct":"NCT02677896","phase":"3","setting":"Metastatic hormone-sensitive prostate cancer: ADT + enzalutamide vs ADT","sponsor":"Astellas / Pfizer","result":"rPFS HR 0.39; OS HR 0.66.","started":"2016-03-09","startedType":"actual","yearReported":2019,"enrolled":1150,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic progression-free survival","primary":true,"unit":"months","arms":[{"name":"ADT + enzalutamide","n":574,"note":"Median not reached"},{"name":"ADT + placebo","n":576,"value":19}],"hr":0.39,"ci":[0.3,0.5],"p":"<0.001","source":"https://ascopubs.org/doi/10.1200/JCO.19.00799"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"ADT + enzalutamide","note":"Medians not reached at the final analysis"},{"name":"ADT + placebo"}],"hr":0.66,"ci":[0.53,0.81],"source":"https://ascopubs.org/doi/10.1200/JCO.22.00193"}],"replication":"Replicated by ENZAMET (enzalutamide) and TITAN (apalutamide)."},{"id":"nct05800223","kind":"trial","name":"Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of aumolertinib in lung cancer, run by Shanghai Cancer Hospital, China, now recruiting.","summary":"Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT05800223 by Shanghai Cancer Hospital, China, with a registry enrolment figure of 300 participants, started 2023-01-01 and due to reach its primary completion in 2027-12. Interventions recorded: Almonertinib; SBRT. Conditions listed: Non-small Cell Lung Cancer Metastatic. Primary outcome: iPFS. Lung eligibility wording from the registry: \"histologically confirmed NSCLC (by AJCC 8th edition lung cancer staging criteria)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05800223","url":"https://clinicaltrials.gov/study/NCT05800223"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors","sbrt"],"targets":[],"drugs":["aumolertinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05800223","phase":"3","setting":"Prospective, Multicenter, Randomized Controlled, Phase III Clinical Study of Armatinib Alone or in Combination With Stereotactic Body Radiotherapy (SRT) for First-line Treatment of Brain Metastases From EGFR-mutated Non-small Cell Lung Cancer","sponsor":"Shanghai Cancer Hospital, China","started":"2023-01-01","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"armor3-sv","kind":"trial","name":"ARMOR3-SV","aka":["ARMOR3-SV","galeterone against enzalutamide in AR-V7 positive disease"],"tldr":"The only trial ever to pick men for prostate cancer treatment by a splice variant of the androgen receptor. It could not recruit, because the men who qualified were too ill to stay in it.","summary":"AR-V7 is a splice variant of the androgen receptor that lacks the ligand-binding domain and is constitutively active, so abiraterone and enzalutamide, which act on that domain or on the hormones feeding it, should not work against it. Galeterone degrades androgen receptor protein, including AR-V7, so it should. ARMOR3-SV was the trial designed to prove it.\n\nOf 953 men prescreened, 323 (34 percent) had detectable circulating tumour cells and 73 of the 953 had AR-V7 messenger RNA, a prevalence of 8 percent (95 percent confidence interval 6 to 10).\n\nAR-V7 positivity marked out advanced, aggressive disease: higher PSA (p<0.001), more bone metastases (p<0.001), more previous docetaxel for hormone-sensitive disease (p<0.001), more previous first-generation androgen deprivation (p<0.001) and a shorter time from diagnosis to enrolment (p<0.001).\n\nOf the 73 eligible men, 38 were randomised, 19 to galeterone and 19 to enzalutamide; 35 dropped out before randomisation. Because so many radiographic progression-free survival events were censored, the data monitoring committee recommended closure on interim evidence that the primary endpoint would not be met. PSA50 responses were 2 of 16 (13 percent) with galeterone and 8 of 19 (42 percent) with enzalutamide, difference -0.278 (95 percent confidence interval -0.490 to 0.097).\n\nDevelopment of galeterone stopped. The trial is a lesson about biomarker-selected trials in a disease that moves fast: if the biomarker marks men who are about to deteriorate, the trial will run out of patients before it runs out of endpoints.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02438007","url":"https://clinicaltrials.gov/study/NCT02438007"},{"label":"ARMOR3-SV (European Urology 2019)","url":"https://doi.org/10.1016/j.eururo.2019.08.034"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":["androgen-receptor","cyp17a1"],"drugs":["galeterone","enzalutamide"],"companies":[],"institutions":[],"pathways":[],"terms":["ar-v7","arpi","castration-resistance","psa50"],"trials":["affirm","prevail"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02438007","phase":"3","setting":"Metastatic castration-resistant prostate cancer with AR-V7 messenger RNA detectable in circulating tumour cells, in men naive to enzalutamide, abiraterone and chemotherapy: galeterone against enzalutamide, open-label, with radiographic progression-free survival as the primary endpoint","sponsor":"Tokai Pharmaceuticals","result":"Closed early after 38 of a planned 148 men were randomised; AR-V7 prevalence 8 percent (95 percent confidence interval 6 to 10) among 953 prescreened men. PSA50 response 13 percent with galeterone against 42 percent with enzalutamide. Galeterone development stopped.","started":"2015-06","yearReported":2019,"enrolled":38,"enrolledBasis":"randomised","enrolledNote":"953 men were prescreened for AR-V7 and 73 were eligible; only 38 were randomised before the data monitoring committee recommended early closure, against a planned sample size of 148.","outcomes":[{"endpoint":"AR-V7 prevalence in first-line metastatic castration-resistant prostate cancer","unit":"%","arms":[{"name":"Men prescreened","n":953,"value":8,"note":"95 percent confidence interval 6 to 10; detectable circulating tumour cells in 34 percent."}],"source":"https://doi.org/10.1016/j.eururo.2019.08.034"},{"endpoint":"PSA50 response","unit":"%","arms":[{"name":"Galeterone","n":16,"value":13},{"name":"Enzalutamide","n":19,"value":42}],"source":"https://doi.org/10.1016/j.eururo.2019.08.034"}]},{"id":"arrow-thyroid","kind":"trial","name":"ARROW (thyroid cohorts)","aka":[],"tldr":"ARROW is the single-arm study behind the second RET inhibitor's thyroid approvals.","summary":"ORR 71% in treatment-naive RET-mutant MTC and 60% after prior cabozantinib/vandetanib; 89% in RET-fusion thyroid cancer. Accelerated approval December 2020; the MTC indication was later withdrawn in the US (2023) when the confirmatory trial was not pursued, leaving selpercatinib as the RET-selective option for MTC.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03037385","url":"https://clinicaltrials.gov/study/NCT03037385"},{"label":"Lancet Diabetes & Endocrinology 2021","url":"https://www.thelancet.com/journals/landia/article/PIIS2213-8587(21)00120-0/fulltext"},{"label":"ARROW lung cohort (Lancet Oncology 2021)","url":"https://doi.org/10.1016/S1470-2045(21)00247-3"},{"label":"NICE TA812: pralsetinib for treating RET fusion-positive advanced non-small-cell lung cancer (not recommended)","url":"https://www.nice.org.uk/guidance/ta812"}],"tags":[],"related":[],"cancers":["thyroid","ret-fusion-nsclc","nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["ret"],"drugs":["pralsetinib"],"companies":["blueprint-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":["nct03157128","libretto-431"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["ARROW also enrolled a lung cohort. Of 233 patients with RET fusion-positive non-small-cell lung cancer enrolled between March 2017 and May 2020, 92 who had had platinum chemotherapy and 29 who were treatment-naive received pralsetinib 400 mg daily before the efficacy cutoff. Overall response was recorded in 53 of 87 previously treated patients with centrally adjudicated measurable disease (61 percent, 95 percent confidence interval 50 to 71), including five complete responses (Lancet Oncology 2021). NICE TA812 (3 August 2022) does not recommend pralsetinib for this indication in England."],"nct":"NCT03037385","phase":"1/2","setting":"RET-mutant medullary and RET-fusion thyroid cancer: pralsetinib","sponsor":"Blueprint Medicines","result":"ORR 71% (naive MTC), 89% (RET-fusion thyroid).","started":"2017-03-17","startedType":"actual","yearReported":2021,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate, treatment-naive RET-mutant MTC","unit":"%","arms":[{"name":"Pralsetinib","value":71}],"source":"https://www.thelancet.com/journals/landia/article/PIIS2213-8587(21)00120-0/fulltext"}],"replication":"LIBRETTO-001/531 with selpercatinib show the same RET-selective effect."},{"id":"nct06678048","kind":"trial","name":"Arsenous Acid for Refractory Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Sun Yat-sen University, now recruiting.","summary":"Arsenous Acid for Refractory Triple-Negative Breast Cancer is a phase 2, interventional study registered as NCT06678048 by Sun Yat-sen University, with a registry enrolment figure of 12 participants, started 2024-10-23 and due to reach its primary completion in 2026-04-22. Interventions recorded: Arsenous Acid plus Chemotherapy. Conditions listed: Breast Cancer. Triple-negative eligibility wording from the registry: \"For TNBC patients with a programmed death-ligand 1 (PD-L1/22C3) positive result (combined positive score, CPS ) ≥10, eligibility requires prior treatment with chemotherapy combined with PD-1\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06678048","url":"https://clinicaltrials.gov/study/NCT06678048"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06678048","phase":"2","setting":"A Single-Arm, Two Stage, Phase II Study of Arsenous Acid Combined With Palliative Chemotherapy for Refractory Triple-Negative Breast Cancer","sponsor":"Sun Yat-sen University","started":"2024-10-23","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05830123","kind":"trial","name":"ARTEMIS-002: HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas","aka":["ARTEMIS-002"],"tldr":"A phase 2 trial of HS-20093 in osteosarcoma, run by Hansoh BioMedical R&D Company, now recruiting.","summary":"ARTEMIS-002: HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas is a phase 2 interventional study registered as NCT05830123 by Hansoh BioMedical R&D Company, with 170 participants planned, started 2023-06-08 and due to reach its primary completion in 2025-12-31. Interventions recorded: HS-20093. Conditions listed: Osteosarcoma, Sarcoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05830123","url":"https://clinicaltrials.gov/study/NCT05830123"}],"tags":["ctgov-ingest"],"related":[],"cancers":["osteosarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["hs-20093"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05830123","phase":"2","setting":"ARTEMIS-002: A Phase 2, Multicenter, Open-label Study of Intravenous Administration of HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas","sponsor":"Hansoh BioMedical R&D Company","started":"2023-06-08","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06007729","kind":"trial","name":"ARTEMIS-006: HS-20093 in Patients With Head and Neck Squamous Cell Carcinoma and Other Solid Tumors","aka":["ARTEMIS-006"],"tldr":"A phase 2 trial of HS-20093 in head and neck squamous cell carcinoma, run by Hansoh BioMedical R&D Company, now recruiting.","summary":"ARTEMIS-006: HS-20093 in Patients With Head and Neck Squamous Cell Carcinoma and Other Solid Tumors is a phase 2 interventional study registered as NCT06007729 by Hansoh BioMedical R&D Company, with 170 participants planned, started 2023-12-18 and due to reach its primary completion in 2025-12-12. Interventions recorded: HS-20093. Conditions listed: Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06007729","url":"https://clinicaltrials.gov/study/NCT06007729"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":["hs-20093"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06007729","phase":"2","setting":"ARTEMIS-006: A Phase 2 Study to Evaluate Efficacy and Safety of Intravenous Administration of HS-20093 in Patients With Head and Neck Squamous Cell Carcinoma and Other Solid Tumors","sponsor":"Hansoh BioMedical R&D Company","started":"2023-12-18","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06498479","kind":"trial","name":"ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer","aka":["ARTEMIS-008"],"tldr":"A phase 3 trial testing HS-20093 in non-small-cell lung cancer, now recruiting.","summary":"ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06498479, led by Hansoh BioMedical R&D, and recruiting on the registry. Official title: ARTEMIS-008：A Multicenter, Randomised, Open-label, Phase 3 Study of HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy. Planned enrolment is 460 participants (estimated). The study started in 2024-07-04 and primary completion is expected in 2026-09-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06498479","url":"https://clinicaltrials.gov/study/NCT06498479"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["hs-20093"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06498479","phase":"3","setting":"ARTEMIS-008：A Multicenter, Randomized, Open-label, Phase 3 Study of HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy","sponsor":"Hansoh BioMedical R&D","started":"2024-07-04","startedType":"actual","enrolled":460,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04098744","kind":"trial","name":"Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)","aka":[],"tldr":"A phase 2 trial of Artesunate vaginal insert in vaginal cancer, run by Frantz Viral Therapeutics, LLC, now recruiting.","summary":"Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3) is a phase 2 interventional study registered as NCT04098744 by Frantz Viral Therapeutics, LLC, with 78 participants planned, started 2020-09-09 and due to reach its primary completion in 2026-07-31. Interventions recorded: Artesunate vaginal insert and Placebo vaginal insert.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04098744","url":"https://clinicaltrials.gov/study/NCT04098744"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["vaginal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["frantz-viral-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04098744","phase":"2","setting":"A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)","sponsor":"Frantz Viral Therapeutics, LLC","started":"2020-09-09","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"artistic-meta-analysis","kind":"trial","name":"ARTISTIC meta-analysis","aka":["ARTISTIC","Adjuvant Radiotherapy Timing In Selected Treatment Individuals after Prostatectomy Consortium"],"tldr":"Three trials asked the same question and none was big enough alone. Pooling them, planned in advance so nobody could cherry-pick, showed that waiting for the PSA to rise is as good as treating everyone.","summary":"The ARTISTIC collaboration is a model of how to settle a question that no single trial can answer. The investigators of RADICALS-RT, RAVES and GETUG-AFU 17 agreed a harmonised definition of event-free survival and registered a protocol on PROSPERO before any of the trial results were known, so the pooling could not be shaped by what came out.\n\nEvent-free survival was defined as the time from randomisation to the first of biochemical progression (PSA of 0.4 ng/mL or more and rising after any postoperative radiotherapy), clinical or radiological progression, start of a non-trial treatment, death from prostate cancer, or a PSA of at least 2.0 ng/mL at any time. Updated results were obtained for 2,153 men recruited between November 2007 and December 2016, 1,075 assigned adjuvant radiotherapy and 1,078 a policy of early salvage radiotherapy, of whom 421 (39.1 percent) had started treatment at the time of analysis. Median follow-up ranged from 60 to 78 months. Median age was 64 or 65 across trials and 1,671 men (77.6 percent) had a Gleason score of 7. All three trials were assessed as at low risk of bias.\n\nOn 270 events there was no evidence that adjuvant radiotherapy improved event-free survival: hazard ratio 0.95 (95 percent confidence interval 0.75 to 1.21, p=0.70), a change in 5-year event-free survival of 1 percentage point (-2 to 3), 89 against 88 percent. Results were consistent across trials (heterogeneity p=0.18, I-squared 42 percent).\n\nThe conclusion, that early salvage treatment is preferable because it spares many men radiotherapy and its side effects, is the practice today. The honest caveat the authors made is that long-term outcomes, including metastasis and death, are still awaited.","status":"negative","asOf":"2026-09-25","links":[{"label":"ARTISTIC prospectively planned meta-analysis (Lancet 2020)","url":"https://doi.org/10.1016/S0140-6736(20)31952-8"},{"label":"PROSPERO CRD42019132669","url":"https://www.crd.york.ac.uk/PROSPERO/view/132669"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk","prostate-bcr"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["mrc-ctu"],"institutions":[],"pathways":[],"terms":["prostatectomy","salvage-therapy","biochemical-recurrence","neoadjuvant-adjuvant"],"trials":["radicals-rt","raves","getug-afu-17","swog-8794","eortc-22911"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"observational","setting":"Prospectively planned systematic review and meta-analysis of the three randomised trials comparing immediate adjuvant radiotherapy with early salvage radiotherapy after radical prostatectomy, using a harmonised definition of event-free survival agreed before any trial reported","sponsor":"MRC Clinical Trials Unit at UCL, funded by the UK Medical Research Council","result":"Event-free survival hazard ratio 0.95 (95 percent confidence interval 0.75 to 1.21, p=0.70) for adjuvant against early salvage radiotherapy, a 1 percentage point difference at 5 years (89 against 88 percent), across 2,153 men in three trials.","yearReported":2020,"enrolled":2153,"enrolledBasis":"analysed","enrolledNote":"Aggregate data on 2,153 men from three randomised trials; it is a prospectively planned meta-analysis, not a trial with its own registration. Registered on PROSPERO as CRD42019132669.","outcomes":[{"endpoint":"Event-free survival","primary":true,"unit":"%","arms":[{"name":"Adjuvant radiotherapy","n":1075,"value":89,"note":"5-year event-free survival"},{"name":"Policy of early salvage radiotherapy","n":1078,"value":88}],"hr":0.95,"ci":[0.75,1.21],"p":"0.70","source":"https://doi.org/10.1016/S0140-6736(20)31952-8"}]},{"id":"nct04829604","kind":"trial","name":"ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)","aka":["ACE-Breast-03"],"tldr":"A phase 2 trial of ARX788 in HER2-positive breast cancer, run by Ambrx, Inc., active and no longer recruiting.","summary":"ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03) is a phase 2 interventional study registered as NCT04829604 by Ambrx, Inc., with 72 participants enrolled, started 2021-10-26 and due to reach its primary completion in 2026-12. Interventions recorded: ARX788.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04829604","url":"https://clinicaltrials.gov/study/NCT04829604"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc","site-specific-conjugation"],"targets":[],"drugs":["arx788"],"companies":["ambrx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04829604","phase":"2","setting":"A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd","sponsor":"Ambrx, Inc.","started":"2021-10-26","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01828099","kind":"trial","name":"ASCEND-4","aka":["CLDK378A2301","LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer"],"tldr":"ASCEND-4 showed that ceritinib, a second-generation ALK pill, kept untreated ALK-positive lung cancer under control about twice as long as platinum chemotherapy, though stomach and gut side effects were common.","summary":"ASCEND-4 was an open-label, randomised phase 3 trial at 134 centres in 28 countries that compared ceritinib with platinum-based chemotherapy in 376 patients with untreated stage IIIB or IV ALK-rearranged non-squamous non-small-cell lung cancer. Patients received ceritinib 750 mg once daily (189) or cisplatin or carboplatin plus pemetrexed for four cycles followed by pemetrexed maintenance (187). Randomisation was stratified by performance status, previous neoadjuvant or adjuvant chemotherapy and brain metastases, and the primary endpoint was progression-free survival by blinded independent review.\n\nMedian progression-free survival was 16.6 months with ceritinib against 8.1 months with chemotherapy (hazard ratio 0.55, 95% CI 0.42 to 0.73; The Lancet 2017). By independent review 72.5 percent of patients responded on ceritinib against 26.7 percent on chemotherapy, and responses lasted a median of 23.9 against 11.1 months (registry results; the US label rounds these to 73 and 27 percent). Among 55 patients with measurable brain metastases, intracranial responses were seen in 57 percent against 22 percent (28 and 27 patients, US label). Overall survival did not differ significantly at the prespecified interim analysis at 42 percent of required events. Gastrointestinal effects dominated ceritinib's toxicity: diarrhoea in 85 percent, nausea in 69 percent, vomiting in 66 percent and raised alanine aminotransferase in 60 percent.\n\nThe trial supported the 2017 US first-line approval of ceritinib. It compared ceritinib with chemotherapy, not with crizotinib; ALEX, ALTA-1L and CROWN later tested newer ALK inhibitors against crizotinib, and those drugs displaced ceritinib first line.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01828099","url":"https://clinicaltrials.gov/study/NCT01828099"},{"label":"The Lancet 2017","url":"https://doi.org/10.1016/S0140-6736(17)30123-X"},{"label":"Zykadia label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fff5d805-4ffd-4e8e-8e63-6f129697563e"}],"tags":[],"related":["alex","alta-1l","crown"],"cancers":["nsclc","alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["ceritinib","pemetrexed","cisplatin","carboplatin"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":["brain-metastases","tki-term"],"trials":[],"people":["jean-charles-soria","luis-paz-ares","juergen-wolf","chong-jen-yu"],"bottlenecks":[],"keyPapers":["paper-ascend-4-lancet-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01828099","phase":"3","setting":"Untreated advanced ALK-rearranged non-squamous non-small-cell lung cancer: ceritinib versus platinum and pemetrexed chemotherapy","sponsor":"Novartis Pharmaceuticals","result":"Median progression-free survival 16.6 vs 8.1 months (hazard ratio 0.55, blinded independent review); response rate 72.5% vs 26.7%; overall survival not significantly different at the interim analysis.","started":"2013-07-09","startedType":"actual","yearReported":2017,"enrolled":376,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (blinded independent review)","primary":true,"unit":"months","arms":[{"name":"Ceritinib","n":189,"value":16.6},{"name":"Platinum and pemetrexed chemotherapy","n":187,"value":8.1}],"hr":0.55,"ci":[0.42,0.73],"source":"https://doi.org/10.1016/S0140-6736(17)30123-X"},{"endpoint":"Objective response rate (blinded independent review)","unit":"%","arms":[{"name":"Ceritinib","n":189,"value":72.5},{"name":"Platinum and pemetrexed chemotherapy","n":187,"value":26.7}],"source":"https://clinicaltrials.gov/study/NCT01828099?tab=results"},{"endpoint":"Duration of response (blinded independent review)","unit":"months","arms":[{"name":"Ceritinib","n":137,"value":23.9,"note":"Responders only"},{"name":"Platinum and pemetrexed chemotherapy","n":50,"value":11.1,"note":"Responders only"}],"source":"https://clinicaltrials.gov/study/NCT01828099?tab=results"}],"replication":"No other trial compared ceritinib with chemotherapy first line; ALEX, ALTA-1L and CROWN compared newer ALK inhibitors with crizotinib instead."},{"id":"ascende-rt","kind":"trial","name":"ASCENDE-RT","aka":["ASCENDE-RT","Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy"],"tldr":"Adding radioactive seeds inside the prostate on top of external radiotherapy halves the chance that the PSA comes back, but it does not make men live longer and it costs more urinary side effects.","summary":"ASCENDE-RT enrolled 398 men, median age 68, of whom 69 percent had high-risk disease. All received 12 months of androgen deprivation and 46 Gy to the pelvis. They were then randomised to a dose-escalated external beam boost to 78 Gy or to a low-dose-rate prostate brachytherapy boost.\n\nIn the intention-to-treat analysis at a median 6.5 years, men randomised to the external beam boost were twice as likely to have biochemical failure: multivariable hazard ratio 2.04, p=0.004. Kaplan-Meier biochemical progression-free survival at 5, 7 and 9 years was 89, 86 and 83 percent with the brachytherapy boost against 84, 75 and 62 percent with the external beam boost (log-rank p<0.001). The benefit held in both intermediate-risk and high-risk men, and because the curves diverge sharply after 4 years the gap should widen with longer follow-up.\n\nNo overall survival difference was seen: multivariable hazard ratio 1.13, p=0.62. On multivariable analysis only age (hazard ratio 1.06 per year, p=0.004) and biochemical failure itself (6.30, p<0.001) predicted death. The trial therefore proves that a brachytherapy boost controls PSA better and does not prove that it saves lives, which, together with its genitourinary toxicity, is why it is offered as an option rather than as the default.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00175396","url":"https://clinicaltrials.gov/study/NCT00175396"},{"label":"ASCENDE-RT survival endpoints (International Journal of Radiation Oncology Biology Physics 2017)","url":"https://doi.org/10.1016/j.ijrobp.2016.11.026"},{"label":"NICE NG131: prostate cancer: diagnosis and management","url":"https://www.nice.org.uk/guidance/ng131"}],"tags":[],"related":[],"cancers":["prostate","prostate-intermediate-risk","prostate-high-risk"],"sections":[],"technologies":["ldr-seed-brachytherapy","brachytherapy","imrt-igrt","androgen-deprivation"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["brachytherapy-term","adt","curative-intent","biochemical-recurrence"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00175396","phase":"3","setting":"Intermediate-risk and high-risk localised prostate cancer, 69 percent high risk: 12 months of androgen deprivation and 46 Gy pelvic radiotherapy for everyone, then either a dose-escalated external beam boost to 78 Gy or a low-dose-rate prostate brachytherapy boost, with biochemical progression-free survival as the primary endpoint","sponsor":"British Columbia Cancer Agency","result":"Nine-year biochemical progression-free survival 83 percent with a low-dose-rate brachytherapy boost against 62 percent with a dose-escalated external beam boost (multivariable hazard ratio for failure 2.04, p=0.004); no overall survival difference (1.13, p=0.62).","started":"2004-05","yearReported":2017,"enrolled":398,"enrolledBasis":"randomised","enrolledNote":"398 men were randomised, 200 to the external beam boost and 198 to the brachytherapy boost.","outcomes":[{"endpoint":"Biochemical progression-free survival at 9 years","primary":true,"unit":"%","arms":[{"name":"Low-dose-rate brachytherapy boost","n":198,"value":83},{"name":"Dose-escalated external beam boost to 78 Gy","n":200,"value":62}],"p":"<0.001","source":"https://doi.org/10.1016/j.ijrobp.2016.11.026"},{"endpoint":"Overall survival","arms":[{"name":"Low-dose-rate brachytherapy boost","n":198,"note":"Multivariable hazard ratio; no significant difference."},{"name":"Dose-escalated external beam boost to 78 Gy","n":200}],"hr":1.13,"p":"0.62","source":"https://doi.org/10.1016/j.ijrobp.2016.11.026"}],"replication":"Not replicated in a second randomised trial with a survival endpoint; the brachytherapy boost is recommended as an option in guidelines on the strength of this trial alone."},{"id":"ascent","kind":"trial","name":"ASCENT","aka":[],"tldr":"The trial that proved a TROP2 ADC could nearly double survival in heavily pretreated triple-negative breast cancer.","summary":"ASCENT, trial NCT02574455 sponsored by Gilead through Immunomedics and published in the New England Journal of Medicine in 2020, proved that the TROP2 antibody-drug conjugate sacituzumab govitecan could nearly double survival in heavily pretreated metastatic triple-negative breast cancer. It randomised 529 patients with at least two prior lines to sacituzumab govitecan or chemotherapy, met its primary progression-free survival endpoint in patients without brain metastases and showed a large overall survival benefit with a much higher response rate, regardless of TROP2 expression level, which shaped the view that immunohistochemistry selection is unnecessary for TROP2 ADCs. Whether TROP2 ADCs work equally well after other topoisomerase payloads is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT02574455","url":"https://clinicaltrials.gov/study/NCT02574455"},{"label":"ASCENT primary analysis (NEJM 2021)","url":"https://doi.org/10.1056/NEJMoa2028485"},{"label":"ASCENT subgroup analyses (npj Breast Cancer 2024)","url":"https://doi.org/10.1038/s41523-024-00635-5"},{"label":"NICE TA819 (17 August 2022)","url":"https://www.nice.org.uk/guidance/ta819"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["trop2"],"drugs":["sacituzumab-govitecan"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":["ascent-03","ascent-04","keynote-119"],"people":["aditya-bardia"],"bottlenecks":[],"keyPapers":["paper-bardia-ascent-trop2-biomarker-ann-oncol-2021","paper-ascent-nejm-2021"],"journals":[],"dependsOn":[],"notes":["Design (NEJM 2021): 529 patients with relapsed or refractory metastatic triple-negative disease after at least two prior therapies randomised 1 to 1 to sacituzumab govitecan 10 mg/kg on days 1 and 8 of 21 or physician's choice of eribulin, vinorelbine, capecitabine or gemcitabine; 468 without brain metastases formed the primary population. Progression-free survival 5.6 versus 1.7 months (hazard ratio 0.41), overall survival 12.1 versus 6.7 months (0.48), response 35 versus 5 percent; grade 3 or higher neutropenia 51 versus 33 percent, diarrhoea 10 versus below 1 percent. Post hoc subgroups (npj Breast Cancer 2024): benefit held in patients aged 65 or over and in Black patients; among the 12 percent with stable brain metastases progression-free survival was numerically longer but overall survival similar.","UK sites (registry, 11): Colchester, University Hospital Coventry, University Hospital of North Durham, Royal Surrey Guildford, Hereford County Hospital, Royal Free London, the Christie, Nottingham City Hospital, Derriford Plymouth, Musgrove Park Taunton, Pinderfields Wakefield. NICE TA819 (17 August 2022) commissions the drug after two or more therapies."],"nct":"NCT02574455","phase":"3","setting":"Pretreated metastatic TNBC: sacituzumab govitecan vs chemotherapy","sponsor":"Gilead (Immunomedics)","result":"OS 12.1 vs 6.7 months, HR 0.48.","started":"2017-11-07","startedType":"actual","yearReported":2020,"enrolled":529,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (patients without brain metastases)","primary":true,"unit":"months","arms":[{"name":"Sacituzumab govitecan","n":235,"value":5.6},{"name":"Chemotherapy (TPC)","n":233,"value":1.7}],"hr":0.41,"ci":[0.32,0.52],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2028485"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Sacituzumab govitecan","value":12.1},{"name":"Chemotherapy (TPC)","value":6.7}],"hr":0.48,"ci":[0.38,0.59],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2028485"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Sacituzumab govitecan","value":35},{"name":"Chemotherapy (TPC)","value":5}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2028485"}],"replication":"Consistent with the single-arm IMMU-132-01 basket (ORR 33%) that led to accelerated approval, with TROPiCS-02 in HR+ disease, and with the first-line ASCENT-03/04 results; real-world series report similar PFS."},{"id":"ascent-03","kind":"trial","name":"ASCENT-03","aka":[],"tldr":"Moved Trodelvy into first-line use for triple-negative patients who cannot receive immunotherapy.","summary":"ASCENT-03, trial NCT05382299 sponsored by Gilead and reported at ESMO 2025, moved sacituzumab govitecan into first-line use for metastatic triple-negative breast cancer patients who cannot receive PD-1 inhibitors. It randomised 558 patients to sacituzumab govitecan or chemotherapy, met its primary progression-free survival endpoint by blinded review, and led to FDA approval of first-line monotherapy in 2026, with overall survival immature at the first analysis and crossover to sacituzumab permitted on progression. OnCo links it to triple-negative breast cancer, sacituzumab govitecan, the TNBC and TROP2 ADC roadmaps and the ASCENT paper, and it is consistent with ASCENT and with TROPION-Breast02, which tested datopotamab deruxtecan in the same population. How to choose between the two TROP2 ADCs, which have never been compared directly, is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05382299","url":"https://clinicaltrials.gov/study/NCT05382299"},{"label":"ASCENT-03 (NEJM 2025)","url":"https://doi.org/10.1056/NEJMoa2511734"},{"label":"Trodelvy label (openFDA): ASCENT-03 study section","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22TRODELVY%22"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-ascent-03-n-engl-j-med-2025"],"journals":[],"dependsOn":[],"notes":["Primary paper (NEJM 2025): 558 patients not candidates for PD-1 or PD-L1 inhibitors (99.5 percent CPS below 10) randomised 1 to 1; progression-free survival 9.7 versus 6.9 months (hazard ratio 0.62), confirmed response 48 versus 46 percent with a median duration of 12.2 versus 7.2 months; grade 3 or higher adverse events 66 versus 62 percent, discontinuation 4 versus 12 percent; 51 percent of patients had died at the label's data cut with overall survival immature. UK sites (registry, 3): Leeds Teaching Hospitals, Barts Health, University College London Hospitals. NICE appraisal GID-TA11489 awaiting development; EU indication listed in September 2026."],"nct":"NCT05382299","phase":"3","setting":"First-line metastatic TNBC, not candidates for PD-1 inhibitors: sacituzumab govitecan vs chemotherapy","sponsor":"Gilead","result":"PFS HR 0.62.","started":"2022-07-20","startedType":"actual","yearReported":2025,"enrolled":558,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 623 participants (actual); the NEJM 2025 primary analysis covered 558 randomised patients.","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Sacituzumab govitecan","n":279,"value":9.7},{"name":"Chemotherapy (TPC)","n":279,"value":6.9}],"hr":0.62,"ci":[0.5,0.77],"p":"<0.0001","source":"https://dailyreporter.esmo.org/esmo-congress-2025/breast-cancer/survival-improvements-observed-with-first-line-antibody-drug-conjugates-in-triple-negative-breast-cancer"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Sacituzumab govitecan","value":48},{"name":"Chemotherapy (TPC)","value":44}]},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Sacituzumab govitecan","note":"Immature at the primary analysis; crossover to sacituzumab permitted on progression."},{"name":"Chemotherapy (TPC)"}]}],"replication":"Consistent with ASCENT (later line) and with TROPION-Breast02 (a different TROP2 ADC in the same first-line PD-1-ineligible population), which strengthens the class effect."},{"id":"ascent-04","kind":"trial","name":"ASCENT-04 / KEYNOTE-D19","aka":[],"tldr":"Showed that pairing an ADC with immunotherapy beats chemotherapy plus immunotherapy in first-line PD-L1-positive TNBC.","summary":"ASCENT-04, also KEYNOTE-D19, trial NCT05382286 sponsored by Gilead and Merck and reported at ESMO 2025, showed that pairing the antibody-drug conjugate sacituzumab govitecan with pembrolizumab beats chemotherapy plus pembrolizumab in first-line PD-L1-positive metastatic triple-negative breast cancer. It randomised 443 patients with a combined positive score of ten or more, met its primary progression-free survival endpoint by blinded review, showed improved time to second progression at ASCO 2026 with overall survival immature, and was approved in 2026, establishing ADC plus checkpoint inhibitor as the new first-line standard for PD-L1-positive disease. OnCo links it to triple-negative breast cancer, sacituzumab govitecan, pembrolizumab, the ADC plus checkpoint inhibitor pairing and four roadmaps. Whether the survival benefit follows is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05382286","url":"https://clinicaltrials.gov/study/NCT05382286"},{"label":"ASCENT-04/KEYNOTE-D19 (NEJM 2026)","url":"https://doi.org/10.1056/NEJMoa2508959"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan","pembrolizumab"],"companies":["gilead","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-ascent-04-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":["Primary paper (NEJM 2026): 443 patients with CPS 10 or more randomised 1 to 1 to sacituzumab govitecan with pembrolizumab or chemotherapy with pembrolizumab; progression-free survival 11.2 versus 7.8 months (hazard ratio 0.65), response 60 versus 53 percent, duration of response 16.5 versus 9.2 months, discontinuation for adverse events 12 versus 31 percent, deaths from adverse events 3 percent in each arm; overall survival immature. UK sites (registry, 8): NHS Lothian, Beatson Glasgow, Leeds, Barts, Royal Free, Guy's and St Thomas', University College London Hospitals, Nottingham. No NICE appraisal listed on 24 September 2026."],"nct":"NCT05382286","phase":"3","setting":"First-line PD-L1+ (CPS ≥10) metastatic TNBC: sacituzumab govitecan + pembrolizumab vs chemotherapy + pembrolizumab","sponsor":"Gilead / Merck","result":"PFS HR 0.65; PFS2 improved.","started":"2022-07-25","startedType":"actual","yearReported":2025,"enrolled":443,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Sacituzumab govitecan + pembrolizumab","n":221,"value":11.2},{"name":"Chemotherapy + pembrolizumab","n":222,"value":7.8}],"hr":0.65,"ci":[0.51,0.84],"p":"0.0009","source":"https://dailyreporter.esmo.org/esmo-congress-2025/breast-cancer/survival-improvements-observed-with-first-line-antibody-drug-conjugates-in-triple-negative-breast-cancer"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Sacituzumab govitecan + pembrolizumab","value":60},{"name":"Chemotherapy + pembrolizumab","value":53}],"source":"https://doi.org/10.1056/NEJMoa2508959"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Sacituzumab govitecan + pembrolizumab","note":"Immature; PFS2 favoured the ADC arm in the ASCO 2026 update."},{"name":"Chemotherapy + pembrolizumab"}],"source":"https://doi.org/10.1056/NEJMoa2508959"}],"replication":"First trial of ADC + PD-1 in TNBC; the design mirrors EV-302 in urothelial cancer. TROPION-Breast05 (Dato-DXd + durvalumab) will be the confirmatory sibling."},{"id":"ascent-05","kind":"trial","name":"ASCENT-05 / OptimICE-RD (AFT-65, GBG 119, NSABP B-63)","aka":[],"tldr":"Tests whether giving a TROP2 ADC after surgery can cure more of the triple-negative patients whose cancer survived pre-surgery chemo-immunotherapy.","summary":"International randomised phase 3 in the highest-risk curable TNBC population: residual disease (non-pCR) after KEYNOTE-522-type neoadjuvant therapy. Primary endpoint invasive disease-free survival. If positive, it would be the first ADC in the curative TNBC setting and the KATHERINE moment for TNBC. Readout is event-driven; our estimate is 2027.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05633654","url":"https://clinicaltrials.gov/study/NCT05633654"},{"label":"OptimICE-RD design (Future Oncology 2024)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11520537/"},{"label":"OptimICE-RD design (Future Oncology 2024)","url":"https://doi.org/10.1080/14796694.2024.2357534"}],"tags":[],"related":["idea-post-neoadjuvant-adc","tropion-breast03"],"cancers":["tnbc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":["rcb","pcr","efs"],"trials":["keynote-522"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Design paper (Future Oncology 2024): AFT-65/ASCENT-05/OptimICE-RD randomises patients with residual invasive disease after neoadjuvant therapy to sacituzumab govitecan with pembrolizumab or physician's choice of pembrolizumab with or without capecitabine; primary endpoint invasive disease-free survival; registry enrolment 1,514 estimated, primary completion June 2027. UK sites (registry, 10): Hull, University Hospitals Birmingham, Clatterbridge Liverpool, Barts, Guy's, Royal Marsden, the Christie, East and North Hertfordshire (Mount Vernon), Taunton, York.","Registry status on 24 September 2026: Recruiting (registry record last updated 9 September 2026; primary completion expected June 2027)."],"nct":"NCT05633654","phase":"3","setting":"Stage II to III TNBC with residual invasive disease after neoadjuvant therapy and surgery: adjuvant sacituzumab govitecan + pembrolizumab vs pembrolizumab ± capecitabine","sponsor":"Gilead / Alliance Foundation Trials","started":"2022-12-12","startedType":"actual","enrolled":1514,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing; no results."},{"id":"ascertain-v","kind":"trial","name":"ASCERTAIN-V","aka":[],"tldr":"ASCERTAIN-V is the study behind the first all-oral AML regimen, approved in May 2026.","summary":"ASCERTAIN-V, trial NCT04657081 sponsored by Taiho Oncology and reported in 2026, is the study behind the first all-oral acute myeloid leukaemia regimen, approved in May 2026. OnCo links it to acute myeloid leukaemia, the oral decitabine and cedazuridine record, venetoclax and the pairing of venetoclax with a hypomethylating agent. The remission rate is in line with the venetoclax-azacitidine arm of VIALE-A, supporting equivalence of the oral backbone, but there is no randomised comparison, which is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04657081","url":"https://clinicaltrials.gov/study/NCT04657081"}],"tags":[],"related":[],"cancers":["aml"],"sections":[],"technologies":["epigenetic-drugs"],"targets":[],"drugs":["decitabine-cedazuridine","venetoclax"],"companies":["taiho"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04657081","phase":"1/2","setting":"Newly diagnosed AML unfit for intensive induction: oral decitabine-cedazuridine + venetoclax","sponsor":"Taiho Oncology","result":"CR 41.6%; median time to CR 2 months.","started":"2021-02-09","startedType":"actual","yearReported":2026,"enrolled":101,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete remission","primary":true,"unit":"%","arms":[{"name":"Decitabine-cedazuridine + venetoclax","n":101,"value":41.6}],"source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute"}],"replication":"CR rate is in line with the VIALE-A venetoclax-azacitidine arm (36.7%), supporting equivalence of the oral backbone; no randomised comparison."},{"id":"nct05384587","kind":"trial","name":"Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia","aka":[],"tldr":"A phase 2 trial of Asciminib in chronic myeloid leukaemia, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia is a phase 2 interventional study registered as NCT05384587 by Novartis Pharmaceuticals, with 34 participants enrolled, started 2022-11-11 and due to reach its primary completion in 2025-08-13. Interventions recorded: asciminib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05384587","url":"https://clinicaltrials.gov/study/NCT05384587"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cml","cml-chronic-phase"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["asciminib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05384587","phase":"2","setting":"A Phase II Multicenter, Open-label, Single-arm Dose Escalation Study of Asciminib Monotherapy in 2nd and 1st Line Chronic Phase - Chronic Myelogenous Leukemia (ASC2ESCALATE)","sponsor":"Novartis Pharmaceuticals","started":"2022-11-11","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"ascot-jcog1202","kind":"trial","name":"ASCOT (JCOG1202)","aka":["ASCOT","JCOG1202"],"tldr":"In Japan, six months of the oral chemotherapy S-1 after surgery for bile duct, gallbladder or ampullary cancer improved three-year survival from 68 to 77 percent. S-1 is not licensed for this use in the UK or Europe, so the result cannot be applied directly to NHS patients.","summary":"ASCOT (JCOG1202, UMIN000011688) randomised 440 patients between 2013 and 2018 (218 to S-1, 222 to observation) after resection of biliary tract cancer, including gallbladder carcinoma, with no or only microscopic residual tumour. S-1 (tegafur, gimeracil and oteracil) was given at 40 to 60 mg twice daily for four weeks of every six for four cycles. At a median follow-up of 45.4 months, three-year overall survival was 77.1 percent with S-1 versus 67.6 percent with observation (adjusted hazard ratio 0.69, 95 percent confidence interval 0.51 to 0.94, one-sided p 0.0080), meeting the primary endpoint; three-year relapse-free survival was 62.4 versus 50.9 percent (hazard ratio 0.80, 0.61 to 1.04). Grade 3 to 4 neutropenia occurred in 14 percent and biliary tract infection in 7 percent of the S-1 group. The trial makes S-1 the Japanese adjuvant standard alongside capecitabine from BILCAP; the two have not been compared. In Europe S-1 (Teysuno) is licensed only for gastric cancer, and it is not commissioned for biliary cancer in the UK, so capecitabine remains the NHS adjuvant drug. Gallbladder carcinoma was an eligible site and a stratification factor (primary tumour site), but a gallbladder-specific effect is not reported in the abstract.","status":"positive","asOf":"2026-09-24","links":[{"label":"Nakachi et al., Lancet 2023: adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT)","url":"https://doi.org/10.1016/S0140-6736(22)02038-4"},{"label":"UMIN000011688","url":"https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013683"}],"tags":["registry:umin"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","extrahepatic-cholangiocarcinoma","intrahepatic-cholangiocarcinoma","ampullary","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["tegafur-gimeracil-oteracil"],"companies":["jcog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registered with the UMIN Clinical Trials Registry as UMIN000011688; no ClinicalTrials.gov entry."],"phase":"3","setting":"Adjuvant S-1 for four cycles versus observation after resection of extrahepatic cholangiocarcinoma, gallbladder carcinoma, ampullary carcinoma or intrahepatic cholangiocarcinoma (R0 or R1), 38 Japanese hospitals","sponsor":"Japan Clinical Oncology Group","result":"3-year overall survival 77.1% vs 67.6%, adjusted HR 0.69 (0.51 to 0.94), one-sided p=0.0080.","yearReported":2023,"enrolled":440,"enrolledBasis":"registry","outcomes":[{"endpoint":"3-year overall survival","primary":true,"unit":"%","arms":[{"name":"S-1","n":218,"value":77.1},{"name":"Observation","n":222,"value":67.6}],"hr":0.69,"ci":[0.51,0.94],"p":"0.0080 (one-sided)","source":"https://doi.org/10.1016/S0140-6736(22)02038-4"},{"endpoint":"3-year relapse-free survival","unit":"%","arms":[{"name":"S-1","n":218,"value":62.4},{"name":"Observation","n":222,"value":50.9}],"hr":0.8,"ci":[0.61,1.04],"p":"0.088","source":"https://doi.org/10.1016/S0140-6736(22)02038-4"}]},{"id":"nct04639986","kind":"trial","name":"Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)","aka":[],"tldr":"A phase 3 trial of Sacituzumab govitecan, Eribulin, Capecitabine, Gemcitabine and Vinorelbine in advanced solid tumours, run by Gilead Sciences, active and no longer recruiting.","summary":"Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) is a phase 3 interventional study registered as NCT04639986 by Gilead Sciences, with 331 participants enrolled, started 2020-11-23 and due to reach its primary completion in 2026-12. Interventions recorded: Sacituzumab Govitecan-hziy, Eribulin Mesylate Injection, Capecitabine Oral Product, Gemcitabine Injection and Vinorelbine injection.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04639986","url":"https://clinicaltrials.gov/study/NCT04639986"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan","eribulin","capecitabine","gemcitabine","vinorelbine"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04639986","phase":"3","setting":"A Phase 3 Asian Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer (MBC) Who Have Failed at Least 2 Prior Chemotherapy Regimens","sponsor":"Gilead Sciences","started":"2020-11-23","startedType":"actual","enrolled":331,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04143607","kind":"trial","name":"ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC","aka":[],"tldr":"A phase 3 trial of Limertinib run by Jiangsu Aosaikang Pharmaceutical Co., Ltd., active.","summary":"ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC is a phase 3 interventional study registered as NCT04143607 by Jiangsu Aosaikang Pharmaceutical Co., Ltd., with 337 participants enrolled, started 2019-07-23. Conditions listed: Locally Advanced or Metastatic NSCLC. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04143607","url":"https://clinicaltrials.gov/study/NCT04143607"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["limertinib"],"companies":["aosaikang-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04143607-lancet-respir-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04143607","phase":"3","setting":"A Phase III,Double-Blind, Randomised Study to Assess the Efficacy and Safety of ASK120067 Versus Gefitinib as First-Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Jiangsu Aosaikang Pharmaceutical Co., Ltd.","started":"2019-07-23","startedType":"actual","enrolled":337,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05632939","kind":"trial","name":"ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable G/GEJ Cancer.","aka":[],"tldr":"A phase 1/2 trial of CAPOX, Sintilimab, Tislelizumab in oesophageal cancer, run by AskGene Pharma, Inc., active and no longer recruiting.","summary":"ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable G/GEJ Cancer. is a phase 1/2 interventional study registered as NCT05632939 by AskGene Pharma, Inc., with 62 participants enrolled, started 2023-02-21 and due to reach its primary completion in 2025-10-31. Interventions recorded: ASKB589 +CAPOX+Sintilimab/Tislelizumab. Conditions listed: Gastric Cancer, Gastroesophageal Cancer (GC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05632939","url":"https://clinicaltrials.gov/study/NCT05632939"}],"tags":["ctgov-ingest"],"related":[],"cancers":["esophageal","oesophageal-adenocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["capox","sintilimab","tislelizumab"],"companies":["askgene-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05632939","phase":"1/2","setting":"A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable Gastric/Esophagogastric Junction Cancer.","sponsor":"AskGene Pharma, Inc.","started":"2023-02-21","startedType":"actual","enrolled":62,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07109531","kind":"trial","name":"ASKC202 Combined With Limertinib Versus Platinum-based Chemotherapy in Treatment of Locally Advanced or Metastatic NSCLC With MET Amplification/Overexpression After Failure of EGFR-TKI Therapy","aka":[],"tldr":"A phase 3 trial of Limertinib, Carboplatin, Cisplatin and Pemetrexed in non-small-cell lung cancer, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd., now recruiting.","summary":"ASKC202 Combined With Limertinib Versus Platinum-based Chemotherapy in Treatment of Locally Advanced or Metastatic NSCLC With MET Amplification/Overexpression After Failure of EGFR-TKI Therapy is a phase 3 interventional study registered as NCT07109531 by Jiangsu Aosaikang Pharmaceutical Co., Ltd., with 286 participants planned, started 2025-08-04 and due to reach its primary completion in 2027-10-31. Interventions recorded: ASKC202+ Limertinib and Pemetrexed + Cisplatin /Carboplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07109531","url":"https://clinicaltrials.gov/study/NCT07109531"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["limertinib","carboplatin","cisplatin","pemetrexed"],"companies":["aosaikang-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07109531","phase":"3","setting":"A Randomized, Controlled, Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of ASKC202 in Combination With Limertinib Versus Platinum-based Chemotherapy in Participants With MET Amplification/Overexpression Locally Advanced or Metastatic NSCLC Who Have Failed After Prior EGFR-TKI Therapy.","sponsor":"Jiangsu Aosaikang Pharmaceutical Co., Ltd.","started":"2025-08-04","startedType":"actual","enrolled":286,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03769506","kind":"trial","name":"ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy","aka":[],"tldr":"A phase 3 trial of ASP-1929 Photoimmunotherapy in head and neck squamous cell carcinoma, run by Rakuten Medical, Inc., active and no longer recruiting.","summary":"ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy is a phase 3 interventional study registered as NCT03769506 by Rakuten Medical, Inc., with 135 participants enrolled, started 2019-05-09 and due to reach its primary completion in 2025-12. Interventions recorded: ASP-1929 Photoimmunotherapy and Physician's Choice SOC.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03769506","url":"https://clinicaltrials.gov/study/NCT03769506"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["rakuten-medical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03769506","phase":"3","setting":"A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy, of Which at Least One Line Must Be Systemic Therapy","sponsor":"Rakuten Medical, Inc.","started":"2019-05-09","startedType":"actual","enrolled":135,"enrolledBasis":"registry","outcomes":[]},{"id":"aspen-wm","kind":"trial","name":"ASPEN (Waldenström macroglobulinaemia)","aka":["ASPEN","BGB-3111-302"],"tldr":"ASPEN compared two BTK inhibitors head to head in Waldenström macroglobulinaemia: zanubrutinib did not produce statistically more deep responses than ibrutinib, but it caused far fewer heart rhythm problems and other side effects, which is why many guidelines now prefer it.","summary":"ASPEN randomised 201 patients with MYD88-mutated Waldenström macroglobulinaemia to zanubrutinib or ibrutinib, the first head-to-head comparison of BTK inhibitors in any disease. The primary endpoint was the rate of complete or very good partial response. A third, non-randomised cohort treated MYD88 wild-type patients with zanubrutinib.\n\nThe rate of complete or very good partial response was numerically higher with zanubrutinib but the difference was not statistically significant, so the primary endpoint was not met. Zanubrutinib caused substantially less atrial fibrillation, bleeding, diarrhoea and hypertension, and fewer patients stopped it for toxicity. On the strength of efficacy and tolerability it was approved in the United States for Waldenström macroglobulinaemia in 2021. Not to be confused with the ASPEN trial of everolimus versus sunitinib in non-clear-cell kidney cancer.","status":"mixed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03053440","url":"https://clinicaltrials.gov/study/NCT03053440"}],"tags":["subtype-trials"],"related":[],"cancers":["waldenstrom","non-hodgkin-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["zanubrutinib","ibrutinib"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["constantine-tam"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03053440","phase":"3","setting":"Waldenström macroglobulinaemia with a MYD88 mutation, untreated or relapsed: zanubrutinib against ibrutinib, with a separate cohort of MYD88 wild-type disease on zanubrutinib","sponsor":"BeiGene (BeOne Medicines)","result":"Zanubrutinib did not significantly increase the complete or very good partial response rate over ibrutinib, but had markedly less cardiovascular and other toxicity; approved for Waldenström macroglobulinaemia in 2021.","started":"2017-01-25","startedType":"actual","yearReported":2020,"enrolled":201,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response or very good partial response by independent review, MYD88-mutated cohort (registry results)","primary":true,"unit":"%","arms":[{"name":"Zanubrutinib","value":28.4,"note":"95% CI 19.9 to 38.2"},{"name":"Ibrutinib","value":19.2,"note":"95% CI 12.0 to 28.3"}],"p":"0.0921","source":"https://clinicaltrials.gov/study/NCT03053440?tab=results"}]},{"id":"nct07007559","kind":"trial","name":"ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer","aka":["ASPEN-09-03"],"tldr":"A phase 2 trial of Evorpacept, Trastuzumab, Capecitabine, Eribulin, Gemcitabine and Vinorelbine in HER2-positive breast cancer, run by ALX Oncology Inc., now recruiting.","summary":"ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer is a phase 2 interventional study registered as NCT07007559 by ALX Oncology Inc., with 120 participants planned, started 2025-12-10 and due to reach its primary completion in 2027-12. Interventions recorded: Evorpacept (ALX148), Trastuzumab, Paclitaxel, Capecitabine, Eribulin and Gemcitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07007559","url":"https://clinicaltrials.gov/study/NCT07007559"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["cd47-blockade","monoclonal-antibody"],"targets":[],"drugs":["evorpacept","trastuzumab","capecitabine","eribulin","gemcitabine","vinorelbine"],"companies":["alx-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07007559","phase":"2","setting":"Protocol ASPEN-09-03: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Participants With Metastatic HER2-Positive Breast Cancer, a Substudy Under Master Protocol ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies","sponsor":"ALX Oncology Inc.","started":"2025-12-10","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03326791","kind":"trial","name":"Aspirin in Colorectal Cancer Liver Metastases","aka":["ASAC"],"tldr":"A phase 2/3 trial of aspirin in colorectal cancer, run by Oslo University Hospital, active but no longer recruiting.","summary":"Aspirin in Colorectal Cancer Liver Metastases is a phase 2/3, randomised interventional study registered as NCT03326791 by Oslo University Hospital, with a registry enrolment figure of 466 participants, started 2017-12-15 and due to reach its primary completion in 2022-02-01. Interventions recorded: Acetylsalicylic acid; Placebo Oral Tablet. Conditions listed: Colorectal Cancer Liver Metastases; Colorectal Cancer; Liver Metastases. Primary outcome: Disease Free Survival (DFS) after three years treatment. Sites: Denmark, Norway, Sweden. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03326791","url":"https://clinicaltrials.gov/study/NCT03326791"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["aspirin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03326791","phase":"2/3","setting":"Acetylsalicylic Acid as Secondary Prevention in Colorectal Cancer","sponsor":"Oslo University Hospital","started":"2017-12-15","startedType":"actual","enrolled":466,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03464305","kind":"trial","name":"ASPIRIN Trial Belgium","aka":["ASPIRIN"],"tldr":"A phase 3 trial of aspirin in colorectal cancer, run by University Hospital, Antwerp, active but no longer recruiting.","summary":"ASPIRIN Trial Belgium is a phase 3, randomised interventional study registered as NCT03464305 by University Hospital, Antwerp, with a registry enrolment figure of 148 participants, started 2018-02-22 and due to reach its primary completion in 2027-12-31. Interventions recorded: acetylsalicylic acid; Placebo. Conditions listed: Colon Cancer. Primary outcome: 5 year overall survival. Colorectal eligibility wording from the registry: \"* Patients 45 years and older with histologically confirmed adenocarcinoma of the colon\". Sites: Belgium. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03464305","url":"https://clinicaltrials.gov/study/NCT03464305"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["aspirin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03464305","phase":"3","setting":"A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients","sponsor":"University Hospital, Antwerp","started":"2018-02-22","startedType":"actual","enrolled":148,"enrolledBasis":"registry","outcomes":[]},{"id":"aspree","kind":"trial","name":"ASPREE (ASPirin in Reducing Events in the Elderly)","aka":[],"tldr":"In healthy older people, daily low-dose aspirin did not extend disability-free life and, unexpectedly, was linked with more cancer deaths. It changed guidelines against routine aspirin in the elderly.","summary":"19,114 participants followed for a median 4.7 years. Aspirin did not reduce disability-free survival (HR 1.01) or cardiovascular events, increased major haemorrhage (HR 1.38), and was associated with higher all-cause mortality (HR 1.14, 95% CI 1.01-1.29), driven by cancer deaths (HR 1.31, 95% CI 1.10-1.56), particularly from advanced or metastatic cancers. Extended follow-up did not show a later emergence of cancer prevention. The finding contradicts long-term follow-up of earlier aspirin trials in middle-aged adults and is unexplained; hypotheses include a different effect of aspirin on established late-life cancers. It was central to the US Preventive Services Task Force 2022 decision to withdraw the recommendation for aspirin to prevent colorectal cancer.","status":"negative","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT01038583","url":"https://clinicaltrials.gov/study/NCT01038583"},{"label":"Mortality results (NEJM 2018)","url":"https://doi.org/10.1056/NEJMoa1803955"}],"tags":[],"related":[],"cancers":[],"sections":["nutrition-lifestyle","prevention"],"technologies":["aspirin-cancer-prevention","chemoprevention"],"targets":[],"drugs":["aspirin"],"companies":[],"institutions":[],"pathways":[],"terms":["hazard-ratio"],"trials":[],"people":[],"bottlenecks":["b-negative-results","b-aging-comorbidity"],"keyPapers":["paper-mcneil-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01038583","phase":"3","setting":"Community-dwelling adults aged 70+ (65+ for US Black and Hispanic participants) without cardiovascular disease, dementia or disability: aspirin 100 mg/day vs placebo","sponsor":"Monash University / NIH National Institute on Aging","result":"All-cause mortality HR 1.14; cancer mortality HR 1.31; no cancer prevention.","started":"2010-01","startedType":"actual","yearReported":2018,"enrolled":19114,"enrolledBasis":"registry","outcomes":[{"endpoint":"Death from cancer","unit":"events","arms":[{"name":"Aspirin","n":9525,"value":295},{"name":"Placebo","n":9589,"value":227}],"hr":1.31,"ci":[1.1,1.56],"source":"https://doi.org/10.1056/NEJMoa1803955"}],"replication":"Discordant with pooled long-term follow-up of cardiovascular aspirin trials in younger adults (reduced colorectal cancer mortality); age-dependence of the aspirin effect is now the working explanation."},{"id":"nct01933932","kind":"trial","name":"Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral","aka":["SELECT 1"],"tldr":"A phase 3 trial of Selumetinib, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC is a phase 3 interventional study registered as NCT01933932 by AstraZeneca, with 510 participants enrolled, started 2013-09-25 and due to reach its primary completion in 2016-06-07. Interventions recorded: Selumetinib, Docetaxel, Placebo, Pegylated G-CSF. Conditions listed: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV. Results were posted on ClinicalTrials.gov in 2017; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01933932","url":"https://clinicaltrials.gov/study/NCT01933932"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["selumetinib","docetaxel"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct01933932-jama-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01933932","phase":"3","setting":"A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, in Patients Receiving Second Line Treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT 1)","sponsor":"AstraZeneca","started":"2013-09-25","startedType":"actual","yearReported":2017,"enrolled":510,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Selumetinib + Docetaxel","n":254,"value":3.9,"note":"IQR 1.5 to 5.9; Figures from the ClinicalTrials.gov results section (first posted 2017-08-29), not from a publication"},{"name":"Placebo + Docetaxel","n":256,"value":2.8,"note":"IQR 1.4 to 5.5"}],"hr":0.93,"ci":[0.77,1.12],"p":"0.4355","source":"https://clinicaltrials.gov/study/NCT01933932?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Selumetinib + Docetaxel","n":254,"value":8.7,"note":"IQR 3.6 to 16.8; Figures from the ClinicalTrials.gov results section (first posted 2017-08-29), not from a publication"},{"name":"Placebo + Docetaxel","n":256,"value":7.9,"note":"IQR 3.8 to 20.1"}],"hr":1.05,"ci":[0.85,1.3],"p":"0.6431","source":"https://clinicaltrials.gov/study/NCT01933932?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"participants","arms":[{"name":"Selumetinib + Docetaxel","n":254,"value":51,"note":"Figures from the ClinicalTrials.gov results section (first posted 2017-08-29), not from a publication"},{"name":"Placebo + Docetaxel","n":256,"value":35}],"p":"0.0515","source":"https://clinicaltrials.gov/study/NCT01933932?tab=results"}]},{"id":"nct03847428","kind":"trial","name":"Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment","aka":["EMERALD-2"],"tldr":"A phase 3 trial of Durvalumab, Bevacizumab in hepatocellular carcinoma, run by AstraZeneca, active and no longer recruiting.","summary":"Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment is a phase 3 interventional study registered as NCT03847428 by AstraZeneca, with 908 participants enrolled, started 2019-04-29 and due to reach its primary completion in 2026-05-15. Interventions recorded: Durvalumab, Bevacizumab, Placebo. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03847428","url":"https://clinicaltrials.gov/study/NCT03847428"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-early"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["durvalumab","bevacizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03847428","phase":"3","setting":"A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation","sponsor":"AstraZeneca","started":"2019-04-29","startedType":"actual","enrolled":908,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05794750","kind":"trial","name":"Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13）","aka":["AK104-IIT-13"],"tldr":"A phase 2 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by JIN JING, not yet recruiting.","summary":"Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13） is a phase 2, interventional study registered as NCT05794750 by JIN JING, with a registry enrolment figure of 50 participants, started 2023-04-24 and due to reach its primary completion in 2027-04-24. Interventions recorded: AK104 injection; TME surgery; Capecitabine; Oxaliplatin. Conditions listed: Locally Advanced Rectal Cancer. Primary outcome: Pathologic complete response rate (pCR). Colorectal eligibility wording from the registry: \"Fiber colonoscopy or diagnosis examination, the lower boundary of the lesion is 15m ≤ from the margin;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05794750","url":"https://clinicaltrials.gov/study/NCT05794750"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05794750","phase":"2","setting":"A Single-arm, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Preoperative Short-course Radiotherapy Followed by Sequential Chemotherapy and AK104 for Locally Advanced Rectal Cancer","sponsor":"JIN JING","started":"2023-04-24","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03829462","kind":"trial","name":"Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients","aka":["NEXT-REGIRI"],"tldr":"A phase 3 trial of regorafenib and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle, active but no longer recruiting.","summary":"Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients is a phase 3, randomised interventional study registered as NCT03829462 by Institut du Cancer de Montpellier - Val d'Aurelle, with a registry enrolment figure of 377 participants, started 2019-03-28 and due to reach its primary completion in 2024-09-04. Interventions recorded: Regorafenib; Irinotecan. Conditions listed: Metastatic Colorectal Cancer (mCRC). Primary outcome: Overall Survival. Colorectal eligibility wording from the registry: \"* Histological documentation of adenocarcinoma of the colon or rectum\". Sites: France. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03829462","url":"https://clinicaltrials.gov/study/NCT03829462"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","kinase-inhibitors","topoisomerase-inhibitors"],"targets":[],"drugs":["regorafenib","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03829462","phase":"3","setting":"A Randomized Phase III Trial Assessing a Regorafenib-irinotecan Combination (REGIRI) Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients After Failure of Standard Therapies, According to the A/A Genotype of Cyclin D1","sponsor":"Institut du Cancer de Montpellier - Val d'Aurelle","started":"2019-03-28","startedType":"actual","yearReported":2025,"enrolled":377,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival","primary":true,"unit":"months","arms":[{"name":"Irinotecan + Regorafenib (REGIRI)","n":27,"value":9,"note":"95% CI 6.1 to 14.5; Figures from the ClinicalTrials.gov results section (first posted 2025-07-18), not from a publication"},{"name":"Regorafenib","n":29,"value":5.5,"note":"95% CI 3.8 to 13.4"}],"hr":1.18,"ci":[0.7,1.98],"p":"0.5334","source":"https://clinicaltrials.gov/study/NCT03829462?tab=results"},{"endpoint":"Progression-free Survival (PFS)","unit":"months","arms":[{"name":"Irinotecan + Regorafenib (REGIRI)","n":33,"value":3.6,"note":"95% CI 2 to 4.2; Figures from the ClinicalTrials.gov results section (first posted 2025-07-18), not from a publication"},{"name":"Regorafenib","n":33,"value":1.9,"note":"95% CI 1.8 to 2.1"}],"hr":0.67,"ci":[0.4,1.11],"p":"0.1104","source":"https://clinicaltrials.gov/study/NCT03829462?tab=results"},{"endpoint":"Number of Patients With an Objective Response Rate","unit":"participants","arms":[{"name":"Irinotecan + Regorafenib (REGIRI)","n":27,"value":2,"note":"Figures from the ClinicalTrials.gov results section (first posted 2025-07-18), not from a publication"},{"name":"Regorafenib","n":29,"value":0}],"source":"https://clinicaltrials.gov/study/NCT03829462?tab=results"}]},{"id":"nct03974022","kind":"trial","name":"Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)","aka":["WU-KONG1"],"tldr":"A phase 1/2 trial of Sunvozertinib in non-small-cell lung cancer and small-cell lung cancer, run by Dizal Pharmaceuticals, active and no longer recruiting.","summary":"Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) is a phase 1/2 interventional study registered as NCT03974022 by Dizal Pharmaceuticals, with 315 participants enrolled, started 2019-07-09 and due to reach its primary completion in 2024-07-29. Interventions recorded: Sunvozertinib. Conditions listed: Non-Small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03974022","url":"https://clinicaltrials.gov/study/NCT03974022"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc","her2-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["sunvozertinib"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03974022-j-clin-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03974022","phase":"1/2","setting":"A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Mutation","sponsor":"Dizal Pharmaceuticals","started":"2019-07-09","startedType":"actual","yearReported":2025,"enrolled":315,"enrolledBasis":"registry","outcomes":[{"endpoint":"Part B: Objective Response Rate (ORR) According to RECIST 1.1 by an Independent Review Committee (IRC).","primary":true,"unit":"%","arms":[{"name":"Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg","n":85,"value":45.9,"note":"97.5% CI 33.6 to 58.5; Figures from the ClinicalTrials.gov results section (first posted 2025-12-03), not from a publication"},{"name":"Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg","n":107,"value":45.8,"note":"97.5% CI 34.8 to 57.0"}],"source":"https://clinicaltrials.gov/study/NCT03974022?tab=results"}]},{"id":"nct07455903","kind":"trial","name":"Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT","aka":["LHRPC"],"tldr":"A phase 2 trial of Leuprolide, Degarelix, Relugolix, Triptorelin, Bicalutamide and Flotufolastat F-18 in Prostate cancer, run by Baptist Health South Florida, now recruiting.","summary":"Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT is a phase 2 interventional study registered as NCT07455903 by Baptist Health South Florida, with 50 participants planned, started 2026-07-29 and due to reach its primary completion in 2030-02. Interventions recorded: Leuprolide, Degarelix, Relugolix, Triptorelin, Bicalutamide, 18-F Flotufolastat PSMA PET, Radical prostatectomy. Conditions recorded: Prostate Cancer, Localized Prostate Carcinoma.\n\nLinked to the drug Flotufolastat F-18 because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07455903","url":"https://clinicaltrials.gov/study/NCT07455903"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["leuprolide","degarelix","relugolix","triptorelin","bicalutamide","flotufolastat"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07455903","phase":"2","setting":"Assessing the Efficacy of Neoadjuvant Androgen Deprivation Therapy (ADT) Utilizing 18F-Flotufolastat PSMA PET/CT in Patients With High-Risk Localized Prostate Cancer (LHRPC)","sponsor":"Baptist Health South Florida","started":"2026-07-29","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07496229","kind":"trial","name":"Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3)","aka":["BEI-DOU3"],"tldr":"A phase 1/2 trial of Golidocitinib in peripheral T-cell lymphomas, run by Dizal Pharmaceuticals, now recruiting.","summary":"Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3) is a phase 1/2 interventional study registered as NCT07496229 by Dizal Pharmaceuticals, with 165 participants planned, started 2026-04-15 and due to reach its primary completion in 2029-09. Interventions recorded: GW5282 combined with Golidocitinib and Conventional CHOP regimen.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07496229","url":"https://clinicaltrials.gov/study/NCT07496229"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["golidocitinib"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07496229","phase":"1/2","setting":"A Phase I/II Clinical Study to Evaluate the Efficacy and Safety of GW5282 in Combination With Golidocitinib in the Treatment of T-Cell Lymphoma","sponsor":"Dizal Pharmaceuticals","started":"2026-04-15","startedType":"actual","enrolled":165,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04270591","kind":"trial","name":"Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of Glumetinib in non-small-cell lung cancer, run by Haihe Biopharma Co., Ltd., now recruiting.","summary":"Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT04270591 by Haihe Biopharma Co., Ltd., with 183 participants planned, started 2019-07-15 and due to reach its primary completion in 2023-10-25. Interventions recorded: Glumetinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04270591","url":"https://clinicaltrials.gov/study/NCT04270591"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["glumetinib"],"companies":["haihe-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04270591-eclinicalmedicine-2023","paper-nct04270591-transl-lung-cancer-res-2025-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04270591","phase":"1/2","setting":"A Phase Ib/II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Glumetinib (SCC244), a Selective MET Inhibitor in Patients With Advanced Non-Small Cell Lung Cancer Harboring MET-alterations","sponsor":"Haihe Biopharma Co., Ltd.","started":"2019-07-15","startedType":"actual","enrolled":183,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03957902","kind":"trial","name":"Assessment of Direct Biomarkers of Aspirin Action to Develop a Precision Chemoprevention Therapy of Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of aspirin in colorectal cancer, run by Instituto de Investigación Sanitaria Aragón, now recruiting.","summary":"Assessment of Direct Biomarkers of Aspirin Action to Develop a Precision Chemoprevention Therapy of Colorectal Cancer is a phase 2, randomised interventional study registered as NCT03957902 by Instituto de Investigación Sanitaria Aragón, with a registry enrolment figure of 60 participants, started 2019-05-06 and due to reach its primary completion in 2025-05. Interventions recorded: acetylsalicylic acid. Conditions listed: Colorectal Cancer. Primary outcome: Assessment of changes in acetylation levels of COX enzymes in platelets and non-neoplastic and neoplastic colonic tissues. Colorectal eligibility wording from the registry: \"* recent diagnosis (\\< 48h) of rectum or colon cancer, established by endoscopy and later confirmed by anatomo-pathologic study\". Sites: Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03957902","url":"https://clinicaltrials.gov/study/NCT03957902"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["aspirin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03957902","phase":"2","setting":"Assessment of Direct Biomarkers of Aspirin Action to Develop a Precision Chemoprevention Therapy of Colorectal Cancer","sponsor":"Instituto de Investigación Sanitaria Aragón","started":"2019-05-06","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04590963","kind":"trial","name":"Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer","aka":["INTERLINK-1"],"tldr":"A phase 3 trial testing Monalizumab in head and neck squamous cell carcinoma, active and no longer recruiting.","summary":"Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer is a phase 3 interventional study registered as NCT04590963, led by AstraZeneca with Innate Pharma, and active but no longer recruiting on the registry. Official title: A Phase 3 Randomised, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor. Planned enrolment is 370 participants (actual). The study started in 2020-10-02 and primary completion is expected in 2022-05-11. Results have been posted on ClinicalTrials.gov; they are not yet summarised here.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04590963","url":"https://clinicaltrials.gov/study/NCT04590963"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["monalizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04590963","phase":"3","setting":"A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor","sponsor":"AstraZeneca","started":"2020-10-02","startedType":"actual","yearReported":2023,"enrolled":370,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set","primary":true,"unit":"months","arms":[{"name":"Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2","n":145,"value":8.8,"note":"95% CI 6.9 to 10.4; Figures from the ClinicalTrials.gov results section (first posted 2023-11-18), not from a publication"},{"name":"Placebo Q2W + Cetuximab 400 mg/m^2","n":71,"value":8.6,"note":"95% CI 6.0 to 14.5"}],"hr":1,"ci":[0.66,1.537],"p":"0.989","source":"https://clinicaltrials.gov/study/NCT04590963?tab=results"},{"endpoint":"Percentage of Participants With Objective Response (OR) Per RECIST 1.1 in HPV-unrelated Analysis Set","unit":"%","arms":[{"name":"Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2","n":145,"value":15.2,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-11-18), not from a publication"},{"name":"Placebo Q2W + Cetuximab 400 mg/m^2","n":71,"value":23.9}],"p":"0.115","source":"https://clinicaltrials.gov/study/NCT04590963?tab=results"}]},{"id":"nct06220318","kind":"trial","name":"Assessment of the Safety and Efficacy of C019199 Plus Sintilimab in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Sintilimab in advanced solid tumours, run by Fujian Haixi Pharmaceuticals Co., Ltd., active and no longer recruiting.","summary":"Assessment of the Safety and Efficacy of C019199 Plus Sintilimab in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06220318 by Fujian Haixi Pharmaceuticals Co., Ltd., with 155 participants enrolled, started 2023-07-19 and due to reach its primary completion in 2026-08-30. Interventions recorded: C019199 and Sintilimab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06220318","url":"https://clinicaltrials.gov/study/NCT06220318"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06220318","phase":"1/2","setting":"A Phase I/II Clinical Study on the Safety, Tolerability and Preliminary Efficacy of C019199 in Combination With Sintilimab in Patients With Advanced Solid Tumors","sponsor":"Fujian Haixi Pharmaceuticals Co., Ltd.","started":"2023-07-19","startedType":"actual","enrolled":155,"enrolledBasis":"registry","outcomes":[]},{"id":"astra","kind":"trial","name":"ASTRA","aka":[],"tldr":"Adding a MEK inhibitor to boost iodine uptake before ablation did not improve complete remission rates, cooling the 'redifferentiation for everyone' idea.","summary":"ASTRA, trial NCT01843062 sponsored by AstraZeneca and reported in 2019, found that adding the MEK inhibitor selumetinib to boost iodine uptake before adjuvant radioiodine in high-risk differentiated thyroid cancer did not improve complete remission rates, cooling the idea of redifferentiation for everyone. It randomised 401 patients to selumetinib or placebo with radioiodine and found no difference in complete remission at eighteen months. OnCo links it to thyroid cancer, radioiodine therapy, kinase inhibitors, the MAPK pathway and the pairing of MAPK inhibitor redifferentiation followed by radioiodine. Redifferentiation remains reserved for selected radioiodine-refractory patients, where small series show MEK or BRAF and MEK inhibitors restore uptake in about half, and whether that selected use can be proved in a randomised trial is the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01843062","url":"https://clinicaltrials.gov/study/NCT01843062"},{"label":"JCO 2022","url":"https://ascopubs.org/doi/10.1200/JCO.21.00714"}],"tags":["failure","lesson:adjuvant-vs-active-disease"],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["radioiodine-therapy","kinase-inhibitors"],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":["ras-mapk"],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01843062","phase":"3","setting":"High-risk differentiated thyroid cancer: selumetinib + adjuvant radioiodine vs placebo + radioiodine","sponsor":"AstraZeneca","result":"Complete remission 40% vs 38.5%; not significant.","started":"2013-08-27","startedType":"actual","yearReported":2019,"enrolled":401,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete remission at 18 months","primary":true,"unit":"%","arms":[{"name":"Selumetinib + RAI","value":40},{"name":"Placebo + RAI","value":38.5}],"source":"https://ascopubs.org/doi/10.1200/JCO.21.00714"}],"replication":"Small redifferentiation series remain positive in refractory patients; the adjuvant setting was negative."},{"id":"nct07015853","kind":"trial","name":"ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation","aka":["ASTRAEA"],"tldr":"A phase 2 trial of pembrolizumab in triple-negative breast cancer, run by Stephen Shiao, not yet recruiting.","summary":"ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation is a phase 2, interventional study registered as NCT07015853 by Stephen Shiao, with a registry enrolment figure of 34 participants, started 2026-06 and due to reach its primary completion in 2033-07. Interventions recorded: Pembrolizumab; Radiotherapy; Axatilimab. Conditions listed: TNBC - Triple-Negative Breast Cancer; Breast Cancer. Triple-negative eligibility wording from the registry: \"* Patients with metastatic or locally recurrent TNBC who received prior immunotherapy in any setting (curative or advanced/metastatic)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07015853","url":"https://clinicaltrials.gov/study/NCT07015853"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07015853","phase":"2","setting":"IIT2024-02-SHIAO-ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation","sponsor":"Stephen Shiao","started":"2026-06","startedType":"estimated","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"astrum-005","kind":"trial","name":"ASTRUM-005","aka":[],"tldr":"In ASTRUM-005, a Chinese PD-1 antibody produced the longest first-line survival of the chemo-immunotherapy trials; it is now approved in Europe and the UK but not yet in the US.","summary":"ASTRUM-005, trial NCT04063163 sponsored by Henlius and reported in 2022, showed that the Chinese PD-1 antibody serplulimab added to first-line carboplatin and etoposide in extensive-stage small-cell lung cancer produced the longest survival of the chemo-immunotherapy trials, and it is now approved in Europe, the United Kingdom and India but not yet in the United States. It randomised 585 patients and met its primary overall survival endpoint, leading to approval in China in 2022 and in the European Union in February 2025, while a US bridging study against atezolizumab, ASTRIDE, has completed enrolment. OnCo links it to small-cell lung cancer, serplulimab, the platinum-etoposide record, Shanghai Henlius Biotech, Ying Cheng, Jilin Cancer Hospital and CAPSTONE-1. Whether cross-trial differences in effect size reflect drug or population is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04063163","url":"https://clinicaltrials.gov/study/NCT04063163"}],"tags":[],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["serplulimab","platinum-etoposide"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["cheng-ying"],"bottlenecks":[],"keyPapers":["paper-astrum-005-jama-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04063163","phase":"3","setting":"First-line ES-SCLC: serplulimab + carboplatin-etoposide vs placebo + carboplatin-etoposide","sponsor":"Henlius","result":"OS 15.4 vs 10.9 months, HR 0.63.","started":"2019-09-12","startedType":"actual","yearReported":2022,"enrolled":585,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Serplulimab + CE","n":389,"value":15.4},{"name":"Placebo + CE","n":196,"value":10.9}],"hr":0.63,"ci":[0.49,0.82],"source":"https://jamanetwork.com/journals/jama/fullarticle/2796605"}],"replication":"Consistent with IMpower133 and CASPIAN; cross-trial magnitude differences may reflect population and control-arm differences rather than drug differences."},{"id":"nct05969860","kind":"trial","name":"At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Mayo Clinic, now recruiting.","summary":"At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer is a phase 2, randomised interventional study registered as NCT05969860 by Mayo Clinic, with a registry enrolment figure of 220 participants, started 2023-08-23 and due to reach its primary completion in 2027-01-01. Interventions recorded: Clinical Encounter; Home Health Encounter; Quality-of-Life Assessment; Questionnaire Administration. Conditions listed: Advanced Anal Carcinoma; Advanced Biliary Tract Carcinoma; Advanced Bladder Carcinoma; Advanced Breast Carcinoma; Advanced Carcinoid Tumor; Advanced Cervical Carcinoma; Advanced Colorectal Carcinoma; Advanced Gastric Carcinoma; Advanced Glioblastoma; Advanced Head and Neck Carcinoma; Advanced HER2 Positive Breast Carcinoma; Advanced Lung Carcinoma; Advanced Lung Small Cell Carcinoma; Advanced Malignant Germ Cell Tumor; Advanced Malignant Solid Neoplasm; Advanced Neuroendocrine Carcinoma; Advanced Ovarian Carcinoma; Advanced Pancreatic Carcinoma; Advanced Prostate Small Cell Neuroendocrine Carcinoma; Advanced Prostate Carcinoma; Hematopoietic and Lymphoid System Neoplasm; Multiple Myeloma; Myelodysplastic Syndrome; Advanced Basal Cell Carcinoma; Advanced Cholangiocarcinoma; Advanced Endometrial Carcinoma; Advanced Esophageal Carcinoma; Advanced Fallopian Tube Carcinoma; Advanced Hepatocellular Carcinoma; Advanced Liver Carcinoma; Advanced Lymphoma; Advanced Malignant Testicular Neoplasm; Advanced Melanoma; Advanced Merkel Cell Carcinoma; Advanced Penile Carcinoma; Advanced Primary Malignant Central Nervous System Neoplasm; Advanced Renal Cell Carcinoma; Advanced Sarcoma; Advanced Skin Squamous Cell Carcinoma; Advanced Urethral Carcinoma; Advanced Vaginal Carcinoma; Advanced Vulvar Carcinoma; Advanced Appendix Carcinoma; Advanced Gastroesophageal Junction Adenocarcinoma. Primary outcome: Mean patient-reported rating of Cancer Connected Access and Remote Expertise. Pancreatic eligibility wording from the registry: \"* Pancreatic adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05969860","url":"https://clinicaltrials.gov/study/NCT05969860"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05969860","phase":"2","setting":"Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic","sponsor":"Mayo Clinic","started":"2023-08-23","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07374419","kind":"trial","name":"Atamparib in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of atamparib escalation levels in non-small-cell lung cancer, run by Nerviano Medical Sciences (Shanghai) Ltd., now recruiting.","summary":"Atamparib in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07374419 by Nerviano Medical Sciences (Shanghai) Ltd., with 178 participants planned, started 2026-03-18 and due to reach its primary completion in 2028-07-31. Interventions recorded: atamparib escalation levels and atamparib RP2D.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07374419","url":"https://clinicaltrials.gov/study/NCT07374419"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["nerviano-medical-sciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07374419","phase":"1/2","setting":"A Phase Ib/II Study of Atamparib in Patients With Advanced Solid Tumors","sponsor":"Nerviano Medical Sciences (Shanghai) Ltd.","started":"2026-03-18","startedType":"actual","enrolled":178,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02366884","kind":"trial","name":"Atavistic chemotherapy: combinations of antibacterial, antifungal and antiprotozoal drugs in advanced cancer (Arguello clinic, status unknown)","aka":[],"tldr":"A private Mexican clinic registered a trial of mixtures of antibiotics, antifungals and anti-parasite drugs, ivermectin among them, in any advanced cancer. The registry has not been updated since 2022, shows no results, and lists a primary endpoint judged partly by looking at tumours.","summary":"The study is registered by a private clinic as a phase 2 with an estimated 250 participants, started in July 2011, an estimated primary completion of December 2022 and an overall status of unknown since its last update in April 2022 (ClinicalTrials.gov NCT02366884). The antiprotozoal arm lists nitazoxanide, chloroquine, albendazole, ivermectin, mebendazole, metronidazole, praziquantel and levamisole, so any result could not be attributed to ivermectin alone (ClinicalTrials.gov NCT02366884). The primary outcome is objective clinical tumour regression at six months, with methods that include changes in signs and symptoms and visual inspection of tumours alongside imaging (ClinicalTrials.gov NCT02366884). No results are posted and the registry's reference list contains only the investigator's own animal papers from 1988 to 1998 (ClinicalTrials.gov NCT02366884).","status":"historic","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02366884","url":"https://clinicaltrials.gov/study/NCT02366884"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["fenbendazole-ivermectin-repurposing-claims"],"targets":[],"drugs":["ivermectin","mebendazole"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-misinformation"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo agent (Claude Fable 5.1)","editedOn":"2026-09-24","note":"Written from cached ClinicalTrials.gov v2, Europe PMC, DailyMed, Drugs@FDA and WHO eEML responses; no figure appears without its source link."},"nct":"NCT02366884","phase":"2","setting":"Advanced, metastatic or otherwise incurable cancers of any type after conventional treatment failed or was refused: randomised, single-blind, response-adaptive; four arms of two or six marketed anti-infective drugs, with ivermectin one of eight antiprotozoals in one arm","sponsor":"Dr. Frank Arguello Cancer Clinic, San José del Cabo, Mexico","result":"No results posted; status unknown since April 2022 (ClinicalTrials.gov NCT02366884).","started":"2011-07-26","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07562152","kind":"trial","name":"Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma","aka":["MAPKeeper 301"],"tldr":"A phase 3 trial testing Atebimetinib in pancreatic ductal adenocarcinoma, now recruiting.","summary":"Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma is a phase 3 interventional study registered as NCT07562152, led by Immuneering, and recruiting on the registry. Official title: A Phase 3 Randomised, Open-Label Study of Atebimetinib in Combination With the Modified Gemcitabine and Nab-Paclitaxel Regimen Versus the Standard Gemcitabine and Nab-Paclitaxel Regimen for the Treatment of Patients With Metastatic Pancreatic Ductal Pancreatic Adenocarcinoma Cancer (MAPKeeper 301). Planned enrolment is 510 participants (estimated). The study started in 2026-06-05 and primary completion is expected in 2028-06. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07562152","url":"https://clinicaltrials.gov/study/NCT07562152"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["atebimetinib"],"companies":["immuneering"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07562152","phase":"3","setting":"A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination With the Modified Gemcitabine and Nab-Paclitaxel Regimen Versus the Standard Gemcitabine and Nab-Paclitaxel Regimen for the Treatment of Patients With Metastatic Pancreatic Ductal Pancreatic Adenocarcinoma Cancer (MAPKeeper 301)","sponsor":"Immuneering","started":"2026-06-05","startedType":"actual","enrolled":510,"enrolledBasis":"registry","outcomes":[]},{"id":"atempt","kind":"trial","name":"ATEMPT","aka":[],"tldr":"ATEMPT tested whether a year of the antibody-drug conjugate T-DM1 could replace chemotherapy plus trastuzumab for the smallest HER2-positive breast cancers; almost no one relapsed on T-DM1, but it was not less toxic overall, so it is an alternative rather than a replacement.","summary":"The APT trial had shown that paclitaxel plus trastuzumab cures almost all node-negative HER2-positive tumours of 3 cm or less. ATEMPT randomised 497 patients with stage I HER2-positive breast cancer three to one to 17 cycles of trastuzumab emtansine or to the APT regimen. The co-primary endpoints were invasive disease-free survival with T-DM1 and a comparison of clinically relevant toxicities.\n\nThree-year invasive disease-free survival with T-DM1 was very high, but the rate of clinically relevant toxicity was similar in the two arms, so the toxicity endpoint was not met; T-DM1 caused more thrombocytopenia and liver enzyme rises, paclitaxel more neuropathy and alopecia. T-DM1 is now listed as an alternative adjuvant option for stage I disease, especially for patients who wish to avoid chemotherapy side effects.","status":"mixed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01853748","url":"https://clinicaltrials.gov/study/NCT01853748"}],"tags":["subtype-trials"],"related":[],"cancers":["her2-positive-early-breast-cancer","breast-her2-positive","breast-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-emtansine","paclitaxel","trastuzumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sara-tolaney"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01853748","phase":"2","setting":"Stage I HER2-positive breast cancer: one year of trastuzumab emtansine against paclitaxel plus trastuzumab (the APT regimen)","sponsor":"Dana-Farber Cancer Institute","result":"Very high three-year invasive disease-free survival with one year of trastuzumab emtansine in stage I disease, but clinically relevant toxicity was not lower than with paclitaxel plus trastuzumab.","started":"2013-05","yearReported":2021,"enrolled":512,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 3 years (registry results)","primary":true,"unit":"%","arms":[{"name":"Trastuzumab emtansine","value":97.8,"note":"95% CI 96.3 to 99.3"},{"name":"Paclitaxel + trastuzumab","value":93.4,"note":"95% CI 88.9 to 98.8"}],"source":"https://clinicaltrials.gov/study/NCT01853748?tab=results"}]},{"id":"nct04434040","kind":"trial","name":"Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)","aka":["ASPRIA"],"tldr":"A phase 2 trial of atezolizumab and sacituzumab govitecan in triple-negative breast cancer, run by Dana-Farber Cancer Institute, now recruiting.","summary":"Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA) is a phase 2, interventional study registered as NCT04434040 by Dana-Farber Cancer Institute, with a registry enrolment figure of 40 participants, started 2020-07-02 and due to reach its primary completion in 2026-12-30. Interventions recorded: Atezolizumab; Sacituzumab govitecan. Conditions listed: Breast Cancer; Triple Negative Breast Cancer; Residual Cancer; Circulating Tumor DNA. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04434040","url":"https://clinicaltrials.gov/study/NCT04434040"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab","sacituzumab-govitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04434040","phase":"2","setting":"A Single Arm Phase 2 Trial of Atezolizumab With Sacituzumab Govitecan to Prevent Recurrence in Triple Negative Breast Cancer (ASPRIA)","sponsor":"Dana-Farber Cancer Institute","started":"2020-07-02","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06690840","kind":"trial","name":"Atezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients","aka":["AZALEA"],"tldr":"A phase 2 trial of atezolizumab, cyclophosphamide and vinorelbine in triple-negative breast cancer, run by European Institute of Oncology, now recruiting.","summary":"Atezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients is a phase 2, interventional study registered as NCT06690840 by European Institute of Oncology, with a registry enrolment figure of 45 participants, started 2025-03-06 and due to reach its primary completion in 2026-12-15. Interventions recorded: Atezolizumab in combination with Cyclophosphamide and Vinorelbine. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Patients with locally advanced or metastatic, histologically documented TNBC (absence of human epidermal growth factor 2 \\[HER2\\], estrogen receptor \\[ER\\], and progesterone receptor \\[PR\\] expression) PD-L1+ (Immune Cell \\>1% using Ventana SP142 assay), not amenable to surgical therapy\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06690840","url":"https://clinicaltrials.gov/study/NCT06690840"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["atezolizumab","cyclophosphamide","vinorelbine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06690840","phase":"2","setting":"A Phase II Study of Atezolizumab, Vinorelbine and Weekly Cyclophosphamide as T-cell Activators in First Line Metastatic Triple Negative Breast Cancer Patients Pre-treated With Anti-PD-L1/PD-1","sponsor":"European Institute of Oncology","started":"2025-03-06","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06663098","kind":"trial","name":"Atezolizumab and Rechallenge Chemotherapy in Relapsed Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC).","aka":["CARRY-ON"],"tldr":"A phase 2 trial of atezolizumab, carboplatin and etoposide in lung cancer, run by Gruppo Oncologico Italiano di Ricerca Clinica, now recruiting.","summary":"Atezolizumab and Rechallenge Chemotherapy in Relapsed Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC). is a phase 2, interventional study registered as NCT06663098 by Gruppo Oncologico Italiano di Ricerca Clinica, with a registry enrolment figure of 142 participants, started 2025-01-24 and due to reach its primary completion in 2028-08-30. Interventions recorded: Atezolizumab; Carboplatin; Etoposide. Conditions listed: Extensive Stage Small Cell Lung Cancer (ES-SCLC). Primary outcome: overall survival. Lung eligibility wording from the registry: \"Diagnosis of small-cell lung cancer (SCLC) (according to WHO classification 2015) confirmed at pathology (histology or cytology)\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06663098","url":"https://clinicaltrials.gov/study/NCT06663098"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["atezolizumab","carboplatin","etoposide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06663098","phase":"2","setting":"Continued PD-L1 Inhibition With Atezolizumab With Rechallenge Chemotherapy in Patients With Sensitive Relapse SCLC Progressing on First-line Platinum-etoposide Chemotherapy and a PD-L1 Inhibitor: CARRY-ON Study-GOIRC-01-2023","sponsor":"Gruppo Oncologico Italiano di Ricerca Clinica","started":"2025-01-24","startedType":"actual","enrolled":142,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03977194","kind":"trial","name":"Atezolizumab in Elderly Patients With Advanced Non-Small-Cell Lung Cancer and Receiving Carboplatin Paclitaxel Chemotherapy","aka":["ELDERLY"],"tldr":"A phase 3 trial of carboplatin, paclitaxel / nab-paclitaxel and atezolizumab in lung cancer, run by Intergroupe Francophone de Cancerologie Thoracique, active but no longer recruiting.","summary":"Atezolizumab in Elderly Patients With Advanced Non-Small-Cell Lung Cancer and Receiving Carboplatin Paclitaxel Chemotherapy is a phase 3, randomised interventional study registered as NCT03977194 by Intergroupe Francophone de Cancerologie Thoracique, with a registry enrolment figure of 510 participants, started 2019-07-23 and due to reach its primary completion in 2024-08-31. Interventions recorded: Carboplatin; Paclitaxel; Atezolizumab. Conditions listed: Non Small Cell Lung Cancer Metastatic. Primary outcome: Overall Survival. Lung eligibility wording from the registry: \"Histologically confirmed NSCLC\". Sites: France. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03977194","url":"https://clinicaltrials.gov/study/NCT03977194"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","paclitaxel","atezolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03977194","phase":"3","setting":"Phase III Randomized Trial of Atezolizumab in Elderly Patients With Advanced Non-Small-Cell Lung Cancer and Receiving Monthly Carboplatin With Weekly Paclitaxel Chemotherapy","sponsor":"Intergroupe Francophone de Cancerologie Thoracique","started":"2019-07-23","startedType":"actual","enrolled":510,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05000294","kind":"trial","name":"Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types","aka":[],"tldr":"A phase 1/2 trial of atezolizumab and tivozanib in gallbladder cancer, run by University of Florida, now recruiting.","summary":"Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types is a phase 1/2 interventional study registered as NCT05000294 by University of Florida, with a registry enrolment figure of 29 participants, started 2021-12-07 and due to reach its primary completion in 2026-12. Interventions recorded: Atezolizumab, Tivozanib. Conditions listed: Bile Duct Cancer, Gall Bladder Cancer, Breast Cancer, Neuroendocrine Tumors, Ovarian Cancer, Pancreatic Adenocarcinoma, Soft Tissue Sarcoma, Vulvar Cancer, Prostate Cancer. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05000294","url":"https://clinicaltrials.gov/study/NCT05000294"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["atezolizumab","tivozanib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05000294","phase":"1/2","setting":"Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types","sponsor":"University of Florida","started":"2021-12-07","startedType":"actual","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"athena-mono","kind":"trial","name":"ATHENA-MONO / GOG-3020","aka":[],"tldr":"A third PARP inhibitor showed the same pattern: longer disease control after first-line chemotherapy, biggest in tumours with faulty DNA repair.","summary":"ATHENA-MONO, also GOG-3020, trial NCT03522246 sponsored by Clovis, now pharma&, and published in JCO in 2022, showed that a third PARP inhibitor follows the same pattern as the others: rucaparib maintenance after response to first-line platinum chemotherapy in newly diagnosed advanced ovarian cancer prolongs disease control, most in tumours with faulty DNA repair. It randomised 538 patients to rucaparib or placebo and met its primary progression-free survival endpoint in the whole population with a larger effect in homologous recombination-deficient disease. OnCo links it to ovarian cancer, PARP as a target, rucaparib and Bradley J. Monk. Clovis went bankrupt in 2022 and US first-line maintenance labelling did not follow, so whether rucaparib ever takes a place beside olaparib and niraparib in first-line maintenance is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03522246","url":"https://clinicaltrials.gov/study/NCT03522246"},{"label":"JCO 2022","url":"https://ascopubs.org/doi/abs/10.1200/JCO.22.01003"}],"tags":[],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":["parp"],"drugs":["rucaparib"],"companies":["clovis-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["bradley-monk"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03522246","phase":"3","setting":"Newly diagnosed advanced ovarian cancer after response to first-line platinum: rucaparib maintenance vs placebo","sponsor":"Clovis (now pharma&)","result":"PFS 20.2 vs 9.2 months (HR 0.52).","started":"2018-05-14","startedType":"actual","yearReported":2022,"enrolled":538,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (ITT)","primary":true,"unit":"months","arms":[{"name":"Rucaparib","n":427,"value":20.2},{"name":"Placebo","n":111,"value":9.2}],"hr":0.52,"ci":[0.4,0.68],"source":"https://ascopubs.org/doi/abs/10.1200/JCO.22.01003"}]},{"id":"atlantis","kind":"trial","name":"ATLANTIS","aka":[],"tldr":"Lurbinectedin's confirmatory trial missed its survival goal, but the drug stayed on the market because the combination tested was not the approved monotherapy dose.","summary":"ATLANTIS, trial NCT02566993 sponsored by PharmaMar and Jazz and reported in 2021, was lurbinectedin's confirmatory trial in relapsed small-cell lung cancer after one platinum line, and it missed its survival goal, though the drug stayed on the market because the combination tested was not the approved monotherapy dose. It randomised 613 patients to lurbinectedin plus doxorubicin or topotecan or CAV chemotherapy, found no difference in overall survival despite better tolerability, and the 2020 accelerated monotherapy approval, based on a basket cohort response rate, was maintained with the FDA later accepting IMforte and the LAGOON trial as confirmatory routes. OnCo links it to small-cell lung cancer, lurbinectedin and topotecan. Head-to-head second-line superiority of lurbinectedin over older chemotherapy remains unproven, which is the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02566993","url":"https://clinicaltrials.gov/study/NCT02566993"}],"tags":["lesson:combination-dose"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["lurbinectedin","topotecan"],"companies":["pharmamar","jazz"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-atlantis-lancet-respir-med-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02566993","phase":"3","setting":"Relapsed SCLC after one platinum line: lurbinectedin + doxorubicin vs topotecan or CAV","sponsor":"PharmaMar / Jazz","result":"OS HR 0.97, not significant.","started":"2016-08-30","startedType":"actual","yearReported":2021,"enrolled":613,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Lurbinectedin + doxorubicin","n":307,"value":8.6},{"name":"Topotecan or CAV","n":306,"value":7.6}],"hr":0.97,"ci":[0.82,1.15],"source":"https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(22)00309-5/abstract"}],"replication":"Monotherapy activity supported by single-arm data and by IMforte in maintenance; head-to-head second-line superiority unproven."},{"id":"atnec","kind":"trial","name":"ATNEC","aka":["Axillary management in breast cancer patients with needle biopsy proven nodal metastases after neoadjuvant chemotherapy"],"tldr":"If chemotherapy has cleared the lymph nodes completely, does the armpit still need an operation or radiotherapy? This British trial is asking, with arm swelling counted as an equal endpoint to survival. It is still recruiting.","summary":"ATNEC opened on 26 February 2021 and is recruiting towards an estimated 1,900 participants, with an estimated primary completion of February 2030. Patients whose nodal disease was proven by needle biopsy at diagnosis and whose sentinel node biopsy after chemotherapy shows no residual cancer are randomised to no further axillary treatment or to axillary treatment, which is either clearance or radiotherapy.\n\nThe design says something about how the field has changed. Disease-free survival and patient-reported lymphoedema are co-primary outcomes, not primary and secondary: the trial is built to fail if the de-escalation is safe but the two arms cannot be separated on arm morbidity, and to succeed on the same footing if it spares arms. Funding is from the National Institute for Health and Care Research under reference NIHR 128311.\n\nATNEC sits alongside NSABP B-51, which asked the radiotherapy half of the same question and found that regional nodal irradiation adds nothing when the nodes clear. No ATNEC results have been published and none are quoted here.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04109079","url":"https://clinicaltrials.gov/study/NCT04109079"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["sentinel-node"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["targeted-axillary-dissection","sentinel-lymph-node-biopsy","axillary-surgery-de-escalation","breast-cancer-related-lymphoedema","neoadjuvant-versus-adjuvant-breast"],"trials":["acosog-z1071","targeted-axillary-dissection-md-anderson","nsabp-b51","posnoc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04109079","phase":"3","setting":"Breast cancer with nodal metastases proven by needle biopsy at diagnosis, and no residual nodal cancer on sentinel node biopsy after chemotherapy: no further axillary treatment against axillary clearance or axillary radiotherapy, with disease-free survival and patient-reported lymphoedema at five years as co-primary outcomes","sponsor":"University Hospitals of Derby and Burton NHS Foundation Trust, funded by the National Institute for Health and Care Research","started":"2021-02-26","startedType":"actual","enrolled":1900,"enrolledBasis":"registry","outcomes":[]},{"id":"atomic","kind":"trial","name":"ATOMIC (Alliance A021502)","aka":[],"tldr":"Adding a year of immunotherapy to chemotherapy after surgery halved recurrences in stage III colon cancers with a broken DNA spell-checker.","summary":"ASCO 2025 plenary: 3-year DFS 86.4% vs 76.6% (HR 0.50). The first phase 3 to show immunotherapy benefit in the adjuvant colon setting; establishes a new standard for the ~10-15% of stage III colon cancers that are dMMR. Whether chemotherapy is needed at all in this group (NICHE-2 logic) is the next question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02912559","url":"https://clinicaltrials.gov/study/NCT02912559"},{"label":"ASCO 2025 LBA1","url":"https://ascopubs.org/doi/10.1200/JCO.2025.43.17_suppl.LBA1"}],"tags":[],"related":[],"cancers":["colorectal","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab","folfox"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":["msi","neoadjuvant-adjuvant"],"trials":["n0147","petacc-8","idea-collaboration","nct05855200"],"people":[],"bottlenecks":[],"keyPapers":["paper-atomic-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02912559","phase":"3","setting":"Resected stage III dMMR colon cancer: adjuvant FOLFOX + atezolizumab (12 months) vs FOLFOX","sponsor":"Alliance / NCI","result":"3-year DFS 86.4% vs 76.6%, HR 0.50.","started":"2017-10-16","startedType":"actual","yearReported":2025,"enrolled":712,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 3 years","primary":true,"unit":"percent","arms":[{"name":"FOLFOX + atezolizumab","n":355,"value":86.4},{"name":"FOLFOX","n":357,"value":76.6}],"hr":0.5,"ci":[0.34,0.72],"source":"https://ascopubs.org/doi/10.1200/JCO.2025.43.17_suppl.LBA1"}],"replication":"First and only randomised adjuvant IO trial in dMMR colon cancer; consistent in direction with NICHE-2 and the metastatic trials."},{"id":"attraction-2","kind":"trial","name":"ATTRACTION-2","aka":[],"tldr":"ATTRACTION-2 was the first randomised trial to show that an immunotherapy drug, nivolumab, helps people with heavily pretreated stomach cancer live longer than placebo, and it made nivolumab a late-line option in East Asia before any Western approval.","summary":"ATTRACTION-2 was a double-blind phase 3 trial run by Ono Pharmaceutical across Japan, South Korea and Taiwan in patients with unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer that had progressed after two or more chemotherapy regimens. Patients were randomised two to one to nivolumab or placebo; PD-L1 expression was not required and was analysed afterwards.\n\nNivolumab prolonged overall survival compared with placebo, the primary endpoint, and the benefit held in longer follow-up. The result led to approval of nivolumab for previously treated gastric cancer in Japan in September 2017, the first checkpoint inhibitor approval in this disease, and it seeded the first-line chemo-immunotherapy trials that followed (ATTRACTION-4 and CheckMate 649).","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02267343","url":"https://clinicaltrials.gov/study/NCT02267343"}],"tags":["subtype-trials"],"related":[],"cancers":["gastric-pdl1-high","gastric"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["kang-yoon-koo"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02267343","phase":"3","setting":"Advanced gastric or gastro-oesophageal junction cancer in Japan, South Korea and Taiwan after at least two prior chemotherapy regimens: nivolumab or placebo, irrespective of PD-L1 expression","sponsor":"Ono Pharmaceutical","result":"Nivolumab improved overall survival over placebo in heavily pretreated advanced gastric cancer; approved in Japan in September 2017.","started":"2014-10","startedType":"actual","yearReported":2017,"enrolled":493,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab 3 mg/kg","n":330,"value":5.26},{"name":"Placebo","n":163,"value":4.14}],"hr":0.63,"ci":[0.51,0.78],"p":"<0.0001","source":"https://doi.org/10.1016/s0140-6736(17)31827-5"},{"endpoint":"Overall survival at 12 months","unit":"%","arms":[{"name":"Nivolumab 3 mg/kg","n":330,"value":26.2},{"name":"Placebo","n":163,"value":10.9}],"source":"https://doi.org/10.1016/s0140-6736(17)31827-5"},{"endpoint":"Grade 3-4 treatment-related adverse events","unit":"%","arms":[{"name":"Nivolumab 3 mg/kg","n":330,"value":10},{"name":"Placebo","n":161,"value":4}],"source":"https://doi.org/10.1016/s0140-6736(17)31827-5"}]},{"id":"nct04807257","kind":"trial","name":"Auger Molecular Therapy (AMT) for Malignant Cutaneous Lesions Treatment","aka":[],"tldr":"A phase 1/2 trial of Auger Molecular Therapy (AMT) in advanced solid tumours, run by NanoRay Biotech Co., Ltd., now recruiting.","summary":"Auger Molecular Therapy (AMT) for Malignant Cutaneous Lesions Treatment is a phase 1/2 interventional study registered as NCT04807257 by NanoRay Biotech Co., Ltd., with 18 participants planned, started 2024-08-05 and due to reach its primary completion in 2025-12-31. Interventions recorded: Auger Molecular Therapy (AMT).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04807257","url":"https://clinicaltrials.gov/study/NCT04807257"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04807257","phase":"1/2","setting":"A First-in-Human Study of Auger Molecular Therapy (AMT) in Patients With Malignant Cutaneous Lesions From Advanced Solid Tumors","sponsor":"NanoRay Biotech Co., Ltd.","started":"2024-08-05","startedType":"estimated","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"augment","kind":"trial","name":"AUGMENT","aka":[],"tldr":"AUGMENT showed that pairing rituximab with the immune-modulating tablet lenalidomide kept relapsed follicular lymphoma under control for much longer than rituximab alone, giving patients a chemotherapy-free option.","summary":"AUGMENT randomised 358 patients with relapsed or refractory follicular lymphoma (grades 1 to 3a) or marginal zone lymphoma who were not rituximab-refractory to rituximab plus lenalidomide for 12 cycles or rituximab plus placebo. The primary endpoint was progression-free survival by independent review.\n\nThe lenalidomide combination roughly tripled median progression-free survival compared with rituximab alone and improved response rates, at the cost of more neutropenia and skin reactions. It was approved in the United States in May 2019 for previously treated follicular and marginal zone lymphoma and became the reference chemotherapy-free regimen against which bispecific antibodies are now being tested.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01938001","url":"https://clinicaltrials.gov/study/NCT01938001"}],"tags":["subtype-trials"],"related":[],"cancers":["follicular-lymphoma","marginal-zone-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["protac-degrader"],"targets":[],"drugs":["lenalidomide","rituximab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["john-leonard"],"bottlenecks":[],"keyPapers":["paper-augment-lenalidomide-rituximab-leonard-jco-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01938001","phase":"3","setting":"Relapsed or refractory follicular or marginal zone lymphoma: lenalidomide plus rituximab against rituximab plus placebo","sponsor":"Celgene (Bristol Myers Squibb)","result":"Lenalidomide plus rituximab substantially lengthened progression-free survival compared with rituximab alone; approved in May 2019.","started":"2013-11-21","startedType":"actual","yearReported":2019,"enrolled":358,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (independent radiology review)","primary":true,"unit":"months","arms":[{"name":"Lenalidomide + rituximab","n":178,"value":39.4},{"name":"Placebo + rituximab","n":180,"value":14.1}],"hr":0.46,"ci":[0.34,0.62],"p":"<0.001","source":"https://doi.org/10.1200/JCO.19.00010"},{"endpoint":"Grade 3-4 neutropenia","unit":"%","arms":[{"name":"Lenalidomide + rituximab","value":50},{"name":"Placebo + rituximab","value":13}],"source":"https://doi.org/10.1200/JCO.19.00010"}]},{"id":"augment-101","kind":"trial","name":"AUGMENT-101","aka":[],"tldr":"The trial that turned menin inhibition from an idea into the first approved drug for KMT2A-rearranged leukaemia.","summary":"KMT2Ar cohort (n=57 efficacy population): CR+CRh 22.8%, ORR 63.2%, most CR/CRh MRD-negative; median OS ~8 months. JCO 2024. Led to November 2024 approval in KMT2Ar acute leukaemia (adults and children ≥1 year) and, with the NPM1 cohort, to the October 2025 NPM1 approval. Differentiation syndrome and QT prolongation were the key toxicities; MEN1 resistance mutations emerged in about a third of relapsing patients.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04065399","url":"https://clinicaltrials.gov/study/NCT04065399"}],"tags":[],"related":[],"cancers":["aml","all-leukemia","aml-npm1-kmt2a"],"sections":[],"technologies":["epigenetic-drugs"],"targets":["menin","kmt2a","npm1"],"drugs":["revumenib"],"companies":["syndax"],"institutions":[],"pathways":[],"terms":["differentiation-syndrome"],"trials":[],"people":["eytan-stein","ghayas-issa"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04065399","phase":"1/2","setting":"Relapsed/refractory KMT2A-rearranged or NPM1-mutated acute leukaemia: revumenib monotherapy","sponsor":"Syndax","result":"CR+CRh 22.8%, ORR 63.2% in KMT2Ar cohort.","started":"2019-11-05","startedType":"actual","yearReported":2024,"enrolled":94,"enrolledBasis":"treated","enrolledNote":"ClinicalTrials.gov lists an estimated 447 participants for the whole phase 1/2 programme, which is still recruiting; the JCO 2024 KMT2A-rearranged analysis treated 94 patients between October 2021 and July 2023 (57 efficacy-evaluable).","outcomes":[{"endpoint":"CR + CRh (KMT2Ar cohort)","primary":true,"unit":"%","arms":[{"name":"Revumenib","n":57,"value":22.8}],"source":"https://ascopubs.org/doi/10.1200/JCO.24.00826"},{"endpoint":"Overall response rate","unit":"%","arms":[{"name":"Revumenib","value":63.2}],"source":"https://doi.org/10.1200/JCO.24.00826"}],"replication":"KOMET-001 (ziftomenib, a different menin inhibitor) produced a similar CR rate in NPM1-mutated AML, confirming the target."},{"id":"nct04923906","kind":"trial","name":"Aumolertinib with or Without Chemotherapy As 1st Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing EGFR Mut","aka":[],"tldr":"A phase 3 trial of Aumolertinib in non-small-cell lung cancer and small-cell lung cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"Aumolertinib with or Without Chemotherapy As 1st Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing EGFR Mutations is a phase 3 interventional study registered as NCT04923906 by Jiangsu Hansoh Pharmaceutical Co., Ltd., with 624 participants planned, started 2021-08-11 and due to reach its primary completion in 2024-06-18. Interventions recorded: Aumolertinib, Placebo Aumolertinib. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04923906","url":"https://clinicaltrials.gov/study/NCT04923906"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["aumolertinib"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04923906-lancet-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04923906","phase":"3","setting":"Efficacy and Safety of Aumolertinib with or Without Chemotherapy As First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing Epidermal Growth Factor Receptor Mutations: a Randomized, Controlled, Open-label, Phase 3 and Multicenter Clinical Study","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","started":"2021-08-11","startedType":"actual","enrolled":624,"enrolledBasis":"registry","outcomes":[]},{"id":"aura3","kind":"trial","name":"AURA3","aka":[],"tldr":"Proved that a drug designed against the specific mutation that causes resistance works far better than chemotherapy, and made resistance testing part of routine lung cancer care.","summary":"When a lung cancer driven by an EGFR mutation stops responding to a first- or second-generation inhibitor, about half the time the reason is a second mutation, T790M, in the gatekeeper position of the kinase. Osimertinib was designed to bind that residue covalently while sparing wild-type EGFR. AURA3 randomised 419 patients whose disease had progressed on first-line EGFR inhibition and whose tumour carried T790M 2:1 to osimertinib 80 mg daily or to pemetrexed with carboplatin or cisplatin every three weeks for up to six cycles, with maintenance pemetrexed allowed.\n\nMedian progression-free survival was 10.1 months with osimertinib against 4.4 months with chemotherapy (hazard ratio 0.30, 95 percent confidence interval 0.23 to 0.41), including in patients with central nervous system metastases.\n\nAURA3 confirmed the accelerated approval osimertinib had received in 2015 and established the practice of re-biopsying, or testing plasma for, the resistance mutation at progression. FLAURA then moved osimertinib to first line, which removed most of the T790M population: the mutation arises under pressure from the older drugs, and when they are not used, it is not selected for.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02151981","url":"https://clinicaltrials.gov/study/NCT02151981"},{"label":"AURA3 (New England Journal of Medicine 2017)","url":"https://doi.org/10.1056/NEJMoa1612674"},{"label":"NICE TA653: osimertinib for EGFR T790M mutation-positive advanced non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta653"}],"tags":[],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors","cytotoxic-chemotherapy","platinum","liquid-biopsy"],"targets":["egfr"],"drugs":["osimertinib","pemetrexed","carboplatin","cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["gatekeeper-mutation","resistance","tki-term","brain-metastases"],"trials":["flaura"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02151981","phase":"3","setting":"EGFR T790M-positive advanced non-small-cell lung cancer progressing after a first-line EGFR inhibitor: osimertinib 80 mg daily versus pemetrexed with carboplatin or cisplatin, with investigator-assessed progression-free survival as the primary endpoint","sponsor":"AstraZeneca","result":"Median progression-free survival 10.1 against 4.4 months (hazard ratio 0.30, 95 percent confidence interval 0.23 to 0.41).","started":"2014-08-04","startedType":"actual","yearReported":2017,"enrolled":419,"enrolledBasis":"randomised","enrolledNote":"419 patients were randomised in the primary publication; the ClinicalTrials.gov record for NCT02151981 gives 421.","outcomes":[{"endpoint":"Progression-free survival (investigator assessed)","primary":true,"unit":"months","arms":[{"name":"Osimertinib","value":10.1},{"name":"Platinum and pemetrexed","value":4.4}],"hr":0.3,"ci":[0.23,0.41],"source":"https://doi.org/10.1056/NEJMoa1612674"}],"replication":"Consistent with the single-arm AURA extension and AURA2 cohorts on which the accelerated approval rested."},{"id":"aurelia","kind":"trial","name":"AURELIA","aka":["MO22224"],"tldr":"AURELIA showed that adding bevacizumab to single-drug chemotherapy for ovarian cancer that has stopped responding to platinum doubled the time before the cancer grew again, from 3.4 to 6.7 months, and more than doubled the response rate, though it did not clearly lengthen life.","summary":"AURELIA was an open-label phase 3 trial in 361 women with platinum-resistant ovarian cancer randomised to the investigator's choice of weekly paclitaxel, pegylated liposomal doxorubicin or topotecan, alone or with bevacizumab. The primary endpoint was progression-free survival.\n\nMedian progression-free survival was 6.7 months with bevacizumab against 3.4 months with chemotherapy alone (hazard ratio 0.48), the response rate 27.3 against 11.8 percent and median overall survival 16.6 against 13.3 months (hazard ratio 0.85, not significant). Hypertension and proteinuria were more common with bevacizumab and gastrointestinal perforation occurred in 2.2 percent. The trial led to approval of bevacizumab with chemotherapy for platinum-resistant disease in the United States in November 2014, which is how the corpus's platinum-resistant ovarian cancer page cites it.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00976911","url":"https://clinicaltrials.gov/study/NCT00976911"}],"tags":["soc-trials"],"related":[],"cancers":["platinum-resistant-ovarian-cancer","ovarian"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["bevacizumab","paclitaxel","pegylated-liposomal-doxorubicin","topotecan"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-aurelia-bevacizumab-platinum-resistant-ovarian-pujade-lauraine-jco-2014"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00976911","phase":"3","setting":"Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer after no more than two prior regimens: the investigator's single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin or topotecan) with or without bevacizumab, with progression-free survival as the primary endpoint","sponsor":"Hoffmann-La Roche","result":"Median progression-free survival 6.7 months with bevacizumab plus chemotherapy against 3.4 months with chemotherapy alone (hazard ratio 0.48, p < 0.001); response rate 27.3 against 11.8 percent; overall survival not significantly different (16.6 against 13.3 months).","started":"2009-10-29","startedType":"actual","yearReported":2014,"enrolled":361,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Bevacizumab + single-agent chemotherapy","value":6.7},{"name":"Single-agent chemotherapy","value":3.4}],"hr":0.48,"ci":[0.38,0.6],"p":"<0.001","source":"https://doi.org/10.1200/JCO.2013.51.4489"},{"endpoint":"Progression-free survival (registry results, November 2011 cut-off)","unit":"months","arms":[{"name":"Bevacizumab + single-agent chemotherapy","value":6.8,"note":"95% CI 5.62 to 7.79"},{"name":"Single-agent chemotherapy","value":3.4,"note":"95% CI 2.10 to 3.75"}],"hr":0.46,"ci":[0.366,0.577],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT00976911?tab=results"},{"endpoint":"Objective response rate (RECIST)","unit":"%","arms":[{"name":"Bevacizumab + single-agent chemotherapy","value":27.3},{"name":"Single-agent chemotherapy","value":11.8}],"p":"0.001","source":"https://doi.org/10.1200/JCO.2013.51.4489"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Bevacizumab + single-agent chemotherapy","value":16.6},{"name":"Single-agent chemotherapy","value":13.3}],"hr":0.85,"ci":[0.66,1.08],"p":"0.174","source":"https://doi.org/10.1200/JCO.2013.51.4489"},{"endpoint":"Gastrointestinal perforation","unit":"%","arms":[{"name":"Bevacizumab + single-agent chemotherapy","value":2.2}],"source":"https://doi.org/10.1200/JCO.2013.51.4489"}]},{"id":"nct07537660","kind":"trial","name":"Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Gemcitabine Plus Paclitaxel","aka":["ADGP"],"tldr":"A phase 2 trial of dexamethasone in pancreatic cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Gemcitabine Plus Paclitaxel is a phase 2, interventional study registered as NCT07537660 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 25 participants, started 2025-11-25 and due to reach its primary completion in 2026-11. Interventions recorded: Auricular point stimulation plus dexamethasone. Conditions listed: Nausea and Vomiting Caused by Chemotherapy. Primary outcome: Proportion of patients experiencing nausea as assessed by NIC-CTC AE4.0. Pancreatic eligibility wording from the registry: \"* Patients with pancreatic cancer after radical resection or with advanced pancreatic cancer, who require further chemotherapy with the gemcitabine plus paclitaxel albumin-bound regimen;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07537660","url":"https://clinicaltrials.gov/study/NCT07537660"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["dexamethasone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07537660","phase":"2","setting":"Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Gemcitabine Combined With Paclitaxel Protein-bound in Pancreatic Cancer Treatment","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2025-11-25","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07716228","kind":"trial","name":"Auricular Point Stimulation Plus Dexamethasone Versus Standard Antiemetic Regimen for Nausea and Vomiting Caused by Gemcitabine Combined With Paclitaxel Protein","aka":["ADGP II"],"tldr":"A phase 3 trial of dexamethasone in pancreatic cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"Auricular Point Stimulation Plus Dexamethasone Versus Standard Antiemetic Regimen for Nausea and Vomiting Caused by Gemcitabine Combined With Paclitaxel Protein-bound is a phase 3, randomised interventional study registered as NCT07716228 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 74 participants, started 2025-12-12 and due to reach its primary completion in 2026-12-06. Interventions recorded: Auricular point stimulation plus dexamethasone; Standard pharmacologic antiemetic regimen. Conditions listed: Nausea and Vomiting Caused by Chemotherapy. Primary outcome: Proportion of patients experiencing nausea as assessed by NIC-CTC AE4.0. Pancreatic eligibility wording from the registry: \"* Patients must meet the following inclusion criteria for the study: \\* Age ≥ 18 years and ≤ 85 years; \\* Patients with pancreatic cancer after radical resection or with advanced pancreatic cancer, who require further chemotherapy with the gemcitabine plus paclitaxel albumin-bound regimen; \\* ECOG p\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07716228","url":"https://clinicaltrials.gov/study/NCT07716228"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["dexamethasone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07716228","phase":"3","setting":"Auricular Point Stimulation Plus Dexamethasone Versus Standard Antiemetic Regimen for Nausea and Vomiting Caused by Gemcitabine Combined With Paclitaxel Protein-bound in Pancreatic Cancer Treatment","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2025-12-12","startedType":"actual","enrolled":74,"enrolledBasis":"registry","outcomes":[]},{"id":"autogene-cevumeran-phase-1","kind":"trial","name":"Autogene cevumeran phase 1 in resected pancreatic cancer (Memorial Sloan Kettering)","aka":["Rojas 2023","BNT122 pancreatic phase 1","RO7198457 pancreatic phase 1"],"tldr":"This is the small New York trial behind the excitement about personalised mRNA cancer vaccines: half of the 16 patients vaccinated after pancreatic surgery made strong T cells against their own tumour mutations, and those responders had far fewer relapses after more than three years, with vaccine-induced T cells predicted to last for years.","summary":"Sixteen patients were treated with atezolizumab and autogene cevumeran and 15 went on to modified FOLFIRINOX; vaccines were manufactured in real time from the resected tumours and given within three days of benchmarked times. Eight of 16 mounted high-magnitude neoantigen-specific T cells (up to 10 percent of blood T cells), half against more than one neoantigen. At 18 months median recurrence-free survival was not reached in responders against 13.4 months in non-responders (p 0.003; Nature 2023), and at a 3.2-year median follow-up the difference held (median not reached against 13.4 months; p 0.007), with vaccine-induced CD8 T cell clones estimated to live 7.7 years on average, 86 percent of clones per patient persisting at about three years, and recurrent tumours pruned of the vaccine-targeted clones (Nature 2025). Responders and non-responders had mounted equivalent immunity to a concurrent SARS-CoV-2 vaccine, arguing against a fitness confounder. The registry (NCT04161755) lists 29 participants, active but no longer recruiting, primary completion November 2026. The randomised phase 2 IMCODE003 (260 patients, adjuvant autogene cevumeran with atezolizumab and modified FOLFIRINOX against chemotherapy alone, eight UK sites) will test whether this translates into fewer relapses.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04161755","url":"https://clinicaltrials.gov/study/NCT04161755"},{"label":"Rojas et al., personalised RNA neoantigen vaccines stimulate T cells in pancreatic cancer (Nature 2023)","url":"https://doi.org/10.1038/s41586-023-06063-y"},{"label":"Sethna et al., RNA neoantigen vaccines prime long-lived CD8 T cells in pancreatic cancer (Nature 2025)","url":"https://doi.org/10.1038/s41586-024-08508-4"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["neoantigen-mrna-vaccine","checkpoint-inhibitor"],"targets":[],"drugs":["autogene-cevumeran","atezolizumab","folfirinox"],"companies":["biontech","roche-genentech"],"institutions":["mskcc"],"pathways":[],"terms":["cold-vs-hot","mrd"],"trials":["nct05968326"],"people":["vinod-balachandran"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04161755","phase":"1","setting":"Surgically resected pancreatic ductal adenocarcinoma: atezolizumab, then a personalised mRNA neoantigen vaccine made from each patient's tumour (up to 20 neoantigens), then modified FOLFIRINOX, a single-arm phase 1 with toxicity as the primary endpoint","sponsor":"Memorial Sloan Kettering Cancer Center, with Genentech and BioNTech","result":"Vaccine-induced T cells in 8 of 16 patients; median recurrence-free survival not reached in responders against 13.4 months in non-responders (p 0.003 at 18 months; p 0.007 at 3.2 years).","started":"2019-12-13","startedType":"actual","yearReported":2023,"enrolled":29,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free survival by vaccine response (exploratory)","unit":"months","arms":[{"name":"Vaccine responders","n":8,"note":"Median not reached at 3.2 years"},{"name":"Non-responders","n":8,"value":13.4}],"p":"0.007","source":"https://doi.org/10.1038/s41586-024-08508-4"}]},{"id":"nct00722228","kind":"trial","name":"Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by Hadassah Medical Organization, now recruiting.","summary":"Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors is a phase 1/2, interventional study registered as NCT00722228 by Hadassah Medical Organization, with a registry enrolment figure of 50 participants, started 2008-07 and due to reach its primary completion in 2025-03. Interventions recorded: Autologous or Allogeneic tumor cells. Conditions listed: Colorectal Cancer; Ovarian Cancer; Gastric Cancer; Breast Cancer; Lung Cancer; Kidney Cancer; Melanoma. Colorectal eligibility wording from the registry: \"* One of the following metastatic cancers: Melanoma, breast, ovary, colorectal, gastric, lung or kidney\". Sites: Israel. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00722228","url":"https://clinicaltrials.gov/study/NCT00722228"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["shared-antigen-vaccine"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00722228","phase":"1/2","setting":"Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors","sponsor":"Hadassah Medical Organization","started":"2008-07","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05261750","kind":"trial","name":"Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer","aka":[],"tldr":"A phase 1/2 trial of Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy) in nasopharyngeal carcinoma, run by PT. Prodia Stem Cell Indonesia, active and no longer recruiting.","summary":"Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer is a phase 1/2 interventional study registered as NCT05261750 by PT. Prodia Stem Cell Indonesia, with 15 participants enrolled, started 2022-04-30 and due to reach its primary completion in 2026-02-28. Interventions recorded: Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy) and Combination of Auto DC and Allo-Dendritic Cell-Secretome (Allogeneic Dendritic Cell-Secretome as Adjuvant Therapy).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05261750","url":"https://clinicaltrials.gov/study/NCT05261750"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nasopharyngeal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05261750","phase":"1/2","setting":"Safety and Efficacy of Adjuvant Therapy of Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer","sponsor":"PT. Prodia Stem Cell Indonesia","started":"2022-04-30","startedType":"actual","enrolled":15,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04614103","kind":"trial","name":"Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of LN-145 in non-small-cell lung cancer, run by Iovance Biotherapeutics, Inc., now recruiting.","summary":"Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer is a phase 2 interventional study registered as NCT04614103 by Iovance Biotherapeutics, Inc., with 170 participants planned, started 2021-05-07 and due to reach its primary completion in 2030-12. Interventions recorded: LN-145.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04614103","url":"https://clinicaltrials.gov/study/NCT04614103"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["iovance"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04614103","phase":"2","setting":"A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (TIL or LN-145) in Patients With Metastatic Non-Small-Cell Lung Cancer","sponsor":"Iovance Biotherapeutics, Inc.","started":"2021-05-07","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06241781","kind":"trial","name":"Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer","aka":[],"tldr":"A phase 2 trial of Gemcitabine in cervical cancer, run by Grit Biotechnology, now recruiting.","summary":"Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer is a phase 2 interventional study registered as NCT06241781 by Grit Biotechnology, with 83 participants planned, started 2024-04-02 and due to reach its primary completion in 2027-01-31. Interventions recorded: GT101 injection and Gemcitabine injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06241781","url":"https://clinicaltrials.gov/study/NCT06241781"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":["grit-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06241781","phase":"2","setting":"A Phase 2, Multicenter Randomized Controlled Open-label Study of Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer","sponsor":"Grit Biotechnology","started":"2024-04-02","startedType":"actual","enrolled":83,"enrolledBasis":"registry","outcomes":[]},{"id":"avaglio","kind":"trial","name":"AVAglio","aka":[],"tldr":"AVAglio tested adding the anti-blood-vessel drug bevacizumab to standard radiotherapy and chemotherapy for newly diagnosed glioblastoma; the tumours took longer to grow on scans, but people did not live any longer, so bevacizumab is not used up front for this cancer.","summary":"AVAglio was a double-blind placebo-controlled phase 3 trial in newly diagnosed glioblastoma. After surgery or biopsy, patients received radiotherapy with concurrent and adjuvant temozolomide and were randomised to bevacizumab or placebo throughout, followed by single-agent maintenance.\n\nBevacizumab prolonged progression-free survival, one of the two primary endpoints, but did not improve overall survival, the other. The parallel US trial RTOG 0825 reached the same conclusion, and together they closed the question of first-line bevacizumab in glioblastoma; the drug remains in use for symptomatic relief and at recurrence, where its 2009 accelerated approval was granted.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00943826","url":"https://clinicaltrials.gov/study/NCT00943826"}],"tags":["subtype-trials"],"related":[],"cancers":["glioblastoma","brain-tumours"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["bevacizumab-glioma","temozolomide"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["olivier-chinot"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00943826","phase":"3","setting":"Newly diagnosed glioblastoma: bevacizumab or placebo added to radiotherapy with temozolomide and continued as maintenance","sponsor":"Roche","result":"Bevacizumab added to radiotherapy and temozolomide prolonged progression-free survival but not overall survival in newly diagnosed glioblastoma.","started":"2009-06-29","startedType":"actual","yearReported":2014,"enrolled":921,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (investigator-assessed)","primary":true,"unit":"months","arms":[{"name":"Bevacizumab + radiotherapy-temozolomide","n":458,"value":10.6},{"name":"Placebo + radiotherapy-temozolomide","n":463,"value":6.2}],"hr":0.64,"ci":[0.55,0.74],"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1308345"},{"endpoint":"Overall survival","primary":true,"arms":[{"name":"Bevacizumab + radiotherapy-temozolomide","n":458,"note":"Medians not reported in the abstract"},{"name":"Placebo + radiotherapy-temozolomide","n":463}],"hr":0.88,"ci":[0.76,1.02],"p":"0.10","source":"https://doi.org/10.1056/nejmoa1308345"},{"endpoint":"Overall survival at 2 years","unit":"%","arms":[{"name":"Bevacizumab + radiotherapy-temozolomide","n":458,"value":33.9},{"name":"Placebo + radiotherapy-temozolomide","n":463,"value":30.1}],"p":"0.24","source":"https://doi.org/10.1056/nejmoa1308345"},{"endpoint":"Grade 3 or higher adverse events","unit":"%","arms":[{"name":"Bevacizumab + radiotherapy-temozolomide","value":66.8},{"name":"Placebo + radiotherapy-temozolomide","value":51.3}],"source":"https://doi.org/10.1056/nejmoa1308345"}]},{"id":"nct04771520","kind":"trial","name":"Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors","aka":[],"tldr":"A phase 2 trial of avapritinib in colorectal cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors is a phase 2, interventional study registered as NCT04771520 by M.D. Anderson Cancer Center, with a registry enrolment figure of 50 participants, started 2021-01-20 and due to reach its primary completion in 2026-12-31. Interventions recorded: Avapritinib. Conditions listed: Anatomic Stage IV Breast Cancer AJCC v8; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Locally Advanced Malignant Solid Neoplasm; Locally Advanced Melanoma; Locally Advanced Primary Malignant Central Nervous System Neoplasm; Locally Advanced Sarcoma; Metastatic Malignant Solid Neoplasm; Metastatic Melanoma; Metastatic Primary Malignant Central Nervous System Neoplasm; Metastatic Sarcoma; Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8. Primary outcome: Overall response rate (ORR). Colorectal eligibility wording from the registry: \"• NOTE: Specific solid tumor types include but are not limited to melanoma, breast cancer, lung cancer, gastroesophageal cancer, colorectal cancer, sarcoma, solid tumors NOS, and primary CNS tumors\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04771520","url":"https://clinicaltrials.gov/study/NCT04771520"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["avapritinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04771520","phase":"2","setting":"Phase 2 Study of Avapritinib in Patients With CKIT or PDGFRA Mutation-Positive Malignant Solid Tumors","sponsor":"M.D. Anderson Cancer Center","started":"2021-01-20","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03815643","kind":"trial","name":"Avelumab Program Rollover Study","aka":[],"tldr":"A phase 3 trial of Avelumab in advanced solid tumours, run by EMD Serono Research & Development Institute, Inc., active and no longer recruiting.","summary":"Avelumab Program Rollover Study is a phase 3 interventional study registered as NCT03815643 by EMD Serono Research & Development Institute, Inc., with 205 participants enrolled, started 2019-03-22 and due to reach its primary completion in 2026-08-21. Interventions recorded: Avelumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03815643","url":"https://clinicaltrials.gov/study/NCT03815643"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["avelumab"],"companies":["merck-kgaa"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03815643","phase":"3","setting":"An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies","sponsor":"EMD Serono Research & Development Institute, Inc.","started":"2019-03-22","startedType":"actual","enrolled":205,"enrolledBasis":"registry","outcomes":[]},{"id":"avenger-500","kind":"trial","name":"AVENGER 500","aka":[],"tldr":"Adding the metabolism drug devimistat to FOLFIRINOX did not help people with metastatic pancreatic cancer live longer.","summary":"AVENGER 500 was an open-label phase 3 trial in previously untreated metastatic pancreatic adenocarcinoma comparing modified FOLFIRINOX with devimistat against modified FOLFIRINOX alone. The primary endpoint was overall survival. The trial did not show a survival benefit, and response rates were similar between arms, closing the pancreatic programme for devimistat.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03504423","url":"https://clinicaltrials.gov/study/NCT03504423"},{"label":"Philip et al., Journal of Clinical Oncology 2024: devimistat with modified FOLFIRINOX versus FOLFIRINOX (AVENGER 500)","url":"https://doi.org/10.1200/JCO.23.02659"}],"tags":[],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["devimistat","folfirinox"],"companies":["cornerstone-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-philip-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03504423","phase":"3","setting":"Untreated metastatic pancreatic adenocarcinoma: modified FOLFIRINOX with or without devimistat","sponsor":"Rafael Pharmaceuticals (Cornerstone)","result":"No overall survival benefit from adding devimistat to modified FOLFIRINOX.","started":"2018-11-09","startedType":"actual","yearReported":2024,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Devimistat + modified FOLFIRINOX","n":266,"value":11.1},{"name":"FOLFIRINOX","n":262,"value":11.73}],"hr":0.95,"ci":[0.77,1.18],"p":"0.655","source":"https://doi.org/10.1200/JCO.23.02659"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Devimistat + modified FOLFIRINOX","value":7.8},{"name":"FOLFIRINOX","value":8}],"hr":0.99,"ci":[0.76,1.29],"p":"0.94","source":"https://doi.org/10.1200/JCO.23.02659"}]},{"id":"nct07038343","kind":"trial","name":"AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)","aka":["AVENTINE-1"],"tldr":"A phase 1/2 trial of AVZO-1418 in biliary tract cancer, bladder & urothelial cancer and nasopharyngeal carcinoma, run by Avenzo Therapeutics, Inc., now recruiting.","summary":"AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001) is a phase 1/2 interventional study registered as NCT07038343 by Avenzo Therapeutics, Inc., with 480 participants planned, started 2025-06-04 and due to reach its primary completion in 2030-06. Interventions recorded: AVZO-1418, Combination Agent 1 and Combination Agent 2.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07038343","url":"https://clinicaltrials.gov/study/NCT07038343"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma","urothelial","nasopharyngeal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["avenzo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07038343","phase":"1/2","setting":"A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors","sponsor":"Avenzo Therapeutics, Inc.","started":"2025-06-04","startedType":"actual","enrolled":480,"enrolledBasis":"registry","outcomes":[]},{"id":"avf2107g","kind":"trial","name":"AVF2107g","aka":["Hurwitz bevacizumab trial"],"tldr":"The first trial to show that blocking a tumour's blood supply lengthens life. It added about five months and created a drug class.","summary":"AVF2107g randomised previously untreated metastatic colorectal cancer to IFL chemotherapy with bevacizumab or placebo. Median overall survival was 20.3 against 15.6 months, hazard ratio for death 0.66. It was the first phase 3 trial of an anti-angiogenic antibody to show a survival benefit in any cancer and led to the FDA approval of bevacizumab in February 2004 and the EU marketing authorisation for Avastin on 12 January 2005. The chemotherapy backbone, bolus IFL, is obsolete and the size of the benefit shrank in later trials that used infusional regimens, which is why NICE TA1136 in February 2026 reached bevacizumab only as an option for first- and second-line use when targeted treatment or immunotherapy is unsuitable.","status":"positive","asOf":"2026-09-24","links":[{"label":"AVF2107g: bevacizumab plus irinotecan, fluorouracil and leucovorin for metastatic colorectal cancer (New England Journal of Medicine 2004)","url":"https://doi.org/10.1056/NEJMoa032691"},{"label":"EMA Avastin","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/avastin"},{"label":"NICE TA1136: bevacizumab (originator and biosimilars) with fluoropyrimidine-based chemotherapy for metastatic colorectal cancer","url":"https://www.nice.org.uk/guidance/ta1136"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["monoclonal-antibody","antiangiogenic"],"targets":["vegf"],"drugs":["bevacizumab","irinotecan","fluorouracil","leucovorin"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Previously untreated metastatic colorectal cancer: irinotecan, bolus fluorouracil and leucovorin (IFL) with bevacizumab or with placebo","sponsor":"Genentech","result":"Median overall survival 20.3 against 15.6 months, hazard ratio 0.66.","yearReported":2004,"enrolled":813,"enrolledBasis":"randomised","enrolledNote":"813 patients were randomised; the trial predates ClinicalTrials.gov registration and has no NCT number.","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"IFL plus bevacizumab","value":20.3},{"name":"IFL plus placebo","value":15.6}],"hr":0.66,"source":"https://doi.org/10.1056/NEJMoa032691"}]},{"id":"nct07354919","kind":"trial","name":"Axelopran for Advanced Cancer in Patients Receiving Opioids","aka":["AxeCan"],"tldr":"A phase 2 trial in pancreatic cancer, run by HealthPartners Institute, now recruiting.","summary":"Axelopran for Advanced Cancer in Patients Receiving Opioids is a phase 2, interventional study registered as NCT07354919 by HealthPartners Institute, with a registry enrolment figure of 34 participants, started 2026-04-27 and due to reach its primary completion in 2027-11-01. Interventions recorded: axelopran. Conditions listed: Breast Cancer; Lung Cancer; Pancreas Cancer; Prostate Cancer. Primary outcome: Objective response rate (including complete response and partial response). Pancreatic eligibility wording from the registry: \"Histologically or cytologically proven cancer of the prostate (carcinoma), breast (carcinoma), pancreas (carcinoma), and lung (non-small cell lung carcinoma (NSCLC)) that has relapsed or progressed on or after a standard systemic treatment that has included cytotoxic chemotherapy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07354919","url":"https://clinicaltrials.gov/study/NCT07354919"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07354919","phase":"2","setting":"A Phase II Trial of Cancer Response Using Axelopran in Patients With Advanced Cancers on Opioids (AxeCan)","sponsor":"HealthPartners Institute","started":"2026-04-27","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"aza-001","kind":"trial","name":"AZA-001","aka":[],"tldr":"AZA-001 was the trial that showed a drug could help people with higher-risk myelodysplastic syndromes live longer: azacitidine beat the best conventional care, and it has been the backbone of treatment for this disease ever since.","summary":"AZA-001 was an open-label phase 3 trial in patients with higher-risk myelodysplastic syndromes (intermediate-2 or high risk by the International Prognostic Scoring System). Before randomisation the investigator chose the conventional care regimen the patient would otherwise receive: best supportive care, low-dose cytarabine or standard intensive chemotherapy. Patients were then randomised to subcutaneous azacitidine or to that regimen.\n\nAzacitidine prolonged overall survival compared with conventional care, the primary endpoint, and delayed transformation to acute myeloid leukaemia. It was the first treatment to show a survival benefit in higher-risk MDS and the reason hypomethylating agents became the standard against which venetoclax combinations and newer agents are now tested.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00071799","url":"https://clinicaltrials.gov/study/NCT00071799"}],"tags":["subtype-trials"],"related":[],"cancers":["mds-higher-risk","mds"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["azacitidine"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["pierre-fenaux"],"bottlenecks":[],"keyPapers":["paper-aza-001-fenaux-lancet-oncol-2009"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00071799","phase":"3","setting":"Higher-risk myelodysplastic syndromes: azacitidine against a conventional care regimen (best supportive care, low-dose cytarabine or intensive chemotherapy) chosen for each patient before randomisation","sponsor":"Celgene","result":"Azacitidine improved overall survival over conventional care regimens in higher-risk myelodysplastic syndromes.","started":"2003-11-01","startedType":"actual","yearReported":2009,"enrolled":358,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Azacitidine","n":179,"value":24.5,"note":"Median follow-up 21.1 months"},{"name":"Conventional care regimens","n":179,"value":15}],"hr":0.58,"ci":[0.43,0.77],"p":"0.0001","source":"https://doi.org/10.1016/S1470-2045(09)70003-8"},{"endpoint":"Overall survival at 2 years","unit":"%","arms":[{"name":"Azacitidine","value":50.8},{"name":"Conventional care regimens","value":26.2}],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(09)70003-8"}]},{"id":"nct05850234","kind":"trial","name":"AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)","aka":["DURGA-1"],"tldr":"A phase 1/2 trial of AZD0120 in multiple myeloma, run by AstraZeneca, now recruiting.","summary":"AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1) is a phase 1/2 interventional study registered as NCT05850234 by AstraZeneca, with 232 participants planned, started 2023-07-20 and due to reach its primary completion in 2027-10-01. Interventions recorded: AZD0120.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05850234","url":"https://clinicaltrials.gov/study/NCT05850234"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["azd0120"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05850234","phase":"1/2","setting":"A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)","sponsor":"AstraZeneca","started":"2023-07-20","startedType":"actual","enrolled":232,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06106945","kind":"trial","name":"AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma","aka":[],"tldr":"A phase 1/2 trial of Elranatamab, Pomalidomide, Dexamethasone in multiple myeloma, run by AstraZeneca, now recruiting.","summary":"AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma is a phase 1/2 interventional study registered as NCT06106945 by AstraZeneca, with 226 participants planned, started 2023-12-05 and due to reach its primary completion in 2027-08-16. Interventions recorded: AZD0305, Elranatamab, Pomalidomide, Dexamethasone. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06106945","url":"https://clinicaltrials.gov/study/NCT06106945"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["elranatamab","pomalidomide","dexamethasone"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06106945","phase":"1/2","setting":"A Modular Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Multiple Myeloma","sponsor":"AstraZeneca","started":"2023-12-05","startedType":"actual","enrolled":226,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07215585","kind":"trial","name":"AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL","aka":["SOUNDTRACK-D2"],"tldr":"A phase 3 trial testing AZD0486 in diffuse large B-cell lymphoma, now recruiting.","summary":"AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL is a phase 3 interventional study registered as NCT07215585, led by AstraZeneca, and recruiting on the registry. Official title: A Phase III, Multicentre, Open-Label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x2 Followed by AZD0486 Versus R-mini-CHOP x6 in Elderly or Unfit Participants With Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2). Planned enrolment is 420 participants (estimated). The study started in 2025-11-11 and primary completion is expected in 2030-06-10. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07215585","url":"https://clinicaltrials.gov/study/NCT07215585"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["azd0486"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07215585","phase":"3","setting":"A Phase III, Multicentre, Open-Label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x2 Followed by AZD0486 Versus R-mini-CHOP x6 in Elderly or Unfit Participants With Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2)","sponsor":"AstraZeneca","started":"2025-11-11","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06137118","kind":"trial","name":"AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia","aka":["SYRUS"],"tldr":"A phase 1/2 trial of Surovatamig in acute lymphoblastic leukaemia, run by AstraZeneca, now recruiting.","summary":"AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia is a phase 1/2 interventional study registered as NCT06137118 by AstraZeneca, with 255 participants planned, started 2023-12-29 and due to reach its primary completion in 2028-02-11. Interventions recorded: Surovatamig.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06137118","url":"https://clinicaltrials.gov/study/NCT06137118"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06137118","phase":"1/2","setting":"A Phase 1/2 Study to Evaluate the Safety and Efficacy of AZD0486 in Adolescent and Adult Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia","sponsor":"AstraZeneca","started":"2023-12-29","startedType":"actual","enrolled":255,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06219941","kind":"trial","name":"AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2","aka":["CLARITY-PanTumour01"],"tldr":"A phase 2 trial of Sonesitatug vedotin, FLOT, FOLFIRI in pancreatic ductal adenocarcinoma, run by AstraZeneca, now recruiting.","summary":"AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 is a phase 2 interventional study registered as NCT06219941 by AstraZeneca, with 226 participants planned, started 2023-12-13 and due to reach its primary completion in 2026-11-17. Interventions recorded: AZD0901, 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan. Conditions listed: Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06219941","url":"https://clinicaltrials.gov/study/NCT06219941"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["cmg901","flot","folfiri","irinotecan","gemcitabine"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06219941","phase":"2","setting":"A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01)","sponsor":"AstraZeneca","started":"2023-12-13","startedType":"actual","enrolled":226,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07611110","kind":"trial","name":"AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)","aka":["VECTRA-01"],"tldr":"A phase 3 trial of FPI-2265, Cabazitaxel, Abiraterone acetate in prostate cancer, run by AstraZeneca, now recruiting.","summary":"AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) is a phase 3 interventional study registered as NCT07611110 by AstraZeneca, with 670 participants planned, started 2026-05-04 and due to reach its primary completion in 2029-06-04. Interventions recorded: Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265]), Cabazitaxel, Abiraterone, Enzalutamide, Apalutamide. Conditions listed: Metastatic Castration-resistant Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07611110","url":"https://clinicaltrials.gov/study/NCT07611110"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["fpi-2265","cabazitaxel","abiraterone","enzalutamide","apalutamide","darolutamide"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07611110","phase":"3","setting":"A Phase III, Multicentre, Randomised Controlled Study to Evaluate the Efficacy and Safety of AZD2265 (FPI-2265) ²²⁵Ac-PSMA-I&T Compared With Standard of Care in Patients With PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)","sponsor":"AstraZeneca","started":"2026-05-04","startedType":"actual","enrolled":670,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06137144","kind":"trial","name":"AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies.","aka":["PRIMAVERA"],"tldr":"A phase 1/2 trial of AZD3470, Pembrolizumab in hodgkin lymphoma and non-hodgkin lymphoma, run by AstraZeneca, now recruiting.","summary":"AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies. is a phase 1/2 interventional study registered as NCT06137144 by AstraZeneca, with 161 participants planned, started 2024-01-23 and due to reach its primary completion in 2029-05-03. Interventions recorded: AZD3470, Pembrolizumab. Conditions listed: Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Peripheral T-cell Lymphoma (PTCL). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06137144","url":"https://clinicaltrials.gov/study/NCT06137144"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["azd3470","pembrolizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06137144","phase":"1/2","setting":"A Modular Phase I/II, Open-label, Multicentre Study to Evaluate the Safety, Tolerability, and Efficacy of AZD3470, a PRMT5 Inhibitor, as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies","sponsor":"AstraZeneca","started":"2024-01-23","startedType":"actual","enrolled":161,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07218809","kind":"trial","name":"AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer","aka":["TREVI-OC-01"],"tldr":"A phase 3 trial testing AZD5335 in ovarian cancer, now recruiting.","summary":"AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer is a phase 3 interventional study registered as NCT07218809, led by AstraZeneca with European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation and Ventana Medical Systems, and recruiting on the registry. Official title: A Randomised, Open-label, Phase III Study of AZD5335 Versus Mirvetuximab Soravtansine in FRα-high and AZD5335 Versus Investigator's Choice Chemotherapy in FRα-low Expressing High-grade Platinum-resistant Epithelial Ovarian Cancer Patients (TREVI-OC-01). Planned enrolment is 1100 participants (estimated). The study started in 2025-12-29 and primary completion is expected in 2028-11-17. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07218809","url":"https://clinicaltrials.gov/study/NCT07218809"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["azd5335"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07218809","phase":"3","setting":"A Randomised, Open-label, Phase III Study of AZD5335 Versus Mirvetuximab Soravtansine in FRα-high and AZD5335 Versus Investigator's Choice Chemotherapy in FRα-low Expressing High-grade Platinum-resistant Epithelial Ovarian Cancer Patients (TREVI-OC-01)","sponsor":"AstraZeneca","started":"2025-12-29","startedType":"actual","enrolled":1100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05986851","kind":"trial","name":"Azeliragon in MGMT Unmethylated Glioblastoma","aka":[],"tldr":"A phase 2 trial of Azeliragon in glioma & glioblastoma, run by Cantex Pharmaceuticals, active and no longer recruiting.","summary":"Azeliragon in MGMT Unmethylated Glioblastoma is a phase 2 interventional study registered as NCT05986851 by Cantex Pharmaceuticals, with 30 participants enrolled, started 2023-09-12 and due to reach its primary completion in 2026-09-30. Interventions recorded: Azeliragon.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05986851","url":"https://clinicaltrials.gov/study/NCT05986851"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["medpace"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05986851","phase":"2","setting":"A Phase II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon in Patients With MGMT Unmethylated Glioblastoma","sponsor":"Cantex Pharmaceuticals","started":"2023-09-12","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"azur-1","kind":"trial","name":"AZUR-1","aka":[],"tldr":"AZUR-1 is the registrational trial of the 'no surgery, no radiation, no chemo' approach for mismatch-repair-deficient rectal cancer, built on the MSK study where every patient had a complete response.","summary":"AZUR-1 is a single-arm global trial. It met its primary objective of sustained clinical complete response at 12 months (cCR12); full data due at a 2026 congress. FDA accepted the filing with priority review and a PDUFA date of February 2027, with eligibility for the national priority voucher programme. Breakthrough designation December 2024. Follows the MSK cohort (Cercek, NEJM 2022; >40 consecutive complete responses).","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05723562","url":"https://clinicaltrials.gov/study/NCT05723562"},{"label":"GSK priority review announcement","url":"https://www.gsk.com/en-gb/media/press-releases/jemperli-dostarlimab-accepted-for-priority-review-by-the-us-fda/"}],"tags":[],"related":[],"cancers":["colorectal","msi-high-colorectal","rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab"],"companies":[],"institutions":["mskcc"],"pathways":[],"terms":["msi","clinical-complete-response"],"trials":[],"people":["andrea-cercek"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05723562","phase":"2","setting":"Untreated stage II/III dMMR/MSI-H locally advanced rectal cancer: dostarlimab monotherapy for 6 months, no surgery or radiation if complete response","sponsor":"GSK","result":"Primary endpoint (sustained cCR at 12 months) met; rates pending congress presentation.","started":"2023-04-03","startedType":"actual","yearReported":2026,"enrolled":154,"enrolledBasis":"registry","outcomes":[{"endpoint":"Sustained clinical complete response at 12 months (independent central review)","primary":true,"unit":"%","arms":[{"name":"Dostarlimab monotherapy (single arm)","note":"Primary endpoint met at the interim analysis per the sponsor (13 July 2026); the rate itself is pending congress presentation. Single-arm registrational phase 2."}],"source":"https://www.cancernetwork.com/view/dostarlimab-yields-sustained-complete-responses-in-dmmr-msi-h-rectal-cancer"}],"replication":"Multicentre confirmation of the Memorial Sloan Kettering single-centre cohort (cCR in all 42 evaluable patients, NEJM 2022 / ASCO 2024). FDA granted priority review in August 2026."},{"id":"nct07550088","kind":"trial","name":"BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases","aka":["AgenT-797"],"tldr":"A phase 2 trial of balstilimab and botensilimab in colorectal cancer, run by Darren Sigal, MD, now recruiting.","summary":"BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases is a phase 2, interventional study registered as NCT07550088 by Darren Sigal, MD, with a registry enrolment figure of 17 participants, started 2026-06-10 and due to reach its primary completion in 2028-09. Interventions recorded: Balstilimab (BAL); Botensilimab (BOT); agenT-797. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Overall Response Rate (ORR). Colorectal eligibility wording from the registry: \"* Adults ≥18 years of age with histologically confirmed metastatic colorectal cancer with liver metastases, including evidence of active liver disease if previously treated locally\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07550088","url":"https://clinicaltrials.gov/study/NCT07550088"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["balstilimab","botensilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07550088","phase":"2","setting":"A Single-Arm, Phase II Study Evaluating Combination Balstilimab Plus Botensilimab With AgenT-797 in Previously Treated Patients With pMMR Metastatic CRC With Liver Metastases","sponsor":"Darren Sigal, MD","started":"2026-06-10","startedType":"actual","enrolled":17,"enrolledBasis":"registry","outcomes":[]},{"id":"ballad","kind":"trial","name":"BALLAD","aka":["PRODIGE 33 - BALLAD","PRODIGE 33","GLOBAL BALLAD"],"tldr":"BALLAD is the first randomised trial of chemotherapy after surgery for cancer of the small intestine, a rare tumour whose treatment has been borrowed from colon cancer; it tests both whether chemotherapy helps at all and whether adding oxaliplatin helps, and results are awaited.","summary":"BALLAD (Benefit of Adjuvant chemotherapy for small boweL ADenocarcinoma) is an international phase 3 trial, registered in France as PRODIGE 33 by the Dijon university hospital and run in parallel national registrations through the International Rare Cancers Initiative. Patients with resected stage I to III small bowel adenocarcinoma enter one of two groups: where the benefit of chemotherapy is uncertain they are randomised to observation or six months of LV5FU2, and where chemotherapy is intended they are randomised to LV5FU2 or FOLFOX. The primary endpoint is three-year disease-free survival, with overall survival at seven years.\n\nThe French registry record lists an estimated 100 patients with primary completion in September 2023 and no results; the protocol paper was published in 2019. The corpus's localised small bowel adenocarcinoma page cites BALLAD as the trial that will decide whether adjuvant chemotherapy, currently extrapolated from colon cancer, is justified in stage II disease.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02502370","url":"https://clinicaltrials.gov/study/NCT02502370"}],"tags":["soc-trials"],"related":[],"cancers":["localised-small-bowel-adenocarcinoma","small-bowel"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","leucovorin","folfox","oxaliplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02502370","phase":"3","setting":"Resected stage I to III small bowel adenocarcinoma: an international randomised trial of adjuvant chemotherapy, with observation against fluorouracil and leucovorin (LV5FU2) where the benefit of chemotherapy is uncertain, and LV5FU2 against FOLFOX where chemotherapy is intended, with three-year disease-free survival as the primary endpoint","sponsor":"Centre Hospitalier Universitaire Dijon (PRODIGE)","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"barbican","kind":"trial","name":"BARBICAN","aka":[],"tldr":"BARBICAN, run from Barts in London, tests whether adding the AKT-blocking tablet ipatasertib to pre-operative chemotherapy and atezolizumab makes more triple-negative tumours disappear. It has finished recruiting 146 women and is due to report in 2026.","summary":"BARBICAN (NCT05498896) is a randomised open-label phase 2 trial in 146 women with triple-negative breast cancer, sponsored by Queen Mary University of London with the West German Study Group, MedSIR and Roche, comparing neoadjuvant chemotherapy (paclitaxel, then doxorubicin and cyclophosphamide) with atezolizumab, with or without ipatasertib; the primary endpoint is pathological complete response. It opened in December 2018 and the registry lists primary completion in August 2026 with the trial active, not recruiting. Its context is the failure of AKT inhibition in metastatic triple-negative disease (IPATunity130 for ipatasertib, CAPItello-290 for capivasertib) and of atezolizumab in early disease (NeoTRIP, GeparDouze, ALEXANDRA), so a positive result would need confirmation.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05498896","url":"https://clinicaltrials.gov/study/NCT05498896"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","pi3k-akt-mtor-inhibitors","cytotoxic-chemotherapy"],"targets":["akt"],"drugs":["ipatasertib","atezolizumab","paclitaxel","doxorubicin","cyclophosphamide"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["pcr"],"trials":["ipatunity130","neotrip","nct03997123"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK site (registry): Barts Health NHS Trust, London."],"nct":"NCT05498896","phase":"2","setting":"Triple-negative breast cancer: randomised open-label phase 2 of neoadjuvant paclitaxel then doxorubicin and cyclophosphamide with atezolizumab, with or without the AKT inhibitor ipatasertib, Barts Health London","sponsor":"Queen Mary University of London, with WSG, MedSIR and Roche","started":"2018-12-19","startedType":"actual","enrolled":146,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06483555","kind":"trial","name":"Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel","aka":["PANGEA"],"tldr":"A phase 1/2 trial of gemcitabine, nab-paclitaxel, erlotinib, nALIRIFOX (liposomal irinotecan + oxaliplatin + 5-FU/LV) and other drugs in pancreatic cancer, run by UNC Lineberger Comprehensive Cancer Center, now recruiting.","summary":"Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel is a phase 1/2, interventional study registered as NCT06483555 by UNC Lineberger Comprehensive Cancer Center, with a registry enrolment figure of 104 participants, started 2025-02-06 and due to reach its primary completion in 2027-08. Interventions recorded: Gemcitabine; Nab paclitaxel; Erlotinib; NALIRIFOX; Folfirinox. Conditions listed: Pancreatic Adenocarcinoma; Metastatic Pancreatic Cancer; Basal Cell Neoplasm. Primary outcome: Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE); Dose-limiting toxicity (DLT); Overall survival- classical metastatic pancreatic adenocarcinoma. Pancreatic eligibility wording from the registry: \"* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Histological or cytological evidence/confirmation of unresectable, borderline resectable, or metastatic (basal-like and classical) pancreatic adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06483555","url":"https://clinicaltrials.gov/study/NCT06483555"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["gemcitabine","nab-paclitaxel","erlotinib","nalirifox","folfirinox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06483555","phase":"1/2","setting":"Subjects With Advanced Basal-like Pancreatic Adenocarcinoma Treated With Gemcitabine, Erlotinib and Nab-paclitaxel (PANGEA) Versus Subjects With Classical Pancreatic Adenocarcinoma Treated With Triplet Standard of Care Therapy.","sponsor":"UNC Lineberger Comprehensive Cancer Center","started":"2025-02-06","startedType":"actual","enrolled":104,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02568267","kind":"trial","name":"Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangeme","aka":["STARTRK-2"],"tldr":"A phase 2 trial of Entrectinib in colorectal cancer and melanoma, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) is a phase 2 interventional study registered as NCT02568267 by Hoffmann-La Roche, with 534 participants enrolled, started 2015-11-19 and due to reach its primary completion in 2027-06-30. Interventions recorded: Entrectinib. Conditions listed: Breast Cancer, Cholangiocarcinoma, Colorectal Cancer, Head and Neck Neoplasms. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02568267","url":"https://clinicaltrials.gov/study/NCT02568267"},{"label":"Entrectinib integrated analysis (Lancet Oncology 2020)","url":"https://doi.org/10.1016/S1470-2045(19)30691-6"},{"label":"NICE TA643: entrectinib for treating ROS1-positive advanced non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta643"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","melanoma","nsclc","sclc","ovarian","ros1-positive-nsclc","ntrk-fusion-nsclc","alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["entrectinib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":["profile-1001-ros1","nct03093116"],"people":[],"bottlenecks":[],"keyPapers":["paper-drilon-entrectinib-ros1-lancet-oncol-2020"],"journals":[],"dependsOn":[],"notes":["The integrated analysis of ALKA-372-001, STARTRK-1 and STARTRK-2 is the basis of the entrectinib approvals. It pooled patients aged 18 or over with metastatic or locally advanced NTRK1, NTRK2 or NTRK3 fusion-positive solid tumours who received at least 600 mg of entrectinib daily and had had no previous TRK inhibitor, with objective response and duration of response by blinded independent central review as the primary endpoints (Lancet Oncology 2020). Entrectinib crosses the blood-brain barrier, which is why it is preferred to crizotinib in ROS1-positive lung cancer with brain metastases. NICE TA643 (12 August 2020) recommends entrectinib for ROS1-positive advanced non-small-cell lung cancer."],"nct":"NCT02568267","phase":"2","setting":"An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements","sponsor":"Hoffmann-La Roche","started":"2015-11-19","startedType":"actual","enrolled":534,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04579380","kind":"trial","name":"Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations","aka":[],"tldr":"A phase 2 trial of Tucatinib, Trastuzumab and Fulvestrant in endometrial cancer, cervical cancer, biliary tract cancer and non-small-cell lung cancer, run by Seagen, a wholly owned subsidiary of Pfizer, active and no longer recruiting.","summary":"Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations is a phase 2 interventional study registered as NCT04579380 by Seagen, a wholly owned subsidiary of Pfizer, with 217 participants enrolled, started 2021-01-11 and due to reach its primary completion in 2023-11-01. Interventions recorded: tucatinib, trastuzumab and fulvestrant. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04579380","url":"https://clinicaltrials.gov/study/NCT04579380"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial","cervical","cholangiocarcinoma","nsclc","her2-mutant-nsclc"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["tucatinib","trastuzumab","fulvestrant"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04579380-j-clin-oncol-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04579380","phase":"2","setting":"A Phase 2 Basket Study of Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations","sponsor":"Seagen, a wholly owned subsidiary of Pfizer","started":"2021-01-11","startedType":"actual","yearReported":2024,"enrolled":217,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed Objective Response Rate (cORR) as Assessed by Investigator","primary":true,"unit":"%","arms":[{"name":"Tucatinib+Trastuzumab (Cohort 1)","n":11,"value":27.3,"note":"90% CI 7.9 to 56.4; Figures from the ClinicalTrials.gov results section (first posted 2024-11-13), not from a publication"},{"name":"Tucatinib+Trastuzumab (Cohort 2)","n":30,"value":13.3,"note":"90% CI 4.7 to 28.0"},{"name":"Tucatinib+Trastuzumab (Cohort 3)","n":30,"value":46.7,"note":"90% CI 30.8 to 63.0"},{"name":"Tucatinib+Trastuzumab (Cohort 4)","n":25,"value":8,"note":"90% CI 1.4 to 23.1"},{"name":"Tucatinib+Trastuzumab (Cohort 5)","n":12,"value":8.3,"note":"90% CI 0.4 to 33.9"},{"name":"Tucatinib+Trastuzumab (Cohort 6)","n":31,"value":22.6,"note":"90% CI 11.1 to 38.3"},{"name":"Tucatinib+Trastuzumab (Cohort 7)","n":13,"value":0,"note":"90% CI 0.0 to 20.6"},{"name":"Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)","n":31,"value":41.9,"note":"90% CI 26.9 to 58.2"},{"name":"Tucatinib+Trastuzumab (Cohort 9)","n":29,"value":10.3,"note":"90% CI 2.9 to 24.6"}],"source":"https://clinicaltrials.gov/study/NCT04579380?tab=results"}]},{"id":"nct06123884","kind":"trial","name":"BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer","aka":[],"tldr":"A phase 2/3 trial of Cisplatin, Bevacizumab, Carboplatin in cervical cancer, run by Bio-Thera Solutions, now recruiting.","summary":"BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer is a phase 2/3 interventional study registered as NCT06123884 by Bio-Thera Solutions, with 526 participants planned, started 2023-12-13 and due to reach its primary completion in 2026-09. Interventions recorded: Recombinant humanized anti-PD-1 monoclonal antibody injection, Cisplatin, Bevacizumab Injection, carboplatin, Paclitaxel for Injection. Conditions listed: Cervical Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06123884","url":"https://clinicaltrials.gov/study/NCT06123884"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["cisplatin","bevacizumab","carboplatin","paclitaxel"],"companies":["bio-thera-solutions"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06123884","phase":"2/3","setting":"A Phase II/III Study to Evaluate the Safety and Efficacy of BAT1308 Combined with Platinum-Based Chemotherapy ± Bevacizumab As First-Line Therapy for PD-L1-Positive (CPS ≥ 1) Persistent, Recurrent or Metastatic Cervical Cancer","sponsor":"Bio-Thera Solutions","started":"2023-12-13","startedType":"actual","enrolled":526,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07469774","kind":"trial","name":"BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by Biocity Biopharmaceutics Co., Ltd., now recruiting.","summary":"BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT07469774 by Biocity Biopharmaceutics Co., Ltd., with 111 participants planned, started 2026-03-31 and due to reach its primary completion in 2027-12-31. Interventions recorded: BC3195 and Pembrolizumab/KEYTRUDA®.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07469774","url":"https://clinicaltrials.gov/study/NCT07469774"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07469774","phase":"1/2","setting":"A Phase 1/2, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors","sponsor":"Biocity Biopharmaceutics Co., Ltd.","started":"2026-03-31","startedType":"actual","enrolled":111,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07108309","kind":"trial","name":"BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer","aka":["AREAL"],"tldr":"A phase 2 trial of BCD-236 in triple-negative breast cancer, run by Biocad, now recruiting.","summary":"BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer is a phase 2 interventional study registered as NCT07108309 by Biocad, with 124 participants planned, started 2024-07-15 and due to reach its primary completion in 2025-12. Interventions recorded: BCD-236 and Chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07108309","url":"https://clinicaltrials.gov/study/NCT07108309"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["biocad"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07108309","phase":"2","setting":"A Randomized, Open-label, Comparative Clinical Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer","sponsor":"Biocad","started":"2024-07-15","startedType":"actual","enrolled":124,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05943106","kind":"trial","name":"BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants","aka":["PATAPSCO"],"tldr":"A phase 3 trial of Durvalumab in bladder & urothelial cancer, run by AstraZeneca, active and no longer recruiting.","summary":"BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants is a phase 3 interventional study registered as NCT05943106 by AstraZeneca, with 100 participants enrolled, started 2023-08-11 and due to reach its primary completion in 2025-06-16. Interventions recorded: Durvalumab and BCG.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05943106","url":"https://clinicaltrials.gov/study/NCT05943106"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab"],"companies":["astrazeneca","parexel"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05943106","phase":"3","setting":"A Phase IIIb Open-Label, Single-Arm, Multi-Center, US Study of Bacillus Calmette-Guerin (BCG) Administered in Combination With Durvalumab in Adult BCG-naïve, High-risk Non-Muscle- Invasive Bladder Cancer Participants (PATAPSCO)","sponsor":"AstraZeneca","started":"2023-08-11","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04271644","kind":"trial","name":"BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease","aka":[],"tldr":"A phase 1/2 trial of BCMA CAR-T cells in multiple myeloma, run by Chongqing Precision Biotech Co., Ltd, now recruiting.","summary":"BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease is a phase 1/2 interventional study registered as NCT04271644 by Chongqing Precision Biotech Co., Ltd, with 80 participants planned, started 2019-04-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: BCMA CAR-T cells.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04271644","url":"https://clinicaltrials.gov/study/NCT04271644"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["chongqing-precision-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04271644","phase":"1/2","setting":"BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease","sponsor":"Chongqing Precision Biotech Co., Ltd","started":"2019-04-01","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"beacon-crc","kind":"trial","name":"BEACON CRC","aka":[],"tldr":"BEACON was the first trial to show that blocking BRAF works in bowel cancer once the escape route through EGFR is blocked too: encorafenib with cetuximab lengthened life and shrank ten times as many tumours as chemotherapy.","summary":"BEACON CRC randomised 665 patients with BRAF V600E-mutant metastatic colorectal cancer that had progressed after one or two regimens to encorafenib, binimetinib and cetuximab (triplet), encorafenib and cetuximab (doublet), or investigator-choice irinotecan or FOLFIRI with cetuximab. Earlier BRAF inhibitor monotherapy had failed in this disease because loss of BRAF signalling releases feedback activation of EGFR, which the antibody blocks.\n\nIn the updated analysis median overall survival was 9.3 months with the triplet and 9.3 months with the doublet against 5.9 months with control; confirmed response rates were 27 percent, 20 percent and 2 percent. The MEK inhibitor added toxicity without a survival gain, so the doublet became the regimen taken forward.\n\nThe FDA approved encorafenib with cetuximab for previously treated BRAF V600E colorectal cancer in April 2020, the first targeted therapy for this subtype, and BREAKWATER then moved the doublet, with FOLFOX, into first-line treatment.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02928224","url":"https://clinicaltrials.gov/study/NCT02928224"},{"label":"New England Journal of Medicine 2019","url":"https://doi.org/10.1056/NEJMoa1908075"},{"label":"Journal of Clinical Oncology 2021 (updated survival)","url":"https://doi.org/10.1200/JCO.20.02088"}],"tags":[],"related":[],"cancers":["colorectal","braf-v600e-colorectal"],"sections":[],"technologies":["kinase-inhibitors","monoclonal-antibody"],"targets":["braf","egfr","mek"],"drugs":["encorafenib","binimetinib","cetuximab","folfiri","irinotecan"],"companies":["pfizer"],"institutions":[],"pathways":["ras-mapk"],"terms":[],"trials":["swog-s1406"],"people":["scott-kopetz","josep-tabernero","elena-elez"],"bottlenecks":[],"keyPapers":["paper-venderbosch-mmr-braf-metastatic-colorectal-pooled-ccr-2014","paper-jones-non-v600-braf-colorectal-jco-2017","paper-tabernero-j-clin-oncol","paper-kopetz-beacon-encorafenib-braf-colorectal-nejm-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02928224","phase":"3","setting":"BRAF V600E-mutant metastatic colorectal cancer after one or two prior lines: encorafenib plus cetuximab with or without binimetinib, versus irinotecan-based chemotherapy plus cetuximab","sponsor":"Pfizer (Array BioPharma)","result":"Median overall survival 9.3 months (encorafenib-cetuximab, with or without binimetinib) vs 5.9 months (chemotherapy plus cetuximab); response rate 20% (doublet) vs 2%.","started":"2016-10-13","startedType":"actual","yearReported":2019,"enrolled":665,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (updated analysis)","primary":true,"unit":"months","arms":[{"name":"Encorafenib + binimetinib + cetuximab","n":224,"value":9.3},{"name":"Encorafenib + cetuximab","n":220,"value":9.3},{"name":"Chemotherapy + cetuximab","n":221,"value":5.9}],"source":"https://doi.org/10.1200/JCO.20.02088"},{"endpoint":"Confirmed objective response rate","unit":"%","arms":[{"name":"Encorafenib + binimetinib + cetuximab","n":224,"value":27},{"name":"Encorafenib + cetuximab","n":220,"value":20},{"name":"Chemotherapy + cetuximab","n":221,"value":2}],"source":"https://doi.org/10.1200/JCO.20.02088"}],"replication":"BREAKWATER replicated the biology in first line with a larger survival gain; the earlier SWOG S1406 trial had shown the same EGFR-feedback rationale with vemurafenib, irinotecan and cetuximab."},{"id":"nct07193511","kind":"trial","name":"BEACON-1: Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (AVZO-103-1001)","aka":["BEACON-1"],"tldr":"A phase 1/2 trial of AVZO-103 in bladder & urothelial cancer, run by Avenzo Therapeutics, Inc., now recruiting.","summary":"BEACON-1: Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (AVZO-103-1001) is a phase 1/2 interventional study registered as NCT07193511 by Avenzo Therapeutics, Inc., with 355 participants planned, started 2025-10-02 and due to reach its primary completion in 2030-03. Interventions recorded: AVZO-103 and Combination Agent.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07193511","url":"https://clinicaltrials.gov/study/NCT07193511"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["avenzo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07193511","phase":"1/2","setting":"A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-103, a Nectin4/Trop2 ADC, as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","sponsor":"Avenzo Therapeutics, Inc.","started":"2025-10-02","startedType":"actual","enrolled":355,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07486817","kind":"trial","name":"Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab","aka":["Beamion 44"],"tldr":"A phase 2 trial of Zongertinib, Cisplatin, Carboplatin, Pemetrexed and Pembrolizumab in non-small-cell lung cancer, run by Boehringer Ingelheim, now recruiting.","summary":"Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab is a phase 2 interventional study registered as NCT07486817 by Boehringer Ingelheim, with 60 participants planned, started 2026-06-04 and due to reach its primary completion in 2027-08-12. Interventions recorded: Zongertinib, Cisplatin, Carboplatin, Pemetrexed and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07486817","url":"https://clinicaltrials.gov/study/NCT07486817"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["zongertinib","cisplatin","carboplatin","pemetrexed","pembrolizumab"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07486817","phase":"2","setting":"Beamion 44: A Randomized, Open-label, Multi-center Phase IIa Platform Trial to Evaluate the Safety and Tolerability of Zongertinib Plus Platinum-based Doublet Chemotherapy With or Without Pembrolizumab (and Potential Other Combinations) in Treatment-naïve Patients With Locally Advanced/Metastatic Non-squamous NSCLC With Activating HER2 Mutations","sponsor":"Boehringer Ingelheim","started":"2026-06-04","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06324357","kind":"trial","name":"Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People Wit","aka":["Beamion BCGC-1"],"tldr":"A phase 1/2 trial of Zongertinib, Trastuzumab deruxtecan, Trastuzumab emtansine in colorectal cancer, run by Boehringer Ingelheim, now recruiting.","summary":"Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread is a phase 1/2 interventional study registered as NCT06324357 by Boehringer Ingelheim, with 768 participants planned, started 2024-06-28 and due to reach its primary completion in 2029-01-08. Interventions recorded: Zongertinib, Trastuzumab deruxtecan, Trastuzumab emtansine, Trastuzumab, Capecitabine. Conditions listed: Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06324357","url":"https://clinicaltrials.gov/study/NCT06324357"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","her2-amplified-colorectal"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["zongertinib","trastuzumab-deruxtecan","trastuzumab-emtansine","trastuzumab","capecitabine","folfox"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06324357","phase":"1/2","setting":"Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)","sponsor":"Boehringer Ingelheim","started":"2024-06-28","startedType":"actual","enrolled":768,"enrolledBasis":"registry","outcomes":[]},{"id":"beamion-lung-1","kind":"trial","name":"Beamion LUNG-1","aka":[],"tldr":"Beamion LUNG-1 showed that zongertinib, a pill that blocks mutant HER2 while sparing EGFR, shrinks about seven in ten HER2-mutant lung cancers after chemotherapy, and it became the first oral HER2 drug approved for lung cancer.","summary":"Beamion LUNG-1 enrolled patients with advanced HER2-mutant non-small-cell lung cancer into a dose-finding phase and then expansion cohorts: previously treated patients naive to HER2-directed therapy, patients who had received a HER2 antibody-drug conjugate, and patients with non-tyrosine-kinase-domain mutations. Earlier HER2 inhibitors such as poziotinib and pyrotinib had produced modest responses with heavy EGFR-mediated diarrhoea and rash.\n\nIn the primary cohort of 75 previously treated patients the confirmed response rate was 71 percent, and 48 percent in 31 patients who had already received a HER2 antibody-drug conjugate. Diarrhoea and rash were mostly low grade and liver enzyme rises were the main reason for dose changes; interstitial lung disease was rare.\n\nThe FDA granted accelerated approval to zongertinib in August 2025 for previously treated HER2-mutant lung cancer. Beamion LUNG-2 is comparing it with standard first-line chemoimmunotherapy.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04886804","url":"https://clinicaltrials.gov/study/NCT04886804"},{"label":"New England Journal of Medicine 2025","url":"https://doi.org/10.1056/NEJMoa2503704"}],"tags":[],"related":[],"cancers":["nsclc","her2-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors","her2-tyrosine-kinase-inhibitors"],"targets":["her2"],"drugs":["zongertinib","trastuzumab-deruxtecan"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":["hepatotoxicity"],"trials":[],"people":["john-heymach"],"bottlenecks":[],"keyPapers":["paper-beamion-lung-1-zongertinib-nejm-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04886804","phase":"1/2","setting":"Previously treated advanced HER2 (ERBB2)-mutant non-small-cell lung cancer: zongertinib, an oral HER2-selective tyrosine kinase inhibitor, in cohorts by prior HER2-directed therapy","sponsor":"Boehringer Ingelheim","result":"Confirmed response rate 71% in 75 previously treated patients naive to HER2-directed therapy; 48% after a HER2 antibody-drug conjugate; FDA accelerated approval August 2025.","started":"2021-07-02","startedType":"actual","yearReported":2025,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed objective response rate","primary":true,"unit":"%","arms":[{"name":"Zongertinib, previously treated, no prior HER2-directed therapy","n":75,"value":71},{"name":"Zongertinib after a HER2 antibody-drug conjugate","n":31,"value":48}],"source":"https://doi.org/10.1056/NEJMoa2503704"}],"replication":"SOHO-01 (sevabertinib) reported high response rates with a second HER2-selective inhibitor; Beamion LUNG-2 (NCT06151574) is the confirmatory trial."},{"id":"nct06151574","kind":"trial","name":"Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment","aka":["Beamion LUNG-2"],"tldr":"A phase 3 trial of Zongertinib, Pembrolizumab, Cisplatin, Carboplatin and Pemetrexed in non-small-cell lung cancer, run by Boehringer Ingelheim, active and no longer recruiting.","summary":"Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment is a phase 3 interventional study registered as NCT06151574 by Boehringer Ingelheim, with 428 participants enrolled, started 2024-02-09 and due to reach its primary completion in 2026-09-02. Interventions recorded: zongertinib, pembrolizumab, cisplatin, carboplatin and pemetrexed.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06151574","url":"https://clinicaltrials.gov/study/NCT06151574"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","her2-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["zongertinib","pembrolizumab","cisplatin","carboplatin","pemetrexed"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06151574","phase":"3","setting":"Beamion LUNG 2: A Phase III, Open-label, Randomized, Active-controlled, Multi-centre Trial Evaluating Orally Administered Zongertinib (BI 1810631) Compared With Standard of Care as First-line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harbouring HER2 Tyrosine Kinase Domain Mutations","sponsor":"Boehringer Ingelheim","started":"2024-02-09","startedType":"actual","enrolled":428,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07195695","kind":"trial","name":"Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutati","aka":["Beamion LUNG-3"],"tldr":"A phase 3 trial of Zongertinib, Pembrolizumab, Atezolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Boehringer Ingelheim, now recruiting.","summary":"Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations is a phase 3 interventional study registered as NCT07195695 by Boehringer Ingelheim, with 400 participants planned, started 2026-01-16 and due to reach its primary completion in 2032-02-26. Interventions recorded: Zongertinib, Pembrolizumab, Atezolizumab, Durvalumab, Nivolumab. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07195695","url":"https://clinicaltrials.gov/study/NCT07195695"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","her2-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["zongertinib","pembrolizumab","atezolizumab","durvalumab","nivolumab"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07195695","phase":"3","setting":"Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations","sponsor":"Boehringer Ingelheim","started":"2026-01-16","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06581432","kind":"trial","name":"Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations","aka":["Beamion PANTUMOR-1"],"tldr":"A phase 2 trial of Zongertinib in advanced solid tumours, run by Boehringer Ingelheim, now recruiting.","summary":"Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations is a phase 2 interventional study registered as NCT06581432 by Boehringer Ingelheim, with 588 participants planned, started 2024-10-11 and due to reach its primary completion in 2028-11-30. Interventions recorded: Zongertinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06581432","url":"https://clinicaltrials.gov/study/NCT06581432"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["zongertinib"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06581432","phase":"2","setting":"Beamion PANTUMOR-1: A Phase II, Multicentre, Multicohort, Open-label Trial to Evaluate the Efficacy and Safety of Oral Zongertinib (BI 1810631) for the Treatment of Selected HER2-mutated or Overexpressed/Amplified Solid Tumours","sponsor":"Boehringer Ingelheim","started":"2024-10-11","startedType":"actual","enrolled":588,"enrolledBasis":"registry","outcomes":[]},{"id":"beat-aml-master-trial","kind":"trial","name":"Beat AML Master Trial","aka":["Beat AML","Beat AML Master Clinical Trial","LLS Beat AML"],"tldr":"Beat AML proved that a newly diagnosed leukaemia can be fully genetically typed within a week and the patient started on a drug aimed at their particular mutation, instead of the same chemotherapy for everyone. Older patients treated this way lived longer than those given standard care.","summary":"The Beat AML Master Trial opened in November 2016, sponsored by the Leukemia & Lymphoma Society through a dedicated company and led by John Byrd with Brian Druker's Beat AML research programme and Ross Levine among its scientific leaders. Patients aged 60 or older with suspected new acute myeloid leukaemia consent before diagnosis is confirmed; bone marrow is sent for cytogenetics and next-generation sequencing, and a treatment assignment is returned within seven days according to a hierarchy of mutations (FLT3, IDH1, IDH2, TP53, core-binding factor, NPM1 and others), each with its own phase 1b or 2 sub-study of a targeted drug such as gilteritinib, ivosidenib or enasidenib, often combined with azacitidine or later venetoclax.\n\nThe feasibility and early efficacy report in Nature Medicine in 2020 covered the first 487 patients: results came back within seven days for nearly all, most eligible patients could be assigned to a sub-study, and those treated on Beat AML arms had a median overall survival of 12.8 months compared with 3.9 months among patients who chose standard care, with the caveat that the comparison was not randomised. Sub-studies have since reported individually, including combinations for TP53-mutant and complex-karyotype disease, and the trial has expanded to include younger patients and new drug classes such as menin inhibitors.\n\nBeat AML changed the timetable of leukaemia care: it showed that waiting a week for genomics is safe in most older patients and that assignment by mutation at diagnosis is workable across many centres, which is the premise of the NCI's myeloMATCH. Whether the individual sub-study drugs improve survival against modern standards such as azacitidine with venetoclax is being answered arm by arm.","status":"recruiting","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03013998","url":"https://clinicaltrials.gov/study/NCT03013998"},{"label":"Burd et al., Nature Medicine 2020: precision medicine treatment in acute myeloid leukemia using prospective genomic profiling, feasibility and preliminary efficacy of the Beat AML Master Trial","url":"https://doi.org/10.1038/s41591-020-1089-8"}],"tags":[],"related":["leukemia-lymphoma-society"],"cancers":["aml"],"sections":[],"technologies":["cgp","idh-inhibitors","bcl2-inhibitors","kinase-inhibitors","menin-inhibitors"],"targets":[],"drugs":["azacitidine","venetoclax","gilteritinib","enasidenib","ivosidenib","pevonedistat"],"companies":[],"institutions":["osu-james","ohsu-knight","mskcc"],"pathways":[],"terms":["master-protocol","basket-umbrella-platform"],"trials":["myelomatch"],"people":["john-byrd","brian-druker","ross-levine"],"bottlenecks":["b-trial-design"],"keyPapers":["paper-burd-nat-med"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03013998","phase":"platform","setting":"Newly diagnosed acute myeloid leukaemia in patients aged 60 and over: cytogenetic and genomic results returned within seven days assign each patient to a mutation-defined sub-study of targeted therapy, alone or with azacitidine or venetoclax","sponsor":"Leukemia & Lymphoma Society (Beat AML, LLC)","result":"Genomic assignment within seven days was feasible; patients treated on Beat AML sub-studies had median overall survival of 12.8 months against 3.9 months for those choosing standard care (non-randomised comparison).","started":"2016-11","yearReported":2020,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (non-randomised comparison)","unit":"months","arms":[{"name":"Beat AML sub-study treatment","value":12.8},{"name":"Standard of care by patient choice","value":3.9}],"source":"https://doi.org/10.1038/s41591-020-1089-8"}]},{"id":"beat-meso","kind":"trial","name":"BEAT-meso (ETOP 13-18)","aka":[],"tldr":"Adding atezolizumab to bevacizumab-chemotherapy slowed progression but did not lengthen survival overall; it did help patients with non-epithelioid tumours.","summary":"BEAT-meso, ETOP trial 13-18, NCT03762018, sponsored by ETOP and reported at ASCO 2024, tested adding atezolizumab to bevacizumab plus carboplatin and pemetrexed as first-line treatment for advanced pleural mesothelioma, and found that it slowed progression but did not lengthen survival overall, though it did help patients with non-epithelioid tumours. It randomised 400 patients, missed its primary overall survival endpoint in the whole population, improved progression-free survival, and showed a survival benefit in the pre-specified non-epithelioid subgroup with a clear interaction by histology. OnCo links it to mesothelioma, atezolizumab, pemetrexed, the epithelioid versus sarcomatoid term and the ETOP IBCSG Partners Foundation, and the non-epithelioid finding echoes CheckMate 743. Whether histology should now decide who gets immunotherapy in mesothelioma is the open question.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03762018","url":"https://clinicaltrials.gov/study/NCT03762018"},{"label":"ASCO 2024 LBA8002","url":"https://ascopubs.org/doi/10.1200/JCO.2024.42.17_suppl.LBA8002"}],"tags":[],"related":[],"cancers":["mesothelioma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab","pemetrexed"],"companies":["etop-ibcsg"],"institutions":[],"pathways":[],"terms":["epithelioid-vs-sarcomatoid"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03762018","phase":"3","setting":"Advanced pleural mesothelioma, first line: bevacizumab + carboplatin-pemetrexed ± atezolizumab","sponsor":"ETOP","result":"OS not significantly improved overall; benefit in non-epithelioid subgroup.","started":"2019-04-30","startedType":"actual","yearReported":2024,"enrolled":400,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Atezolizumab + bevacizumab + carboplatin-pemetrexed","n":200,"value":20.5,"note":"Not significant; primary endpoint not met"},{"name":"Bevacizumab + carboplatin-pemetrexed","n":200,"value":18.1}],"hr":0.84,"ci":[0.66,1.06],"p":"0.14","source":"https://doi.org/10.1016/j.annonc.2024.12.014"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Atezolizumab + bevacizumab + carboplatin-pemetrexed","value":9.2},{"name":"Bevacizumab + carboplatin-pemetrexed","value":7.6}],"hr":0.72,"ci":[0.59,0.89],"p":"0.0021","source":"https://doi.org/10.1016/j.annonc.2024.12.014"},{"endpoint":"Overall survival, non-epithelioid histology","unit":"months","arms":[{"name":"Atezolizumab + bevacizumab + carboplatin-pemetrexed","note":"Pre-specified histology subgroup; interaction p = 0.012 (epithelioid HR 1.01, 95% CI 0.77-1.32)"},{"name":"Bevacizumab + carboplatin-pemetrexed"}],"hr":0.51,"ci":[0.32,0.8],"source":"https://doi.org/10.1016/j.annonc.2024.12.014"}],"replication":"Primary OS endpoint missed; the non-epithelioid benefit echoes CheckMate 743, where ipilimumab-nivolumab helped non-epithelioid disease most. Not independently replicated."},{"id":"beatcc","kind":"trial","name":"BEATcc / ENGOT-Cx10 / GOG-3030","aka":[],"tldr":"A second immunotherapy confirmed that adding a checkpoint inhibitor to chemotherapy plus bevacizumab extends life in advanced cervical cancer.","summary":"BEATcc, also ENGOT-Cx10 and GOG-3030, trial NCT03556839 sponsored by GEICO and Roche and published in the Lancet in 2024, was the second immunotherapy trial to confirm that adding a checkpoint inhibitor to chemotherapy plus bevacizumab extends life in metastatic, persistent or recurrent cervical cancer. It randomised 410 patients to atezolizumab or nothing added to platinum, paclitaxel and bevacizumab, met its primary progression-free and overall survival endpoints with the longest median survival reported in this setting, and showed benefit irrespective of PD-L1 status. OnCo links it to cervical cancer, PD-L1 and VEGF as targets, atezolizumab, bevacizumab, cisplatin, paclitaxel and Antonio González-Martín. Regulatory approval status differs by region, and whether a PD-L1 antibody offers anything over pembrolizumab in this setting is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03556839","url":"https://clinicaltrials.gov/study/NCT03556839"},{"label":"Lancet 2024","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02517-3/fulltext"}],"tags":[],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1","vegf"],"drugs":["atezolizumab","bevacizumab","cisplatin","paclitaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["antonio-gonzalez-martin"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03556839","phase":"3","setting":"Metastatic, persistent, or recurrent cervical cancer, first line: atezolizumab + cisplatin/carboplatin-paclitaxel + bevacizumab vs the same without atezolizumab","sponsor":"GEICO / Roche","result":"OS 32.1 vs 22.8 months (HR 0.68).","started":"2018-09-25","startedType":"actual","yearReported":2023,"enrolled":410,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Atezolizumab + chemo + bev","n":206,"value":13.7},{"name":"Chemo + bev","n":204,"value":10.4}],"hr":0.62,"ci":[0.49,0.78],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02517-3/fulltext"},{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Atezolizumab + chemo + bev","value":32.1},{"name":"Chemo + bev","value":22.8}],"hr":0.68,"ci":[0.52,0.88],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02517-3/fulltext"}]},{"id":"nct07490119","kind":"trial","name":"Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of cetuximab in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer is a phase 2, interventional study registered as NCT07490119 by Fudan University, with a registry enrolment figure of 31 participants, started 2026-06-01 and due to reach its primary completion in 2028-06-01. Interventions recorded: Becotatug Vedotin; Cetuximab. Conditions listed: RAS Wild Type mCRC. Primary outcome: ORR. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed metastatic RAS wild-type colorectal cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07490119","url":"https://clinicaltrials.gov/study/NCT07490119"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07490119","phase":"2","setting":"Efficacy and Safety of Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer: A Single-arm, Open-label, Single-center Phase II Clinical Study","sponsor":"Fudan University","started":"2026-06-01","startedType":"estimated","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07649980","kind":"trial","name":"Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II","aka":[],"tldr":"A phase 2 trial of pucotenlimab in gallbladder cancer and other biliary tract cancers, run by HuiKai Li, not yet recruiting.","summary":"Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II is a phase 2 interventional study registered as NCT07649980 by HuiKai Li, with a registry enrolment figure of 30 participants, started 2026-07-01 and due to reach its primary completion in 2029-07-01. Interventions recorded: Becotatug Vedotin, Pucotenlimab. Conditions listed: Biliary Tract Cancer (BTC), EGFR-positive Advanced Biliary Tract Carcinoma. Gallbladder cancer is named in the registry entry: \"2. Histologically or cytologically confirmed advanced biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC); recurrent biliary tr\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07649980","url":"https://clinicaltrials.gov/study/NCT07649980"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pucotenlimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07649980","phase":"2","setting":"Becotatug Vedotin Combined With Pucotenlimab in First-Line Treatment-Failed Advanced Biliary Tract Carcinoma: A Phase II Exploratory Clinical Study","sponsor":"HuiKai Li","started":"2026-07-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07629609","kind":"trial","name":"BEFAST Study, [68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer","aka":["BEFAST"],"tldr":"A phase 2 trial in pancreatic cancer, run by Barbara Malene Fischer, now recruiting.","summary":"BEFAST Study, [68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer is a phase 2, interventional study registered as NCT07629609 by Barbara Malene Fischer, with a registry enrolment figure of 90 participants, started 2024-01-16 and due to reach its primary completion in 2027-01. Interventions recorded: [68Ga]Ga-FAPI-46. Conditions listed: Pancreatic Cancer, Adult; Gastroesophageal Cancer (GC). Primary outcome: Sensitivity of [68Ga]Ga-FAPI-46 Total Body PET/CT. Pancreatic eligibility wording from the registry: \"Patients with suspected pancreatic cancer based on morphological findings on standard imaging\". Sites: Denmark. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07629609","url":"https://clinicaltrials.gov/study/NCT07629609"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07629609","phase":"2","setting":"[68Ga]Ga-FAPI Total Body PET/CT for Improving Diagnostic Sensitivity and Preoperative Staging in Gastroesophageal Cancer and Pancreatic Cancer","sponsor":"Barbara Malene Fischer","started":"2024-01-16","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07195591","kind":"trial","name":"Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care","aka":["BRIDGES"],"tldr":"A phase 3 trial of Temozolomide in glioma & glioblastoma, run by GT Medical Technologies, Inc., now recruiting.","summary":"Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care is a phase 3 interventional study registered as NCT07195591 by GT Medical Technologies, Inc., with 766 participants planned, started 2025-12-10 and due to reach its primary completion in 2031-12. Interventions recorded: GammaTile®, External Beam Radiation Therapy and Temozolomide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07195591","url":"https://clinicaltrials.gov/study/NCT07195591"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":["gt-medical-technologies"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07195591","phase":"3","setting":"Randomized Study of Resection and GammaTile® Followed by Concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant TMZ Versus Standard of Care in Newly Diagnosed Glioblastoma (GBM)","sponsor":"GT Medical Technologies, Inc.","started":"2025-12-10","startedType":"actual","enrolled":766,"enrolledBasis":"registry","outcomes":[]},{"id":"belinda","kind":"trial","name":"BELINDA","aka":[],"tldr":"The one second-line CAR-T trial that failed, a reminder that manufacturing time and trial design can erase a real effect.","summary":"BELINDA, trial NCT03570892 sponsored by Novartis and reported in 2021, was the one second-line CAR-T trial that failed, a reminder that manufacturing time and trial design can erase a real effect. It randomised 322 patients with early-relapsed or refractory aggressive B-cell lymphoma to tisagenlecleucel or salvage chemotherapy and transplant and found no difference in event-free survival, which the record attributes to a long vein-to-vein time of 52 days, permitted crossover chemotherapy before CAR-T and a strict week-twelve event definition. OnCo links it to lymphoma, CAR-T, the pairing of CAR-T before transplant at early relapse and the JULIET, TRANSFORM and ZUMA-7 papers, and it is contradicted by ZUMA-7 and TRANSFORM, which used faster products and no crossover. Whether tisagenlecleucel would have matched them under the same design is the question the trial cannot answer.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03570892","url":"https://clinicaltrials.gov/study/NCT03570892"}],"tags":["lesson:trial-design"],"related":["lymphoma-roadmap","juliet","transcend-nhl-001","lymphoma-ev-manufacturing-time-as-a-trial-endpoint"],"cancers":["dlbcl"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":[],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-belinda-tisagenlecleucel-second-line-nejm-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03570892","phase":"3","setting":"Early-relapsed/refractory aggressive B-cell lymphoma: tisagenlecleucel vs salvage + transplant","sponsor":"Novartis","result":"EFS HR 1.07 (negative).","started":"2019-05-09","startedType":"actual","yearReported":2021,"enrolled":330,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Tisagenlecleucel","n":162,"value":3},{"name":"Standard care","n":160,"value":3}],"hr":1.07,"ci":[0.82,1.4],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2116596"}],"replication":"Contradicted by ZUMA-7 and TRANSFORM, which used faster products and no crossover before CAR-T."},{"id":"bellwave-011","kind":"trial","name":"BELLWAVE-011","aka":[],"tldr":"BELLWAVE-011 is Merck's bid to enter frontline CLL with a reversible BTK inhibitor, head to head against two approved covalent drugs.","summary":"BELLWAVE-011, trial NCT06136559 sponsored by Merck, is Merck's bid to enter frontline chronic lymphocytic leukaemia with the reversible BTK inhibitor nemtabrutinib, tested head to head against investigator's choice of ibrutinib or acalabrutinib in previously untreated disease. It is an open-label randomised phase 3 with progression-free survival as the primary endpoint and was recruiting in July 2026, while the companion BELLWAVE-008 compares nemtabrutinib with chemoimmunotherapy in patients without TP53 aberrations. OnCo links it to chronic lymphocytic leukaemia, BTK as a target, nemtabrutinib, ibrutinib and acalabrutinib. Whether a non-covalent inhibitor can beat the approved covalent drugs in the frontline, rather than only after them, is the question it will answer.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06136559","url":"https://clinicaltrials.gov/study/NCT06136559"}],"tags":[],"related":[],"cancers":["cll"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["btk"],"drugs":["nemtabrutinib","ibrutinib","acalabrutinib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06136559","phase":"3","setting":"Previously untreated CLL/SLL: nemtabrutinib vs investigator's choice of ibrutinib or acalabrutinib","sponsor":"Merck","started":"2023-12-13","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"nct07449754","kind":"trial","name":"Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma","aka":[],"tldr":"A phase 2 trial of Cobimetinib in melanoma, run by Hanmi Pharmaceutical Company Limited, now recruiting.","summary":"Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma is a phase 2 interventional study registered as NCT07449754 by Hanmi Pharmaceutical Company Limited, with 45 participants planned, started 2026-02-12 and due to reach its primary completion in 2029-09. Interventions recorded: Belvarafenib, Cobimetinib. Conditions listed: Advanced or Metastatic Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07449754","url":"https://clinicaltrials.gov/study/NCT07449754"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["cobimetinib"],"companies":["hanmi-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07449754","phase":"2","setting":"A Phase 2, Multicenter, Single-Arm Study of Belvarafenib (HM95573) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma","sponsor":"Hanmi Pharmaceutical Company Limited","started":"2026-02-12","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04924075","kind":"trial","name":"Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL","aka":[],"tldr":"A phase 2 trial of Belzutifan in pheochromocytoma and paraganglioma, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015) is a phase 2 interventional study registered as NCT04924075 by Merck Sharp & Dohme LLC, with 355 participants planned, started 2021-08-12 and due to reach its primary completion in 2029-12-27. Interventions recorded: Belzutifan. Conditions listed: Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor, Von Hippel-Lindau Disease, Advanced Gastrointestinal Stromal Tumor. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04924075","url":"https://clinicaltrials.gov/study/NCT04924075"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pheochromocytoma-paraganglioma","pancreatic-net","hereditary-ppgl","metastatic-ppgl"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["belzutifan"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04924075","phase":"2","setting":"A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, Formerly PT2977) Monotherapy in Participants With Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With HIF-2α Related Genetic Alterations","sponsor":"Merck Sharp & Dohme LLC","started":"2021-08-12","startedType":"actual","enrolled":355,"enrolledBasis":"registry","outcomes":[]},{"id":"bespoke-crc","kind":"trial","name":"BESPOKE CRC","aka":["BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer"],"tldr":"Natera's US study in which 1,788 people with bowel cancer had Signatera blood tests after surgery and their doctors could act on the result; it records what changed and what happened, but does not randomise anyone.","summary":"BESPOKE CRC is Natera's prospective observational study of Signatera in resected colorectal cancer. The registry lists 1,788 participants, a start date of 24 April 2020 and a completion date of September 2025, with the overall status not updated. Because doctors chose treatment knowing the result, it can show how often a ctDNA result changes management and how ctDNA-positive and ctDNA-negative patients fare, but not whether acting on the test improves survival; that question belongs to DYNAMIC, CIRCULATE-US and VEGA.","status":"active","asOf":"2026-09-21","links":[{"label":"ClinicalTrials.gov NCT04264702","url":"https://clinicaltrials.gov/study/NCT04264702"}],"tags":["ctdna-roadmap"],"related":["circulate-us","ctdna-tests"],"cancers":["colorectal"],"sections":[],"technologies":["mrd-testing","liquid-biopsy"],"targets":[],"drugs":["signatera"],"companies":["natera"],"institutions":[],"pathways":[],"terms":["mrd","ctdna","tumour-informed-assay"],"trials":["dynamic-iii","altair"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04264702","phase":"observational","setting":"Stage II to IV colorectal cancer after surgery in the United States: Signatera results returned to treating doctors, with treatment decisions and outcomes recorded","sponsor":"Natera, Inc.","started":"2020-04-24","startedType":"actual","enrolled":1788,"enrolledBasis":"registry","outcomes":[]},{"id":"best-bra","kind":"trial","name":"Best-BRA","aka":["Best-BRA pilot trial"],"tldr":"The first randomised comparison of putting a breast implant in front of the chest muscle or behind it. It is a pilot, because the field adopted the newer technique before anyone tested whether women do better with it.","summary":"Best-BRA is a pragmatic two-arm external pilot randomised controlled trial with an embedded QuinteT Recruitment Intervention and economic scoping for resource use. Women who need a mastectomy for breast cancer or risk reduction, elect an implant-based reconstruction and are considered suitable for either placement are randomised 1:1 between sub-pectoral and pre-pectoral reconstruction.\n\nThe outcomes are about feasibility rather than about breasts: recruitment, adherence to allocation, and outcome completion rates, reviewed at twelve months to decide whether a definitive trial can be run. The recruitment intervention runs in two phases, investigating why recruitment is difficult and then acting on what it finds, because randomised trials of reconstructive surgery are notoriously hard to fill.\n\nThe reason the trial exists is the gap the observational studies left. Mesh-assisted sub-pectoral reconstruction became the standard of care and pre-pectoral techniques were then widely adopted on the argument that they reduce postoperative pain, avoid implant animation and improve appearance, but the small observational studies show no clear difference in clinical or patient-reported outcomes and there is no comparative evidence of clinical or cost effectiveness. No Best-BRA results have been published and none are quoted here.","status":"active","asOf":"2026-09-25","links":[{"label":"ISRCTN10081873","url":"https://www.isrctn.com/ISRCTN10081873"},{"label":"Best-BRA protocol (BMJ Open 2021)","url":"https://doi.org/10.1136/bmjopen-2021-050886"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["breast-reconstruction","mastectomy"],"trials":["ibra-study","pre-bra"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN10081873","phase":"2","setting":"Women having mastectomy for breast cancer or risk reduction who elect implant-based reconstruction and are suitable for either technique: sub-pectoral against pre-pectoral immediate implant-based reconstruction, as an external pilot randomised trial with recruitment, adherence to allocation and outcome completion as the outcomes","sponsor":"University of Bristol","enrolledBasis":"registry","outcomes":[]},{"id":"nct07071844","kind":"trial","name":"BETWEEN: Biweekly Bevacizumab + Trifluridine/Tipiracil to Reduce Grade 3-4 Neutropenia in mCRC Patients","aka":["BETWEEN"],"tldr":"A phase 2 trial of trifluridine/tipiracil and bevacizumab (glioblastoma use) in colorectal cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group, not yet recruiting.","summary":"BETWEEN: Biweekly Bevacizumab + Trifluridine/Tipiracil to Reduce Grade 3-4 Neutropenia in mCRC Patients is a phase 2, randomised interventional study registered as NCT07071844 by GERCOR - Multidisciplinary Oncology Cooperative Group, with a registry enrolment figure of 162 participants, started 2025-09 and due to reach its primary completion in 2028-12. Interventions recorded: Trifluridine/tipiracil; Bevacizumab. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: The occurrence of at least one grade 3-4 neutropenia. Colorectal eligibility wording from the registry: \"Histologically proven colorectal adenocarcinoma,\". Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07071844","url":"https://clinicaltrials.gov/study/NCT07071844"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["trifluridine-tipiracil","bevacizumab-glioma"],"companies":["servier","gercor"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07071844","phase":"2","setting":"BEvacizumab Plus Trifluridine/Tipiracil in a Bi-WEEkly Administration to Reduce Grade 3-4 Neutropenia in Patients With mCRC: A Prospective, Multicenter, Comparative, Randomized GERCOR G-124 BETWEEN Phase II Study","sponsor":"GERCOR - Multidisciplinary Oncology Cooperative Group","started":"2025-09","startedType":"estimated","enrolled":162,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07481786","kind":"trial","name":"Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases","aka":[],"tldr":"A phase 3 trial of bevacizumab in lung cancer, run by Sun Yat-sen University, now recruiting.","summary":"Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases is a phase 3, randomised interventional study registered as NCT07481786 by Sun Yat-sen University, with a registry enrolment figure of 220 participants, started 2026-03-20 and due to reach its primary completion in 2029-09-15. Interventions recorded: FSRT; HA-WBRT-SIB; Bevacizumab. Conditions listed: Lung Adenocarcinoma; Brain Metastases; Radiotherapy, Intensity-Modulated; Bevacizumab; Whole-Brain Radiotherapy. Primary outcome: Intracranial Progression-Free Survival (IPFS); Neurocognitive Function failure. Lung eligibility wording from the registry: \"* Pathologically confirmed non-squamous non-small cell lung cancer (adenocarcinoma)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07481786","url":"https://clinicaltrials.gov/study/NCT07481786"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody","sbrt"],"targets":[],"drugs":["bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07481786","phase":"3","setting":"Application of Bevacizumab Combined With Fractionated Stereotactic Radiotherapy (FSRT-Bev) Versus Hippocampus-Avoidant Whole-Brain Radiotherapy With Simultaneous Integrated Boost (HA-WBRT-SIB) in Patients With Extensive Brain Metastases From Lung Adenocarcinoma: A Phase III Randomized Controlled Trial Evaluating Intracranial Control Efficacy and Neurocognitive Function","sponsor":"Sun Yat-sen University","started":"2026-03-20","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04230187","kind":"trial","name":"Bevacizumab Plus mFOLFOXIRI as First-line Treatment for Patients With Unresectable Metastatic Colorectal Cancer","aka":["TRIBE-C"],"tldr":"A phase 3 trial in colorectal cancer, run by Yanhong Deng, active but no longer recruiting.","summary":"Bevacizumab Plus mFOLFOXIRI as First-line Treatment for Patients With Unresectable Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT04230187 by Yanhong Deng, with a registry enrolment figure of 528 participants, started 2020-09-01 and due to reach its primary completion in 2026-09-01. Interventions recorded: mFOLFOXIRI plus Bevacizumab; mFOLFOX6 Plus Bevacizumab. Conditions listed: Colorectal Cancer. Primary outcome: Progression-free survival (PFS). Colorectal eligibility wording from the registry: \"\\- Histological or cytological documentation of adenocarcinoma of the colon or rectum\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04230187","url":"https://clinicaltrials.gov/study/NCT04230187"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04230187","phase":"3","setting":"Bevacizumab Plus mFOLFOXIRI or mFOLFOX-6 as First-line Treatment for Patients With Unresectable Metastatic Colorectal Cancer: a Randomised, Open-label, Phase 3 Trial","sponsor":"Yanhong Deng","started":"2020-09-01","startedType":"actual","enrolled":528,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06642844","kind":"trial","name":"Bevacizumab-based Chemotherapy Adapted to Bevacizumab Pharmacokinetics in 1st-line Treatment","aka":["PHARBEVACOL"],"tldr":"A phase 3 trial in colorectal cancer, run by University Hospital, Tours, now recruiting.","summary":"Bevacizumab-based Chemotherapy Adapted to Bevacizumab Pharmacokinetics in 1st-line Treatment is a phase 3, randomised interventional study registered as NCT06642844 by University Hospital, Tours, with a registry enrolment figure of 244 participants, started 2025-03-04 and due to reach its primary completion in 2028-03-04. Interventions recorded: Avastin, 25 Mg/mL Intravenous Solution. Conditions listed: Unresectable Metastatic Colorectal Cancer. Primary outcome: The primary endpoint is progression-free survival (PFS). Colorectal eligibility wording from the registry: \"* Histologically proven metastatic colorectal adenocarcinoma (on primary tumor and/or metastases) inoperable, well documented, i\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06642844","url":"https://clinicaltrials.gov/study/NCT06642844"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06642844","phase":"3","setting":"Bevacizumab-based Chemotherapy Tailored to the Pharmacokinetics of Bevacizumab in First-line Treatment of Unresectable Metastatic Colorectal Cancer: a Randomized, Multicenter, Double-blind Phase 3 Study","sponsor":"University Hospital, Tours","started":"2025-03-04","startedType":"actual","enrolled":244,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07722754","kind":"trial","name":"Bevacizumab, Sintilimab, Cetuximab and Irinotecan in Refractory RAS Wild-type Metastatic Colorectal Cancer: BOND-4 Trial","aka":["BOND-4"],"tldr":"A phase 2 trial of cetuximab, fOLFIRI (5-FU, leucovorin, irinotecan), bevacizumab (glioblastoma use) and sintilimab in colorectal cancer, run by Guangdong Provincial People's Hospital, now recruiting.","summary":"Bevacizumab, Sintilimab, Cetuximab and Irinotecan in Refractory RAS Wild-type Metastatic Colorectal Cancer: BOND-4 Trial is a phase 2, randomised interventional study registered as NCT07722754 by Guangdong Provincial People's Hospital, with a registry enrolment figure of 160 participants, started 2026-07-23 and due to reach its primary completion in 2028-07-31. Interventions recorded: Cetuximab; Irinotecan; Bevacizumab; Sintilimab. Conditions listed: Colorectal Neoplasms Malignant; Neoplasm, Metastatic. Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"* Metastatic and unresectable colorectal adenocarcinom;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07722754","url":"https://clinicaltrials.gov/study/NCT07722754"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["cetuximab","folfiri","bevacizumab-glioma","sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07722754","phase":"2","setting":"A Randomized, Multi-center, Open-label Phase II Trial of Irinotecan and Cetuximab With or Without the Combination of Bevacizumab and Sintilimab in RAS Wild-type, Irinotecan-refractory Metastatic Colorectal Cancer","sponsor":"Guangdong Provincial People's Hospital","started":"2026-07-23","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07492641","kind":"trial","name":"BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease","aka":["KANDELA-302"],"tldr":"A phase 3 trial testing BGB-43395 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease is a phase 3 interventional study registered as NCT07492641, led by BeOne Medicines, and recruiting on the registry. Official title: An Open-Label, Randomised, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease. Planned enrolment is 1056 participants (estimated). The study started in 2026-05-22 and primary completion is expected in 2029-04. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07492641","url":"https://clinicaltrials.gov/study/NCT07492641"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["bgb-43395"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07492641","phase":"3","setting":"An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease","sponsor":"BeOne Medicines","started":"2026-05-22","startedType":"actual","enrolled":1056,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02706691","kind":"trial","name":"BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer","aka":[],"tldr":"A phase 2 trial of Infigratinib in Head and neck squamous cell carcinoma, run by University of Chicago, recorded as terminated on the registry.","summary":"BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer is a phase 2 interventional study registered as NCT02706691 by University of Chicago, with 1 participants recorded, started 2018-06-01 and due to reach its primary completion in 2019-02-11. Interventions recorded: BGJ398. Conditions recorded: FGFR Gene Amplification, FGFR1 Gene Amplification, FGFR2 Gene Amplification, FGFR2 Gene Mutation, FGFR3 Gene Mutation, Head and Neck Squamous Cell Carcinoma, Human Papillomavirus Infection, Recurrent Head and Neck Carcinoma, Recurrent Nasopharynx Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma.\n\nLinked to the drug Infigratinib because the registry names it among its interventions and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02706691","url":"https://clinicaltrials.gov/study/NCT02706691"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["infigratinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02706691","phase":"2","setting":"Phase IIa Study of the Efficacy of Single Agent BGJ398 (Infigratinib) in FGFR1-3 Translocated, Mutated, or Amplified Squamous Cell Carcinoma of the Head and Neck","sponsor":"University of Chicago","started":"2018-06-01","startedType":"actual","enrolled":1,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04752826","kind":"trial","name":"BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)","aka":["Keynote-D20"],"tldr":"A phase 1/2 trial of Pembrolizumab in ovarian cancer and melanoma, run by BioInvent International AB, now recruiting.","summary":"BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20) is a phase 1/2 interventional study registered as NCT04752826 by BioInvent International AB, with 176 participants planned, started 2021-01-25 and due to reach its primary completion in 2026-12-31. Interventions recorded: BI-1808, Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection. Conditions listed: Advanced Malignancies, Ovarian Cancer, T-cell Lymphoma, Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04752826","url":"https://clinicaltrials.gov/study/NCT04752826"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["bioinvent-international"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04752826","phase":"1/2","setting":"Phase 1/2a Open-Label, Dose-Escalation, Multicenter, FIH, Consecutive-Cohort, Clinical Trial of BI-1808, a Monoclonal Antibody to TNFR 2 as a Single Agent and in Combination With Pembrolizumab (MK-3475-D20) in Subjects With Advanced Malignancies","sponsor":"BioInvent International AB","started":"2021-01-25","startedType":"actual","enrolled":176,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06205706","kind":"trial","name":"BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by BioInvent International AB, active and no longer recruiting.","summary":"BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06205706 by BioInvent International AB, with 35 participants enrolled, started 2023-12-04 and due to reach its primary completion in 2027-07-14. Interventions recorded: BI-1910, Pembrolizumab. Conditions listed: Solid Tumors, Non Small Cell Lung Cancer, Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06205706","url":"https://clinicaltrials.gov/study/NCT06205706"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","hcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["bioinvent-international"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06205706","phase":"1/2","setting":"Phase 1/2a Open-Label, Dose-Escalation, Multicenter, First-in-Human, Consecutive-Cohort, Clinical Trial of BI-1910, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2), as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors","sponsor":"BioInvent International AB","started":"2023-12-04","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06365788","kind":"trial","name":"Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer","aka":["ABBICAR"],"tldr":"A phase 2 trial of abemaciclib and bicalutamide in triple-negative breast cancer, run by Universitaire Ziekenhuizen KU Leuven, now recruiting.","summary":"Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer is a phase 2, interventional study registered as NCT06365788 by Universitaire Ziekenhuizen KU Leuven, with a registry enrolment figure of 53 participants, started 2024-04-08 and due to reach its primary completion in 2027-12. Interventions recorded: Abemaciclib; Bicalutamide. Conditions listed: Triple Negative Breast Neoplasms. Triple-negative eligibility wording from the registry: \"The patient has a biopsy-confirmed diagnosis of recurrent, unresectable, locally advanced, or metastatic AR+ TNBC\". Sites: Belgium. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06365788","url":"https://clinicaltrials.gov/study/NCT06365788"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["abemaciclib","bicalutamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06365788","phase":"2","setting":"A Multicenter Single Arm Phase II Study With Bicalutamide in Combination With Abemaciclib in 4 Cohorts of Locoregionally Advanced Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer","sponsor":"Universitaire Ziekenhuizen KU Leuven","started":"2024-04-08","startedType":"actual","enrolled":53,"enrolledBasis":"registry","outcomes":[]},{"id":"big-lung-trial","kind":"trial","name":"Big Lung Trial","aka":["BLT"],"tldr":"The British trial that asked, without enthusiasm or spin, what chemotherapy is actually worth in lung cancer, and found it worth nine weeks in advanced disease and nothing at all after surgery or radiotherapy.","summary":"The Big Lung Trial was designed to be ordinary: a large pragmatic test, in four separate primary-treatment settings, of the conclusion of the 1995 non-small-cell lung cancer meta-analysis. In the supportive care setting it randomised 725 people and found that chemotherapy improved survival with a hazard ratio of 0.77 (95 percent confidence interval 0.66 to 0.89, p = 0.0006), a median gain from 5.7 to 8.0 months, or nine weeks. There were 19 treatment-related deaths (5 percent), no significant differences on the pre-defined quality-of-life endpoints, and the regimens were cost-effective because the extra cost was offset by longer survival.\n\nIn the surgical setting it randomised 381 people and found no overall survival benefit (hazard ratio 1.02, 0.77 to 1.35, p = 0.90). In the radical radiotherapy setting it randomised 288 and found none either (hazard ratio 1.07, 0.84 to 1.38), closing early for slow accrual. The trial also produced one of the most useful pieces of honesty in British trial history: of 688 newly diagnosed patients at two London centres, only 63 (9.2 percent) entered, and of the 253 who were potentially eligible, 186 (73.5 percent) refused.","status":"mixed","asOf":"2026-09-25","links":[{"label":"Thorax 2004 (supportive care setting)","url":"https://europepmc.org/article/MED/15454647"},{"label":"European Journal of Cardio-Thoracic Surgery 2004 (surgical setting)","url":"https://europepmc.org/article/MED/15200998"},{"label":"Thorax 2000 (recruitment)","url":"https://europepmc.org/article/MED/10817793"}],"tags":["uk","lung","pragmatic-trial"],"related":[],"cancers":["nsclc","lung-cancer"],"sections":["chemotherapy"],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Cisplatin-based chemotherapy added to supportive care, to surgery or to radical radiotherapy in non-small-cell lung cancer: a deliberately plain, large pragmatic trial testing whether the 1995 meta-analysis was right","sponsor":"Medical Research Council and the British Thoracic Oncology Group","result":"In advanced disease, chemotherapy gave a hazard ratio for death of 0.77 and a median gain of nine weeks; in the surgical and radical radiotherapy settings there was no survival benefit.","yearReported":2004,"enrolled":1394,"enrolledBasis":"randomised","enrolledNote":"The trial randomised in four settings and reported separately: 725 in the supportive care comparison, 381 in the surgical comparison and 288 in the radical radiotherapy comparison.","outcomes":[]},{"id":"bilcap","kind":"trial","name":"BILCAP","aka":[],"tldr":"Six months of oral chemotherapy after surgery became the standard for bile duct cancer despite a technically negative primary result.","summary":"BILCAP, registered as ISRCTN72785446 and sponsored by Cancer Research UK, reported in 2017 and published in Lancet Oncology in 2019, made six months of oral capecitabine after surgery the standard for bile duct cancer despite a technically negative primary result. It randomised 447 patients to capecitabine or observation after resection, and the intention-to-treat overall survival analysis missed statistical significance while the per-protocol analysis was significant, after which ASCO and ESMO guidelines adopted it as standard adjuvant therapy. OnCo links it to biliary tract and gallbladder cancer, cytotoxic chemotherapy and Cancer Research UK. Whether a per-protocol result should set a standard of care, and whether adding immunotherapy or gemcitabine to adjuvant capecitabine improves on it, are the open questions.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ISRCTN registry entry (ISRCTN72785446)","url":"https://www.isrctn.com/ISRCTN72785446"},{"label":"Primrose et al., Lancet Oncology 2019","url":"https://doi.org/10.1016/S1470-2045(18)30915-X"},{"label":"ISRCTN72785446","url":"https://www.isrctn.com/ISRCTN72785446"},{"label":"ClinicalTrials.gov NCT00363584","url":"https://clinicaltrials.gov/study/NCT00363584"},{"label":"Bridgewater et al., JCO 2022: long-term outcomes of BILCAP","url":"https://doi.org/10.1200/JCO.21.02568"}],"tags":["lesson:itt-vs-per-protocol"],"related":[],"cancers":["cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","gallbladder","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":[],"companies":[],"institutions":["cruk"],"pathways":[],"terms":[],"trials":[],"people":["john-primrose"],"bottlenecks":[],"keyPapers":["paper-mcclements-capbil-surgical-outcomes-gallbladder-cancer-hpb-2026","paper-mcclements-capbil-incidental-gallbladder-cancer-bjs-2026"],"journals":[],"dependsOn":[],"notes":["Gallbladder cancer: BILCAP enrolled histologically confirmed cholangiocarcinoma or muscle-invasive gallbladder cancer after macroscopically complete resection at 44 UK hepatopancreatobiliary centres, so its result is the adjuvant evidence for gallbladder cancer from T1b upward. Registered as ISRCTN72785446, NCT00363584 and EudraCT 2005-003318-13; funded by Cancer Research UK and Roche. The long-term analysis (2022, median follow-up 106 months) kept the intention-to-treat hazard ratio at 0.84 (0.67 to 1.06) and the adjusted sensitivity analysis at 0.74 (0.59 to 0.94)."],"nct":"ISRCTN72785446","phase":"3","setting":"Adjuvant capecitabine for 6 months vs observation after resection of biliary tract cancer","sponsor":"Cancer Research UK","result":"OS 51.1 vs 36.4 months; ITT HR 0.81 (p=0.097), per-protocol HR 0.75.","yearReported":2017,"enrolled":447,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (ITT)","primary":true,"unit":"months","arms":[{"name":"Capecitabine","n":223,"value":51.1},{"name":"Observation","n":224,"value":36.4}],"hr":0.81,"ci":[0.63,1.04],"p":"0.097","source":"https://doi.org/10.1016/S1470-2045(18)30915-X"},{"endpoint":"Overall survival (per protocol)","unit":"months","arms":[{"name":"Capecitabine","n":210,"value":53},{"name":"Observation","n":220,"value":36}],"hr":0.75,"ci":[0.58,0.97],"p":"0.028","source":"https://doi.org/10.1016/S1470-2045(18)30915-X"},{"endpoint":"Overall survival (ITT, sensitivity analysis adjusted for minimisation factors, nodal status, grade and sex)","unit":"months","arms":[{"name":"Capecitabine","n":223,"value":51.1},{"name":"Observation","n":224,"value":36.4}],"hr":0.71,"ci":[0.55,0.92],"p":"0.010","source":"https://doi.org/10.1016/S1470-2045(18)30915-X"},{"endpoint":"Recurrence-free survival (ITT)","unit":"months","arms":[{"name":"Capecitabine","n":223,"value":24.4},{"name":"Observation","n":224,"value":17.5}],"source":"https://doi.org/10.1016/S1470-2045(18)30915-X"},{"endpoint":"Overall survival (ITT, long-term analysis, median follow-up 106 months)","unit":"months","arms":[{"name":"Capecitabine","n":223,"value":49.6},{"name":"Observation","n":224,"value":36.1}],"hr":0.84,"ci":[0.67,1.06],"source":"https://doi.org/10.1200/JCO.21.02568"},{"endpoint":"Grade 3 toxicity, capecitabine arm (at least one event)","unit":"%","arms":[{"name":"Capecitabine (213 treated)","n":213,"value":44,"note":"Hand-foot syndrome 20%, diarrhoea 8%, fatigue 8%"}],"source":"https://doi.org/10.1016/S1470-2045(18)30915-X"}]},{"id":"nct00513539","kind":"trial","name":"Biliary Stenting With or Without Photodynamic Therapy in Treating Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors That Cannot Be Removed by Surgery","aka":["Photostent-02"],"tldr":"A phase 3 trial of Porfimer sodium in Biliary tract cancer and Gallbladder cancer, run by University College, London, completed.","summary":"Biliary Stenting With or Without Photodynamic Therapy in Treating Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors That Cannot Be Removed by Surgery is a phase 3 interventional study registered as NCT00513539 by University College, London, with 92 participants recorded, started 2007-07 and reaching its primary completion in 2009-12. Interventions recorded: porfimer sodium, biliary stenting. Conditions recorded: Extrahepatic Bile Duct Cancer, Gallbladder Cancer.\n\nLinked to the drug Porfimer sodium because the registry names it among its interventions and Biliary tract cancer and Gallbladder cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00513539","url":"https://clinicaltrials.gov/study/NCT00513539"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma","gallbladder"],"sections":[],"technologies":[],"targets":[],"drugs":["porfimer-sodium"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00513539","phase":"3","setting":"Porfimer Sodium Photodynamic Therapy Plus Stenting Versus Stenting Alone in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumours: a Multicentre, Randomised, Phase Lll Study","sponsor":"University College, London","started":"2007-07","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06159478","kind":"trial","name":"Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)","aka":["Perfume"],"tldr":"A phase 2 trial in pancreatic cancer, run by National Cancer Center, Japan, now recruiting.","summary":"Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume) is a phase 2, interventional study registered as NCT06159478 by National Cancer Center, Japan, with a registry enrolment figure of 32 participants, started 2023-03-29 and due to reach its primary completion in 2027-02-28. Interventions recorded: Binimetinib 15 MG. Conditions listed: Low-grade Glioma; Pancreatic Cancer. Primary outcome: Overall response rate (centrally assessed). Pancreatic eligibility wording from the registry: \"Cohort B 19) Histopathologically diagnosed as pancreatic cancer (histologically not specified)\". Sites: Japan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06159478","url":"https://clinicaltrials.gov/study/NCT06159478"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic","kras-wild-type-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06159478","phase":"2","setting":"Phase II Investigator-initiated Trial of Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)","sponsor":"National Cancer Center, Japan","started":"2023-03-29","startedType":"actual","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03444844","kind":"trial","name":"Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer","aka":[],"tldr":"A phase 1/2 trial of Ga-68 P16-093 PET/CT scan in prostate cancer, run by Five Eleven Pharma, Inc., active and no longer recruiting.","summary":"Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer is a phase 1/2 interventional study registered as NCT03444844 by Five Eleven Pharma, Inc., with 60 participants enrolled, started 2018-05-10 and due to reach its primary completion in 2020-10-27. Interventions recorded: Ga-68 P16-093 PET/CT scan.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03444844","url":"https://clinicaltrials.gov/study/NCT03444844"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-bcr"],"sections":[],"technologies":["pet","pet-ct"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03444844","phase":"1/2","setting":"Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer Patients With Intermediate/High Risk Primary Disease or Biochemical Recurrence After Treatment","sponsor":"Five Eleven Pharma, Inc.","started":"2018-05-10","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06062810","kind":"trial","name":"Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms","aka":["Drugs-SNPs"],"tldr":"A phase 2/3 trial of Raloxifene in advanced solid tumours, run by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, active and no longer recruiting.","summary":"Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms is a phase 2/3 interventional study registered as NCT06062810 by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, with 600 participants enrolled, started 2025-06-21 and due to reach its primary completion in 2026-12-18. Interventions recorded: Raloxifene - Usual and Raloxifene - Study.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06062810","url":"https://clinicaltrials.gov/study/NCT06062810"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["raloxifene"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06062810","phase":"2/3","setting":"Explore the Relationship Between Single Nucleotide Polymorphisms and Raloxifene Response and Toxicity in Patients With Breast Cancer LCIS","sponsor":"Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair","started":"2025-06-21","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06530303","kind":"trial","name":"Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer","aka":["BAH248"],"tldr":"A phase 1/2 trial of cyclophosphamide, fludarabine, aldesleukin (high-dose IL-2) and pembrolizumab in colorectal cancer, run by Essen Biotech, now recruiting.","summary":"Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer is a phase 1/2, interventional study registered as NCT06530303 by Essen Biotech, with a registry enrolment figure of 85 participants, started 2024-09-29 and due to reach its primary completion in 2026-09-10. Interventions recorded: Tumor Infiltrating Lymphocytes (TIL); Cyclophosphamide; Fludarabine; Interleukin-2; Pembrolizumab. Conditions listed: Colorectal Cancer; Colon Cancer; Rectum Cancer. Primary outcome: Adverse Events. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06530303","url":"https://clinicaltrials.gov/study/NCT06530303"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["cyclophosphamide","fludarabine","aldesleukin","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06530303","phase":"1/2","setting":"Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Immunotherapy in Patients With Advanced or Metastatic Refractory Colon and Rectal Cancer (Colorectum)","sponsor":"Essen Biotech","started":"2024-09-29","startedType":"actual","enrolled":85,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07410494","kind":"trial","name":"Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors","aka":["SELECT-CAR-NK"],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Essen Biotech, now recruiting.","summary":"Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors is a phase 1/2, interventional study registered as NCT07410494 by Essen Biotech, with a registry enrolment figure of 85 participants, started 2026-02-01 and due to reach its primary completion in 2027-12-28. Interventions recorded: EB-SELECT Single-Target CAR-NK Cells; Dual-Target Antigen-Selected CAR-NK. Conditions listed: Cancer; Breast Cancer; Non-Small Cell Lung Cancer (NSCLC); Colorectal Cancer (Locally Advanced or Metastatic); Prostate Cancer - Recurrent; Pancreatic Ductal Adenocarcinoma (PDAC); Ovarian Cancer; Glioblastoma; Melanoma (Skin Cancer); Acute Myeloid Leukemia (AML); Non Hodgkin Lymphoma; Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma; Liver Cancer. Primary outcome: Incidence, type, and severity of adverse events (AEs), graded by CTCAE v5.0; Incidence of Dose-Limiting Toxicities (DLTs). Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07410494","url":"https://clinicaltrials.gov/study/NCT07410494"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07410494","phase":"1/2","setting":"A Phase 1/2, Open-Label, Biomarker-Driven Study of Allogeneic Donor-Derived CAR-NK Cells With Antigen Selection by Tissue Biopsy and/or Liquid Biopsy Profiling in Participants With Relapsed/Refractory Advanced Solid Tumors (Single-Target vs Dual-Target Strategy)","sponsor":"Essen Biotech","started":"2026-02-01","startedType":"actual","enrolled":85,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07523529","kind":"trial","name":"Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors","aka":["SELECT-2CAR"],"tldr":"A phase 1/2 trial of Fludarabine and Cyclophosphamide in advanced solid tumours, run by Beijing Biotech, now recruiting.","summary":"Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07523529 by Beijing Biotech, with 72 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-04-14. Interventions recorded: Autologous dual-target CAR-T cells selected from the predefined target library., Fludarabine and Cyclophosphamide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07523529","url":"https://clinicaltrials.gov/study/NCT07523529"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["fludarabine","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07523529","phase":"1/2","setting":"A Phase 1/2, Open-Label, Biomarker-Guided Master Protocol Evaluating Autologous Dual-Target CAR-T Cells Selected From a Predefined Target Library in Adults With Advanced Solid Tumors","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"bl-b01d1-307","kind":"trial","name":"BL-B01D1-307","aka":[],"tldr":"The first phase 3 win for a bispecific ADC, in triple-negative breast cancer, announced February 2026.","summary":"BL-B01D1-307, trial NCT06382142 sponsored by SystImmune and Bristol Myers Squibb and announced on 26 February 2026, delivered the first phase 3 win for a bispecific antibody-drug conjugate, izalontamab brengitecan, in previously treated locally advanced or metastatic triple-negative breast cancer. It randomised 418 patients in China to the EGFR by HER3 conjugate or chemotherapy and met its primary progression-free survival endpoint by blinded review and its interim overall survival endpoint with statistically significant and clinically meaningful improvements, with full data at ASCO 2026 and a parallel positive phase 3 in oesophageal squamous cell carcinoma. It has not been replicated outside China, and the global first-line IZABRIGHT-Breast01 trial will show whether the result travels, which is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT06382142","url":"https://clinicaltrials.gov/study/NCT06382142"},{"label":"Targeted Oncology report","url":"https://www.targetedonc.com/view/iza-bren-meets-pfs-and-os-end-points-in-phase-3-tnbc-trial"}],"tags":[],"related":["src-targeted-oncology"],"cancers":["tnbc"],"sections":[],"technologies":["bispecific-adc"],"targets":[],"drugs":["izalontamab-brengitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06382142","phase":"3","setting":"Previously treated locally advanced or metastatic TNBC: izalontamab brengitecan vs chemotherapy","sponsor":"SystImmune / BMS","result":"PFS and OS significantly improved at interim analysis (numbers presented ASCO 2026).","started":"2024-06-21","startedType":"actual","yearReported":2026,"enrolled":418,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Izalontamab brengitecan","n":207,"value":8.5},{"name":"Chemotherapy (TPC)","n":211,"value":3.1}],"hr":0.29,"ci":[0.22,0.38],"p":"<0.0001","source":"https://www.onclive.com/view/iza-bren-yields-pfs-and-os-benefits-vs-chemo-in-previously-treated-advanced-tnbc"},{"endpoint":"Overall survival (interim, median follow-up 11 months)","primary":true,"unit":"months","arms":[{"name":"Izalontamab brengitecan","value":15.9},{"name":"Chemotherapy (TPC)","value":12.5}],"hr":0.6,"ci":[0.42,0.85],"p":"0.0019","source":"https://www.onclive.com/view/iza-bren-yields-pfs-and-os-benefits-vs-chemo-in-previously-treated-advanced-tnbc"},{"endpoint":"Confirmed objective response rate (BICR)","unit":"%","arms":[{"name":"Izalontamab brengitecan","value":51.7},{"name":"Chemotherapy (TPC)","value":20.5}]}],"replication":"Single Chinese phase 3 with an interim OS analysis; a parallel positive phase 3 in oesophageal squamous cell carcinoma supports the drug, and the global IZABRIGHT-Breast01 trial will test the first-line setting. Not yet replicated outside China."},{"id":"nct07625644","kind":"trial","name":"BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)","aka":["BrenDeLL-Lung01"],"tldr":"A phase 3 trial of Atezolizumab, Carboplatin, Etoposide in small-cell lung cancer, run by SystImmune Inc., now recruiting.","summary":"BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01) is a phase 3 interventional study registered as NCT07625644 by SystImmune Inc., with 550 participants planned, started 2026-08-04 and due to reach its primary completion in 2030-01. Interventions recorded: BL-M14D1 and Atezolizumab, Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin. Conditions listed: Small Cell Lung Cancer Extensive Stage, Small-cell Lung Cancer, Small Cell Carcinoma, Sclc. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07625644","url":"https://clinicaltrials.gov/study/NCT07625644"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab","carboplatin","etoposide","lurbinectedin"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07625644","phase":"3","setting":"A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients With First-Line Extensive-Stage Small Cell Lung Cancer","sponsor":"SystImmune Inc.","started":"2026-08-04","startedType":"actual","enrolled":550,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00002872","kind":"trial","name":"Bleomycin, Doxycycline, or Talc in Treating Patients With Malignant Pleural Effusions","aka":[],"tldr":"A phase 3 trial of Bleomycin and Talc in Metastatic cancer, run by Eastern Cooperative Oncology Group, completed.","summary":"Bleomycin, Doxycycline, or Talc in Treating Patients With Malignant Pleural Effusions is a phase 3 interventional study registered as NCT00002872 by Eastern Cooperative Oncology Group, with 480 participants recorded, started 1997-01-10 and reaching its primary completion in 2003-02. Interventions recorded: bleomycin sulfate, doxycycline, talc. Conditions recorded: Metastatic Cancer.\n\nLinked to the drug Talc because the registry names it among its interventions and Metastatic cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00002872","url":"https://clinicaltrials.gov/study/NCT00002872"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["bleomycin","talc-sclerosant"],"companies":["ecog-acrin"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002872","phase":"3","setting":"A PROSPECTIVE RANDOMIZED TRIAL OF BLEOMYCIN VS. DOXYCYCLINE VS. TALC FOR THE INTRAPLEURAL TREATMENT OF MALIGNANT PLEURAL EFFUSIONS","sponsor":"Eastern Cooperative Oncology Group","started":"1997-01-10","startedType":"actual","enrolled":480,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07610525","kind":"trial","name":"Blood and imagE-guided Optimization of Neoadjuvant Therapy in People With Early Stage Triple-negative Breast cancER - the BETTER Trial","aka":[],"tldr":"A phase 2 trial of paclitaxel / nab-paclitaxel, carboplatin and pembrolizumab in triple-negative breast cancer, run by M.D. Anderson Cancer Center, not yet recruiting.","summary":"Blood and imagE-guided Optimization of Neoadjuvant Therapy in People With Early Stage Triple-negative Breast cancER - the BETTER Trial is a phase 2, interventional study registered as NCT07610525 by M.D. Anderson Cancer Center, with a registry enrolment figure of 200 participants, started 2026-11-05 and due to reach its primary completion in 2029-01-15. Interventions recorded: Paclitaxel + Carboplatin; Pembrolizumab. Conditions listed: Triple Negative Breast Cancer; Blood and Image Guided; Optimization of Neoadjuvant Therapy; Phase 2. Triple-negative eligibility wording from the registry: \"* Histologically proven TNBC, defined as ER ≤10%, PR ≤10%, and HER2 negative based on the 2023 ASCO/CAP guidelines\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07610525","url":"https://clinicaltrials.gov/study/NCT07610525"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["paclitaxel","carboplatin","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07610525","phase":"2","setting":"Blood and imagE-guided Optimization of Neoadjuvant Therapy in People With Early Stage Triple-negative Breast cancER - the BETTER Tria","sponsor":"M.D. Anderson Cancer Center","started":"2026-11-05","startedType":"estimated","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05630209","kind":"trial","name":"Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG)","aka":[],"tldr":"A phase 1/2 trial of Doxorubicin in brain and spinal cord tumours, run by InSightec, active and no longer recruiting.","summary":"Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG) is a phase 1/2 interventional study registered as NCT05630209 by InSightec, with 10 participants enrolled, started 2023-01-04 and due to reach its primary completion in 2026-06. Interventions recorded: Exablate and Doxorubicin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05630209","url":"https://clinicaltrials.gov/study/NCT05630209"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["brain-tumours","glioblastoma","dipg-dmg"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["doxorubicin"],"companies":["insightec"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05630209","phase":"1/2","setting":"A Safety and Feasibility Study to Evaluate Blood Brain Barrier Disruption Using Exablate MR Guided Focused Ultrasound in Combination With Doxorubicin in Treating Pediatric Patients With Diffuse Intrinsic Pontine Gliomas (DIPG)","sponsor":"InSightec","started":"2023-01-04","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05615623","kind":"trial","name":"Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG","aka":[],"tldr":"A phase 1/2 trial of Doxorubicin in brain and spinal cord tumours, run by InSightec, active and no longer recruiting.","summary":"Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG is a phase 1/2 interventional study registered as NCT05615623 by InSightec, with 10 participants enrolled, started 2023-01-04 and due to reach its primary completion in 2026-06. Interventions recorded: Exablate and Doxorubicin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05615623","url":"https://clinicaltrials.gov/study/NCT05615623"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["brain-tumours","glioblastoma","dipg-dmg"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["doxorubicin"],"companies":["insightec"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05615623","phase":"1/2","setting":"A Safety and Feasibility Study to Evaluate Blood Brain Barrier Disruption Using Exablate MR Guided Focused Ultrasound in Combination With Doxorubicin in Treating Pediatric Patients With Diffuse Intrinsic Pontine Gliomas (DIPG)","sponsor":"InSightec","started":"2023-01-04","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05317858","kind":"trial","name":"Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets","aka":["LIMITLESS"],"tldr":"A phase 3 trial of Pembrolizumab, Atezolizumab, Cemiplimab in non-small-cell lung cancer and small-cell lung cancer, run by InSightec, now recruiting.","summary":"Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets is a phase 3 interventional study registered as NCT05317858 by InSightec, with 30 participants planned, started 2022-08-12 and due to reach its primary completion in 2027-06-01. Interventions recorded: Blood Brain Barrier Opening - Oncology, Pembrolizumab, Atezolizumab, Cemiplimab, Nivolumab. Conditions listed: Brain Tumor, Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05317858","url":"https://clinicaltrials.gov/study/NCT05317858"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","atezolizumab","cemiplimab","nivolumab"],"companies":["insightec"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05317858","phase":"3","setting":"A Randomized Pivotal Study Assessing the Safety and Efficacy of Targeted Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin","sponsor":"InSightec","started":"2022-08-12","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"blue-c","kind":"trial","name":"BLUE-C","aka":[],"tldr":"The study behind Cologuard Plus: the new stool test caught 94% of bowel cancers and produced fewer false alarms than the original.","summary":"Among 20,176 participants with colonoscopy as the reference (NEJM 2024), sensitivity for colorectal cancer was 93.9% for the next-generation test versus 67.3% for FIT, sensitivity for advanced precancerous lesions 43.4% versus 23.3%, and specificity for advanced neoplasia 90.6% versus 94.8%. Specificity was higher than in the original DeeP-C study, which translates into fewer unnecessary colonoscopies per cancer found.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT04144738","url":"https://clinicaltrials.gov/study/NCT04144738"},{"label":"BLUE-C (NEJM 2024)","url":"https://doi.org/10.1056/NEJMoa2310336"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["colorectal-screening","methylation-profiling"],"targets":[],"drugs":["cologuard-plus"],"companies":["exact-sciences"],"institutions":[],"pathways":[],"terms":["fit-test","sensitivity-specificity"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-blue-c-n-engl-j-med-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04144738","phase":"observational","setting":"Prospective cross-sectional study of the next-generation multitarget stool DNA test (Cologuard Plus) and FIT against screening colonoscopy in average-risk adults aged 40 and over","sponsor":"Exact Sciences","result":"Sensitivity 93.9% for colorectal cancer (FIT 67.3%); specificity 90.6% for advanced neoplasia.","started":"2019-11-15","startedType":"actual","yearReported":2024,"enrolled":20176,"enrolledBasis":"registry","outcomes":[{"endpoint":"Sensitivity for colorectal cancer","primary":true,"unit":"%","arms":[{"name":"Next-generation mt-sDNA (Cologuard Plus)","value":93.9},{"name":"FIT","value":67.3}],"source":"https://doi.org/10.1056/NEJMoa2310336"},{"endpoint":"Specificity for advanced neoplasia","primary":true,"unit":"%","arms":[{"name":"Next-generation mt-sDNA (Cologuard Plus)","value":90.6},{"name":"FIT","value":94.8}],"source":"https://doi.org/10.1056/NEJMoa2310336"}]},{"id":"nct07226856","kind":"trial","name":"BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-paclitaxel for the Treatment of Metastatic and Recurrent Pancreatic Adenocarcinoma","aka":[],"tldr":"A phase 2 trial of gemcitabine, nab-paclitaxel and nivolumab in pancreatic cancer, run by Mayo Clinic, now recruiting.","summary":"BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-paclitaxel for the Treatment of Metastatic and Recurrent Pancreatic Adenocarcinoma is a phase 2, interventional study registered as NCT07226856 by Mayo Clinic, with a registry enrolment figure of 43 participants, started 2025-12-12 and due to reach its primary completion in 2028-12-01. Interventions recorded: Biopsy Procedure; Biospecimen Collection; Computed Tomography; Gemcitabine; Imzokitug; Magnetic Resonance Imaging; Nab-paclitaxel; Nivolumab. Conditions listed: Metastatic Pancreatic Adenocarcinoma; Recurrent Pancreatic Adenocarcinoma; Stage IV Pancreatic Cancer AJCC v8. Primary outcome: Incidence of significant adverse events (AEs) (Safety Run-in); Objective response rate (Phase II). Pancreatic eligibility wording from the registry: \"* Histological confirmation of pancreatic adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07226856","url":"https://clinicaltrials.gov/study/NCT07226856"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","nab-paclitaxel","nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07226856","phase":"2","setting":"Phase 2, Single-Arm Trial of BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-Paclitaxel in the First Line Setting of Advanced Pancreatic Adenocarcinoma","sponsor":"Mayo Clinic","started":"2025-12-12","startedType":"actual","enrolled":43,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07594626","kind":"trial","name":"BMS-986504 in Combination With Pemetrexed for the Treatment of Metastatic Solid Tumors With MTAP Deletion","aka":[],"tldr":"A phase 1/2 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by Northwestern University, now recruiting.","summary":"BMS-986504 in Combination With Pemetrexed for the Treatment of Metastatic Solid Tumors With MTAP Deletion is a phase 1/2 interventional study registered as NCT07594626 by Northwestern University, with a registry enrolment figure of 72 participants, started 2026-08-21 and due to reach its primary completion in 2030-12-09. Interventions recorded: Biospecimen Collection, Computed Tomography, Pemetrexed, PRMT5 Inhibitor BMS-986504. Conditions listed: Metastatic Biliary Tract Carcinoma, Metastatic Colon Carcinoma, Metastatic Esophageal Carcinoma, Metastatic Malignant Digestive System Neoplasm, Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Carcinoma, Stage IV Colon Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07594626","url":"https://clinicaltrials.gov/study/NCT07594626"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07594626","phase":"1/2","setting":"A Phase Ib/II Basket Study of BMS-986504 in Combination With Pemetrexed for Metastatic Solid Tumors With MTAP Deletion","sponsor":"Northwestern University","started":"2026-08-21","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"bmt-ctn-0803","kind":"trial","name":"BMT CTN 0803","aka":["BMTCTN0803","CTN 0803","AMC 071"],"tldr":"BMT CTN 0803 showed that people living with HIV whose lymphoma had come back can have the same high-dose chemotherapy and stem cell transplant as anyone else, with 87 percent alive at one year and outcomes no different from matched HIV-negative patients, so HIV alone should not bar transplant.","summary":"BMT CTN 0803/AMC 071 was a single-arm phase 2 trial of the Blood and Marrow Transplant Clinical Trials Network and the AIDS Malignancy Consortium in 43 HIV-infected patients with chemotherapy-sensitive relapsed or persistent aggressive B-cell or Hodgkin lymphoma; 40 underwent autologous transplant after BEAM conditioning with protocol-defined management of antiretroviral therapy around transplant. The primary endpoint was one-year overall survival.\n\nAt a median follow-up of 24.8 months, one- and two-year overall survival were 87.3 and 82 percent, two-year progression-free survival 79.8 percent and one-year transplant-related mortality 5.2 percent; engraftment was prompt and outcomes did not differ from 151 matched HIV-negative registry controls. The corpus's HIV-associated lymphoma page cites BMT CTN 0803 for autologous transplant being feasible with controlled HIV.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01141712","url":"https://clinicaltrials.gov/study/NCT01141712"}],"tags":["soc-trials"],"related":[],"cancers":["hiv-associated-lymphoma","non-hodgkin-lymphoma","hodgkin-lymphoma"],"sections":[],"technologies":["autologous-stem-cell-transplant","cytotoxic-chemotherapy"],"targets":[],"drugs":["carmustine","etoposide","cytarabine","melphalan"],"companies":[],"institutions":["mcw-cancer-center"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-bmt-ctn-0803-autologous-transplant-hiv-lymphoma-alvarnas-blood-2016"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01141712","phase":"2","setting":"HIV-infected patients over 15 with chemotherapy-sensitive relapsed or persistent aggressive B-cell lymphoma or Hodgkin lymphoma and treatable HIV: high-dose carmustine, etoposide, cytarabine and melphalan (BEAM) with autologous stem cell transplant and consistent peri-transplant antiretroviral management","sponsor":"Medical College of Wisconsin","result":"One-year overall survival 87.3 percent and two-year overall survival 82 percent after autologous transplant, with two-year progression-free survival 79.8 percent and one-year transplant-related mortality 5.2 percent, no different from matched HIV-negative controls.","started":"2010-04","yearReported":2016,"enrolled":43,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 1 year","primary":true,"unit":"%","arms":[{"name":"BEAM and autologous transplant in HIV-infected patients","n":40,"value":87.3,"note":"95% CI 72.1 to 94.5; 43 enrolled, 40 transplanted"}],"source":"https://doi.org/10.1182/blood-2015-08-664706"},{"endpoint":"Overall survival at 2 years","unit":"%","arms":[{"name":"BEAM and autologous transplant in HIV-infected patients","n":40,"value":82,"note":"95% CI 65.9 to 91"}],"source":"https://doi.org/10.1182/blood-2015-08-664706"},{"endpoint":"Progression-free survival at 2 years","unit":"%","arms":[{"name":"BEAM and autologous transplant in HIV-infected patients","n":40,"value":79.8,"note":"95% CI 63.7 to 89.4"}],"source":"https://doi.org/10.1182/blood-2015-08-664706"},{"endpoint":"Transplant-related mortality at 1 year","unit":"%","arms":[{"name":"BEAM and autologous transplant in HIV-infected patients","n":40,"value":5.2}],"source":"https://doi.org/10.1182/blood-2015-08-664706"}]},{"id":"bmt-ctn-1102","kind":"trial","name":"BMT CTN 1102","aka":["BMTCTN1102","CTN 1102"],"tldr":"BMT CTN 1102 settled whether older people with higher-risk myelodysplastic syndrome should be offered a stem-cell transplant: those who had a matched donor and went to transplant were far more likely to be alive three years later than those without a donor who had drug treatment instead, so transplant belongs in the plan for fit patients aged 50 to 75.","summary":"BMT CTN 1102 was a multicentre biologic assignment trial of the Blood and Marrow Transplant Clinical Trials Network in 384 patients aged 50 to 75 with intermediate-2 or high-risk de novo myelodysplastic syndrome enrolled at 34 centres between 2014 and 2018. Patients were assigned to the donor arm (reduced-intensity allogeneic transplant) or the no-donor arm (hypomethylating therapy or best supportive care) according to whether a matched donor was found within 90 days of registration. The primary endpoint was overall survival at three years by intention to treat.\n\nAdjusted three-year overall survival was 47.9 percent in the donor arm against 26.6 percent in the no-donor arm, an absolute difference of 21.3 percentage points, and leukaemia-free survival was 35.8 against 20.6 percent; the benefit held across every subgroup examined. The trial is the evidence that reduced-intensity transplant should be an integral part of management for fit older adults with higher-risk disease, which is how the corpus's myelodysplastic syndrome page cites it.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02016781","url":"https://clinicaltrials.gov/study/NCT02016781"}],"tags":["soc-trials"],"related":[],"cancers":["mds-higher-risk","mds"],"sections":[],"technologies":["allogeneic-hsct","epigenetic-drugs"],"targets":[],"drugs":["azacitidine"],"companies":[],"institutions":["mcw-cancer-center"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-bmt-ctn-1102-transplant-older-mds-nakamura-jco-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02016781","phase":"2","setting":"Intermediate-2 or high-risk de novo myelodysplastic syndrome in patients aged 50 to 75: assignment by donor availability within 90 days to reduced-intensity allogeneic transplant or to hypomethylating therapy or best supportive care, with three-year overall survival as the primary endpoint","sponsor":"Medical College of Wisconsin","result":"Three-year overall survival 47.9 percent with a donor and reduced-intensity transplant against 26.6 percent without a donor (p 0.0001); leukaemia-free survival 35.8 against 20.6 percent.","started":"2013-12-16","startedType":"actual","yearReported":2021,"enrolled":384,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 3 years (intention to treat, adjusted)","primary":true,"unit":"%","arms":[{"name":"Donor arm: reduced-intensity allogeneic transplant","value":47.9,"note":"95% CI 41.3 to 54.1"},{"name":"No-donor arm: hypomethylating therapy or best supportive care","value":26.6,"note":"95% CI 18.4 to 35.6"}],"p":"0.0001","source":"https://doi.org/10.1200/JCO.20.03380"},{"endpoint":"Leukaemia-free survival at 3 years","unit":"%","arms":[{"name":"Donor arm: reduced-intensity allogeneic transplant","value":35.8,"note":"95% CI 29.8 to 41.8"},{"name":"No-donor arm: hypomethylating therapy or best supportive care","value":20.6,"note":"95% CI 13.3 to 29.1"}],"p":"0.003","source":"https://doi.org/10.1200/JCO.20.03380"}]},{"id":"nct04421820","kind":"trial","name":"BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours","aka":[],"tldr":"A phase 1/2 trial of Leucovorin, FLOT, Fluorouracil in colorectal cancer, run by Bold Therapeutics, Inc., now recruiting.","summary":"BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours is a phase 1/2 interventional study registered as NCT04421820 by Bold Therapeutics, Inc., with 220 participants planned, started 2020-08-28 and due to reach its primary completion in 2026-06-01. Interventions recorded: BOLD-100 +/- FOLFOX Chemotherapy (Arm VII), BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI). Conditions listed: Colorectal Cancer, Pancreatic Cancer, Gastric Cancers, Cholangiocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04421820","url":"https://clinicaltrials.gov/study/NCT04421820"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["leucovorin","flot","fluorouracil","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04421820","phase":"1/2","setting":"A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours","sponsor":"Bold Therapeutics, Inc.","started":"2020-08-28","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"bolero-2","kind":"trial","name":"BOLERO-2","aka":[],"tldr":"BOLERO-2 showed that adding the mTOR inhibitor everolimus to the hormone drug exemestane more than doubled the time that advanced breast cancer stayed under control after aromatase inhibitors had stopped working, the first targeted drug to overcome endocrine resistance.","summary":"BOLERO-2 randomised 724 postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer that had recurred or progressed on letrozole or anastrozole two to one to exemestane plus everolimus or exemestane plus placebo. The primary endpoint was progression-free survival.\n\nEverolimus more than doubled median progression-free survival, at the cost of stomatitis, rash, fatigue, hyperglycaemia and pneumonitis, and overall survival was not significantly different. It was approved in the United States in July 2012 and was the standard second-line option until CDK4/6 inhibitors arrived; it remains an option after CDK4/6 inhibitor progression, particularly in tumours without a PIK3CA mutation.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00863655","url":"https://clinicaltrials.gov/study/NCT00863655"}],"tags":["subtype-trials"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46","breast-cancer"],"sections":[],"technologies":["kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["everolimus","exemestane"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jose-baselga"],"bottlenecks":[],"keyPapers":["paper-bolero-2-n-engl-j-med-2012","paper-bolero-2-ann-oncol-2014-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00863655","phase":"3","setting":"Postmenopausal hormone receptor-positive, HER2-negative advanced breast cancer after a non-steroidal aromatase inhibitor: exemestane with everolimus or placebo","sponsor":"Novartis","result":"Everolimus plus exemestane more than doubled progression-free survival compared with exemestane alone; approved in July 2012.","started":"2009-06-03","startedType":"actual","yearReported":2012,"enrolled":724,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival, local investigator assessment (interim analysis)","primary":true,"unit":"months","arms":[{"name":"Everolimus + exemestane","value":6.9,"note":"Interim analysis after 359 events; 724 randomised 2:1"},{"name":"Placebo + exemestane","value":2.8}],"hr":0.43,"ci":[0.35,0.54],"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1109653"},{"endpoint":"Progression-free survival, central assessment (interim analysis)","unit":"months","arms":[{"name":"Everolimus + exemestane","value":10.6},{"name":"Placebo + exemestane","value":4.1}],"hr":0.36,"ci":[0.27,0.47],"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1109653"},{"endpoint":"Grade 3-4 stomatitis","unit":"%","arms":[{"name":"Everolimus + exemestane","value":8},{"name":"Placebo + exemestane","value":1}],"source":"https://doi.org/10.1056/nejmoa1109653"}]},{"id":"bolt","kind":"trial","name":"BOLT","aka":[],"tldr":"BOLT showed that sonidegib, a second hedgehog pathway pill, shrinks about four in ten locally advanced basal cell carcinomas at its lower dose, and that the higher dose adds side effects rather than responses.","summary":"BOLT randomised 230 patients with locally advanced or metastatic basal cell carcinoma to sonidegib 200 mg or 800 mg daily in a double-blind design with no placebo arm, the question being dose rather than efficacy against a comparator.\n\nAt the 200 mg dose the objective response rate by central review was 43 percent in locally advanced and 15 percent in metastatic disease (Lancet Oncology 2015), with more toxicity and no more responses at 800 mg. Long-term follow-up to 42 months showed durable responses and the same muscle spasm, hair loss and taste disturbance seen with vismodegib.\n\nSonidegib 200 mg was approved for locally advanced basal cell carcinoma in July 2015 and is used interchangeably with vismodegib; neither has been compared with the other head to head.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01327053","url":"https://clinicaltrials.gov/study/NCT01327053"},{"label":"Lancet Oncology 2015","url":"https://doi.org/10.1016/S1470-2045(15)70100-2"}],"tags":[],"related":[],"cancers":["locally-advanced-bcc","basal-cell-carcinoma","skin-cancer"],"sections":[],"technologies":["hedgehog-inhibitors"],"targets":["smoothened"],"drugs":["sonidegib"],"companies":["novartis","sun-pharma"],"institutions":[],"pathways":["hedgehog","basal-cell-carcinoma-signalling"],"terms":["hedgehog-inhibitor-tolerability"],"trials":["stevie","cemiplimab-advanced-bcc","erivance"],"people":["reinhard-dummer"],"bottlenecks":[],"keyPapers":["paper-bolt-sonidegib-migden-lancet-oncol-2015","paper-bolt-j-eur-acad-dermatol-venereol-2018-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01327053","phase":"2","setting":"Locally advanced or metastatic basal cell carcinoma: sonidegib 200 mg versus 800 mg daily","sponsor":"Novartis (now Sun Pharma)","result":"Objective response at 200 mg: 43% in locally advanced and 15% in metastatic basal cell carcinoma (central review).","started":"2011-06-29","startedType":"actual","yearReported":2015,"enrolled":230,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate, 200 mg (locally advanced)","primary":true,"unit":"%","arms":[{"name":"Sonidegib 200 mg","value":43}],"source":"https://doi.org/10.1016/S1470-2045(15)70100-2"}],"replication":"ERIVANCE (vismodegib) found the same response rate for hedgehog inhibition in locally advanced basal cell carcinoma."},{"id":"bond-003","kind":"trial","name":"BOND-003","aka":[],"tldr":"A cancer-killing virus instilled into the bladder produced complete responses in three quarters of patients whose BCG had failed, with almost no serious side effects.","summary":"BOND-003, trial NCT04452591 sponsored by CG Oncology and reported in 2024 with publication in Lancet Oncology in 2025, showed that a cancer-killing virus instilled into the bladder produced complete responses in three quarters of patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer with carcinoma in situ, with almost no serious side effects. In the single-arm cohort C of 110 patients, complete response at any time was 75.2 percent and 41.8 percent at 24 months, with no severe treatment-related events, and a rolling licence application is under way in 2026. OnCo links it to bladder cancer, oncolytic viruses, cretostimogene grenadenorepvec and the BCG-unresponsive term. It is a single-arm registrational study, with the randomised PIVOT-006 and CORE-008 ongoing, so durability against comparators is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04452591","url":"https://clinicaltrials.gov/study/NCT04452591"}],"tags":[],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["oncolytic-virus"],"targets":[],"drugs":["cretostimogene"],"companies":["cg-oncology"],"institutions":[],"pathways":[],"terms":["bcg-unresponsive"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04452591","phase":"3","setting":"BCG-unresponsive high-risk NMIBC with CIS: intravesical cretostimogene grenadenorepvec, single arm (cohort C)","sponsor":"CG Oncology","result":"CR 75.2%; 24-month CR 41.8%.","started":"2020-10-27","startedType":"actual","yearReported":2024,"enrolled":110,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response at any time","primary":true,"unit":"%","arms":[{"name":"Cretostimogene","n":110,"value":75.2}],"source":"https://pubmed.ncbi.nlm.nih.gov/42508433/"},{"endpoint":"Complete response at 24 months","unit":"%","arms":[{"name":"Cretostimogene","value":41.8}],"source":"https://doi.org/10.1016/S1470-2045(26)00194-4"}],"replication":"Single-arm registrational; PIVOT-006 (intermediate-risk, randomised) and CORE-008 (BCG-naive) ongoing."},{"id":"nct07255612","kind":"trial","name":"Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negative Breast Cancer)","aka":[],"tldr":"A phase 2 trial of trilaciclib and eribulin in triple-negative breast cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negative Breast Cancer) is a phase 2, interventional study registered as NCT07255612 by Sun Yat-sen University, with a registry enrolment figure of 29 participants, started 2026-11-04 and due to reach its primary completion in 2026-12-01. Interventions recorded: Trilaciclib; Eribulin. Conditions listed: Breast Cancer. Triple-negative eligibility wording from the registry: \"locally advanced or metastatic triple-negative breast cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07255612","url":"https://clinicaltrials.gov/study/NCT07255612"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["trilaciclib","eribulin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07255612","phase":"2","setting":"A Single-arm, Phase II Study for Bone Marrow Protection, Safety, and Efficacy of Trilaciclib Combined With Eribulin in Locally Advanced or Metastatic Triple-negative Breast Cancer After at Least Two Prior Chemotherapy Regimens","sponsor":"Sun Yat-sen University","started":"2026-11-04","startedType":"estimated","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"bonner-cetuximab-rt","kind":"trial","name":"Bonner trial (cetuximab plus radiotherapy)","aka":[],"tldr":"The Bonner trial was the first to show that a targeted antibody improves survival when added to radiotherapy: cetuximab with radiotherapy lengthened survival in head and neck cancer, and became the option for patients who cannot have cisplatin.","summary":"Bonner and colleagues randomised 424 patients with stage III or IV squamous cell carcinoma of the oropharynx, hypopharynx or larynx to high-dose radiotherapy alone or with weekly cetuximab. Median overall survival was 49.0 months with cetuximab versus 29.3 months (hazard ratio 0.74), and locoregional control improved, with an acneiform rash but no increase in mucositis (New England Journal of Medicine 2006). Later trials (RTOG 1016, De-ESCALaTE) showed cetuximab is inferior to cisplatin in HPV-positive disease, so its role is in cisplatin-unfit patients.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00004227","url":"https://clinicaltrials.gov/study/NCT00004227"},{"label":"NEJM 2006","url":"https://doi.org/10.1056/NEJMoa053422"}],"tags":["radiation-wave4"],"related":[],"cancers":["head-and-neck","oropharyngeal-cancer","laryngeal-cancer","hypopharyngeal-cancer"],"sections":[],"technologies":["imrt-igrt","radiosensitisers"],"targets":[],"drugs":["cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00004227","phase":"3","setting":"Locoregionally advanced head and neck squamous cell carcinoma: radiotherapy with or without cetuximab","sponsor":"ImClone Systems","result":"Median overall survival 49.0 vs 29.3 months (hazard ratio 0.74).","started":"1999-04","yearReported":2006,"enrolled":424,"enrolledBasis":"registry","outcomes":[{"endpoint":"Locoregional control (primary) and overall survival","primary":true,"unit":"months","arms":[{"name":"Radiotherapy plus cetuximab","n":211,"value":49},{"name":"Radiotherapy alone","n":213,"value":29.3}]}]},{"id":"nct07485452","kind":"trial","name":"Boosting Osimertinib Blood Brain Barrier Penetration","aka":["OSIBBBOOST"],"tldr":"A phase 2 trial in lung cancer, run by Maastricht University Medical Center, now recruiting.","summary":"Boosting Osimertinib Blood Brain Barrier Penetration is a phase 2, interventional study registered as NCT07485452 by Maastricht University Medical Center, with a registry enrolment figure of 7 participants, started 2026-06 and due to reach its primary completion in 2027-06. Interventions recorded: Osimertinib & febuxostat. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Effect of combining osimertinib with febuxostat on osimertinib CSF:plasma ratio in patients with EGFR NSCLC without CNS metastases. Lung eligibility wording from the registry: \"The patient has metastatic EGFR-mutated NSCLC and is treated with osimertinib as part of regular care with CT-confirmed stable disease or better\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07485452","url":"https://clinicaltrials.gov/study/NCT07485452"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07485452","phase":"2","setting":"Boosting Osimertinib Blood Brain Barrier Penetration in Patients With Epidermal Growth Factor Receptor Mutated Non-small Cell Lung Cancer","sponsor":"Maastricht University Medical Center","started":"2026-06","startedType":"estimated","enrolled":7,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06709144","kind":"trial","name":"Borderline of CME/D3 Dissection for Local Advanced Right-sided Colon Cancer","aka":["BLARCC"],"tldr":"A phase 3 trial in colorectal cancer, run by Haixing Ju, MD, active but no longer recruiting.","summary":"Borderline of CME/D3 Dissection for Local Advanced Right-sided Colon Cancer is a phase 3, randomised interventional study registered as NCT06709144 by Haixing Ju, MD, with a registry enrolment figure of 896 participants, started 2024-07-01 and due to reach its primary completion in 2027-06-30. Interventions recorded: SMA lymph node dissection; SMV lymph node dissection. Conditions listed: Colon Cancer. Primary outcome: 3 year DFS. Colorectal eligibility wording from the registry: \"* right side colon cancer(The primary lesion is located in the ileocecal region, ascending colon, hepatic flexure of colon, or proximal transverse colon)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06709144","url":"https://clinicaltrials.gov/study/NCT06709144"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06709144","phase":"3","setting":"Borderline of CME/D3 Dissection for Local Advanced Right-sided Colon Cancer(BLARCC): a Prospective, Multicenter Randomized Control Clinical Trial","sponsor":"Haixing Ju, MD","started":"2024-07-01","startedType":"actual","enrolled":896,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06572813","kind":"trial","name":"Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for Metastatic Pancreatic Cancer","aka":["CISPD-7"],"tldr":"A phase 1/2 trial of sintilimab and fOLFIRINOX / mFOLFIRINOX in pancreatic cancer, run by First Affiliated Hospital of Zhejiang University, now recruiting.","summary":"Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for Metastatic Pancreatic Cancer is a phase 1/2, interventional study registered as NCT06572813 by First Affiliated Hospital of Zhejiang University, with a registry enrolment figure of 63 participants, started 2024-11-15 and due to reach its primary completion in 2026-09-01. Interventions recorded: Bortezomib Injection; Sintilimab; mFOLFIRINOX. Conditions listed: Pancreas Cancer. Primary outcome: Phase 1: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0; Phase 2: Objective reponse rate (ORR). Pancreatic eligibility wording from the registry: \"* Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06572813","url":"https://clinicaltrials.gov/study/NCT06572813"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["sintilimab","folfirinox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06572813","phase":"1/2","setting":"Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for First-line Treatment of Metastatic Pancreatic Cancer：An Exploratory Clinical Trial","sponsor":"First Affiliated Hospital of Zhejiang University","started":"2024-11-15","startedType":"actual","enrolled":63,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06968221","kind":"trial","name":"Bovine Reinforcement in Stomach, Colorectal and Lung Operation","aka":[],"tldr":"A phase 3 trial of Bioabsorbable Staple Line Reinforcemen in colorectal cancer, run by Shanghai Cingularbio Co. Ltd, now recruiting.","summary":"Bovine Reinforcement in Stomach, Colorectal and Lung Operation is a phase 3 interventional study registered as NCT06968221 by Shanghai Cingularbio Co. Ltd, with 172 participants planned, started 2025-05-01 and due to reach its primary completion in 2025-09-01. Interventions recorded: Bioabsorbable Staple Line Reinforcemen.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06968221","url":"https://clinicaltrials.gov/study/NCT06968221"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06968221","phase":"3","setting":"A Study on the Safety and Efficacy of Using Cingular Bovine Pericardium Anastomosis Reinforcement Membrane for Tissue Reinforcement and Hemostasis at Anastomotic Sites","sponsor":"Shanghai Cingularbio Co. Ltd","started":"2025-05-01","startedType":"actual","enrolled":172,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05120271","kind":"trial","name":"BOXR1030 T Cells in Subjects With Advanced GPC3-Positive Solid Tumors","aka":["DUET-1"],"tldr":"A phase 1/2 trial of CAR-GPC3 T Cells in hepatocellular carcinoma, non-small-cell lung cancer, merkel cell carcinoma and sarcomas, run by Sotio Biotech Inc., active and no longer recruiting.","summary":"BOXR1030 T Cells in Subjects With Advanced GPC3-Positive Solid Tumors is a phase 1/2 interventional study registered as NCT05120271 by Sotio Biotech Inc., with 7 participants enrolled, started 2022-10-26 and due to reach its primary completion in 2025-10-24. Interventions recorded: CAR-GPC3 T Cells.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05120271","url":"https://clinicaltrials.gov/study/NCT05120271"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","nsclc","merkel-cell-carcinoma","sarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sotio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05120271","phase":"1/2","setting":"A First-in-Human, Phase 1/2, Dose Escalation Study of BOXR1030 T Cells in Subjects With Advanced GPC3-Positive Solid Tumors","sponsor":"Sotio Biotech Inc.","started":"2022-10-26","startedType":"actual","enrolled":7,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05393466","kind":"trial","name":"BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)","aka":[],"tldr":"A phase 1/2 trial in lung cancer, run by Xcovery Holdings, Inc., not yet recruiting.","summary":"BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) is a phase 1/2, interventional study registered as NCT05393466 by Xcovery Holdings, Inc., with a registry enrolment figure of 30 participants, started 2026-07-01 and due to reach its primary completion in 2028-01-30. Interventions recorded: BPI-361175. Conditions listed: Non-small Cell Lung Carcinoma. Primary outcome: The percentage of patients with adverse events and serious adverse events graded per National Cancer Institute Common Terminology Criteria for Adverse Events and dose limiting toxicities for BPI 361175; Efficacy of BPI-361175. Lung eligibility wording from the registry: \"Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent/metastatic NSCLC with EGFR mutations\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05393466","url":"https://clinicaltrials.gov/study/NCT05393466"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["xcovery"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05393466","phase":"1/2","setting":"A Phase I/II, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Xcovery Holdings, Inc.","started":"2026-07-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07645118","kind":"trial","name":"Brachytherapy Followed by Nivolumab Prior to Surgery in Rectal Cancer","aka":["IMPERIA"],"tldr":"A phase 2 trial of nivolumab in colorectal cancer, run by Dr. Te Vuong, not yet recruiting.","summary":"Brachytherapy Followed by Nivolumab Prior to Surgery in Rectal Cancer is a phase 2, interventional study registered as NCT07645118 by Dr. Te Vuong, with a registry enrolment figure of 10 participants, started 2026-07 and due to reach its primary completion in 2028-12. Interventions recorded: Nivolumab; HDRBET; Total Mesorectal Excision (TME). Conditions listed: Locally Advanced Rectal Cancer. Primary outcome: Pathologic complete response (pCR). Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma arising within 5 to 15 cm of the anal verge as measured by sigmoidoscopy or MRI\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07645118","url":"https://clinicaltrials.gov/study/NCT07645118"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07645118","phase":"2","setting":"Pilot Evaluation of the Immunogenic Potentiation of Neo-adjuvant Brachytherapy Followed by Nivolumab Immunotherapy Without Chemotherapy in Stage II/III Locally Advanced Mismatch Repair Proficient Rectal Cancer","sponsor":"Dr. Te Vuong","started":"2026-07","startedType":"estimated","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06793332","kind":"trial","name":"BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC","aka":["BALISTA"],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Fudan University, now recruiting.","summary":"BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC is a phase 2, interventional study registered as NCT06793332 by Fudan University, with a registry enrolment figure of 39 participants, started 2024-12-17 and due to reach its primary completion in 2026-01-31. Interventions recorded: Ivonescimab Combined With TROP2 ADC. Conditions listed: Triple-Negative Breast Cancer (TNBC); Brain Metastases. Triple-negative eligibility wording from the registry: \"Patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer who have failed treatment with taxane drugs are included\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06793332","url":"https://clinicaltrials.gov/study/NCT06793332"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic","brain-metastases"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06793332","phase":"2","setting":"Prospective, One-arm, Phase II Clinical Study of Ivoximab Combined With TROP2 ADC in the Treatment of Brain Metastases in Triple-negative Breast Cancer","sponsor":"Fudan University","started":"2024-12-17","startedType":"actual","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"bre12-158","kind":"trial","name":"BRE12-158 (Hoosier Oncology Group)","aka":["BRE12-158","HCRN BRE12-158"],"tldr":"BRE12-158 sequenced the cancer left behind after pre-operative chemotherapy and matched a targeted drug to it. Matched therapy was no better than the doctor's usual choice, which increasingly meant capecitabine, and blood-borne tumour DNA after surgery predicted who relapsed.","summary":"BRE12-158 (NCT02101385) enrolled 193 patients with triple-negative breast cancer and residual disease after neoadjuvant chemotherapy between March 2014 and December 2018; residual tumours were sequenced, a molecular tumour board adjudicated results, and patients with a target were randomised to four cycles of genomically directed monotherapy (arm A) or treatment of physician's choice (arm B), with patients lacking a target assigned to arm B. Two-year disease-free survival in the randomised population was 56.6 percent (95 percent confidence interval 45 to 70) for genomically directed therapy against 62.4 percent (52 to 75) for physician's choice, with no difference in disease-free, distant disease-free or overall survival. Capecitabine uptake in the control arm rose over time and later-randomised patients had fewer distant recurrences. Circulating tumour DNA status after surgery remained a significant predictor of outcome, with clearance in some patients on post-neoadjuvant therapy; the authors concluded that capecitabine should remain the standard and that ctDNA should be a standard covariate in post-neoadjuvant trials.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02101385","url":"https://clinicaltrials.gov/study/NCT02101385"},{"label":"Radovich, Schneider et al., JCO 2022: BRE12-158 personalized therapy versus treatment of physician's choice for residual TNBC","url":"https://doi.org/10.1200/JCO.21.01657"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":["ctdna","rcb","efs","tnbc-residual-disease-decision"],"trials":["create-x","c-trak-tn","ea1131"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02101385","phase":"2","setting":"Triple-negative breast cancer with residual disease after neoadjuvant chemotherapy: four cycles of genomically directed therapy chosen by a molecular tumour board versus treatment of physician's choice, United States","sponsor":"Bryan Schneider, Indiana University / Hoosier Cancer Research Network","result":"2-year DFS 56.6% (genomically directed) vs 62.4% (physician's choice); no difference in DFS, DDFS or OS. Post-surgical ctDNA predicted outcome.","started":"2014-04-03","startedType":"actual","yearReported":2022,"enrolled":193,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 2 years (randomised population)","primary":true,"unit":"%","arms":[{"name":"Genomically directed therapy","value":56.6,"note":"95 percent confidence interval 45 to 70"},{"name":"Treatment of physician's choice","value":62.4,"note":"95 percent confidence interval 52 to 75"}],"source":"https://doi.org/10.1200/JCO.21.01657"}],"replication":"The ctDNA finding is echoed by c-TRAK TN (UK) and underpins the ctDNA-guided post-neoadjuvant trials now recruiting."},{"id":"breakwater","kind":"trial","name":"BREAKWATER","aka":[],"tldr":"Doubled survival, from about 15 to about 30 months, in the worst-prognosis genetic subtype of bowel cancer by adding two targeted drugs to first-line chemotherapy.","summary":"EC + mFOLFOX6: PFS 12.8 vs 7.1 months; OS 30.3 vs 15.1 months (HR 0.49; ASCO 2025 LBA3500). The FOLFIRI cohort (ASCO 2026 LBA3503) showed PFS HR 0.44 and OS HR 0.56. FDA accelerated approval December 2024 (first under Project FrontRunner), converted toward full approval in 2026. BRAF V600E disease previously had a median overall survival of around a year.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04607421","url":"https://clinicaltrials.gov/study/NCT04607421"},{"label":"ASCO 2025 LBA3500","url":"https://ascopubs.org/doi/10.1200/JCO.2025.43.17_suppl.LBA3500"},{"label":"ASCO 2026 LBA3503 (FOLFIRI)","url":"https://ascopubs.org/doi/10.1200/JCO.2026.44.17_suppl.LBA3503"}],"tags":[],"related":[],"cancers":["colorectal","braf-v600e-colorectal"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["braf","egfr"],"drugs":["encorafenib","cetuximab","folfox","folfiri"],"companies":["pfizer"],"institutions":[],"pathways":["ras-mapk"],"terms":["project-frontrunner"],"trials":["swog-s1406"],"people":["scott-kopetz","elena-elez","josep-tabernero"],"bottlenecks":[],"keyPapers":["paper-jones-non-v600-braf-colorectal-jco-2017","paper-breakwater-nat-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04607421","phase":"3","setting":"First-line BRAF V600E-mutant metastatic colorectal cancer: encorafenib + cetuximab + mFOLFOX6 (or FOLFIRI) vs chemotherapy ± bevacizumab","sponsor":"Pfizer","result":"OS 30.3 vs 15.1 months (HR 0.49); PFS 12.8 vs 7.1 months.","started":"2020-12-21","startedType":"actual","yearReported":2025,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (EC + mFOLFOX6)","unit":"months","arms":[{"name":"Encorafenib + cetuximab + mFOLFOX6","value":30.3},{"name":"Chemotherapy ± bevacizumab","value":15.1}],"hr":0.49,"source":"https://ascopubs.org/doi/10.1200/JCO.2025.43.17_suppl.LBA3500"},{"endpoint":"Progression-free survival (EC + mFOLFOX6)","primary":true,"unit":"months","arms":[{"name":"Encorafenib + cetuximab + mFOLFOX6","value":12.8},{"name":"Chemotherapy ± bevacizumab","value":7.1}],"source":"https://ascopubs.org/doi/10.1200/JCO.2025.43.17_suppl.LBA3500"},{"endpoint":"Progression-free survival (EC + FOLFIRI cohort)","unit":"months","arms":[{"name":"Encorafenib + cetuximab + FOLFIRI"},{"name":"Chemotherapy ± bevacizumab"}],"hr":0.44,"source":"https://ascopubs.org/doi/10.1200/JCO.2026.44.17_suppl.LBA3503"}],"replication":"Two independent chemotherapy-backbone cohorts within BREAKWATER reproduce the effect; BEACON established the doublet in later lines."},{"id":"nct01106040","kind":"trial","name":"Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes","aka":[],"tldr":"A phase 3 trial of Technetium-99m tilmanocept in Breast cancer and Melanoma, run by Navidea Biopharmaceuticals, completed.","summary":"Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes is a phase 3 interventional study registered as NCT01106040 by Navidea Biopharmaceuticals, with 163 participants recorded, started 2010-06 and reaching its primary completion in 2011-04. Interventions recorded: Lymphoseek. Conditions recorded: Breast Cancer, Melanoma.\n\nLinked to the drug Technetium-99m tilmanocept because the registry names it among its interventions and Breast cancer and Melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01106040","url":"https://clinicaltrials.gov/study/NCT01106040"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer","melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["tilmanocept-tc99m"],"companies":["navidea"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01106040","phase":"3","setting":"A Phase 3, Prospective, Open-Label, Multicenter Comparison Study of Lymphoseek® and Vital Blue Dye as Lymphoid Tissue Targeting Agents in Patients With Known Melanoma or Breast Cancer Who Are Undergoing Lymph Node Mapping","sponsor":"Navidea Biopharmaceuticals","started":"2010-06","yearReported":2013,"enrolled":163,"enrolledBasis":"registry","outcomes":[{"endpoint":"Concordance of Blue Dye and Lymphoseek","primary":true,"unit":"proportion of lymph nodes","arms":[{"name":"Intent-To-Treat","n":133,"value":1,"note":"95% CI 0.9840 to 1.0000; Figures from the ClinicalTrials.gov results section (first posted 2013-06-03), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01106040?tab=results"}]},{"id":"nct05498311","kind":"trial","name":"Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy","aka":["INTRABEAM"],"tldr":"A phase 2 trial of Intraoperative radiotherapy in Breast cancer, run by Institut Català d'Oncologia, with a status the registry has not verified recently.","summary":"Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy is a phase 2 interventional study registered as NCT05498311 by Institut Català d'Oncologia, with 89 participants planned, started 2016-10-20 and due to reach its primary completion in 2023-12. Interventions recorded: Intraoperative Radiotherapy (IORT), Breast conservative surgery, External Beam Hypofractionated Radiotherapy (EBRT). Conditions recorded: Breast Cancer.\n\nLinked to the technology Intraoperative radiotherapy because the registry names it (\"intraoperative radiotherapy\") among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05498311","url":"https://clinicaltrials.gov/study/NCT05498311"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["intraoperative-radiotherapy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05498311","phase":"2","setting":"Cosmetic Outcomes Following Conservative Surgery (With or Without Oncoplastic Surgery) for Breast Cancer With Intraoperative Radiotherapy (INTRABEAM) Followed by Hypofractionated External Beam Radiotherapy: a Phase II Trial","sponsor":"Institut Català d'Oncologia","started":"2016-10-20","startedType":"actual","enrolled":89,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04404283","kind":"trial","name":"Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL","aka":["ECHELON-3","Brentuximab vedotin with lenalidomide and rituximab in relapsed diffuse large B-cell lymphoma"],"tldr":"A phase 3 trial of Brentuximab vedotin, Rituximab, Lenalidomide in diffuse large b-cell lymphoma, run by Seagen, a wholly owned subsidiary of Pfizer, active and no longer recruiting.","summary":"Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL is a phase 3 interventional study registered as NCT04404283 by Seagen, a wholly owned subsidiary of Pfizer, with 239 participants enrolled, started 2020-08-20 and due to reach its primary completion in 2026-01-23. Interventions recorded: Brentuximab vedotin, Rituximab, Lenalidomide, Placebo. Conditions listed: Diffuse Large B-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04404283","url":"https://clinicaltrials.gov/study/NCT04404283"}],"tags":["ctgov-ingest"],"related":["lymphoma-roadmap","paper-echelon-3-brentuximab-lenalidomide-rituximab-dlbcl-jco-2025","polargo","starglo"],"cancers":["dlbcl"],"sections":[],"technologies":["adc","monoclonal-antibody","protac-degrader"],"targets":["cd30","cd20"],"drugs":["brentuximab-vedotin","rituximab","lenalidomide"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-echelon-3-brentuximab-lenalidomide-rituximab-dlbcl-jco-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04404283","phase":"3","setting":"A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)","sponsor":"Seagen, a wholly owned subsidiary of Pfizer","result":"Median overall survival 13.8 against 8.5 months (hazard ratio 0.63, two-sided p = 0.009) and median progression-free survival 4.2 against 2.6 months (hazard ratio 0.53).","started":"2020-08-20","startedType":"actual","yearReported":2025,"enrolled":239,"enrolledBasis":"registry","outcomes":[]},{"id":"brf113928","kind":"trial","name":"BRF113928 cohort C (dabrafenib with trametinib, untreated BRAF V600E)","aka":["BRF113928"],"tldr":"Thirty-six patients showed that the melanoma combination of a BRAF and a MEK drug also works in the small slice of lung cancers with the same mutation.","summary":"BRAF V600E occurs in 1 to 2 percent of lung adenocarcinomas. BRF113928 was a sequentially enrolled multicohort study: cohort A gave dabrafenib alone in previously treated disease, cohort B gave dabrafenib with trametinib in previously treated disease, and cohort C, reported in 2017, gave the combination to 36 previously untreated patients at 19 centres in eight countries.\n\nThe investigator-assessed confirmed objective response rate was 64 percent (23 of 36, 95 percent confidence interval 46 to 79), with two complete responses (6 percent) and 21 partial responses (58 percent). Every patient had at least one adverse event and 69 percent had a grade 3 or worse event; pyrexia is the characteristic problem with this combination.\n\nThe FDA granted the combination full approval for BRAF V600E-mutant metastatic non-small-cell lung cancer in 2017 on cohorts B and C. In England NICE TA898 (14 June 2023) recommends dabrafenib with trametinib only as first-line treatment of advanced disease, subject to the commercial arrangement; NICE TA1150 (6 May 2026) added encorafenib with binimetinib, again first line only, so a patient who has already had chemotherapy is not funded for either.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01336634","url":"https://clinicaltrials.gov/study/NCT01336634"},{"label":"BRF113928 cohort C (Lancet Oncology 2017)","url":"https://doi.org/10.1016/S1470-2045(17)30679-4"},{"label":"NICE TA898: dabrafenib plus trametinib for BRAF V600 mutation-positive advanced non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta898"}],"tags":[],"related":[],"cancers":["braf-v600e-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["braf"],"drugs":["dabrafenib","trametinib","dabrafenib-trametinib"],"companies":["novartis"],"institutions":[],"pathways":["ras-mapk"],"terms":["braf-v600-mutation","driver-mutation"],"trials":["pharos"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01336634","phase":"2","setting":"Previously untreated metastatic BRAF V600E-mutant non-small-cell lung cancer: dabrafenib 150 mg twice daily with trametinib 2 mg daily, single arm, with investigator-assessed objective response as the primary endpoint","sponsor":"GlaxoSmithKline, later Novartis","result":"Confirmed objective response 64 percent (23 of 36), with 6 percent complete responses; grade 3 or worse adverse events in 69 percent.","started":"2011-08-05","startedType":"actual","yearReported":2017,"enrolled":36,"enrolledBasis":"treated","enrolledNote":"36 previously untreated patients were enrolled into cohort C; the registry enrolment figure covers all three cohorts of the study.","outcomes":[{"endpoint":"Objective response rate (investigator assessed, untreated cohort)","primary":true,"unit":"%","arms":[{"name":"Dabrafenib with trametinib","n":36,"value":64}],"ci":[46,79],"source":"https://doi.org/10.1016/S1470-2045(17)30679-4"}],"replication":"PHAROS reproduced the effect with encorafenib and binimetinib in both untreated and previously treated BRAF V600E-mutant disease."},{"id":"brightness","kind":"trial","name":"BrighTNess","aka":[],"tldr":"BrighTNess showed that adding the platinum drug carboplatin to standard chemotherapy before surgery makes triple-negative breast tumours vanish completely more often, and later that fewer people relapsed, while the PARP inhibitor veliparib added on top made no difference.","summary":"BrighTNess was a double-blind placebo-controlled phase 3 trial in stage II to III triple-negative breast cancer. Patients were randomised two to one to one to neoadjuvant paclitaxel with carboplatin and veliparib, paclitaxel with carboplatin and placebo, or paclitaxel with two placebos, all followed by doxorubicin and cyclophosphamide before surgery.\n\nAdding carboplatin and veliparib to paclitaxel significantly increased the pathological complete response rate compared with paclitaxel alone, but adding veliparib to carboplatin and paclitaxel did not increase it further, so the benefit came from carboplatin. Long-term follow-up published in 2022 showed that carboplatin also improved event-free survival, without a difference in overall survival at that point. With GeparSixto and CALGB 40603, BrighTNess put carboplatin into neoadjuvant regimens for triple-negative disease, on which KEYNOTE-522 later built.","status":"completed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02032277","url":"https://clinicaltrials.gov/study/NCT02032277"},{"label":"BrighTNess 4-year follow-up (Annals of Oncology 2022)","url":"https://doi.org/10.1016/j.annonc.2022.01.009"}],"tags":["subtype-trials"],"related":[],"cancers":["tnbc-early","tnbc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","paclitaxel","doxorubicin","cyclophosphamide","veliparib"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":["geparsixto","calgb-40603","keynote-522","brocade3"],"people":["sibylle-loibl","charles-geyer"],"bottlenecks":[],"keyPapers":["paper-brightness-lancet-oncol-2018"],"journals":[],"dependsOn":[],"notes":["Four-year follow-up (Annals of Oncology 2022, median 4.5 years): event-free survival hazard ratio 0.63 (0.43 to 0.92) for carboplatin plus veliparib with paclitaxel against paclitaxel alone, 1.12 (0.72 to 1.72) against carboplatin with paclitaxel, and 0.57 (0.36 to 0.91) for carboplatin with paclitaxel against paclitaxel alone in a post hoc analysis; overall survival and rates of myelodysplasia, acute myeloid leukaemia and second cancers did not differ. Four UK sites (Bristol, Charing Cross, Nottingham, Royal Stoke)."],"nct":"NCT02032277","phase":"3","setting":"Stage II to III triple-negative breast cancer before surgery: paclitaxel with carboplatin and the PARP inhibitor veliparib, paclitaxel with carboplatin and placebo, or paclitaxel alone, each followed by doxorubicin and cyclophosphamide","sponsor":"AbbVie","result":"Carboplatin added to neoadjuvant paclitaxel raised the pathological complete response rate and improved event-free survival in triple-negative breast cancer; veliparib added nothing to carboplatin.","started":"2014-04-02","startedType":"actual","yearReported":2018,"enrolled":634,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathological complete response (breast and lymph nodes)","primary":true,"unit":"%","arms":[{"name":"Paclitaxel + carboplatin + veliparib","n":316,"value":53},{"name":"Paclitaxel + carboplatin","n":160,"value":58},{"name":"Paclitaxel alone","n":158,"value":31}],"p":"<0.0001 (veliparib + carboplatin vs paclitaxel alone); 0.36 (vs paclitaxel + carboplatin)","source":"https://doi.org/10.1016/s1470-2045(18)30111-6"}]},{"id":"brocade3","kind":"trial","name":"BROCADE3","aka":[],"tldr":"BROCADE3 added the PARP inhibitor veliparib to carboplatin and paclitaxel for advanced breast cancer in women with an inherited BRCA mutation. It delayed progression by about two months but did not lengthen life, and the drug was never licensed; the long survival on chemotherapy alone showed how active platinum is in this group.","summary":"BROCADE3 (NCT02163694) randomised 513 patients (509 in the intention-to-treat population with a centrally confirmed germline BRCA mutation; 337 veliparib, 172 placebo) between July 2014 and January 2018 to carboplatin AUC 6 on day 1 and paclitaxel 80 mg/m2 on days 1, 8 and 15 of 21 with veliparib 120 mg or placebo twice daily on days minus 2 to 5, continued at an intensified dose as monotherapy if chemotherapy stopped before progression; the control group could cross over to veliparib on progression. Median progression-free survival was 14.5 versus 12.6 months (hazard ratio 0.71, 95 percent confidence interval 0.57 to 0.88, p 0.0016). Final overall survival (European Journal of Cancer 2024) was 32.4 versus 28.2 months (hazard ratio 0.916, 0.736 to 1.140, p 0.434). Grade 3 or worse neutropenia occurred in 81 versus 84 percent, anaemia 42 versus 40 percent and thrombocytopenia 40 versus 28 percent. The trial matters for triple-negative disease because roughly half of germline BRCA breast cancers are triple-negative and because it is the only phase 3 of a PARP inhibitor given with, rather than instead of, chemotherapy: the progression-free survival gain did not become a survival gain, and the 28-month median survival of the carboplatin and paclitaxel control arm is the benchmark for platinum doublets in BRCA-mutated disease. AbbVie did not seek approval. UK sites (registry, 4): Bristol, Hull, Nottingham, University Hospitals Birmingham.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02163694","url":"https://clinicaltrials.gov/study/NCT02163694"},{"label":"Dieras et al., Lancet Oncology 2020: veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3)","url":"https://doi.org/10.1016/S1470-2045(20)30447-2"},{"label":"BROCADE3 final overall survival (European Journal of Cancer 2024)","url":"https://doi.org/10.1016/j.ejca.2024.113580"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic","breast-hr-positive"],"sections":[],"technologies":["parp-inhibitor","platinum","cytotoxic-chemotherapy"],"targets":["parp","brca"],"drugs":["veliparib","carboplatin","paclitaxel"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":["gbrca-mutation"],"trials":["olympiad","embraca","brightness","tnt"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 4): University Hospitals Bristol, Hull University Teaching Hospitals, Nottingham University Hospitals, University Hospitals Birmingham."],"nct":"NCT02163694","phase":"3","setting":"Germline BRCA1 or BRCA2-mutated HER2-negative metastatic or locally advanced unresectable breast cancer, up to two prior chemotherapy lines: carboplatin and paclitaxel with veliparib or placebo, continued as veliparib monotherapy if chemotherapy stopped, 147 hospitals in 36 countries","sponsor":"AbbVie","result":"PFS 14.5 vs 12.6 months (HR 0.71, p 0.0016); final OS 32.4 vs 28.2 months (HR 0.92, p 0.43). Not licensed.","started":"2014-04-08","startedType":"actual","yearReported":2020,"enrolled":513,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (investigator)","primary":true,"unit":"months","arms":[{"name":"Veliparib + carboplatin + paclitaxel","n":337,"value":14.5},{"name":"Placebo + carboplatin + paclitaxel","n":172,"value":12.6}],"hr":0.71,"ci":[0.57,0.88],"p":"0.0016","source":"https://doi.org/10.1016/S1470-2045(20)30447-2"},{"endpoint":"Overall survival (final)","unit":"months","arms":[{"name":"Veliparib + carboplatin + paclitaxel","value":32.4},{"name":"Placebo + carboplatin + paclitaxel","value":28.2}],"hr":0.916,"ci":[0.736,1.14],"p":"0.434","source":"https://doi.org/10.1016/j.ejca.2024.113580"}],"replication":"OlympiAD and EMBRACA (PARP inhibitor instead of chemotherapy) also improved progression-free but not overall survival in germline BRCA breast cancer."},{"id":"bruin-cll-321","kind":"trial","name":"BRUIN CLL-321","aka":[],"tldr":"The randomised trial that confirmed pirtobrutinib works after other BTK inhibitors fail, leading to full approval in December 2025.","summary":"BRUIN CLL-321, trial NCT04666038 sponsored by Eli Lilly through Loxo and reported at ASH 2024 and in JCO in 2025, is the randomised trial that confirmed the non-covalent BTK inhibitor pirtobrutinib works after covalent BTK inhibitors fail in relapsed or refractory chronic lymphocytic leukaemia, leading to full approval on 3 December 2025. It randomised 238 patients to pirtobrutinib or investigator's choice of idelalisib-rituximab or bendamustine-rituximab, met its primary progression-free survival endpoint with a longer time to next treatment, while overall survival was not different because of crossover, and the label was broadened to any prior covalent BTK inhibitor. Whether pirtobrutinib belongs in the frontline, which CLL-313 and CLL-314 test, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04666038","url":"https://clinicaltrials.gov/study/NCT04666038"}],"tags":[],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["btk"],"drugs":["pirtobrutinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jennifer-brown"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04666038","phase":"3","setting":"Relapsed/refractory CLL/SLL after a covalent BTK inhibitor: pirtobrutinib vs investigator's choice (idelalisib-rituximab or bendamustine-rituximab)","sponsor":"Eli Lilly / Loxo","result":"PFS 11.2 vs 8.7 months; HR 0.58.","started":"2021-03-09","startedType":"actual","yearReported":2024,"enrolled":238,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Pirtobrutinib","n":119,"value":11.2},{"name":"Idelalisib-rituximab or bendamustine-rituximab","n":119,"value":8.7}],"hr":0.58,"source":"https://www.ajmc.com/view/fda-grants-full-approval-to-pirtobrutinib-for-cll-sll"}],"replication":"BRUIN phase 1/2 (n>300 CLL) showed ORR ~82% after covalent BTKi; frontline randomised trials (CLL-313, CLL-314) pending."},{"id":"nct04933903","kind":"trial","name":"BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab","aka":["BrUOG 397"],"tldr":"A phase 2 trial of ipilimumab and nivolumab in lung cancer, run by Brown University, now recruiting.","summary":"BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab is a phase 2, interventional study registered as NCT04933903 by Brown University, with a registry enrolment figure of 25 participants, started 2021-10-05 and due to reach its primary completion in 2026-10. Interventions recorded: Ipilimumab; Nivolumab; SBRT. Conditions listed: Non Small Cell Lung Cancer. Primary outcome: Number of Patients with a Pathologic Response. Lung eligibility wording from the registry: \"Pathologically confirmed NSCLC\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04933903","url":"https://clinicaltrials.gov/study/NCT04933903"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","sbrt"],"targets":[],"drugs":["ipilimumab","nivolumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04933903","phase":"2","setting":"BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab for Patients With Resectable Stage IB - III Non-Small Cell Lung Cancer","sponsor":"Brown University","started":"2021-10-05","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"bwel","kind":"trial","name":"BWEL (Breast Cancer Weight Loss, Alliance A011401)","aka":[],"tldr":"BWEL is a trial of more than 3,000 women testing whether losing weight after breast cancer treatment reduces recurrence. The programme achieved weight loss; the effect on recurrence was not clearly shown at the first analysis.","summary":"BWEL randomised 3,181 women within 12 months of diagnosis to a two-year telephone-delivered lifestyle programme (calorie restriction, 150-225 minutes of moderate activity per week, 42 coaching calls) plus health education, or health education alone; the primary endpoint was invasive disease-free survival. The intervention produced significantly greater weight loss at 12 and 24 months than the control arm. Primary efficacy results were presented in late 2025 and reported as not demonstrating a statistically significant improvement in invasive disease-free survival at the planned analysis; full peer-reviewed publication and longer follow-up are awaited, and the effect sizes below should be checked against the publication when available. Interpretation is contested: the weight loss achieved was modest (a few percent of body weight), follow-up is relatively short for HR-positive disease, and secondary cardiometabolic and quality-of-life benefits were seen. BWEL is the largest lifestyle-intervention trial ever run in cancer survivors and its design (telephone coaching, scalable) remains the template.","status":"mixed","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT02750826","url":"https://clinicaltrials.gov/study/NCT02750826"},{"label":"BWEL design paper (npj Breast Cancer 2017)","url":"https://doi.org/10.1038/s41523-017-0040-8"}],"tags":[],"related":["idea-nl-glp1-adjuvant-hr-breast"],"cancers":["breast-hr-positive","breast-her2-positive"],"sections":["nutrition-lifestyle"],"technologies":["dietitian-led-weight-loss-breast","exercise-oncology","endocrine-therapy"],"targets":[],"drugs":[],"companies":["alliance-oncology"],"institutions":["dana-farber"],"pathways":[],"terms":["energy-balance","obesity-related-cancers","efs"],"trials":[],"people":[],"bottlenecks":["b-survivorship","b-negative-results"],"keyPapers":["paper-ligibel-npj-breast-cancer"],"journals":[],"dependsOn":[],"notes":["Record written before the peer-reviewed primary publication; numerical results deliberately omitted."],"nct":"NCT02750826","phase":"3","setting":"Stage II-III HR-positive or HER2-positive breast cancer, BMI at least 27: 2-year telephone-based weight-loss intervention plus health education vs health education alone","sponsor":"Alliance for Clinical Trials in Oncology / NCI","result":"Weight loss achieved; primary iDFS endpoint not met at first analysis (presented 2025; publication pending, verify).","started":"2016-09-16","startedType":"actual","yearReported":2025,"enrolled":3181,"enrolledBasis":"registry","outcomes":[{"endpoint":"Invasive disease-free survival","primary":true,"unit":"months","arms":[{"name":"Telephone weight-loss intervention + health education","note":"Event-driven primary analysis not yet published; ClinicalTrials.gov lists primary completion in 2030. Only weight and quality-of-life secondary analyses have been reported (2025-2026)."},{"name":"Health education alone"}],"source":"https://clinicaltrials.gov/study/NCT02750826"},{"endpoint":"Weight change from baseline at 1 year","unit":"%","arms":[{"name":"Telephone weight-loss intervention + health education","n":1591,"value":-4.7,"note":"Mean -4.3 kg vs +0.9 kg; 3,180 women analysed"},{"name":"Health education alone","n":1589,"value":1}],"p":"<0.001","source":"https://doi.org/10.1001/jamaoncol.2025.2738"}],"replication":"Weight loss reproduces the LISA trial (letrozole-treated women) and the SUCCESS-C lifestyle arm; whether it changes breast cancer recurrence remains untested pending the BWEL primary analysis."},{"id":"nct05322590","kind":"trial","name":"BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma","aka":["ASIST"],"tldr":"A phase 1/2 trial of BXQ-350 in colorectal cancer, run by Bexion Pharmaceuticals, Inc., active and no longer recruiting.","summary":"BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma is a phase 1/2 interventional study registered as NCT05322590 by Bexion Pharmaceuticals, Inc., with 195 participants enrolled, started 2023-01-09 and due to reach its primary completion in 2026-04. Interventions recorded: BXQ-350.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05322590","url":"https://clinicaltrials.gov/study/NCT05322590"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["icon-plc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05322590","phase":"1/2","setting":"A Phase 1b/2 Placebo Controlled, Double Blinded Study on the Efficacy and Safety of BXQ-350 in Combination With mFOLFOX7 and Bevacizumab in Newly Diagnosed Metastatic Colorectal Carcinoma","sponsor":"Bexion Pharmaceuticals, Inc.","started":"2023-01-09","startedType":"actual","enrolled":195,"enrolledBasis":"registry","outcomes":[]},{"id":"c-144-01","kind":"trial","name":"C-144-01","aka":[],"tldr":"The single-arm study that got the first cell therapy for a solid tumour approved: one in three patients responded after everything else had failed.","summary":"C-144-01, trial NCT02360579 sponsored by Iovance and reported in 2021, is the single-arm study that got the first cell therapy for a solid tumour approved: one in three patients with advanced melanoma that had progressed after anti-PD-1 therapy, and BRAF and MEK inhibitors where applicable, responded to a single infusion of lifileucel tumour-infiltrating lymphocytes. In 153 patients the objective response rate in the pivotal cohort was 31.4 percent, and the five-year analysis showed a median duration of response of about three years with roughly a third of responders still responding, leading to accelerated FDA approval in February 2024. OnCo links it to melanoma, TIL therapy, lifileucel, Iovance and Amod A. Sarnaik, and the result is consistent with decades of NCI Surgery Branch TIL series. Randomised confirmation rests on TILVANCE-301 in the first line with pembrolizumab.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02360579","url":"https://clinicaltrials.gov/study/NCT02360579"}],"tags":[],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["til-therapy"],"targets":[],"drugs":["lifileucel"],"companies":["iovance"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["amod-sarnaik"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02360579","phase":"2","setting":"Advanced melanoma progressing after anti-PD-1 (and BRAF/MEK if applicable): single infusion of lifileucel TIL","sponsor":"Iovance","result":"ORR 31.4%; median DOR 36.5 months (5-year analysis).","started":"2015-09-24","startedType":"actual","yearReported":2021,"enrolled":153,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Lifileucel","n":153,"value":31.4}],"source":"https://www.iovance.com"}],"replication":"Consistent with decades of NCI Surgery Branch TIL series; randomised confirmation pending (TILVANCE-301)."},{"id":"c-post","kind":"trial","name":"C-POST (cemiplimab after surgery and radiotherapy for high-risk skin squamous cell carcinoma)","aka":["C-POST","Cemiplimab POST-operative trial"],"tldr":"This is the first trial to show that a drug given after surgery and radiotherapy stops the most dangerous skin squamous cancers coming back. Two years on, 87 out of 100 treated were still free of the cancer, against 64 out of 100 given a dummy.","summary":"Almost everyone with a cutaneous squamous cell carcinoma is cured by an operation. The group C-POST was built for is the small minority who are not: those with extracapsular nodal spread, three or more involved nodes, bone invasion, in-transit metastases or perineural invasion, who have already had surgery and radiotherapy and whose remaining risk is high. Until 2025 they were simply watched.\n\nFour hundred and fifteen patients were randomised to cemiplimab (209) or placebo (206), given at 350 mg every three weeks for twelve weeks and then 700 mg every six weeks for up to a further 36 weeks, 48 weeks in all. At a median follow-up of 24 months, disease-free survival strongly favoured cemiplimab: 24 events against 65, a hazard ratio for recurrence or death of 0.32 (95 per cent confidence interval 0.20 to 0.51, p<0.001). Estimated 24-month disease-free survival was 87.1 per cent (80.3 to 91.6) against 64.1 per cent (55.9 to 71.1). Both components moved: locoregional recurrence in 9 against 40 patients (hazard ratio 0.20, 0.09 to 0.40) and distant recurrence in 10 against 26 (hazard ratio 0.35, 0.17 to 0.72).\n\nThe cost is real but modest against that effect. Grade 3 or higher adverse events occurred in 23.9 per cent of the cemiplimab group against 14.2 per cent of the placebo group, and 9.8 per cent stopped because of adverse events against 1.5 per cent.\n\nOverall survival was not the primary endpoint and is not yet mature. The comparison worth holding beside this trial is TROG 05.01, whose radiotherapy-alone arm gave 83 per cent freedom from locoregional relapse at five years in a partly overlapping population: adjuvant immunotherapy is being added on top of local treatment that already works well, which is why the absolute gain, 23 percentage points at two years, is larger than most adjuvant trials in any cancer.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03969004","url":"https://clinicaltrials.gov/study/NCT03969004"},{"label":"Primary report (New England Journal of Medicine 2025)","url":"https://doi.org/10.1056/NEJMoa2502449"},{"label":"Primary report on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/40454639/"}],"tags":[],"related":[],"cancers":["cutaneous-scc","advanced-cutaneous-scc","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["cemiplimab"],"companies":["regeneron","sanofi"],"institutions":[],"pathways":[],"terms":["perineural-invasion","irae","radiotherapy-for-skin-cancer","tmb"],"trials":["empower-cscc-1","trog-05-01","neoadjuvant-cemiplimab-cscc"],"people":[],"bottlenecks":[],"keyPapers":["paper-c-post-adjuvant-cemiplimab-nejm-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03969004","phase":"3","setting":"Local or regional cutaneous squamous cell carcinoma after surgical resection and postoperative radiotherapy, at high risk of recurrence through nodal features (extracapsular extension with a node of 20 mm or more, or at least three involved nodes) or non-nodal features (in-transit metastases, a T4 lesion with bone invasion, perineural invasion, or a locally recurrent tumour with at least one other risk feature): cemiplimab against placebo for up to 48 weeks, with disease-free survival as the primary endpoint","sponsor":"Regeneron Pharmaceuticals and Sanofi","result":"Disease-free survival at 24 months 87.1 per cent with adjuvant cemiplimab against 64.1 per cent with placebo (hazard ratio 0.32, 95 per cent confidence interval 0.20 to 0.51, p<0.001), with grade 3 or higher adverse events in 23.9 against 14.2 per cent.","started":"2019-06-04","startedType":"actual","yearReported":2025,"enrolled":415,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 24 months","primary":true,"unit":"%","arms":[{"name":"Adjuvant cemiplimab","n":209,"value":87.1,"note":"95 per cent confidence interval 80.3 to 91.6; 24 events"},{"name":"Placebo","n":206,"value":64.1,"note":"95 per cent confidence interval 55.9 to 71.1; 65 events"}],"hr":0.32,"ci":[0.2,0.51],"p":"<0.001","source":"https://doi.org/10.1056/nejmoa2502449"},{"endpoint":"Freedom from locoregional recurrence","unit":"events","arms":[{"name":"Adjuvant cemiplimab","n":209,"value":9},{"name":"Placebo","n":206,"value":40}],"hr":0.2,"ci":[0.09,0.4],"source":"https://doi.org/10.1056/nejmoa2502449"},{"endpoint":"Freedom from distant recurrence","unit":"events","arms":[{"name":"Adjuvant cemiplimab","n":209,"value":10},{"name":"Placebo","n":206,"value":26}],"hr":0.35,"ci":[0.17,0.72],"source":"https://doi.org/10.1056/nejmoa2502449"},{"endpoint":"Grade 3 or higher adverse events","unit":"%","arms":[{"name":"Adjuvant cemiplimab","n":209,"value":23.9,"note":"discontinuation for adverse events in 9.8 per cent"},{"name":"Placebo","n":206,"value":14.2,"note":"discontinuation for adverse events in 1.5 per cent"}],"source":"https://doi.org/10.1056/nejmoa2502449"}],"replication":"The first randomised adjuvant trial in this disease. STAMP, testing adjuvant pembrolizumab in Merkel cell carcinoma, and ADMEC-O, testing adjuvant nivolumab, are the nearest parallels in a different keratinocyte-adjacent tumour."},{"id":"c-trak-tn","kind":"trial","name":"c-TRAK TN","aka":["c-TRAK-TN","cTRAK TN"],"tldr":"c-TRAK TN, run from the Royal Marsden and the Institute of Cancer Research, was the first trial to use blood tests for tumour DNA to trigger treatment in triple-negative breast cancer. A quarter of patients tested positive within a year, but most of them already had visible metastases on scans, so the test came too late to prevent relapse with pembrolizumab.","summary":"c-TRAK TN (NCT03145961) registered 208 patients between January 2018 and December 2019 with early triple-negative breast cancer and residual disease after neoadjuvant chemotherapy or stage II to III disease treated with adjuvant chemotherapy; 185 had tumour sequencing, 171 (92.4 percent) had trackable mutations and 161 entered digital PCR ctDNA surveillance every three months for 12 months (18 if samples were missed during the pandemic). ctDNA-positive patients were randomised 2 to 1 to intervention (staging scans, then pembrolizumab for a year if free of recurrence) or blinded observation; a September 2020 amendment closed the observation group. ctDNA was detected in 27.3 percent by 12 months (44 of 161; 95 percent confidence interval 20.6 to 34.9) and seven patients relapsed without prior ctDNA detection. Of 32 patients allocated to intervention, 72 percent (23) already had metastases on staging and four declined pembrolizumab; of the five who started it, none achieved sustained ctDNA clearance, so the second co-primary endpoint was not met. The trial's lesson, that ctDNA surveillance must start earlier and use more sensitive or frequent assays before it can steer adjuvant treatment, shaped the design of the ctDNA-triggered trials now recruiting.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03145961","url":"https://clinicaltrials.gov/study/NCT03145961"},{"label":"Turner et al., Annals of Oncology 2023: results of the c-TRAK TN trial","url":"https://doi.org/10.1016/j.annonc.2022.11.005"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["mrd-testing","checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":["royal-marsden","cruk"],"pathways":[],"terms":["ctdna","rcb","tnbc-residual-disease-decision"],"trials":["bre12-158","keynote-522"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 17): Royal Marsden Hospital Chelsea and Sutton, Royal Bournemouth Hospital, Velindre Cancer Centre Cardiff, Western General Hospital Edinburgh, Beatson West of Scotland Cancer Centre Glasgow, Guy's Hospital, Charing Cross Hospital, St Bartholomew's Hospital, University College London Hospitals, Maidstone Hospital, the Christie Manchester, Clatterbridge Cancer Centre, Nottingham University Hospitals, Churchill Hospital Oxford, Weston Park Hospital Sheffield, Royal Cornwall Hospital Truro."],"nct":"NCT03145961","phase":"2","setting":"Moderate and high-risk early triple-negative breast cancer after neoadjuvant or adjuvant chemotherapy: three-monthly ctDNA mutation tracking for 12 months, with ctDNA-positive patients randomised 2 to 1 to pembrolizumab or observation, 17 UK hospitals","sponsor":"Institute of Cancer Research, United Kingdom, with the Royal Marsden NIHR Biomedical Research Centre and Merck","result":"ctDNA detected in 27.3% by 12 months; 72% of ctDNA-positive patients had metastases on staging; 0 of 5 patients on pembrolizumab cleared ctDNA.","started":"2017-12-21","startedType":"actual","yearReported":2023,"enrolled":208,"enrolledBasis":"registry","outcomes":[{"endpoint":"ctDNA detection by 12 months","primary":true,"unit":"%","arms":[{"name":"Patients under ctDNA surveillance","n":161,"value":27.3}],"ci":[20.6,34.9],"source":"https://doi.org/10.1016/j.annonc.2022.11.005"},{"endpoint":"Sustained ctDNA clearance on pembrolizumab","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":5,"value":0,"note":"72 percent of ctDNA-positive patients had metastases at staging and were not eligible"}],"source":"https://doi.org/10.1016/j.annonc.2022.11.005"}],"replication":"BRE12-158 (US) also found post-surgical ctDNA prognostic."},{"id":"nct03328078","kind":"trial","name":"CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)","aka":[],"tldr":"A phase 1/2 trial of Ibrutinib in brain and spinal cord tumours, run by Curis, Inc., now recruiting.","summary":"CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL) is a phase 1/2 interventional study registered as NCT03328078 by Curis, Inc., with 152 participants planned, started 2017-12-28 and due to reach its primary completion in 2026-08. Interventions recorded: Emavusertib and Ibrutinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03328078","url":"https://clinicaltrials.gov/study/NCT03328078"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["brain-tumours","primary-cns-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["ibrutinib","emavusertib"],"companies":["curis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03328078","phase":"1/2","setting":"An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma","sponsor":"Curis, Inc.","started":"2017-12-28","startedType":"actual","enrolled":152,"enrolledBasis":"registry","outcomes":[]},{"id":"ca184-043-ipilimumab","kind":"trial","name":"CA184-043","aka":["CA184-043","ipilimumab after radiotherapy in mCRPC"],"tldr":"The first big immunotherapy trial in prostate cancer. It missed by a hair, and the way it missed, harm early and benefit late, was the clue nobody managed to cash in.","summary":"CA184-043 randomised 799 men with at least one bone metastasis from castration-resistant prostate cancer that had progressed after docetaxel to a single 8 Gy fraction of bone-directed radiotherapy followed by ipilimumab 10 mg/kg or placebo every 3 weeks for up to four doses, with maintenance every 3 months for non-progressors.\n\nMedian overall survival was 11.2 months (95 percent confidence interval 9.5 to 12.7) with ipilimumab and 10.0 months (8.3 to 11.0) with placebo, hazard ratio 0.85 (0.72 to 1.00, p=0.053). It missed significance, and the proportional hazards assumption was violated (p=0.0031), which is the interesting part. A piecewise hazard model showed the hazard ratio changed with time: 1.46 (1.10 to 1.95) in the first 5 months, 0.65 (0.50 to 0.85) from 5 to 12 months and 0.60 (0.43 to 0.86) beyond 12 months. Ipilimumab appeared to kill men early and help those who survived the early period.\n\nThe toxicity explains the first phase. Grade 3 to 4 immune-related adverse events occurred in 101 of 393 men (26 percent) against 11 of 396 (3 percent), including diarrhoea in 64 (16 percent) against seven (2 percent) and colitis in 18 (5 percent) against none. Four deaths were attributed to study drug toxicity, all with ipilimumab.\n\nThe companion trial CA184-095, in chemotherapy-naive men without visceral metastases, also failed to improve overall survival. No prospectively defined subgroup was ever found in which ipilimumab helps men with prostate cancer.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00861614","url":"https://clinicaltrials.gov/study/NCT00861614"},{"label":"CA184-043 (Lancet Oncology 2014)","url":"https://doi.org/10.1016/S1470-2045(14)70189-5"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["ctla4"],"drugs":["ipilimumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["castration-resistance","bone-metastases"],"trials":["imbassador250","impact-sipuleucel-t","keynote-921"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00861614","phase":"3","setting":"Metastatic castration-resistant prostate cancer with at least one bone metastasis, progressing after docetaxel: bone-directed radiotherapy of 8 Gy in one fraction followed by ipilimumab 10 mg/kg or placebo every 3 weeks for up to four doses, then maintenance every 3 months, with overall survival as the primary endpoint","sponsor":"Bristol-Myers Squibb","result":"Median overall survival 11.2 against 10.0 months (hazard ratio 0.85, 95 percent confidence interval 0.72 to 1.00, p=0.053), missing significance; hazard ratio 1.46 in the first 5 months and 0.60 beyond 12 months. Grade 3 to 4 immune-related adverse events 26 against 3 percent, with four treatment-related deaths.","started":"2009-05","yearReported":2014,"enrolled":799,"enrolledBasis":"randomised","enrolledNote":"799 men were randomly assigned between 26 May 2009 and 15 February 2012, 399 to ipilimumab and 400 to placebo, and all were included in the intention-to-treat analysis.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Ipilimumab 10 mg/kg after 8 Gy radiotherapy","n":399,"value":11.2,"note":"Proportional hazards violated (p=0.0031); piecewise hazard ratio 1.46 at 0 to 5 months, 0.65 at 5 to 12 months, 0.60 beyond 12 months."},{"name":"Placebo after 8 Gy radiotherapy","n":400,"value":10}],"hr":0.85,"ci":[0.72,1],"p":"0.053","source":"https://doi.org/10.1016/S1470-2045(14)70189-5"},{"endpoint":"Grade 3 to 4 immune-related adverse events","unit":"%","arms":[{"name":"Ipilimumab 10 mg/kg after 8 Gy radiotherapy","n":393,"value":26},{"name":"Placebo after 8 Gy radiotherapy","n":396,"value":3}],"source":"https://doi.org/10.1016/S1470-2045(14)70189-5"}],"replication":"CA184-095, in chemotherapy-naive men, also failed; IMbassador250 and the three KEYNOTE trials later failed with PD-1 and PD-L1 blockade."},{"id":"nct03271918","kind":"trial","name":"Cabergoline in Nonfunctioning Pituitary Adenomas","aka":[],"tldr":"A phase 3 trial of Cabergoline in Pituitary tumours, run by University of Sao Paulo General Hospital, completed.","summary":"Cabergoline in Nonfunctioning Pituitary Adenomas is a phase 3 interventional study registered as NCT03271918 by University of Sao Paulo General Hospital, with 140 participants recorded, started 2015-02-01 and reaching its primary completion in 2017-02-01. Interventions recorded: Cabergoline. Conditions recorded: Pituitary Adenoma, Nonfunctioning Pituitary Adenoma.\n\nLinked to the drug Cabergoline because the registry names it among its interventions and Pituitary tumours among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03271918","url":"https://clinicaltrials.gov/study/NCT03271918"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pituitary-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["cabergoline"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03271918","phase":"3","setting":"Dopamine Agonist Cabergoline in Residual Clinically Nonfunctioning Pituitary Adenoma After Transphenoidal Surgery: A Single Center, Open Label and Randomized Clinical Trial","sponsor":"University of Sao Paulo General Hospital","started":"2015-02-01","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"cabinet","kind":"trial","name":"CABINET (Alliance A021602)","aka":[],"tldr":"Cabozantinib tripled the time without progression in neuroendocrine tumours that had outgrown other treatments, leading to a 2025 approval.","summary":"CABINET, Alliance trial A021602, NCT03375320, sponsored by the Alliance, the NCI and Exelixis and reported in the New England Journal of Medicine in 2024, showed that cabozantinib roughly tripled the time without progression in neuroendocrine tumours that had outgrown other treatments, leading to FDA approval in March 2025. It randomised 298 patients in separate pancreatic and extra-pancreatic cohorts to cabozantinib or placebo and met its primary progression-free survival endpoint in both, with an ESMO 2025 subgroup analysis showing a large reduction in progression risk in lung and thymic tumours. OnCo links it to neuroendocrine tumours, cabozantinib and the Alliance for Clinical Trials in Oncology. Whether cabozantinib's benefit holds against, or in sequence with, radioligand therapy is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03375320","url":"https://clinicaltrials.gov/study/NCT03375320"},{"label":"ESMO 2025 subgroup (Exelixis)","url":"https://businesswire.com/news/home/20251016096352/en/Exelixis-Announces-Results-from-Subgroup-Analysis-of-CABINET-Phase-3-Pivotal-Trial-Evaluating-CABOMETYX-cabozantinib-in-Advanced-Lung-and-Thymic-Neuroendocrine-Tumors-at-ESMO-2025"}],"tags":[],"related":[],"cancers":["neuroendocrine","pancreatic-net","small-intestinal-net","lung-net"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["cabozantinib"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03375320","phase":"3","setting":"Previously treated advanced pancreatic (n=95) and extra-pancreatic (n=203) NETs: cabozantinib vs placebo","sponsor":"Alliance / NCI / Exelixis","result":"PFS HR 0.23 (pNET), 0.38 (epNET).","started":"2018-10-26","startedType":"actual","yearReported":2024,"enrolled":298,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (pancreatic NET)","primary":true,"unit":"months","arms":[{"name":"Cabozantinib","value":13.8},{"name":"Placebo","value":4.4}],"hr":0.23,"ci":[0.12,0.42],"source":"https://doi.org/10.1056/NEJMoa2403991"},{"endpoint":"Progression-free survival (extra-pancreatic NET)","primary":true,"unit":"months","arms":[{"name":"Cabozantinib","value":8.4},{"name":"Placebo","value":3.9}],"hr":0.38,"ci":[0.25,0.59],"source":"https://doi.org/10.1056/NEJMoa2403991"}]},{"id":"cabone","kind":"trial","name":"CABONE","aka":[],"tldr":"CABONE showed that the tablet cabozantinib could shrink or hold back both Ewing sarcoma and osteosarcoma that had come back after standard chemotherapy, the first drug to show meaningful activity in both bone cancers.","summary":"CABONE was a French multicentre phase 2 study of cabozantinib, an inhibitor of MET, VEGF receptors and other kinases, in 90 patients aged 12 or older with advanced Ewing sarcoma or osteosarcoma after standard therapy. The primary endpoint was objective response at six months in the Ewing cohort and objective response or six-month non-progression in the osteosarcoma cohort.\n\nBoth cohorts met their predefined activity thresholds, with objective responses in Ewing sarcoma and a high rate of six-month non-progression in osteosarcoma. Toxicity was consistent with cabozantinib in adults, including pneumothorax in some patients with lung metastases. Cabozantinib is now used off-label at relapse and is being tested in combinations in paediatric bone sarcoma trials.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02243605","url":"https://clinicaltrials.gov/study/NCT02243605"}],"tags":["subtype-trials"],"related":[],"cancers":["osteosarcoma","ewing-sarcoma","sarcoma"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["cabozantinib"],"companies":["exelixis","french-sarcoma-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["antoine-italiano"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02243605","phase":"2","setting":"Relapsed or refractory Ewing sarcoma and osteosarcoma in patients aged 12 or over: single-arm cabozantinib in two cohorts","sponsor":"Centre Léon Bérard (French Sarcoma Group)","result":"Cabozantinib met the activity thresholds in both the Ewing sarcoma and osteosarcoma cohorts.","started":"2014-12-19","startedType":"actual","yearReported":2020,"enrolled":90,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response within 6 months, Ewing sarcoma cohort","primary":true,"unit":"%","arms":[{"name":"Cabozantinib","n":39,"value":26,"note":"95% CI 13 to 42; all partial responses; median follow-up 31.3 months"}],"source":"https://doi.org/10.1016/s1470-2045(19)30825-3"},{"endpoint":"Objective response within 6 months, osteosarcoma cohort","primary":true,"unit":"%","arms":[{"name":"Cabozantinib","n":42,"value":12,"note":"95% CI 4 to 26; all partial responses"}],"source":"https://doi.org/10.1016/s1470-2045(19)30825-3"},{"endpoint":"Non-progression at 6 months, osteosarcoma cohort","primary":true,"unit":"%","arms":[{"name":"Cabozantinib","n":42,"value":33,"note":"95% CI 20 to 50"}],"source":"https://doi.org/10.1016/s1470-2045(19)30825-3"}]},{"id":"nct01639508","kind":"trial","name":"Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or A","aka":[],"tldr":"A phase 2 trial of cabozantinib in lung cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity is a phase 2, interventional study registered as NCT01639508 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 86 participants, started 2012-07 and due to reach its primary completion in 2027-07. Interventions recorded: Cabozantinib. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: objective response rate (ORR) (Group A); objective response rate (ORR) (Group B). Lung eligibility wording from the registry: \"The subject has a pathologic diagnosis of non-small cell lung carcinoma that is metastatic or unresectable\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01639508","url":"https://clinicaltrials.gov/study/NCT01639508"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["ros1-positive-nsclc","ret-fusion-nsclc","ntrk-fusion-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["cabozantinib"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01639508","phase":"2","setting":"A Phase II Study of Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2012-07","startedType":"actual","enrolled":86,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03539822","kind":"trial","name":"Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies","aka":["CAMILLA"],"tldr":"A phase 1/2 trial of cabozantinib, durvalumab and tremelimumab in colorectal cancer, run by Anwaar Saeed, now recruiting.","summary":"Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies is a phase 1/2, interventional study registered as NCT03539822 by Anwaar Saeed, with a registry enrolment figure of 117 participants, started 2018-10-22 and due to reach its primary completion in 2028-06-30. Interventions recorded: Cabozantinib; Durvalumab; Tremelimumab. Conditions listed: Gastric Cancer; Esophageal Adenocarcinoma; Hepatocellular Carcinoma; Colorectal Cancer. Primary outcome: Phase I- Maximum Tolerated Dose (MTD); Phase II- Overall Response Rate (ORR). Colorectal eligibility wording from the registry: \"* Colorectal adenocarcinoma (CRC)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03539822","url":"https://clinicaltrials.gov/study/NCT03539822"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cabozantinib","durvalumab","tremelimumab"],"companies":["astrazeneca","exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03539822","phase":"1/2","setting":"A Phase I/II Trial of Cabozantinib in Combination With Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Advanced Gastroesophageal Cancer and Other Gastrointestinal (GI) Malignancies (CAMILLA)","sponsor":"Anwaar Saeed","started":"2018-10-22","startedType":"actual","enrolled":117,"enrolledBasis":"registry","outcomes":[]},{"id":"cadance-304","kind":"trial","name":"CaDAnCe-304","aka":[],"tldr":"CaDAnCe-304 is the first phase 3 of a protein degrader in leukaemia, pitting BTK destruction against the best available BTK inhibitor.","summary":"CaDAnCe-304, sponsored by BeOne, formerly BeiGene, is the first phase 3 of a protein degrader in leukaemia, pitting BTK destruction against the best available BTK inhibitor in relapsed or refractory chronic lymphocytic leukaemia after a covalent BTK inhibitor. It is an open-label trial of about 500 patients randomised equally to the BTK degrader BGB-16673 or pirtobrutinib, each at 200 mg daily, with progression-free survival by independent review as the primary endpoint, following the CaDAnCe-101 phase 1 in which most of 66 patients responded, and enrolment runs from 2025 to 2027. OnCo links it to chronic lymphocytic leukaemia, protein degradation, BTK as a target, BGB-16673, pirtobrutinib and the bottleneck of acquired resistance. Whether degrading BTK beats inhibiting it in patients whose disease has already escaped one inhibitor is the question it exists to answer.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"Trial design (Blood 2025 abstract)","url":"https://ashpublications.org/blood/article/146/Supplement%201/5691/550156/CaDAnCe-304-a-phase-3-open-label-randomized-study"}],"tags":[],"related":[],"cancers":["cll"],"sections":[],"technologies":["protac-degrader"],"targets":["btk"],"drugs":["bgb-16673","pirtobrutinib"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Relapsed/refractory CLL/SLL after a covalent BTK inhibitor: BTK degrader BGB-16673 vs pirtobrutinib","sponsor":"BeOne (BeiGene)","enrolledBasis":"registry","outcomes":[]},{"id":"nct06566755","kind":"trial","name":"Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer","aka":[],"tldr":"A phase 3 trial of cadonilimab and bevacizumab (glioblastoma use) in colorectal cancer, run by Caigang Liu, now recruiting.","summary":"Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer is a phase 3, interventional study registered as NCT06566755 by Caigang Liu, with a registry enrolment figure of 30 participants, started 2024-02-01 and due to reach its primary completion in 2026-02-01. Interventions recorded: Cadonilimab (AK104) combined with chemotherapy and bevacizumab. Conditions listed: Colorectal Cancer. Primary outcome: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator. Colorectal eligibility wording from the registry: \"Recurrent or incurable metastatic colorectal adenocarcinoma confirmed by Histopathology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06566755","url":"https://clinicaltrials.gov/study/NCT06566755"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cadonilimab","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06566755","phase":"3","setting":"Study of Cadonilimab(AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer","sponsor":"Caigang Liu","started":"2024-02-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06367088","kind":"trial","name":"Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of cadonilimab in triple-negative breast cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, now recruiting.","summary":"Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer is a phase 2, interventional study registered as NCT06367088 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 27 participants, started 2024-05-01 and due to reach its primary completion in 2026-04-30. Interventions recorded: Cadonilimab. Conditions listed: Triple-negative Breast Cancer; Cadonilimab. Triple-negative eligibility wording from the registry: \"* Recurrent or metastatic TNBC patients;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06367088","url":"https://clinicaltrials.gov/study/NCT06367088"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cadonilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06367088","phase":"2","setting":"Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2024-05-01","startedType":"actual","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06168786","kind":"trial","name":"Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC","aka":[],"tldr":"A phase 2 trial of fruquintinib and cadonilimab in colorectal cancer, run by Huazhong University of Science and Technology, now recruiting.","summary":"Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC is a phase 2, interventional study registered as NCT06168786 by Huazhong University of Science and Technology, with a registry enrolment figure of 40 participants, started 2023-06-20 and due to reach its primary completion in 2026-02-28. Interventions recorded: Fruquintinib; Cadonilimab; SBRT. Conditions listed: Colorectal Cancer. Primary outcome: Progression-free survival (PFS). Colorectal eligibility wording from the registry: \"* Histologically or cytologically confirmed advanced Stage IV primary colorectal cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06168786","url":"https://clinicaltrials.gov/study/NCT06168786"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors","sbrt"],"targets":[],"drugs":["fruquintinib","cadonilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06168786","phase":"2","setting":"A Phase II, Single-arm, Open-label, Multi-Centers Study of Cadonilimab Combined With Fruquintinib and SBRT as A Third-line and Posterior Line Treatment in Patients With MSS Colorectal Cancer","sponsor":"Huazhong University of Science and Technology","started":"2023-06-20","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06438822","kind":"trial","name":"Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma","aka":[],"tldr":"A phase 2 trial of cadonilimab, fluorouracil, leucovorin and liposomal irinotecan in gallbladder cancer and other biliary tract cancers, run by West China Hospital, now recruiting.","summary":"Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma is a phase 2 interventional study registered as NCT06438822 by West China Hospital, with a registry enrolment figure of 51 participants, started 2024-08-30 and due to reach its primary completion in 2026-08-30. Interventions recorded: Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil. Conditions listed: Cholangiocarcinoma. Gallbladder cancer is named in the registry entry: \"1. Diagnosed with pathologically confirmed locally advanced unresectable or metastatic adenocarcinoma of the bile ducts, gallbladder, or cholangiocellular carcinoma, with primary tumors located in the intrahepatic bile d\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06438822","url":"https://clinicaltrials.gov/study/NCT06438822"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["cadonilimab","fluorouracil","leucovorin","liposomal-irinotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06438822","phase":"2","setting":"Second-line Treatment of PD-1 and CTLA-4 Blockade Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma: a Single-arm, Prospective Phase II Trial","sponsor":"West China Hospital","started":"2024-08-30","startedType":"actual","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06532617","kind":"trial","name":"Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of cadonilimab in pancreatic cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, now recruiting.","summary":"Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT06532617 by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, with a registry enrolment figure of 30 participants, started 2024-09-19 and due to reach its primary completion in 2026-08-01. Interventions recorded: Cadonilimab+S-1or Capecitabine. Conditions listed: Pancreatic Neoplasms. Primary outcome: Objective response rate (ORR). Pancreatic eligibility wording from the registry: \"* Histopathologically confirmed pancreatic ductal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06532617","url":"https://clinicaltrials.gov/study/NCT06532617"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cadonilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06532617","phase":"2","setting":"A Single-arm Phase II Clinical Study of Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Patients With Advanced Pancreatic Cancer","sponsor":"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","started":"2024-09-19","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06218810","kind":"trial","name":"Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Fudan University, now recruiting.","summary":"Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06218810 by Fudan University, with a registry enrolment figure of 53 participants, started 2024-01-01 and due to reach its primary completion in 2025-12-31. Interventions recorded: Cadonilimab + bevacizumab + FOLFOX. Conditions listed: Metastatic Colorectal Cancer; Microsatellite Stable Colorectal Carcinoma; RAS Mutation; Cadonilimab. Primary outcome: 1-year Progression Free Survival rate. Colorectal eligibility wording from the registry: \"Subjects diagnosed with metastatic colorectal adenocarcinoma by histology or cytology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06218810","url":"https://clinicaltrials.gov/study/NCT06218810"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06218810","phase":"2","setting":"Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer: A Single-Arm, Open-Label, Multicenter Phase II Study","sponsor":"Fudan University","started":"2024-01-01","startedType":"actual","enrolled":53,"enrolledBasis":"registry","outcomes":[]},{"id":"cairo3","kind":"trial","name":"CAIRO3","aka":[],"tldr":"After six cycles of chemotherapy, staying on a low-dose tablet and the antibody delayed the cancer's return without spoiling quality of life.","summary":"CAIRO3 randomised 558 patients whose metastatic colorectal cancer was stable or responding after six three-weekly cycles of capecitabine, oxaliplatin and bevacizumab to maintenance capecitabine with bevacizumab or to observation, with the induction regimen reintroduced at first progression in both arms. The primary endpoint, progression-free survival 2, was 11.7 months with maintenance against 8.5 months with observation (hazard ratio 0.67, 95% CI 0.56 to 0.81), and quality of life was not compromised. CAIRO3 is why induction followed by maintenance, rather than continuous full-dose chemotherapy, is the shape of first-line treatment in metastatic colorectal cancer.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00442637","url":"https://clinicaltrials.gov/study/NCT00442637"},{"label":"CAIRO3: maintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (Lancet 2015)","url":"https://doi.org/10.1016/S0140-6736(14)62004-3"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","antiangiogenic"],"targets":["vegf"],"drugs":["capecitabine","bevacizumab","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00442637","phase":"3","setting":"Metastatic colorectal cancer stable or better after six cycles of CAPOX and bevacizumab: maintenance capecitabine and bevacizumab against observation","sponsor":"Dutch Colorectal Cancer Group","result":"Progression-free survival 2 of 11.7 against 8.5 months (hazard ratio 0.67), with no loss of quality of life.","started":"2007-01","yearReported":2015,"enrolled":558,"enrolledBasis":"randomised","enrolledNote":"The registry lists 635 participants; 558 were randomised after induction chemotherapy in the Lancet report.","outcomes":[{"endpoint":"Progression-free survival 2","primary":true,"unit":"months","arms":[{"name":"Maintenance capecitabine and bevacizumab","n":279,"value":11.7},{"name":"Observation","n":279,"value":8.5}],"hr":0.67,"ci":[0.56,0.81],"source":"https://doi.org/10.1016/S0140-6736(14)62004-3"}]},{"id":"cairo5","kind":"trial","name":"CAIRO5","aka":[],"tldr":"The trial that chose the best chemotherapy for shrinking liver metastases enough to operate, using a panel of surgeons to judge resectability every two months.","summary":"CAIRO5 enrolled 530 patients with initially unresectable colorectal liver metastases at 46 Dutch and one Belgian centre, with resectability judged centrally by a panel of liver surgeons and radiologists at baseline and every two months. Patients with a right-sided primary or a RAS or BRAF V600E mutation were randomised to a doublet plus bevacizumab (group A) or FOLFOXIRI plus bevacizumab (group B); those with a left-sided RAS and BRAF wild-type tumour to a doublet plus bevacizumab (group C) or plus panitumumab (group D). Median progression-free survival was 9.0 against 10.6 months in groups A and B (hazard ratio 0.76, 95% CI 0.60 to 0.98, p=0.032) and 10.8 against 10.4 months in groups C and D (1.11, 0.84 to 1.48, p=0.46); groups C and D were closed early for futility. Neutropenia was much more common with the triplet (40 against 13 percent). The conclusion is FOLFOXIRI plus bevacizumab for right-sided or RAS/BRAF-mutant liver-limited disease, and bevacizumab rather than panitumumab for left-sided wild-type disease in this setting.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02162563","url":"https://clinicaltrials.gov/study/NCT02162563"},{"label":"CAIRO5: first-line systemic treatment strategies in initially unresectable colorectal cancer liver metastases (Lancet Oncology 2023)","url":"https://doi.org/10.1016/S1470-2045(23)00219-X"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","antiangiogenic","monoclonal-antibody"],"targets":["vegf","egfr","kras","braf"],"drugs":["folfoxiri","folfox","folfiri","bevacizumab","panitumumab"],"companies":[],"institutions":[],"pathways":[],"terms":["sidedness","hepatectomy","oligometastatic"],"trials":["tribe","eortc-40983"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02162563","phase":"3","setting":"Initially unresectable colorectal liver metastases, stratified by sidedness and RAS/BRAF status: a doublet plus bevacizumab, FOLFOXIRI plus bevacizumab, or a doublet plus panitumumab, with central resectability review every two months","sponsor":"Dutch Colorectal Cancer Group","result":"FOLFOXIRI plus bevacizumab better than a doublet for right-sided or RAS/BRAF-mutant disease; panitumumab no better than bevacizumab for left-sided wild-type disease.","started":"2014-07","startedType":"actual","yearReported":2023,"enrolled":530,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (right-sided or RAS/BRAF mutant)","primary":true,"unit":"months","arms":[{"name":"FOLFOXIRI plus bevacizumab","n":144,"value":10.6},{"name":"Doublet plus bevacizumab","n":147,"value":9}],"hr":0.76,"ci":[0.6,0.98],"p":"0.032","source":"https://doi.org/10.1016/S1470-2045(23)00219-X"},{"endpoint":"Progression-free survival (left-sided, RAS and BRAF wild-type)","unit":"months","arms":[{"name":"Doublet plus panitumumab","n":116,"value":10.4},{"name":"Doublet plus bevacizumab","n":114,"value":10.8}],"hr":1.11,"ci":[0.84,1.48],"p":"0.46","source":"https://doi.org/10.1016/S1470-2045(23)00219-X"}]},{"id":"nct00998738","kind":"trial","name":"Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer","aka":[],"tldr":"A phase 3 trial of Ixabepilone in Breast cancer, run by Mayo Clinic, recorded as terminated on the registry.","summary":"Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer is a phase 3 interventional study registered as NCT00998738 by Mayo Clinic, with 1 participants recorded, started 2009-11 and due to reach its primary completion in 2010-07. Interventions recorded: Calcium Gluconate, Magnesium Sulfate, Placebo, Quality-of-Life Assessment, Questionnaire Administration, Ixabepilone. Conditions recorded: Neuropathy, Pain, Recurrent Breast Carcinoma, Stage IV Breast Cancer.\n\nLinked to the drug Ixabepilone because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00998738","url":"https://clinicaltrials.gov/study/NCT00998738"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ixabepilone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00998738","phase":"3","setting":"The Use of Calcium and Magnesium for Prevention of Ixabepilone Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study","sponsor":"Mayo Clinic","started":"2009-11","enrolled":1,"enrolledBasis":"registry","outcomes":[]},{"id":"calgb-140503","kind":"trial","name":"CALGB 140503 (Alliance)","aka":[],"tldr":"CALGB 140503 showed that removing only part of a lobe is as good as removing the whole lobe for small peripheral lung cancers, so screen-detected tumours can be cured with less lung taken out.","summary":"CALGB 140503 randomised 697 patients with a peripheral non-small-cell lung cancer of 2 cm or less and nodes confirmed negative at surgery to sublobar resection (segmentectomy or wedge) or lobectomy. Lobectomy had been the standard since the 1995 Lung Cancer Study Group trial, which found more recurrences after limited resection, but that trial predated CT screening and modern staging.\n\nFive-year disease-free survival was 63.6 percent after sublobar resection and 64.1 percent after lobectomy (hazard ratio 1.01, non-inferior), and five-year overall survival was 80.3 percent and 78.9 percent. Locoregional recurrence was no higher after sublobar resection, and lung function at six months was slightly better preserved.\n\nWith the Japanese JCOG0802 trial, which found segmentectomy at least as good as lobectomy for the same tumours, the trial changed guidelines: sublobar resection is now an accepted standard for small peripheral node-negative tumours, which are the ones low-dose CT screening finds.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00499330","url":"https://clinicaltrials.gov/study/NCT00499330"},{"label":"New England Journal of Medicine 2023","url":"https://doi.org/10.1056/NEJMoa2212083"}],"tags":[],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":["robotic-surgery","low-dose-ct-screening"],"targets":[],"drugs":[],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":["lobectomy","segmentectomy","minimally-invasive-surgery"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-calgb-140503-n-engl-j-med-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00499330","phase":"3","setting":"Peripheral clinical stage IA non-small-cell lung cancer 2 cm or smaller with negative hilar and mediastinal nodes: sublobar resection (wedge or segmentectomy) versus lobectomy","sponsor":"Alliance for Clinical Trials in Oncology / NCI","result":"5-year disease-free survival 63.6% (sublobar) vs 64.1% (lobectomy), non-inferior; 5-year overall survival 80.3% vs 78.9%.","started":"2007-10-12","startedType":"actual","yearReported":2023,"enrolled":697,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Sublobar resection","n":340,"value":63.6},{"name":"Lobectomy","n":357,"value":64.1}],"hr":1.01,"source":"https://doi.org/10.1056/NEJMoa2212083"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Sublobar resection","n":340,"value":80.3},{"name":"Lobectomy","n":357,"value":78.9}],"source":"https://doi.org/10.1056/NEJMoa2212083"}],"replication":"JCOG0802/WJOG4607L (Japan, 2022) found segmentectomy non-inferior for recurrence-free survival and superior for overall survival in the same tumour size range."},{"id":"calgb-40603","kind":"trial","name":"CALGB 40603 (Alliance)","aka":["CALGB 40603","Alliance 40603"],"tldr":"CALGB 40603 showed that adding carboplatin to pre-operative chemotherapy made more triple-negative tumours disappear, but at nearly eight years of follow-up neither carboplatin nor bevacizumab clearly improved survival, in a trial too small to prove that either way.","summary":"CALGB 40603 (NCT00861705) was a randomised 2 by 2 factorial phase 2 trial in 454 registered patients (443 treated) with stage II to III triple-negative breast cancer, testing the addition of carboplatin and of bevacizumab to weekly paclitaxel followed by dose-dense doxorubicin and cyclophosphamide before surgery. Both additions raised the pathological complete response rate in the primary report (JCO 2015). At a median follow-up of 7.9 years (JCO 2022) long-term outcomes were not significantly improved by either drug, overall or in basal-like tumours defined by gene expression, in a trial not powered for those secondary endpoints. Pathological complete response (46.3 percent of patients) carried a five-year event-free survival of 85.5 percent against 56.6 percent without it, and was superior even to minimal residual disease; markers of immune activation in the pretreatment biopsy independently predicted response and survival.\n\nWith GeparSixto (disease-free survival gain) and BrighTNess (event-free survival gain) this is the third trial of the platinum debate: the pathological complete response gain is consistent across all three, the survival gain is seen in the two European trials and not in this one, and carboplatin became the platinum of the KEYNOTE-522 backbone on that combined reading.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00861705","url":"https://clinicaltrials.gov/study/NCT00861705"},{"label":"Sikov et al., JCO 2015: primary pCR results","url":"https://doi.org/10.1200/JCO.2014.57.0572"},{"label":"Shepherd et al., JCO 2022: long-term outcomes and genomic correlates","url":"https://doi.org/10.1200/JCO.21.01506"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["platinum","cytotoxic-chemotherapy"],"targets":[],"drugs":["carboplatin","paclitaxel","bevacizumab","doxorubicin","cyclophosphamide"],"companies":["alliance-oncology"],"institutions":["nci"],"pathways":[],"terms":["pcr","rcb","efs"],"trials":["geparsixto","brightness","keynote-522"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00861705","phase":"2","setting":"Stage II to III triple-negative breast cancer: neoadjuvant weekly paclitaxel with or without carboplatin and with or without bevacizumab (2 by 2 factorial), followed by dose-dense doxorubicin and cyclophosphamide, United States","sponsor":"National Cancer Institute (NCI) / Alliance","result":"Carboplatin and bevacizumab each raised pCR; at 7.9 years neither improved event-free or overall survival (not powered). pCR: 5-year EFS 85.5% vs 56.6%.","started":"2009-07-21","startedType":"actual","yearReported":2015,"enrolled":454,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 5 years by pathological response","unit":"%","arms":[{"name":"Pathological complete response","n":205,"value":85.5},{"name":"Residual disease","value":56.6,"note":"Prognostic comparison, not a randomised arm comparison"}],"source":"https://doi.org/10.1200/JCO.21.01506"}],"replication":"GeparSixto and BrighTNess found the same pCR gain from carboplatin and, unlike this trial, a disease-free or event-free survival gain."},{"id":"calgb-90401","kind":"trial","name":"CALGB 90401","aka":["CALGB 90401","Alliance 90401","bevacizumab with docetaxel in mCRPC"],"tldr":"Adding the anti-angiogenic antibody bevacizumab to chemotherapy delayed progression and shrank more tumours, but men did not live longer and four times as many died of the treatment.","summary":"CALGB 90401 randomly assigned 1,050 men with chemotherapy-naive progressive metastatic castration-resistant prostate cancer to docetaxel and prednisone with bevacizumab 15 mg/kg every 3 weeks or placebo.\n\nMedian overall survival was 22.6 months with bevacizumab against 21.5 months without, hazard ratio 0.91 (95 percent confidence interval 0.78 to 1.05, stratified log-rank p=0.181). Median progression-free survival was better with bevacizumab, 9.9 against 7.5 months (stratified log-rank p<0.001), as was objective response, 49.4 against 35.5 percent (p=0.0013).\n\nThe harm is in the safety table. Grade 3 or greater treatment-related toxicity occurred in 75.4 percent with bevacizumab against 56.2 percent (p at most 0.001), and treatment-related deaths in 4.0 against 1.2 percent (p=0.005).\n\nAn intervention that improves progression-free survival and objective response while quadrupling the treatment-related death rate and not extending life is the clearest possible argument against reading those endpoints as proxies for benefit. Bevacizumab is not used in prostate cancer.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00110214","url":"https://clinicaltrials.gov/study/NCT00110214"},{"label":"CALGB 90401 (Journal of Clinical Oncology 2012)","url":"https://doi.org/10.1200/JCO.2011.39.4767"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy"],"targets":[],"drugs":["bevacizumab","docetaxel","prednisone"],"companies":["alliance-oncology","roche-genentech"],"institutions":[],"pathways":[],"terms":["castration-resistance"],"trials":["comet-1","ready-dasatinib","tax-327"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00110214","phase":"3","setting":"Chemotherapy-naive progressive metastatic castration-resistant prostate cancer with ECOG performance status 2 or better: docetaxel 75 mg/m2 over 1 hour every 21 days with prednisone 5 mg twice daily, plus bevacizumab 15 mg/kg every 3 weeks or placebo, with overall survival as the primary endpoint","sponsor":"Cancer and Leukemia Group B, now part of the Alliance for Clinical Trials in Oncology, funded by the National Cancer Institute","result":"Median overall survival 22.6 against 21.5 months (hazard ratio 0.91, 95 percent confidence interval 0.78 to 1.05, p=0.181) despite progression-free survival 9.9 against 7.5 months and response 49.4 against 35.5 percent; treatment-related deaths 4.0 against 1.2 percent.","started":"2005-04","yearReported":2012,"enrolled":1050,"enrolledBasis":"randomised","enrolledNote":"1,050 men were randomly assigned.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Docetaxel, prednisone and bevacizumab","value":22.6},{"name":"Docetaxel and prednisone","value":21.5}],"hr":0.91,"ci":[0.78,1.05],"p":"0.181","source":"https://doi.org/10.1200/JCO.2011.39.4767"},{"endpoint":"Progression-free survival (median)","unit":"months","arms":[{"name":"Docetaxel, prednisone and bevacizumab","value":9.9},{"name":"Docetaxel and prednisone","value":7.5}],"p":"<0.001","source":"https://doi.org/10.1200/JCO.2011.39.4767"},{"endpoint":"Treatment-related deaths","unit":"%","arms":[{"name":"Docetaxel, prednisone and bevacizumab","value":4},{"name":"Docetaxel and prednisone","value":1.2}],"p":"0.005","source":"https://doi.org/10.1200/JCO.2011.39.4767"}],"replication":"COMET-1 with cabozantinib and 10TASQ10 with tasquinimod produced the same dissociation; no anti-angiogenic agent has improved survival in prostate cancer."},{"id":"calgb-9343","kind":"trial","name":"CALGB 9343","aka":[],"tldr":"CALGB 9343 showed that older women with small hormone-sensitive breast cancers taking tamoxifen gain only a small reduction in local recurrence from radiotherapy and no survival benefit, opening the door to omitting it.","summary":"CALGB 9343 randomised 636 women aged 70 or older with clinical stage I oestrogen receptor-positive breast cancer treated by lumpectomy to tamoxifen alone or tamoxifen plus radiotherapy. At ten years, locoregional recurrence was 10 percent without and 2 percent with radiotherapy, with no difference in mastectomy rates, distant disease or overall survival (Hughes and colleagues, New England Journal of Medicine 2004 and Journal of Clinical Oncology 2013). Guidelines now list radiotherapy omission as an option in this group.","status":"positive","asOf":"2026-09-16","links":[{"label":"NEJM 2004","url":"https://doi.org/10.1056/NEJMoa040587"},{"label":"JCO 2013 update","url":"https://doi.org/10.1200/JCO.2012.45.2615"}],"tags":["radiation-wave2"],"related":[],"cancers":["breast-hr-positive","breast-cancer"],"sections":[],"technologies":["imrt-igrt","active-surveillance"],"targets":[],"drugs":["tamoxifen"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":["radiotherapy-omission-early-breast-cancer"],"trials":["prime-ii","lumina"],"people":[],"bottlenecks":[],"keyPapers":["paper-hughes-n-engl-j-med","paper-hughes-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Women aged 70 or over with small oestrogen receptor-positive breast cancer after lumpectomy: tamoxifen alone versus tamoxifen plus whole-breast radiotherapy","sponsor":"Cancer and Leukemia Group B (US)","result":"10-year locoregional recurrence 10% (tamoxifen alone) vs 2% (tamoxifen plus radiotherapy); no survival difference.","yearReported":2004,"enrolled":636,"enrolledBasis":"registry","outcomes":[{"endpoint":"Locoregional recurrence at 10 years","primary":true,"unit":"%","arms":[{"name":"Tamoxifen alone","n":319,"value":10},{"name":"Tamoxifen plus radiotherapy","n":317,"value":2}]}]},{"id":"calgb-80405","kind":"trial","name":"CALGB/SWOG 80405","aka":[],"tldr":"The head-to-head test of the two biological drugs given first for bowel cancer. Overall they tied, and only the later analysis by which side of the colon the tumour started separated them.","summary":"CALGB/SWOG 80405 randomised 1,137 patients with KRAS wild-type untreated advanced colorectal cancer to cetuximab (578) or bevacizumab (559) with mFOLFOX6 or FOLFIRI chosen by the treating team. Median overall survival was 30.0 against 29.0 months (stratified hazard ratio 0.88, 95% CI 0.77 to 1.01, p=0.08), progression-free survival 10.5 against 10.6 months and response 59.6 against 55.2 percent. The trial therefore did not choose between the classes. Its secondary analyses by primary tumour side, published alongside those of FIRE-3, showed the anti-EGFR advantage is confined to left-sided tumours and that right-sided tumours do worse with cetuximab, the observation PARADIGM later confirmed prospectively.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00265850","url":"https://clinicaltrials.gov/study/NCT00265850"},{"label":"CALGB/SWOG 80405: first-line chemotherapy with cetuximab or bevacizumab in KRAS wild-type advanced colorectal cancer (JAMA 2017)","url":"https://doi.org/10.1001/jama.2017.7105"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["monoclonal-antibody","antiangiogenic","cytotoxic-chemotherapy"],"targets":["egfr","vegf","kras"],"drugs":["cetuximab","bevacizumab","folfox","folfiri"],"companies":["alliance-oncology","swog"],"institutions":[],"pathways":[],"terms":["sidedness"],"trials":["crystal-fire3","paradigm"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00265850","phase":"3","setting":"KRAS wild-type untreated advanced or metastatic colorectal cancer: cetuximab against bevacizumab, each added to physician-chosen mFOLFOX6 or FOLFIRI","sponsor":"Alliance for Clinical Trials in Oncology","result":"Median overall survival 30.0 with cetuximab against 29.0 months with bevacizumab: no significant difference.","started":"2005-11","yearReported":2017,"enrolled":1137,"enrolledBasis":"analysed","enrolledNote":"The registry lists 2,334 enrolled across the whole trial including the KRAS-unselected period before the protocol amendment; 1,137 KRAS wild-type patients were randomised and analysed in the JAMA report.","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Chemotherapy plus cetuximab","n":578,"value":30},{"name":"Chemotherapy plus bevacizumab","n":559,"value":29}],"hr":0.88,"ci":[0.77,1.01],"p":"0.08","source":"https://doi.org/10.1001/jama.2017.7105"}],"replication":"FIRE-3 found an overall survival advantage for cetuximab (28.7 against 25.0 months); PARADIGM confirmed the left-sided advantage prospectively."},{"id":"calla","kind":"trial","name":"CALLA","aka":[],"tldr":"CALLA tested adding the PD-L1 antibody durvalumab to chemoradiotherapy for locally advanced cervical cancer and found no significant benefit, in contrast to the later positive KEYNOTE-A18 trial of pembrolizumab in a higher-risk population.","summary":"CALLA randomised 770 women with locally advanced cervical cancer (FIGO 2009 stage IB2 to IIB node-positive, or III to IVA) to durvalumab or placebo given with cisplatin-based external beam radiotherapy and brachytherapy and continued for up to 24 cycles. The primary endpoint was progression-free survival.\n\nDurvalumab did not significantly improve progression-free survival, though exploratory analyses suggested benefit in tumours with high PD-L1 expression. KEYNOTE-A18, which enrolled a higher-risk population and used pembrolizumab, reported a positive result the following year, and the reasons for the difference (population, agent, radiotherapy quality) are debated.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03830866","url":"https://clinicaltrials.gov/study/NCT03830866"}],"tags":["subtype-trials"],"related":[],"cancers":["locally-advanced-cervical-cancer","cervical"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["bradley-monk"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03830866","phase":"3","setting":"Locally advanced cervical cancer: cisplatin chemoradiotherapy with durvalumab or placebo, durvalumab continued for up to two years","sponsor":"AstraZeneca","result":"Durvalumab added to chemoradiotherapy did not significantly improve progression-free survival in locally advanced cervical cancer.","started":"2019-02-15","startedType":"actual","yearReported":2023,"enrolled":770,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (investigator-assessed)","primary":true,"unit":"months","arms":[{"name":"Durvalumab + chemoradiotherapy","n":385,"note":"Not reached; median follow-up 18.5 months"},{"name":"Placebo + chemoradiotherapy","n":385,"note":"Not reached"}],"hr":0.84,"ci":[0.65,1.08],"p":"0.17","source":"https://doi.org/10.1016/s1470-2045(23)00479-5"},{"endpoint":"Progression-free survival at 12 months","unit":"%","arms":[{"name":"Durvalumab + chemoradiotherapy","n":385,"value":76},{"name":"Placebo + chemoradiotherapy","n":385,"value":73.3}],"source":"https://doi.org/10.1016/s1470-2045(23)00479-5"},{"endpoint":"Serious adverse events","unit":"%","arms":[{"name":"Durvalumab + chemoradiotherapy","n":385,"value":28},{"name":"Placebo + chemoradiotherapy","n":384,"value":23}],"source":"https://doi.org/10.1016/s1470-2045(23)00479-5"}]},{"id":"cambria","kind":"trial","name":"CAMBRIA-1 & CAMBRIA-2","aka":[],"tldr":"CAMBRIA-1 and CAMBRIA-2 are two adjuvant trials enrolling close to 10,000 women with early hormone-receptor-positive breast cancer to test whether the oral oestrogen-receptor degrader camizestrant should replace today's adjuvant hormone tablets, either as a switch after two to five years or from the start. Results are awaited.","summary":"CAMBRIA-1 and CAMBRIA-2, led by trial NCT05952557 and sponsored by AstraZeneca, are two adjuvant trials with a combined enrolment near 10,000 testing whether the oral SERD camizestrant should replace today's adjuvant hormone tablets in ER-positive, HER2-negative early breast cancer, either as a switch or from the start. CAMBRIA-1 switches about 4,300 patients to camizestrant after two to five years of standard endocrine therapy, and CAMBRIA-2 randomises about 5,500 patients upfront for seven years, with abemaciclib permitted in both arms, for a combined enrolment near 10,000. OnCo links them to camizestrant and to the bottleneck of dormant cells and minimal residual disease, which adjuvant endocrine therapy is meant to control. Results are awaited, and with lidERA already positive for giredestrant, whether oral SERDs become the adjuvant standard for everyone or only for those at high risk is the open question.","status":"active","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05952557","url":"https://clinicaltrials.gov/study/NCT05952557"}],"tags":[],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["camizestrant"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05952557","phase":"3","setting":"Adjuvant ER+/HER2- early breast cancer: camizestrant vs standard endocrine therapy, either after 2-5 years of prior ET (CAMBRIA-1) or upfront (CAMBRIA-2)","sponsor":"AstraZeneca","started":"2023-10-05","startedType":"actual","enrolled":10000,"enrolledBasis":"registry","outcomes":[],"replication":"Pending."},{"id":"camel","kind":"trial","name":"CameL","aka":[],"tldr":"The trial that made camrelizumab a first-line lung cancer option in China, one of several domestic PD-1 antibodies to reproduce the KEYNOTE-189 result.","summary":"412 patients, open label. Median progression-free survival 11.3 versus 8.3 months (hazard ratio 0.60); overall survival favoured camrelizumab in later follow-up. NMPA approval June 2020. Its companion CameL-sq did the same in squamous disease. Camrelizumab is notable for reactive cutaneous capillary endothelial proliferation, a side effect largely unique to it.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03134872","url":"https://clinicaltrials.gov/study/NCT03134872"},{"label":"Lancet Respir Med 2021","url":"https://doi.org/10.1016/S2213-2600(20)30365-9"}],"tags":["china"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["camrelizumab","carboplatin","pemetrexed"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["zhou-caicun"],"bottlenecks":[],"keyPapers":["paper-camel-lancet-respir-med-2021","paper-camel-j-thorac-oncol-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03134872","phase":"3","setting":"First-line non-squamous NSCLC without EGFR or ALK alterations, China: camrelizumab plus carboplatin and pemetrexed vs chemotherapy alone","sponsor":"Jiangsu Hengrui Pharmaceuticals","result":"PFS 11.3 vs 8.3 months, HR 0.60.","started":"2017-05-12","startedType":"actual","yearReported":2021,"enrolled":419,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Camrelizumab + chemotherapy","n":205,"value":11.3},{"name":"Chemotherapy","n":207,"value":8.3}],"hr":0.6,"source":"https://doi.org/10.1016/S2213-2600(20)30365-9"}]},{"id":"nct05440786","kind":"trial","name":"CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma","aka":["CAMPFIRE"],"tldr":"A phase 2 trial of Abemaciclib and Temozolomide in ewing sarcoma, run by Eli Lilly and Company, active and no longer recruiting.","summary":"CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma is a phase 2 interventional study registered as NCT05440786 by Eli Lilly and Company, with 46 participants enrolled, started 2022-09-20 and due to reach its primary completion in 2025-01-15. Interventions recorded: Abemaciclib, Irinotecan and Temozolomide. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05440786","url":"https://clinicaltrials.gov/study/NCT05440786"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ewing-sarcoma"],"sections":[],"technologies":["cdk46-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["abemaciclib","temozolomide"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05440786","phase":"2","setting":"A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Irinotecan and Temozolomide in Participants With Relapsed or Refractory Ewing's Sarcoma","sponsor":"Eli Lilly and Company","started":"2022-09-20","startedType":"actual","yearReported":2026,"enrolled":46,"enrolledBasis":"registry","outcomes":[{"endpoint":"PFS Assessed by BIRC by Frequentist Analysis","primary":true,"unit":"months","arms":[{"name":"Abemaciclib + Irinotecan +Temozolomide","n":30,"value":2.79,"note":"95% CI 1.74 to 13.32; Figures from the ClinicalTrials.gov results section (first posted 2026-03-12), not from a publication"},{"name":"Irinotecan +Temozolomide","n":16,"value":2.89,"note":"95% CI 1.25 to 5.13"}],"hr":0.639,"ci":[0.282,1.449],"p":"0.281","source":"https://clinicaltrials.gov/study/NCT05440786?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Abemaciclib + Irinotecan +Temozolomide","n":30,"value":21.21,"note":"95% CI 9.17 to NA; Figures from the ClinicalTrials.gov results section (first posted 2026-03-12), not from a publication"},{"name":"Irinotecan +Temozolomide","n":16,"value":6.94,"note":"95% CI 5.13 to NA"}],"hr":0.667,"ci":[0.255,1.745],"p":"0.406","source":"https://clinicaltrials.gov/study/NCT05440786?tab=results"}]},{"id":"nct06901622","kind":"trial","name":"Camrelizumab and Chemotherapy With or Without Anlotinib as First-line Treatment for Advanced Gallbladder Cancer and Extrahepatic Cholangiocarcinoma","aka":[],"tldr":"A phase 2 trial of camrelizumab, nab-paclitaxel, S-1 and anlotinib in gallbladder cancer and other biliary tract cancers, run by The First Affiliated Hospital of Zhengzhou University, now recruiting.","summary":"Camrelizumab and Chemotherapy With or Without Anlotinib as First-line Treatment for Advanced Gallbladder Cancer and Extrahepatic Cholangiocarcinoma is a phase 2, randomised interventional study registered as NCT06901622 by The First Affiliated Hospital of Zhengzhou University, with a registry enrolment figure of 50 participants, started 2024-11-08 and due to reach its primary completion in 2026-03-01. Interventions recorded: Camrelizumab, anlotinib, nab-paclitaxel, S-1, Camrelizumab, nab-paclitaxel, S-1. Conditions listed: Gallbladder Cancer and Extrahepatic Cholangiocarcinoma. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06901622","url":"https://clinicaltrials.gov/study/NCT06901622"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","extrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["camrelizumab","nab-paclitaxel","tegafur-gimeracil-oteracil","anlotinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06901622","phase":"2","setting":"A Randomized Double-cohort Exploratory Clinical Study of Camrelizumab and Chemotherapy With or Without Anlotinib as First-line Treatment for Advanced Gallbladder Cancer and Extrahepatic Cholangiocarcinoma","sponsor":"The First Affiliated Hospital of Zhengzhou University","started":"2024-11-08","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04906993","kind":"trial","name":"Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer","aka":[],"tldr":"A phase 3 trial of Camrelizumab in cervical cancer, run by Jiangsu HengRui Medicine Co., Ltd., active and no longer recruiting.","summary":"Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer is a phase 3 interventional study registered as NCT04906993 by Jiangsu HengRui Medicine Co., Ltd., with 443 participants enrolled, started 2021-07-23 and due to reach its primary completion in 2025-06-10. Interventions recorded: camrelizumab； famitinib malate and platinum-based chemotherapy.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04906993","url":"https://clinicaltrials.gov/study/NCT04906993"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["camrelizumab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04906993","phase":"3","setting":"A Randomized, Open-Label, Controlled, Multi-Center Phase III Clinical Study of Camrelizumab Combined With Famitinib Malate Versus Platinum-based Chemotherapy in the Treatment of Recurrent/Metastatic Cervical Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2021-07-23","startedType":"actual","enrolled":443,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07107217","kind":"trial","name":"Camrelizumab in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-negative Breast Cancer","aka":["Camella"],"tldr":"A phase 2 trial of camrelizumab, doxorubicin, cyclophosphamide, carboplatin and other drugs in triple-negative breast cancer, run by Blokhin's Russian Cancer Research Center, not yet recruiting.","summary":"Camrelizumab in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-negative Breast Cancer is a phase 2, interventional study registered as NCT07107217 by Blokhin's Russian Cancer Research Center, with a registry enrolment figure of 40 participants, started 2025-08 and due to reach its primary completion in 2026-12. Interventions recorded: Camrelizumab; Doxorubicin +cyclophosphamide+ filgrastimum; carboplatin + paclitaxel (CP). Conditions listed: Breast Cancer. Triple-negative eligibility wording from the registry: \"1\\) 18-65 Years, female; 2) Histologically documented Triple Negative Breast Cancer (TNBC) patients; 3) Previously untreated non-metastatic (M0) TNBC, T3-4NanyM0 или TanyN+M0 3) Promising radical surgical treatment; 4) At least one measurable lesion according to RECIST 1\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07107217","url":"https://clinicaltrials.gov/study/NCT07107217"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["camrelizumab","doxorubicin","cyclophosphamide","carboplatin","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07107217","phase":"2","setting":"Camrelizumab in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-negative Breast Cancer","sponsor":"Blokhin's Russian Cancer Research Center","started":"2025-08","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05451290","kind":"trial","name":"Camrelizumab Plus Apatinib in Combination With GEMOX (Gemcitabine and Oxaliplatin ) in Patients With Locally Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of camrelizumab, gemcitabine, oxaliplatin and S-1 in gallbladder cancer and other biliary tract cancers, run by First Affiliated Hospital of Zhejiang University, active and no longer recruiting.","summary":"Camrelizumab Plus Apatinib in Combination With GEMOX (Gemcitabine and Oxaliplatin ) in Patients With Locally Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT05451290 by First Affiliated Hospital of Zhejiang University, with a registry enrolment figure of 30 participants, started 2022-11-01 and due to reach its primary completion in 2024-12-31. Interventions recorded: Camrelizumab, apatinib, gemcitabine, oxaliplatin, tegafur. Conditions listed: Advanced Biliary Tract Carcinoma. Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05451290","url":"https://clinicaltrials.gov/study/NCT05451290"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["camrelizumab","gemcitabine","oxaliplatin","tegafur-gimeracil-oteracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05451290","phase":"2","setting":"Camrelizumab Plus Apatinib Combined With GEMOX (Gemcitabine and Oxaliplatin ) in the Perioperative Treatment of Locally Advanced Biliary Tract Malignancies: A Prospective, Multicenter, Phase Ⅱ Study","sponsor":"First Affiliated Hospital of Zhejiang University","started":"2022-11-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07161791","kind":"trial","name":"Camrelizumab, Pirfenidone, and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 1/2 trial in triple-negative breast cancer, run by Harbin Medical University, not yet recruiting.","summary":"Camrelizumab, Pirfenidone, and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer is a phase 1/2, interventional study registered as NCT07161791 by Harbin Medical University, with a registry enrolment figure of 12 participants, started 2025-09-15 and due to reach its primary completion in 2026-12-31. Interventions recorded: Camrelizumab Combined With Pirfenidone and Chemotherapy. Conditions listed: Breast Cancer; Triple Negative Breast Cancer (TNBC). Triple-negative eligibility wording from the registry: \"* Histologically confirmed recurrent/metastatic TNBC (ER-negative: IHC ER \\<1%; PR-negative: IHC PR \\<1%; HER2-negative: IHC -/+, or IHC ++ but FISH/CISH negative), with at least one measurable lesion per RECIST v1\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07161791","url":"https://clinicaltrials.gov/study/NCT07161791"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07161791","phase":"1/2","setting":"Exploratory Clinical Study of Camrelizumab Combined With Pirfenidone and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer","sponsor":"Harbin Medical University","started":"2025-09-15","startedType":"estimated","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02945566","kind":"trial","name":"Can we Save the Rectum by Watchful Waiting or TransAnal Surgery Following (Chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer?","aka":["STAR-TREC"],"tldr":"A phase 2/3 trial of capecitabine in colorectal cancer, run by University of Birmingham, active but no longer recruiting.","summary":"Can we Save the Rectum by Watchful Waiting or TransAnal Surgery Following (Chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer? is a phase 2/3, randomised interventional study registered as NCT02945566 by University of Birmingham, with a registry enrolment figure of 380 participants, started 2017-06-14 and due to reach its primary completion in 2027-08. Interventions recorded: Standard TME surgery; Long course concurrent chemoradiation with capecitabine and radiotherapy; Short course radiotherapy. Conditions listed: Adenocarcinoma of the Rectum. Primary outcome: Phase II (Feasibility study) Primary Outcome: Recruitment Rate; Phase III Primary Outcome: Organ Preservation. Colorectal eligibility wording from the registry: \"* Biopsy proven adenocarcinoma of the rectum\". Sites: Belgium, Denmark, Netherlands, Sweden, United Kingdom. United Kingdom sites listed: 1. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02945566","url":"https://clinicaltrials.gov/study/NCT02945566"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): University of Birmingham (Birmingham)."],"nct":"NCT02945566","phase":"2/3","setting":"STAR-TREC: Can we Save the Rectum by Watchful Waiting or TransAnal Surgery Following (Chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer?","sponsor":"University of Birmingham","started":"2017-06-14","startedType":"actual","enrolled":380,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04495153","kind":"trial","name":"CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC","aka":[],"tldr":"A phase 2 trial of Aglatimagene besadenovec in non-small-cell lung cancer and small-cell lung cancer, run by Candel Therapeutics, Inc., active and no longer recruiting.","summary":"CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC is a phase 2 interventional study registered as NCT04495153 by Candel Therapeutics, Inc., with 90 participants enrolled, started 2020-10-13 and due to reach its primary completion in 2024-12-31. Interventions recorded: Aglatimagene besadenovec. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04495153","url":"https://clinicaltrials.gov/study/NCT04495153"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["aglatimagene-besadenovec"],"companies":["candel-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04495153","phase":"2","setting":"CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC Patients","sponsor":"Candel Therapeutics, Inc.","started":"2020-10-13","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03949283","kind":"trial","name":"Cancer Stem Cell Assay Directed Chemotherapy in Recurrent Platinum Resistant Ovarian Cancer","aka":[],"tldr":"A phase 3 trial of Standard Chemotherapy in ovarian cancer, run by Cordgenics, LLC, active and no longer recruiting.","summary":"Cancer Stem Cell Assay Directed Chemotherapy in Recurrent Platinum Resistant Ovarian Cancer is a phase 3 interventional study registered as NCT03949283 by Cordgenics, LLC, with 150 participants enrolled, started 2019-07-26 and due to reach its primary completion in 2024-06-30. Interventions recorded: Standard Chemotherapy.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03949283","url":"https://clinicaltrials.gov/study/NCT03949283"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03949283","phase":"3","setting":"Standard Chemotherapy Versus Cancer Stem Cell Assay Directed Chemotherapy in Recurrent Platinum Resistant Ovarian Cancer","sponsor":"Cordgenics, LLC","started":"2019-07-26","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05994001","kind":"trial","name":"Candonilimab in Combination With LM-302 for Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody","aka":[],"tldr":"A phase 1/2 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by Shanghai Zhongshan Hospital, active and no longer recruiting.","summary":"Candonilimab in Combination With LM-302 for Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody is a phase 1/2, randomised interventional study registered as NCT05994001 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 78 participants, started 2023-08-01 and due to reach its primary completion in 2026-05-01. Interventions recorded: cardonilizumab, LM-302. Conditions listed: Biliary Tract Cancer, Candonilimab, Claudin 18.2. Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05994001","url":"https://clinicaltrials.gov/study/NCT05994001"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05994001","phase":"1/2","setting":"Two Stage, Multi-center Trial of Candonilimab in Combination With LM-302 for Treatment of Patients With Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody","sponsor":"Shanghai Zhongshan Hospital","started":"2023-08-01","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"canstem111p","kind":"trial","name":"CanStem111P","aka":["CanStem 111P","BBI-608 pancreatic phase 3"],"tldr":"CanStem111P is the largest first-line pancreatic cancer trial ever run, 1,134 patients, and it found that the stemness inhibitor napabucasin added nothing to nab-paclitaxel and gemcitabine; the trial was stopped for futility and its control arm is now the best description of what that chemotherapy achieves.","summary":"Between January 2017 and February 2019, 1,779 patients were screened and 1,134 randomised (565 napabucasin, 569 control), 206 and 176 of them biomarker-positive. Median overall survival was 11.4 months (95 percent confidence interval 10.5 to 12.2) with napabucasin against 11.7 months (10.7 to 12.7) with chemotherapy alone (hazard ratio 1.07, 0.93 to 1.23), with no difference in the phospho-STAT3-positive subgroup, and the trial was terminated for futility. Grade 3 or worse adverse events occurred in 85.4 against 83.9 percent, with more gastrointestinal events on napabucasin (diarrhoea 11.6 against 4.9 percent; abdominal pain 10.0 against 4.8). The 11.7-month control-arm survival, higher than MPACT's 8.5 months, reflects fitter trial populations and better supportive care a decade on, and is the yardstick against which NAPOLI 3's 9.2-month control arm is often compared.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02993731","url":"https://clinicaltrials.gov/study/NCT02993731"},{"label":"Bekaii-Saab et al., CanStem111P (eClinicalMedicine 2023)","url":"https://doi.org/10.1016/j.eclinm.2023.101897"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["napabucasin","gemcitabine-nab-paclitaxel"],"companies":["sumitomo-pharma"],"institutions":[],"pathways":[],"terms":["pancreatic-failed-programmes"],"trials":[],"people":["tanios-bekaii-saab"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02993731","phase":"3","setting":"Untreated metastatic pancreatic adenocarcinoma at 165 sites in 20 countries: napabucasin with nab-paclitaxel plus gemcitabine against chemotherapy alone, open-label, adaptive, with overall survival as the primary endpoint and a phospho-STAT3 biomarker subgroup","sponsor":"Sumitomo Pharma Oncology (Boston Biomedical)","result":"Median overall survival 11.4 months with napabucasin plus nab-paclitaxel and gemcitabine against 11.7 months with chemotherapy alone (hazard ratio 1.07, 95 percent confidence interval 0.93 to 1.23); terminated for futility.","started":"2016-12","yearReported":2023,"enrolled":1134,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Napabucasin + nab-paclitaxel + gemcitabine","n":565,"value":11.4,"note":"95% CI 10.5 to 12.2"},{"name":"Nab-paclitaxel + gemcitabine","n":569,"value":11.7,"note":"95% CI 10.7 to 12.7"}],"hr":1.07,"ci":[0.93,1.23],"source":"https://doi.org/10.1016/j.eclinm.2023.101897"}]},{"id":"rejuv-trial-canwork","kind":"trial","name":"CanWork: an occupational therapy programme to help women return to work after breast cancer","aka":["CanWork","NCT06723899"],"tldr":"Return to work is one of the outcomes most affected by cancer treatment and least provided for. This cluster-randomised trial tests a five-module occupational therapy programme and costs it, so that a commissioner could act on the result.","summary":"The return-to-work record on this front sets out what is known and what is missing: trials of vocational rehabilitation exist, every one was in a high-income country, and none of the literature covers self-employment, which is the situation in which a cancer diagnosis most directly removes income. CanWork adds a trial with an economic analysis attached, which is the part that determines whether anything is commissioned.\n\nThe intervention is online and occupational-therapy led: five group-based modules of 90 minutes each, plus an individual meeting with the facilitating occupational therapist, aimed at managing the cancer-related symptoms that interfere with work and covering workplace entitlements. It was developed with women who had had breast cancer and with the services that support them, and was piloted in 2021. The comparator group receives the standard supportive care provided at their local community cancer support centre. Randomisation is by cluster and the outcomes assessor is blinded.\n\nThere are two primary outcomes at twelve months from enrolment: return to work as a self-reported yes or no, which the investigators note a systematic review identified as the most commonly used work-related measure, and the ten-item return-to-work self-efficacy questionnaire. The registry states that the costs of running and attending the intervention will be calculated, and that the team intends to work with Irish cancer services on national availability if it is effective.\n\nThe registry records no phase for this study, as it tests a behavioural intervention rather than a drug; it is filed here as phase 3 because OnCo's schema has no value for an unphased randomised trial. Registry dates, read on 2 October 2026: start 13 November 2024 (actual), primary completion 30 September 2027 (estimated), completion 31 March 2028 (estimated). Enrolment of 248 is the registry's estimate.","status":"recruiting","asOf":"2026-10-02","links":[{"label":"ClinicalTrials.gov NCT06723899","url":"https://clinicaltrials.gov/study/NCT06723899"}],"tags":["rejuvenation","survivorship","open-problem","return-to-work","rehabilitation"],"related":["rejuv-life-return-to-work","rejuv-life-employment-rights-uk","rejuv-life-money-after-treatment","rejuv-agenda-rehabilitation-not-commissioned","idea-rejuv-rehabilitation-prescription-at-discharge","idea-acc-return-to-work-rehabilitation","rejuvenation-roadmap"],"cancers":["breast-cancer"],"sections":["rejuvenation","supportive-care"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06723899","phase":"3","setting":"Women aged 18 to 70 with breast cancer, community cancer support centres, Ireland","sponsor":"Trinity College Dublin, with the National Cancer Control Programme Ireland, the Royal College of Surgeons in Ireland and the University of Galway","started":"2024-11-13","startedType":"actual","enrolled":248,"enrolledBasis":"registry","outcomes":[]},{"id":"cao-aro-aio-12","kind":"trial","name":"CAO/ARO/AIO-12","aka":[],"tldr":"A German trial that tested whether chemotherapy should come before or after chemoradiotherapy. Afterwards gave more complete responses, which matters for keeping the rectum.","summary":"CAO/ARO/AIO-12 randomised 311 patients (306 evaluable) with locally advanced rectal cancer to chemoradiotherapy preceded by three cycles of FOLFOX (group A, induction) or followed by three cycles (group B, consolidation). Pathological complete response in the intention-to-treat population was 17 percent in group A and 25 percent in group B; only group B met the predefined statistical hypothesis. Compliance with chemoradiotherapy was better in group B and compliance with chemotherapy better in group A, and the longer interval to surgery in group B (median 90 against 45 days) did not increase surgical morbidity. The result is why consolidation chemotherapy, not induction, is the sequence used when organ preservation is the aim, the same conclusion OPRA reached for watch and wait.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02363374","url":"https://clinicaltrials.gov/study/NCT02363374"},{"label":"CAO/ARO/AIO-12: chemoradiotherapy plus induction or consolidation chemotherapy as total neoadjuvant therapy (Journal of Clinical Oncology 2019)","url":"https://doi.org/10.1200/JCO.19.00308"}],"tags":[],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["imrt-igrt","cytotoxic-chemotherapy"],"targets":[],"drugs":["folfox","fluorouracil","oxaliplatin"],"companies":[],"institutions":[],"pathways":[],"terms":["pcr","clinical-complete-response","chemoradiation"],"trials":["opra"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02363374","phase":"2","setting":"Locally advanced rectal cancer: chemoradiotherapy with induction chemotherapy before it, or consolidation chemotherapy after it","sponsor":"German Rectal Cancer Study Group (Claus Rödel)","result":"Pathological complete response 25 percent with consolidation chemotherapy against 17 percent with induction.","started":"2015-03-25","startedType":"actual","yearReported":2019,"enrolled":311,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathological complete response","primary":true,"unit":"percent","arms":[{"name":"Induction chemotherapy then chemoradiotherapy","n":156,"value":17},{"name":"Chemoradiotherapy then consolidation chemotherapy","n":150,"value":25}],"source":"https://doi.org/10.1200/JCO.19.00308"}],"replication":"OPRA found the same direction: consolidation chemotherapy gave higher TME-free survival than induction, 53 against 41 percent at three years and 54 against 39 percent at five."},{"id":"cao-aro-aio-94","kind":"trial","name":"CAO/ARO/AIO-94 (German Rectal Cancer Study)","aka":[],"tldr":"The German rectal trial moved chemoradiation to before surgery: local recurrence halved, more sphincters were saved and toxicity fell, with survival unchanged.","summary":"CAO/ARO/AIO-94 randomised 823 patients with clinical stage II or III rectal cancer to fluorouracil-based chemoradiation (50.4 Gy) given before or after total mesorectal excision. Five-year local recurrence was 6 percent with preoperative and 13 percent with postoperative treatment; acute and long-term toxicity were lower, and sphincter preservation in low tumours doubled, with no difference in overall survival (Sauer and colleagues, New England Journal of Medicine 2004). Preoperative chemoradiation became the standard for locally advanced rectal cancer.","status":"positive","asOf":"2026-09-17","links":[{"label":"NEJM 2004","url":"https://doi.org/10.1056/NEJMoa040694"},{"label":"CAO/ARO/AIO-94 at eleven years (Journal of Clinical Oncology 2012)","url":"https://doi.org/10.1200/JCO.2011.40.1836"}],"tags":["radiation-wave4"],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":["chemoradiation"],"trials":["rapido","prodige-23","stellar-rectal","stockholm-iii","dutch-tme-trial","cao-aro-aio-12"],"people":[],"bottlenecks":[],"keyPapers":["paper-sauer-preoperative-chemoradiotherapy-rectal-nejm-2004"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Locally advanced rectal cancer: preoperative versus postoperative fluorouracil chemoradiation","sponsor":"German Rectal Cancer Study Group","result":"5-year local recurrence 6% (preoperative) vs 13% (postoperative); overall survival unchanged.","yearReported":2004,"enrolled":823,"enrolledBasis":"registry","outcomes":[{"endpoint":"Local recurrence at 5 years","primary":true,"unit":"%","arms":[{"name":"Preoperative chemoradiation","n":421,"value":6},{"name":"Postoperative chemoradiation","n":402,"value":13}]}],"replication":"Confirmed at eleven years: local recurrence 7.1 against 10.1 percent (p=0.048), with no difference in overall survival or distant metastases."},{"id":"nct00602082","kind":"trial","name":"Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors","aka":[],"tldr":"A phase 2 trial of Capecitabine, Cisplatin and Streptozocin in Pancreatic neuroendocrine tumours, run by Cambridge University Hospitals NHS Foundation Trust, completed.","summary":"Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors is a phase 2 interventional study registered as NCT00602082 by Cambridge University Hospitals NHS Foundation Trust, with 84 participants recorded, started 2005-08 and reaching its primary completion in 2009-12. Interventions recorded: capecitabine, cisplatin, streptozocin, DNA analysis, RNA analysis, protein analysis, proteomic profiling, laboratory biomarker analysis. Conditions recorded: Gastrointestinal Carcinoid Tumor, Islet Cell Tumor.\n\nLinked to the drug Streptozocin because the registry names it among its interventions and Pancreatic neuroendocrine tumours among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00602082","url":"https://clinicaltrials.gov/study/NCT00602082"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic-net"],"sections":[],"technologies":[],"targets":[],"drugs":["capecitabine","cisplatin","streptozocin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00602082","phase":"2","setting":"A Randomised Phase II Study Comparing Capecitabine Plus Streptozocin With or Without Cisplatin Chemotherapy as Treatment for Unresectable or Metastatic Neuroendocrine Tumors","sponsor":"Cambridge University Hospitals NHS Foundation Trust","started":"2005-08","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06787339","kind":"trial","name":"Capecitabine in Low Risk Triple Negative Breast Cancer","aka":["Calorite"],"tldr":"A phase 2 trial of capecitabine in triple-negative breast cancer, run by Fudan University, not yet recruiting.","summary":"Capecitabine in Low Risk Triple Negative Breast Cancer is a phase 2, interventional study registered as NCT06787339 by Fudan University, with a registry enrolment figure of 198 participants, started 2025-01-15 and due to reach its primary completion in 2028-12-31. Interventions recorded: Capecitabine. Conditions listed: Breast Cancer. Triple-negative eligibility wording from the registry: \"Histologically documented TNBC after early breast cancer surgery (absence of HER2, ER, and PR expression)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06787339","url":"https://clinicaltrials.gov/study/NCT06787339"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06787339","phase":"2","setting":"A Prospective, Single-arm,Clinical Trial Exploring the Efficacy and Safety of Chemotherapy De-escalation Using Capecitabine in Low-risk Early Triple-negative Breast Cancer","sponsor":"Fudan University","started":"2025-01-15","startedType":"estimated","enrolled":198,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05973864","kind":"trial","name":"Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery","aka":["CAPPA"],"tldr":"A phase 2 trial of pembrolizumab and capecitabine in triple-negative breast cancer, run by UNICANCER, now recruiting.","summary":"Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery is a phase 2, interventional study registered as NCT05973864 by UNICANCER, with a registry enrolment figure of 220 participants, started 2025-03-11 and due to reach its primary completion in 2028-08. Interventions recorded: Pembrolizumab injection; Capecitabine tablets; Local radiotherapy. Conditions listed: Triple Negative Breast Neoplasms. Triple-negative eligibility wording from the registry: \"Histologically proven TNBC defined as follows:\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05973864","url":"https://clinicaltrials.gov/study/NCT05973864"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["pembrolizumab","capecitabine"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05973864","phase":"2","setting":"A Phase II Study to Evaluate CAPecitabine Plus Pembrolizumab as Post-operative Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Chemo-immunotherapy","sponsor":"UNICANCER","started":"2025-03-11","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07281768","kind":"trial","name":"Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin), capecitabine, cemiplimab, fianlimab and other drugs in colorectal cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, now recruiting.","summary":"Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT07281768 by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, with a registry enrolment figure of 66 participants, started 2026-07-14 and due to reach its primary completion in 2030-07. Interventions recorded: Oxaliplatin; Capecitabine; Cemiplimab; Fianlimab; REGN7075. Conditions listed: Colorectal Cancer. Primary outcome: Pathologic complete response (pCR) rate. Colorectal eligibility wording from the registry: \"* Rectal cancer (with tumor tissue present at or below the peritoneal reflection) as determined by MRI pelvis or endoscopic ultrasound\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07281768","url":"https://clinicaltrials.gov/study/NCT07281768"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","capecitabine","cemiplimab","fianlimab","regn7075"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07281768","phase":"2","setting":"Combining Capecitabine/Oxaliplatin Chemotherapy With Cemiplimab Alone or in Combination With Fianlimab or REGN7075 for the Neoadjuvant Treatment of Locally Advanced Rectal Cancer","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","started":"2026-07-14","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06881537","kind":"trial","name":"CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Locally Recurrent Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of capecitabine, fOLFOX (5-FU, leucovorin, oxaliplatin), bevacizumab (glioblastoma use) and tislelizumab in colorectal cancer, run by Shanghai Changzheng Hospital, now recruiting.","summary":"CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Locally Recurrent Colorectal Cancer is a phase 2, interventional study registered as NCT06881537 by Shanghai Changzheng Hospital, with a registry enrolment figure of 15 participants, started 2024-06-01 and due to reach its primary completion in 2025-06-30. Interventions recorded: Capecitabine; Oxaliplatin; Bevacizumab; Tislelizumab. Conditions listed: Locally Recurrent Colorectal Cancer. Primary outcome: Objective response rate; R0 resection rate; Pathological complete response rate. Colorectal eligibility wording from the registry: \"* Primary colorectal cancer underwent radical surgery, histologically confirmed as adenocarcinoma and achieved R0 resection, and postoperative adjuvant chemotherapy with Xelox or other first-line standard regimens\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06881537","url":"https://clinicaltrials.gov/study/NCT06881537"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["capecitabine","folfox","bevacizumab-glioma","tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06881537","phase":"2","setting":"CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Locally Recurrent Colorectal Cancer","sponsor":"Shanghai Changzheng Hospital","started":"2024-06-01","startedType":"actual","enrolled":15,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05699746","kind":"trial","name":"CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD","aka":[],"tldr":"A phase 3 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Zhejiang University, not yet recruiting.","summary":"CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD is a phase 3, randomised interventional study registered as NCT05699746 by Zhejiang University, with a registry enrolment figure of 38 participants, started 2023-03 and due to reach its primary completion in 2026-09. Interventions recorded: Capecitabine tablets; Oxaliplatin. Conditions listed: Colorectal Cancer. Primary outcome: Recurrence-free survival. Colorectal eligibility wording from the registry: \"Colorectal cancer confirmed by pathology, and the TNM stage (AJCC v8) is stage I or stage II\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05699746","url":"https://clinicaltrials.gov/study/NCT05699746"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05699746","phase":"3","setting":"A Randomized Controlled Trial of CAPEOX vs Observation in Early-stage Colorectal Cancer Patients With Positive MRD After Curative Surgery","sponsor":"Zhejiang University","started":"2023-03","startedType":"estimated","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"capitello-281","kind":"trial","name":"CAPItello-281","aka":[],"tldr":"CAPItello-281 delivered the first AKT inhibitor success in prostate cancer, for the ~25% of men whose tumours have lost PTEN on the trial's own immunohistochemistry cut-off.","summary":"CAPItello-281, trial NCT04493853 sponsored by AstraZeneca and reported in 2025, delivered the first AKT inhibitor success in prostate cancer, for the roughly quarter of men whose tumours have lost PTEN on its own immunohistochemistry cut-off, 1,519 of 6,003 tested. It randomised 1,012 men with de novo metastatic hormone-sensitive, PTEN-deficient prostate cancer to abiraterone with capivasertib or placebo, met its primary radiographic progression-free survival endpoint with topline results in November 2024 presented in 2025, and led to FDA approval in the second quarter of 2026, with diarrhoea, rash and raised blood sugar as the class effects. OnCo links it to AKT as a target, to the PI3K, AKT and mTOR pathway, and to capivasertib and abiraterone acetate. It is a single pivotal trial with immature overall survival, and whether the modest progression benefit justifies the added toxicity is the open question. Capivasertib has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT04493853","url":"https://clinicaltrials.gov/study/NCT04493853"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":["akt"],"drugs":["capivasertib","abiraterone"],"companies":["astrazeneca"],"institutions":[],"pathways":["pi3k-akt-mtor"],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-capitello-281-ann-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04493853","phase":"3","setting":"De novo metastatic hormone-sensitive prostate cancer with PTEN deficiency: abiraterone + capivasertib vs abiraterone + placebo","sponsor":"AstraZeneca","result":"Median rPFS 33.2 against 25.7 months, HR 0.81 (95% CI 0.66 to 0.98, p=0.034); OS HR 0.90 at 26.4% maturity; approved 2026.","started":"2020-07-13","startedType":"actual","yearReported":2025,"enrolled":1012,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic progression-free survival, PTEN-deficient mHSPC","primary":true,"unit":"months","arms":[{"name":"Capivasertib + abiraterone + ADT","value":40},{"name":"Placebo + abiraterone + ADT","value":31.7}],"hr":0.81,"ci":[0.68,0.96],"p":"0.017","source":"https://clinicaltrials.gov/study/NCT04493853"}],"replication":"Single pivotal trial; OS immature."},{"id":"capitello-291","kind":"trial","name":"CAPItello-291","aka":[],"tldr":"Adding the AKT inhibitor capivasertib to fulvestrant doubled progression-free time, especially in tumours with PI3K-pathway mutations.","summary":"CAPItello-291, trial NCT04305496 sponsored by AstraZeneca and reported in 2022, showed that adding the AKT inhibitor capivasertib to fulvestrant doubled progression-free time in HR-positive, HER2-negative advanced breast cancer after an aromatase inhibitor, with the largest effect in tumours carrying PIK3CA, AKT1 or PTEN alterations. It randomised 708 women, about seventy percent of whom had received CDK4/6 inhibitors, met its primary progression-free survival endpoints in both the overall and the altered populations, and led to a 2023 FDA label restricted to the altered population, with diarrhoea, rash and hyperglycaemia as the main toxicities. OnCo links it to AKT and PIK3CA as targets, capivasertib, fulvestrant and Nicholas Turner. Final overall survival is awaited, and whether unaltered tumours benefit enough to widen the label is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04305496","url":"https://clinicaltrials.gov/study/NCT04305496"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":["akt","pik3ca"],"drugs":["capivasertib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["nicholas-turner"],"bottlenecks":[],"keyPapers":["paper-capitello-291-nejm-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04305496","phase":"3","setting":"HR+/HER2- advanced breast cancer after aromatase inhibitor (± CDK4/6): capivasertib + fulvestrant vs placebo + fulvestrant","sponsor":"AstraZeneca","result":"PFS HR 0.60 overall; HR 0.50 in AKT-pathway-altered.","started":"2020-04-16","startedType":"actual","yearReported":2022,"enrolled":708,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 818 participants (actual); the NEJM 2023 primary analysis randomised 708 patients.","outcomes":[{"endpoint":"Progression-free survival (overall)","primary":true,"unit":"months","arms":[{"name":"Capivasertib + fulvestrant","n":355,"value":7.2},{"name":"Placebo + fulvestrant","n":353,"value":3.6}],"hr":0.6,"ci":[0.51,0.71],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2214131"},{"endpoint":"Progression-free survival (AKT-pathway-altered)","primary":true,"unit":"months","arms":[{"name":"Capivasertib + fulvestrant","n":155,"value":7.3},{"name":"Placebo + fulvestrant","n":134,"value":3.1}],"hr":0.5,"ci":[0.38,0.65],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa2214131"}],"replication":"Consistent with the phase 2 FAKTION trial (capivasertib + fulvestrant, PFS and OS benefit). Final OS from CAPItello-291 awaited."},{"id":"nct04862663","kind":"trial","name":"Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)","aka":["CAPItello-292"],"tldr":"A phase 3 trial of Capivasertib, Fulvestrant, Palbociclib, Ribociclib and Abemaciclib in advanced solid tumours, run by AstraZeneca, active and no longer recruiting.","summary":"Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) is a phase 3 interventional study registered as NCT04862663 by AstraZeneca, with 893 participants enrolled, started 2021-05-10 and due to reach its primary completion in 2027-11-01. Interventions recorded: Capivasertib, Fulvestrant, Palbociclib, Ribociclib and Abemaciclib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04862663","url":"https://clinicaltrials.gov/study/NCT04862663"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy","kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["capivasertib","fulvestrant","palbociclib","ribociclib","abemaciclib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04862663","phase":"3","setting":"A Phase Ib/III, Open-label, Randomised Study of Capivasertib Plus CDK4/6 Inhibitors and Fulvestrant Versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)","sponsor":"AstraZeneca","started":"2021-05-10","startedType":"actual","enrolled":893,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06635447","kind":"trial","name":"Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients","aka":["CAPItrue"],"tldr":"A phase 3 trial of Capivasertib and Fulvestrant in advanced solid tumours, run by AstraZeneca, active and no longer recruiting.","summary":"Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients is a phase 3 interventional study registered as NCT06635447 by AstraZeneca, with 293 participants enrolled, started 2024-09-26 and due to reach its primary completion in 2026-10-31. Interventions recorded: Capivasertib and Fulvestrant.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06635447","url":"https://clinicaltrials.gov/study/NCT06635447"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy","kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["capivasertib","fulvestrant"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06635447","phase":"3","setting":"A Phase IIIb Single Arm, 2 Cohorts Study Assessing the Efficacy and Safety of Capivasertib+ Fulvestrant as Treatment for Locally Advanced(Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With Endocrine Therapy in Chinese Patients","sponsor":"AstraZeneca","started":"2024-09-26","startedType":"actual","enrolled":293,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03997123","kind":"trial","name":"Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC","aka":["CAPItello-290"],"tldr":"A phase 3 trial of Capivasertib in triple-negative breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC is a phase 3 interventional study registered as NCT03997123 by AstraZeneca, with 923 participants enrolled, started 2019-06-25 and due to reach its primary completion in 2026-03-16. Interventions recorded: Capivasertib, Paclitaxel and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03997123","url":"https://clinicaltrials.gov/study/NCT03997123"},{"label":"CAPItello-290 (Annals of Oncology 2026)","url":"https://doi.org/10.1016/j.annonc.2025.12.012"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["capivasertib","paclitaxel"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["pik3ca","pten"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Primary paper (Annals of Oncology 2026): 812 untreated metastatic patients randomised July 2019 to February 2022 to paclitaxel 80 mg/m2 with capivasertib 400 mg or placebo twice daily on days 2 to 5 of weeks 1 to 3; 30.7 percent had PIK3CA, AKT1 or PTEN alterations. Neither overall survival endpoint met its boundary; grade 3 or higher diarrhoea 12.7 versus 0.7 percent; adverse events led to death in 4.2 percent. UK sites (registry, 7): Edinburgh, London (3), Sheffield, Surrey, York. NICE appraisal GID-TA11411 discontinued."],"nct":"NCT03997123","phase":"3","setting":"A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.","sponsor":"AstraZeneca","result":"Overall survival 17.7 vs 18.0 months (HR 0.92, p 0.32) overall and 20.4 vs 20.4 months (HR 1.05) in PIK3CA/AKT1/PTEN-altered tumours; PFS 5.6 vs 5.1 months (HR 0.72).","started":"2019-06-25","startedType":"actual","yearReported":2026,"enrolled":923,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 923 participants (actual); the Annals of Oncology 2026 primary paper covers 812 randomised patients.","outcomes":[{"endpoint":"Overall survival, all patients","primary":true,"unit":"months","arms":[{"name":"Capivasertib + paclitaxel","value":17.7},{"name":"Placebo + paclitaxel","value":18}],"hr":0.92,"ci":[0.78,1.08],"p":"0.3239","source":"https://doi.org/10.1016/j.annonc.2025.12.012"},{"endpoint":"Overall survival, PIK3CA/AKT1/PTEN-altered tumours","primary":true,"unit":"months","arms":[{"name":"Capivasertib + paclitaxel","value":20.4},{"name":"Placebo + paclitaxel","value":20.4}],"hr":1.05,"ci":[0.77,1.43],"p":"0.7602","source":"https://doi.org/10.1016/j.annonc.2025.12.012"},{"endpoint":"Progression-free survival (investigator), all patients","unit":"months","arms":[{"name":"Capivasertib + paclitaxel","value":5.6},{"name":"Placebo + paclitaxel","value":5.1}],"hr":0.72,"ci":[0.61,0.84],"source":"https://doi.org/10.1016/j.annonc.2025.12.012"}]},{"id":"nct07383285","kind":"trial","name":"CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab as First-line Treatment for RAS-Mutant/MSS Metastatic Rectal C","aka":[],"tldr":"A phase 2 trial of iparomlimab and tuvonralimab, capecitabine, bevacizumab (glioblastoma use) and oxaliplatin in colorectal cancer, run by Peking University Cancer Hospital & Institute, not yet recruiting.","summary":"CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab as First-line Treatment for RAS-Mutant/MSS Metastatic Rectal Cancer is a phase 2, randomised interventional study registered as NCT07383285 by Peking University Cancer Hospital & Institute, with a registry enrolment figure of 106 participants, started 2026-02-01 and due to reach its primary completion in 2029-12-31. Interventions recorded: Iparomlimab and Tuvonralimab; Radiotherapy to the primary site; Capecitabine; Bevacizumab; Oxaliplatin injection. Conditions listed: Rectal Neoplasms Malignant. Primary outcome: 12-month disease-free survival rate (progression-free survival rate, PFSR). Colorectal eligibility wording from the registry: \"Pathological tissue diagnosis confirmed rectal adenocarcinoma (including signet ring cell carcinoma and mucinous adenocarcinoma);\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07383285","url":"https://clinicaltrials.gov/study/NCT07383285"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["iparomlimab-tuvonralimab","capecitabine","bevacizumab-glioma","oxaliplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07383285","phase":"2","setting":"CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab as First-line Treatment for RAS-Mutant/MSS Metastatic Rectal Cancer: An Open-label, Randomized, Multi-center Phase II Study","sponsor":"Peking University Cancer Hospital & Institute","started":"2026-02-01","startedType":"estimated","enrolled":106,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06281405","kind":"trial","name":"CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer","aka":["TORCH-iTNT"],"tldr":"A phase 2 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Fudan University, now recruiting.","summary":"CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT06281405 by Fudan University, with a registry enrolment figure of 192 participants, started 2024-03-28 and due to reach its primary completion in 2026-06-30. Interventions recorded: PD-1 inhibitor; Capecitabine; Short-course radiotherapy; Oxaliplatin. Conditions listed: Locally Advanced Rectal Cancer; Neoadjuvant Therapy. Primary outcome: Complete response (CR) rate. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06281405","url":"https://clinicaltrials.gov/study/NCT06281405"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06281405","phase":"2","setting":"A Prospective Randomized Phase II Trial of CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for Microsatellite Stable Locally Advanced Rectal Cancer (TORCH-iTNT)","sponsor":"Fudan University","started":"2024-03-28","startedType":"actual","enrolled":192,"enrolledBasis":"registry","outcomes":[]},{"id":"capp2","kind":"trial","name":"CAPP2","aka":["CAPP 2","Colorectal Adenoma/Carcinoma Prevention Programme 2"],"tldr":"CAPP2 followed people with Lynch syndrome, an inherited condition that carries a very high risk of bowel cancer, for ten years after two to four years on aspirin or placebo: those who took aspirin developed about a third fewer bowel cancers, which is why daily aspirin is now offered to people with the syndrome.","summary":"CAPP2 was a double-blind randomised placebo-controlled trial in which 861 carriers of Lynch syndrome from 43 international centres were assigned to 600 mg aspirin daily or placebo, with treatment lasting a mean of 25 months, and cancer outcomes followed for at least ten years (up to 20 years through registries in England, Finland and Wales). The primary endpoint was colorectal cancer.\n\nOver a mean of ten years, 40 of 427 aspirin participants (9 percent) developed colorectal cancer against 58 of 434 on placebo (13 percent), a hazard ratio of 0.65 by intention to treat and 0.56 among those who completed two years of treatment. Non-colorectal Lynch cancers were not significantly reduced and adverse events during treatment did not differ. The trial is the evidence for daily aspirin in Lynch syndrome on the corpus's mismatch-repair-deficient colorectal cancer page, and the CaPP3 dose-finding trial followed it.","status":"positive","asOf":"2026-09-22","links":[{"label":"ISRCTN59521990","url":"https://www.isrctn.com/ISRCTN59521990"}],"tags":["soc-trials"],"related":[],"cancers":["msi-high-colorectal"],"sections":[],"technologies":["aspirin-cancer-prevention"],"targets":[],"drugs":["aspirin"],"companies":[],"institutions":["newcastle-cancer-centre"],"pathways":[],"terms":[],"trials":[],"people":["john-burn"],"bottlenecks":[],"keyPapers":["paper-capp2-aspirin-lynch-lancet-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN59521990","phase":"3","setting":"People with Lynch syndrome at 43 centres worldwide: 600 mg aspirin daily or placebo for up to four years (a resistant starch factorial arm was reported separately), with colorectal cancer as the primary endpoint over a planned ten years of follow-up","sponsor":"Newcastle University (CAPP2 Investigators)","result":"Colorectal cancer in 9 percent of participants on aspirin against 13 percent on placebo over ten years (hazard ratio 0.65, p 0.035); hazard ratio 0.56 among those who completed two years of treatment.","yearReported":2020,"enrolled":861,"enrolledBasis":"randomised","enrolledNote":"CAPP2 has no ClinicalTrials.gov record; the figure is the 861 participants randomised in the Lancet 2020 report (427 aspirin, 434 placebo) of 937 who started treatment; the trial is registered as ISRCTN59521990.","outcomes":[{"endpoint":"Colorectal cancer over a mean of 10 years of follow-up (intention to treat)","primary":true,"unit":"%","arms":[{"name":"Aspirin 600 mg daily","n":427,"value":9,"note":"40 cases"},{"name":"Placebo","n":434,"value":13,"note":"58 cases"}],"hr":0.65,"ci":[0.43,0.97],"p":"0.035","source":"https://doi.org/10.1016/S0140-6736(20)30366-4"},{"endpoint":"Colorectal cancer, per protocol (at least 2 years of treatment)","unit":"%","arms":[{"name":"Aspirin 600 mg daily","note":"509 participants across both arms completed 2 years"},{"name":"Placebo"}],"hr":0.56,"ci":[0.34,0.91],"p":"0.019","source":"https://doi.org/10.1016/S0140-6736(20)30366-4"},{"endpoint":"Incidence rate ratio for colorectal cancer accounting for multiple primaries (intention to treat)","arms":[{"name":"Aspirin 600 mg daily","value":0.58,"note":"95% CI 0.39 to 0.87, p 0.0085"},{"name":"Placebo","value":1}],"source":"https://doi.org/10.1016/S0140-6736(20)30366-4"}]},{"id":"capstone-1","kind":"trial","name":"CAPSTONE-1","aka":[],"tldr":"The trial that added Hengrui's PD-L1 antibody adebrelimab to chemotherapy for small cell lung cancer, with one of the larger survival gains seen in that disease.","summary":"462 patients, double blind. Median overall survival 15.3 versus 12.8 months (hazard ratio 0.72); two-year survival 31.3% versus 17.2%. NMPA approval March 2023. Together with ASTRUM-005 (serplulimab) it shows Chinese PD-(L)1 antibodies matching or exceeding the IMpower133 and CASPIAN benchmarks in a Chinese population.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03711305","url":"https://clinicaltrials.gov/study/NCT03711305"},{"label":"Lancet Oncol 2022","url":"https://doi.org/10.1016/S1470-2045(22)00224-8"}],"tags":["china"],"related":["astrum-005","impower133","caspian"],"cancers":["sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab","carboplatin","etoposide"],"companies":["hengrui"],"institutions":["jilin-cancer-hospital"],"pathways":[],"terms":[],"trials":[],"people":["cheng-ying"],"bottlenecks":[],"keyPapers":["paper-capstone-1-lancet-oncol-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03711305","phase":"3","setting":"First-line extensive-stage small cell lung cancer, China: adebrelimab or placebo plus carboplatin and etoposide","sponsor":"Jiangsu Hengrui Pharmaceuticals","result":"OS 15.3 vs 12.8 months, HR 0.72.","started":"2018-12-30","startedType":"actual","yearReported":2022,"enrolled":462,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Adebrelimab + EC","n":230,"value":15.3},{"name":"Placebo + EC","n":232,"value":12.8}],"hr":0.72,"source":"https://doi.org/10.1016/S1470-2045(22)00224-8"}]},{"id":"captain-1st","kind":"trial","name":"CAPTAIN-1st","aka":[],"tldr":"CAPTAIN-1st showed that adding the PD-1 antibody camrelizumab to gemcitabine and cisplatin kept advanced nasopharyngeal cancer under control for about three months longer, confirming with a second drug what JUPITER-02 found with toripalimab.","summary":"CAPTAIN-1st randomised 263 patients with untreated recurrent or metastatic nasopharyngeal carcinoma at 28 Chinese centres to camrelizumab or placebo with gemcitabine and cisplatin for up to six cycles, followed by camrelizumab or placebo maintenance. Gemcitabine-cisplatin had been the standard since the 2016 GEM20110714 trial.\n\nReported by Yunpeng Yang and Li Zhang in Lancet Oncology in 2021, median progression-free survival was 9.7 months with camrelizumab against 6.9 months with placebo (hazard ratio 0.54). Camrelizumab's characteristic reactive capillary haemangiomas were the main additional toxicity.\n\nWith JUPITER-02 (toripalimab) and RATIONALE-309 (tislelizumab), it made PD-1 blockade with gemcitabine-cisplatin the first-line standard for advanced nasopharyngeal carcinoma in China and in the NCCN guideline; camrelizumab was approved for this use in China in 2021.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03707509","url":"https://clinicaltrials.gov/study/NCT03707509"}],"tags":[],"related":[],"cancers":["nasopharyngeal","head-and-neck","recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["camrelizumab","gemcitabine-cisplatin","gemcitabine","cisplatin"],"companies":["hengrui"],"institutions":["sysucc"],"pathways":[],"terms":[],"trials":["jupiter-02"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03707509","phase":"3","setting":"Untreated recurrent or metastatic nasopharyngeal carcinoma: camrelizumab or placebo with gemcitabine and cisplatin, then camrelizumab or placebo maintenance","sponsor":"Jiangsu Hengrui","result":"Median progression-free survival 9.7 vs 6.9 months (hazard ratio 0.54).","started":"2018-11-13","startedType":"actual","yearReported":2021,"enrolled":263,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Camrelizumab + gemcitabine-cisplatin","value":9.7},{"name":"Placebo + gemcitabine-cisplatin","value":6.9}],"hr":0.54}],"replication":"JUPITER-02 (toripalimab) and RATIONALE-309 (tislelizumab) reported the same effect with different PD-1 antibodies."},{"id":"captivate","kind":"trial","name":"CAPTIVATE","aka":[],"tldr":"Fifteen months of two pills, then stop: three-quarters of patients had no detectable leukaemia in the blood, and most remained in remission years later.","summary":"Fixed-duration cohort: CR 55% (primary endpoint met), uMRD in blood 77%, 4-year PFS ~79% (2024 update), retreatment with ibrutinib effective at relapse. MRD-guided cohort tested stopping vs continuing in confirmed uMRD (no PFS difference at 3 years). Blood 2022; JCO 2024. Basis (with GLOW) of the EU approval of fixed-duration ibrutinib-venetoclax.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02910583","url":"https://clinicaltrials.gov/study/NCT02910583"}],"tags":[],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["btk","bcl2"],"drugs":["ibrutinib","venetoclax"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":["mrd-negative-cr"],"trials":[],"people":["william-wierda"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02910583","phase":"2","setting":"Previously untreated CLL, age ≤70: 3 cycles ibrutinib lead-in then 12 cycles ibrutinib + venetoclax (fixed-duration cohort n=159; MRD-guided cohort n=164)","sponsor":"Pharmacyclics / AbbVie","result":"CR 55%; uMRD 77%; 4-year PFS ~79%.","started":"2016-09-28","startedType":"actual","yearReported":2021,"enrolled":323,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response (fixed-duration cohort)","primary":true,"unit":"%","arms":[{"name":"Ibrutinib + venetoclax","n":159,"value":55}],"source":"https://ashpublications.org/blood/article/139/22/3278/484118"},{"endpoint":"Undetectable MRD in peripheral blood","unit":"%","arms":[{"name":"Ibrutinib + venetoclax","value":77}],"source":"https://doi.org/10.1182/blood.2021014488"}],"replication":"GLOW (randomised, older/unfit) confirmed fixed-duration ibrutinib-venetoclax superiority over chemoimmunotherapy; AMPLIFY replicated the BTKi + venetoclax fixed-duration concept with acalabrutinib."},{"id":"nct06179524","kind":"trial","name":"CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/Refractory B-ALL","aka":[],"tldr":"A phase 2 trial of CAR-T-19 cell injection in acute lymphoblastic leukaemia, run by Beijing Yongtai Ruike Biotechnology Company Ltd, now recruiting.","summary":"CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/Refractory B-ALL is a phase 2 interventional study registered as NCT06179524 by Beijing Yongtai Ruike Biotechnology Company Ltd, with 100 participants planned, started 2024-01-03 and due to reach its primary completion in 2025-06-30. Interventions recorded: CAR-T-19 cell injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06179524","url":"https://clinicaltrials.gov/study/NCT06179524"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":[],"targets":["cd19"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06179524","phase":"2","setting":"Phase II Clinical Study of CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/refractory B-cell Acute Lymphoblastic Leukemia(B-ALL) Under 25 Years of Age (inclusive)","sponsor":"Beijing Yongtai Ruike Biotechnology Company Ltd","started":"2024-01-03","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07257523","kind":"trial","name":"Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Yonsei University, now recruiting.","summary":"Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer is a phase 2, interventional study registered as NCT07257523 by Yonsei University, with a registry enrolment figure of 33 participants, started 2025-09-23 and due to reach its primary completion in 2027-07. Interventions recorded: Carbon Ion Radiotherapy. Conditions listed: Pancreatic Neoplasm. Primary outcome: Overall survival in frail patients with pancreatic cancer receiving carbon ion radiotherapy. Pancreatic eligibility wording from the registry: \"\\- Histologically confirmed pancreatic cancer without distant metastasis\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07257523","url":"https://clinicaltrials.gov/study/NCT07257523"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07257523","phase":"2","setting":"Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer: A Prospective Phase II Study","sponsor":"Yonsei University","started":"2025-09-23","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07433283","kind":"trial","name":"Carbon Nanoparticle-Loaded Iron in the Treatment of Advanced Solid Tumor","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Sichuan Enray Pharmaceutical Sciences Company, now recruiting.","summary":"Carbon Nanoparticle-Loaded Iron in the Treatment of Advanced Solid Tumor is a phase 1/2, interventional study registered as NCT07433283 by Sichuan Enray Pharmaceutical Sciences Company, with a registry enrolment figure of 54 participants, started 2024-11-12 and due to reach its primary completion in 2026-12-31. Interventions recorded: Carbon Nanoparticle-Loaded Iron [CNSI-Fe]; Carbon Nanoparticle-Loaded Iron. Conditions listed: Tumor, Solid; Lung Cancer; Pancreas Cancer; Thyroid Cancer; Colorectal Cancer; Cervical Cancer; Vulva Cancer. Primary outcome: Incidence and severity of participants with treatment-related adverse events as assessed by CTCAE v5.0. Pancreatic eligibility wording from the registry: \"Stage Ib: patients with advanced solid tumors confirmed by histology or cytology, and the current standard therapy is ineffective (disease progression after treatment or treatment is not tolerated) or there is no effective standard treatment, such as soft tissue sarcoma, refractory thyroid cancer, c\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07433283","url":"https://clinicaltrials.gov/study/NCT07433283"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07433283","phase":"1/2","setting":"A Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of Intratumoral Injection of Carbon Nanoparticle-Loaded Iron Suspension Injection [CNSI-Fe(II)] With Multiple Administrations in Subjects With Advanced Solid Tumors","sponsor":"Sichuan Enray Pharmaceutical Sciences Company","started":"2024-11-12","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04296175","kind":"trial","name":"Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE)","aka":["CITRINE"],"tldr":"A phase 3 trial of epirubicin, paclitaxel / nab-paclitaxel and carboplatin in triple-negative breast cancer, run by Fudan University, active but no longer recruiting.","summary":"Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE) is a phase 3, randomised interventional study registered as NCT04296175 by Fudan University, with a registry enrolment figure of 808 participants, started 2020-03-05 and due to reach its primary completion in 2025-03-10. Interventions recorded: Epirubicin; CTX; Paclitaxel; ddEpirubicin; ddCTX; Paclitaxel(with carbo); Carboplatin. Conditions listed: Triple-negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Histologically documented TNBC after early breast cancer surgery (absence of HER2, ER, and PR expression)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04296175","url":"https://clinicaltrials.gov/study/NCT04296175"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["epirubicin","paclitaxel","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04296175","phase":"3","setting":"A Prospective, Single Center, Randomized, Open-labled Stage III Clinical Trial Comparing the Efficacy and Safety of Anthracyclin Followed by Weekly Paclitaxel Versus Dose-dense Anthracyclin Followed by Weekly Paclitaxel Versus Dose-dense Anthracyclin Followed by Weekly Paclitaxel Combined With Carboplatin for High-risk, Triple-negative Early Breast Cancer","sponsor":"Fudan University","started":"2020-03-05","startedType":"actual","enrolled":808,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07087054","kind":"trial","name":"Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen","aka":["CAREFNDR"],"tldr":"A phase 3 trial of Paltusotine in neuroendocrine tumours and pancreatic ductal adenocarcinoma, run by Crinetics Pharmaceuticals Inc., now recruiting.","summary":"Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen is a phase 3 interventional study registered as NCT07087054 by Crinetics Pharmaceuticals Inc., with 141 participants planned, started 2025-11-19 and due to reach its primary completion in 2027-08. Interventions recorded: Paltusotine and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07087054","url":"https://clinicaltrials.gov/study/NCT07087054"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine","pancreatic","small-intestinal-net"],"sections":[],"technologies":[],"targets":[],"drugs":["paltusotine"],"companies":["crinetics-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07087054","phase":"3","setting":"A Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults With Carcinoid Syndrome Due to Well-Differentiated Neuroendocrine Tumors","sponsor":"Crinetics Pharmaceuticals Inc.","started":"2025-11-19","startedType":"actual","enrolled":141,"enrolledBasis":"registry","outcomes":[]},{"id":"card","kind":"trial","name":"CARD","aka":["CARD","cabazitaxel against a second androgen receptor pathway inhibitor"],"tldr":"Settled the commonest argument in advanced prostate cancer. When one hormone tablet stops working quickly, switching to the other one is much worse than moving to chemotherapy.","summary":"By 2019 most men with castration-resistant prostate cancer were being offered abiraterone or enzalutamide, and when one failed, the other. CARD tested whether that switch is as good as chemotherapy.\n\nIt randomised 255 men who had received docetaxel and progressed within 12 months on abiraterone or enzalutamide to cabazitaxel 25 mg/m2 every 3 weeks with prednisone and granulocyte colony-stimulating factor, or to the other androgen receptor pathway inhibitor.\n\nAt a median 9.2 months, imaging-based progression or death had occurred in 95 of 129 men (73.6 percent) on cabazitaxel against 101 of 126 (80.2 percent) on the second inhibitor, hazard ratio 0.54 (95 percent confidence interval 0.40 to 0.73, p<0.001). Median imaging-based progression-free survival was 8.0 against 3.7 months. Median overall survival was 13.6 against 11.0 months, hazard ratio 0.64 (0.46 to 0.89, p=0.008). Progression-free survival was 4.4 against 2.7 months (0.52, 0.40 to 0.68, p<0.001), PSA response occurred in 35.7 against 13.5 percent (p<0.001) and tumour response in 36.5 against 11.5 percent (p=0.004).\n\nAdverse events of grade 3 or higher occurred in 56.3 percent on cabazitaxel and 52.4 percent on the second inhibitor, so the chemotherapy was not meaningfully more toxic in this population. CARD is the clearest evidence in prostate cancer that switching within a drug class after early failure is a waste of time.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02485691","url":"https://clinicaltrials.gov/study/NCT02485691"},{"label":"CARD (New England Journal of Medicine 2019)","url":"https://doi.org/10.1056/NEJMoa1911206"},{"label":"NICE TA391: cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel","url":"https://www.nice.org.uk/guidance/ta391"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["cytotoxic-chemotherapy","androgen-deprivation"],"targets":["androgen-receptor"],"drugs":["cabazitaxel","abiraterone","enzalutamide","prednisone"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":["arpi","castration-resistance","ar-v7"],"trials":["tropic","proselica","therap","vision"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02485691","phase":"3","setting":"Metastatic castration-resistant prostate cancer previously treated with docetaxel and with progression within 12 months on abiraterone or enzalutamide: cabazitaxel 25 mg/m2 every 3 weeks with prednisone and granulocyte colony-stimulating factor, against the other androgen receptor pathway inhibitor, with imaging-based progression-free survival as the primary endpoint","sponsor":"Sanofi","result":"Median imaging-based progression-free survival 8.0 against 3.7 months (hazard ratio 0.54, 95 percent confidence interval 0.40 to 0.73) and overall survival 13.6 against 11.0 months (0.64, 0.46 to 0.89) for cabazitaxel against a second androgen receptor pathway inhibitor.","started":"2015-11-09","startedType":"actual","yearReported":2019,"enrolled":255,"enrolledBasis":"randomised","enrolledNote":"255 men underwent randomisation; the trial was designed around this size because the effect it sought was large.","outcomes":[{"endpoint":"Imaging-based progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Cabazitaxel with prednisone","n":129,"value":8},{"name":"Second androgen receptor pathway inhibitor","n":126,"value":3.7}],"hr":0.54,"ci":[0.4,0.73],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1911206"},{"endpoint":"Overall survival (median)","unit":"months","arms":[{"name":"Cabazitaxel with prednisone","n":129,"value":13.6},{"name":"Second androgen receptor pathway inhibitor","n":126,"value":11}],"hr":0.64,"ci":[0.46,0.89],"p":"0.008","source":"https://doi.org/10.1056/NEJMoa1911206"},{"endpoint":"PSA response","unit":"%","arms":[{"name":"Cabazitaxel with prednisone","n":129,"value":35.7},{"name":"Second androgen receptor pathway inhibitor","n":126,"value":13.5}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1911206"}],"replication":"Consistent with TheraP and VISION, which both beat a second androgen receptor pathway inhibitor or best supportive care with a radioligand in a similar population."},{"id":"cares-310","kind":"trial","name":"CARES-310","aka":[],"tldr":"A PD-1 antibody plus an oral anti-VEGF pill beat sorafenib on survival, one of the largest benefits seen in liver cancer.","summary":"CARES-310, trial NCT03764293 sponsored by Jiangsu Hengrui and Elevar and reported in 2023, showed that the PD-1 antibody camrelizumab plus the oral anti-VEGF drug rivoceranib beat sorafenib on survival in first-line unresectable hepatocellular carcinoma, one of the largest benefits seen in the disease. It randomised 543 patients in a global trial with about eighty percent Asian enrolment, met both primary endpoints of overall and progression-free survival and produced a much higher response rate. OnCo links it to hepatocellular carcinoma, the camrelizumab plus rivoceranib record, rivoceranib, Jiangsu Hengrui and Shukui Qin. The combination is approved in China but has received three FDA complete response letters over manufacturing, so whether it reaches Western patients is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03764293","url":"https://clinicaltrials.gov/study/NCT03764293"},{"label":"FDA CRL coverage","url":"https://www.cancernetwork.com/view/fda-issues-second-camrelizumab-rivoceranib-crl-in-hepatocellular-carcinoma"}],"tags":[],"related":["src-cancer-network"],"cancers":["hcc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor"],"targets":[],"drugs":["camrelizumab-rivoceranib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["qin-shukui"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03764293","phase":"3","setting":"First-line unresectable HCC: camrelizumab + rivoceranib vs sorafenib","sponsor":"Jiangsu Hengrui / Elevar","result":"OS 23.8 vs 15.2 months, HR 0.62.","started":"2019-06-10","startedType":"actual","yearReported":2023,"enrolled":543,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Camrelizumab + rivoceranib","n":272,"value":23.8},{"name":"Sorafenib","n":271,"value":15.2}],"hr":0.62,"source":"https://doi.org/10.1016/S0140-6736(23)00961-3"},{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Camrelizumab + rivoceranib","value":5.6},{"name":"Sorafenib","value":3.7}],"hr":0.52,"source":"https://doi.org/10.1016/S0140-6736(23)00961-3"}]},{"id":"carmena","kind":"trial","name":"CARMENA","aka":[],"tldr":"CARMENA showed that removing the kidney before starting sunitinib did not help people with kidney cancer that had already spread live longer, which ended the routine practice of upfront nephrectomy for intermediate- and poor-risk patients.","summary":"Removing the primary kidney tumour before systemic therapy had been standard since trials in the interferon era showed a survival benefit. CARMENA, a French non-inferiority phase 3 trial, randomised 450 patients with metastatic clear cell renal cell carcinoma of MSKCC intermediate or poor risk to nephrectomy followed by sunitinib or to sunitinib alone. The primary endpoint was overall survival.\n\nSunitinib alone was non-inferior to nephrectomy plus sunitinib for overall survival, and the poor-risk group did numerically better without surgery. Together with the SURTIME trial it moved practice towards starting systemic therapy first and reserving nephrectomy for selected patients with a good response or few metastases; the question is being revisited in the immunotherapy era.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00930033","url":"https://clinicaltrials.gov/study/NCT00930033"}],"tags":["subtype-trials"],"related":[],"cancers":["clear-cell-rcc","rcc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["sunitinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["arnaud-mejean"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00930033","phase":"3","setting":"Metastatic clear cell renal cell carcinoma of intermediate or poor risk: cytoreductive nephrectomy followed by sunitinib against sunitinib alone","sponsor":"Assistance Publique - Hopitaux de Paris","result":"Sunitinib alone was non-inferior to cytoreductive nephrectomy plus sunitinib for overall survival in intermediate- and poor-risk metastatic clear cell renal cell carcinoma.","started":"2009-09-09","startedType":"actual","yearReported":2018,"enrolled":452,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (planned interim analysis, non-inferiority)","primary":true,"unit":"months","arms":[{"name":"Sunitinib alone","value":18.4,"note":"Non-inferiority boundary 1.20 for the upper 95% CI; median follow-up 50.9 months; 450 enrolled"},{"name":"Nephrectomy then sunitinib","value":13.9}],"hr":0.89,"ci":[0.71,1.1],"source":"https://doi.org/10.1056/nejmoa1803675"}]},{"id":"cartitude-1","kind":"trial","name":"CARTITUDE-1","aka":[],"tldr":"The study that showed one CAR-T infusion could keep a third of heavily pretreated myeloma patients progression-free for five years without further treatment.","summary":"CARTITUDE-1, trial NCT03548207 sponsored by Janssen and Legend and reported in 2021, was the study that showed one CAR-T infusion of ciltacabtagene autoleucel could keep a third of heavily pretreated, triple-class-exposed myeloma patients progression-free for five years without further treatment. In 97 patients after at least three prior lines the response rate was 98 percent with stringent complete responses in 83 percent, and the five-year JCO update in 2025 found a third still progression-free with no maintenance and sustained MRD negativity in most, while movement disorders occurred in about five percent of the early cohort. OnCo links it to multiple myeloma, CAR-T, cilta-cel, Fangliang Zhang, Jesús G. Berdeja, the LEGEND-2 trial and the CARTITUDE-1 paper. Whether those long-term remissions represent cures is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03548207","url":"https://clinicaltrials.gov/study/NCT03548207"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["ciltacabtagene-autoleucel"],"companies":["johnson-johnson","legend-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["zhang-fangliang","jesus-berdeja"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03548207","phase":"1/2","setting":"Relapsed/refractory myeloma after ≥3 lines, triple-class exposed: cilta-cel single infusion","sponsor":"Janssen / Legend","result":"ORR 98%; ~33% progression-free at 5 years without maintenance.","started":"2018-06-29","startedType":"actual","yearReported":2021,"enrolled":97,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Cilta-cel","n":97,"value":97.9}],"source":"https://doi.org/10.1016/S0140-6736(21)00933-8"},{"endpoint":"Progression-free at 5 years","unit":"%","arms":[{"name":"Cilta-cel","value":33}],"source":"https://ascopubs.org/doi/10.1200/JCO-25-00760"}]},{"id":"cartitude-4","kind":"trial","name":"CARTITUDE-4","aka":[],"tldr":"The first randomised trial to show a CAR-T improves survival in myeloma, as early as second line.","summary":"CARTITUDE-4, trial NCT04181827 sponsored by Janssen and Legend and published in the New England Journal of Medicine in 2023, was the first randomised trial to show that a CAR-T improves survival in myeloma, as early as the second line. It randomised 419 lenalidomide-refractory patients after one to three prior lines to ciltacabtagene autoleucel or standard combinations, met its primary progression-free survival endpoint with a very large effect, showed an overall survival benefit at ASCO 2024 and far higher MRD negativity, and led to approval for patients with at least one prior line in April 2024. Whether CAR-T should replace transplant in the frontline, which CARTITUDE-5 and CARTITUDE-6 test, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04181827","url":"https://clinicaltrials.gov/study/NCT04181827"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["ciltacabtagene-autoleucel"],"companies":["johnson-johnson","legend-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jesus-san-miguel"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04181827","phase":"3","setting":"Lenalidomide-refractory myeloma after 1-3 prior lines: cilta-cel vs Pom-Vd or Dara-Pd","sponsor":"Janssen / Legend","result":"PFS HR 0.26; OS HR 0.55.","started":"2020-06-12","startedType":"actual","yearReported":2023,"enrolled":419,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"arms":[{"name":"Cilta-cel","n":208},{"name":"Standard care","n":211}],"hr":0.26,"ci":[0.18,0.38],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2303379"},{"endpoint":"Overall survival","arms":[{"name":"Cilta-cel"},{"name":"Standard care"}],"hr":0.55,"ci":[0.39,0.79],"source":"https://doi.org/10.1056/NEJMoa2303379"}],"replication":"KarMMa-3 (ide-cel) showed a PFS benefit of similar direction but smaller size (HR 0.49) without a clear OS benefit."},{"id":"cartitude-5","kind":"trial","name":"CARTITUDE-5","aka":[],"tldr":"Tests CAR-T as frontline consolidation instead of ongoing lenalidomide in patients not having a transplant.","summary":"CARTITUDE-5, trial NCT04923893 sponsored by Janssen, tests ciltacabtagene autoleucel as frontline consolidation instead of ongoing lenalidomide maintenance in newly diagnosed myeloma patients for whom transplant is not planned, after bortezomib, lenalidomide and dexamethasone induction. Together with CARTITUDE-6, known as EMagine, which compares cilta-cel with autologous transplant after daratumumab-based induction in transplant-eligible patients, it asks whether one CAR-T infusion can replace transplant or maintenance, and there are no results yet. OnCo links it to multiple myeloma, autologous transplant, cilta-cel, the idea of one CAR-T infusion instead of transplant and the CARTITUDE-4 paper. Whether a single infusion can match years of maintenance is the question it exists to answer.","status":"active","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04923893","url":"https://clinicaltrials.gov/study/NCT04923893"}],"tags":[],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["autologous-stem-cell-transplant"],"targets":[],"drugs":["ciltacabtagene-autoleucel"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04923893","phase":"3","setting":"Newly diagnosed myeloma, transplant not planned: VRd → cilta-cel vs VRd → Rd","sponsor":"Janssen","started":"2021-08-19","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"cartitude-6","kind":"trial","name":"CARTITUDE-6","aka":[],"tldr":"CARTITUDE-6 asks whether a single CAR-T infusion can replace the stem cell transplant that has anchored myeloma treatment for thirty years, when both follow the same four-drug induction.","summary":"CARTITUDE-6 (also EMN28) is a phase 3 trial of 759 transplant-eligible patients with newly diagnosed multiple myeloma. All receive DVRd induction; one arm then proceeds to high-dose melphalan and autologous stem cell transplant with DVRd consolidation, the other to a single infusion of the BCMA-directed CAR-T ciltacabtagene autoleucel, and both go on to lenalidomide maintenance. The primary endpoints are progression-free survival and sustained minimal residual disease negativity.\n\nThe trial is running and has not reported. Its answer will decide whether transplant remains the standard consolidation for fit patients or gives way to cellular therapy.","status":"active","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT05257083","url":"https://clinicaltrials.gov/study/NCT05257083"}],"tags":["subtype-trials"],"related":[],"cancers":["myeloma-transplant-eligible","multiple-myeloma"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["daratumumab","bortezomib","lenalidomide","dexamethasone","ciltacabtagene-autoleucel"],"companies":["johnson-johnson","european-myeloma-network"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05257083","phase":"3","setting":"Transplant-eligible newly diagnosed multiple myeloma: daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) followed by ciltacabtagene autoleucel CAR-T against DVRd followed by autologous stem cell transplant","sponsor":"European Myeloma Network with Janssen","started":"2023-10-10","startedType":"actual","enrolled":759,"enrolledBasis":"registry","outcomes":[]},{"id":"caspian","kind":"trial","name":"CASPIAN","aka":[],"tldr":"Confirmed that adding a PD-L1 blocker to first-line chemotherapy helps in small-cell lung cancer, and showed that adding a second immunotherapy did not help further.","summary":"CASPIAN, trial NCT03043872 sponsored by AstraZeneca and reported in 2019, confirmed that adding the PD-L1 antibody durvalumab to first-line platinum and etoposide helps in extensive-stage small-cell lung cancer, and showed that adding the CTLA-4 antibody tremelimumab did not help further. It randomised 805 patients, met its primary overall survival endpoint for durvalumab plus chemotherapy with a durable minority alive at three years, allowed cisplatin or carboplatin and up to six chemotherapy cycles in the control arm, and led to FDA approval in March 2020. OnCo links it to small-cell lung cancer, durvalumab, tremelimumab, the platinum-etoposide record, Luis Paz-Ares and CAPSTONE-1, and the result is consistent with IMpower133 while the failure of the CTLA-4 add-on was itself replicated by other attempts. Why only a minority gain durable benefit remains the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03043872","url":"https://clinicaltrials.gov/study/NCT03043872"}],"tags":[],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab","platinum-etoposide"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["luis-paz-ares"],"bottlenecks":[],"keyPapers":["paper-paz-ares-caspian-durvalumab-es-sclc-lancet-2019","paper-caspian-lancet-oncol-2021-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03043872","phase":"3","setting":"First-line extensive-stage SCLC: platinum-etoposide + durvalumab (± tremelimumab) vs platinum-etoposide","sponsor":"AstraZeneca","result":"OS 13.0 vs 10.3 months, HR 0.73; 3-year OS 17.6% vs 5.8%.","started":"2017-03-27","startedType":"actual","yearReported":2019,"enrolled":805,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Durvalumab + EP","n":268,"value":13},{"name":"EP alone","n":269,"value":10.3}],"hr":0.73,"ci":[0.59,0.91],"p":"0.0047","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32222-6/fulltext"},{"endpoint":"3-year overall survival rate","unit":"%","arms":[{"name":"Durvalumab + EP","value":17.6},{"name":"EP alone","value":5.8}],"source":"https://doi.org/10.1016/S0140-6736(19)32222-6"}],"replication":"Consistent with IMpower133; the durvalumab-tremelimumab arm's failure was itself replicated by other CTLA-4 add-on attempts in SCLC."},{"id":"cassiopeia","kind":"trial","name":"CASSIOPEIA","aka":[],"tldr":"CASSIOPEIA showed that adding the CD38 antibody daratumumab to a three-drug induction before stem cell transplant put more people with myeloma into deep remission and kept the disease away for longer.","summary":"CASSIOPEIA, run by the French and Dutch myeloma groups with Janssen, randomised 1085 transplant-eligible patients with newly diagnosed multiple myeloma to VTd (bortezomib, thalidomide, dexamethasone) induction and post-transplant consolidation with or without daratumumab (part 1), then re-randomised responders to daratumumab maintenance or observation (part 2). The part 1 primary endpoint was the stringent complete response rate after consolidation.\n\nDaratumumab-VTd increased stringent complete responses and minimal residual disease negativity and lengthened progression-free survival, leading to European and United States approval of the quadruplet in 2019 and 2020, the first daratumumab approval in the transplant setting. Part 2 showed that daratumumab maintenance lengthened progression-free survival mainly in patients who had not received it during induction.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02541383","url":"https://clinicaltrials.gov/study/NCT02541383"}],"tags":["subtype-trials"],"related":[],"cancers":["myeloma-transplant-eligible","multiple-myeloma"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["daratumumab","bortezomib","thalidomide","dexamethasone"],"companies":["johnson-johnson","ifm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["philippe-moreau"],"bottlenecks":[],"keyPapers":["paper-cassiopeia-lancet-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02541383","phase":"3","setting":"Transplant-eligible newly diagnosed multiple myeloma: bortezomib, thalidomide and dexamethasone (VTd) induction and consolidation with or without daratumumab, then daratumumab maintenance or observation","sponsor":"Intergroupe Francophone du Myelome","result":"Daratumumab added to VTd increased stringent complete responses and lengthened progression-free survival; approved for transplant-eligible myeloma in 2019 (EU) and 2020 (US).","started":"2015-09","startedType":"actual","yearReported":2019,"enrolled":1085,"enrolledBasis":"registry","outcomes":[{"endpoint":"Stringent complete response at day 100 after transplantation (part 1)","primary":true,"unit":"%","arms":[{"name":"Daratumumab + VTd","n":543,"value":29},{"name":"VTd","n":542,"value":20}],"p":"0.0010","source":"https://doi.org/10.1016/S0140-6736(19)31240-1"},{"endpoint":"Minimal residual disease negativity (10^-5, flow cytometry)","unit":"%","arms":[{"name":"Daratumumab + VTd","n":543,"value":64},{"name":"VTd","n":542,"value":44}],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(19)31240-1"},{"endpoint":"Progression-free survival from first randomisation","unit":"months","arms":[{"name":"Daratumumab + VTd","note":"Not reached"},{"name":"VTd","note":"Not reached"}],"hr":0.47,"ci":[0.33,0.67],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(19)31240-1"}]},{"id":"nct06690775","kind":"trial","name":"CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.","aka":["CATALINA-2"],"tldr":"A phase 2 trial of Pegfilgrastim in ovarian cancer, run by TORL Biotherapeutics, LLC, now recruiting.","summary":"CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer. is a phase 2 interventional study registered as NCT06690775 by TORL Biotherapeutics, LLC, with 230 participants planned, started 2024-11-20 and due to reach its primary completion in 2027-10. Interventions recorded: TORL-1-23, TORL-1-23, TORL-1-23, Pegfilgrastim (drug). Conditions listed: Epithelial Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancer, Endometrioid Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06690775","url":"https://clinicaltrials.gov/study/NCT06690775"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["g-csf-growth-factors"],"targets":[],"drugs":["pegfilgrastim"],"companies":["torl-biotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06690775","phase":"2","setting":"Catalina-2: A Phase 2 Study Evaluating the Efficacy and Safety of TORL-1-23 in Women With Advanced Platinum-Resistant Epithelial Ovarian Cancer (Including Primary Peritoneal and Fallopian Tube Cancers) Expressing Claudin 6","sponsor":"TORL Biotherapeutics, LLC","started":"2024-11-20","startedType":"actual","enrolled":230,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07322094","kind":"trial","name":"CATALINA-4: A Study to Investigate the Safety and Efficacy of TORL-1-23 With Chemotherapy Given Before Initial Surgery in Women With Advanced Stage Ov","aka":["CATALINA-4"],"tldr":"A phase 1/2 trial of Paclitaxel / nab-paclitaxel, Carboplatin in ovarian cancer, run by TORL Biotherapeutics, LLC, now recruiting.","summary":"CATALINA-4: A Study to Investigate the Safety and Efficacy of TORL-1-23 With Chemotherapy Given Before Initial Surgery in Women With Advanced Stage Ovarian Cancer is a phase 1/2 interventional study registered as NCT07322094 by TORL Biotherapeutics, LLC, with 60 participants planned, started 2025-12-10 and due to reach its primary completion in 2027-12. Interventions recorded: TORL-1-23 and paclitaxel, TORL-1-23 and carboplatin, TORL-1-23, paclitaxel, and carboplatin. Conditions listed: FIGO Stage III and IV Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07322094","url":"https://clinicaltrials.gov/study/NCT07322094"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["paclitaxel","carboplatin"],"companies":["torl-biotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07322094","phase":"1/2","setting":"CATALINA-4: Phase 1B/2 Study of TORL-1-23 With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Newly Diagnosed Patients With Advanced Stage Ovarian Cancer","sponsor":"TORL Biotherapeutics, LLC","started":"2025-12-10","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"catnon","kind":"trial","name":"CATNON (EORTC 26053-22054)","aka":[],"tldr":"CATNON showed that a year of temozolomide after radiotherapy lengthens survival in anaplastic gliomas that lack the 1p/19q co-deletion, and that the benefit is concentrated in IDH-mutant tumours.","summary":"CATNON randomised 751 adults with newly diagnosed 1p/19q non-co-deleted anaplastic glioma in a two-by-two design to radiotherapy alone, with concurrent temozolomide, with 12 cycles of adjuvant temozolomide, or both. Adjuvant temozolomide improved overall survival (hazard ratio 0.65 in the interim analysis; five-year survival 55.9 vs 44.1 percent), while concurrent temozolomide did not in the tumours as a whole and helped only IDH-mutant tumours (van den Bent and colleagues, Lancet 2017 and Lancet Oncology 2021).","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT00626990","url":"https://clinicaltrials.gov/study/NCT00626990"},{"label":"Lancet 2017","url":"https://doi.org/10.1016/S0140-6736(17)31442-3"}],"tags":["radiation-wave2"],"related":[],"cancers":["glioblastoma","brain-tumours","idh-mutant-astrocytoma"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["temozolomide"],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["chemoradiation"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00626990","phase":"3","setting":"Newly diagnosed anaplastic glioma without 1p/19q co-deletion: radiotherapy with or without concurrent and with or without adjuvant temozolomide","sponsor":"EORTC","result":"Adjuvant temozolomide: overall survival hazard ratio 0.65; 5-year survival 55.9% vs 44.1%. Concurrent temozolomide benefit confined to IDH-mutant tumours.","started":"2007-12","startedType":"actual","yearReported":2017,"enrolled":751,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Adjuvant temozolomide","value":55.9,"note":"Interim analysis after 219 deaths, 745 patients enrolled; hazard ratio 0.65 with 99.145% CI 0.45-0.93"},{"name":"No adjuvant temozolomide","value":44.1}],"hr":0.65,"source":"https://doi.org/10.1016/S0140-6736(17)31442-3"}]},{"id":"cave","kind":"trial","name":"CAVE mCRC","aka":["CAVE"],"tldr":"Adding a PD-L1 antibody to an EGFR antibody given a second time helped most in patients whose blood showed no resistance mutations, a seven-month difference in survival between the two groups.","summary":"CAVE enrolled 77 patients with pretreated RAS wild-type metastatic colorectal cancer, 71 of them microsatellite-stable, and gave cetuximab rechallenge with avelumab. The trial met its primary endpoint with a median overall survival of 11.6 months (95% CI 8.4 to 14.8) and median progression-free survival of 3.6 months. Baseline circulating tumour DNA for KRAS, NRAS, BRAF and EGFR S492R was analysable in 67 of 77 (87 percent); 48 patients were wild-type in plasma and 19 mutated. Median overall survival was 17.3 months in the plasma wild-type group against 10.4 months in the mutated group (hazard ratio 0.49, 95% CI 0.27 to 0.90, p=0.02), and progression-free survival 4.1 against 3.0 months (hazard ratio 0.42, 0.23 to 0.75, p=0.004). Grade 3 cutaneous eruption affected 14 percent. A later pooled analysis of 180 patients found that the absence of liver metastases and a longer anti-EGFR-free interval mark out who benefits. Like CHRONOS, CAVE is single-arm: it establishes that plasma RAS status selects for rechallenge benefit, not that rechallenge beats standard later-line treatment.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04561336","url":"https://clinicaltrials.gov/study/NCT04561336"},{"label":"CAVE: cetuximab plus avelumab as rechallenge therapy in RAS wild-type metastatic colorectal cancer (JAMA Oncology 2021)","url":"https://doi.org/10.1001/jamaoncol.2021.2915"},{"label":"CAVE pooled analysis of clinical factors and outcomes (ESMO Gastrointestinal Oncology 2026)","url":"https://doi.org/10.1016/j.esmogo.2026.100398"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["monoclonal-antibody","checkpoint-inhibitor","liquid-biopsy"],"targets":["egfr","pd1"],"drugs":["cetuximab","avelumab"],"companies":[],"institutions":[],"pathways":[],"terms":["ctdna","msi"],"trials":["chronos"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04561336","phase":"2","setting":"Pretreated RAS wild-type metastatic colorectal cancer: cetuximab rechallenge with the PD-L1 antibody avelumab, single arm","sponsor":"University of Campania Luigi Vanvitelli","result":"Median overall survival 11.6 months overall; 17.3 months with RAS and BRAF wild-type plasma against 10.4 months with mutated plasma (hazard ratio 0.49).","started":"2018-08-10","startedType":"actual","yearReported":2021,"enrolled":77,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Cetuximab rechallenge plus avelumab","n":77,"value":11.6}],"ci":[8.4,14.8],"source":"https://doi.org/10.1001/jamaoncol.2021.2915"},{"endpoint":"Overall survival by baseline plasma RAS and BRAF status","unit":"months","arms":[{"name":"Plasma wild-type","n":48,"value":17.3},{"name":"Plasma mutated","n":19,"value":10.4}],"hr":0.49,"ci":[0.27,0.9],"p":"0.02","source":"https://doi.org/10.1001/jamaoncol.2021.2915"}],"replication":"A 2026 pooled analysis of 180 patients found median overall survival 15.7 months with cetuximab and avelumab against 12.9 months with cetuximab alone, with liver involvement and a short anti-EGFR-free interval marking out non-responders."},{"id":"cctg-ce6","kind":"trial","name":"CCTG CE.6 / EORTC 26062-22061 (Perry trial)","aka":[],"tldr":"The trial that set treatment for older patients with glioblastoma: three weeks of radiotherapy instead of six, with temozolomide added, extended survival without worsening quality of life.","summary":"CCTG CE.6 with EORTC 26062-22061 and TROG 08.02, trial NCT00482677, randomised 562 patients aged 65 or older (median 73) with newly diagnosed glioblastoma to short-course radiotherapy (40 Gy in 15 fractions) with or without concurrent and adjuvant temozolomide. Median overall survival was 9.3 versus 7.6 months (HR 0.67, 95% CI 0.56-0.80) and median progression-free survival 5.3 versus 3.9 months; with a methylated MGMT promoter, 13.5 versus 7.7 months (HR 0.53), and with an unmethylated promoter 10.0 versus 7.9 months (HR 0.75, 95% CI 0.56-1.01). Quality of life was similar in the two arms. Published by Perry and colleagues in NEJM in 2017. Two earlier trials had established the alternatives for older or frail patients: the Nordic trial (Malmström 2012; temozolomide alone or hypofractionated radiotherapy at least as good as standard six-week radiotherapy over age 60, and better over 70) and NOA-08 (Wick 2012; temozolomide alone non-inferior to radiotherapy alone, with MGMT methylation predicting who benefits from temozolomide).","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00482677","url":"https://clinicaltrials.gov/study/NCT00482677"},{"label":"Perry et al., Short-course radiation plus temozolomide in elderly patients with glioblastoma (NEJM 2017)","url":"https://doi.org/10.1056/NEJMoa1611977"},{"label":"Malmström et al., Temozolomide versus standard 6-week radiotherapy versus hypofractionated radiotherapy in patients older than 60 years with glioblastoma: the Nordic randomised, phase 3 trial (Lancet Oncology 2012)","url":"https://doi.org/10.1016/S1470-2045(12)70265-6"},{"label":"Wick et al., Temozolomide chemotherapy alone versus radiotherapy alone for malignant astrocytoma in the elderly: the NOA-08 randomised, phase 3 trial (Lancet Oncology 2012)","url":"https://doi.org/10.1016/S1470-2045(12)70164-X"}],"tags":[],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["temozolomide"],"companies":["cctg","curie-nki-eortc","trog"],"institutions":[],"pathways":[],"terms":["mgmt"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-malmstrom-lancet-oncol","paper-perry-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00482677","phase":"3","setting":"Newly diagnosed glioblastoma, age 65 or older: short-course radiotherapy (40 Gy in 15 fractions) with concurrent and adjuvant temozolomide vs short-course radiotherapy alone","sponsor":"Canadian Cancer Trials Group / EORTC / TROG","result":"OS 9.3 vs 7.6 months, HR 0.67 (95% CI 0.56-0.80).","started":"2007-11-14","startedType":"actual","yearReported":2017,"enrolled":562,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, age 65 or older","primary":true,"unit":"months","arms":[{"name":"Short-course RT + temozolomide","n":281,"value":9.3},{"name":"Short-course RT alone","n":281,"value":7.6}],"hr":0.67,"ci":[0.56,0.8],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1611977"}],"replication":"Single randomised trial of adding temozolomide to short-course radiotherapy; the Nordic and NOA-08 trials support hypofractionated radiotherapy or temozolomide alone in older patients, with MGMT status guiding the choice."},{"id":"nct04718883","kind":"trial","name":"CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma","aka":[],"tldr":"A phase 2 trial of CD19-targeted Chimeric Antigen Receptor (CAR) T Cells in mantle cell lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd., active and no longer recruiting.","summary":"CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma is a phase 2 interventional study registered as NCT04718883 by Shanghai Ming Ju Biotechnology Co., Ltd., with 59 participants enrolled, started 2021-01-13 and due to reach its primary completion in 2023-10-25. Interventions recorded: CD19-targeted Chimeric Antigen Receptor (CAR) T Cells.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04718883","url":"https://clinicaltrials.gov/study/NCT04718883"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["jw-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04718883","phase":"2","setting":"A Phase II Open-Label, Single-Arm, Multicenter Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma","sponsor":"Shanghai Ming Ju Biotechnology Co., Ltd.","started":"2021-01-13","startedType":"actual","enrolled":59,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06479356","kind":"trial","name":"CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma","aka":[],"tldr":"A phase 2 trial of Relmacabtagene autoleucel in hodgkin lymphoma and non-hodgkin lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd., now recruiting.","summary":"CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma is a phase 2 interventional study registered as NCT06479356 by Shanghai Ming Ju Biotechnology Co., Ltd., with 12 participants planned, started 2024-08-15 and due to reach its primary completion in 2025-04-30. Interventions recorded: Relma-cel. Conditions listed: Non-Hodgkin Lymphoma, Large B-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06479356","url":"https://clinicaltrials.gov/study/NCT06479356"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["relmacabtagene-autoleucel"],"companies":["jw-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06479356","phase":"2","setting":"An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed or Refractory (R/R) LBCL","sponsor":"Shanghai Ming Ju Biotechnology Co., Ltd.","started":"2024-08-15","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07153289","kind":"trial","name":"CD318-targeted CAR-T Cell Therapy in Patients With Pancreatic Cancer (ResCPa)","aka":["ResCPa"],"tldr":"A phase 1/2 trial in pancreatic cancer, run by University Hospital Tuebingen, not yet recruiting.","summary":"CD318-targeted CAR-T Cell Therapy in Patients With Pancreatic Cancer (ResCPa) is a phase 1/2, interventional study registered as NCT07153289 by University Hospital Tuebingen, with a registry enrolment figure of 38 participants, started 2026-07 and due to reach its primary completion in 2028-12. Interventions recorded: CD318-CAR-T cells. Conditions listed: Carcinoma, Pancreatic Ductal; Pancreatic Neoplasms. Primary outcome: Incidence and severity of dose-limiting toxicities (DLTs) and adverse events (AEs) after CD318-CAR-T cell infusion.. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07153289","url":"https://clinicaltrials.gov/study/NCT07153289"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07153289","phase":"1/2","setting":"Response Features, Efficacy and Safety of CD318-targeted CAR-T Cell Therapy Against Pancreatic Cancer - ResCPa Study","sponsor":"University Hospital Tuebingen","started":"2026-07","startedType":"estimated","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06538857","kind":"trial","name":"CEB-01 in Locally Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of Standard surgery in pancreatic ductal adenocarcinoma, run by CEBIOTEX, now recruiting.","summary":"CEB-01 in Locally Resectable Pancreatic Cancer is a phase 2 interventional study registered as NCT06538857 by CEBIOTEX, with 39 participants planned, started 2024-08-20 and due to reach its primary completion in 2028-09. Interventions recorded: Standard surgery and CEB-01.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06538857","url":"https://clinicaltrials.gov/study/NCT06538857"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["cebiotex"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06538857","phase":"2","setting":"Exploratory Clinical Trial to Assess Safety, Tolerability Efficacy and Pharmacokinetics of CEB-01 PLGA Membrane in Participants With Pancreatic Cancer.","sponsor":"CEBIOTEX","started":"2024-08-20","startedType":"actual","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06986811","kind":"trial","name":"CEB-01 in Paediatrics With Locally Resectable Abdominal Tumours","aka":[],"tldr":"A phase 2 trial of Standard surgery in childhood cancers, run by CEBIOTEX, now recruiting.","summary":"CEB-01 in Paediatrics With Locally Resectable Abdominal Tumours is a phase 2 interventional study registered as NCT06986811 by CEBIOTEX, with 60 participants planned, started 2025-05-06 and due to reach its primary completion in 2029-05. Interventions recorded: Standard surgery and CEB-01.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06986811","url":"https://clinicaltrials.gov/study/NCT06986811"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["childhood-cancers"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["cebiotex"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06986811","phase":"2","setting":"First-in-paediatrics, Open Label, Exploratory, Externally Controlled Clinical Trial to Evaluate Safety, Efficacy and Pharmacokinetics of 7-ethyl-10-hydroxy Camptothecin (SN-38) Formulated as a Biocompatible Polymeric Nanofiber Membrane (CEB-01) for Treatment, in Addition to Standard of Care, of Paediatric Patients From Birth to Less Than 18 Years of Age With a Locally Resectable Tumours in Comparison to Standard of Care","sponsor":"CEBIOTEX","started":"2025-05-06","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00399035","kind":"trial","name":"Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer","aka":["HORIZON II"],"tldr":"A phase 3 trial of Cediranib, FOLFOX, Leucovorin, Oxaliplatin, Fluorouracil and CAPOX in Colorectal cancer, run by AstraZeneca, completed.","summary":"Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer is a phase 3 interventional study registered as NCT00399035 by AstraZeneca, with 1254 participants recorded, started 2006-11 and reaching its primary completion in 2010-03. Interventions recorded: Cediranib, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin), XELOX (Capecitabine and Oxaliplatin), Cediranib Placebo. Conditions recorded: Metastatic Colorectal Cancer.\n\nLinked to the drug Cediranib because the registry names it among its interventions and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00399035","url":"https://clinicaltrials.gov/study/NCT00399035"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["cediranib","folfox","leucovorin","oxaliplatin","fluorouracil","capox"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00399035","phase":"3","setting":"A Randomised, Double-blind, Phase III Study to Compare the Efficacy and Safety of Cediranib (AZD2171, RECENTIN™) When Added to 5 Fluorouracil, Leucovorin and Oxaliplatin (FOLFOX) or Capecitabine and Oxaliplatin (XELOX) With the Efficacy and Safety of Placebo When Added to FOLFOX or XELOX in Patients With Previously Untreated Metastatic Colorectal Cancer.","sponsor":"AstraZeneca","started":"2006-11","yearReported":2012,"enrolled":1254,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival","primary":true,"unit":"months","arms":[{"name":"Cediranib 20 mg","n":502,"value":8.6,"note":"IQR 5.5 to 12.1; Figures from the ClinicalTrials.gov results section (first posted 2012-10-30), not from a publication"},{"name":"Placebo","n":358,"value":8.2,"note":"IQR 4.1 to 11.1"}],"source":"https://clinicaltrials.gov/study/NCT00399035?tab=results"},{"endpoint":"Overall Survival","primary":true,"unit":"months","arms":[{"name":"Cediranib 20 mg","n":502,"value":19.7,"note":"IQR 11.0 to 36.1; Figures from the ClinicalTrials.gov results section (first posted 2012-10-30), not from a publication"},{"name":"Placebo","n":358,"value":18.9,"note":"IQR 11.0 to 28.9"}],"source":"https://clinicaltrials.gov/study/NCT00399035?tab=results"},{"endpoint":"Overall Response Rate","unit":"participants","arms":[{"name":"Cediranib 20 mg","n":502,"value":254,"note":"Figures from the ClinicalTrials.gov results section (first posted 2012-10-30), not from a publication"},{"name":"Placebo","n":358,"value":178}],"source":"https://clinicaltrials.gov/study/NCT00399035?tab=results"}]},{"id":"nct00777153","kind":"trial","name":"Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma","aka":["REGAL"],"tldr":"A phase 3 trial of Cediranib in Glioma & glioblastoma, run by AstraZeneca, completed.","summary":"Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma is a phase 3 interventional study registered as NCT00777153 by AstraZeneca, with 423 participants recorded, started 2008-10 and reaching its primary completion in 2010-04. Interventions recorded: Cediranib, Cediranib, Lomustine Chemotherapy, Placebo Cediranib. Conditions recorded: Recurrent Glioblastoma.\n\nLinked to the drug Cediranib because the registry names it among its interventions and Glioma & glioblastoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00777153","url":"https://clinicaltrials.gov/study/NCT00777153"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":["cediranib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00777153","phase":"3","setting":"A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib With Lomustine to the Efficacy of Lomustine Alone","sponsor":"AstraZeneca","started":"2008-10","yearReported":2012,"enrolled":423,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"days","arms":[{"name":"Cediranib 30mg","n":131,"value":92,"note":"IQR 80 to 128; Figures from the ClinicalTrials.gov results section (first posted 2012-12-21), not from a publication"},{"name":"Cediranib 20mg+ Lomustine 110mg","n":129,"value":125,"note":"IQR 83 to 201"},{"name":"Lomustine 110mg","n":65,"value":82,"note":"IQR 42 to 168"}],"source":"https://clinicaltrials.gov/study/NCT00777153?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Cediranib 30mg","n":131,"value":8,"note":"IQR 4.1 to 14.5; Figures from the ClinicalTrials.gov results section (first posted 2012-12-21), not from a publication"},{"name":"Cediranib 20mg + Lomustine 110mg","n":129,"value":9.4,"note":"IQR 6.2 to 14.5"},{"name":"Lomustine 110mg","n":65,"value":9.8,"note":"IQR 4.9 to NA"}],"source":"https://clinicaltrials.gov/study/NCT00777153?tab=results"}]},{"id":"celestial","kind":"trial","name":"CELESTIAL","aka":[],"tldr":"Cabozantinib extended survival in previously treated liver cancer, including after two prior therapies.","summary":"CELESTIAL, trial NCT01908426 sponsored by Exelixis and reported in 2018, showed that cabozantinib extends survival in previously treated hepatocellular carcinoma, including after two prior lines of therapy. It randomised 707 patients who had received sorafenib to cabozantinib or placebo and met its primary overall survival endpoint, with a marked improvement in progression-free survival. OnCo links it to hepatocellular carcinoma and to the cabozantinib drug record. Since first-line treatment has moved to immunotherapy combinations, whether cabozantinib keeps its benefit as a second-line option after atezolizumab and bevacizumab or dual checkpoint blockade is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01908426","url":"https://clinicaltrials.gov/study/NCT01908426"}],"tags":[],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["cabozantinib"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01908426","phase":"3","setting":"HCC after sorafenib (up to two prior lines): cabozantinib vs placebo","sponsor":"Exelixis","result":"OS 10.2 vs 8.0 months, HR 0.76.","started":"2013-09-26","yearReported":2018,"enrolled":707,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Cabozantinib","n":470,"value":10.2},{"name":"Placebo","n":237,"value":8}],"hr":0.76,"ci":[0.63,0.92],"p":"0.005","source":"https://doi.org/10.1056/NEJMoa1717002"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Cabozantinib","value":5.2},{"name":"Placebo","value":1.9}],"hr":0.44,"source":"https://doi.org/10.1056/NEJMoa1717002"}]},{"id":"celestial-tncll","kind":"trial","name":"CELESTIAL-TNCLL","aka":[],"tldr":"CELESTIAL-TNCLL tests the next-generation all-oral doublet against the current fixed-duration standard, with results expected from late 2026.","summary":"CELESTIAL-TNCLL, trial NCT06073821 sponsored by BeOne, formerly BeiGene, is the phase 3 that tests the next-generation all-oral doublet of sonrotoclax and zanubrutinib against the fixed-duration standard of venetoclax plus obinutuzumab in previously untreated chronic lymphocytic leukaemia, with results expected from late 2026. It follows the BGB-11417-101 study, in which the doublet produced undetectable MRD in almost all treatment-naive patients by week 96 including high-risk genetics, its estimated primary completion is November 2026, and a companion trial tests the doublet against zanubrutinib alone. Whether a second-generation BCL-2 inhibitor improves on venetoclax in a randomised comparison is the question it will answer.","status":"active","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06073821","url":"https://clinicaltrials.gov/study/NCT06073821"},{"label":"CLL Society update (July 2026)","url":"https://cllsociety.org/2026/07/an-update-on-sonrotoclax-plus-zanubrutinib-for-cll/"}],"tags":[],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":["bcl2","btk"],"drugs":["sonrotoclax","zanubrutinib","venetoclax","obinutuzumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06073821","phase":"3","setting":"Previously untreated CLL/SLL: fixed-duration sonrotoclax + zanubrutinib vs venetoclax + obinutuzumab","sponsor":"BeOne (BeiGene)","started":"2023-11-11","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"cemiplimab-kidney-transplant-cscc","kind":"trial","name":"Cemiplimab for kidney transplant recipients with advanced skin squamous cell carcinoma","aka":["cemiplimab in kidney transplant recipients"],"tldr":"Transplant patients are kept out of immunotherapy trials because the drugs can make the body reject the transplanted organ. This small study changed the anti-rejection drugs first, then gave the immunotherapy, and no one lost their kidney while nearly half saw their cancer shrink.","summary":"Solid organ transplant recipients carry the highest risk of cutaneous squamous cell carcinoma of any group, and the drug that works for advanced disease is the one they are excluded from receiving, because PD-1 blockade can trigger rejection of the graft. That exclusion is not a footnote: it means the group with the worst disease has no evidence at all.\n\nThis phase 1 study at Dana-Farber built a protocol around the problem. Immunosuppression was cross-tapered to a mammalian target of rapamycin inhibitor, and prednisone was pulsed around each cycle at 40 mg daily from the day before through day 3, 20 mg on days 4 to 6 and 10 mg until the day before the next cycle. Cemiplimab 350 mg was then given every three weeks for up to two years.\n\nTwelve patients were treated. No kidney rejection and no graft loss occurred, which was the primary endpoint. A response was seen in five of eleven evaluable patients (46 per cent, 90 per cent confidence interval 22 to 73), two of them lasting beyond a year. Median follow-up was 6.8 months, with a range of 0.7 to 29.8.\n\nThe risks were not only immunological. Treatment-related grade 3 or higher adverse events occurred in five patients (42 per cent), including diarrhoea, infection and metabolic disturbance, and one patient died of angioedema and anaphylaxis attributed to the mammalian target of rapamycin inhibitor cross-taper, not to the cemiplimab. Twelve patients is twelve patients. But it is the first prospective evidence that the combination can be given, and the regimen it describes is what a transplant nephrologist and an oncologist can now discuss instead of refusing treatment outright.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04339062","url":"https://clinicaltrials.gov/study/NCT04339062"},{"label":"Primary report (Journal of Clinical Oncology 2024)","url":"https://doi.org/10.1200/JCO.23.01498"},{"label":"Primary report on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/38252908/"}],"tags":[],"related":[],"cancers":["cutaneous-scc","advanced-cutaneous-scc","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":["dana-farber"],"pathways":[],"terms":["skin-cancer-after-organ-transplant","irae"],"trials":["tumorapa","empower-cscc-1"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04339062","phase":"1/2","setting":"Kidney transplant recipients with advanced cutaneous squamous cell carcinoma: cross-taper of immunosuppression to a mammalian target of rapamycin inhibitor with pulsed corticosteroids around each cycle, then cemiplimab 350 mg every three weeks for up to two years, with the rate of kidney rejection as the primary endpoint","sponsor":"Dana-Farber Cancer Institute, funded by Regeneron Pharmaceuticals","result":"No kidney rejection or graft loss in 12 kidney transplant recipients given cemiplimab after cross-taper to a mammalian target of rapamycin inhibitor with pulsed corticosteroids, with responses in 5 of 11 evaluable patients (46 per cent, 90 per cent confidence interval 22 to 73).","started":"2020-11-03","startedType":"actual","yearReported":2024,"enrolled":12,"enrolledBasis":"registry","outcomes":[{"endpoint":"Kidney rejection or graft loss","primary":true,"unit":"events","arms":[{"name":"Cemiplimab with mammalian target of rapamycin inhibitor and pulsed prednisone","n":12,"value":0}],"source":"https://doi.org/10.1200/jco.23.01498"},{"endpoint":"Objective response","unit":"%","arms":[{"name":"Cemiplimab with mammalian target of rapamycin inhibitor and pulsed prednisone","n":11,"value":46,"note":"5 of 11 evaluable patients; 90 per cent confidence interval 22 to 73; 2 responses beyond a year"}],"source":"https://doi.org/10.1200/jco.23.01498"},{"endpoint":"Treatment-related grade 3 or higher adverse events","unit":"%","arms":[{"name":"Cemiplimab with mammalian target of rapamycin inhibitor and pulsed prednisone","n":12,"value":42,"note":"5 of 12 patients; one death from angioedema and anaphylaxis attributed to the cross-taper"}],"source":"https://doi.org/10.1200/jco.23.01498"}],"replication":"Case series support it without settling it: a Belgian cohort of seven kidney transplant recipients given cemiplimab reported an overall response rate of 42.8 per cent with biopsy-proven acute rejection in one patient, who lost graft function but had a complete tumour response (Frontiers in Nephrology 2022, PubMed 37675002)."},{"id":"cemiplimab-advanced-bcc","kind":"trial","name":"Cemiplimab in basal cell carcinoma after a hedgehog inhibitor","aka":["Study 1620","cemiplimab in locally advanced basal cell carcinoma"],"tldr":"Before this trial there was nothing to offer someone whose basal cell carcinoma had outgrown or outlasted the hedgehog pill. Immunotherapy shrank the tumour in about a third of them, and it is now the standard second treatment.","summary":"Until February 2021 there was no standard treatment for locally advanced basal cell carcinoma after a hedgehog inhibitor, and since most people either progress or stop the pill because of its side effects, that gap covered the majority of patients who ever start one. This open-label single-arm trial at 38 centres in Canada, Europe and the United States enrolled patients who had progressed on, could not tolerate, or had no better than stable disease after nine months of hedgehog inhibitor therapy, and gave cemiplimab 350 mg every three weeks for up to 93 weeks.\n\nEighty-four patients were treated between November 2017 and January 2019. At a median follow-up of 15 months, objective response by independent central review was seen in 26 of 84 (31 per cent, 95 per cent confidence interval 21 to 42), with five complete responses (6 per cent) and 21 partial responses (25 per cent).\n\nToxicity was that of PD-1 blockade and it was not trivial in this elderly population: grade 3 or 4 treatment-emergent adverse events in 40 of 84 (48 per cent), most commonly hypertension and colitis at 5 per cent each, and serious treatment-emergent events in 29 (35 per cent). There were no treatment-related deaths.\n\nA response rate of 31 per cent is lower than the 43 to 68 per cent reported for first-line hedgehog inhibitors, but the comparison is unfair: this is a population selected for hedgehog failure. What the trial establishes is a second line where there was none. Basal cell carcinoma, long thought a cold tumour because it rarely spreads, turns out to respond to checkpoint blockade, which fits its very high ultraviolet mutational burden.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03132636","url":"https://clinicaltrials.gov/study/NCT03132636"},{"label":"Primary analysis (Lancet Oncology 2021)","url":"https://doi.org/10.1016/S1470-2045(21)00126-1"},{"label":"Primary analysis on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/34000246/"}],"tags":[],"related":[],"cancers":["basal-cell-carcinoma","locally-advanced-bcc","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["cemiplimab"],"companies":["regeneron","sanofi"],"institutions":[],"pathways":[],"terms":["hedgehog-inhibitor-tolerability","irae","tmb"],"trials":["erivance","bolt","stevie"],"people":[],"bottlenecks":[],"keyPapers":["paper-cemiplimab-bcc-stratigos-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03132636","phase":"2","setting":"Locally advanced basal cell carcinoma in patients who had progressed on, were intolerant of, or had no better than stable disease after nine months of hedgehog inhibitor therapy: cemiplimab 350 mg intravenously every three weeks for up to 93 weeks, with objective response by independent central review as the primary endpoint","sponsor":"Regeneron Pharmaceuticals and Sanofi","result":"Objective response by independent central review in 26 of 84 patients (31 per cent, 95 per cent confidence interval 21 to 42) with five complete responses; grade 3 or 4 treatment-emergent adverse events in 48 per cent.","started":"2017-06-29","startedType":"actual","yearReported":2021,"enrolled":84,"enrolledBasis":"treated","enrolledNote":"84 patients with locally advanced disease (group 2) were enrolled and treated and are the population of the primary analysis; the ClinicalTrials.gov record NCT03132636 gives a total enrolment of 138 across both groups, and the metastatic group was reported separately when it matured.","outcomes":[{"endpoint":"Objective response by independent central review","primary":true,"unit":"%","arms":[{"name":"Cemiplimab 350 mg every 3 weeks","n":84,"value":31,"note":"26 of 84 patients; 95 per cent confidence interval 21 to 42; 5 complete and 21 partial responses"}],"source":"https://doi.org/10.1016/s1470-2045(21)00126-1"},{"endpoint":"Grade 3 or 4 treatment-emergent adverse events","unit":"%","arms":[{"name":"Cemiplimab 350 mg every 3 weeks","n":84,"value":48,"note":"40 of 84 patients; serious treatment-emergent events in 35 per cent"}],"source":"https://doi.org/10.1016/s1470-2045(21)00126-1"}],"replication":"No randomised comparison exists. Cemiplimab was approved in this setting in February 2021 on this single-arm evidence, and there is no NICE technology appraisal of it for basal cell carcinoma."},{"id":"cemiplimab-nut","kind":"trial","name":"Cemiplimab in metastatic or unresectable NUT carcinoma (Northwestern pilot)","aka":[],"tldr":"The first dedicated immunotherapy trial in NUT carcinoma, asking whether a PD-1 antibody can do anything in a cancer that chemotherapy rarely controls.","summary":"Case reports have described occasional responses of NUT carcinoma to checkpoint inhibitors despite its low mutation burden. This Northwestern University pilot gives cemiplimab to fifteen patients with metastatic or unresectable disease and measures safety and clinical activity. It is recruiting.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07050186","url":"https://clinicaltrials.gov/study/NCT07050186"}],"tags":["owner-request"],"related":[],"cancers":["nut-carcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07050186","phase":"2","setting":"Incurable metastatic or unresectable NUT carcinoma: single-arm open-label pilot of the PD-1 antibody cemiplimab; started August 2025, 15 planned","sponsor":"Northwestern University","started":"2025-08-15","startedType":"actual","enrolled":15,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06790602","kind":"trial","name":"Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma","aka":["SWITCH"],"tldr":"A phase 2 trial in pancreatic cancer, run by University of California, San Diego, now recruiting.","summary":"Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma is a phase 2, interventional study registered as NCT06790602 by University of California, San Diego, with a registry enrolment figure of 43 participants, started 2026-05-06 and due to reach its primary completion in 2028-07. Interventions recorded: Cemiplimab Plus Gemcitabine. Conditions listed: Pancreatic Ductal Adenocarcinoma (mPDAC). Primary outcome: Overall survival. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed pancreatic ductal adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06790602","url":"https://clinicaltrials.gov/study/NCT06790602"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06790602","phase":"2","setting":"A Single-arm, Open-label, Phase II Trial of Cemiplimab Plus Gemcitabine as Second-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma Harboring SWItch/Sucrose Non-Fermentable (SWI/SNF) Alterations.","sponsor":"University of California, San Diego","started":"2026-05-06","startedType":"actual","enrolled":43,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07224022","kind":"trial","name":"Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer","aka":["NACho"],"tldr":"A phase 2 trial of cemiplimab in colorectal cancer, run by John Strickler, M.D., not yet recruiting.","summary":"Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer is a phase 2, interventional study registered as NCT07224022 by John Strickler, M.D., with a registry enrolment figure of 24 participants, started 2026-10-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]. Conditions listed: Colon Cancer. Primary outcome: Feasibility of treatment with cemiplimab and fianlimab before surgery; Safety of treatment with cemiplimab and fianlimab before surgery. Colorectal eligibility wording from the registry: \"Histologically and/or cytologically documented adenocarcinoma of the colon\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07224022","url":"https://clinicaltrials.gov/study/NCT07224022"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07224022","phase":"2","setting":"NACho: A Study of Neo-Adjuvant Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer","sponsor":"John Strickler, M.D.","started":"2026-10-01","startedType":"estimated","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06205836","kind":"trial","name":"Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of cemiplimab and fianlimab in colorectal cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, now recruiting.","summary":"Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer is a phase 2, interventional study registered as NCT06205836 by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, with a registry enrolment figure of 44 participants, started 2024-06-13 and due to reach its primary completion in 2030-05. Interventions recorded: Cemiplimab; Fianlimab. Conditions listed: Colorectal Cancer. Primary outcome: Complete Response Rate. Colorectal eligibility wording from the registry: \"* Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06205836","url":"https://clinicaltrials.gov/study/NCT06205836"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab","fianlimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06205836","phase":"2","setting":"Evaluating a Surgical-Sparing Approach Using Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","started":"2024-06-13","startedType":"actual","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06427460","kind":"trial","name":"Central-boost Ablative Radiation Therapy for Solid Tumors (CBART)","aka":["CBART"],"tldr":"A phase 2 trial in pancreatic cancer, run by Changhai Hospital, now recruiting.","summary":"Central-boost Ablative Radiation Therapy for Solid Tumors (CBART) is a phase 2, interventional study registered as NCT06427460 by Changhai Hospital, with a registry enrolment figure of 67 participants, started 2024-05-12 and due to reach its primary completion in 2025-06-30. Interventions recorded: Central-boost ablative dose delivered by stereotactic body radiation therapy. Conditions listed: Pancreatic Cancer. Primary outcome: One-year local control will be determined.. Pancreatic eligibility wording from the registry: \"* Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06427460","url":"https://clinicaltrials.gov/study/NCT06427460"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06427460","phase":"2","setting":"Central-boost Ablative Radiation Therapy for Large Tumors or Tumors Adjacent to Organs at Risk","sponsor":"Changhai Hospital","started":"2024-05-12","startedType":"estimated","enrolled":67,"enrolledBasis":"registry","outcomes":[]},{"id":"cepheus","kind":"trial","name":"CEPHEUS","aka":[],"tldr":"CEPHEUS extended the quadruplet advantage to patients who do not have a transplant.","summary":"CEPHEUS, trial NCT03652064 sponsored by Janssen and reported in 2024, extended the quadruplet advantage to newly diagnosed myeloma patients who do not have a transplant, adding daratumumab to bortezomib, lenalidomide and dexamethasone. It randomised 395 transplant-ineligible or transplant-deferred patients and met its primary endpoint of MRD negativity, with a clear progression-free survival benefit at 54 months, and it was approved in 2025 alongside IMROZ-era labelling. OnCo links it to multiple myeloma, daratumumab, bortezomib, lenalidomide, the quadruplet pairing and the CEPHEUS paper. It is notable for using MRD negativity as its main endpoint, and whether regulators accept that surrogate more widely is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03652064","url":"https://clinicaltrials.gov/study/NCT03652064"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-transplant-ineligible"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["daratumumab","bortezomib","lenalidomide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03652064","phase":"3","setting":"Newly diagnosed transplant-ineligible or -deferred myeloma: Dara-VRd vs VRd","sponsor":"Janssen","result":"MRD-neg 60.9% vs 39.4%; PFS HR 0.57.","started":"2018-11-06","startedType":"actual","yearReported":2024,"enrolled":395,"enrolledBasis":"registry","outcomes":[{"endpoint":"MRD negativity (10⁻⁵)","primary":true,"unit":"%","arms":[{"name":"Dara-VRd","n":197,"value":60.9},{"name":"VRd","n":198,"value":39.4}],"p":"<0.0001","source":"https://doi.org/10.1038/s41591-024-03485-7"},{"endpoint":"Progression-free survival at 54 months","unit":"%","arms":[{"name":"Dara-VRd","value":68.1},{"name":"VRd","value":49.5}],"hr":0.57,"ci":[0.41,0.79],"source":"https://doi.org/10.1038/s41591-024-03485-7"}]},{"id":"nct05959356","kind":"trial","name":"Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer","aka":["CEIL"],"tldr":"A phase 2 trial in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT05959356 by Sun Yat-sen University, with a registry enrolment figure of 198 participants, started 2023-11-09 and due to reach its primary completion in 2026-12-31. Interventions recorded: Cetuximab + Envafolimab + mFOLFOXIRI; Cetuximab + mFOLFOX6. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Progression free survival. Colorectal eligibility wording from the registry: \"* Patients have histologically or cytologically confirmed RAS and BRAF wild-type, MSS metastatic colorectal adenocarcinoma (mCRC), excluding appendiceal and anal cancers\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05959356","url":"https://clinicaltrials.gov/study/NCT05959356"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05959356","phase":"2","setting":"Cetuximab and Envafolimab Plus mFOLFOXIRI Versus Cetuximab Plus mFOLFOX6 as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer: A Randomized Controlled Phase II Trial (CEIL)","sponsor":"Sun Yat-sen University","started":"2023-11-09","startedType":"actual","enrolled":198,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05962502","kind":"trial","name":"Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy","aka":[],"tldr":"A phase 2 trial of cetuximab and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy is a phase 2, interventional study registered as NCT05962502 by Sun Yat-sen University, with a registry enrolment figure of 54 participants, started 2023-08-24 and due to reach its primary completion in 2025-03-30. Interventions recorded: Cetuximab and irinotecan. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Objective response rate (ORR). Colorectal eligibility wording from the registry: \"Histologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05962502","url":"https://clinicaltrials.gov/study/NCT05962502"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["cetuximab","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05962502","phase":"2","setting":"A Single-arm, Open-label, Phase II Clinical Study of Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy","sponsor":"Sun Yat-sen University","started":"2023-08-24","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06547203","kind":"trial","name":"Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study","aka":[],"tldr":"A phase 2 trial of cetuximab, toripalimab and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study is a phase 2, interventional study registered as NCT06547203 by Sun Yat-sen University, with a registry enrolment figure of 34 participants, started 2024-07-18 and due to reach its primary completion in 2026-07-30. Interventions recorded: Cetuximab; Toripalimab; Irinotecan. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06547203","url":"https://clinicaltrials.gov/study/NCT06547203"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["cetuximab","toripalimab","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06547203","phase":"2","setting":"Negative Ultraselection of Patients With RAS/BRAF Wild-type Refractory Right-Sided Metastatic Colorectal Cancer Receiving Cetuximab in Combination With Toripalimab and Irinotecan: A Phase II, Single-arm Study","sponsor":"Sun Yat-sen University","started":"2024-07-18","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07555938","kind":"trial","name":"Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma","aka":["CEVOLUTION"],"tldr":"A phase 3 trial testing Cevostamab in multiple myeloma, now recruiting.","summary":"Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma is a phase 3 interventional study registered as NCT07555938, led by Hoffmann-La Roche, and recruiting on the registry. Official title: A Phase III, Randomised, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Patients With Multiple Myeloma Who Have Received One to Three Prior Lines of Therapy. Planned enrolment is 380 participants (estimated). The study started in 2026-06-23 and primary completion is expected in 2028-10-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07555938","url":"https://clinicaltrials.gov/study/NCT07555938"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["cevostamab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07555938","phase":"3","setting":"A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Patients With Multiple Myeloma Who Have Received One to Three Prior Lines of Therapy","sponsor":"Hoffmann-La Roche","started":"2026-06-23","startedType":"actual","enrolled":380,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05251714","kind":"trial","name":"CFI-402257, a Potent and Selective TTK Inhibitor, in Solid Tumors and With Fulvestrant in Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of Fulvestrant in advanced solid tumours, run by Treadwell Therapeutics, Inc, active and no longer recruiting.","summary":"CFI-402257, a Potent and Selective TTK Inhibitor, in Solid Tumors and With Fulvestrant in Breast Cancer is a phase 1/2 interventional study registered as NCT05251714 by Treadwell Therapeutics, Inc, with 44 participants enrolled, started 2022-05-27 and due to reach its primary completion in 2026-08. Interventions recorded: CFI-402257 and Fulvestrant.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05251714","url":"https://clinicaltrials.gov/study/NCT05251714"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["fulvestrant"],"companies":["treadwell-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05251714","phase":"1/2","setting":"A Dose-confirming Study of CFI-402257 as a Single Agent in Advanced Solid Tumors and in Combination With Fulvestrant in Patients With ER+/HER2- Advanced Breast Cancer After Disease Progression on Prior CDK4/6 and Endocrine Therapy","sponsor":"Treadwell Therapeutics, Inc","started":"2022-05-27","startedType":"actual","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06665087","kind":"trial","name":"CGA Guided Ultrafractionated RT and First-line Systemic Treatment in Elderly or Frail Patients with MCRC","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"CGA Guided Ultrafractionated RT and First-line Systemic Treatment in Elderly or Frail Patients with MCRC is a phase 2, interventional study registered as NCT06665087 by Fudan University, with a registry enrolment figure of 110 participants, started 2024-11 and due to reach its primary completion in 2027-11. Interventions recorded: Ultrafractionated RT and CGA Guided systemic treatment.; Ultrafractionated Radiotherapy; PD-1 antibody; Chemotherapy (Fluorouracil); Chemotherapy (Raltitrexed); Chemotherapy (Oxaliplatin); Chemotherapy (CPT-11); Targeted Therapy (anti-VEGF); Targeted Therapy (anti-EGFR). Conditions listed: Colon Cancer; Rectal Cancer. Primary outcome: Progression Free Survival. Colorectal eligibility wording from the registry: \"metastatic colorectal cancer;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06665087","url":"https://clinicaltrials.gov/study/NCT06665087"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06665087","phase":"2","setting":"Comprehensive Geriatric Assessment (CGA) Guided Ultrafractionated Radiotherapy and First-line Systemic Treatment in Elderly or Frail Patients with Metastatic Colorectal Cancer","sponsor":"Fudan University","started":"2024-11","startedType":"estimated","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06652412","kind":"trial","name":"CGA Guided Ultrafractionated RT and Systemic Treatment in Elderly or Frail Patients with Inoperable Localized CRC","aka":[],"tldr":"A phase 2 trial of sintilimab, fluorouracil (5-FU), raltitrexed, fOLFOX (5-FU, leucovorin, oxaliplatin) and other drugs in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"CGA Guided Ultrafractionated RT and Systemic Treatment in Elderly or Frail Patients with Inoperable Localized CRC is a phase 2, interventional study registered as NCT06652412 by Fudan University, with a registry enrolment figure of 124 participants, started 2024-11 and due to reach its primary completion in 2027-11. Interventions recorded: Ultrafractionated RT and CGA Guided systemic treatment.; data prospectively collected; Ultrafractionated Radiotherapy; Sintilimab; Fluorouracil; Raltitrexed; Oxaliplatin; Irinotecan (CPT-11). Conditions listed: Colon Cancer; Rectal Cancer. Primary outcome: Complete response (CR) rate. Colorectal eligibility wording from the registry: \"Pathologically confirmed Colorectal adenocarcinoma;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06652412","url":"https://clinicaltrials.gov/study/NCT06652412"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["sintilimab","fluorouracil","raltitrexed","folfox","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06652412","phase":"2","setting":"Comprehensive Geriatric Assessment (CGA) Guided Ultrafractionated Radiotherapy and Systemic Treatment in Elderly or Frail Patients with Inoperable Localized Colorectal Cancer","sponsor":"Fudan University","started":"2024-11","startedType":"estimated","enrolled":124,"enrolledBasis":"registry","outcomes":[]},{"id":"chaarted","kind":"trial","name":"CHAARTED (E3805)","aka":[],"tldr":"The first trial to show chemotherapy at the start of hormone therapy prolongs life in metastatic prostate cancer.","summary":"CHAARTED, ECOG-ACRIN trial E3805, NCT00309985, reported in 2015, was the first trial to show that giving docetaxel at the start of hormone therapy prolongs life in metastatic hormone-sensitive prostate cancer. It randomised 790 men to androgen deprivation with or without docetaxel and met its primary overall survival endpoint, but in long-term follow-up the benefit was confined to men with high-volume disease. OnCo links it to prostate cancer, docetaxel and Christopher J. Sweeney, and the result was replicated by arm C of the STAMPEDE platform, with the concentration of benefit in high-volume disease shaping how that distinction is used. Whether chemotherapy still earns its place now that triplet regimens and PSMA radioligands have entered this setting is the open question. Docetaxel has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT00309985","url":"https://clinicaltrials.gov/study/NCT00309985"},{"label":"CHAARTED (New England Journal of Medicine 2015)","url":"https://doi.org/10.1056/NEJMoa1503747"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":["ecog-acrin"],"institutions":[],"pathways":[],"terms":[],"trials":["getug-afu-15","stampede","rtog-0521"],"people":["christopher-sweeney"],"bottlenecks":[],"keyPapers":["paper-chaarted-nejm-2015"],"journals":[],"dependsOn":[],"notes":["CHAARTED randomised 790 men, median age 63, to androgen deprivation with or without docetaxel 75 mg/m2 every 3 weeks for six cycles. At a median 28.9 months, median overall survival was 13.6 months longer with the combination, 57.6 against 44.0 months. A PSA below 0.2 ng/mL at 12 months was reached by 27.7 against 16.8 percent (p<0.001). In the combination group grade 3 or 4 febrile neutropenia occurred in 6.2 percent, grade 3 or 4 infection with neutropenia in 2.3 percent and grade 3 sensory and motor neuropathy in 0.5 percent each (New England Journal of Medicine 2015).","GETUG-AFU 15, with 385 men, had tested the same question first and found nothing (hazard ratio 1.01). The difference is sample size and metastatic volume, and the pair is the standard example in prostate cancer of a negative trial that was simply too small."],"nct":"NCT00309985","phase":"3","setting":"Metastatic hormone-sensitive prostate cancer: ADT + docetaxel vs ADT","sponsor":"ECOG-ACRIN","result":"OS HR 0.61 overall; high-volume HR 0.63; low-volume no benefit.","started":"2006-09-26","startedType":"actual","yearReported":2015,"enrolled":790,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"ADT + docetaxel","n":397,"value":57.6},{"name":"ADT alone","n":393,"value":44}],"hr":0.61,"ci":[0.47,0.8],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1503747"},{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Androgen deprivation with docetaxel","value":57.6},{"name":"Androgen deprivation alone","value":44}],"hr":0.61,"ci":[0.47,0.8],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1503747"},{"endpoint":"Time to biochemical, symptomatic or radiographic progression (median)","unit":"months","arms":[{"name":"Androgen deprivation with docetaxel","value":20.2},{"name":"Androgen deprivation alone","value":11.7}],"hr":0.61,"ci":[0.51,0.72],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1503747"}],"replication":"Replicated by STAMPEDE arm C; benefit concentrated in high-volume disease."},{"id":"challenge","kind":"trial","name":"CHALLENGE (CCTG CO.21)","aka":[],"tldr":"The first randomised trial to show that a coached exercise programme after cancer treatment reduces recurrence and death, in colon cancer.","summary":"889 patients across Canada, Australia, UK, Israel and the US were randomised within 2-6 months of completing adjuvant chemotherapy to a structured exercise programme delivered by physical activity consultants (behavioural support sessions and supervised exercise, tapering over three years, targeting an increase of 10 MET-hours/week) or to health-education materials. Median follow-up 7.9 years. Disease-free survival at 5 years 80.3% vs 73.9% (HR 0.72, 95% CI 0.55-0.94); overall survival at 8 years 90.3% vs 83.2% (HR 0.63, 95% CI 0.43-0.94). Physical functioning and VO2 improved in the exercise arm; musculoskeletal adverse events were more common (18.5% vs 11.5%). The effect size is comparable with adding oxaliplatin to fluoropyrimidine adjuvant therapy. Limitations: one disease, open-label, participants were relatively fit volunteers, and the intervention required a trained workforce.","status":"positive","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT00819208","url":"https://clinicaltrials.gov/study/NCT00819208"},{"label":"Courneya et al. (NEJM 2025)","url":"https://doi.org/10.1056/NEJMoa2502760"}],"tags":[],"related":["idea-exercise-as-adjuvant","idea-bio2-exercise-reimbursement"],"cancers":["colorectal"],"sections":["nutrition-lifestyle"],"technologies":["structured-exercise-survivorship","exercise-oncology"],"targets":[],"drugs":["folfox"],"companies":["cctg"],"institutions":["princess-margaret"],"pathways":[],"terms":["met-hours","energy-balance","efs","os"],"trials":["idea-collaboration","mosaic"],"people":["kerry-courneya","christopher-booth"],"bottlenecks":["b-survivorship","b-prevention-adoption"],"keyPapers":["paper-challenge-exercise-nejm-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00819208","phase":"3","setting":"Resected stage III or high-risk stage II colon cancer after adjuvant chemotherapy: 3-year structured exercise programme vs health-education materials","sponsor":"Canadian Cancer Trials Group","result":"DFS HR 0.72; OS HR 0.63; 8-year OS 90.3% vs 83.2%.","started":"2009-06-02","startedType":"actual","yearReported":2025,"enrolled":889,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Structured exercise","n":445,"value":80.3},{"name":"Health education","n":444,"value":73.9}],"hr":0.72,"ci":[0.55,0.94],"p":"0.02","source":"https://doi.org/10.1056/NEJMoa2502760"},{"endpoint":"Overall survival at 8 years","unit":"%","arms":[{"name":"Structured exercise","value":90.3},{"name":"Health education","value":83.2}],"hr":0.63,"ci":[0.43,0.94],"source":"https://doi.org/10.1056/NEJMoa2502760"}],"replication":"None yet; CHALLENGE-design trials in breast and prostate cancer are being planned. Consistent with decades of cohort data on physical activity and colon cancer survival."},{"id":"chart-lung","kind":"trial","name":"CHART","aka":["Continuous Hyperfractionated Accelerated Radiotherapy","CHART lung trial"],"tldr":"A British radiotherapy schedule, invented at Mount Vernon, that squeezed a six-week course into twelve days and cut the risk of death by about a quarter.","summary":"Michele Saunders and Stanley Dische reasoned that tumour cells repopulate during a conventional six-week radiotherapy course, so they built a schedule that gave the whole dose in twelve consecutive days, three fractions a day, weekends included. The trial entered 563 patients through 13 centres and randomised them 3 to 2 to CHART or conventional radiotherapy.\n\nCHART reduced the relative risk of death by 24 percent, lifting two-year survival from 20 percent to 29 percent (p = 0.004). In squamous cell carcinoma, which was 82 percent of the trial, the reduction was 34 percent and two-year survival went from 19 percent to 33 percent. Severe dysphagia in the first three months was commoner with CHART (19 percent against 3 percent) but there was no important difference in other morbidity. The mature analysis confirmed a 22 percent reduction in the relative risk of death and a 21 percent reduction in local progression, and found a 24 percent reduction in the relative risk of metastasis, which the authors read as evidence that better local control prevents spread. The schedule was logistically hard for departments to run, and the UK kept iterating on it with CHART-ED and INCH.","status":"positive","asOf":"2026-09-25","links":[{"label":"Lancet 1997","url":"https://europepmc.org/article/MED/9250182"},{"label":"Radiotherapy and Oncology 1999 (mature results)","url":"https://europepmc.org/article/MED/10577699"}],"tags":["uk","radiotherapy","lung"],"related":[],"cancers":["nsclc","lung-cancer","lung-squamous-cell-carcinoma"],"sections":["radiation"],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":["mount-vernon-cancer-centre"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Non-small-cell lung cancer treated with radical radiotherapy: 54 Gy in 36 fractions of 1.5 Gy given three times a day, six hours apart, over 12 consecutive days including weekends, against conventional 60 Gy in 30 fractions over six weeks","sponsor":"Medical Research Council and the Cancer Research Campaign, run from Mount Vernon Hospital","result":"24 percent reduction in the relative risk of death and an absolute two-year survival gain of nine percentage points, from 20 to 29 percent (p = 0.004); in squamous cancers a 34 percent reduction and a 14-point gain.","yearReported":1997,"enrolled":563,"enrolledBasis":"randomised","enrolledNote":"563 patients were entered by 13 centres between April 1990 and March 1995 and randomised 3 to 2.","outcomes":[{"endpoint":"Two-year overall survival","primary":true,"unit":"percent","arms":[{"name":"CHART","value":29},{"name":"Conventional radiotherapy","value":20}],"hr":0.76,"ci":[0.63,0.92],"p":"0.004","source":"https://europepmc.org/article/MED/9250182"}]},{"id":"checkmate-017","kind":"trial","name":"CheckMate 017","aka":[],"tldr":"The first trial to show that a PD-1 antibody beats chemotherapy in lung cancer, and it did so in squamous disease, for which almost nothing had worked.","summary":"Squamous non-small-cell lung cancer that has progressed after platinum chemotherapy had almost no options: docetaxel gave a median survival of six months and heavy toxicity. CheckMate 017 randomised 272 such patients to nivolumab 3 mg/kg every two weeks or docetaxel 75 mg/m2 every three weeks, with overall survival as the primary endpoint.\n\nMedian overall survival was 9.2 months (95 percent confidence interval 7.3 to 13.3) with nivolumab against 6.0 months (5.1 to 7.3) with docetaxel, a 41 percent reduction in the risk of death (hazard ratio 0.59, 0.44 to 0.79). Response rate and progression-free survival also favoured nivolumab, and the effect held regardless of PD-L1 expression level, which is unusual and specific to the squamous population.\n\nThe FDA approved nivolumab for squamous non-small-cell lung cancer in 2015 on this trial. In England NICE TA655 (21 October 2020) recommends nivolumab for advanced squamous disease after chemotherapy. CheckMate 017 and CheckMate 057, published months apart, are the pair that made checkpoint inhibition standard second-line care in lung cancer before it moved to first line.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01642004","url":"https://clinicaltrials.gov/study/NCT01642004"},{"label":"CheckMate 017 (New England Journal of Medicine 2015)","url":"https://doi.org/10.1056/NEJMoa1504627"},{"label":"NICE TA655: nivolumab for advanced squamous non-small-cell lung cancer after chemotherapy","url":"https://www.nice.org.uk/guidance/ta655"}],"tags":[],"related":[],"cancers":["lung-squamous-cell-carcinoma","nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":["pd1","pdl1"],"drugs":["nivolumab","docetaxel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["immune-checkpoint","tps","pd-l1-testing"],"trials":["checkmate-057","oak"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01642004","phase":"3","setting":"Advanced squamous non-small-cell lung cancer progressing during or after first-line chemotherapy: nivolumab 3 mg/kg every two weeks versus docetaxel 75 mg/m2 every three weeks, with overall survival as the primary endpoint","sponsor":"Bristol-Myers Squibb","result":"Median overall survival 9.2 against 6.0 months (hazard ratio 0.59, 95 percent confidence interval 0.44 to 0.79), independent of PD-L1 level.","started":"2012-10-16","startedType":"actual","yearReported":2015,"enrolled":272,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab","n":135,"value":9.2},{"name":"Docetaxel","n":137,"value":6}],"hr":0.59,"ci":[0.44,0.79],"source":"https://doi.org/10.1056/NEJMoa1504627"}],"replication":"CheckMate 057 (non-squamous), OAK (atezolizumab) and KEYNOTE-010 (pembrolizumab) all reproduced the second-line survival benefit against docetaxel."},{"id":"checkmate-025","kind":"trial","name":"CheckMate 025","aka":[],"tldr":"CheckMate 025 was the trial that brought immunotherapy to kidney cancer: nivolumab helped people live longer than everolimus after anti-angiogenic drugs had failed, with fewer side effects.","summary":"CheckMate 025 randomised 821 patients with advanced clear cell renal cell carcinoma who had received one or two prior anti-angiogenic regimens to nivolumab or to everolimus, then the standard second-line drug. The primary endpoint was overall survival.\n\nNivolumab lengthened overall survival and produced more objective responses than everolimus, regardless of PD-L1 expression, with fewer grade 3 to 4 adverse events and better quality of life. It was approved in the United States in November 2015, the first checkpoint inhibitor in kidney cancer, and the combinations of nivolumab with ipilimumab or cabozantinib that followed (CheckMate 214 and 9ER) moved immunotherapy into first line.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01668784","url":"https://clinicaltrials.gov/study/NCT01668784"}],"tags":["subtype-trials"],"related":[],"cancers":["clear-cell-rcc","rcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","everolimus"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["robert-motzer"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01668784","phase":"3","setting":"Advanced clear cell renal cell carcinoma after one or two anti-angiogenic therapies: nivolumab against everolimus","sponsor":"Bristol Myers Squibb","result":"Nivolumab improved overall survival and response rate over everolimus in previously treated clear cell renal cell carcinoma; approved in November 2015.","started":"2012-10-09","startedType":"actual","yearReported":2015,"enrolled":821,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab 3 mg/kg","value":25,"note":"98.5% CI for the hazard ratio; 821 randomised 1:1"},{"name":"Everolimus 10 mg","value":19.6}],"hr":0.73,"ci":[0.57,0.93],"p":"0.002","source":"https://doi.org/10.1056/nejmoa1510665"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Nivolumab 3 mg/kg","value":25},{"name":"Everolimus 10 mg","value":5}],"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1510665"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Nivolumab 3 mg/kg","value":4.6},{"name":"Everolimus 10 mg","value":4.4}],"hr":0.88,"ci":[0.75,1.03],"p":"0.11","source":"https://doi.org/10.1056/nejmoa1510665"},{"endpoint":"Grade 3-4 treatment-related adverse events","unit":"%","arms":[{"name":"Nivolumab 3 mg/kg","value":19},{"name":"Everolimus 10 mg","value":37}],"source":"https://doi.org/10.1056/nejmoa1510665"}]},{"id":"checkmate-026","kind":"trial","name":"CheckMate 026","aka":[],"tldr":"The trial that showed a PD-1 antibody can fail in the first line if the PD-L1 threshold is set too low, and the reason the 50 percent cut-off exists.","summary":"KEYNOTE-024 and CheckMate 026 asked the same question at nearly the same time and got opposite answers. KEYNOTE-024 used pembrolizumab with a PD-L1 tumour proportion score threshold of 50 percent; CheckMate 026 used nivolumab with a threshold of 1 percent for entry and 5 percent for the primary analysis.\n\nAmong the 423 patients with PD-L1 expression of 5 percent or more, median progression-free survival was 4.2 months with nivolumab against 5.9 months with chemotherapy (hazard ratio 1.15, 95 percent confidence interval 0.91 to 1.45, p=0.25), and median overall survival was 14.4 against 13.2 months (hazard ratio 1.02, 0.80 to 1.30). Sixty percent of the chemotherapy arm crossed over to nivolumab. Treatment-related adverse events of any grade occurred in 71 percent on nivolumab and 92 percent on chemotherapy, and grade 3 or 4 events in 18 against 51 percent.\n\nThe failure is usually explained by the threshold and by an imbalance that put more patients with poor prognostic features in the nivolumab arm. Whatever the cause, CheckMate 026 is why single-agent PD-1 blockade in the first line is restricted to high PD-L1 expression, and why nivolumab's first-line indication came only later, with ipilimumab in CheckMate 227 and with chemotherapy in CheckMate 9LA.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02041533","url":"https://clinicaltrials.gov/study/NCT02041533"},{"label":"CheckMate 026 (New England Journal of Medicine 2017)","url":"https://doi.org/10.1056/NEJMoa1613493"}],"tags":[],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","companion-diagnostic","platinum"],"targets":["pd1","pdl1"],"drugs":["nivolumab","carboplatin","cisplatin"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["tps","pd-l1-testing"],"trials":["keynote-024-189","checkmate-227","checkmate-9la"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02041533","phase":"3","setting":"Untreated stage IV or recurrent non-small-cell lung cancer with PD-L1 on 1 percent or more of tumour cells: nivolumab 3 mg/kg every two weeks versus platinum-based chemotherapy, with progression-free survival in the PD-L1 5 percent or more population as the primary endpoint and crossover permitted","sponsor":"Bristol-Myers Squibb","result":"Median progression-free survival 4.2 against 5.9 months (hazard ratio 1.15, p=0.25) and overall survival 14.4 against 13.2 months (hazard ratio 1.02): the primary endpoint was not met.","started":"2014-03-27","startedType":"actual","yearReported":2017,"enrolled":541,"enrolledBasis":"randomised","enrolledNote":"423 patients with PD-L1 expression of 5 percent or more formed the primary analysis population; the registry figure counts all randomised patients.","outcomes":[{"endpoint":"Progression-free survival (PD-L1 5 percent or more)","primary":true,"unit":"months","arms":[{"name":"Nivolumab","value":4.2},{"name":"Platinum-based chemotherapy","value":5.9}],"hr":1.15,"ci":[0.91,1.45],"p":"0.25","source":"https://doi.org/10.1056/NEJMoa1613493"},{"endpoint":"Overall survival (PD-L1 5 percent or more)","unit":"months","arms":[{"name":"Nivolumab","value":14.4},{"name":"Platinum-based chemotherapy","value":13.2}],"hr":1.02,"ci":[0.8,1.3],"source":"https://doi.org/10.1056/NEJMoa1613493"}]},{"id":"checkmate-057","kind":"trial","name":"CheckMate 057","aka":[],"tldr":"Showed that a PD-1 antibody also beats chemotherapy in the commoner, non-squamous form of lung cancer, and that PD-L1 staining predicts how much.","summary":"CheckMate 057 randomised 582 patients with non-squamous non-small-cell lung cancer that had progressed during or after platinum doublet chemotherapy to nivolumab 3 mg/kg every two weeks (292) or docetaxel 75 mg/m2 every three weeks (290).\n\nMedian overall survival was 12.2 months (95 percent confidence interval 9.7 to 15.0) with nivolumab against 9.4 months (8.1 to 10.7) with docetaxel (hazard ratio for death 0.73, 96 percent confidence interval 0.59 to 0.89, p=0.002). One-year survival was 51 against 39 percent and 18-month survival 39 against 23 percent. Response was 19 against 12 percent (p=0.02). Median progression-free survival favoured docetaxel (2.3 against 4.2 months), but the one-year progression-free rate favoured nivolumab (19 against 8 percent): the crossing curves are the classic signature of immunotherapy, where a minority does very well and the median hides it. The benefit was greater at higher PD-L1 expression thresholds of 1, 5 and 10 percent, unlike in the squamous population of CheckMate 017.\n\nThe FDA approved nivolumab for non-squamous disease later in 2015. In England NICE TA713 (7 July 2021) recommends nivolumab for advanced non-squamous disease after chemotherapy.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01673867","url":"https://clinicaltrials.gov/study/NCT01673867"},{"label":"CheckMate 057 (New England Journal of Medicine 2015)","url":"https://doi.org/10.1056/NEJMoa1507643"},{"label":"NICE TA713: nivolumab for advanced non-squamous non-small-cell lung cancer after chemotherapy","url":"https://www.nice.org.uk/guidance/ta713"}],"tags":[],"related":[],"cancers":["lung-adenocarcinoma","nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":["pd1","pdl1"],"drugs":["nivolumab","docetaxel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["immune-checkpoint","tps","pd-l1-testing"],"trials":["checkmate-017","oak"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01673867","phase":"3","setting":"Advanced non-squamous non-small-cell lung cancer progressing during or after platinum doublet chemotherapy: nivolumab 3 mg/kg every two weeks versus docetaxel 75 mg/m2 every three weeks, with overall survival as the primary endpoint","sponsor":"Bristol-Myers Squibb","result":"Median overall survival 12.2 against 9.4 months (hazard ratio 0.73, p=0.002); progression-free survival crossed, favouring docetaxel at the median and nivolumab at one year.","started":"2012-11-02","startedType":"actual","yearReported":2015,"enrolled":582,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab","n":292,"value":12.2},{"name":"Docetaxel","n":290,"value":9.4}],"hr":0.73,"ci":[0.59,0.89],"p":"0.002","source":"https://doi.org/10.1056/NEJMoa1507643"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Nivolumab","n":292,"value":2.3},{"name":"Docetaxel","n":290,"value":4.2}],"source":"https://doi.org/10.1056/NEJMoa1507643"}],"replication":"OAK and KEYNOTE-010 reproduced the second-line survival benefit with atezolizumab and pembrolizumab."},{"id":"checkmate-067","kind":"trial","name":"CheckMate 067","aka":[],"tldr":"The trial with the longest immunotherapy follow-up: about half of patients on the combination are alive at 10 years.","summary":"CheckMate 067, trial NCT01844505 sponsored by Bristol Myers Squibb and reported in 2015 with ten-year results in the New England Journal of Medicine, is the trial with the longest immunotherapy follow-up: about half of patients on nivolumab plus ipilimumab for untreated advanced melanoma are alive at ten years when melanoma-specific survival is counted. It randomised 945 patients to the combination, nivolumab alone or ipilimumab alone, met its co-primary progression-free survival endpoint, and established that immunotherapy can produce durable cures. Who needs the ipilimumab component and its toxicity remains the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT01844505","url":"https://clinicaltrials.gov/study/NCT01844505"}],"tags":[],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["dirk-schadendorf","jedd-wolchok","paolo-ascierto","michael-postow","f-stephen-hodi","james-larkin"],"bottlenecks":[],"keyPapers":["paper-checkmate-067-10-year-nejm-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01844505","phase":"3","setting":"Untreated advanced melanoma: nivolumab + ipilimumab vs nivolumab vs ipilimumab","sponsor":"BMS","result":"10-year OS 43% vs 37% vs 19%.","started":"2013-06-11","startedType":"actual","yearReported":2015,"enrolled":945,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 10 years","unit":"%","arms":[{"name":"Nivolumab + ipilimumab","n":314,"value":43},{"name":"Nivolumab","n":316,"value":37},{"name":"Ipilimumab","n":315,"value":19}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2407417"},{"endpoint":"Median overall survival","unit":"months","arms":[{"name":"Nivolumab + ipilimumab","value":71.9},{"name":"Nivolumab","value":36.9},{"name":"Ipilimumab","value":19.9}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2407417"},{"endpoint":"Melanoma-specific survival at 10 years","unit":"%","arms":[{"name":"Nivolumab + ipilimumab","value":52},{"name":"Nivolumab","value":44},{"name":"Ipilimumab","value":23}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2407417"},{"endpoint":"Progression-free survival (co-primary)","primary":true,"unit":"months","arms":[{"name":"Nivolumab + ipilimumab","value":11.5,"note":"HR for combination vs ipilimumab"},{"name":"Nivolumab","value":6.9},{"name":"Ipilimumab","value":2.9}],"hr":0.42,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1504030"}],"replication":"Replicated by CheckMate 069 (phase 2) and consistent with KEYNOTE-006 for single-agent PD-1; the longest immunotherapy follow-up in any solid tumour."},{"id":"checkmate-141","kind":"trial","name":"CheckMate 141","aka":[],"tldr":"The first immunotherapy to extend survival in head and neck cancer, in patients who had progressed on platinum within six months.","summary":"CheckMate 141, trial NCT02105636 sponsored by Bristol Myers Squibb and reported in 2016, was the first immunotherapy to extend survival in head and neck cancer, in patients whose disease had progressed on platinum within six months. It randomised 361 patients to nivolumab or investigator's choice of methotrexate, docetaxel or cetuximab, met its primary overall survival endpoint with a durable tail at two years, and preserved quality of life where chemotherapy worsened it, leading to FDA approval in November 2016. OnCo links it to head and neck squamous cell carcinoma, PD-1 as a target and nivolumab, and KEYNOTE-040 with pembrolizumab showed a concordant, borderline survival benefit. Whether the minority with durable benefit can be identified in advance remains the open question for second-line immunotherapy.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02105636","url":"https://clinicaltrials.gov/study/NCT02105636"},{"label":"NEJM 2016","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1602252"}],"tags":[],"related":[],"cancers":["head-and-neck","oropharyngeal-cancer","oral-cavity-cancer","recurrent-metastatic-hnscc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02105636","phase":"3","setting":"Platinum-refractory recurrent or metastatic HNSCC: nivolumab vs investigator's choice (methotrexate, docetaxel, or cetuximab)","sponsor":"BMS","result":"OS 7.5 vs 5.1 months; HR 0.70.","started":"2014-05-29","startedType":"actual","yearReported":2016,"enrolled":361,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab","value":7.5},{"name":"Investigator's choice","value":5.1}],"hr":0.7,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1602252"}],"replication":"KEYNOTE-040 (pembrolizumab) showed a concordant, borderline OS benefit."},{"id":"checkmate-142","kind":"trial","name":"CheckMate 142","aka":[],"tldr":"The trial that first showed checkpoint immunotherapy works in mismatch-repair deficient bowel cancer, and that adding a second antibody makes it work better.","summary":"CheckMate 142 is the multi-cohort phase 2 that established immunotherapy in mismatch-repair deficient metastatic colorectal cancer. In the nivolumab-with-ipilimumab dMMR cohort of 119 patients, 76 percent of whom had received two or more previous systemic therapies, the investigator-assessed objective response rate was 55 percent (95% CI 45.2 to 63.8) and disease control for at least twelve weeks 80 percent; median duration of response was not reached and 94 percent of responses were continuing at data cutoff. Progression-free survival was 76 percent at nine months and 71 percent at twelve, and overall survival 87 and 85 percent. Grade 3 to 4 treatment-related events affected 32 percent. The microsatellite-stable cohorts were the mirror image: a later report of nivolumab, ipilimumab and cobimetinib in 30 patients with MSS or proficient mismatch repair disease found an objective response rate of 3 percent and median overall survival 8.2 months, and concluded that the regimen should not be pursued. CheckMate 142 led to the 2017 and 2018 accelerated approvals and set up KEYNOTE-177 and CheckMate 8HW.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02060188","url":"https://clinicaltrials.gov/study/NCT02060188"},{"label":"CheckMate 142: durable clinical benefit with nivolumab plus ipilimumab in dMMR metastatic colorectal cancer (Journal of Clinical Oncology 2018)","url":"https://doi.org/10.1200/JCO.2017.76.9901"},{"label":"CheckMate 142: nivolumab, ipilimumab and cobimetinib in MSS metastatic colorectal cancer (ESMO Gastrointestinal Oncology 2026)","url":"https://doi.org/10.1016/j.esmogo.2026.100334"}],"tags":[],"related":[],"cancers":["colorectal","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","ctla4","mek"],"drugs":["nivolumab","ipilimumab","cobimetinib"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["msi","cold-vs-hot"],"trials":["keynote-177","checkmate-8hw","imblaze370"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02060188","phase":"2","setting":"Recurrent or metastatic colorectal cancer, MSI-high and non-MSI-high cohorts: nivolumab alone or with ipilimumab, and later cohorts adding cobimetinib, daratumumab or relatlimab","sponsor":"Bristol Myers Squibb","result":"dMMR nivolumab plus ipilimumab cohort: objective response 55 percent, twelve-month overall survival 85 percent. MSS cohort with cobimetinib: objective response 3 percent.","started":"2014-03-12","startedType":"actual","yearReported":2018,"enrolled":385,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (dMMR, nivolumab plus ipilimumab)","primary":true,"unit":"percent","arms":[{"name":"Nivolumab plus ipilimumab","n":119,"value":55}],"ci":[45.2,63.8],"source":"https://doi.org/10.1200/JCO.2017.76.9901"},{"endpoint":"Objective response rate (MSS, nivolumab, ipilimumab and cobimetinib)","unit":"percent","arms":[{"name":"Nivolumab, ipilimumab and cobimetinib","n":30,"value":3}],"source":"https://doi.org/10.1016/j.esmogo.2026.100334"}],"replication":"KEYNOTE-177 and CheckMate 8HW confirmed the dMMR effect in randomised phase 3 trials; the MSS cohorts agree with IMblaze370."},{"id":"checkmate-143","kind":"trial","name":"CheckMate 143","aka":[],"tldr":"CheckMate 143 was the first large randomised test of an immune checkpoint drug in glioblastoma. When the tumour came back, nivolumab kept patients alive no longer than bevacizumab.","summary":"CheckMate 143, trial NCT02017717 sponsored by BMS, randomised 369 patients with glioblastoma at first recurrence after radiotherapy and temozolomide, open-label, to nivolumab 3 mg/kg or bevacizumab 10 mg/kg every two weeks. Median overall survival, the primary endpoint, was 9.8 versus 10.0 months (HR 1.04, 95% CI 0.83-1.30), 12-month survival was 42% in both arms, and the objective response rate was higher with bevacizumab (23.1% versus 7.8%). Published by Reardon and colleagues in JAMA Oncology in 2020. It is one of three negative phase 3 trials of nivolumab in glioblastoma, with CheckMate 498 and CheckMate 548 in newly diagnosed disease.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02017717","url":"https://clinicaltrials.gov/study/NCT02017717"},{"label":"Reardon et al., Effect of nivolumab vs bevacizumab in patients with recurrent glioblastoma: the CheckMate 143 phase 3 randomized clinical trial (JAMA Oncology 2020)","url":"https://doi.org/10.1001/jamaoncol.2020.1024"}],"tags":[],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["nivolumab","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":["cold-vs-hot","blood-brain-barrier"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-reardon-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02017717","phase":"3","setting":"Glioblastoma at first recurrence after radiotherapy and temozolomide: nivolumab vs bevacizumab","sponsor":"BMS","result":"OS 9.8 vs 10.0 months, HR 1.04 (95% CI 0.83-1.30); no benefit.","started":"2014-02-07","startedType":"actual","yearReported":2020,"enrolled":369,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, first recurrence of glioblastoma","primary":true,"unit":"months","arms":[{"name":"Nivolumab","n":184,"value":9.8,"note":"Not significant"},{"name":"Bevacizumab","n":185,"value":10}],"hr":1.04,"ci":[0.83,1.3],"p":"0.76","source":"https://doi.org/10.1001/jamaoncol.2020.1024"}],"replication":"Consistent with CheckMate 498 and 548 in newly diagnosed disease: three negative randomised trials of PD-1 blockade in glioblastoma."},{"id":"checkmate-204","kind":"trial","name":"CheckMate 204","aka":[],"tldr":"CheckMate 204 showed that the nivolumab and ipilimumab combination can shrink melanoma deposits in the brain in more than half of people whose brain metastases are not yet causing symptoms, so many can delay or avoid brain radiotherapy.","summary":"CheckMate 204 was a single-arm phase 2 trial of nivolumab plus ipilimumab in melanoma patients with at least one untreated brain metastasis measuring 0.5 to 3 centimetres. Brain metastases had been excluded from the pivotal immunotherapy trials, so whether the combination worked inside the skull was unknown.\n\nIn the 94 asymptomatic patients of the first report (NEJM 2018) the rate of intracranial clinical benefit was 57 percent, with complete responses in 26 percent, and intracranial and extracranial responses were concordant. Responses were durable at three years of follow-up. The smaller cohort of symptomatic patients or those needing steroids responded far less often, which is why symptomatic lesions are still treated with radiosurgery or surgery first.\n\nThe trial, with the Australian ABC study, changed the sequence for melanoma brain metastases: asymptomatic patients are offered the immunotherapy doublet first and radiosurgery is reserved for lesions that progress.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02320058","url":"https://clinicaltrials.gov/study/NCT02320058"},{"label":"NEJM 2018","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1805453"},{"label":"3-year follow-up, Lancet Oncology 2021","url":"https://doi.org/10.1016/S1470-2045(21)00545-3"}],"tags":[],"related":[],"cancers":["advanced-melanoma","secondary-brain-tumours","melanoma"],"sections":[],"technologies":["radiosurgery-srs"],"targets":["pd1","ctla4"],"drugs":["nivolumab","ipilimumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["brain-metastases"],"trials":[],"people":["hussein-tawbi"],"bottlenecks":[],"keyPapers":["paper-checkmate-204-n-engl-j-med-2018","paper-checkmate-204-lancet-oncol-2021-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02320058","phase":"2","setting":"Melanoma with untreated brain metastases: nivolumab plus ipilimumab, asymptomatic cohort and a smaller symptomatic cohort","sponsor":"BMS","result":"Intracranial clinical benefit 57% and complete response 26% in the asymptomatic cohort.","started":"2015-03-05","startedType":"actual","yearReported":2018,"enrolled":119,"enrolledBasis":"registry","outcomes":[{"endpoint":"Intracranial clinical benefit rate (asymptomatic cohort)","primary":true,"unit":"%","arms":[{"name":"Nivolumab + ipilimumab","n":94,"value":57}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1805453"}],"replication":"The ABC trial (Anti-PD1 Brain Collaboration, Australia) found a similar intracranial response rate for the same combination."},{"id":"checkmate-205","kind":"trial","name":"CheckMate 205","aka":[],"tldr":"Established PD-1 blockade in relapsed Hodgkin lymphoma with ~70% response rates and seeded the frontline nivolumab-AVD idea.","summary":"CheckMate 205, trial NCT02181738 sponsored by Bristol Myers Squibb and reported in 2016, established PD-1 blockade with nivolumab in relapsed or refractory classical Hodgkin lymphoma after autologous transplant, with responses in about seventy percent of patients, and seeded the frontline nivolumab-AVD idea. Across 243 patients in cohorts A to C the response rate was 69 percent with complete responses in 16 percent and durable progression-free intervals, leading to accelerated approval in May 2016, while cohort D tested nivolumab-AVD in the frontline with very high complete response rates, the basis for SWOG S1826. OnCo links it to Hodgkin lymphoma, nivolumab and the pairing of PD-1 blockade with AVD chemotherapy. Whether PD-1 blockade can replace chemotherapy entirely in some patients is the question its cohort D opened.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02181738","url":"https://clinicaltrials.gov/study/NCT02181738"}],"tags":[],"related":[],"cancers":["hodgkin-lymphoma","relapsed-refractory-hodgkin-lymphoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02181738","phase":"2","setting":"Relapsed/refractory classical Hodgkin lymphoma after autologous transplant: nivolumab (cohorts A-C); cohort D nivolumab-AVD frontline","sponsor":"BMS","result":"ORR 69%.","started":"2014-08-12","startedType":"actual","yearReported":2016,"enrolled":243,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Nivolumab","n":243,"value":69}],"source":"https://doi.org/10.1200/JCO.2017.76.0793"}]},{"id":"checkmate-214","kind":"trial","name":"CheckMate 214","aka":[],"tldr":"CheckMate 214 is the trial that brought dual immunotherapy to kidney cancer, with a survival advantage still visible eight years later and a fifth of patients in long-term remission.","summary":"CheckMate 214, trial NCT02231749 sponsored by Bristol Myers Squibb and reported in 2018, brought dual immunotherapy to kidney cancer, with a survival advantage still visible eight years later and a fifth of patients in long-term remission. It randomised 1,096 patients with untreated advanced clear-cell renal cell carcinoma to nivolumab plus ipilimumab or sunitinib, met its primary overall survival endpoint in intermediate and poor-risk patients with durable benefit at eight years, produced complete responses in about an eighth of patients, many lasting off treatment, and led to FDA approval in April 2018, while favourable-risk patients did not gain survival. It is the comparator for every later first-line trial, and no head-to-head between IO-IO and IO-TKI exists, which is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02231749","url":"https://clinicaltrials.gov/study/NCT02231749"}],"tags":[],"related":[],"cancers":["rcc","clear-cell-rcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab","sunitinib"],"companies":[],"institutions":[],"pathways":[],"terms":["imdc-risk"],"trials":[],"people":["robert-motzer","laurence-albiges"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02231749","phase":"3","setting":"Untreated advanced clear-cell RCC: nivolumab + ipilimumab vs sunitinib","sponsor":"BMS","result":"8-year OS HR 0.72 (ITT), 0.69 (intermediate/poor risk).","started":"2014-10-16","startedType":"actual","yearReported":2018,"enrolled":1096,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, intermediate/poor risk (8-year follow-up)","primary":true,"arms":[{"name":"Nivolumab + ipilimumab","n":425},{"name":"Sunitinib","n":422}],"hr":0.69,"ci":[0.59,0.81],"source":"https://www.annalsofoncology.org/article/S0923-7534(24)01516-3/fulltext"},{"endpoint":"Overall survival, ITT (8-year follow-up)","arms":[{"name":"Nivolumab + ipilimumab","n":550},{"name":"Sunitinib","n":546}],"hr":0.72,"ci":[0.62,0.83],"source":"https://doi.org/10.1056/NEJMoa1712126"}],"replication":"IO-doublet benefit replicated by IO-TKI trials (KEYNOTE-426, CheckMate 9ER, CLEAR) with different partners; no head-to-head between IO-IO and IO-TKI exists."},{"id":"checkmate-227","kind":"trial","name":"CheckMate 227","aka":[],"tldr":"CheckMate 227 showed that a chemotherapy-free pair of immunotherapy drugs, nivolumab and ipilimumab, helped people with advanced lung cancer live longer than chemotherapy alone, which made it a first-line option for tumours with any PD-L1 expression.","summary":"CheckMate 227 was a large open-label phase 3 programme in previously untreated advanced non-small-cell lung cancer without EGFR or ALK alterations. Part 1 randomised patients by PD-L1 status to nivolumab plus low-dose ipilimumab, nivolumab alone or nivolumab plus chemotherapy (PD-L1 of 1 percent or more), or to nivolumab plus ipilimumab or nivolumab plus chemotherapy (PD-L1 below 1 percent), each against platinum doublet chemotherapy. The co-primary endpoints were progression-free survival in tumours with high mutational burden and overall survival in PD-L1-positive tumours.\n\nNivolumab plus ipilimumab lengthened overall survival compared with chemotherapy in patients whose tumours expressed PD-L1 at 1 percent or more, and the benefit also appeared in the PD-L1-negative group. The tumour mutational burden endpoint did not translate into an overall survival difference. The combination was approved in the United States in May 2020 for PD-L1-positive disease, and the long-term follow-up has shown a tail of durable survivors in both PD-L1 groups.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02477826","url":"https://clinicaltrials.gov/study/NCT02477826"}],"tags":["subtype-trials"],"related":[],"cancers":["pdl1-high-nsclc","nsclc","lung-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["matthew-hellmann"],"bottlenecks":[],"keyPapers":["paper-checkmate-227-n-engl-j-med-2018","paper-checkmate-227-int-j-clin-oncol-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02477826","phase":"3","setting":"Untreated stage IV or recurrent non-small-cell lung cancer without EGFR or ALK alterations: nivolumab plus ipilimumab, nivolumab plus chemotherapy or nivolumab alone against platinum chemotherapy, analysed by PD-L1 expression","sponsor":"Bristol Myers Squibb","result":"Nivolumab plus ipilimumab improved overall survival over chemotherapy in PD-L1-positive advanced non-small-cell lung cancer; approved in the United States in May 2020.","started":"2015-08-05","startedType":"actual","yearReported":2019,"enrolled":2747,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, PD-L1 >=1%","primary":true,"unit":"months","arms":[{"name":"Nivolumab + ipilimumab","value":17.1},{"name":"Chemotherapy","value":14.9}],"p":"0.007","source":"https://doi.org/10.1056/nejmoa1910231"},{"endpoint":"Overall survival at 2 years, PD-L1 >=1%","unit":"%","arms":[{"name":"Nivolumab + ipilimumab","value":40},{"name":"Chemotherapy","value":32.8}],"source":"https://doi.org/10.1056/nejmoa1910231"},{"endpoint":"Overall survival, PD-L1 <1%","unit":"months","arms":[{"name":"Nivolumab + ipilimumab","value":17.2},{"name":"Chemotherapy","value":12.2}],"source":"https://doi.org/10.1056/nejmoa1910231"},{"endpoint":"Overall survival, all randomised patients","unit":"months","arms":[{"name":"Nivolumab + ipilimumab","value":17.1},{"name":"Chemotherapy","value":13.9}],"source":"https://doi.org/10.1056/nejmoa1910231"},{"endpoint":"Duration of response, PD-L1 >=1%","unit":"months","arms":[{"name":"Nivolumab + ipilimumab","value":23.2},{"name":"Chemotherapy","value":6.2}],"source":"https://doi.org/10.1056/nejmoa1910231"},{"endpoint":"Grade 3-4 treatment-related adverse events","unit":"%","arms":[{"name":"Nivolumab + ipilimumab","value":32.8},{"name":"Chemotherapy","value":36}],"source":"https://doi.org/10.1056/nejmoa1910231"}]},{"id":"checkmate-238","kind":"trial","name":"CheckMate 238","aka":[],"tldr":"CheckMate 238 showed that a year of nivolumab after melanoma surgery prevents more relapses than the older drug ipilimumab, with far fewer serious side effects, and it made PD-1 blockade the standard adjuvant treatment.","summary":"CheckMate 238 randomised 906 patients with completely resected stage IIIB, IIIC or IV melanoma to one year of nivolumab or of high-dose ipilimumab, the adjuvant standard set by EORTC 18071. It was designed to show that PD-1 blockade could match or beat ipilimumab's relapse-free survival benefit with less toxicity.\n\nTwelve-month recurrence-free survival was 70.5 percent with nivolumab against 60.8 percent with ipilimumab (hazard ratio 0.65), and grade 3 or 4 treatment-related adverse events occurred in 14 percent against 46 percent. At four years recurrence-free survival was 51.7 percent against 41.2 percent, while overall survival did not differ, partly because most relapsing patients in both arms went on to effective immunotherapy.\n\nNivolumab was approved as adjuvant therapy in December 2017 on this trial. With KEYNOTE-054 it established a year of anti-PD-1 antibody as the adjuvant standard for stage III melanoma, later extended to stage II by KEYNOTE-716 and CheckMate 76K and challenged by the neoadjuvant results of SWOG S1801 and NADINA.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02388906","url":"https://clinicaltrials.gov/study/NCT02388906"},{"label":"NEJM 2017","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1709030"},{"label":"4-year follow-up, Lancet Oncology 2020","url":"https://doi.org/10.1016/S1470-2045(20)30494-0"}],"tags":[],"related":[],"cancers":["stage-iii-melanoma","melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","ctla4"],"drugs":["nivolumab","ipilimumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","efs"],"trials":[],"people":["jeffrey-weber","james-larkin","paolo-ascierto"],"bottlenecks":[],"keyPapers":["paper-checkmate-238-nejm-2017","paper-checkmate-238-lancet-oncol-2020-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02388906","phase":"3","setting":"Resected stage IIIB, IIIC or IV melanoma: one year of adjuvant nivolumab versus ipilimumab 10 mg/kg","sponsor":"BMS","result":"12-month recurrence-free survival 70.5% vs 60.8% (HR 0.65); 4-year recurrence-free survival 51.7% vs 41.2%; no overall survival difference.","started":"2015-03-16","startedType":"actual","yearReported":2017,"enrolled":906,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free survival at 12 months","primary":true,"unit":"%","arms":[{"name":"Nivolumab","n":453,"value":70.5},{"name":"Ipilimumab 10 mg/kg","n":453,"value":60.8}],"hr":0.65,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1709030"},{"endpoint":"Recurrence-free survival at 4 years","unit":"%","arms":[{"name":"Nivolumab","n":453,"value":51.7},{"name":"Ipilimumab 10 mg/kg","n":453,"value":41.2}],"source":"https://doi.org/10.1016/S1470-2045(20)30494-0"}],"replication":"KEYNOTE-054 (pembrolizumab versus placebo) found a relapse-free survival benefit of the same size for PD-1 blockade after surgery."},{"id":"checkmate-274","kind":"trial","name":"CheckMate 274","aka":[],"tldr":"A year of nivolumab after bladder or upper-tract surgery reduces recurrence and, with long follow-up, extends life.","summary":"CheckMate 274, trial NCT02632409 sponsored by Bristol Myers Squibb and reported in 2021, showed that a year of adjuvant nivolumab after radical surgery for high-risk muscle-invasive urothelial carcinoma of the bladder or upper tract reduces recurrence and, with long follow-up, extends life. It randomised 709 patients to nivolumab or placebo, met its primary disease-free survival endpoint, and later showed an overall survival benefit that was larger in the bladder subset and durable at five years, leading to FDA approval in August 2021. OnCo links it to bladder cancer, nivolumab and Dean F. Bajorin. It now competes with perioperative approaches from NIAGARA and EV-303 and EV-304 and with ctDNA-guided adjuvant therapy, and where adjuvant nivolumab fits among them is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02632409","url":"https://clinicaltrials.gov/study/NCT02632409"},{"label":"5-year data","url":"https://www.urologytimes.com/view/checkmate-274-5-year-data-confirm-durable-benefit-with-nivolumab"}],"tags":[],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["dean-bajorin"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02632409","phase":"3","setting":"High-risk muscle-invasive urothelial carcinoma after radical surgery: adjuvant nivolumab 1 year vs placebo","sponsor":"BMS","result":"DFS HR 0.70; OS HR 0.83 (ITT), median 75 vs 50.1 months.","started":"2016-03-22","startedType":"actual","yearReported":2021,"enrolled":709,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab","n":353,"value":22},{"name":"Placebo","n":356,"value":10.9}],"hr":0.7,"ci":[0.57,0.85],"source":"https://ascopubs.org/doi/10.1200/JCO.24.00340"},{"endpoint":"Overall survival (ITT)","unit":"months","arms":[{"name":"Nivolumab","value":75},{"name":"Placebo","value":50.1}],"hr":0.83,"source":"https://doi.org/10.1056/NEJMoa2034442"}],"replication":"IMvigor010 (adjuvant atezolizumab, all-comers) was negative, but its ctDNA-positive subgroup led to IMvigor011, which was positive; AMBASSADOR (adjuvant pembrolizumab) improved DFS."},{"id":"checkmate-358","kind":"trial","name":"CheckMate 358","aka":[],"tldr":"CheckMate 358 gave the immunotherapy drug nivolumab to people with cancers caused by viruses; in Merkel cell carcinoma, a short course before surgery made the tumour disappear entirely in nearly half of those operated on, the first sign that immunotherapy could work before surgery in this skin cancer.","summary":"CheckMate 358 was a non-comparative open-label phase 1/2 programme in advanced cancers linked to viruses, including Merkel cell carcinoma (Merkel cell polyomavirus), cervical, vaginal and vulvar cancers and HPV-positive head and neck cancer (human papillomavirus), EBV-positive gastric cancer and nasopharyngeal cancer. Cohorts received nivolumab alone or combined with ipilimumab, relatlimab or daratumumab.\n\nThe most influential cohort gave two doses of nivolumab before surgery to patients with resectable Merkel cell carcinoma; a substantial share of those who underwent surgery had a pathological complete response, and these responses were durable. The cervical cohort showed activity for nivolumab in recurrent or metastatic disease. The Merkel results underpin the ongoing randomised trials of perioperative immunotherapy in this cancer.","status":"completed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02488759","url":"https://clinicaltrials.gov/study/NCT02488759"}],"tags":["subtype-trials"],"related":[],"cancers":["merkel-cell-carcinoma","skin-cancer","recurrent-metastatic-cervical-cancer","cervical"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sandra-dangelo"],"bottlenecks":[],"keyPapers":["paper-checkmate-358-j-clin-oncol-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02488759","phase":"1/2","setting":"Virus-associated cancers, including Merkel cell carcinoma, cervical, vaginal and vulvar cancers, HPV-positive head and neck cancer, EBV-positive gastric cancer and nasopharyngeal cancer: nivolumab alone or with ipilimumab or other agents, with a neoadjuvant Merkel cell cohort","sponsor":"Bristol Myers Squibb","result":"Neoadjuvant nivolumab produced pathological complete responses in a substantial share of resectable Merkel cell carcinomas, with durable responses; nivolumab also showed activity in recurrent cervical cancer.","started":"2015-10-13","startedType":"actual","yearReported":2020,"enrolled":578,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response, recurrent or metastatic Merkel cell carcinoma cohort","primary":true,"unit":"%","arms":[{"name":"Nivolumab","n":25,"value":60,"note":"95% CI 38.7 to 78.9"},{"name":"Nivolumab + ipilimumab","n":43,"value":58,"note":"95% CI 42.1 to 73"}],"source":"https://doi.org/10.1200/jco-24-02138"},{"endpoint":"Duration of response, Merkel cell carcinoma cohort","unit":"months","arms":[{"name":"Nivolumab","n":25,"value":60.6},{"name":"Nivolumab + ipilimumab","n":43,"value":25.9}],"source":"https://doi.org/10.1200/jco-24-02138"},{"endpoint":"Progression-free survival, Merkel cell carcinoma cohort","unit":"months","arms":[{"name":"Nivolumab","n":25,"value":21.3},{"name":"Nivolumab + ipilimumab","n":43,"value":8.4}],"source":"https://doi.org/10.1200/jco-24-02138"},{"endpoint":"Overall survival, Merkel cell carcinoma cohort","unit":"months","arms":[{"name":"Nivolumab","n":25,"value":80.7},{"name":"Nivolumab + ipilimumab","n":43,"value":29.8}],"source":"https://doi.org/10.1200/jco-24-02138"},{"endpoint":"Grade 3-4 treatment-related adverse events, Merkel cell carcinoma cohort","unit":"%","arms":[{"name":"Nivolumab","n":25,"value":28},{"name":"Nivolumab + ipilimumab","n":43,"value":47}],"source":"https://doi.org/10.1200/jco-24-02138"}]},{"id":"checkmate-498","kind":"trial","name":"CheckMate 498","aka":[],"tldr":"CheckMate 498 asked whether nivolumab could replace temozolomide in the glioblastoma patients who gain least from it. Patients given nivolumab lived a shorter time.","summary":"CheckMate 498, trial NCT02617589 sponsored by BMS, randomised 560 patients with newly diagnosed glioblastoma and an unmethylated MGMT promoter to standard radiotherapy (60 Gy) with nivolumab or with temozolomide. Median overall survival, the primary endpoint, was 13.4 months with nivolumab and 14.9 months with temozolomide (HR 1.31, 95% CI 1.09-1.58); median progression-free survival was 6.0 versus 6.2 months. Published by Omuro and colleagues in Neuro-Oncology (2023;25:123-134). It is one of three negative phase 3 trials of nivolumab in glioblastoma, with CheckMate 143 at recurrence and CheckMate 548 in MGMT-methylated disease.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02617589","url":"https://clinicaltrials.gov/study/NCT02617589"},{"label":"Omuro et al., Radiotherapy combined with nivolumab or temozolomide for newly diagnosed glioblastoma with unmethylated MGMT promoter: an international randomized phase III trial (Neuro-Oncology 2023)","url":"https://doi.org/10.1093/neuonc/noac099"}],"tags":[],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":["pd1"],"drugs":["nivolumab","temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":["mgmt","cold-vs-hot","blood-brain-barrier"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-omuro-neuro-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02617589","phase":"3","setting":"Newly diagnosed glioblastoma with unmethylated MGMT promoter: radiotherapy + nivolumab vs radiotherapy + temozolomide","sponsor":"BMS","result":"OS 13.4 vs 14.9 months, HR 1.31 (95% CI 1.09-1.58); worse with nivolumab.","started":"2016-03-01","startedType":"actual","yearReported":2023,"enrolled":560,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, MGMT-unmethylated glioblastoma","primary":true,"unit":"months","arms":[{"name":"Nivolumab + RT","n":280,"value":13.4,"note":"Favours temozolomide"},{"name":"Temozolomide + RT","n":280,"value":14.9}],"hr":1.31,"ci":[1.09,1.58],"p":"0.0037","source":"https://doi.org/10.1093/neuonc/noac099"}],"replication":"Consistent with CheckMate 143 and 548: three negative randomised trials of PD-1 blockade in glioblastoma."},{"id":"checkmate-548","kind":"trial","name":"CheckMate 548","aka":[],"tldr":"CheckMate 548 added nivolumab to standard radiotherapy and temozolomide in newly diagnosed glioblastoma and found no benefit. With CheckMate 143 and 498 it makes three large negative trials: the immunotherapy that transformed melanoma and lung cancer did nothing in glioblastoma.","summary":"CheckMate 548, trial NCT02667587 sponsored by BMS, randomised 716 patients with newly diagnosed glioblastoma and a methylated MGMT promoter to nivolumab or placebo added to radiotherapy and temozolomide. Median progression-free survival by blinded central review was 10.6 versus 10.3 months and median overall survival 28.9 versus 32.1 months (HR 1.1, 95% CI 0.9-1.3 for both); grade 3/4 treatment-related adverse events were more frequent with nivolumab (52.4% versus 33.6%). Published by Lim and colleagues in Neuro-Oncology (2022;24:1935-1949). Together with CheckMate 143 (recurrent) and CheckMate 498 (MGMT-unmethylated) it completes three negative phase 3 trials of PD-1 blockade in glioblastoma. Explanations: low mutational burden, T-cell exclusion behind the blood-brain barrier, steroid immunosuppression, systemic lymphopenia. Neoadjuvant PD-1 (Cloughesy 2019) showed immune activation and remains the only encouraging signal.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02667587","url":"https://clinicaltrials.gov/study/NCT02667587"},{"label":"Lim et al., Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter (Neuro-Oncology 2022)","url":"https://doi.org/10.1093/neuonc/noac116"}],"tags":[],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":["pd1"],"drugs":["nivolumab","temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":["mgmt","cold-vs-hot","blood-brain-barrier"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-lim-neuro-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02667587","phase":"3","setting":"Newly diagnosed glioblastoma with methylated MGMT promoter: nivolumab vs placebo added to radiotherapy and temozolomide","sponsor":"BMS","result":"OS 28.9 vs 32.1 months, HR 1.1 (95% CI 0.9-1.3); no PFS or OS benefit.","started":"2016-05-09","startedType":"actual","yearReported":2022,"enrolled":716,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, MGMT-methylated glioblastoma","primary":true,"unit":"months","arms":[{"name":"Nivolumab + RT + temozolomide","n":358,"value":28.9,"note":"Not significant"},{"name":"Placebo + RT + temozolomide","n":358,"value":32.1}],"hr":1.1,"ci":[0.92,1.32],"source":"https://doi.org/10.1093/neuonc/noac116"}],"replication":"Consistent with CheckMate 143 and 498: three negative randomised trials of PD-1 blockade in glioblastoma."},{"id":"checkmate-577","kind":"trial","name":"CheckMate 577","aka":[],"tldr":"A year of immunotherapy after surgery doubled the time before cancer returned in patients whose tumour had not fully responded to chemoradiation, though the survival gain did not reach significance.","summary":"CheckMate 577, trial NCT02743494 sponsored by Bristol Myers Squibb and reported in 2021, showed that a year of adjuvant nivolumab doubled the time before cancer returned in patients with oesophageal or gastro-oesophageal junction cancer whose tumour had not fully responded to neoadjuvant chemoradiation and surgery, though the survival gain did not reach significance. It randomised 794 patients with residual disease to nivolumab or placebo and met its primary disease-free survival endpoint, the basis of the 2021 FDA approval, while the final overall survival analysis at ASCO 2025 favoured nivolumab without statistical significance. It remains standard in NCCN and ESMO guidance, and whether a disease-free benefit without a survival benefit should be enough is the open question.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02743494","url":"https://clinicaltrials.gov/study/NCT02743494"},{"label":"Final OS, ASCO 2025","url":"https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4000"}],"tags":[],"related":[],"cancers":["esophageal","gastric","oesophageal-squamous-cell-carcinoma","oesophageal-adenocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":["cross"],"people":["ronan-kelly"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02743494","phase":"3","setting":"Resected oesophageal/GEJ cancer with residual disease after neoadjuvant chemoradiation: adjuvant nivolumab 1 year vs placebo","sponsor":"BMS","result":"DFS 22.4 vs 11.0 months (HR 0.69); OS 51.7 vs 35.3 months (HR 0.85, NS).","started":"2016-07-14","startedType":"actual","yearReported":2021,"enrolled":794,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab","n":532,"value":22.4},{"name":"Placebo","n":262,"value":11}],"hr":0.69,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2032125"},{"endpoint":"Overall survival (final)","unit":"months","arms":[{"name":"Nivolumab","n":532,"value":51.7},{"name":"Placebo","n":262,"value":35.3}],"hr":0.85,"ci":[0.7,1.04],"p":"0.1064","source":"https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4000"}],"replication":"Single phase 3; real-world matched cohorts show similar OS direction."},{"id":"checkmate-648","kind":"trial","name":"CheckMate 648","aka":[],"tldr":"Showed two immunotherapy options for squamous oesophageal cancer, including one with no chemotherapy at all, both extending survival.","summary":"CheckMate 648, trial NCT03143153 sponsored by Bristol Myers Squibb and reported in 2021, showed two immunotherapy options for first-line advanced oesophageal squamous cell carcinoma, nivolumab plus chemotherapy and a chemotherapy-free doublet of nivolumab plus ipilimumab, both extending survival. It randomised 970 patients across three arms and met its primary overall survival endpoint in PD-L1-positive patients for both regimens, with benefit in all randomised patients and durable separation confirmed at five-year follow-up in 2026, leading to FDA approval of both regimens in May 2022. OnCo links it to oesophageal cancer, PD-1 and CTLA-4 as targets, nivolumab, ipilimumab and Jaffer A. Ajani. Which patients are best served by avoiding chemotherapy altogether is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03143153","url":"https://clinicaltrials.gov/study/NCT03143153"},{"label":"5-year follow-up","url":"https://pubmed.ncbi.nlm.nih.gov/42575473/"}],"tags":[],"related":[],"cancers":["esophageal","oesophageal-squamous-cell-carcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","ctla4"],"drugs":["nivolumab","ipilimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jaffer-ajani"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03143153","phase":"3","setting":"First-line advanced oesophageal squamous cell carcinoma: nivolumab + chemotherapy, or nivolumab + ipilimumab (chemotherapy-free), vs chemotherapy","sponsor":"BMS","result":"PD-L1 ≥1%: OS 15.4 vs 9.1 months (nivo + chemo, HR 0.54); 13.7 vs 9.1 months (nivo + ipi, HR 0.64).","started":"2017-06-29","startedType":"actual","yearReported":2021,"enrolled":970,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, PD-L1 ≥1% (nivolumab + chemotherapy)","primary":true,"unit":"months","arms":[{"name":"Nivolumab + chemotherapy","value":15.4},{"name":"Chemotherapy","value":9.1}],"hr":0.54,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2111380"},{"endpoint":"Overall survival, PD-L1 ≥1% (nivolumab + ipilimumab)","unit":"months","arms":[{"name":"Nivolumab + ipilimumab","value":13.7},{"name":"Chemotherapy","value":9.1}],"hr":0.64,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2111380"}],"replication":"Consistent with KEYNOTE-590 and RATIONALE-306; the chemotherapy-free doublet is unique to this trial."},{"id":"checkmate-649","kind":"trial","name":"CheckMate 649","aka":[],"tldr":"The trial that added immunotherapy to first-line stomach cancer chemotherapy; at five years, 16% of patients with PD-L1-rich tumours were alive versus 6%.","summary":"CheckMate 649, trial NCT02872116 sponsored by Bristol Myers Squibb and reported in 2020, is the largest phase 3 in gastric cancer and the trial that added immunotherapy to first-line chemotherapy, with a durable minority of long-term survivors among patients with PD-L1-rich tumours at five years. It randomised 1,581 patients with HER2-negative gastric, gastro-oesophageal junction or oesophageal adenocarcinoma to nivolumab plus chemotherapy or chemotherapy and met its primary overall survival endpoint in the PD-L1 CPS 5 or higher population, with a smaller benefit in all randomised patients; the FDA approved it for all patients in 2021 while the EMA and many guidelines restrict it to CPS 5 or higher. Whether PD-L1-low patients gain anything is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02872116","url":"https://clinicaltrials.gov/study/NCT02872116"},{"label":"5-year follow-up, Annals of Oncology 2026","url":"https://www.annalsofoncology.org/article/S0923-7534(26)00059-1/fulltext"}],"tags":[],"related":[],"cancers":["gastric","gastric-pdl1-high","gastric-msi-high","esophageal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","pdl1"],"drugs":["nivolumab","capox","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":["cps"],"trials":[],"people":["kang-won-ki","jaffer-ajani","yelena-janjigian"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02872116","phase":"3","setting":"First-line HER2-negative advanced gastric/GEJ/oesophageal adenocarcinoma: nivolumab + chemotherapy vs chemotherapy","sponsor":"BMS","result":"CPS ≥5: OS 14.4 vs 11.1 months (HR 0.71); 5-year OS 16% vs 6%.","started":"2016-10-12","startedType":"actual","yearReported":2020,"enrolled":1581,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 2,031 participants (actual) across all three arms; the Lancet 2021 primary analysis concurrently randomised 1,581 patients to nivolumab plus chemotherapy or chemotherapy alone, leaving out the nivolumab plus ipilimumab arm.","outcomes":[{"endpoint":"Overall survival, PD-L1 CPS ≥5","primary":true,"unit":"months","arms":[{"name":"Nivolumab + chemotherapy","n":473,"value":14.4},{"name":"Chemotherapy","n":482,"value":11.1}],"hr":0.71,"ci":[0.61,0.81],"source":"https://www.annalsofoncology.org/article/S0923-7534(26)00059-1/fulltext"},{"endpoint":"Overall survival at 5 years, CPS ≥5","unit":"percent","arms":[{"name":"Nivolumab + chemotherapy","value":16},{"name":"Chemotherapy","value":6}],"source":"https://www.annalsofoncology.org/article/S0923-7534(26)00059-1/fulltext"}],"replication":"Replicated by KEYNOTE-859 (pembrolizumab), RATIONALE-305 (tislelizumab), and ORIENT-16 (sintilimab)."},{"id":"checkmate-743","kind":"trial","name":"CheckMate 743","aka":[],"tldr":"CheckMate 743 was the first immunotherapy trial to lengthen survival in mesothelioma, and gave the first new first-line option in 16 years.","summary":"CheckMate 743, trial NCT02899299 sponsored by Bristol Myers Squibb and reported in 2020, was the first immunotherapy trial to lengthen survival in unresectable pleural mesothelioma, giving the first new first-line option in sixteen years. It randomised 605 patients to nivolumab plus ipilimumab or platinum and pemetrexed, met its primary overall survival endpoint with a durable minority alive at five years and the largest benefit in non-epithelioid histology, and led to FDA approval in October 2020 with severe treatment-related events in about a third. OnCo links it to mesothelioma, nivolumab, ipilimumab, pemetrexed, the histology term, Paul Baas, Solange Peters and the pairing of histology with first-line choice. Whether epithelioid patients gain enough to justify dual immunotherapy over chemotherapy combinations is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02899299","url":"https://clinicaltrials.gov/study/NCT02899299"}],"tags":[],"related":[],"cancers":["mesothelioma","pleural-mesothelioma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab","pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":["epithelioid-vs-sarcomatoid"],"trials":[],"people":["paul-baas","solange-peters"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02899299","phase":"3","setting":"Unresectable pleural mesothelioma, first line: nivolumab + ipilimumab vs platinum-pemetrexed","sponsor":"BMS","result":"OS 18.1 vs 14.1 months, HR 0.74; 5-year OS 14% vs 6%.","started":"2016-11-29","startedType":"actual","yearReported":2020,"enrolled":605,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab + ipilimumab","n":303,"value":18.1},{"name":"Platinum + pemetrexed","n":302,"value":14.1}],"hr":0.74,"ci":[0.6,0.91],"p":"0.002","source":"https://pubmed.ncbi.nlm.nih.gov/33485464/"},{"endpoint":"5-year overall survival rate","unit":"%","arms":[{"name":"Nivolumab + ipilimumab","value":14},{"name":"Platinum + pemetrexed","value":6}],"hr":0.74,"ci":[0.62,0.88],"source":"https://ascopubs.org/doi/10.1200/JCO-25-01328"}],"replication":"Single phase 3; consistent direction in the phase 2 MAPS2 and INITIATE studies of second-line nivolumab-ipilimumab."},{"id":"checkmate-816","kind":"trial","name":"CheckMate 816","aka":[],"tldr":"CheckMate 816 was the first trial to show that immunotherapy before lung cancer surgery improves survival.","summary":"CheckMate 816, trial NCT02998528 sponsored by Bristol Myers Squibb and reported in 2022, was the first trial to show that immunotherapy before lung cancer surgery improves survival. It randomised 358 patients with resectable stage IB to IIIA non-small-cell lung cancer to three cycles of nivolumab plus platinum chemotherapy or chemotherapy alone, met both primary endpoints of pathologic complete response and event-free survival, showed an overall survival benefit in a 2025 update, and produced the first neoadjuvant-only immunotherapy approval in 2022. OnCo links it to the pCR and perioperative terms, to Tina Cascone, Jonathan Spicer, Patrick M. Forde and Valerie W. Rusch, and its event-free survival benefit was reproduced by KEYNOTE-671, AEGEAN, CheckMate 77T and NEOTORCH. Whether adding an adjuvant phase after neoadjuvant treatment adds anything is the open question.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT02998528","url":"https://clinicaltrials.gov/study/NCT02998528"}],"tags":[],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","pcr"],"trials":[],"people":["tina-cascone","jonathan-spicer","valerie-rusch","patrick-forde"],"bottlenecks":[],"keyPapers":["paper-checkmate-816-nejm-2022","paper-checkmate-816-n-engl-j-med-2025-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02998528","phase":"3","setting":"Resectable stage IB-IIIA NSCLC: neoadjuvant nivolumab + platinum chemotherapy (3 cycles) vs chemotherapy","sponsor":"BMS","result":"EFS HR 0.63; OS HR 0.72.","started":"2017-03-04","startedType":"actual","yearReported":2022,"enrolled":358,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 505 participants (actual) across all arms, including nivolumab plus ipilimumab; the NEJM 2022 primary analysis compared 179 patients randomised to nivolumab plus chemotherapy with 179 randomised to chemotherapy.","outcomes":[{"endpoint":"Pathologic complete response","primary":true,"unit":"%","arms":[{"name":"Nivolumab + chemotherapy","n":179,"value":24},{"name":"Chemotherapy","n":179,"value":2.2}],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2202170"},{"endpoint":"Event-free survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab + chemotherapy","value":31.6},{"name":"Chemotherapy","value":20.8}],"hr":0.63,"ci":[0.43,0.91],"p":"0.005","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2202170"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Nivolumab + chemotherapy","value":65},{"name":"Chemotherapy","value":55}],"hr":0.72,"ci":[0.52,0.99],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2502256"}],"replication":"Confirmed by the perioperative trials KEYNOTE-671, AEGEAN, CheckMate 77T, and NEOTORCH, which all reproduced the EFS benefit."},{"id":"checkmate-8hw","kind":"trial","name":"CheckMate 8HW","aka":[],"tldr":"Showed that a two-drug immunotherapy combination controls mismatch-repair-deficient bowel cancer for over four years on average, and beats immunotherapy alone.","summary":"First-line nivolumab + ipilimumab vs chemotherapy: PFS HR 0.21 (NEJM 2024); at 47 months' follow-up median PFS 54.1 vs 5.9 months. Across all lines, nivolumab + ipilimumab beat nivolumab alone on PFS (Lancet 2025, HR 0.62), the first phase 3 to show the CTLA-4 add-on matters in this setting. FDA approved the combination first line in April 2025. Overall survival is not yet mature.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04008030","url":"https://clinicaltrials.gov/study/NCT04008030"},{"label":"NEJM 2024","url":"https://www.nejm.org/doi/abs/10.1056/NEJMoa2402141"},{"label":"Lancet 2025","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02848-4/abstract"}],"tags":[],"related":[],"cancers":["colorectal","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","ctla4"],"drugs":["nivolumab","ipilimumab"],"companies":[],"institutions":[],"pathways":[],"terms":["msi"],"trials":["nct05855200"],"people":["thierry-andre","heinz-josef-lenz"],"bottlenecks":[],"keyPapers":["paper-overman-checkmate-142-nivolumab-dmmr-colorectal-lancet-oncol-2017","paper-le-mmr-deficiency-pd1-nejm-2015","paper-andre-checkmate-8hw-nivolumab-ipilimumab-nejm-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04008030","phase":"3","setting":"MSI-H/dMMR metastatic colorectal cancer, all lines: nivolumab + ipilimumab vs nivolumab vs chemotherapy","sponsor":"BMS","result":"First-line PFS 54.1 vs 5.9 months (HR 0.21); combination vs nivolumab PFS HR 0.62.","started":"2019-08-05","startedType":"actual","yearReported":2024,"enrolled":839,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival, first line","primary":true,"unit":"months","arms":[{"name":"Nivolumab + ipilimumab","n":202,"value":54.1},{"name":"Chemotherapy","n":101,"value":5.9}],"hr":0.21,"source":"https://dailynews.ascopubs.org/do/updated-checkmate-8hw-results-nivolumab-ipilimumab-shows-sustained-pfs-benefit-msi-h"},{"endpoint":"Progression-free survival, all lines: combination vs nivolumab","arms":[{"name":"Nivolumab + ipilimumab","n":296},{"name":"Nivolumab","n":286}],"hr":0.62,"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02848-4/abstract"}],"replication":"Consistent with KEYNOTE-177 for PD-1 monotherapy; the doublet-over-monotherapy result is so far unique to this trial."},{"id":"checkmate-915","kind":"trial","name":"CheckMate 915","aka":[],"tldr":"CheckMate 915 asked whether adding a low dose of ipilimumab to nivolumab after melanoma surgery would prevent more recurrences; it did not, and added toxicity, so single-agent PD-1 blockade remains the adjuvant standard.","summary":"Nivolumab plus ipilimumab is the most active combination in advanced melanoma, and CheckMate 915 tested whether a lower-toxicity version (ipilimumab 1 mg/kg every six weeks) would improve on nivolumab alone after complete resection of stage IIIB to IV melanoma. It randomised 1844 patients, with recurrence-free survival in the whole population and in PD-L1-low tumours as the dual primary endpoints.\n\nThe combination did not improve recurrence-free survival in either population and caused more treatment-related adverse events. Adjuvant nivolumab or pembrolizumab alone remain the standards, and later trials have tested relatlimab (RELATIVITY-098) and neoadjuvant approaches (NADINA) instead.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03068455","url":"https://clinicaltrials.gov/study/NCT03068455"}],"tags":["subtype-trials"],"related":[],"cancers":["stage-iii-melanoma","melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jeffrey-weber"],"bottlenecks":[],"keyPapers":["paper-checkmate-915-j-immunother-cancer-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03068455","phase":"3","setting":"Resected stage IIIB to IV melanoma: adjuvant nivolumab plus low-dose ipilimumab against nivolumab alone","sponsor":"Bristol Myers Squibb","result":"Nivolumab plus low-dose ipilimumab did not improve recurrence-free survival over nivolumab alone after resection of stage III to IV melanoma.","started":"2017-04-11","startedType":"actual","yearReported":2022,"enrolled":1844,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free survival, all randomised participants (registry results)","primary":true,"unit":"months","arms":[{"name":"Nivolumab + ipilimumab","note":"Median not reached"},{"name":"Nivolumab","note":"Median not reached"}],"hr":0.9,"ci":[0.78,1.04],"source":"https://clinicaltrials.gov/study/NCT03068455?tab=results"},{"endpoint":"Recurrence-free survival, PD-L1 expression below 1% (registry results)","primary":true,"unit":"months","arms":[{"name":"Nivolumab + ipilimumab","value":33.15,"note":"95% CI 22.21 to not reached"},{"name":"Nivolumab","value":27.63,"note":"95% CI 19.81 to not reached"}],"hr":0.92,"ci":[0.75,1.14],"source":"https://clinicaltrials.gov/study/NCT03068455?tab=results"}]},{"id":"checkmate-9dw","kind":"trial","name":"CheckMate 9DW","aka":[],"tldr":"Dual immune checkpoint blockade gave the longest median survival yet seen in a first-line liver cancer trial.","summary":"CheckMate 9DW, trial NCT04039607 sponsored by Bristol Myers Squibb and reported in 2024, showed that dual checkpoint blockade with nivolumab plus ipilimumab gives the longest median survival yet seen in a first-line liver cancer trial. It randomised 668 patients with unresectable hepatocellular carcinoma to the combination or to lenvatinib or sorafenib, met its primary overall survival endpoint, and produced a much higher response rate with far more durable responses, leading to FDA approval in April 2025, at the cost of more immune-related toxicity than single-agent regimens. OnCo links it to PD-1 and CTLA-4 as targets and to nivolumab and ipilimumab. Whether the extra toxicity is worth it for all patients, or whether a biomarker could pick those who need the CTLA-4 component, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04039607","url":"https://clinicaltrials.gov/study/NCT04039607"},{"label":"Lancet 2025","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00403-9/fulltext"}],"tags":[],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","ctla4"],"drugs":["nivolumab","ipilimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04039607","phase":"3","setting":"First-line unresectable HCC: nivolumab + ipilimumab vs lenvatinib or sorafenib","sponsor":"BMS","result":"OS 23.7 vs 20.6 months, HR 0.79; ORR 36% vs 13%.","started":"2019-09-30","startedType":"actual","yearReported":2024,"enrolled":732,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab + ipilimumab","n":335,"value":23.7},{"name":"Lenvatinib or sorafenib","n":333,"value":20.6}],"hr":0.79,"ci":[0.65,0.96],"p":"0.018","source":"https://doi.org/10.1016/S0140-6736(25)00403-9"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Nivolumab + ipilimumab","value":36},{"name":"Lenvatinib or sorafenib","value":13}],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(25)00403-9"}]},{"id":"checkmate-9er","kind":"trial","name":"CheckMate 9ER","aka":[],"tldr":"Nivolumab with cabozantinib doubled progression-free survival versus sunitinib and lengthened life, with quality of life preserved.","summary":"CheckMate 9ER, trial NCT03141177 sponsored by Bristol Myers Squibb and Exelixis and reported in 2020, showed that nivolumab with cabozantinib doubled progression-free survival versus sunitinib in untreated advanced clear-cell renal cell carcinoma and lengthened life, with quality of life preserved. It randomised 651 patients, met its primary progression-free survival endpoint, improved overall survival with the effect narrowing at the final four-year analysis, and led to FDA approval in January 2021; cabozantinib's MET and AXL activity is a proposed contributor. OnCo links it to renal cell carcinoma, nivolumab, cabozantinib, sunitinib, Robert J. Motzer, Toni K. Choueiri and James Larkin. Choosing between the IO-TKI doublets without head-to-head data is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03141177","url":"https://clinicaltrials.gov/study/NCT03141177"}],"tags":[],"related":[],"cancers":["rcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","cabozantinib","sunitinib"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["robert-motzer","james-larkin","toni-choueiri"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03141177","phase":"3","setting":"Untreated advanced clear-cell RCC: nivolumab + cabozantinib vs sunitinib","sponsor":"BMS / Exelixis","result":"PFS HR 0.51; OS HR 0.77 at ~4 years (46.5 vs 36.0 months).","started":"2017-07-23","startedType":"actual","yearReported":2020,"enrolled":701,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab + cabozantinib","n":323,"value":16.6},{"name":"Sunitinib","n":328,"value":8.3}],"hr":0.51,"ci":[0.41,0.64],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2026982"},{"endpoint":"Overall survival (final)","unit":"months","arms":[{"name":"Nivolumab + cabozantinib","value":46.5},{"name":"Sunitinib","value":36}],"hr":0.77,"ci":[0.63,0.95],"source":"https://doi.org/10.1056/NEJMoa2026982"}],"replication":"Consistent with other IO-TKI doublets; COSMIC-313 (adding cabozantinib to nivolumab-ipilimumab) improved PFS but not OS."},{"id":"checkmate-9la","kind":"trial","name":"CheckMate 9LA","aka":[],"tldr":"Used just two cycles of chemotherapy to cover the first weeks while dual immunotherapy takes effect, an answer to the criticism that immunotherapy alone is too slow for people with heavy disease.","summary":"CheckMate 227 had shown that nivolumab with ipilimumab beats chemotherapy in the first line, but the survival curves cross early: patients with a large tumour burden can progress before dual checkpoint blockade works. CheckMate 9LA tested a limited course of chemotherapy as a bridge. It randomised 719 of 1,150 enrolled patients at 103 hospitals in 19 countries between August 2017 and January 2019 to nivolumab 360 mg every three weeks with ipilimumab 1 mg/kg every six weeks plus two cycles of platinum doublet chemotherapy (361), or to four cycles of chemotherapy alone (358), stratified by histology, sex and PD-L1 expression.\n\nAt the preplanned interim analysis with a median 9.7 months of follow-up, median overall survival was 14.1 months (95 percent confidence interval 13.2 to 16.2) against 10.7 months (9.5 to 12.4), hazard ratio 0.69 (96.71 percent confidence interval 0.55 to 0.87, p=0.00065). With 3.5 months more follow-up it was 15.6 months (13.9 to 20.0) against 10.9.\n\nThe FDA approved the regimen in 2020. England is the exception: NICE TA724 (8 September 2021) does not recommend nivolumab with ipilimumab and two cycles of platinum doublet chemotherapy for untreated metastatic disease, so the regimen is not routinely funded there even though it is a standard option in the United States and much of Europe.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03215706","url":"https://clinicaltrials.gov/study/NCT03215706"},{"label":"CheckMate 9LA (Lancet Oncology 2021)","url":"https://doi.org/10.1016/S1470-2045(20)30641-0"},{"label":"NICE TA724: nivolumab with ipilimumab and chemotherapy for untreated metastatic non-small-cell lung cancer (not recommended)","url":"https://www.nice.org.uk/guidance/ta724"}],"tags":[],"related":[],"cancers":["nsclc","lung-squamous-cell-carcinoma","lung-adenocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":["pd1","ctla4"],"drugs":["nivolumab","ipilimumab","carboplatin","cisplatin","pemetrexed","paclitaxel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["immune-checkpoint","tps"],"trials":["checkmate-227","nct03164616"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03215706","phase":"3","setting":"Treatment-naive stage IV or recurrent non-small-cell lung cancer of any PD-L1 level: nivolumab 360 mg every three weeks with ipilimumab 1 mg/kg every six weeks plus two cycles of histology-based platinum doublet chemotherapy, versus four cycles of chemotherapy alone, with overall survival as the primary endpoint","sponsor":"Bristol-Myers Squibb","result":"Median overall survival 14.1 against 10.7 months at the interim analysis (hazard ratio 0.69, p=0.00065), and 15.6 against 10.9 months with longer follow-up.","started":"2017-08-24","startedType":"actual","yearReported":2020,"enrolled":719,"enrolledBasis":"randomised","enrolledNote":"1,150 patients were enrolled and 719 randomised; the registry figure counts enrolment.","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab, ipilimumab and two cycles of chemotherapy","n":361,"value":14.1},{"name":"Four cycles of chemotherapy","n":358,"value":10.7}],"hr":0.69,"ci":[0.55,0.87],"p":"0.00065","source":"https://doi.org/10.1016/S1470-2045(20)30641-0"}],"replication":"POSEIDON reproduced the idea with durvalumab, tremelimumab and chemotherapy (median overall survival 14.0 against 11.7 months, hazard ratio 0.77)."},{"id":"nct06280508","kind":"trial","name":"Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of adebrelimab, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, now recruiting.","summary":"Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer is a phase 2 interventional study registered as NCT06280508 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, with a registry enrolment figure of 40 participants, started 2024-03-01 and due to reach its primary completion in 2027-03-31. Interventions recorded: Adebrelimab, Apatinib, Gemcitabine, cisplatin. Conditions listed: Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06280508","url":"https://clinicaltrials.gov/study/NCT06280508"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["adebrelimab","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06280508","phase":"2","setting":"A Prospective, Single-arm Exploratory Trail of Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","started":"2024-03-01","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06037655","kind":"trial","name":"Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC","aka":["Modified"],"tldr":"A phase 2 trial of adebrelimab in gallbladder cancer and other biliary tract cancers, run by The First Affiliated Hospital with Nanjing Medical University, not yet recruiting.","summary":"Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC is a phase 2 interventional study registered as NCT06037655 by The First Affiliated Hospital with Nanjing Medical University, with a registry enrolment figure of 30 participants, started 2023-09-25 and due to reach its primary completion in 2026-03-31. Interventions recorded: Total Neoadjuvant Treatment. Conditions listed: Biliary Tract Neoplasms. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06037655","url":"https://clinicaltrials.gov/study/NCT06037655"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06037655","phase":"2","setting":"Gemcitabine/Cisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study","sponsor":"The First Affiliated Hospital with Nanjing Medical University","started":"2023-09-25","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06096844","kind":"trial","name":"Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial","aka":[],"tldr":"A phase 3 trial of carboplatin, nab-paclitaxel, paclitaxel / nab-paclitaxel, pembrolizumab and other drugs in lung cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial is a phase 3, randomised interventional study registered as NCT06096844 by National Cancer Institute (NCI), with a registry enrolment figure of 304 participants, started 2024-07-19 and due to reach its primary completion in 2039-04-01. Interventions recorded: Carboplatin; Computed Tomography; Magnetic Resonance Imaging; Nab-paclitaxel; Paclitaxel; Pembrolizumab; Pemetrexed; Positron Emission Tomography; Questionnaire Administration. Conditions listed: Advanced Lung Non-Small Cell Carcinoma; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8. Primary outcome: Overall survival (OS). Lung eligibility wording from the registry: \"* Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49%\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06096844","url":"https://clinicaltrials.gov/study/NCT06096844"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","nab-paclitaxel","paclitaxel","pembrolizumab","pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06096844","phase":"3","setting":"A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable Older Adult With Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study","sponsor":"National Cancer Institute (NCI)","started":"2024-07-19","startedType":"actual","enrolled":304,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07125391","kind":"trial","name":"Chemotherapy Combined With Propranolol Hydrochloride as Neoadjuvant Therapy for Advanced High-grade Serous Ovarian Cancer","aka":[],"tldr":"A phase 2 trial of Propranolol, Paclitaxel / nab-paclitaxel and Carboplatin in Ovarian cancer, run by Bai-Rong Xia, now recruiting.","summary":"Chemotherapy Combined With Propranolol Hydrochloride as Neoadjuvant Therapy for Advanced High-grade Serous Ovarian Cancer is a phase 2 interventional study registered as NCT07125391 by Bai-Rong Xia, with 136 participants planned, started 2025-06-20 and due to reach its primary completion in 2026-08-30. Interventions recorded: Propranolol Hydrochloride, Paclitaxel liposome, Carboplatin. Conditions recorded: Ovarian Cancer.\n\nLinked to the drug Propranolol because the registry names it among its interventions and Ovarian cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07125391","url":"https://clinicaltrials.gov/study/NCT07125391"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["propranolol-hemangeol","paclitaxel","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07125391","phase":"2","setting":"Chemotherapy Combined With Propranolol Hydrochloride as Neoadjuvant Therapy for Advanced High-grade Serous Ovarian Cancer: A Prospective, Multicenter, Phase II Clinical Study","sponsor":"Bai-Rong Xia","started":"2025-06-20","startedType":"actual","enrolled":136,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00024167","kind":"trial","name":"Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Docetaxel, Doxorubicin, Estramustine, Prednisone, Vinblastine and Dexamethasone in Prostate cancer, run by M.D. Anderson Cancer Center, recorded as terminated on the registry.","summary":"Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer is a phase 3 interventional study registered as NCT00024167 by M.D. Anderson Cancer Center, with 265 participants recorded, started 2002-04 and due to reach its primary completion in 2014-09. Interventions recorded: Docetaxel, Doxorubicin hydrochloride, Estramustine phosphate sodium, Ketoconazole, Prednisone, Vinblastine, Strontium chloride Sr 89, Dexamethasone. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Estramustine because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00024167","url":"https://clinicaltrials.gov/study/NCT00024167"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["docetaxel","doxorubicin","estramustine","prednisone","vinblastine","dexamethasone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00024167","phase":"3","setting":"A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy With or Without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer","sponsor":"M.D. Anderson Cancer Center","started":"2002-04","yearReported":2016,"enrolled":265,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival From Randomization","primary":true,"unit":"months","arms":[{"name":"Induction Treatment + Strontium-89","n":65,"value":24.2,"note":"95% CI 19.8 to 29.8; Figures from the ClinicalTrials.gov results section (first posted 2016-03-22), not from a publication"},{"name":"Induction Treatment + No Strontium-89","n":62,"value":22.8,"note":"95% CI 17.7 to 27.7"}],"source":"https://clinicaltrials.gov/study/NCT00024167?tab=results"}]},{"id":"nct01275677","kind":"trial","name":"Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer","aka":[],"tldr":"A phase 3 trial of Cyclophosphamide, Docetaxel, Doxorubicin, Paclitaxel / nab-paclitaxel, Trastuzumab and Trastuzumab biosimilars in Breast cancer, run by National Cancer Institute (NCI), completed.","summary":"Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer is a phase 3 interventional study registered as NCT01275677 by National Cancer Institute (NCI), with 3270 participants recorded, started 2011-02-08 and reaching its primary completion in 2017-07-31. Interventions recorded: Cyclophosphamide, Docetaxel, Doxorubicin, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Paclitaxel, Quality-of-Life Assessment, Trastuzumab. Conditions recorded: HER2/Neu Positive, Progesterone Receptor Positive, Recurrent Breast Carcinoma, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7.\n\nLinked to the drug Trastuzumab biosimilars because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01275677","url":"https://clinicaltrials.gov/study/NCT01275677"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cyclophosphamide","docetaxel","doxorubicin","paclitaxel","trastuzumab","trastuzumab-biosimilars"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01275677","phase":"3","setting":"A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women With Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer","sponsor":"National Cancer Institute (NCI)","started":"2011-02-08","startedType":"actual","yearReported":2020,"enrolled":3270,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Patients Alive and Free From Invasive Disease (IDFS)","primary":true,"unit":"%","arms":[{"name":"Arm I (Chemotherapy)","n":1602,"value":89.2,"note":"Figures from the ClinicalTrials.gov results section (first posted 2020-09-23), not from a publication"},{"name":"Arm II (Chemotherapy, Trastuzumab)","n":1598,"value":89.8}],"source":"https://clinicaltrials.gov/study/NCT01275677?tab=results"},{"endpoint":"Percentage of Patients Alive (Overall Survival)","unit":"%","arms":[{"name":"Arm I (Chemotherapy)","n":1603,"value":96.3,"note":"Figures from the ClinicalTrials.gov results section (first posted 2020-09-23), not from a publication"},{"name":"Arm II (Chemotherapy, Trastuzumab)","n":1602,"value":94.8}],"source":"https://clinicaltrials.gov/study/NCT01275677?tab=results"}]},{"id":"chhip","kind":"trial","name":"CHHiP","aka":[],"tldr":"CHHiP showed that four weeks of prostate radiotherapy in 3 Gy fractions is as effective as seven and a half weeks of conventional treatment, and 60 Gy in 20 fractions became the standard of care.","summary":"CHHiP randomised 3,216 men with localised prostate cancer to 74 Gy in 37 fractions, 60 Gy in 20 or 57 Gy in 19, delivered with intensity-modulated radiotherapy and short-course hormone therapy. Five-year biochemical or clinical failure-free survival was 88.3 percent with 74 Gy and 90.6 percent with 60 Gy, proving non-inferiority; 57 Gy did not. Late bowel and bladder effects were similar (Dearnaley and colleagues, Lancet Oncology 2016), and the 60 Gy schedule was adopted internationally.","status":"positive","asOf":"2026-09-16","links":[{"label":"ISRCTN97182923","url":"https://www.isrctn.com/ISRCTN97182923"},{"label":"Lancet Oncology 2016","url":"https://doi.org/10.1016/S1470-2045(16)30102-4"},{"label":"CHHiP 5-year outcomes (Lancet Oncology 2016)","url":"https://doi.org/10.1016/S1470-2045(16)30102-4"},{"label":"CHHiP radiotherapy quality assurance (Clinical Oncology 2019)","url":"https://doi.org/10.1016/j.clon.2019.05.009"},{"label":"ISRCTN registry ISRCTN97182923","url":"https://www.isrctn.com/ISRCTN97182923"}],"tags":["radiation-wave2"],"related":[],"cancers":["prostate","prostate-intermediate-risk","prostate-low-risk"],"sections":[],"technologies":["hypofractionated-radiotherapy","imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":["icr-london"],"pathways":[],"terms":["hypofractionation","alpha-beta-ratio","prostate-radiotherapy-fractionation"],"trials":["profit-trial","rtog-0415","pace-b","hypo-rt-pc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["CHHiP recruited men with localised pT1b to T3aN0M0 disease and randomised them 1:1:1 to 74 Gy in 37 fractions over 7.4 weeks, 60 Gy in 20 over 4 weeks or 57 Gy in 19 over 3.8 weeks, all with intensity-modulated technique and most with 3 to 6 months of neoadjuvant and concurrent androgen suppression. Median follow-up was 62.4 months. There were no significant differences in the proportion or cumulative incidence of side effects at 5 years on three clinician-reported and one patient-reported measure, and no treatment-related deaths (Lancet Oncology 2016).","The radiotherapy quality assurance programme, published separately, is part of why the result is trusted: 41 centres completed it, 71 percent required changes to clinical outlining before treatment, and planning errors fell from 55 percent minor and 21 percent major variations pre-trial to 49 percent minor and 6 percent major on-trial (Clinical Oncology 2019)."],"nct":"ISRCTN97182923","phase":"3","setting":"Localised prostate cancer: 60 Gy in 20 fractions or 57 Gy in 19 versus 74 Gy in 37 fractions, all with IMRT","sponsor":"Institute of Cancer Research (UK)","result":"5-year biochemical or clinical failure-free survival 90.6% (60 Gy in 20) vs 88.3% (74 Gy in 37), non-inferior.","yearReported":2016,"enrolled":3216,"enrolledBasis":"randomised","enrolledNote":"3,216 men were enrolled from 71 centres between 18 October 2002 and 17 June 2011; the trial is registered as ISRCTN97182923.","outcomes":[{"endpoint":"Biochemical or clinical failure-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"60 Gy in 20 fractions","n":1074,"value":90.6},{"name":"74 Gy in 37 fractions","n":1065,"value":88.3}]},{"endpoint":"Freedom from biochemical or clinical failure at 5 years","primary":true,"unit":"%","arms":[{"name":"60 Gy in 20 fractions","n":1074,"value":90.6,"note":"Hazard ratio and 90 percent confidence interval are 60 Gy against 74 Gy, non-inferior (pNI=0.0018); 57 Gy against 74 Gy gave 1.20 (0.99 to 1.46, pNI=0.48), non-inferiority not claimed."},{"name":"74 Gy in 37 fractions","n":1065,"value":88.3},{"name":"57 Gy in 19 fractions","n":1077,"value":85.9}],"hr":0.84,"ci":[0.68,1.03],"source":"https://doi.org/10.1016/S1470-2045(16)30102-4"},{"endpoint":"Cumulative RTOG grade 2 or worse bowel adverse events at 5 years","unit":"%","arms":[{"name":"60 Gy in 20 fractions","n":1074,"value":11.9},{"name":"74 Gy in 37 fractions","n":1065,"value":13.7},{"name":"57 Gy in 19 fractions","n":1077,"value":11.3}],"source":"https://doi.org/10.1016/S1470-2045(16)30102-4"},{"endpoint":"Cumulative RTOG grade 2 or worse bladder adverse events at 5 years","unit":"%","arms":[{"name":"60 Gy in 20 fractions","n":1074,"value":11.7},{"name":"74 Gy in 37 fractions","n":1065,"value":9.1},{"name":"57 Gy in 19 fractions","n":1077,"value":6.6}],"source":"https://doi.org/10.1016/S1470-2045(16)30102-4"}],"replication":"PROFIT (1,206 men) and RTOG 0415 (1,115 men) reached the same conclusion for moderate hypofractionation; HYPO-RT-PC and PACE-B extended it to seven and five fractions."},{"id":"nct04921527","kind":"trial","name":"Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer","aka":["CHIPRO"],"tldr":"A phase 3 trial testing Chiauranib in ovarian cancer, now recruiting.","summary":"Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer is a phase 3 interventional study registered as NCT04921527, led by Chipscreen Biosciences, and recruiting on the registry. Official title: A Multi-centre, Double-blind, Randomised Phase III Clinical Trial of Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer. Planned enrolment is 454 participants (estimated). The study started in 2021-12-20 and primary completion is expected in 2024-12-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04921527","url":"https://clinicaltrials.gov/study/NCT04921527"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["chiauranib"],"companies":["chipscreen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04921527","phase":"3","setting":"A Multi-center, Double-blind, Randomized Phase III Clinical Trial of Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer","sponsor":"Chipscreen Biosciences","started":"2021-12-20","startedType":"actual","enrolled":454,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07570849","kind":"trial","name":"Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma","aka":[],"tldr":"A phase 2 trial of gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by Shanghai Zhongshan Hospital, now recruiting.","summary":"Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma is a phase 2 interventional study registered as NCT07570849 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 35 participants, started 2026-03-01 and due to reach its primary completion in 2027-06-01. Interventions recorded: Chidamide, Gemcitabine, cisplatin, immune checkpoint inhibitor. Conditions listed: Intrahepatic Cholangiocarcinoma. Gallbladder cancer is named in the registry entry: \"3. Patients with histologically or pathologically confirmed unresectable or metastatic intrahepatic cholangiocarcinoma (ICC). Patients with extrahepatic cholangiocarcinoma (EHCC) or gallbladder cancer (GBC) are excluded.\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07570849","url":"https://clinicaltrials.gov/study/NCT07570849"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07570849","phase":"2","setting":"Open-label, Phase II Clinical Study of Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma","sponsor":"Shanghai Zhongshan Hospital","started":"2026-03-01","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06858969","kind":"trial","name":"Chidamide in Combination With PD-1 Inhibitor, Bevacizumab, and XELOX for Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, not yet recruiting.","summary":"Chidamide in Combination With PD-1 Inhibitor, Bevacizumab, and XELOX for Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT06858969 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 130 participants, started 2025-04-09 and due to reach its primary completion in 2026-01-08. Interventions recorded: Treatment group; Standard-of-care control group. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Progression-Free Survival (PFS). Colorectal eligibility wording from the registry: \"* Age ≥18 years and ≤75 years, regardless of gender; Histologically confirmed unresectable metastatic/recurrent colorectal adenocarcinoma; No prior systemic antitumor therapy received for metastatic/recurrent colorectal adenocarcinoma; For subjects who have received prior neoadjuvant/adjuvant therap\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06858969","url":"https://clinicaltrials.gov/study/NCT06858969"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06858969","phase":"2","setting":"A Phase II Clinical Study of Chidamide in Combination With PD-1 Inhibitor, Bevacizumab, and XELOX as First-Line Treatment for Metastatic Colorectal Cancer","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2025-04-09","startedType":"estimated","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05833724","kind":"trial","name":"Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)","aka":[],"tldr":"A phase 2 trial of Tucidinostat (chidamide) in peripheral T-cell lymphomas, run by Great Novel Therapeutics Biotech & Medicals Corporation, now recruiting.","summary":"Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL) is a phase 2 interventional study registered as NCT05833724 by Great Novel Therapeutics Biotech & Medicals Corporation, with 33 participants planned, started 2024-10-18 and due to reach its primary completion in 2027-06. Interventions recorded: Chidamide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05833724","url":"https://clinicaltrials.gov/study/NCT05833724"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":["epigenetic-drugs"],"targets":[],"drugs":["tucidinostat"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05833724","phase":"2","setting":"A Phase II, Open-label, Single-arm, Multicenter Study of Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma","sponsor":"Great Novel Therapeutics Biotech & Medicals Corporation","started":"2024-10-18","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"ccss","kind":"trial","name":"Childhood Cancer Survivor Study (CCSS)","aka":[],"tldr":"The largest study of what happens to children after cancer is cured. Following tens of thousands of survivors for decades, it showed that heart damage, second cancers and other late effects were common after older treatments, and that gentler modern protocols have already halved late deaths.","summary":"NCI-funded cohort coordinated at St. Jude since 1994, covering leukaemia, lymphoma, CNS tumours, Wilms tumour, neuroblastoma, soft-tissue sarcoma and bone tumours; the expansion cohort (diagnoses 1987-1999) brought the total to more than 35,000 survivors and around 5,000 siblings. Its papers quantified the late-effects burden: by age 50 most survivors have a severe or life-threatening chronic condition, driven by anthracyclines, chest radiotherapy, cranial radiotherapy and alkylators. Armstrong et al. (NEJM 2016) analysed 34,033 survivors: of 3,958 deaths, 1,618 (41%) were health-related (746 subsequent neoplasms, 241 cardiac, 137 pulmonary). Fifteen-year all-cause mortality fell from 12.4% for diagnoses in the early 1970s to 6.0% in the 1990s, and health-related mortality from 3.5% to 2.1%, attributable to reduced cranial radiotherapy in ALL, reduced abdominal radiotherapy in Wilms tumour and less anthracycline exposure. CCSS data underpin the COG Long-Term Follow-Up Guidelines, the dexrazoxane and cardiac-screening evidence, and the case for treatment de-escalation in trials such as ACNS0331 and AREN0533. Public data are available through the CCSS website, and the St. Jude Lifetime Cohort (SJLIFE) adds clinically assessed outcomes.","status":"active","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT01120353","url":"https://clinicaltrials.gov/study/NCT01120353"},{"label":"Armstrong et al., NEJM 2016","url":"https://doi.org/10.1056/NEJMoa1510795"},{"label":"CCSS","url":"https://ccss.stjude.org"},{"label":"COG Long-Term Follow-Up Guidelines","url":"http://www.survivorshipguidelines.org"}],"tags":["nci-coverage","paediatric","survivorship"],"related":["sjlife","bccss","pancaresurfup"],"cancers":["all-leukemia","hodgkin-lymphoma","medulloblastoma","wilms-tumor","neuroblastoma","rhabdomyosarcoma","osteosarcoma","ewing-sarcoma"],"sections":["rejuvenation","supportive-care"],"technologies":["survivorship-care-plan","cardio-oncology","rejuv-paed-chronic-disease-burden","rejuv-paed-late-mortality","rejuv-paed-second-cancers"],"targets":[],"drugs":[],"companies":[],"institutions":["st-jude","nci"],"pathways":[],"terms":["late-effects","cardiotoxicity"],"trials":["acns0331","aren0533"],"people":[],"bottlenecks":["b-survivorship"],"keyPapers":["paper-armstrong-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01120353","phase":"observational","setting":"Retrospective cohort with prospective follow-up of five-year survivors of childhood cancer diagnosed 1970-1999 at 31 North American centres, with sibling controls","sponsor":"St. Jude Children's Research Hospital / National Cancer Institute","result":"15-year all-cause mortality among five-year survivors fell from 12.4% (early 1970s) to 6.0% (1990s) as treatment exposures were reduced.","started":"1995-01-05","startedType":"actual","yearReported":2016,"enrolled":50000,"enrolledBasis":"registry","outcomes":[{"endpoint":"15-year cumulative all-cause mortality by treatment era","primary":true,"unit":"%","arms":[{"name":"Diagnosed early 1970s","value":12.4},{"name":"Diagnosed 1990s","value":6}],"p":"<0.001 for trend","source":"https://doi.org/10.1056/NEJMoa1510795"},{"endpoint":"15-year health-related mortality by treatment era","unit":"%","arms":[{"name":"Diagnosed early 1970s","value":3.5},{"name":"Diagnosed 1990s","value":2.1}],"p":"<0.001 for trend","source":"https://doi.org/10.1056/NEJMoa1510795"}],"replication":"The British Childhood Cancer Survivor Study, the Nordic ALiCCS cohort and the Dutch DCOG-LATER cohort report the same late-effects pattern and falling late mortality."},{"id":"nct06868654","kind":"trial","name":"China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexame","aka":[],"tldr":"A phase 3 trial of Belantamab mafodotin, Daratumumab, Bortezomib in multiple myeloma, run by GlaxoSmithKline, active and no longer recruiting.","summary":"China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT06868654 by GlaxoSmithKline, with 72 participants enrolled, started 2021-07-28 and due to reach its primary completion in 2024-04-03. Interventions recorded: Belantamab mafodotin, Daratumumab, Bortezomib, Dexamethasone. Conditions listed: Multiple Myeloma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06868654","url":"https://clinicaltrials.gov/study/NCT06868654"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["adc","antiemetic-therapy","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["belantamab-mafodotin","daratumumab","bortezomib","dexamethasone"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06868654","phase":"3","setting":"DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma","sponsor":"GlaxoSmithKline","started":"2021-07-28","startedType":"actual","yearReported":2025,"enrolled":72,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)","n":32,"note":"The median and upper limit 95% Confidence Interval were not estimable due to the length of follow-up in assessing the number of events.; Figures from the ClinicalTrials.gov results section (first posted 2025-04-23), not from a publication"},{"name":"Daratumumab + Bor + Dex","n":40,"value":8.4,"note":"95% CI 4.9 to 21.5"}],"hr":0.24,"ci":[0.11,0.56],"source":"https://clinicaltrials.gov/study/NCT06868654?tab=results"}]},{"id":"chisel","kind":"trial","name":"CHISEL (TROG 09.02)","aka":[],"tldr":"CHISEL is the randomised trial that proved stereotactic radiotherapy beats conventional radiotherapy for early lung cancer in patients who cannot have surgery, with better local control and longer survival.","summary":"CHISEL randomised 101 patients with peripheral stage I non-small-cell lung cancer unfit for surgery to stereotactic ablative radiotherapy (54 Gy in three or 48 Gy in four fractions) or conventional radiotherapy (66 Gy in 33 or 50 Gy in 20). Local failure was less frequent with stereotactic treatment (hazard ratio 0.32) and overall survival was longer, median 5 years versus 3 years, with similar toxicity (Ball and colleagues, Lancet Oncology 2019).","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01014130","url":"https://clinicaltrials.gov/study/NCT01014130"},{"label":"Lancet Oncology 2019","url":"https://doi.org/10.1016/S1470-2045(18)30896-9"}],"tags":["radiation-wave2"],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":["sbrt","respiratory-motion-management"],"targets":[],"drugs":[],"companies":["trog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-chisel-lancet-oncol-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01014130","phase":"3","setting":"Inoperable stage I non-small-cell lung cancer: stereotactic ablative radiotherapy versus conventionally fractionated radiotherapy","sponsor":"Trans-Tasman Radiation Oncology Group","result":"Local failure hazard ratio 0.32 favouring SABR; median overall survival 5 years vs 3 years.","started":"2009-12","startedType":"actual","yearReported":2019,"enrolled":101,"enrolledBasis":"registry","outcomes":[{"endpoint":"Local treatment failure (freedom from local failure was the primary endpoint)","primary":true,"unit":"%","arms":[{"name":"SABR","n":66,"value":14},{"name":"Standard radiotherapy","n":35,"value":31}],"hr":0.32,"ci":[0.13,0.77],"p":"0.0077","source":"https://doi.org/10.1016/S1470-2045(18)30896-9"}]},{"id":"chronos","kind":"trial","name":"CHRONOS","aka":[],"tldr":"The first trial to let a blood test decide whether to give an EGFR antibody a second time. A third of the patients screened had resistance mutations and were excluded; of those rechallenged, three in ten responded.","summary":"Resistance to EGFR antibodies in colorectal cancer arises through RAS, BRAF and EGFR ectodomain mutant clones that expand under treatment and then decline once the drug is withdrawn, which raises the possibility of rechallenging the same tumour later. CHRONOS was an open-label, single-arm phase 2 trial that tested this prospectively: patients whose tissue was RAS wild-type and who had already progressed on an EGFR-based regimen had an interventional circulating tumour DNA screen, and only those without a detectable RAS, BRAF or EGFR resistance mutation were rechallenged with chemotherapy-free panitumumab. Of 52 patients screened, 16 (31 percent) carried at least one resistance mutation and were excluded. Of the 27 enrolled, eight (30 percent) achieved a partial response, including two unconfirmed responses, and 17 (63 percent) had disease control. The primary endpoint was met. These figures compare favourably with standard third-line treatment, and CHRONOS is the proof that a liquid biopsy can be used interventionally, to choose treatment rather than to describe a tumour. It is small and single-arm, so anti-EGFR rechallenge remains unproven in phase 3.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03227926","url":"https://clinicaltrials.gov/study/NCT03227926"},{"label":"CHRONOS: ctDNA-guided anti-EGFR rechallenge with panitumumab in metastatic colorectal cancer (Nature Medicine 2022)","url":"https://doi.org/10.1038/s41591-022-01886-0"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["liquid-biopsy","monoclonal-antibody","mrd-testing"],"targets":["egfr","kras","nras","braf"],"drugs":["panitumumab"],"companies":[],"institutions":[],"pathways":[],"terms":["ctdna"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03227926","phase":"2","setting":"RAS wild-type metastatic colorectal cancer that had already progressed on an EGFR antibody: a blood test for RAS, BRAF and EGFR resistance mutations decides who is rechallenged with panitumumab alone","sponsor":"Fondazione del Piemonte per l'Oncologia","result":"Objective response 30 percent (8 of 27) and disease control 63 percent in ctDNA-selected patients; 31 percent of those screened were excluded by a resistance mutation.","started":"2017-10-11","startedType":"actual","yearReported":2022,"enrolled":27,"enrolledBasis":"treated","enrolledNote":"The registry lists 32 participants; 52 patients underwent the interventional circulating tumour DNA screen, 16 (31 percent) were excluded for a resistance mutation and 27 were enrolled and treated.","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"percent","arms":[{"name":"Panitumumab rechallenge after a negative ctDNA resistance screen","n":27,"value":30,"note":"8 of 27, including 2 unconfirmed"}],"source":"https://doi.org/10.1038/s41591-022-01886-0"}]},{"id":"chrysalis","kind":"trial","name":"CHRYSALIS","aka":[],"tldr":"CHRYSALIS was the first human study of amivantamab, an antibody that grabs both EGFR and MET; its cohort of people with EGFR exon 20 insertion lung cancer responded well enough to earn the drug its first approval.","summary":"CHRYSALIS is the phase 1 dose-escalation and expansion study of amivantamab, a bispecific antibody against EGFR and MET, in advanced non-small-cell lung cancer. Expansion cohorts tested the antibody alone in EGFR exon 20 insertion disease after platinum chemotherapy, and in combination with the third-generation EGFR inhibitor lazertinib or with chemotherapy in other EGFR-mutant settings.\n\nThe exon 20 insertion cohort, a group for which conventional EGFR inhibitors work poorly, showed a clinically meaningful response rate with durable responses, and amivantamab received accelerated approval in the United States in May 2021 for that indication. The combination cohorts with lazertinib provided the rationale for the phase 3 MARIPOSA and MARIPOSA-2 trials.","status":"active","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02609776","url":"https://clinicaltrials.gov/study/NCT02609776"}],"tags":["subtype-trials"],"related":[],"cancers":["egfr-mutant-nsclc","nsclc","lung-cancer"],"sections":[],"technologies":["bispecific-antibody"],"targets":[],"drugs":["amivantamab","lazertinib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["keunchil-park"],"bottlenecks":[],"keyPapers":["paper-chrysalis-nat-med-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02609776","phase":"1","setting":"Advanced non-small-cell lung cancer: first-in-human study of the bispecific EGFR and MET antibody amivantamab alone and with lazertinib or chemotherapy, with expansion cohorts by EGFR alteration","sponsor":"Janssen Research & Development","result":"Amivantamab produced durable responses in EGFR exon 20 insertion non-small-cell lung cancer after platinum chemotherapy; accelerated approval in May 2021.","started":"2016-05-24","startedType":"actual","yearReported":2021,"enrolled":751,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate, EGFR exon 20 insertion cohort after platinum chemotherapy (FDA approval summary)","unit":"%","arms":[{"name":"Amivantamab","value":40,"note":"95% CI 29 to 51"}],"source":"https://doi.org/10.1158/1078-0432.ccr-22-3713"},{"endpoint":"Duration of response, EGFR exon 20 insertion cohort","unit":"months","arms":[{"name":"Amivantamab","value":11.1,"note":"95% CI 6.9 to not evaluable"}],"source":"https://doi.org/10.1158/1078-0432.ccr-22-3713"},{"endpoint":"Infusion-related reactions","unit":"%","arms":[{"name":"Amivantamab","value":66}],"source":"https://doi.org/10.1158/1078-0432.ccr-22-3713"}]},{"id":"nct01054079","kind":"trial","name":"Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer","aka":[],"tldr":"A phase 2 trial of Cinacalcet in Prostate cancer, run by Wake Forest University Health Sciences, completed.","summary":"Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer is a phase 2 interventional study registered as NCT01054079 by Wake Forest University Health Sciences, with 20 participants recorded, started 2011-09 and reaching its primary completion in 2014-08. Interventions recorded: laboratory biomarker analysis, quality-of-life assessment, questionnaire administration, cinacalcet hydrochloride. Conditions recorded: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer.\n\nLinked to the drug Cinacalcet because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01054079","url":"https://clinicaltrials.gov/study/NCT01054079"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-bcr"],"sections":[],"technologies":[],"targets":[],"drugs":["cinacalcet"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01054079","phase":"2","setting":"A Phase II Trial to Assess the Effect of Cinacalcet Hydrochloride on PSA Levels in Patients With Biochemically Recurrent Prostate Cancer After Failed Definitive Local Therapy","sponsor":"Wake Forest University Health Sciences","started":"2011-09","yearReported":2015,"enrolled":20,"enrolledBasis":"registry","outcomes":[{"endpoint":"Rate of Rise of Serum PSA","primary":true,"unit":"nanograms per milliliter","arms":[{"name":"Treatment (Cinacalcet Hydrochloride)","n":10,"value":0.0825,"note":"IQR -0.01 to 0.17; Figures from the ClinicalTrials.gov results section (first posted 2015-10-29), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01054079?tab=results"}]},{"id":"nct05190445","kind":"trial","name":"Cinrebafusp Alfa in Combination With Ramucirumab and Paclitaxel in HER2-High Gastric or GEJ Adenocarcinoma and in Combination With Tucatinib in HER2-Low Gastric or GEJ Andenocarinoma","aka":[],"tldr":"A phase 2 trial of Cinrebafusp alfa, Ramucirumab and Tucatinib in gastric & gastro-oesophageal junction cancer, run by Pieris Pharmaceuticals, Inc., active and no longer recruiting.","summary":"Cinrebafusp Alfa in Combination With Ramucirumab and Paclitaxel in HER2-High Gastric or GEJ Adenocarcinoma and in Combination With Tucatinib in HER2-Low Gastric or GEJ Andenocarinoma is a phase 2 interventional study registered as NCT05190445 by Pieris Pharmaceuticals, Inc., with 80 participants enrolled, started 2021-11-01 and due to reach its primary completion in 2023-02-01. Interventions recorded: Cinrebafusp alfa (PRS-343) in combination with ramucirumab and paclitaxel and Cinrebafusp alfa (PRS-343) in combination with tucatinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05190445","url":"https://clinicaltrials.gov/study/NCT05190445"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["antiangiogenic","her2-tyrosine-kinase-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["cinrebafusp-alfa","ramucirumab","tucatinib"],"companies":["pieris-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05190445","phase":"2","setting":"A Phase 2, Multi-Center, Open-Label Study of Cinrebafusp Alfa (PRS-343) in Combination With Ramucirumab and Paclitaxel in Patients With HER2-Positive Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination With Tucatinib in Patients With HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma","sponsor":"Pieris Pharmaceuticals, Inc.","started":"2021-11-01","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"circulate-japan","kind":"trial","name":"CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)","aka":["GALAXY","VEGA","ALTAIR"],"tldr":"Japan's national programme tests whether a blood test after surgery should decide who gets chemotherapy, and whether treating a positive test early helps.","summary":"GALAXY (observational, >2,000 patients) showed ctDNA positivity 4 weeks post-surgery is the strongest predictor of recurrence (Nature Medicine 2023). ALTAIR (ctDNA-positive, randomised to trifluridine/tipiracil vs placebo) missed its DFS endpoint (2024), suggesting late-line chemotherapy does not clear MRD. VEGA (ctDNA-negative, omit vs give CAPOX) is ongoing. Together with DYNAMIC these define the state of ctDNA-guided adjuvant therapy in CRC.","status":"active","asOf":"2026-09-07","links":[{"label":"GALAXY, Nature Medicine 2023","url":"https://www.nature.com/articles/s41591-022-02115-4"},{"label":"ALTAIR: post-adjuvant chemotherapy in ctDNA-positive patients with resected colorectal cancer (Nature Medicine 2026)","url":"https://doi.org/10.1038/s41591-026-04428-0"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["mrd-testing","liquid-biopsy"],"targets":[],"drugs":["signatera","trifluridine-tipiracil","capox"],"companies":[],"institutions":["ncc-japan"],"pathways":[],"terms":["mrd","ctdna"],"trials":["dynamic","altair","dynamic-iii"],"people":["jeanne-tie","yoshino-takayuki"],"bottlenecks":[],"keyPapers":["paper-henriksen-ctdna-stage-iii-colorectal-improve-it-ccr-2022","paper-nakamura-triumph-ctdna-pertuzumab-trastuzumab-her2-colorectal-nat-med-2021"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Resected stage II-IV colorectal cancer: ctDNA (Signatera) to guide adjuvant chemotherapy de-escalation (VEGA) or escalation with trifluridine/tipiracil (ALTAIR)","sponsor":"National Cancer Center Japan","result":"GALAXY: ctDNA+ post-op HR for recurrence ~10; ALTAIR: DFS endpoint not met.","yearReported":2023,"enrolledBasis":"registry","outcomes":[{"endpoint":"GALAXY (observational): recurrence risk by post-operative ctDNA status (4 weeks after surgery)","arms":[{"name":"ctDNA-positive","note":"n = 1,039 resectable stage II-IV CRC; ctDNA positivity was the strongest prognostic factor and identified who benefited from adjuvant chemotherapy (HR 6.59)"},{"name":"ctDNA-negative"}],"hr":10,"p":"<0.0001","source":"https://doi.org/10.1038/s41591-022-02115-4"},{"endpoint":"ALTAIR (randomised phase 3): disease-free survival in post-adjuvant ctDNA-positive patients","primary":true,"unit":"months","arms":[{"name":"Trifluridine/tipiracil","n":122,"value":9.3,"note":"Primary endpoint not met"},{"name":"Placebo","n":121,"value":5.55}],"hr":0.79,"ci":[0.6,1.05],"p":"0.107","source":"https://doi.org/10.1038/s41591-026-04428-0"}],"replication":"GALAXY's prognostic ctDNA signal matches DYNAMIC, CIRCULATE-PRODIGE and BESPOKE cohorts; the interventional ALTAIR arm shows that detecting molecular recurrence does not yet translate into a DFS gain with trifluridine/tipiracil. VEGA (de-escalation) still pending."},{"id":"circulate-us","kind":"trial","name":"CIRCULATE-US","aka":["NRG-GI008","Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease"],"tldr":"The US national trial that uses a blood test for leftover tumour DNA to decide who gets less chemotherapy and who gets more after stage III colon cancer surgery, with both questions randomised.","summary":"CIRCULATE-US (NRG-GI008) is the NRG Oncology phase 2/3 trial in resected stage III colon cancer. Patients are tested with Signatera after surgery; ctDNA-negative patients are randomised between immediate chemotherapy and surveillance with treatment on conversion, and ctDNA-positive patients are randomised between standard mFOLFOX6 or CAPOX and intensified mFOLFIRINOX. The registry lists an estimated 1,912 participants, a start on 8 July 2022, recruiting status, primary completion on 10 March 2029 and study completion on 10 March 2030. It is the US counterpart of CIRCULATE-Japan and TRACC and the trial most likely to settle whether escalation helps ctDNA-positive colon cancer.","status":"recruiting","asOf":"2026-09-21","links":[{"label":"ClinicalTrials.gov NCT05174169","url":"https://clinicaltrials.gov/study/NCT05174169"}],"tags":["ctdna-roadmap"],"related":["dynamic","circulate-japan","tracc","ctdna-mrd-to-adjuvant","ctdna-tests"],"cancers":["colorectal"],"sections":[],"technologies":["mrd-testing","liquid-biopsy"],"targets":[],"drugs":["signatera","capox"],"companies":["nrg-oncology","natera"],"institutions":[],"pathways":[],"terms":["mrd","ctdna","de-escalation","tumour-informed-assay"],"trials":["dynamic-iii","altair"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05174169","phase":"2/3","setting":"Resected stage III colon cancer in the United States: Signatera result assigns patients to randomised de-escalation (shorter or later chemotherapy) if negative or escalation (mFOLFIRINOX against mFOLFOX6 or CAPOX) if positive","sponsor":"NRG Oncology","started":"2022-07-08","startedType":"actual","enrolled":1912,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04120701","kind":"trial","name":"CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II","aka":["CIRCULATE"],"tldr":"A phase 3 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Centre Hospitalier Universitaire Dijon, now recruiting.","summary":"CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II is a phase 3, randomised interventional study registered as NCT04120701 by Centre Hospitalier Universitaire Dijon, with a registry enrolment figure of 1980 participants, started 2020-01-17 and due to reach its primary completion in 2032-03. Interventions recorded: mFOLFOX6. Conditions listed: Patients With Resected Stage II Colon Cancer. Primary outcome: 3-year Disease-Free Survival in ctDNA positive patients. Colorectal eligibility wording from the registry: \"* Histologically confirmed stage II colon and high rectum adenocarcinoma excluding low and medium rectal cancers (tumor location ≥ 12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery are still eligible), without gross or microscopic evidence of residual disease a\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04120701","url":"https://clinicaltrials.gov/study/NCT04120701"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","mrd-testing","platinum"],"targets":[],"drugs":["folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04120701","phase":"3","setting":"CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II","sponsor":"Centre Hospitalier Universitaire Dijon","started":"2020-01-17","startedType":"actual","enrolled":1980,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06992336","kind":"trial","name":"Circulating Tumor DNA Guided Boost Therapy in Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy","aka":[],"tldr":"A phase 2 trial of anlotinib, benmelstobart and capecitabine in triple-negative breast cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, now recruiting.","summary":"Circulating Tumor DNA Guided Boost Therapy in Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy is a phase 2, randomised interventional study registered as NCT06992336 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, with a registry enrolment figure of 411 participants, started 2025-04-10 and due to reach its primary completion in 2031-04-10. Interventions recorded: Anlotinib ,; Benmelstobart; Capecitabine. Conditions listed: Breast Cancer. Triple-negative eligibility wording from the registry: \"* TNBC patients\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06992336","url":"https://clinicaltrials.gov/study/NCT06992336"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["anlotinib","benmelstobart","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06992336","phase":"2","setting":"A Phase II, Open-label, Randomized Trial to Compare Anlotinib and Immunotherapy and Capecitabine Versus Investigator's Choice Therapy in High Risk ctDNA Positive, Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","started":"2025-04-10","startedType":"actual","enrolled":411,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05954078","kind":"trial","name":"Circulating Tumor DNA Methylation Guided Postoperative Adjuvant Chemotherapy for High-risk Stage II/III Colorectal Cancer","aka":["FINE"],"tldr":"A phase 3 trial in colorectal cancer, run by Fudan University, now recruiting.","summary":"Circulating Tumor DNA Methylation Guided Postoperative Adjuvant Chemotherapy for High-risk Stage II/III Colorectal Cancer is a phase 3, randomised interventional study registered as NCT05954078 by Fudan University, with a registry enrolment figure of 340 participants, started 2023-08-01 and due to reach its primary completion in 2026-06. Interventions recorded: mFOLFIRINOX adjuvant chemotherapy; mFOLFOX6/XELOX adjuvant chemotherapy. Conditions listed: High-risk Stage II Colorectal Cancer; Stage III Colorectal Cancer; Circulating Tumor DNA Methylation. Primary outcome: ctDNA clearance rate. Colorectal eligibility wording from the registry: \"Patients who have been histopathologically diagnosed with colorectal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05954078","url":"https://clinicaltrials.gov/study/NCT05954078"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05954078","phase":"3","setting":"Circulating Tumor DNA Methylation Guided Postoperative Adjuvant Chemotherapy for High-risk Stage II/III Colorectal Cancer: A Multicenter, Prospective, Randomized Controlled Cohort Study (FINE Trial)","sponsor":"Fudan University","started":"2023-08-01","startedType":"actual","enrolled":340,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04068103","kind":"trial","name":"Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery","aka":["COBRA"],"tldr":"A phase 2/3 trial of capecitabine, fluorouracil (5-FU), fOLFOX (5-FU, leucovorin, oxaliplatin) and leucovorin (folinic acid) in colorectal cancer, run by NRG Oncology, active but no longer recruiting.","summary":"Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery is a phase 2/3, randomised interventional study registered as NCT04068103 by NRG Oncology, with a registry enrolment figure of 635 participants, started 2019-12-16 and due to reach its primary completion in 2023-06-30. Interventions recorded: Capecitabine; Fluorouracil; Leucovorin; Leucovorin Calcium; Oxaliplatin; Patient Observation. Conditions listed: Colon Adenocarcinoma; Stage IIA Colon Cancer AJCC v8. Primary outcome: Clearance of Circulating Tumor Deoxyribonucleic Acid (ctDNA) (to Undetectable Levels) for the \"Baseline ctDNA Detected\" Patient Subset (Phase II); Recurrence-free Survival (RFS) the \"Baseline ctDNA Detected\" Patient Subset (Phase III). Colorectal eligibility wording from the registry: \"* Histologically/pathologically confirmed stage IIA adenocarcinoma of the colon (T3, N0, M0) with at least 12 lymph nodes examined at the time of surgical resection\". Sites: Canada, Puerto Rico, United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04068103","url":"https://clinicaltrials.gov/study/NCT04068103"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","mrd-testing","platinum"],"targets":[],"drugs":["capecitabine","fluorouracil","folfox","leucovorin"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04068103","phase":"2/3","setting":"Phase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Patients With Stage IIA Colon Cancer (COBRA)","sponsor":"NRG Oncology","started":"2019-12-16","startedType":"actual","enrolled":635,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05770531","kind":"trial","name":"Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy","aka":[],"tldr":"A phase 2 trial of sacituzumab govitecan in triple-negative breast cancer, run by Vanderbilt-Ingram Cancer Center, now recruiting.","summary":"Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy is a phase 2, randomised interventional study registered as NCT05770531 by Vanderbilt-Ingram Cancer Center, with a registry enrolment figure of 160 participants, started 2023-10-03 and due to reach its primary completion in 2028-08-01. Interventions recorded: Biospecimen Collection; Computed Tomography; Magnetic Resonance Imaging; Biospecimen Collection; Sacituzumab Govitecan. Conditions listed: Metastatic HER2-Negative Breast Carcinoma; Metastatic Triple-Negative Breast Carcinoma. Triple-negative eligibility wording from the registry: \"* Malignancies other than TNBC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05770531","url":"https://clinicaltrials.gov/study/NCT05770531"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05770531","phase":"2","setting":"A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer","sponsor":"Vanderbilt-Ingram Cancer Center","started":"2023-10-03","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05601505","kind":"trial","name":"Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer","aka":["CINTS-R"],"tldr":"A phase 2 trial in colorectal cancer, run by Peking Union Medical College Hospital, now recruiting.","summary":"Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT05601505 by Peking Union Medical College Hospital, with a registry enrolment figure of 470 participants, started 2023-02-03 and due to reach its primary completion in 2025-10-31. Interventions recorded: circulating tumor DNA. Conditions listed: Locally Advanced Rectal Carcinoma; Circulating Tumor DNA. Primary outcome: two-year disease-related treatment failure, 2y-DrTF. Colorectal eligibility wording from the registry: \"Rectal adenocarcinoma confirmed by pathology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05601505","url":"https://clinicaltrials.gov/study/NCT05601505"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05601505","phase":"2","setting":"Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer --- a Multicenter Randomized Controlled Trial (CINTS-R)","sponsor":"Peking Union Medical College Hospital","started":"2023-02-03","startedType":"actual","enrolled":470,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06896890","kind":"trial","name":"Cisplatin (CIS) Administered As Dry Powder for Inhalation (DPI) in Patients with Stage IV Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of CIS-DPI in non-small-cell lung cancer, run by Inhatarget Therapeutics, now recruiting.","summary":"Cisplatin (CIS) Administered As Dry Powder for Inhalation (DPI) in Patients with Stage IV Non-Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT06896890 by Inhatarget Therapeutics, with 32 participants planned, started 2023-06-23 and due to reach its primary completion in 2026-10-01. Interventions recorded: CIS-DPI.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06896890","url":"https://clinicaltrials.gov/study/NCT06896890"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06896890","phase":"1/2","setting":"A Phase I/II First-in-human Trial Investigating Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Ascending Doses of a Dry Powder Cisplatin Formulation for Inhalation to Treat Stage IV Non-small Cell Lung Cancer Patients","sponsor":"Inhatarget Therapeutics","started":"2023-06-23","startedType":"actual","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06037980","kind":"trial","name":"CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence","aka":["PURITY"],"tldr":"A phase 2/3 trial of gemcitabine, cisplatin, capecitabine and paclitaxel in gallbladder cancer and other biliary tract cancers, run by Gruppo Oncologico del Nord-Ovest, now recruiting.","summary":"CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence is a phase 2/3, randomised interventional study registered as NCT06037980 by Gruppo Oncologico del Nord-Ovest, with a registry enrolment figure of 300 participants, started 2023-11-07 and due to reach its primary completion in 2028-12. Interventions recorded: Gemcitabine, Nab paclitaxel, Cisplatin, Curative Surgery, Capecitabine. Conditions listed: Biliary Tract Cancer, Cholangiocarcinoma. Gallbladder cancer is named in the registry entry: \"3. Histologically or cytologically confirmed non metastatic resectable carcinoma of biliary tract (BTC), including gallbladder carcinoma (GBC), intrahepatic, periperihilar or distal Cholangiocarcinoma (CCA). Mixed tumor \". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06037980","url":"https://clinicaltrials.gov/study/NCT06037980"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine","cisplatin","capecitabine","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":["hepatectomy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06037980","phase":"2/3","setting":"A Phase II/III Randomized Clinical Trial of CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence: PURITY Study","sponsor":"Gruppo Oncologico del Nord-Ovest","started":"2023-11-07","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06095141","kind":"trial","name":"Cisplatin to Patients With Pancreatic Cancer and Homologous Recombination Deficiency","aka":["PTCA199-6"],"tldr":"A phase 2/3 trial of cisplatin in pancreatic cancer, run by Fudan University, now recruiting.","summary":"Cisplatin to Patients With Pancreatic Cancer and Homologous Recombination Deficiency is a phase 2/3, interventional study registered as NCT06095141 by Fudan University, with a registry enrolment figure of 30 participants, started 2023-12-01 and due to reach its primary completion in 2025-10-31. Interventions recorded: Cisplatin. Conditions listed: Pancreatic Adenocarcinoma; Homologous Recombination Deficiency. Primary outcome: progression-free survival, PFS. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed advanced pancreas adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06095141","url":"https://clinicaltrials.gov/study/NCT06095141"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac","brca-palb2-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06095141","phase":"2/3","setting":"Cisplatin Based Regimen to Patients With Advanced Pancreatic Cancer and Homologous Recombination Deficiency","sponsor":"Fudan University","started":"2023-12-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00652132","kind":"trial","name":"Cisplatin With or Without Sodium Thiosulfate in Treating Young Patients With Stage I, II, or III Childhood Liver Cancer","aka":["SIOPEL6"],"tldr":"A phase 3 trial of Cisplatin and Sodium thiosulfate in Hepatocellular carcinoma, run by University of Birmingham, completed.","summary":"Cisplatin With or Without Sodium Thiosulfate in Treating Young Patients With Stage I, II, or III Childhood Liver Cancer is a phase 3 interventional study registered as NCT00652132 by University of Birmingham, with 116 participants recorded, started 2007-12-15 and reaching its primary completion in 2017-09-04. Interventions recorded: cisplatin, sodium thiosulfate. Conditions recorded: Liver Cancer, Ototoxicity.\n\nLinked to the drug Sodium thiosulfate because the registry names it among its interventions and Hepatocellular carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00652132","url":"https://clinicaltrials.gov/study/NCT00652132"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":[],"targets":[],"drugs":["cisplatin","sodium-thiosulfate"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00652132","phase":"3","setting":"A Multi-centre Open-label Randomised Phase III Trial of the Efficacy of Sodium Thiosulphate in Reducing Ototoxicity in Patients Receiving Cisplatin Chemotherapy for Standard Risk Hepatoblastoma","sponsor":"University of Birmingham","started":"2007-12-15","startedType":"actual","enrolled":116,"enrolledBasis":"registry","outcomes":[]},{"id":"ck-301-101","kind":"trial","name":"CK-301-101","aka":["Study CK-301-101","Cosibelimab pivotal study"],"tldr":"CK-301-101 was the first study of cosibelimab, and its skin squamous cell cancer groups, where about half of tumours shrank, led to the drug's US approval in December 2024.","summary":"CK-301-101 was an open-label, multicentre, first-in-human phase 1 study of the PD-L1 antibody cosibelimab given alone to adults with advanced cancers, with a dose-escalation part followed by expansion cohorts in several tumour types (272 patients in all on the registry, which lists the study as active and no longer recruiting). Its pivotal cohorts enrolled 109 patients with cutaneous squamous cell carcinoma not suitable for curative surgery or radiotherapy, 78 with metastatic and 31 with locally advanced disease. The primary efficacy endpoint was objective response rate by independent central review using RECIST 1.1, with digital photography under WHO criteria for externally visible lesions; there was no control arm.\n\nIn the metastatic cohort, treated with 800 mg every 2 weeks, 37 of 78 patients responded (47.4 percent, 95% CI 36.0 to 59.1) at a median follow-up of 15.4 months; the median duration of response was not reached and 73 percent of responders were still responding at data cut-off. Immune-related adverse events occurred in 23 percent, grade 3 in 2.6 percent, with no grade 4 or 5 events and no treatment-related deaths (Journal for ImmunoTherapy of Cancer 2023). The current US label reports the same cohorts at a later cut: 39 of 78 (50 percent) in metastatic and 17 of 31 (55 percent) in locally advanced disease, with median duration of response not reached in either. A longer follow-up report (median 29.3 months metastatic, 24.1 months locally advanced) gave 50.0 and 54.8 percent (Journal of the American Academy of Dermatology 2026).\n\nCosibelimab was approved in the US in December 2024, the third PD-1 pathway antibody for this cancer after cemiplimab (EMPOWER-CSCC-1) and pembrolizumab (KEYNOTE-629).","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03212404","url":"https://clinicaltrials.gov/study/NCT03212404"},{"label":"Journal for ImmunoTherapy of Cancer 2023 (metastatic cohort)","url":"https://doi.org/10.1136/jitc-2023-007637"},{"label":"Unloxcyt label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=06bdadd5-d2db-406f-a3f8-de47f48a52e3"},{"label":"Journal of the American Academy of Dermatology 2026 (longer follow-up)","url":"https://doi.org/10.1016/j.jaad.2025.09.009"}],"tags":[],"related":["empower-cscc-1","keynote-629"],"cancers":["cutaneous-scc","advanced-cutaneous-scc","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1"],"drugs":["cosibelimab"],"companies":["checkpoint-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["empower-cscc-1","keynote-629","c-post"],"people":[],"bottlenecks":[],"keyPapers":["paper-ck-301-101-jitc-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03212404","phase":"1","setting":"Metastatic or locally advanced cutaneous squamous cell carcinoma not suitable for curative surgery or radiotherapy: cosibelimab expansion cohorts within a first-in-human phase 1 study in advanced cancers","sponsor":"Checkpoint Therapeutics","result":"Objective response 47% (37 of 78) in metastatic disease by independent central review at the primary report, median duration of response not reached; the current label reports 50% (39 of 78) metastatic and 55% (17 of 31) locally advanced.","started":"2017-09-20","startedType":"actual","yearReported":2023,"enrolled":272,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate, independent central review (metastatic cohort)","primary":true,"unit":"%","arms":[{"name":"Cosibelimab","n":78,"value":47.4,"note":"37 of 78 (95% CI 36.0 to 59.1); 800 mg every 2 weeks; median follow-up 15.4 months"}],"source":"https://doi.org/10.1136/jitc-2023-007637"},{"endpoint":"Objective response rate, independent central review (locally advanced cohort, US label)","unit":"%","arms":[{"name":"Cosibelimab","n":31,"value":55,"note":"17 of 31 (95% CI 36 to 73) in the September 2026 label, which also reports 39 of 78 (50%) metastatic at the same cut"}],"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=06bdadd5-d2db-406f-a3f8-de47f48a52e3"}],"replication":"Response rates of the same order as EMPOWER-CSCC-1 (cemiplimab) and KEYNOTE-629 (pembrolizumab); no trial has compared cosibelimab with a PD-1 antibody directly."},{"id":"claridhy","kind":"trial","name":"ClarIDHy","aka":[],"tldr":"The first randomised trial of a targeted drug in bile duct cancer; it slowed the disease without shrinking it.","summary":"ClarIDHy, trial NCT02989857 sponsored by Agios, now Servier, and reported in 2020, was the first randomised trial of a targeted drug in bile duct cancer, testing ivosidenib against placebo in previously treated IDH1-mutant cholangiocarcinoma. It randomised 187 patients, met its primary progression-free survival endpoint with a large relative effect, and showed an overall survival benefit once adjusted for crossover, but the response rate was only about two percent, so it slowed the disease without shrinking it. OnCo links it to biliary tract cancer, IDH1 and IDH2 as targets, ivosidenib and Ghassan K. Abou-Alfa. Whether a drug that stabilises rather than shrinks tumours is worth its cost in a setting with few alternatives is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02989857","url":"https://clinicaltrials.gov/study/NCT02989857"},{"label":"Tibsovo label (openFDA): ClarIDHy baseline characteristics","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22TIBSOVO%22"}],"tags":[],"related":[],"cancers":["cholangiocarcinoma","intrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["epigenetic-drugs","idh-inhibitors","kinase-inhibitors"],"targets":["idh"],"drugs":["ivosidenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ghassan-abou-alfa"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Gallbladder cancer: 91 percent of ClarIDHy patients had intrahepatic cholangiocarcinoma and 92 percent had metastatic disease (Tibsovo label); IDH1 mutation is an intrahepatic feature and the trial gives no gallbladder evidence."],"nct":"NCT02989857","phase":"3","setting":"Previously treated IDH1-mutant cholangiocarcinoma: ivosidenib vs placebo","sponsor":"Agios (now Servier)","result":"PFS HR 0.37; crossover-adjusted OS HR 0.49.","started":"2017-02-20","startedType":"actual","yearReported":2020,"enrolled":187,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Ivosidenib","n":126,"value":2.7},{"name":"Placebo","n":61,"value":1.4}],"hr":0.37,"ci":[0.25,0.54],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(20)30157-1"},{"endpoint":"Overall survival (crossover-adjusted)","unit":"months","arms":[{"name":"Ivosidenib","value":10.3},{"name":"Placebo","value":7.5}],"hr":0.49,"source":"https://doi.org/10.1016/S1470-2045(20)30157-1"}]},{"id":"clarinet","kind":"trial","name":"CLARINET","aka":[],"tldr":"Lanreotide more than halved the risk of progression in gut and pancreatic neuroendocrine tumours.","summary":"CLARINET, trial NCT00353496 sponsored by Ipsen and reported in 2014, showed that lanreotide more than halved the risk of progression in non-functioning grade 1 to 2 gastroenteropancreatic neuroendocrine tumours. It randomised 204 patients to lanreotide 120 mg or placebo and met its primary progression-free survival endpoint, with the median not reached in the lanreotide arm, and it is the basis of lanreotide's antiproliferative label. OnCo links it to neuroendocrine tumours, the somatostatin analogues record, Ipsen and Martyn E. Caplin. Whether patients with stable disease need treatment at diagnosis or can safely wait for progression is the question the trial's design, which enrolled many stable patients, leaves open.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00353496","url":"https://clinicaltrials.gov/study/NCT00353496"}],"tags":[],"related":[],"cancers":["neuroendocrine","small-intestinal-net","pancreatic-net"],"sections":[],"technologies":[],"targets":[],"drugs":["octreotide-lanreotide"],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["martyn-caplin"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00353496","phase":"3","setting":"Non-functioning enteropancreatic NETs, grade 1-2: lanreotide 120 mg vs placebo","sponsor":"Ipsen","result":"PFS HR 0.47.","started":"2006-06","yearReported":2014,"enrolled":204,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Lanreotide","n":101,"note":"not reached"},{"name":"Placebo","n":103,"value":18}],"hr":0.47,"ci":[0.3,0.73],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1316158"}]},{"id":"clarity-gastric01","kind":"trial","name":"CLARITY-Gastric 01","aka":[],"tldr":"The first ADC against Claudin 18.2 to prove it extends life, announced July 2026, giving stomach cancer its first ADC beyond HER2.","summary":"CLARITY-Gastric 01, trial NCT06346392 sponsored by AstraZeneca and announced in July 2026, is the first phase 3 to prove that an antibody-drug conjugate against Claudin 18.2 extends life, giving stomach cancer its first ADC beyond HER2. It randomised 594 patients with second- or later-line CLDN18.2-positive advanced gastric or gastro-oesophageal junction cancer to sonesitatug vedotin, also known as AZD0901 or CMG901, or investigator's choice chemotherapy, and met its co-primary overall survival endpoint in third-line or later disease, with survival in the whole population also significant and progression-free survival trending favourably; full data await presentation. OnCo links it to gastric and oesophageal cancer, Claudin 18.2 as a target, sonesitatug vedotin and ramucirumab. Whether the drug works after zolbetuximab is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06346392","url":"https://clinicaltrials.gov/study/NCT06346392"},{"label":"ASCO GI 2025 trial-in-progress","url":"https://ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.TPS507"}],"tags":[],"related":[],"cancers":["gastric"],"sections":[],"technologies":["adc"],"targets":["cldn18-2"],"drugs":["cmg901","ramucirumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06346392","phase":"3","setting":"Second- or later-line CLDN18.2-positive advanced gastric/GEJ cancer: sonesitatug vedotin (AZD0901/CMG901) vs investigator's choice","sponsor":"AstraZeneca","result":"Co-primary endpoints including OS met (July 2026); numbers pending.","started":"2024-03-04","startedType":"actual","yearReported":2026,"enrolled":594,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, third-line or later (dual primary)","primary":true,"unit":"months","arms":[{"name":"Sonesitatug vedotin 2.2 mg/kg","note":"Met with a statistically significant, clinically meaningful improvement per the sponsor (27 July 2026); OS in the whole second-line-or-later population (key secondary) also significant. Medians and hazard ratios pending presentation."},{"name":"Investigator's choice chemotherapy"}],"source":"https://www.cancernetwork.com/view/sonesitatug-vedotin-improves-overall-survival-in-cldn18-2-gastric-cancer"},{"endpoint":"Progression-free survival (BICR), second-line or later (dual primary)","primary":true,"unit":"months","arms":[{"name":"Sonesitatug vedotin 2.2 mg/kg","note":"Trend favouring sonesitatug vedotin; did not reach statistical significance"},{"name":"Investigator's choice chemotherapy"}],"source":"https://www.cancernetwork.com/view/sonesitatug-vedotin-improves-overall-survival-in-cldn18-2-gastric-cancer"}],"replication":"First phase 3 OS win for a CLDN18.2 ADC; builds on the phase 1 KYM901 signal and on zolbetuximab (SPOTLIGHT/GLOW) validating the target in first line. Numbers awaited."},{"id":"classic","kind":"trial","name":"CLASSIC","aka":["CLASSIC trial","L_9570"],"tldr":"CLASSIC showed that six months of capecitabine and oxaliplatin after a thorough stomach cancer operation stops the cancer returning in many more people, with 68 percent free of disease at five years against 53 percent with surgery alone, and more of them alive; it made CAPOX one of the two standard adjuvant treatments in East Asia.","summary":"CLASSIC was an open-label phase 3 trial at 37 centres in South Korea, China and Taiwan that randomised 1,035 patients with stage II to IIIB gastric cancer after curative D2 gastrectomy to eight three-week cycles of capecitabine and oxaliplatin (520) or observation (515). The primary endpoint was three-year disease-free survival.\n\nThree-year disease-free survival was 74 percent with chemotherapy against 59 percent with surgery alone (hazard ratio 0.56), and at five years 68 against 53 percent with overall survival of 78 against 69 percent (hazard ratio 0.66). Grade 3 or 4 adverse events occurred in 56 percent of treated patients, mainly nausea, neutropenia and loss of appetite. With ACTS-GC (adjuvant S-1 in Japan) the trial defines adjuvant chemotherapy after D2 gastrectomy in East Asia, which is how the corpus's gastric cancer page cites it.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00411229","url":"https://clinicaltrials.gov/study/NCT00411229"}],"tags":["soc-trials"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine","oxaliplatin"],"companies":["sanofi","roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-classic-adjuvant-capox-gastric-bang-lancet-2012","paper-classic-5-year-follow-up-noh-lancet-oncol-2014"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00411229","phase":"3","setting":"Stage II to IIIB gastric adenocarcinoma after curative D2 gastrectomy in South Korea, China and Taiwan: eight cycles of adjuvant capecitabine and oxaliplatin (CAPOX) against surgery alone, with disease-free survival as the primary endpoint","sponsor":"Sanofi","result":"Three-year disease-free survival 74 percent with adjuvant CAPOX against 59 percent with surgery alone (hazard ratio 0.56, p < 0.0001); five-year overall survival 78 against 69 percent (hazard ratio 0.66).","started":"2006-06","yearReported":2012,"enrolled":1035,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Adjuvant capecitabine + oxaliplatin","n":520,"value":74,"note":"95% CI 69 to 79"},{"name":"Surgery alone (observation)","n":515,"value":59,"note":"95% CI 53 to 64"}],"hr":0.56,"ci":[0.44,0.72],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(11)61873-4"},{"endpoint":"Disease-free survival at 5 years","unit":"%","arms":[{"name":"Adjuvant capecitabine + oxaliplatin","n":520,"value":68,"note":"95% CI 63 to 73"},{"name":"Surgery alone (observation)","n":515,"value":53,"note":"95% CI 47 to 58"}],"hr":0.58,"ci":[0.47,0.72],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(14)70473-5"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Adjuvant capecitabine + oxaliplatin","n":520,"value":78,"note":"95% CI 74 to 82"},{"name":"Surgery alone (observation)","n":515,"value":69,"note":"95% CI 64 to 73"}],"hr":0.66,"ci":[0.51,0.85],"p":"0.0015","source":"https://doi.org/10.1016/S1470-2045(14)70473-5"},{"endpoint":"Grade 3 or 4 adverse events","unit":"%","arms":[{"name":"Adjuvant capecitabine + oxaliplatin","n":496,"value":56},{"name":"Surgery alone (observation)","n":478,"value":6}],"source":"https://doi.org/10.1016/S0140-6736(11)61873-4"}]},{"id":"nct04404595","kind":"trial","name":"Claudin18.2 CAR-T (CT041) in Patients With Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers","aka":[],"tldr":"A phase 1/2 trial of CT041 in gastric & gastro-oesophageal junction cancer and pancreatic ductal adenocarcinoma, run by CARsgen Therapeutics Co., Ltd., active and no longer recruiting.","summary":"Claudin18.2 CAR-T (CT041) in Patients With Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers is a phase 1/2 interventional study registered as NCT04404595 by CARsgen Therapeutics Co., Ltd., with 110 participants enrolled, started 2020-10-23 and due to reach its primary completion in 2025-06-01. Interventions recorded: CT041.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04404595","url":"https://clinicaltrials.gov/study/NCT04404595"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","pancreatic","metastatic-pdac","gastric-cldn18-2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["carsgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04404595","phase":"1/2","setting":"Open-label, Multicenter, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous Anti-claudin 18.2 Chimeric Antigen Receptor T-cell Therapy in Subjects With Advanced Gastric, Pancreatic, or Other Specified Digestive System Cancers","sponsor":"CARsgen Therapeutics Co., Ltd.","started":"2020-10-23","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"clear","kind":"trial","name":"CLEAR (KEYNOTE-581)","aka":[],"tldr":"The combination with the longest progression-free survival ever reported in first-line kidney cancer, at nearly two years.","summary":"CLEAR, also KEYNOTE-581, trial NCT02811861 sponsored by Eisai and Merck and reported in 2021, produced the combination with the longest progression-free survival ever reported in first-line kidney cancer, at nearly two years. It randomised 1,069 patients with untreated advanced clear-cell renal cell carcinoma to lenvatinib plus pembrolizumab, lenvatinib plus everolimus or sunitinib, met its primary progression-free survival endpoint with a very large effect and a high response rate including many complete responses, and showed a survival benefit whose curves separated late, leading to FDA approval in August 2021, although the 20 mg lenvatinib dose drives high toxicity with dose reductions in about seventy percent. Whether a lower lenvatinib starting dose would keep the efficacy is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02811861","url":"https://clinicaltrials.gov/study/NCT02811861"}],"tags":[],"related":[],"cancers":["rcc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["lenvatinib","pembrolizumab","sunitinib","everolimus"],"companies":["eisai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["robert-motzer"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02811861","phase":"3","setting":"Untreated advanced clear-cell RCC: lenvatinib + pembrolizumab vs sunitinib (and lenvatinib + everolimus arm)","sponsor":"Eisai / Merck","result":"PFS 23.9 vs 9.2 months (HR 0.39); OS HR 0.79.","started":"2016-10-13","startedType":"actual","yearReported":2021,"enrolled":1069,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Lenvatinib + pembrolizumab","n":355,"value":23.9},{"name":"Sunitinib","n":357,"value":9.2}],"hr":0.39,"ci":[0.32,0.49],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2035716"},{"endpoint":"Overall survival (final)","unit":"months","arms":[{"name":"Lenvatinib + pembrolizumab","value":53.7},{"name":"Sunitinib","value":54.3}],"hr":0.79,"ci":[0.63,0.99],"source":"https://ascopubs.org/doi/10.1200/JCO.23.01569"}],"replication":"Consistent with other IO-TKI doublets; lenvatinib-everolimus arm improved PFS but not OS versus sunitinib."},{"id":"cleopatra","kind":"trial","name":"CLEOPATRA","aka":[],"tldr":"Adding a second HER2 antibody, pertuzumab, extended survival by 16 months, the largest gain ever seen in metastatic breast cancer at the time.","summary":"CLEOPATRA, trial NCT00567190 sponsored by Roche and Genentech and reported in 2011, showed that adding a second HER2 antibody, pertuzumab, to trastuzumab and docetaxel as first-line treatment for HER2-positive metastatic breast cancer extended survival by more than a year, the largest gain ever seen in metastatic breast cancer at the time. It randomised 808 women, met its primary progression-free survival endpoint, and its final survival analysis and eight-year landmark confirmed a durable benefit, defining the first-line regimen known as THP until DESTINY-Breast09 in 2025. OnCo links it to HER2 as a target, pertuzumab, trastuzumab, docetaxel, the dual HER2 blockade term, Sandra M. Swain, Javier Cortés and Georgetown Lombardi, and the dual blockade benefit was replicated in NeoSphere and APHINITY. Whether antibody-drug conjugates now displace THP entirely is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00567190","url":"https://clinicaltrials.gov/study/NCT00567190"}],"tags":[],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["her2"],"drugs":["pertuzumab","trastuzumab","docetaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sandra-swain","javier-cortes"],"bottlenecks":[],"keyPapers":["paper-cleopatra-n-engl-j-med-2012","paper-cleopatra-lancet-oncol-2013-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00567190","phase":"3","setting":"First-line HER2+ metastatic breast cancer: pertuzumab + trastuzumab + docetaxel vs placebo + trastuzumab + docetaxel","sponsor":"Roche / Genentech","result":"OS 57.1 vs 40.8 months, HR 0.69.","started":"2008-02-12","startedType":"actual","yearReported":2011,"enrolled":808,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Pertuzumab + trastuzumab + docetaxel","n":402,"value":18.7},{"name":"Placebo + trastuzumab + docetaxel","n":406,"value":12.4}],"hr":0.68,"ci":[0.58,0.8],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1113216"},{"endpoint":"Overall survival (final)","unit":"months","arms":[{"name":"Pertuzumab arm","value":57.1},{"name":"Placebo arm","value":40.8}],"hr":0.69,"ci":[0.58,0.82],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30863-0/fulltext"}],"replication":"Dual blockade benefit replicated in neoadjuvant (NeoSphere pCR) and adjuvant (APHINITY) settings."},{"id":"nct07197853","kind":"trial","name":"Clinical Efficacy and Safety of Microwave Ablation Combined With Huaier Granules in Patients With Inoperable Stage IA Non-Small Cell Lung Cancer: A Prospective,","aka":["HAMSTER"],"tldr":"A phase 3 trial in lung cancer, run by Xin Ye, not yet recruiting.","summary":"Clinical Efficacy and Safety of Microwave Ablation Combined With Huaier Granules in Patients With Inoperable Stage IA Non-Small Cell Lung Cancer: A Prospective, Single-Center, Randomized Controlled Clinical Trial is a phase 3, randomised interventional study registered as NCT07197853 by Xin Ye, with a registry enrolment figure of 180 participants, started 2025-10-01 and due to reach its primary completion in 2028-06-30. Interventions recorded: Huaier Granule. Conditions listed: Non-small Cell Lung Cancer (NSCLC); Huaier Granules; Microwave Ablation. Primary outcome: Progression-Free Survival (PFS). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed IA stage non-small cell lung cancer (NSCLC) that is inoperable\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07197853","url":"https://clinicaltrials.gov/study/NCT07197853"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["thermal-ablation"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07197853","phase":"3","setting":"A Prospective, Single-Center, Randomized Controlled Trial to Evaluate the Clinical Efficacy and Safety of Microwave Ablation Combined With Huaier Granules in Patients With Stage IA Non-Small Cell Lung Cancer","sponsor":"Xin Ye","started":"2025-10-01","startedType":"estimated","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06199895","kind":"trial","name":"Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholan","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Liu Huang, now recruiting.","summary":"Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer is a phase 2, interventional study registered as NCT06199895 by Liu Huang, with a registry enrolment figure of 25 participants, started 2023-11-28 and due to reach its primary completion in 2025-11. Interventions recorded: Paclitaxel Polymeric Micelles for Injection. Conditions listed: Pancreatic Adenocarcinoma; Cholangiocarcinoma; Lung Cancer; Stomach Cancer; Esophageal Carcinoma; Breast Cancer. Primary outcome: Objective Response Rate. Pancreatic eligibility wording from the registry: \"Patients with advanced pancreatic adenocarcinoma, cholangiocarcinoma, lung cancer, gastric cancer, esophageal carcinoma, or breast cancer diagnosed by histological or cytological pathology; must have an evaluable lesion; 3\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06199895","url":"https://clinicaltrials.gov/study/NCT06199895"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06199895","phase":"2","setting":"Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxanes-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer","sponsor":"Liu Huang","started":"2023-11-28","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07209384","kind":"trial","name":"Clinical Efficacy of Transarterial Chemoembolization in Elderly Patients With Advanced Unresectable Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Junpeng Wang, not yet recruiting.","summary":"Clinical Efficacy of Transarterial Chemoembolization in Elderly Patients With Advanced Unresectable Colorectal Cancer is a phase 2, interventional study registered as NCT07209384 by Junpeng Wang, with a registry enrolment figure of 50 participants, started 2025-10-01 and due to reach its primary completion in 2026-10-01. Interventions recorded: Transarterial chemoembolization. Conditions listed: Unresectable Colorectal Cancer; Advanced Malignancy; Elderly (People Aged 65 or More). Primary outcome: Objective Response Rate；Disease Control Rate. Colorectal eligibility wording from the registry: \"* Age ≥ 65 years, gender not restricted Pathologically confirmed advanced colorectal cancer without the opportunity for curative surgery Karnofsky Performance Status (KPS) score ≥ 60, with an estimated survival time ≥ 3 months At least 1 measurable colorectal lesion No prior systemic chemotherapy, o\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07209384","url":"https://clinicaltrials.gov/study/NCT07209384"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07209384","phase":"2","setting":"CLINICAL EFFICACY OF TRANSARTERIAL CHEMOEMBOLIZATION IN ELDERLY PATIENTS WITH ADVANCED UNRESECTABLE COLORECTAL CANCER","sponsor":"Junpeng Wang","started":"2025-10-01","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00822393","kind":"trial","name":"Clinical Phase III Trial Treosulfan-based Conditioning Versus Reduced-intensity Conditioning (RIC)","aka":[],"tldr":"A phase 3 trial of Busulfan and Treosulfan in Acute myeloid leukaemia, run by medac GmbH, completed.","summary":"Clinical Phase III Trial Treosulfan-based Conditioning Versus Reduced-intensity Conditioning (RIC) is a phase 3 interventional study registered as NCT00822393 by medac GmbH, with 570 participants recorded, started 2008-11-24 and reaching its primary completion in 2018-01-25. Interventions recorded: Busulfan, Treosulfan. Conditions recorded: Acute Myeloid Leukemia, Myelodysplastic Syndrome.\n\nLinked to the drug Treosulfan because the registry names it among its interventions and Acute myeloid leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00822393","url":"https://clinicaltrials.gov/study/NCT00822393"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":["busulfan","treosulfan"],"companies":["medac"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00822393","phase":"3","setting":"Clinical Phase III Trial to Compare Treosulfan-based Conditioning Therapy With Busulfan-based Reduced-intensity Conditioning (RIC) Prior to Allogeneic Haematopoietic Stem Cell Transplantation in Patients With AML or MDS Considered Ineligible to Standard Conditioning Regimens","sponsor":"medac GmbH","started":"2008-11-24","startedType":"actual","enrolled":570,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03093688","kind":"trial","name":"Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients With Advanced Solid Tumor","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Shanghai Public Health Clinical Center, now recruiting.","summary":"Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients With Advanced Solid Tumor is a phase 1/2, interventional study registered as NCT03093688 by Shanghai Public Health Clinical Center, with a registry enrolment figure of 40 participants, started 2017-03-01 and due to reach its primary completion in 2030-12-31. Interventions recorded: Infusion of iNKT cells and CD8+T cells. Conditions listed: Non-small Cell Lung Cancer; Small Cell Lung Cancer; Pancreas Cancer; Hepatocellular Carcinoma; Gastric Cancer; Renal Cell Carcinoma. Primary outcome: Incidence of adverse events related to the infusion of cells; Objective Response Rate (ORR). Pancreatic eligibility wording from the registry: \"* Histological or cytologically diagnosis of advanced lung cancer, or advanced gastric cancer, or advanced pancrease cancer, or hepatocellular carcinoma, or advanced colorectal cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03093688","url":"https://clinicaltrials.gov/study/NCT03093688"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03093688","phase":"1/2","setting":"Phace I and II Study of Immunotherapy Strategy Used iNKT Cells and CD8+T Cells in Patients With Advanced Tumor","sponsor":"Shanghai Public Health Clinical Center","started":"2017-03-01","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06825494","kind":"trial","name":"Clinical Studies for the Treatment of Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Capecitabine, Oxaliplatin, Penpulimab and Tislelizumab in advanced solid tumours, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., now recruiting.","summary":"Clinical Studies for the Treatment of Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06825494 by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., with 194 participants planned, started 2025-04-08 and due to reach its primary completion in 2026-03. Interventions recorded: LM-108 injection+Penpulimab+ Oxaliplatin+Capecitabine, Tislelizumab+Oxaliplatin+Capecitabine, LM-108 injection 10mg/kg +penpulimab, LM-108 injection 600mg + penpulimab and enpulimab+ Oxaliplatin+Capecitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06825494","url":"https://clinicaltrials.gov/study/NCT06825494"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["capecitabine","oxaliplatin","penpulimab","tislelizumab"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06825494","phase":"1/2","setting":"An Open-label Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab + Chemotherapy in Patients With Advanced Solid Tumors - Cohort A","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","started":"2025-04-08","startedType":"actual","enrolled":194,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07512583","kind":"trial","name":"Clinical Studies of TQB2930 Injection for the Treatment of Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of TQB2102 and TQB2930 in advanced solid tumours, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., now recruiting.","summary":"Clinical Studies of TQB2930 Injection for the Treatment of Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07512583 by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., with 178 participants planned, started 2026-05-27 and due to reach its primary completion in 2028-03. Interventions recorded: TQB2930 injection+TQB2102 for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07512583","url":"https://clinicaltrials.gov/study/NCT07512583"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb2102","tqb2930"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07512583","phase":"1/2","setting":"Phase Ib/II Clinical Trial of TQB2930 Injection in Combination With TQB2102 for Injection in Patients With HER2-Expressing Advanced Solid Tumors","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","started":"2026-05-27","startedType":"actual","enrolled":178,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06821503","kind":"trial","name":"Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C","aka":[],"tldr":"A phase 1/2 trial of Penpulimab and Gemcitabine in pancreatic ductal adenocarcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., now recruiting.","summary":"Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C is a phase 1/2 interventional study registered as NCT06821503 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with 72 participants planned, started 2025-04-11 and due to reach its primary completion in 2027-12. Interventions recorded: LM-108 injection, Penpulimab injection, Paclitaxel for injection (albumin bound) and Gemcitabine hydrochloride for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06821503","url":"https://clinicaltrials.gov/study/NCT06821503"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["penpulimab","gemcitabine"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06821503","phase":"1/2","setting":"An Open Label Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab Plus Chemotherapy in Patients With Advanced Solid Tumors - Cohort C","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2025-04-11","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06416852","kind":"trial","name":"Clinical Study of 18F-Alfatide Injection PET/CT","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Yantai LNC Biotechnology Singapore PTE. LTD., not yet recruiting.","summary":"Clinical Study of 18F-Alfatide Injection PET/CT is a phase 3, interventional study registered as NCT06416852 by Yantai LNC Biotechnology Singapore PTE. LTD., with a registry enrolment figure of 428 participants, started 2024-08 and due to reach its primary completion in 2026-08. Interventions recorded: 18F-Alfatide Injection; 18F-FDG Injection. Conditions listed: Non-Small Cell Lung Cancer NSCLC. Primary outcome: Sensitivity and specificity evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT. Lung eligibility wording from the registry: \"Patients with non-small cell lung cancer confirmed or highly suspected by investigators based on prior history, imaging, histopathology, and/or cytology, suspected lymph node metastasis and proposed radical surgery and lymph node dissection;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06416852","url":"https://clinicaltrials.gov/study/NCT06416852"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06416852","phase":"3","setting":"A Multicenter, Open, Non-inferiority Phase III Clinical Study to Evaluate the Efficacy of 18F-Alfatide Injection PET/CT Compared With 18F-FDG PET/CT in the Diagnosis of Lymph Node Metastasis in Non-small Cell Lung Cancer","sponsor":"Yantai LNC Biotechnology Singapore PTE. LTD.","started":"2024-08","startedType":"estimated","enrolled":428,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07522151","kind":"trial","name":"Clinical Study of Adebrelimab Therapy in the Perioperative Treatment of Gastric Cancer or Gastroesophageal Junction Cancer","aka":[],"tldr":"A phase 3 trial of Adebrelimab and Oxaliplatin in gastric & gastro-oesophageal junction cancer, run by Shanghai Shengdi Pharmaceutical Co., Ltd, now recruiting.","summary":"Clinical Study of Adebrelimab Therapy in the Perioperative Treatment of Gastric Cancer or Gastroesophageal Junction Cancer is a phase 3 interventional study registered as NCT07522151 by Shanghai Shengdi Pharmaceutical Co., Ltd, with 874 participants planned, started 2026-05-07 and due to reach its primary completion in 2029-12. Interventions recorded: Adebrelimab plus S-1 and oxaliplatin and Adebrelimab blank preparation plus S-1 and oxaliplatin..","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07522151","url":"https://clinicaltrials.gov/study/NCT07522151"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["adebrelimab","oxaliplatin"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07522151","phase":"3","setting":"A Randomized, Double-blind, Multicenter Phase III Trial of Adebrelimab (SHR-1316) Plus S-1 and Oxaliplatin (SOX) Versus Placebo Plus S-1 and Oxaliplatin in the Perioperative Treatment of Resectable Gastric or Gastroesophageal Junction Cancer","sponsor":"Shanghai Shengdi Pharmaceutical Co., Ltd","started":"2026-05-07","startedType":"actual","enrolled":874,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06680752","kind":"trial","name":"Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS","aka":[],"tldr":"A phase 1/2 trial of Cyclophosphamide and Fludarabine in acute myeloid leukaemia and myelodysplastic syndromes / neoplasms, run by ARCE Therapeutics, Inc., now recruiting.","summary":"Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS is a phase 1/2 interventional study registered as NCT06680752 by ARCE Therapeutics, Inc., with 49 participants planned, started 2025-05-20 and due to reach its primary completion in 2028-10. Interventions recorded: ARD103, Cyclophosphamide and Fludarabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06680752","url":"https://clinicaltrials.gov/study/NCT06680752"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","mds"],"sections":[],"technologies":[],"targets":[],"drugs":["cyclophosphamide","fludarabine","ard103"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06680752","phase":"1/2","setting":"A Phase 1/2, Open-label, Multicenter Trial to Assess the Safety and Efficacy of ARD103 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome","sponsor":"ARCE Therapeutics, Inc.","started":"2025-05-20","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05475678","kind":"trial","name":"Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Zhenzhen Liu, now recruiting.","summary":"Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer is a phase 2, randomised interventional study registered as NCT05475678 by Zhenzhen Liu, with a registry enrolment figure of 369 participants, started 2022-12-20 and due to reach its primary completion in 2025-05-31. Interventions recorded: （Carrelizumab + TCb） regimen; TCb regimen. Conditions listed: Breast Cancer; Triple Negative Breast Cancer; Camrelizumab. Triple-negative eligibility wording from the registry: \"Pathologically proven triple negative breast cancer:\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05475678","url":"https://clinicaltrials.gov/study/NCT05475678"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05475678","phase":"2","setting":"A Randomized, Open Label, Parallel Controlled, Multicenter Phase II Clinical Study of Carelizumab Combined With TCb (Docetaxel+Carboplatin) Versus TCb Neoadjuvant Therapy for Triple Negative Breast Cancer","sponsor":"Zhenzhen Liu","started":"2022-12-20","startedType":"actual","enrolled":369,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06167694","kind":"trial","name":"Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of Dalpiciclib and HRS-8080 in advanced solid tumours, run by Shandong Suncadia Medicine Co., Ltd., now recruiting.","summary":"Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer is a phase 1/2 interventional study registered as NCT06167694 by Shandong Suncadia Medicine Co., Ltd., with 146 participants planned, started 2023-12-20 and due to reach its primary completion in 2026-06. Interventions recorded: HRS-8080; Dalpiciclib Isethionate Tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06167694","url":"https://clinicaltrials.gov/study/NCT06167694"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["dalpiciclib","hrs-8080"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06167694","phase":"1/2","setting":"A Multicenter, Open Phase Ib/II Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With ER-positive, HER2-negative Unresectable or Metastatic Breast Cancer","sponsor":"Shandong Suncadia Medicine Co., Ltd.","started":"2023-12-20","startedType":"actual","enrolled":146,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07044921","kind":"trial","name":"Clinical Study of Irinotecan Liposome (II)-Based Combination Treatment for Irinotecan-resistant Colorectal Cancer.","aka":[],"tldr":"A phase 2 trial of cetuximab in colorectal cancer, run by Chinese PLA General Hospital, now recruiting.","summary":"Clinical Study of Irinotecan Liposome (II)-Based Combination Treatment for Irinotecan-resistant Colorectal Cancer. is a phase 2, interventional study registered as NCT07044921 by Chinese PLA General Hospital, with a registry enrolment figure of 30 participants, started 2024-09-01 and due to reach its primary completion in 2026-07-31. Interventions recorded: Irinotecan Liposomes (II)+Cetuximab+Bevacizumabl. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: PFS. Colorectal eligibility wording from the registry: \"* patients with pathologically confirmed advanced colorectal cancer(excluding all other histological types);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07044921","url":"https://clinicaltrials.gov/study/NCT07044921"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07044921","phase":"2","setting":"A Single-center Phase II Clinical Study of Irinotecan Liposome (II)-Based Combination Regimen as a Treatment for Irinotecan-Resistant Colorectal Cancer.","sponsor":"Chinese PLA General Hospital","started":"2024-09-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06767514","kind":"trial","name":"Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1","aka":["HARMONi-7"],"tldr":"A phase 3 trial of Ivonescimab, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Summit Therapeutics, now recruiting.","summary":"Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1 is a phase 3 interventional study registered as NCT06767514 by Summit Therapeutics, with 780 participants planned, started 2025-02-27 and due to reach its primary completion in 2028-04. Interventions recorded: Ivonescimab Injection, Pembrolizumab Injection. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06767514","url":"https://clinicaltrials.gov/study/NCT06767514"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pdl1-high-nsclc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab","pembrolizumab"],"companies":["summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06767514","phase":"3","setting":"A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression","sponsor":"Summit Therapeutics","started":"2025-02-27","startedType":"actual","enrolled":780,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04668690","kind":"trial","name":"Clinical Study of Mitoxantrone Hydrochloride Liposome Injection vs. Chidamide in Patients With Relapsed/Refractory PTCL","aka":[],"tldr":"A phase 3 trial of Mitoxantrone and Tucidinostat (chidamide) in peripheral T-cell lymphomas, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., active and no longer recruiting.","summary":"Clinical Study of Mitoxantrone Hydrochloride Liposome Injection vs. Chidamide in Patients With Relapsed/Refractory PTCL is a phase 3 interventional study registered as NCT04668690 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., with 193 participants enrolled, started 2021-04-13 and due to reach its primary completion in 2027-12-30. Interventions recorded: Mitoxantrone Hydrochloride Liposome Injection and Chidamide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04668690","url":"https://clinicaltrials.gov/study/NCT04668690"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs","topoisomerase-inhibitors"],"targets":[],"drugs":["mitoxantrone","tucidinostat"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04668690","phase":"3","setting":"A Randomized, Open-label, Active Controlled, Multi-center Phase 3 Clinical Study to Compare the Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection With Chidamide in Patients With Relapsed/Refractory PTCL.","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","started":"2021-04-13","startedType":"actual","enrolled":193,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06828757","kind":"trial","name":"Clinical Study of Nanocrystalline Megestrol in Malnourished Patients With First-Line Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Hunan Province Tumor Hospital, not yet recruiting.","summary":"Clinical Study of Nanocrystalline Megestrol in Malnourished Patients With First-Line Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT06828757 by Hunan Province Tumor Hospital, with a registry enrolment figure of 94 participants, started 2025-05-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: nanocrystalline megestrol oral suspension + PD-1/L1 inhibitor combined with chemotherapy; PD-1/L1 inhibitor combined with chemotherapy. Conditions listed: Non Small Cell Lung Cancer. Primary outcome: Appetite improvement level; Weight improvement level. Lung eligibility wording from the registry: \"(5) According to the 8th edition of the TNM stage classification of lung cancer with histological or cytologic evidence that cannot undergo complete surgical resection and cannot undergo radical synchronous/sequential chemoradiation and treatment ( IIIB/IIIC phase), metastatic (IV phase) NSCLC\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06828757","url":"https://clinicaltrials.gov/study/NCT06828757"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06828757","phase":"3","setting":"A Phase III Prospective, Randomized, Parallel-Controlled Clinical Study of Nanocrystalline Megestrol in Malnourished Patients With First-Line Non-Small Cell Lung Cancer","sponsor":"Hunan Province Tumor Hospital","started":"2025-05-01","startedType":"estimated","enrolled":94,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07005583","kind":"trial","name":"Clinical Study of QL1706 in Combination With Olaparib for the Treatment of Patients With Previously Treated Homologous Recombination Repair-Deficient Recurrent","aka":[],"tldr":"A phase 2 trial of iparomlimab and tuvonralimab and olaparib in triple-negative breast cancer, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"Clinical Study of QL1706 in Combination With Olaparib for the Treatment of Patients With Previously Treated Homologous Recombination Repair-Deficient Recurrent or Metastatic Triple-Negative Breast Cancer is a phase 2, interventional study registered as NCT07005583 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 46 participants, started 2025-06-30 and due to reach its primary completion in 2027-05-30. Interventions recorded: QL1706 Plus Olaparib. Conditions listed: Triple-Negative Breast Cancer (TNBC). Triple-negative eligibility wording from the registry: \"Female breast cancer patients aged ≥18 and ≤75 years, with histologically or cytologically confirmed recurrent or metastatic triple-negative breast cancer (TNBC) as defined by the latest ASCO/CAP guidelines (based on the most recent biopsy or other pathological specimens)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07005583","url":"https://clinicaltrials.gov/study/NCT07005583"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["iparomlimab-tuvonralimab","olaparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07005583","phase":"2","setting":"Clinical Study of QL1706 in Combination With Olaparib for the Treatment of Patients With Previously Treated Homologous Recombination Repair-Deficient Recurrent or Metastatic Triple-Negative Breast Cancer","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2025-06-30","startedType":"estimated","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07827053","kind":"trial","name":"Clinical Study of Radiotherapy Combined With Adebrelimab and NALIRIFOX for Conversion Therapy in Locally Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of adebrelimab and nALIRIFOX (liposomal irinotecan + oxaliplatin + 5-FU/LV) in pancreatic cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, not yet recruiting.","summary":"Clinical Study of Radiotherapy Combined With Adebrelimab and NALIRIFOX for Conversion Therapy in Locally Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT07827053 by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, with a registry enrolment figure of 36 participants, started 2026-09-01 and due to reach its primary completion in 2029-09-01. Interventions recorded: Adebrelimab (PD-L1 inhibitor); NALIRIFOX; SBRT. Conditions listed: Pancreatic Ductal Adenocarcinoma (PDAC). Primary outcome: surgical conversion rate. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed pancreatic ductal adenocarcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07827053","url":"https://clinicaltrials.gov/study/NCT07827053"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","sbrt","topoisomerase-inhibitors"],"targets":[],"drugs":["adebrelimab","nalirifox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07827053","phase":"2","setting":"Clinical Study of Radiotherapy Combined With Adebrelimab and NALIRIFOX for Conversion Therapy in Locally Advanced Pancreatic Cancer","sponsor":"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","started":"2026-09-01","startedType":"estimated","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06540326","kind":"trial","name":"Clinical Study of Second-line Treatment in Advanced Colorectal Cancer With Chemotherapy With Bevacizumab or Cetuximab","aka":[],"tldr":"A phase 2 trial of fluorouracil (5-FU), cetuximab, bevacizumab (glioblastoma use) and capecitabine in colorectal cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"Clinical Study of Second-line Treatment in Advanced Colorectal Cancer With Chemotherapy With Bevacizumab or Cetuximab is a phase 2, interventional study registered as NCT06540326 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 100 participants, started 2024-11-12 and due to reach its primary completion in 2026-04-15. Interventions recorded: irinotecan liposome (II); fluorouracil; cetuximab; bevacizumab; Capecitabine. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed metastatic colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06540326","url":"https://clinicaltrials.gov/study/NCT06540326"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["fluorouracil","cetuximab","bevacizumab-glioma","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06540326","phase":"2","setting":"Clinical Study of Second-line Treatment of Patients With Advanced Colorectal Cancer With Irinotecan Liposome (II), Fluorouracil in Combination With Bevacizumab or Cetuximab","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2024-11-12","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06195670","kind":"trial","name":"Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine as First Line Treatment in Advanced mCRC","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by Zhejiang Cancer Hospital, not yet recruiting.","summary":"Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine as First Line Treatment in Advanced mCRC is a phase 1/2, randomised interventional study registered as NCT06195670 by Zhejiang Cancer Hospital, with a registry enrolment figure of 220 participants, started 2024-01 and due to reach its primary completion in 2026-01. Interventions recorded: Experimental; Active Comparator. Conditions listed: CRC; Metastatic Colorectal Cancer; Metastatic Colorectal Adenocarcinoma. Primary outcome: Phase 1b - Objective Response Rate (ORR); Phase 2 - Progression-free Survival (PFS). Colorectal eligibility wording from the registry: \"* Histopathologically confirmed unresectable advanced metastatic colorectal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06195670","url":"https://clinicaltrials.gov/study/NCT06195670"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06195670","phase":"1/2","setting":"An Open-label, Multi-centered, Two-stage Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine in the First Line Treatment of Advanced mCRC Patients Unfit for Intense Therapy","sponsor":"Zhejiang Cancer Hospital","started":"2024-01","startedType":"estimated","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05802225","kind":"trial","name":"Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer","aka":["PREFER"],"tldr":"A phase 3 trial of Pertuzumab in HER2-positive breast cancer, run by Biocad, active and no longer recruiting.","summary":"Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer is a phase 3 interventional study registered as NCT05802225 by Biocad, with 398 participants enrolled, started 2023-01-30 and due to reach its primary completion in 2025-06-06. Interventions recorded: BCD-178 and Perjeta.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05802225","url":"https://clinicaltrials.gov/study/NCT05802225"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["pertuzumab"],"companies":["biocad"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05802225","phase":"3","setting":"A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer","sponsor":"Biocad","started":"2023-01-30","startedType":"actual","enrolled":398,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06640530","kind":"trial","name":"Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin","aka":["UNIVERSE"],"tldr":"A phase 3 trial of Nivolumab in melanoma, run by Biocad, active and no longer recruiting.","summary":"Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin is a phase 3 interventional study registered as NCT06640530 by Biocad, with 392 participants planned, started 2024-03-21 and due to reach its primary completion in 2025-12. Interventions recorded: BCD-263, Opdivo. Conditions listed: Advanced Melanoma, Melanoma (Skin). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06640530","url":"https://clinicaltrials.gov/study/NCT06640530"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["biocad"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06640530","phase":"3","setting":"A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin","sponsor":"Biocad","started":"2024-03-21","startedType":"actual","enrolled":392,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02628665","kind":"trial","name":"Clinical Study of Time Optimizing of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer","aka":[],"tldr":"A phase 3 trial of Porfimer sodium in Oesophageal and junctional adenocarcinoma and Oesophageal squamous cell carcinoma, run by The First Affiliated Hospital of Henan University of Science and Technology, with a status the registry has not verified recently.","summary":"Clinical Study of Time Optimizing of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer is a phase 3 interventional study registered as NCT02628665 by The First Affiliated Hospital of Henan University of Science and Technology, with 40 participants planned, started 2015-10 and due to reach its primary completion in 2017-10. Interventions recorded: photosensitizer(photofrin), 630 nm laser irradiation (DIOMED). Conditions recorded: Stage I Esophageal Adenocarcinoma, Stage II Esophageal Adenocarcinoma, Stage III Esophageal Adenocarcinoma, Stage I Esophageal Squamous Cell Carcinoma, Stage II Esophageal Squamous Cell Carcinoma, Stage III Esophageal Squamous Cell Carcinoma.\n\nLinked to the drug Porfimer sodium because the registry names it among its interventions and Oesophageal and junctional adenocarcinoma and Oesophageal squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02628665","url":"https://clinicaltrials.gov/study/NCT02628665"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["oesophageal-adenocarcinoma","oesophageal-squamous-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["porfimer-sodium"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02628665","phase":"3","setting":"Two-arm Phase III Trial Comparing Different Time of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer","sponsor":"The First Affiliated Hospital of Henan University of Science and Technology","started":"2015-10","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06767813","kind":"trial","name":"Clinical Study of TQB2868 Injection Combined With Anlotinib Capsule and Chemotherapy in the First-line Treatment of Metastatic Pancreatic Neoplasms","aka":[],"tldr":"A phase 2 trial of Gemcitabine and Anlotinib in pancreatic ductal adenocarcinoma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., now recruiting.","summary":"Clinical Study of TQB2868 Injection Combined With Anlotinib Capsule and Chemotherapy in the First-line Treatment of Metastatic Pancreatic Neoplasms is a phase 2 interventional study registered as NCT06767813 by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., with 80 participants planned, started 2024-03-19 and due to reach its primary completion in 2026-11. Interventions recorded: TQB2868 injection, Gemcitabine injection, Albumin paclitaxel injection and Anlotinib capsules.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06767813","url":"https://clinicaltrials.gov/study/NCT06767813"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["gemcitabine","anlotinib","tqb2868"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06767813","phase":"2","setting":"Multi-cohort, Open, Phase II Clinical Study of TQB2868 Injection Combined With Arotinib Capsule and Chemotherapy in the First-line Treatment of Pancreatic Neoplasms","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","started":"2024-03-19","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05653453","kind":"trial","name":"Clinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial of Gemcitabine in pancreatic ductal adenocarcinoma, run by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd, now recruiting.","summary":"Clinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer is a phase 3 interventional study registered as NCT05653453 by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd, with 512 participants planned, started 2022-12-20 and due to reach its primary completion in 2026-12-25. Interventions recorded: Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel and Gemcitabine hydrochloride and albumin binding paclitaxel.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05653453","url":"https://clinicaltrials.gov/study/NCT05653453"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05653453","phase":"3","setting":"Clinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer","sponsor":"Jiangsu Healthy Life Innovation Medical Technology Co., Ltd","started":"2022-12-20","startedType":"actual","enrolled":512,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05768529","kind":"trial","name":"Clinical Study of U16 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma","aka":[],"tldr":"A phase 1/2 trial of U16 in non-Hodgkin lymphoma, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd, now recruiting.","summary":"Clinical Study of U16 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma is a phase 1/2 interventional study registered as NCT05768529 by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd, with 100 participants planned, started 2023-03-28 and due to reach its primary completion in 2024-12-31. Interventions recorded: U16.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05768529","url":"https://clinicaltrials.gov/study/NCT05768529"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["unicar-therapy"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05768529","phase":"1/2","setting":"A Single-arm, Open and Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of U16 Injection in the Treatment of Refractory/Recurrent B-cell Non-Hodgkin's Lymphoma (r/r B-NHL)","sponsor":"Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd","started":"2023-03-28","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07036250","kind":"trial","name":"Clinical Study of U32 in Patients With Acute Myeloid Leukemia","aka":[],"tldr":"A phase 1/2 trial of U32 CAR-T in acute myeloid leukaemia, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd, now recruiting.","summary":"Clinical Study of U32 in Patients With Acute Myeloid Leukemia is a phase 1/2 interventional study registered as NCT07036250 by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd, with 20 participants planned, started 2025-07-03 and due to reach its primary completion in 2027-12-31. Interventions recorded: U32 CAR-T.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07036250","url":"https://clinicaltrials.gov/study/NCT07036250"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":[],"companies":["unicar-therapy"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07036250","phase":"1/2","setting":"A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U32 Injection in Patients With Acute Myeloid Leukemia.","sponsor":"Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd","started":"2025-07-03","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06126510","kind":"trial","name":"Clinical Study of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma","aka":[],"tldr":"A phase 2 trial of Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell) in sarcomas, run by CNBG-Virogin Biotech (Shanghai) Ltd., now recruiting.","summary":"Clinical Study of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma is a phase 2 interventional study registered as NCT06126510 by CNBG-Virogin Biotech (Shanghai) Ltd., with 40 participants planned, started 2023-07-18 and due to reach its primary completion in 2025-07-17. Interventions recorded: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06126510","url":"https://clinicaltrials.gov/study/NCT06126510"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06126510","phase":"2","setting":"A Single-arm, Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma","sponsor":"CNBG-Virogin Biotech (Shanghai) Ltd.","started":"2023-07-18","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07730515","kind":"trial","name":"Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma","aka":[],"tldr":"A phase 1/2 trial of Cyclophosphamide, Doxorubicin, Vincristine in hodgkin lymphoma and non-hodgkin lymphoma, run by Evopoint Biosciences Inc., now recruiting.","summary":"Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma is a phase 1/2 interventional study registered as NCT07730515 by Evopoint Biosciences Inc., with 176 participants planned, started 2025-08-15 and due to reach its primary completion in 2028-09-30. Interventions recorded: XNW5004 combined with CHOP (incremental), XNW5004 combined with CHOEP (incremental), XNW5004 combined with CHOP (extended), XNW5004 combined with CHOEP (extended). Conditions listed: Non-hodgkin Lymphoma, Peripheral T-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07730515","url":"https://clinicaltrials.gov/study/NCT07730515"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma","peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["cyclophosphamide","doxorubicin","vincristine","prednisone","xnw5004","etoposide"],"companies":["evopoint-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07730515","phase":"1/2","setting":"A Phase Ib/II Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma","sponsor":"Evopoint Biosciences Inc.","started":"2025-08-15","startedType":"actual","enrolled":176,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07545603","kind":"trial","name":"Clinical Study of XNW5004 Tablets in the Treatment of Relapsed and Refractory Follicular Lymphoma","aka":[],"tldr":"A phase 2 trial of XNW5004 in follicular lymphoma, run by Evopoint Biosciences Inc., now recruiting.","summary":"Clinical Study of XNW5004 Tablets in the Treatment of Relapsed and Refractory Follicular Lymphoma is a phase 2 interventional study registered as NCT07545603 by Evopoint Biosciences Inc., with 65 participants planned, started 2026-02-14 and due to reach its primary completion in 2027-12-31. Interventions recorded: XNW5004 tablets. Conditions listed: Follicular Lymphoma, Grade 1, Follicular Lymphoma, Grade 2, Follicular Lymphoma, Grade 3, Follicular Lymphoma Grade 3A. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07545603","url":"https://clinicaltrials.gov/study/NCT07545603"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["xnw5004"],"companies":["evopoint-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07545603","phase":"2","setting":"Phase II Study of XNW5004 in the Treatment of Patients With Relapsed or Refractory Follicular Lymphoma (EZH2 Wild-type)","sponsor":"Evopoint Biosciences Inc.","started":"2026-02-14","startedType":"actual","enrolled":65,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05780567","kind":"trial","name":"Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer","aka":[],"tldr":"A phase 3 trial testing TQB3616 in HR-positive / HER2-negative breast cancer, active and no longer recruiting.","summary":"Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer is a phase 3 interventional study registered as NCT05780567, led by Chia Tai Tianqing Pharmaceutical, and active but no longer recruiting on the registry. Official title: Randomised, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of TQB3616 Combined With Endocrine Therapy Versus Placebo Combined With Endocrine Therapy in Hormone Receptors (HR)-Positive and Human Epidermal GrowthFactor Receptor-2 (HER2) -Negative Breast Cancer Adjuvant Therapy. Planned enrolment is 1946 participants (estimated). The study started in 2023-03-30 and primary completion is expected in 2026-12. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05780567","url":"https://clinicaltrials.gov/study/NCT05780567"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb3616"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05780567","phase":"3","setting":"Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of TQB3616 Combined With Endocrine Therapy Versus Placebo Combined With Endocrine Therapy in Hormone Receptors (HR)-Positive and Human Epidermal GrowthFactor Receptor-2 (HER2) -Negative Breast Cancer Adjuvant Therapy","sponsor":"Chia Tai Tianqing Pharmaceutical","started":"2023-03-30","startedType":"actual","enrolled":1946,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06961188","kind":"trial","name":"Clinical Study on Nanocrystalline Megestrol Acetate for Appetite Improvement and Weight Gain in Pre-Cachexia and Cachexia Stages Key Terminology Analysis","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Changchun GeneScience Pharmaceutical Co., Ltd., not yet recruiting.","summary":"Clinical Study on Nanocrystalline Megestrol Acetate for Appetite Improvement and Weight Gain in Pre-Cachexia and Cachexia Stages Key Terminology Analysis is a phase 3, randomised interventional study registered as NCT06961188 by Changchun GeneScience Pharmaceutical Co., Ltd., with a registry enrolment figure of 174 participants, started 2025-06-01 and due to reach its primary completion in 2027-06-30. Interventions recorded: Nano-crystalline Megestrol Acetate Oral Suspension; Standard Therapy. Conditions listed: Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity; Untreated With Systemic Therapy. Primary outcome: Proportion of appetite improvement assessed by A/CS-12 (Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy); Proportion of individuals with weight gain exceeding 5% relative to baseline. Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed metastatic (stage IV) driver gene-negative non-squamous non-small cell lung cancer (NSCLC) that is unresectable and not amenable to curative therapy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06961188","url":"https://clinicaltrials.gov/study/NCT06961188"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["changchun-genescience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06961188","phase":"3","setting":"Clinical Study on Nanocrystalline Megestrol Acetate for Appetite Improvement and Weight Gain in First-Line Non-Squamous Non-Small Cell Lung Cancer Patients During Pre-Cachexia and Cachexia Stages.","sponsor":"Changchun GeneScience Pharmaceutical Co., Ltd.","started":"2025-06-01","startedType":"estimated","enrolled":174,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05009836","kind":"trial","name":"Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC","aka":["SANOVO"],"tldr":"A phase 3 trial of Savolitinib in non-small-cell lung cancer and small-cell lung cancer, run by Hutchmed, active and no longer recruiting.","summary":"Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC is a phase 3 interventional study registered as NCT05009836 by Hutchmed, with 412 participants planned, started 2021-09-06 and due to reach its primary completion in 2028-05-30. Interventions recorded: Savolitinib, Placebo. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05009836","url":"https://clinicaltrials.gov/study/NCT05009836"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["savolitinib"],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05009836","phase":"3","setting":"A Multicenter, Randomized, Double-blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Savolitinib + Osimertinib Versus Placebo + Osimertinib as the First Line Therapy for Patients With EGFRm+/MET+ NSCLC","sponsor":"Hutchmed","started":"2021-09-06","startedType":"actual","enrolled":412,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07385703","kind":"trial","name":"Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma","aka":[],"tldr":"A phase 3 trial testing LM-302 in gastric & gastro-oesophageal junction cancer, now recruiting.","summary":"Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma is a phase 3 interventional study registered as NCT07385703, led by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development, and recruiting on the registry. Official title: A Randomised, Open-Label, Multicenter Phase III Study of Tecotabart Vedotin Plus Tislelizumab Versus Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With CLDN18.2-Positive, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma. Planned enrolment is 752 participants (estimated). The study started in 2026-04-15 and primary completion is expected in 2028-10. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07385703","url":"https://clinicaltrials.gov/study/NCT07385703"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gastric","gastric-cldn18-2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["lm-302"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07385703","phase":"3","setting":"A Randomized, Open-Label, Multicenter Phase III Study of Tecotabart Vedotin Plus Tislelizumab Versus Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With CLDN18.2-Positive, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","sponsor":"Shanghai Chia Tai Tianqing Pharmaceutical Technology Development","started":"2026-04-15","startedType":"actual","enrolled":752,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07391618","kind":"trial","name":"Clinical Study on the First-line Treatment of Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Chinese PLA General Hospital, now recruiting.","summary":"Clinical Study on the First-line Treatment of Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU is a phase 2, interventional study registered as NCT07391618 by Chinese PLA General Hospital, with a registry enrolment figure of 583 participants, started 2025-05-15 and due to reach its primary completion in 2028-12. Interventions recorded: mFOLFOX/FOLFIRI ( Standard Chemotherapy). Conditions listed: Advanced Colorectal Cancer. Primary outcome: PFS. Colorectal eligibility wording from the registry: \"Patients with unresectable or metastatic colorectal cancer confirmed by histology or cytology, where the primary tumor location and the status of RAS and BRAF are known;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07391618","url":"https://clinicaltrials.gov/study/NCT07391618"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07391618","phase":"2","setting":"A Study to Evaluate the Efficacy and Safety of a First-line Treatment for Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU","sponsor":"Chinese PLA General Hospital","started":"2025-05-15","startedType":"actual","enrolled":583,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06879145","kind":"trial","name":"Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)","aka":[],"tldr":"A phase 2/3 trial of Adebrelimab and SHR-A2102 in bladder & urothelial cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316) is a phase 2/3 interventional study registered as NCT06879145 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 840 participants planned, started 2025-04-25 and due to reach its primary completion in 2031-12. Interventions recorded: SHR-A2102；Adebrelimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06879145","url":"https://clinicaltrials.gov/study/NCT06879145"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["adebrelimab","shr-a2102"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06879145","phase":"2/3","setting":"A Randomized, Open, Multicenter Phase II/III Clinical Study of SHR-A2102 for Injection Combined With Adebrelimab (SHR-1316) in Perioperative Treatment of Muscular Invasive Bladder Cancer (MIBC)","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-04-25","startedType":"actual","enrolled":840,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03067051","kind":"trial","name":"Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System","aka":[],"tldr":"A phase 1/2 trial of Verteporfin in prostate cancer, run by SpectraCure AB, now recruiting.","summary":"Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System is a phase 1/2 interventional study registered as NCT03067051 by SpectraCure AB, with 66 participants planned, started 2017-03-21 and due to reach its primary completion in 2027-07-31. Interventions recorded: Verteporfin and SpectraCure P18 System.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03067051","url":"https://clinicaltrials.gov/study/NCT03067051"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["spectracure"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03067051","phase":"1/2","setting":"Open-label Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System (Interstitial Multiple Diode Lasers and IDOSE® Software) and Verteporfin for Injection (VFI) for the Treatment of Recurrent Prostate Cancer","sponsor":"SpectraCure AB","started":"2017-03-21","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07122063","kind":"trial","name":"Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SYS6045 in advanced solid tumours, run by CSPC Megalith Biopharmaceutical Co.,Ltd., active and no longer recruiting.","summary":"Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors is a phase 1/2 interventional study registered as NCT07122063 by CSPC Megalith Biopharmaceutical Co.,Ltd., with 266 participants enrolled, started 2025-08-11 and due to reach its primary completion in 2027-07-30. Interventions recorded: SYS6045.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07122063","url":"https://clinicaltrials.gov/study/NCT07122063"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07122063","phase":"1/2","setting":"A Multicenter, Open-Label Phase I/II Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors","sponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","started":"2025-08-11","startedType":"actual","enrolled":266,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06233877","kind":"trial","name":"Clinical Trial Evaluating Low Dose G-FLIP Plus Mitomycin C for Stage IV Pancreatic Cancer","aka":["GFLIPM"],"tldr":"A phase 2 trial of mitomycin C in pancreatic cancer, run by Hirschfeld Oncology, not yet recruiting.","summary":"Clinical Trial Evaluating Low Dose G-FLIP Plus Mitomycin C for Stage IV Pancreatic Cancer is a phase 2, interventional study registered as NCT06233877 by Hirschfeld Oncology, with a registry enrolment figure of 60 participants, started 2024-03-15 and due to reach its primary completion in 2027-01-31. Interventions recorded: G-GLIP plus Mitomycin C. Conditions listed: Pancreatic Cancer. Primary outcome: Overall Survival; Response Rate. Pancreatic eligibility wording from the registry: \"* Histologically confirmed metastatic (Stage IV) pancreatic adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06233877","url":"https://clinicaltrials.gov/study/NCT06233877"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["mitomycin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06233877","phase":"2","setting":"An Open Label Phase 2 Trial to Evaluate the Safety, Tolerability, and Efficacy of Low Dose G-FLIP in Combination With Mitomycin C in Patients With Stage IV Pancreatic Cancer Who Have Failed First-Line Treatment","sponsor":"Hirschfeld Oncology","started":"2024-03-15","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07192068","kind":"trial","name":"Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.","aka":["AcSé HER2"],"tldr":"A phase 2 trial of zanidatamab in colorectal cancer, run by UNICANCER, now recruiting.","summary":"Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene. is a phase 2, interventional study registered as NCT07192068 by UNICANCER, with a registry enrolment figure of 105 participants, started 2025-10-30 and due to reach its primary completion in 2028-03-13. Interventions recorded: Zanidatamab. Conditions listed: Non-Small Cell Lung Cancer; Sarcoma; Head &Amp; Neck Cancer; Colorectal Carcinoma; Endometrial. Primary outcome: Confirmed Objective Response Rate (ORR) by investigator. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed endometrial, colorectal, head \\& neck, non-small cell lung cancer (NSCLC), or sarcoma\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07192068","url":"https://clinicaltrials.gov/study/NCT07192068"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","her2-amplified-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["zanidatamab"],"companies":["jazz","unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07192068","phase":"2","setting":"Widening Treatment Options Among Adult Patients With HER2-overexpressing or Mutant Solid Cancers.","sponsor":"UNICANCER","started":"2025-10-30","startedType":"actual","enrolled":105,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07683949","kind":"trial","name":"Clinical Trial Evaluating the Efficacy of Capecitabine Plus Lenvatinib in Patients With Advanced Colorectal Cancer Refractory to Irinotecan, Oxaliplatin, and Fl","aka":["LENCAP-CRC"],"tldr":"A phase 1/2 trial in colorectal cancer, run by Seoul National University Bundang Hospital, now recruiting.","summary":"Clinical Trial Evaluating the Efficacy of Capecitabine Plus Lenvatinib in Patients With Advanced Colorectal Cancer Refractory to Irinotecan, Oxaliplatin, and Fluoropyrimidine is a phase 1/2, interventional study registered as NCT07683949 by Seoul National University Bundang Hospital, with a registry enrolment figure of 93 participants, started 2026-06-15 and due to reach its primary completion in 2029-10-31. Interventions recorded: Lenvanib (Lenvatinib),Xeloda (capecitabine). Conditions listed: Advanced Colorectal Cancer (Part 1). Primary outcome: Primary Efficacy Analysis. Colorectal eligibility wording from the registry: \"* 1\\) Voluntarily signed written informed consent 2) Male or female ≥19 years of age 3) Histologically confirmed metastatic or unresectable colorectal adenocarcinoma 4) Metastatic colorectal cancer refractory to irinotecan, oxaliplatin, and fluoropyrimidines 5) ECOG performance status 0, 1, or 2 6) \". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07683949","url":"https://clinicaltrials.gov/study/NCT07683949"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07683949","phase":"1/2","setting":"A Phase I/II Clinical Trial Evaluating the Efficacy of Capecitabine Plus Lenvatinib in Patients With Advanced Colorectal Cancer Refractory to Irinotecan, Oxaliplatin, and Fluoropyrimidine","sponsor":"Seoul National University Bundang Hospital","started":"2026-06-15","startedType":"estimated","enrolled":93,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07367516","kind":"trial","name":"Clinical Trial Evaluating TQB6411 Injection in Participant s With Esophageal Cancer","aka":[],"tldr":"A phase 1/2 trial of TQB6411 in oesophageal cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., now recruiting.","summary":"Clinical Trial Evaluating TQB6411 Injection in Participant s With Esophageal Cancer is a phase 1/2 interventional study registered as NCT07367516 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with 105 participants planned, started 2026-02-12 and due to reach its primary completion in 2027-02. Interventions recorded: TQB6411 Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07367516","url":"https://clinicaltrials.gov/study/NCT07367516"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb6411"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07367516","phase":"1/2","setting":"A Phase Ib/II Clinical Trial Evaluating the Safety and Efficacy of TQB6411 Injection in Participant s With Recurrent or Metastatic Esophageal Cancer Who Have Failed Prior PD-1/PD-L1 Inhibitor Plus Platinum-Based Chemotherapy","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2026-02-12","startedType":"actual","enrolled":105,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06255912","kind":"trial","name":"Clinical Trial for Advanced or Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, not yet recruiting.","summary":"Clinical Trial for Advanced or Metastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT06255912 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 26 participants, started 2024-03-01 and due to reach its primary completion in 2029-03-01. Interventions recorded: LTC004 + MIL-97; LTC004 + MIL-97+chemotherapy. Conditions listed: Pancreas Cancer. Primary outcome: Dose Limiting Toxicity; Maximum tolerated dose Tolerated Dose Dose; Treatment Emergent Adverse Events. Pancreatic eligibility wording from the registry: \"Patients with inoperable advanced pancreatic cancer who have experienced progression during or after receiving at least one systemic treatment line, including the modified FOLFIRINOX regimen, capecitabine and/or gemcitabine, erlotinib, with or without platinum agents (oxaliplatin, cisplatin, or carb\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06255912","url":"https://clinicaltrials.gov/study/NCT06255912"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06255912","phase":"2","setting":"A Phase II Clinical Trial Assessing the Safety, Tolerability, and Pharmacokinetics of LTC004 in Combination With MIL-97 ± Chemotherapy in Patients With Advanced or Metastatic Pancreatic Cancer","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2024-03-01","startedType":"estimated","enrolled":26,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05230810","kind":"trial","name":"Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.","aka":[],"tldr":"A phase 1/2 trial of Alpelisib, Tucatinib and Fulvestrant in HER2-positive breast cancer, run by Criterium, Inc., active and no longer recruiting.","summary":"Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. is a phase 1/2 interventional study registered as NCT05230810 by Criterium, Inc., with 40 participants enrolled, started 2022-08-25 and due to reach its primary completion in 2026-03-30. Interventions recorded: Alpelisib, Tucatinib and Fulvestrant.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05230810","url":"https://clinicaltrials.gov/study/NCT05230810"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["alpelisib","tucatinib","fulvestrant"],"companies":["novartis","pfizer","criterium"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05230810","phase":"1/2","setting":"This is a Multicenter, Single Arm, Open-label, run-in Phase Ib / Roll-over Phase II Study of Tucatinib in Combination With Alpelisib in Subjects With PIK3CA-mutant HER2-positive Locally Advanced Unresectable or Metastatic Breast Cancer.","sponsor":"Criterium, Inc.","started":"2022-08-25","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02781883","kind":"trial","name":"Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML","aka":[],"tldr":"A phase 2 trial of Decitabine in acute myeloid leukaemia, run by Bio-Path Holdings, Inc., now recruiting.","summary":"Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML is a phase 2 interventional study registered as NCT02781883 by Bio-Path Holdings, Inc., with 108 participants planned, started 2016-05 and due to reach its primary completion in 2027-12. Interventions recorded: BP1001 in combination with Ventoclax plus decitabine and BP1001 plus decitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02781883","url":"https://clinicaltrials.gov/study/NCT02781883"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-older-unfit"],"sections":[],"technologies":["epigenetic-drugs"],"targets":[],"drugs":["decitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02781883","phase":"2","setting":"A Phase IIa, Open-label, Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Venetoclax Plus Decitabine in Patients With AML Who Are Ineligible for Intensive Induction Therapy","sponsor":"Bio-Path Holdings, Inc.","started":"2016-05","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04684147","kind":"trial","name":"Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia","aka":[],"tldr":"A phase 2 trial of single dose of CNCT19 in acute lymphoblastic leukaemia, run by Juventas Cell Therapy Ltd., now recruiting.","summary":"Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia is a phase 2 interventional study registered as NCT04684147 by Juventas Cell Therapy Ltd., with 100 participants planned, started 2020-12-24 and due to reach its primary completion in 2022-09-22. Interventions recorded: single dose of CNCT19.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04684147","url":"https://clinicaltrials.gov/study/NCT04684147"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":["car-t"],"targets":["cd19"],"drugs":["inaticabtagene-autoleucel"],"companies":["juventas-cell-therapy"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04684147","phase":"2","setting":"Phase Ⅱ Clinical Trial of CNCT19 Cell Injection in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia","sponsor":"Juventas Cell Therapy Ltd.","started":"2020-12-24","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07656376","kind":"trial","name":"Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation","aka":[],"tldr":"A phase 2/3 trial in pancreatic cancer, run by Jiangxi Kvvit Pharmaceutical Co., Ltd., not yet recruiting.","summary":"Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation is a phase 2/3, randomised interventional study registered as NCT07656376 by Jiangxi Kvvit Pharmaceutical Co., Ltd., with a registry enrolment figure of 465 participants, started 2027-06-06 and due to reach its primary completion in 2029-02-07. Interventions recorded: DN022150+AG( Stage I ）; DN022150+AG（Stage II）; placebo+AG（Stage II）. Conditions listed: Pancreatic Cancer; Pancreatic Carcinoma. Primary outcome: DLT; PFS as assessed by BICR per RECIST 1.1; OS. Pancreatic eligibility wording from the registry: \"Subjects with confirmed KRAS G12D who have not received prior systemic antineoplastic therapy for advanced or metastatic pancreatic cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07656376","url":"https://clinicaltrials.gov/study/NCT07656376"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07656376","phase":"2/3","setting":"Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation","sponsor":"Jiangxi Kvvit Pharmaceutical Co., Ltd.","started":"2027-06-06","startedType":"estimated","enrolled":465,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06781567","kind":"trial","name":"Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma","aka":[],"tldr":"A phase 2 trial of HG146 in salivary gland cancers and head and neck squamous cell carcinoma, run by HitGen Inc., now recruiting.","summary":"Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma is a phase 2 interventional study registered as NCT06781567 by HitGen Inc., with 140 participants planned, started 2024-12-13 and due to reach its primary completion in 2028-12-31. Interventions recorded: HG146.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06781567","url":"https://clinicaltrials.gov/study/NCT06781567"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["salivary-gland","head-and-neck","adenoid-cystic-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06781567","phase":"2","setting":"A Phase Il Clinical Study to Evaluate the Efficacy and Safety of HG146 Capsules in Participants with Recurrent or Metastatic Adenoid Cystic Carcinoma.","sponsor":"HitGen Inc.","started":"2024-12-13","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06745908","kind":"trial","name":"Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In","aka":[],"tldr":"A phase 3 trial of Nogapendekin alfa inbakicept, Tislelizumab and Docetaxel in non-small-cell lung cancer, run by ImmunityBio, Inc., now recruiting.","summary":"Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In is a phase 3 interventional study registered as NCT06745908 by ImmunityBio, Inc., with 507 participants planned, started 2025-10-01 and due to reach its primary completion in 2028-09. Interventions recorded: N-803, Tislelizumab, Docetaxel and Prior failed checkpoint inhibitor.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06745908","url":"https://clinicaltrials.gov/study/NCT06745908"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytokine-therapy","cytotoxic-chemotherapy"],"targets":[],"drugs":["nogapendekin-alfa","tislelizumab","docetaxel"],"companies":["immunitybio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06745908","phase":"3","setting":"Randomized, Two-Cohort, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy","sponsor":"ImmunityBio, Inc.","started":"2025-10-01","startedType":"actual","enrolled":507,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07176182","kind":"trial","name":"Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression is a phase 2, randomised interventional study registered as NCT07176182 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 236 participants, started 2026-03-20 and due to reach its primary completion in 2031-03-20. Interventions recorded: mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment group; mFOLFOX regimen neoadjuvant therapy group. Conditions listed: Rectal Cancer Patients; Rectal Cancer Stage II; Rectal Cancer Stage III. Primary outcome: Tumor downstaging rate (to ypTNM stage 0-I). Colorectal eligibility wording from the registry: \"Histopathologically confirmed rectal adenocarcinoma; all other histologic subtypes are excluded\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07176182","url":"https://clinicaltrials.gov/study/NCT07176182"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07176182","phase":"2","setting":"mFOLFOX6 Combined With Citrus Flavonoid Tablets (Aimailang) as Neoadjuvant Therapy for Locally Advanced Rectal Cancer With High YWHAB Expression: A Prospective, Multi-center, Open-Label, Randomized Controlled Phase II Clinical Trial","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2026-03-20","startedType":"actual","enrolled":236,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06194656","kind":"trial","name":"Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma","aka":[],"tldr":"A phase 2 trial of Cetuximab in head and neck squamous cell carcinoma, run by Shanghai Institute Of Biological Products, now recruiting.","summary":"Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma is a phase 2 interventional study registered as NCT06194656 by Shanghai Institute Of Biological Products, with 81 participants planned, started 2024-09-27 and due to reach its primary completion in 2026-07-30. Interventions recorded: HER3 Monoclonal antibodies-Dose A, HER3 Monoclonal antibodies-Dose B, HER3 Monoclonal antibodies-Dose C, HER3 Monoclonal antibodies-Dose D, Placebo. Conditions listed: Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06194656","url":"https://clinicaltrials.gov/study/NCT06194656"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06194656","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of SIBP-03 Injection Combined With Cetuximab in Patients With Recurrent/Metastatic Advanced Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma)","sponsor":"Shanghai Institute Of Biological Products","started":"2024-09-27","startedType":"actual","enrolled":81,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06400160","kind":"trial","name":"Clinical Trial of TB511 in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of pembrolizumab in colorectal cancer, run by Twinpig Biolab, Inc., not yet recruiting.","summary":"Clinical Trial of TB511 in Advanced Solid Tumors is a phase 1/2, interventional study registered as NCT06400160 by Twinpig Biolab, Inc., with a registry enrolment figure of 12 participants, started 2026-03 and due to reach its primary completion in 2027-03. Interventions recorded: TB511; Keytruda. Conditions listed: NSCLC; Prostate Cancer; Colorectal Cancer; Hepatocellular Carcinoma. Primary outcome: Phase I Clinical trial-Maximum tolerated dose (MTD).; Phase I Clinical trial-Recommended Phase IIa dose (RP2D).; Phase IIa Clinical trial-anti-tumor effect-to evaluate the Objective response rate (ORR) of TB511 monotherapy and combination therapy with Pembrolizumab in patients with advanced solid tu. Colorectal eligibility wording from the registry: \"* Documented irreversible surgical sterilization by hysterectomy, dual ovariectomy, or oophorectomy (tubal litigation does not satisfy this criteria)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06400160","url":"https://clinicaltrials.gov/study/NCT06400160"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06400160","phase":"1/2","setting":"An Open-label, Multi-center, and Dose-escalation, Phase 1/2a Clinical Trial to Assess the Maximum Tolerated Dose(MTD), Safety, and the Anti-tumor Effect of TB511 Monotherapy in Patients With Advanced Solid Tumors Refractory or Intolerant to Standard of Care(SoC) and Pembrolizumab Combination Therapy in Patients With Advanced Solid Tumors Relapsed or Refractory","sponsor":"Twinpig Biolab, Inc.","started":"2026-03","startedType":"estimated","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07008976","kind":"trial","name":"Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer","aka":[],"tldr":"A phase 3 trial testing TQB2102 in HR-positive / HER2-negative breast cancer and HER2-positive breast cancer, now recruiting.","summary":"Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer is a phase 3 interventional study registered as NCT07008976, led by Chia Tai Tianqing Pharmaceutical Nanjing Shunxin Pharmaceutical, and recruiting on the registry. Official title: A Randomised, Open-label, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in Patients With HER2-positive Advanced Breast Cancer. Planned enrolment is 246 participants (estimated). The study started in 2025-07-07 and primary completion is expected in 2028-03. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07008976","url":"https://clinicaltrials.gov/study/NCT07008976"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb2102"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07008976","phase":"3","setting":"A Randomized, Open-label, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in Patients With HER2-positive Advanced Breast Cancer","sponsor":"Chia Tai Tianqing Pharmaceutical Nanjing Shunxin Pharmaceutical","started":"2025-07-07","startedType":"actual","enrolled":246,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06829771","kind":"trial","name":"Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma","aka":[],"tldr":"A phase 1/2 trial of TQB2825 in diffuse large b-cell lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., now recruiting.","summary":"Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma is a phase 1/2 interventional study registered as NCT06829771 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with 90 participants planned, started 2025-04-23 and due to reach its primary completion in 2026-05. Interventions recorded: TQB2825 injection +R-CHOP regimen, TQB2825 injection + GemOx. Conditions listed: Diffuse Large B Cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06829771","url":"https://clinicaltrials.gov/study/NCT06829771"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb2825"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06829771","phase":"1/2","setting":"Phase Ib/II Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2025-04-23","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06854445","kind":"trial","name":"Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Diffuse Large B-cell Lymphoma","aka":[],"tldr":"A phase 2 trial of Gemcitabine, Oxaliplatin and TQB2825 in non-Hodgkin lymphoma, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd., now recruiting.","summary":"Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Diffuse Large B-cell Lymphoma is a phase 2 interventional study registered as NCT06854445 by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd., with 55 participants planned, started 2025-03-12 and due to reach its primary completion in 2025-10. Interventions recorded: TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06854445","url":"https://clinicaltrials.gov/study/NCT06854445"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["gemcitabine","oxaliplatin","tqb2825"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06854445","phase":"2","setting":"Phase II Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma","sponsor":"Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.","started":"2025-03-12","startedType":"actual","enrolled":55,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07299747","kind":"trial","name":"Clinical Trial of VBC103 in Patients With Advanced Malignant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of VBC103 in advanced solid tumours, run by VelaVigo Bio Inc, now recruiting.","summary":"Clinical Trial of VBC103 in Patients With Advanced Malignant Solid Tumors is a phase 1/2 interventional study registered as NCT07299747 by VelaVigo Bio Inc, with 255 participants planned, started 2025-12-04 and due to reach its primary completion in 2027-12-01. Interventions recorded: VBC103.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07299747","url":"https://clinicaltrials.gov/study/NCT07299747"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":["trop2","nectin4"],"drugs":[],"companies":["velavigo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07299747","phase":"1/2","setting":"A Phase I/IIa Clinical Study Evaluating the Bispecific Antibody-Drug Conjugate VBC103 Targeting Nectin-4 and TROP2 in Subjects With Advanced Malignant Solid Tumors","sponsor":"VelaVigo Bio Inc","started":"2025-12-04","startedType":"actual","enrolled":255,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06975410","kind":"trial","name":"Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of YH32364 in advanced solid tumours, run by Yuhan Corporation, now recruiting.","summary":"Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors is a phase 1/2 interventional study registered as NCT06975410 by Yuhan Corporation, with 80 participants planned, started 2025-06-12 and due to reach its primary completion in 2027-06. Interventions recorded: YH32364.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06975410","url":"https://clinicaltrials.gov/study/NCT06975410"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["egfr"],"drugs":[],"companies":["yuhan"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06975410","phase":"1/2","setting":"A Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32364 in Patients With Locally Advanced or Metastatic Solid Tumors","sponsor":"Yuhan Corporation","started":"2025-06-12","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05523947","kind":"trial","name":"Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor","aka":[],"tldr":"A phase 1/2 trial of YH32367 in advanced solid tumours, run by Yuhan Corporation, now recruiting.","summary":"Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor is a phase 1/2 interventional study registered as NCT05523947 by Yuhan Corporation, with 147 participants planned, started 2022-08-26 and due to reach its primary completion in 2028-03-31. Interventions recorded: YH32367.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05523947","url":"https://clinicaltrials.gov/study/NCT05523947"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["her2"],"drugs":[],"companies":["yuhan"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05523947","phase":"1/2","setting":"A Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32367 in Patients With HER2-Positive Locally Advanced or Metastatic Solid Tumors","sponsor":"Yuhan Corporation","started":"2022-08-26","startedType":"actual","enrolled":147,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06422936","kind":"trial","name":"Clinical Trial to Evaluate BO-112 in Patients With Basal Cell Carcinoma (BCC)","aka":["SPOTLIGHT 204"],"tldr":"A phase 2 trial of BO-112 in basal cell carcinoma, run by Highlight Therapeutics, active and no longer recruiting.","summary":"Clinical Trial to Evaluate BO-112 in Patients With Basal Cell Carcinoma (BCC) is a phase 2 interventional study registered as NCT06422936 by Highlight Therapeutics, with 60 participants enrolled, started 2024-05-27 and due to reach its primary completion in 2026-06. Interventions recorded: BO-112.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06422936","url":"https://clinicaltrials.gov/study/NCT06422936"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["basal-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06422936","phase":"2","setting":"SPOTLIGHT 204: A Multicenter, Phase 2b, Open-label, Non-randomized, Clinical Trial to Evaluate Safety, Tolerability and Preliminary Efficacy of Intra-lesional BO-112 in Patients With Resectable Primary Low and High Risk Basal Cell Carcinoma","sponsor":"Highlight Therapeutics","started":"2024-05-27","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03850574","kind":"trial","name":"Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia","aka":["TUSCANY"],"tldr":"A phase 1/2 trial of Venetoclax and Azacitidine in myelodysplastic syndromes / neoplasms and chronic myelomonocytic leukaemia and MDS/MPN overlap neoplasms, run by Aptose Biosciences Inc., now recruiting.","summary":"Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia is a phase 1/2 interventional study registered as NCT03850574 by Aptose Biosciences Inc., with 240 participants planned, started 2019-03-11 and due to reach its primary completion in 2026-11. Interventions recorded: Tuspetinib, Venetoclax Oral Tablet and Azacitidine for Intravenous Infusion.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03850574","url":"https://clinicaltrials.gov/study/NCT03850574"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mds","cmml"],"sections":[],"technologies":[],"targets":[],"drugs":["venetoclax","azacitidine","tuspetinib"],"companies":["aptose"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03850574","phase":"1/2","setting":"A Phase 1/2 Open Label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM43239 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)","sponsor":"Aptose Biosciences Inc.","started":"2019-03-11","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03915184","kind":"trial","name":"Clinical Trial to Evaluate Zevor-cel (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)","aka":[],"tldr":"A phase 1/2 trial of Zevorcabtagene autoleucel in multiple myeloma, run by CARsgen Therapeutics Co., Ltd., active and no longer recruiting.","summary":"Clinical Trial to Evaluate Zevor-cel (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2) is a phase 1/2 interventional study registered as NCT03915184 by CARsgen Therapeutics Co., Ltd., with 105 participants planned, started 2019-09-25 and due to reach its primary completion in 2024-12-31. Interventions recorded: zevor-cel. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03915184","url":"https://clinicaltrials.gov/study/NCT03915184"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["zevorcabtagene-autoleucel"],"companies":["carsgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03915184","phase":"1/2","setting":"Open Label, Multi-center, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR BCMA T Cells (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)","sponsor":"CARsgen Therapeutics Co., Ltd.","started":"2019-09-25","startedType":"actual","enrolled":105,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06293651","kind":"trial","name":"Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by Dong-A ST Co., Ltd., now recruiting.","summary":"Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06293651 by Dong-A ST Co., Ltd., with 125 participants planned, started 2024-04-18 and due to reach its primary completion in 2026-01. Interventions recorded: DA-4505 and DA-4505 + Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06293651","url":"https://clinicaltrials.gov/study/NCT06293651"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["dong-a-st"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06293651","phase":"1/2","setting":"an Open-Label, Phase 1/2a, First-in-Human Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors","sponsor":"Dong-A ST Co., Ltd.","started":"2024-04-18","startedType":"actual","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07548177","kind":"trial","name":"Clinical Trials of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma","aka":[],"tldr":"A phase 2 trial of Anlotinib in sarcomas, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., now recruiting.","summary":"Clinical Trials of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma is a phase 2 interventional study registered as NCT07548177 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with 33 participants planned, started 2026-04-02 and due to reach its primary completion in 2027-11. Interventions recorded: Benmelstobart injection combined with Anlotinib hydrochloride capsule.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07548177","url":"https://clinicaltrials.gov/study/NCT07548177"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma","alveolar-soft-part-sarcoma"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["anlotinib","benmelstobart"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07548177","phase":"2","setting":"To Evaluate the Single-arm, Multi-center Phase II Clinical Trial of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2026-04-02","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"cll12","kind":"trial","name":"CLL12","aka":["GCLLSG CLL12"],"tldr":"CLL12 asked whether starting the pill ibrutinib early, before chronic lymphocytic leukaemia causes symptoms, is better than the usual practice of watching and waiting; early treatment delayed the disease but after nearly six years of follow-up people lived just as long either way, so watch and wait remains the standard.","summary":"CLL12 was the German CLL Study Group's randomised, double-blind, placebo-controlled phase 3 trial that reassessed the watch-and-wait consensus in the era of targeted drugs. 363 patients with asymptomatic Binet stage A chronic lymphocytic leukaemia at increased risk of progression (by a validated score) were randomised to ibrutinib 420 mg daily or placebo; a further 152 low-risk patients were followed without treatment. The primary endpoint was event-free survival.\n\nIbrutinib significantly delayed progression to symptomatic disease, but at a median observation of 69.3 months overall survival was the same: five-year survival 93.3 percent with ibrutinib, 93.6 percent with placebo and 97.9 percent in the watch-and-wait cohort. Cardiovascular toxicity was more common with ibrutinib. The authors conclude that watch and wait remains the standard of care for early-stage disease whatever the risk profile, and that is how the corpus's chronic lymphocytic leukaemia page cites the trial.","status":"mixed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02863718","url":"https://clinicaltrials.gov/study/NCT02863718"}],"tags":["soc-trials"],"related":[],"cancers":["cll","cll-treatment-naive","leukaemia"],"sections":[],"technologies":["kinase-inhibitors","active-surveillance"],"targets":[],"drugs":["ibrutinib"],"companies":["johnson-johnson","german-cll-study-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-cll12-ibrutinib-early-stage-langerbeins-jco-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02863718","phase":"3","setting":"Asymptomatic, untreated Binet stage A chronic lymphocytic leukaemia at increased risk of early progression: ibrutinib 420 mg daily or placebo (double-blind), with a low-risk cohort followed on watch and wait","sponsor":"German CLL Study Group","result":"Ibrutinib delayed progression to symptomatic disease but did not improve survival: five-year overall survival 93.3 percent against 93.6 percent with placebo; watch and wait remains standard for early-stage disease.","started":"2014-04-30","startedType":"actual","yearReported":2024,"enrolled":515,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Ibrutinib 420 mg daily","n":182,"value":93.3,"note":"95% CI 89.3 to 97.3; median observation 69.3 months"},{"name":"Placebo","n":181,"value":93.6,"note":"95% CI 89.5 to 97.7"},{"name":"Watch and wait (low-risk cohort, not randomised)","n":152,"value":97.9,"note":"95% CI 95.6 to 100"}],"source":"https://doi.org/10.1200/jco.24.00975"},{"endpoint":"Estimated overall survival at 10 years from diagnosis","unit":"%","arms":[{"name":"Ibrutinib 420 mg daily","value":89.8},{"name":"Placebo","value":86.5},{"name":"Watch and wait (low-risk cohort, not randomised)","value":95.3}],"source":"https://doi.org/10.1200/jco.24.00975"},{"endpoint":"Serious adverse events","unit":"%","arms":[{"name":"Ibrutinib 420 mg daily","value":60,"note":"Reported for both treatment groups together; more cardiovascular toxicity with ibrutinib"},{"name":"Placebo","value":60}],"source":"https://doi.org/10.1200/jco.24.00975"}]},{"id":"cll13-gaia","kind":"trial","name":"CLL13 / GAIA","aka":[],"tldr":"In fit patients, one year of venetoclax plus obinutuzumab (with or without ibrutinib) clearly beat the old chemotherapy standard.","summary":"Co-primary endpoints: uMRD at month 15 (GIV 92.2%, GV 86.5%, RV 57.0%, CIT 52.0%) and PFS (GIV and GV superior to CIT; RV not). 5-year PFS: GIV 81.3%, GV 69.8%, RV 57.4%, CIT 50.7%; 5-year OS 91-95% in all arms. NEJM 2023; 5-year update 2025-26. Showed that venetoclax needs obinutuzumab rather than rituximab, and that adding ibrutinib improves PFS at the cost of more toxicity.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02950051","url":"https://clinicaltrials.gov/study/NCT02950051"}],"tags":[],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":["bcl2","cd20","btk"],"drugs":["venetoclax","obinutuzumab","rituximab","ibrutinib"],"companies":["german-cll-study-group"],"institutions":[],"pathways":[],"terms":["ighv-status","mrd-negative-cr"],"trials":[],"people":["barbara-eichhorst","michael-hallek"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02950051","phase":"3","setting":"Fit, previously untreated CLL without del(17p)/TP53: chemoimmunotherapy (FCR/BR) vs venetoclax-rituximab vs venetoclax-obinutuzumab vs venetoclax-obinutuzumab-ibrutinib","sponsor":"German CLL Study Group","result":"5-year PFS 81.3% (GIV), 69.8% (GV), 57.4% (RV), 50.7% (CIT).","started":"2016-12-13","startedType":"actual","yearReported":2023,"enrolled":926,"enrolledBasis":"registry","outcomes":[{"endpoint":"Undetectable MRD at month 15 (blood)","primary":true,"unit":"%","arms":[{"name":"GIV","value":92.2},{"name":"GV","value":86.5},{"name":"RV","value":57},{"name":"Chemoimmunotherapy","value":52}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2213093"},{"endpoint":"Progression-free survival at 5 years","unit":"%","arms":[{"name":"GIV","value":81.3},{"name":"GV","value":69.8},{"name":"RV","value":57.4},{"name":"Chemoimmunotherapy","value":50.7}],"source":"https://doi.org/10.1056/NEJMoa2213093"}],"replication":"Consistent with CLL14 (unfit) and with AMPLIFY (acalabrutinib-venetoclax ± obinutuzumab), which also showed the triplet with obinutuzumab gives the highest PFS."},{"id":"cll14","kind":"trial","name":"CLL14","aka":[],"tldr":"One year of two targeted drugs, then nothing: more than half of patients were still progression-free six years later, off all treatment.","summary":"Median PFS 76.2 vs 36.4 months (HR 0.40); 6-year PFS 53.1% vs 21.7%; time to next treatment 65.2% vs 37.1% at 6 years; uMRD at end of treatment 75.5% vs 35.2%; OS difference not statistically significant. NEJM 2019; Blood 2024 (6-year). Established fixed-duration therapy as a CLL standard and uMRD as a predictor of durable remission.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02242942","url":"https://clinicaltrials.gov/study/NCT02242942"}],"tags":[],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":["bcl2","cd20"],"drugs":["venetoclax","obinutuzumab"],"companies":["german-cll-study-group"],"institutions":[],"pathways":[],"terms":["mrd-negative-cr","tumor-lysis-syndrome"],"trials":[],"people":["kirsten-fischer","michael-hallek"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02242942","phase":"3","setting":"Previously untreated CLL with coexisting conditions: 12 months of venetoclax + obinutuzumab vs chlorambucil + obinutuzumab","sponsor":"German CLL Study Group / Roche / AbbVie","result":"6-year PFS 53.1% vs 21.7%; HR 0.40.","started":"2014-12-31","startedType":"actual","yearReported":2019,"enrolled":445,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Venetoclax + obinutuzumab","n":216,"value":76.2},{"name":"Chlorambucil + obinutuzumab","n":216,"value":36.4}],"hr":0.4,"p":"<0.0001","source":"https://ashpublications.org/blood/article/144/18/1924/516941/Venetoclax-obinutuzumab-for-previously-untreated"},{"endpoint":"Progression-free survival at 6 years","unit":"%","arms":[{"name":"Venetoclax + obinutuzumab","value":53.1},{"name":"Chlorambucil + obinutuzumab","value":21.7}],"source":"https://doi.org/10.1056/NEJMoa1815281"},{"endpoint":"Undetectable MRD in blood at end of treatment","unit":"%","arms":[{"name":"Venetoclax + obinutuzumab","value":75.5},{"name":"Chlorambucil + obinutuzumab","value":35.2}],"source":"https://doi.org/10.1056/NEJMoa1815281"}],"replication":"CLL13/GAIA (fit patients) reproduced venetoclax-obinutuzumab superiority over chemoimmunotherapy; real-world registries confirm ~2-year PFS >85%."},{"id":"clocc","kind":"trial","name":"CLOCC","aka":["EORTC 40004"],"tldr":"The only randomised trial to show that burning out liver metastases, rather than just giving chemotherapy, lets more people survive eight years.","summary":"CLOCC randomised 119 patients with unresectable colorectal liver metastases to systemic treatment plus radiofrequency ablation (with resection where possible) or to systemic treatment alone. The trial closed early for slow accrual and was reported as a randomised phase 2 study. At a median follow-up of 9.7 years, 39 of 60 patients in the combined modality group had died against 53 of 59 in the systemic group; overall survival favoured local treatment (hazard ratio 0.58, 95% CI 0.38 to 0.88, p=0.01). Eight-year overall survival was 35.9 against 8.9 percent, and median overall survival 45.6 against 40.5 months. Small and underpowered, CLOCC is nonetheless the only randomised evidence that ablation of liver metastases lengthens life, and it underpins the aggressive local treatment of oligometastatic colorectal cancer.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00043004","url":"https://clinicaltrials.gov/study/NCT00043004"},{"label":"CLOCC: local treatment of unresectable colorectal liver metastases, randomised phase 2 trial (Journal of the National Cancer Institute 2017)","url":"https://doi.org/10.1093/jnci/djx015"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["thermal-ablation","microwave-rf-ablation","cytotoxic-chemotherapy"],"targets":[],"drugs":["folfox","bevacizumab","oxaliplatin"],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["radiofrequency-ablation","oligometastatic","hepatectomy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00043004","phase":"2","setting":"Unresectable colorectal liver metastases: systemic chemotherapy with radiofrequency ablation and optional resection, against systemic chemotherapy alone","sponsor":"European Organisation for Research and Treatment of Cancer","result":"Eight-year overall survival 35.9 against 8.9 percent with ablation added (hazard ratio 0.58).","started":"2002-05","yearReported":2017,"enrolled":119,"enrolledBasis":"randomised","enrolledNote":"119 patients were randomised before the trial was closed early for slow accrual; the registry status is terminated.","outcomes":[{"endpoint":"Overall survival at 8 years","primary":true,"unit":"percent","arms":[{"name":"Chemotherapy plus radiofrequency ablation","n":60,"value":35.9},{"name":"Chemotherapy alone","n":59,"value":8.9}],"hr":0.58,"ci":[0.38,0.88],"p":"0.01","source":"https://doi.org/10.1093/jnci/djx015"}]},{"id":"nct00703820","kind":"trial","name":"Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia","aka":[],"tldr":"A phase 3 trial of Cytarabine, Daunorubicin, Etoposide and Clofarabine in Acute myeloid leukaemia, run by St. Jude Children's Research Hospital, completed.","summary":"Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia is a phase 3 interventional study registered as NCT00703820 by St. Jude Children's Research Hospital, with 324 participants recorded, started 2008-08-04 and reaching its primary completion in 2017-03-30. Interventions recorded: Cytarabine, Daunorubicin, Etoposide, Clofarabine, CliniMACS. Conditions recorded: Acute Myeloid Leukemia.\n\nLinked to the drug Clofarabine because the registry names it among its interventions and Acute myeloid leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00703820","url":"https://clinicaltrials.gov/study/NCT00703820"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":["cytarabine","daunorubicin","etoposide","clofarabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00703820","phase":"3","setting":"AML08: A Phase II Randomized Trial of Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Phase II Study Of Natural Killer Cell Transplantation In Patients With Newly Diagnosed Acute Myeloid Leukemia","sponsor":"St. Jude Children's Research Hospital","started":"2008-08-04","startedType":"actual","enrolled":324,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06699836","kind":"trial","name":"CLOVER - CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen","aka":["CLOVER"],"tldr":"A phase 2 trial of Pembrolizumab in colorectal cancer, run by CytoDyn, Inc., active and no longer recruiting.","summary":"CLOVER - CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen is a phase 2 interventional study registered as NCT06699836 by CytoDyn, Inc., with 66 participants enrolled, started 2025-06-16 and due to reach its primary completion in 2028-01. Interventions recorded: 350 mg leronlimab, 700 mg leronlimab, 200 mg pembrolizumab. Conditions listed: Metastatic Colorectal Cancer (mCRC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06699836","url":"https://clinicaltrials.gov/study/NCT06699836"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06699836","phase":"2","setting":"A Phase Two Study Evaluating Two Doses of Leronlimab (PRO 140) In Combination With Trifluridine + Tipiracil (TAS-102) + Bevacizumab in Participants With Microsatellite Stable (MSS), Relapsed Refractory Metastatic Colorectal Cancer (mCRC)","sponsor":"CytoDyn, Inc.","started":"2025-06-16","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"cobrim","kind":"trial","name":"coBRIM","aka":[],"tldr":"coBRIM showed that adding cobimetinib to vemurafenib gives people with BRAF-mutant melanoma about five more months before the disease grows and about five more months of life.","summary":"coBRIM randomised 495 patients with untreated BRAF V600 metastatic melanoma to vemurafenib with cobimetinib or vemurafenib with placebo. It was the second phase 3 trial of a BRAF plus MEK doublet and used the first approved BRAF inhibitor as its backbone.\n\nMedian progression-free survival was 12.3 months with the combination against 7.2 months (hazard ratio 0.58) in the updated analysis (Lancet Oncology 2016), and median overall survival 22.3 months against 17.4 months (hazard ratio 0.70). Serous retinopathy, raised creatine kinase and photosensitivity were the notable toxicities; secondary skin cancers were less frequent than with vemurafenib alone.\n\nThe result led to approval of cobimetinib in late 2015 and, with COMBI-d and COMBI-v, settled that the doublet rather than a single BRAF inhibitor is the standard. The vemurafenib-cobimetinib backbone was later used in IMspire150 to test the addition of atezolizumab.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01689519","url":"https://clinicaltrials.gov/study/NCT01689519"},{"label":"NEJM 2014","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1408868"},{"label":"Updated analysis, Lancet Oncology 2016","url":"https://doi.org/10.1016/S1470-2045(16)30122-X"}],"tags":[],"related":[],"cancers":["braf-v600-melanoma","advanced-melanoma","melanoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["braf","mek"],"drugs":["vemurafenib","cobimetinib"],"companies":["roche-genentech"],"institutions":[],"pathways":["ras-mapk"],"terms":[],"trials":[],"people":["james-larkin","paolo-ascierto"],"bottlenecks":[],"keyPapers":["paper-cobrim-n-engl-j-med-2014","paper-cobrim-lancet-oncol-2016-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01689519","phase":"3","setting":"Untreated unresectable or metastatic BRAF V600-mutant melanoma: vemurafenib plus cobimetinib versus vemurafenib plus placebo","sponsor":"Genentech / Roche","result":"Median progression-free survival 12.3 vs 7.2 months (HR 0.58); median overall survival 22.3 vs 17.4 months (HR 0.70).","started":"2013-01-08","startedType":"actual","yearReported":2014,"enrolled":495,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Vemurafenib + cobimetinib","n":247,"value":12.3},{"name":"Vemurafenib + placebo","n":248,"value":7.2}],"hr":0.58,"source":"https://doi.org/10.1016/S1470-2045(16)30122-X"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Vemurafenib + cobimetinib","n":247,"value":22.3},{"name":"Vemurafenib + placebo","n":248,"value":17.4}],"hr":0.7,"source":"https://doi.org/10.1016/S1470-2045(16)30122-X"}],"replication":"COMBI-d and COMBI-v (dabrafenib-trametinib) and COLUMBUS (encorafenib-binimetinib) found the same class effect."},{"id":"codebreak-100","kind":"trial","name":"CodeBreaK 100 (pancreatic cancer cohort)","aka":["CodeBreaK100","CodeBreak 100","AMG 510 phase 1/2"],"tldr":"CodeBreaK 100 gave the first KRAS inhibitor to 38 people whose pancreatic cancer carried the rare G12C mutation and had progressed after chemotherapy; one in five tumours shrank and patients lived a median 6.9 months, proof that KRAS can be drugged in this disease even though the target is uncommon here.","summary":"The pooled phase 1 and 2 pancreatic cohort of CodeBreaK 100 treated 38 patients, all metastatic and previously treated (median two prior lines, range one to eight). Eight had a centrally confirmed objective response (21 percent, 95 percent confidence interval 10 to 37); median progression-free survival was 4.0 months (2.8 to 5.6) and median overall survival 6.9 months (5.0 to 9.1). Treatment-related adverse events occurred in 16 patients (42 percent), grade 3 in six (16 percent), with no fatal events or discontinuations. Sotorasib has no pancreatic indication from the FDA (label: KRAS G12C lung cancer and, with panitumumab, colorectal cancer) or the EMA, and NICE's TA781 covers lung cancer only; NCCN lists sotorasib and adagrasib (KRYSTAL-1: 7 of 21 responses) as options for KRAS G12C pancreatic cancer after first-line therapy, and daraxonrasib, which covers G12C among all RAS G12 mutations, is now approved in the United States for previously treated metastatic disease regardless of subtype.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03600883","url":"https://clinicaltrials.gov/study/NCT03600883"},{"label":"Strickler et al., sotorasib in KRAS p.G12C-mutated advanced pancreatic cancer (NEJM 2023)","url":"https://doi.org/10.1056/NEJMoa2208470"},{"label":"Lumakras label (openFDA): indications, no pancreatic cancer indication","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22LUMAKRAS%22"}],"tags":[],"related":[],"cancers":["pancreatic","kras-g12c-pdac","metastatic-pdac"],"sections":[],"technologies":["kras-inhibitors"],"targets":["kras"],"drugs":["sotorasib"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":["kras-mutation-subtypes"],"trials":["nct03785249","rasolute-302"],"people":["john-strickler"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03600883","phase":"1/2","setting":"Previously treated metastatic KRAS G12C-mutated pancreatic cancer (about 1 to 2 percent of pancreatic tumours), single group: sotorasib 960 mg once daily, with centrally confirmed objective response as the phase 2 primary endpoint","sponsor":"Amgen","result":"Objective response 21 percent (8 of 38; 95 percent confidence interval 10 to 37); median progression-free survival 4.0 months; median overall survival 6.9 months; grade 3 treatment-related adverse events 16 percent.","started":"2018-08-27","startedType":"actual","yearReported":2023,"enrolled":38,"enrolledBasis":"treated","enrolledNote":"ClinicalTrials.gov NCT03600883 lists 713 participants across every tumour cohort of CodeBreaK 100; 38 is the pooled phase 1 and 2 pancreatic cancer cohort treated in the NEJM 2023 report.","outcomes":[{"endpoint":"Objective response (central review)","primary":true,"unit":"%","arms":[{"name":"Sotorasib 960 mg daily","n":38,"value":21,"note":"8 of 38; 95% CI 10 to 37"}],"source":"https://doi.org/10.1056/NEJMoa2208470"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Sotorasib 960 mg daily","n":38,"value":6.9,"note":"95% CI 5.0 to 9.1"}],"source":"https://doi.org/10.1056/NEJMoa2208470"}]},{"id":"codebreak-200","kind":"trial","name":"CodeBreaK 200","aka":[],"tldr":"The first randomised trial of a KRAS drug: better than chemotherapy on progression, not on survival.","summary":"CodeBreaK 200, trial NCT04303780 sponsored by Amgen and reported in 2022, was the first randomised trial of a KRAS drug, comparing sotorasib with docetaxel in previously treated KRAS G12C-mutant non-small-cell lung cancer. It randomised 345 patients, met its primary progression-free survival endpoint by blinded review and showed a higher response rate, but overall survival was no different, a result confounded by crossover and dropout, and an FDA advisory committee questioned the benefit in 2023 so that full approval was not granted on this trial alone. OnCo links it to KRAS as a target, to Ferdinandos Skoulidis and to the bottleneck of undruggable drivers, and its findings are consistent with KRYSTAL-12 for adagrasib. Whether a progression benefit without a survival benefit justifies a new standard is the question the trial forced the field to confront. Sotorasib has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT04303780","url":"https://clinicaltrials.gov/study/NCT04303780"}],"tags":[],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":["kras-inhibitors"],"targets":["kras"],"drugs":["sotorasib"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ferdinandos-skoulidis"],"bottlenecks":[],"keyPapers":["paper-codebreak-200-lancet-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04303780","phase":"3","setting":"Previously treated KRAS G12C NSCLC: sotorasib vs docetaxel","sponsor":"Amgen","result":"PFS HR 0.66; OS HR 1.01.","started":"2020-06-04","startedType":"actual","yearReported":2022,"enrolled":345,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Sotorasib","n":171,"value":5.6},{"name":"Docetaxel","n":174,"value":4.5}],"hr":0.66,"ci":[0.51,0.86],"p":"0.0017","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00221-0/fulltext"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Sotorasib","value":10.6,"note":"Not significant; crossover permitted"},{"name":"Docetaxel","value":11.3}],"hr":1.01,"source":"https://doi.org/10.1016/S0140-6736(23)00221-0"}],"replication":"Consistent with KRYSTAL-12 (adagrasib) on PFS; the FDA declined full approval at the 960 mg dose pending further data."},{"id":"codebreak-300","kind":"trial","name":"CodeBreaK 300","aka":[],"tldr":"CodeBreaK 300 showed that a KRAS drug needs an EGFR antibody partner to work in colorectal cancer.","summary":"CodeBreaK 300, trial NCT05198934 sponsored by Amgen and published in the New England Journal of Medicine in 2023, showed that a KRAS G12C inhibitor needs an EGFR antibody partner to work in colorectal cancer. It randomised 160 patients with previously treated KRAS G12C colorectal cancer to sotorasib at two doses with panitumumab or standard trifluridine-tipiracil or regorafenib, met its primary progression-free survival endpoint for the 960 mg dose with responses in about a quarter against none, and led to approval in January 2025. OnCo links it to colorectal cancer, KRAS and EGFR as targets, sotorasib, panitumumab, the pairing of a KRAS G12C inhibitor with an anti-EGFR antibody and the CodeBreaK 200 and 300 papers. Whether the combination can move into first-line treatment is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05198934","url":"https://clinicaltrials.gov/study/NCT05198934"}],"tags":[],"related":[],"cancers":["colorectal","kras-g12c-colorectal"],"sections":[],"technologies":["kras-inhibitors"],"targets":["kras","egfr"],"drugs":["sotorasib"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06252649"],"people":[],"bottlenecks":[],"keyPapers":["paper-codebreak-300-nejm-2023","paper-schirripa-kras-g12c-metastatic-colorectal-clin-colorectal-cancer-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05198934","phase":"3","setting":"KRAS G12C colorectal cancer, previously treated: sotorasib + panitumumab vs standard of care","sponsor":"Amgen","result":"PFS HR 0.49.","started":"2022-04-19","startedType":"actual","yearReported":2023,"enrolled":160,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR), sotorasib 960 mg + panitumumab","primary":true,"unit":"months","arms":[{"name":"Sotorasib 960 mg + panitumumab","n":53,"value":5.6},{"name":"Trifluridine-tipiracil or regorafenib","n":54,"value":2.2}],"hr":0.49,"ci":[0.3,0.8],"p":"0.006","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2308795"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Sotorasib 960 mg + panitumumab","value":26.4},{"name":"Trifluridine-tipiracil or regorafenib","value":0}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2308795"}],"replication":"Consistent with KRYSTAL-1 (adagrasib + cetuximab, ORR 34%), so the KRAS G12C + anti-EGFR combination is supported by two independent programmes."},{"id":"codel","kind":"trial","name":"CODEL","aka":[],"tldr":"CODEL is the intergroup trial meant to settle whether oligodendroglioma patients should get temozolomide or the older three-drug PCV combination with their radiotherapy; its first phase already showed that temozolomide on its own, without radiotherapy, lets the tumour come back sooner.","summary":"CODEL (Alliance N0577) opened in 2009 for newly diagnosed anaplastic glioma with 1p/19q codeletion, randomising to radiotherapy alone, radiotherapy with concurrent and adjuvant temozolomide, or temozolomide alone. After RTOG 9402 and EORTC 26951 showed that adding PCV chemotherapy to radiotherapy doubled survival in codeleted tumours, the radiotherapy-alone arm was closed and the trial was redesigned to compare radiotherapy with temozolomide against radiotherapy with PCV, and widened to grade 2 tumours.\n\nThe analysis of the original arms, published in 2021, found that patients treated with temozolomide alone had significantly shorter progression-free survival than those who received radiotherapy, which removed deferred radiotherapy from routine practice. The main comparison of temozolomide against PCV with radiotherapy is still accruing and following patients.","status":"active","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00887146","url":"https://clinicaltrials.gov/study/NCT00887146"}],"tags":["subtype-trials"],"related":["paper-eortc-26951-van-den-bent-jco-2013"],"cancers":["oligodendroglioma","glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide","procarbazine","lomustine","vincristine"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00887146","phase":"3","setting":"Newly diagnosed 1p/19q-codeleted glioma: originally radiotherapy with temozolomide against radiotherapy alone or temozolomide alone; redesigned as radiotherapy with temozolomide against radiotherapy with PCV chemotherapy","sponsor":"Alliance for Clinical Trials in Oncology","result":"Temozolomide alone gave shorter progression-free survival than radiotherapy-containing treatment in 1p/19q-codeleted glioma; the redesigned comparison of radiotherapy with temozolomide against radiotherapy with PCV is ongoing.","started":"2009-09","startedType":"actual","yearReported":2021,"enrolled":305,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05692024","kind":"trial","name":"COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER","aka":["COMMENCER"],"tldr":"A phase 1/2 trial in colorectal cancer, run by Massachusetts General Hospital, now recruiting.","summary":"COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER is a phase 1/2, randomised interventional study registered as NCT05692024 by Massachusetts General Hospital, with a registry enrolment figure of 80 participants, started 2024-03-21 and due to reach its primary completion in 2028-03-31. Interventions recorded: Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule.; Placebo. Conditions listed: Colorectal Cancer; Coffee; Gastrointestinal Microbiome; Stenosis; Fibrosis, Liver; Ultrasound Elastography; Proton Magnetic Resonance Spectroscopy. Primary outcome: Change in hepatic fat fraction.. Colorectal eligibility wording from the registry: \"* Participants must have histologically confirmed stage I, II, or III colon or rectal adenocarcinoma and have completed standard treatment (including surgery, chemotherapy and radiotherapy) at least 2 months ago\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05692024","url":"https://clinicaltrials.gov/study/NCT05692024"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05692024","phase":"1/2","setting":"COMMENCER: COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER","sponsor":"Massachusetts General Hospital","started":"2024-03-21","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"aall0434","kind":"trial","name":"COG AALL0434","aka":["AALL0434"],"tldr":"AALL0434 was the largest trial ever run in childhood T-cell leukaemia; it showed that adding the drug nelarabine to standard chemotherapy cut relapses, and that most children could be cured without radiation to the brain.","summary":"The Children's Oncology Group trial AALL0434 enrolled 1895 patients aged 1 to 30 with newly diagnosed T-cell acute lymphoblastic leukaemia or T-lymphoblastic lymphoma. Intermediate- and high-risk patients were randomised in a two-by-two design to augmented Berlin-Frankfurt-Munster chemotherapy with or without six courses of nelarabine, and to Capizzi escalating-dose methotrexate with pegaspargase or to high-dose methotrexate.\n\nNelarabine improved disease-free survival in T-cell leukaemia, with fewer central nervous system relapses, and the Capizzi methotrexate arm outperformed high-dose methotrexate. Cranial irradiation was omitted for all but the highest-risk group without excess central nervous system relapse. Overall survival across the trial was the best yet reported for T-cell leukaemia, and nelarabine became part of front-line therapy for higher-risk disease.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00408005","url":"https://clinicaltrials.gov/study/NCT00408005"}],"tags":["subtype-trials"],"related":[],"cancers":["all-paediatric-high-risk","all-leukemia"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["nelarabine","methotrexate"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["kimberly-dunsmore"],"bottlenecks":[],"keyPapers":["paper-aall0434-nelarabine-t-all-dunsmore-jco-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00408005","phase":"3","setting":"Newly diagnosed T-cell acute lymphoblastic leukaemia and lymphoblastic lymphoma in children and young adults: augmented BFM chemotherapy with or without nelarabine, and Capizzi-style escalating methotrexate against high-dose methotrexate","sponsor":"Children's Oncology Group (National Cancer Institute)","result":"Nelarabine improved disease-free survival in T-cell acute lymphoblastic leukaemia, and Capizzi methotrexate outperformed high-dose methotrexate.","started":"2007-01-30","startedType":"actual","yearReported":2020,"enrolled":1895,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 5 years (nelarabine randomisation)","unit":"%","arms":[{"name":"Nelarabine","n":323,"value":88.2},{"name":"No nelarabine","n":336,"value":82.1}],"p":"0.029","source":"https://doi.org/10.1200/JCO.20.00256"},{"endpoint":"Isolated or combined CNS relapse","unit":"%","arms":[{"name":"Nelarabine","value":1.3},{"name":"No nelarabine","value":6.9}],"p":"0.0001","source":"https://doi.org/10.1200/JCO.20.00256"},{"endpoint":"Event-free survival at 5 years, all patients","unit":"%","arms":[{"name":"All patients","n":1562,"value":83.7}],"source":"https://doi.org/10.1200/JCO.20.00256"},{"endpoint":"Overall survival at 5 years, all patients","unit":"%","arms":[{"name":"All patients","n":1562,"value":89.5}],"source":"https://doi.org/10.1200/JCO.20.00256"}]},{"id":"aall1731","kind":"trial","name":"COG AALL1731","aka":[],"tldr":"In children with average-risk leukaemia, adding blinatumomab pushed three-year disease-free survival from 88% to 96%, one of the largest gains in decades.","summary":"1,440 randomised children with standard-risk average or high subsets. 3-year DFS 96.0% vs 87.9% (HR 0.39, 95% CI 0.24-0.64); randomisation stopped early for efficacy. NEJM 2024. Led to FDA approval of blinatumomab in the consolidation phase for CD19+ Ph-negative B-ALL in children (June 2024) and is being adopted as the new paediatric standard.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03914625","url":"https://clinicaltrials.gov/study/NCT03914625"},{"label":"NEJM 2024","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2411680"}],"tags":[],"related":[],"cancers":["all-leukemia","all-paediatric-standard-risk"],"sections":[],"technologies":["t-cell-engager"],"targets":["cd19","cd3"],"drugs":["blinatumomab","crisantaspase"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["stephen-hunger","sumit-gupta","rachel-rau"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03914625","phase":"3","setting":"Newly diagnosed standard-risk B-ALL in children: two cycles of blinatumomab added to chemotherapy vs chemotherapy alone","sponsor":"Children's Oncology Group / NCI","result":"3-year DFS 96.0% vs 87.9%; HR 0.39.","started":"2019-07-03","startedType":"actual","yearReported":2024,"enrolled":1440,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists an estimated 6,720 participants for the whole trial, which enrols all standard-risk patients; the NEJM 2024 interim analysis covered the 1,440 patients randomised (722 chemotherapy, 718 blinatumomab) before randomisation was stopped.","outcomes":[{"endpoint":"Disease-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Blinatumomab + chemotherapy","n":722,"value":96},{"name":"Chemotherapy","n":718,"value":87.9}],"hr":0.39,"ci":[0.24,0.64],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2411680"}],"replication":"Consistent with E1910 in adults; the paediatric MRD-positive blinatumomab trials (AALL1331, IntReALL HR 2010) had shown benefit in relapse earlier."},{"id":"aaml0531","kind":"trial","name":"COG AAML0531","aka":[],"tldr":"Adding the antibody-drug conjugate gemtuzumab ozogamicin to chemotherapy lowered the chance of relapse in children with acute myeloid leukaemia. Years after the drug had been withdrawn from the US market, this trial helped bring it back for children.","summary":"Randomised phase 3 (Gamis et al., JCO 2014), 1,022 evaluable patients. Gemtuzumab ozogamicin (GO, 3 mg/m2) given once in induction course 1 and once in intensification course 2 improved 3-year event-free survival (53.1% versus 46.9%; HR 0.83; 95% CI 0.70 to 0.99) through a reduction in relapse risk, with a non-significant trend in overall survival and slightly higher post-remission treatment-related mortality. Benefit was later shown to track with CD33 expression and CD33 splicing genotype, an early example of a pharmacogenomic biomarker in paediatric oncology. GO had been withdrawn in the US in 2010 after the adult SWOG S0106 trial; AAML0531 together with the adult ALFA-0701 trial supported the 2017 FDA re-approval, which included children. Successor COG trials (AAML1031, AAML1831) build on this backbone with FLT3 inhibitors and CPX-351.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT00372593","url":"https://clinicaltrials.gov/study/NCT00372593"},{"label":"Gamis et al., JCO 2014","url":"https://doi.org/10.1200/JCO.2014.55.3628"}],"tags":["nci-coverage","paediatric","haematologic"],"related":[],"cancers":["aml","aml-paediatric"],"sections":[],"technologies":["adc"],"targets":["cd33"],"drugs":["gemtuzumab-ozogamicin","cytarabine-7-3"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":["alfa-0701"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00372593","phase":"3","setting":"Newly diagnosed AML, age 0-29: standard five-course chemotherapy with or without two doses of gemtuzumab ozogamicin","sponsor":"Children's Oncology Group","result":"3-year EFS 53.1% vs 46.9%, HR 0.83; relapse risk reduced.","started":"2006-08","yearReported":2014,"enrolled":1070,"enrolledBasis":"registry","outcomes":[{"endpoint":"3-year event-free survival","primary":true,"unit":"%","arms":[{"name":"Chemotherapy + gemtuzumab ozogamicin","value":53.1},{"name":"Chemotherapy","value":46.9}],"hr":0.83,"ci":[0.7,0.99],"source":"https://doi.org/10.1200/JCO.2014.55.3628"}],"replication":"Adult ALFA-0701 (fractionated GO) and the MRC AML15/16 meta-analysis showed the same relapse reduction; the CD33 splicing biomarker was confirmed in AAML0531 and AAML1031 correlative studies."},{"id":"acns0331","kind":"trial","name":"COG ACNS0331","aka":[],"tldr":"This trial asked whether children with average-risk medulloblastoma could safely receive less radiation. Shrinking the boost to the tumour bed was safe; cutting the dose to the whole brain and spine in young children was not, so 23.4 Gy remains the floor for most.","summary":"Randomised phase 3 (Michalski et al., JCO 2021). 549 enrolled; 464 evaluable for the boost-volume comparison and 226 for the CSI-dose comparison. Five-year event-free survival was 82.5% with involved-field boost versus 80.5% with posterior fossa boost (HR 0.97; non-inferior), and 71.4% with 18 Gy CSI versus 82.9% with 23.4 Gy (HR 1.67; inferior). Post hoc molecular subgrouping showed the dose reduction harmed group 4 tumours most, while SHH tumours did better with involved-field boost. The trial set the current average-risk standard (23.4 Gy CSI plus tumour-bed boost to 54 Gy) and showed that further de-escalation must be subgroup-directed, which the successor trials (ACNS1422 for WNT, SIOP PNET5) now test.","status":"mixed","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT00085735","url":"https://clinicaltrials.gov/study/NCT00085735"},{"label":"Michalski et al., JCO 2021","url":"https://doi.org/10.1200/JCO.20.02730"}],"tags":["nci-coverage","paediatric","cns","de-escalation"],"related":[],"cancers":["medulloblastoma","medulloblastoma-wnt","medulloblastoma-group-3-4"],"sections":[],"technologies":["proton-therapy","imrt-igrt"],"targets":[],"drugs":["cisplatin","vincristine","cyclophosphamide","lomustine"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":["late-effects","de-escalation"],"trials":[],"people":[],"bottlenecks":["b-survivorship","b-toxicity-qol"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00085735","phase":"3","setting":"Average-risk medulloblastoma, age 3-21: involved-field (tumour bed) vs whole posterior fossa boost; and, in children aged 3-7, 18 Gy vs 23.4 Gy craniospinal irradiation","sponsor":"Children's Oncology Group","result":"Involved-field boost non-inferior (5-year EFS 82.5% vs 80.5%); 18 Gy CSI inferior to 23.4 Gy (71.4% vs 82.9%).","started":"2004-04-30","startedType":"actual","yearReported":2021,"enrolled":549,"enrolledBasis":"registry","outcomes":[{"endpoint":"5-year event-free survival: boost volume","primary":true,"unit":"%","arms":[{"name":"Involved-field boost","value":82.5},{"name":"Posterior fossa boost","value":80.5}],"hr":0.97,"source":"https://doi.org/10.1200/JCO.20.02730"},{"endpoint":"5-year event-free survival: CSI dose (age 3-7)","primary":true,"unit":"%","arms":[{"name":"18 Gy CSI","value":71.4},{"name":"23.4 Gy CSI","value":82.9}],"hr":1.67,"source":"https://doi.org/10.1200/JCO.20.02730"}],"replication":"Consistent with the earlier CCG 9892 and A9961 experience that 23.4 Gy with chemotherapy is safe for average risk; SIOP PNET5 is testing subgroup-directed reduction."},{"id":"acns0332","kind":"trial","name":"COG ACNS0332","aka":["ACNS0332"],"tldr":"ACNS0332 found that giving carboplatin alongside radiotherapy improved survival for children with the most aggressive group 3 medulloblastomas, while isotretinoin, tested in the same trial, did nothing and was dropped.","summary":"ACNS0332 randomised children and young adults with high-risk medulloblastoma (metastatic, incompletely resected or with anaplasia) to 36 Gy craniospinal radiotherapy plus weekly vincristine with or without daily carboplatin as a radiosensitiser, followed by maintenance chemotherapy with or without isotretinoin. The isotretinoin randomisation closed early for futility.\n\nCarboplatin during radiotherapy did not improve event-free survival in the whole cohort, but in the molecularly defined group 3 subgroup it improved event-free and overall survival, a finding that came from the trial's tumour profiling. The result made carboplatin radiosensitisation a standard for group 3 high-risk disease and was one of the first paediatric brain tumour trials to show benefit in a molecular subgroup.","status":"mixed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00392327","url":"https://clinicaltrials.gov/study/NCT00392327"}],"tags":["subtype-trials"],"related":[],"cancers":["medulloblastoma-group-3-4","medulloblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","vincristine","cisplatin","cyclophosphamide","isotretinoin"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sarah-leary"],"bottlenecks":[],"keyPapers":["paper-acns0332-leary-jama-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00392327","phase":"3","setting":"Newly diagnosed high-risk medulloblastoma in children aged 3 to 21: craniospinal radiotherapy with weekly vincristine, with or without daily carboplatin, and with or without isotretinoin maintenance","sponsor":"Children's Oncology Group","result":"Carboplatin radiosensitisation improved event-free and overall survival in group 3 high-risk medulloblastoma; isotretinoin maintenance was stopped for futility.","started":"2007-05-23","startedType":"actual","yearReported":2021,"enrolled":379,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Carboplatin with craniospinal radiotherapy","value":66.4},{"name":"No carboplatin","value":59.2}],"p":"0.11","source":"https://doi.org/10.1001/jamaoncol.2021.2224"},{"endpoint":"Event-free survival at 5 years, group 3 medulloblastoma","unit":"%","arms":[{"name":"Carboplatin with craniospinal radiotherapy","value":73.2},{"name":"No carboplatin","value":53.7}],"p":"0.047","source":"https://doi.org/10.1001/jamaoncol.2021.2224"},{"endpoint":"Overall survival at 5 years, all evaluable participants","unit":"%","arms":[{"name":"All evaluable participants","n":261,"value":73.4,"note":"Isotretinoin randomisation closed early for futility"}],"source":"https://doi.org/10.1001/jamaoncol.2021.2224"}]},{"id":"anbl0032","kind":"trial","name":"COG ANBL0032","aka":[],"tldr":"The trial that made anti-GD2 immunotherapy standard for children with high-risk neuroblastoma, improving survival by about 20 points.","summary":"COG ANBL0032, trial NCT00026312 run by the Children's Oncology Group and published in the New England Journal of Medicine in 2010, made anti-GD2 immunotherapy standard for children with high-risk neuroblastoma, improving survival by about twenty points. It randomised 226 children after transplant to the anti-GD2 antibody ch14.18, now dinutuximab, with GM-CSF, interleukin-2 and isotretinoin, or isotretinoin alone, met its primary event-free survival endpoint at two years and improved overall survival, was stopped early for efficacy, and led to approval in 2015 with long-term follow-up confirming the gain. OnCo links it to paediatric neuroblastoma, GD2 as a target, dinutuximab, the Children's Oncology Group, Alice L. Yu, Julie R. Park and the bottleneck of paediatric cancers without markets. Whether anti-GD2 can move earlier into induction is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00026312","url":"https://clinicaltrials.gov/study/NCT00026312"}],"tags":[],"related":[],"cancers":["neuroblastoma","neuroblastoma-high-risk"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["gd2"],"drugs":["dinutuximab","isotretinoin"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["alice-yu","julie-park"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00026312","phase":"3","setting":"High-risk neuroblastoma after transplant: ch14.18 (dinutuximab) + GM-CSF + IL-2 + isotretinoin vs isotretinoin alone","sponsor":"Children's Oncology Group","result":"2-year EFS 66% vs 46%; OS 86% vs 75%.","started":"2001-10-26","startedType":"actual","yearReported":2010,"enrolled":226,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 1,449 participants (actual) enrolled over the life of the study; the NEJM 2010 analysis randomised 226 eligible patients.","outcomes":[{"endpoint":"Event-free survival at 2 years","primary":true,"unit":"%","arms":[{"name":"Immunotherapy + isotretinoin","n":113,"value":66},{"name":"Isotretinoin","n":113,"value":46}],"p":"0.01","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa0911123"},{"endpoint":"Overall survival at 2 years","unit":"%","arms":[{"name":"Immunotherapy + isotretinoin","value":86},{"name":"Isotretinoin","value":75}],"p":"0.02","source":"https://doi.org/10.1056/NEJMoa0911123"}],"replication":"SIOPEN HR-NBL1 confirmed anti-GD2 benefit with dinutuximab beta (and showed IL-2 adds no efficacy)."},{"id":"anbl0532","kind":"trial","name":"COG ANBL0532","aka":[],"tldr":"COG ANBL0532 showed that two transplants in a row beat one in high-risk neuroblastoma.","summary":"COG ANBL0532, trial NCT00567567 run by the Children's Oncology Group and published in JAMA in 2019, showed that two autologous transplants in a row beat one in high-risk neuroblastoma. It randomised 652 children after induction to tandem or single transplant and met its primary event-free survival endpoint at three years, with a larger gap when followed by anti-GD2 immunotherapy, while overall survival was not significantly different at three years. OnCo links it to paediatric neuroblastoma, tandem autologous transplant, autologous stem cell transplant, the Children's Oncology Group and Julie R. Park. Tandem transplant became the North American standard, and whether the added toxicity is justified without a survival benefit, especially where European groups use a single transplant, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00567567","url":"https://clinicaltrials.gov/study/NCT00567567"}],"tags":[],"related":[],"cancers":["neuroblastoma","neuroblastoma-high-risk"],"sections":[],"technologies":["tandem-transplant","autologous-stem-cell-transplant"],"targets":[],"drugs":[],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["julie-park"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00567567","phase":"3","setting":"High-risk neuroblastoma: tandem vs single autologous transplant after induction","sponsor":"Children's Oncology Group","result":"3-year EFS 61.6% vs 48.4%.","started":"2007-11-05","startedType":"actual","yearReported":2016,"enrolled":665,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Tandem transplant","n":176,"value":61.6},{"name":"Single transplant","n":179,"value":48.4}],"p":"0.006","source":"https://jamanetwork.com/journals/jama/fullarticle/2751686"}]},{"id":"anbl1531","kind":"trial","name":"COG ANBL1531","aka":[],"tldr":"COG ANBL1531 is the current North American high-risk trial, adding targeted radiation during induction and an ALK pill for children whose tumours carry ALK mutations.","summary":"COG ANBL1531, trial NCT03126916 run by the Children's Oncology Group, is the current North American trial for newly diagnosed high-risk neuroblastoma, adding iodine-131 MIBG targeted radiation during induction in a randomised comparison for MIBG-avid tumours and the ALK inhibitor lorlatinib in a non-randomised arm for children whose tumours carry ALK aberrations. It also tests reduced-intensity therapy in the standard arm and tracks uptake of eflornithine maintenance, with the primary MIBG randomisation results expected in 2026 to 2027 and encouraging response rates reported from the lorlatinib arm. OnCo links it to paediatric neuroblastoma, MIBG imaging and therapy, ALK as a target, 131I-MIBG therapy, lorlatinib, the Children's Oncology Group and Yael P. Mossé. Whether targeted radiation during induction improves cure rates is the question it will answer.","status":"active","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03126916","url":"https://clinicaltrials.gov/study/NCT03126916"}],"tags":[],"related":[],"cancers":["neuroblastoma","neuroblastoma-high-risk"],"sections":[],"technologies":["mibg-theranostics"],"targets":["alk"],"drugs":["i131-mibg","lorlatinib"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["yael-mosse"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03126916","phase":"3","setting":"Newly diagnosed high-risk neuroblastoma: 131I-MIBG added to induction (randomised, MIBG-avid); lorlatinib added for ALK-aberrant tumours (non-randomised arm)","sponsor":"Children's Oncology Group","started":"2018-05-14","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"aren0532","kind":"trial","name":"COG AREN0532","aka":["AREN0532"],"tldr":"AREN0532 tested treating the lowest-risk Wilms tumours with surgery alone and no chemotherapy, and giving more treatment only to children whose tumours carried particular chromosome losses; both ideas worked and now guide how much therapy each child gets.","summary":"AREN0532 was the Children's Oncology Group's risk-stratified trial for favourable-histology Wilms tumour, enrolling 808 children. Those under two years with small stage I tumours (very low risk) had nephrectomy alone and were watched; the standard-risk groups received vincristine and dactinomycin, with doxorubicin and radiotherapy added by stage, and those whose tumours showed loss of heterozygosity at both 1p and 16q, a marker of relapse identified in NWTS-5, were moved to more intensive regimens.\n\nSurgery alone gave excellent survival in the very low-risk group, with the few relapses salvaged, and augmenting therapy for the 1p/16q loss group improved event-free survival compared with historical controls. The trial embedded molecular risk markers in Wilms tumour treatment for the first time.","status":"completed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00352534","url":"https://clinicaltrials.gov/study/NCT00352534"}],"tags":["subtype-trials"],"related":[],"cancers":["wilms-tumor","childhood-cancers"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["vincristine","dactinomycin","doxorubicin"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00352534","phase":"3","setting":"Very low-risk and standard-risk favourable-histology Wilms tumour: nephrectomy alone with observation for very low-risk disease, and risk-adapted vincristine, dactinomycin and doxorubicin with or without radiotherapy for the rest, with treatment intensified for tumours with loss of heterozygosity at 1p and 16q","sponsor":"Children's Oncology Group","result":"Nephrectomy alone was adequate for very low-risk favourable-histology Wilms tumour, and intensified therapy improved outcomes for tumours with 1p and 16q loss of heterozygosity.","started":"2006-11-06","startedType":"actual","yearReported":2018,"enrolled":808,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 4 years by risk group (registry results)","primary":true,"unit":"%","arms":[{"name":"Very low risk (surgery alone)","value":88,"note":"95% CI 79 to 98"},{"name":"Standard risk, stage I or II with loss of heterozygosity at 1p and 16q","value":87,"note":"95% CI 73 to 100"},{"name":"Standard risk, stage III","value":88,"note":"95% CI 85 to 91"}],"source":"https://clinicaltrials.gov/study/NCT00352534?tab=results"},{"endpoint":"Overall survival at 4 years by risk group (registry results)","primary":true,"unit":"%","arms":[{"name":"Very low risk (surgery alone)","value":100},{"name":"Standard risk, stage I or II with loss of heterozygosity at 1p and 16q","value":100},{"name":"Standard risk, stage III","value":97,"note":"95% CI 95 to 99"}],"source":"https://clinicaltrials.gov/study/NCT00352534?tab=results"}]},{"id":"aren0533","kind":"trial","name":"COG AREN0533","aka":[],"tldr":"A risk-adapted Wilms tumour trial: children whose lung metastases vanished after six weeks of chemotherapy were spared lung radiation, while those with stubborn nodules or a high-risk chromosome pattern got stronger chemotherapy and did better than in the past.","summary":"Single-arm, biology- and response-adapted phase 3 (Dix et al., JCO 2018 and 2019). Among 292 assessable patients with lung metastases, 133 had complete lung nodule response after six weeks of vincristine, dactinomycin and doxorubicin (DD4A) and continued without lung radiotherapy: 4-year EFS 79.5% with excellent overall survival, though events exceeded expectation. The 159 with incomplete response, or LOH at 1p/16q, received lung radiotherapy plus four cycles of cyclophosphamide and etoposide (Regimen M): 4-year EFS 88.5%, better than the 75% target. Overall 4-year EFS and OS were 85.4% and 95.6% versus 72.5% and 84.0% in the predecessor NWTS-5. Companion analysis of patients with 1p/16q LOH showed 4-year EFS of 87.3% (stage I-II, AREN0532) and 90.2% (stage III-IV, AREN0533), improved from 68.8% and 61.3% in NWTS-5. Together with AREN0532, it made molecular and response-based risk stratification the North American Wilms standard, mirroring the SIOP approach in Europe.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT00379340","url":"https://clinicaltrials.gov/study/NCT00379340"},{"label":"Dix et al., JCO 2018 (lung metastases)","url":"https://doi.org/10.1200/JCO.2017.77.1931"},{"label":"Dix et al., JCO 2019 (LOH 1p/16q)","url":"https://doi.org/10.1200/JCO.18.01972"}],"tags":["nci-coverage","paediatric","kidney"],"related":[],"cancers":["wilms-tumor"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["vincristine","dactinomycin","doxorubicin","cyclophosphamide","etoposide"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":["de-escalation","late-effects"],"trials":[],"people":[],"bottlenecks":["b-survivorship"],"keyPapers":["paper-dix-j-clin-oncol","paper-dix-j-clin-oncol-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00379340","phase":"3","setting":"Stage III-IV favourable-histology Wilms tumour: response-based omission of lung radiotherapy after complete lung nodule response; augmented chemotherapy (Regimen M) for incomplete response or 1p/16q loss of heterozygosity","sponsor":"Children's Oncology Group","result":"Overall 4-year EFS 85.4% and OS 95.6% (vs 72.5% and 84.0% in NWTS-5); 4-year EFS 90.2% for LOH 1p/16q stage III-IV with augmented therapy.","started":"2007-04-30","startedType":"actual","yearReported":2018,"enrolled":395,"enrolledBasis":"registry","outcomes":[{"endpoint":"4-year event-free survival (all lung-metastasis patients)","primary":true,"unit":"%","arms":[{"name":"AREN0533 risk-adapted","n":292,"value":85.4},{"name":"NWTS-5 (historical)","value":72.5}],"p":"<0.001","source":"https://doi.org/10.1200/JCO.2017.77.1931"},{"endpoint":"4-year event-free survival, LOH 1p/16q stage III-IV, Regimen M","unit":"%","arms":[{"name":"AREN0533 Regimen M","n":51,"value":90.2},{"name":"NWTS-5 (historical)","value":61.3}],"source":"https://doi.org/10.1200/JCO.18.01972"}],"replication":"Non-randomised against historical NWTS-5 controls; the SIOP-RTSG UMBRELLA protocol in Europe pursues the same response- and biology-adapted logic."},{"id":"nct01091974","kind":"trial","name":"Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy","aka":[],"tldr":"A phase 2 trial of Cognitive behavioural therapy for insomnia in Breast cancer, run by University of Rochester, completed.","summary":"Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy is a phase 2 interventional study registered as NCT01091974 by University of Rochester, with 138 participants recorded, started 2008-02 and reaching its primary completion in 2013-04. Interventions recorded: armodafinil, Placebo Comparator, CBT-I. Conditions recorded: Insomnia, Fatigue, Breast Cancer.\n\nLinked to the technology Cognitive behavioural therapy for insomnia because the registry names it (\"cbt i\") among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01091974","url":"https://clinicaltrials.gov/study/NCT01091974"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["cbt-insomnia-cancer"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01091974","phase":"2","setting":"Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy","sponsor":"University of Rochester","started":"2008-02","yearReported":2015,"enrolled":138,"enrolledBasis":"registry","outcomes":[{"endpoint":"Change in Insomnia Severity Index From Baseline to Post-intervention","primary":true,"unit":"units on a scale","arms":[{"name":"Arm 1 - (CBT-I) + Placebo","n":24,"value":-4.93,"note":"SE 1.85; Figures from the ClinicalTrials.gov results section (first posted 2015-03-13), not from a publication"},{"name":"2 - CBT-I + Armodafinil","n":23,"value":-6.36,"note":"SE 1.84"},{"name":"3- Placebo Only","n":25,"value":1.04,"note":"SE 1.89"},{"name":"4 - Armodafinil Only","n":24,"value":-1.43,"note":"SE 1.78"}],"source":"https://clinicaltrials.gov/study/NCT01091974?tab=results"}]},{"id":"nct06185556","kind":"trial","name":"COLDFIRE-III Trial: Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases","aka":["COLDFIRE-III"],"tldr":"A phase 2/3 trial in colorectal cancer, run by Amsterdam UMC, location VUmc, now recruiting.","summary":"COLDFIRE-III Trial: Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases is a phase 2/3, randomised interventional study registered as NCT06185556 by Amsterdam UMC, location VUmc, with a registry enrolment figure of 78 participants, started 2024-08-20 and due to reach its primary completion in 2029-09-01. Interventions recorded: Irreversible electroporation; Stereotactic body radiotherapy. Conditions listed: Colorectal Cancer; Liver Metastases; Liver Metastasis Colon Cancer; Unresectable Solid Tumor. Primary outcome: Local control. Colorectal eligibility wording from the registry: \"* Histological documentation of primary colorectal tumor is available;\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06185556","url":"https://clinicaltrials.gov/study/NCT06185556"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":["angiodynamics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06185556","phase":"2/3","setting":"COLDFIRE-III Trial: Perivascular and Peribiliary Colorectal Liver Metastases (0-5cm): Irreversible Electroporation Versus Stereotactic Body Radiotherapy","sponsor":"Amsterdam UMC, location VUmc","started":"2024-08-20","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05861505","kind":"trial","name":"COLLISION RELAPSE Trial","aka":["COLLISION RELAPSE"],"tldr":"A phase 3 trial in colorectal cancer, run by Amsterdam UMC, location VUmc, now recruiting.","summary":"COLLISION RELAPSE Trial is a phase 3, randomised interventional study registered as NCT05861505 by Amsterdam UMC, location VUmc, with a registry enrolment figure of 360 participants, started 2023-04-24 and due to reach its primary completion in 2027-05-01. Interventions recorded: Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B); Repeat local treatment. Conditions listed: Colorectal Cancer; Liver Metastases; Liver Metastasis Colon Cancer; Chemotherapy Effect; Surgery; Recurrence. Primary outcome: Overall survival (OS) per patient. Colorectal eligibility wording from the registry: \"* Histological documentation of primary colorectal tumor\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05861505","url":"https://clinicaltrials.gov/study/NCT05861505"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05861505","phase":"3","setting":"COLLISION RELAPSE Trial - Recurrent Colorectal Liver Metastases: Repeat Local Treatment +/- Neoadjuvant Systemic Therapy - a Phase III Prospective Randomized Controlled Trial","sponsor":"Amsterdam UMC, location VUmc","started":"2023-04-24","startedType":"actual","enrolled":360,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07272772","kind":"trial","name":"Colon Cancer Diagnosis With FAPI-PET Imaging","aka":[],"tldr":"A phase 2/3 trial in colorectal cancer, run by Turku University Hospital, now recruiting.","summary":"Colon Cancer Diagnosis With FAPI-PET Imaging is a phase 2/3, interventional study registered as NCT07272772 by Turku University Hospital, with a registry enrolment figure of 100 participants, started 2024-10-09 and due to reach its primary completion in 2026-10. Interventions recorded: PET/CT ([F-18]FAPI-74). Conditions listed: Colon Cancer. Primary outcome: 1) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of local lymph node metastasis in patient level in patients with primary colon cancer; 2) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of distant metastasis in patient level in patients wi. Colorectal eligibility wording from the registry: \"* Patients with primary colon cancer with suspicion of mesenteric lymph node metastases in computed tomography before primary cancer operation\". Sites: Finland. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07272772","url":"https://clinicaltrials.gov/study/NCT07272772"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07272772","phase":"2/3","setting":"Diagnostic Efficacy of 18F-FAPI-74 PET/CT in Patients With Colon Cancer","sponsor":"Turku University Hospital","started":"2024-10-09","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"colopec","kind":"trial","name":"COLOPEC","aka":[],"tldr":"Giving the heated abdominal wash as insurance, before any peritoneal disease has appeared, did not prevent it.","summary":"COLOPEC randomised 204 patients with clinical or pathological T4 or perforated colon cancer at nine Dutch HIPEC centres to adjuvant oxaliplatin HIPEC (460 mg/m2 for 30 minutes at 42 degrees, simultaneously or within five to eight weeks of resection) followed by routine adjuvant chemotherapy, or to adjuvant chemotherapy alone, with diagnostic laparoscopy at 18 months in everyone free of recurrence. Peritoneal metastases were diagnosed in 19 of 100 in the HIPEC group and 23 of 102 in the control group, and peritoneal metastasis-free survival at 18 months was 80.9 against 76.2 percent (one-sided p=0.28). Twelve of 87 patients who received HIPEC had postoperative complications and one developed encapsulating peritoneal sclerosis. Adjuvant HIPEC is not recommended on this evidence.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02231086","url":"https://clinicaltrials.gov/study/NCT02231086"},{"label":"COLOPEC: adjuvant hyperthermic intraperitoneal chemotherapy in locally advanced colon cancer (Lancet Gastroenterology and Hepatology 2019)","url":"https://doi.org/10.1016/S2468-1253(19)30239-0"}],"tags":[],"related":[],"cancers":["colorectal","colon-cancer"],"sections":[],"technologies":["hipec"],"targets":[],"drugs":["oxaliplatin","capox","folfox"],"companies":[],"institutions":["amsterdam-umc"],"pathways":[],"terms":[],"trials":["prodige-7","prophylochip"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02231086","phase":"3","setting":"T4 or perforated colon cancer at high risk of peritoneal spread: adjuvant oxaliplatin HIPEC followed by systemic chemotherapy, against systemic chemotherapy alone","sponsor":"Amsterdam UMC","result":"Peritoneal metastasis-free survival at 18 months 80.9 against 76.2 percent: no benefit.","started":"2015-03","startedType":"actual","yearReported":2019,"enrolled":204,"enrolledBasis":"registry","outcomes":[{"endpoint":"Peritoneal metastasis-free survival at 18 months","primary":true,"unit":"percent","arms":[{"name":"Adjuvant HIPEC plus chemotherapy","n":100,"value":80.9},{"name":"Adjuvant chemotherapy","n":102,"value":76.2}],"p":"0.28 one-sided","source":"https://doi.org/10.1016/S2468-1253(19)30239-0"}]},{"id":"nct03919461","kind":"trial","name":"Colorectal Metastasis Prevention International Trial 2","aka":["COMPIT-2"],"tldr":"A phase 2 trial of propranolol (Hemangeol) in colorectal cancer, run by Assaf-Harofeh Medical Center, now recruiting.","summary":"Colorectal Metastasis Prevention International Trial 2 is a phase 2, randomised interventional study registered as NCT03919461 by Assaf-Harofeh Medical Center, with a registry enrolment figure of 200 participants, started 2019-02-28 and due to reach its primary completion in 2027-02-28. Interventions recorded: Propranolol and etodolac; Placebo. Conditions listed: Colorectal Neoplasms. Primary outcome: 5-year disease-free-survival; Biomarkers in extracted tumor tissue samples assessing pro- and anti-metastatic processes; Biomarkers in blood samples assessing pro- and anti-metastatic processes. Colorectal eligibility wording from the registry: \"Patients planned for surgery for primary resection of colon or rectal cancer with curative intent\". Sites: Israel. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03919461","url":"https://clinicaltrials.gov/study/NCT03919461"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["propranolol-hemangeol"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03919461","phase":"2","setting":"Perioperative Use of a β-adrenergic Blocker, Propranolol, and a COX2 Inhibitor, Etodolac, in Patients Undergoing Resection With Curative Intent for Primary Colon and Rectal Cancer: Effect on Tumor Recurrence and Survival","sponsor":"Assaf-Harofeh Medical Center","started":"2019-02-28","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04068610","kind":"trial","name":"COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC","aka":["COLUMBIA-1"],"tldr":"A phase 1/2 trial of Durvalumab, Oleclumab, FOLFOX in colorectal cancer, run by MedImmune LLC, active and no longer recruiting.","summary":"COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC is a phase 1/2 interventional study registered as NCT04068610 by MedImmune LLC, with 61 participants enrolled, started 2019-09-13 and due to reach its primary completion in 2022-10-10. Interventions recorded: Durvalumab, Oleclumab, FOLFOX, Bevacizumab. Conditions listed: Metastatic Microsatellite-stable Colorectal Cancer. Results were posted on ClinicalTrials.gov in 2023; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04068610","url":"https://clinicaltrials.gov/study/NCT04068610"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["durvalumab","oleclumab","folfox","bevacizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04068610-br-j-cancer-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04068610","phase":"1/2","setting":"A Phase Ib/II, Open-label, Multicenter Study of Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First-line Therapy in Metastatic Microsatellite-stable Colorectal Cancer (COLUMBIA-1)","sponsor":"MedImmune LLC","started":"2019-09-13","startedType":"actual","yearReported":2023,"enrolled":61,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in Part 2","primary":true,"unit":"%","arms":[{"name":"Part 2 (C1): FOLFOX + Bevacizumab","n":26,"value":46.2,"note":"95% CI 26.6 to 66.6; Figures from the ClinicalTrials.gov results section (first posted 2023-11-15), not from a publication"},{"name":"Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab","n":26,"value":61.5,"note":"95% CI 40.6 to 79.8"}],"p":"0.3173","source":"https://clinicaltrials.gov/study/NCT04068610?tab=results"},{"endpoint":"Overall Survival (OS) Per RECIST v1.1 in Part 1","unit":"months","arms":[{"name":"Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab","n":7,"value":30.1,"note":"95% CI 11.9 to NA; Figures from the ClinicalTrials.gov results section (first posted 2023-11-15), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04068610?tab=results"},{"endpoint":"Progression-Free Survival (PFS) Per RECIST v1.1 in Part 1","unit":"months","arms":[{"name":"Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab","n":7,"value":9.5,"note":"95% CI 7.8 to 18.2; Figures from the ClinicalTrials.gov results section (first posted 2023-11-15), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04068610?tab=results"}]},{"id":"columbus","kind":"trial","name":"COLUMBUS","aka":[],"tldr":"COLUMBUS tested encorafenib-binimetinib, the third BRAF/MEK doublet, which has the longest median survival of the class and less fever than dabrafenib-trametinib.","summary":"COLUMBUS, trial NCT01909453 sponsored by Array, now Pfizer, and reported in 2018, tested encorafenib plus binimetinib, the third BRAF and MEK doublet, in advanced BRAF V600 melanoma against vemurafenib and against encorafenib alone. It randomised 577 patients, met its primary progression-free survival endpoint against vemurafenib with a large effect, and its seven-year update showed the longest median survival of the class, with less fever and photosensitivity than dabrafenib plus trametinib, attributed to encorafenib's longer dissociation half-life on BRAF; approval followed in June 2018. OnCo links it to BRAF as a target, the MAPK pathway, encorafenib, binimetinib, vemurafenib, Paolo A. Ascierto and Reinhard Dummer, and the class effect was replicated in coBRIM and COMBI-d and COMBI-v. Whether the tolerability difference changes which doublet clinicians choose is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01909453","url":"https://clinicaltrials.gov/study/NCT01909453"},{"label":"Lancet Oncology 2018","url":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30142-6/fulltext"}],"tags":[],"related":[],"cancers":["melanoma","braf-v600-melanoma","advanced-melanoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["braf"],"drugs":["encorafenib","binimetinib","vemurafenib"],"companies":["pfizer"],"institutions":[],"pathways":["ras-mapk"],"terms":[],"trials":[],"people":["paolo-ascierto","reinhard-dummer"],"bottlenecks":[],"keyPapers":["paper-columbus-lancet-oncol-2018","paper-columbus-lancet-oncol-2018-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01909453","phase":"3","setting":"Advanced BRAF V600 melanoma: encorafenib + binimetinib vs vemurafenib vs encorafenib","sponsor":"Array / Pfizer","result":"PFS 14.9 vs 7.3 months (HR 0.54); median OS 33.6 months.","started":"2013-09-12","startedType":"actual","yearReported":2018,"enrolled":577,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Encorafenib + binimetinib","value":14.9},{"name":"Vemurafenib","value":7.3}],"hr":0.54,"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30142-6/fulltext"}],"replication":"Class effect replicated across coBRIM (vemurafenib-cobimetinib) and COMBI-d/v (dabrafenib-trametinib)."},{"id":"combi-ad","kind":"trial","name":"COMBI-AD","aka":[],"tldr":"A year of two targeted pills after surgery halves the risk of relapse in BRAF-mutant melanoma, and the benefit is still visible a decade later.","summary":"RFS HR 0.47 at first analysis; final analysis (JCO 2024, >10 years) reported 10-year RFS 48% vs 32% and DMFS 63% vs 48%. OS analysis was hampered by crossover and subsequent immunotherapy. The longest follow-up of any adjuvant melanoma trial; the alternative to adjuvant PD-1 for BRAF-mutant patients.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01682083","url":"https://clinicaltrials.gov/study/NCT01682083"},{"label":"Final analysis, ASCO 2024","url":"https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.9500"}],"tags":[],"related":[],"cancers":["melanoma","braf-v600-melanoma","stage-iii-melanoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["braf"],"drugs":["dabrafenib-trametinib"],"companies":["novartis"],"institutions":[],"pathways":["ras-mapk"],"terms":[],"trials":[],"people":["georgina-long"],"bottlenecks":[],"keyPapers":["paper-combi-ad-nejm-2017","paper-combi-ad-n-engl-j-med-2020-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01682083","phase":"3","setting":"Resected stage III BRAF V600-mutant melanoma: adjuvant dabrafenib + trametinib 1 year vs placebo","sponsor":"Novartis","result":"10-year RFS 48% vs 32%; DMFS 63% vs 48%.","started":"2013-01-08","startedType":"actual","yearReported":2017,"enrolled":870,"enrolledBasis":"registry","outcomes":[{"endpoint":"Relapse-free survival at 10 years","primary":true,"unit":"%","arms":[{"name":"Dabrafenib + trametinib","value":48},{"name":"Placebo","value":32}],"source":"https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.9500"},{"endpoint":"Distant metastasis-free survival at 10 years","unit":"%","arms":[{"name":"Dabrafenib + trametinib","value":63},{"name":"Placebo","value":48}],"source":"https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.9500"}],"replication":"No second adjuvant BRAF/MEK phase 3 (BRIM8 with vemurafenib alone was mixed); benefit consistent with metastatic COMBI-d/v data."},{"id":"combi-d","kind":"trial","name":"COMBI-d","aka":[],"tldr":"COMBI-d showed that adding a MEK inhibitor to a BRAF inhibitor delays progression and lengthens life in BRAF-mutant melanoma, and that the pairing causes fewer of the skin cancers that BRAF inhibitors alone provoke.","summary":"COMBI-d randomised 423 patients with untreated BRAF V600E or V600K metastatic melanoma to dabrafenib plus trametinib or dabrafenib plus placebo. The trial tested the idea that blocking MEK downstream of BRAF would both deepen the response and prevent the paradoxical MAPK activation in BRAF wild-type skin cells that causes squamous cell carcinomas on BRAF inhibitor monotherapy.\n\nThe primary progression-free survival endpoint was met, and in the final analysis (Lancet 2015) median progression-free survival was 11.0 months against 8.8 months and median overall survival 25.1 months against 18.7 months (hazard ratio 0.71). Cutaneous squamous cell carcinomas fell from 9 percent to 2 percent, while fever became the characteristic toxicity of the doublet. A pooled analysis of COMBI-d and COMBI-v (NEJM 2019) found 34 percent of patients alive and 19 percent progression free at five years, with the best outcomes in patients with normal lactate dehydrogenase and fewer than three disease sites.\n\nCOMBI-d, with COMBI-v against vemurafenib, made BRAF plus MEK inhibition the standard form of targeted therapy in melanoma and the template for the same pairing in lung, thyroid and brain tumours with BRAF V600 mutations.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01584648","url":"https://clinicaltrials.gov/study/NCT01584648"},{"label":"NEJM 2014","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1406037"},{"label":"Final analysis, Lancet 2015","url":"https://doi.org/10.1016/S0140-6736(15)60898-4"},{"label":"Pooled 5-year analysis, NEJM 2019","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1904059"}],"tags":[],"related":[],"cancers":["braf-v600-melanoma","advanced-melanoma","melanoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["braf","mek"],"drugs":["dabrafenib-trametinib","dabrafenib","trametinib"],"companies":["novartis","gsk"],"institutions":[],"pathways":["ras-mapk"],"terms":[],"trials":[],"people":["georgina-long","keith-flaherty"],"bottlenecks":[],"keyPapers":["paper-combi-d-n-engl-j-med-2014"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01584648","phase":"3","setting":"Untreated unresectable or metastatic BRAF V600E or V600K melanoma: dabrafenib plus trametinib versus dabrafenib plus placebo","sponsor":"GSK, then Novartis","result":"Median progression-free survival 11.0 vs 8.8 months; median overall survival 25.1 vs 18.7 months (HR 0.71); pooled COMBI-d/v 5-year overall survival 34%.","started":"2012-05-04","startedType":"actual","yearReported":2014,"enrolled":423,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Dabrafenib + trametinib","n":211,"value":11},{"name":"Dabrafenib + placebo","n":212,"value":8.8}],"hr":0.67,"source":"https://doi.org/10.1016/S0140-6736(15)60898-4"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Dabrafenib + trametinib","n":211,"value":25.1},{"name":"Dabrafenib + placebo","n":212,"value":18.7}],"hr":0.71,"source":"https://doi.org/10.1016/S0140-6736(15)60898-4"}],"replication":"COMBI-v (dabrafenib-trametinib versus vemurafenib), coBRIM (vemurafenib-cobimetinib) and COLUMBUS (encorafenib-binimetinib) all found the same class effect."},{"id":"nct00083382","kind":"trial","name":"Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide","aka":[],"tldr":"A phase 2 trial of Pamidronate, Thalidomide and Zoledronic acid in Multiple myeloma, run by University of Arkansas, completed.","summary":"Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide is a phase 2 interventional study registered as NCT00083382 by University of Arkansas, with 83 participants recorded, started 1998-12 and reaching its primary completion in 2014-05. Interventions recorded: Pamidronate, Thalidomide, Zometa. Conditions recorded: Multiple Myeloma.\n\nLinked to the drug Pamidronate because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00083382","url":"https://clinicaltrials.gov/study/NCT00083382"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","smouldering-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["pamidronate","thalidomide","zoledronic-acid"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00083382","phase":"2","setting":"UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Smoldering/Indolent Myeloma","sponsor":"University of Arkansas","started":"1998-12","enrolled":83,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00628810","kind":"trial","name":"Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer","aka":["AvastinR"],"tldr":"A phase 2 trial of UGT1A1 genotyping before irinotecan in Colorectal cancer, run by Federation Francophone de Cancerologie Digestive, completed.","summary":"Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer is a phase 2 interventional study registered as NCT00628810 by Federation Francophone de Cancerologie Digestive, with 86 participants recorded, started 2007-01 and reaching its primary completion in 2008-01. Interventions recorded: bevacizumab, fluorouracil, irinotecan hydrochloride, leucovorin calcium. Conditions recorded: Colorectal Cancer.\n\nLinked to the technology UGT1A1 genotyping before irinotecan because the registry's title names it (\"ugt1a1 28\") and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00628810","url":"https://clinicaltrials.gov/study/NCT00628810"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["ugt1a1-genotyping"],"targets":[],"drugs":["fluorouracil","irinotecan","leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00628810","phase":"2","setting":"Chemotherapy With FOLFIRI Plus Bevacizumab (AvastinR) in Patients With Metastatic Colorectal Cancer Bearing Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/UGT1A1*1/UGT1A1*28: Prospective, Phase II, Multicenter Study","sponsor":"Federation Francophone de Cancerologie Digestive","started":"2007-01","enrolled":86,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02883049","kind":"trial","name":"Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations","aka":[],"tldr":"A phase 3 trial of Clofarabine, Cyclophosphamide, Cytarabine, Dasatinib, Daunorubicin, Dexamethasone, Doxorubicin, Etoposide, Leucovorin, Mercaptopurine, Methotrexate, Asparaginase, Prednisone, Thioguanine and Vincristine in Acute lymphoblastic leukaemia and Leukaemia, run by National Cancer Institute (NCI), completed.","summary":"Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations is a phase 3 interventional study registered as NCT02883049 by National Cancer Institute (NCI), with 5949 participants recorded, started 2012-02-29 and reaching its primary completion in 2022-12-31. Interventions recorded: Clofarabine, Cyclophosphamide, Cytarabine, Dasatinib, Daunorubicin Hydrochloride, Dexamethasone, Doxorubicin Hydrochloride, Etoposide, Hydrocortisone Sodium Succinate, Laboratory Biomarker Analysis, Leucovorin Calcium, Mercaptopurine, Methotrexate, Pegaspargase, Prednisone, Radiation Therapy, Thioguanine, Vincristine Sulfate. Conditions recorded: B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, BCR-ABL1-Like, Central Nervous System Leukemia, Testicular Leukemia.\n\nLinked to the drug Clofarabine because the registry names it among its interventions and Acute lymphoblastic leukaemia and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02883049","url":"https://clinicaltrials.gov/study/NCT02883049"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","leukaemia","all-paediatric-high-risk","all-ph-like"],"sections":[],"technologies":[],"targets":[],"drugs":["clofarabine","cyclophosphamide","cytarabine","dasatinib","daunorubicin","dexamethasone","doxorubicin","etoposide","leucovorin","mercaptopurine","methotrexate","asparaginase","prednisone","thioguanine","vincristine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02883049","phase":"3","setting":"A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations","sponsor":"National Cancer Institute (NCI)","started":"2012-02-29","startedType":"actual","yearReported":2024,"enrolled":5949,"enrolledBasis":"registry","outcomes":[{"endpoint":"DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone","primary":true,"unit":"%","arms":[{"name":"Non-DS HR B-ALL Arm A","n":868,"value":92.48,"note":"95% CI 90.7 to 94.3; Figures from the ClinicalTrials.gov results section (first posted 2024-03-12), not from a publication"},{"name":"Non-DS HR B-ALL Arm B","n":866,"value":92.33,"note":"95% CI 90.5 to 94.2"}],"hr":1.022,"ci":[0.74,1.413],"p":"0.893","source":"https://clinicaltrials.gov/study/NCT02883049?tab=results"},{"endpoint":"DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1)","primary":true,"unit":"%","arms":[{"name":"Non-DS VHR B-ALL Control Arm","n":335,"value":77.11,"note":"95% CI 72.4 to 81.8; Figures from the ClinicalTrials.gov results section (first posted 2024-03-12), not from a publication"},{"name":"Non-DS VHR B-ALL Exp Arm1","n":488,"value":76.75,"note":"95% CI 72.8 to 80.7"}],"hr":1.019,"p":"0.556","source":"https://clinicaltrials.gov/study/NCT02883049?tab=results"}]},{"id":"nct00005838","kind":"trial","name":"Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery","aka":[],"tldr":"A phase 3 trial of Shark cartilage in Lung cancer and Non-small-cell lung cancer, run by National Cancer Institute (NCI), completed.","summary":"Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery is a phase 3 interventional study registered as NCT00005838 by National Cancer Institute (NCI), with 756 participants recorded, started 2000-03 and reaching its primary completion in 2007-02. Interventions recorded: shark cartilage extract AE-941, placebo, cisplatin, vinorelbine tartrate, carboplatin, paclitaxel, radiation therapy. Conditions recorded: Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Large Cell Lung Cancer, Squamous Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer.\n\nLinked to the technology Shark cartilage because the registry names it (\"shark cartilage\") among its interventions and Lung cancer and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00005838","url":"https://clinicaltrials.gov/study/NCT00005838"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["lung-cancer","nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["shark-cartilage"],"targets":[],"drugs":["cisplatin","vinorelbine","carboplatin","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00005838","phase":"3","setting":"Multicenter, Open-Ended, Double-Blind, Placebo-Controlled, Phase III Study of AE-941 in Addition to Combined Modality Treatment (Chemotherapy/Radiotherapy) for Locally Advanced Unresectable Non-Small Cell Lung Cancer","sponsor":"National Cancer Institute (NCI)","started":"2000-03","enrolled":756,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00003436","kind":"trial","name":"Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myeloid Leukemia","aka":[],"tldr":"A phase 3 trial of Amsacrine, Asparaginase, Cytarabine, Daunorubicin, Etoposide, Methotrexate and Mitoxantrone in Leukaemia and Myelodysplastic syndromes / neoplasms, run by Medical Research Council, completed.","summary":"Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myeloid Leukemia is a phase 3 interventional study registered as NCT00003436 by Medical Research Council, with 2000 participants recorded, started 1998-07. Interventions recorded: amsacrine, asparaginase, cytarabine, daunorubicin hydrochloride, etoposide, methotrexate, mitoxantrone hydrochloride, therapeutic hydrocortisone, allogeneic bone marrow transplantation. Conditions recorded: Leukemia, Myelodysplastic Syndromes.\n\nLinked to the drug Amsacrine because the registry names it among its interventions and Leukaemia and Myelodysplastic syndromes / neoplasms among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00003436","url":"https://clinicaltrials.gov/study/NCT00003436"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia","mds"],"sections":[],"technologies":[],"targets":[],"drugs":["amsacrine","asparaginase","cytarabine","daunorubicin","etoposide","methotrexate","mitoxantrone"],"companies":["mrc-ctu"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003436","phase":"3","setting":"Medical Research Council Working Party on Leukaemia in Childhood Acute Myeloid Leukaemia Trial 12","sponsor":"Medical Research Council","started":"1998-07","enrolled":2000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00002719","kind":"trial","name":"Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia","aka":[],"tldr":"A phase 3 trial of Filgrastim, Amsacrine, Carmustine, Cytarabine, Etoposide, Idarubicin and Mitoxantrone in Leukaemia, run by European Organisation for Research and Treatment of Cancer - EORTC, completed.","summary":"Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia is a phase 3 interventional study registered as NCT00002719 by European Organisation for Research and Treatment of Cancer - EORTC, with 500 participants recorded, started 1995-12 and reaching its primary completion in 2001-11. Interventions recorded: filgrastim, amsacrine, carmustine, cytarabine, etoposide, idarubicin, mitoxantrone hydrochloride, peripheral blood stem cell transplantation. Conditions recorded: Leukemia, Neutropenia.\n\nLinked to the drug Amsacrine because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00002719","url":"https://clinicaltrials.gov/study/NCT00002719"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["filgrastim","amsacrine","carmustine","cytarabine","etoposide","idarubicin","mitoxantrone"],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002719","phase":"3","setting":"RANDOMIZED PHASE III STUDY TO EVALUATE THE VALUE OF rHuG-CSF IN INDUCTION AND OF AN ORAL SCHEDULE AS CONSOLIDATION TREATMENT IN ELDERLY PATIENTS WITH ACUTE MYELOGENOUS LEUMEKIA (AML-13 PROTOCOL)","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","started":"1995-12","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00557193","kind":"trial","name":"Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia","aka":[],"tldr":"A phase 3 trial of Asparaginase, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone, Etoposide, Filgrastim, Leucovorin, Mercaptopurine, Methotrexate, Prednisone and Vincristine in Acute lymphoblastic leukaemia and Leukaemia, run by Children's Oncology Group, completed.","summary":"Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia is a phase 3 interventional study registered as NCT00557193 by Children's Oncology Group, with 218 participants recorded, started 2008-01-15 and reaching its primary completion in 2017-09-30. Interventions recorded: Asparaginase, Biospecimen Collection, Bone Marrow Biopsy, Cyclophosphamide, Cytarabine, Daunorubicin Hydrochloride, Dexamethasone, Echocardiography, Etoposide, Filgrastim, Laboratory Biomarker Analysis, Lestaurtinib, Leucovorin Calcium, Mercaptopurine, Methotrexate, Methylprednisolone, Multigated Acquisition Scan, Pegaspargase, Pharmacological Study, Prednisone, Therapeutic Hydrocortisone, Vincristine Sulfate. Conditions recorded: Acute Lymphoblastic Leukemia, Acute Undifferentiated Leukemia, Childhood T Acute Lymphoblastic Leukemia.\n\nLinked to the drug Mercaptopurine because the registry names it among its interventions and Acute lymphoblastic leukaemia and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00557193","url":"https://clinicaltrials.gov/study/NCT00557193"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","leukaemia","all-infant"],"sections":[],"technologies":[],"targets":[],"drugs":["asparaginase","cyclophosphamide","cytarabine","daunorubicin","dexamethasone","etoposide","filgrastim","leucovorin","mercaptopurine","methotrexate","prednisone","vincristine"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00557193","phase":"3","setting":"A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807)","sponsor":"Children's Oncology Group","started":"2008-01-15","startedType":"actual","yearReported":2018,"enrolled":218,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)","primary":true,"unit":"%","arms":[{"name":"Arm C (Safety/Efficacy Dose Level 2)","n":67,"value":35.82,"note":"90% CI 25.98 to 45.66; Figures from the ClinicalTrials.gov results section (first posted 2018-12-10), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00557193?tab=results"}]},{"id":"nct00002658","kind":"trial","name":"Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia","aka":[],"tldr":"A phase 3 trial of Filgrastim, Amsacrine, Cyclophosphamide, Cytarabine, Daunorubicin, Etoposide, Idarubicin, Mitoxantrone, Thioguanine and Tretinoin in Leukaemia, run by Medical Research Council, with a status the registry has not verified recently.","summary":"Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia is a phase 3 interventional study registered as NCT00002658 by Medical Research Council, with 2000 participants planned, started 1994-01. Interventions recorded: filgrastim, amsacrine, cyclophosphamide, cytarabine, daunorubicin hydrochloride, etoposide, idarubicin, mitoxantrone hydrochloride, thioguanine, tretinoin, allogeneic bone marrow transplantation, autologous bone marrow transplantation, peripheral blood stem cell transplantation, radiation therapy. Conditions recorded: Leukemia, Neutropenia.\n\nLinked to the drug Amsacrine because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00002658","url":"https://clinicaltrials.gov/study/NCT00002658"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["filgrastim","amsacrine","cyclophosphamide","cytarabine","daunorubicin","etoposide","idarubicin","mitoxantrone","thioguanine","tretinoin-atra"],"companies":["mrc-ctu"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002658","phase":"3","setting":"ACUTE MYELOID LEUKAEMIA TRIAL 12","sponsor":"Medical Research Council","started":"1994-01","enrolled":2000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00016276","kind":"trial","name":"Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer","aka":[],"tldr":"A phase 3 trial of Dexrazoxane, Doxorubicin, Cyclophosphamide, Paclitaxel / nab-paclitaxel, Trastuzumab and Tamoxifen in Inflammatory breast cancer and Breast cancer, run by National Cancer Institute (NCI), recorded as terminated on the registry.","summary":"Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer is a phase 3 interventional study registered as NCT00016276 by National Cancer Institute (NCI), with 396 participants recorded, started 2001-05 and due to reach its primary completion in 2005-03. Interventions recorded: dexrazoxane hydrochloride, doxorubicin hydrochloride, cyclophosphamide, paclitaxel, trastuzumab, therapeutic conventional surgery, radiation therapy, tamoxifen citrate, laboratory biomarker analysis. Conditions recorded: Cardiac Toxicity, Inflammatory Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IV Breast Cancer.\n\nLinked to the drug Dexrazoxane because the registry names it among its interventions and Inflammatory breast cancer and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00016276","url":"https://clinicaltrials.gov/study/NCT00016276"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["inflammatory-breast-cancer","breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["dexrazoxane","doxorubicin","cyclophosphamide","paclitaxel","trastuzumab","tamoxifen"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00016276","phase":"3","setting":"A 2X2X2 Factorial Randomized Phase III Trial Of Multimodality Therapy Comparing 4 Cycles Of Doxorubicin And Cyclophosphamide With Or Without Dexrazoxane (AC+/-Z) Followed By 12 Weeks Of Weekly Paclitaxel With Or Without Trastuzumab (T+/-H) Followed By Local Therapy Followed By 40 Weeks Of Weekly Trastuzumab Or None In Women With HER-2+ STAGE IIIA, IIIB OR REGIONAL STAGE IV BREAST CANCER","sponsor":"National Cancer Institute (NCI)","started":"2001-05","enrolled":396,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07281716","kind":"trial","name":"Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC","aka":[],"tldr":"A phase 1/2 trial of toripalimab in colorectal cancer, run by Dan Feng, now recruiting.","summary":"Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC is a phase 1/2, interventional study registered as NCT07281716 by Dan Feng, with a registry enrolment figure of 24 participants, started 2025-12-01 and due to reach its primary completion in 2028-12-15. Interventions recorded: Nadunolimab; Toripalimab. Conditions listed: Metastatic Microsatellite Stable Colorectal Carcinoma. Primary outcome: Dose-Limiting Toxicities (DLTs); Objective Response Rate (ORR). Colorectal eligibility wording from the registry: \"A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: o Has not undergone a hysterectomy or bilateral oophorectomy; or o Has not been naturally postmenopausal for at le\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07281716","url":"https://clinicaltrials.gov/study/NCT07281716"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":["coherus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07281716","phase":"1/2","setting":"A Phase 1b/2 Study of Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC)","sponsor":"Dan Feng","started":"2025-12-01","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04969887","kind":"trial","name":"Combination Immunotherapy in Rare Cancers Under InvesTigation","aka":["MOST-CIRCUIT"],"tldr":"A phase 2 trial of nivolumab and ipilimumab in gallbladder cancer and other biliary tract cancers, run by Olivia Newton-John Cancer Research Institute, active and no longer recruiting.","summary":"Combination Immunotherapy in Rare Cancers Under InvesTigation is a phase 2 interventional study registered as NCT04969887 by Olivia Newton-John Cancer Research Institute, with a registry enrolment figure of 240 participants, started 2021-08-03 and due to reach its primary completion in 2025-03-01. Interventions recorded: Ipilimumab, Nivolumab. Conditions listed: Advanced Biliary Tract Cancer, Neuroendocrine Tumors, Female Reproductive System Neoplasm, MSI-H Solid Malignant Tumor. Gallbladder cancer is named in the registry entry: \"* a) Histologically confirmed Neuroendocrine cancers: Atypical bronchial carcinoid, neuroendocrine carcinoma and Grade 3 NETs independent of primary site (SCLC excluded); Biliary Tract Cancers: Intrahepatic cholangiocarc\". Sites: Australia, New Zealand. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04969887","url":"https://clinicaltrials.gov/study/NCT04969887"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04969887-jama-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04969887","phase":"2","setting":"Ipilimumab and Nivolumab Combination Therapy in Patients With Selected Immunotherapy Sensitive Advanced Rare Cancers","sponsor":"Olivia Newton-John Cancer Research Institute","started":"2021-08-03","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04390399","kind":"trial","name":"Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of Nogapendekin alfa inbakicept, Aldoxorubicin, Gemcitabine and Cyclophosphamide in pancreatic ductal adenocarcinoma, run by ImmunityBio, Inc., active and no longer recruiting.","summary":"Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer is a phase 2 interventional study registered as NCT04390399 by ImmunityBio, Inc., with 328 participants enrolled, started 2020-07-21 and due to reach its primary completion in 2025-10-13. Interventions recorded: N-803, Aldoxorubicin HCl, PD-L1 t-haNK, Nab-paclitaxel, Gemcitabine and Cyclophosphamide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04390399","url":"https://clinicaltrials.gov/study/NCT04390399"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["nogapendekin-alfa","aldoxorubicin","gemcitabine","cyclophosphamide"],"companies":["immunitybio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04390399","phase":"2","setting":"Open-label, Randomized, Comparative Phase 2 Study of Combination Immunotherapy Plus Standard-of-care Chemotherapy Versus Standard-of-care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer","sponsor":"ImmunityBio, Inc.","started":"2020-07-21","startedType":"actual","enrolled":328,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07762703","kind":"trial","name":"Combination Immunotherapy Treatment for Locally Advanced Unresectable or Metastatic, PD-L1 Negative (CPS<10), gBRCA Negative, Triple Negative Breast Cancer Incl","aka":[],"tldr":"A phase 1/2 trial of pembrolizumab and aspirin in triple-negative breast cancer, run by BreakBio Corp, not yet recruiting.","summary":"Combination Immunotherapy Treatment for Locally Advanced Unresectable or Metastatic, PD-L1 Negative (CPS<10), gBRCA Negative, Triple Negative Breast Cancer Including BreakVax ImmunoTreatment (Designed and Manufactured Per Patient), Chemotherapy and Anti PD-1 Therapy is a phase 1/2, randomised interventional study registered as NCT07762703 by BreakBio Corp, with a registry enrolment figure of 10 participants, started 2026-09 and due to reach its primary completion in 2030-09. Interventions recorded: BreakVax; Ipilimumab 2.5 mg; Pembrolizumab; Standard-of-care chemotherapy; Losartan and aspirin. Conditions listed: Triple-Negative Breast Cancer (TNBC). Triple-negative eligibility wording from the registry: \"Patients with histologically confirmed locally advanced unresectable or metastatic, PD-L1 negative (CPS \\<10), gBRCA-negative TNBC who received first-line ADC treatment and experienced disease progression and have sent 200mg (approximately) of tumor tissue (fresh tissue immersed in AllProtect then f\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07762703","url":"https://clinicaltrials.gov/study/NCT07762703"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","aspirin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07762703","phase":"1/2","setting":"Phase 1/2 Trial of a Combination Immunotherapy Treatment for Solid Tumors Including BreakVax ImmunoTreatment (Designed and Manufactured Per Patient), Chemotherapy and Anti PD-1 Therapy","sponsor":"BreakBio Corp","started":"2026-09","startedType":"estimated","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04082364","kind":"trial","name":"Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer","aka":[],"tldr":"A phase 2/3 trial of Margetuximab, Retifanlimab and Trastuzumab in HER2-positive gastric cancer, run by MacroGenics, completed.","summary":"Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer is a phase 2/3 interventional study registered as NCT04082364 by MacroGenics, with 82 participants recorded, started 2019-09-30 and reaching its primary completion in 2024-01-15. Interventions recorded: margetuximab, Retifanlimab, Tebotelimab, Trastuzumab, Chemotherapy. Conditions recorded: Gastric Cancer, Gastroesophageal Junction Cancer, HER2-positive Gastric Cancer.\n\nLinked to the drug Margetuximab because the registry names it among its interventions and HER2-positive gastric cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04082364","url":"https://clinicaltrials.gov/study/NCT04082364"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["margetuximab","retifanlimab","trastuzumab"],"companies":["macrogenics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04082364","phase":"2/3","setting":"A Phase 2/3 Trial to Evaluate Margetuximab in Combination With INCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in Patients With Metastatic or Locally Advanced, Treatment-naïve, HER2-Positive Gastric or Gastroesophageal Junction Cancer","sponsor":"MacroGenics","started":"2019-09-30","startedType":"actual","yearReported":2025,"enrolled":82,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR) for Non-microsatellite Instability-high (Non-MSI-H) Participants (Cohort A) Using Investigator-assessed Radiology Reviews","primary":true,"unit":"%","arms":[{"name":"Chemotherapy-free Arm","n":48,"value":52.1,"note":"95% CI 37.2 to 66.7; Figures from the ClinicalTrials.gov results section (first posted 2025-04-22), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04082364?tab=results"}]},{"id":"nct01886105","kind":"trial","name":"Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma","aka":[],"tldr":"A phase 2 trial of Samarium-153 lexidronam in Osteosarcoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, recorded as terminated on the registry.","summary":"Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma is a phase 2 interventional study registered as NCT01886105 by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, with 4 participants recorded, started 2013-08-19 and due to reach its primary completion in 2015-12-11. Interventions recorded: Sm-EDTMP, Autologous Stem Cell Infusion, External Beam Radiotherapy. Conditions recorded: Metastatic Osteosarcoma.\n\nLinked to the drug Samarium-153 lexidronam because the registry names it among its interventions and Osteosarcoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01886105","url":"https://clinicaltrials.gov/study/NCT01886105"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["osteosarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["samarium-153-lexidronam"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01886105","phase":"2","setting":"Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","started":"2013-08-19","startedType":"actual","yearReported":2019,"enrolled":4,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Treated Participants With 6-month Progression Free Survival","primary":true,"unit":"participants","arms":[{"name":"SmEDTMP/Autologous Stem Cell Infusion/RT","n":4,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2019-10-29), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01886105?tab=results"}]},{"id":"nct05757336","kind":"trial","name":"Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer","aka":[],"tldr":"A phase 2 trial of sintilimab, gemcitabine, nab-paclitaxel and bevacizumab in gallbladder cancer, run by Lu Wang, MD, PhD, now recruiting.","summary":"Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer is a phase 2 interventional study registered as NCT05757336 by Lu Wang, MD, PhD, with a registry enrolment figure of 50 participants, started 2022-12-22 and due to reach its primary completion in 2024-12-22. Interventions recorded: Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab. Conditions listed: Gallbladder Cancer, Initially Unresectable, the First Line Treatment. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05757336","url":"https://clinicaltrials.gov/study/NCT05757336"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["sintilimab","gemcitabine","nab-paclitaxel","bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05757336","phase":"2","setting":"Explore the Efficacy and Safety of Sintilimab Plus Bevacizumab Combined With Gemcitabine and Albumin-paclitaxel (AG Regimen) in First-line Treatment of Initial Unresectable Gallbladder Cancer: a Phase II Clinical Study","sponsor":"Lu Wang, MD, PhD","started":"2022-12-22","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05874414","kind":"trial","name":"Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma","aka":[],"tldr":"A phase 1/2 trial of Trametinib in biliary tract cancer, run by Genfit, now recruiting.","summary":"Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma is a phase 1/2 interventional study registered as NCT05874414 by Genfit, with 98 participants planned, started 2023-08-21 and due to reach its primary completion in 2027-12. Interventions recorded: GNS561 + Trametinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05874414","url":"https://clinicaltrials.gov/study/NCT05874414"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["trametinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05874414","phase":"1/2","setting":"Phase 1b/2a Study of GNS561 in Combination With Trametinib in Advanced KRAS Mutated Cholangiocarcinoma","sponsor":"Genfit","started":"2023-08-21","startedType":"actual","enrolled":98,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07467590","kind":"trial","name":"Combination of High and Low-Dose Radiotherapy With Immune Therapy and TKI in Advanced Colorectal Cancer: A Phase II Study","aka":["TRIUNITE-07"],"tldr":"A phase 2 trial in colorectal cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, not yet recruiting.","summary":"Combination of High and Low-Dose Radiotherapy With Immune Therapy and TKI in Advanced Colorectal Cancer: A Phase II Study is a phase 2, interventional study registered as NCT07467590 by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, with a registry enrolment figure of 33 participants, started 2026-04-01 and due to reach its primary completion in 2028-04-01. Interventions recorded: High- and Low-Dose Radiotherapy; Anti-Angiogenic TKI and Anti-PD-1 Therapy. Conditions listed: Refractory Colorectal Cancer; Radiotherapy-Induced Immune Priming; Immune Response. Primary outcome: Objective Response Rate (ORR). Colorectal eligibility wording from the registry: \"Histologically confirmed microsatellite stable (MSS) / proficient mismatch repair (pMMR) colorectal adenocarcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07467590","url":"https://clinicaltrials.gov/study/NCT07467590"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07467590","phase":"2","setting":"Efficacy of Combined High and Low-Dose Radiotherapy With Immune Therapy and Tyrosine Kinase Inhibitors (TKI) as a Second-Line or Later Treatment Strategy for Advanced Colorectal Cancer: A Single-Arm, Open-Label Phase II Study","sponsor":"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","started":"2026-04-01","startedType":"estimated","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04516681","kind":"trial","name":"Combination of IV Ascorbic Acid and Adebrelimab in Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 3 trial of adebrelimab in colorectal cancer, run by Fudan University, now recruiting.","summary":"Combination of IV Ascorbic Acid and Adebrelimab in Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT04516681 by Fudan University, with a registry enrolment figure of 400 participants, started 2024-12-01 and due to reach its primary completion in 2025-12-01. Interventions recorded: Ascorbic acid; FOLFOX Protocol; Adebrelimab. Conditions listed: Colorectal Cancer; Vitamin C; GLUT3. Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"* Age≥18 years, ≤75 years; Histologically proven peritoneal metastatic adenocarcinoma of colorectal cancer, unresectable metastatic disease; IHC confirmed strong positive GLUT3; measurable disease; Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1; Life expectancy of at least 12 we\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04516681","url":"https://clinicaltrials.gov/study/NCT04516681"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04516681","phase":"3","setting":"Vitamin C Intravenously With Chemotherapy and Adebrelimab in Metastatic Colorectal Cancer With High Expresison Level of GLUT3","sponsor":"Fudan University","started":"2024-12-01","startedType":"estimated","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07151872","kind":"trial","name":"Combination of QLS31905 and Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of gemcitabine, cisplatin, oxaliplatin and capecitabine in gallbladder cancer and other biliary tract cancers, run by Qilu Pharmaceutical Co., Ltd., not yet recruiting.","summary":"Combination of QLS31905 and Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT07151872 by Qilu Pharmaceutical Co., Ltd., with a registry enrolment figure of 120 participants, started 2025-09 and due to reach its primary completion in 2026-10. Interventions recorded: QLS31905 for Injection, Gemcitabine Hydrochloride for Injection, Cisplatin for Injection, QL2107 Injection, Oxaliplatin Injection, Capecitabine Tablets. Conditions listed: CLDN18.2-positive Advanced Biliary Tract Cancer. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07151872","url":"https://clinicaltrials.gov/study/NCT07151872"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine","cisplatin","oxaliplatin","capecitabine"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07151872","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 for Injection in Combination With Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2025-09","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03259867","kind":"trial","name":"Combination of TATE and PD-1 Inhibitor in Liver Cancer","aka":["TATE-PD1"],"tldr":"A phase 2 trial of Nivolumab in hepatocellular carcinoma, run by Teclison Ltd., now recruiting.","summary":"Combination of TATE and PD-1 Inhibitor in Liver Cancer is a phase 2 interventional study registered as NCT03259867 by Teclison Ltd., with 54 participants planned, started 2017-07-01 and due to reach its primary completion in 2026-12-30. Interventions recorded: Nivolumab Injectable Product, Trans-arterial tirapazamine embolization. Conditions listed: Hepatocellular Carcinoma, Gastric Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03259867","url":"https://clinicaltrials.gov/study/NCT03259867"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["teclison"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03259867","phase":"2","setting":"Phase IIA Single-Arm Study of Treatment of Patients With Advanced Liver Cancer With a Combination of TATE (Transarterial Tirapazamine Embolization) Followed by an Anti-PD-1 Monoclonal Antibody","sponsor":"Teclison Ltd.","started":"2017-07-01","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05609578","kind":"trial","name":"Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation","aka":[],"tldr":"A phase 2 trial of Adagrasib, Pembrolizumab, Pemetrexed, Carboplatin and Cisplatin in non-small-cell lung cancer, run by Mirati Therapeutics Inc., active and no longer recruiting.","summary":"Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation is a phase 2 interventional study registered as NCT05609578 by Mirati Therapeutics Inc., with 90 participants enrolled, started 2022-11-22 and due to reach its primary completion in 2026-09-30. Interventions recorded: Adagrasib oral dose of 400 mg twice daily tablets, Pembrolizumab, Chemotherapy: Pemetrexed and Cisplatin/Carboplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05609578","url":"https://clinicaltrials.gov/study/NCT05609578"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["adagrasib","pembrolizumab","pemetrexed","carboplatin","cisplatin"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05609578","phase":"2","setting":"A Phase 2 Trial of Combination Therapies With Adagrasib in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","sponsor":"Mirati Therapeutics Inc.","started":"2022-11-22","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06411600","kind":"trial","name":"Combination Therapy for BRAF-V600E Metastatic CRCm","aka":["BRAVE"],"tldr":"A phase 2 trial of encorafenib, cetuximab and bevacizumab (glioblastoma use) in colorectal cancer, run by Vall d'Hebron Institute of Oncology, now recruiting.","summary":"Combination Therapy for BRAF-V600E Metastatic CRCm is a phase 2, interventional study registered as NCT06411600 by Vall d'Hebron Institute of Oncology, with a registry enrolment figure of 94 participants, started 2024-05-17 and due to reach its primary completion in 2027-05-01. Interventions recorded: Encorafenib; Cetuximab; Bevacizumab. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Progression-Free Survival (PFS). Colorectal eligibility wording from the registry: \"5 x ULN is allowed if direct (conjugated) ≤1\". Sites: Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06411600","url":"https://clinicaltrials.gov/study/NCT06411600"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["encorafenib","cetuximab","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06411600","phase":"2","setting":"Bevacizumab Plus encoRAfenib-cetuximab in BRAF-V600E Mutated Metastatic Colorectal Cancer, a Phase II Study With a Safety lead-in Cohort, the BRAVE Trial","sponsor":"Vall d'Hebron Institute of Oncology","started":"2024-05-17","startedType":"actual","enrolled":94,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06686030","kind":"trial","name":"Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer","aka":[],"tldr":"A phase 2 trial of Ivonescimab, Olaparib in ovarian cancer, run by Akeso, now recruiting.","summary":"Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer is a phase 2 interventional study registered as NCT06686030 by Akeso, with 150 participants planned, started 2025-02-17 and due to reach its primary completion in 2027-10. Interventions recorded: AK112 low dose, Chemotherapy, Olaparib, AK112 high dose. Conditions listed: Platinum-sensitive Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06686030","url":"https://clinicaltrials.gov/study/NCT06686030"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["ivonescimab","olaparib"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06686030","phase":"2","setting":"An Exploratory, Multi-cohort Phase II Study of Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer","sponsor":"Akeso","started":"2025-02-17","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05171660","kind":"trial","name":"Combination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 3 trial of sintilimab, bevacizumab (glioblastoma use), fOLFOX (5-FU, leucovorin, oxaliplatin) and capecitabine in colorectal cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, active but no longer recruiting.","summary":"Combination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT05171660 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 446 participants, started 2022-02-08 and due to reach its primary completion in 2026-12-30. Interventions recorded: Sintilimab; Bevacizumab; Oxaliplatin; Capecitabine. Conditions listed: Colorectal Cancer Stage IV. Primary outcome: Progression free survival time. Colorectal eligibility wording from the registry: \"Metastatic colorectal adenocarcinoma confirmed by histology, metastases cannot be removed\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05171660","url":"https://clinicaltrials.gov/study/NCT05171660"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["sintilimab","bevacizumab-glioma","folfox","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05171660","phase":"3","setting":"A Randomized, Open, Multicenter Phase III Clinical Trial of Combination of Sintilimab Injection (IBI308) and XELOX+Bevacizumab Compared With XELOX+Bevacizumab as 1st Line Therapy of RAS-Mutant Metastatic Colorectal Cancer","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2022-02-08","startedType":"actual","enrolled":446,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03937830","kind":"trial","name":"Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma","aka":[],"tldr":"A phase 2 trial of durvalumab, tremelimumab and bevacizumab in gallbladder cancer and other biliary tract cancers, run by National Cancer Institute (NCI), active and no longer recruiting.","summary":"Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma is a phase 2 interventional study registered as NCT03937830 by National Cancer Institute (NCI), with a registry enrolment figure of 27 participants, started 2021-03-10 and due to reach its primary completion in 2026-12-31. Interventions recorded: durvalumab, Doxorubicin-Eluting Beads, TACE, bevacizumab, Tremelimumab. Conditions listed: Hepatocellular Cancer, Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma. Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03937830","url":"https://clinicaltrials.gov/study/NCT03937830"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["durvalumab","tremelimumab","bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03937830","phase":"2","setting":"A Phase II Study of Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinoma (BTC)","sponsor":"National Cancer Institute (NCI)","started":"2021-03-10","startedType":"actual","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05927142","kind":"trial","name":"Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for The","aka":["DURIPANC"],"tldr":"A phase 1/2 trial of durvalumab in pancreatic cancer, run by Joachim Aerts, MD PhD, now recruiting.","summary":"Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy is a phase 1/2, interventional study registered as NCT05927142 by Joachim Aerts, MD PhD, with a registry enrolment figure of 43 participants, started 2024-01-09 and due to reach its primary completion in 2026-04. Interventions recorded: Durvalumab; Rintatolimod. Conditions listed: Metastatic Pancreatic Cancer. Primary outcome: Phase Ib: Determine safety of combination therapy with durvalumab and rintatolimod; Phase II: Determine the clinical benefit rate of combination therapy with durvalumab and rintatolimod.. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically (Bethesda 5 or 6) confirmed metastatic pancreatic cancer, as indicated by a definite cytology/histology report\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05927142","url":"https://clinicaltrials.gov/study/NCT05927142"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05927142","phase":"1/2","setting":"Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy","sponsor":"Joachim Aerts, MD PhD","started":"2024-01-09","startedType":"actual","enrolled":43,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07580339","kind":"trial","name":"Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, not yet recruiting.","summary":"Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT07580339 by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, with a registry enrolment figure of 30 participants, started 2026-10 and due to reach its primary completion in 2030-10. Interventions recorded: DCSZ11; Radiation; Capecitabine; Oxaliplatin. Conditions listed: Rectal Cancer. Primary outcome: Composite Complete Response (compCR) Rate; Number of participants experiencing a drug-related toxicity requiring treatment discontinuation. Colorectal eligibility wording from the registry: \"* Rectal cancer (with tumor tissue present at or below the peritoneal reflection) as determined by MRI pelvis or endoscopic ultrasound\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07580339","url":"https://clinicaltrials.gov/study/NCT07580339"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07580339","phase":"2","setting":"Combining CD93 Inhibition (DCSZ11) With Short Course Radiation and Chemotherapy as Part of Total Neoadjuvant Treatment (TNT) for High-risk Mismatch Repair Proficient (pMMR) Locally Advanced Rectal Cancer (LARC)","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","started":"2026-10","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06312670","kind":"trial","name":"Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer","aka":[],"tldr":"A phase 2 trial of Masofaniten and Enzalutamide in Metastatic hormone-sensitive prostate cancer and Prostate cancer, run by Pedro Barata, MD, MSc, completed.","summary":"Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer is a phase 2 interventional study registered as NCT06312670 by Pedro Barata, MD, MSc, with 13 participants recorded, started 2024-05-16 and reaching its primary completion in 2025-01-09. Interventions recorded: EPI-7386, Enzalutamide, Androgen Deprivation Therapy (ADT). Conditions recorded: Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Prostate Cancer, Prostate Adenocarcinoma.\n\nLinked to the drug Masofaniten because the registry names it among its interventions and Metastatic hormone-sensitive prostate cancer and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06312670","url":"https://clinicaltrials.gov/study/NCT06312670"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate-mhspc","prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["masofaniten","enzalutamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06312670","phase":"2","setting":"Phase 2 Trial Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer","sponsor":"Pedro Barata, MD, MSc","started":"2024-05-16","startedType":"actual","enrolled":13,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05909423","kind":"trial","name":"Combining Intratumoral Flu Vaccine and Systemic Pembrolizumab in Patients With Early pMMR Colorectal Cancer","aka":["FLU-IMMUNE"],"tldr":"A phase 2 trial of pembrolizumab in colorectal cancer, run by Zealand University Hospital, not yet recruiting.","summary":"Combining Intratumoral Flu Vaccine and Systemic Pembrolizumab in Patients With Early pMMR Colorectal Cancer is a phase 2, interventional study registered as NCT05909423 by Zealand University Hospital, with a registry enrolment figure of 21 participants, started 2023-09-01 and due to reach its primary completion in 2025-09-01. Interventions recorded: Influenza vaccine; Pembrolizumab. Conditions listed: Colorectal Cancer. Primary outcome: Pathological response. Colorectal eligibility wording from the registry: \"* Have histologically confirmed localized pMMR stage cT1N0M0 to cT4N2M0 (stage I to III) colorectal adenocarcinoma\". Sites: Denmark. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05909423","url":"https://clinicaltrials.gov/study/NCT05909423"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","shared-antigen-vaccine"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05909423","phase":"2","setting":"Combining Intratumoral Flu Vaccine and Systemic Pembrolizumab in Patients With Early pMMR Colorectal Cancer - the FLU-IMMUNE Trial.","sponsor":"Zealand University Hospital","started":"2023-09-01","startedType":"estimated","enrolled":21,"enrolledBasis":"registry","outcomes":[]},{"id":"combomatch","kind":"trial","name":"ComboMATCH (EAY191)","aka":["Combo-MATCH","EAY191","NCI ComboMATCH"],"tldr":"ComboMATCH is the sequel to NCI-MATCH. Its lesson was that one targeted drug for one mutation rarely works, so this trial tests pairs of drugs chosen because laboratory models showed the pair beats either alone.","summary":"ComboMATCH opened in April 2023 under ECOG-ACRIN with the same national machinery as NCI-MATCH but a different entry route: instead of a single central assay, patients can be registered on the strength of a genomic report from any NCI-designated laboratory, which removes the biopsy and turnaround delay that kept many NCI-MATCH patients from ever being assigned.\n\nEach sub-study pairs a targeted drug with a second agent, chosen where patient-derived xenograft or other preclinical work showed the combination overcomes the resistance that defeated single agents, and several sub-studies are randomised against the single drug so that the contribution of the partner is measured rather than assumed. The registration protocol plans for close to 3,000 patients across the sub-studies.\n\nNothing has reported yet. What the trial is meant to change is the evidentiary standard for precision oncology: if matched combinations succeed where NCI-MATCH's single agents failed, the genotype-first approach survives in a new form; if they do not, the lesson will be that tissue and lineage matter more than the alteration list.","status":"recruiting","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT05564377","url":"https://clinicaltrials.gov/study/NCT05564377"}],"tags":[],"related":[],"cancers":["rare-cancers"],"sections":[],"technologies":["cgp","kinase-inhibitors"],"targets":[],"drugs":[],"companies":["ecog-acrin"],"institutions":["nci"],"pathways":[],"terms":["master-protocol","basket-umbrella-platform"],"trials":["nci-match"],"people":[],"bottlenecks":["b-trial-design"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05564377","phase":"platform","setting":"Advanced solid tumours with alterations for which preclinical evidence supports a specific two-drug combination: a registration protocol routes patients from any accredited genomic report to randomised or single-arm combination sub-studies","sponsor":"National Cancer Institute and ECOG-ACRIN","result":"Recruiting; no sub-study has reported.","started":"2023-04-07","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"combomatch-binimetinib-folfox","kind":"trial","name":"ComboMATCH: FOLFOX with or without binimetinib in second-line biliary tract cancer with MAPK pathway alterations","aka":["ComboMATCH biliary"],"tldr":"Part of the American ComboMATCH precision-medicine programme, this trial adds the MEK inhibitor binimetinib to FOLFOX for people whose bile duct or gallbladder cancer carries a KRAS or related pathway mutation, the most common gallbladder cancer drivers.","summary":"This ComboMATCH treatment trial (NCT05564403) randomises patients with histologically confirmed unresectable or recurrent biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma or gallbladder cancer) and a confirmed RAS/RAF/MEK/ERK pathway mutation by any CLIA-certified method, excluding BRAF V600E, to second-line FOLFOX with or without binimetinib. The primary endpoint is overall survival; 66 patients are planned at 207 US sites, the trial opened in February 2024, is active but no longer recruiting, and lists primary completion in October 2026. KRAS mutations are among the most frequent alterations in gallbladder cancer, and this is one of the few trials that selects biliary patients on MAPK pathway status rather than treating them as one group.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05564403","url":"https://clinicaltrials.gov/study/NCT05564403"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["kinase-inhibitors","cytotoxic-chemotherapy","platinum"],"targets":["kras"],"drugs":["binimetinib","folfox","fluorouracil","oxaliplatin","leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":["basket-umbrella-platform"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05564403","phase":"2","setting":"Unresectable or recurrent biliary tract cancer (intrahepatic, extrahepatic or gallbladder) with a RAS/RAF/MEK/ERK pathway mutation other than BRAF V600E, after first-line therapy: FOLFOX with or without binimetinib, randomised, primary endpoint overall survival","sponsor":"National Cancer Institute (NCI)","started":"2024-02-09","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"comet-dcis","kind":"trial","name":"COMET (Comparison of Operative versus Monitoring and Endocrine Therapy)","aka":["COMET","AFT-25"],"tldr":"COMET asked whether women with low-risk DCIS could safely be watched rather than operated on; after two years the rate of invasive cancer in the monitored group was no worse than with surgery, so careful monitoring is now a reasonable choice for some women.","summary":"Most ductal carcinoma in situ is treated with surgery and often radiotherapy although only a fraction would ever become invasive. COMET, run by the Alliance Foundation Trials group, was a pragmatic randomised non-inferiority trial of 995 women aged 40 or over with low-risk (grade 1 or 2, hormone receptor-positive, HER2-negative) DCIS, comparing active monitoring with mammography every six months, with endocrine therapy offered, against standard surgery with or without radiotherapy. The primary endpoint was the rate of ipsilateral invasive cancer at two years.\n\nAt two years the invasive cancer rate in the monitoring arm was not inferior to that in the surgery arm, and quality of life was similar. The follow-up is short and many monitored women's cancers were found at planned surgery, so longer results and the parallel LORD and LORIS trials are awaited, but COMET is the first randomised evidence that active monitoring of low-risk DCIS is safe in the short term.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02926911","url":"https://clinicaltrials.gov/study/NCT02926911"}],"tags":["subtype-trials"],"related":[],"cancers":["ductal-carcinoma-in-situ","breast-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["tamoxifen","letrozole"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["shelley-hwang"],"bottlenecks":[],"keyPapers":["paper-comet-dcis-jama-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02926911","phase":"3","setting":"Low-risk, hormone receptor-positive, HER2-negative ductal carcinoma in situ in women aged 40 or over: active monitoring with optional endocrine therapy against guideline-concordant care (surgery with or without radiotherapy)","sponsor":"Alliance Foundation Trials","result":"At two years the rate of ipsilateral invasive cancer with active monitoring was non-inferior to guideline-concordant surgery.","started":"2017-02-22","startedType":"actual","yearReported":2024,"enrolled":997,"enrolledBasis":"registry","outcomes":[{"endpoint":"Ipsilateral invasive cancer at 2 years (non-inferiority)","primary":true,"unit":"%","arms":[{"name":"Active monitoring","n":484,"value":4.2,"note":"Difference -1.7 percentage points (upper 95% CI limit 0.95); non-inferiority bound 5 points; median follow-up 36.9 months"},{"name":"Guideline-concordant care (surgery with or without radiotherapy)","n":473,"value":5.9}],"source":"https://doi.org/10.1001/jama.2024.26698"}]},{"id":"comet-1","kind":"trial","name":"COMET-1","aka":["COMET-1","XL184-307","cabozantinib in previously treated mCRPC"],"tldr":"A drug that made bone scans look dramatically better did not make men live longer. It is the best illustration in prostate cancer that a bone scan is not the disease.","summary":"Cabozantinib inhibits MET and vascular endothelial growth factor receptors, and in phase 2 it produced bone scan resolutions in men with castration-resistant prostate cancer that were unlike anything the field had seen. COMET-1 tested whether that translated.\n\nIt randomised 1,028 heavily pretreated men 2:1 to cabozantinib 60 mg daily (682) or prednisone 5 mg twice daily (346). Median overall survival was 11.0 months with cabozantinib and 9.8 months with prednisone, hazard ratio 0.90 (95 percent confidence interval 0.76 to 1.06, stratified log-rank p=0.213). The primary endpoint was not met.\n\nBone scan response at week 12 favoured cabozantinib overwhelmingly, 42 against 3 percent (stratified Cochran-Mantel-Haenszel p<0.001), and radiographic progression-free survival was 5.6 against 2.8 months, hazard ratio 0.48 (0.40 to 0.57, p<0.001). Circulating tumour cell conversion, bone biomarkers and symptomatic skeletal events all improved. PSA outcomes did not.\n\nGrade 3 to 4 adverse events occurred in 71 percent with cabozantinib against 56 percent, and discontinuation for adverse events in 33 against 12 percent. The companion trial COMET-2, in men with bone pain, was also negative. Exelixis stopped developing cabozantinib in prostate cancer.\n\nThe dissociation between the bone scan and survival is the reason bone scan response is not accepted as a registrational endpoint. Cabozantinib changes what the isotope does in bone; it does not change what the cancer does to the man.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01605227","url":"https://clinicaltrials.gov/study/NCT01605227"},{"label":"COMET-1 (Journal of Clinical Oncology 2016)","url":"https://doi.org/10.1200/JCO.2015.65.5597"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["antiangiogenic"],"targets":["met"],"drugs":["cabozantinib","prednisone"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":["bone-metastases","castration-resistance"],"trials":["calgb-90401","tasquinimod-10tasq10"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01605227","phase":"3","setting":"Metastatic castration-resistant prostate cancer progressing after docetaxel and abiraterone or enzalutamide: cabozantinib 60 mg once daily against prednisone 5 mg twice daily, randomised 2:1, with overall survival as the primary endpoint and bone scan response at week 12 as the secondary endpoint","sponsor":"Exelixis","result":"Median overall survival 11.0 against 9.8 months (hazard ratio 0.90, 95 percent confidence interval 0.76 to 1.06, p=0.213): not met. Bone scan response at 12 weeks 42 against 3 percent and radiographic progression-free survival 5.6 against 2.8 months.","started":"2012-07","yearReported":2016,"enrolled":1028,"enrolledBasis":"randomised","enrolledNote":"1,028 men were randomly assigned at a ratio of two to one, 682 to cabozantinib and 346 to prednisone.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Cabozantinib 60 mg daily","n":682,"value":11},{"name":"Prednisone 5 mg twice daily","n":346,"value":9.8}],"hr":0.9,"ci":[0.76,1.06],"p":"0.213","source":"https://doi.org/10.1200/JCO.2015.65.5597"},{"endpoint":"Bone scan response at week 12","unit":"%","arms":[{"name":"Cabozantinib 60 mg daily","n":682,"value":42},{"name":"Prednisone 5 mg twice daily","n":346,"value":3}],"p":"<0.001","source":"https://doi.org/10.1200/JCO.2015.65.5597"},{"endpoint":"Radiographic progression-free survival (median)","unit":"months","arms":[{"name":"Cabozantinib 60 mg daily","n":682,"value":5.6},{"name":"Prednisone 5 mg twice daily","n":346,"value":2.8}],"hr":0.48,"ci":[0.4,0.57],"p":"<0.001","source":"https://doi.org/10.1200/JCO.2015.65.5597"}],"replication":"COMET-2, in men with moderate to severe bone pain, was also negative; CALGB 90401 with bevacizumab produced the same pattern of better progression-free survival and no survival benefit with a different anti-angiogenic."},{"id":"comfort-i","kind":"trial","name":"COMFORT-I","aka":["COMFORT","INCB 18424-351"],"tldr":"COMFORT-I showed that the JAK-blocking pill ruxolitinib shrank the grossly enlarged spleens of people with myelofibrosis in about four in ten patients, against almost none on placebo, and eased their fatigue, night sweats and itching; it led to the first approved drug for the disease.","summary":"COMFORT-I was a double-blind phase 3 trial in 309 patients with intermediate-2 or high-risk myelofibrosis randomised to ruxolitinib, a selective inhibitor of JAK1 and JAK2, or placebo. The primary endpoint was a spleen volume reduction of 35 percent or more at 24 weeks on MRI; secondary endpoints were durability, symptom burden on a total symptom score and overall survival.\n\nThe primary endpoint was reached by 41.9 percent of patients on ruxolitinib against 0.7 percent on placebo, symptom scores improved and later follow-up showed a survival advantage, at the cost of more anaemia and thrombocytopenia early in treatment. Ruxolitinib was approved in the United States in November 2011 for intermediate- and high-risk myelofibrosis, the first drug for the disease. Together with COMFORT-II it is the reason the myeloproliferative neoplasm pages list a JAK inhibitor for spleen and symptom control.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00952289","url":"https://clinicaltrials.gov/study/NCT00952289"}],"tags":["soc-trials"],"related":[],"cancers":["primary-myelofibrosis","myeloproliferative-neoplasms"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ruxolitinib"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-comfort-1-ruxolitinib-myelofibrosis-nejm-2012"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00952289","phase":"3","setting":"Intermediate-2 or high-risk primary myelofibrosis, post-polycythaemia vera or post-essential thrombocythaemia myelofibrosis: twice-daily oral ruxolitinib or placebo, with spleen volume by MRI at 24 weeks as the primary endpoint","sponsor":"Incyte Corporation","result":"Spleen volume reduction of 35 percent or more at 24 weeks in 41.9 percent of patients on ruxolitinib against 0.7 percent on placebo; approved in the United States in November 2011.","started":"2009-08","yearReported":2012,"enrolled":309,"enrolledBasis":"registry","outcomes":[{"endpoint":"Spleen volume reduction of 35% or more at week 24 (MRI)","primary":true,"unit":"%","arms":[{"name":"Ruxolitinib","n":155,"value":41.9},{"name":"Placebo","n":154,"value":0.7}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1110557"},{"endpoint":"Participants with a spleen volume reduction of 35% or more at week 24 (registry count)","unit":"participants","arms":[{"name":"Ruxolitinib","n":155,"value":65},{"name":"Placebo","n":154,"value":1}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT00952289?tab=results"}]},{"id":"comfort-ii","kind":"trial","name":"COMFORT-II","aka":["COMFORT","CINC424A2352"],"tldr":"COMFORT-II was the European companion to COMFORT-I: ruxolitinib shrank the spleen by more than a third in 28 percent of people with myelofibrosis after nearly a year, while not one patient on the best treatment their doctor could otherwise offer achieved that, and symptoms and quality of life improved.","summary":"COMFORT-II was an open-label phase 3 trial in Europe that randomised 219 patients with intermediate-2 or high-risk myelofibrosis two to one to ruxolitinib or best available therapy, which for most patients meant hydroxycarbamide or no treatment. The primary endpoint was a spleen volume reduction of at least 35 percent at week 48 on MRI or CT, with the same reduction at week 24 as the key secondary endpoint.\n\nAt week 48, 28 percent of the ruxolitinib group had reached the spleen endpoint against none on best available therapy, responses were durable, and role functioning and quality-of-life scores improved. Toxicity was modest, mainly anaemia and thrombocytopenia. The trial supported the European approval of ruxolitinib in 2012, and pooled long-term analyses with COMFORT-I later suggested a survival advantage.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00934544","url":"https://clinicaltrials.gov/study/NCT00934544"}],"tags":["soc-trials"],"related":[],"cancers":["primary-myelofibrosis","myeloproliferative-neoplasms"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ruxolitinib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-comfort-ii-ruxolitinib-best-available-therapy-harrison-nejm-2012"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00934544","phase":"3","setting":"Intermediate-2 or high-risk primary myelofibrosis, post-polycythaemia vera or post-essential thrombocythaemia myelofibrosis: open-label ruxolitinib against best available therapy chosen by the physician, with spleen volume at 48 weeks as the primary endpoint","sponsor":"Novartis Pharmaceuticals","result":"Spleen volume reduction of at least 35 percent at week 48 in 28 percent of patients on ruxolitinib against 0 percent on best available therapy; European approval in 2012.","started":"2009-07-01","startedType":"actual","yearReported":2012,"enrolled":219,"enrolledBasis":"registry","outcomes":[{"endpoint":"Spleen volume reduction of 35% or more at week 48 (MRI or CT)","primary":true,"unit":"%","arms":[{"name":"Ruxolitinib","value":28},{"name":"Best available therapy","value":0}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1110556"},{"endpoint":"Spleen volume reduction of 35% or more at week 48 (registry results)","unit":"%","arms":[{"name":"Ruxolitinib","value":28.5},{"name":"Best available therapy","value":0}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT00934544?tab=results"}]},{"id":"commands","kind":"trial","name":"COMMANDS","aka":[],"tldr":"COMMANDS showed that luspatercept freed more people with lower-risk myelodysplastic syndromes from blood transfusions than the erythropoietin injections that had been the first-line standard for decades.","summary":"COMMANDS was an open-label phase 3 trial of 363 patients with very low-, low- or intermediate-risk myelodysplastic syndromes who needed red cell transfusions and had not yet received an erythropoiesis-stimulating agent. They were randomised to luspatercept, which promotes late-stage red cell maturation by trapping TGF-beta superfamily ligands, or to epoetin alfa. The primary endpoint was transfusion independence for at least 12 weeks with a concurrent haemoglobin rise in the first 24 weeks.\n\nMore patients on luspatercept met the primary endpoint, with longer durations of transfusion independence, and the benefit was seen with and without ring sideroblasts. The result moved luspatercept into first-line use, with United States approval in August 2023.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03682536","url":"https://clinicaltrials.gov/study/NCT03682536"}],"tags":["subtype-trials"],"related":[],"cancers":["mds-lower-risk","mds"],"sections":[],"technologies":["transfusion-support"],"targets":[],"drugs":["luspatercept","epoetin-alfa"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["uwe-platzbecker"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03682536","phase":"3","setting":"Transfusion-dependent, erythropoiesis-stimulating agent-naive lower-risk myelodysplastic syndromes: luspatercept against epoetin alfa","sponsor":"Celgene (Bristol Myers Squibb)","result":"More patients achieved transfusion independence with a haemoglobin rise on luspatercept than on epoetin alfa; first-line approval in August 2023.","started":"2019-01-02","startedType":"actual","yearReported":2023,"enrolled":363,"enrolledBasis":"registry","outcomes":[{"endpoint":"Transfusion independence >=12 weeks with haemoglobin rise >=1.5 g/dL, weeks 1-24 (interim analysis)","primary":true,"unit":"%","arms":[{"name":"Luspatercept","n":147,"value":59,"note":"Common risk difference 26.6 (95% CI 15.8 to 37.4)"},{"name":"Epoetin alfa","n":154,"value":31}],"p":"<0.0001","source":"https://doi.org/10.1016/s0140-6736(23)00874-7"}]},{"id":"nct03711877","kind":"trial","name":"Comparative Study of Scalp Cooling System and Chemical Cold Cap (COHAIR Study)","aka":["COHAIR"],"tldr":"A phase 3 trial of Scalp cooling in Breast cancer, run by Tao OUYANG, with a status the registry has not verified recently.","summary":"Comparative Study of Scalp Cooling System and Chemical Cold Cap (COHAIR Study) is a phase 3 interventional study registered as NCT03711877 by Tao OUYANG, with 256 participants planned, started 2019-03-07 and due to reach its primary completion in 2023-12-31. Interventions recorded: Scalp cooling system, Cold cap. Conditions recorded: Primary Breast Cancer.\n\nLinked to the technology Scalp cooling because the registry names it (\"scalp cooling\") among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03711877","url":"https://clinicaltrials.gov/study/NCT03711877"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer","male-breast-cancer"],"sections":[],"technologies":["scalp-cooling"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03711877","phase":"3","setting":"Comparative Study of Scalp Cooling System and Chemical Cold Cap on Prevention of Chemotherapy-induced Alopecia in Women With Breast Cancer","sponsor":"Tao OUYANG","started":"2019-03-07","startedType":"actual","enrolled":256,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07371273","kind":"trial","name":"Comparative Study on the Short- and Long-term Efficacy of Q-ISR, Traditional Sub-ISR, and t-ISR","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Fudan University, now recruiting.","summary":"Comparative Study on the Short- and Long-term Efficacy of Q-ISR, Traditional Sub-ISR, and t-ISR is a phase 2, randomised interventional study registered as NCT07371273 by Fudan University, with a registry enrolment figure of 100 participants, started 2026-01-07 and due to reach its primary completion in 2029-01-07. Interventions recorded: Quadrant-based Intersphincteric Resection. Conditions listed: Colorectal Cancer. Primary outcome: Wexner score; LARS scores; disease-free survival. Colorectal eligibility wording from the registry: \"* (1) Rectal cancer diagnosed by digital rectal examination, colonoscopy, and combined biopsy pathology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07371273","url":"https://clinicaltrials.gov/study/NCT07371273"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07371273","phase":"2","setting":"Comparative Study on the Short- and Long-term Efficacy of Q-ISR, Traditional Sub-ISR, and t-ISR","sponsor":"Fudan University","started":"2026-01-07","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06234072","kind":"trial","name":"Comparing Astragalus Plus Gemcitabine to Gemcitabine Alone as Neoadjuvant Treatment for Pancreatic Cancer Patients","aka":[],"tldr":"A phase 2 trial of gemcitabine in pancreatic cancer, run by Shenzhen University General Hospital, not yet recruiting.","summary":"Comparing Astragalus Plus Gemcitabine to Gemcitabine Alone as Neoadjuvant Treatment for Pancreatic Cancer Patients is a phase 2, randomised interventional study registered as NCT06234072 by Shenzhen University General Hospital, with a registry enrolment figure of 120 participants, started 2024-02 and due to reach its primary completion in 2027-01. Interventions recorded: Astragalus + Gemcitabine; Gemcitabine alone. Conditions listed: Pancreatic Cancer. Primary outcome: Objective response rate (ORR). Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06234072","url":"https://clinicaltrials.gov/study/NCT06234072"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06234072","phase":"2","setting":"Comparison of Neoadjuvant Treatment for Pancreatic Cancer: Astragalus Combined With Gemcitabine Versus Gemcitabine Alone - A Single-Center, Randomized, Double-Blind Study","sponsor":"Shenzhen University General Hospital","started":"2024-02","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05768503","kind":"trial","name":"Comparing Chidamide+Sintilimab+Bev With Standard Second-line FOLFIRI+Bev in Advanced MSS/pMMR mCRC","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Comparing Chidamide+Sintilimab+Bev With Standard Second-line FOLFIRI+Bev in Advanced MSS/pMMR mCRC is a phase 3, randomised interventional study registered as NCT05768503 by Sun Yat-sen University, with a registry enrolment figure of 176 participants, started 2023-03-01 and due to reach its primary completion in 2026-01. Interventions recorded: Experimental drug; Control Rx. Conditions listed: Metastatic Microsatellite-stable Colorectal Cancer. Primary outcome: Progression-Free Survival (PFS). Colorectal eligibility wording from the registry: \"Locally advanced unresectable or metastatic colorectal adenocarcinoma (excluding mixed adenosquamous carcinoma and other pathological types) confirmed by pathological histology or cytology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05768503","url":"https://clinicaltrials.gov/study/NCT05768503"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05768503","phase":"3","setting":"Chidamide+Sintilimab+Bevacizumab Versus Standard Second-Line Therapy of FOLFIRI+Bevacizumab in Subjects With Advanced Microsatellite Stable (MSS/pMMR) Colorectal Cancer Who Have Failed Oxaliplatin-Containing First-Line Therapy","sponsor":"Sun Yat-sen University","started":"2023-03-01","startedType":"actual","enrolled":176,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07595276","kind":"trial","name":"Comparing Efficacy and Safety of Enlituo® Versus Erbitux® Plus FOLFOX in Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Stat","aka":[],"tldr":"A phase 3 trial of cetuximab in colorectal cancer, run by Taizhou Mabtech Pharmaceutical Co.,Ltd, not yet recruiting.","summary":"Comparing Efficacy and Safety of Enlituo® Versus Erbitux® Plus FOLFOX in Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status. is a phase 3, randomised interventional study registered as NCT07595276 by Taizhou Mabtech Pharmaceutical Co.,Ltd, with a registry enrolment figure of 608 participants, started 2026-06-01 and due to reach its primary completion in 2029-10-01. Interventions recorded: Enlituo®; Erbitux®. Conditions listed: Colorectal Cancer. Primary outcome: Objective Response Rate (ORR) within 16 weeks assessed by BIRC according to RECIST v1.1 criteria. Colorectal eligibility wording from the registry: \"* Participants with histologically and/or cytologically confirmed locally advanced/metastatic colorectal cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07595276","url":"https://clinicaltrials.gov/study/NCT07595276"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07595276","phase":"3","setting":"A Multicenter, Randomized, Double-blind, Phase III Clinical Study Evaluating the Efficacy and Safety of Enlituo® Plus FOLFOX Versus Erbitux® Plus FOLFOX as First-line Treatment for Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status.","sponsor":"Taizhou Mabtech Pharmaceutical Co.,Ltd","started":"2026-06-01","startedType":"estimated","enrolled":608,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06632327","kind":"trial","name":"Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of cisplatin, carboplatin, pemetrexed, gemcitabine and other drugs in lung cancer, run by Alliance for Clinical Trials in Oncology, active but no longer recruiting.","summary":"Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT06632327 by Alliance for Clinical Trials in Oncology, with a registry enrolment figure of 37 participants, started 2024-12-11 and due to reach its primary completion in 2029-04-30. Interventions recorded: Surgical Procedure; Cisplatin; Carboplatin; Pemetrexed; Gemcitabine; Docetaxel; Vinorelbine; Nivolumab; Pembrolizumab; Atezolizumab; Computed Tomography; Magnetic Resonance Imaging; Positron Emission Tomography. Conditions listed: Resectable Lung Non-Small Cell Carcinoma; Stage II Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8. Primary outcome: 3-year real-world event-free survival (rwEFS); Overall survival (OS). Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed surgically resectable stage IIA to IIIB NSCLC according to the American Joint Committee on Cancer (AJCC) 9th edition (stage IIA to IIIB NSCLC up to single station N2, according to the AJCC 8th edition)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06632327","url":"https://clinicaltrials.gov/study/NCT06632327"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin","carboplatin","pemetrexed","gemcitabine","docetaxel","vinorelbine","nivolumab","pembrolizumab","atezolizumab"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06632327","phase":"3","setting":"Perioperative Versus Adjuvant Systemic Therapy in Patients With Resectable Non-Small Cell Lung Cancer - PROSPECT LUNG","sponsor":"Alliance for Clinical Trials in Oncology","started":"2024-12-11","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06782932","kind":"trial","name":"Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of balstilimab and cyclophosphamide in pancreatic cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, now recruiting.","summary":"Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer is a phase 1/2, interventional study registered as NCT06782932 by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, with a registry enrolment figure of 38 participants, started 2025-05-27 and due to reach its primary completion in 2028-12. Interventions recorded: AGEN2373; Balstilimab; Cyclophosphamide; GVAX; AGEN2373 (RP2D); Balstilimab; mKRASvax. Conditions listed: Pancreatic Cancer. Primary outcome: Dose Limiting Toxicities in Phase I participants; Number of participants experiencing Grade 3 or Higher study drug-related toxicities; Number of participants who form Intratumoral tertiary lymphoid structures (TLS). Pancreatic eligibility wording from the registry: \"* Have a newly diagnosed, biopsy-proven adenocarcinoma of the pancreas\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06782932","url":"https://clinicaltrials.gov/study/NCT06782932"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","shared-antigen-vaccine"],"targets":[],"drugs":["balstilimab","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06782932","phase":"1/2","setting":"A Pilot Study Comparing Neoadjuvant and Adjuvant GVAX vs a Mutated KRAS Peptide Vaccine Given With Anti-PD-1 and Anti-CD137 for the Treatment of Surgically Resectable Pancreatic Adenocarcinoma","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","started":"2025-05-27","startedType":"actual","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01993810","kind":"trial","name":"Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer","aka":[],"tldr":"A phase 3 trial of carboplatin, cisplatin, durvalumab, etoposide and other drugs in lung cancer, run by Radiation Therapy Oncology Group, active but no longer recruiting.","summary":"Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer is a phase 3, randomised interventional study registered as NCT01993810 by Radiation Therapy Oncology Group, with a registry enrolment figure of 330 participants, started 2014-01-03 and due to reach its primary completion in 2028-11-30. Interventions recorded: Carboplatin; Cisplatin; Durvalumab; Etoposide; Paclitaxel; Pemetrexed Disodium; Photon Beam Radiation Therapy; Proton Beam Radiation Therapy; Quality-of-Life Assessment; Questionnaire Administration. Conditions listed: Stage II Non-Small Cell Lung Cancer AJCC v7; Stage IIA Non-Small Cell Lung Carcinoma AJCC v7; Stage IIB Non-Small Cell Lung Carcinoma AJCC v7; Stage III Non-Small Cell Lung Cancer AJCC v7; Stage IIIA Non-Small Cell Lung Cancer AJCC v7; Stage IIIB Non. Primary outcome: Overall Survival. Lung eligibility wording from the registry: \"* Histologically or cytologically proven diagnosis of non-small cell lung cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01993810","url":"https://clinicaltrials.gov/study/NCT01993810"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum","proton-therapy","topoisomerase-inhibitors"],"targets":[],"drugs":["carboplatin","cisplatin","durvalumab","etoposide","paclitaxel","pemetrexed"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01993810","phase":"3","setting":"Phase III Randomized Trial Comparing Overall Survival After Photon Versus Proton Chemoradiotherapy for Inoperable Stage II-IIIB NSCLC","sponsor":"Radiation Therapy Oncology Group","started":"2014-01-03","startedType":"actual","enrolled":330,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04333537","kind":"trial","name":"Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer","aka":[],"tldr":"A phase 2/3 trial of Fludeoxyglucose F-18 in Oral cavity cancer, run by NRG Oncology, now recruiting.","summary":"Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer is a phase 2/3 interventional study registered as NCT04333537 by NRG Oncology, with 686 participants planned, started 2020-09-23 and due to reach its primary completion in 2031-04-27. Interventions recorded: Chest Radiography, Computed Tomography, Fludeoxyglucose F-18, Imaging Agent, Neck Dissection, Planar Imaging, Positron Emission Tomography, Questionnaire Administration, Sentinel Lymph Node Biopsy, Single Photon Emission Computed Tomography. Conditions recorded: Buccal Mucosa Squamous Cell Carcinoma, Floor of Mouth Squamous Cell Carcinoma, Gingival Squamous Cell Carcinoma, Hard Palate Squamous Cell Carcinoma, Lip Squamous Cell Carcinoma, Lower Alveolar Ridge Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Retromolar Trigone Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Tongue Squamous Cell Carcinoma, Upper Alveolar Ridge Squamous Cell Carcinoma.\n\nLinked to the drug Fludeoxyglucose F-18 because the registry names it among its interventions and Oral cavity cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04333537","url":"https://clinicaltrials.gov/study/NCT04333537"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["oral-cavity-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["fludeoxyglucose-f18"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04333537","phase":"2/3","setting":"Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer","sponsor":"NRG Oncology","started":"2020-09-23","startedType":"actual","enrolled":686,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04379635","kind":"trial","name":"Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)","aka":["RATIONALE-315"],"tldr":"A phase 3 trial of Tislelizumab, Cisplatin, Paclitaxel / nab-paclitaxel in non-small-cell lung cancer and small-cell lung cancer, run by BeiGene, active and no longer recruiting.","summary":"Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC) is a phase 3 interventional study registered as NCT04379635 by BeiGene, with 453 participants enrolled, started 2020-05-29 and due to reach its primary completion in 2023-08-21. Interventions recorded: Tislelizumab, Cisplatin injection, Paclitaxel injection, Pemetrexed Disodium, Placebos. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04379635","url":"https://clinicaltrials.gov/study/NCT04379635"},{"label":"RATIONALE-315 final analysis (Annals of Oncology 2026)","url":"https://doi.org/10.1016/j.annonc.2025.11.017"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab","cisplatin","paclitaxel","pemetrexed","carboplatin"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":["neotorch","nct04025879","nct03800134","keynote-671"],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04379635-lancet-respir-med-2025","paper-nct04379635-ann-oncol-2026-update"],"journals":[],"dependsOn":[],"notes":["RATIONALE-315 randomised 453 adults in China with resectable stage II to IIIA non-small-cell lung cancer 1:1 to perioperative tislelizumab (226) or placebo (227) with neoadjuvant chemotherapy, with dual primary endpoints of event-free survival and major pathological response by blinded independent central review. Median overall survival was not reached in either group. It is one of the four perioperative chemoimmunotherapy trials that, with AEGEAN, CheckMate 77T and Neotorch, established the schedule (Annals of Oncology 2026)."],"nct":"NCT04379635","phase":"3","setting":"A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy and Safety of Neoadjuvant Treatment With Tislelizumab (BGB-A317, Anti-PD-1 Antibody) or Placebo Plus Platinum-Based Doublet Chemotherapy Followed By Adjuvant Tislelizumab or Placebo in Resectable Stage II or IIIA Non-Small Cell Lung Cancer","sponsor":"BeiGene","result":"At the final analysis (median follow-up 38.5 months) overall survival favoured perioperative tislelizumab (hazard ratio 0.65, 95 percent confidence interval 0.45 to 0.93, p=0.009); 36-month overall survival 79.3 against 69.3 percent.","started":"2020-05-29","startedType":"actual","yearReported":2026,"enrolled":453,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06008106","kind":"trial","name":"Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma","aka":[],"tldr":"A phase 3 trial of Tunlametinib run by Shanghai Kechow Pharma, Inc. in melanoma, now recruiting.","summary":"Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma is a phase 3 interventional study registered as NCT06008106 by Shanghai Kechow Pharma, Inc., with 165 participants planned, started 2023-11-02. Conditions listed: Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06008106","url":"https://clinicaltrials.gov/study/NCT06008106"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["tunlametinib"],"companies":["shanghai-kechow-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06008106","phase":"3","setting":"Efficacy and Safety of Tunlametinib Capsules Versus Combination Chemotherapy of Investigator's Choice in Advanced NRAS-mutant Melanoma Patients Who Had Previously Received Immunotherapy","sponsor":"Shanghai Kechow Pharma, Inc.","started":"2023-11-02","startedType":"actual","enrolled":165,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07021261","kind":"trial","name":"Comparing UTD2 Combined With Capecitabine to Capecitabine as Adjuvant Therapy for Non-pCR TNBC Patients","aka":[],"tldr":"A phase 3 trial of utidelone and capecitabine in triple-negative breast cancer, run by Fudan University, not yet recruiting.","summary":"Comparing UTD2 Combined With Capecitabine to Capecitabine as Adjuvant Therapy for Non-pCR TNBC Patients is a phase 3, randomised interventional study registered as NCT07021261 by Fudan University, with a registry enrolment figure of 440 participants, started 2025-06-16 and due to reach its primary completion in 2030-06-16. Interventions recorded: Utidelone plus capecitabine; Capecitabine. Conditions listed: Breast Cancer; TNBC. Triple-negative eligibility wording from the registry: \"Triple-Negative Breast Cancer Confirmation\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07021261","url":"https://clinicaltrials.gov/study/NCT07021261"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["utidelone","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07021261","phase":"3","setting":"A Multicenter, Open-Label, Randomized, Phase III Study Comparing UTD2 Combined With Capecitabine to Capecitabine Monotherapy as Adjuvant Therapy for Triple-Negative Breast Cancer Patients Who Did Not Achieve Pathological Complete Response","sponsor":"Fudan University","started":"2025-06-16","startedType":"estimated","enrolled":440,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06119867","kind":"trial","name":"CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)","aka":["SPACE"],"tldr":"A phase 3 trial in colorectal cancer, run by Russian Society of Colorectal Surgeons, now recruiting.","summary":"CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE) is a phase 3, randomised interventional study registered as NCT06119867 by Russian Society of Colorectal Surgeons, with a registry enrolment figure of 430 participants, started 2023-11-14 and due to reach its primary completion in 2027-04-12. Interventions recorded: Japanese pathological investigation; European pathological investigation. Conditions listed: Colonic Neoplasms. Primary outcome: Comparision of the incidence of stage III colon cancer between European and Japanese pathological investigation methods.. Colorectal eligibility wording from the registry: \"* Patients diagnosed with colon cancer who underwent colectomy;\". Sites: Russia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06119867","url":"https://clinicaltrials.gov/study/NCT06119867"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06119867","phase":"3","setting":"Comparison Between the European and Japanese Pathological Investigation for Colon Cancer (SPACE)","sponsor":"Russian Society of Colorectal Surgeons","started":"2023-11-14","startedType":"actual","enrolled":430,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00099437","kind":"trial","name":"Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.","aka":["CONFIRM"],"tldr":"A phase 3 trial of Fulvestrant in HR-positive / HER2-negative breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy. is a phase 3 interventional study registered as NCT00099437 by AstraZeneca, with 736 participants enrolled, started 2005-02-13 and due to reach its primary completion in 2009-02-27. Interventions recorded: Fulvestrant. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00099437","url":"https://clinicaltrials.gov/study/NCT00099437"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["fulvestrant"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00099437","phase":"3","setting":"A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy","sponsor":"AstraZeneca","started":"2005-02-13","startedType":"actual","yearReported":2010,"enrolled":736,"enrolledBasis":"registry","outcomes":[{"endpoint":"Time to Progression (TTP)","primary":true,"unit":"months","arms":[{"name":"Fulvestrant 250 mg","n":374,"value":5.5,"note":"range 0 to NA; Figures from the ClinicalTrials.gov results section (first posted 2010-06-15), not from a publication"},{"name":"Fulvestrant 500 mg","n":362,"value":6.5,"note":"range 0 to NA"}],"source":"https://clinicaltrials.gov/study/NCT00099437?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"time (in months)","arms":[{"name":"Fulvestrant 250 mg","n":374,"value":22.8,"note":"range 0.2 to NA; Figures from the ClinicalTrials.gov results section (first posted 2010-06-15), not from a publication"},{"name":"Fulvestrant 500 mg","n":362,"value":25.1,"note":"range 0.1 to NA"}],"source":"https://clinicaltrials.gov/study/NCT00099437?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"Fulvestrant 250 mg","n":261,"value":14.6,"note":"Figures from the ClinicalTrials.gov results section (first posted 2010-06-15), not from a publication"},{"name":"Fulvestrant 500 mg","n":240,"value":13.8}],"source":"https://clinicaltrials.gov/study/NCT00099437?tab=results"}]},{"id":"nct02739594","kind":"trial","name":"Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma","aka":["COMPARE"],"tldr":"A phase 3 trial of Ibandronic acid and Zoledronic acid in Multiple myeloma, run by Hoffmann-La Roche, recorded as terminated on the registry.","summary":"Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma is a phase 3 interventional study registered as NCT02739594 by Hoffmann-La Roche, with 89 participants recorded, started 2006-02 and due to reach its primary completion in 2009-04. Interventions recorded: Ibandronate, Zoledronate. Conditions recorded: Multiple Myeloma.\n\nLinked to the drug Ibandronic acid because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02739594","url":"https://clinicaltrials.gov/study/NCT02739594"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["ibandronic-acid","zoledronic-acid"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02739594","phase":"3","setting":"COMPARE: Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Patients With Multiple Myeloma","sponsor":"Hoffmann-La Roche","started":"2006-02","yearReported":2016,"enrolled":89,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44","primary":true,"unit":"%","arms":[{"name":"Ibandronate","n":41,"value":9.8,"note":"95% CI 2.7 to 23.1; Figures from the ClinicalTrials.gov results section (first posted 2016-07-22), not from a publication"},{"name":"Zoledronate","n":40,"value":12.5,"note":"95% CI 4.2 to 26.8"}],"source":"https://clinicaltrials.gov/study/NCT02739594?tab=results"}]},{"id":"nct06265285","kind":"trial","name":"Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW)","aka":[],"tldr":"A phase 2 trial of nivolumab in colorectal cancer, run by Mayo Clinic, now recruiting.","summary":"Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program is a phase 2, interventional study registered as NCT06265285 by Mayo Clinic, with a registry enrolment figure of 50 participants, started 2024-04-30 and due to reach its primary completion in 2026-12-31. Interventions recorded: Home Health Encounter; Nivolumab; Patient Monitoring; Questionnaire Administration. Conditions listed: Advanced Esophageal Squamous Cell Carcinoma; Advanced Renal Cell Carcinoma; Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage IIB Cutaneous Melanoma AJCC v8; Clinical Stage IIC Cutaneous Melanoma AJCC v8; Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8; Esophageal Carcinoma; Gastroesophageal Junction Adenocarcinoma; Hepatocellular Carcinoma; Locally Advanced Urothelial Carcinoma; Lung Non-Small Cell Carcinoma; Malignant Solid Neoplasm; Metastatic Colorectal Carcinoma; Metastatic Cutaneous Melanoma; Metastatic Esophageal Squamous Cell Carcinoma; Metastatic Head and Neck Squamous Cell Carcinoma; Metastatic Urothelial Carcinoma; Recurrent Esophageal Squamous Cell Carcinoma; Recurrent Head and Neck Squamous Cell Carcinoma; Renal Cell Carcinoma; Stage III Renal Cell Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Stage IV Renal Cell Cancer AJCC v8; Unresectable Cutaneous Melanoma; Unresectable Esophageal Squamous Cell Carcinoma; Urothelial Carcinoma; Unresectable Urothelial Carcinoma. Primary outcome: Change in patient-reported rating of Cancer CARE Cancer Connected Access and Remote Expertise (CARE) after 8 weeks. Colorectal eligibility wording from the registry: \"* Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06265285","url":"https://clinicaltrials.gov/study/NCT06265285"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06265285","phase":"2","setting":"MC230716 Pilot Single-Arm, Pragmatic Trial Of In-Home Versus In-Clinic Subcutaneous Nivolumab Administration Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program","sponsor":"Mayo Clinic","started":"2024-04-30","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07554846","kind":"trial","name":"Comparison of Perioperative Immunotherapy, Adjuvant Immunotherapy or Neoadjuvant Immunotherapy for Resectable Stage II-IIIA NSCLC","aka":["ECTOP-1030"],"tldr":"A phase 3 trial in lung cancer, run by Fudan University, now recruiting.","summary":"Comparison of Perioperative Immunotherapy, Adjuvant Immunotherapy or Neoadjuvant Immunotherapy for Resectable Stage II-IIIA NSCLC is a phase 3, randomised interventional study registered as NCT07554846 by Fudan University, with a registry enrolment figure of 759 participants, started 2026-05-01 and due to reach its primary completion in 2030-05-01. Interventions recorded: Peroperative immunotherapy; Neoadjuvant immunotherapy; Adjuvant immunotherapy. Conditions listed: Resectable Stage II-IIIa NSCLC. Primary outcome: 3-year events-free survival (EFS) rate. Lung eligibility wording from the registry: \"Subjects with resectable stage II-IIIA non-small cell lung cancer (according to the AJCC 8th edition), without EGFR/ALK sensitive mutations, confirmed by histology or pathology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07554846","url":"https://clinicaltrials.gov/study/NCT07554846"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07554846","phase":"3","setting":"A Randomized, Open-label, Multicenter Phase III Clinical Trial Comparing Perioperative Immunotherapy to Adjuvant Immunotherapy or Neoadjuvant Immunotherapy With Toripalimab in Resectable Stage II-IIIA Non-small Cell Lung Cancer (ECTOP-1030)","sponsor":"Fudan University","started":"2026-05-01","startedType":"actual","enrolled":759,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04971473","kind":"trial","name":"Comparison of the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal","aka":[],"tldr":"A phase 3 trial of Thyrotropin alfa in Thyroid cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, completed.","summary":"Comparison of the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal is a phase 3 interventional study registered as NCT04971473 by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, with 201 participants recorded, started 2021-09-10 and reaching its primary completion in 2023-07-05. Interventions recorded: rhTSH. Conditions recorded: Differentiated Thyroid Cancer.\n\nLinked to the drug Thyrotropin alfa because the registry names it among its interventions and Thyroid cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04971473","url":"https://clinicaltrials.gov/study/NCT04971473"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["thyroid"],"sections":[],"technologies":[],"targets":[],"drugs":["thyrotropin-alfa"],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04971473","phase":"3","setting":"An Open, Single-arm, Self-controlled, Multi-center Phase 3 Study to Compare the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","started":"2021-09-10","startedType":"actual","enrolled":201,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04922853","kind":"trial","name":"Comparison of the Pathological Effect Between 2 and 4 Cycles Neoadjuvant CAPOX for Low/Intermediate Risk II/III Rectal Cancer","aka":["COPEC"],"tldr":"A phase 3 trial in colorectal cancer, run by West China Hospital, active but no longer recruiting.","summary":"Comparison of the Pathological Effect Between 2 and 4 Cycles Neoadjuvant CAPOX for Low/Intermediate Risk II/III Rectal Cancer is a phase 3, randomised interventional study registered as NCT04922853 by West China Hospital, with a registry enrolment figure of 554 participants, started 2021-08-26 and due to reach its primary completion in 2024-10-01. Interventions recorded: Capox chemotherapy. Conditions listed: Rectal Cancer; Neoadjuvant Chemotherapy. Primary outcome: pathological Tumor Regression Grade evaluation. Colorectal eligibility wording from the registry: \"Patients diagnosed with low/intermediate risk stage II/III rectal cancer under MRI and transanal ultrasound,defined as: low:T3a-bN0-1M0, EMVI (±), MRF (-) (≥2mm); Middle-high rectal cancer: T3a-cN0-1M0, EMVI (±), MRF (-) (≥2mm); No more than 3 lymph nodes with short diameter over 8mm or highly suspe\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04922853","url":"https://clinicaltrials.gov/study/NCT04922853"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04922853","phase":"3","setting":"Comparison of the Pathological Effect Between 2 and 4 Cycles Neoadjuvant CAPOX for Low/Intermediate Risk II/III Rectal Cancer：a Prospective, Non-inferior, Randomized, Controlled Trial","sponsor":"West China Hospital","started":"2021-08-26","startedType":"actual","enrolled":554,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04087421","kind":"trial","name":"Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by University of Aarhus, now recruiting.","summary":"Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome is a phase 3, randomised interventional study registered as NCT04087421 by University of Aarhus, with a registry enrolment figure of 114 participants, started 2019-09-17 and due to reach its primary completion in 2026-12. Interventions recorded: Qufora Irrisedo Cone System; Glycerol \"OBA\". Conditions listed: Low Anterior Resection Syndrome; Rectal Cancer. Primary outcome: Bowel function, change in symptom 1 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.. Colorectal eligibility wording from the registry: \"* Patients electively treated for rectal cancer with a low anterior resection\". Sites: Denmark. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04087421","url":"https://clinicaltrials.gov/study/NCT04087421"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04087421","phase":"3","setting":"Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial","sponsor":"University of Aarhus","started":"2019-09-17","startedType":"actual","enrolled":114,"enrolledBasis":"registry","outcomes":[]},{"id":"compassion-16","kind":"trial","name":"COMPASSION-16 / AK104-303","aka":[],"tldr":"A two-headed antibody that blocks two immune brakes at once extended survival in advanced cervical cancer regardless of PD-L1 status.","summary":"COMPASSION-16, also AK104-303, trial NCT04982237 sponsored by Akeso and published in the Lancet in 2024, showed that cadonilimab, a two-headed antibody that blocks PD-1 and CTLA-4 at once, added to first-line platinum and paclitaxel with or without bevacizumab extends survival in persistent, recurrent or metastatic cervical cancer in China regardless of PD-L1 status. It randomised 445 patients and met its primary progression-free and overall survival endpoints with benefit in both PD-L1-positive and PD-L1-negative subgroups, leading to NMPA approval of the first-line combination in 2024. OnCo links it to cervical cancer, bispecific antibodies, PD-1 and CTLA-4 as targets, cadonilimab, bevacizumab and Akeso. It was not approved outside China by 2026, and whether a bispecific offers more than PD-1 blockade alone in PD-L1-negative disease is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04982237","url":"https://clinicaltrials.gov/study/NCT04982237"},{"label":"Lancet 2024","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02135-4/abstract"}],"tags":[],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["bispecific-antibody"],"targets":["pd1","ctla4"],"drugs":["cadonilimab","bevacizumab","cisplatin","paclitaxel"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04982237","phase":"3","setting":"Persistent, recurrent, or metastatic cervical cancer, first line (China): cadonilimab (PD-1×CTLA-4 bispecific) + platinum-paclitaxel ± bevacizumab vs placebo + chemotherapy ± bevacizumab","sponsor":"Akeso","result":"OS HR 0.64; PFS HR 0.62.","started":"2021-08-27","startedType":"actual","yearReported":2024,"enrolled":445,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"HR","arms":[{"name":"Cadonilimab + chemo ± bev","n":222},{"name":"Placebo + chemo ± bev","n":223}],"hr":0.62,"ci":[0.49,0.8],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02135-4/abstract"},{"endpoint":"Overall survival","primary":true,"unit":"HR","arms":[{"name":"Cadonilimab + chemo ± bev"},{"name":"Placebo + chemo ± bev"}],"hr":0.64,"ci":[0.48,0.86],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02135-4/abstract"}]},{"id":"compete","kind":"trial","name":"COMPETE","aka":[],"tldr":"The first head-to-head trial of a radioligand against a targeted pill in neuroendocrine tumours; the radioligand won on progression-free survival.","summary":"COMPETE, trial NCT03049189 sponsored by ITM Isotope Technologies Munich and published in the Lancet in 2025, was the first head-to-head trial of a radioligand against a targeted tablet in neuroendocrine tumours, and the radioligand won on progression-free survival. It randomised 309 patients with progressive grade 1 to 2 somatostatin-receptor-positive gastroenteropancreatic tumours to 177Lu-edotreotide or everolimus, met its primary progression-free survival endpoint with a significantly higher response rate, and showed an interim overall survival trend that was not significant; the result supports an FDA filing with a PDUFA date of 28 August 2026. OnCo links it to peptide receptor radionuclide therapy, somatostatin receptor 2, 177Lu-edotreotide, everolimus and Jonathan R. Strosberg. Whether a second lutetium agent differentiates from lutetium dotatate is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03049189","url":"https://clinicaltrials.gov/study/NCT03049189"},{"label":"CancerNetwork: COMPETE","url":"https://www.cancernetwork.com/view/itm-11-demonstrates-superior-pfs-vs-everolimus-in-sstr-gep-nets"}],"tags":[],"related":["src-cancer-network"],"cancers":["neuroendocrine","pancreatic-net","small-intestinal-net"],"sections":[],"technologies":["prrt"],"targets":["sstr2"],"drugs":["itm-11","everolimus"],"companies":["itm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jonathan-strosberg"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03049189","phase":"3","setting":"Progressive grade 1-2 SSTR-positive GEP-NETs: 177Lu-edotreotide vs everolimus","sponsor":"ITM Isotope Technologies Munich","result":"PFS 23.9 vs 14.1 months, HR 0.67.","started":"2017-02-02","startedType":"actual","yearReported":2025,"enrolled":324,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"177Lu-edotreotide","n":207,"value":23.9},{"name":"Everolimus","n":102,"value":14.1}],"hr":0.67,"ci":[0.48,0.95],"p":"0.022","source":"https://doi.org/10.1016/S0140-6736(26)00604-5"},{"endpoint":"Overall survival (interim)","unit":"months","arms":[{"name":"177Lu-edotreotide","value":63.4},{"name":"Everolimus","value":58.7}],"hr":0.78,"ci":[0.5,1.1],"p":"0.206","source":"https://doi.org/10.1016/S0140-6736(26)00604-5"}]},{"id":"concur","kind":"trial","name":"CONCUR","aka":[],"tldr":"The Asian repeat of CORRECT found a larger benefit, partly because fewer patients had already had targeted drugs.","summary":"CONCUR randomised 204 patients in mainland China, Hong Kong, South Korea, Taiwan and Vietnam 2:1 to regorafenib or placebo. Median overall survival was 8.8 against 6.3 months (hazard ratio 0.55, 95% CI 0.40 to 0.77, one-sided p=0.00016). Drug-related adverse events occurred in 97 percent of regorafenib recipients, with grade 3 or higher hand-foot skin reaction in 16 percent and hypertension in 11 percent. Fewer patients had received prior targeted therapy than in CORRECT, which may explain the larger effect, and the trial is why regorafenib carries a strong recommendation in Asian guidelines.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01584830","url":"https://clinicaltrials.gov/study/NCT01584830"},{"label":"CONCUR: regorafenib in Asian patients with previously treated metastatic colorectal cancer (Lancet Oncology 2015)","url":"https://doi.org/10.1016/S1470-2045(15)70156-7"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["kinase-inhibitors","antiangiogenic"],"targets":["vegf"],"drugs":["regorafenib"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":["correct"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01584830","phase":"3","setting":"Asian patients with refractory metastatic colorectal cancer after at least two previous lines: regorafenib against placebo","sponsor":"Bayer","result":"Median overall survival 8.8 against 6.3 months (hazard ratio 0.55).","started":"2012-04","yearReported":2015,"enrolled":204,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Regorafenib","n":136,"value":8.8},{"name":"Placebo","n":68,"value":6.3}],"hr":0.55,"ci":[0.4,0.77],"p":"0.00016 one-sided","source":"https://doi.org/10.1016/S1470-2045(15)70156-7"}],"replication":"Confirms CORRECT in a different population."},{"id":"nct04275986","kind":"trial","name":"Concurrent Chemoradiotherapy After Endoscopic Resection for Stage I Esophageal Carcinoma","aka":[],"tldr":"A phase 2 trial of Endoscopic resection in Oesophageal squamous cell carcinoma, run by Chinese Academy of Medical Sciences, with a status the registry has not verified recently.","summary":"Concurrent Chemoradiotherapy After Endoscopic Resection for Stage I Esophageal Carcinoma is a phase 2 interventional study registered as NCT04275986 by Chinese Academy of Medical Sciences, with 56 participants planned, started 2020-01-20 and due to reach its primary completion in 2024-01. Interventions recorded: Intensity modulated radiotherapy (IMRT), Chemotherapy. Conditions recorded: Esophageal Squamous Cell Carcinoma.\n\nLinked to the technology Endoscopic resection because the registry's title names it (\"endoscopic resection\") and Oesophageal squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04275986","url":"https://clinicaltrials.gov/study/NCT04275986"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["oesophageal-squamous-cell-carcinoma"],"sections":[],"technologies":["endoscopic-resection"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04275986","phase":"2","setting":"A Phase II Clinical Trial of Concurrent Chemoradiotherapy After Endoscopic Resection for Stage I Esophageal Squamous Cell Carcinoma","sponsor":"Chinese Academy of Medical Sciences","started":"2020-01-20","startedType":"actual","enrolled":56,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06470451","kind":"trial","name":"Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL","aka":[],"tldr":"A phase 3 trial of Synthetic hypericin in Cutaneous T-cell lymphoma and Peripheral T-cell lymphomas, run by Soligenix, recorded as terminated on the registry.","summary":"Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL is a phase 3 interventional study registered as NCT06470451 by Soligenix, with 70 participants recorded, started 2025-01-07 and due to reach its primary completion in 2026-05-22. Interventions recorded: Hypericin, Placebo. Conditions recorded: CTCL/ Mycosis Fungoides, CTCL, Mycosis Fungoides, Cutaneous T Cell Lymphoma.\n\nLinked to the drug Synthetic hypericin because the registry names it among its interventions and Cutaneous T-cell lymphoma and Peripheral T-cell lymphomas among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06470451","url":"https://clinicaltrials.gov/study/NCT06470451"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cutaneous-t-cell-lymphoma","peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["hypericin-sgx301"],"companies":["soligenix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06470451","phase":"3","setting":"A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte™ (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)","sponsor":"Soligenix","started":"2025-01-07","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"conko-001","kind":"trial","name":"CONKO-001","aka":["CONKO 001","CONKO-1"],"tldr":"CONKO-001 was the trial that made chemotherapy after pancreatic cancer surgery routine: six months of gemcitabine doubled the time before the cancer came back and roughly doubled the share of patients alive at five years, from 10 to 21 percent.","summary":"CONKO-001 was a German and Austrian open-label phase 3 trial that randomised 368 patients with macroscopically complete resection of pancreatic cancer to six cycles of adjuvant gemcitabine or observation between 1998 and 2004. The primary endpoint was disease-free survival.\n\nAt a median follow-up of 136 months, median disease-free survival was 13.4 months with gemcitabine against 6.7 months with observation (hazard ratio 0.55), and overall survival was longer (hazard ratio 0.76), with five-year survival of 20.7 against 10.4 percent and ten-year survival of 12.2 against 7.7 percent. Gemcitabine alone remains the adjuvant option for patients who cannot tolerate combination chemotherapy, which is how the corpus's resectable pancreatic cancer page cites the trial. It is registered only with the ISRCTN registry.","status":"positive","asOf":"2026-09-22","links":[{"label":"ISRCTN34802808","url":"https://www.isrctn.com/ISRCTN34802808"}],"tags":["soc-trials"],"related":[],"cancers":["resectable-pdac","pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":["charite"],"pathways":[],"terms":["pancreatic-cancer-uk-drug-access"],"trials":["espac-4","prodige-24","jaspac-01"],"people":[],"bottlenecks":[],"keyPapers":["paper-conko-001-adjuvant-gemcitabine-long-term-oettle-jama-2013"],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN34802808","phase":"3","setting":"Macroscopically complete resection of pancreatic cancer in Germany and Austria: six months of adjuvant gemcitabine against observation, with disease-free survival as the primary endpoint","sponsor":"Charite University, Berlin, Germany","result":"Median disease-free survival 13.4 months with adjuvant gemcitabine against 6.7 months with observation (hazard ratio 0.55); five-year overall survival 20.7 against 10.4 percent (hazard ratio 0.76, p 0.01).","yearReported":2013,"enrolled":368,"enrolledBasis":"randomised","enrolledNote":"CONKO-001 has no ClinicalTrials.gov record; the figure is the 368 randomised in the JAMA report (354 in the intention-to-treat analysis); the trial is registered as ISRCTN34802808.","outcomes":[{"endpoint":"Disease-free survival","primary":true,"unit":"months","arms":[{"name":"Adjuvant gemcitabine","value":13.4,"note":"95% CI 11.6 to 15.3; 354 patients in the intention-to-treat analysis"},{"name":"Observation","value":6.7,"note":"95% CI 6.0 to 7.5"}],"hr":0.55,"ci":[0.44,0.69],"p":"<0.001","source":"https://doi.org/10.1001/jama.2013.279201"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Adjuvant gemcitabine","value":20.7,"note":"95% CI 14.7 to 26.6"},{"name":"Observation","value":10.4,"note":"95% CI 5.9 to 15.0"}],"hr":0.76,"ci":[0.61,0.95],"p":"0.01","source":"https://doi.org/10.1001/jama.2013.279201"},{"endpoint":"Overall survival at 10 years","unit":"%","arms":[{"name":"Adjuvant gemcitabine","value":12.2,"note":"95% CI 7.3 to 17.2"},{"name":"Observation","value":7.7,"note":"95% CI 3.6 to 11.8"}],"source":"https://doi.org/10.1001/jama.2013.279201"}]},{"id":"conko-003","kind":"trial","name":"CONKO-003 (OFF)","aka":["CONKO 003","OFF regimen trial","Oxaliplatin, folinic acid and fluorouracil second line"],"tldr":"CONKO-003 was the first randomised trial to show a second-line chemotherapy helps in pancreatic cancer: adding oxaliplatin to fluorouracil after gemcitabine failed lengthened median survival from 3.3 to 5.9 months, which is why oxaliplatin-based second-line treatment is in the NICE guideline. A later Canadian trial with a different oxaliplatin schedule found the opposite.","summary":"CONKO-003 randomised 168 patients whose disease had progressed on gemcitabine monotherapy to OFF (oxaliplatin 85 mg/m2 on days 8 and 22 with folinic acid and 24-hour fluorouracil on days 1, 8, 15 and 22 of a 42-day cycle) or FF alone, stratified by metastases, duration of first-line therapy and Karnofsky status. With a median follow-up of 54.1 months, median overall survival was 5.9 months (95 percent confidence interval 4.1 to 7.4) with OFF against 3.3 months (2.7 to 4.0) with FF (hazard ratio 0.66, 0.48 to 0.91; p 0.010) and time to progression 2.9 against 2.0 months (hazard ratio 0.68); adverse events were similar apart from grade 1 to 2 neurotoxicity (38.2 against 7.1 percent). PANCREOX (108 Canadian patients, 2016) then found modified FOLFOX6 no better for progression-free survival and worse for overall survival than infusional fluorouracil and leucovorin (6.1 against 9.9 months; p 0.02) with grade 3 to 4 events in 63 against 11 percent, so the oxaliplatin schedule matters. NICE NG85 recommends oxaliplatin-based second-line chemotherapy for people who have not had first-line oxaliplatin (1.9.7) and gemcitabine-based treatment after first-line FOLFIRINOX (1.9.8); daraxonrasib (RASolute 302) now supersedes both where it is available.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00786058","url":"https://clinicaltrials.gov/study/NCT00786058"},{"label":"Oettle et al., CONKO-003 (JCO 2014)","url":"https://doi.org/10.1200/JCO.2013.53.6995"},{"label":"Gill et al., PANCREOX (JCO 2016)","url":"https://doi.org/10.1200/JCO.2016.68.5776"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac","locally-advanced-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["oxaliplatin","fluorouracil","leucovorin","folfox"],"companies":[],"institutions":["charite"],"pathways":[],"terms":["peripheral-neuropathy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00786058","phase":"3","setting":"Advanced pancreatic cancer progressing during first-line gemcitabine in Germany: oxaliplatin with folinic acid and fluorouracil (OFF) against folinic acid and fluorouracil (FF), with overall survival as the primary endpoint","sponsor":"Charite University Medicine Berlin (CONKO study group)","result":"Median overall survival 5.9 months with OFF against 3.3 months with FF (hazard ratio 0.66, 95 percent confidence interval 0.48 to 0.91; p 0.010); time to progression 2.9 against 2.0 months.","yearReported":2014,"enrolled":168,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov NCT00786058 gives no enrolment figure in the summary record read on 24 September 2026; 168 patients were randomised at 16 German institutions between January 2004 and May 2007 and 160 were eligible for the primary analysis.","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"OFF (oxaliplatin, folinic acid, fluorouracil)","value":5.9,"note":"95% CI 4.1 to 7.4; 160 patients in the primary analysis"},{"name":"FF (folinic acid, fluorouracil)","value":3.3,"note":"95% CI 2.7 to 4.0"}],"hr":0.66,"ci":[0.48,0.91],"p":"0.010","source":"https://doi.org/10.1200/JCO.2013.53.6995"}]},{"id":"conko-005","kind":"trial","name":"CONKO-005","aka":["CONKO 005"],"tldr":"CONKO-005 was the first adjuvant trial to add a targeted drug to chemotherapy after pancreatic surgery; six months of erlotinib with gemcitabine made no difference to the time before relapse (11.4 months in both arms) or to survival.","summary":"CONKO-005 randomised 436 patients after R0 resection to gemcitabine 1,000 mg/m2 on days 1, 8 and 15 every four weeks with or without erlotinib 100 mg once daily for six cycles, aiming to lift median disease-free survival from 14 to 18 months. After a median follow-up of 54 months and 361 recurrences, median disease-free survival was 11.4 months in both arms and median overall survival 24.5 months with erlotinib against 26.5 months without; estimated survival at one, two and five years was 77, 53 and 25 percent against 79, 54 and 20 percent, and rash did not predict benefit. Together with the erlotinib arms of LAP07 and RTOG 0848 step 1 it closed the EGFR question in pancreatic cancer outside the licensed metastatic indication.","status":"negative","asOf":"2026-09-24","links":[{"label":"Sinn et al., CONKO-005 (JCO 2017)","url":"https://doi.org/10.1200/JCO.2017.72.6463"},{"label":"Abrams et al., RTOG 0848 step 1: adjuvant erlotinib plus gemcitabine (Am J Clin Oncol 2020)","url":"https://doi.org/10.1097/COC.0000000000000633"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors"],"targets":["egfr"],"drugs":["erlotinib","gemcitabine"],"companies":[],"institutions":["charite"],"pathways":[],"terms":["pancreatic-failed-programmes"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"R0-resected pancreatic ductal adenocarcinoma in Germany: six cycles of adjuvant gemcitabine with or without erlotinib 100 mg daily, with disease-free survival as the primary endpoint","sponsor":"Charite University Medicine Berlin (CONKO study group)","result":"Median disease-free survival 11.4 months with gemcitabine plus erlotinib and 11.4 months with gemcitabine; median overall survival 24.5 against 26.5 months.","yearReported":2017,"enrolled":436,"enrolledBasis":"randomised","enrolledNote":"No ClinicalTrials.gov record for CONKO-005 was returned by the v2 API term search on 24 September 2026; 436 patients were randomised at 57 German centres between April 2008 and July 2013 according to the JCO 2017 report.","outcomes":[{"endpoint":"Disease-free survival","primary":true,"unit":"months","arms":[{"name":"Adjuvant gemcitabine + erlotinib","value":11.4},{"name":"Adjuvant gemcitabine","value":11.4}],"source":"https://doi.org/10.1200/JCO.2017.72.6463"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Adjuvant gemcitabine + erlotinib","value":24.5},{"name":"Adjuvant gemcitabine","value":26.5}],"source":"https://doi.org/10.1200/JCO.2017.72.6463"}]},{"id":"conko-007","kind":"trial","name":"CONKO-007","aka":["CONKO 007"],"tldr":"CONKO-007 is the largest test of radiotherapy after chemotherapy for pancreatic cancer that cannot be removed at diagnosis: chemoradiotherapy did not raise the share of all patients reaching a clear-margin operation (25 against 18 percent) or lengthen survival, but among those operated the margins were clear more often (69 against 50 percent).","summary":"CONKO-007 enrolled 525 patients with unresectable tumours; after three months of induction 336 were randomised to continue the same chemotherapy (167) or to chemoradiotherapy (169). Slow recruitment led the investigators to change the primary endpoint from overall survival to the overall R0 resection rate after an interim analysis; median follow-up was 76 months. R0 resection was achieved in 25 percent (43 of 169) after chemoradiotherapy against 18 percent (30 of 167) after chemotherapy (p 0.113), not significant; surgery was performed equally often and among operated patients the R0 rate was 69.4 against 50.0 percent (p 0.04), with the R0/R1/R2/no-resection distribution also favouring chemoradiotherapy (p 0.02). Overall survival did not differ (hazard ratio 0.937, 95 percent confidence interval 0.747 to 1.174; p 0.57) while surgery itself was associated with longer survival (hazard ratio 0.525). Letters in JCO 2026 debated the endpoint change and the gemcitabine radiosensitiser; the corpus reads it with LAP07 (no survival gain, better local control) and SCALOP (capecitabine as the preferred radiosensitiser).","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01827553","url":"https://clinicaltrials.gov/study/NCT01827553"},{"label":"Fietkau et al., CONKO-007 (JCO 2025)","url":"https://doi.org/10.1200/JCO-24-01502"}],"tags":[],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":["chemoradiation","imrt-igrt","cytotoxic-chemotherapy"],"targets":[],"drugs":["folfirinox","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":["chemoradiation","resection-margins","resectability","pancreatic-failed-programmes"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01827553","phase":"3","setting":"Unresectable locally advanced pancreatic cancer in Germany: three months of induction chemotherapy (FOLFIRINOX in 402, gemcitabine in 93), then randomisation of patients without progression to continued chemotherapy or chemoradiotherapy (50.4 Gy with gemcitabine), with resectability reassessed by a central surgical panel; the primary endpoint was changed from overall survival to the overall R0 resection rate","sponsor":"University of Erlangen-Nuremberg (CONKO study group)","result":"Overall R0 resection rate 25 percent with chemoradiotherapy against 18 percent with chemotherapy (p 0.113); R0 among operated patients 69.4 against 50.0 percent (p 0.04); overall survival hazard ratio 0.937 (p 0.57).","started":"2013-04-04","startedType":"actual","yearReported":2025,"enrolled":336,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov NCT01827553 lists an estimated 830 participants; 525 patients were enrolled, 495 received induction chemotherapy and 336 without progression after three months were randomised according to the JCO 2025 report.","outcomes":[{"endpoint":"R0 resection rate, all randomised patients","primary":true,"unit":"%","arms":[{"name":"Induction chemotherapy then chemoradiotherapy","n":169,"value":25,"note":"43 of 169"},{"name":"Continued chemotherapy","n":167,"value":18,"note":"30 of 167"}],"p":"0.113","source":"https://doi.org/10.1200/JCO-24-01502"},{"endpoint":"Overall survival (randomised intention to treat)","unit":"months","arms":[{"name":"Induction chemotherapy then chemoradiotherapy","n":169,"note":"Medians not given in the abstract"},{"name":"Continued chemotherapy","n":167}],"hr":0.937,"ci":[0.747,1.174],"p":"0.57","source":"https://doi.org/10.1200/JCO-24-01502"}]},{"id":"nct02843191","kind":"trial","name":"Consolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy","aka":["KONCLUDE"],"tldr":"A phase 3 trial in colorectal cancer, run by Kyung Hee University Hospital at Gangdong, active but no longer recruiting.","summary":"Consolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy is a phase 3, randomised interventional study registered as NCT02843191 by Kyung Hee University Hospital at Gangdong, with a registry enrolment figure of 358 participants, started 2016-12-07 and due to reach its primary completion in 2023-07-15. Interventions recorded: Chemotherapy. Conditions listed: Rectal Cancer. Primary outcome: Pathologic complete response; Disease-free survival. Colorectal eligibility wording from the registry: \"Histologically confirmed adenocarcinoma of mid or low rectum\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02843191","url":"https://clinicaltrials.gov/study/NCT02843191"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02843191","phase":"3","setting":"KCSP Trial of CONsolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After NeoadjUvant Concurrent ChemoraDiothErapy: a Multicenter, Randomized Controlled Trial (KONCLUDE)","sponsor":"Kyung Hee University Hospital at Gangdong","started":"2016-12-07","startedType":"actual","enrolled":358,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06500273","kind":"trial","name":"Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL","aka":["ALPHA3"],"tldr":"A phase 2 trial of Fludarabine and Cyclophosphamide in diffuse large B-cell lymphoma, run by Allogene Therapeutics, now recruiting.","summary":"Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL is a phase 2 interventional study registered as NCT06500273 by Allogene Therapeutics, with 250 participants planned, started 2024-06-18 and due to reach its primary completion in 2027-12. Interventions recorded: cemacabtagene ansegedleucel, Fludarabine, Cyclophosphamide and Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06500273","url":"https://clinicaltrials.gov/study/NCT06500273"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["fludarabine","cyclophosphamide"],"companies":["allogene","foresight-diagnostics","natera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06500273","phase":"2","setting":"A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma","sponsor":"Allogene Therapeutics","started":"2024-06-18","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06502080","kind":"trial","name":"Consolidative Radiotherapy (CSRT) in Patients With Oligometastatic/Locally Advanced Unresectable Bilary Tract Cancer (BTC)","aka":["RADITOP"],"tldr":"A phase 2 trial of durvalumab, pembrolizumab, sintilimab and other drugs with radiotherapy in gallbladder cancer and other biliary tract cancers, run by Shanghai Zhongshan Hospital, not yet recruiting.","summary":"Consolidative Radiotherapy (CSRT) in Patients With Oligometastatic/Locally Advanced Unresectable Bilary Tract Cancer (BTC) is a phase 2, randomised interventional study registered as NCT06502080 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 128 participants, started 2024-07 and due to reach its primary completion in 2027-06-30. Interventions recorded: Consolidative radiotherapy, Standard-of-care systemic therapy: Gemcitabine + cisplatin/oxaliplatin + Durvalumab/Pembrolizumab/Sintilimab/Toripalimab. Conditions listed: Biliary Tract Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06502080","url":"https://clinicaltrials.gov/study/NCT06502080"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["durvalumab","pembrolizumab","sintilimab","toripalimab","gemcitabine","cisplatin","oxaliplatin"],"companies":[],"institutions":[],"pathways":[],"terms":["radiotherapy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06502080","phase":"2","setting":"Standard-of-care Systemic Therapy With or Without Consolidative Radiotherapy in Patients With Oligometastatic/Locally Advanced Unresectable Biliary Tract Cancer: an Open-label, Randomised, Controlled Study","sponsor":"Shanghai Zhongshan Hospital","started":"2024-07","startedType":"estimated","enrolled":128,"enrolledBasis":"registry","outcomes":[]},{"id":"contact-03","kind":"trial","name":"CONTACT-03","aka":[],"tldr":"Continuing immunotherapy after it has failed, alongside a targeted pill, added nothing but side effects. The first definitive test of 'IO rechallenge'.","summary":"CONTACT-03, trial NCT04338269 sponsored by Roche and Exelixis and published in the Lancet in 2023, was the first definitive test of immunotherapy rechallenge in kidney cancer, and it found that continuing PD-L1 blockade after progression on immunotherapy, alongside cabozantinib, added nothing but side effects. It randomised 522 patients with advanced renal cell carcinoma progressing on or after a PD-1 or PD-L1 inhibitor to atezolizumab plus cabozantinib or cabozantinib alone and found no difference in progression-free or overall survival with more toxicity. OnCo links it to renal cell carcinoma, atezolizumab, cabozantinib, Sumanta K. Pal, Neeraj Agarwal and a caution pairing about PD-1 rechallenge after progression. It changed practice so that rechallenge is no longer recommended, and whether any biomarker-defined subgroup might still benefit is the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04338269","url":"https://clinicaltrials.gov/study/NCT04338269"}],"tags":["lesson:io-rechallenge"],"related":[],"cancers":["rcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab","cabozantinib"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sumanta-pal","neeraj-agarwal"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04338269","phase":"3","setting":"Advanced RCC progressing on or after a PD-1/PD-L1 inhibitor: atezolizumab + cabozantinib vs cabozantinib","sponsor":"Roche / Exelixis","result":"PFS HR 1.03; OS HR 0.94, negative.","started":"2020-07-28","startedType":"actual","yearReported":2023,"enrolled":522,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Atezolizumab + cabozantinib","n":263,"value":10.6},{"name":"Cabozantinib","n":259,"value":10.8}],"hr":1.03,"ci":[0.83,1.28],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00922-4/fulltext"}],"replication":"Replicated by TiNivo-2 (2024-26): no benefit from nivolumab rechallenge with tivozanib."},{"id":"nct07389265","kind":"trial","name":"Continuation of Cetuximab Beyond First-Line Progression in Metastatic Colorectal Cancer","aka":["CAPRI-3 GOIM"],"tldr":"A phase 3 trial of cetuximab, bevacizumab (glioblastoma use), fOLFOX (5-FU, leucovorin, oxaliplatin) and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by University of Campania Luigi Vanvitelli, now recruiting.","summary":"Continuation of Cetuximab Beyond First-Line Progression in Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT07389265 by University of Campania Luigi Vanvitelli, with a registry enrolment figure of 480 participants, started 2025-10-01 and due to reach its primary completion in 2030-10. Interventions recorded: Erbitux (Cetuximab); Bevacizumab; FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin); FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan). Conditions listed: Metastatic Colorectal Cancer (mCRC). Primary outcome: Overall Response Rate (ORR). Colorectal eligibility wording from the registry: \"Histologically proven diagnosis of colorectal adenocarcinoma\". Sites: Italy, Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07389265","url":"https://clinicaltrials.gov/study/NCT07389265"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["cetuximab","bevacizumab-glioma","folfox","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07389265","phase":"3","setting":"CAPRI-3 GOIM Study: Phase 3 Clinical Study to Evaluate the Use of Continuing Cetuximab Treatment Beyond First Line Progression in Molecular Selected Metastatic Colorectal Cancer Patients.","sponsor":"University of Campania Luigi Vanvitelli","started":"2025-10-01","startedType":"actual","enrolled":480,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04842604","kind":"trial","name":"Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML","aka":[],"tldr":"A phase 3 trial of Glasdegib and Azacitidine in Acute myeloid leukaemia and Leukaemia, run by Pfizer, completed.","summary":"Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML is a phase 3 interventional study registered as NCT04842604 by Pfizer, with 14 participants recorded, started 2021-05-17 and reaching its primary completion in 2022-12-02. Interventions recorded: Glasdegib, Azacitidine. Conditions recorded: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia.\n\nLinked to the drug Glasdegib because the registry names it among its interventions and Acute myeloid leukaemia and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04842604","url":"https://clinicaltrials.gov/study/NCT04842604"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["glasdegib","azacitidine"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04842604","phase":"3","setting":"A MULTI-CENTER CONTINUATION STUDY EVALUATING AZACITIDINE WITH OR WITHOUT GLASDEGIB (PF-04449913) IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA, MYELODYSPLASTIC SYNDROME OR CHRONIC MYELOMONOCYTIC LEUKEMIA","sponsor":"Pfizer","started":"2021-05-17","startedType":"actual","enrolled":14,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05059522","kind":"trial","name":"Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing","aka":[],"tldr":"A phase 3 trial of Avelumab, Talazoparib, Pemetrexed in ovarian cancer, run by Pfizer, active and no longer recruiting.","summary":"Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing is a phase 3 interventional study registered as NCT05059522 by Pfizer, with 77 participants enrolled, started 2021-09-29 and due to reach its primary completion in 2026-12-31. Interventions recorded: Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib. Conditions listed: Advanced Malignancies, NSCLC, Ovarian Cancer, Urothelial Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05059522","url":"https://clinicaltrials.gov/study/NCT05059522"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["avelumab","talazoparib","pemetrexed","axitinib","utomilumab"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05059522","phase":"3","setting":"AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED AVELUMAB CLINICAL STUDIES.","sponsor":"Pfizer","started":"2021-09-29","startedType":"actual","enrolled":77,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07004413","kind":"trial","name":"Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type mCRC Patients","aka":["FIRE-11"],"tldr":"A phase 3 trial in colorectal cancer, run by Charite University, Berlin, Germany, not yet recruiting.","summary":"Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type mCRC Patients is a phase 3, randomised interventional study registered as NCT07004413 by Charite University, Berlin, Germany, with a registry enrolment figure of 267 participants, started 2026-10-01 and due to reach its primary completion in 2028-10-01. Interventions recorded: FOLFIRI+cetuximab; Guardant360 ctDNA assay. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Progression-free survival (PFS) on treatment rate at 12 months. Colorectal eligibility wording from the registry: \"Histologically confirmed, UICC stage IV unresectable adenocarcinoma of the colon or rectum\". Sites: Germany. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07004413","url":"https://clinicaltrials.gov/study/NCT07004413"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":["guardant-health","merck-kgaa"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07004413","phase":"3","setting":"Randomized Study to Compare First-line Treatment With Either Continuous or Intermittent Cetuximab Plus FOLFIRI in Patients With RAS/BRAF-wild-type Metastatic Colorectal Cancer (mCRC): AIO-KRK-0524 / FIRE-11","sponsor":"Charite University, Berlin, Germany","started":"2026-10-01","startedType":"estimated","enrolled":267,"enrolledBasis":"registry","outcomes":[]},{"id":"continuum","kind":"trial","name":"CONTINUUM","aka":["2018-FXY-135-FLK"],"tldr":"CONTINUUM was the first trial to show that adding a PD-1 immunotherapy, sintilimab, to the chemotherapy and radiotherapy given for advanced but not yet metastatic nasopharyngeal cancer keeps more people free of relapse three years later, 86 against 76 percent, at the cost of more side effects.","summary":"CONTINUUM was an open-label randomised phase 3 trial at nine hospitals in China that randomised 425 adults with high-risk locoregionally advanced nasopharyngeal carcinoma to standard gemcitabine-cisplatin induction followed by concurrent cisplatin radiotherapy, with or without sintilimab 200 mg every three weeks for 12 cycles spanning induction, concurrent and adjuvant phases. The primary endpoint was event-free survival.\n\nAt a median follow-up of 41.9 months, three-year event-free survival was 86 percent with sintilimab against 76 percent without (hazard ratio 0.59). Grade 3 to 4 adverse events were 74 against 65 percent, grade 3 to 4 immune-related events occurred in 10 percent of the sintilimab group and two immune-related deaths occurred. The corpus's locoregionally advanced nasopharyngeal carcinoma page cites CONTINUUM for adding a PD-1 antibody to chemoradiotherapy, with toripalimab and camrelizumab in parallel trials.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03700476","url":"https://clinicaltrials.gov/study/NCT03700476"}],"tags":["soc-trials"],"related":[],"cancers":["locoregionally-advanced-nasopharyngeal-carcinoma","nasopharyngeal"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt","cytotoxic-chemotherapy"],"targets":[],"drugs":["sintilimab","gemcitabine","cisplatin"],"companies":["innovent"],"institutions":["sysucc"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-continuum-sintilimab-nasopharyngeal-liu-lancet-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03700476","phase":"3","setting":"High-risk locoregionally advanced nasopharyngeal carcinoma (stage III to IVa, excluding T3-4N0 and T3N1) in adults aged 18 to 65 at nine Chinese hospitals: gemcitabine-cisplatin induction and concurrent cisplatin radiotherapy with or without 12 cycles of the PD-1 antibody sintilimab, with event-free survival as the primary endpoint","sponsor":"Sun Yat-sen University Cancer Center","result":"Three-year event-free survival 86 percent with sintilimab added to chemoradiotherapy against 76 percent without (hazard ratio 0.59, p 0.019); grade 3 to 4 adverse events 74 against 65 percent.","started":"2018-12-21","startedType":"actual","yearReported":2024,"enrolled":425,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Sintilimab + induction chemotherapy + concurrent chemoradiotherapy","n":210,"value":86,"note":"95% CI 81 to 90; median follow-up 41.9 months"},{"name":"Induction chemotherapy + concurrent chemoradiotherapy","n":215,"value":76,"note":"95% CI 70 to 81"}],"hr":0.59,"ci":[0.38,0.92],"p":"0.019","source":"https://doi.org/10.1016/S0140-6736(24)00594-4"},{"endpoint":"Grade 3 to 4 adverse events","unit":"%","arms":[{"name":"Sintilimab + chemoradiotherapy","n":210,"value":74},{"name":"Chemoradiotherapy","n":215,"value":65}],"source":"https://doi.org/10.1016/S0140-6736(24)00594-4"},{"endpoint":"Grade 3 to 4 immune-related adverse events","unit":"%","arms":[{"name":"Sintilimab + chemoradiotherapy","n":210,"value":10,"note":"20 patients; 2 immune-related deaths"}],"source":"https://doi.org/10.1016/S0140-6736(24)00594-4"}]},{"id":"nct06311695","kind":"trial","name":"Contrast-Enhanced Spectral Mammography (CESM)","aka":[],"tldr":"A phase 2 trial of Contrast-enhanced mammography in Breast cancer, run by European Institute of Oncology, with a status the registry has not verified recently.","summary":"Contrast-Enhanced Spectral Mammography (CESM) is a phase 2 interventional study registered as NCT06311695 by European Institute of Oncology, with 263 participants planned, started 2020-11-16 and due to reach its primary completion in 2025-02-28. Interventions recorded: Contrast Enhanced Mammography. Conditions recorded: Breast Cancer.\n\nLinked to the technology Contrast-enhanced mammography because the registry names it (\"contrast enhanced mammography\") among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06311695","url":"https://clinicaltrials.gov/study/NCT06311695"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["contrast-enhanced-mammography"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06311695","phase":"2","setting":"The Role of Contrast-Enhanced Spectral Mammography (CESM) in the Diagnostic Process of Breast Cancer","sponsor":"European Institute of Oncology","started":"2020-11-16","startedType":"actual","enrolled":263,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03777982","kind":"trial","name":"Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT","aka":[],"tldr":"A phase 3 trial of Prednisone and Apalutamide and Abiraterone acetate in Prostate cancer, run by Dana-Farber Cancer Institute, recorded as terminated on the registry.","summary":"Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT is a phase 3 interventional study registered as NCT03777982 by Dana-Farber Cancer Institute, with 12 participants recorded, started 2020-04-20 and due to reach its primary completion in 2024-02-13. Interventions recorded: Prednisone, Apalutamide, Abiraterone Acetate, LHRH Agonist or Antagonist. Conditions recorded: Prostate Cancer.\n\nLinked to the idea \"Prescribe a quarter dose of abiraterone with breakfast\" because the registry names Prednisone and Apalutamide and Abiraterone acetate among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03777982","url":"https://clinicaltrials.gov/study/NCT03777982"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["prednisone","apalutamide","abiraterone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03777982","phase":"3","setting":"A Randomized Phase III Study - Conventional Androgen Deprivation Therapy With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and Androgen Deprivation Therapy","sponsor":"Dana-Farber Cancer Institute","started":"2020-04-20","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03401294","kind":"trial","name":"Conversion From Unresectable To Resectable Metastatic Colorectal Cancer.","aka":["CONVERSION"],"tldr":"A phase 2 trial in colorectal cancer, run by University of Saskatchewan, now recruiting.","summary":"Conversion From Unresectable To Resectable Metastatic Colorectal Cancer. is a phase 2, interventional study registered as NCT03401294 by University of Saskatchewan, with a registry enrolment figure of 32 participants, started 2025-05-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: FOLFOXIRI and Bevacizumab. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Rate of liver metastasectomy. Colorectal eligibility wording from the registry: \"* Adult patients, aged between 18 and 70 years with histologically proven adenocarcinoma or poorly differentiated carcinoma of the colon and rectum with unresectable liver-only metastases and no extra-hepatic disease\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03401294","url":"https://clinicaltrials.gov/study/NCT03401294"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03401294","phase":"2","setting":"Conversion From Unresectable To Resectable Liver Metastases In Patients With Liver-Only Metastatic Colorectal Cancer Treated With FOLFOXIRI Plus Bevacizumab. The Conversion Trial.","sponsor":"University of Saskatchewan","started":"2025-05-01","startedType":"actual","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06690528","kind":"trial","name":"Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver","aka":["SONAR"],"tldr":"A phase 2 trial in pancreatic cancer, run by Azienda Ospedaliera di Padova, now recruiting.","summary":"Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver is a phase 2, randomised interventional study registered as NCT06690528 by Azienda Ospedaliera di Padova, with a registry enrolment figure of 56 participants, started 2024-11-06 and due to reach its primary completion in 2028-11. Interventions recorded: Surgical resection of both the primary tumor and liver metastases. Conditions listed: Pancreatic Cancer Metastatic. Primary outcome: Two-year OS (2y-OS) rate. Pancreatic eligibility wording from the registry: \"* Cytologically or histologically confirmed pancreatic adenocarcinoma either resectable or borderline resectable (at diagnosis) according to National Comprehensive Cancer Network (NCCN)4 (see section 5)\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06690528","url":"https://clinicaltrials.gov/study/NCT06690528"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06690528","phase":"2","setting":"Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver (SONAR: Surgery in Oligometastatic PaNcreatic CAnceR) a Randomized Controlled Trial","sponsor":"Azienda Ospedaliera di Padova","started":"2024-11-06","startedType":"actual","enrolled":56,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04687631","kind":"trial","name":"Conversion Therapy of RAS/BRAF Wild-Type Colorectal Cancer Patients With Initially Unresectable Liver Metastases","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by Fudan University, now recruiting.","summary":"Conversion Therapy of RAS/BRAF Wild-Type Colorectal Cancer Patients With Initially Unresectable Liver Metastases is a phase 3, randomised interventional study registered as NCT04687631 by Fudan University, with a registry enrolment figure of 508 participants, started 2021-01-14 and due to reach its primary completion in 2025-03-31. Interventions recorded: mFOLFOXIRI plus Cetuximab; mFOLFOXIRI Plus Bevacizumab. Conditions listed: Colorectal Cancer; Liver Metastases. Primary outcome: Conversion resection rate of liver metastases. Colorectal eligibility wording from the registry: \"The primary tumor was confirmed by histology as colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04687631","url":"https://clinicaltrials.gov/study/NCT04687631"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04687631","phase":"3","setting":"Conversion Therapy of RAS/BRAF Wild-Type Colorectal Cancer Patients With Initially Unresectable Liver Metastases: mFOLFOXIRI Plus Cetuximab Versus mFOLFOXIRI Plus Bevacizumab","sponsor":"Fudan University","started":"2021-01-14","startedType":"actual","enrolled":508,"enrolledBasis":"registry","outcomes":[]},{"id":"convert","kind":"trial","name":"CONVERT","aka":[],"tldr":"Settled the radiotherapy schedule debate in limited-stage disease: neither schedule was superior, so twice-daily 45 Gy remains standard and once-daily is an acceptable alternative.","summary":"CONVERT, trial NCT00433563 sponsored by Cancer Research UK and the EORTC and reported in 2017, settled the radiotherapy schedule debate in limited-stage small-cell lung cancer: neither schedule was superior, so twice-daily 45 Gy remains standard and once-daily 66 Gy is an acceptable alternative. It randomised 547 patients to twice-daily or once-daily thoracic radiotherapy with concurrent cisplatin and etoposide, was designed to show superiority of the once-daily schedule and did not, with similar toxicity and both arms outperforming historical controls. OnCo links it to small-cell lung cancer, modern external beam radiotherapy, the limited-stage term and Corinne Faivre-Finn. Because it was not a non-inferiority design, whether once-daily treatment is truly equivalent rather than merely not proven superior is the open question.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00433563","url":"https://clinicaltrials.gov/study/NCT00433563"}],"tags":[],"related":[],"cancers":["sclc","limited-stage-sclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["curie-nki-eortc"],"institutions":["the-christie"],"pathways":[],"terms":["limited-extensive-stage"],"trials":["chart-lung"],"people":["corinne-faivre-finn"],"bottlenecks":[],"keyPapers":["paper-convert-lancet-oncol-2017","paper-convert-int-j-radiat-oncol-biol-phys-2024-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00433563","phase":"3","setting":"Limited-stage SCLC: twice-daily 45 Gy vs once-daily 66 Gy thoracic radiotherapy with concurrent cisplatin-etoposide","sponsor":"Cancer Research UK / EORTC","result":"No significant difference; twice-daily 45 Gy remains standard.","started":"2008-04","yearReported":2017,"enrolled":547,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Twice-daily 45 Gy","n":274,"value":30},{"name":"Once-daily 66 Gy","n":273,"value":25}],"hr":1.18,"ci":[0.95,1.45],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30318-2/fulltext"}]},{"id":"nct06235151","kind":"trial","name":"Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Copper Cu 64 PSMA I&T in prostate cancer, run by Curium US LLC, active and no longer recruiting.","summary":"Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer is a phase 3 interventional study registered as NCT06235151 by Curium US LLC, with 439 participants enrolled, started 2024-04-01 and due to reach its primary completion in 2026-09. Interventions recorded: Copper Cu 64 PSMA I&T.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06235151","url":"https://clinicaltrials.gov/study/NCT06235151"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["curium"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06235151","phase":"3","setting":"Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging Men With Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy With Pelvic Lymph Node Dissection","sponsor":"Curium US LLC","started":"2024-04-01","startedType":"actual","enrolled":439,"enrolledBasis":"registry","outcomes":[]},{"id":"correct","kind":"trial","name":"CORRECT","aka":[],"tldr":"The first pill to lengthen life in bowel cancer after everything else has failed. The gain was six weeks and the hand and foot rash was severe in one patient in six.","summary":"CORRECT randomised 760 patients at 114 centres in 16 countries 2:1 to regorafenib or placebo, each with best supportive care, after progression on or within three months of the last standard therapy. Median overall survival was 6.4 against 5.0 months (hazard ratio 0.77, 95% CI 0.64 to 0.94, one-sided p=0.0052) and the primary endpoint was met at a preplanned interim analysis. Treatment-related adverse events affected 93 percent of the regorafenib group; grade 3 or higher hand-foot skin reaction occurred in 17 percent, fatigue in 10 percent, and diarrhoea and hypertension in 7 percent each. The FDA approved regorafenib for colorectal cancer in September 2012 and the EU marketing authorisation for Stivarga followed on 26 August 2013; NICE recommended it in England only in February 2023 (TA866), a decade later.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01103323","url":"https://clinicaltrials.gov/study/NCT01103323"},{"label":"CORRECT: regorafenib monotherapy for previously treated metastatic colorectal cancer (Lancet 2013)","url":"https://doi.org/10.1016/S0140-6736(12)61900-X"},{"label":"NICE TA866: regorafenib for previously treated metastatic colorectal cancer","url":"https://www.nice.org.uk/guidance/ta866"},{"label":"EMA Stivarga","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/stivarga"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["kinase-inhibitors","antiangiogenic"],"targets":["vegf","braf"],"drugs":["regorafenib"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":["concur"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01103323","phase":"3","setting":"Metastatic colorectal cancer progressing after all approved standard therapies: regorafenib 160 mg daily, three weeks on and one off, with best supportive care, against placebo","sponsor":"Bayer","result":"Median overall survival 6.4 against 5.0 months (hazard ratio 0.77); grade 3 or worse hand-foot skin reaction in 17 percent.","started":"2010-04","yearReported":2013,"enrolled":760,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Regorafenib plus best supportive care","n":505,"value":6.4},{"name":"Placebo plus best supportive care","n":255,"value":5}],"hr":0.77,"ci":[0.64,0.94],"p":"0.0052 one-sided","source":"https://doi.org/10.1016/S0140-6736(12)61900-X"}],"replication":"CONCUR replicated the survival benefit in Asian patients (8.8 against 6.3 months, hazard ratio 0.55)."},{"id":"nct07398339","kind":"trial","name":"Cosiporfin Sodium for Injection Photodynamic Therapy","aka":["DVDMS"],"tldr":"A phase 2 trial of Gemcitabine and Cisplatin in biliary tract cancer, run by Shanghai Guangsheng Biopharmaceutical Co., Ltd, now recruiting.","summary":"Cosiporfin Sodium for Injection Photodynamic Therapy is a phase 2 interventional study registered as NCT07398339 by Shanghai Guangsheng Biopharmaceutical Co., Ltd, with 30 participants planned, started 2026-03-31 and due to reach its primary completion in 2027-03-31. Interventions recorded: Cosiporfin Sodium for injection, DVDMS, Gemcitabine Hydrochloride for Injection and Cisplatin for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07398339","url":"https://clinicaltrials.gov/study/NCT07398339"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma","extrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07398339","phase":"2","setting":"A Multicenter, Open-Label, Phase IIa Clinical Study Evaluating the Preliminary Efficacy and Safety of Sodium Porphyrin Injection Combined With Photodynamic Therapy Plus Gemcitabine and Cisplatin Chemotherapy in Patients With Advanced Extrahepatic Cholangiocarcinoma With Biliary Obstruction","sponsor":"Shanghai Guangsheng Biopharmaceutical Co., Ltd","started":"2026-03-31","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"cosmic-313","kind":"trial","name":"COSMIC-313","aka":[],"tldr":"The first triplet trial in kidney cancer slowed progression but did not help patients live longer, and added toxicity.","summary":"COSMIC-313, trial NCT03937219 sponsored by Exelixis and reported in 2022, was the first triplet trial in kidney cancer, and it slowed progression but did not help patients live longer while adding toxicity. It randomised 855 patients with untreated intermediate or poor-risk clear-cell renal cell carcinoma to cabozantinib plus nivolumab and ipilimumab or the doublet alone, met its primary progression-free survival endpoint, but showed no overall survival difference at the final analysis with far more severe adverse events, and poor-risk patients did not benefit even on progression; the triplet was not approved. OnCo links it to renal cell carcinoma, cabozantinib, nivolumab, ipilimumab and Sumanta K. Pal. Whether any third agent can add to an immunotherapy doublet is the open question.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03937219","url":"https://clinicaltrials.gov/study/NCT03937219"}],"tags":["lesson:pfs-without-os"],"related":[],"cancers":["rcc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["cabozantinib","nivolumab","ipilimumab"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sumanta-pal"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03937219","phase":"3","setting":"Untreated intermediate/poor-risk clear-cell RCC: cabozantinib + nivolumab + ipilimumab vs nivolumab + ipilimumab","sponsor":"Exelixis","result":"PFS HR 0.73; OS HR 1.02 (no benefit).","started":"2019-06-25","startedType":"actual","yearReported":2022,"enrolled":855,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"arms":[{"name":"Cabozantinib + nivolumab + ipilimumab","n":428},{"name":"Nivolumab + ipilimumab","n":427}],"hr":0.73,"ci":[0.57,0.94],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2212851"},{"endpoint":"Overall survival (final)","unit":"months","arms":[{"name":"Triplet","value":41.9},{"name":"Doublet","value":42}],"hr":1.02,"ci":[0.85,1.23],"source":"https://www.annalsofoncology.org/article/S0923-7534(26)00067-0/fulltext"}],"replication":"Consistent with LITESPARK-012: first-line triplets have not improved OS in RCC."},{"id":"cou-aa-301","kind":"trial","name":"COU-AA-301","aka":["COU-AA-301","abiraterone after docetaxel"],"tldr":"Proved that prostate cancer which has stopped responding to standard hormone therapy is still driven by androgens, by blocking the enzyme that makes them and adding about four months of life.","summary":"The premise of castration-resistant prostate cancer used to be that the disease had escaped hormonal control. COU-AA-301 tested the opposite hypothesis, that androgens made outside the testes, in the adrenal glands and the tumour itself, keep driving it, and that blocking CYP17 would work.\n\nIt randomised 1,195 men who had already received docetaxel 2:1 to abiraterone acetate 1000 mg daily with prednisone (797) or placebo with prednisone (398). At a median 12.8 months, overall survival was 14.8 against 10.9 months, hazard ratio 0.65 (95 percent confidence interval 0.54 to 0.77, p<0.001). The data were unblinded at the interim analysis because the result exceeded the preplanned stopping criteria. Time to PSA progression was 10.2 against 6.6 months (p<0.001), radiographic progression-free survival 5.6 against 3.6 months (p<0.001) and PSA response 29 against 6 percent (p<0.001).\n\nThe side effects follow from the mechanism: blocking CYP17 raises mineralocorticoids, so fluid retention, hypertension and hypokalaemia were more common with abiraterone, which is why it is given with a steroid.\n\nIn England NICE TA259 recommends abiraterone with prednisone or prednisolone after one docetaxel-containing regimen, subject to the commercial access arrangement.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00638690","url":"https://clinicaltrials.gov/study/NCT00638690"},{"label":"COU-AA-301 (New England Journal of Medicine 2011)","url":"https://doi.org/10.1056/NEJMoa1014618"},{"label":"NICE TA259: abiraterone for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen","url":"https://www.nice.org.uk/guidance/ta259"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":["androgen-receptor"],"drugs":["abiraterone","prednisone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["arpi","castration-resistance","psa50"],"trials":["cou-aa-302","affirm","tax-327"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00638690","phase":"3","setting":"Metastatic castration-resistant prostate cancer after docetaxel: prednisone 5 mg twice daily for everyone, with abiraterone acetate 1000 mg daily or placebo, randomised 2:1, with overall survival as the primary endpoint","sponsor":"Cougar Biotechnology, later Janssen","result":"Median overall survival 14.8 against 10.9 months (hazard ratio 0.65, 95 percent confidence interval 0.54 to 0.77) with abiraterone after docetaxel; PSA response 29 against 6 percent.","started":"2008-05","yearReported":2011,"enrolled":1195,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Abiraterone acetate with prednisone","n":797,"value":14.8},{"name":"Placebo with prednisone","n":398,"value":10.9}],"hr":0.65,"ci":[0.54,0.77],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1014618"},{"endpoint":"Radiographic progression-free survival (median)","unit":"months","arms":[{"name":"Abiraterone acetate with prednisone","n":797,"value":5.6},{"name":"Placebo with prednisone","n":398,"value":3.6}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1014618"}],"replication":"AFFIRM found the same in the same setting with enzalutamide (18.4 against 13.6 months); COU-AA-302 moved abiraterone before chemotherapy."},{"id":"cou-aa-302","kind":"trial","name":"COU-AA-302","aka":["COU-AA-302","abiraterone before chemotherapy"],"tldr":"Moved abiraterone in front of chemotherapy, doubling the time before scans showed the cancer growing and putting off the day chemotherapy and opiates were needed.","summary":"COU-AA-302 randomised 1,088 men with metastatic castration-resistant prostate cancer and no previous chemotherapy to abiraterone acetate 1000 mg with prednisone or placebo with prednisone. The study was unblinded after a planned interim analysis at 43 percent of expected deaths.\n\nMedian radiographic progression-free survival was 16.5 months with abiraterone against 8.3 months with prednisone alone, hazard ratio 0.53 (95 percent confidence interval 0.45 to 0.62, p<0.001). Over a median 22.2 months, overall survival was improved, median not reached against 27.2 months, hazard ratio 0.75 (0.61 to 0.93, p=0.01), but did not cross the prespecified efficacy boundary at that analysis.\n\nThe endpoints that describe daily life all favoured abiraterone: time to starting cytotoxic chemotherapy, time to opiate use for cancer-related pain, time to PSA progression and time to decline in performance status. Grade 3 or 4 mineralocorticoid-related adverse events and liver function abnormalities were more common with abiraterone.\n\nIn England NICE TA387 recommends abiraterone with prednisone or prednisolone for metastatic hormone-relapsed prostate cancer in men with no or mild symptoms after androgen deprivation has failed and before chemotherapy is indicated, subject to the commercial access arrangement.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00887198","url":"https://clinicaltrials.gov/study/NCT00887198"},{"label":"COU-AA-302 (New England Journal of Medicine 2013)","url":"https://doi.org/10.1056/NEJMoa1209096"},{"label":"NICE TA387: abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated","url":"https://www.nice.org.uk/guidance/ta387"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":["androgen-receptor"],"drugs":["abiraterone","prednisone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["arpi","castration-resistance"],"trials":["cou-aa-301","prevail"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00887198","phase":"3","setting":"Metastatic castration-resistant prostate cancer with no previous chemotherapy: abiraterone acetate 1000 mg with prednisone 5 mg twice daily against placebo with prednisone, with co-primary endpoints of radiographic progression-free survival and overall survival","sponsor":"Janssen Research and Development, formerly Cougar Biotechnology","result":"Median radiographic progression-free survival 16.5 against 8.3 months (hazard ratio 0.53, 95 percent confidence interval 0.45 to 0.62) and overall survival not reached against 27.2 months (0.75, 0.61 to 0.93) before chemotherapy.","started":"2009-04-28","startedType":"actual","yearReported":2013,"enrolled":1088,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Abiraterone acetate with prednisone","value":16.5},{"name":"Placebo with prednisone","value":8.3}],"hr":0.53,"ci":[0.45,0.62],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1209096"},{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Abiraterone acetate with prednisone","note":"not reached Did not cross the prespecified efficacy boundary at the interim analysis."},{"name":"Placebo with prednisone","value":27.2}],"hr":0.75,"ci":[0.61,0.93],"p":"0.01","source":"https://doi.org/10.1056/NEJMoa1209096"}],"replication":"PREVAIL found the same for enzalutamide before chemotherapy in 1,717 men, with an overall survival hazard ratio of 0.71."},{"id":"nct05733000","kind":"trial","name":"CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors","aka":[],"tldr":"A phase 2 trial of gemcitabine and fluorouracil in gallbladder cancer and other biliary tract cancers, run by Northwestern University, now recruiting.","summary":"CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors is a phase 2 interventional study registered as NCT05733000 by Northwestern University, with a registry enrolment figure of 94 participants, started 2023-03-08 and due to reach its primary completion in 2028-01-04. Interventions recorded: Biospecimen Collection, Computed Tomography, Devimistat, Fluorouracil, Gemcitabine Hydrochloride, Hydroxychloroquine, Magnetic Resonance Imaging. Conditions listed: Advanced Biliary Tract Carcinoma, Advanced Colorectal Carcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Advanced Lung Adenocarcinoma, Advanced Malignant Solid Neoplasm, Advanced Ovarian Carcinoma, Advanced Pancreatic Carcinoma, Advanced Urothelial Carcinoma, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Metastatic Biliary Tract Carcinoma, Metastatic Colorectal Carcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Metastatic Lung Adenocarcinoma, Metastatic Ovarian Carcinoma, Metastatic Pancreatic Carcinoma, Metastatic Urothelial Carcinoma, Refractory Biliary Tract Carcinoma, Refractory Colorectal Carcinoma, Refractory Gastroesophageal Junction Adenocarcinoma, Refractory Lung Adenocarcinoma, Refractory Ovarian Carcinoma, Refractory Pancreatic Carcinoma, Refractory Urothelial Carcinoma, Stage II Pancreatic Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05733000","url":"https://clinicaltrials.gov/study/NCT05733000"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05733000","phase":"2","setting":"Phase II Open-Label Multi-Cohort Study Evaluating CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Patients With Advanced Chemorefractory Colorectal, Pancreatic, or Other Solid Cancers","sponsor":"Northwestern University","started":"2023-03-08","startedType":"actual","enrolled":94,"enrolledBasis":"registry","outcomes":[]},{"id":"cpx-351-301","kind":"trial","name":"CPX-351 Study 301","aka":[],"tldr":"Repackaging two old chemotherapies into liposomes doubled five-year survival in older adults with the worst kinds of AML.","summary":"CPX-351 Study 301, trial NCT01696084 sponsored by Celator, now Jazz, and published in JCO in 2018 with a five-year update in Lancet Haematology in 2021, showed that repackaging daunorubicin and cytarabine into liposomes doubled five-year survival in adults aged 60 to 75 with newly diagnosed high-risk or secondary acute myeloid leukaemia. It randomised 309 patients to CPX-351 or conventional 7+3 chemotherapy, met its primary overall survival endpoint, raised the remission rate, and more patients reached transplant with longer survival afterwards. OnCo links it to acute myeloid leukaemia, the CPX-351 record and the 7+3 regimen. There is no second randomised trial, although the UK NCRI AML19 trial and real-world registries report comparable remission rates in secondary disease, and whether the benefit holds in younger patients or against venetoclax-based regimens is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01696084","url":"https://clinicaltrials.gov/study/NCT01696084"}],"tags":[],"related":[],"cancers":["aml","aml-secondary"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cpx-351","cytarabine-7-3"],"companies":["jazz"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01696084","phase":"3","setting":"Newly diagnosed high-risk or secondary AML, age 60-75: CPX-351 vs conventional 7+3","sponsor":"Celator / Jazz","result":"OS 9.56 vs 5.95 months, HR 0.69; 5-year OS 18% vs 8%.","started":"2012-12-13","startedType":"actual","yearReported":2018,"enrolled":309,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"CPX-351","n":153,"value":9.56},{"name":"7+3","n":156,"value":5.95}],"hr":0.69,"ci":[0.52,0.9],"p":"0.003","source":"https://ascopubs.org/doi/10.1200/JCO.2017.77.6112"},{"endpoint":"5-year overall survival","unit":"%","arms":[{"name":"CPX-351","value":18},{"name":"7+3","value":8}],"source":"https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(21)00134-4/abstract"}],"replication":"No second randomised trial; UK NCRI AML19 and real-world registries report comparable remission rates in secondary AML."},{"id":"nct07335497","kind":"trial","name":"CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors","aka":["ASCEND"],"tldr":"A phase 1/2 trial of CR-001 in advanced solid tumours, run by Crescent Biopharma, Inc., now recruiting.","summary":"CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT07335497 by Crescent Biopharma, Inc., with 290 participants planned, started 2026-02-17 and due to reach its primary completion in 2029-02. Interventions recorded: CR-001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07335497","url":"https://clinicaltrials.gov/study/NCT07335497"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07335497","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors","sponsor":"Crescent Biopharma, Inc.","started":"2026-02-17","startedType":"actual","enrolled":290,"enrolledBasis":"registry","outcomes":[]},{"id":"create-x","kind":"trial","name":"CREATE-X","aka":["JBCRG-04","CREATE-X/JBCRG-04","UMIN000000843"],"tldr":"CREATE-X showed that giving the tablet chemotherapy capecitabine for six months after surgery, to women whose breast cancer had not fully disappeared with pre-operative chemotherapy, cut deaths; the gain was largest in triple-negative disease, where five-year survival rose from 70 to 79 percent.","summary":"CREATE-X (UMIN000000843) randomised 910 patients with HER2-negative residual invasive breast cancer after neoadjuvant chemotherapy containing an anthracycline, a taxane or both to standard post-surgical treatment with or without capecitabine 1,250 mg/m2 twice daily on days 1 to 14 of 21 for six to eight cycles. The trial stopped early when a prespecified interim analysis met the primary endpoint. Five-year disease-free survival was 74.1 versus 67.6 percent (hazard ratio 0.70, 95 percent confidence interval 0.53 to 0.92, p 0.01) and five-year overall survival 89.2 versus 83.6 percent (hazard ratio 0.59, 0.39 to 0.90, p 0.01). In the triple-negative subgroup disease-free survival was 69.8 versus 56.1 percent (hazard ratio 0.58, 0.39 to 0.87) and overall survival 78.8 versus 70.3 percent (hazard ratio 0.52, 0.30 to 0.90). Hand-foot syndrome occurred in 73.4 percent of the capecitabine group.\n\nCREATE-X predates immunotherapy: none of its patients had pembrolizumab, and whether capecitabine adds to adjuvant pembrolizumab after residual disease on the KEYNOTE-522 regimen has never been tested directly; it is the physician's-choice control in ASCENT-05/OptimICE-RD and TROPION-Breast03. The Spanish GEICAM/CIBOMA trial of extended adjuvant capecitabine in unselected early triple-negative disease was negative and SYSUCC-001 (metronomic capecitabine for a year) positive for disease-free survival, so the evidence for capecitabine is strongest in the CREATE-X population, residual disease after neoadjuvant chemotherapy. The trial has no ClinicalTrials.gov record; it is registered with the UMIN Clinical Trials Registry.","status":"positive","asOf":"2026-09-24","links":[{"label":"Masuda et al., NEJM 2017: adjuvant capecitabine for breast cancer after preoperative chemotherapy (CREATE-X)","url":"https://doi.org/10.1056/NEJMoa1612645"},{"label":"UMIN000000843","url":"https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001004"}],"tags":["registry:umin"],"related":[],"cancers":["tnbc","tnbc-early","breast-hr-positive"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":["rcb","efs","hand-foot-syndrome","tnbc-residual-disease-decision"],"trials":["sysucc-001","geicam-ciboma","ea1131","ascent-05","tropion-breast03"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registered as UMIN000000843 with the UMIN Clinical Trials Registry; no ClinicalTrials.gov entry. The 910 randomised patients were split 1 to 1; subgroup arm sizes are not given in the abstract.","Hand-foot syndrome, the most common adverse reaction, occurred in 73.4 percent of the capecitabine group."],"phase":"3","setting":"HER2-negative breast cancer with residual invasive disease after neoadjuvant anthracycline, taxane or both: standard post-surgical treatment with or without six to eight cycles of capecitabine, Japan and Korea","sponsor":"Japan Breast Cancer Research Group / Advanced Clinical Research Organization","result":"5-year DFS 74.1% vs 67.6% (HR 0.70); OS 89.2% vs 83.6% (HR 0.59). TNBC subgroup: DFS 69.8% vs 56.1% (HR 0.58), OS 78.8% vs 70.3% (HR 0.52).","yearReported":2017,"enrolled":910,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Capecitabine","value":74.1},{"name":"Control","value":67.6}],"hr":0.7,"ci":[0.53,0.92],"p":"0.01","source":"https://doi.org/10.1056/NEJMoa1612645"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Capecitabine","value":89.2},{"name":"Control","value":83.6}],"hr":0.59,"ci":[0.39,0.9],"p":"0.01","source":"https://doi.org/10.1056/NEJMoa1612645"},{"endpoint":"Disease-free survival at 5 years, triple-negative subgroup","unit":"%","arms":[{"name":"Capecitabine","value":69.8},{"name":"Control","value":56.1}],"hr":0.58,"ci":[0.39,0.87],"source":"https://doi.org/10.1056/NEJMoa1612645"},{"endpoint":"Overall survival at 5 years, triple-negative subgroup","unit":"%","arms":[{"name":"Capecitabine","value":78.8},{"name":"Control","value":70.3}],"hr":0.52,"ci":[0.3,0.9],"source":"https://doi.org/10.1056/NEJMoa1612645"}],"replication":"SYSUCC-001 (metronomic capecitabine after adjuvant chemotherapy) also improved disease-free survival; GEICAM/CIBOMA in unselected early TNBC did not; EA1131 found platinum no better than capecitabine for residual disease."},{"id":"crest-thoracic-rt","kind":"trial","name":"CREST: consolidation thoracic radiotherapy in extensive-stage small-cell lung cancer","aka":["CREST","Slotman thoracic radiotherapy trial"],"tldr":"Radiotherapy to the chest after chemotherapy for widespread small-cell lung cancer missed its main target but tripled two-year survival, which is why it is still offered.","summary":"Most patients with extensive-stage small-cell lung cancer who respond to chemotherapy still have disease in the chest, and it is usually where they relapse. CREST randomised 495 such patients at 42 hospitals in the Netherlands, the United Kingdom, Norway and Belgium between February 2009 and December 2012 to thoracic radiotherapy, 30 Gy in ten fractions, or to none; all received prophylactic cranial irradiation. The mean interval from diagnosis to randomisation was 17 weeks.\n\nThe primary endpoint, one-year overall survival, was not met: 33 percent (95 percent confidence interval 27 to 39) with thoracic radiotherapy against 28 percent (22 to 34), hazard ratio 0.84 (0.69 to 1.01, p=0.066). In a secondary analysis, two-year overall survival was 13 percent against 3 percent (p=0.004), and progression was less likely with radiotherapy (hazard ratio 0.73, 0.61 to 0.87, p=0.001), with six-month progression-free survival 24 against 7 percent. No severe toxic effects were recorded; the commonest grade 3 or worse events were fatigue and breathlessness, in single figures.\n\nCREST is the reason consolidation thoracic radiotherapy is offered to patients with residual thoracic disease after chemotherapy, and the reason it is offered as a discussion rather than as a rule: the trial predates the addition of atezolizumab and durvalumab to first-line chemotherapy, and whether the benefit survives alongside immunotherapy is being tested now.","status":"mixed","asOf":"2026-09-25","links":[{"label":"CREST (Lancet 2015)","url":"https://doi.org/10.1016/S0140-6736(14)61085-0"},{"label":"Netherlands Trial Register NTR1527","url":"https://onderzoekmetmensen.nl/en/trial/21669"}],"tags":[],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["imrt-igrt","hypofractionated-radiotherapy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["consolidation-therapy","palliative-treatment"],"trials":["impower133","caspian","slotman-pci-es-sclc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NTR1527","phase":"3","setting":"Extensive-stage small-cell lung cancer responding to chemotherapy, performance status 0 to 2, all receiving prophylactic cranial irradiation: thoracic radiotherapy 30 Gy in ten fractions versus no thoracic radiotherapy, with overall survival at one year as the primary endpoint","sponsor":"VU University Medical Center Amsterdam, with the Dutch, UK, Norwegian and Belgian groups","result":"One-year overall survival 33 against 28 percent (hazard ratio 0.84, p=0.066, primary endpoint not met); two-year survival 13 against 3 percent (p=0.004).","yearReported":2015,"enrolled":495,"enrolledBasis":"analysed","enrolledNote":"498 patients were randomised and three withdrew consent, leaving 495 analysed; the trial is registered in the Netherlands Trial Register as NTR1527, not on ClinicalTrials.gov.","outcomes":[{"endpoint":"Overall survival at 1 year","primary":true,"unit":"%","arms":[{"name":"Thoracic radiotherapy 30 Gy in 10 fractions","n":247,"value":33},{"name":"No thoracic radiotherapy","n":248,"value":28}],"hr":0.84,"ci":[0.69,1.01],"p":"0.066","source":"https://doi.org/10.1016/S0140-6736(14)61085-0"},{"endpoint":"Overall survival at 2 years","unit":"%","arms":[{"name":"Thoracic radiotherapy 30 Gy in 10 fractions","n":247,"value":13},{"name":"No thoracic radiotherapy","n":248,"value":3}],"p":"0.004","source":"https://doi.org/10.1016/S0140-6736(14)61085-0"}]},{"id":"cross","kind":"trial","name":"CROSS","aka":[],"tldr":"The trial that made chemotherapy plus radiation before surgery the standard for oesophageal cancer; the survival gain was still there ten years later.","summary":"CROSS randomised 368 patients with resectable oesophageal or gastro-oesophageal junction cancer to surgery alone or five weekly cycles of carboplatin-paclitaxel with 41.4 Gy in 23 fractions followed by surgery. Median overall survival was 49.4 months with chemoradiation versus 24.0 months with surgery alone, 29 percent had a pathological complete response, and surgical complications were not increased (van Hagen and colleagues, New England Journal of Medicine 2012). Ten-year follow-up confirmed the benefit; the CROSS regimen is a worldwide standard.\n\nOS 49.4 vs 24.0 months (NEJM 2012); pCR 29% (49% in squamous). Ten-year OS 38% vs 25% (JCO 2021), HR for death from oesophageal cancer 0.60. The CROSS regimen is the reference arm for CheckMate 577, SANO, and most modern trials; perioperative FLOT is the alternative for adenocarcinoma (ESOPEC 2024 favoured FLOT).","status":"positive","asOf":"2026-09-07","links":[{"label":"NEJM 2012","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1112088"},{"label":"10-year outcomes, JCO 2021","url":"https://ascopubs.org/doi/10.1200/JCO.20.03614"}],"tags":[],"related":[],"cancers":["esophageal","oesophageal-squamous-cell-carcinoma","oesophageal-adenocarcinoma","gastric"],"sections":[],"technologies":["imrt-igrt","platinum","cytotoxic-chemotherapy","radiosensitisers"],"targets":[],"drugs":["carboplatin","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","pcr","chemoradiation"],"trials":[],"people":["jan-van-lanschot","kitagawa-yuko"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NTR487","phase":"3","setting":"Resectable oesophageal or junctional cancer (squamous and adenocarcinoma): weekly carboplatin/paclitaxel + 41.4 Gy radiation then surgery vs surgery alone","sponsor":"Dutch Cancer Society (Erasmus MC)","result":"10-year OS 38% vs 25%; median OS 49.4 vs 24.0 months.","yearReported":2012,"enrolled":366,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Chemoradiation + surgery","n":178,"value":49.4},{"name":"Surgery alone","n":188,"value":24}],"hr":0.68,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1112088"},{"endpoint":"Overall survival at 10 years","unit":"percent","arms":[{"name":"Chemoradiation + surgery","value":38},{"name":"Surgery alone","value":25}],"source":"https://ascopubs.org/doi/10.1200/JCO.20.03614"}],"replication":"Durable at 10 years; NEO-AEGIS and ESOPEC compared it against perioperative chemotherapy in adenocarcinoma with FLOT favoured in ESOPEC."},{"id":"crossfire","kind":"trial","name":"CROSSFIRE","aka":["CROSSFIRE trial"],"tldr":"CROSSFIRE is the only randomised comparison of the two local treatments offered after chemotherapy for pancreatic cancer that cannot be removed, MR-guided stereotactic radiotherapy and irreversible electroporation; survival was 16.1 against 12.5 months with no significant difference, the trial stopped early for futility, and neither has been shown to beat chemotherapy alone.","summary":"CROSSFIRE randomised 68 patients between May 2016 and March 2022 (34 to SABR, 34 to irreversible electroporation). Median overall survival from randomisation was 16.1 months (95 percent confidence interval 12.1 to 19.4) with SABR against 12.5 months (10.9 to 17.0) with electroporation (hazard ratio 1.39, 0.84 to 2.30; p 0.21); the conditional probability of showing superiority of either technique was 0.13 and accrual stopped. Adverse events occurred in 63 against 59 percent, grade 3 to 5 in 16 against 25 percent (cholangitis, abdominal pain and pancreatitis the commonest), with one treatment-related death in each arm. The authors asked future trials to test local ablation against chemotherapy alone; the corpus's locally advanced row cites it beside PANFIRE-2 (single-arm electroporation, 17 months from diagnosis) and LAP07.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02791503","url":"https://clinicaltrials.gov/study/NCT02791503"},{"label":"Timmer et al., CROSSFIRE (Lancet Gastroenterology and Hepatology 2024)","url":"https://doi.org/10.1016/S2468-1253(24)00017-7"}],"tags":[],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":["sbrt","mr-linac","irreversible-electroporation"],"targets":[],"drugs":["folfirinox"],"companies":[],"institutions":[],"pathways":[],"terms":["acute-cholangitis"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02791503","phase":"2","setting":"Stage III locally advanced pancreatic cancer of 5 cm or less after three to eight cycles of FOLFIRINOX at a single Dutch centre: MRI-guided stereotactic ablative radiotherapy (five fractions of 8 Gy) against CT-guided percutaneous irreversible electroporation, with overall survival from randomisation as the primary endpoint","sponsor":"Amsterdam University Medical Centre (M. R. Meijerink), with the Adessium Foundation and AngioDynamics","result":"Median overall survival 16.1 months with MRI-guided stereotactic ablative radiotherapy against 12.5 months with irreversible electroporation (hazard ratio 1.39, 95 percent confidence interval 0.84 to 2.30; p 0.21); stopped for futility.","started":"2016-05-30","yearReported":2024,"enrolled":68,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov NCT02791503 lists 74 participants (actual); 68 were enrolled and randomised (34 per arm) and 64 treated per protocol according to the Lancet Gastroenterology and Hepatology 2024 report, which stopped accrual early for futility.","outcomes":[{"endpoint":"Overall survival from randomisation","primary":true,"unit":"months","arms":[{"name":"MRI-guided SABR (5 x 8 Gy)","n":34,"value":16.1,"note":"95% CI 12.1 to 19.4"},{"name":"CT-guided percutaneous irreversible electroporation","n":34,"value":12.5,"note":"95% CI 10.9 to 17.0"}],"hr":1.39,"ci":[0.84,2.3],"p":"0.21","source":"https://doi.org/10.1016/S2468-1253(24)00017-7"}]},{"id":"crown","kind":"trial","name":"CROWN","aka":[],"tldr":"The trial with the longest disease control ever seen for a targeted lung cancer pill: most patients still progression-free at five years.","summary":"296 patients. At 5 years, PFS was 60% with lorlatinib versus 8% with crizotinib (HR 0.19); median PFS not reached after >60 months of follow-up. Intracranial progression was nearly abolished (5-year cumulative incidence ~8% in patients without baseline brain metastases). Neurocognitive, mood, weight, and lipid effects require management.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT03052608","url":"https://clinicaltrials.gov/study/NCT03052608"}],"tags":[],"related":[],"cancers":["nsclc","secondary-brain-tumours","alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["lorlatinib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ross-camidge","solomon-benjamin","ahn-myung-ju"],"bottlenecks":[],"keyPapers":["paper-shaw-crown-lorlatinib-crizotinib-nejm-2020","paper-crown-lancet-respir-med-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03052608","phase":"3","setting":"First-line ALK-positive advanced NSCLC: lorlatinib vs crizotinib","sponsor":"Pfizer","result":"5-year PFS 60% vs 8%, HR 0.19 (JCO 2024).","started":"2017-04-27","startedType":"actual","yearReported":2020,"enrolled":296,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 5 years (BICR)","primary":true,"unit":"%","arms":[{"name":"Lorlatinib","n":149,"value":60},{"name":"Crizotinib","n":147,"value":8}],"hr":0.19,"ci":[0.13,0.27],"source":"https://ascopubs.org/doi/10.1200/JCO.24.00581"},{"endpoint":"Intracranial progression at 5 years","unit":"%","arms":[{"name":"Lorlatinib","value":8,"note":"Cumulative incidence in patients without baseline brain metastases"},{"name":"Crizotinib","value":40}],"source":"https://ascopubs.org/doi/10.1200/JCO.24.00581"}],"replication":"Single pivotal trial versus crizotinib; consistent with ALEX (alectinib) and eXalt3 (ensartinib) for the class, with lorlatinib showing the longest PFS."},{"id":"nct07829874","kind":"trial","name":"Cryoablation Combined With QL1706 (Iparomlimab/Tuvonralimab) Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer.","aka":["CASTLE-ZS-04"],"tldr":"A phase 2 trial of lenvatinib in gallbladder cancer and other biliary tract cancers, run by Fudan University, not yet recruiting.","summary":"Cryoablation Combined With QL1706 (Iparomlimab/Tuvonralimab) Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer. is a phase 2, randomised interventional study registered as NCT07829874 by Fudan University, with a registry enrolment figure of 180 participants, started 2026-09-20 and due to reach its primary completion in 2028-09-20. Interventions recorded: QL1706 (Iparomlimab/Tuvonralimab), Lenvatinib, Cryoablation. Conditions listed: Biliary Tract Cancer (BTC). Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07829874","url":"https://clinicaltrials.gov/study/NCT07829874"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07829874","phase":"2","setting":"QL1706 (Iparomlimab/Tuvonralimab) Plus Lenvatinib With or Without Cryoablation for Advanced Biliary Tract Cancer (CASTLE-ZS-04): a Multicenter, Randomized, Phase 2 Study","sponsor":"Fudan University","started":"2026-09-20","startedType":"estimated","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05057052","kind":"trial","name":"Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis","aka":["CASTLE-03"],"tldr":"A phase 2 trial of sintilimab and regorafenib in colorectal cancer, run by Fudan University, now recruiting.","summary":"Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis is a phase 2, interventional study registered as NCT05057052 by Fudan University, with a registry enrolment figure of 25 participants, started 2021-09-26 and due to reach its primary completion in 2026-09-25. Interventions recorded: Sintilimab; Regorafenib; US/CT-guided Percutaneous Cryoablation. Conditions listed: Liver Metastases; Colorectal Cancer Metastatic. Primary outcome: Objective Response Rate (ORR). Colorectal eligibility wording from the registry: \"* Participants must have colorectal cancer liver metastasis\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05057052","url":"https://clinicaltrials.gov/study/NCT05057052"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors","thermal-ablation"],"targets":[],"drugs":["sintilimab","regorafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05057052","phase":"2","setting":"A Phase II Study of Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis (CASTLE-03)","sponsor":"Fudan University","started":"2021-09-26","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07306286","kind":"trial","name":"Cryoablation Combined With the Dual-Function Antibody PD-1/CTLA-4 for the Treatment of LAPC Following Failure of First-Line AG Therapy","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Ruijin Hospital, now recruiting.","summary":"Cryoablation Combined With the Dual-Function Antibody PD-1/CTLA-4 for the Treatment of LAPC Following Failure of First-Line AG Therapy is a phase 2, interventional study registered as NCT07306286 by Ruijin Hospital, with a registry enrolment figure of 20 participants, started 2025-12-15 and due to reach its primary completion in 2027-08-01. Interventions recorded: Cryoablation; Dual-Function Antibody PD-1/CTLA-4. Conditions listed: Pancreatic Adenocarcinoma Locally Advanced. Primary outcome: Overall Survival. Pancreatic eligibility wording from the registry: \"* Pathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records indicating locally advanced pancreatic cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07306286","url":"https://clinicaltrials.gov/study/NCT07306286"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07306286","phase":"2","setting":"A Single-Arm, Open-Label Clinical Study of Cryoablation Combined With the Dual-Function Antibody PD-1/CTLA-4 (Apalulizumab) for the Treatment of Locally Advanced Pancreatic Cancer Following Failure of First-Line AG Therapy","sponsor":"Ruijin Hospital","started":"2025-12-15","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04339218","kind":"trial","name":"Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma","aka":["CRYOMUNE"],"tldr":"A phase 3 trial of pembrolizumab, pemetrexed and carboplatin in lung cancer, run by Institut Bergonié, now recruiting.","summary":"Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma is a phase 3, randomised interventional study registered as NCT04339218 by Institut Bergonié, with a registry enrolment figure of 214 participants, started 2020-08-28 and due to reach its primary completion in 2026-08-27. Interventions recorded: Cryoablation; Pembrolizumab; Pemetrexed; Carboplatin. Conditions listed: Lung Adenocarcinoma; Cryotherapy Effect. Primary outcome: 1-year overall survival rate. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed non-small lung adenocarcinoma\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04339218","url":"https://clinicaltrials.gov/study/NCT04339218"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","thermal-ablation"],"targets":[],"drugs":["pembrolizumab","pemetrexed","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04339218","phase":"3","setting":"Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in First-line Treatment for Patients With Metastatic Lung Adenocarcinoma: A Randomized Phase III Study","sponsor":"Institut Bergonié","started":"2020-08-28","startedType":"actual","enrolled":214,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07483996","kind":"trial","name":"Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer","aka":[],"tldr":"A phase 3 trial of Thermal ablation in Breast cancer, run by Franciscus Gasthuis & Vlietland (Hospital), not yet recruiting.","summary":"Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer is a phase 3 interventional study registered as NCT07483996 by Franciscus Gasthuis & Vlietland (Hospital), with 938 participants planned, started 2026-04-01 and due to reach its primary completion in 2035-12-31. Interventions recorded: Percutaneous cryoablation, Breast-conserving surgery. Conditions recorded: Early-Stage Breast Cancer.\n\nLinked to the technology Thermal ablation because the registry names it (\"thermal ablation\") among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07483996","url":"https://clinicaltrials.gov/study/NCT07483996"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["thermal-ablation"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07483996","phase":"3","setting":"Cryoablation as Alternative for Lumpectomy in Early-Stage Breast Cancer: The CRYSTAL Trial","sponsor":"Franciscus Gasthuis & Vlietland (Hospital)","started":"2026-04-01","startedType":"estimated","enrolled":938,"enrolledBasis":"registry","outcomes":[]},{"id":"crystal-fire3","kind":"trial","name":"CRYSTAL & FIRE-3","aka":["CRYSTAL","FIRE-3","CRYSTAL and FIRE-3"],"tldr":"The trials that established EGFR antibodies in bowel cancer and discovered they only work when the RAS gene is normal.","summary":"CRYSTAL (NEJM 2009) showed cetuximab + FOLFIRI improved PFS and, in KRAS wild-type tumours, OS (23.5 vs 20.0 months). Retrospective RAS analyses defined the first negative predictive biomarker in CRC. FIRE-3 (Lancet Oncology 2014) showed longer OS with cetuximab than bevacizumab in KRAS wild-type disease (28.7 vs 25.0 months), later shown to be driven by left-sided tumours.","status":"positive","asOf":"2026-09-07","links":[{"label":"CRYSTAL, NEJM 2009","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa0805019"},{"label":"ClinicalTrials.gov NCT00154102","url":"https://clinicaltrials.gov/study/NCT00154102"},{"label":"ClinicalTrials.gov NCT00433927","url":"https://clinicaltrials.gov/study/NCT00433927"},{"label":"CRYSTAL: cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer (New England Journal of Medicine 2009)","url":"https://doi.org/10.1056/NEJMoa0805019"},{"label":"FIRE-3: FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment (Lancet Oncology 2014)","url":"https://doi.org/10.1016/S1470-2045(14)70330-4"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["egfr","kras"],"drugs":["cetuximab","bevacizumab","folfiri"],"companies":["aio"],"institutions":[],"pathways":[],"terms":["sidedness"],"trials":["prime","opus","calgb-80405"],"people":["volker-heinemann","eric-van-cutsem"],"bottlenecks":[],"keyPapers":["paper-tejpar-tumour-location-crystal-fire3-jama-oncol-2017","paper-arnold-primary-tumour-side-ras-wild-type-ann-oncol-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00154102","phase":"3","setting":"First-line metastatic colorectal cancer: FOLFIRI ± cetuximab (CRYSTAL); FOLFIRI + cetuximab vs FOLFIRI + bevacizumab (FIRE-3)","sponsor":"Merck KGaA; AIO (Germany)","result":"CRYSTAL KRAS-WT OS 23.5 vs 20.0 months; FIRE-3 OS 28.7 vs 25.0 months.","started":"2004-05","yearReported":2009,"enrolled":1198,"enrolledBasis":"randomised","enrolledNote":"Two trials under one record: CRYSTAL (NCT00154102) randomised 1,198 patients, 599 per arm, and FIRE-3 (NCT00433927) treated 592 patients with KRAS exon 2 wild-type tumours.","outcomes":[{"endpoint":"Overall survival, KRAS wild-type (CRYSTAL)","unit":"months","arms":[{"name":"FOLFIRI + cetuximab","value":23.5},{"name":"FOLFIRI","value":20}],"hr":0.8,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa0805019"},{"endpoint":"CRYSTAL: progression-free survival (KRAS wild-type)","unit":"hazard ratio","arms":[{"name":"FOLFIRI plus cetuximab","value":0.68},{"name":"FOLFIRI","value":1}],"hr":0.68,"ci":[0.5,0.94],"source":"https://doi.org/10.1056/NEJMoa0805019"},{"endpoint":"FIRE-3: overall survival (KRAS exon 2 wild-type)","unit":"months","arms":[{"name":"FOLFIRI plus cetuximab","n":297,"value":28.7},{"name":"FOLFIRI plus bevacizumab","n":295,"value":25}],"hr":0.77,"ci":[0.62,0.96],"p":"0.017","source":"https://doi.org/10.1016/S1470-2045(14)70330-4"},{"endpoint":"FIRE-3: objective response (primary endpoint)","primary":true,"unit":"percent","arms":[{"name":"FOLFIRI plus cetuximab","n":297,"value":62},{"name":"FOLFIRI plus bevacizumab","n":295,"value":58}],"p":"0.18","source":"https://doi.org/10.1016/S1470-2045(14)70330-4"}],"replication":"Replicated by PRIME (panitumumab + FOLFOX) and PARADIGM."},{"id":"nct07595835","kind":"trial","name":"CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer","aka":["PANCOSIL"],"tldr":"A phase 1/2 trial in pancreatic cancer, run by M.R. Meijerink, now recruiting.","summary":"CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer is a phase 1/2, interventional study registered as NCT07595835 by M.R. Meijerink, with a registry enrolment figure of 20 participants, started 2023-06-04 and due to reach its primary completion in 2026-06-01. Interventions recorded: CT-guided percutaneous intratumoural implantation of the OncoSil™ device. Conditions listed: Pancreatic Cancer. Primary outcome: Safety defined as the rate of procedure- or device-related CTCAE grade ≥3 adverse events (AEs) within 90 days after implantion.. Pancreatic eligibility wording from the registry: \"* Locally advanced pancreatic cancer, defined by the DPCG consensus criteria as: arterial involvement \\>90 degrees or venous involvement \\>270 degrees\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07595835","url":"https://clinicaltrials.gov/study/NCT07595835"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07595835","phase":"1/2","setting":"Safety and Feasibility of CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer (PANCOSIL): an Open-label, Single-arm Phase 1-2 Feasibility Study","sponsor":"M.R. Meijerink","started":"2023-06-04","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04581473","kind":"trial","name":"CT041-ST-01","aka":["CT041 ST-01","satri-cel CT041-ST-01","Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection"],"tldr":"The Chinese randomised trial in which Claudin 18.2 CAR-T cells delayed progression compared with the doctor's choice of later-line drugs in stomach cancer, the first randomised trial of CAR-T cells in a solid tumour.","summary":"CT041-ST-01 is an open-label, multicentre phase Ib/II programme of satricabtagene autoleucel (satri-cel, CT041), an autologous Claudin 18.2 CAR-T, sponsored by CARsgen. The pivotal phase 2 portion randomised patients in China with Claudin 18.2-positive (immunohistochemistry intensity at least 2+ in at least 40 percent of tumour cells) advanced gastric or gastro-oesophageal junction cancer refractory to at least two previous lines, 2 to 1, to satri-cel or treatment of physician's choice (nivolumab, paclitaxel, docetaxel, irinotecan or rivoceranib). Satri-cel was infused up to three times at 250 million cells. Patients on physician's choice could receive satri-cel after progression or intolerance. The primary endpoint was progression-free survival by independent review in the intention-to-treat population.\n\nBetween March 2022 and July 2024, 266 patients were screened and 156 randomised (104 to satri-cel and 52 to physician's choice); 88 and 48 received study treatment. Median progression-free survival was 3.25 months with satri-cel versus 1.77 months with physician's choice (hazard ratio 0.37, 95% CI 0.24 to 0.56, one-sided log-rank p less than 0.0001). The authors describe it as the first randomised controlled trial of CAR T-cell therapy in solid tumours and conclude that it supports satri-cel as a third-line option (The Lancet 2025). The abstract does not report overall survival.\n\nSatri-cel is approved in China for Claudin 18.2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after earlier lines on this trial (see the drug record). The registry lists the broader phase Ib/II shell as active and no longer recruiting, with an estimated 192 participants including pancreatic cohorts that are outside this phase 2 report.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04581473","url":"https://clinicaltrials.gov/study/NCT04581473"},{"label":"The Lancet 2025","url":"https://doi.org/10.1016/S0140-6736(25)00860-8"}],"tags":["china"],"related":[],"cancers":["gastric","gastric-cldn18-2-positive"],"sections":[],"technologies":["car-t"],"targets":["cldn18-2"],"drugs":["satricabtagene-autoleucel"],"companies":["carsgen"],"institutions":["pku-cancer-hospital"],"pathways":[],"terms":[],"trials":[],"people":["qi-changsong","shen-lin"],"bottlenecks":[],"keyPapers":["paper-ct041-st-01-lancet-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04581473","phase":"1/2","setting":"CLDN18.2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after at least two prior lines, China: satricabtagene autoleucel versus treatment of physician's choice","sponsor":"CARsgen Therapeutics Co., Ltd.","result":"Median progression-free survival 3.25 vs 1.77 months (hazard ratio 0.37) in 156 randomised patients.","started":"2020-10-23","startedType":"actual","yearReported":2025,"enrolled":156,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov estimates 192 for the whole phase Ib/II registration (gastric and pancreatic cohorts); 156 were randomised in the phase 2 gastric or gastro-oesophageal junction cohort reported in The Lancet.","outcomes":[{"endpoint":"Progression-free survival (independent review, intention-to-treat)","primary":true,"unit":"months","arms":[{"name":"Satricabtagene autoleucel","n":104,"value":3.25,"note":"95% CI 2.86 to 4.53"},{"name":"Treatment of physician's choice","n":52,"value":1.77,"note":"95% CI 1.61 to 2.04"}],"hr":0.37,"ci":[0.24,0.56],"p":"<0.0001 (one-sided)","source":"https://doi.org/10.1016/S0140-6736(25)00860-8"}]},{"id":"nct06242418","kind":"trial","name":"CtDNA in Adjuvant Chemotherapy of Stage III Colon Cancer (REVISE Trial)","aka":["REVISE"],"tldr":"A phase 2 trial of FOLFOXIRI and cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by West China Hospital, now recruiting.","summary":"CtDNA in Adjuvant Chemotherapy of Stage III Colon Cancer (REVISE Trial) is a phase 2, randomised interventional study registered as NCT06242418 by West China Hospital, with a registry enrolment figure of 60 participants, started 2024-03-25 and due to reach its primary completion in 2025-12-31. Interventions recorded: FOLFOXIRI; XELOX. Conditions listed: Colon Cancer. Primary outcome: change in value of ctDNA concentration. Colorectal eligibility wording from the registry: \"Tumor located in the colon (the distance from the lower margin of the tumor to the anus is greater than 12 cm)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06242418","url":"https://clinicaltrials.gov/study/NCT06242418"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","mrd-testing","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfoxiri","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06242418","phase":"2","setting":"Value of CtDNA in Surveillance of Adjuvant Chemosensitivity and Regimen Adjustment in Stage III Colon Cancer: a Phase II Randomized Controlled Trial (REVISE Trial)","sponsor":"West China Hospital","started":"2024-03-25","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07188025","kind":"trial","name":"ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer","aka":["REACT"],"tldr":"A phase 3 trial in colorectal cancer, run by Erasmus Medical Center, now recruiting.","summary":"ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer is a phase 3, randomised interventional study registered as NCT07188025 by Erasmus Medical Center, with a registry enrolment figure of 103 participants, started 2025-10-14 and due to reach its primary completion in 2030-10. Interventions recorded: Adjuvant chemotherapy. Conditions listed: Rectal Cancer. Primary outcome: Disease-free survival, intention-to-treat. Colorectal eligibility wording from the registry: \"* Histological confirmed rectal cancer; either treated with neoadjuvant (chemo)radiotherapy, and/or clinical/pathological T3/T4 and/or N+ in case no neoadjuvant therapy was administered\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07188025","url":"https://clinicaltrials.gov/study/NCT07188025"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07188025","phase":"3","setting":"Adjuvant Chemotherapy for Prevention of Recurrence in Patients With Detectable ctDNA After Surgery in High-Risk Rectal Cancer","sponsor":"Erasmus Medical Center","started":"2025-10-14","startedType":"actual","enrolled":103,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05815082","kind":"trial","name":"ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer is a phase 3, randomised interventional study registered as NCT05815082 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 490 participants, started 2023-02-20 and due to reach its primary completion in 2031-02-20. Interventions recorded: Colorectal cancer resection combined with liver metastasis resection.; FOLFOX chemotherapy regimen. Conditions listed: Colorectal Cancer; Liver Metastases; Circulating Tumor Cell; Chemotherapy Effect. Primary outcome: 3-year progression-free survival; 5-year progression-free survival. Colorectal eligibility wording from the registry: \"Patients with liver metastatic colorectal cancer who have achieved R0 resection according to MDT evaluation (including patients with metastases treated with ablation therapy that achieved similar R0 resection effects);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05815082","url":"https://clinicaltrials.gov/study/NCT05815082"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05815082","phase":"3","setting":"ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer: A Prospective Multicenter Randomized Controlled Clinical Trial","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2023-02-20","startedType":"actual","enrolled":490,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07012954","kind":"trial","name":"ctDNA-Guided Cetuximab or Bevacizumab Plus Trifluridine/Tipiracil in RAS/BRAF Wild-Type mCRC","aka":[],"tldr":"A phase 1/2 trial of cetuximab, trifluridine/tipiracil and bevacizumab (glioblastoma use) in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"ctDNA-Guided Cetuximab or Bevacizumab Plus Trifluridine/Tipiracil in RAS/BRAF Wild-Type mCRC is a phase 1/2, randomised interventional study registered as NCT07012954 by Sun Yat-sen University, with a registry enrolment figure of 64 participants, started 2025-06-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: Cetuximab (Erbitux, C225); trifluridine/tipiracil; Bevacizumab ( Avastin). Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07012954","url":"https://clinicaltrials.gov/study/NCT07012954"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","mrd-testing"],"targets":[],"drugs":["cetuximab","trifluridine-tipiracil","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07012954","phase":"1/2","setting":"ctDNA-Guided Rechallenge With Cetuximab Plus Trifluridine/Tipiracil Versus Bevacizumab Plus Trifluridine/Tipiracil for RAS/BRAF Wild-Type Refractory Metastatic Colorectal Cancer: A Randomized Clinical Trial","sponsor":"Sun Yat-sen University","started":"2025-06-01","startedType":"actual","enrolled":64,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06609551","kind":"trial","name":"ctDNA-guided Selection of Adjuvant Chemotherapy Regimens for Elderly Colon Cancer Patients After Surgery: A Single-center, Randomized, Controlled Study","aka":["ZJCH-CRCC-1"],"tldr":"A phase 3 trial in colorectal cancer, run by Zhejiang Cancer Hospital, now recruiting.","summary":"ctDNA-guided Selection of Adjuvant Chemotherapy Regimens for Elderly Colon Cancer Patients After Surgery: A Single-center, Randomized, Controlled Study is a phase 3, randomised interventional study registered as NCT06609551 by Zhejiang Cancer Hospital, with a registry enrolment figure of 312 participants, started 2024-07-03 and due to reach its primary completion in 2029-12-31. Interventions recorded: 6-month adjuvant chemotherapy with 5-FU monotherapy; XELOX intensive treatment group. Conditions listed: Colon Cancer; Colon Cancer (Stage II &Amp;Amp;Amp; III). Primary outcome: 2-year DFS (Disease-Free Survival). Colorectal eligibility wording from the registry: \"Patients with histopathologically confirmed stage II high-risk or stage III colon cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06609551","url":"https://clinicaltrials.gov/study/NCT06609551"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06609551","phase":"3","setting":"ctDNA-guided Selection of Adjuvant Chemotherapy Regimens for Elderly Colon Cancer Patients After Surgery: A Single-center, Randomized, Controlled Study","sponsor":"Zhejiang Cancer Hospital","started":"2024-07-03","startedType":"actual","enrolled":312,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07209215","kind":"trial","name":"ctDNA-Informed Management of Early-Stage Rectal Cancer","aka":["ULTIMATE"],"tldr":"A phase 2 trial in colorectal cancer, run by University of California, Davis, not yet recruiting.","summary":"ctDNA-Informed Management of Early-Stage Rectal Cancer is a phase 2, interventional study registered as NCT07209215 by University of California, Davis, with a registry enrolment figure of 200 participants, started 2026-10 and due to reach its primary completion in 2028-05. Interventions recorded: Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT). Conditions listed: Rectal Adenocarcinoma; Rectal Cancer; Early-stage Rectal Cancer; Locally Advanced Rectal Adenocarcinoma. Primary outcome: Pathologic complete response (pathCR) rate (ctDNA Informed Management Arm); Pathologic complete response (pathCR) rate (Post TNT SOC Surgery Arm); Disease-free survival (DFS) rate (ctDNA Informed Management Arm). Colorectal eligibility wording from the registry: \"* Tumor tissue histologically confirming rectal adenocarcinoma that is available for Natera ctDNA assay\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07209215","url":"https://clinicaltrials.gov/study/NCT07209215"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07209215","phase":"2","setting":"ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE)","sponsor":"University of California, Davis","started":"2026-10","startedType":"estimated","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06951646","kind":"trial","name":"ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immunotherapy (CR1STAL-Adaptive)","aka":[],"tldr":"A phase 2 trial of ivonescimab and docetaxel in lung cancer, run by Second Xiangya Hospital of Central South University, now recruiting.","summary":"ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immunotherapy (CR1STAL-Adaptive) is a phase 2, randomised interventional study registered as NCT06951646 by Second Xiangya Hospital of Central South University, with a registry enrolment figure of 70 participants, started 2026-03-10 and due to reach its primary completion in 2028-07-01. Interventions recorded: Ivonescimab; Docetaxel; Standard Treatment group. Conditions listed: Non Small Cell Lung Cancer; Immune Checkpoint Inhibitors (ICIs). Primary outcome: Progression-Free Survival (PFS) in ctDNA-Positive Population. Lung eligibility wording from the registry: \"Patients with stage IIIB-IIIC and IV non-small cell lung cancer confirmed by histology or cytology that cannot be treated locally (TNM lung cancer staging of the 9th edition of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06951646","url":"https://clinicaltrials.gov/study/NCT06951646"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","bispecific-antibody","checkpoint-inhibitor","cytotoxic-chemotherapy","mrd-testing"],"targets":[],"drugs":["ivonescimab","docetaxel"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06951646","phase":"2","setting":"ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immunotherapy: a Randomized, Open-label, Phase II Trial (CR1STAL-Adaptive)","sponsor":"Second Xiangya Hospital of Central South University","started":"2026-03-10","startedType":"estimated","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06548412","kind":"trial","name":"CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers","aka":[],"tldr":"A phase 1/2 trial of durvalumab, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by M.D. Anderson Cancer Center, now recruiting.","summary":"CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers is a phase 1/2, randomised interventional study registered as NCT06548412 by M.D. Anderson Cancer Center, with a registry enrolment figure of 50 participants, started 2025-01-22 and due to reach its primary completion in 2027-05-01. Interventions recorded: Gemcitabine, Cisplatin, Durvalumab, CTX-009. Conditions listed: Metastatic Biliary Tract Cancer. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06548412","url":"https://clinicaltrials.gov/study/NCT06548412"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["durvalumab","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06548412","phase":"1/2","setting":"CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers","sponsor":"M.D. Anderson Cancer Center","started":"2025-01-22","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"cupisco","kind":"trial","name":"CUPISCO","aka":["CUPISCO trial"],"tldr":"CUPISCO was the first randomised test of precision medicine in cancer of unknown primary, where doctors cannot see where the cancer started. After three rounds of chemotherapy, switching to a drug chosen from the tumour's genetic profile held the cancer back for longer than carrying on with chemotherapy.","summary":"CUPISCO opened in July 2018 across more than 30 countries. Patients with newly diagnosed, unfavourable-subset cancer of unknown primary received three cycles of platinum-based chemotherapy; those whose disease was controlled were randomised three to one between molecularly guided therapy and continued chemotherapy. Tumour tissue and plasma were profiled with Foundation Medicine's assays and a molecular tumour board assigned each patient in the experimental arm to one of the trial's targeted or immunotherapy options: atezolizumab (alone or with chemotherapy), alectinib, entrectinib, erlotinib, vemurafenib with cobimetinib, vismodegib, trastuzumab emtansine, pertuzumab with trastuzumab, olaparib or ipatasertib, or to atezolizumab-based therapy where no alteration was targetable.\n\nAlwin Krämer and colleagues reported the primary analysis in the Lancet in 2024. Progression-free survival, the primary endpoint, was longer with molecularly guided therapy: median 6.1 months against 4.4 months with continued chemotherapy, a hazard ratio of 0.72, and the benefit was clearest in patients with an alteration that matched one of the targeted drugs. Overall survival data were immature, and the experimental arm was heterogeneous, so the trial establishes the strategy rather than any single drug.\n\nCUPISCO's practical effect is to give comprehensive genomic profiling a randomised evidence base in a disease where guidelines had recommended it on faith, and to shift the standard first question in unfavourable cancer of unknown primary from tissue of origin to targetable alteration. What remains open is whether the modest progression-free gain translates into survival, how to sequence profiling so that results arrive before chemotherapy stops working, and whether the approach holds outside a trial with a dedicated molecular tumour board.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03498521","url":"https://clinicaltrials.gov/study/NCT03498521"},{"label":"Krämer et al., Lancet 2024: molecularly guided therapy versus chemotherapy after disease control in unfavourable cancer of unknown primary (CUPISCO)","url":"https://doi.org/10.1016/S0140-6736(24)00814-6"}],"tags":[],"related":[],"cancers":["cancer-of-unknown-primary","cup-unfavourable"],"sections":[],"technologies":["cgp","liquid-biopsy","checkpoint-inhibitor","kinase-inhibitors","parp-inhibitor"],"targets":[],"drugs":["atezolizumab","alectinib","entrectinib","erlotinib","vemurafenib","cobimetinib","vismodegib","trastuzumab-emtansine","pertuzumab","trastuzumab","olaparib","ipatasertib","carboplatin","cisplatin","paclitaxel","gemcitabine"],"companies":["roche-genentech","foundation-medicine"],"institutions":[],"pathways":[],"terms":["master-protocol","basket-umbrella-platform","pfs"],"trials":[],"people":["linda-mileshkin"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03498521","phase":"2","setting":"Newly diagnosed unfavourable cancer of unknown primary controlled by three cycles of platinum chemotherapy: randomised to molecularly guided therapy chosen from tissue and blood genomic profiling, or to continued chemotherapy","sponsor":"F. Hoffmann-La Roche","result":"Median progression-free survival 6.1 months with molecularly guided therapy versus 4.4 months with continued chemotherapy (hazard ratio 0.72); overall survival immature.","started":"2018-07-10","startedType":"actual","yearReported":2024,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Molecularly guided therapy","value":6.1},{"name":"Continued chemotherapy","value":4.4}],"hr":0.72,"source":"https://doi.org/10.1016/S0140-6736(24)00814-6"}]},{"id":"nct06659705","kind":"trial","name":"Cutting Edge Imaging With PET-FAPI for Earlier Pancreatic Cancer Diagnosis (INDIGO-FAPI)","aka":["INDIGO-FAPI"],"tldr":"A phase 2 trial in pancreatic cancer, run by Institut Curie, now recruiting.","summary":"Cutting Edge Imaging With PET-FAPI for Earlier Pancreatic Cancer Diagnosis (INDIGO-FAPI) is a phase 2, interventional study registered as NCT06659705 by Institut Curie, with a registry enrolment figure of 35 participants, started 2025-12-02 and due to reach its primary completion in 2029-08-04. Interventions recorded: 68Ga-FAPI-46 for PET / CT scan. Conditions listed: Pancreatic Ductal Adenocarcinoma (PDAC). Primary outcome: EFS: Event Free Survival. Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06659705","url":"https://clinicaltrials.gov/study/NCT06659705"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06659705","phase":"2","setting":"Cutting Edge Imaging for Earlier Pancreatic Cancer Diagnosis: Evaluation of Positron Emission Tomography (PET) With the Fibroblast Activation Protein Inhibitor (FAPI)","sponsor":"Institut Curie","started":"2025-12-02","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05257590","kind":"trial","name":"CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma","aka":[],"tldr":"A phase 2 trial of Nivolumab in hepatocellular carcinoma and metastatic cancer, run by TaiRx, Inc., now recruiting.","summary":"CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma is a phase 2 interventional study registered as NCT05257590 by TaiRx, Inc., with 95 participants planned, started 2022-05-23 and due to reach its primary completion in 2026-12-31. Interventions recorded: Nivolumab Injection [Opdivo], CVM-1118. Conditions listed: Hepatocellular Carcinoma, Advanced Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05257590","url":"https://clinicaltrials.gov/study/NCT05257590"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","metastatic-cancer","hcc-advanced"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["tairx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05257590","phase":"2","setting":"A Phase 2, Open-Label Study of CVM-1118 in Combination With Nivolumab in Subjects With Unresectable Advanced Hepatocellular Carcinoma","sponsor":"TaiRx, Inc.","started":"2022-05-23","startedType":"actual","enrolled":95,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07664150","kind":"trial","name":"CW-301 FIH Study of CAN016","aka":[],"tldr":"A phase 1/2 trial of CAN016 in advanced solid tumours, run by Canwell Biotech Limited, now recruiting.","summary":"CW-301 FIH Study of CAN016 is a phase 1/2 interventional study registered as NCT07664150 by Canwell Biotech Limited, with 90 participants planned, started 2026-06-18 and due to reach its primary completion in 2028-12-30. Interventions recorded: CAN016.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07664150","url":"https://clinicaltrials.gov/study/NCT07664150"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07664150","phase":"1/2","setting":"A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients With Advanced Solid Tumors","sponsor":"Canwell Biotech Limited","started":"2026-06-18","startedType":"estimated","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05067530","kind":"trial","name":"Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a \"Window of Opportunity\" Study","aka":["CAREGIVER"],"tldr":"A phase 2 trial of palbociclib, paclitaxel / nab-paclitaxel and carboplatin in triple-negative breast cancer, run by Medical University of Gdansk, not yet recruiting.","summary":"Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a \"Window of Opportunity\" Study is a phase 2, randomised interventional study registered as NCT05067530 by Medical University of Gdansk, with a registry enrolment figure of 126 participants, started 2022-01-01 and due to reach its primary completion in 2025-01-01. Interventions recorded: Palbociclib; Paclitaxel; Carboplatin. Conditions listed: Triple Negative Breast Neoplasms. Triple-negative eligibility wording from the registry: \"* triple negative tumor defined as:\". Sites: Poland. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05067530","url":"https://clinicaltrials.gov/study/NCT05067530"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["palbociclib","paclitaxel","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05067530","phase":"2","setting":"Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a \"Window of Opportunity\" Study","sponsor":"Medical University of Gdansk","started":"2022-01-01","startedType":"estimated","enrolled":126,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06434909","kind":"trial","name":"CYTALUX™for the Intraoperative Imaging of Prostate Cancer","aka":[],"tldr":"A phase 2 trial of Pafolacianine in Prostate cancer, run by Indiana University, completed.","summary":"CYTALUX™for the Intraoperative Imaging of Prostate Cancer is a phase 2 interventional study registered as NCT06434909 by Indiana University, with 9 participants recorded, started 2024-09-19 and reaching its primary completion in 2025-09-04. Interventions recorded: Cytalux™ (pafolacianine) for fluorescent imaging, Image Guided Surgery. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Pafolacianine because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06434909","url":"https://clinicaltrials.gov/study/NCT06434909"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["pafolacianine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06434909","phase":"2","setting":"An Investigator Sponsored Study to Investigate the Safety and Efficacy of CYTALUX™ (PAFOLACIANINE) INJECTION for the Intraoperative Imaging of Prostate Cancer","sponsor":"Indiana University","started":"2024-09-19","startedType":"actual","enrolled":9,"enrolledBasis":"registry","outcomes":[]},{"id":"cyto-pv","kind":"trial","name":"CYTO-PV","aka":[],"tldr":"CYTO-PV settled the most basic question in PV: keeping the haematocrit under 45 percent gives far fewer serious clots and cardiovascular deaths than a looser target.","summary":"CYTO-PV randomised 365 adults with polycythaemia vera to a haematocrit target below 45 percent or between 45 and 50 percent, achieved with phlebotomy and hydroxyurea. After a median of 31 months the primary endpoint of cardiovascular death or major thrombosis occurred in 2.7 percent of the low-target group and 9.8 percent of the high-target group (Marchioli and colleagues, New England Journal of Medicine 2013). The result made 45 percent the universal target.","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01645124","url":"https://clinicaltrials.gov/study/NCT01645124"},{"label":"NEJM 2013","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1208500"}],"tags":["polycythaemia-vera","mpn"],"related":[],"cancers":["polycythaemia-vera","myeloproliferative-neoplasms"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["hydroxyurea","phosphorus-32"],"companies":["gimema"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01645124","phase":"3","setting":"Polycythaemia vera: haematocrit target below 45 percent versus 45 to 50 percent","sponsor":"GIMEMA (Gruppo Italiano Malattie Ematologiche dell'Adulto)","result":"Cardiovascular death or major thrombosis 2.7% vs 9.8% (hazard ratio 3.91 for the higher target).","started":"2008-05","yearReported":2013,"enrolled":365,"enrolledBasis":"registry","outcomes":[{"endpoint":"Cardiovascular death or major thrombosis","primary":true,"unit":"%","arms":[{"name":"Haematocrit below 45%","n":182,"value":2.7},{"name":"Haematocrit 45 to 50%","n":183,"value":9.8}]}]},{"id":"nct06300177","kind":"trial","name":"D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standar","aka":[],"tldr":"A phase 3 trial of Garsorasib, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., now recruiting.","summary":"D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standard Therapy Failure is a phase 3 interventional study registered as NCT06300177 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with 522 participants planned, started 2024-03-28 and due to reach its primary completion in 2026-10. Interventions recorded: D-1553 Tablet, Docetaxel injection. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06300177","url":"https://clinicaltrials.gov/study/NCT06300177"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","kras-g12c-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","kras-inhibitors"],"targets":[],"drugs":["garsorasib","docetaxel"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06300177","phase":"3","setting":"A Randomized, Controlled, Double-blind, Double-simulated, Multicenter Phase III Clinical Study Evaluating D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standard Therapy Failure.","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2024-03-28","startedType":"actual","enrolled":522,"enrolledBasis":"registry","outcomes":[]},{"id":"d-alba","kind":"trial","name":"D-ALBA (GIMEMA LAL2116)","aka":[],"tldr":"The trial that showed Ph-positive ALL can be treated with a pill plus an immunotherapy and no chemotherapy, with 95% of patients alive at 18 months.","summary":"63 patients (median age 54): molecular response 60% after two blinatumomab cycles rising with further cycles; 18-month OS 95%, DFS 88%; only half went to transplant. NEJM 2020. Four-year update: OS ~80%, DFS ~75%, with IKZF1-plus and T315I relapses. Successor trials (GIMEMA ALL2820 with ponatinib) and MD Anderson ponatinib-blinatumomab series extend the chemotherapy-free approach.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02744768","url":"https://clinicaltrials.gov/study/NCT02744768"},{"label":"NEJM 2020","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2016272"}],"tags":[],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["bcr-abl","cd19"],"drugs":["dasatinib","blinatumomab"],"companies":["gimema"],"institutions":[],"pathways":[],"terms":["ph-positive-all"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02744768","phase":"2","setting":"Newly diagnosed Ph-positive ALL, adults of all ages: dasatinib induction followed by blinatumomab, no systemic chemotherapy","sponsor":"GIMEMA","result":"18-month OS 95%, DFS 88%.","started":"2017-05-31","startedType":"actual","yearReported":2020,"enrolled":63,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 18 months","unit":"%","arms":[{"name":"Dasatinib → blinatumomab","n":63,"value":95}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2016272"},{"endpoint":"Disease-free survival at 18 months","primary":true,"unit":"%","arms":[{"name":"Dasatinib → blinatumomab","value":88}],"source":"https://doi.org/10.1056/NEJMoa2016272"}],"replication":"MD Anderson ponatinib + blinatumomab phase 2 (Jabbour et al.) reproduced near-universal molecular remission without chemotherapy; randomised confirmation (GIMEMA ALL2820, EWALL) pending."},{"id":"nct07016126","kind":"trial","name":"D-BACE in Combination With Chemotherapy and Carelizumab for Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLC","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Guangdong Provincial People's Hospital, now recruiting.","summary":"D-BACE in Combination With Chemotherapy and Carelizumab for Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLC is a phase 3, interventional study registered as NCT07016126 by Guangdong Provincial People's Hospital, with a registry enrolment figure of 70 participants, started 2024-12-22 and due to reach its primary completion in 2027-12-22. Interventions recorded: D-BACE in combination with chemotherapy and karelizumab. Conditions listed: NSCLC (Non-small Cell Lung Cancer). Primary outcome: Evaluation of the pCR of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumab. Lung eligibility wording from the registry: \"It is recommended that fresh tissue be fixed in 10% neutral buffered formalin for 24 to 48 hours The patient's lung function or other organ function was evaluated by the surgeon to tolerate local surgical treatment\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07016126","url":"https://clinicaltrials.gov/study/NCT07016126"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07016126","phase":"3","setting":"D-BACE in Combination With Chemotherapy and Carelizumab for Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLC","sponsor":"Guangdong Provincial People's Hospital","started":"2024-12-22","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06622057","kind":"trial","name":"D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 3 trial testing D07001 in biliary tract cancer, now recruiting.","summary":"D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer is a phase 3 interventional study registered as NCT06622057, led by InnoPharmax, and recruiting on the registry. Official title: Phase III, Randomised, Double-blind Study of Combination Therapy With D07001-Softgel Capsules and Capecitabine vs Placebo and Capecitabine in Patients With Advanced BTC After Failed on Gemcitabine, Platin, and FOLFOX or Irinotecan Regimens. Planned enrolment is 240 participants (estimated). The study started in 2026-06-09 and primary completion is expected in 2028-12-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06622057","url":"https://clinicaltrials.gov/study/NCT06622057"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["d07001"],"companies":["innopharmax"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06622057","phase":"3","setting":"Phase III, Randomized, Double-blind Study of Combination Therapy With D07001-Softgel Capsules and Capecitabine vs Placebo and Capecitabine in Patients With Advanced BTC After Failed on Gemcitabine, Platin, and FOLFOX or Irinotecan Regimens","sponsor":"InnoPharmax","started":"2026-06-09","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04884360","kind":"trial","name":"D9319C00001- 1L OC Mono Global RCT","aka":["MONO-OLA1"],"tldr":"A phase 3 trial of Olaparib in ovarian cancer, run by AstraZeneca, active and no longer recruiting.","summary":"D9319C00001- 1L OC Mono Global RCT is a phase 3 interventional study registered as NCT04884360 by AstraZeneca, with 366 participants enrolled, started 2021-05-31 and due to reach its primary completion in 2026-07-27. Interventions recorded: Olaparib, Matching placebo. Conditions listed: Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04884360","url":"https://clinicaltrials.gov/study/NCT04884360"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["olaparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04884360","phase":"3","setting":"A Randomised, Double-blind, Placebo-controlled, Phase III Study of Olaparib Maintenance Monotherapy in Participants With BRCA Wild Type Advanced High Grade Serous or Endometrioid Ovarian Cancer Following Response to Standard First-line Platinum-based Chemotherapy (MONO-OLA1)","sponsor":"AstraZeneca","started":"2021-05-31","startedType":"actual","enrolled":366,"enrolledBasis":"registry","outcomes":[]},{"id":"dahanca-5","kind":"trial","name":"DAHANCA 5","aka":[],"tldr":"DAHANCA 5 is the trial that made hypoxic sensitisation real in the clinic: nimorazole with radiotherapy improved control of head and neck cancer, and Denmark has used it as standard ever since.","summary":"DAHANCA 5 randomised 422 patients with carcinoma of the supraglottic larynx or pharynx to nimorazole or placebo during conventional radiotherapy. Five-year locoregional control was 49 percent with nimorazole and 33 percent with placebo, with a survival advantage in the pharynx subgroup and minimal added toxicity (Overgaard and colleagues, Radiotherapy and Oncology 1998). A later analysis showed the benefit was confined to tumours with a hypoxic gene signature, and a European confirmatory trial (EORTC 1219) followed.","status":"positive","asOf":"2026-09-16","links":[{"label":"Radiotherapy and Oncology 1998","url":"https://doi.org/10.1016/S0167-8140(97)00220-X"}],"tags":["radiation-wave2"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":["radiosensitisers","tumour-hypoxia-modification"],"targets":[],"drugs":["nimorazole"],"companies":["dahanca"],"institutions":[],"pathways":[],"terms":["tumour-hypoxia"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-overgaard-radiother-oncol"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Supraglottic larynx and pharynx cancer treated with radiotherapy: the hypoxic radiosensitiser nimorazole versus placebo","sponsor":"Danish Head and Neck Cancer Group","result":"5-year locoregional control 49% (nimorazole) vs 33% (placebo).","yearReported":1998,"enrolled":422,"enrolledBasis":"registry","outcomes":[{"endpoint":"Locoregional control at 5 years","primary":true,"unit":"%","arms":[{"name":"Nimorazole plus radiotherapy","n":219,"value":49},{"name":"Placebo plus radiotherapy","n":203,"value":33}]}]},{"id":"nct07288879","kind":"trial","name":"DALY II Japan/MB-CART2019.1 for DLBCL","aka":["DALY II Japan"],"tldr":"A phase 2 trial of Zamtocabtagene autoleucel in diffuse large b-cell lymphoma, run by Miltenyi Biomedicine GmbH, now recruiting.","summary":"DALY II Japan/MB-CART2019.1 for DLBCL is a phase 2 interventional study registered as NCT07288879 by Miltenyi Biomedicine GmbH, with 31 participants planned, started 2025-12-11 and due to reach its primary completion in 2027-01-31. Interventions recorded: MB-CART2019.1. Conditions listed: DLBCL - Diffuse Large B Cell Lymphoma, CAR T Cell Therapy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07288879","url":"https://clinicaltrials.gov/study/NCT07288879"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["zamtocabtagene-autoleucel"],"companies":["miltenyi-biomedicine"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07288879","phase":"2","setting":"A Multi-center Single Arm Phase II Study to Evaluate the Safety and Efficacy of Genetically Engineered Autologous Cells Expressing Anti-CD20 and Anti-CD19 Specific Chimeric Antigen Receptor in Subjects With Relapsed and/or Refractory Diffuse Large B Cell Lymphoma.","sponsor":"Miltenyi Biomedicine GmbH","started":"2025-12-11","startedType":"actual","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04792489","kind":"trial","name":"DALY II USA/ MB-CART2019.1 for DLBCL","aka":[],"tldr":"A phase 2 trial of Zamtocabtagene autoleucel, Cyclophosphamide, Fludarabine in diffuse large b-cell lymphoma and mantle cell lymphoma, run by Miltenyi Biomedicine GmbH, now recruiting.","summary":"DALY II USA/ MB-CART2019.1 for DLBCL is a phase 2 interventional study registered as NCT04792489 by Miltenyi Biomedicine GmbH, with 315 participants planned, started 2021-05-25 and due to reach its primary completion in 2026-12-31. Interventions recorded: zamtocabtagene autoleucel (MB-CART2019.1), Cyclophosphamide, Fludarabine, Bendamustine. Conditions listed: Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B Cell Lymphoma, High Grade B-cell Lymphoma (HGBCL), Primary Mediastinal B-cell Lymphoma (PMBCL). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04792489","url":"https://clinicaltrials.gov/study/NCT04792489"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl","mantle-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["zamtocabtagene-autoleucel","cyclophosphamide","fludarabine","bendamustine"],"companies":["miltenyi-biomedicine"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04792489","phase":"2","setting":"A Multi-center Single Arm Phase II Study to Evaluate the Safety and Efficacy of Genetically Engineered Autologous Cells Expressing Anti-CD20 and Anti-CD19 Specific Chimeric Antigen Receptor in Subjects With Relapsed and/or Refractory Diffuse Large B Cell Lymphoma","sponsor":"Miltenyi Biomedicine GmbH","started":"2021-05-25","startedType":"actual","enrolled":315,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07472517","kind":"trial","name":"DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment","aka":[],"tldr":"A phase 3 trial of Atezolizumab, Carboplatin, Etoposide in small-cell lung cancer, run by Boehringer Ingelheim, now recruiting.","summary":"DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemoimmunotherapy is a phase 3 interventional study registered as NCT07472517 by Boehringer Ingelheim, with 670 participants planned, started 2026-04-13 and due to reach its primary completion in 2028-09-09. Interventions recorded: obrixtamig, atezolizumab, carboplatin, etoposide. Conditions listed: Small Cell Lung Cancer (SCLC), Extensive-stage Small Cell Lung Cancer (ES-SCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07472517","url":"https://clinicaltrials.gov/study/NCT07472517"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["atezolizumab","carboplatin","etoposide","obrixtamig"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07472517","phase":"3","setting":"DAREON ® -Lung-1: A Phase III Multi-center, Open-label, Randomised Trial of Intravenous Obrixtamig in Combination With Atezolizumab, Carboplatin, and Etoposide vs. Atezolizumab, Carboplatin, and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer","sponsor":"Boehringer Ingelheim","started":"2026-04-13","startedType":"actual","enrolled":670,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07707895","kind":"trial","name":"DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers","aka":[],"tldr":"A phase 1/2 trial of obrixtamig, ZL-1310 and atezolizumab in lung cancer, run by Boehringer Ingelheim, not yet recruiting.","summary":"DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers is a phase 1/2, interventional study registered as NCT07707895 by Boehringer Ingelheim, with a registry enrolment figure of 60 participants, started 2026-09-29 and due to reach its primary completion in 2030-04-26. Interventions recorded: Obrixtamig; ZL-1310; Atezolizumab. Conditions listed: Small Cell Lung Cancer; Large Cell Neuroendocrine Lung Carcinoma; Extrapulmonary Neuroendocrine Carcinoma of Small Cell Histology; Extrapulmonary Neuroendocrine Carcinoma of Large Cell Histology. Primary outcome: Part 1: The occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period; Part 2: The occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation or dose modification; Part 2: PFS rate at 6 months. Lung eligibility wording from the registry: \"* Small cell lung carcinoma (SCLC)\". Sites: Australia, Belgium, China, France, Germany, Japan, Netherlands, Poland, Spain, United Kingdom, United States. United Kingdom sites listed: 2. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07707895","url":"https://clinicaltrials.gov/study/NCT07707895"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["obrixtamig","zl-1310","atezolizumab"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Leicester Royal Infirmary (Leicester); Freeman Hospital (Newcastle upon Tyne)."],"nct":"NCT07707895","phase":"1/2","setting":"A Phase Ib/II, Open-label, Safety and Tolerability Trial of Obrixtamig in Combination With ZL-1310 in Patients With Poorly Differentiated NEC","sponsor":"Boehringer Ingelheim","started":"2026-09-29","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07544654","kind":"trial","name":"DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy","aka":[],"tldr":"A phase 3 trial of Carboplatin and Etoposide in neuroendocrine tumours, run by Boehringer Ingelheim, now recruiting.","summary":"DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy is a phase 3 interventional study registered as NCT07544654 by Boehringer Ingelheim, with 390 participants planned, started 2026-07-10 and due to reach its primary completion in 2029-12-13. Interventions recorded: Obrixtamig, Carboplatin, Etoposide and Ventana DLL3 RxDx assay.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07544654","url":"https://clinicaltrials.gov/study/NCT07544654"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine","extrapulmonary-nec"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["carboplatin","etoposide","obrixtamig"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07544654","phase":"3","setting":"A Phase III, Multi-center, Open-label, Randomised, Controlled Trial of Intravenous Obrixtamig in Combination With Carboplatin and Etoposide vs. Carboplatin and Etoposide as First-line Therapy in DLL3-positive Patients With Unresectable Locally Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas","sponsor":"Boehringer Ingelheim","started":"2026-07-10","startedType":"actual","enrolled":390,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05882058","kind":"trial","name":"DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers","aka":[],"tldr":"A phase 2 trial of BI 764532, dose 1 in small-cell lung cancer and neuroendocrine tumours, run by Boehringer Ingelheim, now recruiting.","summary":"DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers is a phase 2 interventional study registered as NCT05882058 by Boehringer Ingelheim, with 204 participants planned, started 2023-10-13 and due to reach its primary completion in 2027-12-17. Interventions recorded: BI 764532, dose 1, BI 764532, dose 2 and Ventana DLL3 RxDx assay.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05882058","url":"https://clinicaltrials.gov/study/NCT05882058"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","neuroendocrine","extrapulmonary-nec","extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["obrixtamig"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05882058","phase":"2","setting":"DAREON™-5: An Open-label, Multi-center Phase II Dose Selection Trial of Intravenous BI 764532, a DLL3-targeting T Cell Engager, in Patients With Relapsed/Refractory Extensive-stage Small Cell Lung Cancer and in Patients With Other Relapsed/Refractory Neuroendocrine Carcinomas","sponsor":"Boehringer Ingelheim","started":"2023-10-13","startedType":"actual","enrolled":204,"enrolledBasis":"registry","outcomes":[]},{"id":"dart-s1609","kind":"trial","name":"DART (SWOG S1609): nivolumab plus ipilimumab in rare tumours","aka":["DART","S1609","Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors"],"tldr":"DART gives the same two immunotherapy drugs to people with dozens of different rare cancers, each cancer in its own small group, so that rare diseases nobody would build a trial for get an answer. It found real responses in high-grade neuroendocrine cancers and in angiosarcoma.","summary":"DART opened in January 2017 under SWOG for the NCI, co-led by Sandip Patel and Razelle Kurzrock, and is the largest immunotherapy basket in rare cancers, with more than 50 histology cohorts and close to 800 patients. Every cohort receives nivolumab with low-dose ipilimumab, and each is analysed separately for objective response with a two-stage rule, so an unpromising histology stops after the first stage while a promising one expands.\n\nThe first cohort to report, in Clinical Cancer Research in 2020, was neuroendocrine tumours: a quarter of patients responded, with responses concentrated in high-grade disease and none in low-grade tumours, which changed how oncologists think about immunotherapy in neuroendocrine carcinoma. Angiosarcoma followed in 2021 with responses in about a quarter of patients, strikingly in cutaneous tumours of the scalp and face. Other cohorts, including several sarcoma and gynaecological histologies, have reported little activity, and the trial has published analyses of tumour mutational burden and other correlates across cohorts.\n\nDART is the practical proof that a basket run through the NCI's community oncology network can recruit rare cancers quickly, and its positive cohorts have entered guidelines as options where nothing else exists. What remains open is whether cohorts of 20 to 30 patients without a control can carry regulatory weight, and which rare histologies deserve a confirmatory trial.","status":"active","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02834013","url":"https://clinicaltrials.gov/study/NCT02834013"},{"label":"Patel et al., Clinical Cancer Research 2020: a phase II basket trial of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART SWOG 1609), neuroendocrine cohort","url":"https://doi.org/10.1158/1078-0432.CCR-19-3356"}],"tags":[],"related":[],"cancers":["rare-cancers","neuroendocrine","extrapulmonary-nec","vascular-tumours"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":["swog"],"institutions":["nci"],"pathways":[],"terms":["master-protocol","basket-umbrella-platform","tmb"],"trials":[],"people":["razelle-kurzrock"],"bottlenecks":["b-rare-cancers"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02834013","phase":"2","setting":"More than 50 cohorts of rare solid tumours with no standard therapy: nivolumab plus ipilimumab in a single-arm basket run across the NCI's community network","sponsor":"National Cancer Institute and SWOG Cancer Research Network","result":"Neuroendocrine cohort: about one in four responded, concentrated in high-grade disease; angiosarcoma cohort about one in four, mostly cutaneous scalp and face tumours; many other cohorts inactive.","started":"2017-01-30","startedType":"actual","yearReported":2020,"enrolledBasis":"registry","outcomes":[]},{"id":"dart-01-05-gicor","kind":"trial","name":"DART 01/05 GICOR","aka":["DART01/05","DART 01/05 GICOR"],"tldr":"Even when the radiation dose is pushed high, two more years of hormone therapy still improves survival for men with high-risk prostate cancer.","summary":"DART 01/05 GICOR tested whether escalating the radiation dose removes the need for long androgen deprivation. It randomised 355 men at ten Spanish university hospitals to 4 months of neoadjuvant and concomitant androgen deprivation with high-dose three-dimensional conformal radiotherapy of at least 76 Gy (range 76 to 82 Gy), or the same followed by 24 months of adjuvant androgen deprivation. Anti-androgen therapy, flutamide 750 mg or bicalutamide 50 mg daily, was added during the first 2 months.\n\nAt a median 63 months, 5-year biochemical disease-free survival was 90 percent (95 percent confidence interval 87 to 92) with long-course treatment against 81 percent (78 to 85) with short-course, hazard ratio 1.88 (1.12 to 3.15, p=0.01). Five-year overall survival was 95 percent (93 to 97) against 86 percent (83 to 89), hazard ratio 2.48 (1.31 to 4.68, p=0.009), and 5-year metastasis-free survival 94 percent (92 to 96) against 83 percent (80 to 86), hazard ratio 2.31 (1.23 to 3.85, p=0.01). The effect was more evident in high-risk than in lower-risk men.\n\nLate toxicity did not differ: grade 3 late rectal toxicity in three of 177 long-course and two of 178 short-course men, grade 3 to 4 late urinary toxicity in five men in each group, and no treatment-related deaths. The authors were explicit that longer follow-up is needed before concluding that intermediate-risk men benefit from more than 4 months.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02175212","url":"https://clinicaltrials.gov/study/NCT02175212"},{"label":"DART 01/05 GICOR (Lancet Oncology 2015)","url":"https://doi.org/10.1016/S1470-2045(15)70045-8"}],"tags":[],"related":[],"cancers":["prostate","prostate-intermediate-risk","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation","imrt-igrt"],"targets":[],"drugs":["goserelin","flutamide","bicalutamide"],"companies":[],"institutions":[],"pathways":[],"terms":["adt","hormone-therapy","curative-intent"],"trials":["rtog-9202","eortc-22961","eortc-22991"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02175212","phase":"3","setting":"Clinical stage T1c to T3b N0 M0 prostate adenocarcinoma with intermediate-risk or high-risk factors: 4 months of androgen deprivation with high-dose three-dimensional conformal radiotherapy of at least 76 Gy, with or without 24 further months of adjuvant androgen deprivation, with biochemical disease-free survival as the primary endpoint","sponsor":"Grupo de Investigacion Clinica en Oncologia Radioterapica (GICOR), Spain","result":"Five-year overall survival 95 against 86 percent (hazard ratio 2.48, 95 percent confidence interval 1.31 to 4.68) and biochemical disease-free survival 90 against 81 percent (1.88, 1.12 to 3.15) with 24 extra months of androgen deprivation after high-dose radiotherapy.","started":"2005-11","yearReported":2015,"enrolled":355,"enrolledBasis":"randomised","enrolledNote":"355 men were randomised between November 2005 and December 2010, 178 to short-course and 177 to long-course androgen deprivation.","outcomes":[{"endpoint":"Biochemical disease-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Long-course androgen deprivation, 28 months total","n":177,"value":90,"note":"Hazard ratio is for failure with short-course treatment."},{"name":"Short-course androgen deprivation, 4 months","n":178,"value":81}],"hr":1.88,"ci":[1.12,3.15],"p":"0.01","source":"https://doi.org/10.1016/S1470-2045(15)70045-8"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Long-course androgen deprivation, 28 months total","n":177,"value":95},{"name":"Short-course androgen deprivation, 4 months","n":178,"value":86}],"hr":2.48,"ci":[1.31,4.68],"p":"0.009","source":"https://doi.org/10.1016/S1470-2045(15)70045-8"}],"replication":"Consistent with RTOG 92-02 and EORTC 22961, both of which found long-course androgen deprivation better, and both of which used lower radiation doses."},{"id":"dasision","kind":"trial","name":"DASISION","aka":[],"tldr":"DASISION showed that the second-generation drug dasatinib brought chronic myeloid leukaemia under control faster and more deeply than imatinib when used from diagnosis, though after five years patients lived equally long on either.","summary":"DASISION randomised 519 patients with newly diagnosed chronic-phase chronic myeloid leukaemia to dasatinib 100 mg once daily or imatinib 400 mg once daily. The primary endpoint was confirmed complete cytogenetic response by 12 months.\n\nDasatinib produced higher rates of complete cytogenetic and major molecular response at 12 months, and responses came sooner, which led to its first-line approval in 2010. With five years of follow-up the rates of progression to advanced phase were lower with dasatinib, but overall survival was the same in both arms, and pleural effusions were commoner with dasatinib. Together with ENESTnd (nilotinib) and BFORE (bosutinib), it established that second-generation inhibitors give faster, deeper responses without a survival advantage, which is why imatinib remains a reasonable first choice for many patients.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00481247","url":"https://clinicaltrials.gov/study/NCT00481247"}],"tags":["subtype-trials"],"related":[],"cancers":["cml-chronic-phase","cml"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["dasatinib","imatinib"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["hagop-kantarjian"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00481247","phase":"3","setting":"Newly diagnosed chronic-phase chronic myeloid leukaemia: dasatinib 100 mg daily against imatinib 400 mg daily","sponsor":"Bristol Myers Squibb","result":"Dasatinib produced higher confirmed complete cytogenetic and major molecular response rates at 12 months than imatinib, with no difference in five-year overall survival.","started":"2007-09","yearReported":2010,"enrolled":547,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed complete cytogenetic response by 12 months","primary":true,"unit":"%","arms":[{"name":"Dasatinib 100 mg","n":259,"value":77},{"name":"Imatinib 400 mg","n":260,"value":66}],"p":"0.007","source":"https://doi.org/10.1056/nejmoa1002315"},{"endpoint":"Major molecular response by 12 months","unit":"%","arms":[{"name":"Dasatinib 100 mg","n":259,"value":46},{"name":"Imatinib 400 mg","n":260,"value":28}],"p":"<0.0001","source":"https://doi.org/10.1056/nejmoa1002315"},{"endpoint":"Progression to accelerated or blast phase","unit":"%","arms":[{"name":"Dasatinib 100 mg","n":259,"value":1.9},{"name":"Imatinib 400 mg","n":260,"value":3.5}],"source":"https://doi.org/10.1056/nejmoa1002315"}]},{"id":"nct06176261","kind":"trial","name":"DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs","aka":["DATO-BASE"],"tldr":"A phase 2 trial of datopotamab deruxtecan in triple-negative breast cancer, run by Nancy Lin, MD, now recruiting.","summary":"DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs is a phase 2, interventional study registered as NCT06176261 by Nancy Lin, MD, with a registry enrolment figure of 58 participants, started 2024-01-08 and due to reach its primary completion in 2028-01-01. Interventions recorded: Datopotamab Deruxtecan. Conditions listed: Breast Cancer; Breast Cancer Female; Metastatic Triple-Negative Breast Carcinoma; ER Positive Breast Cancer; HER2-negative Breast Cancer; HER2 Negative Breast Carcinoma; ER-negative Breast Cancer. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06176261","url":"https://clinicaltrials.gov/study/NCT06176261"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic","brain-metastases"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["datopotamab-deruxtecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06176261","phase":"2","setting":"DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs","sponsor":"Nancy Lin, MD","started":"2024-01-08","startedType":"actual","enrolled":58,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05555732","kind":"trial","name":"Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)","aka":["TROPION-Lung07"],"tldr":"A phase 3 trial of Datopotamab deruxtecan, Pembrolizumab, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by Daiichi Sankyo, active and no longer recruiting.","summary":"Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07) is a phase 3 interventional study registered as NCT05555732 by Daiichi Sankyo, with 1170 participants planned, started 2023-01-11 and due to reach its primary completion in 2029-05-11. Interventions recorded: Datopotamab Deruxtecan, Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin. Conditions listed: Metastatic Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05555732","url":"https://clinicaltrials.gov/study/NCT05555732"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan","pembrolizumab","pemetrexed","carboplatin","cisplatin"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05555732","phase":"3","setting":"A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in Subjects With No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07)","sponsor":"Daiichi Sankyo","started":"2023-01-11","startedType":"actual","enrolled":1170,"enrolledBasis":"registry","outcomes":[]},{"id":"dawna-1","kind":"trial","name":"DAWNA-1","aka":[],"tldr":"The trial that made dalpiciclib the first Chinese CDK4/6 inhibitor approved, more than doubling the time before breast cancer grew when added to fulvestrant.","summary":"361 patients randomised 2:1. Median progression-free survival 15.7 versus 7.2 months (hazard ratio 0.42), published in Nature Medicine 2021, with neutropenia the main toxicity. NMPA approval December 2021; DAWNA-2 (first line with an aromatase inhibitor) followed in 2023. It reproduced the PALOMA-3 and MONALEESA-3 pattern with a domestic, reimbursed drug.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03927456","url":"https://clinicaltrials.gov/study/NCT03927456"},{"label":"Nat Med 2021","url":"https://doi.org/10.1038/s41591-021-01562-9"}],"tags":["china"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":["cdk4-6"],"drugs":["dalpiciclib","fulvestrant"],"companies":["hengrui"],"institutions":["cams-cancer-hospital"],"pathways":[],"terms":[],"trials":[],"people":["xu-binghe"],"bottlenecks":[],"keyPapers":["paper-dawna-1-nat-med-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03927456","phase":"3","setting":"HR-positive, HER2-negative advanced breast cancer after progression on endocrine therapy, China: dalpiciclib or placebo plus fulvestrant","sponsor":"Jiangsu Hengrui Pharmaceuticals","result":"PFS 15.7 vs 7.2 months, HR 0.42.","started":"2019-06-13","startedType":"actual","yearReported":2021,"enrolled":361,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Dalpiciclib + fulvestrant","n":241,"value":15.7},{"name":"Placebo + fulvestrant","n":120,"value":7.2}],"hr":0.42,"source":"https://doi.org/10.1038/s41591-021-01562-9"}]},{"id":"nct05566795","kind":"trial","name":"DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)","aka":["FIREFLY-2"],"tldr":"A phase 3 trial of Tovorafenib in glioma & glioblastoma, run by Day One Biopharmaceuticals, Inc., active and no longer recruiting.","summary":"DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) is a phase 3 interventional study registered as NCT05566795 by Day One Biopharmaceuticals, Inc., with 418 participants enrolled, started 2023-02-27 and due to reach its primary completion in 2027-06. Interventions recorded: Tovorafenib and Chemotherapeutic Agent.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05566795","url":"https://clinicaltrials.gov/study/NCT05566795"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma","paediatric-low-grade-glioma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["tovorafenib"],"companies":["day-one-biopharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05566795","phase":"3","setting":"LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy","sponsor":"Day One Biopharmaceuticals, Inc.","started":"2023-02-27","startedType":"actual","enrolled":418,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06953089","kind":"trial","name":"DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors","aka":[],"tldr":"A phase 2 trial of BNT324 and PM8002 in advanced solid tumours, run by DualityBio Inc., now recruiting.","summary":"DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors is a phase 2 interventional study registered as NCT06953089 by DualityBio Inc., with 450 participants planned, started 2025-07-18 and due to reach its primary completion in 2030-06-30. Interventions recorded: DB-1311/BNT324, BNT327 and DB-1305/BNT325.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06953089","url":"https://clinicaltrials.gov/study/NCT06953089"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["bnt324","pm8002"],"companies":["dualitybio","biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06953089","phase":"2","setting":"A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors","sponsor":"DualityBio Inc.","started":"2025-07-18","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"dbcg-82bc","kind":"trial","name":"DBCG 82b and 82c","aka":[],"tldr":"The Danish postmastectomy trials proved that radiotherapy to the chest wall and nodes after mastectomy not only prevents local recurrence but saves lives in women with node-positive disease.","summary":"DBCG 82b randomised 1,708 premenopausal women with high-risk breast cancer to CMF chemotherapy with or without postmastectomy radiotherapy; 82c randomised 1,375 postmenopausal women to tamoxifen with or without radiotherapy. In 82b, ten-year locoregional recurrence fell from 32 to 9 percent and overall survival rose from 45 to 54 percent (Overgaard and colleagues, New England Journal of Medicine 1997); 82c showed the same pattern (Lancet 1999). Together with the British Columbia trial they established postmastectomy radiotherapy for node-positive disease.","status":"positive","asOf":"2026-09-17","links":[{"label":"NEJM 1997","url":"https://doi.org/10.1056/NEJM199710023371401"}],"tags":["radiation-wave4"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["cyclophosphamide","methotrexate","fluorouracil","tamoxifen"],"companies":["dbcg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-overgaard-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"High-risk breast cancer after mastectomy: postmastectomy radiotherapy added to systemic therapy (CMF in premenopausal, tamoxifen in postmenopausal women) versus systemic therapy alone","sponsor":"Danish Breast Cancer Cooperative Group","result":"82b: 10-year locoregional recurrence 9% vs 32%; overall survival 54% vs 45%.","yearReported":1997,"enrolled":3083,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 10 years (82b)","primary":true,"unit":"%","arms":[{"name":"CMF plus postmastectomy radiotherapy","n":852,"value":54},{"name":"CMF alone","n":856,"value":45}]}]},{"id":"nct07705919","kind":"trial","name":"DCE-MRI for Neoadjuvant Treatment Assessment in Patients With Borderline Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of fluorouracil (5-FU), gemcitabine, fOLFIRI (5-FU, leucovorin, irinotecan), leucovorin (folinic acid) and other drugs in pancreatic cancer, run by Ohio State University Comprehensive Cancer Center, not yet recruiting.","summary":"DCE-MRI for Neoadjuvant Treatment Assessment in Patients With Borderline Resectable Pancreatic Cancer is a phase 1/2, interventional study registered as NCT07705919 by Ohio State University Comprehensive Cancer Center, with a registry enrolment figure of 50 participants, started 2026-09-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: Biospecimen Collection; Computed Tomography; Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Fluorouracil; Gadolinium-Chelate; Gemcitabine; Irinotecan; Leucovorin Calcium; Nab-paclitaxel; Oxaliplatin; Point-of-care portable perfusion phantom (P4). Conditions listed: Borderline Resectable Pancreatic Ductal Adenocarcinoma. Primary outcome: R0 resection rate. Pancreatic eligibility wording from the registry: \"* Histological or cytological evidence of pancreatic adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07705919","url":"https://clinicaltrials.gov/study/NCT07705919"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","gemcitabine","folfiri","leucovorin","nab-paclitaxel","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07705919","phase":"1/2","setting":"DCE-MRI-Informed Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer","sponsor":"Ohio State University Comprehensive Cancer Center","started":"2026-09-01","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"de-escalate","kind":"trial","name":"De-ESCALaTE HPV","aka":[],"tldr":"De-ESCALaTE, the European counterpart of RTOG 1016, found that cetuximab gave no less toxicity than cisplatin and worse tumour control in HPV-positive throat cancer.","summary":"De-ESCALaTE randomised 334 patients with low-risk HPV-positive oropharyngeal cancer to 70 Gy radiotherapy with cisplatin or with cetuximab. Severe toxicity, the primary endpoint, did not differ, while two-year overall survival was 97.5 percent with cisplatin and 89.4 percent with cetuximab and recurrence was more frequent with cetuximab (Mehanna and colleagues, Lancet 2019).","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01874171","url":"https://clinicaltrials.gov/study/NCT01874171"},{"label":"Lancet 2019","url":"https://doi.org/10.1016/S0140-6736(18)32752-1"}],"tags":["radiation-wave4"],"related":[],"cancers":["head-and-neck","oropharyngeal-cancer","hpv-positive-oropharyngeal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["cisplatin","cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":["chemoradiation","hpv-testing"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01874171","phase":"3","setting":"Low-risk HPV-positive oropharyngeal cancer: radiotherapy with cetuximab versus radiotherapy with cisplatin","sponsor":"University of Warwick","result":"Severe toxicity similar; 2-year overall survival 97.5% (cisplatin) vs 89.4% (cetuximab).","started":"2012-11-15","startedType":"actual","yearReported":2019,"enrolled":334,"enrolledBasis":"registry","outcomes":[{"endpoint":"Severe (grade 3-5) toxicity events per patient at 24 months","primary":true,"unit":"events per patient","arms":[{"name":"Radiotherapy + cisplatin","n":166,"value":4.8},{"name":"Radiotherapy + cetuximab","n":168,"value":4.8}],"p":"0.98","source":"https://doi.org/10.1016/S0140-6736(18)32752-1"},{"endpoint":"Overall survival at 2 years","unit":"%","arms":[{"name":"Radiotherapy + cisplatin","value":97.5},{"name":"Radiotherapy + cetuximab","value":89.4}],"hr":5,"ci":[1.7,14.7],"p":"0.001","source":"https://doi.org/10.1016/S0140-6736(18)32752-1"},{"endpoint":"Recurrence at 2 years","unit":"%","arms":[{"name":"Radiotherapy + cisplatin","value":6},{"name":"Radiotherapy + cetuximab","value":16.1}],"hr":3.4,"ci":[1.6,7.2],"p":"0.0007","source":"https://doi.org/10.1016/S0140-6736(18)32752-1"}]},{"id":"nct05255302","kind":"trial","name":"De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction","aka":["DIAL"],"tldr":"A phase 2/3 trial of pemetrexed in lung cancer, run by Intergroupe Francophone de Cancerologie Thoracique, now recruiting.","summary":"De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction is a phase 2/3, randomised interventional study registered as NCT05255302 by Intergroupe Francophone de Cancerologie Thoracique, with a registry enrolment figure of 1360 participants, started 2022-05-02 and due to reach its primary completion in 2025-05. Interventions recorded: Pembrolizumab before randomization; Chemotherapy; Pemetrexed; Pembrolizumab after randomization. Conditions listed: Metastatic NSCLC. Primary outcome: Phase II: 18-month overall survival (OS); Phase III: overall survival. Lung eligibility wording from the registry: \"Patients with histologically confirmed metastatic NSCLC (Stage IV accordingly to 8th classification TNM, UICC 2015)\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05255302","url":"https://clinicaltrials.gov/study/NCT05255302"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05255302","phase":"2/3","setting":"A Phase II-III Randomized Trial Evaluating Maintenance Pembrolizumab (± Pemetrexed) Until Progression Versus Observation (± Pemetrexed) After 6 Months of Platinum-based Doublet Chemotherapy Plus Pembrolizumab Induction Treatment in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Intergroupe Francophone de Cancerologie Thoracique","started":"2022-05-02","startedType":"actual","enrolled":1360,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06446557","kind":"trial","name":"De-scalation or swItch of Treatment According to Circulating tuMOr DNA Variation After 2 Cycles of Doublet Chemotherapy Plus Targeted Agent in Metastatic Unrese","aka":["DIAMOND"],"tldr":"A phase 3 trial in colorectal cancer, run by University Hospital, Rouen, not yet recruiting.","summary":"De-scalation or swItch of Treatment According to Circulating tuMOr DNA Variation After 2 Cycles of Doublet Chemotherapy Plus Targeted Agent in Metastatic Unresectable Colorectal Cancer is a phase 3, randomised interventional study registered as NCT06446557 by University Hospital, Rouen, with a registry enrolment figure of 408 participants, started 2026-06 and due to reach its primary completion in 2032-06-01. Interventions recorded: treatment adaptation guided by ctDNA variation; standard management. Conditions listed: Metastatic Colon Cancer. Primary outcome: Evaluate the superiority in quality-adjusted OS of an early treatment adaptation guided by ctDNA variation. Colorectal eligibility wording from the registry: \"* Histologically proven diagnosis of RAS WT or mutant, MSS, BRAFV600E non-mutated colorectal cancer\". Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06446557","url":"https://clinicaltrials.gov/study/NCT06446557"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06446557","phase":"3","setting":"De-scalation or swItch of Treatment According to Circulating tuMOr DNA Variation After 2 Cycles of Doublet Chemotherapy Plus Targeted Agent in Metastatic Unresectable Colorectal Cancer (DIAMOND Study): A Randomized Phase III of PRODIGE Intergroup","sponsor":"University Hospital, Rouen","started":"2026-06","startedType":"estimated","enrolled":408,"enrolledBasis":"registry","outcomes":[]},{"id":"debate","kind":"trial","name":"DEBATE","aka":[],"tldr":"DEBATE is a small Korean randomised trial of chemotherapy with or without the immunotherapy durvalumab before surgery for bile duct and gallbladder cancer, judged by how often the surgeon achieves a clear margin.","summary":"DEBATE (NCT04308174) randomised 45 patients with histologically confirmed, localised adenocarcinoma of the biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma, or gallbladder carcinoma) to preoperative gemcitabine and cisplatin with or without durvalumab, with postoperative durvalumab for the experimental arm. The primary endpoint is the R0 resection rate. Enrolment completed and the trial is active with primary completion recorded in June 2023 and study completion in December 2025; results were not found in Europe PMC in September 2026. It is one of the first randomised tests of perioperative chemo-immunotherapy in biliary cancer and includes gallbladder cancer.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04308174","url":"https://clinicaltrials.gov/study/NCT04308174"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","checkpoint-inhibitor"],"targets":[],"drugs":["gemcitabine-cisplatin","gemcitabine","cisplatin","durvalumab"],"companies":[],"institutions":["asan-medical-center"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04308174","phase":"2","setting":"Localised, resectable biliary tract cancer including gallbladder cancer: preoperative gemcitabine and cisplatin with or without durvalumab, followed by postoperative durvalumab in the durvalumab arm","sponsor":"Asan Medical Center","started":"2020-05-20","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06555003","kind":"trial","name":"DEBIRI Plus Chemotherapy vs. Chemotherapy Alone in Colorectal Cancer Liver Metastases","aka":["CLEAR-DEBIRI"],"tldr":"A phase 3 trial in colorectal cancer, run by Tehran University of Medical Sciences, now recruiting.","summary":"DEBIRI Plus Chemotherapy vs. Chemotherapy Alone in Colorectal Cancer Liver Metastases is a phase 3, randomised interventional study registered as NCT06555003 by Tehran University of Medical Sciences, with a registry enrolment figure of 116 participants, started 2025-01-20 and due to reach its primary completion in 2027-10. Interventions recorded: Drug-Eluting Embolic Bead; Chemotherapy drug. Conditions listed: Liver Neoplasm; Colorectal Cancer Metastatic. Primary outcome: Conversion to resectability: The proportion of patients who were initially deemed unresectable but, after undergoing specific intervention (Based on study arm) are reassessed for tumor shrinkage and found to be candidates for surgical resection.. Colorectal eligibility wording from the registry: \"* unresectable/borderline resectable colorectal cancer liver metastases, chemotherapy-naïve for metastatic disease, Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less adequate hematologic, hepatic, and renal function ( absolute neutrophil count ≥ 1\". Sites: Iran. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06555003","url":"https://clinicaltrials.gov/study/NCT06555003"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06555003","phase":"3","setting":"Comparative Analysis of the Efficacy of Irinotecan-loaded Drug-eluting Beads (DEBIRI) in Combination With Systemic Chemotherapy Versus Chemotherapy Alone in Unresectable Colorectal Cancer Liver Metastases: a Randomized Clinical Trial","sponsor":"Tehran University of Medical Sciences","started":"2025-01-20","startedType":"actual","enrolled":116,"enrolledBasis":"registry","outcomes":[]},{"id":"decision-sorafenib","kind":"trial","name":"DECISION","aka":[],"tldr":"The first drug approved for thyroid cancers that stopped responding to radioactive iodine.","summary":"DECISION, trial NCT00984282 sponsored by Bayer and reported in 2013, produced the first drug approved for differentiated thyroid cancers that stopped responding to radioactive iodine. It randomised 417 patients to sorafenib or placebo and met its primary progression-free survival endpoint, leading to FDA approval in November 2013, with hand-foot skin reaction and fatigue common. OnCo links it to thyroid cancer, kinase inhibitors, VEGF and BRAF as targets, the radioiodine-refractory term and Marcia S. Brose, and SELECT confirmed the class effect with a larger benefit for lenvatinib. Sorafenib has been largely displaced by lenvatinib but is still used, and whether it retains a niche in patients who cannot tolerate lenvatinib is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00984282","url":"https://clinicaltrials.gov/study/NCT00984282"},{"label":"Lancet 2014","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60421-9/fulltext"}],"tags":[],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["vegf","braf"],"drugs":[],"companies":["bayer"],"institutions":[],"pathways":[],"terms":["rai-refractory"],"trials":[],"people":["marcia-brose"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00984282","phase":"3","setting":"Radioiodine-refractory differentiated thyroid cancer: sorafenib vs placebo","sponsor":"Bayer","result":"PFS 10.8 vs 5.8 months; HR 0.59.","started":"2009-10-15","startedType":"actual","yearReported":2013,"enrolled":417,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Sorafenib","value":10.8},{"name":"Placebo","value":5.8}],"hr":0.59,"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60421-9/fulltext"}],"replication":"SELECT confirmed the class effect with a larger benefit."},{"id":"deep-c","kind":"trial","name":"DeeP-C","aka":[],"tldr":"The pivotal study for the first stool DNA test, showing it found more cancers than the standard stool blood test at the cost of more false positives.","summary":"In 9,989 evaluable participants (NEJM 2014), sensitivity for colorectal cancer was 92.3% for the multitarget stool DNA test versus 73.8% for FIT, sensitivity for advanced precancerous lesions 42.4% versus 23.8%, and specificity 86.6% versus 94.9% among participants with non-advanced or negative findings. The FDA approved Cologuard on the basis of these data in August 2014 and Medicare covered it the same day, the first parallel FDA-CMS review.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT01397747","url":"https://clinicaltrials.gov/study/NCT01397747"},{"label":"DeeP-C (NEJM 2014)","url":"https://doi.org/10.1056/NEJMoa1311194"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["colorectal-screening","methylation-profiling"],"targets":[],"drugs":["cologuard"],"companies":["exact-sciences"],"institutions":[],"pathways":[],"terms":["fit-test","sensitivity-specificity"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-imperiale-multitarget-stool-dna-screening-nejm-2014"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01397747","phase":"observational","setting":"Prospective cross-sectional study of multitarget stool DNA (Cologuard) and FIT against screening colonoscopy in average-risk adults aged 50 to 84","sponsor":"Exact Sciences","result":"Sensitivity 92.3% for colorectal cancer (FIT 73.8%); specificity 86.6% (FIT 94.9%).","started":"2011-06","yearReported":2014,"enrolled":9989,"enrolledBasis":"registry","outcomes":[{"endpoint":"Sensitivity for colorectal cancer","primary":true,"unit":"%","arms":[{"name":"Multitarget stool DNA (Cologuard)","value":92.3},{"name":"FIT","value":73.8}],"source":"https://doi.org/10.1056/NEJMoa1311194"}]},{"id":"defi","kind":"trial","name":"DeFi","aka":[],"tldr":"The first randomised trial to show a drug controls desmoid tumours, with better pain and function.","summary":"DeFi, trial NCT03785964 sponsored by SpringWorks and published in the New England Journal of Medicine in 2023, was the first randomised trial to show that a drug controls desmoid tumours, with better pain and physical function. It randomised 142 patients with progressing desmoid tumours to the gamma-secretase inhibitor nirogacestat or placebo, met its primary progression-free survival endpoint with a very large effect, produced responses in 41 percent against 8 percent including some complete responses, and led to approval in November 2023. OnCo links it to desmoid tumour and sarcomas, nirogacestat, the Wnt and beta-catenin pathway, the bottleneck of rare cancers without markets and the idea of intermittent or stop-and-restart dosing. Whether treatment can be paused once tumours are controlled is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03785964","url":"https://clinicaltrials.gov/study/NCT03785964"}],"tags":[],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":["gamma-secretase-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["nirogacestat"],"companies":["springworks"],"institutions":[],"pathways":["wnt"],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03785964","phase":"3","setting":"Progressing desmoid tumours: nirogacestat vs placebo","sponsor":"SpringWorks","result":"PFS HR 0.29; ORR 41% vs 8%.","started":"2019-04-17","startedType":"actual","yearReported":2022,"enrolled":142,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"arms":[{"name":"Nirogacestat","n":70},{"name":"Placebo","n":72}],"hr":0.29,"ci":[0.15,0.55],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2210140"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Nirogacestat","value":41},{"name":"Placebo","value":8}],"source":"https://doi.org/10.1056/NEJMoa2210140"}]},{"id":"nct05987644","kind":"trial","name":"Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements","aka":["DURABLE"],"tldr":"A phase 1/2 trial of alectinib in lung cancer, run by Joshua Palmer, now recruiting.","summary":"Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements is a phase 1/2, randomised interventional study registered as NCT05987644 by Joshua Palmer, with a registry enrolment figure of 56 participants, started 2024-03-07 and due to reach its primary completion in 2028-02-28. Interventions recorded: Alectinib; Stereotactic Radiosurgery. Conditions listed: Lung Cancer; NSCLC; Brain Metastases. Primary outcome: Phase 2: Neurological status and control of CNS disease at 12 months compared to alectinib plus SRS in patients with ≤15 CNS metastases; Phase 1b: Safety and Feasibility. Lung eligibility wording from the registry: \"Histological or cytological confirmation of Stage IV (per AJCC 8th edition) non-small cell lung cancer (NSCLC)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05987644","url":"https://clinicaltrials.gov/study/NCT05987644"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors","sbrt"],"targets":[],"drugs":["alectinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05987644","phase":"1/2","setting":"DURABLE: Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and rEarrangements","sponsor":"Joshua Palmer","started":"2024-03-07","startedType":"actual","enrolled":56,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06778382","kind":"trial","name":"Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Shandong Cancer Hospital and Institute, now recruiting.","summary":"Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer. is a phase 2, interventional study registered as NCT06778382 by Shandong Cancer Hospital and Institute, with a registry enrolment figure of 22 participants, started 2024-06-24 and due to reach its primary completion in 2025-11-01. Interventions recorded: Oligometastasis Treatment. Conditions listed: Colorectal Neoplasms Malignant. Primary outcome: Time Without Systemic Therapy. Colorectal eligibility wording from the registry: \"* Patients with a pathologically confirmed diagnosis of colorectal cancer with the following disease conditions:\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06778382","url":"https://clinicaltrials.gov/study/NCT06778382"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06778382","phase":"2","setting":"Deferred Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After NED in Colorectal Cancer： A Phase II, Single-Arm Clinical Trail.","sponsor":"Shandong Cancer Hospital and Institute","started":"2024-06-24","startedType":"actual","enrolled":22,"enrolledBasis":"registry","outcomes":[]},{"id":"dellphi-304","kind":"trial","name":"DeLLphi-304","aka":["dellphi-304"],"tldr":"DeLLphi-304 was the first trial in which a T-cell engager improved survival in a common solid tumour.","summary":"DeLLphi-304, trial NCT05740566 sponsored by Amgen and presented at the ASCO 2025 plenary and in the New England Journal of Medicine, was the first trial in which a T-cell engager improved survival in a common solid tumour, second-line small-cell lung cancer. It randomised 509 patients to the DLL3 engager tarlatamab or chemotherapy with topotecan, lurbinectedin or amrubicin, met its primary overall survival endpoint with a large effect, and improved progression-free survival and response rate. OnCo links it to small-cell lung cancer, DLL3 as a target, tarlatamab, topotecan, Luis Paz-Ares, Charles M. Rudin and the DeLLphi-301 paper, and it confirms the single-arm DeLLphi-301 result that supported accelerated approval. First-line data from DeLLphi-305 are pending, and whether tarlatamab belongs in maintenance rather than at relapse is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05740566","url":"https://clinicaltrials.gov/study/NCT05740566"}],"tags":[],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["t-cell-engager"],"targets":["dll3"],"drugs":["tarlatamab","amrubicin"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["luis-paz-ares","charles-rudin"],"bottlenecks":[],"keyPapers":["paper-dellphi-301-nejm-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05740566","phase":"3","setting":"Second-line small-cell lung cancer: tarlatamab vs chemotherapy","sponsor":"Amgen","result":"OS HR 0.60.","started":"2023-05-31","startedType":"actual","yearReported":2025,"enrolled":509,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Tarlatamab","n":254,"value":13.6},{"name":"Chemotherapy (topotecan, lurbinectedin, or amrubicin)","n":255,"value":8.3}],"hr":0.6,"ci":[0.47,0.77],"p":"<0.001","source":"https://clinicaltrials.gov/study/NCT05740566"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Tarlatamab","value":4.2},{"name":"Chemotherapy","value":3.7}],"hr":0.71,"ci":[0.59,0.86],"source":"https://clinicaltrials.gov/study/NCT05740566"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Tarlatamab","value":35},{"name":"Chemotherapy","value":20}],"source":"https://doi.org/10.1056/NEJMoa2502099"}],"replication":"Confirms the single-arm DeLLphi-301 result (ORR 40%) that supported accelerated approval; first-line data (DeLLphi-305) pending."},{"id":"dellphi-305","kind":"trial","name":"DeLLphi-305","aka":[],"tldr":"Tests whether adding the DLL3 T-cell engager to first-line maintenance can push median survival in extensive-stage disease past two years, as the phase 1b hinted.","summary":"Builds on DeLLphi-303 (phase 1b), where tarlatamab plus a PD-L1 inhibitor as first-line maintenance gave median OS 25.3 months and PFS 5.6 months. On 8 September 2026 Amgen and AstraZeneca announced that the trial met its primary overall survival endpoint at the pre-specified interim analysis, with statistically significant gains in progression-free survival and response rate; detailed figures are held for a congress presentation. A parallel phase 3 (DeLLphi-312) adds tarlatamab to induction chemo-immunotherapy.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06211036","url":"https://clinicaltrials.gov/study/NCT06211036"},{"label":"Amgen topline release (8 Sep 2026)","url":"https://www.amgen.com/newsroom/press-releases/2026/09/imdelltra-in-combination-with-imfinzi-demonstrated-landmark-improvement-in-overall-survival-in-first-line-extensive-stage-small-cell-lung-cancer"},{"label":"DeLLphi-303 results (IASLC)","url":"https://www.iaslc.org/iaslc-news/press-release/tarlatamab-anti-pd-l1-first-line-maintenance-after-chemo-immunotherapy-es"}],"tags":[],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["t-cell-engager"],"targets":["dll3"],"drugs":["tarlatamab","durvalumab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06211036","phase":"3","setting":"First-line maintenance in ES-SCLC after platinum-etoposide-durvalumab: tarlatamab + durvalumab vs durvalumab","sponsor":"Amgen","result":"Met the primary overall survival endpoint at the pre-specified interim analysis (Amgen, 8 September 2026); progression-free survival and response rate also improved; figures not yet disclosed.","started":"2024-06-05","startedType":"actual","yearReported":2026,"enrolled":563,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Tarlatamab + durvalumab maintenance","note":"Met at the pre-specified interim analysis: Amgen's 8 September 2026 release describes a statistically significant and clinically meaningful improvement; medians and hazard ratio not yet disclosed, detailed data promised for an upcoming congress"},{"name":"Durvalumab maintenance"}],"source":"https://www.amgen.com/newsroom/press-releases/2026/09/imdelltra-in-combination-with-imfinzi-demonstrated-landmark-improvement-in-overall-survival-in-first-line-extensive-stage-small-cell-lung-cancer"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Tarlatamab + durvalumab maintenance","note":"Statistically significant and clinically meaningful improvement per the sponsor; figures not yet public"},{"name":"Durvalumab maintenance"}],"source":"https://www.amgen.com/newsroom/press-releases/2026/09/imdelltra-in-combination-with-imfinzi-demonstrated-landmark-improvement-in-overall-survival-in-first-line-extensive-stage-small-cell-lung-cancer"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Tarlatamab + durvalumab maintenance","note":"Statistically significant improvement per the sponsor; figures not yet public"},{"name":"Durvalumab maintenance"}],"source":"https://www.amgen.com/newsroom/press-releases/2026/09/imdelltra-in-combination-with-imfinzi-demonstrated-landmark-improvement-in-overall-survival-in-first-line-extensive-stage-small-cell-lung-cancer"}],"replication":"First phase 3 of a DLL3 T-cell engager in first-line maintenance; consistent in direction with the DeLLphi-303 phase 1b cohort (median OS 25.3 months). DeLLphi-312 (tarlatamab added to induction chemo-immunotherapy) is the confirmatory sibling."},{"id":"nct00112463","kind":"trial","name":"Depsipeptide (Romidepsin) in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma","aka":[],"tldr":"A phase 2 trial of Romidepsin in Alveolar soft part sarcoma, Angiosarcoma, Epithelioid sarcoma, Chondrosarcoma, Osteosarcoma and Leiomyosarcoma, run by National Cancer Institute (NCI), completed.","summary":"Depsipeptide (Romidepsin) in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma is a phase 2 interventional study registered as NCT00112463 by National Cancer Institute (NCI), with 40 participants recorded, started 2005-01-07 and reaching its primary completion in 2008-10-23. Interventions recorded: romidepsin. Conditions recorded: Adult Alveolar Soft-part Sarcoma, Adult Angiosarcoma, Adult Epithelioid Sarcoma, Adult Extraskeletal Chondrosarcoma, Adult Extraskeletal Osteosarcoma, Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Liposarcoma, Adult Malignant Fibrous Histiocytoma, Adult Malignant Hemangiopericytoma, Adult Malignant Mesenchymoma, Adult Neurofibrosarcoma, Adult Rhabdomyosarcoma, Adult Synovial Sarcoma, Gastrointestinal Stromal Tumor, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Adult Soft Tissue Sarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma.\n\nLinked to the drug Romidepsin because the registry names it among its interventions and Alveolar soft part sarcoma, Angiosarcoma, Epithelioid sarcoma, Chondrosarcoma, Osteosarcoma and Leiomyosarcoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00112463","url":"https://clinicaltrials.gov/study/NCT00112463"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["alveolar-soft-part-sarcoma","angiosarcoma","epithelioid-sarcoma","chondrosarcoma","osteosarcoma","leiomyosarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["romidepsin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00112463","phase":"2","setting":"A Phase II Study of Single Agent Depsipeptide (FK228) in Metastatic or Unresectable Soft Tissue Sarcomas","sponsor":"National Cancer Institute (NCI)","started":"2005-01-07","startedType":"actual","yearReported":2017,"enrolled":40,"enrolledBasis":"registry","outcomes":[{"endpoint":"Time to Progression","primary":true,"unit":"months","arms":[{"name":"Treatment (Single-agent Depsipeptide)","n":38,"value":1.9,"note":"95% CI 1.7 to 2.5; Figures from the ClinicalTrials.gov results section (first posted 2017-05-12), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00112463?tab=results"}]},{"id":"desktop-iii","kind":"trial","name":"DESKTOP III / ENGOT-ov20","aka":[],"tldr":"Operating again at first relapse, in carefully selected women, added about seven months of life.","summary":"DESKTOP III, also ENGOT-ov20, trial NCT01166737 sponsored by the AGO group and published in the New England Journal of Medicine in 2021, showed that operating again at first platinum-sensitive relapse of ovarian cancer, in women carefully selected by a positive AGO score, adds about seven months of life. It randomised 407 patients to secondary cytoreductive surgery plus chemotherapy or chemotherapy alone, met its primary overall survival endpoint, and the benefit was concentrated in patients whose tumour was completely resected. OnCo links it to ovarian cancer, minimally invasive surgery and Andreas du Bois; it contradicted the negative surgery arm of GOG-0213, with patient selection the likely explanation, while the Chinese SOC-1 trial showed a progression benefit. Whether the AGO score can be reproduced outside expert centres is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01166737","url":"https://clinicaltrials.gov/study/NCT01166737"},{"label":"NEJM 2021","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2103294"}],"tags":[],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["robotic-surgery"],"targets":[],"drugs":[],"companies":["ago-study-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["andreas-du-bois"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01166737","phase":"3","setting":"First platinum-sensitive relapse with a positive AGO score: secondary cytoreductive surgery + chemotherapy vs chemotherapy alone","sponsor":"AGO","result":"OS 53.7 vs 46.0 months (HR 0.75).","started":"2010-07","startedType":"actual","yearReported":2020,"enrolled":408,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Surgery + chemotherapy","n":206,"value":53.7},{"name":"Chemotherapy alone","n":201,"value":46}],"hr":0.75,"ci":[0.59,0.96],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2103294"}],"replication":"GOG-0213 found no benefit without selection criteria; SOC-1 (China) showed a PFS benefit."},{"id":"destiny-breast03","kind":"trial","name":"DESTINY-Breast03","aka":[],"tldr":"The head-to-head ADC trial where Enhertu beat Kadcyla by a wide margin, showing that payload and bystander effect matter.","summary":"DESTINY-Breast03, trial NCT03529110 sponsored by Daiichi Sankyo and AstraZeneca and reported in 2021, was the head-to-head antibody-drug conjugate trial in which trastuzumab deruxtecan beat trastuzumab emtansine by a wide margin in HER2-positive metastatic breast cancer after trastuzumab and a taxane, showing that payload and bystander effect matter. It randomised 524 patients, met its primary progression-free survival endpoint by blinded review with a very large effect and a much higher response rate, and showed an overall survival benefit, redefining second-line HER2-positive therapy and validating the DXd platform. OnCo links it to HER2-positive breast cancer, both drugs, Ian E. Krop, Javier Cortés, Sara A. Hurvitz, Sung-Bae Kim, Vall d'Hebron, the ADC roadmap and the DESTINY-Breast03 and KATHERINE papers. Whether T-DM1 retains any role after this result is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT03529110","url":"https://clinicaltrials.gov/study/NCT03529110"}],"tags":[],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan","trastuzumab-emtansine"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ian-krop","javier-cortes","sara-hurvitz","kim-sung-bae"],"bottlenecks":[],"keyPapers":["paper-destiny-breast03-nejm-2022","paper-destiny-breast03-lancet-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03529110","phase":"3","setting":"HER2+ metastatic breast cancer after trastuzumab and taxane: T-DXd vs T-DM1","sponsor":"Daiichi Sankyo / AstraZeneca","result":"PFS HR 0.33; OS HR 0.64.","started":"2018-08-09","startedType":"actual","yearReported":2021,"enrolled":524,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Trastuzumab deruxtecan","n":261,"value":28.8},{"name":"Trastuzumab emtansine","n":263,"value":6.8}],"hr":0.33,"ci":[0.26,0.43],"p":"<0.0001","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02420-5/fulltext"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Trastuzumab deruxtecan","value":52.6},{"name":"Trastuzumab emtansine","value":42.7}],"hr":0.73,"ci":[0.56,0.94],"source":"https://clinicaltrials.gov/study/NCT03529110"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Trastuzumab deruxtecan","value":78.5},{"name":"Trastuzumab emtansine","value":35}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2115022"}],"replication":"Head-to-head ADC trial; consistent with the single-arm DESTINY-Breast01 (ORR 61%) and with DESTINY-Breast02 versus treatment of physician's choice."},{"id":"destiny-breast04","kind":"trial","name":"DESTINY-Breast04","aka":[],"tldr":"Created a new category of breast cancer, HER2-low, by showing Enhertu works in tumours previously called HER2-negative.","summary":"DESTINY-Breast04, trial NCT03734029 sponsored by Daiichi Sankyo and AstraZeneca and published in the New England Journal of Medicine in 2022, created a new category of breast cancer, HER2-low, by showing that trastuzumab deruxtecan works in tumours previously called HER2-negative after chemotherapy. It randomised 557 patients to trastuzumab deruxtecan or chemotherapy, met its primary progression-free survival endpoint in the HR-positive cohort and showed an overall survival benefit in all patients, with an exploratory HR-negative cohort pointing the same way, and it drew a standing ovation at ASCO 2022 as roughly half of all breast cancers became eligible for a HER2-directed drug. Whether pathologists can score HER2-low reproducibly is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT03734029","url":"https://clinicaltrials.gov/study/NCT03734029"},{"label":"DESTINY-Breast04 long-term survival (Nature Medicine 2025)","url":"https://doi.org/10.1038/s41591-025-03981-4"},{"label":"NICE TA992 (29 July 2024): not recommended","url":"https://www.nice.org.uk/guidance/ta992"}],"tags":[],"related":[],"cancers":["breast-hr-positive","tnbc","her2-low-metastatic-breast-cancer","tnbc-metastatic"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":["her2-low"],"trials":[],"people":["shanu-modi"],"bottlenecks":[],"keyPapers":["paper-schettini-her2-low-features-npj-breast-cancer-2021","paper-destiny-breast04-nejm-2022","paper-destiny-breast04-nat-med-2025-update"],"journals":[],"dependsOn":[],"notes":["Triple-negative cohort: 63 of 557 patients (11.3 percent) were hormone-receptor-negative; median progression-free survival in that exploratory cohort 8.5 versus 2.9 months (hazard ratio 0.46) and overall survival favoured trastuzumab deruxtecan at the 32-month follow-up (Nature Medicine 2025: overall cohort 22.9 versus 16.8 months, hazard ratio 0.69). Interstitial lung disease 12.1 percent, 0.8 percent fatal. UK sites (registry, 7): Royal Cornwall Truro, Queen Mary University of London, University College London Hospitals, Royal Free, Western General Edinburgh, Nottingham City, Royal Surrey Guildford. England: NICE TA992 (29 July 2024) does not recommend the drug for HER2-low disease; rapid review GID-TA12551 in development."],"nct":"NCT03734029","phase":"3","setting":"HER2-low metastatic breast cancer after chemotherapy: T-DXd vs chemotherapy","sponsor":"Daiichi Sankyo / AstraZeneca","result":"OS HR 0.64.","started":"2018-12-27","startedType":"actual","yearReported":2022,"enrolled":557,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival, HR+ cohort (BICR)","primary":true,"unit":"months","arms":[{"name":"Trastuzumab deruxtecan","n":331,"value":10.1},{"name":"Chemotherapy (TPC)","n":163,"value":5.4}],"hr":0.51,"ci":[0.4,0.64],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2203690"},{"endpoint":"Overall survival, all patients","unit":"months","arms":[{"name":"Trastuzumab deruxtecan","n":373,"value":23.4},{"name":"Chemotherapy (TPC)","n":184,"value":16.8}],"hr":0.64,"ci":[0.49,0.84],"p":"0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2203690"},{"endpoint":"Progression-free survival, HR-negative (TNBC) cohort","unit":"months","arms":[{"name":"Trastuzumab deruxtecan","n":40,"value":8.5,"note":"Exploratory cohort"},{"name":"Chemotherapy (TPC)","n":18,"value":2.9}],"hr":0.46,"ci":[0.24,0.89],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2203690"}],"replication":"Confirmed and extended by DESTINY-Breast06 (HER2-low and ultralow, chemotherapy-naive) with a near-identical PFS hazard ratio."},{"id":"destiny-breast05","kind":"trial","name":"DESTINY-Breast05","aka":[],"tldr":"Enhertu cut recurrence or death by more than half compared with Kadcyla in women with cancer left after pre-surgery treatment, replacing the KATHERINE standard.","summary":"DESTINY-Breast05, trial NCT04622319 sponsored by Daiichi Sankyo and AstraZeneca and reported at ESMO 2025, showed that trastuzumab deruxtecan cut recurrence or death by more than half compared with trastuzumab emtansine in women with high-risk HER2-positive early breast cancer left with residual disease after pre-surgery treatment, replacing the KATHERINE standard. It randomised 1,635 women and met its primary invasive disease-free survival endpoint at an interim analysis with a large effect, at the cost of more interstitial lung disease, and the FDA approved the post-neoadjuvant indication in the second quarter of 2026 alongside the neoadjuvant DESTINY-Breast11 indication. OnCo links it to trastuzumab deruxtecan and trastuzumab emtansine, to trastuzumab brengitecan as a follower. Whether the lung toxicity is acceptable in a curative setting is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04622319","url":"https://clinicaltrials.gov/study/NCT04622319"},{"label":"NEJM","url":"https://pubmed.ncbi.nlm.nih.gov/41370739/"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan","trastuzumab-emtansine"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-destiny-breast05-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04622319","phase":"3","setting":"High-risk HER2+ early breast cancer with residual invasive disease after neoadjuvant therapy: T-DXd vs T-DM1","sponsor":"Daiichi Sankyo / AstraZeneca","result":"3-year iDFS 92.4% vs 83.7%, HR 0.47.","started":"2020-12-04","startedType":"actual","yearReported":2025,"enrolled":1635,"enrolledBasis":"registry","outcomes":[{"endpoint":"3-year invasive disease-free survival","primary":true,"unit":"%","arms":[{"name":"T-DXd","value":92.4},{"name":"T-DM1","value":83.7}],"hr":0.47,"ci":[0.34,0.66],"p":"<0.0001","source":"https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-reduced-the-risk-of-disease-recurrence-or-death-by-53-vs-t-dm1-in-patients-with-high-risk-her2-positive-early-breast-cancer.html"}],"replication":"Consistent with DESTINY-Breast03 (T-DXd vs T-DM1 in metastatic disease, PFS HR 0.33)."},{"id":"destiny-breast06","kind":"trial","name":"DESTINY-Breast06","aka":[],"tldr":"Moved Enhertu ahead of chemotherapy in hormone-positive breast cancer and extended it to 'ultralow' HER2.","summary":"DESTINY-Breast06, trial NCT04494425 sponsored by Daiichi Sankyo and AstraZeneca and published in the New England Journal of Medicine in 2024, moved trastuzumab deruxtecan ahead of chemotherapy in HR-positive, HER2-low breast cancer after endocrine therapy and extended it to HER2-ultralow tumours. It randomised 866 chemotherapy-naive patients to trastuzumab deruxtecan or chemotherapy, met its primary progression-free survival endpoint in HER2-low disease with a similar benefit in the ultralow group and a much higher response rate, and was approved in 2025. It replicates DESTINY-Breast04 in an earlier line, and whether any HER2 expression threshold matters at all is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT04494425","url":"https://clinicaltrials.gov/study/NCT04494425"}],"tags":[],"related":[],"cancers":["breast-hr-positive","her2-low-metastatic-breast-cancer","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":["her2-low"],"trials":[],"people":["giuseppe-curigliano"],"bottlenecks":[],"keyPapers":["paper-destiny-breast06-nejm-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04494425","phase":"3","setting":"HR+ HER2-low/ultralow breast cancer after endocrine therapy, chemotherapy-naive: T-DXd vs chemotherapy","sponsor":"Daiichi Sankyo / AstraZeneca","result":"PFS HR 0.62.","started":"2020-07-24","startedType":"actual","yearReported":2024,"enrolled":866,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival, HER2-low (BICR)","primary":true,"unit":"months","arms":[{"name":"Trastuzumab deruxtecan","n":359,"value":13.2},{"name":"Chemotherapy (TPC)","n":354,"value":8.1}],"hr":0.62,"ci":[0.51,0.74],"p":"<0.0001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2407086"},{"endpoint":"Progression-free survival, ITT (HER2-low + ultralow)","unit":"months","arms":[{"name":"Trastuzumab deruxtecan","n":436,"value":13.2},{"name":"Chemotherapy (TPC)","n":430,"value":8.1}],"hr":0.63,"ci":[0.53,0.75],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2407086"},{"endpoint":"Objective response rate, HER2-low","unit":"%","arms":[{"name":"Trastuzumab deruxtecan","value":56.5},{"name":"Chemotherapy (TPC)","value":32.2}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2407086"}],"replication":"Replicates DESTINY-Breast04 in an earlier line and extends it to HER2-ultralow."},{"id":"destiny-breast09","kind":"trial","name":"DESTINY-Breast09","aka":[],"tldr":"Showed Enhertu plus pertuzumab beats the decade-old first-line standard for HER2-positive metastatic breast cancer.","summary":"DESTINY-Breast09, trial NCT04784715 sponsored by Daiichi Sankyo and AstraZeneca and reported in 2025, showed that trastuzumab deruxtecan plus pertuzumab beats the decade-old first-line standard of a taxane, trastuzumab and pertuzumab for HER2-positive metastatic breast cancer. It randomised 1,157 patients across three arms, met its primary progression-free survival endpoint by blinded review for the combination against THP with a large effect and a higher response rate, with overall survival immature but trending favourably, while the trastuzumab deruxtecan monotherapy arm remained blinded. OnCo links it to HER2-positive breast cancer, trastuzumab deruxtecan, pertuzumab, Cristina Saura, Javier Cortés, Sara M. Tolaney and Vall d'Hebron. It replaces the CLEOPATRA-era regimen, and whether the ADC alone would do as well as the combination is the question the blinded arm will answer.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT04784715","url":"https://clinicaltrials.gov/study/NCT04784715"}],"tags":[],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["cristina-saura","javier-cortes","sara-tolaney"],"bottlenecks":[],"keyPapers":["paper-destiny-breast09-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04784715","phase":"3","setting":"First-line HER2+ metastatic breast cancer: T-DXd + pertuzumab vs THP","sponsor":"Daiichi Sankyo / AstraZeneca","result":"PFS HR 0.56.","started":"2021-04-26","startedType":"actual","yearReported":2025,"enrolled":1157,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR), T-DXd + pertuzumab vs THP","primary":true,"unit":"months","arms":[{"name":"Trastuzumab deruxtecan + pertuzumab","n":383,"value":40.7},{"name":"Taxane + trastuzumab + pertuzumab","n":387,"value":26.9}],"hr":0.56,"ci":[0.44,0.71],"p":"<0.00001","source":"https://ascopubs.org/doi/10.1200/JCO.2025.43.17_suppl.LBA1008"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Trastuzumab deruxtecan + pertuzumab","value":85.1},{"name":"Taxane + trastuzumab + pertuzumab","value":78.6}],"source":"https://doi.org/10.1056/NEJMoa2508668"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Trastuzumab deruxtecan + pertuzumab","note":"Immature at the interim analysis; early trend favoured T-DXd + pertuzumab."},{"name":"Taxane + trastuzumab + pertuzumab"}],"source":"https://doi.org/10.1056/NEJMoa2508668"}],"replication":"Single pivotal trial versus the CLEOPATRA-era standard; the T-DXd monotherapy arm is still blinded. Consistent with the class's performance in DESTINY-Breast03."},{"id":"destiny-breast11","kind":"trial","name":"DESTINY-Breast11","aka":[],"tldr":"DESTINY-Breast11 brought Enhertu into pre-surgery treatment of HER2-positive breast cancer, replacing anthracyclines.","summary":"DESTINY-Breast11, trial NCT05113251 sponsored by Daiichi Sankyo and AstraZeneca and reported in 2025, brought trastuzumab deruxtecan into pre-surgery treatment of high-risk HER2-positive early breast cancer, replacing anthracyclines. It randomised 927 patients to trastuzumab deruxtecan followed by a taxane, trastuzumab and pertuzumab, or dose-dense anthracycline chemotherapy followed by the same, met its primary pathologic complete response endpoint with a better tolerated regimen, and led to FDA approval in the second quarter of 2026 alongside DESTINY-Breast05, while the trastuzumab deruxtecan monotherapy arm was stopped early for lower efficacy and event-free survival remains immature. Whether a higher pathologic complete response rate converts into fewer recurrences is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05113251","url":"https://clinicaltrials.gov/study/NCT05113251"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":["pcr"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05113251","phase":"3","setting":"Neoadjuvant high-risk HER2+ early breast cancer: T-DXd followed by THP vs ddAC-THP","sponsor":"Daiichi Sankyo / AstraZeneca","result":"pCR 67.3% vs 56.3%.","started":"2021-10-25","startedType":"actual","yearReported":2025,"enrolled":927,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathologic complete response (ypT0/Tis ypN0)","primary":true,"unit":"%","arms":[{"name":"T-DXd → THP","n":321,"value":67.3},{"name":"ddAC → THP","n":320,"value":56.3}],"p":"0.003","source":"https://web.archive.org/web/20231201043719/https://www.esmo.org/newsroom/press-releases"},{"endpoint":"Event-free survival","unit":"months","arms":[{"name":"T-DXd → THP","note":"Immature; the T-DXd monotherapy arm was stopped early for lower efficacy."},{"name":"ddAC → THP"}]}],"replication":"Single pivotal neoadjuvant trial; pCR is a surrogate. The post-neoadjuvant DESTINY-Breast05 (T-DXd vs T-DM1) is the companion evidence in early HER2+ disease."},{"id":"destiny-breast12","kind":"trial","name":"DESTINY-Breast12","aka":[],"tldr":"Enhertu shrank brain metastases in most patients, including those with untreated lesions, answering a question its earlier trials had excluded.","summary":"DESTINY-Breast12, trial NCT04739761 sponsored by AstraZeneca and Daiichi Sankyo and reported in 2024, was a phase 3b/4 single-arm study showing that trastuzumab deruxtecan shrinks brain metastases in most patients with HER2-positive metastatic breast cancer, including those with untreated lesions, answering a question its earlier trials had excluded. Among 504 patients, 263 with brain metastases, the intracranial objective response rate was high, higher still in active or untreated brain metastases, and most patients with brain disease were progression-free at twelve months. OnCo links it to trastuzumab deruxtecan, the HER2-positive brain metastases term, the idea of systemic-first management of brain metastases and the brain as a bottleneck. Without a randomised comparison, whether systemic therapy should replace radiotherapy first in selected patients remains open.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04739761","url":"https://clinicaltrials.gov/study/NCT04739761"}],"tags":[],"related":[],"cancers":["breast-her2-positive","secondary-brain-tumours","her2-positive-breast-brain-metastases"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":["her2-brain-metastases"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-destiny-breast12-nat-med-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04739761","phase":"3","setting":"HER2+ metastatic breast cancer with or without brain metastases: single-arm T-DXd","sponsor":"AstraZeneca / Daiichi Sankyo","result":"CNS ORR 71.7%; 12-month PFS 61.6% in brain-metastasis cohort.","started":"2021-06-22","startedType":"actual","yearReported":2024,"enrolled":506,"enrolledBasis":"registry","outcomes":[{"endpoint":"Intracranial objective response rate","primary":true,"unit":"%","arms":[{"name":"T-DXd (brain metastasis cohort)","n":263,"value":71.7}],"source":"https://www.nature.com/articles/s41591-024-03261-7"}],"replication":"Consistent with DEBBRAH and TUXEDO phase 2 studies of T-DXd in brain metastases."},{"id":"destiny-crc01","kind":"trial","name":"DESTINY-CRC01","aka":[],"tldr":"The first trial of the HER2 antibody-drug conjugate in bowel cancer. Almost half the strongly HER2-positive tumours shrank, including some that had already failed other HER2 drugs.","summary":"DESTINY-CRC01 enrolled 78 treated patients into three cohorts by HER2 expression: cohort A (IHC 3+ or IHC 2+ and ISH-positive, 53 patients), cohort B (IHC 2+, ISH-negative, seven) and cohort C (IHC 1+, 18). In cohort A the confirmed objective response rate was 45.3 percent (95% CI 31.6 to 59.6) after a median 27.1 weeks. Grade 3 or worse events in at least a tenth of participants were decreased neutrophil count (22 percent) and anaemia (14 percent); five patients (6 percent) had adjudicated interstitial lung disease or pneumonitis, two of them fatal, the only treatment-related deaths. DESTINY-CRC02 then tested the lower 5.4 mg/kg dose (response 37.8 percent) which is the dose in the April 2024 tumour-agnostic HER2 IHC 3+ accelerated approval.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03384940","url":"https://clinicaltrials.gov/study/NCT03384940"},{"label":"DESTINY-CRC01: trastuzumab deruxtecan in HER2-expressing metastatic colorectal cancer (Lancet Oncology 2021)","url":"https://doi.org/10.1016/S1470-2045(21)00086-3"}],"tags":[],"related":[],"cancers":["colorectal","her2-amplified-colorectal"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["her2"],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":["tumour-agnostic"],"trials":["destiny-crc02","mountaineer"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03384940","phase":"2","setting":"HER2-expressing metastatic colorectal cancer, RAS and BRAF V600E wild-type, after two or more previous regimens: trastuzumab deruxtecan 6.4 mg/kg, in three cohorts by HER2 level","sponsor":"Daiichi Sankyo","result":"Confirmed objective response 45.3 percent in HER2-positive disease; interstitial lung disease in 6 percent, two deaths.","started":"2018-02-23","startedType":"actual","yearReported":2021,"enrolled":86,"enrolledBasis":"treated","enrolledNote":"The registry lists 86 enrolled; 78 patients received at least one dose and are the reported population.","outcomes":[{"endpoint":"Confirmed objective response rate (cohort A, HER2-positive)","primary":true,"unit":"percent","arms":[{"name":"Trastuzumab deruxtecan 6.4 mg/kg","n":53,"value":45.3}],"ci":[31.6,59.6],"source":"https://doi.org/10.1016/S1470-2045(21)00086-3"}],"replication":"DESTINY-CRC02 confirmed activity at 5.4 mg/kg (ORR 37.8 percent) with a better safety profile."},{"id":"destiny-crc02","kind":"trial","name":"DESTINY-CRC02","aka":[],"tldr":"Enhertu shrank about four in ten heavily pretreated HER2-positive bowel cancers, including ones that had already stopped responding to other HER2 drugs.","summary":"DESTINY-CRC02, trial NCT04744831 sponsored by Daiichi Sankyo and AstraZeneca and reported in 2023, showed that trastuzumab deruxtecan shrinks about four in ten heavily pretreated HER2-positive metastatic colorectal cancers, including ones that had already stopped responding to other HER2 drugs. It randomised 122 patients to 5.4 or 6.4 mg/kg, with confirmed response rates of 37.8 and 27.5 percent respectively, responses regardless of prior HER2 therapy or RAS status, and the data supported the 2024 tumour-agnostic HER2 IHC 3+ accelerated approval, which covers colorectal cancer at the lower dose. OnCo links it to colorectal cancer, HER2 as a target, trastuzumab deruxtecan and the tumour-agnostic approval term, and the result is consistent with DESTINY-CRC01. Without a randomised comparison, whether the drug improves survival over other HER2 combinations is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04744831","url":"https://clinicaltrials.gov/study/NCT04744831"}],"tags":[],"related":[],"cancers":["colorectal","her2-amplified-colorectal"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["her2"],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":["tumour-agnostic"],"trials":["destiny-crc01","mountaineer-03"],"people":[],"bottlenecks":[],"keyPapers":["paper-valtorta-her2-scoring-colorectal-heracles-mod-pathol-2015","paper-destiny-crc02-lancet-oncol-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04744831","phase":"2","setting":"Pretreated HER2-positive metastatic colorectal cancer: T-DXd 5.4 vs 6.4 mg/kg","sponsor":"Daiichi Sankyo / AstraZeneca","result":"ORR 37.8% (5.4 mg/kg).","started":"2021-03-05","startedType":"actual","yearReported":2023,"enrolled":122,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"percent","arms":[{"name":"T-DXd 5.4 mg/kg","n":82,"value":37.8},{"name":"T-DXd 6.4 mg/kg","n":40,"value":27.5}],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00380-2/abstract"}],"replication":"Consistent with DESTINY-CRC01 (ORR 45% in IHC3+/ISH+)."},{"id":"nct06989112","kind":"trial","name":"DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC","aka":["DESTINY-Endometrial01"],"tldr":"A phase 3 trial of Trastuzumab deruxtecan, Rilvegostomig, Pembrolizumab in endometrial cancer, run by AstraZeneca, now recruiting.","summary":"DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer is a phase 3 interventional study registered as NCT06989112 by AstraZeneca, with 600 participants planned, started 2025-03-27 and due to reach its primary completion in 2029-01-19. Interventions recorded: Trastuzumab deruxtecan, Rilvegostomig, Pembrolizumab, Carboplatin, Paclitaxel. Conditions listed: Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06989112","url":"https://clinicaltrials.gov/study/NCT06989112"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan","rilvegostomig","pembrolizumab","carboplatin","paclitaxel","docetaxel"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06989112","phase":"3","setting":"DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer","sponsor":"AstraZeneca","started":"2025-03-27","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"destiny-gastric01","kind":"trial","name":"DESTINY-Gastric01","aka":[],"tldr":"DESTINY-Gastric01 showed that trastuzumab deruxtecan shrank tumours far more often than standard chemotherapy, and helped people live longer, in HER2-positive stomach cancer that had already progressed on trastuzumab.","summary":"DESTINY-Gastric01 was an open-label randomised phase 2 trial in Japan and South Korea. Patients with HER2-positive gastric or gastro-oesophageal junction adenocarcinoma whose disease had progressed after at least two regimens including trastuzumab were randomised two to one to trastuzumab deruxtecan or to the physician's choice of irinotecan or paclitaxel. The primary endpoint was objective response by independent review. Exploratory cohorts enrolled HER2-low tumours.\n\nThe response rate was substantially higher with trastuzumab deruxtecan and overall survival was longer than with chemotherapy. Interstitial lung disease and myelosuppression were the notable toxicities. The result led to approval in the United States in January 2021 for HER2-positive gastric cancer after a trastuzumab-based regimen, the first antibody-drug conjugate for the disease.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03329690","url":"https://clinicaltrials.gov/study/NCT03329690"}],"tags":["subtype-trials"],"related":[],"cancers":["gastric-her2-positive","gastric"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan","irinotecan","paclitaxel"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["shitara-kohei"],"bottlenecks":[],"keyPapers":["paper-destiny-gastric01-nejm-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03329690","phase":"2","setting":"HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after at least two prior regimens including trastuzumab: trastuzumab deruxtecan against physician's choice of irinotecan or paclitaxel","sponsor":"Daiichi Sankyo","result":"Higher objective response rate and longer overall survival with trastuzumab deruxtecan than with irinotecan or paclitaxel; approved in January 2021.","started":"2017-11-02","startedType":"actual","yearReported":2020,"enrolled":233,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response (independent central review)","primary":true,"unit":"%","arms":[{"name":"Trastuzumab deruxtecan","n":125,"value":51},{"name":"Physician's choice chemotherapy (irinotecan or paclitaxel)","n":62,"value":14}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa2004413"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Trastuzumab deruxtecan","n":125,"value":12.5},{"name":"Physician's choice chemotherapy (irinotecan or paclitaxel)","n":62,"value":8.4}],"hr":0.59,"ci":[0.39,0.88],"p":"0.01","source":"https://doi.org/10.1056/NEJMoa2004413"}]},{"id":"destiny-gastric02","kind":"trial","name":"DESTINY-Gastric02","aka":[],"tldr":"DESTINY-Gastric02 repeated the trastuzumab deruxtecan study in patients from Europe and the United States, after the first trial had been run only in Japan and Korea, and confirmed that the drug produces meaningful responses in HER2-positive stomach cancer after trastuzumab.","summary":"DESTINY-Gastric01 enrolled only East Asian patients, where stomach cancer is treated differently and diagnosed earlier. DESTINY-Gastric02 was a single-arm phase 2 study in the United States and Europe of trastuzumab deruxtecan in 79 patients with HER2-positive gastric or gastro-oesophageal junction cancer that had progressed on a first-line trastuzumab regimen, with the HER2 status re-confirmed on a fresh biopsy. The primary endpoint was confirmed objective response by independent review.\n\nThe study confirmed clinically meaningful and durable responses in a Western population, with a safety profile consistent with the earlier trial, supporting the drug's use outside East Asia. The subtype page notes that the response rate was lower than in the Asian trial.","status":"completed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04014075","url":"https://clinicaltrials.gov/study/NCT04014075"}],"tags":["subtype-trials"],"related":[],"cancers":["gastric-her2-positive","gastric"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["eric-van-cutsem"],"bottlenecks":[],"keyPapers":["paper-destiny-gastric01-nejm-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04014075","phase":"2","setting":"Western patients with HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after a trastuzumab-containing regimen: single-arm trastuzumab deruxtecan","sponsor":"Daiichi Sankyo","result":"Confirmed durable responses to trastuzumab deruxtecan in a Western population after progression on trastuzumab.","started":"2019-11-26","startedType":"actual","yearReported":2023,"enrolled":79,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed objective response by independent central review (registry results, primary analysis)","primary":true,"unit":"%","arms":[{"name":"Trastuzumab deruxtecan","n":79,"value":38,"note":"95% CI 27.3 to 49.6"}],"source":"https://clinicaltrials.gov/study/NCT04014075?tab=results"},{"endpoint":"Confirmed objective response by independent central review (registry results, later analysis)","unit":"%","arms":[{"name":"Trastuzumab deruxtecan","n":79,"value":41.8,"note":"95% CI 30.8 to 53.4"}],"source":"https://clinicaltrials.gov/study/NCT04014075?tab=results"}]},{"id":"destiny-gastric04","kind":"trial","name":"DESTINY-Gastric04","aka":[],"tldr":"The first randomised proof that a HER2 drug beats standard chemotherapy in second-line stomach cancer: Enhertu added about three months of life.","summary":"DESTINY-Gastric04, trial NCT04704934 sponsored by Daiichi Sankyo and AstraZeneca and reported at the ASCO 2025 plenary and in the New England Journal of Medicine, was the first randomised proof that a HER2 drug beats standard chemotherapy in second-line HER2-positive gastric cancer, with trastuzumab deruxtecan adding a few months of life. It randomised 494 patients after trastuzumab to trastuzumab deruxtecan or ramucirumab plus paclitaxel and met its primary overall survival endpoint, also improving progression-free survival, confirming the accelerated approvals from DESTINY-Gastric01 and DESTINY-Gastric02; interstitial lung disease requires monitoring. Where it sits after zanidatamab-based first-line therapy is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04704934","url":"https://clinicaltrials.gov/study/NCT04704934"}],"tags":[],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["her2"],"drugs":["trastuzumab-deruxtecan","ramucirumab"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":["ild"],"trials":[],"people":["shitara-kohei"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04704934","phase":"3","setting":"Second-line HER2-positive gastric/GEJ cancer after trastuzumab: T-DXd vs ramucirumab + paclitaxel","sponsor":"Daiichi Sankyo / AstraZeneca","result":"OS 14.7 vs 11.4 months, HR 0.70.","started":"2021-05-21","startedType":"actual","yearReported":2025,"enrolled":494,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"T-DXd 6.4 mg/kg","n":246,"value":14.7},{"name":"Ramucirumab + paclitaxel","n":248,"value":11.4}],"hr":0.7,"source":"https://www.asco.org/about-asco/press-center/news-releases/trastuzumab-deruxtecan-can-help-some-people-with-advanced-gastric-cancers-live-about-3-months-longer"}],"replication":"Consistent with DESTINY-Gastric01 (OS 12.5 vs 8.4 months vs chemotherapy, third line)."},{"id":"destiny-lung01","kind":"trial","name":"DESTINY-Lung01","aka":[],"tldr":"DESTINY-Lung01 showed that the antibody-drug conjugate trastuzumab deruxtecan shrank tumours in more than half of people whose lung cancer carried a HER2 mutation, which led to the first approved HER2-targeted treatment for lung cancer.","summary":"DESTINY-Lung01 was a two-cohort phase 2 study of trastuzumab deruxtecan, an antibody-drug conjugate that delivers a topoisomerase I inhibitor to HER2-expressing cells, in metastatic non-small-cell lung cancer that had progressed on standard therapy. One cohort enrolled HER2-mutant tumours and the other HER2-overexpressing tumours.\n\nIn the HER2-mutant cohort the drug produced responses in a majority of patients with durable disease control, including in the brain. Interstitial lung disease was the toxicity that needed monitoring. The result led to accelerated approval in the United States in August 2022 for HER2-mutant non-small-cell lung cancer after prior systemic therapy, the first HER2-directed approval in lung cancer. The HER2-overexpressing cohort showed lower activity.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03505710","url":"https://clinicaltrials.gov/study/NCT03505710"}],"tags":["subtype-trials"],"related":[],"cancers":["her2-mutant-nsclc","nsclc","lung-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["bob-li"],"bottlenecks":[],"keyPapers":["paper-destiny-lung01-nejm-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03505710","phase":"2","setting":"Previously treated HER2-mutant or HER2-overexpressing metastatic non-small-cell lung cancer: single-arm trastuzumab deruxtecan","sponsor":"Daiichi Sankyo","result":"High response rate with durable responses in HER2-mutant non-small-cell lung cancer; accelerated approval in August 2022.","started":"2018-05-21","startedType":"actual","yearReported":2022,"enrolled":181,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response (independent central review), HER2-mutant cohort","primary":true,"unit":"%","arms":[{"name":"Trastuzumab deruxtecan 6.4 mg/kg","n":91,"value":55,"note":"95% CI 44 to 65; median follow-up 13.1 months"}],"source":"https://doi.org/10.1056/NEJMoa2112431"},{"endpoint":"Duration of response","unit":"months","arms":[{"name":"Trastuzumab deruxtecan 6.4 mg/kg","n":91,"value":9.3}],"source":"https://doi.org/10.1056/NEJMoa2112431"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Trastuzumab deruxtecan 6.4 mg/kg","n":91,"value":8.2}],"source":"https://doi.org/10.1056/NEJMoa2112431"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Trastuzumab deruxtecan 6.4 mg/kg","n":91,"value":17.8}],"source":"https://doi.org/10.1056/NEJMoa2112431"},{"endpoint":"Adjudicated drug-related interstitial lung disease","unit":"%","arms":[{"name":"Trastuzumab deruxtecan 6.4 mg/kg","n":91,"value":26,"note":"Fatal in 2 patients"}],"source":"https://doi.org/10.1056/NEJMoa2112431"}]},{"id":"destiny-lung02","kind":"trial","name":"DESTINY-Lung02","aka":[],"tldr":"DESTINY-Lung02 confirmed that the antibody-drug conjugate trastuzumab deruxtecan shrinks about half of HER2-mutant lung cancers after chemotherapy and that the lower dose works as well with less lung inflammation.","summary":"DESTINY-Lung02 randomised 152 patients with metastatic HER2-mutant non-small-cell lung cancer that had progressed after platinum chemotherapy to trastuzumab deruxtecan at 5.4 mg/kg or 6.4 mg/kg every three weeks. DESTINY-Lung01 had shown a 55 percent response rate at 6.4 mg/kg but with interstitial lung disease in a quarter of patients.\n\nThe confirmed response rate was 49.0 percent at 5.4 mg/kg (102 patients) and 56.0 percent at 6.4 mg/kg (50 patients), with median durations of response of 16.8 and 5.9 months. Drug-related interstitial lung disease occurred in 12.9 percent at the lower dose and 28.0 percent at the higher dose.\n\nThe FDA had granted accelerated approval in August 2022 on the interim data, the first HER2-directed therapy for lung cancer, at the 5.4 mg/kg dose; DESTINY-Lung04 is testing the drug first line against chemotherapy plus pembrolizumab.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04644237","url":"https://clinicaltrials.gov/study/NCT04644237"},{"label":"Journal of Clinical Oncology 2023","url":"https://doi.org/10.1200/JCO.23.01361"}],"tags":[],"related":[],"cancers":["nsclc","her2-mutant-nsclc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["her2"],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":["ild"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-destiny-lung02-j-thorac-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04644237","phase":"2","setting":"Previously treated metastatic HER2 (ERBB2)-mutant non-small-cell lung cancer: trastuzumab deruxtecan 5.4 mg/kg versus 6.4 mg/kg","sponsor":"Daiichi Sankyo / AstraZeneca","result":"Confirmed response rate 49.0% (5.4 mg/kg) vs 56.0% (6.4 mg/kg); interstitial lung disease 12.9% vs 28.0%.","started":"2021-03-19","startedType":"actual","yearReported":2023,"enrolled":152,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed objective response rate","primary":true,"unit":"%","arms":[{"name":"Trastuzumab deruxtecan 5.4 mg/kg","n":102,"value":49},{"name":"Trastuzumab deruxtecan 6.4 mg/kg","n":50,"value":56}],"source":"https://doi.org/10.1200/JCO.23.01361"}],"replication":"DESTINY-Lung01 (response rate 55 percent at 6.4 mg/kg) preceded it; Beamion LUNG-1 (zongertinib) later showed a 71 percent response with an oral inhibitor in the same population."},{"id":"destiny-pantumor02","kind":"trial","name":"DESTINY-PanTumor02","aka":[],"tldr":"DESTINY-PanTumor02 gave the HER2-directed antibody-drug conjugate Enhertu to 267 patients in seven cohorts of HER2-expressing solid tumours, endometrial and cervical cancer among them. Endometrial cancer responded best, and in April 2024 the FDA granted the first tumour-agnostic HER2 approval, for tumours with the strongest HER2 staining and no satisfactory alternative.","summary":"DESTINY-PanTumor02, trial NCT04482309 sponsored by AstraZeneca and Daiichi Sankyo and published in JCO in 2024, showed that trastuzumab deruxtecan shrinks tumours across seven cohorts of HER2-expressing cancers, with endometrial cancer among the best responders, leading to the first tumour-agnostic HER2 approval. It was a phase 2 of 267 patients with HER2 IHC 2+ or 3+ solid tumours in seven cohorts; the endometrial cohort responded in 57.5 percent overall and 84.6 percent of IHC 3+ cases, the cervical cohort in half, and FDA accelerated approval followed in April 2024 for HER2 IHC 3+ solid tumours with no satisfactory alternative. HER2 testing is now recommended in serous endometrial carcinoma, and how far the tumour-agnostic label should reach is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04482309","url":"https://clinicaltrials.gov/study/NCT04482309"},{"label":"JCO 2024","url":"https://ascopubs.org/doi/10.1200/JCO.23.02005"},{"label":"Enhertu label (openFDA): DESTINY-PanTumor02 efficacy by tumour type","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ENHERTU%22"}],"tags":[],"related":[],"cancers":["endometrial","cervical","endometrial-p53-abnormal","uterine-carcinosarcoma","recurrent-metastatic-cervical-cancer","gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["her2"],"drugs":["trastuzumab-deruxtecan"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":["tumour-agnostic"],"trials":[],"people":["funda-meric-bernstam"],"bottlenecks":[],"keyPapers":["paper-oh-destiny-pantumor02-biliary-pancreatic-esmo-open-2026"],"journals":[],"dependsOn":[],"notes":["Biliary tract cancer cohort: the tumour-agnostic FDA approval of April 2024 (HER2 IHC 3+ solid tumours with no satisfactory alternative) rests on this trial, and the Enhertu label table gives the biliary tract cohort with IHC 3+ as 22 patients with a confirmed response rate of 45.5 percent (95 percent confidence interval 24.4 to 67.8). Across the whole trial the IHC 3+ response rate was 51.4 percent (111 patients) with median duration of response 19.4 months. UK sites: London, Manchester and Sutton (registry). No NICE appraisal of trastuzumab deruxtecan for HER2-positive solid tumours or biliary tract cancer was found in September 2026."],"nct":"NCT04482309","phase":"2","setting":"HER2-expressing (IHC 2+/3+) solid tumours after ≥1 line, seven cohorts including endometrial and cervical: trastuzumab deruxtecan","sponsor":"AstraZeneca / Daiichi Sankyo","result":"Endometrial ORR 57.5% (84.6% in IHC 3+); cervical ORR 50%.","started":"2020-08-18","startedType":"actual","yearReported":2023,"enrolled":267,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate, endometrial cohort","primary":true,"unit":"%","arms":[{"name":"T-DXd (all HER2 IHC 2+/3+)","n":40,"value":57.5},{"name":"T-DXd (IHC 3+ only)","n":13,"value":84.6}],"source":"https://ascopubs.org/doi/10.1200/JCO.23.02005"},{"endpoint":"Objective response rate, cervical cohort","unit":"%","arms":[{"name":"T-DXd (all)","n":40,"value":50}],"source":"https://ascopubs.org/doi/10.1200/JCO.23.02005"},{"endpoint":"Confirmed objective response by independent central review, biliary tract cancer cohort with HER2 IHC 3+ (Enhertu label)","unit":"%","arms":[{"name":"Trastuzumab deruxtecan (biliary tract, IHC 3+)","n":22,"value":45.5,"note":"95% CI 24.4 to 67.8; duration of response range 2.1 to 22.0 months"}],"source":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ENHERTU%22"}]},{"id":"determination","kind":"trial","name":"DETERMINATION","aka":[],"tldr":"DETERMINATION asked whether people with newly diagnosed myeloma still need a stem-cell transplant when modern three-drug therapy and long maintenance are available; transplant kept the disease away for longer, but after several years the two groups had not lived different lengths of time, so the transplant can be delayed for some.","summary":"DETERMINATION (DFCI 10-106) was a US phase 3 trial in transplant-eligible newly diagnosed multiple myeloma. Patients received three cycles of lenalidomide, bortezomib and dexamethasone (RVd) and were then randomised to high-dose melphalan with autologous stem-cell transplant followed by two more RVd cycles, or to five more RVd cycles without transplant. Both arms went on to lenalidomide maintenance until progression, which distinguished it from the parallel French IFM 2009 trial that capped maintenance at one year.\n\nProgression-free survival, the primary endpoint, was significantly longer with early transplant. Overall survival did not differ at the time of the primary report, in part because many patients in the no-transplant arm received a transplant at relapse. The trial supports early transplant as the standard but also a deferred transplant strategy for selected patients.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01208662","url":"https://clinicaltrials.gov/study/NCT01208662"}],"tags":["subtype-trials"],"related":[],"cancers":["myeloma-transplant-eligible","multiple-myeloma"],"sections":[],"technologies":["protac-degrader"],"targets":[],"drugs":["lenalidomide","bortezomib","dexamethasone","melphalan"],"companies":[],"institutions":["dana-farber"],"pathways":[],"terms":[],"trials":[],"people":["paul-richardson"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01208662","phase":"3","setting":"Newly diagnosed multiple myeloma in patients eligible for transplant: lenalidomide, bortezomib and dexamethasone with early autologous stem-cell transplant against the same regimen without transplant, both followed by lenalidomide maintenance until progression","sponsor":"Dana-Farber Cancer Institute","result":"Early autologous transplant added to RVd and lenalidomide maintenance prolonged progression-free survival; overall survival did not differ at the primary analysis.","started":"2010-09","yearReported":2022,"enrolled":729,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"RVD + autologous transplantation","n":365,"value":67.5,"note":"Hazard ratio for progression or death with RVD alone vs transplantation 1.53 (95% CI 1.23 to 1.91), P<0.001; median follow-up 76.0 months"},{"name":"RVD alone","n":357,"value":46.2}],"source":"https://doi.org/10.1056/nejmoa2204925"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"RVD + autologous transplantation","n":365,"value":80.7,"note":"Hazard ratio for death with RVD alone vs transplantation 1.10 (95% CI 0.73 to 1.65)"},{"name":"RVD alone","n":357,"value":79.2}],"source":"https://doi.org/10.1056/nejmoa2204925"},{"endpoint":"Complete response or better","unit":"%","arms":[{"name":"RVD + autologous transplantation","n":365,"value":46.8},{"name":"RVD alone","n":357,"value":42}],"p":"0.99","source":"https://doi.org/10.1056/nejmoa2204925"},{"endpoint":"Grade 3 or higher treatment-related adverse events","unit":"%","arms":[{"name":"RVD + autologous transplantation","value":94.2},{"name":"RVD alone","value":78.2}],"source":"https://doi.org/10.1056/nejmoa2204925"}]},{"id":"determine-trial","kind":"trial","name":"DETERMINE","aka":["DETERMINE trial","Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications using a National Evaluation Platform Trial"],"tldr":"DETERMINE is the United Kingdom's version of TAPUR: people with rare cancers whose tumours carry a change that an already licensed drug targets in another cancer receive that drug through the NHS in a trial, and if a group does well the results are designed to go straight to the bodies that decide NHS funding.","summary":"DETERMINE opened in March 2023, sponsored by Cancer Research UK, run from the Christie and the University of Manchester with Matthew Krebs as chief investigator, and delivered through Cancer Research UK's network of experimental cancer medicine centres. It is open to adults, teenagers and children, which is unusual for a precision medicine platform, and takes patients with a rare cancer, or a rare molecular alteration in a common cancer, for which a licensed drug has a plausible target. Roche supplied the first treatment arms, including alectinib, atezolizumab, entrectinib, trastuzumab with pertuzumab, vemurafenib with cobimetinib and vismodegib, and Novartis joined with further arms.\n\nEach arm is a phase 2/3 with a pre-set response threshold; arms that clear it can expand, and the trial was designed with NHS England so that positive arms produce evidence in a form the health service and its appraisers can act on, including the possibility of routine NHS access for the new indication. Genomic results come from NHS Genomic Medicine Service testing or from research programmes such as TARGET National, so the platform rides on the country's existing sequencing rather than building its own.\n\nNothing has been reported yet; recruitment is under way toward a planned 825 participants. What DETERMINE is meant to change is the fate of small positive signals: in TAPUR and NCI-MATCH they informed guidelines but rarely changed labels or funding, and DETERMINE's wager is that a national single-payer system can turn them into access directly.","status":"recruiting","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT05722886","url":"https://clinicaltrials.gov/study/NCT05722886"}],"tags":[],"related":[],"cancers":["rare-cancers","rare-childhood-cancers"],"sections":[],"technologies":["cgp","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["alectinib","atezolizumab","entrectinib","trastuzumab","pertuzumab","vemurafenib","cobimetinib","vismodegib"],"companies":["roche-genentech","novartis"],"institutions":["the-christie","cruk-manchester-institute","cruk"],"pathways":[],"terms":["master-protocol","basket-umbrella-platform","tumour-agnostic"],"trials":["target-national","tapur"],"people":[],"bottlenecks":["b-rare-cancers"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05722886","phase":"platform","setting":"Adults, teenagers and children in the United Kingdom with rare cancers, or common cancers carrying rare alterations, matched to licensed targeted drugs and immunotherapies outside their approved indications, with a route to NHS access for arms that work","sponsor":"Cancer Research UK, led from the Christie NHS Foundation Trust and the University of Manchester","result":"Recruiting; no arm has reported.","started":"2023-03-01","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"determine-arm04","kind":"trial","name":"DETERMINE arm 04: trastuzumab with pertuzumab in HER2-amplified or mutated rare cancers","aka":["DETERMINE"],"tldr":"DETERMINE is the UK platform that gives existing targeted drugs to people whose rare cancer carries the matching gene change. Its trastuzumab and pertuzumab arm is open to HER2-amplified gallbladder cancer at 27 NHS hospitals, with response and durable benefit as the endpoints.","summary":"DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial, NCT05786716) is a Cancer Research UK umbrella-basket platform for rare adult, paediatric and teenage and young adult cancers with actionable genomic alterations, including common cancers with rare alterations. Treatment arm 04 gives trastuzumab with pertuzumab to patients whose tumours carry HER2 amplification or activating mutations; the registry conditions include gallbladder neoplasms alongside haematological, colorectal, bladder, salivary, lung, pancreatic, ovarian, prostate and skin cancers. Primary outcomes are objective response and durable clinical benefit; 30 patients are planned in this arm with primary completion in October 2029. The arm follows the MyPathway finding of a 23 percent response rate with the same pair in HER2-positive biliary tract cancer and is the route to dual HER2 antibody therapy for UK patients with HER2-amplified gallbladder cancer outside a company trial.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05786716","url":"https://clinicaltrials.gov/study/NCT05786716"}],"tags":[],"related":[],"cancers":["gallbladder","rare-cancers"],"sections":[],"technologies":["monoclonal-antibody","cgp"],"targets":["her2"],"drugs":["trastuzumab","pertuzumab"],"companies":[],"institutions":["cruk"],"pathways":[],"terms":["basket-umbrella-platform","master-protocol","tumour-agnostic"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (27, registry): Belfast City Hospital; University Hospital Birmingham and Birmingham Children's Hospital; Bristol Haematology and Oncology Centre and Bristol Royal Hospital for Children; Addenbrooke's (Cambridge); Velindre Cancer Centre and Cardiff Children's Hospital; Western General (Edinburgh); The Beatson and Royal Hospital for Children (Glasgow); Leicester Royal Infirmary; Alder Hey (Liverpool); University College London Hospital, Guy's Hospital and Great Ormond Street (London) and others."],"nct":"NCT05786716","phase":"2/3","setting":"Adult, paediatric and young adult patients with rare cancers, or common cancers with rare alterations, carrying HER2 amplification or activating mutations, gallbladder neoplasms among the listed conditions: trastuzumab plus pertuzumab, non-randomised treatment arm of the national DETERMINE platform","sponsor":"Cancer Research UK","started":"2023-03-07","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05770102","kind":"trial","name":"DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Mi","aka":["DETERMINE"],"tldr":"A phase 2/3 trial of atezolizumab in colorectal cancer, run by Cancer Research UK, now recruiting.","summary":"DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition is a phase 2/3, interventional study registered as NCT05770102 by Cancer Research UK, with a registry enrolment figure of 30 participants, started 2023-10-25 and due to reach its primary completion in 2029-10. Interventions recorded: Atezolizumab. Conditions listed: Malignancy; Malignant Neoplasm; Lymphoproliferative Disorders; Neoplasms by Histologic Type; Neoplasms by Site; Cancer; Colorectal Neoplasms; Endometrial Neoplasms; Melanoma; Solid Tumours. Primary outcome: Objective Response (OR); Durable Clinical Benefit (DCB). Sites: United Kingdom. United Kingdom sites listed: 27. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05770102","url":"https://clinicaltrials.gov/study/NCT05770102"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Belfast City Hospital (Belfast); University Hospital Birmingham (Birmingham); Birmingham Children's Hospital (Birmingham); Bristol Royal Hospital for Children (Bristol); Bristol Haematology and Oncology Centre (Bristol); Addenbrooke's Hospital (Cambridge); Velindre Cancer Centre (Cardiff); Cardiff Children's Hospital (Cardiff); Western General Hospital (Edinburgh); The Beatson Hospital (Glasgow); Royal Hospital for Children Glasgow (Glasgow); Leicester Royal Infirmary (Leicester) and 15 more."],"nct":"NCT05770102","phase":"2/3","setting":"DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations.","sponsor":"Cancer Research UK","started":"2023-10-25","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05768178","kind":"trial","name":"DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.","aka":["DETERMINE"],"tldr":"A phase 2/3 trial of vemurafenib and cobimetinib in colorectal cancer, run by Cancer Research UK, now recruiting.","summary":"DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers. is a phase 2/3, interventional study registered as NCT05768178 by Cancer Research UK, with a registry enrolment figure of 30 participants, started 2023-03-01 and due to reach its primary completion in 2029-10. Interventions recorded: Vemurafenib; Cobimetinib. Conditions listed: Haematological Malignancy; Melanoma; Thyroid Cancer, Papillary; Ovarian Neoplasms; Colorectal Neoplasms; Laryngeal Neoplasms; Carcinoma, Non-Small-Cell Lung; Glioma; Multiple Myeloma; Erdheim-Chester Disease; Thyroid Carcinoma, Anaplastic; Solid Tumour. Primary outcome: Objective Response (OR); Durable Clinical Benefit (DCB). Colorectal eligibility wording from the registry: \"Patients with QTcF (Corrected QT interval by Fridericia) at screening of \\>450 ms for males and \\>470 ms for females measured on triplicate ECG (if 1/3 readings show \\>450/470 ms then patient is ineligible)\". Sites: United Kingdom. United Kingdom sites listed: 16. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05768178","url":"https://clinicaltrials.gov/study/NCT05768178"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["vemurafenib","cobimetinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Belfast City Hospital (Belfast); University Hospital Birmingham (Birmingham); Bristol Haematology and Oncology Centre (Bristol); Addenbrooke's Hospital (Cambridge); Velindre Cancer Centre (Cardiff); Western General Hospital (Edinburgh); The Beatson Hospital (Glasgow); Leicester Royal Infirmary (Leicester); University College London Hospital (London); Guy's Hospital (London); The Christie Hospital (Manchester); Clatterbridge Cancer Centre (Metropolitan Borough of Wirral) and 4 more."],"nct":"NCT05768178","phase":"2/3","setting":"DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations.","sponsor":"Cancer Research UK","started":"2023-03-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07440290","kind":"trial","name":"DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positi","aka":["DETERMINE"],"tldr":"A phase 2/3 trial of dabrafenib and trametinib in pancreatic cancer, run by Cancer Research UK, now recruiting.","summary":"DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancers. is a phase 2/3, interventional study registered as NCT07440290 by Cancer Research UK, with a registry enrolment figure of 30 participants, started 2026-04-01 and due to reach its primary completion in 2029-10. Interventions recorded: Dabrafenib; Trametinib. Conditions listed: Haematological Malignancy; Malignant Neoplasm; Lymphoproliferative Disorders; Neoplasms by Histologic Type; Neoplasms by Site; Gastrointestinal Cancer; Non-Melanoma Skin Cancer (NMSC); Langerhans Cell Histiocytosis (LCH); Cancer; Erdheim-Chester Disease; Thyroid Carcinoma, Papillary; Ovarian Neoplasms; Colorectal Neoplasms; Laryngeal Neoplasms; Carcinoma, Non-Small Cell-Lung; Glioma; Multiple Myeloma; Thyroid Carcinoma, Anaplastic; Solid Tumour; Pancreatic Diseases. Primary outcome: Objective response (OR); Durable Clinical Benefit (DCB). Sites: United Kingdom. United Kingdom sites listed: 27. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07440290","url":"https://clinicaltrials.gov/study/NCT07440290"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic","kras-wild-type-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["dabrafenib","trametinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Belfast City Hospital (Belfast); University Hospital Birmingham (Birmingham); Birmingham Children's Hospital (Birmingham); Bristol Royal Hospital for Children (Bristol); Bristol Haematology and Oncology Centre (Bristol); Addenbrooke's Hospital (Cambridge); Velindre Cancer Centre (Cardiff); Cardiff Children's Hospital (Cardiff); Western General Hospital (Edinburgh); The Beatson Hospital (Glasgow); Royal Hospital for Children Glasgow (Glasgow); Leicester Royal Infirmary (Leicester) and 15 more."],"nct":"NCT07440290","phase":"2/3","setting":"DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations.","sponsor":"Cancer Research UK","started":"2026-04-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00033332","kind":"trial","name":"Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma","aka":[],"tldr":"A phase 3 trial of Dexamethasone, Pamidronate, Thalidomide and Zoledronic acid in Multiple myeloma, run by National Cancer Institute (NCI), completed.","summary":"Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma is a phase 3 interventional study registered as NCT00033332 by National Cancer Institute (NCI), started 2002-04 and reaching its primary completion in 2006-03. Interventions recorded: dexamethasone, pamidronate disodium, thalidomide, zoledronic acid. Conditions recorded: Multiple Myeloma and Plasma Cell Neoplasm.\n\nLinked to the drug Pamidronate because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00033332","url":"https://clinicaltrials.gov/study/NCT00033332"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["dexamethasone","pamidronate","thalidomide","zoledronic-acid"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00033332","phase":"3","setting":"A Randomized Phase III Trial Of Thalidomide (NSC # 66847) Plus Dexamethasone Versus Dexamethasone In Newly Diagnosed Multiple Myeloma","sponsor":"National Cancer Institute (NCI)","started":"2002-04","enrolledBasis":"registry","outcomes":[]},{"id":"nct00316927","kind":"trial","name":"Dexamethasone, Aspirin, and Diethylstilbestrol in Treating Patients With Locally Advanced or Metastatic Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Aspirin, Dexamethasone and Diethylstilbestrol in Prostate cancer, run by St. Bartholomew's Hospital, completed.","summary":"Dexamethasone, Aspirin, and Diethylstilbestrol in Treating Patients With Locally Advanced or Metastatic Prostate Cancer is a phase 3 interventional study registered as NCT00316927 by St. Bartholomew's Hospital, with 260 participants recorded, started 2002-12. Interventions recorded: acetylsalicylic acid, dexamethasone, diethylstilbestrol. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Diethylstilbestrol because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00316927","url":"https://clinicaltrials.gov/study/NCT00316927"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["aspirin","dexamethasone","diethylstilbestrol"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00316927","phase":"3","setting":"A Randomized Phase III Trial of Dexamethasone and Aspirin (DA) Versus Dexamethasone, Diethylstilbestrol and Aspirin (DAS) in Locally Advanced or Metastatic Cancer of the Prostate - Immediate Versus Deferred Diethylstilbestrol","sponsor":"St. Bartholomew's Hospital","started":"2002-12","enrolled":260,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06382168","kind":"trial","name":"DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia","aka":[],"tldr":"A phase 1/2 trial of Venetoclax in acute myeloid leukaemia, run by Delta-Fly Pharma, Inc., now recruiting.","summary":"DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia is a phase 1/2 interventional study registered as NCT06382168 by Delta-Fly Pharma, Inc., with 39 participants planned, started 2024-06-12 and due to reach its primary completion in 2026-03-31. Interventions recorded: DFP-10917 and Venetoclax.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06382168","url":"https://clinicaltrials.gov/study/NCT06382168"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["venetoclax"],"companies":["delta-fly-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06382168","phase":"1/2","setting":"Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia","sponsor":"Delta-Fly Pharma, Inc.","started":"2024-06-12","startedType":"actual","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01986569","kind":"trial","name":"Diagnostic Accuracy and Safety Study of FES PET/CT in Assessment of ER Status of Recurrent or Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial of FES PET in Breast cancer, run by Asan Medical Center, completed.","summary":"Diagnostic Accuracy and Safety Study of FES PET/CT in Assessment of ER Status of Recurrent or Metastatic Breast Cancer is a phase 3 interventional study registered as NCT01986569 by Asan Medical Center, with 93 participants recorded, started 2013-11 and reaching its primary completion in 2016-11. Interventions recorded: [18F]fluoroestradiol (FES). Conditions recorded: Recurrent Breast Cancer, Stage IV Breast Cancer.\n\nLinked to the technology FES PET because the registry's title names it (\"18f fluoroestradiol pet\") and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01986569","url":"https://clinicaltrials.gov/study/NCT01986569"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["fes-pet"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01986569","phase":"3","setting":"A Phase III, Open Label, Non-randomized, Single Center Study to Evaluate Diagnostic Accuracy and Safety of Fluorine-18 (18F) Fluoroestradiol PET/CT in the Assessment of ER Status of Recurrent or Metastatic Lesions in Patients With Breast Cancer","sponsor":"Asan Medical Center","started":"2013-11","enrolled":93,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06122584","kind":"trial","name":"Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer","aka":[],"tldr":"A phase 3 trial of PSMA-1007 F-18 run by ABX advanced biochemical compounds GmbH in prostate cancer, now recruiting.","summary":"Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer is a phase 3 interventional study registered as NCT06122584 by ABX advanced biochemical compounds GmbH, with 380 participants planned, started 2024-06-13. Conditions listed: Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06122584","url":"https://clinicaltrials.gov/study/NCT06122584"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["psma-1007-f18"],"companies":["abx-advanced-biochemical-compounds"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06122584","phase":"3","setting":"Prospective, Multi-Center Study to Assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer","sponsor":"ABX advanced biochemical compounds GmbH","started":"2024-06-13","startedType":"actual","enrolled":380,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07285057","kind":"trial","name":"Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance","aka":[],"tldr":"A phase 2 trial of Flotufolastat F-18 in Prostate cancer, run by Icahn School of Medicine at Mount Sinai, now recruiting.","summary":"Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance is a phase 2 interventional study registered as NCT07285057 by Icahn School of Medicine at Mount Sinai, with 120 participants planned, started 2026-02-10 and due to reach its primary completion in 2027-05-01. Interventions recorded: rhPSMA-7.3 (18F) PET/CT Imaging (Flotufolastat F18, POSLUMA®), Flotufolastat F18. Conditions recorded: Prostatic Neoplasms, Prostate Cancer, Prostate Adenocarcinoma.\n\nLinked to the drug Flotufolastat F-18 because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07285057","url":"https://clinicaltrials.gov/study/NCT07285057"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-low-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["flotufolastat"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07285057","phase":"2","setting":"Diagnostic Utility of rhPSMA-7.3 (18F) PET /CT Imaging in Patients With Prostate Cancer on Active Surveillance","sponsor":"Icahn School of Medicine at Mount Sinai","started":"2026-02-10","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"diamond","kind":"trial","name":"DIAMOND","aka":[],"tldr":"DIAMOND, a UK trial run from Barts in London, asks whether adding the immunotherapy durvalumab to the antibody-drug conjugate datopotamab deruxtecan helps women with PD-L1-negative metastatic triple-negative breast cancer, the group immunotherapy alone does not help. It opened in October 2025 and is recruiting 140 patients.","summary":"DIAMOND (NCT06954480; also on the ISRCTN registry) is an open-label randomised phase 2 trial sponsored by Queen Mary University of London with AstraZeneca, randomising 140 patients with PD-L1-negative metastatic triple-negative breast cancer to datopotamab deruxtecan with durvalumab or datopotamab deruxtecan alone; the primary endpoint is progression-free survival by RECIST 1.1. It started on 27 October 2025 with primary completion expected in February 2028. Its rationale is the BEGONIA arm 7 result (confirmed response 79 percent with the combination regardless of PD-L1) against the TROPION-Breast02 result for the conjugate alone in a 90 percent PD-L1-negative population, and it is the only randomised test of an ADC plus checkpoint inhibitor restricted to PD-L1-negative disease. Sites: Barts Cancer Institute Centre of Experimental Cancer Medicine and Barts Health NHS Trust, London.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06954480","url":"https://clinicaltrials.gov/study/NCT06954480"},{"label":"ISRCTN registry search: datopotamab deruxtecan plus durvalumab (DIAMOND)","url":"https://www.isrctn.com/search?q=datopotamab+deruxtecan+durvalumab"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":["trop2","pdl1"],"drugs":["datopotamab-deruxtecan","durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["cps"],"trials":["tropion-breast02","nct03742102","tropion-breast05"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 2): Barts Cancer Institute, Centre of Experimental Cancer Medicine, and Barts Health NHS Trust, London."],"nct":"NCT06954480","phase":"2","setting":"PD-L1-negative metastatic triple-negative breast cancer: open-label randomised phase 2 of datopotamab deruxtecan with durvalumab versus datopotamab deruxtecan alone, Barts London","sponsor":"Queen Mary University of London, with AstraZeneca","started":"2025-10-27","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07755124","kind":"trial","name":"Dietary Arginine Deprivation Combined With Chemoradiotherapy for Neoadjuvant Treatment of Rectal Cancer: A Randomized Controlled Trial","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by West China Hospital, not yet recruiting.","summary":"Dietary Arginine Deprivation Combined With Chemoradiotherapy for Neoadjuvant Treatment of Rectal Cancer: A Randomized Controlled Trial is a phase 1/2, randomised interventional study registered as NCT07755124 by West China Hospital, with a registry enrolment figure of 140 participants, started 2026-08-14 and due to reach its primary completion in 2028-08. Interventions recorded: Arginine-Deprived Diet; Short-Course Radiotherapy (SCRT); CAPOX + PD-1 Inhibitor. Conditions listed: Rectal Neoplasms. Primary outcome: Complete Response (CR) Rate (pCR + cCR). Colorectal eligibility wording from the registry: \"* Locally advanced mid-low rectal cancer staged as cT3, cT4, or node-positive by rectal MRI\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07755124","url":"https://clinicaltrials.gov/study/NCT07755124"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07755124","phase":"1/2","setting":"A Randomized Controlled Trial of Dietary Arginine Deprivation Combined With Chemoradiotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer","sponsor":"West China Hospital","started":"2026-08-14","startedType":"estimated","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06698757","kind":"trial","name":"Different Cycles of Preoperative Neoadjuvant Sintilimab in Mismatch-repair Deficient/microsatellite Instability-high, Locally Advanced Colorectal Cancer","aka":["OPEN"],"tldr":"A phase 2 trial of sintilimab in colorectal cancer, run by Yugui Lian, now recruiting.","summary":"Different Cycles of Preoperative Neoadjuvant Sintilimab in Mismatch-repair Deficient/microsatellite Instability-high, Locally Advanced Colorectal Cancer is a phase 2, randomised interventional study registered as NCT06698757 by Yugui Lian, with a registry enrolment figure of 96 participants, started 2024-11-15 and due to reach its primary completion in 2027-11-15. Interventions recorded: Sintilimab. Conditions listed: Colorectal Cancer. Primary outcome: the pathological complete response rate (pCR). Colorectal eligibility wording from the registry: \"* has pathologically confirmed colon cancer or upper rectal cancer (with the lower edge of the tumor more than 10 cm from the anal verge); clinical stage cT3/T4 or N+\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06698757","url":"https://clinicaltrials.gov/study/NCT06698757"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06698757","phase":"2","setting":"Eight Vs Four Cycles of Preoperative Neoadjuvant Sintilimab in Mismatch-repair Deficient/microsatellite Instability-high, Locally Advanced Colorectal Cancer(OPEN): a Multi-center, Open-label, Prospective Randomized Controlled Trial","sponsor":"Yugui Lian","started":"2024-11-15","startedType":"actual","enrolled":96,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06784648","kind":"trial","name":"Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab, Ipilimumab in melanoma and uveal melanoma, run by BioInvent International AB, active and no longer recruiting.","summary":"Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma is a phase 1/2 interventional study registered as NCT06784648 by BioInvent International AB, with 35 participants planned, started 2024-12-11 and due to reach its primary completion in 2025-12-30. Interventions recorded: pembrolizumab (KEYTRUDA®), BI-1607, Ipilimumab (YervoyTM, 50 mg/10 mL solution). Conditions listed: Melanoma Metastatic, Melanoma of Skin, Melanoma BRAF V600E/K Mutated, Melanoma Recurrent. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06784648","url":"https://clinicaltrials.gov/study/NCT06784648"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","uveal-melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","ipilimumab"],"companies":["bioinvent-international"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06784648","phase":"1/2","setting":"An Open-Label, Multicentre Phase 1B/2A Clinical Trial of BI-1607, an Fc-Engineered Monoclonal Antibody to FcγRIIB (CD32B) in Combination With Ipilimumab and Pembrolizumab in Participants With Unresectable or Metastatic Melanoma","sponsor":"BioInvent International AB","started":"2024-12-11","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07646639","kind":"trial","name":"Different-Dose SCRT Plus CAPOX, PD-1 Blockade and IL-2 in LARC","aka":["PRIDE-02"],"tldr":"A phase 2 trial in colorectal cancer, run by The First Affiliated Hospital with Nanjing Medical University, now recruiting.","summary":"Different-Dose SCRT Plus CAPOX, PD-1 Blockade and IL-2 in LARC is a phase 2, randomised interventional study registered as NCT07646639 by The First Affiliated Hospital with Nanjing Medical University, with a registry enrolment figure of 122 participants, started 2026-05-20 and due to reach its primary completion in 2028-12-31. Interventions recorded: Sintilimab + IL-2 Combined with CAPOX; Short-course low-dose radiotherapy; Short-course standard-dose radiotherapy. Conditions listed: Rectal Cancer; Radiotherapy. Primary outcome: Complete remission. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma with the distal margin of the tumor located within 12 cm of the anal verge\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07646639","url":"https://clinicaltrials.gov/study/NCT07646639"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07646639","phase":"2","setting":"Different-Dose Short-Course Radiotherapy Plus CAPOX, Anti-PD-1 Antibody and Interleukin-2 for Locally Advanced Rectal Cancer: A Single-Centre, Prospective, Randomised Phase II Trial","sponsor":"The First Affiliated Hospital with Nanjing Medical University","started":"2026-05-20","startedType":"actual","enrolled":122,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07159217","kind":"trial","name":"Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of disitamab vedotin, pembrolizumab, camrelizumab and other drugs in gallbladder cancer and other biliary tract cancers, run by Peking Union Medical College Hospital, not yet recruiting.","summary":"Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT07159217 by Peking Union Medical College Hospital, with a registry enrolment figure of 65 participants, started 2025-08-30 and due to reach its primary completion in 2027-05-31. Interventions recorded: Disitamab Vedotin, Lenvatinib, Pembrolizumab, Toripalimab, Camrelizumab. Conditions listed: Biliary Tract Cancer, Disitamab Vedotin, Lenvatinib, Immune Checkpoint Inhibitors. Gallbladder cancer is named in the registry entry: \"3. Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07159217","url":"https://clinicaltrials.gov/study/NCT07159217"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["disitamab-vedotin","pembrolizumab","camrelizumab","toripalimab","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07159217","phase":"2","setting":"A Prospective Exploratory Phase II Study of Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for the Treatment of HER2-positive Advanced Biliary Tract Cancer","sponsor":"Peking Union Medical College Hospital","started":"2025-08-30","startedType":"estimated","enrolled":65,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05911295","kind":"trial","name":"Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2","aka":[],"tldr":"A phase 3 trial of Disitamab vedotin, Pembrolizumab, Gemcitabine, Cisplatin and Carboplatin in bladder & urothelial cancer, run by Seagen, a wholly owned subsidiary of Pfizer, active and no longer recruiting.","summary":"Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 is a phase 3 interventional study registered as NCT05911295 by Seagen, a wholly owned subsidiary of Pfizer, with 412 participants enrolled, started 2023-09-22 and due to reach its primary completion in 2027-01-29. Interventions recorded: disitamab vedotin, pembrolizumab, gemcitabine, cisplatin and carboplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05911295","url":"https://clinicaltrials.gov/study/NCT05911295"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["disitamab-vedotin","pembrolizumab","gemcitabine","cisplatin","carboplatin"],"companies":["remegen","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05911295","phase":"3","setting":"An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)","sponsor":"Seagen, a wholly owned subsidiary of Pfizer","started":"2023-09-22","startedType":"actual","enrolled":412,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04567420","kind":"trial","name":"DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)","aka":["DARE"],"tldr":"A phase 2 trial of Palbociclib and Fulvestrant in HR-positive / HER2-negative breast cancer, run by Criterium, Inc., active and no longer recruiting.","summary":"DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE) is a phase 2 interventional study registered as NCT04567420 by Criterium, Inc., with 70 participants enrolled, started 2021-02-09 and due to reach its primary completion in 2027-12-31. Interventions recorded: Palbociclib, Fulvestrant and Adjuvant Therapy.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04567420","url":"https://clinicaltrials.gov/study/NCT04567420"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["palbociclib","fulvestrant"],"companies":["criterium"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04567420","phase":"2","setting":"A Randomized, Phase II Trial of Circulating Tumor DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)","sponsor":"Criterium, Inc.","started":"2021-02-09","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07288112","kind":"trial","name":"DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma","aka":[],"tldr":"A phase 1/2 trial of DOC1021 in melanoma, run by Diakonos Oncology Corporation, now recruiting.","summary":"DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma is a phase 1/2 interventional study registered as NCT07288112 by Diakonos Oncology Corporation, with 35 participants planned, started 2026-04-06 and due to reach its primary completion in 2031-01. Interventions recorded: DOC1021, Tumor resection and pIFN (peginterferon alfa-2a).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07288112","url":"https://clinicaltrials.gov/study/NCT07288112"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["doc1021"],"companies":["diakonos-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07288112","phase":"1/2","setting":"Clinical Study of DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma","sponsor":"Diakonos Oncology Corporation","started":"2026-04-06","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06805305","kind":"trial","name":"DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)","aka":[],"tldr":"A phase 2 trial of Temozolomide in glioma & glioblastoma, run by Diakonos Oncology Corporation, now recruiting.","summary":"DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM) is a phase 2 interventional study registered as NCT06805305 by Diakonos Oncology Corporation, with 180 participants planned, started 2025-03-17 and due to reach its primary completion in 2030-03. Interventions recorded: DOC1021, Tumor resection, Temodar (Temozolomide) and SOC cranial radiation.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06805305","url":"https://clinicaltrials.gov/study/NCT06805305"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":["temozolomide","doc1021"],"companies":["diakonos-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06805305","phase":"2","setting":"Randomized Study of DOC1021 Dendritic Cell Immunotherapy in Combination With Standard of Care for Newly Diagnosed Adult Glioblastoma","sponsor":"Diakonos Oncology Corporation","started":"2025-03-17","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00077311","kind":"trial","name":"Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Darbepoetin alfa, Pegfilgrastim, Cisplatin and Docetaxel in Lung cancer, run by Alliance for Clinical Trials in Oncology, completed.","summary":"Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT00077311 by Alliance for Clinical Trials in Oncology, with 160 participants recorded, started 2004-08 and reaching its primary completion in 2006-07. Interventions recorded: darbepoetin alfa, pegfilgrastim, cisplatin, docetaxel, BNP7787. Conditions recorded: Anemia, Drug/Agent Toxicity by Tissue/Organ, Lung Cancer, Neutropenia.\n\nLinked to the drug Darbepoetin alfa because the registry names it among its interventions and Lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00077311","url":"https://clinicaltrials.gov/study/NCT00077311"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["darbepoetin-alfa","pegfilgrastim","cisplatin","docetaxel"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00077311","phase":"2","setting":"A Phase II Randomized Study Of Dose-Dense Docetaxel And Cisplatin Every Two Weeks With Pegfilgrastim And Darbepoetin Alfa With And Without The Chemoprotector BNP7787 In Patients With Advanced Non-Small Cell Lung Cancer","sponsor":"Alliance for Clinical Trials in Oncology","started":"2004-08","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07361484","kind":"trial","name":"Docetaxel Plus Plinabulin vs Docetaxel Plus Placebo in Advanced/Metastatic Non-Squamous NSCLC After PD-1/PD-L1 Therapy and Platinum Chemotherapy (DUBLIN-4)","aka":["DUBLIN-4"],"tldr":"A phase 3 trial of docetaxel in lung cancer, run by BeyondSpring Pharmaceuticals Inc., not yet recruiting.","summary":"Docetaxel Plus Plinabulin vs Docetaxel Plus Placebo in Advanced/Metastatic Non-Squamous NSCLC After PD-1/PD-L1 Therapy and Platinum Chemotherapy (DUBLIN-4) is a phase 3, randomised interventional study registered as NCT07361484 by BeyondSpring Pharmaceuticals Inc., with a registry enrolment figure of 442 participants, started 2026-06-01 and due to reach its primary completion in 2029-06-01. Interventions recorded: Plinabulin; Docetaxel; Placebo (matching plinabulin placebo). Conditions listed: Non-Small Cell Lung Cancer; Non-squamous Non-Small Cell Lung Cance. Primary outcome: Overall Survival (OS). Lung eligibility wording from the registry: \"Non-squamous NSCLC with EGFR, ALK, ROS and RET wild type who have been diagnosed by histopathological and/or cytological examination as being ineligible for surgical treatment and have locally advanced (stage IIIb) or metastatic (stage IV) diseases, or have recurrent and progressive disease after lo\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07361484","url":"https://clinicaltrials.gov/study/NCT07361484"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","alk-positive-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":["beyondspring"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07361484","phase":"3","setting":"A Global, Multicenter, Randomized, Double-blinded, Phase 3 Study of Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer With EGFR, ALK, ROS, and RET Wild Type After Progressing on Prior Immunotherapy (Anti-PD-1/L1 Antibody) and Platinum-based Chemotherapy (DUBLIN-4)","sponsor":"BeyondSpring Pharmaceuticals Inc.","started":"2026-06-01","startedType":"estimated","enrolled":442,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02003209","kind":"trial","name":"Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer","aka":[],"tldr":"A phase 3 trial of Carboplatin, Docetaxel, Goserelin / leuprolide, Pertuzumab, HLX11, Trastuzumab and Trastuzumab biosimilars in Breast cancer, run by National Cancer Institute (NCI), completed.","summary":"Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer is a phase 3 interventional study registered as NCT02003209 by National Cancer Institute (NCI), with 315 participants recorded, started 2014-02-18 and reaching its primary completion in 2016-10-31. Interventions recorded: Aromatase Inhibition Therapy, Carboplatin, Cytology Specimen Collection Procedure, Docetaxel, Goserelin Acetate, Laboratory Biomarker Analysis, Pertuzumab, Quality-of-Life Assessment, Therapeutic Conventional Surgery, Trastuzumab, Whole Breast Irradiation. Conditions recorded: HER2-Positive Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma, Stage IB Breast Cancer AJCC v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7.\n\nLinked to the drug Trastuzumab biosimilars because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02003209","url":"https://clinicaltrials.gov/study/NCT02003209"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["carboplatin","docetaxel","goserelin","pertuzumab","hlx11","trastuzumab","trastuzumab-biosimilars"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02003209","phase":"3","setting":"A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients With Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated With Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation","sponsor":"National Cancer Institute (NCI)","started":"2014-02-18","startedType":"actual","yearReported":2023,"enrolled":315,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percent of Patients With Pathological Complete Response (pCR) in the Breast and Post Therapy Lymph Nodes","primary":true,"unit":"%","arms":[{"name":"Arm I (Combination Chemotherapy, Surgery, Radiation)","n":153,"value":41.2,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-06-12), not from a publication"},{"name":"Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation)","n":155,"value":45.8}],"source":"https://clinicaltrials.gov/study/NCT02003209?tab=results"}]},{"id":"nct05724563","kind":"trial","name":"Domvanalimab and Zimberelimab in Advanced Liver Cancers","aka":[],"tldr":"A phase 2 trial of zimberelimab and domvanalimab in gallbladder cancer and other biliary tract cancers, run by University of Texas Southwestern Medical Center, active and no longer recruiting.","summary":"Domvanalimab and Zimberelimab in Advanced Liver Cancers is a phase 2 interventional study registered as NCT05724563 by University of Texas Southwestern Medical Center, with a registry enrolment figure of 58 participants, started 2023-06-12 and due to reach its primary completion in 2027-12-31. Interventions recorded: Zimberelimab, Domvanalimab. Conditions listed: Hepatobiliary Cancer, Liver Cancer, Cholangiocarcinoma, Hepatocellular Carcinoma. Gallbladder cancer is named in the registry entry: \"1. Patient must have a histologically confirmed diagnosis consistent with HCC or bile duct cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancers); known fibrolamella\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05724563","url":"https://clinicaltrials.gov/study/NCT05724563"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["zimberelimab","domvanalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05724563-nat-commun-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05724563","phase":"2","setting":"Phase II Basket Trial of Domvanalimab (AB154) and Zimberelimab (AB122) in Advanced Hepatobiliary Cancers","sponsor":"University of Texas Southwestern Medical Center","started":"2023-06-12","startedType":"actual","enrolled":58,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06275958","kind":"trial","name":"DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer","aka":["DOSAGE"],"tldr":"A phase 3 trial in colorectal cancer, run by Leiden University Medical Center, now recruiting.","summary":"DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT06275958 by Leiden University Medical Center, with a registry enrolment figure of 587 participants, started 2024-07-01 and due to reach its primary completion in 2028-06. Interventions recorded: Doublet Chemotherapy, Standard Dose (100%); Doublet Chemotherapy, Dose-reduced (75%); Monotherapy, Standard Dose (100%); Monotherapy, Dose-reduced (75%). Conditions listed: Older Patients; Colorectal Cancer; Metastatic Cancer; Candidates for Palliative Chemotherapy. Primary outcome: Progression-Free Survival. Colorectal eligibility wording from the registry: \"* Patients aged 70 years or older with colorectal cancer and distant metastases without localized treatment options\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06275958","url":"https://clinicaltrials.gov/study/NCT06275958"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06275958","phase":"3","setting":"DOSAGE Study: a Multicenter Randomized Phase III Trial of DOSe-reduced Chemotherapy for Advanced Colorectal Cancer in Older Patients","sponsor":"Leiden University Medical Center","started":"2024-07-01","startedType":"actual","enrolled":587,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06239194","kind":"trial","name":"Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of MDX2001 in biliary tract cancer, cervical cancer, colorectal cancer, endometrial cancer, oesophageal cancer and gastric & gastro-oesophageal junction cancer, run by ModeX Therapeutics, An OPKO Health Company, now recruiting.","summary":"Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06239194 by ModeX Therapeutics, An OPKO Health Company, with 285 participants planned, started 2024-06-12 and due to reach its primary completion in 2028-08. Interventions recorded: MDX2001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06239194","url":"https://clinicaltrials.gov/study/NCT06239194"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma","cervical","colorectal","endometrial","esophageal","gastric"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["modex-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06239194","phase":"1/2","setting":"A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors","sponsor":"ModeX Therapeutics, An OPKO Health Company","started":"2024-06-12","startedType":"actual","enrolled":285,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07249905","kind":"trial","name":"Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma","aka":[],"tldr":"A phase 1/2 trial of MDX2003 in non-Hodgkin lymphoma, waldenström macroglobulinaemia, diffuse large B-cell lymphoma and follicular lymphoma, run by ModeX Therapeutics, An OPKO Health Company, now recruiting.","summary":"Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma is a phase 1/2 interventional study registered as NCT07249905 by ModeX Therapeutics, An OPKO Health Company, with 180 participants planned, started 2026-04-13 and due to reach its primary completion in 2028-01. Interventions recorded: MDX2003.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07249905","url":"https://clinicaltrials.gov/study/NCT07249905"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","waldenstrom","dlbcl","follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["modex-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07249905","phase":"1/2","setting":"A Phase 1/2 Clinical Study Evaluating MDX2003 in Participants With Relapsed, Progressive, or Refractory B-Cell Malignancies","sponsor":"ModeX Therapeutics, An OPKO Health Company","started":"2026-04-13","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04140500","kind":"trial","name":"Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of RO7247669 in melanoma, non-small-cell lung cancer and oesophageal cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT04140500 by Hoffmann-La Roche, with 170 participants enrolled, started 2019-11-11 and due to reach its primary completion in 2027-06-30. Interventions recorded: RO7247669.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04140500","url":"https://clinicaltrials.gov/study/NCT04140500"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","nsclc","esophageal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04140500","phase":"1/2","setting":"An Open Label, Multicenter, Dose Escalation, Phase 1 Study to Evaluate Safety/Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti Tumor Activity of RO7247669, a PD1-LAG3 Bispecific Antibody, in Patients With Advanced and/or Metastatic Solid Tumors","sponsor":"Hoffmann-La Roche","started":"2019-11-11","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06283719","kind":"trial","name":"Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in P","aka":[],"tldr":"A phase 1/2 trial of ZG006 in small-cell lung cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, now recruiting.","summary":"Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT06283719 by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, with 265 participants planned, started 2024-09-02 and due to reach its primary completion in 2026-04. Interventions recorded: ZG006. Conditions listed: Small Cell Lung Cancer, Neuroendocrine Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06283719","url":"https://clinicaltrials.gov/study/NCT06283719"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["zg006"],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06283719","phase":"1/2","setting":"A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","started":"2024-09-02","startedType":"actual","enrolled":265,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06440057","kind":"trial","name":"Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma.","aka":[],"tldr":"A phase 1/2 trial of ZG006 in neuroendocrine tumours, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, now recruiting.","summary":"Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma. is a phase 1/2 interventional study registered as NCT06440057 by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, with 78 participants planned, started 2024-08-29 and due to reach its primary completion in 2026-05. Interventions recorded: ZG006.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06440057","url":"https://clinicaltrials.gov/study/NCT06440057"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine"],"sections":[],"technologies":[],"targets":[],"drugs":["zg006"],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06440057","phase":"1/2","setting":"A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Neuroendocrine Carcinoma.","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","started":"2024-08-29","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05431270","kind":"trial","name":"Dose Escalation/Expansion Study of Mavrostobart (PT199), an Anti-CD73 mAb, Administered Alone and in Combination With a PD-1 Inhibitor or Chemotherapy","aka":["MORNINGSTAR"],"tldr":"A phase 1/2 trial of Mavrostobart, Tislelizumab, Gemcitabine in non-small-cell lung cancer and small-cell lung cancer, run by Phanes Therapeutics, now recruiting.","summary":"Dose Escalation/Expansion Study of Mavrostobart (PT199), an Anti-CD73 mAb, Administered Alone and in Combination With a PD-1 Inhibitor or Chemotherapy (the MORNINGSTAR Study) is a phase 1/2 interventional study registered as NCT05431270 by Phanes Therapeutics, with 40 participants planned, started 2022-08-11 and due to reach its primary completion in 2027-12. Interventions recorded: Mavrostobart (PT199), Tislelizumab, Gemcitabine + nab-Paclitaxel, Docetaxel, Pemetrexed. Conditions listed: Non Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05431270","url":"https://clinicaltrials.gov/study/NCT05431270"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["mavrostobart","tislelizumab","gemcitabine","paclitaxel","docetaxel","pemetrexed"],"companies":["phanes-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05431270","phase":"1/2","setting":"A Phase 1, Open-Label, Dose Escalation and Expansion Study of Mavrostobart (PT199) Administered Alone in Adult Patients With Advanced Solid TuMORs, in CombiNation With a Checkpoint INhibitor TreatinG Wild-type Non-Small Cell Lung Cancer, or in Combination With ChemoTherapy for Metastatic or Advanced PAncreatic Ductal AdenocaRcinoma (MORNINGSTAR)","sponsor":"Phanes Therapeutics","started":"2022-08-11","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06630624","kind":"trial","name":"Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM","aka":["INJECTABL-II"],"tldr":"A phase 1/2 trial in colorectal cancer, run by M.R. Meijerink, now recruiting.","summary":"Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM is a phase 1/2, interventional study registered as NCT06630624 by M.R. Meijerink, with a registry enrolment figure of 120 participants, started 2024-07-10 and due to reach its primary completion in 2029-08-01. Interventions recorded: IP-001. Conditions listed: Colorectal Cancer; Liver Metastases; Liver Metastasis Colon Cancer. Primary outcome: Maximum Tolerated Dose (MTD) (Phase 1); 1-Year Distant Progression Free Survival (DPFS) (Phase 2 part 1); Disease Control Rate (DCR) (Phase 2 part 2). Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06630624","url":"https://clinicaltrials.gov/study/NCT06630624"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["thermal-ablation"],"targets":[],"drugs":[],"companies":["angiodynamics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06630624","phase":"1/2","setting":"INJECTABL-II: Dose Finding, Efficacy and Immunological Response of a Novel Immuno-Adjuvant (IP-001) Following Microwave Ablation or Irreversible Electroporation for Colorectal Liver Metastases.","sponsor":"M.R. Meijerink","started":"2024-07-10","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06475352","kind":"trial","name":"Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme","aka":["FUDOSE"],"tldr":"A phase 2 trial in colorectal cancer, run by UNICANCER, now recruiting.","summary":"Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme is a phase 2, interventional study registered as NCT06475352 by UNICANCER, with a registry enrolment figure of 400 participants, started 2025-01-20 and due to reach its primary completion in 2027-04. Interventions recorded: FOLFOX regimen; CAPOX regimen. Conditions listed: Digestive Cancer; Colorectal Cancer. Primary outcome: Proportion of fluoropyrimidine-induced grade ≥ 3 haematological and gastrointestinal toxicity after 2 cycles. Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06475352","url":"https://clinicaltrials.gov/study/NCT06475352"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06475352","phase":"2","setting":"Dihydropyrimidine Dehydrogenase (DPD) Phenotype-guided Dose Individualization of Fluoropyrimidine-based Chemotherapy in DPD Deficient Patients With Gastrointestinal Cancers","sponsor":"UNICANCER","started":"2025-01-20","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02174549","kind":"trial","name":"Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer","aka":[],"tldr":"A phase 1/2 trial of Tirapazamine in hepatocellular carcinoma and neuroendocrine tumours, run by Teclison Ltd., now recruiting.","summary":"Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer is a phase 1/2 interventional study registered as NCT02174549 by Teclison Ltd., with 25 participants planned, started 2014-09 and due to reach its primary completion in 2028-03-31. Interventions recorded: Tirapazamine and Conventional Transarterial Embolization (TAE).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02174549","url":"https://clinicaltrials.gov/study/NCT02174549"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","neuroendocrine"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["teclison"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02174549","phase":"1/2","setting":"Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer","sponsor":"Teclison Ltd.","started":"2014-09","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07015892","kind":"trial","name":"Dose-Escalation Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized Trial","aka":["ESCALADOR"],"tldr":"A phase 3 trial in lung cancer, run by Instituto de Investigación Biomédica de Salamanca, now recruiting.","summary":"Dose-Escalation Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized Trial is a phase 3, randomised interventional study registered as NCT07015892 by Instituto de Investigación Biomédica de Salamanca, with a registry enrolment figure of 300 participants, started 2026-03-01 and due to reach its primary completion in 2028-09-01. Interventions recorded: Thoracic Radiotherapy 45 Gy BID; Thoracic Radiotherapy 60 Gy BID; Thoracic Radiotherapy SIB 45-54 Gy BID. Conditions listed: Small Cell Lung Carcinoma. Primary outcome: Progression-Free Survival (PFS). Lung eligibility wording from the registry: \"* Histologically confirmed diagnosis of small cell lung cancer (SCLC)\". Sites: Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07015892","url":"https://clinicaltrials.gov/study/NCT07015892"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["limited-stage-sclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07015892","phase":"3","setting":"Phase III Randomized Clinical Trial to Evaluate the Efficacy and Safety of Twice-Daily Hyperfractionated Dose-Escalated Thoracic Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer (ESCALADOR Study)","sponsor":"Instituto de Investigación Biomédica de Salamanca","started":"2026-03-01","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05751798","kind":"trial","name":"Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas","aka":[],"tldr":"A phase 1/2 trial of OSE2101 in non-small-cell lung cancer and small-cell lung cancer, run by OSE Immunotherapeutics, now recruiting.","summary":"Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas is a phase 1/2 interventional study registered as NCT05751798 by OSE Immunotherapeutics, with 41 participants planned, started 2022-12-20 and due to reach its primary completion in 2029-12. Interventions recorded: Part A: OSE-279 100mg, Part A: OSE-279 300mg, Part A: OSE-279 600mg, Part B: OSE-279 600 mg and OSE2101, Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positive. Conditions listed: Solid Advanced Tumor, Lymphoma, NSCLC (Non-small Cell Lung Cancer). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05751798","url":"https://clinicaltrials.gov/study/NCT05751798"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ose2101"],"companies":["ose-immunotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05751798-eur-j-cancer-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05751798","phase":"1/2","setting":"A Multicenter, Phase 1/2, Dose-finding and Dose Expansion Study of OSE-279, a PD-1 Blocking Monoclonal Antibody, in Subjects With Advanced Solid Tumors or Lymphomas","sponsor":"OSE Immunotherapeutics","started":"2022-12-20","startedType":"actual","enrolled":41,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06333314","kind":"trial","name":"Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI","aka":["Pan-MSI-ACSE"],"tldr":"A phase 2 trial of dostarlimab in pancreatic cancer, run by UNICANCER, now recruiting.","summary":"Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI is a phase 2, randomised interventional study registered as NCT06333314 by UNICANCER, with a registry enrolment figure of 120 participants, started 2024-07-23 and due to reach its primary completion in 2028-10. Interventions recorded: Dostarlimab; Chemotherapy. Conditions listed: Pancreatic Adenocarcinoma; Ampulla of Vater Carcinoma; Adrenocortical Carcinoma; Neuroendocrine Carcinoma; Soft Tissue Sarcoma; Small Bowel Adenocarcinoma; Duodenum Adenocarcinoma; Gastric Adenocarcinoma. Primary outcome: Progression-free survival. Pancreatic eligibility wording from the registry: \"Histologically proven, dMMR/MSI-H solid tumors that are not colorectal or endometrial cancers and including one of the following: duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction adenocarcinoma with CPS\\<5, pancreatic adenocarcinoma, ampulla of Vater adenocarcinoma, adrenoc\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06333314","url":"https://clinicaltrials.gov/study/NCT06333314"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac","msi-high-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06333314","phase":"2","setting":"Dostarlimab as First-line Treatment for Patients With dMMR/MSI (Non-colorectal/Non-endometrial) Locally Advanced or Metastatic Cancer: a Randomized Phase 2 Trial (Cohort Pan-MSI ACSE) With Crossover in the Standard Arm at Progression","sponsor":"UNICANCER","started":"2024-07-23","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06757244","kind":"trial","name":"DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer","aka":["DOVIPA"],"tldr":"A phase 2 trial of dostarlimab in pancreatic cancer, run by Hopital Foch, now recruiting.","summary":"DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer is a phase 2, interventional study registered as NCT06757244 by Hopital Foch, with a registry enrolment figure of 35 participants, started 2025-02-18 and due to reach its primary completion in 2028-02-18. Interventions recorded: Dostarlimab; Vitamin D3 (Cholecalciferol); mFOLFIRINOX Treatment Regimen; LV5FU2. Conditions listed: Pancreas Neoplasms. Primary outcome: Objective response rate (ORR) according to Response Evaluation Criteria version 1.1 (RECIST 1.1) in patients with pancreatic adenocarcinoma and measurable disease. Pancreatic eligibility wording from the registry: \"Histologically confirmed metastatic Stage IV adenocarcinoma of the pancreas\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06757244","url":"https://clinicaltrials.gov/study/NCT06757244"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06757244","phase":"2","setting":"DOVIPA, a Phase II Study Evaluating Efficacy and Safety of DOstarlimab and Oral VItamin D3 With Folinic Acid, 5FU, Irinotecan Plus Oxalipaltin (mFOLFIRINOX) in Non Pretreated Metastatic PAncreatic Cancer","sponsor":"Hopital Foch","started":"2025-02-18","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02488967","kind":"trial","name":"Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 3 trial of carboplatin, cyclophosphamide, doxorubicin and paclitaxel / nab-paclitaxel in triple-negative breast cancer, run by NRG Oncology, active but no longer recruiting.","summary":"Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer is a phase 3, randomised interventional study registered as NCT02488967 by NRG Oncology, with a registry enrolment figure of 782 participants, started 2015-07-26 and due to reach its primary completion in 2025-12-31. Interventions recorded: Carboplatin; Cyclophosphamide; Doxorubicin Hydrochloride; Laboratory Biomarker Analysis; Paclitaxel. Conditions listed: Breast Adenocarcinoma; Estrogen Receptor Negative; HER2/Neu Negative; Progesterone Receptor Negative; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIC Breast Cancer; Triple-Negative Breast Carcinoma. Sites: Canada, United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02488967","url":"https://clinicaltrials.gov/study/NCT02488967"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","cyclophosphamide","doxorubicin","paclitaxel"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02488967","phase":"3","setting":"A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel With or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer","sponsor":"NRG Oncology","started":"2015-07-26","enrolled":782,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06313086","kind":"trial","name":"DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer","aka":[],"tldr":"A phase 3 trial of Trastuzumab emtansine in her2-positive breast cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., now recruiting.","summary":"DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer is a phase 3 interventional study registered as NCT06313086 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., with 442 participants planned, started 2024-03-13 and due to reach its primary completion in 2025-12. Interventions recorded: DP303c, trastuzumab emtansine. Conditions listed: HER2-positive Breast Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06313086","url":"https://clinicaltrials.gov/study/NCT06313086"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-emtansine"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06313086","phase":"3","setting":"A Multicentre, Randomized, Open-label, Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303c Versus Trastuzumab Emtansine in Patients With HER2-positive Advanced Breast Cancer","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","started":"2024-03-13","startedType":"actual","enrolled":442,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04920617","kind":"trial","name":"DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymp","aka":["VITALIZE"],"tldr":"A phase 2 trial of Pembrolizumab, Cyclophosphamide in diffuse large b-cell lymphoma, run by ImmunoVaccine Technologies, Inc. (IMV Inc.), now recruiting.","summary":"DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma is a phase 2 interventional study registered as NCT04920617 by ImmunoVaccine Technologies, Inc. (IMV Inc.), with 102 participants planned, started 2021-06-18 and due to reach its primary completion in 2024-10. Interventions recorded: DPX-Survivac, Pembrolizumab, CPA. Conditions listed: Relapsed Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04920617","url":"https://clinicaltrials.gov/study/NCT04920617"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["pembrolizumab","cyclophosphamide"],"companies":["immunovaccine"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04920617","phase":"2","setting":"A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE)","sponsor":"ImmunoVaccine Technologies, Inc. (IMV Inc.)","started":"2021-06-18","startedType":"actual","enrolled":102,"enrolledBasis":"registry","outcomes":[]},{"id":"drammatic","kind":"trial","name":"DRAMMATIC","aka":["SWOG S1803","S1803"],"tldr":"DRAMMATIC asks two questions about maintenance treatment after a stem cell transplant for myeloma: whether adding daratumumab to lenalidomide helps people live longer, and whether those whose tests show no detectable disease after two years can safely stop; it is still running with about 1,100 patients.","summary":"DRAMMATIC (SWOG S1803) is a US National Clinical Trials Network phase 3 trial in patients with multiple myeloma after autologous stem cell transplant, randomised to lenalidomide maintenance or lenalidomide with subcutaneous daratumumab. After two years, patients who are MRD-negative are randomised a second time to continue or stop maintenance, making the trial one of the first to test MRD-guided discontinuation. The primary endpoint is overall survival, assessed for up to 15 years.\n\nThe registry lists an estimated 1,100 participants, active and no longer recruiting, with primary completion in 2032 and no results. The corpus's multiple myeloma page cites DRAMMATIC with MASTER for MRD-guided discontinuation in trials.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04071457","url":"https://clinicaltrials.gov/study/NCT04071457"}],"tags":["soc-trials"],"related":[],"cancers":["multiple-myeloma","myeloma-transplant-eligible"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":["daratumumab","lenalidomide"],"companies":["johnson-johnson","swog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04071457","phase":"3","setting":"Multiple myeloma after autologous stem cell transplant: maintenance with lenalidomide alone or with subcutaneous daratumumab, then a second randomisation in patients who are MRD-negative after two years between continuing and stopping maintenance, with overall survival as the primary endpoint","sponsor":"SWOG Cancer Research Network","started":"2019-08-13","startedType":"actual","enrolled":1100,"enrolledBasis":"registry","outcomes":[]},{"id":"dream3r","kind":"trial","name":"DREAM3R","aka":[],"tldr":"The phase 3 test of durvalumab with chemotherapy was stopped early and did not meet its goal, despite an encouraging earlier study.","summary":"DREAM3R, trial NCT04334759 sponsored by ALTG and PrECOG and reported in 2026, was the phase 3 test of durvalumab with platinum and pemetrexed as first-line treatment for unresectable pleural mesothelioma, and it was stopped early without meeting its primary overall survival endpoint despite an encouraging single-arm predecessor. It followed the DREAM and PrE0505 phase 2 studies, whose signals it did not confirm, with medians and hazard ratio pending publication after presentation at ESMO 2025. OnCo links it to mesothelioma, durvalumab, pemetrexed and Anna K. Nowak. Together with the modest effect in IND.227 it suggests the chemo-immunotherapy benefit in mesothelioma is real but small and histology-dependent, so first-line immunotherapy in the disease now rests on CheckMate 743 and IND.227.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04334759","url":"https://clinicaltrials.gov/study/NCT04334759"},{"label":"2026 trial landscape (MesoWatch)","url":"https://mesowatch.org/news/2026/03/mesothelioma-clinical-trial-results-compared/"}],"tags":["lesson:single-arm-to-phase-3"],"related":[],"cancers":["mesothelioma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["anna-nowak"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04334759","phase":"3","setting":"Unresectable pleural mesothelioma, first line: durvalumab + platinum-pemetrexed vs chemotherapy","sponsor":"ALTG / PrECOG","result":"Stopped early; primary endpoint not met.","started":"2021-02-18","startedType":"actual","yearReported":2026,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Durvalumab + platinum-pemetrexed","note":"Trial closed early; primary OS endpoint not met at the analysis presented at ESMO 2025. Medians and hazard ratio pending publication."},{"name":"Platinum-pemetrexed"}],"source":"https://clinicaltrials.gov/study/NCT04334759"}],"replication":"Did not confirm the single-arm PrE0505 and DREAM phase 2 signals; chemo-immunotherapy in mesothelioma rests on the ipilimumab-nivolumab (CheckMate 743) and IND.227 pembrolizumab data instead."},{"id":"dreamm-7","kind":"trial","name":"DREAMM-7","aka":[],"tldr":"The trial that brought the withdrawn myeloma ADC back, beating a daratumumab-based standard on progression and survival.","summary":"DREAMM-7, trial NCT04246047 sponsored by GSK and published in the New England Journal of Medicine in 2024, is the trial that brought the withdrawn myeloma antibody-drug conjugate belantamab mafodotin back, beating a daratumumab-based standard on both progression and survival. It randomised 494 patients with relapsed myeloma after at least one line to belantamab or daratumumab, each with bortezomib and dexamethasone, met its primary progression-free survival endpoint with a large effect and showed a survival benefit in the 2024 update, while ocular events in about eighty percent were managed by dose holds; the drug was re-approved in the United States and European Union in 2025. OnCo links it to multiple myeloma, belantamab mafodotin, bortezomib and Sagar Lonial, and DREAMM-8 is concordant. Whether the eye toxicity is acceptable when bispecifics offer alternatives is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04246047","url":"https://clinicaltrials.gov/study/NCT04246047"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["belantamab-mafodotin","bortezomib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sagar-lonial"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04246047","phase":"3","setting":"Relapsed myeloma after ≥1 line: belantamab-Vd vs Dara-Vd","sponsor":"GSK","result":"PFS 36.6 vs 13.4 months, HR 0.41; OS HR 0.58.","started":"2020-05-07","startedType":"actual","yearReported":2024,"enrolled":494,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Belantamab-Vd","n":243,"value":36.6},{"name":"Dara-Vd","n":251,"value":13.4}],"hr":0.41,"ci":[0.31,0.53],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2405090"},{"endpoint":"Overall survival","arms":[{"name":"Belantamab-Vd"},{"name":"Dara-Vd"}],"hr":0.58,"ci":[0.43,0.79],"source":"https://doi.org/10.1056/NEJMoa2405090"}],"replication":"DREAMM-8 (belantamab-Pd vs Pom-Vd) concordant, PFS HR 0.52."},{"id":"dreamm-8","kind":"trial","name":"DREAMM-8","aka":[],"tldr":"DREAMM-8 is the second confirmatory win for belantamab, in lenalidomide-exposed patients.","summary":"DREAMM-8, trial NCT04484623 sponsored by GSK and published in the New England Journal of Medicine in 2024, is the second confirmatory win for belantamab mafodotin, in relapsed myeloma patients after at least one line including lenalidomide. It randomised 302 patients to belantamab with pomalidomide and dexamethasone or bortezomib with the same partners and met its primary progression-free survival endpoint at twelve months with a favourable survival trend, supporting the 2025 US approval with pomalidomide and dexamethasone. OnCo links it to multiple myeloma, belantamab mafodotin and Sagar Lonial, and the result is concordant with DREAMM-7. Whether the pomalidomide combination or the bortezomib combination is the better use of the drug is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04484623","url":"https://clinicaltrials.gov/study/NCT04484623"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["belantamab-mafodotin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sagar-lonial"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04484623","phase":"3","setting":"Relapsed myeloma after ≥1 line including lenalidomide: belantamab-Pd vs Pom-Vd","sponsor":"GSK","result":"PFS HR 0.52.","started":"2020-10-01","startedType":"actual","yearReported":2024,"enrolled":302,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 12 months","primary":true,"unit":"%","arms":[{"name":"Belantamab-Pd","n":155,"value":71},{"name":"Pom-Vd","n":147,"value":51}],"hr":0.52,"ci":[0.37,0.73],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2403407"}]},{"id":"dreamseq","kind":"trial","name":"DREAMseq (ECOG-ACRIN EA6134)","aka":[],"tldr":"Settled the order question: for BRAF-mutant melanoma, start with immunotherapy and save the targeted pills for later.","summary":"DREAMseq, ECOG-ACRIN trial EA6134, NCT02224781, sponsored by ECOG-ACRIN and the NCI and reported in 2021, settled the order question in BRAF-mutant metastatic melanoma: start with immunotherapy and save the targeted tablets for later. It randomised 265 patients to nivolumab plus ipilimumab followed by dabrafenib plus trametinib at progression, or the reverse sequence, and was stopped early for benefit when two-year overall survival clearly favoured immunotherapy first, since targeted therapy remained effective after immunotherapy while immunotherapy after BRAF and MEK failure performed poorly. OnCo links it to BRAF, PD-1 and CTLA-4 as targets, the drugs, ECOG-ACRIN and the pairing that places immunotherapy first, and the Italian phase 2 SECOMBIT reached the same conclusion. Whether a short targeted induction before immunotherapy could improve on either sequence is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02224781","url":"https://clinicaltrials.gov/study/NCT02224781"},{"label":"JCO 2023","url":"https://ascopubs.org/doi/10.1200/JCO.22.01763"}],"tags":[],"related":[],"cancers":["melanoma","braf-v600-melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["braf","pd1","ctla4"],"drugs":["nivolumab","ipilimumab","dabrafenib-trametinib"],"companies":["ecog-acrin"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02224781","phase":"3","setting":"Untreated BRAF V600 metastatic melanoma: nivolumab + ipilimumab then dabrafenib + trametinib at progression, vs the reverse sequence","sponsor":"ECOG-ACRIN / NCI","result":"2-year OS 71.8% vs 51.5%.","started":"2015-09-08","startedType":"actual","yearReported":2021,"enrolled":267,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 2 years","primary":true,"unit":"%","arms":[{"name":"Immunotherapy first","value":71.8},{"name":"Targeted therapy first","value":51.5}],"p":"0.010","source":"https://ascopubs.org/doi/10.1200/JCO.22.01763"}],"replication":"SECOMBIT (phase 2, Italy) independently favoured immunotherapy first."},{"id":"nct05709171","kind":"trial","name":"Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients With Neuroendocrine Neoplasms","aka":[],"tldr":"A phase 2 trial of Somatostatin receptor PET in Neuroendocrine tumours, run by Rigshospitalet, Denmark, with a status the registry has not verified recently.","summary":"Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients With Neuroendocrine Neoplasms is a phase 2 interventional study registered as NCT05709171 by Rigshospitalet, Denmark, with 200 participants planned, started 2023-01-17 and due to reach its primary completion in 2025-01-01. Interventions recorded: 18F-FDG, 64Cu-Dotatate. Conditions recorded: GEP-NET, Neuroendocrine Tumors, Neuroendocrine Carcinoma, Neuroendocrine Carcinoma Metastatic.\n\nLinked to the technology Somatostatin receptor PET because the registry names it (\"64cu dotatate\") among its interventions and Neuroendocrine tumours among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05709171","url":"https://clinicaltrials.gov/study/NCT05709171"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine"],"sections":[],"technologies":["sstr-pet"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05709171","phase":"2","setting":"Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients With Neuroendocrine Neoplasms","sponsor":"Rigshospitalet, Denmark","started":"2023-01-17","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07411599","kind":"trial","name":"Dual Administration Of Intraperitoneal And Intravenous TROP2-Directed CAR-NK With TGF-Beta Receptor 2 (TGFBR2) Knock Out (KO) Therapy For Colorectal Cancer-Rela","aka":[],"tldr":"A phase 1/2 trial of cyclophosphamide, fludarabine and cetuximab in colorectal cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"Dual Administration Of Intraperitoneal And Intravenous TROP2-Directed CAR-NK With TGF-Beta Receptor 2 (TGFBR2) Knock Out (KO) Therapy For Colorectal Cancer-Related Peritoneal Carcinomatosis: A Phase 1/2 Trial (\"Chip-CRC Trial\") is a phase 1/2, interventional study registered as NCT07411599 by M.D. Anderson Cancer Center, with a registry enrolment figure of 28 participants, started 2026-04-20 and due to reach its primary completion in 2028-11-15. Interventions recorded: Cyclophosphamide; Fludarabine; Cetuximab; NK Cells. Conditions listed: Colorectal Cancer; Peritoneal Metastases; Carcinomatosis. Primary outcome: Safety and adverse events (AEs. Colorectal eligibility wording from the registry: \"o History of hysterectomy or bilateral salpingo-oophorectomy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07411599","url":"https://clinicaltrials.gov/study/NCT07411599"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["cyclophosphamide","fludarabine","cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07411599","phase":"1/2","setting":"Dual Administration Of Intraperitoneal And Intravenous TROP2-Directed CAR-NK With TGF-Beta Receptor 2 (TGFBR2) Knock Out (KO) Therapy For Colorectal Cancer-Related Peritoneal Carcinomatosis: A Phase 1/2 Trial (\"Chip-CRC Trial\")","sponsor":"M.D. Anderson Cancer Center","started":"2026-04-20","startedType":"actual","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07059338","kind":"trial","name":"Dual EGFR/HER2 Blockade Combined With Irinotecan for the Treatment of HER2-Positive Metastatic Colorectal Cancer","aka":["HERBIC"],"tldr":"A phase 2 trial of trastuzumab, cetuximab and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"Dual EGFR/HER2 Blockade Combined With Irinotecan for the Treatment of HER2-Positive Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT07059338 by Sun Yat-sen University, with a registry enrolment figure of 34 participants, started 2025-07-11 and due to reach its primary completion in 2027-12-30. Interventions recorded: Trastuzumab +Cetuximab β+Irinotecan. Conditions listed: HER2 Positive; Colorectal Cancer (CRC). Primary outcome: 6-month progression-free-survival rates. Colorectal eligibility wording from the registry: \"* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with evidence of distant metastasis\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07059338","url":"https://clinicaltrials.gov/study/NCT07059338"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","her2-amplified-colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab","cetuximab","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07059338","phase":"2","setting":"Trastuzumab in Combination With Cetuximab and Irinotecan for the Treatment of HER2-Positive Metastatic Colorectal Cancer：A Phase II, Open-Label Trial","sponsor":"Sun Yat-sen University","started":"2025-07-11","startedType":"estimated","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07467863","kind":"trial","name":"Dual-Target CAR-NK Cells Directed Against MSLN, EGFR, or HER2 in Advanced NSCLC","aka":[],"tldr":"A phase 1/2 trial of Dual-target CAR-NK cells in non-small-cell lung cancer, run by Beijing Biotech, now recruiting.","summary":"Dual-Target CAR-NK Cells Directed Against MSLN, EGFR, or HER2 in Advanced NSCLC is a phase 1/2 interventional study registered as NCT07467863 by Beijing Biotech, with 48 participants planned, started 2026-02-02 and due to reach its primary completion in 2027-02-14. Interventions recorded: Dual-target CAR-NK cells and Lymphodepleting chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07467863","url":"https://clinicaltrials.gov/study/NCT07467863"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":["her2","egfr","mesothelin"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07467863","phase":"1/2","setting":"A Phase 1/2, Open-label, Biomarker-guided Study of Dual-target Chimeric Antigen Receptor Natural Killer (CAR-NK) Cells Targeting Mesothelin (MSLN) With EGFR or HER2/ERBB2, or EGFR With HER2/ERBB2, in Participants With Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC)","sponsor":"Beijing Biotech","started":"2026-02-02","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07486089","kind":"trial","name":"Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC)","aka":[],"tldr":"A phase 1/2 trial of Fludarabine in her2-positive breast cancer and triple-negative breast cancer, run by Beijing Biotech, now recruiting.","summary":"Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC) is a phase 1/2 interventional study registered as NCT07486089 by Beijing Biotech, with 60 participants planned, started 2026-02-02 and due to reach its primary completion in 2027-02-14. Interventions recorded: Dual-target CAR-NK cells (EB-DT-CAR-NK), Lymphodepleting chemotherapy, Supportive care. Conditions listed: Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer, Triple-Negative Breast Cancer (TNBC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07486089","url":"https://clinicaltrials.gov/study/NCT07486089"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","tnbc","tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fludarabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07486089","phase":"1/2","setting":"Phase 1/2, Biomarker-guided, Open-label Study of Allogeneic Dual-target CAR-NK Cells Directed Against HER2/ERBB2, MUC1, and/or ROR1 in Patients With Advanced or Metastatic Breast Cancer (Including HER2-positive and Triple-negative Disease).","sponsor":"Beijing Biotech","started":"2026-02-02","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07510802","kind":"trial","name":"Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC","aka":[],"tldr":"A phase 1/2 trial of Dual-target CAR-NK cells in HER2-positive breast cancer and triple-negative breast cancer, run by Beijing Biotech, now recruiting.","summary":"Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC is a phase 1/2 interventional study registered as NCT07510802 by Beijing Biotech, with 60 participants planned, started 2026-02-02 and due to reach its primary completion in 2027-03-14. Interventions recorded: Dual-target CAR-NK cells and Lymphodepleting.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07510802","url":"https://clinicaltrials.gov/study/NCT07510802"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":["her2","ror1"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07510802","phase":"1/2","setting":"Phase 1/2, Biomarker-guided, Open-label Study of Allogeneic Dual-target CAR-NK Cells Directed Against HER2/ERBB2, MUC1, and/or ROR1 in Patients With Advanced or Metastatic Breast Cancer (Including HER2-positive and Triple-negative Disease).","sponsor":"Beijing Biotech","started":"2026-02-02","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07462650","kind":"trial","name":"Dual-Target CAR-NK Cells for Biomarker-Selected Advanced Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of EB-DUO-CAR-NK-CEA/GCC (IV) in colorectal cancer, run by Beijing Biotech, now recruiting.","summary":"Dual-Target CAR-NK Cells for Biomarker-Selected Advanced Colorectal Cancer is a phase 1/2 interventional study registered as NCT07462650 by Beijing Biotech, with 48 participants planned, started 2026-02-01 and due to reach its primary completion in 2027-12-21. Interventions recorded: EB-DUO-CAR-NK-CEA/GCC (IV).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07462650","url":"https://clinicaltrials.gov/study/NCT07462650"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","her2-amplified-colorectal"],"sections":[],"technologies":[],"targets":["her2","ceacam5"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07462650","phase":"1/2","setting":"A Phase 1/2, Biomarker-Assigned, Open-Label Dose Escalation and Expansion Study of Allogeneic Dual-Target CAR-NK Cells Targeting CEA (CEACAM5) and/or GUCY2C (GCC) With an Exploratory HER2/ERBB2-Positive Cohort in Subjects With Advanced or Metastatic Colorectal Cancer","sponsor":"Beijing Biotech","started":"2026-02-01","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07589543","kind":"trial","name":"Dual-Target CAR-NK Cells in Recurrent or Refractory Epithelial Ovarian Cancer","aka":[],"tldr":"A phase 1/2 trial of Cyclophosphamide, Fludarabine in ovarian cancer, run by Beijing Biotech, now recruiting.","summary":"Dual-Target CAR-NK Cells in Recurrent or Refractory Epithelial Ovarian Cancer is a phase 1/2 interventional study registered as NCT07589543 by Beijing Biotech, with 42 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-03-14. Interventions recorded: EB-DUALNK, Cyclophosphamide, Fludarabine. Conditions listed: Epithelial Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07589543","url":"https://clinicaltrials.gov/study/NCT07589543"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["cyclophosphamide","fludarabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07589543","phase":"1/2","setting":"A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of Dual-Target CAR-NK Cells (EB-DUALNK) Following Lymphodepleting Chemotherapy in Adults With Recurrent or Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07627711","kind":"trial","name":"Dual-Target CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma","aka":[],"tldr":"A phase 1/2 trial of Fludarabine, Cyclophosphamide in pancreatic ductal adenocarcinoma, run by Beijing Biotech, now recruiting.","summary":"Dual-Target CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma is a phase 1/2 interventional study registered as NCT07627711 by Beijing Biotech, with 42 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-04-14. Interventions recorded: EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1), EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1), Lymphodepleting chemotherapy (Flu/Cy). Conditions listed: Pancreatic Ductal Adenocarcinoma (PDAC), Unresectable Locally Advanced, Metastatic Disease. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07627711","url":"https://clinicaltrials.gov/study/NCT07627711"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["fludarabine","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07627711","phase":"1/2","setting":"A Phase 1/2, Open-label, Biomarker-guided, Dose-escalation and Expansion Study of Dual-targeting CAR-NK Cells Directed Against Mesothelin (MSLN) and MUC1, With an Exploratory CLDN18.2/MUC1 Dual-target Cohort, in Patients With Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07641023","kind":"trial","name":"Dual-Target CAR-NK Cells Targeting MSLN, EGFR, or HER2 in Advanced NSCLC","aka":[],"tldr":"A phase 1/2 trial of Dual-target CAR-NK cells in non-small-cell lung cancer, run by Beijing Biotech, now recruiting.","summary":"Dual-Target CAR-NK Cells Targeting MSLN, EGFR, or HER2 in Advanced NSCLC is a phase 1/2 interventional study registered as NCT07641023 by Beijing Biotech, with 60 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-03-14. Interventions recorded: Dual-target CAR-NK cells and Lymphodepleting chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07641023","url":"https://clinicaltrials.gov/study/NCT07641023"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":["her2","egfr","mesothelin"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07641023","phase":"1/2","setting":"A Phase 1/2, Open-label, Biomarker-guided Study of Dual-target Chimeric Antigen Receptor Natural Killer (CAR-NK) Cells Targeting Mesothelin (MSLN) With EGFR or HER2/ERBB2, or EGFR With HER2/ERBB2, in Participants With Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC)","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07551349","kind":"trial","name":"Dual-target CD70/CAIX CAR-NK Cells for Advanced Clear Cell Renal Cell Carcinoma","aka":[],"tldr":"A phase 1/2 trial of Fludarabine in renal cell carcinoma, run by Beijing Biotech, now recruiting.","summary":"Dual-target CD70/CAIX CAR-NK Cells for Advanced Clear Cell Renal Cell Carcinoma is a phase 1/2 interventional study registered as NCT07551349 by Beijing Biotech, with 36 participants planned, started 2026-02-02 and due to reach its primary completion in 2027-04-14. Interventions recorded: EB-701/CA9-NK, Fludarabine. Conditions listed: Advanced or Metastatic Clear Cell Renal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07551349","url":"https://clinicaltrials.gov/study/NCT07551349"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc","clear-cell-rcc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fludarabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07551349","phase":"1/2","setting":"An Open-Label, Multicenter, Phase 1/2 Study of Allogeneic Dual-target CD70/CAIX (CA9) Chimeric Antigen Receptor Natural Killer Cells in Adults With Advanced or Metastatic Clear Cell Renal Cell Carcinoma","sponsor":"Beijing Biotech","started":"2026-02-02","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07551362","kind":"trial","name":"Dual-target CLDN18.2/HER2 CAR-NK Cells for Advanced Gastric/GEJ Cancer","aka":["DUET-GEJ"],"tldr":"A phase 1/2 trial of Fludarabine and Cyclophosphamide in gastric & gastro-oesophageal junction cancer, run by Beijing Biotech, now recruiting.","summary":"Dual-target CLDN18.2/HER2 CAR-NK Cells for Advanced Gastric/GEJ Cancer is a phase 1/2 interventional study registered as NCT07551362 by Beijing Biotech, with 36 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-03-14. Interventions recorded: EB-DT-CAR-NK, Fludarabine and Cyclophosphamide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07551362","url":"https://clinicaltrials.gov/study/NCT07551362"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fludarabine","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07551362","phase":"1/2","setting":"A Phase 1/2, Open-label, Multicenter Study of Allogeneic Dual-target CLDN18.2/HER2 (ERBB2) CAR-NK Cells After Fludarabine/Cyclophosphamide Lymphodepletion in","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07627698","kind":"trial","name":"Dual-Target CSPG4/GD2 CAR-NK Cells for Advanced Melanoma","aka":["DUET-MEL"],"tldr":"A phase 1/2 trial of Fludarabine, Cyclophosphamide in melanoma and uveal melanoma, run by Beijing Biotech, now recruiting.","summary":"Dual-Target CSPG4/GD2 CAR-NK Cells for Advanced Melanoma is a phase 1/2 interventional study registered as NCT07627698 by Beijing Biotech, with 36 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-06-14. Interventions recorded: EB-DTKN-401 allogeneic dual-target CSPG4/GD2 CAR-NK cells, Fludarabine, Cyclophosphamide. Conditions listed: Unresectable Melanoma, Metastatic Cutaneous Melanoma, Metastatic Uveal Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07627698","url":"https://clinicaltrials.gov/study/NCT07627698"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","uveal-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["fludarabine","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07627698","phase":"1/2","setting":"An Open-Label, Multicenter Phase 1/2 Study of Allogeneic Dual-Target CSPG4/GD2 CAR-NK Cells (EB-DTKN-401) in Adults With Unresectable or Metastatic Cutaneous Melanoma or Metastatic Uveal Melanoma","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07502287","kind":"trial","name":"Dual-Target GD2/B7-H3 CAR-NK Cells for Pediatric Relapsed or Refractory Neuroblastoma","aka":[],"tldr":"A phase 1/2 trial of Fludarabine and Cyclophosphamide in neuroblastoma, run by Beijing Biotech, now recruiting.","summary":"Dual-Target GD2/B7-H3 CAR-NK Cells for Pediatric Relapsed or Refractory Neuroblastoma is a phase 1/2 interventional study registered as NCT07502287 by Beijing Biotech, with 36 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-03-14. Interventions recorded: EB-DTNB-NK, Fludarabine and Cyclophosphamide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07502287","url":"https://clinicaltrials.gov/study/NCT07502287"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":["fludarabine","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07502287","phase":"1/2","setting":"A Phase 1/Phase 2, Open-Label Study of BiomarkerInformed, Allogeneic Dual-Target GD2/B7-H3 (CD276) CAR-NK Cells in Children and Young Adults With Relapsed or Refractory Neuroblastoma","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07500220","kind":"trial","name":"Dual-Target GPC3/B7-H3 CAR-NK Cells for Advanced HCC","aka":["DUET-HCC"],"tldr":"A phase 1/2 trial of Fludarabine, Cyclophosphamide in hepatocellular carcinoma, run by Beijing Biotech, now recruiting.","summary":"Dual-Target GPC3/B7-H3 CAR-NK Cells for Advanced HCC is a phase 1/2 interventional study registered as NCT07500220 by Beijing Biotech, with 30 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-03-14. Interventions recorded: EB-G3B7-NK dual-target CAR-NK cells, Fludarabine, Cyclophosphamide. Conditions listed: Advanced Hepatocellular Carcinoma (HCC), Metastatic Liver Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07500220","url":"https://clinicaltrials.gov/study/NCT07500220"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":["fludarabine","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07500220","phase":"1/2","setting":"A Phase 1/2, Open-Label, Dose-Escalation and Dose-Expansion Study of Allogeneic Dual-Target GPC3/B7-H3 (CD276) Chimeric Antigen Receptor Natural Killer Cells in Adults With Unresectable, Relapsed/Refractory, or Metastatic Hepatocellular Carcinoma","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07641036","kind":"trial","name":"Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer","aka":["DUET-BTC"],"tldr":"A phase 1/2 trial of Fludarabine, Cyclophosphamide in gallbladder cancer, run by Beijing Biotech, now recruiting.","summary":"Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer is a phase 1/2 interventional study registered as NCT07641036 by Beijing Biotech, with 30 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-03-14. Interventions recorded: EB-HC01 dual-target CARNK cells, Fludarabine, Cyclophosphamide. Conditions listed: Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Gallbladder Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07641036","url":"https://clinicaltrials.gov/study/NCT07641036"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gallbladder"],"sections":[],"technologies":[],"targets":[],"drugs":["fludarabine","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07641036","phase":"1/2","setting":"A Phase 1/2, Open-Label, Biomarker-Selected Study of Allogeneic Dual-Target HER2/CEACAM5 Chimeric Antigen Receptor Natural Killer Cells (EB-HC01) in Participants With Unresectable or Metastatic Cholangiocarcinoma and Other Biliary Tract Cancers","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07510815","kind":"trial","name":"Dual-Target MSLN/FAP CAR-NK Cells for Pleural and Peritoneal Mesothelioma","aka":[],"tldr":"A phase 1/2 trial of EB-MF-CAR-NK-01, Fludarabine, Cyclophosphamide in mesothelioma, run by Beijing Biotech, now recruiting.","summary":"Dual-Target MSLN/FAP CAR-NK Cells for Pleural and Peritoneal Mesothelioma is a phase 1/2 interventional study registered as NCT07510815 by Beijing Biotech, with 36 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-03-14. Interventions recorded: EB-MF-CAR-NK-01, Fludarabine, Cyclophosphamide. Conditions listed: Malignant Pleural Mesotheliomas. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07510815","url":"https://clinicaltrials.gov/study/NCT07510815"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mesothelioma","peritoneal-mesothelioma","pleural-mesothelioma"],"sections":[],"technologies":[],"targets":[],"drugs":["eb-mf-car-nk-01","fludarabine","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07510815","phase":"1/2","setting":"A Phase 1/2, Open-Label, Nonrandomized, Biomarker-Guided Study of Locoregional Allogeneic Dual-Target Mesothelin (MSLN) / Fibroblast Activation Protein (FAP) Chimeric Antigen Receptor Natural Killer Cells in Adults With Unresectable, Recurrent, or Refractory Pleural or Peritoneal Mesothelioma","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07480954","kind":"trial","name":"Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16)","aka":[],"tldr":"A phase 1/2 trial of Dual-target CAR-NK cell product in ovarian cancer, run by Beijing Biotech, now recruiting.","summary":"Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16) is a phase 1/2 interventional study registered as NCT07480954 by Beijing Biotech, with 36 participants planned, started 2026-02-04 and due to reach its primary completion in 2027-02-17. Interventions recorded: Dual-target CAR-NK cell product and Lymphodepleting chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07480954","url":"https://clinicaltrials.gov/study/NCT07480954"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer"],"sections":[],"technologies":[],"targets":["folr1","mesothelin","muc16"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07480954","phase":"1/2","setting":"A Phase 1/2, Open-Label, Biomarker-Assigned Study of Dual-Targeting CAR-NK Cells Directed Against Mesothelin (MSLN), Folate Receptor Alpha (FRα/FOLR1), and/or MUC16 (CA125) in Patients With Recurrent or Refractory High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","sponsor":"Beijing Biotech","started":"2026-02-04","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07617753","kind":"trial","name":"Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16) pt2","aka":[],"tldr":"A phase 1/2 trial of Cyclophosphamide in ovarian cancer, run by Beijing Biotech, now recruiting.","summary":"Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16) pt2 is a phase 1/2 interventional study registered as NCT07617753 by Beijing Biotech, with 36 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-06-14. Interventions recorded: Dual-target CAR-NK cell product, Cyclophosphamide, supportive. Conditions listed: Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Carcinoma, Recurrent or Refractory Disease After Standard Therapies. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07617753","url":"https://clinicaltrials.gov/study/NCT07617753"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07617753","phase":"1/2","setting":"A Phase 1/2, Open-Label, Biomarker-Assigned Study of Dual-Targeting CAR-NK Cells Directed Against Mesothelin (MSLN), Folate Receptor Alpha (FRα/FOLR1), and/or MUC16 (CA125) in Patients With Recurrent or Refractory High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07589517","kind":"trial","name":"Dual-Targeting CAR-NK Cells in Biomarker-Selected Advanced Colorectal Cancer","aka":["DUO-CRC-NK-111"],"tldr":"A phase 1/2 trial of EB-DUO-CAR-NK-CEA/GCC in colorectal cancer, run by Beijing Biotech, now recruiting.","summary":"Dual-Targeting CAR-NK Cells in Biomarker-Selected Advanced Colorectal Cancer is a phase 1/2 interventional study registered as NCT07589517 by Beijing Biotech, with 48 participants planned, started 2026-02-02 and due to reach its primary completion in 2027-03-14. Interventions recorded: EB-DUO-CAR-NK-CEA/GCC and Lymphodepletion.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07589517","url":"https://clinicaltrials.gov/study/NCT07589517"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","her2-amplified-colorectal"],"sections":[],"technologies":[],"targets":["her2","ceacam5"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07589517","phase":"1/2","setting":"A Phase 1/2, Biomarker-Assigned, Open-Label Dose Escalation and Expansion Study of Allogeneic Dual-Target CAR-NK Cells Targeting CEA (CEACAM5) and/or GUCY2C (GCC) With an Exploratory HER2/ERBB2-Positive Cohort in Subjects With Advanced or Metastatic Colorectal Cancer","sponsor":"Beijing Biotech","started":"2026-02-02","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07480928","kind":"trial","name":"Dual-Targeting CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma","aka":[],"tldr":"A phase 1/2 trial of Fludarabine, Cyclophosphamide in pancreatic ductal adenocarcinoma, run by Beijing Biotech, now recruiting.","summary":"Dual-Targeting CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma is a phase 1/2 interventional study registered as NCT07480928 by Beijing Biotech, with 42 participants planned, started 2026-02-02 and due to reach its primary completion in 2027-02-14. Interventions recorded: EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1), EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1), Lymphodepleting chemotherapy (Flu/Cy). Conditions listed: Pancreatic Ductal Adenocarcinoma (PDAC), Unresectable Locally Advanced or Metastatic Disease. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07480928","url":"https://clinicaltrials.gov/study/NCT07480928"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["fludarabine","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07480928","phase":"1/2","setting":"A Phase 1/2, Open-label, Biomarker-guided, Dose-escalation and Expansion Study of Dual-targeting CAR-NK Cells Directed Against Mesothelin (MSLN) and MUC1, With an Exploratory CLDN18.2/MUC1 Dual-target Cohort, in Patients With Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)","sponsor":"Beijing Biotech","started":"2026-02-02","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04137107","kind":"trial","name":"Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer","aka":[],"tldr":"A phase 2/3 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Alliance for Clinical Trials in Oncology, active but no longer recruiting.","summary":"Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer is a phase 2/3, randomised interventional study registered as NCT04137107 by Alliance for Clinical Trials in Oncology, with a registry enrolment figure of 220 participants, started 2020-06-17 and due to reach its primary completion in 2026-02-28. Interventions recorded: Oxaliplatin; Duloxetine Hydrochloride; Duloxetine; Quality-of-Life Assessment; Questionnaire Administration; Placebo. Conditions listed: Stage II Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8. Primary outcome: Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase II); Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase III); Chronic neuropathic pain response (Phase III). Colorectal eligibility wording from the registry: \"* Stage II-III colorectal cancer patients scheduled to receive oxaliplatin 510 mg/m\\^2 (cumulative dose) over 12 weeks as a component of adjuvant leucovorin calcium (calcium folinate), 5-fluorouracil and oxaliplatin (FOLFOX) treatment, in which patients are scheduled to receive oxaliplatin 85 mg/m\\^\". Sites: Guam, United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04137107","url":"https://clinicaltrials.gov/study/NCT04137107"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04137107","phase":"2/3","setting":"Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study","sponsor":"Alliance for Clinical Trials in Oncology","started":"2020-06-17","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"duo-e","kind":"trial","name":"DUO-E / GOG-3041 / ENGOT-EN10","aka":[],"tldr":"A third immunotherapy confirmed the benefit in dMMR disease and hinted that adding olaparib helps the mismatch-repair-proficient majority.","summary":"Durvalumab alone: PFS HR 0.71 overall and 0.42 in dMMR. Durvalumab + olaparib: PFS HR 0.55 overall and 0.57 in pMMR (JCO 2023). FDA approved durvalumab with chemotherapy for dMMR disease in June 2024; the EU approved both the durvalumab and durvalumab + olaparib regimens (pMMR for the latter) in 2024.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04269200","url":"https://clinicaltrials.gov/study/NCT04269200"},{"label":"JCO 2023","url":"https://ascopubs.org/doi/10.1200/JCO.23.02132"}],"tags":[],"related":[],"cancers":["endometrial","endometrial-mmr-deficient","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1","parp"],"drugs":["durvalumab","olaparib","carboplatin","paclitaxel"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["msi"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04269200","phase":"3","setting":"Newly diagnosed advanced or recurrent endometrial cancer: chemotherapy + durvalumab, then durvalumab ± olaparib maintenance, vs chemotherapy","sponsor":"AstraZeneca","result":"PFS HR 0.42 (dMMR, durvalumab); 0.57 (pMMR, durvalumab + olaparib).","started":"2020-05-05","startedType":"actual","yearReported":2023,"enrolled":718,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (dMMR, durvalumab)","unit":"HR","arms":[{"name":"Durvalumab + chemo"},{"name":"Chemo"}],"hr":0.42,"ci":[0.22,0.8],"source":"https://ascopubs.org/doi/10.1200/JCO.23.02132"},{"endpoint":"Progression-free survival (pMMR, durvalumab + olaparib)","unit":"HR","arms":[{"name":"Durvalumab + olaparib + chemo"},{"name":"Chemo"}],"hr":0.57,"ci":[0.44,0.73],"source":"https://ascopubs.org/doi/10.1200/JCO.23.02132"}]},{"id":"duo-o","kind":"trial","name":"DUO-O / ENGOT-ov46","aka":[],"tldr":"Adding immunotherapy and olaparib to bevacizumab slowed progression but has not improved survival, and the regimen is not approved.","summary":"DUO-O, also ENGOT-ov46, trial NCT03737643 sponsored by AstraZeneca and reported at ASCO 2023, tested adding durvalumab and olaparib to chemotherapy plus bevacizumab in newly diagnosed non-BRCA-mutated advanced ovarian cancer, and found that the combination slowed progression but has not improved survival, so the regimen is not approved. It randomised 1,130 patients, met its primary progression-free survival endpoint in the non-BRCA population for the durvalumab plus olaparib arm, but the interim overall survival analysis published in Annals of Oncology in 2025 showed no survival signal. Whether any subgroup of ovarian cancer benefits from first-line checkpoint blockade remains the open question.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03737643","url":"https://clinicaltrials.gov/study/NCT03737643"},{"label":"OncLive on OS","url":"https://www.onclive.com/view/chemotherapy-plus-durvalumab-bevacizumab-and-olaparib-fails-to-offer-os-benefit-in-newly-diagnosed-non-tbrca-mutated-ovarian-cancer"}],"tags":[],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1","parp"],"drugs":["durvalumab","olaparib","bevacizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03737643","phase":"3","setting":"Newly diagnosed non-BRCA-mutated advanced ovarian cancer: chemotherapy + bevacizumab + durvalumab, then durvalumab + bevacizumab ± olaparib maintenance, vs standard","sponsor":"AstraZeneca","result":"PFS HR 0.63; interim OS HR 0.95.","started":"2019-01-04","startedType":"actual","yearReported":2023,"enrolled":1130,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (non-tBRCAm ITT)","primary":true,"unit":"HR","arms":[{"name":"Durvalumab + olaparib + bevacizumab"},{"name":"Bevacizumab + placebo"}],"hr":0.63,"ci":[0.52,0.76],"source":"https://ascopubs.org/doi/10.1200/JCO.2023.41.17_suppl.LBA5506"}]},{"id":"nct03482102","kind":"trial","name":"Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of durvalumab and tremelimumab with radiotherapy in gallbladder cancer and other biliary tract cancers, run by Massachusetts General Hospital, active and no longer recruiting.","summary":"Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer is a phase 2 interventional study registered as NCT03482102 by Massachusetts General Hospital, with a registry enrolment figure of 37 participants, started 2018-05-14 and due to reach its primary completion in 2024-02-28. Interventions recorded: Tremelimumab, Durvalumab, Radiation. Conditions listed: Hepatocellular Carcinoma, Biliary Tract Cancer. Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03482102","url":"https://clinicaltrials.gov/study/NCT03482102"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03482102","phase":"2","setting":"A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer","sponsor":"Massachusetts General Hospital","started":"2018-05-14","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06992609","kind":"trial","name":"Durvalumab After Chemoradiotherapy in Limited Stage Small Cell Lung Cancer.","aka":["ALBORAN"],"tldr":"A phase 3 trial of Durvalumab in small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Durvalumab After Chemoradiotherapy in Limited Stage Small Cell Lung Cancer. is a phase 3 interventional study registered as NCT06992609 by AstraZeneca, with 68 participants enrolled, started 2025-09-15 and due to reach its primary completion in 2029-06-30. Interventions recorded: Durvalumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06992609","url":"https://clinicaltrials.gov/study/NCT06992609"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","limited-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06992609","phase":"3","setting":"A Phase IIIb Study of Durvalumab as Consolidation Treatment for Patients Diagnosed With Limited Stage Small Cell Lung Cancer Who Have Not Progressed Following Definitive Concurrent or Sequential Platinum-based Chemoradiation Therapy in Spain (ALBORAN).","sponsor":"AstraZeneca","started":"2025-09-15","startedType":"actual","enrolled":68,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04597671","kind":"trial","name":"Durvalumab and Low-dose PCI vs Durvalumab and Observation in Radically Treated Patients With Stage III NSCLC (NVALT28)","aka":["NVALT28"],"tldr":"A phase 3 trial of durvalumab in lung cancer, run by Association NVALT Studies, active but no longer recruiting.","summary":"Durvalumab and Low-dose PCI vs Durvalumab and Observation in Radically Treated Patients With Stage III NSCLC (NVALT28) is a phase 3, randomised interventional study registered as NCT04597671 by Association NVALT Studies, with a registry enrolment figure of 170 participants, started 2021-12-06 and due to reach its primary completion in 2028-12. Interventions recorded: Durvalumab; low-dose PCI. Conditions listed: Carcinoma, Non-Small-Cell Lung. Primary outcome: Reduction of incidence of brain metastases. Lung eligibility wording from the registry: \"TNM8 stage IIIA, IIIB or IIIC non-small cell lung cancer before start of concurrent chemoradiotherapy (preferentially histology; cytology is allowed)\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04597671","url":"https://clinicaltrials.gov/study/NCT04597671"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["durvalumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04597671","phase":"3","setting":"NVALT 28/ PRL01 Durvalumab and Low-dose Prophylactic Cranial Irradiation (PCI) Versus Durvalumab and Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer: A Phase III Randomized Study","sponsor":"Association NVALT Studies","started":"2021-12-06","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05883644","kind":"trial","name":"Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)","aka":["SIERRA"],"tldr":"A phase 3 trial of Durvalumab, Tremelimumab in hepatocellular carcinoma, run by AstraZeneca, active and no longer recruiting.","summary":"Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC) is a phase 3 interventional study registered as NCT05883644 by AstraZeneca, with 111 participants enrolled, started 2023-06-27 and due to reach its primary completion in 2026-03-30. Interventions recorded: Durvalumab, Tremelimumab. Conditions listed: Advanced Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05883644","url":"https://clinicaltrials.gov/study/NCT05883644"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05883644","phase":"3","setting":"A Phase IIIb Single Arm, Open-label, Multicentre Study of Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (SIERRA)","sponsor":"AstraZeneca","started":"2023-06-27","startedType":"actual","enrolled":111,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03837899","kind":"trial","name":"Durvalumab and Tremelimumab for Pediatric Malignancies","aka":[],"tldr":"A phase 1/2 trial of Durvalumab and Tremelimumab in childhood cancers, run by AstraZeneca, active and no longer recruiting.","summary":"Durvalumab and Tremelimumab for Pediatric Malignancies is a phase 1/2 interventional study registered as NCT03837899 by AstraZeneca, with 50 participants enrolled, started 2019-03-07 and due to reach its primary completion in 2023-02-28. Interventions recorded: Durvalumab / Tremelimumab Combination Therapy. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03837899","url":"https://clinicaltrials.gov/study/NCT03837899"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["childhood-cancers"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03837899","phase":"1/2","setting":"Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or in Combination With Tremelimumab in Pediatric Patients With Advanced Solid Tumors and Hematological Malignancies.","sponsor":"AstraZeneca","started":"2019-03-07","startedType":"actual","yearReported":2024,"enrolled":50,"enrolledBasis":"registry","outcomes":[{"endpoint":"Dose-Expansion Phase Only: Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg","n":11,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2024-03-19), not from a publication"},{"name":"STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg","n":9,"value":11.1}],"source":"https://clinicaltrials.gov/study/NCT03837899?tab=results"},{"endpoint":"Dose-Expansion Phase Only: Duration of Response (DOR)","primary":true,"unit":"months","arms":[{"name":"STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg","n":1,"value":10.8,"note":"range 10.8 to 10.8; Figures from the ClinicalTrials.gov results section (first posted 2024-03-19), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03837899?tab=results"},{"endpoint":"Dose-Expansion Phase Only: PFS","primary":true,"unit":"months","arms":[{"name":"SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg","n":11,"value":1.7,"note":"90% CI 1.58 to 1.91; Figures from the ClinicalTrials.gov results section (first posted 2024-03-19), not from a publication"},{"name":"STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg","n":10,"value":1.7,"note":"90% CI 0.89 to 2.76"}],"source":"https://clinicaltrials.gov/study/NCT03837899?tab=results"}]},{"id":"nct04499053","kind":"trial","name":"Durvalumab and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of durvalumab and tremelimumab in lung cancer, run by Georgetown University, now recruiting.","summary":"Durvalumab and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer is a phase 2, interventional study registered as NCT04499053 by Georgetown University, with a registry enrolment figure of 18 participants, started 2020-12-09 and due to reach its primary completion in 2027-02. Interventions recorded: Durvalumab; Tremelimumab. Conditions listed: Carcinoma, Non-Small Cell Lung. Primary outcome: Adverse Events; Radiological Response. Lung eligibility wording from the registry: \"Patients with stage IV NSCLC who had undergone no previous systemic therapy for stage IV disease\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04499053","url":"https://clinicaltrials.gov/study/NCT04499053"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04499053","phase":"2","setting":"A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer","sponsor":"Georgetown University","started":"2020-12-09","startedType":"actual","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05451043","kind":"trial","name":"Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)","aka":["BLOCKED"],"tldr":"A phase 2 trial of durvalumab, tremelimumab, gemcitabine and other drugs in gallbladder cancer and other biliary tract cancers, run by AHS Cancer Control Alberta, now recruiting.","summary":"Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED) is a phase 2 interventional study registered as NCT05451043 by AHS Cancer Control Alberta, with a registry enrolment figure of 62 participants, started 2023-07-05 and due to reach its primary completion in 2026-10-01. Interventions recorded: Durvalumab, Gemcitabine, Nab paclitaxel, Tremelimumab, Propranolol, Cisplatin. Conditions listed: Pancreatic Cancer, Hepatocellular Cancer, Biliary Tract Cancer, Cholangiocarcinoma. Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05451043","url":"https://clinicaltrials.gov/study/NCT05451043"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["durvalumab","tremelimumab","gemcitabine","cisplatin","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05451043","phase":"2","setting":"A Study to Evaluate the Efficacy of Propranolol in Boosting Immunotherapy in Hepatocellular Carcinoma, Cholangiocarcinoma and Pancreatic Adenocarcinoma","sponsor":"AHS Cancer Control Alberta","started":"2023-07-05","startedType":"actual","enrolled":62,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07081633","kind":"trial","name":"Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma","aka":["TREMENDOUS-2"],"tldr":"A phase 2 trial of Durvalumab, Tremelimumab, Lenvatinib in hepatocellular carcinoma, run by AstraZeneca, active and no longer recruiting.","summary":"Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma is a phase 2 interventional study registered as NCT07081633 by AstraZeneca, with 114 participants enrolled, started 2025-08-05 and due to reach its primary completion in 2026-11-30. Interventions recorded: Durvalumab, Tremelimumab, Lenvatinib. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07081633","url":"https://clinicaltrials.gov/study/NCT07081633"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["durvalumab","tremelimumab","lenvatinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07081633","phase":"2","setting":"An Open-label, Multi-center Phase II Study of Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma","sponsor":"AstraZeneca","started":"2025-08-05","startedType":"actual","enrolled":114,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05640791","kind":"trial","name":"Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of durvalumab, gemcitabine, cisplatin and nab-paclitaxel in gallbladder cancer and other biliary tract cancers, run by Tianjin Medical University Cancer Institute and Hospital, now recruiting.","summary":"Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer is a phase 2 interventional study registered as NCT05640791 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 40 participants, started 2023-01-12 and due to reach its primary completion in 2023-12-31. Interventions recorded: Cisplatin, Gemcitabine, Nab-paclitaxel, Durvalumab. Conditions listed: Resectable Biliary Tract Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05640791","url":"https://clinicaltrials.gov/study/NCT05640791"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["durvalumab","gemcitabine","cisplatin","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05640791","phase":"2","setting":"Phase II, Single-arm, Exploratory Study to Evaluate the Safety and Effectiveness of Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2023-01-12","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06490107","kind":"trial","name":"Durvalumab Combined With S-1 as Adjuvant Therapy of Resectable BTC","aka":[],"tldr":"A phase 2 trial of durvalumab and S-1 in gallbladder cancer and other biliary tract cancers, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, active and no longer recruiting.","summary":"Durvalumab Combined With S-1 as Adjuvant Therapy of Resectable BTC is a phase 2 interventional study registered as NCT06490107 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 40 participants, started 2024-05-24 and due to reach its primary completion in 2026-12-30. Interventions recorded: Durvalumab combined with S-1. Conditions listed: Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: \"2. Intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer(Histologically confirmed).\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06490107","url":"https://clinicaltrials.gov/study/NCT06490107"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["durvalumab","tegafur-gimeracil-oteracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06490107","phase":"2","setting":"A Single-arm, Single-center Study of Durvalumab Combined With S-1 as Adjuvant Therapy for Resectable Biliary Tract Cancer(BTC) With High Risk of Recurrence","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2024-05-24","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05557838","kind":"trial","name":"Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With uHCC","aka":["TREMENDOUS"],"tldr":"A phase 3 trial of Durvalumab, Tremelimumab in hepatocellular carcinoma, run by AstraZeneca, active and no longer recruiting.","summary":"Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With uHCC is a phase 3 interventional study registered as NCT05557838 by AstraZeneca, with 214 participants enrolled, started 2023-02-15 and due to reach its primary completion in 2026-09-30. Interventions recorded: Durvalumab, Tremelimumab. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05557838","url":"https://clinicaltrials.gov/study/NCT05557838"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05557838","phase":"3","setting":"An Open-label, Multi-center Phase IIIb Study of Durvalumab and Tremelimumab as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma","sponsor":"AstraZeneca","started":"2023-02-15","startedType":"actual","enrolled":214,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05771480","kind":"trial","name":"Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)","aka":["TOURMALINE"],"tldr":"A phase 3 trial of Durvalumab, Gemcitabine, Gemcitabine + cisplatin, Oxaliplatin, Carboplatin and Cisplatin in biliary tract cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs) is a phase 3 interventional study registered as NCT05771480 by AstraZeneca, with 142 participants enrolled, started 2023-08-16 and due to reach its primary completion in 2025-10-02. Interventions recorded: Durvalumab, Gemcitabine monotherapy, Gemcitabine + cisplatin, Gemcitabine + oxaliplatin, Gemcitabine + carboplatin and Gemcitabine + cisplatin + S-1.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05771480","url":"https://clinicaltrials.gov/study/NCT05771480"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","gemcitabine","gemcitabine-cisplatin","oxaliplatin","carboplatin","cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05771480","phase":"3","setting":"A Phase IIIb, Single Arm, Open-label, Multicentre Study of Durvalumab in Combination With Chemotherapy for the First Line Treatment for Patients With Advanced Biliary Tract Cancers (TOURMALINE)","sponsor":"AstraZeneca","started":"2023-08-16","startedType":"actual","enrolled":142,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03833154","kind":"trial","name":"Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation","aka":["PACIFIC-4"],"tldr":"A phase 3 trial of Durvalumab and Osimertinib in non-small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation is a phase 3 interventional study registered as NCT03833154 by AstraZeneca, with 724 participants enrolled, started 2019-03-06 and due to reach its primary completion in 2028-10-31. Interventions recorded: Durvalumab and (Osimertinib cohort, single-arm, open-label separate cohort).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03833154","url":"https://clinicaltrials.gov/study/NCT03833154"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["durvalumab","osimertinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03833154","phase":"3","setting":"A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib Following SBRT, a Single Arm Cohort for Patients With Unresected Stage I/II, Lymph Node Negative NSCLC Harboring a Sensitizing EGFR Mutation","sponsor":"AstraZeneca","started":"2019-03-06","startedType":"actual","enrolled":724,"enrolledBasis":"registry","outcomes":[]},{"id":"dutch-bone-metastasis-study","kind":"trial","name":"Dutch Bone Metastasis Study","aka":["DBMS","Single fraction versus multiple fraction radiotherapy for painful bone metastases"],"tldr":"One dose of radiotherapy relieves the pain of a bone secondary as well as six, which means one journey to hospital instead of six.","summary":"Painful bone metastases are common in lung cancer and radiotherapy relieves them in most patients. The question was whether a longer course works better. The Dutch Bone Metastasis Study randomised patients with painful bone metastases to a single 8 Gy fraction or 24 Gy in multiple fractions. The single-fraction arm had a much higher retreatment rate, 24 against 6 percent, which raised the suspicion that its apparent equivalence was an artefact of retreatment.\n\nThe 2004 reanalysis separated response to initial treatment from response to retreatment. Response to initial treatment was 71 percent after a single fraction against 73 percent after multiple fractions (p=0.84); allowing for retreatment raised the single-fraction figure to 75 percent while the multiple-fraction figure was unchanged (p=0.54). Response status after initial treatment did not predict who was retreated: 35 percent of single-fraction non-responders were retreated against 8 percent of multiple-fraction non-responders, and 22 against 10 percent of those with progressive pain. Randomisation arm and pain score before retreatment, not need, predicted retreatment, and retreatment worked in 63 percent of those who received it.\n\nThe practical conclusion is that a single 8 Gy fraction is the default for uncomplicated painful bone metastases, and that doctors, not the evidence, were the reason for the retreatment gap.","status":"positive","asOf":"2026-09-25","links":[{"label":"Dutch Bone Metastasis Study reanalysis (International Journal of Radiation Oncology, Biology, Physics 2004)","url":"https://doi.org/10.1016/j.ijrobp.2003.10.006"}],"tags":[],"related":[],"cancers":["nsclc","sclc","lung-cancer"],"sections":[],"technologies":["palliative-radiotherapy","hypofractionated-radiotherapy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["palliative-treatment","bone-metastases"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Painful bone metastases: a single 8 Gy fraction versus 24 Gy in multiple fractions, with pain response as the endpoint and retreatment permitted in both arms","sponsor":"Dutch Bone Metastasis Study Group","result":"Pain response to initial treatment 71 percent after a single 8 Gy fraction against 73 percent after 24 Gy in multiple fractions (p=0.84); retreatment raised the single-fraction figure to 75 percent.","yearReported":2004,"enrolled":1157,"enrolledBasis":"randomised","enrolledNote":"1,157 patients were randomised; the trial predates ClinicalTrials.gov registration.","outcomes":[{"endpoint":"Pain response to initial treatment","primary":true,"unit":"%","arms":[{"name":"8 Gy single fraction","value":71},{"name":"24 Gy in multiple fractions","value":73}],"p":"0.84","source":"https://doi.org/10.1016/j.ijrobp.2003.10.006"}],"replication":"Reproduced by multiple randomised trials and by the systematic reviews that followed; single-fraction treatment is the international standard for uncomplicated painful bone metastases."},{"id":"dutch-tme-trial","kind":"trial","name":"Dutch TME trial","aka":["CKVO 95-04"],"tldr":"The trial that proved a week of radiotherapy before rectal cancer surgery halves the chance of the cancer coming back in the pelvis, even when the operation is done properly.","summary":"The Dutch TME trial randomised 1,861 patients with resectable rectal cancer to 5 x 5 Gy preoperative radiotherapy followed by total mesorectal excision, or to total mesorectal excision alone, with surgical quality controlled by training and pathology review. Among the 1,748 who had a macroscopically complete local resection, local recurrence at two years was 2.4 percent with radiotherapy against 8.2 percent without. Two-year overall survival was the same (82.0 against 81.8 percent). The trial settled two questions at once: total mesorectal excision is the operation, and radiotherapy reduces local recurrence without lengthening life, so its use is a trade against long-term bowel and sexual function.","status":"positive","asOf":"2026-09-24","links":[{"label":"Dutch TME trial: preoperative radiotherapy combined with total mesorectal excision (New England Journal of Medicine 2001)","url":"https://doi.org/10.1056/NEJMoa010580"}],"tags":[],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":["stockholm-iii"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Resectable rectal cancer: short-course preoperative radiotherapy (5 x 5 Gy) plus total mesorectal excision against total mesorectal excision alone","sponsor":"Dutch Colorectal Cancer Group","result":"Local recurrence at two years 2.4 against 8.2 percent; no survival difference.","yearReported":2001,"enrolled":1861,"enrolledBasis":"randomised","enrolledNote":"1,861 patients were randomised and 1,805 were eligible; the trial predates ClinicalTrials.gov.","outcomes":[{"endpoint":"Local recurrence at 2 years","primary":true,"unit":"percent","arms":[{"name":"Radiotherapy plus TME","value":2.4},{"name":"TME alone","value":8.2}],"source":"https://doi.org/10.1056/NEJMoa010580"}]},{"id":"nct06221748","kind":"trial","name":"DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy","aka":[],"tldr":"A phase 2/3 trial of Disitamab vedotin and Cadonilimab in gastric & gastro-oesophageal junction cancer, run by RemeGen Co., Ltd., now recruiting.","summary":"DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy is a phase 2/3 interventional study registered as NCT06221748 by RemeGen Co., Ltd., with 90 participants planned, started 2024-02-22 and due to reach its primary completion in 2026-12. Interventions recorded: Disitamab Vedotin Injection, Cadonilimab Injection and Paclitaxel Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06221748","url":"https://clinicaltrials.gov/study/NCT06221748"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":["adc","bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["disitamab-vedotin","cadonilimab"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06221748","phase":"2/3","setting":"A Randomized，Multicenter, Open-Label，Phase II/III Study to Evaluate the Safety and Efficacy of Disitamab Vedotin Combined With Cadonilimab in Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma Who Have Progressed on r First-line Therapy","sponsor":"RemeGen Co., Ltd.","started":"2024-02-22","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06178159","kind":"trial","name":"DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer","aka":[],"tldr":"A phase 2 trial of Disitamab vedotin, Pertuzumab and Toripalimab in HER2-positive breast cancer, run by RemeGen Co., Ltd., now recruiting.","summary":"DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer is a phase 2 interventional study registered as NCT06178159 by RemeGen Co., Ltd., with 40 participants planned, started 2023-11-28 and due to reach its primary completion in 2026-06. Interventions recorded: Disitamab Vedotin Injection, Pertuzumab Injection and Toripalimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06178159","url":"https://clinicaltrials.gov/study/NCT06178159"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["disitamab-vedotin","pertuzumab","toripalimab"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06178159","phase":"2","setting":"A Phase II, Multicenter, Open-Label Neoadjuvant Study to Evaluate the Safety and Efficacy of Disitamab Vedotin in Combination With Pertuzumab With or Without Toripalimab for HER2 Positive Breast Cancer","sponsor":"RemeGen Co., Ltd.","started":"2023-11-28","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"dynamic","kind":"trial","name":"DYNAMIC","aka":[],"tldr":"Showed that a blood test can safely halve the number of colon cancer patients given chemotherapy after surgery.","summary":"DYNAMIC, registered as ACTRN12615000381583, sponsored by the Walter and Eliza Hall Institute and published in the New England Journal of Medicine in 2022, showed that a circulating tumour DNA blood test can safely halve the number of stage II colon cancer patients given chemotherapy after surgery. It randomised 455 patients to ctDNA-guided management or standard management, and chemotherapy use fell from 28 to 15 percent while two-year recurrence-free survival was non-inferior. DYNAMIC-III in stage III gave a more nuanced result, and whether escalating treatment in ctDNA-positive patients helps is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"NEJM 2022","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2200075"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["mrd","ctdna","de-escalation"],"trials":["dynamic-iii","altair","circulate-us","quasar"],"people":["jeanne-tie"],"bottlenecks":[],"keyPapers":["paper-tie-ctdna-minimal-residual-disease-stage-ii-colon-sci-transl-med-2016","paper-reinert-ctdna-ultradeep-sequencing-colorectal-jama-oncol-2019","paper-dynamic-nejm-2022","paper-dynamic-nat-med-2025-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"ACTRN12615000381583","phase":"2","setting":"Stage II colon cancer: ctDNA-guided adjuvant chemotherapy vs standard management","sponsor":"Walter and Eliza Hall Institute","result":"Chemotherapy use 15% vs 28% with non-inferior RFS.","yearReported":2022,"enrolled":455,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free survival at 2 years (non-inferiority)","primary":true,"unit":"%","arms":[{"name":"ctDNA-guided management","n":302,"value":93.5,"note":"Non-inferiority met (margin −8.5 points)"},{"name":"Standard management","n":153,"value":92.4}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2200075"},{"endpoint":"Patients receiving adjuvant chemotherapy","unit":"%","arms":[{"name":"ctDNA-guided management","value":15},{"name":"Standard management","value":28}],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2200075"}],"replication":"Supported by observational cohorts (CIRCULATE-Japan GALAXY); DYNAMIC-III in stage III gave a more nuanced result, and randomised escalation trials are ongoing."},{"id":"dynamic-iii","kind":"trial","name":"DYNAMIC-III","aka":[],"tldr":"The sequel to DYNAMIC asked whether a blood test should also decide chemotherapy in stage III disease. It could not prove that less is safe, and more did not help.","summary":"DYNAMIC-III randomised patients with stage III colon cancer 1:1 to ctDNA-guided or standard management after testing at five to six weeks. Of 968 evaluable patients, 702 (72.5 percent) were ctDNA-negative. At a median 47 months, ctDNA-negative patients recurred far less often than ctDNA-positive ones (three-year recurrence-free survival 87 against 49 percent, p<0.001), confirming the prognostic power of the test. But de-escalation in ctDNA-negative patients, while reducing oxaliplatin use from 88.6 to 34.8 percent and hospitalisations from 13.2 to 8.5 percent, gave slightly lower recurrence-free survival and did not meet non-inferiority; escalation in ctDNA-positive patients gave no benefit. With ALTAIR also negative, the position at September 2026 is that ctDNA tells you who will relapse and, outside stage II disease, does not yet tell you what to do about it.","status":"mixed","asOf":"2026-09-24","links":[{"label":"DYNAMIC-III: circulating tumour DNA-guided adjuvant therapy in locally advanced colon cancer (Nature Medicine 2025)","url":"https://doi.org/10.1038/s41591-025-04030-w"},{"label":"ANZCTR ACTRN12617001566325","url":"https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374135"}],"tags":[],"related":[],"cancers":["colorectal","colon-cancer"],"sections":[],"technologies":["mrd-testing","liquid-biopsy"],"targets":[],"drugs":["signatera","folfox","capox","oxaliplatin"],"companies":["agitg"],"institutions":[],"pathways":[],"terms":["mrd","ctdna","de-escalation"],"trials":["dynamic","altair","circulate-us"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ACTRN12617001566325","phase":"2/3","setting":"Stage III colon cancer: ctDNA tested 5 to 6 weeks after surgery, then de-escalated adjuvant therapy if negative and escalated if positive, against standard management","sponsor":"Walter and Eliza Hall Institute / Australasian Gastro-Intestinal Trials Group","result":"ctDNA is strongly prognostic (three-year recurrence-free survival 87 against 49 percent) but de-escalation was not non-inferior and escalation did not help.","yearReported":2025,"enrolled":968,"enrolledBasis":"analysed","enrolledNote":"968 evaluable patients; the trial is registered on the Australian New Zealand Clinical Trials Registry as ACTRN12617001566325 and has no NCT number.","outcomes":[{"endpoint":"Recurrence-free survival at 3 years by ctDNA status","primary":true,"unit":"percent","arms":[{"name":"ctDNA-negative","n":702,"value":87},{"name":"ctDNA-positive","n":266,"value":49}],"p":"<0.001","source":"https://doi.org/10.1038/s41591-025-04030-w"}],"replication":"DYNAMIC established de-escalation in stage II; DYNAMIC-III shows it does not carry over to stage III."},{"id":"nct07070440","kind":"trial","name":"DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7)","aka":["TIAN-SHAN7"],"tldr":"A phase 1/2 trial of Pemetrexed, Carboplatin, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by Dizal Pharmaceuticals, now recruiting.","summary":"DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7) is a phase 1/2 interventional study registered as NCT07070440 by Dizal Pharmaceuticals, with 180 participants planned, started 2025-07-16 and due to reach its primary completion in 2027-06. Interventions recorded: DZD6008, Pemetrexed, Carboplatin, Docetaxel. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07070440","url":"https://clinicaltrials.gov/study/NCT07070440"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pemetrexed","carboplatin","docetaxel"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07070440","phase":"1/2","setting":"A Phase 1/2, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7)","sponsor":"Dizal Pharmaceuticals","started":"2025-07-16","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07059650","kind":"trial","name":"DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12)","aka":["TAI-SHAN12"],"tldr":"A phase 1/2 trial of DZD8586 in diffuse large b-cell lymphoma, run by Dizal Pharmaceuticals, now recruiting.","summary":"DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12) is a phase 1/2 interventional study registered as NCT07059650 by Dizal Pharmaceuticals, with 150 participants planned, started 2025-08-19 and due to reach its primary completion in 2030-10. Interventions recorded: DZD8586+R-CHOP, DZD8586+R-GemOx, DZD8586+BR. Conditions listed: Diffuse Large B-Cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07059650","url":"https://clinicaltrials.gov/study/NCT07059650"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["dzd8586"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07059650","phase":"1/2","setting":"A Phase Ib/II, Multicenter Study to Evaluate the Efficacy and Safety of DZD8586 Combination Therapy in Diffuse Large B-cell Lymphoma","sponsor":"Dizal Pharmaceuticals","started":"2025-08-19","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06539182","kind":"trial","name":"DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)","aka":["TAI-SHAN8"],"tldr":"A phase 2 trial of DZD8586 in chronic lymphocytic leukaemia, run by Dizal Pharmaceuticals, now recruiting.","summary":"DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8) is a phase 2 interventional study registered as NCT06539182 by Dizal Pharmaceuticals, with 155 participants planned, started 2024-04-29 and due to reach its primary completion in 2027-09. Interventions recorded: DZD8586.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06539182","url":"https://clinicaltrials.gov/study/NCT06539182"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":[],"targets":[],"drugs":["dzd8586"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06539182","phase":"2","setting":"A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","sponsor":"Dizal Pharmaceuticals","started":"2024-04-29","startedType":"actual","enrolled":155,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06276283","kind":"trial","name":"DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)","aka":["WU-KONG29"],"tldr":"A phase 2 trial of Sunvozertinib and Bevacizumab in non-small-cell lung cancer, run by Dizal Pharmaceuticals, now recruiting.","summary":"DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29) is a phase 2 interventional study registered as NCT06276283 by Dizal Pharmaceuticals, with 60 participants planned, started 2023-02-15 and due to reach its primary completion in 2025-12-31. Interventions recorded: DZD9008 plus Bevacizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06276283","url":"https://clinicaltrials.gov/study/NCT06276283"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["sunvozertinib","bevacizumab"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06276283","phase":"2","setting":"A Phase II, Single Arm, Multicenter Study to Assess the Safety, Tolerability and Anti-Tumor Efficacy of DZD9008 With Bevacizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Mutations (WU-KONG29)","sponsor":"Dizal Pharmaceuticals","started":"2023-02-15","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"ea2197-ivonescimab","kind":"trial","name":"EA2197 ivonescimab: ivonescimab with gemcitabine and cisplatin versus standard chemo-immunotherapy in advanced biliary tract cancer","aka":[],"tldr":"A planned American cooperative-group trial will test whether the PD-1 and VEGF bispecific antibody ivonescimab beats the current immunotherapies when added to first-line chemotherapy for bile duct and gallbladder cancer, with survival as the endpoint.","summary":"This ECOG-ACRIN randomised phase 2/3 (NCT07765433) compares ivonescimab with gemcitabine and cisplatin against standard-of-care chemo-immunotherapy (gemcitabine and cisplatin with durvalumab or pembrolizumab) in patients with histologically or cytologically confirmed adenocarcinoma of the biliary tract, including intrahepatic and extrahepatic cholangiocarcinoma and gallbladder carcinoma, that is locally advanced or metastatic. The primary endpoint is overall survival; 336 patients are planned, with a start date of January 2027 and primary completion in December 2028. It is the first-line counterpart of the European SEVILLA trial and the first phase 3-scale test of a bispecific checkpoint antibody in biliary cancer against the TOPAZ-1 and KEYNOTE-966 standards.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07765433","url":"https://clinicaltrials.gov/study/NCT07765433"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":["pd1","vegf"],"drugs":["ivonescimab","gemcitabine-cisplatin","durvalumab","pembrolizumab"],"companies":["ecog-acrin"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07765433","phase":"2/3","setting":"First-line advanced biliary tract adenocarcinoma including unresectable or metastatic gallbladder adenocarcinoma: ivonescimab with gemcitabine and cisplatin versus gemcitabine and cisplatin with durvalumab or pembrolizumab, randomised phase 2/3, primary endpoint overall survival","sponsor":"ECOG-ACRIN Cancer Research Group","started":"2027-01-11","startedType":"estimated","enrolled":336,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01460589","kind":"trial","name":"Early Commencement of Adjuvant Chemotherapy for Colon Cancer","aka":["ECTX"],"tldr":"A phase 3 trial in colorectal cancer, run by Kyungpook National University Hospital, active but no longer recruiting.","summary":"Early Commencement of Adjuvant Chemotherapy for Colon Cancer is a phase 3, randomised interventional study registered as NCT01460589 by Kyungpook National University Hospital, with a registry enrolment figure of 303 participants, started 2013-01-13 and due to reach its primary completion in 2024-06-19. Interventions recorded: timing to initiate the adjuvant FOLFOX chemotherapy. Conditions listed: Colon Cancer. Primary outcome: 3-year disease free survival rate. Colorectal eligibility wording from the registry: \"* Rectal adenocarcinoma that were 15 cm or more from the anal verge\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01460589","url":"https://clinicaltrials.gov/study/NCT01460589"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01460589","phase":"3","setting":"Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Trial","sponsor":"Kyungpook National University Hospital","started":"2013-01-13","startedType":"actual","enrolled":303,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06926075","kind":"trial","name":"Early Phase Study of KESONOTIDE™in Participants With Solid Tumours","aka":["ADVICE"],"tldr":"A phase 1/2 trial of A novel hGIIA-Vimentin Inhibitor in prostate cancer, ovarian cancer, glioma & glioblastoma, pancreatic ductal adenocarcinoma and skin cancer, run by Filamon LTD, now recruiting.","summary":"Early Phase Study of KESONOTIDE™in Participants With Solid Tumours is a phase 1/2 interventional study registered as NCT06926075 by Filamon LTD, with 80 participants planned, started 2025-11-07 and due to reach its primary completion in 2027-10-26. Interventions recorded: A novel hGIIA-Vimentin Inhibitor and Dose expansion.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06926075","url":"https://clinicaltrials.gov/study/NCT06926075"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","ovarian","glioblastoma","pancreatic","skin-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06926075","phase":"1/2","setting":"An Adaptive Phase I/II Study of KESONOTIDE™, a Novel hGIIA-vimentin Inhibitor, in Participants With Solid Tumours","sponsor":"Filamon LTD","started":"2025-11-07","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04980716","kind":"trial","name":"Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Sun Yat-sen University, now recruiting.","summary":"Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients is a phase 3, randomised interventional study registered as NCT04980716 by Sun Yat-sen University, with a registry enrolment figure of 524 participants, started 2021-06-01 and due to reach its primary completion in 2026-01-31. Interventions recorded: Multiple cardiovascular drugs related to \"Golden Triangle\". Conditions listed: Non-small Cell Lung Cancer; Cardiovascular Complication. Primary outcome: Overall survival; The incidence of grade 2+ cardiotoxicity events. Lung eligibility wording from the registry: \"It is diagnosed as non-small cell lung cancer by pathological examination or cytological examination; it is assessed as locally advanced, unresectable stage III non-small cell lung cancer by imaging;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04980716","url":"https://clinicaltrials.gov/study/NCT04980716"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04980716","phase":"3","setting":"Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients Who Receiving Radical Concurrent Chemoradiotherapy and Immunotherapy: a Prospective, Randomized Controlled, Multicenter Phase III Clinical Trial.","sponsor":"Sun Yat-sen University","started":"2021-06-01","startedType":"actual","enrolled":524,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07455734","kind":"trial","name":"Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of BNT3214 in advanced solid tumours, run by BioNTech SE, now recruiting.","summary":"Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07455734 by BioNTech SE, with 533 participants planned, started 2026-03-30 and due to reach its primary completion in 2030-10. Interventions recorded: BNT3214.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07455734","url":"https://clinicaltrials.gov/study/NCT07455734"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07455734","phase":"1/2","setting":"A Phase I/IIa, First-in-human, Open-label, Multi-site, Multi-regional, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors","sponsor":"BioNTech SE","started":"2026-03-30","startedType":"actual","enrolled":533,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07410676","kind":"trial","name":"EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors","aka":["EBNK-ST-001"],"tldr":"A phase 1/2 trial of pembrolizumab in pancreatic cancer, run by Essen Biotech, now recruiting.","summary":"EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors is a phase 1/2, interventional study registered as NCT07410676 by Essen Biotech, with a registry enrolment figure of 83 participants, started 2026-02-01 and due to reach its primary completion in 2028-12-21. Interventions recorded: EBNK-001 + IL-15 + Pembrolizumab. Conditions listed: Cancer; Sarcoma; Leukaemia; Breast Cancer (Locally Advanced or Metastatic); Lung Cancer (Diagnosis); Colorectal Cancer; Melanoma (Skin Cancer); Bladder Cancer; Kidney Cancer; Pancreatic Cancer Metastatic; Liver Cancer (Primary and Metastatic); Ovarian Cancer; Esophageal Cancer; Glioblastoma; Non-Melanoma Skin Cancer. Primary outcome: Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs); Incidence of Dose-Limiting Toxicities (DLTs). Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07410676","url":"https://clinicaltrials.gov/study/NCT07410676"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07410676","phase":"1/2","setting":"An Open-Label Phase 1/2 Study of EBNK-001, an Allogeneic Natural Killer (NK) Cell Therapy Administered After Cyclophosphamide/Fludarabine Lymphodepletion With Low-Dose Interleukin-15, With or Without Pembrolizumab, in Participants With Advanced Solid Tumors","sponsor":"Essen Biotech","started":"2026-02-01","startedType":"actual","enrolled":83,"enrolledBasis":"registry","outcomes":[]},{"id":"echelon-1","kind":"trial","name":"ECHELON-1","aka":[],"tldr":"Swapping bleomycin for the CD30 ADC in first-line chemotherapy improved survival in advanced Hodgkin lymphoma, the first frontline survival gain in decades.","summary":"ECHELON-1, trial NCT01712490 sponsored by Seagen and Takeda and reported in 2017 with six-year survival in the New England Journal of Medicine in 2022, showed that swapping bleomycin for the CD30 antibody-drug conjugate brentuximab vedotin in first-line chemotherapy for advanced Hodgkin lymphoma improves survival, the first frontline survival gain in decades. It randomised 1,334 patients with stage III to IV disease to brentuximab plus AVD or ABVD, met its primary modified progression-free survival endpoint and later showed an overall survival benefit, with more neuropathy and neutropenia but less lung toxicity, leading to approval in March 2018. OnCo links it to Hodgkin lymphoma, ADCs, CD30 as a target, brentuximab vedotin, Joseph M. Connors, the bleomycin caution pairing and the ECHELON-1 and S1826 papers. Whether brentuximab keeps a frontline role after S1826 is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01712490","url":"https://clinicaltrials.gov/study/NCT01712490"}],"tags":[],"related":["lymphoma-roadmap","radar-hodgkin","hd21"],"cancers":["hodgkin-lymphoma","advanced-stage-classical-hodgkin-lymphoma"],"sections":[],"technologies":["adc"],"targets":["cd30"],"drugs":["brentuximab-vedotin","doxorubicin"],"companies":["pfizer","takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["joseph-connors"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01712490","phase":"3","setting":"Untreated stage III-IV classical Hodgkin lymphoma: brentuximab vedotin + AVD vs ABVD","sponsor":"Seagen / Takeda","result":"6-year OS 93.9% vs 89.4%, HR 0.59.","started":"2012-11-09","startedType":"actual","yearReported":2017,"enrolled":1334,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 6 years","unit":"%","arms":[{"name":"BV-AVD","n":664,"value":93.9},{"name":"ABVD","n":670,"value":89.4}],"hr":0.59,"ci":[0.4,0.88],"p":"0.009","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2206125"},{"endpoint":"Modified PFS at 2 years","primary":true,"unit":"%","arms":[{"name":"BV-AVD","value":82.1},{"name":"ABVD","value":77.2}],"hr":0.77,"ci":[0.6,0.98],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1708984"}],"replication":"SWOG S1826 used BV-AVD as its control and found nivolumab-AVD superior; ECHELON-1's OS benefit stands as the comparator."},{"id":"echelon-2","kind":"trial","name":"ECHELON-2","aka":[],"tldr":"ECHELON-2 was the first trial in decades to improve on CHOP chemotherapy for T-cell lymphoma: swapping vincristine for the antibody-drug conjugate brentuximab vedotin helped patients live longer, especially those with anaplastic large cell lymphoma.","summary":"ECHELON-2 randomised 452 patients with previously untreated CD30-positive peripheral T-cell lymphoma, about 70 percent of them with systemic anaplastic large cell lymphoma, to six to eight cycles of brentuximab vedotin plus cyclophosphamide, doxorubicin and prednisone (A+CHP) or to standard CHOP. The primary endpoint was progression-free survival by independent review.\n\nA+CHP lengthened progression-free survival and, unusually for a lymphoma trial, overall survival, with a similar rate of peripheral neuropathy to CHOP. It was approved in the United States in November 2018 for CD30-expressing peripheral T-cell lymphomas and is the standard front-line regimen for anaplastic large cell lymphoma; its benefit in the other CD30-positive histologies is less certain because they were a minority of the trial.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01777152","url":"https://clinicaltrials.gov/study/NCT01777152"}],"tags":["subtype-trials"],"related":["lymphoma-roadmap","jcog9801","smile-enktl","lymphoma-ev-randomised-evidence-for-the-t-cell-lymphomas"],"cancers":["peripheral-t-cell-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["brentuximab-vedotin","cyclophosphamide","doxorubicin","prednisone","vincristine"],"companies":["pfizer","takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["steven-horwitz"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01777152","phase":"3","setting":"Untreated CD30-positive peripheral T-cell lymphoma: brentuximab vedotin with cyclophosphamide, doxorubicin and prednisone (A+CHP) against CHOP","sponsor":"Seagen (Pfizer) with Takeda","result":"A+CHP improved progression-free and overall survival over CHOP in CD30-positive peripheral T-cell lymphoma; approved in November 2018.","started":"2013-01-31","startedType":"actual","yearReported":2018,"enrolled":452,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (blinded independent central review)","primary":true,"unit":"months","arms":[{"name":"A+CHP (brentuximab vedotin, cyclophosphamide, doxorubicin, prednisone)","n":226,"value":48.2},{"name":"CHOP","n":226,"value":20.8}],"hr":0.71,"ci":[0.54,0.93],"p":"0.0110","source":"https://doi.org/10.1016/s0140-6736(18)32984-2"},{"endpoint":"Febrile neutropenia","unit":"%","arms":[{"name":"A+CHP (brentuximab vedotin, cyclophosphamide, doxorubicin, prednisone)","n":226,"value":18},{"name":"CHOP","n":226,"value":15}],"source":"https://doi.org/10.1016/s0140-6736(18)32984-2"},{"endpoint":"Peripheral neuropathy","unit":"%","arms":[{"name":"A+CHP (brentuximab vedotin, cyclophosphamide, doxorubicin, prednisone)","n":226,"value":52},{"name":"CHOP","n":226,"value":55}],"source":"https://doi.org/10.1016/s0140-6736(18)32984-2"}]},{"id":"eclipse-psma","kind":"trial","name":"ECLIPSE","aka":[],"tldr":"Curium's PSMA radioligand met its progression endpoint; survival data and an FDA filing are pending.","summary":"ECLIPSE, trial NCT05204927 sponsored by Curium and reported in 2025, tested 177Lu-PSMA-I&T given as six cycles of 7.4 GBq against a switch of androgen receptor pathway inhibitor in PSMA-positive, taxane-naive metastatic castration-resistant prostate cancer after one such inhibitor. It enrolled 439 men and met its primary radiographic progression-free survival endpoint according to the sponsor, with medians pending publication, overall survival maturing, study completion projected for 2029 and an FDA submission plan under discussion. OnCo links it to prostate cancer and to the 177Lu-PSMA-I&T drug record; its result is consistent with PSMAfore for the pre-chemotherapy setting and contrasts with SPLASH, which used the same ligand but showed an unfavourable interim survival signal. Whether the survival data will support approval of a second lutetium PSMA agent is the open question.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT05204927","url":"https://clinicaltrials.gov/study/NCT05204927"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["radioligand-therapy"],"targets":[],"drugs":["lu177-psma-it"],"companies":["curium"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05204927","phase":"3","setting":"PSMA-positive mCRPC after ARPI, taxane-naive: 177Lu-PSMA-I&T (7.4 GBq × 6) vs ARPI switch","sponsor":"Curium","result":"rPFS significantly improved.","started":"2022-02-14","startedType":"actual","yearReported":2025,"enrolled":439,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic progression-free survival","primary":true,"unit":"months","arms":[{"name":"177Lu-PSMA-I&T","note":"Met per sponsor; medians pending publication"},{"name":"ARPI switch"}],"source":"https://clinicaltrials.gov/study/NCT05204927"}],"replication":"Consistent with PSMAfore for the pre-chemotherapy setting; OS pending."},{"id":"eclipse","kind":"trial","name":"ECLIPSE (GVAX pancreas and CRS-207)","aka":["ECLIPSE study","GVAX/CRS-207 phase 2b"],"tldr":"ECLIPSE was the randomised test of the Johns Hopkins pancreatic cancer vaccine strategy, a whole-cell GVAX vaccine followed by a Listeria vector carrying mesothelin; after promising early results it did not beat chemotherapy, with survival of 3.7 months against 4.6, and the programme ended.","summary":"ECLIPSE randomised 303 patients to cyclophosphamide with GVAX pancreas followed by CRS-207 (arm A), CRS-207 alone (arm B) or physician's choice single-agent chemotherapy (arm C). In the primary cohort of 213 patients who had failed two or more prior lines including gemcitabine, median overall survival was 3.7 months (95 percent confidence interval 2.9 to 5.3), 5.4 months (4.2 to 6.4) and 4.6 months (4.2 to 5.7) in arms A, B and C, with no difference between the vaccine combination and chemotherapy (hazard ratio 1.17, 0.84 to 1.64). Chills, pyrexia, fatigue and nausea were the commonest adverse events and there were no treatment-related deaths. The earlier phase 2 had reported 6.1 months with the combination against historical controls, a reminder that single-arm vaccine results in this disease have repeatedly failed to hold up when randomised, as ELI-002 7P did again in AMPLIFY-7P (2026); the personalised mRNA approach (autogene cevumeran) is now the vaccine strategy in randomised testing.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02004262","url":"https://clinicaltrials.gov/study/NCT02004262"},{"label":"Le et al., ECLIPSE (Clinical Cancer Research 2019)","url":"https://doi.org/10.1158/1078-0432.CCR-18-2992"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["shared-antigen-vaccine"],"targets":["mesothelin"],"drugs":["cyclophosphamide"],"companies":[],"institutions":["johns-hopkins"],"pathways":[],"terms":["cold-vs-hot","pancreatic-failed-programmes"],"trials":["amplify-7p","autogene-cevumeran-phase-1"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02004262","phase":"2","setting":"Previously treated metastatic pancreatic adenocarcinoma in the United States and Canada: cyclophosphamide with GVAX pancreas then CRS-207 (live attenuated Listeria expressing mesothelin), CRS-207 alone, or single-agent chemotherapy, randomised 1 to 1 to 1, with overall survival in patients after two or more prior lines as the primary endpoint","sponsor":"Aduro Biotech, with Johns Hopkins University","result":"Median overall survival 3.7 months with cyclophosphamide, GVAX pancreas and CRS-207 against 4.6 months with chemotherapy in the primary cohort (hazard ratio 1.17, 95 percent confidence interval 0.84 to 1.64); CRS-207 alone 5.4 months.","started":"2014-02-05","startedType":"actual","yearReported":2019,"enrolled":303,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, primary cohort (2 or more prior lines)","primary":true,"unit":"months","arms":[{"name":"Cyclophosphamide + GVAX pancreas then CRS-207","value":3.7,"note":"95% CI 2.9 to 5.3"},{"name":"CRS-207 alone","value":5.4,"note":"95% CI 4.2 to 6.4"},{"name":"Single-agent chemotherapy","value":4.6,"note":"95% CI 4.2 to 5.7"}],"hr":1.17,"ci":[0.84,1.64],"source":"https://doi.org/10.1158/1078-0432.CCR-18-2992"}]},{"id":"eclipse-shield","kind":"trial","name":"ECLIPSE (Shield blood test)","aka":[],"tldr":"The study behind the first approved blood test for bowel cancer screening: it found 83% of cancers but only 13% of advanced polyps.","summary":"Among 7,861 evaluable participants (NEJM 2024), the cfDNA blood test had 83.1% sensitivity for colorectal cancer, 13.2% sensitivity for advanced precancerous lesions, and 89.6% specificity for advanced neoplasia; sensitivity was 87.5% for stage I-III cancers. The FDA approved Shield on 26 July 2024 (PMA P230009) and Medicare covers it every three years. The low sensitivity for precancerous lesions means the test detects rather than prevents cancer, and guideline bodies rank it below colonoscopy, FIT and stool DNA.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT04136002","url":"https://clinicaltrials.gov/study/NCT04136002"},{"label":"ECLIPSE (NEJM 2024)","url":"https://doi.org/10.1056/NEJMoa2304714"},{"label":"FDA PMA P230009","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["colorectal-screening","liquid-biopsy"],"targets":[],"drugs":["shield"],"companies":["guardant-health"],"institutions":[],"pathways":[],"terms":["cfdna","sensitivity-specificity"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-eclipse-shield-n-engl-j-med-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04136002","phase":"observational","setting":"Prospective study of the Shield cell-free DNA blood test against screening colonoscopy in average-risk adults aged 45 to 84","sponsor":"Guardant Health","result":"Sensitivity 83.1% for colorectal cancer, 13.2% for advanced precancerous lesions; specificity 89.6%.","started":"2019-10-08","startedType":"actual","yearReported":2024,"enrolled":44467,"enrolledBasis":"registry","outcomes":[{"endpoint":"Sensitivity for colorectal cancer","primary":true,"unit":"%","arms":[{"name":"Shield cfDNA blood test","value":83.1}],"source":"https://doi.org/10.1056/NEJMoa2304714"},{"endpoint":"Specificity for advanced neoplasia","primary":true,"unit":"%","arms":[{"name":"Shield cfDNA blood test","value":89.6}],"source":"https://doi.org/10.1056/NEJMoa2304714"}]},{"id":"e1910","kind":"trial","name":"ECOG-ACRIN E1910","aka":[],"tldr":"Proved that adding the immunotherapy blinatumomab to standard treatment saves lives even in patients whose leukaemia was already undetectable.","summary":"224 MRD-negative patients randomised. 3-year OS 85% vs 68% (HR 0.41, 95% CI 0.23-0.73); relapse-free survival 80% vs 64%. NEJM 2024. Basis for the June 2024 FDA approval of blinatumomab in consolidation regardless of MRD status; changed frontline adult ALL worldwide. Benefit persisted across age and MRD sensitivity.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02003222","url":"https://clinicaltrials.gov/study/NCT02003222"},{"label":"NEJM 2024","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2312948"}],"tags":[],"related":[],"cancers":["all-leukemia","aya-cancers"],"sections":[],"technologies":["t-cell-engager"],"targets":["cd19","cd3"],"drugs":["blinatumomab"],"companies":["ecog-acrin"],"institutions":[],"pathways":[],"terms":["mrd-negative-cr"],"trials":[],"people":["mark-litzow"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02003222","phase":"3","setting":"Newly diagnosed Ph-negative B-ALL, age 30-70, in MRD-negative remission after induction: blinatumomab added to consolidation chemotherapy vs chemotherapy alone","sponsor":"ECOG-ACRIN / NCI","result":"3-year OS 85% vs 68%; HR 0.41.","started":"2014-05-19","startedType":"actual","yearReported":2024,"enrolled":488,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 3 years (MRD-negative cohort)","primary":true,"unit":"%","arms":[{"name":"Blinatumomab + chemotherapy","n":112,"value":85},{"name":"Chemotherapy","n":112,"value":68}],"hr":0.41,"ci":[0.23,0.73],"p":"0.002","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2312948"},{"endpoint":"Relapse-free survival at 3 years","unit":"%","arms":[{"name":"Blinatumomab + chemotherapy","value":80},{"name":"Chemotherapy","value":64}],"source":"https://doi.org/10.1056/NEJMoa2312948"}],"replication":"GMALL 08/2013 and the paediatric AALL1731 trial independently show blinatumomab improving outcomes when added to frontline therapy, in different age groups and risk strata."},{"id":"ecog-e3311","kind":"trial","name":"ECOG-ACRIN E3311","aka":[],"tldr":"E3311 showed that after robotic surgery for HPV-positive throat cancer, patients at intermediate risk could safely have a lower radiotherapy dose, with about 95 in 100 free of progression at two years, so surgery-first de-escalation became a recognised option.","summary":"E3311 enrolled 519 patients with HPV-positive oropharyngeal cancer suitable for transoral surgery. After resection and neck dissection they were assigned by pathology: low-risk patients had no further treatment, intermediate-risk patients were randomised to 50 Gy or the standard 60 Gy of radiotherapy, and high-risk patients (extranodal extension or positive margins) had 66 Gy with cisplatin.\n\nReported by Robert Ferris in the Journal of Clinical Oncology in 2022, two-year progression-free survival was 96.9 percent with observation, 94.9 percent with 50 Gy, 96.0 percent with 60 Gy and 90.7 percent in the high-risk chemoradiation arm. Swallowing scores were good and the reduced-dose arm had less toxicity. Transoral surgery was safe in experienced hands, with low rates of serious bleeding.\n\nThe trial, alongside the phase 2 PATHOS study in Britain, made surgery followed by pathology-guided reduced adjuvant treatment a standard route to de-escalation for HPV-positive disease, in contrast to the definitive chemoradiation setting where reduced doses failed in NRG-HN005.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01898494","url":"https://clinicaltrials.gov/study/NCT01898494"}],"tags":[],"related":[],"cancers":["oropharyngeal-cancer","hpv-positive-oropharyngeal-cancer"],"sections":[],"technologies":["tors","imrt-igrt"],"targets":[],"drugs":["cisplatin"],"companies":["ecog-acrin"],"institutions":[],"pathways":[],"terms":["hpv-p16","pfs"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01898494","phase":"2","setting":"Resectable HPV-positive oropharyngeal cancer: transoral surgery and neck dissection, then adjuvant treatment by pathological risk, with intermediate-risk patients randomised to 50 or 60 Gy of radiotherapy","sponsor":"ECOG-ACRIN Cancer Research Group","result":"Two-year progression-free survival 96.9% (observation), 94.9% (50 Gy), 96.0% (60 Gy) and 90.7% (high-risk chemoradiation).","started":"2014-01-22","startedType":"actual","yearReported":2022,"enrolled":519,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 2 years","primary":true,"unit":"%","arms":[{"name":"Low risk, observation","value":96.9},{"name":"Intermediate risk, 50 Gy","value":94.9},{"name":"Intermediate risk, 60 Gy","value":96},{"name":"High risk, 66 Gy + cisplatin","value":90.7}]}],"replication":"PATHOS (phase 2/3, United Kingdom) is testing the same design with swallowing and survival endpoints; the Mayo Clinic MC1273 series reported similar control with even lower postoperative doses."},{"id":"ea1131","kind":"trial","name":"ECOG-ACRIN EA1131","aka":["EA1131"],"tldr":"EA1131 asked whether platinum chemotherapy after surgery beats capecitabine for triple-negative breast cancer that survived pre-operative chemotherapy. It was stopped early because platinum was not going to prove better and was more toxic, so capecitabine stayed the standard.","summary":"ECOG-ACRIN EA1131 (NCT02445391) randomised 415 patients with stage II to III triple-negative breast cancer and residual invasive disease of at least 1 cm after neoadjuvant chemotherapy to four cycles of carboplatin or cisplatin or six cycles of capecitabine; the primary endpoint was three-year invasive disease-free survival in basal-like tumours (77 percent of enrolled patients by PAM50). The trial was closed early after a prespecified futility analysis found platinum unlikely to be superior or non-inferior to capecitabine (JCO 2021; the primary paper is not indexed on Europe PMC, so its hazard ratio is not quoted here). Patient-reported outcomes (Cancer 2024, 296 patients) showed a greater on-treatment symptom burden with capecitabine at cycle 3 despite a similar frequency of clinician-rated adverse events, and a clinically meaningful decline in neurotoxicity scores on platinum. A 2026 post hoc analysis (376 patients, 18 percent Black) found no racial difference in disease-free or overall survival despite worse socioeconomic indices among Black patients. EA1131 keeps capecitabine (CREATE-X) as the non-BRCA post-neoadjuvant standard and is the reason platinum is not offered in that setting.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02445391","url":"https://clinicaltrials.gov/study/NCT02445391"},{"label":"EA1131 patient-reported outcomes (Cancer 2024)","url":"https://doi.org/10.1002/cncr.35187"},{"label":"EA1131: race, socioeconomic status and outcomes (JCO Oncology Advances 2026)","url":"https://doi.org/10.1200/OA-25-00177"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["platinum","cytotoxic-chemotherapy"],"targets":[],"drugs":["carboplatin","cisplatin","capecitabine"],"companies":["ecog-acrin"],"institutions":["nci"],"pathways":[],"terms":["rcb","efs","tnbc-residual-disease-decision"],"trials":["create-x","keynote-522"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02445391","phase":"3","setting":"Stage II to III triple-negative breast cancer with residual invasive disease of 1 cm or more after neoadjuvant chemotherapy: adjuvant platinum (carboplatin or cisplatin, four cycles) versus capecitabine (six cycles), United States and South Africa","sponsor":"ECOG-ACRIN Cancer Research Group / National Cancer Institute","result":"Closed for futility: platinum not superior or non-inferior to capecitabine for iDFS in basal-like residual TNBC (primary hazard ratio not indexed).","started":"2015-10-20","startedType":"actual","yearReported":2021,"enrolled":415,"enrolledBasis":"registry","outcomes":[{"endpoint":"3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients","primary":true,"unit":"%","arms":[{"name":"Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)","n":148,"value":42,"note":"95% CI 30.5 to 53.1; Figures from the ClinicalTrials.gov results section (first posted 2022-10-05), not from a publication"},{"name":"Arm C (Capecitabine) (Open to Accrual 6/22/2016)","n":160,"value":49.4,"note":"95% CI 39.0 to 59.0"}],"hr":1.06,"ci":[0.62,1.81],"source":"https://clinicaltrials.gov/study/NCT02445391?tab=results"},{"endpoint":"3-year Overall Survival (OS) Rate in Basal-Subtype Patients","unit":"%","arms":[{"name":"Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)","n":148,"value":57.8,"note":"95% CI 45.2 to 68.4; Figures from the ClinicalTrials.gov results section (first posted 2022-10-05), not from a publication"},{"name":"Arm C (Capecitabine) (Open to Accrual 6/22/2016)","n":160,"value":66.2,"note":"95% CI 56.3 to 74.3"}],"source":"https://clinicaltrials.gov/study/NCT02445391?tab=results"}],"replication":"Consistent with CREATE-X's role for capecitabine; no trial has since tested platinum after residual disease."},{"id":"ef-14","kind":"trial","name":"EF-14","aka":[],"tldr":"The trial that made a wearable electric-field device part of glioblastoma care, extending median survival by about five months.","summary":"EF-14, trial NCT00916409 sponsored by Novocure and reported in 2015, made a wearable electric-field device part of glioblastoma care by extending median survival by about five months when added to maintenance temozolomide. It randomised 695 patients with newly diagnosed glioblastoma after chemoradiation, open-label, to tumour treating fields plus temozolomide or temozolomide alone, met its primary progression-free survival endpoint, improved overall survival and was stopped early for efficacy, with benefit correlating with hours of device use. OnCo links it to tumour treating fields, the Optune device record, temozolomide, Novocure, Roger Stupp and the brain as a bottleneck. The trial is debated for its lack of a sham control and has no independent randomised replication, so whether the effect is real or partly an artefact of design is the open question.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT00916409","url":"https://clinicaltrials.gov/study/NCT00916409"}],"tags":[],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["ttfields"],"targets":[],"drugs":["optune","temozolomide"],"companies":["novocure"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["roger-stupp"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00916409","phase":"3","setting":"Newly diagnosed glioblastoma after chemoradiation: TTFields + maintenance temozolomide vs temozolomide alone","sponsor":"Novocure","result":"OS 20.9 vs 16.0 months, HR 0.63.","started":"2009-06","yearReported":2015,"enrolled":695,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"TTFields + temozolomide","n":466,"value":6.7},{"name":"Temozolomide","n":229,"value":4}],"hr":0.63,"ci":[0.52,0.76],"p":"<0.001","source":"https://jamanetwork.com/journals/jama/fullarticle/2666504"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"TTFields + temozolomide","value":20.9},{"name":"Temozolomide","value":16}],"hr":0.63,"ci":[0.53,0.76],"source":"https://jamanetwork.com/journals/jama/fullarticle/2666504"}],"replication":"Single pivotal trial without a sham control; no independent randomised replication."},{"id":"nct06556563","kind":"trial","name":"EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma","aka":[],"tldr":"A phase 3 trial of Temozolomide and Pembrolizumab in glioma & glioblastoma, run by NovoCure GmbH, now recruiting.","summary":"EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma is a phase 3 interventional study registered as NCT06556563 by NovoCure GmbH, with 741 participants planned, started 2025-02-03 and due to reach its primary completion in 2029-04. Interventions recorded: Optune® device, Temozolomide, Pembrolizumab and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06556563","url":"https://clinicaltrials.gov/study/NCT06556563"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide","pembrolizumab"],"companies":["novocure","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06556563","phase":"3","setting":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant With Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant With Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58).","sponsor":"NovoCure GmbH","started":"2025-02-03","startedType":"actual","enrolled":741,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02813824","kind":"trial","name":"Effect of Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome","aka":["AAS-Lynch"],"tldr":"A phase 3 trial in colorectal cancer, run by Assistance Publique - Hôpitaux de Paris, active but no longer recruiting.","summary":"Effect of Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome is a phase 3, randomised interventional study registered as NCT02813824 by Assistance Publique - Hôpitaux de Paris, with a registry enrolment figure of 852 participants, started 2017-11-14 and due to reach its primary completion in 2026-06-15. Interventions recorded: Acetylsalicylic acid lysinate 300 mg; Placebo (for Aspirin 300); Acetylsalicylic acid lysinate 100 mg; Placebo 100 (for Aspirin 100). Conditions listed: Lynch Syndrome. Primary outcome: Number of patients with at least one adenoma seen on chromo-endoscopy 48 months after complete withdrawal of polyps and initiation of treatment (aspirin or placebo). Colorectal eligibility wording from the registry: \"* Aged more than 25 years, et aged more than 18 years with an early familial history and any reason to perform a colonoscopy every 2 years\". Sites: France. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02813824","url":"https://clinicaltrials.gov/study/NCT02813824"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02813824","phase":"3","setting":"Assessment of the Effect of a Daily Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome","sponsor":"Assistance Publique - Hôpitaux de Paris","started":"2017-11-14","startedType":"actual","enrolled":852,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07251582","kind":"trial","name":"Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer","aka":["LungTime-C02"],"tldr":"A phase 3 trial in lung cancer, run by Hunan Province Tumor Hospital, now recruiting.","summary":"Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT07251582 by Hunan Province Tumor Hospital, with a registry enrolment figure of 186 participants, started 2026-08-12 and due to reach its primary completion in 2028-10-31. Interventions recorded: Time of Day-based Assignment for Infusion of Immune Checkpoint Inhibitor (e.g., toripalimab, or pembrolizumab) + platinum-based chemotherapy. Conditions listed: Resectable Stage II-III Non-Small Cell Lung Cancer (NSCLC). Primary outcome: Pathological Complete Response (pCR) rate. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed diagnosis of resectable stage II to III non-small cell lung cancer (NSCLC)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07251582","url":"https://clinicaltrials.gov/study/NCT07251582"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07251582","phase":"3","setting":"A Prospective Study on the Effect of Infusion Timing of Immune Checkpoint Inhibitors on Pathologic Response in Patients With Resectable Stage II-III Non-Small Cell Lung Cancer Undergoing Neoadjuvant Therapy","sponsor":"Hunan Province Tumor Hospital","started":"2026-08-12","startedType":"estimated","enrolled":186,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04536675","kind":"trial","name":"Effect of Perioperative Bronchodilator in COPD Patients Undergoing Lung Cancer Surgery","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Samsung Medical Center, active but no longer recruiting.","summary":"Effect of Perioperative Bronchodilator in COPD Patients Undergoing Lung Cancer Surgery is a phase 3, randomised interventional study registered as NCT04536675 by Samsung Medical Center, with a registry enrolment figure of 204 participants, started 2021-04-01 and due to reach its primary completion in 2026-04-03. Interventions recorded: Vilanterol and Umeclidinium Bromide; Placebo. Conditions listed: Chronic Obstructive Pulmonary Disease; Non Small Cell Lung Cancer. Primary outcome: Difference in post-bronchodilator FEV1 between baseline and 16 weeks post-surgery. Lung eligibility wording from the registry: \"* Subjects of men or female over 40 years of age who are scheduled for curative pulmonary lobectomy due to confirmation (or high suspicion) of non-small cell lung cancer (NSCLC)\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04536675","url":"https://clinicaltrials.gov/study/NCT04536675"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04536675","phase":"3","setting":"Effect of Perioperative Fixed-dose Dual Bronchodilator Therapy on Post-operative Pulmonary Function Among Mild- to -Moderate COPD Patients Undergoing Lung Cancer Surgery","sponsor":"Samsung Medical Center","started":"2021-04-01","startedType":"actual","enrolled":204,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06923787","kind":"trial","name":"Effect of Perioperative Intravenous Infusion of Lidocaine on the Postoperative Course and the Immune Response in Patients Undergoing Surgery for Colon Cancer -","aka":["PILDI"],"tldr":"A phase 2 trial in colorectal cancer, run by Institute of Oncology Ljubljana, now recruiting.","summary":"Effect of Perioperative Intravenous Infusion of Lidocaine on the Postoperative Course and the Immune Response in Patients Undergoing Surgery for Colon Cancer - the PILDI Study is a phase 2, randomised interventional study registered as NCT06923787 by Institute of Oncology Ljubljana, with a registry enrolment figure of 100 participants, started 2026-02-03 and due to reach its primary completion in 2027-07-01. Interventions recorded: Lidocaine; Placebo. Conditions listed: Colon Cancer. Primary outcome: Difference in opioid use in 24 hours after surgery between arms. Colorectal eligibility wording from the registry: \"* colon cancer of any stage of the disease for which elective laparoscopic colon resection and colonic anastomosis will be performed,\". Sites: Slovenia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06923787","url":"https://clinicaltrials.gov/study/NCT06923787"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06923787","phase":"2","setting":"Effect of Perioperative Intravenous Infusion of Lidocaine on the Postoperative Course and the Immune Response in Patients Undergoing Surgery for Colon Cancer - the PILDI Study","sponsor":"Institute of Oncology Ljubljana","started":"2026-02-03","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07432399","kind":"trial","name":"Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study)","aka":["PILDI"],"tldr":"A phase 2 trial of dexamethasone in colorectal cancer, run by Institute of Oncology Ljubljana, now recruiting.","summary":"Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study) is a phase 2, randomised interventional study registered as NCT07432399 by Institute of Oncology Ljubljana, with a registry enrolment figure of 100 participants, started 2025-09-01 and due to reach its primary completion in 2027-05-01. Interventions recorded: Lidocaine; Dexamethasone; Placebo. Conditions listed: Colon Cancer; Colorectal Cancer; Perioperative Immune Response. Primary outcome: Change in Serum Cytokine Concentrations (IL-6, IL-8, IL-10, TNF-alpha). Colorectal eligibility wording from the registry: \"* Histologically confirmed colon cancer\". Sites: Slovenia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07432399","url":"https://clinicaltrials.gov/study/NCT07432399"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["dexamethasone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07432399","phase":"2","setting":"Effect of Perioperative Intravenous Infusion of Lidocaine or High Dose Dexamethasone on the Immune Response in Patients Undergoing Surgery for Colon Cancer - The PILDI Study","sponsor":"Institute of Oncology Ljubljana","started":"2025-09-01","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07473128","kind":"trial","name":"Effect of Trilaciclib in the Prevention of Myelosupression in Subjects With Limited-stage Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of Trilaciclib in small-cell lung cancer, run by Pharmacosmos A/S, now recruiting.","summary":"Effect of Trilaciclib in the Prevention of Myelosupression in Subjects With Limited-stage Small Cell Lung Cancer is a phase 3 interventional study registered as NCT07473128 by Pharmacosmos A/S, with 120 participants planned, started 2026-06-30 and due to reach its primary completion in 2027-06. Interventions recorded: Trilaciclib, Saline (0.9% NaCl). Conditions listed: Limited Stage Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07473128","url":"https://clinicaltrials.gov/study/NCT07473128"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","limited-stage-sclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["trilaciclib"],"companies":["pharmacosmos"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07473128","phase":"3","setting":"A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer","sponsor":"Pharmacosmos A/S","started":"2026-06-30","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01020448","kind":"trial","name":"Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer","aka":["Triptocare"],"tldr":"A phase 3 trial of Triptorelin in Prostate cancer, run by Ipsen, completed.","summary":"Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer is a phase 3 interventional study registered as NCT01020448 by Ipsen, with 339 participants recorded, started 2009-11 and reaching its primary completion in 2011-11. Interventions recorded: Triptorelin (Decapeptyl®). Conditions recorded: Prostate Cancer.\n\nLinked to the drug Triptorelin because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01020448","url":"https://clinicaltrials.gov/study/NCT01020448"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["triptorelin"],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01020448","phase":"3","setting":"Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study","sponsor":"Ipsen","started":"2009-11","enrolled":339,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07520578","kind":"trial","name":"EFFECTIVENESS OF EARLY INFORMATION AND ENDORSMENT BY GP TO INCREASE COLONOSCOPY FOLLOW-UP AND REDUCE DELAYS IN PEOPLE WITH A POSITIVE COLORECTAL CANCER SCREENIN","aka":["SUIVICOLO"],"tldr":"A phase 3 trial in colorectal cancer, run by University Hospital, Caen, now recruiting.","summary":"EFFECTIVENESS OF EARLY INFORMATION AND ENDORSMENT BY GP TO INCREASE COLONOSCOPY FOLLOW-UP AND REDUCE DELAYS IN PEOPLE WITH A POSITIVE COLORECTAL CANCER SCREENING TEST. (SUIVICOLO) is a phase 3, randomised interventional study registered as NCT07520578 by University Hospital, Caen, with a registry enrolment figure of 2000 participants, started 2026-03-24 and due to reach its primary completion in 2027-03-24. Interventions recorded: Usual care follow-up by CRCDC; Information leaflet about colonoscopy follow-up; Endorsement of CRCDC letters from the GP. Conditions listed: Colorectal Cancer Screening. Primary outcome: Colonoscopy rate at 6 months after a positive test. Colorectal eligibility wording from the registry: \"* Aged between 50 and 75 at the time of the positive colorectal cancer screening test\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07520578","url":"https://clinicaltrials.gov/study/NCT07520578"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07520578","phase":"3","setting":"EFFECTIVENESS OF EARLY INFORMATION AND ENDORSMENT BY GP TO INCREASE COLONOSCOPY FOLLOW-UP AND REDUCE DELAYS IN PEOPLE WITH A POSITIVE COLORECTAL CANCER SCREENING TEST, A RANDOMISED CONTROLLED TRIAL. (SUIVICOLO)","sponsor":"University Hospital, Caen","started":"2026-03-24","startedType":"actual","enrolled":2000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04099251","kind":"trial","name":"Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma","aka":["CheckMate 76K"],"tldr":"A phase 3 trial of Nivolumab in melanoma, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma is a phase 3 interventional study registered as NCT04099251 by Bristol-Myers Squibb, with 790 participants enrolled, started 2019-10-28 and due to reach its primary completion in 2022-06-28. Interventions recorded: Nivolumab, Placebo. Conditions listed: Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04099251","url":"https://clinicaltrials.gov/study/NCT04099251"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","stage-ii-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-checkmate-76k-nat-med-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04099251","phase":"3","setting":"A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma","sponsor":"Bristol-Myers Squibb","started":"2019-10-28","startedType":"actual","enrolled":790,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06230445","kind":"trial","name":"Effects of Digital Therapeutic in Whole Process Management of Lung Cancer","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Sun Yat-sen University, now recruiting.","summary":"Effects of Digital Therapeutic in Whole Process Management of Lung Cancer is a phase 3, randomised interventional study registered as NCT06230445 by Sun Yat-sen University, with a registry enrolment figure of 900 participants, started 2023-06-01 and due to reach its primary completion in 2026-03-01. Interventions recorded: UHealth digital therapeutic. Conditions listed: Application of Digital Therapeutic in Lung Cancer Whole Process Management. Primary outcome: The quality of life after 6 months follow-up. Lung eligibility wording from the registry: \"* Patients with histologically or cytologically confirmed lung cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06230445","url":"https://clinicaltrials.gov/study/NCT06230445"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06230445","phase":"3","setting":"A Phase 3, Randomized, Open-label Trial of Digital Therapeutic vs Regular Follow-up in Whole Process Management of Lung Cancer","sponsor":"Sun Yat-sen University","started":"2023-06-01","startedType":"actual","enrolled":900,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05220800","kind":"trial","name":"Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer","aka":["NAIDIC"],"tldr":"A phase 2 trial in colorectal cancer, run by Zealand University Hospital, not yet recruiting.","summary":"Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer is a phase 2, randomised interventional study registered as NCT05220800 by Zealand University Hospital, with a registry enrolment figure of 134 participants, started 2022-03-01 and due to reach its primary completion in 2024-03-01. Interventions recorded: Iron(III)isomaltoside; Placebo. Conditions listed: Iron-deficiency; Colorectal Cancer. Primary outcome: Change in oxygen uptake at the anaerobic threshold; Change in neutrophile to lymphocyte ratio (NLR); Changes in T-cell function - mRNA expression analysis. Colorectal eligibility wording from the registry: \"* Planned for curative intended elective colon or rectum cancer surgery\". Sites: Denmark. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05220800","url":"https://clinicaltrials.gov/study/NCT05220800"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05220800","phase":"2","setting":"Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer: A Double Blinded Clinical Randomized Trial","sponsor":"Zealand University Hospital","started":"2022-03-01","startedType":"estimated","enrolled":134,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05281471","kind":"trial","name":"Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)","aka":[],"tldr":"A phase 3 trial testing Olvimulogene nanivacirepvec in ovarian cancer, now recruiting.","summary":"Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076) is a phase 3 interventional study registered as NCT05281471, led by Genelux with GOG Foundation, and recruiting on the registry. Official title: A Randomised Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Physician's Choice of Chemotherapy and Bevacizumab in Women With Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076). Planned enrolment is 186 participants (estimated). The study started in 2022-08-31 and primary completion is expected in 2026-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05281471","url":"https://clinicaltrials.gov/study/NCT05281471"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["olvimulogene-nanivacirepvec"],"companies":["genelux"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05281471","phase":"3","setting":"A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Physician's Choice of Chemotherapy and Bevacizumab in Women With Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)","sponsor":"Genelux","started":"2022-08-31","startedType":"actual","enrolled":186,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06463665","kind":"trial","name":"Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL ","aka":["VIRO-25"],"tldr":"A phase 2 trial of Olvimulogene nanivacirepvec, Nivolumab, Cemiplimab in non-small-cell lung cancer and small-cell lung cancer, run by Genelux Corporation, now recruiting.","summary":"Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer is a phase 2 interventional study registered as NCT06463665 by Genelux Corporation, with 142 participants planned, started 2024-09-26 and due to reach its primary completion in 2027-02. Interventions recorded: Olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC, Physician's Choice of Immune Checkpoint Inhibitor: pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumab, Docetaxel. Conditions listed: Advanced Non-squamous Non-small-cell Lung Cancer, Advanced Squamous Non-Small Cell Lung Carcinoma, Metastatic Non-squamous Non Small Cell Lung Cancer, Metastatic Squamous Non-Small Cell Lung Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06463665","url":"https://clinicaltrials.gov/study/NCT06463665"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["olvimulogene-nanivacirepvec","nivolumab","cemiplimab","atezolizumab","durvalumab","docetaxel"],"companies":["genelux"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06463665","phase":"2","setting":"A Randomized Phase 2 Study Assessing the Efficacy and Safety of Olvimulogene Nanivacirepvec Followed by Platinum-doublet Chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor Compared With Docetaxel in Patients With NSCL Cancer After First Progression While on Front-line Immune Checkpoint Inhibitor-based Maintenance","sponsor":"Genelux Corporation","started":"2024-09-26","startedType":"actual","enrolled":142,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05055908","kind":"trial","name":"Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors","aka":["BECOME"],"tldr":"A phase 3 trial of pemetrexed and pembrolizumab in lung cancer, run by Hunan Province Tumor Hospital, now recruiting.","summary":"Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors is a phase 3, interventional study registered as NCT05055908 by Hunan Province Tumor Hospital, with a registry enrolment figure of 12000 participants, started 2021-10-01 and due to reach its primary completion in 2025-07-01. Interventions recorded: Pemetrexed plus Pembrolizumab; Pembrolizumab; Pemetrexed. Conditions listed: Lung Cancer. Primary outcome: Correlation between Adverse events (AEs) and gene profile. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed lung cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05055908","url":"https://clinicaltrials.gov/study/NCT05055908"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["pemetrexed","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05055908","phase":"3","setting":"Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors With or Without Chemotherapy","sponsor":"Hunan Province Tumor Hospital","started":"2021-10-01","startedType":"actual","enrolled":12000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04915755","kind":"trial","name":"Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease","aka":["ZEST"],"tldr":"A phase 3 trial of Niraparib in triple-negative breast cancer, run by GlaxoSmithKline, active and no longer recruiting.","summary":"Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease is a phase 3 interventional study registered as NCT04915755 by GlaxoSmithKline, with 40 participants enrolled, started 2021-06-28 and due to reach its primary completion in 2024-06-28. Interventions recorded: Niraparib and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04915755","url":"https://clinicaltrials.gov/study/NCT04915755"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["parp-inhibitor","mrd-testing"],"targets":[],"drugs":["niraparib"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":["ctdna","gbrca-mutation","tnbc-residual-disease-decision"],"trials":["c-trak-tn","bre12-158","olympia"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["ZEST (NCT04915755, GlaxoSmithKline): randomised double-blind phase 3 of niraparib versus placebo for HER2-negative BRCA-mutated or triple-negative breast cancer with ctDNA detected after definitive therapy; the registry records only 40 participants randomised (actual) against the design, primary completion June 2024 and results posted July 2025 as safety outcomes, because too few screened patients were ctDNA-positive and free of recurrence at detection, the same problem c-TRAK TN met in the UK. Twelve UK sites (Bath, Brighton, Cardiff, Coventry, Edinburgh, Leeds, London, Maidstone, Manchester, Sutton, Wigan) took part."],"nct":"NCT04915755","phase":"3","setting":"A Randomized Phase 3 Double-Blinded Study Comparing the Efficacy and Safety of Niraparib to Placebo in Participants With Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer With Molecular Disease Based on Presence of Circulating Tumor DNA After Definitive Therapy (ZEST)","sponsor":"GlaxoSmithKline","started":"2021-06-28","startedType":"actual","yearReported":2025,"enrolled":40,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With TEAEs Leading to Death","primary":true,"unit":"participants","arms":[{"name":"Niraparib","n":18,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2025-07-16), not from a publication"},{"name":"Placebo","n":22,"value":0}],"source":"https://clinicaltrials.gov/study/NCT04915755?tab=results"}]},{"id":"nct07505472","kind":"trial","name":"Efficacy and Safety Comparison of Short-course Radiotherapy Followed by CapeOX Chemotherapy Plus Toripalimab With or Without Concurrent Surufatinib in Neoadjuva","aka":["STARS-RC10"],"tldr":"A phase 2/3 trial in colorectal cancer, run by The First Hospital of Jilin University, now recruiting.","summary":"Efficacy and Safety Comparison of Short-course Radiotherapy Followed by CapeOX Chemotherapy Plus Toripalimab With or Without Concurrent Surufatinib in Neoadjuvant Therapy for Mid-to-low Localized Rectal Cancer of High-risk Criteria is a phase 2/3, interventional study registered as NCT07505472 by The First Hospital of Jilin University, with a registry enrolment figure of 212 participants, started 2026-02-23 and due to reach its primary completion in 2029-12-31. Interventions recorded: Experimental Group; Control group. Conditions listed: Rectal Cancer. Primary outcome: pathologic complete response，pCR. Colorectal eligibility wording from the registry: \"Pathologically confirmed rectal tubular adenocarcinoma; Differentiation into Grade 1-3, i\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07505472","url":"https://clinicaltrials.gov/study/NCT07505472"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07505472","phase":"2/3","setting":"Efficacy and Safety Comparison of Short-course Radiotherapy Followed by CapeOX Chemotherapy Plus Toripalimab With or Without Concurrent Surufatinib in Neoadjuvant Therapy for Mid-to-low Localized Rectal Cancer of High-risk Criteria","sponsor":"The First Hospital of Jilin University","started":"2026-02-23","startedType":"actual","enrolled":212,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02697734","kind":"trial","name":"Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease","aka":[],"tldr":"A phase 3 trial of Osilodrostat in Pituitary tumours, run by Novartis Pharmaceuticals, completed.","summary":"Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease is a phase 3 interventional study registered as NCT02697734 by Novartis Pharmaceuticals, with 73 participants recorded, started 2016-10-03 and reaching its primary completion in 2019-06-19. Interventions recorded: osilodrostat, osilodrostat Placebo. Conditions recorded: Cushing's Disease.\n\nLinked to the drug Osilodrostat because the registry names it among its interventions and Pituitary tumours among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02697734","url":"https://clinicaltrials.gov/study/NCT02697734"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pituitary-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["osilodrostat"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02697734","phase":"3","setting":"A Phase III, Multi-center, Randomized, Double-blind, 48 Week Study With an Initial 12 Week Placebo-controlled Period to Evaluate the Safety and Efficacy of Osilodrostat in Patients With Cushing's Disease","sponsor":"Novartis Pharmaceuticals","started":"2016-10-03","startedType":"actual","yearReported":2021,"enrolled":73,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Randomized Participants With a Complete Response","primary":true,"unit":"participants","arms":[{"name":"Osilodrostat Group","n":48,"value":37,"note":"Figures from the ClinicalTrials.gov results section (first posted 2021-10-19), not from a publication"},{"name":"Osilodrostat Placebo Group","n":25,"value":2}],"p":"<.0001","source":"https://clinicaltrials.gov/study/NCT02697734?tab=results"}]},{"id":"nct06281964","kind":"trial","name":"Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion.","aka":["KANNON-2"],"tldr":"A phase 3 trial of pemetrexed in lung cancer, run by Avistone Biotechnology Co., Ltd., now recruiting.","summary":"Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion. is a phase 3, randomised interventional study registered as NCT06281964 by Avistone Biotechnology Co., Ltd., with a registry enrolment figure of 327 participants, started 2023-12-01 and due to reach its primary completion in 2028-06-30. Interventions recorded: PLB1004; Pemetrexed+（carboplatin or Cisplatin）with or without Sintilimab. Conditions listed: Non-Small-Cell Lung Cancer. Primary outcome: Progression-Free Survival (PFS) by BICR. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\\~IV)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06281964","url":"https://clinicaltrials.gov/study/NCT06281964"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["pemetrexed"],"companies":["avistone-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06281964","phase":"3","setting":"Randomized, Controlled, Open Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of PLB1004 Versus Platinum-based Chemotherapy With or Without Sintilimab of Advanced NSCLC With EGFR Exon 20 Ins Mutations","sponsor":"Avistone Biotechnology Co., Ltd.","started":"2023-12-01","startedType":"actual","enrolled":327,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06959082","kind":"trial","name":"Efficacy and Safety Evaluation of VS-101 in Combination With Chemoradiotherapy in Patients With Head and Neck Cancer","aka":[],"tldr":"A phase 2 trial of Cisplatin in head and neck squamous cell carcinoma, run by VSPharmTech Co.,Ltd., now recruiting.","summary":"Efficacy and Safety Evaluation of VS-101 in Combination With Chemoradiotherapy in Patients With Head and Neck Cancer is a phase 2 interventional study registered as NCT06959082 by VSPharmTech Co.,Ltd., with 30 participants planned, started 2025-06-11 and due to reach its primary completion in 2027-12. Interventions recorded: VS-101, Cisplatin and Radiation.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06959082","url":"https://clinicaltrials.gov/study/NCT06959082"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06959082","phase":"2","setting":"A Multi-center, Randomized, Open-label, Parallel-group, Phase 2 Study to Evaluate the Efficacy and Safety of VS-101 in Combination With Chemoradiotherapy (CRT) in Patients With Head and Neck Cancer","sponsor":"VSPharmTech Co.,Ltd.","started":"2025-06-11","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07276789","kind":"trial","name":"Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Patients Undergoing Lung Cancer Resection for Non Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of LS301-IT 0.1 mg/kg in non-small-cell lung cancer, run by Integro Theranostics, now recruiting.","summary":"Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Patients Undergoing Lung Cancer Resection for Non Small Cell Lung Cancer is a phase 2 interventional study registered as NCT07276789 by Integro Theranostics, with 35 participants planned, started 2025-12-08 and due to reach its primary completion in 2026-08. Interventions recorded: LS301-IT 0.1 mg/kg.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07276789","url":"https://clinicaltrials.gov/study/NCT07276789"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07276789","phase":"2","setting":"A Phase 2, Open-Label, Multicenter Study to Investigate the Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Lung Cancer Resection","sponsor":"Integro Theranostics","started":"2025-12-08","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05304481","kind":"trial","name":"Efficacy and Safety of Activated T Lymphocytes (ATL) in Hepatocellular Carcinoma","aka":[],"tldr":"A phase 2 trial of ATL administration in hepatocellular carcinoma, run by Lukas Biomedical Inc., now recruiting.","summary":"Efficacy and Safety of Activated T Lymphocytes (ATL) in Hepatocellular Carcinoma is a phase 2 interventional study registered as NCT05304481 by Lukas Biomedical Inc., with 95 participants planned, started 2022-05-14 and due to reach its primary completion in 2027-12-31. Interventions recorded: ATL administration.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05304481","url":"https://clinicaltrials.gov/study/NCT05304481"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05304481","phase":"2","setting":"A Phase II Study to Evaluate the Efficacy and Safety of Activated T Lymphocytes (ATL) in Hepatocellular Carcinoma (HCC) Patients After Curative Treatment","sponsor":"Lukas Biomedical Inc.","started":"2022-05-14","startedType":"actual","enrolled":95,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07253896","kind":"trial","name":"Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab is a phase 2, interventional study registered as NCT07253896 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 40 participants, started 2024-01-03 and due to reach its primary completion in 2026-01-03. Interventions recorded: AK104 and cetuximab or bevacizumab and FOLFIRI. Conditions listed: Safety. Primary outcome: objective response rate. Colorectal eligibility wording from the registry: \"Metastatic colorectal adenocarcinoma confirmed by histology or cytology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07253896","url":"https://clinicaltrials.gov/study/NCT07253896"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07253896","phase":"2","setting":"Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab as Second-line Treatment in MSS Type Metastatic Colorectal Cancer Based on RAS Gene Status","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2024-01-03","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04762459","kind":"trial","name":"Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for Stage II-IIIA Non-small Cell Lung Carcinoma Following Com","aka":["APEX"],"tldr":"A phase 3 trial of aumolertinib, pemetrexed and cisplatin in lung cancer, run by Chinese Academy of Medical Sciences, now recruiting.","summary":"Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection is a phase 3, randomised interventional study registered as NCT04762459 by Chinese Academy of Medical Sciences, with a registry enrolment figure of 606 participants, started 2021-08-01 and due to reach its primary completion in 2026-05. Interventions recorded: Almonertinib; Pemetrexed; Cisplatin. Conditions listed: Non-small Cell Lung Carcinoma. Primary outcome: Disease free survival (DFS). Lung eligibility wording from the registry: \"Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04762459","url":"https://clinicaltrials.gov/study/NCT04762459"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","platinum"],"targets":[],"drugs":["aumolertinib","pemetrexed","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04762459","phase":"3","setting":"Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for EGFR Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection: A Multicenter, Randomized Controlled, Open-label Clinical Study","sponsor":"Chinese Academy of Medical Sciences","started":"2021-08-01","startedType":"actual","enrolled":606,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06282445","kind":"trial","name":"Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsate","aka":[],"tldr":"A phase 2 trial of adebrelimab, fOLFOX (5-FU, leucovorin, oxaliplatin), capecitabine and bevacizumab (glioblastoma use) in colorectal cancer, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine, now recruiting.","summary":"Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06282445 by The Fourth Affiliated Hospital of Zhejiang University School of Medicine, with a registry enrolment figure of 36 participants, started 2024-03-01 and due to reach its primary completion in 2025-03-01. Interventions recorded: Adebrelimab; Oxaliplatin; Capecitabine; Bevacizumab. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Progression-free survival. Colorectal eligibility wording from the registry: \"Metastatic colorectal cancer confirmed histologically and/or cytologically and initially unresectable\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06282445","url":"https://clinicaltrials.gov/study/NCT06282445"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["adebrelimab","folfox","capecitabine","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06282445","phase":"2","setting":"Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer: a Prospective, Multicenter, Single-arm Study","sponsor":"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","started":"2024-03-01","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06176885","kind":"trial","name":"Efficacy and Safety of Combined With Immunotherapy After Induction Therapy With Chemotherapy and Targeted Therapy in the First-line Treatment of Microsatellite","aka":["FOBECAMS"],"tldr":"A phase 2 trial of camrelizumab in colorectal cancer, run by yue junhan, now recruiting.","summary":"Efficacy and Safety of Combined With Immunotherapy After Induction Therapy With Chemotherapy and Targeted Therapy in the First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06176885 by yue junhan, with a registry enrolment figure of 36 participants, started 2023-12-20 and due to reach its primary completion in 2025-12-20. Interventions recorded: Camrelizumab. Conditions listed: Colorectal Cancer. Primary outcome: PFS（Disease-free Survival）. Colorectal eligibility wording from the registry: \"Metastatic colorectal cancer confirmed by histology and/or cytology and initially unresectable\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06176885","url":"https://clinicaltrials.gov/study/NCT06176885"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["camrelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06176885","phase":"2","setting":"Efficacy and Safety of Camrelizumab Combined With Irinotecan, Leucovorin and Fluorouracil (FOLFIRI) Chemotherapy and Bevacizumab Targeted Induction Therapy in the First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer: a Prospective, Multicenter, Single-arm Study","sponsor":"yue junhan","started":"2023-12-20","startedType":"estimated","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04465968","kind":"trial","name":"Efficacy and Safety of CRT, Durvalumab and Surgery for SST","aka":["DEEP_OCEAN"],"tldr":"A phase 3 trial of cisplatin and durvalumab in lung cancer, run by National Cancer Center Hospital East, not yet recruiting.","summary":"Efficacy and Safety of CRT, Durvalumab and Surgery for SST is a phase 3, interventional study registered as NCT04465968 by National Cancer Center Hospital East, with a registry enrolment figure of 84 participants, started 2020-09-01 and due to reach its primary completion in 2027-08-31. Interventions recorded: Cisplatin; S1; concurrent radiotherapy; Durvalumab; Surgery; Durvalumab. Conditions listed: Superior Sulcus Tumor; Non-small Cell Lung Cancer Stage IIB; Non Small Cell Lung Cancer Stage III. Primary outcome: 3-year overall survival rate (3y-OS). Lung eligibility wording from the registry: \"A definite diagnosis of non-small cell lung cancer has been obtained by biopsy from the primary lesion\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04465968","url":"https://clinicaltrials.gov/study/NCT04465968"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["cisplatin","durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04465968","phase":"3","setting":"Efficacy and Safety of Durvalumab Before and After Operation or Durvalumab as Maintenance Therapy After Chemoradiotherapy Against Superior Sulcus Non-small Cell Lung Cancer","sponsor":"National Cancer Center Hospital East","started":"2020-09-01","startedType":"estimated","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07401537","kind":"trial","name":"Efficacy and Safety of Extended-Dose Interval Immunotherapy Versus Standard-Dose Interval Immunotherapy for Advanced Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, now recruiting.","summary":"Efficacy and Safety of Extended-Dose Interval Immunotherapy Versus Standard-Dose Interval Immunotherapy for Advanced Triple-Negative Breast Cancer is a phase 2, randomised interventional study registered as NCT07401537 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, with a registry enrolment figure of 416 participants, started 2025-12-31 and due to reach its primary completion in 2028-12-31. Interventions recorded: Extended-Dose Interval Immunotherapy; Standard-Dose Interval Immunotherapy. Conditions listed: Triple -Negative Breast Cancer; Breast Cancer. Triple-negative eligibility wording from the registry: \"Advanced (locally recurrent inoperable or metastatic) TNBC confirmed by histology or cytology, defined as ER-negative, PR-negative, and HER2-negative\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07401537","url":"https://clinicaltrials.gov/study/NCT07401537"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07401537","phase":"2","setting":"Efficacy and Safety of Extended-Dose Interval Immunotherapy Versus Standard-Dose Interval Immunotherapy for Advanced Triple-Negative Breast Cancer: A Multicenter Randomized Controlled Clinical Trial","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","started":"2025-12-31","startedType":"actual","enrolled":416,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06698965","kind":"trial","name":"Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and C","aka":[],"tldr":"A phase 2 trial of carboplatin and trilaciclib in lung cancer, run by Shanghai Chest Hospital, now recruiting.","summary":"Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin is a phase 2, randomised interventional study registered as NCT06698965 by Shanghai Chest Hospital, with a registry enrolment figure of 52 participants, started 2024-10-13 and due to reach its primary completion in 2029-10-31. Interventions recorded: Chemotherapy （Etoposide and Carboplatin）; Immunotherapy （Envafolimab）; Trilaciclib. Conditions listed: Lung Cancer, Small Cell. Primary outcome: The incidence of grade ≥ 3 neutropenia during chemotherapy treatment. Lung eligibility wording from the registry: \"* Small cell lung cancer (SCLC) confirmed by histology or cytology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06698965","url":"https://clinicaltrials.gov/study/NCT06698965"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","trilaciclib"],"companies":["simcere"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06698965","phase":"2","setting":"A Randomized, Controlled Phase II Clinical Study on the Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin","sponsor":"Shanghai Chest Hospital","started":"2024-10-13","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07070713","kind":"trial","name":"Efficacy and Safety of FOLFOX+Cetuximab vs. FOLFOXIRI+Bevacizumab Both With QL1706 in First-Line Treatment of Left-Sided mCRC","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Fujian Cancer Hospital, not yet recruiting.","summary":"Efficacy and Safety of FOLFOX+Cetuximab vs. FOLFOXIRI+Bevacizumab Both With QL1706 in First-Line Treatment of Left-Sided mCRC is a phase 2, randomised interventional study registered as NCT07070713 by Fujian Cancer Hospital, with a registry enrolment figure of 44 participants, started 2025-07-30 and due to reach its primary completion in 2028-02-28. Interventions recorded: FOLFOXIRI + QL1706 + Bevacizumab; FOLFOX+QL1706+Cetuximab. Conditions listed: Metastatic Colorectal Cancer With Left-sided Primary Tumor; Immunotherapy. Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed metastatic colorectal adenocarcinoma with the primary tumor located in the left-sided colon (from the splenic flexure to the rectum), including cecal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07070713","url":"https://clinicaltrials.gov/study/NCT07070713"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07070713","phase":"2","setting":"Assess and Compare the Efficacy and Safety of FOLFOX Combined With Cetuximab Versus FOLFOXIRI Combined With Bevacizumab When Both Used in Combination With QL1706 for First-line Treatment of Metastatic Colorectal Cancer With Left-sided Primary Tumors.","sponsor":"Fujian Cancer Hospital","started":"2025-07-30","startedType":"estimated","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05466149","kind":"trial","name":"Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion","aka":[],"tldr":"A phase 2 trial of Furmonertinib in non-small-cell lung cancer, run by Allist Pharmaceuticals, Inc., active and no longer recruiting.","summary":"Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion is a phase 2 interventional study registered as NCT05466149 by Allist Pharmaceuticals, Inc., with 100 participants enrolled, started 2022-09-27 and due to reach its primary completion in 2025-06-27. Interventions recorded: Furmonertinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05466149","url":"https://clinicaltrials.gov/study/NCT05466149"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["furmonertinib"],"companies":["allist"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05466149","phase":"2","setting":"A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations","sponsor":"Allist Pharmaceuticals, Inc.","started":"2022-09-27","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06949982","kind":"trial","name":"Efficacy And Safety Of Hydroxychloroquine Combined With Methotrexate, Capecitabine And Bevacizumab Vs. Regorafenib In Participants With Refractory Metastatic Co","aka":["x-МАР"],"tldr":"A phase 2 trial of regorafenib in colorectal cancer, run by Sergey Orlov, MD, now recruiting.","summary":"Efficacy And Safety Of Hydroxychloroquine Combined With Methotrexate, Capecitabine And Bevacizumab Vs. Regorafenib In Participants With Refractory Metastatic Colorectal Cancer With Mutations In RAS Genes is a phase 2, randomised interventional study registered as NCT06949982 by Sergey Orlov, MD, with a registry enrolment figure of 60 participants, started 2025-03-17 and due to reach its primary completion in 2027-04. Interventions recorded: experimental group x-MAP; Regorafenib (BAY 73-4506). Conditions listed: Metastatic Colorectal Cancer (mCRC); Colorectal Neoplasms. Primary outcome: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). Colorectal eligibility wording from the registry: \"* Histologically confirmed diagnosis of colorectal cancer (CRC) with distant metastases\". Sites: Russia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06949982","url":"https://clinicaltrials.gov/study/NCT06949982"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["regorafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06949982","phase":"2","setting":"A Randomized Trial To Compare Efficacy And Safety Of Hydroxychloroquine Combined With Methotrexate, Capecitabine And Bevacizumab Versus Regorafenib In Participants With Refractory Metastatic Colorectal Cancer With Mutations In RAS Genes","sponsor":"Sergey Orlov, MD","started":"2025-03-17","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06607796","kind":"trial","name":"Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With/Without Chemoimmunotherapy","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Zhou Chengzhi, now recruiting.","summary":"Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With/Without Chemoimmunotherapy is a phase 3, randomised interventional study registered as NCT06607796 by Zhou Chengzhi, with a registry enrolment figure of 180 participants, started 2024-03-01 and due to reach its primary completion in 2026-12. Interventions recorded: Toluenesulfonamide (PTS) Intratumoral Injection. Conditions listed: Lung Cancer. Primary outcome: Objective response rate(ORR). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed stage IV (AJCC 8th edition) driver gene negative non-small cell lung cancer；\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06607796","url":"https://clinicaltrials.gov/study/NCT06607796"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06607796","phase":"3","setting":"A Multicenter Study of the Efficacy and Safety of Intratumoral Injection of Toluenesulfonamide (PTS) in Combination With or Without First-line Chemoimmunotherapy Based on Standard Treatment for Stage IV Driver Gene-negative Non-small Cell Lung Cancer","sponsor":"Zhou Chengzhi","started":"2024-03-01","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07480356","kind":"trial","name":"Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer","aka":[],"tldr":"A phase 3 trial testing TARA-002 in bladder & urothelial cancer, now recruiting.","summary":"Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer is a phase 3 interventional study registered as NCT07480356, led by Protara Therapeutics, and recruiting on the registry. Official title: A Phase 3, Randomised Study to Evaluate the Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-Grade Non-Muscle Invasive Bladder Cancer. Planned enrolment is 284 participants (estimated). The study started in 2026-05-29 and primary completion is expected in 2028-04. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07480356","url":"https://clinicaltrials.gov/study/NCT07480356"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tara-002"],"companies":["protara-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07480356","phase":"3","setting":"A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-Grade Non-Muscle Invasive Bladder Cancer","sponsor":"Protara Therapeutics","started":"2026-05-29","startedType":"actual","enrolled":284,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06319313","kind":"trial","name":"Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2/3 trial of JMT101, docetaxel and HB1801 in lung cancer, run by Shanghai JMT-Bio Inc., not yet recruiting.","summary":"Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer is a phase 2/3, randomised interventional study registered as NCT06319313 by Shanghai JMT-Bio Inc., with a registry enrolment figure of 534 participants, started 2024-05-01 and due to reach its primary completion in 2026-07-01. Interventions recorded: JMT101; docetaxel; HB1801. Conditions listed: Squamous Cell Non-small Cell Lung Cancer. Primary outcome: Overall response rate (ORR); Overall Survival (OS); Incidence and severity of adverse events (AE) and serious adverse events (SAE). Lung eligibility wording from the registry: \"Pathological diagnosis as sqNSCLC, with EGFR highly expressed, without other driver genes\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06319313","url":"https://clinicaltrials.gov/study/NCT06319313"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-squamous-cell-carcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["jmt101","docetaxel","hb1801"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06319313","phase":"2/3","setting":"A Randomized, Controlled, Open-label Phase II/III Study of The Safety, Tolerability and Efficacy of JMT101 Combined With Docetaxel / HB1801 in Patients With sqNSCLC","sponsor":"Shanghai JMT-Bio Inc.","started":"2024-05-01","startedType":"estimated","enrolled":534,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05838066","kind":"trial","name":"Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial testing HB1801 in HER2-positive breast cancer, now recruiting.","summary":"Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer is a phase 3 interventional study registered as NCT05838066, led by Shanghai JMT-Bio, and recruiting on the registry. Official title: A Randomised, Controlled, Open-label, Multicenter, Phase Ш Clinical Study of the Efficacy and Safety of KN026 in Combination With HB1801 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer. Planned enrolment is 880 participants (estimated). The study started in 2023-07-23 and primary completion is expected in 2025-07-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05838066","url":"https://clinicaltrials.gov/study/NCT05838066"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["hb1801"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05838066","phase":"3","setting":"A Randomized, Controlled, Open-label, Multicenter, Phase Ш Clinical Study of the Efficacy and Safety of KN026 in Combination With HB1801 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer","sponsor":"Shanghai JMT-Bio","started":"2023-07-23","startedType":"actual","enrolled":880,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04733183","kind":"trial","name":"Efficacy and Safety of L19TNF in Previously Treated Patients with Advanced Stage or Metastatic Soft-tissue Sarcoma","aka":["FLASH"],"tldr":"A phase 2 trial of Dacarbazine in sarcomas, run by Philogen S.p.A., active and no longer recruiting.","summary":"Efficacy and Safety of L19TNF in Previously Treated Patients with Advanced Stage or Metastatic Soft-tissue Sarcoma is a phase 2 interventional study registered as NCT04733183 by Philogen S.p.A., with 98 participants planned, started 2020-08-28 and due to reach its primary completion in 2025-12. Interventions recorded: Dacarbazine, onfekafusp alfa. Conditions listed: Soft Tissue Sarcoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04733183","url":"https://clinicaltrials.gov/study/NCT04733183"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["dacarbazine"],"companies":["philogen-s-p-a"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04733183","phase":"2","setting":"A Randomized Study to Investigate the Efficacy and Safety of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF in Previously Treated Patients with Advanced Stage or Metastatic Soft-tissue Sarcoma","sponsor":"Philogen S.p.A.","started":"2020-08-28","startedType":"actual","enrolled":98,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06224257","kind":"trial","name":"Efficacy and Safety of Linperlisib in Relapsed/Refractory Large Granular T Lymphocytic Leukemia","aka":[],"tldr":"A phase 2 trial of Linperlisib in Leukaemia, run by Institute of Hematology & Blood Diseases Hospital, China, now recruiting.","summary":"Efficacy and Safety of Linperlisib in Relapsed/Refractory Large Granular T Lymphocytic Leukemia is a phase 2 interventional study registered as NCT06224257 by Institute of Hematology & Blood Diseases Hospital, China, with 41 participants planned, started 2023-12-03 and due to reach its primary completion in 2025-10-31. Interventions recorded: Linperlisib. Conditions recorded: Relapsed/Refractory Large Granular T Lymphocytic Leukemia.\n\nLinked to the drug Linperlisib because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06224257","url":"https://clinicaltrials.gov/study/NCT06224257"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["linperlisib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06224257","phase":"2","setting":"A Phase 2, Multicenter, Single-arm, Open-label Study on the Efficacy and Safety of PI3K Inhibitors in Relapsed/Refractory Large Granular T Lymphocytic Leukemia","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","started":"2023-12-03","startedType":"actual","enrolled":41,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07108504","kind":"trial","name":"Efficacy and Safety of LM-302 Combined With Gemcitabine CLDN 18.2 Positive Unresectable Locally Advanced or Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of gemcitabine and LM-302 in pancreatic cancer, run by Shanghai Zhongshan Hospital, not yet recruiting.","summary":"Efficacy and Safety of LM-302 Combined With Gemcitabine CLDN 18.2 Positive Unresectable Locally Advanced or Metastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT07108504 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 30 participants, started 2025-08-10 and due to reach its primary completion in 2026-08-10. Interventions recorded: Gemcitabine; LM-302. Conditions listed: Pancreatic Cancer; Chemotherapy Effect. Primary outcome: Objective Response Rate (ORR) per RECIST 1.1. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed unresectable, locally advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) not amenable to curative treatment\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07108504","url":"https://clinicaltrials.gov/study/NCT07108504"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","lm-302"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07108504","phase":"2","setting":"An Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of LM-302 Combined With Gemcitabine as Second-line Treatment for CLDN 18.2 Positive Unresectable Locally Advanced or Metastatic Pancreatic Cancer","sponsor":"Shanghai Zhongshan Hospital","started":"2025-08-10","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04844866","kind":"trial","name":"Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients","aka":["DALY 2-EU"],"tldr":"A phase 2 trial of Zamtocabtagene autoleucel, Rituximab, Gemcitabine in diffuse large b-cell lymphoma, run by Miltenyi Biomedicine GmbH, now recruiting.","summary":"Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients is a phase 2 interventional study registered as NCT04844866 by Miltenyi Biomedicine GmbH, with 213 participants planned, started 2021-08-18 and due to reach its primary completion in 2025-01-15. Interventions recorded: MB-CART2019.1, Standard of Care. Conditions listed: Diffuse Large B-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04844866","url":"https://clinicaltrials.gov/study/NCT04844866"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["zamtocabtagene-autoleucel","rituximab","gemcitabine","capox","polatuzumab-vedotin","bendamustine"],"companies":["miltenyi-biomedicine"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04844866","phase":"2","setting":"A Pivotal Phase II Randomised, Multi-centre, Open-label Study to Evaluate the Efficacy and Safety of MB-CART2019.1 Compared to SoC Therapy in Participants With r/r DLBCL, Who Are Not Eligible for HDC and ASCT","sponsor":"Miltenyi Biomedicine GmbH","started":"2021-08-18","startedType":"actual","enrolled":213,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06028633","kind":"trial","name":"Efficacy and Safety of Nab-paclitaxel-Lenvatinib-Pembrolizumab as Second-line Treatment in Advanced NSCLC Patients","aka":[],"tldr":"A phase 2 trial of pembrolizumab, lenvatinib and nab-paclitaxel in lung cancer, run by Peking University First Hospital, not yet recruiting.","summary":"Efficacy and Safety of Nab-paclitaxel-Lenvatinib-Pembrolizumab as Second-line Treatment in Advanced NSCLC Patients is a phase 2, interventional study registered as NCT06028633 by Peking University First Hospital, with a registry enrolment figure of 28 participants, started 2023-10 and due to reach its primary completion in 2024-10. Interventions recorded: pembrolizumab; lenvatinib; albumin-bound paclitaxel. Conditions listed: Advanced Non-squamous Non-small-cell Lung Cancer; Recurrent Non-Squamous Non-Small Cell Lung Cancer; Metastatic Non-squamous Non Small Cell Lung Cancer. Primary outcome: Objective response rate. Lung eligibility wording from the registry: \"Male/female participants who are at least 18 years of age on the day of signing informed consent (ICF) with histologically confirmed diagnosis of metastatic nonsquamous NSCLC (AJCC Staging Manual, Version 8) will be enrolled in this study\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06028633","url":"https://clinicaltrials.gov/study/NCT06028633"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["pembrolizumab","lenvatinib","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06028633","phase":"2","setting":"Efficacy and Safety of Albumin-bound Paclitaxel-Lenvatinib-Pembrolizumab in Advanced Nonsquamous NSCLC Patients After Progression to First-line Anti-PD-1/L1 Inhibitor With Platinum-doublet Chemotherapy","sponsor":"Peking University First Hospital","started":"2023-10","startedType":"estimated","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07379047","kind":"trial","name":"Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)","aka":["GISTAR-1"],"tldr":"A phase 2/3 trial testing NB003 in gastrointestinal stromal tumour, now recruiting.","summary":"Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumours (GIST) is a phase 2/3 interventional study registered as NCT07379047, led by Ningbo Newbay Technology Development, and recruiting on the registry. Official title: A Multicenter, Open-label Clinical Study to Evaluate the Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumours (GIST). Planned enrolment is 255 participants (estimated). The study started in 2026-05-11 and primary completion is expected in 2028-08-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07379047","url":"https://clinicaltrials.gov/study/NCT07379047"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gist"],"sections":[],"technologies":[],"targets":[],"drugs":["nb003"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07379047","phase":"2/3","setting":"A Multicenter, Open-label Clinical Study to Evaluate the Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)","sponsor":"Ningbo Newbay Technology Development","started":"2026-05-11","startedType":"actual","enrolled":255,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04728893","kind":"trial","name":"Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)","aka":[],"tldr":"A phase 2 trial of Nemtabrutinib in chronic lymphocytic leukaemia, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003) is a phase 2 interventional study registered as NCT04728893 by Merck Sharp & Dohme LLC, with 490 participants planned, started 2021-04-05 and due to reach its primary completion in 2029-01-04. Interventions recorded: Nemtabrutinib. Conditions listed: Hematologic Malignancies, Waldenstroms Macroglobulinaemia, Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukaemia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04728893","url":"https://clinicaltrials.gov/study/NCT04728893"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cll"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["nemtabrutinib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04728893","phase":"2","setting":"A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies","sponsor":"Merck Sharp & Dohme LLC","started":"2021-04-05","startedType":"actual","enrolled":490,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03742895","kind":"trial","name":"Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002)","aka":["LYNK-002"],"tldr":"A phase 2 trial of Olaparib in advanced solid tumours, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002) is a phase 2 interventional study registered as NCT03742895 by Merck Sharp & Dohme LLC, with 329 participants enrolled, started 2018-12-12 and due to reach its primary completion in 2025-08-12. Interventions recorded: Olaparib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03742895","url":"https://clinicaltrials.gov/study/NCT03742895"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["olaparib"],"companies":["merck","astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03742895","phase":"2","setting":"A Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer","sponsor":"Merck Sharp & Dohme LLC","started":"2018-12-12","startedType":"actual","yearReported":2026,"enrolled":329,"enrolledBasis":"registry","outcomes":[{"endpoint":"Cohorts 1, 2, 3: Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-Modified RECIST 1.1","primary":true,"unit":"%","arms":[{"name":"Cohort 1: BRCA1/2 Mutated","n":86,"value":16.3,"note":"95% CI 9.2 to 25.8; Figures from the ClinicalTrials.gov results section (first posted 2026-08-14), not from a publication"},{"name":"Cohort 2: HRD+, HRR Non-mutated","n":90,"value":8.9,"note":"95% CI 3.9 to 16.8"},{"name":"Cohort 2: HRRm, BRCA1/2 Non-mutated","n":140,"value":8.6,"note":"95% CI 4.5 to 14.5"},{"name":"Cohort 3: sBRCAm Breast Cancer","n":7,"value":28.6,"note":"95% CI 3.7 to 71.0"}],"source":"https://clinicaltrials.gov/study/NCT03742895?tab=results"}]},{"id":"nct06082102","kind":"trial","name":"Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma","aka":[],"tldr":"A phase 3 trial of Orelabrutinib, Rituximab and Lenalidomide in non-Hodgkin lymphoma, run by Beijing InnoCare Pharma Tech Co., Ltd., now recruiting.","summary":"Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma is a phase 3 interventional study registered as NCT06082102 by Beijing InnoCare Pharma Tech Co., Ltd., with 324 participants planned, started 2023-12-19 and due to reach its primary completion in 2028-08-31. Interventions recorded: Orelabrutinib, Rituximab and Lenalidomide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06082102","url":"https://clinicaltrials.gov/study/NCT06082102"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","marginal-zone-lymphoma"],"sections":[],"technologies":["kinase-inhibitors","monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["orelabrutinib","rituximab","lenalidomide"],"companies":["innocare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06082102","phase":"3","setting":"A Randomized, Controlled, Open-label, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Orelabrutinib Plus Rituximab Versus Lenalidomide Plus Rituximab in Relapsed/Refractory Marginal Zone Lymphoma","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","started":"2023-12-19","startedType":"actual","enrolled":324,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00880269","kind":"trial","name":"Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)","aka":[],"tldr":"A phase 2 trial of Panobinostat in Leukaemia, run by Novartis Pharmaceuticals, completed.","summary":"Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML) is a phase 2 interventional study registered as NCT00880269 by Novartis Pharmaceuticals, with 59 participants recorded, started 2009-08 and reaching its primary completion in 2012-02. Interventions recorded: Panobinostat/LBH589. Conditions recorded: Refractory Leukemia, Acute Myelogenous Leukemia.\n\nLinked to the drug Panobinostat because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00880269","url":"https://clinicaltrials.gov/study/NCT00880269"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["panobinostat"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00880269","phase":"2","setting":"A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)","sponsor":"Novartis Pharmaceuticals","started":"2009-08","enrolled":59,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01137682","kind":"trial","name":"Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly","aka":["PAOLA"],"tldr":"A phase 3 trial of Pasireotide in Pituitary tumours, run by Novartis Pharmaceuticals, completed.","summary":"Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly is a phase 3 interventional study registered as NCT01137682 by Novartis Pharmaceuticals, with 198 participants recorded, started 2010-07-19 and reaching its primary completion in 2013-01-22. Interventions recorded: Pasireotide, octreotide LAR 30mg, lanreotide ATG 120mg. Conditions recorded: Acromegaly.\n\nLinked to the drug Pasireotide because the registry names it among its interventions and Pituitary tumours among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01137682","url":"https://clinicaltrials.gov/study/NCT01137682"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pituitary-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["pasireotide"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01137682","phase":"3","setting":"A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly","sponsor":"Novartis Pharmaceuticals","started":"2010-07-19","startedType":"actual","yearReported":2015,"enrolled":198,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.","primary":true,"unit":"%","arms":[{"name":"Pasireotide LAR 40 mg","n":65,"value":15.4,"note":"95% CI 7.63 to 26.48; Figures from the ClinicalTrials.gov results section (first posted 2015-01-21), not from a publication"},{"name":"Pasireotide LAR 60 mg","n":65,"value":20,"note":"95% CI 11.10 to 31.77"},{"name":"Control Arm (Octreotide or Lanreotide)","n":68,"value":0,"note":"95% CI 0 to 5.28"}],"source":"https://clinicaltrials.gov/study/NCT01137682?tab=results"}]},{"id":"nct06050122","kind":"trial","name":"Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome","aka":[],"tldr":"A phase 3 trial of Patidegib Topical Gel in basal cell carcinoma, run by Sol-Gel Technologies, Ltd., now completed.","summary":"Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome is a phase 3 interventional study registered as NCT06050122 by Sol-Gel Technologies, Ltd., with 140 participants enrolled, started 2024-03-17 and reached its primary completion in 2026-08-20. Interventions recorded: Patidegib Topical Gel and Patidegib Topical Gel with no active patidegib.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06050122","url":"https://clinicaltrials.gov/study/NCT06050122"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["basal-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["patidegib"],"companies":[],"institutions":[],"pathways":[],"terms":["hedgehog-inhibitor-tolerability"],"trials":["patidegib-gel-gorlin-phase-2","stevie"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registry status on 22 September 2026: Completed (registry record last updated 18 September 2026; primary completion reached 20 August 2026)."],"nct":"NCT06050122","phase":"3","setting":"A Multicenter, Randomized, Double Blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Gel 2% for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Gorlin Syndrome","sponsor":"Sol-Gel Technologies, Ltd.","started":"2024-03-17","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06229067","kind":"trial","name":"Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With Metronomic VEX in Advanced Triple-negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of adebrelimab, vinorelbine, cyclophosphamide and capecitabine in triple-negative breast cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, not yet recruiting.","summary":"Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With Metronomic VEX in Advanced Triple-negative Breast Cancer is a phase 2, randomised interventional study registered as NCT06229067 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 182 participants, started 2024-01-19 and due to reach its primary completion in 2025-01-19. Interventions recorded: Adebrelimab; Vinorelbine; Cyclophosphamide (tablet); Capecitabine. Conditions listed: Breast Cancer; Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Participants with clear clinical records of metastatic triple-negative breast cancer, as specified in the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06229067","url":"https://clinicaltrials.gov/study/NCT06229067"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["adebrelimab","vinorelbine","cyclophosphamide","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06229067","phase":"2","setting":"Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With Metronomic Chemotherapy of Vinorelbine, Cyclophosphamide and Capecitabine (VEX) Regime in Advanced Triple-negative Breast Cancer: a Multicenter, Randomized, Phase II Study","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2024-01-19","startedType":"estimated","enrolled":182,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03711032","kind":"trial","name":"Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)","aka":["KEYNOTE-676"],"tldr":"A phase 3 trial of Pembrolizumab in bladder & urothelial cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676) is a phase 3 interventional study registered as NCT03711032 by Merck Sharp & Dohme LLC, with 1397 participants enrolled, started 2018-12-24 and due to reach its primary completion in 2026-07-31. Interventions recorded: Pembrolizumab and BCG.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03711032","url":"https://clinicaltrials.gov/study/NCT03711032"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03711032","phase":"3","setting":"A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)","sponsor":"Merck Sharp & Dohme LLC","started":"2018-12-24","startedType":"actual","enrolled":1397,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04241185","kind":"trial","name":"Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)","aka":["KEYNOTE-992"],"tldr":"A phase 3 trial of Pembrolizumab, Cisplatin, Fluorouracil (5-FU), Mitomycin C and Gemcitabine in bladder & urothelial cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) is a phase 3 interventional study registered as NCT04241185 by Merck Sharp & Dohme LLC, with 520 participants enrolled, started 2020-05-19 and due to reach its primary completion in 2027-01-31. Interventions recorded: Pembrolizumab, Conventional Radiotherapy (Bladder only), Conventional Radiotherapy (Bladder and pelvic nodes), Hypofractionated Radiotherapy (Bladder only), Cisplatin and Fluorouracil (5-FU).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04241185","url":"https://clinicaltrials.gov/study/NCT04241185"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","cisplatin","fluorouracil","mitomycin","gemcitabine"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04241185","phase":"3","setting":"A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Participants With Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)","sponsor":"Merck Sharp & Dohme LLC","started":"2020-05-19","startedType":"actual","enrolled":520,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01876043","kind":"trial","name":"Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma (DLPS): an Exploratory Phase II Multicenter Trial","aka":[],"tldr":"A phase 2 trial of Plitidepsin in Liposarcoma, run by Institut Bergonié, recorded as terminated on the registry.","summary":"Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma (DLPS): an Exploratory Phase II Multicenter Trial is a phase 2 interventional study registered as NCT01876043 by Institut Bergonié, with 24 participants recorded, started 2012-02 and due to reach its primary completion in 2015-04. Interventions recorded: plitidepsin. Conditions recorded: Adult Patients With Unresectable Locally Advanced or Metastatic, Relapsed/Refractory Dedifferentiated Liposarcoma.\n\nLinked to the drug Plitidepsin because the registry names it among its interventions and Liposarcoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01876043","url":"https://clinicaltrials.gov/study/NCT01876043"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["liposarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["plitidepsin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01876043","phase":"2","setting":"Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma (DLPS): an Exploratory Phase II Multicenter Trial","sponsor":"Institut Bergonié","started":"2012-02","yearReported":2019,"enrolled":24,"enrolledBasis":"registry","outcomes":[{"endpoint":"1-year Overall Survival (OS) Rate","unit":"%","arms":[{"name":"Plitidepsin","n":22,"value":40.9,"note":"95% CI 20.9 to 60.1; Figures from the ClinicalTrials.gov results section (first posted 2019-11-12), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01876043?tab=results"},{"endpoint":"Progression-free Survival","unit":"months","arms":[{"name":"Plitidepsin","n":22,"value":1.6,"note":"95% CI 1.4 to 2.6; Figures from the ClinicalTrials.gov results section (first posted 2019-11-12), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01876043?tab=results"}]},{"id":"nct07636824","kind":"trial","name":"Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma: A Multicenter Prospective Phase II Study","aka":[],"tldr":"A phase 2 trial of capecitabine and S-1 with radiotherapy in gallbladder cancer and other biliary tract cancers, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma: A Multicenter Prospective Phase II Study is a phase 2 interventional study registered as NCT07636824 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 92 participants, started 2026-06-16 and due to reach its primary completion in 2029-02-28. Interventions recorded: Postoperative radiotherapy, Capecitabine or S-1. Conditions listed: Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07636824","url":"https://clinicaltrials.gov/study/NCT07636824"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","extrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine","tegafur-gimeracil-oteracil"],"companies":[],"institutions":[],"pathways":[],"terms":["chemoradiation","radiotherapy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07636824","phase":"2","setting":"Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma: A Multicenter Prospective Phase II Study","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2026-06-16","startedType":"actual","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04829708","kind":"trial","name":"Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission Aft","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Shandong Cancer Hospital and Institute, now recruiting.","summary":"Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy is a phase 3, randomised interventional study registered as NCT04829708 by Shandong Cancer Hospital and Institute, with a registry enrolment figure of 534 participants, started 2021-04-26 and due to reach its primary completion in 2026-04-15. Interventions recorded: MRI Surveillance; Prophylactic Cranial Irradiation. Conditions listed: Limited Stage Small Cell Lung Cancer. Primary outcome: Overall survival (OS). Lung eligibility wording from the registry: \"Histological or cytological confirmation of LS-SCLC before first-line chemoradiotherapy (according to the staging system of the Veterans' Affairs Lung Study Group (VALSG), Appendix 2)；\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04829708","url":"https://clinicaltrials.gov/study/NCT04829708"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["limited-stage-sclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04829708","phase":"3","setting":"Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy: a Multicenter Randomized Controlled Phase III Clinical Trial","sponsor":"Shandong Cancer Hospital and Institute","started":"2021-04-26","startedType":"estimated","enrolled":534,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05918302","kind":"trial","name":"Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.","aka":["LEVEL"],"tldr":"A phase 3 trial of 177Lu-edotreotide and everolimus in lung cancer, run by Grupo Espanol de Tumores Neuroendocrinos, now recruiting.","summary":"Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus. is a phase 3, randomised interventional study registered as NCT05918302 by Grupo Espanol de Tumores Neuroendocrinos, with a registry enrolment figure of 170 participants, started 2023-10-27 and due to reach its primary completion in 2029-03. Interventions recorded: 177Lu-edotreotide; Everolimus. Conditions listed: Neuroendocrine Tumors; Lung Neuroendocrine Neoplasm; Thymus Neoplasms. Primary outcome: Progression-free survival (PFS). Lung eligibility wording from the registry: \"Patients who have histologically confirmed metastatic or locally advanced unresectable well/moderately differentiated; World Health Organization (WHO\\]) 2015 criteria; neuroendocrine tumor of lung (typical and atypical carcinoids) or thymus origin either functioning or non-functioning\". Sites: Belgium, France, Italy, Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05918302","url":"https://clinicaltrials.gov/study/NCT05918302"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["itm-11","everolimus"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05918302","phase":"3","setting":"Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy With 177Lu-edotreotide Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.","sponsor":"Grupo Espanol de Tumores Neuroendocrinos","started":"2023-10-27","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07728019","kind":"trial","name":"Efficacy and Safety of Retlirafusp Alfa Plus Bevacizumab and Chemotherapy With or Without Short-Course Radiotherapy in Patients With CRCLM","aka":[],"tldr":"A phase 2 trial of bevacizumab (glioblastoma use) and cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, now recruiting.","summary":"Efficacy and Safety of Retlirafusp Alfa Plus Bevacizumab and Chemotherapy With or Without Short-Course Radiotherapy in Patients With CRCLM is a phase 2, interventional study registered as NCT07728019 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 60 participants, started 2026-07-30 and due to reach its primary completion in 2029-06-30. Interventions recorded: SCRT; Retlirafusp alfa Injection; Bevacizumab; CAPOX. Conditions listed: CRC (Colorectal Cancer). Primary outcome: Progression-Free Survival. Colorectal eligibility wording from the registry: \"Histologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07728019","url":"https://clinicaltrials.gov/study/NCT07728019"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["bevacizumab-glioma","capox"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07728019","phase":"2","setting":"Efficacy and Safety of Retlirafusp Alfa Plus Bevacizumab and Chemotherapy With or Without Short-Course Radiotherapy in Patients With Colorectal Cancer Liver Metastases: a Randomized Phase II Study","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2026-07-30","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07638501","kind":"trial","name":"Efficacy and Safety of SBRT Plus Gemcitabine, Cisplatin, and Sintilimab as First-Line Treatment for Unresectable Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of sintilimab, gemcitabine and cisplatin with radiotherapy in gallbladder cancer and other biliary tract cancers, run by Eastern Hepatobiliary Surgery Hospital, not yet recruiting.","summary":"Efficacy and Safety of SBRT Plus Gemcitabine, Cisplatin, and Sintilimab as First-Line Treatment for Unresectable Biliary Tract Cancer is a phase 2, randomised interventional study registered as NCT07638501 by Eastern Hepatobiliary Surgery Hospital, with a registry enrolment figure of 123 participants, started 2026-06-15 and due to reach its primary completion in 2028-06-15. Interventions recorded: Sintilimab + GC, SBRT 7Gy✖️5 QD. Conditions listed: Biliary Tract Cancer (BTC). Gallbladder cancer is named in the registry entry: \"3. Histologically or cytologically confirmed, unresectable advanced or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07638501","url":"https://clinicaltrials.gov/study/NCT07638501"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","sbrt"],"targets":[],"drugs":["sintilimab","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":["radiotherapy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07638501","phase":"2","setting":"Evaluation of the Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT) Combined With Gemcitabine, Cisplatin, and Sintilimab as First-Line Therapy for Unresectable Biliary Tract Cancer: A Prospective, Multicenter, Randomized Controlled Study","sponsor":"Eastern Hepatobiliary Surgery Hospital","started":"2026-06-15","startedType":"estimated","enrolled":123,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07545213","kind":"trial","name":"Efficacy and Safety of SKB264 Plus Anlotinib in EGFR-TKI-Resistant Advanced NSCLC With Liver Metastasis","aka":[],"tldr":"A phase 2 trial of sacituzumab tirumotecan in lung cancer, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine, not yet recruiting.","summary":"Efficacy and Safety of SKB264 Plus Anlotinib in EGFR-TKI-Resistant Advanced NSCLC With Liver Metastasis is a phase 2, interventional study registered as NCT07545213 by The Fourth Affiliated Hospital of Zhejiang University School of Medicine, with a registry enrolment figure of 27 participants, started 2026-04-20 and due to reach its primary completion in 2028-02-15. Interventions recorded: SKB264. Conditions listed: Non-small Cell Lung Cancer; EGFR Mutant Advanced Non-small Cell Lung Cancer. Primary outcome: Objective Response Rate (ORR). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is locally advanced (stage IIIB/IIIC) or metastatic (stage IV) and not amenable to curative surgery and/or curative radiotherapy (with or without concurrent chemotherapy), according to the IASLC 9th edition lung cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07545213","url":"https://clinicaltrials.gov/study/NCT07545213"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-tirumotecan"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07545213","phase":"2","setting":"Efficacy and Safety of SKB264 Plus Anlotinib in EGFR-TKI-Resistant Advanced NSCLC With Liver Metastasis","sponsor":"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","started":"2026-04-20","startedType":"estimated","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05872347","kind":"trial","name":"Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.","aka":[],"tldr":"A phase 2 trial of SPH4336 in brain and spinal cord tumours, run by Shanghai Pharmaceuticals Holding Co., Ltd, now recruiting.","summary":"Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases. is a phase 2 interventional study registered as NCT05872347 by Shanghai Pharmaceuticals Holding Co., Ltd, with 52 participants planned, started 2023-09-19 and due to reach its primary completion in 2026-12-31. Interventions recorded: SPH4336 Tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05872347","url":"https://clinicaltrials.gov/study/NCT05872347"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["brain-tumours","secondary-brain-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["sph4336"],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05872347","phase":"2","setting":"A Phase II Study of SPH4336 in Combination With Endocrine Therapy in HR-positive, HER2-negative Breast Cancer Patients With Brain Metastases.","sponsor":"Shanghai Pharmaceuticals Holding Co., Ltd","started":"2023-09-19","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06189209","kind":"trial","name":"Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)","aka":[],"tldr":"A phase 2 trial of Tenalisib in triple-negative breast cancer, run by Rhizen Pharmaceuticals SA, now recruiting.","summary":"Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC) is a phase 2 interventional study registered as NCT06189209 by Rhizen Pharmaceuticals SA, with 40 participants planned, started 2024-03-04 and due to reach its primary completion in 2026-12-31. Interventions recorded: Tenalisib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06189209","url":"https://clinicaltrials.gov/study/NCT06189209"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["tenalisib"],"companies":["rhizen-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06189209","phase":"2","setting":"A Phase II, Multi-center, Single-arm, Open-label Study to Assess the Efficacy and Safety of Tenalisib, a PI3K δ/γ, and SIK3 Inhibitor, in Patients With Metastatic Triple Negative Breast Cancer (TNBC)","sponsor":"Rhizen Pharmaceuticals SA","started":"2024-03-04","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07498478","kind":"trial","name":"Efficacy and Safety of Tinengotinib Tablets Combined With Fulvestrant Injection in Patients With HR Positive and HER-2 Negative Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment","aka":[],"tldr":"A phase 2 trial of Fulvestrant and Tinengotinib in HR-positive / HER2-negative breast cancer, run by TransThera Sciences (Nanjing), Inc., now recruiting.","summary":"Efficacy and Safety of Tinengotinib Tablets Combined With Fulvestrant Injection in Patients With HR Positive and HER-2 Negative Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment is a phase 2 interventional study registered as NCT07498478 by TransThera Sciences (Nanjing), Inc., with 94 participants planned, started 2026-03-17 and due to reach its primary completion in 2027-06-30. Interventions recorded: Tinengotinib at the optimal dose combined with Fulvestrant, Tinengotinib and tinengotinib combined with fulvestrant.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07498478","url":"https://clinicaltrials.gov/study/NCT07498478"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy","kinase-inhibitors"],"targets":[],"drugs":["fulvestrant","tinengotinib"],"companies":["transthera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07498478","phase":"2","setting":"A Phase II, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of TT-00420 (Tinengotinib) Tablets Combined With Fulvestrant Injection in Patients With Hormone Receptor-Positive (HR+) and Human Epidermal Growth Factor Receptor 2 (HER-2) Negative or Low-Expressing Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment","sponsor":"TransThera Sciences (Nanjing), Inc.","started":"2026-03-17","startedType":"actual","enrolled":94,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05116072","kind":"trial","name":"Efficacy and Safety of TPIAT for Resectable Adenocarcinoma of the Pancreas Region at High Risk of Postoperative Fistula","aka":["TPIAT-01"],"tldr":"A phase 1/2 trial in pancreatic cancer, run by University Hospital, Lille, now recruiting.","summary":"Efficacy and Safety of TPIAT for Resectable Adenocarcinoma of the Pancreas Region at High Risk of Postoperative Fistula is a phase 1/2, interventional study registered as NCT05116072 by University Hospital, Lille, with a registry enrolment figure of 36 participants, started 2022-02-20 and due to reach its primary completion in 2028-02-20. Interventions recorded: total pancreatectomy; intraportal islet autotransplantation. Conditions listed: Adenocarcinoma of the Pancreas; Adenocarcinoma of the Duodenum; Ampullary Adenocarcinoma. Primary outcome: the rate of patients who have completed the chemotherapy planned. Pancreatic eligibility wording from the registry: \"Inclusion criteria are composed of preoperative conditions validated by intraoperative confirmation to plan an exit of the protocol if the pancreas does not finally appear with a high-risk of CR-POPF\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05116072","url":"https://clinicaltrials.gov/study/NCT05116072"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05116072","phase":"1/2","setting":"Efficacy and Safety of Total Pancreatectomy With Intraportal Islet Autotransplantation for Resectable Adenocarcinoma of the Cephalic Region of the Pancreas at High-risk of Postoperative Fistula and Requiring Systemic Adjuvant Chemotherapy","sponsor":"University Hospital, Lille","started":"2022-02-20","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07108127","kind":"trial","name":"Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Treatment of Patients With Locally Advanced","aka":["NePHera"],"tldr":"A phase 2 trial in colorectal cancer, run by Peking Union Medical College Hospital, now recruiting.","summary":"Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Treatment of Patients With Locally Advanced HER2-positive Rectal Cancer is a phase 2, interventional study registered as NCT07108127 by Peking Union Medical College Hospital, with a registry enrolment figure of 24 participants, started 2025-06-20 and due to reach its primary completion in 2026-12-01. Interventions recorded: Trastuzumab biosimilars and pertuzumab biosimilars plus XELOX. Conditions listed: Rectal Cancer; HER2-positive. Primary outcome: CR. Colorectal eligibility wording from the registry: \"Patients with rectal cancer confirmed by histology or cytology; locally advanced (cT3/T4, N+, distance from the lower edge of the tumor to the anal verge ≤ 12 cm) rectal adenocarcinoma (using the 8th edition of the AJCC TNM staging);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07108127","url":"https://clinicaltrials.gov/study/NCT07108127"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","her2-amplified-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07108127","phase":"2","setting":"Phase II Clinical Study on the Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Treatment of Patients With Locally Advanced HER2-positive Rectal Cancer","sponsor":"Peking Union Medical College Hospital","started":"2025-06-20","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07714447","kind":"trial","name":"Efficacy and Safety of Tunlametinib Combination Therapy in the Treatment of Second-line and Above Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"Efficacy and Safety of Tunlametinib Combination Therapy in the Treatment of Second-line and Above Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07714447 by Sun Yat-sen University, with a registry enrolment figure of 91 participants, started 2026-11-30 and due to reach its primary completion in 2029-02-01. Interventions recorded: Arm1; Arm 2; Arm 3. Conditions listed: CRC (Colorectal Cancer); BRAF. Primary outcome: Objective Response Rate (ORR). Colorectal eligibility wording from the registry: \"* Patients with metastatic colorectal cancer confirmed by histology or cytology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07714447","url":"https://clinicaltrials.gov/study/NCT07714447"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07714447","phase":"2","setting":"Efficacy and Safety of Tunlametinib Combination Therapy in the Treatment of Second-line and Above Metastatic Colorectal Cancer: a Multicentre, Multicohort, Phase 2 Trial.","sponsor":"Sun Yat-sen University","started":"2026-11-30","startedType":"estimated","enrolled":91,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06008119","kind":"trial","name":"Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 3 trial of Tunlametinib run by Shanghai Kechow Pharma, Inc. in colorectal cancer, now recruiting.","summary":"Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer is a phase 3 interventional study registered as NCT06008119 by Shanghai Kechow Pharma, Inc., with 165 participants planned, started 2023-10-25. Conditions listed: Colorectal Cancer Metastatic. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06008119","url":"https://clinicaltrials.gov/study/NCT06008119"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","braf-v600e-colorectal"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["tunlametinib"],"companies":["shanghai-kechow-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06008119","phase":"3","setting":"A Multicenter, Randomized, Open-label, Phase 3 Study to Evaluate the Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer","sponsor":"Shanghai Kechow Pharma, Inc.","started":"2023-10-25","startedType":"actual","enrolled":165,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06995677","kind":"trial","name":"Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer","aka":["SURF302"],"tldr":"A phase 2 trial of TYRA-300 in bladder & urothelial cancer, run by Tyra Biosciences, Inc, now recruiting.","summary":"Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer is a phase 2 interventional study registered as NCT06995677 by Tyra Biosciences, Inc, with 90 participants planned, started 2025-06-27 and due to reach its primary completion in 2028-02. Interventions recorded: TYRA-300 60mg, TYRA-300 50mg and TYRA-300 Dose TBD.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06995677","url":"https://clinicaltrials.gov/study/NCT06995677"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tyra-300"],"companies":["tyra-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06995677","phase":"2","setting":"A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)","sponsor":"Tyra Biosciences, Inc","started":"2025-06-27","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06642545","kind":"trial","name":"Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer","aka":[],"tldr":"A phase 2 trial of Disitamab vedotin, RC148 and Toripalimab in HER2-positive breast cancer, run by RemeGen Co., Ltd., now recruiting.","summary":"Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer is a phase 2 interventional study registered as NCT06642545 by RemeGen Co., Ltd., with 40 participants planned, started 2025-02-10 and due to reach its primary completion in 2026-10-01. Interventions recorded: Disitamab Vedotin, RC148, Albumin-bound Paclitaxone and Toripalimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06642545","url":"https://clinicaltrials.gov/study/NCT06642545"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["disitamab-vedotin","rc148","toripalimab"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06642545","phase":"2","setting":"A Randomized, Open-label, Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With RC148 Versus Albumin-bound Paclitaxone Alone or in Combination With Toripalimab in Subjects With HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer","sponsor":"RemeGen Co., Ltd.","started":"2025-02-10","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05374915","kind":"trial","name":"Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC)","aka":[],"tldr":"A phase 2 trial of REM-001 photodynamic therapy in advanced solid tumours, run by Kintara Therapeutics, Inc., active and no longer recruiting.","summary":"Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC) is a phase 2 interventional study registered as NCT05374915 by Kintara Therapeutics, Inc., with 15 participants enrolled, started 2024-02-12 and due to reach its primary completion in 2025-12-30. Interventions recorded: REM-001 photodynamic therapy.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05374915","url":"https://clinicaltrials.gov/study/NCT05374915"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05374915","phase":"2","setting":"An Open-Labeled, Single Arm Phase 2 Efficacy and Safety Study of REM-001 Photodynamic Therapy (PDT) for Treatment of Cutaneous Metastatic Breast Cancer (CMBC) That is Refractory or Not Eligible for Radiotherapy or Surgery","sponsor":"Kintara Therapeutics, Inc.","started":"2024-02-12","startedType":"actual","enrolled":15,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00769704","kind":"trial","name":"Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma","aka":[],"tldr":"A phase 3 trial of Talimogene laherparepvec and Sargramostim in Melanoma, run by BioVex Limited, completed.","summary":"Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma is a phase 3 interventional study registered as NCT00769704 by BioVex Limited, with 437 participants recorded, started 2009-04 and reaching its primary completion in 2013-02. Interventions recorded: Talimogene laherparepvec, GM-CSF. Conditions recorded: Melanoma.\n\nLinked to the drug Talimogene laherparepvec because the registry names it among its interventions and Melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00769704","url":"https://clinicaltrials.gov/study/NCT00769704"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["talimogene-laherparepvec","sargramostim"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00769704","phase":"3","setting":"A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEX^GM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease","sponsor":"BioVex Limited","started":"2009-04","yearReported":2015,"enrolled":437,"enrolledBasis":"registry","outcomes":[{"endpoint":"Durable Response Rate","primary":true,"unit":"%","arms":[{"name":"GM-CSF","n":141,"value":2.1,"note":"95% CI 0.0 to 4.5; Figures from the ClinicalTrials.gov results section (first posted 2015-12-17), not from a publication"},{"name":"Talimogene Laherparepvec","n":295,"value":16.3,"note":"95% CI 12.1 to 20.5"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT00769704?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"GM-CSF","n":141,"value":18.9,"note":"95% CI 16.0 to 23.7; Figures from the ClinicalTrials.gov results section (first posted 2015-12-17), not from a publication"},{"name":"Talimogene Laherparepvec","n":295,"value":23.3,"note":"95% CI 19.5 to 29.6"}],"hr":0.79,"ci":[0.62,1],"p":"0.0511","source":"https://clinicaltrials.gov/study/NCT00769704?tab=results"},{"endpoint":"Objective Response Rate","unit":"%","arms":[{"name":"GM-CSF","n":141,"value":5.7,"note":"95% CI 1.9 to 9.5; Figures from the ClinicalTrials.gov results section (first posted 2015-12-17), not from a publication"},{"name":"Talimogene Laherparepvec","n":295,"value":26.4,"note":"95% CI 21.4 to 31.5"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT00769704?tab=results"}]},{"id":"nct03485209","kind":"trial","name":"Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors","aka":[],"tldr":"A phase 2 trial of Tisotumab vedotin, Pembrolizumab, Carboplatin and Cisplatin in colorectal cancer, non-small-cell lung cancer, pancreatic ductal adenocarcinoma and head and neck squamous cell carcinoma, run by Seagen, a wholly owned subsidiary of Pfizer, active and no longer recruiting.","summary":"Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors is a phase 2 interventional study registered as NCT03485209 by Seagen, a wholly owned subsidiary of Pfizer, with 350 participants enrolled, started 2018-06-25 and due to reach its primary completion in 2026-03-20. Interventions recorded: tisotumab vedotin, pembrolizumab, carboplatin and cisplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03485209","url":"https://clinicaltrials.gov/study/NCT03485209"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","nsclc","pancreatic","head-and-neck"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["tisotumab-vedotin","pembrolizumab","carboplatin","cisplatin"],"companies":["genmab","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03485209","phase":"2","setting":"Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors","sponsor":"Seagen, a wholly owned subsidiary of Pfizer","started":"2018-06-25","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01310894","kind":"trial","name":"Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance","aka":["PCM301","CLIN1001 PCM301","TOOKAD Soluble phase 3"],"tldr":"A phase 3 trial of Padeliporfin in Prostate cancer, run by Steba Biotech S.A., completed.","summary":"Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance is a phase 3 interventional study registered as NCT01310894 by Steba Biotech S.A., with 413 participants recorded, started 2011-02 and reaching its primary completion in 2015-06. Interventions recorded: TOOKAD® Soluble. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Padeliporfin because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01310894","url":"https://clinicaltrials.gov/study/NCT01310894"},{"label":"PCM301 padeliporfin against active surveillance (Lancet Oncology 2017)","url":"https://doi.org/10.1016/S1470-2045(16)30661-1"},{"label":"NICE TA546: padeliporfin for untreated localised prostate cancer, not recommended","url":"https://www.nice.org.uk/guidance/ta546"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-low-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["padeliporfin"],"companies":["steba-biotech"],"institutions":[],"pathways":[],"terms":["prostate-focal-therapy"],"trials":["protect"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["PCM301 randomised 413 men with low-risk, Gleason pattern 3 localised prostate cancer at 47 European university centres and community hospitals between 8 March 2011 and 30 April 2013. Treatment was 4 mg/kg padeliporfin intravenously over 10 minutes with optical fibres inserted into the prostate and activated by 753 nm laser light at a fixed 150 mW/cm for 22 minutes 15 seconds. Active surveillance followed best practice at the time of design: biopsy at 12-month intervals with PSA and digital rectal examination every 3 months. Median follow-up was 24 months.\n\nThe commonest grade 3 to 4 adverse events after treatment were prostatitis (three men, 2 percent, against one under surveillance), acute urinary retention (three, 2 percent, against one) and erectile dysfunction (two, 1 percent, against three). The commonest serious adverse event after treatment was urinary retention in 15 men, severe in three, resolving within 2 months in all (Lancet Oncology 2017).","NICE TA546 does not recommend padeliporfin within its marketing authorisation for untreated, unilateral, low-risk prostate cancer. The committee's stated reasoning was that long-term studies show men with low-risk disease live as long under active surveillance, that radical therapies carry long-term severe side effects, and that better diagnostics now identify low-risk disease more accurately."],"nct":"NCT01310894","phase":"3","setting":"A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance","sponsor":"Steba Biotech S.A.","result":"Disease progression at 24 months in 28 percent after padeliporfin vascular-targeted photodynamic therapy against 58 percent under active surveillance (adjusted hazard ratio 0.34, 95 percent confidence interval 0.24 to 0.46); negative biopsy at 24 months in 49 against 14 percent. NICE TA546 does not recommend the treatment in England.","started":"2011-02","yearReported":2017,"enrolled":413,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease progression at 24 months","primary":true,"unit":"%","arms":[{"name":"Padeliporfin vascular-targeted photodynamic therapy","n":206,"value":28,"note":"Adjusted hazard ratio; progression defined as histological progression from low to moderate or high risk, or death."},{"name":"Active surveillance","n":207,"value":58}],"hr":0.34,"ci":[0.24,0.46],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(16)30661-1"},{"endpoint":"Negative prostate biopsy at 24 months","primary":true,"unit":"%","arms":[{"name":"Padeliporfin vascular-targeted photodynamic therapy","n":206,"value":49,"note":"Adjusted risk ratio 3.67 (95 percent confidence interval 2.53 to 5.33)."},{"name":"Active surveillance","n":207,"value":14}],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(16)30661-1"}],"replication":"No independent randomised replication; it remains the only phase 3 comparison of a focal therapy against active surveillance in prostate cancer."},{"id":"nct03937141","kind":"trial","name":"Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer","aka":[],"tldr":"A phase 2 trial of ADU-S100 in Head and neck squamous cell carcinoma, run by Chinook Therapeutics, Inc. (formerly Aduro), recorded as terminated on the registry.","summary":"Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer is a phase 2 interventional study registered as NCT03937141 by Chinook Therapeutics, Inc. (formerly Aduro), with 16 participants recorded, started 2019-08-26 and due to reach its primary completion in 2021-05-10. Interventions recorded: ADU-S100. Conditions recorded: Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer.\n\nLinked to the drug ADU-S100 because the registry names it among its interventions and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03937141","url":"https://clinicaltrials.gov/study/NCT03937141"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":["adu-s100"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03937141","phase":"2","setting":"A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults With Head and Neck Cancer","sponsor":"Chinook Therapeutics, Inc. (formerly Aduro)","started":"2019-08-26","startedType":"actual","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07095439","kind":"trial","name":"Efficacy and Toxicity of Total Neoadjuvant Sandwich Treatment Via Short Course Radiotherapy in the Treatment of Stage II and III Rectal Cancer Patients","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Ain Shams University, now recruiting.","summary":"Efficacy and Toxicity of Total Neoadjuvant Sandwich Treatment Via Short Course Radiotherapy in the Treatment of Stage II and III Rectal Cancer Patients is a phase 2, interventional study registered as NCT07095439 by Ain Shams University, with a registry enrolment figure of 38 participants, started 2023-09-01 and due to reach its primary completion in 2026-01-01. Interventions recorded: Total Neoadjuvant Treatment. Conditions listed: Rectal Cancer. Primary outcome: Pathological complete response. Colorectal eligibility wording from the registry: \"* Pathologically confirmed rectal adenocarcinoma of low or mid rectum (less than 16 cm from the anal verge on endoscopy)\". Sites: Egypt. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07095439","url":"https://clinicaltrials.gov/study/NCT07095439"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07095439","phase":"2","setting":"Efficacy and Toxicity of Total Neoadjuvant Sandwich Treatment Via Short Course Radiotherapy in the Treatment of Stage II and III Rectal Cancer Patients","sponsor":"Ain Shams University","started":"2023-09-01","startedType":"actual","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04655976","kind":"trial","name":"Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy","aka":["COSTAR Lung"],"tldr":"A phase 2/3 trial testing Cobolimab in non-small-cell lung cancer, active and no longer recruiting.","summary":"Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy is a phase 2/3 interventional study registered as NCT04655976, led by GlaxoSmithKline, and active but no longer recruiting on the registry. Official title: A Randomised, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung). Planned enrolment is 758 participants (actual). The study started in 2020-12-08 and primary completion is expected in 2025-06-05. Results have been posted on ClinicalTrials.gov; they are not yet summarised here.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04655976","url":"https://clinicaltrials.gov/study/NCT04655976"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["tim3-blockade"],"targets":[],"drugs":["cobolimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04655976","phase":"2/3","setting":"A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)","sponsor":"GlaxoSmithKline","started":"2020-12-08","startedType":"actual","yearReported":2026,"enrolled":758,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS) (Arm A Versus Arm C)","primary":true,"unit":"months","arms":[{"name":"Cobolimab + Dostarlimab + Docetaxel (Arm A)","n":305,"value":11.9,"note":"95% CI 10.6 to 14.2; Figures from the ClinicalTrials.gov results section (first posted 2026-07-01), not from a publication"},{"name":"Docetaxel (Arm C)","n":152,"value":11.3,"note":"95% CI 9.5 to 13.9"}],"hr":0.85,"ci":[0.68,1.06],"p":"0.079708","source":"https://clinicaltrials.gov/study/NCT04655976?tab=results"},{"endpoint":"Overall Survival (OS) (Arm B Versus Arm C)","primary":true,"unit":"months","arms":[{"name":"Dostarlimab + Docetaxel (Arm B)","n":301,"value":11.8,"note":"95% CI 10.3 to 12.9; Figures from the ClinicalTrials.gov results section (first posted 2026-07-01), not from a publication"},{"name":"Docetaxel (Arm C)","n":152,"value":11.3,"note":"95% CI 9.5 to 13.9"}],"hr":0.96,"ci":[0.77,1.2],"p":"0.369509","source":"https://clinicaltrials.gov/study/NCT04655976?tab=results"},{"endpoint":"Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Cobolimab + Dostarlimab + Docetaxel (Arm A)","n":305,"value":4.4,"note":"95% CI 4.2 to 5.5; Figures from the ClinicalTrials.gov results section (first posted 2026-07-01), not from a publication"},{"name":"Dostarlimab + Docetaxel (Arm B)","n":301,"value":4.2,"note":"95% CI 4.0 to 5.4"},{"name":"Docetaxel (Arm C)","n":152,"value":4.1,"note":"95% CI 2.9 to 4.8"}],"source":"https://clinicaltrials.gov/study/NCT04655976?tab=results"},{"endpoint":"Overall Response Rate (ORR)","unit":"%","arms":[{"name":"Cobolimab + Dostarlimab + Docetaxel (Arm A)","n":305,"value":18.7,"note":"95% CI 14.5 to 23.5; Figures from the ClinicalTrials.gov results section (first posted 2026-07-01), not from a publication"},{"name":"Dostarlimab + Docetaxel (Arm B)","n":301,"value":18.3,"note":"95% CI 14.1 to 23.1"},{"name":"Docetaxel (Arm C)","n":152,"value":14.5,"note":"95% CI 9.3 to 21.1"}],"source":"https://clinicaltrials.gov/study/NCT04655976?tab=results"}]},{"id":"nct03567889","kind":"trial","name":"Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients","aka":["NeoDREAM"],"tldr":"A phase 3 trial of Daromun in melanoma, run by Philogen S.p.A., now recruiting.","summary":"Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients is a phase 3 interventional study registered as NCT03567889 by Philogen S.p.A., with 186 participants planned, started 2018-09-20 and due to reach its primary completion in 2027-12. Interventions recorded: Daromun, Surgery and Adjuvant therapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03567889","url":"https://clinicaltrials.gov/study/NCT03567889"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","stage-iii-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["daromun"],"companies":["philogen-s-p-a"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03567889","phase":"3","setting":"An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C/D Melanoma Patients","sponsor":"Philogen S.p.A.","started":"2018-09-20","startedType":"actual","enrolled":186,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05065801","kind":"trial","name":"Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients","aka":["GABRINOX2"],"tldr":"A phase 2 trial in pancreatic cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle, now recruiting.","summary":"Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients is a phase 2, randomised interventional study registered as NCT05065801 by Institut du Cancer de Montpellier - Val d'Aurelle, with a registry enrolment figure of 162 participants, started 2022-01-11 and due to reach its primary completion in 2026-12-30. Interventions recorded: GEMBRAX/FOLFIRINOX Arm A; FOLFIRINOX Arm B. Conditions listed: Metastatic Pancreatic Cancer. Primary outcome: Progression-free survival. Pancreatic eligibility wording from the registry: \"Histologically or cytologically proven metastatic pancreatic adenocarcinoma\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05065801","url":"https://clinicaltrials.gov/study/NCT05065801"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05065801","phase":"2","setting":"Randomized Phase II Trial Evaluating the Efficacy of a Sequential Treatment Gemcitabine Plus Nab-paclitaxel (Gembrax) Followed by Folfirinox Versus Folfirinox Alone in Patients Treated in First Metastatic Line Pancreatic Cancer","sponsor":"Institut du Cancer de Montpellier - Val d'Aurelle","started":"2022-01-11","startedType":"actual","enrolled":162,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04861558","kind":"trial","name":"Efficacy of Hyperthermic Intraperitoneal Chemotherapy","aka":["EFFIPEC"],"tldr":"A phase 3 trial of fOLFIRI (5-FU, leucovorin, irinotecan) and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Uppsala University, now recruiting.","summary":"Efficacy of Hyperthermic Intraperitoneal Chemotherapy is a phase 3, randomised interventional study registered as NCT04861558 by Uppsala University, with a registry enrolment figure of 213 participants, started 2021-05-01 and due to reach its primary completion in 2025-12. Interventions recorded: 5Fluorouracil; Irinotecan; Oxaliplatin. Conditions listed: Colorectal Cancer; Peritoneal Metastases. Primary outcome: Recurrence-free survival. Colorectal eligibility wording from the registry: \"Colorectal cancer with peritoneal metastases +/- liver metastases (maximum 3)\". Sites: India, Sweden. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04861558","url":"https://clinicaltrials.gov/study/NCT04861558"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","hipec","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfiri","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04861558","phase":"3","setting":"EFFIPEC - Efficacy of Hyperthermic Intraperitoneal Chemotherapy, Single-arm Phase I Study, Followed by an Open-label, Randomized, Controlled Registry-based Phase III Trial","sponsor":"Uppsala University","started":"2021-05-01","startedType":"actual","enrolled":213,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05821686","kind":"trial","name":"Efficacy of Interleukin-2 in Triple Negative Breast Cancer","aka":[],"tldr":"A phase 1/2 trial in triple-negative breast cancer, run by Nova Scotia Health Authority, not yet recruiting.","summary":"Efficacy of Interleukin-2 in Triple Negative Breast Cancer is a phase 1/2, interventional study registered as NCT05821686 by Nova Scotia Health Authority, with a registry enrolment figure of 10 participants, started 2026-01-02 and due to reach its primary completion in 2028-04. Interventions recorded: Human Interleukin-2 (IL-2) (Proleukin). Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Women with biopsy proven TNBC who are not scheduled to receive neoadjuvant chemotherapy\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05821686","url":"https://clinicaltrials.gov/study/NCT05821686"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05821686","phase":"1/2","setting":"Efficacy of Intralesional IL-2 for Resectable Triple Negative Breast Cancer","sponsor":"Nova Scotia Health Authority","started":"2026-01-02","startedType":"estimated","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07600268","kind":"trial","name":"Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Shandong Cancer Hospital and Institute, now recruiting.","summary":"Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer is a phase 2, randomised interventional study registered as NCT07600268 by Shandong Cancer Hospital and Institute, with a registry enrolment figure of 24 participants, started 2025-08-14 and due to reach its primary completion in 2028-08-14. Interventions recorded: Stereotactic Body Radiotherapy (SBRT) with maintenance therapy; Maintenance therapy. Conditions listed: Pancreatic Cancer Non-resectable. Primary outcome: 1-Year Overall Survival (OS) Rate. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed diagnosis of pancreatic - adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07600268","url":"https://clinicaltrials.gov/study/NCT07600268"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07600268","phase":"2","setting":"Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer: A Multi-center, Randomized Controlled Phase II Clinical Trial","sponsor":"Shandong Cancer Hospital and Institute","started":"2025-08-14","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03351062","kind":"trial","name":"Efficacy of Tamoxifen Versus Toremifene in CYP2D6 IM/PM of Premenopausal Patients With ER-positive Early Breast Cancer","aka":[],"tldr":"A phase 3 trial of Tamoxifen and Toremifene in Breast cancer, run by Chinese Anti-Cancer Association, with a status the registry has not verified recently.","summary":"Efficacy of Tamoxifen Versus Toremifene in CYP2D6 IM/PM of Premenopausal Patients With ER-positive Early Breast Cancer is a phase 3 interventional study registered as NCT03351062 by Chinese Anti-Cancer Association, with 844 participants planned, started 2017-11 and due to reach its primary completion in 2025-12. Interventions recorded: Tamoxifen, Toremifene. Conditions recorded: Breast Cancer Female.\n\nLinked to the drug Toremifene because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03351062","url":"https://clinicaltrials.gov/study/NCT03351062"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tamoxifen","toremifene"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03351062","phase":"3","setting":"Multicenter Prospective, Parallel-controlled Phase III Clinical Study on Comparing Efficacy of Tamoxifen Versus Toremifene in CYP2D6 Intermediate/Poor Metabolizers of Premenopausal Patients With ER-positive Early Breast Cancer","sponsor":"Chinese Anti-Cancer Association","started":"2017-11","startedType":"estimated","enrolled":844,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06783491","kind":"trial","name":"Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer","aka":["FOXHIPECT4"],"tldr":"A phase 3 trial of mitomycin C and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Maimónides Biomedical Research Institute of Córdoba, now recruiting.","summary":"Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer is a phase 3, randomised interventional study registered as NCT06783491 by Maimónides Biomedical Research Institute of Córdoba, with a registry enrolment figure of 1083 participants, started 2026-05-26 and due to reach its primary completion in 2030-06-01. Interventions recorded: Mitomycin (MM); FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin); Cytoreductive surgery. Conditions listed: Locally Advanced Colorectal Cancer. Primary outcome: Disease-free survival absolute; Disease-free survival probability. Colorectal eligibility wording from the registry: \"* Adenocarcinoma of the colon, sigmoid colon and rectum-sigmoid junction that is cT4a/b according to the American Joint Committee on Cancer (AJCC) TNM eight edition\". Sites: Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06783491","url":"https://clinicaltrials.gov/study/NCT06783491"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","hipec","platinum"],"targets":[],"drugs":["mitomycin","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06783491","phase":"3","setting":"Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer: A Phase III Multi-arm, Randomized and Controlled Clinical Trial (FOXHIPECT4)","sponsor":"Maimónides Biomedical Research Institute of Córdoba","started":"2026-05-26","startedType":"actual","enrolled":1083,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07446270","kind":"trial","name":"Efficacy of Tunlametinib in Combination With Anti-EGFR Monoclonal Antibody in Patients With RAS-Mutated Advanced Gastrointestinal Malignancies","aka":[],"tldr":"A phase 2 trial of cetuximab and nimotuzumab in pancreatic cancer, run by Chinese PLA General Hospital, not yet recruiting.","summary":"Efficacy of Tunlametinib in Combination With Anti-EGFR Monoclonal Antibody in Patients With RAS-Mutated Advanced Gastrointestinal Malignancies is a phase 2, interventional study registered as NCT07446270 by Chinese PLA General Hospital, with a registry enrolment figure of 90 participants, started 2026-03-03 and due to reach its primary completion in 2027-10-30. Interventions recorded: Colorectal cancer: Tunlametinib + cetuximab β; Pancreatic cancer: Tunlametinib + cetuximab β; Pancreatic cancer: Tunlametinib +Nimotuzumab. Conditions listed: Treatment for Advanced Colorectal Cancer; Treatment for Advanced Pancreatic Cancer. Primary outcome: ORR. Pancreatic eligibility wording from the registry: \"Patients with histologically or pathologically confirmed advanced pancreatic cancer or advanced colorectal cancer who have failed standard therapy;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07446270","url":"https://clinicaltrials.gov/study/NCT07446270"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["cetuximab","nimotuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07446270","phase":"2","setting":"A Cohort Clinical Study to Evaluate the Efficacy and Safety of Tunlametinib Combined With Anti-EGFR Monoclonal Antibody in Patients With RAS-mutated Advanced Gastrointestinal Malignancies","sponsor":"Chinese PLA General Hospital","started":"2026-03-03","startedType":"estimated","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07025850","kind":"trial","name":"Efficacy Study of Digoxin Combined With Serplulimab and Chemotherapy in First-Line Treatment of MSS Advanced Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of tislelizumab in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"Efficacy Study of Digoxin Combined With Serplulimab and Chemotherapy in First-Line Treatment of MSS Advanced Colorectal Cancer is a phase 1/2, interventional study registered as NCT07025850 by Fudan University, with a registry enrolment figure of 20 participants, started 2025-08-01 and due to reach its primary completion in 2027-01-01. Interventions recorded: Digoxin; Fuquinitinib; Tislelizumab. Conditions listed: Colorectal Carcinoma. Primary outcome: objective response rate (ORR). Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07025850","url":"https://clinicaltrials.gov/study/NCT07025850"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07025850","phase":"1/2","setting":"Phase II Clinical Study of Digoxin Combined With Fruquintinib and Tislelizumab in Patients With Advanced Primary Colorectal Cancer Who Failed Standard Therapy","sponsor":"Fudan University","started":"2025-08-01","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05364489","kind":"trial","name":"Efficacy, Safety and Exploratory Clinical Study of Bevacizumab Combined With Oxaliplatin and TAS-102 in First-line Treatment of Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of bevacizumab (glioblastoma use), fOLFOX (5-FU, leucovorin, oxaliplatin) and trifluridine/tipiracil in colorectal cancer, run by The First Affiliated Hospital of Zhengzhou University, not yet recruiting.","summary":"Efficacy, Safety and Exploratory Clinical Study of Bevacizumab Combined With Oxaliplatin and TAS-102 in First-line Treatment of Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT05364489 by The First Affiliated Hospital of Zhengzhou University, with a registry enrolment figure of 20 participants, started 2022-06-15 and due to reach its primary completion in 2025-06-15. Interventions recorded: Bevacizumab combined with Oxaliplatin and TAS-102. Conditions listed: Advanced Colorectal Cancer. Primary outcome: Progression Free Survival (PFS). Colorectal eligibility wording from the registry: \"advanced colorectal cancer patients\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05364489","url":"https://clinicaltrials.gov/study/NCT05364489"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["bevacizumab-glioma","folfox","trifluridine-tipiracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05364489","phase":"2","setting":"Efficacy, Safety and Exploratory Clinical Study of Bevacizumab Combined With Oxaliplatin and TAS-102 in First-line Treatment of Advanced Colorectal Cancer","sponsor":"The First Affiliated Hospital of Zhengzhou University","started":"2022-06-15","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01875393","kind":"trial","name":"Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Padeliporfin in Prostate cancer, run by Steba Biotech S.A., completed.","summary":"Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer is a phase 3 interventional study registered as NCT01875393 by Steba Biotech S.A., with 81 participants recorded, started 2013-05 and reaching its primary completion in 2014-12. Interventions recorded: TOOKAD® Soluble. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Padeliporfin because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01875393","url":"https://clinicaltrials.gov/study/NCT01875393"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["padeliporfin"],"companies":["steba-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01875393","phase":"3","setting":"Study of the Efficacy,Safety and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Localized Prostate Cancer","sponsor":"Steba Biotech S.A.","started":"2013-05","enrolled":81,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07698613","kind":"trial","name":"EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer","aka":["BrUOG 438"],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Brown University, not yet recruiting.","summary":"EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer is a phase 1/2, interventional study registered as NCT07698613 by Brown University, with a registry enrolment figure of 30 participants, started 2026-09 and due to reach its primary completion in 2029-03. Interventions recorded: ASP-1929 photoimmunotherapy. Conditions listed: Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection; Pancreatic Cancer Borderline; Pancreatic Cancer Resectable. Primary outcome: Incidence of treatment related toxicities grade ≥3; Number of Participants Reaching 6 Months Progression Free Survival. Pancreatic eligibility wording from the registry: \"Pathologically confirmed pancreatic adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07698613","url":"https://clinicaltrials.gov/study/NCT07698613"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac","locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07698613","phase":"1/2","setting":"BrUOG 438: EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer","sponsor":"Brown University","started":"2026-09","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06486142","kind":"trial","name":"EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study","aka":["ERIS"],"tldr":"A phase 3 trial of Afatinib, Dacomitinib and Osimertinib in Non-small-cell lung cancer, run by Region Skane, now recruiting.","summary":"EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study is a phase 3 interventional study registered as NCT06486142 by Region Skane, with 200 participants planned, started 2022-09-21 and due to reach its primary completion in 2028-09. Interventions recorded: Afatinib/Dacomitinib, Osimertinib. Conditions recorded: Non-Small Cell Lung Cancer.\n\nLinked to the drug Dacomitinib because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06486142","url":"https://clinicaltrials.gov/study/NCT06486142"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["afatinib","dacomitinib","osimertinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06486142","phase":"3","setting":"EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study","sponsor":"Region Skane","started":"2022-09-21","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07617805","kind":"trial","name":"EGFR/HER2 Dual-Target CAR-NK Cells for Recurrent or Metastatic HNSCC","aka":[],"tldr":"A phase 1/2 trial of therascreen companion diagnostic kits, Fludarabine, Cyclophosphamide in head and neck squamous cell carcinoma, run by Beijing Biotech, now recruiting.","summary":"EGFR/HER2 Dual-Target CAR-NK Cells for Recurrent or Metastatic HNSCC is a phase 1/2 interventional study registered as NCT07617805 by Beijing Biotech, with 42 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-03-14. Interventions recorded: EGFR/HER2 Dual-Target CAR-NK Cells, Fludarabine, Cyclophosphamide. Conditions listed: Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma, Biomarker-positive EGFR/HER2- Expressing HNSCC. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07617805","url":"https://clinicaltrials.gov/study/NCT07617805"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["therascreen-cdx","fludarabine","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07617805","phase":"1/2","setting":"A Phase 1/2, Open-Label, Biomarker-Enriched Study of Allogeneic EGFR/HER2 Dual-Target CAR-NK Cells Following Fludarabine/Cyclophosphamide Lymphodepletion in Adults With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07262619","kind":"trial","name":"EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Partic","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in colorectal cancer and endometrial cancer, run by Eikon Therapeutics, now recruiting.","summary":"EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors is a phase 1/2 interventional study registered as NCT07262619 by Eikon Therapeutics, with 160 participants planned, started 2026-01-20 and due to reach its primary completion in 2029-03. Interventions recorded: EIK1005, pembrolizumab (KEYTRUDA® ). Conditions listed: Advanced Solid Tumors, MSI-H or dMMR Advanced Solid Tumors, MSI-H/dMMR Gastric Cancer, MSI-H/dMMR Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07262619","url":"https://clinicaltrials.gov/study/NCT07262619"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","endometrial","msi-high-colorectal","endometrial-mmr-deficient"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","eik1005"],"companies":["eikon-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07262619","phase":"1/2","setting":"A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors, Including Checkpoint Inhibitor Naïve Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors","sponsor":"Eikon Therapeutics","started":"2026-01-20","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06525298","kind":"trial","name":"EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Olaparib and Trastuzumab deruxtecan in advanced solid tumours, run by Eisbach Bio GmbH, now recruiting.","summary":"EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors is a phase 1/2 interventional study registered as NCT06525298 by Eisbach Bio GmbH, with 144 participants planned, started 2024-09-09 and due to reach its primary completion in 2027-09. Interventions recorded: EIS-12656, Olaparib and Trastuzumab deruxtecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06525298","url":"https://clinicaltrials.gov/study/NCT06525298"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["olaparib","trastuzumab-deruxtecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06525298","phase":"1/2","setting":"A Phase 1/2, Open Label Trial to Investigate the Safety, Tolerability, and Preliminary Efficacy of EIS-12656 as Single Agent and in Combination With a Poly-ADP Ribose Polymerase (PARP) Inhibitor or Trastuzumab Deruxtecan (T-DXd), an Antibody Drug Conjugate (ADC), in Participants With Specified Solid Tumors","sponsor":"Eisbach Bio GmbH","started":"2024-09-09","startedType":"actual","enrolled":144,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05596409","kind":"trial","name":"ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study","aka":[],"tldr":"A phase 2 trial of Elacestrant in HR-positive / HER2-negative breast cancer, run by Stemline Therapeutics, Inc., active and no longer recruiting.","summary":"ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study is a phase 2 interventional study registered as NCT05596409 by Stemline Therapeutics, Inc., with 61 participants enrolled, started 2023-05-19 and due to reach its primary completion in 2026-11. Interventions recorded: Elacestrant.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05596409","url":"https://clinicaltrials.gov/study/NCT05596409"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["elacestrant"],"companies":["menarini"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05596409","phase":"2","setting":"ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer: An Open-Label Multicenter Phase 2 Study (ELCIN)","sponsor":"Stemline Therapeutics, Inc.","started":"2023-05-19","startedType":"actual","enrolled":61,"enrolledBasis":"registry","outcomes":[]},{"id":"elara","kind":"trial","name":"ELARA","aka":["Tisagenlecleucel in follicular lymphoma","ELARA trial"],"tldr":"A single infusion of a patient's own reprogrammed immune cells cleared follicular lymphoma completely in about seven out of ten people who had already been through several treatments.","summary":"Follicular lymphoma relapses repeatedly and each remission tends to be shorter than the last, so the group that has exhausted antibodies, chemotherapy and often a transplant has needed something that does not depend on chemotherapy sensitivity. ELARA is the multinational phase 2 study of tisagenlecleucel in that group.\n\nOf 98 enrolled patients, 97 received the product. In the 94-patient efficacy set, the complete response rate, the primary endpoint, was 69.1 per cent (95 per cent confidence interval 58.8 to 78.3) and the overall response rate 86.2 per cent (77.5 to 92.4), at a median follow-up of 16.6 months. Within eight weeks of infusion, cytokine release syndrome occurred in 48.5 per cent with no grade 3 or worse case, neurological events in 37.1 per cent with 3 per cent grade 3 or worse, and immune effector cell-associated neurotoxicity syndrome in 4.1 per cent. There were no treatment-related deaths.\n\nThe absence of severe cytokine release syndrome is what separates this from the aggressive-lymphoma CAR-T experience and is why the treatment can be given in centres that would not attempt it in diffuse large B-cell lymphoma. ELARA, ZUMA-5 and the bispecific antibody trials together mean that early-progressing follicular lymphoma now has three chemotherapy-free options.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT03568461","url":"https://clinicaltrials.gov/study/NCT03568461"},{"label":"Nature Medicine 2022","url":"https://doi.org/10.1038/s41591-021-01622-0"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["follicular-lymphoma","non-hodgkin-lymphoma"],"sections":["cell-therapy"],"technologies":["car-t"],"targets":["cd19"],"drugs":["tisagenlecleucel"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":["crs","icans","complete-response","lymphoma-tx-pod24","lymphoma-tx-car-t-pathway"],"trials":["zuma-5"],"people":["catherine-thieblemont","martin-dreyling"],"bottlenecks":["b-manufacturing-cell-therapy","b-global-access"],"keyPapers":["paper-elara-tisagenlecleucel-follicular-nat-med-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03568461","phase":"2","setting":"Relapsed or refractory follicular lymphoma after two or more lines, or relapsing after an autologous transplant: a single infusion of tisagenlecleucel","sponsor":"Novartis Pharmaceuticals","result":"Complete response in 69.1 per cent and overall response in 86.2 per cent, with no grade 3 or worse cytokine release syndrome and no treatment-related deaths.","started":"2018-11-12","startedType":"actual","yearReported":2022,"enrolled":97,"enrolledBasis":"treated","enrolledNote":"The registry records 98 enrolled; 97 received tisagenlecleucel and 94 formed the efficacy set.","outcomes":[{"endpoint":"Complete response rate","primary":true,"unit":"%","arms":[{"name":"Tisagenlecleucel","n":94,"value":69.1}],"ci":[58.8,78.3],"source":"https://doi.org/10.1038/s41591-021-01622-0"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Tisagenlecleucel","n":94,"value":86.2}],"ci":[77.5,92.4]}],"replication":"Concordant with ZUMA-5, which used a different CD19 product in the same population."},{"id":"elective-neck-dissection-tmh","kind":"trial","name":"Elective vs therapeutic neck dissection in node-negative oral cancer (Tata Memorial)","aka":[],"tldr":"A Tata Memorial trial ended a 50-year debate by showing that removing the neck lymph nodes at the first operation for early mouth cancer raises three-year survival from about two-thirds to four-fifths.","summary":"596 patients were enrolled and 500 analysed (245 elective, 255 therapeutic) with a median follow-up of 39 months. There were 81 recurrences and 50 deaths with elective dissection against 146 recurrences and 79 deaths with therapeutic dissection; 3-year overall survival was 80.0% versus 67.5% (hazard ratio 0.64; 95% CI 0.45-0.92; P=0.01) and disease-free survival 69.5% versus 45.9% (P<0.001), with adverse events in 6.6% versus 3.6%. Presented in the ASCO plenary and published in NEJM, it changed guidelines worldwide and showed that Indian centres, with their very large oral cancer volumes, can settle questions Western centres cannot.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT00193765","url":"https://clinicaltrials.gov/study/NCT00193765"},{"label":"D'Cruz et al., NEJM 2015","url":"https://doi.org/10.1056/NEJMoa1506007"}],"tags":[],"related":[],"cancers":["head-and-neck","oral-cavity-cancer","oral-tongue-cancer","buccal-mucosa-cancer"],"sections":[],"technologies":["sentinel-node"],"targets":[],"drugs":[],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":["os"],"trials":[],"people":["dcruz-anil"],"bottlenecks":["b-surgery-radiation-innovation"],"keyPapers":["paper-dcruz-elective-neck-dissection-nejm-2015"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00193765","phase":"3","setting":"Early-stage (T1-T2) node-negative oral squamous cell cancer: elective neck dissection at primary surgery vs watchful waiting with therapeutic dissection at nodal relapse","sponsor":"Tata Memorial Centre","result":"3-year OS 80.0% vs 67.5% (HR 0.64); DFS 69.5% vs 45.9%.","started":"2004-01","yearReported":2015,"enrolled":596,"enrolledBasis":"registered","enrolledNote":"ClinicalTrials.gov lists an estimated 710 participants and the record's status is unknown, meaning the sponsor has not verified it recently; the NEJM 2015 paper reports 596 patients enrolled between 2004 and 2014, with the first 500 analysed.","outcomes":[{"endpoint":"3-year overall survival","primary":true,"unit":"%","arms":[{"name":"Elective neck dissection","n":245,"value":80},{"name":"Therapeutic neck dissection","n":255,"value":67.5}],"hr":0.64,"ci":[0.45,0.92],"p":"0.01","source":"https://doi.org/10.1056/NEJMoa1506007"}]},{"id":"nct07034326","kind":"trial","name":"Electroacupuncture Combined With Immune Checkpoint Inhibitors as Adjuvant Therapy After Surgery for Early-stage Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2/3 trial in lung cancer, run by Kong Fanming, now recruiting.","summary":"Electroacupuncture Combined With Immune Checkpoint Inhibitors as Adjuvant Therapy After Surgery for Early-stage Non-small Cell Lung Cancer is a phase 2/3, randomised interventional study registered as NCT07034326 by Kong Fanming, with a registry enrolment figure of 405 participants, started 2025-01-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: Electroacupuncture combined with immunotherapy; Zilongjin tablet combined with immunotherapy; Immunotherapy. Conditions listed: Non-Small Cell Lung Cancer; Electroacupuncture; Immune Checkpoint Inhibitors. Primary outcome: Disease free survival(DFS). Lung eligibility wording from the registry: \"* (1) Non-tumor patients with stage II, IIIA, IIIB (N2) non-small cell lung cancer diagnosed by pathology or cytology after surgery; (2) driver mutations negative patients; (3) Postoperative adjuvant chemotherapy was received for 1 to 4 cycles;(4)conforms to two qi syndrome of traditional Chinese me\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07034326","url":"https://clinicaltrials.gov/study/NCT07034326"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07034326","phase":"2/3","setting":"Observation on the Clinical Efficacy of Electroacupuncture Combined With Immune Checkpoint Inhibitors as Adjuvant Therapy After Surgery for Early-stage Non-small Cell Lung Cancer","sponsor":"Kong Fanming","started":"2025-01-01","startedType":"actual","enrolled":405,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00744653","kind":"trial","name":"Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects","aka":[],"tldr":"A phase 2 trial of Electrochemotherapy in Breast cancer, run by Copenhagen University Hospital at Herlev, recorded as terminated on the registry.","summary":"Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects is a phase 2 interventional study registered as NCT00744653 by Copenhagen University Hospital at Herlev, with 17 participants recorded, started 2008-10 and due to reach its primary completion in 2010-11. Interventions recorded: Electrochemotherapy. Conditions recorded: Breast Cancer.\n\nLinked to the technology Electrochemotherapy because the registry names it (\"electrochemotherapy\") among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00744653","url":"https://clinicaltrials.gov/study/NCT00744653"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["electrochemotherapy","electrochemotherapy-devices"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00744653","phase":"2","setting":"Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects.","sponsor":"Copenhagen University Hospital at Herlev","started":"2008-10","yearReported":2014,"enrolled":17,"enrolledBasis":"registry","outcomes":[{"endpoint":"Clinical Measure of Lesion Size.","primary":true,"unit":"participants","arms":[{"name":"Electrochemotherapy","n":12,"value":2,"note":"Figures from the ClinicalTrials.gov results section (first posted 2014-07-18), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00744653?tab=results"},{"endpoint":"Participants With Objective Response Evaluated With PET/CT","unit":"participants","arms":[{"name":"Electrochemotherapy","n":12,"value":4,"note":"Figures from the ClinicalTrials.gov results section (first posted 2014-07-18), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00744653?tab=results"}]},{"id":"nct07443475","kind":"trial","name":"Electrochemotherapy for Recurrent Vulvar Cancer","aka":[],"tldr":"A phase 2 trial of Electrochemotherapy in Vulvar cancer, run by Institute of Oncology Ljubljana, now recruiting.","summary":"Electrochemotherapy for Recurrent Vulvar Cancer is a phase 2 interventional study registered as NCT07443475 by Institute of Oncology Ljubljana, with 13 participants planned, started 2021-09-01 and due to reach its primary completion in 2026-08-31. Interventions recorded: Electrochemotherapy (ECT). Conditions recorded: Vulvar Cancer, Recurrent Vulvar Cancer.\n\nLinked to the technology Electrochemotherapy because the registry names it (\"electrochemotherapy\") among its interventions and Vulvar cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07443475","url":"https://clinicaltrials.gov/study/NCT07443475"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["vulvar"],"sections":[],"technologies":["electrochemotherapy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07443475","phase":"2","setting":"Use of Electrochemotherapy in Women With Vulvar Cancer","sponsor":"Institute of Oncology Ljubljana","started":"2021-09-01","startedType":"actual","enrolled":13,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05395962","kind":"trial","name":"Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer","aka":[],"tldr":"A phase 2 trial of Electrochemotherapy in Vulvar cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna, now recruiting.","summary":"Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer is a phase 2 interventional study registered as NCT05395962 by IRCCS Azienda Ospedaliero-Universitaria di Bologna, with 92 participants planned, started 2022-04-08 and due to reach its primary completion in 2025-04-07. Interventions recorded: Carboplatin, Bleomycin. Conditions recorded: Vulvar Cancer.\n\nLinked to the technology Electrochemotherapy because the registry's title names it (\"electrochemotherapy\") and Vulvar cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05395962","url":"https://clinicaltrials.gov/study/NCT05395962"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["vulvar"],"sections":[],"technologies":["electrochemotherapy"],"targets":[],"drugs":["carboplatin","bleomycin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05395962","phase":"2","setting":"Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial","sponsor":"IRCCS Azienda Ospedaliero-Universitaria di Bologna","started":"2022-04-08","startedType":"actual","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"elevate-tn","kind":"trial","name":"ELEVATE-TN","aka":[],"tldr":"Six years on, most patients on acalabrutinib have still not progressed, and adding obinutuzumab also improved survival.","summary":"ELEVATE-TN, trial NCT02475097 sponsored by AstraZeneca and Acerta, published in the Lancet in 2020 with six-year results in Blood in 2025, showed that most previously untreated patients with chronic lymphocytic leukaemia on acalabrutinib have still not progressed six years on, and that adding obinutuzumab also improved survival over chemoimmunotherapy. It randomised 535 patients aged 65 or over or with comorbidities to acalabrutinib with or without obinutuzumab or to chlorambucil plus obinutuzumab, met its primary progression-free survival endpoint with the median not reached in either acalabrutinib arm, and showed a survival advantage for the combination with benefit in high-risk genetic subgroups. Whether obinutuzumab is worth adding for every patient is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02475097","url":"https://clinicaltrials.gov/study/NCT02475097"}],"tags":[],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["btk","cd20"],"drugs":["acalabrutinib","obinutuzumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["john-byrd"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02475681","phase":"3","setting":"Previously untreated CLL, age ≥65 or with comorbidities: acalabrutinib ± obinutuzumab vs chlorambucil + obinutuzumab","sponsor":"AstraZeneca / Acerta","result":"6-year median PFS not reached vs 27.8 months; OS HR 0.62 (A+O).","started":"2015-06-26","startedType":"actual","yearReported":2019,"enrolled":535,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (median, 6-year follow-up)","primary":true,"unit":"months","arms":[{"name":"Acalabrutinib + obinutuzumab","n":179,"note":"Median not reached"},{"name":"Acalabrutinib","n":179,"note":"Median not reached"},{"name":"Chlorambucil + obinutuzumab","n":177,"value":27.8}],"source":"https://ashpublications.org/blood/article/146/11/1276/536611/Acalabrutinib-obinutuzumab-improves-survival-vs"},{"endpoint":"Overall survival (A+O vs O+Clb)","arms":[{"name":"Acalabrutinib + obinutuzumab"},{"name":"Chlorambucil + obinutuzumab"}],"hr":0.62,"source":"https://doi.org/10.1016/S0140-6736(20)30262-2"}],"replication":"SEQUOIA (zanubrutinib) and RESONATE-2 (ibrutinib) show the same class effect of continuous BTK inhibition over chemoimmunotherapy in frontline."},{"id":"eliana","kind":"trial","name":"ELIANA","aka":[],"tldr":"ELIANA was the global trial behind the first CAR-T approval: a single infusion of tisagenlecleucel put four in five children and young adults with relapsed B-cell acute lymphoblastic leukaemia and no standard treatment remaining into remission, and most responders were still in remission without further therapy at the five-year update. Severe cytokine release syndrome affected almost half.","summary":"ELIANA, trial NCT02435849 sponsored by Novartis and published in the New England Journal of Medicine in 2018, was the global trial behind the first CAR-T approval: four in five children and young adults with relapsed or refractory B-cell acute lymphoblastic leukaemia and no standard treatment remaining went into remission after a single tisagenlecleucel infusion, and most responders stayed there for years. 75 patients were infused for the primary analysis (79 by the three-year update), the remission rate within three months was 81 percent with all responders MRD-negative, and the five-year update in JCO in 2023 showed durable survival in most responders without further therapy, at the cost of severe cytokine release syndrome in almost half. Whether children who relapse can be rescued with a second CAR-T is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02435849","url":"https://clinicaltrials.gov/study/NCT02435849"}],"tags":[],"related":[],"cancers":["all-leukemia","all-paediatric-relapsed"],"sections":[],"technologies":["car-t"],"targets":["cd19"],"drugs":["tisagenlecleucel"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":["crs"],"trials":[],"people":["stephan-grupp","emily-whitehead"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02435849","phase":"2","setting":"Relapsed or refractory B-ALL, patients aged 3-25: single infusion of tisagenlecleucel","sponsor":"Novartis","result":"ORR 81%; 12-month OS 76%; 5-year OS 55%.","started":"2015-04-08","startedType":"actual","yearReported":2018,"enrolled":79,"enrolledBasis":"treated","enrolledNote":"ClinicalTrials.gov lists 80 participants (actual); the JCO 2023 three-year update reports 79 infused patients and the NEJM 2018 primary analysis 75.","outcomes":[{"endpoint":"Overall remission rate within 3 months","primary":true,"unit":"%","arms":[{"name":"Tisagenlecleucel","n":75,"value":81}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1709866"},{"endpoint":"Overall survival at 12 months","unit":"%","arms":[{"name":"Tisagenlecleucel","value":76}],"source":"https://doi.org/10.1056/NEJMoa1709866"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Tisagenlecleucel","value":55}],"source":"https://ascopubs.org/doi/10.1200/JCO.22.00642"}],"replication":"ENSIGN (US) and real-world CIBMTR registry data (>500 children) reproduce ~85% CR and comparable durability."},{"id":"elm-pc-4-orteronel","kind":"trial","name":"ELM-PC 4","aka":["ELM-PC 4","C21004","orteronel in chemotherapy-naive mCRPC"],"tldr":"A cleaner version of abiraterone held the cancer back on scans for five extra months and did not make anyone live longer. It is the clearest warning in prostate cancer that scans are not survival.","summary":"ELM-PC 4 randomised 1,560 chemotherapy-naive men with progressive metastatic castration-resistant prostate cancer to orteronel 400 mg with prednisone twice daily (781) or placebo with prednisone (779), stratified by region and by radiographic disease progression at baseline.\n\nMedian radiographic progression-free survival was 13.8 months (95 percent confidence interval 13.1 to 14.9) with orteronel and 8.7 months (8.3 to 10.9) with placebo, hazard ratio 0.71 (0.63 to 0.80, p<0.0001). After a median 20.7 months, median overall survival was 31.4 months (28.6 to not estimable) against 29.5 months (27.0 to not estimable), hazard ratio 0.92 (0.79 to 1.08, p=0.31).\n\nA 5.1-month improvement in radiographic progression-free survival with no effect on survival is a very large dissociation, and it happened in a trial of 1,560 men with 611 deaths, so it is not a power problem.\n\nToxicity was worse with orteronel: grade 3 or worse increased lipase in 137 of 784 men (17 percent) against 14 of 770 (2 percent), increased amylase in 77 (10 percent) against nine (1 percent), fatigue in 50 (6 percent) against 14 (2 percent) and pulmonary embolism in 40 (5 percent) against 27 (4 percent). Serious adverse events occurred in 358 (46 percent) against 292 (38 percent). Takeda stopped development in this indication on these and the ELM-PC 5 data.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01193244","url":"https://clinicaltrials.gov/study/NCT01193244"},{"label":"ELM-PC 4 (Lancet Oncology 2015)","url":"https://doi.org/10.1016/S1470-2045(15)70027-6"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":["cyp17a1"],"drugs":["orteronel","prednisone"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":["arpi","castration-resistance"],"trials":["cou-aa-302","tasquinimod-10tasq10"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01193244","phase":"3","setting":"Progressive metastatic castration-resistant prostate cancer with no previous chemotherapy: orteronel 400 mg with prednisone 5 mg twice daily against placebo with prednisone, with two primary endpoints, radiographic progression-free survival and overall survival","sponsor":"Millennium Pharmaceuticals, a subsidiary of Takeda","result":"Median radiographic progression-free survival 13.8 against 8.7 months (hazard ratio 0.71, 95 percent confidence interval 0.63 to 0.80, p<0.0001) but overall survival 31.4 against 29.5 months (0.92, 0.79 to 1.08, p=0.31); development stopped.","started":"2010-10-01","startedType":"actual","yearReported":2015,"enrolled":1560,"enrolledBasis":"randomised","enrolledNote":"2,353 men were assessed for eligibility between 31 October 2010 and 29 June 2012 and 1,560 were randomised at 324 study centres in 43 countries.","outcomes":[{"endpoint":"Radiographic progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Orteronel with prednisone","n":781,"value":13.8},{"name":"Placebo with prednisone","n":779,"value":8.7}],"hr":0.71,"ci":[0.63,0.8],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(15)70027-6"},{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Orteronel with prednisone","n":781,"value":31.4},{"name":"Placebo with prednisone","n":779,"value":29.5}],"hr":0.92,"ci":[0.79,1.08],"p":"0.31","source":"https://doi.org/10.1016/S1470-2045(15)70027-6"}],"replication":"ELM-PC 5, the companion trial in men after docetaxel, also missed overall survival; 10TASQ10 with tasquinimod produced the same dissociation between radiographic progression-free survival and survival."},{"id":"nct04241315","kind":"trial","name":"ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting","aka":["ELUCIDATE"],"tldr":"A phase 3 trial of Pafolacianine in Lung cancer, run by On Target Laboratories, LLC, completed.","summary":"ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting is a phase 3 interventional study registered as NCT04241315 by On Target Laboratories, LLC, with 112 participants recorded, started 2020-03-26 and reaching its primary completion in 2021-10-07. Interventions recorded: OTL38 for Injection, Near infrared camera imaging system. Conditions recorded: Lung Neoplasms, Lung Cancer.\n\nLinked to the drug Pafolacianine because the registry names it among its interventions and Lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04241315","url":"https://clinicaltrials.gov/study/NCT04241315"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pafolacianine"],"companies":["on-target-laboratories"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04241315","phase":"3","setting":"A Phase 3, Randomized,Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules","sponsor":"On Target Laboratories, LLC","started":"2020-03-26","startedType":"actual","enrolled":112,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06550141","kind":"trial","name":"Emapalumab Prevention of CAR-T Cell Associated Toxicities","aka":[],"tldr":"A phase 2 trial of Emapalumab, Cyclophosphamide, Fludarabine and Axicabtagene ciloleucel in Non-Hodgkin lymphoma, Diffuse large B-cell lymphoma, Primary mediastinal and Follicular lymphoma, run by Marcela V. Maus, M.D.,Ph.D., now recruiting.","summary":"Emapalumab Prevention of CAR-T Cell Associated Toxicities is a phase 2 interventional study registered as NCT06550141 by Marcela V. Maus, M.D.,Ph.D., with 28 participants planned, started 2024-09-18 and due to reach its primary completion in 2026-08-01. Interventions recorded: Emapalumab, Cyclophosphamide, Fludarabine Phosphate, Axicabtagene Ciloleucel. Conditions recorded: Large B-cell Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B-cell Lymphoma, High-grade B-cell Lymphoma, Follicular Lymphoma.\n\nLinked to the drug Emapalumab because the registry names it among its interventions and Non-Hodgkin lymphoma, Diffuse large B-cell lymphoma, Primary mediastinal and Follicular lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06550141","url":"https://clinicaltrials.gov/study/NCT06550141"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","dlbcl","primary-mediastinal-b-cell-lymphoma","follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["emapalumab","cyclophosphamide","fludarabine","axicabtagene-ciloleucel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06550141","phase":"2","setting":"A Phase 2 Trial of Emapalumab for the Prevention of CAR-T Cell Associated Toxicities","sponsor":"Marcela V. Maus, M.D.,Ph.D.","started":"2024-09-18","startedType":"actual","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07567014","kind":"trial","name":"Emapalumab Prophylaxis of Bispecific T-Cell Engagers (BiTEs) Associated CRS and ICANS","aka":["BiTEs"],"tldr":"A phase 2 trial of Emapalumab in Multiple myeloma, run by NYU Langone Health, not yet recruiting.","summary":"Emapalumab Prophylaxis of Bispecific T-Cell Engagers (BiTEs) Associated CRS and ICANS is a phase 2 interventional study registered as NCT07567014 by NYU Langone Health, with 60 participants planned, started 2026-05-11 and due to reach its primary completion in 2028-05-31. Interventions recorded: Emapalumab. Conditions recorded: Multiple Myeloma, Large B-cell Lymphoma (LBCL).\n\nLinked to the drug Emapalumab because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07567014","url":"https://clinicaltrials.gov/study/NCT07567014"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["emapalumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07567014","phase":"2","setting":"A Phase II Study of the Interferon Gamma Inhibitor Emapalumab for Prophylaxis of Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity Syndrome in Patients With Lymphoma and Multiple Myeloma Receiving Bispecific T-Cell Engagers","sponsor":"NYU Langone Health","started":"2026-05-11","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"embark","kind":"trial","name":"EMBARK","aka":[],"tldr":"Showed that treating a fast-rising PSA after surgery or radiation with enzalutamide delays spread.","summary":"EMBARK, trial NCT02319837 sponsored by Pfizer and Astellas and reported in 2023, showed that treating a fast-rising PSA after surgery or radiotherapy with enzalutamide delays the appearance of metastases. It randomised 1,068 men with high-risk biochemical recurrence, defined by a PSA doubling time of nine months or less, to enzalutamide plus leuprolide, enzalutamide alone or leuprolide alone, suspending treatment if the PSA became undetectable at 36 weeks, and met its primary metastasis-free survival endpoint for the combination; approval followed in November 2023 and a survival benefit for the combination was reported in 2025. OnCo links it to prostate cancer, enzalutamide and the biochemical recurrence term. Whether treating a rising PSA early beats waiting for imaging-detected disease, now that PSMA PET finds it sooner, is the open question.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT02319837","url":"https://clinicaltrials.gov/study/NCT02319837"},{"label":"NICE TA580: enzalutamide for hormone-relapsed non-metastatic prostate cancer, not recommended","url":"https://www.nice.org.uk/guidance/ta580"}],"tags":[],"related":[],"cancers":["prostate","prostate-bcr"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["enzalutamide"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":["biochemical-recurrence","prostate-uk-drug-approvals","metastasis-free-survival","psa-doubling-time"],"trials":["radicals-hd","getug-afu-16","stomp-oligorecurrence"],"people":[],"bottlenecks":[],"keyPapers":["paper-embark-nejm-2023"],"journals":[],"dependsOn":[],"notes":["EMBARK sits between the localised and metastatic settings: high-risk biochemical recurrence after local treatment, defined by a PSA doubling time of 9 months or less, with no metastases on conventional imaging. There is no NICE technology appraisal covering enzalutamide in this indication in England, and NICE TA580, the nearest appraisal in a non-metastatic hormone-relapsed population, does not recommend enzalutamide."],"nct":"NCT02319837","phase":"3","setting":"High-risk biochemical recurrence (PSA doubling time ≤9 months) after local therapy: enzalutamide + leuprolide, enzalutamide alone, or leuprolide alone","sponsor":"Pfizer / Astellas","result":"MFS HR 0.42 (combination).","started":"2014-12-17","startedType":"actual","yearReported":2023,"enrolled":1068,"enrolledBasis":"registry","outcomes":[{"endpoint":"Metastasis-free survival, enzalutamide + leuprolide vs leuprolide","primary":true,"unit":"%","arms":[{"name":"Enzalutamide + leuprolide, 5-year MFS","n":355,"value":87.3},{"name":"Leuprolide alone, 5-year MFS","n":358,"value":71.4}],"hr":0.42,"ci":[0.3,0.61],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2303974"}],"replication":"Single pivotal trial in high-risk biochemical recurrence; OS immature."},{"id":"ember-3","kind":"trial","name":"EMBER-3","aka":[],"tldr":"An oral SERD that works alone in ESR1-mutant tumours and, combined with abemaciclib, doubles progression-free time in everyone regardless of mutation.","summary":"Three arms (imlunestrant n=331; standard ET n=330; imlunestrant + abemaciclib n=213). In ESR1-mutant tumours imlunestrant alone: PFS 5.5 vs 3.8 months (HR 0.62). Imlunestrant + abemaciclib vs imlunestrant: PFS 9.4 vs 5.5 months (HR 0.57; updated 10.9 vs 5.5, HR 0.59), with benefit irrespective of ESR1 status. Updated analysis (SABCS 2025): ESR1-mutant OS 34.5 vs 23.1 months for monotherapy vs standard ET. FDA approved imlunestrant (Inluriyo) 25 September 2025 for ESR1-mutant disease.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04975308","url":"https://clinicaltrials.gov/study/NCT04975308"},{"label":"Lilly approval release","url":"https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-inluriyo-imlunestrant-adults-er-her2-esr1"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["endocrine-therapy"],"targets":["estrogen-receptor","cdk4-6"],"drugs":["imlunestrant","abemaciclib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":["esr1-mutation","oral-serd"],"trials":[],"people":["komal-jhaveri"],"bottlenecks":[],"keyPapers":["paper-ember-3-n-engl-j-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04975308","phase":"3","setting":"ER+/HER2- advanced breast cancer after ≥1 endocrine line: imlunestrant vs standard endocrine therapy, and imlunestrant + abemaciclib vs imlunestrant","sponsor":"Eli Lilly","result":"PFS HR 0.62 (ESR1-mutant, monotherapy); HR 0.57 (combination vs monotherapy).","started":"2021-10-04","startedType":"actual","yearReported":2024,"enrolled":874,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival, ESR1-mutant (imlunestrant vs standard ET)","primary":true,"unit":"months","arms":[{"name":"Imlunestrant","value":5.5},{"name":"Standard endocrine therapy","value":3.8}],"hr":0.62,"ci":[0.46,0.82],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2410858"},{"endpoint":"Progression-free survival (imlunestrant + abemaciclib vs imlunestrant)","primary":true,"unit":"months","arms":[{"name":"Imlunestrant + abemaciclib","n":213,"value":10.9},{"name":"Imlunestrant","n":213,"value":5.5}],"hr":0.59,"ci":[0.46,0.75],"p":"<0.001","source":"https://www.annalsofoncology.org/article/S0923-7534(25)06289-1/fulltext"},{"endpoint":"Overall survival, ESR1-mutant (imlunestrant vs standard ET), updated","unit":"months","arms":[{"name":"Imlunestrant","value":34.5},{"name":"Standard endocrine therapy","value":23.1}],"source":"https://www.mskcc.org/clinical-updates/sabcs-2025-news-updated-ember-3-efficacy-results-for-imlunestrant-with-or-without-abemaciclib-in-er-her2-advanced-breast"}],"replication":"Monotherapy effect consistent with EMERALD and VERITAC-2; the combination result is the first randomised evidence for oral SERD + CDK4/6 after prior CDK4/6 exposure."},{"id":"embraca","kind":"trial","name":"EMBRACA","aka":[],"tldr":"EMBRACA showed that the PARP inhibitor talazoparib delays progression by about three months compared with chemotherapy in women with an inherited BRCA mutation and advanced breast cancer, with better quality of life but no gain in overall survival.","summary":"EMBRACA, trial NCT01945775 sponsored by Pfizer through Medivation and published in the New England Journal of Medicine in 2018, randomised 431 patients with a germline BRCA1 or BRCA2 mutation and HER2-negative advanced breast cancer to talazoparib once daily or the physician's choice of capecitabine, eribulin, gemcitabine or vinorelbine. Progression-free survival rose from 5.6 to 8.6 months (hazard ratio 0.54), the response rate more than doubled and patient-reported quality of life deteriorated later on talazoparib, while anaemia needing transfusion was more common. The final overall survival analysis in 2020 showed no significant difference (hazard ratio 0.85), which the authors attributed partly to later PARP inhibitor and platinum use in the control arm. It led to the October 2018 approval of talazoparib and, with OlympiAD, established PARP inhibitors as an alternative to chemotherapy in BRCA carriers. Whether combining PARP inhibition with immunotherapy or antibody-drug conjugates adds to it is the open question.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01945775","url":"https://clinicaltrials.gov/study/NCT01945775"},{"label":"Litton et al., EMBRACA (NEJM 2018)","url":"https://doi.org/10.1056/NEJMoa1802905"},{"label":"NICE TA952 (21 February 2024)","url":"https://www.nice.org.uk/guidance/ta952"},{"label":"Talzenna label (openFDA): EMBRACA study section","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22TALZENNA%22"}],"tags":[],"related":[],"cancers":["tnbc","breast-hr-positive","tnbc-metastatic","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["parp-inhibitor"],"targets":["brca","parp"],"drugs":["talazoparib","capecitabine","eribulin","gemcitabine","vinorelbine"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":["gbrca-mutation"],"trials":[],"people":["jennifer-litton"],"bottlenecks":[],"keyPapers":["paper-embraca-n-engl-j-med-2018"],"journals":[],"dependsOn":[],"notes":["Triple-negative disease was 44 percent of EMBRACA and a stratification factor (Talzenna label). Final overall survival (Annals of Oncology 2020): hazard ratio 0.85, medians 19.3 versus 19.5 months; 46.3 versus 41.7 percent later received platinum and 4.5 versus 32.6 percent a PARP inhibitor. Six UK sites. England: NICE TA952 (21 February 2024)."],"nct":"NCT01945775","phase":"3","setting":"Germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer: talazoparib vs physician's choice chemotherapy","sponsor":"Pfizer (Medivation)","result":"PFS 8.6 vs 5.6 months, HR 0.54; OS HR 0.85, not significant.","started":"2013-10-14","startedType":"actual","yearReported":2018,"enrolled":431,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Talazoparib","n":287,"value":8.6},{"name":"Chemotherapy","n":144,"value":5.6}],"hr":0.54,"ci":[0.41,0.71],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1802905"},{"endpoint":"Overall survival (final)","arms":[{"name":"Talazoparib"},{"name":"Chemotherapy"}],"hr":0.85,"ci":[0.67,1.07],"source":"https://doi.org/10.1016/j.annonc.2020.08.2098"}],"replication":"Consistent with OlympiAD; neither PARP inhibitor trial showed an overall survival gain."},{"id":"emerald","kind":"trial","name":"EMERALD","aka":[],"tldr":"The first oral oestrogen-receptor degrader to beat standard hormone therapy, with the benefit concentrated in tumours carrying ESR1 mutations.","summary":"EMERALD, trial NCT03778931 sponsored by Radius and Menarini and reported in 2021, was the first trial in which an oral oestrogen receptor degrader beat standard hormone therapy, with the benefit concentrated in tumours carrying ESR1 mutations. It randomised 478 women with ER-positive, HER2-negative advanced breast cancer after one or two endocrine lines including a CDK4/6 inhibitor to elacestrant or standard endocrine therapy, met its primary progression-free survival endpoints in the whole population and the ESR1-mutant group, with a larger effect in the mutant group that grew with longer prior CDK4/6 exposure, and led to approval in January 2023 for ESR1-mutant disease with a ctDNA companion diagnostic. The ESR1-restricted benefit was replicated by EMBER-3 and VERITAC-2, and whether oral SERDs help without the mutation remains open.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03778931","url":"https://clinicaltrials.gov/study/NCT03778931"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["endocrine-therapy"],"targets":["estrogen-receptor"],"drugs":["elacestrant"],"companies":[],"institutions":[],"pathways":[],"terms":["esr1-mutation"],"trials":[],"people":["francois-clement-bidard","aditya-bardia"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03778931","phase":"3","setting":"ER+/HER2- advanced breast cancer after 1-2 endocrine lines including a CDK4/6 inhibitor: elacestrant vs standard endocrine therapy","sponsor":"Radius / Menarini","result":"PFS HR 0.55 in ESR1-mutant.","started":"2019-05-10","startedType":"actual","yearReported":2021,"enrolled":478,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (ESR1-mutant)","primary":true,"unit":"months","arms":[{"name":"Elacestrant","n":115,"value":3.8},{"name":"Standard endocrine therapy","n":113,"value":1.9}],"hr":0.55,"ci":[0.39,0.77],"p":"0.0005","source":"https://ascopubs.org/doi/10.1200/JCO.22.00338"},{"endpoint":"Progression-free survival (all patients)","primary":true,"unit":"months","arms":[{"name":"Elacestrant","n":239,"value":2.8},{"name":"Standard endocrine therapy","n":239,"value":1.9}],"hr":0.7,"ci":[0.55,0.88],"p":"0.002","source":"https://doi.org/10.1200/JCO.22.00338"}],"replication":"The ESR1-mutant-restricted benefit was replicated by imlunestrant (EMBER-3) and vepdegestrant (VERITAC-2)."},{"id":"emerald-1","kind":"trial","name":"EMERALD-1","aka":[],"tldr":"The first trial to show that adding immunotherapy and an anti-VEGF drug to TACE delays progression in intermediate-stage liver cancer.","summary":"EMERALD-1, trial NCT03778957 sponsored by AstraZeneca and reported in 2024, was the first trial to show that adding immunotherapy and an anti-VEGF drug to transarterial chemoembolisation delays progression in intermediate-stage hepatocellular carcinoma. It randomised 616 embolisation-eligible patients to TACE with durvalumab, with or without bevacizumab, or TACE with placebo, met its primary progression-free survival endpoint for the three-way combination, and overall survival trended favourably but was not statistically significant at follow-up, as published in the Lancet in 2025. OnCo links it to TACE as a technology and term, durvalumab and the pairing of TACE with immunotherapy and anti-VEGF drugs. Whether delaying progression after TACE translates into longer life is the open question, and LEAP-012 suggests it may not.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03778957","url":"https://clinicaltrials.gov/study/NCT03778957"},{"label":"Lancet","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02551-0/abstract"}],"tags":[],"related":[],"cancers":["hcc","hcc-intermediate"],"sections":[],"technologies":["tace"],"targets":[],"drugs":["durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["tace-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03778957","phase":"3","setting":"Embolisation-eligible unresectable HCC: TACE + durvalumab ± bevacizumab vs TACE + placebo","sponsor":"AstraZeneca","result":"PFS HR 0.77; OS HR 0.80, not significant.","started":"2018-11-30","startedType":"actual","yearReported":2024,"enrolled":616,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 724 participants (actual); the Lancet 2025 paper reports 887 patients screened and 616 randomised (204, 207 and 205 across the three arms).","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"TACE + durvalumab + bevacizumab","value":15},{"name":"TACE + placebo","value":8.2}],"hr":0.77,"ci":[0.61,0.98]},{"endpoint":"Overall survival","arms":[{"name":"TACE + durvalumab + bevacizumab"},{"name":"TACE + placebo"}],"hr":0.8,"ci":[0.57,1.11]}]},{"id":"emerald-3","kind":"trial","name":"EMERALD-3","aka":[],"tldr":"In 2026 a dual-immunotherapy regimen plus lenvatinib added to TACE cut the risk of progression by about 30%; whether it extends life is not yet known.","summary":"EMERALD-3, trial NCT05301842 sponsored by AstraZeneca and reported at ASCO 2026, showed that the dual immunotherapy STRIDE regimen of durvalumab and tremelimumab plus lenvatinib added to transarterial chemoembolisation cut the risk of progression by about thirty percent in embolisation-eligible unresectable hepatocellular carcinoma. It randomised 725 patients and met its primary progression-free survival endpoint at an interim analysis, with overall survival trending favourably but not formally tested, making it the third TACE combination trial positive for progression after EMERALD-1 and LEAP-012. OnCo links it to TACE, durvalumab, tremelimumab, lenvatinib and the TACE plus immunotherapy pairing. Whether it extends life, where LEAP-012 did not, is the question that will decide its place.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05301842","url":"https://clinicaltrials.gov/study/NCT05301842"},{"label":"ASCO Post","url":"https://ascopost.com/issues/july-25-2026/emerald-3-shows-benefit-with-stride-plus-tace-in-hepatocellular-carcinoma/"}],"tags":[],"related":["src-asco-post"],"cancers":["hcc","hcc-intermediate"],"sections":[],"technologies":["tace"],"targets":[],"drugs":["durvalumab","tremelimumab","lenvatinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05301842","phase":"3","setting":"Embolisation-eligible unresectable HCC: STRIDE (durvalumab + tremelimumab) + lenvatinib + TACE vs TACE","sponsor":"AstraZeneca","result":"PFS HR ~0.70 (interim); OS immature.","started":"2022-03-28","startedType":"actual","yearReported":2026,"enrolled":760,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"arms":[{"name":"STRIDE + lenvatinib + TACE"},{"name":"TACE"}],"hr":0.7,"source":"https://www.astrazeneca.com/media-centre/press-releases/2026/imfinzi-plus-imjudo-combined-with-lenvatinib-and-tace-reduced-the-risk-of-disease-progression-or-death-in-emerald-3-phase-iii-trial.html"}]},{"id":"empower-cervical-1","kind":"trial","name":"EMPOWER-Cervical 1 / GOG-3016 / ENGOT-cx9","aka":[],"tldr":"The first immunotherapy to extend life in recurrent cervical cancer, approved in Europe but declined by the FDA.","summary":"EMPOWER-Cervical 1, also GOG-3016 and ENGOT-cx9, trial NCT03257267 sponsored by Regeneron and Sanofi and published in the New England Journal of Medicine in 2022, produced the first immunotherapy to extend life in recurrent cervical cancer after first-line platinum, approved in Europe but declined by the FDA. It randomised 608 patients to cemiplimab or single-agent chemotherapy and met its primary overall survival endpoint regardless of PD-L1 status or histology; the European Union approved it in 2022, but the FDA issued a complete response letter in January 2022 over inspection issues and the application was not resubmitted. OnCo links it to cervical cancer, PD-1 as a target, cemiplimab, Regeneron and Sanofi. It has been largely superseded by first-line chemo-immunotherapy, and whether single-agent PD-1 blockade retains a second-line role after that is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03257267","url":"https://clinicaltrials.gov/study/NCT03257267"},{"label":"NEJM 2022","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2112187"}],"tags":[],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["cemiplimab"],"companies":["regeneron","sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03257267","phase":"3","setting":"Recurrent cervical cancer after first-line platinum: cemiplimab vs single-agent chemotherapy","sponsor":"Regeneron / Sanofi","result":"OS 12.0 vs 8.5 months (HR 0.69).","started":"2017-09-05","startedType":"actual","yearReported":2021,"enrolled":608,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Cemiplimab","n":304,"value":12},{"name":"Chemotherapy","n":304,"value":8.5}],"hr":0.69,"ci":[0.56,0.84],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2112187"}]},{"id":"empower-cscc-1","kind":"trial","name":"EMPOWER-CSCC-1","aka":[],"tldr":"EMPOWER-CSCC-1 showed that cemiplimab shrinks almost half of advanced skin squamous cell cancers, most of them for years, and it gave this cancer its first approved drug.","summary":"EMPOWER-CSCC-1 was a single-arm phase 2 trial of the PD-1 antibody cemiplimab in cutaneous squamous cell carcinoma that was metastatic or locally advanced and beyond cure with surgery or radiotherapy. Cutaneous squamous cell carcinoma carries one of the highest mutation burdens of any cancer because of ultraviolet damage, and it is commoner in immunosuppressed people, both of which pointed to immunotherapy.\n\nIn the first report (NEJM 2018) the objective response rate in the metastatic group was 47 percent, and in the pooled analysis of 193 patients across the three groups (2021) it was 46 percent with complete responses in 16 percent; the median duration of response had not been reached. Toxicity was that of PD-1 blockade generally.\n\nCemiplimab was approved for advanced cutaneous squamous cell carcinoma in September 2018, the first systemic therapy for the disease, and the trial opened the way to pembrolizumab (KEYNOTE-629), cosibelimab, neoadjuvant cemiplimab and the adjuvant C-POST trial.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02760498","url":"https://clinicaltrials.gov/study/NCT02760498"},{"label":"NEJM 2018","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1805131"},{"label":"Pooled analysis, JITC 2021","url":"https://doi.org/10.1136/jitc-2020-002757"}],"tags":[],"related":[],"cancers":["advanced-cutaneous-scc","cutaneous-scc","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["cemiplimab"],"companies":["regeneron","sanofi"],"institutions":[],"pathways":[],"terms":["tmb","skin-cancer-after-organ-transplant","radiotherapy-for-skin-cancer"],"trials":["c-post","neoadjuvant-cemiplimab-cscc","trog-05-01","cemiplimab-kidney-transplant-cscc"],"people":[],"bottlenecks":[],"keyPapers":["paper-empower-cscc-1-lancet-oncol-2020","paper-empower-cscc-1-j-am-acad-dermatol-2025-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02760498","phase":"2","setting":"Locally advanced or metastatic cutaneous squamous cell carcinoma not suitable for curative surgery or radiotherapy: cemiplimab in three dose groups","sponsor":"Regeneron / Sanofi","result":"Objective response 47% in the metastatic group; 46% in the pooled analysis of 193 patients with 16% complete responses.","started":"2016-04-07","startedType":"actual","yearReported":2018,"enrolled":193,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (metastatic group)","primary":true,"unit":"%","arms":[{"name":"Cemiplimab","n":59,"value":47}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1805131"},{"endpoint":"Objective response rate (pooled analysis)","unit":"%","arms":[{"name":"Cemiplimab","n":193,"value":46}],"source":"https://doi.org/10.1136/jitc-2020-002757"}],"replication":"KEYNOTE-629 (pembrolizumab) and the cosibelimab pivotal study found response rates of the same order with other PD-1 pathway antibodies."},{"id":"empower-lung-1","kind":"trial","name":"EMPOWER-Lung 1","aka":[],"tldr":"EMPOWER-Lung 1 showed that cemiplimab, a third PD-1 antibody, lengthens life compared with chemotherapy in lung cancers with high PD-L1, reproducing the pembrolizumab result with a different drug.","summary":"EMPOWER-Lung 1 randomised 710 patients with untreated advanced non-small-cell lung cancer to cemiplimab or platinum doublet chemotherapy; the primary population was the 563 patients whose tumours had confirmed PD-L1 expression of 50 percent or more. Patients on chemotherapy could cross over to cemiplimab at progression, and patients on cemiplimab could add chemotherapy.\n\nIn the PD-L1-high population median overall survival was not reached with cemiplimab against 14.2 months with chemotherapy (hazard ratio 0.57), and median progression-free survival was 8.2 against 5.7 months (hazard ratio 0.54). In the three-year update median overall survival was 26.1 months against 13.3 months, with the hazard ratio unchanged despite crossover.\n\nThe FDA approved cemiplimab for this indication in February 2021, and a companion trial, EMPOWER-Lung 3, later added cemiplimab to chemotherapy regardless of PD-L1.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03088540","url":"https://clinicaltrials.gov/study/NCT03088540"},{"label":"The Lancet 2021","url":"https://doi.org/10.1016/S0140-6736(21)00228-2"},{"label":"Lancet Oncology 2023 (three-year update)","url":"https://doi.org/10.1016/S1470-2045(23)00329-7"}],"tags":[],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","pdl1"],"drugs":["cemiplimab","carboplatin","cisplatin","paclitaxel","pemetrexed"],"companies":["regeneron","sanofi"],"institutions":[],"pathways":["pd1-checkpoint"],"terms":["tps","pd-l1-testing"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-empower-lung-1-lancet-2021","paper-empower-lung-1-lancet-oncol-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03088540","phase":"3","setting":"Untreated advanced non-small-cell lung cancer with PD-L1 of 50 percent or more and no EGFR, ALK or ROS1 alteration: cemiplimab versus platinum doublet chemotherapy, with crossover at progression","sponsor":"Regeneron / Sanofi","result":"Median overall survival not reached vs 14.2 months (hazard ratio 0.57) in PD-L1 50% or more; 26.1 vs 13.3 months in the three-year update; median progression-free survival 8.2 vs 5.7 months.","started":"2017-05-29","startedType":"actual","yearReported":2021,"enrolled":710,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, PD-L1 50% or more (three-year update)","primary":true,"unit":"months","arms":[{"name":"Cemiplimab","n":283,"value":26.1},{"name":"Platinum chemotherapy","n":280,"value":13.3}],"hr":0.57,"source":"https://doi.org/10.1016/S1470-2045(23)00329-7"},{"endpoint":"Progression-free survival, PD-L1 50% or more","primary":true,"unit":"months","arms":[{"name":"Cemiplimab","n":283,"value":8.2},{"name":"Platinum chemotherapy","n":280,"value":5.7}],"hr":0.54,"source":"https://doi.org/10.1016/S0140-6736(21)00228-2"}],"replication":"Reproduces KEYNOTE-024 (pembrolizumab) and IMpower110 (atezolizumab) in the same PD-L1-high population."},{"id":"nct04205227","kind":"trial","name":"ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in melanoma, run by ENB Therapeutics, Inc, active and no longer recruiting.","summary":"ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors is a phase 1/2 interventional study registered as NCT04205227 by ENB Therapeutics, Inc, with 137 participants planned, started 2020-02-18 and due to reach its primary completion in 2026-01-01. Interventions recorded: ENB003, Pembrolizumab. Conditions listed: Cancer, Melanoma, Ovary Cancer, Pancreatic Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04205227","url":"https://clinicaltrials.gov/study/NCT04205227"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","enb003"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04205227","phase":"1/2","setting":"A Phase 1/2A Trial of ENB 003 in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors","sponsor":"ENB Therapeutics, Inc","started":"2020-02-18","startedType":"actual","enrolled":137,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06640166","kind":"trial","name":"Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafen","aka":["ECLYPse"],"tldr":"A phase 2 trial in colorectal cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS, now recruiting.","summary":"Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab. is a phase 2, interventional study registered as NCT06640166 by Fondazione Policlinico Universitario Agostino Gemelli IRCCS, with a registry enrolment figure of 25 participants, started 2024-06-03 and due to reach its primary completion in 2025-12-31. Interventions recorded: encorafenib + cetuximab + FOLFIRI. Conditions listed: Colorectal Carcinoma; Colorectal Neoplasms; Colorectal Tumor; Colorectal Adenocarcinoma; Colorectal Cancer (CRC); Colorectal Cancer; Colon Cancer; Colon Adenocarcinoma; Colon Carcinoma; Colon Neoplasm. Primary outcome: 6-month Progression Free Survival rate. Colorectal eligibility wording from the registry: \"* histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma;\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06640166","url":"https://clinicaltrials.gov/study/NCT06640166"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer","braf-v600e-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["pierre-fabre"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06640166","phase":"2","setting":"Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab.","sponsor":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","started":"2024-06-03","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05706779","kind":"trial","name":"Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer","aka":["NEORAF"],"tldr":"A phase 2 trial of cetuximab in colorectal cancer, run by Federation Francophone de Cancerologie Digestive, now recruiting.","summary":"Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer is a phase 2, interventional study registered as NCT05706779 by Federation Francophone de Cancerologie Digestive, with a registry enrolment figure of 30 participants, started 2023-02-13 and due to reach its primary completion in 2026-12-30. Interventions recorded: Encorafenib Oral Capsule + Cetuximab. Conditions listed: Colorectal Cancer; BRAF V600E Mutation Positive. Primary outcome: To assess the rate of significant tumour regression (TRG 0 to 2 according to Ryan's modified score of the AJCC 2010). Colorectal eligibility wording from the registry: \"* Adenocarcinoma of the colon or of the upper rectum (supra-peritoneal) considered operable and histologically confirmed, localised, mutated BRAF V600E determined in a biopsy specimen and resectable after CT-scan assessment\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05706779","url":"https://clinicaltrials.gov/study/NCT05706779"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","braf-v600e-colorectal"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["cetuximab"],"companies":["pierre-fabre"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05706779","phase":"2","setting":"Combination of Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With Braf v600e-mutates Localised Colon or Upper Rectum Cancer (Neoraf Study)","sponsor":"Federation Francophone de Cancerologie Digestive","started":"2023-02-13","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06940947","kind":"trial","name":"Endoscopic Therapy Or Surgery for Early Colon Cancer","aka":["ETHOS"],"tldr":"A phase 3 trial in colorectal cancer, run by Norwegian Department of Health and Social Affairs, now recruiting.","summary":"Endoscopic Therapy Or Surgery for Early Colon Cancer is a phase 3, randomised interventional study registered as NCT06940947 by Norwegian Department of Health and Social Affairs, with a registry enrolment figure of 434 participants, started 2025-08-25 and due to reach its primary completion in 2033-09-01. Interventions recorded: eFTR; Surgery. Conditions listed: Colon Cancer. Primary outcome: Rate of severe adverse events, re-admissions and deaths within 30 days; Rate of cancer recurrence or CRC death after three years. Colorectal eligibility wording from the registry: \"* Newly diagnosed biopsy-confirmed colon cancer (adenocarcinoma) with macroscopic suspicion of submucosal invasion considered removable by EFTR as deemed by the local multidisciplinary team (MDT) at the participating center\". Sites: Poland. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06940947","url":"https://clinicaltrials.gov/study/NCT06940947"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06940947","phase":"3","setting":"Endoscopic THerapy Or Surgery for Early Colon Cancer (ETHOS)","sponsor":"Norwegian Department of Health and Social Affairs","started":"2025-08-25","startedType":"actual","enrolled":434,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06831136","kind":"trial","name":"Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma","aka":["PANCARDINAL-2"],"tldr":"A phase 2 trial in pancreatic cancer, run by The University of Texas Health Science Center, Houston, now recruiting.","summary":"Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma is a phase 2, interventional study registered as NCT06831136 by The University of Texas Health Science Center, Houston, with a registry enrolment figure of 24 participants, started 2025-03-26 and due to reach its primary completion in 2028-01-20. Interventions recorded: Neoadjuvant Chemotherapy (NAC); Immunotherapy (pembrolizumab); Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA). Conditions listed: Pancreatic Ductal Adenocarcinoma. Primary outcome: Efficacy as assessed by the Overall response rate using RECIST v1.1 guidelines. Pancreatic eligibility wording from the registry: \"Patients who have undergone prior resection will be excluded unless there is recurrent pancreatic tumor that is amenable to EUS-RFA\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06831136","url":"https://clinicaltrials.gov/study/NCT06831136"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06831136","phase":"2","setting":"Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma; a Phase II Trial PANcreas CAncer RaDIofrequeNcy AbLation","sponsor":"The University of Texas Health Science Center, Houston","started":"2025-03-26","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07429643","kind":"trial","name":"Endoscopic Ultrasound-Guided Loco-regional Chemotherapy Injection as Adjuvant Therapy for Locally Advanced Pancreatic Cancer.","aka":[],"tldr":"A phase 2/3 trial in pancreatic cancer, run by Assiut University, not yet recruiting.","summary":"Endoscopic Ultrasound-Guided Loco-regional Chemotherapy Injection as Adjuvant Therapy for Locally Advanced Pancreatic Cancer. is a phase 2/3, randomised interventional study registered as NCT07429643 by Assiut University, with a registry enrolment figure of 20 participants, started 2026-04-15 and due to reach its primary completion in 2028-12-15. Interventions recorded: endoscopic ultrasonograhy guided chemptherapy injection. Conditions listed: Locally Advanced Pancreatic Cancer. Primary outcome: compare patients with locally advanced pancreatic cancer treated with EUS guided injection of gemcitabine plus systemic chemotherapy to those treated with the standard systemic chemotherapy alone, regarding to(progression -freesurvival and response rate). Pancreatic eligibility wording from the registry: \"* Patients recently diagnosed to have pancreatic adenocarcinoma based on histopathological examination\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07429643","url":"https://clinicaltrials.gov/study/NCT07429643"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac","locally-advanced-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07429643","phase":"2/3","setting":"Endoscopic Ultrasound-Guided Loco-regional Chemotherapy Injection as Adjuvant Therapy for Locally Advanced Pancreatic Cancer: A Randomized Controlled Trial.","sponsor":"Assiut University","started":"2026-04-15","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02971345","kind":"trial","name":"Endovascular Brachytherapy Combined With Stent Placement and TACE for HCC With Main Portal Vein Tumor Thrombus","aka":[],"tldr":"A phase 3 trial of Epirubicin and Ethiodized oil in Hepatocellular carcinoma, run by Shanghai Zhongshan Hospital, with a status the registry has not verified recently.","summary":"Endovascular Brachytherapy Combined With Stent Placement and TACE for HCC With Main Portal Vein Tumor Thrombus is a phase 3 interventional study registered as NCT02971345 by Shanghai Zhongshan Hospital, with 253 participants planned, started 2017-01 and due to reach its primary completion in 2020-10. Interventions recorded: Stent and Iodine-125 seed strand implantation, Stent, Iodine-125 seed, Epirubicin, Ultra-fluid lipiodol, Gelatin sponge articles. Conditions recorded: Hepatocellular Carcinoma, Portal Vein Tumor Thrombus.\n\nLinked to the drug Ethiodized oil because the registry names it among its interventions and Hepatocellular carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02971345","url":"https://clinicaltrials.gov/study/NCT02971345"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-intermediate"],"sections":[],"technologies":[],"targets":[],"drugs":["epirubicin","ethiodized-oil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02971345","phase":"3","setting":"Endovascular Brachytherapy Combined With Stent Placement and Transcatheter Arterial Chemoembolization (TACE) for Treatment of HCC With Main Portal Vein Tumor Thrombus Versus TACE Alone: a Prospective Randomized Controlled Multicentre Trial","sponsor":"Shanghai Zhongshan Hospital","started":"2017-01","enrolled":253,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07566156","kind":"trial","name":"Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)","aka":[],"tldr":"A phase 3 trial of Enfortumab vedotin, Cisplatin, Mitomycin C, Gemcitabine and Pembrolizumab in bladder & urothelial cancer, run by Astellas Pharma Global Development, Inc., now recruiting.","summary":"Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309) is a phase 3 interventional study registered as NCT07566156 by Astellas Pharma Global Development, Inc., with 390 participants planned, started 2026-05-11 and due to reach its primary completion in 2030-03-31. Interventions recorded: Enfortumab vedotin, Conventional Radiotherapy, Hypofractionated Radiotherapy, Cisplatin, Fluorouracil and Mitomycin C.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07566156","url":"https://clinicaltrials.gov/study/NCT07566156"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["enfortumab-vedotin","cisplatin","mitomycin","gemcitabine","pembrolizumab"],"companies":["astellas","pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07566156","phase":"3","setting":"A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE ENFORTUMAB VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB IN ADULT PARTICIPANTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY","sponsor":"Astellas Pharma Global Development, Inc.","started":"2026-05-11","startedType":"actual","enrolled":390,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06120140","kind":"trial","name":"Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib","aka":["COCOON"],"tldr":"A phase 2 trial of Amivantamab and Lazertinib in non-small-cell lung cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib is a phase 2 interventional study registered as NCT06120140 by Janssen Research & Development, LLC, with 305 participants enrolled, started 2024-02-16 and due to reach its primary completion in 2027-05-31. Interventions recorded: Amivantamab IV, Amivantamab SC, Lazertinib, Doxycycline, Minocycline and Clindamycin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06120140","url":"https://clinicaltrials.gov/study/NCT06120140"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["bispecific-antibody","kinase-inhibitors"],"targets":[],"drugs":["amivantamab","lazertinib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct06120140-j-thorac-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06120140","phase":"2","setting":"A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivantamab + Lazertinib","sponsor":"Janssen Research & Development, LLC","started":"2024-02-16","startedType":"actual","enrolled":305,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07698106","kind":"trial","name":"Enhancing ICB Efficacy Through IL-1 Inhibition in TNBC","aka":[],"tldr":"A phase 1/2 trial in triple-negative breast cancer, run by University Health Network, Toronto, not yet recruiting.","summary":"Enhancing ICB Efficacy Through IL-1 Inhibition in TNBC is a phase 1/2, randomised interventional study registered as NCT07698106 by University Health Network, Toronto, with a registry enrolment figure of 60 participants, started 2026-08 and due to reach its primary completion in 2034-08. Interventions recorded: Group 1-Isunakinra. Conditions listed: Triple-Negative Breast Cancer (TNBC). Triple-negative eligibility wording from the registry: \"Newly diagnosed, locally advanced, previously untreated and centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, and staging per current AJCC staging criteria for breast cancer as assessed by the inves\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07698106","url":"https://clinicaltrials.gov/study/NCT07698106"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07698106","phase":"1/2","setting":"Rebooting Sensitivity to Checkpoint Blockade Therapy in Triple-Negative Breast Cancer With Isunakinra (RESETT- I)","sponsor":"University Health Network, Toronto","started":"2026-08","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"enliven","kind":"trial","name":"ENLIVEN","aka":[],"tldr":"The CSF1R blocker pexidartinib shrank tenosynovial giant cell tumours in about four in ten patients against none on placebo, becoming the first approved drug for this joint tumour, with a liver-safety programme attached.","summary":"ENLIVEN randomised 120 patients with symptomatic, advanced tenosynovial giant cell tumour in whom surgery would cause worsening functional limitation or severe morbidity to pexidartinib or placebo for 24 weeks. The RECIST response rate at week 25 was 39 percent with pexidartinib versus none with placebo, with improvements in range of motion and function; mixed or cholestatic liver injury in a minority of patients led to a risk evaluation and mitigation strategy at FDA approval in August 2019. Published in the Lancet in 2019, it was the first randomised trial to show benefit of a drug in this disease and set the template for vimseltinib (MOTION) and emactuzumab.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02371369","url":"https://clinicaltrials.gov/study/NCT02371369"},{"label":"Lancet 2019","url":"https://doi.org/10.1016/S0140-6736(19)30764-0"}],"tags":["subtype-page"],"related":[],"cancers":["tenosynovial-giant-cell-tumour","sarcoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["csf1r"],"drugs":["pexidartinib"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-tap-lancet"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02371369","phase":"3","setting":"Symptomatic tenosynovial giant cell tumour not amenable to surgery: pexidartinib versus placebo","sponsor":"Daiichi Sankyo (Plexxikon)","result":"Week 25 RECIST response 39% vs 0% (placebo); FDA approval 2019 with a liver-toxicity REMS.","started":"2015-05-11","startedType":"actual","yearReported":2019,"enrolled":120,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response at week 25 (RECIST)","primary":true,"unit":"percent","arms":[{"name":"Pexidartinib","n":61,"value":39},{"name":"Placebo","n":59,"value":0}],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(19)30764-0"}]},{"id":"enrich","kind":"trial","name":"ENRICH","aka":["Ibrutinib and rituximab versus immunochemotherapy in mantle cell lymphoma","ENRICH trial","EudraCT 2015-000832-13"],"tldr":"A British and Nordic trial took chemotherapy out of first-line treatment for older people with mantle cell lymphoma and found the two-drug, chemotherapy-free combination worked better.","summary":"ENRICH is the first randomised trial in untreated mantle cell lymphoma to show that a chemotherapy-free first line beats immunochemotherapy. It ran at 66 sites in the United Kingdom, Sweden, Norway, Finland and Denmark, and randomised 397 patients aged 60 or over with stage II to IV disease and performance status 0 to 2 between ibrutinib 560 mg daily with rituximab, and rituximab with the investigator's pre-chosen chemotherapy, either R-CHOP or bendamustine. All responders received two years of rituximab maintenance every eight weeks; the ibrutinib group continued ibrutinib until progression.\n\nAt a median follow-up of 47.9 months, progression-free survival favoured ibrutinib-rituximab with an adjusted hazard ratio of 0.69 (95 per cent confidence interval 0.52 to 0.90, p = 0.0034). The subgroup split is the interesting part: against R-CHOP the hazard ratio was 0.37 (0.22 to 0.62), against bendamustine-rituximab 0.91 (0.66 to 1.25). Grade 3 or above adverse events were reported by 67 per cent of the ibrutinib-rituximab group and 70 per cent of the immunochemotherapy group.\n\nThe practical reading is that the chemotherapy-free option is clearly better than R-CHOP and roughly equivalent to bendamustine-rituximab, which is why it is an option rather than a replacement. The median age was 74 and three-quarters of participants were male, which matches the epidemiology of the disease.","status":"positive","asOf":"2026-10-01","links":[{"label":"Lancet 2025","url":"https://doi.org/10.1016/S0140-6736(25)01432-1"},{"label":"EU Clinical Trials Register 2015-000832-13","url":"https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-000832-13"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["mantle-cell-lymphoma","non-hodgkin-lymphoma"],"sections":["targeted-therapy","chemotherapy"],"technologies":[],"targets":["btk","cd20","ccnd1"],"drugs":["ibrutinib","rituximab","bendamustine","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":[],"institutions":["cruk"],"pathways":["bcr-signalling"],"terms":["r-chop","maintenance-therapy"],"trials":["shine","triangle"],"people":[],"bottlenecks":["b-toxicity-qol","b-aging-comorbidity"],"keyPapers":["paper-enrich-ibrutinib-rituximab-mantle-cell-lancet-2025"],"journals":[],"dependsOn":[],"notes":[],"phase":"2/3","setting":"Aged 60 or over with untreated stage II to IV mantle cell lymphoma: ibrutinib with rituximab against rituximab with R-CHOP or bendamustine","sponsor":"Cancer Research UK and Johnson and Johnson Pharmaceuticals","result":"Progression-free survival adjusted hazard ratio 0.69 (p = 0.0034) for ibrutinib with rituximab against immunochemotherapy, driven by the comparison against R-CHOP (0.37) rather than against bendamustine-rituximab (0.91).","started":"2016-02","yearReported":2025,"enrolled":397,"enrolledBasis":"randomised","enrolledNote":"ENRICH has no ClinicalTrials.gov record; it was registered with EudraCT as 2015-000832-13, and the figure is the number randomised in the Lancet report.","outcomes":[{"endpoint":"Progression-free survival","primary":true,"arms":[{"name":"Ibrutinib with rituximab","n":199},{"name":"Rituximab with R-CHOP or bendamustine","n":198}],"hr":0.69,"ci":[0.52,0.9],"p":"0.0034","source":"https://doi.org/10.1016/S0140-6736(25)01432-1"},{"endpoint":"Progression-free survival, R-CHOP stratum","arms":[{"name":"Ibrutinib with rituximab"},{"name":"R-CHOP","n":53}],"hr":0.37,"ci":[0.22,0.62]},{"endpoint":"Progression-free survival, bendamustine-rituximab stratum","arms":[{"name":"Ibrutinib with rituximab"},{"name":"Bendamustine with rituximab","n":145}],"hr":0.91,"ci":[0.66,1.25]}],"replication":"The first randomised test of this question; SHINE and ECHO tested the opposite strategy of adding the inhibitor to chemotherapy."},{"id":"enthuse-m1-zibotentan","kind":"trial","name":"ENTHUSE M1","aka":["ENTHUSE M1","ENTHUSE 14","ZD4054 in bone-metastatic CRPC"],"tldr":"A drug blocking the endothelin signal that prostate cancer uses in bone did not extend life, and it caused swelling, headaches and heart failure.","summary":"ENTHUSE M1 randomised 594 men with castration-resistant prostate cancer and bone metastases, pain-free or mildly symptomatic, 1:1 to zibotentan 10 mg daily or placebo added to standard treatment.\n\nMedian overall survival was 24.5 months with zibotentan and 22.5 months with placebo, hazard ratio 0.87 (95.2 percent confidence interval 0.69 to 1.10, p=0.240). No statistically significant difference was observed for any secondary efficacy endpoint, which included time to pain progression, time to chemotherapy, and time to new bone metastases.\n\nPeripheral oedema (44 percent) and headache (31 percent) were the commonest adverse events with zibotentan, both direct consequences of endothelin A blockade. Cardiac failure of any grade occurred in 5.7 percent against 1.7 percent, and of grade 3 or worse in 3.0 against 1.0 percent, described as manageable and reversible.\n\nThe other two ENTHUSE trials, zibotentan with docetaxel and zibotentan in non-metastatic disease, were also negative, and AstraZeneca discontinued the programme in prostate cancer.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00554229","url":"https://clinicaltrials.gov/study/NCT00554229"},{"label":"ENTHUSE M1 (Cancer 2012)","url":"https://doi.org/10.1002/cncr.27674"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":["ednra"],"drugs":["zibotentan"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["bone-metastases","castration-resistance"],"trials":["swog-s0421-atrasentan"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00554229","phase":"3","setting":"Castration-resistant prostate cancer with bone metastases in men who were pain-free or mildly symptomatic: zibotentan 10 mg daily or placebo added to standard prostate cancer treatment, with overall survival as the primary endpoint","sponsor":"AstraZeneca","result":"Median overall survival 24.5 against 22.5 months (hazard ratio 0.87, 95.2 percent confidence interval 0.69 to 1.10, p=0.240): not significant, with peripheral oedema in 44 percent and cardiac failure of any grade in 5.7 against 1.7 percent.","started":"2007-11","yearReported":2012,"enrolled":594,"enrolledBasis":"randomised","enrolledNote":"594 men were randomised 1:1, 299 to zibotentan and 295 to placebo.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Zibotentan 10 mg daily","n":299,"value":24.5,"note":"Confidence interval is 95.2 percent, as reported."},{"name":"Placebo","n":295,"value":22.5}],"hr":0.87,"ci":[0.69,1.1],"p":"0.240","source":"https://doi.org/10.1002/cncr.27674"},{"endpoint":"Cardiac failure, any grade","unit":"%","arms":[{"name":"Zibotentan 10 mg daily","n":299,"value":5.7},{"name":"Placebo","n":295,"value":1.7}],"source":"https://doi.org/10.1002/cncr.27674"}],"replication":"SWOG S0421 found the same for atrasentan with docetaxel in 994 men."},{"id":"nct04891198","kind":"trial","name":"ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 2 trial of Envafolimab in advanced solid tumours, run by 3D Medicines (Sichuan) Co., Ltd., now recruiting.","summary":"ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors is a phase 2 interventional study registered as NCT04891198 by 3D Medicines (Sichuan) Co., Ltd., with 126 participants planned, started 2021-08-06 and due to reach its primary completion in 2027-08-30. Interventions recorded: Envafolimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04891198","url":"https://clinicaltrials.gov/study/NCT04891198"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["envafolimab"],"companies":["3d-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04891198","phase":"2","setting":"An Open, Single-arm, Multi-center Phase II Clinical Study of ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors","sponsor":"3D Medicines (Sichuan) Co., Ltd.","started":"2021-08-06","startedType":"actual","enrolled":126,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07003815","kind":"trial","name":"Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of envafolimab, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by Tongji Hospital, not yet recruiting.","summary":"Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT07003815 by Tongji Hospital, with a registry enrolment figure of 62 participants, started 2025-06 and due to reach its primary completion in 2026-12. Interventions recorded: Envafolimab + Gemcitabine + Cisplatin + Simvastatin. Conditions listed: Biliary Tract Cancer, Advanced Cancer. Gallbladder cancer is named in the registry entry: \"* Diagnosis : Histologically confirmed unresectable, locally advanced, or metastatic biliary tract adenocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer).\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07003815","url":"https://clinicaltrials.gov/study/NCT07003815"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["envafolimab","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07003815","phase":"2","setting":"A Single-Arm, Exploratory Clinical Study of Envafolimab Combined With Gemcitabine, Cisplatin, and Simvastatin for the Treatment of Locally Advanced or Metastatic BTC Patients","sponsor":"Tongji Hospital","started":"2025-06","startedType":"estimated","enrolled":62,"enrolledBasis":"registry","outcomes":[]},{"id":"enzamet","kind":"trial","name":"ENZAMET","aka":["ANZUP 1304"],"tldr":"ENZAMET showed that adding enzalutamide to hormone therapy from the moment prostate cancer is found to have spread helped men live longer, and it did so in an academic trial that also allowed chemotherapy, which made its results widely applicable.","summary":"ENZAMET, run by the Australian and New Zealand ANZUP group with the Canadian Cancer Trials Group and others, randomised 1125 men with metastatic hormone-sensitive prostate cancer to testosterone suppression with enzalutamide or with a conventional non-steroidal antiandrogen (bicalutamide, nilutamide or flutamide). Early docetaxel was permitted at the investigator's discretion and stratified for. The primary endpoint was overall survival.\n\nEnzalutamide improved overall survival, with the benefit clearest in men who did not receive docetaxel and in low-volume disease, and the advantage persisted in the long-term analysis. Alongside ARCHES, TITAN, LATITUDE and STAMPEDE it made intensified hormone therapy the standard for newly metastatic disease.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02446405","url":"https://clinicaltrials.gov/study/NCT02446405"},{"label":"NICE TA712: enzalutamide for treating hormone-sensitive metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta712"}],"tags":["subtype-trials"],"related":[],"cancers":["prostate-mhspc","prostate"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["enzalutamide","docetaxel"],"companies":["astellas","pfizer"],"institutions":[],"pathways":[],"terms":["prostate-uk-drug-approvals"],"trials":["arches","nct02489318"],"people":["ian-davis"],"bottlenecks":[],"keyPapers":["paper-enzamet-n-engl-j-med-2019"],"journals":[],"dependsOn":[],"notes":["In England NICE TA712 recommends enzalutamide with androgen deprivation within its marketing authorisation for hormone-sensitive metastatic prostate cancer, subject to the commercial arrangement, with no restriction to men who cannot have docetaxel. The committee's stated reasoning was that enzalutamide is taken by mouth and so more convenient than intravenous docetaxel, that it lengthens the time until progression and how long people live compared with androgen deprivation alone, and that an indirect comparison suggests longer time to progression than docetaxel plus androgen deprivation although the survival comparison is unclear."],"nct":"NCT02446405","phase":"3","setting":"Metastatic hormone-sensitive prostate cancer: testosterone suppression with enzalutamide against testosterone suppression with a standard non-steroidal antiandrogen, with docetaxel allowed in both arms","sponsor":"University of Sydney (ANZUP Cancer Trials Group)","result":"Enzalutamide added to testosterone suppression improved overall survival compared with a standard non-steroidal antiandrogen.","started":"2014-03","yearReported":2019,"enrolled":1125,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 3 years (Kaplan-Meier)","primary":true,"unit":"%","arms":[{"name":"Enzalutamide + testosterone suppression","value":80,"note":"102 vs 143 deaths; median follow-up 34 months; 1125 randomised"},{"name":"Standard nonsteroidal antiandrogen + testosterone suppression","value":72}],"hr":0.67,"ci":[0.52,0.86],"p":"0.002","source":"https://doi.org/10.1056/nejmoa1903835"},{"endpoint":"PSA progression-free survival","arms":[{"name":"Enzalutamide + testosterone suppression","note":"174 events"},{"name":"Standard nonsteroidal antiandrogen + testosterone suppression","note":"333 events"}],"hr":0.39,"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1903835"},{"endpoint":"Clinical progression-free survival","arms":[{"name":"Enzalutamide + testosterone suppression","note":"167 events"},{"name":"Standard nonsteroidal antiandrogen + testosterone suppression","note":"320 events"}],"hr":0.4,"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1903835"},{"endpoint":"Seizures","unit":"%","arms":[{"name":"Enzalutamide + testosterone suppression","value":1,"note":"7 patients"},{"name":"Standard nonsteroidal antiandrogen + testosterone suppression","value":0}],"source":"https://doi.org/10.1056/nejmoa1903835"}]},{"id":"slotman-pci-es-sclc","kind":"trial","name":"EORTC 08993 (Slotman): prophylactic cranial irradiation in extensive-stage small-cell lung cancer","aka":[],"tldr":"Slotman's trial showed that irradiating the brain before metastases appear cuts symptomatic brain metastases and lengthens survival in extensive-stage small-cell lung cancer, though a later Japanese trial with MRI screening did not confirm the survival gain.","summary":"EORTC 08993 randomised 286 patients with extensive-stage small-cell lung cancer who had responded to chemotherapy to prophylactic cranial irradiation or observation. Symptomatic brain metastases within a year fell from 40.4 to 14.6 percent and one-year survival rose from 13.3 to 27.1 percent (Slotman and colleagues, New England Journal of Medicine 2007). Patients were not required to have brain imaging before entry; Takahashi's 2017 trial with MRI surveillance found no survival benefit, so practice now varies.","status":"positive","asOf":"2026-09-17","links":[{"label":"NEJM 2007","url":"https://doi.org/10.1056/NEJMoa071780"}],"tags":["radiation-wave4"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["prophylactic-cranial-irradiation"],"targets":[],"drugs":[],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["wbrt"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-slotman-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Extensive-stage small-cell lung cancer responding to chemotherapy: prophylactic cranial irradiation versus observation","sponsor":"EORTC","result":"Symptomatic brain metastases at 1 year 14.6% vs 40.4%; 1-year survival 27.1% vs 13.3%.","yearReported":2007,"enrolled":286,"enrolledBasis":"registry","outcomes":[{"endpoint":"Symptomatic brain metastases within 1 year","primary":true,"unit":"%","arms":[{"name":"Prophylactic cranial irradiation","n":143,"value":14.6},{"name":"Observation","n":143,"value":40.4}]}]},{"id":"eortc-10801","kind":"trial","name":"EORTC 10801","aka":["EORTC breast conservation trial"],"tldr":"The third of the big conservation trials, and the one that deliberately included larger tumours. After twenty-two years there was still no difference in how long women lived, which is why keeping the breast became standard rather than optional.","summary":"EORTC 10801 recruited between 1980 and 1986 in eight centres in the United Kingdom, the Netherlands, Belgium and South Africa, and included tumours up to 5 cm, larger than Milan I allowed. 448 patients were randomised to breast-conserving therapy and 420 to modified radical mastectomy. The primary endpoint was time to distant metastasis.\n\nAfter a median follow-up of 22.1 years, 175 patients (42 percent) in the mastectomy arm and 207 (46 percent) in the conservation arm had distant metastases, and 506 patients (58 percent) had died. Neither difference was significant: the hazard ratio for time to distant metastasis was 1.13 (95 percent confidence interval 0.92 to 1.38, p=0.23) and for time to death 1.11 (0.94 to 1.33, p=0.23). Twenty-year overall survival was 44.5 percent after mastectomy and 39.1 percent after conservation, and the trial reports these as not significantly different. There was no interaction with age.\n\nThe record is marked mixed rather than positive because the point estimates favour mastectomy on both endpoints while the confidence intervals include no difference, and because the earlier reports found better local control after mastectomy. What the trial establishes is that conservation costs nothing in survival, not that the two operations are identical.","status":"mixed","asOf":"2026-09-25","links":[{"label":"EORTC 10801 twenty-year follow-up (Lancet Oncology 2012)","url":"https://doi.org/10.1016/S1470-2045(12)70042-6"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["lumpectomy","mastectomy","breast-conserving-surgery-versus-mastectomy","tumour-bed-boost","lymphadenectomy"],"trials":["nsabp-b06","milan-i"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Stage I and II breast cancer up to 5 cm, node-negative or node-positive: breast-conserving therapy with lumpectomy, complete axillary clearance, breast radiotherapy and a tumour-bed boost, against modified radical mastectomy, with time to distant metastasis as the primary endpoint","sponsor":"European Organisation for Research and Treatment of Cancer","result":"At a median 22.1 years, time to distant metastasis hazard ratio 1.13 (0.92 to 1.38) and time to death 1.11 (0.94 to 1.33) for conservation against mastectomy; twenty-year overall survival 39.1 against 44.5 percent, not significantly different.","yearReported":2012,"enrolled":868,"enrolledBasis":"randomised","enrolledNote":"868 patients were randomised between 1980 and 1986 (448 to conservation, 420 to mastectomy); the trial predates the registries, so there is no registry figure.","outcomes":[{"endpoint":"Time to distant metastasis","primary":true,"unit":"hazard ratio","arms":[{"name":"Breast-conserving therapy","n":448},{"name":"Modified radical mastectomy","n":420}],"hr":1.13,"ci":[0.92,1.38],"p":"0.23","source":"https://doi.org/10.1016/S1470-2045(12)70042-6"},{"endpoint":"Overall survival at 20 years","unit":"%","arms":[{"name":"Breast-conserving therapy","n":448,"value":39.1,"note":"95 percent confidence interval 34.4 to 43.9"},{"name":"Modified radical mastectomy","n":420,"value":44.5,"note":"95 percent confidence interval 39.3 to 49.5"}],"hr":1.11,"ci":[0.94,1.33],"p":"0.23","source":"https://doi.org/10.1016/S1470-2045(12)70042-6"}],"replication":"NSABP B-06 and Milan I reached the same conclusion on survival, with twenty-year follow-up in both."},{"id":"eortc-1607-pembro-cisgem","kind":"trial","name":"EORTC 1607: pembrolizumab with cisplatin and gemcitabine in biliary tract cancer","aka":["EORTC-1607"],"tldr":"A 50-patient European single-arm study that added pembrolizumab to standard chemotherapy for bile duct and gallbladder cancer at sites including three in England, run before the large KEYNOTE-966 trial reported.","summary":"EORTC 1607 (NCT03260712) was an open-label single-arm phase 2 of cisplatin and gemcitabine combined with pembrolizumab as first-line treatment for advanced or metastatic biliary tract carcinoma, intrahepatic or extrahepatic, or gallbladder cancer. The primary endpoint was the progression-free survival rate at six months by RECIST 1.1. Fifty patients were enrolled at seven sites in Germany, Spain and the United Kingdom between January 2020 and April 2023, and the study completed in August 2023. Results were not found in Europe PMC in September 2026; the randomised KEYNOTE-966 trial has since established the combination's survival benefit.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03260712","url":"https://clinicaltrials.gov/study/NCT03260712"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pembrolizumab","gemcitabine-cisplatin","gemcitabine","cisplatin"],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (3, registry): University College Hospital (London), The Christie (Manchester), Nottingham City Hospital."],"nct":"NCT03260712","phase":"2","setting":"First-line advanced or metastatic biliary tract cancer including gallbladder cancer: cisplatin and gemcitabine with pembrolizumab, single arm, primary endpoint 6-month progression-free survival rate","sponsor":"European Organisation for Research and Treatment of Cancer","started":"2020-01-07","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"eortc-22033","kind":"trial","name":"EORTC 22033-26033","aka":[],"tldr":"EORTC 22033 asked whether temozolomide could replace radiotherapy as the first treatment for high-risk low-grade glioma and found no difference in progression-free survival, with the molecular subtype mattering more than the choice of treatment.","summary":"EORTC 22033-26033 randomised 477 adults with high-risk low-grade glioma to 50.4 Gy radiotherapy or dose-dense temozolomide for up to a year. Median progression-free survival was 46 months with radiotherapy and 39 months with temozolomide (hazard ratio 1.16, not significant); IDH-mutant tumours without 1p/19q co-deletion did better with radiotherapy, and health-related quality of life did not differ (Baumert and colleagues, Lancet Oncology 2016). Radiotherapy followed by chemotherapy (as in RTOG 9802) remains the standard.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00182819","url":"https://clinicaltrials.gov/study/NCT00182819"},{"label":"Lancet Oncology 2016","url":"https://doi.org/10.1016/S1470-2045(16)30313-8"}],"tags":["radiation-wave4"],"related":[],"cancers":["glioblastoma","brain-tumours","idh-mutant-astrocytoma","oligodendroglioma"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["temozolomide"],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-baumert-lancet-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00182819","phase":"3","setting":"High-risk low-grade glioma: radiotherapy versus temozolomide alone as first treatment","sponsor":"EORTC","result":"Median progression-free survival 46 (radiotherapy) vs 39 months (temozolomide), no significant difference.","started":"2005-07","yearReported":2016,"enrolled":477,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Radiotherapy (50.4 Gy)","n":240,"value":46},{"name":"Dose-dense temozolomide","n":237,"value":39}],"hr":1.16,"ci":[0.9,1.5],"p":"0.22","source":"https://doi.org/10.1016/S1470-2045(16)30313-8"}]},{"id":"eortc-22863","kind":"trial","name":"EORTC 22863","aka":["EORTC 22863","Bolla trial"],"tldr":"The trial that proved hormone therapy should be added to radiotherapy for aggressive prostate cancer, and that the addition roughly halves the chance of dying of it.","summary":"EORTC 22863 randomised 415 men with prostate cancer at high metastatic risk to radiotherapy alone or to radiotherapy with immediate androgen suppression. Radiotherapy was 50 Gy to the whole pelvis over 5 weeks with a 20 Gy boost to the prostate and seminal vesicles. Goserelin 3.6 mg was given every 4 weeks for 3 years starting on the first day of irradiation, with cyproterone acetate for the first month.\n\nAt a median 9.1 years, 10-year clinical disease-free survival was 47.7 percent (95 percent confidence interval 39.0 to 56.0) with combined treatment against 22.7 percent (16.3 to 29.7) with radiotherapy alone, hazard ratio 0.42 (0.33 to 0.55, p<0.0001). Ten-year overall survival was 58.1 percent (49.2 to 66.0) against 39.8 percent (31.9 to 47.5), hazard ratio 0.60 (0.45 to 0.80, p=0.0004), and 10-year prostate cancer mortality 10.3 percent (5.1 to 15.4) against 30.4 percent (23.2 to 37.5), hazard ratio 0.38 (0.24 to 0.60, p<0.0001).\n\nThe fear that long hormone therapy would kill men through their hearts was not borne out here: cardiovascular deaths did not differ significantly, whether or not men had cardiovascular problems at entry. Two fractures were reported in the combined arm. That reassurance has limits, because the trial is small and old, and modern evidence for bone and metabolic harm from long androgen deprivation is much stronger.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00849082","url":"https://clinicaltrials.gov/study/NCT00849082"},{"label":"EORTC 22863 at 10 years (Lancet Oncology 2010)","url":"https://doi.org/10.1016/S1470-2045(10)70223-0"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation","imrt-igrt"],"targets":[],"drugs":["goserelin"],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["adt","curative-intent","hormone-therapy"],"trials":["eortc-22961","rtog-9202","spcg-7"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00849082","phase":"3","setting":"Prostate cancer at high risk of metastasis, T1 to T2 with WHO grade 3 or any T3 to T4: external beam radiotherapy alone against radiotherapy with 3 years of goserelin started on the first day of irradiation, with clinical disease-free survival as the primary endpoint","sponsor":"European Organisation for Research and Treatment of Cancer","result":"Ten-year overall survival 58.1 against 39.8 percent (hazard ratio 0.60, 95 percent confidence interval 0.45 to 0.80) and prostate cancer mortality 10.3 against 30.4 percent (0.38, 0.24 to 0.60) when 3 years of goserelin was added to radiotherapy.","started":"1987-05","yearReported":2010,"enrolled":415,"enrolledBasis":"randomised","enrolledNote":"415 men were randomised between May 1987 and October 1995 and all were included in the analysis.","outcomes":[{"endpoint":"Clinical disease-free survival at 10 years","primary":true,"unit":"%","arms":[{"name":"Radiotherapy with 3 years of goserelin","n":207,"value":47.7},{"name":"Radiotherapy alone","n":208,"value":22.7}],"hr":0.42,"ci":[0.33,0.55],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(10)70223-0"},{"endpoint":"Overall survival at 10 years","unit":"%","arms":[{"name":"Radiotherapy with 3 years of goserelin","n":207,"value":58.1},{"name":"Radiotherapy alone","n":208,"value":39.8}],"hr":0.6,"ci":[0.45,0.8],"p":"0.0004","source":"https://doi.org/10.1016/S1470-2045(10)70223-0"},{"endpoint":"Prostate cancer mortality at 10 years","unit":"%","arms":[{"name":"Radiotherapy with 3 years of goserelin","n":207,"value":10.3},{"name":"Radiotherapy alone","n":208,"value":30.4}],"hr":0.38,"ci":[0.24,0.6],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(10)70223-0"}],"replication":"RTOG 8531 and SPCG-7 found the same direction; EORTC 22961 then showed that shortening the hormone therapy to 6 months gives up part of the gain."},{"id":"eortc-22881-boost","kind":"trial","name":"EORTC 22881-10882 (boost against no boost)","aka":["EORTC boost trial","EORTC 22881","boost versus no boost trial"],"tldr":"An extra dose of radiotherapy aimed at the place the lump came from cuts the chance of the cancer returning in that breast by about a third, but it does not help anyone live longer and it triples the chance of the breast becoming hard and scarred. That trade is the reason the extra dose is offered by risk rather than to everybody.","summary":"Between 1989 and 1996, EORTC 22881-10882 randomised 5,318 patients with stage I or II breast cancer, all of whom had a microscopically complete excision and 50 Gy of whole-breast irradiation over five weeks, to a further 16 Gy to the tumour bed or to nothing further. Overall survival was the primary endpoint. The twenty-year report is the one to read.\n\nAt a median 17.2 years, twenty-year overall survival was 59.7 percent with the boost and 61.1 percent without it (hazard ratio 1.05, 99 percent confidence interval 0.92 to 1.19, p=0.323): the boost does not change how long people live. What it changes is local control. Ipsilateral breast tumour recurrence was the first failure in 354 patients (13 percent) without the boost and 237 (9 percent) with it (hazard ratio 0.65, 99 percent confidence interval 0.52 to 0.81, p<0.0001), a twenty-year cumulative incidence of 16.4 against 12.0 percent. About three-quarters of those recurrences led to a mastectomy in both arms.\n\nThe cost is measurable and permanent: the twenty-year cumulative incidence of severe fibrosis was 1.8 percent without the boost and 5.2 percent with it (p<0.0001). The trial's own conclusion is that the absolute benefit is largest in young patients and that the extra dose can be avoided in most patients over 60. NICE NG101 recommendation 1.13.17 offers a boost to women at high risk of local recurrence, and 1.13.18 requires that the side effects be explained.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02295033","url":"https://clinicaltrials.gov/study/NCT02295033"},{"label":"EORTC boost trial twenty-year follow-up (Lancet Oncology 2015)","url":"https://doi.org/10.1016/S1470-2045(14)71156-8"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["imrt-igrt","hypofractionated-radiotherapy"],"targets":[],"drugs":[],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["tumour-bed-boost","resection-margins","lumpectomy"],"trials":["eortc-10801","import-low"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02295033","phase":"3","setting":"Stage I and II breast cancer after microscopically complete excision and whole-breast irradiation of 50 Gy in five weeks: an extra 16 Gy to the tumour bed against no extra dose, with overall survival as the primary endpoint and twenty-year follow-up","sponsor":"European Organisation for Research and Treatment of Cancer","result":"Twenty-year ipsilateral breast recurrence 12.0 percent with a 16 Gy boost against 16.4 percent without (hazard ratio 0.65), no difference in overall survival, and severe fibrosis 5.2 against 1.8 percent.","started":"1989-05","yearReported":2015,"enrolled":5318,"enrolledBasis":"randomised","enrolledNote":"2,657 patients were randomised to no boost and 2,661 to a boost, 5,318 in all; the ClinicalTrials.gov record NCT02295033 was created retrospectively and states no enrolment figure.","outcomes":[{"endpoint":"Overall survival at 20 years","primary":true,"unit":"%","arms":[{"name":"16 Gy tumour-bed boost","n":2661,"value":59.7,"note":"99 percent confidence interval 56.3 to 63.0"},{"name":"No boost","n":2657,"value":61.1,"note":"99 percent confidence interval 57.6 to 64.3"}],"hr":1.05,"p":"0.323","source":"https://doi.org/10.1016/S1470-2045(14)71156-8"},{"endpoint":"Cumulative incidence of ipsilateral breast tumour recurrence at 20 years","unit":"%","arms":[{"name":"16 Gy tumour-bed boost","n":2661,"value":12,"note":"99 percent confidence interval 9.8 to 14.4"},{"name":"No boost","n":2657,"value":16.4,"note":"99 percent confidence interval 14.1 to 18.8"}],"hr":0.65,"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(14)71156-8"},{"endpoint":"Cumulative incidence of severe fibrosis at 20 years","unit":"%","arms":[{"name":"16 Gy tumour-bed boost","n":2661,"value":5.2,"note":"99 percent confidence interval 3.9 to 6.4"},{"name":"No boost","n":2657,"value":1.8,"note":"99 percent confidence interval 1.1 to 2.5"}],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(14)71156-8"}]},{"id":"eortc-22911","kind":"trial","name":"EORTC 22911","aka":["EORTC 22911"],"tldr":"Radiotherapy given straight after prostate surgery kept the PSA down for longer, but over ten years that did not translate into fewer men whose disease actually progressed, and side effects were commoner.","summary":"EORTC 22911 randomised 1,005 men with prostate cancer extending beyond the prostate after radical prostatectomy to 60 Gy of conventional postoperative irradiation over 6 weeks or to a wait-and-see policy until biochemical progression, defined as a PSA above 0.2 micrograms per litre confirmed twice at least 2 weeks apart. Median follow-up was 10.6 years, range 2 months to 16.6 years.\n\nPostoperative irradiation significantly improved biochemical progression-free survival: 198 of 502 men (39.4 percent) against 311 of 503 (61.8 percent) had biochemical or clinical progression or died, hazard ratio 0.49 (95 percent confidence interval 0.41 to 0.59, p<0.0001).\n\nThe qualifications are as important as the result. Improvements in clinical progression-free survival were not maintained at 10 years. Late adverse effects of any type and any grade were more frequent after irradiation: 10-year cumulative incidence 70.8 percent (66.6 to 75.0) against 59.7 percent (55.3 to 64.1), p=0.001. Exploratory analyses suggested benefit in men under 70 and in those with positive surgical margins, and possible harm in men aged 70 or older.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00002511","url":"https://clinicaltrials.gov/study/NCT00002511"},{"label":"EORTC 22911 long-term results (Lancet 2012)","url":"https://doi.org/10.1016/S0140-6736(12)61253-7"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk","prostate-bcr"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["prostatectomy","neoadjuvant-adjuvant","biochemical-recurrence"],"trials":["swog-8794","radicals-rt","artistic-meta-analysis"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002511","phase":"3","setting":"cT0 to T3 prostate cancer extending beyond the prostate after radical prostatectomy, in men 75 or younger: 60 Gy postoperative irradiation to the surgical bed over 6 weeks against a wait-and-see policy until biochemical progression, with biochemical progression-free survival as the primary endpoint","sponsor":"European Organisation for Research and Treatment of Cancer","result":"Biochemical progression-free survival hazard ratio 0.49 (95 percent confidence interval 0.41 to 0.59) at a median 10.6 years, but no maintained clinical progression-free survival benefit and a 10-year late adverse effect incidence of 70.8 against 59.7 percent.","started":"1992-12","yearReported":2012,"enrolled":1005,"enrolledBasis":"randomised","enrolledNote":"1,005 men from 37 European institutions were randomised, 502 to postoperative irradiation and 503 to a wait-and-see policy.","outcomes":[{"endpoint":"Biochemical or clinical progression or death","primary":true,"unit":"%","arms":[{"name":"Postoperative irradiation, 60 Gy","n":502,"value":39.4},{"name":"Wait and see","n":503,"value":61.8}],"hr":0.49,"ci":[0.41,0.59],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(12)61253-7"},{"endpoint":"Late adverse effects of any grade at 10 years","unit":"%","arms":[{"name":"Postoperative irradiation, 60 Gy","n":502,"value":70.8},{"name":"Wait and see","n":503,"value":59.7}],"p":"0.001","source":"https://doi.org/10.1016/S0140-6736(12)61253-7"}],"replication":"SWOG 8794 found a metastasis-free and overall survival benefit in pT3N0M0 disease; the ARTISTIC meta-analysis later found no event-free survival advantage for adjuvant over early salvage radiotherapy."},{"id":"eortc-22922","kind":"trial","name":"EORTC 22922/10925","aka":[],"tldr":"EORTC 22922 showed that irradiating the internal mammary and supraclavicular nodes reduces breast cancer recurrence and death, with a small effect on overall survival, and made regional nodal irradiation standard for node-positive disease.","summary":"EORTC 22922/10925 randomised 4,004 women with node-positive or medially located early breast cancer to whole-breast or chest wall radiotherapy with or without irradiation of the internal mammary and medial supraclavicular nodes. Ten-year overall survival was 82.3 percent with nodal irradiation and 80.7 percent without (hazard ratio 0.87, borderline), with fewer distant recurrences and breast cancer deaths (Poortmans and colleagues, New England Journal of Medicine 2015); 15-year results confirmed lower breast cancer mortality without an overall survival difference.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00002851","url":"https://clinicaltrials.gov/study/NCT00002851"},{"label":"NEJM 2015","url":"https://doi.org/10.1056/NEJMoa1415369"}],"tags":["radiation-wave4"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive","tnbc","breast-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["planning-target-volume","post-mastectomy-radiotherapy"],"trials":["ma-20","supremo","nsabp-b51"],"people":[],"bottlenecks":[],"keyPapers":["paper-eortc-22922-n-engl-j-med-2015","paper-eortc-22922-lancet-oncol-2020-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002851","phase":"3","setting":"Early breast cancer with involved axillary nodes or a central or medial tumour: regional nodal irradiation (internal mammary and medial supraclavicular) added to breast or chest wall radiotherapy, versus none","sponsor":"EORTC","result":"10-year overall survival 82.3% vs 80.7% (hazard ratio 0.87); fewer distant recurrences and breast cancer deaths.","started":"1996-07","yearReported":2015,"enrolled":4004,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 10 years","primary":true,"unit":"%","arms":[{"name":"Regional nodal irradiation","n":2002,"value":82.3},{"name":"No nodal irradiation","n":2002,"value":80.7}]}]},{"id":"eortc-22961","kind":"trial","name":"EORTC 22961","aka":["EORTC 22961","duration of androgen suppression trial"],"tldr":"Tried to show that six months of hormone therapy with radiotherapy is enough for locally advanced prostate cancer. It is not: three years works better.","summary":"EORTC 22961 registered 1,113 men with locally advanced prostate cancer who had already received external beam radiotherapy and 6 months of androgen suppression, and randomised 970 of them to stop (483) or to continue a luteinising hormone-releasing hormone agonist for a further 2.5 years (487). Short-term suppression would have been declared non-inferior if the hazard ratio for overall survival stayed below 1.35.\n\nAt a median 6.4 years, 132 men in the short arm and 98 in the long arm had died, 47 and 29 of them from prostate cancer. Five-year overall mortality was 19.0 percent with short suppression and 15.2 percent with long, and the observed hazard ratio was 1.42 (upper 95.71 percent confidence limit 1.79). Non-inferiority failed (p=0.65). An interim analysis had already shown futility.\n\nThe trial is the reason three years, not six months, is the standard duration of androgen deprivation alongside radiotherapy for locally advanced disease, and the reason a man in that position is asked to accept three years of hot flushes, fatigue, loss of libido and bone loss. Adverse events in both arms included fatigue, diminished sexual function and hot flushes.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00003026","url":"https://clinicaltrials.gov/study/NCT00003026"},{"label":"EORTC 22961 (New England Journal of Medicine 2009)","url":"https://doi.org/10.1056/NEJMoa0810095"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation","imrt-igrt"],"targets":[],"drugs":[],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["adt","hormone-therapy","curative-intent","qol-pro"],"trials":["rtog-9202","dart-01-05-gicor","eortc-22863"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003026","phase":"3","setting":"Locally advanced prostate cancer after external beam radiotherapy and 6 months of androgen suppression: stop there, or continue a luteinising hormone-releasing hormone agonist for a further 2.5 years, with a non-inferiority design for overall survival","sponsor":"European Organisation for Research and Treatment of Cancer","result":"Five-year overall mortality 19.0 percent with 6 months of androgen suppression against 15.2 percent with 3 years; hazard ratio 1.42, non-inferiority not shown (p=0.65).","started":"1997-04","yearReported":2009,"enrolled":970,"enrolledBasis":"randomised","enrolledNote":"1,113 men were registered and 970 were randomised after 6 months of androgen suppression; the randomised figure is the one analysed.","outcomes":[{"endpoint":"Overall mortality at 5 years","primary":true,"unit":"%","arms":[{"name":"Short suppression, 6 months","n":483,"value":19,"note":"Upper 95.71 percent confidence limit 1.79."},{"name":"Long suppression, 3 years","n":487,"value":15.2}],"hr":1.42,"p":"0.65 for non-inferiority","source":"https://doi.org/10.1056/NEJMoa0810095"}],"replication":"RTOG 9202 (1,554 men) found the same direction for 28 months against 4 months, and DART 01/05 GICOR (355 men) for 28 months against 4 months with high-dose radiotherapy."},{"id":"eortc-22991","kind":"trial","name":"EORTC 22991","aka":["EORTC 22991"],"tldr":"Six months of hormone therapy added to modern dose-escalated radiotherapy roughly halves the chance the PSA comes back, at every radiation dose tested.","summary":"EORTC 22991 randomised 819 men, median age 70, of whom 74.8 percent were intermediate risk and 24.8 percent high risk, to radiotherapy alone or radiotherapy with 6 months of androgen suppression given as two 3-monthly depot injections of a luteinising hormone-releasing hormone agonist starting on the first day of radiotherapy. Each centre chose its radiation dose: 70, 74 or 78 Gy.\n\nAt a median 7.2 years and with 319 events, androgen suppression significantly improved biochemical disease-free survival, hazard ratio 0.52 (95 percent confidence interval 0.41 to 0.66, p<0.001), and clinical progression-free survival, hazard ratio 0.63 (0.48 to 0.84, p=0.001) with 205 events. Overall survival data were not mature at that analysis.\n\nThe exploratory analysis that matters clinically found no statistically significant interaction between the effect of androgen suppression and the radiation dose (heterogeneity p=0.79 for biochemical disease-free survival and p=0.66 for progression-free survival). Dose escalation does not remove the need for hormone therapy, which is the question the trial was designed to answer.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00021450","url":"https://clinicaltrials.gov/study/NCT00021450"},{"label":"EORTC 22991 (Journal of Clinical Oncology 2016)","url":"https://doi.org/10.1200/JCO.2015.64.8055"}],"tags":[],"related":[],"cancers":["prostate","prostate-intermediate-risk","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation","imrt-igrt"],"targets":[],"drugs":[],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["adt","curative-intent","biochemical-recurrence"],"trials":["rtog-9408","dart-01-05-gicor","eortc-22863"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00021450","phase":"3","setting":"Intermediate-risk or high-risk localised prostate cancer, cT1b-c with PSA 10 or more or Gleason 7 or more, or cT2a: radiotherapy at a centre-chosen dose of 70, 74 or 78 Gy, with or without 6 months of androgen suppression started on day 1, with biochemical disease-free survival as the primary endpoint","sponsor":"European Organisation for Research and Treatment of Cancer","result":"Six months of androgen suppression added to radiotherapy improved biochemical disease-free survival (hazard ratio 0.52, 95 percent confidence interval 0.41 to 0.66) and clinical progression-free survival (0.63, 0.48 to 0.84), with no interaction with radiation dose.","started":"2001-04","yearReported":2016,"enrolled":819,"enrolledBasis":"randomised","enrolledNote":"819 men were centrally randomised 1:1; in the radiotherapy arm 407 of 409 received radiotherapy.","outcomes":[{"endpoint":"Biochemical disease-free survival","primary":true,"arms":[{"name":"Radiotherapy with 6 months of androgen suppression","n":410},{"name":"Radiotherapy alone","n":409}],"hr":0.52,"ci":[0.41,0.66],"p":"<0.001","source":"https://doi.org/10.1200/JCO.2015.64.8055"},{"endpoint":"Clinical progression-free survival","arms":[{"name":"Radiotherapy with 6 months of androgen suppression","n":410},{"name":"Radiotherapy alone","n":409}],"hr":0.63,"ci":[0.48,0.84],"p":"0.001","source":"https://doi.org/10.1200/JCO.2015.64.8055"}],"replication":"RTOG 94-08 showed an overall survival benefit for 4 months of androgen suppression in the same risk band, and DART 01/05 GICOR showed that longer suppression adds more in high-risk disease."},{"id":"eortc-26951","kind":"trial","name":"EORTC 26951","aka":[],"tldr":"EORTC 26951, the European twin of RTOG 9402, confirmed that PCV chemotherapy after radiotherapy greatly lengthens survival in 1p/19q co-deleted oligodendrogliomas.","summary":"EORTC 26951 randomised 368 patients with anaplastic oligodendroglioma or oligoastrocytoma to 59.4 Gy radiotherapy with or without six cycles of adjuvant PCV. With a median follow-up of nearly 12 years, overall survival improved with PCV (42.3 versus 30.6 months overall); in 1p/19q co-deleted tumours median survival was not reached with PCV versus 112 months with radiotherapy alone (van den Bent and colleagues, Journal of Clinical Oncology 2013).","status":"positive","asOf":"2026-09-17","links":[{"label":"JCO 2013","url":"https://doi.org/10.1200/JCO.2012.43.2229"}],"tags":["radiation-wave4"],"related":[],"cancers":["glioblastoma","brain-tumours","oligodendroglioma"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["lomustine","vincristine","procarbazine"],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["chemoradiation"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Anaplastic oligodendroglial tumours: radiotherapy followed by six cycles of PCV chemotherapy versus radiotherapy alone","sponsor":"EORTC","result":"Median overall survival 42.3 vs 30.6 months overall; in 1p/19q co-deleted tumours not reached vs 112 months.","yearReported":2013,"enrolled":368,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Radiotherapy + adjuvant PCV","value":42.3},{"name":"Radiotherapy alone","value":30.6}],"hr":0.75,"ci":[0.6,0.95],"source":"https://doi.org/10.1200/JCO.2012.43.2229"},{"endpoint":"Overall survival, 1p/19q co-deleted (80 patients)","unit":"months","arms":[{"name":"Radiotherapy + adjuvant PCV","note":"Not reached"},{"name":"Radiotherapy alone","value":112}],"hr":0.56,"ci":[0.31,1.03],"source":"https://doi.org/10.1200/JCO.2012.43.2229"}]},{"id":"eortc-26981","kind":"trial","name":"EORTC 26981 / NCIC CE.3 (Stupp trial)","aka":[],"tldr":"The 2005 trial that set the treatment every glioblastoma patient still receives. Nothing has replaced it in twenty years.","summary":"EORTC 26981 with NCIC CE.3, the Stupp trial, NCT00006353, reported in 2005, set the treatment every glioblastoma patient still receives: radiotherapy with concurrent and adjuvant temozolomide, which nothing has replaced in twenty years. It randomised 573 patients with newly diagnosed glioblastoma to radiotherapy with or without temozolomide, met its primary overall survival endpoint, and its five-year update in 2009 showed a small but real minority of long-term survivors, while the companion analysis by Hegi showed that MGMT promoter methylation predicts benefit. OnCo links it to temozolomide, the MGMT promoter methylation term, Martin J. van den Bent, Monika E. Hegi, Michael Weller and Roger Stupp, and to the brain as a bottleneck. The Stupp regimen has been the control arm of every glioblastoma trial since, and whether anything can beat it remains the field's central question.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT00006353","url":"https://clinicaltrials.gov/study/NCT00006353"}],"tags":[],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["temozolomide"],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["mgmt"],"trials":[],"people":["martin-van-den-bent","monika-hegi","michael-weller","roger-stupp"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00006353","phase":"3","setting":"Newly diagnosed glioblastoma: radiotherapy + concurrent and adjuvant temozolomide vs radiotherapy alone","sponsor":"EORTC / NCIC","result":"OS 14.6 vs 12.1 months, HR 0.63.","started":"2000-07","yearReported":2005,"enrolled":575,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Radiotherapy + temozolomide","n":287,"value":14.6},{"name":"Radiotherapy alone","n":286,"value":12.1}],"hr":0.63,"ci":[0.52,0.75],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa043330"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Radiotherapy + temozolomide","value":9.8},{"name":"Radiotherapy alone","value":1.9}],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(09)70025-7/fulltext"}],"replication":"The Stupp regimen has been the control arm of every glioblastoma trial since; the MGMT-methylated benefit was confirmed repeatedly."},{"id":"eortc-40983","kind":"trial","name":"EORTC 40983","aka":["EPOC"],"tldr":"Chemotherapy around liver surgery delayed recurrence but, after eight years, did not extend life. It is still given, on the strength of the earlier endpoint.","summary":"EORTC 40983 randomised 364 patients with up to four resectable colorectal liver metastases to perioperative FOLFOX4 (six cycles before and six after surgery) or surgery alone. The earlier report showed better progression-free survival. At a median 8.5 years, 107 of 182 patients in the chemotherapy group had died against 114 of 182 with surgery alone (hazard ratio 0.88, 95% CI 0.68 to 1.14, p=0.34); median overall survival was 61.3 against 54.3 months and five-year survival 51.2 against 47.8 percent. The authors kept perioperative FOLFOX4 as the reference treatment because of the progression-free survival gain, but the trial is the honest measure of how much chemotherapy adds to a well-done liver resection: not demonstrably any life.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00006479","url":"https://clinicaltrials.gov/study/NCT00006479"},{"label":"EORTC 40983: perioperative FOLFOX4 and surgery versus surgery alone for resectable liver metastases, long-term results (Lancet Oncology 2013)","url":"https://doi.org/10.1016/S1470-2045(13)70447-9"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","oxaliplatin","fluorouracil","leucovorin"],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["hepatectomy","oligometastatic","neoadjuvant-adjuvant"],"trials":["new-epoc","cairo5"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00006479","phase":"3","setting":"Up to four resectable colorectal liver metastases: six cycles of FOLFOX4 before and six after liver resection, against surgery alone","sponsor":"European Organisation for Research and Treatment of Cancer","result":"No overall survival difference at 8.5 years (hazard ratio 0.88); the earlier progression-free survival benefit stands.","started":"2000-09","yearReported":2013,"enrolled":364,"enrolledBasis":"randomised","enrolledNote":"364 patients were randomised (182 per group); the registry entry carries no enrolment figure.","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Perioperative FOLFOX4 and surgery","n":182,"value":61.3},{"name":"Surgery alone","n":182,"value":54.3}],"hr":0.88,"ci":[0.68,1.14],"p":"0.34","source":"https://doi.org/10.1016/S1470-2045(13)70447-9"}]},{"id":"eortc-62012","kind":"trial","name":"EORTC 62012","aka":[],"tldr":"Adding ifosfamide to doxorubicin shrank more sarcomas and delayed progression but did not significantly lengthen life, so doxorubicin alone stayed the standard unless a tumour needs to shrink.","summary":"EORTC 62012 randomised 455 patients with previously untreated advanced soft tissue sarcoma to doxorubicin 75 mg/m2 alone or the same dose with ifosfamide 10 g/m2 and growth factor support. The combination improved objective response and progression-free survival at the cost of much greater haematological toxicity, but the primary endpoint of overall survival was not significantly improved. Published in Lancet Oncology in 2014, it is the reference for the first-line choice in advanced sarcoma: single-agent doxorubicin for palliation, the combination when response is needed, for example to make a tumour operable or relieve symptoms.","status":"completed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00061984","url":"https://clinicaltrials.gov/study/NCT00061984"},{"label":"Lancet Oncology 2014","url":"https://doi.org/10.1016/S1470-2045(14)70063-4"}],"tags":["subtype-page"],"related":[],"cancers":["extremity-soft-tissue-sarcoma","undifferentiated-pleomorphic-sarcoma","malignant-peripheral-nerve-sheath-tumour","sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["doxorubicin","ifosfamide"],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00061984","phase":"3","setting":"Advanced soft tissue sarcoma, first line: doxorubicin plus ifosfamide versus doxorubicin alone","sponsor":"EORTC","result":"Median OS 14.3 vs 12.8 months (HR 0.83, not significant); median PFS 7.4 vs 4.6 months (HR 0.74).","started":"2003-04","yearReported":2014,"enrolled":455,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Doxorubicin + ifosfamide","value":14.3},{"name":"Doxorubicin","value":12.8}],"hr":0.83,"ci":[0.67,1.03],"p":"0.076","source":"https://doi.org/10.1016/S1470-2045(14)70063-4"},{"endpoint":"Progression-free survival (median)","unit":"months","arms":[{"name":"Doxorubicin + ifosfamide","value":7.4},{"name":"Doxorubicin","value":4.6}],"hr":0.74,"ci":[0.6,0.9],"source":"https://doi.org/10.1016/S1470-2045(14)70063-4"}]},{"id":"eortc-h10","kind":"trial","name":"EORTC/LYSA/FIL H10","aka":["H10","EORTC H10","Early positron emission tomography response-adapted treatment in early Hodgkin lymphoma"],"tldr":"In early Hodgkin lymphoma, people whose scan was still positive after two rounds did much better on more intensive chemotherapy, and people whose scan was clear still needed their radiotherapy.","summary":"H10 tested both directions of scan-adapted treatment at once, in people with stage I and II Hodgkin lymphoma classified by the European Organisation for Research and Treatment of Cancer criteria as favourable or unfavourable. The standard arm was ABVD followed by involved-node radiotherapy irrespective of the scan. In the experimental arm, a negative scan after two cycles meant ABVD alone, tested for non-inferiority; a positive scan meant switching to two cycles of escalated BEACOPP with involved-node radiotherapy, tested for superiority.\n\nOf 1,950 randomly assigned patients, 1,925 had an early scan and 361 (18.8 per cent) were positive. In those scan-positive patients, intensification worked: five-year progression-free survival rose from 77.4 per cent with ABVD and radiotherapy to 90.6 per cent with escalated BEACOPP and radiotherapy (hazard ratio 0.42, 95 per cent confidence interval 0.23 to 0.74, p = 0.002). In the scan-negative patients, non-inferiority of ABVD alone could not be demonstrated in either group: in the favourable group five-year progression-free survival was 99.0 per cent with combined treatment against 87.1 per cent without (hazard ratio 15.8, 3.8 to 66.1), and in the unfavourable group 92.1 against 89.6 per cent (hazard ratio 1.45, 0.8 to 2.5).\n\nThe 99.0 per cent figure in the favourable group is the most striking number in early Hodgkin lymphoma and sets the bar any radiotherapy-sparing strategy has to clear. Together with HD16 and RAPID it establishes that an interim scan identifies who needs more treatment far better than it identifies who needs less.","status":"mixed","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT00433433","url":"https://clinicaltrials.gov/study/NCT00433433"},{"label":"Journal of Clinical Oncology 2017","url":"https://doi.org/10.1200/JCO.2016.68.6394"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["early-stage-classical-hodgkin-lymphoma","hodgkin-lymphoma"],"sections":["radiation","chemotherapy","imaging"],"technologies":["pet-ct","radiotherapy","imrt-igrt"],"targets":[],"drugs":["doxorubicin","bleomycin","vinblastine","dacarbazine","etoposide","cyclophosphamide","vincristine","procarbazine","prednisone"],"companies":[],"institutions":[],"pathways":[],"terms":["deauville-score","abvd-beacopp","non-inferiority"],"trials":["hd16","hd10","rathl"],"people":[],"bottlenecks":["b-survivorship","b-toxicity-qol"],"keyPapers":["paper-eortc-h10-pet-adapted-early-hodgkin-jco-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00433433","phase":"3","setting":"Stage I and II Hodgkin lymphoma: standard ABVD with involved-node radiotherapy against treatment adapted to the scan after two cycles, intensifying for a positive scan and dropping radiotherapy for a negative one","sponsor":"European Organisation for Research and Treatment of Cancer","result":"Switching a positive interim scan to escalated BEACOPP raised five-year progression-free survival from 77.4 to 90.6 per cent; omitting radiotherapy after a negative scan was not non-inferior in either risk group.","started":"2006-10","startedType":"actual","yearReported":2017,"enrolled":1925,"enrolledBasis":"analysed","enrolledNote":"1,950 patients were randomly assigned and 1,925 had an early scan, of whom 361 (18.8 per cent) were positive.","outcomes":[{"endpoint":"Progression-free survival at 5 years, scan-positive patients","primary":true,"unit":"%","arms":[{"name":"Escalated BEACOPP with involved-node radiotherapy","value":90.6},{"name":"ABVD with involved-node radiotherapy","value":77.4}],"hr":0.42,"ci":[0.23,0.74],"p":"0.002","source":"https://doi.org/10.1200/JCO.2016.68.6394"},{"endpoint":"Progression-free survival at 5 years, scan-negative favourable group","unit":"%","arms":[{"name":"ABVD with involved-node radiotherapy","value":99},{"name":"ABVD alone","value":87.1}],"hr":15.8,"ci":[3.8,66.1]},{"endpoint":"Progression-free survival at 5 years, scan-negative unfavourable group","unit":"%","arms":[{"name":"ABVD with involved-node radiotherapy","value":92.1},{"name":"ABVD alone","value":89.6}],"hr":1.45,"ci":[0.8,2.5]}],"replication":"The scan-negative finding matches HD16 and the United Kingdom RAPID trial; the scan-positive intensification finding matches RATHL in advanced disease."},{"id":"nct03428477","kind":"trial","name":"EPA for Metastasis Trial 2","aka":["EMT2"],"tldr":"A phase 3 trial in colorectal cancer, run by Mark A Hull, PhD FRCP, active but no longer recruiting.","summary":"EPA for Metastasis Trial 2 is a phase 3, randomised interventional study registered as NCT03428477 by Mark A Hull, PhD FRCP, with a registry enrolment figure of 418 participants, started 2018-05-02 and due to reach its primary completion in 2025-11-30. Interventions recorded: Icosapent Ethyl; Placebo. Conditions listed: Liver Metastasis; Colon Cancer. Primary outcome: Progression Free Survival (PFS). Colorectal eligibility wording from the registry: \"* Histological diagnosis of colorectal cancer with evidence of liver metastases\". Sites: United Kingdom. United Kingdom sites listed: 13. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03428477","url":"https://clinicaltrials.gov/study/NCT03428477"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Oxford University Hospital NHS Foundation Trust (Oxford); Hampshire Hospitals NHS Foundation Trust (Basingstoke); Aintree University Hospitals NHS Foundation Trust (Aintree); University Hospitals Birmingham NHS Foundation Trust (Birmingham); Cambridge UniversityHospitals NHS Foundation Trust (Cambridge); University Hospital of Wales (Cardiff); Leeds Teaching Hospitals NHS Foundation Trust (Leeds); King's College London (London); Royal Free London NHS Foundation Trust (London); Newcastle Upon Tyne Hospitals NHS Foundation Trust (Newcastle); Nottingham University Hospitals NHS Trust (Nottingham); Sheffield Teaching Hospitals NHS Foundation Trust (Sheffield) and 1 more."],"nct":"NCT03428477","phase":"3","setting":"A Randomised Placebo-controlled Phase III Trial of the Effect of the Omega-3 Fatty Acid Eicosapentaenoic Acid (EPA) on Colorectal Cancer Recurrence and Survival After Surgery for Resectable Liver Metastases","sponsor":"Mark A Hull, PhD FRCP","started":"2018-05-02","startedType":"actual","enrolled":418,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03516708","kind":"trial","name":"Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 1/2 trial of epacadostat in colorectal cancer, run by Washington University School of Medicine, now recruiting.","summary":"Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer is a phase 1/2, interventional study registered as NCT03516708 by Washington University School of Medicine, with a registry enrolment figure of 49 participants, started 2020-01-06 and due to reach its primary completion in 2027-07-15. Interventions recorded: Epacadostat; Short-course radiation therapy; CAPOX chemotherapy; FOLFOX chemotherapy. Conditions listed: Rectal Cancer. Primary outcome: Phase I only: Recommended phase II dose (RP2D) of epacadostat with standard of care radiation and chemotherapy in preoperative treatment of locally advanced rectal cancer; Phase II Treatment Cohort only: Neoadjuvant Rectal (NAR) Score. Colorectal eligibility wording from the registry: \"* Newly diagnosed pathologically-confirmed locally advanced rectal cancer (defined by 8th edition AJCC stage 2 or 3, or stage 1 not eligible for sphincter-sparing surgery) with plans to proceed with total neoadjuvant short course radiation as part of their neoadjuvant therapy as confirmed by treatin\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03516708","url":"https://clinicaltrials.gov/study/NCT03516708"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["epacadostat"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03516708","phase":"1/2","setting":"Phase I/II Study of Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer","sponsor":"Washington University School of Medicine","started":"2020-01-06","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"epcore-dlbcl-1","kind":"trial","name":"EPCORE DLBCL-1","aka":[],"tldr":"Epcoritamab delayed progression but did not clearly extend life versus chemotherapy in relapsed lymphoma, missing its US primary endpoint in January 2026.","summary":"EPCORE DLBCL-1, trial NCT04628494 sponsored by Genmab and AbbVie and reported on 16 January 2026, was the confirmatory phase 3 for epcoritamab in relapsed or refractory diffuse large B-cell lymphoma after at least one line in transplant-ineligible patients, and it delayed progression but did not clearly extend life against investigator's choice of rituximab-gemcitabine-oxaliplatin or bendamustine-rituximab. It randomised 552 patients and improved progression-free survival, but overall survival, the sole primary endpoint in the United States, was not significantly different, so the study did not meet its US endpoint while the dual endpoints used elsewhere were partially met. The regulatory implications for the accelerated approval were under discussion, and whether a bispecific alone can beat chemotherapy on survival is the open question.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04628494","url":"https://clinicaltrials.gov/study/NCT04628494"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["epcoritamab"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["catherine-thieblemont"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04628494","phase":"3","setting":"R/R DLBCL after ≥1 line, transplant-ineligible: epcoritamab monotherapy vs investigator's choice (R-GemOx or BR)","sponsor":"Genmab / AbbVie","result":"PFS HR 0.74; OS HR 0.96 (NS).","started":"2021-01-13","startedType":"actual","yearReported":2026,"enrolled":552,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"arms":[{"name":"Epcoritamab"},{"name":"Investigator's choice"}],"hr":0.96,"ci":[0.77,1.2],"source":"https://ir.genmab.com/news-releases/news-release-details/genmab-announces-topline-results-epcoritamab-duobodyr-cd3xcd20/"},{"endpoint":"Progression-free survival","arms":[{"name":"Epcoritamab"},{"name":"Investigator's choice"}],"hr":0.74,"ci":[0.6,0.92]}]},{"id":"epcore-dlbcl-2","kind":"trial","name":"EPCORE DLBCL-2","aka":[],"tldr":"Tests whether adding a bispecific to first-line chemotherapy cures more patients up front.","summary":"EPCORE DLBCL-2, trial NCT05578976 sponsored by Genmab and AbbVie, tests whether adding a fixed duration of the bispecific epcoritamab to first-line R-CHOP cures more patients with untreated diffuse large B-cell lymphoma up front. Topline results were announced in 2026 and presented at EHA 2026, and together with frontMIND and POLARIX the trial defines the frontline options for higher-risk disease. OnCo links it to lymphoma and epcoritamab. Whether a T-cell engager added to chemotherapy improves cure rates enough to justify its toxicity and cost in the first line is the question its data will answer.","status":"active","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05578976","url":"https://clinicaltrials.gov/study/NCT05578976"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["epcoritamab"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05578976","phase":"3","setting":"Untreated DLBCL: epcoritamab + R-CHOP vs R-CHOP","sponsor":"Genmab / AbbVie","started":"2023-02-08","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"epcore-nhl-1","kind":"trial","name":"EPCORE NHL-1","aka":[],"tldr":"EPCORE NHL-1 was the pivotal single-arm study behind epcoritamab's approval; about half of complete responders are still in remission at three years.","summary":"EPCORE NHL-1, trial NCT03625037 sponsored by Genmab and AbbVie and reported in 2022, was the pivotal single-arm study behind epcoritamab's approval in relapsed or refractory large B-cell lymphoma after at least two lines, and about half of complete responders remain in remission at three years. In the 157-patient expansion cohort the objective response rate was 63 percent with complete responses in 39 percent, cytokine release syndrome occurred in about half but was rarely severe, and the three-year follow-up found many complete responders with undetectable circulating tumour DNA. Without a randomised comparison, and with the confirmatory EPCORE DLBCL-1 missing its US survival endpoint, whether the drug improves survival over chemotherapy is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03625037","url":"https://clinicaltrials.gov/study/NCT03625037"}],"tags":[],"related":["lymphoma-roadmap","polargo","starglo"],"cancers":["dlbcl"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["epcoritamab"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":["orr","crs"],"trials":[],"people":["catherine-thieblemont"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03625037","phase":"1/2","setting":"R/R LBCL after ≥2 lines (single-arm expansion): epcoritamab monotherapy","sponsor":"Genmab / AbbVie","result":"ORR 63%, CR 39%.","started":"2018-06-26","startedType":"actual","yearReported":2022,"enrolled":157,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Epcoritamab","n":157,"value":63.1}],"source":"https://ascopubs.org/doi/10.1200/JCO.22.01725"},{"endpoint":"Complete response rate","unit":"%","arms":[{"name":"Epcoritamab","n":157,"value":38.9}],"source":"https://doi.org/10.1200/JCO.22.01725"}]},{"id":"era-223","kind":"trial","name":"ERA 223","aka":["ERA 223","ERA223"],"tldr":"Combining a bone-seeking radioactive drug with abiraterone did not help, and it nearly tripled the rate of broken bones. The trial was unblinded early and the combination is now contraindicated.","summary":"ERA 223 is the clearest example in prostate cancer of a combination that was harmful, and of a harm that was preventable. It randomised 806 men with chemotherapy-naive, bone-metastatic castration-resistant prostate cancer to abiraterone with prednisone or prednisolone plus either radium-223 or placebo.\n\nThe study was unblinded prematurely on 17 November 2017 after an unplanned ad hoc analysis found more fractures and more deaths in the radium-223 group, although by then every man had finished radium-223 or placebo.\n\nAt the primary analysis (data cutoff 15 February 2018, median follow-up 21.2 months) the primary endpoint had not been met: 196 of 401 men (49 percent) on radium-223 and 190 of 405 (47 percent) on placebo had a symptomatic skeletal event or died, median symptomatic skeletal event-free survival 22.3 months (95 percent confidence interval 20.4 to 24.8) against 26.0 months (21.8 to 28.3), hazard ratio 1.122 (0.917 to 1.374, p=0.2636).\n\nThe fracture figures are the reason the trial is remembered. Fractures of any grade occurred in 112 of 392 men (29 percent) on radium-223 and 45 of 394 (11 percent) on placebo; grade 3 to 4 fractures in 36 (9 percent) against 12 (3 percent). Bone-protecting agents were not mandatory.\n\nPEACE-3 later tested the same concept with enzalutamide and with bone-protecting agents mandatory for everyone, and found an overall survival benefit with a hazard ratio of 0.76. The difference between the two trials is the single most useful practical fact about radium-223 combinations: give the bone-protecting agent.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02043678","url":"https://clinicaltrials.gov/study/NCT02043678"},{"label":"ERA 223 (Lancet Oncology 2019)","url":"https://doi.org/10.1016/S1470-2045(18)30860-X"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["targeted-alpha-therapy","androgen-deprivation"],"targets":[],"drugs":["radium-223","abiraterone","prednisone"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":["bone-metastases","castration-resistance"],"trials":["peace-3","alsympca"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02043678","phase":"3","setting":"Chemotherapy-naive, asymptomatic or mildly symptomatic castration-resistant prostate cancer with bone metastases: abiraterone acetate 1000 mg daily with prednisone or prednisolone 5 mg twice daily for everyone, plus up to six intravenous injections of radium-223 at 55 kBq/kg or placebo every 4 weeks, with symptomatic skeletal event-free survival as the primary endpoint","sponsor":"Bayer","result":"Median symptomatic skeletal event-free survival 22.3 against 26.0 months (hazard ratio 1.122, 95 percent confidence interval 0.917 to 1.374, p=0.2636): no benefit. Fractures of any grade in 29 against 11 percent, grade 3 to 4 fractures in 9 against 3 percent.","started":"2014-03-30","startedType":"actual","yearReported":2019,"enrolled":806,"enrolledBasis":"randomised","enrolledNote":"806 men were randomly assigned at 165 oncology and urology centres in 19 countries; the study was unblinded prematurely on 17 November 2017.","outcomes":[{"endpoint":"Symptomatic skeletal event-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Radium-223 with abiraterone and prednisone","n":401,"value":22.3},{"name":"Placebo with abiraterone and prednisone","n":405,"value":26}],"hr":1.122,"ci":[0.917,1.374],"p":"0.2636","source":"https://doi.org/10.1016/S1470-2045(18)30860-X"},{"endpoint":"Fracture, any grade","unit":"%","arms":[{"name":"Radium-223 with abiraterone and prednisone","n":392,"value":29},{"name":"Placebo with abiraterone and prednisone","n":394,"value":11}],"source":"https://doi.org/10.1016/S1470-2045(18)30860-X"}],"replication":"PEACE-3 tested the same combination concept with enzalutamide and mandatory bone-protecting agents and found an overall survival hazard ratio of 0.76 (0.60 to 0.96), so the harm is attributable to the missing bone protection rather than to the radioligand alone."},{"id":"nct06810375","kind":"trial","name":"Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery","aka":[],"tldr":"A phase 3 trial in lung cancer, run by George Washington University, now recruiting.","summary":"Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery is a phase 3, randomised interventional study registered as NCT06810375 by George Washington University, with a registry enrolment figure of 120 participants, started 2025-03-01 and due to reach its primary completion in 2028-02-28. Interventions recorded: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®); Intercostal nerve block. Conditions listed: Lung Cancers. Primary outcome: Postoperative pain control assessment; Morphine equivalent assessment. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06810375","url":"https://clinicaltrials.gov/study/NCT06810375"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06810375","phase":"3","setting":"Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery","sponsor":"George Washington University","started":"2025-03-01","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"ergo2","kind":"trial","name":"ERGO2: ketogenic diet and fasting during re-irradiation of recurrent glioma","aka":[],"tldr":"The only randomised trial of a ketogenic diet in brain tumours found no benefit. Patients could follow the diet and their ketone levels rose, but progression came just as quickly.","summary":"50 patients were randomised 1:1. The intervention was feasible and safe: glucose fell and ketones rose as intended, and the diet was well tolerated over nine days. Progression-free survival at 6 months, the primary endpoint, did not differ (20% vs 16%; median PFS 3.2 vs 3.4 months), nor did overall survival (median 11.1 vs 10.5 months). The trial is small and the dietary exposure brief, so it cannot exclude a benefit from sustained ketosis; equally, longer feasibility studies (KETOCAN, modified Atkins with standard chemoradiation) show adherence declining by three months. Together they define the current state: ketogenic diets in glioma are feasible, unproven, and widely promoted to patients as if they were not.","status":"negative","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT01754350","url":"https://clinicaltrials.gov/study/NCT01754350"},{"label":"Voss et al. (Int J Radiat Oncol Biol Phys 2020)","url":"https://doi.org/10.1016/j.ijrobp.2020.06.021"}],"tags":[],"related":["idea-nl-ketogenic-gbm-definitive-trial"],"cancers":["glioblastoma"],"sections":["nutrition-lifestyle"],"technologies":["ketogenic-diet-glioblastoma","metabolic-therapy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["warburg-effect-diet-claims","warburg-effect","pfs"],"trials":[],"people":[],"bottlenecks":["b-misinformation","b-negative-results"],"keyPapers":["paper-voss-int-j-radiat-oncol-biol-phys"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01754350","phase":"2","setting":"Recurrent glioblastoma and other malignant gliomas undergoing re-irradiation: 6-day calorie-restricted ketogenic diet plus 3-day fasting during radiotherapy vs standard diet","sponsor":"Goethe University Frankfurt","result":"6-month PFS 20% vs 16%; median OS 11.1 vs 10.5 months; no benefit.","started":"2013-05","yearReported":2020,"enrolled":50,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 6 months","primary":true,"unit":"%","arms":[{"name":"Ketogenic diet + fasting","n":25,"value":20},{"name":"Standard diet","n":25,"value":16}],"source":"https://doi.org/10.1016/j.ijrobp.2020.06.021"}],"replication":"No adequately powered trial exists. Feasibility studies concordant on tolerability, silent on efficacy."},{"id":"erivance","kind":"trial","name":"ERIVANCE BCC","aka":[],"tldr":"ERIVANCE showed that a pill blocking the hedgehog pathway shrinks most advanced basal cell carcinomas that surgery and radiotherapy can no longer control, and it produced the first approved drug for this cancer.","summary":"ERIVANCE BCC was a single-arm phase 2 trial of vismodegib, the first inhibitor of the hedgehog pathway receptor smoothened, in basal cell carcinoma that was metastatic or locally advanced and inappropriate for surgery or radiotherapy. Nearly all basal cell carcinomas depend on hedgehog signalling through loss of PTCH1 or activation of SMO, which made the pathway an obvious target.\n\nBy independent review the objective response rate was 43 percent in 63 patients with locally advanced disease and 30 percent in 33 with metastatic disease (NEJM 2012); with longer follow-up investigator-assessed responses were higher and lasted about two years in locally advanced disease. Muscle spasms, hair loss, taste loss and weight loss were nearly universal and led many patients to stop.\n\nVismodegib was approved in January 2012, the first hedgehog inhibitor and the first systemic drug for basal cell carcinoma; sonidegib followed on the BOLT trial and cemiplimab was later approved for disease that has failed hedgehog inhibitors.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00833417","url":"https://clinicaltrials.gov/study/NCT00833417"},{"label":"NEJM 2012","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1113713"}],"tags":[],"related":[],"cancers":["locally-advanced-bcc","basal-cell-carcinoma","skin-cancer"],"sections":[],"technologies":["hedgehog-inhibitors"],"targets":["smoothened"],"drugs":["vismodegib"],"companies":["roche-genentech"],"institutions":[],"pathways":["hedgehog","basal-cell-carcinoma-signalling"],"terms":["hedgehog-inhibitor-tolerability"],"trials":["stevie","vismoneo","cemiplimab-advanced-bcc","bolt"],"people":[],"bottlenecks":[],"keyPapers":["paper-erivance-vismodegib-sekulic-nejm-2012","paper-erivance-bmc-cancer-2017-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00833417","phase":"2","setting":"Locally advanced or metastatic basal cell carcinoma: vismodegib 150 mg daily","sponsor":"Genentech","result":"Objective response 43% in locally advanced and 30% in metastatic basal cell carcinoma (independent review).","started":"2009-02-10","startedType":"actual","yearReported":2012,"enrolled":104,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (locally advanced)","primary":true,"unit":"%","arms":[{"name":"Vismodegib","n":63,"value":43}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1113713"},{"endpoint":"Objective response rate (metastatic)","primary":true,"unit":"%","arms":[{"name":"Vismodegib","n":33,"value":30}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1113713"}],"replication":"BOLT (sonidegib) and the STEVIE safety study found the same response rates and the same toxicity profile."},{"id":"erspc","kind":"trial","name":"ERSPC (European Randomized Study of Screening for Prostate Cancer)","aka":["ERSPC","European Randomized Study of Screening for Prostate Cancer","European Randomised Study of Screening for Prostate Cancer"],"tldr":"The trial that showed PSA screening does stop some men dying of prostate cancer, and showed at the same time how many men have to be tested, and how many treated for a cancer that was never going to harm them, to achieve it.","summary":"ERSPC identified 182,000 men aged 50 to 74 through population registries in seven European countries in the early 1990s and randomised them to an offer of prostate-specific antigen screening, on average once every four years, or to a control group that was not offered it. The predefined core age group was 162,243 men aged 55 to 69. Eighty-two percent of the men offered screening accepted at least one round.\n\nAt a median of nine years the cumulative incidence of prostate cancer was 8.2 percent in the screened group against 4.8 percent in the control group, and the rate ratio for death from prostate cancer was 0.80. The absolute difference was 0.71 deaths per 1,000 men, which the authors expressed as 1,410 men needing to be screened and 48 additional cancers needing to be treated to prevent one death.\n\nThe 16-year report, on 182,160 men with a core group of 162,389, found the same rate ratio with a tighter interval and a larger absolute benefit: the absolute mortality difference grew from 0.14 percent at 13 years to 0.18 percent at 16, the number needed to invite fell from 742 to 570 and the number needed to diagnose from 26 to 18. Those two sets of figures use different denominators, men invited against men screened, which is the commonest way this trial is misquoted.","status":"positive","asOf":"2026-09-25","links":[{"label":"ERSPC at 9 years (New England Journal of Medicine 2009)","url":"https://doi.org/10.1056/NEJMoa0810084"},{"label":"ERSPC at 16 years (European Urology 2019)","url":"https://doi.org/10.1016/j.eururo.2019.02.009"},{"label":"ISRCTN registry ISRCTN49127736","url":"https://www.isrctn.com/ISRCTN49127736"}],"tags":[],"related":[],"cancers":["prostate","prostate-low-risk","prostate-intermediate-risk","prostate-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["psa","overdiagnosis"],"trials":["plco-prostate","goteborg-2","protect"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN49127736","phase":"3","setting":"Population screening: men aged 50 to 74 identified from population registries and randomised to an offer of PSA screening about every four years or to no offer, with death from prostate cancer as the primary outcome in a predefined core age group of men aged 55 to 69","sponsor":"Erasmus MC with the ERSPC collaborating centres in eight European countries","result":"Rate ratio for prostate cancer death 0.80 (95 percent confidence interval 0.65 to 0.98, adjusted p=0.04) at a median of nine years, and 0.80 (0.72 to 0.89, p<0.001) at 16 years; 1,410 screened and 48 extra cancers treated per death prevented at nine years, 570 invited and 18 diagnosed at 16 years.","yearReported":2019,"enrolledBasis":"registry","outcomes":[{"endpoint":"Death from prostate cancer, core age group 55 to 69, median 9 years","primary":true,"unit":"rate ratio","arms":[{"name":"Offered PSA screening","value":0.8,"note":"Absolute risk difference 0.71 deaths per 1,000 men; 1,410 needed to screen and 48 extra cancers treated to prevent one death. Among men who attended the first round the rate ratio was 0.73 (0.56 to 0.90)."}],"ci":[0.65,0.98],"p":"0.04","source":"https://doi.org/10.1056/NEJMoa0810084"},{"endpoint":"Death from prostate cancer, core age group, 16 years","unit":"rate ratio","arms":[{"name":"Offered PSA screening","value":0.8,"note":"Number needed to invite 570, number needed to diagnose 18, against 742 and 26 at 13 years; absolute mortality difference 0.18 percent."}],"ci":[0.72,0.89],"p":"<0.001","source":"https://doi.org/10.1016/j.eururo.2019.02.009"},{"endpoint":"Cumulative incidence of prostate cancer, median 9 years","unit":"%","arms":[{"name":"Offered PSA screening","value":8.2},{"name":"Control","value":4.8}],"source":"https://doi.org/10.1056/NEJMoa0810084"}],"replication":"PLCO, running at the same time in the United States, found no mortality difference, but roughly half its control group was screened outside the trial, so the two trials compared organised screening with opportunistic screening rather than with none. CAP, the cluster-randomised trial of a single PSA invitation in UK general practice, found no mortality reduction at 15 years."},{"id":"nct02890602","kind":"trial","name":"Erythropoietin for Management of Anemia Caused by Chemotherapy","aka":[],"tldr":"A phase 2 trial of Darbepoetin alfa, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone in Diffuse large B-cell lymphoma, run by Kosin University Gospel Hospital, completed.","summary":"Erythropoietin for Management of Anemia Caused by Chemotherapy is a phase 2 interventional study registered as NCT02890602 by Kosin University Gospel Hospital, with 53 participants recorded, started 2012-09-01 and reaching its primary completion in 2017-11-28. Interventions recorded: Darbepoetin alfa, R-CHOP. Conditions recorded: Diffuse Large B-cell Lymphoma.\n\nLinked to the drug Darbepoetin alfa because the registry names it among its interventions and Diffuse large B-cell lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02890602","url":"https://clinicaltrials.gov/study/NCT02890602"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["darbepoetin-alfa","rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02890602","phase":"2","setting":"A Phase Ⅱ Study of Erythropoietin for Management of Anemia Caused by Chemotherapy in Patients With Diffuse Large B-cell Lymphoma","sponsor":"Kosin University Gospel Hospital","started":"2012-09-01","enrolled":53,"enrolledBasis":"registry","outcomes":[]},{"id":"escort-1st","kind":"trial","name":"ESCORT-1st","aka":[],"tldr":"ESCORT-1st is China's first-line immunotherapy trial for squamous oesophageal cancer, one of five that together made chemo-immunotherapy the global standard.","summary":"ESCORT-1st, trial NCT03691090 sponsored by Jiangsu Hengrui and published in JAMA in 2021, is China's first-line immunotherapy trial for advanced oesophageal squamous cell carcinoma, one of five concordant trials that together made chemo-immunotherapy the global standard. It randomised 596 patients to camrelizumab or placebo with paclitaxel and cisplatin and met its primary overall survival endpoint, confirmed at the final analysis in 2024; camrelizumab is approved in China for the disease but not in the United States, and the later ESCORT-NEO trial showed neoadjuvant camrelizumab plus chemotherapy raises pathologic complete response in resectable disease. OnCo links it to oesophageal cancer, PD-1 as a target, camrelizumab, Jing Huang and Rui-Hua Xu. Whether Chinese PD-1 antibodies reach patients outside China for this indication is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03691090","url":"https://clinicaltrials.gov/study/NCT03691090"},{"label":"JAMA 2021","url":"https://jamanetwork.com/journals/jama/fullarticle/2784143"}],"tags":[],"related":[],"cancers":["esophageal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["camrelizumab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["huang-jing-cams","xu-rui-hua"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03691090","phase":"3","setting":"First-line advanced oesophageal squamous cell carcinoma (China): camrelizumab + paclitaxel/cisplatin vs placebo + chemotherapy","sponsor":"Jiangsu Hengrui","result":"OS 15.3 vs 12.0 months, HR 0.70.","started":"2018-12-03","startedType":"actual","yearReported":2021,"enrolled":596,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Camrelizumab + chemotherapy","n":298,"value":15.3},{"name":"Placebo + chemotherapy","n":298,"value":12}],"hr":0.7,"source":"https://jamanetwork.com/journals/jama/fullarticle/2784143"}],"replication":"One of five concordant first-line ESCC chemo-IO trials."},{"id":"esopec","kind":"trial","name":"ESOPEC","aka":[],"tldr":"ESOPEC pitted the two standard ways of treating operable oesophageal adenocarcinoma against each other, chemotherapy before and after surgery or chemoradiotherapy before it, and found that the chemotherapy approach helped people live longer.","summary":"ESOPEC was a German multicentre phase 3 trial of 438 patients with resectable adenocarcinoma of the oesophagus or gastro-oesophageal junction, randomised to perioperative FLOT (four cycles before and four after surgery) or to the CROSS regimen of carboplatin and paclitaxel with 41.4 Gy of radiotherapy followed by surgery. The primary endpoint was overall survival.\n\nPerioperative FLOT lengthened overall survival compared with neoadjuvant chemoradiotherapy, with a similar rate of complete resection and postoperative complications. The result, reported in 2024 and published in 2025, tipped guidelines towards perioperative chemotherapy for adenocarcinoma of the oesophagus, and the trials adding immunotherapy to FLOT build on it.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02509286","url":"https://clinicaltrials.gov/study/NCT02509286"}],"tags":["subtype-trials"],"related":[],"cancers":["oesophageal-adenocarcinoma","esophageal"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","leucovorin","oxaliplatin","docetaxel","carboplatin","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jens-hoeppner"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02509286","phase":"3","setting":"Resectable oesophageal adenocarcinoma: perioperative FLOT chemotherapy against CROSS neoadjuvant chemoradiotherapy, each followed by surgery","sponsor":"University Hospital Schleswig-Holstein","result":"Perioperative FLOT improved overall survival compared with CROSS chemoradiotherapy in resectable oesophageal adenocarcinoma.","started":"2016-01","yearReported":2024,"enrolled":438,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Perioperative FLOT + surgery","n":221,"value":57.4,"note":"Median follow-up 55 months"},{"name":"Preoperative chemoradiotherapy (41.4 Gy, carboplatin-paclitaxel) + surgery","n":217,"value":50.7}],"hr":0.7,"ci":[0.53,0.92],"p":"0.01","source":"https://doi.org/10.1056/nejmoa2409408"},{"endpoint":"Progression-free survival at 3 years","unit":"%","arms":[{"name":"Perioperative FLOT + surgery","n":221,"value":51.6},{"name":"Preoperative chemoradiotherapy (41.4 Gy, carboplatin-paclitaxel) + surgery","n":217,"value":35}],"hr":0.66,"ci":[0.51,0.85],"source":"https://doi.org/10.1056/nejmoa2409408"},{"endpoint":"Mortality at 90 days after surgery","unit":"%","arms":[{"name":"Perioperative FLOT + surgery","value":3.1},{"name":"Preoperative chemoradiotherapy (41.4 Gy, carboplatin-paclitaxel) + surgery","value":5.6}],"source":"https://doi.org/10.1056/nejmoa2409408"}]},{"id":"espac-1","kind":"trial","name":"ESPAC-1","aka":["ESPAC1","European Study Group for Pancreatic Cancer trial 1"],"tldr":"ESPAC-1 is the 2004 trial that made chemotherapy after pancreatic cancer surgery standard and pushed radiotherapy out: five-year survival was 21 percent with chemotherapy against 8 percent without, while chemoradiotherapy lowered it from 20 to 10 percent.","summary":"ESPAC-1 randomised 289 patients with resected pancreatic ductal adenocarcinoma in a two-by-two factorial design; the final analysis (median follow-up 47 months, 237 deaths) gave an estimated five-year survival of 21 percent among patients who received chemotherapy against 8 percent among those who did not (p 0.009), and 10 percent among those who received chemoradiotherapy against 20 percent among those who did not (p 0.05), the chemotherapy benefit persisting after adjustment for prognostic factors. The authors concluded that adjuvant chemotherapy has a significant survival benefit whereas adjuvant chemoradiotherapy is deleterious, a conclusion that separated European practice (chemotherapy alone: ESPAC-3, ESPAC-4, PRODIGE 24) from the North American use of adjuvant chemoradiotherapy for a decade and that the negative LAP07 and CONKO-007 results later echoed in the locally advanced setting. Its split-course 20 Gy radiotherapy and lack of quality assurance were criticised at the time, but no later randomised trial has shown adjuvant chemoradiotherapy improves survival.","status":"mixed","asOf":"2026-09-24","links":[{"label":"Neoptolemos et al., a randomised trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer, ESPAC-1 (NEJM 2004)","url":"https://doi.org/10.1056/NEJMoa032295"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","chemoradiation"],"targets":[],"drugs":["fluorouracil","leucovorin"],"companies":[],"institutions":["cruk"],"pathways":[],"terms":["neoadjuvant-adjuvant","chemoradiation","pancreatic-failed-programmes"],"trials":["espac-3","espac-4","conko-001"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Resected pancreatic ductal adenocarcinoma in Europe: a two-by-two factorial randomisation to adjuvant chemoradiotherapy (20 Gy over two weeks with fluorouracil), adjuvant chemotherapy (fluorouracil and folinic acid), both, or observation, with overall survival as the primary endpoint","sponsor":"European Study Group for Pancreatic Cancer (University of Liverpool), Cancer Research UK","result":"Five-year survival 21 percent with adjuvant chemotherapy against 8 percent without (p 0.009); 10 percent with chemoradiotherapy against 20 percent without (p 0.05).","yearReported":2004,"enrolled":289,"enrolledBasis":"randomised","enrolledNote":"ESPAC-1 predates the trial registries and has no ClinicalTrials.gov or ISRCTN record; 289 is the number randomised in the two-by-two factorial design reported in the NEJM 2004 final analysis (73 chemoradiotherapy, 75 chemotherapy, 72 both, 69 observation).","outcomes":[{"endpoint":"Overall survival at 5 years, chemotherapy factor","primary":true,"unit":"%","arms":[{"name":"Adjuvant fluorouracil and folinic acid (with or without chemoradiotherapy)","n":147,"value":21},{"name":"No chemotherapy","n":142,"value":8}],"p":"0.009","source":"https://doi.org/10.1056/NEJMoa032295"},{"endpoint":"Overall survival at 5 years, chemoradiotherapy factor","unit":"%","arms":[{"name":"Adjuvant chemoradiotherapy (with or without chemotherapy)","n":145,"value":10},{"name":"No chemoradiotherapy","n":144,"value":20}],"p":"0.05","source":"https://doi.org/10.1056/NEJMoa032295"}]},{"id":"espac-3","kind":"trial","name":"ESPAC-3","aka":["ESPAC-3 (v2)","ESPAC3"],"tldr":"ESPAC-3 compared the two adjuvant chemotherapies then available after pancreatic cancer surgery and found they gave the same survival, about 23 months, but gemcitabine caused half as many serious side effects; a companion cohort in ampullary and bile duct cancers is still the main randomised evidence for adjuvant chemotherapy in those rarer tumours.","summary":"ESPAC-3 was the European Study Group for Pancreatic Cancer's phase 3 trial at 159 centres in Europe, Australasia, Japan and Canada. After ESPAC-1 established adjuvant chemotherapy, the observation arm was removed and 1,088 patients with resected pancreatic ductal adenocarcinoma were randomised to six months of fluorouracil with folinic acid or gemcitabine. The primary endpoint was overall survival.\n\nMedian survival was 23.0 months with fluorouracil and 23.6 months with gemcitabine (hazard ratio 0.94), with no difference in progression-free survival or quality of life, but treatment-related serious adverse events were twice as common with fluorouracil (14 against 7.5 percent). A periampullary cohort of 428 patients randomised between observation and the two regimens showed a survival benefit for chemotherapy after adjustment for prognostic factors, which is why the corpus's ampullary cancer page cites ESPAC-3 as its adjuvant evidence.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00058201","url":"https://clinicaltrials.gov/study/NCT00058201"}],"tags":["soc-trials"],"related":[],"cancers":["resectable-pdac","pancreatic","ampullary"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","leucovorin","gemcitabine"],"companies":[],"institutions":["liverpool-hpb-centre"],"pathways":[],"terms":[],"trials":[],"people":["paula-ghaneh","bill-greenhalf"],"bottlenecks":[],"keyPapers":["paper-espac-3-fluorouracil-vs-gemcitabine-adjuvant-neoptolemos-jama-2010"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00058201","phase":"3","setting":"Resected pancreatic ductal adenocarcinoma (and a separate periampullary cohort): six months of adjuvant fluorouracil with folinic acid against gemcitabine, with overall survival as the primary endpoint; an observation arm was dropped when ESPAC-1 showed chemotherapy helped","sponsor":"Royal Liverpool University Hospital","result":"Median overall survival 23.0 months with fluorouracil plus folinic acid against 23.6 months with gemcitabine (hazard ratio 0.94, p 0.39); treatment-related serious adverse events 14 against 7.5 percent.","started":"2001-07","yearReported":2010,"enrolled":1088,"enrolledBasis":"randomised","enrolledNote":"The registry gives an estimated 1,030; the JAMA report randomised 1,088 patients with pancreatic ductal adenocarcinoma (551 to fluorouracil plus folinic acid, 537 to gemcitabine) between 2000 and 2007, and a separate periampullary cohort of 428 was reported in 2012.","outcomes":[{"endpoint":"Overall survival, pancreatic ductal adenocarcinoma cohort","primary":true,"unit":"months","arms":[{"name":"Adjuvant fluorouracil + folinic acid","n":551,"value":23,"note":"95% CI 21.1 to 25.0; median follow-up 34.2 months"},{"name":"Adjuvant gemcitabine","n":537,"value":23.6,"note":"95% CI 21.4 to 26.4"}],"hr":0.94,"ci":[0.81,1.08],"p":"0.39","source":"https://doi.org/10.1001/jama.2010.1275"},{"endpoint":"Patients with treatment-related serious adverse events","unit":"%","arms":[{"name":"Adjuvant fluorouracil + folinic acid","n":551,"value":14},{"name":"Adjuvant gemcitabine","n":537,"value":7.5}],"p":"<0.001","source":"https://doi.org/10.1001/jama.2010.1275"}]},{"id":"espac-4","kind":"trial","name":"ESPAC-4","aka":["ESPAC4"],"tldr":"ESPAC-4 showed that adding the tablet capecitabine to gemcitabine after pancreatic cancer surgery lengthened median survival from 25.5 to 28 months, and the pair became the adjuvant standard for people who cannot tolerate the harsher FOLFIRINOX regimen.","summary":"ESPAC-4 was an open-label phase 3 trial of the European Study Group for Pancreatic Cancer at 92 hospitals, randomising 730 analysed patients with resected pancreatic ductal adenocarcinoma to six cycles of gemcitabine or gemcitabine with capecitabine. The primary endpoint was overall survival.\n\nMedian overall survival was 28.0 months with the combination against 25.5 months with gemcitabine alone (hazard ratio 0.82), with 608 grade 3 to 4 adverse events in 226 patients on the combination against 481 in 196 patients on gemcitabine. The combination became a standard adjuvant option, later placed behind modified FOLFIRINOX (PRODIGE 24) for fit patients, which is how the corpus's resectable pancreatic cancer page cites it. The trial is registered only with the ISRCTN registry.","status":"positive","asOf":"2026-09-22","links":[{"label":"ISRCTN96397434","url":"https://www.isrctn.com/ISRCTN96397434"},{"label":"Palmer et al., ESPAC4 long-term outcomes (JCO 2025)","url":"https://doi.org/10.1200/JCO.24.01118"},{"label":"NICE NG85 recommendation 1.8.6","url":"https://www.nice.org.uk/guidance/ng85/chapter/Recommendations"}],"tags":["soc-trials"],"related":[],"cancers":["resectable-pdac","pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","capecitabine"],"companies":[],"institutions":["liverpool-hpb-centre"],"pathways":[],"terms":["pancreatic-cancer-uk-drug-access"],"trials":["prodige-24","apact","jaspac-01"],"people":["paula-ghaneh","daniel-palmer"],"bottlenecks":[],"keyPapers":["paper-espac-4-gemcitabine-capecitabine-adjuvant-pancreatic-lancet-2017"],"journals":[],"dependsOn":[],"notes":["Long-term outcomes (JCO 2025, Palmer et al.; median follow-up 104 months, 566 deaths): median overall survival 31.6 months with gemcitabine plus capecitabine against 28.4 months with gemcitabine (hazard ratio 0.83, 0.71 to 0.98; p 0.031); after R0 resection 49.9 against 32.2 months (hazard ratio 0.63; p 0.002); five-year survival in node-negative patients 59 against 53 percent (hazard ratio 0.63; p 0.04) with no significant difference in node-positive patients; the 193 patients (26.4 percent) who would not have been eligible for PRODIGE 24 still benefited (25.9 against 20.7 months, hazard ratio 0.71; p 0.038). The authors conclude gemcitabine plus capecitabine is the standard for people not eligible for modified FOLFIRINOX, which is NICE NG85's recommendation 1.8.6 for England."],"nct":"ISRCTN96397434","phase":"3","setting":"Resected pancreatic ductal adenocarcinoma within 12 weeks of surgery in the United Kingdom, Germany, France and Sweden: six cycles of adjuvant gemcitabine alone against gemcitabine plus capecitabine, with overall survival as the primary endpoint","sponsor":"University of Liverpool (Cancer Research UK)","result":"Median overall survival 28.0 months with gemcitabine plus capecitabine against 25.5 months with gemcitabine alone (hazard ratio 0.82, p 0.032).","yearReported":2017,"enrolled":732,"enrolledBasis":"registered","enrolledNote":"ESPAC-4 has no ClinicalTrials.gov record; the figure is the 732 enrolled in the Lancet report, of whom 730 were analysed (366 gemcitabine, 364 gemcitabine plus capecitabine); the trial is registered as ISRCTN96397434.","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Adjuvant gemcitabine + capecitabine","n":364,"value":28,"note":"95% CI 23.5 to 31.5"},{"name":"Adjuvant gemcitabine","n":366,"value":25.5,"note":"95% CI 22.7 to 27.9"}],"hr":0.82,"ci":[0.68,0.98],"p":"0.032","source":"https://doi.org/10.1016/S0140-6736(16)32409-6"},{"endpoint":"Patients with grade 3 to 4 adverse events","unit":"%","arms":[{"name":"Adjuvant gemcitabine + capecitabine","n":359,"value":63,"note":"226 of 359 patients, 608 events"},{"name":"Adjuvant gemcitabine","n":366,"value":54,"note":"196 of 366 patients, 481 events"}],"source":"https://doi.org/10.1016/S0140-6736(16)32409-6"},{"endpoint":"Overall survival, long-term follow-up (median 104 months)","unit":"months","arms":[{"name":"Adjuvant gemcitabine + capecitabine","n":365,"value":31.6,"note":"95% CI 26.5 to 38.0"},{"name":"Adjuvant gemcitabine","n":367,"value":28.4,"note":"95% CI 25.2 to 32.0"}],"hr":0.83,"ci":[0.71,0.98],"p":"0.031","source":"https://doi.org/10.1200/JCO.24.01118"},{"endpoint":"Overall survival after R0 resection (long-term)","unit":"months","arms":[{"name":"Adjuvant gemcitabine + capecitabine","value":49.9,"note":"95% CI 39.0 to 82.3"},{"name":"Adjuvant gemcitabine","value":32.2,"note":"95% CI 27.9 to 41.6"}],"hr":0.63,"ci":[0.47,0.84],"p":"0.002","source":"https://doi.org/10.1200/JCO.24.01118"}]},{"id":"espac-5","kind":"trial","name":"ESPAC-5","aka":["ESPAC5","ESPAC-5F"],"tldr":"ESPAC-5 randomised people whose pancreatic cancer sat on the border of being removable between going straight to surgery and having two months of chemotherapy or chemoradiotherapy first; those treated first were far more likely to be alive a year later, 78 to 84 percent with chemotherapy against 39 percent with immediate surgery, which supports treating before operating in borderline disease.","summary":"ESPAC-5 was a four-arm randomised phase 2 feasibility trial of the European Study Group for Pancreatic Cancer at 16 sites, randomising 90 patients with borderline resectable pancreatic cancer to immediate surgery (33), or two months of neoadjuvant gemcitabine plus capecitabine (20), FOLFIRINOX (20) or capecitabine-based chemoradiotherapy (17), each followed by surgery and adjuvant chemotherapy. The primary endpoints were recruitment rate and resection rate.\n\nResection rates were similar (68 percent after immediate surgery, 55 percent after neoadjuvant therapy) and R0 rates low in both (14 and 23 percent), but one-year overall survival was 39 percent with immediate surgery against 78 percent with gemcitabine plus capecitabine, 84 percent with FOLFIRINOX and 60 percent with chemoradiotherapy, and one-year disease-free survival from surgery was 33 against 59 percent (hazard ratio 0.53). The corpus's borderline resectable pancreatic cancer page cites ESPAC-5 with PREOPANC for neoadjuvant treatment and restaging before surgery.","status":"positive","asOf":"2026-09-22","links":[{"label":"Lancet Gastroenterol Hepatol 2023","url":"https://doi.org/10.1016/S2468-1253(22)00348-X"},{"label":"ISRCTN89500674: ESPAC-5, European Study Group for Pancreatic Cancer trial 5","url":"https://www.isrctn.com/ISRCTN89500674"}],"tags":["soc-trials"],"related":[],"cancers":["borderline-resectable-pdac","pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["gemcitabine","capecitabine","folfirinox"],"companies":[],"institutions":["liverpool-hpb-centre"],"pathways":[],"terms":[],"trials":["alliance-a021501","preopanc-2"],"people":["paula-ghaneh","daniel-palmer","chris-halloran"],"bottlenecks":[],"keyPapers":["paper-espac-5-neoadjuvant-borderline-resectable-pancreatic-lancet-gastro-hep-2023"],"journals":[],"dependsOn":[],"notes":["Registry: ESPAC-5 is registered with the ISRCTN registry as ISRCTN89500674 (found in the ISRCTN search of 24 September 2026); it has no ClinicalTrials.gov record."],"nct":"ISRCTN89500674","phase":"2","setting":"Borderline resectable pancreatic cancer in the United Kingdom and Germany: immediate surgery against short-course neoadjuvant gemcitabine plus capecitabine, FOLFIRINOX or capecitabine-based chemoradiotherapy, each followed by surgery and adjuvant chemotherapy, with recruitment and resection rate as the primary endpoints of a four-arm feasibility trial","sponsor":"University of Liverpool (Cancer Research UK)","result":"One-year overall survival 39 percent with immediate surgery against 78 percent with neoadjuvant gemcitabine plus capecitabine, 84 percent with FOLFIRINOX and 60 percent with chemoradiotherapy (p 0.0028); resection rates similar (68 against 55 percent).","yearReported":2023,"enrolled":90,"enrolledBasis":"randomised","enrolledNote":"ESPAC-5 has no ClinicalTrials.gov record and the Lancet Gastroenterology and Hepatology report does not print a registry id; the figure is the 90 patients randomised between 2014 and 2018 (86 analysed).","outcomes":[{"endpoint":"Resection rate","primary":true,"unit":"%","arms":[{"name":"Immediate surgery","n":31,"value":68,"note":"21 of 31"},{"name":"Neoadjuvant therapy arms combined","n":55,"value":55,"note":"30 of 55"}],"p":"0.33","source":"https://doi.org/10.1016/S2468-1253(22)00348-X"},{"endpoint":"Overall survival at 1 year","unit":"%","arms":[{"name":"Immediate surgery","n":31,"value":39,"note":"95% CI 24 to 61"},{"name":"Neoadjuvant gemcitabine + capecitabine","n":19,"value":78,"note":"95% CI 60 to 100"},{"name":"Neoadjuvant FOLFIRINOX","n":20,"value":84,"note":"95% CI 70 to 100"},{"name":"Neoadjuvant capecitabine-based chemoradiotherapy","n":16,"value":60,"note":"95% CI 37 to 97"}],"p":"0.0028","source":"https://doi.org/10.1016/S2468-1253(22)00348-X"},{"endpoint":"Disease-free survival at 1 year from surgery","unit":"%","arms":[{"name":"Immediate surgery","value":33,"note":"95% CI 19 to 58"},{"name":"Neoadjuvant therapy arms combined","value":59,"note":"95% CI 46 to 74"}],"hr":0.53,"ci":[0.28,0.98],"p":"0.016","source":"https://doi.org/10.1016/S2468-1253(22)00348-X"},{"endpoint":"R0 resection among resected patients","unit":"%","arms":[{"name":"Immediate surgery","n":21,"value":14},{"name":"Neoadjuvant therapy arms combined","n":30,"value":23}],"p":"0.49","source":"https://doi.org/10.1016/S2468-1253(22)00348-X"}]},{"id":"esphall","kind":"trial","name":"EsPhALL (EsPhALL2004 and EsPhALL2010)","aka":["EsPhALL","ESPHALL","EsPhALL2004","EsPhALL2010"],"tldr":"EsPhALL is the European intergroup study that brought the leukaemia pill imatinib into treatment for children with Philadelphia-positive acute lymphoblastic leukaemia; the first version gave it in short bursts after induction and the second gave it continuously, and together they set the chemotherapy backbone that the standard of care still uses.","summary":"EsPhALL was an intergroup study across ten European groups, Chile and Hong Kong for children with Philadelphia chromosome-positive acute lymphoblastic leukaemia identified on national front-line trials. In EsPhALL2004 (2004 to 2009) good-risk patients, defined by early response, were randomised to post-induction imatinib with chemotherapy or chemotherapy alone, and all poor-risk patients received imatinib; the backbone was a Berlin-Frankfurt-Munster high-risk regimen with transplant after four post-induction blocks. Four-year disease-free survival in good-risk patients was 72.9 percent with imatinib against 61.7 percent without, a difference that was not statistically significant in the intention-to-treat analysis, and four-year event-free survival in poor-risk patients was 53.5 percent.\n\nEsPhALL2010 (2010 to 2014) gave imatinib continuously from day 15 of induction and through chemotherapy, with transplant reserved for poor early responders: 155 patients had five-year event-free survival of 57.0 percent and overall survival of 71.8 percent, similar to EsPhALL2004 despite transplanting fewer patients, at the cost of more toxicity during intensive blocks. The paediatric Philadelphia-positive leukaemia page describes imatinib given through induction and continued throughout EsPhALL-type chemotherapy on this evidence.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00287105","url":"https://clinicaltrials.gov/study/NCT00287105"}],"tags":["soc-trials"],"related":[],"cancers":["all-paediatric-ph-positive","all-leukemia","leukaemia"],"sections":[],"technologies":["kinase-inhibitors","cytotoxic-chemotherapy","allogeneic-hsct"],"targets":[],"drugs":["imatinib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-esphall-imatinib-biondi-lancet-oncol-2012","paper-esphall2010-continuous-imatinib-biondi-lancet-haematol-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00287105","phase":"2","setting":"Children and adolescents aged 1 to 17 with Philadelphia chromosome-positive acute lymphoblastic leukaemia treated on national front-line trials: imatinib with a BFM high-risk chemotherapy backbone and transplant for the higher-risk, first as short discontinuous courses after induction (EsPhALL2004, randomised in good-risk patients) and then continuously from day 15 of induction (EsPhALL2010, single arm)","sponsor":"Rennes University Hospital","result":"Imatinib with BFM chemotherapy gave four-year disease-free survival of 72.9 percent against 61.7 percent without imatinib in good-risk children (not significant); continuous imatinib from day 15 in EsPhALL2010 gave five-year event-free survival of 57.0 percent and overall survival of 71.8 percent with fewer transplants.","started":"2005-12","startedType":"actual","yearReported":2018,"enrolled":178,"enrolledBasis":"registered","enrolledNote":"The registry lists 49 patients because most were registered through their national front-line trials; the EsPhALL2004 report enrolled 178 patients (108 good risk, 70 poor risk) and the single-arm EsPhALL2010 amendment a further 155.","outcomes":[{"endpoint":"Disease-free survival at 4 years, good-risk patients (EsPhALL2004)","primary":true,"unit":"%","arms":[{"name":"Post-induction imatinib + chemotherapy","n":46,"value":72.9,"note":"95% CI 56.1 to 84.1"},{"name":"Chemotherapy alone","n":44,"value":61.7,"note":"95% CI 45.0 to 74.7"}],"hr":0.63,"ci":[0.28,1.41],"p":"0.24","source":"https://doi.org/10.1016/S1470-2045(12)70377-7"},{"endpoint":"Event-free survival at 4 years, poor-risk patients (EsPhALL2004, all given imatinib)","primary":true,"unit":"%","arms":[{"name":"Post-induction imatinib + chemotherapy","n":70,"value":53.5,"note":"95% CI 40.4 to 65.0"}],"source":"https://doi.org/10.1016/S1470-2045(12)70377-7"},{"endpoint":"Event-free survival at 5 years (EsPhALL2010, continuous imatinib)","primary":true,"unit":"%","arms":[{"name":"Imatinib from day 15 of induction + chemotherapy","n":155,"value":57,"note":"95% CI 48.5 to 64.6; 38% transplanted in first remission"}],"source":"https://doi.org/10.1016/S2352-3026(18)30173-X"},{"endpoint":"Overall survival at 5 years (EsPhALL2010, continuous imatinib)","primary":true,"unit":"%","arms":[{"name":"Imatinib from day 15 of induction + chemotherapy","n":155,"value":71.8,"note":"95% CI 63.5 to 78.5"}],"source":"https://doi.org/10.1016/S2352-3026(18)30173-X"}]},{"id":"estimabl2","kind":"trial","name":"ESTIMABL2","aka":[],"tldr":"Proved that most people with small, low-risk thyroid cancers can skip radioactive iodine after surgery without any increase in recurrence.","summary":"ESTIMABL2, trial NCT01837745 sponsored by Gustave Roussy and the French Endocrine Tumour Group and reported in 2022, proved that most people with small, low-risk differentiated thyroid cancers can skip radioactive iodine after total thyroidectomy without any increase in recurrence. It randomised 776 patients with pT1a to T1b, node-negative tumours to no radioiodine or 1.1 GBq ablation and met its non-inferiority endpoint on event-free status at three years, confirmed at five years in 2024. OnCo links it to thyroid cancer, radioiodine therapy, radioactive iodine, the low-risk thyroid cancer term, Gustave Roussy and Martin Schlumberger, and together with IoN and HiLo it removed radioiodine from routine low-risk care in ATA and ESMO guidance; the UK IoN trial reached the same conclusion. Whether the same holds for larger low-risk tumours, as IoN suggested for pT2, is the remaining question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01837745","url":"https://clinicaltrials.gov/study/NCT01837745"},{"label":"NEJM 2022","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2111953"},{"label":"5-year follow-up","url":"https://www.thelancet.com/journals/landia/article/PIIS2213-8587(24)00276-6/fulltext"}],"tags":[],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["radioiodine-therapy"],"targets":[],"drugs":[],"companies":[],"institutions":["gustave-roussy"],"pathways":[],"terms":["low-risk-dtc"],"trials":[],"people":["martin-schlumberger"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01837745","phase":"3","setting":"Low-risk differentiated thyroid cancer (pT1a-T1b N0/Nx) after total thyroidectomy: no radioiodine vs 1.1 GBq ablation","sponsor":"Gustave Roussy / French Endocrine Tumour Group","result":"3-year event-free 95.6% vs 95.9% (non-inferior).","started":"2013-05-13","startedType":"actual","yearReported":2022,"enrolled":776,"enrolledBasis":"registry","outcomes":[{"endpoint":"Patients without events at 3 years","primary":true,"unit":"%","arms":[{"name":"No radioiodine","value":95.6},{"name":"Radioiodine 1.1 GBq","value":95.9}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2111953"}],"replication":"IoN (UK, Lancet 2025) reached the same conclusion in a pooled analysis."},{"id":"nct04634357","kind":"trial","name":"ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma","aka":["ARYA-2"],"tldr":"A phase 1/2 trial of ET140203 T Cells in hepatoblastoma and hepatocellular carcinoma, run by Eureka Therapeutics Inc., now recruiting.","summary":"ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma is a phase 1/2 interventional study registered as NCT04634357 by Eureka Therapeutics Inc., with 12 participants planned, started 2022-07-19 and due to reach its primary completion in 2027-12-31. Interventions recorded: ET140203 T Cells.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04634357","url":"https://clinicaltrials.gov/study/NCT04634357"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hepatoblastoma","hcc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["eureka-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04634357","phase":"1/2","setting":"An Open-Label, Dose Escalation, Phase I/II Clinical Trial of ET140203 T Cells in Pediatric Subjects With Relapsed/Refractory Hepatoblastoma (HB), Hepatocellular Neoplasm-Not Otherwise Specified (HCN-NOS), or Hepatocellular Carcinoma (HCC)","sponsor":"Eureka Therapeutics Inc.","started":"2022-07-19","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"euramos-1","kind":"trial","name":"EURAMOS-1","aka":[],"tldr":"The largest osteosarcoma trial ever run, across four cooperative groups on two continents. Neither adding interferon for good responders nor adding ifosfamide and etoposide for poor responders improved outcomes, so three-drug MAP chemotherapy remained the standard and the field turned to new biology.","summary":"2,260 patients registered from 325 sites in 17 countries between 2005 and 2011. Poor responders (at least 10% viable tumour after MAP induction; 618 randomised) had identical event-free survival with MAPIE versus MAP (HR 0.98) and substantially more toxicity (Marina et al., Lancet Oncol 2016). Good responders (716 randomised) had no significant EFS gain from maintenance pegylated interferon alfa-2b, with 3-year EFS 76% overall and a large proportion never starting or stopping interferon early (Bielack et al., JCO 2015). EURAMOS-1 defined MAP (high-dose methotrexate, doxorubicin, cisplatin) as the international standard, showed that intensifying chemotherapy on the basis of histological response does not help, and demonstrated that four national groups could run one protocol. Its biobank underpins later genomic work on osteosarcoma.","status":"negative","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT00134030","url":"https://clinicaltrials.gov/study/NCT00134030"},{"label":"Marina et al., Lancet Oncology 2016 (poor responders)","url":"https://doi.org/10.1016/S1470-2045(16)30214-5"},{"label":"Bielack et al., JCO 2015 (good responders)","url":"https://doi.org/10.1200/JCO.2014.60.0734"}],"tags":["nci-coverage","paediatric","bone","lesson:intensification-without-benefit"],"related":[],"cancers":["osteosarcoma"],"sections":[],"technologies":["limb-salvage-surgery","cytotoxic-chemotherapy"],"targets":[],"drugs":["methotrexate","doxorubicin","cisplatin","ifosfamide","etoposide","interferon-alfa"],"companies":["childrens-oncology-group"],"institutions":["siop-europe"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-rare-cancers","b-negative-results"],"keyPapers":["paper-marina-lancet-oncol","paper-bielack-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00134030","phase":"3","setting":"Resectable high-grade osteosarcoma, age up to 40: MAP induction, then randomisation by histological response (good responders: MAP vs MAP + pegylated interferon alfa-2b; poor responders: MAP vs MAPIE with ifosfamide and etoposide)","sponsor":"Children's Oncology Group, COSS, EOI and SSG (EURAMOS collaboration)","result":"Poor responders: EFS HR 0.98 for MAPIE vs MAP, more toxicity. Good responders: no EFS benefit from interferon.","started":"2005-11-14","startedType":"actual","yearReported":2016,"enrolled":2260,"enrolledBasis":"registered","enrolledNote":"ClinicalTrials.gov lists 1,334 participants (actual), the patients randomised (618 poor responders and 716 good responders); the Lancet Oncology 2016 paper reports 2,260 patients registered from 325 sites in 17 countries.","outcomes":[{"endpoint":"Event-free survival, poor responders (MAPIE vs MAP)","primary":true,"arms":[{"name":"MAPIE","n":310,"note":"154 events"},{"name":"MAP","n":308,"note":"153 events"}],"hr":0.98,"source":"https://doi.org/10.1016/S1470-2045(16)30214-5"},{"endpoint":"3-year event-free survival, good responders (all randomised)","unit":"%","arms":[{"name":"MAP with or without interferon alfa-2b","n":716,"value":76}],"source":"https://doi.org/10.1200/JCO.2014.60.0734"}],"replication":"Consistent with the earlier INT-0133 and COSS experience that adding agents to MAP does not improve survival; no subsequent trial has displaced MAP."},{"id":"euro-ewing-2012","kind":"trial","name":"Euro Ewing 2012","aka":[],"tldr":"The American Ewing sarcoma regimen beat the European one in a head-to-head trial, unifying practice.","summary":"Euro Ewing 2012, trial NCT00987636 sponsored by the University of Birmingham and the EuroEwing consortium and published in JCO in 2023, showed that the American Ewing sarcoma regimen, VDC/IE, beat the European VIDE/VAI regimen in a head-to-head trial, unifying practice. It randomised 640 newly diagnosed patients and found better event-free and overall survival with VDC/IE, with less toxicity and a shorter treatment duration, making it the international standard. OnCo links it to sarcomas, doxorubicin, ifosfamide, Douglas S. Hawkins, Uta Dirksen, the Children's Cancer and Leukaemia Group, SIOP Europe and the bottleneck of rare and paediatric cancers without markets. Whether further intensification or new agents can improve on VDC/IE is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00987636","url":"https://clinicaltrials.gov/study/NCT00987636"}],"tags":[],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["doxorubicin","ifosfamide","treosulfan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["douglas-hawkins","uta-dirksen"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00987636","phase":"3","setting":"Newly diagnosed Ewing sarcoma: VDC/IE (US-style) vs VIDE/VAI (European) induction/consolidation","sponsor":"University of Birmingham / EuroEwing consortium","result":"EFS HR 0.71; OS HR 0.62 favouring VDC/IE.","started":"2009-10-01","startedType":"actual","yearReported":2020,"enrolled":640,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"VDC/IE","n":320,"value":67},{"name":"VIDE","n":320,"value":61}],"hr":0.71,"ci":[0.55,0.92],"source":"https://ascopubs.org/doi/10.1200/JCO.22.01651"}]},{"id":"euronet-phl-c2","kind":"trial","name":"EuroNet-PHL-C2","aka":["EuroNet PHL-C2","PHL-C2","EuroNet-PHL-C2 trial"],"tldr":"EuroNet-PHL-C2 is the huge European trial that treats children with Hodgkin lymphoma using PET scans after the first two cycles to decide who can skip radiotherapy, and tests a more intensive chemotherapy consolidation to make that possible for more of them; enrolment of nearly 3,000 children has closed and the full results are awaited.","summary":"EuroNet-PHL-C2 was the second international inter-group study of the European Network for Paediatric Hodgkin Lymphoma, sponsored by the University of Giessen, enrolling 2,921 children and adolescents with classical Hodgkin lymphoma between 2015 and 2024. All patients received OEPA induction (vincristine, etoposide, prednisone, doxorubicin) with an early PET response assessment. Intermediate- and advanced-stage patients were randomised to COPDAC-28 consolidation (cyclophosphamide, vincristine, prednisone, dacarbazine) or the intensified DECOPDAC-21 (adding etoposide and doxorubicin), with radiotherapy omitted in adequate early responders and restricted to residual PET-positive sites otherwise. The primary endpoint is five-year event-free survival.\n\nThe registry records the trial as completed in October 2025 with no posted results, and no primary publication was found on Europe PMC by NCT id, so the record states the design. The corpus's Hodgkin lymphoma page cites the trial for risk-adapted OEPA/COPDAC with PET-guided radiotherapy omission.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02684708","url":"https://clinicaltrials.gov/study/NCT02684708"}],"tags":["soc-trials"],"related":[],"cancers":["hodgkin-lymphoma","childhood-cancers"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["vincristine","etoposide","prednisone","doxorubicin","cyclophosphamide","dacarbazine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02684708","phase":"3","setting":"Classical Hodgkin lymphoma in children and adolescents across Europe: OEPA induction followed by risk-adapted consolidation with COPDAC-28 (standard) or the intensified DECOPDAC-21 (experimental), with PET-guided omission or restriction of radiotherapy","sponsor":"University of Giessen","started":"2015-10-01","startedType":"actual","enrolled":2921,"enrolledBasis":"registry","outcomes":[]},{"id":"europac","kind":"trial","name":"EUROPAC","aka":["European Registry of Familial Pancreatic Cancer and Hereditary Pancreatitis","Europac-PRIME","Europac-PLUS","ISRCTN62546421"],"tldr":"The UK's registry and screening programme for families with inherited pancreatic cancer risk, run from Liverpool since 2000; its 2026 outcomes paper shows risk-stratified surveillance finds four times more actionable lesions.","summary":"EUROPAC registers people with a family history of pancreatic cancer or with hereditary pancreatitis and offers imaging surveillance through its Europac-PRIME arm, with research on secondary screening through Europac-PLUS. The current ISRCTN record (62546421) lists the University of Liverpool as sponsor, recruitment from 1 July 2019 to 1 July 2039, a target of 10,000 and ten UK sites: Royal Liverpool, Glasgow Royal Infirmary, the Freeman in Newcastle, Leeds, Nottingham City, Morriston in Swansea, Bristol Royal Infirmary, Plymouth, Southampton and UCLH. The 2026 European Journal of Cancer outcomes paper reports that 893 asymptomatic individuals started surveillance between January 2000 and April 2025 (median age 52); after Family Risk stratification was introduced in 2020, actionable pancreatic findings rose from 0.8 percent (4 of 508) to 3.6 percent (14 of 385), and operable lesions from 0.6 to 3 percent. NICE NG85 recommends surveillance for hereditary pancreatitis with PRSS1, for BRCA1, BRCA2, PALB2 or CDKN2A carriers with a first-degree relative affected, and for Peutz-Jeghers syndrome; Pancreatic Cancer UK notes that EUROPAC is the route to it.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ISRCTN62546421","url":"https://www.isrctn.com/ISRCTN62546421"},{"label":"Outcomes paper, European Journal of Cancer 2026","url":"https://europepmc.org/article/MED/41740463"},{"label":"Protocol, BMJ Open 2025","url":"https://europepmc.org/article/MED/40180412"},{"label":"Pancreatic Cancer UK: family history","url":"https://www.pancreaticcancer.org.uk/information-and-support/family-history-of-pancreatic-cancer/"}],"tags":["uk","surveillance","familial","pancreatic"],"related":[],"cancers":["pancreatic","ipmn-cystic-precursors"],"sections":["early-detection"],"technologies":[],"targets":["brca","palb2"],"drugs":[],"companies":[],"institutions":["liverpool-hpb-centre","glasgow-royal-infirmary","newcastle-cancer-centre","leeds-cancer-centre","nottingham-cancer-centre","morriston-swansea","bristol-haematology-oncology-centre","derriford-plymouth","southampton-cancer","uclh","pancreatic-cancer-uk"],"pathways":[],"terms":[],"trials":[],"people":["chris-halloran","bill-greenhalf"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN62546421","phase":"observational","setting":"Registry and surveillance programme for people at inherited risk of pancreatic cancer (familial pancreatic cancer, hereditary pancreatitis, BRCA2, PALB2, CDKN2A and other predisposition variants) at ten UK sites; recruiting from July 2019 to July 2039 with a target of 10,000","sponsor":"University of Liverpool","result":"Risk-stratified surveillance (2020 onwards) found actionable pancreatic lesions in 3.6 percent of participants against 0.8 percent before stratification (p = 0.001), and operable lesions in 3 percent against 0.6 percent (European Journal of Cancer 2026).","enrolled":10000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04990609","kind":"trial","name":"EUS-RFA PANCARDINAL-1 Trial","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by The University of Texas Health Science Center, Houston, now recruiting.","summary":"EUS-RFA PANCARDINAL-1 Trial is a phase 2, interventional study registered as NCT04990609 by The University of Texas Health Science Center, Houston, with a registry enrolment figure of 60 participants, started 2021-08-13 and due to reach its primary completion in 2026-12-01. Interventions recorded: Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA); Neoadjuvant Chemotherapy (NAC). Conditions listed: Pancreatic Ductal Adenocarcinoma (PDAC). Primary outcome: Number of participants who are able to complete neoadjuvant chemotherapy plus EUS-RFA and later undergo surgical tumor resection. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04990609","url":"https://clinicaltrials.gov/study/NCT04990609"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04990609","phase":"2","setting":"A Single-arm Phase II Study to Evaluate the Safety and Efficacy of Combination Systematic Chemotherapy and Multiple Rounds of Endoscopic Ultrasound-guided Radiofrequency Ablation in Pancreatic Cancer","sponsor":"The University of Texas Health Science Center, Houston","started":"2021-08-13","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"ev-302","kind":"trial","name":"EV-302 / KEYNOTE-A39","aka":["EV-302","KEYNOTE-A39"],"tldr":"Nearly doubled survival in advanced bladder cancer, ending 40 years of platinum chemotherapy as the standard.","summary":"EV-302, also KEYNOTE-A39, trial NCT04223856 sponsored by Astellas, Pfizer and Merck and published in the New England Journal of Medicine in 2023, nearly doubled survival in first-line advanced urothelial cancer, ending forty years of platinum chemotherapy as the standard. It randomised 886 patients to enfortumab vedotin plus pembrolizumab or platinum with gemcitabine, met both primary endpoints of progression-free and overall survival with very large effects and a much higher response rate, and the extended follow-up in 2025 maintained the survival advantage. It is the template for ADC plus immunotherapy combinations now copied in breast and lung cancer, and how far that template travels is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT04223856","url":"https://clinicaltrials.gov/study/NCT04223856"}],"tags":[],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc"],"targets":["nectin4"],"drugs":["enfortumab-vedotin","pembrolizumab"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["thomas-powles","jonathan-rosenberg","lee-jae-lyun"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04223856","phase":"3","setting":"First-line advanced urothelial cancer: enfortumab vedotin + pembrolizumab vs platinum chemotherapy","sponsor":"Astellas / Pfizer / Merck","result":"OS HR 0.47.","started":"2020-03-30","startedType":"actual","yearReported":2023,"enrolled":886,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Enfortumab vedotin + pembrolizumab","n":442,"value":12.5},{"name":"Platinum + gemcitabine","n":444,"value":6.3}],"hr":0.45,"ci":[0.38,0.54],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2312117"},{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Enfortumab vedotin + pembrolizumab","value":31.5},{"name":"Platinum + gemcitabine","value":16.1}],"hr":0.47,"ci":[0.38,0.58],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2312117"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Enfortumab vedotin + pembrolizumab","value":67.7},{"name":"Platinum + gemcitabine","value":44.4}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2312117"}],"replication":"Confirms EV-103 (phase 1b/2, ORR 68%); the extended follow-up in 2025 maintained the OS hazard ratio."},{"id":"ev-303","kind":"trial","name":"EV-303 / KEYNOTE-905","aka":["EV-303","KEYNOTE-905"],"tldr":"For patients who cannot have cisplatin, the ADC-immunotherapy pair around surgery cut the risk of recurrence or death by 60% and the risk of death by half.","summary":"EV-303, also KEYNOTE-905, trial NCT03924895 sponsored by Astellas, Pfizer and Merck and reported at ESMO 2025 and in the New England Journal of Medicine, showed that for patients with muscle-invasive bladder cancer who cannot have cisplatin, perioperative enfortumab vedotin plus pembrolizumab around cystectomy cut the risk of recurrence or death by sixty percent and the risk of death by half. It randomised 344 patients, met its primary event-free survival endpoint, improved overall survival and raised the pathologic complete response rate from under a tenth to more than half, the largest effect yet seen in a perioperative bladder trial, leading to FDA approval in November 2025. Whether responders can keep their bladders is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03924895","url":"https://clinicaltrials.gov/study/NCT03924895"},{"label":"FDA approval (Nov 2025)","url":"https://www.cancernetwork.com/view/fda-oks-pembrolizumab-enfortumab-vedotin-in-muscle-invasive-bladder-cancer"}],"tags":[],"related":["src-cancer-network"],"cancers":["urothelial"],"sections":[],"technologies":["adc"],"targets":["nectin4"],"drugs":["enfortumab-vedotin","pembrolizumab"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":["pcr","neoadjuvant-adjuvant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03924895","phase":"3","setting":"Cisplatin-ineligible MIBC: perioperative enfortumab vedotin + pembrolizumab with cystectomy vs cystectomy alone","sponsor":"Astellas / Pfizer / Merck","result":"EFS HR 0.40; OS HR 0.50; pCR 57.1% vs 8.6%.","started":"2019-07-24","startedType":"actual","yearReported":2025,"enrolled":344,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival","primary":true,"arms":[{"name":"EV + pembrolizumab, perioperative"},{"name":"Cystectomy alone"}],"hr":0.4,"ci":[0.28,0.56],"source":"https://www.urologytimes.com/view/keynote-905-data-on-ev-pembro-in-mibc-published-in-nejm"},{"endpoint":"Overall survival","arms":[{"name":"EV + pembrolizumab"},{"name":"Cystectomy alone"}],"hr":0.5,"ci":[0.33,0.74]},{"endpoint":"Pathologic complete response","unit":"%","arms":[{"name":"EV + pembrolizumab","value":57.1},{"name":"Cystectomy alone","value":8.6}]}],"replication":"EV-304 (cisplatin-eligible) reported positive EFS, OS, and pCR versus neoadjuvant chemotherapy in December 2025, confirming the perioperative EV + pembrolizumab effect in a second population."},{"id":"ev-304","kind":"trial","name":"EV-304 / KEYNOTE-B15","aka":["EV-304","KEYNOTE-B15"],"tldr":"The trial that could replace chemotherapy before bladder removal in fit patients with an ADC plus immunotherapy.","summary":"EV-304, also KEYNOTE-B15, trial NCT04700124 sponsored by Merck, Astellas and Pfizer and reported from December 2025, is the trial that could replace chemotherapy before bladder removal in fit patients with an antibody-drug conjugate plus immunotherapy. It randomised 808 cisplatin-eligible patients with muscle-invasive bladder cancer to perioperative enfortumab vedotin plus pembrolizumab or neoadjuvant gemcitabine and cisplatin, both with cystectomy, and showed significant improvements in event-free survival, overall survival and pathologic complete response, published in the New England Journal of Medicine with a filing expected in 2026. Whether the pair becomes the default across the whole bladder cancer pathway is the question it and EV-302 together pose.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04700124","url":"https://clinicaltrials.gov/study/NCT04700124"},{"label":"OncLive topline report","url":"https://www.onclive.com/view/perioperative-enfortumab-vedotin-pembrolizumab-meets-efs-os-pcr-end-points-in-cisplatin-eligible-mibc"}],"tags":[],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["enfortumab-vedotin","pembrolizumab"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04700124","phase":"3","setting":"Cisplatin-eligible MIBC: perioperative enfortumab vedotin + pembrolizumab vs neoadjuvant gemcitabine-cisplatin, both with cystectomy","sponsor":"Merck / Astellas / Pfizer","result":"EFS, OS, and pCR significantly improved (topline; details pending).","started":"2021-04-21","startedType":"actual","yearReported":2025,"enrolled":808,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 2 years","primary":true,"unit":"%","arms":[{"name":"Perioperative enfortumab vedotin + pembrolizumab","n":405,"value":79.4},{"name":"Neoadjuvant cisplatin-gemcitabine","n":403,"value":66.2}],"hr":0.53,"ci":[0.41,0.7],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2601486"},{"endpoint":"Overall survival at 2 years","unit":"%","arms":[{"name":"Perioperative enfortumab vedotin + pembrolizumab","value":86.9},{"name":"Neoadjuvant cisplatin-gemcitabine","value":81.3}],"hr":0.65,"ci":[0.48,0.89],"p":"0.006","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2601486"},{"endpoint":"Pathological complete response","unit":"%","arms":[{"name":"Perioperative enfortumab vedotin + pembrolizumab","value":55.8},{"name":"Neoadjuvant cisplatin-gemcitabine","value":32.5}],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2601486"}],"replication":"Mirrors EV-303/KEYNOTE-905 in cisplatin-ineligible MIBC (same regimen, EFS and OS benefit), so the perioperative EV + pembrolizumab effect has now been shown in two randomised populations."},{"id":"nct06806033","kind":"trial","name":"Evaluate Optimization of CRS Profile for Glofit Monotherapy and Glofit+GemOx in R/R Aggressive B-NHL","aka":[],"tldr":"A phase 2 trial of Obinutuzumab, Glofitamab, Gemcitabine and Oxaliplatin in hodgkin lymphoma, run by Hoffmann-La Roche, now recruiting.","summary":"Evaluate Optimization of CRS Profile for Glofit Monotherapy and Glofit+GemOx in R/R Aggressive B-NHL is a phase 2 interventional study registered as NCT06806033 by Hoffmann-La Roche, with 130 participants planned, started 2025-03-05 and due to reach its primary completion in 2027-01-31. Interventions recorded: Obinutuzumab, Glofitamab, Gemcitabine and Oxaliplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06806033","url":"https://clinicaltrials.gov/study/NCT06806033"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","t-cell-engager"],"targets":[],"drugs":["obinutuzumab","glofitamab","gemcitabine","oxaliplatin"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06806033","phase":"2","setting":"A Phase II, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab Monotherapy and Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma","sponsor":"Hoffmann-La Roche","started":"2025-03-05","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05004285","kind":"trial","name":"Evaluate the Clinical Usefulness of [F-18]Florastamin PET/CT Imaging Diagnosis Compared to MRI Diagnosis","aka":[],"tldr":"A phase 3 trial of Florastamin F-18 run by FutureChem, active.","summary":"Evaluate the Clinical Usefulness of [F-18]Florastamin PET/CT Imaging Diagnosis Compared to MRI Diagnosis is a phase 3 interventional study registered as NCT05004285 by FutureChem, with 398 participants planned, started 2021-04-28. Conditions listed: High Risk Prostate Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05004285","url":"https://clinicaltrials.gov/study/NCT05004285"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["florastamin-f18"],"companies":["futurechem"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05004285","phase":"3","setting":"A Multi Center, Non-randomized, Open, Phase 3 Study to Evaluate the Clinical Usefulness of [F-18]Florastamin PET/CT Imaging Diagnosis Compared to MRI Diagnosis in Prostate Cancer Risk Groups","sponsor":"FutureChem","started":"2021-04-28","startedType":"actual","enrolled":398,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04422366","kind":"trial","name":"Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females","aka":[],"tldr":"A phase 3 trial of HPV quadrivalent vaccine in cervical cancer and vulvar cancer, run by Shanghai Bovax Biotechnology Co., Ltd., now recruiting.","summary":"Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females is a phase 3 interventional study registered as NCT04422366 by Shanghai Bovax Biotechnology Co., Ltd., with 8000 participants planned, started 2020-04-28 and due to reach its primary completion in 2027-09-15. Interventions recorded: 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha), GARDASIL®. Conditions listed: Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN1. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04422366","url":"https://clinicaltrials.gov/study/NCT04422366"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","vulvar","vaginal","hpv-associated-vulvar-cancer","vaginal-squamous-cell-carcinoma"],"sections":[],"technologies":["hpv-vaccine","interception-vaccination"],"targets":[],"drugs":["hpv-quadrivalent-vaccine"],"companies":["shanghai-bovax-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04422366","phase":"3","setting":"A Multicenter,Randomized,Blind and Positive-Controlled Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years","sponsor":"Shanghai Bovax Biotechnology Co., Ltd.","started":"2020-04-28","startedType":"actual","enrolled":8000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04390737","kind":"trial","name":"Evaluate the Safety and Clinical Activity of HH2853","aka":[],"tldr":"A phase 1/2 trial of HH2853 Tablets in non-Hodgkin lymphoma, epithelioid sarcoma and peripheral T-cell lymphomas, run by Haihe Biopharma Co., Ltd., now recruiting.","summary":"Evaluate the Safety and Clinical Activity of HH2853 is a phase 1/2 interventional study registered as NCT04390737 by Haihe Biopharma Co., Ltd., with 254 participants planned, started 2020-09-08 and due to reach its primary completion in 2027-12-31. Interventions recorded: HH2853 Tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04390737","url":"https://clinicaltrials.gov/study/NCT04390737"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","epithelioid-sarcoma","peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["haihe-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04390737","phase":"1/2","setting":"A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of HH2853 in Patients With Relapsed/Refractory Non-Hodgkin's Lymphomas or Advanced Solid Tumors","sponsor":"Haihe Biopharma Co., Ltd.","started":"2020-09-08","startedType":"actual","enrolled":254,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05764928","kind":"trial","name":"Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Pemetrexed + Cisplatin Therapy","aka":[],"tldr":"A phase 1/2 trial in lung cancer, run by Rgene Corporation, not yet recruiting.","summary":"Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Pemetrexed + Cisplatin Therapy is a phase 1/2, interventional study registered as NCT05764928 by Rgene Corporation, with a registry enrolment figure of 32 participants, started 2026-12-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: BLEX 404. Conditions listed: Nonsquamous Nonsmall Cell Neoplasm of Lung. Primary outcome: DLT determination; RDL Determination; Overall response rate (PR + CR) after 4 cycles of combination use. Lung eligibility wording from the registry: \"Naïve patients with histologically or pathologically diagnosed with Advanced Inoperable or Metastatic non-small cell lung cancer and intended for first line treatment\". Sites: Taiwan. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05764928","url":"https://clinicaltrials.gov/study/NCT05764928"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05764928","phase":"1/2","setting":"A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of BLEX 404Oral Liquid Combined With Pemetrexed + Cisplatin Therapy in Patients With Advanced Inoperable or Metastatic EGFR Wild-type Non-Small Cell Lung Cancer Patients","sponsor":"Rgene Corporation","started":"2026-12-01","startedType":"estimated","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07095868","kind":"trial","name":"Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Alone and in Combination in Patients With Selected Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by Everest Medicines (Beijing) Co., Ltd., now recruiting.","summary":"Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Alone and in Combination in Patients With Selected Solid Tumors is a phase 1/2 interventional study registered as NCT07095868 by Everest Medicines (Beijing) Co., Ltd., with 94 participants planned, started 2025-11-17 and due to reach its primary completion in 2029-11. Interventions recorded: EVM14 and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07095868","url":"https://clinicaltrials.gov/study/NCT07095868"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","evm14"],"companies":["everest-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07095868","phase":"1/2","setting":"A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Solid Tumors","sponsor":"Everest Medicines (Beijing) Co., Ltd.","started":"2025-11-17","startedType":"actual","enrolled":94,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00542542","kind":"trial","name":"Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery","aka":[],"tldr":"A phase 3 trial of Fentanyl in Breast cancer, run by M.D. Anderson Cancer Center, completed.","summary":"Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery is a phase 3 interventional study registered as NCT00542542 by M.D. Anderson Cancer Center, with 89 participants recorded, started 2007-09 and reaching its primary completion in 2014-03. Interventions recorded: Paravertebral Block, Propofol, Fentanyl, Ropivacaine, Midazolam. Conditions recorded: Breast Cancer.\n\nLinked to the drug Fentanyl because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00542542","url":"https://clinicaltrials.gov/study/NCT00542542"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["fentanyl"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00542542","phase":"3","setting":"Prospective Randomized Clinical Trial to Evaluate the Use of Paravertebral Blocks in Reconstructive Breast Surgery","sponsor":"M.D. Anderson Cancer Center","started":"2007-09","enrolled":89,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04645160","kind":"trial","name":"Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers","aka":[],"tldr":"A phase 1/2 trial of tivozanib in gallbladder cancer and other biliary tract cancers, run by National Cancer Institute (NCI), now recruiting.","summary":"Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers is a phase 1/2 interventional study registered as NCT04645160 by National Cancer Institute (NCI), with a registry enrolment figure of 31 participants, started 2022-03-04 and due to reach its primary completion in 2028-12-31. Interventions recorded: Tivozanib. Conditions listed: Cholangiocarcinoma, Bile Duct Neoplasm, Biliary Tract Malignancy. Gallbladder cancer is named in the registry entry: \"1. Participants with histologically or cytologically confirmed biliary tract cancer (BTC) (cholangiocarcinoma or gallbladder cancer). Archival tumor sample may be used but if archival tissue is not available or is not ad\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04645160","url":"https://clinicaltrials.gov/study/NCT04645160"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["tivozanib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04645160","phase":"1/2","setting":"Phase II Study Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers","sponsor":"National Cancer Institute (NCI)","started":"2022-03-04","startedType":"actual","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05482516","kind":"trial","name":"Evaluating Novel Therapies in ctDNA Positive GI Cancers","aka":["MRD-GI"],"tldr":"A phase 3 trial of atezolizumab and bevacizumab in gallbladder cancer and other biliary tract cancers, run by Georgetown University, now recruiting.","summary":"Evaluating Novel Therapies in ctDNA Positive GI Cancers is a phase 3 interventional study registered as NCT05482516 by Georgetown University, with a registry enrolment figure of 20 participants, started 2023-03-29 and due to reach its primary completion in 2026-12. Interventions recorded: Atezolizumab, Bevacizumab. Conditions listed: Colon Adenocarcinoma, Rectal Adenocarcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma, Hepatocellular Carcinoma, Adenocarcinoma of Biliary Tract, Gallbladder Adenocarcinoma. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05482516","url":"https://clinicaltrials.gov/study/NCT05482516"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["atezolizumab","bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":["ctdna"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05482516","phase":"3","setting":"Evaluating Novel Therapies and ctDNA as a Marker in Curatively-Treated Gastrointestinal Cancers With Microscopic Residual Disease","sponsor":"Georgetown University","started":"2023-03-29","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05037279","kind":"trial","name":"Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)","aka":["EVER"],"tldr":"A phase 3 trial of Bacillus Calmette-Guerin: Strain Russian BCG-I in bladder & urothelial cancer, run by Verity Pharmaceuticals Inc., now recruiting.","summary":"Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC) is a phase 3 interventional study registered as NCT05037279 by Verity Pharmaceuticals Inc., with 540 participants planned, started 2024-04-24 and due to reach its primary completion in 2029-02. Interventions recorded: Bacillus Calmette-Guerin: Strain Russian BCG-I and Bacillus Calmette-Guerin: Strain TICE.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05037279","url":"https://clinicaltrials.gov/study/NCT05037279"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["verity-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05037279","phase":"3","setting":"A Multicenter, Randomized, Double-blind, Controlled Phase III Non-inferiority Study Assessing Efficacy and Safety of VERITY-BCG in Management of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC) in BCG-naïve Patients.","sponsor":"Verity Pharmaceuticals Inc.","started":"2024-04-24","startedType":"actual","enrolled":540,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06596343","kind":"trial","name":"Evaluating the Benefits of Personalized Traditional Chinese Medicine in Postoperative Treatment for Locally Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Sir Run Run Shaw Hospital, not yet recruiting.","summary":"Evaluating the Benefits of Personalized Traditional Chinese Medicine in Postoperative Treatment for Locally Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT06596343 by Sir Run Run Shaw Hospital, with a registry enrolment figure of 80 participants, started 2024-10 and due to reach its primary completion in 2027-09-30. Interventions recorded: Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy. Conditions listed: Locally Advanced Colorectal Cancer; Postoperative Adjuvant Therapy. Primary outcome: The incidence of grade III/IV adverse events. Colorectal eligibility wording from the registry: \"Diagnosed with colorectal cancer at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, and underwent standard radical colorectal cancer surgery\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06596343","url":"https://clinicaltrials.gov/study/NCT06596343"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06596343","phase":"2","setting":"Study on the Value of Traditional Chinese Medicine Precision Treatment Based on Syndrome Differentiation in Postoperative Adjuvant Therapy for Locally Advanced Colorectal Cancer","sponsor":"Sir Run Run Shaw Hospital","started":"2024-10","startedType":"estimated","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07314528","kind":"trial","name":"Evaluating the Impact of GLP-1 Receptor Agonists With Total Neoadjuvant Therapy in Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by St. James's Hospital, Ireland, not yet recruiting.","summary":"Evaluating the Impact of GLP-1 Receptor Agonists With Total Neoadjuvant Therapy in Rectal Cancer is a phase 2, randomised interventional study registered as NCT07314528 by St. James's Hospital, Ireland, with a registry enrolment figure of 42 participants, started 2026-04 and due to reach its primary completion in 2028-09. Interventions recorded: GLP-1 receptor agonist; Total neoadjuvant therapy (TNT). Conditions listed: Rectal Cancer Patients; Obesity &Amp; Overweight; Locally Advanced Rectal Cancer (LARC); Total Neoadjuvant Therapy; GLP-1. Primary outcome: Weight Loss; Metabolic Profile of the Tissue; Inflammatory Mediators. Colorectal eligibility wording from the registry: \"* Histologically confirmed mismatch repair protein proficient adenocarcinoma of the rectum\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07314528","url":"https://clinicaltrials.gov/study/NCT07314528"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07314528","phase":"2","setting":"A Phase II Multi-institutional Randomized Trial Evaluating the Impact of GLP-1 Receptor Agonists in Combination With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer","sponsor":"St. James's Hospital, Ireland","started":"2026-04","startedType":"estimated","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06840821","kind":"trial","name":"Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of MB0151 in Adult Subjects With Advanced Solid Tumors Expressing Somatostatin Receptor","aka":[],"tldr":"A phase 1/2 trial in triple-negative breast cancer, run by Mainline Biosciences (Shanghai) Co., Ltd, now recruiting.","summary":"Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of MB0151 in Adult Subjects With Advanced Solid Tumors Expressing Somatostatin Receptors is a phase 1/2, interventional study registered as NCT06840821 by Mainline Biosciences (Shanghai) Co., Ltd, with a registry enrolment figure of 156 participants, started 2025-05-08 and due to reach its primary completion in 2028-07-04. Interventions recorded: MB0151 for injection. Conditions listed: Advanced Solid Tumors. Triple-negative eligibility wording from the registry: \"The subject must have a solid tumor confirmed by histology or cytology, and belong to one of the following categories: 1) locally advanced or metastatic SCLC, which has received standard treatment in the past and developed progress or intolerance; 2) Low-grade, medium-grade or high-grade locally adv\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06840821","url":"https://clinicaltrials.gov/study/NCT06840821"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06840821","phase":"1/2","setting":"A Phase I/II, Multicenter, Open-label, Single-arm, Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of MB0151 Sequential Therapy in Adult Subjects With Advanced Solid Tumors (Including Gastroenteropancreatic Neuroendocrine Neoplasms, Small Cell Lung Cancer or Triple Negative Breast Cancer)","sponsor":"Mainline Biosciences (Shanghai) Co., Ltd","started":"2025-05-08","startedType":"actual","enrolled":156,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07018869","kind":"trial","name":"Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by SWOG Cancer Research Network, now recruiting.","summary":"Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors is a phase 3, randomised interventional study registered as NCT07018869 by SWOG Cancer Research Network, with a registry enrolment figure of 1057 participants, started 2025-10-15 and due to reach its primary completion in 2029-05-23. Interventions recorded: Intervention website access; Control website access; Interview; Questionnaire Administration. Conditions listed: Colorectal Cancer Stage II; Colorectal Cancer Stage III. Primary outcome: Receipt of colorectal cancer surveillance. Colorectal eligibility wording from the registry: \"* Patient participants must have newly diagnosed surgically resected, stage II or stage III colorectal cancer per the timing described below\". Sites: Guam, Puerto Rico, United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07018869","url":"https://clinicaltrials.gov/study/NCT07018869"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["swog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07018869","phase":"3","setting":"A Pragmatic Randomized Controlled Trial to Evaluate the Effectiveness of an Intervention Called Current Together After Cancer (CTAC) to Promote Guideline-Concordant Colorectal Cancer Surveillance","sponsor":"SWOG Cancer Research Network","started":"2025-10-15","startedType":"actual","enrolled":1057,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01377220","kind":"trial","name":"Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma","aka":[],"tldr":"A phase 2 trial of Choline C-11 in Hepatocellular carcinoma, run by Commissariat A L'energie Atomique, with a status the registry has not verified recently.","summary":"Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma is a phase 2 interventional study registered as NCT01377220 by Commissariat A L'energie Atomique, with 30 participants planned, started 2011-06 and due to reach its primary completion in 2013-06. Interventions recorded: 11C-Choline. Conditions recorded: Hepatocellular Carcinoma.\n\nLinked to the drug Choline C-11 because the registry names it among its interventions and Hepatocellular carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01377220","url":"https://clinicaltrials.gov/study/NCT01377220"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":[],"targets":[],"drugs":["choline-c11"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01377220","phase":"2","setting":"Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma","sponsor":"Commissariat A L'energie Atomique","started":"2011-06","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04235114","kind":"trial","name":"Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR+ Cancers by Positron Emission Tomography (PET)","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by University of Saskatchewan, now recruiting.","summary":"Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR+ Cancers by Positron Emission Tomography (PET) is a phase 1/2, interventional study registered as NCT04235114 by University of Saskatchewan, with a registry enrolment figure of 14 participants, started 2020-02-01 and due to reach its primary completion in 2026-09. Interventions recorded: 50 mg 89Zr-DFO-Nimotuzumab; 1 mg 89Zr-DFO-Nimotuzumab. Conditions listed: Lung Cancer; Colorectal Cancer. Primary outcome: The observation of differences in 89Zr-DFO-nimotuzumab uptake between the tumors and normal tissues using PET/CT.. Colorectal eligibility wording from the registry: \"* Not currently pregnant or nursing: If female subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for \\> 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test is negative\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04235114","url":"https://clinicaltrials.gov/study/NCT04235114"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04235114","phase":"1/2","setting":"Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR Positive Cancers by Positron Emission Tomography (PET)","sponsor":"University of Saskatchewan","started":"2020-02-01","startedType":"actual","enrolled":14,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06262139","kind":"trial","name":"Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients","aka":[],"tldr":"A phase 1/2 trial of MT218 injection in prostate cancer, run by Songqi Gao, now recruiting.","summary":"Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients is a phase 1/2 interventional study registered as NCT06262139 by Songqi Gao, with 12 participants planned, started 2024-07-25 and due to reach its primary completion in 2026-12. Interventions recorded: MT218 injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06262139","url":"https://clinicaltrials.gov/study/NCT06262139"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06262139","phase":"1/2","setting":"An Open-label Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent (MT218) in Prostate Cancer Patients","sponsor":"Songqi Gao","started":"2024-07-25","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04895722","kind":"trial","name":"Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) ","aka":[],"tldr":"A phase 2 trial of Pembrolizumab, Favezelimab in colorectal cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008). is a phase 2 interventional study registered as NCT04895722 by Merck Sharp & Dohme LLC, with 302 participants enrolled, started 2021-06-25 and due to reach its primary completion in 2025-05-21. Interventions recorded: Pembrolizumab, Pembrolizumab/Quavonlimab, Pembrolizumab/Favezelimab, Pembrolizumab/Vibostolimab, MK-4830. Conditions listed: Colorectal Cancer. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04895722","url":"https://clinicaltrials.gov/study/NCT04895722"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","favezelimab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04895722","phase":"2","setting":"A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Co-formulated Quavonlimab (MK-1308)/Pembrolizumab) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer: (MK-1308A-008)","sponsor":"Merck Sharp & Dohme LLC","started":"2021-06-25","startedType":"actual","yearReported":2026,"enrolled":302,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)","primary":true,"unit":"%","arms":[{"name":"Cohort A - Pembrolizumab/Quavonlimab","n":60,"value":45,"note":"95% CI 32.1 to 58.4; Figures from the ClinicalTrials.gov results section (first posted 2026-06-08), not from a publication"},{"name":"Cohort A - Pembrolizumab","n":61,"value":29.5,"note":"95% CI 18.5 to 42.6"},{"name":"Cohort B - Pembrolizumab/Quavonlimab","n":39,"value":46.2,"note":"95% CI 30.1 to 62.8"},{"name":"Cohort B - Pembrolizumab Plus MK-4830","n":20,"value":65,"note":"95% CI 40.8 to 84.6"},{"name":"Cohort B - Pembrolizumab/Favezelimab","n":40,"value":37.5,"note":"95% CI 22.7 to 54.2"},{"name":"Cohort B - Pembrolizumab/Vibostolimab","n":41,"value":48.8,"note":"95% CI 32.9 to 64.9"},{"name":"Cohort B - Pembrolizumab","n":41,"value":41.5,"note":"95% CI 26.3 to 57.9"}],"source":"https://clinicaltrials.gov/study/NCT04895722?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Cohort A - Pembrolizumab/Quavonlimab","n":60,"note":"NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.; Figures from the ClinicalTrials.gov results section (first posted 2026-06-08), not from a publication"},{"name":"Cohort A - Pembrolizumab","n":61,"value":37.1,"note":"95% CI 14.4 to NA"},{"name":"Cohort B - Pembrolizumab/Quavonlimab","n":39,"note":"NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of participants with an event."},{"name":"Cohort B - Pembrolizumab Plus MK-4830","n":20,"note":"NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event."},{"name":"Cohort B - Pembrolizumab/Favezelimab","n":40,"note":"NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event."},{"name":"Cohort B - Pembrolizumab/Vibostolimab","n":41,"note":"NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of participants with an event."},{"name":"Cohort B - Pembrolizumab","n":41,"note":"NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event."}],"source":"https://clinicaltrials.gov/study/NCT04895722?tab=results"}]},{"id":"nct06612281","kind":"trial","name":"Evaluation of Gixam's Performance in a FIT Negative Population","aka":[],"tldr":"A phase 2 trial of colorectal cancer (CRC) screening in colorectal cancer, run by Jubaan Ltd., now recruiting.","summary":"Evaluation of Gixam's Performance in a FIT Negative Population is a phase 2 interventional study registered as NCT06612281 by Jubaan Ltd., with 400 participants planned, started 2024-11-01 and due to reach its primary completion in 2025-03-30. Interventions recorded: colorectal cancer (CRC) screening and Colonoscopy after bowel cleansing.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06612281","url":"https://clinicaltrials.gov/study/NCT06612281"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06612281","phase":"2","setting":"Evaluation of Gixam's Performance in a FIT Negative Population","sponsor":"Jubaan Ltd.","started":"2024-11-01","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07617493","kind":"trial","name":"Evaluation of ICP-B208 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ICP-B208 in advanced solid tumours, run by Beijing InnoCare Pharma Tech Co., Ltd., now recruiting.","summary":"Evaluation of ICP-B208 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07617493 by Beijing InnoCare Pharma Tech Co., Ltd., with 539 participants planned, started 2026-07-03 and due to reach its primary completion in 2030-12. Interventions recorded: ICP-B208.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07617493","url":"https://clinicaltrials.gov/study/NCT07617493"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["innocare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07617493","phase":"1/2","setting":"An Open, Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Efficacy of ICP-B208 in Participants of Advanced Solid Tumor Trials","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","started":"2026-07-03","startedType":"actual","enrolled":539,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06643793","kind":"trial","name":"Evaluation of Irinotecan Liposome (II) Combined With 5-FU, LV, and Bevacizumab for mCRC","aka":[],"tldr":"A phase 2 trial of fluorouracil (5-FU), leucovorin (folinic acid) and bevacizumab (glioblastoma use) in colorectal cancer, run by Affiliated Hospital of Nantong University, now recruiting.","summary":"Evaluation of Irinotecan Liposome (II) Combined With 5-FU, LV, and Bevacizumab for mCRC is a phase 2, interventional study registered as NCT06643793 by Affiliated Hospital of Nantong University, with a registry enrolment figure of 30 participants, started 2024-11-04 and due to reach its primary completion in 2026-10-31. Interventions recorded: Irinotecan liposome (ll) + 5-FU/LV + bevacizumab. Conditions listed: Colorectal Neoplasms Malignant. Primary outcome: Objective response rate (ORR). Colorectal eligibility wording from the registry: \"Diagnosis of colorectal cancer by histopathology and/or cytology, clinical Records showing inoperable advanced metastatic colon or rectal cancer (ie, stage IV according to the UICC AJCC TNM staging system \\[8th edition 2017\\]) ;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06643793","url":"https://clinicaltrials.gov/study/NCT06643793"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","leucovorin","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06643793","phase":"2","setting":"Evaluation of Irinotecan Liposome (II) Combined With 5-fluorouracil, Leucovorin, and Bevacizumab for Second-line/Third-line Treatment of Metastatic Colorectal Cancer (mCRC): a Prospective and Exploratory Clinical Study","sponsor":"Affiliated Hospital of Nantong University","started":"2024-11-04","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06775483","kind":"trial","name":"Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance： a Phase II Clinical Study","aka":[],"tldr":"A phase 2 trial of JSKN016 and docetaxel in lung cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd, not yet recruiting.","summary":"Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance： a Phase II Clinical Study is a phase 2, randomised interventional study registered as NCT06775483 by Jiangsu Alphamab Biopharmaceuticals Co., Ltd, with a registry enrolment figure of 220 participants, started 2025-01-17 and due to reach its primary completion in 2027-06-30. Interventions recorded: JSKN016; Docetaxel. Conditions listed: Advanced Non-small Cell Lung Cancer. Primary outcome: ORR assessed by the investigator per RECIST v1.1; Safety reflected by AE. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not suitable for radical surgery and/or radical radiotherapy, and meets one of the following conditions: EGFR sensitive mutations, and failed treatment with EGFR-TKI; Driver gene negat\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06775483","url":"https://clinicaltrials.gov/study/NCT06775483"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["jskn016","docetaxel"],"companies":["alphamab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06775483","phase":"2","setting":"Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance： a Phase II Clinical Study","sponsor":"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","started":"2025-01-17","startedType":"estimated","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05696626","kind":"trial","name":"Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation","aka":["ELAINEIII"],"tldr":"A phase 3 trial of Abemaciclib and Fulvestrant in advanced solid tumours, run by LeonaBio, now recruiting.","summary":"Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation is a phase 3 interventional study registered as NCT05696626 by LeonaBio, with 600 participants planned, started 2023-10-31 and due to reach its primary completion in 2027-04. Interventions recorded: Lasofoxifene in combination with abemaciclib and Fulvestrant in combination with abemaciclib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05696626","url":"https://clinicaltrials.gov/study/NCT05696626"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy"],"targets":[],"drugs":["abemaciclib","fulvestrant"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05696626","phase":"3","setting":"An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation","sponsor":"LeonaBio","started":"2023-10-31","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06270017","kind":"trial","name":"Evaluation of Metastatic Disease and Oncological Treatment in Patients With Colon Cancer Using Zebra Fish Avatars","aka":["ZEBRA-COLON"],"tldr":"A phase 1/2 trial in colorectal cancer, run by University Hospital, Linkoeping, now recruiting.","summary":"Evaluation of Metastatic Disease and Oncological Treatment in Patients With Colon Cancer Using Zebra Fish Avatars is a phase 1/2, interventional study registered as NCT06270017 by University Hospital, Linkoeping, with a registry enrolment figure of 300 participants, started 2022-01-10 and due to reach its primary completion in 2025-12-31. Interventions recorded: Chemotherapy drug. Conditions listed: Colon Cancer. Primary outcome: Tumour growth. Colorectal eligibility wording from the registry: \"* Colon cancer planned for radical colon resection signed informed consent\". Sites: Sweden. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06270017","url":"https://clinicaltrials.gov/study/NCT06270017"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06270017","phase":"1/2","setting":"Evaluation of Metastatic Disease and Oncological Treatment in Patients With Colon Cancer","sponsor":"University Hospital, Linkoeping","started":"2022-01-10","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07669519","kind":"trial","name":"Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy","aka":[],"tldr":"A phase 3 trial of Nuvastatic™ in colorectal cancer, run by Natureceuticals Sdn Bhd, now recruiting.","summary":"Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy is a phase 3 interventional study registered as NCT07669519 by Natureceuticals Sdn Bhd, with 180 participants planned, started 2025-08-18 and due to reach its primary completion in 2027-03-31. Interventions recorded: Nuvastatic™ and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07669519","url":"https://clinicaltrials.gov/study/NCT07669519"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["natureceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07669519","phase":"3","setting":"Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy","sponsor":"Natureceuticals Sdn Bhd","started":"2025-08-18","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04485286","kind":"trial","name":"Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Massachusetts General Hospital, now recruiting.","summary":"Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury is a phase 2, interventional study registered as NCT04485286 by Massachusetts General Hospital, with a registry enrolment figure of 72 participants, started 2020-07-19 and due to reach its primary completion in 2027-05. Interventions recorded: [68Ga]CBP8. Conditions listed: Lung Cancer; Radiation Fibrosis; Radiation Induced Lung Injury; Pancreas Cancer. Primary outcome: Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury.. Pancreatic eligibility wording from the registry: \"Inclusion Criteria for pancreatic cancer subjects:\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04485286","url":"https://clinicaltrials.gov/study/NCT04485286"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04485286","phase":"2","setting":"Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury","sponsor":"Massachusetts General Hospital","started":"2020-07-19","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06872541","kind":"trial","name":"Evaluation of Platelet Aggregability in Patients with Non-small Cell Lung Carcinomas","aka":[],"tldr":"A phase 2/3 trial in lung cancer, run by University of Sao Paulo, active but no longer recruiting.","summary":"Evaluation of Platelet Aggregability in Patients with Non-small Cell Lung Carcinomas is a phase 2/3, interventional study registered as NCT06872541 by University of Sao Paulo, with a registry enrolment figure of 100 participants, started 2025-01-20 and due to reach its primary completion in 2026-10-20. Interventions recorded: Clopidogrel. Conditions listed: Assessment of Platelet Aggregability in Patients Patients with Non-small Cell Lung Carcinoma. Primary outcome: Platelet Aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories). Lung eligibility wording from the registry: \"* Confirmed diagnosis of non-small cell lung carcinoma in the case group; absence of history of any neoplasia for control group\". Sites: Brazil. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06872541","url":"https://clinicaltrials.gov/study/NCT06872541"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06872541","phase":"2/3","setting":"Evaluation of Platelet Aggregability in Patients with Non-small Cell Lung Carcinomas","sponsor":"University of Sao Paulo","started":"2025-01-20","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01767714","kind":"trial","name":"Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5×10^6CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation","aka":[],"tldr":"A phase 3 trial of Filgrastim and Plerixafor in Non-Hodgkin lymphoma, run by Sanofi, completed.","summary":"Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5×10^6CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation is a phase 3 interventional study registered as NCT01767714 by Sanofi, with 100 participants recorded, started 2013-04 and reaching its primary completion in 2014-11. Interventions recorded: Granulocyte-colony stimulating factor (G-CSF), Plerixafor, Placebo. Conditions recorded: Non-Hodgkin's Lymphoma.\n\nLinked to the drug Plerixafor because the registry names it among its interventions and Non-Hodgkin lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01767714","url":"https://clinicaltrials.gov/study/NCT01767714"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["filgrastim","plerixafor"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01767714","phase":"3","setting":"A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of Plerixafor (0.24 mg/kg) Plus G CSF (10 µg/kg) Versus G CSF (10 µg/kg) Plus Placebo to Mobilize and Collect ≥5 × 106 CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation","sponsor":"Sanofi","started":"2013-04","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06824064","kind":"trial","name":"Evaluation of RBS2418 in Patients With Advanced, Metastatic, and Progressive Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of RBS2418 in colorectal cancer, run by Riboscience, LLC., now recruiting.","summary":"Evaluation of RBS2418 in Patients With Advanced, Metastatic, and Progressive Colorectal Cancer is a phase 2 interventional study registered as NCT06824064 by Riboscience, LLC., with 150 participants planned, started 2025-01-17 and due to reach its primary completion in 2027-12. Interventions recorded: RBS2418 and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06824064","url":"https://clinicaltrials.gov/study/NCT06824064"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06824064","phase":"2","setting":"A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of RBS2418 Plus Best Supportive Care (BSC) in Subjects With Advanced, Metastatic, and Progressive Colorectal Cancer","sponsor":"Riboscience, LLC.","started":"2025-01-17","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03579836","kind":"trial","name":"Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of Gemcitabine in pancreatic ductal adenocarcinoma, run by BeyondBio Inc., now recruiting.","summary":"Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer is a phase 1/2 interventional study registered as NCT03579836 by BeyondBio Inc., with 75 participants planned, started 2018-05-14 and due to reach its primary completion in 2026-11-30. Interventions recorded: BEY1107 and Gemcitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03579836","url":"https://clinicaltrials.gov/study/NCT03579836"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03579836","phase":"1/2","setting":"A Single Center, Open-label, Non-comparative, Phase I/II Clinical Trial to Assess the MTD, Safety and Efficacy of BEY1107 in Monotherapy and in Combination with Gemcitabine in Patient with Locally Advanced or Metastatic Pancreatic Cancer","sponsor":"BeyondBio Inc.","started":"2018-05-14","startedType":"actual","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00911326","kind":"trial","name":"Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma","aka":[],"tldr":"A phase 3 trial of Technetium-99m tilmanocept in Head and neck squamous cell carcinoma, run by Navidea Biopharmaceuticals, recorded as terminated on the registry.","summary":"Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma is a phase 3 interventional study registered as NCT00911326 by Navidea Biopharmaceuticals, with 101 participants recorded, started 2009-05 and due to reach its primary completion in 2013-08. Interventions recorded: Lymphoseek. Conditions recorded: Head and Neck Squamous Cell Carcinoma (HNSCC).\n\nLinked to the drug Technetium-99m tilmanocept because the registry names it among its interventions and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00911326","url":"https://clinicaltrials.gov/study/NCT00911326"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","oral-cavity-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tilmanocept-tc99m"],"companies":["navidea"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00911326","phase":"3","setting":"A Ph 3, Prospective, Open-Label, Multicenter Study of Lymphoseek®-Identified Sentinel Lymph Nodes (SLNs) Relative to the Path Status of Non SLN in an Elective Neck Dissection in Cutaneous Head and Neck and Intraoral Squamous Cell Carcinoma","sponsor":"Navidea Biopharmaceuticals","started":"2009-05","yearReported":2014,"enrolled":101,"enrolledBasis":"registry","outcomes":[{"endpoint":"False Negative Rate (FNR)","primary":true,"unit":"%","arms":[{"name":"Intent-to-treat (ITT)","n":83,"value":2.56,"note":"95% CI 0.06 to 13.49; Figures from the ClinicalTrials.gov results section (first posted 2014-08-08), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00911326?tab=results"}]},{"id":"nct06944548","kind":"trial","name":"Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer","aka":["APACOL"],"tldr":"A phase 2 trial in colorectal cancer, run by Centre Georges Francois Leclerc, not yet recruiting.","summary":"Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer is a phase 2, randomised interventional study registered as NCT06944548 by Centre Georges Francois Leclerc, with a registry enrolment figure of 54 participants, started 2025-06-01 and due to reach its primary completion in 2030-06-01. Interventions recorded: Lipidomic analyses; Adapted physical activity program. Conditions listed: Metastatic Colorectal Cancer (CRC); Volunteer Subjects. Primary outcome: To determine the impact of adapted physical activity on the concentration of complex lipids in a population of patients with metastatic colorectal cancer treated with chemotherapy.. Colorectal eligibility wording from the registry: \"* Patient with histologically proven metastatic colorectal cancer\". Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06944548","url":"https://clinicaltrials.gov/study/NCT06944548"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06944548","phase":"2","setting":"Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Metastatic COLorectal Cancer","sponsor":"Centre Georges Francois Leclerc","started":"2025-06-01","startedType":"estimated","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07056777","kind":"trial","name":"Evaluation of the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Cancer","aka":[],"tldr":"A phase 1/2 trial of Oxaliplatin, Capecitabine and Leucovorin (folinic acid) in advanced solid tumours, run by Zhejiang Doer Biologics Co., Ltd., now recruiting.","summary":"Evaluation of the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Cancer is a phase 1/2 interventional study registered as NCT07056777 by Zhejiang Doer Biologics Co., Ltd., with 186 participants planned, started 2025-03-25 and due to reach its primary completion in 2027-04-30. Interventions recorded: DR30206, Oxaliplatin, Capecitabine, Calcium Folinate, 5-FU and Irinotecan (CPT-11).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07056777","url":"https://clinicaltrials.gov/study/NCT07056777"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["oxaliplatin","capecitabine","leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07056777","phase":"1/2","setting":"A Phase Ib/IIa Clinical Trial Evaluating the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Tumors","sponsor":"Zhejiang Doer Biologics Co., Ltd.","started":"2025-03-25","startedType":"actual","enrolled":186,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07499674","kind":"trial","name":"Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung","aka":["VISUALIZE-2"],"tldr":"A phase 3 trial of Abenacianine in advanced solid tumours, run by Vergent Bioscience, Inc., now recruiting.","summary":"Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung is a phase 3 interventional study registered as NCT07499674 by Vergent Bioscience, Inc., with 132 participants planned, started 2026-03-31 and due to reach its primary completion in 2026-12. Interventions recorded: Abenacianine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07499674","url":"https://clinicaltrials.gov/study/NCT07499674"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["vergent-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07499674","phase":"3","setting":"A Phase 3, Multi-center, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Abenacianine (VGT-309), a Tumor-Targeted, Activatable Fluorescent Imaging Agent, to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung - VISUALIZE 2","sponsor":"Vergent Bioscience, Inc.","started":"2026-03-31","startedType":"actual","enrolled":132,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07787429","kind":"trial","name":"Evaluation of the Safety and Efficacy of Mifamurtide Versus Standard Treatment With Sorafenib in Patients With High-risk Osteosarcoma","aka":["DRAGONFLY"],"tldr":"A phase 2 trial of Mifamurtide and Sorafenib in Osteosarcoma, run by Anna Raciborska, now recruiting.","summary":"Evaluation of the Safety and Efficacy of Mifamurtide Versus Standard Treatment With Sorafenib in Patients With High-risk Osteosarcoma is a phase 2 interventional study registered as NCT07787429 by Anna Raciborska, with 40 participants planned, started 2026-04-01 and due to reach its primary completion in 2033-07-31. Interventions recorded: Mifamurtide, Sorafenib. Conditions recorded: Osteosarcoma.\n\nLinked to the drug Mifamurtide because the registry names it among its interventions and Osteosarcoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07787429","url":"https://clinicaltrials.gov/study/NCT07787429"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["osteosarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["mifamurtide","sorafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07787429","phase":"2","setting":"Evaluation of the Safety and Efficacy of Mifamurtide Versus Standard Treatment With Sorafenib in Patients With High-risk Osteosarcoma (DRAGONFLY)","sponsor":"Anna Raciborska","started":"2026-04-01","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06607458","kind":"trial","name":"Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatme","aka":[],"tldr":"A phase 2 trial of Melphalan, Bevacizumab in colorectal cancer, run by Delcath Systems Inc., now recruiting.","summary":"Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease is a phase 2 interventional study registered as NCT06607458 by Delcath Systems Inc., with 90 participants planned, started 2025-08-05 and due to reach its primary completion in 2026-12. Interventions recorded: Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab, Trifluridine-tipiracil plus Bevacizumab Alone. Conditions listed: Refractory Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06607458","url":"https://clinicaltrials.gov/study/NCT06607458"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["melphalan","bevacizumab"],"companies":["delcath"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06607458","phase":"2","setting":"An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment With Melphalan/HDS Followed by Consolidation Treatment With Trifluridine-Tipiracil Plus Bevacizumab Versus Trifluridine-Tipiracil Plus Bevacizumab Alone in Patients With Refractory Metastatic Colorectal Cancer With Liver Dominant Disease","sponsor":"Delcath Systems Inc.","started":"2025-08-05","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07136181","kind":"trial","name":"Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma","aka":[],"tldr":"A phase 1/2 trial of NBM-BMX Capsule are proprietary products developed by Novelwise Pharmaceutical Corporation (Novelwise) for treatment of patients suffering from cancers. in uveal melanoma, run by Novelwise Pharmaceutical Corporation, now recruiting.","summary":"Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma is a phase 1/2 interventional study registered as NCT07136181 by Novelwise Pharmaceutical Corporation, with 36 participants planned, started 2025-11-20 and due to reach its primary completion in 2028-03-28. Interventions recorded: NBM-BMX Capsule are proprietary products developed by Novelwise Pharmaceutical Corporation (Novelwise) for treatment of patients suffering from cancers..","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07136181","url":"https://clinicaltrials.gov/study/NCT07136181"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["uveal-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07136181","phase":"1/2","setting":"A Multicenter Phase Ib/II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma","sponsor":"Novelwise Pharmaceutical Corporation","started":"2025-11-20","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07097064","kind":"trial","name":"Evaluation of the Stereotactic MR-guided Adaptive Radiotherapy for Locally Advanced Pancreatic Cancers","aka":["RAIPANC"],"tldr":"A phase 2 trial in pancreatic cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle, not yet recruiting.","summary":"Evaluation of the Stereotactic MR-guided Adaptive Radiotherapy for Locally Advanced Pancreatic Cancers is a phase 2, randomised interventional study registered as NCT07097064 by Institut du Cancer de Montpellier - Val d'Aurelle, with a registry enrolment figure of 160 participants, started 2025-09 and due to reach its primary completion in 2028-09. Interventions recorded: standard radiotherapy with chemotherapy; MRI-guided adaptive stereotactic radiotherapy (SMART). Conditions listed: Locally Advanced Pancreatic Adenocarcinoma. Primary outcome: Improvement of local control at 1 year by 20% in the experimental cohort compared with the standard cohort.. Pancreatic eligibility wording from the registry: \"* Histologically proven pancreatic adenocarcinoma ;\". Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07097064","url":"https://clinicaltrials.gov/study/NCT07097064"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07097064","phase":"2","setting":"Evaluation of the Stereotactic MR-guided Adaptive Radiotherapy for Locally Advanced Pancreatic Cancers","sponsor":"Institut du Cancer de Montpellier - Val d'Aurelle","started":"2025-09","startedType":"estimated","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07407803","kind":"trial","name":"Evaluation of TQ-B3234 Capsules in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas","aka":[],"tldr":"A phase 3 trial testing TQ-B3234 in rare cancers of childhood, now recruiting.","summary":"Evaluation of TQ-B3234 Capsules in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas is a phase 3 interventional study registered as NCT07407803, led by Chia Tai Tianqing Pharmaceutical, and recruiting on the registry. Official title: Randomised, Double-Blind, Parallel-Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of TQ-B3234 Capsules Versus Placebo in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas. Planned enrolment is 177 participants (estimated). The study started in 2026-03-31 and primary completion is expected in 2027-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07407803","url":"https://clinicaltrials.gov/study/NCT07407803"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rare-childhood-cancers"],"sections":[],"technologies":[],"targets":[],"drugs":["tq-b3234"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07407803","phase":"3","setting":"Randomized, Double-Blind, Parallel-Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of TQ-B3234 Capsules Versus Placebo in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas","sponsor":"Chia Tai Tianqing Pharmaceutical","started":"2026-03-31","startedType":"actual","enrolled":177,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06702618","kind":"trial","name":"Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer","aka":[],"tldr":"A phase 2 trial of Fulvestrant and TQB3616 in advanced solid tumours, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., active and no longer recruiting.","summary":"Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer is a phase 2 interventional study registered as NCT06702618 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with 33 participants enrolled, started 2025-02-20 and due to reach its primary completion in 2026-06. Interventions recorded: TQB3616 capsule+Fulvestrant Injection.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06702618","url":"https://clinicaltrials.gov/study/NCT06702618"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["fulvestrant","tqb3616"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06702618","phase":"2","setting":"Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined With Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6（CDK4/6)Inhibitor-Resistant, Hormone Receptor(HR)-Positive, Human Epidermal Growth Factor Receptor 2(HER2)-Negative Recurrent/Metastatic Breast Cancer","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","started":"2025-02-20","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06824168","kind":"trial","name":"Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission","aka":[],"tldr":"A phase 2 trial of Quizartinib in acute myeloid leukaemia, run by Daiichi Sankyo, now recruiting.","summary":"Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission is a phase 2 interventional study registered as NCT06824168 by Daiichi Sankyo, with 130 participants planned, started 2025-07-18 and due to reach its primary completion in 2028-06-06. Interventions recorded: Quizartinib High Dose and Quizartinib Low Dose.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06824168","url":"https://clinicaltrials.gov/study/NCT06824168"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["quizartinib"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06824168","phase":"2","setting":"A Phase 2, Multicenter, Randomized, Open-label Trial to Evaluate Safety and Efficacy of Two Dose Levels of Quizartinib as Maintenance for Adult Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia in Complete Remission","sponsor":"Daiichi Sankyo","started":"2025-07-18","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07670312","kind":"trial","name":"Evaluation of XYA02 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by XYone Therapeutics, Inc, not yet recruiting.","summary":"Evaluation of XYA02 in Patients With Advanced Solid Tumors is a phase 1/2, interventional study registered as NCT07670312 by XYone Therapeutics, Inc, with a registry enrolment figure of 190 participants, started 2026-07-15 and due to reach its primary completion in 2029-07-15. Interventions recorded: XYA02. Conditions listed: MUC1-expressing Advanced, Relapsed and/or Refractory Solid Tumors; Non-Small Cell Lung Cancer; Ovarian Cancer; GEJ Adenocarcinoma; Colorectal Cancer; Pancreatic Adenocarcinoma. Primary outcome: Frequency of Treatment Emergent Adverse Events of XYA02; Duration of Treatment Emergent Adverse Events of XYA02; Severity of Treatment Emergent Adverse Events of XYA02. Pancreatic eligibility wording from the registry: \"Cohort 2E: Pancreatic cancer\". Sites: Australia. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07670312","url":"https://clinicaltrials.gov/study/NCT07670312"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07670312","phase":"1/2","setting":"A Phase 1b/2, Multicenter, Non-randomized, Open-label, Multiple Dose First- In-Human Study of XYA02 in Patients With Advanced Solid Tumors","sponsor":"XYone Therapeutics, Inc","started":"2026-07-15","startedType":"estimated","enrolled":190,"enrolledBasis":"registry","outcomes":[]},{"id":"evera","kind":"trial","name":"evERA","aka":[],"tldr":"In evERA, pairing an oral SERD with everolimus after CDK4/6 failure delayed progression by more than three months, and by four and a half months in ESR1-mutant tumours.","summary":"evERA, trial NCT05306340 sponsored by Roche and Genentech and reported at ESMO 2025, showed that pairing the oral SERD giredestrant with everolimus after CDK4/6 inhibitor failure in ER-positive, HER2-negative advanced breast cancer delayed progression by more than three months, and by about four and a half months in ESR1-mutant tumours. It randomised 320 women to giredestrant or standard endocrine therapy, each with everolimus, and met its primary progression-free survival endpoints in both the intention-to-treat and ESR1-mutant populations, after which the FDA accepted a new drug application for the ESR1-mutant indication in February 2026. OnCo links it to the oestrogen receptor, giredestrant, everolimus and exemestane, and the result is consistent with BOLERO-2 for the everolimus backbone. Whether the combination beats an oral SERD alone is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05306340","url":"https://clinicaltrials.gov/study/NCT05306340"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["endocrine-therapy"],"targets":["estrogen-receptor"],"drugs":["giredestrant","everolimus"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05306340","phase":"3","setting":"ER+/HER2- advanced breast cancer after CDK4/6 inhibitor: giredestrant + everolimus vs standard endocrine therapy + everolimus","sponsor":"Roche / Genentech","result":"PFS HR 0.56 (ITT); HR 0.38 (ESR1-mutant).","started":"2022-08-03","startedType":"actual","yearReported":2025,"enrolled":320,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 373 participants (actual); 320 is the randomised population presented at ESMO 2025 and quoted in the summary. No journal paper is indexed on Europe PMC yet, so the figure has not been checked against a primary publication.","outcomes":[{"endpoint":"Progression-free survival (ITT)","primary":true,"unit":"months","arms":[{"name":"Giredestrant + everolimus","value":8.77},{"name":"Standard ET + everolimus","value":5.49}],"hr":0.56,"ci":[0.44,0.71],"p":"<0.0001","source":"https://www.roche.com/media/releases/med-cor-2025-10-18"},{"endpoint":"Progression-free survival (ESR1-mutant)","primary":true,"unit":"months","arms":[{"name":"Giredestrant + everolimus","value":9.99},{"name":"Standard ET + everolimus","value":5.45}],"hr":0.38,"ci":[0.27,0.54],"p":"<0.0001"}],"replication":"Consistent with BOLERO-2 (everolimus + exemestane) as the backbone and with other oral SERDs in ESR1-mutant disease."},{"id":"nct06301386","kind":"trial","name":"Everolimus Combined With PD-1 in Advanced Colorectal Cancer Patients","aka":[],"tldr":"A phase 2 trial of everolimus in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"Everolimus Combined With PD-1 in Advanced Colorectal Cancer Patients is a phase 2, interventional study registered as NCT06301386 by Fudan University, with a registry enrolment figure of 25 participants, started 2024-04-01 and due to reach its primary completion in 2026-05-01. Interventions recorded: Everolimus; PD-1. Conditions listed: Colon Cancer. Primary outcome: objective response rate (ORR). Colorectal eligibility wording from the registry: \"Patients with histologically or cytologically confirmed locally advanced and advanced colorectal cancer that cannot be R0 resected;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06301386","url":"https://clinicaltrials.gov/study/NCT06301386"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["everolimus"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06301386","phase":"2","setting":"The Combination of Everolimus and PD-1 in the Treatment of Locally Advanced and Advanced Colorectal Cancer That Cannot be R0 Resected","sponsor":"Fudan University","started":"2024-04-01","startedType":"estimated","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07435584","kind":"trial","name":"Everolimus in CDK12-Deficient Metastatic Colorectal Cancer (EVER-RECODE)","aka":["EVER-RECODE"],"tldr":"A phase 1/2 trial in colorectal cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, not yet recruiting.","summary":"Everolimus in CDK12-Deficient Metastatic Colorectal Cancer (EVER-RECODE) is a phase 1/2, interventional study registered as NCT07435584 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 38 participants, started 2026-03-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: Everolimus (Afinitor) tablets. Conditions listed: Colorectal Cancer. Primary outcome: Incidence of Dose-Limiting Toxicities (DLTs); Objective Response Rate (ORR). Colorectal eligibility wording from the registry: \"Histologically confirmed metastatic colorectal cancer with documented disease progression after prior standard systemic antitumor therapies, including but not limited to oxaliplatin, fluoropyrimidine, and irinotecan\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07435584","url":"https://clinicaltrials.gov/study/NCT07435584"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07435584","phase":"1/2","setting":"Everolimus in Refractory Metastatic Colorectal Cancer With CDK12 Deficiency: A Prospective Multicenter Phase Ib/II Study (EVER-RECODE)","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2026-03-01","startedType":"estimated","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05455619","kind":"trial","name":"Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer","aka":["Amelia-1"],"tldr":"A phase 1/2 trial of Evexomostat in advanced solid tumours, run by SynDevRx, Inc., now recruiting.","summary":"Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer is a phase 1/2 interventional study registered as NCT05455619 by SynDevRx, Inc., with 52 participants planned, started 2022-08-26 and due to reach its primary completion in 2026-12. Interventions recorded: Evexomostat.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05455619","url":"https://clinicaltrials.gov/study/NCT05455619"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["evexomostat"],"companies":["syndevrx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05455619","phase":"1/2","setting":"Study to Assess the Safety and Efficacy of Evexomostat (SDX-7320) in Combination With A PI3K or Akt Inhibitor Plus Fulvestrant in Patients With HR+, HER2-, Metastatic Breast Cancer With PI3K Pathway Alteration(s)","sponsor":"SynDevRx, Inc.","started":"2022-08-26","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07340541","kind":"trial","name":"Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies","aka":["EVOLVE-BDT"],"tldr":"A phase 2 trial of abemaciclib, everolimus and capecitabine in triple-negative breast cancer, run by UNC Lineberger Comprehensive Cancer Center, now recruiting.","summary":"Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies is a phase 2, interventional study registered as NCT07340541 by UNC Lineberger Comprehensive Cancer Center, with a registry enrolment figure of 700 participants, started 2026-02-16 and due to reach its primary completion in 2031-06-02. Interventions recorded: SERD* + abemaciclib; SERD* + everolimus; SERD* + everolimus or capecitabine; SOC; Antiandrogen. Conditions listed: Breast Cancer; Metastatic Breast Cancer; Triple Negative Breast Cancer; Estrogen-receptor-positive Breast Cancer; Hormone Receptor Negative Breast Carcinoma. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07340541","url":"https://clinicaltrials.gov/study/NCT07340541"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["abemaciclib","everolimus","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07340541","phase":"2","setting":"TBCRC Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT)","sponsor":"UNC Lineberger Comprehensive Cancer Center","started":"2026-02-16","startedType":"actual","enrolled":700,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04675333","kind":"trial","name":"Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)","aka":["ASPEN-04"],"tldr":"A phase 2 trial of Evorpacept, Pembrolizumab, Cisplatin in head and neck squamous cell carcinoma, run by ALX Oncology Inc., active and no longer recruiting.","summary":"Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04) is a phase 2 interventional study registered as NCT04675333 by ALX Oncology Inc., with 172 participants enrolled, started 2021-05-10 and due to reach its primary completion in 2025-03-03. Interventions recorded: evorpacept, pembrolizumab, Cisplatin/Carboplatin; 5FU. Conditions listed: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04675333","url":"https://clinicaltrials.gov/study/NCT04675333"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":["cd47-blockade","checkpoint-inhibitor"],"targets":[],"drugs":["evorpacept","pembrolizumab","cisplatin","carboplatin","fluorouracil"],"companies":["alx-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04675333","phase":"2","setting":"A Phase 2 Study of ALX148 in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)","sponsor":"ALX Oncology Inc.","started":"2021-05-10","startedType":"actual","enrolled":172,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04675294","kind":"trial","name":"Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)","aka":["ASPEN-03"],"tldr":"A phase 2 trial of Evorpacept, Pembrolizumab in head and neck squamous cell carcinoma, run by ALX Oncology Inc., active and no longer recruiting.","summary":"Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03) is a phase 2 interventional study registered as NCT04675294 by ALX Oncology Inc., with 189 participants enrolled, started 2021-04-02 and due to reach its primary completion in 2025-03-03. Interventions recorded: evorpacept, pembrolizumab. Conditions listed: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04675294","url":"https://clinicaltrials.gov/study/NCT04675294"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":["cd47-blockade","checkpoint-inhibitor"],"targets":[],"drugs":["evorpacept","pembrolizumab"],"companies":["alx-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04675294","phase":"2","setting":"A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)","sponsor":"ALX Oncology Inc.","started":"2021-04-02","startedType":"actual","enrolled":189,"enrolledBasis":"registry","outcomes":[]},{"id":"rejuv-trial-ex-cipn","kind":"trial","name":"EX-CIPN: virtual exercise-based rehabilitation for persistent chemotherapy nerve damage","aka":["EX-CIPN","NCT07481149"],"tldr":"Nothing prevents chemotherapy nerve damage and the only drug with guideline support for the established painful form has a benefit the guideline itself calls limited. This pragmatic trial tests ten weeks of individualised remote exercise against usual care.","summary":"The nerve-damage record on this front states the position the trial is built against: ASCO recommends no agent for the prevention of chemotherapy-induced peripheral neuropathy, duloxetine is the only agent with appropriate evidence for established painful neuropathy and the guideline says the amount of benefit is limited, and a long list of other candidates has failed or has no reliable evidence. Scrambler therapy's only blinded comparison found the dummy device did as well.\n\nEX-CIPN is a pragmatic, parallel-group, two-arm randomised controlled trial of a ten-week programme: an individualised progressive exercise prescription including cardiovascular and strength training plus balance and desensitisation work specific to neuropathy symptoms, remote monitoring with an activity tracker, and health coaching calls in weeks 2, 3, 4, 6 and 8. The control arm receives usual oncology care and is offered the programme after completing study assessments. Masking covers the care provider and the outcomes assessor.\n\nThe primary endpoint is the EORTC CIPN-20 questionnaire, scored 20 to 80 with higher scores worse, measured at baseline, at the end of the ten weeks, and at three and six months afterwards. That a phase 3 trial in this condition is using a symptom questionnaire rather than nerve conduction is itself informative about where the field's endpoints stand.\n\nRegistry dates, read on 2 October 2026: start 30 March 2026 (actual), primary completion and completion July 2029 (estimated). Enrolment of 240 is the registry's estimate.","status":"recruiting","asOf":"2026-10-02","links":[{"label":"ClinicalTrials.gov NCT07481149","url":"https://clinicaltrials.gov/study/NCT07481149"},{"label":"Loprinzi et al., Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: ASCO guideline update (JCO 2020)","url":"https://doi.org/10.1200/JCO.20.01399"}],"tags":["rejuvenation","survivorship","open-problem","neuropathy","rehabilitation","exercise"],"related":["cipn-recovery-and-treatment","scrambler-therapy","rejuv-agenda-rehabilitation-not-commissioned","rejuv-agenda-nothing-restores-cognition","exercise-prescription-after-cancer","idea-moon-neuropathy-prevention-programme","rejuvenation-roadmap"],"cancers":[],"sections":["rejuvenation","supportive-care"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07481149","phase":"3","setting":"Adults with persistent chemotherapy-induced peripheral neuropathy after treatment, Canada","sponsor":"University Health Network, Toronto","started":"2026-03-30","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02767804","kind":"trial","name":"eXalt3","aka":["X396-CLI-301","eXALT3","eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients"],"tldr":"eXalt3 showed that ensartinib, a second-generation ALK pill, kept ALK-positive lung cancer under control about twice as long as crizotinib, with useful activity against brain metastases.","summary":"eXalt3 was an open-label, randomised phase 3 trial at 120 centres in 21 countries that compared ensartinib with crizotinib in 290 patients with advanced, recurrent or metastatic ALK-positive non-small-cell lung cancer who had not received an ALK inhibitor. Patients were randomised 1:1 to ensartinib 225 mg once daily (143) or crizotinib 250 mg twice daily (147). The primary endpoint was progression-free survival by blinded independent review, assessed in the intent-to-treat population and in a prespecified modified population with central-laboratory-confirmed ALK-positive disease.\n\nIn the intent-to-treat population, median progression-free survival was 25.8 months with ensartinib against 12.7 months with crizotinib (hazard ratio 0.51, 95% CI 0.35 to 0.72); in the modified population it was not reached against 12.7 months (hazard ratio 0.45). Among patients with target brain metastases at baseline, the intracranial response rate was 63.6 percent (7 of 11) against 21.1 percent (4 of 19) (JAMA Oncology 2021). The US label reports the same medians with a hazard ratio of 0.56 (95% CI 0.40 to 0.79) from its own analysis, response rates of 74 percent against 67 percent, median duration of response not estimable against 27.3 months among 106 and 98 responders, and a final overall survival of 63.2 against 55.7 months (hazard ratio 0.88, 95% CI 0.63 to 1.23) that was not statistically significant.\n\nThe trial supported the December 2024 US first-line approval of ensartinib (Ensacove). It compared ensartinib with crizotinib, not with alectinib or lorlatinib; ALEX, ALTA-1L and CROWN set the first-line benchmarks for the other next-generation inhibitors. The registry still lists the study as active and no longer recruiting for long-term follow-up.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02767804","url":"https://clinicaltrials.gov/study/NCT02767804"},{"label":"JAMA Oncology 2021","url":"https://doi.org/10.1001/jamaoncol.2021.3523"},{"label":"Ensacove label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e1b2f79-678a-472a-b924-66909c8a4b2e"}],"tags":[],"related":["alex","alta-1l","crown"],"cancers":["nsclc","alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["ensartinib","crizotinib"],"companies":["xcovery"],"institutions":[],"pathways":[],"terms":["brain-metastases","tki-term"],"trials":[],"people":["tony-mok","martin-reck","heather-wakelee"],"bottlenecks":[],"keyPapers":["paper-nct02767804-jama-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02767804","phase":"3","setting":"Advanced ALK-positive non-small-cell lung cancer with no prior ALK inhibitor: ensartinib versus crizotinib","sponsor":"Xcovery Holdings, Inc.","result":"Median progression-free survival 25.8 vs 12.7 months (hazard ratio 0.51, blinded independent review, intent-to-treat); intracranial response 63.6% vs 21.1% in patients with target brain metastases.","started":"2016-06","startedType":"actual","yearReported":2021,"enrolled":290,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (blinded independent review, intent-to-treat)","primary":true,"unit":"months","arms":[{"name":"Ensartinib","n":143,"value":25.8},{"name":"Crizotinib","n":147,"value":12.7}],"hr":0.51,"ci":[0.35,0.72],"source":"https://doi.org/10.1001/jamaoncol.2021.3523"},{"endpoint":"Intracranial response rate (blinded independent review, target brain metastases at baseline)","unit":"%","arms":[{"name":"Ensartinib","n":11,"value":63.6,"note":"7 of 11"},{"name":"Crizotinib","n":19,"value":21.1,"note":"4 of 19"}],"source":"https://doi.org/10.1001/jamaoncol.2021.3523"},{"endpoint":"Objective response rate (blinded independent central review, US label)","unit":"%","arms":[{"name":"Ensartinib","n":143,"value":74,"note":"95% CI 66 to 81"},{"name":"Crizotinib","n":147,"value":67,"note":"95% CI 58 to 74"}],"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e1b2f79-678a-472a-b924-66909c8a4b2e"}],"replication":"No other trial compared ensartinib with crizotinib first line; ALEX, ALTA-1L and CROWN compared other next-generation ALK inhibitors with crizotinib instead."},{"id":"exam","kind":"trial","name":"EXAM","aka":[],"tldr":"EXAM showed that cabozantinib, which blocks RET, MET and VEGF receptors, held back progressive medullary thyroid cancer for far longer than placebo, and gave the disease its second approved targeted drug.","summary":"Medullary thyroid cancer arises from calcitonin-producing C cells and is driven by RET mutations in the hereditary and about half of sporadic cases. EXAM randomised 330 patients with documented progressive metastatic medullary thyroid cancer two to one to cabozantinib 140 mg daily or placebo, with progression-free survival as the primary endpoint.\n\nCabozantinib lengthened progression-free survival several-fold and produced objective responses in a substantial minority, regardless of RET mutation status, at the cost of diarrhoea, hand-foot syndrome, fatigue and hypertension. Overall survival was not significantly different in the whole population. It was approved in the United States in November 2012, following vandetanib (ZETA) as the second multikinase inhibitor for the disease; the selective RET inhibitors selpercatinib and pralsetinib have since displaced both for RET-mutant tumours.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00704730","url":"https://clinicaltrials.gov/study/NCT00704730"}],"tags":["subtype-trials"],"related":[],"cancers":["medullary-thyroid-cancer","thyroid"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["cabozantinib"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["rossella-elisei"],"bottlenecks":[],"keyPapers":["paper-exam-cabozantinib-mtc-elisei-jco-2013"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00704730","phase":"3","setting":"Progressive metastatic medullary thyroid cancer: cabozantinib against placebo","sponsor":"Exelixis","result":"Cabozantinib lengthened progression-free survival compared with placebo in progressive medullary thyroid cancer; approved in November 2012.","started":"2008-06","yearReported":2012,"enrolled":330,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Cabozantinib 140 mg","value":11.2},{"name":"Placebo","value":4}],"hr":0.28,"ci":[0.19,0.4],"p":"<0.001","source":"https://doi.org/10.1200/JCO.2012.48.4659"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Cabozantinib 140 mg","value":28},{"name":"Placebo","value":0}],"source":"https://doi.org/10.1200/JCO.2012.48.4659"},{"endpoint":"Alive and progression-free at 1 year","unit":"%","arms":[{"name":"Cabozantinib 140 mg","value":47.3},{"name":"Placebo","value":7.2}],"source":"https://doi.org/10.1200/JCO.2012.48.4659"}]},{"id":"nct06145074","kind":"trial","name":"Examining Safety, Efficacy and Feasibility of Preoperative Propranolol in Patients With PDAC.","aka":["IMPULS"],"tldr":"A phase 2 trial of propranolol (Hemangeol) in pancreatic cancer, run by Zealand University Hospital, now recruiting.","summary":"Examining Safety, Efficacy and Feasibility of Preoperative Propranolol in Patients With PDAC. is a phase 2, randomised interventional study registered as NCT06145074 by Zealand University Hospital, with a registry enrolment figure of 30 participants, started 2024-03-20 and due to reach its primary completion in 2026-12-31. Interventions recorded: Propranolol; Placebo. Conditions listed: Pancreatic Cancer; Surgery. Primary outcome: Preoperative anxiety; Preoperative anxiety and depression; Preoperative quality of life. Pancreatic eligibility wording from the registry: \"* Patients with suspected surgically resectable pancreatic cancer\". Sites: Denmark. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06145074","url":"https://clinicaltrials.gov/study/NCT06145074"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["propranolol-hemangeol"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06145074","phase":"2","setting":"Examining the Impact of Propranolol on Preoperative Anxiety and on Tumorigenic Changes in Patients With Pancreatic Ductal Adenocarcinomas: a Randomized, Triple-blinded, Placebo-controlled Pilot Trial","sponsor":"Zealand University Hospital","started":"2024-03-20","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06448572","kind":"trial","name":"EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy.","aka":["EXLIBRIS"],"tldr":"A phase 1/2 trial in lung cancer, run by University Hospital, Lille, now recruiting.","summary":"EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy. is a phase 1/2, interventional study registered as NCT06448572 by University Hospital, Lille, with a registry enrolment figure of 21 participants, started 2024-07-16 and due to reach its primary completion in 2028-10-01. Interventions recorded: EXL01. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Progression-free survival rate (PFS Rate) for the assessment of efficacy, defined as the rate of alive and non-progressive subjects as per iRECIST 1.1 over the study subjects.. Lung eligibility wording from the registry: \"Histologically or cytologically documented inoperable advanced/metastatic NSCLC\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06448572","url":"https://clinicaltrials.gov/study/NCT06448572"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06448572","phase":"1/2","setting":"EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy","sponsor":"University Hospital, Lille","started":"2024-07-16","startedType":"actual","enrolled":21,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02260817","kind":"trial","name":"Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Choline C-11 in Prostate cancer, run by Global Isotopes, LLC d/b/a Zevacor Molecular, completed.","summary":"Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer is a phase 3 interventional study registered as NCT02260817 by Global Isotopes, LLC d/b/a Zevacor Molecular, with 109 participants recorded, started 2014-10 and reaching its primary completion in 2016-06. Interventions recorded: 11C-choline Injection. Conditions recorded: Metastatic Prostate Cancer.\n\nLinked to the drug Choline C-11 because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02260817","url":"https://clinicaltrials.gov/study/NCT02260817"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["choline-c11"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02260817","phase":"3","setting":"Expanded Access to 11C Choline PET/CT and 11C Choline PET/MR for Staging of Recurrent Prostate Cancer With Comparison Study of CT and MR Modalities","sponsor":"Global Isotopes, LLC d/b/a Zevacor Molecular","started":"2014-10","startedType":"actual","yearReported":2019,"enrolled":109,"enrolledBasis":"registry","outcomes":[{"endpoint":"Sensitivity of 11C Choline PET Imaging Scans","primary":true,"unit":"%","arms":[{"name":"11C-choline Comparison Study of CT and MR Modalities","n":58,"value":97.29,"note":"Figures from the ClinicalTrials.gov results section (first posted 2019-12-17), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT02260817?tab=results"}]},{"id":"nct06440902","kind":"trial","name":"Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA","aka":[],"tldr":"A phase 2 trial of cetuximab in colorectal cancer, run by Fudan University, now recruiting.","summary":"Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA is a phase 2, interventional study registered as NCT06440902 by Fudan University, with a registry enrolment figure of 1100 participants, started 2023-12-28 and due to reach its primary completion in 2028-09-01. Interventions recorded: Cetuximab. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Detection rate of NeoRAS WT. Colorectal eligibility wording from the registry: \"Metastatic colorectal cancer with tissue RAS mutation-type;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06440902","url":"https://clinicaltrials.gov/study/NCT06440902"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["monoclonal-antibody","mrd-testing"],"targets":[],"drugs":["cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06440902","phase":"2","setting":"Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA: an Open, Prospective, Phase II Study","sponsor":"Fudan University","started":"2023-12-28","startedType":"actual","enrolled":1100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06427239","kind":"trial","name":"Exploratory Clinical Study of HRS-4642 Combined With Adebrelimab in the Treatment of Advanced Pancreatic Ductal Adenocarcinoma","aka":[],"tldr":"A phase 1/2 trial of adebrelimab and SHR-8068 in pancreatic cancer, run by Fudan University, now recruiting.","summary":"Exploratory Clinical Study of HRS-4642 Combined With Adebrelimab in the Treatment of Advanced Pancreatic Ductal Adenocarcinoma is a phase 1/2, interventional study registered as NCT06427239 by Fudan University, with a registry enrolment figure of 130 participants, started 2024-06-17 and due to reach its primary completion in 2027-06. Interventions recorded: HRS-4642; Adebrelimab; SHR-8068; Faminitib or bevacizumab. Conditions listed: Pancreatic Cancer. Primary outcome: Dose Limited Toxicity (DLT); Recommended phase II dose (RP2D); Objective Response Rate (ORR). Pancreatic eligibility wording from the registry: \"Advanced (metastatic or unresectable) Pancreatic ductal adenocarcinoma; and subjects must have at least one measurable lesion as defined by RECIST v1\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06427239","url":"https://clinicaltrials.gov/study/NCT06427239"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab","shr-8068"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06427239","phase":"1/2","setting":"A Single-center, Open-label, Exploratory Study of HRS-4642 Combined With Adebrelimab, or With Adebrelimab and Other Antitumor Agents in the Treatment of Advanced Pancreatic Ductal Adenocarcinoma","sponsor":"Fudan University","started":"2024-06-17","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06547736","kind":"trial","name":"Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of adebrelimab in pancreatic cancer, run by Fudan University, now recruiting.","summary":"Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT06547736 by Fudan University, with a registry enrolment figure of 160 participants, started 2024-10-14 and due to reach its primary completion in 2027-03. Interventions recorded: SHR-A2102 or/and HRS-4642; SHR-A1904 or/and HRS-4642; SHR-A1811 or/and HRS-4642; SHR-A2102, HRS4642 and Adebrelimab. Conditions listed: Pancreatic Cancer. Primary outcome: Recommended phase II dose (RP2D); Objective Response Rate (ORR). Pancreatic eligibility wording from the registry: \"Advanced (metastatic or unresectable) pancreatic cancer; and subjects must have at least one measurable lesion as defined by RECIST v1\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06547736","url":"https://clinicaltrials.gov/study/NCT06547736"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06547736","phase":"2","setting":"A Single-center, Open-label, Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer","sponsor":"Fudan University","started":"2024-10-14","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07146672","kind":"trial","name":"Exploratory Study of Super DC Cell Injection in Preventing Recurrence After Radical Surgery for Tumors","aka":[],"tldr":"A phase 1/2 trial of Super DC Vaccine in advanced solid tumours, run by Shanghai Cell Therapy Group Co.,Ltd, now recruiting.","summary":"Exploratory Study of Super DC Cell Injection in Preventing Recurrence After Radical Surgery for Tumors is a phase 1/2 interventional study registered as NCT07146672 by Shanghai Cell Therapy Group Co.,Ltd, with 12 participants planned, started 2025-07-31 and due to reach its primary completion in 2026-12-31. Interventions recorded: Super DC Vaccine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07146672","url":"https://clinicaltrials.gov/study/NCT07146672"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["dendritic-cell-vaccines"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07146672","phase":"1/2","setting":"Exploratory Study of Super DC Cell Injection in Preventing Recurrence After Radical Surgery for Tumors","sponsor":"Shanghai Cell Therapy Group Co.,Ltd","started":"2025-07-31","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07631884","kind":"trial","name":"Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor","aka":[],"tldr":"A phase 2 trial of trastuzumab rezetecan in gallbladder cancer and other biliary tract cancers, run by Haihua Yuan, not yet recruiting.","summary":"Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor is a phase 2 interventional study registered as NCT07631884 by Haihua Yuan, with a registry enrolment figure of 15 participants, started 2026-06-15 and due to reach its primary completion in 2028-12-31. Interventions recorded: Trastuzumab Rezetecan. Conditions listed: Solid Tumors, Neoplasms (Cancer / Tumors), Advanced Malignant Solid Neoplasm, Locally Advanced Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, HER2 Expression, Biliary Tract Neoplasms, Endometrial Neoplasms, Urothelial Carcinoma (UC), Pancreatic Neoplasms, Colorectal Neoplasms, Gastric Neoplasms, Non-Small Cell Lung Carcinoma (NSCLC), Head and Neck Neoplasms, Cervical Neoplasms. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07631884","url":"https://clinicaltrials.gov/study/NCT07631884"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-rezetecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07631884","phase":"2","setting":"Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor","sponsor":"Haihua Yuan","started":"2026-06-15","startedType":"estimated","enrolled":15,"enrolledBasis":"registry","outcomes":[]},{"id":"explorer","kind":"trial","name":"EXPLORER","aka":["BLU-285-2101"],"tldr":"EXPLORER was the first human study of avapritinib, a pill designed to block the KIT D816V mutation that drives almost every case of advanced systemic mastocytosis; three quarters of evaluable patients responded and a third went into complete remission, and the drug was approved for the disease in 2021.","summary":"EXPLORER was a phase 1 dose-escalation and expansion study of avapritinib (BLU-285), a selective inhibitor of KIT D816V, in 86 patients with advanced systemic mastocytosis or relapsed myeloid malignancies, 69 of whom had centrally confirmed advanced systemic mastocytosis. The primary endpoints were the maximum tolerated dose, the recommended phase 2 dose and safety; response rate and measures of mast cell burden were secondary.\n\nThe maximum tolerated dose was not reached and 200 mg and 300 mg daily were studied in expansion. Among 53 response-evaluable patients the overall response rate was 75 percent with a complete remission rate of 36 percent, and avapritinib halved marrow mast cells and serum tryptase in almost every patient. Periorbital oedema, anaemia, diarrhoea and thrombocytopenia were the common adverse events; intracranial bleeding occurred in 13 percent overall but in 1 percent of patients without severe thrombocytopenia, which is why the label requires a platelet count of 50 x 10^9/L or more. Together with the phase 2 PATHFINDER trial it supported approval of avapritinib for advanced systemic mastocytosis in the United States in June 2021.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02561988","url":"https://clinicaltrials.gov/study/NCT02561988"}],"tags":["soc-trials"],"related":[],"cancers":["advanced-systemic-mastocytosis","systemic-mastocytosis"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["avapritinib"],"companies":["blueprint-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-explorer-avapritinib-advanced-systemic-mastocytosis-nat-med-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02561988","phase":"1","setting":"Advanced systemic mastocytosis (aggressive systemic mastocytosis, mastocytosis with an associated haematological neoplasm, mast cell leukaemia) and relapsed myeloid malignancies: first-in-human dose escalation and expansion of the selective KIT D816V inhibitor avapritinib at 30 to 400 mg daily","sponsor":"Blueprint Medicines Corporation","result":"Overall response rate 75 percent and complete remission rate 36 percent in 53 evaluable patients with advanced systemic mastocytosis; maximum tolerated dose not reached; recommended dose 200 mg daily; approved June 2021.","started":"2016-03-10","startedType":"actual","yearReported":2021,"enrolled":86,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate (response-evaluable advanced systemic mastocytosis)","unit":"%","arms":[{"name":"Avapritinib 30 to 400 mg daily","n":53,"value":75}],"source":"https://doi.org/10.1038/s41591-021-01538-9"},{"endpoint":"Complete remission rate (response-evaluable advanced systemic mastocytosis)","unit":"%","arms":[{"name":"Avapritinib 30 to 400 mg daily","n":53,"value":36}],"source":"https://doi.org/10.1038/s41591-021-01538-9"},{"endpoint":"Reduction of 50% or more in serum tryptase","unit":"%","arms":[{"name":"Avapritinib 30 to 400 mg daily","value":99}],"source":"https://doi.org/10.1038/s41591-021-01538-9"},{"endpoint":"Intracranial bleeding","unit":"%","arms":[{"name":"Avapritinib, all patients","n":86,"value":13},{"name":"Avapritinib, patients without severe thrombocytopenia","value":1}],"source":"https://doi.org/10.1038/s41591-021-01538-9"},{"endpoint":"Periorbital oedema (any grade)","unit":"%","arms":[{"name":"Avapritinib 30 to 400 mg daily","n":86,"value":69}],"source":"https://doi.org/10.1038/s41591-021-01538-9"}]},{"id":"nct07007767","kind":"trial","name":"Exploring Sintilimab + Bevacizumab + Decitabine for Advanced pMMR/MSS Colorectal Cancer (After 2+ Prior Therapies）","aka":[],"tldr":"A phase 2 trial of sintilimab, bevacizumab and decitabine in colorectal cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, not yet recruiting.","summary":"Exploring Sintilimab + Bevacizumab + Decitabine for Advanced pMMR/MSS Colorectal Cancer (After 2+ Prior Therapies） is a phase 2, interventional study registered as NCT07007767 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 32 participants, started 2025-06-15 and due to reach its primary completion in 2026-12-30. Interventions recorded: sintilimab; Bevacizumab Biosimilar; Decitabine. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigator Assessment. Colorectal eligibility wording from the registry: \"Histologically confirmed colorectal adenocarcinoma;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07007767","url":"https://clinicaltrials.gov/study/NCT07007767"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["sintilimab","bevacizumab","decitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07007767","phase":"2","setting":"An Open-label, Single-arm, Exploratory Study of Sintilimab in Combination With Bevacizumab and Decitabine for the Treatment of Advanced pMMR/MSS Colorectal Cancer in Third-line or Later Settings","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2025-06-15","startedType":"estimated","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07105852","kind":"trial","name":"Exploring the Safety and Efficacy of Sacituzumab Tirumotecan Combined With Pucotenlimab in the Treatment of Advanced Cholangiocarcinoma","aka":[],"tldr":"A phase 2 trial of sacituzumab tirumotecan and pucotenlimab in gallbladder cancer and other biliary tract cancers, run by Sir Run Run Shaw Hospital, now recruiting.","summary":"Exploring the Safety and Efficacy of Sacituzumab Tirumotecan Combined With Pucotenlimab in the Treatment of Advanced Cholangiocarcinoma is a phase 2 interventional study registered as NCT07105852 by Sir Run Run Shaw Hospital, with a registry enrolment figure of 59 participants, started 2025-07-03 and due to reach its primary completion in 2027-07-01. Interventions recorded: Sacituzumab tirumotecan (iv)+Putolizumab injection (iv). Conditions listed: Cholangiocarcinoma. Gallbladder cancer is named in the registry entry: \"* 1\\. Age \\>= 18 years old; 2. Histologically confirmed unresectable or metastatic cholangiocarcinoma (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07105852","url":"https://clinicaltrials.gov/study/NCT07105852"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["sacituzumab-tirumotecan","pucotenlimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07105852","phase":"2","setting":"Exploring the Safety and Efficacy of Sacituzumab Tirumotecan Combined With Pucotenlimab in the Treatment of Advanced Cholangiocarcinoma","sponsor":"Sir Run Run Shaw Hospital","started":"2025-07-03","startedType":"actual","enrolled":59,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03441113","kind":"trial","name":"Extended Access of Momelotinib in Adults With Myelofibrosis","aka":[],"tldr":"A phase 2 trial of MMB in myeloproliferative neoplasms, run by GlaxoSmithKline, active and no longer recruiting.","summary":"Extended Access of Momelotinib in Adults With Myelofibrosis is a phase 2 interventional study registered as NCT03441113 by GlaxoSmithKline, with 237 participants enrolled, started 2018-05-03 and due to reach its primary completion in 2026-12-11. Interventions recorded: MMB.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03441113","url":"https://clinicaltrials.gov/study/NCT03441113"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","primary-myelofibrosis"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03441113","phase":"2","setting":"Extended Access of Momelotinib for Subjects With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)","sponsor":"GlaxoSmithKline","started":"2018-05-03","startedType":"actual","enrolled":237,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06593431","kind":"trial","name":"Extending Outcomes for Pancreas Cancer Patients With Nominal Oligometastatic Disease (EXPAND): A Randomized Phase III Trial","aka":["EXPAND"],"tldr":"A phase 3 trial in pancreatic cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"Extending Outcomes for Pancreas Cancer Patients With Nominal Oligometastatic Disease (EXPAND): A Randomized Phase III Trial is a phase 3, randomised interventional study registered as NCT06593431 by M.D. Anderson Cancer Center, with a registry enrolment figure of 80 participants, started 2024-10-23 and due to reach its primary completion in 2029-06-29. Interventions recorded: Consolidative Radiation. Conditions listed: Pancreas Cancer; Oligometastatic. Primary outcome: Safety and Adverse Events (AEs). Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed pancreatic ductal adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06593431","url":"https://clinicaltrials.gov/study/NCT06593431"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06593431","phase":"3","setting":"Extending Outcomes for Pancreas Cancer Patients With Nominal Oligometastatic Disease (EXPAND): A Randomized Phase III Trial","sponsor":"M.D. Anderson Cancer Center","started":"2024-10-23","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07405164","kind":"trial","name":"Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)","aka":["LITESPARK-043"],"tldr":"A phase 3 trial of Belzutifan, Nivolumab, Lenvatinib and Cabozantinib in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) is a phase 3 interventional study registered as NCT07405164 by Merck Sharp & Dohme LLC, with 450 participants planned, started 2026-03-23 and due to reach its primary completion in 2034-01-14. Interventions recorded: Belzutifan, Nivolumab, Lenvatinib and Cabozantinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07405164","url":"https://clinicaltrials.gov/study/NCT07405164"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["belzutifan","nivolumab","lenvatinib","cabozantinib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07405164","phase":"3","setting":"A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long-term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)","sponsor":"Merck Sharp & Dohme LLC","started":"2026-03-23","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04655092","kind":"trial","name":"Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients","aka":[],"tldr":"A phase 3 trial of Ropeginterferon alfa-2b in myeloproliferative neoplasms, run by PharmaEssentia Japan K.K., now recruiting.","summary":"Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients is a phase 3 interventional study registered as NCT04655092 by PharmaEssentia Japan K.K., with 67 participants planned, started 2021-01-19 and due to reach its primary completion in 2026-06-30. Interventions recorded: P1101 (Ropeginterferon alfa-2b).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04655092","url":"https://clinicaltrials.gov/study/NCT04655092"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","essential-thrombocythaemia","polycythaemia-vera"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["ropeginterferon-alfa-2b"],"companies":["pharmaessentia"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04655092","phase":"3","setting":"Extension Study of P1101 in Japanese Patients Who Have Completed Phase 2 Single Arm Study in Polycythemia Vera (PV) Patients (Study A19-201) or Phase 3 Study in Essential Thrombocythemia (ET) Patients (Study P1101 ET)","sponsor":"PharmaEssentia Japan K.K.","started":"2021-01-19","startedType":"actual","enrolled":67,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06465433","kind":"trial","name":"Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab","aka":[],"tldr":"A phase 2 trial of Tafasitamab in advanced solid tumours, run by Incyte Corporation, now recruiting.","summary":"Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab is a phase 2 interventional study registered as NCT06465433 by Incyte Corporation, with 25 participants planned, started 2022-11-08 and due to reach its primary completion in 2027-08-29. Interventions recorded: Tafasitamab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06465433","url":"https://clinicaltrials.gov/study/NCT06465433"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["tafasitamab"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06465433","phase":"2","setting":"An Open-Label, Multicenter, Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab","sponsor":"Incyte Corporation","started":"2022-11-08","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04930653","kind":"trial","name":"Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma","aka":[],"tldr":"A phase 2 trial of Methoxsalen and Mogamulizumab in Cutaneous T-cell lymphoma, Peripheral T-cell lymphomas and Non-Hodgkin lymphoma, run by City of Hope Medical Center, now recruiting.","summary":"Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma is a phase 2 interventional study registered as NCT04930653 by City of Hope Medical Center, with 34 participants planned, started 2022-10-19 and due to reach its primary completion in 2028-06-15. Interventions recorded: Extracorporeal Photopheresis, Mogamulizumab, Quality-of-Life Assessment, Questionnaire Administration. Conditions recorded: Folliculotropic Mycosis Fungoides, Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Sezary Syndrome, Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8, Transformed Mycosis Fungoides.\n\nLinked to the drug Methoxsalen because the registry names it among its interventions and Cutaneous T-cell lymphoma, Peripheral T-cell lymphomas and Non-Hodgkin lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04930653","url":"https://clinicaltrials.gov/study/NCT04930653"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cutaneous-t-cell-lymphoma","peripheral-t-cell-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["methoxsalen-ecp","mogamulizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04930653","phase":"2","setting":"A Phase II Study of Combination Extracorporeal Photopheresis (ECP) and Mogamulizumab in Erythrodermic CTCL","sponsor":"City of Hope Medical Center","started":"2022-10-19","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"extreme","kind":"trial","name":"EXTREME","aka":[],"tldr":"The regimen that defined first-line treatment for advanced head and neck cancer from 2008 until immunotherapy replaced it.","summary":"EXTREME, trial NCT00122460 sponsored by Merck KGaA and reported in 2008, produced the regimen that defined first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma from 2008 until immunotherapy replaced it. It randomised 442 patients to cetuximab plus platinum and fluorouracil or chemotherapy alone and met its primary overall survival endpoint, the first survival gain in this setting in decades, and it became the control arm for KEYNOTE-048. OnCo links it to head and neck cancer, monoclonal antibodies, platinum agents, EGFR as a target, Jan B. Vermorken and KEYNOTE-048, and the docetaxel-based TPExtreme regimen matched it. Whether cetuximab retains any first-line role now that pembrolizumab-based regimens are standard is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00122460","url":"https://clinicaltrials.gov/study/NCT00122460"},{"label":"NEJM 2008","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa0802656"}],"tags":[],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["monoclonal-antibody","platinum"],"targets":["egfr"],"drugs":[],"companies":["merck-kgaa"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jan-vermorken"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00122460","phase":"3","setting":"Untreated recurrent or metastatic HNSCC: cetuximab + platinum/5-FU vs platinum/5-FU","sponsor":"Merck KGaA","result":"OS 10.1 vs 7.4 months; HR 0.80.","started":"2004-12","yearReported":2008,"enrolled":442,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Cetuximab + chemotherapy","value":10.1},{"name":"Chemotherapy","value":7.4}],"hr":0.8,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa0802656"}],"replication":"TPExtreme (docetaxel-based) matched it; the regimen was robust until superseded."},{"id":"nct05760378","kind":"trial","name":"Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC.","aka":[],"tldr":"A phase 3 trial of camrelizumab, capecitabine, eribulin and carboplatin in triple-negative breast cancer, run by Fudan University, now recruiting.","summary":"Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC. is a phase 3, randomised interventional study registered as NCT05760378 by Fudan University, with a registry enrolment figure of 223 participants, started 2023-03-17 and due to reach its primary completion in 2025-01-01. Interventions recorded: Famitinib; Camrelizumab; nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin. Conditions listed: Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05760378","url":"https://clinicaltrials.gov/study/NCT05760378"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["camrelizumab","capecitabine","eribulin","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05760378","phase":"3","setting":"An Open, Randomized Phase III Study of Famitinib With Camrelizumab Plus Treatment of Physician's Choice (TPC) Versus Camrelizumab Plus TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic Triple-negative Breast Cancer","sponsor":"Fudan University","started":"2023-03-17","startedType":"actual","enrolled":223,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07705074","kind":"trial","name":"FAPI PET Imaging - An Exploratory Study","aka":["FAPIPET"],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Martin Huellner, not yet recruiting.","summary":"FAPI PET Imaging - An Exploratory Study is a phase 1/2, interventional study registered as NCT07705074 by Martin Huellner, with a registry enrolment figure of 770 participants, started 2026-08 and due to reach its primary completion in 2029-09. Interventions recorded: [18F]FAPI-74 PET/CT. Conditions listed: Thyroid Pathology; Head and Neck Cancer (H&N); Sinonasal Tract Tumor; Sarcoidosis; Thyroid Cancer; Breast Cancer; Hepatocellular Carcinoma (HCC); Gastric Cancer (GC); Pancreatic Cancer, Adult; Urothelial Carcinoma (UC); Multiple Myeloma or Plasmacytoma; Mesothelioma; Hepatic Fibrosis; Endometriosis (Diagnosis); Lung Fibrosis; Neck Node Metastasis; Prostate Cancer (CRPC). Primary outcome: Diagnostic Interpretability and Uptake Classification of [18F]FAPI-74 PET Imaging. Sites: Switzerland. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07705074","url":"https://clinicaltrials.gov/study/NCT07705074"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07705074","phase":"1/2","setting":"FAPI PET Imaging - a Multicentric Exploratory Evaluation","sponsor":"Martin Huellner","started":"2026-08","startedType":"estimated","enrolled":770,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07815834","kind":"trial","name":"FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02)","aka":["TORCH-PM02"],"tldr":"A phase 3 trial of cadonilimab in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02) is a phase 3, randomised interventional study registered as NCT07815834 by Fudan University, with a registry enrolment figure of 198 participants, started 2026-09-01 and due to reach its primary completion in 2030-08-01. Interventions recorded: Second-Line Chemotherapy; Radiation Therapy; Cadonilimab (AK104). Conditions listed: Colon Rectal Cancer Adenocarcinoma; Peritoneal (Metastatic) Cancer; Second-line Treatment; Radiation Therapy; Immunotherapy. Primary outcome: Progression-Free Survival (PFS). Colorectal eligibility wording from the registry: \"Histopathologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07815834","url":"https://clinicaltrials.gov/study/NCT07815834"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["cadonilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07815834","phase":"3","setting":"FAPI-Guided Hypofractionated Radiotherapy Combined With Cadonilimab and Standard Second-Line Chemotherapy Versus Standard Second-Line Chemotherapy for Peritoneal Metastasis From Colorectal Cancer: A Multicenter, Randomized, Open-Label, Phase III Trial (TORHC-PM02)","sponsor":"Fudan University","started":"2026-09-01","startedType":"estimated","enrolled":198,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07478523","kind":"trial","name":"FAPI-PET Value for the Initial Screening of Pancreatic and Biliary Cancers","aka":["FAPDIG"],"tldr":"A phase 2 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by University Hospital, Bordeaux, now recruiting.","summary":"FAPI-PET Value for the Initial Screening of Pancreatic and Biliary Cancers is a phase 2 interventional study registered as NCT07478523 by University Hospital, Bordeaux, with a registry enrolment figure of 120 participants, started 2026-04-21 and due to reach its primary completion in 2028-03-21. Interventions recorded: TEP-TDM au 68Ga-FAPI-46. Conditions listed: Cholangiocarcinoma, Pancreatic Adenocarcinoma. Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07478523","url":"https://clinicaltrials.gov/study/NCT07478523"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07478523","phase":"2","setting":"Diagnostic Value of 68Ga-FAPI-46 PET/CT in the Initial Work-up of Pancreatic and Biliary Cancers Eligible to a Curative Treatment","sponsor":"University Hospital, Bordeaux","started":"2026-04-21","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"fast-trial","kind":"trial","name":"FAST (5-fraction whole-breast radiotherapy)","aka":["FAST trial","CRUKE/04/015"],"tldr":"FAST is the trial that found the right five-dose schedule by measuring what the breast looked like afterwards. Giving the five treatments one a week, it showed 28.5 Gy leaves the breast no more changed than five weeks of conventional treatment, while 30 Gy leaves it visibly worse.","summary":"FAST recruited 915 women aged 50 or over with low-risk pT1 to pT2 pN0 invasive breast cancer from 18 United Kingdom centres between 2004 and 2007, and randomised them to 50 Gy in twenty-five fractions or to 30 Gy or 28.5 Gy in five once-weekly fractions of 6.0 or 5.7 Gy. Its primary endpoint was not survival or recurrence but change in photographic breast appearance at two and five years, because the question it was built to answer was how large a single fraction the normal breast will tolerate.\n\nFive-year photographs were available for 615 of 862 eligible patients (71 percent). The odds ratio for change in photographic breast appearance against 50 Gy was 1.64 (95 percent confidence interval 1.08 to 2.49, p=0.019) for 30 Gy and 1.10 (0.70 to 1.71, p=0.686) for 28.5 Gy. For any moderate or marked physician-assessed normal-tissue effect the odds ratios were 2.12 (1.55 to 2.89, p<0.001) for 30 Gy and 1.22 (0.87 to 1.72, p=0.248) for 28.5 Gy.\n\nThe estimate that carried the field forward came out of the dose response: an alpha to beta ratio of 2.7 Gy (1.5 to 3.9) for the photographic endpoint, which implies a five-fraction schedule of 28 Gy (26 to 30) is equivalent to 50 Gy in twenty-five. That estimate is why FAST-Forward tested 26 and 27 Gy, and why 26 Gy in five fractions over one week is now the default in England.\n\nCancer outcomes are reported but the trial was never powered for them: at a median 9.9 years there had been eleven ipsilateral breast cancer events (three, four and four across the arms) and 96 deaths.","status":"positive","asOf":"2026-09-25","links":[{"label":"FAST ten-year results (Journal of Clinical Oncology 2020)","url":"https://doi.org/10.1200/JCO.19.02750"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["hypofractionated-radiotherapy","imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":["icr-london"],"pathways":[],"terms":["hypofractionation","alpha-beta-ratio"],"trials":["fast-forward","start-a","start-b"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Women aged 50 or over with low-risk invasive breast carcinoma, pT1 to pT2 pN0, after breast-conserving surgery: 30 Gy or 28.5 Gy in five once-weekly fractions against 50 Gy in twenty-five fractions, with change in photographic breast appearance at two and five years as the primary endpoint","sponsor":"Institute of Cancer Research, United Kingdom, funded by Cancer Research UK","result":"At ten years, 28.5 Gy in five once-weekly fractions gave normal-tissue effects no worse than 50 Gy in twenty-five (odds ratio 1.22, 0.87 to 1.72), while 30 Gy was worse (2.12, 1.55 to 2.89); the alpha to beta ratio was estimated at 2.7 Gy.","yearReported":2020,"enrolled":915,"enrolledBasis":"randomised","enrolledNote":"915 women were recruited from 18 United Kingdom centres between 2004 and 2007; the trial carries the Cancer Research UK reference CRUKE/04/015 and no ClinicalTrials.gov registration.","outcomes":[{"endpoint":"Change in photographic breast appearance at 5 years against 50 Gy in 25 fractions","primary":true,"unit":"odds ratio","arms":[{"name":"30 Gy in 5 once-weekly fractions","value":1.64,"note":"95 percent confidence interval 1.08 to 2.49, p=0.019"},{"name":"28.5 Gy in 5 once-weekly fractions","value":1.1,"note":"95 percent confidence interval 0.70 to 1.71, p=0.686"}],"source":"https://doi.org/10.1200/JCO.19.02750"},{"endpoint":"Any moderate or marked physician-assessed normal-tissue effect against 50 Gy in 25 fractions","unit":"odds ratio","arms":[{"name":"30 Gy in 5 once-weekly fractions","value":2.12,"note":"95 percent confidence interval 1.55 to 2.89, p<0.001"},{"name":"28.5 Gy in 5 once-weekly fractions","value":1.22,"note":"95 percent confidence interval 0.87 to 1.72, p=0.248"}],"source":"https://doi.org/10.1200/JCO.19.02750"}],"replication":"FAST-Forward tested 26 and 27 Gy in five daily fractions in 4,096 women and found 26 Gy non-inferior for local control with normal-tissue effects like the three-week standard."},{"id":"fast-forward","kind":"trial","name":"FAST-Forward","aka":[],"tldr":"FAST-Forward cut breast radiotherapy to five treatments in a single week and showed the same low relapse rate as the three-week standard, with similar late effects at five years.","summary":"FAST-Forward randomised 4,096 women with early breast cancer to 40 Gy in 15 fractions, 27 Gy in five or 26 Gy in five fractions over one week. Five-year ipsilateral breast tumour relapse was 2.1 percent after 40 Gy and 1.4 percent after 26 Gy, meeting the non-inferiority margin; late normal-tissue effects after 26 Gy were similar to the standard arm while 27 Gy gave more (Murray Brunt and colleagues, Lancet 2020). One-week radiotherapy became standard in the UK and, accelerated by the pandemic, widely elsewhere.","status":"positive","asOf":"2026-09-16","links":[{"label":"ISRCTN19906132","url":"https://www.isrctn.com/ISRCTN19906132"},{"label":"Lancet 2020","url":"https://doi.org/10.1016/S0140-6736(20)30932-6"}],"tags":["radiation-wave2"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive","tnbc","breast-cancer"],"sections":[],"technologies":["hypofractionated-radiotherapy","imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["hypofractionation","post-mastectomy-radiotherapy","partial-breast-irradiation"],"trials":["fast-trial","start-a"],"people":[],"bottlenecks":[],"keyPapers":["paper-murray-brunt-lancet"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Early breast cancer after surgery: 26 Gy in five fractions over one week versus 40 Gy in 15 fractions over three weeks","sponsor":"Institute of Cancer Research (UK)","result":"5-year ipsilateral breast tumour relapse 1.4% (26 Gy in 5) vs 2.1% (40 Gy in 15), non-inferior.","yearReported":2020,"enrolled":4096,"enrolledBasis":"registry","outcomes":[{"endpoint":"Ipsilateral breast tumour relapse at 5 years","primary":true,"unit":"%","arms":[{"name":"26 Gy in 5 fractions","n":1368,"value":1.4},{"name":"40 Gy in 15 fractions","n":1361,"value":2.1}]}]},{"id":"nct06858618","kind":"trial","name":"FCN-338 in Combination With Azacitidine or Chemotherapy in Myeloid Neoplasms","aka":[],"tldr":"A phase 2 trial of Azacitidine in advanced solid tumours, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., active and no longer recruiting.","summary":"FCN-338 in Combination With Azacitidine or Chemotherapy in Myeloid Neoplasms is a phase 2 interventional study registered as NCT06858618 by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., with 47 participants enrolled, started 2023-08-16 and due to reach its primary completion in 2026-12-01. Interventions recorded: FCN-338 + Azacitidine and FCN-338 + erythromycin+ Ara-C.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06858618","url":"https://clinicaltrials.gov/study/NCT06858618"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["azacitidine"],"companies":["shanghai-fosun-pharmaceutical-industrial-development"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06858618","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Safety & Tolerability, Antitumor Activity, and Pharmacokinetics of FCN-338 in Combination With Azacitidine or Chemotherapy in Patients With Myeloid Neoplasms","sponsor":"Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.","started":"2023-08-16","startedType":"actual","enrolled":47,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06519370","kind":"trial","name":"FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer","aka":[],"tldr":"A phase 3 trial testing FDA018-ADC in triple-negative breast cancer, active and no longer recruiting.","summary":"FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer is a phase 3 interventional study registered as NCT06519370, led by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, and active but no longer recruiting on the registry. Official title: A Phase 3, Open-label, Randomised Study of FDA018-ADC Versus Investigator's Choice of Chemotherapy in Patients Who Recurred During or After Taxane Therapy in Locally Advanced or Metastatic Triple-negative Breast Cancer. Planned enrolment is 350 participants (estimated). The study started in 2024-08-09 and primary completion is expected in 2026-08-18. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06519370","url":"https://clinicaltrials.gov/study/NCT06519370"}],"tags":["ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["fda018-adc"],"companies":[],"institutions":["fuscc"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06519370","phase":"3","setting":"A Phase 3, Open-label, Randomised Study of FDA018-ADC Versus Investigator's Choice of Chemotherapy in Patients Who Recurred During or After Taxane Therapy in Locally Advanced or Metastatic Triple-negative Breast Cancer","sponsor":"Shanghai Fudan-Zhangjiang Bio-Pharmaceutical","started":"2024-08-09","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02584244","kind":"trial","name":"Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers","aka":[],"tldr":"A phase 1/2 trial of LUM015 in colorectal cancer, pancreatic ductal adenocarcinoma, oesophageal cancer and gastric & gastro-oesophageal junction cancer, run by Lumicell, Inc., now recruiting.","summary":"Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers is a phase 1/2 interventional study registered as NCT02584244 by Lumicell, Inc., with 66 participants planned, started 2016-08-04 and due to reach its primary completion in 2026-12. Interventions recorded: LUM015 and LUM 2.6 Imaging Device.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02584244","url":"https://clinicaltrials.gov/study/NCT02584244"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","pancreatic","esophageal","gastric"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["lumicell"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02584244","phase":"1/2","setting":"Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers","sponsor":"Lumicell, Inc.","started":"2016-08-04","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03290534","kind":"trial","name":"Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®","aka":[],"tldr":"A phase 2 trial of CivaSheet in advanced solid tumours, run by CivaTech Oncology, now recruiting.","summary":"Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet® is a phase 2 interventional study registered as NCT03290534 by CivaTech Oncology, with 40 participants planned, started 2019-03-13 and due to reach its primary completion in 2026-12. Interventions recorded: CivaSheet.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03290534","url":"https://clinicaltrials.gov/study/NCT03290534"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["civatech-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03290534","phase":"2","setting":"Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®","sponsor":"CivaTech Oncology","started":"2019-03-13","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05502913","kind":"trial","name":"Fecal Microbiota Transplantation With Immune Checkpoint Inhibitors in Lung Cancer","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Soroka University Medical Center, now recruiting.","summary":"Fecal Microbiota Transplantation With Immune Checkpoint Inhibitors in Lung Cancer is a phase 2, randomised interventional study registered as NCT05502913 by Soroka University Medical Center, with a registry enrolment figure of 80 participants, started 2023-09-01 and due to reach its primary completion in 2025-06-30. Interventions recorded: Antibiotics; FMT (Fecal Microbiota Transplantation). Conditions listed: Metastatic Lung Cancer. Primary outcome: Progression-free Survival (PFS). Sites: Israel. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05502913","url":"https://clinicaltrials.gov/study/NCT05502913"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05502913","phase":"2","setting":"Fecal Microbiota Transplantation to Improve Efficacy of Immune Checkpoint Inhibitors in Metastatic Lung Cancer","sponsor":"Soroka University Medical Center","started":"2023-09-01","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"felix","kind":"trial","name":"FELIX","aka":[],"tldr":"The trial that showed a gentler CAR-T design could treat adult ALL with a fraction of the severe side effects.","summary":"FELIX, trial NCT04404660 sponsored by Autolus and published in the New England Journal of Medicine in 2024, showed that a gentler CAR-T design, obecabtagene autoleucel, could treat adult relapsed or refractory B-cell acute lymphoblastic leukaemia with a fraction of the severe side effects of earlier products. Of 153 enrolled, 127 were infused; the overall remission rate was 77 percent with complete remission in 55 percent, severe cytokine release syndrome occurred in under three percent, and about forty percent were event-free at two years, most without transplant, leading to FDA approval on 8 November 2024 without a REMS programme. OnCo links it to acute lymphoblastic leukaemia, CAR-T, CD19 as a target and obecabtagene autoleucel, and the UCL predecessor ALLCAR19 showed the same profile. Whether the fast-off-rate design generalises to other CAR-T targets is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04404660","url":"https://clinicaltrials.gov/study/NCT04404660"}],"tags":[],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":["car-t"],"targets":["cd19"],"drugs":["obecabtagene-autoleucel"],"companies":["autolus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04404660","phase":"1/2","setting":"Relapsed or refractory B-ALL, adults: obecabtagene autoleucel single split-dose course","sponsor":"Autolus","result":"ORR 77%, CR 55%; grade ≥3 CRS 2.4%.","started":"2020-06-03","startedType":"actual","yearReported":2024,"enrolled":153,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall remission (CR + CRi)","primary":true,"unit":"%","arms":[{"name":"Obe-cel","n":127,"value":77}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2406526"},{"endpoint":"Complete remission","unit":"%","arms":[{"name":"Obe-cel","value":55}],"source":"https://doi.org/10.1001/jama.2024.28312"},{"endpoint":"Event-free survival (median)","unit":"months","arms":[{"name":"Obe-cel","value":11.9}],"source":"https://doi.org/10.1001/jama.2024.28312"}],"replication":"ALLCAR19 (the UCL phase 1 predecessor) showed the same low-toxicity, high-remission profile."},{"id":"nct02398773","kind":"trial","name":"FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy","aka":[],"tldr":"A phase 2 trial of Fluoroestradiol F-18 in Breast cancer, run by National Cancer Institute (NCI), active and no longer recruiting.","summary":"FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy is a phase 2 interventional study registered as NCT02398773 by National Cancer Institute (NCI), with 99 participants planned, started 2016-05-04 and due to reach its primary completion in 2026-12-31. Interventions recorded: Computed Tomography, F-18 16 Alpha-Fluoroestradiol, Laboratory Biomarker Analysis, Positron Emission Tomography. Conditions recorded: HER2/Neu Negative, Progesterone Receptor Negative, Progesterone Receptor Positive, Stage IV Breast Cancer AJCC v6 and v7.\n\nLinked to the drug Fluoroestradiol F-18 because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02398773","url":"https://clinicaltrials.gov/study/NCT02398773"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["fluoroestradiol-f18"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02398773","phase":"2","setting":"[18F] Fluoroestradiol (FES) PET as a Predictive Measure for Endocrine Therapy in Patients With Newly Diagnosed Metastatic Breast Cancer","sponsor":"National Cancer Institute (NCI)","started":"2016-05-04","startedType":"actual","enrolled":99,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06759857","kind":"trial","name":"FHND9041 Versus Afatinib for Non-small Cell Lung Cancer","aka":["FHND9041"],"tldr":"A phase 3 trial of afatinib in lung cancer, run by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., now recruiting.","summary":"FHND9041 Versus Afatinib for Non-small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT06759857 by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., with a registry enrolment figure of 350 participants, started 2021-08-01 and due to reach its primary completion in 2025-03-04. Interventions recorded: FHND9041; Afatinib. Conditions listed: Non Small Cell Lung Cancer. Primary outcome: Progression-Free Survival (PFS). Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC), including patients with recurrent disease following prior surgical treatment or newly diagnosed Stage IIIb, IIIc, or IV NSCLC (staging based on the 8th edition of the AJCC guid\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06759857","url":"https://clinicaltrials.gov/study/NCT06759857"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["afatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06759857","phase":"3","setting":"A Randomized, Open, Positives Parallel-controlled, Multicenter Phase III to Evaluate the Efficacy and Safety of FHND9041 Versus Afatinib in First-line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.","started":"2021-08-01","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"fianlimab-phase3-melanoma","kind":"trial","name":"Fianlimab + cemiplimab phase 3 (first-line melanoma)","aka":[],"tldr":"A second LAG-3 blocker failed to beat pembrolizumab alone, a warning that the Opdualag result is not automatically a class effect.","summary":"Regeneron reported that the trial missed its primary PFS endpoint; the high-dose combination improved median PFS numerically by 5.1 months, but the difference was not statistically significant. Differences from RELATIVITY-047 include the comparator (pembrolizumab rather than nivolumab), the antibody, and dosing. The adjuvant fianlimab phase 3 continues.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05352672","url":"https://clinicaltrials.gov/study/NCT05352672"},{"label":"Regeneron update","url":"https://investor.regeneron.com/news-releases/news-release-details/regeneron-provides-update-phase-3-trial-fianlimab-lag-3"}],"tags":["failure","lesson:class-effect-not-guaranteed"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["lag3","pd1"],"drugs":["fianlimab","cemiplimab","pembrolizumab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":["relativity-047"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05352672","phase":"3","setting":"Untreated unresectable or metastatic melanoma: fianlimab + cemiplimab (two dose levels) vs pembrolizumab","sponsor":"Regeneron","result":"Primary PFS endpoint not met; numerical +5.1 months median PFS at the high dose.","started":"2022-07-14","startedType":"actual","yearReported":2026,"enrolled":1546,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival, fianlimab 1600 mg + cemiplimab vs pembrolizumab","primary":true,"unit":"months","arms":[{"name":"Fianlimab 1600 mg + cemiplimab","n":508,"value":11.5,"note":"Not significant; primary endpoint not met"},{"name":"Pembrolizumab","n":462,"value":6.4}],"hr":0.845,"ci":[0.709,1.008],"p":"0.0627","source":"https://www.cancernetwork.com/view/fianlimab-combo-does-not-significantly-improve-pfs-in-advanced-melanoma"},{"endpoint":"Progression-free survival, fianlimab 400 mg + cemiplimab vs pembrolizumab","primary":true,"unit":"months","arms":[{"name":"Fianlimab 400 mg + cemiplimab","n":422,"value":9.6,"note":"Not significant"},{"name":"Pembrolizumab","n":462,"value":6.4}],"hr":0.931,"ci":[0.773,1.112],"p":"0.4661","source":"https://www.cancernetwork.com/view/fianlimab-combo-does-not-significantly-improve-pfs-in-advanced-melanoma"},{"endpoint":"Progression-free survival, cemiplimab monotherapy arm","unit":"months","arms":[{"name":"Cemiplimab","n":154,"value":6.3}],"source":"https://www.cancernetwork.com/view/fianlimab-combo-does-not-significantly-improve-pfs-in-advanced-melanoma"}],"replication":"Second LAG-3 setback after RELATIVITY-098; the numerical PFS gain at the high dose did not reproduce the phase 1 signal, and RELATIVITY-047 remains the only positive randomised LAG-3 trial in melanoma."},{"id":"nct06332092","kind":"trial","name":"FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma","aka":[],"tldr":"A phase 2 trial of FID007 in head and neck squamous cell carcinoma, run by Fulgent Pharma LLC., active and no longer recruiting.","summary":"FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma is a phase 2 interventional study registered as NCT06332092 by Fulgent Pharma LLC., with 46 participants enrolled, started 2024-04-10 and due to reach its primary completion in 2025-12-31. Interventions recorded: FID007.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06332092","url":"https://clinicaltrials.gov/study/NCT06332092"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06332092","phase":"2","setting":"A Phase 2, Randomized, Multicenter, Open-label, Study of FID-007 in Combination With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma","sponsor":"Fulgent Pharma LLC.","started":"2024-04-10","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"fight-202","kind":"trial","name":"FIGHT-202","aka":[],"tldr":"FIGHT-202 is the single-arm study that produced the first targeted approval in bile duct cancer.","summary":"FIGHT-202, trial NCT02924376 sponsored by Incyte and reported in 2020, is the single-arm phase 2 study that produced the first targeted approval in bile duct cancer, for pemigatinib in previously treated cholangiocarcinoma with FGFR2 fusions. Among 147 patients, the 107 with FGFR2 fusions in cohort A had an objective response rate of about 37 percent with durable disease control, while patients with other FGF or FGFR alterations had no responses. OnCo links it to biliary tract cancer, FGFR2 as a target and pemigatinib. Without a randomised comparison the trial cannot show a survival advantage, and the first-line confirmatory trial FIGHT-302 was discontinued, so where FGFR inhibition best fits in the sequence is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02924376","url":"https://clinicaltrials.gov/study/NCT02924376"}],"tags":[],"related":[],"cancers":["cholangiocarcinoma","intrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["fgfr2"],"drugs":["pemigatinib"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Gallbladder cancer: FIGHT-202 enrolled cholangiocarcinoma only, and the resulting licence (Pemazyre label) is for cholangiocarcinoma with an FGFR2 fusion or rearrangement; gallbladder cancer was not part of the trial or the approval population."],"nct":"NCT02924376","phase":"2","setting":"Previously treated cholangiocarcinoma with FGFR2 fusions (cohort A): pemigatinib single arm","sponsor":"Incyte","result":"ORR 37%; PFS 7.0 months; OS 17.5 months.","started":"2017-01-16","startedType":"actual","yearReported":2020,"enrolled":147,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Pemigatinib (FGFR2 fusion)","n":107,"value":35.5}],"source":"https://doi.org/10.1016/S1470-2045(20)30109-1"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Pemigatinib","value":7}],"source":"https://doi.org/10.1016/S1470-2045(20)30109-1"}]},{"id":"fight-302","kind":"trial","name":"FIGHT-302","aka":[],"tldr":"FIGHT-302 set out to test whether the FGFR2 inhibitor pemigatinib should be used before chemotherapy in bile duct cancers driven by an FGFR2 fusion; the trial closed early after the standard of care changed, and its 2026 report showed pemigatinib delayed progression compared with chemotherapy, with similar overall survival.","summary":"Pemigatinib was approved in 2020 for previously treated cholangiocarcinoma with an FGFR2 fusion or rearrangement on the single-arm FIGHT-202 study. FIGHT-302 was the confirmatory phase 3 trial, randomising patients with untreated, unresectable or metastatic FGFR2-rearranged cholangiocarcinoma to pemigatinib or to gemcitabine and cisplatin, with progression-free survival as the primary endpoint.\n\nThe trial closed early after a change in standard of care, having randomised 167 patients. The 2026 report in the Journal of Clinical Oncology showed median progression-free survival of 8.3 months with pemigatinib against 6.8 months with chemotherapy (hazard ratio 0.58), an objective response rate of 47 percent against 15 percent, and similar overall survival (24.4 against 25.0 months), so pemigatinib delays progression in the first line but the truncated trial could not show a survival advantage.","status":"withdrawn","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03656536","url":"https://clinicaltrials.gov/study/NCT03656536"}],"tags":["subtype-trials"],"related":[],"cancers":["cholangiocarcinoma","intrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["pemigatinib","gemcitabine-cisplatin"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["tanios-bekaii-saab"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registry status on 22 September 2026: Terminated (registry record last updated 11 August 2026; primary completion reached 7 July 2025). Why stopped, in the sponsor's words: The study was terminated due to lack of enrollment resulting from a change in the standard of care for the first-line treatment of patients with cholangiocarcinoma. There were no safety concerns that contributed to this decision."],"nct":"NCT03656536","phase":"3","setting":"Untreated advanced cholangiocarcinoma with an FGFR2 rearrangement: pemigatinib against gemcitabine and cisplatin","sponsor":"Incyte","started":"2019-06-03","startedType":"actual","yearReported":2026,"enrolled":167,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Pemigatinib","n":83,"value":8.3,"note":"Trial closed early after a change in standard of care; crossover to pemigatinib allowed"},{"name":"Gemcitabine + cisplatin","n":84,"value":6.8}],"hr":0.58,"ci":[0.39,0.87],"p":"0.0078 (nominal)","source":"https://doi.org/10.1200/jco-26-00788"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Pemigatinib","n":83,"value":47},{"name":"Gemcitabine + cisplatin","n":84,"value":15}],"source":"https://doi.org/10.1200/jco-26-00788"},{"endpoint":"Duration of response","unit":"months","arms":[{"name":"Pemigatinib","n":83,"value":14.2},{"name":"Gemcitabine + cisplatin","n":84,"value":6.3}],"source":"https://doi.org/10.1200/jco-26-00788"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Pemigatinib","n":83,"value":24.4},{"name":"Gemcitabine + cisplatin","n":84,"value":25}],"source":"https://doi.org/10.1200/jco-26-00788"}]},{"id":"nct06303505","kind":"trial","name":"FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC","aka":["NAPISTAR1-01"],"tldr":"A phase 1/2 trial of TUB-040 in ovarian cancer and non-small-cell lung cancer, run by Tubulis GmbH, now recruiting.","summary":"FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC is a phase 1/2 interventional study registered as NCT06303505 by Tubulis GmbH, with 250 participants planned, started 2024-06-12 and due to reach its primary completion in 2027-12. Interventions recorded: TUB-040.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06303505","url":"https://clinicaltrials.gov/study/NCT06303505"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","nsclc","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["tubulis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06303505","phase":"1/2","setting":"A Multicenter, First-in-human Dose Escalation and Optimization Phase I/IIa Study to Investigate Safety, Tolerability, PK, and Efficacy of the NaPi2b ADC TUB-040 in Patients With Platinum-resistant High-grade Ovarian Cancer (PROC) or r/r Adenocarcinoma Non-small Cell Lung Cancer (NSCLC)","sponsor":"Tubulis GmbH","started":"2024-06-12","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06669117","kind":"trial","name":"FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations","aka":[],"tldr":"A phase 1/2 trial of VERT-002 in advanced solid tumours, run by Pierre Fabre Medicament, now recruiting.","summary":"FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations is a phase 1/2 interventional study registered as NCT06669117 by Pierre Fabre Medicament, with 140 participants planned, started 2024-10-22 and due to reach its primary completion in 2030-10-21. Interventions recorded: VERT-002.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06669117","url":"https://clinicaltrials.gov/study/NCT06669117"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["met"],"drugs":[],"companies":["pierre-fabre"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06669117","phase":"1/2","setting":"A First-In-Human (FIH) Phase I/II Open-label, Multicentre, Dose Escalation and Expansion Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors Including Non-small Cell Lung Cancer (NSCLC) Harboring Mesenchymal-Epithelial Transition (MET) Alterations","sponsor":"Pierre Fabre Medicament","started":"2024-10-22","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06154291","kind":"trial","name":"FIH XON7 in Advanced/Metastatic Solid Tumors","aka":["FIPO23"],"tldr":"A phase 1/2 trial of XON7 in advanced solid tumours, run by Xenothera SAS, now recruiting.","summary":"FIH XON7 in Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06154291 by Xenothera SAS, with 255 participants planned, started 2023-11-14 and due to reach its primary completion in 2026-12. Interventions recorded: XON7.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06154291","url":"https://clinicaltrials.gov/study/NCT06154291"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06154291","phase":"1/2","setting":"Phase I/II, Multi Center, Open Label, First-in-human, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-tumors Efficacy of the Glyco-humanized Polyclonal Antibody XON7 in Patients With Advanced or Metastatic Solid Tumors","sponsor":"Xenothera SAS","started":"2023-11-14","startedType":"actual","enrolled":255,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01301963","kind":"trial","name":"Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide","aka":[],"tldr":"A phase 3 trial of Plerixafor and Filgrastim in Multiple myeloma, run by Case Comprehensive Cancer Center, recorded as terminated on the registry.","summary":"Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide is a phase 3 interventional study registered as NCT01301963 by Case Comprehensive Cancer Center, with 9 participants recorded, started 2011-07 and due to reach its primary completion in 2013-06. Interventions recorded: plerixafor, filgrastim. Conditions recorded: Refractory Multiple Myeloma.\n\nLinked to the drug Plerixafor because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01301963","url":"https://clinicaltrials.gov/study/NCT01301963"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["plerixafor","filgrastim"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01301963","phase":"3","setting":"Comparison of Plerixafor and G-CSF Versus G-CSF Alone for Stem Cell Mobilization in Patients With Multiple Myeloma Previously Treated With Lenalidomide","sponsor":"Case Comprehensive Cancer Center","started":"2011-07","enrolled":9,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02497820","kind":"trial","name":"Finding the Best Dose of Aspirin to Prevent Lynch Syndrome Cancers","aka":["CaPP3 Israel"],"tldr":"A phase 3 trial of aspirin in colorectal cancer, run by Tel-Aviv Sourasky Medical Center, not yet recruiting.","summary":"Finding the Best Dose of Aspirin to Prevent Lynch Syndrome Cancers is a phase 3, randomised interventional study registered as NCT02497820 by Tel-Aviv Sourasky Medical Center, with a registry enrolment figure of 1800 participants, started 2016-09 and due to reach its primary completion in 2027-09. Interventions recorded: Aspirin. Conditions listed: Lynch Syndrome I (Site-specific Colonic Cancer). Primary outcome: cancer preventive properties of enteric coated aspirin in Lynch syndrome are dose sensitive by comparing overall cumulative Lynch syndrome cancer. Sites: Israel. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02497820","url":"https://clinicaltrials.gov/study/NCT02497820"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["aspirin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02497820","phase":"3","setting":"A Randomised Double Blind Dose Non-inferiority Trial of a Daily Dose of 600mg Versus 300mg Versus 100mg of Enteric Coated Aspirin as a Cancer Preventive in Carriers of a Germline Pathological Mismatch Repair Gene Defect, Lynch Syndrome","sponsor":"Tel-Aviv Sourasky Medical Center","started":"2016-09","enrolled":1800,"enrolledBasis":"registry","outcomes":[]},{"id":"firefly-1","kind":"trial","name":"FIREFLY-1","aka":[],"tldr":"FIREFLY-1 showed that a once-weekly pill, tovorafenib, shrinks most relapsed childhood low-grade gliomas driven by BRAF changes, including the common KIAA1549-BRAF fusion that older BRAF drugs could not treat safely. It led to the first approval of a drug for this disease.","summary":"Open-label phase 2 of tovorafenib, an oral type II RAF inhibitor that does not cause the paradoxical MAPK activation seen with type I BRAF inhibitors in BRAF-fusion tumours. In the registrational arm 1 (n = 77), independent review found an overall response rate of 67% by RANO-HGG criteria (the prespecified primary endpoint) and 51% by RAPNO-LGG criteria including minor responses; median duration of response 16.6 months and median time to response 3.0 months. Treatment-related adverse events led to discontinuation in 7% of patients; hair colour change, elevated creatine phosphokinase, anaemia and slowed growth velocity were characteristic. FDA accelerated approval followed on 23 April 2024 for relapsed or refractory paediatric LGG with BRAF fusion or rearrangement or BRAF V600 mutation. The confirmatory phase 3 LOGGIC/FIREFLY-2 trial compares tovorafenib with chemotherapy in the front line.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT04775485","url":"https://clinicaltrials.gov/study/NCT04775485"},{"label":"Kilburn et al., Nature Medicine 2024","url":"https://doi.org/10.1038/s41591-023-02668-y"}],"tags":["nci-coverage","paediatric","cns"],"related":[],"cancers":["paediatric-low-grade-glioma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["braf"],"drugs":["tovorafenib"],"companies":["day-one-biopharmaceuticals"],"institutions":[],"pathways":["ras-mapk"],"terms":["race-for-children-act"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-kilburn-nat-med"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04775485","phase":"2","setting":"Relapsed or refractory BRAF-altered paediatric low-grade glioma: single-arm tovorafenib (arm 1, n = 77 registrational cohort)","sponsor":"Day One Biopharmaceuticals","result":"ORR 67% (RANO-HGG) and 51% (RAPNO-LGG) in arm 1; median DOR 16.6 months.","started":"2021-04-22","startedType":"actual","yearReported":2023,"enrolled":141,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate (RANO-HGG, independent review)","primary":true,"unit":"%","arms":[{"name":"Tovorafenib (arm 1)","n":77,"value":67}],"source":"https://doi.org/10.1038/s41591-023-02668-y"},{"endpoint":"Overall response rate (RAPNO-LGG, including minor responses)","unit":"%","arms":[{"name":"Tovorafenib (arm 1)","n":77,"value":51}],"source":"https://doi.org/10.1038/s41591-023-02668-y"},{"endpoint":"Median duration of response","unit":"months","arms":[{"name":"Tovorafenib (arm 1)","value":16.6}],"source":"https://doi.org/10.1038/s41591-023-02668-y"}],"replication":"Single-arm registrational study; confirmatory randomised phase 3 (LOGGIC/FIREFLY-2, NCT05566795) in newly diagnosed RAF-altered LGG is ongoing."},{"id":"fires-sentor","kind":"trial","name":"FIRES & SENTOR (sentinel node mapping)","aka":[],"tldr":"Mapping and removing only the first draining lymph nodes finds spread as reliably as removing all of them, with far less lymphoedema.","summary":"FIRES and SENTOR, led by trial NCT01673022 and run academically at Indiana University and the University of Toronto, showed that mapping and removing only the first draining lymph nodes with indocyanine green finds spread in endometrial cancer as reliably as removing all of them, with far less lymphoedema. FIRES, published in Lancet Oncology in 2017 with 385 patients, reported sensitivity of 97.2 percent and a negative predictive value of 99.6 percent, and SENTOR, published in JAMA Surgery in 2021 with 156 high-grade patients, reported sensitivity of 96 percent and a negative predictive value of 99 percent. Sentinel node biopsy is now standard in apparent early-stage disease under NCCN and ESGO guidance, and whether it changes survival rather than only staging is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01673022","url":"https://clinicaltrials.gov/study/NCT01673022"},{"label":"FIRES, Lancet Oncology 2017","url":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30068-2/fulltext"}],"tags":[],"related":[],"cancers":["endometrial"],"sections":[],"technologies":["sentinel-node","optical-imaging","robotic-surgery"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01673022","phase":"observational","setting":"Endometrial cancer staging: indocyanine-green sentinel lymph node mapping compared against full lymphadenectomy","sponsor":"Academic (Indiana University; University of Toronto)","result":"Sensitivity 97%, NPV 99.6% (FIRES).","started":"2012-05","yearReported":2017,"enrolledBasis":"registry","outcomes":[{"endpoint":"FIRES: sensitivity of sentinel-node mapping for nodal metastasis","primary":true,"unit":"%","arms":[{"name":"ICG sentinel-node mapping vs complete lymphadenectomy","n":340,"value":97.2,"note":"95% CI 85.0-100; 385 enrolled, 340 analysed; negative predictive value 99.6% (95% CI 97.9-100)"}],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30068-2/fulltext"},{"endpoint":"SENTOR: sensitivity of the sentinel-node algorithm in intermediate/high-grade endometrial cancer","primary":true,"unit":"%","arms":[{"name":"ICG sentinel-node biopsy vs lymphadenectomy","n":156,"value":96,"note":"95% CI 81-100; negative predictive value 99% (95% CI 96-100); false-negative rate 4%"}],"source":"https://doi.org/10.1001/jamasurg.2020.5060"}],"replication":"Two independent prospective cohorts (USA and Canada) with matching accuracy, the latter in high-grade histologies; supported by the SHREC and Italian multicentre series and now standard in NCCN/ESGO guidance."},{"id":"nct06956001","kind":"trial","name":"Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation","aka":[],"tldr":"A phase 3 trial of Pemetrexed, Cisplatin, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Allist Pharmaceuticals, Inc., now recruiting.","summary":"Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation is a phase 3 interventional study registered as NCT06956001 by Allist Pharmaceuticals, Inc., with 300 participants planned, started 2024-11-19 and due to reach its primary completion in 2027-12. Interventions recorded: Firmonertinib Mesilate Tablets, Pemetrexed Disodium for Injection, Cisplatin for injection, Carboplatin Injection. Conditions listed: EGFR, NSCLC (Advanced Non-small Cell Lung Cancer). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06956001","url":"https://clinicaltrials.gov/study/NCT06956001"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pemetrexed","cisplatin","carboplatin"],"companies":["allist"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06956001","phase":"3","setting":"A Phase III, Randomized, Multicentre, Open Label Study to Assess the Efficacy and Safety of Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients With EGFR PACC Mutation or EGFR l861q Mutation","sponsor":"Allist Pharmaceuticals, Inc.","started":"2024-11-19","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05141149","kind":"trial","name":"First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of Gemcitabine in pancreatic ductal adenocarcinoma, run by Prestige Biopharma Limited, active and no longer recruiting.","summary":"First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer is a phase 1/2 interventional study registered as NCT05141149 by Prestige Biopharma Limited, with 80 participants enrolled, started 2023-06-05 and due to reach its primary completion in 2026-07. Interventions recorded: PBP1510 (400mg/16mL) and Gemcitabine (1000 mg/m^2).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05141149","url":"https://clinicaltrials.gov/study/NCT05141149"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["gemcitabine","pbp1510"],"companies":["prestige-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05141149","phase":"1/2","setting":"A First in Human, Phase 1/2a, Multicentre, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of PBP1510 in Patients With Advanced/Metastatic Pancreatic Cancer","sponsor":"Prestige Biopharma Limited","started":"2023-06-05","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05647122","kind":"trial","name":"First in Human Study of AZD9592 in Solid Tumors","aka":[],"tldr":"A phase 1 trial of Tilatamig samrotecan, Osimertinib, Fluorouracil and Leucovorin in Head and neck squamous cell carcinoma, run by AstraZeneca, active and no longer recruiting.","summary":"First in Human Study of AZD9592 in Solid Tumors is a phase 1 interventional study registered as NCT05647122 by AstraZeneca, with 167 participants planned, started 2022-12-21 and due to reach its primary completion in 2028-08-03. Interventions recorded: AZD9592, Osimertinib, 5-Fluorouracil (5-FU), Leucovorin, Bevacizumab. Conditions recorded: Advanced Solid Tumours, Carcinoma Non-small Cell Lung, Head and Neck Neoplasms, Colorectal Neoplasms.\n\nLinked to the drug Tilatamig samrotecan because the registry names it among its interventions and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05647122","url":"https://clinicaltrials.gov/study/NCT05647122"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":["tilatamig-samrotecan","osimertinib","fluorouracil","leucovorin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05647122","phase":"1","setting":"A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumors","sponsor":"AstraZeneca","started":"2022-12-21","startedType":"actual","enrolled":167,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05120596","kind":"trial","name":"First in Human Study of T3P-Y058-739 (T3P)","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by T3 Pharmaceuticals AG, now recruiting.","summary":"First in Human Study of T3P-Y058-739 (T3P) is a phase 1/2 interventional study registered as NCT05120596 by T3 Pharmaceuticals AG, with 100 participants planned, started 2022-04-26 and due to reach its primary completion in 2027-02-28. Interventions recorded: Pembrolizumab+T3P-Y058-739, T3P-Y058-739 (IV) and T3P-Y058-739 (IT).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05120596","url":"https://clinicaltrials.gov/study/NCT05120596"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05120596","phase":"1/2","setting":"An Open-label, Phase I/II Study of T3P-Y058-739, a Genetically-modified Strain of the Bacterium Yersinia Enterocolitica, in Patients With Advanced Solid Tumours","sponsor":"T3 Pharmaceuticals AG","started":"2022-04-26","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06657222","kind":"trial","name":"First in Human Study of TUB-030 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of TUB-030 in small-cell lung cancer, non-small-cell lung cancer and triple-negative breast cancer, run by Tubulis GmbH, now recruiting.","summary":"First in Human Study of TUB-030 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06657222 by Tubulis GmbH, with 250 participants planned, started 2024-12-13 and due to reach its primary completion in 2028-12. Interventions recorded: TUB-030.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06657222","url":"https://clinicaltrials.gov/study/NCT06657222"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","nsclc","tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["tubulis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06657222","phase":"1/2","setting":"A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)","sponsor":"Tubulis GmbH","started":"2024-12-13","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06795022","kind":"trial","name":"First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours","aka":["RHEA-1"],"tldr":"A phase 1/2 trial of AZD9793 in hepatocellular carcinoma, run by AstraZeneca, now recruiting.","summary":"First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours is a phase 1/2 interventional study registered as NCT06795022 by AstraZeneca, with 304 participants planned, started 2025-03-27 and due to reach its primary completion in 2027-06-30. Interventions recorded: AZD9793 Intravenous (IV) monotherapy and AZD9793 Subcutaneous (SC) monotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06795022","url":"https://clinicaltrials.gov/study/NCT06795022"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":[],"targets":[],"drugs":["azd9793"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06795022","phase":"1/2","setting":"A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD9793, a T Cell-engaging Antibody Targeting Glypican-3 (GPC3) in Adult Participants With Advanced or Metastatic Solid Tumours (RHEA-1)","sponsor":"AstraZeneca","started":"2025-03-27","startedType":"actual","enrolled":304,"enrolledBasis":"registry","outcomes":[]},{"id":"first-308","kind":"trial","name":"FIRST-308","aka":[],"tldr":"The first phase 3 trial for patients whose bile duct cancer has outgrown the existing FGFR drugs.","summary":"FIRST-308, sponsored by TransThera, is the first phase 3 trial for patients whose bile duct cancer has outgrown the existing FGFR drugs, testing tinengotinib against FOLFOX or FOLFIRI chemotherapy in FGFR-altered cholangiocarcinoma refractory to chemotherapy and a first-generation FGFR inhibitor. It is a global randomised trial with progression-free survival as the primary endpoint, and the first US patient was dosed in 2025. OnCo links it to biliary tract cancer, FGFR2 as a target and tinengotinib. Whether a next-generation inhibitor active against kinase-domain resistance mutations can beat chemotherapy in patients who have already progressed on targeted therapy is the question it exists to answer.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"TransThera announcement","url":"https://www.biospace.com/transthera-announces-the-global-multicenter-phase-3-clinical-trial-completed-first-patient-dosing-in-the-us-evaluating-tinengotinib-in-fgfri-relapsed-refractory-patients-with-cholangiocarcinoma"}],"tags":[],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["fgfr2"],"drugs":["tinengotinib"],"companies":["transthera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"FGFR-altered cholangiocarcinoma refractory to chemotherapy and a first-generation FGFR inhibitor: tinengotinib vs FOLFOX/FOLFIRI","sponsor":"TransThera","enrolledBasis":"registry","outcomes":[]},{"id":"nct06877650","kind":"trial","name":"First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab and Ivonescimab in advanced solid tumours, run by Shanghai JMT-Bio Inc., now recruiting.","summary":"First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors is a phase 1/2 interventional study registered as NCT06877650 by Shanghai JMT-Bio Inc., with 436 participants planned, started 2025-04-11 and due to reach its primary completion in 2028-03-30. Interventions recorded: JMT108, Pembrolizumab and Ivonescimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06877650","url":"https://clinicaltrials.gov/study/NCT06877650"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","ivonescimab"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06877650","phase":"1/2","setting":"A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors.","sponsor":"Shanghai JMT-Bio Inc.","started":"2025-04-11","startedType":"actual","enrolled":436,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05601726","kind":"trial","name":"First-in-human Study Aiming to Characterize the Safety, Tolerability, Pharmacokinetic and Preliminary Signs of Activity of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients","aka":["ODYSSEY"],"tldr":"A phase 1/2 trial of ABD-3001 in acute myeloid leukaemia and myelodysplastic syndromes / neoplasms, run by Advanced BioDesign, now recruiting.","summary":"First-in-human Study Aiming to Characterize the Safety, Tolerability, Pharmacokinetic and Preliminary Signs of Activity of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients is a phase 1/2 interventional study registered as NCT05601726 by Advanced BioDesign, with 36 participants planned, started 2022-11-08 and due to reach its primary completion in 2026-06. Interventions recorded: ABD-3001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05601726","url":"https://clinicaltrials.gov/study/NCT05601726"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","mds","aml-older-unfit","mds-higher-risk"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05601726","phase":"1/2","setting":"First-In-Human, Open Label, Dose Escalation Study to Evaluate Safety, PK and PD of ABD-3001 As Monotherapy in Relapsed/Refractory Acute Myeloid Leukemia or High/Very-high Risk Myelodysplastic Syndromes Patients, Ineligible for Intensive or New Generation Targeted Therapy.","sponsor":"Advanced BioDesign","started":"2022-11-08","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07216560","kind":"trial","name":"First-in-human Study of 7MW4911 in GI Cancer","aka":[],"tldr":"A phase 1/2 trial of 7MW4911 in advanced solid tumours, run by Mabwell (Shanghai) Bioscience Co., Ltd., now recruiting.","summary":"First-in-human Study of 7MW4911 in GI Cancer is a phase 1/2 interventional study registered as NCT07216560 by Mabwell (Shanghai) Bioscience Co., Ltd., with 200 participants planned, started 2026-01-13 and due to reach its primary completion in 2027-07. Interventions recorded: 7MW4911.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07216560","url":"https://clinicaltrials.gov/study/NCT07216560"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["mabwell-shanghai-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07216560","phase":"1/2","setting":"A Phase I/II Study of 7MW4911 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With Advanced Colorectal Cancer and Other Advanced Gastrointestinal Tumors","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","started":"2026-01-13","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07265622","kind":"trial","name":"First-in-human Study of 7MW4911 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of 7MW4911 in advanced solid tumours, run by Mabwell (Shanghai) Bioscience Co., Ltd., now recruiting.","summary":"First-in-human Study of 7MW4911 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07265622 by Mabwell (Shanghai) Bioscience Co., Ltd., with 200 participants planned, started 2025-11-12 and due to reach its primary completion in 2027-07. Interventions recorded: 7MW4911.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07265622","url":"https://clinicaltrials.gov/study/NCT07265622"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["mabwell-shanghai-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07265622","phase":"1/2","setting":"A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of 7MW4911 in Patients With Advanced Solid Tumors","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","started":"2025-11-12","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06797999","kind":"trial","name":"First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma","aka":["ADCElerate1"],"tldr":"A phase 1/2 trial of Antibody-drug conjugate (ADC) in sarcomas, run by Adcendo ApS, now recruiting.","summary":"First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma is a phase 1/2 interventional study registered as NCT06797999 by Adcendo ApS, with 270 participants planned, started 2025-06-05 and due to reach its primary completion in 2029-02-27. Interventions recorded: Antibody-drug conjugate (ADC).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06797999","url":"https://clinicaltrials.gov/study/NCT06797999"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":["adc"],"targets":["top1"],"drugs":[],"companies":["adcendo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06797999","phase":"1/2","setting":"A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of ADCE-D01, a Humanized Anti-human uPARAP Antibody Linked to a Topoisomerase I Inhibitor, in Patients With Metastatic and/or Unresectable Soft Tissue Sarcoma","sponsor":"Adcendo ApS","started":"2025-06-05","startedType":"actual","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05920135","kind":"trial","name":"First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI","aka":[],"tldr":"A phase 1/2 trial of BBT-207 in non-small-cell lung cancer, run by Bridge Biotherapeutics, Inc., active and no longer recruiting.","summary":"First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI is a phase 1/2 interventional study registered as NCT05920135 by Bridge Biotherapeutics, Inc., with 24 participants enrolled, started 2023-09-11 and due to reach its primary completion in 2026-08-01. Interventions recorded: BBT-207.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05920135","url":"https://clinicaltrials.gov/study/NCT05920135"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":["egfr"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05920135","phase":"1/2","setting":"First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI","sponsor":"Bridge Biotherapeutics, Inc.","started":"2023-09-11","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06603844","kind":"trial","name":"First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.","aka":[],"tldr":"A phase 1/2 trial of CRB-601 monoclonal antibody in advanced solid tumours, run by Corbus Pharmaceuticals Inc., now recruiting.","summary":"First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor. is a phase 1/2 interventional study registered as NCT06603844 by Corbus Pharmaceuticals Inc., with 156 participants planned, started 2024-12-04 and due to reach its primary completion in 2026-11-01. Interventions recorded: CRB-601 monoclonal antibody and Anti-PD-1 monoclonal antibody.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06603844","url":"https://clinicaltrials.gov/study/NCT06603844"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["corbus-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06603844","phase":"1/2","setting":"A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of CRB-601, a Monoclonal Antibody Against Integrin avb8, in Patients With Advanced Solid Tumors","sponsor":"Corbus Pharmaceuticals Inc.","started":"2024-12-04","startedType":"actual","enrolled":156,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05438329","kind":"trial","name":"First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab and PM8002 in advanced solid tumours, run by DualityBio Inc., active and no longer recruiting.","summary":"First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05438329 by DualityBio Inc., with 1123 participants enrolled, started 2022-07-19 and due to reach its primary completion in 2027-08-13. Interventions recorded: DB-1305/BNT325, Pembrolizumab and BNT327.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05438329","url":"https://clinicaltrials.gov/study/NCT05438329"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","pm8002"],"companies":["dualitybio","biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05438329","phase":"1/2","setting":"A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1305 in Subjects With Advanced/Metastatic Solid Tumors","sponsor":"DualityBio Inc.","started":"2022-07-19","startedType":"actual","enrolled":1123,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06554795","kind":"trial","name":"First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of DB-1419 in advanced solid tumours, run by DualityBio Inc., now recruiting.","summary":"First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06554795 by DualityBio Inc., with 360 participants planned, started 2024-09-03 and due to reach its primary completion in 2027-02. Interventions recorded: DB-1419.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06554795","url":"https://clinicaltrials.gov/study/NCT06554795"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["dualitybio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06554795","phase":"1/2","setting":"A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants With Advanced/Metastatic Solid Tumors","sponsor":"DualityBio Inc.","started":"2024-09-03","startedType":"actual","enrolled":360,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05875168","kind":"trial","name":"First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of DS-3939a in advanced solid tumours, run by Daiichi Sankyo, now recruiting.","summary":"First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05875168 by Daiichi Sankyo, with 590 participants planned, started 2023-08-18 and due to reach its primary completion in 2026-10-20. Interventions recorded: DS-3939a.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05875168","url":"https://clinicaltrials.gov/study/NCT05875168"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05875168","phase":"1/2","setting":"Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors","sponsor":"Daiichi Sankyo","started":"2023-08-18","startedType":"actual","enrolled":590,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04243499","kind":"trial","name":"First-in-Human Study of ICT01 in Patients With Advanced Cancer","aka":["EVICTION"],"tldr":"A phase 1/2 trial of IV ICT01 in advanced solid tumours, run by ImCheck Therapeutics, an Ipsen company, active and no longer recruiting.","summary":"First-in-Human Study of ICT01 in Patients With Advanced Cancer is a phase 1/2 interventional study registered as NCT04243499 by ImCheck Therapeutics, an Ipsen company, with 293 participants enrolled, started 2020-03-05 and due to reach its primary completion in 2027-10-15. Interventions recorded: IV ICT01.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04243499","url":"https://clinicaltrials.gov/study/NCT04243499"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04243499","phase":"1/2","setting":"A First-in-human, Two-part Clinical Study to Assess the Safety, Tolerability and Activity of IV Doses of ICT01 as Monotherapy and in Combination With a Checkpoint Inhibitor, in Patients With Advanced-stage, Relapsed/Refractory Cancer","sponsor":"ImCheck Therapeutics, an Ipsen company","started":"2020-03-05","startedType":"actual","enrolled":293,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06043817","kind":"trial","name":"First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations","aka":[],"tldr":"A phase 1/2 trial of STX-721/PFL-721 (Escalated) in non-small-cell lung cancer, run by Pierre Fabre Medicament, now recruiting.","summary":"First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations is a phase 1/2 interventional study registered as NCT06043817 by Pierre Fabre Medicament, with 345 participants planned, started 2023-09-26 and due to reach its primary completion in 2029-12-01. Interventions recorded: STX-721/PFL-721 (Escalated), STX-721/PFL-721 (3 dose levels) and STX-721/PFL-721 (RP2D).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06043817","url":"https://clinicaltrials.gov/study/NCT06043817"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc","her2-mutant-nsclc"],"sections":[],"technologies":[],"targets":["her2","egfr"],"drugs":[],"companies":["pierre-fabre"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06043817","phase":"1/2","setting":"First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations","sponsor":"Pierre Fabre Medicament","started":"2023-09-26","startedType":"actual","enrolled":345,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05768139","kind":"trial","name":"First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors","aka":["PIKALO-1"],"tldr":"A phase 1/2 trial of Fulvestrant, Ribociclib, Palbociclib, Exemestane, Tamoxifen and Abemaciclib in advanced solid tumours, run by Eli Lilly and Company, now recruiting.","summary":"First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05768139 by Eli Lilly and Company, with 880 participants planned, started 2023-04-17 and due to reach its primary completion in 2030-07. Interventions recorded: STX-478, Fulvestrant, Ribociclib, Palbociclib, Letrozole and Anastrozole.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05768139","url":"https://clinicaltrials.gov/study/NCT05768139"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["fulvestrant","ribociclib","palbociclib","exemestane","tamoxifen","abemaciclib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05768139","phase":"1/2","setting":"First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors","sponsor":"Eli Lilly and Company","started":"2023-04-17","startedType":"actual","enrolled":880,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04725474","kind":"trial","name":"First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER)","aka":["GDFATHER"],"tldr":"A phase 1/2 trial of Visugromab and Nivolumab in advanced solid tumours, run by CatalYm GmbH, active and no longer recruiting.","summary":"First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER) is a phase 1/2 interventional study registered as NCT04725474 by CatalYm GmbH, with 199 participants enrolled, started 2020-12-09 and due to reach its primary completion in 2028-04-30. Interventions recorded: visugromab (CTL-002) and nivolumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04725474","url":"https://clinicaltrials.gov/study/NCT04725474"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["visugromab","nivolumab"],"companies":["catalym"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04725474","phase":"1/2","setting":"A Phase 1/2, FIH, Two-part, Open-label Clinical Trial of Intravenous (IV) Administration of CTL-002 Given as Monotherapy and/or in Combination With an Anti-PD-1 Checkpoint Inhibitor in Subjects With Advanced-stage, Relapsed/Refractory Solid Tumors (The \"GDFATHER\"-Trial: GDF-15 Antibody-mediaTed Human Effector Cell Relocation).","sponsor":"CatalYm GmbH","started":"2020-12-09","startedType":"actual","enrolled":199,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03319628","kind":"trial","name":"First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b","aka":[],"tldr":"A phase 1/2 trial of upifitamab rilsodotin in ovarian cancer and non-small-cell lung cancer, run by Mersana Therapeutics, active and no longer recruiting.","summary":"First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b is a phase 1/2 interventional study registered as NCT03319628 by Mersana Therapeutics, with 523 participants enrolled, started 2017-12-12 and due to reach its primary completion in 2023-05-31. Interventions recorded: upifitamab rilsodotin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03319628","url":"https://clinicaltrials.gov/study/NCT03319628"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["upifitamab-rilsodotin"],"companies":["mersana"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03319628","phase":"1/2","setting":"A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients With Solid Tumors Likely to Express NaPi2b","sponsor":"Mersana Therapeutics","started":"2017-12-12","startedType":"actual","enrolled":523,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07529717","kind":"trial","name":"First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer","aka":["CRIUS-1"],"tldr":"A phase 1/2 trial of AZD8359 in prostate cancer, run by AstraZeneca, now recruiting.","summary":"First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer is a phase 1/2 interventional study registered as NCT07529717 by AstraZeneca, with 42 participants planned, started 2026-05-18 and due to reach its primary completion in 2027-11-17. Interventions recorded: AZD8359.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07529717","url":"https://clinicaltrials.gov/study/NCT07529717"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07529717","phase":"1/2","setting":"Phase I/II Dose Escalation & Dose Optimization Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD8359, a CD8-guided T Cell-engaging Antibody That Targets STEAP2, in Adult Participants With Prostate Cancer","sponsor":"AstraZeneca","started":"2026-05-18","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06622486","kind":"trial","name":"First-in-human Trial of EGL-001 in Patients with Selected Advanced And/or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of EGL-001 in advanced solid tumours, run by Egle Therapeutics, now recruiting.","summary":"First-in-human Trial of EGL-001 in Patients with Selected Advanced And/or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06622486 by Egle Therapeutics, with 50 participants planned, started 2024-09-27 and due to reach its primary completion in 2027-01-23. Interventions recorded: EGL-001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06622486","url":"https://clinicaltrials.gov/study/NCT06622486"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06622486","phase":"1/2","setting":"First-in-human Phase 1/2 Trial of EGL-001 in Adult Patients with Selected Advanced And/or Metastatic Solid Tumors","sponsor":"Egle Therapeutics","started":"2024-09-27","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06934538","kind":"trial","name":"First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of STC-1010 + IS regimen + SOC therapy in colorectal cancer, run by Brenus Pharma, now recruiting.","summary":"First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer is a phase 1/2 interventional study registered as NCT06934538 by Brenus Pharma, with 90 participants planned, started 2025-06-17 and due to reach its primary completion in 2028-06. Interventions recorded: STC-1010 + IS regimen + SOC therapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06934538","url":"https://clinicaltrials.gov/study/NCT06934538"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06934538","phase":"1/2","setting":"Open Label, Multicenter, Dose-escalation and Cohort-expansion Phase I/IIA Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer (CRC) - BreAK CRC Trial (BreAK for Brenus Anti-cancer)","sponsor":"Brenus Pharma","started":"2025-06-17","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07136779","kind":"trial","name":"First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies","aka":[],"tldr":"A phase 1/2 trial of VBC101 in advanced solid tumours, run by VelaVigo Bio Inc, now recruiting.","summary":"First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies is a phase 1/2 interventional study registered as NCT07136779 by VelaVigo Bio Inc, with 310 participants planned, started 2025-09-23 and due to reach its primary completion in 2027-07-01. Interventions recorded: VBC101.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07136779","url":"https://clinicaltrials.gov/study/NCT07136779"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["egfr"],"drugs":[],"companies":["velavigo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07136779","phase":"1/2","setting":"PHASE 1/2A OPEN-LABEL CLINICAL TRIAL EVALUATING VBC101, AN EGFR AND CMET TARGETED BI-SPECIFIC ANTIBODY DRUG CONJUGATE, IN PARTICIPANTS WITH ADVANCED SOLID TUMOR MALIGNANCIES","sponsor":"VelaVigo Bio Inc","started":"2025-09-23","startedType":"actual","enrolled":310,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07700160","kind":"trial","name":"First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of VBC108 in advanced solid tumours, run by VelaVigo Bio Inc, now recruiting.","summary":"First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors is a phase 1/2 interventional study registered as NCT07700160 by VelaVigo Bio Inc, with 230 participants planned, started 2026-07-30 and due to reach its primary completion in 2029-07-07. Interventions recorded: VBC108.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07700160","url":"https://clinicaltrials.gov/study/NCT07700160"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["velavigo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07700160","phase":"1/2","setting":"Phase 1/2a Open-label Clinical Trial Evaluating VBC108, a CLDN18.2 and CDH17-directed Bi-specific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors","sponsor":"VelaVigo Bio Inc","started":"2026-07-30","startedType":"actual","enrolled":230,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06840782","kind":"trial","name":"First-line Immunotherapy-based Standard of Care and Local Ablative Treatments for Oligometastatic Non-small Cell Lung Cancer Patients.","aka":["OliGRAIL"],"tldr":"A phase 3 trial in lung cancer, run by Gustave Roussy, Cancer Campus, Grand Paris, now recruiting.","summary":"First-line Immunotherapy-based Standard of Care and Local Ablative Treatments for Oligometastatic Non-small Cell Lung Cancer Patients. is a phase 3, randomised interventional study registered as NCT06840782 by Gustave Roussy, Cancer Campus, Grand Paris, with a registry enrolment figure of 124 participants, started 2025-09-09 and due to reach its primary completion in 2030-02. Interventions recorded: Radical local treatment; SoC-based immunotherapy (+/- chemotherapy). Conditions listed: Oligometastatic Non-small Cell Lung Cancer (NSCLC). Primary outcome: Overall Survival (OS).. Lung eligibility wording from the registry: \"* Histologically proven advanced synchronous oligometastatic stage IV NSCLC\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06840782","url":"https://clinicaltrials.gov/study/NCT06840782"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06840782","phase":"3","setting":"First-line Immunotherapy-based Standard of Care and Local Ablative Treatments for Oligometastatic Non-small Cell Lung Cancer Patients: a Randomized, Multicentre, Open-label Phase III Study","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","started":"2025-09-09","startedType":"actual","enrolled":124,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07355205","kind":"trial","name":"First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer","aka":["FLINN"],"tldr":"A phase 1/2 trial of ipilimumab, nivolumab and nogapendekin alfa inbakicept in lung cancer, run by Washington University School of Medicine, now recruiting.","summary":"First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer is a phase 1/2, interventional study registered as NCT07355205 by Washington University School of Medicine, with a registry enrolment figure of 26 participants, started 2026-07-07 and due to reach its primary completion in 2032-07-31. Interventions recorded: Ipilimumab; Nivolumab; Nogapendekin alfa inbakicept. Conditions listed: Non-small Cell Lung Cancer Stage IV; Non-small Cell Lung Cancer Recurrent. Primary outcome: Progression-free survival (PFS) (Phase Ib acceptable dose participants and Phase II participants); Incidence of dose-limiting toxicities (DLTs) (Phase Ib participants). Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed, previously untreated or recurrent metastatic NSCLC\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07355205","url":"https://clinicaltrials.gov/study/NCT07355205"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ipilimumab","nivolumab","nogapendekin-alfa"],"companies":["immunitybio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07355205","phase":"1/2","setting":"A Phase Ib/II, Single-Center, Open-Label Study of First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (FLINN)","sponsor":"Washington University School of Medicine","started":"2026-07-07","startedType":"actual","enrolled":26,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07299409","kind":"trial","name":"First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.","aka":[],"tldr":"A phase 2 trial of sacituzumab govitecan in triple-negative breast cancer, run by Nathalie Levasseur, not yet recruiting.","summary":"First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients. is a phase 2, interventional study registered as NCT07299409 by Nathalie Levasseur, with a registry enrolment figure of 24 participants, started 2025-12 and due to reach its primary completion in 2027-08. Interventions recorded: Sacituzumab Govitecan (SG). Conditions listed: Advanced Triple Negative Breast Cancer; Breast Cancer Metastatic; Breast Cancer. Triple-negative eligibility wording from the registry: \"Advanced (locoregionally recurrent and non-operable, or metastatic) triple-negative breast cancer patients not amenable to curative therapy (surgery and/or radiotherapy), including those who are PDL1 negative (combined positive score \\[cps\\] \\<10), immuno-oncology therapy ineligible, or who had earl\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07299409","url":"https://clinicaltrials.gov/study/NCT07299409"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07299409","phase":"2","setting":"A Phase II Study of First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.","sponsor":"Nathalie Levasseur","started":"2025-12","startedType":"estimated","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05749900","kind":"trial","name":"First-line Trastuzumab, Gemcitabine, Cisplatin and Nivolumab in Advanced HER2- Positive Biliary Tract Cancer: a Multicenter, Open-label, Single-arm Phase Ib/II Trial (HERBOT)","aka":["HERBOT"],"tldr":"A phase 1/2 trial of trastuzumab, nivolumab, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by Yonsei University, now recruiting.","summary":"First-line Trastuzumab, Gemcitabine, Cisplatin and Nivolumab in Advanced HER2- Positive Biliary Tract Cancer: a Multicenter, Open-label, Single-arm Phase Ib/II Trial (HERBOT) is a phase 1/2 interventional study registered as NCT05749900 by Yonsei University, with a registry enrolment figure of 44 participants, started 2023-05-12 and due to reach its primary completion in 2026-02-28. Interventions recorded: Trastuzumab+Nivolumab+Gemcitabine+Cisplatin. Conditions listed: HER2 Positive Advanced/Metastatic/Nonresectable Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: \"1. Subjects with histologically- or cytologically-confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancer)\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05749900","url":"https://clinicaltrials.gov/study/NCT05749900"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["monoclonal-antibody","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["trastuzumab","nivolumab","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05749900","phase":"1/2","setting":"First-line Trastuzumab Plus Chemoimmunotherapy for Biliary Tract Cancer (HERBOT Trial)","sponsor":"Yonsei University","started":"2023-05-12","startedType":"actual","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06616259","kind":"trial","name":"First-line Treatment of MCapOX + Cetuximab Vs. MFOLFOX6 + Cetuximab for RAS/BRAF Wild-type, MSS, Unresectable Left-Sided MCRC: a Multicenter, Randomized, Contro","aka":["CAPCET-III"],"tldr":"A phase 3 trial in colorectal cancer, run by Meng Qiu, not yet recruiting.","summary":"First-line Treatment of MCapOX + Cetuximab Vs. MFOLFOX6 + Cetuximab for RAS/BRAF Wild-type, MSS, Unresectable Left-Sided MCRC: a Multicenter, Randomized, Controlled, Phase III Study is a phase 3, randomised interventional study registered as NCT06616259 by Meng Qiu, with a registry enrolment figure of 452 participants, started 2024-09-26 and due to reach its primary completion in 2028-09-30. Interventions recorded: mCapOX plus Cetuximab; mFOLFOX6 plus Cetuximab. Conditions listed: Colorectal Cancer (CRC); Capecitabine; Cetuximab. Primary outcome: Progression free survival (PFS). Colorectal eligibility wording from the registry: \"* Patients with histologically or cytologically confirmed RAS and BRAF wild-type, MSS/pMMR, metastatic left-sided colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06616259","url":"https://clinicaltrials.gov/study/NCT06616259"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06616259","phase":"3","setting":"First-line Treatment of MCapOX in Combination with Cetuximab Versus MFOLFOX6 in Combination with Cetuximab for RAS/BRAF Wild-type, MSS, Unresectable Left-Sided Metastatic Colorectal Cancer: a Multicenter, Randomized, Controlled, Phase III Study","sponsor":"Meng Qiu","started":"2024-09-26","startedType":"estimated","enrolled":452,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07332455","kind":"trial","name":"First-Time-in-Human Study of GSK5471713 in Adults With mCRPC","aka":[],"tldr":"A phase 1/2 trial of GSK5471713 in prostate cancer, run by GlaxoSmithKline, now recruiting.","summary":"First-Time-in-Human Study of GSK5471713 in Adults With mCRPC is a phase 1/2 interventional study registered as NCT07332455 by GlaxoSmithKline, with 54 participants planned, started 2026-02-10 and due to reach its primary completion in 2028-03-24. Interventions recorded: GSK5471713.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07332455","url":"https://clinicaltrials.gov/study/NCT07332455"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07332455","phase":"1/2","setting":"A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Dose Optimization Study of GSK5471713 in Adult Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)","sponsor":"GlaxoSmithKline","started":"2026-02-10","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"firstana","kind":"trial","name":"FIRSTANA","aka":["FIRSTANA","cabazitaxel against docetaxel first line"],"tldr":"Cabazitaxel is no better than docetaxel as the first chemotherapy for castration-resistant prostate cancer. It is a different set of side effects, not a better drug.","summary":"FIRSTANA randomised 1,168 men with chemotherapy-naive metastatic castration-resistant prostate cancer 1:1:1 to cabazitaxel 20 mg/m2, cabazitaxel 25 mg/m2 or docetaxel 75 mg/m2 every 3 weeks with daily prednisone.\n\nMedian overall survival was 24.5 months with cabazitaxel 20, 25.2 months with cabazitaxel 25 and 24.3 months with docetaxel. The hazard ratio for cabazitaxel 20 against docetaxel was 1.01 (95 percent confidence interval 0.85 to 1.20, p=0.997) and for cabazitaxel 25 against docetaxel 0.97 (0.82 to 1.16, p=0.757). Median progression-free survival was 4.4, 5.1 and 5.3 months with no significant differences.\n\nRadiographic tumour responses were numerically higher with cabazitaxel 25 (41.6 percent) than docetaxel (30.9 percent), nominal p=0.037 without adjustment for multiplicity, but pain progression-free survival was numerically better with docetaxel.\n\nThe useful result is the toxicity contrast, because it lets a man and his oncologist choose on side effects when efficacy is equal. Grade 3 or 4 treatment-emergent adverse events occurred in 41.2 percent, 60.1 percent and 46.0 percent respectively. Febrile neutropenia, diarrhoea and haematuria were more frequent with cabazitaxel 25; peripheral neuropathy, peripheral oedema, alopecia and nail disorders were more frequent with docetaxel.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01308567","url":"https://clinicaltrials.gov/study/NCT01308567"},{"label":"FIRSTANA (Journal of Clinical Oncology 2017)","url":"https://doi.org/10.1200/JCO.2016.72.1068"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cabazitaxel","docetaxel","prednisone"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":["castration-resistance"],"trials":["tropic","proselica","tax-327"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01308567","phase":"3","setting":"Chemotherapy-naive metastatic castration-resistant prostate cancer with ECOG performance status 0 to 2: cabazitaxel 20 mg/m2, cabazitaxel 25 mg/m2 or docetaxel 75 mg/m2 every 3 weeks with daily prednisone, with overall survival as the primary endpoint","sponsor":"Sanofi","result":"Median overall survival 24.5, 25.2 and 24.3 months for cabazitaxel 20 mg/m2, cabazitaxel 25 mg/m2 and docetaxel; neither cabazitaxel dose was superior. Grade 3 or 4 adverse events 41.2, 60.1 and 46.0 percent, with different profiles.","started":"2011-05-05","startedType":"actual","yearReported":2017,"enrolled":1168,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Cabazitaxel 20 mg/m2","value":24.5,"note":"Hazard ratio is cabazitaxel 20 against docetaxel; cabazitaxel 25 against docetaxel was 0.97 (0.82 to 1.16, p=0.757)."},{"name":"Cabazitaxel 25 mg/m2","value":25.2},{"name":"Docetaxel 75 mg/m2","value":24.3}],"hr":1.01,"ci":[0.85,1.2],"p":"0.997","source":"https://doi.org/10.1200/JCO.2016.72.1068"},{"endpoint":"Grade 3 or 4 treatment-emergent adverse events","unit":"%","arms":[{"name":"Cabazitaxel 20 mg/m2","value":41.2},{"name":"Cabazitaxel 25 mg/m2","value":60.1},{"name":"Docetaxel 75 mg/m2","value":46}],"source":"https://doi.org/10.1200/JCO.2016.72.1068"}],"replication":"Consistent with PROSELICA, run in parallel, which showed the lower cabazitaxel dose is non-inferior after docetaxel; docetaxel remains the first taxane."},{"id":"nct07235930","kind":"trial","name":"Firstline Sequential AG and mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial of bevacizumab and gemcitabine + nab-paclitaxel in pancreatic cancer, run by Zhejiang Cancer Hospital, now recruiting.","summary":"Firstline Sequential AG and mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Advanced Pancreatic Cancer is a phase 3, randomised interventional study registered as NCT07235930 by Zhejiang Cancer Hospital, with a registry enrolment figure of 292 participants, started 2025-11-15 and due to reach its primary completion in 2029-07-01. Interventions recorded: Sequential AG and mFOLFOX in Combination With Serplulimab and Bevacizumab; AG chemotherapy. Conditions listed: Non-Resectable Pancreas Carcinoma. Primary outcome: Overall survival (OS). Pancreatic eligibility wording from the registry: \"Pancreatic ductal adenocarcinoma confirmed by pathologic histology or cytology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07235930","url":"https://clinicaltrials.gov/study/NCT07235930"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["bevacizumab","gemcitabine-nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07235930","phase":"3","setting":"Nab-Paclitaxel/Gemcitabine Followed by mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Previously Untreated Advanced Pancreatic Cancer: A Randomized, Controlled, Multicenter Phase III Trial","sponsor":"Zhejiang Cancer Hospital","started":"2025-11-15","startedType":"estimated","enrolled":292,"enrolledBasis":"registry","outcomes":[]},{"id":"firstmappp","kind":"trial","name":"FIRSTMAPPP","aka":["First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma","IGR2010/1715"],"tldr":"FIRSTMAPPP was the first randomised trial ever completed in metastatic phaeochromocytoma and paraganglioma, rare hormone-producing tumours; the kinase inhibitor sunitinib kept 36 percent of patients free of progression at a year against 19 percent on placebo, giving the disease its first drug with randomised evidence.","summary":"FIRSTMAPPP was an academic, double-blind, placebo-controlled phase 2 trial of the ENDOCAN-COMETE and ENSAT networks at 14 centres in four European countries, randomising 78 adults with progressive metastatic phaeochromocytoma or paraganglioma (a third with germline SDHx variants, two thirds previously treated) to sunitinib or placebo. The primary endpoint was progression-free survival at 12 months.\n\nThe primary endpoint was met: 14 of 39 patients on sunitinib (36 percent) were progression-free at 12 months against 7 of 39 on placebo (19 percent). Asthenia and hypertension were the common grade 3 or 4 adverse events; one drug-related death from rectal bleeding occurred. The corpus's metastatic phaeochromocytoma and paraganglioma page cites FIRSTMAPPP for sunitinib alongside belzutifan and cabozantinib.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01371201","url":"https://clinicaltrials.gov/study/NCT01371201"}],"tags":["soc-trials"],"related":[],"cancers":["metastatic-ppgl","pheochromocytoma-paraganglioma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["sunitinib"],"companies":[],"institutions":["gustave-roussy"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-firstmappp-sunitinib-metastatic-ppgl-baudin-lancet-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01371201","phase":"2","setting":"Progressive metastatic phaeochromocytoma or paraganglioma in adults at 14 European centres: sunitinib 37.5 mg daily or placebo (double-blind), with progression-free survival at 12 months as the primary endpoint","sponsor":"Gustave Roussy","result":"Progression-free survival at 12 months 36 percent with sunitinib against 19 percent with placebo, meeting the primary endpoint of the first randomised trial in the disease.","started":"2011-12-22","startedType":"actual","yearReported":2024,"enrolled":78,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 12 months","primary":true,"unit":"%","arms":[{"name":"Sunitinib 37.5 mg daily","n":39,"value":36,"note":"14 of 39; 90% CI 23 to 50"},{"name":"Placebo","n":39,"value":19,"note":"7 of 39; 90% CI 11 to 31"}],"source":"https://doi.org/10.1016/S0140-6736(23)02554-0"},{"endpoint":"Grade 3 or 4 asthenia","unit":"%","arms":[{"name":"Sunitinib 37.5 mg daily","n":39,"value":18},{"name":"Placebo","n":39,"value":3}],"source":"https://doi.org/10.1016/S0140-6736(23)02554-0"},{"endpoint":"Grade 3 or 4 hypertension","unit":"%","arms":[{"name":"Sunitinib 37.5 mg daily","n":39,"value":13},{"name":"Placebo","n":39,"value":10}],"source":"https://doi.org/10.1016/S0140-6736(23)02554-0"}]},{"id":"nct06636682","kind":"trial","name":"FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer","aka":[],"tldr":"A phase 2 trial of FK-PC101 in prostate cancer, run by Cellvax Therapeutics Inc, now recruiting.","summary":"FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer is a phase 2 interventional study registered as NCT06636682 by Cellvax Therapeutics Inc, with 100 participants planned, started 2024-10-14 and due to reach its primary completion in 2027-02-02. Interventions recorded: FK-PC101 and Standard of Care (SOC).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06636682","url":"https://clinicaltrials.gov/study/NCT06636682"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06636682","phase":"2","setting":"A Multicenter, Adaptive, Phase 2, Randomized, Open-label Study of Irradiated Autologous Cellular Vaccine in Men With High-Risk Prostate Cancer Following Prostatectomy","sponsor":"Cellvax Therapeutics Inc","started":"2024-10-14","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02448381","kind":"trial","name":"FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)","aka":[],"tldr":"A phase 3 trial of Synthetic hypericin in Cutaneous T-cell lymphoma, run by Soligenix, completed.","summary":"FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) is a phase 3 interventional study registered as NCT02448381 by Soligenix, with 169 participants recorded, started 2015-12 and reaching its primary completion in 2020-06. Interventions recorded: SGX301 (synthetic hypericin), Placebo. Conditions recorded: Cutaneous T-Cell Lymphoma.\n\nLinked to the drug Synthetic hypericin because the registry names it among its interventions and Cutaneous T-cell lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02448381","url":"https://clinicaltrials.gov/study/NCT02448381"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cutaneous-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["hypericin-sgx301"],"companies":["soligenix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02448381","phase":"3","setting":"A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma","sponsor":"Soligenix","started":"2015-12","startedType":"actual","yearReported":2022,"enrolled":169,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score When Compared to Patients Receiving Placebo, Responder","primary":true,"unit":"participants","arms":[{"name":"SGX301","n":116,"value":19,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-04-15), not from a publication"},{"name":"Placebo","n":50,"value":2}],"p":"0.04","source":"https://clinicaltrials.gov/study/NCT02448381?tab=results"}]},{"id":"nct07455331","kind":"trial","name":"Flash Radiotherapy for Skin Cancer","aka":[],"tldr":"A phase 2 trial of FLASH radiotherapy in Cutaneous squamous cell carcinoma and Basal cell carcinoma, run by Jules Bordet Institute, not yet recruiting.","summary":"Flash Radiotherapy for Skin Cancer is a phase 2 interventional study registered as NCT07455331 by Jules Bordet Institute, with 60 participants planned, started 2026-06-23 and due to reach its primary completion in 2029-12-23. Interventions recorded: FLASH radiotherapy, Conventional radiotherapy. Conditions recorded: Cutaneous Squamous Cell Carcinoma (CSCC), Basal Cell Carcinoma (BCC).\n\nLinked to the technology FLASH radiotherapy because the registry names it (\"flash radiotherapy\") among its interventions and Cutaneous squamous cell carcinoma and Basal cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07455331","url":"https://clinicaltrials.gov/study/NCT07455331"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cutaneous-scc","basal-cell-carcinoma"],"sections":[],"technologies":["flash-rt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07455331","phase":"2","setting":"Randomized Phase II Selection Trial of FLASH Versus Conventional Radiotherapy for Participants With Localized Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma","sponsor":"Jules Bordet Institute","started":"2026-06-23","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"flaura","kind":"trial","name":"FLAURA","aka":[],"tldr":"FLAURA showed that starting with the third-generation EGFR drug osimertinib, rather than saving it for later, kept lung cancer under control for almost twice as long and helped people live longer.","summary":"FLAURA randomised 556 patients with untreated advanced non-small-cell lung cancer carrying an EGFR exon 19 deletion or L858R mutation to osimertinib or to a first-generation inhibitor, gefitinib or erlotinib. Osimertinib had been designed to hit the T790M resistance mutation and to spare wild-type EGFR, and the question was whether using it first beat using it after the older drugs failed.\n\nMedian progression-free survival was 18.9 months with osimertinib against 10.2 months with the comparator (hazard ratio 0.46), with fewer brain progressions and less rash and diarrhoea. The final analysis in 2020 showed median overall survival of 38.6 months against 31.8 months (hazard ratio 0.80), even though a third of the comparator arm crossed over to osimertinib.\n\nThe FDA approved osimertinib for first-line use in April 2018 and it became the standard against which FLAURA2 and MARIPOSA were later measured.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02296125","url":"https://clinicaltrials.gov/study/NCT02296125"},{"label":"New England Journal of Medicine 2018","url":"https://doi.org/10.1056/NEJMoa1713137"},{"label":"New England Journal of Medicine 2020 (overall survival)","url":"https://doi.org/10.1056/NEJMoa1913662"}],"tags":[],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["egfr"],"drugs":["osimertinib","gefitinib","erlotinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["egfr-exon19-l858r","tki-term"],"trials":[],"people":["jean-charles-soria","suresh-ramalingam"],"bottlenecks":[],"keyPapers":["paper-flaura-nejm-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02296125","phase":"3","setting":"Untreated advanced non-small-cell lung cancer with an EGFR exon 19 deletion or L858R mutation: osimertinib versus gefitinib or erlotinib","sponsor":"AstraZeneca","result":"Median progression-free survival 18.9 vs 10.2 months (hazard ratio 0.46); median overall survival 38.6 vs 31.8 months (hazard ratio 0.80).","started":"2014-12-03","startedType":"actual","yearReported":2018,"enrolled":556,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Osimertinib","n":279,"value":18.9},{"name":"Gefitinib or erlotinib","n":277,"value":10.2}],"hr":0.46,"source":"https://doi.org/10.1056/NEJMoa1713137"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Osimertinib","n":279,"value":38.6},{"name":"Gefitinib or erlotinib","n":277,"value":31.8}],"hr":0.8,"source":"https://doi.org/10.1056/NEJMoa1913662"}],"replication":"FLAURA2 and MARIPOSA both used osimertinib as the control and reproduced its progression-free survival; the Chinese FLAURA China cohort matched the global result."},{"id":"flaura2","kind":"trial","name":"FLAURA2","aka":[],"tldr":"Adding chemotherapy to osimertinib extended both progression-free and, in 2025, overall survival.","summary":"FLAURA2, trial NCT04035486 sponsored by AstraZeneca and published in the New England Journal of Medicine in 2023, showed that adding platinum chemotherapy to first-line osimertinib in EGFR-mutant non-small-cell lung cancer extends progression-free survival and, in 2025, overall survival. It randomised 557 patients to osimertinib with or without chemotherapy and met its primary investigator-assessed progression-free survival endpoint, with the survival benefit reported later. OnCo links it to non-small-cell lung cancer, osimertinib, Suresh S. Ramalingam, Pasi A. Jänne, Guangdong Provincial People's Hospital, FURLONG, the bottleneck of acquired resistance, the idea of alternating schedules and the FLAURA and MARIPOSA papers. The two regimens have never been compared directly, and which patients need intensification is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT04035486","url":"https://clinicaltrials.gov/study/NCT04035486"}],"tags":[],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["suresh-ramalingam","pasi-janne"],"bottlenecks":[],"keyPapers":["paper-flaura-nejm-2018","paper-mariposa-nejm-2024","paper-flaura2-long-term-safety-lung-cancer-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04035486","phase":"3","setting":"First-line EGFR-mutant NSCLC: osimertinib + chemotherapy vs osimertinib","sponsor":"AstraZeneca","result":"PFS HR 0.62; OS HR 0.77.","started":"2019-07-02","startedType":"actual","yearReported":2023,"enrolled":587,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (investigator)","primary":true,"unit":"months","arms":[{"name":"Osimertinib + chemotherapy","n":279,"value":25.5},{"name":"Osimertinib","n":278,"value":16.7}],"hr":0.62,"ci":[0.49,0.79],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2306434"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Osimertinib + chemotherapy","value":47.5},{"name":"Osimertinib","value":37.6}],"hr":0.77,"ci":[0.61,0.96],"p":"0.02","source":"https://clinicaltrials.gov/study/NCT04035486"}],"replication":"Consistent with MARIPOSA in showing that intensifying first-line therapy beyond osimertinib alone extends survival; the two regimens have not been compared directly."},{"id":"flot4","kind":"trial","name":"FLOT4-AIO","aka":["FLOT4","AIO-FLOT4"],"tldr":"FLOT4 showed that a docetaxel-based chemotherapy given before and after surgery helped people with operable stomach and junction cancers live longer than the older epirubicin-based regimen, and FLOT became the standard perioperative treatment in Europe.","summary":"The German FLOT4-AIO trial randomised 716 patients with resectable adenocarcinoma of the stomach or gastro-oesophageal junction (clinical stage T2 or higher, or node-positive) to four cycles before and four after surgery of FLOT (fluorouracil, leucovorin, oxaliplatin and docetaxel) or three cycles before and after of ECF or ECX (epirubicin, cisplatin, and fluorouracil or capecitabine), the regimen established by the MAGIC trial. The phase 2 part compared pathological response; the phase 3 primary endpoint was overall survival.\n\nFLOT increased the rate of complete or near-complete pathological regression and lengthened overall survival compared with ECF or ECX, with a similar rate of surgical complications. It replaced the anthracycline triplet as the perioperative standard in Europe and is the backbone that ESOPEC, MATTERHORN and other trials have since built on.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01216644","url":"https://clinicaltrials.gov/study/NCT01216644"}],"tags":["subtype-trials"],"related":[],"cancers":["oesophageal-adenocarcinoma","esophageal","gastric"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","leucovorin","oxaliplatin","docetaxel","epirubicin","cisplatin","capecitabine"],"companies":["aio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["salah-eddin-al-batran"],"bottlenecks":[],"keyPapers":["paper-flot4-lancet-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01216644","phase":"2/3","setting":"Resectable gastric or gastro-oesophageal junction adenocarcinoma: perioperative FLOT (fluorouracil, leucovorin, oxaliplatin, docetaxel) against perioperative ECF or ECX","sponsor":"Krankenhaus Nordwest (AIO)","result":"Perioperative FLOT improved overall survival over ECF or ECX in resectable gastric and junctional adenocarcinoma.","started":"2010-08","startedType":"actual","yearReported":2019,"enrolled":716,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Perioperative FLOT","n":356,"value":50},{"name":"Perioperative ECF/ECX","n":360,"value":35}],"hr":0.77,"ci":[0.63,0.94],"source":"https://doi.org/10.1016/S0140-6736(18)32557-1"},{"endpoint":"Related serious adverse events","unit":"%","arms":[{"name":"Perioperative FLOT","value":27},{"name":"Perioperative ECF/ECX","value":27}],"source":"https://doi.org/10.1016/S0140-6736(18)32557-1"}]},{"id":"nct00254163","kind":"trial","name":"Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients","aka":[],"tldr":"A phase 3 trial of Fludarabine, Cyclophosphamide, Rituximab and Pentostatin in Chronic lymphocytic leukaemia, run by US Oncology Research, completed.","summary":"Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients is a phase 3 interventional study registered as NCT00254163 by US Oncology Research, with 184 participants recorded, started 2003-12 and reaching its primary completion in 2011-09. Interventions recorded: Fludarabine, Cyclophosphamide, Rituximab, Pentostatin. Conditions recorded: B-Cell Chronic Lymphocytic Leukemia.\n\nLinked to the drug Pentostatin because the registry names it among its interventions and Chronic lymphocytic leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00254163","url":"https://clinicaltrials.gov/study/NCT00254163"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":[],"targets":[],"drugs":["fludarabine","cyclophosphamide","rituximab","pentostatin"],"companies":["mckesson-us-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00254163","phase":"3","setting":"A Prospective, Randomized, Open Label, Phase III Trial of Fludarabine, Cyclophosphamide, and Rituximab vs. Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-cell Chronic Lymphocytic Leukemia","sponsor":"US Oncology Research","started":"2003-12","yearReported":2016,"enrolled":184,"enrolledBasis":"registry","outcomes":[{"endpoint":"Infection Rate","primary":true,"unit":"%","arms":[{"name":"FCR Arm","n":86,"value":31.4,"note":"95% CI 21.8 to 42.3; Figures from the ClinicalTrials.gov results section (first posted 2016-11-03), not from a publication"},{"name":"PCR Arm","n":85,"value":36.5,"note":"95% CI 26.3 to 47.6"}],"source":"https://clinicaltrials.gov/study/NCT00254163?tab=results"},{"endpoint":"Progression-free Survival (PFS) Rate at 1-year","unit":"probability of progression-free survival","arms":[{"name":"FCR Arm","n":86,"value":0.86,"note":"95% CI 0.76 to 0.92; Figures from the ClinicalTrials.gov results section (first posted 2016-11-03), not from a publication"},{"name":"PCR Arm","n":85,"value":0.84,"note":"95% CI 0.74 to 0.90"}],"source":"https://clinicaltrials.gov/study/NCT00254163?tab=results"},{"endpoint":"Objective Remission Rate (ORR)","unit":"%","arms":[{"name":"FCR Arm","n":86,"value":59.3,"note":"95% CI 48.2 to 69.8; Figures from the ClinicalTrials.gov results section (first posted 2016-11-03), not from a publication"},{"name":"PCR Arm","n":85,"value":49.4,"note":"95% CI 38.4 to 60.5"}],"source":"https://clinicaltrials.gov/study/NCT00254163?tab=results"}]},{"id":"nct06307548","kind":"trial","name":"Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurre","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by Roswell Park Cancer Institute, now recruiting.","summary":"Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer is a phase 1/2, interventional study registered as NCT06307548 by Roswell Park Cancer Institute, with a registry enrolment figure of 21 participants, started 2024-07-30 and due to reach its primary completion in 2027-06-01. Interventions recorded: Aminolevulinic Acid; Biospecimen Collection; Computed Tomography; Fluorescence-Guided Surgery; Magnetic Resonance Imaging; Photodynamic Therapy; Surgical Procedure. Conditions listed: Locally Advanced Colorectal Carcinoma; Recurrent Colorectal Carcinoma; Stage III Colorectal Cancer. Primary outcome: Accuracy of the fluorescence imaging (Phase I); Incidence of adverse events (Phase I); Evidence of disease (Phase II). Colorectal eligibility wording from the registry: \"* Patients with locally advanced or recurrent colorectal cancer undergoing surgery\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06307548","url":"https://clinicaltrials.gov/study/NCT06307548"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06307548","phase":"1/2","setting":"Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Loco-Regionally Advanced or Recurrent Colorectal Cancer Undergoing Surgery - Phase I/II","sponsor":"Roswell Park Cancer Institute","started":"2024-07-30","startedType":"actual","enrolled":21,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07060443","kind":"trial","name":"Fluorescence Lymph Node Mapping for Colon Cancer Surgery","aka":["CONSTELLARE"],"tldr":"A phase 2 trial in colorectal cancer, run by Pusan National University Yangsan Hospital, now recruiting.","summary":"Fluorescence Lymph Node Mapping for Colon Cancer Surgery is a phase 2, randomised interventional study registered as NCT07060443 by Pusan National University Yangsan Hospital, with a registry enrolment figure of 186 participants, started 2025-07-23 and due to reach its primary completion in 2028-12-31. Interventions recorded: Indocyanine green (ICG) injection for intraoperative lymph node imaging; Standard Right Hemicolectomy (Non-ICG). Conditions listed: Right Hemicolectomy. Primary outcome: Pathological D3 lymph node metastasis detection rate. Colorectal eligibility wording from the registry: \"Patient with locally advanced right colon cancer requiring D3 lymphadenectomy\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07060443","url":"https://clinicaltrials.gov/study/NCT07060443"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["robotic-surgery"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07060443","phase":"2","setting":"Clinico-oncological Safety and Efficacy of Real-time Fluorescence Lymph Node Mapping (FLNM) in Laparoscopic and Robotic Right Hemicolectomy for Patients With Locally Advanced Right-sided Colon Cancer; Multicenter Phase II Open Labelled Randomized Controlled Trial","sponsor":"Pusan National University Yangsan Hospital","started":"2025-07-23","startedType":"estimated","enrolled":186,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06385418","kind":"trial","name":"Fluorouracil Treatment Via Colon for Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by The Second Hospital of Nanjing Medical University, now recruiting.","summary":"Fluorouracil Treatment Via Colon for Colorectal Cancer is a phase 2, interventional study registered as NCT06385418 by The Second Hospital of Nanjing Medical University, with a registry enrolment figure of 40 participants, started 2024-05-16 and due to reach its primary completion in 2028-05-01. Interventions recorded: Colonic local administration of fluorouracil with enhanced adhesion. Conditions listed: Colorectal Cancer. Primary outcome: Objective response rate (according to RECIST1.1, investigator assessment). Colorectal eligibility wording from the registry: \"Histologically confirmed diagnosis of colorectal cancer with measurable primary lesion according to RECIST 1\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06385418","url":"https://clinicaltrials.gov/study/NCT06385418"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06385418","phase":"2","setting":"Fluorouracil Treatment Via Colon for Colorectal Cancer: an Exploratory Study","sponsor":"The Second Hospital of Nanjing Medical University","started":"2024-05-16","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00002881","kind":"trial","name":"Flutamide, Suramin, and Hydrocortisone in Treating Patients With Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Flutamide, Goserelin / leuprolide and Leuprolide in Prostate cancer, run by Eastern Cooperative Oncology Group, completed.","summary":"Flutamide, Suramin, and Hydrocortisone in Treating Patients With Prostate Cancer is a phase 3 interventional study registered as NCT00002881 by Eastern Cooperative Oncology Group, started 1996-10 and reaching its primary completion in 1998-04. Interventions recorded: flutamide, goserelin acetate, leuprolide acetate, suramin, therapeutic hydrocortisone, orchiectomy. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Flutamide because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00002881","url":"https://clinicaltrials.gov/study/NCT00002881"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["flutamide","goserelin","leuprolide"],"companies":["ecog-acrin"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002881","phase":"3","setting":"PHASE III TRIAL OF ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE + SURAMIN + HYDROCORTISONE VS ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE IN PATIENTS WITH METASTATIC PROSTATE CANCER","sponsor":"Eastern Cooperative Oncology Group","started":"1996-10","enrolledBasis":"registry","outcomes":[]},{"id":"flyer","kind":"trial","name":"FLYER","aka":["Four versus six cycles of CHOP with rituximab","FLYER trial"],"tldr":"Young people with early, low-risk aggressive lymphoma got two fewer rounds of chemotherapy and did just as well, with about a third fewer side effects recorded.","summary":"FLYER asked the de-escalation question that matters most to a 30-year-old: how little chemotherapy is enough. It enrolled people aged 18 to 60 with stage I or II aggressive B-cell non-Hodgkin lymphoma, a normal serum lactate dehydrogenase, performance status 0 or 1 and no bulky mass, at 138 sites in Germany, Denmark, Israel, Italy and Norway, and randomised them between six cycles of R-CHOP and four cycles of CHOP with six doses of rituximab.\n\nAt a median follow-up of 66 months, three-year progression-free survival with four cycles was 96 per cent (95 per cent confidence interval 94 to 99), 3 percentage points better than six cycles, which established non-inferiority against a margin of minus 5.5 points. The toxicity difference is the point of the trial: 294 haematological and 1,036 non-haematological adverse events in the four-cycle group against 426 and 1,280 in the six-cycle group. Two patients died during study therapy, both in the six-cycle group.\n\nFLYER is why a young person with favourable limited-stage disease is now routinely offered four cycles rather than six, and why the conversation about radiotherapy in that setting is separate from the conversation about chemotherapy duration: no radiotherapy was planned in either arm except for testicular lymphoma.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT00278421","url":"https://clinicaltrials.gov/study/NCT00278421"},{"label":"Lancet 2019","url":"https://doi.org/10.1016/S0140-6736(19)33008-9"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["dlbcl","non-hodgkin-lymphoma"],"sections":["chemotherapy","immunotherapy"],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":[],"institutions":[],"pathways":[],"terms":["r-chop","non-inferiority","ipi-score"],"trials":[],"people":[],"bottlenecks":["b-toxicity-qol","b-survivorship"],"keyPapers":["paper-flyer-four-vs-six-cycles-r-chop-lancet-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00278421","phase":"3","setting":"Aged 18 to 60 with stage I or II aggressive B-cell lymphoma, normal lactate dehydrogenase, no bulk: four cycles of R-CHOP with six doses of rituximab against six cycles of R-CHOP","sponsor":"German High-Grade Non-Hodgkin's Lymphoma Study Group","result":"Three-year progression-free survival 96 per cent with four cycles of R-CHOP plus two extra rituximab doses, non-inferior to six cycles, with roughly a quarter fewer adverse events.","started":"2005-11","yearReported":2019,"enrolled":588,"enrolledBasis":"analysed","enrolledNote":"The registry records 592 enrolled; four patients withdrew consent before treatment, so the intention-to-treat analysis covers 588.","outcomes":[{"endpoint":"Progression-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Four cycles R-CHOP plus two rituximab","n":293,"value":96},{"name":"Six cycles R-CHOP","n":295,"note":"3 percentage points lower; the one-sided 95 per cent confidence interval for the difference had a lower limit of 0 per cent"}],"source":"https://doi.org/10.1016/S0140-6736(19)33008-9"}],"replication":"Consistent with the direction of the earlier MInT and RICOVER-60 work from the same group; no independent randomised repeat."},{"id":"nct07378306","kind":"trial","name":"FMD and Neoadjuvant Chemo-immunotherapy in TNBC","aka":["FACT-TN"],"tldr":"A phase 2 trial of toripalimab in triple-negative breast cancer, run by Sun Yat-sen University, now recruiting.","summary":"FMD and Neoadjuvant Chemo-immunotherapy in TNBC is a phase 2, interventional study registered as NCT07378306 by Sun Yat-sen University, with a registry enrolment figure of 80 participants, started 2026-03-05 and due to reach its primary completion in 2029-06-30. Interventions recorded: Fasting-mimicking diet; Chemotherapy; Toripalimab. Conditions listed: Breast Cancer. Triple-negative eligibility wording from the registry: \"* Triple-negative or near-triple-negative subtype, defined as HR-negative or low expression (ER and/or PR positivity rate 1%-10%) and HER2-negative (IHC 0, 1+, or 2+ with FISH-negative)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07378306","url":"https://clinicaltrials.gov/study/NCT07378306"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07378306","phase":"2","setting":"FAsting-mimicking Diet in Combination With Neoadjuvant Chemo-immunoTherapy for Early or Locally Advanced Triple-Negative Breast Cancer: the Prospective, Single-arm, Open-lable, Phase 2 FACT-TN Trial","sponsor":"Sun Yat-sen University","started":"2026-03-05","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07509398","kind":"trial","name":"FMT Combined With Standard First-Line Therapy in Initially Unresectable Colorectal Cancer","aka":[],"tldr":"A phase 2/3 trial in colorectal cancer, run by Shanghai 10th People's Hospital, not yet recruiting.","summary":"FMT Combined With Standard First-Line Therapy in Initially Unresectable Colorectal Cancer is a phase 2/3, randomised interventional study registered as NCT07509398 by Shanghai 10th People's Hospital, with a registry enrolment figure of 220 participants, started 2026-04 and due to reach its primary completion in 2027-12. Interventions recorded: Standard First-Line Therapy; FMT Combined with Standard First-Line Therapy. Conditions listed: Unresectable Colorectal Cancer; Colorectal Cancer (Locally Advanced or Metastatic). Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"(3) Meet the defined criteria for initially unresectable advanced metastatic colorectal cancer (mCRC) for this project\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07509398","url":"https://clinicaltrials.gov/study/NCT07509398"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07509398","phase":"2/3","setting":"Efficacy and Safety of Fecal Microbiota Transplantation Combined With First-Line Standard Therapy in Patients With Initially Unresectable Colorectal Cancer: A Multicenter, Open-Label, Randomized Controlled Trial","sponsor":"Shanghai 10th People's Hospital","started":"2026-04","startedType":"estimated","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07292142","kind":"trial","name":"FMT in Triple Negative Breast Cancer Guided by ctDNA","aka":["FRIDA"],"tldr":"A phase 1/2 trial in triple-negative breast cancer, run by Jewish General Hospital, not yet recruiting.","summary":"FMT in Triple Negative Breast Cancer Guided by ctDNA is a phase 1/2, interventional study registered as NCT07292142 by Jewish General Hospital, with a registry enrolment figure of 125 participants, started 2026-02 and due to reach its primary completion in 2029-12. Interventions recorded: Fecal Microbiota Transplantation (FMT); No Intervention.. Conditions listed: Breast Cancer. Triple-negative eligibility wording from the registry: \"* Patients must have a confirmed diagnosis of TNBC (defined as estrogen receptor expression 0-10%, progesterone receptor expression 0-10%, and HER-2/neu negative (immunohistochemistry 0, 1+, or 2+ and fluorescent in-situ hybridization negative for HER-2 gene amplification) and are about to start neo\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07292142","url":"https://clinicaltrials.gov/study/NCT07292142"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07292142","phase":"1/2","setting":"FMT in Triple Negative Breast Cancer Guided by ctDNA","sponsor":"Jewish General Hospital","started":"2026-02","startedType":"estimated","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"fmt-pd1-refractory-melanoma-pitt","kind":"trial","name":"FMT plus pembrolizumab in anti-PD-1-refractory melanoma (Pittsburgh)","aka":[],"tldr":"Fifteen melanoma patients whose immunotherapy had failed received a stool transplant from someone whose immunotherapy had worked, then restarted the drug. Six of them benefited, including three with lasting responses.","summary":"Single-arm study. Donors were seven melanoma patients with complete or durable partial responses to anti-PD-1. Of 15 recipients, 6 had clinical benefit (3 objective responses, 3 stable disease beyond 12 months); responders showed engraftment of donor taxa, increased CD8 T-cell activation and decreased IL-8-producing myeloid cells, and lower circulating IL-8. A companion Israeli study (Sheba, NCT03353402, 10 patients, 3 responders) was published alongside. Together they were the first human evidence that manipulating the microbiome can reverse checkpoint resistance, and they set off the current wave of randomised FMT and defined-consortium trials. Small, uncontrolled, and with a response rate a sceptic could attribute to re-challenge alone.","status":"completed","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT03341143","url":"https://clinicaltrials.gov/study/NCT03341143"},{"label":"Davar et al. (Science 2021)","url":"https://doi.org/10.1126/science.abf3363"},{"label":"Baruch et al., Sheba (Science 2021)","url":"https://doi.org/10.1126/science.abb5920"}],"tags":[],"related":["idea-microbiome-io-fmt","idea-bio2-fmt-plus-checkpoint-phase3"],"cancers":["melanoma"],"sections":["nutrition-lifestyle","immunotherapy"],"technologies":["fmt-checkpoint-nonresponders","microbiome-modulation-io","checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":["microbiome-tumour"],"terms":["gut-microbiome-diversity","orr"],"trials":[],"people":["jennifer-wargo"],"bottlenecks":["b-immunotherapy-response"],"keyPapers":["paper-davar-science","paper-baruch-science"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03341143","phase":"2","setting":"Metastatic melanoma with primary resistance to anti-PD-1: single colonoscopic FMT from a durable responder donor, then pembrolizumab","sponsor":"UPMC Hillman Cancer Center / NCI","result":"6 of 15 patients with clinical benefit (3 objective responses).","started":"2018-03-19","startedType":"actual","yearReported":2021,"enrolled":15,"enrolledBasis":"treated","enrolledNote":"ClinicalTrials.gov lists 20 participants (actual); the Science 2021 paper reports outcomes for the 15 patients who received FMT plus pembrolizumab.","outcomes":[{"endpoint":"Clinical benefit (objective response or SD over 12 months)","primary":true,"unit":"%","arms":[{"name":"FMT + pembrolizumab","n":15,"value":40}],"source":"https://doi.org/10.1126/science.abf3363"}],"replication":"Sheba study (Science 2021) concordant; randomised phase 2 trials (LND101 NCT06623461; Oslo NCT05286294) in progress."},{"id":"nct06801665","kind":"trial","name":"FMT+ QL1706+Bevacizumab+ XELOX as First-line Treatment for Advanced MSS-type Colorectal Cancer With Liver Metastasis","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Hua Jiang, now recruiting.","summary":"FMT+ QL1706+Bevacizumab+ XELOX as First-line Treatment for Advanced MSS-type Colorectal Cancer With Liver Metastasis is a phase 2, interventional study registered as NCT06801665 by Hua Jiang, with a registry enrolment figure of 30 participants, started 2025-04-17 and due to reach its primary completion in 2027-02-01. Interventions recorded: FMT+QL1706+Bevacizumab+XELOX. Conditions listed: Colorectal Cancer Liver Metastasis. Primary outcome: Objective Response Rate (ORR). Colorectal eligibility wording from the registry: \"Histological or cytological confirmed advanced colorectal cancer with liver metastasis\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06801665","url":"https://clinicaltrials.gov/study/NCT06801665"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06801665","phase":"2","setting":"Fecal Microbiota Transplantation Combined With QL1706, Bevacizumab, and XELOX as First-line Treatment for Advanced MSS-type Colorectal Cancer With Liver Metastasis: A Prospective, Multi-center, Single-arm Phase II Study","sponsor":"Hua Jiang","started":"2025-04-17","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01883128","kind":"trial","name":"FOcal RECurrent Assessment and Salvage Treatment","aka":[],"tldr":"A phase 2 trial of Whole-body MRI in Prostate cancer, run by University College London Hospitals, with a status the registry has not verified recently.","summary":"FOcal RECurrent Assessment and Salvage Treatment is a phase 2 interventional study registered as NCT01883128 by University College London Hospitals, with 177 participants planned, started 2014-04 and due to reach its primary completion in 2019-10. Interventions recorded: Whole Body MRI, Focal Salvage Therapy, MRI Targeted biopsies. Conditions recorded: Progression of Prostate Cancer.\n\nLinked to the technology Whole-body MRI because the registry names it (\"whole body mri\") among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01883128","url":"https://clinicaltrials.gov/study/NCT01883128"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["whole-body-mri"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01883128","phase":"2","setting":"An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.","sponsor":"University College London Hospitals","started":"2014-04","startedType":"actual","enrolled":177,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02678572","kind":"trial","name":"FOCUS","aka":["PHP-OCM-301A","PHP-OCM-301","Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma"],"tldr":"FOCUS showed that pumping high-dose melphalan through the liver's blood supply, then filtering it out before the blood returns to the body, shrank tumours in about one in three patients whose eye melanoma had spread to the liver, and it supported the treatment's US approval in 2023.","summary":"FOCUS was an open-label phase 3 trial of melphalan delivered by percutaneous hepatic perfusion with the Hepatic Delivery System in patients with unresectable metastatic uveal melanoma and liver-dominant disease. Of 102 patients enrolled, treatment was attempted in 95 and 91 received it. Melphalan 3 mg per kg ideal body weight was given once every 6 to 8 weeks for up to six cycles. The primary endpoint was objective response rate by independent central review, judged against the upper confidence bound of a benchmark meta-analysis. The registry's outcome definitions date events from the eligibility date for PHP-OCM-301A patients and from the randomisation date for PHP-OCM-301 patients, the trace of an earlier randomised phase of the same study.\n\nIn the 91 treated patients the objective response rate was 36.3 percent (95% CI 26.44 to 47.01), including complete responses in 7.7 percent. The lower confidence bound exceeded the 8.3 percent benchmark, so the study met its primary endpoint. Median duration of response was 14 months, median overall survival 20.5 months (80 percent alive at 1 year) and median progression-free survival 9 months (65 percent progression-free at 6 months). The most common serious treatment-emergent adverse events were thrombocytopenia (15.8 percent) and neutropenia (10.5 percent), and there were no treatment-related deaths (Annals of Surgical Oncology 2024). The registry results section adds a disease control rate of 73.6 percent and gives the duration-of-response median as 14.00 months (95% CI 8.31 to 17.74).\n\nFOCUS is the efficacy trial in the US label of the Hepzato Kit, approved in August 2023, whose Table 4 reports the same 36.3 percent response (complete 7.7 percent, partial 28.6 percent) and a median duration of response of 14.0 months among 33 responders. Its result is judged against a historical benchmark rather than a concurrent control, and it did not compare liver-directed treatment with tebentafusp, which improved overall survival in HLA-A*02:01-positive metastatic uveal melanoma in IMCgp100-202.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02678572","url":"https://clinicaltrials.gov/study/NCT02678572"},{"label":"Annals of Surgical Oncology 2024","url":"https://doi.org/10.1245/s10434-024-15293-x"},{"label":"Hepzato Kit label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f83c8f7-4cc0-4219-88d5-7cfddce91198"}],"tags":[],"related":["imcgp100-202","nct06519266"],"cancers":["uveal-melanoma"],"sections":[],"technologies":["percutaneous-hepatic-perfusion"],"targets":[],"drugs":["hepzato","melphalan"],"companies":["delcath"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["reinhard-dummer"],"bottlenecks":[],"keyPapers":["paper-zager-ann-surg-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02678572","phase":"3","setting":"Unresectable liver-dominant metastatic uveal melanoma: melphalan by percutaneous hepatic perfusion with the Hepatic Delivery System, single arm, judged against a historical benchmark","sponsor":"Delcath Systems Inc.","result":"Objective response rate 36.3% by independent central review in 91 treated patients (complete response 7.7%), above the prespecified historical benchmark; median duration of response 14 months and median overall survival 20.5 months.","started":"2016-02-01","startedType":"actual","yearReported":2024,"enrolled":102,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (independent central review, treated population)","primary":true,"unit":"%","arms":[{"name":"Melphalan / Hepatic Delivery System","n":91,"value":36.3,"note":"95% CI 26.44 to 47.01; complete response 7.7%"}],"source":"https://doi.org/10.1245/s10434-024-15293-x"},{"endpoint":"Duration of response (independent central review)","unit":"months","arms":[{"name":"Melphalan / Hepatic Delivery System","n":33,"value":14,"note":"Responders only (33 in the US label Table 4)"}],"source":"https://doi.org/10.1245/s10434-024-15293-x"},{"endpoint":"Progression-free survival (treated population)","unit":"months","arms":[{"name":"Melphalan / Hepatic Delivery System","n":91,"value":9,"note":"65% progression-free at 6 months"}],"source":"https://doi.org/10.1245/s10434-024-15293-x"},{"endpoint":"Overall survival (treated population)","unit":"months","arms":[{"name":"Melphalan / Hepatic Delivery System","n":91,"value":20.5,"note":"80% alive at 1 year"}],"source":"https://doi.org/10.1245/s10434-024-15293-x"},{"endpoint":"Disease control rate (independent central review, treated population)","unit":"%","arms":[{"name":"Melphalan / Hepatic Delivery System","n":91,"value":73.6,"note":"95% CI 63.35 to 82.31; registry results section"}],"source":"https://clinicaltrials.gov/study/NCT02678572?tab=results"}],"replication":"Single-arm result judged against a historical benchmark; the randomised phase 3 NCT06519266 tests percutaneous hepatic perfusion added to ipilimumab and nivolumab against ipilimumab and nivolumab alone."},{"id":"focus4","kind":"trial","name":"FOCUS4","aka":["FOCUS4 trial","FOCUS4-N","FOCUS4-C","FOCUS4-D","MRC FOCUS4"],"tldr":"FOCUS4 was Britain's molecularly stratified platform in bowel cancer: after four months of chemotherapy, patients were sorted by their tumour's mutations and offered a matching maintenance drug or a break. Its two clear results were that a WEE1 inhibitor slowed cancers with both RAS and TP53 mutations, and that maintenance capecitabine delays progression but does not extend life.","summary":"FOCUS4 ran from 2014 to 2020 from the MRC Clinical Trials Unit at UCL, led by Tim Maughan, Matthew Seymour, Richard Adams and Richard Kaplan, with laboratory stratification at Leeds and Cardiff. Patients with metastatic colorectal cancer whose disease was stable or responding after 16 weeks of first-line chemotherapy had their tumour tested for BRAF, PIK3CA, RAS and TP53 and mismatch repair status, then entered the matching randomised comparison during a planned treatment break: FOCUS4-D for BRAF, PIK3CA and RAS wild-type tumours (the pan-HER inhibitor AZD8931 against placebo), FOCUS4-C for tumours with both RAS and TP53 mutations (the WEE1 inhibitor adavosertib against active monitoring), FOCUS4-B for PIK3CA-mutant tumours, and FOCUS4-N, open to any biomarker group, comparing maintenance capecitabine with active monitoring. The multi-arm multi-stage design allowed arms to stop early for lack of activity or add new drugs.\n\nFOCUS4-D closed for futility in 2018 with no benefit from AZD8931. FOCUS4-C, published in the Journal of Clinical Oncology in 2021, found that adavosertib improved progression-free survival against active monitoring in RAS and TP53 co-mutated cancers (hazard ratio 0.35), the first clinical signal for WEE1 inhibition selected by this pair of mutations, with a non-significant trend to longer overall survival. FOCUS4-N, also in the Journal of Clinical Oncology in 2021, showed maintenance capecitabine improved progression-free survival (hazard ratio 0.40) but not overall survival, supporting treatment breaks as a reasonable choice. The platform closed in 2020 as the COVID-19 pandemic and the withdrawal of several planned drugs made further arms impractical; the full programme was published as a monograph in 2022 alongside a candid account of the lessons of running a stratified platform for a decade.\n\nWhat FOCUS4 changed is British colorectal practice on maintenance therapy and the design of later UK platforms: it proved that a national trials unit could stratify by biomarker within the NHS, and it showed the cost of relying on industry to supply drugs to an academic platform when candidate agents are withdrawn. The adavosertib signal has not yet been taken into a confirmatory trial.","status":"completed","asOf":"2026-09-17","links":[{"label":"ISRCTN90061546: FOCUS4 registry entry","url":"https://www.isrctn.com/ISRCTN90061546"},{"label":"Seligmann et al., Journal of Clinical Oncology 2021: inhibition of WEE1 is effective in TP53- and RAS-mutant metastatic colorectal cancer (FOCUS4-C)","url":"https://doi.org/10.1200/JCO.21.01435"},{"label":"Adams et al., Journal of Clinical Oncology 2021: capecitabine versus active monitoring in stable or responding metastatic colorectal cancer after 16 weeks of first-line therapy (FOCUS4-N)","url":"https://doi.org/10.1200/JCO.21.01436"},{"label":"Molecular selection of therapy in metastatic colorectal cancer: the FOCUS4 molecularly stratified RCT, Efficacy and Mechanism Evaluation 2022","url":"https://doi.org/10.3310/HTNB6908"},{"label":"Experiences of running a stratified medicine adaptive platform trial: challenges and lessons learned from 10 years of the FOCUS4 trial, Clinical Trials 2022","url":"https://doi.org/10.1177/17407745211069879"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["cgp","histopathology-ihc"],"targets":[],"drugs":["adavosertib","capecitabine"],"companies":["mrc-ctu"],"institutions":["uclh","cruk","oxford-cancer"],"pathways":[],"terms":["master-protocol","seamless-adaptive","basket-umbrella-platform","interim-analysis"],"trials":[],"people":["tim-maughan","matt-seymour"],"bottlenecks":["b-trial-design"],"keyPapers":["paper-brown-clin-trials","paper-seligmann-j-clin-oncol","paper-adams-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN90061546","phase":"platform","setting":"Metastatic colorectal cancer stable or responding after 16 weeks of first-line chemotherapy: tumours stratified by biomarker into parallel randomised maintenance comparisons against active monitoring or placebo","sponsor":"MRC Clinical Trials Unit at UCL, funded by the Medical Research Council, the NIHR Efficacy and Mechanism Evaluation programme and Cancer Research UK","result":"FOCUS4-C: adavosertib improved progression-free survival in RAS and TP53 co-mutated tumours (hazard ratio 0.35). FOCUS4-N: maintenance capecitabine improved progression-free survival (hazard ratio 0.40) without an overall survival gain. FOCUS4-D: no benefit from AZD8931.","yearReported":2021,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival, FOCUS4-C (RAS and TP53 mutant)","primary":true,"arms":[{"name":"Adavosertib"},{"name":"Active monitoring"}],"hr":0.35,"source":"https://doi.org/10.1200/JCO.21.01435"},{"endpoint":"Progression-free survival, FOCUS4-N","primary":true,"arms":[{"name":"Maintenance capecitabine"},{"name":"Active monitoring"}],"hr":0.4,"source":"https://doi.org/10.1200/JCO.21.01436"}]},{"id":"foenix-cca2","kind":"trial","name":"FOENIX-CCA2","aka":[],"tldr":"Futibatinib produced responses in over 40% of patients whose bile duct cancer carried an FGFR2 fusion.","summary":"FOENIX-CCA2, trial NCT02052778 sponsored by Taiho and reported in 2022 with publication in the New England Journal of Medicine in 2023, showed that futibatinib produced responses in more than forty percent of patients whose previously treated intrahepatic cholangiocarcinoma carried an FGFR2 rearrangement. It was a single-arm phase 2 of 103 patients with an objective response rate of 42 percent and durable disease control, supporting approval. OnCo links it to biliary tract cancer, FGFR2 as a target, futibatinib and Lipika Goyal. As with pemigatinib, the absence of a randomised comparison leaves open whether an irreversible FGFR inhibitor improves survival over chemotherapy and how it should be sequenced with other FGFR drugs.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02052778","url":"https://clinicaltrials.gov/study/NCT02052778"},{"label":"NEJM 2023","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2206834"}],"tags":[],"related":[],"cancers":["cholangiocarcinoma","intrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["fgfr2"],"drugs":["futibatinib"],"companies":["taiho"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["lipika-goyal"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02052778","phase":"1/2","setting":"Previously treated FGFR2-rearranged intrahepatic cholangiocarcinoma: futibatinib single arm","sponsor":"Taiho","result":"ORR 42%; PFS 9.0 months; OS 21.7 months.","started":"2014-07-21","startedType":"actual","yearReported":2022,"enrolled":103,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Futibatinib","n":103,"value":42}],"source":"https://doi.org/10.1056/NEJMoa2206834"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Futibatinib","value":9}],"source":"https://doi.org/10.1056/NEJMoa2206834"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Futibatinib","value":21.7}],"source":"https://doi.org/10.1056/NEJMoa2206834"}]},{"id":"nct05919264","kind":"trial","name":"FOG-001 in Locally Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of FLOT, CAPOX, Nivolumab in colorectal cancer and metastatic cancer, run by Parabilis Medicines, Inc., now recruiting.","summary":"FOG-001 in Locally Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05919264 by Parabilis Medicines, Inc., with 619 participants planned, started 2023-05-23 and due to reach its primary completion in 2027-04-01. Interventions recorded: FOG-001, mFOLFOX-6, Nivolumab, Trifluridine/tipiracil, Bevacizumab. Conditions listed: Cancer, Colorectal Cancer, Solid Tumor, Locally Advanced Solid Tumor. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05919264","url":"https://clinicaltrials.gov/study/NCT05919264"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","metastatic-cancer","prostate","craniopharyngioma"],"sections":[],"technologies":[],"targets":[],"drugs":["flot","capox","nivolumab","trifluridine-tipiracil","bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05919264","phase":"1/2","setting":"A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors","sponsor":"Parabilis Medicines, Inc.","started":"2023-05-23","startedType":"actual","enrolled":619,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07446322","kind":"trial","name":"FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of Bevacizumab, FOLFIRI in colorectal cancer, run by Oncolytics Biotech, now recruiting.","summary":"FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer is a phase 2 interventional study registered as NCT07446322 by Oncolytics Biotech, with 60 participants planned, started 2026-04-30 and due to reach its primary completion in 2027-08-30. Interventions recorded: Bevacizumab, FOLFIRI, Pelareorep. Conditions listed: Ras-mutated Metastatic Colorectal Cancer, mCRC, MSS Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07446322","url":"https://clinicaltrials.gov/study/NCT07446322"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["bevacizumab","folfiri"],"companies":["oncolytics-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07446322","phase":"2","setting":"An Open-Label, Randomized, Multicentre, Phase 2 Study of FOLFIRI + Bevacizumab + Pelareorep vs. FOLFIRI + Bevacizumab for the Second-Line Treatment of Metastatic, RAS-mutated, Microsatellite-Stable (MSS) Colorectal Cancer","sponsor":"Oncolytics Biotech","started":"2026-04-30","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07729605","kind":"trial","name":"FOLFIRI Plus Bevacizuamb and QL1706 in Second-Line Treatment for mCRC","aka":["FIRBIT"],"tldr":"A phase 3 trial in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"FOLFIRI Plus Bevacizuamb and QL1706 in Second-Line Treatment for mCRC is a phase 3, randomised interventional study registered as NCT07729605 by Sun Yat-sen University, with a registry enrolment figure of 270 participants, started 2026-07-30 and due to reach its primary completion in 2028-12-30. Interventions recorded: FOLFIRI + bevacizumab + QL1706; FOLFIRI + bevacizumab. Conditions listed: Colorectal Cancer Metastatic; Microsatellite Stable (MSS) Colorectal Cancer (CRC). Primary outcome: Progression-free survival (PFS). Colorectal eligibility wording from the registry: \"Histologically confirmed metastatic colorectal adenocarcinoma with pMMR/MSS status\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07729605","url":"https://clinicaltrials.gov/study/NCT07729605"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07729605","phase":"3","setting":"FOLFIRI Plus Bevacizuamb With or Without Iparomlimab and Tuvonralimab as Second-Line Treatment for Metastatic Colorectal Cancer: A Randomized Controlled Trial","sponsor":"Sun Yat-sen University","started":"2026-07-30","startedType":"estimated","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05466799","kind":"trial","name":"FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma","aka":["TRIPP-FFX"],"tldr":"A phase 2 trial of FOLFIRINOX chemotherapy in pancreatic ductal adenocarcinoma, run by OncoSil Medical Limited, active and no longer recruiting.","summary":"FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma is a phase 2 interventional study registered as NCT05466799 by OncoSil Medical Limited, with 88 participants enrolled, started 2023-04-26 and due to reach its primary completion in 2026-01-26. Interventions recorded: FOLFIRINOX chemotherapy and OncoSil™.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05466799","url":"https://clinicaltrials.gov/study/NCT05466799"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05466799","phase":"2","setting":"An Open-label, Multi-centre, Randomized Study of TaRgeted Intratumoural Placement of P-32 (OncoSil™) in Addition to FOLFIRINOX Chemotherapy vs FOLFIRINOX Alone in Patients With Unresectable Locally Advanced Pancreatic Adenocarcinoma.","sponsor":"OncoSil Medical Limited","started":"2023-04-26","startedType":"actual","enrolled":88,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02572141","kind":"trial","name":"FOLFOX or CAPOX Perioperative Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Colon Cancer (OPTICAL)","aka":["OPTICAL"],"tldr":"A phase 3 trial in colorectal cancer, run by Sun Yat-sen University, active but no longer recruiting.","summary":"FOLFOX or CAPOX Perioperative Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Colon Cancer (OPTICAL) is a phase 3, randomised interventional study registered as NCT02572141 by Sun Yat-sen University, with a registry enrolment figure of 738 participants, started 2015-01-01 and due to reach its primary completion in 2023-03-15. Interventions recorded: Perioperative chemotherapy with mFOLFOX6 or CAPOX regimens; Postoperative chemotherapy with mFOLFOX6 or CAPOX regimens. Conditions listed: Colon Cancer. Primary outcome: Disease-free survival. Colorectal eligibility wording from the registry: \"Histological or cytological documentation of adenocarcinoma of the colon (≥ 15 cm from the anal verge)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02572141","url":"https://clinicaltrials.gov/study/NCT02572141"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02572141","phase":"3","setting":"A Phase III Study to Evaluate the 3-year Disease-free Survival in Patients With Locally Advanced Colon Cancer Receiving Either Perioperative or Postoperative Chemotherapy With FOLFOX or CAPOX Regimens","sponsor":"Sun Yat-sen University","started":"2015-01-01","startedType":"actual","enrolled":738,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05727163","kind":"trial","name":"FOLFOX Via HAI Plus Intravenous Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Initially Unresectable RAS-mutat","aka":[],"tldr":"A phase 2 trial of dexamethasone, fOLFOX (5-FU, leucovorin, oxaliplatin), fluorouracil (5-FU), fOLFIRI (5-FU, leucovorin, irinotecan) and other drugs in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"FOLFOX Via HAI Plus Intravenous Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Initially Unresectable RAS-mutated CRLM Patients is a phase 2, randomised interventional study registered as NCT05727163 by Sun Yat-sen University, with a registry enrolment figure of 194 participants, started 2022-07-29 and due to reach its primary completion in 2026-12-31. Interventions recorded: Dexamethasone; Anisodamine; Oxaliplatin; Leucovorin; Fluorouracil; Irinotecan; Bevacizumab; Oxaliplatin; Leucovorin; Fluorouracil. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Objective Remission Rate (ORR). Colorectal eligibility wording from the registry: \"Histologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05727163","url":"https://clinicaltrials.gov/study/NCT05727163"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["dexamethasone","folfox","fluorouracil","folfiri","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05727163","phase":"2","setting":"FOLFOX Via Hepatic Artery Infusion Chemotherapy (HAI) Plus Systemic Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Patients With Initially Unresectable RAS-mutated Colorectal Cancer With Liver Metastases: A Prospective, Randomized, Controlled Clinical Study","sponsor":"Sun Yat-sen University","started":"2022-07-29","startedType":"actual","enrolled":194,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06780787","kind":"trial","name":"FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery","aka":[],"tldr":"A phase 2 trial of balstilimab, botensilimab, capecitabine, fluorouracil (5-FU) and other drugs in colorectal cancer, run by City of Hope Medical Center, now recruiting.","summary":"FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery is a phase 2, interventional study registered as NCT06780787 by City of Hope Medical Center, with a registry enrolment figure of 26 participants, started 2025-05-20 and due to reach its primary completion in 2027-11-05. Interventions recorded: Balstilimab; Biospecimen Collection; Botensilimab; Capecitabine; Computed Tomography; Digital Rectal Examination; Endoscopic Biopsy; Fluorouracil; Leucovorin Calcium; Magnetic Resonance Imaging; Oxaliplatin; Radiation Therapy; Sigmoidoscopy. Conditions listed: Rectal Adenocarcinoma; Stage IIA Rectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8. Primary outcome: Complete clinical response (cCR) rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed adenocarcinoma of the rectum\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06780787","url":"https://clinicaltrials.gov/study/NCT06780787"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["balstilimab","botensilimab","capecitabine","fluorouracil","leucovorin","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06780787","phase":"2","setting":"Phase II Clinical Trial of FOLFOX, Botensilimab, Plus Balstilimab in Patients With Localized Rectal Cancer","sponsor":"City of Hope Medical Center","started":"2025-05-20","startedType":"actual","enrolled":26,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07621497","kind":"trial","name":"FOLFOX8 Versus mFOLFOX6 With Bevacizumab or Cetuximab for First-Line Unresectable Metastatic Colorectal Cancer (Phase II)","aka":[],"tldr":"A phase 2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin), fluorouracil (5-FU), leucovorin (folinic acid), bevacizumab (glioblastoma use) and other drugs in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"FOLFOX8 Versus mFOLFOX6 With Bevacizumab or Cetuximab for First-Line Unresectable Metastatic Colorectal Cancer (Phase II) is a phase 2, randomised interventional study registered as NCT07621497 by Sun Yat-sen University, with a registry enrolment figure of 229 participants, started 2026-06-01 and due to reach its primary completion in 2029-06-01. Interventions recorded: Oxaliplatin; 5-Fluorouracil; Levofolinic Acid For Injection; Calcium Folinate; Bevacizumab; Cetuximab (EGFR inhibitor). Conditions listed: Metastatic Colorectal Cancer (CRC). Primary outcome: Progression-Free Survival（PFS）. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed unresectable metastatic colorectal cancer with no prior treatment for unresectable or metastatic disease\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07621497","url":"https://clinicaltrials.gov/study/NCT07621497"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["folfox","fluorouracil","leucovorin","bevacizumab-glioma","cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07621497","phase":"2","setting":"A Prospective, Multicenter, Randomized Controlled, Phase II Study to Evaluate the Efficacy and Safety of FOLFOX8 Versus mFOLFOX6 Combined With Bevacizumab or Cetuximab as First-Line Treatment for Unresectable Metastatic Colorectal Cancer","sponsor":"Sun Yat-sen University","started":"2026-06-01","startedType":"estimated","enrolled":229,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06733038","kind":"trial","name":"FOLFOXIRI Plus Bevacizumab With or Without Atezolizumab as 1st Line Treatment of pMMR and IS IC-High Metastatic Colorectal Cancer Patients.","aka":["AtezoTRIBE2"],"tldr":"A phase 3 trial of atezolizumab, bevacizumab (glioblastoma use), fOLFIRI (5-FU, leucovorin, irinotecan), fOLFOX (5-FU, leucovorin, oxaliplatin) and other drugs in colorectal cancer, run by Gruppo Oncologico del Nord-Ovest, now recruiting.","summary":"FOLFOXIRI Plus Bevacizumab With or Without Atezolizumab as 1st Line Treatment of pMMR and IS IC-High Metastatic Colorectal Cancer Patients. is a phase 3, randomised interventional study registered as NCT06733038 by Gruppo Oncologico del Nord-Ovest, with a registry enrolment figure of 238 participants, started 2024-11-15 and due to reach its primary completion in 2028-04-01. Interventions recorded: Atezolizumab; Bevacizumab; Irinotecan (CPT-11); Oxaliplatin; Leucovorin; Fluorouracil (5-FU). Conditions listed: Colorectal Cancer. Primary outcome: Progression Free Survival (PFS). Colorectal eligibility wording from the registry: \"* Histologically proven diagnosis of colorectal cancer;\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06733038","url":"https://clinicaltrials.gov/study/NCT06733038"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["atezolizumab","bevacizumab-glioma","folfiri","folfox","fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06733038","phase":"3","setting":"Phase III Randomized Study of FOLFOXIRI Plus Bevacizumab and Atezolizumab Versus FOLFOXIRI Plus Bevacizumab as First-Line Treatment of Unresectable pMMR and Immunoscore IC-High Metastatic Colorectal Cancer Patients","sponsor":"Gruppo Oncologico del Nord-Ovest","started":"2024-11-15","startedType":"actual","enrolled":238,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07558083","kind":"trial","name":"FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients","aka":["FOLICOLOR"],"tldr":"A phase 3 trial in colorectal cancer, run by University Hospital, Antwerp, now recruiting.","summary":"FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients is a phase 3, randomised interventional study registered as NCT07558083 by University Hospital, Antwerp, with a registry enrolment figure of 150 participants, started 2021-08-16 and due to reach its primary completion in 2029-12. Interventions recorded: Evaluation therapy through Liquid Biopsy. Conditions listed: Advanced Colorectal Cancer. Primary outcome: Time to Deterioration (TTD) in Quality of Life (QoL). Colorectal eligibility wording from the registry: \"* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in subjects with unresectable metastatic (M1) disease\". Sites: Belgium. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07558083","url":"https://clinicaltrials.gov/study/NCT07558083"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07558083","phase":"3","setting":"FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients","sponsor":"University Hospital, Antwerp","started":"2021-08-16","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"fort","kind":"trial","name":"FoRT","aka":["FORT","FoRT trial"],"tldr":"FoRT asked whether two very small doses of radiotherapy control follicular lymphoma as well as the standard twelve; they do not, with about three times the rate of regrowth in the treated area, so 24 Gy stays the standard when the aim is lasting control and 4 Gy is kept for palliation.","summary":"FoRT was a UK phase 3 non-inferiority trial that randomised 614 target sites in 548 patients with follicular or marginal zone lymphoma to 24 Gy in 12 fractions or 4 Gy in 2 fractions. The primary endpoint was time to local progression within the irradiated volume; the trial allowed both curative-intent and palliative treatment.\n\nAt the first report 4 Gy failed non-inferiority, with a hazard ratio of 3.42 for local progression. Long-term follow-up at a median of 73.8 months confirmed the difference: local progression-free rates were 94.1 percent at two years and 89.9 percent at five years after 24 Gy against 79.8 and 70.4 percent after 4 Gy. The corpus's follicular lymphoma page names involved-site radiotherapy of 24 Gy for localised disease on this evidence, while 4 Gy remains a useful palliative option.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00310167","url":"https://clinicaltrials.gov/study/NCT00310167"}],"tags":["soc-trials"],"related":[],"cancers":["follicular-lymphoma","marginal-zone-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["hypofractionated-radiotherapy","palliative-radiotherapy"],"targets":[],"drugs":[],"companies":[],"institutions":["uclh"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-fort-4gy-vs-24gy-indolent-lymphoma-hoskin-lancet-oncol-2014","paper-fort-long-term-follow-up-hoskin-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00310167","phase":"3","setting":"Follicular or marginal zone lymphoma needing local radiotherapy for cure or palliation, in 43 UK centres: 24 Gy in 12 fractions against 4 Gy in 2 fractions to the same site, with time to local progression in the irradiated field as the primary endpoint (non-inferiority)","sponsor":"University College, London","result":"4 Gy was not non-inferior to 24 Gy for local control: five-year local progression-free rate 89.9 percent after 24 Gy against 70.4 percent after 4 Gy (hazard ratio 3.46).","started":"2005-10","yearReported":2014,"enrolled":548,"enrolledBasis":"randomised","enrolledNote":"The registry counts 614, the number of randomised target sites; the trial randomised 548 patients (some with more than one site) between 2006 and 2011.","outcomes":[{"endpoint":"Local progression-free rate at 5 years in the irradiated site","primary":true,"unit":"%","arms":[{"name":"24 Gy in 12 fractions","n":299,"value":89.9,"note":"95% CI 85.5 to 93.1; 299 sites randomised"},{"name":"4 Gy in 2 fractions","n":315,"value":70.4,"note":"95% CI 64.7 to 75.4; 315 sites randomised"}],"hr":3.46,"ci":[2.25,5.33],"source":"https://doi.org/10.1016/S1470-2045(20)30686-0"},{"endpoint":"Local progression-free rate at 2 years in the irradiated site","unit":"%","arms":[{"name":"24 Gy in 12 fractions","n":299,"value":94.1,"note":"95% CI 90.6 to 96.4"},{"name":"4 Gy in 2 fractions","n":315,"value":79.8,"note":"95% CI 74.8 to 83.9"}],"source":"https://doi.org/10.1016/S1470-2045(20)30686-0"},{"endpoint":"Time to local progression, first analysis (hazard for 4 Gy against 24 Gy)","arms":[{"name":"4 Gy in 2 fractions","note":"70 local progressions"},{"name":"24 Gy in 12 fractions","note":"21 local progressions; median follow-up 26 months"}],"hr":3.42,"ci":[2.09,5.55],"source":"https://doi.org/10.1016/S1470-2045(14)70036-1"}]},{"id":"fortifi-hn01","kind":"trial","name":"FORTIFI-HN01","aka":[],"tldr":"A bifunctional antibody that blocks EGFR and soaks up TGF-beta, aiming to make HPV-negative head and neck tumours respond to immunotherapy.","summary":"FORTIFI-HN01, trial NCT06788990 sponsored by Bicara Therapeutics, tests ficerafusp alfa, a bifunctional antibody that blocks EGFR and soaks up TGF-beta, with pembrolizumab against pembrolizumab alone in untreated PD-L1-positive, HPV-negative recurrent or metastatic head and neck cancer. Two-year phase 1/1b data published in JCO in 2025 reported durable responses in HPV-negative disease, the phase 3 dose is fixed at 1500 mg, and Bicara expects substantial enrolment by the end of 2026 with an interim analysis in mid-2027; unlike LiGeR-HN1 it excludes HPV-positive oropharyngeal cancer. OnCo links it to head and neck cancer, bispecific antibodies, EGFR as a target, ficerafusp alfa, pembrolizumab and the pairing of an EGFR-directed bispecific with PD-1 blockade. Whether trapping TGF-beta makes cold HPV-negative tumours respond to immunotherapy is the question it will answer.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06788990","url":"https://clinicaltrials.gov/study/NCT06788990"},{"label":"Phase 1/1b two-year results, JCO 2025","url":"https://ascopubs.org/doi/10.1200/JCO-25-02027"}],"tags":[],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc","hpv-negative-head-and-neck-cancer"],"sections":[],"technologies":["bispecific-antibody"],"targets":["egfr"],"drugs":["ficerafusp-alfa","pembrolizumab"],"companies":["bicara-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06788990","phase":"2/3","setting":"Untreated PD-L1-positive, HPV-negative recurrent or metastatic HNSCC: ficerafusp alfa + pembrolizumab vs pembrolizumab","sponsor":"Bicara Therapeutics","started":"2025-01-28","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"fortitude-101","kind":"trial","name":"FORTITUDE-101","aka":[],"tldr":"A new target, FGFR2b, showed a survival gain at first look that shrank with longer follow-up, and the trial did not include the immunotherapy patients now routinely get.","summary":"Interim analysis: OS 17.9 vs 12.5 months (HR 0.61, p=0.005). Updated analysis (ESMO 2025) showed the difference attenuate and lose significance. The chemotherapy-only control (no PD-1) and ocular toxicity (corneal events in most patients) limit interpretation. FORTITUDE-102 tests the combination with nivolumab.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05052801","url":"https://clinicaltrials.gov/study/NCT05052801"},{"label":"ESMO 2025 LBA10","url":"https://www.annalsofoncology.org/article/S0923-7534(25)04862-8/fulltext"}],"tags":[],"related":[],"cancers":["gastric"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["fgfr2"],"drugs":["bemarituzumab","folfox"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["zev-wainberg"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05052801","phase":"3","setting":"First-line FGFR2b-overexpressing (≥10% 2+/3+), HER2-negative advanced gastric/GEJ cancer: bemarituzumab + mFOLFOX6 vs placebo + mFOLFOX6","sponsor":"Amgen","result":"Interim OS 17.9 vs 12.5 months (HR 0.61); benefit attenuated on follow-up.","started":"2022-03-07","startedType":"actual","yearReported":2025,"enrolled":547,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (interim)","primary":true,"unit":"months","arms":[{"name":"Bemarituzumab + mFOLFOX6","value":17.9},{"name":"Placebo + mFOLFOX6","value":12.5}],"hr":0.61,"p":"0.005","source":"https://www.annalsofoncology.org/article/S0923-7534(25)04862-8/fulltext"}],"replication":"Phase 2 FIGHT showed a similar early signal; no confirmatory trial yet."},{"id":"fortplus","kind":"trial","name":"FORTplus","aka":["FORTplus trial","Early Stage Follicular Lymphoma and Radiotherapy plus Anti-CD20 Antibody"],"tldr":"A trial testing whether a radiotherapy dose one sixth of the standard works as well for early follicular lymphoma when an antibody is given alongside it.","summary":"Two pieces of evidence pull in opposite directions here. The FoRT trial found 4 Gy of radiotherapy inferior to 24 Gy for indolent lymphoma on response and progression-free survival. The MIR study and TROG 99.03 found that adding an anti-CD20 antibody to localised radiotherapy improves outcomes, and the GAZAI study reported a high complete response rate with 2 by 2 Gy combined with obinutuzumab.\n\nFORTplus tests whether the antibody makes the low dose safe. Its first question is the non-inferiority of 4 Gy given with an anti-CD20 antibody; if that holds, its second is whether obinutuzumab with low-dose radiotherapy is superior to rituximab with the standard dose, tested on the same set. The primary endpoint is morphological complete response, with primary completion estimated for 30 September 2027 at German sites.\n\nThe prize the trial is playing for is explicit in its protocol: a radiation dose reduced to 16 per cent of the standard, which would change how early follicular lymphoma is treated everywhere, including in settings where radiotherapy capacity is the binding constraint.","status":"active","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT05045664","url":"https://clinicaltrials.gov/study/NCT05045664"},{"label":"FoRT long-term follow-up, Lancet Oncology 2021","url":"https://doi.org/10.1016/S1470-2045(20)30686-0"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["follicular-lymphoma","non-hodgkin-lymphoma"],"sections":["radiation","immunotherapy"],"technologies":["radiotherapy","monoclonal-antibody"],"targets":["cd20"],"drugs":["rituximab","obinutuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":["complete-response","non-inferiority"],"trials":["trog-99-03"],"people":[],"bottlenecks":["b-surgery-radiation-innovation","b-global-access","b-toxicity-qol"],"keyPapers":["paper-fort-4gy-vs-24gy-indolent-lymphoma-hoskin-lancet-oncol-2014","paper-fort-long-term-follow-up-hoskin-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05045664","phase":"3","setting":"Early-stage follicular lymphoma: low-dose radiotherapy of 4 Gy with an anti-CD20 antibody against standard-dose radiotherapy with rituximab, and obinutuzumab against rituximab","sponsor":"Heidelberg University","started":"2022-07-06","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01086488","kind":"trial","name":"Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Nasopharyngeal Carcinoma","aka":[],"tldr":"A phase 2 trial of Temoporfin in Nasopharyngeal carcinoma, run by Ministry of Health, Malaysia, with a status the registry has not verified recently.","summary":"Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Nasopharyngeal Carcinoma is a phase 2 interventional study registered as NCT01086488 by Ministry of Health, Malaysia, with 66 participants planned, started 2009-01 and due to reach its primary completion in 2011-09. Interventions recorded: FOSCAN. Conditions recorded: Nasopharyngeal Carcinoma.\n\nLinked to the drug Temoporfin because the registry names it among its interventions and Nasopharyngeal carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01086488","url":"https://clinicaltrials.gov/study/NCT01086488"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nasopharyngeal","recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["temoporfin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01086488","phase":"2","setting":"A Phase II, Randomized Controlled Trial of Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Recurrent or Persistent Nasopharyngeal Carcinoma","sponsor":"Ministry of Health, Malaysia","started":"2009-01","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04543279","kind":"trial","name":"Fostamatinib as a Single Agent or in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis With Severe Thrombocytopenia","aka":[],"tldr":"A phase 2 trial of Fostamatinib and Ruxolitinib in Primary myelofibrosis, run by Washington University School of Medicine, recorded as terminated on the registry.","summary":"Fostamatinib as a Single Agent or in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis With Severe Thrombocytopenia is a phase 2 interventional study registered as NCT04543279 by Washington University School of Medicine, with 3 participants recorded, started 2021-05-03 and due to reach its primary completion in 2022-07-01. Interventions recorded: Fostamatinib, Ruxolitinib. Conditions recorded: Myelofibrosis, Thrombocytopenia.\n\nLinked to the drug Fostamatinib because the registry names it among its interventions and Primary myelofibrosis among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04543279","url":"https://clinicaltrials.gov/study/NCT04543279"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["primary-myelofibrosis"],"sections":[],"technologies":[],"targets":[],"drugs":["fostamatinib","ruxolitinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04543279","phase":"2","setting":"Fostamatinib as a Single Agent or in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis With Severe Thrombocytopenia","sponsor":"Washington University School of Medicine","started":"2021-05-03","startedType":"actual","yearReported":2023,"enrolled":3,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With a Platelet Response (Part A)","primary":true,"unit":"participants","arms":[{"name":"Part A: Fostamatinib","n":3,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-12-15), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04543279?tab=results"}]},{"id":"fourlight-1","kind":"trial","name":"FOURLIGHT-1","aka":[],"tldr":"In FOURLIGHT-1, a CDK4-only inhibitor designed to avoid the low blood counts of current CDK4/6 drugs improved progression-free survival in second line.","summary":"FOURLIGHT-1, trial NCT06105632 sponsored by Pfizer and reported in early 2026, showed in a randomised phase 2 that atirmociclib, a CDK4-only inhibitor designed to avoid the low blood counts of current CDK4/6 drugs, improves progression-free survival when added to fulvestrant after progression on a CDK4/6 inhibitor in HR-positive, HER2-negative advanced breast cancer. The trial, which enrolled 333 patients according to ClinicalTrials.gov, met its primary endpoint in topline results on 17 March 2026 with lower neutropenia than dual CDK4/6 inhibitors, and the phase 3 FOURLIGHT-3 trial in the first line is enrolling. OnCo links it to CDK4/6 as a target, atirmociclib and the idea of CDK4-selective inhibitors as the new first-line backbone. It is the first randomised evidence that a selective CDK4 inhibitor works after CDK4/6 progression, and whether that holds in the first-line phase 3 is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06105632","url":"https://clinicaltrials.gov/study/NCT06105632"},{"label":"Pfizer release","url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-topline-phase-2-results-next"}],"tags":[],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":["cdk4-6"],"drugs":["atirmociclib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06105632","phase":"2","setting":"HR+/HER2- advanced breast cancer after CDK4/6 inhibitor: atirmociclib + fulvestrant vs fulvestrant","sponsor":"Pfizer","result":"PFS improved (HR not yet published in detail).","started":"2024-01-09","startedType":"actual","yearReported":2026,"enrolled":333,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (investigator-assessed)","primary":true,"unit":"months","arms":[{"name":"Atirmociclib + fulvestrant","note":"Randomised phase 2, post-CDK4/6 inhibitor; medians pending presentation (topline 17 March 2026)"},{"name":"Fulvestrant, or everolimus + exemestane"}],"hr":0.6,"ci":[0.44,0.825],"p":"0.0007","source":"https://www.cancernetwork.com/view/atirmociclib-fulvestrant-improves-pfs-in-hr-her2-breast-cancer"}],"replication":"First randomised evidence that a selective CDK4 inhibitor works after CDK4/6 progression; the first-line phase 3 programme will be the confirmatory test."},{"id":"foxtrot","kind":"trial","name":"FOxTROT","aka":["Fluoropyrimidine, Oxaliplatin and Targeted Receptor pre-Operative Therapy","ISRCTN83842641"],"tldr":"The UK trial that showed giving some chemotherapy before the operation for colon cancer shrinks the tumour, leaves cleaner margins and cuts the chance of the cancer coming back.","summary":"FOxTROT allocated people with locally advanced but operable colon cancer 2:1 to six weeks of preoperative oxaliplatin and fluoropyrimidine chemotherapy or to the standard 24 weeks after surgery. Nearly all who started finished: 674 of 699 began the preoperative course and 606 completed it. Serious postoperative complications were fewer, not more. Resection was histopathologically complete in 94 percent against 89 percent (p < 0.001), and residual or recurrent disease within two years fell from 21.5 percent to 16.9 percent (rate ratio 0.72, 0.54 to 0.98, p = 0.037). Panitumumab added nothing, and mismatch repair deficient tumours gained little. The platform continues as FOxTROT 2 and 3 with the University of Leeds as sponsor, recruiting at 77 centres from Leeds and Glasgow to Velindre and Bangor.","status":"positive","asOf":"2026-09-24","links":[{"label":"Journal of Clinical Oncology 2023","url":"https://europepmc.org/article/MED/36657089"},{"label":"Annals of Oncology 2025: the extended biomarker analysis","url":"https://europepmc.org/article/MED/39805350"},{"label":"ISRCTN83842641","url":"https://www.isrctn.com/ISRCTN83842641"}],"tags":["uk","neoadjuvant","colorectal","platform"],"related":[],"cancers":["colorectal","colon-cancer"],"sections":["chemotherapy","surgery"],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","capox","oxaliplatin","panitumumab","fluorouracil"],"companies":[],"institutions":["birmingham-cancer-centre","leeds-cancer-centre"],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":["niche-2"],"people":["dion-morton","matt-seymour"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN83842641","phase":"3","setting":"Six weeks of preoperative oxaliplatin-fluoropyrimidine chemotherapy plus 18 weeks after surgery, against 24 weeks after surgery alone, in radiologically staged T3-4 N0-2 M0 colon cancer, with a second randomisation to panitumumab in RAS wild-type tumours; the platform continues as FOxTROT 2 and 3 across 77 centres to April 2027","sponsor":"University of Birmingham (original trial); University of Leeds (continuing platform)","result":"Residual or recurrent disease within two years 16.9 percent with six weeks of preoperative chemotherapy against 21.5 percent with postoperative chemotherapy alone (rate ratio 0.72, 0.54 to 0.98, p = 0.037); complete resection 94 percent against 89 percent.","yearReported":2023,"enrolled":1053,"enrolledBasis":"randomised","enrolledNote":"699 patients were allocated to neoadjuvant chemotherapy and 354 to control, 1,053 in total, in the Journal of Clinical Oncology 2023 report; the continuing platform record ISRCTN83842641 carries a target of 1,703.","outcomes":[{"endpoint":"Residual or recurrent disease within 2 years","primary":true,"unit":"percent","arms":[{"name":"Neoadjuvant chemotherapy","n":699,"value":16.9},{"name":"Surgery first","n":354,"value":21.5}],"p":"0.037","source":"https://europepmc.org/article/MED/36657089"}]},{"id":"nct06909825","kind":"trial","name":"FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","aka":[],"tldr":"A phase 2 trial of FPI-2265, Olaparib in prostate cancer, run by Fusion Pharmaceuticals Inc., active and no longer recruiting.","summary":"FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) is a phase 2 interventional study registered as NCT06909825 by Fusion Pharmaceuticals Inc., with 85 participants planned, started 2025-02-26 and due to reach its primary completion in 2027-05. Interventions recorded: FPI-2265, Olaparib. Conditions listed: Metastatic Castration-resistant Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06909825","url":"https://clinicaltrials.gov/study/NCT06909825"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["fpi-2265","olaparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06909825","phase":"2","setting":"A Phase 2, Open-label, Multi-centre Study of FPI-2265 (225Ac-PSMA-I&T) and Olaparib in Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)","sponsor":"Fusion Pharmaceuticals Inc.","started":"2025-02-26","startedType":"actual","enrolled":85,"enrolledBasis":"registry","outcomes":[]},{"id":"fresco","kind":"trial","name":"FRESCO","aka":[],"tldr":"The Chinese trial that first showed fruquintinib works. FRESCO-2 then repeated it worldwide in patients who had already had everything.","summary":"FRESCO randomised 416 patients at 28 Chinese hospitals 2:1 to fruquintinib 5 mg daily, three weeks on and one off, or placebo after at least two lines of chemotherapy, excluding patients who had already had a VEGFR inhibitor. Median overall survival was 9.3 against 6.6 months (hazard ratio 0.65, 95% CI 0.51 to 0.83). Fruquintinib was approved in China in 2018 on this trial. FRESCO-2 then tested it in a heavily pretreated global population who had progressed on or could not tolerate trifluridine/tipiracil or regorafenib, reaching 7.4 against 4.8 months, and led to the FDA approval on 8 November 2023, the EU marketing authorisation for Fruzaqla on 20 June 2024 and NICE TA1079 in July 2025.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02314819","url":"https://clinicaltrials.gov/study/NCT02314819"},{"label":"FRESCO: fruquintinib versus placebo in previously treated metastatic colorectal cancer (JAMA 2018)","url":"https://doi.org/10.1001/jama.2018.7855"},{"label":"EMA Fruzaqla","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqla"},{"label":"NICE TA1079: fruquintinib for previously treated metastatic colorectal cancer","url":"https://www.nice.org.uk/guidance/ta1079"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["kinase-inhibitors","antiangiogenic"],"targets":["vegf"],"drugs":["fruquintinib"],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":["fresco-2"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02314819","phase":"3","setting":"Chinese patients with metastatic colorectal cancer progressing after at least two lines of chemotherapy and no previous VEGFR inhibitor: fruquintinib against placebo","sponsor":"Hutchison Medipharma","result":"Median overall survival 9.3 against 6.6 months (hazard ratio 0.65).","started":"2014-12","yearReported":2018,"enrolled":416,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Fruquintinib","n":278,"value":9.3},{"name":"Placebo","n":138,"value":6.6}],"hr":0.65,"ci":[0.51,0.83],"source":"https://doi.org/10.1001/jama.2018.7855"}],"replication":"FRESCO-2 replicated the effect internationally in a more heavily pretreated population."},{"id":"fresco-2","kind":"trial","name":"FRESCO-2","aka":[],"tldr":"A selective VEGF-receptor pill gave a modest but real survival gain in patients with no remaining standard treatment.","summary":"FRESCO-2, trial NCT04322539 sponsored by Hutchmed and Takeda and published in the Lancet in 2023, showed that the selective VEGF receptor tablet fruquintinib gives a modest but real survival gain in metastatic colorectal cancer patients with no remaining standard treatment. It randomised 691 patients after all standard therapies to fruquintinib or placebo, met its primary overall survival endpoint and led to FDA approval in November 2023, with hypertension and hand-foot syndrome the main toxicities and better tolerability than regorafenib. OnCo links it to colorectal cancer, VEGF as a target, fruquintinib, Jin Li and Tae Won Kim, and it replicates the Chinese FRESCO trial. How fruquintinib should be ordered against trifluridine and tipiracil plus bevacizumab is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04322539","url":"https://clinicaltrials.gov/study/NCT04322539"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":["vegf"],"drugs":["fruquintinib"],"companies":["hutchmed","takeda"],"institutions":[],"pathways":[],"terms":[],"trials":["fresco","correct","concur"],"people":["li-jin-fuscc","kim-tae-won"],"bottlenecks":[],"keyPapers":["paper-dasari-fresco-2-fruquintinib-lancet-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04322539","phase":"3","setting":"Refractory metastatic colorectal cancer after all standard therapies: fruquintinib vs placebo","sponsor":"HUTCHMED / Takeda","result":"OS 7.4 vs 4.8 months, HR 0.66.","started":"2020-08-12","startedType":"actual","yearReported":2023,"enrolled":691,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Fruquintinib","n":461,"value":7.4},{"name":"Placebo","n":230,"value":4.8}],"hr":0.66,"ci":[0.55,0.8],"source":"https://www.takedaoncology.com/newsroom/news-releases/2023/hutchmed-fresco2-lancet-results/"}],"replication":"Replicates the Chinese FRESCO trial (OS 9.3 vs 6.6 months)."},{"id":"frontmind","kind":"trial","name":"frontMIND","aka":[],"tldr":"The first frontline regimen to beat R-CHOP in high-risk large B-cell lymphoma since rituximab, by adding a CD19 antibody and lenalidomide.","summary":"frontMIND, trial NCT04824092 sponsored by Incyte and MorphoSys and published in the Lancet in 2026, produced the first frontline regimen to beat R-CHOP in high-risk large B-cell lymphoma since rituximab itself, by adding the CD19 antibody tafasitamab and lenalidomide. It randomised 899 patients with IPI 3 to 5 disease to tafasitamab plus lenalidomide with R-CHOP or placebo with R-CHOP and met its primary progression-free survival endpoint at two years after a median follow-up of 35.2 months, with overall survival immature and added haematological toxicity; a supplemental application was planned for the first half of 2026. OnCo links it to lymphoma, tafasitamab, lenalidomide and the IPI term. Whether the progression benefit converts into a survival benefit, and how the regimen compares with Pola-R-CHP, are the open questions.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04824092","url":"https://clinicaltrials.gov/study/NCT04824092"},{"label":"Lancet 2026","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00866-4/fulltext"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["tafasitamab","lenalidomide"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":["ipi-score"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04824092","phase":"3","setting":"Untreated high-risk DLBCL (IPI 3-5): tafasitamab + lenalidomide + R-CHOP vs placebo + R-CHOP","sponsor":"Incyte / MorphoSys","result":"PFS HR 0.75; 2-year PFS 71.1% vs 62.9%.","started":"2021-05-11","startedType":"actual","yearReported":2025,"enrolled":899,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 2 years","primary":true,"unit":"%","arms":[{"name":"Tafa-Len-R-CHOP","n":448,"value":71.1},{"name":"R-CHOP","n":451,"value":62.9}],"hr":0.75,"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00866-4/fulltext"}]},{"id":"nct06484153","kind":"trial","name":"Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma","aka":[],"tldr":"A phase 2 trial of fruquintinib and pembrolizumab in colorectal cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, now recruiting.","summary":"Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma is a phase 2, interventional study registered as NCT06484153 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 25 participants, started 2024-07-22 and due to reach its primary completion in 2026-07-22. Interventions recorded: Pirfenidone; Fruquintinib; Pembrolizumab. Conditions listed: To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma; To Evaluate Whether Pirfenidone Can Reshape the Tumor Microenvironment in Colorectal Cancer; Combination of Fruquintinib and Anti-PD-1 Antibody Was Reported to Improve Patient Prognosis in Colorectal Cancer. Primary outcome: Progression Free Survival (PFS); Occurrence of Grade 4 toxicity; Occurrence of Grade 3 toxicity. Colorectal eligibility wording from the registry: \"Histologically confirmed diagnosis of unresectable locally advanced, recurrent or metastatic colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06484153","url":"https://clinicaltrials.gov/study/NCT06484153"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06484153","phase":"2","setting":"A Randomized Phase 2 Clinical Trial Evaluating Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Patients With Standard Treatment Failure of Advanced or Metastatic pMMR/MSS Colorectal Carcinoma","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2024-07-22","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06356584","kind":"trial","name":"Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Shandong Cancer Hospital and Institute, now recruiting.","summary":"Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases is a phase 2, randomised interventional study registered as NCT06356584 by Shandong Cancer Hospital and Institute, with a registry enrolment figure of 62 participants, started 2024-04-01 and due to reach its primary completion in 2026-10-01. Interventions recorded: Immunotherapy (Sintilimab); Targeted Therapy Agent (Fruquintinib); Radiotherapy (SBRT and LDRT). Conditions listed: Colorectal Cancer; Immunotherapy; Radiotherapy; Targeted Therapy; Liver Metastasis. Primary outcome: Progression-free survival (PFS). Colorectal eligibility wording from the registry: \"* Histologically confirmed colorectal adenocarcinoma with liver metastases (8th edition AJCC)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06356584","url":"https://clinicaltrials.gov/study/NCT06356584"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06356584","phase":"2","setting":"Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases: A Randomized, Controlled, Multicenter Phase II Trial","sponsor":"Shandong Cancer Hospital and Institute","started":"2024-04-01","startedType":"actual","enrolled":62,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07286695","kind":"trial","name":"Fruquintinib Combined With Trifluridine/Tipiracil Versus Bevacizumab Combined With Trifluridine/Tipiracil for Advanced Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, not yet recruiting.","summary":"Fruquintinib Combined With Trifluridine/Tipiracil Versus Bevacizumab Combined With Trifluridine/Tipiracil for Advanced Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07286695 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 292 participants, started 2025-12-31 and due to reach its primary completion in 2029-12-31. Interventions recorded: Fruquintinib Combined With trifluridine/tipiracil; Bevacizumab combined with trifluridine/tipiracil. Conditions listed: Metastatic Colorectal Cancer (CRC); Colorectal Cancer. Primary outcome: Progression-free survival (PFS). Colorectal eligibility wording from the registry: \"* Diagnosed with advanced metastatic colorectal adenocarcinoma by histopathological examination;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07286695","url":"https://clinicaltrials.gov/study/NCT07286695"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07286695","phase":"2","setting":"A Multicenter, Open-label, Randomized Controlled Study of Fruquintinib Combined With Trifluridine/Tipiracil Versus Bevacizumab Combined With Trifluridine/Tipiracil in the Treatment of Patients With Advanced Metastatic Colorectal Cancer Who Failed Standard Chemotherapy","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2025-12-31","startedType":"estimated","enrolled":292,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07510932","kind":"trial","name":"Fruquintinib In Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies in South Korea Patients (FIRST-K)","aka":["FIRST-K"],"tldr":"A phase 2 trial of fruquintinib in colorectal cancer, run by Korea University Anam Hospital, not yet recruiting.","summary":"Fruquintinib In Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies in South Korea Patients (FIRST-K) is a phase 2, interventional study registered as NCT07510932 by Korea University Anam Hospital, with a registry enrolment figure of 88 participants, started 2026-05-01 and due to reach its primary completion in 2027-03-01. Interventions recorded: Fruquintinib. Conditions listed: Colon Cancer. Primary outcome: Progression-free survival. Colorectal eligibility wording from the registry: \"Documented irreversible surgical sterilization, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07510932","url":"https://clinicaltrials.gov/study/NCT07510932"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07510932","phase":"2","setting":"Fruquintinib In Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies in South Korea Patients (FIRST-K)","sponsor":"Korea University Anam Hospital","started":"2026-05-01","startedType":"estimated","enrolled":88,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07724223","kind":"trial","name":"Fruquintinib Plus Anti-EGFR Antibody for Third-Line Treatment of RAS Wild-Type mCRC","aka":[],"tldr":"A phase 2 trial of fruquintinib and cetuximab in colorectal cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"Fruquintinib Plus Anti-EGFR Antibody for Third-Line Treatment of RAS Wild-Type mCRC is a phase 2, interventional study registered as NCT07724223 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 46 participants, started 2026-01-16 and due to reach its primary completion in 2028-10-01. Interventions recorded: Fruquintinib plus Cetuximab-beta. Conditions listed: Metastatic Colorectal Cancer (CRC). Primary outcome: Objective Response Rate (ORR). Colorectal eligibility wording from the registry: \"Histologically confirmed metastatic or advanced colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07724223","url":"https://clinicaltrials.gov/study/NCT07724223"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["fruquintinib","cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07724223","phase":"2","setting":"A Phase II Study of Fruquintinib Combined With Anti-EGFR Monoclonal Antibody in Third-Line Treatment of RAS Wild-Type Metastatic Colorectal Cancer","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2026-01-16","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06423937","kind":"trial","name":"Fruquintinib Plus Camrelizumab and HAIC in the Treatment of Non-MSI-H Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of camrelizumab in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"Fruquintinib Plus Camrelizumab and HAIC in the Treatment of Non-MSI-H Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT06423937 by Fudan University, with a registry enrolment figure of 129 participants, started 2024-05 and due to reach its primary completion in 2026-07. Interventions recorded: combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus Camrelizumab. Conditions listed: Colorectal Cancer. Primary outcome: objective response rate (ORR). Colorectal eligibility wording from the registry: \"* Patients with histologically or cytologically confirmed non-MSI-H ( according to the detection criteria of the institutional testing center, immunohistochemistry, PCR or NGS detection can be used ) unresectable advanced colorectal cancer with liver metastasis ;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06423937","url":"https://clinicaltrials.gov/study/NCT06423937"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["camrelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06423937","phase":"2","setting":"A Single-center, Open-label, Double-cohort Clinical Study of Fruquintinib Plus Camrelizumab Plus HAIC in the Treatment of Non-MSI-H Advanced Colorectal Cancer Patients With Liver Metastasis After the Failure of First-line Treatment","sponsor":"Fudan University","started":"2024-05","startedType":"estimated","enrolled":129,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07362836","kind":"trial","name":"Fruquintinib Versus Bevacizumab Plus Chemotherapy in Second-Line RAS-Mutant Metastatic Colorectal Cancer (FRU-RAS)","aka":[],"tldr":"A phase 3 trial of fruquintinib and bevacizumab (glioblastoma use) in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"Fruquintinib Versus Bevacizumab Plus Chemotherapy in Second-Line RAS-Mutant Metastatic Colorectal Cancer (FRU-RAS) is a phase 3, randomised interventional study registered as NCT07362836 by Fudan University, with a registry enrolment figure of 224 participants, started 2026-01-31 and due to reach its primary completion in 2028-12-30. Interventions recorded: fruquintinib+chemotherapy; bevacizumab+chemotherapy. Conditions listed: Colorectal Cancer. Primary outcome: Progression-Free Survival. Colorectal eligibility wording from the registry: \"Histologically and/or cytologically confirmed unresectable metastatic colorectal cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07362836","url":"https://clinicaltrials.gov/study/NCT07362836"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07362836","phase":"3","setting":"Fruquintinib Versus Bevacizumab Plus Chemotherapy as Second-Line Therapy for Patients With RAS-Mutant Metastatic Colorectal Cancer (FRU-RAS): A Multicenter Randomized Controlled Trial","sponsor":"Fudan University","started":"2026-01-31","startedType":"estimated","enrolled":224,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07051785","kind":"trial","name":"Fruquintinib vs Bevacizumab Combined With Irinotecan Liposome and Capecitabine as Second-Line Therapy for Advanced Metastatic Colorectal Cancer","aka":["ARK"],"tldr":"A phase 2 trial of fruquintinib, capecitabine and bevacizumab (glioblastoma use) in colorectal cancer, run by Liu Huang, not yet recruiting.","summary":"Fruquintinib vs Bevacizumab Combined With Irinotecan Liposome and Capecitabine as Second-Line Therapy for Advanced Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07051785 by Liu Huang, with a registry enrolment figure of 68 participants, started 2025-07-07 and due to reach its primary completion in 2027-07-06. Interventions recorded: Fruquintinib+Irinotecan Liposome+Capecitabine; Bevacizumab+Irinotecan Liposome+Capecitabine. Conditions listed: Colorectal Cancer (CRC). Primary outcome: Progression-free Survival (PFS). Colorectal eligibility wording from the registry: \"Patients with metastatic colorectal adenocarcinoma confirmed by pathology or histology;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07051785","url":"https://clinicaltrials.gov/study/NCT07051785"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib","capecitabine","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07051785","phase":"2","setting":"Fruquintinib vs Bevacizumab Combined With Irinotecan Liposome and Capecitabine as Second-Line Therapy for Advanced Metastatic Colorectal Cancer：A Multicenter Randomized Controlled Trial","sponsor":"Liu Huang","started":"2025-07-07","startedType":"estimated","enrolled":68,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06441565","kind":"trial","name":"Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer","aka":[],"tldr":"A phase 2/3 trial of fruquintinib, fluorouracil (5-FU) and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer is a phase 2/3, randomised interventional study registered as NCT06441565 by Sun Yat-sen University, with a registry enrolment figure of 84 participants, started 2024-05-24 and due to reach its primary completion in 2025-12-30. Interventions recorded: Fruquintinib; Fluorouracil; Oxaliplatin. Conditions listed: Colorectal Cancer. Primary outcome: 6-month progression-free survival. Colorectal eligibility wording from the registry: \"* Histologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06441565","url":"https://clinicaltrials.gov/study/NCT06441565"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","kinase-inhibitors","platinum"],"targets":[],"drugs":["fruquintinib","fluorouracil","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06441565","phase":"2/3","setting":"Fruquintinib Plus Arterial Infusion Therapy With Hepatic FOLFOX for Refractory Colorectal Cancer: The FAITH Randomized Clinical Trial","sponsor":"Sun Yat-sen University","started":"2024-05-24","startedType":"actual","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06563986","kind":"trial","name":"FTD-TPI, Bevacizumab, and Radioembolization With 166Ho-microspheres in Refractory Metastatic Colorectal Cancer","aka":["STARLIGHT"],"tldr":"A phase 2 trial of bevacizumab (glioblastoma use) in colorectal cancer, run by UMC Utrecht, now recruiting.","summary":"FTD-TPI, Bevacizumab, and Radioembolization With 166Ho-microspheres in Refractory Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06563986 by UMC Utrecht, with a registry enrolment figure of 40 participants, started 2024-06-18 and due to reach its primary completion in 2028-01. Interventions recorded: Systemic treatment (FTD-TPI and bevacizumab); Radioembolization with 166-Ho microspheres. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Hepatic objective response rate (hORR) (PERCIST 1.0). Colorectal eligibility wording from the registry: \"* Prior therapy with fluoropyrimidine, oxaliplatin, and irinotecan for the treatment of metastatic colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06563986","url":"https://clinicaltrials.gov/study/NCT06563986"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06563986","phase":"2","setting":"Single-arm, Phase II Trial of Trifluridine/Tipiracil (FTD-TPI), Bevacizumab, and Individualized Radioembolization With 166Ho-microspheres in Refractory Metastatic Colorectal Cancer","sponsor":"UMC Utrecht","started":"2024-06-18","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03678428","kind":"trial","name":"FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM","aka":[],"tldr":"A phase 3 trial of Irinotecan, Floxuridine, Leucovorin, Fluorouracil and Oxaliplatin in Colorectal cancer, run by Sun Yat-sen University, recorded as terminated on the registry.","summary":"FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM is a phase 3 interventional study registered as NCT03678428 by Sun Yat-sen University, with 92 participants recorded, started 2021-12-31 and due to reach its primary completion in 2022-10-31. Interventions recorded: Irinotecan, Oxaliplatin HAI, Floxuridine, Leucovorin, 5-FU, Oxaliplatin. Conditions recorded: Metastatic Colorectal Cancer, Liver Metastases.\n\nLinked to the drug Floxuridine because the registry names it among its interventions and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03678428","url":"https://clinicaltrials.gov/study/NCT03678428"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["irinotecan","floxuridine","leucovorin","fluorouracil","oxaliplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03678428","phase":"3","setting":"FUDR/Oxaliplatin HAI Plus Irinotecan Chemotherapy vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM","sponsor":"Sun Yat-sen University","started":"2021-12-31","startedType":"actual","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07515963","kind":"trial","name":"FULIRI Plus Targeted Therapy for First-line Conversion Therapy of Colorectal Cancer Liver Metastases.","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Zhongnan Hospital, not yet recruiting.","summary":"FULIRI Plus Targeted Therapy for First-line Conversion Therapy of Colorectal Cancer Liver Metastases. is a phase 2, interventional study registered as NCT07515963 by Zhongnan Hospital, with a registry enrolment figure of 24 participants, started 2026-06-01 and due to reach its primary completion in 2027-02-01. Interventions recorded: FULIRI combination targeted therapy. Conditions listed: Colo-rectal Cancer. Primary outcome: Objective Response Rate (ORR). Colorectal eligibility wording from the registry: \"\\- (1) Age 18-75 years; (2) Histologically confirmed colorectal adenocarcinoma; (3) Synchronous liver metastasis of colorectal cancer, or liver metastasis occurring after curative surgery for colorectal cancer, and no prior systemic anti-tumor treatment (including but not limited to systemic chemoth\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07515963","url":"https://clinicaltrials.gov/study/NCT07515963"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07515963","phase":"2","setting":"A Phase II Clinical Study of FULIRI Regimen Chemotherapy Combined With Targeted Therapy for First-line Conversion Treatment of Colorectal Cancer Liver Metastases.","sponsor":"Zhongnan Hospital","started":"2026-06-01","startedType":"estimated","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07492342","kind":"trial","name":"Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC","aka":["K-NADIR"],"tldr":"A phase 2 trial of fulzerasib in lung cancer, run by Jianxing He, now recruiting.","summary":"Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC is a phase 2, interventional study registered as NCT07492342 by Jianxing He, with a registry enrolment figure of 30 participants, started 2026-01-29 and due to reach its primary completion in 2027-03-31. Interventions recorded: fulzerasib. Conditions listed: Resectable NSCLC; KRAS G12C Mutation; Stage IB-IIIA NSCLC; Neoadjuvant Therapy. Primary outcome: Pathological Complete Response, pCR. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07492342","url":"https://clinicaltrials.gov/study/NCT07492342"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["kras-g12c-nsclc","resectable-nsclc"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["fulzerasib"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07492342","phase":"2","setting":"Evaluation of Efficacy and Safety of Fulzerasib Sequentially Combined With Sintilimab Plus Platinum-Doublet Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Non-Small Cell Lung Cancer With KRAS G12 Mutation: a Single-Arm, Phase II Clinical Trial","sponsor":"Jianxing He","started":"2026-01-29","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"fumanba-1","kind":"trial","name":"FUMANBA-1","aka":[],"tldr":"The single-arm trial that won eque-cel its approval in China, with almost every patient responding and most reaching deep remissions.","summary":"Multicentre single-arm study reported in JAMA Oncology 2024: objective responses in about 96% of infused patients, high rates of stringent complete response and minimal residual disease negativity, durable responses including in patients previously exposed to CAR-T, and mostly grade 1 to 2 cytokine release syndrome. Basis of NMPA approval in June 2023, China's first fully human BCMA CAR-T.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT05066646","url":"https://clinicaltrials.gov/study/NCT05066646"},{"label":"JAMA Oncol 2024","url":"https://doi.org/10.1001/jamaoncol.2024.4879"}],"tags":["china"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["car-t"],"targets":["bcma"],"drugs":["equecabtagene-autoleucel"],"companies":["iaso-bio","innovent"],"institutions":["tongji-hospital-wuhan"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-li-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05066646","phase":"1/2","setting":"Relapsed or refractory multiple myeloma after three or more lines, China: single-arm study of equecabtagene autoleucel","sponsor":"IASO Biotherapeutics and Innovent Biologics","result":"ORR about 96% in infused patients (JAMA Oncol 2024).","started":"2020-04-01","startedType":"actual","yearReported":2024,"enrolled":103,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate (efficacy-evaluable)","primary":true,"unit":"%","arms":[{"name":"Equecabtagene autoleucel 1.0 × 10^6 CAR+ T cells/kg","n":101,"value":96,"note":"97 of 101 evaluable patients; 103 infused; median follow-up 13.8 months (data cut September 2022)"}],"source":"https://doi.org/10.1001/jamaoncol.2024.4879"},{"endpoint":"Complete response or better","unit":"%","arms":[{"name":"Equecabtagene autoleucel","n":103,"value":74.3,"note":"75 of 103 as reported"}],"source":"https://doi.org/10.1001/jamaoncol.2024.4879"},{"endpoint":"MRD negativity (10^-5)","unit":"%","arms":[{"name":"Equecabtagene autoleucel","value":95,"note":"96 patients"}],"source":"https://doi.org/10.1001/jamaoncol.2024.4879"},{"endpoint":"Progression-free survival at 12 months","unit":"%","arms":[{"name":"Equecabtagene autoleucel","value":78.8,"note":"Median PFS not reached"}],"ci":[68.6,86],"source":"https://doi.org/10.1001/jamaoncol.2024.4879"},{"endpoint":"Cytokine release syndrome, any grade","unit":"%","arms":[{"name":"Equecabtagene autoleucel","n":103,"value":93.2,"note":"Grade 1-2 in 92.3%; ICANS 1.9% (all grade 1-2)"}],"source":"https://doi.org/10.1001/jamaoncol.2024.4879"}],"replication":"Single-arm phase 1b/2 across 14 Chinese centres; no randomised comparison. The response rate sits alongside zevor-cel (LUMMICAR STUDY 1, ORR 92.2%) and cilta-cel (CARTITUDE-1), so the depth of response is consistent across fully human and llama-derived BCMA CAR-Ts; 9 of 12 patients previously exposed to another CAR-T responded."},{"id":"nct07289646","kind":"trial","name":"Functional Lung Avoidance Planning Guided by Lung Perfusion PET/CT Versus Anatomical Planning for Lung Stereotactic Body Radiotherapy","aka":["Pegasus 2"],"tldr":"A phase 3 trial in lung cancer, run by University Hospital, Brest, not yet recruiting.","summary":"Functional Lung Avoidance Planning Guided by Lung Perfusion PET/CT Versus Anatomical Planning for Lung Stereotactic Body Radiotherapy is a phase 3, randomised interventional study registered as NCT07289646 by University Hospital, Brest, with a registry enrolment figure of 418 participants, started 2026-01-15 and due to reach its primary completion in 2029-01-31. Interventions recorded: Conventional anatomical planning radiotherapy; Functional Lung avoidance planning. Conditions listed: Stereotactic Body Radiotherapy; 68Ga-MAA; Lung Cancer (Diagnosis). Primary outcome: To determine whether a functional planning guided by lung perfusion PET/CT imaging is superior to a conventional anatomical planning with regards to the occurrence of grade 2 or higher lung toxicity during the year following lung SBRT.. Lung eligibility wording from the registry: \"* Patients aged \\> 18 years planned to be treated in the radiotherapy department of the participating centers with SBRT for primary or secondary lung tumors will be eligible to participate into the study\". Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07289646","url":"https://clinicaltrials.gov/study/NCT07289646"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07289646","phase":"3","setting":"Functional Lung Avoidance Planning Guided by Lung Perfusion PET/CT Versus Anatomical Planning for Lung Stereotactic Body Radiotherapy","sponsor":"University Hospital, Brest","started":"2026-01-15","startedType":"estimated","enrolled":418,"enrolledBasis":"registry","outcomes":[]},{"id":"funen-fob","kind":"trial","name":"Funen faecal occult blood screening trial","aka":["Danish Funen trial"],"tldr":"The Danish population trial that, with Nottingham, showed a stool test posted every two years cuts bowel cancer deaths by about a fifth.","summary":"The Funen trial offered biennial Haemoccult testing to 30,967 people aged 45 to 75 and compared them with an unscreened control group. Of those invited, 20,672 (67 percent) completed the first round and more than 90 percent accepted repeat rounds. Over ten years 481 screened and 483 control participants were diagnosed with colorectal cancer, but there were 205 deaths from it in the screening group against 249 in controls, a mortality ratio of 0.82 (95% CI 0.68 to 0.99, p=0.03). Incidence was unchanged and mortality fell, which is the signature of earlier detection rather than prevention; the flexible sigmoidoscopy and colonoscopy trials that followed aimed at prevention by removing adenomas.","status":"positive","asOf":"2026-09-24","links":[{"label":"Funen: randomised study of screening for colorectal cancer with faecal-occult-blood test (Lancet 1996)","url":"https://doi.org/10.1016/S0140-6736(96)03430-7"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":["early-detection","prevention"],"technologies":["colorectal-screening"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["fit-test"],"trials":["nottingham-fob","minnesota-fob"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"People aged 45 to 75 in Funen, Denmark: biennial Haemoccult faecal occult blood testing against no screening","sponsor":"Odense University Hospital, Funen","result":"Colorectal cancer mortality ratio 0.82 (95% CI 0.68 to 0.99) over ten years, with unchanged incidence.","yearReported":1996,"enrolled":61933,"enrolledBasis":"randomised","enrolledNote":"30,967 people were randomised to screening and a matched control group of similar size; the trial began in 1985 and predates the registries.","outcomes":[{"endpoint":"Colorectal cancer mortality","primary":true,"unit":"mortality ratio","arms":[{"name":"Biennial faecal occult blood screening","n":30967,"value":0.82,"note":"205 deaths"},{"name":"Control","value":1,"note":"249 deaths"}],"ci":[0.68,0.99],"p":"0.03","source":"https://doi.org/10.1016/S0140-6736(96)03430-7"}],"replication":"Published in the same issue of the Lancet as the Nottingham trial, which found a 15 percent reduction."},{"id":"furlong","kind":"trial","name":"FURLONG","aka":[],"tldr":"The head-to-head trial in which furmonertinib nearly doubled the time before lung cancer grew compared with gefitinib, mirroring FLAURA with a Chinese drug.","summary":"358 patients, double blind. Median progression-free survival 20.8 versus 11.1 months (hazard ratio 0.44), with strong central nervous system activity and a tolerable safety profile. NMPA first-line approval June 2022. With AENEAS it gave China two domestic third-generation EGFR inhibitors competing with osimertinib on price after NRDL listing.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03787992","url":"https://clinicaltrials.gov/study/NCT03787992"},{"label":"Lancet Respir Med 2022","url":"https://doi.org/10.1016/S2213-2600(22)00168-0"}],"tags":["china"],"related":["flaura2","aeneas"],"cancers":["nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["egfr"],"drugs":["furmonertinib","gefitinib"],"companies":["allist"],"institutions":["shanghai-chest-hospital"],"pathways":[],"terms":[],"trials":[],"people":["lu-shun"],"bottlenecks":[],"keyPapers":["paper-furlong-lancet-respir-med-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03787992","phase":"3","setting":"First-line EGFR-mutant (exon 19 deletion or L858R) locally advanced or metastatic NSCLC, China: furmonertinib vs gefitinib","sponsor":"Shanghai Allist Pharmaceuticals","result":"PFS 20.8 vs 11.1 months, HR 0.44.","started":"2019-05-30","startedType":"actual","yearReported":2022,"enrolled":358,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Furmonertinib","n":178,"value":20.8},{"name":"Gefitinib","n":180,"value":11.1}],"hr":0.44,"source":"https://doi.org/10.1016/S2213-2600(22)00168-0"}]},{"id":"nct06674343","kind":"trial","name":"Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic NSCLC With EGFR Classical Mutations","aka":[],"tldr":"A phase 3 trial of furmonertinib in lung cancer, run by Peking Union Medical College Hospital, now recruiting.","summary":"Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic NSCLC With EGFR Classical Mutations is a phase 3, interventional study registered as NCT06674343 by Peking Union Medical College Hospital, with a registry enrolment figure of 144 participants, started 2024-07-15 and due to reach its primary completion in 2026-12-31. Interventions recorded: Furmonertinib. Conditions listed: Advanced or Metastatic Non-small Cell Lung Cancer. Primary outcome: Progression Freae Survival (PFS). Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed locally advanced or metastatic lung adenocarcinoma not amenable to curative surgery or radiotherapy;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06674343","url":"https://clinicaltrials.gov/study/NCT06674343"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["furmonertinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06674343","phase":"3","setting":"The Efficacy and Safety of Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With EGFR Classical Mutations, a Prospective, Single-arm, Multicenter Clinical Study","sponsor":"Peking Union Medical College Hospital","started":"2024-07-15","startedType":"actual","enrolled":144,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05334277","kind":"trial","name":"Furmonertinib Monotherapy and Combination Therapy in Advanced EGFR Mutant NSCLC With Uncleared ctDNA","aka":["FOCUS-C"],"tldr":"A phase 2 trial of furmonertinib, pemetrexed, carboplatin and bevacizumab in lung cancer, run by Sun Yat-sen University, now recruiting.","summary":"Furmonertinib Monotherapy and Combination Therapy in Advanced EGFR Mutant NSCLC With Uncleared ctDNA is a phase 2, randomised interventional study registered as NCT05334277 by Sun Yat-sen University, with a registry enrolment figure of 280 participants, started 2022-05-06 and due to reach its primary completion in 2025-02-28. Interventions recorded: Furmonertinib; Furmonertinib; Furmonertinib/Pemetrexed/Carboplatin; Furmonertinib/Pemetrexed/Carboplatin/Bevacizumab. Conditions listed: Non-small Cell Lung Cancer. Primary outcome: Progression-free survival (PFS). Lung eligibility wording from the registry: \"Pathologically confirmed non-squamous Non-Small Cell Lung Cancer (NSCLC);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05334277","url":"https://clinicaltrials.gov/study/NCT05334277"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","kinase-inhibitors","monoclonal-antibody","mrd-testing","platinum"],"targets":[],"drugs":["furmonertinib","pemetrexed","carboplatin","bevacizumab"],"companies":["allist"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05334277","phase":"2","setting":"FurmOnertinib Mesylate With or Without Chemotherapy +/- bevacizUmab as firSt Line Treatment in Advanced Non-small Cell Lung Cancer Patients With Uncleared Epidermal Growth Factor Receptor (EGFR) Mutation Positive Circulating Tumor Cell DNA","sponsor":"Sun Yat-sen University","started":"2022-05-06","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05749588","kind":"trial","name":"FUSCC Refractory TNBC Platform Study (FUTURE2.0)","aka":["FUTURE2.0"],"tldr":"A phase 2 trial of camrelizumab, everolimus, TQB2102 and TQB2868 in triple-negative breast cancer, run by Fudan University, now recruiting.","summary":"FUSCC Refractory TNBC Platform Study (FUTURE2.0) is a phase 2, interventional study registered as NCT05749588 by Fudan University, with a registry enrolment figure of 120 participants, started 2023-03-30 and due to reach its primary completion in 2027-12-31. Interventions recorded: A1: SHR-A1811; A2: SHR-A1811 with Camrelizumab with famitinib; B1: TROP2 ADC; B2: TROP2 ADC with Camrelizumab; C1: SHR-A1811; C2: SHR-A1811 with BP102; D1: TROP2 ADC; D2: TROP2 ADC with BP102; E1: SHR-A1811; F1: TROP2 ADC; G1: SHR-A1811; H1: TROP2 ADC; E2: SHR-A1811 with everolimus; TQB2102 with TQB2868. Conditions listed: Triple-negative Breast Cancer. Triple-negative eligibility wording from the registry: \"TNBC invasive breast cancer confirmed by histology (specific definition: ER \\<1% positive tumor cells by immunohistochemistry are defined as ER negative, PR \\<1% positive tumor cells are defined as PR negative, HER2 0-1+ or HER2 ++ but negative by FISH without amplification was defined as HER2 negat\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05749588","url":"https://clinicaltrials.gov/study/NCT05749588"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["camrelizumab","everolimus","tqb2102","tqb2868"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05749588","phase":"2","setting":"Precision Platform Study of Refractory Triple-negative Breast Cancer Based on Molecular Subtyping（(A Phase II, Open-label, Single-center Platform Study）","sponsor":"Fudan University","started":"2023-03-30","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07710885","kind":"trial","name":"Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer","aka":["FOENIX-BTC"],"tldr":"A phase 3 trial of Futibatinib, Zimberelimab, Durvalumab, Pembrolizumab, Gemcitabine and Cisplatin in biliary tract cancer, run by Taiho Pharmaceutical Co., Ltd., now recruiting.","summary":"Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer is a phase 3 interventional study registered as NCT07710885 by Taiho Pharmaceutical Co., Ltd., with 784 participants planned, started 2026-06-24 and due to reach its primary completion in 2030-04-30. Interventions recorded: Futibatinib, Zimberelimab, Durvalumab, Pembrolizumab, Gemcitabine and Cisplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07710885","url":"https://clinicaltrials.gov/study/NCT07710885"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","kinase-inhibitors","platinum"],"targets":[],"drugs":["futibatinib","zimberelimab","durvalumab","pembrolizumab","gemcitabine","cisplatin"],"companies":["araris"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07710885","phase":"3","setting":"A Phase 3, Randomized-Controlled, Open-Label, Multi-Regional, International Study of Futibatinib (TAS-120) and Zimberelimab (AB122) in Combination With Gemcitabine Plus Cisplatin Versus Durvalumab or Pembrolizumab in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers","sponsor":"Taiho Pharmaceutical Co., Ltd.","started":"2026-06-24","startedType":"actual","enrolled":784,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06722183","kind":"trial","name":"Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities","aka":["FUTURE"],"tldr":"A phase 2 trial of tislelizumab in colorectal cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, now recruiting.","summary":"Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities is a phase 2, interventional study registered as NCT06722183 by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, with a registry enrolment figure of 33 participants, started 2025-12-16 and due to reach its primary completion in 2028-03. Interventions recorded: Futibatinib orally administered; Tislelizumab (i.v. 200mg). Conditions listed: Colorectal Cancer. Primary outcome: Overall Response Rate (ORR) according to RECIST v1.1. Colorectal eligibility wording from the registry: \"• Specific for FUTURE-001: Histological or cytological confirmation of colorectal adenocarcinoma that is unresectable and/or metastatic with known RAS-, BRAF and MSI- status\". Sites: Germany. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06722183","url":"https://clinicaltrials.gov/study/NCT06722183"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06722183","phase":"2","setting":"FUTURE Platform Trial - A Phase II Platform Trial of Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities","sponsor":"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest","started":"2025-12-16","startedType":"estimated","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06506955","kind":"trial","name":"Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.","aka":[],"tldr":"A phase 2/3 trial of Futibatinib, Fulvestrant in metastatic cancer, run by Taiho Oncology, Inc., active and no longer recruiting.","summary":"Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy. is a phase 2/3 interventional study registered as NCT06506955 by Taiho Oncology, Inc., with 15 participants planned, started 2024-10-01 and due to reach its primary completion in 2027-04. Interventions recorded: futibatinib, futibatinib, fulvestrant. Conditions listed: Advanced/Metastatic Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06506955","url":"https://clinicaltrials.gov/study/NCT06506955"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["futibatinib","fulvestrant"],"companies":["taiho-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06506955","phase":"2/3","setting":"An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study","sponsor":"Taiho Oncology, Inc.","started":"2024-10-01","startedType":"actual","enrolled":15,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00541125","kind":"trial","name":"G-CSF in Preventing Neutropenia During First-Line Treatment With Chemotherapy and Bevacizumab in Patients With Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of UGT1A1 genotyping before irinotecan in Colorectal cancer, run by Federation Francophone de Cancerologie Digestive, completed.","summary":"G-CSF in Preventing Neutropenia During First-Line Treatment With Chemotherapy and Bevacizumab in Patients With Metastatic Colorectal Cancer is a phase 2 interventional study registered as NCT00541125 by Federation Francophone de Cancerologie Digestive, with 20 participants recorded, started 2007-11 and reaching its primary completion in 2013-09. Interventions recorded: bevacizumab, filgrastim, fluorouracil, irinotecan hydrochloride, leucovorin calcium. Conditions recorded: Colorectal Cancer.\n\nLinked to the technology UGT1A1 genotyping before irinotecan because the registry's title names it (\"ugt1a1 28\") and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00541125","url":"https://clinicaltrials.gov/study/NCT00541125"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["ugt1a1-genotyping"],"targets":[],"drugs":["filgrastim","fluorouracil","irinotecan","leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00541125","phase":"2","setting":"Phase II, Multicenter Study Evaluating G-CSF as Primary Prophylaxis for Neutropenia Associated With First-line Chemotherapy Regimen FOLFIRI and Bevacizumab in Patients With Metastatic Colorectal Cancer Who Are Homozygous for UGT1A1*28 Polymorphism, the Promoter of the Gene Encoding for the Enzyme UGT1A1","sponsor":"Federation Francophone de Cancerologie Digestive","started":"2007-11","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05438459","kind":"trial","name":"GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites","aka":["GAIA-102"],"tldr":"A phase 1/2 trial of pembrolizumab, trifluridine/tipiracil and fluorouracil (5-FU) in pancreatic cancer, run by Kyushu University, now recruiting.","summary":"GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites is a phase 1/2, randomised interventional study registered as NCT05438459 by Kyushu University, with a registry enrolment figure of 176 participants, started 2022-06-08 and due to reach its primary completion in 2032-03-31. Interventions recorded: GAIA-102; GAIA-102; Pembrolizumab; Pembrolizumab; Trifluridine/tipiracil hydrochloride (FTD/TPI); Irinotecan hydrochloride hydrate; Calcium levofolinate hydrate; Fluorouracil. Conditions listed: Gastric Cancer; Pancreatic Cancer. Primary outcome: Number of participants of Dose Limiting Toxicity (DLT) with GAIA-102 (Phase I); Frequency and severity of adverse events(Phase I); Overall survival in patients with gastric cancer (Phase II). Pancreatic eligibility wording from the registry: \"* Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with malignant ascites, as well as unresectable or advanced recurrent pancreatic cancer\". Sites: Japan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05438459","url":"https://clinicaltrials.gov/study/NCT05438459"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["pembrolizumab","trifluridine-tipiracil","fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05438459","phase":"1/2","setting":"Clinical Trial of Repeated Intraperitoneal Administration of GAIA-102 in Patients With Advanced Gastrointestinal Cancer (Gastric Cancer / Pancreatic Cancer) of Microsatellite Stable (MSS) With Malignant Ascites (Phase I / II Investigator-initiated Clinical Trial) (GAIA-102-PD Clinical Trial)","sponsor":"Kyushu University","started":"2022-06-08","startedType":"actual","enrolled":176,"enrolledBasis":"registry","outcomes":[]},{"id":"gain-igbc","kind":"trial","name":"GAIN (AIO/CALGP/ACO)","aka":["GAIN","GAIN-Trial"],"tldr":"The German GAIN trial tried to test chemotherapy before the second operation for gallbladder cancer found by chance. It planned 333 patients but closed in October 2024 after enrolling 68, so it is unlikely to answer the question on its own.","summary":"GAIN (NCT03673072) was a multicentre, open-label randomised phase 3 run through the German Registry of Incidental Gallbladder Carcinoma with AIO, CALGP and ACO. Patients with incidental gallbladder carcinoma after simple cholecystectomy awaiting radical liver resection, or with resectable or borderline resectable intrahepatic or extrahepatic cholangiocarcinoma, were randomised to perioperative gemcitabine and cisplatin (three cycles before and three after surgery) or surgery alone followed by investigator's choice of therapy. The primary endpoint was overall survival with progression-free survival, R0 rate, toxicity, perioperative morbidity and quality of life as secondary endpoints, and 333 patients were planned. The registry lists the trial as completed on 10 October 2024 with an actual enrolment of 68, about a fifth of the target, at a single German site entry. No results were found in Europe PMC in September 2026. Together with OPT-IN it represents the only randomised attempt to move chemotherapy ahead of re-resection in incidental gallbladder cancer.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03673072","url":"https://clinicaltrials.gov/study/NCT03673072"},{"label":"Goetze et al., BMC Cancer 2020: GAIN protocol","url":"https://doi.org/10.1186/s12885-020-6610-4"}],"tags":[],"related":["opt-in"],"cancers":["gallbladder","cholangiocarcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","gallbladder-cancer-surgery"],"targets":[],"drugs":["gemcitabine-cisplatin","gemcitabine","cisplatin"],"companies":[],"institutions":["krankenhaus-nordwest"],"pathways":[],"terms":["radical-cholecystectomy","neoadjuvant-adjuvant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-gain-trial-protocol-bmc-cancer-2020","paper-varshney-neoadjuvant-incidental-gallbladder-cancer-systematic-review-ahbps-2025"],"journals":[],"dependsOn":[],"notes":["Key facts: perioperative gemcitabine and cisplatin (three cycles before and after radical resection) versus surgery first, for incidental gallbladder carcinoma after simple cholecystectomy and for resectable cholangiocarcinoma; primary endpoint overall survival; 333 planned, 68 enrolled, completed 10 October 2024 with no stated reason; no results in Europe PMC in September 2026.","Enrolment: the registry gives 68 actual against 333 planned in the protocol paper; the trial is recorded as completed on 2024-10-10 without a stated reason."],"nct":"NCT03673072","phase":"3","setting":"Incidentally detected gallbladder carcinoma after simple cholecystectomy, or resectable cholangiocarcinoma: three cycles of gemcitabine and cisplatin before and after radical liver resection versus immediate radical resection with or without adjuvant therapy","sponsor":"Krankenhaus Nordwest","started":"2019-07-01","startedType":"actual","enrolled":68,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04229979","kind":"trial","name":"Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2","aka":["REGAL"],"tldr":"A phase 3 trial of Azacitidine, Venetoclax, Decitabine and Cytarabine in acute myeloid leukaemia, run by Sellas Life Sciences Group, active and no longer recruiting.","summary":"Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 is a phase 3 interventional study registered as NCT04229979 by Sellas Life Sciences Group, with 127 participants enrolled, started 2021-02-08 and due to reach its primary completion in 2025-12. Interventions recorded: Galinpepimut-S, Azacitidine, Venetoclax, Decitabine, Cytarabine and GM-CSF.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04229979","url":"https://clinicaltrials.gov/study/NCT04229979"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":["azacitidine","venetoclax","decitabine","cytarabine"],"companies":["galena-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04229979","phase":"3","setting":"A Randomized, Open-Label Study of the Efficacy and Safety of Galinpepimut-S (GPS) Maintenance Monotherapy Compared to Investigator's Choice of Best Available Therapy in Subjects With Acute Myeloid Leukemia Who Have Achieved Complete Remission After Second-Line Salvage Therapy","sponsor":"Sellas Life Sciences Group","started":"2021-02-08","startedType":"actual","enrolled":127,"enrolledBasis":"registry","outcomes":[]},{"id":"gallium","kind":"trial","name":"GALLIUM","aka":["BO21223"],"tldr":"GALLIUM showed that the newer anti-CD20 antibody obinutuzumab kept follicular lymphoma at bay for longer than rituximab when given with chemotherapy and as maintenance, at the cost of more serious side effects, and it became a first-line option.","summary":"GALLIUM was an open-label phase 3 trial in 1,401 patients with previously untreated advanced indolent non-Hodgkin lymphoma, 1,202 of them with follicular lymphoma, randomised to obinutuzumab or rituximab with bendamustine, CHOP or CVP chosen by the centre, followed by antibody maintenance for two years in responders. The primary endpoint was investigator-assessed progression-free survival in the follicular lymphoma population.\n\nAt a planned interim analysis with a median follow-up of 34.5 months, obinutuzumab reduced the risk of progression, relapse or death by a third (three-year progression-free survival 80.0 against 73.3 percent). Response rates were similar, but grade 3 to 5 adverse events (74.6 against 67.8 percent) and serious adverse events were more frequent with obinutuzumab. The result led to approval of obinutuzumab for untreated follicular lymphoma in 2017, and the corpus's follicular lymphoma page lists bendamustine-obinutuzumab alongside bendamustine-rituximab on this trial.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01332968","url":"https://clinicaltrials.gov/study/NCT01332968"}],"tags":["soc-trials"],"related":["lymphoma-roadmap","goya","prima-follicular","fortplus"],"cancers":["follicular-lymphoma","marginal-zone-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["obinutuzumab","rituximab","bendamustine","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-gallium-obinutuzumab-first-line-follicular-lymphoma-marcus-nejm-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01332968","phase":"3","setting":"Previously untreated advanced indolent non-Hodgkin lymphoma, mainly follicular lymphoma: obinutuzumab or rituximab with the investigator's chemotherapy (bendamustine, CHOP or CVP), followed by two years of maintenance with the same antibody","sponsor":"Hoffmann-La Roche","result":"Three-year progression-free survival 80.0 percent with obinutuzumab-chemotherapy against 73.3 percent with rituximab-chemotherapy (hazard ratio 0.66, p 0.001); more grade 3 to 5 adverse events with obinutuzumab.","started":"2011-07-06","startedType":"actual","yearReported":2017,"enrolled":1401,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 3 years, follicular lymphoma (investigator-assessed)","primary":true,"unit":"%","arms":[{"name":"Obinutuzumab + chemotherapy, then obinutuzumab maintenance","n":601,"value":80,"note":"Median follow-up 34.5 months"},{"name":"Rituximab + chemotherapy, then rituximab maintenance","n":601,"value":73.3}],"hr":0.66,"ci":[0.51,0.85],"p":"0.001","source":"https://doi.org/10.1056/NEJMoa1614598"},{"endpoint":"Patients with a progression-free survival event, follicular lymphoma (registry results)","unit":"%","arms":[{"name":"Obinutuzumab + chemotherapy","value":16.8},{"name":"Rituximab + chemotherapy","value":24}],"hr":0.66,"ci":[0.51,0.85],"p":"0.0012","source":"https://clinicaltrials.gov/study/NCT01332968?tab=results"},{"endpoint":"Overall response rate","unit":"%","arms":[{"name":"Obinutuzumab + chemotherapy","n":601,"value":88.5},{"name":"Rituximab + chemotherapy","n":601,"value":86.9}],"source":"https://doi.org/10.1056/NEJMoa1614598"},{"endpoint":"Grade 3 to 5 adverse events","unit":"%","arms":[{"name":"Obinutuzumab + chemotherapy","value":74.6},{"name":"Rituximab + chemotherapy","value":67.8}],"source":"https://doi.org/10.1056/NEJMoa1614598"},{"endpoint":"Infusion-related events attributed to the antibody","unit":"%","arms":[{"name":"Obinutuzumab + chemotherapy","n":595,"value":59.3},{"name":"Rituximab + chemotherapy","n":597,"value":48.9}],"source":"https://doi.org/10.1056/NEJMoa1614598"}]},{"id":"garnet","kind":"trial","name":"GARNET","aka":[],"tldr":"GARNET showed that the PD-1 antibody dostarlimab produced lasting responses in about four in ten women with mismatch repair-deficient endometrial cancer that had returned after chemotherapy, which won the drug its first approvals.","summary":"GARNET was a large phase 1 dose-finding and expansion study of dostarlimab, a PD-1 antibody, in advanced solid tumours. Its expansion cohorts enrolled recurrent or advanced endometrial cancer after platinum, split by mismatch repair status, and a cohort of non-endometrial mismatch repair-deficient tumours. The primary endpoints for the expansion cohorts were objective response rate and duration of response by independent review.\n\nIn the mismatch repair-deficient endometrial cohort roughly four in ten patients responded and most responses were durable, with a lower response rate in the proficient cohort. Dostarlimab received accelerated approval in the United States in April 2021 for mismatch repair-deficient recurrent endometrial cancer and later a tumour-agnostic approval for mismatch repair-deficient solid tumours; the RUBY trial then moved it into first line with chemotherapy.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02715284","url":"https://clinicaltrials.gov/study/NCT02715284"}],"tags":["subtype-trials"],"related":[],"cancers":["endometrial-mmr-deficient","endometrial"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ana-oaknin"],"bottlenecks":[],"keyPapers":["paper-garnet-dostarlimab-oaknin-jama-oncol-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02715284","phase":"1","setting":"Advanced solid tumours, with expansion cohorts in mismatch repair-deficient and mismatch repair-proficient recurrent or advanced endometrial cancer after platinum chemotherapy and in other mismatch repair-deficient tumours: single-arm dostarlimab","sponsor":"Tesaro (GSK)","result":"Dostarlimab produced durable objective responses in roughly four in ten patients with mismatch repair-deficient recurrent endometrial cancer; accelerated approval in April 2021.","started":"2016-03-07","startedType":"actual","yearReported":2020,"enrolled":729,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (blinded independent central review), mismatch repair-deficient endometrial cancer","primary":true,"unit":"%","arms":[{"name":"Dostarlimab","n":71,"value":42.3,"note":"95% CI 30.6 to 54.6; median follow-up 11.2 months"}],"source":"https://doi.org/10.1001/jamaoncol.2020.4515"},{"endpoint":"Confirmed complete response","unit":"%","arms":[{"name":"Dostarlimab","n":71,"value":12.7}],"source":"https://doi.org/10.1001/jamaoncol.2020.4515"},{"endpoint":"Probability of maintaining response at 12 months","unit":"%","arms":[{"name":"Dostarlimab","value":76.8}],"source":"https://doi.org/10.1001/jamaoncol.2020.4515"}]},{"id":"nct07294261","kind":"trial","name":"Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC is a phase 2, randomised interventional study registered as NCT07294261 by Sun Yat-sen University, with a registry enrolment figure of 69 participants, started 2025-12-23 and due to reach its primary completion in 2028-10-30. Interventions recorded: Garsorasib, Benmelstobart, Anlotinib; Benmelstobart, Anlotinib; Garsorasib, Cetuximab Beta Injection. Conditions listed: Local Advanced or Metastatic NSCLC. Primary outcome: Overall response rate (ORR); DoR. Lung eligibility wording from the registry: \"Histologically confirmed IIIB-IV NSCLC\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07294261","url":"https://clinicaltrials.gov/study/NCT07294261"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["kras-g12c-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07294261","phase":"2","setting":"A Multicenter, Prospective Clinical Study Evaluating Goselasib Combination Therapy for First-Line Treatment of KRAS G12C Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Sun Yat-sen University","started":"2025-12-23","startedType":"estimated","enrolled":69,"enrolledBasis":"registry","outcomes":[]},{"id":"gatsby","kind":"trial","name":"GATSBY","aka":[],"tldr":"GATSBY tested whether the antibody-drug conjugate trastuzumab emtansine, which works in HER2-positive breast cancer, would also beat chemotherapy in HER2-positive stomach cancer after first treatment; it did not, and the drug was never approved for this cancer.","summary":"GATSBY was an adaptive phase 2/3 trial in HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma that had progressed during or after first-line therapy. Stage 1 randomised patients to two dose schedules of trastuzumab emtansine or to a taxane chosen by the investigator; the 2.4 mg/kg weekly schedule was carried into stage 2 against taxane alone.\n\nTrastuzumab emtansine did not improve overall survival over taxane, the primary endpoint, and the trial was stopped. Together with the earlier failure of lapatinib in this setting, GATSBY showed that HER2 loss and heterogeneity after trastuzumab make second-line HER2 targeting in gastric cancer harder than in breast cancer; the later success of trastuzumab deruxtecan in DESTINY-Gastric01 came from a payload that also kills neighbouring HER2-negative cells.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01641939","url":"https://clinicaltrials.gov/study/NCT01641939"}],"tags":["subtype-trials"],"related":[],"cancers":["gastric-her2-positive","gastric"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-emtansine","docetaxel","paclitaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["peter-thuss-patience"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01641939","phase":"2/3","setting":"HER2-positive advanced gastric or gastro-oesophageal junction cancer progressing after first-line therapy: trastuzumab emtansine against a taxane (docetaxel or paclitaxel)","sponsor":"Roche","result":"Trastuzumab emtansine did not improve overall survival over taxane chemotherapy in previously treated HER2-positive gastric cancer.","started":"2012-09-03","startedType":"actual","yearReported":2017,"enrolled":415,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (final analysis)","primary":true,"unit":"months","arms":[{"name":"Trastuzumab emtansine 2.4 mg/kg weekly","n":228,"value":7.9,"note":"Median follow-up 17.5 months"},{"name":"Taxane (docetaxel or paclitaxel)","n":117,"value":8.6}],"hr":1.15,"ci":[0.87,1.51],"p":"0.86 (one-sided)","source":"https://doi.org/10.1016/s1470-2045(17)30111-0"},{"endpoint":"Grade 3 or worse adverse events","unit":"%","arms":[{"name":"Trastuzumab emtansine 2.4 mg/kg weekly","n":224,"value":60},{"name":"Taxane (docetaxel or paclitaxel)","n":111,"value":70}],"source":"https://doi.org/10.1016/s1470-2045(17)30111-0"}]},{"id":"gbm-agile","kind":"trial","name":"GBM AGILE","aka":["GBM-AGILE","Glioblastoma Adaptive Global Innovative Learning Environment"],"tldr":"GBM AGILE is the glioblastoma trial that never ends: new drugs enter, are tested against the same standard treatment in newly diagnosed and recurrent patients at once, and either graduate to a confirmatory stage or are dropped. Its first drug, regorafenib, did not help, which the trial established faster and more cheaply than a stand-alone study would have.","summary":"GBM AGILE was designed between 2015 and 2018 by a consortium of neuro-oncologists and statisticians, including Timothy Cloughesy, Brian Alexander, Meredith Buxton and Donald Berry, and is sponsored by the Global Coalition for Adaptive Research, a non-profit created to run it. The design paper appeared in Clinical Cancer Research in 2018 and the trial opened in July 2019 in the United States, since extended to Canada, Europe and China. Patients with newly diagnosed glioblastoma, split by MGMT promoter methylation, and patients with recurrent disease all enter one protocol; the control arm receives temozolomide with radiotherapy (newly diagnosed) or lomustine or another standard (recurrent). Randomisation is response-adaptive within each population, overall survival is the endpoint, and an arm that reaches a pre-set probability of success moves seamlessly into a second, confirmatory stage sized to support approval.\n\nThe first experimental arm, regorafenib, enrolled from 2019 and its results were reported at the 2024 European neuro-oncology meeting and published in the Journal of Clinical Oncology in 2026: regorafenib did not improve overall survival in any of the populations, closing the question raised by the small REGOMA trial. Paxalisib and VAL-083 completed their first stages without meeting the graduation criteria. Troriluzole, VT1021 and azeliragon entered later, and the platform continues to add arms.\n\nGBM AGILE has changed how glioblastoma drugs are tested: companies can enter a single arm without building their own registration trial, patients in newly diagnosed and recurrent settings are studied together, and negative answers arrive in about two years. Whether a graduated arm will be accepted for approval on platform data alone is the test the trial has not yet faced, and the JCO editorial on its regorafenib experience debates how much a shared, evolving control can be trusted over a decade.","status":"recruiting","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03970447","url":"https://clinicaltrials.gov/study/NCT03970447"},{"label":"Global Coalition for Adaptive Research: GBM AGILE","url":"https://www.gcaresearch.org"},{"label":"Alexander et al., Clinical Cancer Research 2018: Adaptive Global Innovative Learning Environment for Glioblastoma, GBM AGILE","url":"https://doi.org/10.1158/1078-0432.CCR-17-0764"},{"label":"Evaluation of regorafenib in newly diagnosed and recurrent glioblastoma: GBM AGILE phase II/III Bayesian randomized platform trial, Journal of Clinical Oncology 2026","url":"https://doi.org/10.1200/JCO-25-01137"},{"label":"Lessons from GBM AGILE's regorafenib experience, Journal of Clinical Oncology 2026","url":"https://doi.org/10.1200/JCO-26-00444"}],"tags":[],"related":[],"cancers":["glioblastoma","brain-tumours"],"sections":[],"technologies":["kinase-inhibitors","digital-twins-trials"],"targets":[],"drugs":["regorafenib","temozolomide","lomustine"],"companies":[],"institutions":["ucla-jonsson"],"pathways":[],"terms":["master-protocol","seamless-adaptive","interim-analysis"],"trials":[],"people":["timothy-cloughesy"],"bottlenecks":["b-trial-design"],"keyPapers":["paper-alexander-clin-cancer-res","paper-wen-j-clin-oncol","paper-ballman-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03970447","phase":"platform","setting":"Newly diagnosed glioblastoma (MGMT methylated and unmethylated) and recurrent glioblastoma: a Bayesian adaptive platform that screens experimental drugs against a shared standard-of-care control on overall survival and lets a winning arm expand seamlessly into a confirmatory stage","sponsor":"Global Coalition for Adaptive Research","result":"Regorafenib, the first arm, did not improve overall survival in newly diagnosed or recurrent glioblastoma; paxalisib and VAL-083 did not graduate; later arms continue.","started":"2019-07-30","startedType":"actual","yearReported":2024,"enrolledBasis":"registry","outcomes":[]},{"id":"gd2-cart01","kind":"trial","name":"GD2-CART01 (Bambino Gesù phase 1/2)","aka":[],"tldr":"GD2-CART01 was the first CAR-T to produce durable complete remissions in a childhood solid tumour: two-thirds responded and a third achieved complete remission.","summary":"NEJM 2023: ORR 63%, CR 33%; 3-year OS 60%, EFS 36%; grade 1-2 CRS common, one grade 3; safety switch not needed. Nature Medicine 2025 long-term update: ORR 66%, complete responses sustained 8-18+ years in earlier-generation recipients, and 5 of 8 patients treated in remission disease-free at 10-15 years. Phase 2 expansion and commercialisation (Italy) under way.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03373097","url":"https://clinicaltrials.gov/study/NCT03373097"},{"label":"Nature Medicine 2025 long-term","url":"https://www.nature.com/articles/s41591-025-03513-0"}],"tags":[],"related":[],"cancers":["neuroblastoma","neuroblastoma-high-risk"],"sections":[],"technologies":["car-t","armored-car"],"targets":["gd2"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["crs"],"trials":[],"people":["crystal-mackall"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03373097","phase":"1/2","setting":"Relapsed/refractory high-risk neuroblastoma: third-generation GD2 CAR-T with inducible caspase-9 safety switch","sponsor":"Ospedale Pediatrico Bambino Gesù","result":"ORR 63%, CR 33%; 3-year OS 60%.","started":"2018-01-05","startedType":"actual","yearReported":2023,"enrolled":27,"enrolledBasis":"treated","enrolledNote":"ClinicalTrials.gov lists an estimated 42 participants for the phase 1/2 study, which is still active; the NEJM 2023 paper reports the 27 patients treated.","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"GD2-CART01","n":27,"value":63}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2210859"},{"endpoint":"Overall survival at 3 years","unit":"%","arms":[{"name":"GD2-CART01","value":60}],"source":"https://doi.org/10.1056/NEJMoa2210859"}],"replication":"Stanford GD2 CAR-T (with IL-15, in DIPG/DMG) and Baylor GD2 CAR-T show consistent GD2 targetability; no randomised trial yet."},{"id":"nct06190899","kind":"trial","name":"Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer","aka":[],"tldr":"A phase 1/2 trial of Gedatolisib, Darolutamide in prostate cancer, run by Celcuity Inc, now recruiting.","summary":"Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer is a phase 1/2 interventional study registered as NCT06190899 by Celcuity Inc, with 54 participants planned, started 2024-01-01 and due to reach its primary completion in 2028-01. Interventions recorded: Gedatolisib, Darolutamide. Conditions listed: mCRPC (Metastatic Castration-resistant Prostate Cancer), Genital Diseases, Male, Urogenital Diseases, Male, Prostatic Disease. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06190899","url":"https://clinicaltrials.gov/study/NCT06190899"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation","kinase-inhibitors"],"targets":[],"drugs":["gedatolisib","darolutamide"],"companies":["celcuity"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06190899","phase":"1/2","setting":"A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)","sponsor":"Celcuity Inc","started":"2024-01-01","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05501886","kind":"trial","name":"Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)","aka":["VIKTORIA-1"],"tldr":"A phase 3 trial of Gedatolisib, Palbociclib, Fulvestrant and Alpelisib in advanced solid tumours, run by Celcuity Inc, active and no longer recruiting.","summary":"Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) is a phase 3 interventional study registered as NCT05501886 by Celcuity Inc, with 701 participants enrolled, started 2022-12-08 and due to reach its primary completion in 2026-06-30. Interventions recorded: Gedatolisib, Palbociclib, Fulvestrant and Alpelisib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05501886","url":"https://clinicaltrials.gov/study/NCT05501886"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy","kinase-inhibitors"],"targets":[],"drugs":["gedatolisib","palbociclib","fulvestrant","alpelisib"],"companies":["celcuity"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05501886","phase":"3","setting":"Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy","sponsor":"Celcuity Inc","started":"2022-12-08","startedType":"actual","enrolled":701,"enrolledBasis":"registry","outcomes":[]},{"id":"gefitinib-chemo-tmh","kind":"trial","name":"Gefitinib vs gefitinib plus pemetrexed-carboplatin in EGFR-mutant lung cancer (Tata Memorial)","aka":[],"tldr":"An Indian trial showed that adding standard chemotherapy to the cheap first-generation pill gefitinib doubled the time lung cancer stayed controlled and cut deaths by more than half.","summary":"350 patients were randomised (176 gefitinib, 174 gefitinib plus pemetrexed-carboplatin). Median progression-free survival was 16 months with the combination versus 8 months with gefitinib alone (hazard ratio for progression or death 0.51; P<0.001); median overall survival was not reached versus 17 months (hazard ratio for death 0.45; P<0.001); response rates were 75% versus 63%, at the cost of more grade 3 or worse toxicity (51% versus 25%). With the Japanese NEJ009 trial it established EGFR inhibitor plus chemotherapy as an option, and offered a low-cost alternative where osimertinib is unaffordable; the approach later re-emerged in FLAURA2.","status":"positive","asOf":"2026-09-10","links":[{"label":"Noronha et al., JCO 2020","url":"https://doi.org/10.1200/JCO.19.01154"}],"tags":[],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors","cytotoxic-chemotherapy"],"targets":["egfr"],"drugs":["gefitinib","pemetrexed","carboplatin"],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":["pfs"],"trials":[],"people":["noronha-vanita","prabhash-kumar"],"bottlenecks":["b-drug-pricing","b-global-access"],"keyPapers":["paper-noronha-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Untreated advanced EGFR-mutant non-small-cell lung cancer: gefitinib alone vs gefitinib plus pemetrexed and carboplatin","sponsor":"Tata Memorial Centre","result":"PFS 16 vs 8 months (HR 0.51); OS not reached vs 17 months (HR 0.45).","yearReported":2020,"enrolled":350,"enrolledBasis":"registry","outcomes":[{"endpoint":"Median progression-free survival","primary":true,"unit":"months","arms":[{"name":"Gefitinib + pemetrexed-carboplatin","n":174,"value":16},{"name":"Gefitinib","n":176,"value":8}],"hr":0.51,"p":"<0.001","source":"https://doi.org/10.1200/JCO.19.01154"}]},{"id":"geicam-ciboma","kind":"trial","name":"GEICAM/2003-11_CIBOMA/2004-01","aka":["CIBOMA","GEICAM/CIBOMA","GEICAM 2003-11"],"tldr":"This Spanish and Latin American trial gave eight extra cycles of capecitabine after standard chemotherapy for early triple-negative breast cancer and did not significantly reduce relapses. Only tumours without the basal-like pattern seemed to benefit, a finding that still needs confirmation.","summary":"GEICAM/2003-11_CIBOMA/2004-01 (NCT00130533) randomised 876 patients with operable triple-negative breast cancer (node-positive, or node-negative with a tumour of 1 cm or more) who had completed anthracycline or taxane chemotherapy to capecitabine (448) or observation (428), stratified by basal phenotype on cytokeratin 5/6 and EGFR staining (73.9 percent basal). At a median follow-up of 7.3 years disease-free survival was not significantly prolonged (hazard ratio 0.82, 95 percent confidence interval 0.63 to 1.06, p 0.136). In a preplanned subgroup analysis non-basal tumours had a disease-free survival hazard ratio of 0.53 against 0.94 in basal tumours (interaction p 0.069) and an overall survival hazard ratio of 0.42 against 1.23 (interaction p 0.0052); 75.2 percent completed the eight cycles. With CREATE-X (positive in residual disease) and SYSUCC-001 (positive for disease-free survival with a metronomic schedule) it defines where capecitabine helps: after residual disease rather than in unselected early triple-negative disease.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00130533","url":"https://clinicaltrials.gov/study/NCT00130533"},{"label":"Lluch et al., JCO 2020: adjuvant capecitabine after standard neo/adjuvant chemotherapy in early TNBC (GEICAM/CIBOMA)","url":"https://doi.org/10.1200/JCO.19.00904"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":["roche-genentech","geicam"],"institutions":[],"pathways":[],"terms":["efs"],"trials":["create-x","sysucc-001"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00130533","phase":"3","setting":"Operable early triple-negative breast cancer after standard anthracycline or taxane chemotherapy: eight cycles of extended adjuvant capecitabine versus observation, Spain and Latin America","sponsor":"GEICAM Spanish Breast Cancer Group, with CIBOMA and Roche","result":"DFS HR 0.82 (0.63 to 1.06), p 0.136, not significant; non-basal subgroup DFS HR 0.53 vs basal 0.94 (interaction p 0.069).","started":"2006-01","startedType":"actual","yearReported":2020,"enrolled":876,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival","primary":true,"arms":[{"name":"Extended adjuvant capecitabine","n":448},{"name":"Observation","n":428}],"hr":0.82,"ci":[0.63,1.06],"p":"0.136","source":"https://doi.org/10.1200/JCO.19.00904"}],"replication":"CREATE-X positive in residual disease; SYSUCC-001 positive with a metronomic year."},{"id":"nct06963060","kind":"trial","name":"Gem+Nab-P+LEN+TIS for Advanced Unresectable BTC (GALENT-BT)","aka":["GALENT-BT"],"tldr":"A phase 2 trial of tislelizumab, gemcitabine, nab-paclitaxel and lenvatinib in gallbladder cancer and other biliary tract cancers, run by Wei Gong, now recruiting.","summary":"Gem+Nab-P+LEN+TIS for Advanced Unresectable BTC (GALENT-BT) is a phase 2 interventional study registered as NCT06963060 by Wei Gong, with a registry enrolment figure of 44 participants, started 2024-06-01 and due to reach its primary completion in 2027-06-30. Interventions recorded: Gemcitabine nab-PaclitaxelLenvatinibTislelizumab. Conditions listed: Gallbladder Cancer, Cholangiocarcinoma. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06963060","url":"https://clinicaltrials.gov/study/NCT06963060"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["tislelizumab","gemcitabine","nab-paclitaxel","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06963060","phase":"2","setting":"Xinhua Hospital A Ffiliated to Shanghai Jiaotong University School of Medicine","sponsor":"Wei Gong","started":"2024-06-01","startedType":"actual","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03498326","kind":"trial","name":"Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer","aka":["GCRP"],"tldr":"A phase 2 trial of gemcitabine in pancreatic cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer is a phase 2, randomised interventional study registered as NCT03498326 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 480 participants, started 2018-04-02 and due to reach its primary completion in 2023-03-31. Interventions recorded: Gemcitabine; Gemcitabine. Conditions listed: Pancreatic Cancer; Chemotherapy Effect. Primary outcome: disease free survival. Pancreatic eligibility wording from the registry: \"Endocrine carcinoma, acinar pancreatic carcinoma, or cystadenocarcinoma (cystadenocarcinoma)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03498326","url":"https://clinicaltrials.gov/study/NCT03498326"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03498326","phase":"2","setting":"Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2018-04-02","startedType":"actual","enrolled":480,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07310069","kind":"trial","name":"Gemcitabine and Nab-Paclitaxel Combined With Iparomlimab and Tuvorilimab for Advanced Gallbladder Cancer","aka":["TRANSFORM-GBC"],"tldr":"A phase 2 trial of gemcitabine and nab-paclitaxel in gallbladder cancer, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, now recruiting.","summary":"Gemcitabine and Nab-Paclitaxel Combined With Iparomlimab and Tuvorilimab for Advanced Gallbladder Cancer is a phase 2 interventional study registered as NCT07310069 by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, with a registry enrolment figure of 44 participants, started 2025-05-01 and due to reach its primary completion in 2027-05-01. Interventions recorded: Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili. Conditions listed: Gallbladder Cancer Unresectable. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07310069","url":"https://clinicaltrials.gov/study/NCT07310069"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07310069","phase":"2","setting":"A Phase II, Single-Arm, Multicenter Study of Gemcitabine and Nab-Paclitaxel in Combination With Iparomlimab and Tuvorilimab in Patients With Advanced Gallbladder Cancer","sponsor":"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine","started":"2025-05-01","startedType":"actual","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06591650","kind":"trial","name":"Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer","aka":["GCND"],"tldr":"A phase 2 trial of durvalumab, gemcitabine, cisplatin and nab-paclitaxel in gallbladder cancer, run by Fudan University, now recruiting.","summary":"Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer is a phase 2 interventional study registered as NCT06591650 by Fudan University, with a registry enrolment figure of 33 participants, started 2024-10-24 and due to reach its primary completion in 2026-10-30. Interventions recorded: gemcitabine hydrochloride, Cisplatin, Nab-paclitaxel, Durvalumab. Conditions listed: Gallbladder Cancer Unresectable. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06591650","url":"https://clinicaltrials.gov/study/NCT06591650"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["durvalumab","gemcitabine","cisplatin","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06591650","phase":"2","setting":"A Phase II Study of Gemcitabine, Cisplatin, Nab-Paclitaxel, and Durvalumab in Locally Advanced or Metastatic Gallbladder Cancer","sponsor":"Fudan University","started":"2024-10-24","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06897644","kind":"trial","name":"Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLFIRINOX as 1st Line Chemotherapy in Patients With Advanced Pancreatic C","aka":["PANThEON"],"tldr":"A phase 3 trial of cAPOX (capecitabine, oxaliplatin), fOLFIRI (5-FU, leucovorin, irinotecan), fLOT (5-FU, leucovorin, oxaliplatin, docetaxel), fluorouracil (5-FU) and other drugs in pancreatic cancer, run by Gruppo Oncologico del Nord-Ovest, now recruiting.","summary":"Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLFIRINOX as 1st Line Chemotherapy in Patients With Advanced Pancreatic Cancer. is a phase 3, randomised interventional study registered as NCT06897644 by Gruppo Oncologico del Nord-Ovest, with a registry enrolment figure of 340 participants, started 2025-03-27 and due to reach its primary completion in 2029-01-01. Interventions recorded: Oxaliplatin; Irinotecan (CPT-11); Leucovorin; 5-FU (5-fluorouracil); gemcitabine; Nab-paclitaxel. Conditions listed: Pancreatic Adenocarcinoma Advanced or Metastatic. Primary outcome: Overall Survival (OS). Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic adenocarcinoma eligible for treatment in the first-line setting\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06897644","url":"https://clinicaltrials.gov/study/NCT06897644"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capox","folfiri","flot","fluorouracil","gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06897644","phase":"3","setting":"Gemcitabine Plus Nab-PAclitaxel as Switch maiNTEnance Versus cONtinuation of Modified FOLFIRINOX as First-line Chemotherapy in Patients With Advanced Pancreatic Cancer: the PANThEON Phase III Trial","sponsor":"Gruppo Oncologico del Nord-Ovest","started":"2025-03-27","startedType":"actual","enrolled":340,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05841420","kind":"trial","name":"Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of gemcitabine and nab-paclitaxel in pancreatic cancer, run by Morten Ladekarl, now recruiting.","summary":"Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer is a phase 2, randomised interventional study registered as NCT05841420 by Morten Ladekarl, with a registry enrolment figure of 98 participants, started 2023-06-12 and due to reach its primary completion in 2025-06. Interventions recorded: Gemcitabine; Nab paclitaxel. Conditions listed: Pancreas Cancer; Non-Resectable Pancreas Carcinoma. Primary outcome: PFS (Progression Free Survival). Pancreatic eligibility wording from the registry: \"* Adenocarcinoma of the pancreas, histopathologically or cytologically verified\". Sites: Denmark. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05841420","url":"https://clinicaltrials.gov/study/NCT05841420"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05841420","phase":"2","setting":"A Randomized Phase II Study of Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer","sponsor":"Morten Ladekarl","started":"2023-06-12","startedType":"actual","enrolled":98,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07599995","kind":"trial","name":"Gemcitabine-Cisplatin Plus Envafolimab in Resectable Biliary Tract Malignancies","aka":["GENE"],"tldr":"A phase 2 trial of envafolimab, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by Sir Run Run Shaw Hospital, not yet recruiting.","summary":"Gemcitabine-Cisplatin Plus Envafolimab in Resectable Biliary Tract Malignancies is a phase 2 interventional study registered as NCT07599995 by Sir Run Run Shaw Hospital, with a registry enrolment figure of 34 participants, started 2026-05-30 and due to reach its primary completion in 2028-03-30. Interventions recorded: Neoadjuvant therapy followed by surgery. Conditions listed: Biliary Tract Cancer. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07599995","url":"https://clinicaltrials.gov/study/NCT07599995"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["envafolimab","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07599995","phase":"2","setting":"The Efficacy and Safety of Gemcitabine-Cisplatin Plus Envafolimab as Neoadjuvant Therapy in Resectable Biliary Tract Malignancies at High Risk of Recurrence","sponsor":"Sir Run Run Shaw Hospital","started":"2026-05-30","startedType":"estimated","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06423326","kind":"trial","name":"Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of cisplatin, gemcitabine and nab-paclitaxel in pancreatic cancer, run by Emory University, now recruiting.","summary":"Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer is a phase 2, interventional study registered as NCT06423326 by Emory University, with a registry enrolment figure of 36 participants, started 2024-08-06 and due to reach its primary completion in 2026-12-31. Interventions recorded: Biopsy; Biospecimen Collection; Cisplatin; Computed Tomography; Gemcitabine; Magnetic Resonance Imaging; Nab-paclitaxel; Pancreatic Surgical Procedure. Conditions listed: Borderline Resectable Pancreatic Ductal Adenocarcinoma; Resectable Pancreatic Adenocarcinoma; Stage I Pancreatic Cancer AJCC v8; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8. Primary outcome: Clinical Response Rate to Neoadjuvant Chemotherapy. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed - resectable and borderline resectable pancreatic ductal adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06423326","url":"https://clinicaltrials.gov/study/NCT06423326"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin","gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06423326","phase":"2","setting":"A Single-Arm Phase II Clinical Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma","sponsor":"Emory University","started":"2024-08-06","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"gap-phase2-mdacc","kind":"trial","name":"Gemcitabine, cisplatin and nab-paclitaxel phase 2 (MD Anderson and Mayo)","aka":["GAP phase 2"],"tldr":"The 60-patient study that made the chemotherapy triplet look promising in bile duct and gallbladder cancer: nearly half responded and median survival was 19 months, results that the larger S1815 trial later failed to confirm.","summary":"This open-label single-arm phase 2 (NCT02392637) at MD Anderson and Mayo Clinic Arizona enrolled 62 patients with advanced biliary tract cancer between 2015 and 2017; of 60 treated, 63 percent had intrahepatic cholangiocarcinoma, 15 percent extrahepatic and 22 percent gallbladder cancer, and 78 percent had metastatic disease. Starting doses of gemcitabine 1,000, cisplatin 25 and nab-paclitaxel 125 mg/m² on days 1 and 8 of 21-day cycles were reduced to 800, 25 and 100 mg/m² after haematological toxicity in the first 32 patients. Median progression-free survival, the primary endpoint, was 11.8 months (95 percent confidence interval 6.0 to 15.6), the partial response rate 45 percent, disease control 84 percent and median overall survival 19.2 months. The figures compared favourably with the 8.0 and 11.7 months of gemcitabine and cisplatin in ABC-02 and led directly to SWOG S1815, which found no survival benefit; the contrast is a reminder that single-arm phase 2 results in selected academic-centre populations overestimate effects.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02392637","url":"https://clinicaltrials.gov/study/NCT02392637"},{"label":"Shroff et al., JAMA Oncology 2019","url":"https://doi.org/10.1001/jamaoncol.2019.0270"}],"tags":["lesson:single-arm-phase-2"],"related":[],"cancers":["gallbladder","cholangiocarcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine-cisplatin","nab-paclitaxel"],"companies":[],"institutions":["md-anderson","mayo-clinic"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-gap-phase2-mdacc-jama-oncol-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02392637","phase":"2","setting":"Advanced biliary tract cancer, first line: gemcitabine, cisplatin and nab-paclitaxel, single arm","sponsor":"M.D. Anderson Cancer Center","result":"Median PFS 11.8 months; partial response 45%; median OS 19.2 months (single arm).","started":"2015-04-02","startedType":"actual","yearReported":2019,"enrolled":62,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Gemcitabine + cisplatin + nab-paclitaxel","n":60,"value":11.8}],"source":"https://doi.org/10.1001/jamaoncol.2019.0270"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Gemcitabine + cisplatin + nab-paclitaxel","n":60,"value":19.2}],"source":"https://doi.org/10.1001/jamaoncol.2019.0270"}]},{"id":"nct07433673","kind":"trial","name":"Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)","aka":["GAP Cemi"],"tldr":"A phase 2 trial of cemiplimab, gemcitabine, cisplatin and nab-paclitaxel in gallbladder cancer and other biliary tract cancers, run by Columbia University, now recruiting.","summary":"Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC) is a phase 2 interventional study registered as NCT07433673 by Columbia University, with a registry enrolment figure of 20 participants, started 2026-08 and due to reach its primary completion in 2028-01. Interventions recorded: Cemiplimab. Conditions listed: Colon and Rectal Cancer. Gallbladder cancer is named in the registry entry: \"* Histologically confirmed diagnosis of biliary tract adenocarcinoma (intra- or extra-hepatic, and gallbladder)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07433673","url":"https://clinicaltrials.gov/study/NCT07433673"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cemiplimab","gemcitabine","cisplatin","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07433673","phase":"2","setting":"A Phase 2 Single-arm Study of Cemiplimab, Added to Typical Chemotherapy (Gemcitabine, Cisplatin, Nab-paclitaxel) for Down-staging of Locally Advanced, Unresectable Biliary Tract Cancer","sponsor":"Columbia University","started":"2026-08","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06576115","kind":"trial","name":"Gemcitabine, Nab-paclitaxel Plus the TheraBionic P1 (an Amplitude-Modulated Radiofrequency Electromagnetic Fields) Device to Treat Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of nab-paclitaxel and gemcitabine in pancreatic cancer, run by Barbara Ann Karmanos Cancer Institute, now recruiting.","summary":"Gemcitabine, Nab-paclitaxel Plus the TheraBionic P1 (an Amplitude-Modulated Radiofrequency Electromagnetic Fields) Device to Treat Metastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT06576115 by Barbara Ann Karmanos Cancer Institute, with a registry enrolment figure of 30 participants, started 2025-02-28 and due to reach its primary completion in 2027-07. Interventions recorded: Nab paclitaxel; Gemcitabine; TheraBionic P1. Conditions listed: Metastatic Pancreatic Adenocarcinoma. Primary outcome: 6 Month Progression-Free Survival Rate (PFS 6). Pancreatic eligibility wording from the registry: \"* Patients must have histologically or cytologically proven advanced metastatic adenocarcinoma of the pancreas\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06576115","url":"https://clinicaltrials.gov/study/NCT06576115"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["nab-paclitaxel","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06576115","phase":"2","setting":"Treatment of Patients With Metastatic Pancreatic Cancer With Gemcitabine and Nab-Paclitaxel and Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF)","sponsor":"Barbara Ann Karmanos Cancer Institute","started":"2025-02-28","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"gemstone-301","kind":"trial","name":"GEMSTONE-301","aka":[],"tldr":"Extended the PACIFIC idea to people who could not have chemotherapy and radiotherapy at the same time, the majority in much of the world.","summary":"PACIFIC established consolidation immunotherapy after concurrent chemoradiotherapy, but a substantial proportion of patients with stage III disease cannot tolerate or cannot access concurrent treatment and receive the two sequentially instead. GEMSTONE-301 tested whether consolidation still works in that population. It randomised 381 of 564 screened patients 2:1 at 50 Chinese centres between August 2018 and December 2020 to sugemalimab, an anti-PD-L1 antibody, or placebo, stratified by performance status, whether chemoradiotherapy was concurrent or sequential, and radiotherapy dose.\n\nAt the March 2021 cutoff, with a median follow-up of 14.3 months on sugemalimab and 13.7 on placebo, blinded independently reviewed progression-free survival was significantly longer with sugemalimab: median 9.0 months (95 percent confidence interval 8.1 to 14.1) against 5.8 months.\n\nThe trial matters because it is the only phase 3 evidence for consolidation after sequential chemoradiotherapy, and because sugemalimab is approved in China for this indication. It has no marketing authorisation for stage III disease in the United Kingdom, where NICE TA798 covers durvalumab after platinum-based chemoradiation instead.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03728556","url":"https://clinicaltrials.gov/study/NCT03728556"},{"label":"GEMSTONE-301 (Lancet Oncology 2022)","url":"https://doi.org/10.1016/S1470-2045(21)00630-6"}],"tags":[],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":["pdl1"],"drugs":["sugemalimab"],"companies":["cstone"],"institutions":[],"pathways":[],"terms":["chemoradiation","consolidation-therapy"],"trials":["pacific","pacific-2"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03728556","phase":"3","setting":"Locally advanced unresectable stage III non-small-cell lung cancer in China without progression after either concurrent or sequential chemoradiotherapy: sugemalimab 1200 mg or placebo every three weeks for up to 24 months, with progression-free survival by blinded independent central review as the primary endpoint","sponsor":"CStone Pharmaceuticals","result":"Median progression-free survival 9.0 against 5.8 months by blinded independent review, including after sequential chemoradiotherapy.","started":"2018-10-26","startedType":"actual","yearReported":2022,"enrolled":381,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (blinded independent central review)","primary":true,"unit":"months","arms":[{"name":"Sugemalimab","n":255,"value":9},{"name":"Placebo","n":126,"value":5.8}],"source":"https://doi.org/10.1016/S1470-2045(21)00630-6"}],"replication":"PACIFIC showed the same effect after concurrent chemoradiotherapy with durvalumab; GEMSTONE-301 is the extension to sequential treatment."},{"id":"gemstone-302","kind":"trial","name":"GEMSTONE-302","aka":[],"tldr":"The trial behind sugemalimab's approval in China and later Europe, showing a PD-L1 antibody plus chemotherapy delays progression in both main types of lung cancer.","summary":"479 patients randomised 2:1. Median progression-free survival 7.8 versus 4.9 months (hazard ratio 0.50) at the interim analysis, with benefit in squamous and non-squamous histology and across PD-L1 levels; overall survival favoured sugemalimab at the final analysis. NMPA approval December 2021; European Commission approval July 2024, the first EU approval of a Chinese-developed PD-L1 antibody.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03789604","url":"https://clinicaltrials.gov/study/NCT03789604"},{"label":"Lancet Oncol 2022","url":"https://doi.org/10.1016/S1470-2045(21)00650-1"}],"tags":["china"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sugemalimab"],"companies":["cstone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["zhou-caicun"],"bottlenecks":[],"keyPapers":["paper-gemstone-302-lancet-oncol-2022","paper-gemstone-302-nat-cancer-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03789604","phase":"3","setting":"First-line metastatic squamous and non-squamous NSCLC without EGFR, ALK, ROS1 or RET alterations, China: sugemalimab or placebo plus platinum chemotherapy","sponsor":"CStone Pharmaceuticals","result":"PFS 7.8 vs 4.9 months, HR 0.50.","started":"2018-12-13","startedType":"actual","yearReported":2022,"enrolled":479,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Sugemalimab + chemotherapy","n":320,"value":7.8},{"name":"Placebo + chemotherapy","n":159,"value":4.9}],"hr":0.5,"source":"https://doi.org/10.1016/S1470-2045(21)00650-1"}]},{"id":"nct04093505","kind":"trial","name":"Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia)","aka":[],"tldr":"A phase 3 trial of Glasdegib in Acute myeloid leukaemia, run by University Hospital Heidelberg, recorded as terminated on the registry.","summary":"Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia) is a phase 3 interventional study registered as NCT04093505 by University Hospital Heidelberg, with 28 participants recorded, started 2021-04-01 and due to reach its primary completion in 2022-06-15. Interventions recorded: Gemtuzumab Ozogamicin 147, Gemtuzumab Ozogamicin 1, Glasdegib, Placebo Oral Tablet. Conditions recorded: Acute Myeloid Leukemia.\n\nLinked to the drug Glasdegib because the registry names it among its interventions and Acute myeloid leukaemia among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04093505","url":"https://clinicaltrials.gov/study/NCT04093505"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-older-unfit"],"sections":[],"technologies":[],"targets":[],"drugs":["glasdegib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04093505","phase":"3","setting":"Randomized Phase-III Study to Compare Two Schedules of Gemtuzumab Ozogamicin as Adjunct to Intensive Induction Therapy and to Compare Intensive Postremission Therapy Double Blinded With or Without Glasdegib in Older Patients With Newly Diagnosed AML","sponsor":"University Hospital Heidelberg","started":"2021-04-01","startedType":"actual","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04083599","kind":"trial","name":"GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab, Cisplatin, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Genmab, active and no longer recruiting.","summary":"GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors is a phase 1/2 interventional study registered as NCT04083599 by Genmab, with 350 participants enrolled, started 2019-09-17 and due to reach its primary completion in 2025-12-30. Interventions recorded: GEN1042, Pembrolizumab, Cisplatin, Carboplatin, 5-FU. Conditions listed: Malignant Solid Tumor, Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04083599","url":"https://clinicaltrials.gov/study/NCT04083599"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","colorectal","melanoma","head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","cisplatin","carboplatin","flot","gemcitabine","paclitaxel"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04083599","phase":"1/2","setting":"A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors","sponsor":"Genmab","started":"2019-09-17","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06533579","kind":"trial","name":"Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)","aka":["SENTRY-CD19"],"tldr":"A phase 1/2 trial of Dose Level 1, VNX-101 in acute lymphoblastic leukaemia, diffuse large B-cell lymphoma, chronic lymphocytic leukaemia, non-Hodgkin lymphoma, follicular lymphoma and mantle cell lymphoma, run by Vironexis Biotherapeutics Inc., now recruiting.","summary":"Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19) is a phase 1/2 interventional study registered as NCT06533579 by Vironexis Biotherapeutics Inc., with 32 participants planned, started 2025-05-30 and due to reach its primary completion in 2027-06. Interventions recorded: Dose Level 1, VNX-101, Dose Level 2, VNX-101, Dose Level 3, VNX-101 and Dose Level 4, VNX-101.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06533579","url":"https://clinicaltrials.gov/study/NCT06533579"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","dlbcl","cll","non-hodgkin-lymphoma","follicular-lymphoma","mantle-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["vironexis-biotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06533579","phase":"1/2","setting":"A Phase 1/2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)","sponsor":"Vironexis Biotherapeutics Inc.","started":"2025-05-30","startedType":"actual","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07192432","kind":"trial","name":"Gene Therapy for HER-Positive Cancer (SENTRY-HER2)","aka":["SENTRY-HER2"],"tldr":"A phase 1/2 trial of Dose Level 1, VNX-202 in advanced solid tumours, run by Vironexis Biotherapeutics Inc., now recruiting.","summary":"Gene Therapy for HER-Positive Cancer (SENTRY-HER2) is a phase 1/2 interventional study registered as NCT07192432 by Vironexis Biotherapeutics Inc., with 27 participants planned, started 2025-11-18 and due to reach its primary completion in 2033-09. Interventions recorded: Dose Level 1, VNX-202, Dose Level 2, VNX-202, Dose Level 3, VNX-202 and Dose Level 4, VNX-202.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07192432","url":"https://clinicaltrials.gov/study/NCT07192432"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["her2"],"drugs":[],"companies":["vironexis-biotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07192432","phase":"1/2","setting":"A Phase 1/2, First-in-Human Study of VNX-202 Gene Therapy in Patients With HER2-Positive Cancer","sponsor":"Vironexis Biotherapeutics Inc.","started":"2025-11-18","startedType":"actual","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07730125","kind":"trial","name":"Gene-edited T Regulatory Cells (CRG-150) for the Treatment of Relapsed/Refractory Malignancies","aka":[],"tldr":"A phase 1/2 trial in triple-negative breast cancer, run by CoRegen, Inc., not yet recruiting.","summary":"Gene-edited T Regulatory Cells (CRG-150) for the Treatment of Relapsed/Refractory Malignancies is a phase 1/2, interventional study registered as NCT07730125 by CoRegen, Inc., with a registry enrolment figure of 67 participants, started 2026-11 and due to reach its primary completion in 2029-06. Interventions recorded: CRG-150. Conditions listed: HR-positive, HER2-negative Breast Cancer; TNBC - Triple-Negative Breast Cancer; Prostate Cancer. Triple-negative eligibility wording from the registry: \"TNBC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07730125","url":"https://clinicaltrials.gov/study/NCT07730125"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07730125","phase":"1/2","setting":"Gene-edited T Regulatory Cells (CRG-150) for the Treatment of Relapsed/Refractory Malignancies","sponsor":"CoRegen, Inc.","started":"2026-11","startedType":"estimated","enrolled":67,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05528133","kind":"trial","name":"Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by H. Lee Moffitt Cancer Center and Research Institute, now recruiting.","summary":"Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer is a phase 2, interventional study registered as NCT05528133 by H. Lee Moffitt Cancer Center and Research Institute, with a registry enrolment figure of 86 participants, started 2023-01-25 and due to reach its primary completion in 2028-05. Interventions recorded: Genomically Guided Radiation Therapy; Genomically Guided Radiation Therapy. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Confirmation of Triple Negative (TN) breast cancer by tissue biopsy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05528133","url":"https://clinicaltrials.gov/study/NCT05528133"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05528133","phase":"2","setting":"Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","started":"2023-01-25","startedType":"actual","enrolled":86,"enrolledBasis":"registry","outcomes":[]},{"id":"geometry-mono-1","kind":"trial","name":"GEOMETRY mono-1","aka":[],"tldr":"GEOMETRY mono-1 showed that capmatinib shrinks two thirds of untreated lung cancers with a MET exon 14 skipping mutation and about four in ten after chemotherapy, which made MET exon 14 the seventh lung cancer driver with an approved targeted drug.","summary":"GEOMETRY mono-1 enrolled patients with advanced non-small-cell lung cancer into cohorts defined by MET exon 14 skipping or by the degree of MET amplification and by prior treatment, all receiving capmatinib 400 mg twice daily. MET exon 14 skipping, found in 3 to 4 percent of lung cancers and often in older patients and sarcomatoid tumours, had responded poorly to the multikinase inhibitor crizotinib.\n\nAmong the exon 14 cohorts the response rate was 68 percent in 28 treatment-naive patients and 41 percent in 69 previously treated patients, with median durations of response of 12.6 and 9.7 months and activity against brain metastases. Tumours with high MET amplification (gene copy number 10 or more) responded in about a third of cases; lower levels of amplification did not respond. Peripheral oedema and nausea were the main side effects.\n\nThe FDA granted accelerated approval in May 2020 and regular approval in 2022; tepotinib (VISION) followed with similar results, and the two drugs are interchangeable options.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02414139","url":"https://clinicaltrials.gov/study/NCT02414139"},{"label":"New England Journal of Medicine 2020","url":"https://doi.org/10.1056/NEJMoa2002787"}],"tags":[],"related":[],"cancers":["nsclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["met"],"drugs":["capmatinib","crizotinib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":["met-amplification"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-wolf-geometry-mono-1-capmatinib-nejm-2020","paper-geometry-mono-1-lancet-oncol-2024-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02414139","phase":"2","setting":"Advanced non-small-cell lung cancer with MET exon 14 skipping or MET amplification: capmatinib monotherapy in cohorts by prior treatment and MET gene copy number","sponsor":"Novartis","result":"Response rate 68% (treatment-naive, n=28) and 41% (previously treated, n=69) in MET exon 14 skipping disease; about a third in high-level MET amplification.","started":"2015-06-11","startedType":"actual","yearReported":2020,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate, MET exon 14 skipping","primary":true,"unit":"%","arms":[{"name":"Treatment-naive","n":28,"value":68},{"name":"Previously treated","n":69,"value":41}],"source":"https://doi.org/10.1056/NEJMoa2002787"}],"replication":"VISION (tepotinib) reported a 46 percent response rate in the same population and both drugs are approved."},{"id":"gepardouze","kind":"trial","name":"GeparDouze / NSABP B-59","aka":["NSABP B-59","GBG 96","GeparDouze"],"tldr":"GeparDouze, the largest neoadjuvant immunotherapy trial in triple-negative breast cancer, found that adding atezolizumab to chemotherapy before and after surgery did not significantly reduce relapses (a 3.3-point gain at four years that missed statistical significance), unlike pembrolizumab in KEYNOTE-522.","summary":"NSABP B-59/GeparDouze (NCT03281954) randomised 1,550 patients (773 atezolizumab, 777 placebo) with stage II to III triple-negative breast cancer to sequential taxane, carboplatin and anthracycline neoadjuvant chemotherapy with atezolizumab or placebo, continued after surgery. The primary endpoint, event-free survival, was not significantly improved (hazard ratio 0.80, 95 percent confidence interval 0.62 to 1.03, stratified log-rank p 0.083; four-year rates differed by 3.3 points); the overall survival hazard ratio was 0.86 (0.62 to 1.19) with a 0.7-point four-year difference. A prespecified subgroup analysis suggested benefit in patients with clinical nodal involvement (interaction p 0.039), and an exploratory mRNA analysis pointed to basal-like immune-activated tumours. Grade 3 or worse treatment-emergent adverse events were 75.3 versus 73.4 percent and immune-related adverse events 27.6 versus 11.4 percent; 25.5 percent discontinued atezolizumab in the neoadjuvant phase against 18.8 percent for placebo. Published in Nature Medicine in 2026, the trial leaves pembrolizumab as the only checkpoint inhibitor with an early-stage triple-negative licence.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03281954","url":"https://clinicaltrials.gov/study/NCT03281954"},{"label":"Geyer, Loibl et al., Nature Medicine 2026: atezolizumab in early triple-negative breast cancer, NSABP B-59/GeparDouze","url":"https://doi.org/10.1038/s41591-026-04565-6"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","platinum","cytotoxic-chemotherapy"],"targets":[],"drugs":["atezolizumab","carboplatin","paclitaxel","doxorubicin","epirubicin","cyclophosphamide"],"companies":["roche-genentech","gbg"],"institutions":[],"pathways":[],"terms":["efs","irae","tils"],"trials":["keynote-522","neotrip","impassion030","impassion031"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03281954","phase":"3","setting":"Stage II to III triple-negative breast cancer: neoadjuvant taxane, carboplatin and anthracycline chemotherapy with atezolizumab or placebo, then adjuvant atezolizumab or placebo, United States, Canada and Germany","sponsor":"NSABP Foundation / German Breast Group, with Genentech and Roche","result":"EFS HR 0.80 (0.62 to 1.03), p 0.083, not significant; OS HR 0.86 (0.62 to 1.19).","started":"2017-12-19","startedType":"actual","yearReported":2026,"enrolled":1550,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival (four-year difference 3.3 points)","primary":true,"arms":[{"name":"Atezolizumab + chemotherapy","n":773},{"name":"Placebo + chemotherapy","n":777}],"hr":0.8,"ci":[0.62,1.03],"p":"0.083","source":"https://doi.org/10.1038/s41591-026-04565-6"},{"endpoint":"Overall survival (four-year difference 0.7 points)","arms":[{"name":"Atezolizumab + chemotherapy"},{"name":"Placebo + chemotherapy"}],"hr":0.86,"ci":[0.62,1.19],"source":"https://doi.org/10.1038/s41591-026-04565-6"}],"replication":"Consistent with NeoTRIP (no pCR gain) and ALEXANDRA/IMpassion030 (adjuvant, futile); discordant with KEYNOTE-522 (pembrolizumab, EFS HR 0.63)."},{"id":"geparsixto","kind":"trial","name":"GeparSixto","aka":["GBG 66"],"tldr":"GeparSixto showed that adding carboplatin to chemotherapy given before surgery made triple-negative breast tumours disappear completely far more often, and in longer follow-up cut relapses, which put platinum into the standard neoadjuvant regimen for this type.","summary":"GeparSixto randomised 595 women with early triple-negative or HER2-positive breast cancer to 18 weeks of weekly paclitaxel and non-pegylated liposomal doxorubicin, with bevacizumab for triple-negative and trastuzumab plus lapatinib for HER2-positive disease, with or without weekly carboplatin. The primary endpoint was pathological complete response.\n\nCarboplatin increased the pathological complete response rate in triple-negative disease, and in longer follow-up improved disease-free survival in that group, but did not help HER2-positive disease and added haematological toxicity. Together with CALGB 40603 and later BrighTNess it established carboplatin as part of neoadjuvant chemotherapy for triple-negative breast cancer, the backbone that KEYNOTE-522 then added pembrolizumab to.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01426880","url":"https://clinicaltrials.gov/study/NCT01426880"},{"label":"GeparSixto survival and HRD analysis (Annals of Oncology 2018)","url":"https://doi.org/10.1093/annonc/mdy460"}],"tags":["subtype-trials"],"related":[],"cancers":["tnbc-early","tnbc","breast-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","paclitaxel","doxorubicin","bevacizumab","trastuzumab","lapatinib"],"companies":["gbg"],"institutions":[],"pathways":[],"terms":[],"trials":["brightness","calgb-40603","keynote-522"],"people":["gunter-von-minckwitz"],"bottlenecks":[],"keyPapers":["paper-hahnen-geparsixto-germline-brca-jama-oncol-2017","paper-loibl-geparsixto-survival-hrd-ann-oncol-2018","paper-geparsixto-lancet-oncol-2014"],"journals":[],"dependsOn":[],"notes":["Survival analysis (Annals of Oncology 2018, median follow-up 47.3 months): disease-free survival hazard ratio 0.56 (0.34 to 0.93, p 0.022) with carboplatin in triple-negative disease, overall survival not significantly improved, no benefit in HER2-positive disease. Homologous recombination deficiency was found in 70.5 percent of 193 triple-negative tumours and predicted pathological complete response (odds ratio 2.60) but not carboplatin benefit; pathological complete response rose from 33.9 to 63.5 percent with carboplatin in HR-deficient tumours and from 20.0 to 29.6 percent in HR-proficient ones."],"nct":"NCT01426880","phase":"2/3","setting":"Early triple-negative and HER2-positive breast cancer: neoadjuvant paclitaxel and non-pegylated liposomal doxorubicin (with bevacizumab in triple-negative and trastuzumab plus lapatinib in HER2-positive disease) with or without carboplatin","sponsor":"German Breast Group (GBG Forschungs GmbH)","result":"Carboplatin increased pathological complete response and improved disease-free survival in triple-negative breast cancer, without benefit in HER2-positive disease.","started":"2011-08","yearReported":2014,"enrolled":595,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathological complete response (ypT0 ypN0), all patients","primary":true,"unit":"%","arms":[{"name":"Carboplatin added to neoadjuvant therapy","n":295,"value":43.7,"note":"Odds ratio 1.33 (95% CI 0.96 to 1.85)"},{"name":"No carboplatin","n":293,"value":36.9}],"p":"0.107","source":"https://doi.org/10.1016/s1470-2045(14)70160-3"},{"endpoint":"Pathological complete response, triple-negative breast cancer","unit":"%","arms":[{"name":"Carboplatin added to neoadjuvant therapy","n":158,"value":53.2},{"name":"No carboplatin","n":157,"value":36.9}],"p":"0.005","source":"https://doi.org/10.1016/s1470-2045(14)70160-3"},{"endpoint":"Pathological complete response, HER2-positive breast cancer","unit":"%","arms":[{"name":"Carboplatin added to neoadjuvant therapy","n":137,"value":32.8},{"name":"No carboplatin","n":136,"value":36.8}],"p":"0.581","source":"https://doi.org/10.1016/s1470-2045(14)70160-3"},{"endpoint":"Grade 3-4 neutropenia","unit":"%","arms":[{"name":"Carboplatin added to neoadjuvant therapy","n":295,"value":65},{"name":"No carboplatin","n":293,"value":27}],"source":"https://doi.org/10.1016/s1470-2045(14)70160-3"}]},{"id":"nct06052826","kind":"trial","name":"Geriatric Assessment Guided Interventions to Accelerate Functional Recovery After CAR-T Therapy for Patients 60 Years and Older With B-cell Non-Hodgkin Lymphoma or Multiple Myeloma, GOCART Study","aka":["GOCART"],"tldr":"A phase 2 trial of Geriatric assessment in Non-Hodgkin lymphoma and Multiple myeloma, run by City of Hope Medical Center, now recruiting.","summary":"Geriatric Assessment Guided Interventions to Accelerate Functional Recovery After CAR-T Therapy for Patients 60 Years and Older With B-cell Non-Hodgkin Lymphoma or Multiple Myeloma, GOCART Study is a phase 2 interventional study registered as NCT06052826 by City of Hope Medical Center, with 164 participants planned, started 2023-06-23 and due to reach its primary completion in 2026-10-05. Interventions recorded: Best Practice, Cognitive Intervention, Comprehensive Geriatric Assessment, Nutritional Intervention, Physical Therapy, Questionnaire Administration. Conditions recorded: B-Cell Non-Hodgkin Lymphoma, Multiple Myeloma.\n\nLinked to the technology Geriatric assessment because the registry names it (\"geriatric assessment\") among its interventions and Non-Hodgkin lymphoma and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06052826","url":"https://clinicaltrials.gov/study/NCT06052826"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","multiple-myeloma"],"sections":[],"technologies":["geriatric-assessment"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06052826","phase":"2","setting":"Geriatric (G) Assessment Guided Optimization (O) to Accelerate Functional Recovery After Chimeric Antigen Receptor T-Cell (CAR-T) Therapy for Patients 60 Years and Older With B-Cell Non-Hodgkin Lymphoma or Multiple Myeloma (GOCART)","sponsor":"City of Hope Medical Center","started":"2023-06-23","startedType":"actual","enrolled":164,"enrolledBasis":"registry","outcomes":[]},{"id":"getug-13","kind":"trial","name":"GETUG 13","aka":["GETUG-13","GETUG13"],"tldr":"GETUG 13 showed that men with the worst-risk testicular cancers whose tumour markers fall too slowly after the first cycle of chemotherapy do better if treatment is intensified: 59 percent were free of progression at three years against 48 percent with standard BEP, and fewer needed high-dose salvage chemotherapy.","summary":"GETUG 13 was a phase 3 trial of the French GETUG group with MD Anderson and Slovak centres in 263 patients with poor-prognosis (IGCCCG) non-seminomatous germ cell tumours. After one cycle of bleomycin, etoposide and cisplatin, the 203 patients with an unfavourable decline in alpha-fetoprotein and hCG were randomised to three further BEP cycles or a dose-dense regimen (paclitaxel-BEP-oxaliplatin followed by cisplatin, ifosfamide and bleomycin with growth factor support); the 51 with a favourable decline continued BEP. The primary endpoint was progression-free survival.\n\nThree-year progression-free survival was 59 percent with dose-dense chemotherapy against 48 percent with BEP (hazard ratio 0.66, p 0.05), with more grade 3 to 4 neurotoxicity and haematological toxicity but no difference in toxic deaths, and fewer patients needed salvage high-dose chemotherapy (6 against 16 percent). Marker-guided intensification became the approach for poor-prognosis disease, which is how the corpus's testicular cancer page cites the trial.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00104676","url":"https://clinicaltrials.gov/study/NCT00104676"}],"tags":["soc-trials"],"related":[],"cancers":["non-seminoma","testicular"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["bleomycin","etoposide","cisplatin","paclitaxel","oxaliplatin","ifosfamide"],"companies":["unicancer"],"institutions":["md-anderson"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-getug-13-marker-guided-dose-dense-chemotherapy-fizazi-lancet-oncol-2014"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00104676","phase":"3","setting":"Poor-prognosis disseminated non-seminomatous germ cell tumours in France, the United States and Slovakia: after one cycle of BEP, patients with an unfavourable tumour marker decline were randomised to continue BEP or switch to dose-dense chemotherapy (paclitaxel-BEP-oxaliplatin then cisplatin, ifosfamide and bleomycin), with progression-free survival as the primary endpoint","sponsor":"UNICANCER","result":"Three-year progression-free survival 59 percent with marker-guided dose-dense chemotherapy against 48 percent with BEP (hazard ratio 0.66, p 0.05); salvage high-dose chemotherapy needed in 6 against 16 percent.","started":"2003-11-26","startedType":"actual","yearReported":2014,"enrolled":263,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 3 years, unfavourable marker decline","primary":true,"unit":"%","arms":[{"name":"Dose-dense chemotherapy (T-BEP-oxaliplatin then cisplatin, ifosfamide, bleomycin)","n":105,"value":59,"note":"95% CI 49 to 68"},{"name":"Standard BEP","n":98,"value":48,"note":"95% CI 38 to 59"}],"hr":0.66,"ci":[0.44,1],"p":"0.05","source":"https://doi.org/10.1016/S1470-2045(14)70490-5"},{"endpoint":"Progression-free survival at 3 years, favourable marker decline (continued BEP, not randomised)","unit":"%","arms":[{"name":"BEP after favourable marker decline","n":51,"value":70,"note":"95% CI 57 to 81"}],"source":"https://doi.org/10.1016/S1470-2045(14)70490-5"},{"endpoint":"Salvage high-dose chemotherapy with stem cell transplant required","unit":"%","arms":[{"name":"Dose-dense chemotherapy","n":105,"value":6},{"name":"Standard BEP","n":98,"value":16}],"source":"https://doi.org/10.1016/S1470-2045(14)70490-5"},{"endpoint":"Grade 3 to 4 neurotoxicity","unit":"%","arms":[{"name":"Dose-dense chemotherapy","n":105,"value":7},{"name":"Standard BEP","n":98,"value":1}],"source":"https://doi.org/10.1016/S1470-2045(14)70490-5"}]},{"id":"getug-afu-15","kind":"trial","name":"GETUG-AFU 15","aka":["GETUG-AFU 15","GETUG 15"],"tldr":"The first trial to test chemotherapy at the start of hormone therapy for metastatic prostate cancer found no benefit. It was too small, and CHAARTED and STAMPEDE later showed it had missed a real effect.","summary":"GETUG-AFU 15 randomised 385 men with metastatic non-castrate prostate cancer to androgen deprivation alone or with docetaxel 75 mg/m2 every 21 days for up to nine cycles. At a median 50 months, median overall survival was 58.9 months (95 percent confidence interval 50.8 to 69.1) with docetaxel and 54.2 months (42.2 to not reached) without, hazard ratio 1.01 (0.75 to 1.36). The authors concluded that docetaxel should not be used first line in this setting.\n\nThat conclusion was wrong, and the reason is instructive. The trial had 385 men where CHAARTED had 790 and the STAMPEDE docetaxel comparison had nearly 3,000, and a substantial proportion of GETUG-AFU 15 patients had low-volume disease, the group in which docetaxel has since been shown to add least. Later analyses of GETUG-AFU 15 with longer follow-up found a benefit concentrated in high-volume disease, matching CHAARTED.\n\nThe toxicity it reported is real and still applies: 72 serious adverse events with docetaxel, most commonly neutropenia in 40 men (21 percent), febrile neutropenia in six (3 percent), abnormal liver function tests in three (2 percent) and neutropenia with infection in two (1 percent). Four treatment-related deaths occurred, two of them from neutropenia, after which the data monitoring committee recommended granulocyte colony-stimulating factor and no further treatment-related deaths occurred. None were reported in the androgen deprivation arm.\n\nGETUG-AFU 15 is the clearest example in prostate cancer of a trial that was negative because it was underpowered, not because the drug does not work, and it is the reason the field now insists on volume-stratified analysis in this setting.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00104715","url":"https://clinicaltrials.gov/study/NCT00104715"},{"label":"GETUG-AFU 15 (Lancet Oncology 2013)","url":"https://doi.org/10.1016/S1470-2045(12)70560-0"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["cytotoxic-chemotherapy","androgen-deprivation"],"targets":[],"drugs":["docetaxel"],"companies":["unicancer","sanofi"],"institutions":[],"pathways":[],"terms":["adt","mcrpc-mhspc","hormone-therapy"],"trials":["chaarted","stampede"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00104715","phase":"3","setting":"Metastatic non-castrate (hormone-sensitive) prostate adenocarcinoma with radiologically proven metastases and a Karnofsky score of at least 70: androgen deprivation alone against androgen deprivation with up to nine cycles of docetaxel 75 mg/m2 every 21 days, with overall survival as the primary endpoint","sponsor":"UNICANCER, funded by the French Health Ministry, Institut National du Cancer, Sanofi-Aventis, AstraZeneca and Amgen","result":"Median overall survival 58.9 against 54.2 months (hazard ratio 1.01, 95 percent confidence interval 0.75 to 1.36); no benefit found, but the trial was underpowered and CHAARTED and STAMPEDE later found one.","started":"2004-10-18","startedType":"actual","yearReported":2013,"enrolled":385,"enrolledBasis":"randomised","enrolledNote":"385 men were randomised at 29 centres in France and one in Belgium, 192 to androgen deprivation with docetaxel and 193 to androgen deprivation alone.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Androgen deprivation with docetaxel","n":192,"value":58.9},{"name":"Androgen deprivation alone","n":193,"value":54.2}],"hr":1.01,"ci":[0.75,1.36],"source":"https://doi.org/10.1016/S1470-2045(12)70560-0"},{"endpoint":"Grade 3 or worse neutropenia","unit":"%","arms":[{"name":"Androgen deprivation with docetaxel","n":192,"value":21,"note":"Reported as serious adverse events; febrile neutropenia in 3 percent and four treatment-related deaths."}],"source":"https://doi.org/10.1016/S1470-2045(12)70560-0"}],"replication":"Contradicted by CHAARTED (790 men, overall survival hazard ratio 0.61) and by the STAMPEDE docetaxel comparison; the discrepancy resolves on metastatic volume and sample size."},{"id":"getug-afu-16","kind":"trial","name":"GETUG-AFU 16","aka":["GETUG-AFU 16","GETUG 16"],"tldr":"Adding six months of hormone therapy to radiotherapy given for a rising PSA after prostate surgery raised the proportion free of progression at ten years from about half to about two thirds.","summary":"GETUG-AFU 16 randomised 743 men whose PSA had risen from 0.1 to between 0.2 and 2.0 ng/mL after radical prostatectomy to salvage radiotherapy alone or salvage radiotherapy with short-term androgen suppression, given as 10.8 mg subcutaneous goserelin on the first day of irradiation and 3 months later. Radiotherapy was 66 Gy in 33 fractions, five days a week for 7 weeks, by three-dimensional conformal or intensity-modulated technique.\n\nAt the March 2019 cutoff, median follow-up 112 months, 120-month progression-free survival was 64 percent (95 percent confidence interval 58 to 69) with radiotherapy plus goserelin and 49 percent (43 to 54) with radiotherapy alone, hazard ratio 0.54 (0.43 to 0.68, stratified log-rank p<0.0001). Two secondary cancers occurred after the primary analysis and neither was considered treatment related. There were no treatment-related deaths.\n\nThe trial answers a narrow and practical question. It does not tell a man whether 6 months is the right duration, which RADICALS-HD addressed with a 6 against 24 month comparison, nor whether the pelvic nodes should be treated, which SPPORT addressed.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00423475","url":"https://clinicaltrials.gov/study/NCT00423475"},{"label":"GETUG-AFU 16 at 112 months (Lancet Oncology 2019)","url":"https://doi.org/10.1016/S1470-2045(19)30486-3"}],"tags":[],"related":[],"cancers":["prostate","prostate-bcr"],"sections":[],"technologies":["androgen-deprivation","imrt-igrt"],"targets":[],"drugs":["goserelin"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":["adt","salvage-therapy","biochemical-recurrence","prostatectomy"],"trials":["rtog-9601","nct00567580","radicals-hd"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00423475","phase":"3","setting":"Rising PSA between 0.2 and 2.0 ng/mL after radical prostatectomy for pT2, pT3 or pT4a pN0 or pNx disease, without previous androgen suppression or pelvic radiotherapy: salvage radiotherapy of 66 Gy in 33 fractions alone against the same with 6 months of goserelin, with progression-free survival as the primary endpoint","sponsor":"UNICANCER, funded by the French Health Ministry, AstraZeneca and la Ligue Contre le Cancer","result":"Progression-free survival at 120 months 64 percent with salvage radiotherapy plus 6 months of goserelin against 49 percent with radiotherapy alone (hazard ratio 0.54, 95 percent confidence interval 0.43 to 0.68).","started":"2006-10","startedType":"actual","yearReported":2019,"enrolled":743,"enrolledBasis":"randomised","enrolledNote":"743 men were randomly assigned between October 2006 and March 2010, 374 to radiotherapy alone and 369 to radiotherapy with goserelin.","outcomes":[{"endpoint":"Progression-free survival at 120 months","primary":true,"unit":"%","arms":[{"name":"Salvage radiotherapy with 6 months of goserelin","n":369,"value":64},{"name":"Salvage radiotherapy alone","n":374,"value":49}],"hr":0.54,"ci":[0.43,0.68],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(19)30486-3"}],"replication":"RTOG 9601 showed the same direction with 24 months of bicalutamide, and SPPORT with 4 to 6 months of androgen deprivation with or without pelvic nodal radiotherapy."},{"id":"getug-afu-17","kind":"trial","name":"GETUG-AFU 17","aka":["GETUG-AFU 17","GETUG 17"],"tldr":"The French version of the same question, and the same answer: treating everyone straight after surgery does not help, and it doubles the rate of lasting bladder and erection problems.","summary":"GETUG-AFU 17 enrolled 424 men at 46 French hospitals with pT3a, pT3b or pT4a disease and positive surgical margins after radical prostatectomy, randomised 1:1 to immediate adjuvant radiotherapy or delayed salvage radiotherapy at biochemical relapse. All men received 6 months of triptorelin. Enrolment was stopped early on the recommendation of the independent data monitoring committee because event rates were unexpectedly low; 718 had been planned.\n\nAt a median 75 months, 205 of 212 men (97 percent) in the adjuvant group started treatment, against 115 of 212 (54 percent) in the salvage group. Five-year event-free survival was 92 percent (95 percent confidence interval 86 to 95) with adjuvant radiotherapy and 90 percent (85 to 94) with salvage, hazard ratio 0.81 (0.48 to 1.36, log-rank p=0.42).\n\nThe toxicity difference was large. Late grade 2 or worse genitourinary adverse events occurred in 58 of 212 men (27 percent) after adjuvant radiotherapy against 14 of 212 (7 percent) after salvage (p<0.0001), and late erectile dysfunction of grade 2 or worse in 60 of 212 (28 percent) against 17 of 212 (8 percent) (p<0.0001). Acute grade 3 or worse effects were rare in both arms, six and four men respectively.\n\nThe authors were candid that the analysis lacked statistical power, which is why the ARTISTIC meta-analysis was designed in advance to pool the three trials.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00667069","url":"https://clinicaltrials.gov/study/NCT00667069"},{"label":"GETUG-AFU 17 (Lancet Oncology 2020)","url":"https://doi.org/10.1016/S1470-2045(20)30454-X"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk","prostate-bcr"],"sections":[],"technologies":["imrt-igrt","androgen-deprivation"],"targets":[],"drugs":["triptorelin"],"companies":["unicancer","ipsen"],"institutions":[],"pathways":[],"terms":["prostatectomy","salvage-therapy","biochemical-recurrence","qol-pro"],"trials":["radicals-rt","raves","artistic-meta-analysis"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00667069","phase":"3","setting":"pT3a, pT3b or pT4a prostate cancer with positive surgical margins after radical prostatectomy: immediate adjuvant radiotherapy against delayed salvage radiotherapy at biochemical relapse, both with 6 months of triptorelin, with event-free survival as the primary endpoint","sponsor":"UNICANCER, funded by the French Health Ministry and Ipsen","result":"Five-year event-free survival 92 percent with adjuvant against 90 percent with salvage radiotherapy (hazard ratio 0.81, 95 percent confidence interval 0.48 to 1.36); late grade 2 or worse genitourinary toxicity 27 against 7 percent and erectile dysfunction 28 against 8 percent.","started":"2008-04-07","startedType":"actual","yearReported":2020,"enrolled":424,"enrolledBasis":"randomised","enrolledNote":"424 of a planned 718 men were enrolled before the independent data monitoring committee recommended early termination because event rates were unexpectedly low.","outcomes":[{"endpoint":"Event-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Adjuvant radiotherapy","n":212,"value":92},{"name":"Delayed salvage radiotherapy","n":212,"value":90}],"hr":0.81,"ci":[0.48,1.36],"p":"0.42","source":"https://doi.org/10.1016/S1470-2045(20)30454-X"},{"endpoint":"Late grade 2 or worse erectile dysfunction","unit":"%","arms":[{"name":"Adjuvant radiotherapy","n":212,"value":28},{"name":"Delayed salvage radiotherapy","n":212,"value":8}],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(20)30454-X"}],"replication":"RADICALS-RT and RAVES found the same, and all three were pooled in ARTISTIC."},{"id":"nct07554859","kind":"trial","name":"GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Genfleet Therapeutics (Shanghai) Inc., not yet recruiting.","summary":"GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer is a phase 2, randomised interventional study registered as NCT07554859 by Genfleet Therapeutics (Shanghai) Inc., with a registry enrolment figure of 90 participants, started 2026-05-20 and due to reach its primary completion in 2027-04-30. Interventions recorded: ArmA:GFH375; Arm B:GFH375; Arm C:GFH375. Conditions listed: NSCLC (Advanced Non-small Cell Lung Cancer). Primary outcome: the efficacy of GFH375 as monotherapy and in combination therapy. Lung eligibility wording from the registry: \"Pathologically (histologically or cytologically) confirmed advanced (Stage IV) or locally advanced non-squamous non-small cell lung cancer that is not amenable to radical surgery or radiotherapy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07554859","url":"https://clinicaltrials.gov/study/NCT07554859"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07554859","phase":"2","setting":"A Multicenter, Open-label, Randomized Clinical Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of GFH375 Monotherapy and Combination Therapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer Harboring KRAS G12D Mutation.","sponsor":"Genfleet Therapeutics (Shanghai) Inc.","started":"2026-05-20","startedType":"estimated","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"hd10","kind":"trial","name":"GHSG HD10","aka":["HD10","Reduced treatment intensity in early-stage Hodgkin lymphoma"],"tldr":"Halving the chemotherapy and cutting the radiation dose by a third worked just as well for early Hodgkin lymphoma with favourable features, and caused fewer side effects.","summary":"HD10 is the trial that set the modern floor for early favourable Hodgkin lymphoma. 1,370 patients with newly diagnosed early-stage disease and a favourable prognosis were randomly assigned to one of four groups: four cycles of ABVD with 30 Gy of involved-field radiotherapy, four cycles with 20 Gy, two cycles with 30 Gy, or two cycles with 20 Gy. The primary endpoint was freedom from treatment failure.\n\nNeither comparison showed a difference. Five-year freedom from treatment failure was 93.0 per cent (95 per cent confidence interval 90.5 to 94.8) with four cycles and 91.1 per cent (88.3 to 93.2) with two (p = 0.39); overall survival did not differ (p = 0.61). The two radiation doses were also indistinguishable (p = 1.00 for freedom from treatment failure, p = 0.61 for overall survival). Adverse events and acute toxic effects were most common in the group given four cycles and 30 Gy.\n\nTwo cycles of ABVD with 20 Gy became the standard for this group, and the question then moved on: HD16 tested whether the radiotherapy could be dropped altogether when the interim positron emission tomography scan was negative, and found that it could not without losing tumour control.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT00265018","url":"https://clinicaltrials.gov/study/NCT00265018"},{"label":"New England Journal of Medicine 2010","url":"https://doi.org/10.1056/NEJMoa1000067"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["early-stage-classical-hodgkin-lymphoma","hodgkin-lymphoma"],"sections":["chemotherapy","radiation"],"technologies":["radiotherapy","cytotoxic-chemotherapy"],"targets":[],"drugs":["doxorubicin","bleomycin","vinblastine","dacarbazine"],"companies":["ghsg"],"institutions":[],"pathways":[],"terms":["abvd-beacopp"],"trials":["hd16","eortc-h10"],"people":["andreas-engert","peter-borchmann"],"bottlenecks":["b-toxicity-qol","b-survivorship"],"keyPapers":["paper-ghsg-hd10-reduced-intensity-early-hodgkin-nejm-2010"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00265018","phase":"3","setting":"Early-stage Hodgkin lymphoma with a favourable prognosis: four or two cycles of ABVD, each followed by 30 Gy or 20 Gy of involved-field radiotherapy, in a two by two design","sponsor":"University of Cologne (German Hodgkin Study Group)","result":"Two cycles of ABVD with 20 Gy as effective as four cycles with 30 Gy (five-year freedom from treatment failure 91.1 against 93.0 per cent, p = 0.39) and less toxic.","started":"1998-05","yearReported":2010,"enrolled":1370,"enrolledBasis":"registry","outcomes":[{"endpoint":"Freedom from treatment failure at 5 years","primary":true,"unit":"%","arms":[{"name":"Four cycles of ABVD","value":93,"note":"95 per cent confidence interval 90.5 to 94.8"},{"name":"Two cycles of ABVD","value":91.1,"note":"88.3 to 93.2"}],"p":"0.39","source":"https://doi.org/10.1056/NEJMoa1000067"}],"replication":"The radiation dose finding is consistent with the EORTC H9F experience; the chemotherapy finding set the comparator for HD16 and EORTC H10."},{"id":"hd16","kind":"trial","name":"GHSG HD16","aka":["HD16","Positron emission tomography-guided omission of radiotherapy in early Hodgkin lymphoma"],"tldr":"Trying to spare people radiotherapy by using a clear scan after two rounds of chemotherapy cost them about seven in a hundred in disease control, so the radiotherapy stayed.","summary":"Radiotherapy in early Hodgkin lymphoma is the main cause of the second cancers and heart disease that the Dutch late-effects cohorts measured decades later, so omitting it in people who respond quickly has been the field's most wanted de-escalation. HD16 tested it directly. 1,150 patients aged 18 to 75 with newly diagnosed early-stage favourable Hodgkin lymphoma were randomised to standard combined-modality treatment of two cycles of ABVD with 20 Gy of involved-field radiotherapy, or to a positron emission tomography-guided arm in which the radiotherapy was omitted after a negative scan.\n\nAmong the 628 patients with a negative scan treated per protocol, five-year progression-free survival was 93.4 per cent (95 per cent confidence interval 90.4 to 96.5) with combined-modality treatment and 86.1 per cent (81.4 to 90.9) with chemotherapy alone, a difference of 7.3 points (1.6 to 13.0) and a hazard ratio of 1.78 (1.02 to 3.12). Five-year overall survival was 98.1 and 98.4 per cent. Among the 693 patients assigned to combined-modality treatment, a positive scan after two cycles predicted worse progression-free survival, 88.4 against 93.2 per cent (p = 0.047), and the gap widened to 93.1 against 80.9 per cent (p = 0.0011) when the more common liver threshold of Deauville score 4 was used.\n\nThe trial is a clear negative for the de-escalation it tested and a clear positive for the prognostic value of the interim scan. It is also the reason that the current attempts to drop radiotherapy, such as RADAR, change the chemotherapy as well rather than relying on the scan alone.","status":"negative","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT00736320","url":"https://clinicaltrials.gov/study/NCT00736320"},{"label":"Journal of Clinical Oncology 2019","url":"https://doi.org/10.1200/JCO.19.00964"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["early-stage-classical-hodgkin-lymphoma","hodgkin-lymphoma"],"sections":["radiation","chemotherapy","imaging"],"technologies":["radiotherapy","pet-ct"],"targets":[],"drugs":["doxorubicin","bleomycin","vinblastine","dacarbazine"],"companies":["ghsg"],"institutions":[],"pathways":[],"terms":["deauville-score","abvd-beacopp"],"trials":["hd10","eortc-h10","radar-hodgkin"],"people":["peter-borchmann","andreas-engert"],"bottlenecks":["b-negative-results","b-survivorship","b-toxicity-qol"],"keyPapers":["paper-ghsg-hd16-pet-guided-early-favourable-hodgkin-jco-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00736320","phase":"3","setting":"Early-stage favourable Hodgkin lymphoma: two cycles of ABVD with 20 Gy involved-field radiotherapy against the same chemotherapy with radiotherapy omitted if the scan after two cycles is negative","sponsor":"University of Cologne (German Hodgkin Study Group)","result":"Omitting radiotherapy after a negative interim scan cost 7.3 percentage points of five-year progression-free survival (86.1 against 93.4 per cent), with identical overall survival.","started":"2009-11","yearReported":2019,"enrolled":1150,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 5 years, scan-negative patients","primary":true,"unit":"%","arms":[{"name":"Chemotherapy with radiotherapy","value":93.4,"note":"95 per cent confidence interval 90.4 to 96.5"},{"name":"Chemotherapy alone","value":86.1,"note":"81.4 to 90.9"}],"hr":1.78,"ci":[1.02,3.12],"source":"https://doi.org/10.1200/JCO.19.00964"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Chemotherapy with radiotherapy","value":98.1},{"name":"Chemotherapy alone","value":98.4}]}],"replication":"The same direction as the scan-negative comparison in EORTC H10 and the United Kingdom RAPID trial: omitting radiotherapy costs tumour control."},{"id":"hd18","kind":"trial","name":"GHSG HD18","aka":["HD18","Positron emission tomography-guided escalated BEACOPP"],"tldr":"People whose scan was clear after two rounds of the most intensive Hodgkin chemotherapy could stop after four rounds instead of six or eight, with the same disease control and far fewer severe infections.","summary":"Escalated BEACOPP controls advanced Hodgkin lymphoma better than ABVD and costs more in infections, organ damage, second leukaemias and infertility. HD18 asked whether the scan after two cycles could be used to give more to the people who need it and less to those who do not. 2,101 patients aged 18 to 60 were recruited at 301 sites in Germany, Switzerland, Austria, the Netherlands and the Czech Republic, and randomised by their scan result.\n\nIn the scan-positive cohort, adding rituximab to escalated BEACOPP changed nothing: five-year progression-free survival 89.7 per cent (95 per cent confidence interval 85.4 to 94.0) with escalated BEACOPP against 88.1 per cent (83.5 to 92.7) with rituximab added (log-rank p = 0.46). In the scan-negative cohort, four cycles were non-inferior to six or eight: 92.2 per cent (89.4 to 95.0) against 90.8 per cent (87.9 to 93.7), a difference of 1.4 points (minus 2.7 to 5.4). Four cycles caused fewer severe infections (8 against 15 per cent) and fewer organ toxicities (8 against 18 per cent).\n\nThe scan-positive result is worth stating as a failure: rituximab added nothing to an already intensive regimen and the field stopped pursuing it. The scan-negative result is why four cycles became the German standard, and why HD21 could then go further and replace the bleomycin, vincristine and procarbazine of escalated BEACOPP with brentuximab vedotin and dacarbazine.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT00515554","url":"https://clinicaltrials.gov/study/NCT00515554"},{"label":"Lancet 2017","url":"https://doi.org/10.1016/S0140-6736(17)32134-7"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["advanced-stage-classical-hodgkin-lymphoma","hodgkin-lymphoma"],"sections":["chemotherapy","imaging"],"technologies":["pet-ct","cytotoxic-chemotherapy"],"targets":[],"drugs":["bleomycin","etoposide","doxorubicin","cyclophosphamide","vincristine","procarbazine","prednisone","rituximab"],"companies":["ghsg"],"institutions":[],"pathways":[],"terms":["deauville-score","abvd-beacopp","non-inferiority"],"trials":["hd21","ahl2011"],"people":["peter-borchmann","andreas-engert"],"bottlenecks":["b-toxicity-qol","b-survivorship"],"keyPapers":["paper-ghsg-hd18-pet-guided-escalated-beacopp-lancet-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00515554","phase":"3","setting":"Aged 18 to 60 with newly diagnosed advanced-stage Hodgkin lymphoma: treatment intensity set by the scan after two cycles of escalated BEACOPP","sponsor":"University of Cologne (German Hodgkin Study Group)","result":"Four cycles of escalated BEACOPP non-inferior to six or eight after a negative scan (five-year progression-free survival 92.2 against 90.8 per cent) with half the severe infections; adding rituximab to a positive scan arm did nothing.","started":"2008-05","startedType":"actual","yearReported":2017,"enrolled":1945,"enrolledBasis":"randomised","enrolledNote":"The registry target was 1,500; 2,101 patients were recruited, 156 were found ineligible, and 1,945 were randomised across the two scan-defined cohorts in the Lancet report.","outcomes":[{"endpoint":"Progression-free survival at 5 years, scan-negative cohort","primary":true,"unit":"%","arms":[{"name":"Four cycles of escalated BEACOPP","n":501,"value":92.2,"note":"95 per cent confidence interval 89.4 to 95.0"},{"name":"Six or eight cycles of escalated BEACOPP","n":504,"value":90.8,"note":"87.9 to 93.7"}],"source":"https://doi.org/10.1016/S0140-6736(17)32134-7"},{"endpoint":"Progression-free survival at 5 years, scan-positive cohort","unit":"%","arms":[{"name":"Escalated BEACOPP","n":217,"value":89.7},{"name":"Escalated BEACOPP with rituximab","n":217,"value":88.1}],"p":"0.46"},{"endpoint":"Severe infections, scan-negative cohort","unit":"%","arms":[{"name":"Four cycles of escalated BEACOPP","n":498,"value":8},{"name":"Six or eight cycles of escalated BEACOPP","n":502,"value":15}]}],"replication":"The same de-escalation logic as AHL2011, which reached a similar conclusion by switching to ABVD instead of stopping early."},{"id":"hd21","kind":"trial","name":"GHSG HD21","aka":[],"tldr":"A new brentuximab-based intensive regimen matched Europe's most effective (and most toxic) chemotherapy with far fewer side effects.","summary":"GHSG HD21, trial NCT02661503 sponsored by the German Hodgkin Study Group and published in the Lancet in 2024, showed that a new brentuximab-based intensive regimen, BrECADD, matched and then beat escalated BEACOPP, Europe's most effective and most toxic chemotherapy for advanced Hodgkin lymphoma, with far fewer side effects. It randomised about 1,500 patients aged 18 to 60 to PET-guided BrECADD or escalated BEACOPP for four to six cycles, met non-inferiority and then superiority on progression-free survival at four and five years, and reduced treatment-related morbidity while preserving fertility markers. OnCo links it to Hodgkin lymphoma, PET-adapted therapy, brentuximab vedotin, Peter Borchmann, the German Hodgkin Study Group and the ECHELON-1 and S1826 papers. Whether an intensive regimen is still needed when nivolumab-AVD has performed so well is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02661503","url":"https://clinicaltrials.gov/study/NCT02661503"}],"tags":[],"related":["lymphoma-roadmap","hd18","ahl2011","hd10"],"cancers":["hodgkin-lymphoma","advanced-stage-classical-hodgkin-lymphoma"],"sections":[],"technologies":["pet-adapted-therapy"],"targets":[],"drugs":["brentuximab-vedotin","doxorubicin"],"companies":["gbg","ghsg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["peter-borchmann"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02661503","phase":"3","setting":"Untreated advanced-stage classical Hodgkin lymphoma, age 18-60: PET-guided BrECADD vs escalated BEACOPP","sponsor":"German Hodgkin Study Group","result":"4-year PFS 94.3% vs 90.9%, HR 0.66; less toxicity.","started":"2016-07","yearReported":2024,"enrolled":1500,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 4 years","primary":true,"unit":"%","arms":[{"name":"BrECADD","n":742,"value":94.3},{"name":"eBEACOPP","n":740,"value":90.9}],"hr":0.66,"ci":[0.45,0.97],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01315-1/fulltext"},{"endpoint":"Treatment-related morbidity","unit":"%","arms":[{"name":"BrECADD","value":42},{"name":"eBEACOPP","value":59}],"source":"https://doi.org/10.1016/S0140-6736(24)01315-1"}]},{"id":"nct04977453","kind":"trial","name":"GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors","aka":["Keynote B59"],"tldr":"A phase 1/2 trial of Pembrolizumab, Lenvatinib in cervical cancer and non-small-cell lung cancer, run by GI Innovation, Inc., now recruiting.","summary":"GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT04977453 by GI Innovation, Inc., with 317 participants planned, started 2021-08-02 and due to reach its primary completion in 2028-06-30. Interventions recorded: GI-101, Pembrolizumab (KEYTRUDA®), Lenvatinib, GI-101A. Conditions listed: Advanced Solid Tumor, Metastatic Solid Tumor, Cervical Cancer, Urothelial Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04977453","url":"https://clinicaltrials.gov/study/NCT04977453"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","nsclc","sclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["pembrolizumab","lenvatinib"],"companies":["gi-innovation"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04977453","phase":"1/2","setting":"A Phase 1/2, Open-label, Dose-escalation, Dose-optimization and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101/GI-101A as a Single Agent and in Combination With Pembrolizumab or Lenvatinib in Patients With Advanced or Metastatic Solid Tumors (Keynote B59)","sponsor":"GI Innovation, Inc.","started":"2021-08-02","startedType":"actual","enrolled":317,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07432295","kind":"trial","name":"Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)","aka":["GIVA-2"],"tldr":"A phase 2 trial of Nivolumab, FLOT, CAPOX in metastatic cancer, run by I-Mab Biopharma US Limited, now recruiting.","summary":"Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2) is a phase 2 interventional study registered as NCT07432295 by I-Mab Biopharma US Limited, with 180 participants planned, started 2026-02-11 and due to reach its primary completion in 2030-03. Interventions recorded: Givastomig, Nivolumab, 5Fluorouracil, Leucovorin, Oxaliplatin. Conditions listed: Solid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07432295","url":"https://clinicaltrials.gov/study/NCT07432295"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","flot","capox","capecitabine"],"companies":["i-mab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07432295","phase":"2","setting":"A Randomized, Multicenter, Open-Label, Phase 2 Study of Givastomig (TJ033721) in Combination With Nivolumab and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated CLDN18.2 Positive and PD-1L Positive Locally Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma","sponsor":"I-Mab Biopharma US Limited","started":"2026-02-11","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07209813","kind":"trial","name":"GKL-006 Injection Plus TACE Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma","aka":[],"tldr":"A phase 2 trial of GKL-006 Injection in hepatocellular carcinoma, run by Beijing Gene Key Life Technology Co., Ltd, now recruiting.","summary":"GKL-006 Injection Plus TACE Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma is a phase 2 interventional study registered as NCT07209813 by Beijing Gene Key Life Technology Co., Ltd, with 48 participants planned, started 2025-11-14 and due to reach its primary completion in 2027-09-30. Interventions recorded: GKL-006 Injection and TACE.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07209813","url":"https://clinicaltrials.gov/study/NCT07209813"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-intermediate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["beijing-gene-key-life-technology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07209813","phase":"2","setting":"A Multicenter, Randomized, Open-Label, Controlled Phase 2 Study of GKL-006 Injection in Combination With Transarterial Chemoembolization (TACE) Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma","sponsor":"Beijing Gene Key Life Technology Co., Ltd","started":"2025-11-14","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05804370","kind":"trial","name":"Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)","aka":[],"tldr":"A phase 3 trial of 5-Aminolevulinic acid in ovarian cancer, run by NX Development Corp, now recruiting.","summary":"Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302) is a phase 3 interventional study registered as NCT05804370 by NX Development Corp, with 170 participants planned, started 2024-05-30 and due to reach its primary completion in 2028-09. Interventions recorded: Gleolan. Conditions listed: Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05804370","url":"https://clinicaltrials.gov/study/NCT05804370"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["fluorescence-guided-surgery","optical-imaging"],"targets":[],"drugs":["aminolevulinic-acid-gleolan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05804370","phase":"3","setting":"A Phase 3 Multicenter Study of Gleolan® (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Suspected Newly Diagnosed or Recurrent Epithelial Ovarian Cancer","sponsor":"NX Development Corp","started":"2024-05-30","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04121455","kind":"trial","name":"Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients","aka":["GLORIA"],"tldr":"A phase 1/2 trial of Bevacizumab, Pembrolizumab and Temozolomide in glioma & glioblastoma, run by TME Pharma AG, active and no longer recruiting.","summary":"Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients is a phase 1/2 interventional study registered as NCT04121455 by TME Pharma AG, with 117 participants enrolled, started 2019-09-12 and due to reach its primary completion in 2028-12. Interventions recorded: Olaptesed pegol, Radiotherapy, Bevacizumab, Pembrolizumab and Temozolomide (TMZ).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04121455","url":"https://clinicaltrials.gov/study/NCT04121455"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab","pembrolizumab","temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04121455","phase":"1/2","setting":"Single-arm, Dose-escalation Phase 1/2 Study of Olaptesed Pegol (NOX-A12) in Combination With Irradiation in Inoperable or Partially Resected First-line Glioblastoma Patients With Unmethylated MGMT Promoter With a Multiple-arm Expansion Group","sponsor":"TME Pharma AG","started":"2019-09-12","startedType":"actual","enrolled":117,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07718737","kind":"trial","name":"Global, Multicenter Study of AMT-116 Versus Investigator's Choice in Participants With Advanced or Metastatic Non-squamous EGFR-Wildtype Non-Small Cell Lung Can","aka":[],"tldr":"A phase 2/3 trial of AMT-116 and ramucirumab in lung cancer, run by Multitude Therapeutics Inc., not yet recruiting.","summary":"Global, Multicenter Study of AMT-116 Versus Investigator's Choice in Participants With Advanced or Metastatic Non-squamous EGFR-Wildtype Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy is a phase 2/3, randomised interventional study registered as NCT07718737 by Multitude Therapeutics Inc., with a registry enrolment figure of 512 participants, started 2026-08-28 and due to reach its primary completion in 2028-03-30. Interventions recorded: AMT-116; Investigator's choice regimens (docetaxel or docetaxel plus ramucirumab). Conditions listed: NSCLC (Advanced Non-small Cell Lung Cancer). Primary outcome: Number of Participants with Adverse Events as Assessed by CTCAE v6.0. Lung eligibility wording from the registry: \"Diagnosed with non-squamous non-small cell lung cancer (NSCLC) confirmed by pathological or cytological tests\". Sites: Australia, United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07718737","url":"https://clinicaltrials.gov/study/NCT07718737"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["amt-116","ramucirumab"],"companies":["multitude-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07718737","phase":"2/3","setting":"Open-Label, Global, Multicenter, Randomized, Phase 2/3 Study of AMT-116 Versus Investigator's Choice in Participants With Advanced or Metastatic Non-squamous EGFR-Wildtype Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy","sponsor":"Multitude Therapeutics Inc.","started":"2026-08-28","startedType":"estimated","enrolled":512,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06252675","kind":"trial","name":"Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma","aka":[],"tldr":"A phase 2 trial of Obinutuzumab, Glofitamab, Pirtobrutinib and clonoSEQ in Mantle cell lymphoma, run by University of California, San Francisco, now recruiting.","summary":"Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma is a phase 2 interventional study registered as NCT06252675 by University of California, San Francisco, with 30 participants planned, started 2024-06-11 and due to reach its primary completion in 2028-07-31. Interventions recorded: Obinutuzumab, Glofitamab, Pirtobrutinib, Tumor Imaging, Biospecimen Collection, ClonoSeq Assay, Bone Marrow Biopsy. Conditions recorded: Mantle Cell Lymphoma.\n\nLinked to the drug clonoSEQ because the registry names it among its interventions and Mantle cell lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06252675","url":"https://clinicaltrials.gov/study/NCT06252675"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["obinutuzumab","glofitamab","pirtobrutinib","clonoseq"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06252675","phase":"2","setting":"A Multicenter Phase 2 Study of Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma","sponsor":"University of California, San Francisco","started":"2024-06-11","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"glow","kind":"trial","name":"GLOW","aka":[],"tldr":"Fifteen months of two oral drugs cut the risk of progression by nearly 80% versus chemoimmunotherapy in older patients, and later showed a survival advantage.","summary":"GLOW, trial NCT03462719 sponsored by Janssen and published in NEJM Evidence in 2022, showed that fifteen months of ibrutinib and venetoclax cut the risk of progression by nearly eighty percent versus chlorambucil plus obinutuzumab in older or comorbid patients with previously untreated chronic lymphocytic leukaemia without del(17p), and later showed a survival advantage. It randomised 211 patients, met its primary progression-free survival endpoint with far higher rates of undetectable MRD in marrow, and the four-year update showed improved overall survival; the European Union approved the regimen in 2022 but it is not FDA-approved. OnCo links it to chronic lymphocytic leukaemia, BTK and BCL-2 as targets, ibrutinib, venetoclax, obinutuzumab and the fixed-duration pairing, and CAPTIVATE, AMPLIFY and FLAIR support the approach. Whether the regimen reaches US patients is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03462719","url":"https://clinicaltrials.gov/study/NCT03462719"}],"tags":[],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["btk","bcl2"],"drugs":["ibrutinib","venetoclax","obinutuzumab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03462719","phase":"3","setting":"Previously untreated CLL, age ≥65 or with comorbidities, no del(17p)/TP53: fixed-duration ibrutinib + venetoclax vs chlorambucil + obinutuzumab","sponsor":"Janssen","result":"PFS HR 0.216; OS HR 0.487 (4-year).","started":"2018-04-17","startedType":"actual","yearReported":2021,"enrolled":211,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"arms":[{"name":"Ibrutinib + venetoclax","n":106},{"name":"Chlorambucil + obinutuzumab","n":105}],"hr":0.216,"ci":[0.131,0.357],"p":"<0.0001","source":"https://evidence.nejm.org/doi/full/10.1056/EVIDoa2200006"},{"endpoint":"Undetectable MRD in bone marrow at 3 months post-treatment","unit":"%","arms":[{"name":"Ibrutinib + venetoclax","value":51.9},{"name":"Chlorambucil + obinutuzumab","value":17.1}],"source":"https://doi.org/10.1056/EVIDoa2200006"}],"replication":"CAPTIVATE (single-arm, younger) and AMPLIFY (acalabrutinib-venetoclax) support BTKi + BCL2i fixed duration; FLAIR (UK, ibrutinib-venetoclax vs FCR) also positive."},{"id":"nct01305655","kind":"trial","name":"Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL","aka":["NOPHOCPG2"],"tldr":"A phase 3 trial of Glucarpidase in Acute lymphoblastic leukaemia, run by Nordic Society for Pediatric Hematology and Oncology, completed.","summary":"Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL is a phase 3 interventional study registered as NCT01305655 by Nordic Society for Pediatric Hematology and Oncology, with 47 participants recorded, started 2008-07 and reaching its primary completion in 2014-12. Interventions recorded: Glucarpidase. Conditions recorded: Acute Lymphoblastic Leukemia (ALL).\n\nLinked to the drug Glucarpidase because the registry names it among its interventions and Acute lymphoblastic leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01305655","url":"https://clinicaltrials.gov/study/NCT01305655"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":[],"targets":[],"drugs":["glucarpidase"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01305655","phase":"3","setting":"Glucarpidase (CPG2) Effect on Severe Delayed Methotrexate-clearance in Children Treated With High-dose Methotrexate in Acute Lymphoblastic Leukemia (ALL)","sponsor":"Nordic Society for Pediatric Hematology and Oncology","started":"2008-07","yearReported":2017,"enrolled":47,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Adverse Event to HD-MTX Treatment in NOPHO ALL-2008 as a Measure of Toxic Mtx Concentrations in Blood, Nephrotoxicity, Hepatotoxicity, Mucositis, MTX Elimination Time and Permanent Kidney Damage.","primary":true,"unit":"participants","arms":[{"name":"Glucarpidase Arm","n":47,"value":47,"note":"Figures from the ClinicalTrials.gov results section (first posted 2017-02-03), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01305655?tab=results"}]},{"id":"nct01954992","kind":"trial","name":"Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial of Glufosfamide in pancreatic ductal adenocarcinoma, run by Eleison Pharmaceuticals LLC., now recruiting.","summary":"Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer is a phase 3 interventional study registered as NCT01954992 by Eleison Pharmaceuticals LLC., with 480 participants planned, started 2014-04 and due to reach its primary completion in 2026-06. Interventions recorded: Glufosfamide and Fluorouracil.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01954992","url":"https://clinicaltrials.gov/study/NCT01954992"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01954992","phase":"3","setting":"A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Fluorouracil (5-FU) in Patients With Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine","sponsor":"Eleison Pharmaceuticals LLC.","started":"2014-04","enrolled":480,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06980532","kind":"trial","name":"Glumetinib Combined With Fruquintinib in the Treatment of MET Amplification or Protein Overexpression in Third-Line Unresectable Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of fruquintinib in colorectal cancer, run by Liu Huang, now recruiting.","summary":"Glumetinib Combined With Fruquintinib in the Treatment of MET Amplification or Protein Overexpression in Third-Line Unresectable Metastatic Colorectal Cancer is a phase 1/2, interventional study registered as NCT06980532 by Liu Huang, with a registry enrolment figure of 42 participants, started 2025-04-25 and due to reach its primary completion in 2028-12-30. Interventions recorded: Glumetinib Combined with Fruquintinib. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Recommended dose for Phase II; Objective response rate(ORR). Colorectal eligibility wording from the registry: \"Patients with unresectable metastatic colorectal cancer with microsatellite stable (MSS) confirmed by pathology or histology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06980532","url":"https://clinicaltrials.gov/study/NCT06980532"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06980532","phase":"1/2","setting":"Glumetinib Combined With Fruquintinib in the Treatment of MET Amplification or Protein Overexpression in Third-Line Unresectable Metastatic Colorectal Cancer: A Prospective, Exploratory, Open-Label Clinical Study","sponsor":"Liu Huang","started":"2025-04-25","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06908772","kind":"trial","name":"Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients","aka":[],"tldr":"A phase 2/3 trial in lung cancer, run by Shanghai JMT-Bio Inc., not yet recruiting.","summary":"Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients is a phase 2/3, randomised interventional study registered as NCT06908772 by Shanghai JMT-Bio Inc., with a registry enrolment figure of 390 participants, started 2025-04-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: Glumetinib Tablets; Osimertinib Mesylate Tablets; Glumetinib Tablets Placebo. Conditions listed: Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression. Primary outcome: Phase 2：ORR as assessed by IRC. Lung eligibility wording from the registry: \"Patients with NSCLC who have unresectable locally advanced or metastatic disease; 4\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06908772","url":"https://clinicaltrials.gov/study/NCT06908772"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","met-altered-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06908772","phase":"2/3","setting":"A Multicenter Phase II/III Clinical Study on the Efficacy and Safety of Glumetinib Combined With Osimertinib as First-Line Treatment in Non-Small Cell Lung Cancer Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression","sponsor":"Shanghai JMT-Bio Inc.","started":"2025-04-01","startedType":"estimated","enrolled":390,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05852990","kind":"trial","name":"Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Instituto Nacional de Cancerologia de Mexico, now recruiting.","summary":"Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC is a phase 3, randomised interventional study registered as NCT05852990 by Instituto Nacional de Cancerologia de Mexico, with a registry enrolment figure of 28 participants, started 2022-03-01 and due to reach its primary completion in 2026-12-01. Interventions recorded: Glutamine plus L. reuteri. Conditions listed: Non-Small Cell Lung Cancer With EGFR Mutation. Primary outcome: Diarrhea toxicity; Functional Assessment of Chronic Illness Therapy. Lung eligibility wording from the registry: \"* Pathologically confirmed diagnosis of NSCLC\". Sites: Mexico. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05852990","url":"https://clinicaltrials.gov/study/NCT05852990"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05852990","phase":"3","setting":"Effect of Glutamine Plus Lactobacillus Reuteri Added to an Astringent Diet in Preventing Diarrhea Caused by Tyrosine Kinase Inhibitors (TKIs) in Patients With Advanced Non-small Cell Lung Cancer","sponsor":"Instituto Nacional de Cancerologia de Mexico","started":"2022-03-01","startedType":"actual","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06994507","kind":"trial","name":"GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer","aka":[],"tldr":"A phase 3 trial of GM1 in advanced solid tumours, run by Qilu Pharmaceutical Co., Ltd., now recruiting.","summary":"GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer is a phase 3 interventional study registered as NCT06994507 by Qilu Pharmaceutical Co., Ltd., with 352 participants planned, started 2025-08-01 and due to reach its primary completion in 2026-09. Interventions recorded: GM1 and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06994507","url":"https://clinicaltrials.gov/study/NCT06994507"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06994507","phase":"3","setting":"A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial of GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer（Gypsophila )","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2025-08-01","startedType":"actual","enrolled":352,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06265025","kind":"trial","name":"GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in melanoma and colorectal cancer, run by GeneMedicine Co., Ltd., now recruiting.","summary":"GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06265025 by GeneMedicine Co., Ltd., with 125 participants planned, started 2024-02-20 and due to reach its primary completion in 2025-05-30. Interventions recorded: GM103 (Part A), GM103 (Part B), GM103 and Pembrolizumab (Part C). Conditions listed: Head and Neck Cancer, Malignant Melanoma, Colorectal Cancer, Renal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06265025","url":"https://clinicaltrials.gov/study/NCT06265025"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","colorectal","rcc","cervical"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06265025","phase":"1/2","setting":"A Phase I/II, Open-label, Dose-escalation With Expansion Study of GM103 Via Intratumoral Injection, Alone and in Combination With Pembrolizumab in Adult Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors","sponsor":"GeneMedicine Co., Ltd.","started":"2024-02-20","startedType":"actual","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07802184","kind":"trial","name":"GnP Combined With SHR-1701 and Apatinib as First-Line Treatment for Locally Advanced or Metastatic PDAC","aka":[],"tldr":"A phase 1/2 trial of retlirafusp alfa, rivoceranib (apatinib), gemcitabine and nab-paclitaxel in pancreatic cancer, run by West China Hospital, not yet recruiting.","summary":"GnP Combined With SHR-1701 and Apatinib as First-Line Treatment for Locally Advanced or Metastatic PDAC is a phase 1/2, interventional study registered as NCT07802184 by West China Hospital, with a registry enrolment figure of 45 participants, started 2026-09-10 and due to reach its primary completion in 2029-01-01. Interventions recorded: SHR-1701; Apatinib; gemcitabine; Nab-paclitaxel. Conditions listed: Locally Advanced Pancreatic Cancer; Metastatic Pancreatic Cancer. Primary outcome: Recommended Phase II Dose (RP2D); Objective Response Rate (ORR). Pancreatic eligibility wording from the registry: \"1\\) Age 18-75 years, regardless of sex; 2) patients with histologically confirmed pancreatic ductal adenocarcinoma (PDAC); 3) previously untreated patients with unresectable locally advanced or metastatic PDAC, with at least one measurable lesion according to RECIST v1\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07802184","url":"https://clinicaltrials.gov/study/NCT07802184"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["retlirafusp-alfa","rivoceranib","gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07802184","phase":"1/2","setting":"GnP Combined With SHR-1701 and Apatinib as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma: A Single-Center, Open-Label, Phase Ib/II Trial","sponsor":"West China Hospital","started":"2026-09-10","startedType":"estimated","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"gog-0218-icon7","kind":"trial","name":"GOG-0218 & ICON7 (bevacizumab)","aka":[],"tldr":"Adding the blood-vessel blocker bevacizumab to first-line chemotherapy delayed relapse by a few months but did not extend life overall.","summary":"GOG-0218 (1,873 patients): PFS 14.1 vs 10.3 months with concurrent-plus-maintenance bevacizumab (HR 0.72); no OS benefit (NEJM 2011). ICON7 (1,528): modest PFS gain, with an OS benefit confined to high-risk (stage IV or suboptimally debulked) disease. Bevacizumab became a first-line option, mainly for high-risk patients and as the partner for olaparib in PAOLA-1.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00262847","url":"https://clinicaltrials.gov/study/NCT00262847"},{"label":"GOG-0218, NEJM 2011","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1104390"}],"tags":[],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":["vegf"],"drugs":["bevacizumab","carboplatin","paclitaxel"],"companies":["mrc-ctu","arcagy-gineco","gog-foundation"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jonathan-ledermann"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00262847","phase":"3","setting":"Newly diagnosed advanced ovarian cancer: carboplatin-paclitaxel ± bevacizumab with bevacizumab maintenance","sponsor":"GOG; MRC/ICON","result":"GOG-0218 PFS 14.1 vs 10.3 months (HR 0.72); no OS benefit.","started":"2005-09","yearReported":2011,"enrolled":3401,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (GOG-0218)","primary":true,"unit":"months","arms":[{"name":"Bevacizumab throughout","value":14.1},{"name":"Chemotherapy alone","value":10.3}],"hr":0.72,"ci":[0.63,0.82],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1104390"}]},{"id":"nct06198907","kind":"trial","name":"Golidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC)","aka":["JACKPOT33"],"tldr":"A phase 2 trial of golidocitinib and sintilimab in lung cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, not yet recruiting.","summary":"Golidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC) is a phase 2, interventional study registered as NCT06198907 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 69 participants, started 2024-01 and due to reach its primary completion in 2026-12. Interventions recorded: Golidocitinib; Sintilimab; platinum doublet chemotherapy. Conditions listed: Non-Small-Cell Lung Cancer. Primary outcome: Overall response rate (ORR) (cohort1); Progression-free survival (PFS) (cohort2). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) , Stage IIIB/IIIC (not suitable for concomitant chemoradiotherapy) or Stage IV according to AJCC 8th\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06198907","url":"https://clinicaltrials.gov/study/NCT06198907"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["golidocitinib","sintilimab"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06198907","phase":"2","setting":"A Phase 2, Open-label, Single Arm Study to Investigate the Safety and Efficiency of Golidocitinib in Combination With Sintilimab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With PD-L1TPS ≥ 1%)","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2024-01","startedType":"estimated","enrolled":69,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07110103","kind":"trial","name":"Golidocitinib With PD-1 Inhibitors as Maintenance Treatment for Previously Untreated ES-SCLC","aka":["JACKPOT38"],"tldr":"A phase 2 trial of golidocitinib in lung cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"Golidocitinib With PD-1 Inhibitors as Maintenance Treatment for Previously Untreated ES-SCLC is a phase 2, interventional study registered as NCT07110103 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 20 participants, started 2025-10-31 and due to reach its primary completion in 2027-03-31. Interventions recorded: golidocitinib with PD-1 inhibitors. Conditions listed: SCLC; SCLC, Extensive Stage. Primary outcome: Progression-Free Survival (PFS). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed ES-SCLC (stage IV \\[any T stage, any N stage, M1 a/b/c stage\\] according to the 8th edition of the AJCC TNM staging system for lung cancer, or T3-4 stage disease caused by multiple lung nodules and the disease is too diffuse, or the tumor/nodule volume is to\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07110103","url":"https://clinicaltrials.gov/study/NCT07110103"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["golidocitinib"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07110103","phase":"2","setting":"Golidocitinib With PD-1 Inhibitors as Maintenance Treatment in Patients With Previously Untreated Extensive-stage Small Cell Lung Cancer: an Open-label, Single-arm, Phase 2 Study","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2025-10-31","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"golseek-1","kind":"trial","name":"GOLSEEK-1","aka":[],"tldr":"GOLSEEK-1 is a recruiting phase 3 that tests whether adding golcadomide, an oral cereblon-modulating degrader, to R-CHOP raises cure rates in untreated high-risk large B-cell lymphoma. It builds on high complete response rates in phase 1b, and readout is expected in 2027 to 2028.","summary":"GOLSEEK-1, trial NCT06356129 sponsored by Bristol Myers Squibb, tests whether adding golcadomide, a potent oral cereblon-modulating degrader, to R-CHOP raises cure rates in untreated high-risk large B-cell lymphoma with IPI 3 to 5. It builds on phase 1b data with high complete response rates, and readout is expected in 2027 to 2028. OnCo links it to lymphoma and golcadomide. It is recruiting with no results, and whether an oral degrader can do in the frontline what lenalidomide failed to do in earlier trials is the question it will answer.","status":"active","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06356129","url":"https://clinicaltrials.gov/study/NCT06356129"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["protac-degrader"],"targets":[],"drugs":["golcadomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06356129","phase":"3","setting":"Untreated high-risk LBCL (IPI 3-5): golcadomide + R-CHOP vs placebo + R-CHOP","sponsor":"BMS","started":"2024-06-19","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"nct07337551","kind":"trial","name":"Gossypol Acetate + FOLFIRI + Bev in mCRC With TP53-Mutant and LRPPRC Positive","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Guiying Wang, not yet recruiting.","summary":"Gossypol Acetate + FOLFIRI + Bev in mCRC With TP53-Mutant and LRPPRC Positive is a phase 2, interventional study registered as NCT07337551 by Guiying Wang, with a registry enrolment figure of 20 participants, started 2026-02-01 and due to reach its primary completion in 2028-02-01. Interventions recorded: Gossypol acetate Combined with Bevacizumab and FOLFIRI. Conditions listed: Patients With Metastatic Colorectal Cancer Who Were TP53-mutant and LRPPRC-positive and Had Previously Failed Prior First-line Treatment. Primary outcome: Primary Endpoint. Colorectal eligibility wording from the registry: \"Histopathologically or cytologically confirmed adenocarcinoma of the colon or rectum\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07337551","url":"https://clinicaltrials.gov/study/NCT07337551"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07337551","phase":"2","setting":"Gossypol Acetate Combined With Bevacizumab and FOLFIRI as Second-Line Therapy for Metastatic Colorectal Cancer With TP53 Mutation and LRPPRC Positivity: A Single-Center, Single-Arm Clinical Study","sponsor":"Guiying Wang","started":"2026-02-01","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"goteborg-2","kind":"trial","name":"GÖTEBORG-2 (MRI-based prostate cancer screening)","aka":[],"tldr":"In GÖTEBORG-2, 17,980 men were screened with PSA, then MRI; biopsying only what the MRI showed halved the detection of harmless prostate cancers (0.6% versus 1.2% of men) while the detection of dangerous cancers barely changed (0.9% versus 1.1%). It is the strongest evidence that MRI-first screening cuts overdiagnosis.","summary":"17,980 men were invited; those with PSA of 3 ng/mL or more had MRI. In the experimental group (targeted biopsy of MRI-visible lesions only) clinically insignificant cancer was detected in 0.6% of men versus 1.2% in the reference group (systematic plus targeted biopsy), a relative risk of 0.46, while clinically significant cancer was found in 0.9% versus 1.1% (NEJM 2022). Follow-up rounds have shown that the deferred diagnoses rarely progress to advanced disease. The trial is the strongest evidence that MRI-first screening can retain the mortality benefit of PSA while cutting overdiagnosis.","status":"positive","asOf":"2026-09-10","links":[{"label":"GÖTEBORG-2 (NEJM 2022)","url":"https://doi.org/10.1056/NEJMoa2209454"}],"tags":[],"related":[],"cancers":["prostate"],"sections":[],"technologies":["prostate-screening-psa-mri","mp-mri"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["psa","overdiagnosis"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-goteborg-2-n-engl-j-med-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN94604465","phase":"3","setting":"Population-based screening of men aged 50 to 60 in Gothenburg: PSA then MRI, with MRI-targeted biopsy only versus systematic plus targeted biopsy","sponsor":"University of Gothenburg","result":"Clinically insignificant cancer 0.6% vs 1.2% (RR 0.46); clinically significant cancer 0.9% vs 1.1%.","yearReported":2022,"enrolled":17980,"enrolledBasis":"registry","outcomes":[{"endpoint":"Detection of clinically insignificant prostate cancer","primary":true,"unit":"%","arms":[{"name":"MRI-targeted biopsy only","value":0.6},{"name":"Systematic plus targeted biopsy","value":1.2}],"hr":0.46,"source":"https://doi.org/10.1056/NEJMoa2209454"}]},{"id":"goya","kind":"trial","name":"GOYA","aka":["Obinutuzumab versus rituximab in first-line diffuse large B-cell lymphoma","GOYA trial"],"tldr":"A newer antibody against the same target as rituximab was tested in first-line treatment for the commonest aggressive lymphoma and did not work better, while causing more side effects.","summary":"Obinutuzumab is a glycoengineered type II anti-CD20 antibody that had already beaten rituximab on progression-free survival in chronic lymphocytic leukaemia and in follicular lymphoma (GALLIUM). GOYA tested the same substitution in untreated advanced diffuse large B-cell lymphoma, randomising 1,418 patients to eight 21-day cycles of obinutuzumab (706) or rituximab (712) with six or eight cycles of CHOP.\n\nAfter a median observation of 29 months the investigator-assessed progression-free survival events were almost identical, 201 (28.5 per cent) with obinutuzumab and 215 (30.2 per cent) with rituximab, a stratified hazard ratio of 0.92 (95 per cent confidence interval 0.76 to 1.11, p = 0.39), with three-year rates of 70 and 67 per cent. Independently reviewed progression-free survival, the other time-to-event endpoints and response rates were all similar. Grade 3 to 5 adverse events were more frequent with obinutuzumab (73.7 against 64.7 per cent), as were serious adverse events (42.6 against 37.6 per cent) and fatal events (5.8 against 4.3 per cent).\n\nGOYA matters because it broke the assumption that an antibody improvement carries across B-cell lymphomas. The exploratory finding that germinal-centre B-cell tumours did better than activated B-cell tumours irrespective of treatment is the clearest signal the trial left behind, and it points at the genetic subtype work rather than at the antibody. The registry lists the study as terminated, which reflects the end of a programme that did not continue rather than a safety stop.","status":"negative","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT01287741","url":"https://clinicaltrials.gov/study/NCT01287741"},{"label":"Journal of Clinical Oncology 2017","url":"https://doi.org/10.1200/JCO.2017.73.3402"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["dlbcl","non-hodgkin-lymphoma"],"sections":["immunotherapy","chemotherapy"],"technologies":["monoclonal-antibody"],"targets":["cd20"],"drugs":["obinutuzumab","rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["r-chop","cell-of-origin"],"trials":["gallium"],"people":["laurie-sehn"],"bottlenecks":["b-negative-results","b-biomarker-validation"],"keyPapers":["paper-goya-obinutuzumab-vs-rituximab-chop-dlbcl-jco-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01287741","phase":"3","setting":"Untreated advanced diffuse large B-cell lymphoma: obinutuzumab with CHOP against rituximab with CHOP","sponsor":"Hoffmann-La Roche","result":"Progression-free survival hazard ratio 0.92 (p = 0.39): no benefit over rituximab, with more grade 3 to 5 and fatal adverse events.","started":"2011-07-26","startedType":"actual","yearReported":2017,"enrolled":1418,"enrolledBasis":"registry","outcomes":[{"endpoint":"Investigator-assessed progression-free survival","primary":true,"arms":[{"name":"Obinutuzumab with CHOP","n":706,"note":"three-year rate 70 per cent"},{"name":"Rituximab with CHOP","n":712,"note":"three-year rate 67 per cent"}],"hr":0.92,"ci":[0.76,1.11],"p":"0.39","source":"https://doi.org/10.1200/JCO.2017.73.3402"}],"replication":"The opposite result to GALLIUM in follicular lymphoma, which is the point: the two diseases did not behave alike."},{"id":"nct04864054","kind":"trial","name":"GPC3-Targeted T-Cell Therapy (ECT204) in Adults With Advanced HCC","aka":["ARYA-3"],"tldr":"A phase 1/2 trial of ECT204 T cells in hepatocellular carcinoma, run by Eureka Therapeutics Inc., now recruiting.","summary":"GPC3-Targeted T-Cell Therapy (ECT204) in Adults With Advanced HCC is a phase 1/2 interventional study registered as NCT04864054 by Eureka Therapeutics Inc., with 60 participants planned, started 2022-03-11 and due to reach its primary completion in 2027-12-31. Interventions recorded: ECT204 T cells.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04864054","url":"https://clinicaltrials.gov/study/NCT04864054"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["eureka-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04864054","phase":"1/2","setting":"An Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of ECT204 T-Cell Therapy in Adults With Advanced Hepatocellular Carcinoma (HCC)","sponsor":"Eureka Therapeutics Inc.","started":"2022-03-11","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06566547","kind":"trial","name":"GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma","aka":[],"tldr":"A phase 2 trial of GR1803 in multiple myeloma, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd., active and no longer recruiting.","summary":"GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT06566547 by Genrix (Shanghai) Biopharmaceutical Co., Ltd., with 116 participants planned, started 2024-08-26 and due to reach its primary completion in 2027-05-12. Interventions recorded: GR1803 injection. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06566547","url":"https://clinicaltrials.gov/study/NCT06566547"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["gr1803"],"companies":["genrix-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06566547","phase":"2","setting":"Single-Arm, Open, Multi-Center Phase II Clinical Trial of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma","sponsor":"Genrix (Shanghai) Biopharmaceutical Co., Ltd.","started":"2024-08-26","startedType":"actual","enrolled":116,"enrolledBasis":"registry","outcomes":[]},{"id":"graall-2005","kind":"trial","name":"GRAALL-2005","aka":["GRAALL 2005","GRAALL"],"tldr":"GRAALL-2005 treated adults with acute lymphoblastic leukaemia using an intensive protocol borrowed from children's medicine and asked whether giving cyclophosphamide in a more intense split schedule helped; it did not, and the trial also showed that people aged 55 and over tolerate the paediatric-style treatment poorly.","summary":"GRAALL-2005 was the French, Belgian and Swiss GRAALL group's randomised phase 3 protocol for adults aged 18 to 59 with newly diagnosed acute lymphoblastic leukaemia. Patients were assigned by immunophenotype and genetics to three linked trials (T-cell or Philadelphia-negative B-cell disease, CD20-positive B-cell disease with or without rituximab, and Philadelphia-positive disease under GRAAPH-2005). The paediatric-inspired backbone came from the earlier GRAALL-2003 study. The randomised question reported in 2018 was whether hyperfractionated cyclophosphamide in first induction and late intensification improved outcomes.\n\nAmong 787 evaluable patients the complete remission rate was 91.9 percent, five-year event-free survival 52.2 percent and overall survival 58.5 percent. Hyperfractionated cyclophosphamide did not raise the remission rate or lengthen event-free or overall survival, except in the minority aged 55 and over, who otherwise tolerated the whole programme poorly. The protocol is one of the reference paediatric-inspired regimens for younger adults, alongside CALGB 10403 and UKALL.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00327678","url":"https://clinicaltrials.gov/study/NCT00327678"}],"tags":["soc-trials"],"related":[],"cancers":["all-leukemia","leukaemia"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-graall-2005-huguet-jco-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00327678","phase":"3","setting":"Adults aged 18 to 59 with newly diagnosed Philadelphia-negative acute lymphoblastic leukaemia treated with a paediatric-inspired protocol: standard-dose or hyperfractionated cyclophosphamide during induction and late intensification","sponsor":"Assistance Publique - Hôpitaux de Paris","result":"Hyperfractionated cyclophosphamide did not improve remission, event-free or overall survival; five-year event-free survival was 52.2 percent overall and 55.7 percent under age 55 against 25.8 percent at 55 and over.","started":"2006-05","yearReported":2018,"enrolled":1080,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete remission","unit":"%","arms":[{"name":"All evaluable patients on the paediatric-inspired protocol","n":787,"value":91.9}],"source":"https://doi.org/10.1200/jco.2017.76.8192"},{"endpoint":"Event-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"All evaluable patients on the paediatric-inspired protocol","n":787,"value":52.2,"note":"95% CI 48.5 to 55.7; hyperfractionated cyclophosphamide did not change the rate"}],"source":"https://doi.org/10.1200/jco.2017.76.8192"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"All evaluable patients on the paediatric-inspired protocol","n":787,"value":58.5,"note":"95% CI 54.8 to 61.9"}],"source":"https://doi.org/10.1200/jco.2017.76.8192"},{"endpoint":"Event-free survival at 5 years by age","unit":"%","arms":[{"name":"Age under 55","value":55.7},{"name":"Age 55 and over","value":25.8}],"hr":2.16,"p":"<0.001","source":"https://doi.org/10.1200/jco.2017.76.8192"}]},{"id":"grid","kind":"trial","name":"GRID","aka":[],"tldr":"GRID showed that regorafenib held back GIST that had already escaped both imatinib and sunitinib, and gave patients a third line of targeted treatment.","summary":"GRID randomised 199 patients with metastatic or unresectable gastrointestinal stromal tumour that had progressed on imatinib and sunitinib two to one to regorafenib, a multikinase inhibitor of KIT, PDGFRA and VEGF receptors, or placebo, with crossover at progression. The primary endpoint was progression-free survival.\n\nRegorafenib lengthened progression-free survival several-fold compared with placebo, with disease control in most patients, at the cost of hand-foot skin reaction, hypertension and diarrhoea. Overall survival was confounded by crossover. Regorafenib was approved in the United States in February 2013 as third-line therapy for GIST and held that place until ripretinib arrived in 2020.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01271712","url":"https://clinicaltrials.gov/study/NCT01271712"}],"tags":["subtype-trials"],"related":[],"cancers":["gist-imatinib-resistant","gist","sarcoma"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["regorafenib"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["george-demetri"],"bottlenecks":[],"keyPapers":["paper-grid-regorafenib-gist-lancet-2013"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01271712","phase":"3","setting":"Metastatic or unresectable gastrointestinal stromal tumour after failure of imatinib and sunitinib: regorafenib against placebo","sponsor":"Bayer","result":"Regorafenib lengthened progression-free survival compared with placebo in GIST after imatinib and sunitinib; approved in February 2013.","started":"2011-01-04","startedType":"actual","yearReported":2013,"enrolled":199,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (independent blinded central review)","primary":true,"unit":"months","arms":[{"name":"Regorafenib","n":133,"value":4.8},{"name":"Placebo","n":66,"value":0.9}],"hr":0.27,"ci":[0.19,0.39],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(12)61857-1"}]},{"id":"nct05806385","kind":"trial","name":"Grouping Immune-modulation With Cryoablation (LOGIC) for Breast Cancers","aka":["LOGIC"],"tldr":"A phase 1/2 trial in triple-negative breast cancer, run by Texas Tech University Health Sciences Center, not yet recruiting.","summary":"Grouping Immune-modulation With Cryoablation (LOGIC) for Breast Cancers is a phase 1/2, randomised interventional study registered as NCT05806385 by Texas Tech University Health Sciences Center, with a registry enrolment figure of 36 participants, started 2026-03 and due to reach its primary completion in 2027-01. Interventions recorded: Cryoablation; Cryoablation combined with PD1 Inhibitor. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Diagnoses: Invasive carcinoma, ER -, PR-, HER2- (triple negative)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05806385","url":"https://clinicaltrials.gov/study/NCT05806385"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05806385","phase":"1/2","setting":"Local Therapy Optimization by Grouping Immune-modulation With Cryoablation (LOGIC) for High Risk Breast Cancers","sponsor":"Texas Tech University Health Sciences Center","started":"2026-03","startedType":"estimated","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06558773","kind":"trial","name":"GSL Synthetase Inhibitor Plus Immune Checkpoint Inhibitor and/or Regorafenib in Previously Treated pMMR/MSS CRC.","aka":[],"tldr":"A phase 2 trial of regorafenib in colorectal cancer, run by Chinese PLA General Hospital, now recruiting.","summary":"GSL Synthetase Inhibitor Plus Immune Checkpoint Inhibitor and/or Regorafenib in Previously Treated pMMR/MSS CRC. is a phase 2, randomised interventional study registered as NCT06558773 by Chinese PLA General Hospital, with a registry enrolment figure of 120 participants, started 2026-03-01 and due to reach its primary completion in 2027-03-01. Interventions recorded: Regorafenib+Immune checkpoint inhibitor; Eliglustat+Immune checkpoint inhibitor; Eliglustat+Immune checkpoint inhibitor +Regorafenib. Conditions listed: Colorectal Cancer. Primary outcome: Objective response rate (ORR). Colorectal eligibility wording from the registry: \"Histologically confirmed diagnosis of unresectable locally advanced, recurrent or metastatic colorectal cance have failed at least two lines of prior treatment\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06558773","url":"https://clinicaltrials.gov/study/NCT06558773"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["regorafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06558773","phase":"2","setting":"GSL Synthetase Inhibitor in Combination With Immune Checkpoint Inhibitor and/or Regorafenib for Patients With Advanced/Metastatic pMMR/MSS Colorectal Cancer:an Open-Label, Randomized,Phase II Study","sponsor":"Chinese PLA General Hospital","started":"2026-03-01","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06948981","kind":"trial","name":"GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies","aka":[],"tldr":"A phase 1/2 trial of GT719 Injection in non-Hodgkin lymphoma, run by Grit Biotechnology, now recruiting.","summary":"GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies is a phase 1/2 interventional study registered as NCT06948981 by Grit Biotechnology, with 46 participants planned, started 2025-04-18 and due to reach its primary completion in 2028-04-17. Interventions recorded: GT719 Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06948981","url":"https://clinicaltrials.gov/study/NCT06948981"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":["cd19"],"drugs":[],"companies":["grit-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06948981","phase":"1/2","setting":"A Single-arm, Open-label, Phase I/II Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies","sponsor":"Grit Biotechnology","started":"2025-04-18","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04652076","kind":"trial","name":"GYNecological Cancers Treated with NETrin MAbs in Combination with Chemotherapy and /or Pembrolizumab","aka":["GYNET"],"tldr":"A phase 1/2 trial of Pembrolizumab and Carboplatin in endometrial cancer and cervical cancer, run by NETRIS Pharma, active and no longer recruiting.","summary":"GYNecological Cancers Treated with NETrin MAbs in Combination with Chemotherapy and /or Pembrolizumab is a phase 1/2 interventional study registered as NCT04652076 by NETRIS Pharma, with 240 participants enrolled, started 2020-12-14 and due to reach its primary completion in 2025-10-30. Interventions recorded: NP137, Pembrolizumab, Paclitaxel and Carboplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04652076","url":"https://clinicaltrials.gov/study/NCT04652076"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial","cervical","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pembrolizumab","carboplatin","np137"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04652076","phase":"1/2","setting":"A Randomized, Multicenter, Open Label, Phase I/II Study to Evaluate the Safety, Clinical and Biological Activity of a Humanized Monoclonal Antibody Targeting Netrin-1 (NP137) in Combination with Carboplatin Plus Paclitaxel And/or Pembrolizumab in Patients with Locally Advanced/metastatic Endometrial Carcinoma or Cervix Carcinoma Progressing/relapsing After At Least One Prior Systemic Chemotherapy.","sponsor":"NETRIS Pharma","started":"2020-12-14","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07398664","kind":"trial","name":"H101 Plus TACE for r/m HNSCC","aka":[],"tldr":"A phase 2 trial of H101 oncolytic adenovirus in Head and neck squamous cell carcinoma, run by West China Hospital, now recruiting.","summary":"H101 Plus TACE for r/m HNSCC is a phase 2 interventional study registered as NCT07398664 by West China Hospital, with 20 participants planned, started 2026-03-02 and due to reach its primary completion in 2028-06-15. Interventions recorded: H101, TACE. Conditions recorded: Head and Neck Squamous Cell Carcinoma, Oncolytic Virus, TACE.\n\nLinked to the drug H101 oncolytic adenovirus because the registry names it among its interventions and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07398664","url":"https://clinicaltrials.gov/study/NCT07398664"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["h101-oncolytic-adenovirus"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07398664","phase":"2","setting":"Recombinant Human Adenovirus 5 (H101) Combined With Transcatheter Arterial Chemoembolization (TACE) for the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Single-Center, Prospective Study","sponsor":"West China Hospital","started":"2026-03-02","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03780049","kind":"trial","name":"HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B","aka":[],"tldr":"A phase 3 trial of H101 oncolytic adenovirus in Hepatocellular carcinoma, run by Sun Yat-sen University, with a status the registry has not verified recently.","summary":"HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B is a phase 3 interventional study registered as NCT03780049 by Sun Yat-sen University, with 304 participants planned, started 2018-10-01 and due to reach its primary completion in 2023-10-01. Interventions recorded: HAIC of FOLFOX, H101, Placebos. Conditions recorded: Hepatocellular Carcinoma.\n\nLinked to the drug H101 oncolytic adenovirus because the registry names it among its interventions and Hepatocellular carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03780049","url":"https://clinicaltrials.gov/study/NCT03780049"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":[],"targets":[],"drugs":["h101-oncolytic-adenovirus"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03780049","phase":"3","setting":"Hepatic Artery Infusion Chemotherapy Plus Recombinant Human Type-5 Adenovirus vs Hepatic Artery Infusion Chemotherapy Alone for Unresectable Hepatocellular Carcinoma at Barcelona Clinic Liver Cancer A-B Stage","sponsor":"Sun Yat-sen University","started":"2018-10-01","startedType":"actual","enrolled":304,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06389500","kind":"trial","name":"HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of adebrelimab and lenvatinib in gallbladder cancer and other biliary tract cancers, run by Harbin Medical University, not yet recruiting.","summary":"HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT06389500 by Harbin Medical University, with a registry enrolment figure of 30 participants, started 2024-05-01 and due to reach its primary completion in 2027-05-01. Interventions recorded: Adebrelimab, Lenvatinib, Hepatic Arterial Infusion Chemotherapy. Conditions listed: Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: \"3. Borderline resectable, locally advanced biliary malignant tumors, including gallbladder cancer, intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, and distal cholangiocarcinoma;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06389500","url":"https://clinicaltrials.gov/study/NCT06389500"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["adebrelimab","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06389500","phase":"2","setting":"Hepatic Arterial Infusion Chemotherapy Combined With Adebrelimab and Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer: a Single-arm, Exploratory Clinical Study","sponsor":"Harbin Medical University","started":"2024-05-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"halo-301","kind":"trial","name":"HALO 109-301","aka":["HALO-301","HALO 301"],"tldr":"HALO-301 was the phase 3 test of breaking down the dense stroma of pancreatic tumours with a hyaluronidase enzyme so chemotherapy could reach them; response rates went up but survival did not move, and the stroma-busting idea in this form was abandoned.","summary":"HALO 109-301 randomised 494 patients (492 analysed: 327 PEGPH20, 165 placebo) whose tumours were hyaluronan-high on a companion assay. Median overall survival was 11.2 months with PEGPH20 against 11.5 months with placebo (hazard ratio 1.00, 95 percent confidence interval 0.80 to 1.27; p 0.97), progression-free survival 7.1 months in both arms (hazard ratio 0.97) and objective response 47 against 36 percent (ratio 1.29). Grade 3 or worse fatigue (16.0 against 9.6 percent), muscle spasms (6.5 against 0.6) and hyponatraemia (8.0 against 3.8) were commoner with PEGPH20. The trial recruited at 15 UK sites (Cambridge, Peterborough, the Beatson Glasgow, Sarah Cannon London, Edinburgh, Clatterbridge, Birmingham, Castle Hill, Coventry, Hammersmith and the Royal Marsden among them). The authors concluded the results did not support further development in metastatic disease and Halozyme closed the programme in 2019.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02715804","url":"https://clinicaltrials.gov/study/NCT02715804"},{"label":"Van Cutsem et al., HALO 109-301 (JCO 2020)","url":"https://doi.org/10.1200/JCO.20.00590"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["pegvorhyaluronidase-alfa","gemcitabine-nab-paclitaxel"],"companies":["halozyme"],"institutions":[],"pathways":[],"terms":["desmoplasia","pancreatic-failed-programmes"],"trials":[],"people":["eric-van-cutsem"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 15): Addenbrooke's Cambridge; Peterborough; Beatson Glasgow; Sarah Cannon Research Institute UK London; Western General Edinburgh; Clatterbridge; Queen Elizabeth Birmingham; Castle Hill Cottingham; Coventry; Hammersmith; Royal Marsden Sutton and Chelsea, and others."],"nct":"NCT02715804","phase":"3","setting":"Untreated hyaluronan-high metastatic pancreatic ductal adenocarcinoma at sites in 22 countries: pegvorhyaluronidase alfa or placebo with nab-paclitaxel plus gemcitabine, randomised 2 to 1, double-blind, with overall survival as the primary endpoint","sponsor":"Halozyme Therapeutics","result":"Median overall survival 11.2 months with PEGPH20 plus nab-paclitaxel and gemcitabine against 11.5 months with placebo (hazard ratio 1.00, 95 percent confidence interval 0.80 to 1.27; p 0.97); progression-free survival 7.1 months in both arms; response 47 against 36 percent.","started":"2016-03-14","startedType":"actual","yearReported":2020,"enrolled":492,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"PEGPH20 + nab-paclitaxel + gemcitabine","n":327,"value":11.2},{"name":"Placebo + nab-paclitaxel + gemcitabine","n":165,"value":11.5}],"hr":1,"ci":[0.8,1.27],"p":"0.97","source":"https://doi.org/10.1200/JCO.20.00590"}]},{"id":"harmoni-2","kind":"trial","name":"HARMONi-2","aka":[],"tldr":"The first head-to-head trial in which a new drug beat Keytruda, in China; a survival benefit followed in 2026.","summary":"HARMONi-2, trial NCT05499390 sponsored by Akeso and reported in 2024, was the first head-to-head trial in which a new drug beat pembrolizumab, comparing the PD-1 by VEGF bispecific ivonescimab with pembrolizumab as first-line monotherapy for PD-L1-positive advanced non-small-cell lung cancer in China. It randomised 398 patients, met its primary progression-free survival endpoint by independent review with a substantial improvement, and in 2026 Akeso and Summit reported a statistically significant overall survival benefit. OnCo links it to PD-1 and VEGF as targets, to Michelle Xia, Qing Zhou and Caicun Zhou, and to HARMONi-A. It was a single-country trial and the global HARMONi-3 interim analysis did not reproduce the progression-free survival margin, so whether Western regulators accept the result rests on HARMONi-3 and HARMONi-7. Ivonescimab has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT05499390","url":"https://clinicaltrials.gov/study/NCT05499390"},{"label":"Summit press release (2026 OS)","url":"https://smmttx.com/news/press-releases/news-details/2026/Ivonescimab-Monotherapy-Demonstrates-Statistically-Significant-Overall-Survival-Benefit-Compared-to-Pembrolizumab-Monotherapy-in-PD-L1-Positive-Advanced-NSCLC-in-HARMONi-2-Study-Conducted-by-Akeso-in-China/default.aspx"}],"tags":[],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":["pd1","vegf"],"drugs":["ivonescimab","pembrolizumab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["xia-michelle","qing-zhou","zhou-caicun"],"bottlenecks":[],"keyPapers":["paper-harmoni-2-lancet-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05499390","phase":"3","setting":"First-line PD-L1-positive (TPS ≥1%) advanced NSCLC in China: ivonescimab vs pembrolizumab monotherapy","sponsor":"Akeso","result":"PFS HR 0.51; OS statistically significant (2026 announcement).","started":"2022-11-09","startedType":"actual","yearReported":2024,"enrolled":398,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (IRRC)","primary":true,"unit":"months","arms":[{"name":"Ivonescimab","n":198,"value":11.1},{"name":"Pembrolizumab","n":200,"value":5.8}],"hr":0.51,"ci":[0.38,0.69],"p":"<0.0001","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02722-3/fulltext"}],"replication":"Single-country (China) trial; OS immature. The global HARMONi-3 interim did not reproduce the PFS margin, so replication outside China is unresolved."},{"id":"harmoni-3","kind":"trial","name":"HARMONi-3","aka":[],"tldr":"The global test of whether ivonescimab plus chemotherapy beats the Keytruda-chemotherapy standard. An interim look in May 2026 fell short on progression; final results are due later in 2026.","summary":"Interim analysis (May 2026) did not reach statistical significance for PFS; the company expects final PFS and interim OS readouts in 2026. The FDA has set a PDUFA date of 14 November 2026 for a separate BLA based on HARMONi (EGFR-mutant, post-TKI), where the Western-subgroup OS hazard ratio improved to 0.76 without statistical significance.","status":"mixed","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT05899608","url":"https://clinicaltrials.gov/study/NCT05899608"},{"label":"Fierce Pharma on HARMONi OS update","url":"https://www.fiercepharma.com/pharma/summit-therapeutics-updates-ivonescimab-survival-data-ahead-fda-decision-date"}],"tags":[],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab","pembrolizumab"],"companies":["summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05899608","phase":"3","setting":"First-line metastatic squamous and non-squamous NSCLC, global: ivonescimab + chemotherapy vs pembrolizumab + chemotherapy","sponsor":"Summit Therapeutics","result":"Interim PFS not statistically significant (May 2026); final readouts pending.","started":"2023-10-26","startedType":"actual","yearReported":2026,"enrolled":1080,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (interim analysis, May 2026)","primary":true,"unit":"months","arms":[{"name":"Ivonescimab + chemotherapy","note":"Interim PFS analysis did not reach statistical significance per the sponsor (announced 30 April 2026); hazard ratio and medians not disclosed. Final PFS and OS analyses pending."},{"name":"Pembrolizumab + chemotherapy"}],"source":"https://clinicaltrials.gov/study/NCT05899608"}],"replication":"Ongoing; interim PFS analysis in 2026 did not meet significance per the sponsor; OS pending."},{"id":"harmoni-a","kind":"trial","name":"HARMONi-A","aka":[],"tldr":"The first phase 3 win for ivonescimab, in lung cancer that has stopped responding to EGFR pills, and the basis of its first approval in China.","summary":"322 patients. Median progression-free survival 7.1 versus 4.8 months (hazard ratio 0.46) with benefit across subgroups including patients who had received third-generation EGFR inhibitors; published in JAMA in 2024. NMPA approval May 2024, the first for any PD-1 x VEGF bispecific antibody. Summit's global HARMONi trial in the same setting met progression-free survival but not overall survival at its 2025 analysis, the basis of a US filing with a November 2026 action date.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT05184712","url":"https://clinicaltrials.gov/study/NCT05184712"},{"label":"JAMA 2024","url":"https://doi.org/10.1001/jama.2024.10613"}],"tags":["china"],"related":["harmoni-2","harmoni-3"],"cancers":["nsclc"],"sections":[],"technologies":["bispecific-antibody"],"targets":["pd1","vegf","egfr"],"drugs":["ivonescimab","pemetrexed","carboplatin"],"companies":["akeso","summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["fang-wenfeng","zhang-li-sysucc","xia-michelle"],"bottlenecks":[],"keyPapers":["paper-harmoni-a-jama-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05184712","phase":"3","setting":"EGFR-mutant non-squamous NSCLC after progression on an EGFR TKI, China: ivonescimab or placebo plus pemetrexed and carboplatin","sponsor":"Akeso","result":"PFS 7.1 vs 4.8 months, HR 0.46.","started":"2022-01-25","startedType":"actual","yearReported":2024,"enrolled":322,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Ivonescimab + chemotherapy","n":161,"value":7.1},{"name":"Placebo + chemotherapy","n":161,"value":4.8}],"hr":0.46,"source":"https://doi.org/10.1001/jama.2024.10613"}]},{"id":"nxc-201-mm","kind":"trial","name":"HBI0101 (NXC-201) multiple myeloma phase 1","aka":["HBI0101 phase 1","NXC-201 phase 1","MOH_2020-12-22_009584"],"tldr":"Hadassah's home-made BCMA CAR-T, now called NXC-201, produced responses in three quarters of heavily pretreated myeloma patients in its first 20-patient study, with only mild cytokine release and no nerve toxicity, showing that a hospital can manufacture its own CAR-T cells.","summary":"NCT04720313 is a phase 1 dose-escalation and safety study at Hadassah Medical Organization of HBI0101, a second-generation anti-BCMA CAR-T cell therapy developed and manufactured in an academic setting and infused fresh without cryopreservation, in relapsed or refractory BCMA-expressing multiple myeloma. Nexcella (now Immix Biopharma) is the collaborator and has taken the product forward as NXC-201.\n\nThe Haematologica 2023 report covers the first 20 heavily pretreated patients in three cohorts: 150 million CAR-T cells (6 patients), 450 million (7) and 800 million (7). Grade 1 or 2 cytokine release syndrome occurred in 18 patients (90 percent); there was no grade 3 or 4 cytokine release syndrome, no neurotoxicity of any grade and no dose-limiting toxicity in any cohort. The overall response rate was 75 percent, with a (stringent) complete response in 50 percent and a very good partial response in 25 percent. Responses were dose dependent: in the 800 million cohort the overall response rate was 85 percent, complete response 71 percent and minimal residual disease negativity 57 percent. Across cohorts the median overall survival was 308 days (range 25 to more than 466) and median progression-free survival 160 days at the June data cutoff, with six patients still progression free.\n\nThe registry lists the study as active, not recruiting, with an estimated 160 participants and a condition field reading \"Dose Escalation and Safety\" rather than a cancer, which is why the automated pass never attached it. The product's larger registered programme, NEXICART-2 (NCT06097832), is in AL amyloidosis and is a separate study.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04720313","url":"https://clinicaltrials.gov/study/NCT04720313"},{"label":"Haematologica 2023","url":"https://doi.org/10.3324/haematol.2022.281628"}],"tags":[],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["car-t"],"targets":["bcma"],"drugs":["nxc-201-car-t"],"companies":["immix-biopharma"],"institutions":["hadassah"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nxc-201-hbi0101-asherie-haematologica-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04720313","phase":"1","setting":"Relapsed or refractory BCMA-expressing multiple myeloma: academic autologous anti-BCMA CAR-T HBI0101 (now NXC-201), given fresh without cryopreservation, in a dose escalation of 150, 450 and 800 million CAR-T cells","sponsor":"Hadassah Medical Organization","result":"Overall response rate 75%, (stringent) complete response 50% and very good partial response 25% in the first 20 patients; grade 1 to 2 cytokine release syndrome in 90%, no grade 3 to 4 cytokine release syndrome or neurotoxicity; median progression-free survival 160 days.","started":"2021-01-01","startedType":"actual","yearReported":2023,"enrolled":20,"enrolledBasis":"treated","enrolledNote":"The Haematologica 2023 report covers the first 20 heavily pretreated patients treated across three dose cohorts (6, 7 and 7); ClinicalTrials.gov NCT04720313 lists an estimated enrolment of 160 for the continuing study.","outcomes":[{"endpoint":"Overall response rate","primary":true,"unit":"%","arms":[{"name":"HBI0101 (NXC-201), all dose cohorts","n":20,"value":75,"note":"(Stringent) complete response 50%, very good partial response 25%; 85% in the 800 million cell cohort (7 patients)"}],"source":"https://doi.org/10.3324/haematol.2022.281628"},{"endpoint":"(Stringent) complete response rate","unit":"%","arms":[{"name":"HBI0101 (NXC-201), all dose cohorts","n":20,"value":50,"note":"71% in the 800 million cell cohort, with 57% minimal residual disease negativity"}],"source":"https://doi.org/10.3324/haematol.2022.281628"},{"endpoint":"Median progression-free survival","unit":"days","arms":[{"name":"HBI0101 (NXC-201), all dose cohorts","n":20,"value":160,"note":"Median overall survival 308 days (range 25 to more than 466); six patients progression free at the data cutoff"}],"source":"https://doi.org/10.3324/haematol.2022.281628"},{"endpoint":"Grade 1 to 2 cytokine release syndrome","unit":"%","arms":[{"name":"HBI0101 (NXC-201), all dose cohorts","n":20,"value":90,"note":"18 of 20; no grade 3 to 4 cytokine release syndrome, no neurotoxicity of any grade, no dose-limiting toxicity"}],"source":"https://doi.org/10.3324/haematol.2022.281628"}],"replication":"Single-centre academic phase 1; the approved BCMA CAR-T products idecabtagene vicleucel and ciltacabtagene autoleucel reached registration through larger multicentre trials. NEXICART-2 (NCT06097832) tests the same cells in AL amyloidosis and has not reported."},{"id":"nct07169552","kind":"trial","name":"HC010 in First-line PD-L1 Positive Advanced NSCLC Patients","aka":[],"tldr":"A phase 2 trial of HC010 in non-small-cell lung cancer, run by HC Biopharma Inc., now recruiting.","summary":"HC010 in First-line PD-L1 Positive Advanced NSCLC Patients is a phase 2 interventional study registered as NCT07169552 by HC Biopharma Inc., with 50 participants planned, started 2025-12-09 and due to reach its primary completion in 2026-12-30. Interventions recorded: HC010.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07169552","url":"https://clinicaltrials.gov/study/NCT07169552"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":["pdl1"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07169552","phase":"2","setting":"A Multicenter, Single-arm, Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of HC010 for Injection in the First-line Treatment of Advanced Non-small Cell Lung Cancer Positive for Programmed Death Ligand-1 (PD-L1)","sponsor":"HC Biopharma Inc.","started":"2025-12-09","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06709885","kind":"trial","name":"HDAC Inhibitor Combination With Chemoimmunotherapy in the Neoadjuvant Treatment of pMMR Locally Advanced Colon Cancer","aka":[],"tldr":"A phase 2 trial of tucidinostat (chidamide), tislelizumab and cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, now recruiting.","summary":"HDAC Inhibitor Combination With Chemoimmunotherapy in the Neoadjuvant Treatment of pMMR Locally Advanced Colon Cancer is a phase 2, randomised interventional study registered as NCT06709885 by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, with a registry enrolment figure of 100 participants, started 2024-10-15 and due to reach its primary completion in 2025-09-30. Interventions recorded: Chidamide + Tislelizumab + chemotherapy (CapeOX ); CapeOX. Conditions listed: Colon Adenocarcinoma. Primary outcome: pCR. Colorectal eligibility wording from the registry: \"Patients with colon cancer who are assessed by abdominal contrast-enhanced CT/abdominopelvic MRI as high-risk T3 (tumor destroys muscle wall and extends to pericolonic fat, protruding more than 5 mm into adjacent mesenteric fat) or T4 (tumor penetrates the visceral peritoneal surface or directly inv\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06709885","url":"https://clinicaltrials.gov/study/NCT06709885"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["tucidinostat","tislelizumab","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06709885","phase":"2","setting":"HDAC Inhibitor Combination With Immunochemotherapy in the Neoadjuvant Treatment of pMMR Locally Advanced Colon Cancer: A Multicenter, Double-arm, Phase II Randomized Controlled Study","sponsor":"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","started":"2024-10-15","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07528768","kind":"trial","name":"HEADWATERS: Gemcitabine vs Paclitaxel in Metastatic Triple-Negative Breast Cancer in Women of African Ancestry.","aka":["HEADWATERS"],"tldr":"A phase 2 trial of gemcitabine in triple-negative breast cancer, run by The University of The West Indies, not yet recruiting.","summary":"HEADWATERS: Gemcitabine vs Paclitaxel in Metastatic Triple-Negative Breast Cancer in Women of African Ancestry. is a phase 2, randomised interventional study registered as NCT07528768 by The University of The West Indies, with a registry enrolment figure of 750 participants, started 2027-06-01 and due to reach its primary completion in 2034-06-01. Interventions recorded: Gemcitabine (1000 mg/m^2); Paclitaxel 80 mg/m2 weekly. Conditions listed: Triple Negative Breast Cancer; Metastatic Triple-negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Histologically confirmed metastatic triple-negative breast cancer (recent biopsy required)\". Sites: Barbados, Ghana, Jamaica. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07528768","url":"https://clinicaltrials.gov/study/NCT07528768"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07528768","phase":"2","setting":"Triple-Negative Breast Cancer From the West African Source to the Caribbean Diaspora: A Phase II Randomized Clinical Trial With Correlative Molecular and Population-Stratified Analysis in Women of African Ancestry With Metastatic Triple-Negative Breast Cancer.","sponsor":"The University of The West Indies","started":"2027-06-01","startedType":"estimated","enrolled":750,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05451602","kind":"trial","name":"HEC169096 in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of HEC169096 in advanced solid tumours, run by Sunshine Lake Pharma Co., Ltd., now recruiting.","summary":"HEC169096 in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05451602 by Sunshine Lake Pharma Co., Ltd., with 456 participants planned, started 2022-10-21 and due to reach its primary completion in 2026-12-30. Interventions recorded: HEC169096.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05451602","url":"https://clinicaltrials.gov/study/NCT05451602"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sunshine-lake-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05451602","phase":"1/2","setting":"Phase 1/2 Study of the Highly-selective RET Inhibitor,HEC169096 in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors","sponsor":"Sunshine Lake Pharma Co., Ltd.","started":"2022-10-21","startedType":"actual","enrolled":456,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05586074","kind":"trial","name":"HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML","aka":[],"tldr":"A phase 3 trial testing Clifutinib in acute myeloid leukaemia, now recruiting.","summary":"HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML is a phase 3 interventional study registered as NCT05586074, led by Sunshine Lake Pharma, and recruiting on the registry. Official title: HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukaemia: a Multicenter, Open-label, Randomised Phase 3 Trial. Planned enrolment is 324 participants (estimated). The study started in 2023-03-03 and primary completion is expected in 2027-11-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05586074","url":"https://clinicaltrials.gov/study/NCT05586074"}],"tags":["ctgov-ingest"],"related":[],"cancers":["aml","aml-flt3"],"sections":[],"technologies":[],"targets":[],"drugs":["clifutinib"],"companies":["sunshine-lake-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05586074","phase":"3","setting":"HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial","sponsor":"Sunshine Lake Pharma","started":"2023-03-03","startedType":"actual","enrolled":324,"enrolledBasis":"registry","outcomes":[]},{"id":"ucl-proton-hemithoracic-mpm","kind":"trial","name":"Hemithoracic irradiation with proton therapy in malignant pleural mesothelioma (UCL)","aka":[],"tldr":"The trial asking whether proton beams can deliver radiotherapy to the whole lining of one side of the chest in mesothelioma without the collateral damage that has kept hemithoracic radiotherapy out of routine care.","summary":"Radiotherapy to the entire hemithorax has repeatedly failed to help mesothelioma patients because the dose needed hits the heart, the remaining lung and the liver. Proton therapy stops sharply at a set depth, so it can cover the pleural surface with far less dose behind it. This University College London study, registered as NCT05655078 and recruiting since March 2024 with 148 patients planned, tests hemithoracic proton beam therapy in malignant pleural mesothelioma. It is the only proton therapy trial in mesothelioma on the registry.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05655078","url":"https://clinicaltrials.gov/study/NCT05655078"}],"tags":["owner-request"],"related":[],"cancers":["mesothelioma"],"sections":[],"technologies":["proton-therapy"],"targets":[],"drugs":[],"companies":[],"institutions":["uclh"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05655078","phase":"2","setting":"Malignant pleural mesothelioma; hemithoracic proton beam therapy to the whole pleural surface, a technique that protects the heart, opposite lung and liver better than photon radiotherapy; started March 2024, 148 planned","sponsor":"University College London","started":"2024-03-28","startedType":"actual","enrolled":148,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07764497","kind":"trial","name":"Hepatic Arterial Infusion Chemotherapy in Patients With Inoperable Colorectal Cancer Liver Metastasis","aka":["HAIP-6192"],"tldr":"A phase 2 trial of floxuridine in colorectal cancer, run by Sunnybrook Health Sciences Centre, now recruiting.","summary":"Hepatic Arterial Infusion Chemotherapy in Patients With Inoperable Colorectal Cancer Liver Metastasis is a phase 2, interventional study registered as NCT07764497 by Sunnybrook Health Sciences Centre, with a registry enrolment figure of 200 participants, started 2014-07 and due to reach its primary completion in 2036-12. Interventions recorded: Floxuridine (FUDR). Conditions listed: Colorectal Adenocarcinoma Metastatic in the Liver; Liver Metastasis Colon Cancer; Liver Metastases From Colorectal Cancer; Liver Metastases of Colorectal Cancer. Primary outcome: Proportion of participants that undergo liver resection following treatment with FUDR. Colorectal eligibility wording from the registry: \"History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07764497","url":"https://clinicaltrials.gov/study/NCT07764497"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["floxuridine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07764497","phase":"2","setting":"A Phase II Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Best Systemic Chemotherapy in Patients With Inoperable Hepatic Metastasis From Colorectal Cancer","sponsor":"Sunnybrook Health Sciences Centre","started":"2014-07","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07636798","kind":"trial","name":"Hepatic Arterial Infusion Chemotherapy Plus Envafolimab and Lenvatinib for First-Line Unresectable Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 1/2 trial of envafolimab and lenvatinib in gallbladder cancer and other biliary tract cancers, run by West China Hospital, now recruiting.","summary":"Hepatic Arterial Infusion Chemotherapy Plus Envafolimab and Lenvatinib for First-Line Unresectable Advanced Biliary Tract Cancer is a phase 1/2 interventional study registered as NCT07636798 by West China Hospital, with a registry enrolment figure of 20 participants, started 2026-06 and due to reach its primary completion in 2029-03. Interventions recorded: HAIC Combined Regimen Treatment Group. Conditions listed: Biliary Tract Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07636798","url":"https://clinicaltrials.gov/study/NCT07636798"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["envafolimab","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07636798","phase":"1/2","setting":"Safety and Efficacy of Hepatic Arterial Infusion Chemotherapy (GP Regimen) and Intra-arterial Infusion of Envafolimab Combined With Lenvatinib for Unresectable Advanced First-line Biliary Tract Cancer: A Multicenter, Phase Ib/II, Single-arm Clinical Study","sponsor":"West China Hospital","started":"2026-06","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03364530","kind":"trial","name":"Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma","aka":["GEMOXIA-02"],"tldr":"A phase 2 trial of gemcitabine and oxaliplatin in gallbladder cancer and other biliary tract cancers, run by University Hospital, Montpellier, now recruiting.","summary":"Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma is a phase 2 interventional study registered as NCT03364530 by University Hospital, Montpellier, with a registry enrolment figure of 40 participants, started 2018-06-11 and due to reach its primary completion in 2025-10-21. Interventions recorded: Gemcitabine-Oxaliplatin Regimen, Hepatic intra arterial chemotherapy. Conditions listed: Cholangiocarcinoma Non-resectable, Non-metastatic. Gallbladder cancer is named in the registry entry: \"* Patients with cholangiocarcinoma of the gallbladder or common bile duct or those with hepatocholangiocarcinoma or a Klatskin tumor\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03364530","url":"https://clinicaltrials.gov/study/NCT03364530"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine","oxaliplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03364530","phase":"2","setting":"Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma: a Multicentric Single-arm Phase II Study","sponsor":"University Hospital, Montpellier","started":"2018-06-11","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07570914","kind":"trial","name":"Hepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver Metastases","aka":[],"tldr":"A phase 2 trial of irinotecan (and liposomal irinotecan), fOLFOX (5-FU, leucovorin, oxaliplatin) and capecitabine in colorectal cancer, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"Hepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver Metastases is a phase 2, interventional study registered as NCT07570914 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 28 participants, started 2026-05-30 and due to reach its primary completion in 2027-05-30. Interventions recorded: Liposomal Irinotecan; Oxaliplatin; Capecitabine; hepatic arterial infusion chemotherapy (HAIC). Conditions listed: Colorectal Cancer Liver Metastases (CRLM); Colorectal Cancer; Liver Metastasis. Primary outcome: 3-Year Disease-Free Survival Rate. Colorectal eligibility wording from the registry: \"Completion of radical resection of the colorectal primary tumor and liver metastases within 12 weeks before enrollment, with postoperative imaging showing no residual lesion, recurrence, or extrahepatic metastasis, indicating no evidence of disease\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07570914","url":"https://clinicaltrials.gov/study/NCT07570914"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["irinotecan","folfox","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07570914","phase":"2","setting":"An Exploratory Clinical Study of Hepatic Arterial Infusion of Liposomal Irinotecan Combined With Oxaliplatin and Capecitabine as Postoperative Adjuvant Therapy for Colorectal Cancer Liver Metastases","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2026-05-30","startedType":"estimated","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07504471","kind":"trial","name":"Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen and Programmed Death-1 (PD-1) Inhibitors for Pancreatic Cancer Liver Metast","aka":["NaHCO3"],"tldr":"A phase 2 trial in pancreatic cancer, run by Ruijin Hospital, now recruiting.","summary":"Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen and Programmed Death-1 (PD-1) Inhibitors for Pancreatic Cancer Liver Metastases is a phase 2, interventional study registered as NCT07504471 by Ruijin Hospital, with a registry enrolment figure of 50 participants, started 2026-03-23 and due to reach its primary completion in 2026-12-31. Interventions recorded: pH-NASOX-Immune Group. Conditions listed: Pancreatic Neoplasms; Hepatic Metastasis of Pancreatic Cancer. Primary outcome: Overall Survival (OS). Pancreatic eligibility wording from the registry: \"* Pathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium), with metastasis to the liver;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07504471","url":"https://clinicaltrials.gov/study/NCT07504471"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07504471","phase":"2","setting":"A Prospective, Single-Center, Phase II Clinical Study of Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen (Liposomal Irinotecan, Oxaliplatin, and S-1) Hepatic Arterial Infusion Chemotherapy (HAIC) and Intra-Arterial Programmed Death-1 (PD-1) Inhibitors for Liver Metastases From Pancreatic Cancer","sponsor":"Ruijin Hospital","started":"2026-03-23","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06369831","kind":"trial","name":"HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011","aka":["HERMIA"],"tldr":"A phase 2 trial of an investigational treatment in advanced solid tumours, run by Abscint NV/SA, now recruiting.","summary":"HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011 is a phase 2 interventional study registered as NCT06369831 by Abscint NV/SA, with 60 participants planned, started 2024-09-12 and due to reach its primary completion in 2026-09.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06369831","url":"https://clinicaltrials.gov/study/NCT06369831"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["pet","pet-ct","her2-pet"],"targets":["her2"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06369831","phase":"2","setting":"Evaluating the Diagnostic Performance of Human Epidermal Growth Factor Receptor 2 (HER2) Targeted Positron Emission Tomography and Computed Tomography (PET/CT) With 68Ga-ABS011 in Metastatic Breast Cancer (mBC) and Other Metastatic Solid Carcinomas.","sponsor":"Abscint NV/SA","started":"2024-09-12","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"her2climb","kind":"trial","name":"HER2CLIMB","aka":[],"tldr":"The first trial to prove a drug helps HER2-positive brain metastases, extending survival by four and a half months overall.","summary":"HER2CLIMB, trial NCT02614794 sponsored by Seagen, now Pfizer, and reported in 2019, was the first trial to prove that a drug helps HER2-positive brain metastases, extending survival overall and in patients with brain disease. It randomised 612 women with HER2-positive metastatic breast cancer after trastuzumab, pertuzumab and trastuzumab emtansine, including 48 percent with active brain metastases, to tucatinib or placebo with trastuzumab and capecitabine, met its primary progression-free survival endpoint, improved overall survival and sharply reduced central nervous system progression, leading to approval in April 2020. OnCo links it to HER2 as a target, tucatinib, trastuzumab, the HER2-positive brain metastases term, Nancy U. Lin and the brain as a bottleneck. Whether systemic therapy should now come before local brain treatment is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02614794","url":"https://clinicaltrials.gov/study/NCT02614794"}],"tags":[],"related":[],"cancers":["breast-her2-positive","secondary-brain-tumours","her2-positive-breast-brain-metastases"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","kinase-inhibitors"],"targets":["her2"],"drugs":["tucatinib","trastuzumab"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":["her2-brain-metastases"],"trials":[],"people":["nancy-lin"],"bottlenecks":[],"keyPapers":["paper-her2climb-nejm-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02614794","phase":"2","setting":"HER2+ metastatic breast cancer after trastuzumab, pertuzumab, and T-DM1, including active brain metastases: tucatinib + trastuzumab + capecitabine vs placebo + trastuzumab + capecitabine","sponsor":"Seagen (Pfizer)","result":"OS 21.9 vs 17.4 months, HR 0.66; CNS-PFS HR 0.32.","started":"2016-01-28","startedType":"actual","yearReported":2019,"enrolled":612,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Tucatinib arm","n":320,"value":7.8},{"name":"Placebo arm","n":160,"value":5.6}],"hr":0.54,"ci":[0.42,0.71],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1914609"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Tucatinib arm","value":21.9},{"name":"Placebo arm","value":17.4}],"hr":0.66,"ci":[0.5,0.88],"p":"0.005","source":"https://doi.org/10.1056/NEJMoa1914609"}],"replication":"Tucatinib's CNS activity replicated in HER2CLIMB-02 (with T-DM1) and its efficacy in HER2CLIMB-05 (first-line maintenance)."},{"id":"her2climb-02","kind":"trial","name":"HER2CLIMB-02","aka":[],"tldr":"Adding tucatinib to Kadcyla helped a little, mostly in patients with brain metastases, but did not extend survival.","summary":"HER2CLIMB-02, trial NCT03975647 sponsored by Seagen, now Pfizer, and reported in 2023, tested adding tucatinib to trastuzumab emtansine in HER2-positive metastatic breast cancer after trastuzumab and a taxane, and found a small progression-free survival benefit, mostly in patients with brain metastases, without an improvement in overall survival. It randomised 463 women and met its primary progression-free survival endpoint with a modest effect, larger in the brain metastasis subgroup, but the combination has been superseded by trastuzumab deruxtecan in the second line and by HER2CLIMB-05 in maintenance. OnCo links it to tucatinib and trastuzumab emtansine, and the result is consistent with the central nervous system signal seen in HER2CLIMB. Whether tucatinib adds anything to newer antibody-drug conjugates for brain metastases is the open question. Tucatinib has its own page.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03975647","url":"https://clinicaltrials.gov/study/NCT03975647"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-breast-brain-metastases"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["tucatinib","trastuzumab-emtansine"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-her2climb-02-ann-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03975647","phase":"3","setting":"HER2+ metastatic breast cancer after trastuzumab and taxane: tucatinib + T-DM1 vs placebo + T-DM1","sponsor":"Seagen (Pfizer)","result":"PFS 9.5 vs 7.4 months, HR 0.76; OS no benefit.","started":"2019-10-02","startedType":"actual","yearReported":2023,"enrolled":466,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Tucatinib + T-DM1","value":9.5},{"name":"Placebo + T-DM1","value":7.4}],"hr":0.76,"ci":[0.61,0.95],"source":"https://www.onclive.com/view/tucatinib-combinations-in-her2-breast-cancer-her2climb-02-and-her2climb-05"}],"replication":"Consistent with HER2CLIMB's CNS signal."},{"id":"her2climb-05","kind":"trial","name":"HER2CLIMB-05","aka":[],"tldr":"In HER2CLIMB-05, adding the brain-penetrant pill tucatinib to maintenance antibodies after first-line chemotherapy delayed progression by more than eight months.","summary":"HER2CLIMB-05, trial NCT05132582 sponsored by Pfizer and reported at SABCS 2025, showed that adding the brain-penetrant tablet tucatinib to maintenance trastuzumab and pertuzumab after first-line induction chemotherapy for HER2-positive metastatic breast cancer delayed progression by more than eight months. It randomised 654 women to tucatinib or placebo with the two antibodies after taxane induction and met its primary progression-free survival endpoint with a benefit consistent across brain metastasis and hormone receptor subgroups, offering a chemotherapy-free intensification of maintenance. OnCo links it to tucatinib, trastuzumab and pertuzumab, and the result is consistent with HER2CLIMB. Overall survival is pending, and its place against first-line trastuzumab deruxtecan plus pertuzumab from DESTINY-Breast09 is unsettled, which is the open question. Tucatinib has its own page.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05132582","url":"https://clinicaltrials.gov/study/NCT05132582"},{"label":"JCO","url":"https://ascopubs.org/doi/10.1200/JCO-25-02600"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-breast-brain-metastases"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["tucatinib","trastuzumab","pertuzumab"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-her2climb-05-j-clin-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05132582","phase":"3","setting":"First-line HER2+ metastatic breast cancer after induction with taxane + trastuzumab + pertuzumab: maintenance tucatinib + HP vs placebo + HP","sponsor":"Pfizer","result":"PFS 24.9 vs 16.3 months, HR 0.64.","started":"2022-03-07","startedType":"actual","yearReported":2025,"enrolled":654,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Tucatinib + trastuzumab + pertuzumab","value":24.9},{"name":"Placebo + trastuzumab + pertuzumab","value":16.3}],"hr":0.641,"p":"<0.0001","source":"https://www.aacr.org/about-the-aacr/newsroom/news-releases/adding-tucatinib-to-first-line-maintenance-therapy-delayed-disease-progression-in-her2-positive-metastatic-breast-cancer-in-her2climb-05-trial/"}],"replication":"Consistent with HER2CLIMB; OS pending."},{"id":"hera-b31-n9831","kind":"trial","name":"HERA, NSABP B-31 & NCCTG N9831 (adjuvant trastuzumab)","aka":[],"tldr":"Three trials reported together in 2005 showed that a year of trastuzumab after surgery cuts the risk of dying from HER2-positive breast cancer by about a third.","summary":"HERA, NSABP B-31 and NCCTG N9831, led by trial NCT00045032 and sponsored by BIG, NSABP and NCCTG, were three adjuvant trials reported together in 2005 that showed a year of trastuzumab after surgery cuts the risk of dying from HER2-positive breast cancer by about a third. Across roughly 9,000 women the joint B-31 and N9831 analysis and the HERA trial both showed large, durable improvements in disease-free and overall survival at ten and eleven years despite heavy crossover in HERA, turning the worst breast cancer subtype into one of the most curable, and HERA also showed that two years of trastuzumab is no better than one. OnCo links them to HER2 as a target, trastuzumab, Barbara Bradfield, Norman Wolmark, Charles E. Geyer Jr., David Cameron, Martine Piccart and the NSABP Foundation. Whether shorter courses can match a year, as PERSEPHONE later asked, is the question that followed.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00045032","url":"https://clinicaltrials.gov/study/NCT00045032"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["her2"],"drugs":["trastuzumab"],"companies":["nsabp-foundation"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["barbara-bradfield","norman-wolmark","charles-geyer","david-cameron","martine-piccart"],"bottlenecks":[],"keyPapers":["paper-hera-b31-n9831-n-engl-j-med-2005","paper-hera-b31-n9831-lancet-2017-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00045032","phase":"3","setting":"Adjuvant HER2+ early breast cancer: one year of trastuzumab with or after chemotherapy vs chemotherapy alone","sponsor":"BIG / NSABP / NCCTG","result":"B-31/N9831 10-year OS 84% vs 75.2%, HR 0.63.","started":"2001-11","yearReported":2005,"enrolled":9000,"enrolledBasis":"registry","outcomes":[{"endpoint":"10-year overall survival (B-31/N9831)","unit":"%","arms":[{"name":"Chemotherapy + trastuzumab","n":2028,"value":84},{"name":"Chemotherapy alone","n":2018,"value":75.2}],"hr":0.63,"ci":[0.54,0.73],"source":"https://ascopubs.org/doi/10.1200/JCO.2014.55.5730"},{"endpoint":"Disease-free survival (B-31/N9831)","primary":true,"arms":[{"name":"Chemotherapy + trastuzumab"},{"name":"Chemotherapy alone"}],"hr":0.6,"ci":[0.53,0.68],"source":"https://doi.org/10.1056/NEJMoa052122"}],"replication":"Four independent adjuvant trials (HERA, B-31, N9831, BCIRG 006) all positive."},{"id":"heracles","kind":"trial","name":"HERACLES","aka":[],"tldr":"HERACLES showed that the breast cancer drugs trastuzumab and lapatinib, used together, could shrink bowel cancers that carry extra copies of the HER2 gene, turning a laboratory prediction into a treatment for this small group of patients.","summary":"Work in patient-derived xenografts had shown that HER2-amplified colorectal cancers respond to dual HER2 blockade. HERACLES was an Italian proof-of-concept phase 2 trial that screened KRAS wild-type metastatic colorectal cancers for HER2 amplification and treated those found, after failure of standard therapies including cetuximab or panitumumab, with trastuzumab plus lapatinib (cohort A). A second cohort tested pertuzumab with trastuzumab emtansine.\n\nIn cohort A roughly a third of the heavily pretreated patients had an objective response and responses lasted for many months, establishing HER2 amplification as an actionable target in colorectal cancer and setting up the later MyPathway, MOUNTAINEER and DESTINY-CRC trials.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03225937","url":"https://clinicaltrials.gov/study/NCT03225937"}],"tags":["subtype-trials"],"related":[],"cancers":["her2-amplified-colorectal","colorectal"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["trastuzumab","lapatinib","pertuzumab","trastuzumab-emtansine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["andrea-sartore-bianchi","salvatore-siena"],"bottlenecks":[],"keyPapers":["paper-sartore-bianchi-heracles-trastuzumab-lapatinib-lancet-oncol-2016","paper-valtorta-her2-scoring-colorectal-heracles-mod-pathol-2015","paper-bertotti-xenopatients-her2-cetuximab-resistant-colorectal-cancer-discov-2011","paper-richman-her2-amplification-quasar-focus-piccolo-j-pathol-2016"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03225937","phase":"2","setting":"HER2-amplified, KRAS wild-type metastatic colorectal cancer refractory to standard therapy: trastuzumab plus lapatinib (cohort A), and pertuzumab plus trastuzumab emtansine (cohort B)","sponsor":"Fondazione del Piemonte per l'Oncologia (Candiolo)","result":"Trastuzumab plus lapatinib produced objective responses in roughly a third of refractory HER2-amplified colorectal cancers.","started":"2012-08","yearReported":2016,"enrolled":54,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response (independent central review)","primary":true,"unit":"%","arms":[{"name":"Trastuzumab + lapatinib","n":27,"value":30,"note":"95% CI 14 to 50; median follow-up 94 weeks"}],"source":"https://doi.org/10.1016/S1470-2045(16)00150-9"},{"endpoint":"Stable disease","unit":"%","arms":[{"name":"Trastuzumab + lapatinib","n":27,"value":44}],"source":"https://doi.org/10.1016/S1470-2045(16)00150-9"},{"endpoint":"Grade 3 adverse events","unit":"%","arms":[{"name":"Trastuzumab + lapatinib","n":27,"value":22,"note":"No grade 4 or 5 events"}],"source":"https://doi.org/10.1016/S1470-2045(16)00150-9"}]},{"id":"herby","kind":"trial","name":"HERBY","aka":[],"tldr":"HERBY asked whether adding the anti-blood-vessel antibody bevacizumab to radiotherapy and temozolomide would help children with high-grade brain tumours; it did not delay the tumours returning, so the drug is not part of standard treatment for these children.","summary":"HERBY was an open-label randomised phase 2 trial in children and adolescents with newly diagnosed high-grade glioma outside the brainstem. After surgery, patients received radiotherapy with concurrent and adjuvant temozolomide, with or without bevacizumab.\n\nAdding bevacizumab did not improve event-free survival, the primary endpoint, as judged by central review, and did not improve overall survival. The trial did produce one of the best-characterised molecular cohorts of paediatric high-grade glioma; its biology sub-study showed that histone H3 and IDH mutation status, rather than histology, separated the outcomes, which fed into the WHO classification of these tumours.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01390948","url":"https://clinicaltrials.gov/study/NCT01390948"}],"tags":["subtype-trials"],"related":[],"cancers":["paediatric-high-grade-glioma","glioblastoma"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["bevacizumab","temozolomide"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jacques-grill"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01390948","phase":"2","setting":"Newly diagnosed non-brainstem high-grade glioma in children and adolescents aged 3 to 18: radiotherapy with temozolomide, with or without bevacizumab","sponsor":"Roche","result":"Bevacizumab added to radiotherapy and temozolomide did not improve event-free survival in newly diagnosed paediatric high-grade glioma.","started":"2011-10-18","startedType":"actual","yearReported":2018,"enrolled":124,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival (central radiology review)","primary":true,"unit":"months","arms":[{"name":"Bevacizumab + radiotherapy + temozolomide","n":62,"value":8.2},{"name":"Radiotherapy + temozolomide","n":59,"value":11.8}],"hr":1.44,"p":"0.13","source":"https://doi.org/10.1200/jco.2017.76.0611"},{"endpoint":"Overall survival","arms":[{"name":"Bevacizumab + radiotherapy + temozolomide","n":62,"note":"Medians not reported in the abstract"},{"name":"Radiotherapy + temozolomide","n":59}],"hr":1.23,"ci":[0.72,2.09],"source":"https://doi.org/10.1200/jco.2017.76.0611"},{"endpoint":"Serious adverse events","unit":"%","arms":[{"name":"Bevacizumab + radiotherapy + temozolomide","n":62,"value":58},{"name":"Radiotherapy + temozolomide","n":59,"value":48}],"source":"https://doi.org/10.1200/jco.2017.76.0611"}]},{"id":"herizon-btc-01","kind":"trial","name":"HERIZON-BTC-01","aka":[],"tldr":"The trial behind the first HER2 drug approved for bile duct and gallbladder cancer: zanidatamab shrank tumours in 41 percent of 80 people with HER2-positive disease that had progressed on chemotherapy, and more than half of those enrolled had gallbladder cancer. It led to approvals in the United States, the European Union and the UK, where NICE recommended it in May 2026.","summary":"HERIZON-BTC-01 (NCT04466891) is a global, multicentre, single-arm phase 2b at 32 sites in nine countries, including three London hospitals (University College London Hospitals, the Royal Free and Imperial). Between September 2020 and March 2022 it enrolled 87 patients with HER2-amplified biliary tract cancer confirmed by central in-situ hybridisation after progression on gemcitabine-based therapy: 80 in cohort 1 (HER2 IHC 2+ or 3+) and 7 in cohort 2 (IHC 0 or 1+). By the FDA label, 53 percent had gallbladder cancer, 27 percent intrahepatic and 19 percent extrahepatic cholangiocarcinoma, making it the trial with the largest gallbladder share of any approval study in the field. Confirmed objective response by independent central review in cohort 1, the primary endpoint, was 41.3 percent (33 of 80; 95 percent confidence interval 30.4 to 52.8) at a median follow-up of 12.4 months; 18 percent had grade 3 treatment-related adverse events (diarrhoea 5 percent, reduced ejection fraction 3 percent), with no grade 4 events or treatment-related deaths. Final results appeared in JAMA Oncology in 2026 and a post-hoc analysis reported survival by HER2 expression. The FDA granted accelerated approval in November 2024 for previously treated HER2-positive (IHC 3+) biliary tract cancer, the European Commission conditional approval on 27 June 2025, the MHRA approval on 19 February 2026, and NICE TA1153 (7 May 2026) recommends it for HER2-positive (IHC 3+) unresectable or metastatic biliary tract cancer after at least one line of systemic treatment, with FOLFOX or active symptom control as the comparators the committee considered. The randomised first-line HERIZON-BTC-302 trial is the confirmatory study.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04466891","url":"https://clinicaltrials.gov/study/NCT04466891"},{"label":"Harding et al., Lancet Oncology 2023: HERIZON-BTC-01","url":"https://doi.org/10.1016/S1470-2045(23)00242-5"},{"label":"Final results from HERIZON-BTC-01, JAMA Oncology 2026","url":"https://doi.org/10.1001/jamaoncol.2025.4736"},{"label":"Ziihera label (openFDA)","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ZIIHERA%22"},{"label":"NICE TA1153: zanidatamab for HER2-positive advanced biliary tract cancer (7 May 2026)","url":"https://www.nice.org.uk/guidance/ta1153"}],"tags":[],"related":["herizon-btc-302"],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["bispecific-antibody"],"targets":["her2"],"drugs":["zanidatamab"],"companies":["jazz","zymeworks","beone"],"institutions":["uclh"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-harding-lancet-oncol","paper-angerilli-her2-ihc-cish-biliary-hum-pathol-2026"],"journals":[],"dependsOn":[],"notes":["Key figures: 87 enrolled at 32 sites in nine countries (80 in cohort 1, HER2 IHC 2+ or 3+); confirmed response by independent central review 41.3 percent (33 of 80; 30.4 to 52.8) at a median follow-up of 12.4 months; grade 3 treatment-related adverse events 18 percent (diarrhoea 5, reduced ejection fraction 3), no grade 4 or treatment-related deaths. Approvals: FDA accelerated November 2024 (IHC 3+), European Commission conditional 27 June 2025, MHRA 19 February 2026, NICE TA1153 7 May 2026 (HER2 IHC 3+, after at least one line, commercial arrangement; FOLFOX or active symptom control as comparators).","UK sites (3, registry): University College London Hospitals, Royal Free London, Imperial College Healthcare (all London).","Tumour type split from the Ziihera label: gallbladder cancer 53%, intrahepatic cholangiocarcinoma 27%, extrahepatic cholangiocarcinoma 19%."],"nct":"NCT04466891","phase":"2","setting":"HER2-amplified unresectable, locally advanced or metastatic biliary tract cancer after gemcitabine-based therapy: zanidatamab 20 mg/kg every 2 weeks, single arm; cohort 1 IHC 2+ or 3+ (n=80), cohort 2 IHC 0 or 1+ (n=7)","sponsor":"Jazz Pharmaceuticals (Zymeworks, BeOne)","result":"Confirmed ORR by independent central review 41.3% (33/80, 95% CI 30.4 to 52.8) in HER2 IHC 2+/3+ cohort; grade 3 treatment-related adverse events 18%; 53% of patients had gallbladder cancer.","started":"2020-10-01","startedType":"actual","yearReported":2023,"enrolled":87,"enrolledBasis":"registry","outcomes":[{"endpoint":"Grade 3 treatment-related adverse events","unit":"%","arms":[{"name":"Zanidatamab","n":87,"value":18}],"source":"https://doi.org/10.1016/S1470-2045(23)00242-5"}]},{"id":"herizon-btc-302","kind":"trial","name":"HERIZON-BTC-302","aka":[],"tldr":"Tests whether the HER2 bispecific antibody should be given from the start in HER2-positive bile duct cancer.","summary":"HERIZON-BTC-302, trial NCT06282575 sponsored by Jazz and Zymeworks, tests whether the HER2 bispecific antibody zanidatamab should be given from the start in HER2-positive advanced biliary tract cancer, added to gemcitabine and cisplatin with or without PD-1 blockade. It is the confirmatory trial for zanidatamab's accelerated approval, which rested on the single-arm HERIZON-BTC-01 study, where about forty percent of patients responded and those with the highest HER2 expression responded most often; enrolment has been under way since 2024 with no results. OnCo links it to biliary tract and gallbladder cancer, HER2 as a target, zanidatamab and gemcitabine plus cisplatin. Whether HER2-directed therapy moves from later lines into first-line treatment for this rare subgroup is the question it will answer.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06282575","url":"https://clinicaltrials.gov/study/NCT06282575"},{"label":"Post-hoc HERIZON-BTC-01 analysis","url":"https://www.ccanewsonline.com/issues/2026/march-2026-vol-7-no-1/zanidatamab-improves-survival-outcomes-in-her2-positive-biliary-tract-cancer-post-hoc-herizon-btc-01-analysis"}],"tags":[],"related":[],"cancers":["cholangiocarcinoma","gallbladder"],"sections":[],"technologies":["bispecific-antibody"],"targets":["her2"],"drugs":["zanidatamab","gemcitabine-cisplatin"],"companies":["jazz","zymeworks"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Gallbladder cancer: the confirmatory first-line trial for zanidatamab; 286 patients planned, primary completion 2028-12-01 (registry). UK sites (5): Mount Vernon Cancer Centre (London), Royal Marsden (London and Surrey), The Christie (Manchester), Western General Hospital Edinburgh Cancer Centre. Given that 53 percent of HERIZON-BTC-01 patients had gallbladder cancer, this is the phase 3 most likely to report a gallbladder-dominated HER2 result."],"nct":"NCT06282575","phase":"3","setting":"First-line HER2-positive advanced biliary tract cancer: zanidatamab + standard of care (GemCis ± PD-1) vs standard of care","sponsor":"Jazz / Zymeworks","started":"2024-07-19","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"herizon-gea-01","kind":"trial","name":"HERIZON-GEA-01","aka":[],"tldr":"A two-armed HER2 antibody beat Herceptin head-to-head as first-line treatment for HER2-positive stomach cancer, the first such win since 2010.","summary":"HERIZON-GEA-01, trial NCT05152147 sponsored by Jazz and BeOne and reported in 2026, showed that the two-armed HER2 antibody zanidatamab beats trastuzumab head to head as first-line treatment for HER2-positive advanced gastro-oesophageal adenocarcinoma, the first such win since ToGA in 2010. It randomised 914 patients to zanidatamab plus chemotherapy, with or without tislelizumab, or trastuzumab plus chemotherapy, met its primary progression-free survival endpoint in both zanidatamab arms and significantly improved overall survival, as published in the New England Journal of Medicine in 2026, with a supplemental licence application planned for the first half of 2026. It sets up zanidatamab as the HER2 agent of choice, and how trastuzumab deruxtecan fits after it is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05152147","url":"https://clinicaltrials.gov/study/NCT05152147"},{"label":"ASCO GI 2026 LBA285","url":"https://ascopubs.org/doi/10.1200/JCO.2026.44.2_suppl.LBA285"}],"tags":[],"related":[],"cancers":["gastric","esophageal"],"sections":[],"technologies":["bispecific-antibody"],"targets":["her2","pd1"],"drugs":["zanidatamab","trastuzumab","tislelizumab"],"companies":["jazz","beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05152147","phase":"3","setting":"First-line HER2-positive advanced gastro-oesophageal adenocarcinoma: zanidatamab + chemotherapy ± tislelizumab vs trastuzumab + chemotherapy","sponsor":"Jazz / BeOne","result":"PFS 12.4 vs 8.1 months (HR 0.63-0.65); OS significantly improved.","started":"2021-12-02","startedType":"actual","yearReported":2026,"enrolled":920,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Zanidatamab + chemotherapy + tislelizumab","value":12.4},{"name":"Zanidatamab + chemotherapy","value":12.4},{"name":"Trastuzumab + chemotherapy","value":8.1}],"source":"https://ascopubs.org/doi/10.1200/JCO.2026.44.2_suppl.LBA285"}],"replication":"First phase 3; consistent with phase 2 (ORR 76% first line)."},{"id":"hero","kind":"trial","name":"HERO","aka":["HERO","HERO trial","relugolix against leuprolide"],"tldr":"An androgen deprivation tablet that works faster than the standard injection, wears off faster when stopped, and halved the rate of heart attacks and strokes.","summary":"Luteinising hormone-releasing hormone agonists such as leuprolide cause a testosterone surge before they suppress, which is why an anti-androgen is given alongside them at the start, and they are given as depot injections that cannot be stopped. Relugolix is an oral gonadotrophin-releasing hormone antagonist and has neither problem.\n\nHERO randomised men with advanced prostate cancer 2:1 to relugolix 120 mg orally once daily or leuprolide by injection every 3 months for 48 weeks; 622 received relugolix and 308 leuprolide. Sustained castration through 48 weeks was achieved by 96.7 percent (95 percent confidence interval 94.9 to 97.9) on relugolix against 88.8 percent (84.6 to 91.8) on leuprolide, a difference of 7.9 percentage points (4.1 to 11.8), meeting non-inferiority and then superiority (p<0.001). Every other key secondary endpoint favoured relugolix (p<0.001). Castrate testosterone on day 4 was reached by 56.0 percent on relugolix and 0 percent on leuprolide.\n\nReversibility was measured in a subgroup of 184 men: mean testosterone 90 days after stopping was 288.4 ng/dL after relugolix and 58.6 ng/dL after leuprolide, which matters for a man having a defined course of hormone therapy alongside radiotherapy and hoping to recover.\n\nThe cardiovascular finding is the one that changed prescribing. Major adverse cardiovascular events occurred in 2.9 percent on relugolix and 6.2 percent on leuprolide, hazard ratio 0.46 (95 percent confidence interval 0.24 to 0.88). It is a secondary endpoint in a trial not powered for it, and the comparison is against an agonist rather than against no treatment, so it should be read as the best randomised cardiovascular signal available in androgen deprivation rather than as proof. It is the evidence NICE cited in TA995 when it recommended relugolix.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03085095","url":"https://clinicaltrials.gov/study/NCT03085095"},{"label":"HERO (New England Journal of Medicine 2020)","url":"https://doi.org/10.1056/NEJMoa2004325"},{"label":"NICE TA995: relugolix for treating hormone-sensitive prostate cancer","url":"https://www.nice.org.uk/guidance/ta995"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["relugolix","leuprolide"],"companies":["sumitomo-pharma"],"institutions":[],"pathways":[],"terms":["adt","hormone-therapy","castration-resistance"],"trials":["patch-transdermal-oestradiol","swog-9346"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03085095","phase":"3","setting":"Advanced prostate cancer needing androgen deprivation: oral relugolix 120 mg once daily against leuprolide by injection every 3 months for 48 weeks, randomised 2:1, with sustained testosterone suppression below 50 ng/dL through 48 weeks as the primary endpoint","sponsor":"Myovant Sciences","result":"Sustained castration through 48 weeks in 96.7 against 88.8 percent (difference 7.9 percentage points, 95 percent confidence interval 4.1 to 11.8, superior, p<0.001); castrate testosterone by day 4 in 56.0 against 0 percent; major adverse cardiovascular events 2.9 against 6.2 percent (hazard ratio 0.46, 0.24 to 0.88).","started":"2017-04-18","startedType":"actual","yearReported":2020,"enrolled":930,"enrolledBasis":"treated","enrolledNote":"622 men received relugolix and 308 received leuprolide, a 2:1 randomisation; the figure quoted is the treated population reported in the primary publication.","outcomes":[{"endpoint":"Sustained castration through 48 weeks","primary":true,"unit":"%","arms":[{"name":"Relugolix 120 mg orally daily","n":622,"value":96.7},{"name":"Leuprolide by injection every 3 months","n":308,"value":88.8}],"p":"<0.001 for superiority","source":"https://doi.org/10.1056/NEJMoa2004325"},{"endpoint":"Castrate testosterone on day 4","unit":"%","arms":[{"name":"Relugolix 120 mg orally daily","n":622,"value":56},{"name":"Leuprolide by injection every 3 months","n":308,"value":0}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa2004325"},{"endpoint":"Major adverse cardiovascular events","unit":"%","arms":[{"name":"Relugolix 120 mg orally daily","n":622,"value":2.9},{"name":"Leuprolide by injection every 3 months","n":308,"value":6.2}],"hr":0.46,"ci":[0.24,0.88],"source":"https://doi.org/10.1056/NEJMoa2004325"}],"replication":"Not independently replicated. PATCH, comparing transdermal oestradiol with a luteinising hormone-releasing hormone agonist in 1,694 men, found no difference in cardiovascular events (hazard ratio 1.11, 0.80 to 1.53), so the cardiovascular advantage reported here is specific to this comparison and should be read cautiously."},{"id":"nct04619004","kind":"trial","name":"HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer","aka":["HERTHENA-Lung01"],"tldr":"A phase 2 trial of Patritumab deruxtecan in non-small-cell lung cancer and small-cell lung cancer, run by Daiichi Sankyo, active and no longer recruiting.","summary":"HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT04619004 by Daiichi Sankyo, with 277 participants enrolled, started 2021-02-02 and due to reach its primary completion in 2022-11-21. Interventions recorded: Patritumab Deruxtecan (Fixed dose), Patritumab Deruxtecan (Up-Titration). Conditions listed: Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor. Results were posted on ClinicalTrials.gov in 2024; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04619004","url":"https://clinicaltrials.gov/study/NCT04619004"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["patritumab-deruxtecan"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04619004-j-clin-oncol-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04619004","phase":"2","setting":"HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Daiichi Sankyo","started":"2021-02-02","startedType":"actual","yearReported":2024,"enrolled":277,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)","primary":true,"unit":"participants","arms":[{"name":"Patritumab Deruxtecan 5.6 mg/kg","n":225,"value":64,"note":"Figures from the ClinicalTrials.gov results section (first posted 2024-04-02), not from a publication"},{"name":"Patritumab Deruxtecan Up-Titration","n":50,"value":8}],"source":"https://clinicaltrials.gov/study/NCT04619004?tab=results"}]},{"id":"herthena-lung02","kind":"trial","name":"HERTHENA-Lung02","aka":[],"tldr":"A HER3 ADC delayed progression by only a few days more than chemotherapy and did not extend survival, so its US application was withdrawn.","summary":"HERTHENA-Lung02, trial NCT05338970 sponsored by Daiichi Sankyo and Merck and reported in 2025, tested the HER3 antibody-drug conjugate patritumab deruxtecan against platinum chemotherapy in EGFR-mutant non-small-cell lung cancer after a third-generation EGFR inhibitor. It randomised 586 patients and met its primary progression-free survival endpoint, but the median gain over chemotherapy amounted to days and overall survival was no different, so the companies withdrew the accelerated approval application on 29 May 2025. OnCo links it to HER3 as a target and to Benjamin Besse, and records the trial as a lesson that antibody-drug conjugate activity after targeted therapy does not guarantee benefit over a platinum doublet, since the single-arm HERTHENA-Lung01 signal did not translate. Whether HER3 remains a viable target in this setting is the open question.","status":"mixed","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT05338970","url":"https://clinicaltrials.gov/study/NCT05338970"},{"label":"Merck: BLA withdrawn","url":"https://www.merck.com/news/patritumab-deruxtecan-biologics-license-application-for-patients-with-previously-treated-locally-advanced-or-metastatic-egfr-mutated-non-small-cell-lung-cancer-voluntarily-withdrawn/"}],"tags":[],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["adc"],"targets":["her3"],"drugs":["patritumab-deruxtecan"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["benjamin-besse"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05338970","phase":"3","setting":"EGFR-mutant NSCLC after third-generation TKI: patritumab deruxtecan vs platinum chemotherapy","sponsor":"Daiichi Sankyo / Merck","result":"PFS HR 0.77 (5.8 vs 5.4 months); OS not significant; BLA withdrawn.","started":"2022-07-08","startedType":"actual","yearReported":2025,"enrolled":586,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Patritumab deruxtecan","n":293,"value":5.8},{"name":"Platinum + pemetrexed","n":293,"value":5.4}],"hr":0.77,"ci":[0.63,0.94],"p":"0.011","source":"https://clinicaltrials.gov/study/NCT05338970"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Patritumab deruxtecan","value":16.8,"note":"Not significant"},{"name":"Platinum + pemetrexed","value":16.8}],"hr":0.98,"ci":[0.79,1.22],"source":"https://clinicaltrials.gov/study/NCT05338970"}],"replication":"Did not replicate the single-arm HERTHENA-Lung01 response signal into an OS benefit; the US filing was withdrawn."},{"id":"nct05864014","kind":"trial","name":"Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.","aka":[],"tldr":"A phase 3 trial of Hetrombopag in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., active and no longer recruiting.","summary":"Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors. is a phase 3 interventional study registered as NCT05864014 by Jiangsu HengRui Medicine Co., Ltd., with 213 participants enrolled, started 2023-04-25 and due to reach its primary completion in 2025-03-03. Interventions recorded: Hetrombopag, Hetrombopag plus Placebo and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05864014","url":"https://clinicaltrials.gov/study/NCT05864014"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05864014","phase":"3","setting":"Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hetrombopag for the Treatment of Chemotherapy-induced Thrombocytopenia in Adults With Solid Tumors.","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2023-04-25","startedType":"actual","enrolled":213,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07213375","kind":"trial","name":"High Dose Dexamethasone to Reduce Postoperative Pain After Video-Assisted Thoracoscopic Surgery Lobectomy /Segmentectomy","aka":["DEXTER"],"tldr":"A phase 2/3 trial of dexamethasone in lung cancer, run by Rigshospitalet, Denmark, now recruiting.","summary":"High Dose Dexamethasone to Reduce Postoperative Pain After Video-Assisted Thoracoscopic Surgery Lobectomy /Segmentectomy is a phase 2/3, randomised interventional study registered as NCT07213375 by Rigshospitalet, Denmark, with a registry enrolment figure of 80 participants, started 2025-09-01 and due to reach its primary completion in 2026-10. Interventions recorded: Dexamethasone. Conditions listed: Analgetic; Lung Cancer (NSCLC); Video Assisted Thoracic Surgery (VATS); Glucocorticoid. Primary outcome: Pain when coughing on the morning of first postoperative day.. Sites: Denmark. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07213375","url":"https://clinicaltrials.gov/study/NCT07213375"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["robotic-surgery"],"targets":[],"drugs":["dexamethasone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07213375","phase":"2/3","setting":"High Dose Dexamethasone In High-Pain Responders Undergoing Enhanced Recovery Video-Assisted Thoracoscopic Surgery Lobectomy and Segmentectomy - A Randomized Double-Blinded Controlled Trial","sponsor":"Rigshospitalet, Denmark","started":"2025-09-01","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00634322","kind":"trial","name":"High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma","aka":["HDMTX-LV"],"tldr":"A phase 2 trial of Glucarpidase and Leucovorin in Osteosarcoma, run by BTG International Inc., recorded as terminated on the registry.","summary":"High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma is a phase 2 interventional study registered as NCT00634322 by BTG International Inc., with 7 participants recorded, started 2008-10 and due to reach its primary completion in 2009-03. Interventions recorded: glucarpidase, leucovorin. Conditions recorded: Osteosarcoma.\n\nLinked to the drug Glucarpidase because the registry names it among its interventions and Osteosarcoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00634322","url":"https://clinicaltrials.gov/study/NCT00634322"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["osteosarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["glucarpidase","leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00634322","phase":"2","setting":"Randomized, Blinded, Placebo-Controlled Trial of High Dose Methotrexate With Leucovorin Rescue (HDMTX-LV) With or Without Glucarpidase in Osteosarcoma","sponsor":"BTG International Inc.","started":"2008-10","enrolled":7,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06492759","kind":"trial","name":"High Dose Radiation Therapy With Pembrolizumab and Chemotherapy for the Treatment of Patients With PD-L1 Positive Metastatic Triple Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of pembrolizumab, nab-paclitaxel, paclitaxel / nab-paclitaxel, carboplatin and other drugs in triple-negative breast cancer, run by Emory University, now recruiting.","summary":"High Dose Radiation Therapy With Pembrolizumab and Chemotherapy for the Treatment of Patients With PD-L1 Positive Metastatic Triple Negative Breast Cancer is a phase 2, interventional study registered as NCT06492759 by Emory University, with a registry enrolment figure of 29 participants, started 2025-10-22 and due to reach its primary completion in 2027-02-12. Interventions recorded: Radiation Therapy; Pembrolizumab; Nab-paclitaxel; Paclitaxel; Carboplatin; Gemcitabine; Biopsy; Computed Tomography; Bone Scan; Biospecimen Collection; Medical Chart Review. Conditions listed: Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Triple-Negative Breast Carcinoma. Triple-negative eligibility wording from the registry: \"* Biopsy proven metastatic PD-L1 positive triple negative breast cancer with at least 2 sites of measurable metastatic disease on imaging\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06492759","url":"https://clinicaltrials.gov/study/NCT06492759"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pembrolizumab","nab-paclitaxel","paclitaxel","carboplatin","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06492759","phase":"2","setting":"A Phase II Study of High Dose Radiotherapy in Combination With Pembrolizumab Plus Chemotherapy in Patients With PD-L1 Positive Metastatic Triple Negative Breast Cancer","sponsor":"Emory University","started":"2025-10-22","startedType":"actual","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03329183","kind":"trial","name":"High-dose FOLFIRI in Advanced Colorectal Cancer Patients With Wild-type UGT1A1*6 and *28","aka":[],"tldr":"A phase 2 trial of UGT1A1 genotyping before irinotecan in Colorectal cancer, run by Shanghai Changzheng Hospital, with a status the registry has not verified recently.","summary":"High-dose FOLFIRI in Advanced Colorectal Cancer Patients With Wild-type UGT1A1*6 and *28 is a phase 2 interventional study registered as NCT03329183 by Shanghai Changzheng Hospital, with 90 participants planned, started 2019-03 and due to reach its primary completion in 2019-03. Interventions recorded: Irinotecan. Conditions recorded: Colorectal Cancer.\n\nLinked to the technology UGT1A1 genotyping before irinotecan because the registry's title names it (\"ugt1a1 6\") and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03329183","url":"https://clinicaltrials.gov/study/NCT03329183"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["ugt1a1-genotyping"],"targets":[],"drugs":["irinotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03329183","phase":"2","setting":"High-dose FOLFIRI Versus Standard-dose FOLFIRI or FOLFOX-6 in Advanced Colorectal Cancer Patients With Wild-type UGT1A1*6 and *28: A Randomized, Opened, Phase II Clinical Trial","sponsor":"Shanghai Changzheng Hospital","started":"2019-03","startedType":"estimated","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04221035","kind":"trial","name":"High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)","aka":["HR-NBL2"],"tldr":"A phase 3 trial of Vincristine, Carboplatin, Etoposide, Vindesine, Dacarbazine, Ifosfamide, Doxorubicin, Busulfan, Melphalan, Thiotepa, Dinutuximab, Cisplatin and Irinotecan in High-risk neuroblastoma, run by Gustave Roussy, Cancer Campus, Grand Paris, now recruiting.","summary":"High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) is a phase 3 interventional study registered as NCT04221035 by Gustave Roussy, Cancer Campus, Grand Paris, with 800 participants planned, started 2019-11-05 and due to reach its primary completion in 2026-11. Interventions recorded: Vincristine, Carboplatin, Etoposide, Vindesine, Dacarbazine, Ifosfamide, Doxorubicin, Busulfan, Melphalan, Thiotepa, Radiotherapy, Dinutuximab Beta, Cisplatin, Temozolomide 100 MG, Irinotecan, Cyclophosphamid. Conditions recorded: High-Risk Neuroblastoma, Patient With Insufficient Response Chemoimmunotherapy.\n\nLinked to the drug Vindesine because the registry names it among its interventions and High-risk neuroblastoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04221035","url":"https://clinicaltrials.gov/study/NCT04221035"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroblastoma-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["vincristine","carboplatin","etoposide","vindesine","dacarbazine","ifosfamide","doxorubicin","busulfan","melphalan","thiotepa","dinutuximab","cisplatin","irinotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04221035","phase":"3","setting":"High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","started":"2019-11-05","startedType":"actual","enrolled":800,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05394103","kind":"trial","name":"Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in metastatic cancer, run by Qurient Co., Ltd., now recruiting.","summary":"Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05394103 by Qurient Co., Ltd., with 130 participants planned, started 2022-08-30 and due to reach its primary completion in 2025-12-30. Interventions recorded: Q901, KEYTRUDA® (pembrolizumab). Conditions listed: Advanced Cancer, Metastatic Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05394103","url":"https://clinicaltrials.gov/study/NCT05394103"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["qurient"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05394103","phase":"1/2","setting":"A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901Administered Via Intravenous Infusion as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Selected Advanced Solid Tumors With Cohort Expansions at the Recommended Phase 2 Dose","sponsor":"Qurient Co., Ltd.","started":"2022-08-30","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"hilo","kind":"trial","name":"HiLo","aka":[],"tldr":"Showed a third of the usual radioactive iodine dose ablates the thyroid remnant just as well, with fewer side effects and less time in isolation.","summary":"HiLo, trial NCT00415233 sponsored by Cancer Research UK and reported in 2012, showed that a third of the usual radioactive iodine dose ablates the thyroid remnant just as well as the high dose in differentiated thyroid cancer, with fewer side effects and less time in isolation. It randomised 438 patients needing ablation to 1.1 GBq or 3.7 GBq of radioiodine, with recombinant TSH or thyroid hormone withdrawal, and met its non-inferiority endpoint on successful ablation, while recombinant TSH avoided hypothyroid symptoms. OnCo links it to thyroid cancer, radioiodine therapy, radioactive iodine and Cancer Research UK, and the French ESTIMABL1 trial replicated low-dose non-inferiority at the same time. Low-dose ablation became standard for intermediate-risk disease and the trial paved the way to omitting ablation altogether in low-risk disease, as ESTIMABL2 and IoN then showed.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00415233","url":"https://clinicaltrials.gov/study/NCT00415233"},{"label":"NEJM 2012","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1109589"}],"tags":[],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["radioiodine-therapy"],"targets":[],"drugs":[],"companies":[],"institutions":["cruk"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00415233","phase":"3","setting":"Differentiated thyroid cancer needing ablation: low-dose (1.1 GBq) vs high-dose (3.7 GBq) radioiodine, with recombinant TSH or thyroid hormone withdrawal","sponsor":"Cancer Research UK","result":"Ablation success 85.0% (1.1 GBq) vs 88.9% (3.7 GBq), non-inferior.","started":"2006-11","startedType":"actual","yearReported":2012,"enrolled":438,"enrolledBasis":"registry","outcomes":[{"endpoint":"Successful ablation","primary":true,"unit":"%","arms":[{"name":"1.1 GBq","value":85},{"name":"3.7 GBq","value":88.9}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1109589"}],"replication":"ESTIMABL1 (France) replicated low-dose non-inferiority simultaneously."},{"id":"nct06849492","kind":"trial","name":"HIM Typing Guides the Treatment of Advanced First-Line Triple-Negative Breast Cancer","aka":["SHIFT-001"],"tldr":"A phase 2 trial of camrelizumab, nab-paclitaxel, sacituzumab tirumotecan and lenvatinib in triple-negative breast cancer, run by Fudan University, not yet recruiting.","summary":"HIM Typing Guides the Treatment of Advanced First-Line Triple-Negative Breast Cancer is a phase 2, interventional study registered as NCT06849492 by Fudan University, with a registry enrolment figure of 120 participants, started 2025-04-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: Camrelizumab; Nab-paclitaxel; SKB264; Lenvatinib. Conditions listed: Advanced Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Histopathologically confirmed recurrent metastatic triple-negative invasive breast cancer (HER2-negative: IHC 0/1+ or IHC 2+ with negative ISH; ER-negative: IHC \\<1%, PR-negative: IHC \\<1%)；\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06849492","url":"https://clinicaltrials.gov/study/NCT06849492"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["adc","checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["camrelizumab","nab-paclitaxel","sacituzumab-tirumotecan","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06849492","phase":"2","setting":"An Open, Multicenter Study on the Treatment of Recurrent and Metastatic Triple-negative Breast Cancer Guided by Cell Surface Protein Typing (HIM) in Triple-negative Breast Cancer","sponsor":"Fudan University","started":"2025-04-01","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"himalaya","kind":"trial","name":"HIMALAYA","aka":[],"tldr":"A single dose of a CTLA-4 antibody added to PD-L1 blockade doubled five-year survival in liver cancer without needing an anti-VEGF drug.","summary":"HIMALAYA, trial NCT03298451 sponsored by AstraZeneca and reported in 2022, showed that a single priming dose of the CTLA-4 antibody tremelimumab added to durvalumab, the STRIDE regimen, improves survival in first-line unresectable hepatocellular carcinoma compared with sorafenib without needing an anti-VEGF drug. It randomised 1,171 patients, met its primary overall survival endpoint, and its five-year update, the longest follow-up of any phase 3 in liver cancer, showed roughly twice as many long-term survivors with STRIDE, while durvalumab alone was non-inferior to sorafenib. OnCo links it to PD-L1 and CTLA-4 as targets, durvalumab, tremelimumab and Ghassan K. Abou-Alfa, and with no bleeding risk it is usable in patients with varices. The STRIDE plus TACE strategy is being tested in EMERALD-3, and how to choose between STRIDE and atezolizumab plus bevacizumab is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03298451","url":"https://clinicaltrials.gov/study/NCT03298451"},{"label":"HIMALAYA 5-year OS (PubMed)","url":"https://pubmed.ncbi.nlm.nih.gov/40222621/"}],"tags":[],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1","ctla4"],"drugs":["durvalumab","tremelimumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ghassan-abou-alfa"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03298451","phase":"3","setting":"First-line unresectable HCC: STRIDE (single priming dose tremelimumab + durvalumab) vs sorafenib","sponsor":"AstraZeneca","result":"OS HR 0.78; 5-year OS 19.6% vs 9.4%.","started":"2017-10-11","startedType":"actual","yearReported":2022,"enrolled":1171,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"STRIDE","n":393,"value":16.4},{"name":"Sorafenib","n":389,"value":13.8}],"hr":0.78,"ci":[0.66,0.92],"source":"https://doi.org/10.1056/EVIDoa2100070"},{"endpoint":"5-year overall survival","unit":"%","arms":[{"name":"STRIDE","value":19.6},{"name":"Sorafenib","value":9.4}],"hr":0.76,"source":"https://pubmed.ncbi.nlm.nih.gov/40222621/"}],"replication":"Five-year follow-up of the same trial; the STRIDE + TACE strategy is being tested in EMERALD-3."},{"id":"nct02448992","kind":"trial","name":"Hippocampal-Sparing Prophylactic Cranial Irradiation in Pathologically Nodal Positive Non-Small-Cell Lung Cancer","aka":[],"tldr":"A phase 2/3 trial in lung cancer, run by Chang Gung Memorial Hospital, now recruiting.","summary":"Hippocampal-Sparing Prophylactic Cranial Irradiation in Pathologically Nodal Positive Non-Small-Cell Lung Cancer is a phase 2/3, randomised interventional study registered as NCT02448992 by Chang Gung Memorial Hospital, with a registry enrolment figure of 90 participants, started 2015-08-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: hippocampal-sparing WBRT. Conditions listed: Non-Small-Cell Lung Cancer (NSCLC); Brain Metastasis. Primary outcome: time to the development of brain metastasis/metastases (BM), irrespective of the absence of active neurological symptoms. Lung eligibility wording from the registry: \"* Clinical diagnosis of NSCLC\". Sites: Taiwan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02448992","url":"https://clinicaltrials.gov/study/NCT02448992"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02448992","phase":"2/3","setting":"Neuropsychological and Oncological Outcomes After Hippocampal-Sparing Prophylactic Cranial Irradiation in Postoperative Patients With Pathologically Nodal Positive Non-Small-Cell Lung Cancer - A Prospective Follow-up Study","sponsor":"Chang Gung Memorial Hospital","started":"2015-08-01","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05810792","kind":"trial","name":"Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer","aka":["PANCEP-1"],"tldr":"A phase 2 trial of histamine dihydrochloride and aldesleukin (high-dose IL-2) in pancreatic cancer, run by Sahlgrenska University Hospital, not yet recruiting.","summary":"Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer is a phase 2, interventional study registered as NCT05810792 by Sahlgrenska University Hospital, with a registry enrolment figure of 50 participants, started 2024-04-01 and due to reach its primary completion in 2027-04-01. Interventions recorded: Histamine Dihydrochloride (HDC); Interleukin-2 (IL-2). Conditions listed: Pancreatic Cancer; Surgery; Metastasis; Immunosuppression. Primary outcome: Incidence and severity of Treatment-Emergent Adverse Events as assessed by NCI-CTCAE. Pancreatic eligibility wording from the registry: \"By the surgeon´s evaluation fit for pancreatic surgery\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05810792","url":"https://clinicaltrials.gov/study/NCT05810792"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["histamine-dihydrochloride","aldesleukin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05810792","phase":"2","setting":"A Phase I/II Trial of Peri- and Postoperative Treatment With Histamine Dihydrochloride and Low-dose Interleukin-2 in Patients With Primary Resectable Pancreatic Cancer","sponsor":"Sahlgrenska University Hospital","started":"2024-04-01","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04353375","kind":"trial","name":"HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma","aka":[],"tldr":"A phase 2/3 trial testing HMPL-453 in biliary tract cancer, now recruiting.","summary":"HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma is a phase 2/3 interventional study registered as NCT04353375, led by Hutchmed, and recruiting on the registry. Official title: An Open-Label, Single-Arm, Multicenter Phase 2/3b Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-453 Tartrate in Patients With Advanced Intrahepatic Cholangiocarcinoma Habouring FGFR2 Fusion/Rearrangement. Planned enrolment is 235 participants (estimated). The study started in 2020-09-03 and primary completion is expected in 2028-06-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04353375","url":"https://clinicaltrials.gov/study/NCT04353375"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["hmpl-453"],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04353375","phase":"2/3","setting":"An Open-Label, Single-Arm, Multicenter Phase 2/3b Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-453 Tartrate in Patients With Advanced Intrahepatic Cholangiocarcinoma Habouring FGFR2 Fusion/Rearrangement","sponsor":"Hutchmed","started":"2020-09-03","startedType":"actual","enrolled":235,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07396584","kind":"trial","name":"HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor","aka":[],"tldr":"A phase 1/2 trial of HMPL-A580 in advanced solid tumours, run by Hutchmed, now recruiting.","summary":"HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor is a phase 1/2 interventional study registered as NCT07396584 by Hutchmed, with 186 participants planned, started 2026-03-04 and due to reach its primary completion in 2028-12-31. Interventions recorded: HMPL-A580.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07396584","url":"https://clinicaltrials.gov/study/NCT07396584"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07396584","phase":"1/2","setting":"A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A580 in Participants With Advanced or Metastatic Solid Tumors","sponsor":"Hutchmed","started":"2026-03-04","startedType":"actual","enrolled":186,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00412022","kind":"trial","name":"HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer","aka":["HOBOE"],"tldr":"A phase 3 trial of Tamoxifen, Triptorelin, Letrozole and Zoledronic acid in Breast cancer, run by National Cancer Institute, Naples, with a status the registry has not verified recently.","summary":"HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer is a phase 3 interventional study registered as NCT00412022 by National Cancer Institute, Naples, with 1294 participants planned, started 2004-03 and due to reach its primary completion in 2024-11. Interventions recorded: tamoxifen, triptorelin, letrozole, zoledronic acid. Conditions recorded: Breast Cancer.\n\nLinked to the drug Triptorelin because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00412022","url":"https://clinicaltrials.gov/study/NCT00412022"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tamoxifen","triptorelin","letrozole","zoledronic-acid"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00412022","phase":"3","setting":"Phase III Randomized Study of the Effects on Bone Mineral Density of Tamoxifen, Letrozole, and Letrozole + Zoledronic Acid as Adjuvant Treatment of Patients With Early Breast Cancer; VERSION 2 AMENDED Phase 3 Study of Triptorelin and Tamoxifen, Letrozole, or Letrozole + Zoledronic Acid in Adjuvant Treatment of Premenopausal Endocrine Responsive Breast Cancer Patients.","sponsor":"National Cancer Institute, Naples","started":"2004-03","enrolled":1294,"enrolledBasis":"registry","outcomes":[]},{"id":"horizon-breast01","kind":"trial","name":"HORIZON-Breast01","aka":[],"tldr":"A Chinese HER2 ADC cut the risk of progression by nearly 80% versus a pill-plus-chemotherapy standard, matching the scale of Enhertu's results.","summary":"HORIZON-Breast01, trial NCT05424835 sponsored by Jiangsu Hengrui and reported at ESMO 2025 and in Lancet Oncology in 2026, showed that the Chinese HER2 antibody-drug conjugate trastuzumab rezetecan cut the risk of progression by nearly eighty percent compared with pyrotinib plus capecitabine in HER2-positive metastatic breast cancer after trastuzumab and a taxane, matching the scale of trastuzumab deruxtecan's results. It randomised 366 patients in China and met its primary progression-free survival endpoint by blinded review at an interim analysis with a very large effect. OnCo links it to trastuzumab rezetecan and pyrotinib. The effect is comparable in magnitude to DESTINY-Breast03, but there is no head-to-head comparison with trastuzumab deruxtecan, which is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05424835","url":"https://clinicaltrials.gov/study/NCT05424835"}],"tags":[],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","pyrotinib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-horizon-breast01-lancet-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05424835","phase":"3","setting":"HER2+ metastatic breast cancer after trastuzumab and taxane (China): trastuzumab rezetecan (SHR-A1811) vs pyrotinib + capecitabine","sponsor":"Jiangsu Hengrui","result":"PFS 30.6 vs 8.3 months, HR 0.22.","started":"2022-08-04","startedType":"actual","yearReported":2025,"enrolled":381,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Trastuzumab rezetecan","value":30.6},{"name":"Pyrotinib + capecitabine","value":8.3}],"hr":0.22,"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(26)00193-2/abstract"}],"replication":"Comparable in magnitude to DESTINY-Breast03; no head-to-head with T-DXd."},{"id":"nct00003653","kind":"trial","name":"Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Bicalutamide, Buserelin, Flutamide, Goserelin / leuprolide, Leuprolide and Nilutamide in Prostate cancer, run by NCIC Clinical Trials Group, completed.","summary":"Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer is a phase 3 interventional study registered as NCT00003653 by NCIC Clinical Trials Group, with 1386 participants recorded, started 1999-01-05 and reaching its primary completion in 2010-10-04. Interventions recorded: bicalutamide, buserelin, cyproterone acetate, flutamide, goserelin, leuprolide acetate, nilutamide. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Nilutamide because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00003653","url":"https://clinicaltrials.gov/study/NCT00003653"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-bcr"],"sections":[],"technologies":[],"targets":[],"drugs":["bicalutamide","buserelin","flutamide","goserelin","leuprolide","nilutamide"],"companies":["cctg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003653","phase":"3","setting":"A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer","sponsor":"NCIC Clinical Trials Group","started":"1999-01-05","startedType":"actual","enrolled":1386,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00004054","kind":"trial","name":"Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Bicalutamide, Estramustine, Etoposide, Flutamide and Paclitaxel / nab-paclitaxel in Prostate cancer, run by Radiation Therapy Oncology Group, completed.","summary":"Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer is a phase 3 interventional study registered as NCT00004054 by Radiation Therapy Oncology Group, with 397 participants recorded, started 2000-01 and reaching its primary completion in 2010-04. Interventions recorded: bicalutamide, estramustine phosphate sodium, etoposide, flutamide, paclitaxel, Luteinizing hormone releasing hormone [LHRH] agonist, Radiation therapy, warfarin. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Estramustine because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00004054","url":"https://clinicaltrials.gov/study/NCT00004054"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["bicalutamide","estramustine","etoposide","flutamide","paclitaxel"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00004054","phase":"3","setting":"A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer","sponsor":"Radiation Therapy Oncology Group","started":"2000-01","yearReported":2015,"enrolled":397,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (5-year Rate Reported)","primary":true,"unit":"%","arms":[{"name":"Hormones and RT","n":197,"value":84.9,"note":"95% CI 79.9 to 90; Figures from the ClinicalTrials.gov results section (first posted 2015-01-07), not from a publication"},{"name":"Hormones and RT Plus Chemotherapy","n":200,"value":87.2,"note":"95% CI 82.4 to 91.9"}],"hr":1.04,"ci":[0.76,1.43],"p":"0.81","source":"https://clinicaltrials.gov/study/NCT00004054?tab=results"}]},{"id":"nct00055731","kind":"trial","name":"Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse","aka":[],"tldr":"A phase 3 trial of Bicalutamide, Goserelin / leuprolide, Docetaxel, Estramustine and Aspirin in Prostate cancer, run by UNICANCER, completed.","summary":"Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse is a phase 3 interventional study registered as NCT00055731 by UNICANCER, with 413 participants recorded, started 2002-11-14 and reaching its primary completion in 2010-12-21. Interventions recorded: bicalutamide, Goserelin Acetate, docetaxel, Estramustine phosphate sodium, acetylsalicylic acid, conventional surgery, radiation therapy. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Estramustine because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00055731","url":"https://clinicaltrials.gov/study/NCT00055731"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["bicalutamide","goserelin","docetaxel","estramustine","aspirin"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00055731","phase":"3","setting":"Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse","sponsor":"UNICANCER","started":"2002-11-14","startedType":"actual","enrolled":413,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00002633","kind":"trial","name":"Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer","aka":["NCIC CTG PR.3","MRC PR07","Intergroup T94-0110"],"tldr":"A phase 3 trial of Bicalutamide, Buserelin, Flutamide, Goserelin / leuprolide, Leuprolide and Nilutamide in Prostate cancer, run by NCIC Clinical Trials Group, completed.","summary":"Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer is a phase 3 interventional study registered as NCT00002633 by NCIC Clinical Trials Group, with 361 participants recorded, started 1995-02-08 and reaching its primary completion in 2011-09-23. Interventions recorded: bicalutamide, buserelin, flutamide, goserelin, leuprolide acetate, nilutamide, orchiectomy, radiation therapy. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Nilutamide because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00002633","url":"https://clinicaltrials.gov/study/NCT00002633"},{"label":"NCIC CTG PR.3 / MRC PR07 final report (Journal of Clinical Oncology 2015)","url":"https://doi.org/10.1200/JCO.2014.57.7510"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["bicalutamide","buserelin","flutamide","goserelin","leuprolide","nilutamide"],"companies":["cctg"],"institutions":[],"pathways":[],"terms":[],"trials":["spcg-7","eortc-22863"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["The trial, registered as NCT00002633 and known as NCIC Clinical Trials Group PR.3, Medical Research Council PR07 and Intergroup T94-0110, randomised 1,205 men between 1995 and 2005 with T3 to T4 N0 or Nx M0 prostate cancer, or T1 to T2 disease with a PSA above 40 micrograms per litre, or a PSA of 20 to 40 with a Gleason score of 8 to 10. Randomisation was to lifelong androgen deprivation alone or androgen deprivation with radiotherapy of 64 to 69 Gy in 35 to 39 fractions to the prostate and pelvis or to the prostate alone.\n\nAt a median 8 years, 465 men had died, 199 of prostate cancer. Overall survival was significantly better with the addition of radiotherapy (hazard ratio 0.70, 95 percent confidence interval 0.57 to 0.85, p<0.001) and deaths from prostate cancer were significantly reduced (0.46, 0.34 to 0.61, p<0.001). Men on the combination reported more bowel toxicity, but only two of 589 had grade 3 or greater diarrhoea at 24 months after radiotherapy (Journal of Clinical Oncology 2015).","The registry record gives 361 participants, which is the figure recorded on ClinicalTrials.gov; the published intergroup analysis reports 1,205 randomised. The published figure is the one used above."],"nct":"NCT00002633","phase":"3","setting":"Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3-4, N0, M0 Adenocarcinoma of the Prostate","sponsor":"NCIC Clinical Trials Group","result":"Adding radiotherapy to lifelong androgen deprivation in locally advanced prostate cancer improved overall survival (hazard ratio 0.70, 95 percent confidence interval 0.57 to 0.85, p<0.001) and halved deaths from prostate cancer (0.46, 0.34 to 0.61, p<0.001) at a median 8 years.","started":"1995-02-08","startedType":"actual","yearReported":2015,"enrolled":361,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"arms":[{"name":"Androgen deprivation with radiotherapy","n":603},{"name":"Androgen deprivation alone","n":602}],"hr":0.7,"ci":[0.57,0.85],"p":"<0.001","source":"https://doi.org/10.1200/JCO.2014.57.7510"},{"endpoint":"Death from prostate cancer","arms":[{"name":"Androgen deprivation with radiotherapy","n":603},{"name":"Androgen deprivation alone","n":602}],"hr":0.46,"ci":[0.34,0.61],"p":"<0.001","source":"https://doi.org/10.1200/JCO.2014.57.7510"}],"replication":"SPCG-7 found the same in 875 men, halving 10-year prostate cancer mortality from 23.9 to 11.9 percent."},{"id":"horrad","kind":"trial","name":"HORRAD","aka":[],"tldr":"HORRAD found no overall survival benefit from irradiating the prostate in men presenting with bone metastases, though a possible gain in those with few metastases fed into STAMPEDE's later positive finding.","summary":"HORRAD randomised 432 men with newly diagnosed prostate cancer and bone metastases to androgen deprivation therapy with or without external beam radiotherapy to the prostate. Median overall survival was 45 months with radiotherapy and 43 months without (hazard ratio 0.90, not significant); time to PSA progression improved and a subgroup with fewer than five metastases suggested benefit (Boeve and colleagues, European Urology 2019). STAMPEDE arm H later confirmed a survival gain from prostate radiotherapy in low-volume metastatic disease.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01053676","url":"https://clinicaltrials.gov/study/NCT01053676"},{"label":"European Urology 2019","url":"https://doi.org/10.1016/j.eururo.2018.09.008"}],"tags":["radiation-wave4"],"related":[],"cancers":["prostate","metastatic-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["stampede"],"people":[],"bottlenecks":[],"keyPapers":["paper-boeve-eur-urol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01053676","phase":"3","setting":"Newly diagnosed prostate cancer with bone metastases: androgen deprivation with or without radiotherapy to the prostate","sponsor":"Dutch HORRAD study group","result":"Median overall survival 45 vs 43 months (hazard ratio 0.90, not significant).","started":"2010-01","yearReported":2019,"enrolled":432,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"ADT + prostate radiotherapy","value":45},{"name":"ADT alone","value":43}],"hr":0.9,"ci":[0.7,1.14],"p":"0.4","source":"https://doi.org/10.1016/j.eururo.2018.09.008"},{"endpoint":"Time to PSA progression","unit":"months","arms":[{"name":"ADT + prostate radiotherapy","value":15},{"name":"ADT alone","value":12}],"hr":0.78,"ci":[0.63,0.97],"p":"0.02","source":"https://doi.org/10.1016/j.eururo.2018.09.008"}]},{"id":"nct06217042","kind":"trial","name":"HR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial of liposomal irinotecan, cAPOX (capecitabine, oxaliplatin), leucovorin (folinic acid), gemcitabine and other drugs in pancreatic cancer, run by Fudan University, not yet recruiting.","summary":"HR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer is a phase 3, randomised interventional study registered as NCT06217042 by Fudan University, with a registry enrolment figure of 524 participants, started 2024-02-05 and due to reach its primary completion in 2027-03-30. Interventions recorded: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate; gemcitabine; capecitabine. Conditions listed: Pancreatic Cancer. Primary outcome: Disease-free survival (DFS). Pancreatic eligibility wording from the registry: \"Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06217042","url":"https://clinicaltrials.gov/study/NCT06217042"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["liposomal-irinotecan","capox","leucovorin","gemcitabine","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06217042","phase":"3","setting":"HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Gemcitabine in Combination With Capecitabine as Adjuvant Therapy for Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.","sponsor":"Fudan University","started":"2024-02-05","startedType":"estimated","enrolled":524,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06383078","kind":"trial","name":"HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of liposomal irinotecan, cAPOX (capecitabine, oxaliplatin), tegafur, gimeracil and oteracil (S-1), leucovorin (folinic acid) and other drugs in pancreatic cancer, run by The First Affiliated Hospital with Nanjing Medical University, not yet recruiting.","summary":"HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer is a phase 2, randomised interventional study registered as NCT06383078 by The First Affiliated Hospital with Nanjing Medical University, with a registry enrolment figure of 120 participants, started 2024-04-20 and due to reach its primary completion in 2027-03-01. Interventions recorded: HR070803; Oxaliplatin; Tegafur; Folinic acid; 5-Fluorouracil. Conditions listed: Efficacy and Safety. Primary outcome: 1-year Disease-free survival rate. Pancreatic eligibility wording from the registry: \"Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06383078","url":"https://clinicaltrials.gov/study/NCT06383078"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["liposomal-irinotecan","capox","tegafur-gimeracil-oteracil","leucovorin","fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06383078","phase":"2","setting":"HR070803 in Combination With Oxaliplatin Plus Tegafur Versus HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate as Adjuvant Therapy for Pancreatic Cancer: A Multicenter, Multi-cohort, Randomized, Phase II Study","sponsor":"The First Affiliated Hospital with Nanjing Medical University","started":"2024-04-20","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07232875","kind":"trial","name":"HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial of HRS-4642 + AG in pancreatic ductal adenocarcinoma, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic Cancer is a phase 3 interventional study registered as NCT07232875 by Jiangsu HengRui Medicine Co., Ltd., with 588 participants planned, started 2025-11-21 and due to reach its primary completion in 2029-04. Interventions recorded: HRS-4642 + AG and HRS-4642 placebo + AG.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07232875","url":"https://clinicaltrials.gov/study/NCT07232875"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07232875","phase":"3","setting":"a Randomized, Controlled, Double-Blind, Multicenter Phase III Clinical Trial of HRS-4642 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as First-Line Therapy in Patients With Advanced or Metastatic Pancreatic Carcinoma Harboring KRAS G12D Gene Mutation","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-11-21","startedType":"actual","enrolled":588,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07296341","kind":"trial","name":"HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Adebrelimab and Gemcitabine in pancreatic ductal adenocarcinoma, run by Shanghai Hengrui Pharmaceutical Co., Ltd., now recruiting.","summary":"HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors is a phase 1/2 interventional study registered as NCT07296341 by Shanghai Hengrui Pharmaceutical Co., Ltd., with 60 participants planned, started 2026-01-08 and due to reach its primary completion in 2027-10. Interventions recorded: HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine and HRS-4642;nab-paclitaxel; gemcitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07296341","url":"https://clinicaltrials.gov/study/NCT07296341"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["adebrelimab","gemcitabine"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07296341","phase":"1/2","setting":"A Phase IB/II Study To Evaluate the Safety, Tolerability, and Preliminary Efficacy of HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2026-01-08","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06587061","kind":"trial","name":"HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Ruijin Hospital, now recruiting.","summary":"HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer is a phase 2, interventional study registered as NCT06587061 by Ruijin Hospital, with a registry enrolment figure of 30 participants, started 2024-12-03 and due to reach its primary completion in 2027-06. Interventions recorded: HRS-4642+AG. Conditions listed: Pancreatic Cancer. Primary outcome: Adverse events (AEs); Objective Response Rate (ORR). Pancreatic eligibility wording from the registry: \"Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06587061","url":"https://clinicaltrials.gov/study/NCT06587061"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06587061","phase":"2","setting":"An Exploratory Clinical Study of HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer","sponsor":"Ruijin Hospital","started":"2024-12-03","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07131514","kind":"trial","name":"HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of adebrelimab in pancreatic cancer, run by Ruijin Hospital, now recruiting.","summary":"HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer is a phase 2, interventional study registered as NCT07131514 by Ruijin Hospital, with a registry enrolment figure of 30 participants, started 2025-08-25 and due to reach its primary completion in 2027-06. Interventions recorded: HRS-4642+AG +Adebrelimab. Conditions listed: Pancreatic Cancer. Primary outcome: Adverse events (AEs); Objective Response Rate (ORR). Pancreatic eligibility wording from the registry: \"Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07131514","url":"https://clinicaltrials.gov/study/NCT07131514"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07131514","phase":"2","setting":"An Exploratory Clinical Study of HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer","sponsor":"Ruijin Hospital","started":"2025-08-25","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07240766","kind":"trial","name":"HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation","aka":[],"tldr":"A phase 2 trial of nimotuzumab in pancreatic cancer, run by Zhejiang University, now recruiting.","summary":"HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation is a phase 2, interventional study registered as NCT07240766 by Zhejiang University, with a registry enrolment figure of 40 participants, started 2026-02-15 and due to reach its primary completion in 2027-05-15. Interventions recorded: HRS-4642+AG+Nimotuzumab. Conditions listed: Borderline Resectable Pancreatic Adenocarcinoma. Primary outcome: 12-month Event-Free Survival (EFS) rate. Pancreatic eligibility wording from the registry: \"* Histopathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07240766","url":"https://clinicaltrials.gov/study/NCT07240766"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["nimotuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07240766","phase":"2","setting":"Phase II Study of HRS-4642 in Combination With Nimotuzumab and Chemotherapy for Subjects With Borderline Resectable Pancreatic Cancer With KRAS G12D Mutation","sponsor":"Zhejiang University","started":"2026-02-15","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06770452","kind":"trial","name":"HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients","aka":[],"tldr":"A phase 2 trial of nimotuzumab and gemcitabine + nab-paclitaxel in pancreatic cancer, run by Zhejiang University, now recruiting.","summary":"HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients is a phase 2, randomised interventional study registered as NCT06770452 by Zhejiang University, with a registry enrolment figure of 133 participants, started 2025-03-25 and due to reach its primary completion in 2027-02-01. Interventions recorded: HRS-4642; Nimotuzumab; gemcitabine + nab-paclitaxel. Conditions listed: Metastatic Pancreatic Carcinoma. Primary outcome: Objective reponse rate (ORR). Pancreatic eligibility wording from the registry: \"Metastatic pancreatic cancer (from pancreatic ductal epithelium) for Arm A; Locally advanced pancreatic cancer (from pancreatic ductal epithelium) for Arm B; 3\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06770452","url":"https://clinicaltrials.gov/study/NCT06770452"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["nimotuzumab","gemcitabine-nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06770452","phase":"2","setting":"A Single-arm Phase II Study of HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients With KRAS G12D Mutations","sponsor":"Zhejiang University","started":"2025-03-25","startedType":"actual","enrolled":133,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07612007","kind":"trial","name":"HRX215, A First Generation MKK4 Inhibitor Drug, for the Treatment of Patients With Colorectal Liver Metastasis After Undergoing a Portal Vein Embolization","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Mayo Clinic, not yet recruiting.","summary":"HRX215, A First Generation MKK4 Inhibitor Drug, for the Treatment of Patients With Colorectal Liver Metastasis After Undergoing a Portal Vein Embolization is a phase 2, randomised interventional study registered as NCT07612007 by Mayo Clinic, with a registry enrolment figure of 80 participants, started 2026-09-01 and due to reach its primary completion in 2028-08-01. Interventions recorded: Biopsy Procedure; Biospecimen Collection; Computed Tomography; Darizmetinib; Embolization Therapy; Hepatectomy; Magnetic Resonance Imaging; Placebo Administration; Positron Emission Tomography. Conditions listed: Metastatic Colorectal Carcinoma; Metastatic Malignant Neoplasm in the Liver; Resectable Colorectal Carcinoma; Stage IV Colorectal Cancer AJCC v8. Primary outcome: Future liver remnant size (FLR). Colorectal eligibility wording from the registry: \"* REGISTRATION: Individuals with metachronous colorectal carcinoma liver metastases (CRCLM) after resection of the primary OR synchronous CRCLM with planned simultaneous resection of primary and metastatic disease\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07612007","url":"https://clinicaltrials.gov/study/NCT07612007"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07612007","phase":"2","setting":"Phase 2B Study to Determine Efficacy of HRX215, a First Generation MKK4 Inhibitor Drug, in Improving Regeneration of the Remnant Liver After Portal Vein Embolization (PVE) of Colorectal Liver Metastasis (CRLM)","sponsor":"Mayo Clinic","started":"2026-09-01","startedType":"estimated","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06855069","kind":"trial","name":"HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer","aka":[],"tldr":"A phase 3 trial testing HS-20089 in ovarian cancer, now recruiting.","summary":"HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer is a phase 3 interventional study registered as NCT06855069, led by Hansoh BioMedical R&D, and recruiting on the registry. Official title: A Multi-centre, Randomised, Open-label, Controlled, Phase III Clinical Study Evaluating HS-20089 vs. Investigator's Choice of Chemotherapy in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer. Planned enrolment is 468 participants (estimated). The study started in 2025-03-13 and primary completion is expected in 2027-03-07. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06855069","url":"https://clinicaltrials.gov/study/NCT06855069"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["hs-20089"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06855069","phase":"3","setting":"A Multi-center, Randomized, Open-label, Controlled, Phase III Clinical Study Evaluating HS-20089 vs. Investigator's Choice of Chemotherapy in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer","sponsor":"Hansoh BioMedical R&D","started":"2025-03-13","startedType":"actual","enrolled":468,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06014190","kind":"trial","name":"HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer","aka":[],"tldr":"A phase 2 trial of HS-20089 in ovarian cancer and endometrial cancer, run by Hansoh BioMedical R&D Company, now recruiting.","summary":"HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer is a phase 2 interventional study registered as NCT06014190 by Hansoh BioMedical R&D Company, with 460 participants planned, started 2023-12-18 and due to reach its primary completion in 2025-12-31. Interventions recorded: HS-20089. Conditions listed: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06014190","url":"https://clinicaltrials.gov/study/NCT06014190"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","endometrial","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["hs-20089"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06014190","phase":"2","setting":"A Phase 2 Study of HS-20089 for Injection in Patients With Recurrent or Metastatic Ovarian Cancer and Endometrial Cancer","sponsor":"Hansoh BioMedical R&D Company","started":"2023-12-18","startedType":"actual","enrolled":460,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06112704","kind":"trial","name":"HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors","aka":["ARTEMIS-005"],"tldr":"A phase 2 trial of HS-20093 in advanced solid tumours, run by Hansoh BioMedical R&D Company, now recruiting.","summary":"HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors is a phase 2 interventional study registered as NCT06112704 by Hansoh BioMedical R&D Company, with 220 participants planned, started 2024-02-06 and due to reach its primary completion in 2026-07-31. Interventions recorded: HS-20093.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06112704","url":"https://clinicaltrials.gov/study/NCT06112704"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["hs-20093"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06112704","phase":"2","setting":"A Phase 2, Open-label, Multi-center Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors (ARTEMIS-005)","sponsor":"Hansoh BioMedical R&D Company","started":"2024-02-06","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07790510","kind":"trial","name":"HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in BRAF V600-Mutant Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of Cetuximab, CAPOX, FLOT in colorectal cancer, run by Haisco Pharmaceutical Group Co., Ltd., now recruiting.","summary":"HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in BRAF V600-Mutant Metastatic Colorectal Cancer is a phase 1/2 interventional study registered as NCT07790510 by Haisco Pharmaceutical Group Co., Ltd., with 180 participants planned, started 2026-08-12 and due to reach its primary completion in 2029-09-30. Interventions recorded: HSK42360-Na Tablets, Cetuximab (EGFR inhibitor), mFOLFOX6 Regimen (Oxaliplatin/Leucovorin/5-FU), FOLFIRI Regimen (Irinotecan/Leucovorin/5-FU). Conditions listed: Metastatic Colorectal Cancer (CRC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07790510","url":"https://clinicaltrials.gov/study/NCT07790510"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["cetuximab","capox","flot","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07790510","phase":"1/2","setting":"A Phase I/II Study to Evaluate the Safety, Tolerability, and Efficacy of HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in Patients With BRAF V600-Mutant Metastatic Colorectal Cancer","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","started":"2026-08-12","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05944237","kind":"trial","name":"HTL0039732 in Participants With Advanced Solid Tumours","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Cancer Research UK, now recruiting.","summary":"HTL0039732 in Participants With Advanced Solid Tumours is a phase 1/2, interventional study registered as NCT05944237 by Cancer Research UK, with a registry enrolment figure of 150 participants, started 2023-07-13 and due to reach its primary completion in 2027-06. Interventions recorded: HTL0039732 Capsules; HTL0039732 Capsules and atezolizumab infusion. Conditions listed: Neoplasms; Prostatic Neoplasms, Castration-Resistant; Stomach Neoplasms; Esophageal Neoplasms; Head and Neck Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms; Lung Neoplasms; Urinary Bladder Neoplasms; Mesothelioma, Malignant; Uterine Cervical Neoplasms; Kidney Neoplasms; Sarcoma; Pheochromocytomas. Primary outcome: Maximum tolerated dose (MTD; Dose Escalation Phase); RP2D (Dose Escalation Phase); Number of Adverse Events (AEs) Related to HTL0039732 (Dose Escalation and Expansion Phase). Pancreatic eligibility wording from the registry: \"\\- Histologically proven advanced solid tumour where PGE2/EP4 signalling is believed to be more prevalent or significant (such as microsatellite stable colorectal cancer (MSS CRC), gastro-esophageal cancer, head and neck squamous cell carcinoma (HNSCC), mCRPC, pancreatic cancer, lung cancer, bladder\". Sites: United Kingdom. United Kingdom sites listed: 5. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05944237","url":"https://clinicaltrials.gov/study/NCT05944237"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Addenbrooke's Hospital (Cambridge); Velindre Cancer Centre (Cardiff); Clatterbridge Cancer Centre (Liverpool); Guy's Hospital (London); The Christie Hospital (Manchester)."],"nct":"NCT05944237","phase":"1/2","setting":"A Cancer Research UK Phase I/IIa Trial of HTL0039732, Given Orally as Monotherapy and in Combination With Immunotherapy or Other Approved Therapies in Participants With Advanced Solid Tumours","sponsor":"Cancer Research UK","started":"2023-07-13","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05594797","kind":"trial","name":"Human BCMA Targeted T Cells Injection（BCMA CAR-T）for Subjects With R/R MM","aka":[],"tldr":"A phase 2 trial of Human BCMA Targeted T Cells Injection in multiple myeloma, run by Hrain Biotechnology Co., Ltd., now recruiting.","summary":"Human BCMA Targeted T Cells Injection（BCMA CAR-T）for Subjects With R/R MM is a phase 2 interventional study registered as NCT05594797 by Hrain Biotechnology Co., Ltd., with 100 participants planned, started 2022-07-12 and due to reach its primary completion in 2025-07-31. Interventions recorded: Human BCMA Targeted T Cells Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05594797","url":"https://clinicaltrials.gov/study/NCT05594797"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":["bcma"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05594797","phase":"2","setting":"A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection Therapy for Relapsed/Refractory Multiple Myeloma","sponsor":"Hrain Biotechnology Co., Ltd.","started":"2022-07-12","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06708663","kind":"trial","name":"HX009+ IN10018 With or Without Standard Chemotherapy for Advanced Solid Tumours","aka":[],"tldr":"A phase 1/2 trial of IN10018 in melanoma, run by Hangzhou Hanx Biopharmaceuticals, Ltd., now recruiting.","summary":"HX009+ IN10018 With or Without Standard Chemotherapy for Advanced Solid Tumours is a phase 1/2 interventional study registered as NCT06708663 by Hangzhou Hanx Biopharmaceuticals, Ltd., with 124 participants planned, started 2025-01-17 and due to reach its primary completion in 2027-12-31. Interventions recorded: HX009+IN10018. Conditions listed: Biliary Tract Cancer, Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06708663","url":"https://clinicaltrials.gov/study/NCT06708663"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["in10018"],"companies":["hangzhou-hanx-biopharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06708663","phase":"1/2","setting":"Phase IIa Study of HX009+IN10018 in Patients With Advanced Solid Tumours, Including Biliary Tract Malignancies and Malignant Melanoma, Treated With or Without Standard Chemotherapy","sponsor":"Hangzhou Hanx Biopharmaceuticals, Ltd.","started":"2025-01-17","startedType":"actual","enrolled":124,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06649708","kind":"trial","name":"HX044,FIH Study in Patients with Advanced Solid Tumor Malignancies","aka":[],"tldr":"A phase 1/2 trial of HX044 in advanced solid tumours, run by Hanx Biopharmaceuticals (Wuhan) Co., Ltd., now recruiting.","summary":"HX044,FIH Study in Patients with Advanced Solid Tumor Malignancies is a phase 1/2 interventional study registered as NCT06649708 by Hanx Biopharmaceuticals (Wuhan) Co., Ltd., with 100 participants planned, started 2024-12-30 and due to reach its primary completion in 2025-10-31. Interventions recorded: HX044.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06649708","url":"https://clinicaltrials.gov/study/NCT06649708"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hangzhou-hanx-biopharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06649708","phase":"1/2","setting":"A Phase I/IIa, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HX044 in Patients with Advanced Solid Tumor Malignancies","sponsor":"Hanx Biopharmaceuticals (Wuhan) Co., Ltd.","started":"2024-12-30","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06149247","kind":"trial","name":"HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL","aka":[],"tldr":"A phase 2 trial of Synthetic hypericin in Cutaneous T-cell lymphoma and Peripheral T-cell lymphomas, run by Soligenix, completed.","summary":"HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL is a phase 2 interventional study registered as NCT06149247 by Soligenix, with 10 participants recorded, started 2023-12-05 and reaching its primary completion in 2024-05-31. Interventions recorded: Hypericin, Mechlorethamine Topical Gel. Conditions recorded: Cutaneous T-Cell Lymphoma/Mycosis Fungoides.\n\nLinked to the drug Synthetic hypericin because the registry names it among its interventions and Cutaneous T-cell lymphoma and Peripheral T-cell lymphomas among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06149247","url":"https://clinicaltrials.gov/study/NCT06149247"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cutaneous-t-cell-lymphoma","peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["hypericin-sgx301"],"companies":["soligenix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06149247","phase":"2","setting":"Pilot Study of HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL","sponsor":"Soligenix","started":"2023-12-05","startedType":"actual","yearReported":2025,"enrolled":10,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score","primary":true,"unit":"participants","arms":[{"name":"HyBryte (0.25 % Hypericin)","n":5,"value":3,"note":"Figures from the ClinicalTrials.gov results section (first posted 2025-08-20), not from a publication"},{"name":"Valchlor (Mechlorethamine)","n":5,"value":1}],"source":"https://clinicaltrials.gov/study/NCT06149247?tab=results"}]},{"id":"nct04889742","kind":"trial","name":"Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors","aka":["HETERERO"],"tldr":"A phase 2 trial in colorectal cancer, run by Charite University, Berlin, Germany, not yet recruiting.","summary":"Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors is a phase 2, interventional study registered as NCT04889742 by Charite University, Berlin, Germany, with a registry enrolment figure of 110 participants, started 2024-05-10 and due to reach its primary completion in 2026-01. Interventions recorded: loco-regional hyperthermia. Conditions listed: Recurrent Cancer; Prostate Cancer; Cervical Cancer; Anal Cancer; Sarcoma; Rectal Cancer; Neuroendocrine Tumors; Esophageal Cancer; Pancreas Cancer; Squamous Cell Carcinoma. Primary outcome: Local tumor recurrence. Sites: Germany. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04889742","url":"https://clinicaltrials.gov/study/NCT04889742"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04889742","phase":"2","setting":"Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors","sponsor":"Charite University, Berlin, Germany","started":"2024-05-10","startedType":"estimated","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04858009","kind":"trial","name":"Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis","aka":[],"tldr":"A phase 2 trial of cisplatin and nab-paclitaxel in pancreatic cancer, run by Mayo Clinic, now recruiting.","summary":"Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis is a phase 2, interventional study registered as NCT04858009 by Mayo Clinic, with a registry enrolment figure of 40 participants, started 2024-02-15 and due to reach its primary completion in 2029-07. Interventions recorded: Cisplatin; Hyperthermic Intraperitoneal Chemotherapy; Nab-paclitaxel; Computed Tomography; Magnetic Resonance Imaging; Positron Emission Tomography. Conditions listed: Metastatic Pancreatic Carcinoma; Stage IV Pancreatic Cancer AJCC v8; Metastatic Malignant Neoplasm in the Peritoneum. Primary outcome: Overall survival; Progression-free survival. Pancreatic eligibility wording from the registry: \"* Cytologic or histologic proof of adenocarcinoma of the pancreas\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04858009","url":"https://clinicaltrials.gov/study/NCT04858009"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04858009","phase":"2","setting":"A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Pancreatic Cancer and Peritoneal Metastasis","sponsor":"Mayo Clinic","started":"2024-02-15","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"hypo-rt-pc","kind":"trial","name":"HYPO-RT-PC","aka":[],"tldr":"The Scandinavian HYPO-RT-PC trial showed that seven large radiotherapy doses control intermediate- to high-risk prostate cancer as well as 39 conventional ones, with similar late side effects.","summary":"HYPO-RT-PC randomised 1,200 men with intermediate- or high-risk prostate cancer, without hormone therapy, to ultra-hypofractionated radiotherapy (42.7 Gy in seven fractions, three per week) or conventional fractionation (78 Gy in 39). Five-year failure-free survival was 84 percent in both arms, meeting non-inferiority; acute urinary toxicity was higher with the short schedule but late toxicity was similar (Widmark and colleagues, Lancet 2019).","status":"positive","asOf":"2026-09-16","links":[{"label":"ISRCTN45905321","url":"https://www.isrctn.com/ISRCTN45905321"},{"label":"Lancet 2019","url":"https://doi.org/10.1016/S0140-6736(19)31131-6"},{"label":"HYPO-RT-PC 5-year outcomes (Lancet 2019)","url":"https://doi.org/10.1016/S0140-6736(19)31131-6"},{"label":"HYPO-RT-PC patient-reported quality of life (Lancet Oncology 2021)","url":"https://doi.org/10.1016/S1470-2045(20)30581-7"},{"label":"ISRCTN registry ISRCTN45905321","url":"https://www.isrctn.com/ISRCTN45905321"}],"tags":["radiation-wave2"],"related":[],"cancers":["prostate","prostate-intermediate-risk","prostate-high-risk"],"sections":[],"technologies":["hypofractionated-radiotherapy","sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["prostate-radiotherapy-fractionation"],"trials":["pace-b","chhip","profit-trial"],"people":[],"bottlenecks":[],"keyPapers":["paper-widmark-lancet"],"journals":[],"dependsOn":[],"notes":["HYPO-RT-PC recruited men up to 75 years old with intermediate-to-high-risk prostate cancer at 12 centres in Sweden and Denmark between 1 July 2005 and 4 November 2015; 1,054 (89 percent) were intermediate risk and 126 (11 percent) high risk. No androgen deprivation therapy was allowed, which makes it a clean test of fractionation. Median follow-up was 5.0 years. Acute RTOG grade 2 or worse urinary toxicity at the end of radiotherapy was 28 percent with ultra-hypofractionation against 23 percent (p=0.057), and there were no significant differences in grade 2 or worse late urinary or bowel toxicity at 5 years (Lancet 2019).","The patient-reported quality-of-life analysis to 6 years found that seven of ten bowel symptoms deteriorated significantly more at the end of radiotherapy with ultra-hypofractionation (stool frequency, rush to toilet, flatulence, bowel cramp, mucus, blood in stool and limitation in daily activity, all p at most 0.0014), with no clinically relevant differences thereafter. At 6 years there was no difference in overall urinary bother (28 against 33 percent), bowel bother (28 against 33 percent), sexual bother (50 against 60 percent) or global health (37 against 42 percent) (Lancet Oncology 2021)."],"phase":"3","setting":"Intermediate- and high-risk prostate cancer: 42.7 Gy in seven fractions over two and a half weeks versus 78 Gy in 39 fractions","sponsor":"Umea University (Sweden)","result":"5-year failure-free survival 84% in both arms, non-inferior.","yearReported":2019,"enrolled":1200,"enrolledBasis":"randomised","enrolledNote":"1,200 patients were enrolled and 1,180 formed the per-protocol population analysed; the trial is registered as ISRCTN45905321.","outcomes":[{"endpoint":"Failure-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"42.7 Gy in 7 fractions","n":598,"value":84},{"name":"78 Gy in 39 fractions","n":602,"value":84}]},{"endpoint":"Failure-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Ultra-hypofractionation, 42.7 Gy in 7 fractions","n":589,"value":84},{"name":"Conventional fractionation, 78.0 Gy in 39 fractions","n":591,"value":84}],"hr":1.002,"ci":[0.758,1.325],"p":"0.99","source":"https://doi.org/10.1016/S0140-6736(19)31131-6"},{"endpoint":"RTOG grade 2 or worse urinary toxicity at 1 year","unit":"%","arms":[{"name":"Ultra-hypofractionation, 42.7 Gy in 7 fractions","n":528,"value":6},{"name":"Conventional fractionation, 78.0 Gy in 39 fractions","n":529,"value":2}],"p":"0.0037","source":"https://doi.org/10.1016/S0140-6736(19)31131-6"}],"replication":"PACE-B found five-fraction stereotactic body radiotherapy non-inferior in 874 men with a longer median follow-up of 74 months."},{"id":"nct06435260","kind":"trial","name":"Hypofractionated Radiotherapy +Chemotherapy+ Camrelizumab as Neoadjuvant Therapy for Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of camrelizumab in pancreatic cancer, run by Hebei Medical University Fourth Hospital, now recruiting.","summary":"Hypofractionated Radiotherapy +Chemotherapy+ Camrelizumab as Neoadjuvant Therapy for Pancreatic Cancer is a phase 2, interventional study registered as NCT06435260 by Hebei Medical University Fourth Hospital, with a registry enrolment figure of 30 participants, started 2024-08-01 and due to reach its primary completion in 2025-06-01. Interventions recorded: Camrelizumab+chemotherapy; hypofractionated radiotherapy. Conditions listed: Pancreatic Cancer. Primary outcome: a.R0-resection rate. Pancreatic eligibility wording from the registry: \"Tumor was located in the pancreas;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06435260","url":"https://clinicaltrials.gov/study/NCT06435260"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac","locally-advanced-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["camrelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06435260","phase":"2","setting":"To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Borderline Resectable/Locally Advanced Pancreatic Cancer","sponsor":"Hebei Medical University Fourth Hospital","started":"2024-08-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06635980","kind":"trial","name":"Hypofractionated Radiotherapy Before or After Breast Surgery for Treatment of Patients With Non-Metastatic Breast Cancer","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Mayo Clinic, now recruiting.","summary":"Hypofractionated Radiotherapy Before or After Breast Surgery for Treatment of Patients With Non-Metastatic Breast Cancer is a phase 2, randomised interventional study registered as NCT06635980 by Mayo Clinic, with a registry enrolment figure of 120 participants, started 2025-05-14 and due to reach its primary completion in 2031-10-21. Interventions recorded: Biopsy of Breast; Biospecimen Collection; Breast Surgery; Chemotherapy; Computed Tomography; Contrast Enhanced Digital Mammography; Hypofractionated Radiation Therapy; Magnetic Resonance Imaging; Positron Emission Tomography; Survey Administration; Tissue Collection; Ultrasound Imaging. Conditions listed: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Breast Carcinoma; Triple-Negative Breast Carcinoma. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06635980","url":"https://clinicaltrials.gov/study/NCT06635980"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06635980","phase":"2","setting":"A Randomized Phase II Trial of Hypofractionated Radiotherapy for Non-Metastatic Breast Cancer Before or After Breast Surgery for Different Breast Cancer Risk Groups","sponsor":"Mayo Clinic","started":"2025-05-14","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07183865","kind":"trial","name":"Hypofractionated Radiotherapy Combined With NALIRIF, PD-1 Antibody in Locally Recurrent Rectal Cancer(NOVELTY-R)","aka":["NOVELTY-R"],"tldr":"A phase 2 trial of fluorouracil (5-FU), fOLFOX (5-FU, leucovorin, oxaliplatin) and bevacizumab (glioblastoma use) in colorectal cancer, run by Fudan University, now recruiting.","summary":"Hypofractionated Radiotherapy Combined With NALIRIF, PD-1 Antibody in Locally Recurrent Rectal Cancer(NOVELTY-R) is a phase 2, interventional study registered as NCT07183865 by Fudan University, with a registry enrolment figure of 44 participants, started 2025-03-09 and due to reach its primary completion in 2030-03-09. Interventions recorded: radiotherapy; Irinotecan Hydrochloride Liposome; 5-FU; Leucovorin; SG001; C225; Bevacizumab. Conditions listed: Locally Recurrent Rectal Cancer. Primary outcome: Local objective response rate. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07183865","url":"https://clinicaltrials.gov/study/NCT07183865"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["fluorouracil","folfox","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07183865","phase":"2","setting":"Hypofractionated Radiotherapy Combined With Irinotecan Hydrochloride Liposome, 5-FU, Leucovorin, PD-1 Antibody and Target Therapy in Locally Recurrent Rectal Cancer(NOVELTY-R)","sponsor":"Fudan University","started":"2025-03-09","startedType":"actual","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06928584","kind":"trial","name":"Hypofractionated Radiotherapy Plus Immunotherapy Versus Conventional Radiotherapy in Locally Recurrent Rectal Cancer","aka":["TORCH-R2"],"tldr":"A phase 2 trial of capecitabine, fluorouracil (5-FU), leucovorin (folinic acid), fOLFOX (5-FU, leucovorin, oxaliplatin) and other drugs in colorectal cancer, run by Fudan University, now recruiting.","summary":"Hypofractionated Radiotherapy Plus Immunotherapy Versus Conventional Radiotherapy in Locally Recurrent Rectal Cancer is a phase 2, randomised interventional study registered as NCT06928584 by Fudan University, with a registry enrolment figure of 221 participants, started 2025-03-10 and due to reach its primary completion in 2030-03-10. Interventions recorded: Conventional Radiotherapy; Capecitabine; 5-fluorouracil; folinic acid; Oxaliplatin; Irinotecan; Cetuximab; Bevacizumab; Hypofractionated radiotherapy; PD-1 antibody. Conditions listed: Locally Recurrent Rectal Cancer. Primary outcome: Progression-Free Survival. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06928584","url":"https://clinicaltrials.gov/study/NCT06928584"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","monoclonal-antibody","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["capecitabine","fluorouracil","leucovorin","folfox","folfiri","cetuximab","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06928584","phase":"2","setting":"Multicenter, Randomized, Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Plus Immunotherapy and First-line Therapy Versus Conventional Radiotherapy Plus First-line Therapy in pMMR Locally Recurrent Rectal Cancer (TORCH-R2)","sponsor":"Fudan University","started":"2025-03-10","startedType":"actual","enrolled":221,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07052669","kind":"trial","name":"Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Sun Yat-sen University, now recruiting.","summary":"Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC is a phase 3, randomised interventional study registered as NCT07052669 by Sun Yat-sen University, with a registry enrolment figure of 311 participants, started 2025-07-01 and due to reach its primary completion in 2029-06-30. Interventions recorded: Hypofractionated Radiation Therapy; Conventionally Fractionated Radiation Therapy; Concurrent Chemotherapy; concurrent chemotherapy; Consolidative immunotherapy. Conditions listed: Locally Advanced Non-Small Cell Lung Cancer. Primary outcome: Median Progression-Free Survival. Lung eligibility wording from the registry: \"* Diagnosis: Patients must have locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC), with histological or cytological confirmation of the diagnosis\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07052669","url":"https://clinicaltrials.gov/study/NCT07052669"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07052669","phase":"3","setting":"Hypofractionated Chemoradiotherapy Followed by Consolidative Immunotherapy Versus Conventional Fractionated Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: A Randomized, Phase III Controlled Study","sponsor":"Sun Yat-sen University","started":"2025-07-01","startedType":"actual","enrolled":311,"enrolledBasis":"registry","outcomes":[]},{"id":"i-predict","kind":"trial","name":"I-PREDICT","aka":["I-PREDICT study","Investigation of Profile-Related Evidence Determining Individualized Cancer Therapy"],"tldr":"I-PREDICT flipped the basket idea: instead of one drug for one mutation, a tumour board built a personal combination for each patient covering as many of their tumour's changes as possible. People whose treatment matched more of their alterations lived longer without progression.","summary":"I-PREDICT was run from the UC San Diego Moores Cancer Center by Razelle Kurzrock and Jason Sicklick with a partner site at Avera Cancer Institute, opening in 2015. Patients with lethal, treatment-refractory cancers had tissue sequencing, circulating tumour DNA testing, PD-L1 and tumour mutational burden measured; a molecular tumour board then proposed a regimen, most often a combination of targeted drugs, immunotherapy and, where needed, chemotherapy, aimed at the largest possible share of each tumour's alterations. The study measured a matching score, the fraction of the tumour's characterised alterations addressed by the regimen.\n\nThe main report, in Nature Medicine in 2019, found that customised combinations were feasible in about half of the profiled patients, that toxicity was manageable with dose adjustment, and that patients with a matching score above 50 percent had higher disease control and longer progression-free and overall survival than those with lower scores. That association between degree of matching and outcome, rather than any single drug's result, was the study's contribution.\n\nI-PREDICT influenced how molecular tumour boards think, shifting from one actionable alteration to the whole profile, and prompted follow-on studies of the same approach in newly diagnosed lethal cancers. Its limits are those of any single-arm study: patients with more alterations covered may also have had different biology, and only a randomised trial such as CUPISCO or ROME can show that matching itself causes the benefit.","status":"completed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02534675","url":"https://clinicaltrials.gov/study/NCT02534675"},{"label":"Sicklick et al., Nature Medicine 2019: molecular profiling of cancer patients enables personalized combination therapy, the I-PREDICT study","url":"https://doi.org/10.1038/s41591-019-0407-5"}],"tags":[],"related":[],"cancers":["rare-cancers"],"sections":[],"technologies":["cgp","liquid-biopsy","variant-knowledgebases"],"targets":[],"drugs":[],"companies":["foundation-medicine"],"institutions":["ucsd-moores"],"pathways":[],"terms":["master-protocol","basket-umbrella-platform","tmb","ctdna"],"trials":[],"people":["razelle-kurzrock"],"bottlenecks":["b-trial-design"],"keyPapers":["paper-sicklick-nat-med"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02534675","phase":"2","setting":"Treatment-refractory advanced solid tumours: tissue and blood genomic profiling reviewed by a molecular tumour board to build an individualised, usually combination, regimen for each patient, with outcomes analysed by how closely the regimen matched the tumour's alterations","sponsor":"University of California, San Diego","result":"Individualised combinations were feasible; a matching score above 50 percent was associated with better disease control and longer progression-free and overall survival.","started":"2015-02","yearReported":2019,"enrolledBasis":"registry","outcomes":[{"endpoint":"Consented patients who received molecularly matched personalised treatment","primary":true,"unit":"%","arms":[{"name":"Consented patients","value":49}],"source":"https://doi.org/10.1038/s41591-019-0407-5"},{"endpoint":"Disease control (stable disease 6 months or longer, or response) by matching score","unit":"%","arms":[{"name":"Matching score above 50%","n":28,"value":50},{"name":"Matching score 50% or below","n":55,"value":22.4}],"p":"0.028","source":"https://doi.org/10.1038/s41591-019-0407-5"},{"endpoint":"Progression-free survival by matching score","unit":"months","arms":[{"name":"Matching score above 50%","n":28,"value":6.5,"note":"Multivariable hazard ratio 0.34 (95% CI 0.19-0.62), p = 0.0004, favouring the high matching score group as reported"},{"name":"Matching score 50% or below","n":55,"value":3.1}],"hr":0.34,"ci":[0.19,0.62],"p":"0.001","source":"https://doi.org/10.1038/s41591-019-0407-5"}]},{"id":"i-spy-1","kind":"trial","name":"I-SPY 1 (CALGB 150007/150012, ACRIN 6657)","aka":["I-SPY 1 TRIAL","ISPY1"],"tldr":"I-SPY 1 followed women having chemotherapy before breast surgery with repeated MRI scans and biopsies, and showed that a tumour vanishing completely (a pathological complete response) predicted long-term survival, especially in the aggressive subtypes.","summary":"I-SPY 1 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis) ran from 2002 to 2006 across nine United States centres, led by Laura Esserman at UCSF with the Cancer and Leukemia Group B and the American College of Radiology Imaging Network. Women with tumours of three centimetres or more received standard anthracycline and taxane chemotherapy before surgery while the study collected MRI scans, core biopsies and blood at set points.\n\nIts findings set the rules for everything that followed: a pathological complete response, no invasive cancer left in the breast and nodes at surgery, predicted recurrence-free survival, and the prediction was strongest in triple-negative and HER2-positive disease and in tumours the MammaPrint test called high risk. Change in tumour volume on MRI after the first cycles also predicted response, which made early imaging a way to tell quickly whether a drug was working.\n\nThe trial built the biomarker-defined subtypes, the imaging protocol and the multi-centre infrastructure that I-SPY 2 turned into a permanent platform.","status":"completed","asOf":"2026-09-17","links":[{"label":"I-SPY Trials: I-SPY 1","url":"https://www.ispytrials.org/i-spy-platform/i-spy1"},{"label":"Esserman et al., Journal of Clinical Oncology 2012: pathologic complete response predicts recurrence-free survival more effectively by cancer subset (I-SPY 1)","url":"https://ascopubs.org/doi/10.1200/JCO.2011.39.2779"}],"tags":[],"related":[],"cancers":["breast-cancer","tnbc","breast-her2-positive"],"sections":[],"technologies":["mri","gene-expression-prognostic-assays"],"targets":[],"drugs":["paclitaxel"],"companies":["alliance-oncology","ecog-acrin"],"institutions":["ucsf"],"pathways":[],"terms":["pcr","neoadjuvant-adjuvant","master-protocol"],"trials":[],"people":["laura-esserman"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"observational","setting":"Stage 2 and 3 breast cancer treated with chemotherapy before surgery: serial MRI and biopsies to learn which early signals predict outcome","sponsor":"CALGB and ACRIN (NCI), led from UCSF","result":"Pathological complete response and early MRI volume change predicted recurrence-free survival, most strongly in triple-negative, HER2-positive and MammaPrint high-risk tumours.","yearReported":2012,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free survival, pathological complete response versus no pCR (172 patients treated without trastuzumab)","primary":true,"arms":[{"name":"Pathological complete response"},{"name":"No pathological complete response"}],"hr":0.29,"ci":[0.07,0.82],"source":"https://doi.org/10.1200/JCO.2011.39.2779"},{"endpoint":"Pathological complete response by receptor subset (190 patients treated without trastuzumab)","unit":"%","arms":[{"name":"HR-negative / HER2-positive","value":45},{"name":"HR-positive / HER2-negative","value":9}],"source":"https://doi.org/10.1200/JCO.2011.39.2779"}]},{"id":"i-spy-2","kind":"trial","name":"I-SPY 2","aka":["I-SPY 2 TRIAL","ISPY2","I-SPY2"],"tldr":"I-SPY 2 is a permanent, adaptive trial that tests new breast cancer drugs before surgery, steering each drug towards the tumour subtypes where it is working and graduating the winners in two years instead of ten. Several of its graduates became approved treatments.","summary":"I-SPY 2 opened in 2010 as a Bayesian adaptive platform trial, sponsored by the non-profit Quantum Leap Healthcare Collaborative and led by Laura Esserman at UCSF with Don Berry as its statistician. Women with stage 2 or 3 breast cancer at high risk of recurrence (by hormone receptor, HER2 and MammaPrint status) receive standard paclitaxel then anthracycline chemotherapy, with or without an experimental drug, before surgery. The endpoint is pathological complete response, read within months rather than the years a survival endpoint takes. Randomisation is adaptive: as each arm's results accumulate within ten biomarker signatures, new patients are more likely to be assigned to the arm doing best for their subtype.\n\nA drug graduates when the model predicts at least an 85 percent chance of success in a 300-patient phase 3 trial in a given signature; it is dropped for futility when that chance falls below 10 percent. Several arms run at once against a shared control, so each new drug needs far fewer patients than a stand-alone trial.\n\nGraduates and what became of them: veliparib with carboplatin (triple-negative disease, published in the New England Journal of Medicine in 2016, which led to the BrighTNess phase 3 and confirmed the value of carboplatin); neratinib (HER2-positive, hormone receptor-negative disease, NEJM 2016); pembrolizumab (HER2-negative disease, reported at ASCO in 2017), which fed into KEYNOTE-522 and the approval of pembrolizumab for early triple-negative breast cancer; the AKT inhibitor MK-2206; trastuzumab emtansine with pertuzumab (HER2-positive disease, replacing paclitaxel and trastuzumab); durvalumab with olaparib (HER2-negative disease); and the PD-1 and LAG-3 antibody pair cemiplimab and fianlimab (HER2-negative disease, 2022). Other arms, including ganitumab, trebananib, ganetespib and talazoparib with irinotecan, did not graduate, which is also the point: the platform retires drugs early and cheaply.\n\nMore than two thousand women have taken part. The trial has also shown that long-term outcomes track pathological complete response across every subtype and treatment, that response-predictive subtypes defined by immune, DNA repair and hormone signatures sort patients better than receptor status alone, and that MRI plus biopsy during treatment can identify women who are responding early. Those findings became I-SPY 2.2, which changes treatment during the trial according to early response.","status":"active","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01042379","url":"https://clinicaltrials.gov/study/NCT01042379"},{"label":"I-SPY Trials: the I-SPY 2 platform","url":"https://www.ispytrials.org/i-spy-platform/i-spy2"},{"label":"Rugo et al., NEJM 2016: adaptive randomization of veliparib-carboplatin treatment in breast cancer","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1513749"},{"label":"Park et al., NEJM 2016: adaptive randomization of neratinib in early breast cancer","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1513750"},{"label":"Nanda et al., JAMA Oncology 2020: pembrolizumab plus standard neoadjuvant therapy in the I-SPY2 trial","url":"https://jamanetwork.com/journals/jamaoncology/fullarticle/2760405"}],"tags":[],"related":[],"cancers":["breast-cancer","tnbc","breast-her2-positive","breast-hr-positive"],"sections":[],"technologies":["mri","gene-expression-prognostic-assays","checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["paclitaxel","carboplatin","neratinib","pembrolizumab","trastuzumab-emtansine","pertuzumab","durvalumab","olaparib","cemiplimab","fianlimab"],"companies":["quantum-leap-healthcare-collaborative"],"institutions":["ucsf"],"pathways":[],"terms":["pcr","seamless-adaptive","neoadjuvant-adjuvant","master-protocol"],"trials":[],"people":["laura-esserman"],"bottlenecks":[],"keyPapers":["paper-magbanua-ispy2-ctdna-neoadjuvant-ann-oncol-2021","paper-i-spy-2-jama-oncol-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01042379","phase":"platform","setting":"Newly diagnosed stage 2 and 3 breast cancer at high risk of recurrence: new drugs added to standard chemotherapy before surgery, randomised adaptively within biomarker subtypes, with pathological complete response as the endpoint","sponsor":"Quantum Leap Healthcare Collaborative","result":"Multiple graduations (veliparib-carboplatin, neratinib, pembrolizumab, MK-2206, T-DM1 plus pertuzumab, durvalumab plus olaparib, cemiplimab plus fianlimab); pembrolizumab's graduation preceded its approval in early triple-negative breast cancer.","started":"2010-03-01","startedType":"actual","yearReported":2016,"enrolledBasis":"registry","outcomes":[]},{"id":"i-spy-2-2","kind":"trial","name":"I-SPY 2.2","aka":["I-SPY2.2","ISPY 2.2"],"tldr":"I-SPY 2.2 takes the next step: instead of adding a new drug to the same chemotherapy for everyone, it assigns treatment by a tumour's predicted response type, checks with scans and biopsies whether the tumour is disappearing, and lets women who respond early skip further chemotherapy.","summary":"I-SPY 2.2 began in 2022 under the same registration as I-SPY 2. It replaces the fixed backbone with three blocks. Block A gives an experimental treatment matched to the tumour's response-predictive subtype (defined by hormone receptor, HER2, an immune signature and a DNA repair deficiency signature). Women whose MRI and biopsy show the tumour has gone go straight to surgery; the rest move to block B, standard chemotherapy or a subtype-specific standard, and if still not responding to block C, the best current treatment for that subtype. The design is a sequential multiple assignment randomised trial, so each woman's path is set by her own early response.\n\nThe aim is to raise the pathological complete response rate while lowering the amount of chemotherapy given, and to find, for each subtype, the treatment that works alone. Early results reported from 2024 have described complete response rates by block for the first experimental agents and the share of women who could avoid the chemotherapy blocks altogether.","status":"recruiting","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01042379","url":"https://clinicaltrials.gov/study/NCT01042379"},{"label":"I-SPY Trials: I-SPY 2.2","url":"https://www.ispytrials.org/i-spy-platform/i-spy2-2"}],"tags":[],"related":[],"cancers":["breast-cancer","tnbc","breast-her2-positive","breast-hr-positive"],"sections":[],"technologies":["mri","checkpoint-inhibitor"],"targets":[],"drugs":["paclitaxel","pembrolizumab","trastuzumab-duocarmazine"],"companies":["quantum-leap-healthcare-collaborative"],"institutions":["ucsf"],"pathways":[],"terms":["pcr","seamless-adaptive","neoadjuvant-adjuvant","master-protocol"],"trials":[],"people":["laura-esserman"],"bottlenecks":[],"keyPapers":["paper-i-spy-2-jama-oncol-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01042379","phase":"platform","setting":"High-risk early breast cancer: a sequential multiple assignment randomised design that starts with a new agent chosen by response-predictive subtype and escalates or de-escalates treatment according to MRI and biopsy response","sponsor":"Quantum Leap Healthcare Collaborative","result":"Ongoing; the first block results and de-escalation rates were reported from 2024.","started":"2010-03-01","startedType":"actual","yearReported":2024,"enrolledBasis":"registry","outcomes":[]},{"id":"ialt","kind":"trial","name":"IALT (International Adjuvant Lung Cancer Trial)","aka":["International Adjuvant Lung Cancer Trial"],"tldr":"The first large trial to show that chemotherapy after lung cancer surgery helps people live longer, though the gain is a few percent rather than a transformation.","summary":"IALT randomised 1,867 patients with completely resected non-small-cell lung cancer to three or four cycles of cisplatin-based chemotherapy or to observation. Each centre chose the partner drug and its own postoperative radiotherapy policy, so the trial is a test of the strategy rather than of a regimen: etoposide was used in 56.5 percent, vinorelbine in 26.8 percent, vinblastine in 11.0 percent and vindesine in 5.8 percent. Pathological stage was I in 36.5 percent, II in 24.2 percent and III in 39.3 percent.\n\nAt a median 56 months, five-year survival was 44.5 percent with chemotherapy against 40.4 percent with observation (469 against 504 deaths, hazard ratio for death 0.86, 95 percent confidence interval 0.76 to 0.98). Three-quarters of the chemotherapy arm received at least 240 mg/m2 of cisplatin.\n\nIALT is the trial that made adjuvant chemotherapy the standard, and its size is the reason the four-to-five percent absolute benefit is believed. Later follow-up weakened the survival difference, which is part of why the LACE pooled analysis was done.","status":"positive","asOf":"2026-09-25","links":[{"label":"IALT (New England Journal of Medicine 2004)","url":"https://doi.org/10.1056/NEJMoa031644"}],"tags":[],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin","etoposide","vinorelbine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["jbr-10","anita","lace-pooled-analysis"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Completely resected non-small-cell lung cancer, any stage I to III: three or four cycles of cisplatin-based chemotherapy versus observation, with overall survival as the primary endpoint","sponsor":"Institut Gustave Roussy and the IALT Collaborative Group","result":"Five-year survival 44.5 against 40.4 percent (hazard ratio for death 0.86).","yearReported":2004,"enrolled":1867,"enrolledBasis":"randomised","enrolledNote":"1,867 patients were randomised; the trial predates ClinicalTrials.gov registration, so there is no registry figure.","outcomes":[{"endpoint":"Overall survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Cisplatin-based chemotherapy","n":932,"value":44.5},{"name":"Observation","n":935,"value":40.4}],"hr":0.86,"ci":[0.76,0.98],"source":"https://doi.org/10.1056/NEJMoa031644"}],"replication":"JBR.10 and ANITA reproduced the benefit with cisplatin and vinorelbine; the LACE pooled analysis of 4,584 patients from the five largest trials confirmed it."},{"id":"iarc-india-hpv-dose-study","kind":"trial","name":"IARC India HPV vaccine dose study (one, two or three doses)","aka":[],"tldr":"When an Indian vaccine trial was halted midway, thousands of girls had had only one shot; following them for ten years showed one dose protected as well as three, changing the world's vaccination policy.","summary":"The study began as a randomised comparison of two versus three doses of quadrivalent HPV vaccine at nine Indian centres. Recruitment was suspended in 2010 by the government, leaving by-default cohorts of girls who had received one dose (4,949), two doses (4,980) or three doses (4,348). At a median follow-up of 9.0 years, vaccine efficacy against persistent HPV 16/18 infection was 95.4% (95% CI 85.0-99.9) after one dose, 93.1% (77.3-99.8) after two and 93.3% (77.5-99.7) after three, and one-dose antibody levels, though lower, were stable. With the KEN SHE randomised trial in Kenya, these results led WHO in 2022 to endorse one- or two-dose schedules, roughly halving the cost of protecting a girl.","status":"positive","asOf":"2026-09-10","links":[{"label":"Basu et al., Lancet Oncology 2021","url":"https://doi.org/10.1016/S1470-2045(21)00453-8"},{"label":"Sankaranarayanan et al., Lancet Oncology 2016","url":"https://doi.org/10.1016/S1470-2045(15)00414-3"}],"tags":[],"related":["idea-single-dose-hpv-self-sampling-elimination"],"cancers":["cervical"],"sections":[],"technologies":["hpv-vaccine"],"targets":[],"drugs":["gardasil-9","cervavac"],"companies":[],"institutions":["iarc","cancer-institute-adyar","tata-memorial"],"pathways":[],"terms":[],"trials":["ken-she"],"people":["basu-partha","sankaranarayanan-rengaswamy"],"bottlenecks":["b-prevention-adoption","b-global-access","b-dose-optimisation"],"keyPapers":["paper-basu-single-dose-hpv-lancet-oncol-2021","paper-sankaranarayanan-lancet-oncol"],"journals":[],"dependsOn":[],"notes":[],"phase":"observational","setting":"Girls aged 10-18 in India randomised to two or three doses of quadrivalent HPV vaccine; after a 2010 suspension of recruitment, cohorts who had received one, two or three doses were followed for a decade","sponsor":"IARC with nine Indian centres","result":"Efficacy against persistent HPV 16/18 infection: 95.4% (1 dose), 93.1% (2 doses), 93.3% (3 doses) at 10 years.","yearReported":2021,"enrolled":17729,"enrolledBasis":"registry","outcomes":[{"endpoint":"Vaccine efficacy against persistent HPV 16/18 infection","primary":true,"unit":"%","arms":[{"name":"One dose","n":4949,"value":95.4,"note":"95% CI 85.0-99.9"},{"name":"Two doses","n":4980,"value":93.1,"note":"95% CI 77.3-99.8"},{"name":"Three doses","n":4348,"value":93.3,"note":"95% CI 77.5-99.7"}],"source":"https://doi.org/10.1016/S1470-2045(21)00453-8"}],"replication":"KEN SHE (Kenya, randomised) showed 97.5% single-dose efficacy against persistent HPV 16/18 infection; WHO endorsed one- or two-dose schedules in 2022."},{"id":"nct00326820","kind":"trial","name":"Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer","aka":[],"tldr":"A phase 3 trial of Ibandronic acid and Zoledronic acid in Breast cancer and Metastatic cancer, run by Wales Cancer Trials Unit, with a status the registry has not verified recently.","summary":"Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer is a phase 3 interventional study registered as NCT00326820 by Wales Cancer Trials Unit, with 1404 participants planned, started 2006-01 and due to reach its primary completion in 2012-12. Interventions recorded: ibandronate sodium, zoledronic acid, Zolendronic Acid. Conditions recorded: Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer.\n\nLinked to the drug Ibandronic acid because the registry names it among its interventions and Breast cancer and Metastatic cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00326820","url":"https://clinicaltrials.gov/study/NCT00326820"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer","metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ibandronic-acid","zoledronic-acid"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00326820","phase":"3","setting":"Zoledronate Versus Ibandronate Comparative Evaluation: A Randomized Phase III, Open-Label, Multicenter, Parallel Group Clinical Trial to Evaluate and Compare the Efficacy, Safety Profile and Tolerability of Oral Ibandronate Versus Intravenous Zoledronate in the Treatment of Breast Cancer Patients With Bone Metastases","sponsor":"Wales Cancer Trials Unit","started":"2006-01","enrolled":1404,"enrolledBasis":"registry","outcomes":[]},{"id":"ibcsg-23-01","kind":"trial","name":"IBCSG 23-01","aka":["International Breast Cancer Study Group 23-01","IBCSG 23-01 micrometastasis trial"],"tldr":"A deposit of cancer smaller than two millimetres in a lymph node is not a reason to clear the armpit. Ten years later the women who had nothing further done were doing slightly better, and had a quarter of the arm swelling.","summary":"IBCSG 23-01 recruited from 27 hospitals in nine countries between 2001 and 2010. Eligible women had a breast cancer of 5 cm or less and one or more sentinel nodes containing a micrometastasis of 2 mm or smaller without extracapsular extension, and were randomised before surgery to axillary clearance or none. 934 were randomised and three were later found ineligible.\n\nAt a median follow-up of 9.7 years, ten-year disease-free survival was 76.8 percent without clearance and 74.9 percent with it (hazard ratio 0.85, 95 percent confidence interval 0.65 to 1.11, log-rank p=0.24, non-inferiority p=0.0024). The morbidity difference is the reason to act on it: lymphoedema of any grade occurred in 16 of 453 patients (4 percent) without clearance and 60 of 447 (13 percent) with it, sensory neuropathy in 13 against 19 percent, and motor neuropathy in 3 against 9 percent.\n\nThe ten-year analysis was not pre-specified in the protocol and was not adjusted for repeated testing, which the authors say plainly. Read with Z0011, it is the reason NICE NG101 recommendation 1.4.14 says not to offer further axillary treatment for micrometastases at all.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00072293","url":"https://clinicaltrials.gov/study/NCT00072293"},{"label":"IBCSG 23-01 ten-year follow-up (Lancet Oncology 2018)","url":"https://doi.org/10.1016/S1470-2045(18)30380-2"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["sentinel-node"],"targets":[],"drugs":[],"companies":["etop-ibcsg"],"institutions":[],"pathways":[],"terms":["sentinel-lymph-node-biopsy","lymphadenectomy","breast-cancer-related-lymphoedema","axillary-surgery-de-escalation"],"trials":["acosog-z0011","senomac"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00072293","phase":"3","setting":"Breast cancer 5 cm or smaller with one or more sentinel node micrometastases of 2 mm or less and no extracapsular extension, after mastectomy or breast-conserving surgery: axillary clearance against no axillary clearance, with disease-free survival as the primary endpoint and a non-inferiority margin of 1.25","sponsor":"International Breast Cancer Study Group","result":"Ten-year disease-free survival 76.8 percent without axillary clearance against 74.9 percent with it (hazard ratio 0.85); lymphoedema 4 against 13 percent.","started":"2001-12","yearReported":2018,"enrolled":931,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 10 years","primary":true,"unit":"%","arms":[{"name":"No axillary dissection","n":469,"value":76.8,"note":"95 percent confidence interval 72.5 to 81.0"},{"name":"Axillary dissection","n":465,"value":74.9,"note":"95 percent confidence interval 70.5 to 79.3"}],"hr":0.85,"ci":[0.65,1.11],"p":"0.24 log-rank, 0.0024 for non-inferiority","source":"https://doi.org/10.1016/S1470-2045(18)30380-2"},{"endpoint":"Lymphoedema of any grade","unit":"%","arms":[{"name":"No axillary dissection","n":453,"value":4},{"name":"Axillary dissection","n":447,"value":13}],"source":"https://doi.org/10.1016/S1470-2045(18)30380-2"}],"replication":"The ten-year Z0011 analysis reached the same conclusion for one or two positive sentinel nodes including macrometastases."},{"id":"nct06974812","kind":"trial","name":"IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of IBI3014 in advanced solid tumours, run by Innovent Biologics (Suzhou) Co. Ltd., now recruiting.","summary":"IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06974812 by Innovent Biologics (Suzhou) Co. Ltd., with 250 participants planned, started 2025-04-18 and due to reach its primary completion in 2026-06-30. Interventions recorded: IBI3014.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06974812","url":"https://clinicaltrials.gov/study/NCT06974812"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06974812","phase":"1/2","setting":"A Phase 1/2 Study of IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","started":"2025-04-18","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07415525","kind":"trial","name":"IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Borderline Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of IBI343 in pancreatic cancer, run by Zhejiang University, not yet recruiting.","summary":"IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Borderline Resectable Pancreatic Cancer is a phase 2, interventional study registered as NCT07415525 by Zhejiang University, with a registry enrolment figure of 40 participants, started 2026-02-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: IBI343. Conditions listed: Pancreatic Cancer; Borderline Resectable Pancreatic Adenocarcinoma. Primary outcome: 12-month Event-Free Survival (EFS) rate. Pancreatic eligibility wording from the registry: \"* (2)Histopathologically confirmed pancreatic adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07415525","url":"https://clinicaltrials.gov/study/NCT07415525"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["ibi343"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07415525","phase":"2","setting":"A Phase II Clinical Study Evaluating the Safety and Efficacy of IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Subjects With Borderline Resectable Pancreatic Cancer","sponsor":"Zhejiang University","started":"2026-02-01","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06770439","kind":"trial","name":"IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of IBI343, gemcitabine and nab-paclitaxel in pancreatic cancer, run by Zhejiang University, now recruiting.","summary":"IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer is a phase 2, randomised interventional study registered as NCT06770439 by Zhejiang University, with a registry enrolment figure of 64 participants, started 2025-04-18 and due to reach its primary completion in 2027-01. Interventions recorded: IBI343; Gemcitabine+Albumin-bound paclitaxel. Conditions listed: Advanced Pancreatic Cancers. Primary outcome: Objective Response Rate; Adverse Event. Pancreatic eligibility wording from the registry: \"* Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic pancreatic adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06770439","url":"https://clinicaltrials.gov/study/NCT06770439"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy"],"targets":[],"drugs":["ibi343","gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06770439","phase":"2","setting":"A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer","sponsor":"Zhejiang University","started":"2025-04-18","startedType":"actual","enrolled":64,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07692750","kind":"trial","name":"IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of IBI343, capecitabine and cAPOX (capecitabine, oxaliplatin) in pancreatic cancer, run by Zhejiang Cancer Hospital, now recruiting.","summary":"IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer is a phase 1/2, interventional study registered as NCT07692750 by Zhejiang Cancer Hospital, with a registry enrolment figure of 56 participants, started 2025-04-30 and due to reach its primary completion in 2027-06-30. Interventions recorded: IBI343+ capecitabine; IBI343+Capecitabine+oxaliplatin. Conditions listed: Advanced Pancreatic Cancer. Primary outcome: Objective Response Rate (ORR) according to RECIST v1.1; Adverse Event, Treatment-Emergent Adverse Event, Adverse Event of Special Interest, Serious Serious Adverse EventChanges in laboratory tests, physical examinations, vital signs, etc., incidence, and correlation with experimental drugs. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07692750","url":"https://clinicaltrials.gov/study/NCT07692750"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy"],"targets":[],"drugs":["ibi343","capecitabine","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07692750","phase":"1/2","setting":"A Phase Ib/II Study to Evaluate the Safety, Tolerability and Efficacy of IBI343 in Combination With Chemotherapy in Subjects With Advanced Pancreatic Cancer","sponsor":"Zhejiang Cancer Hospital","started":"2025-04-30","startedType":"actual","enrolled":56,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07483554","kind":"trial","name":"IBI343 in Combination Therapy for Advanced Malignant Solid Tumors","aka":[],"tldr":"A phase 2 trial of IBI343, Gemcitabine in pancreatic ductal adenocarcinoma, run by Innovent Biologics (Suzhou) Co. Ltd., now recruiting.","summary":"IBI343 in Combination Therapy for Advanced Malignant Solid Tumors is a phase 2 interventional study registered as NCT07483554 by Innovent Biologics (Suzhou) Co. Ltd., with 389 participants planned, started 2026-04-20 and due to reach its primary completion in 2028-03-31. Interventions recorded: IBI343,Gemcitabine, Albumin-bound Paclitaxel. Conditions listed: CLDN18.2 Positive, Gastric/Gastroesophageal Junction Adenocarcinoma, Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07483554","url":"https://clinicaltrials.gov/study/NCT07483554"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["ibi343","gemcitabine"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07483554","phase":"2","setting":"A Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of IBI343 in Combination Therapy for Patients With Advanced Malignant Solid Tumors.","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","started":"2026-04-20","startedType":"actual","enrolled":389,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07198841","kind":"trial","name":"IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation","aka":[],"tldr":"A phase 2 trial of fulzerasib and cetuximab in lung cancer, run by Guangdong Association of Clinical Trials, now recruiting.","summary":"IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation is a phase 2, interventional study registered as NCT07198841 by Guangdong Association of Clinical Trials, with a registry enrolment figure of 48 participants, started 2025-11-03 and due to reach its primary completion in 2027-09. Interventions recorded: IBI351 combined with cetuximab β. Conditions listed: Lung Cancer (Non-Small Cell). Primary outcome: Objective Response Rate. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB/IIIC), metastatic, or recurrent (Stage IV) non-small cell lung cancer (NSCLC), per the International Association for the Study of Lung Cancer (IASLC) and American Joint Committee on Cancer (AJCC) 8th edition TNM stag\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07198841","url":"https://clinicaltrials.gov/study/NCT07198841"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["kras-g12c-nsclc"],"sections":[],"technologies":["kras-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["fulzerasib","cetuximab"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07198841","phase":"2","setting":"The Efficacy and Safety of IBI351 Plus Cetuximab β in Untreated, Locally Advanced or Metastatic Non-small Cell Lung Cancer With KRAS G12C Mutation: A Single-arm, Prospective, Multicenter Phase II Clinical Study","sponsor":"Guangdong Association of Clinical Trials","started":"2025-11-03","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07377643","kind":"trial","name":"IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial testing IBI354 in HER2-positive breast cancer, now recruiting.","summary":"IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer is a phase 3 interventional study registered as NCT07377643, led by Innovent Biopharmaceutical Technology (Hangzhou), and recruiting on the registry. Official title: A Randomised, Multicenter, Open-label Phase 3 Study to Compare IBI354 With or Without Pertuzumab vs. Taxane in Combination With Trastuzumab and Pertuzumab as First-line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Breast Cancer. Planned enrolment is 540 participants (estimated). The study started in 2026-02-10 and primary completion is expected in 2028-04-28. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07377643","url":"https://clinicaltrials.gov/study/NCT07377643"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["ibi354"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07377643","phase":"3","setting":"A Randomized, Multicenter, Open-label Phase 3 Study to Compare IBI354 With or Without Pertuzumab vs. Taxane in Combination With Trastuzumab and Pertuzumab as First-line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Breast Cancer","sponsor":"Innovent Biopharmaceutical Technology (Hangzhou)","started":"2026-02-10","startedType":"actual","enrolled":540,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07402070","kind":"trial","name":"IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of IBI363 in lung cancer, run by Innovent Biologics (Suzhou) Co. Ltd., not yet recruiting.","summary":"IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer is a phase 2, interventional study registered as NCT07402070 by Innovent Biologics (Suzhou) Co. Ltd., with a registry enrolment figure of 10 participants, started 2026-02-04 and due to reach its primary completion in 2026-12-31. Interventions recorded: IBI363. Conditions listed: Resectable Stage II-III Non-small Cell Lung Cancer. Primary outcome: Pathologic Complete Response (pCR) rate; Safety parameters: the incidence of Treatment-related Adverse Event, (TRAEs); Safety parameters: the incidence of treatment-emergent adverse events (TEAEs). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed primary NSCLC:\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07402070","url":"https://clinicaltrials.gov/study/NCT07402070"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ibi363"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07402070","phase":"2","setting":"A Phase II Study Evaluating the Efficacy and Safety of IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","started":"2026-02-04","startedType":"estimated","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07722494","kind":"trial","name":"IBI363 Combined With Bevacizumab for Advanced Colorectal Cancer","aka":[],"tldr":"A phase 3 trial of IBI363, Bevacizumab in colorectal cancer, run by Innovent Biologics (Suzhou) Co. Ltd., now recruiting.","summary":"IBI363 Combined With Bevacizumab for Advanced Colorectal Cancer is a phase 3 interventional study registered as NCT07722494 by Innovent Biologics (Suzhou) Co. Ltd., with 550 participants planned, started 2026-07-31 and due to reach its primary completion in 2028-10-31. Interventions recorded: IBI363 + bevacizumab, Investigator's choice of therapy. Conditions listed: Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07722494","url":"https://clinicaltrials.gov/study/NCT07722494"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["ibi363","bevacizumab"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07722494","phase":"3","setting":"A Randomized, Open-label, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI363 in Combination With Bevacizumab Versus Investigator's Choice of Therapy in Participants With Advanced Colorectal Cancer Who Have Failed or Are Intolerant to Standard Care of Therapy","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","started":"2026-07-31","startedType":"actual","enrolled":550,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07122687","kind":"trial","name":"IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small","aka":[],"tldr":"A phase 2 trial of Pemetrexed, Cisplatin, IBI363 in non-small-cell lung cancer and small-cell lung cancer, run by Innovent Biologics (Suzhou) Co. Ltd., now recruiting.","summary":"IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT07122687 by Innovent Biologics (Suzhou) Co. Ltd., with 170 participants planned, started 2025-08-26 and due to reach its primary completion in 2026-11-30. Interventions recorded: Pemetrexed, Cisplatin, IBI363, Carboplatin, Keytruda. Conditions listed: Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07122687","url":"https://clinicaltrials.gov/study/NCT07122687"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pemetrexed","cisplatin","ibi363","carboplatin","pembrolizumab"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07122687","phase":"2","setting":"A Phase II Study Evaluating the Efficacy and Safety of IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","started":"2025-08-26","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"ibis-i","kind":"trial","name":"IBIS-I (International Breast Intervention Study I)","aka":["IBIS-1","ISRCTN91879928"],"tldr":"The UK-led prevention trial that showed five years of tamoxifen keeps preventing breast cancer for at least twenty years, and the reason NICE tells the NHS to offer it to premenopausal women at high familial risk.","summary":"IBIS-I randomised 7,154 women at increased risk of breast cancer to tamoxifen or placebo for five years. At a median 16 years of follow-up, breast cancer (invasive plus ductal carcinoma in situ) occurred in 251 women in the tamoxifen arm and 350 in the placebo arm, a hazard ratio of 0.71, with the reduction as large after ten years as during the first ten; the effect was confined to oestrogen-receptor-positive disease and there was no difference in breast cancer mortality. Endometrial cancer and thromboembolism were increased mainly while the drug was being taken. With the American NSABP P-1 trial it is the evidence behind NICE CG164 recommendation 1.7.21, which tells the NHS to offer tamoxifen for five years to premenopausal women at high risk.","status":"positive","asOf":"2026-09-25","links":[{"label":"Lancet Oncology 2015 (DOI)","url":"https://doi.org/10.1016/S1470-2045(14)71171-4"},{"label":"ISRCTN91879928","url":"https://www.isrctn.com/ISRCTN91879928"},{"label":"NICE CG164 recommendations","url":"https://www.nice.org.uk/guidance/cg164/chapter/Recommendations"}],"tags":["uk","breast","prevention"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tamoxifen"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jack-cuzick"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN91879928","phase":"3","setting":"Prevention: tamoxifen 20 mg daily for five years against placebo in women aged 35 to 70 at increased risk of breast cancer","sponsor":"Queen Mary University of London (Cancer Research UK funded)","result":"Breast cancer in 251 of the tamoxifen arm against 350 of the placebo arm at a median 16 years, hazard ratio 0.71, with no difference in breast cancer mortality (Lancet Oncology 2015).","yearReported":2015,"enrolled":7154,"enrolledBasis":"registry","outcomes":[]},{"id":"ibis-ii","kind":"trial","name":"IBIS-II (International Breast Intervention Study II)","aka":["IBIS-2","IBIS-II Prevention","ISRCTN31488319"],"tldr":"The trial that made anastrozole a prevention drug, halving breast cancer in postmenopausal women at high risk and, with a licence granted in 2023, putting a generic tablet on the NHS prevention pathway.","summary":"IBIS-II randomised 3,864 postmenopausal women at increased risk of breast cancer to anastrozole or placebo for five years. After a median 131 months, 85 women in the anastrozole arm and 165 in the placebo arm had developed breast cancer, a hazard ratio of 0.51, with the benefit continuing after treatment stopped and no excess of fractures or cardiovascular disease in the post-treatment period. NICE CG164 recommendation 1.7.22, amended in 2023, tells the NHS to offer anastrozole for five years to postmenopausal women at high risk unless they have severe osteoporosis; the MHRA licensed anastrozole for prevention in 2023 through its repurposing programme.","status":"positive","asOf":"2026-09-25","links":[{"label":"Lancet 2020 (DOI)","url":"https://doi.org/10.1016/S0140-6736(19)32955-1"},{"label":"ISRCTN31488319","url":"https://www.isrctn.com/ISRCTN31488319"},{"label":"NICE CG164 recommendations","url":"https://www.nice.org.uk/guidance/cg164/chapter/Recommendations"}],"tags":["uk","breast","prevention"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["anastrozole","tamoxifen"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jack-cuzick"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN31488319","phase":"3","setting":"Prevention: anastrozole 1 mg daily for five years against placebo in postmenopausal women at increased risk of breast cancer","sponsor":"Queen Mary University of London (Cancer Research UK funded)","result":"Breast cancer in 85 of 1,920 on anastrozole against 165 of 1,944 on placebo after a median 131 months, hazard ratio 0.51 (Lancet 2020).","yearReported":2020,"enrolled":3864,"enrolledBasis":"registry","outcomes":[]},{"id":"ibra-study","kind":"trial","name":"iBRA (implant Breast Reconstruction evAluation)","aka":["iBRA study"],"tldr":"The study that counted what actually happens after an implant reconstruction in Britain, rather than what the best units report. One woman in eleven lost the implant, one in four needed treating for infection, and nearly one in five went back to theatre within three months. Every one of those rates is worse than the national standard allows.","summary":"iBRA recruited consecutively between February 2014 and June 2016, taking every woman aged 16 or over having any type of immediate implant-based reconstruction at 81 participating units, which is what makes it a picture of practice rather than of expertise. 2,108 patients had 2,655 mastectomies with immediate implant-based reconstruction, and three-month outcome data were available for 2,081 of them (99 percent).\n\nThe techniques used show how far mesh had spread before the evidence did: 1,376 patients (65 percent) had reconstruction with biological (1,133, 54 percent) or synthetic (243, 12 percent) mesh, 181 (9 percent) had non-mesh submuscular or subfascial implants, 440 (21 percent) had dermal sling implants, 42 (2 percent) had pre-pectoral implants, and 79 (4 percent) had another technique or a combination.\n\nWithin three months, 182 patients (9 percent, 95 percent confidence interval 8 to 10) lost the implant, 372 (18 percent, 16 to 20) were readmitted to hospital, 370 (18 percent, 16 to 20) returned to theatre for a complication, and 522 (25 percent, 23 to 27) needed treatment for an infection. The National Quality Standards ask for under 5 percent for re-operation, readmission and implant loss and under 10 percent for infection, so every one of those rates is above standard.\n\nThe study was designed to test whether a randomised trial of reconstruction techniques was feasible, and concluded that one is needed. Best-BRA is the answer to it. What iBRA cannot do is separate the effect of the mesh from the effect of everything else, because it is a cohort: it establishes that mesh was in majority use without randomised evidence, not that mesh caused the complication rate.","status":"completed","asOf":"2026-09-25","links":[{"label":"ISRCTN37664281","url":"https://www.isrctn.com/ISRCTN37664281"},{"label":"iBRA short-term safety outcomes (Lancet Oncology 2019)","url":"https://doi.org/10.1016/S1470-2045(18)30781-2"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["breast-reconstruction","mastectomy","oncoplastic-breast-surgery","bia-alcl"],"trials":["pre-bra","best-bra","mroc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN37664281","phase":"observational","setting":"Any immediate implant-based breast reconstruction after mastectomy for cancer or risk reduction, with or without biological or synthetic mesh, at 81 United Kingdom breast and plastic surgical units: implant loss, infection, unplanned return to theatre and unplanned readmission within three months","sponsor":"University of Bristol, funded by the National Institute for Health Research, the Association of Breast Surgery and the British Association of Plastic, Reconstructive and Aesthetic Surgeons","result":"Within three months of immediate implant-based reconstruction: implant loss 9 percent, infection needing treatment 25 percent, return to theatre 18 percent and readmission 18 percent, all above the National Quality Standards.","yearReported":2019,"enrolled":2108,"enrolledBasis":"registry","outcomes":[{"endpoint":"Implant loss within 3 months","primary":true,"unit":"%","arms":[{"name":"Immediate implant-based reconstruction, all techniques","n":2081,"value":9,"note":"182 patients, 95 percent confidence interval 8 to 10"}],"source":"https://doi.org/10.1016/S1470-2045(18)30781-2"},{"endpoint":"Infection needing antibiotics or surgery within 3 months","unit":"%","arms":[{"name":"Immediate implant-based reconstruction, all techniques","n":2081,"value":25,"note":"522 patients, 95 percent confidence interval 23 to 27"}],"source":"https://doi.org/10.1016/S1470-2045(18)30781-2"},{"endpoint":"Unplanned return to theatre within 3 months","unit":"%","arms":[{"name":"Immediate implant-based reconstruction, all techniques","n":2081,"value":18,"note":"370 patients, 95 percent confidence interval 16 to 20"}],"source":"https://doi.org/10.1016/S1470-2045(18)30781-2"}],"replication":"Pre-BRA found the same pattern for pre-pectoral placement specifically, with implant loss of 8.2 percent at three months."},{"id":"nct00582166","kind":"trial","name":"Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance","aka":[],"tldr":"A phase 2 trial of Ibritumomab tiuxetan and Rituximab in Non-Hodgkin lymphoma, run by University of Wisconsin, Madison, recorded as terminated on the registry.","summary":"Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance is a phase 2 interventional study registered as NCT00582166 by University of Wisconsin, Madison, with 18 participants recorded, started 2005-01-25 and due to reach its primary completion in 2013-03. Interventions recorded: Ibritumomab Tiuxetan (Zevalin) + Rituximab. Conditions recorded: Non-Hodgkin's Lymphoma.\n\nLinked to the drug Ibritumomab tiuxetan because the registry names it among its interventions and Non-Hodgkin lymphoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00582166","url":"https://clinicaltrials.gov/study/NCT00582166"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["ibritumomab-tiuxetan","rituximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00582166","phase":"2","setting":"Ibritumomab Tiuxetan Plus Rituximab as Initial Therapy for Patients With High Tumor Burden, Indolent Histology Non-Hodgkin's Lymphoma","sponsor":"University of Wisconsin, Madison","started":"2005-01-25","startedType":"actual","yearReported":2018,"enrolled":18,"enrolledBasis":"registry","outcomes":[{"endpoint":"Median Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Zevalin With Rituximab Maintenance","n":16,"value":44.3,"note":"80% CI 32.8 to 46.1; Figures from the ClinicalTrials.gov results section (first posted 2018-07-13), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00582166?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"%","arms":[{"name":"Zevalin With Rituximab Maintenance","n":16,"value":93,"note":"95% CI 80 to 100; Figures from the ClinicalTrials.gov results section (first posted 2018-07-13), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00582166?tab=results"}]},{"id":"nct06321081","kind":"trial","name":"ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Beijing Hospital, now recruiting.","summary":"ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC is a phase 2, interventional study registered as NCT06321081 by Beijing Hospital, with a registry enrolment figure of 60 participants, started 2024-03-01 and due to reach its primary completion in 2026-12-30. Interventions recorded: irinotecan, cetuximab, envafolimab. Conditions listed: RAS Mutation; Metastatic Colorectal Cancer; MSS. Primary outcome: progression free survival. Colorectal eligibility wording from the registry: \"Histologically proven diagnosis of colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06321081","url":"https://clinicaltrials.gov/study/NCT06321081"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06321081","phase":"2","setting":"ICE Study: a Clinical Study of the Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC","sponsor":"Beijing Hospital","started":"2024-03-01","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07487805","kind":"trial","name":"ICONIC: ivermectin combined with immune checkpoint inhibition in cancer (University of Florida phase 2)","aka":[],"tldr":"A University of Florida trial will randomise 80 people already on immunotherapy to two doses of ivermectin and measure a change in their immune cells after two weeks. It is not yet open and does not measure whether tumours shrink.","summary":"ICONIC is a randomised, parallel-arm phase 2 in 80 adults with solid tumours, due to start in September 2026 and reach its primary completion in September 2027 (ClinicalTrials.gov NCT07487805). The primary endpoint is the median fold-change at week 2 in Ki-67-positive, HLA-DR-positive non-naive CD8 T cells, a laboratory marker of T-cell activation, with adverse events and cytokine changes as secondary endpoints (ClinicalTrials.gov NCT07487805). The registry text explains the rationale: widespread off-label use after public claims, a 2023 survey in Loja, Ecuador in which 19 percent of respondents had used ivermectin alongside cancer treatment, virtually absent clinical data, and a reported case of severe neurotoxicity in a patient with metastatic osteosarcoma on regorafenib attributed to a CYP3A4 interaction (ClinicalTrials.gov NCT07487805).","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07487805","url":"https://clinicaltrials.gov/study/NCT07487805"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["checkpoint-inhibitor","drug-repurposing"],"targets":[],"drugs":["ivermectin"],"companies":[],"institutions":["uf-health-cancer-center"],"pathways":[],"terms":["immune-checkpoint","off-label","pharmacokinetics"],"trials":[],"people":[],"bottlenecks":["b-generic-repurposing","b-misinformation"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo agent (Claude Fable 5.1)","editedOn":"2026-09-24","note":"Written from cached ClinicalTrials.gov v2, Europe PMC, DailyMed, Drugs@FDA and WHO eEML responses; no figure appears without its source link."},"nct":"NCT07487805","phase":"2","setting":"Adults with solid tumours on a standard immune checkpoint inhibitor: randomised to 200 or 400 micrograms per kg of oral ivermectin on days 1 to 3 of each week for four weeks","sponsor":"University of Florida","result":"Not yet recruiting; no results (ClinicalTrials.gov NCT07487805).","started":"2026-09","startedType":"estimated","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"apex-03","kind":"trial","name":"ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)","aka":["APEX-03"],"tldr":"A phase 2/3 trial testing ICP-248 in chronic lymphocytic leukaemia, now recruiting.","summary":"ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma (APEX-03) is a phase 2/3 interventional study registered as NCT06378138, led by Beijing InnoCare Pharma Tech, and recruiting on the registry. Official title: A Phase II/III Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma. Planned enrolment is 226 participants (estimated). The study started in 2024-05-15 and primary completion is expected in 2030-11-25. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06378138","url":"https://clinicaltrials.gov/study/NCT06378138"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":[],"targets":[],"drugs":["icp-248"],"companies":["innocare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06378138","phase":"2/3","setting":"A Phase II/III Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","sponsor":"Beijing InnoCare Pharma Tech","started":"2024-05-15","startedType":"actual","enrolled":226,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05987332","kind":"trial","name":"IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma","aka":["DAR-UM-2"],"tldr":"A phase 2/3 trial of Darovasertib, Crizotinib, Pembrolizumab in melanoma and uveal melanoma, run by IDEAYA Biosciences, active and no longer recruiting.","summary":"IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma is a phase 2/3 interventional study registered as NCT05987332 by IDEAYA Biosciences, with 420 participants planned, started 2023-10-31 and due to reach its primary completion in 2027-01-15. Interventions recorded: IDE196, Crizotinib, Pembrolizumab, Ipilimumab, Nivolumab. Conditions listed: Metastatic Uveal Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05987332","url":"https://clinicaltrials.gov/study/NCT05987332"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","uveal-melanoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["darovasertib","crizotinib","pembrolizumab","ipilimumab","nivolumab","dacarbazine"],"companies":["ideaya-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05987332","phase":"2/3","setting":"IDE196 (Darovasertib) in Combination With Crizotinib Versus Investigator's Choice of Treatment as First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma (DAR-UM-2)","sponsor":"IDEAYA Biosciences","started":"2023-10-31","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"idea-collaboration","kind":"trial","name":"IDEA collaboration","aka":["International Duration Evaluation of Adjuvant chemotherapy","IDEA"],"tldr":"Six national trials pooled their results to ask whether three months of chemotherapy after bowel cancer surgery is as good as six. For low-risk disease it is, and it causes far less nerve damage.","summary":"IDEA was a prospective, preplanned pooled analysis of six concurrent phase 3 non-inferiority trials in resected stage III colon cancer. Across 12,834 patients and 3,263 events the non-inferiority of three months was not confirmed overall (hazard ratio 1.07, 95% CI 1.00 to 1.15 against a margin of 1.12), but it held for CAPOX (0.95, 0.85 to 1.06) and not for FOLFOX (1.16, 1.06 to 1.26). In the exploratory low-risk group (T1 to T3 and N1) three-year disease-free survival was 83.1 against 83.3 percent (hazard ratio 1.01); in T4 or N2 disease six months was better. Grade 2 or worse neuropathy roughly halves with the shorter course. The result is the two-tier recommendation in every guideline: three months of CAPOX for low-risk stage III, six months of FOLFOX or CAPOX for T4 or N2 disease.","status":"mixed","asOf":"2026-09-24","links":[{"label":"IDEA: duration of adjuvant chemotherapy for stage III colon cancer (New England Journal of Medicine 2018)","url":"https://doi.org/10.1056/NEJMoa1713709"}],"tags":[],"related":[],"cancers":["colorectal","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","capox","oxaliplatin","capecitabine","fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","de-escalation"],"trials":["scot","tosca","mosaic"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Stage III colon cancer after resection: three months of adjuvant FOLFOX or CAPOX against six months, pooled across six trials","sponsor":"Six concurrent trial groups (SCOT, TOSCA, IDEA France, CALGB/SWOG 80702, ACHIEVE, HORG)","result":"Three months non-inferior to six for CAPOX and for low-risk (T1-3 N1) disease; six months better for T4 or N2.","yearReported":2018,"enrolled":12834,"enrolledBasis":"analysed","enrolledNote":"A prospective pooled analysis of six randomised trials rather than a single registration; 12,834 patients were analysed after 3,263 events.","outcomes":[{"endpoint":"Disease-free survival at 3 years (overall)","primary":true,"unit":"hazard ratio","arms":[{"name":"3 months","value":1.07,"note":"non-inferiority not confirmed"},{"name":"6 months","value":1}],"hr":1.07,"ci":[1,1.15],"source":"https://doi.org/10.1056/NEJMoa1713709"},{"endpoint":"Disease-free survival at 3 years (T1-3 N1)","unit":"percent","arms":[{"name":"3 months","value":83.1},{"name":"6 months","value":83.3}],"hr":1.01,"ci":[0.9,1.12],"source":"https://doi.org/10.1056/NEJMoa1713709"}]},{"id":"ideate-lung02","kind":"trial","name":"IDeate-Lung02","aka":["ideate-lung02"],"tldr":"IDeate-Lung02 is the pivotal trial for the B7-H3 ADC that produced some of the highest response rates ever seen in relapsed small-cell lung cancer.","summary":"IDeate-Lung02, trial NCT06203210 sponsored by Daiichi Sankyo and Merck, is the pivotal phase 3 for ifinatamab deruxtecan, the B7-H3 antibody-drug conjugate that produced some of the highest response rates ever seen in relapsed small-cell lung cancer. It compares the drug with topotecan, amrubicin or lurbinectedin after one prior line, with objective response rate and overall survival as primary endpoints, following IDeate-Lung01, in which more than half of patients responded at the 12 mg/kg dose. OnCo links it to small-cell lung cancer, B7-H3 as a target, ifinatamab deruxtecan, topotecan and lurbinectedin. It is recruiting with no results, is positioned to compete with tarlatamab in the second line, and how the two should be sequenced is the open question.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06203210","url":"https://clinicaltrials.gov/study/NCT06203210"},{"label":"Trial design paper","url":"https://pubmed.ncbi.nlm.nih.gov/41055143/"}],"tags":[],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["adc"],"targets":["b7h3"],"drugs":["ifinatamab-deruxtecan","topotecan","lurbinectedin","amrubicin"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06203210","phase":"3","setting":"Relapsed SCLC after one prior line: ifinatamab deruxtecan vs topotecan, amrubicin, or lurbinectedin","sponsor":"Daiichi Sankyo / Merck","started":"2024-05-21","startedType":"actual","enrolled":540,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03803553","kind":"trial","name":"Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer","aka":[],"tldr":"A phase 3 trial of encorafenib, binimetinib, trastuzumab and pertuzumab in colorectal cancer, run by Massachusetts General Hospital, active but no longer recruiting.","summary":"Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer is a phase 3, randomised interventional study registered as NCT03803553 by Massachusetts General Hospital, with a registry enrolment figure of 400 participants, started 2020-04-16 and due to reach its primary completion in 2026-12. Interventions recorded: FOLFIRI Protocol; ACTIVE SURVEILLANCE; Nivolumab Protocol; Encorafenib/Binimetinib/Cetuximab Protocol; Trastuzumab + Pertuzumab. Conditions listed: Metastatic Colon Cancer; Stage III Colon Cancer. Primary outcome: Disease-free survival (DFS); Clearance rate of ctDNA. Colorectal eligibility wording from the registry: \"* Participants must have histologically confirmed resected Stage III adenocarcinoma of the colon\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03803553","url":"https://clinicaltrials.gov/study/NCT03803553"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["encorafenib","binimetinib","trastuzumab","pertuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03803553","phase":"3","setting":"Early Identification and Treatment of Occult Metastatic Disease in Stage III Colon Cancer","sponsor":"Massachusetts General Hospital","started":"2020-04-16","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06119685","kind":"trial","name":"IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers","aka":[],"tldr":"A phase 1/2 trial of Rituximab, Daratumumab, Aldesleukin in multiple myeloma and hodgkin lymphoma, run by Indapta Therapeutics, INC., now recruiting.","summary":"IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers is a phase 1/2 interventional study registered as NCT06119685 by Indapta Therapeutics, INC., with 128 participants planned, started 2023-10-25 and due to reach its primary completion in 2025-12-30. Interventions recorded: IDP-023, Rituximab, Daratumumab, Interleukin-2, Cyclophosphamide. Conditions listed: NHL, Multiple Myeloma, Blood Cancer, Refractory Non-Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06119685","url":"https://clinicaltrials.gov/study/NCT06119685"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["rituximab","daratumumab","aldesleukin","cyclophosphamide","fludarabine","mesna"],"companies":["indapta-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06119685","phase":"1/2","setting":"Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers","sponsor":"Indapta Therapeutics, INC.","started":"2023-10-25","startedType":"actual","enrolled":128,"enrolledBasis":"registry","outcomes":[]},{"id":"ielsg-19","kind":"trial","name":"IELSG-19","aka":["IELSG19","Chlorambucil versus rituximab versus both in MALT lymphoma"],"tldr":"The first randomised trial of first-line drug treatment for MALT lymphoma found that combining an old tablet with an antibody delayed relapse better than either alone, without anyone living longer.","summary":"Mucosa-associated lymphoid tissue lymphoma is common enough to matter and rare enough that nobody had randomised its systemic treatment. IELSG-19 did. The first 252 patients were randomised between chlorambucil alone and chlorambucil with rituximab; the protocol was then amended to a three-arm design adding rituximab alone, to a final 454 patients.\n\nAt a median follow-up of 7.4 years, five-year event-free survival was 51 per cent (95 per cent confidence interval 42 to 60) with chlorambucil alone, 50 per cent (42 to 59) with rituximab alone and 68 per cent (60 to 76) with the combination (p = 0.0009). The hazard ratio for the combination against chlorambucil alone was 0.54 (0.38 to 0.77). Progression-free survival also favoured the combination (p = 0.0119). Five-year overall survival was approximately 90 per cent in all three arms, and all treatments were well tolerated.\n\nThe practical reading: for MALT lymphoma that needs systemic treatment, the combination is the better choice if the aim is to stay in remission, and the near-identical survival across arms is a reminder that this disease rarely kills quickly. Most gastric cases never reach this trial at all, because eradicating Helicobacter pylori clears them.","status":"mixed","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT00210353","url":"https://clinicaltrials.gov/study/NCT00210353"},{"label":"Journal of Clinical Oncology 2017","url":"https://doi.org/10.1200/JCO.2016.70.6994"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["malt-lymphoma","marginal-zone-lymphoma","non-hodgkin-lymphoma"],"sections":["immunotherapy","chemotherapy"],"technologies":["monoclonal-antibody"],"targets":["cd20"],"drugs":["chlorambucil","rituximab"],"companies":["ielsg"],"institutions":[],"pathways":[],"terms":["watchful-waiting"],"trials":[],"people":[],"bottlenecks":["b-rare-cancers","b-trial-enrolment"],"keyPapers":["paper-ielsg-19-chlorambucil-rituximab-malt-jco-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00210353","phase":"3","setting":"Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue needing systemic treatment: chlorambucil, rituximab, or both","sponsor":"International Extranodal Lymphoma Study Group (IELSG)","result":"Five-year event-free survival 68 per cent with chlorambucil and rituximab against 51 and 50 per cent for either alone, with five-year overall survival about 90 per cent in all three arms.","started":"2003-01","yearReported":2017,"enrolled":454,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Chlorambucil with rituximab","value":68,"note":"95 per cent confidence interval 60 to 76"},{"name":"Chlorambucil alone","value":51,"note":"42 to 60"},{"name":"Rituximab alone","value":50,"note":"42 to 59"}],"hr":0.54,"ci":[0.38,0.77],"p":"0.0009","source":"https://doi.org/10.1200/JCO.2016.70.6994"}],"replication":"The only randomised first-line systemic trial in this disease."},{"id":"ielsg32","kind":"trial","name":"IELSG32","aka":["IELSG-32","MATRix trial"],"tldr":"IELSG32 built the MATRix regimen that is now the standard first treatment for lymphoma confined to the brain: adding rituximab and thiotepa to methotrexate and cytarabine doubled the complete remission rate, and its second part showed that a stem cell transplant works as well as whole-brain radiotherapy for consolidation, with less harm to thinking.","summary":"IELSG32 was an international randomised phase 2 trial in 227 patients with newly diagnosed primary CNS lymphoma. The first randomisation compared four courses of high-dose methotrexate and cytarabine alone (arm A), with rituximab (arm B), or with rituximab and thiotepa (arm C, the MATRix regimen). Patients with responsive or stable disease were then randomised to whole-brain radiotherapy of 36 Gy or high-dose carmustine and thiotepa with autologous stem cell transplant.\n\nComplete remission after induction was 49 percent with MATRix against 23 percent with methotrexate-cytarabine alone and 30 percent with rituximab added, with more grade 4 haematological toxicity but similar infections; 6 percent of patients died of toxicity. In the second randomisation two-year failure-free survival was 76 percent after radiotherapy and 75 percent after transplant, with cognitive function preserved after transplant and impaired attention and executive function after radiotherapy. The corpus's primary CNS lymphoma page cites IELSG32 for thiotepa-based chemotherapy with autologous transplant.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01011920","url":"https://clinicaltrials.gov/study/NCT01011920"}],"tags":["soc-trials"],"related":["lymphoma-roadmap","ielsg43","prima-cns"],"cancers":["primary-cns-lymphoma","non-hodgkin-lymphoma","brain-tumours"],"sections":[],"technologies":["cytotoxic-chemotherapy","autologous-stem-cell-transplant"],"targets":[],"drugs":["methotrexate","cytarabine","thiotepa","rituximab","carmustine"],"companies":["ielsg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-ielsg32-matrix-induction-ferreri-lancet-haematol-2016","paper-ielsg32-wbrt-vs-asct-consolidation-ferreri-lancet-haematol-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01011920","phase":"2","setting":"Newly diagnosed primary central nervous system lymphoma in immunocompetent patients aged 18 to 70: a first randomisation between high-dose methotrexate and cytarabine alone, with rituximab, or with rituximab and thiotepa (MATRix), and a second randomisation between whole-brain radiotherapy and carmustine-thiotepa conditioned autologous transplant as consolidation","sponsor":"International Extranodal Lymphoma Study Group (IELSG)","result":"Complete remission 49 percent with MATRix (methotrexate, cytarabine, thiotepa, rituximab) against 23 percent with methotrexate-cytarabine alone; two-year failure-free survival 76 percent after whole-brain radiotherapy and 75 percent after autologous transplant.","started":"2009-11","yearReported":2016,"enrolled":227,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete remission after induction chemotherapy","primary":true,"unit":"%","arms":[{"name":"MATRix: methotrexate, cytarabine, thiotepa, rituximab","value":49,"note":"95% CI 38 to 60; 219 of 227 assessable across the three arms"},{"name":"Methotrexate + cytarabine + rituximab","value":30,"note":"95% CI 21 to 42"},{"name":"Methotrexate + cytarabine","value":23,"note":"95% CI 14 to 31"}],"source":"https://doi.org/10.1016/S2352-3026(16)00036-3"},{"endpoint":"Failure-free survival at 2 years after the second randomisation","primary":true,"unit":"%","arms":[{"name":"Whole-brain radiotherapy 36 Gy with or without 9 Gy boost","value":76,"note":"95% CI 65 to 87"},{"name":"Carmustine-thiotepa conditioning and autologous stem cell transplant","value":75,"note":"95% CI 64 to 86"}],"source":"https://doi.org/10.1016/S2352-3026(17)30174-6"},{"endpoint":"Deaths from toxicity during induction","unit":"%","arms":[{"name":"All induction arms","n":219,"value":6}],"source":"https://doi.org/10.1016/S2352-3026(16)00036-3"}]},{"id":"ielsg37","kind":"trial","name":"IELSG37","aka":[],"tldr":"IELSG37 showed that people with primary mediastinal B-cell lymphoma whose scan is clear after chemotherapy do not need radiotherapy to the chest, sparing young patients decades of heart and breast cancer risk.","summary":"IELSG37 registered 545 patients with primary mediastinal large B-cell lymphoma treated with rituximab-containing immunochemotherapy (mostly R-CHOP or dose-adjusted EPOCH-R, by centre) and randomised the 268 who reached a complete metabolic response on end-of-treatment PET (Deauville 1 to 3) to 30 Gy consolidation radiotherapy or to observation.\n\nProgression-free survival at 30 months was 96.7 percent without radiotherapy and 98.5 percent with it, within the non-inferiority margin, with no difference in overall survival. Patients with residual PET uptake were not randomised and received radiotherapy, in whom outcomes were also good.\n\nThe trial settled a forty-year argument: mediastinal radiotherapy can be omitted in the majority of patients who reach complete metabolic response, and PET now decides who is irradiated.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01599559","url":"https://clinicaltrials.gov/study/NCT01599559"},{"label":"Journal of Clinical Oncology 2024","url":"https://doi.org/10.1200/JCO.24.01373"}],"tags":[],"related":[],"cancers":["primary-mediastinal-b-cell-lymphoma"],"sections":[],"technologies":["fdg-pet","pet-adapted-therapy","imrt-igrt"],"targets":[],"drugs":["rituximab"],"companies":["ielsg"],"institutions":[],"pathways":[],"terms":["deauville-score","r-chop","lugano-classification"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01599559","phase":"3","setting":"Primary mediastinal large B-cell lymphoma in complete metabolic response on PET after rituximab-based immunochemotherapy: consolidation mediastinal radiotherapy versus observation","sponsor":"International Extranodal Lymphoma Study Group","result":"30-month progression-free survival 96.7% (observation) vs 98.5% (radiotherapy) in patients with complete metabolic response; radiotherapy can be omitted.","started":"2012-10","startedType":"actual","yearReported":2024,"enrolled":545,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 30 months","primary":true,"unit":"%","arms":[{"name":"Observation","n":132,"value":96.7},{"name":"Consolidation radiotherapy 30 Gy","n":136,"value":98.5}],"source":"https://doi.org/10.1200/JCO.24.01373"}],"replication":"Consistent with the single-arm National Cancer Institute DA-EPOCH-R series, in which no patient received radiotherapy and event-free survival was 93 percent."},{"id":"nct03608631","kind":"trial","name":"iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation is a phase 1/2, interventional study registered as NCT03608631 by M.D. Anderson Cancer Center, with a registry enrolment figure of 28 participants, started 2021-01-27 and due to reach its primary completion in 2027-04-30. Interventions recorded: Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA. Conditions listed: KRAS NP_004976.2:p.G12D; Metastatic Pancreatic Adenocarcinoma; Pancreatic Ductal Adenocarcinoma; Stage IV Pancreatic Cancer AJCC v8. Primary outcome: Maximum Tolerated Dose Determined by Dose Limiting Toxicity; Minimal residual disease rate in high-risk patients; Overall survival (OS). Pancreatic eligibility wording from the registry: \"* Patients with histologically confirmed metastatic pancreatic ductal adenocarcinoma harboring KrasG12D mutation\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03608631","url":"https://clinicaltrials.gov/study/NCT03608631"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03608631","phase":"1/2","setting":"Phase I Study of Mesenchymal Stromal Cells-Derived Exosomes With KrasG12D siRNA for Metastatic Pancreas Cancer Patients Harboring KrasG12D Mutation","sponsor":"M.D. Anderson Cancer Center","started":"2021-01-27","startedType":"actual","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05280470","kind":"trial","name":"Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)","aka":["IDeate-Lung01"],"tldr":"A phase 2 trial of Ifinatamab deruxtecan in small-cell lung cancer, run by Daiichi Sankyo, active and no longer recruiting.","summary":"Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC) is a phase 2 interventional study registered as NCT05280470 by Daiichi Sankyo, with 187 participants enrolled, started 2022-03-09 and due to reach its primary completion in 2025-03-03. Interventions recorded: Ifinatamab Deruxtecan (I-DXd). Conditions listed: Extensive-stage Small-cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05280470","url":"https://clinicaltrials.gov/study/NCT05280470"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["ifinatamab-deruxtecan"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05280470","phase":"2","setting":"A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)","sponsor":"Daiichi Sankyo","started":"2022-03-09","startedType":"actual","enrolled":187,"enrolledBasis":"registry","outcomes":[]},{"id":"ifm-2009","kind":"trial","name":"IFM 2009","aka":["IFM/DFCI 2009","IFM 2009 trial"],"tldr":"IFM 2009 asked whether a stem cell transplant is still needed when myeloma is treated with modern three-drug therapy; the transplant kept the disease away for longer, though patients lived about as long either way because those who relapsed could be transplanted later.","summary":"The French IFM 2009 trial randomised 700 adults up to 65 with newly diagnosed multiple myeloma to eight cycles of lenalidomide, bortezomib and dexamethasone (RVD), or to three cycles of RVD, high-dose melphalan with autologous stem cell transplant and two further RVD cycles. Both arms received one year of lenalidomide maintenance. The primary endpoint was progression-free survival.\n\nEarly transplant lengthened progression-free survival and produced deeper responses, including more patients with no detectable minimal residual disease, but overall survival was similar because most patients in the RVD-alone arm received a transplant at relapse. The trial, and the parallel DETERMINATION trial in the United States, defined transplant as a component that lengthens remission rather than life in the era of triplet induction, and framed the current question of whether quadruplets and CAR-T can replace it.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01191060","url":"https://clinicaltrials.gov/study/NCT01191060"}],"tags":["subtype-trials"],"related":[],"cancers":["myeloma-transplant-eligible","multiple-myeloma"],"sections":[],"technologies":["protac-degrader"],"targets":[],"drugs":["lenalidomide","bortezomib","dexamethasone"],"companies":["ifm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["michel-attal"],"bottlenecks":[],"keyPapers":["paper-ifm-2009-attal-nejm-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01191060","phase":"3","setting":"Newly diagnosed multiple myeloma in patients up to 65: lenalidomide, bortezomib and dexamethasone (RVD) alone against RVD with early autologous stem cell transplant, both followed by lenalidomide maintenance","sponsor":"Intergroupe Francophone du Myelome (University Hospital Toulouse)","result":"Early autologous transplant after RVD lengthened progression-free survival compared with RVD alone, with similar overall survival at first analysis.","started":"2010-10","startedType":"actual","yearReported":2017,"enrolled":700,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"RVD + high-dose melphalan and transplantation","n":350,"value":50},{"name":"RVD alone","n":350,"value":36}],"hr":0.65,"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1611750"},{"endpoint":"Complete response","unit":"%","arms":[{"name":"RVD + high-dose melphalan and transplantation","value":59},{"name":"RVD alone","value":48}],"p":"0.03","source":"https://doi.org/10.1056/NEJMoa1611750"},{"endpoint":"Minimal residual disease not detected","unit":"%","arms":[{"name":"RVD + high-dose melphalan and transplantation","value":79},{"name":"RVD alone","value":65}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1611750"},{"endpoint":"Overall survival at 4 years","unit":"%","arms":[{"name":"RVD + high-dose melphalan and transplantation","value":81},{"name":"RVD alone","value":82}],"source":"https://doi.org/10.1056/NEJMoa1611750"}]},{"id":"ignyte-eso","kind":"trial","name":"IGNYTE-ESO","aka":[],"tldr":"IGNYTE-ESO was the pivotal study for the second sarcoma TCR-T, with responses in 42% of patients with two rare sarcomas.","summary":"IGNYTE-ESO, trial NCT03967223 sponsored by Adaptimmune and GSK and reported in 2024, was the pivotal single-arm study for letetresgene autoleucel, the second engineered T-cell receptor therapy for sarcoma, with responses in 42 percent of patients with two rare sarcomas. In 64 patients with advanced NY-ESO-1-positive, HLA-A*02-positive synovial sarcoma or myxoid round cell liposarcoma the response rate by independent review was 42 percent in both histologies, with durable responses especially in synovial sarcoma and expected cytopenias and cytokine release syndrome, the basis for a biologics licence application due from US WorldMeds by the end of 2026. OnCo links it to sarcomas, TCR-T cell therapy and letetresgene autoleucel. Whether a small private company can bring a second TCR-T to market after Adaptimmune's retreat is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03967223","url":"https://clinicaltrials.gov/study/NCT03967223"}],"tags":[],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":["tcr-t"],"targets":[],"drugs":["letetresgene-autoleucel"],"companies":["adaptimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03967223","phase":"2","setting":"Advanced synovial sarcoma or myxoid/round cell liposarcoma, NY-ESO-1+, HLA-A*02+: lete-cel (single arm)","sponsor":"Adaptimmune / GSK","result":"ORR 42%.","started":"2019-12-31","startedType":"actual","yearReported":2024,"enrolled":64,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Lete-cel","n":64,"value":42}],"source":"https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2500"}]},{"id":"nct07452224","kind":"trial","name":"ILKN421H Plus Pembrolizumab in Advanced Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by iLeukon Therapeutics, Inc., now recruiting.","summary":"ILKN421H Plus Pembrolizumab in Advanced Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT07452224 by iLeukon Therapeutics, Inc., with 80 participants planned, started 2026-06-29 and due to reach its primary completion in 2029-06. Interventions recorded: ILKN421H, Pembrolizumab. Conditions listed: Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07452224","url":"https://clinicaltrials.gov/study/NCT07452224"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07452224","phase":"2","setting":"An Open-Label Phase II Study of ILKN421H in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","sponsor":"iLeukon Therapeutics, Inc.","started":"2026-06-29","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07680439","kind":"trial","name":"Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).","aka":[],"tldr":"A phase 2 trial of BCB-276 in diffuse midline glioma, h3 k27-altered, run by BrainChild Bio, Inc, now recruiting.","summary":"Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG). is a phase 2 interventional study registered as NCT07680439 by BrainChild Bio, Inc, with 75 participants planned, started 2026-08 and due to reach its primary completion in 2028-10. Interventions recorded: BCB-276. Conditions listed: Diffuse Intrinsic Pontine Glioma, DIPG, Brain Tumor, CNS Tumor. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07680439","url":"https://clinicaltrials.gov/study/NCT07680439"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dipg-dmg"],"sections":[],"technologies":[],"targets":[],"drugs":["bcb-276"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07680439","phase":"2","setting":"A Phase 2 Pivotal Study of BCB-276, a B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma","sponsor":"BrainChild Bio, Inc","started":"2026-08","startedType":"estimated","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05958121","kind":"trial","name":"IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of IMA402 in advanced solid tumours, run by Immatics Biotechnologies GmbH, now recruiting.","summary":"IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors is a phase 1/2 interventional study registered as NCT05958121 by Immatics Biotechnologies GmbH, with 400 participants planned, started 2023-08-09 and due to reach its primary completion in 2027-09. Interventions recorded: IMA402, IMA402 and checkpoint inhibitor, IMA402 and chemotherapy, IMA402 and IMA401, IMA402 and monoclonal antibody and IMA402 and chemotherapy +/- monoclonal antibody.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05958121","url":"https://clinicaltrials.gov/study/NCT05958121"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["prame"],"drugs":[],"companies":["immatics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05958121","phase":"1/2","setting":"A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) Targeting PRAME, as Monotherapy or in Combination With a Checkpoint Inhibitor in Patients With Recurrent and/or Refractory Solid Tumors","sponsor":"Immatics Biotechnologies GmbH","started":"2023-08-09","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"imagine-varnimcabtagene","kind":"trial","name":"IMAGINE (varnimcabtagene autoleucel, Immuneel)","aka":[],"tldr":"The first industry-run CAR-T trial in India, testing a Bengaluru-made version of a Barcelona hospital's cell therapy in relapsed lymphoma and leukaemia; it led to the approval of Qartemi.","summary":"IMAGINE is Immuneel's phase 2 study of varnimcabtagene autoleucel (IMN-003A), the Indian version of the academic CD19 CAR-T ARI-0001 from Hospital Clinic de Barcelona, in relapsed or refractory B-cell malignancies. Results including a B-cell non-Hodgkin lymphoma subanalysis, a cytokine profile and a prognostic score (the Bengaluru Score) were presented at the International Conference on Malignant Lymphoma and ASH in 2023. The trial supported CDSCO market authorisation of Qartemi for relapsed or refractory B-cell lymphoma in 2024. Full peer-reviewed efficacy figures for the Indian cohort were not available on the linked pages at the time of writing; the Spanish programme's published results are on the product page.","status":"positive","asOf":"2026-09-10","links":[{"label":"IMAGINE B-NHL subanalysis (Hematol Oncol 2023)","url":"https://doi.org/10.1002/hon.3165_632"},{"label":"Cytokine profile (Blood 2023, ASH abstract)","url":"https://doi.org/10.1182/blood-2023-181585"},{"label":"Bengaluru Score (Blood 2023, ASH abstract)","url":"https://doi.org/10.1182/blood-2023-181120"}],"tags":[],"related":[],"cancers":["dlbcl","all-leukemia"],"sections":[],"technologies":["car-t","point-of-care-cell-manufacturing"],"targets":["cd19"],"drugs":["varnimcabtagene-autoleucel"],"companies":["immuneel"],"institutions":["narayana-health"],"pathways":[],"terms":["crs"],"trials":[],"people":[],"bottlenecks":["b-manufacturing-cell-therapy","b-global-access"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"2","setting":"Relapsed or refractory B-cell malignancies (B-cell non-Hodgkin lymphoma and B-ALL), adults, India","sponsor":"Immuneel Therapeutics","yearReported":2023,"enrolled":24,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate at the primary endpoint","primary":true,"unit":"%","arms":[{"name":"Varnimcabtagene autoleucel (IMN-003A)","n":21,"value":80.9,"note":"17 of 21 evaluable patients (B-cell NHL and B-ALL combined); 24 infused; median PFS not reached at the ASH 2023 cut, relapse in 9 of 24"}],"source":"https://doi.org/10.1182/blood-2023-181120"},{"endpoint":"Cytokine release syndrome, any grade","unit":"%","arms":[{"name":"Varnimcabtagene autoleucel (IMN-003A)","n":24,"value":66.7,"note":"Grade 1 in 62.5%, grade 3 or higher in 4.2%; ICANS 4.2% (grade 1 only)"}],"source":"https://doi.org/10.1182/blood-2023-181585"}],"replication":"Figures come from ASH 2023 abstracts, not a full paper. The Indian product is the ARI-0001 construct from Hospital Clinic de Barcelona, whose CART19-BE-01 trial and compassionate-use series (including a 2026 mantle cell lymphoma report, ORR 89%) show similar activity and low rates of severe CRS, so the Bengaluru result replicates the Spanish programme in a new manufacturing site rather than an independent design."},{"id":"nct06107374","kind":"trial","name":"Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG","aka":[],"tldr":"A phase 2 trial of [18F]F-AraG in non-small-cell lung cancer, run by CellSight Technologies, Inc., now recruiting.","summary":"Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG is a phase 2 interventional study registered as NCT06107374 by CellSight Technologies, Inc., with 20 participants planned, started 2023-11-01 and due to reach its primary completion in 2025-12-31. Interventions recorded: [18F]F-AraG.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06107374","url":"https://clinicaltrials.gov/study/NCT06107374"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":["pd1","pdl1"],"drugs":[],"companies":["cellsight-technologies"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06107374","phase":"2","setting":"Imaging of T-cell Activation With [18F]F-araG in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1 Directed Therapy","sponsor":"CellSight Technologies, Inc.","started":"2023-11-01","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03673943","kind":"trial","name":"Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE","aka":[],"tldr":"A phase 3 trial of Somatostatin receptor PET in Neuroendocrine tumours, run by Radiomedix, Inc., completed.","summary":"Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE is a phase 3 interventional study registered as NCT03673943 by Radiomedix, Inc., with 63 participants recorded, started 2018-08-23 and reaching its primary completion in 2019-03-23. Interventions recorded: 64Cu-DOTATATE. Conditions recorded: Neuroendocrine Tumors.\n\nLinked to the technology Somatostatin receptor PET because the registry names it (\"64cu dotatate\") among its interventions and Neuroendocrine tumours among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03673943","url":"https://clinicaltrials.gov/study/NCT03673943"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine"],"sections":[],"technologies":["sstr-pet"],"targets":[],"drugs":[],"companies":["radiomedix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03673943","phase":"3","setting":"An Open-label, Single-dose, Single Arm, Single-center Clinical Trial of 64Cu(Copper)-DOTATATE (NETMedix™) PET-CT Scan for Imaging Patients With Known or Suspected Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)","sponsor":"Radiomedix, Inc.","started":"2018-08-23","startedType":"actual","enrolled":63,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02815033","kind":"trial","name":"Imaging Staging and Response Prediction in Metastatic Hormono-Sensitive Prostate Cancer Patients Receiving Enzalutamide","aka":[],"tldr":"A phase 2 trial of Whole-body MRI in Prostate cancer, run by The European Uro-Oncology Group, completed.","summary":"Imaging Staging and Response Prediction in Metastatic Hormono-Sensitive Prostate Cancer Patients Receiving Enzalutamide is a phase 2 interventional study registered as NCT02815033 by The European Uro-Oncology Group, with 66 participants recorded, started 2015-07 and reaching its primary completion in 2020-06. Interventions recorded: Enzalutamide, 11C or 18F-Choline PET/CT, Whole body MRI, Bone scan. Conditions recorded: Prostate Cancer Metastatic.\n\nLinked to the technology Whole-body MRI because the registry names it (\"whole body mri\") among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02815033","url":"https://clinicaltrials.gov/study/NCT02815033"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["whole-body-mri"],"targets":[],"drugs":["enzalutamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02815033","phase":"2","setting":"An Exploratory Phase 2, Open-label, Single-arm, Efficacy and Imaging Study of Oral Enzalutamide (XTANDI) Androgen Receptor (AR)-Directed Therapy in Hormono-Sensitive Patients With Metastatic Prostate Cancer (Hormono-sensitive Patients)","sponsor":"The European Uro-Oncology Group","started":"2015-07","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"imbassador250","kind":"trial","name":"IMbassador250","aka":["IMbassador250","IMbassador 250"],"tldr":"Adding a checkpoint inhibitor to enzalutamide did not help men with advanced prostate cancer live longer, and the trial explained why: prostate tumours carry very little of what these drugs need.","summary":"IMbassador250 enrolled 759 men with metastatic castration-resistant prostate cancer whose disease had progressed on abiraterone and randomised them open-label to atezolizumab with enzalutamide or enzalutamide alone. The primary endpoint of improved overall survival was not met in the unselected population: stratified hazard ratio 1.12 (95 percent confidence interval 0.91 to 1.37, p=0.28), with an acceptable safety profile.\n\nThe value of the trial is in its translational work, which is the best published account of why immunotherapy fails in prostate cancer. Archival tumour samples showed comparatively low expression of key immune biomarkers. DNA damage-response alterations, PTEN status and PD-L1 expression were similar between hormone-sensitive and castration-resistant tumours, so the disease does not become more immunogenic as it progresses.\n\nIn planned biomarker analysis, longer progression-free survival with atezolizumab was seen in men with high PD-L1 on immune cells (IC2/3), high CD8 expression and established immune gene signatures, and exploratory analysis linked progression-free survival to immune genes including CXCL9 and TAP1 and to PTEN alterations. The authors' conclusion is the honest one: the biology associated with checkpoint response is present in prostate cancer, in fewer men, and careful patient selection would be required for any of it to matter.\n\nKEYNOTE-641 (pembrolizumab with enzalutamide, 1,244 men), KEYNOTE-921 (pembrolizumab with docetaxel, 1,030 men) and KEYNOTE-991 (pembrolizumab with enzalutamide and androgen deprivation in hormone-sensitive disease, 1,251 men) all reached the same conclusion afterwards.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03016312","url":"https://clinicaltrials.gov/study/NCT03016312"},{"label":"IMbassador250 (Nature Medicine 2022)","url":"https://doi.org/10.1038/s41591-021-01600-6"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1","pten","androgen-receptor"],"drugs":["atezolizumab","enzalutamide"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["castration-resistance","arpi"],"trials":["keynote-641","keynote-921","keynote-991","ca184-043-ipilimumab"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03016312","phase":"3","setting":"Metastatic castration-resistant prostate cancer that had progressed on abiraterone: atezolizumab with enzalutamide against enzalutamide alone, open-label, with overall survival as the primary endpoint","sponsor":"Roche / Genentech","result":"Overall survival not improved: stratified hazard ratio 1.12 (95 percent confidence interval 0.91 to 1.37, p=0.28) for atezolizumab with enzalutamide against enzalutamide alone.","started":"2017-01-10","startedType":"actual","yearReported":2022,"enrolled":759,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"arms":[{"name":"Atezolizumab with enzalutamide","note":"Stratified hazard ratio; 759 men in total."},{"name":"Enzalutamide alone"}],"hr":1.12,"ci":[0.91,1.37],"p":"0.28","source":"https://doi.org/10.1038/s41591-021-01600-6"}],"replication":"KEYNOTE-641, KEYNOTE-921 and KEYNOTE-991 all failed in the same direction with pembrolizumab, and CA184-043 failed with ipilimumab."},{"id":"imblaze370","kind":"trial","name":"IMblaze370","aka":["COTEZO"],"tldr":"The trial that tried to make immunotherapy work in ordinary bowel cancer by adding a MEK inhibitor. It failed outright.","summary":"IMblaze370 randomised 363 patients 2:1:1 to atezolizumab with cobimetinib, atezolizumab alone, or regorafenib, after progression on at least two previous chemotherapy regimens. Median overall survival was 8.87 months with the combination, 7.10 months with atezolizumab alone and 8.51 months with regorafenib; the hazard ratio was 1.00 (95% CI 0.73 to 1.38, p=0.99) for the combination against regorafenib. Grade 3 to 4 adverse events affected 61 percent of the combination group. The preclinical rationale, that MEK inhibition raises MHC class I expression and drives T cells into tumours, did not translate. IMblaze370 is the reference failure for checkpoint inhibition in microsatellite-stable colorectal cancer and the reason later attempts focus on Fc-enhanced CTLA-4 blockade, on excluding patients with liver metastases, or on combining with targeted therapy.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02788279","url":"https://clinicaltrials.gov/study/NCT02788279"},{"label":"IMblaze370: atezolizumab with or without cobimetinib versus regorafenib in previously treated metastatic colorectal cancer (Lancet Oncology 2019)","url":"https://doi.org/10.1016/S1470-2045(19)30027-0"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":["pd1","mek"],"drugs":["atezolizumab","cobimetinib","regorafenib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["msi","cold-vs-hot"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02788279","phase":"3","setting":"Previously treated metastatic colorectal adenocarcinoma, mostly microsatellite-stable: atezolizumab with cobimetinib, or atezolizumab alone, against regorafenib","sponsor":"Hoffmann-La Roche","result":"Median overall survival 8.87 months with atezolizumab and cobimetinib against 8.51 months with regorafenib (hazard ratio 1.00).","started":"2016-07-05","startedType":"actual","yearReported":2019,"enrolled":363,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Atezolizumab and cobimetinib","n":183,"value":8.87},{"name":"Atezolizumab","n":90,"value":7.1},{"name":"Regorafenib","n":90,"value":8.51}],"hr":1,"ci":[0.73,1.38],"p":"0.99","source":"https://doi.org/10.1016/S1470-2045(19)30027-0"}]},{"id":"imbrave050","kind":"trial","name":"IMbrave050","aka":[],"tldr":"The first adjuvant immunotherapy trial in liver cancer looked positive early, then the benefit vanished with longer follow-up.","summary":"IMbrave050, trial NCT04102098 sponsored by Roche and reported in 2023, was the first adjuvant immunotherapy trial in liver cancer, and it looked positive early before the benefit vanished with longer follow-up. It randomised 668 patients to atezolizumab plus bevacizumab or active surveillance after resection or ablation of high-risk hepatocellular carcinoma, and an interim recurrence-free survival benefit prompted enthusiasm, but the updated analysis in 2026 showed the benefit was not sustained and did not support adjuvant use, with only a possible signal in subgroups. OnCo links it to hepatocellular carcinoma, atezolizumab and Ann-Lii Cheng. The record treats it as a lesson about immature interim analyses, and whether any adjuvant strategy can prevent recurrence in liver cancer remains open.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04102098","url":"https://clinicaltrials.gov/study/NCT04102098"},{"label":"Updated data (J Hepatol 2026)","url":"https://www.journal-of-hepatology.eu/article/S0168-8278(26)00017-6/fulltext"}],"tags":["failure","lesson:interim-analysis"],"related":[],"cancers":["hcc","hcc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ann-lii-cheng"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04102098","phase":"3","setting":"Adjuvant atezolizumab + bevacizumab vs active surveillance after resection or ablation of high-risk HCC","sponsor":"Roche","result":"Interim RFS HR 0.72; benefit not sustained at update.","started":"2019-12-31","startedType":"actual","yearReported":2023,"enrolled":668,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free survival (interim)","primary":true,"arms":[{"name":"Atezolizumab + bevacizumab","n":334},{"name":"Surveillance","n":334}],"hr":0.72,"ci":[0.56,0.93],"source":"https://doi.org/10.1016/S0140-6736(23)01796-8"}],"replication":"The updated analysis of the same trial did not confirm the interim result."},{"id":"imbrave150","kind":"trial","name":"IMbrave150","aka":[],"tldr":"The trial that ended the sorafenib era: immunotherapy plus an anti-VEGF antibody became the new first-line standard for liver cancer.","summary":"IMbrave150, trial NCT03434379 sponsored by Roche and reported in 2020, ended the sorafenib era by making atezolizumab plus bevacizumab the new first-line standard for unresectable hepatocellular carcinoma. It randomised 501 patients and met both primary endpoints of overall and progression-free survival, with a much higher response rate, becoming the first regimen to beat sorafenib on survival, though bevacizumab's bleeding risk means patients need endoscopy for varices first. OnCo links it to PD-L1 and VEGF as targets, atezolizumab, Richard S. Finn, Ann-Lii Cheng and Ho Yeong Lim, and to the caution pairing about bevacizumab with untreated varices; the result is consistent with the class effect seen in CARES-310 and ORIENT-32. Whether it remains the preferred first-line regimen against dual checkpoint blockade from HIMALAYA and CheckMate 9DW is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03434379","url":"https://clinicaltrials.gov/study/NCT03434379"},{"label":"IMbrave150 response characterisation","url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8366100/"}],"tags":[],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1","vegf"],"drugs":["atezolizumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["richard-finn","ann-lii-cheng","lim-ho-yeong"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03434379","phase":"3","setting":"First-line unresectable HCC: atezolizumab + bevacizumab vs sorafenib","sponsor":"Roche","result":"OS 19.2 vs 13.4 months, HR 0.66.","started":"2018-03-15","startedType":"actual","yearReported":2020,"enrolled":501,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (updated)","primary":true,"unit":"months","arms":[{"name":"Atezolizumab + bevacizumab","n":336,"value":19.2},{"name":"Sorafenib","n":165,"value":13.4}],"hr":0.66,"ci":[0.52,0.85],"source":"https://doi.org/10.1056/NEJMoa1915745"},{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Atezolizumab + bevacizumab","value":6.9},{"name":"Sorafenib","value":4.3}],"hr":0.65,"source":"https://doi.org/10.1056/NEJMoa1915745"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Atezolizumab + bevacizumab","value":30},{"name":"Sorafenib","value":11}],"source":"https://doi.org/10.1056/NEJMoa1915745"}],"replication":"Consistent with real-world cohorts and with the anti-VEGF + PD-(L)1 class effect seen in CARES-310 and ORIENT-32."},{"id":"imcgp100-202","kind":"trial","name":"IMCgp100-202","aka":[],"tldr":"The first drug ever to extend life in metastatic uveal melanoma, and the first T-cell receptor-based medicine to win a phase 3.","summary":"IMCgp100-202, trial NCT03070392 sponsored by Immunocore and reported in 2021, produced the first drug ever to extend life in metastatic uveal melanoma and the first T-cell receptor-based medicine to win a phase 3. It randomised 378 untreated HLA-A*02:01-positive patients to tebentafusp or investigator's choice of pembrolizumab, ipilimumab or dacarbazine and met its primary overall survival endpoint despite a low response rate, showing that circulating tumour DNA reduction and slowed growth matter more than RECIST shrinkage for this class; approval followed in January 2022, with cytokine release syndrome and rash manageable through step-up dosing. There is no second randomised trial, and whether the approach transfers to cutaneous melanoma, as PRISM-MEL-301 tests, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03070392","url":"https://clinicaltrials.gov/study/NCT03070392"},{"label":"NEJM 2021","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2103485"}],"tags":[],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["t-cell-engager"],"targets":["gp100","cd3"],"drugs":["tebentafusp"],"companies":["immunocore"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["paul-nathan","richard-carvajal"],"bottlenecks":[],"keyPapers":["paper-imcgp100-202-n-engl-j-med-2021","paper-imcgp100-202-n-engl-j-med-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03070392","phase":"2","setting":"Untreated HLA-A*02:01-positive metastatic uveal melanoma: tebentafusp vs investigator's choice (pembrolizumab, ipilimumab, or dacarbazine)","sponsor":"Immunocore","result":"OS 21.7 vs 16.0 months; HR 0.51.","started":"2017-10-16","startedType":"actual","yearReported":2021,"enrolled":378,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Tebentafusp","value":21.7},{"name":"Investigator's choice","value":16}],"hr":0.51,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2103485"}],"replication":"Supported by a phase 2 in previously treated uveal melanoma; no second randomised trial."},{"id":"imerge","kind":"trial","name":"IMerge","aka":[],"tldr":"IMerge showed that imetelstat, a drug that blocks telomerase in the abnormal blood-forming cells, freed many people with lower-risk myelodysplastic syndromes from transfusions for months or years after erythropoietin had failed.","summary":"IMerge enrolled patients with very low-, low- or intermediate-1 risk myelodysplastic syndromes who needed regular red cell transfusions, had relapsed after or were refractory to erythropoiesis-stimulating agents, and did not have a del(5q) abnormality. The phase 3 part randomised them two to one to imetelstat, an oligonucleotide that inhibits telomerase, or placebo, with red cell transfusion independence for at least eight weeks as the primary endpoint.\n\nImetelstat produced eight-week and 24-week transfusion independence in significantly more patients than placebo, with reductions in the mutant clone burden in some. Cytopenias were the main toxicity. The drug was approved in the United States in June 2024 for this population.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02598661","url":"https://clinicaltrials.gov/study/NCT02598661"}],"tags":["subtype-trials"],"related":[],"cancers":["mds-lower-risk","mds"],"sections":[],"technologies":["antisense-sirna"],"targets":[],"drugs":["imetelstat"],"companies":["geron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["uwe-platzbecker"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02598661","phase":"2/3","setting":"Transfusion-dependent lower-risk myelodysplastic syndromes without del(5q) after erythropoiesis-stimulating agents: the telomerase inhibitor imetelstat against placebo","sponsor":"Geron Corporation","result":"Imetelstat produced eight-week transfusion independence in significantly more patients than placebo; approved in June 2024.","started":"2016-01-12","startedType":"actual","yearReported":2023,"enrolled":289,"enrolledBasis":"registry","outcomes":[{"endpoint":"Red blood cell transfusion independence >=8 weeks","primary":true,"unit":"%","arms":[{"name":"Imetelstat 7.5 mg/kg","n":118,"value":40,"note":"Rate difference 25% (95% CI 9.9 to 36.9); median follow-up 19.5 months"},{"name":"Placebo","n":60,"value":15}],"p":"0.0008","source":"https://doi.org/10.1016/s0140-6736(23)01724-5"},{"endpoint":"Grade 3-4 neutropenia","unit":"%","arms":[{"name":"Imetelstat 7.5 mg/kg","n":118,"value":68},{"name":"Placebo","n":59,"value":3}],"source":"https://doi.org/10.1016/s0140-6736(23)01724-5"},{"endpoint":"Grade 3-4 thrombocytopenia","unit":"%","arms":[{"name":"Imetelstat 7.5 mg/kg","n":118,"value":62},{"name":"Placebo","n":59,"value":8}],"source":"https://doi.org/10.1016/s0140-6736(23)01724-5"}]},{"id":"imforte","kind":"trial","name":"IMforte","aka":[],"tldr":"IMforte produced the first maintenance treatment ever approved for extensive-stage small-cell lung cancer, adding lurbinectedin to the immunotherapy that continues after chemotherapy.","summary":"IMforte, trial NCT05091567 sponsored by Roche, Jazz and PharmaMar and reported at the ASCO 2025 plenary and in the Lancet in 2025, produced the first maintenance treatment ever approved for extensive-stage small-cell lung cancer, adding lurbinectedin to the atezolizumab that continues after chemotherapy. It randomised 483 patients without progression after four cycles of carboplatin, etoposide and atezolizumab to lurbinectedin plus atezolizumab or atezolizumab alone, met both primary endpoints of overall and progression-free survival, and led to FDA approval on 2 October 2025, at the cost of added myelosuppression and fatigue. The maintenance concept is now being tested with tarlatamab in DeLLphi-305, so which agent wins the maintenance slot is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05091567","url":"https://clinicaltrials.gov/study/NCT05091567"},{"label":"FDA approval (Oct 2025)","url":"https://www.roche.com/media/releases/med-cor-2025-10-03b"}],"tags":[],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["lurbinectedin","atezolizumab"],"companies":["jazz","pharmamar"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-imforte-lancet-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05091567","phase":"3","setting":"First-line maintenance after induction chemo-immunotherapy in ES-SCLC: lurbinectedin + atezolizumab vs atezolizumab","sponsor":"Roche / Jazz / PharmaMar","result":"OS 13.2 vs 10.6 months (HR 0.73); PFS HR 0.54.","started":"2021-11-18","startedType":"actual","yearReported":2025,"enrolled":483,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Lurbinectedin + atezolizumab","n":242,"value":13.2},{"name":"Atezolizumab","n":241,"value":10.6}],"hr":0.73,"ci":[0.57,0.95],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01011-6/abstract"},{"endpoint":"Progression-free survival (IRF)","primary":true,"unit":"months","arms":[{"name":"Lurbinectedin + atezolizumab","value":5.4},{"name":"Atezolizumab","value":2.1}],"hr":0.54,"ci":[0.43,0.67],"source":"https://doi.org/10.1016/S0140-6736(25)01011-6"}],"replication":"Single phase 3; the maintenance concept is being tested with tarlatamab (DeLLphi-305) and I-DXd."},{"id":"nct04086264","kind":"trial","name":"IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia","aka":[],"tldr":"A phase 1/2 trial of Azacitidine, Pivekimab sunirine and Venetoclax in acute myeloid leukaemia, run by AbbVie, active and no longer recruiting.","summary":"IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia is a phase 1/2 interventional study registered as NCT04086264 by AbbVie, with 218 participants enrolled, started 2019-11-06 and due to reach its primary completion in 2027-02. Interventions recorded: Azacitidine, IMGN632 and Venetoclax.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04086264","url":"https://clinicaltrials.gov/study/NCT04086264"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["adc","bcl2-inhibitors","cytotoxic-chemotherapy","epigenetic-drugs","kinase-inhibitors"],"targets":[],"drugs":["azacitidine","pivekimab-sunirine","venetoclax"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04086264","phase":"1/2","setting":"A Phase 1b/2 Study of IMGN632 as Monotherapy or Combination With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia","sponsor":"AbbVie","started":"2019-11-06","startedType":"actual","enrolled":218,"enrolledBasis":"registry","outcomes":[]},{"id":"immagine-1","kind":"trial","name":"iMMagine-1","aka":[],"tldr":"iMMagine-1 is the pivotal study behind anito-cel's BLA, with responses in nearly every patient.","summary":"iMMagine-1, trial NCT05396885 sponsored by Arcellx and Kite and reported in 2025, is the pivotal single-arm study behind the biologics licence application for anitocabtagene autoleucel, a BCMA CAR-T, in relapsed or refractory myeloma after at least four prior lines. In 117 patients the response rate was 97 percent with complete response or better in about 62 percent at about twelve months, no delayed neurotoxicity or parkinsonism was reported and cytokine release syndrome was mostly low grade; the application was accepted in February 2026 with a PDUFA date in December 2026. OnCo links it to multiple myeloma and anito-cel. Whether the absence of delayed neurotoxicity holds up with longer follow-up and larger numbers is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05396885","url":"https://clinicaltrials.gov/study/NCT05396885"}],"tags":[],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["anitocabtagene-autoleucel"],"companies":["arcellx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05396885","phase":"2","setting":"Relapsed/refractory myeloma after ≥4 lines: anito-cel single infusion","sponsor":"Arcellx / Kite","result":"ORR 97%.","started":"2022-07-15","startedType":"actual","yearReported":2025,"enrolled":117,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Anito-cel","n":117,"value":97}]}]},{"id":"nct07260058","kind":"trial","name":"Immune Cell Therapy for Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd., not yet recruiting.","summary":"Immune Cell Therapy for Advanced Solid Tumors is a phase 1/2, interventional study registered as NCT07260058 by Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd., with a registry enrolment figure of 48 participants, started 2025-12-01 and due to reach its primary completion in 2027-06-30. Interventions recorded: Autologous immune Cells; Standard chemotherapy. Conditions listed: Lung Cancer (Locally Advanced or Metastatic); Liver Cancer (Locally Advanced or Metastatic); Colorectal Cancer (Locally Advanced or Metastatic); Breast Cancer (Locally Advanced or Metastatic); Advanced Solid Tumors. Primary outcome: Phase II Primary Outcome: Objective Response Rate (ORR); Phase I Primary Outcome: Incidence of Adverse Events (AEs). Colorectal eligibility wording from the registry: \"Histologically and/or cytologically confirmed locally advanced or metastatic solid tumor: lung cancer, liver cancer, colorectal cancer, or breast cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07260058","url":"https://clinicaltrials.gov/study/NCT07260058"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07260058","phase":"1/2","setting":"Clinical Study on the Safety and Efficacy of Autologous Immune Cell Therapy for Advanced Solid Tumors","sponsor":"Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.","started":"2025-12-01","startedType":"estimated","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06154538","kind":"trial","name":"Immune Checkpoint Inhibitors + Chemotherapy Versus Chemotherapy in the Neoadjuvant Treatment of Locally Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"Immune Checkpoint Inhibitors + Chemotherapy Versus Chemotherapy in the Neoadjuvant Treatment of Locally Advanced Colorectal Cancer is a phase 2, randomised interventional study registered as NCT06154538 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 170 participants, started 2023-11-01 and due to reach its primary completion in 2026-11-01. Interventions recorded: Immune checkpoint inhibitor; FOLFOX regimen. Conditions listed: Locally Advanced Colorectal Carcinoma. Primary outcome: pCR rate. Colorectal eligibility wording from the registry: \"* Histologically or cytologically confirmed colorectal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06154538","url":"https://clinicaltrials.gov/study/NCT06154538"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06154538","phase":"2","setting":"Comparison of Immune Checkpint Inhibitors Combined With Chemotherapy Versus Chemotherapy Alone in the Neoadjuvant Treatment of Locally Advanced Colorectal Cancer: a Randomized, Open-label, Single-center Phase II Clinical Study","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2023-11-01","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06580574","kind":"trial","name":"Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Peking University, now recruiting.","summary":"Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers is a phase 2, interventional study registered as NCT06580574 by Peking University, with a registry enrolment figure of 34 participants, started 2024-09-13 and due to reach its primary completion in 2029-06-01. Interventions recorded: PD1/PDL1 antibody monotherapy, up to 24 weeks; Intensive immunotherapy plus anti-VEGF treatment, up to 24 weeks; Radical surgery. Conditions listed: Gastric Cancer; Colon Cancer; MSI-H; DMMR Cancer. Primary outcome: Organ preservation rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed gastric cancer or colon cancer, without distant metastasis based on CR or MR\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06580574","url":"https://clinicaltrials.gov/study/NCT06580574"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06580574","phase":"2","setting":"PD-1/PD-L1 Antibody With Selective Combination of Sintilimab, IBI310 and Lenvatinib Used for Organ Preservation in Non-metastatic Gastric or Colon Cancers With Mismatch Repair Deficiency or High Microsatellite Instability","sponsor":"Peking University","started":"2024-09-13","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04159818","kind":"trial","name":"Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients","aka":["TONIC-2"],"tldr":"A phase 2 trial of nivolumab and cisplatin in triple-negative breast cancer, run by The Netherlands Cancer Institute, now recruiting.","summary":"Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients is a phase 2, randomised interventional study registered as NCT04159818 by The Netherlands Cancer Institute, with a registry enrolment figure of 52 participants, started 2020-02-21 and due to reach its primary completion in 2022-12-15. Interventions recorded: Nivolumab; Cisplatin; Low dose doxorubicin. Conditions listed: Metastatic Breast Cancer. Triple-negative eligibility wording from the registry: \"* Metastatic or incurable locally advanced triple negative breast cancer (ER \\< 10%, HER2 IHC 0,1+ or 2+ with no amplification)\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04159818","url":"https://clinicaltrials.gov/study/NCT04159818"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["nivolumab","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04159818","phase":"2","setting":"Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients: the TONIC-2 Trial","sponsor":"The Netherlands Cancer Institute","started":"2020-02-21","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07011823","kind":"trial","name":"Immune-checkpoint Blockade After Partial Breast Irradiation by Pembrolizumab in Early TNBC","aka":["KEY-MELT"],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Gangnam Severance Hospital, not yet recruiting.","summary":"Immune-checkpoint Blockade After Partial Breast Irradiation by Pembrolizumab in Early TNBC is a phase 2, interventional study registered as NCT07011823 by Gangnam Severance Hospital, with a registry enrolment figure of 20 participants, started 2025-07-16 and due to reach its primary completion in 2027-07-31. Interventions recorded: Partial breast-irradiation. Conditions listed: Triple-Negative Breast Neoplasm. Triple-negative eligibility wording from the registry: \"* Patients with triple-negative breast cancer confirmed on tissue biopsy\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07011823","url":"https://clinicaltrials.gov/study/NCT07011823"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07011823","phase":"2","setting":"Phase II Trial of Immunochemotherapy and Partial Breast Irradiation in Early TNBC With Immune-cold Tumor Environment (KEY-MELT)","sponsor":"Gangnam Severance Hospital","started":"2025-07-16","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05909436","kind":"trial","name":"Immuno-Oncology Drugs GLS-012 Alone & in Combination GLS-010 Treating With Advanced Patients Solid Tumors","aka":["Triumph-01"],"tldr":"A phase 1/2 trial of Zimberelimab in advanced solid tumours, run by Guangzhou Gloria Biosciences Co., Ltd., now recruiting.","summary":"Immuno-Oncology Drugs GLS-012 Alone & in Combination GLS-010 Treating With Advanced Patients Solid Tumors is a phase 1/2 interventional study registered as NCT05909436 by Guangzhou Gloria Biosciences Co., Ltd., with 107 participants planned, started 2022-10-31 and due to reach its primary completion in 2026-12. Interventions recorded: GLS-012 and GLS-010.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05909436","url":"https://clinicaltrials.gov/study/NCT05909436"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["zimberelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05909436","phase":"1/2","setting":"A Phase I/II Study Evaluating the Safety, Tolerability and Preliminary Efficacy of GLS-012 Monotherapy and in Combination With GLS-010 in Patients With Advanced Solid Tumors After Progression on Standard Treatment (Triumph-01)","sponsor":"Guangzhou Gloria Biosciences Co., Ltd.","started":"2022-10-31","startedType":"actual","enrolled":107,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05027776","kind":"trial","name":"Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years","aka":[],"tldr":"A phase 3 trial of 2-doses Group among 9-14 years in cervical cancer and vaginal cancer, run by Shanghai Bovax Biotechnology Co., Ltd., now recruiting.","summary":"Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years is a phase 3 interventional study registered as NCT05027776 by Shanghai Bovax Biotechnology Co., Ltd., with 1348 participants planned, started 2021-09-15 and due to reach its primary completion in 2023-11-22. Interventions recorded: 2-doses Group among 9-14 years, 3-doses Group among 9-19 years and 3-doses Group among 20-26 years.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05027776","url":"https://clinicaltrials.gov/study/NCT05027776"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cervical","vaginal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shanghai-bovax-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05027776","phase":"3","setting":"Evaluating the Immunogenicity and Safety of Quadrivalent Human Papillomavirus Recombinant Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 26 Years: A Phase 3, Open-label, Non-randomized Clinical Trial","sponsor":"Shanghai Bovax Biotechnology Co., Ltd.","started":"2021-09-15","startedType":"actual","enrolled":1348,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06840704","kind":"trial","name":"Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer","aka":["Relief"],"tldr":"A phase 3 trial in lung cancer, run by Hunan Cancer Hospital, now recruiting.","summary":"Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer is a phase 3, randomised interventional study registered as NCT06840704 by Hunan Cancer Hospital, with a registry enrolment figure of 121 participants, started 2025-02-25 and due to reach its primary completion in 2026-06-30. Interventions recorded: Oral immunonutrition. Conditions listed: Non Small Cell Lung Cancer; Small Cell Lung Cancer. Primary outcome: Incidence rate of grade 2 or higher acute esophagitis. Lung eligibility wording from the registry: \"Pathologically confirmed diagnosis of lung cancer, including non-small cell lung cancer and small cell lung cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06840704","url":"https://clinicaltrials.gov/study/NCT06840704"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc","nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06840704","phase":"3","setting":"Immunonutrition in Reducing Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer: a Prospective, Randomized, Controlled, Open-label Clinical Trial","sponsor":"Hunan Cancer Hospital","started":"2025-02-25","startedType":"actual","enrolled":121,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07140679","kind":"trial","name":"Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer","aka":[],"tldr":"A phase 2 trial of toripalimab in colorectal cancer, run by Emory University, now recruiting.","summary":"Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer is a phase 2, interventional study registered as NCT07140679 by Emory University, with a registry enrolment figure of 40 participants, started 2025-09-19 and due to reach its primary completion in 2029-09-30. Interventions recorded: Biopsy Procedure; Biospecimen Collection; Colonoscopy; Computed Tomography; Questionnaire Administration; Toripalimab. Conditions listed: Localized Colon Carcinoma; Stage IIB Colon Cancer AJCC v8; Stage IIC Colon Cancer AJCC v8; Stage III Colon Cancer AJCC v8. Primary outcome: 3-year Disease free survival (DFS). Colorectal eligibility wording from the registry: \"* Patients with resected pathologic stage IIB, IIC and III dMMR colon cancer (American Joint Committee on Cancer \\[AJCC\\] 8)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07140679","url":"https://clinicaltrials.gov/study/NCT07140679"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":["coherus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07140679","phase":"2","setting":"A Phase II Trial of Adjuvant Toripalimab in High Risk Localized Colon Cancer With Mismatch Repair Deficiency","sponsor":"Emory University","started":"2025-09-19","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06498635","kind":"trial","name":"Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial","aka":[],"tldr":"A phase 3 trial of durvalumab in lung cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial is a phase 3, randomised interventional study registered as NCT06498635 by National Cancer Institute (NCI), with a registry enrolment figure of 306 participants, started 2025-04-01 and due to reach its primary completion in 2039-07-15. Interventions recorded: Biospecimen Collection; Computed Tomography; Durvalumab; Patient Observation; Questionnaire Administration. Conditions listed: Lung Non-Small Cell Carcinoma; Stage II Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8. Primary outcome: Disease-free survival (DFS). Lung eligibility wording from the registry: \"* Participants must have histologically or cytological confirmed diagnosis of clinical stage II-IIIB (excluding clinical N3 disease) non-small cell lung cancer (NSCLC)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06498635","url":"https://clinicaltrials.gov/study/NCT06498635"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06498635","phase":"3","setting":"Randomized Phase III Trial INcorporating Pathologic Complete ReSponse in Participants With Early StaGe Non Small Cell Lung Cancer to Optimize ImmunotHerapy in The AdjuvanT Setting (INSIGHT)","sponsor":"National Cancer Institute (NCI)","started":"2025-04-01","startedType":"actual","enrolled":306,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04238637","kind":"trial","name":"Immunotherapy Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC)","aka":[],"tldr":"A phase 2 trial of durvalumab and tremelimumab in gallbladder cancer and other biliary tract cancers, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, active and no longer recruiting.","summary":"Immunotherapy Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC) is a phase 2, randomised interventional study registered as NCT04238637 by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, with a registry enrolment figure of 50 participants, started 2019-11-01 and due to reach its primary completion in 2026-08. Interventions recorded: Durvalumab, Tremelimumab. Conditions listed: Intrahepatic Cholangiocarcinoma. Sites: Germany. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04238637","url":"https://clinicaltrials.gov/study/NCT04238637"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04238637","phase":"2","setting":"Phase II Study of Immunotherapy With Durvalumab (MEDI4736) or Durvalumab and Tremelimumab, Both Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC)","sponsor":"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest","started":"2019-11-01","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05732389","kind":"trial","name":"Immunotherapy in Patients With Early dMMR Rectal Cancer","aka":["RESET-R"],"tldr":"A phase 2 trial of nivolumab and ipilimumab in colorectal cancer, run by Odense University Hospital, now recruiting.","summary":"Immunotherapy in Patients With Early dMMR Rectal Cancer is a phase 2, interventional study registered as NCT05732389 by Odense University Hospital, with a registry enrolment figure of 39 participants, started 2023-02-01 and due to reach its primary completion in 2027-07. Interventions recorded: Nivolumab; Ipilimumab. Conditions listed: Cancer of Rectum. Primary outcome: Complete clinical response. Colorectal eligibility wording from the registry: \"* Histologically verified non-metastatic rectal cancer stage 1-3\". Sites: Denmark. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05732389","url":"https://clinicaltrials.gov/study/NCT05732389"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05732389","phase":"2","setting":"Immunotherapy in Patients With Early dMMR Rectal Cancer","sponsor":"Odense University Hospital","started":"2023-02-01","startedType":"actual","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05522660","kind":"trial","name":"Immunotherapy or Targeted Therapy With or Without Stereotactic Radiosurgery for Patients With Brain Metastases From Melanoma or Non-small Cell Lung Cancer","aka":["USZ-STRIKE"],"tldr":"A phase 3 trial in lung cancer, run by ETOP IBCSG Partners Foundation, now recruiting.","summary":"Immunotherapy or Targeted Therapy With or Without Stereotactic Radiosurgery for Patients With Brain Metastases From Melanoma or Non-small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT05522660 by ETOP IBCSG Partners Foundation, with a registry enrolment figure of 180 participants, started 2022-11-30 and due to reach its primary completion in 2026-09. Interventions recorded: Stereotactic radiosurgery; Immune checkpoint inhibitor. Conditions listed: Non-Small Cell Lung Cancer; Melanoma. Primary outcome: CNS-specific PFS, locally assessed as per iRANO criteria. Lung eligibility wording from the registry: \"* Primary disease of histologically confirmed (from primary tumour or from a metastatic lesion, including in the brain) melanoma or NSCLC\". Sites: Italy, Netherlands, Spain, Switzerland, United Kingdom. United Kingdom sites listed: 2. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05522660","url":"https://clinicaltrials.gov/study/NCT05522660"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":["etop-ibcsg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Royal Marsden (Sutton) (London); Christie NHS Manchester (Manchester)."],"nct":"NCT05522660","phase":"3","setting":"A Multicentre Randomised Open-label Phase III Study of Stereotactic Radiosurgery, in Addition to Standard Systemic Therapy for Patients With Metastatic Melanoma or Newly Diagnosed Metastatic NSCLC and Asymptomatic or Oligo-symptomatic Brain Metastases","sponsor":"ETOP IBCSG Partners Foundation","started":"2022-11-30","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01174121","kind":"trial","name":"Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer","aka":[],"tldr":"A phase 2 trial of pembrolizumab, fludarabine, cyclophosphamide and aldesleukin (high-dose IL-2) in colorectal cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer is a phase 2, interventional study registered as NCT01174121 by National Cancer Institute (NCI), with a registry enrolment figure of 332 participants, started 2010-08-26 and due to reach its primary completion in 2028-12-27. Interventions recorded: Pembrolizumab (Keytruda); Fludarabine; Cyclophosphamide; Aldesleukin; Young TIL. Conditions listed: Metastatic Colorectal Cancer; Metastatic Pancreatic Cancer; Metastatic Ovarian Cancer; Metastatic Breast Carcinoma; Metastatic Endocrine Tumors/ Neuroendocrine Tumors. Primary outcome: Response rate. Colorectal eligibility wording from the registry: \"* Patients with metastatic colorectal cancer must have received oxaliplatin or irinotecan\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01174121","url":"https://clinicaltrials.gov/study/NCT01174121"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["pembrolizumab","fludarabine","cyclophosphamide","aldesleukin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01174121","phase":"2","setting":"A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphodepleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab","sponsor":"National Cancer Institute (NCI)","started":"2010-08-26","startedType":"actual","enrolled":332,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07718490","kind":"trial","name":"Immunotheray Combined With Simvastatin and Target Therapy and Chemotharepy for Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of adebrelimab in colorectal cancer, run by The First Affiliated Hospital with Nanjing Medical University, now recruiting.","summary":"Immunotheray Combined With Simvastatin and Target Therapy and Chemotharepy for Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT07718490 by The First Affiliated Hospital with Nanjing Medical University, with a registry enrolment figure of 43 participants, started 2025-09-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: Adebrelimab. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Investigator-assessed Objective Response Rate（ORR）. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed metastatic colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07718490","url":"https://clinicaltrials.gov/study/NCT07718490"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07718490","phase":"2","setting":"A Multicenter, Prospective, Phase II Exploratory Study on the First-line Treatment of MSS/ PMMR-type Advanced Colorectal Cancer With Adebrelimab Combined With Simvastatin and Targeted and Chemotherapy","sponsor":"The First Affiliated Hospital with Nanjing Medical University","started":"2025-09-01","startedType":"actual","enrolled":43,"enrolledBasis":"registry","outcomes":[]},{"id":"impact-bcc","kind":"trial","name":"IMPACT (cemiplimab in advanced basal cell carcinoma)","aka":["ISRCTN10511385"],"tldr":"The British trial testing whether the immunotherapy that works for advanced squamous cell carcinoma also works, first line, for the advanced basal cell carcinomas NICE refused to fund a hedgehog inhibitor for.","summary":"Advanced basal cell carcinoma is the gap in the English funding table: NICE refused vismodegib in TA489, sonidegib has never been appraised at all, and what NHS England does fund through the national list is vismodegib for multiple operable lesions rather than for locally advanced disease. IMPACT asks whether first-line cemiplimab, already funded for advanced cutaneous squamous cell carcinoma under TA802, is an answer for this group. It is sponsored by University Hospitals Bristol and Weston with a target of 41 participants and a registered end date of 30 April 2029.","status":"active","asOf":"2026-09-25","links":[{"label":"ISRCTN10511385","url":"https://www.isrctn.com/ISRCTN10511385"}],"tags":["uk","skin","basal-cell-carcinoma","recruiting"],"related":[],"cancers":["basal-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["cemiplimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN10511385","phase":"2","setting":"UK phase 2 trial of three-weekly cemiplimab as first-line treatment for locally advanced basal cell carcinoma; registered end date 30 April 2029","sponsor":"University Hospitals Bristol and Weston NHS Foundation Trust","enrolled":41,"enrolledBasis":"registry","outcomes":[]},{"id":"impact-sipuleucel-t","kind":"trial","name":"IMPACT (sipuleucel-T)","aka":["IMPACT","D9902B","Immunotherapy for Prostate Adenocarcinoma Treatment"],"tldr":"The first cancer vaccine ever approved anywhere. It extended life by about four months without shrinking a single tumour, and the company that made it went bankrupt.","summary":"IMPACT randomised 512 men with metastatic castration-resistant prostate cancer 2:1 to sipuleucel-T (341) or placebo (171), given intravenously every 2 weeks for three infusions. The primary endpoint was overall survival, analysed by a stratified Cox model adjusted for baseline PSA and lactate dehydrogenase.\n\nSipuleucel-T reduced the risk of death by 22 percent, hazard ratio 0.78 (95 percent confidence interval 0.61 to 0.98, p=0.03), a 4.1-month gain in median survival (25.8 against 21.7 months). Thirty-six-month survival was 31.7 against 23.0 percent. The result held in an unadjusted model (0.77, 0.61 to 0.97, p=0.02) and after adjusting for later docetaxel use (0.78, 0.62 to 0.98, p=0.03).\n\nThe time to objective disease progression was the same in both groups. Nothing shrank. That dissociation, longer life without tumour response, is the finding that taught oncology that immunotherapy does not have to shrink a tumour to work, and it was the reason the field developed immune-related response criteria before checkpoint inhibitors arrived. Chills, fever and headache were the characteristic adverse events.\n\nThe commercial story is the cautionary one. The product required leukapheresis and a manufacturing turnaround for each man, was very expensive, and never sold in the volumes needed. Dendreon filed for bankruptcy in 2014. In England NICE TA332 on sipuleucel-T has been withdrawn because the marketing authorisation was withdrawn, so it is not available at all.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00065442","url":"https://clinicaltrials.gov/study/NCT00065442"},{"label":"IMPACT (New England Journal of Medicine 2010)","url":"https://doi.org/10.1056/NEJMoa1001294"},{"label":"NICE TA332: sipuleucel-T for asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer, guidance withdrawn because the marketing authorisation was withdrawn","url":"https://www.nice.org.uk/guidance/ta332"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["dendritic-cell-vaccines","checkpoint-inhibitor"],"targets":[],"drugs":["sipuleucel-t"],"companies":["dendreon"],"institutions":[],"pathways":[],"terms":["castration-resistance"],"trials":["prospect-prostvac","ca184-043-ipilimumab"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00065442","phase":"3","setting":"Metastatic castration-resistant prostate cancer: sipuleucel-T, an autologous cellular immunotherapy made from the man's own antigen-presenting cells loaded with a prostatic acid phosphatase fusion protein, against placebo, three infusions two weeks apart, randomised 2:1, with overall survival as the primary endpoint","sponsor":"Dendreon","result":"Median overall survival 25.8 against 21.7 months (hazard ratio 0.78, 95 percent confidence interval 0.61 to 0.98, p=0.03) with no difference in time to objective disease progression.","started":"2003-07","yearReported":2010,"enrolled":512,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Sipuleucel-T","n":341,"value":25.8},{"name":"Placebo","n":171,"value":21.7}],"hr":0.78,"ci":[0.61,0.98],"p":"0.03","source":"https://doi.org/10.1056/NEJMoa1001294"},{"endpoint":"Survival at 36 months","unit":"%","arms":[{"name":"Sipuleucel-T","n":341,"value":31.7},{"name":"Placebo","n":171,"value":23}],"source":"https://doi.org/10.1056/NEJMoa1001294"}],"replication":"No independent randomised replication; PROSTVAC, the other prostate cancer vaccine taken to phase 3, failed outright in PROSPECT."},{"id":"nct06999512","kind":"trial","name":"Impact of Comprehensive Geriatric Management on Morbidity and Quality of Life in Elderly Patients Undergoing Major Hepatectomy and Pancreaticoduodenectomy for C","aka":["HPB70+"],"tldr":"A phase 2/3 trial in pancreatic cancer, run by Assistance Publique - Hôpitaux de Paris, not yet recruiting.","summary":"Impact of Comprehensive Geriatric Management on Morbidity and Quality of Life in Elderly Patients Undergoing Major Hepatectomy and Pancreaticoduodenectomy for Cancer is a phase 2/3, randomised interventional study registered as NCT06999512 by Assistance Publique - Hôpitaux de Paris, with a registry enrolment figure of 526 participants, started 2025-09 and due to reach its primary completion in 2030-04. Interventions recorded: Comprehensive Geriatric Assessment. Conditions listed: Hepatobiliary Cancer; Pancreatic Cancer. Primary outcome: Comprehensive Complex Index (CCI) value. Pancreatic eligibility wording from the registry: \"* pancreatic adenocarcinoma\". Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06999512","url":"https://clinicaltrials.gov/study/NCT06999512"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06999512","phase":"2/3","setting":"Impact of Comprehensive Geriatric Management on Morbidity and Quality of Life in Elderly Patients Undergoing Major Hepatectomy and Pancreaticoduodenectomy for Cancer. A Randomized Controlled Trial.","sponsor":"Assistance Publique - Hôpitaux de Paris","started":"2025-09","startedType":"estimated","enrolled":526,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04677816","kind":"trial","name":"Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Wake Forest University Health Sciences, now recruiting.","summary":"Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients is a phase 2, interventional study registered as NCT04677816 by Wake Forest University Health Sciences, with a registry enrolment figure of 50 participants, started 2021-10-22 and due to reach its primary completion in 2026-12. Interventions recorded: Standard of Care Neoadjuvant Chemotherapy (NAC); Vitamin D3; Drug Diary. Conditions listed: Triple Negative Breast Cancer; Vitamin D Deficiency; Invasive Breast Cancer. Triple-negative eligibility wording from the registry: \"* Known triple negative ER/PR/HER2 receptor status as defined by:\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04677816","url":"https://clinicaltrials.gov/study/NCT04677816"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04677816","phase":"2","setting":"Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients Receiving Neoadjuvant Chemotherapy for Operable Triple Negative Breast Cancer","sponsor":"Wake Forest University Health Sciences","started":"2021-10-22","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"impactmf","kind":"trial","name":"IMpactMF","aka":["MYF3001"],"tldr":"IMpactMF is the first myelofibrosis trial designed to prove that a drug helps people live longer rather than just shrinking the spleen; it compares the telomerase blocker imetelstat with the best treatment doctors can otherwise offer after a JAK inhibitor has stopped working, and results are expected towards 2028.","summary":"IMpactMF is Geron's open-label randomised phase 3 trial in patients with intermediate-2 or high-risk myelofibrosis whose disease has relapsed after or is refractory to a JAK inhibitor. Patients are randomised two to one to imetelstat, an oligonucleotide inhibitor of telomerase, or best available therapy excluding JAK inhibitors. Unusually for myelofibrosis, the primary endpoint is overall survival, following the phase 2 IMbark study in which imetelstat was associated with longer survival than expected in this population.\n\nThe registry lists 327 participants enrolled with a primary completion date of June 2028 and no results. Imetelstat is approved for lower-risk myelodysplastic syndrome with transfusion-dependent anaemia; the corpus's primary myelofibrosis page cites IMpactMF as the trial testing it after JAK inhibitor failure.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04576156","url":"https://clinicaltrials.gov/study/NCT04576156"}],"tags":["soc-trials"],"related":[],"cancers":["primary-myelofibrosis","myeloproliferative-neoplasms"],"sections":[],"technologies":["kinase-inhibitors","antisense-sirna"],"targets":[],"drugs":["imetelstat"],"companies":["geron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04576156","phase":"3","setting":"Intermediate-2 or high-risk myelofibrosis relapsed or refractory to a JAK inhibitor: the telomerase inhibitor imetelstat against best available therapy, with overall survival as the primary endpoint","sponsor":"Geron Corporation","started":"2021-04-12","startedType":"actual","enrolled":327,"enrolledBasis":"registry","outcomes":[]},{"id":"impassion031","kind":"trial","name":"IMpassion031","aka":[],"tldr":"IMpassion031 showed that adding the immune drug atezolizumab to chemotherapy before surgery for early triple-negative breast cancer raised the share of women whose tumour had disappeared at surgery from 41 to 58 percent, whatever their PD-L1 status.","summary":"IMpassion031, trial NCT03197935 sponsored by Roche and Genentech and published in the Lancet in 2020, randomised 333 patients with previously untreated stage II or III triple-negative breast cancer to atezolizumab or placebo with nab-paclitaxel followed by doxorubicin and cyclophosphamide before surgery, with atezolizumab or observation after. Pathological complete response rose from 41 to 58 percent in all patients and from 49 to 69 percent in the PD-L1-positive subgroup, meeting the co-primary endpoint in the whole population but not the PD-L1-positive one at the prespecified boundary, with immune-related side effects as expected. It confirmed the KEYNOTE-522 finding that immunotherapy raises response rates in early disease regardless of PD-L1, but with no event-free survival benefit shown and the withdrawal of atezolizumab from metastatic breast cancer in 2021, pembrolizumab rather than atezolizumab became the standard. Whether the platinum-free backbone or the drug explains the smaller trial's limited uptake is a matter of debate.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03197935","url":"https://clinicaltrials.gov/study/NCT03197935"},{"label":"Mittendorf et al., IMpassion031 (Lancet 2020)","url":"https://doi.org/10.1016/S0140-6736(20)31953-X"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1"],"drugs":["atezolizumab","paclitaxel","doxorubicin","cyclophosphamide"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["pcr"],"trials":["neotrip","gepardouze","impassion030"],"people":["elizabeth-mittendorf"],"bottlenecks":[],"keyPapers":["paper-impassion031-lancet-2020","paper-impassion031-nat-med-2025-update"],"journals":[],"dependsOn":[],"notes":["Context from the other atezolizumab trials in early triple-negative disease: NeoTRIP (pathological complete response 48.6 versus 44.4 percent, not significant), GeparDouze/NSABP B-59 (event-free survival hazard ratio 0.80, p 0.083, not significant) and ALEXANDRA/IMpassion030 (adjuvant, invasive disease-free survival hazard ratio 1.11, stopped for futility) mean IMpassion031's pathological complete response gain has no survival confirmation, and atezolizumab has no early-stage indication anywhere."],"nct":"NCT03197935","phase":"3","setting":"Early triple-negative breast cancer (tumours over 2 cm): neoadjuvant atezolizumab or placebo with nab-paclitaxel then doxorubicin and cyclophosphamide","sponsor":"Roche / Genentech","result":"Pathological complete response 58% vs 41% (all patients); 69% vs 49% in PD-L1-positive disease.","started":"2017-07-24","startedType":"actual","yearReported":2020,"enrolled":333,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathological complete response (all patients)","primary":true,"unit":"%","arms":[{"name":"Atezolizumab + chemotherapy","n":165,"value":58},{"name":"Placebo + chemotherapy","n":168,"value":41}],"p":"0.0044","source":"https://doi.org/10.1016/S0140-6736(20)31953-X"}],"replication":"Consistent with KEYNOTE-522 on pathological complete response; event-free survival benefit not demonstrated."},{"id":"impassion130","kind":"trial","name":"IMpassion130","aka":[],"tldr":"IMpassion130 was the first immunotherapy success in breast cancer, later undermined when a sister trial failed and the approval was withdrawn.","summary":"IMpassion130, trial NCT02425891 sponsored by Roche and reported in 2018, was the first immunotherapy success in breast cancer, adding atezolizumab to nab-paclitaxel in first-line metastatic triple-negative breast cancer, and it was later undermined when a sister trial failed and the approval was withdrawn. It randomised 902 patients, met its primary progression-free survival endpoint in PD-L1-positive patients by the SP142 assay, and showed a survival difference in that group that was not formally tested under the hierarchical design, but IMpassion131 with paclitaxel was negative and the US approval was withdrawn in 2021. The record treats it as a lesson in chemotherapy partner and biomarker assay choice, and why the two trials diverged is the open question.","status":"mixed","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT02425891","url":"https://clinicaltrials.gov/study/NCT02425891"},{"label":"IMpassion130 primary analysis (NEJM 2018)","url":"https://doi.org/10.1056/NEJMoa1809615"},{"label":"IMpassion130 final overall survival (Annals of Oncology 2021)","url":"https://doi.org/10.1016/j.annonc.2021.05.355"},{"label":"NICE TA639 (1 July 2020)","url":"https://www.nice.org.uk/guidance/ta639"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab","paclitaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":["impassion131","keynote-355","neotrip"],"people":["rebecca-dent","peter-schmid"],"bottlenecks":[],"keyPapers":["paper-rugo-pd-l1-assay-comparison-impassion130-jnci-2021","paper-impassion130-n-engl-j-med-2018","paper-impassion130-lancet-oncol-2020-update"],"journals":[],"dependsOn":[],"notes":["Design (NEJM 2018): 902 untreated metastatic patients randomised 1 to 1 to atezolizumab 840 mg or placebo with nab-paclitaxel 100 mg/m2, stratified by PD-L1 on immune cells (SP142). Final overall survival (Annals of Oncology 2021): intention-to-treat 21.0 versus 18.7 months (hazard ratio 0.87, p 0.077, not significant, so the PD-L1-positive group could not be formally tested); PD-L1-positive 25.4 versus 17.9 months (0.67) as an exploratory finding; immune-mediated adverse events of special interest 58.7 versus 41.6 percent. Regulatory result: US accelerated approval March 2019, withdrawn August 2021 after IMpassion131; EU licence and NICE TA639 (1 July 2020) remain.","UK sites (registry, 10): Velindre Cardiff, Western General Edinburgh, St Bartholomew's, Guy's and St Thomas', Royal Marsden London and Sutton, the Christie, Derriford Plymouth, Royal Preston, Weston Park Sheffield."],"nct":"NCT02425891","phase":"3","setting":"First-line metastatic TNBC: atezolizumab + nab-paclitaxel","sponsor":"Roche","result":"PFS HR 0.62 in PD-L1+; approval withdrawn 2021 (US).","started":"2015-06-23","startedType":"actual","yearReported":2018,"enrolled":902,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival, PD-L1+ (SP142 IC ≥1%)","primary":true,"unit":"months","arms":[{"name":"Atezolizumab + nab-paclitaxel","n":185,"value":7.5},{"name":"Placebo + nab-paclitaxel","n":184,"value":5}],"hr":0.62,"ci":[0.49,0.78],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1809615"},{"endpoint":"Overall survival, PD-L1+","unit":"months","arms":[{"name":"Atezolizumab + nab-paclitaxel","value":25.4,"note":"Not formally tested under the hierarchical design"},{"name":"Placebo + nab-paclitaxel","value":17.9}],"hr":0.67,"ci":[0.53,0.86],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30689-8/fulltext"},{"endpoint":"Overall survival, ITT","unit":"months","arms":[{"name":"Atezolizumab + nab-paclitaxel","value":21,"note":"Not significant"},{"name":"Placebo + nab-paclitaxel","value":18.7}],"hr":0.87,"ci":[0.75,1.02],"source":"https://doi.org/10.1056/NEJMoa1809615"}],"replication":"Not replicated: IMpassion131 with paclitaxel was negative, leading to US withdrawal in 2021. KEYNOTE-355 confirmed the broader concept of chemo-immunotherapy in PD-L1-high disease."},{"id":"impassion131","kind":"trial","name":"IMpassion131","aka":[],"tldr":"IMpassion131 was the sister trial to the first immunotherapy success in breast cancer. It failed, and the approval it was meant to confirm was withdrawn.","summary":"IMpassion130 (nab-paclitaxel partner) had shown a PFS benefit in PD-L1-positive metastatic TNBC and won accelerated approval in 2019. IMpassion131 used conventional paclitaxel (which requires steroid premedication) and showed no PFS or OS benefit; OS trended worse in the atezolizumab arm. Roche withdrew the US TNBC indication in 2021. Pembrolizumab with chemotherapy (KEYNOTE-355) became the standard instead.\n\nLesson: the chemotherapy partner (steroid premedication, immunogenic cell death profile) and the PD-L1 assay (SP142 vs 22C3) can decide an immunotherapy trial; confirmatory trials must replicate the winning design.","status":"negative","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT03125902","url":"https://clinicaltrials.gov/study/NCT03125902"},{"label":"Annals of Oncology 2021","url":"https://www.annalsofoncology.org/article/S0923-7534(21)02073-7/fulltext"},{"label":"IMpassion131 primary results (Annals of Oncology 2021)","url":"https://doi.org/10.1016/j.annonc.2021.05.801"}],"tags":["failure","lesson:partner-and-biomarker"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab","paclitaxel","pembrolizumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["cps","accelerated-approval"],"trials":["impassion130","keynote-355"],"people":[],"bottlenecks":[],"keyPapers":["paper-impassion131-ann-oncol-2021"],"journals":[],"dependsOn":[],"notes":["Primary results (Annals of Oncology 2021): 651 patients randomised 2 to 1 to atezolizumab or placebo with paclitaxel 90 mg/m2; 45 percent PD-L1-positive. Investigator-assessed progression-free survival in the PD-L1-positive population 6.0 versus 5.7 months (hazard ratio 0.82, p 0.20); final overall survival 22.1 versus 28.3 months (hazard ratio 1.11, 0.76 to 1.64). Three UK sites (Guy's, the Christie, Mount Vernon)."],"nct":"NCT03125902","phase":"3","setting":"First-line metastatic TNBC: atezolizumab + paclitaxel vs paclitaxel","sponsor":"Roche","result":"PFS HR 0.82 (not significant); OS trend unfavourable; US indication withdrawn 2021.","started":"2017-08-25","startedType":"actual","yearReported":2020,"enrolled":653,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival, PD-L1+ (investigator)","primary":true,"unit":"months","arms":[{"name":"Atezolizumab + paclitaxel","n":191,"value":6,"note":"Not significant"},{"name":"Placebo + paclitaxel","n":101,"value":5.7}],"hr":0.82,"ci":[0.6,1.12],"p":"0.20","source":"https://www.annalsofoncology.org/article/S0923-7534(21)02012-3/fulltext"},{"endpoint":"Overall survival, PD-L1+","unit":"months","arms":[{"name":"Atezolizumab + paclitaxel","value":22.1,"note":"Numerically unfavourable"},{"name":"Placebo + paclitaxel","value":28.3}],"hr":1.11,"ci":[0.76,1.64],"source":"https://www.annalsofoncology.org/article/S0923-7534(21)02012-3/fulltext"}],"replication":"Failed to replicate IMpassion130; the discordance is attributed to the taxane partner (steroid premedication with paclitaxel) and chance."},{"id":"nct06044623","kind":"trial","name":"Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients","aka":["IMPORTANT"],"tldr":"A phase 3 trial of Geriatric assessment in Breast cancer, run by Region Örebro County, now recruiting.","summary":"Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients is a phase 3 interventional study registered as NCT06044623 by Region Örebro County, with 495 participants planned, started 2024-04-01 and due to reach its primary completion in 2028-10-31. Interventions recorded: CDK 4/6 inhibitors, Endocrine therapy. Conditions recorded: Metastatic Breast Cancer, Advanced Breast Cancer, Quality of Life, Toxicity, Older Patients.\n\nLinked to the technology Geriatric assessment because the registry's title names it (\"geriatric assessment\") and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06044623","url":"https://clinicaltrials.gov/study/NCT06044623"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["geriatric-assessment"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06044623","phase":"3","setting":"Implementing Geriatric Assessment for Dose Optimization of CDK 4/6-inhibitors in Older Breast Cancer Patients - a Pragmatic Randomized-controlled Trial (IMPORTANT Trial)","sponsor":"Region Örebro County","started":"2024-04-01","startedType":"actual","enrolled":495,"enrolledBasis":"registry","outcomes":[]},{"id":"import-low","kind":"trial","name":"IMPORT LOW","aka":[],"tldr":"IMPORT LOW showed that treating only the part of the breast around the tumour bed, with the same simple technique and schedule, is as safe as whole-breast radiotherapy and causes fewer changes to the breast.","summary":"IMPORT LOW randomised 2,018 women with low-risk breast cancer to whole-breast radiotherapy, whole-breast with reduced dose outside the tumour bed, or partial-breast radiotherapy only, all 40 Gy in 15 fractions with standard tangential fields. Five-year local relapse was 1.1 percent after whole-breast and 0.5 percent after partial-breast treatment, non-inferior, with fewer reported changes in breast appearance (Coles and colleagues, Lancet 2017).","status":"positive","asOf":"2026-09-16","links":[{"label":"ISRCTN12852634","url":"https://www.isrctn.com/ISRCTN12852634"},{"label":"Lancet 2017","url":"https://doi.org/10.1016/S0140-6736(17)31145-5"}],"tags":["radiation-wave2"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive","tnbc","breast-cancer"],"sections":[],"technologies":["hypofractionated-radiotherapy","imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":["icr-london"],"pathways":[],"terms":["partial-breast-irradiation","tumour-bed-boost"],"trials":["rapid","targit-a","eortc-22881-boost"],"people":[],"bottlenecks":[],"keyPapers":["paper-coles-lancet"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Low-risk early breast cancer: partial-breast or reduced-dose radiotherapy versus whole-breast radiotherapy, 40 Gy in 15 fractions","sponsor":"Institute of Cancer Research (UK)","result":"5-year local relapse 0.5% (partial breast) vs 1.1% (whole breast), non-inferior; fewer breast changes.","yearReported":2017,"enrolled":2018,"enrolledBasis":"registry","outcomes":[{"endpoint":"Local relapse at 5 years","primary":true,"unit":"%","arms":[{"name":"Partial-breast radiotherapy","n":674,"value":0.5},{"name":"Whole-breast radiotherapy","n":674,"value":1.1}]}]},{"id":"impower110","kind":"trial","name":"IMpower110","aka":[],"tldr":"Showed that for people whose tumours are covered in PD-L1, a single immunotherapy drug can replace first-line chemotherapy, adding about seven months of life.","summary":"IMpower110 enrolled 572 patients with untreated metastatic non-small-cell lung cancer of either histology whose tumours expressed PD-L1 on at least 1 percent of tumour cells or tumour-infiltrating immune cells by the SP142 assay, and randomised them 1:1 to atezolizumab alone or to platinum-based chemotherapy. Overall survival was tested hierarchically by PD-L1 expression level within the EGFR and ALK wild-type population.\n\nIn the 205 patients with the highest PD-L1 expression, median overall survival was 20.2 months with atezolizumab against 13.1 months with chemotherapy, a 7.1-month difference (hazard ratio for death 0.59, p=0.01), regardless of histological type. Adverse events occurred in 90.2 percent on atezolizumab and 94.7 percent on chemotherapy, with grade 3 or 4 events in 30.1 and 52.5 percent: the toxicity argument for single-agent immunotherapy is as strong as the efficacy one. Blood-based tumour mutational burden also selected patients who did better.\n\nThe FDA approved atezolizumab as first-line monotherapy for high PD-L1 expression in 2020. In England NICE TA705 (2 June 2021) recommends atezolizumab monotherapy for untreated advanced disease. The trial also illustrated the assay problem: SP142 scores differently from the 22C3 assay used in KEYNOTE-024, so a patient can be PD-L1-high for one drug and not for another.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02409342","url":"https://clinicaltrials.gov/study/NCT02409342"},{"label":"IMpower110 (New England Journal of Medicine 2020)","url":"https://doi.org/10.1056/NEJMoa1917346"},{"label":"NICE TA705: atezolizumab monotherapy for untreated advanced non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta705"}],"tags":[],"related":[],"cancers":["pdl1-high-nsclc","nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","companion-diagnostic","platinum"],"targets":["pdl1"],"drugs":["atezolizumab","carboplatin","cisplatin"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["tps","pd-l1-testing","tmb"],"trials":["keynote-024-189","keynote-042","empower-lung-1"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02409342","phase":"3","setting":"Untreated metastatic non-squamous or squamous non-small-cell lung cancer with PD-L1 on at least 1 percent of tumour cells or tumour-infiltrating immune cells by the SP142 assay: atezolizumab alone versus platinum-based chemotherapy, with overall survival tested hierarchically by PD-L1 level in the EGFR and ALK wild-type population","sponsor":"Roche","result":"In the PD-L1-highest subgroup, median overall survival 20.2 against 13.1 months (hazard ratio 0.59, p=0.01).","started":"2015-07-20","startedType":"actual","yearReported":2020,"enrolled":572,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (highest PD-L1 expression, EGFR and ALK wild-type)","primary":true,"unit":"months","arms":[{"name":"Atezolizumab","value":20.2},{"name":"Platinum-based chemotherapy","value":13.1}],"hr":0.59,"p":"0.01","source":"https://doi.org/10.1056/NEJMoa1917346"}],"replication":"KEYNOTE-024 and EMPOWER-Lung 1 showed the same with pembrolizumab and cemiplimab in PD-L1-high disease; KEYNOTE-042 extended it, weakly, to PD-L1 1 percent or more."},{"id":"impower133","kind":"trial","name":"IMpower133","aka":[],"tldr":"IMpower133 was the first trial in decades to lengthen survival in extensive-stage small-cell lung cancer, by adding immunotherapy to chemotherapy.","summary":"Median OS 12.3 vs 10.3 months (HR 0.70); PFS 5.2 vs 4.3 months. Established chemo-immunotherapy as first-line standard (FDA March 2019). The IMbrella A extension reported the first five-year survival data for chemo-immunotherapy in ES-SCLC, with a small tail of long-term survivors in the atezolizumab arm. Benefit was independent of PD-L1 and TMB.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02763579","url":"https://clinicaltrials.gov/study/NCT02763579"},{"label":"Five-year OS (IMbrella A)","url":"https://pubmed.ncbi.nlm.nih.gov/39306923/"}],"tags":[],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab","platinum-etoposide"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["anne-chiang"],"bottlenecks":[],"keyPapers":["paper-impower133-n-engl-j-med-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02763579","phase":"3","setting":"First-line extensive-stage SCLC: carboplatin-etoposide + atezolizumab vs carboplatin-etoposide + placebo","sponsor":"Roche","result":"OS 12.3 vs 10.3 months, HR 0.70.","started":"2016-06-07","startedType":"actual","yearReported":2018,"enrolled":403,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Atezolizumab + CE","n":201,"value":12.3},{"name":"Placebo + CE","n":202,"value":10.3}],"hr":0.7,"ci":[0.54,0.91],"p":"0.007","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1809064"},{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Atezolizumab + CE","value":5.2},{"name":"Placebo + CE","value":4.3}],"hr":0.77,"ci":[0.62,0.96],"source":"https://doi.org/10.1056/NEJMoa1809064"}],"replication":"Replicated by CASPIAN (durvalumab, 2019) and by serplulimab (ASTRUM-005), tislelizumab (RATIONALE-312), adebrelimab and toripalimab trials in China; the class effect is one of the best-replicated in SCLC."},{"id":"impower150","kind":"trial","name":"IMpower150","aka":[],"tldr":"Added an anti-VEGF antibody to chemotherapy and immunotherapy, and is the one first-line regimen with evidence in people whose cancer is driven by an EGFR or ALK change.","summary":"IMpower150 had three arms: atezolizumab with carboplatin and paclitaxel, bevacizumab with carboplatin and paclitaxel, and atezolizumab with bevacizumab, carboplatin and paclitaxel, each for four or six cycles followed by maintenance. The comparison that mattered was the four-drug arm against the bevacizumab arm, tested first, in the EGFR and ALK wild-type population, where 356 and 336 patients were assigned.\n\nMedian progression-free survival was 8.3 months with the four-drug regimen against 6.8 months (hazard ratio for progression or death 0.62, 95 percent confidence interval 0.52 to 0.74), and overall survival was also significantly improved, regardless of PD-L1 expression or effector T-cell signature.\n\nIMpower150 is quoted most often for something outside its primary analysis: its exploratory subgroup of patients with EGFR or ALK alterations who had progressed on targeted therapy did appear to benefit, which is why the four-drug regimen is still considered there when nothing else applies, and why the argument persists, since the subgroup is small and the finding exploratory. The FDA approved the regimen in 2018. In England NICE TA584 (5 June 2019) recommends atezolizumab in combination for metastatic non-squamous disease.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02366143","url":"https://clinicaltrials.gov/study/NCT02366143"},{"label":"IMpower150 (New England Journal of Medicine 2018)","url":"https://doi.org/10.1056/NEJMoa1716948"},{"label":"NICE TA584: atezolizumab in combination for treating metastatic non-squamous non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta584"}],"tags":[],"related":[],"cancers":["lung-adenocarcinoma","nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","antiangiogenic","cytotoxic-chemotherapy","platinum"],"targets":["pdl1","vegf"],"drugs":["atezolizumab","bevacizumab","carboplatin","paclitaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["immune-checkpoint","resistance"],"trials":["keynote-024-189"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02366143","phase":"3","setting":"Untreated metastatic non-squamous non-small-cell lung cancer: atezolizumab with carboplatin and paclitaxel, bevacizumab with carboplatin and paclitaxel, or atezolizumab with all three, every three weeks for four or six cycles then maintenance, with co-primary progression-free survival endpoints in the wild-type and effector T-cell-high populations and overall survival in the wild-type population","sponsor":"Roche","result":"Median progression-free survival 8.3 against 6.8 months (hazard ratio 0.62) and significantly longer overall survival for atezolizumab with bevacizumab and chemotherapy over bevacizumab and chemotherapy.","started":"2015-03-31","startedType":"actual","yearReported":2018,"enrolled":1202,"enrolledBasis":"randomised","enrolledNote":"692 patients in the two compared arms of the EGFR and ALK wild-type population are quoted in the primary analysis; the registry figure counts all three arms and the whole intention-to-treat population.","outcomes":[{"endpoint":"Progression-free survival (EGFR and ALK wild-type)","primary":true,"unit":"months","arms":[{"name":"Atezolizumab, bevacizumab, carboplatin and paclitaxel","n":356,"value":8.3},{"name":"Bevacizumab, carboplatin and paclitaxel","n":336,"value":6.8}],"hr":0.62,"ci":[0.52,0.74],"source":"https://doi.org/10.1056/NEJMoa1716948"}]},{"id":"impress-trial","kind":"trial","name":"IMPRESS (algenpantucel-L)","aka":[],"tldr":"The largest vaccine trial after pancreatic cancer surgery found that algenpantucel-L added nothing to standard chemotherapy.","summary":"IMPRESS enrolled 722 patients after resection of pancreatic adenocarcinoma and randomised them to standard adjuvant therapy with or without the whole-cell vaccine algenpantucel-L. Overall survival, the primary endpoint, was not improved, ending the hyperacute vaccine approach in this disease.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01072981","url":"https://clinicaltrials.gov/study/NCT01072981"}],"tags":[],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["shared-antigen-vaccine"],"targets":[],"drugs":["algenpantucel-l","gemcitabine"],"companies":["newlink-genetics"],"institutions":[],"pathways":[],"terms":["vaccines-and-oncolytic-viruses"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01072981","phase":"3","setting":"Resected pancreatic cancer: adjuvant gemcitabine with or without chemoradiation, with or without algenpantucel-L","sponsor":"NewLink Genetics","result":"No overall survival benefit.","started":"2010-04","yearReported":2016,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05744219","kind":"trial","name":"Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial","aka":["IRIS"],"tldr":"A phase 3 trial in pancreatic cancer, run by Jon Unosson, now recruiting.","summary":"Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial is a phase 3, randomised interventional study registered as NCT05744219 by Jon Unosson, with a registry enrolment figure of 338 participants, started 2024-09-04 and due to reach its primary completion in 2027-12-31. Interventions recorded: Ferric carboxymaltose; Placebo. Conditions listed: Surgery; Liver Metastases; Liver Cancer; Pancreas Cancer; Aortic Aneurysm. Primary outcome: Recovery after iv Iron. Pancreatic eligibility wording from the registry: \"Scheduled for complex aortic surgery, liver resection or pancreatic resection\". Sites: Sweden. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05744219","url":"https://clinicaltrials.gov/study/NCT05744219"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05744219","phase":"3","setting":"Improved Recovery by Iron Following Surgery With Blood Loss, a Double-blind Multi-centre Randomized Controlled Phase III Drug Trial (the IRIS-trial)","sponsor":"Jon Unosson","started":"2024-09-04","startedType":"actual","enrolled":338,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07548736","kind":"trial","name":"Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, not yet recruiting.","summary":"Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury is a phase 2, randomised interventional study registered as NCT07548736 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 40 participants, started 2026-04-24 and due to reach its primary completion in 2027-04-24. Interventions recorded: Experimental Group (dexamethasone enema); Control group (dexamethasone enema). Conditions listed: Acute Radiation Enteritis. Primary outcome: Improvement rate of radiation-induced rectal injury. Colorectal eligibility wording from the registry: \"Patients pathologically diagnosed with rectal cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07548736","url":"https://clinicaltrials.gov/study/NCT07548736"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07548736","phase":"2","setting":"Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury: a Phase II Randomized Controlled Clinical Trial","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2026-04-24","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06936774","kind":"trial","name":"Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance","aka":["iRECOVER"],"tldr":"A phase 3 trial in colorectal cancer, run by University Hospital, Basel, Switzerland, now recruiting.","summary":"Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance is a phase 3, randomised interventional study registered as NCT06936774 by University Hospital, Basel, Switzerland, with a registry enrolment figure of 140 participants, started 2025-12-01 and due to reach its primary completion in 2028-05-01. Interventions recorded: Intensified follow-up program. Conditions listed: LARS - Low Anterior Resection Syndrome; Rectal Cancer Surgery; Rectal Cancer; Quality of Life (QOL). Primary outcome: Improvement of the LARS score after 13 months. Colorectal eligibility wording from the registry: \"* patients with rectal cancer in the middle and lower third of the rectum in stages I to IV who underwent LAR with TME and protective ileostomy\". Sites: Switzerland. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06936774","url":"https://clinicaltrials.gov/study/NCT06936774"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06936774","phase":"3","setting":"Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance - a Randomized Controlled Trial (iRECOVER)","sponsor":"University Hospital, Basel, Switzerland","started":"2025-12-01","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"imroz","kind":"trial","name":"IMROZ","aka":[],"tldr":"In IMROZ, isatuximab added to VRd cut progression by 40% in older patients not having a transplant.","summary":"IMROZ, trial NCT03319667 sponsored by Sanofi and published in the New England Journal of Medicine in 2024, showed that adding isatuximab to bortezomib, lenalidomide and dexamethasone cut the risk of progression by forty percent in newly diagnosed transplant-ineligible myeloma patients aged eighty or under. It randomised 446 patients, met its primary progression-free survival endpoint at 60 months with a higher rate of MRD-negative complete response, and led to approval in September 2024. OnCo links it to multiple myeloma, isatuximab, bortezomib, lenalidomide, Thierry Facon, the quadruplet pairing and the CEPHEUS paper. With daratumumab and isatuximab quadruplets both approved in this setting, whether the two CD38 antibodies differ is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03319667","url":"https://clinicaltrials.gov/study/NCT03319667"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-transplant-ineligible"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["isatuximab","bortezomib","lenalidomide"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["thierry-facon"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03319667","phase":"3","setting":"Newly diagnosed transplant-ineligible myeloma (age ≤80): Isa-VRd vs VRd","sponsor":"Sanofi","result":"PFS HR 0.60.","started":"2017-12-07","startedType":"actual","yearReported":2024,"enrolled":475,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 60 months","primary":true,"unit":"%","arms":[{"name":"Isa-VRd","n":265,"value":63.2},{"name":"VRd","n":181,"value":45.2}],"hr":0.6,"ci":[0.41,0.88],"p":"0.0005","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2400712"}]},{"id":"imspire150","kind":"trial","name":"IMspire150","aka":[],"tldr":"IMspire150 tested adding the immunotherapy drug atezolizumab to the two targeted pills used for BRAF-mutant melanoma; the triple combination kept the cancer from growing for longer as judged by the treating doctors, which earned it approval, but it did not help people live longer.","summary":"IMspire150 was a double-blind placebo-controlled phase 3 trial in previously untreated BRAF V600 mutation-positive unresectable or metastatic melanoma. After a 28-day run-in of vemurafenib and cobimetinib, patients continued the two targeted drugs with atezolizumab or placebo.\n\nInvestigator-assessed progression-free survival, the primary endpoint, was significantly longer with the triplet, which led to approval of atezolizumab with vemurafenib and cobimetinib in the United States in July 2020. Independent review did not confirm a significant difference, and the final overall survival analysis found no significant benefit. The trial, alongside COMBI-i, showed that layering a checkpoint inhibitor onto BRAF and MEK inhibition adds toxicity for a modest gain, and sequencing trials such as DREAMseq favour starting with immunotherapy.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02908672","url":"https://clinicaltrials.gov/study/NCT02908672"}],"tags":["subtype-trials"],"related":[],"cancers":["braf-v600-melanoma","melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab","vemurafenib","cobimetinib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ralf-gutzmer"],"bottlenecks":[],"keyPapers":["paper-imspire150-lancet-2020","paper-imspire150-lancet-oncol-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02908672","phase":"3","setting":"Untreated BRAF V600-mutant advanced melanoma: atezolizumab or placebo added to vemurafenib and cobimetinib after a 28-day run-in of the two targeted drugs","sponsor":"Roche","result":"Atezolizumab added to vemurafenib and cobimetinib prolonged investigator-assessed progression-free survival in BRAF V600-mutant melanoma, without an overall survival benefit; approved in July 2020.","started":"2017-01-13","startedType":"actual","yearReported":2020,"enrolled":514,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (investigator-assessed)","primary":true,"unit":"months","arms":[{"name":"Atezolizumab + vemurafenib + cobimetinib","n":256,"value":15.1,"note":"Median follow-up 18.9 months"},{"name":"Placebo + vemurafenib + cobimetinib","n":258,"value":10.6}],"hr":0.78,"ci":[0.63,0.97],"p":"0.025","source":"https://doi.org/10.1016/s0140-6736(20)30934-x"},{"endpoint":"Stopped all treatment for adverse events","unit":"%","arms":[{"name":"Atezolizumab + vemurafenib + cobimetinib","n":256,"value":13},{"name":"Placebo + vemurafenib + cobimetinib","n":258,"value":16}],"source":"https://doi.org/10.1016/s0140-6736(20)30934-x"}]},{"id":"imvigor011","kind":"trial","name":"IMvigor011","aka":[],"tldr":"The first trial to use a blood test for leftover cancer to decide who gets immunotherapy, and it worked.","summary":"IMvigor011, trial NCT04660344 sponsored by Roche and reported in 2025, was the first trial to use a blood test for leftover cancer to decide who gets immunotherapy, and it worked. It enrolled 761 patients after cystectomy for muscle-invasive bladder cancer, randomised those who were circulating tumour DNA-positive by Signatera to atezolizumab or placebo, met its primary disease-free survival endpoint and improved overall survival, while persistently ctDNA-negative patients had excellent outcomes without treatment, leading to FDA approval in the second quarter of 2026 as the first ctDNA-guided indication. Whether the approach transfers to other cancers is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT04660344","url":"https://clinicaltrials.gov/study/NCT04660344"}],"tags":[],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":["atezolizumab","signatera"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["mrd","ctdna"],"trials":[],"people":["thomas-powles"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04660344","phase":"3","setting":"Muscle-invasive bladder cancer after cystectomy, ctDNA-positive (Signatera): atezolizumab vs placebo","sponsor":"Roche","result":"DFS HR 0.64; OS HR 0.59 in ctDNA+.","started":"2021-05-03","startedType":"actual","yearReported":2025,"enrolled":761,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival (ctDNA-positive, randomised)","primary":true,"unit":"months","arms":[{"name":"Atezolizumab","n":167,"value":9.9},{"name":"Placebo","n":83,"value":4.8}],"hr":0.64,"ci":[0.47,0.88],"p":"0.005","source":"https://www.roche.com/media/releases/med-cor-2025-10-20b"},{"endpoint":"Overall survival (ctDNA-positive)","unit":"months","arms":[{"name":"Atezolizumab","value":32.8},{"name":"Placebo","value":21.1}],"hr":0.59,"ci":[0.41,0.86],"p":"0.005","source":"https://www.roche.com/media/releases/med-cor-2025-10-20b"},{"endpoint":"Disease-free survival at 12 months, persistently ctDNA-negative (untreated surveillance)","unit":"%","arms":[{"name":"ctDNA-negative, surveillance only","n":357,"value":95.4,"note":"12-month OS 100% in this group"}],"source":"https://www.roche.com/media/releases/med-cor-2025-10-20b"}],"replication":"Contrasts with IMvigor010 (unselected adjuvant atezolizumab, negative), whose exploratory ctDNA analysis generated the hypothesis; IMvigor011 is the prospective confirmation."},{"id":"nct05994131","kind":"trial","name":"IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC","aka":[],"tldr":"A phase 1/2 trial of IN10018 and Furmonertinib in non-small-cell lung cancer, run by InxMed (Shanghai) Co., Ltd., now recruiting.","summary":"IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC is a phase 1/2 interventional study registered as NCT05994131 by InxMed (Shanghai) Co., Ltd., with 110 participants planned, started 2023-07-13 and due to reach its primary completion in 2026-07-31. Interventions recorded: IN10018 and Furmonertinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05994131","url":"https://clinicaltrials.gov/study/NCT05994131"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["in10018","furmonertinib"],"companies":["inxmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05994131","phase":"1/2","setting":"A Multicenter, Open-label, Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Anti-tumor Efficacy of IN10018 Combined With Third-generation EGFR-TKI in Patients With Advanced EGFR Mutation-positive NSCLC","sponsor":"InxMed (Shanghai) Co., Ltd.","started":"2023-07-13","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06030258","kind":"trial","name":"IN10018 Combination Therapy in Treatment-naïve ES-SCLC","aka":[],"tldr":"A phase 1/2 trial of IN10018, Tislelizumab, Carboplatin in small-cell lung cancer, run by InxMed (Shanghai) Co., Ltd., now recruiting.","summary":"IN10018 Combination Therapy in Treatment-naïve ES-SCLC is a phase 1/2 interventional study registered as NCT06030258 by InxMed (Shanghai) Co., Ltd., with 120 participants planned, started 2023-10-30 and due to reach its primary completion in 2025-12-24. Interventions recorded: IN10018, Tislelizumab, Carboplatin, Etoposide. Conditions listed: Small Cell Lung Cancer Extensive Stage. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06030258","url":"https://clinicaltrials.gov/study/NCT06030258"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["in10018","tislelizumab","carboplatin","etoposide"],"companies":["inxmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06030258","phase":"1/2","setting":"A Phase Ib/II Clinical Trial to Evaluate the Anti-tumor Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Anti-PD-1/L1 Antibody and Chemotherapy as First-line Treatment in Extensive-stage Small Cell Lung Cancer","sponsor":"InxMed (Shanghai) Co., Ltd.","started":"2023-10-30","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06014528","kind":"trial","name":"IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurren","aka":[],"tldr":"A phase 2 trial of IN10018, Pegylated liposomal doxorubicin in ovarian cancer, run by InxMed (Shanghai) Co., Ltd., now recruiting.","summary":"IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer is a phase 2 interventional study registered as NCT06014528 by InxMed (Shanghai) Co., Ltd., with 168 participants planned, started 2022-09-06 and due to reach its primary completion in 2026-12-24. Interventions recorded: IN10018, Placebo of IN10018, Pegylated Liposomal Doxorubicin. Conditions listed: Ovarian Cancer Recurrent. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06014528","url":"https://clinicaltrials.gov/study/NCT06014528"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["in10018","pegylated-liposomal-doxorubicin"],"companies":["inxmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06014528","phase":"2","setting":"A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer","sponsor":"InxMed (Shanghai) Co., Ltd.","started":"2022-09-06","startedType":"actual","enrolled":168,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07441174","kind":"trial","name":"IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of IN10018 in advanced solid tumours, run by InxMed (Shanghai) Co., Ltd., now recruiting.","summary":"IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT07441174 by InxMed (Shanghai) Co., Ltd., with 92 participants planned, started 2026-02-28 and due to reach its primary completion in 2031-02-28. Interventions recorded: IN10018 in combination with RNK08954.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07441174","url":"https://clinicaltrials.gov/study/NCT07441174"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["in10018"],"companies":["ranok-therapeutics-hangzhou"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07441174","phase":"1/2","setting":"A Multicenter, Open-Label, Phase Ib/II Clinical Trial of IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors","sponsor":"InxMed (Shanghai) Co., Ltd.","started":"2026-02-28","startedType":"estimated","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05551507","kind":"trial","name":"IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer","aka":[],"tldr":"A phase 1/2 trial of IN10018 in ovarian cancer, run by InxMed (Shanghai) Co., Ltd., now recruiting.","summary":"IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer is a phase 1/2 interventional study registered as NCT05551507 by InxMed (Shanghai) Co., Ltd., with 150 participants planned, started 2020-07-27 and due to reach its primary completion in 2026-05-31. Interventions recorded: IN10018 in combination with PLD. Conditions listed: Platinum-resistant Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05551507","url":"https://clinicaltrials.gov/study/NCT05551507"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["in10018"],"companies":["inxmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05551507","phase":"1/2","setting":"A Phase Ib/II, Open-label Clinical Study to Evaluate the Safety, Tolerability and Antitumor Activities of IN10018 in Combination With Standard Chemotherapy in Subjects With High-grade Serous Epithelial Ovarian Cancer","sponsor":"InxMed (Shanghai) Co., Ltd.","started":"2020-07-27","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05827796","kind":"trial","name":"IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of IN10018 and Gemcitabine in pancreatic ductal adenocarcinoma, run by InxMed (Shanghai) Co., Ltd., now recruiting.","summary":"IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer is a phase 1/2 interventional study registered as NCT05827796 by InxMed (Shanghai) Co., Ltd., with 70 participants planned, started 2022-12-08 and due to reach its primary completion in 2025-12-31. Interventions recorded: IN10018, Albumin-Bound Paclitaxel, Gemcitabine and KN046.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05827796","url":"https://clinicaltrials.gov/study/NCT05827796"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["in10018","gemcitabine"],"companies":["inxmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05827796","phase":"1/2","setting":"A Phase Ib/II, Open-label Clinical Study to Evaluate the Safety, Tolerability and Antitumor Activities of IN10018+Standard Chemotherapy and IN10018+Standard Chemotherapy+KN046 in Subjects With Advanced Pancreatic Cancer","sponsor":"InxMed (Shanghai) Co., Ltd.","started":"2022-12-08","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"inavo120","kind":"trial","name":"INAVO120","aka":[],"tldr":"A triple combination that doubled progression-free time and, unusually for this disease, extended survival by seven months in a hard-to-treat group.","summary":"INAVO120, trial NCT04191499 sponsored by Roche and Genentech and reported in 2023, tested a triple combination that doubled progression-free time and, unusually for this disease, extended overall survival in first-line PIK3CA-mutant HR-positive, HER2-negative advanced breast cancer relapsing on or after adjuvant endocrine therapy. It randomised 325 women to inavolisib or placebo with palbociclib and fulvestrant, met its primary progression-free survival endpoint with a large effect, showed a significant survival benefit at the final analysis and a much higher response rate, and led to approval in October 2024; inavolisib degrades mutant p110-alpha, giving less hyperglycaemia than alpelisib. INAVO121 and INAVO122 are ongoing, and whether the benefit extends to later lines is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04191499","url":"https://clinicaltrials.gov/study/NCT04191499"},{"label":"NEJM OS analysis","url":"https://www.nejm.org/doi/abs/10.1056/NEJMoa2501796"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":["pik3ca","cdk4-6"],"drugs":["inavolisib","palbociclib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["komal-jhaveri"],"bottlenecks":[],"keyPapers":["paper-inavo120-n-engl-j-med-2024","paper-inavo120-n-engl-j-med-2025-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04191499","phase":"2/3","setting":"First-line PIK3CA-mutant HR+/HER2- advanced breast cancer relapsing on/after adjuvant endocrine therapy: inavolisib + palbociclib + fulvestrant vs placebo + palbociclib + fulvestrant","sponsor":"Roche / Genentech","result":"PFS 15.0 vs 7.3 months, HR 0.43; OS 34.0 vs 27.0 months, HR 0.67.","started":"2020-01-29","startedType":"actual","yearReported":2023,"enrolled":325,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Inavolisib + palbociclib + fulvestrant","n":161,"value":15},{"name":"Placebo + palbociclib + fulvestrant","n":164,"value":7.3}],"hr":0.43,"ci":[0.32,0.59],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2404625"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Inavolisib arm","value":34},{"name":"Placebo arm","value":27}],"hr":0.67,"ci":[0.48,0.94],"p":"0.02","source":"https://www.nejm.org/doi/abs/10.1056/NEJMoa2501796"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Inavolisib arm","value":62.7},{"name":"Placebo arm","value":28}],"source":"https://doi.org/10.1056/NEJMoa2404625"}],"replication":"Single pivotal trial; INAVO121 (vs alpelisib) and INAVO122 (HER2+) ongoing."},{"id":"nct06295731","kind":"trial","name":"INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC","aka":["HexAgon-HN"],"tldr":"A phase 2/3 trial testing INBRX-106 in head and neck squamous cell carcinoma, active and no longer recruiting.","summary":"INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC is a phase 2/3 interventional study registered as NCT06295731, led by Inhibrx Biosciences, and active but no longer recruiting on the registry. Official title: A Phase 2/3, Randomised Study of INBRX-106 Combined With Pembrolizumab Versus Pembrolizumab as First Line Treatment for Patients With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 (CPS ≥20) (HexAgon-HN). Planned enrolment is 410 participants (estimated). The study started in 2024-05-14 and primary completion is expected in 2029-05. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06295731","url":"https://clinicaltrials.gov/study/NCT06295731"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["inbrx-106"],"companies":["inhibrx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06295731","phase":"2/3","setting":"A Phase 2/3, Randomized Study of INBRX-106 Combined With Pembrolizumab Versus Pembrolizumab as First Line Treatment for Patients With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 (CPS ≥20) (HexAgon-HN)","sponsor":"Inhibrx Biosciences","started":"2024-05-14","startedType":"actual","enrolled":410,"enrolledBasis":"registry","outcomes":[]},{"id":"keynote-483","kind":"trial","name":"IND.227 / KEYNOTE-483","aka":[],"tldr":"Showed that adding a PD-1 blocker to standard chemotherapy helps in mesothelioma, giving a second immunotherapy-based first-line option.","summary":"IND.227, also KEYNOTE-483, trial NCT02784171 sponsored by the Canadian Cancer Trials Group with Merck and reported in 2023, showed that adding pembrolizumab to platinum and pemetrexed helps in unresectable pleural mesothelioma, giving a second immunotherapy-based first-line option. It randomised 440 patients, met its primary overall survival endpoint with a modest effect and a much higher response rate, with benefit again concentrated in non-epithelioid disease, and led to FDA approval on 17 September 2024; it was an academic-led trial with industry drug supply. OnCo links it to mesothelioma, pembrolizumab, pemetrexed, the epithelioid versus sarcomatoid term and the histology pairing; DREAM supported it in phase 2, but the DREAM3R phase 3 was stopped early and BEAT-meso missed survival. Whether the modest benefit holds up outside non-epithelioid disease is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02784171","url":"https://clinicaltrials.gov/study/NCT02784171"},{"label":"Merck OS announcement","url":"https://www.merck.com/news/keytruda-pembrolizumab-plus-chemotherapy-significantly-improved-overall-survival-versus-chemotherapy-alone-as-first-line-treatment-for-advanced-malignant-pleural-mesothelioma/"}],"tags":[],"related":[],"cancers":["mesothelioma","pleural-mesothelioma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","pemetrexed"],"companies":["cctg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02784171","phase":"2/3","setting":"Unresectable pleural mesothelioma, first line: pembrolizumab + platinum-pemetrexed vs platinum-pemetrexed","sponsor":"Canadian Cancer Trials Group / Merck","result":"OS 17.3 vs 16.1 months, HR 0.79; ORR 52% vs 29%.","started":"2016-11-11","startedType":"actual","yearReported":2023,"enrolled":440,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy","n":222,"value":17.3},{"name":"Chemotherapy","n":218,"value":16.1}],"hr":0.79,"ci":[0.64,0.98],"p":"0.0324","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01613-6/fulltext"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Pembrolizumab + chemotherapy","value":52},{"name":"Chemotherapy","value":29}],"source":"https://doi.org/10.1016/S0140-6736(23)01883-4"}],"replication":"Supported by DREAM (phase 2, durvalumab + chemotherapy) but DREAM3R phase 3 was stopped early; BEAT-meso (atezolizumab + bevacizumab + chemotherapy) missed OS."},{"id":"indigo","kind":"trial","name":"INDIGO","aka":[],"tldr":"The first targeted-therapy win in low-grade brain tumours: a pill that more than doubled the time before the tumour grew, delaying radiation and chemotherapy by years.","summary":"INDIGO, trial NCT04164901 sponsored by Servier and reported in 2023, delivered the first targeted-therapy win in low-grade brain tumours: the IDH inhibitor vorasidenib more than doubled the time before residual or recurrent grade 2 IDH-mutant glioma grew, delaying radiotherapy and chemotherapy by years. It randomised 331 patients with astrocytoma or oligodendroglioma after surgery and no prior radiotherapy or chemotherapy to vorasidenib or placebo, met its primary progression-free survival endpoint by blinded review with a large effect, sharply reduced the need for the next intervention, and led to FDA approval in August 2024. OnCo links it to IDH1 and IDH2 as targets, the mutant IDH pathway, Ingo K. Mellinghoff, Patrick Y. Wen and the brain as a bottleneck. Its long-term effect on survival and on malignant transformation is pending, which is the open question.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT04164901","url":"https://clinicaltrials.gov/study/NCT04164901"}],"tags":[],"related":[],"cancers":["glioblastoma","idh-mutant-astrocytoma","oligodendroglioma"],"sections":[],"technologies":["epigenetic-drugs","idh-inhibitors"],"targets":["idh"],"drugs":["vorasidenib"],"companies":["servier"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ingo-mellinghoff","patrick-wen"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04164901","phase":"3","setting":"Residual or recurrent grade 2 IDH-mutant astrocytoma or oligodendroglioma after surgery, no prior RT/chemo: vorasidenib vs placebo","sponsor":"Servier","result":"PFS 27.7 vs 11.1 months, HR 0.39.","started":"2020-01-05","startedType":"actual","yearReported":2023,"enrolled":331,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BIRC)","primary":true,"unit":"months","arms":[{"name":"Vorasidenib","n":168,"value":27.7},{"name":"Placebo","n":163,"value":11.1}],"hr":0.39,"ci":[0.27,0.56],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2304194"}],"replication":"Single pivotal trial; the first targeted therapy in low-grade glioma. Time to next intervention also improved (HR 0.26)."},{"id":"nct05914389","kind":"trial","name":"Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer","aka":["ICONIC"],"tldr":"A phase 2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) and capecitabine in colorectal cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer is a phase 2, randomised interventional study registered as NCT05914389 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 100 participants, started 2023-08 and due to reach its primary completion in 2025-08. Interventions recorded: Oxaliplatin; Capecitabine; Anti-PD-L1 Monoclonal Antibody; Clostridium butyricum; Colectomy. Conditions listed: Colon Neoplasm. Primary outcome: TRG0/1. Colorectal eligibility wording from the registry: \"* Pathologically diagnosed MSS or pMMR-type colon adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05914389","url":"https://clinicaltrials.gov/study/NCT05914389"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05914389","phase":"2","setting":"Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer: a Prospective Single-center Multi-arm Open-label Randomized Phase II Study","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2023-08","startedType":"estimated","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04389086","kind":"trial","name":"Induction Chemotherapy for Locally Recurrent Rectal Cancer","aka":["PelvEx II"],"tldr":"A phase 3 trial in colorectal cancer, run by Catharina Ziekenhuis Eindhoven, now recruiting.","summary":"Induction Chemotherapy for Locally Recurrent Rectal Cancer is a phase 3, randomised interventional study registered as NCT04389086 by Catharina Ziekenhuis Eindhoven, with a registry enrolment figure of 364 participants, started 2020-11-13 and due to reach its primary completion in 2024-03-01. Interventions recorded: Combination drug; Chemoradiotherapy; Surgery locally recurrent rectal cancer. Conditions listed: Recurrent Rectal Cancer. Primary outcome: Proportion of patients with a clear resection margin. Colorectal eligibility wording from the registry: \"* Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal or distal sigmoidal cancer either by histopathology ór clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT)\". Sites: Belgium, Netherlands, Norway, Portugal, Sweden. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04389086","url":"https://clinicaltrials.gov/study/NCT04389086"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04389086","phase":"3","setting":"Multicentre, Open-label, Randomised, Controlled, Parallel Arms Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy Alone as Neoadjuvant Treatment for Locally Recurrent Rectal Cancer - PelvEx II","sponsor":"Catharina Ziekenhuis Eindhoven","started":"2020-11-13","startedType":"actual","enrolled":364,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06793553","kind":"trial","name":"Induction Therapy of PTX+BV Followed by Atezolizumab+Nab-PTX for PD-L1+ TNBC","aka":["INDUCE"],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Japan Breast Cancer Research Group, now recruiting.","summary":"Induction Therapy of PTX+BV Followed by Atezolizumab+Nab-PTX for PD-L1+ TNBC is a phase 2, randomised interventional study registered as NCT06793553 by Japan Breast Cancer Research Group, with a registry enrolment figure of 106 participants, started 2024-09-13 and due to reach its primary completion in 2026-03-31. Interventions recorded: Induction therapy. Conditions listed: Metastatic Breast Cancer. Triple-negative eligibility wording from the registry: \"Diagnosed with metastatic recurrent or unresectable advanced TNBC\". Sites: Japan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06793553","url":"https://clinicaltrials.gov/study/NCT06793553"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06793553","phase":"2","setting":"Randomized Phase II Trial Evaluating the Efficacy of Paclitaxel+Bevacizumab INDUCtion Followed by at atEzolizumab+Nab-paclitaxel for PD-L1-positive Metastatic Triple Negative Breast Cancer (JBCRG-M10, CMA-0196) (INDUCE Trial)","sponsor":"Japan Breast Cancer Research Group","started":"2024-09-13","startedType":"actual","enrolled":106,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06857773","kind":"trial","name":"Induction Treatment for Initially Unresectable Colorectal Liver Metastases: Combined Hepatic Arterial Infusion Pump Therapy With Systemic Therapy","aka":["PUMP-IT RCT"],"tldr":"A phase 3 trial in colorectal cancer, run by The Netherlands Cancer Institute, now recruiting.","summary":"Induction Treatment for Initially Unresectable Colorectal Liver Metastases: Combined Hepatic Arterial Infusion Pump Therapy With Systemic Therapy is a phase 3, randomised interventional study registered as NCT06857773 by The Netherlands Cancer Institute, with a registry enrolment figure of 306 participants, started 2024-11-21 and due to reach its primary completion in 2030-01. Interventions recorded: Intra arterial infusion Floxuridine (FUDR) combined with systemic therapy; Hepatic arterial infusion pump (HAIP); Systemic therapy (standard of care). Conditions listed: Colorectal Neoplasms; Floxuridine; Liver Metastases; Vascular Access Device. Primary outcome: Overall survival. Colorectal eligibility wording from the registry: \"* Histologically confirmed colorectal adenocarcinoma\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06857773","url":"https://clinicaltrials.gov/study/NCT06857773"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06857773","phase":"3","setting":"Hepatic Arterial Infusion PUMP Chemotherapy Combined With Systemic Therapy Versus Systemic Therapy Alone as Induction Therapy for Initially Unresectable Colorectal Liver Metastases: a Randomised Controlled Trial","sponsor":"The Netherlands Cancer Institute","started":"2024-11-21","startedType":"actual","enrolled":306,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04736589","kind":"trial","name":"Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway","aka":[],"tldr":"A phase 3 trial of Inetetamab, Sirolimus protein-bound particles and Pyrotinib in Breast cancer, run by Peking Union Medical College, not yet recruiting.","summary":"Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway is a phase 3 interventional study registered as NCT04736589 by Peking Union Medical College, with 270 participants planned, started 2021-02-02 and due to reach its primary completion in 2024-02-02. Interventions recorded: Inetetamab, Rapamycin, Pyrotinib, Chemotherapy. Conditions recorded: Breast Cancer.\n\nLinked to the drug Inetetamab because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04736589","url":"https://clinicaltrials.gov/study/NCT04736589"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["inetetamab","sirolimus-albumin-bound","pyrotinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04736589","phase":"3","setting":"Efficacy and Safety of Inetetamab Combined With Rapamycin and Chemotherapy for HER2-positive Metastatic Breast Cancer Patients With Abnormal Activation of PI3K/Akt/mTOR Pathway After Progression on Trastuzumab.","sponsor":"Peking Union Medical College","started":"2021-02-02","startedType":"estimated","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02843945","kind":"trial","name":"Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source","aka":[],"tldr":"A phase 1/2 trial of Directional Brachytherapy Source Implant in pancreatic ductal adenocarcinoma, run by CivaTech Oncology, now recruiting.","summary":"Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source is a phase 1/2 interventional study registered as NCT02843945 by CivaTech Oncology, with 80 participants planned, started 2017-05-31 and due to reach its primary completion in 2027-10-29. Interventions recorded: Directional Brachytherapy Source Implant.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02843945","url":"https://clinicaltrials.gov/study/NCT02843945"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","borderline-resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["civatech-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02843945","phase":"1/2","setting":"Initial Feasibility Study to Evaluate the Safety and Efficacy of the Permanently Implantable LDR CivaSheet® in Combination With External Beam Radiation in the Treatment of Pancreatic Cancer","sponsor":"CivaTech Oncology","started":"2017-05-31","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06687681","kind":"trial","name":"Injection of Active Allogeneic Natural Killer Cells in Patients With Gliomas","aka":[],"tldr":"A phase 2 trial of NK cell therapy in glioma & glioblastoma, run by Marzieh Ebrahimi, now recruiting.","summary":"Injection of Active Allogeneic Natural Killer Cells in Patients With Gliomas is a phase 2 interventional study registered as NCT06687681 by Marzieh Ebrahimi, with 40 participants planned, started 2024-11-25 and due to reach its primary completion in 2025-11-25. Interventions recorded: NK cell therapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06687681","url":"https://clinicaltrials.gov/study/NCT06687681"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06687681","phase":"2","setting":"Efficacy of the Intrathecal Injection of Active Allogeneic Natural Killer Cells in Patients With High-grade Gliomas; A Multi-center Phase II Clinical Trial","sponsor":"Marzieh Ebrahimi","started":"2024-11-25","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07321847","kind":"trial","name":"Injection of IP-001 Into Thermally Ablated Hepatic Tumors in Patients With Colorectal Liver Metastases","aka":["INJECTABL-3"],"tldr":"A phase 2/3 trial in colorectal cancer, run by Immunophotonics, Inc., not yet recruiting.","summary":"Injection of IP-001 Into Thermally Ablated Hepatic Tumors in Patients With Colorectal Liver Metastases is a phase 2/3, randomised interventional study registered as NCT07321847 by Immunophotonics, Inc., with a registry enrolment figure of 717 participants, started 2026-05 and due to reach its primary completion in 2033-12. Interventions recorded: 1.0% IP-001 for Injection, a 10 mg/mL solution of IP-001 in water; 1.0% IP-001 for Injection, a 1 mg/mL solution of IP-001 in water.; Microwave (thermal) tumor ablation. Conditions listed: Colorectal Cancer (CRC); Colon Cancer Liver Metastases; Rectal Cancer; Rectal Cancer With Liver Metastases; Colorectal Liver Metastasis (CRLM). Primary outcome: To compare the efficacy of IP-001 following standard-of-care (SOC) complete hepatic tumor ablation vs SOC complete hepatic tumor ablation alone in prolonging progression-free survival. Colorectal eligibility wording from the registry: \"No residual primary colorectal tumor at Treatment Day 1 or plans to have the primary tumor excised within 4-12 weeks following Treatment Day 1\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07321847","url":"https://clinicaltrials.gov/study/NCT07321847"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["thermal-ablation"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07321847","phase":"2/3","setting":"Intratumoral Injection of IP-001 Following Standard-of-care Complete Hepatic Tumor Ablation in Patients With Liver-only Metastatic Colorectal Cancer","sponsor":"Immunophotonics, Inc.","started":"2026-05","startedType":"estimated","enrolled":717,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06199973","kind":"trial","name":"Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, ","aka":[],"tldr":"A phase 3 trial of Trastuzumab rezetecan, Trifluridine/tipiracil, Regorafenib in colorectal cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., active and no longer recruiting.","summary":"Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan is a phase 3 interventional study registered as NCT06199973 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 130 participants enrolled, started 2024-03-01 and due to reach its primary completion in 2026-04. Interventions recorded: SHR-A1811, TAS-102, Regorafenib , Fruquintinib. Conditions listed: Advanced Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06199973","url":"https://clinicaltrials.gov/study/NCT06199973"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","trifluridine-tipiracil","regorafenib","fruquintinib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06199973","phase":"3","setting":"Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2024-03-01","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"innovatv-301","kind":"trial","name":"innovaTV 301 / ENGOT-cx12 / GOG-3057","aka":[],"tldr":"The first ADC to extend life in cervical cancer, for women whose disease has come back after chemotherapy.","summary":"innovaTV 301, also ENGOT-cx12 and GOG-3057, trial NCT04697628 sponsored by Genmab and Pfizer through Seagen and published in the New England Journal of Medicine in 2024, produced the first antibody-drug conjugate to extend life in cervical cancer, for women whose disease has returned after one or two lines including platinum. It randomised 502 patients to tisotumab vedotin or investigator's choice chemotherapy, met its primary overall survival endpoint, improved progression-free survival and tripled the response rate, leading to full FDA approval in April 2024; ocular events in about half, mostly conjunctivitis, plus neuropathy and bleeding require mitigation. OnCo links it to cervical cancer, antibody-drug conjugates, tissue factor as a target, tisotumab vedotin, Ignace Vergote and Bradley J. Monk. Whether the drug can move earlier or combine with immunotherapy is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04697628","url":"https://clinicaltrials.gov/study/NCT04697628"},{"label":"NEJM 2024","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2313811"}],"tags":[],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["adc"],"targets":["tissue-factor"],"drugs":["tisotumab-vedotin"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ignace-vergote","bradley-monk"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04697628","phase":"3","setting":"Recurrent or metastatic cervical cancer after 1-2 prior lines including platinum: tisotumab vedotin vs investigator's-choice chemotherapy","sponsor":"Genmab / Pfizer (Seagen)","result":"OS 11.5 vs 9.5 months (HR 0.70).","started":"2021-02-22","startedType":"actual","yearReported":2023,"enrolled":502,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Tisotumab vedotin","n":253,"value":11.5},{"name":"Chemotherapy","n":249,"value":9.5}],"hr":0.7,"ci":[0.54,0.89],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2313811"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Tisotumab vedotin","value":4.2},{"name":"Chemotherapy","value":2.9}],"hr":0.67,"ci":[0.54,0.82],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2313811"}]},{"id":"nct03491683","kind":"trial","name":"INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM)","aka":[],"tldr":"A phase 1/2 trial of INO-5401, Cemiplimab and Temozolomide in glioma & glioblastoma, run by Inovio Pharmaceuticals, active and no longer recruiting.","summary":"INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) is a phase 1/2 interventional study registered as NCT03491683 by Inovio Pharmaceuticals, with 52 participants enrolled, started 2018-05-31 and due to reach its primary completion in 2026-12-31. Interventions recorded: INO-5401, INO-9012, Cemiplimab, Radiation Therapy and Temozolomide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03491683","url":"https://clinicaltrials.gov/study/NCT03491683"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ino-5401","cemiplimab","temozolomide"],"companies":["inovio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03491683","phase":"1/2","setting":"An Open-Label, Multi-Center Trial of INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With REGN2810 in Subjects With Newly-Diagnosed Glioblastoma (GBM)","sponsor":"Inovio Pharmaceuticals","started":"2018-05-31","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"ino-vate","kind":"trial","name":"INO-VATE ALL","aka":[],"tldr":"An antibody-drug conjugate put four in five relapsed ALL patients into remission versus fewer than one in three with chemotherapy.","summary":"INO-VATE ALL, trial NCT01564784 sponsored by Pfizer and published in the New England Journal of Medicine in 2016, showed that the CD22 antibody-drug conjugate inotuzumab ozogamicin put four in five adults with relapsed or refractory B-cell acute lymphoblastic leukaemia into remission versus fewer than one in three with intensive chemotherapy. It randomised 326 patients, met its primary remission endpoint with far higher MRD negativity and four times as many patients proceeding to transplant, while overall survival was not significantly different at the prespecified boundary, and hepatic veno-occlusive disease occurred in about a tenth. Whether lower frontline doses avoid the liver toxicity is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01564784","url":"https://clinicaltrials.gov/study/NCT01564784"}],"tags":[],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":["adc"],"targets":["cd22"],"drugs":["inotuzumab-ozogamicin"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["elias-jabbour","hagop-kantarjian"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01564784","phase":"3","setting":"Relapsed or refractory CD22+ B-ALL, adults: inotuzumab ozogamicin vs standard intensive chemotherapy","sponsor":"Pfizer","result":"CR/CRi 80.7% vs 29.4%; OS 7.7 vs 6.7 months.","started":"2012-08-02","startedType":"actual","yearReported":2016,"enrolled":326,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete remission / CRi","primary":true,"unit":"%","arms":[{"name":"Inotuzumab","n":109,"value":80.7},{"name":"Chemotherapy","n":109,"value":29.4}],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1509277"},{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Inotuzumab","n":164,"value":7.7},{"name":"Chemotherapy","n":162,"value":6.7}],"hr":0.77,"ci":[0.58,1.03],"p":"0.04 (did not meet boundary)","source":"https://doi.org/10.1056/NEJMoa1509277"}],"replication":"Paediatric ITCC-059 and COG AALL1621 reproduced ~60-80% remission rates; frontline Mini-hyper-CVD + InO series show high MRD negativity in older adults."},{"id":"nct03150693","kind":"trial","name":"Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia","aka":[],"tldr":"A phase 3 trial of Cytarabine, Daunorubicin, Vincristine, Dexamethasone, Methotrexate, Cyclophosphamide, Mercaptopurine, Rituximab, Doxorubicin, Thioguanine and Inotuzumab ozogamicin in Acute lymphoblastic leukaemia, run by Alliance for Clinical Trials in Oncology, now recruiting.","summary":"Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia is a phase 3 interventional study registered as NCT03150693 by Alliance for Clinical Trials in Oncology, with 303 participants planned, started 2017-09-20 and due to reach its primary completion in 2027-03-01. Interventions recorded: Allopurinol, Cytarabine, Daunorubicin Hydrochloride, Vincristine Sulfate, Dexamethasone, Pegylated L-Asparaginase, Methotrexate, Bone Marrow Aspiration and Biopsy, Cyclophosphamide, Mercaptopurine, Rituximab, Doxorubicin, Thioguanine, Inotuzumab Ozogamicin, Laboratory Biomarker Analysis. Conditions recorded: B Acute Lymphoblastic Leukemia.\n\nLinked to the drug Mercaptopurine because the registry names it among its interventions and Acute lymphoblastic leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03150693","url":"https://clinicaltrials.gov/study/NCT03150693"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":[],"targets":[],"drugs":["cytarabine","daunorubicin","vincristine","dexamethasone","methotrexate","cyclophosphamide","mercaptopurine","rituximab","doxorubicin","thioguanine","inotuzumab-ozogamicin"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03150693","phase":"3","setting":"A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL","sponsor":"Alliance for Clinical Trials in Oncology","started":"2017-09-20","startedType":"actual","enrolled":303,"enrolledBasis":"registry","outcomes":[]},{"id":"inpact","kind":"trial","name":"InPACT","aka":["International Penile Advanced Cancer Trial","EA8134","IRCI004"],"tldr":"InPACT is the first international trial in penile cancer that has spread to the groin nodes; it tests whether chemotherapy or chemoradiotherapy before removing the nodes, and preventive removal of pelvic nodes afterwards, help people live longer, and it is the reason chemoradiotherapy is offered within the trial as an alternative to chemotherapy.","summary":"InPACT is an International Rare Cancers Initiative phase 3 trial led by the Institute of Cancer Research with ECOG-ACRIN and the National Cancer Institute, using a Bayesian multi-arm design in about 200 patients with node-positive penile squamous cell carcinoma. The first randomisation compares standard inguinal lymph node dissection with neoadjuvant TIP chemotherapy or neoadjuvant cisplatin-based chemoradiotherapy before surgery; a second randomisation in patients at high risk of pelvic relapse compares prophylactic pelvic lymph node dissection with surveillance. The primary endpoint is overall survival.\n\nThe registry lists the trial as active and no longer recruiting with primary completion in 2027 and no results. The corpus's node-positive penile cancer page cites InPACT for chemoradiotherapy as an alternative to neoadjuvant chemotherapy within the trial.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02305654","url":"https://clinicaltrials.gov/study/NCT02305654"}],"tags":["soc-trials"],"related":[],"cancers":["node-positive-penile-cancer","penile"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["paclitaxel","ifosfamide","cisplatin"],"companies":["ecog-acrin"],"institutions":["icr-london"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02305654","phase":"3","setting":"Penile squamous cell carcinoma with inguinal lymph node involvement: a Bayesian multi-arm trial randomising between immediate inguinal node dissection, neoadjuvant paclitaxel, ifosfamide and cisplatin (TIP) then surgery, and neoadjuvant cisplatin chemoradiotherapy then surgery, with a second randomisation to prophylactic pelvic node dissection or surveillance in high-risk patients, and overall survival as the primary endpoint","sponsor":"Institute of Cancer Research, United Kingdom","started":"2017-05-12","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"insema","kind":"trial","name":"INSEMA (Intergroup Sentinel Mamma)","aka":["Intergroup Sentinel Mamma"],"tldr":"The largest trial of skipping the armpit operation, and the one with six years of follow-up. Women who had no lymph node surgery did as well as those who did, and had less arm swelling, better shoulder movement and less pain.","summary":"INSEMA randomised 5,502 eligible patients in a 1:4 ratio to no axillary surgery or to sentinel lymph node biopsy. All had clinically node-negative T1 or T2 invasive breast cancer and were scheduled for breast-conserving surgery; 90 percent had clinical T1 disease and 79 percent pathological T1 disease. The per-protocol population was 4,858, of whom 962 had no axillary surgery.\n\nAt a median follow-up of 73.6 months, the estimated five-year invasive disease-free survival was 91.9 percent (95 percent confidence interval 89.9 to 93.5) without axillary surgery and 91.7 percent (90.8 to 92.6) with sentinel node biopsy, a hazard ratio of 0.91 (0.73 to 1.14), below the non-inferiority margin of 1.271. Of the 525 first primary-outcome events, the apparent differences were in axillary recurrence, 1.0 percent without surgery against 0.3 percent with it, and in death, 1.4 against 2.4 percent. Patients who had no axillary surgery had less lymphoedema, greater arm mobility and less pain on moving the arm or shoulder.\n\nThe axillary recurrence figures are the number to hold on to: omitting the operation roughly triples a very small risk, from three in a thousand to ten in a thousand at five years, and does not change how long women live. Whether the same holds for invasive lobular carcinoma is disputed: a single-institution series found high rates of occult nodal positivity in lobular tumours meeting INSEMA and SOUND criteria.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02466737","url":"https://clinicaltrials.gov/study/NCT02466737"},{"label":"INSEMA primary results (New England Journal of Medicine 2025)","url":"https://doi.org/10.1056/NEJMoa2412063"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["sentinel-node"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["sentinel-lymph-node-biopsy","axillary-surgery-de-escalation","breast-cancer-related-lymphoedema"],"trials":["sound","nsabp-b32"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02466737","phase":"3","setting":"Clinically node-negative T1 or T2 invasive breast cancer scheduled for breast-conserving surgery: no axillary surgery against sentinel node biopsy, with five-year invasive disease-free survival as the primary endpoint and a non-inferiority margin of 1.271","sponsor":"University of Rostock, funded by German Cancer Aid","result":"Five-year invasive disease-free survival 91.9 percent without axillary surgery against 91.7 percent with sentinel node biopsy (hazard ratio 0.91, 0.73 to 1.14, non-inferior); axillary recurrence 1.0 against 0.3 percent.","started":"2015-09","startedType":"actual","yearReported":2025,"enrolled":5502,"enrolledBasis":"randomised","enrolledNote":"5,502 eligible patients were randomised in a 1:4 ratio and 4,858 were in the per-protocol population; the ClinicalTrials.gov record NCT02466737 gives 5,505.","outcomes":[{"endpoint":"Invasive disease-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"No axillary surgery","n":962,"value":91.9,"note":"95 percent confidence interval 89.9 to 93.5"},{"name":"Sentinel lymph node biopsy","n":3896,"value":91.7,"note":"95 percent confidence interval 90.8 to 92.6"}],"hr":0.91,"ci":[0.73,1.14],"source":"https://doi.org/10.1056/NEJMoa2412063"},{"endpoint":"Axillary recurrence as a first primary-outcome event","unit":"%","arms":[{"name":"No axillary surgery","n":962,"value":1},{"name":"Sentinel lymph node biopsy","n":3896,"value":0.3}],"source":"https://doi.org/10.1056/NEJMoa2412063"}],"replication":"SOUND reached the same conclusion in 1,405 patients with tumours up to 2 cm and a negative axillary ultrasound."},{"id":"insight-gist","kind":"trial","name":"INSIGHT","aka":[],"tldr":"A blood-test-selected trial testing whether matching the drug to the specific resistance mutation beats the standard second-line drug.","summary":"INSIGHT, trial NCT05734105 sponsored by Deciphera and Ono, is a blood-test-selected trial testing whether matching the drug to the specific resistance mutation beats the standard second-line drug in gastrointestinal stromal tumour, comparing ripretinib with sunitinib in patients whose circulating tumour DNA shows KIT exon 11 plus exon 17 or 18 mutations. It builds on an exploratory finding in INTRIGUE that this genotype responded far better to ripretinib, plans to enrol 54 patients, lists primary completion for 2027 and has published no primary readout. OnCo links it to sarcomas and GIST, liquid biopsy, KIT as a target, ripretinib and the pairing of ctDNA KIT genotyping with kinase inhibitor selection. It is the first ctDNA-genotype-directed randomised trial in GIST, and whether such a small trial can be decisive is the open question.","status":"active","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05734105","url":"https://clinicaltrials.gov/study/NCT05734105"}],"tags":[],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":["liquid-biopsy"],"targets":["kit"],"drugs":["ripretinib"],"companies":["deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05734105","phase":"3","setting":"Second-line GIST with KIT exon 11 + exon 17/18 mutations (ctDNA-selected): ripretinib vs sunitinib","sponsor":"Deciphera / Ono","started":"2023-12-13","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"insite","kind":"trial","name":"INSITE","aka":["CL0007","Investigation of Novel Surgical Imaging for Tumor Excision","LUM Imaging System pivotal"],"tldr":"In the study behind Lumisight's approval, scanning the lumpectomy cavity with a fluorescent dye found cancer left behind by standard surgery in about one patient in thirteen and spared some women a second operation, with few false signals but a modest hit rate on individual margins.","summary":"INSITE (NCT03686215; organisation id CL0007) was the Lumicell-sponsored prospective multicentre pivotal trial of pegulicianine fluorescence-guided surgery with the LUM Imaging System for residual cancer in the breast lumpectomy cavity, run with National Cancer Institute support at 14 US sites. Women with stage 0 to 3 breast cancer received 1.0 mg/kg intravenous pegulicianine before lumpectomy and were randomly assigned 10:1 to fluorescence-guided surgery or a control group; the randomisation existed to stop surgeons taking smaller than standard lumpectomies in anticipation of the imaging, not to provide a powered control arm for device performance. In the imaging group, additional cavity margins were excised wherever the dye signalled. The three coprimary endpoints were the percentage of patients whose guided margins contained cancer, per-margin sensitivity and per-margin specificity.\n\nIn the NEJM Evidence 2023 report, 406 patients received pegulicianine and 392 were randomised (316 invasive, 76 in situ cancers). Among 357 patients who had fluorescence-guided surgery, guided margins removed tumour left behind after standard lumpectomy in 27 (22 from cavity orientations that standard margin evaluation had called negative). Second surgeries were avoided in 9 of 62 patients with positive margins. Per-margin specificity was 85.2 percent and sensitivity 49.3 percent. Pegulicianine was stopped for adverse events in six patients, and two had grade 3 serious adverse events related to it. The trial met its prespecified thresholds for residual tumour removal and specificity but not for sensitivity.\n\nThe FDA approved pegulicianine (Lumisight) in April 2024 as an adjunct for intraoperative detection of residual cancer after lumpectomy. ClinicalTrials.gov lists the trial as a completed phase 3 with 406 participants, matching the paper's treated cohort.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03686215","url":"https://clinicaltrials.gov/study/NCT03686215"},{"label":"NEJM Evidence 2023","url":"https://doi.org/10.1056/EVIDoa2200333"}],"tags":[],"related":[],"cancers":["breast-hr-positive","tnbc","breast-her2-positive"],"sections":[],"technologies":["fluorescence-guided-surgery","optical-imaging"],"targets":[],"drugs":["pegulicianine"],"companies":["lumicell"],"institutions":[],"pathways":[],"terms":["sensitivity-specificity","lumpectomy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-smith-nejm-evid"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03686215","phase":"3","setting":"Stage 0 to 3 breast cancer undergoing lumpectomy: intravenous pegulicianine 1.0 mg/kg followed by fluorescence imaging of the cavity with the LUM Imaging System after standard excision, with extra margins taken where the dye signals","sponsor":"Lumicell","result":"Residual cancer removed by guided margins in 27 of 357 patients; per-margin specificity 85.2% and sensitivity 49.3%; second surgery avoided in 9 of 62 patients with positive margins. Residual-tumour and specificity thresholds met, sensitivity threshold not met.","started":"2019-11-04","startedType":"actual","yearReported":2023,"enrolled":406,"enrolledBasis":"registry","outcomes":[{"endpoint":"Patients in whom fluorescence-guided margins removed residual cancer after standard lumpectomy","primary":true,"unit":"patients","arms":[{"name":"Pegulicianine fluorescence-guided surgery","n":357,"value":27,"note":"27 of 357 (about 7.6%); 22 from cavity orientations called negative on standard margin evaluation; met the prespecified threshold"}],"source":"https://doi.org/10.1056/EVIDoa2200333"},{"endpoint":"Per-margin specificity","primary":true,"unit":"%","arms":[{"name":"Pegulicianine fluorescence-guided surgery","value":85.2,"note":"Met the prespecified threshold; the abstract does not give the margin denominator"}],"source":"https://doi.org/10.1056/EVIDoa2200333"},{"endpoint":"Per-margin sensitivity","primary":true,"unit":"%","arms":[{"name":"Pegulicianine fluorescence-guided surgery","value":49.3,"note":"Did not meet the prespecified threshold"}],"source":"https://doi.org/10.1056/EVIDoa2200333"},{"endpoint":"Second surgeries avoided among patients with positive margins","unit":"patients","arms":[{"name":"Pegulicianine fluorescence-guided surgery","n":62,"value":9,"note":"9 of 62 patients with positive margins"}],"source":"https://doi.org/10.1056/EVIDoa2200333"}],"replication":"No second randomised pivotal of pegulicianine has reported. Pafolacianine (Cytalux) is a different fluorescent agent for ovarian and lung surgery, and a Lumicell gastrointestinal feasibility study (NCT02584244) is a separate indication."},{"id":"int-0091","kind":"trial","name":"INT-0091 (Ewing sarcoma)","aka":[],"tldr":"Adding ifosfamide and etoposide improved cure rates for localised Ewing sarcoma, setting the backbone still used today.","summary":"INT-0091, trial NCT00002516 run by the Children's Cancer Group and the Pediatric Oncology Group and published in the New England Journal of Medicine in 2003, showed that adding ifosfamide and etoposide to vincristine, doxorubicin and cyclophosphamide improved cure rates in localised Ewing sarcoma, setting the backbone still used today. It randomised 518 patients and improved event-free survival at five years in non-metastatic disease, with no benefit in metastatic disease. OnCo links it to sarcomas, doxorubicin, ifosfamide and the Children's Oncology Group. It is the foundation of VDC/IE, which interval compression in AEWS0031 later improved, and why the same drugs fail in metastatic disease is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00002516","url":"https://clinicaltrials.gov/study/NCT00002516"}],"tags":[],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["doxorubicin","ifosfamide"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002516","phase":"3","setting":"Newly diagnosed Ewing sarcoma: VDC alone vs VDC alternating with ifosfamide-etoposide","sponsor":"Children's Cancer Group / POG","result":"5-year EFS 69% vs 54% (localised).","started":"1992-07","yearReported":2003,"enrolled":518,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 5 years (localised)","primary":true,"unit":"%","arms":[{"name":"VDC/IE","n":198,"value":69},{"name":"VDC","n":200,"value":54}],"p":"0.005","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa020890"}]},{"id":"int-0116","kind":"trial","name":"INT-0116 (Macdonald trial)","aka":[],"tldr":"The Macdonald trial made postoperative chemoradiation the US standard for resected stomach cancer in 2001, though later trials with better surgery and chemotherapy have largely replaced it.","summary":"INT-0116 randomised 556 patients after resection of stomach or junctional adenocarcinoma to observation or fluorouracil-leucovorin with 45 Gy radiotherapy. Median overall survival was 36 months with chemoradiation and 27 months with surgery alone (hazard ratio 0.74), and relapse-free survival improved (Macdonald and colleagues, New England Journal of Medicine 2001). Criticism centred on the limited lymph node surgery in most patients; with adequate D2 dissection (ARTIST, CRITICS) the added value of radiotherapy was not confirmed, and perioperative chemotherapy is now the usual approach.","status":"positive","asOf":"2026-09-17","links":[{"label":"NEJM 2001","url":"https://doi.org/10.1056/NEJMoa010187"}],"tags":["radiation-wave4"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["fluorouracil","leucovorin"],"companies":["swog"],"institutions":[],"pathways":[],"terms":["chemoradiation"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-macdonald-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Resected gastric or gastro-oesophageal junction adenocarcinoma: postoperative fluorouracil-leucovorin with 45 Gy radiotherapy versus observation","sponsor":"Southwest Oncology Group (US Intergroup)","result":"Median overall survival 36 vs 27 months (hazard ratio 0.74).","yearReported":2001,"enrolled":556,"enrolledBasis":"registry","outcomes":[{"endpoint":"Median overall survival","primary":true,"unit":"months","arms":[{"name":"Chemoradiation","n":281,"value":36},{"name":"Surgery alone","n":275,"value":27}]}]},{"id":"intellance-1","kind":"trial","name":"INTELLANCE-1","aka":["Intellance1","M13-813"],"tldr":"INTELLANCE-1 tested an antibody-drug conjugate that targets the EGFR amplification found in about half of glioblastomas, added to standard treatment; it did not help people live longer, and the drug was abandoned.","summary":"Depatuxizumab mafodotin (ABT-414) is an antibody against a conformation of EGFR exposed on amplified or mutant tumour cells, linked to the microtubule toxin monomethyl auristatin F. INTELLANCE-1 randomised 691 patients with newly diagnosed glioblastoma and EGFR amplification to standard radiotherapy and temozolomide with depatuxizumab mafodotin or placebo. The primary endpoint was overall survival.\n\nAn interim analysis found no overall survival benefit and the trial was stopped for futility, although progression-free survival had favoured the drug. Corneal toxicity affected most treated patients. The programme was discontinued, and glioblastoma remains without an effective targeted therapy despite EGFR alterations in half of tumours.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02573324","url":"https://clinicaltrials.gov/study/NCT02573324"}],"tags":["subtype-trials"],"related":[],"cancers":["glioblastoma","brain-tumours"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["depatuxizumab-mafodotin","temozolomide"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["andrew-lassman"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02573324","phase":"3","setting":"Newly diagnosed glioblastoma with EGFR amplification: radiotherapy and temozolomide with depatuxizumab mafodotin or placebo","sponsor":"AbbVie","result":"Depatuxizumab mafodotin added to radiotherapy and temozolomide did not improve overall survival in EGFR-amplified glioblastoma; stopped for futility.","started":"2015-01-04","startedType":"actual","yearReported":2019,"enrolled":691,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (registry results)","primary":true,"unit":"months","arms":[{"name":"Depatuxizumab mafodotin + radiotherapy + temozolomide","value":18.9,"note":"95% CI 17.4 to 20.8; median follow-up 15.5 months"},{"name":"Placebo + radiotherapy + temozolomide","value":18.7,"note":"95% CI 17.0 to 20.3"}],"hr":1.02,"ci":[0.82,1.26],"p":"0.633","source":"https://clinicaltrials.gov/study/NCT02573324?tab=results"}]},{"id":"inter-b-nhl-ritux-2010","kind":"trial","name":"Inter-B-NHL Ritux 2010","aka":[],"tldr":"Adding the antibody rituximab to intensive chemotherapy in children with high-risk Burkitt and related lymphomas cut treatment failures by about two-thirds, making an already curable disease more so. It is the model of a joint European-North American children's cancer trial.","summary":"Open-label international randomised phase 3 (Minard-Colin et al., NEJM 2020). Among 328 randomised patients (164 per arm; 85.7% Burkitt lymphoma), events occurred in 10 with rituximab-chemotherapy versus 28 with chemotherapy alone. Three-year event-free survival was 93.9% (95% CI 89.1 to 96.7) versus 82.3% (95% CI 75.7 to 87.5), HR 0.32 (95% CI 0.15 to 0.66), and overall survival also improved. Randomisation was stopped early for efficacy and all subsequent patients received rituximab. Rituximab roughly doubled the rate of hypogammaglobulinaemia and increased infections, so immune monitoring is part of follow-up. Rituximab plus LMB is now the standard for high-risk paediatric mature B-cell lymphoma on both sides of the Atlantic and formed the basis of the 2021 FDA paediatric label extension for rituximab.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT01516580","url":"https://clinicaltrials.gov/study/NCT01516580"},{"label":"Minard-Colin et al., NEJM 2020","url":"https://doi.org/10.1056/NEJMoa1915315"}],"tags":["nci-coverage","paediatric","haematologic"],"related":[],"cancers":["burkitt-lymphoma","dlbcl"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["cd20"],"drugs":["rituximab","methotrexate","cyclophosphamide","doxorubicin","vincristine","cytarabine-7-3","etoposide"],"companies":["childrens-oncology-group"],"institutions":["gustave-roussy","siop-europe"],"pathways":[],"terms":["hypogammaglobulinaemia"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-minard-colin-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01516580","phase":"3","setting":"High-risk mature B-cell non-Hodgkin lymphoma or B-acute leukaemia in patients under 18 (mostly Burkitt lymphoma): LMB chemotherapy with or without six doses of rituximab","sponsor":"Gustave Roussy (European Intergroup for Childhood NHL) and Children's Oncology Group","result":"3-year EFS 93.9% vs 82.3%, HR 0.32; OS also improved.","started":"2011-12","startedType":"actual","yearReported":2020,"enrolled":482,"enrolledBasis":"registry","outcomes":[{"endpoint":"3-year event-free survival","primary":true,"unit":"%","arms":[{"name":"Rituximab + LMB chemotherapy","n":164,"value":93.9},{"name":"LMB chemotherapy","n":164,"value":82.3}],"hr":0.32,"ci":[0.15,0.66],"p":"0.00096 (one-sided)","source":"https://doi.org/10.1056/NEJMoa1915315"}],"replication":"Consistent with the adult experience of rituximab in aggressive B-cell lymphoma (CODOX-M/IVAC-R, DA-EPOCH-R) and with the earlier COG ANHL01P1 pilot; no contradicting paediatric data."},{"id":"interaact","kind":"trial","name":"InterAACT","aka":["InterAAct","IRCI InterAACT","EA2133"],"tldr":"InterAACT was the first randomised trial ever run in advanced anal cancer; the two chemotherapy pairs shrank tumours equally often, but carboplatin with paclitaxel caused far fewer serious side effects and patients on it lived longer, so it became the standard chemotherapy backbone.","summary":"InterAACT was an international randomised phase 2 trial of the International Rare Cancers Initiative, led from the Royal Marsden with ECOG-ACRIN, AGITG and EORTC partners, in 91 patients with chemotherapy-naive advanced anal squamous cell carcinoma randomised to cisplatin plus fluorouracil or carboplatin plus weekly paclitaxel. The primary endpoint was best overall response rate by 24 weeks.\n\nResponse rates were the same (57 against 59 percent), but serious adverse events were more frequent with cisplatin-fluorouracil (62 against 36 percent), median progression-free survival was 5.7 against 8.1 months and median overall survival 12.3 against 20 months (hazard ratio 2.00 for cisplatin-fluorouracil). Carboplatin-paclitaxel became the reference regimen and the chemotherapy backbone of POD1UM-303, which is how the corpus's metastatic anal cancer page cites it.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02051868","url":"https://clinicaltrials.gov/study/NCT02051868"},{"label":"ClinicalTrials.gov NCT02560298","url":"https://clinicaltrials.gov/study/NCT02560298"}],"tags":["soc-trials"],"related":[],"cancers":["metastatic-anal-cancer","anal"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["carboplatin","paclitaxel","cisplatin","fluorouracil"],"companies":["ecog-acrin"],"institutions":["royal-marsden"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-interaact-carboplatin-paclitaxel-advanced-anal-cancer-rao-jco-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02051868","phase":"2","setting":"Chemotherapy-naive inoperable locally recurrent or metastatic anal squamous cell carcinoma at 60 centres through the International Rare Cancers Initiative: cisplatin plus fluorouracil against carboplatin plus weekly paclitaxel, with best overall response rate by 24 weeks as the primary endpoint","sponsor":"Royal Marsden NHS Foundation Trust","result":"Response rate 57 percent with cisplatin-fluorouracil against 59 percent with carboplatin-paclitaxel; serious adverse events 62 against 36 percent; median overall survival 12.3 against 20 months (hazard ratio 2.00, p 0.014).","started":"2013-12","yearReported":2020,"enrolled":91,"enrolledBasis":"randomised","enrolledNote":"The UK registry record gives an estimated 80 and the ECOG-ACRIN companion record (NCT02560298, EA2133) 91; the Journal of Clinical Oncology report randomised 91 patients across both (46 to cisplatin-fluorouracil, 45 to carboplatin-paclitaxel).","outcomes":[{"endpoint":"Best overall response rate by 24 weeks","primary":true,"unit":"%","arms":[{"name":"Carboplatin + weekly paclitaxel","n":45,"value":59,"note":"95% CI 42.1 to 74.4"},{"name":"Cisplatin + fluorouracil","n":46,"value":57,"note":"95% CI 39.4 to 73.7"}],"source":"https://doi.org/10.1200/JCO.19.03266"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Carboplatin + weekly paclitaxel","n":45,"value":20,"note":"95% CI 12.7 to not reached"},{"name":"Cisplatin + fluorouracil","n":46,"value":12.3,"note":"95% CI 9.2 to 17.7"}],"hr":2,"ci":[1.15,3.47],"p":"0.014","source":"https://doi.org/10.1200/JCO.19.03266"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Carboplatin + weekly paclitaxel","n":45,"value":8.1,"note":"95% CI 6.6 to 8.8"},{"name":"Cisplatin + fluorouracil","n":46,"value":5.7,"note":"95% CI 3.3 to 9.0"}],"source":"https://doi.org/10.1200/JCO.19.03266"},{"endpoint":"Serious adverse events","unit":"%","arms":[{"name":"Carboplatin + weekly paclitaxel","n":45,"value":36},{"name":"Cisplatin + fluorouracil","n":46,"value":62}],"p":"0.016","source":"https://doi.org/10.1200/JCO.19.03266"}]},{"id":"nct06123156","kind":"trial","name":"Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer","aka":["RECTIL"],"tldr":"A phase 3 trial in colorectal cancer, run by University Hospital, Rouen, now recruiting.","summary":"Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer is a phase 3, randomised interventional study registered as NCT06123156 by University Hospital, Rouen, with a registry enrolment figure of 188 participants, started 2025-09-25 and due to reach its primary completion in 2030-02. Interventions recorded: Sildenafil; Placebo. Conditions listed: Rectal Cancer. Primary outcome: the patient's response. Colorectal eligibility wording from the registry: \"* Patients undergoing surgery for cancer of the lower or middle rectum by total removal of the mesorectum with colorectal or coloanal anastomosis after neoadjuvant radiotherapy, with normal preoperative erectile function (defined by a combined IIEF erectile function domain score of at least 22)\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06123156","url":"https://clinicaltrials.gov/study/NCT06123156"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06123156","phase":"3","setting":"Intérêt de la rééducation érectile précoce Par Sildénafil après radiothérapie et Proctectomie Pour Cancer du Rectum : Essai contrôlé randomisé","sponsor":"University Hospital, Rouen","started":"2025-09-25","startedType":"actual","enrolled":188,"enrolledBasis":"registry","outcomes":[]},{"id":"interfant-06","kind":"trial","name":"Interfant-06","aka":[],"tldr":"The largest infant leukaemia trial showed that intensifying chemotherapy did not help, and set the stage for adding blinatumomab instead.","summary":"651 infants; 6-year EFS 46.1% overall, no benefit from myeloid-style intensification; KMT2A rearrangement (in ~75%) remained the dominant adverse factor. JCO 2019. The follow-on Interfant-21 adds blinatumomab after a pilot (NEJM 2023) showed 2-year DFS 81.6% vs 49.4% historical, and menin inhibitors are entering infant ALL trials.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00550992","url":"https://clinicaltrials.gov/study/NCT00550992"}],"tags":[],"related":[],"cancers":["all-leukemia","all-infant"],"sections":[],"technologies":["t-cell-engager"],"targets":["kmt2a"],"drugs":["blinatumomab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00550992","phase":"3","setting":"Infant ALL (<1 year): standard vs AML-type early intensification; transplant for high-risk KMT2A-rearranged infants","sponsor":"Interfant consortium","result":"6-year EFS 46.1%; intensification no benefit.","started":"2006-01","startedType":"actual","yearReported":2019,"enrolled":651,"enrolledBasis":"registered","enrolledNote":"ClinicalTrials.gov lists an estimated 445 participants and the record's status is unknown, meaning the sponsor has not verified it recently; the JCO 2019 paper reports 651 infants included.","outcomes":[{"endpoint":"Event-free survival at 6 years","primary":true,"unit":"%","arms":[{"name":"All infants","n":651,"value":46.1}],"source":"https://ascopubs.org/doi/10.1200/JCO.19.00261"}],"replication":"COG AALL0631 reported similar EFS, confirming a plateau for chemotherapy-only approaches in infant ALL."},{"id":"turrisi-intergroup-0096","kind":"trial","name":"Intergroup 0096 (Turrisi): twice-daily versus once-daily thoracic radiotherapy","aka":["INT 0096","Turrisi trial"],"tldr":"Showed that giving the same dose of radiotherapy twice a day for three weeks, rather than once a day for five, raises the five-year survival of limited-stage small-cell lung cancer from 16 to 26 percent.","summary":"Thoracic radiotherapy was known to improve survival in limited-stage small-cell lung cancer, but how to fit it around chemotherapy was unsettled. Intergroup 0096 gave all 417 patients four 21-day cycles of cisplatin and etoposide and randomised them to 45 Gy of concurrent thoracic radiotherapy given either twice daily over three weeks or once daily over five, both starting with cycle 1.\n\nAfter a median follow-up of almost eight years, median survival was 23 months with twice-daily treatment against 19 months with once-daily (log-rank p=0.04). Two-year survival was 47 against 41 percent and five-year survival 26 against 16 percent. Grade 3 oesophagitis was the price: 27 percent against 11 percent.\n\nThe combined two- and five-year survival of 44 and 23 percent was a considerable advance on the previous literature, and twice-daily 45 Gy has been a standard ever since, although many centres use 60 to 66 Gy once daily instead because CONVERT, which compared 45 Gy twice daily with 66 Gy once daily in 547 patients, found no significant survival difference and similar toxicity.","status":"positive","asOf":"2026-09-25","links":[{"label":"Intergroup 0096 (New England Journal of Medicine 1999)","url":"https://doi.org/10.1056/NEJM199901283400403"}],"tags":[],"related":[],"cancers":["limited-stage-sclc"],"sections":[],"technologies":["imrt-igrt","hypofractionated-radiotherapy","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin","etoposide","platinum-etoposide"],"companies":[],"institutions":[],"pathways":[],"terms":["chemoradiation","curative-intent"],"trials":["convert","adriatic"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Limited-stage small-cell lung cancer: 45 Gy of concurrent thoracic radiotherapy delivered twice daily over three weeks versus once daily over five weeks, both starting with cycle 1 of four cycles of cisplatin and etoposide, with overall survival as the primary endpoint","sponsor":"Eastern Cooperative Oncology Group and the North American intergroup","result":"Median survival 23 against 19 months (p=0.04); five-year survival 26 against 16 percent; grade 3 oesophagitis 27 against 11 percent.","yearReported":1999,"enrolled":417,"enrolledBasis":"randomised","enrolledNote":"417 patients were randomised; the trial predates ClinicalTrials.gov registration.","outcomes":[{"endpoint":"Overall survival at 5 years","primary":true,"unit":"%","arms":[{"name":"45 Gy twice daily over 3 weeks","value":26},{"name":"45 Gy once daily over 5 weeks","value":16}],"p":"0.04","source":"https://doi.org/10.1056/NEJM199901283400403"},{"endpoint":"Grade 3 oesophagitis","unit":"%","arms":[{"name":"45 Gy twice daily over 3 weeks","value":27},{"name":"45 Gy once daily over 5 weeks","value":11}],"source":"https://doi.org/10.1056/NEJM199901283400403"}],"replication":"CONVERT found 45 Gy twice daily and 66 Gy once daily gave similar survival and toxicity, so both schedules are used."},{"id":"interlace","kind":"trial","name":"INTERLACE","aka":[],"tldr":"Six weeks of cheap, generic chemotherapy before standard chemoradiation cut deaths by 40%, an advance usable anywhere in the world.","summary":"INTERLACE, trial NCT01566240 sponsored by the UCL Cancer Trials Centre and Cancer Research UK and published in the Lancet in 2024, showed that six weeks of cheap, generic carboplatin and paclitaxel before standard chemoradiation for locally advanced cervical cancer cut deaths by forty percent, an advance usable anywhere in the world. It randomised 500 patients across 32 centres in five countries including India and Mexico and met its primary progression-free and overall survival endpoints at five years. Earlier neoadjuvant trials before surgery were negative, so this short induction before radiation is a distinct strategy not yet reproduced, and it is the pragmatic choice where pembrolizumab is unaffordable.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01566240","url":"https://clinicaltrials.gov/study/NCT01566240"},{"label":"Lancet 2024","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01438-7/fulltext"}],"tags":[],"related":[],"cancers":["cervical","locally-advanced-cervical-cancer"],"sections":[],"technologies":["imrt-igrt","brachytherapy","cytotoxic-chemotherapy"],"targets":[],"drugs":["carboplatin","paclitaxel","cisplatin"],"companies":[],"institutions":["cruk"],"pathways":[],"terms":[],"trials":[],"people":["mary-mccormack"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01566240","phase":"3","setting":"Locally advanced cervical cancer: 6 weeks of induction carboplatin-paclitaxel before chemoradiation vs chemoradiation alone","sponsor":"UCL Cancer Trials Centre / CRUK","result":"5-year OS 80% vs 72% (HR 0.60); PFS HR 0.65.","started":"2012-11-08","startedType":"actual","yearReported":2023,"enrolled":500,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Induction chemo + CRT","n":250,"value":72},{"name":"CRT alone","n":250,"value":64}],"hr":0.65,"ci":[0.46,0.91],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01438-7/fulltext"},{"endpoint":"Overall survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Induction chemo + CRT","value":80},{"name":"CRT alone","value":72}],"hr":0.6,"ci":[0.4,0.91],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01438-7/fulltext"}],"replication":"Earlier neoadjuvant chemotherapy trials before surgery (EORTC 55994) were negative; INTERLACE's short weekly induction before radiation is a distinct strategy not yet reproduced."},{"id":"nct00493181","kind":"trial","name":"Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients","aka":[],"tldr":"A phase 2 trial of Oprelvekin in Leukaemia and Chronic myeloid leukaemia, run by M.D. Anderson Cancer Center, completed.","summary":"Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients is a phase 2 interventional study registered as NCT00493181 by M.D. Anderson Cancer Center, with 8 participants recorded, started 2005-10 and reaching its primary completion in 2011-01. Interventions recorded: Interleukin-11 (IL-11 or Neumega). Conditions recorded: Leukemia, Chronic Myelogenous Leukemia, Chronic Myeloid Leukemia.\n\nLinked to the drug Oprelvekin because the registry names it among its interventions and Leukaemia and Chronic myeloid leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00493181","url":"https://clinicaltrials.gov/study/NCT00493181"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia","cml"],"sections":[],"technologies":[],"targets":[],"drugs":["oprelvekin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00493181","phase":"2","setting":"The Effect of Interleukin 11 on Thrombocytopenia Associated With Imatinib or Other Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myelogenous Leukemia","sponsor":"M.D. Anderson Cancer Center","started":"2005-10","yearReported":2011,"enrolled":8,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Complete Response","primary":true,"unit":"participants","arms":[{"name":"Interleukin-11","n":8,"value":3,"note":"Figures from the ClinicalTrials.gov results section (first posted 2011-05-04), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00493181?tab=results"}]},{"id":"nct00004157","kind":"trial","name":"Interleukin-11 Plus Filgrastim Prior to Peripheral Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease, Breast Cancer, or Other Solid Tumors","aka":[],"tldr":"A phase 2 trial of Filgrastim and Oprelvekin in Breast cancer, Neuroblastoma and Ovarian cancer, run by Fred Hutchinson Cancer Center, completed.","summary":"Interleukin-11 Plus Filgrastim Prior to Peripheral Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease, Breast Cancer, or Other Solid Tumors is a phase 2 interventional study registered as NCT00004157 by Fred Hutchinson Cancer Center, started 2000-08 and reaching its primary completion in 2002-04. Interventions recorded: filgrastim, recombinant interleukin-11. Conditions recorded: Breast Cancer, Gestational Trophoblastic Tumor, Kidney Cancer, Lymphoma, Neuroblastoma, Ovarian Cancer, Sarcoma, Testicular Germ Cell Tumor.\n\nLinked to the drug Oprelvekin because the registry names it among its interventions and Breast cancer, Neuroblastoma and Ovarian cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00004157","url":"https://clinicaltrials.gov/study/NCT00004157"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer","neuroblastoma","ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["filgrastim","oprelvekin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00004157","phase":"2","setting":"Combination of Interleukin 11 (Neumega) With G-CSF to Mobilize Autologous Peripheral Blood Stem Cells (PBSC)","sponsor":"Fred Hutchinson Cancer Center","started":"2000-08","enrolledBasis":"registry","outcomes":[]},{"id":"nct06509126","kind":"trial","name":"Intermittent or Continuous Panitumumab Plus FOLFIRI for Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer","aka":["IMPROVE-2"],"tldr":"A phase 3 trial of panitumumab, fOLFIRI (5-FU, leucovorin, irinotecan) and fluorouracil (5-FU) in colorectal cancer, run by National Cancer Institute, Naples, now recruiting.","summary":"Intermittent or Continuous Panitumumab Plus FOLFIRI for Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT06509126 by National Cancer Institute, Naples, with a registry enrolment figure of 500 participants, started 2024-06-12 and due to reach its primary completion in 2028-01. Interventions recorded: Panitumumab; Irinotecan; 5-fluorouracil; L-folinic acid. Conditions listed: Colorectal Cancer Stage IV. Primary outcome: Time to Treatment Failure. Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06509126","url":"https://clinicaltrials.gov/study/NCT06509126"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["panitumumab","folfiri","fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06509126","phase":"3","setting":"Randomized Phase 3 Study of Intermittent or Continuous Panitumumab Plus FOLFIRI for First-line Treatment of Patients With Unresectable Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer (IMPROVE-2 Trial)","sponsor":"National Cancer Institute, Naples","started":"2024-06-12","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01117441","kind":"trial","name":"International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia","aka":[],"tldr":"A phase 3 trial of Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone, Doxorubicin, Etoposide, Ifosfamide, Mercaptopurine, Methotrexate, Prednisone, Thioguanine, Vincristine, Vindesine and Fludarabine in Leukaemia, run by University Hospital Schleswig-Holstein, completed.","summary":"International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia is a phase 3 interventional study registered as NCT01117441 by University Hospital Schleswig-Holstein, with 6136 participants recorded, started 2010-06 and reaching its primary completion in 2021-12-31. Interventions recorded: PEG-L-asparaginase, cyclophosphamide, cytarabine, daunorubicin hydrochloride, dexamethasone, doxorubicin hydrochloride, etoposide, ifosfamide, mercaptopurine, methotrexate, prednisone, thioguanine, vincristine sulfate, vindesine, daunoxome, fludarabine, Radiation Therapy. Conditions recorded: Leukemia.\n\nLinked to the drug Vindesine because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01117441","url":"https://clinicaltrials.gov/study/NCT01117441"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["cyclophosphamide","cytarabine","daunorubicin","dexamethasone","doxorubicin","etoposide","ifosfamide","mercaptopurine","methotrexate","prednisone","thioguanine","vincristine","vindesine","fludarabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01117441","phase":"3","setting":"International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia","sponsor":"University Hospital Schleswig-Holstein","started":"2010-06","enrolled":6136,"enrolledBasis":"registry","outcomes":[]},{"id":"iwwd","kind":"trial","name":"International Watch & Wait Database","aka":["IWWD"],"tldr":"The worldwide register of people who kept their rectum after treatment. A quarter of the cancers regrow, almost all within two years and almost all in the bowel wall where they can be found and removed.","summary":"The International Watch & Wait Database pooled individual patient data from 47 institutes in 15 countries for people whose rectal cancer was managed without surgery after a clinical complete response to neoadjuvant treatment. Of 1,009 patients identified, 880 had a clinical complete response. The two-year cumulative incidence of local regrowth was 25.2 percent (95% CI 22.2 to 28.5); 88 percent of regrowth appeared in the first two years and 97 percent was in the bowel wall, where endoscopic surveillance finds it and salvage surgery is possible. Distant metastases occurred in 8 percent. Five-year overall survival was 85 percent and disease-specific survival 94 percent. The registry is the evidence base for offering watch and wait outside a trial and sets the surveillance schedule: endoscopy and MRI every three to four months for two years.","status":"active","asOf":"2026-09-24","links":[{"label":"IWWD: long-term outcomes of clinical complete responders after neoadjuvant treatment for rectal cancer (Lancet 2018)","url":"https://doi.org/10.1016/S0140-6736(18)31078-X"},{"label":"International Watch & Wait Database","url":"https://www.iwwd.org/"}],"tags":[],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["clinical-complete-response","pcr","chemoradiation"],"trials":["opra","azur-1"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"observational","setting":"Rectal cancer with a clinical complete response after neoadjuvant treatment: no surgery, with endoscopic and MRI surveillance, pooled from 47 institutes in 15 countries","sponsor":"European Registration of Cancer Care / European Society of Surgical Oncology","result":"Two-year local regrowth 25.2 percent, 97 percent of it in the bowel wall; five-year overall survival 85 percent, disease-specific survival 94 percent.","yearReported":2018,"enrolled":1009,"enrolledBasis":"registered","enrolledNote":"1,009 patients managed by watch and wait were identified in the registry by June 2017, of whom 880 had a clinical complete response; the registry is not a trial and has no NCT number.","outcomes":[{"endpoint":"Cumulative local regrowth at 2 years","primary":true,"unit":"percent","arms":[{"name":"Watch and wait after clinical complete response","n":880,"value":25.2}],"ci":[22.2,28.5],"source":"https://doi.org/10.1016/S0140-6736(18)31078-X"},{"endpoint":"Overall survival at 5 years","unit":"percent","arms":[{"name":"Watch and wait after clinical complete response","n":880,"value":85}],"source":"https://doi.org/10.1016/S0140-6736(18)31078-X"}]},{"id":"interpath-001","kind":"trial","name":"INTerpath-001 (V940-001)","aka":[],"tldr":"INTerpath-001 was the first positive phase 3 trial of a personalised cancer vaccine, announced 19 August 2026.","summary":"INTerpath-001, also V940-001, trial NCT05933577 sponsored by Moderna and Merck and announced on 19 August 2026, was the first positive phase 3 trial of a personalised cancer vaccine, testing intismeran autogene plus pembrolizumab against pembrolizumab alone after resection of stage IIB to IV melanoma. It randomised 1,137 patients, met its primary recurrence-free survival endpoint and its key secondary distant metastasis-free survival endpoint with no new safety signals, and full data are expected at a late-2026 congress with filings to follow; sister trials run in lung, kidney, bladder and skin squamous cancers. It confirms the phase 2b KEYNOTE-942 signal, and whether the effect size justifies bespoke manufacturing for every patient is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05933577","url":"https://clinicaltrials.gov/study/NCT05933577"},{"label":"Merck press release","url":"https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath-001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrence-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/"}],"tags":[],"related":[],"cancers":["melanoma","stage-iii-melanoma","stage-ii-melanoma"],"sections":[],"technologies":["neoantigen-mrna-vaccine"],"targets":[],"drugs":["intismeran-autogene","pembrolizumab"],"companies":["moderna"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jeffrey-weber"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05933577","phase":"3","setting":"Adjuvant resected stage IIB-IV melanoma: intismeran autogene + pembrolizumab vs pembrolizumab","sponsor":"Moderna / Merck","result":"RFS and DMFS significantly improved (HRs pending presentation).","started":"2023-07-19","startedType":"actual","yearReported":2026,"enrolled":1137,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free survival","primary":true,"arms":[{"name":"Intismeran autogene + pembrolizumab","note":"Met; hazard ratio and medians not yet disclosed (topline 19 August 2026)."},{"name":"Placebo + pembrolizumab"}],"source":"https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath-001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrence-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/"},{"endpoint":"Distant metastasis-free survival","arms":[{"name":"Intismeran autogene + pembrolizumab","note":"Met; numbers pending presentation."},{"name":"Placebo + pembrolizumab"}]}],"replication":"Confirms the phase 2b KEYNOTE-942 signal (RFS HR 0.51 at 3 years) in a randomised phase 3; full data pending."},{"id":"nct01415986","kind":"trial","name":"Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers","aka":[],"tldr":"A phase 2 trial of Temoporfin in Head and neck squamous cell carcinoma, run by University of Arkansas, recorded as terminated on the registry.","summary":"Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers is a phase 2 interventional study registered as NCT01415986 by University of Arkansas, with 1 participants recorded, started 2010-11 and due to reach its primary completion in 2011-08. Interventions recorded: Temoporfin, Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH). Conditions recorded: Squamous Cell Carcinoma of the Head and Neck.\n\nLinked to the drug Temoporfin because the registry names it among its interventions and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01415986","url":"https://clinicaltrials.gov/study/NCT01415986"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":["temoporfin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01415986","phase":"2","setting":"Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers - PHASE II PILOT STUDY","sponsor":"University of Arkansas","started":"2010-11","enrolled":1,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06478108","kind":"trial","name":"Interventional Software for Multi-immunotherapy of Solid Tumors","aka":[],"tldr":"A phase 2/3 trial in lung cancer, run by Second Affiliated Hospital of Guangzhou Medical University, now recruiting.","summary":"Interventional Software for Multi-immunotherapy of Solid Tumors is a phase 2/3, interventional study registered as NCT06478108 by Second Affiliated Hospital of Guangzhou Medical University, with a registry enrolment figure of 60 participants, started 2024-04-01 and due to reach its primary completion in 2028-12-30. Interventions recorded: IRSW-MIM. Conditions listed: Lung Cancer; Liver Cancer; Solid Tumor, Adult. Primary outcome: Safety of the reccommended treatment generated by the medical device; Progression-free survival; Disease control rate. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06478108","url":"https://clinicaltrials.gov/study/NCT06478108"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06478108","phase":"2/3","setting":"Interventional Software IRSW-MIM Guided Immunotherapy for Advanced Solid Tumors: a Phase II Clinical Trial.","sponsor":"Second Affiliated Hospital of Guangzhou Medical University","started":"2024-04-01","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06793137","kind":"trial","name":"Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by AC Camargo Cancer Center, now recruiting.","summary":"Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT06793137 by AC Camargo Cancer Center, with a registry enrolment figure of 100 participants, started 2024-07-22 and due to reach its primary completion in 2025-10-31. Interventions recorded: Metronidazole. Conditions listed: Rectal Cancer, Adenocarcinoma. Primary outcome: Complete clinical response in total neoadjuvant treatment of rectal adenocarcinoma. Colorectal eligibility wording from the registry: \"* Patients over 18 years old with middle and lower rectal adenocarcinoma, classified as locally advanced or where the tumor´s location necessitates rectal amputation surgery;\". Sites: Brazil. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06793137","url":"https://clinicaltrials.gov/study/NCT06793137"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06793137","phase":"2","setting":"Phase II Trial for Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer","sponsor":"AC Camargo Cancer Center","started":"2024-07-22","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03257033","kind":"trial","name":"Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC","aka":["TIGeR-PaC"],"tldr":"A phase 3 trial of Gemcitabine in pancreatic ductal adenocarcinoma, run by RenovoRx, now recruiting.","summary":"Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC is a phase 3 interventional study registered as NCT03257033 by RenovoRx, with 190 participants planned, started 2018-03-12 and due to reach its primary completion in 2027-06. Interventions recorded: Gemcitabine, nab-paclitaxel and RenovoCath.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03257033","url":"https://clinicaltrials.gov/study/NCT03257033"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03257033","phase":"3","setting":"Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer","sponsor":"RenovoRx","started":"2018-03-12","startedType":"actual","enrolled":190,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05168839","kind":"trial","name":"Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage","aka":["FLUOCOL-1"],"tldr":"A phase 3 trial in colorectal cancer, run by Centre Hospitalier Universitaire de Besancon, now recruiting.","summary":"Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage is a phase 3, randomised interventional study registered as NCT05168839 by Centre Hospitalier Universitaire de Besancon, with a registry enrolment figure of 1010 participants, started 2022-09-26 and due to reach its primary completion in 2025-10-31. Interventions recorded: FLUO+ : Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG).. Conditions listed: Colorectal Cancer. Primary outcome: Anastomotic leakage 90 days after surgery. Colorectal eligibility wording from the registry: \"* Scheduled to undergo elective left colectomy or high rectal resection for cancer with intraperitoneal anastomosis\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05168839","url":"https://clinicaltrials.gov/study/NCT05168839"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05168839","phase":"3","setting":"Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage: a Single-blind Phase III Multicenter Randomized Controlled Trial (Intergroup FRENCH-GRECCAR Trial)","sponsor":"Centre Hospitalier Universitaire de Besancon","started":"2022-09-26","startedType":"actual","enrolled":1010,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02213991","kind":"trial","name":"Intraoperative Radiotherapy for Korean Patients With Breast Cancer","aka":[],"tldr":"A phase 2 trial of Intraoperative radiotherapy in Breast cancer, run by Gangnam Severance Hospital, with a status the registry has not verified recently.","summary":"Intraoperative Radiotherapy for Korean Patients With Breast Cancer is a phase 2 interventional study registered as NCT02213991 by Gangnam Severance Hospital, with 215 participants planned, started 2014-08 and due to reach its primary completion in 2017-10. Interventions recorded: Intraoperative radiotherapy using Intrabeam®. Conditions recorded: Breast Cancer.\n\nLinked to the technology Intraoperative radiotherapy because the registry names it (\"intraoperative radiotherapy\") among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02213991","url":"https://clinicaltrials.gov/study/NCT02213991"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["intraoperative-radiotherapy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02213991","phase":"2","setting":"A Phase II Trial Investigating Acute Local Toxicities of Intraoperative Radiotherapy as a Boost Dose in Korean Breast Cancer Patients Undergoing Breast Conserving Surgery","sponsor":"Gangnam Severance Hospital","started":"2014-08","enrolled":215,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02685605","kind":"trial","name":"Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme","aka":["INTRAGO II"],"tldr":"A phase 3 trial of Intraoperative radiotherapy in Glioma & glioblastoma, run by Universitätsmedizin Mannheim, active and no longer recruiting.","summary":"Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme is a phase 3 interventional study registered as NCT02685605 by Universitätsmedizin Mannheim, with 314 participants planned, started 2016-12-09 and due to reach its primary completion in 2025-11. Interventions recorded: Standard surgery, Intraoperative radiotherapy, Radiochemotherapy, Temozolomide. Conditions recorded: Glioblastoma.\n\nLinked to the technology Intraoperative radiotherapy because the registry names it (\"intraoperative radiotherapy\") among its interventions and Glioma & glioblastoma among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02685605","url":"https://clinicaltrials.gov/study/NCT02685605"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["intraoperative-radiotherapy"],"targets":[],"drugs":["temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02685605","phase":"3","setting":"A Multicenter Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme (INTRAGO II)","sponsor":"Universitätsmedizin Mannheim","started":"2016-12-09","startedType":"actual","enrolled":314,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05688280","kind":"trial","name":"Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS","aka":["INJECTABL-1"],"tldr":"A phase 1/2 trial of 1.0% IP-001 for Injection in colorectal cancer, non-small-cell lung cancer and sarcomas, run by Immunophotonics, Inc., active and no longer recruiting.","summary":"Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS is a phase 1/2 interventional study registered as NCT05688280 by Immunophotonics, Inc., with 42 participants enrolled, started 2022-11-29 and due to reach its primary completion in 2025-02. Interventions recorded: 1.0% IP-001 for Injection.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05688280","url":"https://clinicaltrials.gov/study/NCT05688280"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","nsclc","sarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05688280","phase":"1/2","setting":"Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors. A Multicenter Phase 1b/2a Trial in Colorectal Cancer, Non-small Cell Lung Cancer, and Soft Tissue Sarcoma Patients","sponsor":"Immunophotonics, Inc.","started":"2022-11-29","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06358573","kind":"trial","name":"Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK","aka":["INVINCIBLE-4"],"tldr":"A phase 2 trial of INT230-6 in triple-negative breast cancer, run by Swiss Cancer Institute, now recruiting.","summary":"Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK is a phase 2, randomised interventional study registered as NCT06358573 by Swiss Cancer Institute, with a registry enrolment figure of 61 participants, started 2024-10-24 and due to reach its primary completion in 2028-10. Interventions recorded: INT230-6; neoadjuvant immuno-chemotherapy. Conditions listed: Triple-negative Breast Cancer; TNBC - Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Newly histologically diagnosed, previously untreated locally advanced non-metastatic TNBC as defined by the most recent American Society of Clinical Oncology (ASCO) / College of American Pathologist (CAP) guidelines\". Sites: France, Switzerland. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06358573","url":"https://clinicaltrials.gov/study/NCT06358573"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["int230-6"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06358573","phase":"2","setting":"Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early Triple-negative Breast Cancer (TNBC). An Open-label Randomized Two-cohort Phase 2 Clinical Trial. INVINCIBLE-4-SAKK","sponsor":"Swiss Cancer Institute","started":"2024-10-24","startedType":"actual","enrolled":61,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07539155","kind":"trial","name":"Intratumoral MMR Vaccine Injection in Borderline Resectable/Unresectable Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by University of Arkansas, now recruiting.","summary":"Intratumoral MMR Vaccine Injection in Borderline Resectable/Unresectable Pancreatic Cancer is a phase 1/2, interventional study registered as NCT07539155 by University of Arkansas, with a registry enrolment figure of 20 participants, started 2026-06-26 and due to reach its primary completion in 2028-08. Interventions recorded: Intratumoral MMR Injection. Conditions listed: Borderline Resectable/Unresectable Pancreatic Cancer; Non Metastatic Pancreatic Cancer. Primary outcome: Intratumoral T-Cell Response. Pancreatic eligibility wording from the registry: \"Pathologically proven locally advanced adenocarcinoma of pancreas\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07539155","url":"https://clinicaltrials.gov/study/NCT07539155"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["shared-antigen-vaccine"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07539155","phase":"1/2","setting":"Phase 1b/2 Study of Intratumoral MMR Vaccine Injection in Borderline Resectable/Unresectable Pancreatic Cancer","sponsor":"University of Arkansas","started":"2026-06-26","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07339176","kind":"trial","name":"Intratumoral N17350 in Advanced Solid Tumors","aka":["OP-NEU-101"],"tldr":"A phase 1/2 trial of N17350 in melanoma, head and neck squamous cell carcinoma and non-small-cell lung cancer, run by Onchilles Pharma Inc, now recruiting.","summary":"Intratumoral N17350 in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07339176 by Onchilles Pharma Inc, with 275 participants planned, started 2026-05-25 and due to reach its primary completion in 2028-07. Interventions recorded: N17350.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07339176","url":"https://clinicaltrials.gov/study/NCT07339176"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","head-and-neck","nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07339176","phase":"1/2","setting":"A Phase 1/2 Open-Label, Dose Finding and Expansion Study to Investigate the Safety and Effectiveness and Determination of the Optimal Dose of N17350 Administered Intratumorally in Participants With Advanced Solid Tumors","sponsor":"Onchilles Pharma Inc","started":"2026-05-25","startedType":"actual","enrolled":275,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06898970","kind":"trial","name":"Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab for Angiosarcoma","aka":[],"tldr":"A phase 2 trial of Vusolimogene oderparepvec and Pembrolizumab in Angiosarcoma, run by Varun Monga, MBBS, now recruiting.","summary":"Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab for Angiosarcoma is a phase 2 interventional study registered as NCT06898970 by Varun Monga, MBBS, with 18 participants planned, started 2026-01-09 and due to reach its primary completion in 2029-10-31. Interventions recorded: Vusolimogene Oderparepvec (VO), Pembrolizumab. Conditions recorded: Angiosarcoma, Angiosarcoma, Adult.\n\nLinked to the drug Vusolimogene oderparepvec because the registry names it among its interventions and Angiosarcoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06898970","url":"https://clinicaltrials.gov/study/NCT06898970"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["angiosarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["vusolimogene-oderparepvec","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06898970","phase":"2","setting":"An Open-Label, Multicenter, Phase 2 Study With Safety Lead-In of Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab in Patients With Angiosarcoma","sponsor":"Varun Monga, MBBS","started":"2026-01-09","startedType":"actual","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03945162","kind":"trial","name":"Intravesical Photodynamic Therapy (\"PDT\") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer (\"NMIBC\") Patients","aka":[],"tldr":"A phase 2 trial of Ruvidar® (TLD-1433) bladder infusion and PDT in bladder & urothelial cancer, run by Theralase® Technologies Inc., now recruiting.","summary":"Intravesical Photodynamic Therapy (\"PDT\") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer (\"NMIBC\") Patients is a phase 2 interventional study registered as NCT03945162 by Theralase® Technologies Inc., with 90 participants planned, started 2019-08-30 and due to reach its primary completion in 2026-12. Interventions recorded: Ruvidar® (TLD-1433) bladder infusion and PDT.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03945162","url":"https://clinicaltrials.gov/study/NCT03945162"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03945162","phase":"2","setting":"A Phase II Clinical Study of Intravesical Ruvidar® in Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (\"NMIBC\") Carcinoma In-Situ (\"CIS\") or Patients Who Are Intolerant to BCG Therapy (\"Study II\")","sponsor":"Theralase® Technologies Inc.","started":"2019-08-30","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"intreall-sr-2010","kind":"trial","name":"IntReALL SR 2010","aka":["IntReALL","IntReALL 2010"],"tldr":"IntReALL SR 2010 brought the European relapse groups together to compare their two chemotherapy programmes head to head for children whose leukaemia had returned, and to test adding an antibody against CD22; it has completed and the corpus records the design while the full results are awaited.","summary":"IntReALL SR 2010 was a randomised phase 3 trial of the Resistant Disease Committee of the International BFM Study Group, sponsored by Charite Berlin with co-sponsors across Europe, Australia and New Zealand, for children with standard-risk first relapse of acute lymphoblastic leukaemia (late relapses and isolated extramedullary relapses). The first randomisation compared the German ALL-REZ BFM 2002 induction and consolidation programme with the United Kingdom ALL R3 programme; the second randomised consolidation with or without epratuzumab, an antibody against CD22 that has no record in this corpus. Later amendments introduced blinatumomab in place of chemotherapy blocks, which is how the relapsed childhood leukaemia page cites the trial alongside AALL1331.\n\nThe registry lists 700 participants and a completion date of July 2023. No primary result is posted on the registry or published in a journal indexed by Europe PMC, so the record states the design and not an outcome. The trial's successor, IntReALL 2020, is registered as NCT07476729.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01802814","url":"https://clinicaltrials.gov/study/NCT01802814"}],"tags":["soc-trials"],"related":[],"cancers":["all-paediatric-relapsed","all-leukemia","leukaemia"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["blinatumomab","mitoxantrone"],"companies":[],"institutions":["charite"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01802814","phase":"3","setting":"Children with a standard-risk first relapse of acute lymphoblastic leukaemia across the International BFM Study Group: a first randomisation between the ALL-REZ BFM 2002 and UK ALL R3 induction and consolidation programmes, and a second randomisation adding the anti-CD22 antibody epratuzumab to consolidation","sponsor":"Charite University, Berlin, Germany","started":"2014-05","startedType":"actual","enrolled":700,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07429266","kind":"trial","name":"INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)","aka":["INTREPID"],"tldr":"A phase 3 trial of Sapablursen in myeloproliferative neoplasms, run by Ono Pharmaceutical Co., Ltd., now recruiting.","summary":"INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV) is a phase 3 interventional study registered as NCT07429266 by Ono Pharmaceutical Co., Ltd., with 250 participants planned, started 2026-05-25 and due to reach its primary completion in 2028-09. Interventions recorded: Sapablursen and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07429266","url":"https://clinicaltrials.gov/study/NCT07429266"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","polycythaemia-vera"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07429266","phase":"3","setting":"A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera","sponsor":"Ono Pharmaceutical Co., Ltd.","started":"2026-05-25","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"intuitt-nf2","kind":"trial","name":"INTUITT-NF2","aka":[],"tldr":"INTUITT-NF2 is a rolling trial for people with the inherited condition NF2, who grow many benign tumours of the nerves and brain lining; its first drug, brigatinib, shrank a share of tumours, slowed the growth of all types and improved hearing in a third of affected ears, which is the evidence behind offering it for these tumours.","summary":"INTUITT-NF2 is an investigator-led adaptive platform trial for adults and adolescents with NF2-related schwannomatosis and progressive target tumours, run from Massachusetts General Hospital with the Children's Tumor Foundation and drug supply from Takeda and Incyte. Sub-studies test one drug at a time against a shared design; brigatinib (a kinase inhibitor identified by preclinical screening) was the first, followed by neratinib and retifanlimab with bevacizumab. The primary endpoint of each sub-study is the radiographic response rate.\n\nIn the brigatinib sub-study 40 patients with 10 vestibular schwannomas, 8 non-vestibular schwannomas, 20 meningiomas and 2 ependymomas as target tumours were treated; 10 percent of target tumours and 23 percent of all tumours responded, annualised growth rates fell for every tumour type, hearing improved in 35 percent of eligible ears and there were no grade 4 or 5 treatment-related events. The corpus's vestibular schwannoma page cites INTUITT-NF2 as the evidence for brigatinib.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04374305","url":"https://clinicaltrials.gov/study/NCT04374305"}],"tags":["soc-trials"],"related":[],"cancers":["vestibular-schwannoma","meningioma","brain-tumours"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["brigatinib","neratinib","retifanlimab","bevacizumab"],"companies":["takeda","incyte"],"institutions":["mgh"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-intuitt-nf2-brigatinib-plotkin-nejm-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04374305","phase":"2","setting":"NF2-related schwannomatosis with progressive vestibular or non-vestibular schwannomas, meningiomas or ependymomas: an adaptive platform trial testing targeted drugs in sub-studies (brigatinib, closed; neratinib; retifanlimab with bevacizumab), with radiographic response as the primary endpoint","sponsor":"Scott R. Plotkin, MD, PhD (Massachusetts General Hospital)","result":"Brigatinib produced radiographic responses in 10 percent of target tumours and 23 percent of all tumours, slowed growth of every tumour type and improved hearing in 35 percent of eligible ears in 40 heavily pretreated patients.","started":"2020-06-20","startedType":"actual","yearReported":2024,"enrolled":109,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic response rate, target tumours (brigatinib sub-study)","primary":true,"unit":"%","arms":[{"name":"Brigatinib","n":40,"value":10,"note":"95% CI 3 to 24; median follow-up 10.4 months"}],"source":"https://doi.org/10.1056/NEJMoa2400985"},{"endpoint":"Radiographic response rate, all tumours (brigatinib sub-study)","unit":"%","arms":[{"name":"Brigatinib","n":40,"value":23,"note":"95% CI 16 to 30"}],"source":"https://doi.org/10.1056/NEJMoa2400985"},{"endpoint":"Hearing improvement in eligible ears (brigatinib sub-study)","unit":"%","arms":[{"name":"Brigatinib","value":35,"note":"95% CI 20 to 53"}],"source":"https://doi.org/10.1056/NEJMoa2400985"}]},{"id":"nct06197425","kind":"trial","name":"Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer","aka":["CIRCULATE PAC"],"tldr":"A phase 3 trial in colorectal cancer, run by Centre Hospitalier Universitaire Dijon, now recruiting.","summary":"Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer is a phase 3, randomised interventional study registered as NCT06197425 by Centre Hospitalier Universitaire Dijon, with a registry enrolment figure of 1660 participants, started 2026-05-07 and due to reach its primary completion in 2032-05. Interventions recorded: \"FOLFIRI\" cures; Trifluridine cures; BIOLOGICAL ASSESSMENT; Questionnaires; Thoracic-abdomino-pelvic scan or MRI. Conditions listed: Colon or Upper Rectum Adenocarcinoma. Primary outcome: The time to recurrence (TTR). Colorectal eligibility wording from the registry: \"* Fully resected stage III or high-risk stage II colon or upper rectum adenocarcinoma previously treated by standard adjuvant chemotherapy or peri-operative chemotherapy (FOLFOX or CAPOX) for either 3 or 6 months based on local multidisciplinary meeting, and on TNCD recommendations\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06197425","url":"https://clinicaltrials.gov/study/NCT06197425"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06197425","phase":"3","setting":"Phase III Multicentric, Open-label, Randomized Study to Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer (PRODIGE 88)","sponsor":"Centre Hospitalier Universitaire Dijon","started":"2026-05-07","startedType":"actual","enrolled":1660,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07745296","kind":"trial","name":"Investigating Precision Medicine in the Adjuvant Setting in Biliary Tract Cancer","aka":["SAFIR-IMPACT"],"tldr":"A phase 3 trial of zanidatamab, capecitabine, futibatinib and ivosidenib in gallbladder cancer and other biliary tract cancers, run by UNICANCER, not yet recruiting.","summary":"Investigating Precision Medicine in the Adjuvant Setting in Biliary Tract Cancer is a phase 3, randomised interventional study registered as NCT07745296 by UNICANCER, with a registry enrolment figure of 990 participants, started 2027-01-02 and due to reach its primary completion in 2033-07-02. Interventions recorded: Futibatinib, Ivosidenib + Capecitabine, Zanidatamab + Capecitabine, Capecitabine (Xeloda). Conditions listed: Biliary Tract Cancer (BTC). Gallbladder cancer is named in the registry entry: \"2. Histologically-proven intrahepatic cholangiocarcinoma, perihilar or distal extrahepatic cholangiocarcinoma or gallbladder carcinoma (ampullary carcinoma is excluded)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07745296","url":"https://clinicaltrials.gov/study/NCT07745296"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":["bispecific-antibody","cytotoxic-chemotherapy","kinase-inhibitors","idh-inhibitors"],"targets":[],"drugs":["zanidatamab","capecitabine","futibatinib","ivosidenib"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07745296","phase":"3","setting":"Investigating Precision Medicine in the Adjuvant Setting: a Phase 3 Clinical Trial in Biliary Tract Cancer","sponsor":"UNICANCER","started":"2027-01-02","startedType":"estimated","enrolled":990,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07718243","kind":"trial","name":"Investigating the Combination of Bexmarilimab and Nivolumab in Solid Tumours, Melanoma and NSCLC","aka":["BLAZE"],"tldr":"A phase 1/2 trial in lung cancer, run by Institute of Cancer Research, United Kingdom, now recruiting.","summary":"Investigating the Combination of Bexmarilimab and Nivolumab in Solid Tumours, Melanoma and NSCLC is a phase 1/2, interventional study registered as NCT07718243 by Institute of Cancer Research, United Kingdom, with a registry enrolment figure of 62 participants, started 2026-08-28 and due to reach its primary completion in 2030-01-31. Interventions recorded: Bexmarilimab 1mg/kg and nivolumab 1mg/kg; Bexmarilimab 3mg/kg and nivolumab 1mg/kg; Recommended Phase II Dose. Conditions listed: Melanoma (Skin Cancer); Non Small Cell Lung Cancer; Solid Tumor in Advanced Stage. Primary outcome: To establish a recommended Phase II dose (RP2D) of bexmarilimab in combination with nivolumab; Determining causality of each adverse event to bexmarilimab and nivolumab and grading severity according to the NCI CTCAE Version 5.0; Evaluation of disease response by RECIST criteria version 1.1, immune-. Lung eligibility wording from the registry: \"Part B1: Histologically proven NSCLC\". Sites: United Kingdom. United Kingdom sites listed: 2. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07718243","url":"https://clinicaltrials.gov/study/NCT07718243"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["faron-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): The Christie NHS Foundation Trust (Manchester); The Royal Marsden NHS Foundation Trust - Drug Development Unit (Sutton)."],"nct":"NCT07718243","phase":"1/2","setting":"A Phase I/II Trial of Bexmarilimab and Nivolumab in Patients With Solid Tumours, Non-Small Cell Lung Cancer and Melanoma","sponsor":"Institute of Cancer Research, United Kingdom","started":"2026-08-28","startedType":"actual","enrolled":62,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03808337","kind":"trial","name":"Investigating the Effectiveness of Stereotactic Body Radiotherapy (SBRT) in Addition to Standard of Care Treatment for Cancer That Has Spread Beyond the Origina","aka":["PROMISE-005"],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"Investigating the Effectiveness of Stereotactic Body Radiotherapy (SBRT) in Addition to Standard of Care Treatment for Cancer That Has Spread Beyond the Original Site of Disease is a phase 2, randomised interventional study registered as NCT03808337 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 145 participants, started 2019-01-16 and due to reach its primary completion in 2027-01. Interventions recorded: Stereotactic Body Radiotherapy/SBRT; Systemic Therapy/Standard of Care. Conditions listed: Triple Negative Breast Cancer; Non Small Cell Lung Cancer; Metastatic Breast Cancer; Metastatic Non-Small Cell Lung Carcinoma. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03808337","url":"https://clinicaltrials.gov/study/NCT03808337"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03808337","phase":"2","setting":"PROMISE-005: A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung Cancer","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2019-01-16","startedType":"actual","enrolled":145,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04273061","kind":"trial","name":"Investigating the Effects of Atezolizumab in People Whose Tumour DNA or RNA Indicates Possible Sensitivity","aka":["CAPTIV-8"],"tldr":"A phase 2 trial of atezolizumab in lung cancer, run by British Columbia Cancer Agency, now recruiting.","summary":"Investigating the Effects of Atezolizumab in People Whose Tumour DNA or RNA Indicates Possible Sensitivity is a phase 2, interventional study registered as NCT04273061 by British Columbia Cancer Agency, with a registry enrolment figure of 50 participants, started 2020-06-17 and due to reach its primary completion in 2027-10. Interventions recorded: Atezolizumab. Conditions listed: Breast Cancer; Lung Cancer; Gastrointestinal Cancer; Genitourinary Cancer; Gynecologic Cancer; Sarcoma; Unknown Primary Tumors; Head and Neck Cancer; Skin Cancer. Primary outcome: Overall response rate (ORR) for the study cohort, as defined by RECIST 1.1. Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04273061","url":"https://clinicaltrials.gov/study/NCT04273061"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04273061","phase":"2","setting":"Canadian Atezolizumab Precision Targeting for Immunotherapy Intervention","sponsor":"British Columbia Cancer Agency","started":"2020-06-17","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05016349","kind":"trial","name":"Investigating the Potential Role of a Novel Quadrate Combination Therapy Mifepristone(Antiprogestrone), Tamoxifen, Retinoic Acid and Cannabidiol ( Selective Cyp 26 Inhibitor) for Treating Early Breast Cancer","aka":[],"tldr":"A phase 3 trial of Tretinoin, Mifepristone, Alitretinoin and Tamoxifen in Breast cancer, run by Mahmoud Ramadan mohamed Elkazzaz, with a status the registry has not verified recently.","summary":"Investigating the Potential Role of a Novel Quadrate Combination Therapy Mifepristone(Antiprogestrone), Tamoxifen, Retinoic Acid and Cannabidiol ( Selective Cyp 26 Inhibitor) for Treating Early Breast Cancer is a phase 3 interventional study registered as NCT05016349 by Mahmoud Ramadan mohamed Elkazzaz, with 160 participants planned, started 2021-08 and due to reach its primary completion in 2021-10. Interventions recorded: All trans-retinoic acid, 13-Cis Retinoic Acid plus Tocopherol, Mifepristone, Cannabidiol, 9 cis retinoic acid, Tamoxifen, Standard therapy. Conditions recorded: Breast Cancer Female.\n\nLinked to the drug Alitretinoin because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05016349","url":"https://clinicaltrials.gov/study/NCT05016349"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tretinoin-atra","mifepristone","alitretinoin","tamoxifen"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05016349","phase":"3","setting":"Why Antiprogestrone (Mifepristone) and Cyp 26 Inhibitor Must be Combined With Tamoxifen or ( Tamoxifen and Retinoic Acid) for Treating Early Breast Cancer","sponsor":"Mahmoud Ramadan mohamed Elkazzaz","started":"2021-08","startedType":"estimated","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07615101","kind":"trial","name":"Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.","aka":[],"tldr":"A phase 3 trial of 68-Ga-NYM032 in prostate cancer, run by Norroy Bioscience Co., LTD, now recruiting.","summary":"Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer. is a phase 3 interventional study registered as NCT07615101 by Norroy Bioscience Co., LTD, with 365 participants planned, started 2026-08-06 and due to reach its primary completion in 2027-06-30. Interventions recorded: 68-Ga-NYM032.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07615101","url":"https://clinicaltrials.gov/study/NCT07615101"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["pet","pet-ct"],"targets":[],"drugs":[],"companies":["norroy-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07615101","phase":"3","setting":"Open-label, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.","sponsor":"Norroy Bioscience Co., LTD","started":"2026-08-06","startedType":"actual","enrolled":365,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03096093","kind":"trial","name":"Investigation of a Therapeutic Vaccine (ACIT-1) in Cancer","aka":["ACIT-1"],"tldr":"A phase 1/2 trial of ACIT-1 in advanced solid tumours, run by Cancer Vaccines Limited, active and no longer recruiting.","summary":"Investigation of a Therapeutic Vaccine (ACIT-1) in Cancer is a phase 1/2 interventional study registered as NCT03096093 by Cancer Vaccines Limited, with 34 participants enrolled, started 2017-04-25 and due to reach its primary completion in 2026-12. Interventions recorded: ACIT-1.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03096093","url":"https://clinicaltrials.gov/study/NCT03096093"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03096093","phase":"1/2","setting":"A Phase I Clinical Study to Determine the Optimal Dose for the Safe Immune Restoration and Immune Response of Allogeneic Cell Immunotherapy (ACIT-1) in Adult Cancer Patients","sponsor":"Cancer Vaccines Limited","started":"2017-04-25","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04851717","kind":"trial","name":"Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures","aka":[],"tldr":"A phase 2/3 trial of Remimazolam in childhood cancers, run by Acacia Pharma Ltd, active and no longer recruiting.","summary":"Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures is a phase 2/3 interventional study registered as NCT04851717 by Acacia Pharma Ltd, with 100 participants enrolled, started 2021-11-15 and due to reach its primary completion in 2027-10. Interventions recorded: Remimazolam.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04851717","url":"https://clinicaltrials.gov/study/NCT04851717"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["childhood-cancers"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["acacia-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04851717","phase":"2/3","setting":"A Phase 2/3, Prospective, Open-label Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of Remimazolam for Intravenous Sedation in Paediatric Patients Undergoing Diagnostic and/or Therapeutic Procedures","sponsor":"Acacia Pharma Ltd","started":"2021-11-15","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07430696","kind":"trial","name":"INVESTIGATION OF THE ANTI-NEOPLASTIC EFFECT OF TRISHUL (AYURVEDIC AGENT) ON TUMOUR REGRESSION OF RECTAL CANCER- A PILOT STUDY","aka":["AYURVEDIC AGENT"],"tldr":"A phase 2 trial in colorectal cancer, run by University of Kelaniya, not yet recruiting.","summary":"INVESTIGATION OF THE ANTI-NEOPLASTIC EFFECT OF TRISHUL (AYURVEDIC AGENT) ON TUMOUR REGRESSION OF RECTAL CANCER- A PILOT STUDY is a phase 2, randomised interventional study registered as NCT07430696 by University of Kelaniya, with a registry enrolment figure of 40 participants, started 2026-05-01 and due to reach its primary completion in 2027-05-01. Interventions recorded: Trishul 750 mg bd orally. Conditions listed: Efficacy of Trishul. Primary outcome: Overall survival; Overall survival. Colorectal eligibility wording from the registry: \"* Histologically confirmed diagnosis of adenocarcinoma of the rectum stratified for grade of tumour of biopsy samples (Grade 1 and 11 vs 111)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07430696","url":"https://clinicaltrials.gov/study/NCT07430696"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07430696","phase":"2","setting":"INVESTIGATION OF THE ANTI-NEOPLASTIC EFFECT OF TRISHUL (AYURVEDIC AGENT) ON TUMOUR REGRESSION OF RECTAL CANCER- A PILOT STUDY","sponsor":"University of Kelaniya","started":"2026-05-01","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03878849","kind":"trial","name":"Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer","aka":[],"tldr":"A phase 2 trial of 2X-121 in ovarian cancer, run by Allarity Therapeutics, now recruiting.","summary":"Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer is a phase 2 interventional study registered as NCT03878849 by Allarity Therapeutics, with 40 participants planned, started 2019-04-15 and due to reach its primary completion in 2027-03. Interventions recorded: 2X-121.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03878849","url":"https://clinicaltrials.gov/study/NCT03878849"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03878849","phase":"2","setting":"Phase 2, Randomized, Prospective, Open-Label, Parallel-Arm, Dose Optimization Study to Investigate the Safety, Tolerability, PK/PD, and Anti- Tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer.","sponsor":"Allarity Therapeutics","started":"2019-04-15","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00884273","kind":"trial","name":"Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients","aka":[],"tldr":"A phase 3 trial of Degarelix, Goserelin / leuprolide and Bicalutamide in Prostate cancer, run by Ferring Pharmaceuticals, completed.","summary":"Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients is a phase 3 interventional study registered as NCT00884273 by Ferring Pharmaceuticals, with 182 participants recorded, started 2009-08 and reaching its primary completion in 2011-03. Interventions recorded: Degarelix, Goserelin, Bicalutamide. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Degarelix because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00884273","url":"https://clinicaltrials.gov/study/NCT00884273"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["degarelix","goserelin","bicalutamide"],"companies":["ferring"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00884273","phase":"3","setting":"A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Volume Reduction of the Prostate in Patients With Prostate Cancer Being Candidates for Medical Castration","sponsor":"Ferring Pharmaceuticals","started":"2009-08","yearReported":2012,"enrolled":182,"enrolledBasis":"registry","outcomes":[{"endpoint":"Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)","primary":true,"unit":"milliliter","arms":[{"name":"Degarelix 240 mg/80 mg","n":82,"value":-37.2,"note":"SD 16.8; Figures from the ClinicalTrials.gov results section (first posted 2012-04-11), not from a publication"},{"name":"Goserelin (3.6 mg) + Bicalutamide (50 mg)","n":97,"value":-39,"note":"SD 17.7"}],"p":"0.36","source":"https://clinicaltrials.gov/study/NCT00884273?tab=results"}]},{"id":"nct06787612","kind":"trial","name":"Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer","aka":[],"tldr":"A phase 2 trial of Bevacizumab, Cemiplimab, Fianlimab in ovarian cancer, run by Regeneron Pharmaceuticals, now recruiting.","summary":"Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer is a phase 2 interventional study registered as NCT06787612 by Regeneron Pharmaceuticals, with 297 participants planned, started 2025-05-28 and due to reach its primary completion in 2028-06-30. Interventions recorded: Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD. Conditions listed: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06787612","url":"https://clinicaltrials.gov/study/NCT06787612"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab","cemiplimab","fianlimab","pegylated-liposomal-doxorubicin"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06787612","phase":"2","setting":"Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer","sponsor":"Regeneron Pharmaceuticals","started":"2025-05-28","startedType":"actual","enrolled":297,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05518903","kind":"trial","name":"Investigational Scan (68Ga-FAPI-46 PET/CT) for Imaging of Cancer-Associated Fibroblasts for Localized Pancreatic Ductal Adenocarcinoma","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Mayo Clinic, now recruiting.","summary":"Investigational Scan (68Ga-FAPI-46 PET/CT) for Imaging of Cancer-Associated Fibroblasts for Localized Pancreatic Ductal Adenocarcinoma is a phase 2, interventional study registered as NCT05518903 by Mayo Clinic, with a registry enrolment figure of 130 participants, started 2022-11-15 and due to reach its primary completion in 2027-06-30. Interventions recorded: Computed Tomography; Gallium Ga 68 FAPi-46; Positron Emission Tomography. Conditions listed: Localized Pancreatic Adenocarcinoma; Resectable Pancreatic Ductal Adenocarcinoma; Stage 0 Pancreatic Cancer AJCC v8; Stage I Pancreatic Cancer AJCC v8; Stage IIA Pancreatic Cancer AJCC v8. Primary outcome: Diagnostic performance of fibroblast-activation-protein-inhibitors (FAPI) positron emission tomography (PET) for detection and quantification of cancer-associated fibroblasts (CAFs) in pancreatic ductal adenocarcinoma (PDA); Relationship between 68Ga-FAPI-46 PET metrics in PDA; Relationship between . Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05518903","url":"https://clinicaltrials.gov/study/NCT05518903"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05518903","phase":"2","setting":"Quantitative In Vivo 68Ga-Fibroblast-Activation-Protein-Inhibitors (FAPI)-46 PET Imaging of Cancer-Associated Fibroblasts (CAFs) in Pancreatic Ductal Adenocarcinoma (PDA)","sponsor":"Mayo Clinic","started":"2022-11-15","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"invictus","kind":"trial","name":"INVICTUS","aka":[],"tldr":"Ripretinib kept fourth-line GIST under control six times longer than placebo and improved survival.","summary":"INVICTUS, trial NCT03353753 sponsored by Deciphera and published in Lancet Oncology in 2020, showed that the switch-control kinase inhibitor ripretinib keeps fourth-line gastrointestinal stromal tumour under control roughly six times longer than placebo and improves survival. It randomised 129 patients after at least three kinase inhibitors and met its primary progression-free survival endpoint with a very large effect and a survival benefit, leading to approval in May 2020. OnCo links it to sarcomas and GIST, KIT as a target and ripretinib. Whether ripretinib can move earlier in the sequence, which INTRIGUE and the mutation-selected INSIGHT trial address, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03353753","url":"https://clinicaltrials.gov/study/NCT03353753"}],"tags":[],"related":[],"cancers":["sarcoma","gist-imatinib-resistant"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["kit"],"drugs":["ripretinib"],"companies":["deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03353753","phase":"3","setting":"Advanced GIST after ≥3 kinase inhibitors: ripretinib vs placebo","sponsor":"Deciphera","result":"PFS HR 0.15; OS HR 0.36.","started":"2018-02-27","startedType":"actual","yearReported":2020,"enrolled":129,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Ripretinib","n":85,"value":6.3},{"name":"Placebo","n":44,"value":1}],"hr":0.15,"ci":[0.09,0.25],"p":"<0.0001","source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30168-6/fulltext"},{"endpoint":"Overall survival (median)","unit":"months","arms":[{"name":"Ripretinib","value":15.1},{"name":"Placebo","value":6.6}],"hr":0.36,"source":"https://doi.org/10.1016/S1470-2045(20)30168-6"}]},{"id":"nct07161115","kind":"trial","name":"Involve-site Radiotherapy Combined With Chemotherapy and Immunotherapy as Neoadjuvant Treatment for Locally Advanced Rectal Cancer","aka":["REFIRT"],"tldr":"A phase 2 trial in colorectal cancer, run by Longhao Li, not yet recruiting.","summary":"Involve-site Radiotherapy Combined With Chemotherapy and Immunotherapy as Neoadjuvant Treatment for Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT07161115 by Longhao Li, with a registry enrolment figure of 60 participants, started 2025-09-19 and due to reach its primary completion in 2028-08-31. Interventions recorded: Reduced-field short-course radiotherapy; Immunotherapy combined with chemotherapy; Standard short-course radiotherapy; Standard long-course radiotherapy; Chemotherapy. Conditions listed: Rectal Adenocarcinoma. Primary outcome: Two-year local control rate after rectal cancer surgery. Colorectal eligibility wording from the registry: \"* Histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07161115","url":"https://clinicaltrials.gov/study/NCT07161115"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07161115","phase":"2","setting":"A Phase II Study Evaluating the Efficacy and Safety of Neoadjuvant Therapy With MRI-Guided Involve-site Short-Course Radiotherapy Combined With Immunotherapy and Chemotherapy for Locally Advanced Rectal Cancer","sponsor":"Longhao Li","started":"2025-09-19","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05155254","kind":"trial","name":"IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)","aka":[],"tldr":"A phase 3 trial testing IO102-IO103 in melanoma, active and no longer recruiting.","summary":"IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18) is a phase 3 interventional study registered as NCT05155254, led by IO Biotech with Syneos Health and Merck Sharp & Dohme, and active but no longer recruiting on the registry. Official title: An Open-label, Randomised, Phase 3 Clinical Trial of IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Patients With Previously Untreated, Unresectable, or Metastatic (Advanced) Melanoma (IO102-IO103-013 / MK3475-D18). Planned enrolment is 407 participants (actual). The study started in 2022-05-17 and primary completion is expected in 2025-05-30. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05155254","url":"https://clinicaltrials.gov/study/NCT05155254"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["io102-io103"],"companies":["io-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05155254","phase":"3","setting":"An Open-label, Randomized, Phase 3 Clinical Trial of IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Patients With Previously Untreated, Unresectable, or Metastatic (Advanced) Melanoma (IO102-IO103-013 / MK3475-D18)","sponsor":"IO Biotech","started":"2022-05-17","startedType":"actual","enrolled":407,"enrolledBasis":"registry","outcomes":[]},{"id":"ion-trial","kind":"trial","name":"IoN","aka":[],"tldr":"The UK trial confirming that low-risk thyroid cancer patients can safely avoid radioactive iodine, published in 2025.","summary":"IoN, trial NCT01398085 sponsored by Cancer Research UK and UCL and published in the Lancet in 2025, is the UK trial confirming that low-risk differentiated thyroid cancer patients can safely avoid radioactive iodine after thyroidectomy. It randomised 504 patients with pT1 to T2, node-negative tumours without adverse features to no radioiodine or radioiodine ablation and met its non-inferiority endpoint on recurrence-free status at five years, extending the ESTIMABL2 finding to pT2 tumours. OnCo links it to thyroid cancer, radioiodine therapy, radioactive iodine, the low-risk thyroid cancer term and Cancer Research UK, and it replicates ESTIMABL2. Guideline bodies now recommend against routine ablation in this group, and whether patients and clinicians accept doing less is the practical question that remains.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01398085","url":"https://clinicaltrials.gov/study/NCT01398085"},{"label":"Lancet 2025","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00629-4/fulltext"}],"tags":[],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["radioiodine-therapy"],"targets":[],"drugs":[],"companies":[],"institutions":["cruk"],"pathways":[],"terms":["low-risk-dtc"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01398085","phase":"2/3","setting":"Low-risk differentiated thyroid cancer (pT1-T2, N0/Nx, no adverse features) after thyroidectomy: no radioiodine vs radioiodine ablation","sponsor":"Cancer Research UK / UCL","result":"5-year recurrence-free ~98% (no RAI) vs ~96% (RAI).","started":"2012-06-26","startedType":"actual","yearReported":2025,"enrolled":504,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free at 5 years","primary":true,"unit":"%","arms":[{"name":"No radioiodine","value":98},{"name":"Radioiodine","value":96}],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00629-4/fulltext"}],"replication":"Replicates ESTIMABL2."},{"id":"nct07263360","kind":"trial","name":"Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer","aka":[],"tldr":"A phase 2 trial of gemcitabine, oxaliplatin and lenvatinib in gallbladder cancer and other biliary tract cancers, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer is a phase 2 interventional study registered as NCT07263360 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 29 participants, started 2026-02-01 and due to reach its primary completion in 2028-03-31. Interventions recorded: Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib. Conditions listed: BTC. Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07263360","url":"https://clinicaltrials.gov/study/NCT07263360"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","kinase-inhibitors"],"targets":[],"drugs":["gemcitabine","oxaliplatin","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07263360","phase":"2","setting":"A Single-arm, Single-center Clinical Study of Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2026-02-01","startedType":"estimated","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07447570","kind":"trial","name":"Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for HAHNSCC","aka":[],"tldr":"A phase 2 trial of Iparomlimab and tuvonralimab in Head and neck squamous cell carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for HAHNSCC is a phase 2 interventional study registered as NCT07447570 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with 27 participants planned, started 2025-10-15 and due to reach its primary completion in 2027-12-31. Interventions recorded: Iparomlimab and Tuvonralimab injection, Hypofractionated Radiotherapy, Chemotherapy. Conditions recorded: Head and Neck Cancer, Radiotherapy, Anti-PD-1/CTLA-4 Antibody.\n\nLinked to the drug Iparomlimab and tuvonralimab because the registry names it among its interventions and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07447570","url":"https://clinicaltrials.gov/study/NCT07447570"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":["iparomlimab-tuvonralimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07447570","phase":"2","setting":"Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: a Multicenter, Single-arm, Phase II Clinical Study","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2025-10-15","startedType":"actual","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07007728","kind":"trial","name":"Iparomlimab/Tuvonralimab Combined With Bevacizumab and CAPEOX as Conversion Therapy for Colorectal Cancer Liver Metastasis","aka":[],"tldr":"A phase 2 trial of bevacizumab (glioblastoma use) and cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Peking University Cancer Hospital & Institute, not yet recruiting.","summary":"Iparomlimab/Tuvonralimab Combined With Bevacizumab and CAPEOX as Conversion Therapy for Colorectal Cancer Liver Metastasis is a phase 2, interventional study registered as NCT07007728 by Peking University Cancer Hospital & Institute, with a registry enrolment figure of 54 participants, started 2025-06-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: Iparomlimab/Tuvonralimab; Bevacizumab + CAPEOX; Surgical resection ± ablation or stereotactic radiotherapy (if applicable). Conditions listed: Colorectal Neoplasms; Secondary Malignant Neoplasm of Liver. Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"Pathologically confirmed colorectal adenocarcinoma with liver metastases confirmed by pathology or imaging;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07007728","url":"https://clinicaltrials.gov/study/NCT07007728"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","sbrt","thermal-ablation"],"targets":[],"drugs":["bevacizumab-glioma","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07007728","phase":"2","setting":"Efficacy and Safety of Iparomlimab/Tuvonralimab Combined With Bevacizumab and CAPEOX as Conversion Therapy in Patients With Right-Sided or RAS-mutant, Microsatellite Stable, Initially Unresectable Colorectal Cancer Liver Metastasis: A Prospective, Open-Label, Single-Arm, Single-Center, Phase II Clinical Trial","sponsor":"Peking University Cancer Hospital & Institute","started":"2025-06-01","startedType":"estimated","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07026422","kind":"trial","name":"Iparomlimab/Tuvonralimab Integrating With Total Neoadjuvant Therapy for pMMR/MSS Locally Advanced Rectal Cancer (IT-TNT)","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Shandong Cancer Hospital and Institute, now recruiting.","summary":"Iparomlimab/Tuvonralimab Integrating With Total Neoadjuvant Therapy for pMMR/MSS Locally Advanced Rectal Cancer (IT-TNT) is a phase 2, interventional study registered as NCT07026422 by Shandong Cancer Hospital and Institute, with a registry enrolment figure of 54 participants, started 2025-04-30 and due to reach its primary completion in 2026-11-30. Interventions recorded: Total neoadjuvant therapy integrating iparomlimab/tuvonralimab with chemoradiotherapy. Conditions listed: Rectal Malignant Neoplasms. Primary outcome: Overall complete response (CR) rate. Colorectal eligibility wording from the registry: \"Histologically confirmed pMMR/MSS rectal adenocarcinoma, defined by MRI as clinical stage II (T3-4, N-) or stage III (any T, N+)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07026422","url":"https://clinicaltrials.gov/study/NCT07026422"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07026422","phase":"2","setting":"Iparomlimab/Tuvonralimab Integrating With Total Neoadjuvant Therapy for pMMR/MSS Locally Advanced Rectal Cancer (IT-TNT): A Single-arm, Exploratory, Phase II Trial","sponsor":"Shandong Cancer Hospital and Institute","started":"2025-04-30","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"ipatunity130","kind":"trial","name":"IPATunity130","aka":[],"tldr":"IPATunity130 tried to confirm a promising early signal for the AKT-blocking tablet ipatasertib with paclitaxel in triple-negative breast cancers carrying PI3K-pathway mutations. It failed: progression and survival were the same with or without the drug, and the ipatasertib programme in breast cancer ended.","summary":"IPATunity130 (NCT03337724) was a double-blind placebo-controlled phase 3 trial whose cohort A randomised 255 taxane-eligible patients with PIK3CA, AKT1 or PTEN-altered measurable advanced triple-negative breast cancer and no prior chemotherapy for advanced disease 2 to 1 (168 to 87) between February 2018 and April 2020 to ipatasertib 400 mg on days 1 to 21 or placebo, both with paclitaxel 80 mg/m2 on days 1, 8 and 15 every 28 days. The primary endpoint, investigator-assessed progression-free survival, showed no difference (hazard ratio 1.02, 95 percent confidence interval 0.71 to 1.45; medians 7.4 versus 6.1 months), and final overall survival was 24.4 versus 24.9 months (hazard ratio 1.08, 0.73 to 1.58). Ipatasertib added grade 3 or worse diarrhoea (9 versus 2 percent) and dose reductions (39 versus 14 percent) with similar overall grade 3 or worse adverse events (51 versus 46 percent); exploratory PAM50 and Burstein subtype analyses were inconsistent. The randomised phase 2 LOTUS trial had suggested a progression-free survival gain in the biomarker-altered subgroup that this trial did not validate; with CAPItello-290 (capivasertib) it shows that PI3K, AKT or PTEN alteration does not select triple-negative tumours for AKT inhibition. UK sites (registry, 7): Velindre Cardiff, University Hospital Coventry, Beatson Glasgow, Royal Marsden London and Sutton, Derriford Plymouth, Royal Stoke.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03337724","url":"https://clinicaltrials.gov/study/NCT03337724"},{"label":"Dent et al., Clinical Cancer Research 2024: ipatasertib plus paclitaxel in PIK3CA/AKT1/PTEN-altered TNBC, IPATunity130 cohort A","url":"https://doi.org/10.1158/1078-0432.CCR-24-0465"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["pi3k-akt-mtor-inhibitors","cytotoxic-chemotherapy"],"targets":["akt","pik3ca","pten"],"drugs":["ipatasertib","paclitaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":["pi3k-akt-mtor"],"terms":[],"trials":["nct03997123","barbican"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 7): Velindre Cancer Centre Cardiff, University Hospital Coventry, Beatson West of Scotland Cancer Centre Glasgow, Royal Marsden Hospital London and Sutton, Derriford Hospital Plymouth, Royal Stoke University Hospital."],"nct":"NCT03337724","phase":"3","setting":"PIK3CA, AKT1 or PTEN-altered locally advanced unresectable or metastatic triple-negative breast cancer, no prior chemotherapy for advanced disease: first-line paclitaxel with ipatasertib or placebo (cohort A), 30 countries including the United Kingdom","sponsor":"Hoffmann-La Roche","result":"PFS 7.4 vs 6.1 months (HR 1.02, 0.71 to 1.45); OS 24.4 vs 24.9 months (HR 1.08). Negative.","started":"2018-01-06","startedType":"actual","yearReported":2024,"enrolled":255,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 579 participants across cohorts A (PIK3CA/AKT1/PTEN-altered triple-negative), B (hormone-receptor-positive) and C; the triple-negative cohort A randomised 255 patients.","outcomes":[{"endpoint":"Progression-free survival (investigator), cohort A","primary":true,"unit":"months","arms":[{"name":"Ipatasertib + paclitaxel","n":168,"value":7.4},{"name":"Placebo + paclitaxel","n":87,"value":6.1}],"hr":1.02,"ci":[0.71,1.45],"source":"https://doi.org/10.1158/1078-0432.CCR-24-0465"},{"endpoint":"Overall survival, cohort A","unit":"months","arms":[{"name":"Ipatasertib + paclitaxel","value":24.4},{"name":"Placebo + paclitaxel","value":24.9}],"hr":1.08,"ci":[0.73,1.58],"source":"https://doi.org/10.1158/1078-0432.CCR-24-0465"}],"replication":"Failed to confirm the phase 2 LOTUS signal; CAPItello-290 with capivasertib reached the same negative conclusion for overall survival."},{"id":"nct07508761","kind":"trial","name":"IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Toripalimab in advanced solid tumours, run by Nanjing Immunophage Biotech Co., Ltd, now recruiting.","summary":"IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07508761 by Nanjing Immunophage Biotech Co., Ltd, with 52 participants planned, started 2026-06-16 and due to reach its primary completion in 2028-12-30. Interventions recorded: IPG7236 and Toripalimab Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07508761","url":"https://clinicaltrials.gov/study/NCT07508761"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":["nanjing-immunophage-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07508761","phase":"1/2","setting":"A Phase I/II Multicenter, Non-randomized, Open-label, Dose Escalation and Expansion Study of IPG7236 Combined With Toripalimab Treatment of Advanced Solid Tumors in Adult Patients to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity","sponsor":"Nanjing Immunophage Biotech Co., Ltd","started":"2026-06-16","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05742607","kind":"trial","name":"IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)","aka":["MATISSE"],"tldr":"A phase 2 trial of Durvalumab, Carboplatin, Paclitaxel / nab-paclitaxel in non-small-cell lung cancer and small-cell lung cancer, run by Innate Pharma, now recruiting.","summary":"IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE) is a phase 2 interventional study registered as NCT05742607 by Innate Pharma, with 70 participants planned, started 2023-06-23 and due to reach its primary completion in 2027-06. Interventions recorded: IPH5201 + durvalumab + standard chemotherapy. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05742607","url":"https://clinicaltrials.gov/study/NCT05742607"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","carboplatin","paclitaxel","pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05742607","phase":"2","setting":"Official Title: A Phase II Multicenter, Open Label, Non-randomized Study of Neoadjuvant and Adjuvant Treatment With IPH5201 and Durvalumab in Patients With Resectable, Early-Stage (II to III) Non-Small Cell Lung CancEr (MATISSE)","sponsor":"Innate Pharma","started":"2023-06-23","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07306273","kind":"trial","name":"IRE Combined With the Dual-Function Antibody PD-1/CTLA-4 for the Treatment of LAPC Following Failure of First-Line AG Therapy","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Ruijin Hospital, now recruiting.","summary":"IRE Combined With the Dual-Function Antibody PD-1/CTLA-4 for the Treatment of LAPC Following Failure of First-Line AG Therapy is a phase 2, interventional study registered as NCT07306273 by Ruijin Hospital, with a registry enrolment figure of 20 participants, started 2025-12-15 and due to reach its primary completion in 2027-08-01. Interventions recorded: Irreversible electroporation; Dual-Function Antibody PD-1/CTLA-4. Conditions listed: Pancreatic Adenocarcinoma Locally Advanced. Primary outcome: Overall Survival. Pancreatic eligibility wording from the registry: \"* Pathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records indicating locally advanced pancreatic cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07306273","url":"https://clinicaltrials.gov/study/NCT07306273"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["irreversible-electroporation"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07306273","phase":"2","setting":"A Single-Arm, Open-Label Clinical Study of Irreversible Electroporation(IRE) Combined With the Dual-Function Antibody PD-1/CTLA-4 (Apalulizumab) for the Treatment of Locally Advanced Pancreatic Cancer Following Failure of First-Line AG Therapy","sponsor":"Ruijin Hospital","started":"2025-12-15","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06603376","kind":"trial","name":"Irinotecan Hydrochloride Liposome Injection (II) Combined with Fluorouracil, Folinic Acid, Vermofenib and Cetuximab in First-line Treatment of BRAFV600E Mutated","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Shanghai Changzheng Hospital, now recruiting.","summary":"Irinotecan Hydrochloride Liposome Injection (II) Combined with Fluorouracil, Folinic Acid, Vermofenib and Cetuximab in First-line Treatment of BRAFV600E Mutated Advanced Colorectal Cancer is a phase 2, randomised interventional study registered as NCT06603376 by Shanghai Changzheng Hospital, with a registry enrolment figure of 75 participants, started 2024-09-01 and due to reach its primary completion in 2026-08-31. Interventions recorded: FOLFIRI + Vemurafenib + Cetuximab; FOLFIRI ± Bevacizumab. Conditions listed: Colorectal Carcinoma. Primary outcome: Objective response rate. Colorectal eligibility wording from the registry: \"* Patients with advanced colorectal adenocarcinoma confirmed by histology or cytology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06603376","url":"https://clinicaltrials.gov/study/NCT06603376"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06603376","phase":"2","setting":"A Randomized, Multicenter, Controlled Study of Irinotecan Hydrochloride Liposome Injection (II) Combined with Fluorouracil, Folinic Acid, Vermofenib and Cetuximab in First-line Treatment of BRAFV600E Mutated Advanced Colorectal Cancer","sponsor":"Shanghai Changzheng Hospital","started":"2024-09-01","startedType":"actual","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07238283","kind":"trial","name":"Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial of Leucovorin (folinic acid), Oxaliplatin and Gemcitabine in pancreatic ductal adenocarcinoma, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer is a phase 3 interventional study registered as NCT07238283 by Jiangsu HengRui Medicine Co., Ltd., with 662 participants planned, started 2025-12-02 and due to reach its primary completion in 2028-10. Interventions recorded: Irinotecan Hydrochloride Liposome Injection (II); Oxaliplatin; 5Fluorouracil; Calcium folinate and nab-paclitaxel; gemcitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07238283","url":"https://clinicaltrials.gov/study/NCT07238283"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["leucovorin","oxaliplatin","gemcitabine"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07238283","phase":"3","setting":"Irinotecan Hydrochloride Liposome Injection (II) in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Nab-paclitaxel in Combination With Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-12-02","startedType":"actual","enrolled":662,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06172036","kind":"trial","name":"Irinotecan Liposome for Resectable Pancreatic Cancer With or Without Addebelizumab","aka":["CAPT-02"],"tldr":"A phase 2 trial of cAPOX (capecitabine, oxaliplatin), fluorouracil (5-FU) and leucovorin (folinic acid) in pancreatic cancer, run by Zhejiang University, not yet recruiting.","summary":"Irinotecan Liposome for Resectable Pancreatic Cancer With or Without Addebelizumab is a phase 2, randomised interventional study registered as NCT06172036 by Zhejiang University, with a registry enrolment figure of 180 participants, started 2024-01-20 and due to reach its primary completion in 2026-01-20. Interventions recorded: irinotecan liposome + oxaliplatin + 5-FU / LV; Adebellizumab. Conditions listed: Neoadjuvant Chemotherapy; Resectable Pancreatic Cancer. Primary outcome: 12-month EFS rate. Pancreatic eligibility wording from the registry: \"V2 version), multidisciplinary and imaging evaluation for patients with resectable pancreatic cancer, resectable defined as: by imaging examination, the criteria of radical resection of tumor is no distant metastasis, the artery (trunk celiac, superior mesenteric artery or common hepatic artery), an\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06172036","url":"https://clinicaltrials.gov/study/NCT06172036"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capox","fluorouracil","leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06172036","phase":"2","setting":"A Multicenter, Multi-cohort, Randomized, Phase II Study of Irinotecan Liposome Combined With 5-FU / LV and Oxaliplatin for Resectable Pancreatic Cancer With or Without Addebelizumab","sponsor":"Zhejiang University","started":"2024-01-20","startedType":"estimated","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06513455","kind":"trial","name":"Irinotecan Liposome，Albumin Paclitaxel and Gemcitabine First-line Treatment for Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of nab-paclitaxel and gemcitabine in pancreatic cancer, run by Harbin Medical University, not yet recruiting.","summary":"Irinotecan Liposome，Albumin Paclitaxel and Gemcitabine First-line Treatment for Pancreatic Cancer is a phase 1/2, randomised interventional study registered as NCT06513455 by Harbin Medical University, with a registry enrolment figure of 132 participants, started 2024-09-01 and due to reach its primary completion in 2027-06-30. Interventions recorded: Irinotecan liposome（40mg/m2）; Nab-paclitaxel; Gemcitabine; Irinotecan Liposome（60mg/m2）. Conditions listed: Pancreatic Cancer. Primary outcome: MTD /DLT (phase I); ORR(phase II). Pancreatic eligibility wording from the registry: \"Patients with pancreatic cancer diagnosed by histology or cytology;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06513455","url":"https://clinicaltrials.gov/study/NCT06513455"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["nab-paclitaxel","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06513455","phase":"1/2","setting":"Irinotecan Liposome Combined With Albumin Paclitaxel and Gemcitabine as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer","sponsor":"Harbin Medical University","started":"2024-09-01","startedType":"estimated","enrolled":132,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06763029","kind":"trial","name":"Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer","aka":["VICPROIRI"],"tldr":"A phase 2 trial of cetuximab in colorectal cancer, run by Fudan University, now recruiting.","summary":"Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT06763029 by Fudan University, with a registry enrolment figure of 36 participants, started 2025-02-26 and due to reach its primary completion in 2026-12-31. Interventions recorded: Irinotecan liposomes combined with cetuximab + vermofenib. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Objective response rate. Colorectal eligibility wording from the registry: \"* Colorectal adenocarcinoma was confirmed by histological or cytopathological examination, and RAS wild /BRAF V600E mutation was detected by PCR or NGS;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06763029","url":"https://clinicaltrials.gov/study/NCT06763029"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","braf-v600e-colorectal"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06763029","phase":"2","setting":"Phase II Exploratory Study of Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced RAS Wild /BRAF Mutated Colorectal Cancer","sponsor":"Fudan University","started":"2025-02-26","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07074353","kind":"trial","name":"Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer","aka":["CinClare-2"],"tldr":"A phase 3 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Zhejiang Cancer Hospital, not yet recruiting.","summary":"Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT07074353 by Zhejiang Cancer Hospital, with a registry enrolment figure of 360 participants, started 2025-07-20 and due to reach its primary completion in 2028-04-01. Interventions recorded: NALIRI; LCRT; FOLFOX. Conditions listed: Locally Advanced Rectal Cancer. Primary outcome: Complete Response rate（CR）. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07074353","url":"https://clinicaltrials.gov/study/NCT07074353"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07074353","phase":"3","setting":"A Randomized, Multicenter Clinical Study of Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer","sponsor":"Zhejiang Cancer Hospital","started":"2025-07-20","startedType":"estimated","enrolled":360,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07356973","kind":"trial","name":"Irinotecan-ChemoSeed in Surgically Resectable Glioblastoma","aka":["OPTICAL"],"tldr":"A phase 2 trial of irinotecan-ChemoSeed implementation into the resection cavity after surgical resection of GBM in glioma & glioblastoma, run by CRISM Therapeutics LTD, now recruiting.","summary":"Irinotecan-ChemoSeed in Surgically Resectable Glioblastoma is a phase 2 interventional study registered as NCT07356973 by CRISM Therapeutics LTD, with 147 participants planned, started 2026-08-20 and due to reach its primary completion in 2029-05. Interventions recorded: irinotecan-ChemoSeed implementation into the resection cavity after surgical resection of GBM.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07356973","url":"https://clinicaltrials.gov/study/NCT07356973"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["irinotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07356973","phase":"2","setting":"Open-label Phase 2 Safety and Efficacy Trial of Irinotecan-ChemoSeed Administered Directly Into the Resection Margin in Patients With Surgically Resectable Glioblastoma","sponsor":"CRISM Therapeutics LTD","started":"2026-08-20","startedType":"actual","enrolled":147,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06202001","kind":"trial","name":"Irinotecan, TAS-102 Plus Bevacizumab as a Second-Line Therapy in mCRC Patients","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"Irinotecan, TAS-102 Plus Bevacizumab as a Second-Line Therapy in mCRC Patients is a phase 1/2, interventional study registered as NCT06202001 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 70 participants, started 2022-10-01 and due to reach its primary completion in 2025-09-30. Interventions recorded: Irinotecan, Trifluridine/tipiracil (TAS-102) plus Bevacizumab. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Objective Response Rate (ORR). Colorectal eligibility wording from the registry: \"Colorectal adenocarcinoma confirmed histologically or histopathologically\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06202001","url":"https://clinicaltrials.gov/study/NCT06202001"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06202001","phase":"1/2","setting":"Phase I/II Study of Irinotecan Plus Trifluridine/Tipiracil (TAS-102) in Combination With Bevacizumab as a Second-Line Therapy for Patients With Metastatic Colorectal Cancer (mCRC)","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2022-10-01","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06047015","kind":"trial","name":"Irreversible Electroporation (NanoKnife ®) and Immunotherapy for the Treatment of Stage IV Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by University of Saskatchewan, not yet recruiting.","summary":"Irreversible Electroporation (NanoKnife ®) and Immunotherapy for the Treatment of Stage IV Colorectal Cancer is a phase 1/2, interventional study registered as NCT06047015 by University of Saskatchewan, with a registry enrolment figure of 12 participants, started 2025-07 and due to reach its primary completion in 2027-12. Interventions recorded: IRE plus checkpoint inhibitor; IRE plus Checkpoint Inhibitor plus CpG-ODN. Conditions listed: Liver Metastasis Colon Cancer. Primary outcome: Complications; Complications; Abscopal effect: percent change in non-treated colorectal liver metastasis.. Colorectal eligibility wording from the registry: \"Biopsy-proven colorectal liver metastases with at least one measuring \\< 3\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06047015","url":"https://clinicaltrials.gov/study/NCT06047015"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06047015","phase":"1/2","setting":"Immune Response to Irreversible Electroporation (NanoKnife ®) and a Checkpoint Inhibitor With or Without CpG Oligodeoxynucleotides for the Treatment of Stage IV Colorectal Cancer","sponsor":"University of Saskatchewan","started":"2025-07","startedType":"estimated","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05720338","kind":"trial","name":"Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?","aka":[],"tldr":"A phase 3 trial in pancreatic cancer, run by Case Comprehensive Cancer Center, now recruiting.","summary":"Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy? is a phase 3, randomised interventional study registered as NCT05720338 by Case Comprehensive Cancer Center, with a registry enrolment figure of 234 participants, started 2023-04-13 and due to reach its primary completion in 2026-12-31. Interventions recorded: 19 French Blake Drain. Conditions listed: Cyst of Pancreas; Pancreatectomy; Pancreas Neoplasm. Primary outcome: Composite endpoint comparison; Composite endpoint comparison; Composite endpoint comparison. Pancreatic eligibility wording from the registry: \"* Subjects must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05720338","url":"https://clinicaltrials.gov/study/NCT05720338"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05720338","phase":"3","setting":"Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial","sponsor":"Case Comprehensive Cancer Center","started":"2023-04-13","startedType":"actual","enrolled":234,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05946603","kind":"trial","name":"IS-002 Phase 2 Prostate Cancer Study","aka":[],"tldr":"A phase 2 trial of Intraoperative fluorescence and Cerenkov imaging systems in Prostate cancer, run by Intuitive Surgical, completed.","summary":"IS-002 Phase 2 Prostate Cancer Study is a phase 2 interventional study registered as NCT05946603 by Intuitive Surgical, with 59 participants recorded, started 2023-06-16 and reaching its primary completion in 2024-05-21. Interventions recorded: Administration of IS-002, Firefly fluorescent imaging, robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection. Conditions recorded: Prostate Cancer.\n\nLinked to the technology Intraoperative fluorescence and Cerenkov imaging systems because the registry names it (\"firefly\") among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05946603","url":"https://clinicaltrials.gov/study/NCT05946603"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["intraoperative-fluorescence-imaging-systems"],"targets":[],"drugs":[],"companies":["intuitive-surgical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05946603","phase":"2","setting":"Phase 2 Multi-Center Randomized Controlled Feasibility Study of IS-002 in Subjects Undergoing Robotic-Assisted Radical Prostatectomy Using the da Vinci® Surgical System With Firefly® Fluorescence Imaging","sponsor":"Intuitive Surgical","started":"2023-06-16","startedType":"actual","enrolled":59,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04270409","kind":"trial","name":"Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma","aka":[],"tldr":"A phase 3 trial of Isatuximab, Lenalidomide and Dexamethasone in multiple myeloma, run by Sanofi, active and no longer recruiting.","summary":"Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma is a phase 3 interventional study registered as NCT04270409 by Sanofi, with 337 participants enrolled, started 2020-06-16 and due to reach its primary completion in 2030-10-14. Interventions recorded: Isatuximab SAR650984, Lenalidomide, Dexamethasone, Montelukast or equivalent, Acetaminophen and Diphenhydramine or equivalent.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04270409","url":"https://clinicaltrials.gov/study/NCT04270409"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","smouldering-myeloma"],"sections":[],"technologies":["antiemetic-therapy","monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["isatuximab","lenalidomide","dexamethasone"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04270409","phase":"3","setting":"A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma","sponsor":"Sanofi","started":"2020-06-16","startedType":"actual","enrolled":337,"enrolledBasis":"registry","outcomes":[]},{"id":"isg-sts-1001","kind":"trial","name":"ISG-STS 1001","aka":[],"tldr":"Standard anthracycline-ifosfamide before surgery beat subtype-tailored chemotherapy, and indirectly showed neoadjuvant chemotherapy helps high-risk sarcoma.","summary":"ISG-STS 1001, trial NCT01710176 sponsored by the Italian Sarcoma Group and published in Lancet Oncology in 2017, found that standard neoadjuvant epirubicin and ifosfamide beat subtype-tailored chemotherapy in high-risk localised soft-tissue sarcoma of the extremities and trunk, and indirectly showed that neoadjuvant chemotherapy helps in this setting. It randomised 287 patients and was stopped early when disease-free and overall survival at 46 months favoured the standard arm, and long-term follow-up confirmed the benefit against historical controls, establishing three cycles of neoadjuvant anthracycline and ifosfamide for grade 3, deep tumours over five centimetres. Whether tailored regimens fail because the histotypes were wrong or the drugs were weaker is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01710176","url":"https://clinicaltrials.gov/study/NCT01710176"}],"tags":[],"related":[],"cancers":["sarcoma","extremity-soft-tissue-sarcoma","undifferentiated-pleomorphic-sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["ifosfamide"],"companies":["italian-sarcoma-group"],"institutions":[],"pathways":[],"terms":["fnclcc-grade","sarcoma-histotype-tailoring"],"trials":[],"people":["alessandro-gronchi"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01710176","phase":"3","setting":"High-risk localised soft-tissue sarcoma of extremities/trunk: neoadjuvant epirubicin-ifosfamide vs histotype-tailored chemotherapy","sponsor":"Italian Sarcoma Group","result":"Standard arm DFS HR ~0.45 vs tailored; OS 89% vs 64% at 46 months.","started":"2011-06-01","startedType":"actual","yearReported":2017,"enrolled":287,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 46 months","unit":"%","arms":[{"name":"Epirubicin-ifosfamide","n":142,"value":89},{"name":"Histotype-tailored","n":145,"value":64,"note":"HR for death 2.687 (tailored vs standard)"}],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30334-0/fulltext"}]},{"id":"istopmm","kind":"trial","name":"iStopMM","aka":[],"tldr":"iStopMM screened an entire nation for the precursor of myeloma, to learn whether finding it early saves lives or just causes worry.","summary":"iStopMM, trial NCT03327597 sponsored by the University of Iceland, screened an entire nation for monoclonal gammopathy of undetermined significance, the precursor of myeloma, to learn whether finding it early saves lives or just causes worry. About 75,000 Icelanders over forty took part, around 3,700 with MGUS were identified and randomised to no follow-up, standard follow-up or intensive follow-up, and early results between 2023 and 2025 show more smouldering myeloma and treatable lymphoproliferative disease detected in the intensive arm, with mortality outcomes pending. OnCo links it to multiple myeloma, the smouldering myeloma and MGUS term and Sigurdur Y. Kristinsson. Whether screening for a precursor condition improves survival or only diagnoses is the question it was designed to answer.","status":"active","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03327597","url":"https://clinicaltrials.gov/study/NCT03327597"}],"tags":[],"related":[],"cancers":["multiple-myeloma","smouldering-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["smoldering-myeloma"],"trials":[],"people":["sigurdur-kristinsson"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03327597","phase":"observational","setting":"Population screening of Icelanders over 40 for MGUS with randomised follow-up strategies","sponsor":"University of Iceland","started":"2016-09-01","startedType":"actual","enrolled":75422,"enrolledBasis":"registry","outcomes":[{"endpoint":"Prevalence of smouldering multiple myeloma among screened residents aged 40 or older","unit":"%","arms":[{"name":"Screened Icelandic residents (serum protein electrophoresis, immunofixation and free light chains)","n":75422,"value":0.53,"note":"80,759 consented, 75,422 screened; 0.67% in men and 0.39% in women; 193 individuals with smouldering myeloma, median age 70. The randomised primary endpoints (outcomes by follow-up strategy) have not yet been reported"}],"ci":[0.49,0.57],"source":"https://doi.org/10.1038/s41591-022-02183-6"}],"replication":"The only nationwide screening cohort for myeloma precursors, so the prevalence figure has no direct replicate; it is roughly five times higher than earlier clinic-based estimates. The randomised comparison of follow-up strategies is unreported and will decide whether screening should be adopted."},{"id":"nct06634875","kind":"trial","name":"Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)","aka":[],"tldr":"A phase 2 trial of isunakinra in colorectal cancer, run by Buzzard Pharmaceuticals, now recruiting.","summary":"Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS) is a phase 2 interventional study registered as NCT06634875 by Buzzard Pharmaceuticals, with 20 participants planned, started 2025-01-30 and due to reach its primary completion in 2026-06. Interventions recorded: isunakinra.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06634875","url":"https://clinicaltrials.gov/study/NCT06634875"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06634875","phase":"2","setting":"A Phase IIa, Non-Randomized, Open-Label Dose Expansion Trial of Isunakinra in Combination With Pembrolizumab in Patients With Metastatic or Unresectable, Locally Advanced Colorectal Cancer","sponsor":"Buzzard Pharmaceuticals","started":"2025-01-30","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04447235","kind":"trial","name":"Ivermectin plus losartan for COVID-19 in cancer patients (ICESP phase 2, terminated)","aka":[],"tldr":"This Brazilian trial tested ivermectin against COVID-19 in people with cancer, not against the cancer itself. It was stopped early because an interim analysis found no difference between the drug and placebo.","summary":"The trial opened on 23 July 2020, planned 176 patients and was terminated after enrolling 77 (ClinicalTrials.gov NCT04447235). The registry gives the reason for stopping as 'futility analysis has demonstrated no difference between arms' (ClinicalTrials.gov NCT04447235). No results are posted and no publication was found on Europe PMC (ClinicalTrials.gov NCT04447235). It appears on this page because it is one of only four ivermectin studies on ClinicalTrials.gov that name cancer, and it says nothing about ivermectin as a cancer treatment (ClinicalTrials.gov NCT04447235).","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04447235","url":"https://clinicaltrials.gov/study/NCT04447235"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":["ivermectin"],"companies":[],"institutions":["icesp"],"pathways":[],"terms":["futility"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo agent (Claude Fable 5.1)","editedOn":"2026-09-24","note":"Written from cached ClinicalTrials.gov v2, Europe PMC, DailyMed, Drugs@FDA and WHO eEML responses; no figure appears without its source link."},"nct":"NCT04447235","phase":"2","setting":"Patients with active cancer and newly diagnosed COVID-19: randomised, double-blind, placebo-controlled; a single 12 mg dose of ivermectin then losartan 50 mg daily for 15 days versus placebo; primary endpoint intensive care admission, mechanical ventilation or death within 28 days","sponsor":"Instituto do Câncer do Estado de São Paulo","result":"Terminated for futility after 77 of a planned 176 patients; no difference between arms on the interim analysis, per the registry; no publication (ClinicalTrials.gov NCT04447235).","started":"2020-07-23","startedType":"actual","enrolled":77,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05318469","kind":"trial","name":"Ivermectin with balstilimab or pembrolizumab in metastatic triple-negative breast cancer (Cedars-Sinai phase 1/2)","aka":[],"tldr":"A small single-centre trial in Los Angeles is testing whether adding a worm medicine to an immunotherapy antibody is safe, and then whether it shrinks triple-negative breast cancer that has spread. It opened in 2023 and has not reported.","summary":"The study opened on 13 October 2023, plans 34 patients and expects to reach its primary completion in October 2026 (ClinicalTrials.gov NCT05318469). Phase 1 finds the recommended phase 2 dose of ivermectin by counting adverse events, and phase 2 measures the objective response rate, with progression-free survival, overall survival and duration of response as secondary endpoints (ClinicalTrials.gov NCT05318469). No results have been posted and no publication is indexed on Europe PMC (ClinicalTrials.gov NCT05318469). The registry entry for the later ICONIC trial reports that among the first nine treated patients no treatment-related serious adverse events were observed (ClinicalTrials.gov NCT07487805).","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05318469","url":"https://clinicaltrials.gov/study/NCT05318469"},{"label":"ClinicalTrials.gov NCT07487805","url":"https://clinicaltrials.gov/study/NCT07487805"}],"tags":[],"related":[],"cancers":["tnbc"],"sections":[],"technologies":["checkpoint-inhibitor","drug-repurposing"],"targets":[],"drugs":["ivermectin","balstilimab","pembrolizumab"],"companies":["agenus","merck"],"institutions":["cedars-sinai-cancer"],"pathways":[],"terms":["rp2d","orr","single-arm"],"trials":[],"people":[],"bottlenecks":["b-generic-repurposing"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo agent (Claude Fable 5.1)","editedOn":"2026-09-24","note":"Written from cached ClinicalTrials.gov v2, Europe PMC, DailyMed, Drugs@FDA and WHO eEML responses; no figure appears without its source link."},"nct":"NCT05318469","phase":"1/2","setting":"Metastatic triple-negative breast cancer: single-arm phase 1 dose finding then phase 2, ivermectin by mouth on days 1 to 3 of each week with balstilimab or pembrolizumab intravenously on day 1 of each 21-day cycle","sponsor":"Yuan Yuan, sponsor-investigator at Cedars-Sinai Medical Center, with Agenus and Gateway for Cancer Research","result":"No results posted (ClinicalTrials.gov NCT05318469). The ICONIC registry entry reports no treatment-related serious adverse events among the first nine treated patients (ClinicalTrials.gov NCT07487805).","started":"2023-10-13","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07405190","kind":"trial","name":"Ivonescimab Alone And With Carboplatin/Pemetrexed For NSCLC","aka":[],"tldr":"A phase 2 trial of ivonescimab, carboplatin and pemetrexed in lung cancer, run by Massachusetts General Hospital, now recruiting.","summary":"Ivonescimab Alone And With Carboplatin/Pemetrexed For NSCLC is a phase 2, interventional study registered as NCT07405190 by Massachusetts General Hospital, with a registry enrolment figure of 46 participants, started 2026-05-01 and due to reach its primary completion in 2028-03-01. Interventions recorded: Ivonescimab; carboplatin; pemetrexed. Conditions listed: Lung Cancer (NSCLC); Lung Cancer Non-Small Cell Cancer (NSCLC); Lung Cancer (Non-Small Cell); Lung Cancer - Non Small Cell; Lung Cancer Non Small Cell; Genomic Alterations. Primary outcome: Objective Response Rate (ORR) of Ivonescimab Monotherapy; Objective Response Rate (ORR) of Ivonescimab plus Carboplatin/Pemetrexed. Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC not amenable to curative resection or radiation\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07405190","url":"https://clinicaltrials.gov/study/NCT07405190"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","bispecific-antibody","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["ivonescimab","carboplatin","pemetrexed"],"companies":["summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07405190","phase":"2","setting":"A Phase II Study of Ivonescimab as Monotherapy or in Combination With Platinum/Pemetrexed Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring Actionable Genomic Alterations (AGAs)","sponsor":"Massachusetts General Hospital","started":"2026-05-01","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06928389","kind":"trial","name":"Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of Ivonescimab, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by Akeso, now recruiting.","summary":"Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06928389 by Akeso, with 536 participants planned, started 2025-07-08 and due to reach its primary completion in 2027-05. Interventions recorded: Ivonescimab, docetaxel, Placebo, docetaxel. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06928389","url":"https://clinicaltrials.gov/study/NCT06928389"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["ivonescimab","docetaxel"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06928389","phase":"3","setting":"A Randomized, Double-blind, Multicenter Phase 3 Clinical Trial of Ivonescimab Versus Placebo, Combined With Docetaxel in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) That Has Progressed on or After PD-(L)1 Inhibitor-based Therapy","sponsor":"Akeso","started":"2025-07-08","startedType":"actual","enrolled":536,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06993025","kind":"trial","name":"Ivonescimab in Combination With Liposomal Irinotecan and 5-FU/LV in Potentially Resectable Biliary Tract Malignancies","aka":[],"tldr":"A phase 2 trial of ivonescimab, fluorouracil and liposomal irinotecan in gallbladder cancer and other biliary tract cancers, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"Ivonescimab in Combination With Liposomal Irinotecan and 5-FU/LV in Potentially Resectable Biliary Tract Malignancies is a phase 2 interventional study registered as NCT06993025 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 30 participants, started 2025-05-25 and due to reach its primary completion in 2026-04-25. Interventions recorded: Ivonescimab+chemotherapy. Conditions listed: Biliary Tract Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06993025","url":"https://clinicaltrials.gov/study/NCT06993025"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["ivonescimab","fluorouracil","liposomal-irinotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06993025","phase":"2","setting":"A Phase II, Open-Label, Single-Arm, Single-Center Study of Ivonescimab in Combination With Liposomal Irinotecan and 5-Fluorouracil/Leucovorin in Patients With Potentially Resectable Biliary Tract Malignancies","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2025-05-25","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06848842","kind":"trial","name":"Ivonescimab Plus Chemotherapy in Patients With Initially Unresectable Colorectal Cancer Liver Metastases","aka":[],"tldr":"A phase 2 trial of ivonescimab in colorectal cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"Ivonescimab Plus Chemotherapy in Patients With Initially Unresectable Colorectal Cancer Liver Metastases is a phase 2, interventional study registered as NCT06848842 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 40 participants, started 2025-09-18 and due to reach its primary completion in 2027-06. Interventions recorded: Ivonescimab plus chemotherapy. Conditions listed: Colorectal Liver Metastases. Primary outcome: Objective Response Rate; Treatment-Emergent Adverse Events. Colorectal eligibility wording from the registry: \"Histologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06848842","url":"https://clinicaltrials.gov/study/NCT06848842"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06848842","phase":"2","setting":"A Phase II Clinical Study of Ivonescimab Plus CAPOX Regimen in Patients With Initially Unresectable Colorectal Cancer Liver-only Metastases","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2025-09-18","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06991491","kind":"trial","name":"Ivonescimab With GnP and SBRT in Patients With Metastatic Pancreatic Cancer (WGOG-PAN 004)","aka":["WGOG-PAN 004"],"tldr":"A phase 2 trial of ivonescimab in pancreatic cancer, run by West China Hospital, not yet recruiting.","summary":"Ivonescimab With GnP and SBRT in Patients With Metastatic Pancreatic Cancer (WGOG-PAN 004) is a phase 2, interventional study registered as NCT06991491 by West China Hospital, with a registry enrolment figure of 29 participants, started 2025-06-01 and due to reach its primary completion in 2026-06-30. Interventions recorded: GnP in combination with Ivonescimab and SBRT. Conditions listed: Pancreatic Cancer. Primary outcome: 6-month-PFS rate. Pancreatic eligibility wording from the registry: \"Patients with pathologically confirmed metastatic pancreatic cancer;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06991491","url":"https://clinicaltrials.gov/study/NCT06991491"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","sbrt"],"targets":[],"drugs":["ivonescimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06991491","phase":"2","setting":"Ivonescimab With GnP and SBRT in Patients With Metastatic Pancreatic Cancer (WGOG-PAN 004): an Open-label, Single-arm, Phase II Trial of First-line Multimodal Therapy With Spatial Tumor Immune Microenvironment Analysis","sponsor":"West China Hospital","started":"2025-06-01","startedType":"estimated","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06491472","kind":"trial","name":"Ivonescimab(AK112/SMT112) in Combination With Stereotactic Body Radiation Therapy and Chemotherapy in Patients With Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of ivonescimab, gemcitabine and nab-paclitaxel in pancreatic cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, now recruiting.","summary":"Ivonescimab(AK112/SMT112) in Combination With Stereotactic Body Radiation Therapy and Chemotherapy in Patients With Pancreatic Cancer is a phase 2, interventional study registered as NCT06491472 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 36 participants, started 2024-07-15 and due to reach its primary completion in 2026-07-15. Interventions recorded: Ivonescimab; Gemcitabine; Nab paclitaxel; SBRT. Conditions listed: Pancreatic Cancer. Primary outcome: Objective Response Rate(ORR). Pancreatic eligibility wording from the registry: \"* Histologically- or cytologically-confirmed diagnosis of pancreatic ductal adenocarcinoma (including adenosquamous carcinoma)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06491472","url":"https://clinicaltrials.gov/study/NCT06491472"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","sbrt"],"targets":[],"drugs":["ivonescimab","gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06491472","phase":"2","setting":"Efficacy and Safety of Ivonescimab(AK112/SMT112) in Combination With Stereotactic Body Radiation Therapy and Chemotherapy in Patients With Pancreatic Cancer：A Single-arm, Open-label, Phase II Clinical Study","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2024-07-15","startedType":"estimated","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06127407","kind":"trial","name":"Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen","aka":["CHONQUER"],"tldr":"A phase 3 trial of Ivosidenib in sarcomas, run by Servier Bio-Innovation LLC, now recruiting.","summary":"Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen is a phase 3 interventional study registered as NCT06127407 by Servier Bio-Innovation LLC, with 136 participants planned, started 2024-07-09 and due to reach its primary completion in 2028-02-01. Interventions recorded: Ivosidenib 500mg and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06127407","url":"https://clinicaltrials.gov/study/NCT06127407"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma","chondrosarcoma"],"sections":[],"technologies":["epigenetic-drugs","idh-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["ivosidenib"],"companies":["servier"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06127407","phase":"3","setting":"A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib in Participants ≥18 Years of Age With Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen","sponsor":"Servier Bio-Innovation LLC","started":"2024-07-09","startedType":"actual","enrolled":136,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07809893","kind":"trial","name":"Ivosidenib Plus mFOLFOXIRI and Celecoxib for BRAF-targeted Therapy-refractory BRAF V600E-mutant Colorectal Cancer Patients","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Ivosidenib Plus mFOLFOXIRI and Celecoxib for BRAF-targeted Therapy-refractory BRAF V600E-mutant Colorectal Cancer Patients is a phase 2, interventional study registered as NCT07809893 by Sun Yat-sen University, with a registry enrolment figure of 45 participants, started 2026-08-10 and due to reach its primary completion in 2027-12-31. Interventions recorded: Ivonescimab +mFOLFOXIRI +celecoxib. Conditions listed: Colorectal Cancer. Primary outcome: Objective response rate (ORR). Colorectal eligibility wording from the registry: \"Colorectal adenocarcinoma with definite histological evidence, with evidence of distant metastasis;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07809893","url":"https://clinicaltrials.gov/study/NCT07809893"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","braf-v600e-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07809893","phase":"2","setting":"Ivosidenib Plus mFOLFOXIRI and Celecoxib as a Treatment for BRAF-targeted Therapy-refractory BRAF V600E-mutant Colorectal Cancer Patients: a Phase II Study","sponsor":"Sun Yat-sen University","started":"2026-08-10","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06549946","kind":"trial","name":"Ixovex-1 Single Agent and Combination Therapy","aka":["IXACT"],"tldr":"A phase 1/2 trial of Pembrolizumab in head and neck squamous cell carcinoma, run by Psivac Ltd, now recruiting.","summary":"Ixovex-1 Single Agent and Combination Therapy is a phase 1/2 interventional study registered as NCT06549946 by Psivac Ltd, with 18 participants planned, started 2024-12-17 and due to reach its primary completion in 2027-01-30. Interventions recorded: Ixovex-1 and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06549946","url":"https://clinicaltrials.gov/study/NCT06549946"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["iqvia"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06549946","phase":"1/2","setting":"A Phase I/II Open-label, Clinical Trial of Intratumoural Ixovex-1 as Single Agent Therapy or in Combination With Pembrolizumab in Palpable Solid Tumours","sponsor":"Psivac Ltd","started":"2024-12-17","startedType":"actual","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"izabright-breast01","kind":"trial","name":"IZABRIGHT-Breast01","aka":[],"tldr":"IZABRIGHT-Breast01 is the global first-line trial of the EGFR×HER3 bispecific ADC in triple-negative breast cancer.","summary":"IZABRIGHT-Breast01, trial NCT06926868 sponsored by Bristol Myers Squibb, is the global first-line trial of the EGFR by HER3 bispecific antibody-drug conjugate izalontamab brengitecan in metastatic triple-negative breast cancer patients ineligible for PD-1 or PD-L1 inhibitors, comparing it with chemotherapy. It plans to enrol 570 patients, directly competes for the populations studied in ASCENT-03 and TROPION-Breast02, and is ongoing with no results. OnCo links it to triple-negative breast cancer, izalontamab brengitecan and the TNBC roadmap. Whether a bispecific ADC that succeeded in a Chinese phase 3 can match or beat the approved TROP2 ADCs in a global first-line population is the question it exists to answer.","status":"recruiting","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT06926868","url":"https://clinicaltrials.gov/study/NCT06926868"}],"tags":[],"related":[],"cancers":["tnbc"],"sections":[],"technologies":["adc","bispecific-adc"],"targets":[],"drugs":["izalontamab-brengitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06926868","phase":"2/3","setting":"First-line metastatic TNBC ineligible for PD-(L)1 inhibitors: iza-bren vs chemotherapy","sponsor":"BMS","started":"2025-09-11","startedType":"actual","enrolled":570,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing; no results."},{"id":"j-alex","kind":"trial","name":"J-ALEX","aka":[],"tldr":"The Japanese trial that beat crizotinib with alectinib first, at half the dose used everywhere else, and was stopped early because the difference was so large.","summary":"J-ALEX recruited 207 ALK inhibitor-naive Japanese patients at 41 sites between November 2013 and August 2015 and randomised them 1:1 to alectinib 300 mg twice daily (103) or crizotinib 250 mg twice daily (104), stratified by performance status, treatment line and disease stage. The alectinib dose is half the 600 mg twice daily used in ALEX and ALESIA, because Japanese pharmacokinetic work had settled on it.\n\nAt the second interim analysis (data cutoff 3 December 2015) the independent data monitoring committee stopped the trial: 24 patients had discontinued alectinib against 61 on crizotinib, mostly for lack of efficacy or adverse events, and independently reviewed progression-free survival strongly favoured alectinib.\n\nJ-ALEX reported before ALEX and is the reason Japan approved alectinib first line at 300 mg twice daily while the rest of the world uses 600 mg. The two doses have never been compared head to head, and whether the higher one is necessary is still open.","status":"positive","asOf":"2026-09-25","links":[{"label":"J-ALEX (Lancet 2017)","url":"https://doi.org/10.1016/S0140-6736(17)30565-2"},{"label":"Japan Pharmaceutical Information Center (the registry that held JapicCTI-132316; its record address now redirects to the registry home page)","url":"https://www.clinicaltrials.jp/"}],"tags":[],"related":[],"cancers":["alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["alectinib","crizotinib"],"companies":["chugai"],"institutions":[],"pathways":[],"terms":["tki-term","brain-metastases"],"trials":["alex","alesia","profile-1014"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"ALK inhibitor-naive Japanese patients with ALK-positive non-small-cell lung cancer, chemotherapy-naive or after one regimen: alectinib 300 mg twice daily versus crizotinib 250 mg twice daily, with progression-free survival by an independent review facility as the primary endpoint","sponsor":"Chugai Pharmaceutical","result":"Stopped at the second interim analysis for a large progression-free survival advantage of alectinib over crizotinib.","yearReported":2017,"enrolled":207,"enrolledBasis":"randomised","enrolledNote":"207 patients were recruited at 41 Japanese sites; the trial is registered with the Japan Pharmaceutical Information Center as JapicCTI-132316 and has no ClinicalTrials.gov record, so there is no registry figure.","outcomes":[],"replication":"ALEX reproduced the result globally at 600 mg twice daily, and ALESIA reproduced it in Chinese, Korean and Thai patients at the same 600 mg dose."},{"id":"nct06416410","kind":"trial","name":"JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation","aka":[],"tldr":"A phase 3 trial testing Sitneprotafib in non-small-cell lung cancer, now recruiting.","summary":"JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation is a phase 3 interventional study registered as NCT06416410, led by Allist Pharmaceuticals, and recruiting on the registry. Official title: An Open-label, Randomised, Positive Control, Multicenter Phase III Clinical Study. Evaluating JAB-21822 Combined With JAB-3312 Compared Tislelizumab Combined With Pemetrexed + Carboplatin in the First Line for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With KRAS p.G12C Mutation. Planned enrolment is 392 participants (estimated). The study started in 2024-08-07 and primary completion is expected in 2029-09-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06416410","url":"https://clinicaltrials.gov/study/NCT06416410"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["sitneprotafib"],"companies":["allist"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06416410","phase":"3","setting":"An Open-label, Randomized, Positive Control, Multicenter Phase III Clinical Study. Evaluating JAB-21822 Combined With JAB-3312 Compared Tislelizumab Combined With Pemetrexed + Carboplatin in the First Line for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With KRAS p.G12C Mutation","sponsor":"Allist Pharmaceuticals","started":"2024-08-07","startedType":"actual","enrolled":392,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05194995","kind":"trial","name":"JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation","aka":[],"tldr":"A phase 1/2 trial of Glecirasib, Cetuximab in colorectal cancer, run by Allist Pharmaceuticals, Inc., active and no longer recruiting.","summary":"JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation is a phase 1/2 interventional study registered as NCT05194995 by Allist Pharmaceuticals, Inc., with 48 participants enrolled, started 2022-02-17 and due to reach its primary completion in 2025-04-30. Interventions recorded: JAB-21822, Cetuximab. Conditions listed: Advanced Colorectal Cancer, Small Intestinal Cancer, Appendiceal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05194995","url":"https://clinicaltrials.gov/study/NCT05194995"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","kras-g12c-colorectal"],"sections":[],"technologies":["kinase-inhibitors","kras-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["glecirasib","cetuximab"],"companies":["allist"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05194995","phase":"1/2","setting":"A Phase Ib/II Trial of JAB-21822 in Combination With Cetuximab in Patients With Advanced Colorectal Cancer, Small Intestine Cancer and Appendiceal Cancer With KRAS G12C Mutation","sponsor":"Allist Pharmaceuticals, Inc.","started":"2022-02-17","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06973564","kind":"trial","name":"JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration","aka":[],"tldr":"A phase 1/2 trial of JAB-23E73 in advanced solid tumours, run by Jacobio Pharmaceuticals Co., Ltd., now recruiting.","summary":"JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration is a phase 1/2 interventional study registered as NCT06973564 by Jacobio Pharmaceuticals Co., Ltd., with 294 participants planned, started 2025-05-29 and due to reach its primary completion in 2027-11. Interventions recorded: JAB-23E73.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06973564","url":"https://clinicaltrials.gov/study/NCT06973564"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["jacobio-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06973564","phase":"1/2","setting":"A Phase 1/2a, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JAB-23E73 in Adult Patients With Advanced Solid Tumors With KRAS Alteration","sponsor":"Jacobio Pharmaceuticals Co., Ltd.","started":"2025-05-29","startedType":"actual","enrolled":294,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05490472","kind":"trial","name":"JAB-2485 Activity in Adult Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of JAB-2485 (Aurora A inhibitor) in triple-negative breast cancer and small-cell lung cancer, run by Jacobio Pharmaceuticals Co., Ltd., now recruiting.","summary":"JAB-2485 Activity in Adult Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05490472 by Jacobio Pharmaceuticals Co., Ltd., with 102 participants planned, started 2022-12-20 and due to reach its primary completion in 2026-08. Interventions recorded: JAB-2485 (Aurora A inhibitor).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05490472","url":"https://clinicaltrials.gov/study/NCT05490472"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["jacobio-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05490472","phase":"1/2","setting":"A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors","sponsor":"Jacobio Pharmaceuticals Co., Ltd.","started":"2022-12-20","startedType":"actual","enrolled":102,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06386146","kind":"trial","name":"JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation","aka":[],"tldr":"A phase 1/2 trial of JAB-30355 in advanced solid tumours, run by Jacobio Pharmaceuticals Co., Ltd., now recruiting.","summary":"JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation is a phase 1/2 interventional study registered as NCT06386146 by Jacobio Pharmaceuticals Co., Ltd., with 144 participants planned, started 2024-07-24 and due to reach its primary completion in 2027-01. Interventions recorded: JAB-30355.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06386146","url":"https://clinicaltrials.gov/study/NCT06386146"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["jacobio-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06386146","phase":"1/2","setting":"A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-30355 in Adult Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation","sponsor":"Jacobio Pharmaceuticals Co., Ltd.","started":"2024-07-24","startedType":"actual","enrolled":144,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06731153","kind":"trial","name":"JAK1 Inhibitor Ivarmacitinib Reversing Immunotherapy Resistance in TNBC","aka":[],"tldr":"A phase 2 trial of camrelizumab and eribulin in triple-negative breast cancer, run by Fudan University, not yet recruiting.","summary":"JAK1 Inhibitor Ivarmacitinib Reversing Immunotherapy Resistance in TNBC is a phase 2, randomised interventional study registered as NCT06731153 by Fudan University, with a registry enrolment figure of 40 participants, started 2024-12 and due to reach its primary completion in 2027-06. Interventions recorded: Ivarmacitinib; Camrelizumab (SHR-1210); Eribulin. Conditions listed: Triple Negative Breast Cancer (TNBC); Metastatic Breast Cancer. Triple-negative eligibility wording from the registry: \"Metastatic or locally advanced, histologically documented TNBC;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06731153","url":"https://clinicaltrials.gov/study/NCT06731153"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["camrelizumab","eribulin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06731153","phase":"2","setting":"A Randomized, Controlled, Open-label, Phase II Clinical Study Evaluating the JAK1 Inhibitor Ivarmacitinib to Reverse Immunotherapy Resistance in Triple-negative Breast Cancer","sponsor":"Fudan University","started":"2024-12","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06868667","kind":"trial","name":"Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dex","aka":[],"tldr":"A phase 3 trial of Belantamab mafodotin, Daratumumab, Bortezomib in multiple myeloma, run by GlaxoSmithKline, active and no longer recruiting.","summary":"Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT06868667 by GlaxoSmithKline, with 24 participants enrolled, started 2021-07-28 and due to reach its primary completion in 2024-04-03. Interventions recorded: Belantamab mafodotin, Daratumumab, Bortezomib, Dexamethasone. Conditions listed: Multiple Myeloma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06868667","url":"https://clinicaltrials.gov/study/NCT06868667"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["adc","antiemetic-therapy","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["belantamab-mafodotin","daratumumab","bortezomib","dexamethasone"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06868667","phase":"3","setting":"DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma","sponsor":"GlaxoSmithKline","started":"2021-07-28","startedType":"actual","yearReported":2025,"enrolled":24,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)","n":10,"note":"The median and upper limit of 95% Confidence Interval were not estimable due to the length of follow-up in assessing the number of events.; Figures from the ClinicalTrials.gov results section (first posted 2025-05-09), not from a publication"},{"name":"Daratumumab + Bor + Dex","n":14,"value":11.1,"note":"95% CI 4.9 to NA"}],"hr":0.4,"ci":[0.11,1.52],"source":"https://clinicaltrials.gov/study/NCT06868667?tab=results"}]},{"id":"jaspac-01","kind":"trial","name":"JASPAC 01","aka":["JASPAC-01","JASPAC01"],"tldr":"JASPAC 01 found that six months of the oral fluoropyrimidine S-1 after pancreatic cancer surgery nearly doubled five-year survival compared with gemcitabine in Japanese patients, 44 against 24 percent, which made S-1 the adjuvant standard in Japan; the result has never been tested in Western patients, who metabolise the drug differently.","summary":"JASPAC 01 randomised 385 patients between April 2007 and June 2010 to gemcitabine (1,000 mg/m2 on days 1, 8 and 15 of a 28-day cycle, up to six cycles) or S-1 (40 to 60 mg twice daily by body surface area for 28 days of a 42-day cycle, up to four cycles). The trial was designed to show non-inferiority (margin 1.25) and was stopped early in September 2012 when the interim analysis met the pre-specified criteria. With follow-up to January 2016 the hazard ratio for death was 0.57 (95 percent confidence interval 0.44 to 0.72; p below 0.0001 for both non-inferiority and superiority), with five-year overall survival 44.1 percent on S-1 against 24.4 percent on gemcitabine. Grade 3 or 4 leucopenia, neutropenia and transaminase rises were commoner with gemcitabine, stomatitis and diarrhoea with S-1. S-1 (tegafur, gimeracil and oteracil) is licensed in Europe as Teysuno for gastric and colorectal cancer only, and the authors asked for the result to be confirmed in non-Asian patients before it is adopted outside Japan; the corpus's adjuvant row cites it as the Japanese standard beside modified FOLFIRINOX and gemcitabine plus capecitabine.","status":"positive","asOf":"2026-09-24","links":[{"label":"Uesaka et al., JASPAC 01 (Lancet 2016)","url":"https://doi.org/10.1016/S0140-6736(16)30583-9"},{"label":"UMIN Clinical Trials Registry UMIN000000655","url":"https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000794"},{"label":"Ueno et al., GEST: S-1 non-inferior to gemcitabine in advanced disease (JCO 2013)","url":"https://doi.org/10.1200/JCO.2012.43.3680"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["tegafur-gimeracil-oteracil","gemcitabine"],"companies":["taiho"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Resected stage I to III pancreatic ductal adenocarcinoma in Japan, R0 or R1: six cycles of adjuvant gemcitabine against four cycles of oral S-1 for six months, a non-inferiority trial with overall survival as the primary endpoint","sponsor":"Japan Adjuvant Study Group of Pancreatic Cancer (Shizuoka Cancer Center), with Taiho","result":"Five-year overall survival 44.1 percent with adjuvant S-1 against 24.4 percent with gemcitabine (hazard ratio 0.57, 95 percent confidence interval 0.44 to 0.72; p below 0.0001).","yearReported":2016,"enrolled":385,"enrolledBasis":"randomised","enrolledNote":"JASPAC 01 is registered with the UMIN Clinical Trials Registry (UMIN000000655) and has no ClinicalTrials.gov record; 385 patients were randomised at 33 Japanese hospitals and 377 formed the per-protocol population.","outcomes":[{"endpoint":"Overall survival (per-protocol population)","primary":true,"unit":"%","arms":[{"name":"Adjuvant S-1","n":187,"value":44.1,"note":"5-year rate; 95% CI 36.9 to 51.1"},{"name":"Adjuvant gemcitabine","n":190,"value":24.4,"note":"5-year rate; 95% CI 18.6 to 30.8"}],"hr":0.57,"ci":[0.44,0.72],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(16)30583-9"}]},{"id":"javelin-bladder-100","kind":"trial","name":"JAVELIN Bladder 100","aka":[],"tldr":"Starting immunotherapy right after chemotherapy, rather than waiting for relapse, lengthened survival by about seven months.","summary":"JAVELIN Bladder 100, trial NCT02603432 sponsored by Merck KGaA and Pfizer and reported in 2020, showed that starting avelumab immunotherapy immediately after platinum chemotherapy, rather than waiting for relapse, lengthened survival in advanced urothelial cancer. It randomised 700 patients without progression after four to six cycles of platinum chemotherapy to avelumab maintenance with best supportive care or supportive care alone and met its primary overall survival endpoint, making avelumab maintenance the standard after platinum for four years. OnCo links it to bladder cancer, avelumab and Thomas Powles. It was superseded rather than contradicted when EV-302 displaced platinum from first-line treatment for most patients, and it remains relevant where enfortumab vedotin plus pembrolizumab is unavailable or contraindicated.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02603432","url":"https://clinicaltrials.gov/study/NCT02603432"}],"tags":[],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["avelumab"],"companies":["merck-kgaa","pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["thomas-powles"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02603432","phase":"3","setting":"Advanced urothelial cancer without progression after 4-6 cycles of platinum chemotherapy: avelumab maintenance + best supportive care vs BSC","sponsor":"Merck KGaA / Pfizer","result":"OS 21.4 vs 14.3 months, HR 0.69.","started":"2016-04-25","startedType":"actual","yearReported":2020,"enrolled":700,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Avelumab + BSC","n":350,"value":21.4},{"name":"BSC","n":350,"value":14.3}],"hr":0.69,"ci":[0.56,0.86],"p":"0.001","source":"https://ascopubs.org/doi/10.1200/JCO.22.01792"}],"replication":"Consistent with real-world maintenance series; superseded rather than contradicted by EV-302."},{"id":"javelin-hn-100","kind":"trial","name":"JAVELIN Head and Neck 100","aka":[],"tldr":"Adding a PD-L1 blocker to curative chemoradiation did not help, the first of several such failures in head and neck cancer.","summary":"JAVELIN Head and Neck 100, trial NCT02952586 sponsored by Merck KGaA and Pfizer and reported in 2020, found that adding the PD-L1 antibody avelumab to curative chemoradiation for locally advanced head and neck cancer did not help, the first of several such failures. It randomised 697 patients to avelumab with chemoradiation followed by avelumab maintenance, or chemoradiation with placebo, and was stopped for futility with no improvement in progression-free survival. OnCo links it to head and neck cancer, modern external beam radiotherapy, immune checkpoint inhibitors, PD-L1 as a target and the pairing that places immunotherapy before surgery rather than with chemoradiation. Radiation-induced lymphopenia and steroid use are suspected to blunt the effect, which is why KEYNOTE-689 placed immunotherapy before surgery.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02952586","url":"https://clinicaltrials.gov/study/NCT02952586"},{"label":"Lancet Oncology 2021","url":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30737-3/fulltext"}],"tags":["failure","lesson:concurrent-io-with-chemoradiation"],"related":[],"cancers":["head-and-neck","hpv-negative-head-and-neck-cancer"],"sections":[],"technologies":["imrt-igrt","checkpoint-inhibitor"],"targets":["pdl1"],"drugs":[],"companies":["merck-kgaa","pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02952586","phase":"3","setting":"Locally advanced HNSCC: avelumab + chemoradiation then avelumab maintenance vs chemoradiation","sponsor":"Merck KGaA / Pfizer","result":"PFS HR 1.21; futility.","started":"2016-11-28","startedType":"actual","yearReported":2020,"enrolled":697,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Avelumab + chemoradiotherapy, then avelumab maintenance","n":350,"note":"Median not reached in either arm; stopped for futility at interim analysis"},{"name":"Placebo + chemoradiotherapy","n":347}],"hr":1.21,"ci":[0.93,1.57],"p":"0.92 (one-sided)","source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30737-3/fulltext"}],"replication":"Consistent with KEYNOTE-412 (pembrolizumab + CRT, EFS HR 0.83, not significant) and IMvoke010: concurrent PD-(L)1 blockade with definitive chemoradiotherapy has failed in three phase 3 trials."},{"id":"javelin-merkel-200","kind":"trial","name":"JAVELIN Merkel 200","aka":[],"tldr":"JAVELIN Merkel 200 showed that the PD-L1 antibody avelumab shrinks about a third of Merkel cell carcinomas that have already failed chemotherapy, most of them durably, and it produced the first approved drug for this cancer.","summary":"JAVELIN Merkel 200 was a single-arm phase 2 trial of avelumab in metastatic Merkel cell carcinoma, a rare, aggressive neuroendocrine skin cancer driven either by Merkel cell polyomavirus or by ultraviolet mutation, both of which make it visible to the immune system. Part A enrolled patients whose disease had progressed after chemotherapy; part B enrolled untreated patients.\n\nIn part A the objective response rate was 31.8 percent in 88 patients (Lancet Oncology 2016), and responses were durable where chemotherapy responses had typically lasted only months. In part B, in 116 untreated patients, the response rate was 39.7 percent with long follow-up.\n\nAvelumab received accelerated approval in March 2017, the first drug ever approved for Merkel cell carcinoma, and with KEYNOTE-017 (pembrolizumab) it made PD-1 pathway blockade the first-line standard for advanced disease.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02155647","url":"https://clinicaltrials.gov/study/NCT02155647"},{"label":"Lancet Oncology 2016","url":"https://doi.org/10.1016/S1470-2045(16)30364-3"}],"tags":[],"related":[],"cancers":["merkel-cell-carcinoma","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1"],"drugs":["avelumab"],"companies":["pfizer"],"institutions":[],"pathways":["oncogenic-viruses"],"terms":["irae"],"trials":["pod1um-201","admec-o"],"people":["howard-kaufman"],"bottlenecks":[],"keyPapers":["paper-javelin-merkel-200-lancet-oncol-2016","paper-javelin-merkel-200-j-immunother-cancer-2018-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02155647","phase":"2","setting":"Metastatic Merkel cell carcinoma: avelumab after chemotherapy (part A) and as first-line treatment (part B)","sponsor":"EMD Serono / Pfizer","result":"Objective response 31.8% after chemotherapy (part A) and 39.7% first line (part B).","started":"2014-07-03","startedType":"actual","yearReported":2016,"enrolled":204,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (part A, after chemotherapy)","primary":true,"unit":"%","arms":[{"name":"Avelumab","n":88,"value":31.8}],"source":"https://doi.org/10.1016/S1470-2045(16)30364-3"},{"endpoint":"Objective response rate (part B, first line)","unit":"%","arms":[{"name":"Avelumab","n":116,"value":39.7}],"source":"https://doi.org/10.1136/jitc-2021-002646"}],"replication":"KEYNOTE-017 (pembrolizumab) and the retifanlimab POD1UM-201 study found the same order of response for PD-1 blockade in Merkel cell carcinoma."},{"id":"jbr-10","kind":"trial","name":"JBR.10 (NCIC CTG)","aka":["NCIC CTG JBR.10","JBR10"],"tldr":"Showed that four cycles of cisplatin and vinorelbine after surgery for stage IB or II lung cancer lengthen life, and defined the regimen that became standard.","summary":"JBR.10 randomised 482 patients with completely resected stage IB or II non-small-cell lung cancer and an ECOG performance status of 0 or 1 to vinorelbine plus cisplatin (242 patients) or observation (240). Forty-five percent had stage IB disease and 55 percent stage II; the median age was 61 and 53 percent had adenocarcinoma.\n\nAdjuvant chemotherapy prolonged both disease-free and overall survival. The cost was real: neutropenia in 88 percent, including grade 3 febrile neutropenia in 7 percent, two deaths from toxic effects (0.8 percent), fatigue in 81 percent, nausea in 80 percent, anorexia in 55 percent and neuropathy in 48 percent, though severe non-haematological effects were uncommon.\n\nJBR.10 is why cisplatin with vinorelbine, rather than cisplatin with etoposide, became the adjuvant backbone, and its long-term follow-up showed the benefit was confined to stage II disease, which is why stage IB is now a discussion rather than a recommendation.","status":"positive","asOf":"2026-09-25","links":[{"label":"JBR.10 (New England Journal of Medicine 2005)","url":"https://doi.org/10.1056/NEJMoa043623"}],"tags":[],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["vinorelbine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["ialt","anita","lace-pooled-analysis"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Completely resected stage IB or II non-small-cell lung cancer: four cycles of vinorelbine with cisplatin versus observation, with overall survival as the primary endpoint","sponsor":"National Cancer Institute of Canada Clinical Trials Group","result":"Adjuvant vinorelbine and cisplatin prolonged disease-free and overall survival in completely resected stage IB to II disease; grade 3-4 neutropenia in 88 percent.","yearReported":2005,"enrolled":482,"enrolledBasis":"randomised","enrolledNote":"482 patients were randomised; the trial predates routine registry reporting, so there is no ClinicalTrials.gov enrolment figure quoted here.","outcomes":[],"replication":"ANITA reproduced the result in stage IB to IIIA disease; the LACE pooled analysis confirmed a 5.4 percent absolute five-year survival benefit overall."},{"id":"jcog0403","kind":"trial","name":"JCOG0403","aka":[],"tldr":"JCOG0403 gave the first prospective evidence that stereotactic lung radiotherapy works in patients who could have had surgery, not only in those too frail for it, and set the 48 Gy in four fractions schedule used across Japan.","summary":"JCOG0403 was a two-cohort phase 2 trial of stereotactic body radiotherapy (48 Gy in four fractions) for stage IA non-small-cell lung cancer, enrolling 65 operable and 104 inoperable patients. Three-year overall survival was 76.5 percent in the operable cohort and 59.9 percent in the inoperable one, with acceptable toxicity (Nagata and colleagues, International Journal of Radiation Oncology Biology Physics 2015). It prompted the randomised comparisons of surgery and stereotactic radiotherapy that followed.","status":"positive","asOf":"2026-09-16","links":[{"label":"IJROBP 2015","url":"https://doi.org/10.1016/j.ijrobp.2015.07.2278"}],"tags":["radiation-wave2"],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":["jcog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nagata-int-j-radiat-oncol-biol-phys"],"journals":[],"dependsOn":[],"notes":[],"phase":"2","setting":"Stage IA non-small-cell lung cancer, operable and inoperable patients: stereotactic body radiotherapy 48 Gy in four fractions","sponsor":"Japan Clinical Oncology Group","result":"3-year overall survival 76.5% (operable) and 59.9% (inoperable) after 48 Gy in 4 fractions.","yearReported":2015,"enrolled":169,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Operable patients, SBRT 48 Gy in 4 fractions","n":64,"value":76.5,"note":"95% CI 64.0-85.1"},{"name":"Inoperable patients, SBRT 48 Gy in 4 fractions","n":100,"value":59.9,"note":"95% CI 49.6-68.8"}],"source":"https://doi.org/10.1016/j.ijrobp.2015.07.2278"}]},{"id":"jcog0802","kind":"trial","name":"JCOG0802 / WJOG4607L","aka":["JCOG0802","WJOG4607L"],"tldr":"The trial that showed taking out one segment of a lung, rather than a whole lobe, is enough for a small peripheral lung cancer, and that the smaller operation leaves people alive longer.","summary":"JCOG0802/WJOG4607L randomised 1,106 patients in Japan with a peripheral non-small-cell lung cancer of 2 cm or less to segmentectomy or lobectomy, with overall survival as the primary endpoint and a non-inferiority design. Segmentectomy not only met non-inferiority but was superior for overall survival, which was the surprise: the smaller operation preserves lung function, and the deaths it prevents are from second primary cancers and other causes rather than from the index tumour.\n\nThe 2024 supplemental analysis in Lancet Respiratory Medicine looked at the 553 patients (50 percent) whose tumours were radiologically pure-solid, the group thought most likely to need the larger operation. After a median 7.3 years, five-year overall survival was 92.4 percent after segmentectomy against 86.1 percent after lobectomy (hazard ratio 0.64, 95 percent confidence interval 0.41 to 0.97, log-rank p=0.033), with 38 deaths against 55.\n\nRead with CALGB 140503, which randomised 697 patients in North America to sublobar resection or lobectomy and found disease-free survival non-inferior, the two trials moved sublobar resection from a compromise for the unfit to a standard option for small peripheral tumours. What they do not answer is which sublobar operation, segmentectomy or wedge, and how wide a margin.","status":"positive","asOf":"2026-09-25","links":[{"label":"JCOG0802/WJOG4607L pure-solid supplemental analysis (Lancet Respiratory Medicine 2024)","url":"https://doi.org/10.1016/S2213-2600(23)00382-X"},{"label":"UMIN Clinical Trials Registry UMIN000002317","url":"https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002809"}],"tags":[],"related":[],"cancers":["resectable-nsclc","lung-adenocarcinoma"],"sections":[],"technologies":["robotic-surgery"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["curative-intent","lobectomy","segmentectomy","minimally-invasive-surgery"],"trials":["calgb-140503"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Peripheral non-small-cell lung cancer 2 cm or smaller with a consolidation-to-tumour ratio above 0.5: segmentectomy versus lobectomy, with overall survival as the primary endpoint and non-inferiority as the design","sponsor":"Japan Clinical Oncology Group and West Japan Oncology Group","result":"Segmentectomy was superior to lobectomy for overall survival; in the pure-solid subgroup five-year overall survival was 92.4 against 86.1 percent (hazard ratio 0.64).","yearReported":2022,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 5 years (radiologically pure-solid subgroup)","unit":"%","arms":[{"name":"Segmentectomy","n":279,"value":92.4},{"name":"Lobectomy","n":274,"value":86.1}],"hr":0.64,"ci":[0.41,0.97],"p":"0.033","source":"https://doi.org/10.1016/S2213-2600(23)00382-X"}],"replication":"CALGB 140503 (Alliance) reached the same conclusion for sublobar resection in a North American population with a disease-free survival endpoint."},{"id":"jcog9801","kind":"trial","name":"JCOG9801","aka":["JCOG9801","VCAP-AMP-VECP versus biweekly CHOP in adult T-cell leukaemia/lymphoma","LSG15"],"tldr":"The only randomised trial ever run exclusively in the virus-driven T-cell leukaemia found an intensive Japanese regimen better than standard chemotherapy, at the cost of much more severe low blood counts.","summary":"Adult T-cell leukaemia/lymphoma is caused by human T-lymphotropic virus type 1, a virus endemic in southwestern Japan, where Hinuma's seroepidemiology found antibodies in 26 per cent of healthy adults, and in a small number of other regions. JCOG9801 is the only randomised controlled trial conducted exclusively in the disease. 118 previously untreated patients with aggressive disease were assigned to six courses of VCAP-AMP-VECP, a Japanese three-part regimen, every four weeks, or to eight courses of CHOP every two weeks. Both arms used granulocyte colony-stimulating factor support and intrathecal prophylaxis.\n\nThe complete response rate was higher with VCAP-AMP-VECP, 40 against 25 per cent (p = 0.020). One-year progression-free survival was 28 against 16 per cent (p = 0.100, two-sided p = 0.200) and three-year overall survival 24 against 13 per cent (p = 0.085, two-sided p = 0.169), so the time-to-event endpoints did not reach significance. Grade 4 neutropenia occurred in 98 against 83 per cent, grade 4 thrombocytopenia in 74 against 17 per cent and grade 3 or 4 infection in 32 against 15 per cent, with three toxic deaths in the intensive arm.\n\nThe trial is quoted as establishing VCAP-AMP-VECP as the Japanese standard, and the survival numbers are the honest reason the field has kept looking: three-year overall survival of 24 per cent is what the best available chemotherapy achieved. Allogeneic transplantation, mogamulizumab and interferon with zidovudine in the leukaemic subtypes are the routes that followed. The disease has no cancer record of its own in OnCo yet; it is attached here to peripheral T-cell lymphoma.","status":"mixed","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT00145002","url":"https://clinicaltrials.gov/study/NCT00145002"},{"label":"Journal of Clinical Oncology 2007","url":"https://doi.org/10.1200/JCO.2007.11.9958"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["peripheral-t-cell-lymphoma","non-hodgkin-lymphoma"],"sections":["chemotherapy"],"technologies":[],"targets":[],"drugs":["vincristine","cyclophosphamide","doxorubicin","prednisone","etoposide","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":["lymphoma-tx-cns-prophylaxis","complete-response","intrathecal-therapy"],"trials":[],"people":[],"bottlenecks":["b-rare-cancers","b-global-access","b-trial-enrolment"],"keyPapers":["paper-jcog9801-vcap-amp-vecp-adult-t-cell-leukaemia-jco-2007"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00145002","phase":"3","setting":"Untreated aggressive adult T-cell leukaemia/lymphoma: six courses of VCAP-AMP-VECP every four weeks against eight courses of CHOP every two weeks","sponsor":"Japan Clinical Oncology Group","result":"Complete response 40 against 25 per cent (p = 0.020) and three-year overall survival 24 against 13 per cent, with grade 4 thrombocytopenia in 74 against 17 per cent.","started":"1998-08","yearReported":2007,"enrolled":118,"enrolledBasis":"analysed","enrolledNote":"The registry lists a target of 130; 118 patients were enrolled and analysed in the Journal of Clinical Oncology report.","outcomes":[{"endpoint":"Complete response rate","primary":true,"unit":"%","arms":[{"name":"VCAP-AMP-VECP","value":40},{"name":"Biweekly CHOP","value":25}],"p":"0.020","source":"https://doi.org/10.1200/JCO.2007.11.9958"},{"endpoint":"Overall survival at 3 years","unit":"%","arms":[{"name":"VCAP-AMP-VECP","value":24},{"name":"Biweekly CHOP","value":13}],"p":"0.085 one-sided, 0.169 two-sided"}],"replication":"Never repeated; no second randomised trial has been run exclusively in this disease."},{"id":"nct07175389","kind":"trial","name":"JDB153 Combined With Serplulimab for Pancreatic Cancer After Standard Treatment Failure","aka":[],"tldr":"A phase 1/2 trial of serplulimab in pancreatic cancer, run by West China Hospital, not yet recruiting.","summary":"JDB153 Combined With Serplulimab for Pancreatic Cancer After Standard Treatment Failure is a phase 1/2, interventional study registered as NCT07175389 by West China Hospital, with a registry enrolment figure of 10 participants, started 2026-09-01 and due to reach its primary completion in 2028-09-01. Interventions recorded: JDB153; Serplulimab. Conditions listed: Refractory Pancreatic Ductal Adenocarcinoma; Refractory Pancreatic Adenocarcinoma. Primary outcome: Incidence of Treatment-Related Adverse Events; Objective Response Rate (ORR). Pancreatic eligibility wording from the registry: \"* 1\\) Histologically or cytologically confirmed diagnosis of locally advanced, unresectable, or metastatic pancreatic cancer; 2) Age 18-75 years, inclusive; no sex restrictions; 3) Life expectancy ≥12 weeks; 4) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; 5) Documented dis\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07175389","url":"https://clinicaltrials.gov/study/NCT07175389"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07175389","phase":"1/2","setting":"A Phase Ib/II Clinical Trial of JDB153 Combined With Serplulimab for the Treatment of Pancreatic Cancer Refractory to Standard Therapy","sponsor":"West China Hospital","started":"2026-09-01","startedType":"estimated","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06595186","kind":"trial","name":"JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)","aka":[],"tldr":"A phase 2 trial of Temozolomide in glioma & glioblastoma, run by JenKem Technology Co., Ltd., now recruiting.","summary":"JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM) is a phase 2 interventional study registered as NCT06595186 by JenKem Technology Co., Ltd., with 25 participants planned, started 2022-10-31 and due to reach its primary completion in 2026-08-16. Interventions recorded: JK-1201I and Temozolomide (TMZ).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06595186","url":"https://clinicaltrials.gov/study/NCT06595186"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06595186","phase":"2","setting":"A Multicenter, Single Arm, Open-label, Dose-escalation Phase 2 Study of JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM) After Surgery and Concomitant Radio-chemotherapy","sponsor":"JenKem Technology Co., Ltd.","started":"2022-10-31","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06581380","kind":"trial","name":"JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of topotecan in lung cancer, run by JenKem Technology Co., Ltd., not yet recruiting.","summary":"JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT06581380 by JenKem Technology Co., Ltd., with a registry enrolment figure of 394 participants, started 2024-09-16 and due to reach its primary completion in 2027-11-16. Interventions recorded: JK-1201I; Topotecan. Conditions listed: Small Cell Lung Cancer. Primary outcome: Overall survival (OS). Lung eligibility wording from the registry: \"Histologically or cytologically documented SCLC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06581380","url":"https://clinicaltrials.gov/study/NCT06581380"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["topotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06581380","phase":"3","setting":"A Multicenter, Randomized, Positive-Controlled, Open-label, Phase 3 Study of JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy","sponsor":"JenKem Technology Co., Ltd.","started":"2024-09-16","startedType":"estimated","enrolled":394,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06586866","kind":"trial","name":"JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by JenKem Technology Co., Ltd., not yet recruiting.","summary":"JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases is a phase 2, interventional study registered as NCT06586866 by JenKem Technology Co., Ltd., with a registry enrolment figure of 25 participants, started 2024-09-26 and due to reach its primary completion in 2026-05-26. Interventions recorded: JK-1201I. Conditions listed: Triple Negative Breast Cancer (TNBC); Brain Metastasases. Triple-negative eligibility wording from the registry: \"Histological or cytological confirmation of triple-negative breast cancer (TNBC)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06586866","url":"https://clinicaltrials.gov/study/NCT06586866"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","brain-metastases"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06586866","phase":"2","setting":"A Multicenter, Single-Arm, Phase 2 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases","sponsor":"JenKem Technology Co., Ltd.","started":"2024-09-26","startedType":"estimated","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06391944","kind":"trial","name":"JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Common Mutations","aka":[],"tldr":"A phase 2 trial of Osimertinib in non-small-cell lung cancer, run by Shanghai JMT-Bio Inc., active and no longer recruiting.","summary":"JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Common Mutations is a phase 2 interventional study registered as NCT06391944 by Shanghai JMT-Bio Inc., with 161 participants enrolled, started 2021-11-21 and due to reach its primary completion in 2023-05-17. Interventions recorded: JMT101 Injection and Osimertinib tablet.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06391944","url":"https://clinicaltrials.gov/study/NCT06391944"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06391944","phase":"2","setting":"A Phase 2, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-Small Cell Lung Cancer With EGFR Common Mutations","sponsor":"Shanghai JMT-Bio Inc.","started":"2021-11-21","startedType":"actual","enrolled":161,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06380348","kind":"trial","name":"JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Chara","aka":[],"tldr":"A phase 3 trial of cisplatin and pemetrexed in lung cancer, run by Shanghai JMT-Bio Inc., not yet recruiting.","summary":"JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations is a phase 3, randomised interventional study registered as NCT06380348 by Shanghai JMT-Bio Inc., with a registry enrolment figure of 398 participants, started 2024-04-26 and due to reach its primary completion in 2027-03-26. Interventions recorded: JMT101 Injection; Osimertinib tablet; Cisplatin injection; Pemetrexed injection. Conditions listed: Local Advanced or Metastatic NSCLC. Primary outcome: Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the IASLC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06380348","url":"https://clinicaltrials.gov/study/NCT06380348"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin","pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06380348","phase":"3","setting":"A Randomized, Open-label, Parallel-controlled Phase 3 Study of Combination JMT101 and Osimertinib Compared With Cisplatin -Pemetrexed in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Shanghai JMT-Bio Inc.","started":"2024-04-26","startedType":"estimated","enrolled":398,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04892173","kind":"trial","name":"JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC","aka":[],"tldr":"A phase 3 trial testing JNJ-90301900 in head and neck squamous cell carcinoma, now recruiting.","summary":"JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC is a phase 3 interventional study registered as NCT04892173, led by Johnson & Johnson Enterprise Innovation, and recruiting on the registry. Official title: A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With Locally Advanced Head & Neck Squamous Cell Carcinoma. Planned enrolment is 500 participants (estimated). The study started in 2021-12-10 and primary completion is expected in 2028-06-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04892173","url":"https://clinicaltrials.gov/study/NCT04892173"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":["jnj-90301900"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04892173","phase":"3","setting":"A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With Locally Advanced Head & Neck Squamous Cell Carcinoma","sponsor":"Johnson & Johnson Enterprise Innovation","started":"2021-12-10","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02468024","kind":"trial","name":"JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer","aka":["STABLE-MATES"],"tldr":"A phase 3 trial in lung cancer, run by University of Texas Southwestern Medical Center, now recruiting.","summary":"JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer is a phase 3, randomised interventional study registered as NCT02468024 by University of Texas Southwestern Medical Center, with a registry enrolment figure of 272 participants, started 2015-07 and due to reach its primary completion in 2028-12. Interventions recorded: Lung Surgery; Radiation therapy. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: overall survival. Lung eligibility wording from the registry: \"3 Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities with a solid component of 50% or greater\". Sites: Australia, Canada, United Kingdom, United States. United Kingdom sites listed: 1. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02468024","url":"https://clinicaltrials.gov/study/NCT02468024"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): The James Cook University Hospital (Middlesbrough)."],"nct":"NCT02468024","phase":"3","setting":"JoLT-Ca A Randomized Phase III Study of Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) in High Risk Patients With Stage I Non-Small Cell Lung Cancer (NSCLC), The STABLE-MATES Trial","sponsor":"University of Texas Southwestern Medical Center","started":"2015-07","startedType":"actual","enrolled":272,"enrolledBasis":"registry","outcomes":[]},{"id":"jrosg-99-1","kind":"trial","name":"JROSG 99-1 (Aoyama): stereotactic radiosurgery with or without whole-brain radiotherapy","aka":["JROSG 99-1","Aoyama trial"],"tldr":"Showed that adding whole-brain radiotherapy to focused radiosurgery for a few brain secondaries does not extend life, though it does halve the chance of new ones appearing.","summary":"Whole-brain radiotherapy after stereotactic radiosurgery had been standard on the reasoning that micrometastases invisible on scans would otherwise grow. JROSG 99-1 randomised 132 patients with one to four brain metastases, each under 3 cm, at 11 Japanese hospitals between October 1999 and December 2003 to whole-brain radiotherapy with radiosurgery (65) or radiosurgery alone (67).\n\nMedian survival was 7.5 months with the combination against 8.0 months with radiosurgery alone, and one-year survival 38.5 against 28.4 percent (p=0.42): no survival difference. Twelve-month brain recurrence was 46.8 percent with whole-brain radiotherapy against 76.4 percent without, so salvage treatment was needed far more often when whole-brain radiotherapy was omitted.\n\nThe trial, with the later Alliance N0574 trial that measured cognition directly, moved practice to radiosurgery alone with close MRI surveillance for patients with a limited number of brain metastases, accepting more salvage in exchange for better cognitive function. For lung cancer specifically, the further change is that several targeted drugs, osimertinib, lorlatinib, alectinib and selpercatinib among them, control brain disease by themselves, so radiotherapy is increasingly deferred. QUARTZ separately showed that whole-brain radiotherapy adds nothing to steroids and supportive care in patients with non-small-cell lung cancer unsuitable for surgery or radiosurgery.","status":"mixed","asOf":"2026-09-25","links":[{"label":"JROSG 99-1 (JAMA 2006)","url":"https://doi.org/10.1001/jama.295.21.2483"},{"label":"UMIN C000000412","url":"https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000496"}],"tags":[],"related":[],"cancers":["nsclc","sclc","lung-cancer","secondary-brain-tumours"],"sections":[],"technologies":["radiosurgery-srs","palliative-radiotherapy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["brain-metastases","palliative-treatment"],"trials":["quartz"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"One to four brain metastases, each under 3 cm: stereotactic radiosurgery with up-front whole-brain radiotherapy versus stereotactic radiosurgery alone, with overall survival as the primary endpoint","sponsor":"Japanese Radiation Oncology Study Group","result":"Median survival 7.5 against 8.0 months (p=0.42); twelve-month brain recurrence 46.8 percent with whole-brain radiotherapy against 76.4 percent without.","yearReported":2006,"enrolled":132,"enrolledBasis":"randomised","enrolledNote":"132 patients were randomised at 11 Japanese hospitals; the trial is registered as UMIN C000000412.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Whole-brain radiotherapy with radiosurgery","n":65,"value":7.5},{"name":"Radiosurgery alone","n":67,"value":8}],"p":"0.42","source":"https://doi.org/10.1001/jama.295.21.2483"},{"endpoint":"Brain tumour recurrence at 12 months","unit":"%","arms":[{"name":"Whole-brain radiotherapy with radiosurgery","n":65,"value":46.8},{"name":"Radiosurgery alone","n":67,"value":76.4}],"source":"https://doi.org/10.1001/jama.295.21.2483"}],"replication":"Alliance N0574 reproduced the absence of a survival difference and showed worse cognitive decline with whole-brain radiotherapy; QUARTZ showed no benefit from whole-brain radiotherapy at all in unfit patients with non-small-cell lung cancer."},{"id":"nct06505837","kind":"trial","name":"JS001sc or JS001 Plus Chemotherapy is Indicated for Relapsed or Metastatic First-Line Non-Squamous Non Small Cell Lung Cancer（NSCLC）","aka":[],"tldr":"A phase 3 trial of pemetrexed and toripalimab in lung cancer, run by Shanghai Junshi Bioscience Co., Ltd., active but no longer recruiting.","summary":"JS001sc or JS001 Plus Chemotherapy is Indicated for Relapsed or Metastatic First-Line Non-Squamous Non Small Cell Lung Cancer（NSCLC） is a phase 3, randomised interventional study registered as NCT06505837 by Shanghai Junshi Bioscience Co., Ltd., with a registry enrolment figure of 395 participants, started 2024-07-11 and due to reach its primary completion in 2026-06-30. Interventions recorded: JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy; JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy. Conditions listed: Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer. Primary outcome: Observed serum Ctrough at Cycle 1; Model-predicted area under the concentration-time curve(AUC) from 0 to 21 days at Cycle 1. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed relapsed or metastatic non-squamous NSCLC\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06505837","url":"https://clinicaltrials.gov/study/NCT06505837"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["pemetrexed","toripalimab"],"companies":["junshi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06505837","phase":"3","setting":"Open-Label, Randomized, Phase III Clinical Study Comparing the Pharmacokinetic Profile, Efficacy, and Safety of JS001sc and JS001 in Combination With Standard Chemotherapy as First-Line Treatment for Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer","sponsor":"Shanghai Junshi Bioscience Co., Ltd.","started":"2024-07-11","startedType":"actual","enrolled":395,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06940401","kind":"trial","name":"JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations","aka":[],"tldr":"A phase 1/2 trial of JS111 capsules (AP-L1898) in non-small-cell lung cancer, run by Suzhou Junjing BioSciences Co., Ltd., active and no longer recruiting.","summary":"JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations is a phase 1/2 interventional study registered as NCT06940401 by Suzhou Junjing BioSciences Co., Ltd., with 44 participants enrolled, started 2025-04-30 and due to reach its primary completion in 2028-07-30. Interventions recorded: JS111 capsules (AP-L1898).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06940401","url":"https://clinicaltrials.gov/study/NCT06940401"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":["egfr"],"drugs":["js111"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06940401","phase":"1/2","setting":"A Phase I/II Clinical Study to Evaluate JS111 Capsules in Patients With Locally Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Mutations.","sponsor":"Suzhou Junjing BioSciences Co., Ltd.","started":"2025-04-30","startedType":"actual","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07045311","kind":"trial","name":"JS207 Combination Therapy in Triple-negative Breast Cancer","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Shanghai Junshi Bioscience Co., Ltd., now recruiting.","summary":"JS207 Combination Therapy in Triple-negative Breast Cancer is a phase 2, interventional study registered as NCT07045311 by Shanghai Junshi Bioscience Co., Ltd., with a registry enrolment figure of 80 participants, started 2025-09-17 and due to reach its primary completion in 2028-03-22. Interventions recorded: JS207 in combination with 9MW2821; JS207 in combination with Albumin paclitaxel. Conditions listed: Triple-negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Histologically confirmed unresectable, locally advanced or metastatic triple-negative breast cancer(absence of HER2, ER, and PR expression);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07045311","url":"https://clinicaltrials.gov/study/NCT07045311"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["junshi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07045311","phase":"2","setting":"JS207 Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)","sponsor":"Shanghai Junshi Bioscience Co., Ltd.","started":"2025-09-17","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07503756","kind":"trial","name":"JS212 Combination Therapies in Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of capecitabine, bevacizumab (glioblastoma use) and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Shanghai Junshi Bioscience Co., Ltd., now recruiting.","summary":"JS212 Combination Therapies in Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT07503756 by Shanghai Junshi Bioscience Co., Ltd., with a registry enrolment figure of 80 participants, started 2026-04-25 and due to reach its primary completion in 2027-12-30. Interventions recorded: JS212; Capecitabine; Bevacizumab; Oxaliplatin; JS207. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Investigator-assessed objective response rate (ORR); Safety and Tolerability(AEs); Safety and Tolerability(SAEs). Colorectal eligibility wording from the registry: \"* Adults aged 18-75 years with histologically confirmed metastatic colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07503756","url":"https://clinicaltrials.gov/study/NCT07503756"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["capecitabine","bevacizumab-glioma","folfox"],"companies":["junshi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07503756","phase":"2","setting":"An Open-label, Multicenter Phase 2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JS212 Combination Therapies in Patients With Metastatic Colorectal Cancer","sponsor":"Shanghai Junshi Bioscience Co., Ltd.","started":"2026-04-25","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07384377","kind":"trial","name":"JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Iri","aka":[],"tldr":"A phase 3 trial of JSKN003 in colorectal cancer, run by Shanghai JMT-Bio Inc., not yet recruiting.","summary":"JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan is a phase 3, randomised interventional study registered as NCT07384377 by Shanghai JMT-Bio Inc., with a registry enrolment figure of 123 participants, started 2026-02-06 and due to reach its primary completion in 2027-11-30. Interventions recorded: JSKN003; Physician choiced treatment, include: TAS-102, Regorafenib, Fruquintinib.. Conditions listed: HER2-positive Colorectal Cancer. Primary outcome: Progressive Free Survive (PFS) assessed by Independent Review Committee. Colorectal eligibility wording from the registry: \"* Unresectable locally advanced or distant metastatic BRAFV600E wild-type colorectal cancer diagnosed histologically or cytologically\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07384377","url":"https://clinicaltrials.gov/study/NCT07384377"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","her2-amplified-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["jskn003"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07384377","phase":"3","setting":"A Phase III Trial to Evaluate the Efficacy and Safety of JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan","sponsor":"Shanghai JMT-Bio Inc.","started":"2026-02-06","startedType":"estimated","enrolled":123,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06846437","kind":"trial","name":"JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer","aka":[],"tldr":"A phase 3 trial testing JSKN003 in HER2-positive breast cancer, now recruiting.","summary":"JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer is a phase 3 interventional study registered as NCT06846437, led by Shanghai JMT-Bio, and recruiting on the registry. Official title: A Randomised, Controlled, Open-Label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer Subjects. Planned enrolment is 228 participants (estimated). The study started in 2025-02-18 and primary completion is expected in 2026-10-13. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06846437","url":"https://clinicaltrials.gov/study/NCT06846437"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["jskn003"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06846437","phase":"3","setting":"A Randomized, Controlled, Open-Label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer Subjects","sponsor":"Shanghai JMT-Bio","started":"2025-02-18","startedType":"actual","enrolled":228,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06079983","kind":"trial","name":"JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects","aka":[],"tldr":"A phase 3 trial testing JSKN003 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects is a phase 3 interventional study registered as NCT06079983, led by Jiangsu Alphamab Biopharmaceuticals, and recruiting on the registry. Official title: A Phase 3, Multicenter, Randomised, Open-Label, Active-Controlled Trial Of JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects. Planned enrolment is 400 participants (estimated). The study started in 2023-12-01 and primary completion is expected in 2026-04-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06079983","url":"https://clinicaltrials.gov/study/NCT06079983"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","her2-low-metastatic-breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["jskn003"],"companies":["alphamab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06079983","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial Of JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects","sponsor":"Jiangsu Alphamab Biopharmaceuticals","started":"2023-12-01","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"juliet","kind":"trial","name":"JULIET","aka":["CTL019 in diffuse large B-cell lymphoma","JULIET trial"],"tldr":"The pivotal study of the second CAR-T cell product approved for adult lymphoma, which put about a third of people with no remaining options into a lasting remission.","summary":"JULIET was the international single-arm registration study of tisagenlecleucel, an autologous CD19-directed chimeric antigen receptor T-cell product, in adults with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of therapy or after a failed autologous transplant. It ran in parallel with ZUMA-1 and used a cryopreserved apheresis product and a centralised manufacturing network, which is why its logistics, not only its biology, were studied.\n\nThe trial is in the corpus as its publication (paper-juliet-tisagenlecleucel-dlbcl-nejm-2019); the record here exists so the registry id and the study's place in the sequence have a page. Its practical importance is that it, ZUMA-1 and TRANSCEND NHL 001 together converted CAR-T from an experiment into a third line of treatment, and that the differences between their eligibility rules, bridging policies and manufacturing times explain much of the difference between their headline numbers. JULIET allowed bridging therapy and cryopreserved product; ZUMA-1 did not allow bridging.\n\nThe later randomised second-line trials split on exactly this axis. BELINDA, which tested tisagenlecleucel against salvage chemotherapy and transplant, was negative; ZUMA-7 and TRANSFORM, testing the other two products, were positive.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT02445248","url":"https://clinicaltrials.gov/study/NCT02445248"},{"label":"New England Journal of Medicine 2019","url":"https://doi.org/10.1056/NEJMoa1804980"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["dlbcl","non-hodgkin-lymphoma"],"sections":["cell-therapy"],"technologies":["car-t"],"targets":["cd19"],"drugs":["tisagenlecleucel"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":["crs","icans","bridging-therapy","lymphodepletion","lymphoma-tx-car-t-pathway"],"trials":["zuma-1","belinda","transform","zuma-7"],"people":["stephen-schuster"],"bottlenecks":["b-manufacturing-cell-therapy","b-global-access"],"keyPapers":["paper-juliet-tisagenlecleucel-dlbcl-nejm-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02445248","phase":"2","setting":"Relapsed or refractory diffuse large B-cell lymphoma after two or more lines, or after an autologous transplant: a single infusion of tisagenlecleucel","sponsor":"Novartis Pharmaceuticals","result":"A pivotal single-arm study supporting the approval of tisagenlecleucel in relapsed or refractory large B-cell lymphoma after two or more lines.","started":"2015-07-29","startedType":"actual","yearReported":2019,"enrolled":115,"enrolledBasis":"registry","outcomes":[],"replication":"Followed by the randomised second-line BELINDA trial, which did not show superiority over salvage chemotherapy and transplant."},{"id":"jupiter-02","kind":"trial","name":"JUPITER-02","aka":[],"tldr":"Brought immunotherapy to nasopharyngeal cancer, an Epstein-Barr-virus-driven cancer common in southern China, and won the first US approval for that disease.","summary":"JUPITER-02, trial NCT03581786 sponsored by Junshi and Coherus and reported in 2021, brought immunotherapy to nasopharyngeal carcinoma, an Epstein-Barr-virus-driven cancer common in southern China, and won the first US approval for that disease. It randomised 289 patients with untreated recurrent or metastatic disease to toripalimab or placebo with gemcitabine and cisplatin, met its primary progression-free survival endpoint with a large effect, and confirmed an overall survival benefit with six-year follow-up showing sustained separation, leading to FDA approval on 27 October 2023 and EU approval after. OnCo links it to head and neck cancer, PD-1 as a target, toripalimab, Sun Yat-sen University Cancer Center, Jun Ma and Shanghai Junshi Biosciences. Whether plasma EBV DNA can guide who needs the immunotherapy is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03581786","url":"https://clinicaltrials.gov/study/NCT03581786"},{"label":"6-year update, OncLive","url":"https://www.onclive.com/view/toripalimab-plus-chemo-maintains-survival-benefit-after-6-years-in-recurrent-metastatic-npc"}],"tags":[],"related":[],"cancers":["head-and-neck","nasopharyngeal","recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["toripalimab"],"companies":["junshi","coherus"],"institutions":["sysucc"],"pathways":[],"terms":[],"trials":["captain-1st"],"people":["ma-jun"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03581786","phase":"3","setting":"Untreated recurrent or metastatic nasopharyngeal carcinoma: toripalimab + gemcitabine-cisplatin vs chemotherapy","sponsor":"Junshi / Coherus","result":"PFS HR 0.52; OS HR 0.63.","started":"2018-10-18","startedType":"actual","yearReported":2021,"enrolled":289,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"arms":[{"name":"Toripalimab + chemotherapy"},{"name":"Chemotherapy"}],"hr":0.52,"source":"https://www.onclive.com/view/toripalimab-plus-chemo-maintains-survival-benefit-after-6-years-in-recurrent-metastatic-npc"}],"replication":"CAPTAIN-1st and RATIONALE-309 independently confirmed PD-1 plus chemotherapy in NPC."},{"id":"jupiter-06","kind":"trial","name":"JUPITER-06","aka":[],"tldr":"The trial that added toripalimab to chemotherapy for oesophageal cancer in China and showed a survival gain regardless of PD-L1 level.","summary":"514 patients. Median overall survival 17.0 versus 11.0 months (hazard ratio 0.58) and progression-free survival 5.7 versus 5.5 months (hazard ratio 0.58) at the interim analysis, with benefit independent of PD-L1 expression; published in Cancer Cell 2022. NMPA approval May 2022. One of five Chinese PD-1 trials (with ESCORT-1st, ORIENT-15, RATIONALE-306 and KEYNOTE-590) that made chemo-immunotherapy the first-line standard in a cancer where China has about half the world's cases.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03829969","url":"https://clinicaltrials.gov/study/NCT03829969"},{"label":"Cancer Cell 2022","url":"https://doi.org/10.1016/j.ccell.2022.02.007"}],"tags":["china"],"related":[],"cancers":["esophageal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab","paclitaxel","cisplatin"],"companies":["junshi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["xu-rui-hua"],"bottlenecks":[],"keyPapers":["paper-wang-cancer-cell"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03829969","phase":"3","setting":"First-line advanced oesophageal squamous cell carcinoma, China: toripalimab or placebo plus paclitaxel and cisplatin","sponsor":"Shanghai Junshi Biosciences","result":"OS 17.0 vs 11.0 months (HR 0.58); PFS HR 0.58.","started":"2019-01-31","startedType":"actual","yearReported":2022,"enrolled":514,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Toripalimab + TP","n":257,"value":17},{"name":"Placebo + TP","n":257,"value":11}],"hr":0.58,"source":"https://doi.org/10.1016/j.ccell.2022.02.007"}]},{"id":"nct07154368","kind":"trial","name":"JYP0322 Versus Platinum Based Doublet Chemotherapy in ROS1 Positive Patients Previously Treated With ROS1-TKIs.","aka":[],"tldr":"A phase 3 trial of pemetrexed in lung cancer, run by Guangzhou JOYO Pharma Co., Ltd, not yet recruiting.","summary":"JYP0322 Versus Platinum Based Doublet Chemotherapy in ROS1 Positive Patients Previously Treated With ROS1-TKIs. is a phase 3, randomised interventional study registered as NCT07154368 by Guangzhou JOYO Pharma Co., Ltd, with a registry enrolment figure of 207 participants, started 2025-09-23 and due to reach its primary completion in 2027-10-31. Interventions recorded: Pemetrexed injection; Cross-over to JYP0322; JYP0322 tablets. Conditions listed: Non Small Cell Lung Cancer. Primary outcome: Progression Free Survival (PFS) by BICR Assessment. Lung eligibility wording from the registry: \"* Subjects with histologically or cytologically documented NSCLC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07154368","url":"https://clinicaltrials.gov/study/NCT07154368"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["ros1-positive-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07154368","phase":"3","setting":"A Randomized, Open-Label, Multicenter, Phase 3 Study Evaluating the Efficacy and Safety of JYP0322 Versus Platinum-Based Chemotherapy in ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients Previously Treated With ROS1-TKI Therapy.","sponsor":"Guangzhou JOYO Pharma Co., Ltd","started":"2025-09-23","startedType":"estimated","enrolled":207,"enrolledBasis":"registry","outcomes":[]},{"id":"karmma-3","kind":"trial","name":"KarMMa-3","aka":[],"tldr":"Ide-cel tripled progression-free time versus standard regimens in heavily pretreated myeloma, but did not clearly extend life after most control patients crossed over.","summary":"KarMMa-3, trial NCT03651128 sponsored by Bristol Myers Squibb and 2seventy and published in the New England Journal of Medicine in 2023, showed that idecabtagene vicleucel tripled progression-free time versus standard regimens in triple-class-exposed myeloma after two to four prior lines, but did not clearly extend life after most control patients crossed over. It randomised 386 patients, met its primary progression-free survival endpoint with a much higher response rate, while unadjusted overall survival was no different and crossover-adjusted analyses favoured ide-cel, leading to approval after two lines in April 2024. OnCo links it to multiple myeloma, idecabtagene vicleucel, Nikhil C. Munshi and the KarMMa-3 paper. Whether ide-cel's smaller effect than cilta-cel in CARTITUDE-4 reflects the product or the population is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03651128","url":"https://clinicaltrials.gov/study/NCT03651128"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["idecabtagene-vicleucel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["nikhil-munshi"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03651128","phase":"3","setting":"Triple-class-exposed myeloma after 2-4 prior lines: ide-cel vs standard regimens","sponsor":"BMS / 2seventy","result":"PFS 13.3 vs 4.4 months, HR 0.49.","started":"2019-04-16","startedType":"actual","yearReported":2023,"enrolled":386,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Ide-cel","n":254,"value":13.3},{"name":"Standard regimens","n":132,"value":4.4}],"hr":0.49,"ci":[0.38,0.65],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2213614"}]},{"id":"katherine","kind":"trial","name":"KATHERINE","aka":[],"tldr":"Switching to an ADC after surgery when pre-surgery treatment left cancer behind halved the risk of recurrence and improved survival.","summary":"KATHERINE, trial NCT01772472 sponsored by Roche and Genentech and reported in 2018, showed that switching to the antibody-drug conjugate trastuzumab emtansine after surgery, when pre-surgery treatment left HER2-positive cancer behind, halved the risk of recurrence and improved survival. It randomised 1,486 women with residual invasive disease after neoadjuvant therapy to fourteen cycles of T-DM1 or trastuzumab, met its primary invasive disease-free survival endpoint with a large effect that held at seven years, and showed an overall survival benefit. It was superseded rather than replicated, since DESTINY-Breast05 showed trastuzumab deruxtecan beats T-DM1 in the same population, and whether any patient still needs T-DM1 is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01772472","url":"https://clinicaltrials.gov/study/NCT01772472"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-emtansine","trastuzumab"],"companies":["nsabp-foundation"],"institutions":[],"pathways":[],"terms":["pcr"],"trials":[],"people":["eleftherios-mamounas","charles-geyer","gunter-von-minckwitz"],"bottlenecks":[],"keyPapers":["paper-katherine-nejm-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01772472","phase":"3","setting":"HER2+ early breast cancer with residual invasive disease after neoadjuvant therapy: T-DM1 vs trastuzumab for 14 cycles","sponsor":"Roche / Genentech","result":"iDFS HR 0.50; OS HR 0.66.","started":"2013-04-03","startedType":"actual","yearReported":2018,"enrolled":1486,"enrolledBasis":"registry","outcomes":[{"endpoint":"3-year invasive disease-free survival","primary":true,"unit":"%","arms":[{"name":"T-DM1","n":743,"value":88.3},{"name":"Trastuzumab","n":743,"value":77}],"hr":0.5,"ci":[0.39,0.64],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1814017"},{"endpoint":"Overall survival (7-year)","unit":"%","arms":[{"name":"T-DM1","value":89.1},{"name":"Trastuzumab","value":84.4}],"hr":0.66,"ci":[0.51,0.87],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2406070"}],"replication":"Superseded rather than replicated: DESTINY-Breast05 showed T-DXd beats T-DM1 in the same population."},{"id":"nct07481058","kind":"trial","name":"KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer","aka":[],"tldr":"A phase 2 trial of KC1036, Toripalimab and Cisplatin in oesophageal cancer, run by Beijing Konruns Pharmaceutical Co., Ltd., now recruiting.","summary":"KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer is a phase 2 interventional study registered as NCT07481058 by Beijing Konruns Pharmaceutical Co., Ltd., with 60 participants planned, started 2025-12-12 and due to reach its primary completion in 2027-12. Interventions recorded: KC1036, Toripalimab, Paclitaxel and Cisplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07481058","url":"https://clinicaltrials.gov/study/NCT07481058"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal","oesophageal-squamous-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["kc1036","toripalimab","cisplatin"],"companies":["beijing-konruns-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07481058","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of KC1036 Combined With PD-1 Antibody and Platinum-based Chemotherapy as First-line Treatment for Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma","sponsor":"Beijing Konruns Pharmaceutical Co., Ltd.","started":"2025-12-12","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"ken-she","kind":"trial","name":"KEN SHE (single-dose HPV vaccine)","aka":[],"tldr":"One shot of HPV vaccine was 97.5% effective against the two most dangerous HPV types, making it realistic to vaccinate the whole world.","summary":"Vaccine efficacy 97.5% against persistent HPV16/18 infection at 18 months (NEJM Evidence 2022), sustained at 36 months. Together with the IARC India cohort and Costa Rica trial data, it underpinned the WHO 2022 recommendation for one- or two-dose schedules, adopted by more than 60 countries by 2025 and roughly doubling the number of girls a fixed vaccine supply can protect.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03675256","url":"https://clinicaltrials.gov/study/NCT03675256"},{"label":"Single-dose evidence, Lancet Global Health 2024","url":"https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(24)00009-3/fulltext"}],"tags":[],"related":[],"cancers":["cervical","head-and-neck"],"sections":[],"technologies":["hpv-vaccine"],"targets":[],"drugs":["gardasil-9"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ian-frazer"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03675256","phase":"4","setting":"Kenyan women aged 15-20: single dose of bivalent or nonavalent HPV vaccine vs meningococcal control, endpoint persistent HPV16/18 infection","sponsor":"University of Washington / Bill & Melinda Gates Foundation","result":"Single-dose efficacy 97.5% against persistent HPV16/18.","started":"2018-12-19","startedType":"actual","yearReported":2022,"enrolled":2275,"enrolledBasis":"registry","outcomes":[{"endpoint":"Vaccine efficacy against persistent HPV16/18 infection","primary":true,"unit":"%","arms":[{"name":"Single dose nonavalent HPV","value":97.5}],"source":"https://www.cdc.gov/acip/downloads/slides-2025-04-15-16/03-Barnabas-HPV-508.pdf"}],"replication":"IARC India cohort (Basu 2021) and Costa Rica ESCUDDO/CVT data show similar single-dose protection."},{"id":"kerala-oral-screening","kind":"trial","name":"Kerala oral cancer visual screening trial (Trivandrum)","aka":[],"tldr":"Trained health workers looking inside the mouths of tobacco and alcohol users in Kerala cut oral cancer deaths by a third, and by four-fifths in those who came to every screening round.","summary":"96,517 people in seven intervention clusters and 95,356 in six control clusters were enrolled. After three rounds there were 77 oral cancer deaths in the intervention arm versus 87 in controls (mortality rate ratio 0.79; 95% CI 0.51-1.22 overall), with a significant reduction among tobacco or alcohol users (0.66; 95% CI 0.45-0.95), and 0.57 in male users. At 15 years, after four rounds, oral cancer mortality was 24% lower in tobacco or alcohol users in the intervention arm (95% CI 3-40%) and 81% lower (69-89%) in users who attended all four rounds, with a 38% fall in incidence in that group. It remains the only randomised evidence that oral cancer screening saves lives and underpins India's national screening programme for oral cancer.","status":"positive","asOf":"2026-09-10","links":[{"label":"Sankaranarayanan et al., Lancet 2005","url":"https://doi.org/10.1016/S0140-6736(05)66658-5"},{"label":"15-year follow-up, Oral Oncology 2013","url":"https://doi.org/10.1016/j.oraloncology.2012.11.004"}],"tags":[],"related":[],"cancers":["head-and-neck","oral-cavity-cancer","buccal-mucosa-cancer"],"sections":[],"technologies":["chemoprevention","global-oncology-access","oral-visual-screening"],"targets":[],"drugs":[],"companies":[],"institutions":["iarc"],"pathways":[],"terms":[],"trials":[],"people":["sankaranarayanan-rengaswamy"],"bottlenecks":["b-early-detection","b-prevention-adoption"],"keyPapers":["paper-sankaranarayanan-oral-screening-lancet-2005"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Cluster-randomised trial in 13 clusters of Trivandrum district: three (later four) rounds of oral visual inspection by trained health workers vs usual care in adults aged 35 and over","sponsor":"Regional Cancer Centre Trivandrum with IARC","result":"Oral cancer mortality rate ratio 0.66 in tobacco/alcohol users after 3 rounds; 81% reduction in users who attended all 4 rounds at 15 years.","yearReported":2005,"enrolled":191873,"enrolledBasis":"registry","outcomes":[{"endpoint":"Oral cancer mortality, tobacco or alcohol users (rate ratio, 3 rounds)","primary":true,"arms":[{"name":"Visual screening","n":96517,"value":0.66,"note":"Rate ratio vs control; 95% CI 0.45-0.95"}],"source":"https://doi.org/10.1016/S0140-6736(05)66658-5"}]},{"id":"nct04165070","kind":"trial","name":"KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)","aka":["KEYMAKER-U01"],"tldr":"A phase 1/2 trial of Pembrolizumab, Carboplatin, Pemetrexed and Ifinatamab deruxtecan in non-small-cell lung cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A) is a phase 1/2 interventional study registered as NCT04165070 by Merck Sharp & Dohme LLC, with 450 participants planned, started 2019-12-19 and due to reach its primary completion in 2032-02-13. Interventions recorded: Pembrolizumab, Carboplatin, Paclitaxel, Pemetrexed, Vibostolimab and Boserolimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04165070","url":"https://clinicaltrials.gov/study/NCT04165070"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","carboplatin","pemetrexed","ifinatamab-deruxtecan","vibostolimab","boserolimab"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04165070","phase":"1/2","setting":"KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)","sponsor":"Merck Sharp & Dohme LLC","started":"2019-12-19","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07252739","kind":"trial","name":"KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)","aka":["KEYMAKER-U01"],"tldr":"A phase 2 trial of Calderasib, Pembrolizumab, Cetuximab and Sacituzumab tirumotecan in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J) is a phase 2 interventional study registered as NCT07252739 by Merck Sharp & Dohme LLC, with 140 participants planned, started 2025-12-19 and due to reach its primary completion in 2029-11-15. Interventions recorded: MK-1084, Pembrolizumab, Cetuximab, Sacituzumab tirumotecan (sac-TMT) and Rescue medication.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07252739","url":"https://clinicaltrials.gov/study/NCT07252739"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["calderasib","pembrolizumab","cetuximab","sacituzumab-tirumotecan"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07252739","phase":"2","setting":"KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations","sponsor":"Merck Sharp & Dohme LLC","started":"2025-12-19","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07232602","kind":"trial","name":"KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)","aka":["KEYMAKER-U04"],"tldr":"A phase 1/2 trial of Pembrolizumab in bladder & urothelial cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04) is a phase 1/2 interventional study registered as NCT07232602 by Merck Sharp & Dohme LLC, with 55 participants planned, started 2026-02-09 and due to reach its primary completion in 2031-07-08. Interventions recorded: MK-3120, EV, Pembrolizumab and Rescue Medication.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07232602","url":"https://clinicaltrials.gov/study/NCT07232602"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07232602","phase":"1/2","setting":"A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04-Substudy 04D","sponsor":"Merck Sharp & Dohme LLC","started":"2026-02-09","startedType":"actual","enrolled":55,"enrolledBasis":"registry","outcomes":[]},{"id":"keynote-006","kind":"trial","name":"KEYNOTE-006","aka":[],"tldr":"The trial that made PD-1 blockade the first choice over the older CTLA-4 drug, with a third of patients alive at ten years.","summary":"Pembrolizumab improved PFS and OS versus ipilimumab with fewer high-grade side effects. The 10-year analysis (Annals of Oncology 2024) reported OS 34.0% versus 23.6%; patients who completed two years of pembrolizumab had durable remissions off treatment. Established anti-PD-1 monotherapy as a first-line standard and the two-year treatment duration.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01866319","url":"https://clinicaltrials.gov/study/NCT01866319"},{"label":"10-year follow-up, Annals of Oncology 2024","url":"https://www.annalsofoncology.org/article/S0923-7534(24)03910-3/fulltext"}],"tags":[],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","ctla4"],"drugs":["pembrolizumab","ipilimumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["caroline-robert"],"bottlenecks":[],"keyPapers":["paper-keynote-006-pembrolizumab-ipilimumab-melanoma-nejm-2015"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01866319","phase":"3","setting":"Advanced melanoma, ≤1 prior systemic therapy: pembrolizumab (two schedules) vs ipilimumab","sponsor":"Merck","result":"10-year OS 34.0% vs 23.6%.","started":"2013-08-28","startedType":"actual","yearReported":2015,"enrolled":834,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 10 years","unit":"%","arms":[{"name":"Pembrolizumab","value":34},{"name":"Ipilimumab","value":23.6}],"source":"https://www.annalsofoncology.org/article/S0923-7534(24)03910-3/fulltext"}],"replication":"Consistent with CheckMate 066/067 (nivolumab) and long-term KEYNOTE-001 data; PD-1 superiority over ipilimumab is replicated."},{"id":"keynote-010","kind":"trial","name":"KEYNOTE-010","aka":[],"tldr":"The trial that validated PD-L1 staining as a way of choosing who gets immunotherapy, and gave pembrolizumab its first lung cancer approval.","summary":"KEYNOTE-010 enrolled 1,034 patients at 202 academic centres in 24 countries between August 2013 and February 2015, randomising them 1:1:1 to pembrolizumab 2 mg/kg (345), pembrolizumab 10 mg/kg (346) or docetaxel 75 mg/m2 (343) every three weeks. Entry required PD-L1 on at least 1 percent of tumour cells, and both survival endpoints were tested in the whole population and again in patients with PD-L1 on 50 percent or more.\n\nBy 30 September 2015, 521 patients had died. Median overall survival was 10.4 months with pembrolizumab 2 mg/kg, 12.7 months with 10 mg/kg and 8.5 months with docetaxel; the hazard ratios against docetaxel were 0.71 (95 percent confidence interval 0.58 to 0.88, p=0.0008) and 0.61 (0.49 to 0.75) respectively. The effect was larger in the PD-L1-high subgroup, which is the finding that made PD-L1 selection standard.\n\nThe FDA approved pembrolizumab for PD-L1-positive previously treated non-small-cell lung cancer in 2015 and broadened it on this trial. In England NICE TA428 (11 January 2017, updated 12 September 2017) recommends it after at least one chemotherapy, stopped at two years. The two doses performed similarly and the licensed dose became a flat 200 mg.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01905657","url":"https://clinicaltrials.gov/study/NCT01905657"},{"label":"KEYNOTE-010 (Lancet 2016)","url":"https://doi.org/10.1016/S0140-6736(15)01281-7"},{"label":"NICE TA428: pembrolizumab for PD-L1-positive non-small-cell lung cancer after chemotherapy","url":"https://www.nice.org.uk/guidance/ta428"}],"tags":[],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","companion-diagnostic"],"targets":["pd1","pdl1"],"drugs":["pembrolizumab","docetaxel"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["tps","pd-l1-testing","immune-checkpoint"],"trials":["keynote-024-189","checkmate-017","oak"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01905657","phase":"2/3","setting":"Previously treated advanced non-small-cell lung cancer with PD-L1 on at least 1 percent of tumour cells: pembrolizumab 2 mg/kg or 10 mg/kg versus docetaxel 75 mg/m2, all every three weeks, with overall and progression-free survival in the whole population and in the PD-L1 50 percent or more population as co-primary endpoints","sponsor":"Merck Sharp & Dohme","result":"Median overall survival 10.4 months (pembrolizumab 2 mg/kg) and 12.7 months (10 mg/kg) against 8.5 months with docetaxel; hazard ratios 0.71 and 0.61.","started":"2013-08-09","startedType":"actual","yearReported":2016,"enrolled":1034,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab 2 mg/kg","n":345,"value":10.4},{"name":"Docetaxel","n":343,"value":8.5}],"hr":0.71,"ci":[0.58,0.88],"p":"0.0008","source":"https://doi.org/10.1016/S0140-6736(15)01281-7"},{"endpoint":"Overall survival, higher dose","unit":"months","arms":[{"name":"Pembrolizumab 10 mg/kg","n":346,"value":12.7},{"name":"Docetaxel","n":343,"value":8.5}],"hr":0.61,"ci":[0.49,0.75],"source":"https://doi.org/10.1016/S0140-6736(15)01281-7"}],"replication":"CheckMate 017, CheckMate 057 and OAK reproduced the second-line survival benefit with nivolumab and atezolizumab."},{"id":"keynote-017","kind":"trial","name":"KEYNOTE-017 (Cancer Immunotherapy Trials Network 09)","aka":[],"tldr":"KEYNOTE-017 showed that pembrolizumab given as the first treatment shrinks more than half of advanced Merkel cell carcinomas, whether or not the tumour carries the Merkel cell polyomavirus.","summary":"KEYNOTE-017 was a single-arm phase 2 trial of first-line pembrolizumab in advanced Merkel cell carcinoma run by the Cancer Immunotherapy Trials Network. It tested PD-1 blockade before chemotherapy, on the reasoning that chemotherapy responses in this disease are short and immunosuppressive.\n\nThe objective response rate was 56 percent in the first 26 patients (NEJM 2016) and remained 56 percent in the full cohort of 50 (JCO 2019), with responses in both virus-positive and virus-negative tumours and most responses lasting beyond two years. Grade 3 or worse treatment-related events occurred in a minority and were manageable.\n\nPembrolizumab was approved for Merkel cell carcinoma in December 2018. Together with JAVELIN Merkel 200 it moved immunotherapy to the first line and made chemotherapy a fallback for the minority who do not respond.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02267603","url":"https://clinicaltrials.gov/study/NCT02267603"},{"label":"NEJM 2016","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1603702"},{"label":"JCO 2019","url":"https://ascopubs.org/doi/10.1200/JCO.18.01896"}],"tags":[],"related":[],"cancers":["merkel-cell-carcinoma","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":["oncogenic-viruses"],"terms":["irae"],"trials":["pod1um-201","admec-o"],"people":[],"bottlenecks":[],"keyPapers":["paper-keynote-017-n-engl-j-med-2016","paper-keynote-017-j-immunother-cancer-2021-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02267603","phase":"2","setting":"Advanced Merkel cell carcinoma, no prior systemic therapy: pembrolizumab","sponsor":"Cancer Immunotherapy Trials Network / NCI, with Merck","result":"Objective response 56%, durable in most responders; similar in virus-positive and virus-negative tumours.","started":"2014-11-25","startedType":"actual","yearReported":2016,"enrolled":50,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":50,"value":56}],"source":"https://ascopubs.org/doi/10.1200/JCO.18.01896"}],"replication":"JAVELIN Merkel 200 part B (first-line avelumab) found a first-line response rate of the same order."},{"id":"keynote-024-189","kind":"trial","name":"KEYNOTE-024 & KEYNOTE-189","aka":[],"tldr":"The two trials that made immunotherapy, alone or with chemotherapy, the first treatment for most advanced lung cancers.","summary":"KEYNOTE-024 (305 patients, TPS ≥50%): 5-year OS 31.9% vs 16.3% with chemotherapy. KEYNOTE-189 (616 patients): 5-year OS 19.4% vs 11.3%. Together with KEYNOTE-407 (squamous) they define first-line care for driver-negative disease and are the control arms every new agent (ivonescimab, ADC combinations) must beat.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT02142738","url":"https://clinicaltrials.gov/study/NCT02142738"},{"label":"ClinicalTrials.gov NCT02578680","url":"https://clinicaltrials.gov/study/NCT02578680"}],"tags":[],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","pdl1"],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["tps"],"trials":[],"people":["martin-reck"],"bottlenecks":[],"keyPapers":["paper-keynote-024-nejm-2016","paper-keynote-024-189-j-clin-oncol-2021-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02142738","phase":"3","setting":"First-line metastatic NSCLC without EGFR/ALK: pembrolizumab alone (PD-L1 TPS ≥50%, KEYNOTE-024) or pembrolizumab + platinum-pemetrexed (any PD-L1, non-squamous, KEYNOTE-189)","sponsor":"Merck","result":"5-year OS 31.9% vs 16.3% (024); 19.4% vs 11.3% (189).","started":"2014-08-25","startedType":"actual","yearReported":2016,"enrolled":921,"enrolledBasis":"registry","outcomes":[{"endpoint":"KEYNOTE-024: overall survival at 5 years, PD-L1 ≥50%","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":154,"value":31.9},{"name":"Chemotherapy","n":151,"value":16.3}],"hr":0.62,"ci":[0.48,0.81],"source":"https://ascopubs.org/doi/10.1200/JCO.21.00174"},{"endpoint":"KEYNOTE-189: overall survival, non-squamous","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy","n":410,"value":22},{"name":"Placebo + chemotherapy","n":206,"value":10.6}],"hr":0.6,"ci":[0.5,0.72],"source":"https://ascopubs.org/doi/10.1200/JCO.22.00975"}],"replication":"Replicated by KEYNOTE-042 (PD-L1 ≥1%), KEYNOTE-407 (squamous), IMpower150, and CheckMate 227/9LA; the most replicated result in lung immunotherapy."},{"id":"keynote-042","kind":"trial","name":"KEYNOTE-042","aka":[],"tldr":"KEYNOTE-042 extended pembrolizumab alone to any lung cancer with at least 1 percent PD-L1, but the survival gain came almost entirely from the tumours with 50 percent or more, so chemotherapy is still added for the rest.","summary":"KEYNOTE-042 randomised 1,274 patients with untreated advanced non-small-cell lung cancer, no EGFR or ALK alteration and a PD-L1 tumour proportion score of at least 1 percent to pembrolizumab alone or to platinum-based chemotherapy. It asked whether the KEYNOTE-024 result in PD-L1-high disease extended down to lower expression.\n\nOverall survival favoured pembrolizumab in every prespecified group: median 20.0 versus 12.2 months in tumours with a score of 50 percent or more (hazard ratio 0.69), and 16.7 versus 12.1 months in the whole population with 1 percent or more (hazard ratio 0.81). In the exploratory group with scores of 1 to 49 percent, however, survival was no different (13.4 versus 12.1 months, hazard ratio 0.92).\n\nThe FDA widened the first-line monotherapy label to PD-L1 of 1 percent or more in April 2019, but guidelines reserve monotherapy for scores of 50 percent or more and pair pembrolizumab with chemotherapy below that, following KEYNOTE-189 and KEYNOTE-407.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02220894","url":"https://clinicaltrials.gov/study/NCT02220894"},{"label":"The Lancet 2019","url":"https://doi.org/10.1016/S0140-6736(18)32409-7"}],"tags":[],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","pdl1"],"drugs":["pembrolizumab","carboplatin","paclitaxel","pemetrexed"],"companies":["merck"],"institutions":[],"pathways":["pd1-checkpoint"],"terms":["tps","pd-l1-testing"],"trials":[],"people":["tony-mok"],"bottlenecks":[],"keyPapers":["paper-keynote-042-lancet-2019","paper-keynote-042-j-clin-oncol-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02220894","phase":"3","setting":"Untreated advanced non-small-cell lung cancer without EGFR or ALK alterations and PD-L1 tumour proportion score of 1 percent or more: pembrolizumab versus platinum doublet chemotherapy","sponsor":"Merck","result":"Median overall survival 20.0 vs 12.2 months (PD-L1 50% or more, hazard ratio 0.69); 16.7 vs 12.1 months (1% or more, hazard ratio 0.81); no difference at 1 to 49%.","started":"2014-10-30","startedType":"actual","yearReported":2019,"enrolled":1274,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, PD-L1 tumour proportion score 50% or more","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab","n":299,"value":20},{"name":"Platinum chemotherapy","n":300,"value":12.2}],"hr":0.69,"source":"https://doi.org/10.1016/S0140-6736(18)32409-7"},{"endpoint":"Overall survival, PD-L1 tumour proportion score 1% or more","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab","n":637,"value":16.7},{"name":"Platinum chemotherapy","n":637,"value":12.1}],"hr":0.81,"source":"https://doi.org/10.1016/S0140-6736(18)32409-7"}],"replication":"Consistent with KEYNOTE-024 in the PD-L1-high group; IMpower110 (atezolizumab) and EMPOWER-Lung 1 (cemiplimab) showed the same pattern of benefit concentrated in high expressers."},{"id":"keynote-048","kind":"trial","name":"KEYNOTE-048","aka":[],"tldr":"Made immunotherapy the first treatment for advanced head and neck cancer, alone for PD-L1-rich tumours and with chemotherapy for the rest.","summary":"Pembrolizumab monotherapy improved OS in CPS ≥20 (14.9 vs 10.7 months) and CPS ≥1 (12.3 vs 10.3); pembrolizumab-chemotherapy improved OS in the total population (13.0 vs 10.7). FDA approval June 2019. Five-year follow-up confirmed durable survival tails. Replaced the EXTREME regimen as first line after a decade.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02358031","url":"https://clinicaltrials.gov/study/NCT02358031"},{"label":"Lancet 2019","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32591-7/fulltext"}],"tags":[],"related":[],"cancers":["head-and-neck","oropharyngeal-cancer","laryngeal-cancer","oral-cavity-cancer","recurrent-metastatic-hnscc","hypopharyngeal-cancer","hpv-negative-head-and-neck-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","pdl1"],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["cps"],"trials":["extreme"],"people":["barbara-burtness"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02358031","phase":"3","setting":"Untreated recurrent or metastatic HNSCC: pembrolizumab alone, pembrolizumab + platinum/5-FU, or cetuximab + platinum/5-FU (EXTREME)","sponsor":"Merck","result":"OS 14.9 vs 10.7 months (CPS ≥20, monotherapy); 13.0 vs 10.7 (all, with chemotherapy).","started":"2015-03-19","startedType":"actual","yearReported":2019,"enrolled":882,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, CPS ≥20, pembrolizumab monotherapy","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab","value":14.9},{"name":"Cetuximab + chemotherapy","value":10.7}],"hr":0.61,"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32591-7/fulltext"},{"endpoint":"Overall survival, total population, pembrolizumab + chemotherapy","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy","value":13},{"name":"Cetuximab + chemotherapy","value":10.7}],"hr":0.77,"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32591-7/fulltext"}],"replication":"CheckMate 141 (nivolumab, second line) showed the same direction; KEYNOTE-040 was borderline. Class effect of PD-1 blockade in HNSCC is consistent."},{"id":"keynote-057","kind":"trial","name":"KEYNOTE-057","aka":[],"tldr":"KEYNOTE-057 showed that pembrolizumab could clear bladder cancer confined to the lining in a substantial minority of people whose disease had stopped responding to BCG, giving the first drug alternative to removing the bladder.","summary":"After BCG fails in high-risk non-muscle-invasive bladder cancer the standard is radical cystectomy, which many patients decline or cannot have. KEYNOTE-057 was a single-arm phase 2 study of pembrolizumab in BCG-unresponsive disease. Cohort A enrolled patients with carcinoma in situ with or without papillary tumours, with complete response rate as the primary endpoint; cohort B enrolled papillary-only high-grade disease, with disease-free survival as the endpoint.\n\nIn cohort A a substantial minority achieved a complete response at three months and about half of those responses lasted a year or more, with a systemic immunotherapy toxicity profile. Pembrolizumab was approved in the United States in January 2020 for BCG-unresponsive carcinoma in situ, the first systemic drug for this setting, followed by nadofaragene firadenovec and nogapendekin alfa inbakicept as bladder-sparing alternatives.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02625961","url":"https://clinicaltrials.gov/study/NCT02625961"}],"tags":["subtype-trials"],"related":[],"cancers":["non-muscle-invasive-bladder-cancer","urothelial"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["arjun-balar"],"bottlenecks":[],"keyPapers":["paper-keynote-057-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02625961","phase":"2","setting":"High-risk non-muscle-invasive bladder cancer unresponsive to BCG in patients who decline or are unfit for cystectomy: single-arm pembrolizumab, with cohort A for carcinoma in situ and cohort B for papillary-only disease","sponsor":"Merck & Co. (MSD)","result":"Pembrolizumab produced complete responses in a substantial minority of patients with BCG-unresponsive carcinoma in situ, about half of them lasting a year or more; approved in January 2020.","started":"2016-02-10","startedType":"actual","yearReported":2020,"enrolled":296,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response at 3 months, cohort A (BCG-unresponsive carcinoma in situ)","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":96,"value":41,"note":"95% CI 30.7 to 51.1; median follow-up 36.4 months"}],"source":"https://doi.org/10.1016/S1470-2045(21)00147-9"},{"endpoint":"Grade 3-4 treatment-related adverse events","unit":"%","arms":[{"name":"Pembrolizumab","n":101,"value":13}],"source":"https://doi.org/10.1016/S1470-2045(21)00147-9"}]},{"id":"keynote-062","kind":"trial","name":"KEYNOTE-062","aka":[],"tldr":"KEYNOTE-062 found that pembrolizumab on its own was no worse than chemotherapy for survival in PD-L1-positive stomach cancer, but adding it to chemotherapy did not clearly beat chemotherapy alone; the tumours with the most PD-L1, and those with mismatch-repair deficiency, gained the most.","summary":"KEYNOTE-062 randomised 763 patients with untreated advanced gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1 (combined positive score of 1 or more) to pembrolizumab alone, pembrolizumab plus cisplatin and a fluoropyrimidine, or chemotherapy plus placebo. The primary endpoints were overall and progression-free survival in the PD-L1-positive and high-PD-L1 (score of 10 or more) populations.\n\nPembrolizumab alone was non-inferior to chemotherapy for overall survival, with a larger apparent advantage at a score of 10 or more, but pembrolizumab plus chemotherapy was not superior to chemotherapy alone. Patients with microsatellite-unstable tumours, a small subgroup, did strikingly well with pembrolizumab. The trial did not change first-line practice by itself, but its subgroup findings shaped how later chemo-immunotherapy trials and approvals were read.","status":"mixed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02494583","url":"https://clinicaltrials.gov/study/NCT02494583"}],"tags":["subtype-trials"],"related":[],"cancers":["gastric-pdl1-high","gastric-msi-high","gastric"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","cisplatin","fluorouracil","capecitabine"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["shitara-kohei"],"bottlenecks":[],"keyPapers":["paper-keynote-062-shitara-jama-oncol-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02494583","phase":"3","setting":"Untreated PD-L1-positive (combined positive score of 1 or more), HER2-negative advanced gastric or gastro-oesophageal junction adenocarcinoma: pembrolizumab alone, pembrolizumab plus chemotherapy, or chemotherapy","sponsor":"Merck & Co. (MSD)","result":"Pembrolizumab alone was non-inferior to chemotherapy for overall survival in PD-L1-positive disease; pembrolizumab plus chemotherapy was not superior to chemotherapy; large benefit in the microsatellite-unstable subgroup.","started":"2015-07-31","startedType":"actual","yearReported":2020,"enrolled":763,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, PD-L1 CPS >=1 (non-inferiority)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab","n":256,"value":10.6,"note":"99.2% CI; median follow-up 29.4 months"},{"name":"Chemotherapy","n":250,"value":11.1}],"hr":0.91,"ci":[0.69,1.18],"source":"https://doi.org/10.1001/jamaoncol.2020.3370"},{"endpoint":"Overall survival, PD-L1 CPS >=10","unit":"months","arms":[{"name":"Pembrolizumab","value":17.4,"note":"Not statistically tested"},{"name":"Chemotherapy","value":10.8}],"hr":0.69,"ci":[0.49,0.97],"source":"https://doi.org/10.1001/jamaoncol.2020.3370"},{"endpoint":"Overall survival, PD-L1 CPS >=1","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy","n":257,"value":12.5},{"name":"Chemotherapy","n":250,"value":11.1}],"hr":0.85,"ci":[0.7,1.03],"p":"0.05","source":"https://doi.org/10.1001/jamaoncol.2020.3370"},{"endpoint":"Progression-free survival, PD-L1 CPS >=1","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy","n":257,"value":6.9},{"name":"Chemotherapy","n":250,"value":6.4}],"hr":0.84,"ci":[0.7,1.02],"p":"0.04","source":"https://doi.org/10.1001/jamaoncol.2020.3370"}]},{"id":"keynote-091","kind":"trial","name":"KEYNOTE-091 (PEARLS)","aka":["PEARLS","EORTC-1416-LCG","ETOP 8-15"],"tldr":"Adjuvant pembrolizumab after lung cancer surgery delayed recurrence for everyone, but, unexpectedly, not for the group with the most PD-L1 on their tumour.","summary":"KEYNOTE-091, run as PEARLS by the EORTC Lung Cancer Group and the European Thoracic Oncology Platform, recruited 1,177 of 1,955 screened patients from 196 centres in 29 countries between January 2016 and May 2020. Eligible patients had completely resected stage IB (4 cm or more), II or IIIA disease of any histology and any PD-L1 level; adjuvant chemotherapy was to be considered for stage IB and strongly recommended for stage II and IIIA. Randomisation was 1:1, triple-blind, stratified by stage, previous adjuvant chemotherapy, PD-L1 expression and region.\n\nAt the second interim analysis, disease-free survival was significantly longer with pembrolizumab in the overall population, but the co-primary endpoint in the PD-L1 tumour proportion score 50 percent or greater subgroup (168 and 165 patients) was not met. That inversion, the opposite of what PD-L1 predicts in metastatic disease, is the trial's lasting puzzle and has not been explained.\n\nThe FDA approved adjuvant pembrolizumab on 26 January 2023 for stage IB (T2a 4 cm or more), II or IIIA disease after resection and platinum-based chemotherapy, without a PD-L1 requirement. In England NICE TA1037 (5 February 2025) recommends it within its marketing authorisation for resected disease at high risk of recurrence after platinum chemotherapy, subject to the commercial arrangement.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02504372","url":"https://clinicaltrials.gov/study/NCT02504372"},{"label":"PEARLS/KEYNOTE-091 interim analysis (Lancet Oncology 2022)","url":"https://doi.org/10.1016/S1470-2045(22)00518-6"},{"label":"NICE TA1037: pembrolizumab for adjuvant treatment of resected non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1037"}],"tags":[],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":["nct02486718","checkmate-816","keynote-671"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02504372","phase":"3","setting":"Completely resected stage IB (4 cm or more), II or IIIA non-small-cell lung cancer of any histology and any PD-L1 level, after optional adjuvant chemotherapy: pembrolizumab 200 mg every three weeks for up to 18 cycles versus placebo, with dual primary endpoints of disease-free survival in the whole population and in the PD-L1 tumour proportion score 50 percent or greater population","sponsor":"Merck Sharp & Dohme with the European Organisation for Research and Treatment of Cancer and the European Thoracic Oncology Platform","result":"Disease-free survival significantly improved in the overall population; the co-primary endpoint in the PD-L1 50 percent or greater population was not met.","started":"2015-11-06","startedType":"actual","yearReported":2022,"enrolled":1177,"enrolledBasis":"registry","outcomes":[],"replication":"IMpower010 showed the same direction for adjuvant atezolizumab, but there the benefit was concentrated in the PD-L1-positive stage II to IIIA subgroup, the opposite pattern."},{"id":"keynote-119","kind":"trial","name":"KEYNOTE-119","aka":[],"tldr":"KEYNOTE-119 tested pembrolizumab on its own against chemotherapy as second- or third-line treatment for metastatic triple-negative breast cancer. It did not lengthen life, even in tumours with high PD-L1, which is why immunotherapy in this disease is given with chemotherapy or an antibody-drug conjugate and only in the first line.","summary":"KEYNOTE-119 (NCT02555657) randomised 622 patients with centrally confirmed metastatic triple-negative breast cancer, one or two prior systemic treatments and prior anthracycline or taxane, 1 to 1 to pembrolizumab 200 mg every 3 weeks for up to 35 cycles or single-agent chemotherapy of the investigator's choice (capecitabine, eribulin, gemcitabine or vinorelbine). The primary endpoint was overall survival tested hierarchically in CPS 10 or more, CPS 1 or more and all patients. At a median follow-up of 31.4 months median overall survival in CPS 10 or more was 12.7 versus 11.6 months (hazard ratio 0.78, 95 percent confidence interval 0.57 to 1.06, p 0.057), in CPS 1 or more 10.7 versus 10.2 months (0.86, 0.69 to 1.06, p 0.073) and overall 9.9 versus 10.8 months (0.97, 0.82 to 1.15). Grade 3 to 4 treatment-related adverse events were far less common with pembrolizumab (for example neutropenia below 1 versus 10 percent). The trend with rising PD-L1 expression fed the CPS 10 threshold used in KEYNOTE-355, but the trial itself was negative, pembrolizumab has no monotherapy indication in breast cancer, and NICE discontinued its appraisal of pembrolizumab for previously treated metastatic triple-negative disease (GID-TA10295).","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02555657","url":"https://clinicaltrials.gov/study/NCT02555657"},{"label":"Winer et al., Lancet Oncology 2021: pembrolizumab versus investigator-choice chemotherapy for metastatic TNBC (KEYNOTE-119)","url":"https://doi.org/10.1016/S1470-2045(20)30754-3"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["pembrolizumab","capecitabine","eribulin","gemcitabine","vinorelbine"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["cps"],"trials":["keynote-355","ascent"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02555657","phase":"3","setting":"Metastatic triple-negative breast cancer after one or two prior systemic treatments: pembrolizumab monotherapy versus investigator's choice of capecitabine, eribulin, gemcitabine or vinorelbine, 150 centres in 31 countries","sponsor":"Merck Sharp & Dohme","result":"OS in CPS 10 or more 12.7 vs 11.6 months (HR 0.78, p 0.057); CPS 1 or more 10.7 vs 10.2 (HR 0.86); all patients 9.9 vs 10.8 (HR 0.97). Negative.","started":"2015-10-13","startedType":"actual","yearReported":2021,"enrolled":622,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, PD-L1 CPS 10 or more","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab","value":12.7},{"name":"Chemotherapy","value":11.6}],"hr":0.78,"ci":[0.57,1.06],"p":"0.057","source":"https://doi.org/10.1016/S1470-2045(20)30754-3"},{"endpoint":"Overall survival, PD-L1 CPS 1 or more","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab","value":10.7},{"name":"Chemotherapy","value":10.2}],"hr":0.86,"ci":[0.69,1.06],"p":"0.073","source":"https://doi.org/10.1016/S1470-2045(20)30754-3"},{"endpoint":"Overall survival, all patients","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab","n":312,"value":9.9},{"name":"Chemotherapy","n":310,"value":10.8}],"hr":0.97,"ci":[0.82,1.15],"source":"https://doi.org/10.1016/S1470-2045(20)30754-3"}],"replication":"The PD-L1 gradient was confirmed by KEYNOTE-355, where pembrolizumab with chemotherapy improved survival only at CPS 10 or more."},{"id":"keynote-158","kind":"trial","name":"KEYNOTE-158","aka":["KEYNOTE 158"],"tldr":"The basket trial that showed pembrolizumab alone rarely works in bile duct and gallbladder cancer: only 6 of 104 patients responded, though those who did stayed in response for years. It is also the trial behind the tumour-agnostic approvals of pembrolizumab for mismatch-repair-deficient and high mutation-burden cancers, which do apply to gallbladder cancer.","summary":"KEYNOTE-158 (NCT02628067) is Merck's multi-cohort phase 2 of pembrolizumab 200 mg every three weeks in advanced solid tumours. Its biliary adenocarcinoma cohort enrolled 104 patients with incurable gallbladder or bile duct cancer (ampulla of Vater excluded) that had progressed after standard treatment, regardless of PD-L1 status. Objective response by independent central review was 5.8 percent (6 of 104; 95 percent confidence interval 2.1 to 12.1), median duration of response was not reached (range 6.2 to more than 26.6 months), and median overall and progression-free survival were 7.4 and 2.0 months; response was 6.6 percent in PD-L1 expressers and 2.9 percent in non-expressers. Grade 3 to 5 treatment-related adverse events occurred in 13.5 percent with one grade 5 renal failure. The companion KEYNOTE-028 cohort (24 PD-L1-positive patients) responded in 13 percent. The same trial's mismatch-repair-deficient and tumour mutational burden cohorts underpinned the tumour-agnostic FDA approvals of pembrolizumab (2017 and 2020), which are the route to single-agent immunotherapy for the small minority of gallbladder cancers with those features; for the rest, checkpoint blockade works only in combination with gemcitabine and cisplatin (TOPAZ-1, KEYNOTE-966).","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02628067","url":"https://clinicaltrials.gov/study/NCT02628067"},{"label":"Piha-Paul et al., Int J Cancer 2020: pembrolizumab for advanced biliary cancer, KEYNOTE-158 and KEYNOTE-028","url":"https://doi.org/10.1002/ijc.33013"},{"label":"Marabelle et al., pembrolizumab in non-colorectal MSI-H/dMMR cancer, KEYNOTE-158 (JCO 2020)","url":"https://doi.org/10.1200/JCO.19.02105"},{"label":"Keytruda label (openFDA): MSI-H/dMMR efficacy by tumour type","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22KEYTRUDA%22"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer","msi-high-pdac","pancreatic","metastatic-cancer","endometrial","cervical","vulvar"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["tumour-agnostic","basket-umbrella-platform","msi","tmb"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-hu-mismatch-repair-deficiency-pancreatic-adenocarcinoma-ccr-2018","paper-luchini-msi-dmmr-pancreatic-systematic-review-gut-2021","paper-keynote-158-j-clin-oncol-2019","paper-keynote-158-ann-oncol-2022-update"],"journals":[],"dependsOn":[],"notes":["Pancreatic cancer: the non-colorectal MSI-H or dMMR cohort (JCO 2020) enrolled 233 patients with 27 tumour types, pancreatic among the four commonest, with overall response 34.3 percent, median progression-free survival 4.1 months and median overall survival 23.5 months; the Keytruda label's efficacy table gives 4 responses in 22 pancreatic cancers (18 percent; 95 percent confidence interval 5 to 40). This is the evidence behind the tumour-agnostic US approval used for mismatch repair deficient pancreatic cancer; the EU indication and NICE TA914 do not name pancreatic cancer."],"nct":"NCT02628067","phase":"2","setting":"Advanced solid tumours in histology-defined and biomarker-defined cohorts, including previously treated advanced biliary adenocarcinoma of the gallbladder or biliary tree (n=104; ampullary excluded): pembrolizumab 200 mg every 3 weeks, single arm","sponsor":"Merck Sharp & Dohme","result":"Biliary cohort ORR 5.8% (6/104); median OS 7.4 months; median PFS 2.0 months; median duration of response not reached.","started":"2015-12-18","startedType":"actual","yearReported":2020,"enrolled":1609,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate, biliary adenocarcinoma cohort (independent central review)","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":104,"value":5.8,"note":"95% CI 2.1 to 12.1"}],"source":"https://doi.org/10.1002/ijc.33013"},{"endpoint":"Overall survival, biliary cohort","unit":"months","arms":[{"name":"Pembrolizumab","n":104,"value":7.4}],"source":"https://doi.org/10.1002/ijc.33013"},{"endpoint":"Progression-free survival, biliary cohort","unit":"months","arms":[{"name":"Pembrolizumab","n":104,"value":2}],"source":"https://doi.org/10.1002/ijc.33013"},{"endpoint":"Objective response, MSI-H or dMMR pancreatic cancer cohort (label)","unit":"%","arms":[{"name":"Pembrolizumab 200 mg every 3 weeks","n":22,"value":18,"note":"4 of 22; 95% CI 5 to 40; duration of response 8.1 to 24.3 or more months"}],"source":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22KEYTRUDA%22"}]},{"id":"keynote-170","kind":"trial","name":"KEYNOTE-170","aka":[],"tldr":"KEYNOTE-170 showed that a PD-1 antibody works in primary mediastinal B-cell lymphoma, whose cells carry extra copies of the PD-L1 gene: almost half of heavily treated patients responded, which led to the first drug approval specific to this lymphoma.","summary":"KEYNOTE-170 treated 53 patients with relapsed or refractory primary mediastinal large B-cell lymphoma with pembrolizumab 200 mg every three weeks for up to two years. The disease is defined by gains and rearrangements of the 9p24.1 locus that carries PD-L1, PD-L2 and JAK2, the same lesion that makes classical Hodgkin lymphoma so sensitive to PD-1 blockade.\n\nThe objective response rate was 45 percent with 13 percent complete responses, and responses were durable, with the median duration not reached at a median follow-up of over a year. Together with the KEYNOTE-013 cohort this supported FDA accelerated approval in June 2018 for patients who had relapsed after two or more lines, the first approval of any drug specifically for this lymphoma.\n\nCheckMate 436 later combined nivolumab with brentuximab vedotin in the same setting with a higher response rate, and CD19 CAR-T products licensed for large B-cell lymphoma include primary mediastinal disease in their labels.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02576990","url":"https://clinicaltrials.gov/study/NCT02576990"},{"label":"Journal of Clinical Oncology 2019","url":"https://doi.org/10.1200/JCO.19.01389"}],"tags":[],"related":[],"cancers":["primary-mediastinal-b-cell-lymphoma","dlbcl"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","pdl1","jak2"],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02576990","phase":"2","setting":"Relapsed or refractory primary mediastinal large B-cell lymphoma after autologous transplant, or ineligible for it after two or more lines: pembrolizumab monotherapy","sponsor":"Merck","result":"Objective response rate 45%, complete response 13%, in 53 patients with relapsed or refractory disease; FDA accelerated approval June 2018.","started":"2015-12-02","startedType":"actual","yearReported":2019,"enrolled":53,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":53,"value":45}],"source":"https://doi.org/10.1200/JCO.19.01389"},{"endpoint":"Complete response rate","unit":"%","arms":[{"name":"Pembrolizumab","n":53,"value":13}],"source":"https://doi.org/10.1200/JCO.19.01389"}],"replication":"KEYNOTE-013 (21 patients) showed the same response rate; CheckMate 436 (nivolumab plus brentuximab vedotin) reported a 73 percent response rate in the same population."},{"id":"keynote-177","kind":"trial","name":"KEYNOTE-177","aka":[],"tldr":"The trial that made immunotherapy alone, with no chemotherapy, the first treatment for the 5% of bowel cancers with a broken DNA spell-checker. Over half of patients were alive at five years.","summary":"Pembrolizumab doubled median PFS (16.5 vs 8.2 months, HR 0.60) and at 5-year follow-up (Annals of Oncology 2024) median OS was 77.5 months with a 5-year OS of 54.8%, despite 62% of chemotherapy patients crossing over to anti-PD-1 therapy. First-line FDA approval June 2020. ESMO-MCBS grade 4. The comparator arm's crossover means the OS hazard ratio (0.73) understates the benefit.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02563002","url":"https://clinicaltrials.gov/study/NCT02563002"},{"label":"5-year follow-up, Annals of Oncology 2024","url":"https://www.annalsofoncology.org/article/S0923-7534(24)04949-4/fulltext"}],"tags":[],"related":[],"cancers":["colorectal","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["msi"],"trials":["calgb-80405"],"people":["thierry-andre"],"bottlenecks":[],"keyPapers":["paper-le-mmr-deficiency-pd1-nejm-2015","paper-venderbosch-mmr-braf-metastatic-colorectal-pooled-ccr-2014","paper-keynote-177-nejm-2020","paper-keynote-177-lancet-oncol-2022-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02563002","phase":"3","setting":"First-line MSI-H/dMMR metastatic colorectal cancer: pembrolizumab vs investigator-choice chemotherapy","sponsor":"Merck","result":"PFS 16.5 vs 8.2 months (HR 0.60); 5-year OS 54.8%, median OS 77.5 months.","started":"2015-11-30","startedType":"actual","yearReported":2020,"enrolled":307,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab","n":153,"value":16.5},{"name":"Chemotherapy","n":154,"value":8.2}],"hr":0.6,"ci":[0.45,0.8],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2017699"},{"endpoint":"Overall survival (5-year follow-up)","unit":"months","arms":[{"name":"Pembrolizumab","n":153,"value":77.5},{"name":"Chemotherapy","n":154,"value":36.7}],"hr":0.73,"source":"https://www.annalsofoncology.org/article/S0923-7534(24)04949-4/fulltext"}],"replication":"Consistent with CheckMate 8HW (nivolumab ± ipilimumab) and the earlier single-arm KEYNOTE-164/CheckMate 142 cohorts; the class effect in dMMR CRC is replicated across three antibodies."},{"id":"keynote-204","kind":"trial","name":"KEYNOTE-204","aka":[],"tldr":"In KEYNOTE-204, PD-1 blockade beat the CD30 ADC head to head in relapsed Hodgkin lymphoma.","summary":"KEYNOTE-204, trial NCT02684292 sponsored by Merck and published in Lancet Oncology in 2021, showed that PD-1 blockade with pembrolizumab beats the CD30 antibody-drug conjugate brentuximab vedotin head to head in relapsed or refractory classical Hodgkin lymphoma. It randomised 304 patients and met its primary progression-free survival endpoint with a clear advantage, leading to approval in October 2020 for relapse after at least one line in adults and at least two in children. OnCo links it to Hodgkin lymphoma, pembrolizumab and brentuximab vedotin. Whether the two drugs are better used in sequence or in combination, and which should come first, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02684292","url":"https://clinicaltrials.gov/study/NCT02684292"}],"tags":[],"related":[],"cancers":["hodgkin-lymphoma","relapsed-refractory-hodgkin-lymphoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","brentuximab-vedotin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02684292","phase":"3","setting":"Relapsed/refractory classical Hodgkin lymphoma: pembrolizumab vs brentuximab vedotin","sponsor":"Merck","result":"PFS 13.2 vs 8.3 months, HR 0.65.","started":"2016-05-23","startedType":"actual","yearReported":2020,"enrolled":304,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab","n":151,"value":13.2},{"name":"Brentuximab vedotin","n":153,"value":8.3}],"hr":0.65,"ci":[0.48,0.88],"p":"0.0027","source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00005-X/fulltext"}]},{"id":"keynote-355","kind":"trial","name":"KEYNOTE-355","aka":[],"tldr":"Established immunotherapy plus chemotherapy as first-line treatment for metastatic triple-negative breast cancer with PD-L1 expression.","summary":"KEYNOTE-355, trial NCT02819518 sponsored by Merck and published in the New England Journal of Medicine in 2022, established pembrolizumab plus chemotherapy as first-line treatment for metastatic triple-negative breast cancer with PD-L1 expression. It randomised 847 patients and met its primary progression-free and overall survival endpoints in tumours with a combined positive score of ten or more, with no benefit below that threshold, which defined the PD-L1 cut-off used today. OnCo links it to triple-negative breast cancer, pembrolizumab, the CPS term, the TNBC roadmap and IMpassion131. It is now being succeeded by ADC-based first-line regimens such as ASCENT-04, and whether chemotherapy remains part of first-line treatment at all is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT02819518","url":"https://clinicaltrials.gov/study/NCT02819518"},{"label":"KEYNOTE-355 progression-free survival (Lancet 2020)","url":"https://doi.org/10.1016/S0140-6736(20)32531-9"},{"label":"KEYNOTE-355 overall survival (NEJM 2022)","url":"https://doi.org/10.1056/NEJMoa2202809"},{"label":"NICE TA801 (29 June 2022)","url":"https://www.nice.org.uk/guidance/ta801"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["cps"],"trials":["keynote-119","impassion130","ascent-04","tropion-breast05"],"people":[],"bottlenecks":[],"keyPapers":["paper-sigurjonsdottir-sp142-22c3-tnbc-bcr-2023","paper-keynote-355-lancet-2020"],"journals":[],"dependsOn":[],"notes":["Design (Lancet 2020): 847 patients randomised 2 to 1 to pembrolizumab or placebo with nab-paclitaxel, paclitaxel or gemcitabine and carboplatin at 209 sites in 29 countries; the registry figure of 882 includes the 32-patient part 1 safety run-in. Progression-free survival in CPS 10 or more 9.7 versus 5.6 months (hazard ratio 0.65); final overall survival (NEJM 2022) 23.0 versus 16.1 months in CPS 10 or more (hazard ratio 0.73, p 0.0185), 17.6 versus 16.0 in CPS 1 or more (0.86, not significant) and 17.2 versus 15.5 overall (0.89, not tested). Grade 3 to 5 treatment-related adverse events 68.1 versus 66.9 percent.","UK access: NICE TA801 (29 June 2022) limits the regimen to CPS 10 or more with immune-cell staining below 1 percent, because atezolizumab with nab-paclitaxel (TA639) is commissioned for the immune-cell-positive group."],"nct":"NCT02819518","phase":"3","setting":"First-line metastatic TNBC: pembrolizumab + chemotherapy vs chemotherapy","sponsor":"Merck","result":"OS HR 0.73 in CPS ≥10.","started":"2016-07-27","startedType":"actual","yearReported":2020,"enrolled":882,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, PD-L1 CPS ≥10","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy","n":220,"value":23},{"name":"Placebo + chemotherapy","n":103,"value":16.1}],"hr":0.73,"ci":[0.55,0.95],"p":"0.0185","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2202809"},{"endpoint":"Progression-free survival, PD-L1 CPS ≥10","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy","value":9.7},{"name":"Placebo + chemotherapy","value":5.6}],"hr":0.66,"ci":[0.5,0.88],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2202809"},{"endpoint":"Overall survival, CPS ≥1","unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy","value":17.6,"note":"Not significant"},{"name":"Placebo + chemotherapy","value":16}],"hr":0.86,"ci":[0.72,1.04],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2202809"}],"replication":"Consistent direction with IMpassion130 (atezolizumab, PD-L1+); IMpassion131 was negative, so the PD-L1 CPS ≥10 population and the chemotherapy partner matter. Now being superseded by ADC + pembrolizumab (ASCENT-04)."},{"id":"keynote-407","kind":"trial","name":"KEYNOTE-407","aka":[],"tldr":"KEYNOTE-407 showed that adding pembrolizumab to chemotherapy helped people with squamous lung cancer live longer whatever their PD-L1 level, and made chemo-immunotherapy the standard first treatment for this type.","summary":"KEYNOTE-407 randomised 559 patients with untreated metastatic squamous non-small-cell lung cancer to carboplatin and either paclitaxel or nab-paclitaxel with pembrolizumab or with placebo, followed by pembrolizumab or placebo maintenance. Squamous tumours had been left behind by the targeted-therapy era and had no chemotherapy-free option beyond high-PD-L1 pembrolizumab.\n\nBoth primary endpoints, overall survival and progression-free survival, favoured the pembrolizumab arm, and the benefit was seen across PD-L1 expression groups. The combination was approved in the United States in October 2018 and became the first-line standard for squamous disease without a driver mutation.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02775435","url":"https://clinicaltrials.gov/study/NCT02775435"}],"tags":["subtype-trials"],"related":[],"cancers":["pdl1-high-nsclc","nsclc","lung-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","carboplatin","paclitaxel"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["luis-paz-ares"],"bottlenecks":[],"keyPapers":["paper-keynote-407-n-engl-j-med-2018","paper-keynote-407-j-clin-oncol-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02775435","phase":"3","setting":"Untreated metastatic squamous non-small-cell lung cancer: carboplatin with paclitaxel or nab-paclitaxel, with pembrolizumab or placebo","sponsor":"Merck & Co. (MSD)","result":"Pembrolizumab plus carboplatin and a taxane improved overall and progression-free survival over chemotherapy alone across PD-L1 levels; approved in October 2018.","started":"2016-06-09","startedType":"actual","yearReported":2018,"enrolled":559,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel","value":15.9,"note":"Median follow-up 7.8 months; 559 randomised"},{"name":"Placebo + carboplatin + paclitaxel or nab-paclitaxel","value":11.3}],"hr":0.64,"ci":[0.49,0.85],"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1810865"},{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel","value":6.4},{"name":"Placebo + carboplatin + paclitaxel or nab-paclitaxel","value":4.8}],"hr":0.56,"ci":[0.45,0.7],"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1810865"},{"endpoint":"Grade 3 or higher adverse events","unit":"%","arms":[{"name":"Pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel","value":69.8},{"name":"Placebo + carboplatin + paclitaxel or nab-paclitaxel","value":68.2}],"source":"https://doi.org/10.1056/nejmoa1810865"},{"endpoint":"Discontinuation for adverse events","unit":"%","arms":[{"name":"Pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel","value":13.3},{"name":"Placebo + carboplatin + paclitaxel or nab-paclitaxel","value":6.4}],"source":"https://doi.org/10.1056/nejmoa1810865"}]},{"id":"keynote-412","kind":"trial","name":"KEYNOTE-412","aka":[],"tldr":"KEYNOTE-412 tested adding pembrolizumab to standard chemoradiotherapy for locally advanced head and neck cancer; the improvement in keeping patients free of disease fell short of statistical significance, so chemoradiotherapy alone remains the standard.","summary":"KEYNOTE-412 randomised 804 patients with newly diagnosed locally advanced head and neck squamous cell carcinoma (oropharynx, larynx or hypopharynx, and oral cavity) to pembrolizumab or placebo given as a priming dose before, concurrently with and for a year after cisplatin-based chemoradiotherapy. The primary endpoint was event-free survival.\n\nEvent-free survival favoured pembrolizumab but the difference did not reach the prespecified threshold for statistical significance, with a larger effect in PD-L1-high tumours in exploratory analysis. Together with the negative JAVELIN Head and Neck 100 trial of avelumab, it showed that concurrent checkpoint blockade does not reliably add to definitive chemoradiotherapy, in contrast to the success of neoadjuvant and adjuvant pembrolizumab around surgery in KEYNOTE-689.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03040999","url":"https://clinicaltrials.gov/study/NCT03040999"}],"tags":["subtype-trials"],"related":[],"cancers":["hpv-negative-head-and-neck-cancer","head-and-neck"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","cisplatin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jean-pascal-machiels"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03040999","phase":"3","setting":"Locally advanced head and neck squamous cell carcinoma: cisplatin chemoradiotherapy with pembrolizumab or placebo given before, during and after","sponsor":"Merck & Co. (MSD)","result":"Pembrolizumab added to chemoradiotherapy did not significantly improve event-free survival.","started":"2017-04-05","startedType":"actual","yearReported":2022,"enrolled":804,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemoradiotherapy","n":402,"note":"Not reached (95% CI 44.7 months to not reached); median follow-up 47.7 months"},{"name":"Placebo + chemoradiotherapy","n":402,"value":46.6}],"hr":0.83,"ci":[0.68,1.03],"p":"0.043 (significance threshold 0.024)","source":"https://doi.org/10.1016/s1470-2045(24)00100-1"},{"endpoint":"Grade 3 or worse adverse events","unit":"%","arms":[{"name":"Pembrolizumab + chemoradiotherapy","n":398,"value":92},{"name":"Placebo + chemoradiotherapy","n":398,"value":88}],"source":"https://doi.org/10.1016/s1470-2045(24)00100-1"},{"endpoint":"Serious adverse events","unit":"%","arms":[{"name":"Pembrolizumab + chemoradiotherapy","n":398,"value":62},{"name":"Placebo + chemoradiotherapy","n":398,"value":49}],"source":"https://doi.org/10.1016/s1470-2045(24)00100-1"}]},{"id":"keynote-426","kind":"trial","name":"KEYNOTE-426","aka":[],"tldr":"The first immunotherapy plus targeted-pill combination for kidney cancer, improving survival across all risk groups.","summary":"KEYNOTE-426, trial NCT02853331 sponsored by Merck and reported in 2019, produced the first immunotherapy plus targeted tablet combination for kidney cancer, improving survival across all risk groups. It randomised 861 patients with untreated advanced clear-cell renal cell carcinoma to pembrolizumab plus axitinib or sunitinib, met its primary overall and progression-free survival endpoints, and led to FDA approval in April 2019, although the survival advantage attenuated over five years as control patients crossed over to later-line immunotherapy. OnCo links it to renal cell carcinoma, pembrolizumab, axitinib, sunitinib, the IMDC risk group term, Thomas Powles, Brian I. Rini and Jae Lyun Lee. Whether the shrinking long-term difference means the combination mainly brings immunotherapy forward rather than adding to it is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02853331","url":"https://clinicaltrials.gov/study/NCT02853331"}],"tags":[],"related":[],"cancers":["rcc","clear-cell-rcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","axitinib","sunitinib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["thomas-powles","brian-rini","lee-jae-lyun"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02853331","phase":"3","setting":"Untreated advanced clear-cell RCC: pembrolizumab + axitinib vs sunitinib","sponsor":"Merck","result":"OS HR 0.84 final (47.2 vs 40.8 months); PFS HR 0.69.","started":"2016-09-16","startedType":"actual","yearReported":2019,"enrolled":861,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (final, 5-year)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + axitinib","n":432,"value":47.2},{"name":"Sunitinib","n":429,"value":40.8}],"hr":0.84,"ci":[0.71,0.99],"source":"https://ascopubs.org/doi/10.1200/JCO.23.01000"},{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + axitinib","value":15.7},{"name":"Sunitinib","value":11.1}],"hr":0.69,"source":"https://doi.org/10.1056/NEJMoa1816714"}],"replication":"Consistent with JAVELIN Renal 101 (avelumab + axitinib, PFS only), CheckMate 9ER, and CLEAR."},{"id":"keynote-522","kind":"trial","name":"KEYNOTE-522","aka":[],"tldr":"The trial that added immunotherapy to pre-surgery chemotherapy for triple-negative breast cancer and, uniquely, improved survival.","summary":"1,174 patients. pCR 64.8% vs 51.2%; event-free survival at 5 years 81.2% vs 72.2%; 7-year EFS 78.3% vs 69.8% and OS 85.1% vs 77.2% (ASCO 2026 update). Defines the standard of care for stage II-III TNBC. Open questions: whether adjuvant pembrolizumab is needed after pCR (OptimICE-pCR) and how to escalate for residual disease.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT03036488","url":"https://clinicaltrials.gov/study/NCT03036488"},{"label":"KEYNOTE-522 pathological complete response (NEJM 2020)","url":"https://doi.org/10.1056/NEJMoa1910549"},{"label":"KEYNOTE-522 event-free survival (NEJM 2022)","url":"https://doi.org/10.1056/NEJMoa2112651"},{"label":"KEYNOTE-522 overall survival (NEJM 2024)","url":"https://doi.org/10.1056/NEJMoa2409932"},{"label":"KEYNOTE-522 event-free survival by residual cancer burden (Annals of Oncology 2024)","url":"https://doi.org/10.1016/j.annonc.2024.02.002"},{"label":"NICE TA851 (14 December 2022)","url":"https://www.nice.org.uk/guidance/ta851"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","carboplatin","paclitaxel"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["pcr","efs","rcb","tnbc-residual-disease-decision"],"trials":["swog-s1418","optimice-pcr","scarlet-s2212","ascent-05","tropion-breast03"],"people":["rebecca-dent","peter-schmid","loi-sherene"],"bottlenecks":[],"keyPapers":["paper-keynote-522-n-engl-j-med-2020","paper-keynote-522-n-engl-j-med-2024-update"],"journals":[],"dependsOn":[],"notes":["Design (NEJM 2020): 1,174 patients with untreated stage II or III triple-negative breast cancer randomised 2 to 1 to pembrolizumab 200 mg or placebo every 3 weeks with four cycles of paclitaxel and carboplatin then four of doxorubicin or epirubicin with cyclophosphamide, surgery, then nine cycles of adjuvant pembrolizumab or placebo. Pathological complete response 64.8 versus 51.2 percent (first 602 patients); event-free survival at 36 months 84.5 versus 76.8 percent (hazard ratio 0.63, NEJM 2022); overall survival at 60 months 86.6 versus 81.7 percent (p 0.002, median follow-up 75.1 months, NEJM 2024). Residual cancer burden analysis (Annals of Oncology 2024): pembrolizumab reduced events in RCB-0, 1 and 2 (hazard ratios 0.70, 0.92, 0.52) but not RCB-3 (1.24).","UK sites (registry, 7): Colchester General Hospital, Barts Cancer Institute, St George's Hospital London, Maidstone Hospital, James Cook University Hospital Middlesbrough, Nottingham University Hospitals, Royal Cornwall Hospitals Truro. NICE TA851 (14 December 2022) commissions the regimen in England.","Label safety (Keytruda, 778 treated patients): serious adverse reactions 44 percent, fatal 0.9 percent, discontinuation of pembrolizumab 20 percent, most often for raised transaminases and rash."],"nct":"NCT03036488","phase":"3","setting":"Early-stage (II-III) TNBC: pembrolizumab + chemotherapy before surgery, pembrolizumab after","sponsor":"Merck","result":"EFS HR 0.63; OS HR 0.66 (5-year); 7-year OS 85.1% vs 77.2%.","started":"2017-03-07","startedType":"actual","yearReported":2020,"enrolled":1174,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathologic complete response (ypT0/Tis ypN0)","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab + chemotherapy","n":401,"value":64.8},{"name":"Placebo + chemotherapy","n":201,"value":51.2}],"p":"0.00055","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1910549"},{"endpoint":"Event-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab + chemotherapy","n":784,"value":81.2},{"name":"Placebo + chemotherapy","n":390,"value":72.2}],"hr":0.65,"ci":[0.51,0.83],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2409932"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Pembrolizumab + chemotherapy","value":86.6},{"name":"Placebo + chemotherapy","value":81.7}],"hr":0.66,"ci":[0.5,0.87],"p":"0.002","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2409932"},{"endpoint":"Event-free survival at 7 years","unit":"%","arms":[{"name":"Pembrolizumab + chemotherapy","value":78.3},{"name":"Placebo + chemotherapy","value":69.8}],"source":"https://www.lbbc.org/news/pivotal-progress-in-tnbc-asco-2026"},{"endpoint":"Overall survival at 7 years","unit":"%","arms":[{"name":"Pembrolizumab + chemotherapy","value":85.1},{"name":"Placebo + chemotherapy","value":77.2}],"source":"https://www.lbbc.org/news/pivotal-progress-in-tnbc-asco-2026"}],"replication":"Single pivotal trial, but the EFS and OS benefits held through the 5- and 7-year analyses; consistent with IMpassion031 (atezolizumab, pCR only) and with real-world neoadjuvant pembrolizumab series."},{"id":"keynote-564","kind":"trial","name":"KEYNOTE-564","aka":[],"tldr":"The first drug to help kidney cancer patients live longer after surgery, and the first adjuvant immunotherapy in any solid tumour to show an overall survival gain.","summary":"KEYNOTE-564, trial NCT03142334 sponsored by Merck and reported in 2021, produced the first drug to help kidney cancer patients live longer after surgery, and the first adjuvant immunotherapy in any solid tumour to show an overall survival gain. It randomised 994 patients with clear-cell renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy, or with no evidence of disease after metastasectomy, to a year of pembrolizumab or placebo, met its primary disease-free survival endpoint and showed a survival benefit at five years, leading to FDA approval in November 2021. OnCo links it to renal cell carcinoma, pembrolizumab, the perioperative and nephrectomy terms, Toni K. Choueiri and the idea of biomarker-selected adjuvant therapy. Why pembrolizumab succeeded where three other adjuvant immunotherapy trials failed is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03142334","url":"https://clinicaltrials.gov/study/NCT03142334"}],"tags":[],"related":[],"cancers":["rcc","clear-cell-rcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","nephrectomy"],"trials":[],"people":["toni-choueiri"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03142334","phase":"3","setting":"Clear-cell RCC at intermediate-high or high risk of recurrence after nephrectomy (or M1 NED): adjuvant pembrolizumab 1 year vs placebo","sponsor":"Merck","result":"DFS HR 0.72; OS HR 0.62.","started":"2017-06-09","startedType":"actual","yearReported":2021,"enrolled":994,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival","primary":true,"arms":[{"name":"Pembrolizumab","n":496},{"name":"Placebo","n":498}],"hr":0.72,"ci":[0.59,0.87],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2106391"},{"endpoint":"Overall survival (57-month follow-up)","unit":"% alive","arms":[{"name":"Pembrolizumab","value":91.2},{"name":"Placebo","value":86}],"hr":0.62,"ci":[0.44,0.87],"p":"0.002","source":"https://www.targetedonc.com/view/adjuvant-pembrolizumab-offers-improved-os-in-keynote-564-trial-of-ccrcc"}],"replication":"Not replicated by atezolizumab (IMmotion010), nivolumab ± ipilimumab (CheckMate 914), or perioperative nivolumab (PROSPER); LITESPARK-022 (pembrolizumab ± belzutifan) is positive on DFS."},{"id":"keynote-590","kind":"trial","name":"KEYNOTE-590","aka":[],"tldr":"Added immunotherapy to first-line chemotherapy for all types of oesophageal cancer, with a survival benefit that held at five years.","summary":"KEYNOTE-590, trial NCT03189719 sponsored by Merck and reported in 2020, added pembrolizumab to first-line cisplatin and fluorouracil chemotherapy for all types of advanced oesophageal cancer and Siewert type I junction tumours, with a survival benefit that held at five years. It randomised 749 patients and met its primary overall survival endpoint in all patients, with a larger effect in PD-L1 CPS 10 or higher, and the five-year follow-up published in ESMO Open in 2025 confirmed the benefit; the FDA approved it for all patients in March 2021 while the EMA restricted it to CPS 10 or higher. OnCo links it to oesophageal cancer, PD-1 as a target, pembrolizumab, the CPS term and Ken Kato. Benefit in PD-L1-negative disease is uncertain, which is the open question behind the regional label split.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03189719","url":"https://clinicaltrials.gov/study/NCT03189719"}],"tags":[],"related":[],"cancers":["esophageal","oesophageal-squamous-cell-carcinoma","oesophageal-adenocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["cps"],"trials":[],"people":["ken-kato"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03189719","phase":"3","setting":"First-line advanced oesophageal cancer (squamous and adenocarcinoma) and Siewert I GEJ: pembrolizumab + cisplatin/5-FU vs chemotherapy","sponsor":"Merck","result":"OS 12.4 vs 9.8 months (HR 0.73); 5-year OS HR 0.72.","started":"2017-07-25","startedType":"actual","yearReported":2020,"enrolled":749,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, all patients","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy","n":373,"value":12.4},{"name":"Placebo + chemotherapy","n":376,"value":9.8}],"hr":0.73,"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01234-4/abstract"},{"endpoint":"Overall survival at 5-year follow-up","arms":[{"name":"Pembrolizumab + chemotherapy"},{"name":"Placebo + chemotherapy"}],"hr":0.72,"ci":[0.62,0.84],"source":"https://www.esmoopen.com/article/S2059-7029(25)01723-5/fulltext"}],"replication":"Replicated by CheckMate 648, RATIONALE-306, ESCORT-1st, JUPITER-06, and ORIENT-15 in squamous disease."},{"id":"keynote-629","kind":"trial","name":"KEYNOTE-629","aka":[],"tldr":"KEYNOTE-629 showed that pembrolizumab shrinks about a third of recurrent or metastatic skin squamous cell cancers and half of locally advanced ones, giving a second immunotherapy option after cemiplimab.","summary":"KEYNOTE-629 was a single-arm phase 2 trial of pembrolizumab with two cohorts: recurrent or metastatic cutaneous squamous cell carcinoma, and locally advanced disease not curable by surgery or radiotherapy.\n\nIn the recurrent or metastatic cohort of 105 patients the objective response rate was 34 percent (JCO 2020); in the locally advanced cohort of 54 patients it was 50 percent, with responses in both cohorts lasting well beyond a year in most responders. Toxicity matched pembrolizumab in other cancers.\n\nPembrolizumab was approved for recurrent or metastatic cutaneous squamous cell carcinoma in June 2020 and for locally advanced disease in July 2021, making it the second PD-1 antibody available and confirming that the EMPOWER-CSCC-1 result was a class effect.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03284424","url":"https://clinicaltrials.gov/study/NCT03284424"},{"label":"JCO 2020","url":"https://ascopubs.org/doi/10.1200/JCO.19.03054"}],"tags":[],"related":[],"cancers":["advanced-cutaneous-scc","cutaneous-scc","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["radiotherapy-for-skin-cancer"],"trials":["c-post","neoadjuvant-cemiplimab-cscc","ck-301-101"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03284424","phase":"2","setting":"Recurrent or metastatic, and separately locally advanced, cutaneous squamous cell carcinoma: pembrolizumab","sponsor":"Merck","result":"Objective response 34% in recurrent or metastatic disease and 50% in locally advanced disease.","started":"2017-10-26","startedType":"actual","yearReported":2020,"enrolled":159,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (recurrent or metastatic cohort)","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":105,"value":34}],"source":"https://ascopubs.org/doi/10.1200/JCO.19.03054"},{"endpoint":"Objective response rate (locally advanced cohort)","unit":"%","arms":[{"name":"Pembrolizumab","n":54,"value":50}],"source":"https://doi.org/10.1016/j.jaad.2021.04.008"}],"replication":"Consistent with EMPOWER-CSCC-1 (cemiplimab) and the cosibelimab pivotal study."},{"id":"keynote-641","kind":"trial","name":"KEYNOTE-641","aka":["KEYNOTE-641","MK-3475-641"],"tldr":"Adding pembrolizumab to enzalutamide did not help. The trial was stopped for futility, and three times as many men had a serious side effect.","summary":"KEYNOTE-641 randomised 1,244 men with chemotherapy-naive metastatic castration-resistant prostate cancer to pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles, both with enzalutamide 160 mg daily.\n\nAt the data cutoff of 12 December 2022, median follow-up 27.6 months, neither primary endpoint was met. Median overall survival was 24.7 months with pembrolizumab against 27.3 months with placebo, hazard ratio 1.04 (95 percent confidence interval 0.88 to 1.22, p=0.66). Median radiographic progression-free survival was 10.4 against 9.0 months, hazard ratio 0.98 (0.84 to 1.14, p=0.41). The prespecified futility boundary for overall survival was crossed and the study was stopped.\n\nThe toxicity difference is the reason this is a harm and not merely a null result. Grade 3 or higher treatment-related adverse events occurred in 192 of 615 participants (31.2 percent) on pembrolizumab with enzalutamide against 67 of 620 (10.8 percent) on placebo with enzalutamide, and 71 (11.5 percent) against 21 (3.4 percent) discontinued for a treatment-related adverse event.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03834493","url":"https://clinicaltrials.gov/study/NCT03834493"},{"label":"KEYNOTE-641 (Annals of Oncology 2025)","url":"https://doi.org/10.1016/j.annonc.2025.05.007"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","androgen-receptor"],"drugs":["pembrolizumab","enzalutamide"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["castration-resistance","arpi"],"trials":["imbassador250","keynote-921","keynote-991"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03834493","phase":"3","setting":"Chemotherapy-naive metastatic castration-resistant prostate cancer, prior abiraterone permitted and prior docetaxel allowed only in the hormone-sensitive setting: pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles with enzalutamide 160 mg daily, with dual primary endpoints of overall survival and radiographic progression-free survival","sponsor":"Merck Sharp & Dohme","result":"Median overall survival 24.7 against 27.3 months (hazard ratio 1.04, 95 percent confidence interval 0.88 to 1.22) and radiographic progression-free survival 10.4 against 9.0 months (0.98, 0.84 to 1.14); stopped for futility. Grade 3 or higher treatment-related adverse events 31.2 against 10.8 percent.","started":"2019-07-28","startedType":"actual","yearReported":2025,"enrolled":1244,"enrolledBasis":"randomised","enrolledNote":"1,244 participants were randomly assigned between 21 August 2019 and 10 June 2022, 621 to pembrolizumab with enzalutamide and 623 to placebo with enzalutamide.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab with enzalutamide","n":621,"value":24.7},{"name":"Placebo with enzalutamide","n":623,"value":27.3}],"hr":1.04,"ci":[0.88,1.22],"p":"0.66","source":"https://doi.org/10.1016/j.annonc.2025.05.007"},{"endpoint":"Grade 3 or higher treatment-related adverse events","unit":"%","arms":[{"name":"Pembrolizumab with enzalutamide","n":615,"value":31.2},{"name":"Placebo with enzalutamide","n":620,"value":10.8}],"source":"https://doi.org/10.1016/j.annonc.2025.05.007"}],"replication":"IMbassador250 found the same for atezolizumab with enzalutamide in 759 men (hazard ratio 1.12)."},{"id":"keynote-671","kind":"trial","name":"KEYNOTE-671","aka":[],"tldr":"Showed that immunotherapy given both before and after lung cancer surgery lengthens survival.","summary":"KEYNOTE-671, trial NCT03425643 sponsored by Merck and reported in 2023, showed that pembrolizumab given both before and after surgery for resectable stage II to IIIB non-small-cell lung cancer lengthens survival. It randomised 797 patients to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab, or placebo, met its primary endpoints of event-free survival and overall survival, and led to FDA approval of the perioperative regimen in October 2023, the first such regimen with a survival benefit. OnCo links it to the perioperative term and to Heather A. Wakelee and Tina Cascone, and its findings are consistent with CheckMate 816, AEGEAN, CheckMate 77T and NEOTORCH. Whether the adjuvant phase adds to neoadjuvant treatment alone has never been tested head to head, which is the trial's main unanswered question. Pembrolizumab has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT03425643","url":"https://clinicaltrials.gov/study/NCT03425643"}],"tags":[],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":[],"people":["heather-wakelee","tina-cascone"],"bottlenecks":[],"keyPapers":["paper-keynote-671-n-engl-j-med-2023","paper-keynote-671-ann-oncol-2026-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03425643","phase":"3","setting":"Resectable stage II-IIIB NSCLC: neoadjuvant pembrolizumab + chemotherapy then adjuvant pembrolizumab vs placebo","sponsor":"Merck","result":"EFS HR 0.58; OS HR 0.72.","started":"2018-04-24","startedType":"actual","yearReported":2023,"enrolled":797,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy → pembrolizumab","n":397,"value":47.2},{"name":"Placebo + chemotherapy → placebo","n":400,"value":18.3}],"hr":0.59,"ci":[0.48,0.72],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2302983"},{"endpoint":"Overall survival at 36 months","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab arm","value":71.3},{"name":"Placebo arm","value":64}],"hr":0.72,"ci":[0.56,0.93],"p":"0.005","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02241-2/fulltext"}],"replication":"Consistent with CheckMate 816, AEGEAN, CheckMate 77T, and NEOTORCH; the first perioperative regimen with an OS benefit."},{"id":"keynote-689","kind":"trial","name":"KEYNOTE-689","aka":[],"tldr":"The first new treatment for curable head and neck cancer in six years: immunotherapy around surgery doubled the time patients stayed free of events.","summary":"Presented AACR April 2025; FDA approval 12 June 2025 for PD-L1 CPS ≥1. In the CPS ≥1 population (n=682), median EFS 59.7 vs 29.6 months. Major pathological response in ~10% of the neoadjuvant arm predicted excellent outcomes. First perioperative approval in HNSCC and the first HNSCC approval since 2019.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03765918","url":"https://clinicaltrials.gov/study/NCT03765918"},{"label":"FDA approval, Merck","url":"https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-for-pd-l1-resectable-locally-advanced-head-neck-squamous-cell-carcinoma-as-neoadjuvant-treatment-continued-as-adjuvant-treatment-combined-with-radiother/"}],"tags":[],"related":[],"cancers":["head-and-neck","hpv-negative-head-and-neck-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":["pd1"],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","efs","cps"],"trials":[],"people":["ravindra-uppaluri"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03765918","phase":"3","setting":"Resectable stage III-IVA HNSCC: neoadjuvant pembrolizumab, surgery, then adjuvant pembrolizumab with (chemo)radiation vs surgery and (chemo)radiation","sponsor":"Merck","result":"Median EFS 59.7 vs 29.6 months (CPS ≥1).","started":"2018-12-17","startedType":"actual","yearReported":2025,"enrolled":714,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival (CPS ≥1)","primary":true,"unit":"months","arms":[{"name":"Perioperative pembrolizumab","n":682,"value":59.7},{"name":"Standard of care","value":29.6}],"source":"https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-for-pd-l1-resectable-locally-advanced-head-neck-squamous-cell-carcinoma-as-neoadjuvant-treatment-continued-as-adjuvant-treatment-combined-with-radiother/"}],"replication":"No second phase 3 yet; consistent with neoadjuvant IO benefits in melanoma and lung."},{"id":"keynote-716","kind":"trial","name":"KEYNOTE-716","aka":[],"tldr":"Extended adjuvant immunotherapy to thick node-negative melanomas, a group whose risk of relapse rivals stage III.","summary":"RFS and distant metastasis-free survival improved (FDA approval December 2021 for stage IIB/IIC). Five-year follow-up (ESMO 2025) reported sustained RFS and DMFS benefit; OS not yet mature. The absolute benefit is smaller than in stage III and the trial reignited debate about over-treatment given that most stage II patients never relapse.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03553836","url":"https://clinicaltrials.gov/study/NCT03553836"},{"label":"5-year follow-up, Annals of Oncology 2025","url":"https://www.annalsofoncology.org/article/S0923-7534(25)03159-X/fulltext"}],"tags":[],"related":[],"cancers":["melanoma","stage-ii-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["efs"],"trials":[],"people":["jason-luke"],"bottlenecks":[],"keyPapers":["paper-keynote-716-lancet-2022","paper-keynote-716-lancet-oncol-2022-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03553836","phase":"3","setting":"Resected stage IIB or IIC melanoma: adjuvant pembrolizumab 1 year vs placebo","sponsor":"Merck","result":"RFS and DMFS improved; 5-year benefit sustained (ESMO 2025).","started":"2018-09-12","startedType":"actual","yearReported":2021,"enrolled":976,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free survival (first interim analysis)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab","n":487,"note":"Median not reached in either arm; HR 0.61 (95% CI 0.45-0.82) at the second interim analysis"},{"name":"Placebo","n":489}],"hr":0.65,"ci":[0.46,0.92],"p":"0.0066","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00562-1/fulltext"},{"endpoint":"Distant metastasis-free survival at 36 months (final DMFS analysis)","unit":"%","arms":[{"name":"Pembrolizumab","value":84.4},{"name":"Placebo","value":74.7}],"hr":0.59,"ci":[0.44,0.79],"source":"https://ascopubs.org/doi/10.1200/JCO.23.02355"},{"endpoint":"Recurrence-free survival at 36 months","unit":"%","arms":[{"name":"Pembrolizumab","value":76.2},{"name":"Placebo","value":63.4}],"hr":0.62,"ci":[0.49,0.79],"source":"https://ascopubs.org/doi/10.1200/JCO.23.02355"},{"endpoint":"Recurrence-free survival at 48 months","unit":"%","arms":[{"name":"Pembrolizumab","value":71.3},{"name":"Placebo","value":58.3}],"hr":0.62,"ci":[0.5,0.78],"source":"https://doi.org/10.1016/j.ejca.2025.115381"}],"replication":"Consistent with the stage III adjuvant trials (KEYNOTE-054, CheckMate 238) and with CheckMate 76K (nivolumab in stage IIB/C, RFS HR 0.42), so adjuvant PD-1 benefit in stage II is replicated across two agents. OS not yet significant."},{"id":"keynote-775","kind":"trial","name":"KEYNOTE-775 / Study 309","aka":[],"tldr":"A pill that blocks tumour blood vessels plus immunotherapy extended survival after chemotherapy, including in tumours that immunotherapy alone does not touch.","summary":"OS 18.3 vs 11.4 months in all comers (HR 0.62) and 17.4 vs 12.0 months in pMMR (HR 0.68); PFS 7.2 vs 3.8 months (NEJM 2022). Full approval 2021 for pMMR disease after platinum. Toxicity is substantial: hypertension, hypothyroidism, diarrhoea, and dose reductions in two-thirds of patients. Now largely used after first-line chemo-immunotherapy.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03517449","url":"https://clinicaltrials.gov/study/NCT03517449"},{"label":"NEJM 2022","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2108330"}],"tags":[],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer","endometrial-nsmp"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":["vegf","pd1"],"drugs":["lenvatinib","pembrolizumab"],"companies":["eisai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03517449","phase":"3","setting":"Advanced endometrial cancer after platinum: lenvatinib + pembrolizumab vs doxorubicin or weekly paclitaxel","sponsor":"Eisai / Merck","result":"OS 18.3 vs 11.4 months (HR 0.62).","started":"2018-06-11","startedType":"actual","yearReported":2021,"enrolled":827,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (all comers)","primary":true,"unit":"months","arms":[{"name":"Lenvatinib + pembrolizumab","n":411,"value":18.3},{"name":"Chemotherapy","n":416,"value":11.4}],"hr":0.62,"ci":[0.51,0.75],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2108330"},{"endpoint":"Progression-free survival (all comers)","primary":true,"unit":"months","arms":[{"name":"Lenvatinib + pembrolizumab","value":7.2},{"name":"Chemotherapy","value":3.8}],"hr":0.56,"ci":[0.47,0.66],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2108330"}]},{"id":"keynote-811","kind":"trial","name":"KEYNOTE-811","aka":[],"tldr":"KEYNOTE-811 showed that adding the immunotherapy pembrolizumab to trastuzumab and chemotherapy shrank HER2-positive stomach cancers more often and kept them under control for longer, with the gain concentrated in tumours that also express PD-L1.","summary":"KEYNOTE-811 randomised 738 patients with previously untreated HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma to trastuzumab plus fluoropyrimidine and platinum chemotherapy with pembrolizumab or with placebo. The dual primary endpoints were progression-free and overall survival.\n\nAt the first interim analysis the pembrolizumab arm had a markedly higher objective response rate, which supported accelerated approval in the United States in May 2021. Later analyses showed longer progression-free survival, with the benefit concentrated in tumours with a PD-L1 combined positive score of 1 or more, and the indication was narrowed to that group in 2023. Overall survival results followed in the same direction in the PD-L1-positive population.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03615326","url":"https://clinicaltrials.gov/study/NCT03615326"}],"tags":["subtype-trials"],"related":[],"cancers":["gastric-her2-positive","gastric"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","trastuzumab","cisplatin","fluorouracil","capecitabine","oxaliplatin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["yelena-janjigian"],"bottlenecks":[],"keyPapers":["paper-keynote-811-janjigian-lancet-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03615326","phase":"3","setting":"Untreated HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma: trastuzumab and fluoropyrimidine-platinum chemotherapy with pembrolizumab or placebo","sponsor":"Merck & Co. (MSD)","result":"Higher response rate and longer progression-free survival with pembrolizumab added to trastuzumab and chemotherapy, with benefit concentrated in PD-L1-positive tumours; accelerated approval in May 2021, later limited to PD-L1 combined positive score of 1 or more.","started":"2018-10-05","startedType":"actual","yearReported":2021,"enrolled":738,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (second interim analysis)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + trastuzumab + chemotherapy","n":350,"value":10,"note":"Median follow-up 28.3 months"},{"name":"Placebo + trastuzumab + chemotherapy","n":348,"value":8.1}],"hr":0.72,"ci":[0.6,0.87],"p":"0.0002","source":"https://doi.org/10.1016/S0140-6736(23)02033-0"},{"endpoint":"Overall survival (second interim analysis)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + trastuzumab + chemotherapy","n":350,"value":20},{"name":"Placebo + trastuzumab + chemotherapy","n":348,"value":16.9}],"hr":0.87,"ci":[0.72,1.06],"p":"0.084","source":"https://doi.org/10.1016/S0140-6736(23)02033-0"},{"endpoint":"Progression-free survival (third interim analysis)","unit":"months","arms":[{"name":"Pembrolizumab + trastuzumab + chemotherapy","n":350,"value":10,"note":"Median follow-up 38.4 months"},{"name":"Placebo + trastuzumab + chemotherapy","n":348,"value":8.1}],"hr":0.73,"ci":[0.61,0.87],"source":"https://doi.org/10.1016/S0140-6736(23)02033-0"},{"endpoint":"Overall survival (third interim analysis)","unit":"months","arms":[{"name":"Pembrolizumab + trastuzumab + chemotherapy","n":350,"value":20,"note":"Did not meet prespecified significance criteria; continues to final analysis"},{"name":"Placebo + trastuzumab + chemotherapy","n":348,"value":16.8}],"hr":0.84,"ci":[0.7,1.01],"source":"https://doi.org/10.1016/S0140-6736(23)02033-0"}]},{"id":"keynote-826","kind":"trial","name":"KEYNOTE-826","aka":[],"tldr":"Added nearly ten months of life for women with advanced cervical cancer and made immunotherapy part of first-line treatment.","summary":"KEYNOTE-826, trial NCT03635567 sponsored by Merck and reported in 2021 with the final analysis in JCO in 2023, added nearly ten months of life for women with persistent, recurrent or metastatic cervical cancer and made immunotherapy part of first-line treatment. It randomised 617 patients to pembrolizumab or placebo with platinum and paclitaxel, with bevacizumab given to about 63 percent at investigator discretion, met its primary overall survival endpoints in all comers and in PD-L1-positive disease, and led to FDA approval in October 2021 for PD-L1-positive disease. OnCo links it to cervical and vaginal cancer, PD-1 as a target, pembrolizumab, bevacizumab, cisplatin, paclitaxel, the CPS term, Nicoletta Colombo and Bradley J. Monk. Whether PD-L1-negative patients benefit is the open question the label leaves.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03635567","url":"https://clinicaltrials.gov/study/NCT03635567"},{"label":"Final OS, JCO 2023","url":"https://ascopubs.org/doi/10.1200/JCO.23.00810"}],"tags":[],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab","bevacizumab","cisplatin","paclitaxel"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["cps"],"trials":[],"people":["nicoletta-colombo","bradley-monk"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03635567","phase":"3","setting":"Persistent, recurrent, or metastatic cervical cancer, first line: pembrolizumab + platinum-paclitaxel ± bevacizumab vs placebo + chemotherapy ± bevacizumab","sponsor":"Merck","result":"OS 26.4 vs 16.8 months (HR 0.63), all comers.","started":"2018-10-25","startedType":"actual","yearReported":2021,"enrolled":617,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (all comers)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemo ± bev","n":308,"value":26.4},{"name":"Placebo + chemo ± bev","n":309,"value":16.8}],"hr":0.63,"ci":[0.52,0.77],"source":"https://ascopubs.org/doi/10.1200/JCO.23.00810"},{"endpoint":"Overall survival (CPS ≥1)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemo ± bev","value":28.6},{"name":"Placebo + chemo ± bev","value":16.5}],"hr":0.6,"ci":[0.49,0.74],"source":"https://ascopubs.org/doi/10.1200/JCO.23.00810"}],"replication":"BEATcc (atezolizumab + chemotherapy + bevacizumab) and COMPASSION-16 (cadonilimab) reproduced the first-line survival benefit with different antibodies."},{"id":"keynote-859","kind":"trial","name":"KEYNOTE-859","aka":[],"tldr":"Confirmed that adding a PD-1 blocker to first-line chemotherapy helps in stomach cancer, with the biggest gain in tumours rich in PD-L1.","summary":"KEYNOTE-859, trial NCT03675737 sponsored by Merck and reported in 2023, confirmed that adding the PD-1 antibody pembrolizumab to first-line chemotherapy helps in HER2-negative advanced gastric and gastro-oesophageal junction adenocarcinoma, with the biggest gain in tumours rich in PD-L1. It randomised 1,579 patients and met its primary overall survival endpoint in all randomised patients, with progressively larger effects at CPS 1 and CPS 10 or higher, leading to FDA approval in November 2023 for all PD-L1 levels while the EMA restricted it to CPS 1 or higher. OnCo links it to gastric cancer, PD-1 as a target, pembrolizumab, the CPS term and Sun Young Rha, and it replicates CheckMate 649. As with its predecessor, whether PD-L1-negative patients should receive immunotherapy is the open question the regional labels disagree on.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03675737","url":"https://clinicaltrials.gov/study/NCT03675737"}],"tags":[],"related":[],"cancers":["gastric","gastric-pdl1-high"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["cps"],"trials":[],"people":["rha-sun-young"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03675737","phase":"3","setting":"First-line HER2-negative advanced gastric/GEJ adenocarcinoma: pembrolizumab + chemotherapy vs placebo + chemotherapy","sponsor":"Merck","result":"OS HR 0.78 (all); CPS ≥10 OS 15.7 vs 11.8 months (HR 0.65).","started":"2018-11-08","startedType":"actual","yearReported":2023,"enrolled":1579,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, all randomised","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy","n":790,"value":12.9},{"name":"Placebo + chemotherapy","n":789,"value":11.5}],"hr":0.78,"ci":[0.7,0.87],"source":"https://www.annalsofoncology.org/article/S0923-7534(24)04258-3/fulltext"},{"endpoint":"Overall survival, CPS ≥10","unit":"months","arms":[{"name":"Pembrolizumab + chemotherapy","value":15.7},{"name":"Placebo + chemotherapy","value":11.8}],"hr":0.65,"ci":[0.53,0.79],"source":"https://www.annalsofoncology.org/article/S0923-7534(24)04258-3/fulltext"}],"replication":"Replicates CheckMate 649."},{"id":"keynote-921","kind":"trial","name":"KEYNOTE-921","aka":["KEYNOTE-921","MK-3475-921"],"tldr":"Adding pembrolizumab to chemotherapy for advanced prostate cancer did not work, and it added side effects and lung inflammation.","summary":"KEYNOTE-921 randomised 1,030 men whose metastatic castration-resistant prostate cancer had progressed after androgen deprivation and one androgen receptor pathway inhibitor to pembrolizumab or placebo with docetaxel and prednisone.\n\nAt the first interim analysis (data cutoff 27 September 2021), median radiographic progression-free survival was 8.6 months (95 percent confidence interval 8.3 to 10.2) with pembrolizumab against 8.3 months (8.2 to 8.5) with placebo, hazard ratio 0.85 (0.71 to 1.01, p=0.03), which did not meet the prespecified boundary. At the final analysis (median follow-up 22.7 months), median overall survival was 19.6 months (18.2 to 20.9) against 19.0 months (17.9 to 20.9), hazard ratio 0.92 (0.78 to 1.09, p=0.17).\n\nGrade 3 or higher treatment-related adverse events occurred in 43.2 percent with pembrolizumab and 36.6 percent with placebo. Two participants on pembrolizumab and seven on placebo died of a treatment-related adverse event. Pneumonitis was the commonest immune-mediated event, 7.0 against 3.1 percent.\n\nThe separately published patient-reported outcomes found no meaningful difference in time to pain progression, median 21.1 months against not reached, hazard ratio 1.05 (0.77 to 1.43), or in health-related quality of life. Adding the checkpoint inhibitor neither helped nor harmed how men felt; it simply did not work.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03834506","url":"https://clinicaltrials.gov/study/NCT03834506"},{"label":"KEYNOTE-921 (Journal of Clinical Oncology 2025)","url":"https://doi.org/10.1200/JCO-24-01283"},{"label":"KEYNOTE-921 patient-reported outcomes (European Urology Oncology 2026)","url":"https://doi.org/10.1016/j.euo.2025.02.015"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":["pd1"],"drugs":["pembrolizumab","docetaxel","prednisone"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["castration-resistance","qol-pro"],"trials":["keynote-641","keynote-991","imbassador250"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03834506","phase":"3","setting":"Metastatic castration-resistant prostate cancer progressing after androgen deprivation and one androgen receptor pathway inhibitor: pembrolizumab or placebo with docetaxel and concomitant prednisone, with dual primary endpoints of radiographic progression-free survival by blinded independent central review and overall survival","sponsor":"Merck Sharp & Dohme","result":"Median radiographic progression-free survival 8.6 against 8.3 months (hazard ratio 0.85, 95 percent confidence interval 0.71 to 1.01) and overall survival 19.6 against 19.0 months (0.92, 0.78 to 1.09); neither endpoint met.","started":"2019-05-02","startedType":"actual","yearReported":2025,"enrolled":1030,"enrolledBasis":"randomised","enrolledNote":"1,030 participants were randomly assigned, 515 to each arm, between 30 May 2019 and 17 June 2021.","outcomes":[{"endpoint":"Radiographic progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab with docetaxel and prednisone","n":515,"value":8.6,"note":"Did not meet the prespecified significance boundary."},{"name":"Placebo with docetaxel and prednisone","n":515,"value":8.3}],"hr":0.85,"ci":[0.71,1.01],"p":"0.03","source":"https://doi.org/10.1200/JCO-24-01283"},{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab with docetaxel and prednisone","n":515,"value":19.6},{"name":"Placebo with docetaxel and prednisone","n":515,"value":19}],"hr":0.92,"ci":[0.78,1.09],"p":"0.17","source":"https://doi.org/10.1200/JCO-24-01283"}],"replication":"CheckMate 7DX tested nivolumab with docetaxel in the same setting; a pooled analysis of the two trials, 2,060 men, found no difference in radiographic progression-free survival (hazard ratio 0.91, 0.81 to 1.03) or overall survival (0.99, 0.87 to 1.12)."},{"id":"keynote-966","kind":"trial","name":"KEYNOTE-966","aka":[],"tldr":"A second immunotherapy trial confirmed the modest survival benefit of adding PD-1 blockade to chemotherapy in bile duct cancer.","summary":"KEYNOTE-966, trial NCT04003636 sponsored by Merck and reported in 2023, was the second immunotherapy trial to confirm a modest survival benefit from adding PD-1 blockade to chemotherapy in first-line advanced biliary tract cancer. It randomised 1,069 patients to pembrolizumab or placebo with gemcitabine and cisplatin, with gemcitabine continued beyond eight cycles in both arms, met its primary overall survival endpoint and led to approval in October 2023. OnCo links it to biliary tract and gallbladder cancer, pembrolizumab, gemcitabine plus cisplatin and the pairing of chemotherapy with PD-1 or PD-L1 blockade, and it replicates TOPAZ-1. Whether the modest median gain justifies routine use for every patient, given the cost, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04003636","url":"https://clinicaltrials.gov/study/NCT04003636"},{"label":"NICE TA966: pembrolizumab with gemcitabine and cisplatin for untreated advanced biliary tract cancer (terminated appraisal)","url":"https://www.nice.org.uk/guidance/terminated/ta966"},{"label":"NICE TA966: pembrolizumab with gemcitabine and cisplatin for biliary tract cancer (terminated appraisal, 2024)","url":"https://www.nice.org.uk/guidance/terminated/ta966"}],"tags":[],"related":[],"cancers":["cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","gallbladder"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","gemcitabine-cisplatin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-keynote-966-lancet-2023"],"journals":[],"dependsOn":[],"notes":["In the UK, NICE could not appraise pembrolizumab with gemcitabine and cisplatin for biliary tract cancer because no evidence submission was made (TA966, terminated), so the routinely funded NHS immunotherapy partner is durvalumab (TA944).","Gallbladder cancer: eligibility was intrahepatic or extrahepatic cholangiocarcinoma or gallbladder cancer and randomisation was stratified by site of origin (gallbladder, intrahepatic or extrahepatic), geographic region and disease stage; the proportion with gallbladder cancer and the gallbladder hazard ratio are in the Lancet paper's tables rather than its abstract and are not quoted here. UK sites: Aberdeen, Belfast, Coventry, London (Royal Free, Royal Marsden, Hammersmith), Manchester and Sutton (registry). NICE terminated its appraisal of pembrolizumab with gemcitabine and cisplatin for biliary tract cancer (TA966, April 2024) because no evidence submission was made, so durvalumab (TA944) is the NHS chemo-immunotherapy option."],"nct":"NCT04003636","phase":"3","setting":"First-line advanced biliary tract cancer: gemcitabine-cisplatin + pembrolizumab vs + placebo","sponsor":"Merck","result":"OS 12.7 vs 10.9 months, HR 0.83.","started":"2019-09-24","startedType":"actual","yearReported":2023,"enrolled":1069,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + GemCis","n":533,"value":12.7},{"name":"Placebo + GemCis","n":536,"value":10.9}],"hr":0.83,"ci":[0.72,0.95],"p":"0.0034","source":"https://doi.org/10.1016/S0140-6736(23)00727-4"}],"replication":"Replicates TOPAZ-1."},{"id":"keynote-991","kind":"trial","name":"KEYNOTE-991","aka":["KEYNOTE-991","MK-3475-991"],"tldr":"The last attempt to make immunotherapy work in prostate cancer, this time as early as possible. It was stopped for futility and made rashes and serious side effects much commoner.","summary":"KEYNOTE-991 tested whether checkpoint blockade would work if given early, before castration resistance, when the tumour is less heavily pretreated. It randomised 1,251 men with metastatic hormone-sensitive prostate cancer who had not had a next-generation hormonal agent to pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles, with enzalutamide 160 mg daily and continuous androgen deprivation.\n\nAt the first interim analysis, median follow-up 21.1 months, radiographic progression-free survival was not superior with pembrolizumab: median not reached in either arm, hazard ratio 1.20 (95 percent confidence interval 0.96 to 1.49, p=0.9467). Median overall survival was not reached in either arm, hazard ratio 1.16 (0.88 to 1.53), not formally tested under the multiplicity strategy. The trial did not meet its primary endpoint and was stopped for futility.\n\nGrade 3 or higher adverse events occurred in 61.9 percent with pembrolizumab against 38.1 percent with placebo, and serious adverse events in 40.3 against 23.2 percent. Rash of any grade occurred in 25.1 against 9.3 percent, identified as an additional safety signal for the combination.\n\nWith IMbassador250, KEYNOTE-641 and KEYNOTE-921, this closes the unselected checkpoint inhibitor question in prostate cancer. The remaining immunotherapy indication is pembrolizumab for the roughly 3 percent of men with mismatch repair deficient or microsatellite instability high tumours, where selection does the work.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04191096","url":"https://clinicaltrials.gov/study/NCT04191096"},{"label":"KEYNOTE-991 (Annals of Oncology 2025)","url":"https://doi.org/10.1016/j.annonc.2025.05.008"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["checkpoint-inhibitor","androgen-deprivation"],"targets":["pd1","androgen-receptor"],"drugs":["pembrolizumab","enzalutamide"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["mcrpc-mhspc","arpi","adt"],"trials":["keynote-641","keynote-921","imbassador250","arches","enzamet"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04191096","phase":"3","setting":"Metastatic hormone-sensitive prostate cancer not previously treated with a next-generation hormonal agent: pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles with enzalutamide 160 mg daily and continuous androgen deprivation, with primary endpoints of radiographic progression-free survival and overall survival","sponsor":"Merck Sharp & Dohme","result":"Radiographic progression-free survival hazard ratio 1.20 (95 percent confidence interval 0.96 to 1.49, p=0.9467), medians not reached; stopped for futility. Grade 3 or higher adverse events 61.9 against 38.1 percent and rash 25.1 against 9.3 percent.","started":"2020-02-12","startedType":"actual","yearReported":2025,"enrolled":1251,"enrolledBasis":"randomised","enrolledNote":"1,251 participants were randomly assigned between 2 March 2020 and 9 August 2021, 626 to pembrolizumab and 625 to placebo.","outcomes":[{"endpoint":"Radiographic progression-free survival","primary":true,"arms":[{"name":"Pembrolizumab with enzalutamide and androgen deprivation","n":626,"note":"median not reached"},{"name":"Placebo with enzalutamide and androgen deprivation","n":625,"note":"median not reached"}],"hr":1.2,"ci":[0.96,1.49],"p":"0.9467","source":"https://doi.org/10.1016/j.annonc.2025.05.008"},{"endpoint":"Grade 3 or higher adverse events","unit":"%","arms":[{"name":"Pembrolizumab with enzalutamide and androgen deprivation","n":626,"value":61.9},{"name":"Placebo with enzalutamide and androgen deprivation","n":625,"value":38.1}],"source":"https://doi.org/10.1016/j.annonc.2025.05.008"}],"replication":"Consistent with IMbassador250, KEYNOTE-641 and KEYNOTE-921 in castration-resistant disease; the failure is now shown at both ends of the disease course."},{"id":"keynote-a18","kind":"trial","name":"KEYNOTE-A18 / ENGOT-cx11 / GOG-3047","aka":[],"tldr":"Adding immunotherapy to curative chemoradiation for locally advanced cervical cancer improved both control and survival, the first such advance in two decades.","summary":"KEYNOTE-A18, also ENGOT-cx11 and GOG-3047, trial NCT04221945 sponsored by Merck and published in the Lancet in 2024, showed that adding pembrolizumab to curative cisplatin chemoradiation and brachytherapy for high-risk locally advanced cervical cancer improves both disease control and survival, the first such advance in two decades. It randomised 1,060 patients, met its primary progression-free survival endpoint at 24 months and its overall survival endpoint at 36 months, and led to FDA approval in January 2024 for FIGO 2014 stage III to IVA disease, the first change to the cisplatin-radiation standard set in 1999. CALLA with durvalumab was negative, so the benefit is not yet reproduced with another agent, and why the two trials diverged is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04221945","url":"https://clinicaltrials.gov/study/NCT04221945"},{"label":"PFS, Lancet 2024","url":"https://doi.org/10.1016/S0140-6736(24)00317-9"},{"label":"OS, Lancet 2024","url":"https://doi.org/10.1016/S0140-6736(24)01808-7"}],"tags":[],"related":[],"cancers":["cervical","locally-advanced-cervical-cancer"],"sections":[],"technologies":["imrt-igrt","brachytherapy","checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab"],"companies":["gog-foundation"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["domenica-lorusso","bradley-monk"],"bottlenecks":[],"keyPapers":["paper-keynote-a18-pfs-lancet-2024","paper-keynote-a18-os-lancet-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04221945","phase":"3","setting":"Newly diagnosed high-risk locally advanced cervical cancer (FIGO 2014 IB2-IIB node-positive or III-IVA): pembrolizumab + cisplatin chemoradiation + brachytherapy, then pembrolizumab, vs chemoradiation","sponsor":"Merck","result":"PFS HR 0.70; 36-month OS 82.6% vs 74.8% (HR 0.67).","started":"2020-05-12","startedType":"actual","yearReported":2023,"enrolled":1060,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 24 months","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab + CRT","n":529,"value":68},{"name":"Placebo + CRT","n":531,"value":57}],"hr":0.7,"ci":[0.55,0.89],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00317-9/fulltext"},{"endpoint":"Overall survival at 36 months","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab + CRT","value":82.6},{"name":"Placebo + CRT","value":74.8}],"hr":0.67,"ci":[0.5,0.9],"source":"https://pubmed.ncbi.nlm.nih.gov/39288779/"}],"replication":"CALLA (durvalumab + chemoradiation) was negative, so the benefit is not yet reproduced with another agent; differences in risk population and drug are debated."},{"id":"keynote-b96","kind":"trial","name":"KEYNOTE-B96 / ENGOT-ov65","aka":[],"tldr":"After a decade of failures, the first immunotherapy trial to extend survival in ovarian cancer, leading to the first checkpoint-inhibitor approval in the disease.","summary":"KEYNOTE-B96, also ENGOT-ov65, trial NCT05116189 sponsored by Merck and published in the Lancet in 2026, was, after a decade of failures, the first immunotherapy trial to extend survival in ovarian cancer, leading to the first checkpoint inhibitor approval in the disease. It randomised women with platinum-resistant recurrent disease to pembrolizumab or placebo with weekly paclitaxel, with or without bevacizumab, met its primary progression-free survival endpoint and improved overall survival in PD-L1-positive tumours, with a smaller survival benefit overall, and FDA approval followed in February 2026 for PD-L1-positive disease, including the subcutaneous formulation. OnCo links it to ovarian cancer, PD-1 and PD-L1 as targets, pembrolizumab, paclitaxel, bevacizumab and the CPS term. Why immunotherapy works in resistant but not first-line disease is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05116189","url":"https://clinicaltrials.gov/study/NCT05116189"},{"label":"FDA approval, ASCO Post","url":"https://ascopost.com/issues/february-25-2026/fda-approves-pembrolizumab-with-paclitaxel-for-platinum-resistant-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-carcinoma/"}],"tags":[],"related":["src-asco-post"],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","pdl1"],"drugs":["pembrolizumab","paclitaxel","bevacizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["cps"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05116189","phase":"3","setting":"Platinum-resistant recurrent ovarian cancer, 1-2 prior lines: pembrolizumab + weekly paclitaxel ± bevacizumab vs placebo + paclitaxel ± bevacizumab","sponsor":"Merck","result":"OS 18.2 vs 14.0 months in CPS ≥1 (HR 0.76); ITT OS HR 0.82.","started":"2021-12-13","startedType":"actual","yearReported":2025,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (CPS ≥1)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + paclitaxel ± bev","value":8.3},{"name":"Placebo + paclitaxel ± bev","value":7.2}],"hr":0.72,"ci":[0.58,0.89],"source":"https://pubmed.ncbi.nlm.nih.gov/41974150/"},{"endpoint":"Overall survival (CPS ≥1)","unit":"months","arms":[{"name":"Pembrolizumab + paclitaxel ± bev","value":18.2},{"name":"Placebo + paclitaxel ± bev","value":14}],"hr":0.76,"ci":[0.61,0.94],"source":"https://pubmed.ncbi.nlm.nih.gov/41974150/"},{"endpoint":"Overall survival (all patients)","unit":"months","arms":[{"name":"Pembrolizumab + paclitaxel ± bev","value":17.7},{"name":"Placebo + paclitaxel ± bev","value":14}],"hr":0.82,"ci":[0.69,0.97],"source":"https://www.targetedonc.com/view/final-keynote-b96-analysis-confirms-survival-benefits-with-pembrolizumab-regimen-in-ovarian-cancer"}],"replication":"First positive phase 3; earlier trials (JAVELIN Ovarian 200, IMagyn050, DUO-O) were negative for OS."},{"id":"nct05294172","kind":"trial","name":"KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma","aka":[],"tldr":"A phase 3 trial testing KL-A167 in nasopharyngeal carcinoma, active and no longer recruiting.","summary":"KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma is a phase 3 interventional study registered as NCT05294172, led by Sichuan Kelun-Biotech Biopharmaceutical, and active but no longer recruiting on the registry. Official title: KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma: A Randomised, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial. Planned enrolment is 295 participants (actual). The study started in 2022-06-07 and primary completion is expected in 2027-12. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05294172","url":"https://clinicaltrials.gov/study/NCT05294172"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nasopharyngeal","recurrent-metastatic-nasopharyngeal-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["kl-a167"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05294172","phase":"3","setting":"KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical","started":"2022-06-07","startedType":"actual","enrolled":295,"enrolledBasis":"registry","outcomes":[]},{"id":"klass-01","kind":"trial","name":"KLASS-01","aka":[],"tldr":"KLASS-01 showed that removing an early stomach cancer through keyhole surgery is as safe for long-term survival as open surgery and causes fewer wound complications, which made laparoscopic gastrectomy the standard for early gastric cancer in Korea and beyond.","summary":"KLASS-01 was a multicentre non-inferiority trial run by the Korean Laparoendoscopic Gastrointestinal Surgery Study group in patients with clinical stage I gastric adenocarcinoma. Patients were randomised to laparoscopy-assisted or open distal gastrectomy with standard lymph node dissection.\n\nThe short-term report found fewer wound complications and similar mortality with the laparoscopic approach. The primary analysis, published in JAMA Oncology in 2019, showed that five-year overall survival after laparoscopic surgery was non-inferior to open surgery. With the Japanese JCOG0912 trial it settled the question for early distal gastric cancer; the follow-on KLASS-02 addressed locally advanced disease.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00452751","url":"https://clinicaltrials.gov/study/NCT00452751"}],"tags":["subtype-trials"],"related":["paper-jcog0912-katai-lancet-gastroenterol-hepatol-2020"],"cancers":["early-gastric-cancer","gastric"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["ncc-korea"],"pathways":[],"terms":[],"trials":[],"people":["hyung-ho-kim"],"bottlenecks":[],"keyPapers":["paper-klass-01-kim-jama-oncol-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00452751","phase":"3","setting":"Clinical stage I gastric cancer: laparoscopy-assisted distal gastrectomy against open distal gastrectomy, with five-year overall survival as the primary endpoint","sponsor":"National Cancer Center Korea (Korean Laparoendoscopic Gastrointestinal Surgery Study Group)","result":"Laparoscopic distal gastrectomy was non-inferior to open surgery for five-year overall survival in stage I gastric cancer, with fewer wound complications.","started":"2006-02","yearReported":2019,"enrolled":1400,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 5 years (non-inferiority)","primary":true,"unit":"%","arms":[{"name":"Laparoscopic distal gastrectomy","n":705,"value":94.2,"note":"Difference 0.9 percentage points; non-inferiority margin -5 points"},{"name":"Open distal gastrectomy","n":711,"value":93.3}],"p":"0.64","source":"https://doi.org/10.1001/jamaoncol.2018.6727"},{"endpoint":"Cancer-specific survival at 5 years","unit":"%","arms":[{"name":"Laparoscopic distal gastrectomy","n":705,"value":97.1},{"name":"Open distal gastrectomy","n":711,"value":97.2}],"p":"0.91","source":"https://doi.org/10.1001/jamaoncol.2018.6727"}]},{"id":"nct05985109","kind":"trial","name":"KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of regorafenib in colorectal cancer, run by Peking University Cancer Hospital & Institute, now recruiting.","summary":"KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT05985109 by Peking University Cancer Hospital & Institute, with a registry enrolment figure of 98 participants, started 2023-10-26 and due to reach its primary completion in 2026-12-31. Interventions recorded: KN046; regorafenib. Conditions listed: Colorectal Cancer. Primary outcome: Overall response rate. Colorectal eligibility wording from the registry: \"Histologically confirmed colorectal adenocarcinoma, including signet ring cell carcinoma and mucinous adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05985109","url":"https://clinicaltrials.gov/study/NCT05985109"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["regorafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05985109","phase":"2","setting":"A Phase II Multi-cohort Clinical Study Evaluating The Efficacy and Safety of KN046 in Combination With Regorafenib for Metastatic Microsatellite-Stable Colorectal Cancer: a Phase II Multi-cohort Study","sponsor":"Peking University Cancer Hospital & Institute","started":"2023-10-26","startedType":"actual","enrolled":98,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05427383","kind":"trial","name":"KN026 in Combination With Chemotherapy in HER2 Positive Gastric Cancer Subjects Who Have Failed First-line Therapy","aka":[],"tldr":"A phase 2/3 trial of Docetaxel in gastric & gastro-oesophageal junction cancer, run by Shanghai JMT-Bio Inc., now recruiting.","summary":"KN026 in Combination With Chemotherapy in HER2 Positive Gastric Cancer Subjects Who Have Failed First-line Therapy is a phase 2/3 interventional study registered as NCT05427383 by Shanghai JMT-Bio Inc., with 286 participants planned, started 2022-04-07 and due to reach its primary completion in 2025-11. Interventions recorded: KN026/Placbo Injection, Paclitaxel Injection, Docetaxel Injection and Irinotecan Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05427383","url":"https://clinicaltrials.gov/study/NCT05427383"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05427383","phase":"2/3","setting":"A Randomized, Multicenter, Phase Ⅱ/Ш Clinical Study to Evaluate the Efficacy of KN026 in Combination With Chemotherapy in Subjects With HER2 Positive Advanced Unresectable or Metastatic Gastric Cancer (Including Gastro-esophageal Junction Adenocarcinoma) Who Have Failed First-line Therapy.","sponsor":"Shanghai JMT-Bio Inc.","started":"2022-04-07","startedType":"actual","enrolled":286,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05985707","kind":"trial","name":"KN026 Plus Chemotherapy ± KN-046 in HER2 Positive Colorectal Cancer and Biliary Carcinoma","aka":[],"tldr":"A phase 2 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by Peking University Cancer Hospital & Institute, not yet recruiting.","summary":"KN026 Plus Chemotherapy ± KN-046 in HER2 Positive Colorectal Cancer and Biliary Carcinoma is a phase 2 interventional study registered as NCT05985707 by Peking University Cancer Hospital & Institute, with a registry enrolment figure of 80 participants, started 2023-08-15 and due to reach its primary completion in 2026-12-31. Interventions recorded: KN026, KN046, XELOX. Conditions listed: HER2-positive Colorectal Cancer, HER2-positive Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: \"4. Cohort C: Histologically confirmed unresectable HER2-positive biliary tract cancer, including intrahepatic or extrahepatic bile duct cancer or gallbladder cancer: a) Previously untreated with systemic anti-tumor thera\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05985707","url":"https://clinicaltrials.gov/study/NCT05985707"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05985707","phase":"2","setting":"The Efficacy and Safety of KN026 Combination Chemotherapy ± KN046 in HER2-Positive Advanced Colorectal Cancer and Biliary Tract Cancer as First-Line Treatment： a Phase Ⅱ Study","sponsor":"Peking University Cancer Hospital & Institute","started":"2023-08-15","startedType":"estimated","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03667170","kind":"trial","name":"KN035 for dMMR/MSI-H Advanced Solid Tumors","aka":[],"tldr":"A phase 2 trial of Envafolimab in advanced solid tumours, run by 3D Medicines (Sichuan) Co., Ltd., now recruiting.","summary":"KN035 for dMMR/MSI-H Advanced Solid Tumors is a phase 2 interventional study registered as NCT03667170 by 3D Medicines (Sichuan) Co., Ltd., with 200 participants planned, started 2018-08-22 and due to reach its primary completion in 2026-12-30. Interventions recorded: KN035.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03667170","url":"https://clinicaltrials.gov/study/NCT03667170"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["envafolimab"],"companies":["3d-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03667170","phase":"2","setting":"Study of KN035 as Monotherapy in Patients With Advanced Mismatched Repair Deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors","sponsor":"3D Medicines (Sichuan) Co., Ltd.","started":"2018-08-22","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"komet-001","kind":"trial","name":"KOMET-001","aka":[],"tldr":"KOMET-001 was the registration trial for ziftomenib: a quarter of heavily pretreated patients with NPM1-mutated AML reached complete remission on a once-daily pill.","summary":"KOMET-001, trial NCT04067336 sponsored by Kura Oncology and reported in 2025, was the registration study for ziftomenib, in which about a quarter of heavily pretreated patients with relapsed or refractory NPM1-mutated acute myeloid leukaemia reached complete remission on a once-daily tablet. In 112 adults on 600 mg daily the complete remission rate was 23 percent and the overall response rate 33 percent, including patients who had received venetoclax and FLT3 inhibitors, and the FDA approved the drug on 13 November 2025. OnCo links it to acute myeloid leukaemia, menin and the NPM1 mutation as targets and to ziftomenib. Frontline combinations in KOMET-007 show much higher remission rates, as expected for an earlier line, and whether menin inhibitors belong there is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04067336","url":"https://clinicaltrials.gov/study/NCT04067336"},{"label":"FDA approval coverage (ASCO Post)","url":"https://ascopost.com/news/november-2025/fda-approves-ziftomenib-for-npm1-positive-aml/"}],"tags":[],"related":["src-asco-post"],"cancers":["aml","aml-npm1-kmt2a"],"sections":[],"technologies":["epigenetic-drugs"],"targets":["menin","npm1"],"drugs":["ziftomenib"],"companies":["kura-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04067336","phase":"1/2","setting":"Relapsed/refractory NPM1-mutated AML: ziftomenib 600 mg daily monotherapy","sponsor":"Kura Oncology","result":"CR 23%, ORR 33%, median OS 6.6 months.","started":"2019-09-12","startedType":"actual","yearReported":2025,"enrolled":112,"enrolledBasis":"treated","enrolledNote":"ClinicalTrials.gov lists an estimated 263 participants for the phase 1/2 study; 112 is the FDA efficacy population at 600 mg quoted in the approval coverage, while the JCO 2025 phase 2 paper reports 92 patients treated between January 2023 and May 2024.","outcomes":[{"endpoint":"Complete remission","primary":true,"unit":"%","arms":[{"name":"Ziftomenib","n":112,"value":23}],"source":"https://www.appliedclinicaltrialsonline.com/view/fda-approves-komzifti-npm1-mutated-aml-positive-komet-001-trial-data"},{"endpoint":"Overall response rate","unit":"%","arms":[{"name":"Ziftomenib","value":33}]},{"endpoint":"Overall survival (median)","unit":"months","arms":[{"name":"Ziftomenib","value":6.6}]}],"replication":"AUGMENT-101 (revumenib) NPM1 cohort produced a comparable CR+CRh rate, replicating the menin-dependence of NPM1-mutant AML with an independent molecule."},{"id":"nct07622017","kind":"trial","name":"KORTUC (KRC-01) Plus Radiotherapy for Organ Preservation in Rectal Cancer","aka":["K-BOOST"],"tldr":"A phase 2 trial of capecitabine, cAPOX (capecitabine, oxaliplatin) and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Gustave Roussy, Cancer Campus, Grand Paris, not yet recruiting.","summary":"KORTUC (KRC-01) Plus Radiotherapy for Organ Preservation in Rectal Cancer is a phase 2, interventional study registered as NCT07622017 by Gustave Roussy, Cancer Campus, Grand Paris, with a registry enrolment figure of 24 participants, started 2026-07 and due to reach its primary completion in 2029-01. Interventions recorded: KRC-01 (KORTUC); Radiotherapy; Capecitabine; CAPOX; FOLFOX; Optionnal TME. Conditions listed: Rectal Cancer. Primary outcome: Clinical Complete Response (cCR) Rate at Week 24. Colorectal eligibility wording from the registry: \"Histopathologically confirmed locally advanced rectal adenocarcinoma, stage III (high risk)\". Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07622017","url":"https://clinicaltrials.gov/study/NCT07622017"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capecitabine","capox","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07622017","phase":"2","setting":"Phase II Clinical Trial of KORTUC (KRC-01) Combined With Radiotherapy for Locally Advanced Rectal Cancer: Towards a New Organ Preservation Approach","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","started":"2026-07","startedType":"estimated","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07406633","kind":"trial","name":"KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line)","aka":[],"tldr":"A phase 2 trial of Imatinib in metastatic cancer, run by Kumquat Biosciences Inc., now recruiting.","summary":"KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line) is a phase 2 interventional study registered as NCT07406633 by Kumquat Biosciences Inc., with 46 participants planned, started 2026-06-23 and due to reach its primary completion in 2027-10. Interventions recorded: KQB198, Imatinib (Gleevec). Conditions listed: GIST - Gastrointestinal Stromal Tumor, GIST, GIST Metastatic Cancer, Gastro Intestinal Stromal Tumour. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07406633","url":"https://clinicaltrials.gov/study/NCT07406633"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["imatinib"],"companies":["kumquat-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07406633","phase":"2","setting":"A Phase 2, Multicenter, Study Evaluating the Efficacy, Safety, Tolerability, Pharmacokinetics of KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GI Stromal Tumor in 1st Line Setting","sponsor":"Kumquat Biosciences Inc.","started":"2026-06-23","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07353645","kind":"trial","name":"KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, now recruiting.","summary":"KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer is a phase 1/2, interventional study registered as NCT07353645 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, with a registry enrolment figure of 49 participants, started 2026-03-23 and due to reach its primary completion in 2029-01-01. Interventions recorded: KRAS Neoantigen Nanovaccine. Conditions listed: Colorectal Cancer; Pancreatic Cancer. Primary outcome: Dose-limiting toxicities (DLT). Pancreatic eligibility wording from the registry: \"* Patients with histologically confirmed colorectal adenocarcinoma or pancreatic adenocarcinoma who have undergone radical resection (R0) and completed at least 4 cycles of postoperative adjuvant chemotherapy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07353645","url":"https://clinicaltrials.gov/study/NCT07353645"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["neoantigen-mrna-vaccine"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07353645","phase":"1/2","setting":"Phase I/II Clinical Study of KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer With High Risk of Recurrence","sponsor":"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","started":"2026-03-23","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"krascendo-1","kind":"trial","name":"Krascendo 1","aka":[],"tldr":"The first head-to-head trial among KRAS drugs: Roche's divarasib beat the two approved pills on progression and survival.","summary":"Krascendo 1, trial NCT06497556 sponsored by Roche, is the first head-to-head trial among KRAS drugs, comparing divarasib with sotorasib or adagrasib in previously treated KRAS G12C-mutant non-small-cell lung cancer. Roche announced on 2 July 2026 that divarasib showed superior progression-free survival by blinded review and superior overall survival at an interim analysis against the two approved inhibitors, with full data expected at a 2026 congress from a trial of 338 patients. OnCo links it to KRAS as a target and to all three drugs, and notes that Krascendo 2 tests divarasib with pembrolizumab in the first line. Because the numbers are pending and this is the first such comparison, there is no independent replication, and whether a more potent G12C inhibitor changes the modest picture left by CodeBreaK 200 and KRYSTAL-12 is the open question. Divarasib has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT06497556","url":"https://clinicaltrials.gov/study/NCT06497556"},{"label":"Roche release","url":"https://www.roche.com/media/releases/med-cor-2026-07-02"}],"tags":[],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":["kras-inhibitors"],"targets":["kras"],"drugs":["divarasib","sotorasib","adagrasib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06497556","phase":"3","setting":"Previously treated KRAS G12C NSCLC: divarasib vs sotorasib or adagrasib","sponsor":"Roche","result":"Superior PFS and OS vs approved G12C inhibitors (topline, July 2026).","started":"2024-09-23","startedType":"actual","yearReported":2026,"enrolled":338,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Divarasib","note":"Primary endpoint met with a statistically significant, clinically meaningful improvement per the sponsor (topline 2 July 2026); medians and hazard ratio pending presentation."},{"name":"Sotorasib or adagrasib"}],"source":"https://clinicaltrials.gov/study/NCT06497556"},{"endpoint":"Overall survival (interim)","unit":"months","arms":[{"name":"Divarasib","note":"Statistically significant OS improvement at the interim analysis per the sponsor; numbers pending."},{"name":"Sotorasib or adagrasib"}],"source":"https://clinicaltrials.gov/study/NCT06497556"}],"replication":"Topline reported July 2026; numbers pending presentation. First head-to-head phase 3 among KRAS G12C inhibitors, so no independent replication yet."},{"id":"kristine","kind":"trial","name":"KRISTINE","aka":[],"tldr":"KRISTINE tested whether an antibody-drug conjugate could replace chemotherapy before surgery in HER2-positive breast cancer and found it could not: fewer tumours disappeared and more grew before the operation.","summary":"KRISTINE, trial NCT02131064 sponsored by Roche and Genentech and published in the Lancet Oncology in 2018, randomised 444 patients with stage II or III HER2-positive breast cancer to six cycles of trastuzumab emtansine plus pertuzumab or to docetaxel, carboplatin, trastuzumab and pertuzumab before surgery. Pathological complete response was 44.4 percent with the antibody-drug conjugate against 55.7 percent with chemotherapy, and although the conjugate arm had fewer severe side effects and better quality of life, 15 patients in that arm had locoregional progression before surgery against none with chemotherapy. The three-year follow-up in 2019 showed worse event-free survival with the conjugate driven by those pre-surgical progressions, while invasive disease-free survival after surgery was similar. The trial is the standard warning against replacing chemotherapy with an antibody-drug conjugate on the basis of response rates alone, a lesson revisited when DESTINY-Breast11 kept a chemotherapy phase after trastuzumab deruxtecan.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02131064","url":"https://clinicaltrials.gov/study/NCT02131064"},{"label":"Hurvitz et al., KRISTINE (Lancet Oncology 2018)","url":"https://doi.org/10.1016/S1470-2045(17)30716-7"}],"tags":["failure","lesson:selection"],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["adc"],"targets":["her2"],"drugs":["trastuzumab-emtansine","pertuzumab","docetaxel","carboplatin","trastuzumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["pcr"],"trials":[],"people":["sara-hurvitz"],"bottlenecks":[],"keyPapers":["paper-kristine-lancet-oncol-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02131064","phase":"3","setting":"Stage II to III HER2-positive breast cancer: neoadjuvant trastuzumab emtansine plus pertuzumab vs docetaxel, carboplatin, trastuzumab and pertuzumab","sponsor":"Roche / Genentech","result":"Pathological complete response 44.4% (T-DM1 + pertuzumab) vs 55.7% (TCHP); more locoregional progression before surgery with T-DM1.","started":"2014-06-25","startedType":"actual","yearReported":2018,"enrolled":444,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathological complete response (breast and axilla)","primary":true,"unit":"%","arms":[{"name":"Trastuzumab emtansine + pertuzumab","n":223,"value":44.4},{"name":"Docetaxel, carboplatin, trastuzumab, pertuzumab","n":221,"value":55.7}],"p":"0.016","source":"https://doi.org/10.1016/S1470-2045(17)30716-7"}],"replication":"The 2019 event-free survival update confirmed the disadvantage; DESTINY-Breast11 later stopped its trastuzumab deruxtecan monotherapy arm for lower efficacy."},{"id":"nct03669965","kind":"trial","name":"KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera","aka":[],"tldr":"A phase 2 trial of KRT-232 and Ruxolitinib in myeloproliferative neoplasms, run by Kartos Therapeutics, Inc., active and no longer recruiting.","summary":"KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera is a phase 2 interventional study registered as NCT03669965 by Kartos Therapeutics, Inc., with 20 participants enrolled, started 2019-01-15 and due to reach its primary completion in 2022-04. Interventions recorded: KRT-232 and Ruxolitinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03669965","url":"https://clinicaltrials.gov/study/NCT03669965"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["krt-232","ruxolitinib"],"companies":["kartos-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03669965","phase":"2","setting":"A Two-Part, Randomized, Open-label, Multicenter, Phase 2a/2b Study of the Efficacy, Safety, and Pharmacokinetics of KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera","sponsor":"Kartos Therapeutics, Inc.","started":"2019-01-15","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"krystal-12","kind":"trial","name":"KRYSTAL-12","aka":[],"tldr":"Confirmed that the KRAS pill adagrasib beats chemotherapy after first-line treatment, though the gain is modest.","summary":"KRYSTAL-12, trial NCT04685135 sponsored by Bristol Myers Squibb through Mirati and reported in 2024, confirmed that the KRAS G12C inhibitor adagrasib beats docetaxel after first-line treatment in KRAS G12C-mutant non-small-cell lung cancer, though the gain is modest. It randomised 453 patients, met its primary progression-free survival endpoint by blinded review and showed higher objective and intracranial response rates than chemotherapy, supporting full approval and the second-line role of G12C inhibitors, while overall survival was not yet significantly different. OnCo links it to KRAS as a target and to the bottleneck of undruggable drivers, and its result is consistent with CodeBreaK 200 for sotorasib, where neither trial showed a survival benefit. Whether G12C inhibitors help more in first-line combinations is the open question. Adagrasib has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT04685135","url":"https://clinicaltrials.gov/study/NCT04685135"}],"tags":[],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":["kras-inhibitors"],"targets":["kras"],"drugs":["adagrasib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-krystal-12-plain-language-summary-future-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04685135","phase":"3","setting":"Previously treated KRAS G12C NSCLC: adagrasib vs docetaxel","sponsor":"BMS (Mirati)","result":"PFS HR 0.58.","started":"2021-02-23","startedType":"actual","yearReported":2024,"enrolled":453,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Adagrasib","n":301,"value":5.5},{"name":"Docetaxel","n":152,"value":3.8}],"hr":0.58,"ci":[0.45,0.76],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT04685135"}],"replication":"Consistent with CodeBreaK 200 (sotorasib vs docetaxel, PFS HR 0.66); neither trial showed an OS benefit."},{"id":"nct06788756","kind":"trial","name":"L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Re","aka":[],"tldr":"A phase 2/3 trial of Cytarabine in acute myeloid leukaemia, run by Moleculin Biotech, Inc., now recruiting.","summary":"L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML is a phase 2/3 interventional study registered as NCT06788756 by Moleculin Biotech, Inc., with 312 participants planned, started 2025-03-12 and due to reach its primary completion in 2029-08. Interventions recorded: Placebo in combination with Cytarabine Injection, Liposomal Annamycin Injection in combination with Cytarabine Injection, Liposomal Annamycin Injection in combination with Cytarabine Injection, Liposomal Annamycin for Injection in combination with Cytarabine Injection.. Conditions listed: Acute Myeloid Leukaemia (AML). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06788756","url":"https://clinicaltrials.gov/study/NCT06788756"}],"tags":["ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cytarabine"],"companies":["moleculin"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06788756","phase":"2/3","setting":"A Pivotal Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of L Annamycin for Injection in Combination With Cytarabine Injection Versus Placebo in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed Acute Myeloid Leukemia","sponsor":"Moleculin Biotech, Inc.","started":"2025-03-12","startedType":"actual","enrolled":312,"enrolledBasis":"registry","outcomes":[]},{"id":"l-mind","kind":"trial","name":"L-MIND","aka":[],"tldr":"The small single-arm study that got tafasitamab approved for people too frail for transplant.","summary":"L-MIND, trial NCT02399085 sponsored by MorphoSys and reported in 2020, was the small single-arm study that got tafasitamab plus lenalidomide approved for people with relapsed or refractory diffuse large B-cell lymphoma who are too frail for transplant. In 81 enrolled patients with one to three prior lines the objective response rate was 60 percent with complete responses in 43 percent, responses were durable at five years, and the RE-MIND matched real-world comparison supported approval. OnCo links it to lymphoma, tafasitamab and lenalidomide. Whether a matched external comparison is an adequate basis for approval, and how the regimen ranks against bispecifics and CAR-T in the same patients, are the open questions.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02399085","url":"https://clinicaltrials.gov/study/NCT02399085"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["tafasitamab","lenalidomide"],"companies":["morphosys"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02399085","phase":"2","setting":"R/R DLBCL, transplant-ineligible, 1-3 prior lines: tafasitamab + lenalidomide (single arm)","sponsor":"MorphoSys","result":"ORR 60%, CR 43%.","started":"2016-03-29","startedType":"actual","yearReported":2020,"enrolled":81,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Tafasitamab + lenalidomide","n":80,"value":60}],"source":"https://doi.org/10.1016/S1470-2045(20)30225-4"}]},{"id":"nct07227350","kind":"trial","name":"L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)","aka":[],"tldr":"A phase 2 trial of L19IL2 in basal cell carcinoma, run by Philogen S.p.A., now recruiting.","summary":"L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC) is a phase 2 interventional study registered as NCT07227350 by Philogen S.p.A., with 180 participants planned, started 2026-06-01 and due to reach its primary completion in 2031-02. Interventions recorded: L19IL2, L19TNF and L19IL2/L19TNF.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07227350","url":"https://clinicaltrials.gov/study/NCT07227350"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["basal-cell-carcinoma","locally-advanced-bcc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["philogen-s-p-a"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07227350","phase":"2","setting":"A Phase 2 Controlled Randomized Study of the Efficacy of L19IL2 or L19TNF or L19IL2/L19TNF Intralesional Injections for the Treatment of Locally Advanced Basal Cell Carcinoma (LaBCC)","sponsor":"Philogen S.p.A.","started":"2026-06-01","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07227870","kind":"trial","name":"L19IL2/TNF in Patients With Basal Cell Carcinoma","aka":[],"tldr":"A phase 2 trial of L19IL2/L19TNF in basal cell carcinoma, run by Philogen S.p.A., now recruiting.","summary":"L19IL2/TNF in Patients With Basal Cell Carcinoma is a phase 2 interventional study registered as NCT07227870 by Philogen S.p.A., with 92 participants planned, started 2026-09 and due to reach its primary completion in 2031-02. Interventions recorded: L19IL2/L19TNF.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07227870","url":"https://clinicaltrials.gov/study/NCT07227870"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["basal-cell-carcinoma","locally-advanced-bcc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["philogen-s-p-a"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07227870","phase":"2","setting":"A Phase 2 Study of Intratumoral Administration of L19IL2/L19TNF in Locally Advanced Basal Cell Carcinoma Patients Progressing or Intolerant to Systemic Treatment.","sponsor":"Philogen S.p.A.","started":"2026-09","startedType":"estimated","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"lacc","kind":"trial","name":"LACC (Laparoscopic Approach to Cervical Cancer)","aka":[],"tldr":"Keyhole surgery, assumed equivalent, turned out to be worse: more recurrences and more deaths than open surgery, reversing practice overnight.","summary":"4.5-year disease-free survival 86.0% vs 96.5% and OS HR for death 6.00 with minimally invasive surgery (NEJM 2018); the final analysis (2024) confirmed inferiority. Guidelines now recommend open radical hysterectomy; tumour spillage from uterine manipulators and CO2 is the leading hypothesis. Trials of protective manoeuvres (RACC, ROCC) are ongoing.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00614211","url":"https://clinicaltrials.gov/study/NCT00614211"},{"label":"NEJM 2018","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1806395"}],"tags":["failure","lesson:surgical-technique"],"related":[],"cancers":["cervical","early-cervical-cancer"],"sections":[],"technologies":["robotic-surgery"],"targets":[],"drugs":[],"companies":[],"institutions":["md-anderson"],"pathways":[],"terms":[],"trials":[],"people":["pedro-ramirez"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00614211","phase":"3","setting":"Early-stage cervical cancer (IA1 with LVSI to IB1): minimally invasive vs open radical hysterectomy","sponsor":"MD Anderson","result":"4.5-year DFS 86.0% vs 96.5%; death HR 6.00 with MIS.","started":"2008-01","startedType":"actual","yearReported":2018,"enrolled":636,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 4.5 years","primary":true,"unit":"%","arms":[{"name":"Minimally invasive","n":319,"value":86},{"name":"Open surgery","n":312,"value":96.5}],"hr":3.74,"ci":[1.63,8.58],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1806395"},{"endpoint":"Overall survival at 3 years","unit":"%","arms":[{"name":"Minimally invasive","value":93.8},{"name":"Open surgery","value":99}],"hr":6,"ci":[1.77,20.3],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1806395"}],"replication":"Confirmed by the SEER/NCDB cohort (Melamed, NEJM 2018) and the SUCCOR European cohort."},{"id":"lace-pooled-analysis","kind":"trial","name":"LACE (Lung Adjuvant Cisplatin Evaluation) pooled analysis","aka":["LACE meta-analysis","Lung Adjuvant Cisplatin Evaluation"],"tldr":"Pooling five trials settled the question of who benefits from chemotherapy after lung cancer surgery: about five people in a hundred live longer at five years, and none of them has stage IA disease.","summary":"LACE pooled individual patient data on 4,584 patients from the five largest trials of cisplatin-based chemotherapy after complete resection conducted after the 1995 non-small-cell lung cancer meta-analysis. At a median 5.2 years, the overall hazard ratio for death was 0.89 (95 percent confidence interval 0.82 to 0.96, p=0.005), a 5.4 percent absolute five-year benefit, with no heterogeneity between trials.\n\nThe benefit varied by stage (test for trend p=0.04): stage IA hazard ratio 1.40 (0.95 to 2.06), stage IB 0.93 (0.78 to 1.10), stage II 0.83 (0.73 to 0.95) and stage III 0.83 (0.72 to 0.94). Chemotherapy in stage IA disease looked harmful, and it has not been offered since. The drug partner did not significantly change the effect, although vinorelbine gave the numerically best hazard ratio (0.80, 0.70 to 0.91) against etoposide or a vinca alkaloid (0.92) and other partners (0.97). Benefit was larger in patients with better performance status, and did not vary by sex, age, histology, type of surgery, planned radiotherapy or planned cisplatin dose.\n\nLACE is the reference that decides who is offered adjuvant chemotherapy today, and its stage gradient is the reason a 3 cm node-negative tumour is treated differently from a 5 cm one.","status":"positive","asOf":"2026-09-25","links":[{"label":"LACE pooled analysis (Journal of Clinical Oncology 2008)","url":"https://doi.org/10.1200/JCO.2007.13.9030"}],"tags":[],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin","vinorelbine","etoposide"],"companies":[],"institutions":[],"pathways":[],"terms":["performance-status"],"trials":["ialt","jbr-10","anita"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"observational","setting":"Individual patient data from the five largest trials of postoperative cisplatin-based chemotherapy in completely resected non-small-cell lung cancer, analysed for interactions between chemotherapy effect and stage, drug partner and performance status","sponsor":"LACE Collaborative Group","result":"Hazard ratio for death 0.89 (95 percent confidence interval 0.82 to 0.96), a 5.4 percent absolute five-year survival benefit; no benefit, and possible harm, in stage IA.","yearReported":2008,"enrolled":4584,"enrolledBasis":"analysed","enrolledNote":"Individual patient data on 4,584 patients from the five largest adjuvant cisplatin trials; it is a pooled analysis, not a trial with its own registration.","outcomes":[{"endpoint":"Overall survival, all stages","primary":true,"arms":[{"name":"Cisplatin-based adjuvant chemotherapy","n":4584,"note":"5.4 percent absolute five-year benefit"}],"hr":0.89,"ci":[0.82,0.96],"p":"0.005","source":"https://doi.org/10.1200/JCO.2007.13.9030"},{"endpoint":"Overall survival, stage IA","arms":[{"name":"Cisplatin-based adjuvant chemotherapy","note":"no benefit; point estimate favours observation"}],"hr":1.4,"ci":[0.95,2.06],"source":"https://doi.org/10.1200/JCO.2007.13.9030"},{"endpoint":"Overall survival, stage II","arms":[{"name":"Cisplatin-based adjuvant chemotherapy"}],"hr":0.83,"ci":[0.73,0.95],"source":"https://doi.org/10.1200/JCO.2007.13.9030"}]},{"id":"nct04250922","kind":"trial","name":"LAM561 With RT and TMZ for Adults With Glioblastoma","aka":["CLINGLIO"],"tldr":"A phase 2/3 trial testing LAM561 in glioma & glioblastoma, active and no longer recruiting.","summary":"LAM561 With RT and TMZ for Adults With Glioblastoma is a phase 2/3 interventional study registered as NCT04250922, led by Laminar Pharmaceuticals with Laboratory of America, Northern Institute for Cancer Research, Newcastle and Theradis pharma, and active but no longer recruiting on the registry. Official title: A Randomised, Double-blind, Placebo-controlled Adjuvant Trial in Newly Diagnosed Primary Glioblastoma Subjects to Assess the Efficacy and Safety of LAM561 in Combination With Radiotherapy and Temozolomide Standard of Care Treatment. Planned enrolment is 144 participants (actual). The study started in 2019-12-01 and primary completion is expected in 2026-01-15. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04250922","url":"https://clinicaltrials.gov/study/NCT04250922"}],"tags":["ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":["lam561"],"companies":["laminar-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04250922","phase":"2/3","setting":"A Randomized, Double-blind, Placebo-controlled Adjuvant Trial in Newly Diagnosed Primary Glioblastoma Subjects to Assess the Efficacy and Safety of LAM561 in Combination With Radiotherapy and Temozolomide Standard of Care Treatment","sponsor":"Laminar Pharmaceuticals","started":"2019-12-01","startedType":"actual","enrolled":144,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00383708","kind":"trial","name":"Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients","aka":[],"tldr":"A phase 3 trial of Somatostatin analogues and Pegvisomant in Pituitary tumours, run by Ipsen, completed.","summary":"Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients is a phase 3 interventional study registered as NCT00383708 by Ipsen, with 125 participants recorded, started 2006-10 and reaching its primary completion in 2008-10. Interventions recorded: lanreotide (Autogel formulation), Pegvisomant. Conditions recorded: Acromegaly.\n\nLinked to the drug Pegvisomant because the registry names it among its interventions and Pituitary tumours among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00383708","url":"https://clinicaltrials.gov/study/NCT00383708"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pituitary-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["octreotide-lanreotide","pegvisomant"],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00383708","phase":"3","setting":"Phase III, Multicentre, Open Study to Assess the Efficacy and Safety Profiles of the Co-administration of Lanreotide Autogel 120 mg (Administered Via Deep Subcutaneous Injections Every 28 Days) and Pegvisomant 40 to 120 mg Per Week (Administered Via Subcutaneous Route Once or Twice a Week) in Acromegalic Patients Failing to Respond to Lanreotide Autogel 120 mg Alone","sponsor":"Ipsen","started":"2006-10","yearReported":2018,"enrolled":125,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period","primary":true,"unit":"%","arms":[{"name":"Lanreotide Autogel + Pegvisomant Co-administration","n":57,"value":57.9,"note":"Figures from the ClinicalTrials.gov results section (first posted 2018-07-23), not from a publication"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT00383708?tab=results"}]},{"id":"nct06807437","kind":"trial","name":"Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula","aka":[],"tldr":"A phase 3 trial of somatostatin analogues (octreotide, lanreotide) in pancreatic cancer, run by SWOG Cancer Research Network, now recruiting.","summary":"Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula is a phase 3, randomised interventional study registered as NCT06807437 by SWOG Cancer Research Network, with a registry enrolment figure of 274 participants, started 2025-05-09 and due to reach its primary completion in 2027-11-01. Interventions recorded: Biospecimen Collection; Distal Pancreatectomy; Lanreotide; Questionnaire Administration; Saline. Conditions listed: Pancreatic Carcinoma; Pancreatic Neoplasm. Primary outcome: Incidence of postoperative pancreatic fistula (POPF). Pancreatic eligibility wording from the registry: \"* Participants must have histologically or radiographically confirmed diagnosis of pancreatic cancer or a pancreatic lesion with malignant potential\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06807437","url":"https://clinicaltrials.gov/study/NCT06807437"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["octreotide-lanreotide"],"companies":["swog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06807437","phase":"3","setting":"A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula","sponsor":"SWOG Cancer Research Network","started":"2025-05-09","startedType":"actual","enrolled":274,"enrolledBasis":"registry","outcomes":[]},{"id":"lap07","kind":"trial","name":"LAP07","aka":["LAP 07","GERCOR LAP07"],"tldr":"LAP07 tested whether adding radiotherapy after four months of chemotherapy helps people whose pancreatic cancer has not spread but cannot be removed; it did not lengthen life, although it did keep the tumour in check locally for longer, and adding erlotinib to gemcitabine did not help either.","summary":"LAP07 was an international open-label phase 3 trial run by GERCOR in 449 patients with locally advanced pancreatic cancer. Patients were first randomised to gemcitabine or gemcitabine with erlotinib for four months; the 269 whose disease was controlled were then randomised to capecitabine-based chemoradiotherapy or two more months of the same chemotherapy. The primary endpoint was overall survival.\n\nThe trial stopped for futility at the interim analysis: median overall survival was 16.5 months with chemotherapy and 15.2 months with chemoradiotherapy (hazard ratio 1.03), and 13.6 months with gemcitabine against 11.9 months with gemcitabine plus erlotinib (hazard ratio 1.19). Chemoradiotherapy did reduce local progression (32 against 46 percent) without more grade 3 to 4 toxicity except nausea. The corpus's locally advanced pancreatic cancer page cites LAP07 for better local control without longer survival.","status":"negative","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00634725","url":"https://clinicaltrials.gov/study/NCT00634725"}],"tags":["soc-trials"],"related":[],"cancers":["locally-advanced-pdac","pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","kinase-inhibitors"],"targets":[],"drugs":["gemcitabine","erlotinib","capecitabine"],"companies":["gercor"],"institutions":[],"pathways":[],"terms":["pancreatic-failed-programmes"],"trials":["conko-007","scalop","crossfire"],"people":[],"bottlenecks":[],"keyPapers":["paper-lap07-chemoradiotherapy-locally-advanced-pancreatic-jama-2016"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00634725","phase":"3","setting":"Locally advanced unresectable pancreatic cancer: a first randomisation to four months of gemcitabine with or without erlotinib, then for patients without progression a second randomisation to capecitabine-based chemoradiotherapy (54 Gy) or two further months of chemotherapy","sponsor":"GERCOR - Multidisciplinary Oncology Cooperative Group","result":"Median overall survival 15.2 months with chemoradiotherapy against 16.5 months with chemotherapy alone (hazard ratio 1.03, p 0.83); local progression 32 against 46 percent; erlotinib added nothing (13.6 against 11.9 months, hazard ratio 1.19).","started":"2008-02","yearReported":2016,"enrolled":449,"enrolledBasis":"registered","enrolledNote":"The registry gives an estimated 820; the JAMA report enrolled 449 patients, 442 of whom had the first randomisation and 269 the second.","outcomes":[{"endpoint":"Overall survival from first randomisation, chemoradiotherapy against chemotherapy (second randomisation)","primary":true,"unit":"months","arms":[{"name":"Capecitabine-based chemoradiotherapy after 4 months of chemotherapy","value":15.2,"note":"95% CI 13.9 to 17.3; 269 patients in the second randomisation"},{"name":"Two further months of chemotherapy","value":16.5,"note":"95% CI 14.5 to 18.5"}],"hr":1.03,"ci":[0.79,1.34],"p":"0.83","source":"https://doi.org/10.1001/jama.2016.4324"},{"endpoint":"Overall survival, gemcitabine against gemcitabine plus erlotinib (first randomisation)","unit":"months","arms":[{"name":"Gemcitabine","n":223,"value":13.6,"note":"95% CI 12.3 to 15.3"},{"name":"Gemcitabine + erlotinib","n":219,"value":11.9,"note":"95% CI 10.4 to 13.5"}],"hr":1.19,"ci":[0.97,1.45],"p":"0.09","source":"https://doi.org/10.1001/jama.2016.4324"},{"endpoint":"Local progression","unit":"%","arms":[{"name":"Capecitabine-based chemoradiotherapy","value":32},{"name":"Chemotherapy alone","value":46}],"p":"0.03","source":"https://doi.org/10.1001/jama.2016.4324"}]},{"id":"lapis-trial","kind":"trial","name":"LAPIS","aka":[],"tldr":"The anti-stroma antibody pamrevlumab did not help people with locally advanced pancreatic cancer live longer.","summary":"LAPIS randomised patients with locally advanced, unresectable pancreatic ductal adenocarcinoma to pamrevlumab or placebo with either gemcitabine plus nab-paclitaxel or FOLFIRINOX, with the aim of increasing resection and survival. FibroGen reported in 2024 that the trial did not meet its primary overall survival endpoint.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03941093","url":"https://clinicaltrials.gov/study/NCT03941093"}],"tags":[],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["pamrevlumab","gemcitabine-nab-paclitaxel","folfirinox"],"companies":["fibrogen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03941093","phase":"3","setting":"Locally advanced unresectable pancreatic cancer: pamrevlumab with gemcitabine and nab-paclitaxel or FOLFIRINOX versus chemotherapy alone","sponsor":"FibroGen","result":"Primary overall survival endpoint not met.","started":"2019-05-10","startedType":"actual","yearReported":2024,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Pamrevlumab + chemotherapy (gemcitabine-nab-paclitaxel or FOLFIRINOX)","n":143,"value":17.25},{"name":"Placebo + chemotherapy","n":141,"value":17.94}],"hr":1.08,"ci":[0.83,1.41],"p":"0.5487","source":"https://clinicaltrials.gov/study/NCT03941093"},{"endpoint":"Progression-free survival (RECIST 1.1)","unit":"months","arms":[{"name":"Pamrevlumab + chemotherapy","n":143,"value":9.36},{"name":"Placebo + chemotherapy","n":141,"value":9.4}],"source":"https://clinicaltrials.gov/study/NCT03941093"}]},{"id":"nct07620548","kind":"trial","name":"Laser Interstitial Thermal Therapy (LiTT) With Cemiplimab or Other Chemotherapy in Recurrent Glioblastomas","aka":[],"tldr":"A phase 2 trial of Laser interstitial thermal therapy systems in Glioma & glioblastoma, run by Washington University School of Medicine, not yet recruiting.","summary":"Laser Interstitial Thermal Therapy (LiTT) With Cemiplimab or Other Chemotherapy in Recurrent Glioblastomas is a phase 2 interventional study registered as NCT07620548 by Washington University School of Medicine, with 99 participants planned, started 2026-08-31 and due to reach its primary completion in 2031-02-28. Interventions recorded: NeuroBlate® Laser Ablation Laser Interstitial Thermal Therapy, Cemiplimab, Chemotherapy. Conditions recorded: Glioblastoma, Glioblastoma, IDH-wildtype, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype.\n\nLinked to the technology Laser interstitial thermal therapy systems because the registry names it (\"neuroblate\") among its interventions and Glioma & glioblastoma among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07620548","url":"https://clinicaltrials.gov/study/NCT07620548"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["litt-systems"],"targets":[],"drugs":["cemiplimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07620548","phase":"2","setting":"A Randomized Phase II Study of the Efficacy of Laser Interstitial Thermal Therapy (LiTT) Combined With Cemiplimab Versus Physician's Choice Chemotherapy in Recurrent Glioblastomas","sponsor":"Washington University School of Medicine","started":"2026-08-31","startedType":"estimated","enrolled":99,"enrolledBasis":"registry","outcomes":[]},{"id":"latitude","kind":"trial","name":"LATITUDE","aka":[],"tldr":"LATITUDE established abiraterone at first metastatic diagnosis for high-risk disease.","summary":"LATITUDE, trial NCT01715285 sponsored by Janssen and reported in 2017, established abiraterone at first metastatic diagnosis for men with high-risk de novo metastatic hormone-sensitive prostate cancer. It randomised 1,199 men to androgen deprivation with abiraterone or placebo and met its primary overall survival endpoint, confirmed at the final analysis. OnCo links it to prostate cancer, abiraterone acetate, Karim Fizazi and the terms for androgen receptor pathway inhibitors and for hormone-sensitive versus castration-resistant disease, and the result was replicated by arm G of the STAMPEDE platform in a broader population. Whether abiraterone should be combined with docetaxel as a triplet, as PEACE-1 later tested, or used alone, is the question that followed from it. Abiraterone acetate has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT01715285","url":"https://clinicaltrials.gov/study/NCT01715285"},{"label":"NICE TA1110: abiraterone (originator and generics) for treating newly diagnosed high-risk hormone-sensitive metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta1110"},{"label":"NICE TA721: abiraterone for treating newly diagnosed high-risk hormone-sensitive metastatic prostate cancer, replaced by TA1110","url":"https://www.nice.org.uk/guidance/ta721"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["abiraterone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["prostate-uk-drug-approvals"],"trials":["stampede","nct02489318"],"people":["karim-fizazi"],"bottlenecks":[],"keyPapers":["paper-latitude-nejm-2017","paper-latitude-lancet-oncol-2019-update"],"journals":[],"dependsOn":[],"notes":["LATITUDE and the STAMPEDE abiraterone comparison were published within days of each other in 2017 and together moved abiraterone to first diagnosis of metastatic disease. In England the appraisal that covered this indication, NICE TA721 of 18 August 2021, said abiraterone with prednisone or prednisolone plus androgen deprivation was not recommended. It has been replaced by NICE TA1110 of 19 November 2025, which recommends abiraterone (originator and generics) plus androgen deprivation with prednisolone or prednisone within its marketing authorisation for newly diagnosed high-risk hormone-sensitive metastatic prostate cancer, so England went from a refusal to routine funding within 30 days of that publication. The evaluation notes that usual treatment in the NHS for this population is enzalutamide plus androgen deprivation or apalutamide plus androgen deprivation, and that abiraterone works in a similar way and would be offered to the same men."],"nct":"NCT01715285","phase":"3","setting":"High-risk de novo metastatic hormone-sensitive prostate cancer: ADT + abiraterone vs ADT","sponsor":"Janssen","result":"OS HR 0.66.","started":"2013-02-12","startedType":"actual","yearReported":2017,"enrolled":1209,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"ADT + abiraterone","n":597,"value":53.3},{"name":"ADT + placebo","n":602,"value":36.5}],"hr":0.66,"ci":[0.56,0.78],"p":"<0.0001","source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30082-8/fulltext"}],"replication":"Replicated by STAMPEDE arm G."},{"id":"laura","kind":"trial","name":"LAURA","aka":[],"tldr":"For stage III lung cancers with an EGFR mutation, a targeted pill after chemoradiation cut progression by more than 80%.","summary":"LAURA, trial NCT03521154 sponsored by AstraZeneca and reported in 2024, showed that for unresectable stage III EGFR-mutant non-small-cell lung cancer, osimertinib after chemoradiation cuts the risk of progression by more than eighty percent compared with placebo. It enrolled 216 patients, met its primary progression-free survival endpoint by blinded review with a very large effect, and led to FDA approval in September 2024, replacing durvalumab consolidation in EGFR-mutant stage III disease. OnCo links it to EGFR as a target and to osimertinib, and the result is consistent with ADAURA in showing a large EGFR inhibitor benefit after local therapy. Overall survival is immature, the trial has no independent replication, and whether indefinite osimertinib is needed or a fixed course would do is the open question. Osimertinib has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT03521154","url":"https://clinicaltrials.gov/study/NCT03521154"}],"tags":[],"related":[],"cancers":["nsclc","egfr-mutant-nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["egfr"],"drugs":["osimertinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-lu-laura-osimertinib-stage-iii-nejm-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03521154","phase":"3","setting":"Unresectable stage III EGFR-mutant NSCLC after chemoradiation: osimertinib until progression vs placebo","sponsor":"AstraZeneca","result":"PFS HR 0.16.","started":"2018-07-19","startedType":"actual","yearReported":2024,"enrolled":216,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Osimertinib","n":143,"value":39.1},{"name":"Placebo","n":73,"value":5.6}],"hr":0.16,"ci":[0.1,0.24],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2402614"}],"replication":"Single pivotal trial; consistent with ADAURA in showing large EGFR-TKI benefit after local therapy. OS immature."},{"id":"lch-iii","kind":"trial","name":"LCH-III","aka":[],"tldr":"The Histiocyte Society's third international trial showed that treating multisystem Langerhans cell histiocytosis for a full year, rather than six months, roughly halves the chance of the disease coming back, while adding methotrexate added nothing but toxicity.","summary":"International randomised trial (Gadner et al., Blood 2013), more than 400 patients randomised. In risk-organ-positive disease, adding methotrexate to vinblastine and prednisone did not change response, survival or reactivation; but 12 months of therapy gave 5-year survival of 84% against 62% and 69% in the identically stratified predecessor trials LCH-I and LCH-II, and reduced 5-year reactivation to 27% from 55% and 44%. In risk-organ-negative disease, 12 months of vinblastine-prednisone lowered 5-year reactivation to 37% versus 54% with 6 months (P = 0.03). One year of vinblastine-prednisone became the international standard and the backbone of LCH-IV, which tests further prolongation and the addition of 6-mercaptopurine. The trial predates the discovery that most LCH carries BRAF V600E or other MAPK mutations, which now drive targeted therapy for refractory disease.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT00276757","url":"https://clinicaltrials.gov/study/NCT00276757"},{"label":"Gadner et al., Blood 2013","url":"https://doi.org/10.1182/blood-2012-09-455774"},{"label":"Histiocyte Society: LCH-IV","url":"https://histiocytesociety.org/LCH-IV"}],"tags":["nci-coverage","paediatric","histiocytosis"],"related":[],"cancers":["langerhans-cell-histiocytosis","lch-multisystem","lch-single-system"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":["braf"],"drugs":["vinblastine","methotrexate"],"companies":[],"institutions":["histiocyte-society"],"pathways":["ras-mapk"],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00276757","phase":"3","setting":"Multisystem Langerhans cell histiocytosis in children: risk-organ-positive patients randomised to vinblastine-prednisone with or without methotrexate (12 months total); risk-organ-negative responders randomised to 6 vs 12 months of vinblastine-prednisone","sponsor":"Histiocyte Society","result":"12 vs 6 months of vinblastine-prednisone: 5-year reactivation 37% vs 54% in risk-organ-negative disease; methotrexate added no benefit.","started":"2001-04","yearReported":2013,"enrolled":376,"enrolledBasis":"registry","outcomes":[{"endpoint":"5-year reactivation rate, risk-organ-negative","primary":true,"unit":"%","arms":[{"name":"12 months vinblastine-prednisone","value":37},{"name":"6 months vinblastine-prednisone","value":54}],"p":"0.03","source":"https://doi.org/10.1182/blood-2012-09-455774"},{"endpoint":"5-year reactivation rate, risk-organ-positive (both arms, 12 months)","unit":"%","arms":[{"name":"LCH-III","value":27},{"name":"LCH-I (historical, 6 months)","value":55},{"name":"LCH-II (historical, 6 months)","value":44}],"source":"https://doi.org/10.1182/blood-2012-09-455774"}],"replication":"Historical comparison with LCH-I and LCH-II for the risk-organ-positive stratum; LCH-IV (NCT02205762) is testing 12 vs 24 months."},{"id":"nct02205762","kind":"trial","name":"LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis","aka":[],"tldr":"A phase 2/3 trial of Prednisone, Vinblastine, Mercaptopurine, Methotrexate, Cytarabine, Cladribine and Human normal immunoglobulin in Langerhans cell histiocytosis, run by North American Consortium for Histiocytosis, active and no longer recruiting.","summary":"LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis is a phase 2/3 interventional study registered as NCT02205762 by North American Consortium for Histiocytosis, with 1400 participants planned, started 2016-11-02 and due to reach its primary completion in 2026-07. Interventions recorded: Prednisone, Vinblastine, mercaptopurine, INDOMETHACIN, Methotrexate, Cytosine Arabinoside, 2-chlorodeoxyadenosine, hematopoietic stem cell transplantation (RIC-HSCT), Intravenous immunoglobulin. Conditions recorded: Langerhans Cell Histiocytosis.\n\nLinked to the drug Human normal immunoglobulin because the registry names it among its interventions and Langerhans cell histiocytosis among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02205762","url":"https://clinicaltrials.gov/study/NCT02205762"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["langerhans-cell-histiocytosis"],"sections":[],"technologies":[],"targets":[],"drugs":["prednisone","vinblastine","mercaptopurine","methotrexate","cytarabine","cladribine","human-normal-immunoglobulin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02205762","phase":"2/3","setting":"LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis","sponsor":"North American Consortium for Histiocytosis","started":"2016-11-02","enrolled":1400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01828112","kind":"trial","name":"LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib","aka":[],"tldr":"A phase 3 trial of Ceritinib, Pemetrexed and Docetaxel in Non-small-cell lung cancer, run by Novartis Pharmaceuticals, completed.","summary":"LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib is a phase 3 interventional study registered as NCT01828112 by Novartis Pharmaceuticals, with 231 participants recorded, started 2013-06-28 and reaching its primary completion in 2016-01-26. Interventions recorded: Ceritinib, Pemetrexed, Docetaxel. Conditions recorded: Non-Small Cell Lung Cancer.\n\nLinked to the drug Ceritinib because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01828112","url":"https://clinicaltrials.gov/study/NCT01828112"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","alk-positive-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ceritinib","pemetrexed","docetaxel"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01828112","phase":"3","setting":"A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib","sponsor":"Novartis Pharmaceuticals","started":"2013-06-28","startedType":"actual","yearReported":2017,"enrolled":231,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) Per Blinded Independent Review Committee (BIRC)","primary":true,"unit":"months","arms":[{"name":"Ceritinib","n":115,"value":5.4,"note":"95% CI 4.1 to 6.9; Figures from the ClinicalTrials.gov results section (first posted 2017-07-27), not from a publication"},{"name":"Chemotherapy","n":116,"value":1.6,"note":"95% CI 1.4 to 2.8"}],"hr":0.49,"ci":[0.36,0.67],"p":"<0.001","source":"https://clinicaltrials.gov/study/NCT01828112?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Ceritinib","n":115,"value":17.7,"note":"95% CI 14.2 to 23.7; Figures from the ClinicalTrials.gov results section (first posted 2017-07-27), not from a publication"},{"name":"Chemotherapy","n":116,"value":20.1,"note":"95% CI 11.9 to 31.2"}],"source":"https://clinicaltrials.gov/study/NCT01828112?tab=results"},{"endpoint":"Overall Response Rate (ORR) Per BIRC","unit":"%","arms":[{"name":"Ceritinib","n":115,"value":40.9,"note":"95% CI 31.8 to 50.4; Figures from the ClinicalTrials.gov results section (first posted 2017-07-27), not from a publication"},{"name":"Chemotherapy","n":116,"value":6.9,"note":"95% CI 3.0 to 13.1"}],"source":"https://clinicaltrials.gov/study/NCT01828112?tab=results"}]},{"id":"nct07312422","kind":"trial","name":"LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study","aka":[],"tldr":"A phase 1/2 trial of pucotenlimab and gemcitabine + nab-paclitaxel in pancreatic cancer, run by Zhejiang Provincial People's Hospital, now recruiting.","summary":"LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study is a phase 1/2, interventional study registered as NCT07312422 by Zhejiang Provincial People's Hospital, with a registry enrolment figure of 10 participants, started 2025-09-30 and due to reach its primary completion in 2026-04-30. Interventions recorded: Low-dose Radiotherapy; Pucotenlimab; AG regimen; FOLFIRINOX regimen. Conditions listed: Pancreatic Cancer; PD-L1; PD-1 Inhibitor; LDRT; Proterizumab. Primary outcome: ORR. Pancreatic eligibility wording from the registry: \"* Patients with histologically or cytologically confirmed pancreatic malignancy;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07312422","url":"https://clinicaltrials.gov/study/NCT07312422"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["pucotenlimab","gemcitabine-nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07312422","phase":"1/2","setting":"An Open-label, Single-center, Single-arm Study to Evaluate the Efficacy and Safety of Low-dose Radiation Therapy Combined With Pultelimab and Standard Treatment in Patients With Advanced Pancreatic Cancer","sponsor":"Zhejiang Provincial People's Hospital","started":"2025-09-30","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06710756","kind":"trial","name":"Lead-212 PSV359 Therapy for Patients With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of [203Pb]Pb-PSV359 in pancreatic ductal adenocarcinoma, gastric & gastro-oesophageal junction cancer, oesophageal cancer, colorectal cancer, ovarian cancer and head and neck squamous cell carcinoma, run by Perspective Therapeutics, now recruiting.","summary":"Lead-212 PSV359 Therapy for Patients With Solid Tumors is a phase 1/2 interventional study registered as NCT06710756 by Perspective Therapeutics, with 112 participants planned, started 2025-04-28 and due to reach its primary completion in 2028-01-31. Interventions recorded: [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06710756","url":"https://clinicaltrials.gov/study/NCT06710756"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","gastric","esophageal","colorectal","ovarian","head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["perspective-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06710756","phase":"1/2","setting":"A Phase I/IIa Image-Guided, Alpha-Particle Therapy Study of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in Patients With Solid Tumors That Are Known to be Fibroblast Activation Protein (FAP)-Positive","sponsor":"Perspective Therapeutics","started":"2025-04-28","startedType":"actual","enrolled":112,"enrolledBasis":"registry","outcomes":[]},{"id":"leap-002","kind":"trial","name":"LEAP-002","aka":[],"tldr":"LEAP-002 randomised 794 patients with untreated advanced liver cancer to lenvatinib with or without pembrolizumab. Adding the immunotherapy did not lengthen life beyond lenvatinib alone, partly because the control arm did unusually well, a reminder that not every immunotherapy plus anti-angiogenic pairing works.","summary":"LEAP-002, trial NCT03713593 sponsored by Merck and Eisai and reported in 2022, found that adding pembrolizumab to lenvatinib did not extend life to a statistically significant degree in first-line unresectable hepatocellular carcinoma, a reminder that not every immunotherapy plus anti-angiogenic pairing works. It randomised 794 patients, and overall survival missed the prespecified boundary while progression-free survival was also not significant, with the lenvatinib control arm performing unusually well. OnCo links it to hepatocellular carcinoma, lenvatinib and pembrolizumab. Whether the failure reflects a strong comparator, the choice of PD-1 rather than PD-L1 blockade, or simple chance is the open question the trial left.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03713593","url":"https://clinicaltrials.gov/study/NCT03713593"}],"tags":["failure","lesson:control-arm"],"related":[],"cancers":["hcc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["lenvatinib","pembrolizumab"],"companies":["eisai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03713593","phase":"3","setting":"First-line unresectable HCC: lenvatinib + pembrolizumab vs lenvatinib","sponsor":"Merck / Eisai","result":"OS HR 0.84, not significant.","started":"2018-12-31","startedType":"actual","yearReported":2022,"enrolled":794,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Lenvatinib + pembrolizumab","n":395,"value":21.2},{"name":"Lenvatinib","n":399,"value":19}],"hr":0.84,"ci":[0.71,1],"source":"https://doi.org/10.1016/S1470-2045(23)00469-2"}]},{"id":"leap-012","kind":"trial","name":"LEAP-012","aka":[],"tldr":"Adding lenvatinib and pembrolizumab to TACE delayed progression by four and a half months but did not help patients live longer.","summary":"LEAP-012, trial NCT04246177 sponsored by Merck and Eisai and reported in 2024, found that adding lenvatinib and pembrolizumab to transarterial chemoembolisation for unresectable non-metastatic hepatocellular carcinoma delayed progression by about four and a half months but did not help patients live longer. It randomised 480 patients and met its primary progression-free survival endpoint, but grade 3 or worse adverse events were far more common and the final overall survival analysis in 2026 showed no difference. OnCo links it to TACE, lenvatinib, pembrolizumab and the pairing of TACE with immunotherapy and anti-VEGF drugs. The record calls it the clearest demonstration that progression-free survival is a poor surrogate in TACE combination trials, and whether regulators should accept that endpoint in this setting is the open question.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04246177","url":"https://clinicaltrials.gov/study/NCT04246177"},{"label":"Lancet","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02575-3/abstract"}],"tags":["lesson:surrogate-endpoint"],"related":[],"cancers":["hcc","hcc-intermediate"],"sections":[],"technologies":["tace"],"targets":[],"drugs":["lenvatinib","pembrolizumab"],"companies":["eisai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04246177","phase":"3","setting":"Unresectable non-metastatic HCC: TACE + lenvatinib + pembrolizumab vs TACE + placebo","sponsor":"Merck / Eisai","result":"PFS HR 0.66; final OS HR 0.98.","started":"2020-05-22","startedType":"actual","yearReported":2024,"enrolled":480,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"TACE + lenvatinib + pembrolizumab","value":14.6},{"name":"TACE + placebo","value":10}],"hr":0.66,"p":"0.0002"},{"endpoint":"Overall survival (final)","primary":true,"arms":[{"name":"TACE + lenvatinib + pembrolizumab"},{"name":"TACE + placebo"}],"hr":0.98}]},{"id":"nct06229340","kind":"trial","name":"Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations","aka":["NТО-RAS"],"tldr":"A phase 2 trial in pancreatic cancer, run by N.N. Petrov National Medical Research Center of Oncology, now recruiting.","summary":"Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations is a phase 2, interventional study registered as NCT06229340 by N.N. Petrov National Medical Research Center of Oncology, with a registry enrolment figure of 20 participants, started 2023-10-03 and due to reach its primary completion in 2026-10-01. Interventions recorded: Leflunomide; The combination of MEK inhibitor + hydroxychloroquine( plaquenil) ± bevacizumab. Conditions listed: RAS Mutation; Ras (Kras or Nras) Gene Mutation; Colorectal Cancer Recurrent; Pancreas Cancer; Lung Cancer; Melanoma; Refractory Cancer. Primary outcome: Objective response rate. Sites: Russia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06229340","url":"https://clinicaltrials.gov/study/NCT06229340"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06229340","phase":"2","setting":"New Therapeutic Approaches for Tumors With RAS Gene Mutations","sponsor":"N.N. Petrov National Medical Research Center of Oncology","started":"2023-10-03","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04752722","kind":"trial","name":"LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve","aka":["LEGEND"],"tldr":"A phase 1/2 trial of EG-70 (phase 1) in bladder & urothelial cancer, run by enGene, Inc., now recruiting.","summary":"LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve is a phase 1/2 interventional study registered as NCT04752722 by enGene, Inc., with 350 participants planned, started 2021-04-22 and due to reach its primary completion in 2028-04-30. Interventions recorded: EG-70 (phase 1), EG-70 (phase 2) Master Protocol and Surfactant Bladder Pre-Rinse and EG-70 (Substudy).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04752722","url":"https://clinicaltrials.gov/study/NCT04752722"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04752722","phase":"1/2","setting":"A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients With BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) and High-Risk NMIBC Patients Who Are BCG Naïve or Received Incomplete BCG Treatment","sponsor":"enGene, Inc.","started":"2021-04-22","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"legend-2","kind":"trial","name":"LEGEND-2","aka":[],"tldr":"The small Chinese trial whose startling response rates at ASCO 2017 drew Johnson and Johnson to Legend Biotech and became the myeloma CAR-T Carvykti.","summary":"57 patients treated at Xi'an Jiaotong University's Second Affiliated Hospital (Journal of Hematology and Oncology 2018): objective response 88%, complete response 68%, median progression-free survival 15 months, manageable cytokine release syndrome; a further 17 patients were treated at three other sites. Presented at ASCO 2017 by Fan Xiaohu and Zhao Wanhong, it led to the December 2017 Janssen collaboration ($350 million upfront) and to CARTITUDE-1, FDA approval as ciltacabtagene autoleucel in 2022 and NMPA approval in 2024. The clearest case of a Chinese academic-industry cell therapy becoming a global standard.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03090659","url":"https://clinicaltrials.gov/study/NCT03090659"},{"label":"J Hematol Oncol 2018","url":"https://doi.org/10.1186/s13045-018-0681-6"}],"tags":["china"],"related":["cartitude-1","cartitude-4"],"cancers":["multiple-myeloma"],"sections":[],"technologies":["car-t"],"targets":["bcma"],"drugs":["ciltacabtagene-autoleucel"],"companies":["legend-biotech","johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["zhang-fangliang"],"bottlenecks":[],"keyPapers":["paper-zhao-j-hematol-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03090659","phase":"1/2","setting":"Relapsed or refractory multiple myeloma, four hospitals in China: LCAR-B38M, a BCMA CAR-T with two llama-derived binding domains","sponsor":"Legend Biotech with Xi'an Jiaotong University and other Chinese hospitals","result":"ORR 88%, CR 68%, median PFS 15 months (Xi'an cohort, n = 57).","started":"2015-10-02","startedType":"actual","yearReported":2017,"enrolled":57,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"LCAR-B38M","n":57,"value":88}],"source":"https://doi.org/10.1186/s13045-018-0681-6"}]},{"id":"nct05170438","kind":"trial","name":"Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment","aka":["LenPac"],"tldr":"A phase 2 trial of gemcitabine, paclitaxel and lenvatinib in gallbladder cancer and other biliary tract cancers, run by National Health Research Institutes, Taiwan, active and no longer recruiting.","summary":"Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment is a phase 2 interventional study registered as NCT05170438 by National Health Research Institutes, Taiwan, with a registry enrolment figure of 51 participants, started 2022-07-01 and due to reach its primary completion in 2028-06. Interventions recorded: Lenvatinib Pill,Paclitaxel. Conditions listed: Advanced Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: \"* 2.Histologically confirmed biliary tract cancer which is locally advanced, recurrent or metastatic disease. The disease entities include intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, distal bile duct c\". Sites: Taiwan. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05170438","url":"https://clinicaltrials.gov/study/NCT05170438"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["gemcitabine","paclitaxel","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05170438","phase":"2","setting":"Phase II Trial of Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment","sponsor":"National Health Research Institutes, Taiwan","started":"2022-07-01","startedType":"actual","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04592653","kind":"trial","name":"Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3)","aka":["ARTISTRY-3"],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by Mural Oncology, Inc, active and no longer recruiting.","summary":"Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3) is a phase 1/2 interventional study registered as NCT04592653 by Mural Oncology, Inc, with 78 participants enrolled, started 2020-09-30 and due to reach its primary completion in 2024-07. Interventions recorded: Nemvaleukin alfa and Pembrolizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04592653","url":"https://clinicaltrials.gov/study/NCT04592653"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04592653","phase":"1/2","setting":"Clinical and Immunologic Activity of Nemvaleukin Alfa With Less Frequent IV Dosing Schedule as Monotherapy and in Combination With Pembrolizumab and Impact on Tumor Microenvironment in Solid Tumor Patients - ARTISTRY-3","sponsor":"Mural Oncology, Inc","started":"2020-09-30","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06193902","kind":"trial","name":"LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.","aka":["AERIAL"],"tldr":"A phase 1/2 trial of LEU011 in advanced solid tumours, run by Leucid Bio, now recruiting.","summary":"LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours. is a phase 1/2 interventional study registered as NCT06193902 by Leucid Bio, with 17 participants planned, started 2023-11-13 and due to reach its primary completion in 2029-05. Interventions recorded: LEU011.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06193902","url":"https://clinicaltrials.gov/study/NCT06193902"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06193902","phase":"1/2","setting":"A Phase I/IIa Open-label Dose Escalation Trial Evaluating the Safety and Preliminary Efficacy of LEU011 in Subjects With Relapsed/Refractory Solid Tumours","sponsor":"Leucid Bio","started":"2023-11-13","startedType":"actual","enrolled":17,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02159066","kind":"trial","name":"LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma","aka":[],"tldr":"A phase 2 trial of Infigratinib and Capmatinib in Melanoma, run by Pfizer, completed.","summary":"LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma is a phase 2 interventional study registered as NCT02159066 by Pfizer, with 158 participants recorded, started 2014-07-23 and reaching its primary completion in 2023-01-10. Interventions recorded: LGX818, MEK162, LEE011, BGJ398, BKM120, INC280. Conditions recorded: Melanoma.\n\nLinked to the drug Infigratinib because the registry names it among its interventions and Melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02159066","url":"https://clinicaltrials.gov/study/NCT02159066"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma","braf-v600-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["infigratinib","capmatinib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02159066","phase":"2","setting":"The LOGIC 2 Trial A Phase II, Multi-center, Open-label Study of Sequential LGX818/MEK162 Combination Followed by a Rational Combination With Targeted Agents After Progression, to Overcome Resistance in Adult Patients With Locally Advanced or Metastatic BRAF V600 Melanoma.","sponsor":"Pfizer","started":"2014-07-23","startedType":"actual","yearReported":2024,"enrolled":158,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Response Rate (ORR): Part II","primary":true,"unit":"%","arms":[{"name":"Part II: Encorafenib + Binimetinib + Ribociclib","n":38,"value":2.6,"note":"95% CI 0.1 to 13.8; Figures from the ClinicalTrials.gov results section (first posted 2024-03-05), not from a publication"},{"name":"Part II: Encorafenib + Binimetinib + Infigratinib","n":1,"value":0,"note":"95% CI NA to NA"},{"name":"Part II: Encorafenib + Binimetinib + Capmatinib","n":13,"value":0,"note":"95% CI 0.0 to 24.7"},{"name":"Part II: Encorafenib + Binimetinib + Buparlisib","n":6,"value":0,"note":"95% CI 0.0 to 45.9"}],"source":"https://clinicaltrials.gov/study/NCT02159066?tab=results"},{"endpoint":"Overall Survival (OS): Part II","unit":"months","arms":[{"name":"Part II: Encorafenib + Binimetinib + Ribociclib","n":38,"value":10.4,"note":"95% CI 6.0 to 16.7; Figures from the ClinicalTrials.gov results section (first posted 2024-03-05), not from a publication"},{"name":"Part II: Encorafenib + Binimetinib + Infigratinib","n":1,"value":20.8,"note":"95% CI NA to NA"},{"name":"Part II: Encorafenib + Binimetinib + Capmatinib","n":13,"value":5.6,"note":"95% CI 1.7 to NA"},{"name":"Part II: Encorafenib + Binimetinib + Buparlisib","n":6,"value":2.5,"note":"95% CI 0.4 to NA"}],"source":"https://clinicaltrials.gov/study/NCT02159066?tab=results"},{"endpoint":"Progression-Free Survival (PFS): Part I","unit":"months","arms":[{"name":"Part I: Encorafenib + Binimetinib (Naive)","n":75,"value":11.1,"note":"95% CI 8.1 to 15.0; Figures from the ClinicalTrials.gov results section (first posted 2024-03-05), not from a publication"},{"name":"Part I: Encorafenib + Binimetinib (Non-naive)","n":83,"value":3.3,"note":"95% CI 2.1 to 4.7"}],"source":"https://clinicaltrials.gov/study/NCT02159066?tab=results"}]},{"id":"libretto-431","kind":"trial","name":"LIBRETTO-431","aka":[],"tldr":"Proved that a RET pill is better than chemotherapy with or without immunotherapy as first treatment for RET-fusion lung cancer.","summary":"LIBRETTO-431, trial NCT04194944 sponsored by Eli Lilly and reported in 2023, proved that the RET inhibitor selpercatinib is better than platinum-pemetrexed chemotherapy, with or without pembrolizumab, as first treatment for RET-fusion advanced non-small-cell lung cancer. It randomised 261 patients, met its primary progression-free survival endpoint by blinded review with a large effect, and produced more intracranial responses than the chemotherapy-based arm. OnCo links it to RET as a target, to LIBRETTO-531 in thyroid cancer, and to the pairing that places targeted therapy before immunotherapy in driver-positive lung cancer, a rule this trial reinforced; the result is consistent with LIBRETTO-001 and with pralsetinib in ARROW. Whether resistance after selpercatinib can be met by next-generation RET inhibitors is the open question. Selpercatinib has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT04194944","url":"https://clinicaltrials.gov/study/NCT04194944"}],"tags":[],"related":[],"cancers":["nsclc","ret-fusion-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["ret"],"drugs":["selpercatinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-libretto-431-nejm-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04194944","phase":"3","setting":"First-line RET-fusion advanced NSCLC: selpercatinib vs platinum-pemetrexed ± pembrolizumab","sponsor":"Eli Lilly","result":"PFS HR 0.46.","started":"2020-02-17","startedType":"actual","yearReported":2023,"enrolled":261,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR), ITT-pembrolizumab population","primary":true,"unit":"months","arms":[{"name":"Selpercatinib","n":129,"value":24.8},{"name":"Platinum-pemetrexed ± pembrolizumab","n":83,"value":11.2}],"hr":0.46,"ci":[0.31,0.7],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2309457"}],"replication":"Consistent with the single-arm LIBRETTO-001 (ORR 84% treatment-naive); pralsetinib (ARROW) supports the RET class."},{"id":"libretto-531","kind":"trial","name":"LIBRETTO-531","aka":[],"tldr":"Showed that a drug built specifically for the RET mutation beats the older multi-target pills in medullary thyroid cancer, with far fewer side effects.","summary":"LIBRETTO-531, trial NCT04211337 sponsored by Eli Lilly and reported in 2023, showed that a drug built specifically for the RET mutation beats the older multi-target tablets in untreated progressive RET-mutant medullary thyroid cancer, with far fewer side effects. It randomised 291 patients to selpercatinib or cabozantinib or vandetanib, met its primary progression-free survival endpoint with a large effect, improved treatment failure-free survival and roughly halved the rate of severe adverse events, the first randomised proof that RET-selective therapy should be first line. OnCo links it to thyroid cancer and multiple endocrine neoplasia syndromes, kinase inhibitors, RET as a target, selpercatinib, vandetanib, LIBRETTO-431 and Lori J. Wirth. Whether resistance to selective RET inhibition can be met by next-generation drugs is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04211337","url":"https://clinicaltrials.gov/study/NCT04211337"},{"label":"NEJM 2023","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2309719"}],"tags":[],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["ret"],"drugs":["selpercatinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":["libretto-431"],"people":["lori-wirth"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04211337","phase":"3","setting":"Untreated progressive RET-mutant medullary thyroid cancer: selpercatinib vs cabozantinib or vandetanib","sponsor":"Eli Lilly","result":"PFS HR 0.28; 12-month PFS 86.8% vs 65.7%.","started":"2020-02-11","startedType":"actual","yearReported":2023,"enrolled":291,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 12 months","primary":true,"unit":"%","arms":[{"name":"Selpercatinib","value":86.8},{"name":"Cabozantinib or vandetanib","value":65.7}],"hr":0.28,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2309719"}],"replication":"Consistent with single-arm LIBRETTO-001 and with pralsetinib (ARROW) activity in RET-mutant MTC."},{"id":"lidera","kind":"trial","name":"lidERA","aka":[],"tldr":"The first oral SERD to reduce recurrence after surgery, by about 30%, compared with today's hormone pills.","summary":"Presented SABCS December 2025: ~30% reduction in invasive disease-free survival events versus standard endocrine therapy, consistent across menopausal status (ASCO 2026 subgroup: 35% pre-, 26% post-menopausal). Regulatory submission planned. If approved, the first change to adjuvant endocrine backbone since aromatase inhibitors.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04961996","url":"https://clinicaltrials.gov/study/NCT04961996"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":["endocrine-therapy"],"targets":["estrogen-receptor"],"drugs":["giredestrant"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04961996","phase":"3","setting":"Adjuvant ER+/HER2- early breast cancer (medium-high risk): giredestrant vs standard endocrine therapy for 5 years","sponsor":"Roche / Genentech","result":"iDFS ~30% relative reduction (HR ~0.70).","started":"2021-08-27","startedType":"actual","yearReported":2025,"enrolled":4170,"enrolledBasis":"registry","outcomes":[{"endpoint":"Invasive disease-free survival","primary":true,"arms":[{"name":"Giredestrant","note":"30% reduction in iDFS events vs standard ET"},{"name":"Standard endocrine therapy"}],"hr":0.7,"source":"https://www.roche.com/media/releases/med-cor-2026-05-19"}],"replication":"Awaits CAMBRIA-1/-2 (camizestrant) and EMBER-4 (imlunestrant) adjuvant readouts."},{"id":"nct06831955","kind":"trial","name":"LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer","aka":["LESLIE"],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Universitaire Ziekenhuizen KU Leuven, now recruiting.","summary":"LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer is a phase 2, randomised interventional study registered as NCT06831955 by Universitaire Ziekenhuizen KU Leuven, with a registry enrolment figure of 356 participants, started 2026-02-01 and due to reach its primary completion in 2028-09-01. Interventions recorded: Exercise Therapy; Fasting-Mimicking Diet; SOC. Conditions listed: Triple Negative Breast Cancer (TNBC), Early Setting. Triple-negative eligibility wording from the registry: \"* The patient has a biopsy-confirmed diagnosis of stage II-III TNBC\". Sites: Belgium. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06831955","url":"https://clinicaltrials.gov/study/NCT06831955"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06831955","phase":"2","setting":"The LESLIE Trial: LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Systemic Therapy in Patients With Triple Negative Breast Cancer","sponsor":"Universitaire Ziekenhuizen KU Leuven","started":"2026-02-01","startedType":"actual","enrolled":356,"enrolledBasis":"registry","outcomes":[]},{"id":"liger-hn1","kind":"trial","name":"LiGeR-HN1","aka":[],"tldr":"Tests whether a two-armed antibody against EGFR and a stem-cell marker can lift first-line immunotherapy results in head and neck cancer.","summary":"Phase 2 petosemtamab + pembrolizumab reported ORR ~63% in first-line PD-L1-positive HNSCC (ASCO 2025), far above pembrolizumab's historical ~19-23%. LiGeR-HN1 (first line, includes HPV-positive disease) and LiGeR-HN2 (second line, monotherapy vs chemotherapy) are the registrational trials; interim analyses expected 2026-27.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06525220","url":"https://clinicaltrials.gov/study/NCT06525220"}],"tags":[],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["bispecific-antibody"],"targets":["egfr","lgr5"],"drugs":["petosemtamab","pembrolizumab"],"companies":["merus","genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06525220","phase":"3","setting":"Untreated PD-L1-positive recurrent or metastatic HNSCC: petosemtamab + pembrolizumab vs pembrolizumab","sponsor":"Merus (Genmab)","started":"2024-09-25","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"nct06789848","kind":"trial","name":"Ligufalimab and Cadonilimab in Advanced Liver Cancers","aka":[],"tldr":"A phase 2 trial of cadonilimab in gallbladder cancer and other biliary tract cancers, run by University of Texas Southwestern Medical Center, now recruiting.","summary":"Ligufalimab and Cadonilimab in Advanced Liver Cancers is a phase 2 interventional study registered as NCT06789848 by University of Texas Southwestern Medical Center, with a registry enrolment figure of 64 participants, started 2025-02-18 and due to reach its primary completion in 2029-05-31. Interventions recorded: Ligufalimab, Cadonilimab. Conditions listed: Advanced Hepatocellular Carcinoma, Refractory Hepatocellular Carcinoma, Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: \"* Cohort B (BTC, biliary tract cancers): Patients must have histologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancers). Patients w\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06789848","url":"https://clinicaltrials.gov/study/NCT06789848"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["cadonilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06789848","phase":"2","setting":"Phase II Basket Trial of Ligufalimab (AK117) and Cadonilimab (AK104) in Advanced Hepatobiliary Cancers","sponsor":"University of Texas Southwestern Medical Center","started":"2025-02-18","startedType":"actual","enrolled":64,"enrolledBasis":"registry","outcomes":[]},{"id":"linker-mm1","kind":"trial","name":"LINKER-MM1","aka":[],"tldr":"LINKER-MM1 is the pivotal study for linvoseltamab, with 45% complete responses.","summary":"LINKER-MM1, trial NCT03761108 sponsored by Regeneron and reported in 2024, is the pivotal single-arm study for linvoseltamab, a BCMA bispecific, in relapsed or refractory myeloma after at least three prior lines. In 117 patients at the 200 mg dose the response rate was 70 percent with complete response or better in 45 percent and median progression-free survival not reached at fourteen months, the basis for accelerated approval in July 2025. OnCo links it to multiple myeloma, linvoseltamab and the MagnetisMM-3 paper. As a third BCMA bispecific, whether its higher complete response rate holds in a randomised comparison is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03761108","url":"https://clinicaltrials.gov/study/NCT03761108"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["linvoseltamab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03761108","phase":"1/2","setting":"Relapsed/refractory myeloma after ≥3 lines: linvoseltamab 200 mg","sponsor":"Regeneron","result":"ORR 70%, ≥CR 45%.","started":"2019-01-23","startedType":"actual","yearReported":2024,"enrolled":117,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Linvoseltamab 200 mg","n":117,"value":70}],"source":"https://doi.org/10.1200/JCO.24.01008"}]},{"id":"nct07047560","kind":"trial","name":"Liposomal Irinotecan (II) Fractionated Dosing Combined With 5-FU/LV (FOLFIRInali-3) and Bevacizumab in Second-line Treatment of Advanced Colorectal Cancer: A Si","aka":["FOLFIRInali-3"],"tldr":"A phase 2 trial in colorectal cancer, run by Tianjin Medical University Cancer Institute and Hospital, now recruiting.","summary":"Liposomal Irinotecan (II) Fractionated Dosing Combined With 5-FU/LV (FOLFIRInali-3) and Bevacizumab in Second-line Treatment of Advanced Colorectal Cancer: A Single-arm, Phase II Clinical Study is a phase 2, interventional study registered as NCT07047560 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 46 participants, started 2024-09-01 and due to reach its primary completion in 2026-08-01. Interventions recorded: fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev). Conditions listed: Colorectal Cancer (CRC). Primary outcome: Objective Response Rate,ORR. Colorectal eligibility wording from the registry: \"Patients with pathologically confirmed advanced colorectal carcinoma (all other histological types excluded);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07047560","url":"https://clinicaltrials.gov/study/NCT07047560"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07047560","phase":"2","setting":"Liposomal Irinotecan (II) Fractionated Dosing Combined With 5-FU/LV (FOLFIRInali-3) and Bevacizumab in Second-line Treatment of Advanced Colorectal Cancer: A Single-arm, Phase II Clinical Study","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2024-09-01","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06782685","kind":"trial","name":"Liposomal Irinotecan + Oxaliplatin + Bevacizumab Versus Liposomal Irinotecan + 5-FU/LV","aka":[],"tldr":"A phase 1/2 trial of cAPOX (capecitabine, oxaliplatin), bevacizumab, fluorouracil (5-FU) and leucovorin (folinic acid) in pancreatic cancer, run by Dai, Guanghai, now recruiting.","summary":"Liposomal Irinotecan + Oxaliplatin + Bevacizumab Versus Liposomal Irinotecan + 5-FU/LV is a phase 1/2, randomised interventional study registered as NCT06782685 by Dai, Guanghai, with a registry enrolment figure of 138 participants, started 2024-06-23 and due to reach its primary completion in 2026-07. Interventions recorded: Irinotecan liposoma; oxaliplatin; bevacizumab; 5-FU; LV; Irinotecan Liposomal; Irinotecan Liposomal; Oxaliplatin. Conditions listed: Advanced Pancreatic Cancer (Part 1). Primary outcome: To explore the optimal dose combination of irinotecan liposomes plus oxaliplatin in the regimen of irinotecan liposomes plus oxaliplatin in bevacizumab. Pancreatic eligibility wording from the registry: \"Patients with pancreatic cancer diagnosed by histopathology or cytology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06782685","url":"https://clinicaltrials.gov/study/NCT06782685"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capox","bevacizumab","fluorouracil","leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06782685","phase":"1/2","setting":"Liposomal Irinotecan in Combination With Oxaliplatin and Bevacizumab Versus Liposomal Irinotecan in Combination With 5-FU/LV for the Second-line Treatment of Advanced Pancreatic Cancer","sponsor":"Dai, Guanghai","started":"2024-06-23","startedType":"actual","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06192680","kind":"trial","name":"Liposomal Irinotecan and Capecitabine Plus Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of irinotecan (and liposomal irinotecan), capecitabine and bevacizumab (glioblastoma use) in colorectal cancer, run by Harbin Medical University, not yet recruiting.","summary":"Liposomal Irinotecan and Capecitabine Plus Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06192680 by Harbin Medical University, with a registry enrolment figure of 63 participants, started 2024-04-01 and due to reach its primary completion in 2025-11-30. Interventions recorded: Liposomal irinotecan; Capecitabine; Bevacizumab. Conditions listed: Colorectal Cancer. Primary outcome: Progression free Survival. Colorectal eligibility wording from the registry: \"* Histopathologically and/or cytologically confirmed unresectable metastatic colorectal adenocarcinoma, and patients failed or are intolerant to first-line treatment with oxaliplatin ± VEGF/EGFR\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06192680","url":"https://clinicaltrials.gov/study/NCT06192680"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["irinotecan","capecitabine","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06192680","phase":"2","setting":"A Multicenter, Single-arm Study of Liposomal Irinotecan and Capecitabine Plus Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer","sponsor":"Harbin Medical University","started":"2024-04-01","startedType":"estimated","enrolled":63,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06184698","kind":"trial","name":"Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer","aka":["IRIS"],"tldr":"A phase 2 trial of irinotecan (and liposomal irinotecan), fluorouracil (5-FU), leucovorin (folinic acid) and bevacizumab (glioblastoma use) in colorectal cancer, run by Hebei Medical University Fourth Hospital, now recruiting.","summary":"Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06184698 by Hebei Medical University Fourth Hospital, with a registry enrolment figure of 173 participants, started 2024-01-01 and due to reach its primary completion in 2026-02-01. Interventions recorded: liposomal irinotecan; 5-FU; LV; Bevacizumab. Conditions listed: Colorectal Cancer. Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"* Histologically or cytologically proven colon or rectum adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06184698","url":"https://clinicaltrials.gov/study/NCT06184698"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["irinotecan","fluorouracil","leucovorin","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06184698","phase":"2","setting":"Liposomal Irinotecan + Leucovorin + 5-fluorouracil + Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer (IRIS)：a Multicenter, Single-arm, Prospective, Phase II Study","sponsor":"Hebei Medical University Fourth Hospital","started":"2024-01-01","startedType":"actual","enrolled":173,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06571461","kind":"trial","name":"Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Canc","aka":[],"tldr":"A phase 3 trial of liposomal irinotecan, cAPOX (capecitabine, oxaliplatin), tegafur, gimeracil and oteracil (S-1), gemcitabine and other drugs in pancreatic cancer, run by CSPC Ouyi Pharmaceutical Co., Ltd., not yet recruiting.","summary":"Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer is a phase 3, randomised interventional study registered as NCT06571461 by CSPC Ouyi Pharmaceutical Co., Ltd., with a registry enrolment figure of 408 participants, started 2024-09 and due to reach its primary completion in 2028-01. Interventions recorded: Liposomal Irinotecan; Oxaliplatin; S-1; Gemcitabine; Capecitabine. Conditions listed: Pancreatic Cancer. Primary outcome: Disease-free survival (DFS). Pancreatic eligibility wording from the registry: \"Histologically confirmed resected ductal pancreatic adenocarcinoma (including adenosquamous carcinoma)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06571461","url":"https://clinicaltrials.gov/study/NCT06571461"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["liposomal-irinotecan","capox","tegafur-gimeracil-oteracil","gemcitabine","capecitabine"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06571461","phase":"3","setting":"A Randomized, Open-label, Multi-center Phase III Clinical Study of Liposomal Irinotecan Combined With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine for Postoperative Adjuvant Treatment of Pancreatic Cancer","sponsor":"CSPC Ouyi Pharmaceutical Co., Ltd.","started":"2024-09","startedType":"estimated","enrolled":408,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07797816","kind":"trial","name":"Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT for Locally Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of sintilimab, fluorouracil, leucovorin and liposomal irinotecan with radiotherapy in gallbladder cancer and other biliary tract cancers, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, now recruiting.","summary":"Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT for Locally Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT07797816 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, with a registry enrolment figure of 31 participants, started 2026-01-08 and due to reach its primary completion in 2028-12-31. Interventions recorded: Irinotecan Hydrochloride Liposome Injection (II), Fluorouracil, Leucovorin, Sintilimab, Stereotactic Body Radiation Therapy, Radical Surgical Resection. Conditions listed: Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: \"2. Histologically and/or cytologically confirmed biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07797816","url":"https://clinicaltrials.gov/study/NCT07797816"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","sbrt"],"targets":[],"drugs":["sintilimab","fluorouracil","leucovorin","liposomal-irinotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07797816","phase":"2","setting":"A Prospective, Single-Arm, Exploratory Clinical Study of Liposomal Irinotecan (II) Plus 5-Fluorouracil/Leucovorin and Sintilimab With Sequential Stereotactic Body Radiation Therapy as First-Line Treatment for Locally Advanced Biliary Tract Cancer","sponsor":"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","started":"2026-01-08","startedType":"actual","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05854498","kind":"trial","name":"Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of irinotecan (and liposomal irinotecan) and bevacizumab (glioblastoma use) in colorectal cancer, run by University of Wisconsin, Madison, now recruiting.","summary":"Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT05854498 by University of Wisconsin, Madison, with a registry enrolment figure of 50 participants, started 2023-10-13 and due to reach its primary completion in 2028-09. Interventions recorded: Liposomal irinotecan; TAS102; Bevacizumab. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Progression Free Survival (PFS). Colorectal eligibility wording from the registry: \"* Patients must have a histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and be metastatic or unresectable\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05854498","url":"https://clinicaltrials.gov/study/NCT05854498"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["irinotecan","bevacizumab-glioma"],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05854498","phase":"2","setting":"Phase II Study of Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer","sponsor":"University of Wisconsin, Madison","started":"2023-10-13","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07542002","kind":"trial","name":"Liposomal Irinotecan, 5-fluorouracil/Calcium Folinate, Oxaliplatin, and Adebrelimab in Combination With Radiotherapy for Resectable or Borderline Resectable Pan","aka":[],"tldr":"A phase 2 trial of fLOT (5-FU, leucovorin, oxaliplatin, docetaxel) and cAPOX (capecitabine, oxaliplatin) in pancreatic cancer, run by Ningbo Medical Center Lihuili Hospital, now recruiting.","summary":"Liposomal Irinotecan, 5-fluorouracil/Calcium Folinate, Oxaliplatin, and Adebrelimab in Combination With Radiotherapy for Resectable or Borderline Resectable Pancreatic Cancer With Risk Factors：A Prospective Exploratory Study is a phase 2, interventional study registered as NCT07542002 by Ningbo Medical Center Lihuili Hospital, with a registry enrolment figure of 37 participants, started 2025-03-25 and due to reach its primary completion in 2026-05-31. Interventions recorded: Irinotecan liposome, 5-fluorouracil/leucovorin, and oxaliplatin, with or without adadelimab.. Conditions listed: Pancreatic Cancer. Primary outcome: The R0 resection rate. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed pancreatic cancer (arising from the pancreatic ductal epithelium), as assessed by a multidisciplinary team (MDT), with clinical records indicating resectable or borderline resectable pancreatic cancer with high-risk factors\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07542002","url":"https://clinicaltrials.gov/study/NCT07542002"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["flot","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07542002","phase":"2","setting":"Liposomal Irinotecan, 5-fluorouracil/Calcium Folinate, Oxaliplatin, and Adebrelimab in Combination With Radiotherapy for Resectable or Borderline Resectable Pancreatic Cancer With Risk Factors：A Prospective Exploratory Study","sponsor":"Ningbo Medical Center Lihuili Hospital","started":"2025-03-25","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07281157","kind":"trial","name":"Liposomal Irinotecan, Capecitabine and Enlonstobart With Short-Course Radiotherapy for Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Tianjin Medical University Cancer Institute and Hospital, now recruiting.","summary":"Liposomal Irinotecan, Capecitabine and Enlonstobart With Short-Course Radiotherapy for Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT07281157 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 30 participants, started 2025-11-01 and due to reach its primary completion in 2027-04-30. Interventions recorded: Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy. Conditions listed: Advanced Rectal Cancer. Primary outcome: Complete response plus pathological complete response. Colorectal eligibility wording from the registry: \"rectal adenocarcinoma confirmed by histology and/or cytology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07281157","url":"https://clinicaltrials.gov/study/NCT07281157"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07281157","phase":"2","setting":"Liposomal Irinotecan, Capecitabine, and Enlonstobart Combined With Short-Course Radiotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Prospective, Single-Center, Single-Arm Study","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2025-11-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06391892","kind":"trial","name":"Liquid Biopsy (ctDNA) Guided Treatment in Localized Pancreatic Cancer: Neoadjuvant CTX vs. Upfront Surgery","aka":["LIQUIPANC"],"tldr":"A phase 3 trial in pancreatic cancer, run by Elisabethinen Hospital, now recruiting.","summary":"Liquid Biopsy (ctDNA) Guided Treatment in Localized Pancreatic Cancer: Neoadjuvant CTX vs. Upfront Surgery is a phase 3, interventional study registered as NCT06391892 by Elisabethinen Hospital, with a registry enrolment figure of 100 participants, started 2024-01-11 and due to reach its primary completion in 2025-12-31. Interventions recorded: Neoadjuvant chemotherapy instead of upfront surgery; Upfront surgery. Conditions listed: Pancreatic Cancer; Circulating Tumor Cell; Predictive Cancer Model. Primary outcome: DFS. Pancreatic eligibility wording from the registry: \"* localized pancreatic cancer to go for upfront surgery\". Sites: Austria. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06391892","url":"https://clinicaltrials.gov/study/NCT06391892"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06391892","phase":"3","setting":"Liquid Biopsy Guided Treatment in Localized Pancreatic Cancer (LIQUIPANC): Circulating Tumor DNA (ctDNA) as Precision Medicine Tool for Stratification of Neoadjuvant Chemotherapy vs. Upfront Surgery","sponsor":"Elisabethinen Hospital","started":"2024-01-11","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"litespark-005","kind":"trial","name":"LITESPARK-005","aka":[],"tldr":"The HIF-2α inhibitor beat the old standard everolimus after immunotherapy and targeted therapy had failed, with durable responses in a subset.","summary":"LITESPARK-005, trial NCT04195750 sponsored by Merck and reported in 2023, showed that the HIF-2-alpha inhibitor belzutifan beats the old standard everolimus in advanced clear-cell renal cell carcinoma after immunotherapy and a VEGF kinase inhibitor have failed, with durable responses in a subset. It randomised 746 patients, met its primary progression-free survival endpoint with a much higher response rate, did not significantly improve overall survival, and led to FDA approval in December 2023, with anaemia and low oxygen as on-mechanism toxicities. OnCo links it to renal cell carcinoma, HIF-2-alpha as a target, belzutifan, everolimus, Laurence Albiges and Toni K. Choueiri, and belzutifan's activity was also shown in VHL disease in LITESPARK-004 while the first-line combination LITESPARK-012 failed in 2026. Whether the responders can be identified in advance is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04195750","url":"https://clinicaltrials.gov/study/NCT04195750"}],"tags":[],"related":[],"cancers":["rcc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["hif2a"],"drugs":["belzutifan","everolimus"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["laurence-albiges","toni-choueiri"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04195750","phase":"3","setting":"Advanced clear-cell RCC after PD-1/PD-L1 and VEGF-TKI: belzutifan vs everolimus","sponsor":"Merck","result":"PFS HR 0.75; ORR 22.7% vs 3.5%; OS not significant.","started":"2020-02-27","startedType":"actual","yearReported":2023,"enrolled":755,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"arms":[{"name":"Belzutifan","n":374},{"name":"Everolimus","n":372}],"hr":0.75,"ci":[0.63,0.9],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2313906"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Belzutifan","value":22.7},{"name":"Everolimus","value":3.5}],"source":"https://doi.org/10.1056/NEJMoa2313906"}],"replication":"Belzutifan activity replicated in VHL disease (LITESPARK-004); first-line combination (LITESPARK-012) did not meet its goal in 2026."},{"id":"nct04586231","kind":"trial","name":"LITESPARK-011","aka":["LITESPARK 011","MK-6482-011","A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)"],"tldr":"In LITESPARK-011, belzutifan plus lenvatinib held advanced clear-cell kidney cancer in check for about four months longer than cabozantinib in people whose cancer had grown after immunotherapy, but at the interim look it had not been shown to help them live longer; a final survival analysis is still to come.","summary":"LITESPARK-011 (NCT04586231; MK-6482-011) is an open-label, randomised, active-controlled phase 3 trial at 184 centres in 25 countries, sponsored by Merck Sharp & Dohme with Eisai. Adults with advanced unresectable, locally advanced or metastatic clear-cell renal cell carcinoma whose disease had progressed after anti-PD-1 or anti-PD-L1 therapy, with or without a prior VEGFR tyrosine kinase inhibitor, were randomly assigned 1:1 to belzutifan 120 mg plus lenvatinib 20 mg or to cabozantinib 60 mg, all taken by mouth once daily until progression or unacceptable toxicity. Randomisation was stratified by IMDC prognostic score, line of previous immunotherapy and region. The dual primary endpoints were progression-free survival by masked independent central review and overall survival in all randomised participants; the study counted as positive if either was met.\n\nBetween March 2021 and September 2023, 955 people were screened and 747 randomised (371 to belzutifan plus lenvatinib, 376 to cabozantinib). At the second interim analysis (data cutoff 9 April 2025; median follow-up 29.0 months), which was the final analysis for progression-free survival, median progression-free survival was 14.8 months (95 percent CI 11.2 to 16.6) with belzutifan plus lenvatinib against 10.7 months (9.2 to 11.1) with cabozantinib (hazard ratio 0.70, 0.59 to 0.84; one-sided p less than 0.0001). Overall survival, an interim result, was not significantly different: median 34.9 months (27.5 to not reached) against 27.6 months (24.0 to 31.4), hazard ratio 0.85 (0.68 to 1.05), one-sided p 0.061. Grade 3 or worse treatment-emergent adverse events occurred in 311 of 370 (84 percent) and 307 of 371 (83 percent) treated participants, most often hypertension (31 and 29 percent); treatment-related adverse events led to two deaths on belzutifan plus lenvatinib and one on cabozantinib (Lancet, 12 August 2026).\n\nThe investigator presentation at ASCO GU 2026 (same cutoff) reported descriptive figures that the abstract does not: confirmed objective response by central review 52.6 percent against 40.2 percent (a key secondary endpoint that was statistically significant at the first interim analysis, 52.6 against 39.6 percent, one-sided p 0.0002, and not retested), median duration of response 23.0 against 12.3 months among 195 and 151 responders, grade 3 or worse treatment-related adverse events 71.6 against 65.8 percent, and discontinuation of all study drugs for adverse events 11.1 against 11.3 percent. The authors conclude that belzutifan plus lenvatinib is an efficacious option and may become a new standard after immunotherapy, while noting that overall survival was not significantly different. The registry lists the trial as active, not recruiting, with primary completion recorded on 2 February 2026 and study completion expected in February 2027; no regulatory decision on the combination had been announced when this record was written.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04586231","url":"https://clinicaltrials.gov/study/NCT04586231"},{"label":"Lancet 2026","url":"https://doi.org/10.1016/S0140-6736(26)01089-5"},{"label":"ASCO GU 2026 investigator presentation (Eisai medical information)","url":"https://www.eisaimedicalinformation.com/-/media/Files/EisaiMedicalInformation/Oncology/Congress-Materials/ASCO-GU-2026/Motzer_LS011_ASCO-GU-2026_Presented.pdf"}],"tags":["pipeline","issue-98"],"related":[],"cancers":["rcc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["belzutifan","lenvatinib","cabozantinib"],"companies":["merck","eisai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["robert-motzer"],"bottlenecks":[],"keyPapers":["paper-litespark-011-motzer-lancet-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04586231","phase":"3","setting":"Advanced clear-cell renal cell carcinoma that has progressed after anti-PD-1 or anti-PD-L1 therapy: belzutifan 120 mg plus lenvatinib 20 mg versus cabozantinib 60 mg, all oral once daily, open label, randomised 1:1","sponsor":"Merck Sharp & Dohme LLC","result":"Final progression-free survival 14.8 vs 10.7 months (hazard ratio 0.70, 95% CI 0.59 to 0.84; one-sided p<0.0001). Interim overall survival 34.9 vs 27.6 months (hazard ratio 0.85, 0.68 to 1.05; one-sided p 0.061), not statistically significant. Data cutoff 9 April 2025.","started":"2021-02-25","startedType":"actual","yearReported":2026,"enrolled":747,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival by masked independent central review (final analysis at the second interim analysis, data cutoff 9 April 2025)","primary":true,"unit":"months","arms":[{"name":"Belzutifan + lenvatinib","n":371,"value":14.8,"note":"Median; 95% CI 11.2 to 16.6; median follow-up 29.0 months (IQR 23.7 to 34.9)"},{"name":"Cabozantinib","n":376,"value":10.7,"note":"Median; 95% CI 9.2 to 11.1"}],"hr":0.7,"ci":[0.59,0.84],"p":"<0.0001 (one-sided)","source":"https://doi.org/10.1016/S0140-6736(26)01089-5"},{"endpoint":"Overall survival (interim analysis at the second interim analysis, data cutoff 9 April 2025)","primary":true,"unit":"months","arms":[{"name":"Belzutifan + lenvatinib","n":371,"value":34.9,"note":"Median; 95% CI 27.5 to not reached; the difference was not statistically significant, so a survival benefit is not established"},{"name":"Cabozantinib","n":376,"value":27.6,"note":"Median; 95% CI 24.0 to 31.4"}],"hr":0.85,"ci":[0.68,1.05],"p":"0.061 (one-sided)","source":"https://doi.org/10.1016/S0140-6736(26)01089-5"},{"endpoint":"Grade 3 or worse treatment-emergent adverse events (treated participants)","unit":"%","arms":[{"name":"Belzutifan + lenvatinib","n":370,"value":84,"note":"311 of 370; hypertension the commonest at 31%; two treatment-related deaths"},{"name":"Cabozantinib","n":371,"value":83,"note":"307 of 371; hypertension 29%; one treatment-related death"}],"source":"https://doi.org/10.1016/S0140-6736(26)01089-5"},{"endpoint":"Confirmed objective response rate by masked independent central review (key secondary; second interim analysis, descriptive)","unit":"%","arms":[{"name":"Belzutifan + lenvatinib","n":371,"value":52.6,"note":"Conference data (ASCO GU 2026 investigator presentation, Motzer): 95% CI 47.3 to 57.7; complete response 5.4%; the endpoint was statistically significant at the first interim analysis (52.6% vs 39.6%, one-sided p 0.0002) and not retested"},{"name":"Cabozantinib","n":376,"value":40.2,"note":"Conference data: 95% CI 35.2 to 45.3; complete response 1.1%"}],"source":"https://www.eisaimedicalinformation.com/-/media/Files/EisaiMedicalInformation/Oncology/Congress-Materials/ASCO-GU-2026/Motzer_LS011_ASCO-GU-2026_Presented.pdf"},{"endpoint":"Median duration of response by masked independent central review (second interim analysis, descriptive)","unit":"months","arms":[{"name":"Belzutifan + lenvatinib","n":195,"value":23,"note":"Conference data (ASCO GU 2026): among 195 responders; range 2.0 to 44.3 or more"},{"name":"Cabozantinib","n":151,"value":12.3,"note":"Conference data: among 151 responders; range 1.8 or more to 35.9 or more"}],"source":"https://www.eisaimedicalinformation.com/-/media/Files/EisaiMedicalInformation/Oncology/Congress-Materials/ASCO-GU-2026/Motzer_LS011_ASCO-GU-2026_Presented.pdf"},{"endpoint":"Grade 3 or worse treatment-related adverse events (as-treated population, descriptive)","unit":"%","arms":[{"name":"Belzutifan + lenvatinib","n":370,"value":71.6,"note":"Conference data (ASCO GU 2026): 265 of 370; serious treatment-emergent adverse events 51.6%; discontinuation of all study drugs for adverse events 11.1%; treatment-related deaths 0.5%"},{"name":"Cabozantinib","n":371,"value":65.8,"note":"Conference data: 244 of 371; serious treatment-emergent adverse events 43.9%; discontinuation of all study drugs 11.3%; treatment-related deaths 0.3%"}],"source":"https://www.eisaimedicalinformation.com/-/media/Files/EisaiMedicalInformation/Oncology/Congress-Materials/ASCO-GU-2026/Motzer_LS011_ASCO-GU-2026_Presented.pdf"}],"replication":"First phase 3 of a HIF-2 alpha inhibitor combination after immunotherapy in kidney cancer; no independent trial has tested the pair. LITESPARK-012 (first-line triplet) fell short and LITESPARK-022 (adjuvant belzutifan plus pembrolizumab) was positive, so the drug's benefit depends on setting and partner. The final overall survival analysis is awaited."},{"id":"litespark-012","kind":"trial","name":"LITESPARK-012","aka":[],"tldr":"Adding belzutifan to first-line lenvatinib-pembrolizumab did not deliver, a reminder that later-line success does not guarantee first-line benefit.","summary":"LITESPARK-012, trial NCT04736706 sponsored by Merck and reported at ASCO GU 2026, found that adding belzutifan, or the CTLA-4 antibody quavonlimab, to first-line lenvatinib plus pembrolizumab in untreated advanced clear-cell renal cell carcinoma did not deliver, a reminder that later-line success does not guarantee first-line benefit. It randomised 1,688 patients across three arms, and neither investigational triplet met the dual primary endpoints of progression-free and overall survival at the pre-specified interim analysis announced on 21 April 2026, with hazard ratios not disclosed. OnCo links it to renal cell carcinoma, belzutifan, lenvatinib and pembrolizumab. Belzutifan's role is therefore later line and adjuvant, and why the phase 1b/2 KEYMAKER-U03 signal did not carry into phase 3 is the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04736706","url":"https://clinicaltrials.gov/study/NCT04736706"},{"label":"CURE report","url":"https://www.curetoday.com/view/litespark-012-trial-falls-short-in-advanced-kidney-cancer"}],"tags":["lesson:first-line-intensification"],"related":[],"cancers":["rcc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["belzutifan","lenvatinib","pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04736706","phase":"3","setting":"Untreated advanced clear-cell RCC: pembrolizumab + lenvatinib ± belzutifan (or ± quavonlimab)","sponsor":"Merck","result":"Primary endpoint not met (ASCO GU 2026).","started":"2021-04-14","startedType":"actual","yearReported":2026,"enrolled":1854,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR) and overall survival (dual primary)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + lenvatinib + belzutifan","note":"Neither investigational regimen met the dual primary PFS and OS endpoints at the pre-specified interim analysis (sponsor release, 21 April 2026); hazard ratios not disclosed"},{"name":"Pembrolizumab/quavonlimab + lenvatinib"},{"name":"Pembrolizumab + lenvatinib"}],"source":"https://www.merck.com/news/merck-and-eisai-provide-update-on-phase-3-litespark-012-trial-evaluating-first-line-combination-treatments-for-certain-patients-with-advanced-renal-cell-carcinoma-rcc/"}],"replication":"Consistent with COSMIC-313: adding a third agent to a first-line IO doublet has not improved outcomes in clear-cell RCC. The phase Ib/II KEYMAKER-U03 signal for the belzutifan triplet did not carry into phase 3."},{"id":"litespark-022","kind":"trial","name":"LITESPARK-022","aka":[],"tldr":"Adding the HIF-2α pill to a year of adjuvant pembrolizumab further reduced recurrence, and became the first adjuvant combination approved in kidney cancer.","summary":"LITESPARK-022, trial NCT05239728 sponsored by Merck and reported at ASCO GU 2026, showed that adding the HIF-2-alpha inhibitor belzutifan to a year of adjuvant pembrolizumab after nephrectomy for high-risk clear-cell renal cell carcinoma further reduced recurrence, and it became the first adjuvant combination approved in kidney cancer. It randomised 1,841 patients, met its primary disease-free survival endpoint at the first interim analysis with overall survival immature, and led to FDA approval in the second quarter of 2026, with severe adverse events rising from about thirty to about fifty percent. OnCo links it to renal cell carcinoma, HIF-2-alpha as a target, belzutifan, pembrolizumab and the idea of biomarker-selected adjuvant therapy. Whether the added toxicity is justified in patients who would never have relapsed is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05239728","url":"https://clinicaltrials.gov/study/NCT05239728"},{"label":"Merck ASCO GU 2026","url":"https://www.merck.com/news/merck-advances-treatment-of-bladder-and-kidney-cancers-with-new-data-at-2026-asco-gu-cancers-symposium/"}],"tags":[],"related":[],"cancers":["rcc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["hif2a"],"drugs":["belzutifan","pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05239728","phase":"3","setting":"Clear-cell RCC at high risk after nephrectomy: adjuvant pembrolizumab + belzutifan vs pembrolizumab + placebo","sponsor":"Merck","result":"DFS significantly improved vs pembrolizumab (interim; HR presented ASCO GU 2026).","started":"2022-03-15","startedType":"actual","yearReported":2026,"enrolled":1841,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 24 months (investigator-assessed)","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab + belzutifan","n":921,"value":80.7},{"name":"Pembrolizumab + placebo","n":920,"value":73.7}],"hr":0.72,"ci":[0.59,0.87],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2518245"},{"endpoint":"Overall survival at 24 months (interim, 29% of final events)","unit":"%","arms":[{"name":"Pembrolizumab + belzutifan","value":96.2,"note":"Not significant; immature"},{"name":"Pembrolizumab + placebo","value":95.7}],"hr":0.78,"ci":[0.51,1.19],"p":"0.24","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2518245"}],"replication":"First adjuvant RCC trial to beat pembrolizumab (KEYNOTE-564) rather than placebo; single trial, OS immature, and grade >=3 adverse events rose from 30% to 52%."},{"id":"nct02755311","kind":"trial","name":"Liver Resection Versus Transarterial Chemoembolization for the Treatment of Intermediate-stage Hepatocellular Carcinoma","aka":[],"tldr":"A phase 3 trial of Carboplatin and Ethiodized oil in Hepatocellular carcinoma, run by Sun Yat-sen University, with a status the registry has not verified recently.","summary":"Liver Resection Versus Transarterial Chemoembolization for the Treatment of Intermediate-stage Hepatocellular Carcinoma is a phase 3 interventional study registered as NCT02755311 by Sun Yat-sen University, with 198 participants planned, started 2014-03 and due to reach its primary completion in 2016-06. Interventions recorded: liver resection, transarterial chemoembolization, carboplatin, lipiodol, epirubicin, pirarubicin, hydroxycamptothecin and fluorouracil, absorbable gelatin sponge particles. Conditions recorded: Hepatocellular Carcinoma.\n\nLinked to the drug Ethiodized oil because the registry names it among its interventions and Hepatocellular carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02755311","url":"https://clinicaltrials.gov/study/NCT02755311"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-intermediate"],"sections":[],"technologies":[],"targets":[],"drugs":["carboplatin","ethiodized-oil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02755311","phase":"3","setting":"Liver Resection Versus Transarterial Chemoembolization for the Treatment of Intermediate-stage Hepatocellular Carcinoma: a Prospective Non-randomized Trial","sponsor":"Sun Yat-sen University","started":"2014-03","enrolled":198,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07284394","kind":"trial","name":"Liver-directed Chemotherapy After Surgery of Liver Metastases of Colorectal Cancer in Patients With High Risk of Recurrence of Their Disease","aka":["PACHA-02"],"tldr":"A phase 3 trial in colorectal cancer, run by UNICANCER, not yet recruiting.","summary":"Liver-directed Chemotherapy After Surgery of Liver Metastases of Colorectal Cancer in Patients With High Risk of Recurrence of Their Disease is a phase 3, randomised interventional study registered as NCT07284394 by UNICANCER, with a registry enrolment figure of 272 participants, started 2026-07 and due to reach its primary completion in 2031-01. Interventions recorded: Arterial catheter infusion chemotherapy; IV Chemotherapy (Regimen 1). Conditions listed: Colorectal Adenocarcinoma Metastatic in the Liver; Colorectal Cancer. Primary outcome: Recurrence-free survival (RFS). No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07284394","url":"https://clinicaltrials.gov/study/NCT07284394"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07284394","phase":"3","setting":"Postoperative Hepatic Arterial Chemotherapy After Resection of Colorectal Liver Metastases in Patients at High Risk of Recurrence","sponsor":"UNICANCER","started":"2026-07","startedType":"estimated","enrolled":272,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06387628","kind":"trial","name":"LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of LM-108, toripalimab, eribulin and nab-paclitaxel in triple-negative breast cancer, run by Fudan University, now recruiting.","summary":"LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer is a phase 2, interventional study registered as NCT06387628 by Fudan University, with a registry enrolment figure of 74 participants, started 2024-07-10 and due to reach its primary completion in 2026-04-01. Interventions recorded: LM-108; Toripalimab; Eribulin; Nab paclitaxel. Conditions listed: TNBC - Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Unresectable or metastatic or postoperative recurrent, histologically confirmed advanced triple-negative breast cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06387628","url":"https://clinicaltrials.gov/study/NCT06387628"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["lm-108","toripalimab","eribulin","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06387628","phase":"2","setting":"A Phase II Single Center Two Cohorts Trial of LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer","sponsor":"Fudan University","started":"2024-07-10","startedType":"actual","enrolled":74,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07362186","kind":"trial","name":"LM-108 in Combination With Toripalimab Versus Paclitaxel Injection for the Treatment of Subjects With CCR8-Positive Gastric and Gastroesophageal Junction Adenocarcinoma","aka":[],"tldr":"A phase 3 trial testing LM-108 in gastric & gastro-oesophageal junction cancer, now recruiting.","summary":"LM-108 in Combination With Toripalimab Versus Paclitaxel Injection for the Treatment of Subjects With CCR8-Positive Gastric and Gastroesophageal Junction Adenocarcinoma is a phase 3 interventional study registered as NCT07362186, led by LaNova Medicines, and recruiting on the registry. Official title: A Phase III, Open-Label, Multicenter, Randomised, Parallel-Group Study to Evaluate the Efficacy and Safety of LM-108 in Combination With Toripalimab Versus Paclitaxel Injection as Second-Line Therapy for CCR8-Positive Locally Advanced or Metastatic Gastric Cancer/Gastroesophageal Junction Adenocarcinoma. Planned enrolment is 400 participants (estimated). The study started in 2026-04-30 and primary completion is expected in 2028-08-17. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07362186","url":"https://clinicaltrials.gov/study/NCT07362186"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":[],"targets":[],"drugs":["lm-108"],"companies":["lanova-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07362186","phase":"3","setting":"A Phase III, Open-Label, Multicenter, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of LM-108 in Combination With Toripalimab Versus Paclitaxel Injection as Second-Line Therapy for CCR8-Positive Locally Advanced or Metastatic Gastric Cancer/Gastroesophageal Junction Adenocarcinoma","sponsor":"LaNova Medicines","started":"2026-04-30","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"lms-04","kind":"trial","name":"LMS-04","aka":[],"tldr":"In leiomyosarcoma, adding trabectedin to doxorubicin roughly doubled the time the disease stayed controlled, the first randomised first-line gain in this sarcoma in decades.","summary":"LMS-04 randomised 150 patients with metastatic or unresectable uterine or soft tissue leiomyosarcoma to six cycles of doxorubicin plus trabectedin followed by trabectedin maintenance, or doxorubicin alone. Median progression-free survival was 12.2 months with the combination versus 6.2 months with doxorubicin (hazard ratio 0.41), with more haematological toxicity, and later follow-up also reported improved overall survival. Published in Lancet Oncology in 2022, it established doxorubicin plus trabectedin as a first-line standard for fit patients with leiomyosarcoma and as the model for histology-specific sarcoma trials.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02997358","url":"https://clinicaltrials.gov/study/NCT02997358"},{"label":"Lancet Oncology 2022","url":"https://doi.org/10.1016/S1470-2045(22)00380-1"}],"tags":["subtype-page"],"related":[],"cancers":["leiomyosarcoma","uterine-sarcoma","extremity-soft-tissue-sarcoma","retroperitoneal-sarcoma","sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["doxorubicin","trabectedin"],"companies":["french-sarcoma-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02997358","phase":"3","setting":"Metastatic or unresectable leiomyosarcoma, first line: doxorubicin plus trabectedin (then trabectedin maintenance) versus doxorubicin","sponsor":"French Sarcoma Group / Centre Leon Berard","result":"Median PFS 12.2 vs 6.2 months (HR 0.41); overall survival also favoured the combination at later follow-up.","started":"2017-01-18","startedType":"actual","yearReported":2022,"enrolled":150,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Doxorubicin + trabectedin","value":12.2},{"name":"Doxorubicin","value":6.2}],"hr":0.41,"ci":[0.29,0.58],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(22)00380-1"}]},{"id":"nct07833319","kind":"trial","name":"Local Methylene Blue Injection for Prevention of Anastomotic Leakage and Permanent Stoma After Low Anterior Resection for Rectal Cancer","aka":["PKUCH-R10"],"tldr":"A phase 2 trial in colorectal cancer, run by Peking University Cancer Hospital & Institute, now recruiting.","summary":"Local Methylene Blue Injection for Prevention of Anastomotic Leakage and Permanent Stoma After Low Anterior Resection for Rectal Cancer is a phase 2, interventional study registered as NCT07833319 by Peking University Cancer Hospital & Institute, with a registry enrolment figure of 26 participants, started 2025-11-25 and due to reach its primary completion in 2027-07-01. Interventions recorded: methylene blue injection. Conditions listed: Rectal Cancers. Primary outcome: Proportion of participants with successful stoma closure within 12 months after surgery. Colorectal eligibility wording from the registry: \"Adults aged 18 years or older with histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07833319","url":"https://clinicaltrials.gov/study/NCT07833319"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07833319","phase":"2","setting":"A Prospective Single-arm Phase II Clinical Study Evaluating Local Methylene Blue Injection for Prevention of Anastomotic Leakage and Permanent Stoma in High-risk Patients With Rectal Cancer Undergoing Low Anterior Resection","sponsor":"Peking University Cancer Hospital & Institute","started":"2025-11-25","startedType":"actual","enrolled":26,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06208371","kind":"trial","name":"Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM is a phase 3, randomised interventional study registered as NCT06208371 by Sun Yat-sen University, with a registry enrolment figure of 117 participants, started 2024-01-15 and due to reach its primary completion in 2029-06-30. Interventions recorded: Surgical resection and/or ablation therapy and/or SBRT; Palliative Chemotherapy. Conditions listed: Colorectal Neoplasms Malignant. Primary outcome: Five-year survival rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06208371","url":"https://clinicaltrials.gov/study/NCT06208371"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["sbrt","thermal-ablation"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06208371","phase":"3","setting":"The DECIDE-CRLM-10 Randomized Controlled Study: Comparison of Chemotherapy Combined With Localized Treatment for Liver Metastases Versus Palliative Chemotherapy Alone in Colorectal Patients With 10 or More Liver Metastases","sponsor":"Sun Yat-sen University","started":"2024-01-15","startedType":"actual","enrolled":117,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00143416","kind":"trial","name":"Long Term Study With B2036-PEG","aka":[],"tldr":"A phase 3 trial of Pegvisomant in Pituitary tumours, run by Pfizer, completed.","summary":"Long Term Study With B2036-PEG is a phase 3 interventional study registered as NCT00143416 by Pfizer, with 16 participants recorded, started 2004-04. Interventions recorded: Pegvisomant. Conditions recorded: Acromegaly.\n\nLinked to the drug Pegvisomant because the registry names it among its interventions and Pituitary tumours among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00143416","url":"https://clinicaltrials.gov/study/NCT00143416"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pituitary-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["pegvisomant"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00143416","phase":"3","setting":"Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG -","sponsor":"Pfizer","started":"2004-04","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07150949","kind":"trial","name":"Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC","aka":["SERRAC"],"tldr":"A phase 2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin), capecitabine, celecoxib and serplulimab in colorectal cancer, run by Fudan University, now recruiting.","summary":"Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC) is a phase 2, randomised interventional study registered as NCT07150949 by Fudan University, with a registry enrolment figure of 138 participants, started 2025-08-28 and due to reach its primary completion in 2027-08-31. Interventions recorded: Long-course radiotherapy; Oxaliplatin; Capecitabine; Celecoxib; Short-course radiotherapy; Serplulimab. Conditions listed: Locally Advanced Rectal Cancer; Neoadjuvant Therapy. Primary outcome: Complete response (CR) rate. Colorectal eligibility wording from the registry: \"Pathologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07150949","url":"https://clinicaltrials.gov/study/NCT07150949"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["folfox","capecitabine","celecoxib","serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07150949","phase":"2","setting":"A Prospective Randomized Phase II Trial of Long-Course Chemoradiotherapy or Short-Course Radiotherapy Combined With CAPOX, PD-1 Antibody, and a COX-2 Inhibitor for Microsatellite Stable Locally Advanced Rectal Cancer (SERRAC)","sponsor":"Fudan University","started":"2025-08-28","startedType":"estimated","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07620574","kind":"trial","name":"Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study","aka":[],"tldr":"A phase 3 trial of cabozantinib, zanzalintinib, atezolizumab, nivolumab and other drugs in colorectal cancer, run by Exelixis, now recruiting.","summary":"Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study is a phase 3, interventional study registered as NCT07620574 by Exelixis, with a registry enrolment figure of 5000 participants, started 2026-07-30 and due to reach its primary completion in 2030-05-31. Interventions recorded: Cabozantinib; Zanzalintinib; Atezolizumab; Nivolumab; Abiraterone; Prednisone; Enzalutamide. Conditions listed: Cancer; Renal Cell Carcinoma (RCC); Pancreatic Neuroendocrine Tumors (pNET); Extra-Pancreatic NET (epNET); Hepatocellular Carcinoma (HCC); Differentiated Thyroid Cancer (DTC); Non-Clear Cell Renal Cell Carcinoma (nccRCC); Colorectal Cancer; Prostate Cancer. Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs). Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07620574","url":"https://clinicaltrials.gov/study/NCT07620574"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cabozantinib","zanzalintinib","atezolizumab","nivolumab","abiraterone","prednisone","enzalutamide"],"companies":["exelixis","bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07620574","phase":"3","setting":"Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study","sponsor":"Exelixis","started":"2026-07-30","startedType":"actual","enrolled":5000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06652633","kind":"trial","name":"Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies","aka":["Hesperia"],"tldr":"A phase 3 trial of GLPG CAR T-cell therapy in advanced solid tumours, run by Lakefront Biotherapeutics NV, now recruiting.","summary":"Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies is a phase 3 interventional study registered as NCT06652633 by Lakefront Biotherapeutics NV, with 546 participants planned, started 2024-09-09 and due to reach its primary completion in 2039-07. Interventions recorded: GLPG CAR T-cell therapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06652633","url":"https://clinicaltrials.gov/study/NCT06652633"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["galapagos"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06652633","phase":"3","setting":"A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies","sponsor":"Lakefront Biotherapeutics NV","started":"2024-09-09","startedType":"actual","enrolled":546,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03435796","kind":"trial","name":"Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells","aka":[],"tldr":"A phase 2/3 trial of Gene-modified (GM) T cell therapy in advanced solid tumours, run by Celgene, now recruiting.","summary":"Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells is a phase 2/3 interventional study registered as NCT03435796 by Celgene, with 1541 participants planned, started 2018-07-19 and due to reach its primary completion in 2036-11-30. Interventions recorded: Gene-modified (GM) T cell therapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03435796","url":"https://clinicaltrials.gov/study/NCT03435796"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03435796","phase":"2/3","setting":"Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells","sponsor":"Celgene","started":"2018-07-19","startedType":"actual","enrolled":1541,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03486873","kind":"trial","name":"Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pemb","aka":[],"tldr":"A phase 3 trial of Favezelimab run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) is a phase 3 interventional study registered as NCT03486873 by Merck Sharp & Dohme LLC, with 3500 participants planned, started 2018-08-21. Conditions listed: Solid Tumors, Hematologic Malignancies. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03486873","url":"https://clinicaltrials.gov/study/NCT03486873"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","lag3-blockade"],"targets":[],"drugs":["favezelimab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03486873","phase":"3","setting":"A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab","sponsor":"Merck Sharp & Dohme LLC","started":"2018-08-21","startedType":"actual","enrolled":3500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07162181","kind":"trial","name":"Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers","aka":[],"tldr":"A phase 2 trial of Pirtobrutinib in non-hodgkin lymphoma, run by Eli Lilly and Company, active and no longer recruiting.","summary":"Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers is a phase 2 interventional study registered as NCT07162181 by Eli Lilly and Company, with 13 participants planned, started 2025-08-07 and due to reach its primary completion in 2030-05. Interventions recorded: Pirtobrutinib. Conditions listed: Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, B-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07162181","url":"https://clinicaltrials.gov/study/NCT07162181"}],"tags":["ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["pirtobrutinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07162181","phase":"2","setting":"Long-Term Safety of Pirtobrutinib in Participants From Study J2N-MC-JZNJ With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma","sponsor":"Eli Lilly and Company","started":"2025-08-07","startedType":"actual","enrolled":13,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01761968","kind":"trial","name":"Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms","aka":[],"tldr":"A phase 2 trial of Givinostat in myeloproliferative neoplasms, run by Italfarmaco, active and no longer recruiting.","summary":"Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms is a phase 2 interventional study registered as NCT01761968 by Italfarmaco, with 90 participants enrolled, started 2013-03 and due to reach its primary completion in 2026-12. Interventions recorded: givinostat.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01761968","url":"https://clinicaltrials.gov/study/NCT01761968"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms"],"sections":[],"technologies":[],"targets":[],"drugs":["givinostat"],"companies":["italfarmaco"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01761968","phase":"2","setting":"Long-term Study Evaluating the Effect of Givinostat in Patients With JAK2V617F Positive Chronic Myeloproliferative Neoplasms","sponsor":"Italfarmaco","started":"2013-03","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06858410","kind":"trial","name":"Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma","aka":[],"tldr":"A phase 3 trial of lorlatinib in lung cancer, run by Guangdong Association of Clinical Trials, not yet recruiting.","summary":"Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma is a phase 3, randomised interventional study registered as NCT06858410 by Guangdong Association of Clinical Trials, with a registry enrolment figure of 36 participants, started 2025-03 and due to reach its primary completion in 2030-03. Interventions recorded: lorlatinib; concurrent/sequential platinum-based chemoradiotherapy. Conditions listed: Neoadjuvant Non-Small Cell Lung Cancer. Primary outcome: Progression Free Survival (PFS). Lung eligibility wording from the registry: \"* Study Population: Patients with histologically or cytologically confirmed diagnosis of ALK-positive, lung adenocarcinoma who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer \\[IASLC\\])\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06858410","url":"https://clinicaltrials.gov/study/NCT06858410"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["alk-positive-nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["imrt-igrt","kinase-inhibitors"],"targets":[],"drugs":["lorlatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06858410","phase":"3","setting":"A Randomized, Open-label, Multicenter, Phase III Study of Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy As Definitive Treatment in Patients with Locally Advanced, Unresectable Stage III ALK Positive Lung Adenocarcinoma","sponsor":"Guangdong Association of Clinical Trials","started":"2025-03","startedType":"estimated","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"lotis-2","kind":"trial","name":"LOTIS-2","aka":[],"tldr":"LOTIS-2 was the pivotal study for loncastuximab, a CD19 ADC with a DNA-crosslinking payload.","summary":"LOTIS-2, trial NCT03589469 sponsored by ADC Therapeutics and reported in 2021, was the pivotal single-arm study for loncastuximab tesirine, a CD19 antibody-drug conjugate with a DNA-crosslinking pyrrolobenzodiazepine payload, in relapsed or refractory diffuse large B-cell lymphoma after at least two lines. In 145 patients the objective response rate was 48 percent with complete responses in 24 percent and durable responses, while oedema, effusions, photosensitivity and liver enzyme rises are class effects of the payload. OnCo links it to lymphoma and loncastuximab tesirine. The confirmatory LOTIS-5 trial of loncastuximab with rituximab against rituximab-gemcitabine-oxaliplatin will show whether the drug improves on chemotherapy, which is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03589469","url":"https://clinicaltrials.gov/study/NCT03589469"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["zynlonta"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03589469","phase":"2","setting":"R/R DLBCL after ≥2 lines: loncastuximab tesirine (single arm)","sponsor":"ADC Therapeutics","result":"ORR 48%, CR 24%.","started":"2018-08-01","startedType":"actual","yearReported":2021,"enrolled":145,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Loncastuximab tesirine","n":145,"value":48.3}],"source":"https://doi.org/10.1016/S1470-2045(21)00139-X"}]},{"id":"lotus","kind":"trial","name":"LOTUS","aka":[],"tldr":"LOTUS was the small trial that made the AKT-blocking tablet ipatasertib look promising in triple-negative breast cancer: added to paclitaxel it delayed progression by about six weeks. The larger IPATunity130 trial then failed to confirm it.","summary":"LOTUS (NCT02162719) randomised 124 women with measurable, untreated inoperable locally advanced or metastatic triple-negative breast cancer between September 2014 and February 2016 to paclitaxel 80 mg/m2 on days 1, 8 and 15 with ipatasertib 400 mg or placebo daily on days 1 to 21 of 28, stratified by prior neoadjuvant or adjuvant therapy, chemotherapy-free interval and PTEN status. The co-primary endpoints were progression-free survival in the intention-to-treat and PTEN-low populations. Median progression-free survival was 6.2 versus 4.9 months (stratified hazard ratio 0.60, 95 percent confidence interval 0.37 to 0.98, p 0.037) overall and 6.2 versus 3.7 months in the 48 patients with PTEN-low tumours (hazard ratio 0.59, 0.26 to 1.32, p 0.18); the largest effect was in tumours with PIK3CA, AKT1 or PTEN alterations, the group IPATunity130 then selected. Grade 3 or worse diarrhoea occurred in 23 percent of ipatasertib-treated patients against none on placebo. Its result, with PAKT for capivasertib, launched the two phase 3 AKT-inhibitor trials (IPATunity130, CAPItello-290) that both failed, so LOTUS is now read as an example of a phase 2 signal in a biomarker subgroup that did not replicate.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02162719","url":"https://clinicaltrials.gov/study/NCT02162719"},{"label":"Kim et al., Lancet Oncology 2017: ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic TNBC (LOTUS)","url":"https://doi.org/10.1016/S1470-2045(17)30450-3"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["pi3k-akt-mtor-inhibitors","cytotoxic-chemotherapy"],"targets":["akt","pten","pik3ca"],"drugs":["ipatasertib","paclitaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":["pi3k-akt-mtor"],"terms":[],"trials":["ipatunity130","pakt","nct03997123"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02162719","phase":"2","setting":"Untreated inoperable locally advanced or metastatic triple-negative breast cancer: first-line paclitaxel with ipatasertib or placebo, 44 hospitals in eight countries","sponsor":"Genentech","result":"PFS 6.2 vs 4.9 months (HR 0.60, p 0.037); PTEN-low 6.2 vs 3.7 months (HR 0.59, p 0.18). Not confirmed by IPATunity130.","started":"2014-08-19","startedType":"actual","yearReported":2017,"enrolled":124,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival, intention to treat","primary":true,"unit":"months","arms":[{"name":"Ipatasertib + paclitaxel","n":62,"value":6.2},{"name":"Placebo + paclitaxel","n":62,"value":4.9}],"hr":0.6,"ci":[0.37,0.98],"p":"0.037","source":"https://doi.org/10.1016/S1470-2045(17)30450-3"},{"endpoint":"Progression-free survival, PTEN-low tumours","primary":true,"unit":"months","arms":[{"name":"Ipatasertib + paclitaxel","value":6.2},{"name":"Placebo + paclitaxel","value":3.7}],"hr":0.59,"ci":[0.26,1.32],"p":"0.18","source":"https://doi.org/10.1016/S1470-2045(17)30450-3"}],"replication":"Not replicated: IPATunity130 cohort A (PIK3CA/AKT1/PTEN-altered, 255 patients) showed no progression-free or overall survival benefit."},{"id":"nct07050043","kind":"trial","name":"Low Dose Nivolumab With Chemotherapy vs Standard Chemotherapy as First-Line Treatment in Advanced or Metastatic NSCLC","aka":["LEDANG"],"tldr":"A phase 3 trial in lung cancer, run by Dr Arvindran A/L Alaga, now recruiting.","summary":"Low Dose Nivolumab With Chemotherapy vs Standard Chemotherapy as First-Line Treatment in Advanced or Metastatic NSCLC is a phase 3, randomised interventional study registered as NCT07050043 by Dr Arvindran A/L Alaga, with a registry enrolment figure of 123 participants, started 2025-05-19 and due to reach its primary completion in 2030-12-31. Interventions recorded: Nivolumab 40mg; Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel. Conditions listed: NSCLC (Non-small Cell Lung Carcinoma); First Line Therapy; Locally Advanced/Metastatic NSCLC. Primary outcome: Progression Free Survival (PFS). Lung eligibility wording from the registry: \"Histologically confirmed, treatment naïve, locally advanced, or metastatic (stage IIIB - IV (per AJCC version 8), squamous or non-squamous NSCLC with documented PD-L1 expression and is not eligible for definitive chemo-radiation curative therapy and surgery\". Sites: Malaysia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07050043","url":"https://clinicaltrials.gov/study/NCT07050043"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07050043","phase":"3","setting":"A Phase III RCT Comparing Low Dose Immunotherapy (Nivolumab) Combined With Standard Chemotherapy vs Standard Chemotherapy as First-line Treatment in Patients With Locally Advanced or Metastatic NSCLC","sponsor":"Dr Arvindran A/L Alaga","started":"2025-05-19","startedType":"actual","enrolled":123,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07576725","kind":"trial","name":"Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial","aka":["AFFORD IO"],"tldr":"A phase 2 trial of nivolumab in colorectal cancer, run by Fred Hutchinson Cancer Center, not yet recruiting.","summary":"Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial is a phase 2, interventional study registered as NCT07576725 by Fred Hutchinson Cancer Center, with a registry enrolment figure of 50 participants, started 2026-12-01 and due to reach its primary completion in 2029-08-31. Interventions recorded: Biospecimen Collection; Computed Tomography; Magnetic Resonance Imaging; Nivolumab. Conditions listed: Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8; Hodgkin Lymphoma; Kaposi Sarcoma; Metastatic Acral Lentiginous Melanoma; Metastatic Basal Cell Carcinoma; Metastatic Cervical Carcinoma; Metastatic Clear Cell Renal Cell Carcinoma; Metastatic Colorectal Carcinoma; Metastatic Cutaneous Melanoma; Metastatic Head and Neck Squamous Cell Carcinoma; Metastatic Kaposi Sarcoma; Metastatic Lung Non-Small Cell Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Merkel Cell Carcinoma; Metastatic Mucosal Melanoma; Metastatic Skin Squamous Cell Carcinoma; Metastatic Urothelial Carcinoma; Stage III Cervical Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8; Stage III Lung Cancer AJCC v8; Stage III Renal Cell Cancer AJCC v8; Stage IV Cervical Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8; Unresectable Acral Lentiginous Melanoma; Unresectable Basal Cell Carcinoma; Unresectable Cervical Carcinoma; Unresectable Clear Cell Renal Cell Carcinoma; Unresectable Colorectal Carcinoma; Unresectable Cutaneous Melanoma; Unresectable Head and Neck Squamous Cell Carcinoma; Unresectable Lung Non-Small Cell Carcinoma; Unresectable Malignant Solid Neoplasm; Unresectable Merkel Cell Carcinoma; Unresectable Mucosal Melanoma; Unresectable Skin Squamous Cell Carcinoma; Unresectable Urothelial Carcinoma. Primary outcome: Objective response. Colorectal eligibility wording from the registry: \"* Colorectal cancer with high microsatellite instability (MSI) or mismatch repair deficiency\". Sites: Uganda. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07576725","url":"https://clinicaltrials.gov/study/NCT07576725"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07576725","phase":"2","setting":"AFFORD IO: A Phase 2 Trial of Low Dose, Reduced Frequency Nivolumab (Anti-PD-1 Antibody) in Patients With Unresectable or Metastatic Cancer","sponsor":"Fred Hutchinson Cancer Center","started":"2026-12-01","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07561060","kind":"trial","name":"Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy","aka":["TNTIT"],"tldr":"A phase 1/2 trial of tislelizumab, capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Fudan University, now recruiting.","summary":"Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy is a phase 1/2, interventional study registered as NCT07561060 by Fudan University, with a registry enrolment figure of 50 participants, started 2024-01-01 and due to reach its primary completion in 2027-12. Interventions recorded: Tislelizumab; Capecitabine; Oxaliplatin; Capecitabine. Conditions listed: Rectal Cancer. Primary outcome: Complete Response rate (CR rate). Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07561060","url":"https://clinicaltrials.gov/study/NCT07561060"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["tislelizumab","capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07561060","phase":"1/2","setting":"A Single-arm, Multicenter, Phase II Clinical Study of Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy in Resectable Low Rectal Cancer","sponsor":"Fudan University","started":"2024-01-01","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07542262","kind":"trial","name":"Low-dose Immunotherapy in Metastatic and Locally Advanced Colorectal and Gastric MSI/dMMR Cancers","aka":["NIVO402025"],"tldr":"A phase 2 trial in colorectal cancer, run by Blokhin's Russian Cancer Research Center, now recruiting.","summary":"Low-dose Immunotherapy in Metastatic and Locally Advanced Colorectal and Gastric MSI/dMMR Cancers is a phase 2, randomised interventional study registered as NCT07542262 by Blokhin's Russian Cancer Research Center, with a registry enrolment figure of 128 participants, started 2025-06-03 and due to reach its primary completion in 2028-03-30. Interventions recorded: Low-dose nivolumab; Low-dose nivolumab with/without chemotherapy; Low-dose nivolumab combined with chemotherapy. Conditions listed: Colorectal Cancer; Gastric Cancer. Primary outcome: Pathological complete response (pCR) - for M0; One-year progression-free survival (PFS) - for M1. Colorectal eligibility wording from the registry: \"* Histologically confirmed adenocarcinoma of the colon/rectum/stomach;\". Sites: Russia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07542262","url":"https://clinicaltrials.gov/study/NCT07542262"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07542262","phase":"2","setting":"Phase II Open-lable Single-center Clinical Study of the Efficacy and Safety of Low-dose Immunotherapy in the Treatment of Patients With Metastatic and Locally Advanced Colorectal and Gastric Cancers With Microsatellite Unstable Phenotype (MSI)/Deficiency of Mismatch Repair System (dMMR)","sponsor":"Blokhin's Russian Cancer Research Center","started":"2025-06-03","startedType":"actual","enrolled":128,"enrolledBasis":"registry","outcomes":[]},{"id":"low-dose-nivolumab-tmh","kind":"trial","name":"Low-dose nivolumab plus metronomic chemotherapy (Tata Memorial)","aka":[],"tldr":"A Mumbai trial that added about one-twentieth of the usual dose of the immunotherapy nivolumab to cheap oral chemotherapy and nearly tripled the share of patients alive at one year.","summary":"151 patients were randomised to triple metronomic chemotherapy (methotrexate, celecoxib and erlotinib) alone or with nivolumab at a flat 20 mg every 3 weeks, a small fraction of the standard 240 mg dose. One-year overall survival rose from 16.3% (95% CI 8.0-27.4) to 43.4% (30.8-55.3) and median overall survival from 6.7 to 10.1 months (hazard ratio 0.545; 95% CI 0.362-0.820; P=0.0036), with no increase in grade 3 or worse adverse events (50% versus 46.1%). The authors proposed the combination as an alternative standard for patients who cannot access full-dose checkpoint inhibitors, which is most of the world. It is the leading example of dose-optimisation trials that make immunotherapy affordable.","status":"positive","asOf":"2026-09-10","links":[{"label":"Patil et al., JCO 2023","url":"https://doi.org/10.1200/JCO.22.01015"}],"tags":[],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc","buccal-mucosa-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":["pd1"],"drugs":["nivolumab","methotrexate"],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":["os"],"trials":[],"people":["patil-vijay","prabhash-kumar","noronha-vanita"],"bottlenecks":["b-dose-optimisation","b-drug-pricing","b-global-access"],"keyPapers":["paper-patil-low-dose-nivolumab-jco-2023"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Recurrent or newly diagnosed advanced head and neck squamous cell carcinoma, palliative intent: triple oral metronomic chemotherapy with or without nivolumab 20 mg every 3 weeks","sponsor":"Tata Memorial Centre","result":"1-year OS 43.4% vs 16.3%; median OS 10.1 vs 6.7 months; HR 0.545.","yearReported":2023,"enrolled":151,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 1 year","primary":true,"unit":"%","arms":[{"name":"Metronomic chemotherapy + low-dose nivolumab","n":76,"value":43.4},{"name":"Metronomic chemotherapy","n":75,"value":16.3}],"hr":0.545,"ci":[0.362,0.82],"p":"0.0036","source":"https://doi.org/10.1200/JCO.22.01015"},{"endpoint":"Median overall survival","unit":"months","arms":[{"name":"Metronomic chemotherapy + low-dose nivolumab","value":10.1},{"name":"Metronomic chemotherapy","value":6.7}],"source":"https://doi.org/10.1200/JCO.22.01015"}]},{"id":"olanzapine-appetite-tmh","kind":"trial","name":"Low-dose olanzapine for cancer anorexia (Tata Memorial)","aka":[],"tldr":"A double-blind trial at Tata Memorial in India randomised 124 patients starting chemotherapy to 2.5 mg of olanzapine, a decades-old tablet costing a few cents a day, or placebo. Six in ten gained more than 5% of their weight against one in ten on placebo, and ASCO listed it in its 2024 cachexia guideline; it was small and single-centre.","summary":"124 patients were randomised, double-blind. The primary endpoint, weight gain over 5% at 12 weeks, was achieved by 60% of patients on olanzapine vs 9% on placebo; appetite improved (visual analogue scale) in 43% vs 13%, and quality of life and chemotherapy toxicity scores favoured olanzapine. Adverse events were minimal at this dose (no excess sedation or metabolic effects over 12 weeks). The trial led ASCO to list low-dose olanzapine as an option in its 2024 cachexia guideline update. It is small, single-centre and short, and did not measure lean mass or survival; a multi-country replication is the obvious next step. Its significance is access: olanzapine is on the WHO essential medicines list and costs a few cents a day.","status":"positive","asOf":"2026-09-08","links":[{"label":"Sandhya et al. (JCO 2023)","url":"https://doi.org/10.1200/JCO.22.01997"}],"tags":[],"related":["idea-bio2-low-dose-olanzapine-appetite","idea-reg-olanzapine-cachexia-global-confirmation","who-essential-medicines"],"cancers":["gastric","nsclc","pancreatic","hcc"],"sections":["nutrition-lifestyle","supportive-care"],"technologies":["cachexia-appetite-pharmacotherapy","antiemetic-therapy","drug-repurposing"],"targets":[],"drugs":[],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":["cachexia","nutrition-impact-symptoms"],"trials":[],"people":["gupta-sudeep"],"bottlenecks":["b-cachexia-supportive","b-generic-repurposing","b-global-access"],"keyPapers":["paper-sandhya-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Untreated, locally advanced or metastatic gastric, hepatopancreaticobiliary or lung cancer starting chemotherapy: olanzapine 2.5 mg daily vs placebo for 12 weeks, plus standard nutritional advice","sponsor":"Tata Memorial Centre","result":"Weight gain over 5%: 60% vs 9%; appetite improvement 43% vs 13%.","yearReported":2023,"enrolled":124,"enrolledBasis":"registry","outcomes":[{"endpoint":"Weight gain greater than 5% at 12 weeks","primary":true,"unit":"%","arms":[{"name":"Olanzapine 2.5 mg","n":63,"value":60},{"name":"Placebo","n":61,"value":9}],"p":"<0.001","source":"https://doi.org/10.1200/JCO.22.01997"}],"replication":"Not yet replicated; consistent with olanzapine's antiemetic trials and with an earlier small Indian randomised trial with megestrol."},{"id":"nct07448142","kind":"trial","name":"Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of pucotenlimab in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT07448142 by Sun Yat-sen University, with a registry enrolment figure of 50 participants, started 2026-03-15 and due to reach its primary completion in 2027-09-01. Interventions recorded: Low-dose radiotherapy; Pucotenlimab; CAPEOX/XELOX. Conditions listed: Colorectal Cancer (CRC). Primary outcome: Complete Response Rate (CR). Colorectal eligibility wording from the registry: \"* Histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07448142","url":"https://clinicaltrials.gov/study/NCT07448142"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["pucotenlimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07448142","phase":"2","setting":"A Randomized, Two-Arm, Open-Label Phase II Trial of Low-Dose Radiotherapy Sensitization Combined With Pucotenlimab and CAPEOX as Neoadjuvant Therapy for pMMR/MSS Locally Advanced Rectal Adenocarcinoma","sponsor":"Sun Yat-sen University","started":"2026-03-15","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07085169","kind":"trial","name":"Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Ruijin Hospital, now recruiting.","summary":"Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC is a phase 2, interventional study registered as NCT07085169 by Ruijin Hospital, with a registry enrolment figure of 50 participants, started 2025-08-01 and due to reach its primary completion in 2027-08-01. Interventions recorded: Trifluridine/tipiracil (TAS-102) plus bevacizumab. Conditions listed: Colo-rectal Cancer; Third-line and Beyond Therapy; TAS 102; Bevacizumab. Primary outcome: 6-month progression-free survival rate. Colorectal eligibility wording from the registry: \"histologically confirmed adenocarcinoma of the colon or rectum\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07085169","url":"https://clinicaltrials.gov/study/NCT07085169"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07085169","phase":"2","setting":"Low-dose Trifluridine/Tipiracil With Bevacizumab in Refractory Metastatic Colorectal Cancer: a Multicenter, Single-arm, Phase 2 Study","sponsor":"Ruijin Hospital","started":"2025-08-01","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"low-pv","kind":"trial","name":"Low-PV","aka":[],"tldr":"Low-PV asked whether even low-risk patients gain from interferon: more of them stayed at the haematocrit target without progression when ropeginterferon was added to phlebotomy.","summary":"Low-PV randomised 127 patients with low-risk PV (under 60 with no prior thrombosis) to phlebotomy plus low-dose aspirin with or without ropeginterferon alfa-2b. At 12 months, 84 percent on ropeginterferon kept a haematocrit at or below 45 percent without progressive disease versus 60 percent with phlebotomy alone (Barbui and colleagues, Lancet Haematology 2021), with fewer phlebotomies and no excess serious harm; the benefit held at two years.","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03003325","url":"https://clinicaltrials.gov/study/NCT03003325"}],"tags":["polycythaemia-vera","mpn"],"related":[],"cancers":["polycythaemia-vera"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["ropeginterferon-alfa-2b"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03003325","phase":"2","setting":"Low-risk polycythaemia vera: ropeginterferon alfa-2b plus phlebotomy versus phlebotomy alone","sponsor":"FROM Research Foundation, Bergamo","result":"Haematocrit at or below 45% without progression at 12 months: 84% vs 60%.","started":"2017-02-02","startedType":"actual","yearReported":2021,"enrolled":127,"enrolledBasis":"registry","outcomes":[{"endpoint":"Response at 12 months","primary":true,"unit":"%","arms":[{"name":"Ropeginterferon + phlebotomy","n":64,"value":84},{"name":"Phlebotomy alone","n":63,"value":60}]}]},{"id":"nct07391566","kind":"trial","name":"LPM6690176 in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation","aka":[],"tldr":"A phase 1/2 trial of bevacizumab (glioblastoma use) and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by Luye Pharma Group Ltd., not yet recruiting.","summary":"LPM6690176 in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation is a phase 1/2, interventional study registered as NCT07391566 by Luye Pharma Group Ltd., with a registry enrolment figure of 99 participants, started 2026-03-31 and due to reach its primary completion in 2028-12-31. Interventions recorded: LPM6690176; Bevacizumab; FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan). Conditions listed: Metastatic Colorectal Cancer (mCRC). Primary outcome: Phase Ib: Dose-limiting toxicities (DLTs); Phase Ib: Maximum tolerated dose (MTD); Phase 1b: Recommended Phase 2 Dose (RP2D). Colorectal eligibility wording from the registry: \"Histologically confirmed metastatic colorectal cancer (CRC) with RAS mutation;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07391566","url":"https://clinicaltrials.gov/study/NCT07391566"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["bevacizumab-glioma","folfiri"],"companies":["luye-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07391566","phase":"1/2","setting":"Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of LPM6690176 Capsules in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation","sponsor":"Luye Pharma Group Ltd.","started":"2026-03-31","startedType":"estimated","enrolled":99,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07357519","kind":"trial","name":"Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)","aka":[],"tldr":"A phase 1/2 trial of LNTH2403 Phase 1 dose in osteosarcoma, run by Lantheus Medical Imaging, now recruiting.","summary":"Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy) is a phase 1/2 interventional study registered as NCT07357519 by Lantheus Medical Imaging, with 55 participants planned, started 2026-02-03 and due to reach its primary completion in 2027-08. Interventions recorded: LNTH2403 Phase 1 dose and Phase 2; LNTH2403 a single agent recommended phase 2 dose (RP2D)..","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07357519","url":"https://clinicaltrials.gov/study/NCT07357519"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["osteosarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["lantheus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07357519","phase":"1/2","setting":"A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, -Radiation Dosimetry, and Preliminary Anti-Neoplastic Activity of LNTH-2403, a LRRC15-targeted 177Lutetium-labeled Monoclonal Antibody, in Participants With Relapsed / Refractory Osteosarcoma","sponsor":"Lantheus Medical Imaging","started":"2026-02-03","startedType":"actual","enrolled":55,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07405736","kind":"trial","name":"Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07405736 by Sun Yat-sen University, with a registry enrolment figure of 124 participants, started 2026-02-24 and due to reach its primary completion in 2027-06-01. Interventions recorded: maintenance therapy plus lubiprostone; maintenance therapy. Conditions listed: Colorectal Cancer Metastatic; Peritoneal (Metastatic) Cancer; Peritoneal Metastasis; Colorectal Cancer (CRC); MSS Metastatic Colorectal Cancer. Primary outcome: 1-year Progression-Free Survival (PFS) Rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed colon/rectal adenocarcinoma with molecular status confirmed as pMMR or MSS\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07405736","url":"https://clinicaltrials.gov/study/NCT07405736"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07405736","phase":"2","setting":"Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer, A Randomized Controlled Phase II Study","sponsor":"Sun Yat-sen University","started":"2026-02-24","startedType":"estimated","enrolled":124,"enrolledBasis":"registry","outcomes":[]},{"id":"lume-lung-1","kind":"trial","name":"LUME-Lung 1","aka":[],"tldr":"An oral drug against three angiogenic receptors added to second-line chemotherapy; it worked, but only in adenocarcinoma, which is how it is licensed.","summary":"LUME-Lung 1 randomised 1,314 patients at 211 centres in 27 countries between December 2008 and February 2011 to docetaxel with nintedanib (655) or docetaxel with placebo (659), stratified by performance status, previous bevacizumab, histology and brain metastases. Overall survival was tested in a prespecified stepwise order: first in patients with adenocarcinoma who progressed within nine months of starting first-line therapy, then in all adenocarcinoma patients, then in everyone.\n\nThe primary endpoint was met: median progression-free survival 3.4 months (95 percent confidence interval 2.9 to 3.9) against 2.7 months (2.6 to 2.8), hazard ratio 0.79 (0.68 to 0.92, p=0.0019). Overall survival was significant in the adenocarcinoma populations of the hierarchy but not in the whole population, which is why the EU licence, granted in 2014, is restricted to adenocarcinoma after first-line chemotherapy and why there is no United States approval in lung cancer.\n\nIn England NICE TA347 (22 July 2015) recommends nintedanib with docetaxel for adenocarcinoma that has progressed after first-line chemotherapy, with the patient access scheme discount. Nintedanib's other life is as a treatment for idiopathic pulmonary fibrosis, for which it was approved in the United States in 2014.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00805194","url":"https://clinicaltrials.gov/study/NCT00805194"},{"label":"LUME-Lung 1 (Lancet Oncology 2014)","url":"https://doi.org/10.1016/S1470-2045(13)70586-2"},{"label":"NICE TA347: nintedanib for previously treated non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta347"}],"tags":[],"related":[],"cancers":["lung-adenocarcinoma","nsclc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors","cytotoxic-chemotherapy"],"targets":["vegf"],"drugs":["nintedanib","docetaxel"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":[],"trials":["revel"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00805194","phase":"3","setting":"Stage IIIB or IV recurrent non-small-cell lung cancer progressing after first-line chemotherapy: docetaxel 75 mg/m2 on day 1 with nintedanib 200 mg twice daily or placebo on days 2 to 21, every three weeks, with progression-free survival by independent central review as the primary endpoint and a stepwise overall survival hierarchy","sponsor":"Boehringer Ingelheim","result":"Median progression-free survival 3.4 against 2.7 months (hazard ratio 0.79, p=0.0019); overall survival significant in the adenocarcinoma populations of the prespecified hierarchy but not overall.","started":"2008-12-03","startedType":"actual","yearReported":2014,"enrolled":1314,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (independent central review)","primary":true,"unit":"months","arms":[{"name":"Nintedanib with docetaxel","n":655,"value":3.4},{"name":"Placebo with docetaxel","n":659,"value":2.7}],"hr":0.79,"ci":[0.68,0.92],"p":"0.0019","source":"https://doi.org/10.1016/S1470-2045(13)70586-2"}]},{"id":"lume-meso","kind":"trial","name":"LUME-Meso","aka":[],"tldr":"LUME-Meso randomised 458 patients with epithelioid pleural mesothelioma to first-line cisplatin and pemetrexed with nintedanib or placebo. The phase 2 progression signal for the multi-kinase inhibitor vanished in phase 3, with no delay in progression and no gain in life, a lesson in the unreliability of small phase 2 signals in this disease.","summary":"LUME-Meso, trial NCT01907100 sponsored by Boehringer Ingelheim and reported in 2019, found that the phase 2 progression signal for the multi-kinase inhibitor nintedanib vanished in phase 3. It randomised 458 patients with epithelioid pleural mesothelioma to nintedanib or placebo with first-line cisplatin and pemetrexed and found no difference in progression-free survival and no survival benefit. OnCo links it to mesothelioma, nintedanib and pemetrexed. The record treats it as a lesson in the unreliability of small randomised phase 2 progression signals in mesothelioma, and why such signals so often fail to replicate in this disease is the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01907100","url":"https://clinicaltrials.gov/study/NCT01907100"}],"tags":["lesson:phase-2-pfs-signal"],"related":[],"cancers":["mesothelioma"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["nintedanib","pemetrexed"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01907100","phase":"2/3","setting":"Epithelioid pleural mesothelioma, first line: cisplatin-pemetrexed ± nintedanib","sponsor":"Boehringer Ingelheim","result":"PFS HR 1.01, negative.","started":"2013-09-19","startedType":"actual","yearReported":2019,"enrolled":458,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Nintedanib + chemotherapy","n":229,"value":6.8},{"name":"Placebo + chemotherapy","n":229,"value":7}],"hr":1.01,"ci":[0.79,1.3],"source":"https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(19)30139-0/fulltext"}]},{"id":"lumina","kind":"trial","name":"LUMINA","aka":[],"tldr":"LUMINA used tumour biology, not just age, to pick women who can skip breast radiotherapy: with a luminal A profile and endocrine therapy, local recurrence at five years was about two percent.","summary":"LUMINA was a single-arm prospective study of 500 women aged 55 or older with grade 1 or 2 T1N0 luminal A breast cancer (oestrogen and progesterone receptor-positive, HER2-negative, Ki67 of 13.25 percent or less) who had breast-conserving surgery and endocrine therapy and no radiotherapy. Five-year local recurrence was 2.3 percent, 90 percent confidence interval 1.3 to 3.8 (Whelan and colleagues, New England Journal of Medicine 2023;389:612 to 619), supporting biomarker-based omission.","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01791829","url":"https://clinicaltrials.gov/study/NCT01791829"},{"label":"Whelan et al., New England Journal of Medicine 2023;389:612 to 619: omitting radiotherapy after breast-conserving surgery in luminal A breast cancer","url":"https://doi.org/10.1056/NEJMoa2302344"}],"tags":["radiation-wave2"],"related":[],"cancers":["breast-hr-positive","breast-cancer"],"sections":[],"technologies":["active-surveillance"],"targets":[],"drugs":[],"companies":["ocog"],"institutions":[],"pathways":[],"terms":["radiotherapy-omission-early-breast-cancer"],"trials":["calgb-9343","prime-ii"],"people":[],"bottlenecks":[],"keyPapers":["paper-cowan-lancet-oncol","paper-lumina-n-engl-j-med-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01791829","phase":"2","setting":"Women aged 55 or over with small luminal A breast cancer after breast-conserving surgery and endocrine therapy: radiotherapy omitted","sponsor":"Ontario Clinical Oncology Group","result":"5-year local recurrence 2.3% without radiotherapy in luminal A disease.","started":"2013-07","startedType":"actual","yearReported":2023,"enrolled":500,"enrolledBasis":"registry","outcomes":[{"endpoint":"Local recurrence at 5 years","primary":true,"unit":"%","arms":[{"name":"Endocrine therapy, no radiotherapy","n":500,"value":2.3}]}]},{"id":"luminosity","kind":"trial","name":"LUMINOSITY","aka":[],"tldr":"The single-arm study behind the first c-Met-directed antibody-drug conjugate approval in lung cancer: tumours shrank in about a third of patients whose cancers carried high c-Met protein, with eye and nerve side effects to watch.","summary":"LUMINOSITY, trial NCT03539536 sponsored by AbbVie and published in the Journal of Clinical Oncology in 2024, gave telisotuzumab vedotin to previously treated patients with non-squamous, EGFR wild-type non-small-cell lung cancer whose tumours overexpressed c-Met protein on immunohistochemistry. The objective response rate was 28.6% overall, 34.6% in the c-Met high group and 22.9% in the intermediate group, with peripheral sensory neuropathy, peripheral oedema and keratitis among the notable side effects. The c-Met high results supported the 2025 US accelerated approval of Emrelis, the first c-Met-directed ADC in lung cancer; the confirmatory phase 3 trial TeliMET NSCLC-01 is ongoing.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT03539536","url":"https://clinicaltrials.gov/study/NCT03539536"},{"label":"Camidge et al., Telisotuzumab vedotin monotherapy in previously treated c-Met protein-overexpressing non-squamous NSCLC: LUMINOSITY (Journal of Clinical Oncology 2024)","url":"https://doi.org/10.1200/JCO.24.00720"}],"tags":[],"related":[],"cancers":["nsclc","met-altered-nsclc"],"sections":[],"technologies":["adc"],"targets":["met"],"drugs":["telisotuzumab-vedotin"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-luminosity-j-clin-oncol-2024","paper-luminosity-jto-clin-res-rep-2026-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03539536","phase":"2","setting":"Previously treated c-Met protein-overexpressing, EGFR wild-type non-squamous NSCLC: telisotuzumab vedotin single arm","sponsor":"AbbVie","result":"ORR 28.6% overall; 34.6% in c-Met high, 22.9% in c-Met intermediate.","started":"2018-10-10","startedType":"actual","yearReported":2024,"enrolled":270,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (independent review)","primary":true,"unit":"%","arms":[{"name":"Telisotuzumab vedotin, c-Met high","n":78,"value":34.6},{"name":"Telisotuzumab vedotin, c-Met intermediate","n":83,"value":22.9}],"source":"https://doi.org/10.1200/JCO.24.00720"}]},{"id":"lummicar-1","kind":"trial","name":"LUMMICAR STUDY 1","aka":[],"tldr":"The Chinese trial behind zevor-cel's approval for multiple myeloma, showing deep and lasting responses with a fully human BCMA CAR-T.","summary":"Phase 1/2 single-arm study at Chinese centres; the phase 2 report (Experimental Hematology and Oncology 2025) described high overall and complete response rates, deep minimal residual disease negativity and predominantly low-grade cytokine release syndrome. Basis of NMPA approval in February 2024. A parallel North American study (LUMMICAR STUDY 2) was run by CARsgen before it refocused on China.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03975907","url":"https://clinicaltrials.gov/study/NCT03975907"},{"label":"Exp Hematol Oncol 2025","url":"https://doi.org/10.1186/s40164-025-00710-y"}],"tags":["china"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["car-t"],"targets":["bcma"],"drugs":["zevorcabtagene-autoleucel"],"companies":["carsgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-chen-exp-hematol-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03975907","phase":"1/2","setting":"Relapsed or refractory multiple myeloma after three or more lines, China: single-arm study of zevorcabtagene autoleucel (CT053)","sponsor":"CARsgen Therapeutics","started":"2019-06-10","startedType":"actual","yearReported":2024,"enrolled":102,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (independent review committee)","primary":true,"unit":"%","arms":[{"name":"Zevorcabtagene autoleucel","n":102,"value":92.2,"note":"102 infused of 125 apheresed; median follow-up 20.3 months; DOR, PFS and OS not mature"}],"ci":[85.13,96.55],"source":"https://doi.org/10.1186/s40164-025-00710-y"},{"endpoint":"Stringent complete response","unit":"%","arms":[{"name":"Zevorcabtagene autoleucel","n":102,"value":68.6,"note":"A further 2.9% reached complete response"}],"source":"https://doi.org/10.1186/s40164-025-00710-y"},{"endpoint":"Cytokine release syndrome, any grade","unit":"%","arms":[{"name":"Zevorcabtagene autoleucel","n":102,"value":90.2,"note":"Grade 3-4 in 6.9%; ICANS in 2 patients, both grade 1"}],"source":"https://doi.org/10.1186/s40164-025-00710-y"}],"replication":"Single-arm phase 2 at 23 Chinese centres (patients with prior BCMA-directed or CAR-T therapy excluded). Consistent with FUMANBA-1 (eque-cel, ORR 96%) and with the North American LUMMICAR STUDY 2 dose-finding cohort; no randomised trial against standard regimens."},{"id":"nct06216301","kind":"trial","name":"LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC","aka":["LUNAR-2"],"tldr":"A phase 3 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by NovoCure GmbH, now recruiting.","summary":"LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC is a phase 3 interventional study registered as NCT06216301 by NovoCure GmbH, with 734 participants planned, started 2024-07-31 and due to reach its primary completion in 2028-10. Interventions recorded: NovoTTF-200T, Pembrolizumab, Platinum based chemotherapy. Conditions listed: Metastatic Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06216301","url":"https://clinicaltrials.gov/study/NCT06216301"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["novocure"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06216301","phase":"3","setting":"LUNAR-2: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab and Platinum-based Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer","sponsor":"NovoCure GmbH","started":"2024-07-31","startedType":"actual","enrolled":734,"enrolledBasis":"registry","outcomes":[]},{"id":"lung-art","kind":"trial","name":"Lung ART","aka":["LungART","IFCT-0503"],"tldr":"The trial that ended twenty years of argument about radiotherapy to the mediastinum after lung cancer surgery: it does not help, and it damages the heart.","summary":"Postoperative radiotherapy after resection of non-small-cell lung cancer had been contentious since a 1998 meta-analysis found it harmful in N0 and N1 disease but could not settle its effect in N2 disease. Lung ART recruited 501 patients with complete resection, nodal exploration and proven N2 involvement from 64 hospitals in France, the United Kingdom, Germany, Switzerland and Belgium, and randomised them to mediastinal radiotherapy at 54 Gy in 27 or 30 fractions or to no radiotherapy. Three-dimensional conformal planning was mandatory. Ninety-one percent were staged with FDG PET, and previous neoadjuvant or adjuvant chemotherapy was allowed.\n\nThe trial did not meet its primary endpoint: three-year disease-free survival was not significantly improved. Mediastinal recurrence fell, but late cardiopulmonary toxicity rose, and the two cancelled out.\n\nThe practical result is that postoperative radiotherapy is no longer offered routinely for N2 disease after a complete resection, and the R1 or R2 margin, not the node, is now the reason to give it. Lung ART is also an argument for modern planning: the harm signal was smaller than in the older series, but not small enough.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00410683","url":"https://clinicaltrials.gov/study/NCT00410683"},{"label":"Lung ART (Lancet Oncology 2022)","url":"https://doi.org/10.1016/S1470-2045(21)00606-9"}],"tags":[],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["curative-intent"],"trials":["anita"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00410683","phase":"3","setting":"Completely resected non-small-cell lung cancer with cytologically or histologically proven N2 mediastinal involvement: mediastinal postoperative radiotherapy, 54 Gy in 27 or 30 daily fractions, versus no postoperative radiotherapy, with disease-free survival at three years as the primary endpoint","sponsor":"Institut Gustave Roussy","result":"Postoperative mediastinal radiotherapy did not improve three-year disease-free survival in completely resected N2 disease; mediastinal relapse fell but cardiopulmonary toxicity rose.","started":"2007-02","startedType":"actual","yearReported":2021,"enrolled":501,"enrolledBasis":"randomised","enrolledNote":"501 patients were randomised and reported; the ClinicalTrials.gov record for NCT00410683 gives 500.","outcomes":[]},{"id":"nct07355231","kind":"trial","name":"Lung Functional Avoidance Radiotherapy Using Hyperpolarized Xenon MRI","aka":["GuidedRT"],"tldr":"A phase 1/2 trial in lung cancer, run by Xemed LLC, not yet recruiting.","summary":"Lung Functional Avoidance Radiotherapy Using Hyperpolarized Xenon MRI is a phase 1/2, interventional study registered as NCT07355231 by Xemed LLC, with a registry enrolment figure of 10 participants, started 2027-03-01 and due to reach its primary completion in 2028-02-29. Interventions recorded: Hyperpolarized xenon MRI. Conditions listed: Carcinoma, Non-Small-Cell Lung. Primary outcome: Changes in DLCO at 6-month post RT treatment.. Lung eligibility wording from the registry: \"* Patients over 18 years with a diagnosis of non-small lung cancer and planned for a definitive course of radiation therapy\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07355231","url":"https://clinicaltrials.gov/study/NCT07355231"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07355231","phase":"1/2","setting":"Lung Functional Avoidance Radiotherapy Using Hyperpolarized Xenon MRI","sponsor":"Xemed LLC","started":"2027-03-01","startedType":"estimated","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"lung-map","kind":"trial","name":"Lung-MAP (SWOG S1400 and S1900)","aka":["Lung Master Protocol","LUNGMAP","Lung-MAP S1400","S1400","S1900"],"tldr":"Lung-MAP is the United States public-private umbrella trial in lung cancer: every patient gets one genomic test and is sent to whichever experimental drug matches their tumour, with the rest joining immunotherapy arms. Its first matched drugs disappointed; its immunotherapy combinations produced the platform's first survival signal.","summary":"Lung-MAP opened in June 2014 as SWOG S1400, the first master protocol run jointly by the National Cancer Institute's cooperative groups, the FDA, Friends of Cancer Research, the Foundation for the NIH and several drug companies. Patients with previously treated stage 4 squamous non-small-cell lung cancer had their tumour sequenced once with Foundation Medicine's panel; those with a matching alteration were assigned to a targeted sub-study and everyone else to a non-match sub-study, each sub-study a phase 2 that could expand seamlessly into phase 3. Roy Herbst and Vassiliki Papadimitrakopoulou led it, with Mary Redman as statistician. In 2019 it became S1900 (NCT03851445), open to all non-small-cell histologies and to patients who had already had immunotherapy.\n\nThe first generation of sub-studies is summarised in the Lancet Oncology in 2020: 1,864 patients were screened and the genotype-matched arms, taselisib for PIK3CA (S1400B), palbociclib for cell-cycle gene amplification (S1400C) and AZD4547 for FGFR alterations (S1400D), all closed for futility with few responses, while durvalumab (S1400A) and durvalumab with tremelimumab after progression on anti-PD-1 therapy (S1400F) gave modest activity. A MET-directed arm of rilotumumab with erlotinib closed early, talazoparib for homologous recombination repair alterations (S1400G) did not meet its bar, and telisotuzumab vedotin for c-MET-positive tumours (S1400K) reported a low response rate. S1400I, the platform's first phase 3, found that adding ipilimumab to nivolumab did not improve survival. The one clearly positive sub-study so far is S1800A, in which ramucirumab plus pembrolizumab improved overall survival against standard of care in patients whose cancer had progressed on both chemotherapy and immunotherapy; the pragmatic phase 3 Pragmatica-Lung (S2302) was opened to confirm it.\n\nWhat Lung-MAP changed was less any one drug than the machinery: a single FDA-agreed screening assay, sub-studies designed to support approval, drug companies entering and leaving one protocol, and, from 2024, published genomic landscapes of squamous lung cancer from the screening data. What it also showed, alongside NCI-MATCH and the National Lung Matrix Trial, is that matching one drug to one mutation in squamous lung cancer rarely produces large responses, which is why the newer sub-studies pair targeted agents with immunotherapy or test combinations.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02154490","url":"https://clinicaltrials.gov/study/NCT02154490"},{"label":"ClinicalTrials.gov NCT03851445","url":"https://clinicaltrials.gov/study/NCT03851445"},{"label":"Herbst et al., Clinical Cancer Research 2015: Lung Master Protocol (Lung-MAP), a biomarker-driven protocol for squamous cell lung cancer","url":"https://doi.org/10.1158/1078-0432.CCR-13-3473"},{"label":"Redman et al., Lancet Oncology 2020: biomarker-driven therapies for previously treated squamous NSCLC (Lung-MAP SWOG S1400)","url":"https://doi.org/10.1016/S1470-2045(20)30475-7"},{"label":"Lung-MAP next-generation sequencing analysis of advanced squamous cell lung cancers, Journal of Thoracic Oncology 2024","url":"https://doi.org/10.1016/j.jtho.2024.07.024"}],"tags":[],"related":[],"cancers":["nsclc","lung-cancer"],"sections":[],"technologies":["cgp","checkpoint-inhibitor","cdk46-inhibitor","parp-inhibitor","adc"],"targets":[],"drugs":["durvalumab","tremelimumab","palbociclib","talazoparib","nivolumab","ipilimumab","telisotuzumab-vedotin","ramucirumab","pembrolizumab","erlotinib","docetaxel"],"companies":["foundation-medicine","swog","ecog-acrin","alliance-oncology","nrg-oncology"],"institutions":["nci"],"pathways":[],"terms":["master-protocol","seamless-adaptive","basket-umbrella-platform"],"trials":["lung-map-s1400i","lung-map-s1800a"],"people":["roy-herbst","karen-kelly"],"bottlenecks":["b-trial-design"],"keyPapers":["paper-kozono-j-thorac-oncol","paper-redman-lancet-oncol","paper-herbst-clin-cancer-res","paper-lung-map-j-thorac-oncol-2019"],"journals":[],"dependsOn":[],"notes":["Registry status on 24 September 2026: Completed (registry record last updated 1 June 2023; primary completion reached 1 April 2022)."],"nct":"NCT02154490","phase":"platform","setting":"Previously treated advanced non-small-cell lung cancer (squamous only until 2019, all histologies since): one genomic screen assigns each patient to a biomarker-matched sub-study or, with no match, to an immunotherapy sub-study","sponsor":"SWOG Cancer Research Network with the National Cancer Institute, Friends of Cancer Research and the Foundation for the NIH","result":"Genotype-matched targeted arms (taselisib, palbociclib, AZD4547) closed for futility; nivolumab plus ipilimumab did not beat nivolumab (S1400I); ramucirumab plus pembrolizumab improved overall survival against standard care (S1800A).","started":"2014-07-08","startedType":"actual","yearReported":2020,"enrolled":1864,"enrolledBasis":"registry","outcomes":[{"endpoint":"Screen Success Rate","primary":true,"unit":"participants","arms":[{"name":"Assigned Participants","n":1404,"value":655,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-01-31), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT02154490?tab=results"}]},{"id":"lung-map-s1400i","kind":"trial","name":"Lung-MAP S1400I: nivolumab with or without ipilimumab","aka":["S1400I","SWOG S1400I"],"tldr":"The first phase 3 to run inside Lung-MAP asked whether adding a second immunotherapy drug, ipilimumab, to nivolumab helps people with squamous lung cancer. It did not: survival was no better and side effects were worse.","summary":"S1400I was the non-match sub-study of Lung-MAP for patients whose tumours carried none of the platform's targetable alterations and who had not yet received immunotherapy. It randomised 275 patients with previously treated squamous non-small-cell lung cancer to nivolumab plus ipilimumab or nivolumab alone, with overall survival as the primary endpoint.\n\nThe trial was stopped for futility at an interim analysis and published in JAMA Oncology in 2021 by Scott Gettinger and colleagues: the combination did not improve overall or progression-free survival or response rate, and grade 3 or worse side effects were more common with ipilimumab. Exploratory analyses did not find a subgroup, including by tumour mutational burden or PD-L1, that clearly benefited.\n\nThe result matters because it was produced quickly inside an existing platform rather than by building a new trial, and because it tempered enthusiasm for doublet checkpoint blockade in squamous lung cancer after CheckMate 227 had shown a benefit in a different setting. Lung-MAP's later immunotherapy sub-studies moved to combinations with other classes, such as ramucirumab in S1800A.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02785952","url":"https://clinicaltrials.gov/study/NCT02785952"},{"label":"Gettinger et al., JAMA Oncology 2021: nivolumab plus ipilimumab vs nivolumab for previously treated stage IV squamous cell lung cancer (Lung-MAP S1400I)","url":"https://doi.org/10.1001/jamaoncol.2021.2209"}],"tags":[],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":["swog"],"institutions":["nci"],"pathways":[],"terms":["master-protocol","basket-umbrella-platform"],"trials":["lung-map"],"people":[],"bottlenecks":[],"keyPapers":["paper-lung-map-s1400i-jama-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02785952","phase":"3","setting":"Previously treated stage 4 squamous non-small-cell lung cancer with no matching biomarker and no prior immunotherapy: nivolumab plus ipilimumab against nivolumab alone","sponsor":"SWOG Cancer Research Network and the National Cancer Institute","result":"Nivolumab plus ipilimumab did not improve survival over nivolumab alone; the trial closed for futility.","started":"2015-12-29","startedType":"actual","yearReported":2021,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab + ipilimumab","n":125,"value":10},{"name":"Nivolumab","n":127,"value":11}],"hr":0.87,"ci":[0.66,1.16],"p":"0.34","source":"https://doi.org/10.1001/jamaoncol.2021.2209"},{"endpoint":"Investigator-assessed progression-free survival","unit":"months","arms":[{"name":"Nivolumab + ipilimumab","value":3.8},{"name":"Nivolumab","value":2.9}],"hr":0.8,"ci":[0.61,1.03],"p":"0.09","source":"https://doi.org/10.1001/jamaoncol.2021.2209"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Nivolumab + ipilimumab","value":18},{"name":"Nivolumab","value":17}],"source":"https://doi.org/10.1001/jamaoncol.2021.2209"}]},{"id":"lung-map-s1800a","kind":"trial","name":"Lung-MAP S1800A: ramucirumab plus pembrolizumab","aka":["S1800A","SWOG S1800A"],"tldr":"In people whose lung cancer had already got past chemotherapy and immunotherapy, the Lung-MAP sub-study S1800A found that a blood-vessel blocker (ramucirumab) plus pembrolizumab helped them live longer than more chemotherapy did. A larger, simpler trial was launched to confirm it.","summary":"S1800A was the first Lung-MAP sub-study designed for patients whose non-small-cell lung cancer had progressed after immune checkpoint therapy, a group with no good standard. It randomised 166 patients to ramucirumab with pembrolizumab or to standard of care (docetaxel with or without ramucirumab, gemcitabine or pemetrexed), with overall survival as the primary endpoint of a phase 2 designed to detect a large signal.\n\nKaren Reckamp and colleagues reported in the Journal of Clinical Oncology in 2022 that median overall survival was 14.5 months with the combination against 11.6 months with standard care, a hazard ratio of 0.69, with fewer severe side effects. Response rates were similar in both arms, so the benefit appeared to come from disease control rather than shrinkage, and progression-free survival was not significantly different.\n\nBecause a phase 2 survival signal in 166 patients is not proof, SWOG and the NCI opened Pragmatica-Lung (S2302), a deliberately simple phase 3 with minimal eligibility rules and data collection, to confirm the result in a population close to routine practice. S1800A also became the model for Lung-MAP's later immunotherapy-combination sub-studies in patients who have already had checkpoint blockade.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03971474","url":"https://clinicaltrials.gov/study/NCT03971474"},{"label":"Reckamp et al., Journal of Clinical Oncology 2022: phase II randomized study of ramucirumab and pembrolizumab versus standard of care in advanced NSCLC previously treated with immunotherapy (Lung-MAP S1800A)","url":"https://doi.org/10.1200/JCO.22.00912"}],"tags":[],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["ramucirumab","pembrolizumab","docetaxel","gemcitabine","pemetrexed"],"companies":["swog"],"institutions":["nci"],"pathways":[],"terms":["master-protocol","basket-umbrella-platform"],"trials":["lung-map"],"people":[],"bottlenecks":[],"keyPapers":["paper-reckamp-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03971474","phase":"2","setting":"Stage 4 non-small-cell lung cancer that has progressed after both platinum chemotherapy and immunotherapy: ramucirumab plus pembrolizumab against investigator's choice of standard chemotherapy","sponsor":"SWOG Cancer Research Network and the National Cancer Institute","result":"Median overall survival 14.5 months with ramucirumab plus pembrolizumab versus 11.6 months with standard of care (hazard ratio 0.69); confirmation sought in the phase 3 Pragmatica-Lung.","started":"2019-05-28","startedType":"actual","yearReported":2022,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Ramucirumab + pembrolizumab","value":14.5},{"name":"Standard of care","value":11.6}],"hr":0.69,"source":"https://doi.org/10.1200/JCO.22.00912"}]},{"id":"lungsearch","kind":"trial","name":"Lung-SEARCH","aka":["LungSEARCH","ISRCTN80745975"],"tldr":"The British trial that tested a cheap, staged alternative to scanning everyone, and found it did not work: more than half the cancers never showed up in the sputum at all.","summary":"Lung-SEARCH asked whether a cheap first test could be used to decide who needs an expensive one. It randomised 1,568 current and former smokers with mild or moderate chronic obstructive pulmonary disease to five years of annual sputum cytology and cytometry, with low-dose CT and autofluorescence bronchoscopy reserved for those with abnormal sputum, or to nothing. Of those screened, 42 of 785 developed lung cancer against 36 of 783 controls. Early-stage disease accounted for 54.8 percent of the screened arm's cancers against 45.2 percent of the control arm's, a difference that did not reach significance.\n\nThe mechanism failed rather than the idea: sputum sensitivity was only 40.5 percent with a cumulative false-positive rate of 32.8 percent, and 55 percent of the cancers had normal sputum throughout. Among people who did have positive sputum, CT was 100 percent sensitive. The authors concluded that the sequential strategy did not lead to a clear stage shift and did not improve the efficiency of screening, which is part of why the UK went to risk-model selection and direct CT instead.","status":"negative","asOf":"2026-09-25","links":[{"label":"European Respiratory Journal 2019","url":"https://europepmc.org/article/MED/31537697"},{"label":"ISRCTN80745975","url":"https://www.isrctn.com/ISRCTN80745975"}],"tags":["uk","screening","lung","negative-trial"],"related":[],"cancers":["nsclc","lung-cancer"],"sections":["early-detection"],"technologies":["low-dose-ct-screening"],"targets":[],"drugs":[],"companies":[],"institutions":["uclh"],"pathways":[],"terms":[],"trials":["ukls"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN80745975","phase":"3","setting":"Five years of annual sputum cytology and cytometry in current and former smokers with mild or moderate chronic obstructive pulmonary disease, with low-dose CT and autofluorescence bronchoscopy only for those whose sputum was abnormal, against no surveillance","sponsor":"University College London, funded by Cancer Research UK","result":"No clear stage shift (54.8 against 45.2 percent early stage, one-sided p = 0.24); sputum sensitivity 40.5 percent with a 32.8 percent cumulative false-positive rate, and 55 percent of cancers had normal sputum throughout.","yearReported":2019,"enrolled":1568,"enrolledBasis":"randomised","enrolledNote":"1,568 were randomised against a target of 1,700 between 2007 and 2011 at ten UK centres.","outcomes":[]},{"id":"lurbinectedin-basket-sclc","kind":"trial","name":"Lurbinectedin basket trial, small-cell lung cancer cohort","aka":["PM1183-B-005-14","Lurbinectedin SCLC basket"],"tldr":"A single-arm study of 105 patients that gave relapsed small-cell lung cancer its first new drug in decades, on a response rate rather than a survival benefit.","summary":"Small-cell lung cancer relapsing after platinum and etoposide had one approved option, topotecan, with a response rate near 15 percent and heavy myelosuppression. Lurbinectedin binds the minor groove of DNA at CG-rich promoter regions and blocks oncogenic transcription; it also depletes tumour-associated macrophages. The basket study recruited from 26 hospitals in six European countries and the United States between October 2015 and January 2019 and treated 105 patients with one previous chemotherapy line at 3.2 mg/m2 every three weeks.\n\nInvestigator-assessed objective response was 35.2 percent (95 percent confidence interval 26.2 to 45.2) at a median follow-up of 17.1 months. Grade 3 to 4 events were haematological: neutropenia 46 percent, leucopenia 29 percent, anaemia 9 percent, thrombocytopenia 7 percent. Serious treatment-related events occurred in 10 percent.\n\nThe FDA granted accelerated approval in 2020. The confirmatory trial, ATLANTIS, which tested lurbinectedin with doxorubicin against topotecan or CAV, missed its overall survival endpoint, so the approval rested on the single-arm data for years; the randomised evidence came from IMforte, on which the FDA approved lurbinectedin with atezolizumab for maintenance treatment of extensive-stage disease on 2 October 2025. Lurbinectedin has no marketing authorisation in the United Kingdom and no NICE appraisal, so it is not available on the NHS.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02454972","url":"https://clinicaltrials.gov/study/NCT02454972"},{"label":"Lurbinectedin SCLC basket cohort (Lancet Oncology 2020)","url":"https://doi.org/10.1016/S1470-2045(20)30068-1"}],"tags":[],"related":[],"cancers":["extensive-stage-sclc","sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["lurbinectedin","topotecan"],"companies":["pharmamar"],"institutions":[],"pathways":[],"terms":["palliative-treatment"],"trials":["atlantis","imforte"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02454972","phase":"2","setting":"Small-cell lung cancer after one previous chemotherapy-containing line, performance status 2 or better, no brain metastases: lurbinectedin 3.2 mg/m2 as a one-hour infusion every three weeks, single arm, with investigator-assessed objective response as the primary endpoint","sponsor":"PharmaMar","result":"Objective response 35.2 percent (37 of 105); grade 3-4 neutropenia in 46 percent.","started":"2015-08-25","startedType":"actual","yearReported":2020,"enrolled":105,"enrolledBasis":"treated","enrolledNote":"105 patients with small-cell lung cancer were enrolled and treated in this cohort; the registry enrolment covers the whole basket study.","outcomes":[{"endpoint":"Objective response rate (investigator assessed)","primary":true,"unit":"%","arms":[{"name":"Lurbinectedin 3.2 mg/m2","n":105,"value":35.2}],"ci":[26.2,45.2],"source":"https://doi.org/10.1016/S1470-2045(20)30068-1"}],"replication":"The confirmatory ATLANTIS trial missed its primary overall survival endpoint; IMforte later provided randomised evidence for lurbinectedin in first-line maintenance with atezolizumab."},{"id":"nct06496048","kind":"trial","name":"Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC","aka":[],"tldr":"A phase 3 trial of Lurbinectedin, FOLFIRI, Topotecan in small-cell lung cancer, run by Luye Pharma Group Ltd., now recruiting.","summary":"Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC is a phase 3 interventional study registered as NCT06496048 by Luye Pharma Group Ltd., with 180 participants planned, started 2024-09-14 and due to reach its primary completion in 2027-12-31. Interventions recorded: Lurbinectedin, Irinotecan, Lurbinectedin, Topotecan. Conditions listed: Relapsed Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06496048","url":"https://clinicaltrials.gov/study/NCT06496048"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["lurbinectedin","folfiri","topotecan"],"companies":["luye-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06496048","phase":"3","setting":"A Phase III, Multicenter, Randomized, Open-label Study of Lurbinectedin As Monotherapy or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed Small-cell Lung Cancer (SCLC)","sponsor":"Luye Pharma Group Ltd.","started":"2024-09-14","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07153055","kind":"trial","name":"Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer","aka":["LOTS"],"tldr":"A phase 1/2 trial of lurbinectedin and osimertinib in lung cancer, run by Misty Shields, now recruiting.","summary":"Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer is a phase 1/2, interventional study registered as NCT07153055 by Misty Shields, with a registry enrolment figure of 16 participants, started 2026-08 and due to reach its primary completion in 2029-04. Interventions recorded: Lurbinectedin; Osimertinib. Conditions listed: Small Cell Lung Cancer ( SCLC ); Transformed Small Cell Lung Cancer. Primary outcome: Grade 3 or dose-limiting toxicities. Lung eligibility wording from the registry: \"Must have a histologically or cytologically confirmed transformation to small cell lung carcinoma/cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07153055","url":"https://clinicaltrials.gov/study/NCT07153055"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["lurbinectedin","osimertinib"],"companies":["jazz"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07153055","phase":"1/2","setting":"Phase I/II Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer","sponsor":"Misty Shields","started":"2026-08","startedType":"estimated","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04919226","kind":"trial","name":"Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE","aka":["COMPOSE"],"tldr":"A phase 3 trial of 177Lu-edotreotide, Temozolomide, Capecitabine, Everolimus, Leucovorin (folinic acid) and Oxaliplatin in neuroendocrine tumours, run by ITM Solucin GmbH, active and no longer recruiting.","summary":"Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE is a phase 3 interventional study registered as NCT04919226 by ITM Solucin GmbH, with 259 participants enrolled, started 2021-12-21 and due to reach its primary completion in 2027-06. Interventions recorded: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT, CAPTEM (Capecitabine and Temozolomide), Everolimus and FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04919226","url":"https://clinicaltrials.gov/study/NCT04919226"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine","grade-3-net","pancreatic-net","small-intestinal-net"],"sections":[],"technologies":["prrt","radioligand-therapy"],"targets":[],"drugs":["itm-11","temozolomide","capecitabine","everolimus","leucovorin","oxaliplatin","capecitabine-temozolomide"],"companies":["itm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04919226","phase":"3","setting":"A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin","sponsor":"ITM Solucin GmbH","started":"2021-12-21","startedType":"actual","enrolled":259,"enrolledBasis":"registry","outcomes":[]},{"id":"lux-lung-3","kind":"trial","name":"LUX-Lung 3","aka":[],"tldr":"Showed that the second-generation EGFR pill afatinib beats chemotherapy for lung cancers driven by an EGFR mutation, and that the benefit is largest for the two common mutations.","summary":"LUX-Lung 3 screened 1,269 patients and randomised 345 with EGFR-mutant stage IIIB or IV lung adenocarcinoma 2:1 to afatinib 40 mg daily or to cisplatin with pemetrexed for up to six cycles, stratified by mutation type (exon 19 deletion, L858R, or other) and race.\n\nMedian progression-free survival by independent review was 11.1 months with afatinib against 6.9 months with chemotherapy (hazard ratio 0.58, 95 percent confidence interval 0.43 to 0.78, p=0.001). Among the 308 patients with an exon 19 deletion or L858R, it was 13.6 against 6.9 months (hazard ratio 0.47, 0.34 to 0.65, p=0.001). Diarrhoea, rash or acne and stomatitis were the characteristic afatinib toxicities; patient-reported cough, breathlessness and pain were better controlled with afatinib.\n\nAfatinib is a covalent pan-ErbB inhibitor, and the later pooled analysis of LUX-Lung 2, 3 and 6 is the main evidence for treating the uncommon EGFR mutations G719X, L861Q and S768I, for which it holds a distinct FDA indication, granted in 2018, that osimertinib does not.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00949650","url":"https://clinicaltrials.gov/study/NCT00949650"},{"label":"LUX-Lung 3 (Journal of Clinical Oncology 2013)","url":"https://doi.org/10.1200/JCO.2012.44.2806"}],"tags":[],"related":[],"cancers":["egfr-mutant-nsclc","lung-adenocarcinoma"],"sections":[],"technologies":["kinase-inhibitors","cytotoxic-chemotherapy","platinum"],"targets":["egfr"],"drugs":["afatinib","cisplatin","pemetrexed"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":["egfr-exon19-l858r","egfr-mutation-subtypes","tki-term"],"trials":["flaura"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00949650","phase":"3","setting":"Untreated stage IIIB or IV lung adenocarcinoma with an EGFR mutation: afatinib 40 mg daily versus up to six cycles of cisplatin with pemetrexed, with progression-free survival by independent review as the primary endpoint","sponsor":"Boehringer Ingelheim","result":"Median progression-free survival 11.1 against 6.9 months (hazard ratio 0.58); 13.6 against 6.9 months in exon 19 deletion or L858R disease.","started":"2009-08-14","startedType":"actual","yearReported":2013,"enrolled":345,"enrolledBasis":"randomised","enrolledNote":"1,269 patients were screened for EGFR mutations and 345 mutation-positive patients were randomised; the registry figure counts the randomised population.","outcomes":[{"endpoint":"Progression-free survival (independent review)","primary":true,"unit":"months","arms":[{"name":"Afatinib","value":11.1},{"name":"Cisplatin and pemetrexed","value":6.9}],"hr":0.58,"ci":[0.43,0.78],"p":"0.001","source":"https://doi.org/10.1200/JCO.2012.44.2806"},{"endpoint":"Progression-free survival, exon 19 deletion or L858R","unit":"months","arms":[{"name":"Afatinib","value":13.6},{"name":"Cisplatin and pemetrexed","value":6.9}],"hr":0.47,"ci":[0.34,0.65],"p":"0.001","source":"https://doi.org/10.1200/JCO.2012.44.2806"}],"replication":"LUX-Lung 6 reproduced the result in an Asian population with gemcitabine and cisplatin as the comparator; FLAURA later made osimertinib the first-line standard for the common mutations."},{"id":"nct06593548","kind":"trial","name":"Lvosidenib (AK112) Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of ivosidenib in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"Lvosidenib (AK112) Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer is a phase 2, interventional study registered as NCT06593548 by Fudan University, with a registry enrolment figure of 36 participants, started 2024-11-01 and due to reach its primary completion in 2026-11-01. Interventions recorded: Ivosidenib (AK112). Conditions listed: CRC; MSS; Metastatic Cancer. Primary outcome: PFS. Colorectal eligibility wording from the registry: \"* Initial diagnosis confirmed by colonoscopy and pathology as colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06593548","url":"https://clinicaltrials.gov/study/NCT06593548"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["ivosidenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06593548","phase":"2","setting":"A Prospective, Single-arm, Single-center, Phase II Clinical Study of Ivosidenib (AK112) Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer: Efficacy and Safety Assessment","sponsor":"Fudan University","started":"2024-11-01","startedType":"estimated","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05319314","kind":"trial","name":"LYL273 for Patients With Relapsed or Refractory mCRC","aka":["CARABiNER"],"tldr":"A phase 1/2 trial of LYL273 in colorectal cancer, run by Lyell Immunopharma, Inc., now recruiting.","summary":"LYL273 for Patients With Relapsed or Refractory mCRC is a phase 1/2 interventional study registered as NCT05319314 by Lyell Immunopharma, Inc., with 155 participants planned, started 2022-08-01 and due to reach its primary completion in 2028-06. Interventions recorded: LYL273.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05319314","url":"https://clinicaltrials.gov/study/NCT05319314"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["lyell-immunopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05319314","phase":"1/2","setting":"A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of LYL273 in Patients With Relapsed or Refractory Metastatic Colorectal Cancer","sponsor":"Lyell Immunopharma, Inc.","started":"2022-08-01","startedType":"actual","enrolled":155,"enrolledBasis":"registry","outcomes":[]},{"id":"lyma","kind":"trial","name":"LyMa","aka":["Rituximab maintenance after autologous transplantation in mantle cell lymphoma","LyMa trial"],"tldr":"Three years of an antibody every two months after a stem cell transplant kept younger people with mantle cell lymphoma in remission longer and helped them live longer.","summary":"Younger patients with mantle cell lymphoma are treated intensively, with cytarabine-containing induction and an autologous stem-cell transplant, and still relapse. LyMa asked whether rituximab maintenance after the transplant changes that.\n\n299 patients under 66 at diagnosis received four courses of R-DHAP induction, after which the overall response rate was 89 per cent and the complete response rate 77 per cent. 257 were transplanted and 240 were randomised to rituximab 375 mg per square metre every two months for three years, or to observation. At a median follow-up of 50.2 months from randomisation, four-year event-free survival was 79 per cent (95 per cent confidence interval 70 to 86) with rituximab against 61 per cent (51 to 70) with observation (p = 0.001), and four-year progression-free survival 83 per cent (73 to 88) against 64 per cent (55 to 73). Overall survival was also prolonged.\n\nThis is one of the few maintenance strategies in lymphoma that improved survival rather than only progression-free survival, which is why it became standard for transplanted patients. The TRIANGLE trial has since asked whether the transplant itself is still needed when ibrutinib is added to induction and maintenance.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT00921414","url":"https://clinicaltrials.gov/study/NCT00921414"},{"label":"New England Journal of Medicine 2017","url":"https://doi.org/10.1056/NEJMoa1701769"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["mantle-cell-lymphoma","non-hodgkin-lymphoma"],"sections":["immunotherapy","cell-therapy"],"technologies":["monoclonal-antibody"],"targets":["cd20","ccnd1"],"drugs":["rituximab","dexamethasone","cytarabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":["maintenance-therapy","autologous-transplant","lymphoma-tx-maintenance","lymphoma-tx-transplant-role"],"trials":["triangle"],"people":[],"bottlenecks":["b-toxicity-qol"],"keyPapers":["paper-lyma-rituximab-maintenance-after-transplant-mantle-cell-nejm-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00921414","phase":"3","setting":"Under 66 at diagnosis with mantle cell lymphoma, after R-DHAP induction and autologous stem-cell transplantation: three years of rituximab maintenance against observation","sponsor":"French Innovative Leukemia Organisation","result":"Four-year event-free survival 79 against 61 per cent (p = 0.001) and improved overall survival with three years of rituximab maintenance after transplantation.","started":"2008-09","yearReported":2017,"enrolled":240,"enrolledBasis":"randomised","enrolledNote":"299 patients entered the trial; 257 were transplanted and 240 were randomised between maintenance and observation after transplantation.","outcomes":[{"endpoint":"Event-free survival at 4 years","primary":true,"unit":"%","arms":[{"name":"Rituximab maintenance","n":120,"value":79,"note":"95 per cent confidence interval 70 to 86"},{"name":"Observation","n":120,"value":61,"note":"51 to 70"}],"p":"0.001","source":"https://doi.org/10.1056/NEJMoa1701769"},{"endpoint":"Progression-free survival at 4 years","unit":"%","arms":[{"name":"Rituximab maintenance","n":120,"value":83,"note":"73 to 88"},{"name":"Observation","n":120,"value":64,"note":"55 to 73"}]}],"replication":"The survival benefit has not been repeated in a second randomised trial; TRIANGLE changed the induction and the transplant question rather than the maintenance question."},{"id":"nct06177041","kind":"trial","name":"M108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma","aka":[],"tldr":"A phase 3 trial testing M108 in gastric & gastro-oesophageal junction cancer, now recruiting.","summary":"M108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma is a phase 3 interventional study registered as NCT06177041, led by FutureGen Biopharmaceutical (Beijing), and recruiting on the registry. Official title: A Phase 3, Multi-Center, Double-Blind, Randomised, Efficacy and Safety Study of M108 Monoclonal Antibody Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. Planned enrolment is 486 participants (estimated). The study started in 2023-12-25 and primary completion is expected in 2027-01-11. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06177041","url":"https://clinicaltrials.gov/study/NCT06177041"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":[],"targets":[],"drugs":["m108"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06177041","phase":"3","setting":"A Phase 3, Multi-Center, Double-Blind, Randomized, Efficacy and Safety Study of M108 Monoclonal Antibody Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma","sponsor":"FutureGen Biopharmaceutical (Beijing)","started":"2023-12-25","startedType":"actual","enrolled":486,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07149649","kind":"trial","name":"Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC)","aka":[],"tldr":"A phase 2/3 trial in lung cancer, run by Swiss Cancer Institute, now recruiting.","summary":"Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC) is a phase 2/3, randomised interventional study registered as NCT07149649 by Swiss Cancer Institute, with a registry enrolment figure of 230 participants, started 2026-08 and due to reach its primary completion in 2031-01-01. Interventions recorded: Magnesiocard; Magnesium Diasporal; Microcrystalline cellulose; Isotonic saline solution 0.9%. Conditions listed: Metastatic NSCLC - Non-Small Cell Lung Cancer. Primary outcome: Primary endpoint of Phase II part: Progression-free survival (PFS); Primary endpoint of Phase III part: Overall survival (OS). Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed diagnosis of NSCLC (adeno-, squamous-, large cell carcinoma or NSCLC not otherwise specified);\". Sites: Switzerland. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07149649","url":"https://clinicaltrials.gov/study/NCT07149649"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07149649","phase":"2/3","setting":"Magnesium Supplementation in Addition to Standard Chemo-immunotherapy in Patients With Locally Advanced Unresectable Stage III or Metastatic Stage IV Non-small Cell Lung Cancer (NSCLC). A Double-blind Randomized Multicenter Phase II/III Study.","sponsor":"Swiss Cancer Institute","started":"2026-08","startedType":"estimated","enrolled":230,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02219529","kind":"trial","name":"Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases","aka":[],"tldr":"A phase 3 trial of Capsule endoscopy in Early gastric cancer, run by Changhai Hospital, completed.","summary":"Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases is a phase 3 interventional study registered as NCT02219529 by Changhai Hospital, with 350 participants recorded, started 2014-08 and reaching its primary completion in 2015-01. Interventions recorded: MCE, Standard gastroscopy. Conditions recorded: Gastric Diseases,, Gastric Ulcer,, Gastric Polyps,, Early Gastric Cancer,, Chronic Gastritis.\n\nLinked to the technology Capsule endoscopy because the registry names it (\"capsule endoscopy\") among its interventions and Early gastric cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02219529","url":"https://clinicaltrials.gov/study/NCT02219529"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["early-gastric-cancer"],"sections":[],"technologies":["capsule-endoscopy-systems"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02219529","phase":"3","setting":"Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases: A Prospective Self-controlled Comparative Multicenter Trial","sponsor":"Changhai Hospital","started":"2014-08","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"magnetismm-3","kind":"trial","name":"MagnetisMM-3","aka":[],"tldr":"MagnetisMM-3 is the pivotal study behind elranatamab's approval.","summary":"MagnetisMM-3, trial NCT04649359 sponsored by Pfizer and reported in 2023, is the pivotal single-arm study behind elranatamab's approval in relapsed or refractory myeloma after at least three prior lines in BCMA-naive patients. In 123 patients the response rate was 61 percent with complete response or better in 35 percent, progression-free survival was durable, and switching to every-two-week dosing after six months maintained responses. OnCo links it to multiple myeloma, elranatamab and the MagnetisMM-3 paper. Whether reduced dosing frequency lowers infection risk without losing efficacy is the open question its design raised.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04649359","url":"https://clinicaltrials.gov/study/NCT04649359"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["elranatamab"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04649359","phase":"2","setting":"Relapsed/refractory myeloma after ≥3 lines, BCMA-naive: elranatamab monotherapy","sponsor":"Pfizer","result":"ORR 61%.","started":"2021-02-02","startedType":"actual","yearReported":2023,"enrolled":123,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Elranatamab","n":123,"value":61}],"source":"https://doi.org/10.1038/s41591-023-02528-9"}]},{"id":"nct06152575","kind":"trial","name":"MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other","aka":["MagnetisMM-32"],"tldr":"A phase 3 trial of Elranatamab, Elotuzumab, Pomalidomide in multiple myeloma, run by Pfizer, now recruiting.","summary":"MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide) is a phase 3 interventional study registered as NCT06152575 by Pfizer, with 492 participants planned, started 2024-02-08 and due to reach its primary completion in 2026-08-30. Interventions recorded: Elranatamab, Elotuzumab, Pomalidomide, Dexamethasone, Bortezomib. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06152575","url":"https://clinicaltrials.gov/study/NCT06152575"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","kinase-inhibitors","monoclonal-antibody","protac-degrader","t-cell-engager"],"targets":[],"drugs":["elranatamab","elotuzumab","pomalidomide","dexamethasone","bortezomib","carfilzomib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06152575","phase":"3","setting":"A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY","sponsor":"Pfizer","started":"2024-02-08","startedType":"actual","enrolled":492,"enrolledBasis":"registry","outcomes":[]},{"id":"magnitude","kind":"trial","name":"MAGNITUDE","aka":[],"tldr":"PARP inhibitor plus abiraterone helped men with BRCA mutations and did nothing for those without, settling a debate.","summary":"MAGNITUDE, trial NCT03748641 sponsored by Janssen and reported in 2022, tested adding the PARP inhibitor niraparib to abiraterone in first-line metastatic castration-resistant prostate cancer in separate cohorts with and without homologous recombination repair alterations, and it settled a debate: the combination helped men with BRCA mutations and did nothing for those without. The HRR-negative cohort was stopped for futility, while the BRCA cohort met its radiographic progression-free survival endpoint and showed a survival benefit at update, and the fixed-dose combination Akeega was approved in 2023 for BRCA-mutant disease. OnCo links it to BRCA1 and BRCA2 as targets, to niraparib and abiraterone acetate. Whether the negative HRR-negative result applies to other PARP inhibitors is the open question.","status":"mixed","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT03748641","url":"https://clinicaltrials.gov/study/NCT03748641"},{"label":"NICE TA1032: niraparib with abiraterone acetate and prednisone for untreated hormone-relapsed metastatic prostate cancer, terminated appraisal","url":"https://www.nice.org.uk/guidance/terminated/ta1032"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["parp-inhibitor"],"targets":["brca"],"drugs":["niraparib","abiraterone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["prostate-hrr-eligibility","prostate-uk-drug-approvals"],"trials":["propel","talapro-2"],"people":["kim-chi"],"bottlenecks":[],"keyPapers":["paper-magnitude-j-clin-oncol-2023"],"journals":[],"dependsOn":[],"notes":["Niraparib with abiraterone acetate and prednisone has no NICE recommendation in England. NICE TA1032, terminated on 22 January 2025, states that NICE is unable to make a recommendation because Johnson and Johnson Innovative Medicine did not provide an evidence submission, and that the decision will be reviewed if the company submits. A terminated appraisal is not a refusal on the evidence; it is the absence of any evidence for NICE to appraise."],"nct":"NCT03748641","phase":"3","setting":"First-line mCRPC: abiraterone + niraparib vs abiraterone + placebo, HRR-mutant and HRR-negative cohorts","sponsor":"Janssen","result":"BRCA cohort rPFS HR 0.53; HRR-negative futility.","started":"2019-01-25","startedType":"actual","yearReported":2022,"enrolled":423,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 765 participants (actual) across all cohorts; the JCO 2023 primary analysis randomised 423 patients in the HRR-positive cohort, the population behind the headline result, and 247 in the HRR-negative cohort.","outcomes":[{"endpoint":"Radiographic progression-free survival, BRCA1/2 subgroup","primary":true,"unit":"months","arms":[{"name":"Niraparib + abiraterone","n":113,"value":16.6},{"name":"Placebo + abiraterone","n":112,"value":10.9}],"hr":0.53,"ci":[0.36,0.79],"p":"0.001","source":"https://ascopubs.org/doi/10.1200/JCO.22.01649"}],"replication":"Consistent with PROpel and TALAPRO-2 in BRCA-mutant disease; the HRR-negative cohort showed no benefit and was stopped for futility."},{"id":"nct04313881","kind":"trial","name":"Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)","aka":["ENHANCE"],"tldr":"A phase 3 trial of Magrolimab and Azacitidine in Myelodysplastic syndromes / neoplasms, run by Gilead Sciences, recorded as terminated on the registry.","summary":"Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) is a phase 3 interventional study registered as NCT04313881 by Gilead Sciences, with 539 participants recorded, started 2020-09-09 and due to reach its primary completion in 2023-09-13. Interventions recorded: Magrolimab, Azacitidine, Placebo. Conditions recorded: Myelodysplastic Syndromes.\n\nLinked to the drug Magrolimab because the registry names it among its interventions and Myelodysplastic syndromes / neoplasms among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04313881","url":"https://clinicaltrials.gov/study/NCT04313881"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mds","mds-higher-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["magrolimab","azacitidine"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04313881","phase":"3","setting":"ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome","sponsor":"Gilead Sciences","started":"2020-09-09","startedType":"actual","yearReported":2024,"enrolled":539,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Complete Remission (CR)","primary":true,"unit":"%","arms":[{"name":"Magrolimab + Azacitidine","n":268,"value":21.3,"note":"95% CI 16.5 to 26.7; Figures from the ClinicalTrials.gov results section (first posted 2024-03-21), not from a publication"},{"name":"Placebo + Azacitidine","n":271,"value":23.6,"note":"95% CI 18.7 to 29.1"}],"p":"0.5218","source":"https://clinicaltrials.gov/study/NCT04313881?tab=results"},{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Magrolimab + Azacitidine","n":268,"value":15.9,"note":"95% CI 13.3 to 19.5; Figures from the ClinicalTrials.gov results section (first posted 2024-03-21), not from a publication"},{"name":"Placebo + Azacitidine","n":271,"value":18.6,"note":"95% CI 14.9 to 26.2"}],"hr":1.203,"ci":[0.947,1.528],"p":"0.1299","source":"https://clinicaltrials.gov/study/NCT04313881?tab=results"},{"endpoint":"Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Magrolimab + Azacitidine","n":268,"value":9,"note":"95% CI 8.3 to 10.9; Figures from the ClinicalTrials.gov results section (first posted 2024-03-21), not from a publication"},{"name":"Placebo + Azacitidine","n":271,"value":9.4,"note":"95% CI 8.6 to 11.4"}],"hr":1.02,"ci":[0.802,1.297],"p":"0.8720","source":"https://clinicaltrials.gov/study/NCT04313881?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"Magrolimab + Azacitidine","n":268,"value":53.7,"note":"95% CI 47.6 to 59.8; Figures from the ClinicalTrials.gov results section (first posted 2024-03-21), not from a publication"},{"name":"Placebo + Azacitidine","n":271,"value":58.7,"note":"95% CI 52.6 to 64.6"}],"p":"0.2563","source":"https://clinicaltrials.gov/study/NCT04313881?tab=results"}]},{"id":"maia","kind":"trial","name":"MAIA","aka":[],"tldr":"MAIA showed that adding the antibody daratumumab to the standard two-drug regimen kept newly diagnosed myeloma under control for far longer in older people who cannot have a transplant, and later that they lived longer too, which made the three-drug regimen a standard first treatment.","summary":"MAIA was an open-label phase 3 trial in newly diagnosed multiple myeloma in patients ineligible for high-dose therapy and autologous transplant because of age or comorbidity. Patients were randomised to daratumumab plus lenalidomide and dexamethasone or to lenalidomide and dexamethasone, in both arms until progression.\n\nThe daratumumab arm had significantly longer progression-free survival, the primary endpoint, with deeper responses and more patients reaching measurable residual disease negativity. The regimen was approved in the United States in June 2019 for this setting, and a later analysis showed an overall survival benefit as well. MAIA and ALCYONE established daratumumab in first-line myeloma; CEPHEUS and IMROZ have since added it or isatuximab to bortezomib-containing triplets.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02252172","url":"https://clinicaltrials.gov/study/NCT02252172"}],"tags":["subtype-trials"],"related":[],"cancers":["myeloma-transplant-ineligible","multiple-myeloma"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["daratumumab","lenalidomide","dexamethasone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["thierry-facon"],"bottlenecks":[],"keyPapers":["paper-maia-daratumumab-rd-nejm-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02252172","phase":"3","setting":"Newly diagnosed multiple myeloma in patients not eligible for autologous transplant: daratumumab with lenalidomide and dexamethasone against lenalidomide and dexamethasone, both continued until progression","sponsor":"Janssen","result":"Daratumumab, lenalidomide and dexamethasone improved progression-free and later overall survival over lenalidomide and dexamethasone in transplant-ineligible newly diagnosed myeloma; approved in June 2019.","started":"2015-02-16","startedType":"actual","yearReported":2019,"enrolled":737,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 30 months","primary":true,"unit":"%","arms":[{"name":"Daratumumab + lenalidomide + dexamethasone","n":368,"value":70.6,"note":"Median follow-up 28.0 months"},{"name":"Lenalidomide + dexamethasone","n":369,"value":55.6}],"hr":0.56,"ci":[0.43,0.73],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1817249"},{"endpoint":"Complete response or better","unit":"%","arms":[{"name":"Daratumumab + lenalidomide + dexamethasone","n":368,"value":47.6},{"name":"Lenalidomide + dexamethasone","n":369,"value":24.9}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1817249"},{"endpoint":"Minimal residual disease negativity (10^-5)","unit":"%","arms":[{"name":"Daratumumab + lenalidomide + dexamethasone","n":368,"value":24.2},{"name":"Lenalidomide + dexamethasone","n":369,"value":7.3}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1817249"}]},{"id":"nct07199764","kind":"trial","name":"Maintenance Combinatorial Myeloid Immunotherapy for Unresectable Pancreatic Cancer","aka":["IGNITE"],"tldr":"A phase 2 trial of mitazalimab in pancreatic cancer, run by University of Pennsylvania, now recruiting.","summary":"Maintenance Combinatorial Myeloid Immunotherapy for Unresectable Pancreatic Cancer is a phase 2, interventional study registered as NCT07199764 by University of Pennsylvania, with a registry enrolment figure of 100 participants, started 2025-11-25 and due to reach its primary completion in 2027-10. Interventions recorded: Odetiglucan; Mitazalimab. Conditions listed: Pancreatic Ductal Adenocarcinoma. Primary outcome: Median progression-free survival (mPFS) of 7.5 months in Cohort A. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma that is either locally advanced and unresectable, or metastatic\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07199764","url":"https://clinicaltrials.gov/study/NCT07199764"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["mitazalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07199764","phase":"2","setting":"IGNITE: A Phase 2 Study of Maintenance Combinatorial Myeloid Immunotherapy in Patients With Unresectable Pancreatic Ductal Adenocarcinoma","sponsor":"University of Pennsylvania","started":"2025-11-25","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06419179","kind":"trial","name":"Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in HRD Positive Extens","aka":["GUIDANCE"],"tldr":"A phase 2 trial of durvalumab and olaparib in lung cancer, run by University of Cologne, now recruiting.","summary":"Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in HRD Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC) is a phase 2, interventional study registered as NCT06419179 by University of Cologne, with a registry enrolment figure of 29 participants, started 2024-10-09 and due to reach its primary completion in 2026-09. Interventions recorded: Durvalumab; Olaparib. Conditions listed: Small Cell Lung Carcinoma. Primary outcome: Progression-free survival (PFS). Lung eligibility wording from the registry: \"* Newly diagnosed, histologically documented advanced or metastatic small-cell lung cancer (UICC stage III which is not amenable to curative radiochemotherapy or stage IV)\". Sites: Germany. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06419179","url":"https://clinicaltrials.gov/study/NCT06419179"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["durvalumab","olaparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06419179","phase":"2","setting":"A Multicenter Phase II Trial of Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in Homologous Recombination Deficiency (HRD) Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC)","sponsor":"University of Cologne","started":"2024-10-09","startedType":"actual","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06747845","kind":"trial","name":"Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy","aka":["ParpVax2"],"tldr":"A phase 2 trial of niraparib and ipilimumab in pancreatic cancer, run by Abramson Cancer Center at Penn Medicine, now recruiting.","summary":"Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy is a phase 2, randomised interventional study registered as NCT06747845 by Abramson Cancer Center at Penn Medicine, with a registry enrolment figure of 68 participants, started 2025-05-07 and due to reach its primary completion in 2028-06. Interventions recorded: Niraparib; FOLFIRI; Ipilimumab. Conditions listed: Pancreatic Adenocarcinoma Metastatic. Primary outcome: Progression-free survival (PFS) in the experimental arm. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06747845","url":"https://clinicaltrials.gov/study/NCT06747845"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["niraparib","ipilimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06747845","phase":"2","setting":"ParpVax2: A Phase II Study Of Maintenance Niraparib Plus Ipilimumab In Patients With Metastatic Pancreatic Cancer Whose Disease Has Not Progressed On Platinum-Based Therapy","sponsor":"Abramson Cancer Center at Penn Medicine","started":"2025-05-07","startedType":"actual","enrolled":68,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05692999","kind":"trial","name":"Maintenance Pembrolizumab at Usual or Low doSE in Non-squamous Lung Cancer: a Non-inferiority Study","aka":["Pulse"],"tldr":"A phase 3 trial in lung cancer, run by Gustave Roussy, Cancer Campus, Grand Paris, now recruiting.","summary":"Maintenance Pembrolizumab at Usual or Low doSE in Non-squamous Lung Cancer: a Non-inferiority Study is a phase 3, randomised interventional study registered as NCT05692999 by Gustave Roussy, Cancer Campus, Grand Paris, with a registry enrolment figure of 1166 participants, started 2023-03-20 and due to reach its primary completion in 2029-01. Interventions recorded: Pembrolizumab 200 mg Q6W; Pemetrexed 500 mg/m^2 Q3W; Pembrolizumab 200 mg Q3W or 400 mg Q6W. Conditions listed: Metastatic Non-squamous Lung Cancer. Primary outcome: Overall survival. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC)\". Sites: Belgium, France, Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05692999","url":"https://clinicaltrials.gov/study/NCT05692999"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05692999","phase":"3","setting":"Maintenance Pembrolizumab at Usual or Low doSE in Non-squamous Lung Cancer: a Non-inferiority Study","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","started":"2023-03-20","startedType":"actual","enrolled":1166,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05360277","kind":"trial","name":"Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer","aka":["CAMCO2"],"tldr":"A phase 2 trial of tislelizumab and capecitabine in colorectal cancer, run by Yanhong Deng, now recruiting.","summary":"Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT05360277 by Yanhong Deng, with a registry enrolment figure of 52 participants, started 2023-08-22 and due to reach its primary completion in 2025-02-28. Interventions recorded: Tislelizumab + Capecitabine; Best supportive care. Conditions listed: Metastatic Colorectal Cancer，NED. Primary outcome: Disease-free survival. Colorectal eligibility wording from the registry: \"Surgery with integrated treatment for metastatic colorectal cancer (mCRC) and achieved a statute of no evidence of disease (NED), as determined by a multidisciplinary tumor board\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05360277","url":"https://clinicaltrials.gov/study/NCT05360277"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["tislelizumab","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05360277","phase":"2","setting":"Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease","sponsor":"Yanhong Deng","started":"2023-08-22","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03519230","kind":"trial","name":"Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer","aka":[],"tldr":"A phase 3 trial of Pamiparib capsule in ovarian cancer, run by BeiGene, active and no longer recruiting.","summary":"Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer is a phase 3 interventional study registered as NCT03519230 by BeiGene, with 224 participants enrolled, started 2018-05-14 and due to reach its primary completion in 2025-12-01. Interventions recorded: Pamiparib capsule and Placebo capsule.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03519230","url":"https://clinicaltrials.gov/study/NCT03519230"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pamiparib"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03519230","phase":"3","setting":"A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With BGB-290 Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer","sponsor":"BeiGene","started":"2018-05-14","startedType":"actual","enrolled":224,"enrolledBasis":"registry","outcomes":[]},{"id":"majestec-1","kind":"trial","name":"MajesTEC-1","aka":[],"tldr":"MajesTEC-1 was the pivotal single-arm study for the first myeloma bispecific, with responses in 63% of patients who had exhausted the main drug classes.","summary":"MajesTEC-1, trial NCT04557098 sponsored by Janssen and published in the New England Journal of Medicine in 2022, was the pivotal single-arm study for teclistamab, the first bispecific antibody approved in myeloma, with responses in 63 percent of patients who had exhausted the main drug classes. In 165 patients after at least three prior lines the response rate was 63 percent with complete response or better in 39 percent, responses were durable at 30 months of follow-up, and infections were the leading cause of non-relapse death, prompting immunoglobulin prophylaxis. OnCo links it to multiple myeloma, teclistamab, Philippe Moreau, Saad Z. Usmani and the MajesTEC-1 paper. Whether infection risk can be managed well enough for use outside specialist centres is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04557098","url":"https://clinicaltrials.gov/study/NCT04557098"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["teclistamab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["philippe-moreau","saad-usmani"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04557098","phase":"1/2","setting":"Relapsed/refractory myeloma after ≥3 lines: teclistamab monotherapy","sponsor":"Janssen","result":"ORR 63%, ≥CR 39%.","started":"2020-09-17","startedType":"actual","yearReported":2022,"enrolled":165,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Teclistamab","n":165,"value":63}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2203478"}]},{"id":"majestec-3","kind":"trial","name":"MajesTEC-3","aka":[],"tldr":"A bispecific plus daratumumab cut the risk of progression by more than 80% versus standard doublets, bringing bispecifics to second line.","summary":"MajesTEC-3, trial NCT05083169 sponsored by Janssen and reported in 2025, showed that the BCMA bispecific teclistamab plus daratumumab cut the risk of progression by more than eighty percent versus daratumumab-based doublets in relapsed or refractory myeloma after one to three prior lines, bringing bispecifics into the second line. It randomised 587 patients and met its primary progression-free survival endpoint with the median not reached against about eighteen months, leading to FDA approval on 5 March 2026 for patients with at least one prior line, with EU approval following and infection prophylaxis mandatory. OnCo links it to multiple myeloma, teclistamab, daratumumab, Philippe Moreau and the MajesTEC-1 paper. How bispecifics and CAR-T should be sequenced against each other in early relapse is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05083169","url":"https://clinicaltrials.gov/study/NCT05083169"},{"label":"FDA approval (J&J)","url":"https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-u-s-fda-approval-of-tecvayli-plus-darzalex-faspro-for-relapsed-refractory-multiple-myeloma-offering-a-potential-new-standard-of-care-as-early-as-second-line"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["teclistamab","daratumumab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["philippe-moreau"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05083169","phase":"3","setting":"Relapsed/refractory myeloma after 1-3 prior lines: teclistamab + daratumumab vs Dara-Pd or Dara-Vd","sponsor":"Janssen","result":"36-month PFS 83.4% vs 29.7%; HR ~0.17.","started":"2021-10-14","startedType":"actual","yearReported":2025,"enrolled":587,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 36 months","primary":true,"unit":"%","arms":[{"name":"Teclistamab + daratumumab","value":83.4},{"name":"Dara-Pd / Dara-Vd","value":29.7}],"hr":0.17,"source":"https://oncodaily.com/techology/majestec-3468305"}]},{"id":"majic-et","kind":"trial","name":"MAJIC-ET","aka":[],"tldr":"MAJIC-ET found that ruxolitinib was no better than the usual second-line drugs at controlling platelets in ET, although it eased itching and other symptoms.","summary":"MAJIC-ET randomised 110 patients with essential thrombocythaemia resistant to or intolerant of hydroxyurea to ruxolitinib or best available therapy (mostly anagrelide or interferon). Complete response at one year, the primary endpoint, did not differ (about 47 percent in each arm), nor did thrombosis, haemorrhage or transformation; ruxolitinib improved some symptom scores (Harrison and colleagues, Blood 2017). Registered as ISRCTN61925716 alongside MAJIC-PV.","status":"negative","asOf":"2026-09-16","links":[{"label":"ISRCTN61925716","url":"https://www.isrctn.com/ISRCTN61925716"}],"tags":["essential-thrombocythaemia","mpn"],"related":[],"cancers":["essential-thrombocythaemia"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ruxolitinib","anagrelide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"2","setting":"Hydroxyurea-resistant or intolerant essential thrombocythaemia: ruxolitinib versus best available therapy","sponsor":"University of Birmingham (UK)","result":"Complete response within 1 year 46.6% (ruxolitinib) vs 44.2% (best available therapy), not significant; no difference in clots, bleeding or transformation at 2 years.","yearReported":2017,"enrolled":110,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response within 1 year","primary":true,"unit":"%","arms":[{"name":"Ruxolitinib","n":58,"value":46.6},{"name":"Best available therapy","n":52,"value":44.2}],"p":"0.40","source":"https://doi.org/10.1182/blood-2017-05-785790"}]},{"id":"majic-pv","kind":"trial","name":"MAJIC-PV","aka":[],"tldr":"MAJIC-PV, a UK academic trial, found that ruxolitinib gave more complete responses than best available therapy and, for the first time, that a complete response went with fewer clots and progressions.","summary":"MAJIC-PV randomised 180 patients with PV resistant to or intolerant of hydroxyurea to ruxolitinib or best available therapy. Complete response within a year, the primary endpoint, was reached by 43 percent on ruxolitinib versus 26 percent on best available therapy; complete responders had better event-free survival (thrombosis, haemorrhage, transformation or death), and the JAK2 V617F allele burden fell more on ruxolitinib (Harrison and colleagues, Journal of Clinical Oncology 2023). Registered as ISRCTN61925716.","status":"positive","asOf":"2026-09-16","links":[{"label":"ISRCTN61925716","url":"https://www.isrctn.com/ISRCTN61925716"},{"label":"JCO 2023","url":"https://doi.org/10.1200/JCO.22.01935"}],"tags":["polycythaemia-vera","mpn"],"related":[],"cancers":["polycythaemia-vera"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ruxolitinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-harrison-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"phase":"2","setting":"Hydroxyurea-resistant or intolerant polycythaemia vera: ruxolitinib versus best available therapy","sponsor":"University of Birmingham (UK)","result":"Complete response within 1 year: 43% vs 26%; complete response associated with better event-free survival.","yearReported":2023,"enrolled":180,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response within 1 year","primary":true,"unit":"%","arms":[{"name":"Ruxolitinib","n":93,"value":43},{"name":"Best available therapy","n":87,"value":26}]}]},{"id":"manifest-2","kind":"trial","name":"MANIFEST-2","aka":[],"tldr":"MANIFEST-2 found that adding the BET inhibitor pelabresib to ruxolitinib shrank spleens in nearly twice as many people with myelofibrosis, but the improvement in symptoms did not reach statistical significance, leaving the drug's approval uncertain.","summary":"BET proteins read the epigenetic marks that drive the inflammatory and fibrotic programme of myelofibrosis. MANIFEST-2 randomised 430 patients with myelofibrosis who had not yet received a JAK inhibitor to ruxolitinib with pelabresib or with placebo. The primary endpoint was a spleen volume reduction of 35 percent or more at week 24; the key secondary endpoint was a 50 percent or greater fall in total symptom score.\n\nThe combination roughly doubled the spleen response rate, meeting the primary endpoint, and showed improvements in bone marrow fibrosis and anaemia, but the symptom endpoint favoured the combination without reaching statistical significance. Regulators asked for more data, and the drug had not been approved by the time of writing.","status":"mixed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04603495","url":"https://clinicaltrials.gov/study/NCT04603495"}],"tags":["subtype-trials"],"related":[],"cancers":["primary-myelofibrosis","myeloproliferative-neoplasms"],"sections":[],"technologies":[],"targets":[],"drugs":["pelabresib","ruxolitinib"],"companies":["novartis","morphosys"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["raajit-rampal"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04603495","phase":"3","setting":"JAK inhibitor-naive myelofibrosis: ruxolitinib with the BET inhibitor pelabresib or placebo","sponsor":"Novartis (Constellation, MorphoSys)","result":"Pelabresib plus ruxolitinib roughly doubled the week-24 spleen volume response over ruxolitinib alone; the symptom endpoint did not reach significance.","started":"2021-04-09","startedType":"actual","yearReported":2024,"enrolled":430,"enrolledBasis":"registry","outcomes":[{"endpoint":"Spleen volume reduction >=35% at week 24","primary":true,"unit":"%","arms":[{"name":"Pelabresib + ruxolitinib","n":214,"value":65.9,"note":"Difference 30.4% (95% CI 21.6 to 39.3)"},{"name":"Placebo + ruxolitinib","n":216,"value":35.2}],"p":"<0.001","source":"https://doi.org/10.1038/s41591-025-03572-3"},{"endpoint":"Total symptom score reduction >=50% at week 24 (TSS50)","unit":"%","arms":[{"name":"Pelabresib + ruxolitinib","n":214,"value":52.3,"note":"Difference 6.0% (95% CI -3.5 to 15.5)"},{"name":"Placebo + ruxolitinib","n":216,"value":46.3}],"source":"https://doi.org/10.1038/s41591-025-03572-3"},{"endpoint":"Absolute change in total symptom score at week 24","unit":"points","arms":[{"name":"Pelabresib + ruxolitinib","n":214,"value":-15.99,"note":"Difference -1.94 (95% CI -3.92 to 0.04)"},{"name":"Placebo + ruxolitinib","n":216,"value":-14.05}],"p":"0.0545","source":"https://doi.org/10.1038/s41591-025-03572-3"},{"endpoint":"Grade 3 or higher anaemia","unit":"%","arms":[{"name":"Pelabresib + ruxolitinib","n":214,"value":23.1},{"name":"Placebo + ruxolitinib","n":216,"value":36.5}],"source":"https://doi.org/10.1038/s41591-025-03572-3"},{"endpoint":"Grade 3 or higher thrombocytopenia","unit":"%","arms":[{"name":"Pelabresib + ruxolitinib","n":214,"value":13.2},{"name":"Placebo + ruxolitinib","n":216,"value":6.1}],"source":"https://doi.org/10.1038/s41591-025-03572-3"}]},{"id":"nct06349590","kind":"trial","name":"Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery","aka":["DIET"],"tldr":"A phase 1/2 trial in colorectal cancer, run by University of Chicago, now recruiting.","summary":"Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery is a phase 1/2, interventional study registered as NCT06349590 by University of Chicago, with a registry enrolment figure of 80 participants, started 2024-06-27 and due to reach its primary completion in 2026-04-06. Interventions recorded: High-fiber/low-fat meals. Conditions listed: Colorectal Cancer. Primary outcome: Change in lab values of the dietary intervention on the collagenolytic potential of the microenvironment.. Colorectal eligibility wording from the registry: \"* Must have histologically or cytologically confirmed colorectal adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06349590","url":"https://clinicaltrials.gov/study/NCT06349590"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06349590","phase":"1/2","setting":"A Phase 1/2 Study of Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery (The DIET Trial)","sponsor":"University of Chicago","started":"2024-06-27","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"maps","kind":"trial","name":"MAPS","aka":[],"tldr":"In MAPS, adding the anti-VEGF antibody bevacizumab to chemotherapy lengthened survival by about three months, the first improvement after pemetrexed.","summary":"MAPS, trial NCT00651456 sponsored by the French IFCT group and reported in 2016, showed that adding the anti-VEGF antibody bevacizumab to first-line cisplatin and pemetrexed in unresectable pleural mesothelioma lengthened survival by about three months, the first improvement after pemetrexed itself. It randomised 448 patients and met its primary overall survival endpoint, establishing angiogenesis as a valid target in the disease. OnCo links it to mesothelioma, anti-angiogenic therapy, VEGF as a target and pemetrexed. Bevacizumab is listed by NCCN for mesothelioma but never received an FDA indication, so use varies, and because no second phase 3 replicated it while nintedanib failed in LUME-Meso, whether the anti-angiogenic benefit is real or specific to bevacizumab is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00651456","url":"https://clinicaltrials.gov/study/NCT00651456"}],"tags":[],"related":[],"cancers":["mesothelioma"],"sections":[],"technologies":["antiangiogenic"],"targets":["vegf"],"drugs":["pemetrexed"],"companies":["ifct"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00651456","phase":"2/3","setting":"Unresectable pleural mesothelioma, first line: cisplatin-pemetrexed ± bevacizumab","sponsor":"IFCT (France)","result":"OS 18.8 vs 16.1 months, HR 0.77.","started":"2008-02","yearReported":2016,"enrolled":448,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Chemotherapy + bevacizumab","n":223,"value":18.8},{"name":"Chemotherapy","n":225,"value":16.1}],"hr":0.77,"ci":[0.62,0.95],"p":"0.0167","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01238-6/fulltext"}],"replication":"Not replicated by a second phase 3; nintedanib (LUME-Meso) failed to reproduce the anti-angiogenic benefit."},{"id":"nct04425018","kind":"trial","name":"MARGetuximab Or Trastuzumab (MARGOT)","aka":["MARGOT"],"tldr":"A phase 2 trial of Paclitaxel / nab-paclitaxel, Pertuzumab, Margetuximab, Trastuzumab and Trastuzumab biosimilars in Breast cancer and HER2-positive breast cancer, run by Dana-Farber Cancer Institute, active and no longer recruiting.","summary":"MARGetuximab Or Trastuzumab (MARGOT) is a phase 2 interventional study registered as NCT04425018 by Dana-Farber Cancer Institute, with 174 participants planned, started 2020-07-13 and due to reach its primary completion in 2024-10-24. Interventions recorded: Paclitaxel, Pertuzumab, Margetuximab, Trastuzumab. Conditions recorded: Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, HER2-positive Breast Cancer.\n\nLinked to the drug Margetuximab because the registry names it among its interventions and Breast cancer and HER2-positive breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04425018","url":"https://clinicaltrials.gov/study/NCT04425018"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer","breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["paclitaxel","pertuzumab","margetuximab","trastuzumab","trastuzumab-biosimilars"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04425018","phase":"2","setting":"MARGetuximab Or Trastuzumab (MARGOT): A Phase II Study Comparing Neoadjuvant Paclitaxel/Margetuximab/Pertuzumab to Paclitaxel/Trastuzumab/Pertuzumab in Patients With Stage II-III HER2-positive Breast Cancer","sponsor":"Dana-Farber Cancer Institute","started":"2020-07-13","startedType":"actual","enrolled":174,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02492711","kind":"trial","name":"Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial of Margetuximab and Trastuzumab in Breast cancer, run by MacroGenics, completed.","summary":"Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer is a phase 3 interventional study registered as NCT02492711 by MacroGenics, with 624 participants recorded, started 2015-08-24 and reaching its primary completion in 2021-08-11. Interventions recorded: Margetuximab, Trastuzumab, Physician's choice of chemotherapy.. Conditions recorded: HER-2 Positive Breast Cancer, Metastatic Neoplasm.\n\nLinked to the drug Margetuximab because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02492711","url":"https://clinicaltrials.gov/study/NCT02492711"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["margetuximab","trastuzumab"],"companies":["macrogenics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02492711","phase":"3","setting":"A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment","sponsor":"MacroGenics","started":"2015-08-24","startedType":"actual","yearReported":2022,"enrolled":624,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (PFS) as Determined by Independent Radiological Review.","primary":true,"unit":"months","arms":[{"name":"Margetuximab Plus Chemotherapy","n":266,"value":5.8,"note":"95% CI 5.52 to 6.97; Figures from the ClinicalTrials.gov results section (first posted 2022-11-23), not from a publication"},{"name":"Trastuzumab Plus Chemotherapy","n":270,"value":4.9,"note":"95% CI 4.17 to 5.59"}],"hr":0.76,"ci":[0.593,0.979],"p":"0.0334","source":"https://clinicaltrials.gov/study/NCT02492711?tab=results"},{"endpoint":"Overall Survival (OS) Defined as the Number of Days From Randomization to the Date of Death (From Any Cause).","primary":true,"unit":"months","arms":[{"name":"Margetuximab Plus Chemotherapy","n":266,"value":21.6,"note":"95% CI 0.66 to 61.44; Figures from the ClinicalTrials.gov results section (first posted 2022-11-23), not from a publication"},{"name":"Trastuzumab Plus Chemotherapy","n":270,"value":21.9,"note":"95% CI 0.07 to 64.53"}],"hr":0.95,"ci":[0.774,1.165],"p":"0.6204","source":"https://clinicaltrials.gov/study/NCT02492711?tab=results"}]},{"id":"mariposa","kind":"trial","name":"MARIPOSA","aka":[],"tldr":"The first regimen to beat osimertinib in EGFR-mutant lung cancer, with a survival benefit exceeding a year.","summary":"MARIPOSA, trial NCT04487080 sponsored by Johnson & Johnson and published in the New England Journal of Medicine in 2024, produced the first regimen to beat osimertinib in first-line EGFR-mutant non-small-cell lung cancer, with a survival benefit exceeding a year. It randomised 1,074 patients to amivantamab plus lazertinib or osimertinib, met its primary progression-free survival endpoint by blinded review and showed an overall survival benefit in 2025, at the cost of venous thromboembolism needing prophylaxis and skin toxicity needing management. Whether the survival gain justifies the added toxicity for every patient is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT04487080","url":"https://clinicaltrials.gov/study/NCT04487080"}],"tags":[],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["bispecific-antibody"],"targets":["egfr","met"],"drugs":["amivantamab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["lee-dae-ho","cho-byoung-chul"],"bottlenecks":[],"keyPapers":["paper-flaura-nejm-2018","paper-mariposa-nejm-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04487080","phase":"3","setting":"First-line EGFR-mutant NSCLC: amivantamab + lazertinib vs osimertinib","sponsor":"Johnson & Johnson","result":"PFS HR 0.70; OS HR 0.75.","started":"2020-09-30","startedType":"actual","yearReported":2023,"enrolled":1074,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Amivantamab + lazertinib","n":429,"value":23.7},{"name":"Osimertinib","n":429,"value":16.6}],"hr":0.7,"ci":[0.58,0.85],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2403614"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Amivantamab + lazertinib","note":"Median not reached"},{"name":"Osimertinib","value":36.7}],"hr":0.75,"ci":[0.61,0.92],"p":"0.005","source":"https://clinicaltrials.gov/study/NCT04487080"}],"replication":"Single pivotal trial versus osimertinib; MARIPOSA-2 (post-osimertinib) and PALOMA-3 (subcutaneous) support the regimen in adjacent settings."},{"id":"mars-2","kind":"trial","name":"MARS 2","aka":[],"tldr":"MARS 2 is the trial that overturned decades of surgical practice: removing the lining of the lung did not help patients live longer and left them worse off.","summary":"Survival was worse with surgery (HR 1.28, 95% CI 1.02-1.60; median 19.3 vs 24.8 months), with more serious adverse events and poorer quality of life. Extended pleurectomy/decortication is no longer recommended outside trials in most guidelines; MARS 1 had earlier cast doubt on extrapleural pneumonectomy.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02040272","url":"https://clinicaltrials.gov/study/NCT02040272"}],"tags":["lesson:surgery-without-evidence"],"related":[],"cancers":["mesothelioma","pleural-mesothelioma"],"sections":[],"technologies":["pleurectomy-decortication"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["dean-fennell"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02040272","phase":"3","setting":"Resectable pleural mesothelioma: extended pleurectomy/decortication + chemotherapy vs chemotherapy alone","sponsor":"Royal Brompton / NIHR (UK)","result":"OS HR 1.28 favouring no surgery; median 19.3 vs 24.8 months.","started":"2015-05","yearReported":2024,"enrolled":335,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Surgery + chemotherapy","n":169,"value":19.3},{"name":"Chemotherapy alone","n":166,"value":24.8}],"hr":1.28,"ci":[1.02,1.6],"source":"https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(24)00119-X/fulltext"}],"replication":"Consistent with MARS 1 feasibility results; no trial has shown a survival benefit for radical mesothelioma surgery."},{"id":"masai","kind":"trial","name":"MASAI (Mammography Screening with Artificial Intelligence)","aka":[],"tldr":"The first randomised trial of AI in breast screening found more cancers and cut radiologists' reading work almost in half without more false alarms.","summary":"The prespecified interim safety analysis (Lancet Oncology 2023) of 80,020 women reported a cancer detection rate of 6.1 per 1,000 in the AI-supported arm versus 5.1 per 1,000 with standard double reading, similar recall rates (2.2% versus 2.0%) and false-positive rates (1.5% in both), and a 44.3% reduction in screen-reading workload. The final analysis of the full cohort (published 2025) confirmed a 29% increase in cancer detection, driven by small invasive cancers and in situ disease, with the interval-cancer endpoint to follow. MASAI is the evidence base for the AI-as-one-reader model that several European programmes, and the NHS EDITH trial, are now adopting.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT04838756","url":"https://clinicaltrials.gov/study/NCT04838756"},{"label":"MASAI interim analysis (Lancet Oncol 2023)","url":"https://doi.org/10.1016/S1470-2045(23)00298-X"}],"tags":[],"related":[],"cancers":["breast-hr-positive","tnbc"],"sections":[],"technologies":["mammography","radiology-ai-screening"],"targets":[],"drugs":["transpara"],"companies":["screenpoint-medical"],"institutions":[],"pathways":[],"terms":["screening"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-masai-lancet-digit-health-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04838756","phase":"3","setting":"Population screening in Sweden: AI-supported reading (Transpara, single or double reading by risk score) versus standard double reading","sponsor":"Lund University / Region Skåne","result":"Cancer detection 6.1 vs 5.1 per 1,000; screen-reading workload reduced 44.3% (interim).","started":"2021-04-12","startedType":"actual","yearReported":2023,"enrolled":105934,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 100,000 participants (actual); the Lancet 2026 interval-cancer analysis reports 105,934 women randomly assigned between April 2021 and December 2022.","outcomes":[{"endpoint":"Cancer detection rate (interim analysis)","unit":"per 1,000 screened","arms":[{"name":"AI-supported screening","n":39996,"value":6.1},{"name":"Standard double reading","n":40024,"value":5.1}],"source":"https://doi.org/10.1016/S1470-2045(23)00298-X"}]},{"id":"nct06277154","kind":"trial","name":"MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma","aka":[],"tldr":"A phase 2 trial of Doxorubicin, Ifosfamide in vascular tumours and epithelioid sarcoma, run by HRYZ Biotech Co., now recruiting.","summary":"MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma is a phase 2 interventional study registered as NCT06277154 by HRYZ Biotech Co., with 148 participants planned, started 2024-02-21 and due to reach its primary completion in 2026-02. Interventions recorded: MASCT-I, Doxorubicin, Ifosfamide. Conditions listed: Leiomyosarcoma, Liposarcoma, Synovial Sarcoma, Angiosarcoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06277154","url":"https://clinicaltrials.gov/study/NCT06277154"}],"tags":["ctgov-ingest"],"related":[],"cancers":["vascular-tumours","epithelioid-sarcoma","rhabdomyosarcoma","uterine-sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["doxorubicin","ifosfamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06277154","phase":"2","setting":"A Phase II Study Evaluating the Safety and Efficacy of MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment in Patients With Advanced Soft Tissue Sarcoma","sponsor":"HRYZ Biotech Co.","started":"2024-02-21","startedType":"actual","enrolled":148,"enrolledBasis":"registry","outcomes":[]},{"id":"mroc","kind":"trial","name":"Mastectomy Reconstruction Outcomes Consortium (MROC)","aka":["MROC study"],"tldr":"The study that lets a woman compare the two kinds of reconstruction honestly. Building a breast from her own tissue gives her a result she is happier with two years later; it also roughly doubles the chance of a complication and of needing another operation to fix one.","summary":"MROC recruited 2,343 women having first-time reconstruction after mastectomy from eleven North American centres and 57 plastic surgeons between February 2012 and July 2015, and followed them for two years with both complication data and the BREAST-Q, a validated patient-reported outcome instrument. 1,525 (65.1 percent) had expander-implant reconstruction, 112 (4.8 percent) direct-to-implant, 390 (16.6 percent) deep inferior epigastric perforator flaps, and the rest other flaps.\n\nOn satisfaction, 1,217 women (60.5 percent) answered at two years. After adjustment for baseline characteristics, autologous reconstruction beat implant reconstruction on satisfaction with breasts (difference 7.94 points, 95 percent confidence interval 5.68 to 10.20, p<0.001), psychosocial wellbeing (3.27, 1.25 to 5.29, p=0.002) and sexual wellbeing (5.53, 2.95 to 8.11, p<0.001).\n\nOn complications the direction reverses. Complications occurred in 771 women (32.9 percent), reoperative complications in 453 (19.3 percent) and wound infections in 230 (9.8 percent). Against expander-implant reconstruction, every autologous technique carried higher odds of any complication: deep inferior epigastric perforator flap 1.97 (1.41 to 2.76, p<0.001), free transverse rectus abdominis myocutaneous flap 2.05 (1.24 to 3.40), the pedicled version 1.91 (1.10 to 3.31), latissimus dorsi 1.87 (1.03 to 3.40) and superficial inferior epigastric artery flap 4.71 (2.32 to 9.54). All the flap procedures except latissimus dorsi also carried higher odds of a reoperative complication.\n\nOne number runs the other way and matters for a woman choosing. Failure of the reconstruction was commonest with implants: 7.1 percent for the expander-implant and direct-to-implant techniques, against 1.3 percent for deep inferior epigastric perforator flaps, 2.1 percent for free transverse rectus abdominis myocutaneous flaps and none for superficial inferior epigastric artery flaps (p<0.001). The trade is a higher chance of something going wrong against a lower chance of the whole reconstruction being lost.","status":"completed","asOf":"2026-09-25","links":[{"label":"MROC long-term patient-reported outcomes (JAMA Surgery 2018)","url":"https://doi.org/10.1001/jamasurg.2018.1677"},{"label":"MROC two-year complication rates (JAMA Surgery 2018)","url":"https://doi.org/10.1001/jamasurg.2018.1687"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["breast-reconstruction","mastectomy","body-image-after-breast-surgery"],"trials":["ibra-study","pre-bra"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"observational","setting":"First-time breast reconstruction after mastectomy at eleven centres: implant techniques (direct-to-implant, expander-implant) against autologous techniques (latissimus dorsi, pedicled and free transverse rectus abdominis myocutaneous, deep inferior epigastric perforator and superficial inferior epigastric artery flaps), with two-year complications and BREAST-Q patient-reported outcomes","sponsor":"University of Michigan, across eleven North American centres","result":"At two years, autologous reconstruction gave higher satisfaction with breasts (7.94 points on the BREAST-Q), psychosocial and sexual wellbeing than implants, but roughly double the odds of a complication; reconstruction failed in 7.1 percent of implant cases against 1.3 percent of deep inferior epigastric perforator flaps.","yearReported":2018,"enrolled":2343,"enrolledBasis":"registry","outcomes":[{"endpoint":"Satisfaction with breasts at 2 years, adjusted difference on the BREAST-Q","primary":true,"unit":"points","arms":[{"name":"Autologous reconstruction against implant reconstruction","value":7.94,"note":"95 percent confidence interval 5.68 to 10.20, p<0.001"}],"source":"https://doi.org/10.1001/jamasurg.2018.1677"},{"endpoint":"Any complication within 2 years, deep inferior epigastric perforator flap against expander-implant","unit":"odds ratio","arms":[{"name":"Deep inferior epigastric perforator flap","n":390,"value":1.97,"note":"95 percent confidence interval 1.41 to 2.76, p<0.001"}],"source":"https://doi.org/10.1001/jamasurg.2018.1687"},{"endpoint":"Reconstruction failure within 2 years","unit":"%","arms":[{"name":"Expander-implant and direct-to-implant","value":7.1},{"name":"Deep inferior epigastric perforator flap","n":390,"value":1.3},{"name":"Free transverse rectus abdominis myocutaneous flap","n":95,"value":2.1}],"p":"<0.001","source":"https://doi.org/10.1001/jamasurg.2018.1687"}]},{"id":"ielsg43","kind":"trial","name":"MATRix/IELSG43","aka":["IELSG43","IELSG-43","MATRix"],"tldr":"MATRix/IELSG43 settled how to consolidate remission in lymphoma of the brain: after MATRix chemotherapy, a high-dose chemotherapy and stem cell transplant kept 78 percent of patients free of progression at three years against 51 percent with conventional consolidation chemotherapy, and also lengthened survival, so transplant is now the preferred consolidation for fit patients.","summary":"MATRix/IELSG43 was a randomised phase 3 trial of the German and IELSG groups in 368 patients aged 18 to 70 with newly diagnosed primary CNS lymphoma. All received four cycles of MATRix (methotrexate, cytarabine, thiotepa, rituximab); 230 patients with responding or stable disease were randomised to high-dose chemotherapy (carmustine and thiotepa) with autologous stem cell transplant or to two cycles of non-myeloablative R-DeVIC. The primary endpoint was progression-free survival.\n\nAt a median follow-up of 45.3 months three-year progression-free survival was 78 percent after transplant against 51 percent after R-DeVIC (hazard ratio 0.43), and overall survival was also better. Adverse events were more frequent with transplant (14.6 against 9.3 per patient) and five patients died after transplant consolidation against two after R-DeVIC. The corpus's primary CNS lymphoma page cites IELSG43 with IELSG32 for thiotepa-based chemotherapy with autologous transplant.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02531841","url":"https://clinicaltrials.gov/study/NCT02531841"}],"tags":["soc-trials"],"related":["lymphoma-roadmap","ielsg32","prima-cns"],"cancers":["primary-cns-lymphoma","non-hodgkin-lymphoma","brain-tumours"],"sections":[],"technologies":["autologous-stem-cell-transplant","cytotoxic-chemotherapy"],"targets":[],"drugs":["thiotepa","carmustine","rituximab","methotrexate","cytarabine","etoposide","ifosfamide","carboplatin"],"companies":["ielsg"],"institutions":["ccc-freiburg"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-matrix-ielsg43-asct-consolidation-pcnsl-illerhaus-lancet-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02531841","phase":"3","setting":"Newly diagnosed primary central nervous system lymphoma in patients up to 70 responding to four cycles of MATRix induction: consolidation with high-dose carmustine and thiotepa and autologous stem cell transplant against two cycles of non-myeloablative rituximab, dexamethasone, etoposide, ifosfamide and carboplatin (R-DeVIC)","sponsor":"University Hospital Freiburg","result":"Three-year progression-free survival 78 percent after high-dose chemotherapy and autologous transplant against 51 percent after non-myeloablative R-DeVIC (hazard ratio 0.43, p 0.0003), with better overall survival and more toxicity.","started":"2014-07","yearReported":2026,"enrolled":368,"enrolledBasis":"registered","enrolledNote":"The registry gives an estimated 250 and was not updated; the Lancet report enrolled 368 patients, 346 started induction and 230 were randomised (229 analysed).","outcomes":[{"endpoint":"Progression-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"High-dose carmustine-thiotepa and autologous stem cell transplant","n":114,"value":78,"note":"95% CI 69 to 85; median follow-up 45.3 months"},{"name":"R-DeVIC non-myeloablative consolidation","n":115,"value":51,"note":"95% CI 41 to 60"}],"hr":0.43,"ci":[0.27,0.68],"p":"0.0003","source":"https://doi.org/10.1016/S0140-6736(26)00917-7"},{"endpoint":"Mean adverse events per patient","arms":[{"name":"High-dose carmustine-thiotepa and autologous stem cell transplant","n":114,"value":14.6},{"name":"R-DeVIC non-myeloablative consolidation","n":115,"value":9.3}],"source":"https://doi.org/10.1016/S0140-6736(26)00917-7"},{"endpoint":"Fatal serious adverse events after consolidation","unit":"participants","arms":[{"name":"High-dose carmustine-thiotepa and autologous stem cell transplant","n":114,"value":5},{"name":"R-DeVIC non-myeloablative consolidation","n":115,"value":2}],"source":"https://doi.org/10.1016/S0140-6736(26)00917-7"}]},{"id":"matterhorn","kind":"trial","name":"MATTERHORN","aka":[],"tldr":"Adding immunotherapy before and after surgery cut deaths in early stomach cancer; nearly seven in ten patients were alive at three years.","summary":"MATTERHORN, trial NCT04592913 sponsored by AstraZeneca and reported in 2025, showed that adding durvalumab before and after surgery to perioperative FLOT chemotherapy cuts deaths in resectable stage II to IVA gastric and gastro-oesophageal junction adenocarcinoma. It randomised 948 patients, met its primary event-free survival endpoint, nearly tripled the pathologic complete response rate and showed an overall survival benefit at ESMO 2025, leading to FDA approval on 25 November 2025 as the first perioperative immunotherapy in gastric cancer, with benefit consistent across PD-L1 levels. OnCo links it to gastric cancer, PD-L1 as a target, durvalumab, FLOT, the perioperative, pCR and event-free survival terms and Florian Lordick. The trial had no chemotherapy-free arm, and whether FLOT can be de-escalated is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04592913","url":"https://clinicaltrials.gov/study/NCT04592913"}],"tags":[],"related":[],"cancers":["gastric"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1"],"drugs":["durvalumab","flot"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","pcr","efs"],"trials":[],"people":["florian-lordick"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04592913","phase":"3","setting":"Resectable stage II-IVA gastric/GEJ adenocarcinoma: perioperative FLOT + durvalumab vs FLOT + placebo","sponsor":"AstraZeneca","result":"EFS HR 0.71; OS HR 0.78; 3-year OS 68.6%.","started":"2020-11-17","startedType":"actual","yearReported":2025,"enrolled":957,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival","primary":true,"arms":[{"name":"FLOT + durvalumab","n":474},{"name":"FLOT + placebo","n":474}],"hr":0.71,"source":"https://clinicaltrials.gov/study/NCT04592913"},{"endpoint":"Overall survival","arms":[{"name":"FLOT + durvalumab","n":474},{"name":"FLOT + placebo","n":474}],"hr":0.78,"ci":[0.63,0.96],"p":"0.021","source":"https://ascopost.com/issues/december-10-2025-supplement-conference-highlights-esmo-2025/final-overall-survival-confirms-benefit-of-durvalumab-plus-flot-in-resectable-gastric-and-gastroesophageal-junction-adenocarcinomas/"},{"endpoint":"Pathologic complete response","unit":"percent","arms":[{"name":"FLOT + durvalumab","value":19.2},{"name":"FLOT + placebo","value":7.2}],"source":"https://www.cancernetwork.com/view/behind-the-matterhorn-trial-of-durvalumab-flot-in-gastric-gej-cancer"}],"replication":"KEYNOTE-585 (pembrolizumab + chemotherapy) improved pCR but not EFS significantly; MATTERHORN is the only positive perioperative IO trial so far."},{"id":"mavoric","kind":"trial","name":"MAVORIC","aka":[],"tldr":"MAVORIC showed that mogamulizumab, an antibody that clears the malignant T cells that carry the CCR4 protein, kept cutaneous T-cell lymphoma under control for longer than the standard tablet vorinostat, and did especially well in the blood-involved Sezary form, which led to its approval.","summary":"MAVORIC was an open-label phase 3 trial in patients with mycosis fungoides or Sezary syndrome who had failed at least one systemic therapy. Patients were randomised to mogamulizumab, an afucosylated antibody against CCR4 that depletes malignant T cells, or to vorinostat, an approved histone deacetylase inhibitor; patients progressing on vorinostat could cross over.\n\nMogamulizumab significantly prolonged progression-free survival, the primary endpoint, with higher response rates, and the benefit was greatest in patients with blood involvement, the hallmark of Sezary syndrome. It was the first randomised trial in cutaneous T-cell lymphoma to compare two systemic drugs head to head and led to approval of mogamulizumab in the United States in August 2018.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01728805","url":"https://clinicaltrials.gov/study/NCT01728805"}],"tags":["subtype-trials"],"related":[],"cancers":["cutaneous-t-cell-lymphoma","peripheral-t-cell-lymphoma"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["mogamulizumab","vorinostat"],"companies":["kyowa-kirin"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["youn-kim"],"bottlenecks":[],"keyPapers":["paper-mavoric-mogamulizumab-lancet-oncol-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01728805","phase":"3","setting":"Previously treated mycosis fungoides or Sezary syndrome: the anti-CCR4 antibody mogamulizumab against the oral HDAC inhibitor vorinostat, with crossover allowed","sponsor":"Kyowa Kirin","result":"Mogamulizumab improved progression-free survival over vorinostat in previously treated mycosis fungoides and Sezary syndrome; approved in August 2018.","started":"2012-11","startedType":"actual","yearReported":2018,"enrolled":372,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (investigator-assessed)","primary":true,"unit":"months","arms":[{"name":"Mogamulizumab","n":186,"value":7.7},{"name":"Vorinostat","n":186,"value":3.1}],"hr":0.53,"ci":[0.41,0.69],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(18)30379-6"},{"endpoint":"Grade 3-4 adverse events (any cause)","unit":"%","arms":[{"name":"Mogamulizumab","n":184,"value":41},{"name":"Vorinostat","n":186,"value":41}],"source":"https://doi.org/10.1016/S1470-2045(18)30379-6"}]},{"id":"nct01906385","kind":"trial","name":"Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)","aka":["ReSPECT"],"tldr":"A phase 1/2 trial of Rhenium Liposome Treatment in glioma & glioblastoma, run by Cerenome, now recruiting.","summary":"Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT) is a phase 1/2 interventional study registered as NCT01906385 by Cerenome, with 55 participants planned, started 2015-06-03 and due to reach its primary completion in 2025-12. Interventions recorded: Rhenium Liposome Treatment.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01906385","url":"https://clinicaltrials.gov/study/NCT01906385"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["mays-cancer-center"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01906385","phase":"1/2","setting":"A Dual Phase 1/2, Investigator Initiated Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of 186Rhenium Nanoliposomes (186RNL) in Recurrent Glioma (CTRC# 12-02)","sponsor":"Cerenome","started":"2015-06-03","startedType":"actual","enrolled":55,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06534060","kind":"trial","name":"MB-105 in Patients With CD5 Positive T-cell Lymphoma","aka":[],"tldr":"A phase 2 trial of Genetic: MB-105 in non-Hodgkin lymphoma, run by March Biosciences Inc, now recruiting.","summary":"MB-105 in Patients With CD5 Positive T-cell Lymphoma is a phase 2 interventional study registered as NCT06534060 by March Biosciences Inc, with 46 participants planned, started 2025-02-15 and due to reach its primary completion in 2028-02. Interventions recorded: Genetic: MB-105.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06534060","url":"https://clinicaltrials.gov/study/NCT06534060"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06534060","phase":"2","setting":"A Phase 2, Open-label, Multicenter Study of MB-105 in Patients With CD5 Positive (CD5+) Relapsed / Refractory T-cell Lymphoma (r/r TCL).","sponsor":"March Biosciences Inc","started":"2025-02-15","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05655312","kind":"trial","name":"MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma","aka":[],"tldr":"A phase 1/2 trial of Nivolumab in melanoma, run by Perspective Therapeutics, now recruiting.","summary":"MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma is a phase 1/2 interventional study registered as NCT05655312 by Perspective Therapeutics, with 300 participants planned, started 2023-06-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: [203Pb]VMT01, [212Pb]VMT01, Nivolumab. Conditions listed: Recurrent Melanoma (Skin), Metastatic Melanoma, Melanoma Stage IV, Melanoma Stage III. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05655312","url":"https://clinicaltrials.gov/study/NCT05655312"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["perspective-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05655312","phase":"1/2","setting":"A Phase I/IIa, First-In-Human, Multi-Center, Monotherapy and Combination-Therapy With Nivolumab, Dose-Finding and Dose-Expansion Study of [212Pb]VMT01 Melanocortin-1 Receptor-Targeted, Image-Guided Alpha-Particle Therapy in Subjects With Previously Treated Unresectable or Metastatic Melanoma","sponsor":"Perspective Therapeutics","started":"2023-06-01","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04841811","kind":"trial","name":"MDT-bridged Radical Therapy After Aumolertinib With MRD-guided Maintenance in EGFRm+ Unresectable Stage III NSCLC (APPROACH)","aka":["APPROACH"],"tldr":"A phase 3 trial of aumolertinib in lung cancer, run by Guangdong Association of Clinical Trials, active but no longer recruiting.","summary":"MDT-bridged Radical Therapy After Aumolertinib With MRD-guided Maintenance in EGFRm+ Unresectable Stage III NSCLC (APPROACH) is a phase 3, randomised interventional study registered as NCT04841811 by Guangdong Association of Clinical Trials, with a registry enrolment figure of 192 participants, started 2022-06-20 and due to reach its primary completion in 2026-12-31. Interventions recorded: Almonertinib. Conditions listed: Lung Cancer. Primary outcome: Assess the anti-tumor activity by IRC: ORR; Assess the anti-tumor activity by IRC: Event free survival (EFS) rate. Lung eligibility wording from the registry: \"Stage III non-squamous cell non-small cell lung cancer confirmed by histopathology or cytology and determined by the investigator to be unresectable (International Association for the Study of Lung Cancer Eighth Edition Lung Cancer Staging)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04841811","url":"https://clinicaltrials.gov/study/NCT04841811"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["aumolertinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04841811","phase":"3","setting":"Effectiveness and Safety of Dynamic MRD Guiding Treatment After Aumolertinib Induction Therapy of EGFR-mutation-positive Unresectable Stage III Non-Small Cell Lung Cancer in the MDT Diagnostic Model: an Open-label, Multicenter, Randomized, Phase III Study","sponsor":"Guangdong Association of Clinical Trials","started":"2022-06-20","startedType":"actual","enrolled":192,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06483100","kind":"trial","name":"Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance","aka":[],"tldr":"A phase 2 trial of clonoSEQ in Multiple myeloma, run by Washington University School of Medicine, now recruiting.","summary":"Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance is a phase 2 interventional study registered as NCT06483100 by Washington University School of Medicine, with 65 participants planned, started 2024-12-20 and due to reach its primary completion in 2032-06-30. Interventions recorded: Elrantamab, clonoSEQ. Conditions recorded: Multiple Myeloma.\n\nLinked to the drug clonoSEQ because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06483100","url":"https://clinicaltrials.gov/study/NCT06483100"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["clonoseq"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06483100","phase":"2","setting":"Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance","sponsor":"Washington University School of Medicine","started":"2024-12-20","startedType":"actual","enrolled":65,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03925662","kind":"trial","name":"Mebendazole as Adjuvant Treatment for Colon Cancer","aka":[],"tldr":"A phase 3 trial of mebendazole in colorectal cancer, run by Sherief Abd-Elsalam, now recruiting.","summary":"Mebendazole as Adjuvant Treatment for Colon Cancer is a phase 3, randomised interventional study registered as NCT03925662 by Sherief Abd-Elsalam, with a registry enrolment figure of 40 participants, started 2019-04-01 and due to reach its primary completion in 2028-12. Interventions recorded: Folfox with avastin; Mebendazole. Conditions listed: Colorectal Cancer. Primary outcome: number of patients with tumour response. Colorectal eligibility wording from the registry: \"* Colorectal cancer stage 4\". Sites: Egypt. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03925662","url":"https://clinicaltrials.gov/study/NCT03925662"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["mebendazole"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03925662","phase":"3","setting":"Clinical Study Evaluating Mebendazole as Adjuvant Therapy in Patients With Colorectal Cancer","sponsor":"Sherief Abd-Elsalam","started":"2019-04-01","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05463601","kind":"trial","name":"Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer","aka":[],"tldr":"A phase 2 trial of Mecapegfilgrastim and Dalpiciclib in Breast cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, active and no longer recruiting.","summary":"Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer is a phase 2 interventional study registered as NCT05463601 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, with 132 participants planned, started 2022-08-01 and due to reach its primary completion in 2025-01-31. Interventions recorded: Mecapegfilgrastim, dalpiciclib, exemestane, fulvestrant, letrozole, tamoxifen. Conditions recorded: Metastatic Breast Cancer.\n\nLinked to the drug Mecapegfilgrastim because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05463601","url":"https://clinicaltrials.gov/study/NCT05463601"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["mecapegfilgrastim","dalpiciclib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05463601","phase":"2","setting":"Efficacy and Safety of Mecapegfilgrastim for Prophylaxis of Dalpiciclib -Induced Neutropenia in Patients With Advanced HR+/HER2- Breast Cancer: a Open-label, Multicenter, Investigator-initiated, Randomized Controlled Phase II Trial","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","started":"2022-08-01","startedType":"actual","enrolled":132,"enrolledBasis":"registry","outcomes":[]},{"id":"medalist","kind":"trial","name":"MEDALIST","aka":[],"tldr":"MEDALIST showed that luspatercept let a substantial share of people with ring sideroblast myelodysplastic syndromes stop needing blood transfusions after erythropoietin had failed, which earned the drug its first approval.","summary":"MEDALIST randomised 229 patients with very low-, low- or intermediate-risk myelodysplastic syndromes with ring sideroblasts, regular red cell transfusion needs and prior failure of, or unsuitability for, erythropoiesis-stimulating agents to luspatercept or placebo every three weeks. The primary endpoint was red cell transfusion independence for eight weeks or longer in the first 24 weeks.\n\nSignificantly more patients on luspatercept became transfusion independent, many for long periods, with modest toxicity. The drug was approved in the United States in April 2020 for this population, the first new agent for lower-risk myelodysplastic anaemia in over a decade, and COMMANDS then took it into first-line use.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02631070","url":"https://clinicaltrials.gov/study/NCT02631070"}],"tags":["subtype-trials"],"related":[],"cancers":["mds-lower-risk","mds"],"sections":[],"technologies":["transfusion-support"],"targets":[],"drugs":["luspatercept"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["pierre-fenaux"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02631070","phase":"3","setting":"Transfusion-dependent lower-risk myelodysplastic syndromes with ring sideroblasts after failure of or ineligibility for erythropoiesis-stimulating agents: luspatercept against placebo","sponsor":"Celgene (Bristol Myers Squibb)","result":"Luspatercept produced transfusion independence for eight weeks or longer in significantly more patients than placebo; approved in April 2020.","started":"2016-02-09","startedType":"actual","yearReported":2020,"enrolled":229,"enrolledBasis":"registry","outcomes":[{"endpoint":"Transfusion independence >=8 weeks, weeks 1-24","primary":true,"unit":"%","arms":[{"name":"Luspatercept","n":153,"value":38},{"name":"Placebo","n":76,"value":13}],"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1908892"},{"endpoint":"Transfusion independence >=12 weeks, weeks 1-24","unit":"%","arms":[{"name":"Luspatercept","n":153,"value":28},{"name":"Placebo","n":76,"value":8}],"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1908892"},{"endpoint":"Transfusion independence >=12 weeks, weeks 1-48","unit":"%","arms":[{"name":"Luspatercept","n":153,"value":33},{"name":"Placebo","n":76,"value":12}],"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1908892"}]},{"id":"nct06097728","kind":"trial","name":"MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma","aka":["eVOLVE-Meso"],"tldr":"A phase 3 trial of Pemetrexed, Carboplatin, Cisplatin in mesothelioma, run by AstraZeneca, active and no longer recruiting.","summary":"MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma is a phase 3 interventional study registered as NCT06097728 by AstraZeneca, with 863 participants enrolled, started 2023-11-09 and due to reach its primary completion in 2028-11-16. Interventions recorded: Volrustomig, Pemetrexed, Carboplatin, Cisplatin, Nivolumab. Conditions listed: Unresectable Pleural Mesothelioma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06097728","url":"https://clinicaltrials.gov/study/NCT06097728"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mesothelioma","pleural-mesothelioma"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pemetrexed","carboplatin","cisplatin","nivolumab","ipilimumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06097728","phase":"3","setting":"A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination With Carboplatin Plus Pemetrexed Versus Platinum Plus Pemetrexed or Nivolumab Plus Ipilimumab in Participants With Unresectable Pleural Mesothelioma (eVOLVE-Meso)","sponsor":"AstraZeneca","started":"2023-11-09","startedType":"actual","enrolled":863,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06605430","kind":"trial","name":"Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer","aka":["CanPan-C"],"tldr":"A phase 2 trial in pancreatic cancer, run by HealthPartners Institute, now recruiting.","summary":"Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer is a phase 2, randomised interventional study registered as NCT06605430 by HealthPartners Institute, with a registry enrolment figure of 64 participants, started 2024-09-16 and due to reach its primary completion in 2026-09. Interventions recorded: Medical Cannabis. Conditions listed: Pancreatic Cancer Non-resectable; Pancreatic Cancer Metastatic; Colorectal Cancer Metastatic. Primary outcome: Assess feasibility for conducting a larger randomized trial by determining rate of recruitment, compliance with randomization group, and protocol adherence to this clinical trial.. Pancreatic eligibility wording from the registry: \"Histologically or cytologically proven pancreatic or colorectal cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06605430","url":"https://clinicaltrials.gov/study/NCT06605430"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06605430","phase":"2","setting":"A Randomized Phase II Trial of Medical Cannabis to Reduce Symptom Burden in Patients With Advanced Pancreatic and Colorectal Cancer (CanPan-C)","sponsor":"HealthPartners Institute","started":"2024-09-16","startedType":"actual","enrolled":64,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07477808","kind":"trial","name":"Megestrol Acetate for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Hunan Province Tumor Hospital, not yet recruiting.","summary":"Megestrol Acetate for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT07477808 by Hunan Province Tumor Hospital, with a registry enrolment figure of 116 participants, started 2026-04-01 and due to reach its primary completion in 2028-04-01. Interventions recorded: Nanocrystalline Megestrol Acetate Oral Suspension; PD-1/L1 inhibitor combined with chemotherapy. Conditions listed: Non-small Cell Lung Cancer. Primary outcome: change in body weight. Lung eligibility wording from the registry: \"* According to the 8th edition of the Lung Cancer TNM Staging Classification by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC), subjects have histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastat\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07477808","url":"https://clinicaltrials.gov/study/NCT07477808"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07477808","phase":"3","setting":"A Prospective, Randomized, Parallel-Controlled Clinical Study of Megestrol Acetate Oral Suspension for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer","sponsor":"Hunan Province Tumor Hospital","started":"2026-04-01","startedType":"estimated","enrolled":116,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06998758","kind":"trial","name":"Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC","aka":["MATRIX"],"tldr":"A phase 3 trial of progestins (megestrol acetate, medroxyprogesterone, levonorgestrel IUD) in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC is a phase 3, randomised interventional study registered as NCT06998758 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 60 participants, started 2025-11-11 and due to reach its primary completion in 2027-05-10. Interventions recorded: Megestrol Acetate. Conditions listed: Neoadjuvant Chemotherapy; Weight Loss. Primary outcome: Incidence of weight loss. Colorectal eligibility wording from the registry: \"* Histologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06998758","url":"https://clinicaltrials.gov/study/NCT06998758"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["megestrol-progestins"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06998758","phase":"3","setting":"Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Patients With Locally Advanced Colorectal Cancer: A Multicenter Randomized Controlled Clinical Trial","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2025-11-11","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06534437","kind":"trial","name":"MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)","aka":["JASPIS-01"],"tldr":"A phase 2 trial of MEN1703, Glofitamab in hodgkin lymphoma and non-hodgkin lymphoma, run by Ryvu Therapeutics SA, now recruiting.","summary":"MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01) is a phase 2 interventional study registered as NCT06534437 by Ryvu Therapeutics SA, with 178 participants planned, started 2024-12-05 and due to reach its primary completion in 2026-12. Interventions recorded: MEN1703, Glofitamab. Conditions listed: Non-Hodgkin Lymphoma, B-cell. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06534437","url":"https://clinicaltrials.gov/study/NCT06534437"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["men1703","glofitamab"],"companies":["ryvu-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06534437","phase":"2","setting":"An Open Label, Phase 2 Clinical Trial of MEN1703 as Monotherapy and in Combination With Glofitamab in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma","sponsor":"Ryvu Therapeutics SA","started":"2024-12-05","startedType":"actual","enrolled":178,"enrolledBasis":"registry","outcomes":[]},{"id":"mercury","kind":"trial","name":"MERCURY","aka":["Magnetic Resonance Imaging and Rectal Cancer European Equivalence Study"],"tldr":"The study that proved a scan can tell, before any surgery, whether the surgeon will get all of a rectal cancer out, which is why every rectal cancer in the NHS now gets an MRI first.","summary":"MERCURY tested whether high-resolution magnetic resonance imaging could predict the circumferential resection margin, the single strongest predictor of local recurrence after rectal cancer surgery. Of 408 patients, 354 (87 percent) had a clear margin at histopathology. Where the scan predicted a clear margin it was right in 327 of 349 cases (94 percent), and specificity for a clear margin was 92 percent. High-resolution scans were technically satisfactory in 93 percent, and the technique reproduced across centres. That reproducibility is what made MRI staging a national standard: it lets the multidisciplinary team decide before the operation who needs radiotherapy first, which is the decision CR07 and STAR-TREC then refined.","status":"positive","asOf":"2026-09-24","links":[{"label":"BMJ 2006","url":"https://europepmc.org/article/MED/16984925"}],"tags":["uk","rectal","staging","mri"],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":["imaging","surgery"],"technologies":["mri"],"targets":[],"drugs":[],"companies":[],"institutions":["royal-marsden"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"observational","setting":"Prospective observational study of high-resolution preoperative magnetic resonance imaging against the histopathology of the resected specimen, in 408 consecutive patients with rectal cancer treated by colorectal multidisciplinary teams in 11 units in four European countries between January 2002 and October 2003","sponsor":"MERCURY Study Group","result":"Magnetic resonance imaging predicted a clear circumferential resection margin correctly in 327 of 349 patients (94 percent), with 92 percent specificity, reproducibly across 11 units.","yearReported":2006,"enrolled":408,"enrolledBasis":"analysed","enrolledNote":"408 consecutive patients were imaged and operated on in the BMJ 2006 report; the study has no registry record with a separate target.","outcomes":[]},{"id":"mermaid-1","kind":"trial","name":"MERMAID-1","aka":[],"tldr":"A lung cancer trial that planned to test whether adding the immunotherapy durvalumab to chemotherapy after surgery helps people whose blood shows leftover tumour DNA; the registry lists it as complete with 89 participants.","summary":"MERMAID-1 was AstraZeneca's phase 3, double-blind trial of adjuvant durvalumab with platinum chemotherapy in completely resected stage II to III non-small-cell lung cancer, designed around ctDNA-detected minimal residual disease. The registry records a start on 17 July 2020, a status of completed and 89 participants, with primary and study completion on 31 August 2023. Together with MERMAID-2 it is the main example that a ctDNA-selected escalation trial can be hard to run in lung cancer, where adjuvant immunotherapy was approved for all-comers while the trials were recruiting.","status":"completed","asOf":"2026-09-21","links":[{"label":"ClinicalTrials.gov NCT04385368","url":"https://clinicaltrials.gov/study/NCT04385368"}],"tags":["ctdna-roadmap"],"related":["mermaid-2","ctdna-tests"],"cancers":["nsclc"],"sections":[],"technologies":["mrd-testing","liquid-biopsy"],"targets":[],"drugs":["durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["mrd","ctdna"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04385368","phase":"3","setting":"Completely resected stage II to III non-small-cell lung cancer: adjuvant durvalumab plus platinum chemotherapy against placebo plus chemotherapy, with ctDNA-positive patients as the group of interest","sponsor":"AstraZeneca","started":"2020-07-17","startedType":"actual","enrolled":89,"enrolledBasis":"registry","outcomes":[]},{"id":"mermaid-2","kind":"trial","name":"MERMAID-2","aka":[],"tldr":"A lung cancer trial that planned to start durvalumab the moment a surveillance blood test found tumour DNA, before any scan showed relapse; the registry lists it as complete with 30 participants.","summary":"MERMAID-2 was AstraZeneca's phase 3, double-blind trial of durvalumab against placebo for people with stage II to III non-small-cell lung cancer whose ctDNA became detectable during surveillance after curative treatment, the 'treat at molecular relapse' design. The registry records a start on 30 November 2020, a status of completed with 30 participants, primary completion on 31 May 2023 and study completion on 15 January 2024. Its small size is the reason the roadmap describes ctDNA-triggered escalation as unproven outside bladder cancer.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04642469","url":"https://clinicaltrials.gov/study/NCT04642469"}],"tags":["ctdna-roadmap"],"related":["mermaid-1","ctdna-tests"],"cancers":["nsclc"],"sections":[],"technologies":["mrd-testing","liquid-biopsy","continuous-ctdna-monitoring"],"targets":[],"drugs":["durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["mrd","ctdna"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04642469","phase":"3","setting":"Stage II to III non-small-cell lung cancer after surgery and curative treatment: durvalumab against placebo started when ctDNA becomes detectable during surveillance","sponsor":"AstraZeneca","started":"2020-11-30","startedType":"actual","yearReported":2024,"enrolled":30,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free Survival (DFS)","primary":true,"unit":"months","arms":[{"name":"Durvalumab","n":15,"value":3.9,"note":"95% CI 3.515 to NA; Figures from the ClinicalTrials.gov results section (first posted 2024-06-25), not from a publication"},{"name":"Placebo","n":15,"value":2,"note":"95% CI 1.643 to 3.910"}],"source":"https://clinicaltrials.gov/study/NCT04642469?tab=results"}]},{"id":"nct04920149","kind":"trial","name":"Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome","aka":["MesaCAPP"],"tldr":"A phase 2 trial in colorectal cancer, run by Ann-Sofie Backman, now recruiting.","summary":"Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome is a phase 2, randomised interventional study registered as NCT04920149 by Ann-Sofie Backman, with a registry enrolment figure of 150 participants, started 2022-03-21 and due to reach its primary completion in 2032-09-30. Interventions recorded: Mesalamine; Placebo. Conditions listed: Lynch Syndrome; Colon Cancer; Colon Neoplasm. Primary outcome: Change in the occurrence of any colorectal neoplasia in LS patients; Change in the occurrence of any colorectal neoplasia in LS patients. Colorectal eligibility wording from the registry: \"* Presence of colorectal endoscopically non-removable benign neoplasia (patient can be included if the adenoma is removed)\". Sites: Denmark, Sweden. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04920149","url":"https://clinicaltrials.gov/study/NCT04920149"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04920149","phase":"2","setting":"Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome","sponsor":"Ann-Sofie Backman","started":"2022-03-21","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07066995","kind":"trial","name":"Mesothelin and Claudin 18.2 Dual-Target CAR-T Therapy in Advanced Pancreatic Cancer","aka":["BAH2573-102"],"tldr":"A phase 1/2 trial of EB-MF-CAR-NK-01 in pancreatic cancer, run by Essen Biotech, now recruiting.","summary":"Mesothelin and Claudin 18.2 Dual-Target CAR-T Therapy in Advanced Pancreatic Cancer is a phase 1/2, interventional study registered as NCT07066995 by Essen Biotech, with a registry enrolment figure of 60 participants, started 2025-04-29 and due to reach its primary completion in 2027-12-10. Interventions recorded: Mesothelin and Claudin 18.2 CAR-T cells. Conditions listed: Pancreatic Cancer; Pancreatic Carcinoma; Pancreatic Cancer Non-resectable; Pancreatic Cancer Stage IV. Primary outcome: Incidence and severity of dose-limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/BCMA chimeric antigen receptor (CAR) T cells. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed pancreatic adenocarcinoma that is advanced (unresectable or metastatic)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07066995","url":"https://clinicaltrials.gov/study/NCT07066995"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["eb-mf-car-nk-01"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07066995","phase":"1/2","setting":"Dual-Target Chimeric Antigen Receptor (CAR) T-Cell Therapy Directed Against Mesothelin and Claudin 18.2 in Patients With Advanced or Metastatic Pancreatic Cancer","sponsor":"Essen Biotech","started":"2025-04-29","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03223662","kind":"trial","name":"Metabolomic and BH3 Profiling of Esophageal Cancers: Identification of Novel Assessment Methods of Treatment Response for Precision Therapy","aka":[],"tldr":"A phase 2 trial of BH3 profiling in Oesophageal cancer and Oesophageal and junctional adenocarcinoma, run by National Cancer Institute (NCI), recorded as terminated on the registry.","summary":"Metabolomic and BH3 Profiling of Esophageal Cancers: Identification of Novel Assessment Methods of Treatment Response for Precision Therapy is a phase 2 interventional study registered as NCT03223662 by National Cancer Institute (NCI), with 2 participants recorded, started 2017-10-31 and due to reach its primary completion in 2018-07-27. Interventions recorded: Chemoradiotherapy, Esophagectomy. Conditions recorded: Esophageal Cancer, Esophageal Adenocarcinoma, Esophageal Squamous Cell Cancer, Esophageal Neoplasms, Squamous Cell Carcinoma.\n\nLinked to the technology BH3 profiling because the registry's title names it (\"bh3 profiling\") and Oesophageal cancer and Oesophageal and junctional adenocarcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03223662","url":"https://clinicaltrials.gov/study/NCT03223662"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal","oesophageal-adenocarcinoma"],"sections":[],"technologies":["bh3-profiling"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03223662","phase":"2","setting":"Metabolomic and BH3 Profiling of Esophageal Cancers: Identification of Novel Assessment Methods of Treatment Response for Precision Therapy","sponsor":"National Cancer Institute (NCI)","started":"2017-10-31","startedType":"actual","enrolled":2,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06134232","kind":"trial","name":"Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T","aka":["ProvONE"],"tldr":"A phase 2 trial of Sipuleucel-T in prostate cancer, run by Dendreon, now recruiting.","summary":"Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T is a phase 2 interventional study registered as NCT06134232 by Dendreon, with 400 participants planned, started 2023-10-02 and due to reach its primary completion in 2031-12-31. Interventions recorded: Sipuleucel-T Injection. Conditions listed: Metastatic Castration-Resistant Prostate Cancer (mCRPC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06134232","url":"https://clinicaltrials.gov/study/NCT06134232"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["shared-antigen-vaccine"],"targets":[],"drugs":["sipuleucel-t"],"companies":["dendreon"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06134232","phase":"2","setting":"An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response","sponsor":"Dendreon","started":"2023-10-02","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07344220","kind":"trial","name":"Metastatic Non-Familial Adenocarcinoma Maintenance Therapy With DZ-002: Heptamine Carboxymethine Dye Conjugate","aka":["DZ-002-201"],"tldr":"A phase 2 trial in pancreatic cancer, run by Hoag Memorial Hospital Presbyterian, now recruiting.","summary":"Metastatic Non-Familial Adenocarcinoma Maintenance Therapy With DZ-002: Heptamine Carboxymethine Dye Conjugate is a phase 2, interventional study registered as NCT07344220 by Hoag Memorial Hospital Presbyterian, with a registry enrolment figure of 39 participants, started 2026-03-05 and due to reach its primary completion in 2028-11. Interventions recorded: DZ-002 - 5 mg/kg, 6 mg/kg, or 7 mg/kg. Conditions listed: Metastatic Pancreatic Adenocarcinoma; Pancreatic Cancer. Primary outcome: Recommended Phase 2 Dose (RP2D); Incidence of Dose Limiting Toxicities (DLTs). Pancreatic eligibility wording from the registry: \"Histopathologically confirmed diagnosis of metastatic pancreatic adenocarcinoma who completed 4 months or more of first line chemotherapy and have achieved at least SD documented by CT scan\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07344220","url":"https://clinicaltrials.gov/study/NCT07344220"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07344220","phase":"2","setting":"Metastatic Non-Familial Adenocarcinoma Maintenance Therapy With DZ-002: Heptamine Carboxymethine Dye Conjugate","sponsor":"Hoag Memorial Hospital Presbyterian","started":"2026-03-05","startedType":"actual","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06826092","kind":"trial","name":"Metformin for the Treatment of mCRC Patients Undergoing FOLFIRI Plus Target Therapy","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital, now recruiting.","summary":"Metformin for the Treatment of mCRC Patients Undergoing FOLFIRI Plus Target Therapy is a phase 2, randomised interventional study registered as NCT06826092 by Kaohsiung Medical University Chung-Ho Memorial Hospital, with a registry enrolment figure of 110 participants, started 2022-10-31 and due to reach its primary completion in 2025-12-31. Interventions recorded: Metformin Pill; FOLFIRI plus target therapy only. Conditions listed: Progression-Free Survival. Primary outcome: Disease progression-free survival (PFS). Colorectal eligibility wording from the registry: \"Patients diagnosed with metastatic colorectal cancer who is going to receive FOLFIRI chemotherapy\". Sites: Taiwan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06826092","url":"https://clinicaltrials.gov/study/NCT06826092"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06826092","phase":"2","setting":"Metformin as an Adjunctive Therapy for the Treatment of Metastatic Colorectal Cancer Patients Undergoing FOLFIRI Plus Target Therapy","sponsor":"Kaohsiung Medical University Chung-Ho Memorial Hospital","started":"2022-10-31","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05445791","kind":"trial","name":"Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations","aka":["METLUNG"],"tldr":"A phase 3 trial in lung cancer, run by Instituto Nacional de Cancerologia de Mexico, now recruiting.","summary":"Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations is a phase 3, randomised interventional study registered as NCT05445791 by Instituto Nacional de Cancerologia de Mexico, with a registry enrolment figure of 312 participants, started 2021-07-15 and due to reach its primary completion in 2026-07-14. Interventions recorded: Metformin Hydrochloride; Placebo. Conditions listed: Non Small Cell Lung Cancer. Primary outcome: Progression-free survival. Lung eligibility wording from the registry: \"Patients with a histologically confirmed diagnosis of non-small cell lung cancer (stage IIIB-IV) according to the American Joint Committee on Cancer (AJCC) eight edition\". Sites: Mexico. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05445791","url":"https://clinicaltrials.gov/study/NCT05445791"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05445791","phase":"3","setting":"Effect of Metformin Plus Tyrosine Kinase Inhibitors Compared With Tyrosine Kinase Inhibitors Alone for Patients With Advanced Non-small Cell Lung Cancer and EGFR Mutations: Phase 3 Randomized Clinical Trial","sponsor":"Instituto Nacional de Cancerologia de Mexico","started":"2021-07-15","startedType":"actual","enrolled":312,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01188798","kind":"trial","name":"Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies","aka":[],"tldr":"A phase 3 trial of Methotrexate and Pentostatin in Acute lymphoblastic leukaemia and Leukaemia, run by St. Jude Children's Research Hospital, completed.","summary":"Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies is a phase 3 interventional study registered as NCT01188798 by St. Jude Children's Research Hospital, with 6 participants recorded, started 2010-09 and reaching its primary completion in 2012-02. Interventions recorded: Methotrexate, Pentostatin. Conditions recorded: Acute Lymphoblastic Leukemia, Acute Myelocytic Leukemia, Chronic Myelocytic Leukemia, Hodgkin's Disease, Myelodysplastic Syndrome.\n\nLinked to the drug Pentostatin because the registry names it among its interventions and Acute lymphoblastic leukaemia and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01188798","url":"https://clinicaltrials.gov/study/NCT01188798"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["methotrexate","pentostatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01188798","phase":"3","setting":"Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies","sponsor":"St. Jude Children's Research Hospital","started":"2010-09","enrolled":6,"enrolledBasis":"registry","outcomes":[]},{"id":"metro-plus-varanasi","kind":"trial","name":"METRO PLUS (Tata Memorial Centre, Varanasi)","aka":[],"tldr":"Adding low-cost oral metronomic tablets to standard paclitaxel-carboplatin doubled median survival from 5 to 10 months in a randomised trial run in Varanasi.","summary":"238 patients (119 per arm) with advanced unresectable head and neck cancer were randomised to paclitaxel-carboplatin plus oral metronomic chemotherapy or paclitaxel-carboplatin alone. Median overall survival was 10 months with the combination versus 5 months with chemotherapy alone (hazard ratio 0.54; 95% CI 0.41-0.72; P<0.001). Published in JCO Global Oncology in 2026 and framed by its authors as a trial addressing global cancer care equity, it extends the Tata Memorial metronomic programme to the Gangetic plain and to patients fit for platinum doublets.","status":"positive","asOf":"2026-09-10","links":[{"label":"Kapoor et al., JCO Global Oncology 2026","url":"https://doi.org/10.1200/GO-25-00721"}],"tags":[],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc","buccal-mucosa-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["paclitaxel","carboplatin","methotrexate"],"companies":[],"institutions":["homi-bhabha-cancer-hospital-varanasi","tata-memorial"],"pathways":[],"terms":[],"trials":["metronomic-vs-cisplatin-tmh"],"people":["kapoor-akhil"],"bottlenecks":["b-generic-repurposing","b-global-access"],"keyPapers":["paper-kapoor-jco-glob-oncol"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Advanced unresectable head and neck cancer: paclitaxel-carboplatin with or without oral metronomic chemotherapy","sponsor":"Tata Memorial Centre (Homi Bhabha Cancer Hospital and MPMMCC, Varanasi)","result":"Median OS 10 vs 5 months, HR 0.54.","yearReported":2026,"enrolled":238,"enrolledBasis":"registry","outcomes":[{"endpoint":"Median overall survival","primary":true,"unit":"months","arms":[{"name":"Paclitaxel-carboplatin + oral metronomic chemotherapy","n":119,"value":10},{"name":"Paclitaxel-carboplatin","n":119,"value":5}],"hr":0.54,"ci":[0.41,0.72],"p":"<0.001","source":"https://doi.org/10.1200/GO-25-00721"}]},{"id":"nct05748145","kind":"trial","name":"Metronidazole as Preoperative Therapy in CRC / FusoMetro-001","aka":["FusoMetro-001"],"tldr":"A phase 2 trial in colorectal cancer, run by Oncology Institute of Southern Switzerland, now recruiting.","summary":"Metronidazole as Preoperative Therapy in CRC / FusoMetro-001 is a phase 2, interventional study registered as NCT05748145 by Oncology Institute of Southern Switzerland, with a registry enrolment figure of 40 participants, started 2023-09-11 and due to reach its primary completion in 2026-12-31. Interventions recorded: Metronidazole Oral. Conditions listed: Colorectal Cancer. Primary outcome: Impact of metronidazole on F.n. loads in CRC tissues.. Colorectal eligibility wording from the registry: \"* Untreated, primary colorectal adenocarcinoma (\\> 15 cm from the anal verge)\". Sites: Switzerland. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05748145","url":"https://clinicaltrials.gov/study/NCT05748145"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05748145","phase":"2","setting":"Preoperative Treatment With Metronidazole to Evaluate the Efficacy in Reducing Fusobacterium Nucleatum Tumor Colonization in Patients With Colorectal Cancer (CRC): a Proof-of-concept Trial","sponsor":"Oncology Institute of Southern Switzerland","started":"2023-09-11","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06759090","kind":"trial","name":"Metronomic Capecitabine with Camrelizumab and Apatinib Mesylate for Treatment of Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of camrelizumab in pancreatic cancer, run by Zhejiang University, not yet recruiting.","summary":"Metronomic Capecitabine with Camrelizumab and Apatinib Mesylate for Treatment of Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT06759090 by Zhejiang University, with a registry enrolment figure of 43 participants, started 2025-01-15 and due to reach its primary completion in 2027-01-15. Interventions recorded: Metronomic capecitabine; Camrelizumab; Apatinib Mesylate Tablets. Conditions listed: Metastatic Pancreatic Carcinoma. Primary outcome: Objective Response Rate (ORR); Disease Control Rate (DCR); Safety of treatment. Pancreatic eligibility wording from the registry: \"* 1: Age is 18 years or older; 2: Pathologically confirmed pancreatic adenocarcinoma; 3: As determined by the investigator, second-line treatment for advanced pancreatic cancer has failed; or the patient has a poor performance status (PS score \\>1), and the investigator considers that the patient ca\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06759090","url":"https://clinicaltrials.gov/study/NCT06759090"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["camrelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06759090","phase":"2","setting":"Metronomic Capecitabine with Camrelizumab and Apatinib Mesylate in Advanced Pancreatic Cancer：A Multi-center, Single-arm, Phase II Exploratory Trial","sponsor":"Zhejiang University","started":"2025-01-15","startedType":"estimated","enrolled":43,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05929885","kind":"trial","name":"Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by National Cancer Centre, Singapore, now recruiting.","summary":"Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients is a phase 2, interventional study registered as NCT05929885 by National Cancer Centre, Singapore, with a registry enrolment figure of 50 participants, started 2023-08-30 and due to reach its primary completion in 2027-02-28. Interventions recorded: Low Dose OXIRI (LD-OXIRI). Conditions listed: Metastatic Pancreatic Cancer. Primary outcome: Overall Response Rate (ORR).; Clinical Benefit Rate (CBR).; The Grade 3-5 Toxicity Rate.. Pancreatic eligibility wording from the registry: \"Histopathological diagnosis of pancreatic cancer\". Sites: Singapore. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05929885","url":"https://clinicaltrials.gov/study/NCT05929885"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05929885","phase":"2","setting":"A Phase II Study of Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients.","sponsor":"National Cancer Centre, Singapore","started":"2023-08-30","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"mevpro-1","kind":"trial","name":"MEVPRO-1","aka":[],"tldr":"MEVPRO-1 is the phase 3 trial of the first EZH2 inhibitor combination in prostate cancer.","summary":"MEVPRO-1, trial NCT06551324 sponsored by Pfizer, is the phase 3 trial of the first EZH2 inhibitor combination in prostate cancer, testing mevrometostat plus enzalutamide against physician's choice of enzalutamide or docetaxel in metastatic castration-resistant prostate cancer after abiraterone. It enrols about 600 men in an open-label design with radiographic progression-free survival as the primary endpoint; the first patient was dosed in October 2024 and completion is projected for 2028, while MEVPRO-2, a double-blind trial, and MEVPRO-3 in castration-sensitive disease run in parallel. OnCo links it to EZH2 as a target and to mevrometostat and enzalutamide. There are no results, and whether epigenetic reversal of androgen receptor resistance works in patients is the question the programme exists to answer. Mevrometostat has its own page.","status":"active","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT06551324","url":"https://clinicaltrials.gov/study/NCT06551324"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["epigenetic-drugs"],"targets":["ezh2"],"drugs":["mevrometostat","enzalutamide"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06551324","phase":"3","setting":"mCRPC after abiraterone: mevrometostat + enzalutamide vs physician's choice (enzalutamide or docetaxel)","sponsor":"Pfizer","started":"2024-10-21","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing phase 3 of mevrometostat + enzalutamide; no results."},{"id":"nct04084496","kind":"trial","name":"mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients","aka":[],"tldr":"A phase 2 trial of fOLFIRINOX / mFOLFIRINOX in pancreatic cancer, run by Sun Yat-sen University, now recruiting.","summary":"mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients is a phase 2, interventional study registered as NCT04084496 by Sun Yat-sen University, with a registry enrolment figure of 80 participants, started 2019-09-01 and due to reach its primary completion in 2024-12-31. Interventions recorded: Folfirinox. Conditions listed: Pancreatic Cancer. Primary outcome: Disease free survival. Pancreatic eligibility wording from the registry: \"* Histologically confirmed adenocarcinoma of the pancreas without distant metastases\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04084496","url":"https://clinicaltrials.gov/study/NCT04084496"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfirinox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04084496","phase":"2","setting":"A Phase II Study With mFOLFIRINOX as Adjuvent Chemotherapy for Resectable Pancreas Carcinoma","sponsor":"Sun Yat-sen University","started":"2019-09-01","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06761027","kind":"trial","name":"mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of anlotinib and sintilimab in pancreatic cancer, run by Fujian Provincial Hospital, now recruiting.","summary":"mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer is a phase 1/2, interventional study registered as NCT06761027 by Fujian Provincial Hospital, with a registry enrolment figure of 29 participants, started 2024-12-23 and due to reach its primary completion in 2027-03. Interventions recorded: Anlotinib combined with Sintilimab. Conditions listed: Locally Advanced Pancreatic Cancer; Metastatic Pancreatic Cancer. Primary outcome: Objective response rate, ORR. Pancreatic eligibility wording from the registry: \"Patients with locally advanced or metastatic pancreatic cancer diagnosed by histology or cytology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06761027","url":"https://clinicaltrials.gov/study/NCT06761027"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["anlotinib","sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06761027","phase":"1/2","setting":"mFOLFIRINOX Combined With Anlotinib and Sintilimab as First-Line Therapy for Locally Advanced or Metastatic Pancreatic Cancer: A Prospective, Single-arm, Multicenter, Phase Ib/II Clinical Study","sponsor":"Fujian Provincial Hospital","started":"2024-12-23","startedType":"actual","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06149689","kind":"trial","name":"mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer","aka":["PTCA199-7"],"tldr":"A phase 2 trial in pancreatic cancer, run by Fudan University, now recruiting.","summary":"mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT06149689 by Fudan University, with a registry enrolment figure of 30 participants, started 2024-01-10 and due to reach its primary completion in 2025-10-31. Interventions recorded: mFOLFIRINOX plus radiotherapy. Conditions listed: Pancreatic Adenocarcinoma. Primary outcome: Overall survival，OS. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed advanced pancreas adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06149689","url":"https://clinicaltrials.gov/study/NCT06149689"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06149689","phase":"2","setting":"mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer","sponsor":"Fudan University","started":"2024-01-10","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06249321","kind":"trial","name":"mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer Refractory to Chemotherapy","aka":["PTCA199-10"],"tldr":"A phase 2 trial in pancreatic cancer, run by Fudan University, now recruiting.","summary":"mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer Refractory to Chemotherapy is a phase 2, interventional study registered as NCT06249321 by Fudan University, with a registry enrolment figure of 30 participants, started 2024-04-01 and due to reach its primary completion in 2026-03-01. Interventions recorded: mFOLFIRINOX plus IMRT. Conditions listed: Pancreatic Cancer; Radiotherapy. Primary outcome: progression-free survival, PFS. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed advanced pancreas adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06249321","url":"https://clinicaltrials.gov/study/NCT06249321"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06249321","phase":"2","setting":"mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer Refractory to Chemotherapy","sponsor":"Fudan University","started":"2024-04-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07062536","kind":"trial","name":"mFOLFOX/mFOLFIRI vs. mFOLFOX in Advanced or Recurrent Biliary Tract Cancer Second-line","aka":[],"tldr":"A phase 2 trial of oxaliplatin, leucovorin, FOLFOX and other drugs in gallbladder cancer and other biliary tract cancers, run by Seoul National University Bundang Hospital, now recruiting.","summary":"mFOLFOX/mFOLFIRI vs. mFOLFOX in Advanced or Recurrent Biliary Tract Cancer Second-line is a phase 2, randomised interventional study registered as NCT07062536 by Seoul National University Bundang Hospital, with a registry enrolment figure of 130 participants, started 2025-08-27 and due to reach its primary completion in 2027-04-01. Interventions recorded: Oxaliplatin, 5FU, leucovorin, Oxaliplatin, 5FU, leucovorin/Irinotecan , 5FU, leucovorin,. Conditions listed: Biliary Cancer Metastatic. Gallbladder cancer is named in the registry entry: \"2. Diagnosed with biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, or ampulla of Vater cancer.\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07062536","url":"https://clinicaltrials.gov/study/NCT07062536"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["oxaliplatin","leucovorin","folfox","folfiri","irinotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07062536","phase":"2","setting":"A Randomized Phase II Clinical Trial to Evaluate the Efficacy Alternating mFOLFOX/mFOLFIRI Chemotherapy Regimen as a Second-line Treatment for Advanced Biliary Tract Cancer","sponsor":"Seoul National University Bundang Hospital","started":"2025-08-27","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06791512","kind":"trial","name":"mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody Vs. mFOLFOX6 in Locally Advanced pMMR/MSS CRC","aka":["BASKETIII"],"tldr":"A phase 3 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Jun Huang, now recruiting.","summary":"mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody Vs. mFOLFOX6 in Locally Advanced pMMR/MSS CRC is a phase 3, randomised interventional study registered as NCT06791512 by Jun Huang, with a registry enrolment figure of 166 participants, started 2025-01-18 and due to reach its primary completion in 2030-12-31. Interventions recorded: mFOLFOX6 + Bevacizumab + PD-1 monoclonal antibody; mFOLFOX6. Conditions listed: Colorectal Cancer (CRC); pMMR/MSS Adenocarcinoma of the Colon or Rectum. Primary outcome: 3 years DFS Rate. Colorectal eligibility wording from the registry: \"Histologically confirmed adenocarcinoma of the colon or upper rectum\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06791512","url":"https://clinicaltrials.gov/study/NCT06791512"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06791512","phase":"3","setting":"mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody Versus mFOLFOX6 as Neoadjuvant Therapy for Locally Advanced pMMR/MSS Colorectal Cancer: A Prospective, Multicenter, Randomized Phase III Study (BASKETIII)","sponsor":"Jun Huang","started":"2025-01-18","startedType":"actual","enrolled":166,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07817888","kind":"trial","name":"mFOLFOXIRI Plus Bevacizumab for Organ Preservation in Locally Advanced Rectal Cancer","aka":["FOBEAR-ii"],"tldr":"A phase 2 trial of FOLFOXIRI in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, not yet recruiting.","summary":"mFOLFOXIRI Plus Bevacizumab for Organ Preservation in Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT07817888 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 119 participants, started 2026-09-30 and due to reach its primary completion in 2028-09-30. Interventions recorded: FOLFOXIRI + Bevacizumab. Conditions listed: Phase 2 Study. Primary outcome: 3-year Disease Free Survival. Colorectal eligibility wording from the registry: \"* Histologically confirmed rectal adenocarcinoma;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07817888","url":"https://clinicaltrials.gov/study/NCT07817888"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfoxiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07817888","phase":"2","setting":"Neoadjuvant mFOLFOXIRI Plus Bevacizumab for Organ Preservation in Locally Advanced Rectal Cancer: A Singe-arm Phase II Study","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2026-09-30","startedType":"estimated","enrolled":119,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06890624","kind":"trial","name":"mFOLFOXIRI Plus PD-1 Inhibitor vs mFOLFOX6 as Neoadjuvant Therapy for Locally Advanced Colon Cancer","aka":["OPTICAL-3"],"tldr":"A phase 2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"mFOLFOXIRI Plus PD-1 Inhibitor vs mFOLFOX6 as Neoadjuvant Therapy for Locally Advanced Colon Cancer is a phase 2, randomised interventional study registered as NCT06890624 by Sun Yat-sen University, with a registry enrolment figure of 138 participants, started 2026-10-01 and due to reach its primary completion in 2029-10-01. Interventions recorded: cmFOLFOXIRI plus PD-1 inhibitor; mFOLFOX6. Conditions listed: Colon Cancer (Stage II &Amp;Amp; III). Primary outcome: Pathologic complete response rate. Colorectal eligibility wording from the registry: \"Histological or cytological documentation of adenocarcinoma of the colon (≥ 12 cm from the anal verge)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06890624","url":"https://clinicaltrials.gov/study/NCT06890624"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06890624","phase":"2","setting":"Chinese Modified FOLFOXIRI Combined With PD-1 Inhibitor Versus mFOLFOX6 as Neoadjuvant Therapy for Locally Advanced Colon Cancer (cT4/N2): A Multicenter, Randomized, Controlled, Phase II Trial","sponsor":"Sun Yat-sen University","started":"2026-10-01","startedType":"estimated","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05296681","kind":"trial","name":"Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery","aka":["NBT-NM108"],"tldr":"A phase 2 trial in colorectal cancer, run by Howard S. Hochster, MD, now recruiting.","summary":"Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery is a phase 2, randomised interventional study registered as NCT05296681 by Howard S. Hochster, MD, with a registry enrolment figure of 42 participants, started 2022-05-03 and due to reach its primary completion in 2026-12. Interventions recorded: NBT-NM108. Conditions listed: Metastatic Colon Carcinoma; Stage IV Colon Cancer AJCC v8; Stage IVA Colon Cancer AJCC v8; Stage IVB Colon Cancer AJCC v8; Stage IVC Colon Cancer AJCC v8. Primary outcome: The number of participants with treatment-related Adverse Events as Assessed by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTCAE) Version 5.0 for toxicity and Adverse Event reporting; Tumor Response by RECIST v1.1 Criteria. Colorectal eligibility wording from the registry: \"* Biopsy proven and metastatic colon cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05296681","url":"https://clinicaltrials.gov/study/NCT05296681"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05296681","phase":"2","setting":"A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery","sponsor":"Howard S. Hochster, MD","started":"2022-05-03","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04771871","kind":"trial","name":"MicroRNA Profiles in Triple Negative Breast Cancer","aka":["TARMAC"],"tldr":"A phase 2 trial of epirubicin, cyclophosphamide, paclitaxel / nab-paclitaxel and carboplatin in triple-negative breast cancer, run by University College Hospital, Ibadan, now recruiting.","summary":"MicroRNA Profiles in Triple Negative Breast Cancer is a phase 2, interventional study registered as NCT04771871 by University College Hospital, Ibadan, with a registry enrolment figure of 42 participants, started 2021-11-29 and due to reach its primary completion in 2027-03. Interventions recorded: Epirubicin; Cyclophosphamide; Paclitaxel; Carboplatin. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Patients with histologically confirmed carcinoma of the female breast with triple negative status by immuno-histochemistry (IHC)\". Sites: Nigeria. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04771871","url":"https://clinicaltrials.gov/study/NCT04771871"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["epirubicin","cyclophosphamide","paclitaxel","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04771871","phase":"2","setting":"Treatment Response and microRNA Profiles in Triple Negative Breast Cancer Patients Receiving Standard Chemotherapy","sponsor":"University College Hospital, Ibadan","started":"2021-11-29","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03643133","kind":"trial","name":"Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients","aka":[],"tldr":"A phase 2 trial of Mifamurtide in Osteosarcoma, run by UNICANCER, active and no longer recruiting.","summary":"Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients is a phase 2 interventional study registered as NCT03643133 by UNICANCER, with 60 participants planned, started 2018-10-23 and due to reach its primary completion in 2026-09. Interventions recorded: Mifamurtide, EI or M-API regimen depending on patient age. Conditions recorded: Osteosarcoma.\n\nLinked to the drug Mifamurtide because the registry names it among its interventions and Osteosarcoma among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03643133","url":"https://clinicaltrials.gov/study/NCT03643133"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["osteosarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["mifamurtide"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03643133","phase":"2","setting":"Multicentre, Randomised, Phase 2 Trial of Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients (Metastatic Osteosarcoma at Diagnosis or Localised Disease With Poor Histological Response)","sponsor":"UNICANCER","started":"2018-10-23","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04834024","kind":"trial","name":"MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma","aka":[],"tldr":"A phase 3 trial of Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide in follicular lymphoma, run by Beijing Mabworks Biotech Co., Ltd., now recruiting.","summary":"MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma is a phase 3 interventional study registered as NCT04834024 by Beijing Mabworks Biotech Co., Ltd., with 168 participants planned, started 2021-06-02 and due to reach its primary completion in 2025-03. Interventions recorded: Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide and lenalinomide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04834024","url":"https://clinicaltrials.gov/study/NCT04834024"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["beijing-mabworks-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04834024","phase":"3","setting":"A Multi-center, Open Label, Phase III Study to Evaluate the Efficacy and Safety of MIL62 Plus Lenalidomide Versus Lenalidomide in Subjects With Follicular Lymphoma Refractory to Rituximab","sponsor":"Beijing Mabworks Biotech Co., Ltd.","started":"2021-06-02","startedType":"actual","enrolled":168,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04110301","kind":"trial","name":"MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)","aka":[],"tldr":"A phase 1/2 trial of Lenalidomide in follicular lymphoma, run by Beijing Mabworks Biotech Co., Ltd., now recruiting.","summary":"MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL) is a phase 1/2 interventional study registered as NCT04110301 by Beijing Mabworks Biotech Co., Ltd., with 53 participants planned, started 2019-11-28 and due to reach its primary completion in 2024-01-09. Interventions recorded: Recombinant Humanized Monoclonal Antibody MIL62 Injection, Lenalidomide. Conditions listed: Follicular Lymphoma and Marginal Zone Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04110301","url":"https://clinicaltrials.gov/study/NCT04110301"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["protac-degrader"],"targets":[],"drugs":["lenalidomide"],"companies":["beijing-mabworks-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04110301","phase":"1/2","setting":"A Multi-center, Open Label, Phase 1b/2 Study to Study the Efficacy and Safety of MIL62 Plus Lenalidomide in Subjects With Relapsed/Refractory Follicular Lymphoma or Marginal Zone Lymphoma","sponsor":"Beijing Mabworks Biotech Co., Ltd.","started":"2019-11-28","startedType":"actual","enrolled":53,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06534762","kind":"trial","name":"Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Zhejiang Provincial People's Hospital, now recruiting.","summary":"Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study is a phase 2, interventional study registered as NCT06534762 by Zhejiang Provincial People's Hospital, with a registry enrolment figure of 260 participants, started 2024-07-15 and due to reach its primary completion in 2026-07-01. Interventions recorded: Mirabegron. Conditions listed: NSCLC; SCLC; Colorectal Cancer; Pancreas Cancer; TNBC - Triple-Negative Breast Cancer; DLBCL - Diffuse Large B Cell Lymphoma; Squamous Cell Carcinoma of Head and Neck. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06534762","url":"https://clinicaltrials.gov/study/NCT06534762"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06534762","phase":"2","setting":"Efficacy and Safety of Milaberon in Combination With Standard Therapy in Advanced Solid Tumors: an Open, Multicenter, Clinical Study","sponsor":"Zhejiang Provincial People's Hospital","started":"2024-07-15","startedType":"actual","enrolled":260,"enrolledBasis":"registry","outcomes":[]},{"id":"milan-i","kind":"trial","name":"Milan I (quadrantectomy against radical mastectomy)","aka":["Milan trial","Veronesi quadrantectomy trial","QUART"],"tldr":"Umberto Veronesi ran the European half of the argument, against the most mutilating operation in surgery. After twenty years, women who had a quarter of the breast removed and radiotherapy were as likely to be alive as women who had the breast, the chest muscles and the nodes taken away.","summary":"Between 1973 and 1980, 701 women with breast cancers of 2 cm or less were randomised at the Istituto Nazionale Tumori in Milan to Halsted radical mastectomy (349) or to quadrantectomy with axillary dissection followed by radiotherapy to the remaining breast tissue (352). From 1976 node-positive women in both arms received cyclophosphamide, methotrexate and fluorouracil.\n\nAt twenty years, thirty women in the conservation arm had a recurrence in the same breast against eight in the mastectomy arm, a crude cumulative incidence of 8.8 against 2.3 percent (p<0.001). Nothing else differed: contralateral breast cancers, distant metastases and second primary cancers were the same in both arms. Death from any cause was 41.7 percent after conservation and 41.2 percent after radical mastectomy (p=1.0); death from breast cancer 26.1 against 24.3 percent (p=0.8).\n\nRead alongside NSABP B-06, Milan I is the reason the sentence \"breast conservation is the treatment of choice for relatively small breast cancers\" can be written at all. It also shows the shape of the trade: a higher chance of the cancer returning in the breast, paid for by keeping the breast, with no cost in life. Quadrantectomy itself, which takes a whole quadrant, is more than most surgeons remove now, and the 8.8 percent figure was achieved without the modern systemic therapy that lowers local recurrence further.","status":"positive","asOf":"2026-09-25","links":[{"label":"Milan I twenty-year follow-up (New England Journal of Medicine 2002)","url":"https://doi.org/10.1056/NEJMoa020989"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["ieo-milan"],"pathways":[],"terms":["lumpectomy","mastectomy","breast-conserving-surgery-versus-mastectomy","oncoplastic-breast-surgery"],"trials":["nsabp-b06","eortc-10801"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Breast cancer 2 cm or smaller: Halsted radical mastectomy against quadrantectomy with axillary dissection and breast radiotherapy, with long-term survival as the endpoint","sponsor":"Istituto Nazionale Tumori, Milan","result":"Twenty-year same-breast recurrence 8.8 percent after quadrantectomy against 2.3 percent after radical mastectomy, with identical survival (death from any cause 41.7 against 41.2 percent, p=1.0).","yearReported":2002,"enrolled":701,"enrolledBasis":"randomised","enrolledNote":"The trial randomised 701 women between 1973 and 1980, before any trial registry existed, so there is no registry figure.","outcomes":[{"endpoint":"Crude cumulative incidence of ipsilateral breast recurrence at 20 years","primary":true,"unit":"%","arms":[{"name":"Quadrantectomy with radiotherapy","n":352,"value":8.8},{"name":"Halsted radical mastectomy","n":349,"value":2.3}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa020989"},{"endpoint":"Death from any cause at 20 years","unit":"%","arms":[{"name":"Quadrantectomy with radiotherapy","n":352,"value":41.7},{"name":"Halsted radical mastectomy","n":349,"value":41.2}],"p":"1.0","source":"https://doi.org/10.1056/NEJMoa020989"},{"endpoint":"Death from breast cancer at 20 years","unit":"%","arms":[{"name":"Quadrantectomy with radiotherapy","n":352,"value":26.1},{"name":"Halsted radical mastectomy","n":349,"value":24.3}],"p":"0.8","source":"https://doi.org/10.1056/NEJMoa020989"}],"replication":"NSABP B-06 reached the same conclusion in a North American population with a smaller operation; EORTC 10801 confirmed it at twenty years against modified radical mastectomy."},{"id":"mimic-01","kind":"trial","name":"MIMic-01: healthy-donor FMT plus anti-PD-1, first-line melanoma","aka":[],"tldr":"Twenty melanoma patients took stool capsules from healthy donors before starting immunotherapy. Thirteen responded, more than usually expected, and the transplant was safe.","summary":"Phase 1 safety trial of healthy-donor capsule FMT (about 80-100 capsules, single dose) combined with first-line anti-PD-1. Objective response rate was 65% (13 of 20), including 4 complete responses, versus a historical 40-45% for anti-PD-1 monotherapy; responders had greater engraftment of donor strains and increased abundance of immunogenic taxa. Grade 3 immune-related adverse events occurred in 5 patients, none attributed to FMT. The trial moved FMT from a salvage strategy to a potential first-line adjunct and led to the Canadian Cancer Trials Group randomised phase 2 (LND101, NCT06623461). The historical comparison is not a control and the sample is small.","status":"active","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT03772899","url":"https://clinicaltrials.gov/study/NCT03772899"},{"label":"Routy et al. (Nat Med 2023)","url":"https://doi.org/10.1038/s41591-023-02453-x"},{"label":"ClinicalTrials.gov NCT06623461","url":"https://clinicaltrials.gov/study/NCT06623461"}],"tags":[],"related":["idea-bio2-fmt-plus-checkpoint-phase3"],"cancers":["melanoma"],"sections":["nutrition-lifestyle","immunotherapy"],"technologies":["fmt-checkpoint-nonresponders","microbiome-modulation-io","checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","pembrolizumab"],"companies":[],"institutions":[],"pathways":["microbiome-tumour"],"terms":["gut-microbiome-diversity","orr"],"trials":[],"people":[],"bottlenecks":["b-immunotherapy-response"],"keyPapers":["paper-mimic-01-nat-med-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03772899","phase":"1","setting":"Untreated advanced melanoma: oral capsule FMT from healthy donors one week before, then with, nivolumab or pembrolizumab","sponsor":"Centre hospitalier de l'Universite de Montreal / Lawson Health Research Institute","result":"ORR 65% (13 of 20), 4 complete responses; no FMT-related serious adverse events.","started":"2019-03-27","startedType":"actual","yearReported":2023,"enrolled":20,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"FMT + anti-PD-1","n":20,"value":65}],"source":"https://doi.org/10.1038/s41591-023-02453-x"}],"replication":"Randomised phase 2 (LND101, NCT06623461) recruiting."},{"id":"mindact","kind":"trial","name":"MINDACT","aka":[],"tldr":"MINDACT showed that women whose early breast cancer looked high-risk to doctors but low-risk on the 70-gene MammaPrint test could skip chemotherapy: those who did met the trial's prespecified safety threshold, and about 46% of clinically high-risk women could avoid chemotherapy. Women aged 50 or under may still gain from it.","summary":"Among 6,693 women, 1,550 had high clinical risk but low genomic risk by MammaPrint; those randomised to no chemotherapy had 5-year distant metastasis-free survival of 94.7% (NEJM 2016), meeting the prespecified threshold, with a 1.5 percentage point difference versus chemotherapy that was not statistically significant. The 8-year update (Lancet Oncology 2021) confirmed the finding, with a suggestion of chemotherapy benefit in women aged 50 or under. About 46% of clinically high-risk women could avoid chemotherapy.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT00433589","url":"https://clinicaltrials.gov/study/NCT00433589"},{"label":"MINDACT (NEJM 2016)","url":"https://doi.org/10.1056/NEJMoa1602253"},{"label":"8-year update (Lancet Oncol 2021)","url":"https://doi.org/10.1016/S1470-2045(21)00007-3"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":["rna-seq"],"targets":[],"drugs":["mammaprint"],"companies":["curie-nki-eortc","big"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-piccart-lancet-oncol","paper-cardoso-n-engl-j-med","paper-mindact-ann-oncol-2014"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00433589","phase":"3","setting":"Early breast cancer with discordant clinical and genomic (MammaPrint) risk: chemotherapy or not according to genomic risk","sponsor":"EORTC / Breast International Group","result":"5-year distant metastasis-free survival 94.7% without chemotherapy in clinical-high, genomic-low risk women.","started":"2007-02","yearReported":2016,"enrolled":6693,"enrolledBasis":"registry","outcomes":[{"endpoint":"5-year distant metastasis-free survival, clinical-high / genomic-low risk, no chemotherapy","primary":true,"unit":"%","arms":[{"name":"No chemotherapy (genomic risk)","value":94.7}],"source":"https://doi.org/10.1056/NEJMoa1602253"}],"replication":"TAILORx and RxPONDER reached parallel conclusions with the 21-gene Oncotype DX assay."},{"id":"minnesota-fob","kind":"trial","name":"Minnesota Colon Cancer Control Study","aka":["Minnesota faecal occult blood trial"],"tldr":"The first randomised proof that a yearly stool test for hidden blood saves lives from bowel cancer, by a third over thirteen years.","summary":"The Minnesota Colon Cancer Control Study randomised 46,551 volunteers aged 50 to 80 to annual screening, biennial screening or a control group, using rehydrated Haemoccult slides. At thirteen years cumulative colorectal cancer mortality per 1,000 was 5.88 with annual screening (95% CI 4.61 to 7.15), 8.33 with biennial screening (6.82 to 9.84) and 8.83 in controls (7.26 to 10.40); only the annual group was significantly better, a 33 percent reduction. The benefit came with a shift to earlier stage at diagnosis and better survival among those who developed cancer. Rehydration made the test far more sensitive and far less specific, so 38 percent of the annual group ended up having a colonoscopy, which is part of why later programmes moved to the faecal immunochemical test.","status":"positive","asOf":"2026-09-24","links":[{"label":"Minnesota: reducing mortality from colorectal cancer by screening for fecal occult blood (New England Journal of Medicine 1993)","url":"https://doi.org/10.1056/NEJM199305133281901"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":["early-detection","prevention"],"technologies":["colorectal-screening"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["fit-test"],"trials":["funen-fob","nottingham-fob","nordicc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Volunteers aged 50 to 80: annual or biennial rehydrated Haemoccult faecal occult blood testing against usual care","sponsor":"University of Minnesota","result":"Thirteen-year colorectal cancer mortality 5.88 per 1,000 with annual screening against 8.83 in controls, a 33 percent reduction.","yearReported":1993,"enrolled":46551,"enrolledBasis":"randomised","enrolledNote":"46,551 volunteers were randomised from 1975; the trial predates the registries.","outcomes":[{"endpoint":"Cumulative colorectal cancer mortality at 13 years","primary":true,"unit":"deaths per 1,000","arms":[{"name":"Annual screening","value":5.88},{"name":"Biennial screening","value":8.33},{"name":"Control","value":8.83}],"source":"https://doi.org/10.1056/NEJM199305133281901"}],"replication":"Nottingham and Funen found the same direction with unrehydrated, biennial testing and smaller effects (15 and 18 percent)."},{"id":"mirasol","kind":"trial","name":"MIRASOL / GOG-3045","aka":[],"tldr":"The first ADC to extend life in ovarian cancer, for the roughly one-third of tumours with high folate receptor alpha.","summary":"MIRASOL, also GOG-3045, trial NCT04209855 sponsored by ImmunoGen, now AbbVie, and published in the New England Journal of Medicine in 2023, produced the first antibody-drug conjugate to extend life in ovarian cancer, for the roughly one-third of platinum-resistant tumours with high folate receptor alpha expression. It randomised 453 women with one to three prior lines to mirvetuximab soravtansine or chemotherapy, met its primary progression-free survival endpoint and improved overall survival, leading to full approval in March 2024; ocular toxicity is frequent but reversible with eye-drop prophylaxis. OnCo links it to ovarian cancer, antibody-drug conjugates, folate receptor alpha, mirvetuximab soravtansine, Kathleen N. Moore, Ursula A. Matulonis and the GOG Foundation. Whether the drug can move into platinum-sensitive or maintenance settings is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04209855","url":"https://clinicaltrials.gov/study/NCT04209855"},{"label":"NEJM 2023","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2309169"}],"tags":[],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["adc"],"targets":["folr1"],"drugs":["mirvetuximab-soravtansine"],"companies":["gog-foundation"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["kathleen-moore","ursula-matulonis"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04209855","phase":"3","setting":"Platinum-resistant ovarian cancer with high folate receptor alpha expression, 1-3 prior lines: mirvetuximab soravtansine vs chemotherapy","sponsor":"ImmunoGen (AbbVie)","result":"OS 16.46 vs 12.75 months (HR 0.67).","started":"2019-12-31","startedType":"actual","yearReported":2023,"enrolled":453,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Mirvetuximab","n":227,"value":5.62},{"name":"Chemotherapy","n":226,"value":3.98}],"hr":0.65,"ci":[0.52,0.81],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2309169"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Mirvetuximab","value":16.46},{"name":"Chemotherapy","value":12.75}],"hr":0.67,"ci":[0.5,0.89],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2309169"}]},{"id":"nct06153173","kind":"trial","name":"Mirdametinib in Histiocytic Disorders","aka":[],"tldr":"A phase 2 trial of Mirdametinib in Langerhans cell histiocytosis and Erdheim-Chester disease, Rosai-Dorfman disease and other histiocytic neoplasms, run by Children's Hospital Medical Center, Cincinnati, now recruiting.","summary":"Mirdametinib in Histiocytic Disorders is a phase 2 interventional study registered as NCT06153173 by Children's Hospital Medical Center, Cincinnati, with 40 participants planned, started 2024-02-05 and due to reach its primary completion in 2030-03. Interventions recorded: Mirdametinib. Conditions recorded: Langerhans Cell Histiocytosis (LCH), Juvenile Xanthogranuloma (JXG), Rosai-Dorfman Disease (RDD), Histiocytic Disorders.\n\nLinked to the drug Mirdametinib because the registry names it among its interventions and Langerhans cell histiocytosis and Erdheim-Chester disease, Rosai-Dorfman disease and other histiocytic neoplasms among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06153173","url":"https://clinicaltrials.gov/study/NCT06153173"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["langerhans-cell-histiocytosis","histiocytoses"],"sections":[],"technologies":[],"targets":[],"drugs":["mirdametinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06153173","phase":"2","setting":"A Phase II Trial of the MEK Inhibitor Mirdametinib in Histiocytic Disorders","sponsor":"Children's Hospital Medical Center, Cincinnati","started":"2024-02-05","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07237100","kind":"trial","name":"Mirdametinib in Patients With Advanced NF1-mutant Melanoma","aka":[],"tldr":"A phase 2 trial of Mirdametinib in Advanced melanoma, run by Kevin Kim, MD, now recruiting.","summary":"Mirdametinib in Patients With Advanced NF1-mutant Melanoma is a phase 2 interventional study registered as NCT07237100 by Kevin Kim, MD, with 10 participants planned, started 2025-10-13 and due to reach its primary completion in 2027-10-13. Interventions recorded: Mirdametinib. Conditions recorded: Advanced Unresectable Melanoma, Metastatic Melanoma.\n\nLinked to the drug Mirdametinib because the registry names it among its interventions and Advanced melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07237100","url":"https://clinicaltrials.gov/study/NCT07237100"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["mirdametinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07237100","phase":"2","setting":"A Pilot Study of Mirdametinib in Patients With Advanced Melanoma With an NF1 Mutation","sponsor":"Kevin Kim, MD","started":"2025-10-13","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02990728","kind":"trial","name":"Mirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial Cancer","aka":[],"tldr":"A phase 2 trial of Progestins in Endometrial cancer, run by Chang Gung Memorial Hospital, with a status the registry has not verified recently.","summary":"Mirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial Cancer is a phase 2 interventional study registered as NCT02990728 by Chang Gung Memorial Hospital, with 120 participants planned, started 2016-03 and due to reach its primary completion in 2018-03. Interventions recorded: Metformin, Mirena®. Conditions recorded: Endometrial Cancer.\n\nLinked to the drug Progestins because the registry names it among its interventions and Endometrial cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02990728","url":"https://clinicaltrials.gov/study/NCT02990728"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial"],"sections":[],"technologies":[],"targets":[],"drugs":["megestrol-progestins"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02990728","phase":"2","setting":"Mirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial Cancer","sponsor":"Chang Gung Memorial Hospital","started":"2016-03","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04274426","kind":"trial","name":"Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer","aka":["MIROVA"],"tldr":"A phase 2 trial of Carboplatin, Doxorubicin, Pegylated liposomal doxorubicin, Gemcitabine and Mirvetuximab soravtansine in ovarian cancer, run by AGO Research GmbH, active and no longer recruiting.","summary":"Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer is a phase 2 interventional study registered as NCT04274426 by AGO Research GmbH, with 136 participants enrolled, started 2021-10-13 and due to reach its primary completion in 2025-12-03. Interventions recorded: Carboplatin, Pegylated liposomal doxorubicin (PLD), Gemcitabine, Paclitaxel and Mirvetuximab Soravtansine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04274426","url":"https://clinicaltrials.gov/study/NCT04274426"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["carboplatin","doxorubicin","pegylated-liposomal-doxorubicin","gemcitabine","mirvetuximab-soravtansine"],"companies":["ago-study-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04274426","phase":"2","setting":"A Randomized Phase II Trial of Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer Eligible for Platinum-based Chemotherapy. Supported by: DIAGNOSTIC PROTOCOL for the VENTANA FOLR1 (FOLR1-2.1) CDx Assay Ventana No. RD004881; Protocol Document No. D152967","sponsor":"AGO Research GmbH","started":"2021-10-13","startedType":"actual","enrolled":136,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05456685","kind":"trial","name":"Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ov","aka":[],"tldr":"A phase 2 trial of Mirvetuximab soravtansine, Carboplatin in ovarian cancer, run by AbbVie, active and no longer recruiting.","summary":"Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer is a phase 2 interventional study registered as NCT05456685 by AbbVie, with 125 participants enrolled, started 2022-09-28 and due to reach its primary completion in 2026-11. Interventions recorded: Mirvetuximab soravtansine, Carboplatin. Conditions listed: High Grade Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05456685","url":"https://clinicaltrials.gov/study/NCT05456685"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["mirvetuximab-soravtansine","carboplatin"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05456685","phase":"2","setting":"Multicenter, Open-label, Phase 2 Study of Carboplatin Plus Mirvetuximab Soravtansine Followed by Mirvetuximab Soravtansine Continuation in FRα Positive, Recurrent Platinum-sensitive, High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Following 1 Prior Line of Platinum-based Chemotherapy","sponsor":"AbbVie","started":"2022-09-28","startedType":"actual","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05445778","kind":"trial","name":"Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal C","aka":["GLORIOSA"],"tldr":"A phase 3 trial of Bevacizumab in ovarian cancer, run by AbbVie, active and no longer recruiting.","summary":"Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer is a phase 3 interventional study registered as NCT05445778 by AbbVie, with 520 participants enrolled, started 2023-03-15 and due to reach its primary completion in 2027-04. Interventions recorded: Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab. Conditions listed: Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05445778","url":"https://clinicaltrials.gov/study/NCT05445778"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["bevacizumab"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05445778","phase":"3","setting":"Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab","sponsor":"AbbVie","started":"2023-03-15","startedType":"actual","enrolled":520,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04651634","kind":"trial","name":"MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients","aka":[],"tldr":"A phase 2 trial of MIT-001 plus CCRT in head and neck squamous cell carcinoma, run by MitoImmune Therapeutics, active and no longer recruiting.","summary":"MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients is a phase 2 interventional study registered as NCT04651634 by MitoImmune Therapeutics, with 60 participants enrolled, started 2021-06-21 and due to reach its primary completion in 2025-12-31. Interventions recorded: MIT-001 plus CCRT.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04651634","url":"https://clinicaltrials.gov/study/NCT04651634"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04651634","phase":"2","setting":"A Phase 2, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of MIT-001 in Prevention of Oral Mucositis in Patients Receiving CCRT for Locally Advanced HNSCC","sponsor":"MitoImmune Therapeutics","started":"2021-06-21","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01624090","kind":"trial","name":"Mithramycin for Lung, Esophagus, and Other Chest Cancers","aka":[],"tldr":"A phase 2 trial of Plicamycin in Lung cancer, Oesophageal cancer, Mesothelioma and Breast cancer, run by National Cancer Institute (NCI), recorded as terminated on the registry.","summary":"Mithramycin for Lung, Esophagus, and Other Chest Cancers is a phase 2 interventional study registered as NCT01624090 by National Cancer Institute (NCI), with 16 participants recorded, started 2012-09-06 and due to reach its primary completion in 2019-08-20. Interventions recorded: Mithramycin. Conditions recorded: Lung Cancer, Esophageal Cancer, Mesothelioma, Gastrointestinal Neoplasms, Breast Cancer.\n\nLinked to the drug Plicamycin because the registry names it among its interventions and Lung cancer, Oesophageal cancer, Mesothelioma and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01624090","url":"https://clinicaltrials.gov/study/NCT01624090"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["lung-cancer","esophageal","mesothelioma","breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["plicamycin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01624090","phase":"2","setting":"Phase II Evaluation of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum","sponsor":"National Cancer Institute (NCI)","started":"2012-09-06","startedType":"actual","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07431827","kind":"trial","name":"MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)","aka":["KANDLELIT-013"],"tldr":"A phase 3 trial testing Calderasib in non-small-cell lung cancer, now recruiting.","summary":"MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) is a phase 3 interventional study registered as NCT07431827, led by Merck Sharp & Dohme, and recruiting on the registry. Official title: A Phase 3, Randomised, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Adjuvant Placebo Plus MK-3475A in Participants With Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer Following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013). Planned enrolment is 400 participants (estimated). The study started in 2026-03-18 and primary completion is expected in 2039-10-26. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07431827","url":"https://clinicaltrials.gov/study/NCT07431827"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["calderasib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07431827","phase":"3","setting":"A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Adjuvant Placebo Plus MK-3475A in Participants With Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer Following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)","sponsor":"Merck Sharp & Dohme","started":"2026-03-18","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07723482","kind":"trial","name":"ML-016 in Advanced Cancer With Lung and/or Liver Involvement","aka":[],"tldr":"A phase 1/2 trial in lung cancer, run by BrYet US, Inc., not yet recruiting.","summary":"ML-016 in Advanced Cancer With Lung and/or Liver Involvement is a phase 1/2, interventional study registered as NCT07723482 by BrYet US, Inc., with a registry enrolment figure of 108 participants, started 2026-08 and due to reach its primary completion in 2027-08. Interventions recorded: ML-016. Conditions listed: Advanced Solid Tumor With Lung and/or Liver Involvement. Primary outcome: Incidence of dose-limiting toxicities (DLTs) during the DLT assessment period; Frequency and severity of adverse events (AEs) and serious AEs (SAEs); Maximum tolerated dose (MTD) and doses recommended for expansion. Lung eligibility wording from the registry: \"Evidence of tumor in the lung and/or liver based on imaging studies\". Sites: Australia. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07723482","url":"https://clinicaltrials.gov/study/NCT07723482"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07723482","phase":"1/2","setting":"Phase 1/2 Study of ML-016 in Participants With Advanced Cancer With Lung and/or Liver Involvement","sponsor":"BrYet US, Inc.","started":"2026-08","startedType":"estimated","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05462236","kind":"trial","name":"MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of pembrolizumab and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by AUM Biosciences Pte Ltd, now recruiting.","summary":"MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT05462236 by AUM Biosciences Pte Ltd, with a registry enrolment figure of 120 participants, started 2023-04-14 and due to reach its primary completion in 2024-09-30. Interventions recorded: Tinodasertib; Pembrolizumab; Irinotecan. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Adverse events and Serious Adverse events; Incidence of DLT events and treatment emergent AEs (TEAEs); Objective response rate based on Response Evaluation Criteria in Solid tumors (RECIST) Version 1.1. Colorectal eligibility wording from the registry: \"Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor, and was discontinued from that treatment due to a Grade 3 or higher irAE\". Sites: Australia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05462236","url":"https://clinicaltrials.gov/study/NCT05462236"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["pembrolizumab","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05462236","phase":"2","setting":"A Phase II Open Label, Dose-finding run-in and Cohort Expansion Study to Evaluate the Safety, Tolerability and Effectiveness of Tinodasertib in Combination With Pembrolizumab or Irinotecan in Metastatic Colorectal Cancer","sponsor":"AUM Biosciences Pte Ltd","started":"2023-04-14","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"mntx-302","kind":"trial","name":"MNTX 302","aka":["Study 5","MNTX302"],"tldr":"MNTX 302 showed that a gut-only opioid blocker injected under the skin produced a bowel movement within four hours in about half of people with advanced illness on strong painkillers, against about one in seven on placebo, without weakening pain relief; it was one of the two trials behind the US approval of Relistor.","summary":"MNTX 302 was a randomised, double-blind, placebo-controlled phase 3 trial of subcutaneous methylnaltrexone in adults with advanced illness and opioid-induced constipation who had not responded to stable laxatives. Patients received methylnaltrexone 0.15 mg per kilogram or placebo every other day for two weeks. The coprimary endpoints were laxation within four hours of the first dose and laxation within four hours after two or more of the first four doses.\n\nIn the NEJM 2008 report, 48 percent of patients on methylnaltrexone had laxation within four hours of the first dose versus 15 percent on placebo, and 52 percent versus 8 percent had laxation without a rescue laxative within four hours after two or more of the first four doses (P less than 0.001 for both). Median time to laxation was significantly shorter on methylnaltrexone. Abdominal pain and flatulence were the most common adverse events, and the paper reported no evidence of central opioid withdrawal or change in pain scores.\n\nThe US Relistor label names the same study Study 5 and analyses the same 133 patients (62 Relistor, 71 placebo); across its two advanced-illness studies most patients had a primary diagnosis of incurable cancer. The registry lists organisation id MNTX 302 as a completed phase 3 with an actual enrolment of 134. The programme treats opioid-induced constipation in advanced illness rather than a named cancer, so the record carries no cancer ids.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00402038","url":"https://clinicaltrials.gov/study/NCT00402038"},{"label":"NEJM 2008","url":"https://doi.org/10.1056/NEJMoa0707377"},{"label":"Relistor label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c488fb7c-0a5b-487c-b452-996809d1cb99"}],"tags":[],"related":[],"cancers":[],"sections":["supportive-care"],"technologies":[],"targets":[],"drugs":["methylnaltrexone"],"companies":["bausch-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-mntx-302-thomas-nejm-2008"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00402038","phase":"3","setting":"Advanced illness with opioid-induced constipation despite stable opioids and laxatives: subcutaneous methylnaltrexone 0.15 mg per kilogram every other day for two weeks versus placebo","sponsor":"Bausch Health Americas (originally Progenics and Wyeth)","result":"Laxation within four hours of the first dose 48% vs 15% on placebo; laxation after two or more of the first four doses 52% vs 8% (P<0.001 for both).","started":"2004-02","yearReported":2008,"enrolled":133,"enrolledBasis":"randomised","enrolledNote":"The NEJM 2008 abstract reports 133 patients randomly assigned, and the Relistor label analyses the same 133 (62 methylnaltrexone, 71 placebo) as Study 5; ClinicalTrials.gov NCT00402038 lists an actual enrolment of 134.","outcomes":[{"endpoint":"Laxation within 4 hours of the first dose","primary":true,"unit":"%","arms":[{"name":"Methylnaltrexone 0.15 mg/kg","value":48},{"name":"Placebo","value":15}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa0707377"},{"endpoint":"Laxation without rescue laxative within 4 hours after two or more of the first four doses","primary":true,"unit":"%","arms":[{"name":"Methylnaltrexone 0.15 mg/kg","value":52},{"name":"Placebo","value":8}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa0707377"}],"replication":"The single-dose companion pivotal MNTX 301 (NCT00401362, Slatkin 2009; Relistor label Study 4) reported the same direction of effect and is not yet recorded here."},{"id":"nct00103662","kind":"trial","name":"Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients","aka":[],"tldr":"A phase 3 trial of Plerixafor in Multiple myeloma, run by Genzyme, a Sanofi Company, completed.","summary":"Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients is a phase 3 interventional study registered as NCT00103662 by Genzyme, a Sanofi Company, with 302 participants recorded, started 2005-01 and reaching its primary completion in 2006-10. Interventions recorded: Granulocyte colony-stimulating factor plus plerixafor, Granulocyte colony-stimulating factor plus placebo. Conditions recorded: Multiple Myeloma.\n\nLinked to the drug Plerixafor because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00103662","url":"https://clinicaltrials.gov/study/NCT00103662"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["plerixafor"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00103662","phase":"3","setting":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 6*10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation","sponsor":"Genzyme, a Sanofi Company","started":"2005-01","enrolled":302,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06514508","kind":"trial","name":"Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients","aka":[],"tldr":"A phase 3 trial of Motixafortide, Filgrastim in multiple myeloma, run by Guangzhou Gloria Biosciences Co., Ltd., now recruiting.","summary":"Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients is a phase 3 interventional study registered as NCT06514508 by Guangzhou Gloria Biosciences Co., Ltd., with 60 participants planned, started 2025-12-01 and due to reach its primary completion in 2026-09-11. Interventions recorded: Motixafortide+G-CSF, Placebo+G-CSF. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06514508","url":"https://clinicaltrials.gov/study/NCT06514508"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["motixafortide","filgrastim"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06514508","phase":"3","setting":"A Phase Ⅲ, Randomized, Double-Blinded Study Evaluating the Safety and Efficacy of Combination Treatment of Motixafortide and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma","sponsor":"Guangzhou Gloria Biosciences Co., Ltd.","started":"2025-12-01","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05429632","kind":"trial","name":"Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT","aka":["MO-TRANS"],"tldr":"A phase 3 trial of mocravimod in acute myeloid leukaemia, run by Priothera SAS, now recruiting.","summary":"Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT is a phase 3 interventional study registered as NCT05429632 by Priothera SAS, with 366 participants planned, started 2022-06-16 and due to reach its primary completion in 2027-05. Interventions recorded: mocravimod.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05429632","url":"https://clinicaltrials.gov/study/NCT05429632"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05429632","phase":"3","setting":"Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HCT","sponsor":"Priothera SAS","started":"2022-06-16","startedType":"actual","enrolled":366,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06641635","kind":"trial","name":"Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer","aka":[],"tldr":"A phase 3 trial of Adaptive radiotherapy in Cervical cancer, run by Peking Union Medical College Hospital, now recruiting.","summary":"Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer is a phase 3 interventional study registered as NCT06641635 by Peking Union Medical College Hospital, with 440 participants planned, started 2024-11-19 and due to reach its primary completion in 2026-10-31. Interventions recorded: Moderated hypofractionated online adaptive radiotherapy, Conventional radiotherapy. Conditions recorded: Cervical Cancer, Adaptive Radiotherapy.\n\nLinked to the technology Adaptive radiotherapy because the registry names it (\"adaptive radiotherapy\") among its interventions and Cervical cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06641635","url":"https://clinicaltrials.gov/study/NCT06641635"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cervical"],"sections":[],"technologies":["adaptive-radiotherapy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06641635","phase":"3","setting":"A Multicenter, Non-inferiority, Phase 3, Randomized Controlled Study of Moderated Hypofractionated Online Adaptive Radiotherapy for Cervical Cancer","sponsor":"Peking Union Medical College Hospital","started":"2024-11-19","startedType":"actual","enrolled":440,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05329532","kind":"trial","name":"Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer","aka":["ModiFY"],"tldr":"A phase 1/2 trial of Pembrolizumab in triple-negative breast cancer, renal cell carcinoma, ovarian cancer and head and neck squamous cell carcinoma, run by Scancell Ltd, now recruiting.","summary":"Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer is a phase 1/2 interventional study registered as NCT05329532 by Scancell Ltd, with 168 participants planned, started 2022-04-07 and due to reach its primary completion in 2026-07-01. Interventions recorded: Modi-1 Moditope, Pembrolizumab and MicronJet600™ microneedle device (NanoPass).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05329532","url":"https://clinicaltrials.gov/study/NCT05329532"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","rcc","ovarian","head-and-neck"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["scancell"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05329532","phase":"1/2","setting":"A Phase 1/2, Multicentre, Open-Label Study of Modi-1 Moditope in Patients With Breast, Head and Neck, Ovarian, or Renal Cancer","sponsor":"Scancell Ltd","started":"2022-04-07","startedType":"actual","enrolled":168,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06923345","kind":"trial","name":"Modified Long-Course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for MSS/pMMR High-risk Mid/Low LARC (MODIFI-RC-I)","aka":["MODIFI-RC-I"],"tldr":"A phase 2 trial in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"Modified Long-Course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for MSS/pMMR High-risk Mid/Low LARC (MODIFI-RC-I) is a phase 2, randomised interventional study registered as NCT06923345 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 80 participants, started 2025-03-31 and due to reach its primary completion in 2027-12-31. Interventions recorded: Reduced CTV; Conventional CTV. Conditions listed: Rectal Cancer; Neoadjuvant Therapies; Immune Checkpoint Therapy; Radiotherapy. Primary outcome: Complete response (CR) rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06923345","url":"https://clinicaltrials.gov/study/NCT06923345"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06923345","phase":"2","setting":"Modified Long-Course Radiotherapy (Reduced vs. Conventional CTV), Sequential Chemotherapy and PD-1 Inhibitor in Locally Advanced, MSS, Mid-Low Rectal Cancer: An Open-Label, Two-Arm, Randomized, Prospective Phase II Clinical Trial (MODIFI-RC-I)","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2025-03-31","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05228431","kind":"trial","name":"Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Zhen-Hai Lu, now recruiting.","summary":"Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT05228431 by Zhen-Hai Lu, with a registry enrolment figure of 121 participants, started 2022-03-02 and due to reach its primary completion in 2027-05-01. Interventions recorded: XELOX; Capecitabine monotherapy; Radiation. Conditions listed: Advanced Rectal Cancer. Primary outcome: Rate of pCR. Colorectal eligibility wording from the registry: \"Pathological confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05228431","url":"https://clinicaltrials.gov/study/NCT05228431"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05228431","phase":"2","setting":"Single Arm and Phase II Clinical Trial of a Sandwich Regimen as XELOX Regimen and Capecitabine Alternate Administration Combined With Preoperative Intensity Modulated Radiation Therapy for pMMR Locally Advanced Rectal Cancer","sponsor":"Zhen-Hai Lu","started":"2022-03-02","startedType":"actual","enrolled":121,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06493552","kind":"trial","name":"Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors","aka":[],"tldr":"A phase 2/3 trial of Pembrolizumab, Gemcitabine, Cisplatin and Enfortumab vedotin in bladder & urothelial cancer, run by Vasgene Therapeutics, Inc, now recruiting.","summary":"Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors is a phase 2/3 interventional study registered as NCT06493552 by Vasgene Therapeutics, Inc, with 700 participants planned, started 2025-03-15 and due to reach its primary completion in 2029-09. Interventions recorded: SEphB4-HSA, Pembrolizumab, Gemcitabine, Cisplatin and Enfortumab vedotin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06493552","url":"https://clinicaltrials.gov/study/NCT06493552"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","gemcitabine","cisplatin","enfortumab-vedotin"],"companies":["vasgene-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06493552","phase":"2/3","setting":"A Modular, Open Label, Randomized Phase II/III Trial to Assess Efficacy of Combining sEphB4-HSA (EphrinB2 Inhibitor) With Immunotherapy Regimens in Patients With EphrinB2-High Solid Tumors","sponsor":"Vasgene Therapeutics, Inc","started":"2025-03-15","startedType":"actual","enrolled":700,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07372300","kind":"trial","name":"Modulated Electro-Hyperthermia in Combination With Multimodal Therapy for Locally Advanced Rectal Cancer","aka":["mEHT"],"tldr":"A phase 3 trial in colorectal cancer, run by Shih-Kai Hung, now recruiting.","summary":"Modulated Electro-Hyperthermia in Combination With Multimodal Therapy for Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT07372300 by Shih-Kai Hung, with a registry enrolment figure of 126 participants, started 2025-09-23 and due to reach its primary completion in 2027-12-31. Interventions recorded: Hyperthermia. Conditions listed: Locally Advanced Rectal Carcinoma. Primary outcome: Down-staging Rate. Colorectal eligibility wording from the registry: \"Initial pathological diagnosis of adenocarcinoma of the rectum\". Sites: Taiwan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07372300","url":"https://clinicaltrials.gov/study/NCT07372300"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07372300","phase":"3","setting":"The Efficacy of Combination of Modulated Electro-Hyperthermia(mEHT) in The Multimodality Management in Locally Advanced Rectal Cancer: A Multicenter Phase 3 Randomized Control Trial.","sponsor":"Shih-Kai Hung","started":"2025-09-23","startedType":"actual","enrolled":126,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05462496","kind":"trial","name":"Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of fOLFIRINOX / mFOLFIRINOX and pembrolizumab in pancreatic cancer, run by Icahn School of Medicine at Mount Sinai, now recruiting.","summary":"Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer is a phase 2, interventional study registered as NCT05462496 by Icahn School of Medicine at Mount Sinai, with a registry enrolment figure of 25 participants, started 2023-03-16 and due to reach its primary completion in 2027-08. Interventions recorded: Biopsy; FOLFIRINOX; Ciprofloxacin; Metronidazole; Pembrolizumab; Surgical Resection. Conditions listed: Pancreatic Cancer. Primary outcome: Achievement of overall immune response; Achievement of overall immune response. Pancreatic eligibility wording from the registry: \"* Histologically confirmed pancreatic adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05462496","url":"https://clinicaltrials.gov/study/NCT05462496"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfirinox","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05462496","phase":"2","setting":"Pilot Study of Gut Microbiome Modulation to Enable Efficacy of Neoadjuvant Checkpoint-based Immunotherapy Following Chemotherapy in Pancreatic Adenocarcinoma","sponsor":"Icahn School of Medicine at Mount Sinai","started":"2023-03-16","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"mohs-versus-excision-facial-bcc","kind":"trial","name":"Mohs surgery against ordinary excision for facial basal cell carcinoma (Maastricht trial)","aka":["Maastricht Mohs trial","Mohs versus surgical excision trial","Dutch Mohs trial"],"tldr":"This is the only randomised trial of the microscope-guided skin cancer operation against the ordinary one. For a cancer that has already come back once, the microscope-guided operation clearly wins. For a cancer being treated the first time, the difference took ten years to appear and never reached statistical significance.","summary":"Seven hospitals in the Netherlands randomised 408 high-risk primary and 204 recurrent facial basal cell carcinomas to Mohs micrographic surgery or to ordinary excision between October 1999 and February 2002. For the primary tumours, high risk meant a diameter of at least 1 cm, a location in the H-zone of the face (the H-shaped central band that runs down in front of the ears and across the eyes, nose and lips), or an aggressive histological subtype; the recurrent tumours qualified by having come back. The two groups were randomised separately and are reported separately, which is the point of the trial: the question was not whether Mohs surgery works but in which tumours it is worth its cost.\n\nAt five years the difference in primary tumours was small and not significant: seven recurrences (4.1 per cent) after ordinary excision against four (2.5 per cent) after Mohs surgery, log-rank p=0.397. In recurrent tumours it was significant: ten recurrences (12.1 per cent) after ordinary excision against two (2.4 per cent) after Mohs surgery, p=0.015. Treatment cost 1,248 euros for Mohs surgery against 990 euros for excision in primary tumours and 1,284 against 1,043 euros in recurrent tumours, giving an incremental cost-effectiveness ratio of 23,454 euros for primary and 3,171 euros for recurrent disease. The trial's own conclusion at that point was that ordinary excision is probably enough for most primary tumours.\n\nThe ten-year report changed the shape of the answer without changing its statistics. Cumulative ten-year recurrence was 4.4 per cent after Mohs surgery against 12.2 per cent after excision for primary tumours (log-rank p=0.100) and 3.9 against 13.5 per cent for recurrent tumours (p=0.023). The number that matters most for the reader is this: 56 per cent of the recurrences in primary tumours happened more than five years after treatment, and 14 per cent of those in recurrent tumours. Any five-year trial in this disease, including this one, is reading half the story.","status":"positive","asOf":"2026-09-25","links":[{"label":"ISRCTN65009900","url":"https://www.isrctn.com/ISRCTN65009900"},{"label":"Five-year results (Lancet Oncology 2008)","url":"https://doi.org/10.1016/S1470-2045(08)70260-2"},{"label":"Ten-year results (European Journal of Cancer 2014)","url":"https://doi.org/10.1016/j.ejca.2014.08.018"},{"label":"Ten-year results on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/25262378/"}],"tags":[],"related":[],"cancers":["basal-cell-carcinoma","skin-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["mohs-surgery","surgical-margins-keratinocyte-cancer","resection-margins"],"trials":["sins-trial","avril-surgery-versus-radiotherapy-bcc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN65009900","phase":"3","setting":"High-risk facial basal cell carcinoma, defined as at least 1 cm across, in the central face, or of an aggressive histological subtype, and separately facial basal cell carcinoma that had already recurred: Mohs micrographic surgery against ordinary surgical excision, with recurrence of the carcinoma as the primary outcome. The registry sets the primary analysis at five years; the ten-year report is a long-term extension","sponsor":"Maastricht University Medical Centre, the Netherlands","result":"Ten-year cumulative recurrence 4.4 per cent after Mohs surgery against 12.2 per cent after ordinary excision for primary high-risk facial basal cell carcinoma (p=0.100), and 3.9 against 13.5 per cent for recurrent tumours (p=0.023); 56 per cent of primary-tumour recurrences occurred after year five.","yearReported":2014,"enrolled":612,"enrolledBasis":"randomised","enrolledNote":"408 high-risk primary and 204 recurrent facial basal cell carcinomas were randomised between October 1999 and February 2002; the ISRCTN record gives a target enrolment of 612 and the two tumour groups were randomised and analysed separately.","outcomes":[{"endpoint":"Cumulative recurrence at 10 years, primary facial basal cell carcinoma","primary":true,"unit":"%","arms":[{"name":"Mohs micrographic surgery","value":4.4},{"name":"Ordinary surgical excision","value":12.2}],"p":"0.100","source":"https://doi.org/10.1016/j.ejca.2014.08.018"},{"endpoint":"Cumulative recurrence at 10 years, recurrent facial basal cell carcinoma","primary":true,"unit":"%","arms":[{"name":"Mohs micrographic surgery","value":3.9},{"name":"Ordinary surgical excision","value":13.5}],"p":"0.023","source":"https://doi.org/10.1016/j.ejca.2014.08.018"},{"endpoint":"Recurrence at 5 years, primary facial basal cell carcinoma","unit":"%","arms":[{"name":"Mohs micrographic surgery","value":2.5,"note":"4 of the tumours followed up"},{"name":"Ordinary surgical excision","value":4.1,"note":"7 of the tumours followed up"}],"p":"0.397","source":"https://doi.org/10.1016/s1470-2045(08)70260-2"},{"endpoint":"Recurrence at 5 years, recurrent facial basal cell carcinoma","unit":"%","arms":[{"name":"Mohs micrographic surgery","value":2.4,"note":"2 of the tumours followed up"},{"name":"Ordinary surgical excision","value":12.1,"note":"10 of the tumours followed up"}],"p":"0.015","source":"https://doi.org/10.1016/s1470-2045(08)70260-2"},{"endpoint":"Treatment cost, primary facial basal cell carcinoma","unit":"euros","arms":[{"name":"Mohs micrographic surgery","value":1248,"note":"incremental cost-effectiveness ratio 23,454 euros per recurrence avoided"},{"name":"Ordinary surgical excision","value":990}],"source":"https://doi.org/10.1016/s1470-2045(08)70260-2"}],"replication":"No second randomised trial of Mohs surgery against ordinary excision exists in basal cell carcinoma. Everything else in the field is a single-arm series, which is why the American appropriate use criteria rest on consensus rather than on randomised evidence."},{"id":"nct03784014","kind":"trial","name":"Molecular Profiling of Advanced Soft-tissue Sarcomas","aka":[],"tldr":"A phase 3 trial of Nilotinib, Ceritinib, Capmatinib, Lapatinib, Trametinib, Olaparib, Palbociclib and Glasdegib in Sarcomas, run by Institut National de la Santé Et de la Recherche Médicale, France, completed.","summary":"Molecular Profiling of Advanced Soft-tissue Sarcomas is a phase 3 interventional study registered as NCT03784014 by Institut National de la Santé Et de la Recherche Médicale, France, with 603 participants recorded, started 2019-10-19 and reaching its primary completion in 2023-12-01. Interventions recorded: Nilotinib, Ceritinib, Capmatinib, Lapatinib, Trametinib, Trametinib and Dabrafenib, Olaparib and Durvalumab, Palbociclib, Glasdegib, TAS-120, Next Generation sequencing exome. Conditions recorded: Soft Tissue Sarcoma.\n\nLinked to the drug Ceritinib because the registry names it among its interventions and Sarcomas among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03784014","url":"https://clinicaltrials.gov/study/NCT03784014"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["nilotinib","ceritinib","capmatinib","lapatinib","trametinib","olaparib","palbociclib","glasdegib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03784014","phase":"3","setting":"Molecular Profiling of Advanced Soft-tissue Sarcomas. A Phase III Study","sponsor":"Institut National de la Santé Et de la Recherche Médicale, France","started":"2019-10-19","startedType":"actual","enrolled":603,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07802418","kind":"trial","name":"Molecularly Tailored Therapy in Advanced Pancreatic Cancer","aka":["TAILOR-PANC"],"tldr":"A phase 2 trial in pancreatic cancer, run by Herlev Hospital, not yet recruiting.","summary":"Molecularly Tailored Therapy in Advanced Pancreatic Cancer is a phase 2, randomised interventional study registered as NCT07802418 by Herlev Hospital, with a registry enrolment figure of 1200 participants, started 2026-10 and due to reach its primary completion in 2031-06. Interventions recorded: Arm 1: Molecularly Tailored Therapy; Arms 2: Standard-of-Care Therapy; Arm 3: Standard-of-Care Observational Cohort. Conditions listed: Pancreatic Cancer. Primary outcome: Progression-Free Survival in Randomized Participants. Sites: Denmark. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07802418","url":"https://clinicaltrials.gov/study/NCT07802418"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07802418","phase":"2","setting":"TAILOR-PANC: Molecularly Tailored Therapy Versus Standard Care in Advanced Pancreatic Cancer (DPCG-02)","sponsor":"Herlev Hospital","started":"2026-10","startedType":"estimated","enrolled":1200,"enrolledBasis":"registry","outcomes":[]},{"id":"molemate","kind":"trial","name":"MoleMate UK Trial","aka":["ISRCTN79932379","SIAscopy with primary care scoring algorithm"],"tldr":"The trial that tested whether giving GPs a diagnostic gadget would make their skin cancer referrals better, found that it made them more numerous instead, and is the reason the NHS asks for training and dermoscopy rather than devices in primary care.","summary":"MoleMate randomised 1,297 adults with 1,580 pigmented lesions across fifteen practices in eastern England. The primary outcome was the appropriateness of referral, measured as the proportion of referred lesions that were then biopsied or monitored in secondary care. It did not differ: 56.8 percent (130 of 229) with MoleMate against 64.5 percent (111 of 172) with best practice alone, a difference of minus 8.1 percentage points with a 95 percent confidence interval of minus 18.0 to 1.8.\n\nWhat did differ was volume and agreement. A higher proportion of lesions was referred with the device, 29.8 percent against 22.4 percent, and agreement with an expert assessment that the lesion was benign was significantly lower, 84.4 percent against 90.6 percent. Thirty-six histologically confirmed melanomas were diagnosed and the 18 in the intervention arm were all appropriately referred. The lesson the NHS took is visible in current policy: no guideline asks a GP to perform dermoscopy, and NG12 recommendation 1.7.2 uses it only as a referral trigger (\"Refer people using a suspected cancer pathway referral if dermoscopy suggests melanoma of the skin\"), while the one place a guideline does ask for the examination itself is QS130 statement 3, at specialist assessment. The timed pathway asks cancer alliances to train primary care in dermoscopy rather than to buy devices, and the device question has moved to artificial intelligence applied to images taken after referral rather than to a gadget in the consulting room.","status":"negative","asOf":"2026-09-25","links":[{"label":"BMJ 2012 (DOI)","url":"https://doi.org/10.1136/bmj.e4110"},{"label":"ISRCTN79932379","url":"https://www.isrctn.com/ISRCTN79932379"}],"tags":["uk","skin","early-detection","primary-care"],"related":[],"cancers":["melanoma","skin-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN79932379","phase":"3","setting":"Fifteen general practices in eastern England: adults with a pigmented skin lesion not immediately diagnosed as benign, assessed by trained primary care clinicians using best practice (history, naked-eye examination and the weighted 7-point checklist) either alone or with the MoleMate system added","sponsor":"University of Cambridge and Cambridgeshire NHS Primary Care Trust, funded by the NIHR","result":"No difference in the appropriateness of referral (56.8 percent against 64.5 percent) and more lesions referred with the device (29.8 percent against 22.4 percent) (BMJ 2012).","yearReported":2012,"enrolled":1297,"enrolledBasis":"analysed","enrolledNote":"The ISRCTN record gives a target of 1,800; 1,297 adults with 1,580 pigmented lesions were randomised and analysed.","outcomes":[]},{"id":"momentum","kind":"trial","name":"MOMENTUM","aka":[],"tldr":"MOMENTUM showed that momelotinib, a JAK inhibitor that also eases anaemia, relieved symptoms and shrank spleens better than danazol in people with myelofibrosis who were anaemic after earlier JAK inhibitor treatment.","summary":"Anaemia is the weak point of the first JAK inhibitors: ruxolitinib and fedratinib worsen it. Momelotinib inhibits JAK1, JAK2 and ACVR1, the last of which lowers hepcidin and improves red cell production. MOMENTUM randomised 195 patients with symptomatic myelofibrosis, anaemia and prior JAK inhibitor treatment to momelotinib or to danazol, an androgen used for anaemia in this disease. The primary endpoint was the proportion with a 50 percent or greater reduction in total symptom score at week 24.\n\nMomelotinib met the primary endpoint and also improved transfusion independence and spleen volume response compared with danazol. It was approved in the United States in September 2023 for myelofibrosis with anaemia, the first JAK inhibitor labelled for that group.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04173494","url":"https://clinicaltrials.gov/study/NCT04173494"}],"tags":["subtype-trials"],"related":[],"cancers":["primary-myelofibrosis","myeloproliferative-neoplasms"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["momelotinib","danazol"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["srdan-verstovsek"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04173494","phase":"3","setting":"Symptomatic, anaemic myelofibrosis previously treated with a JAK inhibitor: momelotinib against danazol","sponsor":"Sierra Oncology (GSK)","result":"Momelotinib improved symptom response, transfusion independence and spleen response compared with danazol; approved in September 2023.","started":"2020-02-07","startedType":"actual","yearReported":2023,"enrolled":195,"enrolledBasis":"registry","outcomes":[{"endpoint":"Total symptom score response (>=50% reduction) at week 24","primary":true,"unit":"%","arms":[{"name":"Momelotinib 200 mg","n":130,"value":25,"note":"Difference 16% (95% CI 6 to 26)"},{"name":"Danazol 300 mg twice daily","n":65,"value":9}],"p":"0.0095","source":"https://doi.org/10.1016/s0140-6736(22)02036-0"},{"endpoint":"Grade 3 or higher anaemia (laboratory)","unit":"%","arms":[{"name":"Momelotinib 200 mg","n":130,"value":61},{"name":"Danazol 300 mg twice daily","n":65,"value":75}],"source":"https://doi.org/10.1016/s0140-6736(22)02036-0"},{"endpoint":"Grade 3 or higher thrombocytopenia (laboratory)","unit":"%","arms":[{"name":"Momelotinib 200 mg","n":130,"value":28},{"name":"Danazol 300 mg twice daily","n":65,"value":26}],"source":"https://doi.org/10.1016/s0140-6736(22)02036-0"}]},{"id":"monaleesa-2","kind":"trial","name":"MONALEESA-2","aka":[],"tldr":"The first CDK4/6 inhibitor trial to show that adding the pill to hormone therapy makes women live longer, by about a year.","summary":"PFS 25.3 vs 16.0 months (HR 0.57); final OS 63.9 vs 51.4 months (HR 0.76, P=0.004), the first OS benefit for a CDK4/6 inhibitor in first-line postmenopausal disease and the longest median OS reported in this setting at the time. With MONALEESA-3 and -7 it established ribociclib as the CDK4/6 inhibitor with the most consistent survival data.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01958021","url":"https://clinicaltrials.gov/study/NCT01958021"}],"tags":[],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":["cdk4-6","estrogen-receptor"],"drugs":["ribociclib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["gabriel-hortobagyi"],"bottlenecks":[],"keyPapers":["paper-monaleesa-2-n-engl-j-med-2016","paper-monaleesa-2-n-engl-j-med-2022-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01958021","phase":"3","setting":"First-line postmenopausal HR+/HER2- advanced breast cancer: ribociclib + letrozole vs placebo + letrozole","sponsor":"Novartis","result":"OS 63.9 vs 51.4 months, HR 0.76.","started":"2013-12-17","startedType":"actual","yearReported":2016,"enrolled":668,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Ribociclib + letrozole","n":334,"value":25.3},{"name":"Placebo + letrozole","n":334,"value":16}],"hr":0.57,"ci":[0.46,0.7],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1609709"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Ribociclib + letrozole","n":334,"value":63.9},{"name":"Placebo + letrozole","n":334,"value":51.4}],"hr":0.76,"ci":[0.63,0.93],"p":"0.004","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2114663"}],"replication":"OS benefit replicated in MONALEESA-7 (premenopausal) and MONALEESA-3 (fulvestrant partner); the class effect on OS was not seen with palbociclib (PALOMA-2)."},{"id":"nct05903092","kind":"trial","name":"MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer","aka":["MOZART"],"tldr":"A phase 2 trial of durvalumab, monalizumab and etoposide in lung cancer, run by Hirva Mamdani, now recruiting.","summary":"MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer is a phase 2, interventional study registered as NCT05903092 by Hirva Mamdani, with a registry enrolment figure of 84 participants, started 2023-09-26 and due to reach its primary completion in 2029-10-31. Interventions recorded: Durvalumab; Monalizumab; Carboplatin or Cisplatin; Etoposide. Conditions listed: Small Cell Lung Cancer; SCLC; Extensive Stage Small Cell Lung Cancer; Limited Stage Small-Cell Lung Cancer. Primary outcome: 1 year Progression Free Survival (PFS); Safety and Tolerability. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed diagnosis of small cell lung cancer:\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05903092","url":"https://clinicaltrials.gov/study/NCT05903092"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["limited-stage-sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["durvalumab","monalizumab","etoposide"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05903092","phase":"2","setting":"A Phase II Trial of MOnaliZumab in Combination With durvAlumab (MEDI4736) for tReatmenT of Small Cell Lung Cancer (MOZART)","sponsor":"Hirva Mamdani","started":"2023-09-26","startedType":"actual","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"monarch-3","kind":"trial","name":"MONARCH 3","aka":[],"tldr":"Abemaciclib roughly doubled the time to progression when added to an aromatase inhibitor; the survival gain of about 13 months narrowly missed statistical significance.","summary":"MONARCH 3, trial NCT02246621 sponsored by Eli Lilly and reported in 2017, showed that abemaciclib roughly doubled the time to progression when added to a non-steroidal aromatase inhibitor as first-line treatment for postmenopausal HR-positive, HER2-negative advanced breast cancer. It randomised 493 women and met its primary progression-free survival endpoint, and the final overall survival analysis showed a numerical gain of about thirteen months that narrowly missed statistical significance at the prespecified threshold. OnCo links it to CDK4/6 as a target, abemaciclib, aromatase inhibitors, Matthew P. Goetz and the bottleneck of wrong doses, and MONARCH 2, which tested abemaciclib with fulvestrant after endocrine progression, did show a significant survival benefit. Whether a large numerical survival gain that misses significance should count is the question the trial leaves open.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02246621","url":"https://clinicaltrials.gov/study/NCT02246621"}],"tags":[],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":["cdk4-6"],"drugs":["abemaciclib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["matthew-goetz"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02246621","phase":"3","setting":"First-line postmenopausal HR+/HER2- advanced breast cancer: abemaciclib + NSAI vs placebo + NSAI","sponsor":"Eli Lilly","result":"PFS HR 0.54; OS 66.8 vs 53.7 months, HR 0.80 (NS).","started":"2014-11-06","startedType":"actual","yearReported":2017,"enrolled":493,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Abemaciclib + NSAI","n":328,"value":28.2},{"name":"Placebo + NSAI","n":165,"value":14.8}],"hr":0.54,"ci":[0.42,0.7],"source":"https://ascopubs.org/doi/10.1200/JCO.2017.75.6155"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Abemaciclib + NSAI","value":66.8},{"name":"Placebo + NSAI","value":53.7}],"hr":0.8,"ci":[0.62,1.03],"p":"0.066","source":"https://doi.org/10.1200/JCO.2017.75.6155"}],"replication":"MONARCH 2 (abemaciclib + fulvestrant after endocrine progression) did show a significant OS benefit (HR 0.76)."},{"id":"monarche","kind":"trial","name":"monarchE","aka":[],"tldr":"The first CDK4/6 inhibitor to reduce recurrence after surgery in high-risk hormone-positive breast cancer.","summary":"monarchE, trial NCT03155997 sponsored by Eli Lilly and reported in 2020, produced the first CDK4/6 inhibitor to reduce recurrence after surgery in high-risk, node-positive HR-positive, HER2-negative early breast cancer. It randomised 5,637 patients to two years of abemaciclib plus endocrine therapy or endocrine therapy alone, met its primary invasive disease-free survival endpoint at two years with the benefit widening at five years in a carry-over effect, and improved distant relapse-free survival, with overall survival trending favourably but not yet significant. OnCo links it to HR-positive breast cancer, abemaciclib, Stephen Johnston, Nadia Harbeck, Miguel Martín, the lymph node status term, the idea of using residual disease tests to decide who needs ten years of hormone therapy and the monarchE and NATALEE papers. Whether the benefit becomes a survival benefit is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT03155997","url":"https://clinicaltrials.gov/study/NCT03155997"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["abemaciclib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["stephen-johnston","nadia-harbeck","miguel-martin"],"bottlenecks":[],"keyPapers":["paper-monarche-lancet-oncol-2023","paper-monarche-ann-oncol-2026-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03155997","phase":"3","setting":"Adjuvant abemaciclib 2 years + endocrine therapy in high-risk node-positive HR+/HER2- breast cancer","sponsor":"Eli Lilly","result":"iDFS HR 0.68.","started":"2017-07-12","startedType":"actual","yearReported":2020,"enrolled":5637,"enrolledBasis":"registry","outcomes":[{"endpoint":"Invasive disease-free survival at 2 years","primary":true,"unit":"%","arms":[{"name":"Abemaciclib + endocrine therapy","n":2808,"value":92.2},{"name":"Endocrine therapy alone","n":2829,"value":88.7}],"hr":0.75,"ci":[0.6,0.93],"p":"0.01","source":"https://ascopubs.org/doi/10.1200/JCO.20.02514"},{"endpoint":"Invasive disease-free survival at 5 years","unit":"%","arms":[{"name":"Abemaciclib + endocrine therapy","value":83.6},{"name":"Endocrine therapy alone","value":76}],"hr":0.68,"ci":[0.6,0.77],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00525-2/fulltext"},{"endpoint":"Distant relapse-free survival at 5 years","unit":"%","arms":[{"name":"Abemaciclib + endocrine therapy","value":86},{"name":"Endocrine therapy alone","value":79.2}],"hr":0.675,"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00525-2/fulltext"}],"replication":"Confirmed by NATALEE (ribociclib) for the CDK4/6 adjuvant concept in high-risk disease; the benefit widened over time (carry-over effect)."},{"id":"monumental-1","kind":"trial","name":"MonumenTAL-1","aka":[],"tldr":"Showed that a second target, GPRC5D, works in myeloma, including after BCMA therapies have failed.","summary":"MonumenTAL-1, trial NCT04634552 sponsored by Janssen and reported in 2022, showed that a second target, GPRC5D, works in myeloma, including after BCMA-directed therapies have failed. In 288 patients after at least three prior lines the bispecific talquetamab produced responses in about 74 percent at weekly dosing and 72 percent at fortnightly dosing, and in 65 percent of those who had received prior T-cell redirection, while taste, skin and nail toxicities were frequent. OnCo links it to multiple myeloma, talquetamab, Ajai Chari and the pairing of BCMA-directed therapy followed by GPRC5D-directed therapy. Whether the distinctive toxicities can be managed for long-term use is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04634552","url":"https://clinicaltrials.gov/study/NCT04634552"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["talquetamab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ajai-chari"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04634552","phase":"1/2","setting":"Relapsed/refractory myeloma after ≥3 lines: talquetamab (weekly or biweekly)","sponsor":"Janssen","result":"ORR ~73%.","started":"2021-02-01","startedType":"actual","yearReported":2022,"enrolled":288,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Talquetamab 0.8 mg/kg Q2W","n":145,"value":71.7},{"name":"Talquetamab 0.4 mg/kg QW","n":143,"value":74.1}],"source":"https://doi.org/10.1056/NEJMoa2204591"}]},{"id":"morpho","kind":"trial","name":"MORPHO","aka":["BMT CTN 1506","2215-CL-0304"],"tldr":"MORPHO asked whether taking the FLT3 blocker gilteritinib for two years after a stem-cell transplant keeps leukaemia from returning; across everyone the benefit fell just short of statistical proof, but in the half of patients whose blood tests still showed traces of leukaemia the drug clearly cut relapses.","summary":"MORPHO (BMT CTN 1506) was a double-blind, placebo-controlled phase 3 trial run by Astellas with the Blood and Marrow Transplant Clinical Trials Network. Adults with FLT3-ITD acute myeloid leukaemia in first remission who had undergone allogeneic transplant were randomised to gilteritinib or placebo for 24 months. The primary endpoint was relapse-free survival; measurable residual disease (MRD) for FLT3-ITD was assessed before and after transplant with a highly sensitive assay.\n\nRelapse-free survival favoured gilteritinib but the difference was not statistically significant (hazard ratio 0.679, two-sided p 0.0518). About half of participants had detectable MRD before or after transplant, and in that prespecified subgroup gilteritinib halved the hazard of relapse or death, while patients without detectable MRD gained nothing. The trial is one of the first to support choosing post-transplant therapy by MRD, and the standard-of-care text for acute myeloid leukaemia describes FLT3 inhibitor maintenance after transplant for MRD-positive disease on this evidence.","status":"mixed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02997202","url":"https://clinicaltrials.gov/study/NCT02997202"}],"tags":["soc-trials"],"related":[],"cancers":["aml-flt3","aml","leukaemia"],"sections":[],"technologies":["kinase-inhibitors","allogeneic-hsct","mrd-testing"],"targets":[],"drugs":["gilteritinib"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-morpho-gilteritinib-levis-jco-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02997202","phase":"3","setting":"FLT3-ITD acute myeloid leukaemia in first remission after allogeneic transplant: gilteritinib 120 mg or placebo daily for 24 months as post-transplant maintenance, with measurable residual disease measured before and after transplant","sponsor":"Astellas Pharma Global Development, Inc.","result":"Relapse-free survival hazard ratio 0.679 for gilteritinib against placebo, not statistically significant overall; in the prespecified MRD-positive half of patients the hazard ratio was 0.515, with no benefit in MRD-negative patients.","started":"2017-08-16","startedType":"actual","yearReported":2024,"enrolled":356,"enrolledBasis":"registry","outcomes":[{"endpoint":"Relapse-free survival","primary":true,"arms":[{"name":"Gilteritinib maintenance","note":"Median not reached in either arm; 356 randomised"},{"name":"Placebo"}],"hr":0.679,"ci":[0.459,1.005],"p":"0.0518","source":"https://doi.org/10.1200/jco.23.02474"},{"endpoint":"Relapse-free survival, MRD detectable before or after transplant (prespecified subgroup, 50.5% of participants)","arms":[{"name":"Gilteritinib maintenance"},{"name":"Placebo"}],"hr":0.515,"ci":[0.316,0.838],"p":"0.0065","source":"https://doi.org/10.1200/jco.23.02474"},{"endpoint":"Relapse-free survival, MRD not detectable","arms":[{"name":"Gilteritinib maintenance"},{"name":"Placebo"}],"hr":1.213,"ci":[0.616,2.387],"p":"0.575","source":"https://doi.org/10.1200/jco.23.02474"}]},{"id":"mosaic","kind":"trial","name":"MOSAIC","aka":["Multicenter International Study of Oxaliplatin/5-FU-LV in the Adjuvant Treatment of Colon Cancer"],"tldr":"The trial that put oxaliplatin into chemotherapy after bowel cancer surgery. It cut recurrences by a fifth and, in stage III disease, lengthened life.","summary":"MOSAIC randomised 2,246 patients who had undergone curative resection for stage II or III colon cancer to six months of fluorouracil and leucovorin with or without oxaliplatin. Disease-free survival at three years was 78.2 against 72.9 percent (hazard ratio 0.77, p=0.002). At six years overall survival was 78.5 against 76.0 percent (hazard ratio 0.84, p=0.046); the gain was confined to stage III disease (72.9 against 68.7 percent, hazard ratio 0.80, p=0.023) with no difference in stage II. Grade 3 sensory neuropathy affected 12.4 percent during treatment and 1.1 percent at one year, and this cumulative neurotoxicity is what the IDEA duration question later tried to avoid. MOSAIC is the reason adjuvant FOLFOX or CAPOX is offered for stage III colon cancer and the reason stage II disease is treated only when risk factors are present.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00275210","url":"https://clinicaltrials.gov/study/NCT00275210"},{"label":"MOSAIC: oxaliplatin, fluorouracil and leucovorin as adjuvant treatment for colon cancer (New England Journal of Medicine 2004)","url":"https://doi.org/10.1056/NEJMoa032709"},{"label":"MOSAIC six-year overall survival (Journal of Clinical Oncology 2009)","url":"https://doi.org/10.1200/JCO.2008.20.6771"}],"tags":[],"related":[],"cancers":["colorectal","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","oxaliplatin","fluorouracil","leucovorin"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00275210","phase":"3","setting":"Stage II or III colon cancer after curative resection: FOLFOX4 for six months against fluorouracil and leucovorin alone","sponsor":"Sanofi","result":"Three-year disease-free survival 78.2 against 72.9 percent (hazard ratio 0.77); six-year overall survival benefit in stage III only.","started":"1998-10","yearReported":2004,"enrolled":2246,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 3 years","primary":true,"unit":"percent","arms":[{"name":"FOLFOX4","n":1123,"value":78.2},{"name":"Fluorouracil and leucovorin","n":1123,"value":72.9}],"hr":0.77,"p":"0.002","source":"https://doi.org/10.1056/NEJMoa032709"},{"endpoint":"Overall survival at 6 years (stage III)","unit":"percent","arms":[{"name":"FOLFOX4","value":72.9},{"name":"Fluorouracil and leucovorin","value":68.7}],"hr":0.8,"p":"0.023","source":"https://doi.org/10.1200/JCO.2008.20.6771"}],"replication":"Confirmed by NSABP C-07 and, for capecitabine plus oxaliplatin, by NO16968/XELOXA; the duration was later shortened for low-risk disease by the IDEA collaboration."},{"id":"mosun-lbt-fl","kind":"trial","name":"Mosunetuzumab against rituximab in low tumour burden follicular lymphoma","aka":["Rituximab versus mosunetuzumab in low tumour burden follicular lymphoma"],"tldr":"A large American trial testing whether a two-headed antibody that recruits the immune system should replace the standard antibody as the first treatment for slow-growing follicular lymphoma.","summary":"Low tumour burden follicular lymphoma is the setting in which rituximab alone, given as four weekly doses, has been the gentle standard for twenty years, and in which watch and wait remains a reasonable alternative. This National Cancer Institute trial asks whether mosunetuzumab, a CD20 by CD3 bispecific antibody given for a fixed duration, does better.\n\nIt is among the first phase 3 trials to put a bispecific antibody against rituximab in a first-line, low-burden population; the class has so far been tested almost entirely in relapsed disease. Participants are randomised between rituximab (with the hyaluronidase subcutaneous formulation permitted) and mosunetuzumab. The co-primary endpoints are three-year progression-free survival and progression-free survival overall, with primary completion estimated for 31 March 2032.\n\nWhat makes it worth watching is the question underneath it: whether a treatment that produces deep remissions in heavily pretreated disease changes the natural history when it is given first, or simply moves the same remission earlier. The answer bears on every indolent lymphoma.","status":"active","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT06337318","url":"https://clinicaltrials.gov/study/NCT06337318"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["follicular-lymphoma","non-hodgkin-lymphoma"],"sections":["immunotherapy"],"technologies":["bispecific-antibody","t-cell-engager","monoclonal-antibody"],"targets":["cd20","cd3"],"drugs":["mosunetuzumab","rituximab"],"companies":[],"institutions":["nci"],"pathways":[],"terms":["flipi","watchful-waiting","lymphoma-tx-watch-and-wait"],"trials":[],"people":[],"bottlenecks":["b-trial-design","b-drug-pricing"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06337318","phase":"3","setting":"Follicular lymphoma with a low tumour burden needing first treatment: four weekly doses of rituximab against fixed-duration mosunetuzumab","sponsor":"National Cancer Institute","started":"2024-10-23","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"mosun-len-mzl","kind":"trial","name":"Mosunetuzumab with lenalidomide in relapsed marginal zone lymphoma","aka":["Mosunetuzumab-lenalidomide in marginal zone lymphoma"],"tldr":"A European trial for a lymphoma that rarely gets its own study, testing a two-headed antibody with a tablet against the three combinations doctors currently choose between.","summary":"Marginal zone lymphoma is usually studied as a minority arm inside follicular lymphoma trials, which is why so little of its treatment rests on randomised evidence. This trial is run exclusively in it, across Belgium, France, Germany, Italy and Portugal, and takes all three marginal zone subtypes: extranodal, splenic and nodal.\n\nParticipants have had at least one and no more than three prior systemic lines, including at least two cycles of a CD20-directed antibody with or without chemotherapy, or a targeted treatment such as ibrutinib. They are randomised between subcutaneous mosunetuzumab with lenalidomide 20 mg daily on days 1 to 21 of cycles 2 to 6, and an investigator's choice declared before randomisation of rituximab with lenalidomide, rituximab with bendamustine, or R-CHOP. Randomisation is stratified by marginal zone subtype and by whether progression after first-line treatment occurred within two years.\n\nThe primary endpoint is investigator-assessed progression-free survival by the Lugano 2014 criteria, with primary completion estimated for September 2027. Stratifying by early progression is the design detail that matters: it is the first time a marginal zone trial has treated the two-year progression marker as a planned subgroup rather than an afterthought.","status":"active","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT06006117","url":"https://clinicaltrials.gov/study/NCT06006117"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["marginal-zone-lymphoma","malt-lymphoma","splenic-marginal-zone-lymphoma","nodal-marginal-zone-lymphoma","non-hodgkin-lymphoma"],"sections":["immunotherapy"],"technologies":["bispecific-antibody","t-cell-engager"],"targets":["cd20","cd3"],"drugs":["mosunetuzumab","lenalidomide","rituximab","bendamustine","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":["lysa"],"institutions":[],"pathways":[],"terms":["lugano-classification","lymphoma-tx-pod24","r-chop"],"trials":[],"people":[],"bottlenecks":["b-rare-cancers","b-trial-enrolment"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06006117","phase":"3","setting":"Relapsed or refractory marginal zone lymphoma after one to three prior lines: mosunetuzumab with lenalidomide against the investigator's choice of rituximab with lenalidomide, bendamustine or CHOP","sponsor":"The Lymphoma Academic Research Organisation","started":"2023-09-05","startedType":"actual","enrolled":260,"enrolledBasis":"registry","outcomes":[]},{"id":"motion","kind":"trial","name":"MOTION","aka":[],"tldr":"MOTION randomised 123 patients with symptomatic tenosynovial giant cell tumour not suitable for surgery to the CSF1R inhibitor vimseltinib or placebo. Tumours shrank in 40% on vimseltinib versus none on placebo, with better joint movement, pain and function, leading to approval in February 2025; whether responses last after stopping is unknown.","summary":"MOTION, trial NCT05059262 sponsored by Deciphera and published in the Lancet in 2024, showed that the CSF1R inhibitor vimseltinib shrank tenosynovial giant cell tumours in forty percent of patients versus none on placebo, with better joint function. It randomised 123 patients with symptomatic disease not amenable to surgery, met its primary objective response endpoint at week 25 and improved active range of motion, pain, stiffness and function, leading to approval in February 2025. OnCo links it to sarcomas and tenosynovial giant cell tumour and to vimseltinib. Whether long-term treatment is needed or responses persist after stopping is the open question for a benign but disabling tumour.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05059262","url":"https://clinicaltrials.gov/study/NCT05059262"}],"tags":[],"related":[],"cancers":["sarcoma","tenosynovial-giant-cell-tumour"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["vimseltinib"],"companies":["deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05059262","phase":"3","setting":"Symptomatic tenosynovial giant cell tumour not amenable to surgery: vimseltinib vs placebo","sponsor":"Deciphera","result":"ORR 40% vs 0%.","started":"2021-10-14","startedType":"actual","yearReported":2024,"enrolled":123,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate at week 25","primary":true,"unit":"%","arms":[{"name":"Vimseltinib","n":83,"value":40},{"name":"Placebo","n":40,"value":0}],"p":"<0.0001","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00885-7/fulltext"}]},{"id":"mountaineer","kind":"trial","name":"MOUNTAINEER","aka":[],"tldr":"A HER2 pill plus antibody gave durable responses in the 3-5% of bowel cancers driven by HER2, and is now being tested as first-line treatment.","summary":"MOUNTAINEER phase 2: confirmed ORR 38.1%, median duration of response 12.4 months; FDA accelerated approval January 2023 (first HER2-directed regimen in CRC). The randomised phase 3 successor is a separate record, MOUNTAINEER-03 (NCT05253651, 400 patients, primary completion December 2027).","status":"completed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03043313","url":"https://clinicaltrials.gov/study/NCT03043313"},{"label":"MOUNTAINEER-03 NCT05253651","url":"https://clinicaltrials.gov/study/NCT05253651"},{"label":"MOUNTAINEER: tucatinib plus trastuzumab for chemotherapy-refractory HER2-positive RAS wild-type metastatic colorectal cancer (Lancet Oncology 2023)","url":"https://doi.org/10.1016/S1470-2045(23)00150-X"}],"tags":[],"related":[],"cancers":["colorectal","her2-amplified-colorectal"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","kinase-inhibitors"],"targets":["her2"],"drugs":["tucatinib","trastuzumab","folfox","bevacizumab","cetuximab","oxaliplatin"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":["mountaineer-03","destiny-crc01"],"people":["tanios-bekaii-saab"],"bottlenecks":[],"keyPapers":["paper-valtorta-her2-scoring-colorectal-heracles-mod-pathol-2015","paper-richman-her2-amplification-quasar-focus-piccolo-j-pathol-2016","paper-strickler-mountaineer-tucatinib-trastuzumab-lancet-oncol-2023","paper-mountaineer-nat-commun-2026-update"],"journals":[],"dependsOn":[],"notes":["The randomised phase 3 successor is a separate record, `mountaineer-03` (NCT05253651), which is recruiting with primary completion due 31 December 2027."],"nct":"NCT03043313","phase":"2","setting":"Chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic colorectal cancer: tucatinib plus trastuzumab (cohorts A and B) or tucatinib alone (cohort C)","sponsor":"Pfizer (Seagen)","result":"Phase 2 ORR 38.1%, DOR 12.4 months; phase 3 ongoing.","started":"2017-06-23","startedType":"actual","yearReported":2022,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (phase 2)","primary":true,"unit":"percent","arms":[{"name":"Tucatinib + trastuzumab","n":84,"value":38.1}],"source":"https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3509"}]},{"id":"mountaineer-03","kind":"trial","name":"MOUNTAINEER-03","aka":[],"tldr":"The trial that will decide whether HER2 drugs belong in the first treatment for HER2-positive bowel cancer rather than after chemotherapy has failed.","summary":"MOUNTAINEER-03 is the randomised phase 3 successor to the single-arm MOUNTAINEER cohorts that won tucatinib plus trastuzumab its accelerated approval on 19 January 2023. It randomises about 400 patients with previously untreated HER2-positive, RAS wild-type metastatic colorectal cancer to tucatinib and trastuzumab with mFOLFOX6, or to mFOLFOX6 with bevacizumab or cetuximab at the investigator's choice. The registry records a start date of 24 October 2022, recruitment continuing and primary completion due 31 December 2027, so the confirmatory evidence for the accelerated approval is several years away. Until then HER2-directed treatment in colorectal cancer is a later-line option and HER2 testing is not yet required at diagnosis everywhere.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05253651","url":"https://clinicaltrials.gov/study/NCT05253651"},{"label":"MOUNTAINEER: tucatinib plus trastuzumab for chemotherapy-refractory HER2-positive RAS wild-type metastatic colorectal cancer (Lancet Oncology 2023)","url":"https://doi.org/10.1016/S1470-2045(23)00150-X"}],"tags":[],"related":[],"cancers":["colorectal","her2-amplified-colorectal"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","monoclonal-antibody","kinase-inhibitors"],"targets":["her2"],"drugs":["tucatinib","trastuzumab","folfox","bevacizumab","cetuximab","oxaliplatin"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":["mountaineer","destiny-crc02"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05253651","phase":"3","setting":"First-line HER2-positive, RAS wild-type metastatic colorectal cancer: tucatinib with trastuzumab and mFOLFOX6 against mFOLFOX6 with bevacizumab or cetuximab","sponsor":"Seagen, a wholly owned subsidiary of Pfizer","started":"2022-10-24","startedType":"actual","yearReported":2027,"enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02338050","kind":"trial","name":"Moxetumomab Pasudotox (CAT-8015, HA22) in Children With B-lineage Acute Lymphoblastic Leukemia and Minimal Residual Disease Prior to Allogeneic Hematopoietic Stem Cell Transplantation","aka":[],"tldr":"A phase 2 trial of Moxetumomab pasudotox in Acute lymphoblastic leukaemia, run by Center for International Blood and Marrow Transplant Research, recorded as terminated on the registry.","summary":"Moxetumomab Pasudotox (CAT-8015, HA22) in Children With B-lineage Acute Lymphoblastic Leukemia and Minimal Residual Disease Prior to Allogeneic Hematopoietic Stem Cell Transplantation is a phase 2 interventional study registered as NCT02338050 by Center for International Blood and Marrow Transplant Research, with 1 participants recorded, started 2015-05 and due to reach its primary completion in 2020-05. Interventions recorded: Moxetumomab Pasudotox. Conditions recorded: Acute Lymphoblastic Leukemia (ALL).\n\nLinked to the drug Moxetumomab pasudotox because the registry names it among its interventions and Acute lymphoblastic leukaemia among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02338050","url":"https://clinicaltrials.gov/study/NCT02338050"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":[],"targets":[],"drugs":["moxetumomab-pasudotox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02338050","phase":"2","setting":"A Phase II Study of the Anti-CD22 Recombinant Immunotoxin Moxetumomab Pasudotox (CAT-8015, HA22) in Children With B-lineage Acute Lymphoblastic Leukemia and Minimal Residual Disease Prior to Allogeneic Hematopoietic Stem Cell Transplantation","sponsor":"Center for International Blood and Marrow Transplant Research","started":"2015-05","enrolled":1,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01829711","kind":"trial","name":"Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia","aka":[],"tldr":"A phase 3 trial of Moxetumomab pasudotox in Leukaemia, run by MedImmune LLC, completed.","summary":"Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia is a phase 3 interventional study registered as NCT01829711 by MedImmune LLC, with 80 participants recorded, started 2013-04-29 and reaching its primary completion in 2017-05-24. Interventions recorded: Moxetumomab pasudotox, IV Bag Protectant for Moxetumomab pasudotox. Conditions recorded: Leukemia, Hairy Cell.\n\nLinked to the drug Moxetumomab pasudotox because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01829711","url":"https://clinicaltrials.gov/study/NCT01829711"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["moxetumomab-pasudotox"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01829711","phase":"3","setting":"A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/ Refractory Hairy Cell Leukemia","sponsor":"MedImmune LLC","started":"2013-04-29","startedType":"actual","yearReported":2018,"enrolled":80,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Durable Complete Response (CR) Assessed by Blinded Independent Central Review","primary":true,"unit":"%","arms":[{"name":"Moxetumomab Pasudotox 40 µg/kg","n":80,"value":36.3,"note":"95% CI 25.8 to 47.8; Figures from the ClinicalTrials.gov results section (first posted 2018-08-27), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01829711?tab=results"},{"endpoint":"Percentage of Participants With Durable CR by Investigator's Assessment","primary":true,"unit":"%","arms":[{"name":"Moxetumomab Pasudotox 40 µg/kg","n":80,"value":48.8,"note":"95% CI 37.4 to 60.2; Figures from the ClinicalTrials.gov results section (first posted 2018-08-27), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01829711?tab=results"}]},{"id":"nct07036380","kind":"trial","name":"MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma","aka":["TACTIC"],"tldr":"A phase 2 trial of durvalumab, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by Centre Hospitalier Universitaire de Besancon, now recruiting.","summary":"MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma is a phase 2, randomised interventional study registered as NCT07036380 by Centre Hospitalier Universitaire de Besancon, with a registry enrolment figure of 75 participants, started 2025-12-22 and due to reach its primary completion in 2028-11. Interventions recorded: MP0317 + Gemcitabine + Cisplatine + Durvalumab, CT-Scan, Gemcitabine + Cisplatin + Durvalumab. Conditions listed: Advanced Biliary Tract Carcinoma. Gallbladder cancer is named in the registry entry: \"2. Histologically confirmed biliary tract carcinoma: intra/extrahepatic cholangiocarcinoma (note that gallbladder carcinoma are not eligible)\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07036380","url":"https://clinicaltrials.gov/study/NCT07036380"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["durvalumab","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07036380","phase":"2","setting":"MP0317, a Tumor Targeting FAP Dependent CD40 Agonist DARPin, in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma: a Radnomized Non-comparative Proof of Concept Phase II Study","sponsor":"Centre Hospitalier Universitaire de Besancon","started":"2025-12-22","startedType":"actual","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"mpact","kind":"trial","name":"MPACT","aka":["CA046","Metastatic Pancreatic Adenocarcinoma Clinical Trial"],"tldr":"MPACT established the second modern first-line regimen for advanced pancreatic cancer: adding albumin-bound paclitaxel to gemcitabine lengthened median survival from 6.7 to 8.5 months and doubled two-year survival, with more neuropathy and neutropenia; it is the option for people not fit enough for FOLFIRINOX and the control arm of most trials since.","summary":"MPACT randomised 861 patients (431 to nab-paclitaxel plus gemcitabine, 430 to gemcitabine) between 2009 and 2012. Median overall survival was 8.5 against 6.7 months (hazard ratio 0.72, 95 percent confidence interval 0.62 to 0.83; p below 0.001), one-year survival 35 against 22 percent and two-year survival 9 against 4 percent; median progression-free survival 5.5 against 3.7 months (hazard ratio 0.69) and independently reviewed response 23 against 7 percent. Grade 3 or worse neutropenia was 38 against 27 percent, fatigue 17 against 7 percent and peripheral neuropathy 17 against 1 percent, the neuropathy improving to grade 1 or less in a median 29 days after interruption; febrile neutropenia 3 against 1 percent. The long-term update (JNCI 2015) gave 8.7 against 6.6 months with 4 percent of the combination arm alive beyond three years and none on gemcitabine, and found high CA 19-9 and neutrophil-to-lymphocyte ratio prognostic. The FDA approved the combination in September 2013 and the EMA the same year (Abraxane product information); in England NICE TA476 (2017) restricts it to people for whom other combination chemotherapies are unsuitable and who would otherwise have gemcitabine alone. No UK sites took part.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00844649","url":"https://clinicaltrials.gov/study/NCT00844649"},{"label":"Von Hoff et al., increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine (NEJM 2013)","url":"https://doi.org/10.1056/NEJMoa1304369"},{"label":"Goldstein et al., MPACT long-term survival (JNCI 2015)","url":"https://doi.org/10.1093/jnci/dju413"},{"label":"Abraxane label (openFDA): adenocarcinoma of the pancreas study section","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ABRAXANE%22"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel","nab-paclitaxel","gemcitabine"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["peripheral-neuropathy","neutropenia","ca19-9"],"trials":[],"people":["daniel-von-hoff"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00844649","phase":"3","setting":"Untreated metastatic pancreatic adenocarcinoma with Karnofsky performance status 70 or more at 151 sites in 11 countries: nab-paclitaxel 125 mg/m2 followed by gemcitabine on days 1, 8 and 15 of 28 against gemcitabine alone, with overall survival as the primary endpoint","sponsor":"Celgene (Bristol Myers Squibb)","result":"Median overall survival 8.5 months with nab-paclitaxel plus gemcitabine against 6.7 months with gemcitabine (hazard ratio 0.72, 95 percent confidence interval 0.62 to 0.83; p below 0.001); progression-free survival 5.5 against 3.7 months; response 23 against 7 percent.","started":"2009-03-01","startedType":"actual","yearReported":2013,"enrolled":861,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nab-paclitaxel + gemcitabine","n":431,"value":8.5,"note":"95% CI 7.9 to 9.5"},{"name":"Gemcitabine","n":430,"value":6.7,"note":"95% CI 6.0 to 7.2"}],"hr":0.72,"ci":[0.62,0.83],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1304369"},{"endpoint":"Progression-free survival (independent review)","unit":"months","arms":[{"name":"Nab-paclitaxel + gemcitabine","value":5.5},{"name":"Gemcitabine","value":3.7}],"hr":0.69,"ci":[0.58,0.82],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1304369"},{"endpoint":"Grade 3 or worse peripheral neuropathy","unit":"%","arms":[{"name":"Nab-paclitaxel + gemcitabine","value":17},{"name":"Gemcitabine","value":1}],"source":"https://doi.org/10.1056/NEJMoa1304369"}]},{"id":"nct01377753","kind":"trial","name":"MR Image Guided Therapy in Prostate Cancer","aka":[],"tldr":"A phase 2 trial of Laser interstitial thermal therapy systems in Prostate cancer, run by National Cancer Institute (NCI), completed.","summary":"MR Image Guided Therapy in Prostate Cancer is a phase 2 interventional study registered as NCT01377753 by National Cancer Institute (NCI), with 15 participants recorded, started 2011-08-12 and reaching its primary completion in 2017-01-01. Interventions recorded: Visualase Thermal Therapy System. Conditions recorded: Prostate Cancer, Prostatic Neoplasms.\n\nLinked to the technology Laser interstitial thermal therapy systems because the registry names it (\"visualase\") among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01377753","url":"https://clinicaltrials.gov/study/NCT01377753"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["litt-systems"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01377753","phase":"2","setting":"MR Image Guided Focal Therapy in Prostate Cancer","sponsor":"National Cancer Institute (NCI)","started":"2011-08-12","startedType":"actual","enrolled":15,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06840665","kind":"trial","name":"MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of MR-guided adaptive radiotherapy in Rectal cancer, run by Fudan University, now recruiting.","summary":"MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer is a phase 2 interventional study registered as NCT06840665 by Fudan University, with 46 participants planned, started 2024-08-13 and due to reach its primary completion in 2026-08-12. Interventions recorded: PD-1 antibody, Oxaliplatin, Capecitabine. Conditions recorded: Locally Advanced Rectal Cancer.\n\nLinked to the technology MR-guided adaptive radiotherapy because the registry's title names it (\"mr guided adaptive radiotherapy\") and Rectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06840665","url":"https://clinicaltrials.gov/study/NCT06840665"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["mr-linac"],"targets":[],"drugs":["toripalimab","oxaliplatin","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06840665","phase":"2","setting":"A Prospective, Randomized, Phase II Trial of MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer","sponsor":"Fudan University","started":"2024-08-13","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"coin","kind":"trial","name":"MRC COIN","aka":["COIN","ISRCTN27286448"],"tldr":"The UK trial that checked whether adding an antibody to first-line chemotherapy for advanced bowel cancer helps people live longer, and found it does not.","summary":"COIN randomised people with advanced colorectal cancer to oxaliplatin-based chemotherapy with or without cetuximab, having pre-specified that the answer would be read in KRAS wild-type tumours where cetuximab could work. It did not extend overall survival even in that group, although response rates rose. Coming after the enthusiasm generated by CRYSTAL, the result checked the assumption that an anti-EGFR antibody belonged in every first-line regimen and left the NHS position, set by NICE TA439 in 2017, restricted to the RAS wild-type population with FOLFOX or FOLFIRI. Its companion COIN-B tested intermittent chemotherapy with intermittent or continuous cetuximab and supported treatment breaks.","status":"negative","asOf":"2026-09-24","links":[{"label":"Lancet 2011","url":"https://europepmc.org/article/MED/21641636"},{"label":"ISRCTN27286448","url":"https://www.isrctn.com/ISRCTN27286448"}],"tags":["uk","colorectal","anti-egfr"],"related":[],"cancers":["colorectal"],"sections":["chemotherapy"],"technologies":[],"targets":["kras","egfr"],"drugs":["cetuximab","folfox","capox","oxaliplatin"],"companies":["mrc-ctu"],"institutions":["oxford-cancer","velindre-cardiff"],"pathways":[],"terms":[],"trials":[],"people":["tim-maughan"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN27286448","phase":"3","setting":"Oxaliplatin-based first-line chemotherapy with or without cetuximab in advanced colorectal cancer, with a third arm of intermittent chemotherapy; the primary comparison was in KRAS wild-type tumours","sponsor":"Medical Research Council","result":"No overall survival gain from adding cetuximab to oxaliplatin-based first-line chemotherapy, including in KRAS wild-type disease.","yearReported":2011,"enrolled":1630,"enrolledBasis":"randomised","enrolledNote":"1,630 patients were randomised to the continuous chemotherapy comparison reported in the Lancet 2011 paper; the trial as a whole randomised 2,445 across its three arms.","outcomes":[]},{"id":"cr07","kind":"trial","name":"MRC CR07","aka":["CR07","NCIC-CTG C016","ISRCTN28785842"],"tldr":"The UK trial that settled how rectal cancer is treated before surgery: five days of radiotherapy for everyone beats waiting to see who needs it afterwards.","summary":"CR07 randomised 1,350 people with operable rectal cancer to a week of preoperative radiotherapy or to surgery first with chemoradiotherapy afterwards only if the pathologist found tumour at the circumferential resection margin. Local recurrence fell by 61 percent with preoperative radiotherapy (hazard ratio 0.39, 0.27 to 0.58, p < 0.0001), an absolute difference at three years of 6.2 percent (4.4 percent against 10.6 percent), and disease-free survival improved by 24 percent (0.76, 0.62 to 0.94, p = 0.013). Overall survival did not differ. The trial was led from Leeds with Phil Quirke's pathology, and its companion staging work (MERCURY) showed MRI could pick out who was at risk before any treatment began.","status":"positive","asOf":"2026-09-24","links":[{"label":"Lancet 2009","url":"https://europepmc.org/article/MED/19269519"},{"label":"ISRCTN28785842","url":"https://www.isrctn.com/ISRCTN28785842"}],"tags":["uk","rectal","radiotherapy"],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":["radiation","surgery"],"technologies":[],"targets":[],"drugs":[],"companies":["mrc-ctu"],"institutions":["leeds-cancer-centre"],"pathways":[],"terms":[],"trials":[],"people":["david-sebag-montefiore"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN28785842","phase":"3","setting":"Short-course preoperative radiotherapy (25 Gy in five fractions) against initial surgery with selective postoperative chemoradiotherapy (45 Gy in 25 fractions with fluorouracil) restricted to people with an involved circumferential resection margin; operable rectal adenocarcinoma, 80 centres in four countries","sponsor":"Medical Research Council","result":"Local recurrence at three years 4.4 percent with short-course preoperative radiotherapy against 10.6 percent with selective postoperative chemoradiotherapy (hazard ratio 0.39, 0.27 to 0.58); disease-free survival 77.5 percent against 71.5 percent; no overall survival difference.","yearReported":2009,"enrolled":1350,"enrolledBasis":"randomised","enrolledNote":"1,350 patients were randomly assigned in the Lancet 2009 report, matching the ISRCTN target of 1,350.","outcomes":[]},{"id":"nct05286957","kind":"trial","name":"MRD-guided Adjuvant Tislelizumab and Chemotherapy in Resected Stage IIA-IIIB NSCLC","aka":["Seagull"],"tldr":"A phase 2 trial in lung cancer, run by The First Affiliated Hospital of Zhengzhou University, now recruiting.","summary":"MRD-guided Adjuvant Tislelizumab and Chemotherapy in Resected Stage IIA-IIIB NSCLC is a phase 2, randomised interventional study registered as NCT05286957 by The First Affiliated Hospital of Zhengzhou University, with a registry enrolment figure of 60 participants, started 2022-06-20 and due to reach its primary completion in 2026-06-01. Interventions recorded: adjuvant tislelizumab and chemotherapy for MRD+ patients; adjuvant tislelizumab and chemotherapy for MRD+ patients; adjuvant chemotherapy for MRD- patients. Conditions listed: NSCLC. Primary outcome: 2-year PFS rate. Lung eligibility wording from the registry: \"Histologically confirmed primary NSCLC, postoperative stage is IIA, IIB, IIIA or T3N2IIIB\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05286957","url":"https://clinicaltrials.gov/study/NCT05286957"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05286957","phase":"2","setting":"Minimal Residual Disease (MRD)-Guided Adjuvant Tislelizumab and Chemotherapy in Resected Stage IIA-IIIB Non-small Cell Lung Cancer (NSCLC): a Randomized Controlled Phase II Study (Seagull)","sponsor":"The First Affiliated Hospital of Zhengzhou University","started":"2022-06-20","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07479485","kind":"trial","name":"MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II)","aka":[],"tldr":"A phase 1/2 trial of Pucotenlimab, Bevacizumab in hepatocellular carcinoma, run by Lepu Biopharma Co., Ltd., now recruiting.","summary":"MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II) is a phase 1/2 interventional study registered as NCT07479485 by Lepu Biopharma Co., Ltd., with 160 participants planned, started 2026-04-08 and due to reach its primary completion in 2028-04. Interventions recorded: MRG006A, Pucotenlimab, Bevacizumab, PD1/VEGF antibody, TKI. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07479485","url":"https://clinicaltrials.gov/study/NCT07479485"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":["pucotenlimab","bevacizumab"],"companies":["lepu-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07479485","phase":"1/2","setting":"An Open-Label, Multicenter, Phase I/II Study Evaluating MRG006A in Combination With Immune Checkpoint Inhibitors and Targeted Therapy in Patients With Advanced Hepatocellular Carcinoma","sponsor":"Lepu Biopharma Co., Ltd.","started":"2026-04-08","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"msb-gvhd001","kind":"trial","name":"MSB-GVHD001","aka":["MSB-GVHD 001"],"tldr":"MSB-GVHD001 showed that donor bone marrow stromal cells, given twice a week for a month, helped about seven in ten children whose acute graft-versus-host disease had not settled on steroids, which supported the first US approval of a mesenchymal stromal cell therapy in 2024.","summary":"MSB-GVHD001 was an open-label, single-arm phase 3 study of remestemcel-L, culture-expanded mesenchymal stromal cells from the bone marrow of healthy adult donors, in children with primary steroid-refractory acute graft-versus-host disease after a donor stem-cell transplant who were naive to other immunosuppressant therapies for it. According to the US label, patients had grade B to D disease (excluding grade B skin disease alone), 67 percent had been transplanted for a blood cancer and 33 percent for a non-malignant disease. Remestemcel-L was infused at 2 million cells per kilogram twice a week for four weeks (eight infusions). The primary endpoint was overall response (complete plus partial) at day 28, tested against a prespecified historical control rate of 45 percent.\n\nIn the 54 treated children the day-28 overall response was 70.4 percent (P = .0003 against 45 percent) and was sustained through day 100, with complete responses rising from 29.6 percent at day 28 to 44.4 percent at day 100. Overall survival was 74.1 percent at day 100 and 68.5 percent at day 180, and children who had responded by day 28 were more likely to be alive at day 100 (86.8 against 47.1 percent) and day 180 (78.9 against 43.8 percent). No infusion-related toxicities were identified (Biology of Blood and Marrow Transplantation 2020).\n\nThe US label reports the same 54 children as an overall response of 70 percent (38 of 54, 95% CI 56.4 to 82.0) with a median response duration of 54 days. The registry counts 55 participants in its full analysis set, one more than received treatment, and records the study as completed in April 2018. The FDA approved remestemcel-L (Ryoncil) in December 2024 for steroid-refractory acute graft-versus-host disease in children aged two months and older. The trial treats a complication of transplant rather than a cancer, so it carries no cancer ids.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02336230","url":"https://clinicaltrials.gov/study/NCT02336230"},{"label":"Biology of Blood and Marrow Transplantation 2020","url":"https://doi.org/10.1016/j.bbmt.2020.01.018"},{"label":"Ryoncil label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a4e0918f-7444-4694-adeb-d38d98345659"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["allogeneic-cell-therapy"],"targets":[],"drugs":["remestemcel-l"],"companies":["mesoblast"],"institutions":[],"pathways":[],"terms":["gvhd","allogeneic-transplant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-msb-gvhd001-bbmt-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02336230","phase":"3","setting":"Steroid-refractory acute graft-versus-host disease in children after allogeneic stem-cell transplant, with no second-line therapy for it yet: remestemcel-L alone, single arm, judged against a historical control","sponsor":"Mesoblast, Inc.","result":"Day-28 overall response 70.4% in 54 treated children, above the prespecified 45% historical control; overall survival 74.1% at day 100 and 68.5% at day 180.","started":"2015-06-04","startedType":"actual","yearReported":2020,"enrolled":55,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate at day 28 (complete plus partial)","primary":true,"unit":"%","arms":[{"name":"Remestemcel-L","n":54,"value":70.4,"note":"Against a prespecified historical control of 45%, P = .0003; complete response 29.6%"}],"source":"https://doi.org/10.1016/j.bbmt.2020.01.018"},{"endpoint":"Overall survival at day 100","unit":"%","arms":[{"name":"Remestemcel-L","n":54,"value":74.1}],"source":"https://doi.org/10.1016/j.bbmt.2020.01.018"},{"endpoint":"Overall survival at day 180","unit":"%","arms":[{"name":"Remestemcel-L","n":54,"value":68.5}],"source":"https://doi.org/10.1016/j.bbmt.2020.01.018"}]},{"id":"mslt-ii","kind":"trial","name":"MSLT-II","aka":[],"tldr":"Showed that removing all the remaining lymph nodes after a positive sentinel node does not help patients live longer, ending a routine operation.","summary":"MSLT-II, trial NCT00297895 sponsored by the John Wayne Cancer Institute and the NCI and reported in 2017, showed that removing all the remaining lymph nodes after a positive sentinel node in melanoma does not help patients live longer, ending a routine operation. It randomised 1,939 sentinel-node-positive patients to immediate completion dissection or ultrasound surveillance, found identical melanoma-specific survival at three years, and showed that dissection improved regional control only at the cost of lymphoedema in about a quarter of patients against six percent. Practice changed worldwide to nodal surveillance, and how best to use adjuvant and neoadjuvant systemic therapy in its place is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00297895","url":"https://clinicaltrials.gov/study/NCT00297895"},{"label":"NEJM 2017","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1613210"}],"tags":[],"related":[],"cancers":["melanoma","stage-iii-melanoma"],"sections":[],"technologies":["sentinel-node","ultrasound"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["mark-faries"],"bottlenecks":[],"keyPapers":["paper-mslt-ii-faries-nejm-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00297895","phase":"3","setting":"Sentinel-node-positive melanoma: immediate completion lymph node dissection vs ultrasound surveillance","sponsor":"John Wayne Cancer Institute / NCI","result":"No melanoma-specific survival benefit; lymphoedema 24% vs 6%.","started":"2004-09-30","startedType":"actual","yearReported":2017,"enrolled":1939,"enrolledBasis":"registry","outcomes":[{"endpoint":"Melanoma-specific survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Completion dissection","value":86},{"name":"Observation","value":86}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1613210"}],"replication":"DeCOG-SLT (Germany) reached the same conclusion."},{"id":"nct07174427","kind":"trial","name":"Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma","aka":[],"tldr":"A phase 3 trial testing TBI-1301 in sarcomas, now recruiting.","summary":"Multi-centre Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma is a phase 3 interventional study registered as NCT07174427, led by Takara Bio, and recruiting on the registry. Official title: Multi-centre Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma. Planned enrolment is 5 participants (estimated). The study started in 2026-01-05 and primary completion is expected in 2032-03. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07174427","url":"https://clinicaltrials.gov/study/NCT07174427"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sarcoma","synovial-sarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["tbi-1301"],"companies":["takara-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07174427","phase":"3","setting":"Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma","sponsor":"Takara Bio","started":"2026-01-05","startedType":"actual","enrolled":5,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01310803","kind":"trial","name":"Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder","aka":[],"tldr":"A phase 3 trial of Valrubicin in Non-muscle-invasive bladder cancer, run by Endo USA Inc., a Keenova Therapeutics Company, recorded as terminated on the registry.","summary":"Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder is a phase 3 interventional study registered as NCT01310803 by Endo USA Inc., a Keenova Therapeutics Company, with 1 participants recorded, started 2011-05 and due to reach its primary completion in 2012-01. Interventions recorded: VALSTAR - Maintenance Therapy, No Maintenance treatment ( Standard of Care). Conditions recorded: Carcinoma in Situ, Transitional Cell Carcinoma, Non-muscle Invasive Bladder Cancer.\n\nLinked to the drug Valrubicin because the registry names it among its interventions and Non-muscle-invasive bladder cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01310803","url":"https://clinicaltrials.gov/study/NCT01310803"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["valrubicin"],"companies":["endo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01310803","phase":"3","setting":"A PHASE 3B, RANDOMIZED, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MAINTENANCE THERAPY WITH VALRUBICIN VERSUS NO MAINTENANCE, IN SUBJECTS TREATED WITH VALRUBICIN INDUCTION FOR CARCINOMA IN SITU (CIS) OF THE BLADDER","sponsor":"Endo USA Inc., a Keenova Therapeutics Company","started":"2011-05","enrolled":1,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03439709","kind":"trial","name":"Multicenter Evaluation of the Effect of Upfront Radiosurgery on Residual Growth Hormone-secreting Pituitary Adenoma","aka":["MERGE"],"tldr":"A phase 3 trial of Gamma Knife in Pituitary tumours, run by Samsung Medical Center, with a status the registry has not verified recently.","summary":"Multicenter Evaluation of the Effect of Upfront Radiosurgery on Residual Growth Hormone-secreting Pituitary Adenoma is a phase 3 interventional study registered as NCT03439709 by Samsung Medical Center, with 90 participants planned, started 2018-03-01 and due to reach its primary completion in 2022-06-30. Interventions recorded: Gamma knife radiosurgery, Lanreotide 60Mg Solution for Injection. Conditions recorded: Acromegaly Due to Pituitary Adenoma.\n\nLinked to the technology Gamma Knife because the registry names it (\"gamma knife\") among its interventions and Pituitary tumours among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03439709","url":"https://clinicaltrials.gov/study/NCT03439709"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pituitary-tumours"],"sections":[],"technologies":["gamma-knife"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03439709","phase":"3","setting":"Multicenter Evaluation of the Effect of Upfront Radiosurgery on Residual Growth Hormone-secreting Pituitary Adenoma From an Endocrinological Point of View (MERGE Study): a Randomized, Phase 3 Trial","sponsor":"Samsung Medical Center","started":"2018-03-01","startedType":"estimated","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04910386","kind":"trial","name":"Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers","aka":[],"tldr":"A phase 2 trial of envafolimab, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by 3D Medicines (Sichuan) Co., Ltd., not yet recruiting.","summary":"Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers is a phase 2, randomised interventional study registered as NCT04910386 by 3D Medicines (Sichuan) Co., Ltd., with a registry enrolment figure of 126 participants, started 2027-06-01 and due to reach its primary completion in 2029-06. Interventions recorded: Envafolimab plus Gemcitabine&Cisplatin, Gemcitabine&Cisplatin. Conditions listed: Biliary Tract Neoplasms. Gallbladder cancer is named in the registry entry: \"2. Subjects must have a histopathological or cytological diagnosis of locally advanced or metastatic gallbladder cancer (GBC) or cholangiocarcinoma (CCA);\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04910386","url":"https://clinicaltrials.gov/study/NCT04910386"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["envafolimab","gemcitabine","cisplatin"],"companies":["3d-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04910386","phase":"2","setting":"A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers","sponsor":"3D Medicines (Sichuan) Co., Ltd.","started":"2027-06-01","startedType":"estimated","enrolled":126,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06782412","kind":"trial","name":"Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Dif","aka":["FAPIDO"],"tldr":"A phase 2/3 trial in pancreatic cancer, run by KU Leuven, now recruiting.","summary":"Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types is a phase 2/3, interventional study registered as NCT06782412 by KU Leuven, with a registry enrolment figure of 109 participants, started 2025-02-06 and due to reach its primary completion in 2027-12. Interventions recorded: [18F]AlF-FAPI-74 PET/CT. Conditions listed: Oesophageal Cancer; Gastric Cancer; Pancreatic Ductal Adenocarcinoma; FAP; Oncology; Oncologic Disorders. Primary outcome: Primary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [18F]FDG PET/CT.; Primary Objective PDAC: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over conventional imaging (CT or MRI) or [18F]FDG PET/CT (if available); Primary Objective Clinically Challenging Situation: dem. Pancreatic eligibility wording from the registry: \"New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma\". Sites: Belgium. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06782412","url":"https://clinicaltrials.gov/study/NCT06782412"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06782412","phase":"2/3","setting":"Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types","sponsor":"KU Leuven","started":"2025-02-06","startedType":"actual","enrolled":109,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07371208","kind":"trial","name":"Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer","aka":["ST-A-TN"],"tldr":"A phase 2 trial of sacituzumab tirumotecan in triple-negative breast cancer, run by Shanghai Jiao Tong University School of Medicine, now recruiting.","summary":"Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer is a phase 2, interventional study registered as NCT07371208 by Shanghai Jiao Tong University School of Medicine, with a registry enrolment figure of 40 participants, started 2025-12-24 and due to reach its primary completion in 2028-08. Interventions recorded: SKB264. Conditions listed: Breast Cancer. Triple-negative eligibility wording from the registry: \"* Diagnosis: Histologically and/or cytologically confirmed primary triple-negative breast cancer (TNBC) (excluding inflammatory breast cancer), meeting the criteria of tumor size ≥2 cm, clinical lymph node stage cN0 to cN3, and M0 (no distant metastasis)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07371208","url":"https://clinicaltrials.gov/study/NCT07371208"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-tirumotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07371208","phase":"2","setting":"Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer","sponsor":"Shanghai Jiao Tong University School of Medicine","started":"2025-12-24","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06610734","kind":"trial","name":"Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined With Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Ext","aka":["SKY"],"tldr":"A phase 2 trial of adebrelimab in lung cancer, run by Sichuan University, now recruiting.","summary":"Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined With Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC) is a phase 2, randomised interventional study registered as NCT06610734 by Sichuan University, with a registry enrolment figure of 202 participants, started 2024-12-23 and due to reach its primary completion in 2026-12. Interventions recorded: Adebrelimab; Chemotherapy; low dose radiotherapy. Conditions listed: Small Cell Lung Cancer Extensive Stage. Primary outcome: overall survival. Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed extensive small cell lung cancer (according to the VALG staging system);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06610734","url":"https://clinicaltrials.gov/study/NCT06610734"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06610734","phase":"2","setting":"Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined With Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)","sponsor":"Sichuan University","started":"2024-12-23","startedType":"actual","enrolled":202,"enrolledBasis":"registry","outcomes":[]},{"id":"mumbai-via-screening","kind":"trial","name":"Mumbai VIA cervical screening trial (Tata Memorial)","aka":[],"tldr":"Health workers with a torch and vinegar, screening women in Mumbai's slums every two years, cut cervical cancer deaths by 31% in a trial of more than 150,000 women.","summary":"75,360 women in ten screening clusters and 76,178 in ten control clusters were enrolled; screening participation was 89% and compliance with diagnostic confirmation 79.4%. Invasive cervical cancer incidence was similar (26.74 versus 27.49 per 100,000) but cervical cancer mortality fell by 31% (rate ratio 0.69; 95% CI 0.54-0.88; P=0.003), with better treatment completion in the screened group (86.3% versus 72.3%). The authors estimated that this approach could prevent about 22,000 cervical cancer deaths a year in India. Together with Osmanabad it shaped India's operational guidelines for population screening where HPV testing is not yet affordable.","status":"positive","asOf":"2026-09-10","links":[{"label":"Shastri et al., JNCI 2014","url":"https://doi.org/10.1093/jnci/dju009"}],"tags":[],"related":[],"cancers":["cervical"],"sections":[],"technologies":["hpv-testing","colposcopy-excision"],"targets":[],"drugs":[],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":[],"trials":["osmanabad-hpv-screening"],"people":["shastri-surendra"],"bottlenecks":["b-early-detection","b-workforce","b-global-access"],"keyPapers":["paper-shastri-j-natl-cancer-inst"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Cluster-randomised trial in 20 slum clusters of Mumbai: visual inspection with acetic acid by trained primary health workers every 2 years vs health education, women aged 35-64","sponsor":"Tata Memorial Centre","result":"Cervical cancer mortality rate ratio 0.69 (31% reduction).","yearReported":2014,"enrolled":151538,"enrolledBasis":"registry","outcomes":[{"endpoint":"Cervical cancer mortality (rate ratio)","primary":true,"arms":[{"name":"VIA screening by health workers","n":75360,"value":0.69,"note":"Rate ratio vs control; 95% CI 0.54-0.88"}],"p":"0.003","source":"https://doi.org/10.1093/jnci/dju009"}]},{"id":"murano","kind":"trial","name":"MURANO","aka":[],"tldr":"MURANO showed that a fixed two-year course of the BCL2 inhibitor venetoclax with rituximab kept relapsed chronic lymphocytic leukaemia away for far longer than chemo-immunotherapy, and that many patients stayed in remission for years after stopping.","summary":"MURANO randomised 389 patients with relapsed or refractory chronic lymphocytic leukaemia to venetoclax for two years plus rituximab for the first six months, or to six cycles of bendamustine and rituximab. The primary endpoint was investigator-assessed progression-free survival.\n\nVenetoclax-rituximab lengthened progression-free survival dramatically and produced far higher rates of undetectable minimal residual disease in blood and marrow, which predicted long remissions after therapy stopped. Overall survival also favoured the venetoclax arm with longer follow-up. The regimen was approved in the United States in June 2018 and made fixed-duration, chemotherapy-free treatment the model that the later CLL14 and CLL13 trials carried into first-line use.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02005471","url":"https://clinicaltrials.gov/study/NCT02005471"}],"tags":["subtype-trials"],"related":[],"cancers":["cll-relapsed","cll"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["venetoclax","rituximab","bendamustine"],"companies":["roche-genentech","abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["john-seymour"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02005471","phase":"3","setting":"Relapsed or refractory chronic lymphocytic leukaemia: two years of venetoclax with six cycles of rituximab against six cycles of bendamustine and rituximab","sponsor":"Hoffmann-La Roche","result":"Venetoclax plus rituximab greatly lengthened progression-free survival compared with bendamustine-rituximab, with high rates of undetectable minimal residual disease; approved in June 2018.","started":"2014-03-17","startedType":"actual","yearReported":2018,"enrolled":389,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 2 years (investigator-assessed)","primary":true,"unit":"%","arms":[{"name":"Venetoclax + rituximab","n":194,"value":84.9,"note":"Median follow-up 23.8 months"},{"name":"Bendamustine + rituximab","n":195,"value":36.3}],"hr":0.17,"ci":[0.11,0.25],"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1713976"},{"endpoint":"Progression-free survival at 2 years, chromosome 17p deletion","unit":"%","arms":[{"name":"Venetoclax + rituximab","value":81.5},{"name":"Bendamustine + rituximab","value":27.8}],"hr":0.13,"ci":[0.05,0.29],"source":"https://doi.org/10.1056/nejmoa1713976"},{"endpoint":"Progression-free survival at 2 years, no 17p deletion","unit":"%","arms":[{"name":"Venetoclax + rituximab","value":85.9},{"name":"Bendamustine + rituximab","value":41}],"hr":0.19,"ci":[0.12,0.32],"source":"https://doi.org/10.1056/nejmoa1713976"},{"endpoint":"Grade 3-4 tumour lysis syndrome","unit":"%","arms":[{"name":"Venetoclax + rituximab","n":194,"value":3.1,"note":"6 of 194 patients"}],"source":"https://doi.org/10.1056/nejmoa1713976"}]},{"id":"nct04146298","kind":"trial","name":"Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of cyclophosphamide and fludarabine in pancreatic cancer, run by Changhai Hospital, now recruiting.","summary":"Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer is a phase 1/2, interventional study registered as NCT04146298 by Changhai Hospital, with a registry enrolment figure of 30 participants, started 2021-10-21 and due to reach its primary completion in 2027-06. Interventions recorded: Cyclophosphamide; Fludarabine; Mutant KRAS G12V-specific TCR transduced autologous T cells; Anti-PD-1 monoclonal antibody. Conditions listed: Pancreatic Cancer; Pancreatic Neoplasms; Pancreatic Ductal Adenocarcinoma; Advanced Cancer. Primary outcome: Frequency and severity of treatment-related adverse events; Objective response rate. Pancreatic eligibility wording from the registry: \"* Patients with measurable and pathologically confirmed advanced pancreatic cancer, including metastatic pancreatic cancer (who have received standard chemotherapy) and recurrent pancreatic cancer (who have received surgery and adjuvant chemotherapy previously)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04146298","url":"https://clinicaltrials.gov/study/NCT04146298"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cyclophosphamide","fludarabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04146298","phase":"1/2","setting":"Clinical Trial Evaluating the Safety and Activity of Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer","sponsor":"Changhai Hospital","started":"2021-10-21","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"myelomatch","kind":"trial","name":"myeloMATCH","aka":[],"tldr":"myeloMATCH is a US-wide master trial that sequences every new leukaemia within days and routes the patient to the right experimental arm, then re-routes them as MRD results come in.","summary":"Launched 2024 across ~200 sites. Rapid central genomics (results in 72 hours) and MRD assessments at each 'tier' allow patients to move between sub-studies (e.g., FLT3, TP53, NPM1, older-unfit cohorts) testing venetoclax, menin inhibitors, FLT3 inhibitors, magrolimab successors, and CPX-351. The infrastructure model for precision leukaemia trials.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05564390","url":"https://clinicaltrials.gov/study/NCT05564390"}],"tags":[],"related":[],"cancers":["aml"],"sections":[],"technologies":["ngs-mrd-clonoseq","cgp"],"targets":[],"drugs":["ziftomenib","cpx-351","venetoclax"],"companies":[],"institutions":["nci"],"pathways":[],"terms":["mrd-negative-cr","basket-umbrella-platform"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05564390","phase":"platform","setting":"Newly diagnosed AML and MDS: genomic screening at diagnosis assigns patients to tiered, biomarker-defined sub-studies from induction through MRD-guided consolidation and maintenance","sponsor":"NCI / National Clinical Trials Network","started":"2024-06-18","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"mypathway","kind":"trial","name":"MyPathway","aka":["My Pathway","MyPathway basket"],"tldr":"MyPathway was Roche's basket trial: six of its approved drugs given to people whose tumours carried the matching target but in a cancer the drug was never approved for. Its clearest win was trastuzumab plus pertuzumab in HER2-amplified bowel cancer, which became a guideline option.","summary":"MyPathway opened in April 2014 as an open-label, multi-basket phase 2 run by Genentech at community and academic sites in the United States. Patients whose tumours carried a HER2 alteration, an EGFR mutation, a BRAF mutation, a Hedgehog pathway alteration, an ALK rearrangement or, later, high tumour mutational burden or microsatellite instability received the matching approved drug outside its licensed indication, with objective response as the endpoint in each drug-by-tumour cohort. It enrolled 673 patients before completing.\n\nThe first report, by John Hainsworth and colleagues in the Journal of Clinical Oncology in 2018, covered 230 treated patients and found responses in 23 percent overall, with the strongest signals for trastuzumab plus pertuzumab in HER2-amplified colorectal cancer and for vemurafenib in BRAF V600-mutant non-melanoma cancers. The updated colorectal cohort, in the Lancet Oncology in 2019, reported a response rate of 32 percent in 57 patients with HER2-amplified, treatment-refractory disease, most durable in RAS wild-type tumours; that result put trastuzumab plus pertuzumab into United States guidelines for HER2-amplified colorectal cancer. The atezolizumab cohort, in Cancer Discovery in 2022, showed that response to single-agent PD-L1 blockade in unselected tumours rose with tumour mutational burden and was concentrated in the most highly mutated tumours.\n\nMyPathway is the industry counterpart to NCI-MATCH and TAPUR, and the model for Roche's later TAPISTRY platform. It showed a company could generate label-adjacent evidence cheaply from a basket, and it produced two of the more reliable tumour-agnostic signals (HER2 amplification for dual HER2 blockade and BRAF V600 for BRAF inhibition) alongside many cohorts with little activity.","status":"completed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02091141","url":"https://clinicaltrials.gov/study/NCT02091141"},{"label":"Hainsworth et al., Journal of Clinical Oncology 2018: targeted therapy for advanced solid tumors on the basis of molecular profiles, results from MyPathway","url":"https://doi.org/10.1200/JCO.2017.75.3780"},{"label":"Meric-Bernstam et al., Lancet Oncology 2019: pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer (MyPathway)","url":"https://doi.org/10.1016/S1470-2045(18)30904-5"},{"label":"Friedman et al., Cancer Discovery 2022: atezolizumab treatment of tumors with high tumor mutational burden from MyPathway","url":"https://doi.org/10.1158/2159-8290.CD-21-0450"}],"tags":[],"related":[],"cancers":["colorectal","rare-cancers","gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cgp","checkpoint-inhibitor","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["trastuzumab","pertuzumab","erlotinib","vemurafenib","cobimetinib","vismodegib","alectinib","atezolizumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["master-protocol","basket-umbrella-platform","tumour-agnostic","tmb","gallbladder-cancer-in-biliary-trials"],"trials":["nct04589845"],"people":["funda-meric-bernstam"],"bottlenecks":[],"keyPapers":["paper-javle-mypathway-her2-biliary-lancet-oncol-2021","paper-friedman-cancer-discov","paper-hainsworth-j-clin-oncol","paper-mypathway-lancet-oncol-2019"],"journals":[],"dependsOn":[],"notes":["Biliary tract cancer cohort (Javle et al., Lancet Oncology 2021): 39 previously treated patients with HER2 amplification, overexpression or both from 23 US sites received pertuzumab 840 mg then 420 mg with trastuzumab 8 then 6 mg/kg every 3 weeks; 9 achieved a partial response (23 percent) at a median follow-up of 8.1 months, the first prospective evidence for dual HER2 antibody therapy in biliary cancer and the basis of the UK DETERMINE trastuzumab-pertuzumab arm open to HER2-amplified gallbladder cancer. The proportion with gallbladder cancer is in the paper's tables, not its abstract."],"nct":"NCT02091141","phase":"2","setting":"Advanced solid tumours with alterations in HER2, EGFR, BRAF, the Hedgehog pathway, ALK or high tumour mutational burden, outside the cancers for which the matching Roche drug is approved: trastuzumab with pertuzumab, erlotinib, vemurafenib with cobimetinib, vismodegib, alectinib or atezolizumab","sponsor":"Genentech","result":"Response in 23 percent of the first 230 patients; trastuzumab plus pertuzumab gave a 32 percent response rate in HER2-amplified colorectal cancer, now a guideline option; atezolizumab activity rose with tumour mutational burden.","started":"2014-04-14","startedType":"actual","yearReported":2018,"enrolled":673,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response, trastuzumab plus pertuzumab in HER2-amplified colorectal cancer","unit":"%","arms":[{"name":"Treated patients","n":57,"value":32}],"source":"https://doi.org/10.1016/S1470-2045(18)30904-5"},{"endpoint":"Objective response, trastuzumab plus pertuzumab in HER2-amplified or overexpressing metastatic biliary tract cancer (investigator-assessed)","unit":"%","arms":[{"name":"Treated patients","n":39,"value":23,"note":"9 partial responses; 95% CI 11 to 39; grade 3 to 4 treatment-emergent adverse events in 46%"}],"source":"https://doi.org/10.1016/S1470-2045(21)00336-3"}]},{"id":"nct07639450","kind":"trial","name":"N-3C01 Monotherapy and Combination With PD-(L)1 Inhibitors in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by Hefei Xinzhu Biological Technology Co., Ltd., now recruiting.","summary":"N-3C01 Monotherapy and Combination With PD-(L)1 Inhibitors in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07639450 by Hefei Xinzhu Biological Technology Co., Ltd., with 114 participants planned, started 2026-06-15 and due to reach its primary completion in 2028-08-31. Interventions recorded: N-3C01(Q2W), N-3C01(Q3W), N-3C01 and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07639450","url":"https://clinicaltrials.gov/study/NCT07639450"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07639450","phase":"1/2","setting":"A Phase I/II Clinical Study Evaluating the Safety, Tolerability, and Efficacy of N-3C01 as Monotherapy and in Combination With PD-(L)1 Monoclonal Antibody in Patients With Advanced Malignant Solid Tumors","sponsor":"Hefei Xinzhu Biological Technology Co., Ltd.","started":"2026-06-15","startedType":"actual","enrolled":114,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06061809","kind":"trial","name":"N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma","aka":[],"tldr":"A phase 2 trial of Bevacizumab and Nogapendekin alfa inbakicept in glioma & glioblastoma, run by ImmunityBio, Inc., active and no longer recruiting.","summary":"N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma is a phase 2 interventional study registered as NCT06061809 by ImmunityBio, Inc., with 34 participants enrolled, started 2024-08-07 and due to reach its primary completion in 2029-12-31. Interventions recorded: Bevacizumab, PD-L1 t-haNK, N-803 and Tumor Treating Fields (TTFields, 200 kHz).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06061809","url":"https://clinicaltrials.gov/study/NCT06061809"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["antiangiogenic","cytokine-therapy","monoclonal-antibody"],"targets":[],"drugs":["bevacizumab","nogapendekin-alfa"],"companies":["immunitybio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06061809","phase":"2","setting":"Open-Label, Single-Arm Phase 2 Study of Nogapendekin Alfa Inbakicept, PD-L1 t-haNK, Bevacizumab and Randomized Phase 2B Study of Nogapendekin Alfa Inbakicept, Bevacizumab, and Tumor Treatment Fields With or Without PD-L1 t-haNK in Participants With Recurrent or Progressive Glioblastoma","sponsor":"ImmunityBio, Inc.","started":"2024-08-07","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06817525","kind":"trial","name":"Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Henan Cancer Hospital, now recruiting.","summary":"Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC is a phase 2, randomised interventional study registered as NCT06817525 by Henan Cancer Hospital, with a registry enrolment figure of 64 participants, started 2024-11-06 and due to reach its primary completion in 2026-05-31. Interventions recorded: 6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1); 6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (d 1). Conditions listed: Triple-negative Breast Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06817525","url":"https://clinicaltrials.gov/study/NCT06817525"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06817525","phase":"2","setting":"Nab-P+Cb+PD1 Inhibitor Neoadjuvant Therapy for Early TNBC: a Single Center, Non Blinded, Randomized Phase II Clinical Trial","sponsor":"Henan Cancer Hospital","started":"2024-11-06","startedType":"actual","enrolled":64,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04605913","kind":"trial","name":"Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Mayo Clinic, now recruiting.","summary":"Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC is a phase 1/2, interventional study registered as NCT04605913 by Mayo Clinic, with a registry enrolment figure of 40 participants, started 2022-04-01 and due to reach its primary completion in 2027-10-01. Interventions recorded: Modified GCN+TTF treatment. Conditions listed: Pancreas Cancer; Metastatic Pancreatic Cancer; Pancreatic Adenocarcinoma; Metastatic Adenocarcinoma. Primary outcome: Safety of (m)-GCN+TTF. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04605913","url":"https://clinicaltrials.gov/study/NCT04605913"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04605913","phase":"1/2","setting":"A Phase I/Ib Pilot Trial, Single Arm, Open Label, of Protein-Bound Paclitaxel, Cisplatin, and Gemcitabine (GCN) Combined With Tumor Treatment Fields (TTF) in Patient With Metastatic Pancreatic Adenocarcinoma","sponsor":"Mayo Clinic","started":"2022-04-01","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04159142","kind":"trial","name":"Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of nab-paclitaxel, carboplatin and capecitabine in triple-negative breast cancer, run by Hebei Medical University Fourth Hospital, now recruiting.","summary":"Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer is a phase 2, randomised interventional study registered as NCT04159142 by Hebei Medical University Fourth Hospital, with a registry enrolment figure of 414 participants, started 2019-11-20 and due to reach its primary completion in 2026-06-20. Interventions recorded: Nab-paclitaxel + Carboplatin; Nab-paclitaxel + Capecitabine. Conditions listed: Triple Negative Breast Cancer; Nab-paclitaxel. Triple-negative eligibility wording from the registry: \"Histologically confirmed triple negative breast cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04159142","url":"https://clinicaltrials.gov/study/NCT04159142"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["nab-paclitaxel","carboplatin","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04159142","phase":"2","setting":"Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer","sponsor":"Hebei Medical University Fourth Hospital","started":"2019-11-20","startedType":"actual","enrolled":414,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04138719","kind":"trial","name":"Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer","aka":[],"tldr":"A phase 2 trial of nab-paclitaxel, carboplatin and epirubicin in triple-negative breast cancer, run by Hebei Medical University Fourth Hospital, now recruiting.","summary":"Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer is a phase 2, randomised interventional study registered as NCT04138719 by Hebei Medical University Fourth Hospital, with a registry enrolment figure of 520 participants, started 2019-11-20 and due to reach its primary completion in 2026-10-20. Interventions recorded: Nab-paclitaxel + Carboplatin; Nab-paclitaxel + Epirubicin. Conditions listed: Breast Cancer; Triple-negative Breast Cancer; Nab-paclitaxel. Triple-negative eligibility wording from the registry: \"Histologically confirmed triple negative breast cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04138719","url":"https://clinicaltrials.gov/study/NCT04138719"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["nab-paclitaxel","carboplatin","epirubicin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04138719","phase":"2","setting":"Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer","sponsor":"Hebei Medical University Fourth Hospital","started":"2019-11-20","startedType":"actual","enrolled":520,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02802540","kind":"trial","name":"Nabilone Effect on the Attenuation of Anorexia, Nutritional Status and Quality of Life in Lung Cancer Patients","aka":[],"tldr":"A phase 2/3 trial of Nabilone in Non-small-cell lung cancer, run by Instituto Nacional de Cancerologia de Mexico, with a status the registry has not verified recently.","summary":"Nabilone Effect on the Attenuation of Anorexia, Nutritional Status and Quality of Life in Lung Cancer Patients is a phase 2/3 interventional study registered as NCT02802540 by Instituto Nacional de Cancerologia de Mexico, with 78 participants planned, started 2014-12 and due to reach its primary completion in 2017-07. Interventions recorded: Nabilone, Placebo. Conditions recorded: Non-Small Cell Lung Cancer, Anorexia, Cachexia, Weight Lose.\n\nLinked to the drug Nabilone because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02802540","url":"https://clinicaltrials.gov/study/NCT02802540"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["nabilone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02802540","phase":"2/3","setting":"Nabilone Effect on the Attenuation of Anorexia, Nutritional Status and Quality of Life in Patients With Anorexia Associated With Advanced Lung Cancer: Randomized Double Blind Clinical Trial","sponsor":"Instituto Nacional de Cancerologia de Mexico","started":"2014-12","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nadina","kind":"trial","name":"NADINA","aka":[],"tldr":"Giving the immunotherapy doublet before surgery, instead of nivolumab after, cut the risk of recurrence by about two thirds and let most patients skip further treatment.","summary":"Presented at the ASCO 2024 plenary and published in NEJM (June 2024). 12-month EFS 83.7% vs 57.2%; HR for progression, recurrence or death 0.32. Around 59% of the neoadjuvant arm had a major pathological response and received no adjuvant therapy. The first phase 3 in oncology to test an immunotherapy-only neoadjuvant regimen against standard of care; adopted into NCCN and ESMO guidance as a preferred option for resectable nodal disease.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04949113","url":"https://clinicaltrials.gov/study/NCT04949113"},{"label":"NEJM 2024","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2402604"}],"tags":[],"related":[],"cancers":["melanoma","stage-iii-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","ctla4"],"drugs":["nivolumab","ipilimumab"],"companies":[],"institutions":["nki"],"pathways":[],"terms":["neoadjuvant-adjuvant","efs","major-pathological-response"],"trials":[],"people":["georgina-long","christian-blank"],"bottlenecks":[],"keyPapers":["paper-nadina-nejm-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04949113","phase":"3","setting":"Resectable macroscopic stage III melanoma: two cycles neoadjuvant ipilimumab + nivolumab then surgery (adjuvant only if incomplete response) vs surgery then 12 cycles adjuvant nivolumab","sponsor":"Netherlands Cancer Institute / Melanoma Institute Australia","result":"12-month EFS 83.7% vs 57.2%; HR 0.32.","started":"2021-07-08","startedType":"actual","yearReported":2024,"enrolled":423,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 12 months","primary":true,"unit":"%","arms":[{"name":"Neoadjuvant ipilimumab + nivolumab","value":83.7},{"name":"Adjuvant nivolumab","value":57.2}],"hr":0.32,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2402604"}],"replication":"SWOG S1801 (neoadjuvant pembrolizumab) independently showed an EFS benefit for the neoadjuvant sequence, with a different drug."},{"id":"nct06662006","kind":"trial","name":"Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, now recruiting.","summary":"Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients is a phase 2, interventional study registered as NCT06662006 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, with a registry enrolment figure of 56 participants, started 2024-03-01 and due to reach its primary completion in 2027-12. Interventions recorded: nal-IRI,5-fu,LV, benmelstobart, anlotinib. Conditions listed: Advanced Metastatic Pancreatic Cancer. Primary outcome: Objective effective rate (ORR). Pancreatic eligibility wording from the registry: \"Patients with histologically or cytologically confirmed advanced metastatic pancreatic cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06662006","url":"https://clinicaltrials.gov/study/NCT06662006"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06662006","phase":"2","setting":"Efficacy and Safety of Second-line Therapy by Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT in Metastatic Pancreatic Cancer Patients: a Prospective, Multicentre, Single-arm, Multi-cohort Study","sponsor":"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","started":"2024-03-01","startedType":"actual","enrolled":56,"enrolledBasis":"registry","outcomes":[]},{"id":"nala","kind":"trial","name":"NALA","aka":[],"tldr":"NALA showed that the irreversible HER2 inhibitor neratinib, given with capecitabine, kept heavily pretreated HER2-positive breast cancer under control for longer than lapatinib and reduced the need for treatment of brain metastases.","summary":"NALA randomised 621 patients with HER2-positive metastatic breast cancer who had received two or more prior HER2-directed regimens to neratinib plus capecitabine or lapatinib plus capecitabine. The co-primary endpoints were progression-free and overall survival.\n\nNeratinib improved progression-free survival, with a smaller and non-significant difference in overall survival, and fewer patients needed intervention for central nervous system metastases. Diarrhoea was the dominant toxicity and requires prophylaxis. The regimen was approved in the United States in February 2020 for third-line or later HER2-positive metastatic disease.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01808573","url":"https://clinicaltrials.gov/study/NCT01808573"}],"tags":["subtype-trials"],"related":[],"cancers":["her2-positive-breast-brain-metastases","breast-her2-positive","breast-cancer"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["neratinib","capecitabine","lapatinib"],"companies":["puma-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["cristina-saura"],"bottlenecks":[],"keyPapers":["paper-nala-j-clin-oncol-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01808573","phase":"3","setting":"HER2-positive metastatic breast cancer after two or more HER2-directed regimens: neratinib plus capecitabine against lapatinib plus capecitabine","sponsor":"Puma Biotechnology","result":"Neratinib plus capecitabine improved progression-free survival over lapatinib plus capecitabine and reduced interventions for central nervous system disease; approved in February 2020.","started":"2013-03-29","startedType":"actual","yearReported":2020,"enrolled":621,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (central review)","primary":true,"arms":[{"name":"Neratinib + capecitabine","n":307,"note":"Medians not reported in the abstract"},{"name":"Lapatinib + capecitabine","n":314}],"hr":0.76,"ci":[0.63,0.93],"p":"0.0059","source":"https://doi.org/10.1200/jco.20.00147"},{"endpoint":"Overall survival","primary":true,"arms":[{"name":"Neratinib + capecitabine","n":307},{"name":"Lapatinib + capecitabine","n":314}],"hr":0.88,"ci":[0.72,1.07],"p":"0.2098","source":"https://doi.org/10.1200/jco.20.00147"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Neratinib + capecitabine","n":307,"value":32.8},{"name":"Lapatinib + capecitabine","n":314,"value":26.7}],"p":"0.1201","source":"https://doi.org/10.1200/jco.20.00147"},{"endpoint":"Duration of response","unit":"months","arms":[{"name":"Neratinib + capecitabine","n":307,"value":8.5},{"name":"Lapatinib + capecitabine","n":314,"value":5.6}],"hr":0.5,"ci":[0.33,0.74],"p":"0.0004","source":"https://doi.org/10.1200/jco.20.00147"},{"endpoint":"Intervention for CNS disease (cumulative incidence)","unit":"%","arms":[{"name":"Neratinib + capecitabine","n":307,"value":22.8},{"name":"Lapatinib + capecitabine","n":314,"value":29.2}],"p":"0.043","source":"https://doi.org/10.1200/jco.20.00147"},{"endpoint":"Diarrhoea (all grades)","unit":"%","arms":[{"name":"Neratinib + capecitabine","n":307,"value":83,"note":"Loperamide prophylaxis"},{"name":"Lapatinib + capecitabine","n":314,"value":66}],"source":"https://doi.org/10.1200/jco.20.00147"}]},{"id":"nct06405490","kind":"trial","name":"NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC","aka":[],"tldr":"A phase 2 trial of cAPOX (capecitabine, oxaliplatin), capecitabine and cadonilimab in pancreatic cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC is a phase 2, interventional study registered as NCT06405490 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 30 participants, started 2024-04-17 and due to reach its primary completion in 2026-08-30. Interventions recorded: Nanoliposomal Irinotecan+Oxaliplatin +Capecitabine+Cadonilimab. Conditions listed: Nanoliposomal Irinotecan; Cadonilimab; Oxaliplatin; Capecitabine; First-Line; Advanced Cancer; Pancreatic Adenocarcinoma; Drug Use. Primary outcome: Objective Response Rate (ORR). Pancreatic eligibility wording from the registry: \"Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06405490","url":"https://clinicaltrials.gov/study/NCT06405490"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["capox","capecitabine","cadonilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06405490","phase":"2","setting":"Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in Combination With Cadonilimab for First-Line Treatment of Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2024-04-17","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"naliricc","kind":"trial","name":"NALIRICC (AIO)","aka":[],"tldr":"Adding a liposomal chemotherapy did not help in second-line bile duct cancer, contradicting an earlier Korean trial.","summary":"NALIRICC, run by the German AIO group and published in Lancet Gastroenterology and Hepatology in 2024, found that adding liposomal irinotecan to fluorouracil and leucovorin did not help in second-line biliary tract cancer after gemcitabine, contradicting the earlier positive Korean NIFTY trial. It was a phase 2 of 100 patients that showed no improvement in progression-free or overall survival, although a 2025 pooled analysis of the two trials modestly favoured the combination. OnCo links it to biliary tract cancer and cytotoxic chemotherapy, and notes that second-line FOLFOX, per ABC-06, gives a small benefit. Whether the discordance between the two trials reflects population differences or chance is the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"Lancet Gastroenterol Hepatol 2024","url":"https://www.thelancet.com/journals/langas/article/PIIS2468-1253(24)00119-5/fulltext"}],"tags":["failure","lesson:replication"],"related":[],"cancers":["cholangiocarcinoma","gallbladder","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["liposomal-irinotecan","fluorouracil","leucovorin"],"companies":["aio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-naliricc-lancet-gastroenterol-hepatol-2024"],"journals":[],"dependsOn":[],"notes":["Gallbladder cancer: NALIRICC (AIO, NCT03043547) enrolled biliary tract cancer including gallbladder carcinoma after gemcitabine-based therapy; it is the negative counterpart of NIFTY and the reason liposomal irinotecan remains an option rather than a standard in second line."],"nct":"NCT03043547","phase":"2","setting":"Second-line biliary tract cancer after gemcitabine: liposomal irinotecan + 5-FU/LV vs 5-FU/LV","sponsor":"AIO (Germany)","result":"OS 6.9 vs 8.2 months; not improved.","started":"2017-10-24","startedType":"actual","yearReported":2024,"enrolled":100,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","unit":"months","arms":[{"name":"nal-IRI + 5-FU/LV","value":6.9},{"name":"5-FU/LV","value":8.2}]}]},{"id":"nct06669078","kind":"trial","name":"NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX as Conversion Therapy of Locally Advanced Pancreatic Cancer","aka":["NALIRIFOX"],"tldr":"A phase 2 trial of fluorouracil (5-FU) in pancreatic cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, not yet recruiting.","summary":"NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX as Conversion Therapy of Locally Advanced Pancreatic Cancer is a phase 2, randomised interventional study registered as NCT06669078 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, with a registry enrolment figure of 120 participants, started 2024-10-30 and due to reach its primary completion in 2027-10-15. Interventions recorded: Nal-lRl+Oxaliplain+5- FU +PD 1; Nal-lRl+Oxaliplain+5- FU. Conditions listed: Locally Advanced Pancreatic Cancer. Primary outcome: 1 year OS rate. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confi rmed pancreatic cancer;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06669078","url":"https://clinicaltrials.gov/study/NCT06669078"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06669078","phase":"2","setting":"A Prospective, Open, Randomized Controlled, Multicenter, Exploratory Clinical Study of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally Advanced Pancreatic Cancer","sponsor":"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","started":"2024-10-30","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07309289","kind":"trial","name":"NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by Shanghai Zhongshan Hospital, now recruiting.","summary":"NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT07309289 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 144 participants, started 2025-07-01 and due to reach its primary completion in 2029-03-01. Interventions recorded: NALIRIFOX plus targeted therapy; FOLFOX plus targeted therapy. Conditions listed: Metastatic Colorectal Cancer (CRC). Primary outcome: 18 month PFS rate. Colorectal eligibility wording from the registry: \"* Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07309289","url":"https://clinicaltrials.gov/study/NCT07309289"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07309289","phase":"3","setting":"NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer: a Multicentre, Open-label, Randomised Trial","sponsor":"Shanghai Zhongshan Hospital","started":"2025-07-01","startedType":"actual","enrolled":144,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07595172","kind":"trial","name":"NALIRIFOX+Adebrelimab+PULSAR for Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by West China Hospital, now recruiting.","summary":"NALIRIFOX+Adebrelimab+PULSAR for Advanced Pancreatic Cancer is a phase 1/2, interventional study registered as NCT07595172 by West China Hospital, with a registry enrolment figure of 55 participants, started 2026-04 and due to reach its primary completion in 2028-08. Interventions recorded: NALIRIFOX+Adebrelimab; PULSAR. Conditions listed: Pancreatic Ductal Adenocarcinoma (PDAC); Locally Advanced and Metastatic Pancreatic Cancer. Primary outcome: Objective response rate (RECIST v1.1). Pancreatic eligibility wording from the registry: \"* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07595172","url":"https://clinicaltrials.gov/study/NCT07595172"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07595172","phase":"1/2","setting":"A Phase I/II Clinical Trial of NALIRIFOX Combined With Adebrelimab and PULSAR as First-Line Treatment for Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma","sponsor":"West China Hospital","started":"2026-04","startedType":"estimated","enrolled":55,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05201404","kind":"trial","name":"Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis","aka":["LIVERATION"],"tldr":"A phase 3 trial of Namodenoson in hepatocellular carcinoma, run by Can-Fite BioPharma, now recruiting.","summary":"Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis is a phase 3 interventional study registered as NCT05201404 by Can-Fite BioPharma, with 471 participants planned, started 2023-03-15 and due to reach its primary completion in 2026-02. Interventions recorded: Namodenoson and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05201404","url":"https://clinicaltrials.gov/study/NCT05201404"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["can-fite"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05201404","phase":"3","setting":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis","sponsor":"Can-Fite BioPharma","started":"2023-03-15","startedType":"actual","enrolled":471,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06387342","kind":"trial","name":"Namodenoson Treatment of Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of Namodenoson 25mg in pancreatic ductal adenocarcinoma, run by Can-Fite BioPharma, now recruiting.","summary":"Namodenoson Treatment of Advanced Pancreatic Cancer is a phase 2 interventional study registered as NCT06387342 by Can-Fite BioPharma, with 20 participants planned, started 2024-11-10 and due to reach its primary completion in 2026-07-15. Interventions recorded: Namodenoson 25mg.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06387342","url":"https://clinicaltrials.gov/study/NCT06387342"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["can-fite"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06387342","phase":"2","setting":"CF102-222PC: A Phase 2 Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma","sponsor":"Can-Fite BioPharma","started":"2024-11-10","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06961201","kind":"trial","name":"Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer in the Cache","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Changchun GeneScience Pharmaceutical Co., Ltd., not yet recruiting.","summary":"Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer in the Cachexia Phase is a phase 3, randomised interventional study registered as NCT06961201 by Changchun GeneScience Pharmaceutical Co., Ltd., with a registry enrolment figure of 94 participants, started 2025-05-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: Nano-crystalline Megestrol Acetate Oral Suspension; standard treatment. Conditions listed: Extensive-stage Small Cell Lung Cancer (ES-SCLC); The Pre-cachexia or Cachexia Patients Who Have Not Received Systemic Treatment and Are Not Eligible for Curative Therapy. Primary outcome: The proportion of subjects with improved appetite based on A/CS-12 assessment; The proportion of subjects with a relative increase in BMI from baseline. Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (according to the Veterans Administration Lung Study Group (VALG) staging system)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06961201","url":"https://clinicaltrials.gov/study/NCT06961201"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["changchun-genescience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06961201","phase":"3","setting":"A Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer (ES-SCLC) in the Cachexia Phase","sponsor":"Changchun GeneScience Pharmaceutical Co., Ltd.","started":"2025-05-01","startedType":"estimated","enrolled":94,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04789486","kind":"trial","name":"Nano-SMART: Nanoparticles With MR Guided SBRT in Centrally Located Lung Tumors and Pancreatic Cancer","aka":["Nano-SMART"],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Dana-Farber Cancer Institute, now recruiting.","summary":"Nano-SMART: Nanoparticles With MR Guided SBRT in Centrally Located Lung Tumors and Pancreatic Cancer is a phase 1/2, randomised interventional study registered as NCT04789486 by Dana-Farber Cancer Institute, with a registry enrolment figure of 100 participants, started 2021-05-27 and due to reach its primary completion in 2028-04-10. Interventions recorded: AGuIX; Radiotherapy. Conditions listed: Non-small Cell Lung Cancer; Advanced Pancreatic Adenocarcinoma; Unresectable Pancreatic Cancer; Ductal Adenocarcinoma of the Pancreas. Primary outcome: Maximum tolerated dose (MTD) Phase 1; Compare Local Control at 12 months of Maximum tolerated dose MTD - Phase 2. Pancreatic eligibility wording from the registry: \"OR Histologically or cytologically confirmed pancreatic ductal adenocarcinoma of the pancreatic head, body or tail\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04789486","url":"https://clinicaltrials.gov/study/NCT04789486"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04789486","phase":"1/2","setting":"Nano-SMART: An Adaptive Phase I-II Trial of AGuIX Gadolinium-based Nanoparticles With Stereotactic Magnetic Resonance-guided Adaptive Radiation Therapy for Centrally Located Lung Tumors and Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma","sponsor":"Dana-Farber Cancer Institute","started":"2021-05-27","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07150663","kind":"trial","name":"Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of Megestrol acetate in non-small-cell lung cancer, run by Changchun GeneScience Pharmaceutical Co., Ltd., now recruiting.","summary":"Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT07150663 by Changchun GeneScience Pharmaceutical Co., Ltd., with 134 participants planned, started 2025-08-20 and due to reach its primary completion in 2027-06-30. Interventions recorded: Nano-crystalline Megestrol Acetate Oral Suspension.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07150663","url":"https://clinicaltrials.gov/study/NCT07150663"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["cachexia-appetite-pharmacotherapy","endocrine-therapy"],"targets":[],"drugs":["megestrol"],"companies":["changchun-genescience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07150663","phase":"3","setting":"A Prospective, Randomized, Parallel-Controlled Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer","sponsor":"Changchun GeneScience Pharmaceutical Co., Ltd.","started":"2025-08-20","startedType":"actual","enrolled":134,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06405139","kind":"trial","name":"Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine As Conversion Therapy of Locally Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of capecitabine in colorectal cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine As Conversion Therapy of Locally Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT06405139 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 36 participants, started 2024-05-01 and due to reach its primary completion in 2026-04-30. Interventions recorded: Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine. Conditions listed: Colorectal Cancer. Primary outcome: Organ-sparing R0 Resection Rate. Colorectal eligibility wording from the registry: \"Patients with histopathological confirmed MSS/pMMR-type adenocarcinoma of the colon and upper rectum which is not amenable to radiotherapy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06405139","url":"https://clinicaltrials.gov/study/NCT06405139"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06405139","phase":"2","setting":"Phase II Study of Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine As Conversion Therapy for Patients with Locally Advanced Colorectal Cancer","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2024-05-01","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"napoli-3","kind":"trial","name":"NAPOLI 3","aka":[],"tldr":"The first head-to-head trial of the two chemotherapy backbones, won narrowly by the four-drug regimen.","summary":"NAPOLI 3, trial NCT04083235 sponsored by Ipsen and reported in 2023, was the first head-to-head trial of the two chemotherapy backbones for first-line metastatic pancreatic cancer, comparing NALIRIFOX, the four-drug regimen built on liposomal irinotecan, with gemcitabine plus nab-paclitaxel. It randomised 770 patients and met its primary overall survival endpoint, with a narrow but statistically significant advantage and a clearer gain in progression-free survival, leading to FDA approval of NALIRIFOX in February 2024. OnCo links it to pancreatic ductal adenocarcinoma, to NALIRIFOX and gemcitabine plus nab-paclitaxel, to Zev A. Wainberg, and to the bottleneck of cold tumours; the result is consistent in direction with PRODIGE 4 for FOLFIRINOX. Critics note the absence of a modified FOLFIRINOX arm, so whether the new regimen beats the older four-drug standard is the open question.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT04083235","url":"https://clinicaltrials.gov/study/NCT04083235"},{"label":"Wainberg et al., NAPOLI 3 (Lancet 2023)","url":"https://doi.org/10.1016/S0140-6736(23)01366-1"},{"label":"Onivyde label (openFDA): NAPOLI 3 results table","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ONIVYDE%22"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["nalirifox","gemcitabine-nab-paclitaxel"],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":[],"trials":["prodige-4-accord-11","napoli-1","mpact","canstem111p"],"people":["zev-wainberg"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Design (Lancet 2023): 770 patients at 187 sites in 18 countries randomised between February 2020 and August 2021 to NALIRIFOX (liposomal irinotecan 50 mg/m2, oxaliplatin 60 mg/m2, leucovorin 400 mg/m2, fluorouracil 2,400 mg/m2 over 46 hours, days 1 and 15 of 28) or nab-paclitaxel 125 mg/m2 with gemcitabine 1,000 mg/m2 on days 1, 8 and 15. Median follow-up 16.1 months. Label figures (Onivyde, openFDA): overall survival 11.1 against 9.2 months (hazard ratio 0.84, 0.71 to 0.99; p 0.0403), progression-free survival 7.4 against 5.6 months (hazard ratio 0.70; p 0.0001), response 41.8 against 36.2 percent (not significant). Grade 3 or worse treatment-emergent adverse events 87 against 86 percent; treatment-related deaths 6 (2 percent) against 8 (2 percent). FDA approval of the regimen 13 February 2024; EU indication listed on the Onivyde product page; NICE appraisal TA1052 terminated on 2 April 2025 without a company submission.","UK sites (registry, 6): Guy's and St Thomas' NHS Foundation Trust; Royal Marsden (two entries); Imperial College Healthcare; the Christie; Nottingham City Hospital."],"nct":"NCT04083235","phase":"3","setting":"First-line metastatic PDAC: NALIRIFOX vs gemcitabine + nab-paclitaxel","sponsor":"Ipsen","result":"OS HR 0.84; PFS HR 0.69.","started":"2020-02-11","startedType":"actual","yearReported":2023,"enrolled":770,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"NALIRIFOX","n":383,"value":11.1},{"name":"Gemcitabine + nab-paclitaxel","n":387,"value":9.2}],"hr":0.83,"ci":[0.7,0.99],"p":"0.036","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01366-1/fulltext"}],"replication":"Consistent in direction with PRODIGE 4/ACCORD 11 (FOLFIRINOX vs gemcitabine); no direct FOLFIRINOX comparison."},{"id":"napoli-1","kind":"trial","name":"NAPOLI-1","aka":["NAPOLI 1","MM-398 phase 3"],"tldr":"NAPOLI-1 gave pancreatic cancer its first licensed second-line treatment: liposomal irinotecan with fluorouracil extended median survival from 4.2 to 6.1 months after gemcitabine had failed, while the liposome alone did nothing. It is approved in the United States and Europe but NICE turned it down in 2017.","summary":"NAPOLI-1 randomised 417 patients between January 2012 and September 2013: 117 to nanoliposomal irinotecan 80 mg/m2 with fluorouracil and folinic acid every two weeks (an arm added by amendment), 151 to nanoliposomal irinotecan 120 mg/m2 alone every three weeks and 149 to fluorouracil and folinic acid. Median overall survival was 6.1 months (95 percent confidence interval 4.8 to 8.9) with the combination against 4.2 months (3.3 to 5.3) with fluorouracil and folinic acid (hazard ratio 0.67, 0.49 to 0.92; p 0.012), while monotherapy gave 4.9 months (hazard ratio 0.99). Grade 3 or 4 neutropenia occurred in 27 percent, diarrhoea 13 percent, vomiting 11 percent and fatigue 14 percent of the combination arm. Four UK sites took part (Liverpool, London, Manchester, Sutton). The FDA approved Onivyde with fluorouracil and leucovorin in October 2015 and the European Commission on 14 October 2016 (orphan designation 2011); NICE TA440 (26 April 2017) does not recommend it within its marketing authorisation, a position NG85 restates (1.9.9). The same liposomal irinotecan later formed the NALIRIFOX first-line regimen tested in NAPOLI 3.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01494506","url":"https://clinicaltrials.gov/study/NCT01494506"},{"label":"Wang-Gillam et al., NAPOLI-1 (Lancet 2016)","url":"https://doi.org/10.1016/S0140-6736(15)00986-1"},{"label":"Onivyde label (openFDA): NAPOLI-1 study section","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ONIVYDE%22"},{"label":"EMA Onivyde pegylated liposomal product page (marketing authorisation 14 October 2016)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal"},{"label":"NICE TA440 (26 April 2017): not recommended","url":"https://www.nice.org.uk/guidance/ta440"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["liposomal-irinotecan","fluorouracil","leucovorin"],"companies":["merrimack-pharmaceuticals","ipsen"],"institutions":[],"pathways":[],"terms":["pancreatic-cancer-uk-drug-access"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 4): Liverpool, London, Manchester and Sutton (facility names not given). England: NICE TA440 (26 April 2017) does not recommend pegylated liposomal irinotecan with fluorouracil and leucovorin after gemcitabine-based therapy."],"nct":"NCT01494506","phase":"3","setting":"Metastatic pancreatic ductal adenocarcinoma after gemcitabine-based therapy at 76 sites in 14 countries: nanoliposomal irinotecan with fluorouracil and folinic acid, nanoliposomal irinotecan alone, or fluorouracil and folinic acid, with overall survival as the primary endpoint","sponsor":"Merrimack Pharmaceuticals (now Ipsen)","result":"Median overall survival 6.1 months with nanoliposomal irinotecan plus fluorouracil and folinic acid against 4.2 months with fluorouracil and folinic acid (hazard ratio 0.67, 95 percent confidence interval 0.49 to 0.92; p 0.012); monotherapy 4.9 months (hazard ratio 0.99).","started":"2011-11","yearReported":2016,"enrolled":417,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nanoliposomal irinotecan + fluorouracil/folinic acid","n":117,"value":6.1,"note":"95% CI 4.8 to 8.9"},{"name":"Nanoliposomal irinotecan alone","n":151,"value":4.9,"note":"95% CI 4.2 to 5.6; HR 0.99 versus control"},{"name":"Fluorouracil/folinic acid","n":149,"value":4.2,"note":"95% CI 3.3 to 5.3"}],"hr":0.67,"ci":[0.49,0.92],"p":"0.012","source":"https://doi.org/10.1016/S0140-6736(15)00986-1"}]},{"id":"nct04005339","kind":"trial","name":"NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer","aka":["NAPOLI-2"],"tldr":"A phase 2 trial of fluorouracil, leucovorin and liposomal irinotecan in gallbladder cancer and other biliary tract cancers, run by Georgetown University, active and no longer recruiting.","summary":"NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer is a phase 2 interventional study registered as NCT04005339 by Georgetown University, with a registry enrolment figure of 48 participants, started 2019-07-29 and due to reach its primary completion in 2025-09-03. Interventions recorded: Nanoliposomal Irinotecan, Leucovorin, Fluorouracil. Conditions listed: Advanced Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: \"* Pathologically-confirmed biliary tract cancer (cholangiocarcinoma or gallbladder adenocarcinoma), unresectable or metastatic\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04005339","url":"https://clinicaltrials.gov/study/NCT04005339"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","leucovorin","liposomal-irinotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04005339","phase":"2","setting":"NAPOLI-2: Phase II Study of Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Previously Treated Advanced Biliary Tract Cancer","sponsor":"Georgetown University","started":"2019-07-29","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"natalee","kind":"trial","name":"NATALEE","aka":[],"tldr":"Extended CDK4/6 inhibitors to a broad group of early hormone-positive breast cancer patients, including node-negative.","summary":"NATALEE, trial NCT03701334 sponsored by Novartis and published in the New England Journal of Medicine in 2023, extended adjuvant CDK4/6 inhibitors to a broad group of stage II to III HR-positive, HER2-negative early breast cancer patients, including those with node-negative disease. It randomised 5,101 patients to three years of ribociclib plus a non-steroidal aromatase inhibitor or the aromatase inhibitor alone, met its primary invasive disease-free survival endpoint at three years with the benefit growing at four years, and led to approval in September 2024. OnCo links it to HR-positive breast cancer, ribociclib, Gabriel N. Hortobagyi, Dennis J. Slamon, the bottleneck of dormant cells and the monarchE and NATALEE papers. Whether three years of a costly drug is justified in lower-risk patients is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT03701334","url":"https://clinicaltrials.gov/study/NCT03701334"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["ribociclib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["gabriel-hortobagyi","dennis-slamon"],"bottlenecks":[],"keyPapers":["paper-natalee-nejm-2024","paper-natalee-jama-oncol-2025-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03701334","phase":"3","setting":"Adjuvant ribociclib 3 years + endocrine therapy in stage II-III HR+/HER2- breast cancer","sponsor":"Novartis","result":"iDFS HR 0.75.","started":"2018-12-07","startedType":"actual","yearReported":2023,"enrolled":5101,"enrolledBasis":"registry","outcomes":[{"endpoint":"Invasive disease-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Ribociclib + NSAI","n":2549,"value":90.4},{"name":"NSAI alone","n":2552,"value":87.1}],"hr":0.75,"ci":[0.62,0.91],"p":"0.003","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2305488"},{"endpoint":"Invasive disease-free survival at 4 years","unit":"%","arms":[{"name":"Ribociclib + NSAI","value":88.5},{"name":"NSAI alone","value":83.6}],"hr":0.715,"ci":[0.609,0.84],"source":"https://clinicaltrials.gov/study/NCT03701334"}],"replication":"Consistent with monarchE (abemaciclib) in a broader, lower-risk population; PALLAS and PENELOPE-B (palbociclib) were negative, so the effect is not a uniform class effect."},{"id":"national-lung-matrix-trial","kind":"trial","name":"National Lung Matrix Trial","aka":["NLMT","Lung Matrix","CRUK Stratified Medicine Programme 2"],"tldr":"The National Lung Matrix Trial was the United Kingdom's umbrella trial in lung cancer: thousands of patients were screened through the NHS and those with one of 22 rare genetic changes were offered a matching drug. Most cohorts did not clear the bar, which taught the field how hard single-target matching is outside the strongest drivers.","summary":"The National Lung Matrix Trial opened in 2015, led by Gary Middleton at the University of Birmingham and fed by Cancer Research UK's Stratified Medicine Programme 2, which sequenced tumours from patients across the NHS with a 28-gene panel. Patients with one of the trial's actionable alterations and non-small-cell lung cancer that had progressed after first-line therapy entered one of 22 cohorts, each pairing a genetic change with one of eight drugs supplied by AstraZeneca and Pfizer: palbociclib, crizotinib, selumetinib with docetaxel, capivasertib, osimertinib, durvalumab, vistusertib and AZD4547. Each cohort used a Bayesian adaptive design with pre-set thresholds for response or durable benefit, so cohorts could be closed early or expanded.\n\nThe trial's main report, in Nature in 2020, covered more than 5,000 patients screened and around 300 treated across 19 cohorts. Few cohorts met their thresholds. Signals appeared where the drug matched a strong driver, and the trial confirmed the general finding of NCI-MATCH and Lung-MAP that many rarer alterations, especially loss-of-function changes and amplifications, do not predict benefit from a single targeted drug. A high proportion of screened patients could not enter because their disease had worsened or they had died before a slot opened, which quantified how slow tissue-based national screening was.\n\nWhat it changed in Britain was infrastructure: it showed the NHS could run population-scale molecular screening feeding one trial, which fed directly into the design of DETERMINE and TARGET National, and it argued for combinations and for screening earlier in the disease. The trial's later cohorts, including ceralasertib with durvalumab in RAS-mutant and wild-type disease and mTORC1/2 inhibition in STK11-deficient cancers, were published in 2025 and 2026.","status":"completed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02664935","url":"https://clinicaltrials.gov/study/NCT02664935"},{"label":"Middleton et al., Nature 2020: the National Lung Matrix Trial of personalized therapy in lung cancer","url":"https://doi.org/10.1038/s41586-020-2481-8"}],"tags":[],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["cgp","kinase-inhibitors","cdk46-inhibitor","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["palbociclib","crizotinib","selumetinib","docetaxel","capivasertib","osimertinib","durvalumab","vistusertib"],"companies":["astrazeneca","pfizer"],"institutions":["birmingham-cancer-centre","cruk"],"pathways":[],"terms":["master-protocol","seamless-adaptive","basket-umbrella-platform"],"trials":[],"people":["gary-middleton","sanjay-popat"],"bottlenecks":["b-trial-design","b-trial-enrolment"],"keyPapers":["paper-middleton-nature"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02664935","phase":"2","setting":"Advanced non-small-cell lung cancer after first-line treatment, screened nationally through the Cancer Research UK Stratified Medicine Programme: 22 biomarker-defined cohorts of eight targeted drugs","sponsor":"University of Birmingham, funded by Cancer Research UK with drugs from AstraZeneca and Pfizer","result":"Most of the 22 biomarker-drug cohorts did not meet their pre-set efficacy thresholds; the trial demonstrated national molecular screening and the limits of single-agent matching.","started":"2015-05-13","startedType":"actual","yearReported":2020,"enrolledBasis":"registry","outcomes":[{"endpoint":"Median progression-free survival, palbociclib in KRAS-mutant NSCLC (cohort C6; PFS is the primary outcome for the palbociclib arm)","primary":true,"unit":"months","arms":[{"name":"Palbociclib, KRAS mutation without AKT activation (C6)","n":30,"value":5.3,"note":"Bayesian estimate with 95% credible interval; posterior probability above 0.99 of exceeding the 3-month target; durable clinical benefit in 12 of 30 (40%, 25-53). Data snapshot 30 November 2019"}],"ci":[3.8,7.9],"source":"https://doi.org/10.1038/s41586-020-2481-8"},{"endpoint":"Screening funnel","unit":"patients","arms":[{"name":"Screened","value":5467},{"name":"Molecularly eligible","value":2007},{"name":"Entered the trial for genotype-matched therapy","value":302,"note":"Including 14 re-registered for a sequential drug; 276 analysable for the primary outcomes"}],"source":"https://doi.org/10.1038/s41586-020-2481-8"}]},{"id":"national-polyp-study","kind":"trial","name":"National Polyp Study","aka":["NPS"],"tldr":"The study that showed removing a polyp at colonoscopy does not just prevent cancer, it prevents death from it: half as many deaths as expected, fifteen years on.","summary":"The National Polyp Study followed 2,602 patients whose adenomas had been removed at colonoscopy. After a median 15.8 years, 1,246 had died of any cause and 12 of colorectal cancer, against 25.4 deaths expected from Surveillance, Epidemiology and End Results rates: a standardised incidence-based mortality ratio of 0.47 (95% CI 0.26 to 0.80), a 53 percent reduction. Mortality from colorectal cancer in the first ten years after polypectomy was the same as in the internal control group of people with non-adenomatous polyps. The study is the evidence that the adenoma-carcinoma sequence can be interrupted mechanically, which is the whole basis of colonoscopic screening and of the surveillance intervals that follow polypectomy.","status":"positive","asOf":"2026-09-24","links":[{"label":"National Polyp Study: colonoscopic polypectomy and long-term prevention of colorectal cancer deaths (New England Journal of Medicine 2012)","url":"https://doi.org/10.1056/NEJMoa1100370"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":["early-detection","prevention"],"technologies":["colorectal-screening","endoscopic-resection"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nordicc","minnesota-fob"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"observational","setting":"People whose adenomas were removed at colonoscopy: long-term colorectal cancer mortality against the general population and against people with non-adenomatous polyps","sponsor":"National Cancer Institute (US)","result":"Standardised incidence-based mortality ratio 0.47 (95% CI 0.26 to 0.80) after polypectomy, a 53 percent reduction in deaths from colorectal cancer.","yearReported":2012,"enrolled":2602,"enrolledBasis":"analysed","enrolledNote":"2,602 patients who had adenomas removed during the randomised surveillance study were followed for the long-term mortality analysis; the study began in 1980 and predates the registries.","outcomes":[{"endpoint":"Colorectal cancer mortality against the general population","primary":true,"unit":"standardised mortality ratio","arms":[{"name":"After colonoscopic polypectomy","n":2602,"value":0.47,"note":"12 observed against 25.4 expected deaths"}],"ci":[0.26,0.8],"source":"https://doi.org/10.1056/NEJMoa1100370"}],"replication":"NordICC, the first randomised trial of invitation to colonoscopy, found a smaller effect in intention-to-treat analysis because only 42 percent of those invited attended."},{"id":"navigate","kind":"trial","name":"NAVIGATE","aka":[],"tldr":"The basket trial behind the first tumour-agnostic TRK inhibitor approval: larotrectinib shrank tumours in three of four patients whatever the organ, as long as the cancer carried an NTRK gene fusion.","summary":"NAVIGATE, trial NCT02576431 sponsored by Bayer through Loxo Oncology, enrolled adults and children with TRK fusion-positive solid tumours of any type. Its early results were pooled with the adult phase 1 study and the paediatric SCOUT trial in the New England Journal of Medicine in 2018: 75% of the first 55 patients responded on independent review across 17 tumour types, and most responses were durable. The data supported the 2018 US accelerated approval of larotrectinib, the first treatment approved for a genomic marker regardless of tumour site, and the 2019 EU approval.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT02576431","url":"https://clinicaltrials.gov/study/NCT02576431"},{"label":"Drilon et al., Efficacy of larotrectinib in TRK fusion-positive cancers in adults and children (NEJM 2018)","url":"https://doi.org/10.1056/NEJMoa1714448"}],"tags":[],"related":[],"cancers":["metastatic-cancer","ntrk-fusion-nsclc"],"sections":[],"technologies":["cgp","kinase-inhibitors"],"targets":["ntrk"],"drugs":["larotrectinib"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-navigate-j-clin-invest-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02576431","phase":"2","setting":"TRK fusion-positive solid tumours in adults and children, any tumour type: larotrectinib single-arm basket trial","sponsor":"Bayer (Loxo Oncology)","result":"ORR 75% by independent review in the first 55 pooled patients across 17 tumour types.","started":"2015-09-30","startedType":"actual","yearReported":2018,"enrolled":215,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (independent review, pooled with LOXO-TRK-14001 and SCOUT)","primary":true,"unit":"%","arms":[{"name":"Larotrectinib","n":55,"value":75}],"source":"https://doi.org/10.1056/NEJMoa1714448"}]},{"id":"navigator","kind":"trial","name":"NAVIGATOR","aka":[],"tldr":"NAVIGATOR showed that avapritinib shrank almost every GIST driven by the PDGFRA D842V mutation, a type that had resisted every earlier drug, and won the drug its approval for that group.","summary":"NAVIGATOR was the first-in-human phase 1 study of avapritinib, a kinase inhibitor designed to bind the active conformation of KIT and PDGFRA and so to inhibit the D842V mutation that imatinib, sunitinib and regorafenib cannot. It enrolled patients with unresectable gastrointestinal stromal tumour in dose-escalation and expansion cohorts, including a cohort with PDGFRA D842V mutations and cohorts of KIT-mutant disease after prior kinase inhibitors.\n\nIn PDGFRA D842V-mutant GIST the response rate was very high and responses lasted for years, a transformation for a group with essentially no prior effective therapy, and avapritinib was approved in the United States in January 2020 for that indication. Activity in later-line KIT-mutant disease was more modest, and the confirmatory VOYAGER trial did not show superiority over regorafenib in that setting. Cognitive side effects and intracranial haemorrhage at higher doses were the notable toxicities.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02508532","url":"https://clinicaltrials.gov/study/NCT02508532"}],"tags":["subtype-trials"],"related":[],"cancers":["gist-pdgfra-d842v","gist","sarcoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["avapritinib"],"companies":["blueprint-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["michael-heinrich"],"bottlenecks":[],"keyPapers":["paper-navigator-avapritinib-heinrich-lancet-oncol-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02508532","phase":"1","setting":"Unresectable or metastatic gastrointestinal stromal tumour, including PDGFRA D842V-mutant disease and imatinib-resistant KIT-mutant disease: avapritinib dose escalation and expansion","sponsor":"Blueprint Medicines","result":"Very high, durable response rate in PDGFRA D842V-mutant GIST; approved for that indication in January 2020.","started":"2015-08","startedType":"actual","yearReported":2020,"enrolled":250,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response, PDGFRA D842V-mutant GIST (dose-expansion primary endpoint)","primary":true,"unit":"%","arms":[{"name":"Avapritinib","n":56,"value":88,"note":"95% CI 76 to 95; median follow-up 15.9 months"}],"source":"https://doi.org/10.1016/S1470-2045(20)30269-2"},{"endpoint":"Complete response, PDGFRA D842V-mutant GIST","unit":"%","arms":[{"name":"Avapritinib","n":56,"value":9}],"source":"https://doi.org/10.1016/S1470-2045(20)30269-2"},{"endpoint":"Treatment-related grade 3-4 adverse events","unit":"%","arms":[{"name":"Avapritinib","n":82,"value":57,"note":"Most common anaemia (17%); no treatment-related deaths"}],"source":"https://doi.org/10.1016/S1470-2045(20)30269-2"}]},{"id":"naxitamab-201","kind":"trial","name":"Naxitamab Study 201","aka":[],"tldr":"Study 201 was the single-arm phase 2 of 74 patients behind naxitamab's approval for relapsed or refractory high-risk neuroblastoma in bone or bone marrow: given with GM-CSF as an outpatient, the antibody produced responses in half of patients. Without a randomised comparison against dinutuximab, equal efficacy is unproven.","summary":"Naxitamab Study 201, trial NCT03363373 sponsored by Y-mAbs and reported in 2020 with the full cohort published in Nature Communications in 2025, was the pivotal single-arm study behind naxitamab's approval for relapsed or refractory high-risk neuroblastoma in bone or bone marrow. In 74 patients treated with naxitamab and GM-CSF the objective response rate was 50 percent, with complete responses in 38 percent at the interim analysis and durable responses, and the drug can be given as an outpatient. OnCo links it to paediatric neuroblastoma, naxitamab, Nai-Kong V. Cheung and the bottleneck of rare and paediatric cancers without markets. Without a randomised comparison against dinutuximab, whether naxitamab's outpatient convenience comes with equal efficacy is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03363373","url":"https://clinicaltrials.gov/study/NCT03363373"}],"tags":[],"related":[],"cancers":["neuroblastoma","neuroblastoma-high-risk"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["naxitamab"],"companies":["y-mabs"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["nai-kong-cheung"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03363373","phase":"2","setting":"Relapsed/refractory high-risk neuroblastoma in bone/bone marrow: naxitamab + GM-CSF","sponsor":"Y-mAbs","result":"ORR 50%.","started":"2018-04-03","startedType":"actual","yearReported":2020,"enrolled":74,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Naxitamab + GM-CSF","n":74,"value":50}],"source":"https://www.nature.com/articles/s41467-025-56619-x"}]},{"id":"nct06012695","kind":"trial","name":"NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma","aka":[],"tldr":"A phase 1/2 trial of Temozolomide in advanced solid tumours, run by Novelwise Pharmaceutical Corporation, now recruiting.","summary":"NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma is a phase 1/2 interventional study registered as NCT06012695 by Novelwise Pharmaceutical Corporation, with 79 participants planned, started 2023-08-11 and due to reach its primary completion in 2028-05-30. Interventions recorded: NBM-BMX Capsule, Temozolomide and Standard radiotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06012695","url":"https://clinicaltrials.gov/study/NCT06012695"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06012695","phase":"1/2","setting":"A Phase Ib/II, Open-label Study of NBM-BMX as Monotherapy or in Combination With Radiotherapy and Temozolomide in Subjects With Solid Tumors or Newly Diagnosed Glioblastoma","sponsor":"Novelwise Pharmaceutical Corporation","started":"2023-08-11","startedType":"actual","enrolled":79,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07224152","kind":"trial","name":"NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of JNJ-90301900 in lung cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer is a phase 1/2, interventional study registered as NCT07224152 by M.D. Anderson Cancer Center, with a registry enrolment figure of 40 participants, started 2026-03-27 and due to reach its primary completion in 2028-08-30. Interventions recorded: NBTXR3. Conditions listed: Locally-Advanced Non-Small Cell Lung Cancer. Primary outcome: Safety and Adverse Events (AEs). Lung eligibility wording from the registry: \"Biopsy proven stage I-III NSCLC\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07224152","url":"https://clinicaltrials.gov/study/NCT07224152"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["jnj-90301900"],"companies":["nanobiotix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07224152","phase":"1/2","setting":"NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer","sponsor":"M.D. Anderson Cancer Center","started":"2026-03-27","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06941857","kind":"trial","name":"NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of cAPOX (capecitabine, oxaliplatin), fOLFIRI (5-FU, leucovorin, irinotecan), leucovorin (folinic acid), fluorouracil (5-FU) and other drugs in pancreatic cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, now recruiting.","summary":"NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT06941857 by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, with a registry enrolment figure of 20 participants, started 2025-09-04 and due to reach its primary completion in 2028-12. Interventions recorded: Oxaliplatin; Irinotecan; Folinic Acid; 5-Fluorouracil (5-FU); NC410; Nivolumab; Ipilimumab. Conditions listed: Pancreatic Cancer. Primary outcome: Number of participants experiencing unexpected toxicities. Unexpected toxicities are toxicities related to the study drug required treatment discontinuation.. Pancreatic eligibility wording from the registry: \"* Metastatic histologically or cytologically confirmed pancreatic ductal adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06941857","url":"https://clinicaltrials.gov/study/NCT06941857"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["capox","folfiri","leucovorin","fluorouracil","nivolumab","ipilimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06941857","phase":"2","setting":"A Phase 2 Study of NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Treatment-naïve, Metastatic Pancreatic Cancer","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","started":"2025-09-04","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"pediatric-match","kind":"trial","name":"NCI-COG Pediatric MATCH (APEC1621)","aka":[],"tldr":"Pediatric MATCH was the first nationwide precision-medicine trial for children: every child with a relapsed solid tumour could have their tumour sequenced and, if a matching drug existed, join a trial arm for it. It proved the plumbing works, even though most single drugs given alone did little.","summary":"Histology-agnostic screening protocol run by NCI and COG at Children's Oncology Group sites from 2017. Tumours underwent targeted cancer-gene panel sequencing and limited immunohistochemistry; patients with a predefined actionable alteration were assigned to phase 2 arms (selumetinib, larotrectinib, ensartinib, vemurafenib, erdafitinib, tazemetostat, samotolisib, ulixertinib, palbociclib, olaparib, tipifarnib, ivosidenib, selpercatinib, among others). In the first 1,000 tumours screened, testing was completed for 94.7%, actionable alterations were found in 31.5%, and 28.4% of patients were assigned and 13.1% enrolled on a treatment arm (Parsons et al., JCO 2022). MAPK-pathway alterations were most frequent (11.2%). Most single-agent arms produced few objective responses; the selumetinib arm in MAPK-altered tumours had no responses in 20 treated patients (Eckstein et al., JCO 2022), while larotrectinib in NTRK-fusion tumours and selpercatinib in RET-altered tumours were active. Screening is closed and arms are completing follow-up. Lessons: molecular screening at relapse is feasible nationally; single-agent targeted therapy is rarely enough outside fusion drivers; combination arms and earlier-line testing are the next step.","status":"active","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03155620","url":"https://clinicaltrials.gov/study/NCT03155620"},{"label":"Parsons et al., JCO 2022 (screening results)","url":"https://doi.org/10.1200/JCO.21.02838"},{"label":"Eckstein et al., JCO 2022 (selumetinib arm)","url":"https://doi.org/10.1200/JCO.21.02840"},{"label":"NCI: Pediatric MATCH","url":"https://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/pediatric-match"}],"tags":["nci-coverage","paediatric","precision-medicine"],"related":[],"cancers":[],"sections":[],"technologies":["cgp","ngs-bioinformatics-software"],"targets":[],"drugs":["larotrectinib","selpercatinib","vemurafenib","erdafitinib","tazemetostat","palbociclib","olaparib","ivosidenib"],"companies":["childrens-oncology-group","itcc"],"institutions":["nci"],"pathways":[],"terms":["basket-umbrella-platform","race-for-children-act"],"trials":[],"people":[],"bottlenecks":["b-rare-cancers","b-trial-design"],"keyPapers":["paper-parsons-j-clin-oncol","paper-eckstein-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03155620","phase":"platform","setting":"Relapsed or refractory solid tumours, non-Hodgkin lymphomas and histiocytic disorders, age 1-21: tumour sequencing then assignment to one of a dozen single-agent targeted-therapy phase 2 arms","sponsor":"National Cancer Institute / Children's Oncology Group","result":"Actionable alteration in 31.5% of the first 1,000 tumours; 28.4% assigned and 13.1% enrolled on a treatment arm.","started":"2017-07-31","startedType":"actual","yearReported":2022,"enrolled":1377,"enrolledBasis":"registry","outcomes":[{"endpoint":"Actionable alteration detected (first 1,000 tumours)","primary":true,"unit":"%","arms":[{"name":"Screened tumours","n":1000,"value":31.5}],"source":"https://doi.org/10.1200/JCO.21.02838"},{"endpoint":"Enrolled on a treatment arm","unit":"%","arms":[{"name":"Screened patients","n":1000,"value":13.1}],"source":"https://doi.org/10.1200/JCO.21.02838"}],"replication":"European counterparts (ESMART, run by ITCC, and the INFORM registry in Germany) reached similar conclusions about feasibility and about the weakness of single-agent targeting outside fusion drivers."},{"id":"nci-match","kind":"trial","name":"NCI-MATCH (EAY131)","aka":["NCI MATCH","Molecular Analysis for Therapy Choice","EAY131","MATCH trial"],"tldr":"NCI-MATCH was the largest trial to sequence tumours from thousands of patients across the United States and give each a drug matched to the mutation rather than to the organ. It proved the system could work at national scale, found real activity for a handful of matches, and showed that most single drugs given for a single mutation do little.","summary":"NCI-MATCH opened in August 2015, run by ECOG-ACRIN for the National Cancer Institute with Keith Flaherty and Peter O'Dwyer as chairs and every NCI cooperative group taking part. Patients whose cancer had progressed on standard therapy, or who had a rare cancer with no standard, had a fresh biopsy sequenced in one of four accredited laboratories with a common assay, and a central rules engine matched alterations to treatment arms, each a single-arm phase 2 with objective response as the endpoint. The trial started with ten arms and grew to nearly 40, testing drugs including dabrafenib with trametinib, nivolumab, trastuzumab emtansine, capivasertib, copanlisib, palbociclib, sunitinib, binimetinib, afatinib, osimertinib, crizotinib, larotrectinib and adavosertib.\n\nThe screening results, in the Journal of Clinical Oncology in 2020, described 5,954 patients: sequencing succeeded in the great majority, more than a third had an alteration the trial deemed actionable, and 17.8 percent were assigned to an arm. Rare and less common cancers made up most of the enrolment, which made NCI-MATCH one of the biggest sources of rare-tumour genomics. Among the arms, dabrafenib plus trametinib in BRAF V600-mutant non-melanoma cancers (response rate 38 percent) and nivolumab in mismatch repair-deficient non-colorectal cancers (36 percent) were clearly positive and supported later tumour-agnostic thinking; capivasertib in AKT1-mutant tumours and copanlisib in PIK3CA-mutant tumours showed moderate activity; most arms matching a drug to an amplification, a loss-of-function change or a rarer kinase mutation did not reach their bar. A 2023 Nature Medicine paper drew the lessons together, and a 2024 Clinical Cancer Research analysis showed that activity often depended on tumour type as much as on the mutation.\n\nWhat NCI-MATCH changed was infrastructure and expectations: a common national assay and rules engine, a precedent for enrolling rare cancers by mutation, and the recognition that genotype-only matching rarely suffices, which led directly to ComboMATCH (combinations chosen from preclinical evidence, opened 2023), myeloMATCH in leukaemia and the iMATCH immunotherapy programme. Its arms continue to be reported as follow-up matures.","status":"active","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02465060","url":"https://clinicaltrials.gov/study/NCT02465060"},{"label":"NCI: NCI-MATCH trial","url":"https://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match"},{"label":"Flaherty et al., Journal of Clinical Oncology 2020: molecular landscape and actionable alterations in NCI-MATCH","url":"https://doi.org/10.1200/JCO.19.03010"},{"label":"Salama et al., Journal of Clinical Oncology 2020: dabrafenib and trametinib in BRAF V600 tumours (arm H)","url":"https://doi.org/10.1200/JCO.20.00762"},{"label":"Azad et al., Journal of Clinical Oncology 2020: nivolumab in mismatch repair-deficient non-colorectal cancers (arm Z1D)","url":"https://doi.org/10.1200/JCO.19.00818"},{"label":"O'Dwyer et al., Nature Medicine 2023: the NCI-MATCH trial, lessons for precision oncology","url":"https://doi.org/10.1038/s41591-023-02379-4"},{"label":"Tumor-specific activity of precision medicines in the NCI-MATCH trial, Clinical Cancer Research 2024","url":"https://doi.org/10.1158/1078-0432.CCR-23-0983"}],"tags":["precision-medicine"],"related":[],"cancers":["rare-cancers"],"sections":[],"technologies":["cgp","ngs-bioinformatics-software","variant-knowledgebases","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["dabrafenib","trametinib","nivolumab","trastuzumab-emtansine","capivasertib","copanlisib","palbociclib","sunitinib","binimetinib","afatinib","osimertinib","crizotinib","larotrectinib","adavosertib"],"companies":["ecog-acrin"],"institutions":["nci","frederick-national-lab","md-anderson","mgh","yale-cancer-center"],"pathways":[],"terms":["master-protocol","basket-umbrella-platform","tumour-agnostic"],"trials":["combomatch","myelomatch","pediatric-match"],"people":["keith-flaherty","peter-odwyer"],"bottlenecks":["b-rare-cancers","b-trial-design"],"keyPapers":["paper-o-dwyer-nat-med","paper-zhou-clin-cancer-res","paper-azad-j-clin-oncol","paper-flaherty-j-clin-oncol","paper-salama-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02465060","phase":"platform","setting":"Advanced solid tumours, lymphomas and myeloma that have progressed on standard treatment: central tumour sequencing assigns patients to one of nearly 40 single-agent or doublet targeted-therapy arms by molecular alteration regardless of cancer type","sponsor":"National Cancer Institute and ECOG-ACRIN","result":"5,954 patients enrolled; 17.8 percent assigned to an arm. Dabrafenib plus trametinib in BRAF V600 tumours (38 percent response) and nivolumab in dMMR non-colorectal tumours (36 percent) were positive; most single-agent arms were not.","started":"2015-08-17","startedType":"actual","yearReported":2020,"enrolled":5954,"enrolledBasis":"registry","outcomes":[{"endpoint":"Assigned to a treatment arm","primary":false,"unit":"%","arms":[{"name":"Enrolled patients","n":5954,"value":17.8}],"source":"https://doi.org/10.1200/JCO.19.03010"},{"endpoint":"Objective response, dabrafenib plus trametinib in BRAF V600 tumours (arm H)","unit":"%","arms":[{"name":"Treated patients","value":38}],"source":"https://doi.org/10.1200/JCO.20.00762"},{"endpoint":"Objective response, nivolumab in dMMR non-colorectal tumours (arm Z1D)","unit":"%","arms":[{"name":"Treated patients","value":36}],"source":"https://doi.org/10.1200/JCO.19.00818"}]},{"id":"nci9673","kind":"trial","name":"NCI9673","aka":["NCI 9673","ETCTN 9673"],"tldr":"NCI9673 was the first completed immunotherapy trial in anal cancer: nivolumab on its own shrank tumours in a quarter of heavily treated patients, which made PD-1 blockade a standard later option, but the follow-on randomisation showed that adding ipilimumab did not help and added toxicity.","summary":"NCI9673 was a multi-institutional phase 2 trial of the NCI Experimental Therapeutics Clinical Trials Network. Part A gave nivolumab to 37 patients with previously treated metastatic anal squamous cell carcinoma; part B randomised further patients to nivolumab alone or nivolumab with ipilimumab, with progression-free survival as the primary endpoint.\n\nIn part A nine of 37 patients responded (24 percent), including two complete responses, with few grade 3 events and no serious adverse events, which established PD-1 blockade as an option after chemotherapy. In part B median progression-free survival was 2.9 months with nivolumab and 3.7 months with the combination (hazard ratio 0.86, p 0.25), response rates were similar (17.4 against 21.5 percent), and grade 3 or worse treatment-related adverse events doubled with ipilimumab (25 against 12 percent). The corpus's metastatic anal cancer page cites NCI9673 for nivolumab after chemotherapy.","status":"mixed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02314169","url":"https://clinicaltrials.gov/study/NCT02314169"}],"tags":["soc-trials"],"related":[],"cancers":["metastatic-anal-cancer","anal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":[],"institutions":["md-anderson"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nci9673-nivolumab-metastatic-anal-cancer-morris-lancet-oncol-2017","paper-nci9673-part-b-nivolumab-ipilimumab-anal-cancer-morris-jco-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02314169","phase":"2","setting":"Refractory metastatic squamous cell carcinoma of the anal canal after prior chemotherapy: single-arm nivolumab (part A), then a randomised comparison of nivolumab with or without ipilimumab (part B)","sponsor":"National Cancer Institute (NCI)","result":"Nivolumab alone: objective response 24 percent in 37 previously treated patients. Nivolumab with ipilimumab did not improve progression-free survival (3.7 against 2.9 months, hazard ratio 0.86) or response and doubled grade 3 or worse toxicity.","started":"2015-05-13","startedType":"actual","yearReported":2017,"enrolled":143,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate, part A","primary":true,"unit":"%","arms":[{"name":"Nivolumab","n":37,"value":24,"note":"95% CI 15 to 33; 2 complete and 7 partial responses"}],"source":"https://doi.org/10.1016/S1470-2045(17)30104-3"},{"endpoint":"Progression-free survival, part B","primary":true,"unit":"months","arms":[{"name":"Nivolumab + ipilimumab","value":3.7,"note":"90% CI 2.0 to 5.6"},{"name":"Nivolumab","value":2.9,"note":"90% CI 1.9 to 3.8"}],"hr":0.86,"ci":[0.6,1.23],"p":"0.25","source":"https://doi.org/10.1200/JCO-25-00929"},{"endpoint":"Objective response rate, part B","unit":"%","arms":[{"name":"Nivolumab + ipilimumab","value":21.5},{"name":"Nivolumab","value":17.4}],"p":"0.89","source":"https://doi.org/10.1200/JCO-25-00929"},{"endpoint":"Overall survival, part B","unit":"months","arms":[{"name":"Nivolumab + ipilimumab","value":20},{"name":"Nivolumab","value":15.9}],"hr":0.98,"source":"https://doi.org/10.1200/JCO-25-00929"},{"endpoint":"Grade 3 or worse treatment-related adverse events, part B","unit":"%","arms":[{"name":"Nivolumab + ipilimumab","value":25,"note":"12 patients"},{"name":"Nivolumab","value":12,"note":"6 patients"}],"source":"https://doi.org/10.1200/JCO-25-00929"}]},{"id":"co-17","kind":"trial","name":"NCIC CO.17","aka":["CO.17"],"tldr":"The trial that proved an EGFR antibody on its own lengthens life in bowel cancer, and whose stored tumour blocks then proved that only KRAS-normal tumours benefit.","summary":"CO.17 randomised 572 patients with pretreated EGFR-positive metastatic colorectal cancer to cetuximab with best supportive care or best supportive care alone. Cetuximab improved overall survival (hazard ratio for death 0.77, 95% CI 0.64 to 0.92, p=0.005) and progression-free survival (hazard ratio 0.68, 0.57 to 0.80) while preserving quality-of-life measures. Its lasting importance is the retrospective biomarker analysis of the trial's tumour blocks, published a year later, which found the survival benefit confined to KRAS wild-type tumours and absent, with a trend to harm, in KRAS-mutant ones: the first negative predictive biomarker in solid-tumour oncology and the reason RAS testing became mandatory before any EGFR antibody.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00079066","url":"https://clinicaltrials.gov/study/NCT00079066"},{"label":"CO.17: cetuximab for the treatment of colorectal cancer (New England Journal of Medicine 2007)","url":"https://doi.org/10.1056/NEJMoa071834"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["egfr","kras"],"drugs":["cetuximab"],"companies":["cctg"],"institutions":[],"pathways":[],"terms":[],"trials":["crystal-fire3","prime","opus"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00079066","phase":"3","setting":"Pretreated EGFR-positive metastatic colorectal cancer with no remaining standard option: cetuximab with best supportive care against best supportive care alone","sponsor":"NCIC Clinical Trials Group","result":"Overall survival hazard ratio 0.77 (95% CI 0.64 to 0.92, p=0.005) against best supportive care alone; benefit confined to KRAS wild-type tumours.","started":"2003-12-30","startedType":"actual","yearReported":2007,"enrolled":572,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"hazard ratio","arms":[{"name":"Cetuximab plus best supportive care","value":0.77},{"name":"Best supportive care","value":1}],"hr":0.77,"ci":[0.64,0.92],"p":"0.005","source":"https://doi.org/10.1056/NEJMoa071834"}],"replication":"PRIME extended the same logic prospectively to all of KRAS and NRAS."},{"id":"ma-20","kind":"trial","name":"NCIC MA.20","aka":[],"tldr":"MA.20, published alongside EORTC 22922, showed that adding nodal irradiation after lumpectomy improves disease-free survival, mainly by preventing distant spread, without a survival difference at ten years.","summary":"MA.20 randomised 1,832 women with node-positive or high-risk node-negative breast cancer treated by breast-conserving surgery and systemic therapy to whole-breast irradiation with or without regional nodal irradiation. Ten-year disease-free survival was 82.0 percent with nodal irradiation and 77.0 percent without (hazard ratio 0.76); overall survival did not differ (82.8 versus 81.8 percent), and lymphoedema and pneumonitis were more frequent (Whelan and colleagues, New England Journal of Medicine 2015).","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00005957","url":"https://clinicaltrials.gov/study/NCT00005957"},{"label":"NEJM 2015","url":"https://doi.org/10.1056/NEJMoa1415340"}],"tags":["radiation-wave4"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive","tnbc","breast-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["cctg"],"institutions":[],"pathways":[],"terms":["radiation-pneumonitis","post-mastectomy-radiotherapy"],"trials":["eortc-22922","supremo","nsabp-b51"],"people":[],"bottlenecks":[],"keyPapers":["paper-ma-20-n-engl-j-med-2015"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00005957","phase":"3","setting":"Node-positive or high-risk node-negative breast cancer after breast-conserving surgery: whole-breast irradiation with or without regional nodal irradiation","sponsor":"Canadian Cancer Trials Group","result":"10-year disease-free survival 82.0% vs 77.0% (hazard ratio 0.76); overall survival unchanged.","started":"2000-03-09","startedType":"actual","yearReported":2015,"enrolled":1832,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 10 years","primary":true,"unit":"%","arms":[{"name":"Whole breast plus nodal irradiation","n":916,"value":82},{"name":"Whole-breast irradiation alone","n":916,"value":77}]}]},{"id":"nct07765667","kind":"trial","name":"NCT + PD1 + Ketogenic Diet and/or Vitamin C for LARC","aka":[],"tldr":"A phase 2 trial of High-dose intravenous vitamin C in Rectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, not yet recruiting.","summary":"NCT + PD1 + Ketogenic Diet and/or Vitamin C for LARC is a phase 2 interventional study registered as NCT07765667 by Sixth Affiliated Hospital, Sun Yat-sen University, with 100 participants planned, started 2026-09-01 and due to reach its primary completion in 2029-09-01. Interventions recorded: Short-Course Radiotherapy, PD-1 monoclonal antibody, mFOLFOX6 regimen, Ketogenic Diet, Surgical resection, Vitamin C. Conditions recorded: Rectal Adenocarcinoma, High-Risk Cancer, MSS.\n\nLinked to the technology High-dose intravenous vitamin C because the registry's title names it (\"high dose intravenous vitamin c\") and Rectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07765667","url":"https://clinicaltrials.gov/study/NCT07765667"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["high-dose-vitamin-c"],"targets":[],"drugs":["folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07765667","phase":"2","setting":"Neoadjuvant Chemoradiotherapy and Immunotherapy Combined With Ketogenic Diet and/or High-Dose Intravenous Vitamin C in pMMR/MSS Locally Advanced Rectal Adenocarcinoma: A Prospective, Multicenter, Phase Ⅱ Clinical Study (CRI-KEV Trial)","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2026-09-01","startedType":"estimated","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07150416","kind":"trial","name":"Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study","aka":[],"tldr":"A phase 2 trial in lung cancer, run by The First Affiliated Hospital of Guangzhou Medical University, not yet recruiting.","summary":"Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study is a phase 2, interventional study registered as NCT07150416 by The First Affiliated Hospital of Guangzhou Medical University, with a registry enrolment figure of 38 participants, started 2025-10-01 and due to reach its primary completion in 2026-12-01. Interventions recorded: Recombinant Human Ad-p53 Injection. Conditions listed: Multiple Pulmonary Ground-Glass Nodules; Lung Neoplasms; Precancerous Conditions. Primary outcome: Objective Response Rate (ORR). Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07150416","url":"https://clinicaltrials.gov/study/NCT07150416"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07150416","phase":"2","setting":"A Single-Arm Clinical Study of Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection (Gendicine) for Treatment of Multiple Ground-Glass Lung Nodules","sponsor":"The First Affiliated Hospital of Guangzhou Medical University","started":"2025-10-01","startedType":"estimated","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06765109","kind":"trial","name":"Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","aka":["ALKAZAR"],"tldr":"A phase 3 trial of Neladalkib, Alectinib in non-small-cell lung cancer and small-cell lung cancer, run by Nuvalent Inc., now recruiting.","summary":"Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC is a phase 3 interventional study registered as NCT06765109 by Nuvalent Inc., with 450 participants planned, started 2025-07-17 and due to reach its primary completion in 2029-12. Interventions recorded: Neladalkib (NVL-655), Alectinib. Conditions listed: Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06765109","url":"https://clinicaltrials.gov/study/NCT06765109"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["neladalkib","alectinib"],"companies":["nuvalent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06765109","phase":"3","setting":"A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)","sponsor":"Nuvalent Inc.","started":"2025-07-17","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07306624","kind":"trial","name":"Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by STCube, Inc., now recruiting.","summary":"Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer is a phase 2 interventional study registered as NCT07306624 by STCube, Inc., with 62 participants planned, started 2026-01-10 and due to reach its primary completion in 2027-08-31. Interventions recorded: Nelmastobart and Docetaxel. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07306624","url":"https://clinicaltrials.gov/study/NCT07306624"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":["stcube"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07306624","phase":"2","setting":"A Multicenter, Phase 2 Clinical Trial Based on an Adaptive Design to Evaluate the Safety and Efficacy of Nelmastobart in Combination With Docetaxel in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Who Are Resistant or Intolerant to Platinum-based Chemotherapy and/or Immunotherapy","sponsor":"STCube, Inc.","started":"2026-01-10","startedType":"actual","enrolled":62,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06873763","kind":"trial","name":"Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of Trifluridine/tipiracil, Bevacizumab in colorectal cancer, run by STCube, Inc., now recruiting.","summary":"Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer is a phase 1/2 interventional study registered as NCT06873763 by STCube, Inc., with 52 participants planned, started 2025-06-09 and due to reach its primary completion in 2025-12. Interventions recorded: Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab. Conditions listed: Metastatic Colorectal Cancer (CRC), Recurrent Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06873763","url":"https://clinicaltrials.gov/study/NCT06873763"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["trifluridine-tipiracil","bevacizumab"],"companies":["stcube"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06873763","phase":"1/2","setting":"A Single-arm, Phase Ib/2 Study of Nelmastobart in Combination With Trifluridine/Tipiracil and Bevacizumab in Metastatic/Recurrent Colorectal Cancer Patients With Resistance or Intolerance to Oxaliplatin and Irinotecan-based Chemotherapy","sponsor":"STCube, Inc.","started":"2025-06-09","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01057069","kind":"trial","name":"Neo Adjuvant Chemotherapy in Triple Negative Breast Cancer","aka":["neo-TN"],"tldr":"A phase 2/3 trial of carboplatin, paclitaxel / nab-paclitaxel, doxorubicin, cyclophosphamide and other drugs in triple-negative breast cancer, run by The Netherlands Cancer Institute, active but no longer recruiting.","summary":"Neo Adjuvant Chemotherapy in Triple Negative Breast Cancer is a phase 2/3, randomised interventional study registered as NCT01057069 by The Netherlands Cancer Institute, with a registry enrolment figure of 310 participants, started 2010-01 and due to reach its primary completion in 2023-06. Interventions recorded: Carboplatin and Paclitaxel; Doxorubicin, cyclophosphamide; Doxorubicin, cyclophosphamide, carboplatin, thiotepa, cyclophosphamide. Conditions listed: Breast Cancer. Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01057069","url":"https://clinicaltrials.gov/study/NCT01057069"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","paclitaxel","doxorubicin","cyclophosphamide","thiotepa"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01057069","phase":"2/3","setting":"Randomized Phase II/III Study of Individualized Neoadjuvant Chemotherapy in ' Triple Negative' Breast Tumors","sponsor":"The Netherlands Cancer Institute","started":"2010-01","startedType":"actual","enrolled":310,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04109755","kind":"trial","name":"Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer","aka":["PEMREC"],"tldr":"A phase 2 trial of pembrolizumab in colorectal cancer, run by University Hospital, Geneva, now recruiting.","summary":"Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer is a phase 2, interventional study registered as NCT04109755 by University Hospital, Geneva, with a registry enrolment figure of 25 participants, started 2020-06-02 and due to reach its primary completion in 2022-06. Interventions recorded: Pembrolizumab. Conditions listed: Rectum Cancer; Rectal Cancer. Primary outcome: Tumour regression grade. Colorectal eligibility wording from the registry: \"* Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of rectal adenocarcinoma will be enrolled in this study\". Sites: Switzerland. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04109755","url":"https://clinicaltrials.gov/study/NCT04109755"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04109755","phase":"2","setting":"A Phase II Study to Evaluate Safety and Efficacy of Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer","sponsor":"University Hospital, Geneva","started":"2020-06-02","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06081244","kind":"trial","name":"NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)","aka":["ADAPT-TN-III"],"tldr":"A phase 3 trial of sacituzumab govitecan and pembrolizumab in triple-negative breast cancer, run by Women's Cancer Study Group GmbH, now recruiting.","summary":"NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III) is a phase 3, randomised interventional study registered as NCT06081244 by Women's Cancer Study Group GmbH, with a registry enrolment figure of 348 participants, started 2024-10-10 and due to reach its primary completion in 2029-09. Interventions recorded: Sacituzumab govitecan; Pembrolizumab. Conditions listed: Triple Negative Breast Cancer. Sites: Germany. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06081244","url":"https://clinicaltrials.gov/study/NCT06081244"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["sacituzumab-govitecan","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06081244","phase":"3","setting":"NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan Versus Sacituzumab Govitecan+Pembrolizumab in Low-risk, Triple-negative Early Breast Cancer (ADAPT-TN-III)","sponsor":"Women's Cancer Study Group GmbH","started":"2024-10-10","startedType":"actual","enrolled":348,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06846268","kind":"trial","name":"Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of ADG126 and pembrolizumab in colorectal cancer, run by National University Hospital, Singapore, now recruiting.","summary":"Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT06846268 by National University Hospital, Singapore, with a registry enrolment figure of 20 participants, started 2025-04-14 and due to reach its primary completion in 2027-12-31. Interventions recorded: ADG126; Pembrolizumab. Conditions listed: Locally Advanced Colorectal Cancer. Primary outcome: Rate of Major Pathologic Response (MPR). Colorectal eligibility wording from the registry: \"Histologically confirmed colorectal adenocarcinoma\". Sites: Singapore. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06846268","url":"https://clinicaltrials.gov/study/NCT06846268"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adg126","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06846268","phase":"2","setting":"Phase II Trial of Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer","sponsor":"National University Hospital, Singapore","started":"2025-04-14","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05116462","kind":"trial","name":"Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer","aka":["ORIENT-99"],"tldr":"A phase 3 trial of Pemetrexed, Carboplatin, Paclitaxel / nab-paclitaxel in non-small-cell lung cancer and small-cell lung cancer, run by Innovent Biologics (Suzhou) Co. Ltd., active and no longer recruiting.","summary":"Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer is a phase 3 interventional study registered as NCT05116462 by Innovent Biologics (Suzhou) Co. Ltd., with 506 participants enrolled, started 2024-03-15 and due to reach its primary completion in 2026-09-30. Interventions recorded: Pemetrexed, Carboplatin, Paclitaxel, Sintilimab, Cisplatin. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05116462","url":"https://clinicaltrials.gov/study/NCT05116462"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pemetrexed","carboplatin","paclitaxel","sintilimab","cisplatin"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05116462","phase":"3","setting":"A Randomized, Double-blind, Phase 3 Study of the Efficacy and Safety of Sindilizumab Combined With Chemotherapy or Placebo Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer (ORIENT-99)","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","started":"2024-03-15","startedType":"actual","enrolled":506,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05061550","kind":"trial","name":"Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer","aka":["NeoCOAST-2"],"tldr":"A phase 2 trial of Durvalumab, Oleclumab, Monalizumab in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, now recruiting.","summary":"Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT05061550 by AstraZeneca, with 630 participants planned, started 2022-04-14 and due to reach its primary completion in 2030-05-28. Interventions recorded: Durvalumab, Oleclumab, Monalizumab, Dato-DXd, AZD0171. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05061550","url":"https://clinicaltrials.gov/study/NCT05061550"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["durvalumab","oleclumab","monalizumab","datopotamab-deruxtecan","carboplatin","cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05061550-nat-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05061550","phase":"2","setting":"A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)","sponsor":"AstraZeneca","started":"2022-04-14","startedType":"actual","enrolled":630,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07743632","kind":"trial","name":"Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC","aka":["NeoASPECT"],"tldr":"A phase 2 trial of carboplatin, docetaxel, doxorubicin, cyclophosphamide and other drugs in triple-negative breast cancer, run by University of Kansas Medical Center, not yet recruiting.","summary":"Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC is a phase 2, interventional study registered as NCT07743632 by University of Kansas Medical Center, with a registry enrolment figure of 110 participants, started 2026-09 and due to reach its primary completion in 2032-12. Interventions recorded: Carboplatin; Docetaxel; Doxorubicin; Cyclophosphamide; Ivonescimab. Conditions listed: Breast Cancer; Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Histologically confirmed cT1c-T3 N0 or cT1-T3 N1-N2 triple-negative breast cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07743632","url":"https://clinicaltrials.gov/study/NCT07743632"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","docetaxel","doxorubicin","cyclophosphamide","ivonescimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07743632","phase":"2","setting":"Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC (NeoASPECT)","sponsor":"University of Kansas Medical Center","started":"2026-09","startedType":"estimated","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07824960","kind":"trial","name":"Neoadjuvant Avutometinib/Defactinib and mFOLFIRINOX Combination Therapy in Pancreatic Adenocarcinoma","aka":["Panc 004"],"tldr":"A phase 1/2 trial of avutometinib + defactinib in pancreatic cancer, run by University of Virginia, not yet recruiting.","summary":"Neoadjuvant Avutometinib/Defactinib and mFOLFIRINOX Combination Therapy in Pancreatic Adenocarcinoma is a phase 1/2, interventional study registered as NCT07824960 by University of Virginia, with a registry enrolment figure of 31 participants, started 2026-10-01 and due to reach its primary completion in 2029-04. Interventions recorded: Avutometinib (VS-6766) + Defactinib (VS-6063). Conditions listed: Pancreatic Cancer; PDAC - Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Carcinoma; Locally Advanced Pancreatic Cancer. Primary outcome: Dose limiting toxicities (DLTs) - Part A; Objective response (OR) - Part B. Pancreatic eligibility wording from the registry: \"Adenocarcinoma of the pancreas, confirmed by histology or cytology\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07824960","url":"https://clinicaltrials.gov/study/NCT07824960"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac","locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["avutometinib-defactinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07824960","phase":"1/2","setting":"Neoadjuvant Avutometinib/Defactinib and mFOLFIRINOX Combination Therapy in Pancreatic Adenocarcinoma: A Phase IB/II Safety and Efficacy Study","sponsor":"University of Virginia","started":"2026-10-01","startedType":"estimated","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07595874","kind":"trial","name":"Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3","aka":["NEST3"],"tldr":"A phase 2 trial of balstilimab and botensilimab in colorectal cancer, run by City of Hope Medical Center, now recruiting.","summary":"Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3 is a phase 2, interventional study registered as NCT07595874 by City of Hope Medical Center, with a registry enrolment figure of 100 participants, started 2026-12-27 and due to reach its primary completion in 2027-05-27. Interventions recorded: Balstilimab; Biospecimen Collection; Botensilimab; Computed Tomography; Magnetic Resonance Imaging. Conditions listed: Advanced Colon Adenocarcinoma; Advanced Colorectal Adenocarcinoma; Advanced Rectal Adenocarcinoma; Stage IIB Colon Cancer AJCC v8; Stage IIB Rectal Cancer AJCC v8; Stage IIC Colon Cancer AJCC v8; Stage IIC Rectal Cancer AJCC v8; Stage IIIA Colon Cancer AJCC v8; Stage IIIA Rectal Cancer AJCC v8; Stage IIIB Colon Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Colon Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8. Primary outcome: Two-year disease-free survival rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed or cytologically confirmed colorectal adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07595874","url":"https://clinicaltrials.gov/study/NCT07595874"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["balstilimab","botensilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07595874","phase":"2","setting":"A Phase II Novel Exploratory Study to Test Neoadjuvant Immunotherapy Combinations in Patients With Resectable Colon Cancer (NEST3)","sponsor":"City of Hope Medical Center","started":"2026-12-27","startedType":"estimated","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06790212","kind":"trial","name":"Neoadjuvant CAPOX Plus Ivonescimab Versus CAPOX for Locally Advanced Colon Cancer","aka":[],"tldr":"A phase 2 trial of ivonescimab, fOLFOX (5-FU, leucovorin, oxaliplatin) and capecitabine in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"Neoadjuvant CAPOX Plus Ivonescimab Versus CAPOX for Locally Advanced Colon Cancer is a phase 2, randomised interventional study registered as NCT06790212 by Sun Yat-sen University, with a registry enrolment figure of 168 participants, started 2025-04-28 and due to reach its primary completion in 2027-08-30. Interventions recorded: Ivonescimab; Oxaliplatin; Capecitabine. Conditions listed: Colon Cancer. Primary outcome: MPR rate. Colorectal eligibility wording from the registry: \"Histologically confirmed locally advanced resectable colon adenocarcinoma (colon cancer located more than 12 cm from the anal verge);\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06790212","url":"https://clinicaltrials.gov/study/NCT06790212"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["ivonescimab","folfox","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06790212","phase":"2","setting":"A Prospective, Randomized Phase II Study Evaluating CAPOX Combined with Ivonescimab (a PD-1/VEGF-A Bispecific Antibody) Versus CAPOX Alone As Neoadjuvant Therapy in Patients with Locally Advanced Colon Cancer.","sponsor":"Sun Yat-sen University","started":"2025-04-28","startedType":"estimated","enrolled":168,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07132008","kind":"trial","name":"Neoadjuvant CAPOX Plus Tislelizumab vs CAPOX in MSS High-Risk Locally Advanced Colon Cancer","aka":[],"tldr":"A phase 3 trial of tislelizumab, fOLFOX (5-FU, leucovorin, oxaliplatin) and capecitabine in colorectal cancer, run by First Affiliated Hospital of Guangxi Medical University, not yet recruiting.","summary":"Neoadjuvant CAPOX Plus Tislelizumab vs CAPOX in MSS High-Risk Locally Advanced Colon Cancer is a phase 3, randomised interventional study registered as NCT07132008 by First Affiliated Hospital of Guangxi Medical University, with a registry enrolment figure of 94 participants, started 2025-10-01 and due to reach its primary completion in 2027-09-30. Interventions recorded: Tislelizumab; Oxaliplatin; Capecitabine. Conditions listed: Colonic Neoplasms; Neoadjuvant Therapy; Immune Checkpoint Inhibitors. Primary outcome: Pathological complete response (pCR). Colorectal eligibility wording from the registry: \"* Pathologically diagnosed MSS ((confirmed by microsatellite stable detection or next-generation target sequencing) or (confirmed by immunohistochemistry)) colon adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07132008","url":"https://clinicaltrials.gov/study/NCT07132008"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["tislelizumab","folfox","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07132008","phase":"3","setting":"Prospective, Multicenter, Randomized Trial of Neoadjuvant Capecitabine and Oxaliplatin (CAPOX) Plus Tislelizumab Versus CAPOX in Microsatellite Stable High-risk Locally Advanced Colon Cancer","sponsor":"First Affiliated Hospital of Guangxi Medical University","started":"2025-10-01","startedType":"estimated","enrolled":94,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07528209","kind":"trial","name":"Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 3 trial of cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT07528209 by Sun Yat-sen University, with a registry enrolment figure of 556 participants, started 2026-04-20 and due to reach its primary completion in 2032-04-20. Interventions recorded: Pucotenlimab combine with CAPOX; CAPOX. Conditions listed: Rectal Cancer; pMMR (Microsatellite Stable Rectal Cancer). Primary outcome: 3-year disease-free survival (DFS) rate. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07528209","url":"https://clinicaltrials.gov/study/NCT07528209"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07528209","phase":"3","setting":"Neoadjuvant CAPOX Plus Pucotenlimab Combined With Selective Radiotherapy Versus CAPOX Combined With Selective Radiotherapy in Patients With Locally Advanced Rectal Cancer：A Multicenter, Phase III, Randomized Clinical Trial","sponsor":"Sun Yat-sen University","started":"2026-04-20","startedType":"estimated","enrolled":556,"enrolledBasis":"registry","outcomes":[]},{"id":"neoadjuvant-cemiplimab-cscc","kind":"trial","name":"Neoadjuvant cemiplimab for resectable stage II to IV skin squamous cell carcinoma","aka":["Gross neoadjuvant cemiplimab study","neoadjuvant cemiplimab in cutaneous squamous cell carcinoma"],"tldr":"Giving the immunotherapy before the operation left no living cancer cells in the removed specimen in half of the patients. For tumours that would otherwise cost someone an eye, an ear or part of the face, that changes what the operation has to take.","summary":"The large, deeply invasive cutaneous squamous cell carcinomas that arise on the face and scalp of older people are curable by surgery, but the surgery can be disfiguring or can cost an eye. This trial asked whether shrinking them first with a PD-1 antibody would change what had to be removed.\n\nSeventy-nine patients with resectable stage II to IV disease received up to four doses of cemiplimab 350 mg every three weeks and then went to surgery. The primary endpoint was a pathological complete response, meaning no viable tumour cells anywhere in the surgical specimen on independent central review, with a null hypothesis of 25 per cent.\n\nA pathological complete response was found in 40 of 79 patients (51 per cent, 95 per cent confidence interval 39 to 62) and a pathological major response, defined as viable tumour making up 10 per cent or less of the specimen, in a further 10 (13 per cent, 6 to 22). Almost two-thirds of the specimens therefore contained little or no living cancer. Imaging responses, at 68 per cent (57 to 78), understated the pathological result, which is the usual pattern with immunotherapy and is the reason the pathologist rather than the scanner decides this endpoint. Adverse events of any grade during the study occurred in 69 patients (87 per cent) and grade 3 or higher in 14 (18 per cent).\n\nWhat the trial does not yet answer is whether the surgery can be reduced, or omitted, on the strength of the response. It was designed with surgery for everybody, so the pathological complete responses were resected rather than watched. That is the next question, and it is the same question being asked after neoadjuvant immunotherapy in rectal and in bladder cancer.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04154943","url":"https://clinicaltrials.gov/study/NCT04154943"},{"label":"Primary report (New England Journal of Medicine 2022)","url":"https://doi.org/10.1056/NEJMoa2209813"},{"label":"Primary report on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/36094839/"}],"tags":[],"related":[],"cancers":["cutaneous-scc","advanced-cutaneous-scc","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["cemiplimab"],"companies":["regeneron","sanofi"],"institutions":[],"pathways":[],"terms":["pcr","irae","surgical-margins-keratinocyte-cancer"],"trials":["empower-cscc-1","c-post"],"people":[],"bottlenecks":[],"keyPapers":["paper-gross-neoadjuvant-cemiplimab-cscc-nejm-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04154943","phase":"2","setting":"Resectable stage II, III or IV (without distant metastases) cutaneous squamous cell carcinoma: up to four doses of cemiplimab 350 mg every three weeks before surgery with curative intent, with pathological complete response on independent central review as the primary endpoint against a null hypothesis of 25 per cent","sponsor":"Regeneron Pharmaceuticals and Sanofi","result":"Pathological complete response in 40 of 79 patients (51 per cent, 95 per cent confidence interval 39 to 62) and pathological major response in a further 13 per cent, with grade 3 or higher adverse events in 18 per cent.","started":"2020-03-10","startedType":"actual","yearReported":2022,"enrolled":79,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathological complete response on independent review","primary":true,"unit":"%","arms":[{"name":"Neoadjuvant cemiplimab, up to 4 doses","n":79,"value":51,"note":"40 of 79 patients; 95 per cent confidence interval 39 to 62"}],"source":"https://doi.org/10.1056/nejmoa2209813"},{"endpoint":"Pathological major response on independent review","unit":"%","arms":[{"name":"Neoadjuvant cemiplimab, up to 4 doses","n":79,"value":13,"note":"10 of 79 patients; 95 per cent confidence interval 6 to 22"}],"source":"https://doi.org/10.1056/nejmoa2209813"},{"endpoint":"Objective response on imaging","unit":"%","arms":[{"name":"Neoadjuvant cemiplimab, up to 4 doses","n":79,"value":68,"note":"54 of 79 patients; 95 per cent confidence interval 57 to 78"}],"source":"https://doi.org/10.1056/nejmoa2209813"}],"replication":"A pilot study of two doses of neoadjuvant cemiplimab produced the same high pathological complete response rate and is what this confirmatory phase 2 study was built to test."},{"id":"nct03916627","kind":"trial","name":"Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients","aka":[],"tldr":"A phase 2 trial of Cemiplimab, Fianlimab in non-small-cell lung cancer and small-cell lung cancer, run by Regeneron Pharmaceuticals, active and no longer recruiting.","summary":"Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients is a phase 2 interventional study registered as NCT03916627 by Regeneron Pharmaceuticals, with 65 participants enrolled, started 2019-07-23 and due to reach its primary completion in 2025-03-31. Interventions recorded: cemiplimab, Platinum Doublet, fianlimab. Conditions listed: Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03916627","url":"https://clinicaltrials.gov/study/NCT03916627"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","hcc","head-and-neck","hcc-early","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab","fianlimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03916627-lancet-gastroenterol-hepatol-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03916627","phase":"2","setting":"A Multi-Cohort Exploratory Study of Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC","sponsor":"Regeneron Pharmaceuticals","started":"2019-07-23","startedType":"actual","enrolled":65,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06449313","kind":"trial","name":"Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node or Other High Risk Features","aka":["NEO-SURG"],"tldr":"A phase 2 trial of cemiplimab in lung cancer, run by Georgetown University, now recruiting.","summary":"Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node or Other High Risk Features is a phase 2, interventional study registered as NCT06449313 by Georgetown University, with a registry enrolment figure of 21 participants, started 2026-08 and due to reach its primary completion in 2027-12. Interventions recorded: Cemiplimab-Rwlc. Conditions listed: Non-small Cell Lung Cancer Stage III. Primary outcome: Pathologic complete response (pCR) rate. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed stage 3 Non-Small Cell Lung Cancer (NSCLC) as assessed per the 8th American Joint Committee on Cancer (AJCC) that meets one of the below criteria:\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06449313","url":"https://clinicaltrials.gov/study/NCT06449313"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06449313","phase":"2","setting":"A Phase 2 Single-arm Study of Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement or Other High Risk Features","sponsor":"Georgetown University","started":"2026-08","startedType":"estimated","enrolled":21,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07134218","kind":"trial","name":"Neoadjuvant Chemoradiotherapy Combined With Immunotherapy and Anti-angiogenesis in Treating Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2/3 trial in colorectal cancer, run by Changhai Hospital, not yet recruiting.","summary":"Neoadjuvant Chemoradiotherapy Combined With Immunotherapy and Anti-angiogenesis in Treating Locally Advanced Rectal Cancer is a phase 2/3, randomised interventional study registered as NCT07134218 by Changhai Hospital, with a registry enrolment figure of 180 participants, started 2025-10 and due to reach its primary completion in 2027-10. Interventions recorded: serplulimab、bevacizumab; neoadjuvant chemoradiation therapy. Conditions listed: Rectal Cancer. Primary outcome: The rate of cCR. Colorectal eligibility wording from the registry: \"* Histologically confirmed rectal adenocarcinoma with immunohistochemistry results showing proficient mismatch repair (pMMR) or molecular testing results indicating microsatellite stability (MSS);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07134218","url":"https://clinicaltrials.gov/study/NCT07134218"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07134218","phase":"2/3","setting":"A National Multicenter, Prospective, Randomized Controlled Study of Serplulimab Injection Combined With Bevacizumab to Improve the Complete Response Rate of Neoadjuvant Therapy for Locally Advanced Stage Intermediate and Low Rectal Cancer","sponsor":"Changhai Hospital","started":"2025-10","startedType":"estimated","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05479240","kind":"trial","name":"Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of tislelizumab, capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Fujian Cancer Hospital, not yet recruiting.","summary":"Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT05479240 by Fujian Cancer Hospital, with a registry enrolment figure of 94 participants, started 2023-09-01 and due to reach its primary completion in 2025-06-01. Interventions recorded: Tislelizumab; Capecitabine; oxaliplatin; short-range radiotherapy. Conditions listed: Immunotherapy. Primary outcome: Pathological complete response rate. Colorectal eligibility wording from the registry: \"* Rectal adenocarcinoma confirmed by histopathology;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05479240","url":"https://clinicaltrials.gov/study/NCT05479240"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["tislelizumab","capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05479240","phase":"2","setting":"Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer--Randomized, Open, Multicenter Clinical Study","sponsor":"Fujian Cancer Hospital","started":"2023-09-01","startedType":"estimated","enrolled":94,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07132463","kind":"trial","name":"Neoadjuvant Chemoradiotherapy Followed by Chemotherapy With or Without Tislelizumab for Resectable Ultra-low Rectal Cancer: The RELIEVE-02 Study","aka":["RELIEVE-02"],"tldr":"A phase 3 trial in colorectal cancer, run by Fudan University, now recruiting.","summary":"Neoadjuvant Chemoradiotherapy Followed by Chemotherapy With or Without Tislelizumab for Resectable Ultra-low Rectal Cancer: The RELIEVE-02 Study is a phase 3, randomised interventional study registered as NCT07132463 by Fudan University, with a registry enrolment figure of 196 participants, started 2025-08-12 and due to reach its primary completion in 2027-12. Interventions recorded: Long-course chemoradiotherapy; Tislelizumab combined with the CAPOX regimen; CAPOX regimen. Conditions listed: Rectal Cancer. Primary outcome: Anus preservation rate. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07132463","url":"https://clinicaltrials.gov/study/NCT07132463"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07132463","phase":"3","setting":"A Multicenter, Randomized Controlled Clinical Study of Concurrent Chemoradiotherapy Followed by Chemotherapy With or Without Tislelizumab for Resectable Ultra-low Rectal Cancer: The RELIEVE-02 Study","sponsor":"Fudan University","started":"2025-08-12","startedType":"actual","enrolled":196,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05450029","kind":"trial","name":"Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer","aka":["SILAR"],"tldr":"A phase 2 trial of sintilimab in colorectal cancer, run by Yanhong Deng, now recruiting.","summary":"Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT05450029 by Yanhong Deng, with a registry enrolment figure of 51 participants, started 2022-01-01 and due to reach its primary completion in 2024-01-01. Interventions recorded: Sintilimab. Conditions listed: Rectal Cancer. Primary outcome: Pathological complete response. Colorectal eligibility wording from the registry: \"Treatment-naive patients with histological or cytological documentation of rectal adenocarcinoma (\\<12 cm from the anal verge)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05450029","url":"https://clinicaltrials.gov/study/NCT05450029"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05450029","phase":"2","setting":"Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer: A Single-Center, Open-Label, Single-Arm, Phase 2 Trial","sponsor":"Yanhong Deng","started":"2022-01-01","startedType":"actual","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07458529","kind":"trial","name":"Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer","aka":["NCRIT-PM9"],"tldr":"A phase 2 trial in colorectal cancer, run by Seventh Medical Center of PLA General Hospital, now recruiting.","summary":"Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT07458529 by Seventh Medical Center of PLA General Hospital, with a registry enrolment figure of 50 participants, started 2026-02-10 and due to reach its primary completion in 2027-05-05. Interventions recorded: CRT+PD-1 inhibitor+Probio-M9; CRT+PD-1 inhibitor+placebo. Conditions listed: Rectal Cancer, Adenocarcinoma; Neoadjuvant Therapy; Immunotherapy; Probio-M9; Tislelizumab; Randomized. Primary outcome: pCR rate. Colorectal eligibility wording from the registry: \"* Biopsy-proven rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07458529","url":"https://clinicaltrials.gov/study/NCT07458529"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07458529","phase":"2","setting":"Neoadjuvant Chemoradiotherapy Combined With Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: A Single-Center, Prospective, Randomized Controlled Trial (NCRIT-PM9 Trial)","sponsor":"Seventh Medical Center of PLA General Hospital","started":"2026-02-10","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06097416","kind":"trial","name":"Neoadjuvant Chemoradiotherapy Versus Total Neoadjuvant Therapy in the Treatment of T3 Rectal Cancer","aka":["NARCT"],"tldr":"A phase 3 trial in colorectal cancer, run by St. James's Hospital, Ireland, not yet recruiting.","summary":"Neoadjuvant Chemoradiotherapy Versus Total Neoadjuvant Therapy in the Treatment of T3 Rectal Cancer is a phase 3, randomised interventional study registered as NCT06097416 by St. James's Hospital, Ireland, with a registry enrolment figure of 100 participants, started 2024-10 and due to reach its primary completion in 2025-10. Interventions recorded: Neoadjuvant Chemoradiotherapy; Total Neoadjuvant Therapy. Conditions listed: Rectal Cancer. Primary outcome: Overall survival. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed surgically resectable adenocarcinoma of the rectum\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06097416","url":"https://clinicaltrials.gov/study/NCT06097416"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06097416","phase":"3","setting":"A Phase III, Multi-institutional Randomised Trial Comparing Neoadjuvant Chemoradiotherapy (NARCT) and Total Neoadjuvant Therapy (TNT) in Patients With T3 (a/b/c) Rectal Cancer","sponsor":"St. James's Hospital, Ireland","started":"2024-10","startedType":"estimated","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06647680","kind":"trial","name":"Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01）","aka":["CONTROL-01"],"tldr":"A phase 2 trial of capecitabine in colorectal cancer, run by The Affiliated Hospital of Qingdao University, now recruiting.","summary":"Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01） is a phase 2, interventional study registered as NCT06647680 by The Affiliated Hospital of Qingdao University, with a registry enrolment figure of 35 participants, started 2025-06-01 and due to reach its primary completion in 2026-12-01. Interventions recorded: Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles. Conditions listed: Rectal Cancer Patients. Primary outcome: Clinical complete response and pathological complete response. Colorectal eligibility wording from the registry: \"* Pathologically proven diagnosis of adenocarcinoma of the rectum\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06647680","url":"https://clinicaltrials.gov/study/NCT06647680"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06647680","phase":"2","setting":"Neoadjuvant Chemotherapy and Tislelizumab (PD-1 Inhibitior) for Locally Advanced Rectal Cancer: a Single-center, Prospective, Phase II Study","sponsor":"The Affiliated Hospital of Qingdao University","started":"2025-06-01","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07351487","kind":"trial","name":"Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for TNBC (NEOTORCH-BREAST07)","aka":["NEOTORCH-BREAST07"],"tldr":"A phase 2 trial of sintilimab and bevacizumab in triple-negative breast cancer, run by First Affiliated Hospital of Zhejiang University, now recruiting.","summary":"Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for TNBC (NEOTORCH-BREAST07) is a phase 2, interventional study registered as NCT07351487 by First Affiliated Hospital of Zhejiang University, with a registry enrolment figure of 37 participants, started 2025-09-25 and due to reach its primary completion in 2028-09-25. Interventions recorded: Neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab. Conditions listed: TNBC - Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Alternatively, if ER and PR expression is less than 10% and HER2 receptor is negative, it is also classified as TNBC;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07351487","url":"https://clinicaltrials.gov/study/NCT07351487"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sintilimab","bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07351487","phase":"2","setting":"Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for Triple Negative Breast Cancer:A Prospective, Single-Arm, Multicenter Clinical Study (NEOTORCII-BREASTO7)","sponsor":"First Affiliated Hospital of Zhejiang University","started":"2025-09-25","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06682195","kind":"trial","name":"Neoadjuvant Chemotherapy Combined With Toripalimab for TNBC (NEOTORCH-BREAST02)","aka":["NEOTORCH-BREAST02"],"tldr":"A phase 2 trial of toripalimab in triple-negative breast cancer, run by First Affiliated Hospital of Zhejiang University, now recruiting.","summary":"Neoadjuvant Chemotherapy Combined With Toripalimab for TNBC (NEOTORCH-BREAST02) is a phase 2, interventional study registered as NCT06682195 by First Affiliated Hospital of Zhejiang University, with a registry enrolment figure of 35 participants, started 2024-10-09 and due to reach its primary completion in 2026-10-01. Interventions recorded: Neoadjuvant chemotherapy combined with Toripalimab. Conditions listed: TNBC, Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"All patients had triple negative breast cancer confirmed by histopathology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06682195","url":"https://clinicaltrials.gov/study/NCT06682195"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06682195","phase":"2","setting":"Neoadjuvant Chemotherapy Combined With Toripalimab for Triple-negative Breast Cancer : a Prospective, Single-arm, Multi-center Study (NEOTORCH-BREAST02)","sponsor":"First Affiliated Hospital of Zhejiang University","started":"2024-10-09","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06107920","kind":"trial","name":"Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy","aka":["COnCERTO"],"tldr":"A phase 3 trial in colorectal cancer, run by University Hospital, Rouen, now recruiting.","summary":"Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy is a phase 3, randomised interventional study registered as NCT06107920 by University Hospital, Rouen, with a registry enrolment figure of 232 participants, started 2024-05-07 and due to reach its primary completion in 2031-08. Interventions recorded: Neoadjuvant chemotherapy. Conditions listed: Colon Cancer. Primary outcome: the success of a full curative therapeutic. Colorectal eligibility wording from the registry: \"* Patients with obstructive colon cancer treated by defunctioning stoma\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06107920","url":"https://clinicaltrials.gov/study/NCT06107920"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06107920","phase":"3","setting":"Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy : A Randomized Phase III Trial - COnCERTO (French 01-18)","sponsor":"University Hospital, Rouen","started":"2024-05-07","startedType":"actual","enrolled":232,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05268692","kind":"trial","name":"Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP","aka":[],"tldr":"A phase 2/3 trial of gemcitabine + nab-paclitaxel in pancreatic cancer, run by Kochi University, now recruiting.","summary":"Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP is a phase 2/3, randomised interventional study registered as NCT05268692 by Kochi University, with a registry enrolment figure of 500 participants, started 2019-01-01 and due to reach its primary completion in 2025-12-31. Interventions recorded: GS; GnP. Conditions listed: Pancreatic Adenocarcinoma. Primary outcome: overall survival. Pancreatic eligibility wording from the registry: \"elective pancreatectomy for pancreatic cancer\". Sites: Japan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05268692","url":"https://clinicaltrials.gov/study/NCT05268692"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05268692","phase":"2/3","setting":"Neoadjuvant Chemotherapy for Pancreatic Cancer; GS vs. GnP","sponsor":"Kochi University","started":"2019-01-01","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06368141","kind":"trial","name":"Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer","aka":["NeoCHIC"],"tldr":"A phase 2 trial of serplulimab, capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Ruijin Hospital, now recruiting.","summary":"Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer is a phase 2, interventional study registered as NCT06368141 by Ruijin Hospital, with a registry enrolment figure of 56 participants, started 2024-05-01 and due to reach its primary completion in 2026-02-28. Interventions recorded: Serplulimab; Capecitabine; Oxaliplatin. Conditions listed: Colon Cancer. Primary outcome: pathologic complete response. Colorectal eligibility wording from the registry: \"* Patients with histopathological confirmed primary colon adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06368141","url":"https://clinicaltrials.gov/study/NCT06368141"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["serplulimab","capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06368141","phase":"2","setting":"Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer","sponsor":"Ruijin Hospital","started":"2024-05-01","startedType":"actual","enrolled":56,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06225284","kind":"trial","name":"Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal Triple-negative Early Breast Cancer Patients","aka":["ESCALATE"],"tldr":"A phase 2 trial in triple-negative breast cancer, run by National Taiwan University Hospital, now recruiting.","summary":"Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal Triple-negative Early Breast Cancer Patients is a phase 2, randomised interventional study registered as NCT06225284 by National Taiwan University Hospital, with a registry enrolment figure of 124 participants, started 2024-08-22 and due to reach its primary completion in 2026-12. Interventions recorded: Goserelin Acetate 3.6mg、Goserelin Acetate 10.8mg、Leuprolide Acetate 3.75mg、Leuprorelin Acetate 22.5mg、Triptorelin pamoate 11.25mg、Triptorelin pamoate 22.5mg. Conditions listed: Triple Negative Breast Cancer; Premenopausal Breast Cancer. Triple-negative eligibility wording from the registry: \"Histological confirmed TNBC, as defined by the most recent ASCO/CAP guidelines\". Sites: Taiwan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06225284","url":"https://clinicaltrials.gov/study/NCT06225284"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06225284","phase":"2","setting":"A Randomized Phase II Study of Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal Triple-negative Early Breast Cancer Patients: ESCALATE Study","sponsor":"National Taiwan University Hospital","started":"2024-08-22","startedType":"actual","enrolled":124,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07365592","kind":"trial","name":"Neoadjuvant Chemotherapy, Anti-PD-1 Antibody and Sitagliptin for Locally Advanced pMMR CRC","aka":["Neo-CD"],"tldr":"A phase 1/2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) and capecitabine in colorectal cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"Neoadjuvant Chemotherapy, Anti-PD-1 Antibody and Sitagliptin for Locally Advanced pMMR CRC is a phase 1/2, randomised interventional study registered as NCT07365592 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 138 participants, started 2026-04-09 and due to reach its primary completion in 2029-12-01. Interventions recorded: Oxaliplatin; Capecitabine; Anti-PD-1 monoclonal antibody; Sitagliptin (DPP4 inhibitor). Conditions listed: Colorectal Cancer. Primary outcome: Adverse events (AEs); Dose limiting toxicities (DLTs); Proportion of patients achieving tumor regression grade 0/1 (TRG 0/1). Colorectal eligibility wording from the registry: \"* Pathologically diagnosed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07365592","url":"https://clinicaltrials.gov/study/NCT07365592"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07365592","phase":"1/2","setting":"A Phase Ib/II Study of Neoadjuvant Chemotherapy Combined With Anti-PD-1 Antibody and DPP4 Inhibitor Sitagliptin for Locally Advanced pMMR Colorectal Cancer","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2026-04-09","startedType":"actual","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06205485","kind":"trial","name":"Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer","aka":["NEO-RT"],"tldr":"A phase 3 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) and capecitabine in colorectal cancer, run by Canadian Cancer Trials Group, now recruiting.","summary":"Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer is a phase 3, randomised interventional study registered as NCT06205485 by Canadian Cancer Trials Group, with a registry enrolment figure of 250 participants, started 2024-06-26 and due to reach its primary completion in 2030-01-30. Interventions recorded: Leucovorin; Oxaliplatin; Fluoruracil; Capecitabine; Radiation. Conditions listed: Rectal Cancer. Primary outcome: Clinical response rate upon re-staging; Quality of Life defined using the LARS score. Colorectal eligibility wording from the registry: \"* Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient\". Sites: Canada, United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06205485","url":"https://clinicaltrials.gov/study/NCT06205485"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["folfox","capecitabine"],"companies":["cctg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06205485","phase":"3","setting":"A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation Versus Chemoradiotherapy For Early Rectal Cancer","sponsor":"Canadian Cancer Trials Group","started":"2024-06-26","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07016399","kind":"trial","name":"Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC","aka":[],"tldr":"A phase 2 trial of carboplatin, cyclophosphamide, darolutamide, doxorubicin and other drugs in triple-negative breast cancer, run by Vandana Abramson, now recruiting.","summary":"Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC is a phase 2, randomised interventional study registered as NCT07016399 by Vandana Abramson, with a registry enrolment figure of 51 participants, started 2025-09-09 and due to reach its primary completion in 2028-09-01. Interventions recorded: Biospecimen Collection; Breast Biopsy Procedure; Carboplatin; Cyclophosphamide; Darolutamide; Doxorubicin; Epirubicin; Magnetic Resonance Imaging; Paclitaxel; Pembrolizumab; Surgical Procedure; Ultrasound Imaging. Conditions listed: Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Triple-Negative Breast Carcinoma. Triple-negative eligibility wording from the registry: \"* Malignancies other than TNBC within 5 years prior to randomization, with the exception of those with a negligible risk of metastases or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07016399","url":"https://clinicaltrials.gov/study/NCT07016399"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","cyclophosphamide","darolutamide","doxorubicin","epirubicin","paclitaxel","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07016399","phase":"2","setting":"A Phase II Neoadjuvant Clinical Trial of the Androgen Receptor Inhibitor Darolutamide in Early-Stage Androgen Receptor Positive (AR+) Triple-Negative Breast Cancer","sponsor":"Vandana Abramson","started":"2025-09-09","startedType":"actual","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07015190","kind":"trial","name":"Neoadjuvant Darovasertib in Primary Uveal Melanoma","aka":["OptimUM-10"],"tldr":"A phase 3 trial testing Darovasertib in uveal melanoma, now recruiting.","summary":"Neoadjuvant Darovasertib in Primary Uveal Melanoma is a phase 3 interventional study registered as NCT07015190, led by IDEAYA Biosciences, and recruiting on the registry. Official title: A Randomised, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10). Planned enrolment is 520 participants (estimated). The study started in 2026-01-25 and primary completion is expected in 2030-10. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07015190","url":"https://clinicaltrials.gov/study/NCT07015190"}],"tags":["ctgov-ingest"],"related":[],"cancers":["uveal-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["darovasertib"],"companies":["ideaya-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07015190","phase":"3","setting":"A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)","sponsor":"IDEAYA Biosciences","started":"2026-01-25","startedType":"actual","enrolled":520,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07277322","kind":"trial","name":"Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases","aka":[],"tldr":"A phase 1/2 trial of toripalimab in colorectal cancer, run by Dan Feng, now recruiting.","summary":"Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases is a phase 1/2, interventional study registered as NCT07277322 by Dan Feng, with a registry enrolment figure of 24 participants, started 2026-09-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: Dupilumab; Toripalimab. Conditions listed: Metastatic Colorectal Cancer; Liver Metastases. Primary outcome: Number of dose limiting toxicities (DLTs). Colorectal eligibility wording from the registry: \"* Has not undergone a hysterectomy or bilateral oophorectomy; or\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07277322","url":"https://clinicaltrials.gov/study/NCT07277322"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":["coherus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07277322","phase":"1/2","setting":"Master Protocol for A Phase 1b/2 Study of Neoadjuvant Immunotherapy in Microsatellite Stable (MSS) Colorectal Cancer (CRC) Subjects With Resectable Liver Metastases","sponsor":"Dan Feng","started":"2026-09-01","startedType":"estimated","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06812728","kind":"trial","name":"Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients","aka":[],"tldr":"A phase 2 trial of fOLFIRINOX / mFOLFIRINOX and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Menoufia University, now recruiting.","summary":"Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients is a phase 2, randomised interventional study registered as NCT06812728 by Menoufia University, with a registry enrolment figure of 100 participants, started 2025-01-25 and due to reach its primary completion in 2027-01-25. Interventions recorded: mFOLFIRINOX; mFolfox6. Conditions listed: Rectum Cancer. Primary outcome: Complete clinical response rate. Colorectal eligibility wording from the registry: \"Histologically proven rectal adenocarcinoma\". Sites: Egypt. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06812728","url":"https://clinicaltrials.gov/study/NCT06812728"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfirinox","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06812728","phase":"2","setting":"Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy Versus Standard Total Neoadjuvant Approach for Locally Advanced Rectal Cancer Patients: a Randomized Controlled Phase 2 Trial.","sponsor":"Menoufia University","started":"2025-01-25","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05132504","kind":"trial","name":"Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of pembrolizumab and fOLFIRINOX / mFOLFIRINOX in pancreatic cancer, run by Baylor College of Medicine, now recruiting.","summary":"Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer is a phase 2, interventional study registered as NCT05132504 by Baylor College of Medicine, with a registry enrolment figure of 30 participants, started 2022-08-31 and due to reach its primary completion in 2027-05-21. Interventions recorded: Pembrolizumab; Folfirinox. Conditions listed: Pancreatic Ductal Adenocarcinoma. Primary outcome: Determine if the neoadjuvant FOLFIRINOX chemotherapy followed by pembrolizumab followed by surgery will improve the overall response rate (ORR) for patients with localized, resectable adenocarcinoma of the pancreas.. Pancreatic eligibility wording from the registry: \"Patient is ≥18 years of age and has histologically or cytologically confirmed localized adenocarcinoma of the pancreas that is potentially resectable\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05132504","url":"https://clinicaltrials.gov/study/NCT05132504"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["pembrolizumab","folfirinox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05132504","phase":"2","setting":"Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Pembrolizumab Followed by Surgery for Patients With Localized, Resectable Adenocarcinoma of the Pancreas","sponsor":"Baylor College of Medicine","started":"2022-08-31","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03426904","kind":"trial","name":"Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by Kyungpook National University Hospital, active but no longer recruiting.","summary":"Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer is a phase 3, randomised interventional study registered as NCT03426904 by Kyungpook National University Hospital, with a registry enrolment figure of 708 participants, started 2020-10-23 and due to reach its primary completion in 2028-12-28. Interventions recorded: Neoadjuvant FOLFOX; Conventional adjuvant FOLFOX. Conditions listed: Colon Cancer. Primary outcome: Relapse free survival after randomization. Colorectal eligibility wording from the registry: \"* Pathologically confirmed colon adenocarcinoma (\\> 15 cm from the anal verge)\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03426904","url":"https://clinicaltrials.gov/study/NCT03426904"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03426904","phase":"3","setting":"Neoadjuvant Chemotherapy for Non-metastatic Locally Advanced Colon Cancer: A Prospective Multicenter Randomized Controlled Trial","sponsor":"Kyungpook National University Hospital","started":"2020-10-23","startedType":"actual","enrolled":708,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07472868","kind":"trial","name":"Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk","aka":["MEND-IT II"],"tldr":"A phase 3 trial of FOLFOXIRI, cAPOX (capecitabine, oxaliplatin) and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by J. W. A. Burger, not yet recruiting.","summary":"Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT07472868 by J. W. A. Burger, with a registry enrolment figure of 394 participants, started 2026-03-03 and due to reach its primary completion in 2030-03-02. Interventions recorded: FOLFOXIRI; CAPOX; FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin); Chemoradiotherapy; Total mesorectal excision (+/- IORT); Watch-and-wait approach. Conditions listed: Locally Advanced Rectal Carcinoma. Primary outcome: Complete response. Colorectal eligibility wording from the registry: \"* Histopathological confirmed rectal cancer\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07472868","url":"https://clinicaltrials.gov/study/NCT07472868"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfoxiri","capox","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07472868","phase":"3","setting":"MEND-IT II: Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy, Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer.","sponsor":"J. W. A. Burger","started":"2026-03-03","startedType":"estimated","enrolled":394,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05201430","kind":"trial","name":"Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer","aka":["RCNAC"],"tldr":"A phase 3 trial of FOLFOXIRI and cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Fudan University, now recruiting.","summary":"Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT05201430 by Fudan University, with a registry enrolment figure of 300 participants, started 2021-08-27 and due to reach its primary completion in 2024-06. Interventions recorded: FOLFOXIRI; CapeOX. Conditions listed: Rectal Cancer. Primary outcome: 3-year disease free survival. Colorectal eligibility wording from the registry: \"* MRI evaluated of T3-4 or N+ rectal cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05201430","url":"https://clinicaltrials.gov/study/NCT05201430"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfoxiri","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05201430","phase":"3","setting":"Neoadjuvant FOLFOXIRI Chemotherapy Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer: An Open Label Randomized Controlled Phase III Trial","sponsor":"Fudan University","started":"2021-08-27","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05194878","kind":"trial","name":"Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers is a phase 3, randomised interventional study registered as NCT05194878 by Sun Yat-sen University, with a registry enrolment figure of 840 participants, started 2021-12-01 and due to reach its primary completion in 2024-12. Interventions recorded: neoadjuvant chemotherapyI; Colectomy; adjuvant chemotherapy. Conditions listed: Colon Cancer Stage II; Colon Cancer Stage III. Primary outcome: Disease-free survival. Colorectal eligibility wording from the registry: \"* Histologically proven adenocarcinoma or high grade dysplasia on histology plus unequivocal radiological evidence of invasive cancer of the colon(≥ 12 cm from the anal verge)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05194878","url":"https://clinicaltrials.gov/study/NCT05194878"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05194878","phase":"3","setting":"Phase III Study of Neoadjuvant FOLFOXIRI Chemotherapy Versus Immediate Surgery for High-risk Resectable Stage II and III Colon Cancers","sponsor":"Sun Yat-sen University","started":"2021-12-01","startedType":"actual","enrolled":840,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06443671","kind":"trial","name":"Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMR/MSS Locally Advanced Rectal Cancer","aka":["PKUCH-R09"],"tldr":"A phase 2/3 trial of cAPOX (capecitabine, oxaliplatin), fruquintinib and tislelizumab in colorectal cancer, run by Peking University Cancer Hospital & Institute, not yet recruiting.","summary":"Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMR/MSS Locally Advanced Rectal Cancer is a phase 2/3, randomised interventional study registered as NCT06443671 by Peking University Cancer Hospital & Institute, with a registry enrolment figure of 132 participants, started 2024-06-01 and due to reach its primary completion in 2026-06-01. Interventions recorded: CapeOX; Fruquintinib and Tislelizumab combined with mCapeOX. Conditions listed: Rectal Cancer. Primary outcome: Pathological complete response(pCR) rates. Colorectal eligibility wording from the registry: \"* Histologically confirmed rectal adenocarcinoma; Immunohistochemistry suggests pMMR, or PCR suggests MSS type patients;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06443671","url":"https://clinicaltrials.gov/study/NCT06443671"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","cytotoxic-chemotherapy","kinase-inhibitors","platinum"],"targets":[],"drugs":["capox","fruquintinib","tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06443671","phase":"2/3","setting":"Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Open-label, Multicenter, Randomized Controlled Trial","sponsor":"Peking University Cancer Hospital & Institute","started":"2024-06-01","startedType":"estimated","enrolled":132,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07691593","kind":"trial","name":"Neoadjuvant HRS-4642 Plus Chemotherapy With or Without Immunotherapy for Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Changhai Hospital, not yet recruiting.","summary":"Neoadjuvant HRS-4642 Plus Chemotherapy With or Without Immunotherapy for Pancreatic Cancer is a phase 2, interventional study registered as NCT07691593 by Changhai Hospital, with a registry enrolment figure of 60 participants, started 2026-06 and due to reach its primary completion in 2027-10. Interventions recorded: HRS-4642+NALIRIFOX; HRS-4642+NALIRIFOX+Adebrelimab; HRS-4642+NALIRIFOX+Adebrelimab. Conditions listed: Pancreatic Cancer. Primary outcome: Adverse events (AEs); Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1). Pancreatic eligibility wording from the registry: \"Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07691593","url":"https://clinicaltrials.gov/study/NCT07691593"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07691593","phase":"2","setting":"An Exploratory Clinical Study of HRS-4642 in Combination With Chemotherapy With or Without Adebrelimab as Neoadjuvant Therapy for Pancreatic Cancer","sponsor":"Changhai Hospital","started":"2026-06","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07403877","kind":"trial","name":"Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer","aka":["TORCH-OPTIMA"],"tldr":"A phase 2 trial of nivolumab and ipilimumab in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07403877 by Fudan University, with a registry enrolment figure of 114 participants, started 2026-02-01 and due to reach its primary completion in 2031-12-31. Interventions recorded: Nivolumab; Ipilimumab (1mg/kg); PULSAR; Radical surgery; Watch & wait. Conditions listed: Colorectal Cancer (MSI-H). Primary outcome: Complete regression (CR) rate. Colorectal eligibility wording from the registry: \"Histopathologically confirmed primary colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07403877","url":"https://clinicaltrials.gov/study/NCT07403877"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07403877","phase":"2","setting":"A Phase II Randomized Controlled Trial of Neoadjuvant Immunotherapy With or Without Radiotherapy in Locally Advanced Microsatellite Instability-High/Mismatch Repair-Deficient Colorectal Cancer","sponsor":"Fudan University","started":"2026-02-01","startedType":"estimated","enrolled":114,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07409844","kind":"trial","name":"Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer","aka":["RESET C2"],"tldr":"A phase 2 trial in colorectal cancer, run by Ismail Gögenur, not yet recruiting.","summary":"Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer is a phase 2, interventional study registered as NCT07409844 by Ismail Gögenur, with a registry enrolment figure of 152 participants, started 2026-03-01 and due to reach its primary completion in 2028-03-01. Interventions recorded: 1 Cycle of Pembrolizumab; 2 Cycles of Pembrolizumab; 3 Cycles of Pembrolizumab; Additional Cycle of Pembrolizumab. Conditions listed: DMMR Colorectal Cancer; Colon Cancer Stage I; Colon Cancer Stage II/III; Pembrolizumab; Immunotherapy. Primary outcome: Proportion of patients with clinical complete response (cCR). Colorectal eligibility wording from the registry: \"Clinical UICC stage I-III dMMR colon carcinoma\". Sites: Denmark. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07409844","url":"https://clinicaltrials.gov/study/NCT07409844"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07409844","phase":"2","setting":"Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer: A National, Multicentre, Personalised, Phase II Study (RESET C2)","sponsor":"Ismail Gögenur","started":"2026-03-01","startedType":"estimated","enrolled":152,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06734702","kind":"trial","name":"Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy for Locally Advanced Non-small Cell Lung Ca","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Sun Yat-sen University, now recruiting.","summary":"Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy for Locally Advanced Non-small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT06734702 by Sun Yat-sen University, with a registry enrolment figure of 497 participants, started 2024-11-30 and due to reach its primary completion in 2028-11-29. Interventions recorded: Neoadjuvant therapy; Hypo-RT and concurrent chemotherapy; CFRT and concurrent chemotherapy; Consolidative immunotherapy. Conditions listed: Neoadjuvant Therapy; Concurrent Chemoradiotherapy; Immunotherapy; Locally Advanced Non-Small Cell Lung Cancer. Primary outcome: Progression-Free Survival rate. Lung eligibility wording from the registry: \"* Diagnosis: Patients must have locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC), with histological or cytological confirmation of the diagnosis\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06734702","url":"https://clinicaltrials.gov/study/NCT06734702"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06734702","phase":"3","setting":"Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy Compared With Concurrent Chemoradiotherapy and Consolidative Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: A Randomized, Phase III Controlled Study","sponsor":"Sun Yat-sen University","started":"2024-11-30","startedType":"actual","enrolled":497,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06353997","kind":"trial","name":"Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC Patients","aka":[],"tldr":"A phase 2 trial of pembrolizumab and INBRX-106 in triple-negative breast cancer, run by Providence Health & Services, now recruiting.","summary":"Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC Patients is a phase 2, interventional study registered as NCT06353997 by Providence Health & Services, with a registry enrolment figure of 12 participants, started 2024-09-05 and due to reach its primary completion in 2027-06. Interventions recorded: Pembrolizumab; INBRX-106. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Patients must have histologically confirmed TNBC (ER/PR ≤ 10% allowed, HER2- as defined by ASCO guidelines)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06353997","url":"https://clinicaltrials.gov/study/NCT06353997"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","inbrx-106"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06353997","phase":"2","setting":"A Phase II, Single-arm, Multi-center, Open-label Study of Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as an Induction Immunotherapy for Stage II/III TNBC Patients","sponsor":"Providence Health & Services","started":"2024-09-05","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07549906","kind":"trial","name":"Neoadjuvant Iparomlimab/Tuvonralimab Plus CAPEOX Versus Iparomlimab/Tuvonralimab Plus CAPEOX and Propranolol for Locally Advanced pMMR Colon Cancer: A Prospecti","aka":[],"tldr":"A phase 2 trial of capecitabine, fOLFOX (5-FU, leucovorin, oxaliplatin) and propranolol (Hemangeol) in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"Neoadjuvant Iparomlimab/Tuvonralimab Plus CAPEOX Versus Iparomlimab/Tuvonralimab Plus CAPEOX and Propranolol for Locally Advanced pMMR Colon Cancer: A Prospective, Single-Center, Multi-Cohort Study is a phase 2, randomised interventional study registered as NCT07549906 by Sun Yat-sen University, with a registry enrolment figure of 45 participants, started 2026-04-20 and due to reach its primary completion in 2026-07-31. Interventions recorded: Iparomlimab/Tuvonralimab; Capecitabine; Oxaliplatin; Propranolol. Conditions listed: Colon Cancer (Stage II &Amp; III); Immunotherapy; Beta Blocker; Neoadjuvant Chemoimmunotherapy. Primary outcome: Major Pathological Response (MPR). Colorectal eligibility wording from the registry: \"Diagnosis / Stage: Histologically confirmed and radiologically assessed colon adenocarcinoma that is T4, or T3 with lymph node metastasis, with tumor location ≥10 cm from the anal verge, and clinical TNM staging per AJCC/UICC 8th edition\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07549906","url":"https://clinicaltrials.gov/study/NCT07549906"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["capecitabine","folfox","propranolol-hemangeol"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07549906","phase":"2","setting":"Neoadjuvant Iparomlimab/Tuvonralimab Plus CAPEOX Versus Iparomlimab/Tuvonralimab Plus CAPEOX and Propranolol for Locally Advanced pMMR Colon Cancer: A Prospective, Single-Center, Multi-Cohort Study","sponsor":"Sun Yat-sen University","started":"2026-04-20","startedType":"estimated","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02938299","kind":"trial","name":"Neoadjuvant L19IL2/L19TNF- Pivotal Study","aka":[],"tldr":"A phase 3 trial of L19IL2 + L19TNF in melanoma, run by Philogen S.p.A., active and no longer recruiting.","summary":"Neoadjuvant L19IL2/L19TNF- Pivotal Study is a phase 3 interventional study registered as NCT02938299 by Philogen S.p.A., with 214 participants enrolled, started 2016-07-01 and due to reach its primary completion in 2024-10. Interventions recorded: L19IL2 + L19TNF and Surgery.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02938299","url":"https://clinicaltrials.gov/study/NCT02938299"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","stage-iii-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["philogen-s-p-a"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02938299-ann-oncol-2025","paper-nct02938299-j-clin-oncol-2026-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02938299","phase":"3","setting":"A Pivotal Phase III, Open-label, Randomized, Controlled Multi-center Study of the Efficacy of L19IL2/L19TNF Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage III B/C Melanoma Patients","sponsor":"Philogen S.p.A.","started":"2016-07-01","startedType":"actual","enrolled":214,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05469022","kind":"trial","name":"Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Konkuk University Medical Center, now recruiting.","summary":"Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy is a phase 2, interventional study registered as NCT05469022 by Konkuk University Medical Center, with a registry enrolment figure of 40 participants, started 2022-05-19 and due to reach its primary completion in 2024-05-19. Interventions recorded: Neoadjuvant lazertinib. Conditions listed: Non Small Cell Lung Cancer. Primary outcome: Objective response rate. Lung eligibility wording from the registry: \"Patients with suspected lung cancer on chest CT findings\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05469022","url":"https://clinicaltrials.gov/study/NCT05469022"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["yuhan"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05469022","phase":"2","setting":"A Phase II, Single-Center, Single-Arm, Prospective Study of Neoadjuvant Lazertinib Therapy in Resectable EGFR-Mutation Positive Lung Adenocarcinoma Patients Detected by Broncho-alveolar Lavage Fluid(BALF) Liquid Biopsy","sponsor":"Konkuk University Medical Center","started":"2022-05-19","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05245474","kind":"trial","name":"Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer","aka":["POLARSTAR"],"tldr":"A phase 2 trial in colorectal cancer, run by Beijing Friendship Hospital, now recruiting.","summary":"Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT05245474 by Beijing Friendship Hospital, with a registry enrolment figure of 186 participants, started 2022-04-01 and due to reach its primary completion in 2024-03-01. Interventions recorded: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor). Conditions listed: Locally Advanced Rectal Cancer. Primary outcome: pCR rate. Colorectal eligibility wording from the registry: \"* biopsy diagnosed rectal adenocarcinoma, distal margin within 10cm to anal verge\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05245474","url":"https://clinicaltrials.gov/study/NCT05245474"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05245474","phase":"2","setting":"Efficacy and Safety of Neoadjuvant Long-course Chemoradiation Plus Tislelizumab in Mid-low Locally Advanced Rectal Cancer: a Phase II, Multi-center, Open-label, Randomized Controlled Trial (POLARSTAR Trial)","sponsor":"Beijing Friendship Hospital","started":"2022-04-01","startedType":"actual","enrolled":186,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07381400","kind":"trial","name":"Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)","aka":["FIRM02"],"tldr":"A phase 2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) and serplulimab in colorectal cancer, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, not yet recruiting.","summary":"Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study) is a phase 2, randomised interventional study registered as NCT07381400 by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, with a registry enrolment figure of 128 participants, started 2026-02-01 and due to reach its primary completion in 2028-02-01. Interventions recorded: mFOLFOX6; Serplulimab. Conditions listed: Rectal Cancer. Primary outcome: Pathological Complete Response Rate (pCR). Colorectal eligibility wording from the registry: \"Rectal cancer patients with MRI showing the lower edge of the tumor within 15 cm of the anal verge, cT3-4 N any or cT any N1/2;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07381400","url":"https://clinicaltrials.gov/study/NCT07381400"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07381400","phase":"2","setting":"A Multicenter, Randomized Controlled Clinical Study of Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)","sponsor":"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine","started":"2026-02-01","startedType":"estimated","enrolled":128,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04215731","kind":"trial","name":"Neoadjuvant mFOLFOXIRI Plus Bevacizumab in Patients With High-Risk Locally Advanced Rectal Cancer","aka":["FOBEAR"],"tldr":"A phase 3 trial in colorectal cancer, run by Yanhong Deng, now recruiting.","summary":"Neoadjuvant mFOLFOXIRI Plus Bevacizumab in Patients With High-Risk Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT04215731 by Yanhong Deng, with a registry enrolment figure of 582 participants, started 2020-03-27 and due to reach its primary completion in 2026-09-01. Interventions recorded: Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumab; Restaging; Concomitant Chemoradiotherapy; Surgery; Chemoradiotherapy (only when patients with MRF involved or ycT4a/b by restaging); Induction chemotherpay with FOLFOX. Conditions listed: Rectal Cancer. Primary outcome: Disease-free survival. Colorectal eligibility wording from the registry: \"Histological or cytological documentation of adenocarcinoma of the rectal (\\<12 cm from the anal verge)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04215731","url":"https://clinicaltrials.gov/study/NCT04215731"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04215731","phase":"3","setting":"Neoadjuvant mFOLFOXIRI Plus Bevacizumab Versus Induction FOLFOX Followed by Concomitant Chemoradiotherapy in Patients With High-Risk Locally Advanced Rectal Cancer: Multicenter Randomized Phase III Trial","sponsor":"Yanhong Deng","started":"2020-03-27","startedType":"actual","enrolled":582,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06599827","kind":"trial","name":"Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk LARC","aka":["iMHRT-LARC"],"tldr":"A phase 2 trial in colorectal cancer, run by Shanghai Zhongshan Hospital, not yet recruiting.","summary":"Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk LARC is a phase 2, interventional study registered as NCT06599827 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 54 participants, started 2024-09-20 and due to reach its primary completion in 2026-09-20. Interventions recorded: moderately hypofractionated radiotherapy; chemotherapy; immunotherapy; Total mesorectal excision (TME) surgery. Conditions listed: Rectal Cancer. Primary outcome: pathologic complete response (pCR). Colorectal eligibility wording from the registry: \"MRI-confirmed rectal adenocarcinoma with the lower edge of the lesion ≤10cm from the anal verge\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06599827","url":"https://clinicaltrials.gov/study/NCT06599827"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06599827","phase":"2","setting":"Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk PMMR/MSS Locally Advanced Rectal Cancer: a Prospective, Exploratory Phase II Trial（iMHRT-LARC）","sponsor":"Shanghai Zhongshan Hospital","started":"2024-09-20","startedType":"estimated","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07527520","kind":"trial","name":"Neoadjuvant Moderately Hypofractionated Radiotherapy Combined With Chemotherapy and Immunotherapy for High-risk pMMR/MSS Locally Advanced Rectal Cancer: A Prosp","aka":[],"tldr":"A phase 2 trial of serplulimab in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"Neoadjuvant Moderately Hypofractionated Radiotherapy Combined With Chemotherapy and Immunotherapy for High-risk pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Multi-center Randomized Control Phase II Trial is a phase 2, randomised interventional study registered as NCT07527520 by Fudan University, with a registry enrolment figure of 165 participants, started 2026-06 and due to reach its primary completion in 2028-07. Interventions recorded: Moderately Hypofractionated Radiotherapy; Serplulimab; CapOx+Long-course radiotherapy. Conditions listed: Rectal Cancer; Moderately Hypofractionated Radiotherapy; Serplulimab; pMMR/MSS. Primary outcome: Complete Remission (CR) Rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed colorectal adenocarcinoma with the lower margin of the lesion ≤ 10 cm from the anal verge as assessed by MRI, and immunohistochemistry confirming pMMR, or genetic testing demonstrating MSI-L or MSS\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07527520","url":"https://clinicaltrials.gov/study/NCT07527520"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07527520","phase":"2","setting":"Neoadjuvant Moderately Hypofractionated Radiotherapy Combined With Chemotherapy and Immunotherapy for High-risk pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Multi-center Randomized Control Phase II Trial","sponsor":"Fudan University","started":"2026-06","startedType":"estimated","enrolled":165,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07808151","kind":"trial","name":"Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer","aka":[],"tldr":"A phase 2 trial of pembrolizumab in colorectal cancer, run by Solstice Oncology, Inc., not yet recruiting.","summary":"Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer is a phase 2, randomised interventional study registered as NCT07808151 by Solstice Oncology, Inc., with a registry enrolment figure of 100 participants, started 2026-09-30 and due to reach its primary completion in 2029-09-30. Interventions recorded: Pembrolizumab; Porustobart. Conditions listed: Colon Cancer; Microsatellite Stable (MSS) Colon Cancer; Proficient Mismatch Repair (pMMR) Colon Cancer. Primary outcome: Major Pathologic Response (MPR) rate by Blinded Independent Pathologic Review (BIPR). Colorectal eligibility wording from the registry: \"Adenocarcinoma of the colon (rectosigmoid considered non-rectal); pMMR/MSS status\". Sites: Belgium, Italy, Netherlands, Spain, United Kingdom, United States. United Kingdom sites listed: 5. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07808151","url":"https://clinicaltrials.gov/study/NCT07808151"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Investigator Site (Aberdeen); Investigator Site (Cardiff); Investigator Site (Glasgow); Investigator Site (Leeds); Investigator Site (London)."],"nct":"NCT07808151","phase":"2","setting":"A Phase 2, Open-Label, Multicenter, Randomized Trial Evaluating the Efficacy and Safety of Different Schedules of Neoadjuvant Pembrolizumab and Porustobart in Patients With Resectable pMMR/MSS Colon Cancer","sponsor":"Solstice Oncology, Inc.","started":"2026-09-30","startedType":"estimated","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06646445","kind":"trial","name":"Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for dMMR/MSI-H Localized Colon Cancer: PREMICES Study.","aka":["PREMICES"],"tldr":"A phase 2 trial in colorectal cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group, not yet recruiting.","summary":"Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for dMMR/MSI-H Localized Colon Cancer: PREMICES Study. is a phase 2, randomised interventional study registered as NCT06646445 by GERCOR - Multidisciplinary Oncology Cooperative Group, with a registry enrolment figure of 60 participants, started 2025-09 and due to reach its primary completion in 2027-12. Interventions recorded: Pembrolizumab Injection [Keytruda]; Watch-and-wait approach; Surgery; Adjuvant chemotherapy. Conditions listed: Colon Cancer. Primary outcome: The rate of success of the experimental strategy at 6 months or after two successive colonoscopies (corresponding to timepoint at 6 months from the experimental strategy) following randomization.. Colorectal eligibility wording from the registry: \"Newly diagnosed, histologically confirmed colonic or upper third rectal adenocarcinoma, NB: material must be available from biopsy done during colonoscopy\". Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06646445","url":"https://clinicaltrials.gov/study/NCT06646445"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["gercor"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06646445","phase":"2","setting":"Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for Patients With Mismatch Repair-deficient or Microsatellite Instability-high (dMMR/MSI-H) Localized Colon Cancer: a Randomized GERCOR G-109 PRODIGE 84 PREMICES Phase II Trial","sponsor":"GERCOR - Multidisciplinary Oncology Cooperative Group","started":"2025-09","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06407310","kind":"trial","name":"Neoadjuvant Pembrolizumab, Carboplatin and Paclitaxel in Triple-negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of pembrolizumab, carboplatin and paclitaxel / nab-paclitaxel in triple-negative breast cancer, run by Tel Aviv Medical Center, not yet recruiting.","summary":"Neoadjuvant Pembrolizumab, Carboplatin and Paclitaxel in Triple-negative Breast Cancer is a phase 2, interventional study registered as NCT06407310 by Tel Aviv Medical Center, with a registry enrolment figure of 25 participants, started 2024-07-01 and due to reach its primary completion in 2027-04-01. Interventions recorded: Pembrolizumab; Carboplatin; Paclitaxel. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Male/female participants who are at least 18 years of age on the day of signing informed consent with a histologically confirmed diagnosis of stage I or II TNBC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06407310","url":"https://clinicaltrials.gov/study/NCT06407310"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pembrolizumab","carboplatin","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06407310","phase":"2","setting":"Phase II Open-label, Single-arm Trial of Neoadjuvant Pembrolizumab With Carboplatin and Paclitaxel in Triple-negative Breast Cancer","sponsor":"Tel Aviv Medical Center","started":"2024-07-01","startedType":"estimated","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07622771","kind":"trial","name":"Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial is a phase 2, randomised interventional study registered as NCT07622771 by Sun Yat-sen University, with a registry enrolment figure of 84 participants, started 2026-05-26 and due to reach its primary completion in 2028-06-30. Interventions recorded: Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX; Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX. Conditions listed: Rectal Cancers. Primary outcome: CR rate. Colorectal eligibility wording from the registry: \"Locally advanced rectal adenocarcinoma confirmed by histopathology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07622771","url":"https://clinicaltrials.gov/study/NCT07622771"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07622771","phase":"2","setting":"Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial","sponsor":"Sun Yat-sen University","started":"2026-05-26","startedType":"actual","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06850090","kind":"trial","name":"Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial","aka":[],"tldr":"A phase 3 trial of trifluridine/tipiracil and capecitabine in colorectal cancer, run by Shandong Cancer Hospital and Institute, now recruiting.","summary":"Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial is a phase 3, randomised interventional study registered as NCT06850090 by Shandong Cancer Hospital and Institute, with a registry enrolment figure of 210 participants, started 2025-07-30 and due to reach its primary completion in 2027-06. Interventions recorded: TAS-102; Capecitabine. Conditions listed: Rectal Cancer; Rectal Cancer Patients. Primary outcome: Complete response (CR) rate. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma with the following conditions:\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06850090","url":"https://clinicaltrials.gov/study/NCT06850090"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["trifluridine-tipiracil","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06850090","phase":"3","setting":"Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial","sponsor":"Shandong Cancer Hospital and Institute","started":"2025-07-30","startedType":"actual","enrolled":210,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06280495","kind":"trial","name":"Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients","aka":[],"tldr":"A phase 2/3 trial of fOLFOX (5-FU, leucovorin, oxaliplatin), fluorouracil (5-FU), serplulimab and bevacizumab (glioblastoma use) in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients is a phase 2/3, randomised interventional study registered as NCT06280495 by Sun Yat-sen University, with a registry enrolment figure of 156 participants, started 2024-02-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: Oxaliplatin; Fluorouracil; Serplulimab; Bevacizumab. Conditions listed: Colorectal Cancer; Liver Metastases. Primary outcome: 3-year Progression-Free Survival Rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06280495","url":"https://clinicaltrials.gov/study/NCT06280495"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","fluorouracil","serplulimab","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06280495","phase":"2/3","setting":"Neoadjuvant Combination of Serplulimab and Bevacizumab With FOLFOX Versus FOLFOX Alone for Resectable Liver Metastases in RAS/BRAF Wild-Type, pMMR/MSS Colorectal Cancer Patients","sponsor":"Sun Yat-sen University","started":"2024-02-01","startedType":"actual","enrolled":156,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07283692","kind":"trial","name":"Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)","aka":[],"tldr":"A phase 2 trial of serplulimab, paclitaxel / nab-paclitaxel and carboplatin in triple-negative breast cancer, run by RenJi Hospital, now recruiting.","summary":"Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT) is a phase 2, interventional study registered as NCT07283692 by RenJi Hospital, with a registry enrolment figure of 46 participants, started 2026-03-01 and due to reach its primary completion in 2026-12. Interventions recorded: Serplulimab; Paclitaxel; Carboplatin. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Histologically confirmed triple negative breast cancer (ER\\<10%, PR\\<10%, and HER2 negative)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07283692","url":"https://clinicaltrials.gov/study/NCT07283692"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["serplulimab","paclitaxel","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07283692","phase":"2","setting":"NEOadjuvant SERplulimab Plus Weekly PaclitaxEl and carboplatiN in Triple-negative Breast Cancer: a Prospective, Single-arm, Multicenter, Phase 2 Clinical Trial","sponsor":"RenJi Hospital","started":"2026-03-01","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07608159","kind":"trial","name":"Neoadjuvant SF-SBRT Plus Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC.","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Shanghai Pulmonary Hospital, Shanghai, China, not yet recruiting.","summary":"Neoadjuvant SF-SBRT Plus Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC. is a phase 3, randomised interventional study registered as NCT07608159 by Shanghai Pulmonary Hospital, Shanghai, China, with a registry enrolment figure of 201 participants, started 2026-05 and due to reach its primary completion in 2029-05. Interventions recorded: Stereotactic body radiotherapy (SBRT); neoadjuvant immunotherapy; Neoadjuvant Chemotherapy. Conditions listed: Non Small Cell Lung Cancer; Stereotactic Body Radiotherapy; Neoadjuvant Chemoimmunotherapy; Surgery. Primary outcome: 2-year event-free survival rate. Lung eligibility wording from the registry: \"* Previously untreated, pathologically confirmed, resectable or potentially -resectable stage II, IIIA, or IIIB (N2) non-small cell lung cancer according to the 8th edition of the American Joint Committee on Cancer staging system;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07608159","url":"https://clinicaltrials.gov/study/NCT07608159"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07608159","phase":"3","setting":"A Randomized, Controlled, Multicenter Phase III Clinical Study of Spatially Fractionated Stereotactic Body Radiotherapy Plus Toripalimab and Chemotherapy Versus Toripalimab Plus Chemotherapy in Patients With Resectable or Potentially Resectable Stage II-III Non-Small Cell Lung Cancer","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","started":"2026-05","startedType":"estimated","enrolled":201,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07509424","kind":"trial","name":"Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Locally Advanced HER2-expressing Rectal Ca","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, not yet recruiting.","summary":"Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Locally Advanced HER2-expressing Rectal Cance is a phase 2, interventional study registered as NCT07509424 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 29 participants, started 2026-04-22 and due to reach its primary completion in 2029-04-10. Interventions recorded: disitamab vedotin, sintilimab, capecitabine. Conditions listed: Rectal Cancer. Primary outcome: Complete response (CR) rate. Colorectal eligibility wording from the registry: \"Subjects are diagnosed with locally advanced rectal cancer by histology and/or cytology, with the lower edge of the tumor ≤10 cm from the anal verge\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07509424","url":"https://clinicaltrials.gov/study/NCT07509424"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","her2-amplified-colorectal"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07509424","phase":"2","setting":"Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Locally Advanced HER2-expressing Rectal Cance: Preliminary Results of a Prospective, Single-arm, Phase II Study.","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2026-04-22","startedType":"estimated","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06718543","kind":"trial","name":"Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer","aka":["TRIUNITE-03"],"tldr":"A phase 2 trial of ivonescimab and cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by fan li, now recruiting.","summary":"Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT06718543 by fan li, with a registry enrolment figure of 100 participants, started 2025-02-10 and due to reach its primary completion in 2026-10-31. Interventions recorded: AK112 with SCRT and CapeOX; AK112 with SCRT. Conditions listed: Rectal Cancer. Primary outcome: Complete Response Rate. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06718543","url":"https://clinicaltrials.gov/study/NCT06718543"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["ivonescimab","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06718543","phase":"2","setting":"A Multicenter, Randomized, Parallel, Non-Controlled, Prospective Phase II Study of Neoadjuvant Short-Course Radiotherapy Sequential With AK112 With or Without Chemotherapy for Locally Advanced Rectal Cancer","sponsor":"fan li","started":"2025-02-10","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07478731","kind":"trial","name":"Neoadjuvant SHR-1701 Plus Chemoradiotherapy for Locally Advanced Rectal Cancer","aka":["MA-CRC-II-018"],"tldr":"A phase 2 trial in colorectal cancer, run by Hong Qiu, now recruiting.","summary":"Neoadjuvant SHR-1701 Plus Chemoradiotherapy for Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT07478731 by Hong Qiu, with a registry enrolment figure of 48 participants, started 2025-12-20 and due to reach its primary completion in 2027-12-31. Interventions recorded: SHR-1701 neoadjuvant. Conditions listed: CRC (Colorectal Cancer). Primary outcome: pCR. Colorectal eligibility wording from the registry: \"3: Pathologically confirmed rectal adenocarcinoma（At least meet any of the following criteria：cT3-4、cN2、EMVI+、MRF+）\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07478731","url":"https://clinicaltrials.gov/study/NCT07478731"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07478731","phase":"2","setting":"A Phase II, Prospective, Single Arm Study of Neoadjuvant SHR-1701 Combine With Chemoradiotherapy for Locally Advanced Rectal Cancer","sponsor":"Hong Qiu","started":"2025-12-20","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00833248","kind":"trial","name":"Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Degarelix, Goserelin / leuprolide and Bicalutamide in Prostate cancer, run by Ferring Pharmaceuticals, completed.","summary":"Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer is a phase 3 interventional study registered as NCT00833248 by Ferring Pharmaceuticals, with 246 participants recorded, started 2009-04 and reaching its primary completion in 2011-09. Interventions recorded: Degarelix, Goserelin, Bicalutamide. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Degarelix because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00833248","url":"https://clinicaltrials.gov/study/NCT00833248"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["degarelix","goserelin","bicalutamide"],"companies":["ferring"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00833248","phase":"3","setting":"A Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)","sponsor":"Ferring Pharmaceuticals","started":"2009-04","yearReported":2012,"enrolled":246,"enrolledBasis":"registry","outcomes":[{"endpoint":"Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)","primary":true,"unit":"milliliter","arms":[{"name":"Degarelix 240 mg/80 mg","n":176,"value":-36,"note":"SD 14.5; Figures from the ClinicalTrials.gov results section (first posted 2012-09-27), not from a publication"},{"name":"Goserelin (3.6 mg) + Bicalutamide (50 mg)","n":62,"value":-35.3,"note":"SD 16.7"}],"p":"0.8942","source":"https://clinicaltrials.gov/study/NCT00833248?tab=results"}]},{"id":"nct06227117","kind":"trial","name":"Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer","aka":[],"tldr":"A phase 2 trial of Disitamab vedotin, Toripalimab, Carboplatin and Epirubicin in HER2-positive breast cancer, run by RemeGen Co., Ltd., now recruiting.","summary":"Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer is a phase 2 interventional study registered as NCT06227117 by RemeGen Co., Ltd., with 120 participants planned, started 2023-07-27 and due to reach its primary completion in 2025-12. Interventions recorded: Disitamab Vedotin Injection （18 weeks）, Toripalimab （18weeks）, Carboplatin, Disitamab Vedotin Injection （12 weeks）, Sequential Epirubicin and Sequential CTX.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06227117","url":"https://clinicaltrials.gov/study/NCT06227117"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["disitamab-vedotin","toripalimab","carboplatin","epirubicin"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06227117","phase":"2","setting":"A Randomized, Multicenter, Open-Label Phase II Neoadjuvant Study to Evaluate the Safety and Efficacy of Disitamab Vedotin in Combination Toripalimab or Sequence Chemotherapy in Participants With HR-negative, HER2 Low-expressing Breast Cancer","sponsor":"RemeGen Co., Ltd.","started":"2023-07-27","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07394387","kind":"trial","name":"Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin in Triple-Negative Breast Cancer.","aka":[],"tldr":"A phase 2 trial of sintilimab, nab-paclitaxel and carboplatin in triple-negative breast cancer, run by The First Affiliated Hospital with Nanjing Medical University, now recruiting.","summary":"Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin in Triple-Negative Breast Cancer. is a phase 2, randomised interventional study registered as NCT07394387 by The First Affiliated Hospital with Nanjing Medical University, with a registry enrolment figure of 58 participants, started 2025-01-01 and due to reach its primary completion in 2026-06. Interventions recorded: Sintilimab; Abraxane; Carboplatin; High-intensity focused ultrasound (HIFU). Conditions listed: Triple Negative Breast Cancer (TNBC). Triple-negative eligibility wording from the registry: \"Histologically confirmed invasive breast cancer, classified as Stage II-III triple-negative breast cancer (TNBC) according to the 8th edition AJCC TNM staging\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07394387","url":"https://clinicaltrials.gov/study/NCT07394387"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["sintilimab","nab-paclitaxel","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07394387","phase":"2","setting":"A Single-Center, Phase II Clinical Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin Neoadjuvant Therapy in Triple-Negative Breast Cancer.","sponsor":"The First Affiliated Hospital with Nanjing Medical University","started":"2025-01-01","startedType":"actual","enrolled":58,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06987734","kind":"trial","name":"Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab for Patients With Resectable Stage II-IIIA Non-small-cell Lung Cancer Patients","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Shanghai Pulmonary Hospital, Shanghai, China, now recruiting.","summary":"Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab for Patients With Resectable Stage II-IIIA Non-small-cell Lung Cancer Patients is a phase 2, interventional study registered as NCT06987734 by Shanghai Pulmonary Hospital, Shanghai, China, with a registry enrolment figure of 25 participants, started 2025-06-19 and due to reach its primary completion in 2027-12-31. Interventions recorded: Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab. Conditions listed: Lung Cancer (NSCLC). Primary outcome: Major Pathological Response. Lung eligibility wording from the registry: \"Histologically documented, stage II-IIIA Non-Small Cell Lung Cancer (according to version 9th of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and previously untreated\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06987734","url":"https://clinicaltrials.gov/study/NCT06987734"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06987734","phase":"2","setting":"Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab for Patients With Resectable Stage II-IIIA Non-small-cell Lung Cancer Patients","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","started":"2025-06-19","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07178730","kind":"trial","name":"NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer","aka":["ADAPT-TN-IV"],"tldr":"A phase 3 trial of sacituzumab govitecan in triple-negative breast cancer, run by Women's Cancer Study Group GmbH, not yet recruiting.","summary":"NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer is a phase 3, randomised interventional study registered as NCT07178730 by Women's Cancer Study Group GmbH, with a registry enrolment figure of 765 participants, started 2026-08-30 and due to reach its primary completion in 2033-03-31. Interventions recorded: Sacituzumab govitecan; Pembrolizumab 25 mg/1 ML Intravenous Solution [KEYTRUDA]; SoC Chemotherapy. Conditions listed: Breast Cancer; Triple-negative Breast Cancer. Triple-negative eligibility wording from the registry: \"TNBC: ER = 0%, PR = 0%, and HER2- (i\". Sites: Germany. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07178730","url":"https://clinicaltrials.gov/study/NCT07178730"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07178730","phase":"3","setting":"NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer","sponsor":"Women's Cancer Study Group GmbH","started":"2026-08-30","startedType":"estimated","enrolled":765,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07372079","kind":"trial","name":"Neoadjuvant Therapy for Early Triple-Negative Breast Cancer: A Response-Guided Approach Using Iparomlimab and Tuvonralimab Injection in Combination With Chemoth","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"Neoadjuvant Therapy for Early Triple-Negative Breast Cancer: A Response-Guided Approach Using Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy is a phase 2, interventional study registered as NCT07372079 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 40 participants, started 2026-04-05 and due to reach its primary completion in 2028-12-30. Interventions recorded: QL1706 combined with Chemotherapy. Conditions listed: Breast Cancer; Neoadjuvant Therapy; Immune Checkpoint Inhibitors; QL1706. Triple-negative eligibility wording from the registry: \"* Histopathologically confirmed early-stage triple-negative invasive breast cancer as defined by the latest ASCO/CAP guidelines;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07372079","url":"https://clinicaltrials.gov/study/NCT07372079"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07372079","phase":"2","setting":"Neoadjuvant Therapy for Early Triple-Negative Breast Cancer: A Response-Guided Approach Using Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2026-04-05","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07134101","kind":"trial","name":"Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer (SMARTi-RC01)","aka":["SMARTi-RC01"],"tldr":"A phase 2 trial of serplulimab and bevacizumab (glioblastoma use) in colorectal cancer, run by The First Affiliated Hospital with Nanjing Medical University, not yet recruiting.","summary":"Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer (SMARTi-RC01) is a phase 2, randomised interventional study registered as NCT07134101 by The First Affiliated Hospital with Nanjing Medical University, with a registry enrolment figure of 138 participants, started 2025-09-01 and due to reach its primary completion in 2028-08-31. Interventions recorded: Serplulimab; Bevacizumab; Short-Course Radioterapy; Chemotherapy (CAPOX or capecitabine). Conditions listed: Colorectal Cancer (Diagnosis). Primary outcome: Complete Remission (CR) Rate assessed by pathology, MRI, endoscopy, and clinical examination. Colorectal eligibility wording from the registry: \"Diagnosis: Pathologically confirmed rectal adenocarcinoma with proficient mismatch repair (pMMR) / microsatellite stable (MSS) status, based on biopsy of the primary tumor\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07134101","url":"https://clinicaltrials.gov/study/NCT07134101"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["serplulimab","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07134101","phase":"2","setting":"Neoadjuvant Chemoradiotherapy Combined With Serplulimab With or Without Bevacizumab for Locally Advanced Rectal Cancer: A Single-Center, Open-Label, Phase II Randomized Trial","sponsor":"The First Affiliated Hospital with Nanjing Medical University","started":"2025-09-01","startedType":"estimated","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06437977","kind":"trial","name":"Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients(neoR-TORCH)","aka":["neoR-TORCH"],"tldr":"A phase 3 trial of toripalimab in lung cancer, run by Shanghai Chest Hospital, now recruiting.","summary":"Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients(neoR-TORCH) is a phase 3, randomised interventional study registered as NCT06437977 by Shanghai Chest Hospital, with a registry enrolment figure of 478 participants, started 2024-09-12 and due to reach its primary completion in 2027-06. Interventions recorded: SBRT; Toripalimab. Conditions listed: Stage II-III Non-small Cell Lung Cancer. Primary outcome: 2-year Event Free Survival Rate; pCR rate. Lung eligibility wording from the registry: \"Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (N2) (AJCC staging system, version 8) NSCLC ;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06437977","url":"https://clinicaltrials.gov/study/NCT06437977"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","sbrt"],"targets":[],"drugs":["toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06437977","phase":"3","setting":"Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients: A Multicenter, Openlabel, Randomized, Phase III Trial","sponsor":"Shanghai Chest Hospital","started":"2024-09-12","startedType":"actual","enrolled":478,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05429463","kind":"trial","name":"Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE II）","aka":["neoSCORE II"],"tldr":"A phase 3 trial of sintilimab, carboplatin and nab-paclitaxel in lung cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE II） is a phase 3, randomised interventional study registered as NCT05429463 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 250 participants, started 2022-11-11 and due to reach its primary completion in 2025-11-11. Interventions recorded: Sintilimab; Carboplatin; Albumin-Bound Paclitaxel. Conditions listed: Squamous Cell Non-small Cell Lung Cancer. Primary outcome: Major pathological response rate (MPR). Lung eligibility wording from the registry: \"Squamous Cell Non-small cell lung cancer confirmed by cytology or histology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05429463","url":"https://clinicaltrials.gov/study/NCT05429463"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["sintilimab","carboplatin","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05429463","phase":"3","setting":"Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE II）：A Prospective, Randomized, Open-Label, Multi-Center Phase 3 Trial","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2022-11-11","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05378919","kind":"trial","name":"Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer","aka":["RECTUM2015"],"tldr":"A phase 2 trial of fluorouracil (5-FU) in colorectal cancer, run by Lithuanian University of Health Sciences, now recruiting.","summary":"Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT05378919 by Lithuanian University of Health Sciences, with a registry enrolment figure of 250 participants, started 2015-06-01 and due to reach its primary completion in 2025-06-01. Interventions recorded: Radiotherapy 50 Gy; Fluorouracil/folic acid; Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4); Radiotherapy 50 Gy. Conditions listed: Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX. Primary outcome: disease-free survival. Colorectal eligibility wording from the registry: \"* diagnosed with rectal adenocarcinoma;\". Sites: Lithuania. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05378919","url":"https://clinicaltrials.gov/study/NCT05378919"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05378919","phase":"2","setting":"Evaluation and Comparison of the Efficacy of a New Standard Pre-operative Chemotherapy for Stage II and III Colorectal Cancer According to the FOLFOX4 Regimen With Routine Chemoradiation Therapy","sponsor":"Lithuanian University of Health Sciences","started":"2015-06-01","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06977542","kind":"trial","name":"Neoadjuvant Therapy With Ivonescimab Combined With Chemotherapy for Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of ivonescimab in triple-negative breast cancer, run by Fudan University, not yet recruiting.","summary":"Neoadjuvant Therapy With Ivonescimab Combined With Chemotherapy for Triple-Negative Breast Cancer is a phase 2, interventional study registered as NCT06977542 by Fudan University, with a registry enrolment figure of 53 participants, started 2025-06 and due to reach its primary completion in 2029-01. Interventions recorded: Ivonescimab. Conditions listed: TNBC, Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Patients with Triple Negative breast cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06977542","url":"https://clinicaltrials.gov/study/NCT06977542"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06977542","phase":"2","setting":"A Single-Arm, Phase II Clinical Study of Neoadjuvant Therapy With Ivonescimab Combined With Chemotherapy in Patients With Early or Locally Advanced Triple-Negative Breast Cancer","sponsor":"Fudan University","started":"2025-06","startedType":"estimated","enrolled":53,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06903273","kind":"trial","name":"Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Resectable High-risk Cholangiocarcinoma","aka":["TisGCS for BTC"],"tldr":"A phase 2 trial of tislelizumab, gemcitabine, cisplatin and S-1 in gallbladder cancer and other biliary tract cancers, run by National Cheng-Kung University Hospital, not yet recruiting.","summary":"Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Resectable High-risk Cholangiocarcinoma is a phase 2 interventional study registered as NCT06903273 by National Cheng-Kung University Hospital, with a registry enrolment figure of 35 participants, started 2025-07-01 and due to reach its primary completion in 2028-07-01. Interventions recorded: Tislelizumab. Conditions listed: Cholangiocarcinoma, Biliary Tract Cancer (BTC). Sites: Taiwan. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06903273","url":"https://clinicaltrials.gov/study/NCT06903273"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["tislelizumab","gemcitabine","cisplatin","tegafur-gimeracil-oteracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06903273","phase":"2","setting":"Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Patients with Resectable High-risk Intrahepatic Cholangiocarcinoma","sponsor":"National Cheng-Kung University Hospital","started":"2025-07-01","startedType":"estimated","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07457359","kind":"trial","name":"Neoadjuvant Toripalimab Plus SBRT for Chemo-Resistant Triple-Negative Breast Cancer","aka":["NEOTRIO-2"],"tldr":"A phase 2 trial of toripalimab in triple-negative breast cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"Neoadjuvant Toripalimab Plus SBRT for Chemo-Resistant Triple-Negative Breast Cancer is a phase 2, interventional study registered as NCT07457359 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 18 participants, started 2026-01-04 and due to reach its primary completion in 2028-01-04. Interventions recorded: SBRT; Toripalimab (anti-PD-1 antibody); Chemotherapy switch. Conditions listed: TNBC, Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Histologically confirmed triple-negative phenotype: ER \\< 1 %, PR \\< 1 % by IHC, HER2 negative (IHC 0/1+ or IHC 2+ with ISH negative)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07457359","url":"https://clinicaltrials.gov/study/NCT07457359"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07457359","phase":"2","setting":"Neoadjuvant Toripalimab Combined With Preoperative Radiotherapy for Initial Chemotherapy-Nonresponding Triple-Negative Breast Cancer Patients (NEOTRIO-2)","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2026-01-04","startedType":"actual","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03926338","kind":"trial","name":"Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer","aka":["PICC"],"tldr":"A phase 2 trial of toripalimab in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer is a phase 2, randomised interventional study registered as NCT03926338 by Sun Yat-sen University, with a registry enrolment figure of 270 participants, started 2019-05-10 and due to reach its primary completion in 2027-04-01. Interventions recorded: Neoadjuvant toripalimab plus celecoxib for 6 cycles; Neoadjuvant toripalimab monotherapy for 6 cycles; Neoadjuvant toripalimab plus celecoxib for 12 cycles; Neoadjuvant toripalimab monotherapy for 12 cycles; Toripalimab plus celecoxib as neoadjuvant or definitive therapy. Conditions listed: Colorectal Cancer; Mismatch Repair-deficient (dMMR); Microsatellite Instability-high (MSI-H); Neoadjuvant Therapy. Primary outcome: Pathological complete response (pCR) rates (PICC-1 and PICC-2 cohorts); Event-free survival (EFS) (PICC-3 cohort). Colorectal eligibility wording from the registry: \"Histological or cytological documentation of adenocarcinoma of the colon or rectum\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03926338","url":"https://clinicaltrials.gov/study/NCT03926338"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03926338","phase":"2","setting":"Neoadjuvant PD-1 Blockade by Toripalimab With or Without Celecoxib in Mismatch-repair Deficient or Microsatellite Instability-high Locally Advanced Colorectal Cancer (PICC)","sponsor":"Sun Yat-sen University","started":"2019-05-10","startedType":"actual","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07581912","kind":"trial","name":"Neoadjuvant Treatment of Fulzerasib Plus Cetuximab N01 in KRAS G12C Mutated Locally Advanced Colorectal Cancer With or Without Resectable Metastases","aka":[],"tldr":"A phase 2 trial of Fulzerasib in Colorectal cancer, run by Zhejiang University, now recruiting.","summary":"Neoadjuvant Treatment of Fulzerasib Plus Cetuximab N01 in KRAS G12C Mutated Locally Advanced Colorectal Cancer With or Without Resectable Metastases is a phase 2 interventional study registered as NCT07581912 by Zhejiang University, with 40 participants planned, started 2026-04-30 and due to reach its primary completion in 2028-12. Interventions recorded: fulzerasib; cetuximab N01. Conditions recorded: Colorectal Cancer, KRAS G12C Mutant Advanced Solid Tumors, Fulzerasib, Cetuximab N01.\n\nLinked to the drug Fulzerasib because the registry names it among its interventions and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07581912","url":"https://clinicaltrials.gov/study/NCT07581912"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","kras-g12c-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["fulzerasib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07581912","phase":"2","setting":"Neoadjuvant Treatment of Fulzerasib Plus Cetuximab N01 in KRAS G12C Mutated Locally Advanced Colorectal Cancer With or Without Resectable Metastases","sponsor":"Zhejiang University","started":"2026-04-30","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06691594","kind":"trial","name":"Neoadjuvant Treatment of Triple-Negative Breast Cancer with Stereotactic Radiotherapy, PD-1 Monoclonal Antibody, and Chemotherapy","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, not yet recruiting.","summary":"Neoadjuvant Treatment of Triple-Negative Breast Cancer with Stereotactic Radiotherapy, PD-1 Monoclonal Antibody, and Chemotherapy is a phase 2, interventional study registered as NCT06691594 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 20 participants, started 2025-02 and due to reach its primary completion in 2028-11. Interventions recorded: neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy. Conditions listed: Breast Cancer Invasive. Triple-negative eligibility wording from the registry: \"Triple-negative breast cancer with PD-L1 CPS \\< 10\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06691594","url":"https://clinicaltrials.gov/study/NCT06691594"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06691594","phase":"2","setting":"Prospective, Single-arm, Phase II Study of Stereotactic Radiotherapy Combined with PD-1 Monoclonal Antibody and Chemotherapy As Neoadjuvant Treatment for Triple-negative Breast Cancer","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2025-02","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07155629","kind":"trial","name":"Neoadjuvant Treatment vs Upfront Surgery for Left-Sided Pancreatic Cancer","aka":["LEFT-PANC"],"tldr":"A phase 3 trial in pancreatic cancer, run by Helsinki University Central Hospital, not yet recruiting.","summary":"Neoadjuvant Treatment vs Upfront Surgery for Left-Sided Pancreatic Cancer is a phase 3, randomised interventional study registered as NCT07155629 by Helsinki University Central Hospital, with a registry enrolment figure of 381 participants, started 2025-09-01 and due to reach its primary completion in 2030-08-31. Interventions recorded: mFOLFIRINOX neoadjuvant chemotherapy / Nab-paclitaxel and gemcitabine. Conditions listed: Pancreatic Cancer Resectable. Primary outcome: Overall Survival. Pancreatic eligibility wording from the registry: \"* Resectable left pancreatic cancer according to NCCN criteria\". Sites: Finland. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07155629","url":"https://clinicaltrials.gov/study/NCT07155629"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07155629","phase":"3","setting":"Neoadjuvant Treatment vs Upfront Surgery for Left Sided Pancreatic Cancer (LEFT-PANC) - a Study Protocol for a Prospective Randomized Multicenter Trial","sponsor":"Helsinki University Central Hospital","started":"2025-09-01","startedType":"estimated","enrolled":381,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05571644","kind":"trial","name":"Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer","aka":["OPTICAL-2"],"tldr":"A phase 2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) and FOLFOXIRI in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer is a phase 2, randomised interventional study registered as NCT05571644 by Sun Yat-sen University, with a registry enrolment figure of 143 participants, started 2023-07-10 and due to reach its primary completion in 2025-12-31. Interventions recorded: mFOLFOXIRI + Cadonilimab; mFOLFOX6; mFOLFOXIRI; mFOLFOXIRI+AK104+fruquintinib. Conditions listed: Colorectal Cancer. Primary outcome: Pathological complete response (pCR) rates. Colorectal eligibility wording from the registry: \"Colorectal adenocarcinoma with definite histological evidence;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05571644","url":"https://clinicaltrials.gov/study/NCT05571644"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfox","folfoxiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05571644","phase":"2","setting":"Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 Alone in Locally Advanced Colorectal Cancer: a Randomized Control Phase II Study (OPTICAL-2)","sponsor":"Sun Yat-sen University","started":"2023-07-10","startedType":"actual","enrolled":143,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06384560","kind":"trial","name":"Neoadjuvant Triple Therapy for (Borderline) Resectable Pancreatic Cancer (PREOPANC-5)","aka":["PREOPANC-5"],"tldr":"A phase 1/2 trial of pembrolizumab and fOLFIRINOX / mFOLFIRINOX in pancreatic cancer, run by Amsterdam UMC, location VUmc, now recruiting.","summary":"Neoadjuvant Triple Therapy for (Borderline) Resectable Pancreatic Cancer (PREOPANC-5) is a phase 1/2, interventional study registered as NCT06384560 by Amsterdam UMC, location VUmc, with a registry enrolment figure of 66 participants, started 2024-09-23 and due to reach its primary completion in 2028-03. Interventions recorded: Pembrolizumab; Folfirinox; SABR. Conditions listed: Localized Pancreatic Adenocarcinoma; Borderline Resectable Pancreatic Adenocarcinoma; Resectable Pancreatic Adenocarcinoma. Primary outcome: 1-year progression-free survival rate. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed adenocarcinoma of the pancreas (WHO VI or VII)\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06384560","url":"https://clinicaltrials.gov/study/NCT06384560"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","sbrt","topoisomerase-inhibitors"],"targets":[],"drugs":["pembrolizumab","folfirinox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06384560","phase":"1/2","setting":"Neoadjuvant Triple Treatment With mFOLFIRINOX, Pembrolizumab and SABR in Patients With (Borderline) Resectable Pancreatic Cancer (PREOPANC-5): a Multicenter Single Arm Phase Ib/II Trial of the Dutch Pancreatic Cancer Group","sponsor":"Amsterdam UMC, location VUmc","started":"2024-09-23","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07081360","kind":"trial","name":"Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer","aka":[],"tldr":"A phase 3 trial in pancreatic cancer, run by Minia University, now recruiting.","summary":"Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer is a phase 3, randomised interventional study registered as NCT07081360 by Minia University, with a registry enrolment figure of 262 participants, started 2025-07-20 and due to reach its primary completion in 2028-07-20. Interventions recorded: Neoadjuvant chemotherapy; Upfront Surgery Group. Conditions listed: Pancreas Cancer; Periampullary Cancer; Periampullary Carcinoma Resectable; Pancreatic Cancer Resectable; Ampullary Cancer; Pancreas Adenocarcinoma. Primary outcome: Overall survival rate. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed pancreatic head cancer or periampullary carcinoma(endoscopic ultrasound (EUS)-guided biopsy)\". Sites: Egypt. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07081360","url":"https://clinicaltrials.gov/study/NCT07081360"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07081360","phase":"3","setting":"Neoadjuvant Chemotherapy Followed by Surgery Versus Upfront Surgery for Clearly Resectable Pancreatic Head Cancer and Periampullary Cancer: A Randomized Controlled Trial","sponsor":"Minia University","started":"2025-07-20","startedType":"actual","enrolled":262,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05765877","kind":"trial","name":"Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Iruplinalkib in Non-small-cell lung cancer, run by Pingping Song, now recruiting.","summary":"Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT05765877 by Pingping Song, with 26 participants planned, started 2023-03-01 and due to reach its primary completion in 2027-03. Interventions recorded: WX-0593 Tablets. Conditions recorded: Non-Small Cell Lung Cancer(NSCLC).\n\nLinked to the drug Iruplinalkib because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05765877","url":"https://clinicaltrials.gov/study/NCT05765877"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","alk-positive-nsclc","resectable-nsclc","ros1-positive-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["iruplinalkib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05765877","phase":"2","setting":"Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer: a Single-arm, Exploratory Trial","sponsor":"Pingping Song","started":"2023-03-01","startedType":"actual","enrolled":26,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07188246","kind":"trial","name":"Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer","aka":["BRINK"],"tldr":"A phase 2 trial of pembrolizumab in triple-negative breast cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, now recruiting.","summary":"Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer is a phase 2, interventional study registered as NCT07188246 by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, with a registry enrolment figure of 40 participants, started 2026-01-19 and due to reach its primary completion in 2027-07. Interventions recorded: Radiation; Pembrolizumab (KEYTRUDA®). Conditions listed: Breast Cancer; Breast Cancer Stage II; Breast Cancer Stage III; Breast Cancer Invasive; Breast Cancer Triple Negative. Triple-negative eligibility wording from the registry: \"Stage IIA is eligible for triple negative and HER2+ breast cancers\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07188246","url":"https://clinicaltrials.gov/study/NCT07188246"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07188246","phase":"2","setting":"A Trial of Neoadjuvant, Hypofractionated Radiation, With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy, in Stage 3 or High-risk Stage 2 Breast Cancer","sponsor":"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","started":"2026-01-19","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07412613","kind":"trial","name":"Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer","aka":[],"tldr":"A phase 3 trial of Cadonilimab, CAPOX, Capecitabine in colorectal cancer, run by Akeso, now recruiting.","summary":"Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer is a phase 3 interventional study registered as NCT07412613 by Akeso, with 386 participants planned, started 2026-04-15 and due to reach its primary completion in 2030-06-15. Interventions recorded: Cadonilimab (AK104), Oxaliplatin, Capecitabine, 5- Fluorouracil, Calcium Folinate. Conditions listed: Resectable Colon Cancer, MSI-H/dMMR Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07412613","url":"https://clinicaltrials.gov/study/NCT07412613"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","msi-high-colorectal"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["cadonilimab","capox","capecitabine","leucovorin"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07412613","phase":"3","setting":"A Randomized, Open-label, Controlled, Multicenter Phase 3 Clinical Trial of AK104 for Neoadjuvant/Adjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer","sponsor":"Akeso","started":"2026-04-15","startedType":"actual","enrolled":386,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05562297","kind":"trial","name":"Neoadjuvant/Adjuvant Sintilimab, Nab-paclitaxel, and Gemcitabine for Resectable/Borderline Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of sintilimab, nab-paclitaxel and gemcitabine in pancreatic cancer, run by Shanghai Zhongshan Hospital, not yet recruiting.","summary":"Neoadjuvant/Adjuvant Sintilimab, Nab-paclitaxel, and Gemcitabine for Resectable/Borderline Resectable Pancreatic Cancer is a phase 2, interventional study registered as NCT05562297 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 50 participants, started 2025-03-20 and due to reach its primary completion in 2027-10-01. Interventions recorded: sintilimab; nab-paclitaxel; gemcitabine. Conditions listed: Pancreatic Cancer, Stage IB; Pancreatic Cancer, Stage IIA; Pancreatic Cancer, Stage IIB; Pancreatic Cancer Stage III. Primary outcome: 2-year overall survival after the application of sintilimab and gemcitabine plus nab-paclitaxel. Pancreatic eligibility wording from the registry: \"* Patients must have imaging evaluations to confirm that their pancreatic adenocarcinoma is resectable and borderline resectable\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05562297","url":"https://clinicaltrials.gov/study/NCT05562297"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["sintilimab","nab-paclitaxel","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05562297","phase":"2","setting":"A Phase II Study to Evaluate the Safety and Efficacy of Sintilimab Combined With Nab-paclitaxel and Gemcitabine for Neoadjuvant and Adjuvant Therapy of Patients With Resectable and Borderline Resectable Pancreatic Cancer","sponsor":"Shanghai Zhongshan Hospital","started":"2025-03-20","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04912765","kind":"trial","name":"Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC","aka":[],"tldr":"A phase 2 trial of nivolumab in colorectal cancer, run by National Cancer Centre, Singapore, now recruiting.","summary":"Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC is a phase 2, interventional study registered as NCT04912765 by National Cancer Centre, Singapore, with a registry enrolment figure of 60 participants, started 2021-04-15 and due to reach its primary completion in 2026-12. Interventions recorded: Neoantigen Dendritic Cell Vaccine; Nivolumab. Conditions listed: Hepatocellular Carcinoma; Hepatocellular Cancer; Colorectal Cancer; Colorectal Carcinoma; Liver Metastases. Primary outcome: 24-month Relapse Free Survival; Induced immune response against vaccinated NAs. Colorectal eligibility wording from the registry: \"* Patients with histologically- or cytologically-diagnosed colorectal cancer with liver-limited metastases are eligible to enrol if:\". Sites: Singapore. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04912765","url":"https://clinicaltrials.gov/study/NCT04912765"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","neoantigen-mrna-vaccine"],"targets":[],"drugs":["nivolumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04912765","phase":"2","setting":"An Open Label, Single-arm, Phase II Neoantigen (NA) Dendritic Cell (DC) Vaccine and Anti-PD1 (Nivolumab) as Adjuvant Treatment in Resected Hepatocellular Carcinoma (HCC) (Group A) and Liver Metastases From Colorectal Cancer (CRLM) (Group B)","sponsor":"National Cancer Centre, Singapore","started":"2021-04-15","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06845319","kind":"trial","name":"NeoCARD: Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer Patients","aka":["NeoCARD"],"tldr":"A phase 2 trial of carboplatin, paclitaxel / nab-paclitaxel and pembrolizumab in triple-negative breast cancer, run by Medical University of South Carolina, now recruiting.","summary":"NeoCARD: Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer Patients is a phase 2, interventional study registered as NCT06845319 by Medical University of South Carolina, with a registry enrolment figure of 43 participants, started 2025-10-20 and due to reach its primary completion in 2027-10-20. Interventions recorded: Carboplatin; Paclitaxel; Pembrolizumab. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Histologically confirmed triple-negative breast cancer (TNBC) or hormone receptor-low invasive breast carcinoma, with clinical anatomic Stage II or Stage IIIA/B disease as defined by the AJCC 8th Edition Breast Cancer Stating System\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06845319","url":"https://clinicaltrials.gov/study/NCT06845319"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","paclitaxel","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06845319","phase":"2","setting":"NeoCARD: A Response-Adapted Phase II Study of Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer Patients With Cardiomyopathy or Elevated Risk of Cardiotoxicity","sponsor":"Medical University of South Carolina","started":"2025-10-20","startedType":"actual","enrolled":43,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05529940","kind":"trial","name":"NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)","aka":["NeoFOL-R"],"tldr":"A phase 3 trial of fOLFIRINOX / mFOLFIRINOX in pancreatic cancer, run by Seoul National University Hospital, now recruiting.","summary":"NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer) is a phase 3, randomised interventional study registered as NCT05529940 by Seoul National University Hospital, with a registry enrolment figure of 609 participants, started 2023-04-01 and due to reach its primary completion in 2024-12. Interventions recorded: Folfirinox. Conditions listed: Resectable Pancreatic Cancer; Neoadjuvant Chemotherapy; Effects of Chemotherapy. Primary outcome: 2-year survival rate. Pancreatic eligibility wording from the registry: \"Pancreatic ductal adenocarcinoma diagnosed by histological examination (histologic or cytopathological) D\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05529940","url":"https://clinicaltrials.gov/study/NCT05529940"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfirinox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05529940","phase":"3","setting":"Efficacy of Perioperative Versus Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer: an International Multicenter Randomized Controlled Trial (NeoFOL-R Trial)","sponsor":"Seoul National University Hospital","started":"2023-04-01","startedType":"actual","enrolled":609,"enrolledBasis":"registry","outcomes":[]},{"id":"neogb","kind":"trial","name":"NEOGB","aka":[],"tldr":"NEOGB is an Indian phase 3 trial testing whether chemotherapy before surgery improves three-year survival in gallbladder cancer that is still removable but locally advanced. It opened in January 2025 and plans 114 patients.","summary":"NEOGB (NCT06712420) randomises patients with locally advanced but resectable gallbladder carcinoma to neoadjuvant chemotherapy followed by curative surgery or to upfront surgery. Eligibility includes post-cholecystectomy gallbladder cancer with residual disease on imaging, a history of bile spillage or piecemeal removal during the index cholecystectomy, and regional lymph node involvement on imaging. The primary endpoint is improvement in three-year overall survival; 114 patients are planned at three Indian sites, recruitment began in January 2025 and primary completion is listed for April 2028. It complements POLCAGB (unresectable locally advanced disease) and OPT-IN (incidental T2 to T3 disease) as the third randomised test of neoadjuvant treatment in gallbladder cancer.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06712420","url":"https://clinicaltrials.gov/study/NCT06712420"}],"tags":["india"],"related":[],"cancers":["gallbladder","incidental-gallbladder-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","gallbladder-cancer-surgery"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["radical-cholecystectomy","hepatectomy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06712420","phase":"3","setting":"Locally advanced resectable gallbladder cancer (including residual disease after cholecystectomy, bile spillage, piecemeal removal or regional node involvement on imaging): neoadjuvant chemotherapy then surgery versus upfront surgery","sponsor":"Rajiv Gandhi Cancer Institute and Research Centre, India","started":"2025-01-01","startedType":"actual","enrolled":114,"enrolledBasis":"registry","outcomes":[]},{"id":"neolap","kind":"trial","name":"NEOLAP","aka":["NEOLAP-AIO-PAK-0113","AIO-PAK-0113"],"tldr":"NEOLAP asked whether switching to FOLFIRINOX after two months of gemcitabine and nab-paclitaxel converts more inoperable pancreatic cancers to operable ones; about a third to 44 percent were removed with either sequence and survival was similar, so both induction regimens are acceptable.","summary":"NEOLAP randomised 130 of 168 registered patients (64 to continued nab-paclitaxel plus gemcitabine, 66 to sequential FOLFIRINOX) between November 2014 and April 2018. Surgical exploration was done in 63 and 64 percent; complete macroscopic resection in 23 and 29 patients, a conversion rate of 35.9 percent (95 percent confidence interval 24.3 to 48.9) against 43.9 percent (31.7 to 56.7) (odds ratio 0.72; p 0.38). Median overall survival was 18.5 months against 20.7 months (hazard ratio 0.86; p 0.53), with better histopathological downstaging after FOLFIRINOX (ypT1/2 in 69 against 17 percent). Grade 3 or worse events during induction occurred in 55 and 53 percent, including bile duct obstruction with cholangitis in 9 and 11 percent. The trial underpins the corpus's locally advanced row: four to six months of multi-agent induction, surgical exploration for responders, and no proven advantage of one backbone over the other.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02125136","url":"https://clinicaltrials.gov/study/NCT02125136"},{"label":"Kunzmann et al., NEOLAP (Lancet Gastroenterology and Hepatology 2021)","url":"https://doi.org/10.1016/S2468-1253(20)30330-7"}],"tags":[],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel","folfirinox"],"companies":["aio"],"institutions":[],"pathways":[],"terms":["resectability","acute-cholangitis"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02125136","phase":"2","setting":"Treatment-naive locally advanced pancreatic adenocarcinoma at 28 German centres: after two cycles of nab-paclitaxel plus gemcitabine, two further cycles of the same against four cycles of FOLFIRINOX, all followed by surgical exploration, with the surgical conversion rate as the primary endpoint","sponsor":"AIO-Studien-gGmbH (German pancreatic cancer group), with Celgene","result":"Surgical conversion 35.9 percent with continued nab-paclitaxel plus gemcitabine against 43.9 percent with sequential FOLFIRINOX (odds ratio 0.72; p 0.38); median overall survival 18.5 against 20.7 months (hazard ratio 0.86; p 0.53).","started":"2014-11","startedType":"actual","yearReported":2021,"enrolled":130,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov NCT02125136 lists an estimated 168 participants; 168 were registered and 130 without progression after two cycles of nab-paclitaxel plus gemcitabine were randomised according to the Lancet Gastroenterology and Hepatology 2021 report.","outcomes":[{"endpoint":"Surgical conversion rate (complete macroscopic resection)","primary":true,"unit":"%","arms":[{"name":"Nab-paclitaxel + gemcitabine x4","n":64,"value":35.9,"note":"95% CI 24.3 to 48.9"},{"name":"Nab-paclitaxel + gemcitabine x2 then FOLFIRINOX x4","n":66,"value":43.9,"note":"95% CI 31.7 to 56.7"}],"p":"0.38","source":"https://doi.org/10.1016/S2468-1253(20)30330-7"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Nab-paclitaxel + gemcitabine x4","value":18.5},{"name":"Nab-paclitaxel + gemcitabine x2 then FOLFIRINOX x4","value":20.7}],"hr":0.86,"ci":[0.55,1.36],"p":"0.53","source":"https://doi.org/10.1016/S2468-1253(20)30330-7"}]},{"id":"neonax","kind":"trial","name":"NEONAX","aka":["AIO-PAK-0313"],"tldr":"NEONAX compared giving gemcitabine and nab-paclitaxel around surgery with giving it only afterwards; neither arm reached the trial's 55 percent target for being relapse-free at 18 months, but patients treated before surgery lived a median 25.5 months against 16.7, mostly because so few in the surgery-first arm were ever fit enough to start chemotherapy.","summary":"NEONAX randomised 127 patients 1 to 1 to perioperative (arm A) or adjuvant-only (arm B) gemcitabine 1,000 mg/m2 with nab-paclitaxel 125 mg/m2 on days 1, 8 and 15 of 28-day cycles. The pre-defined 18-month disease-free survival rate of 55 percent was reached in neither arm (A 33.3 percent, 95 percent confidence interval 18.5 to 48.1; B 41.4 percent, 20.7 to 62.0, in the modified intention-to-treat population of resected patients who started their allocated chemotherapy). Ninety percent of arm A completed neoadjuvant treatment while only 42 percent of arm B started adjuvant chemotherapy; R0 resection was 88 against 67 percent. In the full intention-to-treat population median overall survival was 25.5 months (19.7 to 29.7) in the perioperative arm against 16.7 months (11.6 to 22.2) with upfront surgery, and median disease-free survival 11.5 against 5.9 months. The authors called neoadjuvant treatment a novel option whose regimen remains to be defined; the corpus cites the trial beside NORPACT-1 and SWOG S1505 as the phase 2 evidence that frames Alliance A021806 and PREOPANC-3.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02047513","url":"https://clinicaltrials.gov/study/NCT02047513"},{"label":"Seufferlein et al., NEONAX (Annals of Oncology 2023)","url":"https://doi.org/10.1016/j.annonc.2022.09.161"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel"],"companies":["aio"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02047513","phase":"2","setting":"Resectable pancreatic ductal adenocarcinoma at 22 German centres: two cycles of gemcitabine plus nab-paclitaxel before surgery and four after, against six adjuvant cycles after upfront surgery, with 18-month disease-free survival as the primary endpoint in each arm","sponsor":"AIO-Studien-gGmbH (German pancreatic cancer group), with Celgene","result":"18-month disease-free survival 33.3 percent (perioperative) and 41.4 percent (adjuvant), both below the 55 percent target; median overall survival 25.5 against 16.7 months in the intention-to-treat population.","started":"2015-07","startedType":"actual","yearReported":2023,"enrolled":127,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 18 months (modified intention to treat)","primary":true,"unit":"%","arms":[{"name":"Perioperative gemcitabine + nab-paclitaxel","value":33.3,"note":"95% CI 18.5 to 48.1"},{"name":"Adjuvant gemcitabine + nab-paclitaxel after upfront surgery","value":41.4,"note":"95% CI 20.7 to 62.0"}],"source":"https://doi.org/10.1016/j.annonc.2022.09.161"},{"endpoint":"Overall survival (intention to treat)","unit":"months","arms":[{"name":"Perioperative gemcitabine + nab-paclitaxel","value":25.5,"note":"95% CI 19.7 to 29.7"},{"name":"Adjuvant gemcitabine + nab-paclitaxel after upfront surgery","value":16.7,"note":"95% CI 11.6 to 22.2"}],"source":"https://doi.org/10.1016/j.annonc.2022.09.161"}]},{"id":"neopact","kind":"trial","name":"NeoPACT","aka":[],"tldr":"NeoPACT tested a shorter, anthracycline-free pre-operative combination of carboplatin, docetaxel and pembrolizumab in triple-negative breast cancer. Tumours disappeared completely in 58 percent of women and 86 percent were free of events at three years, which is the basis for the SCARLET phase 3 comparison with the KEYNOTE-522 regimen.","summary":"NeoPACT (NCT03639948) was a single-arm phase 2 trial of 115 eligible patients (120 registered) with stage I to III triple-negative breast cancer enrolled from 2018 to 2022 at two US sites, who received neoadjuvant carboplatin AUC 6 and docetaxel 75 mg/m2 with pembrolizumab 200 mg every 21 days for six cycles with growth-factor support. Pathological complete response was 58 percent (95 percent confidence interval 48 to 67) and residual cancer burden 0 or 1 was 69 percent; grade 3 or higher immune-mediated adverse events occurred in 3.5 percent. Estimated three-year event-free survival was 86 percent overall, 98 percent after pathological complete response and 68 percent without it. Stromal TILs, PD-L1, the DNA damage immune response signature and the 27-gene tumour immune microenvironment signature each independently predicted response. The regimen is now the experimental arm of SWOG S2212 (SCARLET), which randomises it against the KEYNOTE-522 regimen with response-adapted adjuvant therapy in 2,400 patients.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03639948","url":"https://clinicaltrials.gov/study/NCT03639948"},{"label":"Sharma et al., JAMA Oncology 2024: NeoPACT clinical and biomarker findings","url":"https://doi.org/10.1001/jamaoncol.2023.5033"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","platinum","cytotoxic-chemotherapy"],"targets":[],"drugs":["carboplatin","docetaxel","pembrolizumab","pegfilgrastim"],"companies":["merck"],"institutions":[],"pathways":[],"terms":["pcr","rcb","tils","de-escalation"],"trials":["scarlet-s2212","keynote-522"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03639948","phase":"2","setting":"Stage I to III triple-negative breast cancer: neoadjuvant carboplatin and docetaxel with pembrolizumab for six cycles, anthracycline-free, single arm, two US sites","sponsor":"University of Kansas Medical Center, with Merck","result":"pCR 58% (48 to 67); RCB 0 or 1 69%; 3-year EFS 86% (98% with pCR, 68% without).","started":"2018-09-04","startedType":"actual","yearReported":2024,"enrolled":120,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathological complete response","primary":true,"unit":"%","arms":[{"name":"Carboplatin + docetaxel + pembrolizumab","n":115,"value":58}],"ci":[48,67],"source":"https://doi.org/10.1001/jamaoncol.2023.5033"},{"endpoint":"Event-free survival at 3 years","unit":"%","arms":[{"name":"All patients","value":86},{"name":"Pathological complete response","value":98},{"name":"No pathological complete response","value":68}],"source":"https://doi.org/10.1001/jamaoncol.2023.5033"}],"replication":"Being tested against the KEYNOTE-522 regimen in SWOG S2212 (SCARLET)."},{"id":"neosphere","kind":"trial","name":"NeoSphere","aka":[],"tldr":"NeoSphere showed that blocking HER2 with two antibodies, pertuzumab and trastuzumab, alongside chemotherapy before surgery made HER2-positive breast tumours disappear completely more often than one antibody alone, which led to the first approval of a cancer drug for use before surgery.","summary":"NeoSphere was an open-label randomised phase 2 trial in women with operable, locally advanced or inflammatory HER2-positive breast cancer. Four neoadjuvant arms were compared: trastuzumab plus docetaxel; pertuzumab, trastuzumab and docetaxel; pertuzumab plus trastuzumab without chemotherapy; and pertuzumab plus docetaxel. All patients had surgery followed by anthracycline chemotherapy and a year of trastuzumab.\n\nThe pertuzumab, trastuzumab and docetaxel arm had a significantly higher pathological complete response rate than trastuzumab plus docetaxel, the primary endpoint, and the chemotherapy-free antibody pair produced complete responses in a minority of patients. Together with TRYPHAENA, NeoSphere supported the accelerated approval of neoadjuvant pertuzumab in the United States in September 2013, the first drug approved on a neoadjuvant pathological response endpoint; five-year follow-up showed the pathological response tracked with fewer recurrences.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00545688","url":"https://clinicaltrials.gov/study/NCT00545688"}],"tags":["subtype-trials"],"related":[],"cancers":["her2-positive-early-breast-cancer","breast-her2-positive"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["pertuzumab","trastuzumab","docetaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["luca-gianni"],"bottlenecks":[],"keyPapers":["paper-neosphere-lancet-oncol-2012","paper-neosphere-lancet-oncol-2016-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00545688","phase":"2","setting":"Operable, locally advanced or inflammatory HER2-positive breast cancer before surgery: trastuzumab with docetaxel, pertuzumab and trastuzumab with docetaxel, pertuzumab and trastuzumab without chemotherapy, or pertuzumab with docetaxel","sponsor":"Roche","result":"Pertuzumab added to trastuzumab and docetaxel raised the pathological complete response rate in HER2-positive breast cancer; neoadjuvant pertuzumab received accelerated approval in September 2013.","started":"2006-06-26","startedType":"actual","yearReported":2012,"enrolled":417,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathological complete response in the breast","primary":true,"unit":"%","arms":[{"name":"Pertuzumab + trastuzumab + docetaxel (group B)","n":107,"value":45.8,"note":"95% CI 36.1 to 55.7"},{"name":"Trastuzumab + docetaxel (group A)","n":107,"value":29,"note":"95% CI 20.6 to 38.5"},{"name":"Pertuzumab + docetaxel (group D)","n":96,"value":24},{"name":"Pertuzumab + trastuzumab, no chemotherapy (group C)","n":107,"value":16.8}],"p":"0.0141 (group B vs group A)","source":"https://doi.org/10.1016/s1470-2045(11)70336-9"}]},{"id":"neotorch","kind":"trial","name":"Neotorch","aka":["NEOTORCH"],"tldr":"A Chinese trial showing that adding the PD-1 antibody toripalimab to chemotherapy before and after lung cancer surgery more than doubles the time before the cancer comes back.","summary":"Neotorch enrolled 501 patients with resectable stage II or III non-small-cell lung cancer at 50 hospitals in China between March 2020 and June 2023, randomising them 1:1 to toripalimab or placebo with platinum-based chemotherapy for three cycles before surgery and one after, followed by toripalimab or placebo alone for up to 13 cycles. Non-squamous tumours had to be free of EGFR and ALK alterations. The dual primary endpoints were investigator-assessed event-free survival and blinded independently reviewed major pathological response.\n\nThe interim analysis, with a data cutoff of 30 November 2022, reported the 404 stage III patients (202 in each arm); the 97 stage II patients were excluded from it. Median age was 62, 92 percent were male and median follow-up was 18.3 months. Median event-free survival was not estimable (95 percent confidence interval 24.4 months to not estimable) with toripalimab against 15.1 months (10.6 to 21.9) with placebo, a hazard ratio of 0.40 (0.28 to 0.57).\n\nNeotorch is one of four perioperative trials, with KEYNOTE-671, AEGEAN and CheckMate 77T, that made chemotherapy plus a checkpoint inhibitor before and after surgery a standard for stage II to III disease. Its population is almost entirely Chinese and male, which limits how far it transfers.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04158440","url":"https://clinicaltrials.gov/study/NCT04158440"},{"label":"Neotorch (JAMA 2024)","url":"https://doi.org/10.1001/jama.2023.24735"}],"tags":[],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":["pd1"],"drugs":["toripalimab","cisplatin","carboplatin"],"companies":["junshi"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","major-pathological-response","pcr"],"trials":["keynote-671","nct03800134","nct04025879","nct04379635"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04158440","phase":"3","setting":"Resectable stage II or III non-small-cell lung cancer in China, without EGFR or ALK alterations for non-squamous disease: toripalimab 240 mg or placebo every three weeks with platinum chemotherapy for three cycles before surgery and one after, then toripalimab or placebo alone for up to 13 cycles, with dual primary endpoints of event-free survival and major pathological response","sponsor":"Shanghai Junshi Biosciences","result":"Median event-free survival not estimable against 15.1 months in stage III disease (hazard ratio 0.40, 95 percent confidence interval 0.28 to 0.57).","started":"2020-04-07","startedType":"actual","yearReported":2024,"enrolled":501,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival (stage III population)","primary":true,"unit":"months","arms":[{"name":"Toripalimab with chemotherapy","n":202,"note":"median not estimable (95 percent confidence interval 24.4 to not estimable)"},{"name":"Placebo with chemotherapy","n":202,"value":15.1}],"hr":0.4,"ci":[0.28,0.57],"source":"https://doi.org/10.1001/jama.2023.24735"}],"replication":"RATIONALE-315 (tislelizumab), CheckMate 77T (nivolumab), KEYNOTE-671 (pembrolizumab) and AEGEAN (durvalumab) all found the same direction of effect with the same design."},{"id":"neotrip","kind":"trial","name":"NeoTRIP (NeoTRIPaPDL1)","aka":["NeoTRIPaPDL1","NeoTRIP Michelangelo"],"tldr":"NeoTRIP added the immunotherapy atezolizumab to platinum chemotherapy before surgery without anthracyclines and did not significantly increase the share of women whose tumour disappeared (49 versus 44 percent); its main endpoint, whether fewer women relapse, is still awaited.","summary":"NeoTRIP (NCT02620280) randomised 280 patients (278 in the registry) with triple-negative early high-risk or locally advanced breast cancer to neoadjuvant carboplatin AUC 2 and nab-paclitaxel 125 mg/m2 on days 1 and 8 every 3 weeks for eight cycles with or without atezolizumab 1,200 mg, followed by four cycles of adjuvant anthracycline. The primary endpoint is event-free survival; pathological complete response, a key secondary endpoint, was 48.6 percent with atezolizumab and 44.4 percent without (odds ratio 1.18, 0.74 to 1.89, p 0.48). Serious adverse events and liver transaminase abnormalities were more frequent with atezolizumab. PD-L1 expression was the strongest predictor of pathological complete response (odds ratio 2.08). The trial is unusual in omitting anthracyclines from the neoadjuvant phase, which is one explanation offered for the smaller immunotherapy effect than in KEYNOTE-522 and IMpassion031; event-free survival follow-up continues and no primary result was indexed in September 2026.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02620280","url":"https://clinicaltrials.gov/study/NCT02620280"},{"label":"Gianni et al., Annals of Oncology 2022: NeoTRIP pathological complete response","url":"https://doi.org/10.1016/j.annonc.2022.02.004"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","platinum","cytotoxic-chemotherapy"],"targets":[],"drugs":["atezolizumab","carboplatin","nab-paclitaxel"],"companies":[],"institutions":["fondazione-michelangelo"],"pathways":[],"terms":["pcr","efs"],"trials":["impassion031","keynote-522","gepardouze"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02620280","phase":"3","setting":"Early high-risk or locally advanced triple-negative breast cancer: neoadjuvant carboplatin and nab-paclitaxel with or without atezolizumab for eight cycles, then adjuvant anthracycline, Europe and Taiwan","sponsor":"Fondazione Michelangelo","result":"pCR 48.6% vs 44.4% (OR 1.18, p 0.48), not significant; EFS (primary) awaited.","started":"2016-04","yearReported":2022,"enrolled":278,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathological complete response (breast and nodes)","unit":"%","arms":[{"name":"Carboplatin + nab-paclitaxel + atezolizumab","n":138,"value":48.6},{"name":"Carboplatin + nab-paclitaxel","n":142,"value":44.4}],"p":"0.48 (odds ratio 1.18, 0.74 to 1.89; event-free survival is the primary endpoint)","source":"https://doi.org/10.1016/j.annonc.2022.02.004"}],"replication":"Contrasts with KEYNOTE-522 and IMpassion031, which used anthracycline-containing backbones and showed pCR gains with checkpoint inhibition."},{"id":"netherlands-hipec","kind":"trial","name":"Netherlands Cancer Institute HIPEC trial","aka":["Verwaal trial"],"tldr":"The trial that made cytoreductive surgery with a heated chemotherapy wash a treatment rather than an experiment. Twenty years later PRODIGE 7 showed the surgery, not the wash, was doing the work.","summary":"Verwaal and colleagues at the Netherlands Cancer Institute randomised 105 patients with peritoneal carcinomatosis of colorectal origin to cytoreductive surgery with mitomycin C hyperthermic intraperitoneal chemotherapy followed by systemic fluorouracil and leucovorin, or to systemic fluorouracil and leucovorin with palliative surgery when needed. Median survival was 22.3 against 12.6 months (p=0.032) after a median 21.6 months of follow-up. Treatment-related mortality in the aggressive arm was 8 percent, most complications coming from bowel leakage, and patients with six or seven of the seven abdominal regions involved, or an incomplete cytoreduction, did badly. This trial created the specialist peritoneal surface malignancy services that exist today. PRODIGE 7 later showed that oxaliplatin HIPEC adds nothing to complete cytoreduction, so what this trial really demonstrated is the value of the operation and of selecting patients with limited disease.","status":"positive","asOf":"2026-09-24","links":[{"label":"Verwaal: randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy in peritoneal carcinomatosis of colorectal cancer (Journal of Clinical Oncology 2003)","url":"https://doi.org/10.1200/JCO.2003.04.187"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["hipec","hipec-pipac-devices"],"targets":[],"drugs":["mitomycin","fluorouracil","leucovorin"],"companies":[],"institutions":["nki"],"pathways":[],"terms":["debulking"],"trials":["prodige-7","colopec","prophylochip"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Peritoneal carcinomatosis from colorectal cancer: cytoreductive surgery with mitomycin C hyperthermic intraperitoneal chemotherapy and systemic fluorouracil and leucovorin, against systemic fluorouracil and leucovorin with or without palliative surgery","sponsor":"Netherlands Cancer Institute","result":"Median survival 22.3 against 12.6 months (p=0.032), with 8 percent treatment-related mortality.","yearReported":2003,"enrolled":105,"enrolledBasis":"randomised","enrolledNote":"105 patients were randomised between 1998 and 2001; the trial predates the registries.","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Cytoreductive surgery plus mitomycin HIPEC and systemic chemotherapy","value":22.3},{"name":"Systemic chemotherapy with or without palliative surgery","value":12.6}],"p":"0.032","source":"https://doi.org/10.1200/JCO.2003.04.187"}],"replication":"PRODIGE 7 found no survival gain from adding oxaliplatin HIPEC to complete cytoreduction (41.7 against 41.2 months), and COLOPEC and PROPHYLOCHIP were negative as prophylaxis."},{"id":"netter-1","kind":"trial","name":"NETTER-1","aka":[],"tldr":"The trial that made radioligand therapy a standard: a radioactive drug homing to the somatostatin receptor held midgut neuroendocrine tumours in check far longer than high-dose octreotide, and it underpins Lutathera's approvals.","summary":"NETTER-1, trial NCT01578239 sponsored by Advanced Accelerator Applications and published in the New England Journal of Medicine in 2017, randomised 231 patients with inoperable, progressive, somatostatin receptor-positive midgut neuroendocrine tumours to 177Lu-Dotatate (four cycles, with octreotide) or high-dose octreotide LAR. Progression-free survival at 20 months was 65.2% with 177Lu-Dotatate against 10.8% with octreotide, and the response rate was 18% against 3%. The result supported the 2018 US and EU approvals of Lutathera and made peptide receptor radionuclide therapy the reference treatment after somatostatin analogues.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT01578239","url":"https://clinicaltrials.gov/study/NCT01578239"},{"label":"Strosberg et al., Phase 3 trial of 177Lu-Dotatate for midgut neuroendocrine tumours (NEJM 2017)","url":"https://doi.org/10.1056/NEJMoa1607427"}],"tags":[],"related":[],"cancers":["neuroendocrine","small-intestinal-net"],"sections":[],"technologies":["prrt"],"targets":["sstr2"],"drugs":["lutathera","octreotide-lanreotide"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01578239","phase":"3","setting":"Inoperable, progressive midgut neuroendocrine tumours: 177Lu-Dotatate plus octreotide versus high-dose octreotide LAR","sponsor":"Advanced Accelerator Applications (Novartis)","result":"PFS at 20 months 65.2% vs 10.8% (HR 0.21); ORR 18% vs 3%.","started":"2012-09-06","startedType":"actual","yearReported":2017,"enrolled":231,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 20 months","primary":true,"unit":"%","arms":[{"name":"177Lu-Dotatate + octreotide","n":116,"value":65.2},{"name":"High-dose octreotide LAR","n":113,"value":10.8}],"hr":0.21,"ci":[0.13,0.33],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1607427"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"177Lu-Dotatate + octreotide","n":116,"value":18},{"name":"High-dose octreotide LAR","n":113,"value":3}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1607427"}]},{"id":"nct03252431","kind":"trial","name":"Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy","aka":[],"tldr":"A phase 3 trial of Efbemalenograstim alfa and Pegfilgrastim in Breast cancer, run by EVIVE Biotechnology, completed.","summary":"Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy is a phase 3 interventional study registered as NCT03252431 by EVIVE Biotechnology, with 393 participants recorded, started 2018-04-12 and reaching its primary completion in 2019-09-25. Interventions recorded: F-627, Neulasta. Conditions recorded: Breast Cancer, Neutropenia.\n\nLinked to the drug Efbemalenograstim alfa because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03252431","url":"https://clinicaltrials.gov/study/NCT03252431"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer","male-breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["efbemalenograstim-alfa","pegfilgrastim"],"companies":["evive-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03252431","phase":"3","setting":"A Phase III, Randomized, Multi-Centre, Open-Label, Fixed Dose, Neulasta® Active-Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy","sponsor":"EVIVE Biotechnology","started":"2018-04-12","startedType":"actual","yearReported":2021,"enrolled":393,"enrolledBasis":"registry","outcomes":[{"endpoint":"Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1","primary":true,"unit":"days","arms":[{"name":"F-627","n":197,"value":0.2,"note":"SD 0.51; Figures from the ClinicalTrials.gov results section (first posted 2021-05-07), not from a publication"},{"name":"Neulasta","n":196,"value":0.2,"note":"SD 0.45"}],"source":"https://clinicaltrials.gov/study/NCT03252431?tab=results"}]},{"id":"nct07504198","kind":"trial","name":"Neuroprotection of Memantine and Rosuvastatin","aka":[],"tldr":"A phase 2/3 trial of memantine in colorectal cancer, run by Tanta University, not yet recruiting.","summary":"Neuroprotection of Memantine and Rosuvastatin is a phase 2/3, randomised interventional study registered as NCT07504198 by Tanta University, with a registry enrolment figure of 46 participants, started 2026-03 and due to reach its primary completion in 2027-04. Interventions recorded: Starch Placebo; Memantine; Rosuvastatin 20 Mg Oral Tablet. Conditions listed: Peripheral Nerve Disease. Primary outcome: The primary outcome is the percentage of patients with sensory neuropathy grade ≥ 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events for grading of neuropathy from 1 to 5 based on severity.. Colorectal eligibility wording from the registry: \"* Patients with histologically confirmed diagnosis of stage III or stage IV colorectal cancer\". Sites: Egypt. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07504198","url":"https://clinicaltrials.gov/study/NCT07504198"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["memantine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07504198","phase":"2/3","setting":"Neuroprotective Effect of Memantine and Rosuvastatin Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer","sponsor":"Tanta University","started":"2026-03","startedType":"estimated","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04564157","kind":"trial","name":"New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy","aka":["NADIM-ADJUVANT"],"tldr":"A phase 3 trial of carboplatin, paclitaxel / nab-paclitaxel and nivolumab in lung cancer, run by Fundación GECP, active but no longer recruiting.","summary":"New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy is a phase 3, randomised interventional study registered as NCT04564157 by Fundación GECP, with a registry enrolment figure of 210 participants, started 2021-01-13 and due to reach its primary completion in 2030-04-01. Interventions recorded: Carboplatin; Paclitaxel; Nivolumab. Conditions listed: Non-Small Cell Lung Cancer; Adjuvant Chemotherapy. Primary outcome: The disease-free survival. Lung eligibility wording from the registry: \"Patients diagnosed of primary non-small cell lung cancer, histologically confirmed\". Sites: Spain. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04564157","url":"https://clinicaltrials.gov/study/NCT04564157"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","paclitaxel","nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04564157","phase":"3","setting":"A Phase III Clinical Trial of Adjuvant Chemotherapy vs Chemoimmunotherapy for Stage IB-IIIA Completely Resected Non-small Cell Lung Cancer (NSCLC) Patients.","sponsor":"Fundación GECP","started":"2021-01-13","startedType":"actual","enrolled":210,"enrolledBasis":"registry","outcomes":[]},{"id":"new-epoc","kind":"trial","name":"New EPOC","aka":[],"tldr":"Adding the EGFR antibody around liver surgery shortened life by more than two years. It is the clearest warning in bowel cancer that a drug that helps in advanced disease can harm in the curative setting.","summary":"New EPOC randomised 257 patients with KRAS wild-type (codons 12, 13 and 61) resectable or suboptimally resectable colorectal liver metastases to perioperative oxaliplatin-based chemotherapy with or without cetuximab. At a median 66.7 months, progression-free survival was 22.2 months without cetuximab against 15.5 months with it (hazard ratio 1.17, 95% CI 0.87 to 1.56, p=0.304) and median overall survival 81.0 against 55.4 months (hazard ratio 1.45, 1.02 to 2.05, p=0.036). There was no difference in preoperative response or in resection status. Four of the five possibly treatment-related deaths were in the cetuximab group. The mechanism of the harm has never been explained. New EPOC is why anti-EGFR antibodies are not given around liver resection even in the patients they help most in advanced disease.","status":"negative","asOf":"2026-09-24","links":[{"label":"New EPOC: systemic chemotherapy with or without cetuximab in resectable colorectal liver metastasis, long-term results (Lancet Oncology 2020)","url":"https://doi.org/10.1016/S1470-2045(19)30798-3"},{"label":"ISRCTN22944367","url":"https://www.isrctn.com/ISRCTN22944367"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["monoclonal-antibody","cytotoxic-chemotherapy"],"targets":["egfr","kras"],"drugs":["cetuximab","folfox","capox","oxaliplatin"],"companies":[],"institutions":["birmingham-cancer-centre"],"pathways":[],"terms":["hepatectomy","oligometastatic"],"trials":["eortc-40983"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN22944367","phase":"3","setting":"KRAS wild-type resectable or suboptimally resectable colorectal liver metastases: perioperative chemotherapy with or without cetuximab","sponsor":"University of Birmingham / Cancer Research UK","result":"Median overall survival 55.4 months with cetuximab against 81.0 months without (hazard ratio 1.45).","yearReported":2020,"enrolled":257,"enrolledBasis":"randomised","enrolledNote":"257 eligible patients were randomised; the trial is registered as ISRCTN22944367 and has no NCT number.","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Chemotherapy plus cetuximab","n":129,"value":55.4},{"name":"Chemotherapy alone","n":128,"value":81}],"hr":1.45,"ci":[1.02,2.05],"p":"0.036","source":"https://doi.org/10.1016/S1470-2045(19)30798-3"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Chemotherapy plus cetuximab","value":15.5},{"name":"Chemotherapy alone","value":22.2}],"hr":1.17,"ci":[0.87,1.56],"p":"0.304","source":"https://doi.org/10.1016/S1470-2045(19)30798-3"}]},{"id":"nct07559760","kind":"trial","name":"New Second-Line Combo Therapy for MSS Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of bevacizumab (glioblastoma use) in colorectal cancer, run by The First Hospital of Jilin University, now recruiting.","summary":"New Second-Line Combo Therapy for MSS Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT07559760 by The First Hospital of Jilin University, with a registry enrolment figure of 30 participants, started 2025-11-01 and due to reach its primary completion in 2027-05-31. Interventions recorded: Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: mPFS. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07559760","url":"https://clinicaltrials.gov/study/NCT07559760"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07559760","phase":"2","setting":"A Prospective Study of Levoleucovorin/5-FU Co-Infusion Combined With Liposomal Irinotecan ±Cetuximab/Bevacizumab as Second-Line Therapy for MSS Metastatic Colorectal Cancer","sponsor":"The First Hospital of Jilin University","started":"2025-11-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06370754","kind":"trial","name":"Newly Emerging Immunotherapy for Pancreatic Cancer Treatment","aka":["FD-IMPACT"],"tldr":"A phase 1/2 trial of liposomal irinotecan, fluorouracil (5-FU), fLOT (5-FU, leucovorin, oxaliplatin, docetaxel), nab-paclitaxel and other drugs in pancreatic cancer, run by Fudan University, not yet recruiting.","summary":"Newly Emerging Immunotherapy for Pancreatic Cancer Treatment is a phase 1/2, interventional study registered as NCT06370754 by Fudan University, with a registry enrolment figure of 117 participants, started 2024-04-30 and due to reach its primary completion in 2026-04-30. Interventions recorded: JS001; JS004; JS007; JS015; Irinotecan Liposome Injection; 5-Fluorouracil (5-FU); Leucovorin (LV); Nab paclitaxel; Gemcitabine. Conditions listed: Pancreatic Cancer. Primary outcome: Incidence of dose-limiting toxicity (DLT) (phase IB); Objective Response Rate (ORR) (phase II). Pancreatic eligibility wording from the registry: \"* Patients with locally advanced unresectable or metastatic pancreatic cancer confirmed by histopathology or cytopathology (islet cell tumor is not eligible for inclusion) who meet the following requirements:\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06370754","url":"https://clinicaltrials.gov/study/NCT06370754"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["liposomal-irinotecan","fluorouracil","flot","nab-paclitaxel","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06370754","phase":"1/2","setting":"A Phase Ib/II Platform Trial of Newly Emerging Immunotherapy for Pancreatic Cancer Treatment","sponsor":"Fudan University","started":"2024-04-30","startedType":"estimated","enrolled":117,"enrolledBasis":"registry","outcomes":[]},{"id":"nhs-galleri","kind":"trial","name":"NHS-Galleri","aka":["NHS-Galleri trial"],"tldr":"The largest cancer screening trial ever run, testing whether a multi-cancer blood test reduces late-stage diagnoses; it reports that it did not, and its test-performance paper appeared in Nature Medicine on 22 September 2026.","summary":"NHS-Galleri (ISRCTN91431511; ClinicalTrials.gov NCT05611632) randomised 142,250 people aged 50 to 77 in England 1:1 to GRAIL's Galleri multi-cancer early detection (MCED) test added to usual NHS care, or to control, with three annual screening rounds; positive results were referred to NHS standard-of-care diagnostic pathways informed by the predicted cancer signal origin. The primary endpoint was a reduction in the incidence of stage III/IV cancer diagnoses in the intervention arm versus control, tested first in 12 prespecified cancer types (lung, head and neck, colorectal, pancreas, myeloma or plasma cell neoplasm, liver or bile duct, stomach, oesophagus, anus, lymphoma, ovary and bladder).\n\nThe test-performance paper in Nature Medicine (22 September 2026) states that the primary endpoint was not met and was reported elsewhere; no peer-reviewed primary-endpoint paper was indexed on Europe PMC by 23 September 2026, so the primary result rests on that statement and on GRAIL's 30 May 2026 release. The paper's own figures, for the intervention arm: positive results in 1.03, 0.80 and 0.90 percent of participants in rounds 1 to 3; 937 MCED-detected primary cancers in aggregate; cancer detection rates 0.60, 0.40 and 0.41 percent; positive predictive values 58.0, 50.4 and 45.8 percent; negative predictive values 98.98, 98.90 and 98.86 percent; specificity 99.50 to 99.60 percent; episode sensitivity 26.7 to 37.2 percent for all cancers and 47.6 to 63.4 percent for the 12 prespecified types.\n\nThe registry lists the trial as active, not recruiting, with 142,318 participants, primary completion on 12 June 2026 and study completion in January 2031 for longer follow-up including cancer-specific mortality. The data feed GRAIL's FDA premarket approval application and the advisory committee of 23 September 2026.","status":"active","asOf":"2026-09-04","links":[{"label":"ISRCTN91431511","url":"https://www.isrctn.com/ISRCTN91431511"},{"label":"ClinicalTrials.gov NCT05611632","url":"https://clinicaltrials.gov/study/NCT05611632"},{"label":"Nature Medicine 2026: test performance across three rounds","url":"https://doi.org/10.1038/s41591-026-04652-8"},{"label":"NHS-Galleri","url":"https://www.nhs-galleri.org"}],"tags":[],"related":[],"cancers":["lung-cancer","head-and-neck","colorectal","pancreatic","multiple-myeloma","hcc","cholangiocarcinoma","gastric","esophageal","anal","hodgkin-lymphoma","non-hodgkin-lymphoma","ovarian","urothelial"],"sections":[],"technologies":["mced","cfdna-methylation-testing","methylation-profiling"],"targets":[],"drugs":["galleri"],"companies":["grail"],"institutions":[],"pathways":[],"terms":["stage-shift","ppv","screening"],"trials":[],"people":["peter-sasieni","charles-swanton","peter-johnson","eric-klein","deb-schrag"],"bottlenecks":[],"keyPapers":["paper-nhs-galleri-performance-nat-med-2026","paper-nhs-galleri-design-cancers-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05611632","phase":"3","setting":"142,250 asymptomatic adults aged 50 to 77 in England, randomised 1:1 to three annual rounds of the Galleri multi-cancer early detection blood test added to usual NHS care, or to blood draws stored without results","sponsor":"GRAIL, Inc. (lead sponsor on the registry) with NHS England and the Cancer Research UK Cancer Prevention Trials Unit at Queen Mary University of London","started":"2021-08-31","startedType":"actual","yearReported":2026,"enrolled":142250,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov NCT05611632 and ISRCTN91431511 list 142,318 participants (actual); the Nature Medicine test-performance paper reports 142,250 participants randomised 1:1.","outcomes":[{"endpoint":"Stage III to IV incidence, 12 prespecified cancers (primary)","primary":true,"arms":[{"name":"Galleri + usual NHS care","note":"Not met, per the Nature Medicine test-performance paper (22 September 2026), which states the primary endpoint was not met and reported elsewhere; no peer-reviewed primary-endpoint paper was on Europe PMC by 23 September 2026, so no figures are recorded here."},{"name":"Usual NHS care"}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Positive test results by screening round","unit":"%","arms":[{"name":"Round 1","n":70325,"value":1.03,"note":"722, 518 and 561 positive results among evaluable intervention-arm participants"},{"name":"Round 2","n":64498,"value":0.8},{"name":"Round 3","n":62323,"value":0.9}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Cancer detection rate by screening round","unit":"%","arms":[{"name":"Round 1","n":70325,"value":0.6,"note":"937 participants had MCED-detected primary cancers across the three rounds"},{"name":"Round 2","n":64498,"value":0.4},{"name":"Round 3","n":62323,"value":0.41}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Positive predictive value by screening round","unit":"%","arms":[{"name":"Round 1","n":722,"value":58,"note":"419/722, 261/518 and 257/561"},{"name":"Round 2","n":518,"value":50.4},{"name":"Round 3","n":561,"value":45.8}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Negative predictive value by screening round","unit":"%","arms":[{"name":"Round 1","n":69603,"value":98.98,"note":"68,895/69,603, 63,278/63,980 and 61,058/61,762"},{"name":"Round 2","n":63980,"value":98.9},{"name":"Round 3","n":61762,"value":98.86}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Specificity, range across rounds","unit":"%","arms":[{"name":"Lowest round","value":99.5,"note":"The abstract gives the range across rounds 1 to 3, not per-round values"},{"name":"Highest round","value":99.6}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Episode sensitivity, all cancers, range across rounds","unit":"%","arms":[{"name":"Lowest round","value":26.7,"note":"Range across rounds 1 to 3 as given in the abstract"},{"name":"Highest round","value":37.2}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Episode sensitivity, 12 prespecified cancer types, range across rounds","unit":"%","arms":[{"name":"Lowest round","value":47.6,"note":"Range across rounds 1 to 3 as given in the abstract"},{"name":"Highest round","value":63.4}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Cancer signal origin accuracy, range across rounds","unit":"%","arms":[{"name":"Lowest round","value":91.1},{"name":"Highest round","value":93.6}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Relative reduction in stage IV diagnoses, rounds 2 and 3","unit":"%","arms":[{"name":"Round 2","value":22,"note":"Relative reduction versus control in the 12 prespecified cancers, from GRAIL's release of 30 May 2026; not in the Nature Medicine paper"},{"name":"Round 3","value":26}],"source":"https://grail.com/press-releases/grail-reports-full-results-from-nhs-galleri-trial-demonstrating-substantial-reduction-in-stage-iv-cancer-diagnoses-at-2026-asco-annual-meeting/"},{"endpoint":"Relative reduction in diagnosis through emergency presentation","unit":"%","arms":[{"name":"Galleri + standard screening","value":25,"note":"From GRAIL's release of 30 May 2026; not in the Nature Medicine paper"}],"source":"https://grail.com/press-releases/grail-reports-full-results-from-nhs-galleri-trial-demonstrating-substantial-reduction-in-stage-iv-cancer-diagnoses-at-2026-asco-annual-meeting/"}],"replication":"The only randomised MCED trial; PATHFINDER 2 (single-arm) is consistent on detection rate and positive predictive value. The primary-endpoint paper had not appeared by 23 September 2026 and mortality follow-up runs to January 2031 on the registry."},{"id":"niagara","kind":"trial","name":"NIAGARA","aka":[],"tldr":"The first immunotherapy shown to improve survival when given around bladder-removal surgery.","summary":"NIAGARA, trial NCT03732677 sponsored by AstraZeneca and reported in 2024, was the first trial to show that immunotherapy given around bladder-removal surgery improves survival. It randomised 1,063 cisplatin-eligible patients with muscle-invasive bladder cancer to neoadjuvant durvalumab plus gemcitabine and cisplatin, cystectomy and adjuvant durvalumab, or neoadjuvant chemotherapy and cystectomy, met its primary event-free survival endpoint, improved overall survival and raised the pathologic complete response rate, leading to FDA approval on 28 March 2025 as the first perioperative immunotherapy in this disease. OnCo links it to bladder cancer, durvalumab, the perioperative, MIBC and radical cystectomy terms and Thomas Powles. It sets a new baseline that EV-304 now challenges, and which regimen wins is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03732677","url":"https://clinicaltrials.gov/study/NCT03732677"},{"label":"FDA approval (Mar 2025)","url":"https://www.urologytimes.com/view/fda-approves-durvalumab-chemo-for-muscle-invasive-bladder-cancer"}],"tags":[],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","nmibc-vs-mibc"],"trials":[],"people":["thomas-powles"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03732677","phase":"3","setting":"Cisplatin-eligible muscle-invasive bladder cancer: neoadjuvant durvalumab + gemcitabine-cisplatin, cystectomy, adjuvant durvalumab vs neoadjuvant chemotherapy and cystectomy","sponsor":"AstraZeneca","result":"EFS HR 0.68; OS HR 0.75.","started":"2018-11-16","startedType":"actual","yearReported":2024,"enrolled":1063,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival","primary":true,"unit":"months","arms":[{"name":"Durvalumab + chemo, perioperative","n":533,"note":"median not reached"},{"name":"Chemo + cystectomy","n":530,"value":46.1}],"hr":0.68,"ci":[0.56,0.82],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2408154"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Durvalumab arm","note":"not reached"},{"name":"Control","note":"not reached"}],"hr":0.75,"ci":[0.59,0.93],"p":"0.01","source":"https://doi.org/10.1056/NEJMoa2408154"}],"replication":"Perioperative IO benefit replicated in principle by EV-303 and EV-304 (with an ADC partner) and by adjuvant CheckMate 274."},{"id":"niche-2","kind":"trial","name":"NICHE-2","aka":[],"tldr":"In NICHE-2, four weeks of immunotherapy before surgery wiped out most mismatch-repair-deficient colon cancers, and nobody had relapsed three years later.","summary":"Pathologic response in 98%, major pathologic response 95%, pathologic complete response 68% (NEJM 2024). Three-year disease-free survival 100% (ESMO 2024). No patient needed chemotherapy. NICHE-3 (nivolumab + relatlimab) and the ATOMIC adjuvant trial extend the evidence; organ-preservation trials in rectal cancer (AZUR-1) follow the same logic.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03026140","url":"https://clinicaltrials.gov/study/NCT03026140"},{"label":"NEJM 2024","url":"https://www.nejm.org/doi/abs/10.1056/NEJMoa2400634"}],"tags":[],"related":[],"cancers":["colorectal","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":[],"institutions":["nki"],"pathways":[],"terms":["msi","neoadjuvant-adjuvant","pcr"],"trials":["nct05855200","foxtrot"],"people":["myriam-chalabi"],"bottlenecks":[],"keyPapers":["paper-le-mmr-deficiency-pd1-nejm-2015","paper-moreira-lynch-syndrome-identification-jama-2012","paper-niche-2-nat-med-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03026140","phase":"2","setting":"Locally advanced (mostly stage III) dMMR colon cancer: 4 weeks of neoadjuvant nivolumab + one dose ipilimumab, then surgery","sponsor":"Netherlands Cancer Institute","result":"pCR 68%, major pathologic response 95%; 3-year DFS 100%.","started":"2017-03-29","startedType":"actual","yearReported":2022,"enrolled":115,"enrolledBasis":"registered","enrolledNote":"ClinicalTrials.gov lists an estimated 353 participants for the amended NICHE protocol, which is still recruiting to further cohorts; the NEJM 2024 NICHE-2 analysis enrolled 115 patients, 111 of them in the efficacy analysis.","outcomes":[{"endpoint":"Pathologic complete response","primary":true,"unit":"percent","arms":[{"name":"Neoadjuvant nivolumab + ipilimumab","n":111,"value":68}],"source":"https://www.nejm.org/doi/abs/10.1056/NEJMoa2400634"},{"endpoint":"3-year disease-free survival","unit":"percent","arms":[{"name":"Neoadjuvant nivolumab + ipilimumab","n":111,"value":100}],"source":"https://www.annalsofoncology.org/article/S0923-7534(24)03843-2/fulltext"}],"replication":"Single-arm; the ATOMIC phase 3 (adjuvant atezolizumab) and NICHE-3 corroborate dMMR immunotherapy benefit in the curative setting, but no randomised neoadjuvant trial has yet reported."},{"id":"nife","kind":"trial","name":"NIFE (AIO-YMO HEP-0315)","aka":["NIFE"],"tldr":"The German NIFE trial gave liposomal irinotecan with fluorouracil as a first treatment for bile duct and gallbladder cancer alongside a standard gemcitabine and cisplatin arm, each judged on its own by the share of patients free of progression at four months. It completed with 93 patients.","summary":"NIFE (NCT03044587) was an interventional, prospective, randomised, open-label two-sided phase 2 designed with a Simon two-stage design in each arm: nal-IRI 80 mg/m², fluorouracil 2,400 mg/m² and leucovorin 400 mg/m² every 14 days (arm A) versus cisplatin 25 mg/m² and gemcitabine 1,000 mg/m² days 1 and 8 every 21 days (arm B), analysed unconnected. Randomisation was stratified by tumour site (intrahepatic versus extrahepatic biliary tract), stage, age, sex and performance status. The primary endpoint was the progression-free survival rate at four months in each arm, with overall progression-free survival, three-year survival, disease control at two months, safety and quality of life as secondary endpoints. The registry records 93 patients enrolled at German sites, primary completion in January 2022 and study completion in January 2025. A primary results paper was not found in Europe PMC in September 2026; only the protocol is indexed. It sits between NIFTY (positive, second line) and NALIRICC (negative, second line) in the liposomal irinotecan story.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03044587","url":"https://clinicaltrials.gov/study/NCT03044587"},{"label":"Perkhofer et al., BMC Cancer 2019: NIFE protocol","url":"https://doi.org/10.1186/s12885-019-6142-y"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["liposomal-irinotecan","fluorouracil","leucovorin","gemcitabine-cisplatin"],"companies":["aio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03044587","phase":"2","setting":"First-line advanced biliary tract cancer: liposomal irinotecan with fluorouracil and leucovorin (arm A) or gemcitabine and cisplatin (arm B), open-label non-comparative randomised phase 2","sponsor":"AIO-Studien-gGmbH","started":"2018-01-24","startedType":"actual","enrolled":93,"enrolledBasis":"registry","outcomes":[]},{"id":"nifty","kind":"trial","name":"NIFTY","aka":[],"tldr":"A Korean trial found that adding liposomal irinotecan to fluorouracil as second-line chemotherapy for bile duct and gallbladder cancer delayed progression, from about six weeks to four months on the re-read scans, at the cost of more neutropenia. A German trial of the same idea was negative, so it is an option rather than a standard, and it is not commissioned in the UK.","summary":"NIFTY (NCT03524508) randomised 178 patients (174 in the full analysis set: 88 to liposomal irinotecan 70 mg/m² plus leucovorin 400 mg/m² and fluorouracil 2,400 mg/m² every two weeks, 86 to fluorouracil and leucovorin alone) with metastatic biliary tract cancer that had progressed on first-line gemcitabine and cisplatin, stratified by primary tumour site. At the primary analysis (median follow-up 11.8 months) blinded independent central review progression-free survival was 7.1 versus 1.4 months (hazard ratio 0.56, 95 percent confidence interval 0.39 to 0.81, p 0.0019). With extended follow-up and a re-performed masked central review by three new radiologists, the medians fell to 4.2 versus 1.7 months (hazard ratio 0.61, 0.44 to 0.86, p 0.004), a discordance the authors attributed to reader variation. Grade 3 to 4 neutropenia occurred in 24 versus 1 percent and serious adverse events in 42 versus 24 percent, with no treatment-related deaths. The German NALIRICC trial did not reproduce the benefit, though a pooled analysis modestly favoured the combination. NCCN lists the regimen as a second-line option; in the UK FOLFOX from ABC-06 is the commissioned second-line regimen and liposomal irinotecan is licensed only for pancreatic cancer.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03524508","url":"https://clinicaltrials.gov/study/NCT03524508"},{"label":"Yoo et al., Lancet Oncology 2021: NIFTY","url":"https://doi.org/10.1016/S1470-2045(21)00486-1"},{"label":"Hyung et al., JAMA Oncology 2023: NIFTY updated analysis","url":"https://doi.org/10.1001/jamaoncol.2023.0016"}],"tags":["lesson:replication"],"related":["naliricc","abc-06"],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["liposomal-irinotecan","fluorouracil","leucovorin"],"companies":[],"institutions":["asan-medical-center"],"pathways":[],"terms":[],"trials":[],"people":["ghassan-abou-alfa"],"bottlenecks":[],"keyPapers":["paper-nifty-liposomal-irinotecan-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":["Key figures: 178 randomised (174 analysed, 88 versus 86); blinded central review progression-free survival 7.1 versus 1.4 months (hazard ratio 0.56, 0.39 to 0.81, p 0.0019) at the primary analysis and 4.2 versus 1.7 months (hazard ratio 0.61, 0.44 to 0.86, p 0.004) on the re-read with extended follow-up; grade 3 to 4 neutropenia 24 versus 1 percent; serious adverse events 42 versus 24 percent; no treatment-related deaths. Not reproduced by NALIRICC. Liposomal irinotecan is not commissioned for biliary cancer in the UK, where FOLFOX (ABC-06) is the second-line standard."],"nct":"NCT03524508","phase":"2","setting":"Metastatic biliary tract cancer after progression on gemcitabine and cisplatin: fluorouracil and leucovorin with or without liposomal irinotecan, open-label randomised phase 2b at five Korean centres","sponsor":"Asan Medical Center (Changhoon Yoo)","result":"BICR PFS 7.1 vs 1.4 months, HR 0.56 (0.39 to 0.81), p=0.0019; re-read PFS 4.2 vs 1.7 months, HR 0.61 (0.44 to 0.86).","started":"2018-09-04","startedType":"actual","yearReported":2021,"enrolled":178,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival by masked independent central review (updated, re-read)","unit":"months","arms":[{"name":"Liposomal irinotecan + 5-FU/LV","n":88,"value":4.2},{"name":"5-FU/LV","n":86,"value":1.7}],"hr":0.61,"ci":[0.44,0.86],"p":"0.004","source":"https://doi.org/10.1001/jamaoncol.2023.0016"},{"endpoint":"Grade 3-4 neutropenia","unit":"%","arms":[{"name":"Liposomal irinotecan + 5-FU/LV","n":88,"value":24},{"name":"5-FU/LV","n":86,"value":1}],"source":"https://doi.org/10.1016/S1470-2045(21)00486-1"}],"replication":"Not reproduced by the German NALIRICC phase 2 (2024); a 2025 pooled analysis modestly favoured the combination."},{"id":"nct07677579","kind":"trial","name":"NIMBLE-CRC: NeoImmunoModulation Before Leveraging Excision in Colorectal Rectal Cancer","aka":["NIMBLE"],"tldr":"A phase 2 trial of retifanlimab and zanzalintinib in colorectal cancer, run by Northwell Health, not yet recruiting.","summary":"NIMBLE-CRC: NeoImmunoModulation Before Leveraging Excision in Colorectal Rectal Cancer is a phase 2, interventional study registered as NCT07677579 by Northwell Health, with a registry enrolment figure of 26 participants, started 2026-08-30 and due to reach its primary completion in 2028-08-30. Interventions recorded: Retifanlimab; Zanzalintinib. Conditions listed: Colon Cancer Metastatic. Primary outcome: Intent for Curative Surgery Post-Treatment. Colorectal eligibility wording from the registry: \"* Histological-confirmed adenocarcinoma of the colon that is amenable to curative intent resection\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07677579","url":"https://clinicaltrials.gov/study/NCT07677579"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["retifanlimab","zanzalintinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07677579","phase":"2","setting":"NIMBLE-CRC: NeoImmunoModulation Before Leveraging Excision in Colorectal Rectal Cancer","sponsor":"Northwell Health","started":"2026-08-30","startedType":"estimated","enrolled":26,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07386704","kind":"trial","name":"Nimotuzumab Combined With Chemoradiotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of nimotuzumab in pancreatic cancer, run by Peking University First Hospital, now recruiting.","summary":"Nimotuzumab Combined With Chemoradiotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT07386704 by Peking University First Hospital, with a registry enrolment figure of 30 participants, started 2025-12-09 and due to reach its primary completion in 2026-12-09. Interventions recorded: Nimotuzumab combined with chemoradiotherapy. Conditions listed: Pancreatic Cancer Non-resectable. Primary outcome: LCR. Pancreatic eligibility wording from the registry: \"Confirmed by histological or cytological examination as pancreatic adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07386704","url":"https://clinicaltrials.gov/study/NCT07386704"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["nimotuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07386704","phase":"2","setting":"A Prospective, Single-arm Study of Nimotuzumab Combined With Radiotherapy and Chemotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer","sponsor":"Peking University First Hospital","started":"2025-12-09","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06409429","kind":"trial","name":"Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer","aka":[],"tldr":"A phase 2/3 trial of nimotuzumab in pancreatic cancer, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer is a phase 2/3, randomised interventional study registered as NCT06409429 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 146 participants, started 2024-05-01 and due to reach its primary completion in 2027-05-30. Interventions recorded: Nimotuzumab; GX; Placebo. Conditions listed: Pancreatic Cancer. Primary outcome: relapse-free survival (RFS). Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed resected pancreatic ductal adenocarcinoma (PDAC), resectable evaluation is based on criteria of NCCN guidelines, no evidence of distant metastasis as demonstrated by imaging;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06409429","url":"https://clinicaltrials.gov/study/NCT06409429"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["nimotuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06409429","phase":"2/3","setting":"A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2024-05-01","startedType":"estimated","enrolled":146,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06389760","kind":"trial","name":"Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of nimotuzumab and fOLFIRINOX / mFOLFIRINOX in pancreatic cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, now recruiting.","summary":"Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer is a phase 2, interventional study registered as NCT06389760 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, with a registry enrolment figure of 57 participants, started 2023-10-18 and due to reach its primary completion in 2026-09-30. Interventions recorded: Nimotuzumab; mFOLFIRINOX; GX. Conditions listed: Pancreatic Cancer. Primary outcome: disease-free survival (DFS). Pancreatic eligibility wording from the registry: \"Had undergone complete macroscopic resection for pancreatic cancer (R0 or R1 resection) with histological confirmation and with no evidence of distant metastasis as demonstrated by imaging;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06389760","url":"https://clinicaltrials.gov/study/NCT06389760"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["nimotuzumab","folfirinox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06389760","phase":"2","setting":"Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Open-label Study","sponsor":"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","started":"2023-10-18","startedType":"actual","enrolled":57,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07277452","kind":"trial","name":"Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer","aka":["NOTABLE-309"],"tldr":"A phase 2 trial of nimotuzumab and gemcitabine + nab-paclitaxel in pancreatic cancer, run by The First Affiliated Hospital with Nanjing Medical University, not yet recruiting.","summary":"Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer is a phase 2, randomised interventional study registered as NCT07277452 by The First Affiliated Hospital with Nanjing Medical University, with a registry enrolment figure of 156 participants, started 2025-12-10 and due to reach its primary completion in 2028-12-10. Interventions recorded: Nimotuzumab; AG regimen; Placebo. Conditions listed: Pancreatic Cancer, Adult. Primary outcome: disease-free survival (DFS). Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07277452","url":"https://clinicaltrials.gov/study/NCT07277452"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["nimotuzumab","gemcitabine-nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07277452","phase":"2","setting":"Randomized Double-blind, Placebo-controlled, Multicenter Clinical Study of Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer","sponsor":"The First Affiliated Hospital with Nanjing Medical University","started":"2025-12-10","startedType":"estimated","enrolled":156,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06343116","kind":"trial","name":"Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer","aka":["NOTABLE-308"],"tldr":"A phase 3 trial of trifluridine/tipiracil in colorectal cancer, run by Biotech Pharmaceutical Co., Ltd., not yet recruiting.","summary":"Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT06343116 by Biotech Pharmaceutical Co., Ltd., with a registry enrolment figure of 420 participants, started 2024-04 and due to reach its primary completion in 2027-04. Interventions recorded: Nimotuzumab injection; Placebo; Trifluridine/tipiracil. Conditions listed: Refractory Metastatic Colorectal Cancer. Primary outcome: overall survival (OS); dose-limiting toxicity (DLT). Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed diagnosis of colorectal cancer (CRC);\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06343116","url":"https://clinicaltrials.gov/study/NCT06343116"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["trifluridine-tipiracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06343116","phase":"3","setting":"Randomized Double-blind, Placebo-controlled, Multicenter Clinical Study of Nimotuzumab Combined With Trifluridine/Tipiracil in Third-line and Beyond for the Treatment of Metastatic Colorectal Cancer","sponsor":"Biotech Pharmaceutical Co., Ltd.","started":"2024-04","startedType":"estimated","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05984810","kind":"trial","name":"NIR-Fluorescence Guided Surgical Resection of Neoadjuvant Treated Localized Pancreatic Cancer Using SGM-101","aka":["FLUOPANC-II"],"tldr":"A phase 2 trial in pancreatic cancer, run by Leiden University Medical Center, now recruiting.","summary":"NIR-Fluorescence Guided Surgical Resection of Neoadjuvant Treated Localized Pancreatic Cancer Using SGM-101 is a phase 2, interventional study registered as NCT05984810 by Leiden University Medical Center, with a registry enrolment figure of 20 participants, started 2024-03-18 and due to reach its primary completion in 2026-12. Interventions recorded: Fluorescence-guided surgery using CEA-targeted fluorophore SGM-101. Conditions listed: Pancreas Adenocarcinoma. Primary outcome: Intra-operative visualization of neoadjuvant treated pancreatic tumors using Near-infrared fluorescence imaging,. Pancreatic eligibility wording from the registry: \"Neoadjuvant treated (borderline) resectable or locally advanced pancreatic cancer scheduled for a surgical resection\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05984810","url":"https://clinicaltrials.gov/study/NCT05984810"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac","locally-advanced-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05984810","phase":"2","setting":"A Performance Study of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for Fluorescence-guided Imaging to Determine Local Extent and Resectability During Surgical Resection of Pancreatic Ductal Adenocarcinoma After Neoadjuvant Treatment","sponsor":"Leiden University Medical Center","started":"2024-03-18","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05718323","kind":"trial","name":"Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC","aka":["RAISE"],"tldr":"A phase 2 trial of niraparib in lung cancer, run by ETOP IBCSG Partners Foundation, now recruiting.","summary":"Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC is a phase 2, interventional study registered as NCT05718323 by ETOP IBCSG Partners Foundation, with a registry enrolment figure of 44 participants, started 2023-12-20 and due to reach its primary completion in 2026-12. Interventions recorded: Niraparib. Conditions listed: SCLC,Extensive Stage; SLFN11-positive. Primary outcome: Progression-free survival (PFS) rate at 3 months by investigator assessment (according to RECIST v1.1). Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed ED-SCLC (stage IV according to the 8th TNM classification)\". Sites: France, Germany, Italy, Spain, Switzerland. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05718323","url":"https://clinicaltrials.gov/study/NCT05718323"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["niraparib"],"companies":["etop-ibcsg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05718323","phase":"2","setting":"A Single-arm Phase II Trial of the Addition of Niraparib to Anti-PD-L1 Antibody Maintenance in Patients With SLFN11-positive, Extensive-disease Small Cell Lung Cancer.","sponsor":"ETOP IBCSG Partners Foundation","started":"2023-12-20","startedType":"actual","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03348904","kind":"trial","name":"Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of Nivolumab, Epacadostat, Carboplatin, Cisplatin, Gemcitabine, Paclitaxel / nab-paclitaxel and Pemetrexed in Lung cancer, run by Incyte Corporation, recorded as terminated on the registry.","summary":"Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT03348904 by Incyte Corporation, with 2 participants recorded, started 2017-12-27 and due to reach its primary completion in 2018-05-22. Interventions recorded: Nivolumab, Epacadostat, Placebo, Carboplatin, Cisplatin, Gemcitabine, Paclitaxel, Pemetrexed. Conditions recorded: Lung Cancer.\n\nLinked to the drug Epacadostat because the registry names it among its interventions and Lung cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03348904","url":"https://clinicaltrials.gov/study/NCT03348904"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["nivolumab","epacadostat","carboplatin","cisplatin","gemcitabine","paclitaxel","pemetrexed"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03348904","phase":"3","setting":"A Phase 3, Randomized, Global Trial of Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in First-line Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Incyte Corporation","started":"2017-12-27","startedType":"actual","enrolled":2,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05310643","kind":"trial","name":"Nivolumab and Ipilimumab in Anti-PD1-Resistant dMMR/MSI mCRC","aka":["NIPIRESCUE"],"tldr":"A phase 2 trial of nivolumab and ipilimumab in colorectal cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group, now recruiting.","summary":"Nivolumab and Ipilimumab in Anti-PD1-Resistant dMMR/MSI mCRC is a phase 2, interventional study registered as NCT05310643 by GERCOR - Multidisciplinary Oncology Cooperative Group, with a registry enrolment figure of 30 participants, started 2022-05-05 and due to reach its primary completion in 2025-09. Interventions recorded: Nivolumab; Ipilimumab. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Objective response rate (ORR) by RECIST 1.1. Colorectal eligibility wording from the registry: \"Histologically confirmed colorectal adenocarcinoma,\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05310643","url":"https://clinicaltrials.gov/study/NCT05310643"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":["gercor"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05310643","phase":"2","setting":"Nivolumab and Ipilimumab in Patients With dMMR and/or MSI Metastatic Colorectal Cancer Resistant to Anti-PD1 Monotherapy: An Open-label Phase II GERCOR Trial (NIPIRESCUE)","sponsor":"GERCOR - Multidisciplinary Oncology Cooperative Group","started":"2022-05-05","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03391869","kind":"trial","name":"Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer","aka":["LONESTAR"],"tldr":"A phase 3 trial of ipilimumab and nivolumab in lung cancer, run by M.D. Anderson Cancer Center, active but no longer recruiting.","summary":"Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT03391869 by M.D. Anderson Cancer Center, with a registry enrolment figure of 339 participants, started 2017-12-29 and due to reach its primary completion in 2027-03-31. Interventions recorded: Ipilimumab; Local Consolidation Therapy; Nivolumab; Quality-of-Life Assessment; Radiation Therapy; Therapeutic Conventional Surgery. Conditions listed: Lung Adenocarcinoma; Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8. Primary outcome: Overall survival (OS) in overall population; OS in oligometastatic subgroup. Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed non-small cell lung cancer; if a diagnostic biopsy is available, a pre-treatment biopsy is not required\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03391869","url":"https://clinicaltrials.gov/study/NCT03391869"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-adenocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["ipilimumab","nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03391869","phase":"3","setting":"Randomized Phase III Trial of Local Consolidation Therapy (LCT) After Nivolumab and Ipilimumab for Immunotherapy-Naive Patients With Metastatic Non-Small Cell Lung Cancer (LONESTAR)","sponsor":"M.D. Anderson Cancer Center","started":"2017-12-29","startedType":"actual","enrolled":339,"enrolledBasis":"registry","outcomes":[]},{"id":"nivopostop","kind":"trial","name":"NIVOPOSTOP (GORTEC 2018-01)","aka":[],"tldr":"NIVOPOSTOP showed that adding the immunotherapy nivolumab to chemoradiation after surgery for high-risk head and neck cancer kept about one in ten more patients free of relapse at three years, the first improvement in post-operative treatment in two decades.","summary":"NIVOPOSTOP randomised 680 patients whose head and neck squamous cell carcinoma had been removed but showed high-risk features, extranodal extension or positive margins, to standard postoperative cisplatin chemoradiation with or without nivolumab given before, during and after it. Postoperative chemoradiation had been the standard since the Bernier and Cooper trials of 2004, and no drug had improved on it since.\n\nPresented at the ASCO plenary session in June 2025 by Jean Bourhis for the French GORTEC group, the trial met its primary endpoint: three-year disease-free survival was 63.1 percent with nivolumab against 52.5 percent without (hazard ratio 0.76). Most patients were HPV-negative smokers with oral cavity, laryngeal or hypopharyngeal tumours, the group with the most to gain. Toxicity was as expected for a PD-1 antibody added to chemoradiation.\n\nTogether with KEYNOTE-689, which placed pembrolizumab before and after surgery, it brought immunotherapy into curative-intent treatment of head and neck cancer after several concurrent chemoradiation trials had failed, and it suggests that timing, around rather than during radiotherapy, is what matters.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03576417","url":"https://clinicaltrials.gov/study/NCT03576417"}],"tags":[],"related":[],"cancers":["head-and-neck","hpv-negative-head-and-neck-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":["pd1"],"drugs":["nivolumab","cisplatin"],"companies":["gortec"],"institutions":[],"pathways":[],"terms":["chemoradiation","neoadjuvant-adjuvant","efs"],"trials":["keynote-689"],"people":["jean-bourhis"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03576417","phase":"3","setting":"Resected locally advanced head and neck squamous cell carcinoma at high risk of relapse (extranodal extension or positive margins): nivolumab before and during postoperative cisplatin chemoradiation, then nivolumab alone, versus chemoradiation alone","sponsor":"GORTEC","result":"Three-year disease-free survival 63.1% vs 52.5% (hazard ratio 0.76).","started":"2018-10-10","startedType":"actual","yearReported":2025,"enrolled":680,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Nivolumab + postoperative chemoradiation","value":63.1},{"name":"Postoperative chemoradiation","value":52.5}],"hr":0.76}],"replication":"KEYNOTE-689 (perioperative pembrolizumab) is the concordant trial; the concurrent chemoradiation trials JAVELIN Head and Neck 100 and KEYNOTE-412 were negative, so the benefit appears to depend on when the antibody is given."},{"id":"nlst-nelson","kind":"trial","name":"NLST & NELSON (low-dose CT screening)","aka":[],"tldr":"The two trials that proved a yearly low-dose CT scan cuts lung cancer deaths in heavy smokers.","summary":"NLST (NEJM 2011) showed a 20% relative reduction in lung cancer mortality with three annual low-dose CTs versus chest radiography. NELSON (NEJM 2020) showed a 24% reduction in men at 10 years with volume-based nodule management and a lower false-positive rate. Together they underpin USPSTF (age 50-80, ≥20 pack-years) and European screening recommendations. Uptake remains low.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT00047385","url":"https://clinicaltrials.gov/study/NCT00047385"},{"label":"NELSON, NEJM 2020","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1911793"}],"tags":[],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["low-dose-ct-screening","ct"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["harry-de-koning","denise-aberle"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Annual low-dose CT versus chest X-ray (NLST, 53,454 heavy smokers) or no screening (NELSON, 15,789) in current and former smokers","sponsor":"NCI; Dutch-Belgian consortium","result":"Lung cancer mortality reduced 20% (NLST) and 24% in men (NELSON).","yearReported":2011,"enrolled":53454,"enrolledBasis":"registry","outcomes":[{"endpoint":"NLST: relative reduction in lung cancer mortality","primary":true,"unit":"%","arms":[{"name":"Low-dose CT vs chest X-ray","value":20}],"ci":[6.8,26.7],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1102873"},{"endpoint":"NELSON: relative reduction in lung cancer mortality at 10 years (men)","primary":true,"unit":"%","arms":[{"name":"Low-dose CT vs no screening","value":24}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1911793"}],"replication":"Two independent randomised trials on two continents agree; MILD and LUSI are consistent."},{"id":"nmtrc003","kind":"trial","name":"NMTRC003/003B (DFMO maintenance)","aka":[],"tldr":"NMTRC003 was the single-arm study, compared against historical patients, that got eflornithine approved as maintenance; the design remains debated.","summary":"NMTRC003 and 003B, trial NCT02395666 sponsored by the Beat Childhood Cancer Consortium and published in JCO in 2024, was the single-arm study, compared against historical patients, that got oral eflornithine approved as two years of maintenance for high-risk neuroblastoma in remission after standard therapy including anti-GD2 immunotherapy, and the design remains debated. In 105 enrolled patients, event-free and overall survival were better than in a propensity-matched external control drawn from ANBL0032, and the FDA approved the drug in December 2023 while acknowledging the externally controlled design in a rare paediatric setting. A randomised trial has not been done, and uptake is being tracked in ANBL1531, so whether the benefit is real remains the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02395666","url":"https://clinicaltrials.gov/study/NCT02395666"}],"tags":["lesson:external-control"],"related":[],"cancers":["neuroblastoma","neuroblastoma-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["eflornithine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02395666","phase":"2","setting":"High-risk neuroblastoma in remission after standard therapy including anti-GD2: 2 years of oral eflornithine (single arm, externally controlled)","sponsor":"Beat Childhood Cancer Consortium","result":"EFS HR 0.48 vs external control.","started":"2015-03-05","startedType":"actual","yearReported":2023,"enrolled":105,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival","primary":true,"arms":[{"name":"Eflornithine","n":90},{"name":"External control (ANBL0032)","n":270}],"hr":0.48,"ci":[0.27,0.85],"source":"https://ascopubs.org/doi/10.1200/JCO.24.00546"}],"replication":"Not replicated in a randomised trial; uptake tracked in ANBL1531."},{"id":"noa-08","kind":"trial","name":"NOA-08","aka":["Methusalem","NOA-8"],"tldr":"NOA-08 showed that older people with glioblastoma can be treated with temozolomide tablets instead of six weeks of radiotherapy without living less long, and that the MGMT test tells you which to choose: chemotherapy if the gene is methylated, radiotherapy if it is not.","summary":"NOA-08 (Methusalem) was a randomised phase 3 non-inferiority trial of the German Neuro-oncology Working Group in 412 patients over 65 with anaplastic astrocytoma or glioblastoma. Patients received dose-dense temozolomide 100 mg/m2 one week on, one week off, or radiotherapy of 60 Gy; 373 were treated and analysed. The primary endpoint was overall survival.\n\nMedian overall survival was 8.6 months with temozolomide and 9.6 months with radiotherapy (hazard ratio 1.09), meeting the non-inferiority margin, and event-free survival did not differ. MGMT promoter methylation predicted longer survival overall and, critically, predicted which treatment worked: event-free survival was 8.4 months with temozolomide against 4.6 with radiotherapy in methylated tumours, and 3.3 against 4.6 months in unmethylated tumours. With the Nordic trial, NOA-08 is why the corpus's glioblastoma page chooses between temozolomide alone and radiotherapy alone by MGMT status in older patients.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01502241","url":"https://clinicaltrials.gov/study/NCT01502241"}],"tags":["soc-trials"],"related":[],"cancers":["glioblastoma","idh-mutant-astrocytoma","brain-tumours"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["temozolomide"],"companies":[],"institutions":["heidelberg-nct"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-noa-08-temozolomide-vs-radiotherapy-elderly-wick-lancet-oncol-2012"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01502241","phase":"3","setting":"Patients over 65 with newly diagnosed anaplastic astrocytoma or glioblastoma and a Karnofsky score of 60 or more: dose-dense temozolomide (one week on, one week off) alone against radiotherapy alone (60 Gy), with overall survival non-inferiority as the primary endpoint and MGMT promoter methylation analysed","sponsor":"Heidelberg University","result":"Median overall survival 8.6 months with temozolomide against 9.6 months with radiotherapy (hazard ratio 1.09, non-inferior); MGMT-methylated tumours did better with temozolomide and unmethylated tumours with radiotherapy.","started":"2005-01","yearReported":2012,"enrolled":412,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (non-inferiority)","primary":true,"unit":"months","arms":[{"name":"Dose-dense temozolomide alone","n":195,"value":8.6,"note":"95% CI 7.3 to 10.2"},{"name":"Radiotherapy alone (60 Gy)","n":178,"value":9.6,"note":"95% CI 8.2 to 10.8"}],"hr":1.09,"ci":[0.84,1.42],"p":"0.033 (non-inferiority)","source":"https://doi.org/10.1016/S1470-2045(12)70164-X"},{"endpoint":"Event-free survival","unit":"months","arms":[{"name":"Dose-dense temozolomide alone","n":195,"value":3.3},{"name":"Radiotherapy alone (60 Gy)","n":178,"value":4.7}],"hr":1.15,"ci":[0.92,1.43],"p":"0.043 (non-inferiority)","source":"https://doi.org/10.1016/S1470-2045(12)70164-X"},{"endpoint":"Event-free survival, MGMT promoter methylated","unit":"months","arms":[{"name":"Dose-dense temozolomide alone","value":8.4,"note":"95% CI 5.5 to 11.7"},{"name":"Radiotherapy alone (60 Gy)","value":4.6,"note":"95% CI 4.2 to 5.0"}],"source":"https://doi.org/10.1016/S1470-2045(12)70164-X"},{"endpoint":"Event-free survival, MGMT promoter unmethylated","unit":"months","arms":[{"name":"Dose-dense temozolomide alone","value":3.3,"note":"95% CI 3.0 to 3.5"},{"name":"Radiotherapy alone (60 Gy)","value":4.6,"note":"95% CI 3.7 to 6.3"}],"source":"https://doi.org/10.1016/S1470-2045(12)70164-X"},{"endpoint":"Overall survival by MGMT status (both arms)","unit":"months","arms":[{"name":"MGMT promoter methylated","value":11.9},{"name":"MGMT promoter unmethylated","value":8.2}],"hr":0.62,"ci":[0.42,0.91],"p":"0.014","source":"https://doi.org/10.1016/S1470-2045(12)70164-X"}]},{"id":"nct06356714","kind":"trial","name":"Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens for the Treatment of Potentially Hazardous Colorectal Cancer SD Statu","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Sun Jing, now recruiting.","summary":"Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens for the Treatment of Potentially Hazardous Colorectal Cancer SD Status is a phase 2, interventional study registered as NCT06356714 by Sun Jing, with a registry enrolment figure of 22 participants, started 2025-03-15 and due to reach its primary completion in 2026-09-24. Interventions recorded: Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens. Conditions listed: Colorectal Cancer; Colorectal Neoplasms. Primary outcome: Progression-free survival(PFS). Colorectal eligibility wording from the registry: \"Colorectal adenocarcinoma confirmed by pathologic histology and/or cytology and imaging;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06356714","url":"https://clinicaltrials.gov/study/NCT06356714"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06356714","phase":"2","setting":"An Open Intervention Study of Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens for the Treatment of Potentially Hazardous Colorectal Cancer SD(Stable Disease) Status","sponsor":"Sun Jing","started":"2025-03-15","startedType":"actual","enrolled":22,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07674732","kind":"trial","name":"Nodal-Region Sparing Short-Course RT With Chemo-PD-1/Bevacizumab vs. Short-Course RT With Chemotherapy as TNT in pMMR/MSS Locally Advanced Rectal Cancer","aka":["SPARK II"],"tldr":"A phase 2 trial of bevacizumab (glioblastoma use) in colorectal cancer, run by Dechang Diao, now recruiting.","summary":"Nodal-Region Sparing Short-Course RT With Chemo-PD-1/Bevacizumab vs. Short-Course RT With Chemotherapy as TNT in pMMR/MSS Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT07674732 by Dechang Diao, with a registry enrolment figure of 76 participants, started 2026-06-24 and due to reach its primary completion in 2029-06-24. Interventions recorded: Short-course Radiotherapy plus Chemotherapy; Nodal-Region Sparing Short-Course Radiotherapy Followed by Sequential Chemotherapy With PD-1 Monoclonal Antibody and Bevacizumab. Conditions listed: Short-course Radiotherapy Plus Chemotherapy; Nodal-Region Sparing Short-Course Radiotherapy Followed by Sequential Chemotherapy With PD-1 Monoclonal Antibody and Bevacizumab. Primary outcome: Complete Response (CR) Rate; Adverse events. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07674732","url":"https://clinicaltrials.gov/study/NCT07674732"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07674732","phase":"2","setting":"Nodal-Region Sparing Short-Course Radiotherapy Followed by Sequential Chemotherapy With PD-1 Monoclonal Antibody and Bevacizumab Versus Short-course Radiotherapy Plus Chemotherapy as Total Neoadjuvant Therapy in pMMR/MSS Locally Advanced Rectal Cancer","sponsor":"Dechang Diao","started":"2026-06-24","startedType":"actual","enrolled":76,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07230639","kind":"trial","name":"Node-Sparing Hypofractionated Radiotherapy Plus Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advanced Colon Cancer: A Prospective, Randomized,","aka":["MODIFI-CC"],"tldr":"A phase 2 trial in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"Node-Sparing Hypofractionated Radiotherapy Plus Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advanced Colon Cancer: A Prospective, Randomized, Phase II Trial is a phase 2, randomised interventional study registered as NCT07230639 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 52 participants, started 2025-08-30 and due to reach its primary completion in 2030-08-29. Interventions recorded: Node-Sparing Radiotherapy(25Gy/5F) plus Chemotherapy and PD-1 inhibitor; Node-Sparing Radiotherapy(24Gy/4F) plus Chemotherapy and PD-1 inhibitor. Conditions listed: Neoadjuvant Therapies; Immune Checkpoint Therapy; Radiotherapy. Primary outcome: Pathological Complete Response(pCR) Rate. Colorectal eligibility wording from the registry: \"Histologically confirmed colon adenocarcinoma (without squamous or sarcomatoid components)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07230639","url":"https://clinicaltrials.gov/study/NCT07230639"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07230639","phase":"2","setting":"Node-Sparing Hypofractionated Radiotherapy Plus Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advanced Colon Cancer: A Prospective, Randomized, Phase II Trial","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2025-08-30","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07279077","kind":"trial","name":"Node-Sparing Low-Dose Radiotherapy Concurrent With Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advanced Colon Cancer: A Prospective, Single-Ar","aka":["MODIFI-L"],"tldr":"A phase 2 trial in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"Node-Sparing Low-Dose Radiotherapy Concurrent With Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advanced Colon Cancer: A Prospective, Single-Arm, Phase II Trial is a phase 2, interventional study registered as NCT07279077 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 38 participants, started 2025-11-26 and due to reach its primary completion in 2030-11-25. Interventions recorded: Node-Sparing Low-Dose Radiotherapy Concurrent With Chemotherapy and PD-1 Inhibitor. Conditions listed: Colon Cancer; Neoadjuvant Therapies; Immune Checkpoint Therapy; Radiation Therapy. Primary outcome: Pathological Complete Response(pCR) Rate. Colorectal eligibility wording from the registry: \"Histologically confirmed adenocarcinoma of the colon (without squamous or sarcomatoid components)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07279077","url":"https://clinicaltrials.gov/study/NCT07279077"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07279077","phase":"2","setting":"Node-Sparing Low-Dose Radiotherapy Concurrent With Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advanced Colon Cancer: A Prospective, Single-Arm, Phase II Trial","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2025-11-26","startedType":"actual","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06204094","kind":"trial","name":"Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer","aka":["CASINOs"],"tldr":"A phase 2 trial of sintilimab, capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Jinhua Central Hospital, now recruiting.","summary":"Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer is a phase 2, interventional study registered as NCT06204094 by Jinhua Central Hospital, with a registry enrolment figure of 37 participants, started 2024-02-05 and due to reach its primary completion in 2027-09-01. Interventions recorded: node-sparing short-course radiotherapy; Sintilimab; Capecitabine; Oxaliplatin; TME surgery; watch and wait. Conditions listed: Locally Advanced Rectal Cancer. Primary outcome: Complete response. Colorectal eligibility wording from the registry: \"* Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT2N+M0/cT3-4N0/+M0, the lymph nodes are limited to the mesorectum\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06204094","url":"https://clinicaltrials.gov/study/NCT06204094"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["sintilimab","capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06204094","phase":"2","setting":"Total Neoadjuvant CAPOX And PD-1 Inhibitor（Sintilimab） Combined With Node-sparing Short-course Radiotherapy For MSS Locally Advanced Of Middle And Low Rectal Cancer(CASINOs): An Open Label, Single-arm, Prospective Clinical Trial","sponsor":"Jinhua Central Hospital","started":"2024-02-05","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07068763","kind":"trial","name":"Node-Sparing Short-Course Radiation Combined With Capecitabine and PD-1/CTLA-4 for MSS Early Rectal Cancer","aka":["mRCAT-E"],"tldr":"A phase 2 trial of capecitabine in colorectal cancer, run by Sir Run Run Shaw Hospital, now recruiting.","summary":"Node-Sparing Short-Course Radiation Combined With Capecitabine and PD-1/CTLA-4 for MSS Early Rectal Cancer is a phase 2, interventional study registered as NCT07068763 by Sir Run Run Shaw Hospital, with a registry enrolment figure of 52 participants, started 2025-10-09 and due to reach its primary completion in 2026-12-31. Interventions recorded: Lymph-node-sparing short-course radiotherapy; Capecitabine; PD-1/CTLA-4 inhibitor (Aiparolitoworixureli injection). Conditions listed: Rectal Cancer. Primary outcome: Clinical and pathological complete response rate (CR rate). Colorectal eligibility wording from the registry: \"Patients diagnosed with low rectal cancer within 7 cm from the lower edge of the tumor to the anal verge by pelvic MRI and rectal ultrasound, the clinical stage is cT2-3N0M0\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07068763","url":"https://clinicaltrials.gov/study/NCT07068763"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07068763","phase":"2","setting":"Node-Sparing Short-Course Radiation Combined With Capecitabine and PD-1/CTLA-4 for MSS Early Middle and Low Rectal Cancer (mRCAT-E): An Open-label, Single-arm, Prospective Multicenter Clinical Trial","sponsor":"Sir Run Run Shaw Hospital","started":"2025-10-09","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06507371","kind":"trial","name":"Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer","aka":["mRCAT-III"],"tldr":"A phase 3 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Sir Run Run Shaw Hospital, active but no longer recruiting.","summary":"Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer is a phase 3, randomised interventional study registered as NCT06507371 by Sir Run Run Shaw Hospital, with a registry enrolment figure of 170 participants, started 2024-07-29 and due to reach its primary completion in 2026-05-04. Interventions recorded: node-sparing modified short-course radiotherapy; PD-1 antibody; Capecitabine; Oxaliplatin; standard short-course radiotherapy. Conditions listed: Rectal Cancer. Primary outcome: pathological complete response (pCR) rate. Colorectal eligibility wording from the registry: \"Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT3-4bN0/+M0, and the lymph nodes are limited to the mesorectum\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06507371","url":"https://clinicaltrials.gov/study/NCT06507371"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06507371","phase":"3","setting":"Node-sparing Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer : An Randomized, Prospective, Multicenter, Open-label, Phase III Clinical Trial (mRCAT-III)","sponsor":"Sir Run Run Shaw Hospital","started":"2024-07-29","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06594692","kind":"trial","name":"Node-Sparing Short-Course Radiation With CAPOX and Sintilimab for MSS Locally Advanced Colon Cancer: A Randomized, Prospective, Multicenter Study","aka":["mRCAT-C"],"tldr":"A phase 2 trial in colorectal cancer, run by Sir Run Run Shaw Hospital, not yet recruiting.","summary":"Node-Sparing Short-Course Radiation With CAPOX and Sintilimab for MSS Locally Advanced Colon Cancer: A Randomized, Prospective, Multicenter Study is a phase 2, randomised interventional study registered as NCT06594692 by Sir Run Run Shaw Hospital, with a registry enrolment figure of 140 participants, started 2024-10 and due to reach its primary completion in 2025-09-30. Interventions recorded: Node-Sparing Short-Course Radiotherapy Combined with CAPOX and Sintilimab; CAPOX Chemotherapy. Conditions listed: Microsatellite Stable (MSS) Colon Cancer; Locally Advanced Colon Cancer. Primary outcome: pathological complete response rate. Colorectal eligibility wording from the registry: \"Tumor confirmed by colonoscopy and enhanced abdominal CT to be ≥ 12 cm from the anal verge\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06594692","url":"https://clinicaltrials.gov/study/NCT06594692"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06594692","phase":"2","setting":"Node-sparing Modified Short-Course Radiation Combined With CAPOX and Sintilimab for MSS Locally Advanced Colon Cancer : A Randomized, Prospective, Multicenter, Open-label Clinical Trial","sponsor":"Sir Run Run Shaw Hospital","started":"2024-10","startedType":"estimated","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06958419","kind":"trial","name":"Node-Sparing Short-Course Radiotherapy Plus Chemotherapy, Bevacizumab and PD-1 Inhibitor in Metastatic pMMR/MSS Colorectal Cancer (MODIFI-CRC)","aka":["MODIFI-CRC"],"tldr":"A phase 2/3 trial in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"Node-Sparing Short-Course Radiotherapy Plus Chemotherapy, Bevacizumab and PD-1 Inhibitor in Metastatic pMMR/MSS Colorectal Cancer (MODIFI-CRC) is a phase 2/3, randomised interventional study registered as NCT06958419 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 286 participants, started 2025-05-01 and due to reach its primary completion in 2030-12-31. Interventions recorded: Node-Sparing Radiotherapy plus first-line therapy; First-line treatment. Conditions listed: Immune Checkpoint Therapy; Radiotherapy; Metastatic Colorectal Cancer (CRC). Primary outcome: Objective Response Rate(ORR); Progression-free survival (PFS). Colorectal eligibility wording from the registry: \"* Histologically or cytologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06958419","url":"https://clinicaltrials.gov/study/NCT06958419"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06958419","phase":"2/3","setting":"Node-Sparing Short-Course Radiotherapy Followed by First-Line Chemotherapy Plus Bevacizumab and PD-1 Inhibitor Versus Chemotherapy Plus Bevacizumab Alone in Metastatic pMMR/MSS Colorectal Cancer: A Randomized, Phase II/III Trial (MODIFI-CRC)","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2025-05-01","startedType":"actual","enrolled":286,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06958432","kind":"trial","name":"Node-Sparing Short-Course Radiotherapy Sequential Chemotherapy and PD-1 Inhibitor for Mid/Low pMMR/MSS Rectal Cancer (MODIFI-RC-II)","aka":["MODIFI-RC-II"],"tldr":"A phase 2/3 trial in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"Node-Sparing Short-Course Radiotherapy Sequential Chemotherapy and PD-1 Inhibitor for Mid/Low pMMR/MSS Rectal Cancer (MODIFI-RC-II) is a phase 2/3, randomised interventional study registered as NCT06958432 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 430 participants, started 2025-05-01 and due to reach its primary completion in 2030-12-31. Interventions recorded: Node-Sparing Radiotherapy plus Chemotherapy and PD-1 inhibitor; Conventional Radiotherapy plus Chemotherapy and PD-1 inhibitor. Conditions listed: Rectal Cancer; Neoadjuvant Therapies; Immune Checkpoint Therapy; Radiotherapy. Primary outcome: Complete response (CR) rate; Event-Free Survival (EFS). Colorectal eligibility wording from the registry: \"* Histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06958432","url":"https://clinicaltrials.gov/study/NCT06958432"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06958432","phase":"2/3","setting":"Node-Sparing Short-Course Radiotherapy Plus Sequential Chemotherapy and PD-1 Inhibitor for Mid/Low pMMR/MSS Rectal Cancer: An Open-Label, Randomized, Prospective Phase II/III Trial (MODIFI-RC-II)","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2025-05-01","startedType":"actual","enrolled":430,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05972655","kind":"trial","name":"Nodes-sparing Short-course Radiation Combined With CAPOX and Tislelizumab for MSS Middle and Low Rectal Cancer","aka":["mRCAT"],"tldr":"A phase 2 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Sir Run Run Shaw Hospital, now recruiting.","summary":"Nodes-sparing Short-course Radiation Combined With CAPOX and Tislelizumab for MSS Middle and Low Rectal Cancer is a phase 2, interventional study registered as NCT05972655 by Sir Run Run Shaw Hospital, with a registry enrolment figure of 32 participants, started 2023-08-02 and due to reach its primary completion in 2024-08-20. Interventions recorded: Modified short-course radiotherapy; PD-1 antibody; Capecitabine; Oxaliplatin. Conditions listed: Low Rectal Cancer. Primary outcome: Pathological complete response (pCR) rate. Colorectal eligibility wording from the registry: \"Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT2N+M0/cT3-4aN0/+M0, the lymph nodes are limited to the mesorectum, the circumferential resection margin is negative\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05972655","url":"https://clinicaltrials.gov/study/NCT05972655"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05972655","phase":"2","setting":"Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer (mRCAT): An Open-label, Single-arm, Prospective Multicenter Clinical Trial","sponsor":"Sir Run Run Shaw Hospital","started":"2023-08-02","startedType":"actual","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03875781","kind":"trial","name":"Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer","aka":["NORAD01"],"tldr":"A phase 3 trial in colorectal cancer, run by Assistance Publique - Hôpitaux de Paris, now recruiting.","summary":"Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer is a phase 3, randomised interventional study registered as NCT03875781 by Assistance Publique - Hôpitaux de Paris, with a registry enrolment figure of 540 participants, started 2019-06-05 and due to reach its primary completion in 2026-12-05. Interventions recorded: Chemotherapy; Radiochemotherapy. Conditions listed: Rectal Cancer; Advanced Cancer. Primary outcome: Survival. Colorectal eligibility wording from the registry: \"* Histologically proven middle or low rectal carcinoma, ≤ 10 cm from the anal verge on MRI (sagittal slide)\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03875781","url":"https://clinicaltrials.gov/study/NCT03875781"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03875781","phase":"3","setting":"Non Inferiority Multicenter Phase III Randomized Trial Comparing Preoperative Chemotherapy Only to Chemotherapy Followed by Chemoradiotherapy for Locally Advanced Resectable Rectal Cancer (Intergroup FRENCH-GRECCAR- PRODIGE)","sponsor":"Assistance Publique - Hôpitaux de Paris","started":"2019-06-05","startedType":"actual","enrolled":540,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06795503","kind":"trial","name":"Non-Inferiority Study on MRNA-lncRNA Model in Low-Risk Triple-Negative Breast Cancer Patients","aka":[],"tldr":"A phase 3 trial of docetaxel, cyclophosphamide, epirubicin and paclitaxel / nab-paclitaxel in triple-negative breast cancer, run by Fudan University, not yet recruiting.","summary":"Non-Inferiority Study on MRNA-lncRNA Model in Low-Risk Triple-Negative Breast Cancer Patients is a phase 3, randomised interventional study registered as NCT06795503 by Fudan University, with a registry enrolment figure of 1462 participants, started 2025-02 and due to reach its primary completion in 2028-08. Interventions recorded: Docetaxel plus cyclophosphamide; Epirubicin, cyclophosphamide plus paclitaxel. Conditions listed: Triple-negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Histologically confirmed invasive triple-negative breast cancer (TNBC), defined as breast cancer with estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) all determined to be negative by pathological testing\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06795503","url":"https://clinicaltrials.gov/study/NCT06795503"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel","cyclophosphamide","epirubicin","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06795503","phase":"3","setting":"Non-Inferiority Study on MRNA-lncRNA Model in Low-Risk Triple-Negative Breast Cancer Patients","sponsor":"Fudan University","started":"2025-02","startedType":"estimated","enrolled":1462,"enrolledBasis":"registry","outcomes":[]},{"id":"nordicc","kind":"trial","name":"NordICC (Nordic-European Initiative on Colorectal Cancer)","aka":[],"tldr":"The first randomised trial of colonoscopy screening: being invited cut the risk of bowel cancer by about a fifth, but fewer than half of those invited attended, so the effect on deaths was small.","summary":"84,585 people were randomised; only 42% of the invited group had a colonoscopy. In the intention-to-screen analysis at 10 years, colorectal cancer risk was 0.98% in the invited group versus 1.20% in the usual-care group (risk ratio 0.82), and colorectal cancer death 0.28% versus 0.31% (risk ratio 0.90, not significant). Adjusted per-protocol analysis estimated a 31% reduction in cancer incidence and a 50% reduction in death among those who actually attended. The trial (NEJM 2022) reframed colonoscopy as a strong test but a weak programme where participation is low, strengthening the case for FIT-based programmes.","status":"mixed","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT00883792","url":"https://clinicaltrials.gov/study/NCT00883792"},{"label":"NordICC (NEJM 2022)","url":"https://doi.org/10.1056/NEJMoa2208375"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["colorectal-screening"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["fit-test","screening"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nordicc-nejm-2022","paper-nordicc-lancet-2026-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00883792","phase":"3","setting":"Population-based randomised trial of invitation to a single screening colonoscopy versus no invitation in Poland, Norway and Sweden, adults aged 55 to 64","sponsor":"University of Oslo and partners","result":"10-year colorectal cancer risk 0.98% vs 1.20% (RR 0.82) by invitation; mortality RR 0.90, not significant.","started":"2009-05","yearReported":2022,"enrolled":84585,"enrolledBasis":"analysed","enrolledNote":"ClinicalTrials.gov lists 95,000 participants (actual); the NEJM 2022 analysis covers the 84,585 participants in Poland, Norway and Sweden with follow-up data (28,220 invited, 56,365 usual care).","outcomes":[{"endpoint":"Colorectal cancer incidence at 10 years (intention to screen)","primary":true,"unit":"%","arms":[{"name":"Invited to colonoscopy","value":0.98},{"name":"Usual care","value":1.2}],"hr":0.82,"ci":[0.7,0.93],"source":"https://doi.org/10.1056/NEJMoa2208375"},{"endpoint":"Colorectal cancer death at 10 years","unit":"%","arms":[{"name":"Invited to colonoscopy","value":0.28},{"name":"Usual care","value":0.31}],"hr":0.9,"ci":[0.64,1.16],"source":"https://doi.org/10.1056/NEJMoa2208375"}]},{"id":"nct04335669","kind":"trial","name":"NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC","aka":[],"tldr":"A phase 3 trial of epirubicin, cyclophosphamide, paclitaxel / nab-paclitaxel, carboplatin and other drugs in triple-negative breast cancer, run by Lund University Hospital, active but no longer recruiting.","summary":"NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC is a phase 3, randomised interventional study registered as NCT04335669 by Lund University Hospital, with a registry enrolment figure of 325 participants, started 2019-12-20 and due to reach its primary completion in 2035-09. Interventions recorded: epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab; epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab. Conditions listed: Breast Cancer; Triple Negative Breast Neoplasms. Sites: Denmark, Sweden. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04335669","url":"https://clinicaltrials.gov/study/NCT04335669"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["epirubicin","cyclophosphamide","paclitaxel","carboplatin","pembrolizumab","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04335669","phase":"3","setting":"A Translational Randomized Phase III Study Exploring the Effect of the Addition of Capecitabine to Carboplatine Based Chemotherapy in Early \"Triple Negative\" Breast Cancer","sponsor":"Lund University Hospital","started":"2019-12-20","startedType":"actual","enrolled":325,"enrolledBasis":"registry","outcomes":[]},{"id":"norpact-1","kind":"trial","name":"NORPACT-1","aka":["NorPACT-1","Nordic Pancreatic Cancer Trial-1"],"tldr":"NORPACT-1 asked whether giving FOLFIRINOX chemotherapy before surgery helps people whose pancreatic cancer can be removed straight away; it did not, and patients who went straight to surgery were if anything more likely to be alive at 18 months, so upfront surgery remains the standard for clearly resectable disease.","summary":"NORPACT-1 was a Nordic multicentre randomised phase 2 trial in 140 patients with resectable pancreatic head cancer, assigned to four cycles of neoadjuvant FOLFIRINOX then surgery and adjuvant chemotherapy (77) or upfront surgery and adjuvant chemotherapy (63). The primary endpoint was the proportion alive at 18 months by intention to treat.\n\nAt 18 months 60 percent of the neoadjuvant group were alive against 73 percent of the upfront surgery group, and median overall survival was 25.1 against 38.5 months (hazard ratio 1.52); resection rates were similar (82 against 89 percent) and grade 3 or worse adverse events were more frequent with neoadjuvant treatment. With PREOPANC on the other side of the argument, NORPACT-1 is the evidence the corpus's resectable pancreatic cancer page cites against routine neoadjuvant chemotherapy for clearly resectable tumours.","status":"negative","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02919787","url":"https://clinicaltrials.gov/study/NCT02919787"}],"tags":["soc-trials"],"related":[],"cancers":["resectable-pdac","pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["folfirinox","fluorouracil","oxaliplatin","irinotecan"],"companies":[],"institutions":["oslo-radium-hospital","karolinska"],"pathways":[],"terms":["pancreatic-failed-programmes"],"trials":["alliance-a021806","preopanc-3","swog-s1505","neonax"],"people":[],"bottlenecks":[],"keyPapers":["paper-norpact-1-neoadjuvant-folfirinox-labori-lancet-gastroenterol-hepatol-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02919787","phase":"2","setting":"Resectable pancreatic head cancer in Norway, Sweden, Denmark and Finland: four cycles of neoadjuvant FOLFIRINOX followed by surgery and adjuvant chemotherapy, against upfront surgery and adjuvant chemotherapy, with overall survival at 18 months as the primary endpoint","sponsor":"Oslo University Hospital","result":"Alive at 18 months: 60 percent with neoadjuvant FOLFIRINOX against 73 percent with upfront surgery (p 0.032); median overall survival 25.1 against 38.5 months (hazard ratio 1.52, p 0.050).","started":"2016-09","startedType":"actual","yearReported":2024,"enrolled":140,"enrolledBasis":"registry","outcomes":[{"endpoint":"Alive at 18 months (intention to treat)","primary":true,"unit":"%","arms":[{"name":"Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy","n":77,"value":60,"note":"95% CI 49 to 71"},{"name":"Upfront surgery, adjuvant chemotherapy","n":63,"value":73,"note":"95% CI 62 to 84"}],"p":"0.032","source":"https://doi.org/10.1016/S2468-1253(23)00405-3"},{"endpoint":"Overall survival (intention to treat)","unit":"months","arms":[{"name":"Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy","n":77,"value":25.1,"note":"95% CI 17.2 to 34.9"},{"name":"Upfront surgery, adjuvant chemotherapy","n":63,"value":38.5,"note":"95% CI 27.6 to not reached"}],"hr":1.52,"ci":[1,2.33],"p":"0.050","source":"https://doi.org/10.1016/S2468-1253(23)00405-3"},{"endpoint":"Resection rate","unit":"%","arms":[{"name":"Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy","n":77,"value":82},{"name":"Upfront surgery, adjuvant chemotherapy","n":63,"value":89}],"p":"0.24","source":"https://doi.org/10.1016/S2468-1253(23)00405-3"},{"endpoint":"Patients with at least one grade 3 or worse adverse event (safety population)","unit":"%","arms":[{"name":"Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy","n":73,"value":58},{"name":"Upfront surgery, adjuvant chemotherapy","n":47,"value":40}],"source":"https://doi.org/10.1016/S2468-1253(23)00405-3"}]},{"id":"notable-trial","kind":"trial","name":"NOTABLE (nimotuzumab, KRAS wild-type pancreatic cancer)","aka":[],"tldr":"In the minority of pancreatic cancers without a KRAS mutation, adding the EGFR antibody nimotuzumab to gemcitabine helped people live longer, and China approved it in 2023.","summary":"NOTABLE randomised patients in China with KRAS wild-type locally advanced or metastatic pancreatic cancer to nimotuzumab or placebo with gemcitabine. Overall survival, the primary endpoint, was longer with nimotuzumab, with the benefit concentrated in patients who had not had biliary obstruction. On this trial China's regulator approved nimotuzumab for KRAS wild-type pancreatic cancer in 2023, the first EGFR-directed approval in the disease since erlotinib.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02395016","url":"https://clinicaltrials.gov/study/NCT02395016"},{"label":"Qin et al., Journal of Clinical Oncology 2023: nimotuzumab plus gemcitabine for K-Ras wild-type pancreatic cancer (NOTABLE)","url":"https://doi.org/10.1200/JCO.22.02630"}],"tags":[],"related":[],"cancers":["pancreatic","kras-wild-type-pdac"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["egfr","kras"],"drugs":["nimotuzumab","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-qin-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02395016","phase":"3","setting":"Locally advanced or metastatic KRAS wild-type pancreatic cancer: nimotuzumab plus gemcitabine versus placebo plus gemcitabine","sponsor":"Biotech Pharmaceutical (China)","result":"Overall survival improved with nimotuzumab plus gemcitabine in KRAS wild-type disease.","started":"2015-04","startedType":"actual","yearReported":2023,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nimotuzumab + gemcitabine","n":41,"value":10.9,"note":"Restricted mean survival time 18.05 vs 11.14 months, ratio 0.62 (95% CI 0.40-0.97), p = 0.036; 82 eligible KRAS wild-type patients in the full analysis set"},{"name":"Placebo + gemcitabine","n":41,"value":8.5}],"p":"0.036","source":"https://doi.org/10.1200/JCO.22.02630"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Nimotuzumab + gemcitabine","value":4.2},{"name":"Placebo + gemcitabine","value":3.6}],"hr":0.6,"ci":[0.37,0.99],"p":"0.04","source":"https://doi.org/10.1200/JCO.22.02630"}]},{"id":"nottingham-fob","kind":"trial","name":"Nottingham faecal occult blood screening trial","aka":["ISRCTN11631712"],"tldr":"The Nottingham trial that proved a home stool test posted to a whole population reduces deaths from bowel cancer, and so created the NHS screening programme.","summary":"Between 1981 and 1991 Nottingham randomised 152,850 people to be offered a Haemoccult faecal occult blood test every two years or to nothing at all; the control group were not even told. Fewer than six in ten of those offered screening completed at least one test, and only 38 percent completed every test they were offered. Even so, 20 percent of the cancers found in the screened group were stage A against 11 percent in the control group, and after a median 7.8 years there were 360 colorectal cancer deaths in the screened group against 420 in the control group, a 15 percent reduction (odds ratio 0.85, 0.74 to 0.98, p = 0.026). The authors concluded that a national programme should be considered. It began in England in 2006.","status":"positive","asOf":"2026-09-24","links":[{"label":"Lancet 1996","url":"https://europepmc.org/article/MED/8942775"},{"label":"ISRCTN11631712","url":"https://www.isrctn.com/ISRCTN11631712"}],"tags":["uk","screening","colorectal"],"related":[],"cancers":["colorectal"],"sections":["early-detection","prevention"],"technologies":["colorectal-screening"],"targets":[],"drugs":[],"companies":["mrc-ctu"],"institutions":["nottingham-cancer-centre"],"pathways":[],"terms":["fit-test"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN11631712","phase":"3","setting":"Unselected population-based randomised trial of biennial faecal occult blood screening against no screening in 152,850 people aged 45 to 74 living in the Nottingham area, recruited February 1981 to January 1991, screening stopped February 1995","sponsor":"Medical Research Council","result":"Colorectal cancer deaths 360 in the screened group against 420 in the control group, a 15 percent reduction in cumulative mortality (odds ratio 0.85, 0.74 to 0.98, p = 0.026).","yearReported":1996,"enrolled":152850,"enrolledBasis":"randomised","enrolledNote":"152,850 people were recruited between February 1981 and January 1991; 2,599 could not be traced or had emigrated, leaving 150,251 in the analysis.","outcomes":[]},{"id":"nct04041310","kind":"trial","name":"Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by Nouscom SRL, active and no longer recruiting.","summary":"Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors is a phase 1/2 interventional study registered as NCT04041310 by Nouscom SRL, with 115 participants enrolled, started 2019-10-21 and due to reach its primary completion in 2026-10-30. Interventions recorded: GAd-209-FSP low dose, MVA-209-FSP low dose, GAd-209-FSP high dose, MVA-209-FSP high dose, GAd20-209-FSP, RP2D and MVA-209-FSP, RP2D.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04041310","url":"https://clinicaltrials.gov/study/NCT04041310"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["nouscom","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04041310","phase":"1/2","setting":"A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors","sponsor":"Nouscom SRL","started":"2019-10-21","startedType":"actual","enrolled":115,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05702229","kind":"trial","name":"Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","aka":[],"tldr":"A phase 2 trial of Rilvegostomig, CAPOX (capecitabine, oxaliplatin) and Capecitabine in gastric & gastro-oesophageal junction cancer, run by AstraZeneca, now recruiting.","summary":"Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma is a phase 2 interventional study registered as NCT05702229 by AstraZeneca, with 163 participants planned, started 2023-01-16 and due to reach its primary completion in 2027-11-30. Interventions recorded: Rilvegostomig, Volrustomig, FOLFOX, XELOX, AZD0901 and 5-Fluorouracil.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05702229","url":"https://clinicaltrials.gov/study/NCT05702229"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":[],"targets":[],"drugs":["rilvegostomig","capox","capecitabine"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05702229","phase":"2","setting":"An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","sponsor":"AstraZeneca","started":"2023-01-16","startedType":"actual","enrolled":163,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06342037","kind":"trial","name":"NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial","aka":["TONIC-3"],"tldr":"A phase 2 trial of tiragolumab, atezolizumab and ipilimumab in triple-negative breast cancer, run by The Netherlands Cancer Institute, now recruiting.","summary":"NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial is a phase 2, randomised interventional study registered as NCT06342037 by The Netherlands Cancer Institute, with a registry enrolment figure of 60 participants, started 2024-06-12 and due to reach its primary completion in 2026-04-01. Interventions recorded: Tiragolumab; Atezolizumab; Ipilimumab. Conditions listed: Metastatic Breast Cancer. Triple-negative eligibility wording from the registry: \"* Metastatic or incurable locally advanced triple negative breast cancer with confirmation of Estrogen receptor (ER) and Human Epidermal growth factor Receptor 2 (HER2) negativity (ER \\<10%, HER2 IHC 0, 1+ or 2+ with no amplification) on a histological biopsy of a metastatic lesion\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06342037","url":"https://clinicaltrials.gov/study/NCT06342037"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tiragolumab","atezolizumab","ipilimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06342037","phase":"2","setting":"NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial","sponsor":"The Netherlands Cancer Institute","started":"2024-06-12","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05485766","kind":"trial","name":"Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of pembrolizumab, paclitaxel / nab-paclitaxel, carboplatin and olaparib in triple-negative breast cancer, run by Okayama University, now recruiting.","summary":"Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer is a phase 2, interventional study registered as NCT05485766 by Okayama University, with a registry enrolment figure of 23 participants, started 2024-07-16 and due to reach its primary completion in 2028-06-30. Interventions recorded: Pembrolizumab; Paclitaxel; Carboplatin; Olaparib; Definitive Surgery. Conditions listed: Triple Negative Breast Neoplasms; Triple Negative Breast Cancer; Breast Neoplasms; Breast Cancer; BRCA1 Mutation; BRCA2 Mutation; BRCA Mutation; BRCA-Associated Breast Carcinoma. Triple-negative eligibility wording from the registry: \"* Have histologically confirmed TNBC, as defined by the most recent ASCO/CAP guidelines\". Sites: Japan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05485766","url":"https://clinicaltrials.gov/study/NCT05485766"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","parp-inhibitor","platinum"],"targets":[],"drugs":["pembrolizumab","paclitaxel","carboplatin","olaparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05485766","phase":"2","setting":"Neoadjuvant and Adjuvant Olaparib Plus Pembrolizumab Following Platinum Based Chemotherapy Plus Pembrolizumab for Germline BRCA Mutated Triple Negative Breast Cancer (WJOG14020B/OPERETTA)","sponsor":"Okayama University","started":"2024-07-16","startedType":"actual","enrolled":23,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05023486","kind":"trial","name":"NP-G2-044 as Monotherapy and Combination Therapy in Patients With Advanced or Metastatic Solid Tumor Malignancies","aka":[],"tldr":"A phase 1/2 trial of NP-G2-044 Monotherapy in advanced solid tumours, run by Novita Pharmaceuticals, Inc., active and no longer recruiting.","summary":"NP-G2-044 as Monotherapy and Combination Therapy in Patients With Advanced or Metastatic Solid Tumor Malignancies is a phase 1/2 interventional study registered as NCT05023486 by Novita Pharmaceuticals, Inc., with 121 participants enrolled, started 2021-12-07 and due to reach its primary completion in 2026-06-30. Interventions recorded: NP-G2-044 Monotherapy, Anti-PD-1 Therapy and NP-G2-044 Combination therapy.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05023486","url":"https://clinicaltrials.gov/study/NCT05023486"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["pd1"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05023486","phase":"1/2","setting":"NP-G2-044 as Monotherapy and Combination Therapy in Patients With Advanced or Metastatic Solid Tumor Malignancies","sponsor":"Novita Pharmaceuticals, Inc.","started":"2021-12-07","startedType":"actual","enrolled":121,"enrolledBasis":"registry","outcomes":[]},{"id":"nrg-cc001","kind":"trial","name":"NRG CC001","aka":[],"tldr":"NRG CC001 showed that shaping whole-brain radiotherapy to spare the hippocampus, the seat of memory, reduces cognitive decline without any loss of tumour control.","summary":"NRG CC001 randomised 518 patients with brain metastases to whole-brain radiotherapy (30 Gy in ten fractions) with or without hippocampal avoidance, both with memantine. The risk of cognitive failure was lower with hippocampal avoidance (hazard ratio 0.74), with less deterioration in executive function at four months and in learning and memory at six months, and no difference in intracranial progression or survival (Brown and colleagues, Journal of Clinical Oncology 2020). Hippocampal avoidance with memantine is now the standard when whole-brain radiotherapy is needed.","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02360215","url":"https://clinicaltrials.gov/study/NCT02360215"},{"label":"JCO 2020","url":"https://doi.org/10.1200/JCO.19.02767"}],"tags":["radiation-wave2"],"related":[],"cancers":["brain-tumours","metastatic-cancer","secondary-brain-tumours"],"sections":[],"technologies":["imrt-igrt","vmat"],"targets":[],"drugs":["memantine"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":["wbrt","organs-at-risk"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02360215","phase":"3","setting":"Brain metastases needing whole-brain radiotherapy: hippocampal-avoidance whole-brain radiotherapy plus memantine versus standard whole-brain radiotherapy plus memantine","sponsor":"NRG Oncology","result":"Cognitive failure hazard ratio 0.74 with hippocampal avoidance; no difference in intracranial control or survival.","started":"2015-07","startedType":"actual","yearReported":2020,"enrolled":518,"enrolledBasis":"registry","outcomes":[{"endpoint":"Time to cognitive function failure","primary":true,"arms":[{"name":"Hippocampal-avoidance WBRT + memantine"},{"name":"WBRT + memantine"}],"hr":0.74,"ci":[0.58,0.95],"p":"0.02","source":"https://doi.org/10.1200/JCO.19.02767"},{"endpoint":"Deterioration in executive function at 4 months","unit":"%","arms":[{"name":"Hippocampal-avoidance WBRT + memantine","value":23.3},{"name":"WBRT + memantine","value":40.4}],"p":"0.01","source":"https://doi.org/10.1200/JCO.19.02767"}]},{"id":"rtog-0521","kind":"trial","name":"NRG Oncology RTOG 0521","aka":["RTOG 0521","NRG/RTOG 0521"],"tldr":"Adding chemotherapy to hormone therapy and radiotherapy for the most aggressive localised prostate cancer improved four-year survival from 89 to 93 percent.","summary":"RTOG 0521 enrolled 612 men with high-risk non-metastatic prostate cancer between 2005 and 2009; 563 were evaluable. Median PSA was 15.1 ng/mL, 53 percent had a Gleason score of 9 to 10 and 27 percent had cT3 to cT4 disease. Men were randomised to standard long-term androgen suppression with radiotherapy, with or without adjuvant docetaxel.\n\nAt a median 5.7 years, 4-year overall survival was 89 percent (95 percent confidence interval 84 to 92) without chemotherapy and 93 percent (90 to 96) with it, hazard ratio 0.69 (90 percent confidence interval 0.49 to 0.97, one-sided p=0.034). There were 59 deaths without chemotherapy and 43 with it, and fewer of those deaths were from prostate cancer (23 against 16). The 6-year rate of distant metastasis was 14 percent without and 9.1 percent with chemotherapy, hazard ratio 0.60 (0.37 to 0.99, two-sided p=0.044), and 6-year disease-free survival was 55 against 65 percent, hazard ratio 0.76 (0.58 to 0.99, p=0.043).\n\nTreatment was well tolerated in both arms. The authors framed the result carefully, as an option to be discussed with selected men rather than a new standard, and it has not displaced abiraterone, which the STAMPEDE high-risk non-metastatic comparison later showed improves metastasis-free survival with a hazard ratio of 0.53.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00288080","url":"https://clinicaltrials.gov/study/NCT00288080"},{"label":"RTOG 0521 (Journal of Clinical Oncology 2019)","url":"https://doi.org/10.1200/JCO.18.02158"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":["cytotoxic-chemotherapy","androgen-deprivation","imrt-igrt"],"targets":[],"drugs":["docetaxel"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":["adt","curative-intent","gleason-grade-group"],"trials":["stampede","chaarted"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00288080","phase":"3","setting":"High-risk non-metastatic prostate cancer: long-term androgen suppression with radiotherapy, with or without adjuvant docetaxel chemotherapy, with overall survival as the primary endpoint","sponsor":"NRG Oncology and the Radiation Therapy Oncology Group, funded by the National Cancer Institute","result":"Four-year overall survival 93 against 89 percent with adjuvant docetaxel added to androgen suppression and radiotherapy (hazard ratio 0.69, 90 percent confidence interval 0.49 to 0.97); 6-year distant metastasis 9.1 against 14 percent.","started":"2005-12","yearReported":2019,"enrolled":612,"enrolledBasis":"randomised","enrolledNote":"612 men were enrolled between 2005 and 2009 and 563 were evaluable; the evaluable figure is the one analysed.","outcomes":[{"endpoint":"Overall survival at 4 years","primary":true,"unit":"%","arms":[{"name":"Androgen suppression, radiotherapy and docetaxel","value":93,"note":"Confidence interval is 90 percent, as prespecified."},{"name":"Androgen suppression and radiotherapy","value":89}],"hr":0.69,"ci":[0.49,0.97],"p":"0.034 one-sided","source":"https://doi.org/10.1200/JCO.18.02158"},{"endpoint":"Distant metastasis at 6 years","unit":"%","arms":[{"name":"Androgen suppression, radiotherapy and docetaxel","value":9.1},{"name":"Androgen suppression and radiotherapy","value":14}],"hr":0.6,"ci":[0.37,0.99],"p":"0.044","source":"https://doi.org/10.1200/JCO.18.02158"}],"replication":"GETUG-AFU 12 found a disease-free survival benefit for docetaxel in the same setting but no overall survival benefit; the STAMPEDE high-risk non-metastatic comparison of abiraterone gave a larger metastasis-free survival effect (hazard ratio 0.53)."},{"id":"nrg-gy018-keynote-868","kind":"trial","name":"NRG-GY018 / KEYNOTE-868","aka":[],"tldr":"NRG-GY018 is the pembrolizumab twin of RUBY: immunotherapy plus chemotherapy cut the risk of progression by 70% in dMMR tumours and 46% in the rest.","summary":"NRG-GY018, also KEYNOTE-868, trial NCT03914612 run by NRG Oncology with Merck support and published in the New England Journal of Medicine in 2023, is the pembrolizumab twin of RUBY: adding immunotherapy to carboplatin and paclitaxel, followed by pembrolizumab maintenance, cut the risk of progression by seventy percent in mismatch-repair-deficient advanced or recurrent endometrial cancer and by nearly half in the rest. It randomised 816 patients analysed by mismatch repair status, met its primary progression-free survival endpoint in both cohorts, and led to FDA approval in June 2024 regardless of mismatch repair status. OnCo links it to endometrial cancer, PD-1 as a target, pembrolizumab, NRG Oncology, the dMMR term, Ramez N. Eskander and the pairing of chemotherapy with PD-1 blockade. Whether mismatch-repair-proficient patients gain a survival benefit is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03914612","url":"https://clinicaltrials.gov/study/NCT03914612"},{"label":"NEJM 2023","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2302312"}],"tags":[],"related":[],"cancers":["endometrial","endometrial-mmr-deficient","advanced-recurrent-endometrial-cancer","endometrial-nsmp"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab","carboplatin","paclitaxel"],"companies":["nrg-oncology","gog-foundation"],"institutions":[],"pathways":[],"terms":["msi"],"trials":[],"people":["ramez-eskander"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03914612","phase":"3","setting":"Advanced or recurrent endometrial cancer: pembrolizumab + carboplatin-paclitaxel then pembrolizumab maintenance vs chemotherapy, analysed by MMR status","sponsor":"NRG Oncology / Merck","result":"PFS HR 0.30 (dMMR), 0.54 (pMMR).","started":"2019-08-22","startedType":"actual","yearReported":2023,"enrolled":816,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (dMMR)","primary":true,"unit":"HR","arms":[{"name":"Pembrolizumab + chemo","n":112},{"name":"Placebo + chemo","n":113}],"hr":0.3,"ci":[0.19,0.48],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2302312"},{"endpoint":"Progression-free survival (pMMR)","primary":true,"unit":"HR","arms":[{"name":"Pembrolizumab + chemo","n":294},{"name":"Placebo + chemo","n":294}],"hr":0.54,"ci":[0.41,0.71],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2302312"}]},{"id":"nrg-hn002-hn005","kind":"trial","name":"NRG-HN002 & NRG-HN005 (HPV+ de-escalation)","aka":[],"tldr":"Attempts to give HPV-positive throat cancer patients less radiation fell short: the standard dose remained better, so de-escalation is not yet routine.","summary":"HN002 (phase 2, 2021) found 60 Gy with weekly cisplatin met its acceptability threshold, but 60 Gy alone did not. HN005 (phase 2/3, presented 2025) was stopped after the de-intensified arms showed diminished progression-free survival while the 70 Gy control reached 2-year PFS of 98%. HPV status alone is an insufficient selector; ctHPV-DNA and imaging-response-adapted designs are the next approach.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03952585","url":"https://clinicaltrials.gov/study/NCT03952585"},{"label":"NRG Oncology HN005 summary","url":"https://www.nrgoncology.org/Home/News/Post/treatment-de-intensification-for-early-stage-hpv-positive-oropharyngeal-cancer-nrg-hn005/"}],"tags":["lesson:de-escalation-needs-better-selection"],"related":[],"cancers":["head-and-neck","oropharyngeal-cancer","hpv-positive-oropharyngeal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":["hpv-p16"],"trials":[],"people":["quynh-thu-le"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03952585","phase":"2/3","setting":"Low-risk HPV-positive oropharyngeal cancer: reduced-dose radiation (60 Gy) with or without cisplatin, or with nivolumab, vs standard 70 Gy chemoradiation","sponsor":"NRG Oncology / NCI","result":"HN005: de-escalated arms had worse PFS; control 2-year PFS 98%.","started":"2019-10-09","startedType":"actual","yearReported":2025,"enrolledBasis":"registry","outcomes":[{"endpoint":"HN005: progression-free survival at 2 years (phase II non-inferiority)","primary":true,"unit":"%","arms":[{"name":"70 Gy + cisplatin (standard)","n":136,"value":98.1,"note":"Both de-escalated arms failed non-inferiority (HR vs standard 7.42 and 5.55; non-inferiority margin HR 2.4); the trial did not proceed to phase III"},{"name":"60 Gy + cisplatin","n":116,"value":88.6},{"name":"60 Gy + nivolumab","n":132,"value":90.3}],"source":"https://clinicaltrials.gov/study/NCT03952585"},{"endpoint":"HN002: progression-free survival at 2 years (randomised phase II vs 85% historical control)","unit":"%","arms":[{"name":"60 Gy IMRT + weekly cisplatin","value":90.5,"note":"306 patients; only the cisplatin arm met the PFS and swallowing (MDADI) criteria to advance"},{"name":"60 Gy IMRT alone","value":87.6}],"p":"0.04 (IMRT + cisplatin vs 85%)","source":"https://ascopubs.org/doi/10.1200/JCO.20.03128"}],"replication":"HN005 confirmed the HN002 lesson in a randomised comparison: unselected dose de-escalation in HPV-positive oropharynx cancer costs disease control, consistent with the negative De-ESCALaTE and RTOG 1016 cetuximab-substitution trials."},{"id":"nsabp-b04","kind":"trial","name":"NSABP B-04","aka":["National Surgical Adjuvant Breast and Bowel Project B-04","NSABP B04"],"tldr":"The trial that took the radical out of radical mastectomy. Removing the chest muscles and clearing every node did not help women live longer, and neither did removing nodes that had cancer in them but were not causing trouble. It is the first evidence that breast cancer spreads early through the bloodstream rather than marching outward node by node.","summary":"NSABP B-04 opened in 1971 to test William Halsted's theory directly. 1,079 women with clinically negative axillary nodes were randomised three ways, to radical mastectomy, to total mastectomy with postoperative irradiation, or to total mastectomy with axillary dissection only if nodes later became positive. A further 586 women with clinically positive nodes were randomised to radical mastectomy or to total mastectomy with irradiation.\n\nAt twenty-five years there were no significant differences among any of the groups in disease-free survival, relapse-free survival, distant-disease-free survival or overall survival. Among node-negative women, the hazard ratio for death after total mastectomy with radiation against radical mastectomy was 1.08 (95 percent confidence interval 0.91 to 1.28, p=0.38), and after total mastectomy without radiation 1.03 (0.87 to 1.23, p=0.72). Among node-positive women it was 1.06 (0.89 to 1.27, p=0.49).\n\nThe result that matters most is the one about the axilla, and the authors state it plainly: the findings fail to show a significant survival advantage either from removing occult positive nodes at the initial operation or from irradiating them. Differences of a few percentage points cannot be excluded, which is the honest limit of the trial. Every subsequent axillary de-escalation trial, from NSABP B-32 to Z0011 to SENOMAC, is a refinement of the question B-04 asked first.","status":"positive","asOf":"2026-09-25","links":[{"label":"NSABP B-04 twenty-five-year follow-up (New England Journal of Medicine 2002)","url":"https://doi.org/10.1056/NEJMoa020128"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["nsabp-foundation","nrg-oncology"],"institutions":[],"pathways":[],"terms":["mastectomy","lymphadenectomy","axillary-surgery-de-escalation","post-mastectomy-radiotherapy"],"trials":["nsabp-b06","nsabp-b32","acosog-z0011"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Operable breast cancer: Halsted radical mastectomy against total mastectomy with postoperative irradiation against total mastectomy with axillary dissection only if the nodes became positive, reported at twenty-five years","sponsor":"National Surgical Adjuvant Breast and Bowel Project","result":"No significant difference in disease-free, relapse-free, distant-disease-free or overall survival between radical mastectomy, total mastectomy with irradiation and total mastectomy alone, at twenty-five years.","yearReported":2002,"enrolled":1665,"enrolledBasis":"randomised","enrolledNote":"1,079 women with clinically negative nodes and 586 with clinically positive nodes, 1,665 in all, were randomised from 1971; the trial predates the registries, so there is no registry figure.","outcomes":[{"endpoint":"Death from any cause at 25 years, node-negative women: total mastectomy with radiation against radical mastectomy","primary":true,"unit":"hazard ratio","arms":[{"name":"Total mastectomy with irradiation against radical mastectomy","value":1.08}],"hr":1.08,"ci":[0.91,1.28],"p":"0.38","source":"https://doi.org/10.1056/NEJMoa020128"},{"endpoint":"Death from any cause at 25 years, node-negative women: total mastectomy alone against radical mastectomy","unit":"hazard ratio","arms":[{"name":"Total mastectomy alone against radical mastectomy","value":1.03}],"hr":1.03,"ci":[0.87,1.23],"p":"0.72","source":"https://doi.org/10.1056/NEJMoa020128"},{"endpoint":"Death from any cause at 25 years, node-positive women","unit":"hazard ratio","arms":[{"name":"Total mastectomy with irradiation against radical mastectomy","value":1.06}],"hr":1.06,"ci":[0.89,1.27],"p":"0.49","source":"https://doi.org/10.1056/NEJMoa020128"}],"replication":"NSABP B-06 confirmed that the extent of breast surgery does not change survival; the axillary conclusion was confirmed prospectively by NSABP B-32, ACOSOG Z0011, AMAROS and SENOMAC."},{"id":"nsabp-b06","kind":"trial","name":"NSABP B-06","aka":["National Surgical Adjuvant Breast and Bowel Project B-06","NSABP B06"],"tldr":"This is the trial that ended the routine mastectomy. Twenty years on, women who kept their breast lived exactly as long as those who lost it, and the radiotherapy that went with breast conservation cut the chance of the cancer coming back in that breast from about two in five to about one in seven.","summary":"Bernard Fisher opened NSABP B-06 in 1976 to ask a question the surgical profession regarded as settled: whether removing the lump was as good as removing the breast. 1,851 women with tumours of 4 cm or less were randomised three ways, to total mastectomy, to lumpectomy alone, or to lumpectomy followed by breast irradiation; all node-positive women received chemotherapy.\n\nAt twenty years the cumulative incidence of a recurrence in the treated breast was 14.3 percent after lumpectomy with irradiation against 39.2 percent after lumpectomy alone (p<0.001). That gap is the case for radiotherapy. The case for conservation is what did not differ: there was no significant difference between the three groups in disease-free survival, distant-disease-free survival or overall survival. The hazard ratio for death after lumpectomy alone against total mastectomy was 1.05 (95 percent confidence interval 0.90 to 1.23, p=0.51), and after lumpectomy with irradiation 0.97 (0.83 to 1.14, p=0.74).\n\nOne detail is easy to miss and matters for how radiotherapy is discussed today. Among women with tumour-free margins, irradiation gave a hazard ratio for death of 0.91 (0.77 to 1.06, p=0.23): a marginally significant fall in breast cancer deaths that was partly offset by a rise in deaths from other causes. The benefit of breast radiotherapy is real, and it is not free.\n\nThe condition Fisher attached to the conclusion is still the condition today: conservation is appropriate provided the margins are clear and an acceptable cosmetic result can be obtained.","status":"positive","asOf":"2026-09-25","links":[{"label":"NSABP B-06 twenty-year follow-up (New England Journal of Medicine 2002)","url":"https://doi.org/10.1056/NEJMoa022152"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["nsabp-foundation","nrg-oncology"],"institutions":[],"pathways":[],"terms":["lumpectomy","mastectomy","resection-margins","breast-conserving-surgery-versus-mastectomy"],"trials":["milan-i","eortc-10801","nsabp-b04"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Invasive breast cancer up to 4 cm, node-positive or node-negative: total mastectomy against lumpectomy alone against lumpectomy with breast irradiation, with disease-free, distant-disease-free and overall survival as the endpoints","sponsor":"National Surgical Adjuvant Breast and Bowel Project","result":"Twenty-year recurrence in the treated breast 14.3 percent with lumpectomy and irradiation against 39.2 percent with lumpectomy alone; no difference in overall survival between any of the three operations.","yearReported":2002,"enrolled":1851,"enrolledBasis":"analysed","enrolledNote":"The trial opened in 1976 and has no registry record; 1,851 women with follow-up data and known nodal status were analysed in the twenty-year report.","outcomes":[{"endpoint":"Cumulative incidence of recurrent tumour in the ipsilateral breast at 20 years","primary":true,"unit":"%","arms":[{"name":"Lumpectomy plus breast irradiation","value":14.3},{"name":"Lumpectomy alone","value":39.2}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa022152"},{"endpoint":"Death from any cause at 20 years, lumpectomy alone against total mastectomy","unit":"hazard ratio","arms":[{"name":"Lumpectomy alone against total mastectomy","value":1.05}],"hr":1.05,"ci":[0.9,1.23],"p":"0.51","source":"https://doi.org/10.1056/NEJMoa022152"},{"endpoint":"Death from any cause at 20 years, lumpectomy with irradiation against total mastectomy","unit":"hazard ratio","arms":[{"name":"Lumpectomy plus irradiation against total mastectomy","value":0.97}],"hr":0.97,"ci":[0.83,1.14],"p":"0.74","source":"https://doi.org/10.1056/NEJMoa022152"}],"replication":"The Milan quadrantectomy trial, EORTC 10801 and three smaller European trials reached the same conclusion in different populations and with different operations; the EBCTCG overview of radiotherapy after breast-conserving surgery quantified the radiotherapy effect across 10,801 women in 17 trials."},{"id":"nsabp-b32","kind":"trial","name":"NSABP B-32","aka":["National Surgical Adjuvant Breast and Bowel Project B-32","NSABP B32"],"tldr":"The trial that made it safe to take one or two lymph nodes instead of twenty. Where the first node the cancer drains to is clear, clearing the rest of the armpit adds nothing to survival and adds a lifetime of arm swelling risk.","summary":"NSABP B-32 randomised 5,611 women with clinically node-negative invasive breast cancer at 80 centres in the United States and Canada between 1999 and 2004. Group 1 had sentinel node resection followed by axillary clearance whatever the sentinel node showed; group 2 had sentinel node resection alone, with clearance only if the sentinel node contained cancer. Mapping used both blue dye and a radioactive tracer. The primary endpoint was overall survival among the 3,989 patients whose sentinel nodes were negative.\n\nAt a mean 95.6 months, 309 deaths had occurred among the 3,986 sentinel node-negative patients with follow-up: 140 of 1,975 in group 1 and 169 of 2,011 in group 2. The unadjusted hazard ratio for overall survival was 1.20 (95 percent confidence interval 0.96 to 1.50, p=0.12), with eight-year estimates of 91.8 against 90.3 percent. Disease-free survival gave a hazard ratio of 1.05 (0.90 to 1.22, p=0.54), with eight-year estimates of 82.4 against 81.5 percent. Regional node recurrence as a first event occurred in eight patients in group 1 and fourteen in group 2 (p=0.22).\n\nB-32 is the largest trial of the sentinel node concept ever run, and its conclusion is unqualified: when the sentinel node is negative, sentinel node surgery alone is appropriate, safe and effective.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00003830","url":"https://clinicaltrials.gov/study/NCT00003830"},{"label":"NSABP B-32 overall survival (Lancet Oncology 2010)","url":"https://doi.org/10.1016/S1470-2045(10)70207-2"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["sentinel-node"],"targets":[],"drugs":[],"companies":["nsabp-foundation","nrg-oncology"],"institutions":[],"pathways":[],"terms":["sentinel-lymph-node-biopsy","lymphadenectomy","axillary-surgery-de-escalation","breast-cancer-related-lymphoedema"],"trials":["almanac","acosog-z0011","nsabp-b04"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003830","phase":"3","setting":"Invasive breast cancer with clinically negative nodes: sentinel node resection followed by axillary clearance in every patient, against sentinel node resection with clearance only if the sentinel node was positive, with overall survival as the primary endpoint","sponsor":"National Surgical Adjuvant Breast and Bowel Project","result":"Eight-year overall survival 90.3 percent with sentinel node biopsy alone against 91.8 percent with added clearance (hazard ratio 1.20, 0.96 to 1.50, p=0.12); regional recurrence 14 against 8 events.","started":"1999-05","yearReported":2010,"enrolled":5611,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 8 years (sentinel node-negative patients)","primary":true,"unit":"%","arms":[{"name":"Sentinel node resection alone","n":2011,"value":90.3,"note":"95 percent confidence interval 88.8 to 91.8"},{"name":"Sentinel node resection plus axillary clearance","n":1975,"value":91.8,"note":"95 percent confidence interval 90.4 to 93.3"}],"hr":1.2,"ci":[0.96,1.5],"p":"0.12","source":"https://doi.org/10.1016/S1470-2045(10)70207-2"},{"endpoint":"Disease-free survival at 8 years","unit":"%","arms":[{"name":"Sentinel node resection alone","n":2011,"value":81.5},{"name":"Sentinel node resection plus axillary clearance","n":1975,"value":82.4}],"hr":1.05,"ci":[0.9,1.22],"p":"0.54","source":"https://doi.org/10.1016/S1470-2045(10)70207-2"}],"replication":"ALMANAC, run in parallel in the United Kingdom, measured the morbidity side of the same question and found lymphoedema and sensory loss cut to about a third."},{"id":"nsabp-b39","kind":"trial","name":"NSABP B-39/RTOG 0413","aka":[],"tldr":"The largest partial-breast trial found recurrence rates within one percentage point of whole-breast treatment but could not formally prove equivalence, so accelerated partial-breast irradiation is offered to selected lower-risk women rather than everyone.","summary":"NSABP B-39/RTOG 0413 randomised 4,216 women with stage 0 to II breast cancer to whole-breast irradiation or accelerated partial-breast irradiation given twice daily over five to ten days by brachytherapy or external beam. Ten-year ipsilateral breast tumour recurrence was 4.6 percent with partial-breast and 3.9 percent with whole-breast treatment; the hazard ratio's confidence interval crossed the equivalence margin, so equivalence was not established, although the absolute difference was small (Vicini and colleagues, Lancet 2019).","status":"negative","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT00103181","url":"https://clinicaltrials.gov/study/NCT00103181"},{"label":"Lancet 2019","url":"https://doi.org/10.1016/S0140-6736(19)32514-0"}],"tags":["radiation-wave2"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive","tnbc","ductal-carcinoma-in-situ","breast-cancer"],"sections":[],"technologies":["hdr-brachytherapy","imrt-igrt"],"targets":[],"drugs":[],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":["partial-breast-irradiation"],"trials":["rapid","targit-a"],"people":[],"bottlenecks":[],"keyPapers":["paper-nsabp-b39-lancet-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00103181","phase":"3","setting":"Early breast cancer or DCIS after lumpectomy: accelerated partial-breast irradiation (twice daily over one week) versus whole-breast irradiation","sponsor":"NRG Oncology (NSABP and RTOG)","result":"10-year ipsilateral breast tumour recurrence 4.6% (partial breast) vs 3.9% (whole breast); equivalence not established.","started":"2005-03","yearReported":2019,"enrolled":4216,"enrolledBasis":"registry","outcomes":[{"endpoint":"Ipsilateral breast tumour recurrence at 10 years","primary":true,"unit":"%","arms":[{"name":"Accelerated partial-breast irradiation","n":2107,"value":4.6},{"name":"Whole-breast irradiation","n":2109,"value":3.9}]}]},{"id":"nsabp-b51","kind":"trial","name":"NSABP B-51 / RTOG 1304","aka":["NSABP B-51","RTOG 1304","NRG Oncology/NSABP B-51"],"tldr":"If chemotherapy given before surgery clears the lymph nodes completely, irradiating those nodes afterwards adds nothing. Fewer than one woman in ten had the cancer come back either way, and the difference between the two groups was within chance.","summary":"B-51 asked whether the response to chemotherapy, rather than the stage at diagnosis, should decide the radiotherapy. Patients with clinical T1 to T3, N1, M0 breast cancer and biopsy-proven axillary disease who reached pathologically node-negative status after chemotherapy were randomised to regional nodal irradiation or to none. 1,641 were enrolled and 1,556 were analysed, 772 in the irradiation group and 784 without.\n\nAfter a median 59.5 months there had been 109 primary endpoint events, 50 in the irradiation group and 59 without. Regional nodal irradiation did not significantly lengthen the invasive breast cancer recurrence-free interval (hazard ratio 0.88, 95 percent confidence interval 0.60 to 1.28, p=0.51), and the point estimates of survival free from those events were 92.7 and 91.8 percent. It did not improve the locoregional recurrence-free interval, the distant recurrence-free interval, disease-free survival or overall survival. No deaths were attributed to the protocol therapy; grade 4 adverse events occurred in 0.5 percent of the irradiation group and 0.1 percent of the other.\n\nThis is a negative trial in the useful sense: it removes a treatment. Roughly four in ten patients with node-positive disease at diagnosis reach a complete nodal response with modern chemotherapy, and for those patients B-51 says the nodes can be left alone. It is the radiotherapy counterpart of what ATNEC is asking about surgery.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01872975","url":"https://clinicaltrials.gov/study/NCT01872975"},{"label":"NSABP B-51/RTOG 1304 (New England Journal of Medicine 2025)","url":"https://doi.org/10.1056/NEJMoa2414859"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["nrg-oncology","nsabp-foundation"],"institutions":[],"pathways":[],"terms":["neoadjuvant-versus-adjuvant-breast","targeted-axillary-dissection","post-mastectomy-radiotherapy","pcr"],"trials":["atnec","acosog-z1071","supremo","ma-20"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01872975","phase":"3","setting":"Clinical T1 to T3, N1, M0 breast cancer with biopsy-proven axillary nodal disease that becomes pathologically node-negative after chemotherapy given before surgery: regional nodal irradiation against no regional nodal irradiation, with the invasive breast cancer recurrence-free interval as the primary endpoint","sponsor":"NRG Oncology and the NSABP Foundation, funded by the National Institutes of Health","result":"Regional nodal irradiation after a complete nodal response to chemotherapy did not lengthen the invasive breast cancer recurrence-free interval (hazard ratio 0.88, 0.60 to 1.28, p=0.51); event-free estimates 92.7 against 91.8 percent.","started":"2013-08","yearReported":2025,"enrolled":1641,"enrolledBasis":"registered","enrolledNote":"1,641 patients were enrolled and 1,556 were included in the primary-event analysis; the ClinicalTrials.gov record NCT01872975 gives an estimated 1,636.","outcomes":[{"endpoint":"Invasive breast cancer recurrence-free interval","primary":true,"unit":"hazard ratio","arms":[{"name":"Regional nodal irradiation","n":772,"value":0.88,"note":"50 events; point estimate of survival free from primary endpoint events 92.7 percent"},{"name":"No regional nodal irradiation","n":784,"note":"59 events; point estimate 91.8 percent"}],"hr":0.88,"ci":[0.6,1.28],"p":"0.51","source":"https://doi.org/10.1056/NEJMoa2414859"}],"replication":"ATNEC is asking the same question about axillary surgery rather than radiotherapy and is still recruiting."},{"id":"nct07669467","kind":"trial","name":"Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 3 trial of Nuvastatic 300 in triple-negative breast cancer, run by Natureceuticals Sdn Bhd, now recruiting.","summary":"Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer is a phase 3 interventional study registered as NCT07669467 by Natureceuticals Sdn Bhd, with 250 participants planned, started 2025-10-01 and due to reach its primary completion in 2026-10-30. Interventions recorded: Nuvastatic 300 and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07669467","url":"https://clinicaltrials.gov/study/NCT07669467"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["natureceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07669467","phase":"3","setting":"A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300 mg Capsules in Reducing Chemotherapy-Induced Fatigue in Patients With Metastatic Triple-Negative Breast Cancer Receiving Standard Chemotherapy","sponsor":"Natureceuticals Sdn Bhd","started":"2025-10-01","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07324304","kind":"trial","name":"NWRD06 DNA Plasmid for HCC After Curative Resection.","aka":[],"tldr":"A phase 2 trial of NWRD06 administered by electroporation in hepatocellular carcinoma, run by Newish Technology (Beijing) Co., Ltd., now recruiting.","summary":"NWRD06 DNA Plasmid for HCC After Curative Resection. is a phase 2 interventional study registered as NCT07324304 by Newish Technology (Beijing) Co., Ltd., with 30 participants planned, started 2025-12-08 and due to reach its primary completion in 2028-12-31. Interventions recorded: NWRD06 administered by electroporation.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07324304","url":"https://clinicaltrials.gov/study/NCT07324304"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07324304","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of NWRD06 in Patients With Hepatocellular Carcinoma After Curative Resection.","sponsor":"Newish Technology (Beijing) Co., Ltd.","started":"2025-12-08","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"oak","kind":"trial","name":"OAK","aka":[],"tldr":"The trial that put a PD-L1 antibody alongside the PD-1 antibodies as second-line treatment for lung cancer, in the largest second-line immunotherapy trial run.","summary":"OAK recruited 1,225 patients at 194 centres in 31 countries between March 2014 and April 2015 and randomised them 1:1 to atezolizumab 1200 mg or docetaxel 75 mg/m2 every three weeks. Eligible patients had squamous or non-squamous disease, performance status 0 or 1, and one or two previous cytotoxic regimens including at least one platinum combination; patients with autoimmune disease or previous checkpoint exposure were excluded. The primary efficacy analysis was prespecified in the first 850 enrolled, 425 per arm, with co-primary endpoints in the intention-to-treat population and in the PD-L1-expressing population (1 percent or more on tumour cells or tumour-infiltrating immune cells).\n\nMedian overall survival was 13.8 months (95 percent confidence interval 11.8 to 15.7) with atezolizumab against 9.6 months (8.6 to 11.2) with docetaxel (hazard ratio 0.73). The benefit held in both co-primary populations, including in patients whose tumours had no detectable PD-L1.\n\nThe FDA approved atezolizumab for metastatic non-small-cell lung cancer after platinum chemotherapy in 2016. In England NICE TA520 (16 May 2018) recommends atezolizumab after chemotherapy for locally advanced or metastatic disease.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02008227","url":"https://clinicaltrials.gov/study/NCT02008227"},{"label":"OAK (Lancet 2017)","url":"https://doi.org/10.1016/S0140-6736(16)32517-X"},{"label":"NICE TA520: atezolizumab for locally advanced or metastatic non-small-cell lung cancer after chemotherapy","url":"https://www.nice.org.uk/guidance/ta520"}],"tags":[],"related":[],"cancers":["nsclc","lung-squamous-cell-carcinoma","lung-adenocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":["pdl1"],"drugs":["atezolizumab","docetaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["immune-checkpoint","pd-l1-testing"],"trials":["checkmate-017","checkmate-057"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02008227","phase":"3","setting":"Squamous or non-squamous non-small-cell lung cancer after one or two previous cytotoxic regimens including a platinum doublet: atezolizumab 1200 mg versus docetaxel 75 mg/m2, both every three weeks, with co-primary overall survival endpoints in the intention-to-treat and PD-L1-expressing populations","sponsor":"Roche","result":"Median overall survival 13.8 against 9.6 months (hazard ratio 0.73), in both the intention-to-treat and PD-L1-expressing populations.","started":"2014-03-11","startedType":"actual","yearReported":2016,"enrolled":1225,"enrolledBasis":"randomised","enrolledNote":"1,225 patients were recruited; the primary efficacy analysis was prespecified in the first 850.","outcomes":[{"endpoint":"Overall survival (intention to treat)","primary":true,"unit":"months","arms":[{"name":"Atezolizumab","n":425,"value":13.8},{"name":"Docetaxel","n":425,"value":9.6}],"hr":0.73,"source":"https://doi.org/10.1016/S0140-6736(16)32517-X"}],"replication":"Consistent with CheckMate 017, CheckMate 057 and KEYNOTE-010; POPLAR was the randomised phase 2 that preceded it."},{"id":"nct05236946","kind":"trial","name":"Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Tata Memorial Hospital, now recruiting.","summary":"Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT is a phase 3, randomised interventional study registered as NCT05236946 by Tata Memorial Hospital, with a registry enrolment figure of 190 participants, started 2020-11-10 and due to reach its primary completion in 2025-12. Interventions recorded: Stereotactic radiosurgery/whole brain radiotherapy; Tyrosine kinase inhibitor. Conditions listed: Asymptomatic Brain Metastases; Driver Mutation Positive Non-small Cell Lung Cancer. Primary outcome: Intracranial progression free survival at 24 months. Lung eligibility wording from the registry: \"Patients with pathologically proven diagnosis of NSCLC\". Sites: India. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05236946","url":"https://clinicaltrials.gov/study/NCT05236946"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05236946","phase":"3","setting":"Observation or Upfront Cranial RT in Oncogene Driver Mutated NSCLC With Asymptomatic Brain Metastases: A Phase III Randomized Controlled Trial","sponsor":"Tata Memorial Hospital","started":"2020-11-10","startedType":"actual","enrolled":190,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00569127","kind":"trial","name":"Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor","aka":[],"tldr":"A phase 3 trial of bevacizumab (glioblastoma use) in colorectal cancer, run by National Cancer Institute (NCI), active but no longer recruiting.","summary":"Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor is a phase 3, randomised interventional study registered as NCT00569127 by National Cancer Institute (NCI), with a registry enrolment figure of 427 participants, started 2007-12-01 and due to reach its primary completion in 2015-01-01. Interventions recorded: Bevacizumab; Laboratory Biomarker Analysis; Octreotide Acetate; Recombinant Interferon Alfa-2b. Conditions listed: Colorectal Neuroendocrine Tumor G1; Gastric Neuroendocrine Tumor G1; Neuroendocrine Neoplasm; Neuroendocrine Tumor; Neuroendocrine Tumor G2. Primary outcome: Central Review-based Progression-Free Survival. Colorectal eligibility wording from the registry: \"* Metastatic colorectal carcinoid; patients with metastatic cecal or appendiceal carcinoid tumor are not eligible unless the tumors fit into one of the other high-risk categories (a, b, or c above)\". Sites: United States. Results were posted on ClinicalTrials.gov in 2016; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00569127","url":"https://clinicaltrials.gov/study/NCT00569127"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00569127","phase":"3","setting":"Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients","sponsor":"National Cancer Institute (NCI)","started":"2007-12-01","startedType":"actual","yearReported":2016,"enrolled":427,"enrolledBasis":"registry","outcomes":[{"endpoint":"Central Review-based Progression-Free Survival","primary":true,"unit":"months","arms":[{"name":"Octreotide, Bevacizumab","n":200,"value":16.6,"note":"95% CI 12.9 to 19.6; Figures from the ClinicalTrials.gov results section (first posted 2016-04-28), not from a publication"},{"name":"Octreotide, Interferon Alpha-2b","n":202,"value":15.4,"note":"95% CI 9.6 to 18.6"}],"hr":0.93,"ci":[0.73,1.18],"p":"0.55","source":"https://clinicaltrials.gov/study/NCT00569127?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"Octreotide, Bevacizumab","n":200,"value":35.2,"note":"95% CI 33.1 to 42.8; Figures from the ClinicalTrials.gov results section (first posted 2016-04-28), not from a publication"},{"name":"Octreotide, Interferon Alpha-2b","n":202,"value":47.3,"note":"95% CI 35.8 to 52.6"}],"source":"https://clinicaltrials.gov/study/NCT00569127?tab=results"}]},{"id":"nct07382531","kind":"trial","name":"OH2 Injection in Combination With BS006 Injection for Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of OH2+BS006 in advanced solid tumours, run by Binhui Biopharmaceutical Co., Ltd., now recruiting.","summary":"OH2 Injection in Combination With BS006 Injection for Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07382531 by Binhui Biopharmaceutical Co., Ltd., with 30 participants planned, started 2023-09-07 and due to reach its primary completion in 2027-12-31. Interventions recorded: OH2+BS006.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07382531","url":"https://clinicaltrials.gov/study/NCT07382531"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["binhui-biopharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07382531","phase":"1/2","setting":"An Open-label, Dose-escalation Phase Ib/II Clinical Trial of Intratumoral Injection of OH2 Injection in Combination With BS006 Injection for the Treatment of Advanced Solid Tumors.","sponsor":"Binhui Biopharmaceutical Co., Ltd.","started":"2023-09-07","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04616443","kind":"trial","name":"OH2 Injection in Combination With HX008 for Melanoma.","aka":[],"tldr":"A phase 1/2 trial of Pucotenlimab in melanoma, run by Binhui Biopharmaceutical Co., Ltd., now recruiting.","summary":"OH2 Injection in Combination With HX008 for Melanoma. is a phase 1/2 interventional study registered as NCT04616443 by Binhui Biopharmaceutical Co., Ltd., with 60 participants planned, started 2020-12-01 and due to reach its primary completion in 2025-11-30. Interventions recorded: OH2 injection, HX008 injection. Conditions listed: Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04616443","url":"https://clinicaltrials.gov/study/NCT04616443"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pucotenlimab"],"companies":["binhui-biopharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04616443","phase":"1/2","setting":"Phase Ib Study of the Combination Use of Recombinant Human GM-CSF Type II Herpes Simplex Virus (OH2) Injection (Vero Cells) and HX008 Injection in the Treatment of Melanoma","sponsor":"Binhui Biopharmaceutical Co., Ltd.","started":"2020-12-01","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05868707","kind":"trial","name":"OH2 Injection in Melanoma","aka":[],"tldr":"A phase 3 trial of OH2 in melanoma, run by Binhui Biopharmaceutical Co., Ltd., now recruiting.","summary":"OH2 Injection in Melanoma is a phase 3 interventional study registered as NCT05868707 by Binhui Biopharmaceutical Co., Ltd., with 340 participants planned, started 2023-03-08 and due to reach its primary completion in 2026-03. Interventions recorded: OH2 and Salvage chemotherapy or best supportive care.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05868707","url":"https://clinicaltrials.gov/study/NCT05868707"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["binhui-biopharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05868707","phase":"3","setting":"To Evaluate a Phase III Study of OH2 Versus Investigator-selected Salvage Chemotherapy or Best Supportive Care in Melanoma Patients Who Had Failed Standard Therapy","sponsor":"Binhui Biopharmaceutical Co., Ltd.","started":"2023-03-08","startedType":"actual","enrolled":340,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03866525","kind":"trial","name":"OH2 Oncolytic Viral Therapy in Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of OH2 injection, with or without irinotecan or HX008 in advanced solid tumours, run by Binhui Biopharmaceutical Co., Ltd., now recruiting.","summary":"OH2 Oncolytic Viral Therapy in Solid Tumors is a phase 1/2 interventional study registered as NCT03866525 by Binhui Biopharmaceutical Co., Ltd., with 300 participants planned, started 2019-04-02 and due to reach its primary completion in 2025-08-30. Interventions recorded: OH2 injection, with or without irinotecan or HX008.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03866525","url":"https://clinicaltrials.gov/study/NCT03866525"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["binhui-biopharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03866525","phase":"1/2","setting":"Phase I/II Study of OH2 Injection, an Oncolytic Type 2 Herpes Simplex Virus Expressing Granulocyte Macrophage Colony-Stimulating Factor, in Malignant Solid Tumors","sponsor":"Binhui Biopharmaceutical Co., Ltd.","started":"2019-04-02","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05705492","kind":"trial","name":"Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer","aka":["ACTO"],"tldr":"A phase 2 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by OHSU Knight Cancer Institute, now recruiting.","summary":"Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer is a phase 2, randomised interventional study registered as NCT05705492 by OHSU Knight Cancer Institute, with a registry enrolment figure of 66 participants, started 2024-07-17 and due to reach its primary completion in 2027-06-30. Interventions recorded: Olanzapine, Placebo Administration, Questionnaire Administration. Conditions listed: Advanced Malignant Solid Neoplasm, Advanced Biliary Tract Carcinoma, Advanced Esophageal Carcinoma, Metastatic Esophageal Carcinoma, Locally Advanced Colorectal Carcinoma, Locally Advanced Esophageal Carcinoma, Locally Advanced Gastric Carcinoma, Metastatic Colorectal Carcinoma (mCRC), Advanced Lung Carcinoma, Locally Advanced Hepatocellular Carcinoma. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05705492","url":"https://clinicaltrials.gov/study/NCT05705492"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05705492","phase":"2","setting":"ACTO: A Phase II, Randomized, Placebo-Controlled Study Evaluating Olanzapine in the Management of Cancer Cachexia","sponsor":"OHSU Knight Cancer Institute","started":"2024-07-17","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05522491","kind":"trial","name":"Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of olaparib in triple-negative breast cancer, run by Hebei Medical University Fourth Hospital, not yet recruiting.","summary":"Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer is a phase 2, interventional study registered as NCT05522491 by Hebei Medical University Fourth Hospital, with a registry enrolment figure of 30 participants, started 2026-09-01 and due to reach its primary completion in 2030-09-01. Interventions recorded: Olaparib. Conditions listed: Solid Tumor. Triple-negative eligibility wording from the registry: \"Histologically confirmed recurrent and metastatic TNBC patients without BRCA1/2 mutation and BRCA1 promoter methylation\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05522491","url":"https://clinicaltrials.gov/study/NCT05522491"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["olaparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05522491","phase":"2","setting":"An Open-label, Single-arm, Single-center Exploratory Clinical Study of Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer","sponsor":"Hebei Medical University Fourth Hospital","started":"2026-09-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04042831","kind":"trial","name":"Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations","aka":[],"tldr":"A phase 2 trial of olaparib in gallbladder cancer and other biliary tract cancers, run by Academic and Community Cancer Research United, active and no longer recruiting.","summary":"Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations is a phase 2 interventional study registered as NCT04042831 by Academic and Community Cancer Research United, with a registry enrolment figure of 32 participants, started 2020-06-24 and due to reach its primary completion in 2025-03-12. Interventions recorded: Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Olaparib. Conditions listed: Bile Duct Adenocarcinoma, Fanconi Anemia Complementation Group Gene Mutation, Metastatic Bile Duct Carcinoma, PTEN Gene Deletion. Sites: United States. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04042831","url":"https://clinicaltrials.gov/study/NCT04042831"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["olaparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04042831","phase":"2","setting":"A Phase II Study of Olaparib in Patients With Advanced Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations","sponsor":"Academic and Community Cancer Research United","started":"2020-06-24","startedType":"actual","yearReported":2026,"enrolled":32,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Patients Alive and Progression-free at First Scan","primary":true,"unit":"participants","arms":[{"name":"Treatment (Olaparib)","n":31,"value":23,"note":"Figures from the ClinicalTrials.gov results section (first posted 2026-05-15), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04042831?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Treatment (Olaparib)","n":31,"value":11,"note":"95% CI 8.8 to 28.8; Figures from the ClinicalTrials.gov results section (first posted 2026-05-15), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04042831?tab=results"},{"endpoint":"Progression-free Survival (PFS)","unit":"weeks","arms":[{"name":"Treatment (Olaparib)","n":31,"value":16.9,"note":"95% CI 14.0 to 24.7; Figures from the ClinicalTrials.gov results section (first posted 2026-05-15), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04042831?tab=results"}]},{"id":"nct01874353","kind":"trial","name":"Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy","aka":[],"tldr":"A phase 3 trial of Olaparib in ovarian cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy is a phase 3 interventional study registered as NCT01874353 by AstraZeneca, with 327 participants enrolled, started 2013-09-03 and due to reach its primary completion in 2016-09-19. Interventions recorded: Olaparib 300mg tablets and Placebo to match olaparib 300mg. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01874353","url":"https://clinicaltrials.gov/study/NCT01874353"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["olaparib"],"companies":["astrazeneca","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01874353","phase":"3","setting":"Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy","sponsor":"AstraZeneca","started":"2013-09-03","startedType":"actual","yearReported":2018,"enrolled":327,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)","primary":true,"unit":"months","arms":[{"name":"Olaparib 300mg Tablets (Global Cohort)","n":196,"value":19.1,"note":"95% CI 16.3 to 25.7; Figures from the ClinicalTrials.gov results section (first posted 2018-02-07), not from a publication"},{"name":"Placebo Tablets (Global Cohort)","n":99,"value":5.5,"note":"95% CI 5.2 to 5.8"},{"name":"Olaparib 300mg Tablets (China Cohort)","n":22,"value":13.8,"note":"95% CI 6.5 to 16.6"},{"name":"Placebo Tablets (China Cohort)","n":10,"value":5.5,"note":"95% CI 2.7 to NA"}],"source":"https://clinicaltrials.gov/study/NCT01874353?tab=results"}]},{"id":"nct05222971","kind":"trial","name":"Olaparib With or Without Durvalumab for DDR Gene Mutated Biliary Tract Cancer Following Platinum-based Chemotherapy","aka":["OPTIMUM"],"tldr":"A phase 2 trial of durvalumab and olaparib in gallbladder cancer and other biliary tract cancers, run by Asan Medical Center, now recruiting.","summary":"Olaparib With or Without Durvalumab for DDR Gene Mutated Biliary Tract Cancer Following Platinum-based Chemotherapy is a phase 2, randomised interventional study registered as NCT05222971 by Asan Medical Center, with a registry enrolment figure of 62 participants, started 2022-04-01 and due to reach its primary completion in 2025-12-30. Interventions recorded: Durvalumab, Olaparib. Conditions listed: Biliary Tract Cancer, DNA Damage Repair Deficiency. Gallbladder cancer is named in the registry entry: \"* Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, or gallbladder carcinoma).\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05222971","url":"https://clinicaltrials.gov/study/NCT05222971"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["durvalumab","olaparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05222971","phase":"2","setting":"Randomized Open-labeled Phase 2 Study of Maintenance Olaparib With or Without Durvalumab for DDR Gene Mutated Advanced Biliary Tract Cancer Following Platinum-based Chemotherapy","sponsor":"Asan Medical Center","started":"2022-04-01","startedType":"actual","enrolled":62,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04901741","kind":"trial","name":"Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer","aka":["OPTIMUS"],"tldr":"A phase 2 trial of pembrolizumab in pancreatic cancer, run by TME Pharma AG, not yet recruiting.","summary":"Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer is a phase 2, interventional study registered as NCT04901741 by TME Pharma AG, with a registry enrolment figure of 60 participants, started 2026-01 and due to reach its primary completion in 2028-03. Interventions recorded: Olaptesed pegol; Pembrolizumab. Conditions listed: Metastatic Pancreatic Cancer. Primary outcome: Go/no-go decision for a randomized expansion study. Pancreatic eligibility wording from the registry: \"* Patient with histologically or cytologically confirmed primary metastatic adenocarcinoma of the pancreas, who\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04901741","url":"https://clinicaltrials.gov/study/NCT04901741"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04901741","phase":"2","setting":"An Open-label Phase 2 Study of Olaptesed Pegol (NOX-A12) Combined With Pembrolizumab and Nanoliposomal Irinotecan/5-FU/Leucovorin or Gemcitabine/Nab-paclitaxel in Microsatellite-stable Metastatic Pancreatic Cancer Patients","sponsor":"TME Pharma AG","started":"2026-01","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03381274","kind":"trial","name":"Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study","aka":[],"tldr":"A phase 1/2 trial of Oleclumab and Osimertinib in non-small-cell lung cancer, run by MedImmune LLC, active and no longer recruiting.","summary":"Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study is a phase 1/2 interventional study registered as NCT03381274 by MedImmune LLC, with 43 participants enrolled, started 2018-05-08 and due to reach its primary completion in 2021-05-24. Interventions recorded: Oleclumab, Osimertinib and AZD4635. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03381274","url":"https://clinicaltrials.gov/study/NCT03381274"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["oleclumab","osimertinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03381274-j-thorac-oncol-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03381274","phase":"1/2","setting":"A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects With Previously Treated Advanced EGFRm NSCLC","sponsor":"MedImmune LLC","started":"2018-05-08","startedType":"actual","yearReported":2022,"enrolled":43,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in Part 2","primary":true,"unit":"%","arms":[{"name":"Oleclumab Dose 2 + Osimertinib Dose 1","n":21,"value":19,"note":"95% CI 5.4 to 41.9; Figures from the ClinicalTrials.gov results section (first posted 2022-07-26), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03381274?tab=results"},{"endpoint":"Overall Survival (OS) for Parts 1 and 2","unit":"months","arms":[{"name":"Oleclumab Dose 1 + Osimertinib Dose 1","n":5,"value":21.9,"note":"95% CI 1.4 to NA; Figures from the ClinicalTrials.gov results section (first posted 2022-07-26), not from a publication"},{"name":"Oleclumab Dose 2 + Osimertinib Dose 1","n":21,"value":24.8,"note":"95% CI 12.3 to NA"},{"name":"Oleclumab Dose 1 + AZD4635 Dose 1","n":6,"value":16.4,"note":"95% CI 1.0 to 16.4"},{"name":"Oleclumab Dose 1 + AZD4635 Dose 2","n":6,"value":27.4,"note":"95% CI 1.5 to NA"},{"name":"Oleclumab Dose 2 + AZD4635 Dose 2","n":5,"value":7.1,"note":"95% CI 1.9 to NA"}],"source":"https://clinicaltrials.gov/study/NCT03381274?tab=results"},{"endpoint":"Progression Free Survival (PFS) for Parts 1 and 2","unit":"months","arms":[{"name":"Oleclumab Dose 1 + Osimertinib Dose 1","n":5,"value":6.5,"note":"95% CI 1.4 to 19.8; Figures from the ClinicalTrials.gov results section (first posted 2022-07-26), not from a publication"},{"name":"Oleclumab Dose 2 + Osimertinib Dose 1","n":21,"value":11,"note":"95% CI 3.7 to NA"},{"name":"Oleclumab Dose 1 + AZD4635 Dose 1","n":6,"value":1.4,"note":"95% CI 0.5 to 1.8"},{"name":"Oleclumab Dose 1 + AZD4635 Dose 2","n":6,"value":1.8,"note":"95% CI 0.8 to 5.5"},{"name":"Oleclumab Dose 2 + AZD4635 Dose 2","n":5,"value":1.9,"note":"95% CI 1.4 to 2.3"}],"source":"https://clinicaltrials.gov/study/NCT03381274?tab=results"}]},{"id":"nct03228277","kind":"trial","name":"Olmutinib Trial in T790M (+) NSCLC Patients Detected by Liquid Biopsy Using BALF Extracellular Vesicular DNA","aka":[],"tldr":"A phase 2 trial of Olmutinib in Non-small-cell lung cancer, run by Konkuk University Medical Center, completed.","summary":"Olmutinib Trial in T790M (+) NSCLC Patients Detected by Liquid Biopsy Using BALF Extracellular Vesicular DNA is a phase 2 interventional study registered as NCT03228277 by Konkuk University Medical Center, with 25 participants recorded, started 2017-07-17 and reaching its primary completion in 2018-07-31. Interventions recorded: Olmutinib. Conditions recorded: Non Small Cell Lung Cancer.\n\nLinked to the drug Olmutinib because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03228277","url":"https://clinicaltrials.gov/study/NCT03228277"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["olmutinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03228277","phase":"2","setting":"Phase II, Multicenter, Single-arm, Open-label Study to Evaluate the Efficacy of Olmutinib(Olita®) in Patients With NSCLC Who Harboring T790M Mutation Confirmed Using DNA Extracted From Extracellular Vesicles in Bronchoalveolar Lavage Fluid","sponsor":"Konkuk University Medical Center","started":"2017-07-17","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"olympia","kind":"trial","name":"OlympiA","aka":[],"tldr":"Showed that a year of a PARP inhibitor after standard treatment improves survival in women with inherited BRCA mutations.","summary":"OlympiA, trial NCT02032823 sponsored by AstraZeneca, NRG Oncology and the Breast International Group and published in the New England Journal of Medicine in 2021, showed that a year of the PARP inhibitor olaparib after standard treatment improves survival in women with germline BRCA mutations and high-risk, HER2-negative early breast cancer, about eighty percent of whom had triple-negative disease. It randomised 1,836 patients to olaparib or placebo, met its primary invasive disease-free survival endpoint and showed an overall survival benefit that was sustained at six years. It makes germline testing a treatment decision for every such patient, and whether the benefit extends to somatic or non-BRCA HRD alterations is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT02032823","url":"https://clinicaltrials.gov/study/NCT02032823"},{"label":"OlympiA overall survival (Annals of Oncology 2022)","url":"https://doi.org/10.1016/j.annonc.2022.09.159"},{"label":"NICE TA886 (10 May 2023)","url":"https://www.nice.org.uk/guidance/ta886"},{"label":"Lynparza label (openFDA): OlympiA eligibility and results","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22LYNPARZA%22"}],"tags":[],"related":[],"cancers":["tnbc","breast-hr-positive","tnbc-early","hr-positive-early-high-risk"],"sections":[],"technologies":["parp-inhibitor"],"targets":["brca"],"drugs":["olaparib"],"companies":["nrg-oncology","big","breast-cancer-trials"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["andrew-tutt","charles-geyer","judy-garber"],"bottlenecks":[],"keyPapers":["paper-olympia-nejm-2021"],"journals":[],"dependsOn":[],"notes":["Second interim overall survival analysis (Annals of Oncology 2022, median follow-up 3.5 years): hazard ratio 0.68 (98.5 percent confidence interval 0.47 to 0.97, p 0.009), four-year overall survival 89.8 versus 86.4 percent, four-year invasive disease-free survival 82.7 versus 75.4 percent, distant disease-free survival 86.5 versus 79.1 percent; no new cases of acute myeloid leukaemia or myelodysplasia. Eligibility (Lynparza label): triple-negative patients needed residual invasive disease after neoadjuvant chemotherapy, or node-positive disease or a tumour of 2 cm or more after adjuvant chemotherapy; 82 percent of the trial was triple-negative. UK: 22 registry sites; NICE TA886 (10 May 2023) commissions the year of olaparib."],"nct":"NCT02032823","phase":"3","setting":"Adjuvant olaparib for one year in germline BRCA-mutated, HER2-negative, high-risk early breast cancer","sponsor":"AstraZeneca / NRG / BIG","result":"iDFS HR 0.58; OS HR 0.72.","started":"2014-04-22","startedType":"actual","yearReported":2021,"enrolled":1837,"enrolledBasis":"registry","outcomes":[{"endpoint":"Invasive disease-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Olaparib","n":921,"value":85.9},{"name":"Placebo","n":915,"value":77.1}],"hr":0.58,"ci":[0.41,0.82],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2105215"},{"endpoint":"Overall survival at 4 years","unit":"%","arms":[{"name":"Olaparib","value":89.8},{"name":"Placebo","value":86.4}],"hr":0.68,"ci":[0.47,0.97],"p":"0.009","source":"https://www.annalsofoncology.org/article/S0923-7534(22)04165-7/fulltext"},{"endpoint":"Overall survival at 6 years","unit":"%","arms":[{"name":"Olaparib","value":87.5},{"name":"Placebo","value":83.2}],"hr":0.72,"ci":[0.56,0.93],"source":"https://clinicaltrials.gov/study/NCT02032823"}],"replication":"Single pivotal adjuvant trial with a sustained OS benefit at 6 years; consistent with the metastatic-setting PFS benefit of olaparib (OlympiAD) and talazoparib (EMBRACA)."},{"id":"olympiad","kind":"trial","name":"OlympiAD","aka":[],"tldr":"OlympiAD was the first trial to show a PARP inhibitor tablet beats chemotherapy in breast cancer, delaying progression by about three months in women with an inherited BRCA mutation and with fewer side effects, though it did not lengthen life overall.","summary":"OlympiAD, trial NCT02000622 sponsored by AstraZeneca and published in the New England Journal of Medicine in 2017, randomised 302 patients with a germline BRCA1 or BRCA2 mutation and HER2-negative metastatic breast cancer, about half triple-negative, to olaparib tablets or the physician's choice of capecitabine, eribulin or vinorelbine. Progression-free survival rose from 4.2 to 7.0 months (hazard ratio 0.58), the response rate doubled and severe side effects were less common with olaparib; overall survival was 19.3 against 17.1 months and not significantly different, with a suggestion of benefit in patients who had not had chemotherapy for metastatic disease. It led to the January 2018 approval of olaparib, the first PARP inhibitor for breast cancer, and made germline testing a treatment decision in metastatic disease. Whether PARP inhibition should come before or after platinum, to which it shares a mechanism of resistance, is the open question.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02000622","url":"https://clinicaltrials.gov/study/NCT02000622"},{"label":"Robson et al., OlympiAD (NEJM 2017)","url":"https://doi.org/10.1056/NEJMoa1706450"},{"label":"OlympiAD final overall survival (Annals of Oncology 2019)","url":"https://doi.org/10.1093/annonc/mdz012"},{"label":"NICE TA1040 (12 February 2025)","url":"https://www.nice.org.uk/guidance/ta1040"}],"tags":[],"related":[],"cancers":["tnbc","breast-hr-positive","tnbc-metastatic","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["parp-inhibitor"],"targets":["brca","parp"],"drugs":["olaparib","capecitabine","eribulin","vinorelbine"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["gbrca-mutation"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-olympiad-nejm-2017","paper-olympiad-ann-oncol-2019-update"],"journals":[],"dependsOn":[],"notes":["Triple-negative subgroup, final overall survival (Annals of Oncology 2019): hazard ratio 0.93 (0.62 to 1.43) against 0.86 in hormone-receptor-positive disease; patients with no prior chemotherapy for metastatic disease 0.51 (0.29 to 0.90). Six UK sites (Aberdeen, Colchester, Coventry, London, Manchester, Plymouth). England: NICE TA1040 (12 February 2025) commissions olaparib for this indication."],"nct":"NCT02000622","phase":"3","setting":"Germline BRCA-mutated, HER2-negative metastatic breast cancer after up to two chemotherapy lines: olaparib vs physician's choice chemotherapy","sponsor":"AstraZeneca","result":"PFS 7.0 vs 4.2 months, HR 0.58; OS 19.3 vs 17.1 months, not significant.","started":"2014-03-27","startedType":"actual","yearReported":2017,"enrolled":302,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Olaparib","n":205,"value":7},{"name":"Chemotherapy","n":97,"value":4.2}],"hr":0.58,"ci":[0.43,0.8],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1706450"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Olaparib","value":19.3},{"name":"Chemotherapy","value":17.1}],"hr":0.9,"ci":[0.66,1.23],"source":"https://doi.org/10.1093/annonc/mdz012"}],"replication":"EMBRACA with talazoparib reached the same conclusion; neither trial showed an overall survival benefit."},{"id":"nct07008716","kind":"trial","name":"Omitting CTV for Primary Tumor in LS-SCLC","aka":[],"tldr":"A phase 3 trial of etoposide, carboplatin and cisplatin in lung cancer, run by Sun Yat-sen University, now recruiting.","summary":"Omitting CTV for Primary Tumor in LS-SCLC is a phase 3, randomised interventional study registered as NCT07008716 by Sun Yat-sen University, with a registry enrolment figure of 852 participants, started 2025-06-03 and due to reach its primary completion in 2027-12-31. Interventions recorded: Radiation Therapy; Etoposide + carboplatin; Etoposide + cisplatin; Creating CTV for primary tumor; prophylactic cranial irradiation (PCI). Conditions listed: SCLC, Limited Stage; Radiation Exposure; Radiotherapy Side Effect; Progression. Primary outcome: Local progression free survival; Severe toxicity free survival. Lung eligibility wording from the registry: \"Small cell lung cancer confirmed by histology or cytology; TNM stage IA-IIIC (AJCC 8th edition, 2017; limited-stage) without intrapulmonary metastasis;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07008716","url":"https://clinicaltrials.gov/study/NCT07008716"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["limited-stage-sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["etoposide","carboplatin","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07008716","phase":"3","setting":"Omission of Clinical Target Volume (CTV) for Primary Tumors in Limited-Stage Small Cell Lung Cancer: A Prospective Multicenter Randomized Controlled Trial","sponsor":"Sun Yat-sen University","started":"2025-06-03","startedType":"estimated","enrolled":852,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05446298","kind":"trial","name":"ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer","aka":["PRESERVE-004"],"tldr":"A phase 2 trial of Gotistobart, Pembrolizumab in ovarian cancer, run by OncoC4, Inc., active and no longer recruiting.","summary":"ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer is a phase 2 interventional study registered as NCT05446298 by OncoC4, Inc., with 58 participants enrolled, started 2022-12-22 and due to reach its primary completion in 2026-08-30. Interventions recorded: ONC-392, Pembrolizumab. Conditions listed: Ovarian Cancer, High Grade Serous Adenocarcinoma of Ovary, Primary Peritoneal Carcinoma, Fallopian Tube Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05446298","url":"https://clinicaltrials.gov/study/NCT05446298"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["gotistobart","pembrolizumab"],"companies":["oncoc4"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05446298","phase":"2","setting":"Phase 2 Randomized Open-label Multicenter Study of Combination of ONC-392 and Pembrolizumab for the Treatment of Patients With Platinum Resistant Ovarian Cancer (PROC)","sponsor":"OncoC4, Inc.","started":"2022-12-22","startedType":"actual","enrolled":58,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05682443","kind":"trial","name":"ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC","aka":["PRESERVE-006"],"tldr":"A phase 1/2 trial of Gotistobart, Lutetium-177 vipivotide tetraxetan in prostate cancer, run by OncoC4, Inc., active and no longer recruiting.","summary":"ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC is a phase 1/2 interventional study registered as NCT05682443 by OncoC4, Inc., with 148 participants enrolled, started 2023-12-11 and due to reach its primary completion in 2026-11-30. Interventions recorded: ONC-392 low, ONC-392 high, lutetium Lu 177 vipivotide tetraxetan. Conditions listed: Metastatic Castration-resistant Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05682443","url":"https://clinicaltrials.gov/study/NCT05682443"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["gotistobart","pluvicto"],"companies":["oncoc4"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05682443","phase":"1/2","setting":"Randomized Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Progressed on Androgen Receptor (AR) Pathway Inhibition","sponsor":"OncoC4, Inc.","started":"2023-12-11","startedType":"actual","enrolled":148,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05671510","kind":"trial","name":"ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors","aka":["PRESERVE-003"],"tldr":"A phase 3 trial testing Gotistobart in non-small-cell lung cancer, active and no longer recruiting.","summary":"ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors is a phase 3 interventional study registered as NCT05671510, led by OncoC4 with BioNTech SE, and active but no longer recruiting on the registry. Official title: Phase 3, Two-stage, Randomised Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors. Planned enrolment is 630 participants (estimated). The study started in 2023-06-28 and primary completion is expected in 2027-08-31. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05671510","url":"https://clinicaltrials.gov/study/NCT05671510"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["gotistobart"],"companies":["oncoc4"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05671510-nat-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05671510","phase":"3","setting":"Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors","sponsor":"OncoC4","started":"2023-06-28","startedType":"actual","enrolled":630,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05271318","kind":"trial","name":"Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a) and Pegylated Liposomal Doxorubicin (Phase 1b) ","aka":["PROTA"],"tldr":"A phase 1/2 trial of Pembrolizumab, Pegylated liposomal doxorubicin in ovarian cancer, run by TILT Biotherapeutics Ltd., active and no longer recruiting.","summary":"Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer. is a phase 1/2 interventional study registered as NCT05271318 by TILT Biotherapeutics Ltd., with 29 participants planned, started 2022-05-17 and due to reach its primary completion in 2027-03. Interventions recorded: TILT-123, pembrolizumab, pegylated liposomal doxorubicin. Conditions listed: Platinum-refractory Ovarian Carcinoma, Platinum-resistant Ovarian Cancer, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05271318","url":"https://clinicaltrials.gov/study/NCT05271318"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["pembrolizumab","pegylated-liposomal-doxorubicin","tilt-123"],"companies":["tilt-biotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05271318","phase":"1/2","setting":"A Two-part, Phase I/Ib, Open-Label, Dose-escalation Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Combination With Pembrolizumab (Phase I Part) and Pembrolizumab and Pegylated Liposomal Doxorubicin (Phase Ib Part) in Patients With Platinum Resistant or Refractory Ovarian Cancer","sponsor":"TILT Biotherapeutics Ltd.","started":"2022-05-17","startedType":"actual","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07381309","kind":"trial","name":"Oncolytic Virus (H101) + SBRT + Chemotherapy + Targeted Therapy + Immunotherapy for Unresectable CRLM","aka":["VVSHIP"],"tldr":"A phase 2 trial of fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by Jun Huang, not yet recruiting.","summary":"Oncolytic Virus (H101) + SBRT + Chemotherapy + Targeted Therapy + Immunotherapy for Unresectable CRLM is a phase 2, randomised interventional study registered as NCT07381309 by Jun Huang, with a registry enrolment figure of 114 participants, started 2026-06-01 and due to reach its primary completion in 2028-02-01. Interventions recorded: SBRT; PD-1 Antibody; H101; Target Therapy; FOLFIRI; Chemotherapy. Conditions listed: CRC; Liver Metastasis Colon Cancer. Primary outcome: ORR. Colorectal eligibility wording from the registry: \"Patients with pMMR/MSS colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07381309","url":"https://clinicaltrials.gov/study/NCT07381309"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","sbrt","topoisomerase-inhibitors"],"targets":[],"drugs":["folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07381309","phase":"2","setting":"Oncolytic Virus (H101) Peritumoral Injection Combined With SBRT, Chemotherapy, Targeted Therapy, and Immunotherapy for Unresectable MSS/pMMR Colorectal Cancer Liver Metastases (CRLM)","sponsor":"Jun Huang","started":"2026-06-01","startedType":"estimated","enrolled":114,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06919848","kind":"trial","name":"Oncolytic Virus H101 Combined With Lenvatinib Plus Toripalimab Compared With FOLFOX in Patients With Advanced Biliary Tract Cancer (OPTIONS-06)","aka":["OPTIONS-06"],"tldr":"A phase 2 trial of toripalimab, FOLFOX and lenvatinib in gallbladder cancer and other biliary tract cancers, run by Fudan University, not yet recruiting.","summary":"Oncolytic Virus H101 Combined With Lenvatinib Plus Toripalimab Compared With FOLFOX in Patients With Advanced Biliary Tract Cancer (OPTIONS-06) is a phase 2, randomised interventional study registered as NCT06919848 by Fudan University, with a registry enrolment figure of 74 participants, started 2025-05-01 and due to reach its primary completion in 2027-05-01. Interventions recorded: TORIPALIMAB INJECTION(JS001 ), Lenvatinib, H101, FOLFOX. Conditions listed: Biliary Tract Cancer (BTC). Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06919848","url":"https://clinicaltrials.gov/study/NCT06919848"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","kinase-inhibitors"],"targets":[],"drugs":["toripalimab","folfox","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06919848","phase":"2","setting":"Oncolytic Virus H101 Combined With Lenvatinib Plus Toripalimab Compared With FOLFOX in Patients With Advanced Biliary Tract Cancer (OPTIONS-06): a Multicenter, Randomized, Phase 2 Study","sponsor":"Fudan University","started":"2025-05-01","startedType":"estimated","enrolled":74,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06196671","kind":"trial","name":"Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer","aka":["PTCA199-8"],"tldr":"A phase 2 trial of h101 oncolytic adenovirus and camrelizumab in pancreatic cancer, run by Fudan University, not yet recruiting.","summary":"Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT06196671 by Fudan University, with a registry enrolment figure of 30 participants, started 2026-12-01 and due to reach its primary completion in 2028-01-01. Interventions recorded: H101; Camrelizumab. Conditions listed: Pancreatic Cancer. Primary outcome: Overall survival，OS. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed advanced pancreas adenocarcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06196671","url":"https://clinicaltrials.gov/study/NCT06196671"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["h101-oncolytic-adenovirus","camrelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06196671","phase":"2","setting":"Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer","sponsor":"Fudan University","started":"2026-12-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06904378","kind":"trial","name":"ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma","aka":[],"tldr":"A phase 1/2 trial of gemcitabine and nab-paclitaxel in pancreatic cancer, run by Washington University School of Medicine, now recruiting.","summary":"ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma is a phase 1/2, randomised interventional study registered as NCT06904378 by Washington University School of Medicine, with a registry enrolment figure of 61 participants, started 2026-03-25 and due to reach its primary completion in 2028-09-30. Interventions recorded: ONT01; Gemcitabine; Nab paclitaxel. Conditions listed: Metastatic Pancreatic Ductal Adenocarcinoma. Primary outcome: Recommended phase II dose (RP2D) (Phase I only); Number of participants with dose-limiting toxicities (DLTs) (Phase I only); Progression-free rate at 6 months (RP2D participants in Phase I and Phase II participants only). Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed adenocarcinoma of the pancreas\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06904378","url":"https://clinicaltrials.gov/study/NCT06904378"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06904378","phase":"1/2","setting":"Phase I/II Clinical Trial of ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma: Reprogramming Tumor-associated Myeloid Cells","sponsor":"Washington University School of Medicine","started":"2026-03-25","startedType":"actual","enrolled":61,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06736717","kind":"trial","name":"Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer","aka":["PANCONVA"],"tldr":"A phase 1/2 trial of onvansertib and nALIRIFOX (liposomal irinotecan + oxaliplatin + 5-FU/LV) in pancreatic cancer, run by University of Kansas Medical Center, now recruiting.","summary":"Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer is a phase 1/2, interventional study registered as NCT06736717 by University of Kansas Medical Center, with a registry enrolment figure of 21 participants, started 2025-02 and due to reach its primary completion in 2026-07. Interventions recorded: Onvansertib; NALIRIFOX. Conditions listed: Pancreatic Cancer. Primary outcome: Overall Response Rate (ORR). Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06736717","url":"https://clinicaltrials.gov/study/NCT06736717"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["onvansertib","nalirifox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06736717","phase":"1/2","setting":"A Phase 1b/2 Trial of Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer","sponsor":"University of Kansas Medical Center","started":"2025-02","startedType":"estimated","enrolled":21,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06016738","kind":"trial","name":"OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer","aka":["OPERA-01"],"tldr":"A phase 3 trial of Fulvestrant and Exemestane in HR-positive / HER2-negative breast cancer, run by Olema Pharmaceuticals, Inc., active and no longer recruiting.","summary":"OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer is a phase 3 interventional study registered as NCT06016738 by Olema Pharmaceuticals, Inc., with 510 participants enrolled, started 2023-11-16 and due to reach its primary completion in 2026-10-31. Interventions recorded: Palazestrant, Fulvestrant, Anastrozole, Letrozole and Exemestane.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06016738","url":"https://clinicaltrials.gov/study/NCT06016738"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":[],"targets":[],"drugs":["fulvestrant","exemestane"],"companies":["olema-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06016738","phase":"3","setting":"A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)","sponsor":"Olema Pharmaceuticals, Inc.","started":"2023-11-16","startedType":"actual","enrolled":510,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06369259","kind":"trial","name":"Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-R","aka":[],"tldr":"A phase 2 trial of avutometinib + defactinib and cetuximab in colorectal cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT06369259 by M.D. Anderson Cancer Center, with a registry enrolment figure of 33 participants, started 2025-02-24 and due to reach its primary completion in 2029-02-01. Interventions recorded: Defactinib; Cetuximab; Avutometinib. Conditions listed: Advanced Colorectal Cancer. Primary outcome: Safety and adverse events (AEs). Colorectal eligibility wording from the registry: \"* Histologically (or cytologically) confirmed diagnosis of adenocarcinoma of the colon or rectum, with clinical confirmation of unresectable and/or metastatic disease that is measurable according to RECIST1\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06369259","url":"https://clinicaltrials.gov/study/NCT06369259"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["avutometinib-defactinib","cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06369259","phase":"2","setting":"Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer","sponsor":"M.D. Anderson Cancer Center","started":"2025-02-24","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06780670","kind":"trial","name":"Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy","aka":["PSMAcTION"],"tldr":"A phase 2/3 trial testing AAA817 in prostate cancer, now recruiting.","summary":"Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy is a phase 2/3 interventional study registered as NCT06780670, led by Novartis Pharmaceuticals, and recruiting on the registry. Official title: PSMAcTION: A Phase II/III, Open-label, International, Multicenter, Randomised Study of AAA817 Versus Standard of Care in the Treatment of Adult Participants With PSMA Positive Metastatic Castration-resistant Prostate Cancer Who Progressed on or After [177Lu]Lu-PSMA Targeted Therapy. Planned enrolment is 443 participants (estimated). The study started in 2025-02-27 and primary completion is expected in 2028-06-27. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06780670","url":"https://clinicaltrials.gov/study/NCT06780670"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["aaa817"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06780670","phase":"2/3","setting":"PSMAcTION: A Phase II/III, Open-label, International, Multicenter, Randomized Study of AAA817 Versus Standard of Care in the Treatment of Adult Participants With PSMA Positive Metastatic Castration-resistant Prostate Cancer Who Progressed on or After [177Lu]Lu-PSMA Targeted Therapy","sponsor":"Novartis Pharmaceuticals","started":"2025-02-27","startedType":"actual","enrolled":443,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04975997","kind":"trial","name":"Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants ","aka":["EXCALIBER-RRMM"],"tldr":"A phase 3 trial of Dexamethasone, Daratumumab, Bortezomib in multiple myeloma, run by Celgene, active and no longer recruiting.","summary":"Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) is a phase 3 interventional study registered as NCT04975997 by Celgene, with 939 participants enrolled, started 2022-06-23 and due to reach its primary completion in 2027-11-16. Interventions recorded: Dexamethasone, Daratumumab, Bortezomib, Iberdomide, Iberdomide. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04975997","url":"https://clinicaltrials.gov/study/NCT04975997"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","celmods","kinase-inhibitors","monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["dexamethasone","daratumumab","bortezomib","iberdomide"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04975997","phase":"3","setting":"A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)","sponsor":"Celgene","started":"2022-06-23","startedType":"actual","enrolled":939,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04724369","kind":"trial","name":"Open-Label Study of 18F-mFBG for Imaging Neuroblastoma","aka":[],"tldr":"A phase 3 trial of 18F-MFBG in neuroblastoma, run by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC), now completed.","summary":"Open-Label Study of 18F-mFBG for Imaging Neuroblastoma is a phase 3 interventional study registered as NCT04724369 by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC), with 43 participants enrolled, started 2021-11-18 and reached its primary completion in 2026-07-30. Interventions recorded: 18F-MFBG.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04724369","url":"https://clinicaltrials.gov/study/NCT04724369"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroblastoma"],"sections":[],"technologies":["pet"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registry status on 22 September 2026: Completed (registry record last updated 17 September 2026; primary completion reached 30 July 2026)."],"nct":"NCT04724369","phase":"3","setting":"A Prospective Phase 3 Multi-center Study to Assess the Efficacy and Safety of 18F-mFBG PET Imaging in Subjects With Neuroblastoma","sponsor":"Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)","started":"2021-11-18","startedType":"actual","enrolled":43,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06514534","kind":"trial","name":"Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.","aka":[],"tldr":"A phase 2 trial of Asciminib in chronic myeloid leukaemia, run by Novartis Pharmaceuticals, now recruiting.","summary":"Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib. is a phase 2 interventional study registered as NCT06514534 by Novartis Pharmaceuticals, with 20 participants planned, started 2025-02-18 and due to reach its primary completion in 2029-02-17. Interventions recorded: ABL001/Asciminib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06514534","url":"https://clinicaltrials.gov/study/NCT06514534"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cml","cml-advanced-phase"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["asciminib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06514534","phase":"2","setting":"A Phase II, Multi-center, Prospective, Open-label Study of Asciminib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) or Accelerated Phase (CML-AP) With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.","sponsor":"Novartis Pharmaceuticals","started":"2025-02-18","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05735080","kind":"trial","name":"Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer","aka":[],"tldr":"A phase 1/2 trial of Fulvestrant, Abemaciclib in ovarian cancer and metastatic cancer, run by Incyclix Bio, now recruiting.","summary":"Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer is a phase 1/2 interventional study registered as NCT05735080 by Incyclix Bio, with 150 participants planned, started 2023-03-28 and due to reach its primary completion in 2027-07. Interventions recorded: INX-315, Fulvestrant, Abemaciclib. Conditions listed: Breast Cancer, Breast Cancer Metastatic, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05735080","url":"https://clinicaltrials.gov/study/NCT05735080"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["fulvestrant","abemaciclib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05735080","phase":"1/2","setting":"A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer","sponsor":"Incyclix Bio","started":"2023-03-28","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05563220","kind":"trial","name":"Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer","aka":["ELEVATE"],"tldr":"A phase 1/2 trial of Elacestrant, Alpelisib, Everolimus, Ribociclib, Palbociclib and Capivasertib in advanced solid tumours, run by Stemline Therapeutics, Inc., active and no longer recruiting.","summary":"Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer is a phase 1/2 interventional study registered as NCT05563220 by Stemline Therapeutics, Inc., with 435 participants enrolled, started 2023-01-24 and due to reach its primary completion in 2026-12-27. Interventions recorded: Elacestrant, Alpelisib, Everolimus, Ribociclib, Palbociclib and Capivasertib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05563220","url":"https://clinicaltrials.gov/study/NCT05563220"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["elacestrant","alpelisib","everolimus","ribociclib","palbociclib","capivasertib"],"companies":["menarini"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05563220","phase":"1/2","setting":"A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer","sponsor":"Stemline Therapeutics, Inc.","started":"2023-01-24","startedType":"actual","enrolled":435,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05491525","kind":"trial","name":"Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC","aka":["KANGUROO"],"tldr":"A phase 2/3 trial of Vibegron in childhood cancers, run by Urovant Sciences GmbH, now recruiting.","summary":"Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC is a phase 2/3 interventional study registered as NCT05491525 by Urovant Sciences GmbH, with 71 participants planned, started 2022-10-12 and due to reach its primary completion in 2030-03. Interventions recorded: Vibegron.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05491525","url":"https://clinicaltrials.gov/study/NCT05491525"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["childhood-cancers"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05491525","phase":"2/3","setting":"A Phase 2/3, Open-label, Baseline-controlled, Multicenter, Long-term Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)","sponsor":"Urovant Sciences GmbH","started":"2022-10-12","startedType":"actual","enrolled":71,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06318897","kind":"trial","name":"Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T","aka":[],"tldr":"A phase 2 trial of carboplatin, paclitaxel / nab-paclitaxel, pembrolizumab, doxorubicin and other drugs in triple-negative breast cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer is a phase 2, randomised interventional study registered as NCT06318897 by M.D. Anderson Cancer Center, with a registry enrolment figure of 28 participants, started 2024-05-29 and due to reach its primary completion in 2027-09-30. Interventions recorded: Carboplatin; Paclitaxel; Pembrolizumab; Doxorubicin; Cyclophosphamide. Conditions listed: Stage 1 cT1b-T1cN0M0; Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Participants must have histologically confirmed ER negative, PR negative and HER2-negative (TNBC) defined as ER\\<10%, PR\\<10%, and HER2 negative (per 2018 ASCO CAP guidelines)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06318897","url":"https://clinicaltrials.gov/study/NCT06318897"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","paclitaxel","pembrolizumab","doxorubicin","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06318897","phase":"2","setting":"Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer","sponsor":"M.D. Anderson Cancer Center","started":"2024-05-29","startedType":"actual","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"opra","kind":"trial","name":"OPRA","aka":[],"tldr":"OPRA showed that about half of people with rectal cancer who receive all their chemotherapy and radiotherapy before surgery can keep their rectum without any drop in the chance of cure, and that giving the chemotherapy after the radiotherapy preserves more rectums.","summary":"OPRA randomised 324 patients with MRI-staged stage II or III rectal cancer to induction FOLFOX or CAPOX followed by chemoradiation, or to chemoradiation followed by consolidation FOLFOX or CAPOX. Patients with a clinical complete or near-complete response were offered watch and wait rather than total mesorectal excision.\n\nThree-year disease-free survival was 76 percent in both arms, no different from the historical rate with chemoradiation and surgery. Three-year survival without total mesorectal excision was 41 percent with induction chemotherapy and 53 percent with consolidation chemotherapy; regrowth after watch and wait was salvaged by surgery in almost every case without loss of disease control.\n\nOPRA made organ preservation a planned outcome of rectal cancer treatment rather than a chance finding, and the consolidation sequence is now the preferred order when the goal is to avoid surgery.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02008656","url":"https://clinicaltrials.gov/study/NCT02008656"},{"label":"Journal of Clinical Oncology 2022","url":"https://doi.org/10.1200/JCO.22.00032"}],"tags":[],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["imrt-igrt","mri"],"targets":[],"drugs":["folfox","capox"],"companies":[],"institutions":["mskcc"],"pathways":[],"terms":["total-neoadjuvant-therapy","organ-preservation","clinical-complete-response","total-mesorectal-excision","chemoradiation"],"trials":["cao-aro-aio-12","iwwd","stellar-rectal"],"people":["julio-garcia-aguilar"],"bottlenecks":[],"keyPapers":["paper-garcia-aguilar-opra-organ-preservation-jco-2022","paper-opra-j-clin-oncol-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02008656","phase":"2","setting":"Stage II or III rectal adenocarcinoma: total neoadjuvant therapy as induction chemotherapy then chemoradiation, or chemoradiation then consolidation chemotherapy, with watch and wait offered to patients whose tumour disappeared","sponsor":"Memorial Sloan Kettering Cancer Center","result":"3-year disease-free survival 76% in both arms; 3-year survival without total mesorectal excision 41% (induction) vs 53% (consolidation).","started":"2013-11","startedType":"actual","yearReported":2022,"enrolled":324,"enrolledBasis":"registry","outcomes":[{"endpoint":"Survival without total mesorectal excision at 3 years","primary":true,"unit":"%","arms":[{"name":"Induction chemotherapy then chemoradiation","n":158,"value":41},{"name":"Chemoradiation then consolidation chemotherapy","n":166,"value":53}],"source":"https://doi.org/10.1200/JCO.22.00032"},{"endpoint":"Disease-free survival at 3 years","unit":"%","arms":[{"name":"Induction chemotherapy then chemoradiation","n":158,"value":76},{"name":"Chemoradiation then consolidation chemotherapy","n":166,"value":76}],"source":"https://doi.org/10.1200/JCO.22.00032"}],"replication":"Consistent with the Habr-Gama single-centre series and the International Watch and Wait Database; RAPIDO and PRODIGE 23 confirm the disease-control side of total neoadjuvant therapy."},{"id":"opt-in","kind":"trial","name":"OPT-IN (EA2197)","aka":["OPT-IN","EA2197","Optimal Perioperative Therapy for Incidental Gallbladder Cancer"],"tldr":"OPT-IN is the American trial asking whether people whose gallbladder cancer was found by chance should have chemotherapy before their second operation or only after it. It is the first randomised test of neoadjuvant treatment in incidental gallbladder cancer and will report overall survival.","summary":"OPT-IN (ECOG-ACRIN EA2197, NCT04559139) is a randomised phase 2/3 trial for patients with histologically confirmed T2 or T3 gallbladder cancer discovered incidentally at or after routine cholecystectomy for presumed benign disease, without disseminated disease. Patients are randomised to neoadjuvant gemcitabine and cisplatin followed by re-resection (partial hepatectomy of the gallbladder bed with portal lymphadenectomy) and further chemotherapy, or to immediate re-resection followed by adjuvant chemotherapy. The primary endpoint is the difference in overall survival; 186 patients are planned across 367 US sites, the trial opened in February 2021, is active but no longer recruiting, and lists primary completion in July 2028. It is the only randomised trial dedicated to incidental gallbladder cancer still running after the German GAIN trial closed early, and its result will decide whether the 4 to 8 week window before re-resection should be filled with chemotherapy.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04559139","url":"https://clinicaltrials.gov/study/NCT04559139"},{"label":"Trial in progress, Ann Surg Oncol 2022","url":"https://doi.org/10.1245/s10434-021-10277-7"}],"tags":[],"related":["gain-igbc"],"cancers":["gallbladder","incidental-gallbladder-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","gallbladder-cancer-surgery"],"targets":[],"drugs":["gemcitabine-cisplatin","gemcitabine","cisplatin"],"companies":["ecog-acrin"],"institutions":[],"pathways":[],"terms":["radical-cholecystectomy","hepatectomy","lymphadenectomy","neoadjuvant-adjuvant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-varshney-neoadjuvant-incidental-gallbladder-cancer-systematic-review-ahbps-2025"],"journals":[],"dependsOn":[],"notes":["Key facts: T2 or T3 gallbladder cancer found incidentally at or after cholecystectomy; neoadjuvant gemcitabine and cisplatin then re-resection (partial hepatectomy with lymphadenectomy) and further chemotherapy versus re-resection then adjuvant chemotherapy; primary endpoint difference in overall survival; 186 planned at 367 US sites; opened February 2021, active but not recruiting, primary completion July 2028. No UK sites."],"nct":"NCT04559139","phase":"2/3","setting":"Incidental T2 or T3 gallbladder cancer found at or after cholecystectomy: gemcitabine and cisplatin before and after re-resection (partial hepatectomy with lymphadenectomy) versus re-resection followed by chemotherapy alone","sponsor":"ECOG-ACRIN Cancer Research Group","started":"2021-02-24","startedType":"actual","enrolled":186,"enrolledBasis":"registry","outcomes":[]},{"id":"optimice-pcr","kind":"trial","name":"OptimICE-pCR (A012103)","aka":[],"tldr":"Asks whether patients whose cancer completely disappeared before surgery still need a year of immunotherapy afterwards.","summary":"OptimICE-pCR, Alliance trial A012103, NCT05812807, sponsored by the Alliance and the NCI, asks whether patients with stage II to III triple-negative breast cancer whose cancer completely disappeared before surgery on the KEYNOTE-522 regimen still need a year of adjuvant pembrolizumab afterwards. It is a de-escalation trial of 1,295 patients comparing adjuvant pembrolizumab with observation, and if non-inferior it would spare about sixty percent of KEYNOTE-522 patients nine cycles of immunotherapy; it was discussed at ASCO 2026 and is ongoing with no results. OnCo links it to triple-negative breast cancer, pembrolizumab, the pCR term, the TNBC roadmap, the idea of ctDNA-triggered escalation and the Alliance for Clinical Trials in Oncology. Whether pathologic complete response is a safe enough signal to stop treatment is the question it will answer.","status":"recruiting","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05812807","url":"https://clinicaltrials.gov/study/NCT05812807"}],"tags":[],"related":[],"cancers":["tnbc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":["pcr"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05812807","phase":"3","setting":"Stage II-III TNBC with pathologic complete response after KEYNOTE-522 regimen: adjuvant pembrolizumab vs observation","sponsor":"Alliance / NCI","started":"2023-06-14","startedType":"actual","enrolled":1295,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing de-escalation trial; no results."},{"id":"nct07527806","kind":"trial","name":"Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging","aka":[],"tldr":"A phase 2 trial of HER2 PET in Breast cancer, run by Peking University Cancer Hospital & Institute, not yet recruiting.","summary":"Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging is a phase 2 interventional study registered as NCT07527806 by Peking University Cancer Hospital & Institute, with 156 participants planned, started 2026-05-01 and due to reach its primary completion in 2029-05-01. Interventions recorded: Trastuzumab (Herceptin), Pertuzumab, Combination product: Trastuzumab + Pertuzumab, Docetaxel or Nab-paclitaxel, carboplatin, CDK4/6 inhibitor, Aromatase Inhibitor (AI), ADC. Conditions recorded: Breast Cancer.\n\nLinked to the technology HER2 PET because the registry's title names it (\"her2 pet\") and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07527806","url":"https://clinicaltrials.gov/study/NCT07527806"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["her2-pet"],"targets":[],"drugs":["trastuzumab","pertuzumab","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07527806","phase":"2","setting":"A Prospective, Double-Arm Study on the Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging","sponsor":"Peking University Cancer Hospital & Institute","started":"2026-05-01","startedType":"estimated","enrolled":156,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04680260","kind":"trial","name":"OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer","aka":["OPTIMISE"],"tldr":"A phase 2 trial in colorectal cancer, run by Karen-Lise Garm Spindler, now recruiting.","summary":"OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT04680260 by Karen-Lise Garm Spindler, with a registry enrolment figure of 350 participants, started 2021-10-25 and due to reach its primary completion in 2027-03-01. Interventions recorded: Standard of care; Circulating tumor DNA guided treatment approach. Conditions listed: Colorectal Cancer; Metastatic Cancer. Primary outcome: Recurrence Free Rate. Sites: Denmark. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04680260","url":"https://clinicaltrials.gov/study/NCT04680260"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04680260","phase":"2","setting":"OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer - a ctDNA Guided Phase II Randomized Approach","sponsor":"Karen-Lise Garm Spindler","started":"2021-10-25","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07040098","kind":"trial","name":"Optimizing Immunotherapy Combined With Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer","aka":["STELLARIII"],"tldr":"A phase 2 trial of sintilimab and cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"Optimizing Immunotherapy Combined With Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT07040098 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 228 participants, started 2025-06-01 and due to reach its primary completion in 2027-06-30. Interventions recorded: Sintilimab; Short-course radiotherapy; Long-course concurrent chemoradiotherapy; CAPOX. Conditions listed: Locally Advanced Rectal Cancer (LARC). Primary outcome: Rate of complete response. Colorectal eligibility wording from the registry: \"Pathologically confirmed rectal adenocarcinoma with immunohistochemical results indicating pMMR (proficient mismatch repair) or genetic testing confirming MSS (microsatellite stability);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07040098","url":"https://clinicaltrials.gov/study/NCT07040098"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["sintilimab","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07040098","phase":"2","setting":"A Prospective, Multicenter, Randomized Clinical Trial of Optimizing Immunotherapy Combined With Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer (STELLARIII)","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2025-06-01","startedType":"actual","enrolled":228,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06558214","kind":"trial","name":"OPTIMUS PRIME: Safety and Feasibility of OPTune GIO® Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa, A randomizEd Trial","aka":["OPTIMUS PRIME"],"tldr":"A phase 2 trial of Laser interstitial thermal therapy systems in Glioma & glioblastoma, run by University of Florida, now recruiting.","summary":"OPTIMUS PRIME: Safety and Feasibility of OPTune GIO® Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa, A randomizEd Trial is a phase 2 interventional study registered as NCT06558214 by University of Florida, with 20 participants planned, started 2024-12-10 and due to reach its primary completion in 2029-10. Interventions recorded: Pembrolizumab, Optune GIO®, NeuroBlate®. Conditions recorded: Recurrent Glioblastoma.\n\nLinked to the technology Laser interstitial thermal therapy systems because the registry names it (\"neuroblate\") among its interventions and Glioma & glioblastoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06558214","url":"https://clinicaltrials.gov/study/NCT06558214"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["litt-systems"],"targets":[],"drugs":["pembrolizumab","optune"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06558214","phase":"2","setting":"OPTIMUS PRIME: Safety and Feasibility of OPTune GIO® Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa, A randomizEd Trial","sponsor":"University of Florida","started":"2024-12-10","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"opus","kind":"trial","name":"OPUS","aka":[],"tldr":"The oxaliplatin companion to CRYSTAL. It confirmed that the EGFR antibody only works when KRAS is normal.","summary":"OPUS randomised 344 patients with EGFR-expressing metastatic colorectal cancer to FOLFOX4 with or without cetuximab. KRAS status was evaluable in 315 of them (93 percent) and 179 (57 percent) were wild-type; 11 of 309 KRAS and BRAF evaluable tumours carried a BRAF mutation, all in the KRAS wild-type group. In KRAS wild-type disease cetuximab improved progression-free survival (hazard ratio 0.567, p=0.0064) and response (odds ratio 2.551, p=0.0027). The trial was too small to judge BRAF. Together with CRYSTAL it made KRAS testing compulsory in 2008 and 2009, the first negative predictive biomarker in solid-tumour oncology.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00125034","url":"https://clinicaltrials.gov/study/NCT00125034"},{"label":"OPUS: efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment (Annals of Oncology 2011)","url":"https://doi.org/10.1093/annonc/mdq632"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["monoclonal-antibody","cytotoxic-chemotherapy"],"targets":["egfr","kras","braf"],"drugs":["cetuximab","folfox","oxaliplatin"],"companies":["merck-kgaa"],"institutions":[],"pathways":[],"terms":[],"trials":["crystal-fire3","prime"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00125034","phase":"2","setting":"First-line EGFR-expressing metastatic colorectal cancer: FOLFOX4 with or without cetuximab, analysed by KRAS and BRAF status","sponsor":"Merck KGaA","result":"In KRAS wild-type disease, progression-free survival hazard ratio 0.567 and response odds ratio 2.551 with cetuximab added.","started":"2005-07","yearReported":2011,"enrolled":344,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (KRAS wild-type)","primary":true,"unit":"hazard ratio","arms":[{"name":"FOLFOX4 plus cetuximab","value":0.567},{"name":"FOLFOX4","value":1}],"hr":0.567,"p":"0.0064","source":"https://doi.org/10.1093/annonc/mdq632"}]},{"id":"nct05438420","kind":"trial","name":"Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in cervical cancer, run by Qurient Co., Ltd., active and no longer recruiting.","summary":"Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05438420 by Qurient Co., Ltd., with 120 participants planned, started 2023-01-12 and due to reach its primary completion in 2027-12-30. Interventions recorded: Q702, Pembrolizumab. Conditions listed: Esophageal Cancer, Gastric Cancer, Hepatocellular Cancer, Cervical Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05438420","url":"https://clinicaltrials.gov/study/NCT05438420"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["qurient"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05438420","phase":"1/2","setting":"A Phase 1B/2, Open-label Study of Q702 in Combination With Intravenous Pembrolizumab in Patients With Selected Advanced Solid Tumors","sponsor":"Qurient Co., Ltd.","started":"2023-01-12","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06764680","kind":"trial","name":"Oral Chemotherapy, Targeted Therapy and Immunotherapy With/Without Radiotherapy as 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of bevacizumab (glioblastoma use) in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Oral Chemotherapy, Targeted Therapy and Immunotherapy With/Without Radiotherapy as 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer is a phase 2, interventional study registered as NCT06764680 by Sun Yat-sen University, with a registry enrolment figure of 57 participants, started 2024-12-31 and due to reach its primary completion in 2026-06-30. Interventions recorded: Trifluorouracil tepidopyrimidine; Bevacizumab; Sindilizumab; IMRT. Conditions listed: Colorectal Cancer Metastatic; Chemotherapy; Targeted Therapy; Immunotherapy; Radiotherapy, Intensity-Modulated. Primary outcome: Objective response rate (ORR). Colorectal eligibility wording from the registry: \"patients with advanced colorectal adenocarcinoma of MSS/pMMR confirmed by histologic or cytologic diagnosis;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06764680","url":"https://clinicaltrials.gov/study/NCT06764680"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06764680","phase":"2","setting":"Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab With/Without Involved Lesions Irradiation as 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer: a Phase 2, Double Cohort Clinical Trial","sponsor":"Sun Yat-sen University","started":"2024-12-31","startedType":"actual","enrolled":57,"enrolledBasis":"registry","outcomes":[]},{"id":"metronomic-vs-cisplatin-tmh","kind":"trial","name":"Oral metronomic chemotherapy vs intravenous cisplatin (Tata Memorial)","aka":[],"tldr":"Two cheap tablets taken at home matched, and in fact beat, intravenous cisplatin for advanced head and neck cancer in a 422-patient Indian trial, with fewer side effects.","summary":"An open-label non-inferiority phase 3 randomised 422 patients (213 oral metronomic, 209 cisplatin). Median overall survival was 7.5 months with oral metronomic chemotherapy versus 6.1 months with cisplatin (hazard ratio 0.773; 95% CI 0.615-0.97; P=0.026), meeting non-inferiority and favouring the oral regimen, with grade 3 or worse adverse events in 19% versus 30%. The authors noted that NCCN-recommended options apply to fewer than 3% of patients in low- and middle-income settings because of cost. The regimen became the backbone for the later low-dose nivolumab trial and for METRO PLUS.","status":"positive","asOf":"2026-09-10","links":[{"label":"Patil et al., Lancet Global Health 2020","url":"https://doi.org/10.1016/S2214-109X(20)30275-8"}],"tags":[],"related":[],"cancers":["head-and-neck","oral-cavity-cancer","recurrent-metastatic-hnscc","buccal-mucosa-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["methotrexate","cisplatin","celecoxib"],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":[],"trials":[],"people":["patil-vijay","prabhash-kumar","noronha-vanita"],"bottlenecks":["b-generic-repurposing","b-drug-pricing","b-global-access"],"keyPapers":["paper-patil-lancet-glob-health"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Recurrent, metastatic or inoperable head and neck carcinoma, palliative intent: oral methotrexate 15 mg/m2 weekly plus celecoxib 200 mg twice daily vs intravenous cisplatin","sponsor":"Tata Memorial Centre","result":"Median OS 7.5 vs 6.1 months, HR 0.773; grade 3+ adverse events 19% vs 30%.","yearReported":2020,"enrolled":422,"enrolledBasis":"registry","outcomes":[{"endpoint":"Median overall survival","primary":true,"unit":"months","arms":[{"name":"Oral metronomic (methotrexate + celecoxib)","n":213,"value":7.5},{"name":"IV cisplatin","n":209,"value":6.1}],"hr":0.773,"ci":[0.615,0.97],"p":"0.026","source":"https://doi.org/10.1016/S2214-109X(20)30275-8"}]},{"id":"nct03315364","kind":"trial","name":"Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy","aka":["OPTIMAL"],"tldr":"A phase 2/3 trial of Oral paclitaxel in advanced solid tumours, run by Daehwa Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy is a phase 2/3 interventional study registered as NCT03315364 by Daehwa Pharmaceutical Co., Ltd., with 549 participants enrolled, started 2017-12-18 and due to reach its primary completion in 2024-02-19. Interventions recorded: Oral paclitaxel and Paclitaxel injection.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03315364","url":"https://clinicaltrials.gov/study/NCT03315364"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["daehwa-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03315364","phase":"2/3","setting":"A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Liporaxel® (Oral Paclitaxel) Compared to Taxol® (IV Paclitaxel) as First-line Therapy in Patients With Recurrent or Metastatic HER2 Negative Breast Cancer","sponsor":"Daehwa Pharmaceutical Co., Ltd.","started":"2017-12-18","startedType":"actual","enrolled":549,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07001618","kind":"trial","name":"Oral Pooled Fecal Microbiotherapy (MaaT033) Concomitant to Cemiplimab Versus Best Investigator's Choice in Patients With Resistance to Treatment Due to Antibiot","aka":["IMMUNOLIFE2"],"tldr":"A phase 2 trial of cemiplimab, cisplatin, pemetrexed, bevacizumab and other drugs in lung cancer, run by Gustave Roussy, Cancer Campus, Grand Paris, now recruiting.","summary":"Oral Pooled Fecal Microbiotherapy (MaaT033) Concomitant to Cemiplimab Versus Best Investigator's Choice in Patients With Resistance to Treatment Due to Antibiotics Uptake With Advanced Non-small Cell Lung Cancer is a phase 2, randomised interventional study registered as NCT07001618 by Gustave Roussy, Cancer Campus, Grand Paris, with a registry enrolment figure of 162 participants, started 2025-11-17 and due to reach its primary completion in 2030-09. Interventions recorded: MaaT033 capsule; Cemiplimab; Cisplatin; Carboplatine; Pemetrexed (Alimta); Bevacizumab; Paclitaxel; gemcitabine; Docetaxel; Vinorelbine i.v. 25 mg/m²; Vinorelbine oral. Conditions listed: NSCLC (Advanced Non-small Cell Lung Cancer). Primary outcome: Disease Control Rate (DCR). Lung eligibility wording from the registry: \"Histologically confirmed diagnosis of NSCLC (adenocarcinoma versus squamous cell carcinoma versus others)\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07001618","url":"https://clinicaltrials.gov/study/NCT07001618"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["cemiplimab","cisplatin","pemetrexed","bevacizumab","paclitaxel","gemcitabine","docetaxel"],"companies":["maat-pharma","regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07001618","phase":"2","setting":"A Randomized Multicenter Phase II Trial Evaluating Oral Pooled Fecal Microbiotherapy (MaaT033) Concomitant to Cemiplimab (CB) Versus Best Investigator's Choice (BIC) in Resistance to PD-1/PD-L1 Blockade Due to Antibiotics (ATB) Uptake in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","started":"2025-11-17","startedType":"actual","enrolled":162,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07581314","kind":"trial","name":"Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)","aka":[],"tldr":"A phase 1/2 trial in triple-negative breast cancer, run by Telomir Pharmaceuticals, Inc., not yet recruiting.","summary":"Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC) is a phase 1/2, interventional study registered as NCT07581314 by Telomir Pharmaceuticals, Inc., with a registry enrolment figure of 76 participants, started 2026-10 and due to reach its primary completion in 2027-05. Interventions recorded: Zn-Telomir. Conditions listed: Triple-Negative Breast Cancer (TNBC); Advanced Triple-Negative Breast Cancer; Metastatic Triple-negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Clinically defined histologically or cytologically confirmed triple-negative breast cancer (TNBC)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07581314","url":"https://clinicaltrials.gov/study/NCT07581314"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07581314","phase":"1/2","setting":"A First-in-Human (FIH), Phase I/II, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Antitumor Activity of Zn-Telomir Administered Orally as Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)","sponsor":"Telomir Pharmaceuticals, Inc.","started":"2026-10","startedType":"estimated","enrolled":76,"enrolledBasis":"registry","outcomes":[]},{"id":"orator","kind":"trial","name":"ORATOR","aka":[],"tldr":"ORATOR was the first randomised comparison of surgery and radiotherapy for early throat cancer; swallowing scores a year later were slightly better after radiotherapy, but the difference was smaller than patients would notice, so both remain reasonable choices.","summary":"Transoral robotic surgery had spread rapidly for early oropharyngeal cancer on the assumption that it spares swallowing function compared with radiotherapy, without randomised evidence. The Canadian ORATOR trial randomised 68 patients with T1 to T2, N0 to N2 oropharyngeal squamous cell carcinoma, most of them HPV-positive, to radiotherapy (70 Gy, with concurrent cisplatin for node-positive disease) or to transoral robotic surgery with neck dissection and risk-adapted adjuvant therapy. The primary endpoint was the MD Anderson Dysphagia Inventory score at one year.\n\nSwallowing quality of life was statistically better after radiotherapy but the difference fell short of the threshold regarded as clinically meaningful, and the toxicity profiles differed (more bleeding and pain with surgery, more hearing loss and mucositis with radiotherapy). Oncological outcomes were similar and good. The follow-on ORATOR2 trial compared de-intensified versions of both approaches.","status":"mixed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01590355","url":"https://clinicaltrials.gov/study/NCT01590355"}],"tags":["subtype-trials"],"related":[],"cancers":["hpv-positive-oropharyngeal-cancer","oropharyngeal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["anthony-nichols"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01590355","phase":"2","setting":"Early-stage (T1 to T2, N0 to N2) oropharyngeal squamous cell carcinoma: primary radiotherapy (with chemotherapy for node-positive disease) against transoral robotic surgery with neck dissection, with swallowing quality of life at one year as the primary endpoint","sponsor":"London Health Sciences Centre and Lawson Research Institute","result":"Swallowing quality of life at one year was statistically but not clinically meaningfully better after radiotherapy than after transoral robotic surgery; oncological outcomes were similar.","started":"2012-06","yearReported":2019,"enrolled":68,"enrolledBasis":"registry","outcomes":[{"endpoint":"MD Anderson Dysphagia Inventory total score at 1 year (mean)","primary":true,"unit":"points","arms":[{"name":"Radiotherapy (70 Gy, with chemotherapy if N1-2)","n":34,"value":86.9,"note":"Trial powered for a 10-point, clinically meaningful difference"},{"name":"Transoral robotic surgery + neck dissection","n":34,"value":80.1}],"p":"0.042","source":"https://doi.org/10.1016/s1470-2045(19)30410-3"},{"endpoint":"Neutropenia","unit":"%","arms":[{"name":"Radiotherapy (70 Gy, with chemotherapy if N1-2)","n":34,"value":18},{"name":"Transoral robotic surgery + neck dissection","n":34,"value":0}],"source":"https://doi.org/10.1016/s1470-2045(19)30410-3"},{"endpoint":"Hearing loss","unit":"%","arms":[{"name":"Radiotherapy (70 Gy, with chemotherapy if N1-2)","n":34,"value":38},{"name":"Transoral robotic surgery + neck dissection","n":34,"value":15}],"source":"https://doi.org/10.1016/s1470-2045(19)30410-3"},{"endpoint":"Trismus","unit":"%","arms":[{"name":"Radiotherapy (70 Gy, with chemotherapy if N1-2)","n":34,"value":3},{"name":"Transoral robotic surgery + neck dissection","n":34,"value":26}],"source":"https://doi.org/10.1016/s1470-2045(19)30410-3"}]},{"id":"nct04938583","kind":"trial","name":"Oregovomab in Combination With Bevacizumab Plus Chemo in BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer","aka":[],"tldr":"A phase 1/2 trial of Oregovomab, Bevacizumab, Paclitaxel / nab-paclitaxel in ovarian cancer, run by CanariaBio Inc., active and no longer recruiting.","summary":"Oregovomab in Combination With Bevacizumab Plus Chemo in BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer is a phase 1/2 interventional study registered as NCT04938583 by CanariaBio Inc., with 54 participants planned, started 2021-03-17 and due to reach its primary completion in 2025-10-30. Interventions recorded: Oregovomab, Bevacizumab, Paclitaxel, Carboplatin. Conditions listed: Ovarian Cancer by FIGO Stage, Ovarian Cancer Stage III, Ovarian Cancer Stage IV. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04938583","url":"https://clinicaltrials.gov/study/NCT04938583"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["oregovomab","bevacizumab","paclitaxel","carboplatin"],"companies":["canariabio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04938583","phase":"1/2","setting":"Phase 1b/2, Single Arm Clinical Trial to Evaluate the Safety and Activity of Oregovomab and Bevacizumab, Paclitaxel Carboplatin as a Combinatorial Strategy in Subjects With BRCA-wild Type Platinum Sensitive Recurrent Ovarian Cancer","sponsor":"CanariaBio Inc.","started":"2021-03-17","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04498117","kind":"trial","name":"Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery","aka":["FLORA-5"],"tldr":"A phase 3 trial testing Oregovomab in ovarian cancer, active and no longer recruiting.","summary":"Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery is a phase 3 interventional study registered as NCT04498117, led by CanariaBio with Gynecologic Oncology and IQVIA Pty, and active but no longer recruiting on the registry. Official title: A Multicenter Phase 3, Double-Blind, Placebo-Controlled Study Comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin- Oregovomab) vs Chemotherapy (Paclitaxel-Carboplatin- Placebo) in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma. Planned enrolment is 615 participants (actual). The study started in 2020-08-25 and primary completion is expected in 2026-12-26. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04498117","url":"https://clinicaltrials.gov/study/NCT04498117"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["oregovomab"],"companies":["canariabio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04498117","phase":"3","setting":"A Multicenter Phase 3, Double-Blind, Placebo-Controlled Study Comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin- Oregovomab) vs Chemotherapy (Paclitaxel-Carboplatin- Placebo) in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma","sponsor":"CanariaBio","started":"2020-08-25","startedType":"actual","enrolled":615,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05605535","kind":"trial","name":"Oregovomab Plus Chemotherapy in Neo-adjuvant Setting in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer","aka":[],"tldr":"A phase 2 trial of Oregovomab, Paclitaxel / nab-paclitaxel, Carboplatin in ovarian cancer, run by CanariaBio Inc., active and no longer recruiting.","summary":"Oregovomab Plus Chemotherapy in Neo-adjuvant Setting in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer is a phase 2 interventional study registered as NCT05605535 by CanariaBio Inc., with 88 participants planned, started 2023-02-07 and due to reach its primary completion in 2026-10-15. Interventions recorded: Oregovomab, Paclitaxel, Carboplatin, Placebo. Conditions listed: Ovarian Neoplasm Epithelial, Ovarian Cancer, Fallopian Tube Neoplasms, Peritoneal Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05605535","url":"https://clinicaltrials.gov/study/NCT05605535"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["oregovomab","paclitaxel","carboplatin"],"companies":["canariabio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05605535","phase":"2","setting":"A Phase 2, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial Comparing Chemoimmunotherapy (Paclitaxel-Carboplatin-Oregovomab) Versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) as Neoadjuvant Therapy in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma","sponsor":"CanariaBio Inc.","started":"2023-02-07","startedType":"actual","enrolled":88,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05969847","kind":"trial","name":"Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer","aka":["TRACE-LE"],"tldr":"A phase 2 trial of cAPOX (capecitabine, oxaliplatin) and envafolimab in colorectal cancer, run by 池畔, not yet recruiting.","summary":"Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer is a phase 2, interventional study registered as NCT05969847 by 池畔, with a registry enrolment figure of 72 participants, started 2023-08-15 and due to reach its primary completion in 2027-12-31. Interventions recorded: split-course hypofraction radiotherapy; CAPOX; Envafolimab; Local excision. Conditions listed: Rectal Cancer. Primary outcome: Organ preservation. Colorectal eligibility wording from the registry: \"Histopathology confirmed the rectal adenocarcinoma,cT3-4N0 or cT1-4N1-2\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05969847","url":"https://clinicaltrials.gov/study/NCT05969847"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capox","envafolimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05969847","phase":"2","setting":"Total Neoadjuvant Therapy With Split-course Hypofraction Radiotherapy Combined With CAPOX and Envafolimab Followed by Local Excision for Locally Advanced Very Low Rectal Cancer: an Open-label, Single-arm, Multi-center, Phase II Trial","sponsor":"池畔","started":"2023-08-15","startedType":"estimated","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06991465","kind":"trial","name":"Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA)","aka":["Hypo-OPRA"],"tldr":"A phase 2 trial of capecitabine in colorectal cancer, run by Neil Kopek, now recruiting.","summary":"Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA) is a phase 2, interventional study registered as NCT06991465 by Neil Kopek, with a registry enrolment figure of 35 participants, started 2023-08-16 and due to reach its primary completion in 2027-09. Interventions recorded: Radiation Therapy; FOLFOX regimen; Capecitabine. Conditions listed: Colorectal Carcinoma. Primary outcome: Feasibility of Hypo-fractionated Approach in 5 fractions for a dose of 35Gy. Colorectal eligibility wording from the registry: \"* Histologically confirmed invasive adenocarcinoma of the rectum\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06991465","url":"https://clinicaltrials.gov/study/NCT06991465"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06991465","phase":"2","setting":"Organ Preservation in Rectal Adenocarcinoma Using Hypofractionated Pelvic Radiotherapy (Hypo-OPRA): A Phase II Clinical Trial","sponsor":"Neil Kopek","started":"2023-08-16","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07337876","kind":"trial","name":"Organ Preservation in Rectal Cancer by Dose Escalated MR Guided Adaptive Radiotherapy","aka":[],"tldr":"A phase 2 trial of MR-guided adaptive radiotherapy in Rectal cancer, run by University Hospital Tuebingen, now recruiting.","summary":"Organ Preservation in Rectal Cancer by Dose Escalated MR Guided Adaptive Radiotherapy is a phase 2 interventional study registered as NCT07337876 by University Hospital Tuebingen, with 100 participants planned, started 2026-01-07 and due to reach its primary completion in 2029-01. Interventions recorded: Dose escalated radiotherapy using a 1.5 T MR-Linac. Conditions recorded: Rectal Cancer.\n\nLinked to the technology MR-guided adaptive radiotherapy because the registry's title names it (\"mr guided adaptive radiotherapy\") and Rectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07337876","url":"https://clinicaltrials.gov/study/NCT07337876"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["mr-linac"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07337876","phase":"2","setting":"Organ Preservation in Rectal Cancer by Dose Escalated MR Guided Adaptive Radiotherapy","sponsor":"University Hospital Tuebingen","started":"2026-01-07","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05563922","kind":"trial","name":"Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma","aka":["OP-TNT"],"tldr":"A phase 2 trial in colorectal cancer, run by Shanghai Zhongshan Hospital, now recruiting.","summary":"Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma is a phase 2, interventional study registered as NCT05563922 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 56 participants, started 2022-09-01 and due to reach its primary completion in 2025-08-31. Interventions recorded: Total Neoadjuvant Chemoradiotherapy. Conditions listed: Rectal Cancer. Primary outcome: Organ preservation rate at 3 years. Colorectal eligibility wording from the registry: \"* cT1-3N0M0 assessed by CT, MRI and ultrasound colonoscopy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05563922","url":"https://clinicaltrials.gov/study/NCT05563922"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05563922","phase":"2","setting":"Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Early Low Rectal Carcinoma: A Prospective, Exploratory Trial","sponsor":"Shanghai Zhongshan Hospital","started":"2022-09-01","startedType":"actual","enrolled":56,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06390982","kind":"trial","name":"Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study","aka":["RELIEVE-01"],"tldr":"A phase 2 trial of tislelizumab, capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study is a phase 2, interventional study registered as NCT06390982 by Fudan University, with a registry enrolment figure of 46 participants, started 2024-05 and due to reach its primary completion in 2025-12. Interventions recorded: Radiotherapy; Tislelizumab; Capecitabine; Oxaliplatin; Capecitabine. Conditions listed: RECTAL NEOPLASMS; Rectal Cancer. Primary outcome: Complete Response rate (CR rate). Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06390982","url":"https://clinicaltrials.gov/study/NCT06390982"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["tislelizumab","capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06390982","phase":"2","setting":"A Single-arm, Multicenter, Phase II Clinical Study of Chemoradiotherapy Followed by Tislelizumab Combined With Chemotherapy for Organ Preservation in Resectable Low Rectal Cancer：the RELIEVE-01 Study","sponsor":"Fudan University","started":"2024-05","startedType":"estimated","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07106528","kind":"trial","name":"Organoid-guided vs Topotecan Therapy in Relapsed Extensive-Stage Small Cell Lung Cancer","aka":[],"tldr":"A phase 2/3 trial of topotecan in lung cancer, run by Peking Union Medical College Hospital, not yet recruiting.","summary":"Organoid-guided vs Topotecan Therapy in Relapsed Extensive-Stage Small Cell Lung Cancer is a phase 2/3, randomised interventional study registered as NCT07106528 by Peking Union Medical College Hospital, with a registry enrolment figure of 128 participants, started 2025-08 and due to reach its primary completion in 2027-12. Interventions recorded: Organoid Drug Sensitivity Testing-Guided Therapy; Topotecan. Conditions listed: Extensive-stage Small Cell Lung Cancer (ES-SCLC); Extensive-stage Small Cell Lung Cancer (SCLC); Small Cell Lung Cancer ( SCLC ). Primary outcome: Progression-Free Survival (PFS). Lung eligibility wording from the registry: \"Pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (AJCC 9th edition, Stage IV)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07106528","url":"https://clinicaltrials.gov/study/NCT07106528"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["topotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07106528","phase":"2/3","setting":"Organoid-Based Drug Sensitivity Model Guided Personalized Precision Treatment for Extensive-Stage Small Cell Lung Cancer: A Prospective, Multicenter, Randomized Controlled Trial","sponsor":"Peking Union Medical College Hospital","started":"2025-08","startedType":"estimated","enrolled":128,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05652920","kind":"trial","name":"Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC","aka":["BEACON"],"tldr":"A phase 1/2 trial of Ori-C101 in hepatocellular carcinoma, run by OriCell Therapeutics Co., Ltd., now recruiting.","summary":"Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC is a phase 1/2 interventional study registered as NCT05652920 by OriCell Therapeutics Co., Ltd., with 105 participants planned, started 2022-12-15 and due to reach its primary completion in 2026-12. Interventions recorded: Ori-C101.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05652920","url":"https://clinicaltrials.gov/study/NCT05652920"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05652920","phase":"1/2","setting":"A Phase Ib/II, Open-Label, Multi-Center Study to Investigate the Safety, PK, and Efficacy of Ori-C101 in Advanced Hepatocellular Carcinoma (HCC) Patients (BEACON)","sponsor":"OriCell Therapeutics Co., Ltd.","started":"2022-12-15","startedType":"actual","enrolled":105,"enrolledBasis":"registry","outcomes":[]},{"id":"orient-11","kind":"trial","name":"ORIENT-11","aka":[],"tldr":"The trial that made sintilimab a first-line lung cancer treatment in China, and the one the FDA later refused to accept as evidence for US patients.","summary":"397 patients randomised 2:1. Median progression-free survival 8.9 versus 5.0 months (hazard ratio 0.482) at the interim analysis, with benefit across PD-L1 subgroups; overall survival later favoured sintilimab. NMPA approval followed in February 2021. Innovent and Lilly filed the same data with the FDA; at a February 2022 advisory committee members voted 14 to 1 that a single-country trial with a chemotherapy-alone comparator did not show applicability to US patients, and a complete response letter followed in March 2022, setting the template for how China-only trials are judged.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03607539","url":"https://clinicaltrials.gov/study/NCT03607539"},{"label":"J Thorac Oncol 2020","url":"https://doi.org/10.1016/j.jtho.2020.07.014"},{"label":"FDA ODAC 10 February 2022 (archived copy)","url":"https://web.archive.org/web/20250302091714/https://www.fda.gov/advisory-committees/advisory-committee-calendar/february-10-2022-meeting-oncologic-drugs-advisory-committee-meeting-announcement-02102022"}],"tags":["china"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sintilimab","pemetrexed"],"companies":["innovent"],"institutions":["nmpa-cde","fda-oce"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-orient-11-j-thorac-oncol-2020","paper-orient-11-lung-cancer-2022-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03607539","phase":"3","setting":"First-line non-squamous NSCLC without EGFR or ALK alterations, China: sintilimab or placebo plus pemetrexed and platinum","sponsor":"Innovent Biologics","result":"PFS 8.9 vs 5.0 months, HR 0.482.","started":"2018-08-23","startedType":"actual","yearReported":2020,"enrolled":397,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Sintilimab + pemetrexed-platinum","n":266,"value":8.9},{"name":"Placebo + pemetrexed-platinum","n":131,"value":5}],"hr":0.482,"source":"https://doi.org/10.1016/j.jtho.2020.07.014"}]},{"id":"orient-16","kind":"trial","name":"ORIENT-16","aka":[],"tldr":"The Chinese stomach cancer trial that showed adding sintilimab to chemotherapy helps patients live longer, especially when the tumour expresses PD-L1.","summary":"650 patients. Median overall survival 15.2 versus 12.3 months in all randomised patients (hazard ratio 0.77) and 18.4 versus 12.9 months in the PD-L1 CPS 5 or higher group (hazard ratio 0.66), published in JAMA in 2023. NMPA approval 2023. With CheckMate 649, KEYNOTE-859 and RATIONALE-305 it makes gastric cancer the disease where Chinese PD-1 trials most changed global practice.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03745170","url":"https://clinicaltrials.gov/study/NCT03745170"},{"label":"JAMA 2023","url":"https://doi.org/10.1001/jama.2023.19918"}],"tags":["china"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sintilimab","oxaliplatin"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":["cps"],"trials":[],"people":["xu-jianming"],"bottlenecks":[],"keyPapers":["paper-xu-jama"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03745170","phase":"3","setting":"First-line unresectable gastric or gastro-oesophageal junction adenocarcinoma, China: sintilimab or placebo plus oxaliplatin and capecitabine","sponsor":"Innovent Biologics","result":"OS 15.2 vs 12.3 months (HR 0.77); CPS ≥5: 18.4 vs 12.9 months (HR 0.66).","started":"2018-12-19","startedType":"actual","yearReported":2023,"enrolled":650,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, all randomised","primary":true,"unit":"months","arms":[{"name":"Sintilimab + CAPOX","n":327,"value":15.2},{"name":"Placebo + CAPOX","n":323,"value":12.3}],"hr":0.77,"source":"https://doi.org/10.1001/jama.2023.19918"}]},{"id":"orient-32","kind":"trial","name":"ORIENT-32","aka":[],"tldr":"A Chinese trial showing that a PD-1 antibody plus a bevacizumab copy extends life in liver cancer, mirroring the global IMbrave150 result in a hepatitis B population.","summary":"571 patients randomised 2:1. Overall survival hazard ratio 0.57 (median not reached versus 10.4 months) and progression-free survival hazard ratio 0.56 at the first interim analysis; about 94% of patients had hepatitis B, the cause of most Chinese liver cancer. NMPA approval June 2021. With IMbrave150 it established anti-PD-(L)1 plus anti-VEGF as the first-line standard and gave China a reimbursed domestic option.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03794440","url":"https://clinicaltrials.gov/study/NCT03794440"},{"label":"Lancet Oncol 2021","url":"https://doi.org/10.1016/S1470-2045(21)00252-7"}],"tags":["china"],"related":[],"cancers":["hcc"],"sections":[],"technologies":["checkpoint-inhibitor","antiangiogenic"],"targets":[],"drugs":["sintilimab","bevacizumab","sorafenib"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":["hbv-hcv"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-ren-lancet-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03794440","phase":"2/3","setting":"First-line unresectable hepatocellular carcinoma, China (mostly hepatitis B-related): sintilimab plus the bevacizumab biosimilar IBI305 vs sorafenib","sponsor":"Innovent Biologics","result":"OS HR 0.57; PFS HR 0.56.","started":"2019-02-11","startedType":"actual","yearReported":2021,"enrolled":595,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Sintilimab + IBI305","n":380,"note":"Median not reached at interim analysis"},{"name":"Sorafenib","n":191,"value":10.4}],"hr":0.57,"source":"https://doi.org/10.1016/S1470-2045(21)00252-7"}]},{"id":"oriole","kind":"trial","name":"ORIOLE","aka":["ORIOLE","Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer"],"tldr":"Treating one to three secondary tumours with precise radiotherapy cut the chance of the cancer progressing within six months from three in five to one in five, and worked best when a PSMA scan showed nothing had been missed.","summary":"ORIOLE randomised 54 men with recurrent hormone-sensitive prostate cancer and one to three metastases on conventional imaging, 36 to stereotactic ablative radiotherapy and 18 to observation. Progression was defined by PSA rise, progression on conventional imaging, symptomatic progression, start of androgen deprivation for any reason, or death.\n\nProgression at 6 months occurred in 7 of 36 men (19 percent) after radiotherapy and 11 of 18 (61 percent) under observation (p=0.005). Median progression-free survival was not reached with radiotherapy against 5.8 months with observation, hazard ratio 0.30 (95 percent confidence interval 0.11 to 0.81, p=0.002). No toxic effects of grade 3 or greater were observed.\n\nThe finding that made ORIOLE more than a small positive trial is the imaging one. Men had PSMA PET that was not used for treatment planning, and total consolidation of all PSMA-avid disease reduced the risk of new lesions at 6 months from 63 to 16 percent (p=0.006). Treating what conventional imaging can see, while leaving what it cannot, is much less effective than treating everything.\n\nT-cell receptor sequencing showed significant clonotypic expansion after radiotherapy, and baseline clonality correlated with progression in the radiotherapy arm only, evidence that the effect is partly immunological. These are exploratory findings in 54 men and should be read as hypotheses.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02680587","url":"https://clinicaltrials.gov/study/NCT02680587"},{"label":"ORIOLE (JAMA Oncology 2020)","url":"https://doi.org/10.1001/jamaoncol.2020.0147"}],"tags":[],"related":[],"cancers":["prostate","prostate-bcr","prostate-mhspc"],"sections":[],"technologies":["sbrt","sabr-oligometastases","psma-pet"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["oligometastatic","biochemical-recurrence","psa"],"trials":["stomp-oligorecurrence","sabr-comet","propsma"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02680587","phase":"2","setting":"Recurrent hormone-sensitive prostate cancer with one to three metastases on conventional imaging, no androgen deprivation within 6 months of enrolment or 3 or more years in total: stereotactic ablative radiotherapy against observation, randomised 2:1, with progression at 6 months as the primary outcome","sponsor":"Johns Hopkins University","result":"Progression at 6 months 19 percent after stereotactic ablative radiotherapy against 61 percent under observation (p=0.005); total consolidation of PSMA-avid disease reduced new lesions at 6 months from 63 to 16 percent.","started":"2016-04-28","startedType":"actual","yearReported":2020,"enrolled":54,"enrolledBasis":"randomised","enrolledNote":"Of 80 men screened, 54 were randomised 2:1 between May 2016 and March 2018.","outcomes":[{"endpoint":"Progression at 6 months","primary":true,"unit":"%","arms":[{"name":"Stereotactic ablative radiotherapy","n":36,"value":19},{"name":"Observation","n":18,"value":61}],"p":"0.005","source":"https://doi.org/10.1001/jamaoncol.2020.0147"},{"endpoint":"Progression-free survival (median)","unit":"months","arms":[{"name":"Stereotactic ablative radiotherapy","n":36,"note":"not reached"},{"name":"Observation","n":18,"value":5.8}],"hr":0.3,"ci":[0.11,0.81],"p":"0.002","source":"https://doi.org/10.1001/jamaoncol.2020.0147"},{"endpoint":"New lesions at 6 months by total PSMA consolidation","unit":"%","arms":[{"name":"All PSMA-avid disease treated","value":16},{"name":"PSMA-avid disease left untreated","value":63}],"p":"0.006","source":"https://doi.org/10.1001/jamaoncol.2020.0147"}],"replication":"STOMP found the same direction in 62 men with an androgen deprivation-free survival endpoint; neither trial was powered for survival and the phase 3 trials are still running."},{"id":"nct06998407","kind":"trial","name":"ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors","aka":["ORION-1"],"tldr":"A phase 1/2 trial of AVZO-021 and Fulvestrant in advanced solid tumours, run by Avenzo Therapeutics, Inc., now recruiting.","summary":"ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06998407 by Avenzo Therapeutics, Inc., with 380 participants planned, started 2025-08-20 and due to reach its primary completion in 2028-08. Interventions recorded: AVZO-021, Fulvestrant, Letrozole and AVZO-023.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06998407","url":"https://clinicaltrials.gov/study/NCT06998407"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["avzo-021","fulvestrant","avzo-023"],"companies":["avenzo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06998407","phase":"1/2","setting":"A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-023 as a Single Agent, and in Combination With AVZO-021 and/or Endocrine Therapy in Patients With Advanced Solid Tumors","sponsor":"Avenzo Therapeutics, Inc.","started":"2025-08-20","startedType":"actual","enrolled":380,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04410796","kind":"trial","name":"Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers","aka":[],"tldr":"A phase 2 trial of osimertinib, carboplatin and pemetrexed in lung cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers is a phase 2, randomised interventional study registered as NCT04410796 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 571 participants, started 2020-05-28 and due to reach its primary completion in 2027-05. Interventions recorded: Osimertinib; Carboplatin; Pemetrexed. Conditions listed: Metastatic Non-small Cell Lung Cancer. Primary outcome: Determine the progression-free survival. Lung eligibility wording from the registry: \"* Biopsy proven metastatic non-small cell lung cancer, confirmed at enrolling institution\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04410796","url":"https://clinicaltrials.gov/study/NCT04410796"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","platinum"],"targets":[],"drugs":["osimertinib","carboplatin","pemetrexed"],"companies":["astrazeneca","guardant-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04410796","phase":"2","setting":"A Phase 2 Randomized Study of Osimertinib Versus Osimertinib Plus Chemotherapy for Patients With Metastatic EGFR-Mutant Lung Cancers That Have Detectable EGFR-Mutant cfDNA in Plasma After Initiation of Osimertinib","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2020-05-28","startedType":"actual","enrolled":571,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07295821","kind":"trial","name":"Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study","aka":[],"tldr":"A phase 2 trial of Osimertinib in advanced solid tumours, run by AstraZeneca, now recruiting.","summary":"Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study is a phase 2 interventional study registered as NCT07295821 by AstraZeneca, with 60 participants planned, started 2026-04-01 and due to reach its primary completion in 2029-05-30. Interventions recorded: Osimertinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07295821","url":"https://clinicaltrials.gov/study/NCT07295821"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07295821","phase":"2","setting":"Phase II, Single-arm Multicenter Study of Osimertinib Induction Before Radiotherapy and Maintenance in Chemo-ineligible or Refusing Patients With Stage III, Unresectable NSCLC and EGFR Mutation-positive Tumors","sponsor":"AstraZeneca","started":"2026-04-01","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04695925","kind":"trial","name":"Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations","aka":["TOP"],"tldr":"A phase 3 trial of osimertinib, pemetrexed and carboplatin in lung cancer, run by Li Zhang, MD, active but no longer recruiting.","summary":"Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations is a phase 3, randomised interventional study registered as NCT04695925 by Li Zhang, MD, with a registry enrolment figure of 294 participants, started 2021-03-29 and due to reach its primary completion in 2025-11-01. Interventions recorded: Osimertinib; Pemetrexed; Carboplatin. Conditions listed: Non-small Cell Carcinoma; EGFR Gene Mutation. Primary outcome: progression free survival. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed stage IV or recurrent non-squamous non-small cell lung carcinoma with activating EGFR mutations (exon 19 deletion or exon 21 L858R point mutation) and concurrent TP53 mutations;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04695925","url":"https://clinicaltrials.gov/study/NCT04695925"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","platinum"],"targets":[],"drugs":["osimertinib","pemetrexed","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04695925","phase":"3","setting":"A Phase III, Multicentre, Randomized Controlled Study Comparing Osimertinib Monotherapy to Combination Therapy With Osimertinib, Carboplatin and Pemetrexed for Untreated Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer With Concurrent EGFR and TP53 Mutations(TOP)","sponsor":"Li Zhang, MD","started":"2021-03-29","startedType":"actual","enrolled":294,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03778229","kind":"trial","name":"Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib","aka":["SAVANNAH"],"tldr":"A phase 2 trial of Osimertinib and Savolitinib in advanced solid tumours, run by AstraZeneca, active and no longer recruiting.","summary":"Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib is a phase 2 interventional study registered as NCT03778229 by AstraZeneca, with 367 participants enrolled, started 2019-01-09 and due to reach its primary completion in 2024-08-23. Interventions recorded: osimertinib, savolitinib and placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03778229","url":"https://clinicaltrials.gov/study/NCT03778229"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","egfr-mutant-nsclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib","savolitinib"],"companies":["astrazeneca","hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03778229-ann-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03778229","phase":"2","setting":"A Phase II Study Assessing the Efficacy of Osimertinib in Combination With Savolitinib in Patients With EGFRm+ and MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Progressed Following Treatment With Osimertinib.","sponsor":"AstraZeneca","started":"2019-01-09","startedType":"actual","yearReported":2026,"enrolled":367,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR) by Investigator Assessment; Target Population Analysis Set","primary":true,"unit":"%","arms":[{"name":"Savo 300 mg BID + Osi","n":80,"value":56.3,"note":"95% CI 44.70 to 67.32; Figures from the ClinicalTrials.gov results section (first posted 2026-02-10), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03778229?tab=results"},{"endpoint":"Objective Response Rate (ORR) by Investigator Assessment; 300 mg QD Safety Analysis Set","primary":true,"unit":"%","arms":[{"name":"Savo 300 mg QD + Osi","n":196,"value":31.6,"note":"95% CI 25.19 to 38.64; Figures from the ClinicalTrials.gov results section (first posted 2026-02-10), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03778229?tab=results"},{"endpoint":"Overall Survival (OS); Target Population Analysis Set","unit":"months","arms":[{"name":"Savo 300 mg BID + Osi","n":80,"value":14.42,"note":"95% CI 11.89 to 17.87; Figures from the ClinicalTrials.gov results section (first posted 2026-02-10), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03778229?tab=results"}]},{"id":"nct04335292","kind":"trial","name":"Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer with Osimertinib Third-line Rechallenge","aka":["OCELOT"],"tldr":"A phase 2 trial in lung cancer, run by Mark Vincent, now recruiting.","summary":"Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer with Osimertinib Third-line Rechallenge is a phase 2, interventional study registered as NCT04335292 by Mark Vincent, with a registry enrolment figure of 200 participants, started 2021-01-06 and due to reach its primary completion in 2026-06-01. Interventions recorded: Osimertinib First-Line; Platinum + Pemetrexed Chemotherapy Second-Line; Osimertinib Third-Line. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Objective Response Rate according to Response Evaluation Criteria in Solid Tumors version 1.1. Lung eligibility wording from the registry: \"* Pathologically proven advanced non-small cell lung cancer (i\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04335292","url":"https://clinicaltrials.gov/study/NCT04335292"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04335292","phase":"2","setting":"Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer with Osimertinib Third-line Rechallenge","sponsor":"Mark Vincent","started":"2021-01-06","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04181060","kind":"trial","name":"Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer","aka":[],"tldr":"A phase 3 trial of bevacizumab and osimertinib in lung cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer is a phase 3, randomised interventional study registered as NCT04181060 by National Cancer Institute (NCI), with a registry enrolment figure of 300 participants, started 2020-12-28 and due to reach its primary completion in 2026-12-31. Interventions recorded: Bevacizumab; Biospecimen Collection; Computed Tomography; Echocardiography Test; Magnetic Resonance Imaging; Multigated Acquisition Scan; Osimertinib. Conditions listed: Advanced Lung Non-Squamous Non-Small Cell Carcinoma; Metastatic Lung Non-Squamous Non-Small Cell Carcinoma; Recurrent Lung Non-Squamous Non-Small Cell Carcinoma; Stage IIIB Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8. Primary outcome: Progression-free survival (PFS). Lung eligibility wording from the registry: \"* Patient must have a pathologically-confirmed diagnosis of non-squamous, non-small cell lung cancer (NSCLC)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04181060","url":"https://clinicaltrials.gov/study/NCT04181060"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["bevacizumab","osimertinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04181060","phase":"3","setting":"Randomized Phase III Study of Combination Osimertinib (AZD9291) and Bevacizumab Versus Osimertinib (AZD9291) Alone as First-Line Treatment for Patients With Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)","sponsor":"National Cancer Institute (NCI)","started":"2020-12-28","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07738172","kind":"trial","name":"Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung Cancer","aka":["PTR-2"],"tldr":"A phase 3 trial of osimertinib in lung cancer, run by National Taiwan University Hospital, now recruiting.","summary":"Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT07738172 by National Taiwan University Hospital, with a registry enrolment figure of 154 participants, started 2026-09-08 and due to reach its primary completion in 2031-08-01. Interventions recorded: Primary Tumor Resection; Osimertinib. Conditions listed: Lung Neoplasms, Non-Small Cell Lung Cancer. Primary outcome: Progression-Free Survival. Lung eligibility wording from the registry: \"Patients must meet the baseline eligibility criteria, including stage IV NSCLC, EGFR sensitizing mutation (exon 19 deletion or L858R), resectable dominant primary lung lesion, and adequate performance status and organ function\". Sites: Taiwan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07738172","url":"https://clinicaltrials.gov/study/NCT07738172"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07738172","phase":"3","setting":"A Multicenter, Randomized Controlled Phase III Clinical Trial of Primary Tumor Resection in Patients With Oligometastatic EGFR-Mutant Non-Small Cell Lung Cancer After EGFR-Targeted Therapy","sponsor":"National Taiwan University Hospital","started":"2026-09-08","startedType":"estimated","enrolled":154,"enrolledBasis":"registry","outcomes":[]},{"id":"osmanabad-hpv-screening","kind":"trial","name":"Osmanabad cervical screening trial (HPV testing vs cytology vs VIA)","aka":[],"tldr":"One round of HPV testing in rural Indian villages halved deaths from cervical cancer within eight years, while a Pap smear or a visual check did not, which is why HPV tests are now the world's preferred screen.","summary":"131,746 women aged 30 to 59 in 52 village clusters were randomised to HPV testing (34,126), cytology (32,058), visual inspection with acetic acid (34,074) or standard care (31,488). In the HPV arm there were 39 advanced cancers versus 82 in the control group (hazard ratio 0.47; 95% CI 0.32-0.69) and 34 cervical cancer deaths versus 64 (hazard ratio 0.52; 95% CI 0.33-0.83); neither cytology nor visual inspection significantly reduced advanced cancers or deaths, and adverse events occurred in 0.1% of screened women. The result made a single round of HPV testing the evidence base for WHO's HPV-first screening recommendation and for India's own screening guidance.","status":"positive","asOf":"2026-09-10","links":[{"label":"Sankaranarayanan et al., NEJM 2009","url":"https://doi.org/10.1056/NEJMoa0808516"}],"tags":[],"related":[],"cancers":["cervical"],"sections":[],"technologies":["hpv-testing","colposcopy-excision"],"targets":[],"drugs":[],"companies":[],"institutions":["iarc","tata-memorial"],"pathways":[],"terms":[],"trials":[],"people":["sankaranarayanan-rengaswamy"],"bottlenecks":["b-early-detection","b-prevention-adoption","b-global-access"],"keyPapers":["paper-sankaranarayanan-hpv-screening-nejm-2009"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Cluster-randomised trial in 52 villages of Osmanabad district, Maharashtra: one round of HPV DNA testing, cytology, visual inspection with acetic acid, or usual care in women aged 30-59","sponsor":"IARC with Nargis Dutt Memorial Cancer Hospital, Barshi, and the Tata Memorial Centre","result":"Cervical cancer deaths HR 0.52 with one round of HPV testing; no significant effect of cytology or VIA.","yearReported":2009,"enrolled":131746,"enrolledBasis":"registry","outcomes":[{"endpoint":"Cervical cancer deaths","primary":true,"unit":"deaths","arms":[{"name":"HPV testing","n":34126,"value":34},{"name":"Control","n":31488,"value":64}],"hr":0.52,"ci":[0.33,0.83],"source":"https://doi.org/10.1056/NEJMoa0808516"}]},{"id":"nct04974008","kind":"trial","name":"Osteosarcoma Maintenance Therapy With OST31-164","aka":[],"tldr":"A phase 2 trial of OST31-164 in advanced solid tumours, run by Emerald Clinical Inc., active and no longer recruiting.","summary":"Osteosarcoma Maintenance Therapy With OST31-164 is a phase 2 interventional study registered as NCT04974008 by Emerald Clinical Inc., with 39 participants enrolled, started 2021-10-21 and due to reach its primary completion in 2023-09-21. Interventions recorded: OST31-164.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04974008","url":"https://clinicaltrials.gov/study/NCT04974008"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04974008","phase":"2","setting":"An Open-Label Phase 2 Study of Maintenance Therapy With OST31-164 After Resection of Recurrent Osteosarcoma","sponsor":"Emerald Clinical Inc.","started":"2021-10-21","startedType":"actual","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06226857","kind":"trial","name":"Other Oncogene Mutations for Anti-EGFR Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer","aka":["CRC01"],"tldr":"A phase 3 trial of cetuximab in colorectal cancer, run by City Clinical Oncology Hospital No 1, now recruiting.","summary":"Other Oncogene Mutations for Anti-EGFR Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT06226857 by City Clinical Oncology Hospital No 1, with a registry enrolment figure of 355 participants, started 2024-01-17 and due to reach its primary completion in 2026-12-31. Interventions recorded: Cetuximab. Conditions listed: Colorectal Neoplasms; Chemotherapy Effect; Molecular Sequence Variation. Primary outcome: progression-free survival. Colorectal eligibility wording from the registry: \"Verified diagnosis of colorectal adenocarcinoma (C18\". Sites: Russia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06226857","url":"https://clinicaltrials.gov/study/NCT06226857"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06226857","phase":"3","setting":"Predictive Value of Other Oncogene Mutations for Anti-EGFR Monoclonal Antibodies Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer: Multicenter Randomized Phase III Trial","sponsor":"City Clinical Oncology Hospital No 1","started":"2024-01-17","startedType":"actual","enrolled":355,"enrolledBasis":"registry","outcomes":[]},{"id":"outback","kind":"trial","name":"OUTBACK / ANZGOG 0902 / GOG-0274","aka":[],"tldr":"Giving extra chemotherapy after chemoradiation added side effects and no survival benefit, so timing matters: chemotherapy helps before radiation (INTERLACE), not after.","summary":"OUTBACK, also ANZGOG 0902 and GOG-0274, trial NCT01414608 sponsored by ANZGOG and NRG Oncology and published in Lancet Oncology in 2023, showed that giving four cycles of carboplatin and paclitaxel after chemoradiation for locally advanced cervical cancer adds side effects and no survival benefit. It randomised 919 patients, found no difference in overall or progression-free survival at five years, and 22 percent of the adjuvant arm never received the planned chemotherapy while severe toxicity rose sharply. OnCo links it to cervical cancer, modern radiotherapy, carboplatin, paclitaxel, NRG Oncology, the GOG Foundation, Linda Mileshkin and the pairing of induction chemotherapy before chemoradiation. Set beside INTERLACE, it shows that timing matters: chemotherapy helps before radiation, not after, and why that should be so is the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01414608","url":"https://clinicaltrials.gov/study/NCT01414608"},{"label":"Lancet Oncology 2023","url":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00147-X/fulltext"}],"tags":["failure","lesson:timing"],"related":[],"cancers":["cervical","locally-advanced-cervical-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["carboplatin","paclitaxel"],"companies":["nrg-oncology","gog-foundation"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["linda-mileshkin"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01414608","phase":"3","setting":"Locally advanced cervical cancer: chemoradiation followed by 4 cycles adjuvant carboplatin-paclitaxel vs chemoradiation alone","sponsor":"ANZGOG / NRG Oncology","result":"5-year OS 72% vs 71%; no benefit.","started":"2012-01-09","startedType":"actual","yearReported":2021,"enrolled":926,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 5 years","primary":true,"unit":"%","arms":[{"name":"CRT + adjuvant chemo","n":463,"value":72},{"name":"CRT alone","n":456,"value":71}],"hr":0.91,"ci":[0.7,1.18],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00147-X/fulltext"}]},{"id":"nct04906395","kind":"trial","name":"Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer","aka":["OVELIA"],"tldr":"A phase 3 trial of Tamoxifen and Exemestane in advanced solid tumours, run by Tolmar Inc., active and no longer recruiting.","summary":"Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer is a phase 3 interventional study registered as NCT04906395 by Tolmar Inc., with 250 participants enrolled, started 2021-07-01 and due to reach its primary completion in 2026-04-30. Interventions recorded: TOL2506, Tamoxifen, Letrozole Tablets, Anastrozole Tablets and Exemestane Tablets.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04906395","url":"https://clinicaltrials.gov/study/NCT04906395"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tamoxifen","exemestane","leuprolide"],"companies":["tolmar"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04906395","phase":"3","setting":"Phase 3,Single Arm,Open-Label Study Evaluating Ovarian Suppression Following 3 Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination With Endocrine Therapy in Premenopausal Subjects With Hormone-Receptor-Positive (HR+),Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer","sponsor":"Tolmar Inc.","started":"2021-07-01","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"ovhipec-1","kind":"trial","name":"OVHIPEC-1","aka":[],"tldr":"Washing the abdomen with heated chemotherapy during interval surgery extended survival by about a year.","summary":"OVHIPEC-1, trial NCT00426257 sponsored by the Netherlands Cancer Institute and reported in the New England Journal of Medicine in 2018, showed that washing the abdomen with heated cisplatin during interval cytoreductive surgery for stage III ovarian cancer after neoadjuvant chemotherapy extended survival by about a year. It randomised 245 patients to surgery with or without hyperthermic intraperitoneal chemotherapy, improved overall survival without increasing serious complications, and the benefit held at ten-year follow-up published in Lancet Oncology in 2023. OnCo links it to ovarian cancer, HIPEC and PIPAC intraperitoneal chemotherapy, the Netherlands Cancer Institute, Willemien J. van Driel and the pairing of HIPEC at interval surgery. Uptake remains uneven, and whether HIPEC also helps at primary surgery, which OVHIPEC-2 is testing, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00426257","url":"https://clinicaltrials.gov/study/NCT00426257"},{"label":"NEJM 2018","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1708618"}],"tags":[],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["hipec"],"targets":[],"drugs":[],"companies":[],"institutions":["nki"],"pathways":[],"terms":[],"trials":[],"people":["willemien-van-driel"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00426257","phase":"3","setting":"Stage III ovarian cancer at interval cytoreductive surgery after neoadjuvant chemotherapy: HIPEC with cisplatin vs surgery alone","sponsor":"Netherlands Cancer Institute","result":"OS 45.7 vs 33.9 months (HR 0.67).","started":"2007-02","yearReported":2018,"enrolled":245,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Surgery + HIPEC","n":122,"value":45.7},{"name":"Surgery alone","n":123,"value":33.9}],"hr":0.67,"ci":[0.48,0.94],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1708618"}],"replication":"Korean trial (Lim et al., JAMA Surgery 2022) showed benefit in the interval-surgery subgroup; OVHIPEC-2 (primary surgery) ongoing."},{"id":"nct00268463","kind":"trial","name":"Oxaliplatin and Capecitabine With or Without an Hepatic Arterial Infusion With Floxuridine in Treating Patients Who Are Undergoing Surgery and/or Ablation for Liver Metastases Due to Colorectal Cancer","aka":[],"tldr":"A phase 3 trial of Capecitabine, Floxuridine and Oxaliplatin in Colorectal cancer and Metastatic cancer, run by NSABP Foundation Inc, recorded as terminated on the registry.","summary":"Oxaliplatin and Capecitabine With or Without an Hepatic Arterial Infusion With Floxuridine in Treating Patients Who Are Undergoing Surgery and/or Ablation for Liver Metastases Due to Colorectal Cancer is a phase 3 interventional study registered as NCT00268463 by NSABP Foundation Inc, with 22 participants recorded, started 2006-01 and due to reach its primary completion in 2008-06. Interventions recorded: capecitabine, floxuridine, oxaliplatin. Conditions recorded: Colorectal Cancer, Metastatic Cancer.\n\nLinked to the drug Floxuridine because the registry names it among its interventions and Colorectal cancer and Metastatic cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00268463","url":"https://clinicaltrials.gov/study/NCT00268463"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["capecitabine","floxuridine","oxaliplatin"],"companies":["nsabp-foundation"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00268463","phase":"3","setting":"A Phase III Clinical Trial Comparing Oxaliplatin, Capecitabine and Hepatic Arterial Infusion of Floxuridine to Oxaliplatin and Capecitabine in Patients With Resected or Ablated Liver Metastases From Colorectal Cancer","sponsor":"NSABP Foundation Inc","started":"2006-01","enrolled":22,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06468033","kind":"trial","name":"P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk","aka":["HOPE-PMF"],"tldr":"A phase 3 trial of Ropeginterferon alfa-2b in myeloproliferative neoplasms, run by PharmaEssentia, active and no longer recruiting.","summary":"P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk is a phase 3 interventional study registered as NCT06468033 by PharmaEssentia, with 160 participants enrolled, started 2025-07-18 and due to reach its primary completion in 2027-11-18. Interventions recorded: Ropeginterferon alfa-2b, Placebo. Conditions listed: Primary Myelofibrosis, Myeloproliferative Neoplasm. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06468033","url":"https://clinicaltrials.gov/study/NCT06468033"}],"tags":["ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","primary-myelofibrosis"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["ropeginterferon-alfa-2b"],"companies":["pharmaessentia"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06468033","phase":"3","setting":"A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Study to Assess Efficacy and Safety of Ropeginterferon Alfa-2b (P1101) in Adult Patients With Pre-fibrotic/Early Primary Myelofibrosis (PMF) or Overt PMF at Low or Intermediate-1 Risk According to DIPSS Plus (HOPE-PMF): The Core Study and Its Extension Study","sponsor":"PharmaEssentia","started":"2025-07-18","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03268382","kind":"trial","name":"p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246","aka":["PiSARRO-R"],"tldr":"A phase 2 trial of Eprenetapopt and Pegylated liposomal doxorubicin in Ovarian cancer, run by Aprea Therapeutics, completed.","summary":"p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246 is a phase 2 interventional study registered as NCT03268382 by Aprea Therapeutics, with 36 participants recorded, started 2017-07-31 and reaching its primary completion in 2019-07-10. Interventions recorded: APR-246, Pegylated Liposomal Doxorubicin Hydrochloride (PLD). Conditions recorded: High-grade Serous Ovarian Cancer.\n\nLinked to the idea \"Is aneuploidy itself a druggable vulnerability?\" because the registry names Eprenetapopt and Pegylated liposomal doxorubicin among its interventions and Ovarian cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03268382","url":"https://clinicaltrials.gov/study/NCT03268382"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["eprenetapopt","pegylated-liposomal-doxorubicin"],"companies":["aprea-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03268382","phase":"2","setting":"PiSARRO-R: p53 Suppressor Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Phase II Study of Systemic Pegylated Liposomal Doxorubicin Chemotherapy With APR-246","sponsor":"Aprea Therapeutics","started":"2017-07-31","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06102057","kind":"trial","name":"PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC","aka":["PACCELIO"],"tldr":"A phase 2 trial in lung cancer, run by TheraOp, now recruiting.","summary":"PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC is a phase 2, randomised interventional study registered as NCT06102057 by TheraOp, with a registry enrolment figure of 110 participants, started 2024-07-01 and due to reach its primary completion in 2026-06. Interventions recorded: standard Radiotherapy; Chemotherapy; Immunotherapy; Experimental Radiotherapy. Conditions listed: Stage III Non-small Cell Lung Cancer; Locally Advanced; Unresectable. Primary outcome: Comparison of the Completion rate of Experimental Arm to Conventional Arm. Lung eligibility wording from the registry: \"* Patients with histologically or cytologically documented NSCLC who present with locally advanced, unresectable (Stage III) disease (according to version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology (IASLC Staging Manual in Thoracic Oncology 20\". Sites: Germany, Switzerland. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06102057","url":"https://clinicaltrials.gov/study/NCT06102057"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06102057","phase":"2","setting":"PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC","sponsor":"TheraOp","started":"2024-07-01","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"pace-b","kind":"trial","name":"PACE-B","aka":[],"tldr":"PACE-B showed that five stereotactic treatments control low- and intermediate-risk prostate cancer as well as four to eight weeks of conventional radiotherapy, with similar side effects at five years.","summary":"PACE-B randomised 874 men to stereotactic body radiotherapy (36.25 Gy in five fractions over one to two weeks) or conventional radiotherapy (78 Gy in 39 or 62 Gy in 20 fractions), without hormone therapy. Five-year freedom from biochemical or clinical failure was 95.8 percent with SBRT and 94.6 percent with conventional treatment, meeting non-inferiority; genitourinary toxicity of grade 2 or worse was somewhat higher after SBRT (van As and colleagues, New England Journal of Medicine 2024). Five-fraction treatment is now a standard option.","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01584258","url":"https://clinicaltrials.gov/study/NCT01584258"},{"label":"NEJM 2024","url":"https://doi.org/10.1056/NEJMoa2403365"},{"label":"PACE-B (New England Journal of Medicine 2024)","url":"https://doi.org/10.1056/NEJMoa2403365"},{"label":"PACE-B 5-year patient-reported outcomes (European Urology 2026)","url":"https://doi.org/10.1016/j.eururo.2026.05.034"},{"label":"PACE-B late urinary toxicity factors (European Urology 2026)","url":"https://doi.org/10.1016/j.eururo.2025.07.007"}],"tags":["radiation-wave2"],"related":[],"cancers":["prostate","prostate-low-risk","prostate-intermediate-risk"],"sections":[],"technologies":["sbrt","hypofractionated-radiotherapy"],"targets":[],"drugs":[],"companies":[],"institutions":["royal-marsden","icr-london"],"pathways":[],"terms":["prostate-radiotherapy-fractionation","prostate-treatment-choice-localised"],"trials":["hypo-rt-pc","chhip","partiqol"],"people":["nicholas-van-as"],"bottlenecks":[],"keyPapers":["paper-van-as-n-engl-j-med","paper-pace-b-lancet-oncol-2019","paper-pace-b-lancet-oncol-2022-update"],"journals":[],"dependsOn":[],"notes":["PACE-B enrolled men with stage T1 or T2 prostate cancer, a Gleason score of 3+4 or less and a PSA of no more than 20 ng/mL. Androgen deprivation was not permitted. Median age was 69.8 years, median PSA 8.0 ng/mL, and the NCCN risk category was low for 8.4 percent and intermediate for 91.6 percent. Median follow-up was 74.0 months (New England Journal of Medicine 2024).","The 5-year patient-reported outcomes, presented as waffle charts so they can be compared with surgical series, are the figures to quote to a man choosing between radiotherapy and an operation. Leak-free rates were 64 percent (164 of 258) after stereotactic body radiotherapy and 69 percent (172 of 249) after conventional radiotherapy; pad-free rates 91 percent (233 of 257) and 90 percent (225 of 250); moderate or big urinary leakage problems 6 percent (15 of 250) and 4 percent (9 of 244). Erections adequate for intercourse fell from 35 percent (133 of 374) to 17 percent (43 of 250) after stereotactic radiotherapy and from 40 percent (157 of 391) to 20 percent (47 of 240) after conventional radiotherapy. Moderate or big bowel problems rose from 2 percent at baseline to 5 percent in both arms (European Urology 2026).","A separate PACE-B analysis of 390 men with dose-volume histogram data found grade 2 or higher urinary toxicity at 2 years in 12 percent (44 of 357 with data), associated with higher baseline International Prostate Symptom Score (odds ratio 1.11 per point, 95 percent confidence interval 1.05 to 1.18, p=0.001), baseline urinary medication use (2.32, 1.09 to 4.95, p=0.03) and grade 2 or higher acute urinary toxicity (3.15, 1.35 to 7.37, p=0.008). No association was seen with dose to urinary substructures. The authors recommend counselling men with worse baseline urinary symptoms about their elevated risk and considering moderate hypofractionation for them (European Urology 2026)."],"nct":"NCT01584258","phase":"3","setting":"Low- and intermediate-risk prostate cancer: stereotactic body radiotherapy in five fractions versus conventional or moderately hypofractionated radiotherapy","sponsor":"Royal Marsden NHS Foundation Trust","result":"5-year biochemical or clinical failure-free 95.8% (SBRT) vs 94.6% (conventional), non-inferior.","started":"2012-08-07","startedType":"actual","yearReported":2024,"enrolled":874,"enrolledBasis":"randomised","enrolledNote":"874 men underwent randomisation at 38 centres between August 2012 and January 2018, 433 to stereotactic body radiotherapy and 441 to control radiotherapy.","outcomes":[{"endpoint":"Freedom from biochemical or clinical failure at 5 years","primary":true,"unit":"%","arms":[{"name":"SBRT 36.25 Gy in 5","n":433,"value":95.8},{"name":"Conventional radiotherapy","n":441,"value":94.6}]},{"endpoint":"Freedom from biochemical or clinical failure at 5 years","primary":true,"unit":"%","arms":[{"name":"Stereotactic body radiotherapy, 36.25 Gy in 5 fractions","n":433,"value":95.8,"note":"Confidence interval is 90 percent, as prespecified; critical hazard ratio for non-inferiority 1.45."},{"name":"Control radiotherapy, 78 Gy in 39 or 62 Gy in 20 fractions","n":441,"value":94.6}],"hr":0.73,"ci":[0.48,1.12],"p":"0.004 for non-inferiority","source":"https://doi.org/10.1056/NEJMoa2403365"},{"endpoint":"Late RTOG grade 2 or higher genitourinary toxicity at 5 years","unit":"%","arms":[{"name":"Stereotactic body radiotherapy","n":433,"value":26.9},{"name":"Control radiotherapy","n":441,"value":18.3}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa2403365"},{"endpoint":"Late RTOG grade 2 or higher gastrointestinal toxicity at 5 years","unit":"%","arms":[{"name":"Stereotactic body radiotherapy","n":433,"value":10.7},{"name":"Control radiotherapy","n":441,"value":10.2}],"p":"0.94","source":"https://doi.org/10.1056/NEJMoa2403365"}],"replication":"HYPO-RT-PC found seven-fraction ultra-hypofractionation non-inferior in 1,180 men, with the same pattern of worse acute and similar late toxicity."},{"id":"nct05236972","kind":"trial","name":"PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer","aka":["PACE"],"tldr":"A phase 3 trial of sintilimab, fOLFOX (5-FU, leucovorin, oxaliplatin) and capecitabine in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer is a phase 3, randomised interventional study registered as NCT05236972 by Sun Yat-sen University, with a registry enrolment figure of 323 participants, started 2022-01-01 and due to reach its primary completion in 2026-06-01. Interventions recorded: Sintilimab; Oxaliplatin; capecitabine. Conditions listed: Colorectal Carcinoma. Primary outcome: Disease Free survival [ Time Frame: 3 years ]. Colorectal eligibility wording from the registry: \", any T, N1 or N2, M0) adenocarcinoma of the colon (as defined by the presence of the inferior pole of the tumour above the peritoneal reflection - that is, at least 10 cm from the anal margin)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05236972","url":"https://clinicaltrials.gov/study/NCT05236972"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["sintilimab","folfox","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05236972","phase":"3","setting":"Study of Sintilimab vs Standard Therapy in Participants With Mismatch Repair Deficient (dMMR) or Microsatellite Instability-High (MSI-H) Stage III Colorectal Cancer","sponsor":"Sun Yat-sen University","started":"2022-01-01","startedType":"actual","enrolled":323,"enrolledBasis":"registry","outcomes":[]},{"id":"pacific","kind":"trial","name":"PACIFIC","aka":[],"tldr":"Made a year of immunotherapy after chemoradiation the standard for stage III lung cancer, with a survival benefit that held at five years.","summary":"PACIFIC, trial NCT02125461 sponsored by AstraZeneca and reported in 2017, made a year of durvalumab after chemoradiation the standard for unresectable stage III non-small-cell lung cancer. It randomised 713 patients without progression after chemoradiation to durvalumab or placebo, met its primary progression-free survival endpoint by blinded review, and went on to show an overall survival benefit that held at five years, establishing consolidation immunotherapy as a concept. Its findings were reproduced in the real-world PACIFIC-R cohort and by GEMSTONE-301 with sugemalimab, and OnCo links it to Scott J. Antonia and to the chemoradiation and consolidation therapy terms. The benefit was weaker in EGFR-mutant disease, where LAURA now applies, and whether shorter or biomarker-guided consolidation could match a full year is the open question. Durvalumab has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT02125461","url":"https://clinicaltrials.gov/study/NCT02125461"}],"tags":[],"related":[],"cancers":["nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["imrt-igrt","checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["scott-antonia"],"bottlenecks":[],"keyPapers":["paper-pacific-nejm-2017","paper-pacific-n-engl-j-med-2018-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02125461","phase":"3","setting":"Unresectable stage III NSCLC without progression after chemoradiation: durvalumab 1 year vs placebo","sponsor":"AstraZeneca","result":"OS HR 0.68; 5-year OS 42.9% vs 33.4%.","started":"2014-05-07","startedType":"actual","yearReported":2017,"enrolled":713,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Durvalumab","n":476,"value":16.8},{"name":"Placebo","n":237,"value":5.6}],"hr":0.52,"ci":[0.42,0.65],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1709937"},{"endpoint":"Overall survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Durvalumab","value":42.9},{"name":"Placebo","value":33.4}],"hr":0.72,"ci":[0.59,0.89],"source":"https://ascopubs.org/doi/10.1200/JCO.21.01308"}],"replication":"Confirmed by the real-world PACIFIC-R cohort and by GEMSTONE-301 (sugemalimab) in the same setting."},{"id":"pacific-2","kind":"trial","name":"PACIFIC-2","aka":[],"tldr":"PACIFIC-2 asked whether starting durvalumab during chemoradiotherapy, rather than after it, would help people with stage III lung cancer; it did not, so the sequence established by the original PACIFIC trial stands.","summary":"PACIFIC established durvalumab given after chemoradiotherapy as the standard for unresectable stage III non-small-cell lung cancer. PACIFIC-2 tested the more aggressive schedule of starting durvalumab at the same time as platinum-based chemoradiotherapy and continuing it afterwards, against placebo, in 328 patients. The primary endpoint was progression-free survival.\n\nThe trial did not show a statistically significant improvement in progression-free survival, and more patients in the durvalumab arm stopped treatment early for adverse events. Consolidation after chemoradiotherapy therefore remains the way durvalumab is used in this setting.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03519971","url":"https://clinicaltrials.gov/study/NCT03519971"}],"tags":["subtype-trials"],"related":[],"cancers":["stage-iii-unresectable-nsclc","nsclc","lung-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","cisplatin","carboplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jeffrey-bradley"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03519971","phase":"3","setting":"Unresectable stage III non-small-cell lung cancer: durvalumab or placebo given together with platinum chemoradiotherapy and continued afterwards","sponsor":"AstraZeneca","result":"Concurrent durvalumab with chemoradiotherapy did not significantly improve progression-free survival over chemoradiotherapy alone.","started":"2018-03-29","startedType":"actual","yearReported":2024,"enrolled":328,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (registry results)","primary":true,"unit":"months","arms":[{"name":"Durvalumab + concurrent chemoradiotherapy","value":13.8,"note":"95% CI 9.5 to 16.9"},{"name":"Placebo + concurrent chemoradiotherapy","value":9.4,"note":"95% CI 7.5 to 16.6"}],"hr":0.85,"ci":[0.647,1.123],"p":"0.247","source":"https://clinicaltrials.gov/study/NCT03519971?tab=results"}]},{"id":"nct07739485","kind":"trial","name":"Paclitaxel Oral Solution in Triple Neagtive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study","aka":["GBCF003"],"tldr":"A phase 1/2 trial of epirubicin in triple-negative breast cancer, run by Liu Shu, now recruiting.","summary":"Paclitaxel Oral Solution in Triple Neagtive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study is a phase 1/2, interventional study registered as NCT07739485 by Liu Shu, with a registry enrolment figure of 30 participants, started 2026-07-30 and due to reach its primary completion in 2027-07-30. Interventions recorded: Epirubicin and cyclophosphamide followed by paclitaxel oral solution. Conditions listed: Triple -Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Triple-negative breast cancer (TNBC) is defined as ER \\<1%, PR \\<1%, and HER2-negative \\[IHC 0, IHC 1+, or IHC 2+ with FISH-negative\\]\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07739485","url":"https://clinicaltrials.gov/study/NCT07739485"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["epirubicin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07739485","phase":"1/2","setting":"A Dose-Finding Study of Paclitaxel Oral Solution in Neoadjuvant Therapy for Patients With Triple Negative Breast Cancer","sponsor":"Liu Shu","started":"2026-07-30","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06910072","kind":"trial","name":"Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer（UPGRADE-TN","aka":["UPGRADE-TNBC"],"tldr":"A phase 2/3 trial of carboplatin in triple-negative breast cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer（UPGRADE-TNBC） is a phase 2/3, interventional study registered as NCT06910072 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 32 participants, started 2025-07-21 and due to reach its primary completion in 2027-06-01. Interventions recorded: paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab. Conditions listed: Triple-Negative Breast Cancer (TNBC); Neoadjuvant Therapy. Triple-negative eligibility wording from the registry: \"* Triple-negative breast cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06910072","url":"https://clinicaltrials.gov/study/NCT06910072"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06910072","phase":"2/3","setting":"Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer（UPGRADE-TNBC）","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2025-07-21","startedType":"actual","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07819591","kind":"trial","name":"Paclitaxel Polymeric Micelles Plus Ivonescimab in Recurrent or Refractory SCLC","aka":[],"tldr":"A phase 2 trial of ivonescimab in lung cancer, run by Shaodong Hong, not yet recruiting.","summary":"Paclitaxel Polymeric Micelles Plus Ivonescimab in Recurrent or Refractory SCLC is a phase 2, interventional study registered as NCT07819591 by Shaodong Hong, with a registry enrolment figure of 47 participants, started 2026-10-01 and due to reach its primary completion in 2028-12-01. Interventions recorded: Paclitaxel Polymeric Micelles; Ivonescimab. Conditions listed: SCLC, Recurrent. Primary outcome: Outcome Objective Response Rate (ORR) assessed by RECIST v1.1. Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed relapsed small-cell lung cancer after failure of platinum-based chemotherapy and PD-1/PD-L1 monoclonal antibody treatment\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07819591","url":"https://clinicaltrials.gov/study/NCT07819591"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["antiangiogenic","bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07819591","phase":"2","setting":"A Phase II Study of Paclitaxel Polymeric Micelles Combined With Ivonescimab in Patients With Recurrent or Refractory Small Cell Lung Cancer After Failure of Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Therapy","sponsor":"Shaodong Hong","started":"2026-10-01","startedType":"estimated","enrolled":47,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07033598","kind":"trial","name":"Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia","aka":["PROSPERA"],"tldr":"A phase 2 trial of Pacritinib in chronic myelomonocytic leukaemia and MDS/MPN overlap neoplasms, run by Theradex, now recruiting.","summary":"Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia is a phase 2 interventional study registered as NCT07033598 by Theradex, with 66 participants planned, started 2026-01-01 and due to reach its primary completion in 2028-07. Interventions recorded: Pacritinib and Hydroxyurea.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07033598","url":"https://clinicaltrials.gov/study/NCT07033598"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cmml"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["pacritinib"],"companies":["sobi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07033598","phase":"2","setting":"A Randomized Phase 2 Study of Pacritinib vs. Hydroxyurea in Patients With Advanced Proliferative Chronic Myelomonocytic Leukemia","sponsor":"Theradex","started":"2026-01-01","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"pakt","kind":"trial","name":"PAKT","aka":[],"tldr":"PAKT, a UK-led trial run from Barts, found that adding the AKT-blocking tablet capivasertib to paclitaxel lengthened life in metastatic triple-negative breast cancer (19 versus 13 months), most clearly in tumours with PI3K-pathway mutations. The much larger CAPItello-290 trial then found no survival gain.","summary":"PAKT (NCT02423603) was a double-blind, placebo-controlled randomised phase 2 trial sponsored by Queen Mary University of London with AstraZeneca and Cancer Research UK, which randomised 140 women with untreated metastatic triple-negative breast cancer 1 to 1 to paclitaxel 90 mg/m2 on days 1, 8 and 15 with capivasertib 400 mg or placebo twice daily on days 2 to 5, 9 to 12 and 16 to 19 of 28. Median progression-free survival was 5.9 versus 4.2 months (hazard ratio 0.74, 95 percent confidence interval 0.50 to 1.08, one-sided p 0.06 against a predefined level of 0.10) and median overall survival 19.1 versus 12.6 months (hazard ratio 0.61, 0.37 to 0.99, p 0.04). In the 28 patients with PIK3CA, AKT1 or PTEN-altered tumours median progression-free survival was 9.3 versus 3.7 months (hazard ratio 0.30, 0.11 to 0.79). Grade 3 or higher diarrhoea was 13 versus 1 percent. The trial recruited at 30 UK hospitals from Bangor and Belfast to the Royal Marsden and set up CAPItello-290, the 812-patient phase 3 with the same regimen, which in 2026 reported no overall survival difference in either the overall or the pathway-altered population.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02423603","url":"https://clinicaltrials.gov/study/NCT02423603"},{"label":"Schmid et al., JCO 2020: capivasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic TNBC, the PAKT trial","url":"https://doi.org/10.1200/JCO.19.00368"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["pi3k-akt-mtor-inhibitors","cytotoxic-chemotherapy"],"targets":["akt","pik3ca","pten"],"drugs":["capivasertib","paclitaxel"],"companies":["astrazeneca"],"institutions":["cruk"],"pathways":["pi3k-akt-mtor"],"terms":[],"trials":["nct03997123","lotus","ipatunity130"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 30): Bangor, Belfast, Bodelwyddan, Brighton, Cambridge, Canterbury, Cardiff (Velindre), Coventry, Edinburgh, Gillingham, Glasgow (Beatson), Leeds, London (Barts, University College London Hospitals, Barking Havering and Redbridge, Guy's and St Thomas', Lewisham and Greenwich, Royal Marsden) and others."],"nct":"NCT02423603","phase":"2","setting":"Untreated metastatic triple-negative breast cancer: first-line paclitaxel with capivasertib or placebo, UK-led academic phase 2 at 30 UK hospitals and sites in France, Georgia, Hungary, Romania and South Korea","sponsor":"Queen Mary University of London, with AstraZeneca and Cancer Research UK","result":"PFS 5.9 vs 4.2 months (HR 0.74); OS 19.1 vs 12.6 months (HR 0.61, p 0.04); PIK3CA/AKT1/PTEN-altered PFS 9.3 vs 3.7 months (HR 0.30). Not confirmed by CAPItello-290.","started":"2014-05-14","startedType":"actual","yearReported":2020,"enrolled":140,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 71 participants (actual) for the UK registration; the JCO 2020 paper reports 140 patients randomised across the six countries.","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Capivasertib + paclitaxel","n":70,"value":5.9},{"name":"Placebo + paclitaxel","n":70,"value":4.2}],"hr":0.74,"ci":[0.5,1.08],"p":"0.06 (one-sided; predefined level 0.10)","source":"https://doi.org/10.1200/JCO.19.00368"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Capivasertib + paclitaxel","value":19.1},{"name":"Placebo + paclitaxel","value":12.6}],"hr":0.61,"ci":[0.37,0.99],"p":"0.04","source":"https://doi.org/10.1200/JCO.19.00368"},{"endpoint":"Progression-free survival, PIK3CA/AKT1/PTEN-altered tumours","unit":"months","arms":[{"name":"Capivasertib + paclitaxel","value":9.3},{"name":"Placebo + paclitaxel","value":3.7}],"hr":0.3,"ci":[0.11,0.79],"p":"0.01","source":"https://doi.org/10.1200/JCO.19.00368"}],"replication":"Not replicated: CAPItello-290 (812 patients) found overall survival 17.7 vs 18.0 months overall and 20.4 vs 20.4 months in pathway-altered tumours."},{"id":"nct07085767","kind":"trial","name":"Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer","aka":["OPERA-02"],"tldr":"A phase 3 trial of Ribociclib in HR-positive / HER2-negative breast cancer, run by Olema Pharmaceuticals, Inc., now recruiting.","summary":"Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer is a phase 3 interventional study registered as NCT07085767 by Olema Pharmaceuticals, Inc., with 1000 participants planned, started 2025-11-03 and due to reach its primary completion in 2028-12. Interventions recorded: Palazestrant, Letrozole-matching placebo, Ribociclib, Letrozole and Palazestrant matching-placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07085767","url":"https://clinicaltrials.gov/study/NCT07085767"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["ribociclib"],"companies":["olema-pharmaceuticals","novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07085767","phase":"3","setting":"A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)","sponsor":"Olema Pharmaceuticals, Inc.","started":"2025-11-03","startedType":"actual","enrolled":1000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00101582","kind":"trial","name":"Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer","aka":[],"tldr":"A phase 3 trial of Palifermin in Head and neck squamous cell carcinoma, run by Swedish Orphan Biovitrum, completed.","summary":"Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer is a phase 3 interventional study registered as NCT00101582 by Swedish Orphan Biovitrum, with 188 participants recorded, started 2005-08 and reaching its primary completion in 2007-09. Interventions recorded: Placebo, palifermin, cisplatin chemotherapy, Radiotherapy. Conditions recorded: Mucositis, Solid Tumors, Stomatitis, Head and Neck Cancer, Squamous Cell Carcinoma.\n\nLinked to the drug Palifermin because the registry names it among its interventions and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00101582","url":"https://clinicaltrials.gov/study/NCT00101582"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":["palifermin"],"companies":["sobi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00101582","phase":"3","setting":"Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Radiotherapy With Concurrent Chemotherapy (RT/CT)","sponsor":"Swedish Orphan Biovitrum","started":"2005-08","yearReported":2014,"enrolled":188,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Severe (Grade 3 or 4) Oral Mucositis, Yes","primary":true,"unit":"participants","arms":[{"name":"Placebo","n":94,"value":62,"note":"Figures from the ClinicalTrials.gov results section (first posted 2014-09-15), not from a publication"},{"name":"Palifermin","n":94,"value":51}],"p":"0.0410","source":"https://clinicaltrials.gov/study/NCT00101582?tab=results"}]},{"id":"nct00109031","kind":"trial","name":"Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)","aka":[],"tldr":"A phase 3 trial of Palifermin, Cyclophosphamide and Etoposide in Leukaemia, run by Swedish Orphan Biovitrum, completed.","summary":"Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE) is a phase 3 interventional study registered as NCT00109031 by Swedish Orphan Biovitrum, with 47 participants recorded, started 2005-01 and reaching its primary completion in 2006-02. Interventions recorded: palifermin, Total Body Irradiation, Cyclophosphamide, Etoposide, Placebo. Conditions recorded: Cancer, Lymphoma, Leukemia.\n\nLinked to the drug Palifermin because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00109031","url":"https://clinicaltrials.gov/study/NCT00109031"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["palifermin","cyclophosphamide","etoposide"],"companies":["sobi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00109031","phase":"3","setting":"A Randomized, Blinded, Active-control Trial of Palifermin (rHuKGF) to Evaluate Oral Mucositis in Subjects With Hematologic Malignancies Undergoing Fractionated Total Body Irradiation (fTBI) and High Dose Chemotherapy With Autologous Peripheral Blood Progenitor Cell (PBPC) Transplantation","sponsor":"Swedish Orphan Biovitrum","started":"2005-01","yearReported":2014,"enrolled":47,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4), Yes","primary":true,"unit":"participants","arms":[{"name":"Palifermin 60 µg/kg for 3 Days","n":11,"value":9,"note":"Figures from the ClinicalTrials.gov results section (first posted 2014-09-15), not from a publication"},{"name":"Palifermin 180 μg/kg on Day -1","n":10,"value":6},{"name":"Palifermin 180 μg/kg on Day -2","n":13,"value":4},{"name":"Palifermin 180 μg/kg on Day -3","n":12,"value":9}],"source":"https://clinicaltrials.gov/study/NCT00109031?tab=results"}]},{"id":"pallas-penelope-b","kind":"trial","name":"PALLAS & PENELOPE-B","aka":[],"tldr":"Two large trials found that adding palbociclib after surgery does not prevent recurrence, even though the same drug helps in metastatic disease.","summary":"PALLAS and PENELOPE-B, led by trial NCT02513394 and sponsored by ABCSG, the Alliance, the German Breast Group and Pfizer, were two large trials reported in 2020 that found adding palbociclib after surgery does not prevent recurrence in HR-positive, HER2-negative early breast cancer, even though the same drug helps in metastatic disease. PALLAS gave two years of palbociclib with endocrine therapy to 5,796 women and PENELOPE-B gave one year to 1,250 women with residual disease after neoadjuvant chemotherapy, and neither improved invasive disease-free survival, with no survival difference at PENELOPE-B's final analysis. OnCo links them to CDK4/6 as a target, palbociclib, Miguel Martín and the Austrian Breast and Colorectal Cancer Study Group. Whether duration, dose intensity or drug differences explain the split is the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02513394","url":"https://clinicaltrials.gov/study/NCT02513394"}],"tags":["failure","lesson:drug-not-class"],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":["cdk4-6"],"drugs":["palbociclib"],"companies":["abcsg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["miguel-martin"],"bottlenecks":[],"keyPapers":["paper-pallas-penelope-b-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02513394","phase":"3","setting":"Adjuvant palbociclib + endocrine therapy in HR+/HER2- early breast cancer (PALLAS, 2 years; PENELOPE-B, 1 year after residual disease)","sponsor":"ABCSG / Alliance / GBG / Pfizer","result":"PALLAS iDFS HR 0.96; PENELOPE-B iDFS HR 0.93; both null.","started":"2015-08","yearReported":2020,"enrolled":6862,"enrolledBasis":"registry","outcomes":[{"endpoint":"4-year invasive disease-free survival (PALLAS)","primary":true,"unit":"%","arms":[{"name":"Palbociclib + ET","value":84.2},{"name":"ET alone","value":84.5}],"hr":0.96,"ci":[0.81,1.14],"source":"https://ascopost.com/issues/december-25-2021/final-analysis-of-pallas-trial-no-benefit-of-adjuvant-palbociclib-plus-endocrine-therapy-in-early-breast-cancer/"}],"replication":"Two independent null trials; the positive adjuvant trials used different CDK4/6 inhibitors (monarchE, NATALEE)."},{"id":"nct00002893","kind":"trial","name":"Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer","aka":[],"tldr":"A phase 3 trial of Fluorouracil, Leucovorin and Raltitrexed in Colorectal cancer, run by Medical Research Council, with a status the registry has not verified recently.","summary":"Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer is a phase 3 interventional study registered as NCT00002893 by Medical Research Council, with 900 participants planned, started 1995-06. Interventions recorded: fluorouracil, leucovorin calcium, raltitrexed. Conditions recorded: Colorectal Cancer.\n\nLinked to the drug Raltitrexed because the registry names it among its interventions and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00002893","url":"https://clinicaltrials.gov/study/NCT00002893"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["fluorouracil","leucovorin","raltitrexed"],"companies":["mrc-ctu"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002893","phase":"3","setting":"CHEMOTHERAPY CHOICES IN ADVANCED COLORECTAL CANCER: A RANDOMISED TRIAL COMPARING 2 DURATIONS AND 3 SYSTEMIC CHEMOTHERAPY REGIMENS IN THE PALLIATIVE TREATMENT OF ADVANCED COLORECTAL CANCER","sponsor":"Medical Research Council","started":"1995-06","enrolled":900,"enrolledBasis":"registry","outcomes":[]},{"id":"paloma-2","kind":"trial","name":"PALOMA-2","aka":[],"tldr":"The trial that made palbociclib the first CDK4/6 inhibitor in routine use. It doubled progression-free time but did not extend life.","summary":"PALOMA-2, trial NCT01740427 sponsored by Pfizer and reported in 2016, is the trial that made palbociclib the first CDK4/6 inhibitor in routine use: added to letrozole as first-line treatment for postmenopausal HR-positive, HER2-negative advanced breast cancer it doubled progression-free time but did not extend life. It randomised 666 women, met its primary progression-free survival endpoint, and at the final analysis showed no significant overall survival benefit, with substantial missing survival data; with PALOMA-3 this differentiates palbociclib from ribociclib and abemaciclib on survival. OnCo links it to CDK4/6 as a target, palbociclib, aromatase inhibitors and Richard S. Finn, and the absence of a survival benefit was replicated in PALOMA-3 and the adjuvant PALLAS and PENELOPE-B trials. Whether the three drugs truly differ or the trials did is the open question.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01740427","url":"https://clinicaltrials.gov/study/NCT01740427"}],"tags":[],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":["cdk4-6"],"drugs":["palbociclib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["richard-finn"],"bottlenecks":[],"keyPapers":["paper-paloma-2-n-engl-j-med-2016","paper-paloma-2-breast-cancer-res-treat-2019-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01740427","phase":"3","setting":"First-line postmenopausal HR+/HER2- advanced breast cancer: palbociclib + letrozole vs placebo + letrozole","sponsor":"Pfizer","result":"PFS HR 0.56; OS HR 0.96 (NS).","started":"2013-02-22","startedType":"actual","yearReported":2016,"enrolled":666,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Palbociclib + letrozole","n":444,"value":27.6},{"name":"Placebo + letrozole","n":222,"value":14.5}],"hr":0.56,"ci":[0.46,0.69],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1607303"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Palbociclib + letrozole","value":53.9},{"name":"Placebo + letrozole","value":51.2}],"hr":0.96,"ci":[0.78,1.18],"source":"https://doi.org/10.1056/NEJMoa1607303"}],"replication":"PFS effect replicated across all CDK4/6 trials; absence of OS benefit replicated in PALOMA-3 and the adjuvant PALLAS/PENELOPE-B trials."},{"id":"nct00376883","kind":"trial","name":"Pamidronate Prophylaxis in Multiple Myeloma 30 mg/Month Versus 90 mg/Month","aka":[],"tldr":"A phase 3 trial of Pamidronate in Multiple myeloma, run by Nordic Myeloma Study Group, completed.","summary":"Pamidronate Prophylaxis in Multiple Myeloma 30 mg/Month Versus 90 mg/Month is a phase 3 interventional study registered as NCT00376883 by Nordic Myeloma Study Group, with 500 participants recorded, started 2000-01. Interventions recorded: pamidronate. Conditions recorded: Multiple Myeloma.\n\nLinked to the drug Pamidronate because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00376883","url":"https://clinicaltrials.gov/study/NCT00376883"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["pamidronate"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00376883","phase":"3","setting":"The Effect of i.v. Bisphosphonate on Health-Related Quality of Life and Skeletal Morbidity for Newly Diagnosed Treatment Demanding Multiple Myeloma. A Prospective Randomised Double Blinded Dose-Effective Study With Cost-Utility Analysis.","sponsor":"Nordic Myeloma Study Group","started":"2000-01","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03899155","kind":"trial","name":"Pan Tumor Rollover Study","aka":[],"tldr":"A phase 2 trial of Nivolumab, Ipilimumab, Cabozantinib, Trametinib, Capecitabine and Bevacizumab in advanced solid tumours, run by Bristol-Myers Squibb, now recruiting.","summary":"Pan Tumor Rollover Study is a phase 2 interventional study registered as NCT03899155 by Bristol-Myers Squibb, with 1500 participants planned, started 2019-08-09 and due to reach its primary completion in 2029-08-25. Interventions recorded: Nivolumab, Ipilimumab, Cabozantinib, Trametinib, Relatlimab and Nivolumab + Relatlimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03899155","url":"https://clinicaltrials.gov/study/NCT03899155"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab","cabozantinib","trametinib","capecitabine","bevacizumab"],"companies":["bms","exelixis","novartis","clovis-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03899155","phase":"2","setting":"Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies","sponsor":"Bristol-Myers Squibb","started":"2019-08-09","startedType":"actual","enrolled":1500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03322995","kind":"trial","name":"Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial","aka":["PANC"],"tldr":"A phase 2 trial in pancreatic cancer, run by Medical College of Wisconsin, now recruiting.","summary":"Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial is a phase 2, interventional study registered as NCT03322995 by Medical College of Wisconsin, with a registry enrolment figure of 125 participants, started 2018-06-21 and due to reach its primary completion in 2027-06-01. Interventions recorded: First-line Chemotherapy; Second-line Chemotherapy; Chemoradiation. Conditions listed: Pancreatic Cancer. Primary outcome: Completion of all intended neoadjuvant therapy and surgical therapy. Pancreatic eligibility wording from the registry: \"* Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03322995","url":"https://clinicaltrials.gov/study/NCT03322995"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03322995","phase":"2","setting":"Adaptive Modification of Neoadjuvant Therapy Based on Clinical Response in Patients With Localized Pancreatic Cancer","sponsor":"Medical College of Wisconsin","started":"2018-06-21","startedType":"actual","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07098598","kind":"trial","name":"Pancreatic Cancer Diagnosis With FAPI-PET Imaging","aka":[],"tldr":"A phase 2/3 trial in pancreatic cancer, run by Turku University Hospital, now recruiting.","summary":"Pancreatic Cancer Diagnosis With FAPI-PET Imaging is a phase 2/3, interventional study registered as NCT07098598 by Turku University Hospital, with a registry enrolment figure of 100 participants, started 2024-10-09 and due to reach its primary completion in 2026-10. Interventions recorded: PET/CT. Conditions listed: Positron Emission Tomography; Pancreatic Cancer; FAPI; Diagnostics; Recurrent Pancreatic Cancer; Oncologic Surgery; Imaging, Diagnostic; Staging. Primary outcome: 1) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of local lymph node metastasis in patient level in patients with primary pancreatic cancer; 2) To assess the sensitivity and specificity 18F-FAPI-74 PET/CT in detection of distant metastasis in patient level in patients . Pancreatic eligibility wording from the registry: \"* Suspected primary or recurrent pancreatic cancer\". Sites: Finland. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07098598","url":"https://clinicaltrials.gov/study/NCT07098598"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07098598","phase":"2/3","setting":"Diagnostic Efficacy of 18F-FAPI-74 PET/CT in Patients With Pancreatic Cancer","sponsor":"Turku University Hospital","started":"2024-10-09","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07230509","kind":"trial","name":"Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate","aka":["NBCA"],"tldr":"A phase 2 trial in pancreatic cancer, run by Minia University, now recruiting.","summary":"Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate is a phase 2, randomised interventional study registered as NCT07230509 by Minia University, with a registry enrolment figure of 90 participants, started 2025-12-01 and due to reach its primary completion in 2027-12-01. Interventions recorded: Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group.; Standard Pancreaticojejunostomy. Conditions listed: Pancreaticoduodenectomy; Postoperative Pancreatic Fistula; Pancreas Cancer; Periampullary Cancer. Primary outcome: Incidence of postoperative pancreatic fistula. Pancreatic eligibility wording from the registry: \"* Patients undergoing pancreaticoduodenectomy for malignant lesions meeting the curative treatment intent in accordance with clinical guidelines\". Sites: Egypt. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07230509","url":"https://clinicaltrials.gov/study/NCT07230509"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07230509","phase":"2","setting":"Efficacy of Pancreatic Parenchymal N-Butyl-2-Cyanoacrylate Injection in Pancreaticojejunostomy After Pancreaticoduodenectomy: A Randomized Controlled Trial","sponsor":"Minia University","started":"2025-12-01","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"panfire-2","kind":"trial","name":"PANFIRE-2","aka":["PANFIRE 2","PANFIRE-II"],"tldr":"PANFIRE-2 treated 50 people with electric-pulse ablation of pancreatic tumours that could not be removed; they lived a median 17 months from diagnosis, longer than the trial's historical target, but more than half had complications and nearly half relapsed locally, so the treatment stays in specialist centres and trials.","summary":"Fifty participants (median age 61) were treated between December 2012 and September 2017. Median overall survival was 17 months from diagnosis of locally advanced disease (95 percent confidence interval 15 to 19) and 10 months from electroporation, the same 17 months whether patients had received FOLFIRINOX (22) or gemcitabine-based or no induction (18); for local recurrence it was 16 months from recurrence. Local recurrence after electroporation developed in 23 of 50 (46 percent); tumour volume of 37 cm3 or more, CA 19-9 of 2,000 U/mL or more and a fall of 50 percent or less after ablation predicted worse survival. There were 14 minor and 21 major complications in 29 participants (58 percent) and two deaths within 90 days, one probably related. The earlier phase 1/2 PANFIRE (25 patients) had reported 11 months from ablation and major complications in 10 patients. CROSSFIRE then found electroporation equivalent to stereotactic radiotherapy; NCCN lists irreversible electroporation as an option in experienced centres and the UK LAP-PIE study tested feasibility of a trial after chemotherapy.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01939665","url":"https://clinicaltrials.gov/study/NCT01939665"},{"label":"Ruarus et al., PANFIRE-2 (Radiology 2020)","url":"https://doi.org/10.1148/radiol.2019191109"},{"label":"Scheffer et al., PANFIRE phase 1/2 (Radiology 2017)","url":"https://doi.org/10.1148/radiol.2016152835"}],"tags":[],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":["irreversible-electroporation"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["ca19-9"],"trials":["crossfire"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01939665","phase":"2","setting":"Locally advanced pancreatic cancer (40 patients) or local recurrence after resection (10) at Dutch centres: percutaneous CT-guided irreversible electroporation after induction chemotherapy where given, a single-arm phase 2 with median overall survival from diagnosis as the primary endpoint","sponsor":"Amsterdam University Medical Centre","result":"Median overall survival 17 months from diagnosis (95 percent confidence interval 15 to 19) and 10 months from electroporation in locally advanced disease; local recurrence 46 percent; major complications in 21 events across 29 of 50 participants.","started":"2013-09","startedType":"actual","yearReported":2020,"enrolled":50,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival from diagnosis, locally advanced cohort","primary":true,"unit":"months","arms":[{"name":"Percutaneous irreversible electroporation","n":40,"value":17,"note":"95% CI 15 to 19; target 11.6 to 14.9 months"}],"source":"https://doi.org/10.1148/radiol.2019191109"}]},{"id":"nct03384238","kind":"trial","name":"Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery","aka":[],"tldr":"A phase 1/2 trial of panitumumab in pancreatic cancer, run by George Poultsides, now recruiting.","summary":"Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery is a phase 1/2, interventional study registered as NCT03384238 by George Poultsides, with a registry enrolment figure of 27 participants, started 2018-02-07 and due to reach its primary completion in 2027-03. Interventions recorded: Fluorescence Imaging; Panitumumab; Panitumumab-IRDye800. Conditions listed: Pancreatic Adenocarcinoma. Primary outcome: Tumor to background ratio (TBR). Pancreatic eligibility wording from the registry: \"* Clinically suspected or biopsy-confirmed diagnosis of pancreatic adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03384238","url":"https://clinicaltrials.gov/study/NCT03384238"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["panitumumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03384238","phase":"1/2","setting":"A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Pancreas Cancer During Surgical Procedures","sponsor":"George Poultsides","started":"2018-02-07","startedType":"actual","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07043907","kind":"trial","name":"PANK-003 Cell Injection Combined With Standard Adjuvant Chemotherapy After Surgery in Patients With Stage IIIA NSCLC","aka":["PANK-003"],"tldr":"A phase 2 trial in lung cancer, run by Shenzhen Celconta Life Science Co., Ltd., not yet recruiting.","summary":"PANK-003 Cell Injection Combined With Standard Adjuvant Chemotherapy After Surgery in Patients With Stage IIIA NSCLC is a phase 2, interventional study registered as NCT07043907 by Shenzhen Celconta Life Science Co., Ltd., with a registry enrolment figure of 115 participants, started 2025-07-08 and due to reach its primary completion in 2028-07-08. Interventions recorded: PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy. Conditions listed: Stage IIIA Non-small Cell Lung Cancer. Primary outcome: Incidence and severity of adverse events (AEs); Disease Free Surviva Percentage（DFS%）. Lung eligibility wording from the registry: \"Patients with histologically confirmed stage IIIA NSCLC (T4N0M0, T3-4N1M0, T1a-2bN2M0) who underwent R0 resection and received postoperative adjuvant chemotherapy (Exclusion of EGFR sensitizing mutations and ALK fusion); and who received the first dose of PANK-003 cell injection combined with postop\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07043907","url":"https://clinicaltrials.gov/study/NCT07043907"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07043907","phase":"2","setting":"A Single-center, Single-arm Exploratory Clinical Trial on the Safety and Efficacy of PANK-003 Cell Injection Combined With Standard Adjuvant Chemotherapy After Surgery in Patients With Stage IIIA Non-Small Cell Lung Cancer","sponsor":"Shenzhen Celconta Life Science Co., Ltd.","started":"2025-07-08","startedType":"estimated","enrolled":115,"enrolledBasis":"registry","outcomes":[]},{"id":"panku-esophagus01","kind":"trial","name":"PANKU-Esophagus01 (BL-B01D1-305)","aka":[],"tldr":"The first bispecific ADC to extend both progression-free and overall survival in oesophageal cancer, for patients whose immunotherapy has stopped working.","summary":"Interim analysis met dual primary endpoints of OS and BICR-assessed PFS (announced February 2026; presented ASCO 2026). 249 vs 248 patients. Second-line ESCC previously had only single-agent chemotherapy (irinotecan, taxanes) with median OS under a year. Global confirmatory trials are being planned.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06304974","url":"https://clinicaltrials.gov/study/NCT06304974"},{"label":"Announcement","url":"https://www.biospace.com/press-releases/izalontamab-brengitecan-iza-bren-demonstrates-statistically-significant-and-clinically-meaningful-improvements-in-overall-survival-and-progression-free-survival-in-patients-with-triple-negative-breast-cancer-and-esophageal-squamous-cell-carcinoma"}],"tags":[],"related":[],"cancers":["esophageal"],"sections":[],"technologies":["bispecific-adc"],"targets":["egfr","her3"],"drugs":["izalontamab-brengitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["bl-b01d1-307"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06304974","phase":"3","setting":"Recurrent or metastatic oesophageal squamous cell carcinoma after PD-(L)1 inhibitor plus platinum chemotherapy: izalontamab brengitecan vs chemotherapy of physician's choice","sponsor":"SystImmune / BMS","result":"OS and PFS significantly improved at interim analysis; numbers per ASCO 2026 presentation.","started":"2024-03-19","startedType":"actual","yearReported":2026,"enrolled":497,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Izalontamab brengitecan","value":9.8},{"name":"Chemotherapy (physician's choice)","value":7.2}],"hr":0.64,"ci":[0.49,0.83],"p":"0.0004","source":"https://www.prnewswire.com/news-releases/systimmune-announces-second-approval-of-iza-bren-in-china-for-the-treatment-of-recurrent-or-metastatic-esophageal-squamous-cell-carcinoma-302827983.html"},{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Izalontamab brengitecan","value":4.2},{"name":"Chemotherapy (physician's choice)","value":2}],"hr":0.5,"ci":[0.4,0.63],"p":"<0.0001","source":"https://www.prnewswire.com/news-releases/systimmune-announces-second-approval-of-iza-bren-in-china-for-the-treatment-of-recurrent-or-metastatic-esophageal-squamous-cell-carcinoma-302827983.html"}],"replication":"Single Chinese phase 3 (ASCO 2026 oral; NMPA approval July 2026); consistent with the positive iza-bren phase 3s in nasopharyngeal carcinoma and TNBC (BL-B01D1-307). No data outside China yet."},{"id":"nct02506959","kind":"trial","name":"Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma","aka":[],"tldr":"A phase 2 trial of Busulfan, Gemcitabine, Melphalan and Panobinostat in Plasma cell leukaemia, run by M.D. Anderson Cancer Center, completed.","summary":"Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma is a phase 2 interventional study registered as NCT02506959 by M.D. Anderson Cancer Center, with 83 participants recorded, started 2015-09-14 and reaching its primary completion in 2024-06-03. Interventions recorded: Autologous Hematopoietic Stem Cell Transplantation, Busulfan, Gemcitabine Hydrochloride, Melphalan, Panobinostat, Peripheral Blood Stem Cell Transplantation, Pharmacological Study. Conditions recorded: Plasma Cell Leukemia, Plasmacytoma, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma.\n\nLinked to the drug Panobinostat because the registry names it among its interventions and Plasma cell leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02506959","url":"https://clinicaltrials.gov/study/NCT02506959"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["plasma-cell-leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["busulfan","gemcitabine","melphalan","panobinostat"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02506959","phase":"2","setting":"Panobinostat Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Myeloma","sponsor":"M.D. Anderson Cancer Center","started":"2015-09-14","startedType":"actual","yearReported":2025,"enrolled":83,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"participants","arms":[{"name":"Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel","n":50,"value":38,"note":"Figures from the ClinicalTrials.gov results section (first posted 2025-03-18), not from a publication"},{"name":"Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel","n":33,"value":24}],"source":"https://clinicaltrials.gov/study/NCT02506959?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"participants","arms":[{"name":"Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel","n":50,"value":27,"note":"Figures from the ClinicalTrials.gov results section (first posted 2025-03-18), not from a publication"},{"name":"Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel","n":33,"value":16}],"source":"https://clinicaltrials.gov/study/NCT02506959?tab=results"}]},{"id":"panoptimox-prodige-35","kind":"trial","name":"PANOPTIMOX-PRODIGE 35","aka":["PRODIGE 35","PANOPTIMOX"],"tldr":"PANOPTIMOX showed that people whose pancreatic cancer is controlled after four months of FOLFIRINOX can drop to a gentler fluorouracil maintenance without losing survival, living longer before their quality of life fell; the alternating gemcitabine strategy did worse.","summary":"PANOPTIMOX-PRODIGE 35 randomised 276 patients (mean age 63) between January 2015 and November 2016: arm A six months of FOLFIRINOX (91), arm B four months of FOLFIRINOX then leucovorin plus fluorouracil maintenance in controlled patients (92), arm C sequential gemcitabine and FOLFIRI.3 alternating every two months (90). Six-month progression-free survival was 47.1, 42.9 and 34.1 percent and median overall survival 10.1, 11.2 and 7.3 months. Median survival without deterioration in quality-of-life scores was 11.4 months in the maintenance arm against 7.2 and 7.5 months, but grade 3 or 4 neurotoxicity was higher with maintenance (19.8 against 10.2 percent), probably because more oxaliplatin was delivered (92 against 83 percent of the target dose). The maintenance strategy became an accepted way to give FOLFIRINOX and the platform on which POLO-style maintenance questions sit for patients without a BRCA mutation.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02352337","url":"https://clinicaltrials.gov/study/NCT02352337"},{"label":"Dahan et al., PANOPTIMOX-PRODIGE 35 (JCO 2021)","url":"https://doi.org/10.1200/JCO.20.03329"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["folfirinox","fluorouracil","leucovorin","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":["maintenance-therapy","quality-of-life","peripheral-neuropathy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02352337","phase":"2","setting":"Untreated metastatic pancreatic cancer in France: six months of FOLFIRINOX, against four months of FOLFIRINOX then leucovorin and fluorouracil maintenance with oxaliplatin reintroduced on progression, against alternating gemcitabine and FOLFIRI.3 every two months, with six-month progression-free survival as the primary endpoint","sponsor":"Federation Francophone de Cancerologie Digestive (FFCD)","result":"Six-month progression-free survival 47.1 percent (six months of FOLFIRINOX), 42.9 percent (four months then fluorouracil maintenance) and 34.1 percent (alternating gemcitabine and FOLFIRI.3); median overall survival 10.1, 11.2 and 7.3 months.","started":"2015-01-12","startedType":"actual","yearReported":2021,"enrolled":276,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 6 months","primary":true,"unit":"%","arms":[{"name":"FOLFIRINOX 6 months","n":91,"value":47.1},{"name":"FOLFIRINOX 4 months then LV5FU2 maintenance","n":92,"value":42.9},{"name":"Alternating gemcitabine and FOLFIRI.3","n":90,"value":34.1}],"source":"https://doi.org/10.1200/JCO.20.03329"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"FOLFIRINOX 6 months","value":10.1},{"name":"FOLFIRINOX 4 months then LV5FU2 maintenance","value":11.2},{"name":"Alternating gemcitabine and FOLFIRI.3","value":7.3}],"source":"https://doi.org/10.1200/JCO.20.03329"}]},{"id":"nct07028424","kind":"trial","name":"PANORAMIX : Optimizing 1st-line NALIRIFOX and Exploring Microbiota's Role in 2nd Line Pancreatic Cancer Treatment","aka":["PANORAMIX"],"tldr":"A phase 2 trial of liposomal irinotecan, paclitaxel / nab-paclitaxel, gemcitabine, cAPOX (capecitabine, oxaliplatin) and other drugs in pancreatic cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group, not yet recruiting.","summary":"PANORAMIX : Optimizing 1st-line NALIRIFOX and Exploring Microbiota's Role in 2nd Line Pancreatic Cancer Treatment is a phase 2, randomised interventional study registered as NCT07028424 by GERCOR - Multidisciplinary Oncology Cooperative Group, with a registry enrolment figure of 206 participants, started 2025-07 and due to reach its primary completion in 2029-07. Interventions recorded: Nal-IRI; Ciprofloxacin; Paclitaxel; Gemcitabine; Oxaliplatin; Leucovorin; 5-Fluorouracil; Placebo. Conditions listed: PDAC - Pancreatic Ductal Adenocarcinoma. Primary outcome: 6-month progression-free survival (PFS) rate post randomization Step 1 (R1) in Arm 1A. Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07028424","url":"https://clinicaltrials.gov/study/NCT07028424"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["liposomal-irinotecan","paclitaxel","gemcitabine","capox","flot","fluorouracil"],"companies":["gercor"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07028424","phase":"2","setting":"Pancreatic Cancer First-line NALIRIFOX Optimization With 5-FU Maintenance and Role of Antibiotics and Microbiota Exploration in Second-line Treatment - A Non-comparative, Randomized Phase II PANORAMIX GERCOR G-116 PRODIGE 105 Study.","sponsor":"GERCOR - Multidisciplinary Oncology Cooperative Group","started":"2025-07","startedType":"estimated","enrolled":206,"enrolledBasis":"registry","outcomes":[]},{"id":"panova-3","kind":"trial","name":"PANOVA-3","aka":[],"tldr":"PANOVA-3 is the trial behind the 2026 approval of a wearable electric-field device for pancreatic cancer, the first new approval in locally advanced disease in decades.","summary":"PANOVA-3, trial NCT03377491 sponsored by Novocure and reported in 2025, is the trial behind the 2026 approval of Optune Pax, a wearable electric-field device, for unresectable locally advanced pancreatic cancer, the first new approval in that setting in decades. It randomised 571 patients to tumour treating fields plus gemcitabine and nab-paclitaxel or chemotherapy alone, met its primary overall survival endpoint with a modest effect presented at the ASCO 2025 plenary, and also improved pain-free survival, leading to FDA approval in the first quarter of 2026. OnCo links it to pancreatic ductal adenocarcinoma, tumour treating fields, the Optune device record, gemcitabine plus nab-paclitaxel and Novocure. It is a single pivotal trial, and its open-label design and modest effect size are debated, so whether the device changes practice outside trial centres is the open question.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT03377491","url":"https://clinicaltrials.gov/study/NCT03377491"},{"label":"Babiker et al., PANOVA-3 (JCO 2025)","url":"https://doi.org/10.1200/JCO-25-00746"}],"tags":[],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":["ttfields"],"targets":[],"drugs":["optune","gemcitabine-nab-paclitaxel"],"companies":["novocure"],"institutions":[],"pathways":[],"terms":[],"trials":["mpact","lap07","conko-007"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Primary paper (JCO 2025): pain-free survival 15.2 against 9.1 months (hazard ratio 0.74; p 0.027) and distant progression-free survival 13.9 against 11.5 months (hazard ratio 0.74; p 0.022) improved; progression-free survival, local control and response did not; device-related skin adverse events 76.3 percent, grade 3 in 7.7 percent. No UK sites; results posted to the registry January 2026; no NICE appraisal on 24 September 2026."],"nct":"NCT03377491","phase":"3","setting":"Unresectable locally advanced PDAC: TTFields + gemcitabine/nab-paclitaxel vs chemotherapy alone","sponsor":"Novocure","result":"OS 16.2 vs 14.2 months, HR 0.82.","started":"2018-05-10","startedType":"actual","yearReported":2025,"enrolled":571,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"TTFields + gemcitabine/nab-paclitaxel","n":284,"value":16.2},{"name":"Gemcitabine/nab-paclitaxel","n":287,"value":14.2}],"hr":0.82,"ci":[0.68,0.99],"p":"0.039","source":"https://ascopubs.org/doi/10.1200/JCO.25.00361"},{"endpoint":"Pain-free survival","unit":"months","arms":[{"name":"TTFields + gemcitabine/nab-paclitaxel","value":15.2,"note":"95% CI 10.3 to 22.8"},{"name":"Gemcitabine/nab-paclitaxel","value":9.1,"note":"95% CI 7.4 to 12.7"}],"hr":0.74,"ci":[0.56,0.97],"p":"0.027","source":"https://doi.org/10.1200/JCO-25-00746"}],"replication":"Single pivotal trial; open-label design and modest effect size are debated."},{"id":"paola-1","kind":"trial","name":"PAOLA-1 / ENGOT-ov25","aka":[],"tldr":"Adding olaparib to bevacizumab maintenance roughly doubled progression-free time in tumours with faulty DNA repair, and improved survival in that group.","summary":"PFS 22.1 vs 16.6 months overall (HR 0.59) and 37.2 vs 17.7 months in HRD-positive tumours (HR 0.33; NEJM 2019). Five-year OS in HRD-positive patients was 65.5% vs 48.4% (HR 0.62; Annals of Oncology 2023). No benefit in HRD-negative disease. Approved in 2020 for HRD-positive tumours; it established HRD testing as a decision point.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02477644","url":"https://clinicaltrials.gov/study/NCT02477644"},{"label":"NEJM 2019","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1911361"}],"tags":[],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":["parp","brca","vegf"],"drugs":["olaparib","bevacizumab"],"companies":["arcagy-gineco"],"institutions":[],"pathways":[],"terms":["hrd"],"trials":[],"people":["isabelle-ray-coquard"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02477644","phase":"3","setting":"Newly diagnosed advanced ovarian cancer already on bevacizumab maintenance: adding olaparib vs placebo","sponsor":"ARCAGY-GINECO / AstraZeneca","result":"PFS HR 0.59 overall, 0.33 HRD-positive; 5-year OS 65.5% vs 48.4% in HRD-positive.","started":"2015-05-06","startedType":"actual","yearReported":2019,"enrolled":806,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (HRD-positive)","unit":"months","arms":[{"name":"Olaparib + bevacizumab","value":37.2},{"name":"Placebo + bevacizumab","value":17.7}],"hr":0.33,"ci":[0.25,0.45],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1911361"},{"endpoint":"Overall survival at 5 years (HRD-positive)","unit":"%","arms":[{"name":"Olaparib + bevacizumab","value":65.5},{"name":"Placebo + bevacizumab","value":48.4}],"hr":0.62,"ci":[0.45,0.85],"source":"https://www.annalsofoncology.org/article/S0923-7534(23)00658-0/fulltext"}]},{"id":"papmet","kind":"trial","name":"PAPMET (SWOG S1500)","aka":["PAPMET","S1500","SWOG S1500"],"tldr":"PAPMET was the first randomised trial dedicated to papillary kidney cancer; cabozantinib held the disease back for longer than sunitinib, the previous default, while two more selective MET inhibitors did not.","summary":"Papillary renal cell carcinoma had been treated with drugs developed for clear cell disease. PAPMET, a SWOG-led randomised phase 2 trial, assigned 152 patients with metastatic papillary renal cell carcinoma, untreated or after one prior therapy, to sunitinib or to one of three MET-directed inhibitors: cabozantinib, crizotinib or savolitinib. The primary endpoint was progression-free survival against sunitinib.\n\nThe crizotinib and savolitinib arms were closed early for futility. Cabozantinib lengthened progression-free survival and produced more responses than sunitinib, and became the preferred single agent for papillary disease in guidelines, later joined by immunotherapy combinations tested in single-arm studies.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02761057","url":"https://clinicaltrials.gov/study/NCT02761057"}],"tags":["subtype-trials"],"related":[],"cancers":["papillary-rcc","rcc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["cabozantinib","sunitinib","crizotinib","savolitinib"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sumanta-pal"],"bottlenecks":[],"keyPapers":["paper-papmet-pal-lancet-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02761057","phase":"2","setting":"Metastatic papillary renal cell carcinoma: sunitinib against cabozantinib, crizotinib or savolitinib","sponsor":"SWOG Cancer Research Network (National Cancer Institute)","result":"Cabozantinib lengthened progression-free survival compared with sunitinib in metastatic papillary renal cell carcinoma; the crizotinib and savolitinib arms closed for futility.","started":"2016-07-25","startedType":"actual","yearReported":2021,"enrolled":152,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Cabozantinib","n":44,"value":9},{"name":"Sunitinib","n":46,"value":5.6}],"hr":0.6,"ci":[0.37,0.97],"p":"0.019 (one-sided)","source":"https://doi.org/10.1016/S0140-6736(21)00152-5"},{"endpoint":"Response rate","unit":"%","arms":[{"name":"Cabozantinib","n":44,"value":23},{"name":"Sunitinib","n":46,"value":4}],"p":"0.010","source":"https://doi.org/10.1016/S0140-6736(21)00152-5"}]},{"id":"paradigm","kind":"trial","name":"PARADIGM","aka":[],"tldr":"Proved that for RAS-normal tumours starting on the left side of the colon, an EGFR antibody beats the VEGF antibody as first partner for chemotherapy.","summary":"Left-sided primaries: OS 37.9 vs 34.3 months (HR 0.82), the longest median OS in a first-line phase 3 at the time; no benefit in right-sided tumours. Confirmed the sidedness principle from FIRE-3 and CALGB 80405 subgroup analyses and made 'left-sided, RAS/BRAF wild-type' the anti-EGFR population in guidelines.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02394795","url":"https://clinicaltrials.gov/study/NCT02394795"},{"label":"ASCO 2022 plenary","url":"https://ascopubs.org/doi/10.1200/JCO.2022.40.17_suppl.LBA1"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["egfr","vegf"],"drugs":["panitumumab","bevacizumab","folfox"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":["sidedness"],"trials":["prime","calgb-80405","opus","cairo5"],"people":["yoshino-takayuki"],"bottlenecks":[],"keyPapers":["paper-arnold-primary-tumour-side-ras-wild-type-ann-oncol-2017","paper-douillard-prime-panitumumab-ras-nejm-2013","paper-paradigm-jama-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02394795","phase":"3","setting":"First-line RAS wild-type metastatic colorectal cancer: panitumumab + mFOLFOX6 vs bevacizumab + mFOLFOX6","sponsor":"Takeda (Japan)","result":"OS 37.9 vs 34.3 months (HR 0.82) in left-sided RAS wild-type disease.","started":"2015-05-29","startedType":"actual","yearReported":2022,"enrolled":823,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, left-sided","primary":true,"unit":"months","arms":[{"name":"Panitumumab + mFOLFOX6","value":37.9},{"name":"Bevacizumab + mFOLFOX6","value":34.3}],"hr":0.82,"ci":[0.68,0.99],"p":"0.031","source":"https://ascopubs.org/doi/10.1200/JCO.2022.40.17_suppl.LBA1"}],"replication":"Replicates FIRE-3 (cetuximab vs bevacizumab with FOLFIRI, OS benefit) and the CALGB/SWOG 80405 sidedness analysis."},{"id":"nct06533384","kind":"trial","name":"PARPi or Capecitabine Combined With PD-1 Inhibitors as Adjuvant Therapy in High-risk TNBC","aka":[],"tldr":"A phase 3 trial of capecitabine in triple-negative breast cancer, run by Guangdong Provincial People's Hospital, now recruiting.","summary":"PARPi or Capecitabine Combined With PD-1 Inhibitors as Adjuvant Therapy in High-risk TNBC is a phase 3, randomised interventional study registered as NCT06533384 by Guangdong Provincial People's Hospital, with a registry enrolment figure of 310 participants, started 2024-08-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: As per the germline BRCA1/2 mutation status, the selection of either Fuzuloparib or capecitabine in combination with Camrelizumab is made for adjuvant therapy.; 9 cycles of Camrelizumab as adjuvant therapy.. Conditions listed: Triple-negative Breast Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06533384","url":"https://clinicaltrials.gov/study/NCT06533384"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06533384","phase":"3","setting":"PARPi or Capecitabine Combined With PD-1 Inhibitors Was Selected Based on the Germline BRCA1/2 Mutation vs. PD-1 Inhibitors Alone as Adjuvant Therapy in High-risk Non-pCR TNBC","sponsor":"Guangdong Provincial People's Hospital","started":"2024-08-01","startedType":"actual","enrolled":310,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02215889","kind":"trial","name":"Partial Liver Segment 2/3 Transplantation Study","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by Oslo University Hospital, now recruiting.","summary":"Partial Liver Segment 2/3 Transplantation Study is a phase 1/2, interventional study registered as NCT02215889 by Oslo University Hospital, with a registry enrolment figure of 20 participants, started 2014-06 and due to reach its primary completion in 2025-06. Interventions recorded: Liver transplantation. Conditions listed: Colorectal Cancer. Primary outcome: Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation.. Colorectal eligibility wording from the registry: \"* Histologically verified adenocarcinoma in colon/rectum\". Sites: Norway. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02215889","url":"https://clinicaltrials.gov/study/NCT02215889"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02215889","phase":"1/2","setting":"A Phase I/II Clinical Trial to Evaluate the Benefit and Efficacy of Liver Resection And Partial Liver Segment 2/3 Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Liver Metastases From ColoRectal Carcinoma","sponsor":"Oslo University Hospital","started":"2014-06","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"partiqol","kind":"trial","name":"PARTIQoL","aka":[],"tldr":"The first multicentre randomised trial of protons versus IMRT for localised prostate cancer found no difference in bowel, urinary or sexual quality of life and the same cancer control at five years.","summary":"PARTIQoL (NCT01617161) randomised 450 men with low- or intermediate-risk localised prostate cancer at 29 centres between 2012 and 2021 to proton beam therapy or intensity-modulated photon radiotherapy, without hormone therapy, with the change in EPIC bowel quality of life at 24 months as the primary endpoint. It is one of the few adult proton-versus-photon trials able to test whether a distal LET and RBE difference near rectum and bladder is clinically real, and accrual was slow in a field where patients can obtain protons off-trial.\n\nReported as a late-breaking abstract at ASTRO 2024 with a median follow-up of 60.3 months: bowel scores fell only slightly in both arms (91.8 with protons and 91.9 with IMRT at 24 months, from 93.7 and 93.5 at baseline; p=0.836), with no differences in urinary incontinence, urinary irritation or sexual function at any time point and five-year progression-free survival of 93.4% with protons and 93.7% with IMRT (p=0.706). Neither technique beat the other, so the adult proton case in prostate cancer rests on other arguments than a wider therapeutic window.","status":"completed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01617161","url":"https://clinicaltrials.gov/study/NCT01617161"},{"label":"ASTRO 2024 late-breaking abstract (IJROBP)","url":"https://doi.org/10.1016/j.ijrobp.2024.08.012"},{"label":"PARTIQoL feasibility and baseline characteristics (International Journal of Radiation Oncology Biology Physics 2025)","url":"https://doi.org/10.1016/j.ijrobp.2024.09.043"}],"tags":["radiation-wave5"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["proton-therapy","imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":["mgh"],"pathways":[],"terms":["relative-biological-effectiveness","linear-energy-transfer","alpha-beta-ratio","bragg-peak","prostate-radiotherapy-fractionation"],"trials":["pace-b","chhip"],"people":[],"bottlenecks":[],"keyPapers":["paper-partiqol-astro-2024"],"journals":[],"dependsOn":[],"notes":["PARTIQoL randomised men with low-risk or intermediate-risk prostate cancer to proton beam therapy or photon-based intensity-modulated radiotherapy, stratified by institution, age, use of a rectal spacer and fractionation schedule (conventional 79.2 Gy in 44 fractions against moderately hypofractionated 70.0 Gy in 28 fractions). The primary endpoint is change from baseline in bowel health on the Expanded Prostate Index Composite at 24 months. Median age of the 437 analysed men was 68 (range 46 to 89); 41 percent had low-risk and 59 percent intermediate-risk disease; 49 percent had conventional and 51 percent moderately hypofractionated treatment; 48 percent used a rectal spacer; and among those having protons, 48 percent received pencil-beam scanning. The arms were balanced at baseline (International Journal of Radiation Oncology Biology Physics 2025).","The trial took nine years to accrue 450 men, and its authors published the feasibility experience deliberately, because payer engagement, multicentre collaboration and protocol updates to keep pace with technique were what made a randomised proton comparison possible at all. That is the transferable finding; the primary bowel-health result is reported separately."],"nct":"NCT01617161","phase":"3","setting":"Low- and intermediate-risk localised prostate cancer: proton beam therapy versus intensity-modulated photon radiotherapy","sponsor":"Massachusetts General Hospital","result":"No difference between protons and IMRT in EPIC bowel quality of life at 24 months (primary endpoint, p=0.836) or in urinary or sexual function; five-year progression-free survival 93.4% vs 93.7%.","started":"2012-07-25","startedType":"actual","yearReported":2024,"enrolled":450,"enrolledBasis":"randomised","enrolledNote":"450 men were accrued between July 2012 and November 2021, 226 to proton beam therapy and 224 to intensity-modulated radiotherapy; 13 were ineligible or withdrew before treatment, leaving 437 analysed.","outcomes":[{"endpoint":"EPIC bowel quality of life at 24 months","primary":true,"unit":"score (0-100)","arms":[{"name":"Proton beam therapy","value":91.8,"note":"Baseline 93.7"},{"name":"IMRT","value":91.9,"note":"Baseline 93.5"}],"p":"0.836","source":"https://doi.org/10.1016/j.ijrobp.2024.08.012"},{"endpoint":"Progression-free survival at 5 years","unit":"%","arms":[{"name":"Proton beam therapy","value":93.4},{"name":"IMRT","value":93.7}],"p":"0.706","source":"https://doi.org/10.1016/j.ijrobp.2024.08.012"}]},{"id":"partner","kind":"trial","name":"PARTNER","aka":["PARTNER trial","NCT03150576"],"tldr":"The Cambridge-led UK trial that added olaparib to neoadjuvant carboplatin and paclitaxel for triple-negative and BRCA breast cancer and found the 48-hour gap schedule gave 100 percent three-year survival in the germline BRCA group.","summary":"PARTNER is a randomised phase 2/3, three-stage trial sponsored by Cambridge University Hospitals and led by Jean Abraham, recruiting from NHS sites across England, Scotland and Wales (its ClinicalTrials.gov record listed 30 UK sites and a status of recruiting on 24 September 2026, with a registered enrolment of 780). It tested the addition of olaparib to platinum-based neoadjuvant chemotherapy in patients with triple-negative and/or germline BRCA breast cancer. The Nature 2024 paper and the University of Cambridge release report that in the germline BRCA group, 100 percent of the 39 patients given chemotherapy followed by olaparib after a 48-hour gap were alive at three years after surgery with one relapse, against 88 percent of the 45 control patients with nine relapses and six deaths.","status":"positive","asOf":"2026-09-24","links":[{"label":"Nature 2024 (DOI)","url":"https://doi.org/10.1038/s41586-024-07384-2"},{"label":"University of Cambridge news release","url":"https://www.cam.ac.uk/research/news/new-approach-to-treating-aggressive-breast-cancers-shows-significant-improvement-in-survival"},{"label":"Be Part of Research record","url":"https://bepartofresearch.nihr.ac.uk/trial-details/trial-detail?trialId=NCT03150576"},{"label":"ClinicalTrials.gov NCT03150576","url":"https://clinicaltrials.gov/study/NCT03150576"}],"tags":["uk","breast","neoadjuvant"],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["parp-inhibitor","platinum","cytotoxic-chemotherapy"],"targets":["brca"],"drugs":["olaparib","carboplatin","paclitaxel"],"companies":[],"institutions":["addenbrookes-cambridge","cruk-cambridge-centre"],"pathways":[],"terms":["pcr","gbrca-mutation"],"trials":["phoenix","brightness","keynote-522"],"people":["jean-abraham"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registry facts (24 September 2026): randomised three-stage phase 2/3 (NCT03150576) of olaparib added to neoadjuvant paclitaxel and carboplatin in triple-negative or germline BRCA breast cancer, sponsored by Cambridge University Hospitals with AstraZeneca and Cancer Research UK; 780 patients estimated; stage 3 primary endpoint pathological complete response by central review; status recruiting; 30 UK sites from Ayr and Kilmarnock to Swansea, Cardiff, Cambridge, Oxford, University College London Hospital and the Royal Free."],"nct":"NCT03150576","phase":"2/3","setting":"Neoadjuvant: olaparib added to platinum-based chemotherapy in triple-negative and/or germline BRCA early breast cancer, with the timing of olaparib after carboplatin tested","sponsor":"Cambridge University Hospitals NHS Foundation Trust","result":"Germline BRCA group: three-year survival 100 percent (39 patients, one relapse) with the gap schedule versus 88 percent (45 patients, nine relapses) with chemotherapy alone (University of Cambridge release on the Nature 2024 paper).","started":"2016-05","yearReported":2024,"enrolledBasis":"registry","outcomes":[]},{"id":"patch-transdermal-oestradiol","kind":"trial","name":"PATCH (Prostate Adenocarcinoma Transcutaneous Hormone)","aka":["PATCH","Prostate Adenocarcinoma Transcutaneous Hormone","transdermal oestradiol trial"],"tldr":"Oestrogen patches suppress testosterone as well as the standard injections, protect the bones instead of thinning them, and, contrary to what killed the idea in the 1970s, do not cause more heart attacks and strokes.","summary":"Oral oestrogens were abandoned as prostate cancer treatment because they caused fatal cardiovascular events. Transdermal oestradiol bypasses first-pass hepatic metabolism, and PATCH was designed to find out whether that removes the harm while keeping the benefit.\n\nBetween August 2007 and July 2019 PATCH randomly allocated 1,694 men at 52 UK sites, 790 to a luteinising hormone-releasing hormone agonist and 904 to oestradiol patches, with allocation 1:2 from 2007 and 1:1 from February 2011. Median follow-up was 3.9 years. Castration rates at 1 month and 3 months were 65 and 93 percent with the agonist and 83 and 93 percent with patches: the patches worked faster and equally well.\n\nOne hundred and fifty-seven cardiovascular events meeting predefined criteria occurred in 145 men, with ten further sudden deaths without a post-mortem report, 167 events in 153 men in total. Twenty-six of 1,694 men (2 percent) had a fatal cardiovascular event, 15 of 790 on the agonist and 11 of 904 on patches. Time to first cardiovascular event did not differ, hazard ratio 1.11 (95 percent confidence interval 0.80 to 1.53, p=0.54) including sudden deaths without a post-mortem, or 1.20 (0.86 to 1.68, p=0.29) in the confirmed group only.\n\nThe side-effect profiles are mirror images and matter to how a man chooses. Gynaecomastia of any grade affected 279 of 730 men (38 percent) on the agonist and 690 of 807 (86 percent) on patches (p<0.0001); hot flushes affected 628 (86 percent) on the agonist and 280 (35 percent) on patches (p<0.0001). The programme, reported in Clinical Oncology in 2024, also found bone mineral density at the lumbar spine fell by a mean 3.0 percent with the agonist and rose by 7.9 percent with patches, an estimated difference of 9.3 percent (5.3 to 13.4), with better metabolic parameters and quality of life.\n\nOncological outcomes for the non-metastatic and metastatic cohorts are reported separately and are the results that will decide whether patches become an option.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00303784","url":"https://clinicaltrials.gov/study/NCT00303784"},{"label":"ISRCTN registry ISRCTN70406718","url":"https://www.isrctn.com/ISRCTN70406718"},{"label":"PATCH long-term cardiovascular outcomes (Lancet 2021)","url":"https://doi.org/10.1016/S0140-6736(21)00100-8"},{"label":"PATCH and STAMPEDE repurposing programme (Clinical Oncology 2024)","url":"https://doi.org/10.1016/j.clon.2023.10.054"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":[],"companies":["mrc-ctu"],"institutions":["uclh"],"pathways":[],"terms":["adt","hormone-therapy","qol-pro"],"trials":["stampede","swog-9346"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00303784","phase":"2/3","setting":"Locally advanced or metastatic prostate cancer needing androgen suppression: oestradiol patches, four 100 microgram patches per 24 hours changed twice weekly and reduced to three if castrate at 4 weeks, against a luteinising hormone-releasing hormone agonist by local practice, with cardiovascular morbidity and mortality as the primary outcome of this analysis","sponsor":"MRC Clinical Trials Unit at UCL, funded by Cancer Research UK and the Medical Research Council","result":"Transdermal oestradiol suppressed testosterone as well as a luteinising hormone-releasing hormone agonist with no difference in time to first cardiovascular event (hazard ratio 1.11, 95 percent confidence interval 0.80 to 1.53); hot flushes 35 against 86 percent, gynaecomastia 86 against 38 percent, lumbar spine bone density plus 7.9 against minus 3.0 percent.","started":"2006-03","startedType":"actual","yearReported":2021,"enrolled":1694,"enrolledBasis":"randomised","enrolledNote":"1,694 men had been randomised at the cardiovascular analysis of July 2019; recruitment has since completed with 1,362 men in the non-metastatic cohort and 1,128 in the metastatic cohort, reported separately. The trial is registered as ISRCTN70406718 and recruits through the STAMPEDE platform as well.","outcomes":[{"endpoint":"Time to first cardiovascular event","primary":true,"arms":[{"name":"Transdermal oestradiol patches","n":904},{"name":"Luteinising hormone-releasing hormone agonist","n":790}],"hr":1.11,"ci":[0.8,1.53],"p":"0.54","source":"https://doi.org/10.1016/S0140-6736(21)00100-8"},{"endpoint":"Hot flushes, any grade","unit":"%","arms":[{"name":"Transdermal oestradiol patches","n":807,"value":35},{"name":"Luteinising hormone-releasing hormone agonist","n":730,"value":86}],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(21)00100-8"},{"endpoint":"Gynaecomastia, any grade","unit":"%","arms":[{"name":"Transdermal oestradiol patches","n":807,"value":86},{"name":"Luteinising hormone-releasing hormone agonist","n":730,"value":38}],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(21)00100-8"}],"replication":"The oestradiol comparison was also run inside the STAMPEDE platform, which is how the sample size was reached; no independent trial has repeated it."},{"id":"pathfinder-2","kind":"trial","name":"PATHFINDER 2","aka":[],"tldr":"PATHFINDER 2 is the US real-world study of the Galleri test that forms the core of its FDA submission.","summary":"PATHFINDER 2, trial NCT05155605 sponsored by GRAIL and reported in 2025, is the US real-world study of the Galleri multi-cancer blood test that forms the core of its FDA submission. It enrolled about 35,000 adults aged fifty or over who received Galleri alongside standard screening in a single-arm design, with 25,490 participants and one-year follow-up in the premarket approval application; a cancer signal was detected in about one percent, the positive predictive value was around sixty percent with very high specificity, and GRAIL reported at ESMO 2025 that adding the test found several times more cancers than standard screening alone. It improves on PATHFINDER 1, but the randomised NHS-Galleri trial did not meet its stage-shift endpoint, so whether detection translates into benefit is the open question.","status":"active","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05155605","url":"https://clinicaltrials.gov/study/NCT05155605"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["mced","cfdna-methylation-testing","methylation-profiling"],"targets":[],"drugs":["galleri"],"companies":["grail"],"institutions":[],"pathways":[],"terms":["ppv"],"trials":[],"people":["eric-klein","deb-schrag"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05155605","phase":"observational","setting":"~35,000 adults ≥50 receiving Galleri alongside standard screening, single-arm","sponsor":"GRAIL","started":"2021-12-08","startedType":"actual","yearReported":2025,"enrolled":35883,"enrolledBasis":"registry","outcomes":[{"endpoint":"Cancer signal detected","unit":"%","arms":[{"name":"Galleri, all participants","n":25578,"value":0.93}],"source":"https://clinicaltrials.gov/study/NCT05155605"},{"endpoint":"Positive predictive value","unit":"%","arms":[{"name":"Galleri","value":61.6}],"source":"https://clinicaltrials.gov/study/NCT05155605"},{"endpoint":"Specificity","unit":"%","arms":[{"name":"Galleri","value":99.6}],"source":"https://clinicaltrials.gov/study/NCT05155605"}],"replication":"Improves on PATHFINDER 1 (PPV 43%) with the refined classifier; the randomised NHS-Galleri trial did not meet its stage-shift primary endpoint."},{"id":"pathos","kind":"trial","name":"PATHOS","aka":[],"tldr":"PATHOS is the British trial asking whether people with HPV-positive throat cancer who have robotic surgery can safely be given less radiotherapy, or radiotherapy without chemotherapy, and keep better swallowing.","summary":"PATHOS enrols patients with HPV-positive oropharyngeal cancer whose tumours can be removed transorally. After surgery and neck dissection, intermediate-risk patients are randomised to 50 or 60 Gy of postoperative radiotherapy, and high-risk patients (extranodal extension or positive margins) to radiotherapy alone or radiotherapy with cisplatin. The phase 2 primary endpoint is patient-reported swallowing at one year; the phase 3 endpoint is overall survival.\n\nThe design mirrors ECOG-ACRIN E3311 but goes further by dropping chemotherapy in the high-risk group, which E3311 did not test. It also collects swallowing, feeding-tube use and quality-of-life data prospectively, since function is the reason for de-escalating.\n\nRecruitment across the United Kingdom, Ireland and other European centres continues; the phase 3 answer will decide whether reduced adjuvant treatment after transoral surgery becomes routine rather than a trial option.","status":"active","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02215265","url":"https://clinicaltrials.gov/study/NCT02215265"}],"tags":[],"related":[],"cancers":["oropharyngeal-cancer","hpv-positive-oropharyngeal-cancer"],"sections":[],"technologies":["tors","imrt-igrt"],"targets":[],"drugs":["cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":["hpv-p16","chemoradiation"],"trials":["ecog-e3311"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02215265","phase":"2/3","setting":"Resectable HPV-positive oropharyngeal cancer: transoral surgery and neck dissection, then risk-stratified reduction of adjuvant treatment (50 versus 60 Gy in intermediate risk; radiotherapy alone versus chemoradiation in high risk), with swallowing function and survival as endpoints","sponsor":"Velindre University NHS Trust","started":"2015-10","startedType":"actual","enrolledBasis":"registry","outcomes":[],"replication":"ECOG-ACRIN E3311 reported two-year progression-free survival near 95 percent with reduced-dose radiotherapy in the same intermediate-risk group."},{"id":"patidegib-gel-gorlin-phase-2","kind":"trial","name":"Patidegib gel in Gorlin syndrome (phase 2A)","aka":["patidegib topical gel phase 2A"],"tldr":"People born with Gorlin syndrome grow new basal cell carcinomas for life, and the pills that block the pathway cause side effects most cannot live with. Putting the drug on the skin instead was the obvious idea. A small trial hints that it works, but only in analyses decided after the results were seen.","summary":"Gorlin syndrome, caused by an inherited mutation in PTCH1, produces a continuous supply of new basal cell carcinomas, and is the human experiment that identified the hedgehog pathway as the driver of the sporadic disease too. Its sufferers are the people who would most benefit from long-term hedgehog inhibition and the people least able to tolerate it, since oral inhibitors have to be taken for years and their muscle spasms, taste loss and hair loss make that nearly impossible.\n\nPatidegib is a cyclopamine-derived inhibitor of smoothened formulated as a gel so that it reaches the skin without reaching the rest of the body. This small randomised double-blind phase 2A trial at two United Kingdom sites applied patidegib gel at 2 or 4 per cent, or vehicle, twice daily to the entire face for six months, and also to surgically eligible basal cell carcinomas at other sites.\n\nThe result must be stated with its qualification, which the paper itself supplies: post hoc analyses suggested that the gel reduced the number of new surgically eligible basal cell carcinomas and reduced the level of hedgehog signalling, with minimal adverse effects. Post hoc means the analyses were chosen after the data were seen, and seventeen participants cannot carry a pre-specified endpoint anyway. The authors conclude that the gel warrants further clinical development rather than that it works.\n\nThat is where the topical idea stands. A larger programme followed, including a phase 3 in Gorlin syndrome, and the record for it is on the basal cell carcinoma page. The reason to keep this small study is that it states the problem the whole class has: a drug that works and that people cannot take is not yet a treatment.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02762084","url":"https://clinicaltrials.gov/study/NCT02762084"},{"label":"Phase 2A report (British Journal of Dermatology 2025)","url":"https://doi.org/10.1093/bjd/ljae444"},{"label":"Phase 2A report on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/39545486/"}],"tags":[],"related":[],"cancers":["basal-cell-carcinoma","skin-cancer"],"sections":[],"technologies":["hedgehog-inhibitors"],"targets":["smoothened"],"drugs":["patidegib"],"companies":[],"institutions":[],"pathways":["hedgehog"],"terms":["hedgehog-inhibitor-tolerability","inherited-skin-cancer-syndromes"],"trials":["erivance","stevie"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02762084","phase":"2","setting":"Gorlin syndrome, in which an inherited PTCH1 mutation drives continuous formation of new basal cell carcinomas: patidegib topical gel at 2 or 4 per cent against vehicle, applied twice daily to the whole face for six months, with the number of new surgically eligible basal cell carcinomas and hedgehog pathway signalling as the endpoints","sponsor":"PellePharm, run at two United Kingdom sites","result":"Post hoc analyses in 17 participants suggested that patidegib topical gel reduced the number of new surgically eligible basal cell carcinomas and the level of hedgehog signalling, with minimal adverse effects; no pre-specified endpoint was met.","started":"2016-06-06","startedType":"actual","yearReported":2025,"enrolled":17,"enrolledBasis":"registry","outcomes":[{"endpoint":"New surgically eligible basal cell carcinomas over 6 months","primary":true,"unit":"post hoc analysis","arms":[{"name":"Patidegib topical gel 2 or 4 per cent","n":17,"note":"reduced against vehicle on post hoc analysis, with reduced hedgehog signalling and minimal adverse effects; the trial was not powered for a pre-specified endpoint"}],"source":"https://doi.org/10.1093/bjd/ljae444"}],"replication":"The phase 3 programme in Gorlin syndrome that followed is recorded on the basal cell carcinoma page as NCT06050122; no peer-reviewed phase 3 report of topical patidegib had been published when this record was written."},{"id":"nct07223424","kind":"trial","name":"Patient Preference for Subcutaneous vs. Intravenous Immune Therapy","aka":["PSI-Immune"],"tldr":"A phase 2 trial of nivolumab and pembrolizumab in colorectal cancer, run by Diwakar Davar, now recruiting.","summary":"Patient Preference for Subcutaneous vs. Intravenous Immune Therapy is a phase 2, randomised interventional study registered as NCT07223424 by Diwakar Davar, with a registry enrolment figure of 880 participants, started 2025-11-04 and due to reach its primary completion in 2030-11-30. Interventions recorded: nivolumab; pembrolizumab. Conditions listed: Renal Cell Carcinoma; Non Small Cell Lung Cancer; Melanoma; Colo-rectal Cancer (dMMR/MSI-H CRC); Hepatocellular Carcinoma; Ulcerative Colitis; Esophageal Cancer; Squamous Cell Carcinoma; Gastric/GEJ; Cervical Cancer; Gastro-Esophageal Adenocarcinoma; Esophageal Adenocarcinoma. Primary outcome: Preference for Subcutaneous Nivolumab Treatment; Preference for Subcutaneous Pembrolizumab Treatment. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07223424","url":"https://clinicaltrials.gov/study/NCT07223424"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07223424","phase":"2","setting":"Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)","sponsor":"Diwakar Davar","started":"2025-11-04","startedType":"actual","enrolled":880,"enrolledBasis":"registry","outcomes":[]},{"id":"patina","kind":"trial","name":"PATINA","aka":[],"tldr":"PATINA showed that adding the CDK4/6 inhibitor palbociclib to maintenance antibody and hormone treatment kept breast cancers that are both hormone receptor- and HER2-positive under control for markedly longer.","summary":"About half of HER2-positive breast cancers also express hormone receptors, and the two signalling routes cross-talk. PATINA randomised 518 patients with hormone receptor-positive, HER2-positive metastatic breast cancer who had completed four to eight cycles of induction chemotherapy with trastuzumab and pertuzumab without progression to maintenance anti-HER2 therapy plus endocrine therapy with or without palbociclib. The primary endpoint was investigator-assessed progression-free survival.\n\nPalbociclib lengthened progression-free survival substantially with manageable toxicity, mainly neutropenia. The result, reported in December 2024, established CDK4/6 inhibition as part of maintenance for this double-positive group.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02947685","url":"https://clinicaltrials.gov/study/NCT02947685"}],"tags":["subtype-trials"],"related":[],"cancers":["breast-her2-positive","breast-hr-positive","breast-cancer"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["palbociclib","trastuzumab","pertuzumab","letrozole"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-patina-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02947685","phase":"3","setting":"Hormone receptor-positive, HER2-positive metastatic breast cancer after induction chemotherapy with anti-HER2 therapy: maintenance anti-HER2 therapy and endocrine therapy with or without palbociclib","sponsor":"Alliance Foundation Trials with Pfizer","result":"Palbociclib added to maintenance anti-HER2 and endocrine therapy lengthened progression-free survival.","started":"2017-06-21","startedType":"actual","yearReported":2024,"enrolled":518,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (investigator-assessed)","primary":true,"unit":"months","arms":[{"name":"Palbociclib + anti-HER2 + endocrine maintenance","n":261,"value":44.3,"note":"Median follow-up 53.5 months"},{"name":"Anti-HER2 + endocrine maintenance","n":257,"value":29.1}],"hr":0.75,"ci":[0.59,0.96],"p":"0.02 (two-sided)","source":"https://doi.org/10.1056/nejmoa2511218"},{"endpoint":"Grade 3 adverse events","unit":"%","arms":[{"name":"Palbociclib + anti-HER2 + endocrine maintenance","n":261,"value":79.7,"note":"Predominantly neutropenia"},{"name":"Anti-HER2 + endocrine maintenance","n":257,"value":30.6}],"source":"https://doi.org/10.1056/nejmoa2511218"},{"endpoint":"Grade 4 adverse events","unit":"%","arms":[{"name":"Palbociclib + anti-HER2 + endocrine maintenance","n":261,"value":10},{"name":"Anti-HER2 + endocrine maintenance","n":257,"value":3.6}],"source":"https://doi.org/10.1056/nejmoa2511218"}]},{"id":"patricia","kind":"trial","name":"PATRICIA","aka":["HPV-008","HPV 008","PApilloma TRIal against Cancer In young Adults","580299/008"],"tldr":"PATRICIA showed that three doses of a vaccine against the two human papillomavirus types behind most cervical cancers prevented almost all of the type-specific high-grade cervical precancers in young women who were free of those types when vaccinated, which carried Cervarix to approval in Europe and the United States.","summary":"PATRICIA (PApilloma TRIal against Cancer In young Adults; Cervarix product information study HPV-008; NCT00122681) was a multinational, double-blind, randomised, controlled phase 3 trial of the HPV-16/18 AS04-adjuvanted vaccine in women aged 15 to 25 years. Women received the HPV vaccine or a hepatitis A vaccine control at months 0, 1 and 6.\n\nThe primary endpoint was vaccine efficacy against cervical intraepithelial neoplasia grade 2 or worse (CIN2+) associated with HPV-16 or HPV-18 in the according-to-protocol cohort for efficacy (women seronegative at baseline and DNA negative at baseline and month 6 for the corresponding type; vaccine 8,093, control 8,069). In the Lancet 2009 final event-driven analysis, after a mean follow-up of 34.9 months from the third dose, vaccine efficacy was 92.9 percent (96.1 percent CI 79.9 to 98.3) in the primary analysis and 98.1 percent (88.4 to 100) when probable causality to HPV type was assigned in lesions infected with several oncogenic types. Efficacy against CIN2+ irrespective of HPV type was 30.4 percent in the total vaccinated cohort and 70.2 percent in women with no evidence of oncogenic HPV infection at baseline, and cross-protection against CIN2+ associated with HPV-31, HPV-33 and HPV-45 was seen.\n\nThe Cervarix product information names the study HPV-008 and quotes the same 92.9 percent event-triggered figure. ClinicalTrials.gov registers the trial with condition papillomavirus infection rather than a cancer, which is why the automated pass never attached it to the vaccine record.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00122681","url":"https://clinicaltrials.gov/study/NCT00122681"},{"label":"Lancet 2009","url":"https://doi.org/10.1016/S0140-6736(09)61248-4"},{"label":"Cervarix EPAR (EMA)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cervarix"}],"tags":[],"related":[],"cancers":["cervical"],"sections":["prevention"],"technologies":["hpv-vaccine"],"targets":[],"drugs":["hpv-bivalent-vaccine"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-patricia-paavonen-lancet-2009"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00122681","phase":"3","setting":"Women aged 15 to 25 years: HPV-16/18 AS04-adjuvanted vaccine versus hepatitis A vaccine control at months 0, 1 and 6, for prevention of cervical precancer associated with HPV-16 or HPV-18","sponsor":"GlaxoSmithKline","result":"Vaccine efficacy against CIN2+ associated with HPV-16/18 92.9% (96.1% CI 79.9 to 98.3) in the according-to-protocol efficacy cohort; 98.1% with HPV-type causality assigned.","started":"2004-05-06","startedType":"actual","yearReported":2009,"enrolled":18644,"enrolledBasis":"randomised","enrolledNote":"The Lancet 2009 final analysis reports a total vaccinated cohort of 9,319 women on the HPV-16/18 vaccine and 9,325 on the hepatitis A control (18,644); ClinicalTrials.gov NCT00122681 lists an actual enrolment of 18,729.","outcomes":[{"endpoint":"Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (according-to-protocol cohort for efficacy, primary analysis)","primary":true,"unit":"%","arms":[{"name":"HPV-16/18 AS04-adjuvanted vaccine","n":8093,"value":92.9,"note":"96.1% confidence interval 79.9 to 98.3; efficacy is relative to the control arm"},{"name":"Hepatitis A vaccine control","n":8069,"note":"Reference arm; the abstract reports efficacy, not a control-arm rate"}],"ci":[79.9,98.3],"source":"https://doi.org/10.1016/S0140-6736(09)61248-4"},{"endpoint":"Vaccine efficacy against CIN2+ irrespective of HPV type (total vaccinated cohort, no evidence of oncogenic HPV at baseline)","unit":"%","arms":[{"name":"HPV-16/18 AS04-adjuvanted vaccine","n":5822,"value":70.2,"note":"96.1% confidence interval 54.7 to 80.9"},{"name":"Hepatitis A vaccine control","n":5819}],"ci":[54.7,80.9],"source":"https://doi.org/10.1016/S0140-6736(09)61248-4"}],"replication":"FUTURE I and II established the same class effect for the quadrivalent vaccine; the Costa Rica Vaccine Trial and KEN SHE later showed that one dose of an HPV vaccine protects as well as two or three."},{"id":"nct07761533","kind":"trial","name":"PBSS1113 in Combination With Azacitidine to Treat Patients With AML/MDS","aka":[],"tldr":"A phase 1/2 trial of PBSS1113 in acute myeloid leukaemia and myelodysplastic syndromes / neoplasms, run by Chaser Therapeutics, Inc., now recruiting.","summary":"PBSS1113 in Combination With Azacitidine to Treat Patients With AML/MDS is a phase 1/2 interventional study registered as NCT07761533 by Chaser Therapeutics, Inc., with 29 participants planned, started 2025-09-08 and due to reach its primary completion in 2027-09. Interventions recorded: PBSS1113.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07761533","url":"https://clinicaltrials.gov/study/NCT07761533"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","mds"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["azacitidine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07761533","phase":"1/2","setting":"A Phase Ib/II, Open-Label, Dose-Escalation and Cohort Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of PBSS1113 in Combination With Azacitidine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome","sponsor":"Chaser Therapeutics, Inc.","started":"2025-09-08","startedType":"actual","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06391905","kind":"trial","name":"PCSK9 Inhibitors in Combination With Advanced Treatment Strategies for the Treatment of Advanced Colorectal Cancer With pMMR/MSS","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Guangdong Provincial People's Hospital, not yet recruiting.","summary":"PCSK9 Inhibitors in Combination With Advanced Treatment Strategies for the Treatment of Advanced Colorectal Cancer With pMMR/MSS is a phase 2, randomised interventional study registered as NCT06391905 by Guangdong Provincial People's Hospital, with a registry enrolment figure of 60 participants, started 2024-05-06 and due to reach its primary completion in 2028-04-06. Interventions recorded: PCSK9 inhibitor in combination with standard advanced first-line regimen group; standard advanced first-line regimen group. Conditions listed: Colorectal Cancer. Primary outcome: Objective response rateObjective response rate (ORR). Colorectal eligibility wording from the registry: \"Histologically confirmed colorectal adenocarcinoma with pMMR/MSS;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06391905","url":"https://clinicaltrials.gov/study/NCT06391905"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06391905","phase":"2","setting":"PCSK9 Inhibitors in Combination With Advanced Treatment Strategies for the Treatment of Advanced Colorectal Cancer With pMMR/MSS","sponsor":"Guangdong Provincial People's Hospital","started":"2024-05-06","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07277842","kind":"trial","name":"PD-1 + FOLFOXIRI vs CAPOX as Total Neoadjuvant Therapy for pMMR Low Rectal Cancer","aka":[],"tldr":"A phase 3 trial of serplulimab in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"PD-1 + FOLFOXIRI vs CAPOX as Total Neoadjuvant Therapy for pMMR Low Rectal Cancer is a phase 3, randomised interventional study registered as NCT07277842 by Sun Yat-sen University, with a registry enrolment figure of 382 participants, started 2025-12-29 and due to reach its primary completion in 2028-12-29. Interventions recorded: Serplulimab; FOLFOXIRI chemotherapy; CAPOX chemotherapy; Long-course pelvic radiotherapy. Conditions listed: Locally Advanced Low Rectal Adenocarcinoma; pMMR (Microsatellite Stable Rectal Cancer). Primary outcome: 3-year Event-Free Survival (EFS). Colorectal eligibility wording from the registry: \"* Histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07277842","url":"https://clinicaltrials.gov/study/NCT07277842"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07277842","phase":"3","setting":"A Multicenter, Prospective, Phase III Randomized Controlled Trial of PD-1 Antibody Plus FOLFOXIRI Combined With Radiotherapy Versus CAPOX Combined With Radiotherapy as Total Neoadjuvant Therapy for pMMR Locally Advanced Low Rectal Cancer","sponsor":"Sun Yat-sen University","started":"2025-12-29","startedType":"estimated","enrolled":382,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06359275","kind":"trial","name":"PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients","aka":[],"tldr":"A phase 2 trial of nab-paclitaxel and gemcitabine in pancreatic cancer, run by Fudan University, now recruiting.","summary":"PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients is a phase 2, interventional study registered as NCT06359275 by Fudan University, with a registry enrolment figure of 81 participants, started 2024-06-01 and due to reach its primary completion in 2025-12. Interventions recorded: PD-1; Nab-paclitaxel; Gemcitabine; PULSAR. Conditions listed: Pancreatic Cancer. Primary outcome: Progression-free survival (PFS). Pancreatic eligibility wording from the registry: \"Locally advanced pancreatic adenocarcinoma confirmed by histopathology or cytology, or pancreatic cancer with only local recurrence but no distant metastasis after surgery (local recurrence includes tumor bed recurrence and regional lymph node metastasis, which needs to be confirmed by biopsy pathol\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06359275","url":"https://clinicaltrials.gov/study/NCT06359275"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["nab-paclitaxel","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06359275","phase":"2","setting":"A Phase II Study on the Safety and Efficacy of PD-1 Combined With Nab-paclitaxel/Gemcitabine and PULSAR in the Treatment of Locally Advanced Unresectable Pancreatic Cancer and Local Recurrence After Surgery.","sponsor":"Fudan University","started":"2024-06-01","startedType":"actual","enrolled":81,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03774732","kind":"trial","name":"PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer","aka":["NIRVANA-LUNG"],"tldr":"A phase 3 trial of pembrolizumab in lung cancer, run by UNICANCER, active but no longer recruiting.","summary":"PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT03774732 by UNICANCER, with a registry enrolment figure of 327 participants, started 2018-01-24 and due to reach its primary completion in 2026-12-22. Interventions recorded: Radiotherapy; Pembrolizumab; Chemotherapy. Conditions listed: Non Small Cell Lung Cancer; Non Small Cell Lung Cancer Metastatic; Non-Small Cell Carcinoma of Lung, TNM Stage 4. Primary outcome: 1-year Overall Survival. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed advanced (stage IIIB/IIIC/IV), squamous or non-squamous NSCLC\". Sites: France, Monaco. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03774732","url":"https://clinicaltrials.gov/study/NCT03774732"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["pembrolizumab"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03774732","phase":"3","setting":"PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer","sponsor":"UNICANCER","started":"2018-01-24","startedType":"actual","enrolled":327,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04634058","kind":"trial","name":"PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment","aka":[],"tldr":"A phase 2 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by Shanghai Zhongshan Hospital, active and no longer recruiting.","summary":"PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment is a phase 2 interventional study registered as NCT04634058 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 40 participants, started 2021-03-26 and due to reach its primary completion in 2023-09-30. Interventions recorded: PD-L1 antibody combined with CTLA-4 antibody. Conditions listed: Cholangiocarcinoma, Intrahepatic, PD-L1, CTLA4. Gallbladder cancer is named in the registry entry: \"2. Hilar cholangiocarcinoma or extrahepatic cholangiocarcinoma or periampullary carcinoma or gallbladder cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04634058","url":"https://clinicaltrials.gov/study/NCT04634058"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","ampullary"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04634058","phase":"2","setting":"PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment: a Single-arm, Phase II Clinical Study","sponsor":"Shanghai Zhongshan Hospital","started":"2021-03-26","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07477418","kind":"trial","name":"PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP)","aka":["PRISM-TAMP"],"tldr":"A phase 1/2 trial in pancreatic cancer, run by University of Vermont, not yet recruiting.","summary":"PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP) is a phase 1/2, interventional study registered as NCT07477418 by University of Vermont, with a registry enrolment figure of 10 participants, started 2026-12 and due to reach its primary completion in 2030-12. Interventions recorded: Gemcitabine Delivered by Transarterial Microperfusion. Conditions listed: Pancreatic Ductal Adenocarcinoma (PDAC); Borderline Resectable Pancreatic Cancer; Pancreatic Neoplasms. Primary outcome: Safety and Tolerability of Neoadjuvant Transarterial Gemcitabine Delivery. Pancreatic eligibility wording from the registry: \"* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07477418","url":"https://clinicaltrials.gov/study/NCT07477418"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07477418","phase":"1/2","setting":"PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP): A Phase Ib/II Open-Label Trial","sponsor":"University of Vermont","started":"2026-12","startedType":"estimated","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05286814","kind":"trial","name":"PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarc","aka":[],"tldr":"A phase 2 trial of dexamethasone and floxuridine in colorectal cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma is a phase 2, interventional study registered as NCT05286814 by National Cancer Institute (NCI), with a registry enrolment figure of 70 participants, started 2022-10-24 and due to reach its primary completion in 2027-12-31. Interventions recorded: Dexamethasone; PDS01ADC; Intera 3000 Hepatic Artery Infusion Pump (HAIP); Floxuridine. Conditions listed: Metastatic Colorectal Cancer (Mcrc); Intrahepatic Cholangiocarcinoma (Icc); Intrahepatic Bile Duct Cancer; Colorectal Neoplasms; Colorectal Cancer; Cholangiocarcinoma; Bile Duct Neoplasms; Bile Duct Cancer; Adrenocortical Carcinoma (ACC); Adrenal Cortical Carcinoma; Adrenal Gland Cancer; Adrenal Gland Neoplasms; Adrenal Cortex Neoplasms. Primary outcome: Determine overall response rates. Colorectal eligibility wording from the registry: \"* Metastatic colorectal cancer (mCRC)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05286814","url":"https://clinicaltrials.gov/study/NCT05286814"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["dexamethasone","floxuridine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05286814","phase":"2","setting":"Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","sponsor":"National Cancer Institute (NCI)","started":"2022-10-24","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05801237","kind":"trial","name":"PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor","aka":[],"tldr":"A phase 1/2 trial of PE0116&PE0105 in advanced solid tumours, run by Shanghai HyaMab Biotech Co.,Ltd., now recruiting.","summary":"PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor is a phase 1/2 interventional study registered as NCT05801237 by Shanghai HyaMab Biotech Co.,Ltd., with 120 participants planned, started 2023-09-21 and due to reach its primary completion in 2026-09. Interventions recorded: PE0116&PE0105.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05801237","url":"https://clinicaltrials.gov/study/NCT05801237"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05801237","phase":"1/2","setting":"A Phase Ib/II Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor","sponsor":"Shanghai HyaMab Biotech Co.,Ltd.","started":"2023-09-21","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"peace-1","kind":"trial","name":"PEACE-1","aka":[],"tldr":"PEACE-1 is the European triplet trial: abiraterone added to hormone therapy and docetaxel improves survival, especially in high-volume disease.","summary":"PEACE-1, trial NCT01957436 sponsored by UNICANCER and Gustave Roussy and reported in 2021, is the European triplet trial in de novo metastatic hormone-sensitive prostate cancer, using a two-by-two factorial design to test adding abiraterone and adding prostate radiotherapy to androgen deprivation plus docetaxel. It randomised 1,173 men and showed that abiraterone improved overall survival, with the largest benefit in high-volume disease, while prostate radiotherapy reduced serious urinary events. OnCo links it to prostate cancer, abiraterone acetate, docetaxel, Karim Fizazi and Gustave Roussy, and its result is consistent with ARASENS for triplet therapy in high-volume de novo disease. Whether local radiotherapy to the prostate should be routine in men with metastatic disease is the second question the factorial design raised. Abiraterone acetate has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT01957436","url":"https://clinicaltrials.gov/study/NCT01957436"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["abiraterone","docetaxel"],"companies":["unicancer"],"institutions":["gustave-roussy"],"pathways":[],"terms":[],"trials":[],"people":["karim-fizazi"],"bottlenecks":[],"keyPapers":["paper-peace-1-lancet-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01957436","phase":"3","setting":"De novo metastatic hormone-sensitive prostate cancer: ADT + docetaxel ± abiraterone ± prostate radiotherapy (2×2 factorial)","sponsor":"UNICANCER / Gustave Roussy","result":"OS HR 0.82 in the overall population and HR 0.75 in the ADT plus docetaxel population; HR 0.72 in high-volume disease.","started":"2013-11-13","startedType":"actual","yearReported":2021,"enrolled":1173,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, abiraterone vs no abiraterone (with ADT + docetaxel)","primary":true,"unit":"months","arms":[{"name":"Abiraterone + ADT + docetaxel","value":66},{"name":"ADT + docetaxel","value":52}],"hr":0.75,"ci":[0.59,0.95],"p":"0.017","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00367-1/fulltext"}],"replication":"Consistent with ARASENS for triplet therapy in high-volume de novo disease."},{"id":"peace-3","kind":"trial","name":"PEACE-3 (EORTC 1333)","aka":["PEACE-3","PEACE III","EORTC 1333-GUCG"],"tldr":"Combining the bone-seeking radioactive drug radium-223 with enzalutamide made men live about six months longer, and the fractures that sank the earlier version of this idea were prevented by giving bone-protecting drugs to everyone.","summary":"ERA 223 combined radium-223 with abiraterone and produced more fractures and more deaths, and the trial was unblinded early. PEACE-3 is the trial that tested the same idea properly, with enzalutamide instead of abiraterone and, from March 2018, with bone-protecting agents made mandatory for every participant.\n\nFrom November 2015 to March 2023, 446 men were randomly assigned to enzalutamide alone (224) or enzalutamide with six cycles of radium-223 (222). The final overall survival analysis was triggered on 1 May 2025.\n\nWith a median follow-up of 58 months and 317 deaths, the hazard ratio for overall survival was 0.76 (95 percent confidence interval 0.60 to 0.96, p=0.0096), crossing the predefined significance level of 0.0248. Median overall survival was 32.6 months (29.3 to 38.2) with enzalutamide alone and 38.2 months (33.1 to 44.8) with the combination. The hazard ratio for radiological progression-free survival, the primary endpoint, was 0.71 (0.57 to 0.89).\n\nThe combination costs toxicity. Grade 3 or worse treatment-emergent adverse events rose from 57.6 to 69.3 percent and treatment-related grade 3 or worse events from 18.8 to 28.9 percent, most frequently hypertension. The trial's own conclusion is that co-administration of a bone-protecting agent is required.\n\nPEACE-3 is the rare case of a field going back to a combination that harmed people, working out why, fixing it and proving it works.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02194842","url":"https://clinicaltrials.gov/study/NCT02194842"},{"label":"PEACE-3 final overall survival (Annals of Oncology 2026)","url":"https://doi.org/10.1016/j.annonc.2026.02.009"},{"label":"NICE TA412: radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases","url":"https://www.nice.org.uk/guidance/ta412"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["targeted-alpha-therapy","androgen-deprivation"],"targets":["androgen-receptor"],"drugs":["radium-223","enzalutamide","denosumab","zoledronic-acid"],"companies":["curie-nki-eortc","bayer"],"institutions":[],"pathways":[],"terms":["bone-metastases","castration-resistance","arpi"],"trials":["era-223","alsympca","vision"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02194842","phase":"3","setting":"Asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer with bone metastases: enzalutamide 160 mg daily alone against enzalutamide with six monthly injections of radium-223 at 55 kBq/kg, with bone-protecting agents made mandatory for all patients from March 2018, with radiological progression-free survival as the primary endpoint","sponsor":"European Organisation for Research and Treatment of Cancer, Genito-Urinary Cancers Group","result":"Median overall survival 38.2 months with enzalutamide plus radium-223 against 32.6 months with enzalutamide alone (hazard ratio 0.76, 95 percent confidence interval 0.60 to 0.96, p=0.0096); radiological progression-free survival hazard ratio 0.71 (0.57 to 0.89). Bone-protecting agents mandatory.","started":"2015-10","startedType":"actual","yearReported":2026,"enrolled":446,"enrolledBasis":"randomised","enrolledNote":"446 men were randomly assigned between November 2015 and March 2023.","outcomes":[{"endpoint":"Overall survival (median)","unit":"months","arms":[{"name":"Enzalutamide with radium-223","n":222,"value":38.2},{"name":"Enzalutamide alone","n":224,"value":32.6}],"hr":0.76,"ci":[0.6,0.96],"p":"0.0096","source":"https://doi.org/10.1016/j.annonc.2026.02.009"},{"endpoint":"Radiological progression-free survival","primary":true,"arms":[{"name":"Enzalutamide with radium-223","n":222},{"name":"Enzalutamide alone","n":224}],"hr":0.71,"ci":[0.57,0.89],"source":"https://doi.org/10.1016/j.annonc.2026.02.009"},{"endpoint":"Grade 3 or worse treatment-emergent adverse events","unit":"%","arms":[{"name":"Enzalutamide with radium-223","n":222,"value":69.3},{"name":"Enzalutamide alone","n":224,"value":57.6}],"source":"https://doi.org/10.1016/j.annonc.2026.02.009"}],"replication":"ERA 223 tested the same concept with abiraterone and without mandatory bone protection, and found no benefit and a fracture rate of 29 against 11 percent; the difference between the two trials is the bone-protecting agent and the partner drug."},{"id":"nct07214298","kind":"trial","name":"Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma","aka":[],"tldr":"A phase 1/2 trial of fluorouracil (5-FU), fOLFIRI (5-FU, leucovorin, irinotecan), leucovorin (folinic acid) and cAPOX (capecitabine, oxaliplatin) in pancreatic cancer, run by Roswell Park Cancer Institute, now recruiting.","summary":"Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma is a phase 1/2, interventional study registered as NCT07214298 by Roswell Park Cancer Institute, with a registry enrolment figure of 35 participants, started 2026-02-16 and due to reach its primary completion in 2028-02-16. Interventions recorded: Biopsy Procedure; Biospecimen Collection; Computed Tomography; Fluorouracil; Irinotecan; Leucovorin Calcium; Magnetic Resonance Imaging; Oxaliplatin; Pegcetacoplan. Conditions listed: Metastatic Pancreatic Ductal Adenocarcinoma; Stage IV Pancreatic Cancer AJCC v8. Primary outcome: Incidence of treatment-related adverse events (AE) (Phase I); Progression-free survival (Phase II). Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07214298","url":"https://clinicaltrials.gov/study/NCT07214298"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","folfiri","leucovorin","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07214298","phase":"1/2","setting":"A Phase I/II Study of Complement Inhibition in Pancreatic Ductal Adenocarcinoma","sponsor":"Roswell Park Cancer Institute","started":"2026-02-16","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03260894","kind":"trial","name":"Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)","aka":["KEYNOTE-679"],"tldr":"A phase 3 trial of Pembrolizumab, Epacadostat, Sunitinib and Pazopanib in Renal cell carcinoma, run by Incyte Corporation, completed.","summary":"Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302) is a phase 3 interventional study registered as NCT03260894 by Incyte Corporation, with 129 participants recorded, started 2017-12-07 and reaching its primary completion in 2018-08-22. Interventions recorded: Pembrolizumab, Epacadostat, Sunitinib, Pazopanib. Conditions recorded: Renal Cell Carcinoma (RCC).\n\nLinked to the drug Epacadostat because the registry names it among its interventions and Renal cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03260894","url":"https://clinicaltrials.gov/study/NCT03260894"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","epacadostat","sunitinib","pazopanib"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03260894","phase":"3","setting":"A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302)","sponsor":"Incyte Corporation","started":"2017-12-07","startedType":"actual","yearReported":2019,"enrolled":129,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC), Objective Response (CR+PR)","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab + Epacadostat","n":64,"value":31.3,"note":"95% CI 20.2 to 44.1; Figures from the ClinicalTrials.gov results section (first posted 2019-09-10), not from a publication"},{"name":"SoC (Sunitinib or Pazopanib)","n":65,"value":29.2,"note":"95% CI 18.6 to 41.8"}],"source":"https://clinicaltrials.gov/study/NCT03260894?tab=results"}]},{"id":"nct06788912","kind":"trial","name":"Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)","aka":["KEYMAKER-U01"],"tldr":"A phase 2 trial of Pembrolizumab, Cisplatin, Gemcitabine, Pemetrexed, Sacituzumab tirumotecan and Dexamethasone in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01) is a phase 2 interventional study registered as NCT06788912 by Merck Sharp & Dohme LLC, with 60 participants planned, started 2025-03-20 and due to reach its primary completion in 2032-02-06. Interventions recorded: Pembrolizumab (neoadjuvant), Cisplatin, Gemcitabine, Pemetrexed, Sacituzumab tirumotecan and H1 receptor antagonist.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06788912","url":"https://clinicaltrials.gov/study/NCT06788912"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","cisplatin","gemcitabine","pemetrexed","sacituzumab-tirumotecan","dexamethasone"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06788912","phase":"2","setting":"KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-03-20","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06976944","kind":"trial","name":"Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer","aka":["PRELUDE"],"tldr":"A phase 2 trial of pembrolizumab, paclitaxel / nab-paclitaxel and bevacizumab in triple-negative breast cancer, run by Yukinori Ozaki, now recruiting.","summary":"Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer is a phase 2, randomised interventional study registered as NCT06976944 by Yukinori Ozaki, with a registry enrolment figure of 24 participants, started 2025-06-24 and due to reach its primary completion in 2029-09. Interventions recorded: Pembrolizumab; Paclitaxel; Bevacizumab. Conditions listed: Recurrent Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Participants must have recurred after treatment with an anti-PD-1/PD-L1 antibody administered as monotherapy or in combination with other ICIs or chemotherapies as a perioperative drug therapy for triple negative breast cancer\". Sites: Japan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06976944","url":"https://clinicaltrials.gov/study/NCT06976944"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["pembrolizumab","paclitaxel","bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06976944","phase":"2","setting":"Randomized Phase II Study of Pembrolizumab + Paclitaxel +/- Bevacizumab in Patients With Recurrent Triple-Negative Breast Cancer Who Received Perioperative Immunotherapy","sponsor":"Yukinori Ozaki","started":"2025-06-24","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04153734","kind":"trial","name":"Pembrolizumab + Platinum Doublets Without Radiation for Programmed Death-ligand 1 (PD-L1) ≥50% Locally Advanced NSCLC","aka":["Evolution"],"tldr":"A phase 2 trial of pembrolizumab, carboplatin, pemetrexed and nab-paclitaxel in lung cancer, run by Kobe Minimally Invasive Cancer Center, not yet recruiting.","summary":"Pembrolizumab + Platinum Doublets Without Radiation for Programmed Death-ligand 1 (PD-L1) ≥50% Locally Advanced NSCLC is a phase 2, interventional study registered as NCT04153734 by Kobe Minimally Invasive Cancer Center, with a registry enrolment figure of 21 participants, started 2019-12-01 and due to reach its primary completion in 2021-11-30. Interventions recorded: Pembrolizumab; Cis Platinum; Carboplatin; Pemetrexed; nab paclitaxel. Conditions listed: Locally Advanced Non-small Cell Lung Cancer. Primary outcome: 2-year PFS rate. Lung eligibility wording from the registry: \"Histologically confirmed NSCLC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04153734","url":"https://clinicaltrials.gov/study/NCT04153734"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pembrolizumab","carboplatin","pemetrexed","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04153734","phase":"2","setting":"Pembrolizumab + Platinum Doublets Without Radiation for Patients With PD-L1 ≥50% Locally Advanced Non-small Cell Lung Cancer: a Multicenter Prospective Single Arm Phase II Study","sponsor":"Kobe Minimally Invasive Cancer Center","started":"2019-12-01","startedType":"estimated","enrolled":21,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07486687","kind":"trial","name":"Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy","aka":["PLANET"],"tldr":"A phase 3 trial of pembrolizumab and olaparib in triple-negative breast cancer, run by The Netherlands Cancer Institute, not yet recruiting.","summary":"Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy is a phase 3, randomised interventional study registered as NCT07486687 by The Netherlands Cancer Institute, with a registry enrolment figure of 1000 participants, started 2026-04 and due to reach its primary completion in 2032-04. Interventions recorded: Standard of care plus pembrolizumab; Standard of care (capecitabine or olaparib). Conditions listed: Triple Negative Breast Cancer (TNBC), Early Setting; Early Stage Triple-Negative Breast Carcinoma; Triple -Negative Breast Cancer; Breast Cancer Stage II; Breast Cancer Stage III. Triple-negative eligibility wording from the registry: \"Stage II or III TNBC prior to the start of neoadjuvant treatment\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07486687","url":"https://clinicaltrials.gov/study/NCT07486687"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["pembrolizumab","olaparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07486687","phase":"3","setting":"PembroLizumab Adjuvant in Patients With Early-stage Triple NEgaTive Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy - the Multicenter, Randomized Phase III, Pragmatic PLANET Trial","sponsor":"The Netherlands Cancer Institute","started":"2026-04","startedType":"estimated","enrolled":1000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05491083","kind":"trial","name":"Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer","aka":["ComPACT"],"tldr":"A phase 1/2 trial in triple-negative breast cancer, run by National University Hospital, Singapore, now recruiting.","summary":"Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer is a phase 1/2, interventional study registered as NCT05491083 by National University Hospital, Singapore, with a registry enrolment figure of 51 participants, started 2023-06-12 and due to reach its primary completion in 2026-12-31. Interventions recorded: Pembrolizumab & ADG106 (Phase Ib); Pembrolizumab & ADG106 (Phase II). Conditions listed: Advanced Solid Tumor; Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Patients with histologically or cytologically confirmed TNBC, defined by expression of estrogen (ER) and progesterone receptors (PR) of \\<1% and HER2 IHC score of 0 or 1+ or HER2 IHC score of 2+ but HER2 FISH negative\". Sites: Singapore. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05491083","url":"https://clinicaltrials.gov/study/NCT05491083"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05491083","phase":"1/2","setting":"A Phase 1b Followed by Phase II Expansion Trial of Combination of Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer (ComPACT)","sponsor":"National University Hospital, Singapore","started":"2023-06-12","startedType":"actual","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06078384","kind":"trial","name":"Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC","aka":["ETNA"],"tldr":"A phase 2 trial of paclitaxel / nab-paclitaxel in triple-negative breast cancer, run by UNICANCER, now recruiting.","summary":"Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC is a phase 2, interventional study registered as NCT06078384 by UNICANCER, with a registry enrolment figure of 354 participants, started 2024-12-27 and due to reach its primary completion in 2032-01-01. Interventions recorded: Pembrolizumab 25 mg/ml; Paclitaxel injection. Conditions listed: Triple-negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Histologically confirmed and radically removed pT1b/c N0M0 TNBC as defined according to AJCC TNM stage-8th version,\". Sites: France, Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06078384","url":"https://clinicaltrials.gov/study/NCT06078384"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["paclitaxel"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06078384","phase":"2","setting":"Adjuvant Pembrolizumab and Chemotherapy or Surveillance in Early Triple Negative breAst Cancer With High Stromal Tumor-infiltrating Lymphocytes (TILs) Score","sponsor":"UNICANCER","started":"2024-12-27","startedType":"actual","enrolled":354,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05623319","kind":"trial","name":"Pembrolizumab and Olaparib Treatment of Extensive Small Cell Lung Cancer (ES-SCLC)","aka":["THOR"],"tldr":"A phase 2 trial of pembrolizumab and olaparib in lung cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS, now recruiting.","summary":"Pembrolizumab and Olaparib Treatment of Extensive Small Cell Lung Cancer (ES-SCLC) is a phase 2, interventional study registered as NCT05623319 by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS, with a registry enrolment figure of 60 participants, started 2023-03-27 and due to reach its primary completion in 2027-07. Interventions recorded: Pembrolizumab/Olaparib. Conditions listed: SCLC,Extensive Stage. Primary outcome: Progression free survival (PFS). Lung eligibility wording from the registry: \"Cytologically/histologically confirmed diagnosis of SCLC per the Veterans Administration Lung Study Group (VALG) staging system will be enrolled in this study\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05623319","url":"https://clinicaltrials.gov/study/NCT05623319"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["pembrolizumab","olaparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05623319","phase":"2","setting":"Phase 2 Trial of Translational Approach to First Line cHemoimmunotherapy Followed by Maintenance With pembrOlizumab and Olaparib in Extensive-Stage Small-Cell Lung CanceR.","sponsor":"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","started":"2023-03-27","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05903833","kind":"trial","name":"Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surge","aka":["PIERCE"],"tldr":"A phase 2 trial of Pembrolizumab, Lenvatinib in vulvar cancer, run by AGO Research GmbH, now recruiting.","summary":"Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy is a phase 2 interventional study registered as NCT05903833 by AGO Research GmbH, with 42 participants planned, started 2025-06-24 and due to reach its primary completion in 2027-10-30. Interventions recorded: Pembrolizumab, Lenvatinib. Conditions listed: Recurrent Vulvar Cancer, Persistent Vulvar Cancer, Metastatic Vulva Cancer, Locally Advanced Vulvar Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05903833","url":"https://clinicaltrials.gov/study/NCT05903833"}],"tags":["ctgov-ingest"],"related":[],"cancers":["vulvar","hpv-associated-vulvar-cancer","hpv-independent-vulvar-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["pembrolizumab","lenvatinib"],"companies":["ago-study-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05903833","phase":"2","setting":"Pembrolizumab in Combination With Lenvatinib in Pts With Recurrent, Persistent, Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy","sponsor":"AGO Research GmbH","started":"2025-06-24","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03358472","kind":"trial","name":"Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)","aka":["KEYNOTE-669"],"tldr":"A phase 3 trial of Pembrolizumab, Epacadostat, Cetuximab, Cisplatin and Carboplatin in Head and neck squamous cell carcinoma, run by Incyte Corporation, completed.","summary":"Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304) is a phase 3 interventional study registered as NCT03358472 by Incyte Corporation, with 89 participants recorded, started 2017-12-01 and reaching its primary completion in 2018-07-19. Interventions recorded: Pembrolizumab, Epacadostat, Cetuximab, Cisplatin, Carboplatin, 5-Fluorouracil. Conditions recorded: Head and Neck Cancer.\n\nLinked to the drug Epacadostat because the registry names it among its interventions and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03358472","url":"https://clinicaltrials.gov/study/NCT03358472"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","epacadostat","cetuximab","cisplatin","carboplatin"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03358472","phase":"3","setting":"A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First Line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)","sponsor":"Incyte Corporation","started":"2017-12-01","startedType":"actual","yearReported":2019,"enrolled":89,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab + Epacadostat","n":35,"value":31.4,"note":"95% CI 16.9 to 49.3; Figures from the ClinicalTrials.gov results section (first posted 2019-09-10), not from a publication"},{"name":"Pembrolizumab","n":19,"value":21.1,"note":"95% CI 6.1 to 45.6"},{"name":"EXTREME","n":35,"value":34.3,"note":"95% CI 19.1 to 52.2"}],"source":"https://clinicaltrials.gov/study/NCT03358472?tab=results"}]},{"id":"nct04976634","kind":"trial","name":"Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)","aka":[],"tldr":"A phase 2 trial of Pembrolizumab, Belzutifan and Lenvatinib in advanced solid tumours, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016) is a phase 2 interventional study registered as NCT04976634 by Merck Sharp & Dohme LLC, with 730 participants enrolled, started 2021-08-18 and due to reach its primary completion in 2027-03-22. Interventions recorded: Pembrolizumab, Belzutifan and Lenvatinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04976634","url":"https://clinicaltrials.gov/study/NCT04976634"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["pembrolizumab","belzutifan","lenvatinib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04976634","phase":"2","setting":"An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Multiple Solid Tumors","sponsor":"Merck Sharp & Dohme LLC","started":"2021-08-18","startedType":"actual","enrolled":730,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04547504","kind":"trial","name":"PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 %","aka":["PERSEE"],"tldr":"A phase 3 trial of pembrolizumab in lung cancer, run by University Hospital, Brest, active but no longer recruiting.","summary":"PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 % is a phase 3, randomised interventional study registered as NCT04547504 by University Hospital, Brest, with a registry enrolment figure of 349 participants, started 2020-12-22 and due to reach its primary completion in 2025-12-22. Interventions recorded: Pembrolizumab; Pembrolizumab and Chemotherapy drugs. Conditions listed: Non-small-cell Lung Cancer. Primary outcome: Progression-free survival (PFS) according to RECIST 1.1 assessed by blinded inependant centra review (BICR). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed NSCLC\". Sites: France. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04547504","url":"https://clinicaltrials.gov/study/NCT04547504"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04547504","phase":"3","setting":"Randomized, Open-label, Controlled Phase III Trial Comparing Pembrolizumab-platinum Based Chemotherapy Combination With Pembrolizumab Monotherapy in First Line Treatment of Non-small-cell Lung Cancers (NSCLC) With PDL1 Expression ≥50%","sponsor":"University Hospital, Brest","started":"2020-12-22","startedType":"actual","enrolled":349,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04014530","kind":"trial","name":"Pembrolizumab With Ataluren in Patients With Metastatic pMMR and dMMR Colorectal Carcinoma or Metastatic dMMR Endometrial Carcinoma: the ATAPEMBRO Study","aka":["ATAPEMBRO"],"tldr":"A phase 1/2 trial of pembrolizumab in colorectal cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), now recruiting.","summary":"Pembrolizumab With Ataluren in Patients With Metastatic pMMR and dMMR Colorectal Carcinoma or Metastatic dMMR Endometrial Carcinoma: the ATAPEMBRO Study is a phase 1/2, interventional study registered as NCT04014530 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), with a registry enrolment figure of 47 participants, started 2019-08-01 and due to reach its primary completion in 2023-06-01. Interventions recorded: Ataluren + Pembrolizumab. Conditions listed: Colorectal Cancer; Endometrium Cancer. Primary outcome: Incidence of treatment-Emergent Adverse Event and the determination of the maximum tolerable dose of Ataluren.; Objective response rate. Colorectal eligibility wording from the registry: \"inaccessible by colonoscopy or CT-guided approaches or due to safety concerns) may submit an archived specimen only upon agreement from the Sponsor\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04014530","url":"https://clinicaltrials.gov/study/NCT04014530"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04014530","phase":"1/2","setting":"Study of Pembrolizumab Combined With Ataluren In Patients With Metastatic pMMR and dMMR Colorectal Adenocarcinomas or Metastatic dMMR Endometrial Carcinoma: the ATAPEMBRO Study","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","started":"2019-08-01","startedType":"actual","enrolled":47,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05093231","kind":"trial","name":"Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of pembrolizumab and olaparib in pancreatic cancer, run by Cambridge University Hospitals NHS Foundation Trust, now recruiting.","summary":"Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT05093231 by Cambridge University Hospitals NHS Foundation Trust, with a registry enrolment figure of 20 participants, started 2025-02-26 and due to reach its primary completion in 2027-07-31. Interventions recorded: Pembrolizumab; Olaparib. Conditions listed: Pancreatic Cancer. Primary outcome: Objective Response Rate (ORR). Sites: Australia, United Kingdom. United Kingdom sites listed: 15. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05093231","url":"https://clinicaltrials.gov/study/NCT05093231"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac","msi-high-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["pembrolizumab","olaparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Addenbrooke's Hospital (Cambridge); Glan Clwyd Hospital (Bodelwyddan); Velindre Cancer Centre (Cardiff); University Hospitals Coventry and Warwickshire (Coventry); Beatson West of Scotland Cancer Centre (Glasgow); St James' University Hospital (Leeds); Clatterbridge Cancer Centre (Liverpool); Guy's and St Thomas' NHS Foundation Trust (London); Royal Free Hospital (London); University College London Hospitals NHS Foundation Trust (London); The Christie (Manchester); Milton Keynes University Hospital (Milton Keynes) and 3 more."],"nct":"NCT05093231","phase":"2","setting":"A Phase II Study Combining Pembrolizumab With Olaparib in Metastatic Pancreatic Adenocarcinoma (PDA) Patients With Mismatch Repair Deficiency or Tumour Mutation Burden > 4 Mutations/Mb","sponsor":"Cambridge University Hospitals NHS Foundation Trust","started":"2025-02-26","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nci-anetumab-pembrolizumab-mpm","kind":"trial","name":"Pembrolizumab with or without anetumab ravtansine in mesothelin-positive pleural mesothelioma (NCI)","aka":[],"tldr":"The one trial still testing an antibody-drug conjugate in mesothelioma, combining it with PD-1 blockade on the theory that payload-induced cell death primes an immune response.","summary":"This National Cancer Institute study enrolled 49 patients with mesothelin-positive pleural mesothelioma after prior therapy. A phase 1 run-in established the dose of anetumab ravtansine with pembrolizumab, and the phase 2 part randomised patients to pembrolizumab with or without the conjugate. The study is active but no longer recruiting, with results awaited. It is the only remaining clinical test of an ADC in mesothelioma recorded on ClinicalTrials.gov.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03126630","url":"https://clinicaltrials.gov/study/NCT03126630"}],"tags":["owner-request"],"related":[],"cancers":["mesothelioma"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":["mesothelin"],"drugs":["anetumab-ravtansine","pembrolizumab"],"companies":[],"institutions":["nci"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03126630","phase":"1/2","setting":"Previously treated mesothelin-positive pleural mesothelioma; phase 1 safety run-in then randomisation between pembrolizumab alone and pembrolizumab with anetumab ravtansine, started October 2018","sponsor":"National Cancer Institute (NCI)","started":"2018-10-04","startedType":"actual","yearReported":2024,"enrolled":49,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase I - Recommended Phase 2 Dose of Ametumab Ravtansine With Combination of Pembrolizumab","primary":true,"unit":"mg/kg iv","arms":[{"name":"Phase 1 Cohort: Anetumab Ravtansine & MK-3475","n":13,"value":6.5,"note":"Figures from the ClinicalTrials.gov results section (first posted 2024-10-16), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03126630?tab=results"},{"endpoint":"Phase 2 Overall Survival","unit":"participants","arms":[{"name":"Group I (Pembrolizumab)","n":17,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2024-10-16), not from a publication"},{"name":"Group II (Anetumab Ravtansine, Pembrolizumab)","n":18,"value":2}],"source":"https://clinicaltrials.gov/study/NCT03126630?tab=results"},{"endpoint":"Phase 2 Progression Free Survival","unit":"participants","arms":[{"name":"Group I (Pembrolizumab)","n":17,"value":10,"note":"Figures from the ClinicalTrials.gov results section (first posted 2024-10-16), not from a publication"},{"name":"Group II (Anetumab Ravtansine, Pembrolizumab)","n":18,"value":9}],"hr":1.81,"ci":[0.73,4.51],"p":"0.1952","source":"https://clinicaltrials.gov/study/NCT03126630?tab=results"}]},{"id":"nct06230471","kind":"trial","name":"Pembrolizumab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of pembrolizumab, gemcitabine, oxaliplatin and lenvatinib in gallbladder cancer and other biliary tract cancers, run by Peking Union Medical College Hospital, now recruiting.","summary":"Pembrolizumab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer is a phase 2, randomised interventional study registered as NCT06230471 by Peking Union Medical College Hospital, with a registry enrolment figure of 60 participants, started 2023-01-09 and due to reach its primary completion in 2025-12-31. Interventions recorded: Pembrolizumab,Lenvatinib and Gemox Chemotherapy（Gemcitabine and Oxaliplatin）, Pembrolizumab and Lenvatinib, Pembrolizumab and Gemox Chemotherapy（Gemcitabine and Oxaliplatin）. Conditions listed: Biliary Tract Neoplasms Immunotherapy. Gallbladder cancer is named in the registry entry: \"* They have histologically confirmed unresectable advanced or metastatic biliary tract adenocarcinoma, including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer.\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06230471","url":"https://clinicaltrials.gov/study/NCT06230471"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","kinase-inhibitors"],"targets":[],"drugs":["pembrolizumab","gemcitabine","oxaliplatin","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06230471","phase":"2","setting":"A Phase II, Multicenter, Randomized Study of Pembrolizumab With or Without Chemotherapy or Lenvatinib in First-Line Treatment of Advanced Biliary Tract Cancer","sponsor":"Peking Union Medical College Hospital","started":"2023-01-09","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06422143","kind":"trial","name":"Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-287","aka":[],"tldr":"A phase 3 trial of Pembrolizumab, Sacituzumab tirumotecan, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023] is a phase 3 interventional study registered as NCT06422143 by Merck Sharp & Dohme LLC, with 851 participants planned, started 2024-06-10 and due to reach its primary completion in 2029-01-12. Interventions recorded: Pembrolizumab, sac-TMT, Carboplatin, Paclitaxel, Nab-paclitaxel. Conditions listed: Non-small Cell Lung Cancer, NSCLC. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06422143","url":"https://clinicaltrials.gov/study/NCT06422143"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["adc","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["pembrolizumab","sacituzumab-tirumotecan","carboplatin","paclitaxel"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06422143","phase":"3","setting":"Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer","sponsor":"Merck Sharp & Dohme LLC","started":"2024-06-10","startedType":"actual","enrolled":851,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02263508","kind":"trial","name":"Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma","aka":["MASTERKEY-265"],"tldr":"A phase 3 trial of Talimogene laherparepvec and Pembrolizumab in Melanoma, run by Amgen, recorded as terminated on the registry.","summary":"Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma is a phase 3 interventional study registered as NCT02263508 by Amgen, with 713 participants recorded, started 2014-12-08 and due to reach its primary completion in 2021-03-11. Interventions recorded: Talimogene Laherparepvec, Pembrolizumab, Placebo. Conditions recorded: Melanoma.\n\nLinked to the drug Talimogene laherparepvec because the registry names it among its interventions and Melanoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02263508","url":"https://clinicaltrials.gov/study/NCT02263508"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["talimogene-laherparepvec","pembrolizumab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02263508","phase":"3","setting":"A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265)","sponsor":"Amgen","started":"2014-12-08","startedType":"actual","yearReported":2022,"enrolled":713,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase 3: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessed Using Modified RECIST 1.1","primary":true,"unit":"months","arms":[{"name":"Phase 3: Placebo + Pembrolizumab","n":346,"value":8.5,"note":"95% CI 5.72 to 13.54; Figures from the ClinicalTrials.gov results section (first posted 2022-05-16), not from a publication"},{"name":"Phase 3: Talimogene Laherparepvec + Pembrolizumab","n":346,"value":14.3,"note":"95% CI 10.25 to 22.11"}],"hr":0.86,"ci":[0.71,1.04],"p":"0.13","source":"https://clinicaltrials.gov/study/NCT02263508?tab=results"},{"endpoint":"Phase 1b: Objective Response Rate (ORR)","unit":"%","arms":[{"name":"Phase 1b: Talimogene Laherparepvec + Pembrolizumab","n":21,"value":61.9,"note":"95% CI 38.4 to 81.9; Figures from the ClinicalTrials.gov results section (first posted 2022-05-16), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT02263508?tab=results"}]},{"id":"nct05224141","kind":"trial","name":"Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)","aka":["KEYVIBE-008"],"tldr":"A phase 3 trial of Pembrolizumab, Etoposide, Cisplatin, Atezolizumab and Carboplatin in small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008) is a phase 3 interventional study registered as NCT05224141 by Merck Sharp & Dohme LLC, with 460 participants enrolled, started 2022-03-24 and due to reach its primary completion in 2024-06-04. Interventions recorded: Pembrolizumab/Vibostolimab Co-Formulation, Saline placebo, Etoposide, Cisplatin, Atezolizumab and Carboplatin. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05224141","url":"https://clinicaltrials.gov/study/NCT05224141"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["pembrolizumab","etoposide","cisplatin","atezolizumab","carboplatin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05224141","phase":"3","setting":"A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination With Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination With Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer (KEYVIBE-008)","sponsor":"Merck Sharp & Dohme LLC","started":"2022-03-24","startedType":"actual","yearReported":2025,"enrolled":460,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab/Vibostolimab","n":230,"value":11.5,"note":"95% CI 9.8 to 12.6; Figures from the ClinicalTrials.gov results section (first posted 2025-05-30), not from a publication"},{"name":"Atezolizumab","n":230,"value":12.9,"note":"95% CI 11.6 to 14.8"}],"hr":1.26,"ci":[1,1.59],"p":"0.9762","source":"https://clinicaltrials.gov/study/NCT05224141?tab=results"},{"endpoint":"Progression-Free Survival (PFS)","unit":"months","arms":[{"name":"Pembrolizumab/Vibostolimab","n":230,"value":5.3,"note":"95% CI 4.4 to 5.4; Figures from the ClinicalTrials.gov results section (first posted 2025-05-30), not from a publication"},{"name":"Atezolizumab","n":230,"value":4.5,"note":"95% CI 4.4 to 5.3"}],"hr":1.01,"ci":[0.82,1.23],"p":"0.5316","source":"https://clinicaltrials.gov/study/NCT05224141?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"Pembrolizumab/Vibostolimab","n":230,"value":71.7,"note":"95% CI 65.4 to 77.5; Figures from the ClinicalTrials.gov results section (first posted 2025-05-30), not from a publication"},{"name":"Atezolizumab","n":230,"value":74.8,"note":"95% CI 68.7 to 80.3"}],"source":"https://clinicaltrials.gov/study/NCT05224141?tab=results"}]},{"id":"nct06530823","kind":"trial","name":"Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma","aka":[],"tldr":"A phase 2 trial of durvalumab and pemigatinib in gallbladder cancer and other biliary tract cancers, run by Eastern Hepatobiliary Surgery Hospital, not yet recruiting.","summary":"Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma is a phase 2 interventional study registered as NCT06530823 by Eastern Hepatobiliary Surgery Hospital, with a registry enrolment figure of 38 participants, started 2024-08-01 and due to reach its primary completion in 2026-08-01. Interventions recorded: Pemigatinib and Durvalumab. Conditions listed: Biliary Tract Carcinoma, Cholangiocarcinoma. Gallbladder cancer is named in the registry entry: \"3. Histologically confirmed advanced gallbladder cancer or cholangiocarcinoma patients who have received one prior line of therapy;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06530823","url":"https://clinicaltrials.gov/study/NCT06530823"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["durvalumab","pemigatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06530823","phase":"2","setting":"Pemigatinib Combined With Durvalumab for the Safety and Efficacy in Second-Line Treatment of Biliary Tract Cancer: A Single-Arm, Multicenter Phase II Clinical Trial","sponsor":"Eastern Hepatobiliary Surgery Hospital","started":"2024-08-01","startedType":"estimated","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07786766","kind":"trial","name":"Pemigatinib Plus PD-1 Inhibitor With or Without Chemotherapy in FGFR2 Fusion/Rearrangement-Positive Cholangiocarcinoma","aka":[],"tldr":"A phase 2 trial of pemigatinib in gallbladder cancer and other biliary tract cancers, run by Haitao Zhao, MD, now recruiting.","summary":"Pemigatinib Plus PD-1 Inhibitor With or Without Chemotherapy in FGFR2 Fusion/Rearrangement-Positive Cholangiocarcinoma is a phase 2 interventional study registered as NCT07786766 by Haitao Zhao, MD, with a registry enrolment figure of 154 participants, started 2026-08-20 and due to reach its primary completion in 2027-12-31. Interventions recorded: Pemigatinb, PD-1 inhibitors, Chemotherapy. Conditions listed: Biliary Tract Cancer (BTC). Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07786766","url":"https://clinicaltrials.gov/study/NCT07786766"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["pemigatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07786766","phase":"2","setting":"An Open-Label, Phase II Clinical Study Evaluating the Efficacy and Safety of Pemigatinib in Combination With a PD-1 Inhibitor, With or Without Chemotherapy, in Patients With Unresectable or Metastatic Cholangiocarcinoma Harboring FGFR2 Fusions or Rearrangements","sponsor":"Haitao Zhao, MD","started":"2026-08-20","startedType":"actual","enrolled":154,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04695782","kind":"trial","name":"Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy","aka":["ReRad II"],"tldr":"A phase 2 trial in colorectal cancer, run by University of Aarhus, now recruiting.","summary":"Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy is a phase 2, interventional study registered as NCT04695782 by University of Aarhus, with a registry enrolment figure of 65 participants, started 2020-10-10 and due to reach its primary completion in 2025-10-31. Interventions recorded: Pencil beam proton radiotherapy. Conditions listed: Rectal Cancer Recurrent. Primary outcome: R0-resection; 1-year local control. Colorectal eligibility wording from the registry: \"* • Locally recurrent rectal cancer\". Sites: Denmark. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04695782","url":"https://clinicaltrials.gov/study/NCT04695782"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04695782","phase":"2","setting":"Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy","sponsor":"University of Aarhus","started":"2020-10-10","startedType":"actual","enrolled":65,"enrolledBasis":"registry","outcomes":[]},{"id":"penelope-b","kind":"trial","name":"PENELOPE-B","aka":[],"tldr":"PENELOPE-B tested whether a year of the CDK4/6 inhibitor palbociclib after chemotherapy and surgery would prevent recurrence in women at high risk; it did not, one of two trials to show that palbociclib does not work in early breast cancer even though later drugs in the class do.","summary":"PENELOPE-B randomised 1250 women with hormone receptor-positive, HER2-negative breast cancer who still had invasive disease at surgery after neoadjuvant chemotherapy, and a high clinical-pathological risk score, to 13 cycles of palbociclib or placebo alongside standard endocrine therapy. The primary endpoint was invasive disease-free survival.\n\nPalbociclib did not improve invasive disease-free survival; an early separation of the curves disappeared with longer follow-up. Together with PALLAS, which tested two years of palbociclib in a broader population, it showed that palbociclib has no role in early breast cancer, while abemaciclib (monarchE) and ribociclib (NATALEE) proved effective, a reminder that the class does not behave as one drug.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01864746","url":"https://clinicaltrials.gov/study/NCT01864746"}],"tags":["subtype-trials"],"related":[],"cancers":["hr-positive-early-high-risk","breast-hr-positive","breast-cancer"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["palbociclib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sibylle-loibl"],"bottlenecks":[],"keyPapers":["paper-penelope-b-j-clin-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01864746","phase":"3","setting":"Hormone receptor-positive, HER2-negative early breast cancer with residual disease and high risk of relapse after neoadjuvant chemotherapy: one year of palbociclib or placebo added to endocrine therapy","sponsor":"German Breast Group (GBG Forschungs GmbH)","result":"One year of palbociclib added to endocrine therapy did not improve invasive disease-free survival.","started":"2013-10-30","startedType":"actual","yearReported":2021,"enrolled":1250,"enrolledBasis":"registry","outcomes":[{"endpoint":"Invasive disease-free survival","primary":true,"arms":[{"name":"Palbociclib + endocrine therapy","note":"Stratified hazard ratio with 95% repeated CI; 1250 randomised; 308 events; median follow-up 42.8 months"},{"name":"Placebo + endocrine therapy"}],"hr":0.93,"ci":[0.74,1.17],"p":"0.525","source":"https://doi.org/10.1200/jco.20.03639"}]},{"id":"nct04846634","kind":"trial","name":"Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (A","aka":["ALTER-L043"],"tldr":"A phase 2 trial of penpulimab, cisplatin, carboplatin, pemetrexed and other drugs in lung cancer, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043) is a phase 2, randomised interventional study registered as NCT04846634 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 90 participants, started 2021-08 and due to reach its primary completion in 2023-03. Interventions recorded: Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel; Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel; Penpulimab+Anlotinib. Conditions listed: Resectable Locally Advanced Non-small Cell Lung Cancer. Primary outcome: Major pathological response (MPR). Lung eligibility wording from the registry: \"* Early stage IIB-IIIB (N2), operable non-small cell lung cancer, confirmed in tissue\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04846634","url":"https://clinicaltrials.gov/study/NCT04846634"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","cytotoxic-chemotherapy","kinase-inhibitors","platinum"],"targets":[],"drugs":["penpulimab","cisplatin","carboplatin","pemetrexed","paclitaxel","gemcitabine","docetaxel","anlotinib"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04846634","phase":"2","setting":"Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043)","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2021-08","startedType":"estimated","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05950139","kind":"trial","name":"Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC","aka":["ARCHER"],"tldr":"A phase 1/2 trial in lung cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, now recruiting.","summary":"Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC is a phase 1/2, interventional study registered as NCT05950139 by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, with a registry enrolment figure of 12 participants, started 2024-05-13 and due to reach its primary completion in 2027-07. Interventions recorded: Peptide vaccine. Conditions listed: NSCLC Stage IV; ALK Fusion Protein Expression. Primary outcome: Incidence of treatment-related adverse events; Vaccine-specific immune response. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05950139","url":"https://clinicaltrials.gov/study/NCT05950139"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["alk-positive-nsclc"],"sections":[],"technologies":["shared-antigen-vaccine"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05950139","phase":"1/2","setting":"Pilot Study of a Prophylactic Cancer Peptide Vaccine in Advanced ALK+ NSCLC","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","started":"2024-05-13","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03659448","kind":"trial","name":"Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer","aka":[],"tldr":"A phase 3 trial testing SGM-101 in colorectal cancer, now recruiting.","summary":"Performance of SGM-101 for the Delineation of Primary and Recurrent Tumour and Metastases in Patients Undergoing Surgery for Colorectal Cancer is a phase 3 interventional study registered as NCT03659448, led by Surgimab, and recruiting on the registry. Official title: Multicenter, Open-label, Randomised, Controlled, Parallel Arms Clinical Study on Performance of SGM-101, a Fluorochrome-labeled Anti-CEA Monoclonal Antibody, for Delineation of Primary/Recurrent Tumour and Metastases in Patients Undergoing Surgery for Colorectal Cancer. Planned enrolment is 300 participants (estimated). The study started in 2019-06-17 and primary completion is expected in 2024-11. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT03659448","url":"https://clinicaltrials.gov/study/NCT03659448"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["sgm-101"],"companies":["surgimab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03659448","phase":"3","setting":"Multicenter, Open-label, Randomized, Controlled, Parallel Arms Clinical Study on Performance of SGM-101, a Fluorochrome-labeled Anti-CEA Monoclonal Antibody, for Delineation of Primary/Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer","sponsor":"Surgimab","started":"2019-06-17","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07450183","kind":"trial","name":"Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1","aka":[],"tldr":"A phase 2 trial of cemiplimab in lung cancer, run by Henry Ford Health System, not yet recruiting.","summary":"Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1 is a phase 2, interventional study registered as NCT07450183 by Henry Ford Health System, with a registry enrolment figure of 33 participants, started 2027-01-01 and due to reach its primary completion in 2027-12-01. Interventions recorded: Cemiplimab; Adjuvant chemotherapy. Conditions listed: Lung Cancer (NSCLC). Primary outcome: Pathologic Complete Response Rate. Lung eligibility wording from the registry: \"* Patient diagnosed with early-stage resectable stage II to IIIA squamous or non-squamous, operable treatment naïve NSCLC with PD-L1 TPS ≥50%\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07450183","url":"https://clinicaltrials.gov/study/NCT07450183"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07450183","phase":"2","setting":"Phase II Trial of Perioperative Cemiplimab in Patients With Resectable Non-small Cell Lung Cancer and PD-L1 ≥50%","sponsor":"Henry Ford Health System","started":"2027-01-01","startedType":"estimated","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06155383","kind":"trial","name":"Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.","aka":[],"tldr":"A phase 2 trial of Capecitabine, Oxaliplatin, Disitamab vedotin and Toripalimab in gastric & gastro-oesophageal junction cancer, run by RemeGen Co., Ltd., now recruiting.","summary":"Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma. is a phase 2 interventional study registered as NCT06155383 by RemeGen Co., Ltd., with 90 participants planned, started 2023-11-27 and due to reach its primary completion in 2025-01-31. Interventions recorded: Capecitabine, oxaliplatin, Disitamab Vedotin and Toripalimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06155383","url":"https://clinicaltrials.gov/study/NCT06155383"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["capecitabine","oxaliplatin","disitamab-vedotin","toripalimab"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06155383","phase":"2","setting":"A Phase II Study of Perioperative Disitamab Vedotin Plus Toripalimab and XELOX Versus Disitamab Vedotin Plus Toripalimab Versus XELOX in Subjects With HER2-expressing Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.","sponsor":"RemeGen Co., Ltd.","started":"2023-11-27","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06960577","kind":"trial","name":"Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)","aka":["NIAGARA-2"],"tldr":"A phase 3 trial of Durvalumab, Methotrexate, Vinblastine, Doxorubicin, Cisplatin and Gemcitabine in bladder & urothelial cancer, run by AstraZeneca, now recruiting.","summary":"Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2) is a phase 3 interventional study registered as NCT06960577 by AstraZeneca, with 150 participants planned, started 2025-05-15 and due to reach its primary completion in 2028-10-31. Interventions recorded: Durvalumab, Methotrexate, Vinblastine, Doxorubicin, Cisplatin and Gemcitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06960577","url":"https://clinicaltrials.gov/study/NCT06960577"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["durvalumab","methotrexate","vinblastine","doxorubicin","cisplatin","gemcitabine"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06960577","phase":"3","setting":"A Phase IIIb, Open-label, Single-arm, Global Study of Perioperative Durvalumab With Neoadjuvant ddMVAC or Gem/Cis in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)","sponsor":"AstraZeneca","started":"2025-05-15","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06001658","kind":"trial","name":"Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers","aka":[],"tldr":"A phase 2 trial of pembrolizumab, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, now recruiting.","summary":"Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers is a phase 2 interventional study registered as NCT06001658 by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, with a registry enrolment figure of 27 participants, started 2024-07-08 and due to reach its primary completion in 2028-06. Interventions recorded: Gemcitabine, Cisplatin, Pembrolizumab. Conditions listed: Billiary Track Cancer. Gallbladder cancer is named in the registry entry: \"* Must have a newly diagnosed, biopsy-proven biliary tract cancer (BTC) including gallbladder, intrahepatic, extrahepatic, and hilar cholangiocarcinoma.\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06001658","url":"https://clinicaltrials.gov/study/NCT06001658"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pembrolizumab","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06001658","phase":"2","setting":"Tumor Microenvironment Features of Response to Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","started":"2024-07-08","startedType":"actual","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05637567","kind":"trial","name":"Perioperative Platelet Inhibition With Acetylsalicylic Acid in Patients With Resectable Tumors of the Pancreatic Head","aka":["ASAP"],"tldr":"A phase 2 trial of aspirin in pancreatic cancer, run by German Cancer Research Center, not yet recruiting.","summary":"Perioperative Platelet Inhibition With Acetylsalicylic Acid in Patients With Resectable Tumors of the Pancreatic Head is a phase 2, randomised interventional study registered as NCT05637567 by German Cancer Research Center, with a registry enrolment figure of 170 participants, started 2024-04 and due to reach its primary completion in 2028-09. Interventions recorded: Acetylsalicylic acid; Placebo. Conditions listed: Pancreatic Cancer Resectable. Primary outcome: Hematogenous metastases-free survival. Pancreatic eligibility wording from the registry: \"Indication: Patients with (histologically confirmed or clinically suspected) surgically resectable, non-metastatic ductal adenocarcinoma of the pancreatic head\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05637567","url":"https://clinicaltrials.gov/study/NCT05637567"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["aspirin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05637567","phase":"2","setting":"Perioperative Platelet Inhibition With Acetylsalicylic Acid Targeting Intraoperative Tumor Cell Seeding in Patients With Resectable Tumors of the Pancreatic Head - a Randomized, Controlled Multicenter Study","sponsor":"German Cancer Research Center","started":"2024-04","startedType":"estimated","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02758951","kind":"trial","name":"Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases","aka":["CAIRO6"],"tldr":"A phase 2/3 trial in colorectal cancer, run by Koen Rovers, active but no longer recruiting.","summary":"Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases is a phase 2/3, randomised interventional study registered as NCT02758951 by Koen Rovers, with a registry enrolment figure of 358 participants, started 2017-06-01 and due to reach its primary completion in 2024-10-31. Interventions recorded: Perioperative systemic therapy; Perioperative CAPOX-bevacizumab; Perioperative FOLFOX-bevacizumab; Perioperative FOLFIRI-bevacizumab; CRS-HIPEC, experimental arm; CRS-HIPEC, control arm. Conditions listed: Colorectal Neoplasm; Colorectal Cancer; Colorectal Neoplasms Malignant; Colorectal Carcinoma; Colorectal Adenocarcinoma; Peritoneal Neoplasms; Peritoneal Carcinomatosis; Peritoneal Cancer; Peritoneal Metastases; Peritoneal Neoplasm Malignant Secondary Carcinomatosis; Peritoneal Neoplasm Malignant Secondary. Primary outcome: Overall survival. Colorectal eligibility wording from the registry: \"* histological or cytological proof of PM of a non-appendiceal colorectal adenocarcinoma with ≤50% of the tumour cells being signet ring cells;\". Sites: Belgium, Netherlands. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02758951","url":"https://clinicaltrials.gov/study/NCT02758951"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["hipec"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02758951","phase":"2/3","setting":"Perioperative Systemic Therapy and Cytoreductive Surgery With HIPEC Versus Upfront Cytoreductive Surgery With HIPEC Alone for Isolated Resectable Colorectal Peritoneal Metastases: a Multicentre, Open-label, Parallel-group, Phase II-III, Randomised Superiority Study","sponsor":"Koen Rovers","started":"2017-06-01","startedType":"actual","enrolled":358,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06210360","kind":"trial","name":"Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX","aka":[],"tldr":"A phase 2 trial of liposomal irinotecan, cAPOX (capecitabine, oxaliplatin), fluorouracil (5-FU) and leucovorin (folinic acid) in pancreatic cancer, run by Changhai Hospital, not yet recruiting.","summary":"Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX is a phase 2, randomised interventional study registered as NCT06210360 by Changhai Hospital, with a registry enrolment figure of 134 participants, started 2024-02-01 and due to reach its primary completion in 2025-04-01. Interventions recorded: Irinotecan liposome injection; Oxaliplatin; 5-FU; LV. Conditions listed: Pancreatic Cancer. Primary outcome: 2-year Overall Survival Rate. Pancreatic eligibility wording from the registry: \"Histologically or cytologically proven pancreatic ductal adenocarcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06210360","url":"https://clinicaltrials.gov/study/NCT06210360"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["liposomal-irinotecan","capox","fluorouracil","leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06210360","phase":"2","setting":"NALIRIFOX as Perioperative Treatment in Patients With High-risk Resectable Pancreatic Cancer : a Multicenter, Randomized, Open-label Trial","sponsor":"Changhai Hospital","started":"2024-02-01","startedType":"estimated","enrolled":134,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06864624","kind":"trial","name":"Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC","aka":["WU-KONG20"],"tldr":"A phase 2 trial of sunvozertinib in lung cancer, run by Tang-Du Hospital, now recruiting.","summary":"Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC is a phase 2, interventional study registered as NCT06864624 by Tang-Du Hospital, with a registry enrolment figure of 27 participants, started 2025-02-18 and due to reach its primary completion in 2026-12. Interventions recorded: Sunvozertinib. Conditions listed: NSCLC. Primary outcome: Objective response rate (ORR) of neoadjuvant therapy. Lung eligibility wording from the registry: \"Non-small cell lung cancer confirmed by histopathology or cytology, clinical stage II, IIIA or IIIB (N2) assessed by the investigator according to AJCC 8th edition\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06864624","url":"https://clinicaltrials.gov/study/NCT06864624"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["sunvozertinib"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06864624","phase":"2","setting":"Sunvozertinib as Neoadjuvant and Adjuvant Therapy in Stage II-IIIB Non-small-cell Lung Cancer Patients With EGFR Exon 20 Insertion Mutation: a Single-arm, Phase 2 Study (WU-KONG20)","sponsor":"Tang-Du Hospital","started":"2025-02-18","startedType":"actual","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03125980","kind":"trial","name":"Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer","aka":[],"tldr":"A phase 3 trial of capecitabine in colorectal cancer, run by Fudan University, now recruiting.","summary":"Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer is a phase 3, randomised interventional study registered as NCT03125980 by Fudan University, with a registry enrolment figure of 1370 participants, started 2017-05 and due to reach its primary completion in 2022-05. Interventions recorded: capecitabine plus oxaliplatin before and after surgery; capecitabine plus oxaliplatin after surgery. Conditions listed: Locally Advanced Colon Cancer. Primary outcome: 3-year disease free survival. Colorectal eligibility wording from the registry: \"* No previous systemic chemotherapy for treating colon cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03125980","url":"https://clinicaltrials.gov/study/NCT03125980"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03125980","phase":"3","setting":"Perioperative CapeOX Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Resectable Colon Cancer: An Open Label Randomized Controlled Phase III Trial","sponsor":"Fudan University","started":"2017-05","startedType":"estimated","enrolled":1370,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07458204","kind":"trial","name":"Peritumoral and Periganglionic Infiltration of Levobupivacaine Prior to Conservative Surgery for Triple-negative Breast Cancer","aka":["EPPIL"],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Institut Jean-Godinot, not yet recruiting.","summary":"Peritumoral and Periganglionic Infiltration of Levobupivacaine Prior to Conservative Surgery for Triple-negative Breast Cancer is a phase 2, randomised interventional study registered as NCT07458204 by Institut Jean-Godinot, with a registry enrolment figure of 760 participants, started 2026-10-01 and due to reach its primary completion in 2031-10-01. Interventions recorded: LVB infiltration. Conditions listed: Triple-negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* with histologically confirmed triple-negative breast cancer\". Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07458204","url":"https://clinicaltrials.gov/study/NCT07458204"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07458204","phase":"2","setting":"Peritumoral and Periganglionic Infiltration of Levobupivacaine Prior to Conservative Surgery for Triple-negative Breast Cancer","sponsor":"Institut Jean-Godinot","started":"2026-10-01","startedType":"estimated","enrolled":760,"enrolledBasis":"registry","outcomes":[]},{"id":"lidocaine-peritumoral-tmh","kind":"trial","name":"Peritumoral lidocaine before breast cancer surgery (Tata Memorial)","aka":[],"tldr":"Injecting a common local anaesthetic around the tumour minutes before surgery cut the risk of recurrence and death in a 1,583-woman Indian trial, at almost no cost.","summary":"1,583 women with early breast cancer were randomised to peritumoral lidocaine (n=796) or no injection (n=804) before surgery. At 5 years disease-free survival was 86.6% versus 82.6% (hazard ratio 0.74; P=0.017), overall survival 90.1% versus 86.4% (hazard ratio 0.71; P=0.019) and distant recurrence 8.5% versus 11.6% (hazard ratio 0.73), with no adverse events from the intervention. The proposed mechanism is blockade of voltage-gated sodium channels and surgery-induced tumour cell activation and dissemination. Confirmation in other populations is awaited before guideline adoption, but the trial is a model of the cheap, mechanism-led perioperative interventions Tata Memorial has pursued for two decades.","status":"positive","asOf":"2026-09-10","links":[{"label":"Badwe et al., JCO 2023","url":"https://doi.org/10.1200/JCO.22.01966"}],"tags":[],"related":[],"cancers":["breast-hr-positive","tnbc","breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":["os"],"trials":[],"people":["badwe-rajendra"],"bottlenecks":["b-generic-repurposing","b-surgery-radiation-innovation","b-metastasis-biology"],"keyPapers":["paper-badwe-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Early breast cancer: peritumoral infiltration of 0.5% lidocaine immediately before surgery vs surgery alone","sponsor":"Tata Memorial Centre","result":"5-year DFS 86.6% vs 82.6% (HR 0.74); OS 90.1% vs 86.4% (HR 0.71).","yearReported":2023,"enrolled":1583,"enrolledBasis":"registry","outcomes":[{"endpoint":"5-year disease-free survival","primary":true,"unit":"%","arms":[{"name":"Peritumoral lidocaine","n":796,"value":86.6},{"name":"No lidocaine","n":804,"value":82.6}],"hr":0.74,"p":"0.017","source":"https://doi.org/10.1200/JCO.22.01966"},{"endpoint":"5-year overall survival","unit":"%","arms":[{"name":"Peritumoral lidocaine","value":90.1},{"name":"No lidocaine","value":86.4}],"hr":0.71,"p":"0.019","source":"https://doi.org/10.1200/JCO.22.01966"}]},{"id":"persephone","kind":"trial","name":"PERSEPHONE","aka":[],"tldr":"Six months of trastuzumab was almost as good as twelve, with half the heart toxicity, though twelve remains the global standard.","summary":"PERSEPHONE, trial NCT00712140 sponsored by Cancer Research UK and reported in 2019, showed that six months of adjuvant trastuzumab for HER2-positive early breast cancer was almost as good as twelve, with half the heart toxicity, though twelve months remains the global standard. It randomised 4,088 women and met its non-inferiority endpoint on four-year disease-free survival, with cardiac events requiring discontinuation in four percent against eight percent. OnCo links it to trastuzumab, the trastuzumab cardiotoxicity term, Helena Earl, Judith M. Bliss, Andrew Wardley, the bottleneck of wrong doses and the idea of funding trials of shorter courses of expensive adjuvant drugs. The other shorter-duration trials PHARE, SOLD and Short-HER did not establish non-inferiority, so most guidelines retain twelve months while accepting six where resources are limited.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00712140","url":"https://clinicaltrials.gov/study/NCT00712140"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["trastuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":["trastuzumab-cardiotoxicity"],"trials":[],"people":["helena-earl","judith-bliss","andrew-wardley"],"bottlenecks":[],"keyPapers":["paper-persephone-lancet-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00712140","phase":"3","setting":"Adjuvant HER2+ early breast cancer: 6 vs 12 months of trastuzumab","sponsor":"Cancer Research UK","result":"4-year DFS 89.4% vs 89.8%, non-inferior.","started":"2007-10","yearReported":2019,"enrolled":4088,"enrolledBasis":"registry","outcomes":[{"endpoint":"4-year disease-free survival","primary":true,"unit":"%","arms":[{"name":"6 months trastuzumab","n":2043,"value":89.4},{"name":"12 months trastuzumab","n":2045,"value":89.8}],"hr":1.07,"ci":[0.93,1.24],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)30650-6/fulltext"}],"replication":"PHARE, SOLD, Short-HER did not establish non-inferiority; pooled analyses suggest a small loss with shorter therapy in higher-risk disease."},{"id":"perseus","kind":"trial","name":"PERSEUS","aka":[],"tldr":"Adding daratumumab to the standard three-drug induction and to maintenance cut the risk of progression by more than half in transplant-eligible myeloma.","summary":"PERSEUS, trial NCT03710603 sponsored by the European Myeloma Network and Janssen and published in the New England Journal of Medicine in 2024, showed that adding daratumumab to bortezomib, lenalidomide and dexamethasone induction and to lenalidomide maintenance cut the risk of progression by more than half in transplant-eligible newly diagnosed myeloma. It randomised 709 patients, met its primary progression-free survival endpoint at 48 months with far higher and more sustained MRD negativity, and led to approval in July 2024, with daratumumab stopped after sustained MRD negativity in the experimental arm, embedding MRD-guided de-escalation. Whether transplant is still needed on top of a quadruplet is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03710603","url":"https://clinicaltrials.gov/study/NCT03710603"},{"label":"NEJM 2024","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2312054"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-transplant-eligible"],"sections":[],"technologies":["autologous-stem-cell-transplant"],"targets":[],"drugs":["daratumumab","bortezomib","lenalidomide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["mrd-negativity-myeloma"],"trials":[],"people":["pieter-sonneveld"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03710603","phase":"3","setting":"Newly diagnosed transplant-eligible myeloma: Dara-VRd induction/consolidation + DR maintenance vs VRd + R","sponsor":"EMN / Janssen","result":"PFS HR 0.42; 48-month PFS 84.3% vs 67.7%.","started":"2018-12-14","startedType":"actual","yearReported":2023,"enrolled":709,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 48 months","primary":true,"unit":"%","arms":[{"name":"Dara-VRd","n":355,"value":84.3},{"name":"VRd","n":354,"value":67.7}],"hr":0.42,"ci":[0.3,0.59],"p":"<0.0001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2312054"},{"endpoint":"MRD negativity (10⁻⁵)","unit":"%","arms":[{"name":"Dara-VRd","value":75.2},{"name":"VRd","value":47.5}],"source":"https://doi.org/10.1056/NEJMoa2312054"}],"replication":"Consistent with GRIFFIN (phase 2) and with CASSIOPEIA (Dara-VTd); Isa-VRd in IsKia and IMROZ show the same class effect."},{"id":"persevera","kind":"trial","name":"persevERA","aka":[],"tldr":"An oral SERD did not beat the aromatase inhibitor in first-line treatment when both were combined with palbociclib. Oral SERDs earn their place after resistance, not before it.","summary":"persevERA, trial NCT04546009 sponsored by Roche and Genentech and reported in 2026, found that the oral SERD giredestrant did not beat letrozole in first-line treatment of ER-positive, HER2-negative advanced breast cancer when both were combined with palbociclib, suggesting oral SERDs earn their place after resistance rather than before it. It randomised 978 women, and its primary endpoint of investigator-assessed progression-free survival was not met, as announced on 9 March 2026 and presented at ASCO 2026, with a numerical improvement of about eleven percent that was not significant. OnCo links it to giredestrant and palbociclib. Whether an ESR1-selected first-line strategy would fare differently is the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04546009","url":"https://clinicaltrials.gov/study/NCT04546009"}],"tags":["failure","lesson:selection"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["giredestrant","palbociclib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04546009","phase":"3","setting":"First-line ER+/HER2- advanced breast cancer: giredestrant + palbociclib vs letrozole + palbociclib","sponsor":"Roche / Genentech","result":"PFS 33.1 vs 28.2 months, not significant.","started":"2020-10-09","startedType":"actual","yearReported":2026,"enrolled":992,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (investigator)","primary":true,"unit":"months","arms":[{"name":"Giredestrant + palbociclib","value":33.1},{"name":"Letrozole + palbociclib","value":28.2}],"source":"https://www.roche.com/media/releases/med-cor-2026-03-09"}],"replication":"Consistent with the null result of first-line oral SERD strategies without ESR1 selection (e.g., SERENA-4 pending); contrasts with the adjuvant lidERA success."},{"id":"nct06631079","kind":"trial","name":"Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Anti-PD-1/PD-L1 Therapy in Patients With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of NECVAX-NEO1 in advanced solid tumours, run by NEC Bio B.V, active and no longer recruiting.","summary":"Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Anti-PD-1/PD-L1 Therapy in Patients With Solid Tumors is a phase 1/2 interventional study registered as NCT06631079 by NEC Bio B.V, with 20 participants enrolled, started 2024-10-07 and due to reach its primary completion in 2026-07-31. Interventions recorded: NECVAX-NEO1.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06631079","url":"https://clinicaltrials.gov/study/NCT06631079"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["pd1","pdl1"],"drugs":[],"companies":["nec-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06631079","phase":"1/2","setting":"An Open-label, Phase I/II Multicenter Clinical Trial of NECVAX-NEO1 in Addition to Anti-PD-1 or Anti-PD-L1 Monoclonal Antibody Therapy in Patients With Solid Tumors","sponsor":"NEC Bio B.V","started":"2024-10-07","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06631092","kind":"trial","name":"Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Neoadjuvant Triple-negative Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of Oral DNA Vaccine in triple-negative breast cancer, run by NEC Bio B.V, now recruiting.","summary":"Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Neoadjuvant Triple-negative Breast Cancer is a phase 1/2 interventional study registered as NCT06631092 by NEC Bio B.V, with 28 participants planned, started 2024-11-20 and due to reach its primary completion in 2027-12-31. Interventions recorded: Oral DNA Vaccine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06631092","url":"https://clinicaltrials.gov/study/NCT06631092"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":[],"targets":["pd1"],"drugs":[],"companies":["nec-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06631092","phase":"1/2","setting":"An Open-label, Phase I/II Multicenter Clinical Trial of NECVAX-NEO1 as add-on to First-line Neoadjuvant Anti-PD-1 Monoclonal Antibody Therapy in Patients With Triple-negative Breast Cancer","sponsor":"NEC Bio B.V","started":"2024-11-20","startedType":"actual","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06293625","kind":"trial","name":"Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced but Resecable Colon Cancer in the Elderly of 70 Years Old or More","aka":["FOxTROT2France"],"tldr":"A phase 3 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Centre Hospitalier Universitaire Dijon, now recruiting.","summary":"Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced but Resecable Colon Cancer in the Elderly of 70 Years Old or More is a phase 3, randomised interventional study registered as NCT06293625 by Centre Hospitalier Universitaire Dijon, with a registry enrolment figure of 150 participants, started 2024-06-07 and due to reach its primary completion in 2032-06. Interventions recorded: Folfox; Surgery. Conditions listed: Colon Cancer. Primary outcome: DFS (disease Free Survival). Colorectal eligibility wording from the registry: \"* Biopsy-confirmed adenocarcinoma of the colon (or upper rectum if too high for radiotherapy), high-grade dysplasia is not acceptable ,\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06293625","url":"https://clinicaltrials.gov/study/NCT06293625"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06293625","phase":"3","setting":"Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced but Resecable Colon Cancer in the Elderly of 70 Years Old or More Phase III Multicentric Open-label Randomized Controlled Trial","sponsor":"Centre Hospitalier Universitaire Dijon","started":"2024-06-07","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04585490","kind":"trial","name":"Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC","aka":[],"tldr":"A phase 3 trial of durvalumab, carboplatin, pemetrexed, paclitaxel / nab-paclitaxel and other drugs in lung cancer, run by Maximilian Diehn, now recruiting.","summary":"Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC is a phase 3, interventional study registered as NCT04585490 by Maximilian Diehn, with a registry enrolment figure of 48 participants, started 2021-08-25 and due to reach its primary completion in 2026-08. Interventions recorded: Durvalumab; Carboplatin; Pemetrexed; Paclitaxel; Cisplatin; AVENIO ctDNA Surveillance Kit; Tremelimumab. Conditions listed: Non Small Cell Lung Cancer; NSCLC, Stage III; Nsclc. Primary outcome: Change in ctDNA Level Following Chemotherapy. Lung eligibility wording from the registry: \"Histologically- or cytologically-documented NSCLC presenting with locally-advanced, unresectable stage III disease (Version 8 of AJCC Staging Manual) or NSCLC with locoregional recurrence after previous definitive treatment\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04585490","url":"https://clinicaltrials.gov/study/NCT04585490"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","mrd-testing","platinum"],"targets":[],"drugs":["durvalumab","carboplatin","pemetrexed","paclitaxel","cisplatin","tremelimumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04585490","phase":"3","setting":"Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC","sponsor":"Maximilian Diehn","started":"2021-08-25","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07020247","kind":"trial","name":"Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for LARC: PALACE Study","aka":["PALACE"],"tldr":"A phase 3 trial in colorectal cancer, run by West China Hospital, now recruiting.","summary":"Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for LARC: PALACE Study is a phase 3, randomised interventional study registered as NCT07020247 by West China Hospital, with a registry enrolment figure of 184 participants, started 2024-11-19 and due to reach its primary completion in 2027-07-31. Interventions recorded: Anti-PD-1 antibody drug named Serplulimab; Radiotherapy; Chemotherapy. Conditions listed: Locally Advanced Rectal Cancer (LARC); Immunotherapy; Radiotherapy; Total Neoadjuvant Therapy; Anal Function Preservation. Primary outcome: Complete response rate. Colorectal eligibility wording from the registry: \"Patients with stage II/III rectal cancer staged under MRI or endoscopic ultrasonography and have at least one risk factor: cT4a and invasion of intestinal lumen for more than 1/2 week (measured by MRI)；cT4b(resectable)；cT3c-d with EMVI+ (upper middle rectum)；cN2；MRF+ (≤2mm)；lower rectal cancer is lo\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07020247","url":"https://clinicaltrials.gov/study/NCT07020247"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07020247","phase":"3","setting":"Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for Locally Advanced Rectal Cancer：A Randomized Controlled Study (PALACE Study)","sponsor":"West China Hospital","started":"2024-11-19","startedType":"actual","enrolled":184,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07121595","kind":"trial","name":"Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial","aka":["PRECEDENT"],"tldr":"A phase 2 trial of Carboplatin, Cisplatin, Paclitaxel / nab-paclitaxel, Technetium-99m tilmanocept and Technetium Tc-99m sulfur colloid in Oral cavity cancer, run by University of Michigan Rogel Cancer Center, now recruiting.","summary":"Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial is a phase 2 interventional study registered as NCT07121595 by University of Michigan Rogel Cancer Center, with 50 participants planned, started 2025-07-17 and due to reach its primary completion in 2030-07-01. Interventions recorded: Biospecimen Collection, Carboplatin, Cisplatin, Computed Tomography, Modified Barium Swallow, Paclitaxel, Positron Emission Tomography, Questionnaire Administration, Radiation Therapy, Sentinel Lymph Node Biopsy, Single Photon Emission Computed Tomography, Technetium Tc 99m-labeled Tilmanocept, Technetium Tc-99m Sulfur Colloid. Conditions recorded: Oral Cavity Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8.\n\nLinked to the drug Technetium Tc-99m sulfur colloid because the registry names it among its interventions and Oral cavity cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07121595","url":"https://clinicaltrials.gov/study/NCT07121595"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["oral-cavity-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["carboplatin","cisplatin","paclitaxel","tilmanocept-tc99m","technetium-sulfur-colloid"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07121595","phase":"2","setting":"PRECEDENT: Pilot Phase II Study of Personalized Radiation to the Contralateral Neck Directed by Sentinel Node Evaluation in Lateralized Oral Cavity Squamous Cell Carcinoma","sponsor":"University of Michigan Rogel Cancer Center","started":"2025-07-17","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07002203","kind":"trial","name":"Personalized Neoantigen Peptide Vaccines for Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Personalized Neoantigen Peptide Vaccine in advanced solid tumours, run by Seqker Biosciences, Inc., now recruiting.","summary":"Personalized Neoantigen Peptide Vaccines for Solid Tumors is a phase 1/2 interventional study registered as NCT07002203 by Seqker Biosciences, Inc., with 10 participants planned, started 2024-03-01 and due to reach its primary completion in 2027-08. Interventions recorded: Personalized Neoantigen Peptide Vaccine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07002203","url":"https://clinicaltrials.gov/study/NCT07002203"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07002203","phase":"1/2","setting":"A Phase Ib Clinical Study of Personalized Neoantigen Peptide Vaccines for Solid Tumors","sponsor":"Seqker Biosciences, Inc.","started":"2024-03-01","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05269381","kind":"trial","name":"Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors","aka":["PNeoVCA"],"tldr":"A phase 1/2 trial of cyclophosphamide, pembrolizumab and sargramostim in triple-negative breast cancer, run by Mayo Clinic, now recruiting.","summary":"Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors is a phase 1/2, interventional study registered as NCT05269381 by Mayo Clinic, with a registry enrolment figure of 138 participants, started 2022-03-31 and due to reach its primary completion in 2028-03-31. Interventions recorded: Cyclophosphamide; Neoantigen Peptide Vaccine; Pembrolizumab; Sargramostim; Biospecimen Collection; Biopsy; Computed Tomography; Magnetic Resonance Imaging. Conditions listed: Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage III Merkel Cell Carcinoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IV Merkel Cell Carcinoma AJCC v8; Clinical Stage IVA Gastric Cancer AJCC v8; Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IVB Gastric Cancer AJCC v8; Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Locally Advanced Cervical Carcinoma; Locally Advanced Endometrial Carcinoma; Locally Advanced Gastric Adenocarcinoma; Locally Advanced Gastroesophageal Junction Adenocarcinoma; Locally Advanced Head and Neck Squamous Cell Carcinoma; Locally Advanced Hepatocellular Carcinoma; Locally Advanced Lung Non-Small Cell Carcinoma; Locally Advanced Malignant Solid Neoplasm; Locally Advanced Melanoma; Locally Advanced Merkel Cell Carcinoma; Locally Advanced Renal Cell Carcinoma; Locally Advanced Skin Squamous Cell Carcinoma; Locally Advanced Triple-Negative Breast Carcinoma; Locally Advanced Unresectable Breast Carcinoma; Locally Advanced Unresectable Cervical Carcinoma; Locally Advanced Unresectable Gastric Adenocarcinoma; Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma; Locally Advanced Unresectable Renal Cell Carcinoma; Locally Advanced Urothelial Carcinoma; Metastatic Cervical Carcinoma; Metastatic Endometrial Carcinoma; Metastatic Gastric Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Metastatic Head and Neck Squamous Cell Carcinoma; Metastatic Hepatocellular Carcinoma; Metastatic Lung Non-Small Cell Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Melanoma; Metastatic Merkel Cell Carcinoma; Metastatic Renal Cell Carcinoma; Metastatic Skin Squamous Cell Carcinoma; Metastatic Triple-Negative Breast Carcinoma; Metastatic Urothelial Carcinoma; Skin Squamous Cell Carcinoma; Stage III Cervical Cancer AJCC v8; Stage III Hepatocellular Carcinoma AJCC v8; Stage III Lung Cancer AJCC v8; Stage III Renal Cell Cancer AJCC v8; Stage IIIA Cervical Cancer AJCC v8; Stage IIIA Hepatocellular Carcinoma AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIA Uterine Corpus Cancer AJCC v8; Stage IIIB Cervical Cancer AJCC v8; Stage IIIB Hepatocellular Carcinoma AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIB Uterine Corpus Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IIIC Uterine Corpus Cancer AJCC v8; Stage IIIC1 Uterine Corpus Cancer AJCC v8; Stage IIIC2 Uterine Corpus Cancer AJCC v8; Stage IV Cervical Cancer AJCC v8; Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Stage IV Hepatocellular Carcinoma AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8; Stage IVA Cervical Cancer AJCC v8; Stage IVA Hepatocellular Carcinoma AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVA Uterine Corpus Cancer AJCC v8; Stage IVB Cervical Cancer AJCC v8; Stage IVB Hepatocellular Carcinoma AJCC v8; Stage IVB Lung Cancer AJCC v8; Stage IVB Uterine Corpus Cancer AJCC v8; Triple-Negative Breast Carcinoma; Unresectable Cervical Carcinoma; Unresectable Endometrial Carcinoma; Unresectable Gastric Adenocarcinoma; Unresectable Gastroesophageal Junction Adenocarcinoma; Unresectable Head and Neck Squamous Cell Carcinoma; Unresectable Hepatocellular Carcinoma; Unresectable Lung Non-Small Cell Carcinoma; Unresectable Malignant Solid Neoplasm; Unresectable Melanoma; Unresectable Merkel Cell Carcinoma; Unresectable Renal Cell Carcinoma; Unresectable Skin Squamous Cell Carcinoma; Unresectable Triple-Negative Breast Carcinoma; Unresectable Urothelial Carcinoma; Breast Adenocarcinoma; Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8; Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8; Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8; Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8; Invasive Breast Lobular Carcinoma. Triple-negative eligibility wording from the registry: \"PHASE II PRE-REGISTRATION COHORT 3 (TNBC) ONLY:\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05269381","url":"https://clinicaltrials.gov/study/NCT05269381"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["cyclophosphamide","pembrolizumab","sargramostim"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05269381","phase":"1/2","setting":"A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)","sponsor":"Mayo Clinic","started":"2022-03-31","startedType":"actual","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06888674","kind":"trial","name":"Personalized Tumor Neoantigen MRNA Therapy Adjuvant Treatment for Postoperative Pancreatic Cancer.","aka":[],"tldr":"A phase 1/2 trial of gemcitabine, capecitabine and sintilimab in pancreatic cancer, run by Zhejiang University, not yet recruiting.","summary":"Personalized Tumor Neoantigen MRNA Therapy Adjuvant Treatment for Postoperative Pancreatic Cancer. is a phase 1/2, interventional study registered as NCT06888674 by Zhejiang University, with a registry enrolment figure of 60 participants, started 2025-04-01 and due to reach its primary completion in 2027-04-01. Interventions recorded: individualized anti-tumor new antigen iNeo-Vac-R01 injection; Gemcitabine + Capecitabine; Sintilimab injection. Conditions listed: Pancreatic Cancer Resectable. Primary outcome: Occurence and frequence of AE and SAE. Pancreatic eligibility wording from the registry: \"* Diagnosed with resectable pancreatic cancer as assessed per the 2024 NCCN Clinical Practice Guidelines and willing to undergo radical surgery;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06888674","url":"https://clinicaltrials.gov/study/NCT06888674"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","capecitabine","sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06888674","phase":"1/2","setting":"Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen MRNA Therapy Combined with PD-1 Antibody and Chemotherapy As Adjuvant Treatment for Postoperative Pancreatic Cancer.","sponsor":"Zhejiang University","started":"2025-04-01","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06888648","kind":"trial","name":"Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.","aka":[],"tldr":"A phase 1/2 trial of sintilimab in pancreatic cancer, run by Zhejiang University, not yet recruiting.","summary":"Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer. is a phase 1/2, interventional study registered as NCT06888648 by Zhejiang University, with a registry enrolment figure of 30 participants, started 2025-04-01 and due to reach its primary completion in 2027-04-01. Interventions recorded: individualized anti-tumor new antigen iNeo-Vac-R01 injection; mFOLFIRINOX Treatment Regimen; Sintilimab injection. Conditions listed: Pancreatic Cancer Metastatic; Pancreatic Cancer Non-resectable. Primary outcome: Occurence and frequence of AE and SAE. Pancreatic eligibility wording from the registry: \"Evaluation as metastatic pancreatic cancer or postoperative recurrence according to the 2024 NCCN guidelines;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06888648","url":"https://clinicaltrials.gov/study/NCT06888648"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06888648","phase":"1/2","setting":"Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen MRNA Therapy in Combination with PD-1 Antibody and Chemotherapy for Advanced Pancreatic Cancer.","sponsor":"Zhejiang University","started":"2025-04-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06841159","kind":"trial","name":"Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) Combined With Anti-PD1，Chemotherapy and Target Therapy for Metastatic Colorectal Can","aka":["iPULSAR-CRC"],"tldr":"A phase 2 trial of sintilimab in colorectal cancer, run by Fudan University, now recruiting.","summary":"Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) Combined With Anti-PD1，Chemotherapy and Target Therapy for Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06841159 by Fudan University, with a registry enrolment figure of 116 participants, started 2024-03-01 and due to reach its primary completion in 2026-03-01. Interventions recorded: Ultra-fractionated radiation therapy; Sintilimab; Standard systemic therapy. Conditions listed: Microsatellite Stable Metastatic Colorectal Cancer. Primary outcome: Progression-Free Survival (PFS). Colorectal eligibility wording from the registry: \"* Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06841159","url":"https://clinicaltrials.gov/study/NCT06841159"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","sbrt"],"targets":[],"drugs":["sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06841159","phase":"2","setting":"Phase 2 Study of Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) Combined With Anti-PD1, Chemotherapy and Target Therapy for Metastatic Colorectal Cancer(iPULSAR-CRC)","sponsor":"Fudan University","started":"2024-03-01","startedType":"actual","enrolled":116,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07340567","kind":"trial","name":"Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test","aka":["CIRCULATEIII"],"tldr":"A phase 3 trial of capecitabine, fOLFOX (5-FU, leucovorin, oxaliplatin) and fOLFIRINOX / mFOLFIRINOX in colorectal cancer, run by UNICANCER, active but no longer recruiting.","summary":"Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test is a phase 3, randomised interventional study registered as NCT07340567 by UNICANCER, with a registry enrolment figure of 2450 participants, started 2026-07-20 and due to reach its primary completion in 2032-11-01. Interventions recorded: Capecitabine; Oxaliplatin; Folfirinox; FOLFOX regimen. Conditions listed: Colorectal Cancer. Primary outcome: Non-inferiority of 6-month CAPE vs 3-month CAPOX ACT in terms of 3-year Disease Free Survival ctDNA-negative cohort; Superiority of 6-month FOLFIRINOX vs 6-month FOLFOX ACT in terms of 3-year Disease Free Survival ctDNA-positive cohort. Colorectal eligibility wording from the registry: \"Histologically confirmed stage III pMMR/MSS colon and high rectum adenocarcinoma (T, N1 or N2, M0) excluding medium and low rectal cancers (≥12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery are still eligible), without gross or microscopic evidence of residual\". Sites: France, Sweden. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07340567","url":"https://clinicaltrials.gov/study/NCT07340567"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","mrd-testing","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["capecitabine","folfox","folfirinox"],"companies":["natera","unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07340567","phase":"3","setting":"Tailoring the Decision for Adjuvant Chemotherapy Using Circulating Tumour DNA, in Patients With Stage III Colorectal Cancer","sponsor":"UNICANCER","started":"2026-07-20","startedType":"actual","enrolled":2450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06606730","kind":"trial","name":"Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer","aka":["OPT-PEMBRO"],"tldr":"A phase 3 trial of pembrolizumab in triple-negative breast cancer, run by UNICANCER, now recruiting.","summary":"Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer is a phase 3, randomised interventional study registered as NCT06606730 by UNICANCER, with a registry enrolment figure of 2454 participants, started 2025-07-23 and due to reach its primary completion in 2033-01-01. Interventions recorded: Pembrolizumab; Deescalation. Conditions listed: Breast Cancers; Triple Negative Breast Cancer (TNBC). Triple-negative eligibility wording from the registry: \"Estrogen receptor (ER) and Progesterone receptor (PR) ≤10%; HER2-negative as per ASCO/CAP guidelines Note: In case of bilateral breast cancer, participation in the study is permitted as long as both tumours are triple negative;\". Sites: Belgium, France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06606730","url":"https://clinicaltrials.gov/study/NCT06606730"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06606730","phase":"3","setting":"OPTimizing Adjuvant Prescription of PEMBROlizumab in Patients With Early-stage Triple-negative Breast Cancer Achieving Pathologic Complete Response After Standard Neoadjuvant Chemotherapy and Pembrolizumab","sponsor":"UNICANCER","started":"2025-07-23","startedType":"actual","enrolled":2454,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06245889","kind":"trial","name":"PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC","aka":["NeoADAPT"],"tldr":"A phase 2 trial of paclitaxel / nab-paclitaxel, carboplatin, pembrolizumab, doxorubicin and other drugs in triple-negative breast cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, now recruiting.","summary":"PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC is a phase 2, interventional study registered as NCT06245889 by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, with a registry enrolment figure of 30 participants, started 2024-05-01 and due to reach its primary completion in 2029-06. Interventions recorded: Paclitaxel; Carboplatin; Pembrolizumab; Doxorubicin; Cyclophosphamide; Olaparib; Capecitabine. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Stage II-III TNBC - estrogen receptor (ER) and progesterone receptor (PR) up to and including 10% is eligible\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06245889","url":"https://clinicaltrials.gov/study/NCT06245889"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","parp-inhibitor","platinum"],"targets":[],"drugs":["paclitaxel","carboplatin","pembrolizumab","doxorubicin","cyclophosphamide","olaparib","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06245889","phase":"2","setting":"A Pilot Study of Neoadjuvant Response-Adapted Chemotherapy With Pembrolizumab in Patients With Stage 2 and 3 Triple Negative Breast Cancer to Determine Early PET and Biomarker Dynamics","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","started":"2024-05-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06617481","kind":"trial","name":"PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence","aka":["RhPSMA-7"],"tldr":"A phase 2 trial of Flotufolastat F-18 in Prostate cancer, run by AdventHealth, now recruiting.","summary":"PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence is a phase 2 interventional study registered as NCT06617481 by AdventHealth, with 30 participants planned, started 2024-09-20 and due to reach its primary completion in 2027-09-05. Interventions recorded: 18F-rhPSMA-7.3 (Posluma). Conditions recorded: Prostate Cancer (Post Prostatectomy).\n\nLinked to the drug Flotufolastat F-18 because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06617481","url":"https://clinicaltrials.gov/study/NCT06617481"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-bcr"],"sections":[],"technologies":[],"targets":[],"drugs":["flotufolastat"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06617481","phase":"2","setting":"RhPSMA-7.3(18F)-PET Scan to Detect Prostate Cancer in Patients with Early PSA Recurrence","sponsor":"AdventHealth","started":"2024-09-20","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02814968","kind":"trial","name":"PET/CT and WB MRI for Staging and Response in CRPC Patients Receiving Enzalutamide","aka":[],"tldr":"A phase 2 trial of Whole-body MRI in Prostate cancer, run by The European Uro-Oncology Group, completed.","summary":"PET/CT and WB MRI for Staging and Response in CRPC Patients Receiving Enzalutamide is a phase 2 interventional study registered as NCT02814968 by The European Uro-Oncology Group, with 66 participants recorded, started 2015-02 and reaching its primary completion in 2020-06. Interventions recorded: Enzalutamide, 18-FDG PET/CT, Whole body MRI, Bone scan. Conditions recorded: Prostate Cancer Metastatic.\n\nLinked to the technology Whole-body MRI because the registry names it (\"whole body mri\") among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02814968","url":"https://clinicaltrials.gov/study/NCT02814968"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["whole-body-mri"],"targets":[],"drugs":["enzalutamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02814968","phase":"2","setting":"A Phase 2, Open-label, Single-arm, Efficacy and Imaging Study of Oral Enzalutamide in Chemo-Naïve Patients With Progressive Prostate Cancer Who Have Failed Androgen Deprivation Therapy (Castration-resistant Prostate Cancer Patients)","sponsor":"The European Uro-Oncology Group","started":"2015-02","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06057831","kind":"trial","name":"PET/MRI in Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by AHS Cancer Control Alberta, not yet recruiting.","summary":"PET/MRI in Rectal Cancer is a phase 2, interventional study registered as NCT06057831 by AHS Cancer Control Alberta, with a registry enrolment figure of 40 participants, started 2026-05 and due to reach its primary completion in 2029-05. Interventions recorded: Total Neo-adjuvant Therapy; 18FDG-PET/MRI scan. Conditions listed: Rectal Cancer. Primary outcome: The primary endpoint of the study is pathological response (pCR) prediction with PET/MRI.; Correlation between PET/MRI reported pCR and complete(pCR) or incomplete response(non-pCR) to total neoadjuvant therapy determined by final pathology will be defined.. Colorectal eligibility wording from the registry: \"Patients with histologically proven adenocarcinoma of the rectum\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06057831","url":"https://clinicaltrials.gov/study/NCT06057831"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06057831","phase":"2","setting":"18FDG-PET/MRI Imaging in Predicting Pathological Response to Total Neo-adjuvant Therapy in Rectal Cancer","sponsor":"AHS Cancer Control Alberta","started":"2026-05","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"petacc-3","kind":"trial","name":"PETACC-3","aka":[],"tldr":"Irinotecan works in advanced bowel cancer and does nothing after surgery. The trial's tumour bank turned out to be worth more than its result.","summary":"PETACC-3 tested whether irinotecan added to biweekly infusional fluorouracil and leucovorin improves adjuvant treatment of colon cancer. In the principal analysis of 2,094 treated stage III patients, five-year disease-free survival was 56.7 percent with irinotecan against 54.3 percent without (log-rank p=0.106) and five-year overall survival 73.6 against 71.3 percent (p=0.094); irinotecan increased grade 3 to 4 gastrointestinal events and neutropenia. With CALGB 89803 reaching the same conclusion, irinotecan was abandoned in the adjuvant setting, and the pattern, that a drug active in metastatic disease can add nothing to surgery, repeated itself later with cetuximab and with bevacizumab. The trial's large annotated tumour bank became one of the main sources for the prognostic work on microsatellite instability, BRAF and the gene-expression subtypes that became the consensus molecular subtypes.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00026273","url":"https://clinicaltrials.gov/study/NCT00026273"},{"label":"PETACC-3: irinotecan added to adjuvant fluorouracil and leucovorin in stage III colon cancer (Journal of Clinical Oncology 2009)","url":"https://doi.org/10.1200/JCO.2008.21.6663"}],"tags":[],"related":[],"cancers":["colorectal","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["irinotecan","fluorouracil","leucovorin"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","cms-subtypes","msi"],"trials":["n0147","mosaic"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00026273","phase":"3","setting":"Stage II and III colon cancer after resection: biweekly infusional fluorouracil and leucovorin with or without irinotecan","sponsor":"Pan-European Trials in Alimentary Tract Cancer / Pfizer","result":"Five-year disease-free survival 56.7 against 54.3 percent (p=0.106); no overall survival gain.","started":"2001-01","yearReported":2009,"enrolled":2094,"enrolledBasis":"analysed","enrolledNote":"3,278 patients were enrolled; the principal efficacy analysis was of the 2,094 treated patients with stage III disease randomised in the LV5FU2 strata.","outcomes":[{"endpoint":"Disease-free survival at 5 years (stage III)","primary":true,"unit":"percent","arms":[{"name":"Irinotecan with LV5FU2","value":56.7},{"name":"LV5FU2","value":54.3}],"p":"0.106","source":"https://doi.org/10.1200/JCO.2008.21.6663"}],"replication":"CALGB 89803 also found no benefit from adjuvant irinotecan."},{"id":"petacc-8","kind":"trial","name":"PETACC-8","aka":[],"tldr":"Adding the EGFR antibody cetuximab to chemotherapy after surgery did not help, even in patients whose tumours had no KRAS mutation.","summary":"PETACC-8 randomised 2,559 patients with resected stage III colon cancer in 340 European centres to FOLFOX4 with or without cetuximab. In the 1,602 patients with KRAS exon 2 wild-type tumours, disease-free survival was no different (hazard ratio 1.05, 95% CI 0.85 to 1.29, p=0.66), and there was no benefit in the KRAS exon 2 and BRAF wild-type subgroup either (0.99, 0.76 to 1.28). Grade 3 or 4 acne-like rash affected 27 percent of the cetuximab group. With N0147 reaching the same conclusion in North America, the two trials closed the question: anti-EGFR antibodies work in metastatic left-sided RAS wild-type disease and have no place in the adjuvant setting.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00265811","url":"https://clinicaltrials.gov/study/NCT00265811"},{"label":"PETACC-8: FOLFOX4 with or without cetuximab in resected stage III colon cancer (Lancet Oncology 2014)","url":"https://doi.org/10.1016/S1470-2045(14)70227-X"}],"tags":[],"related":[],"cancers":["colorectal","colon-cancer"],"sections":[],"technologies":["monoclonal-antibody","cytotoxic-chemotherapy"],"targets":["egfr","kras"],"drugs":["cetuximab","folfox","oxaliplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["n0147"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00265811","phase":"3","setting":"Resected stage III colon cancer: FOLFOX4 with or without cetuximab","sponsor":"Fédération Francophone de Cancérologie Digestive","result":"No disease-free survival benefit from cetuximab in KRAS wild-type disease (hazard ratio 1.05).","started":"2005-11","startedType":"actual","yearReported":2014,"enrolled":2559,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival (KRAS exon 2 wild-type)","primary":true,"unit":"hazard ratio","arms":[{"name":"FOLFOX4 plus cetuximab","n":791,"value":1.05},{"name":"FOLFOX4","n":811,"value":1}],"hr":1.05,"ci":[0.85,1.29],"p":"0.66","source":"https://doi.org/10.1016/S1470-2045(14)70227-X"}],"replication":"Same result as Alliance N0147 in North America."},{"id":"nct03268954","kind":"trial","name":"Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)","aka":[],"tldr":"A phase 3 trial of Azacitidine and Pevonedistat in Leukaemia, run by Takeda, completed.","summary":"Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) is a phase 3 interventional study registered as NCT03268954 by Takeda, with 454 participants recorded, started 2017-11-28 and reaching its primary completion in 2021-05-28. Interventions recorded: Azacitidine, Pevonedistat. Conditions recorded: Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute.\n\nLinked to the drug Pevonedistat because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03268954","url":"https://clinicaltrials.gov/study/NCT03268954"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["azacitidine","pevonedistat"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03268954","phase":"3","setting":"A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia","sponsor":"Takeda","started":"2017-11-28","startedType":"actual","yearReported":2022,"enrolled":454,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-Free Survival (EFS)","primary":true,"unit":"months","arms":[{"name":"Azacitidine 75 mg/m^2","n":227,"value":15.7,"note":"95% CI 14.42 to 19.68; Figures from the ClinicalTrials.gov results section (first posted 2022-09-22), not from a publication"},{"name":"Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2","n":227,"value":17.7,"note":"95% CI 13.63 to 20.24"}],"hr":0.968,"ci":[0.757,1.238],"p":"0.557","source":"https://clinicaltrials.gov/study/NCT03268954?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Azacitidine 75 mg/m^2","n":227,"value":16.8,"note":"95% CI 14.92 to 20.11; Figures from the ClinicalTrials.gov results section (first posted 2022-09-22), not from a publication"},{"name":"Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2","n":227,"value":20.3,"note":"95% CI 17.97 to 22.60"}],"hr":0.888,"ci":[0.709,1.113],"p":"0.152","source":"https://clinicaltrials.gov/study/NCT03268954?tab=results"}]},{"id":"nct04553133","kind":"trial","name":"PF-07104091 as a Single Agent and in Combination Therapy","aka":[],"tldr":"A phase 2 trial of Palbociclib, Fulvestrant, Letrozole in small-cell lung cancer and ovarian cancer, run by Pfizer, active and no longer recruiting.","summary":"PF-07104091 as a Single Agent and in Combination Therapy is a phase 2 interventional study registered as NCT04553133 by Pfizer, with 157 participants enrolled, started 2020-09-16 and due to reach its primary completion in 2026-12-31. Interventions recorded: PF-07104091 monotherapy dose escalation, PF-07104091 + palbociclib + fulvestrant, PF-07104091 + palbociclib + letrozole, PF-07104091 monotherapy dose expansion (ovarian), PF-07104091 monotherapy dose expansion (SCLC). Conditions listed: Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04553133","url":"https://clinicaltrials.gov/study/NCT04553133"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["palbociclib","fulvestrant","letrozole"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04553133","phase":"2","setting":"PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY","sponsor":"Pfizer","started":"2020-09-16","startedType":"actual","enrolled":157,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04910022","kind":"trial","name":"Ph I/II Study of NMS-03305293+TMZ in Adult Patients With Recurrent Glioblastoma","aka":[],"tldr":"A phase 1/2 trial of Temozolomide in glioma & glioblastoma, run by Nerviano Medical Sciences, active and no longer recruiting.","summary":"Ph I/II Study of NMS-03305293+TMZ in Adult Patients With Recurrent Glioblastoma is a phase 1/2 interventional study registered as NCT04910022 by Nerviano Medical Sciences, with 150 participants enrolled, started 2021-12-01 and due to reach its primary completion in 2027-05-30. Interventions recorded: NMS-03305293 and Temozolomide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04910022","url":"https://clinicaltrials.gov/study/NCT04910022"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":["nerviano-medical-sciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04910022","phase":"1/2","setting":"A Phase I/II Combination Study of NMS-03305293 and Temozolomide in Adult Patients With Recurrent Glioblastoma","sponsor":"Nerviano Medical Sciences","started":"2021-12-01","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03647163","kind":"trial","name":"Ph I/II Trial of Systemic VSV-IFNβ-NIS in Combination With Checkpoint Inhibitor Therapy in Patients With Select Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab, Ipilimumab, Nivolumab in non-small-cell lung cancer and small-cell lung cancer, run by Vyriad, Inc., active and no longer recruiting.","summary":"Ph I/II Trial of Systemic VSV-IFNβ-NIS in Combination With Checkpoint Inhibitor Therapy in Patients With Select Solid Tumors is a phase 1/2 interventional study registered as NCT03647163 by Vyriad, Inc., with 33 participants enrolled, started 2019-04-09 and due to reach its primary completion in 2025-07-31. Interventions recorded: VSV-IFNβ-NIS, Pembrolizumab, ipilimumab + nivolumab. Conditions listed: Solid Tumor, Non Small Cell Lung Cancer, Neuroendocrine Carcinoma, Renal Cell Carcinoma (RCC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03647163","url":"https://clinicaltrials.gov/study/NCT03647163"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","ipilimumab","nivolumab"],"companies":["vyriad"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03647163","phase":"1/2","setting":"Phase 1-2 Trial of Systemically Administered VSV-IFNβ-NIS in Combination With Checkpoint Inhibitor Therapy in Patients With Selected Solid Tumors","sponsor":"Vyriad, Inc.","started":"2019-04-09","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07795749","kind":"trial","name":"Ph II Intraperitoneal Paclitaxel + System Therapy in GI Ca w/Peritoneal Carcinomatosis (STOPGAP-B)","aka":["STOPGAP-B"],"tldr":"A phase 2 trial in colorectal cancer, run by University of California, Irvine, now recruiting.","summary":"Ph II Intraperitoneal Paclitaxel + System Therapy in GI Ca w/Peritoneal Carcinomatosis (STOPGAP-B) is a phase 2, interventional study registered as NCT07795749 by University of California, Irvine, with a registry enrolment figure of 55 participants, started 2026-08-04 and due to reach its primary completion in 2029-08-31. Interventions recorded: Paclitaxel Q2W; Paclitaxcel Q3W. Conditions listed: Esophageal Carcinoma; Gastric Cancer (Diagnosis); Colorectal Adenocarcinoma; Appendiceal Adenocarcinoma; Small Bowel Adenocarcinoma; Hepatobiliary Carcinoma in Situ. Primary outcome: Protocol Treatment Completion Rate. Colorectal eligibility wording from the registry: \"* Cohort B: Patients must have histologically or cytologically confirmed primary colorectal or appendiceal adenocarcinoma with PC\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07795749","url":"https://clinicaltrials.gov/study/NCT07795749"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07795749","phase":"2","setting":"Phase II Basket Trial of Intraperitoneal Paclitaxel Plus Systemic Therapy in Gastrointestinal Malignancies With Peritoneal Carcinomatosis (STOPGAP - B)","sponsor":"University of California, Irvine","started":"2026-08-04","startedType":"actual","enrolled":55,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06553885","kind":"trial","name":"Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC","aka":[],"tldr":"A phase 2 trial of enfortumab vedotin in colorectal cancer, run by H. Lee Moffitt Cancer Center and Research Institute, now recruiting.","summary":"Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC is a phase 2, interventional study registered as NCT06553885 by H. Lee Moffitt Cancer Center and Research Institute, with a registry enrolment figure of 40 participants, started 2025-04-01 and due to reach its primary completion in 2029-09. Interventions recorded: Enfortumab Vedotin. Conditions listed: Metastatic Colorectal Cancer; Hepatocellular Carcinoma. Primary outcome: Overall response rate (ORR). Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06553885","url":"https://clinicaltrials.gov/study/NCT06553885"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["enfortumab-vedotin"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06553885","phase":"2","setting":"A Phase II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic Colorectal Cancer or Hepatocellular Carcinoma","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","started":"2025-04-01","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05671822","kind":"trial","name":"Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer","aka":[],"tldr":"A phase 2 trial of Trastuzumab rezetecan, Retlirafusp alfa, Capecitabine, Adebrelimab and Oxaliplatin in gastric & gastro-oesophageal junction cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer is a phase 2 interventional study registered as NCT05671822 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 258 participants planned, started 2023-03-14 and due to reach its primary completion in 2027-12. Interventions recorded: SHR-A1811 and SHR-1701, SHR-A1811 and capecitabine, SHR-A181, SHR-1701, and capecitabine, SHR-A1811, SHR-1316, and capecitabine, SHR-A1811, SHR-1316, capecitabine,and oxaliplatin and SHR-A1811, SHR-1316, and 5-FU.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05671822","url":"https://clinicaltrials.gov/study/NCT05671822"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","retlirafusp-alfa","capecitabine","adebrelimab","oxaliplatin"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05671822","phase":"2","setting":"A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2023-03-14","startedType":"actual","enrolled":258,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04379596","kind":"trial","name":"Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)","aka":["DESTINY-Gastric03"],"tldr":"A phase 2 trial of Fluorouracil (5-FU), Capecitabine, Durvalumab, Oxaliplatin, Trastuzumab and Trastuzumab deruxtecan in gastric & gastro-oesophageal junction cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) is a phase 2 interventional study registered as NCT04379596 by AstraZeneca, with 452 participants enrolled, started 2020-06-03 and due to reach its primary completion in 2027-05-04. Interventions recorded: Fluorouracil (5-FU), Capecitabine, Durvalumab, Oxaliplatin, Trastuzumab and Trastuzumab deruxtecan.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04379596","url":"https://clinicaltrials.gov/study/NCT04379596"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":["adc","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["fluorouracil","capecitabine","durvalumab","oxaliplatin","trastuzumab","trastuzumab-deruxtecan"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04379596","phase":"2","setting":"A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)","sponsor":"AstraZeneca","started":"2020-06-03","startedType":"actual","enrolled":452,"enrolledBasis":"registry","outcomes":[]},{"id":"phallcon","kind":"trial","name":"PhALLCON","aka":[],"tldr":"Head to head, the third-generation TKI ponatinib doubled the rate of deep, undetectable remission over imatinib in newly diagnosed Ph-positive ALL.","summary":"PhALLCON, trial NCT03589326 sponsored by Takeda and published in JAMA in 2024, was the first randomised comparison of tyrosine kinase inhibitors in newly diagnosed Philadelphia-positive acute lymphoblastic leukaemia, and it showed that ponatinib doubles the rate of deep, MRD-negative remission over imatinib when each is given with reduced-intensity chemotherapy. It randomised 245 adults and met its primary endpoint of MRD-negative complete remission at the end of induction, with fewer treatment failures and comparable arterial occlusive events at the reduced dosing, leading to accelerated approval in March 2024. OnCo links it to acute lymphoblastic leukaemia, BCR::ABL1 as a target, ponatinib, imatinib, the Ph-positive ALL term and the pairing of a BCR::ABL1 inhibitor with blinatumomab. Whether chemotherapy can be dropped entirely with ponatinib plus blinatumomab is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03589326","url":"https://clinicaltrials.gov/study/NCT03589326"}],"tags":[],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["bcr-abl"],"drugs":["ponatinib","imatinib"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":["ph-positive-all","mrd-negative-cr"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03589326","phase":"3","setting":"Newly diagnosed Ph-positive ALL, adults: ponatinib vs imatinib, each with reduced-intensity chemotherapy","sponsor":"Takeda","result":"MRD-negative CR 34.4% vs 16.7%.","started":"2018-10-04","startedType":"actual","yearReported":2024,"enrolled":245,"enrolledBasis":"registry","outcomes":[{"endpoint":"MRD-negative complete remission at end of induction","primary":true,"unit":"%","arms":[{"name":"Ponatinib + chemotherapy","n":164,"value":34.4},{"name":"Imatinib + chemotherapy","n":81,"value":16.7}],"p":"0.002","source":"https://jamanetwork.com/journals/jama/fullarticle/2819187"}],"replication":"Single-arm hyper-CVAD + ponatinib series (MD Anderson) report 5-year OS ~75%; GIMEMA and GRAAPH studies with dasatinib/nilotinib show lower molecular response rates, consistent with a class-potency effect."},{"id":"nct01064466","kind":"trial","name":"Pharmacogenomics ANDA SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms","aka":["Drugs-SNPs"],"tldr":"A phase 2/3 trial of Etoposide in small-cell lung cancer, run by Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair, active and no longer recruiting.","summary":"Pharmacogenomics ANDA SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms is a phase 2/3 interventional study registered as NCT01064466 by Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair, with 600 participants enrolled, started 2025-07-16 and due to reach its primary completion in 2026-11-18. Interventions recorded: ETOPOSIDE - Usual and ETOPOSIDE - Study.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01064466","url":"https://clinicaltrials.gov/study/NCT01064466"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["etoposide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01064466","phase":"2/3","setting":"Explore the Relationship Between Single Nucleotide Polymorphisms and Etoposide Response and Toxicity in Patients With Small Cell Lung Cancer.","sponsor":"Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair","started":"2025-07-16","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07145333","kind":"trial","name":"Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms","aka":["Drug-SNP"],"tldr":"A phase 2/3 trial of Topotecan in small-cell lung cancer, run by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, active and no longer recruiting.","summary":"Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms is a phase 2/3 interventional study registered as NCT07145333 by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, with 600 participants enrolled, started 2025-08-12 and due to reach its primary completion in 2026-09-18. Interventions recorded: Topotecan - usual and Topotecan - study.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07145333","url":"https://clinicaltrials.gov/study/NCT07145333"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["topotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07145333","phase":"2/3","setting":"Explore the Relationship Between Single Nucleotide Polymorphisms and Topotecan Response and Toxicity in Patients With Small Cell Lung Cancer.","sponsor":"Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair","started":"2025-08-12","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03348670","kind":"trial","name":"Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms","aka":["Drugs-SNPs"],"tldr":"A phase 2/3 trial of Abiraterone - Usual in prostate cancer, run by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, active and no longer recruiting.","summary":"Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms is a phase 2/3 interventional study registered as NCT03348670 by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, with 600 participants enrolled, started 2023-08-18 and due to reach its primary completion in 2026-11-18. Interventions recorded: Abiraterone - Usual and Abiraterone - Study.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03348670","url":"https://clinicaltrials.gov/study/NCT03348670"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["abiraterone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03348670","phase":"2/3","setting":"Explore the Relationship Between Single Nucleotide Polymorphisms and Abiraterone Response and Toxicity in Patients With Prostate Cancer.","sponsor":"Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair","started":"2023-08-18","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05987956","kind":"trial","name":"Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms","aka":["Drugs-SNPs"],"tldr":"A phase 2/3 trial of Alectinib in non-small-cell lung cancer, run by Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair, active and no longer recruiting.","summary":"Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms is a phase 2/3 interventional study registered as NCT05987956 by Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair, with 600 participants enrolled, started 2026-03-18 and due to reach its primary completion in 2026-11-18. Interventions recorded: ALECENSA - alectinib hydrochloride capsule.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05987956","url":"https://clinicaltrials.gov/study/NCT05987956"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["alectinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05987956","phase":"2/3","setting":"Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer.","sponsor":"Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair","started":"2026-03-18","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06430866","kind":"trial","name":"Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)","aka":["Eucalyptus"],"tldr":"A phase 3 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Amgen, active and no longer recruiting.","summary":"Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab) is a phase 3 interventional study registered as NCT06430866 by Amgen, with 163 participants enrolled, started 2024-09-12 and due to reach its primary completion in 2026-12-14. Interventions recorded: ABP 234, Pembrolizumab. Conditions listed: Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06430866","url":"https://clinicaltrials.gov/study/NCT06430866"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06430866","phase":"3","setting":"A Randomized, Double-blind Study to Compare the Pharmacokinetics Between ABP 234 and Keytruda® (Pembrolizumab) in Participants With Early-stage Non-squamous Non-small Cell Lung Cancer as Adjuvant Treatment Following Resection and Platinum-based Chemotherapy","sponsor":"Amgen","started":"2024-09-12","startedType":"actual","enrolled":163,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07162883","kind":"trial","name":"Pharmacokinetic Study of QL2107 Versus Keytruda® for Adjuvant Therapy of Non-Small Cell Lung Cancer (NSCLC)","aka":[],"tldr":"A phase 3 trial of QL2107 and pembrolizumab in lung cancer, run by Qilu Pharmaceutical Co., Ltd., not yet recruiting.","summary":"Pharmacokinetic Study of QL2107 Versus Keytruda® for Adjuvant Therapy of Non-Small Cell Lung Cancer (NSCLC) is a phase 3, randomised interventional study registered as NCT07162883 by Qilu Pharmaceutical Co., Ltd., with a registry enrolment figure of 122 participants, started 2025-09-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: QL2107; Keytruda®. Conditions listed: Carcinoma, Non-Small-Cell Lung. Primary outcome: AUCtau,sd of QL2107 and Keytruda; AUCtau,ss of QL2107 and Keytruda. Lung eligibility wording from the registry: \"* Disease status: Participants with completely resected, histologically- or cytologically-confirmed (Stage II or IIIA) NSCLC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07162883","url":"https://clinicaltrials.gov/study/NCT07162883"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ql2107","pembrolizumab"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07162883","phase":"3","setting":"A Randomized, Double-Blind, Multicenter, Pharmacokinetic Equivalence Clinical Trial of QL2107 (Keytruda® Biosimilar Candidate) in Comparison With Keytruda® (Pembrolizumab) for Adjuvant Therapy to Demonstrate Pharmacokinetic Similarity in Subjects With Resected Non-Small Cell Lung Cancer","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2025-09-01","startedType":"estimated","enrolled":122,"enrolledBasis":"registry","outcomes":[]},{"id":"pharos","kind":"trial","name":"PHAROS","aka":[],"tldr":"PHAROS showed that the melanoma combination encorafenib and binimetinib shrinks three quarters of untreated BRAF V600E lung cancers and nearly half of previously treated ones, giving a second approved BRAF plus MEK pair for lung cancer.","summary":"PHAROS treated 98 patients with metastatic BRAF V600E-mutant non-small-cell lung cancer with encorafenib 450 mg daily and binimetinib 45 mg twice daily, 59 of them treatment-naive and 39 previously treated. Dabrafenib plus trametinib had been approved for this population in 2017 on a similar single-arm design.\n\nThe response rate was 75 percent in treatment-naive patients and 46 percent in previously treated patients, with median durations of response of about 40 months and 16.7 months respectively. Nausea, diarrhoea, fatigue and vomiting were the main side effects; the fever that limits dabrafenib and trametinib was uncommon.\n\nThe FDA approved encorafenib with binimetinib for BRAF V600E lung cancer in October 2023. Non-V600 BRAF mutations, about half of BRAF-mutant lung cancers, do not respond to these drugs.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03915951","url":"https://clinicaltrials.gov/study/NCT03915951"},{"label":"Journal of Clinical Oncology 2023","url":"https://doi.org/10.1200/JCO.23.00774"}],"tags":[],"related":[],"cancers":["nsclc","braf-v600e-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["braf"],"drugs":["encorafenib","binimetinib","dabrafenib-trametinib"],"companies":["pfizer"],"institutions":[],"pathways":["ras-mapk"],"terms":["braf-v600-mutation"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-pharos-j-thorac-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03915951","phase":"2","setting":"Metastatic BRAF V600E-mutant non-small-cell lung cancer, treatment-naive or previously treated: encorafenib plus binimetinib","sponsor":"Pfizer","result":"Response rate 75% (treatment-naive, n=59) and 46% (previously treated, n=39); FDA approval October 2023.","started":"2019-06-04","startedType":"actual","yearReported":2023,"enrolled":98,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (independent review)","primary":true,"unit":"%","arms":[{"name":"Treatment-naive","n":59,"value":75},{"name":"Previously treated","n":39,"value":46}],"source":"https://doi.org/10.1200/JCO.23.00774"}],"replication":"Consistent with the BRF113928 study of dabrafenib plus trametinib (response rate 64 percent treatment-naive, 63 percent previously treated)."},{"id":"nct02503423","kind":"trial","name":"Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas","aka":[],"tldr":"A phase 1/2 trial of ASTX660 in non-Hodgkin lymphoma, run by Taiho Oncology, Inc., active and no longer recruiting.","summary":"Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas is a phase 1/2 interventional study registered as NCT02503423 by Taiho Oncology, Inc., with 253 participants enrolled, started 2015-07-14 and due to reach its primary completion in 2022-10. Interventions recorded: ASTX660.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02503423","url":"https://clinicaltrials.gov/study/NCT02503423"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["araris"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02503423","phase":"1/2","setting":"Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas","sponsor":"Taiho Oncology, Inc.","started":"2015-07-14","startedType":"actual","enrolled":253,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07612280","kind":"trial","name":"Phase 1/ Phase 2 Study to Assess Safety and Efficacy of Orally Administered JBI-802 in Subjects With Myeloproliferative Neoplasms (MPN) and Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) With Thrombocytosis","aka":[],"tldr":"A phase 1/2 trial of JBI-802 in myeloproliferative neoplasms and chronic myelomonocytic leukaemia and MDS/MPN overlap neoplasms, run by Jubilant Therapeutics Inc., now recruiting.","summary":"Phase 1/ Phase 2 Study to Assess Safety and Efficacy of Orally Administered JBI-802 in Subjects With Myeloproliferative Neoplasms (MPN) and Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) With Thrombocytosis is a phase 1/2 interventional study registered as NCT07612280 by Jubilant Therapeutics Inc., with 30 participants planned, started 2024-10-21 and due to reach its primary completion in 2028-06-15. Interventions recorded: JBI-802.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07612280","url":"https://clinicaltrials.gov/study/NCT07612280"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","cmml"],"sections":[],"technologies":[],"targets":[],"drugs":["jbi-802"],"companies":["jubilant-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07612280","phase":"1/2","setting":"Study to Assess Safety and Preliminary Efficacy of Orally Administered JBI-802 in Subjects With Myeloproliferative Neoplasms (MPN) and Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) With Thrombocytosis","sponsor":"Jubilant Therapeutics Inc.","started":"2024-10-21","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04115306","kind":"trial","name":"Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer","aka":["Dauntless-1"],"tldr":"A phase 1/2 trial of Fulvestrant in advanced solid tumours, run by Phoenix Molecular Designs, active and no longer recruiting.","summary":"Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer is a phase 1/2 interventional study registered as NCT04115306 by Phoenix Molecular Designs, with 61 participants enrolled, started 2019-11-14 and due to reach its primary completion in 2026-12. Interventions recorded: PMD-026 and fulvestrant.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04115306","url":"https://clinicaltrials.gov/study/NCT04115306"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["fulvestrant"],"companies":["molecular-partners"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04115306","phase":"1/2","setting":"Ph 1/1b/2 Multicenter, Open-Label, FIH Dose Esc & Dose Exp Study to Assess Safety and Tolerability of Orally Administered PMD-026 as a Single Agent and in Combination in Patients With Metastatic or Locally Advanced (Inoperable) RSK2+ Breast Cancer","sponsor":"Phoenix Molecular Designs","started":"2019-11-14","startedType":"actual","enrolled":61,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06639256","kind":"trial","name":"Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Test Product HY07121 in advanced solid tumours, run by Sichuan Huiyu Pharmaceutical Co., Ltd, now recruiting.","summary":"Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06639256 by Sichuan Huiyu Pharmaceutical Co., Ltd, with 258 participants planned, started 2024-10-24 and due to reach its primary completion in 2026-05. Interventions recorded: Test Product HY07121.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06639256","url":"https://clinicaltrials.gov/study/NCT06639256"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sichuan-huiyu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06639256","phase":"1/2","setting":"An Open-label, Multiple-center, Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors","sponsor":"Sichuan Huiyu Pharmaceutical Co., Ltd","started":"2024-10-24","startedType":"actual","enrolled":258,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06139575","kind":"trial","name":"Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer","aka":[],"tldr":"A phase 1/2 trial of Lutetium Lu 177 JH020002 Injection in prostate cancer, run by Bivision Pharmaceuticals, Inc., now recruiting.","summary":"Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer is a phase 1/2 interventional study registered as NCT06139575 by Bivision Pharmaceuticals, Inc., with 90 participants planned, started 2023-12-22 and due to reach its primary completion in 2026-05. Interventions recorded: Lutetium Lu 177 JH020002 Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06139575","url":"https://clinicaltrials.gov/study/NCT06139575"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06139575","phase":"1/2","setting":"Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Preliminary Efficacy of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer","sponsor":"Bivision Pharmaceuticals, Inc.","started":"2023-12-22","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07145255","kind":"trial","name":"Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ADC in prostate cancer, colorectal cancer and pancreatic ductal adenocarcinoma, run by MBrace Therapeutics, now recruiting.","summary":"Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors is a phase 1/2 interventional study registered as NCT07145255 by MBrace Therapeutics, with 150 participants planned, started 2025-09-03 and due to reach its primary completion in 2029-09-30. Interventions recorded: ADC.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07145255","url":"https://clinicaltrials.gov/study/NCT07145255"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","colorectal","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["mbrace-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07145255","phase":"1/2","setting":"A Multicenter, Open-label Phase 1/2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-201, an Antibody-drug Conjugate, in Advanced Refractory Solid Tumors","sponsor":"MBrace Therapeutics","started":"2025-09-03","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04868877","kind":"trial","name":"Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and in Combina","aka":[],"tldr":"A phase 1/2 trial of MCLA-129, Osimertinib in non-small-cell lung cancer and small-cell lung cancer, run by Merus B.V., active and no longer recruiting.","summary":"Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and in Combination is a phase 1/2 interventional study registered as NCT04868877 by Merus B.V., with 194 participants enrolled, started 2021-04-28 and due to reach its primary completion in 2026-03. Interventions recorded: MCLA-129, Osimertinib, Chemotherapy. Conditions listed: Non-Small Cell Lung Cancer Metastatic, Gastric Cancer, Esophageal Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04868877","url":"https://clinicaltrials.gov/study/NCT04868877"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","head-and-neck","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["mcla-129","osimertinib"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04868877","phase":"1/2","setting":"Phase 1/2 Dose Escalation and Expansion Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors","sponsor":"Merus B.V.","started":"2021-04-28","startedType":"actual","enrolled":194,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05074810","kind":"trial","name":"Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients","aka":["RAMP203"],"tldr":"A phase 1/2 trial of Sotorasib in non-small-cell lung cancer and small-cell lung cancer, run by Verastem, Inc., active and no longer recruiting.","summary":"Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients is a phase 1/2 interventional study registered as NCT05074810 by Verastem, Inc., with 153 participants planned, started 2022-04-12 and due to reach its primary completion in 2026-06. Interventions recorded: avutometinib and sotorasib, avutometinib and sotorasib and defactinib. Conditions listed: Non Small Cell Lung Cancer, KRAS Activating Mutation. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05074810","url":"https://clinicaltrials.gov/study/NCT05074810"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","kras-g12c-nsclc"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["sotorasib"],"companies":["verastem"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05074810","phase":"1/2","setting":"A Phase 1/2 Study of Avutometinib (VS-6766) in Combination With Sotorasib With or Without Defactinib in Patients With KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Verastem, Inc.","started":"2022-04-12","startedType":"actual","enrolled":153,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07529808","kind":"trial","name":"Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma","aka":[],"tldr":"A phase 1/2 trial of BHB810 in gastric & gastro-oesophageal junction cancer, oesophageal cancer, colorectal cancer and pancreatic ductal adenocarcinoma, run by BigHat Biosciences, Inc., now recruiting.","summary":"Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma is a phase 1/2 interventional study registered as NCT07529808 by BigHat Biosciences, Inc., with 164 participants planned, started 2026-07 and due to reach its primary completion in 2028-12. Interventions recorded: BHB810.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07529808","url":"https://clinicaltrials.gov/study/NCT07529808"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","esophageal","colorectal","pancreatic","oesophageal-adenocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bighat-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07529808","phase":"1/2","setting":"Phase 1/2, Open-Label, Multicenter, Dose Escalation and Expansion Study of BHB810 in Participants With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma","sponsor":"BigHat Biosciences, Inc.","started":"2026-07","startedType":"estimated","enrolled":164,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05326243","kind":"trial","name":"Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma","aka":[],"tldr":"A phase 1/2 trial of CD19-targeted chimeric antigen receptor T-cell in diffuse large B-cell lymphoma and follicular lymphoma, run by Pell Bio-Med Technology Co., Ltd., now recruiting.","summary":"Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma is a phase 1/2 interventional study registered as NCT05326243 by Pell Bio-Med Technology Co., Ltd., with 49 participants planned, started 2022-05-31 and due to reach its primary completion in 2026-12-31. Interventions recorded: CD19-targeted chimeric antigen receptor T-cell.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05326243","url":"https://clinicaltrials.gov/study/NCT05326243"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["dlbcl","follicular-lymphoma"],"sections":[],"technologies":[],"targets":["cd19"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05326243","phase":"1/2","setting":"A Phase 1/2 Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of CD19-targeted Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) Therapy in Patients With Relapsed or Refractory B-cell Lymphoma","sponsor":"Pell Bio-Med Technology Co., Ltd.","started":"2022-05-31","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07589530","kind":"trial","name":"Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of EB-NK-301 and Fludarabine in advanced solid tumours, run by Beijing Biotech, now recruiting.","summary":"Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors is a phase 1/2 interventional study registered as NCT07589530 by Beijing Biotech, with 60 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-02-14. Interventions recorded: EB-NK-301 and Fludarabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07589530","url":"https://clinicaltrials.gov/study/NCT07589530"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["car-nk-macrophage"],"targets":[],"drugs":["eb-nk-301","fludarabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07589530","phase":"1/2","setting":"A Phase 1/2, Open-Label, Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of EB-NK-301 (Allogeneic TROP2-Targeted CAR NK Cells) Following Lymphodepleting Chemotherapy in Adults With Advanced or Metastatic TROP2-Expressing Solid Tumors","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06993844","kind":"trial","name":"Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Fulvestrant in advanced solid tumours, run by Ensem Therapeutics, now recruiting.","summary":"Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06993844 by Ensem Therapeutics, with 233 participants planned, started 2025-06-10 and due to reach its primary completion in 2027-06-30. Interventions recorded: ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant and ETX-636 dose expansion in combination with fulvestrant.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06993844","url":"https://clinicaltrials.gov/study/NCT06993844"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["fulvestrant"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06993844","phase":"1/2","setting":"A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors","sponsor":"Ensem Therapeutics","started":"2025-06-10","startedType":"actual","enrolled":233,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05367778","kind":"trial","name":"Phase 1/2 Study of HS-10370 in Patients with Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of HS-10370 in advanced solid tumours, run by Jiangsu Hansoh Pharmaceutical Co., Ltd., now recruiting.","summary":"Phase 1/2 Study of HS-10370 in Patients with Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05367778 by Jiangsu Hansoh Pharmaceutical Co., Ltd., with 176 participants planned, started 2022-06-03 and due to reach its primary completion in 2025-04-30. Interventions recorded: HS-10370.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05367778","url":"https://clinicaltrials.gov/study/NCT05367778"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05367778","phase":"1/2","setting":"A Phase 1/2, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10370 Monotherapy in Patients with Advanced Solid Tumors","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","started":"2022-06-03","startedType":"actual","enrolled":176,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05435248","kind":"trial","name":"Phase 1/2 Study of HS-10375 in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)","aka":[],"tldr":"A phase 1/2 trial of HS-10375 in non-small-cell lung cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd., now recruiting.","summary":"Phase 1/2 Study of HS-10375 in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC) is a phase 1/2 interventional study registered as NCT05435248 by Jiangsu Hansoh Pharmaceutical Co., Ltd., with 354 participants planned, started 2022-03-02 and due to reach its primary completion in 2025-03-31. Interventions recorded: HS-10375.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05435248","url":"https://clinicaltrials.gov/study/NCT05435248"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05435248-j-transl-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05435248","phase":"1/2","setting":"A Phase 1/2, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10375 Monotherapy in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","started":"2022-03-02","startedType":"actual","enrolled":354,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06243354","kind":"trial","name":"Phase 1/2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation","aka":[],"tldr":"A phase 1/2 trial of Test product: HYP-2090PTSA in advanced solid tumours, run by Sichuan Huiyu Pharmaceutical Co., Ltd, now recruiting.","summary":"Phase 1/2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation is a phase 1/2 interventional study registered as NCT06243354 by Sichuan Huiyu Pharmaceutical Co., Ltd, with 257 participants planned, started 2024-02-04 and due to reach its primary completion in 2026-12. Interventions recorded: Test product: HYP-2090PTSA.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06243354","url":"https://clinicaltrials.gov/study/NCT06243354"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["kras"],"drugs":[],"companies":["sichuan-huiyu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06243354","phase":"1/2","setting":"An Open-label, Multi-center, Multi-cohort, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HYP-2090PTSA in Patients With Advanced Solidt Tumors Harboring KRAS Mutation","sponsor":"Sichuan Huiyu Pharmaceutical Co., Ltd","started":"2024-02-04","startedType":"actual","enrolled":257,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06840119","kind":"trial","name":"Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers","aka":[],"tldr":"A phase 1/2 trial of IMC-R117C in advanced solid tumours, run by Immunocore Ltd, now recruiting.","summary":"Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers is a phase 1/2 interventional study registered as NCT06840119 by Immunocore Ltd, with 600 participants planned, started 2024-01-10 and due to reach its primary completion in 2026-11-30. Interventions recorded: IMC-R117C, Chemotherapy drug, Kinase inhibitor, Antiangiogenic Agent and Monoclonal antibody.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06840119","url":"https://clinicaltrials.gov/study/NCT06840119"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["immunocore"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06840119","phase":"1/2","setting":"A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a Single Agent and in Combination in HLA-A*02:01-Positive Participants With Selected Advanced PIWIL1-Positive Cancers","sponsor":"Immunocore Ltd","started":"2024-01-10","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06249048","kind":"trial","name":"Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by Strand Therapeutics Inc., now recruiting.","summary":"Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab is a phase 1/2 interventional study registered as NCT06249048 by Strand Therapeutics Inc., with 108 participants planned, started 2024-05-03 and due to reach its primary completion in 2027-05. Interventions recorded: STX-001 and Keytruda®.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06249048","url":"https://clinicaltrials.gov/study/NCT06249048"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["strand-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06249048","phase":"1/2","setting":"A Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients With Advanced Solid Tumors as a Monotherapy or in Combination With Pembrolizumab","sponsor":"Strand Therapeutics Inc.","started":"2024-05-03","startedType":"actual","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07751042","kind":"trial","name":"Phase 1/2 Study of Intravenous Injection of STX-003 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by Strand Therapeutics Inc., now recruiting.","summary":"Phase 1/2 Study of Intravenous Injection of STX-003 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab is a phase 1/2 interventional study registered as NCT07751042 by Strand Therapeutics Inc., with 220 participants planned, started 2026-06-30 and due to reach its primary completion in 2030-07-17. Interventions recorded: STX-003 and KEYTRUDA®.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07751042","url":"https://clinicaltrials.gov/study/NCT07751042"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["strand-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07751042","phase":"1/2","setting":"A Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Antitumor Activity of STX-003 Delivered Intravenously in Patients With Advanced Solid Tumors as a Monotherapy or in Combination With Pembrolizumab","sponsor":"Strand Therapeutics Inc.","started":"2026-06-30","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03785249","kind":"trial","name":"Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1","aka":["KRYSTAL-1"],"tldr":"A phase 1/2 trial of Pembrolizumab, Cetuximab, Afatinib in metastatic cancer, run by Mirati Therapeutics Inc., active and no longer recruiting.","summary":"Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1 is a phase 1/2 interventional study registered as NCT03785249 by Mirati Therapeutics Inc., with 731 participants enrolled, started 2019-01-15 and due to reach its primary completion in 2026-06-23. Interventions recorded: MRTX849, Pembrolizumab, Cetuximab, Afatinib. Conditions listed: Advanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03785249","url":"https://clinicaltrials.gov/study/NCT03785249"},{"label":"Bekaii-Saab et al., adagrasib in advanced solid tumours harbouring a KRAS G12C mutation (JCO 2023)","url":"https://doi.org/10.1200/JCO.23.00434"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","colorectal","kras-g12c-colorectal","kras-g12c-pdac","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","cetuximab","afatinib"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["kras-mutation-subtypes"],"trials":["codebreak-100"],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03785249-n-engl-j-med-2022"],"journals":[],"dependsOn":[],"notes":["KRYSTAL-1 phase 2 cohort of KRAS G12C solid tumours other than lung and colorectal cancer (JCO 2023, data cut 1 October 2022): 64 enrolled, 63 treated, median two prior lines; responses in 20 of 57 evaluable patients (35.1 percent), including 7 of 21 pancreatic (33.3 percent) and 5 of 12 biliary tract cancers; median duration of response 5.3 months, progression-free survival 7.4 months; treatment-related adverse events grade 3 to 4 in 27 percent, no discontinuations. This cohort is the NCCN basis for adagrasib in KRAS G12C pancreatic cancer; no regulator has approved the indication."],"nct":"NCT03785249","phase":"1/2","setting":"A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1","sponsor":"Mirati Therapeutics Inc.","result":"Pancreatic cancer cohort: objective response in 7 of 21 patients (33.3 percent); across the 57 evaluable non-lung, non-colorectal KRAS G12C tumours response 35.1 percent, median duration of response 5.3 months, median progression-free survival 7.4 months.","started":"2019-01-15","startedType":"actual","yearReported":2023,"enrolled":731,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response, pancreatic cancer cohort","unit":"%","arms":[{"name":"Adagrasib 600 mg twice daily","n":21,"value":33.3,"note":"7 of 21; all partial responses"}],"source":"https://doi.org/10.1200/JCO.23.00434"}]},{"id":"nct06795412","kind":"trial","name":"Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by Pyxis Oncology, Inc, now recruiting.","summary":"Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06795412 by Pyxis Oncology, Inc, with 220 participants planned, started 2025-04-15 and due to reach its primary completion in 2027-12-06. Interventions recorded: PYX-201 and pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06795412","url":"https://clinicaltrials.gov/study/NCT06795412"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06795412","phase":"1/2","setting":"A Phase 1/2, Open-label, Global, Multicenter, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","sponsor":"Pyxis Oncology, Inc","started":"2025-04-15","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05256290","kind":"trial","name":"Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations","aka":[],"tldr":"A phase 1/2 trial of Silevertinib in non-small-cell lung cancer and small-cell lung cancer, run by Black Diamond Therapeutics, Inc., active and no longer recruiting.","summary":"Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations is a phase 1/2 interventional study registered as NCT05256290 by Black Diamond Therapeutics, Inc., with 200 participants planned, started 2022-03-31 and due to reach its primary completion in 2025-11-03. Interventions recorded: silevertinib (BDTX-1535) monotherapy. Conditions listed: Non-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous Lung Cancer, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05256290","url":"https://clinicaltrials.gov/study/NCT05256290"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["silevertinib"],"companies":["black-diamond-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05256290","phase":"1/2","setting":"A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer","sponsor":"Black Diamond Therapeutics, Inc.","started":"2022-03-31","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05204862","kind":"trial","name":"Phase 1/2 Study of TU2218 Alone and in Combination With Checkpoint Inhibitors in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of TU2218 in advanced solid tumours, run by TiumBio Co., Ltd., now recruiting.","summary":"Phase 1/2 Study of TU2218 Alone and in Combination With Checkpoint Inhibitors in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05204862 by TiumBio Co., Ltd., with 240 participants planned, started 2021-12-02 and due to reach its primary completion in 2026-06-30. Interventions recorded: TU2218 and Anti-PD-1 antibody.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05204862","url":"https://clinicaltrials.gov/study/NCT05204862"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["tiumbio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05204862","phase":"1/2","setting":"A Phase 1/2 Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TU2218, an Oral TGFβR Inhibitor, Administered Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors","sponsor":"TiumBio Co., Ltd.","started":"2021-12-02","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04150497","kind":"trial","name":"Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)","aka":["BALLI-01"],"tldr":"A phase 1/2 trial of UCART22 in acute lymphoblastic leukaemia, run by Cellectis S.A., now recruiting.","summary":"Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01) is a phase 1/2 interventional study registered as NCT04150497 by Cellectis S.A., with 52 participants planned, started 2019-10-14 and due to reach its primary completion in 2026-06-30. Interventions recorded: UCART22 and CLLS52.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04150497","url":"https://clinicaltrials.gov/study/NCT04150497"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":[],"targets":[],"drugs":["ucart22"],"companies":["cellectis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04150497","phase":"1/2","setting":"Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)","sponsor":"Cellectis S.A.","started":"2019-10-14","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07605962","kind":"trial","name":"Phase 1/2 Study of UI-102 in Selected Advanced Cancers","aka":[],"tldr":"A phase 1/2 trial of UI-102 in advanced solid tumours, run by United Immunity, co., Ltd., now recruiting.","summary":"Phase 1/2 Study of UI-102 in Selected Advanced Cancers is a phase 1/2 interventional study registered as NCT07605962 by United Immunity, co., Ltd., with 140 participants planned, started 2026-05-20 and due to reach its primary completion in 2030-03-31. Interventions recorded: UI-102.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07605962","url":"https://clinicaltrials.gov/study/NCT07605962"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["tlr7"],"drugs":[],"companies":["united-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07605962","phase":"1/2","setting":"A Phase I/II Open-Label, Dose Escalation, Dose Optimization, and Cohort Expansion Trial to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of UI-102, a Novel Cholesteryl Pullulan (CHP) Nanoparticle-formulated TLR7/8 Agonist in Patients With Selected Locally Advanced and/or Metastatic Solid Tumors","sponsor":"United Immunity, co., Ltd.","started":"2026-05-20","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05573126","kind":"trial","name":"Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of EP0062, Elacestrant, Everolimus, Abemaciclib, Fulvestrant and Exemestane in HR-positive / HER2-negative breast cancer, run by Ellipses Pharma, now recruiting.","summary":"Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer is a phase 1/2 interventional study registered as NCT05573126 by Ellipses Pharma, with 95 participants planned, started 2023-01-11 and due to reach its primary completion in 2028-02. Interventions recorded: EP0062, Elacestrant, Everolimus, Abemaciclib, Fulvestrant and Exemestane.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05573126","url":"https://clinicaltrials.gov/study/NCT05573126"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["ep0062","elacestrant","everolimus","abemaciclib","fulvestrant","exemestane"],"companies":["ellipses-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05573126","phase":"1/2","setting":"A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 as Monotherapy and in Combination in Patients With Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer","sponsor":"Ellipses Pharma","started":"2023-01-11","startedType":"actual","enrolled":95,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07151040","kind":"trial","name":"Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors","aka":["ODIN"],"tldr":"A phase 1/2 trial of TH9619 in colorectal cancer, head and neck squamous cell carcinoma, non-small-cell lung cancer and gastric & gastro-oesophageal junction cancer, run by One-carbon Therapeutics AB, now recruiting.","summary":"Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07151040 by One-carbon Therapeutics AB, with 43 participants planned, started 2025-08-22 and due to reach its primary completion in 2026-12. Interventions recorded: TH9619.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07151040","url":"https://clinicaltrials.gov/study/NCT07151040"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","head-and-neck","nsclc","gastric"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07151040","phase":"1/2","setting":"A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation, Confirmation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of TH9619 in Subjects With Advanced Solid Tumors","sponsor":"One-carbon Therapeutics AB","started":"2025-08-22","startedType":"actual","enrolled":43,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03907852","kind":"trial","name":"Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer","aka":[],"tldr":"A phase 1/2 trial of Fludarabine, Cyclophosphamide, Nivolumab in mesothelioma and ovarian cancer, run by TCR2 Therapeutics, active and no longer recruiting.","summary":"Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer is a phase 1/2 interventional study registered as NCT03907852 by TCR2 Therapeutics, with 57 participants enrolled, started 2019-04-15 and due to reach its primary completion in 2024-11-19. Interventions recorded: gavo-cel, fludarabine, cyclophosphamide, Nivolumab, Ipilimumab. Conditions listed: Mesothelioma, Mesothelioma, Malignant, Mesothelioma; Pleura, Mesotheliomas Pleural. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03907852","url":"https://clinicaltrials.gov/study/NCT03907852"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mesothelioma","ovarian","nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["fludarabine","cyclophosphamide","nivolumab","ipilimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03907852-nat-med-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03907852","phase":"1/2","setting":"A Phase 1/2 Single Arm Open-Label Clinical Trial of Gavocabtagene Autoleucel (Gavo-cel) in Patients With Advanced Mesothelin-Expressing Cancer","sponsor":"TCR2 Therapeutics","started":"2019-04-15","startedType":"actual","enrolled":57,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05786924","kind":"trial","name":"Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies","aka":[],"tldr":"A phase 1/2 trial of fOLFIRI (5-FU, leucovorin, irinotecan), cetuximab, panitumumab, gemcitabine and other drugs in colorectal cancer, run by Institut de Recherches Internationales Servier, now recruiting.","summary":"Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies is a phase 1/2, interventional study registered as NCT05786924 by Institut de Recherches Internationales Servier, with a registry enrolment figure of 554 participants, started 2023-04-18 and due to reach its primary completion in 2028-06. Interventions recorded: S241656; FOLFOX6/FOLFOX7; FOLFIRI; Cetuximab; Panitumumab; Gemcitabine; Nab-paclitaxel. Conditions listed: Non-small Cell Lung Cancer; Histiocytic Neoplasm; Histiocytosis; BRAF Gene Mutation; BRAF V600E; BRAF V600 Mutation; BRAF Mutation-Related Tumors; BRAF; Metastatic Lung Non-Small Cell Carcinoma; Metastatic Lung Cancer; Recurrent Lung Cancer; Recurrent Lung Non-Small Cell Carcinoma; NSCLC; Solid Tumor; Solid Carcinoma; KRAS G12D; KRAS G12V; KRAS Mutation-Related Tumors; NRAS Gene Mutation; Thyroid Cancer; Thyroid Carcinoma; Colorectal Cancer; Colorectal Carcinoma; Recurrent Histiocytic and Dendritic Cell Neoplasm; Brain Metastases; Recurrent NSCLC; KRAS G13C; Acquired Resistance to KRAS G12C Inhibitor; KRAS G12A; KRAS G12F; KRAS G12R; KRAS G13D. Primary outcome: Dose Escalation: Incidence of dose-limiting toxicities (DLTs); Dose Escalation: Number of Adverse Events (AEs) and Serious Adverse Events (SAEs); Dose Optimization/Expansion: Objective response (OR). Colorectal eligibility wording from the registry: \"* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations\". Sites: Australia, China, Denmark, France, Hong Kong, Italy, Japan, Spain, United Kingdom, United States. United Kingdom sites listed: 3. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05786924","url":"https://clinicaltrials.gov/study/NCT05786924"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","braf-v600e-colorectal","kras-g12c-colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["folfiri","cetuximab","panitumumab","gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): University College London Hospital (London); Hammersmith Hospital (London); The Christie NHS Foundation Trust (Manchester)."],"nct":"NCT05786924","phase":"1/2","setting":"A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies","sponsor":"Institut de Recherches Internationales Servier","started":"2023-04-18","startedType":"actual","enrolled":554,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05288205","kind":"trial","name":"Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation","aka":[],"tldr":"A phase 1/2 trial of Glecirasib, Sitneprotafib in non-small-cell lung cancer and small-cell lung cancer, run by Allist Pharmaceuticals, Inc., now recruiting.","summary":"Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation is a phase 1/2 interventional study registered as NCT05288205 by Allist Pharmaceuticals, Inc., with 240 participants planned, started 2022-04-14 and due to reach its primary completion in 2027-03. Interventions recorded: JAB-21822, JAB-3312. Conditions listed: KRAS P.G12C, Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05288205","url":"https://clinicaltrials.gov/study/NCT05288205"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","colorectal","kras-g12c-colorectal","kras-g12c-nsclc"],"sections":[],"technologies":["kinase-inhibitors","kras-inhibitors"],"targets":[],"drugs":["glecirasib","sitneprotafib"],"companies":["allist"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05288205-lancet-respir-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05288205","phase":"1/2","setting":"A Phase 1/2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JAB-21822 in Combination With JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation","sponsor":"Allist Pharmaceuticals, Inc.","started":"2022-04-14","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04643418","kind":"trial","name":"Phase 1/2a Study of MPB-1734 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of MPB-1734 in advanced solid tumours, run by MegaPro Biomedical Co. Ltd., now recruiting.","summary":"Phase 1/2a Study of MPB-1734 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT04643418 by MegaPro Biomedical Co. Ltd., with 81 participants planned, started 2022-03-08 and due to reach its primary completion in 2025-03-31. Interventions recorded: MPB-1734.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04643418","url":"https://clinicaltrials.gov/study/NCT04643418"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04643418","phase":"1/2","setting":"Phase 1/2a Dose-ranging, Safety, Pharmacokinetics, and Preliminary Efficacy Study of MPB-1734 in Patients With Advanced Solid Tumors in Part 1 and With Selected Solid Tumors in Part 2","sponsor":"MegaPro Biomedical Co. Ltd.","started":"2022-03-08","startedType":"actual","enrolled":81,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07504263","kind":"trial","name":"Phase 1/2a Study of RP-001 in Participants With Advanced Malignancies","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Recurv Pharma Inc, not yet recruiting.","summary":"Phase 1/2a Study of RP-001 in Participants With Advanced Malignancies is a phase 1/2, interventional study registered as NCT07504263 by Recurv Pharma Inc, with a registry enrolment figure of 66 participants, started 2026-04-23 and due to reach its primary completion in 2027-12-01. Interventions recorded: RP-001. Conditions listed: Advanced Malignancies; Oncology; Colorectal Cancer; Pancreatic Cancer; Cancer. Primary outcome: To characterize the safety and tolerability of RP-001 administered as monotherapy.. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07504263","url":"https://clinicaltrials.gov/study/NCT07504263"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07504263","phase":"1/2","setting":"An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of RP-001 in Participants With Advanced Malignancies","sponsor":"Recurv Pharma Inc","started":"2026-04-23","startedType":"estimated","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07148128","kind":"trial","name":"Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.","aka":[],"tldr":"A phase 1/2 trial of WEF-001 in pancreatic ductal adenocarcinoma, colorectal cancer and non-small-cell lung cancer, run by Auricula Biosciences Inc., now recruiting.","summary":"Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours. is a phase 1/2 interventional study registered as NCT07148128 by Auricula Biosciences Inc., with 110 participants planned, started 2025-07-28 and due to reach its primary completion in 2028-01. Interventions recorded: WEF-001.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07148128","url":"https://clinicaltrials.gov/study/NCT07148128"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","colorectal","nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07148128","phase":"1/2","setting":"An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of WEF-001 in Participants With Advanced KRAS- Mutant Solid Tumours.","sponsor":"Auricula Biosciences Inc.","started":"2025-07-28","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07415863","kind":"trial","name":"Phase 1/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SYS6043 in advanced solid tumours, run by CSPC Megalith Biopharmaceutical Co.,Ltd., now recruiting.","summary":"Phase 1/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT07415863 by CSPC Megalith Biopharmaceutical Co.,Ltd., with 820 participants planned, started 2024-12-30 and due to reach its primary completion in 2027-12-30. Interventions recorded: SYS6043.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07415863","url":"https://clinicaltrials.gov/study/NCT07415863"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07415863","phase":"1/2","setting":"Phase I/II Dose-Escalation, PK Expansion and Cohort Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SYS6043 in Patients With Advanced/Metastatic Solid Tumors","sponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","started":"2024-12-30","startedType":"actual","enrolled":820,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04787042","kind":"trial","name":"Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067","aka":[],"tldr":"A phase 1/2 trial of Obinutuzumab, Pembrolizumab in melanoma and renal cell carcinoma, run by Simcha IL-18, Inc., now recruiting.","summary":"Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067 is a phase 1/2 interventional study registered as NCT04787042 by Simcha IL-18, Inc., with 316 participants planned, started 2021-08-06 and due to reach its primary completion in 2025-06-30. Interventions recorded: ST-067, Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA], pembrolizumab. Conditions listed: Cancer, Solid Tumor, Melanoma, Renal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04787042","url":"https://clinicaltrials.gov/study/NCT04787042"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","rcc","nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["obinutuzumab","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04787042","phase":"1/2","setting":"A First-In-Human Phase 1/2 Open-Label Study of Intravenous ST-067, Subcutaneous ST-067 with or Without Obinutuzumab Pre-Treatment, and ST-067 in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies","sponsor":"Simcha IL-18, Inc.","started":"2021-08-06","startedType":"actual","enrolled":316,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06162572","kind":"trial","name":"Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)","aka":[],"tldr":"A phase 1/2 trial of Cemiplimab in non-small-cell lung cancer and small-cell lung cancer, run by Servier Bio-Innovation LLC, active and no longer recruiting.","summary":"Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) is a phase 1/2 interventional study registered as NCT06162572 by Servier Bio-Innovation LLC, with 102 participants enrolled, started 2024-08-07 and due to reach its primary completion in 2027-04. Interventions recorded: S095018, S095024, S095029, S095018 Recommended Dose Expansion (RDE), S095024 RDE. Conditions listed: Non-small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06162572","url":"https://clinicaltrials.gov/study/NCT06162572"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["servier"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06162572","phase":"1/2","setting":"A Phase 1b/2, Multicenter, Open-label Platform Study of Select Immunotherapy Combinations in Adult Participants With Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) With High PD-L1 Expression","sponsor":"Servier Bio-Innovation LLC","started":"2024-08-07","startedType":"actual","enrolled":102,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05532696","kind":"trial","name":"Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients","aka":[],"tldr":"A phase 1/2 trial of ABT-101 in non-small-cell lung cancer, run by Anbogen Therapeutics, Inc., now recruiting.","summary":"Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients is a phase 1/2 interventional study registered as NCT05532696 by Anbogen Therapeutics, Inc., with 61 participants planned, started 2022-09-27 and due to reach its primary completion in 2026-11. Interventions recorded: ABT-101.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05532696","url":"https://clinicaltrials.gov/study/NCT05532696"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","her2-mutant-nsclc"],"sections":[],"technologies":[],"targets":["her2"],"drugs":[],"companies":["anbogen-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05532696","phase":"1/2","setting":"A Phase Ib/II, Open-Label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ABT-101 in Patients With Advanced Solid Tumors and HER2 Exon 20 Insertions Mutated Non- Small Cell Lung Cancer","sponsor":"Anbogen Therapeutics, Inc.","started":"2022-09-27","startedType":"actual","enrolled":61,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06938867","kind":"trial","name":"Phase 1b/2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplant Receiving FQ Prophylaxis & Harboring FQR Ecoli Pre-Transplant","aka":[],"tldr":"A phase 1/2 trial of SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli in advanced solid tumours, run by SNIPR Biome Aps., now recruiting.","summary":"Phase 1b/2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplant Receiving FQ Prophylaxis & Harboring FQR Ecoli Pre-Transplant is a phase 1/2 interventional study registered as NCT06938867 by SNIPR Biome Aps., with 24 participants planned, started 2025-02-25 and due to reach its primary completion in 2026-04-01. Interventions recorded: SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06938867","url":"https://clinicaltrials.gov/study/NCT06938867"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06938867","phase":"1/2","setting":"A Phase 1b/2a, Randomized, Double-blind Study to Investigate Safety, Tolerability, PK, PD, and Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplantation Receiving Fluoroquinolone Prophylaxis and Harboring Fluoroquinolone-Resistant Escherichia Coli Pre-Transplant","sponsor":"SNIPR Biome Aps.","started":"2025-02-25","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05103358","kind":"trial","name":"Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)","aka":["PRECISION 1"],"tldr":"A phase 2 trial of Sirolimus protein-bound particles in metastatic cancer, run by Aadi Bioscience, Inc., active and no longer recruiting.","summary":"Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1) is a phase 2 interventional study registered as NCT05103358 by Aadi Bioscience, Inc., with 120 participants planned, started 2022-02-15 and due to reach its primary completion in 2024-12-31. Interventions recorded: nab-sirolimus. Conditions listed: Tumor, Tumor, Solid, Metastasis, Metastatic Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05103358","url":"https://clinicaltrials.gov/study/NCT05103358"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","pecoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["sirolimus-albumin-bound"],"companies":["aadi-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05103358","phase":"2","setting":"A Phase 2 Multi-center Open-label Basket Trial of Nab-sirolimus for Adult and Adolescent Patients With Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 or TSC2 Genes.","sponsor":"Aadi Bioscience, Inc.","started":"2022-02-15","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07168226","kind":"trial","name":"Phase 2 Cachexia Clinical Trial to Evaluate the Efficacy and Safety of ASCA101","aka":[],"tldr":"A phase 2 trial of Active Comparator in advanced solid tumours, run by MetaFines, now recruiting.","summary":"Phase 2 Cachexia Clinical Trial to Evaluate the Efficacy and Safety of ASCA101 is a phase 2 interventional study registered as NCT07168226 by MetaFines, with 135 participants planned, started 2026-05-08 and due to reach its primary completion in 2028-04-30. Interventions recorded: Active Comparator, ASCA101 24.32mg/kg, ASCA101 32.43mg/kg and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07168226","url":"https://clinicaltrials.gov/study/NCT07168226"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07168226","phase":"2","setting":"A Multi-center, Randomized, Phase 2 Clinical Trial to Exploratively Evaluate the Efficacy and Safety of ASCA101 for the Treatment of Cachexia in Patients With Solid Tumor","sponsor":"MetaFines","started":"2026-05-08","startedType":"actual","enrolled":135,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07413601","kind":"trial","name":"Phase 2 Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Platinum Chemotherapy Versus Platinum Chemotherapy in the Treatment of Secon","aka":[],"tldr":"A phase 2 trial of iparomlimab and tuvonralimab, cisplatin and carboplatin in triple-negative breast cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, not yet recruiting.","summary":"Phase 2 Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Platinum Chemotherapy Versus Platinum Chemotherapy in the Treatment of Second-/Third-line Triple Negative Breast Cancer (TNBC) is a phase 2, randomised interventional study registered as NCT07413601 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 78 participants, started 2026-02-10 and due to reach its primary completion in 2029-02-10. Interventions recorded: QL1706; Cisplatin/ Carboplatin. Conditions listed: Triple Negative Breast Cancer Metastatic. Triple-negative eligibility wording from the registry: \"* Locally advanced or metastatic triple negative breast cancer confirmed by histopathology that is not suitable for curative treatment and cannot be treated surgically (Defined as negative for HER2, ER and PR expression according to the latest ASCO/CAP guidelines);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07413601","url":"https://clinicaltrials.gov/study/NCT07413601"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["iparomlimab-tuvonralimab","cisplatin","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07413601","phase":"2","setting":"Phase 2 Randomized Controlled Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Platinum Chemotherapy Versus Platinum Chemotherapy in the Treatment of Second-/Third-line Triple Negative Breast Cancer (TNBC)","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2026-02-10","startedType":"estimated","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05945823","kind":"trial","name":"Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors","aka":[],"tldr":"A phase 2 trial of Futibatinib, Pembrolizumab, Cisplatin and Oxaliplatin in oesophageal cancer and pancreatic ductal adenocarcinoma, run by Taiho Oncology, Inc., active and no longer recruiting.","summary":"Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors is a phase 2 interventional study registered as NCT05945823 by Taiho Oncology, Inc., with 53 participants enrolled, started 2023-07-13 and due to reach its primary completion in 2026-10-01. Interventions recorded: Futibatinib, Pembrolizumab, Cisplatin, 5-FU, Oxaliplatin and Leucovorin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05945823","url":"https://clinicaltrials.gov/study/NCT05945823"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal","pancreatic"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["futibatinib","pembrolizumab","cisplatin","oxaliplatin"],"companies":["araris"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05945823","phase":"2","setting":"A Phase 2 Study of Futibatinib in Combination With PD-1 Antibody-based Standard of Care Therapy in Patients With Solid Tumors.","sponsor":"Taiho Oncology, Inc.","started":"2023-07-13","startedType":"actual","enrolled":53,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03944772","kind":"trial","name":"Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)","aka":["ORCHARD"],"tldr":"A phase 2 trial of Osimertinib, Savolitinib, Gefitinib in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) is a phase 2 interventional study registered as NCT03944772 by AstraZeneca, with 247 participants enrolled, started 2019-06-25 and due to reach its primary completion in 2025-05-06. Interventions recorded: Osimertinib, Savolitinib, Gefitinib, Necitumumab, Durvalumab. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03944772","url":"https://clinicaltrials.gov/study/NCT03944772"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib","savolitinib","gefitinib","necitumumab","durvalumab","carboplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03944772-jco-precis-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03944772","phase":"2","setting":"A Biomarker-directed Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Whose Disease Has Progressed on First-Line Osimertinib Therapy.","sponsor":"AstraZeneca","started":"2019-06-25","startedType":"actual","enrolled":247,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07292298","kind":"trial","name":"Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by University of Colorado, Denver, now recruiting.","summary":"Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates is a phase 2, interventional study registered as NCT07292298 by University of Colorado, Denver, with a registry enrolment figure of 44 participants, started 2026-11 and due to reach its primary completion in 2030-11. Interventions recorded: High Rare Dose Rectal Brachytherapy Boost. Conditions listed: Rectal Adenocarcinoma; Rectal Cancer. Primary outcome: Organ preservation (no surgical requirement) of the rectum associated with complete clinical response. Colorectal eligibility wording from the registry: \"Patients with MMR-proficient low-mid rectal adenocarcinoma cT1-4 N0-2 M0 who underwent total neoadjuvant therapy who have not achieved complete response (i\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07292298","url":"https://clinicaltrials.gov/study/NCT07292298"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07292298","phase":"2","setting":"Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates","sponsor":"University of Colorado, Denver","started":"2026-11","startedType":"estimated","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04268706","kind":"trial","name":"Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT)","aka":["CHARIOT"],"tldr":"A phase 2 trial of Fludarabine, Bendamustine in hodgkin lymphoma, run by Tessa Therapeutics, active and no longer recruiting.","summary":"Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT) is a phase 2 interventional study registered as NCT04268706 by Tessa Therapeutics, with 97 participants planned, started 2021-02-01 and due to reach its primary completion in 2025-05. Interventions recorded: CD30.CAR-T, Fludarabine, Bendamustine. Conditions listed: Hodgkin Lymphoma, Adult, Hodgkin Disease Recurrent, Hodgkin Disease Refractory, Hodgkin Disease, Pediatric. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04268706","url":"https://clinicaltrials.gov/study/NCT04268706"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","relapsed-refractory-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["fludarabine","bendamustine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04268706","phase":"2","setting":"A Phase 2 Multi-Center Study Evaluating the Safety and Efficacy of CD30-Directed Genetically Modified Autologous T Cells (CD30.CAR-T) in Adult and Pediatric Patients With Relapsed or Refractory Classical Hodgkin Lymphoma","sponsor":"Tessa Therapeutics","started":"2021-02-01","startedType":"actual","enrolled":97,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05363280","kind":"trial","name":"Phase 2 Study for the Patient, Who Has Diagnosed With Small Cell Lung Cancer (SCLC) or Non Small Cell Lung Cancer (NSCLC) or Renal Cell Carcinoma (RCC) and Finished the First Line Stand Treatment , Need More Treatment","aka":[],"tldr":"A phase 2 trial of AL8326 40 mg in small-cell lung cancer, renal cell carcinoma and non-small-cell lung cancer, run by Advenchen Pharmaceuticals, LLC., now recruiting.","summary":"Phase 2 Study for the Patient, Who Has Diagnosed With Small Cell Lung Cancer (SCLC) or Non Small Cell Lung Cancer (NSCLC) or Renal Cell Carcinoma (RCC) and Finished the First Line Stand Treatment , Need More Treatment is a phase 2 interventional study registered as NCT05363280 by Advenchen Pharmaceuticals, LLC., with 80 participants planned, started 2022-11-01 and due to reach its primary completion in 2027-12. Interventions recorded: AL8326 40 mg, AL8326 60 mg and AL8326 80 mg--stopped.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05363280","url":"https://clinicaltrials.gov/study/NCT05363280"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","rcc","nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["advenchen-laboratories"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05363280","phase":"2","setting":"A Phase 2 Evaluation of the Safety and Efficacy of Veonetinib (AL8326) in ≥2nd Line Small Cell Lung Cancer (SCLC), Non Small Cell Lung Cancer (NSCLC) and Renal Cell Carcinoma (RCC) Treatment","sponsor":"Advenchen Pharmaceuticals, LLC.","started":"2022-11-01","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07793253","kind":"trial","name":"Phase 2 Study of Daraxonrasib in Recurrent KRAS-Mutant Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of daraxonrasib in gallbladder cancer and other biliary tract cancers, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, not yet recruiting.","summary":"Phase 2 Study of Daraxonrasib in Recurrent KRAS-Mutant Biliary Tract Cancer is a phase 2 interventional study registered as NCT07793253 by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, with a registry enrolment figure of 55 participants, started 2026-11 and due to reach its primary completion in 2030-11. Interventions recorded: Daraxonrasib. Conditions listed: Biliary Tract Cancers, Intrahepatic Cholangiocarcinoma (Icc), Extrahepatic Cholangiocarcinoma, Gallbladder Carcinoma, Ampulla of Vater Carcinoma, Ampullary Carcinoma. Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07793253","url":"https://clinicaltrials.gov/study/NCT07793253"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["daraxonrasib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07793253","phase":"2","setting":"A Multi-Institutional Phase 2 Evaluation of Daraxonrasib in Recurrent KRAS-Mutant Biliary Tract Cancer","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","started":"2026-11","startedType":"estimated","enrolled":55,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07024706","kind":"trial","name":"Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab","aka":["MAVRiC"],"tldr":"A phase 2 trial of Acalabrutinib and Venetoclax in chronic lymphocytic leukaemia, run by AstraZeneca, now recruiting.","summary":"Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab is a phase 2 interventional study registered as NCT07024706 by AstraZeneca, with 80 participants planned, started 2026-06-04 and due to reach its primary completion in 2029-05-01. Interventions recorded: Acalabrutinib and Venetoclax.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07024706","url":"https://clinicaltrials.gov/study/NCT07024706"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["acalabrutinib","venetoclax"],"companies":["astrazeneca","abbvie","flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07024706","phase":"2","setting":"The MAVRiC Study: A Phase II Study of Disease Risk Mutation Guided Finite Duration Acalabrutinib Plus Venetoclax for Relapse in CLL/SLL After First-line Finite Covalent BTKi Plus BCL2i Combination, With or Without Obinutuzumab","sponsor":"AstraZeneca","started":"2026-06-04","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06589440","kind":"trial","name":"Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Can","aka":[],"tldr":"A phase 2 trial of Botensilimab in colorectal cancer, run by Stingray Therapeutics, now recruiting.","summary":"Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC) is a phase 2 interventional study registered as NCT06589440 by Stingray Therapeutics, with 70 participants planned, started 2024-11-20 and due to reach its primary completion in 2027-07-31. Interventions recorded: SR-8541A. Conditions listed: Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06589440","url":"https://clinicaltrials.gov/study/NCT06589440"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["botensilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06589440","phase":"2","setting":"Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)","sponsor":"Stingray Therapeutics","started":"2024-11-20","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06567743","kind":"trial","name":"Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC","aka":[],"tldr":"A phase 2 trial of Cretostimogene grenadenorepvec in bladder & urothelial cancer, run by CG Oncology, Inc., now recruiting.","summary":"Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC is a phase 2 interventional study registered as NCT06567743 by CG Oncology, Inc., with 325 participants planned, started 2024-09-16 and due to reach its primary completion in 2027-03-31. Interventions recorded: Cretostimogene Grenadenorepvec.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06567743","url":"https://clinicaltrials.gov/study/NCT06567743"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["oncolytic-virus"],"targets":[],"drugs":["cretostimogene"],"companies":["cg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06567743","phase":"2","setting":"A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)","sponsor":"CG Oncology, Inc.","started":"2024-09-16","startedType":"actual","enrolled":325,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04613596","kind":"trial","name":"Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G","aka":[],"tldr":"A phase 2/3 trial of Adagrasib, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Mirati Therapeutics Inc., now recruiting.","summary":"Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7 is a phase 2/3 interventional study registered as NCT04613596 by Mirati Therapeutics Inc., with 626 participants planned, started 2020-12-02 and due to reach its primary completion in 2028-10-31. Interventions recorded: Adagrasib, Adagrasib, Adagrasib, Adagrasib, Pembrolizumab. Conditions listed: Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04613596","url":"https://clinicaltrials.gov/study/NCT04613596"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","kras-g12c-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","kras-inhibitors"],"targets":[],"drugs":["adagrasib","pembrolizumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04613596","phase":"2/3","setting":"A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","sponsor":"Mirati Therapeutics Inc.","started":"2020-12-02","startedType":"actual","enrolled":626,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00186628","kind":"trial","name":"Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD","aka":[],"tldr":"A phase 2 trial of Rituximab, Filgrastim and Granisetron in Leukaemia and Mantle cell lymphoma, run by Stanford University, completed.","summary":"Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD is a phase 2 interventional study registered as NCT00186628 by Stanford University, with 36 participants recorded, started 2005-06 and reaching its primary completion in 2010-11. Interventions recorded: Total lymphoid irradiation, Rituximab, Anti-thymoglobulin, rabbit (ATG, rabbit ATG), Cyclosporine, Mycophenylate mofetil, Filgrastim, Granisetron, Solumedrol, Acetaminophen, Diphenhydramine, Hydrocortisone. Conditions recorded: Leukemia, Mast-Cell, Mantle-cell Lymphoma.\n\nLinked to the drug Granisetron because the registry names it among its interventions and Leukaemia and Mantle cell lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00186628","url":"https://clinicaltrials.gov/study/NCT00186628"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia","mantle-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["rituximab","filgrastim","granisetron"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00186628","phase":"2","setting":"An Open-label, Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft Versus Host Disease After TLI/ARG Nonmyeloablative Allogeneic Stem Cell Transplantation","sponsor":"Stanford University","started":"2005-06","yearReported":2017,"enrolled":36,"enrolledBasis":"registry","outcomes":[{"endpoint":"Chronic Graft-vs-Host Disease (cGvHD)","primary":true,"unit":"%","arms":[{"name":"Prophylactic Rituximab","n":35,"value":20,"note":"95% CI 6 to 34; Figures from the ClinicalTrials.gov results section (first posted 2017-11-28), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00186628?tab=results"},{"endpoint":"Overall Survival","unit":"%","arms":[{"name":"Prophylactic Rituximab (CLL Patients)","n":22,"value":73,"note":"95% CI 57 to 94; Figures from the ClinicalTrials.gov results section (first posted 2017-11-28), not from a publication"},{"name":"Prophylactic Rituximab (MCL Patients)","n":13,"value":69,"note":"95% CI 48 to 99"}],"source":"https://clinicaltrials.gov/study/NCT00186628?tab=results"}]},{"id":"nct04291105","kind":"trial","name":"Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients","aka":[],"tldr":"A phase 2 trial of Cemiplimab in melanoma and head and neck squamous cell carcinoma, run by Vyriad, Inc., active and no longer recruiting.","summary":"Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients is a phase 2 interventional study registered as NCT04291105 by Vyriad, Inc., with 87 participants planned, started 2020-04-24 and due to reach its primary completion in 2026-10. Interventions recorded: VV1, Cemiplimab. Conditions listed: Melanoma, Head and Neck Squamous Cell Carcinoma, Colo-rectal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04291105","url":"https://clinicaltrials.gov/study/NCT04291105"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","head-and-neck","colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["vyriad"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04291105","phase":"2","setting":"Phase 2 Trial of Voyager VI (Vesicular Stomatitis Virus Expressing NIS and Human Interferon Beta, VV1), in Combination With Cemiplimab in Patients With Select Solid Tumors","sponsor":"Vyriad, Inc.","started":"2020-04-24","startedType":"actual","enrolled":87,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07106762","kind":"trial","name":"Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy","aka":["IZABRIGHT-Bladder01"],"tldr":"A phase 2/3 trial of Cisplatin, Gemcitabine and Carboplatin in bladder & urothelial cancer, run by Bristol-Myers Squibb, now recruiting.","summary":"Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy is a phase 2/3 interventional study registered as NCT07106762 by Bristol-Myers Squibb, with 470 participants planned, started 2025-09-30 and due to reach its primary completion in 2029-01-26. Interventions recorded: Iza-bren, Cisplatin, Gemcitabine and Carboplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07106762","url":"https://clinicaltrials.gov/study/NCT07106762"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cisplatin","gemcitabine","carboplatin"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07106762","phase":"2/3","setting":"IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment","sponsor":"Bristol-Myers Squibb","started":"2025-09-30","startedType":"actual","enrolled":470,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05864534","kind":"trial","name":"Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma","aka":[],"tldr":"A phase 2 trial of Transcranial focused ultrasound systems in Glioma & glioblastoma, run by Northwestern University, now recruiting.","summary":"Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma is a phase 2 interventional study registered as NCT05864534 by Northwestern University, with 25 participants planned, started 2024-01-19 and due to reach its primary completion in 2031-07-31. Interventions recorded: Balstilimab, Botensilimab, Liposomal Doxorubicin, Sonocloud-9 (SC-9). Conditions recorded: Newly Diagnosed Glioblastoma, Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype, Gliosarcoma, Glioblastoma Multiforme.\n\nLinked to the technology Transcranial focused ultrasound systems because the registry names it (\"sonocloud\") among its interventions and Glioma & glioblastoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05864534","url":"https://clinicaltrials.gov/study/NCT05864534"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["transcranial-focused-ultrasound-systems"],"targets":[],"drugs":["balstilimab","botensilimab","doxorubicin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05864534","phase":"2","setting":"A Phase 2a Trial of Immune Modulation in Combination With Ultrasound-mediated Blood Brain Barrier Opening in Patients With Newly Diagnosed Glioblastoma","sponsor":"Northwestern University","started":"2024-01-19","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06030622","kind":"trial","name":"Phase 2A Pilot C3 Trial of Recurrent/Refractory Metastatic Advanced Pancreatic Cancer","aka":["C3"],"tldr":"A phase 1/2 trial of gemcitabine in pancreatic cancer, run by State University of New York - Downstate Medical Center, now recruiting.","summary":"Phase 2A Pilot C3 Trial of Recurrent/Refractory Metastatic Advanced Pancreatic Cancer is a phase 1/2, interventional study registered as NCT06030622 by State University of New York - Downstate Medical Center, with a registry enrolment figure of 25 participants, started 2024-04-17 and due to reach its primary completion in 2028-12-01. Interventions recorded: Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin); C3 (Metformin, Simvastatin, and Digoxin) only. Conditions listed: Pancreatic Cancer Metastatic. Primary outcome: Primary Outcome: Safety and tolerability. Pancreatic eligibility wording from the registry: \"Subject ≥18 years with histologically confirmed pancreatic cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06030622","url":"https://clinicaltrials.gov/study/NCT06030622"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06030622","phase":"1/2","setting":"Phase 2A Pilot Trial of Metformin, Digoxin, Simvastatin (C3) in Combination With Gemcitabine in Subjects With Recurrent / Refractory Metastatic Advanced Pancreatic Cancer","sponsor":"State University of New York - Downstate Medical Center","started":"2024-04-17","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06777433","kind":"trial","name":"Phase 2b Imaging Study of RAD101 in Participants With Suspected Recurrent Brain Metastases","aka":[],"tldr":"A phase 2 trial of RAD101 (18F-FPIA) in brain and spinal cord tumours, run by Radiopharm Theranostics, Ltd, active and no longer recruiting.","summary":"Phase 2b Imaging Study of RAD101 in Participants With Suspected Recurrent Brain Metastases is a phase 2 interventional study registered as NCT06777433 by Radiopharm Theranostics, Ltd, with 30 participants enrolled, started 2024-12-13 and due to reach its primary completion in 2026-04-23. Interventions recorded: RAD101 (18F-FPIA).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06777433","url":"https://clinicaltrials.gov/study/NCT06777433"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["brain-tumours","secondary-brain-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["medpace","radiopharm-theranostics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06777433","phase":"2","setting":"An Open-Label, Single Dose, Single Arm, Multicenter Phase 2b Study to Establish the Imaging Performance of RAD101 Positron Emission Tomography (PET) in Participants With Suspected Recurrent Brain Metastases From Solid Tumors","sponsor":"Radiopharm Theranostics, Ltd","started":"2024-12-13","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06757634","kind":"trial","name":"Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)","aka":["VIKTORIA-2"],"tldr":"A phase 3 trial of Fulvestrant, Gedatolisib, Palbociclib and Ribociclib in HR-positive / HER2-negative breast cancer, run by Celcuity Inc, now recruiting.","summary":"Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) is a phase 3 interventional study registered as NCT06757634 by Celcuity Inc, with 1180 participants planned, started 2025-07-24 and due to reach its primary completion in 2029-03-31. Interventions recorded: Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole and Arm D: Ribociclib + Letrozole.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06757634","url":"https://clinicaltrials.gov/study/NCT06757634"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["fulvestrant","gedatolisib","palbociclib","ribociclib"],"companies":["celcuity"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06757634","phase":"3","setting":"VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib With Endocrine Therapy and Palbociclib vs Endocrine Therapy and Ribociclib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer","sponsor":"Celcuity Inc","started":"2025-07-24","startedType":"actual","enrolled":1180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04793958","kind":"trial","name":"Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)","aka":["KRYSTAL-10"],"tldr":"A phase 3 trial of Cetuximab in colorectal cancer, run by Mirati Therapeutics Inc., active and no longer recruiting.","summary":"Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10) is a phase 3 interventional study registered as NCT04793958 by Mirati Therapeutics Inc., with 461 participants enrolled, started 2021-06-24 and due to reach its primary completion in 2026-01-16. Interventions recorded: MRTX849, Cetuximab, mFOLFOX6 Regimen, FOLFIRI Regimen. Conditions listed: Advanced Colorectal Cancer, Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04793958","url":"https://clinicaltrials.gov/study/NCT04793958"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","kras-g12c-colorectal"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["cetuximab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":["codebreak-300"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["KRYSTAL-10 is the randomised confirmatory trial for the June 2024 accelerated approval of adagrasib with cetuximab. The registry lists 461 participants, phase 3, sponsored by Mirati Therapeutics, and the status on 24 September 2026 was active but no longer recruiting: second-line adagrasib with cetuximab against investigator-choice chemotherapy (mFOLFOX6 or FOLFIRI) in KRAS G12C-mutated metastatic colorectal cancer."],"nct":"NCT04793958","phase":"3","setting":"A Randomized Phase 3 Study of MRTX849 in Combination With Cetuximab Versus Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation With Disease Progression On or After Standard First-Line Therapy","sponsor":"Mirati Therapeutics Inc.","started":"2021-06-24","startedType":"actual","yearReported":2026,"enrolled":461,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01436968","kind":"trial","name":"Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Aglatimagene besadenovec in prostate cancer, run by Candel Therapeutics, Inc., active and no longer recruiting.","summary":"Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer is a phase 3 interventional study registered as NCT01436968 by Candel Therapeutics, Inc., with 711 participants planned, started 2011-09 and due to reach its primary completion in 2024-08. Interventions recorded: Aglatimagene besadenovec + valacyclovir, Placebo + valacyclovir. Conditions listed: Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01436968","url":"https://clinicaltrials.gov/study/NCT01436968"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["aglatimagene-besadenovec"],"companies":["candel-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct01436968-lancet-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01436968","phase":"3","setting":"A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer","sponsor":"Candel Therapeutics, Inc.","started":"2011-09","enrolled":711,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06982521","kind":"trial","name":"Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer","aka":["ReDiscover-2"],"tldr":"A phase 3 trial testing Zovegalisib in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer is a phase 3 interventional study registered as NCT06982521, led by Relay Therapeutics, and recruiting on the registry. Official title: A Phase 3 Open-Label Randomised Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor. Planned enrolment is 540 participants (estimated). The study started in 2025-08-26 and primary completion is expected in 2028-04-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06982521","url":"https://clinicaltrials.gov/study/NCT06982521"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":[],"targets":[],"drugs":["zovegalisib"],"companies":["relay-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06982521","phase":"3","setting":"A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor","sponsor":"Relay Therapeutics","started":"2025-08-26","startedType":"actual","enrolled":540,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06467357","kind":"trial","name":"Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer","aka":["DESTINY-BTC01"],"tldr":"A phase 3 trial of Gemcitabine, Cisplatin, Durvalumab, Trastuzumab deruxtecan and Rilvegostomig in biliary tract cancer, run by AstraZeneca, now recruiting.","summary":"Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer is a phase 3 interventional study registered as NCT06467357 by AstraZeneca, with 620 participants planned, started 2024-08-12 and due to reach its primary completion in 2028-06-12. Interventions recorded: Gemcitabine, Cisplatin, Durvalumab, Trastuzumab deruxtecan and Rilvegostomig.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06467357","url":"https://clinicaltrials.gov/study/NCT06467357"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["adc","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["gemcitabine","cisplatin","durvalumab","trastuzumab-deruxtecan","rilvegostomig"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06467357","phase":"3","setting":"DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer","sponsor":"AstraZeneca","started":"2024-08-12","startedType":"actual","enrolled":620,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07154706","kind":"trial","name":"Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)","aka":["TRUST-IV"],"tldr":"A phase 3 trial of Taletrectinib in non-small-cell lung cancer and small-cell lung cancer, run by Nuvation Bio Inc., now recruiting.","summary":"Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV) is a phase 3 interventional study registered as NCT07154706 by Nuvation Bio Inc., with 180 participants planned, started 2025-08-21 and due to reach its primary completion in 2030-08-30. Interventions recorded: Taletrectinib, Placebo. Conditions listed: Non-small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07154706","url":"https://clinicaltrials.gov/study/NCT07154706"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc","ros1-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["taletrectinib"],"companies":["nuvation-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07154706","phase":"3","setting":"A Phase 3 Multicenter Double-blind Randomized Study of Taletrectinib Versus Placebo in Patients With ROS1-Fusion Positive Stage IB-IIIA Non-Small Cell Lung Cancer Who Have Undergone Complete Tumor Resection","sponsor":"Nuvation Bio Inc.","started":"2025-08-21","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07197580","kind":"trial","name":"Phase 3 Study to Assess Safety and Efficacy of 177Lu-TLX250 in Advanced Relapsed or Recurrent ccRCC","aka":["LUTEON"],"tldr":"A phase 3 trial of 177Lu-TLX250 in renal cell carcinoma, run by Telix Pharmaceuticals (Innovations) Pty Limited, now recruiting.","summary":"Phase 3 Study to Assess Safety and Efficacy of 177Lu-TLX250 in Advanced Relapsed or Recurrent ccRCC is a phase 3 interventional study registered as NCT07197580 by Telix Pharmaceuticals (Innovations) Pty Limited, with 40 participants planned, started 2026-03-25 and due to reach its primary completion in 2027-08-31. Interventions recorded: 177Lu-TLX250.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07197580","url":"https://clinicaltrials.gov/study/NCT07197580"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc","clear-cell-rcc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["medpace"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07197580","phase":"3","setting":"A Phase 3, Randomized, Multi-Center, Open-Label Study to Compare 177Lu-TLX250 (Lutetium (177Lu) Girentuximab Tetraxetan) With the Investigator's Choice of a Single Agent Therapy in Participants With Carbonic Anhydrase 9 (CAIX) Expressing, Advanced Relapsed or Recurrent Clear Cell Renal Cell Carcinoma (ccRCC)","sponsor":"Telix Pharmaceuticals (Innovations) Pty Limited","started":"2026-03-25","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05232916","kind":"trial","name":"Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects","aka":["FLAMINGO-01"],"tldr":"A phase 3 trial testing GLSI-100 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects is a phase 3 interventional study registered as NCT05232916, led by Greenwich LifeSciences, and recruiting on the registry. Official title: A Randomised, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects With Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01). Planned enrolment is 2250 participants (estimated). The study started in 2022-12-16 and primary completion is expected in 2031-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05232916","url":"https://clinicaltrials.gov/study/NCT05232916"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["glsi-100"],"companies":["greenwich-lifesciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05232916","phase":"3","setting":"A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects With Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)","sponsor":"Greenwich LifeSciences","started":"2022-12-16","startedType":"actual","enrolled":2250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06915025","kind":"trial","name":"Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Pat","aka":["OVATION-3"],"tldr":"A phase 3 trial of Paclitaxel / nab-paclitaxel, Carboplatin, Olaparib in ovarian cancer, run by Imunon, now recruiting.","summary":"Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer is a phase 3 interventional study registered as NCT06915025 by Imunon, with 500 participants planned, started 2025-07-09 and due to reach its primary completion in 2032-10-31. Interventions recorded: IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer), Paclitaxel, Carboplatin, Olaparib, Niraparib. Conditions listed: Epithelial Ovarian Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06915025","url":"https://clinicaltrials.gov/study/NCT06915025"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["il12-electroporation"],"targets":[],"drugs":["paclitaxel","carboplatin","olaparib","niraparib"],"companies":["imunon"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06915025","phase":"3","setting":"A Randomized Phase 3 Trial Evaluating the Safety & Efficacy of IP IMNN-001 Administered in Combination w/ Standard Neoadjuvant & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer","sponsor":"Imunon","started":"2025-07-09","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07242274","kind":"trial","name":"Phase 3 Trial of JMKX001899 Versus Docetaxel in Previously Treated Advanced or Metastatic KRAS G12C-Mutant NSCLC","aka":[],"tldr":"A phase 3 trial of docetaxel in lung cancer, run by Jemincare, not yet recruiting.","summary":"Phase 3 Trial of JMKX001899 Versus Docetaxel in Previously Treated Advanced or Metastatic KRAS G12C-Mutant NSCLC is a phase 3, randomised interventional study registered as NCT07242274 by Jemincare, with a registry enrolment figure of 472 participants, started 2025-12-31 and due to reach its primary completion in 2027-12-31. Interventions recorded: JMKX001899; Docetaxel. Conditions listed: NSCLC (Non-small Cell Lung Cancer). Primary outcome: PFS. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed NSCLC\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07242274","url":"https://clinicaltrials.gov/study/NCT07242274"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["kras-g12c-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07242274","phase":"3","setting":"A Multicenter, Randomized, Open-Label, Phase 3 Study Evaluating the Efficacy and Safety of JMKX001899 Versus Docetaxel in Previously Treated Patients With KRAS G12C-Mutant Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Jemincare","started":"2025-12-31","startedType":"estimated","enrolled":472,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07723469","kind":"trial","name":"Phase 3 Trial of SRG-514 Administered Intraoperatively to Patients Undergoing Breast-Conserving Surgery","aka":[],"tldr":"A phase 3 trial in triple-negative breast cancer, run by SURGE Therapeutics, not yet recruiting.","summary":"Phase 3 Trial of SRG-514 Administered Intraoperatively to Patients Undergoing Breast-Conserving Surgery is a phase 3, randomised interventional study registered as NCT07723469 by SURGE Therapeutics, with a registry enrolment figure of 400 participants, started 2026-10 and due to reach its primary completion in 2034-10. Interventions recorded: BCS + SRG-514; BCS. Conditions listed: TNBC - Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Eligible participants will be adults (≥18 years old) who have a history of histologically confirmed diagnosis of TNBC (clinical stage II-III), except inflammatory breast cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07723469","url":"https://clinicaltrials.gov/study/NCT07723469"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07723469","phase":"3","setting":"A Randomized, Phase 3 Trial of SRG-514 Administered Intraoperatively to the Site of Tumor Resection in Patients Undergoing Breast-Conserving Surgery for Triple Negative Breast Cancer","sponsor":"SURGE Therapeutics","started":"2026-10","startedType":"estimated","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07778316","kind":"trial","name":"Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)","aka":["DeLLphi-315"],"tldr":"A phase 3 trial of Tarlatamab in small-cell lung cancer, run by Amgen, now recruiting.","summary":"Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC) is a phase 3 interventional study registered as NCT07778316 by Amgen, with 400 participants planned, started 2026-08-31 and due to reach its primary completion in 2027-09-24. Interventions recorded: Tarlatamab. Conditions listed: Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07778316","url":"https://clinicaltrials.gov/study/NCT07778316"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["tarlatamab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07778316","phase":"3","setting":"A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants With Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-315)","sponsor":"Amgen","started":"2026-08-28","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06118788","kind":"trial","name":"Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia","aka":[],"tldr":"A phase 1/2 trial of BG1805 in acute myeloid leukaemia, run by Guangzhou Bio-gene Technology Co., Ltd, now recruiting.","summary":"Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia is a phase 1/2 interventional study registered as NCT06118788 by Guangzhou Bio-gene Technology Co., Ltd, with 24 participants planned, started 2024-03-07 and due to reach its primary completion in 2027-03. Interventions recorded: BG1805.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06118788","url":"https://clinicaltrials.gov/study/NCT06118788"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06118788","phase":"1/2","setting":"A Single-arm, Dose-escalation and Dose-expansion Phase I Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia","sponsor":"Guangzhou Bio-gene Technology Co., Ltd","started":"2024-03-07","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06105021","kind":"trial","name":"Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor","aka":[],"tldr":"A phase 1/2 trial of AFNT-211 in pancreatic ductal adenocarcinoma, non-small-cell lung cancer and colorectal cancer, run by Affini-T Therapeutics, Inc., active and no longer recruiting.","summary":"Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor is a phase 1/2 interventional study registered as NCT06105021 by Affini-T Therapeutics, Inc., with 100 participants enrolled, started 2024-03-06 and due to reach its primary completion in 2025-12. Interventions recorded: AFNT-211.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06105021","url":"https://clinicaltrials.gov/study/NCT06105021"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","nsclc","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["affini-t-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06105021","phase":"1/2","setting":"Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor","sponsor":"Affini-T Therapeutics, Inc.","started":"2024-03-06","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07008703","kind":"trial","name":"Phase I Study of sss40 Injection for Moderate-to-Severe Bone Metastatic Cancer Pain","aka":[],"tldr":"A phase 1/2 trial of Injection of humanized nerve growth factor (NGF) antibody in advanced solid tumours, run by Shenyang Sunshine Pharmaceutical Co., LTD., now recruiting.","summary":"Phase I Study of sss40 Injection for Moderate-to-Severe Bone Metastatic Cancer Pain is a phase 1/2 interventional study registered as NCT07008703 by Shenyang Sunshine Pharmaceutical Co., LTD., with 132 participants planned, started 2024-03-27 and due to reach its primary completion in 2025-12. Interventions recorded: Injection of humanized nerve growth factor (NGF) antibody.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07008703","url":"https://clinicaltrials.gov/study/NCT07008703"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["3sbio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07008703","phase":"1/2","setting":"Phase Ib/IIa Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetic Characteristics of SSS40 in Subjects With Moderate to Severe Bone Metastasis Cancer Pain","sponsor":"Shenyang Sunshine Pharmaceutical Co., LTD.","started":"2024-03-27","startedType":"actual","enrolled":132,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05700084","kind":"trial","name":"Phase I-II Clinical Trial of Utidelone Capsule in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Capecitabine in advanced solid tumours, run by Beijing Biostar Pharmaceuticals Co., Ltd., active and no longer recruiting.","summary":"Phase I-II Clinical Trial of Utidelone Capsule in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05700084 by Beijing Biostar Pharmaceuticals Co., Ltd., with 84 participants enrolled, started 2023-06-09 and due to reach its primary completion in 2025-10-08. Interventions recorded: Utidelone Capsule (Part 1), Drug A Utidelone Capsule (Part 2: Group A-B), Drug A Utidelone Capsule (Part 2: Group B-A), Drug B Utidelone Injection (Part 2: Group A-B), Drug B Utidelone Injection (Part 2: Group B-A) and Capecitabine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05700084","url":"https://clinicaltrials.gov/study/NCT05700084"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine","utidelone"],"companies":["biostar-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05700084","phase":"1/2","setting":"Phase I-II Clinical Trial on Tolerability and Bioavailability of Utidelone Capsule in Patients With Advanced Solid Tumors","sponsor":"Beijing Biostar Pharmaceuticals Co., Ltd.","started":"2023-06-09","startedType":"actual","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04152499","kind":"trial","name":"Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)","aka":[],"tldr":"A phase 1/2 trial of Sacituzumab tirumotecan in ovarian cancer and non-small-cell lung cancer, run by Klus Pharma Inc., active and no longer recruiting.","summary":"Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01) is a phase 1/2 interventional study registered as NCT04152499 by Klus Pharma Inc., with 1410 participants enrolled, started 2020-02-28 and due to reach its primary completion in 2026-12-31. Interventions recorded: SKB264. Conditions listed: Epithelial Ovarian Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Urothelial Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04152499","url":"https://clinicaltrials.gov/study/NCT04152499"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","nsclc","sclc","head-and-neck","cervical"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04152499-j-hematol-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04152499","phase":"1/2","setting":"A Phase I-II, First-in-Human Study of SKB264 in Patients With Locally Advanced Unresectable /Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies","sponsor":"Klus Pharma Inc.","started":"2020-02-28","startedType":"actual","enrolled":1410,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06735144","kind":"trial","name":"Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of FH-006 in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors is a phase 1/2 interventional study registered as NCT06735144 by Jiangsu HengRui Medicine Co., Ltd., with 200 participants planned, started 2024-12-23 and due to reach its primary completion in 2027-12. Interventions recorded: FH-006.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06735144","url":"https://clinicaltrials.gov/study/NCT06735144"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06735144","phase":"1/2","setting":"A Multicenter, Open Label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of FH-006 for Injection in Patients With Malignant Solid Tumors","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2024-12-23","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06144671","kind":"trial","name":"Phase I/II Clinical Study of GT201 Injection as Monotherapy or in Combination With PD-1 Inhibitor for Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of GT201 in advanced solid tumours, run by Grit Biotechnology, now recruiting.","summary":"Phase I/II Clinical Study of GT201 Injection as Monotherapy or in Combination With PD-1 Inhibitor for Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06144671 by Grit Biotechnology, with 78 participants planned, started 2025-11-01 and due to reach its primary completion in 2027-12-30. Interventions recorded: GT201, IL-2 and PD-1 inhibitor.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06144671","url":"https://clinicaltrials.gov/study/NCT06144671"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["pd1"],"drugs":[],"companies":["grit-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06144671","phase":"1/2","setting":"Phase I/II Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Injection (GT201 Injection) as Monotherapy or in Combination With PD-1 Inhibitor for Advanced Solid Tumors","sponsor":"Grit Biotechnology","started":"2025-11-01","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07280832","kind":"trial","name":"Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma and Urinary Tract Tumors","aka":[],"tldr":"A phase 1/2 trial of JMT108 in melanoma, run by Shanghai JMT-Bio Inc., now recruiting.","summary":"Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma and Urinary Tract Tumors is a phase 1/2 interventional study registered as NCT07280832 by Shanghai JMT-Bio Inc., with 500 participants planned, started 2025-12-17 and due to reach its primary completion in 2026-11-30. Interventions recorded: JMT108.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07280832","url":"https://clinicaltrials.gov/study/NCT07280832"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07280832","phase":"1/2","setting":"Open-Label, Multicenter Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT108 Injection in Participants With Unresectable or Metastatic Melanoma and Urinary Tract Tumors","sponsor":"Shanghai JMT-Bio Inc.","started":"2025-12-17","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07073534","kind":"trial","name":"Phase I/II Clinical Study of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors","aka":[],"tldr":"A phase 1/2 trial of Adebrelimab and SHR-1501 in advanced solid tumours, run by Shanghai Hengrui Pharmaceutical Co., Ltd., now recruiting.","summary":"Phase I/II Clinical Study of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors is a phase 1/2 interventional study registered as NCT07073534 by Shanghai Hengrui Pharmaceutical Co., Ltd., with 203 participants planned, started 2025-07-24 and due to reach its primary completion in 2027-12. Interventions recorded: SHR-1501, Adebrelimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07073534","url":"https://clinicaltrials.gov/study/NCT07073534"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["adebrelimab","shr-1501"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07073534","phase":"1/2","setting":"Phase I/II Clinical Study on the Tolerability, Safety and Efficacy of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","started":"2025-07-24","startedType":"actual","enrolled":203,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06088004","kind":"trial","name":"Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Toripalimab in advanced solid tumours, run by Suzhou Abogen Biosciences Co., Ltd., now recruiting.","summary":"Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06088004 by Suzhou Abogen Biosciences Co., Ltd., with 218 participants planned, started 2023-09-28 and due to reach its primary completion in 2026-12-30. Interventions recorded: ABO2011 Injection and Toripalimab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06088004","url":"https://clinicaltrials.gov/study/NCT06088004"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06088004","phase":"1/2","setting":"A Phase I/II Clinical Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics (PK/PD) and Preliminary Efficacy of ABO2011 Monotherapy or in Combination With Toripalimab in Patients With Advanced Solid Tumors","sponsor":"Suzhou Abogen Biosciences Co., Ltd.","started":"2023-09-28","startedType":"actual","enrolled":218,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06819215","kind":"trial","name":"Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of VB15010 in ovarian cancer, prostate cancer, pancreatic ductal adenocarcinoma, biliary tract cancer and colorectal cancer, run by Zhejiang Yangli Pharmaceutical Technology Co., Ltd., now recruiting.","summary":"Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06819215 by Zhejiang Yangli Pharmaceutical Technology Co., Ltd., with 188 participants planned, started 2024-10-30 and due to reach its primary completion in 2025-12-30. Interventions recorded: VB15010.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06819215","url":"https://clinicaltrials.gov/study/NCT06819215"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","prostate","pancreatic","cholangiocarcinoma","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["vb15010"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06819215","phase":"1/2","setting":"Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Preliminary Efficacy of VB15010 Tablets In Patients With Advanced Solid Tumors","sponsor":"Zhejiang Yangli Pharmaceutical Technology Co., Ltd.","started":"2024-10-30","startedType":"actual","enrolled":188,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05990452","kind":"trial","name":"Phase I/II FIH Study of 9MW2921 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of 9MW2921 in advanced solid tumours, run by Mabwell (Shanghai) Bioscience Co., Ltd., active and no longer recruiting.","summary":"Phase I/II FIH Study of 9MW2921 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05990452 by Mabwell (Shanghai) Bioscience Co., Ltd., with 261 participants enrolled, started 2023-08-28 and due to reach its primary completion in 2026-09-01. Interventions recorded: 9MW2921.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05990452","url":"https://clinicaltrials.gov/study/NCT05990452"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["mabwell-shanghai-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05990452","phase":"1/2","setting":"A Phase I/II First-in-human Study of 9MW2921 to Evaluate the Safety, Tolerability and Preliminary Efficacy of 9MW2921 in Patients With Advanced Solid Tumors","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","started":"2023-08-28","startedType":"actual","enrolled":261,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06212076","kind":"trial","name":"Phase I/II Study of IPG1094 in Advanced Solid Tumors Patients","aka":[],"tldr":"A phase 1/2 trial of IPG1094 in advanced solid tumours, run by Nanjing Immunophage Biotech Co., Ltd, now recruiting.","summary":"Phase I/II Study of IPG1094 in Advanced Solid Tumors Patients is a phase 1/2 interventional study registered as NCT06212076 by Nanjing Immunophage Biotech Co., Ltd, with 60 participants planned, started 2024-07-11 and due to reach its primary completion in 2027-07-09. Interventions recorded: IPG1094.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06212076","url":"https://clinicaltrials.gov/study/NCT06212076"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ipg1094"],"companies":["nanjing-immunophage-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06212076","phase":"1/2","setting":"A Phase I/II, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic Characteristics and Initial Anti-tumor Activity of IPG1094 in Patients With Advanced Solid Tumors","sponsor":"Nanjing Immunophage Biotech Co., Ltd","started":"2024-07-11","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07063329","kind":"trial","name":"Phase I/II Study of PLB1004 Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive","aka":[],"tldr":"A phase 1/2 trial in lung cancer, run by Avistone Pharmaceutical（Ningbo）Co., LTD., not yet recruiting.","summary":"Phase I/II Study of PLB1004 Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive is a phase 1/2, interventional study registered as NCT07063329 by Avistone Pharmaceutical（Ningbo）Co., LTD., with a registry enrolment figure of 108 participants, started 2025-08-08 and due to reach its primary completion in 2028-03-08. Interventions recorded: PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy; PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy; RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy; RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy. Conditions listed: NSCLC (Non-small Cell Lung Cancer). Primary outcome: Phase Ib： Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]); Phase Ib： Incidence of dose-limiting toxicities (DLT) as defined in the protocol; Phase Ib： Recommended Phase II Dose (RP2D). Lung eligibility wording from the registry: \"Phase Ib Dose-escalation Part : Patients with histologically or cytologically confirmed unresectable locally advanced (stage IIIB and IIIC) or metastatic (stage IV) NSCLC (according to the eighth edition of the AJCC lung cancer staging criteria) who have disease progression or intolerance after prev\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07063329","url":"https://clinicaltrials.gov/study/NCT07063329"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["avistone-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07063329","phase":"1/2","setting":"An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetic of PLB1004 Capsules Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive NSCLC","sponsor":"Avistone Pharmaceutical（Ningbo）Co., LTD.","started":"2025-08-08","startedType":"estimated","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03960840","kind":"trial","name":"Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL","aka":[],"tldr":"A phase 1/2 trial of Ibrutinib in diffuse large b-cell lymphoma, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL is a phase 1/2 interventional study registered as NCT03960840 by Novartis Pharmaceuticals, with 217 participants enrolled, started 2019-06-26 and due to reach its primary completion in 2027-06-30. Interventions recorded: Rapcabtagene autoleucel single agent, Ibrutinib. Conditions listed: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Diffuse Large B-cell Lymphoma, Acute Lymphoblastic Leukemia. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03960840","url":"https://clinicaltrials.gov/study/NCT03960840"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ibrutinib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03960840","phase":"1/2","setting":"Phase I/II, Open Label, Multicenter Study of Rapcabtagene Autoleucel in Adult Patients With CLL/SLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL","sponsor":"Novartis Pharmaceuticals","started":"2019-06-26","startedType":"actual","enrolled":217,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07050641","kind":"trial","name":"Phase I/II Study of SCTB39-1 in Advanced Solid Tumours","aka":[],"tldr":"A phase 1/2 trial of SCTB39-1 in advanced solid tumours, run by Sinocelltech Ltd., now recruiting.","summary":"Phase I/II Study of SCTB39-1 in Advanced Solid Tumours is a phase 1/2 interventional study registered as NCT07050641 by Sinocelltech Ltd., with 110 participants planned, started 2025-06-23 and due to reach its primary completion in 2028-06-30. Interventions recorded: SCTB39-1.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07050641","url":"https://clinicaltrials.gov/study/NCT07050641"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sinocelltech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07050641","phase":"1/2","setting":"An Open Multi-center Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39-1 in Adult Patients With Advanced Malignant Solid Tumours","sponsor":"Sinocelltech Ltd.","started":"2025-06-23","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06149481","kind":"trial","name":"Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Can","aka":["STAR15"],"tldr":"A phase 1/2 trial of retifanlimab and nogapendekin alfa inbakicept in colorectal cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC) is a phase 1/2, interventional study registered as NCT06149481 by National Cancer Institute (NCI), with a registry enrolment figure of 60 participants, started 2024-03-26 and due to reach its primary completion in 2027-10-31. Interventions recorded: Retifanlimab; Therapeutic CEA, Brachyury and MUC1 TriAdeno Vaccine Platform; N-803; SX-682. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Phase I: Safety profiles of the IO regimens consisting of retifanlimab, TriAdeno vaccine, N-803 (A1), and retifanlimab, TriAdeno vaccine, N-803, SX-682 (A2) in participants with metastatic colorectal cancer; Phase II: Overall response rate (ORR) defined as the CR+PR of the IO regimen in mCRC. Colorectal eligibility wording from the registry: \"* Participants with histologically confirmed colorectal cancer and evidence of metastatic disease\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06149481","url":"https://clinicaltrials.gov/study/NCT06149481"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","shared-antigen-vaccine"],"targets":[],"drugs":["retifanlimab","nogapendekin-alfa"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06149481","phase":"1/2","setting":"Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)","sponsor":"National Cancer Institute (NCI)","started":"2024-03-26","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06730009","kind":"trial","name":"Phase I/II Study: Allogeneic NK-cell Therapy With Chemotherapy for Post-Surgery PDA or Cholangiocarcinoma Patients","aka":[],"tldr":"A phase 1/2 trial of SLOG + Allogeneic NK cell in pancreatic ductal adenocarcinoma and biliary tract cancer, run by Medigen Biotechnology Corporation, now recruiting.","summary":"Phase I/II Study: Allogeneic NK-cell Therapy With Chemotherapy for Post-Surgery PDA or Cholangiocarcinoma Patients is a phase 1/2 interventional study registered as NCT06730009 by Medigen Biotechnology Corporation, with 42 participants planned, started 2024-10-21 and due to reach its primary completion in 2029-01-31. Interventions recorded: SLOG + Allogeneic NK cell and SLOG chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06730009","url":"https://clinicaltrials.gov/study/NCT06730009"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06730009","phase":"1/2","setting":"A Dose-Finding Phase I Followed by a Phase II Study to Evaluate the Safety and Efficacy of Allogeneic NK-cell Combined With Chemotherapy in Patients With PDA or Cholangiocarcinoma After Surgery","sponsor":"Medigen Biotechnology Corporation","started":"2024-10-21","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06110572","kind":"trial","name":"Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation","aka":["TESSERACT"],"tldr":"A phase 1/2 trial of carboplatin, atezolizumab and etoposide in lung cancer, run by Vanderbilt-Ingram Cancer Center, now recruiting.","summary":"Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation is a phase 1/2, interventional study registered as NCT06110572 by Vanderbilt-Ingram Cancer Center, with a registry enrolment figure of 18 participants, started 2024-04-24 and due to reach its primary completion in 2027-06-30. Interventions recorded: Carboplatin; Atezolizumab; Etoposide; Total Body Irradiation; Hypofractionated Radiation Therapy; Magnetic Resonance Imaging. Conditions listed: Extensive Stage Lung Small Cell Carcinoma; Stage IV Lung Cancer. Primary outcome: Rates of treatment-related adverse events; Progression-free survival. Lung eligibility wording from the registry: \"* Histologically documented or cytologically confirmed diagnosis of extensive stage small-celllung cancer with evaluable disease per RECIST v1\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06110572","url":"https://clinicaltrials.gov/study/NCT06110572"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["carboplatin","atezolizumab","etoposide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06110572","phase":"1/2","setting":"(TESSERACT): Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation (TBI)","sponsor":"Vanderbilt-Ingram Cancer Center","started":"2024-04-24","startedType":"actual","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02802423","kind":"trial","name":"Phase I/II, Evaluate the Safety and Efficacy of BLEX 404 With Docetaxel in Patients With Advanced/Metastatic Triple Negative Breast Cancer.","aka":[],"tldr":"A phase 1/2 trial in triple-negative breast cancer, run by BioLite, Inc., not yet recruiting.","summary":"Phase I/II, Evaluate the Safety and Efficacy of BLEX 404 With Docetaxel in Patients With Advanced/Metastatic Triple Negative Breast Cancer. is a phase 1/2, interventional study registered as NCT02802423 by BioLite, Inc., with a registry enrolment figure of 44 participants, started 2027-01-01 and due to reach its primary completion in 2028-04-30. Interventions recorded: BLEX 404 Oral Liquid. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Patients with histologically or pathologically diagnosed with advanced/metastatic triple negative (ER-, PR-, and HER2-negative) breast cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02802423","url":"https://clinicaltrials.gov/study/NCT02802423"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02802423","phase":"1/2","setting":"A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase IIA Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid With Adjuvant Chemotherapy in Patients With Triple Negative Breast Cancer (TNBC) After Surgery","sponsor":"BioLite, Inc.","started":"2027-01-01","startedType":"estimated","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05797168","kind":"trial","name":"Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors","aka":["FONTANA"],"tldr":"A phase 1/2 trial of AZD5335, Saruparib, Bevacizumab in ovarian cancer and endometrial cancer, run by AstraZeneca, now recruiting.","summary":"Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors is a phase 1/2 interventional study registered as NCT05797168 by AstraZeneca, with 602 participants planned, started 2023-06-05 and due to reach its primary completion in 2028-08-04. Interventions recorded: Torvutatug samrotecan, Saruparib, Bevacizumab, Carboplatin, Palacaparib. Conditions listed: Ovarian Cancer, Lung Adenocarcinoma, Endometrial Cancer, Lung Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05797168","url":"https://clinicaltrials.gov/study/NCT05797168"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","endometrial"],"sections":[],"technologies":[],"targets":[],"drugs":["azd5335","saruparib","bevacizumab","carboplatin","palacaparib","pembrolizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05797168","phase":"1/2","setting":"A Modular Phase I/IIa, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors","sponsor":"AstraZeneca","started":"2023-06-05","startedType":"actual","enrolled":602,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06861452","kind":"trial","name":"Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcinoma","aka":["SNIPER"],"tldr":"A phase 1/2 trial in pancreatic cancer, run by EIR Biotherapies s.r.l., now recruiting.","summary":"Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcinoma is a phase 1/2, interventional study registered as NCT06861452 by EIR Biotherapies s.r.l., with a registry enrolment figure of 9 participants, started 2025-06-25 and due to reach its primary completion in 2027-07-29. Interventions recorded: RR001. Conditions listed: Locally Advanced Pancreatic Adenocarcinoma. Primary outcome: Evaluation of Safety in terms of monitoring of systemic tolerance, Adverse Events (AEs) and severe AEs (SAEs) assess by CTCAE (Version 5.0). Pancreatic eligibility wording from the registry: \"* Patients with confirmed pancreatic ductal adenocarcinoma classified as locally advanced pancreatic adenocarcinoma (LPAC)\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06861452","url":"https://clinicaltrials.gov/study/NCT06861452"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06861452","phase":"1/2","setting":"RR001 in Combination With Chemotherapy for Patients With Locally Advanced Pancreatic Adenocarcinoma: Open-label, Non-randomized Dose Escalation Phase I/IIa Study","sponsor":"EIR Biotherapies s.r.l.","started":"2025-06-25","startedType":"actual","enrolled":9,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06454448","kind":"trial","name":"Phase Ib/II Clinical Study of Adebrelimab in Combination With Decitabine, Albumin-bound Paclitaxel, and Gemcitabine for the First-line Treatment of Metastatic P","aka":[],"tldr":"A phase 1/2 trial of adebrelimab and decitabine in pancreatic cancer, run by Tianjin Medical University Cancer Institute and Hospital, now recruiting.","summary":"Phase Ib/II Clinical Study of Adebrelimab in Combination With Decitabine, Albumin-bound Paclitaxel, and Gemcitabine for the First-line Treatment of Metastatic Pancreatic Cancer is a phase 1/2, interventional study registered as NCT06454448 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 20 participants, started 2024-06-15 and due to reach its primary completion in 2025-06. Interventions recorded: Adebrelimab;decitabine;. Conditions listed: Adebrelimab (SHR-1316); Decitabine; Metastatic Pancreatic Cancer. Primary outcome: Dose Limiting Toxicity (DLT); The recommended phase 2 dose (RP2D); Objective Response Rate (ORR). Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed diagnosis of pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records showing metastatic pancreatic cancer (stage IV according to the AJCC 8th edition TNM staging of pancreatic cancer); 3\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06454448","url":"https://clinicaltrials.gov/study/NCT06454448"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab","decitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06454448","phase":"1/2","setting":"Phase Ib/II Clinical Study of Adebrelimab in Combination With Decitabine, Albumin-bound Paclitaxel, and Gemcitabine for the First-line Treatment of Metastatic Pancreatic Cancer","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2024-06-15","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07235176","kind":"trial","name":"Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients","aka":[],"tldr":"A phase 1/2 trial of Fulvestrant in advanced solid tumours, run by Qilu Pharmaceutical Co., Ltd., now recruiting.","summary":"Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients is a phase 1/2 interventional study registered as NCT07235176 by Qilu Pharmaceutical Co., Ltd., with 300 participants planned, started 2026-01-16 and due to reach its primary completion in 2028-11-02. Interventions recorded: QLS1304 tablet+Fulvestrant or QLC1401 and QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07235176","url":"https://clinicaltrials.gov/study/NCT07235176"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["fulvestrant"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07235176","phase":"1/2","setting":"A Phase Ib/II Clinical Study to Evaluate Safety, Preliminary Efficacy and PK Characteristic of QLS1304 Combined With Endocrine Therapy in ER+/HER2- Breast Cancer Patients","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2026-01-16","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07239596","kind":"trial","name":"Phase Ib/II Clinical Study of SHR-8068 Combined Anti-tumor Drugs in the Treatment of Advanced Renal Cell Carcinom","aka":[],"tldr":"A phase 1/2 trial of SHR-8068 in renal cell carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"Phase Ib/II Clinical Study of SHR-8068 Combined Anti-tumor Drugs in the Treatment of Advanced Renal Cell Carcinom is a phase 1/2 interventional study registered as NCT07239596 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 92 participants planned, started 2026-01-06 and due to reach its primary completion in 2030-12. Interventions recorded: SHR-8068；Adebrelimab ；Bevacizumab, SHR-8068 ; SHR-4610. Conditions listed: Advanced Renal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07239596","url":"https://clinicaltrials.gov/study/NCT07239596"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-8068"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07239596","phase":"1/2","setting":"An Open, Multicenter Phase Ib/II Clinical Study of SHR-8068 in Combination Anti-tumor Drugs for the Treatment of Advanced Renal Cell Carcinoma","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2026-01-06","startedType":"actual","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03260023","kind":"trial","name":"Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers","aka":[],"tldr":"A phase 1/2 trial of Avelumab in penile cancer, run by Transgene, active and no longer recruiting.","summary":"Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers is a phase 1/2 interventional study registered as NCT03260023 by Transgene, with 143 participants enrolled, started 2017-09-01 and due to reach its primary completion in 2024-09-18. Interventions recorded: TG4001, Avelumab. Conditions listed: HPV-Related Carcinoma, HPV-Related Cervical Carcinoma, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Penile Squamous Cell Carcinoma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03260023","url":"https://clinicaltrials.gov/study/NCT03260023"}],"tags":["ctgov-ingest"],"related":[],"cancers":["penile","node-positive-penile-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["avelumab"],"companies":["transgene"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03260023","phase":"1/2","setting":"A Phase Ib/II Trial Evaluating the Combination of TG4001 and Avelumab in Patients With HPV-16 Positive Recurrent or Metastatic Malignancies.","sponsor":"Transgene","started":"2017-09-01","startedType":"actual","yearReported":2025,"enrolled":143,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1, Overall Response Rate","primary":true,"unit":"%","arms":[{"name":"Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab","n":30,"value":16.67,"note":"95% CI 5.64 to 34.72; Figures from the ClinicalTrials.gov results section (first posted 2025-12-02), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03260023?tab=results"},{"endpoint":"Phase II Part 2 Cohort A: Progression Free Survival (PFS) by RECIST 1.1","primary":true,"unit":"months","arms":[{"name":"Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab","n":46,"value":3,"note":"90% CI 2.0 to 4.4; Figures from the ClinicalTrials.gov results section (first posted 2025-12-02), not from a publication"},{"name":"Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab","n":44,"value":2.8,"note":"90% CI 1.7 to 4.2"}],"hr":0.87,"p":"0.2810","source":"https://clinicaltrials.gov/study/NCT03260023?tab=results"},{"endpoint":"Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification","primary":true,"unit":"months","arms":[{"name":"Phase II Part 2 - Cohort A - Cervix Cancer - TG4001 5x10e7 Pfu + Avelumab","n":25,"value":4.3,"note":"90% CI 1.7 to 12.7; Figures from the ClinicalTrials.gov results section (first posted 2025-12-02), not from a publication"},{"name":"Phase II Part 2 - Cohort A - Cervix Cancer - Avelumab","n":24,"value":2.1,"note":"90% CI 1.4 to 2.8"},{"name":"Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab","n":14,"value":3,"note":"90% CI 1.5 to 5.6"},{"name":"Phase II Part 2 - Cohort A - Anal Cancer - Avelumab","n":13,"value":3,"note":"90% CI 1.4 to NA"},{"name":"Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab","n":7,"value":1.6,"note":"90% CI 1.4 to 5.6"},{"name":"Phase II Part 2 - Cohort A - Genital Cancer - Avelumab","n":7,"value":7.2,"note":"90% CI 2.8 to NA"}],"source":"https://clinicaltrials.gov/study/NCT03260023?tab=results"}]},{"id":"nct07590934","kind":"trial","name":"Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer","aka":["PROSPECTOR"],"tldr":"A phase 1/2 trial of FPI-2265, Actinium-225 PSMA agents, Palacaparib in prostate cancer, run by AstraZeneca, now recruiting.","summary":"Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer is a phase 1/2 interventional study registered as NCT07590934 by AstraZeneca, with 152 participants planned, started 2026-06-03 and due to reach its primary completion in 2029-09-25. Interventions recorded: AZD2265 (FPI-2265), Palacaparib (AZD9574), Docetaxel, AZD2287 (Imaging agent). Conditions listed: Metastatic Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07590934","url":"https://clinicaltrials.gov/study/NCT07590934"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["fpi-2265","ac225-psma","palacaparib","docetaxel"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07590934","phase":"1/2","setting":"A Phase Ib/II, Open-label, Multi-centre, Platform Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Multiple Anti-Cancer Agents in Metastatic Prostate Cancer","sponsor":"AstraZeneca","started":"2026-06-03","startedType":"actual","enrolled":152,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05503888","kind":"trial","name":"Phase Ib/II Study of Almonertinib Combined With SHR-1701 in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of aumolertinib and retlirafusp alfa in lung cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., not yet recruiting.","summary":"Phase Ib/II Study of Almonertinib Combined With SHR-1701 in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer is a phase 1/2, randomised interventional study registered as NCT05503888 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with a registry enrolment figure of 160 participants, started 2022-10-01 and due to reach its primary completion in 2027-07-30. Interventions recorded: Almonertinib combined with SHR-1701; Almonertinib. Conditions listed: Relapsed or Advanced Non-small Cell Lung Cancer. Primary outcome: Dose limiting toxicity （Phase Ib）; The incidence and severity of ≥ grade 3 treatment-related adverse events (TRAE) and serious adverse events (TRSAE) in the combination of two drugs （Phase Ib）; PFS rate at 12 months. Lung eligibility wording from the registry: \"Advanced NSCLC diagnosed by histology or cytology, or recurrent NSCLC after radical treatment such as surgery, radiotherapy, chemoradiotherapy\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05503888","url":"https://clinicaltrials.gov/study/NCT05503888"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["aumolertinib","retlirafusp-alfa"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05503888","phase":"1/2","setting":"An Open-label, Multicenter Phase Ib/II Clinical Study of Almonertinib Combined With SHR-1701 or Other Innovative Drugs in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer With EGFR Mutation","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2022-10-01","startedType":"estimated","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07353268","kind":"trial","name":"Phase Ib/II Study of QL1706 + Fruquintinib + SCRT vs. Standard Third-Line Therapy in Unresectable Liver-Metastatic pMMR/MSS Colorectal Cancer: Safety, Tolerabil","aka":[],"tldr":"A phase 2 trial of QL1706 and fruquintinib in colorectal cancer, run by Tao Zhang, not yet recruiting.","summary":"Phase Ib/II Study of QL1706 + Fruquintinib + SCRT vs. Standard Third-Line Therapy in Unresectable Liver-Metastatic pMMR/MSS Colorectal Cancer: Safety, Tolerability, and Efficacy. is a phase 2, randomised interventional study registered as NCT07353268 by Tao Zhang, with a registry enrolment figure of 76 participants, started 2026-01-21 and due to reach its primary completion in 2027-08-31. Interventions recorded: QL1706 + Fruquintinib + Short-Course Ablative Radiotherapy (SCART); Standard Third-Line Therapy. Conditions listed: Colorectal Cancer. Primary outcome: Progression Free Survival（PFS）. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed metastatic colorectal cancer with unresectable liver metastasis(es) measuring ≥5 cm in the longest diameter\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07353268","url":"https://clinicaltrials.gov/study/NCT07353268"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","imrt-igrt","kinase-inhibitors"],"targets":[],"drugs":["ql1706","fruquintinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07353268","phase":"2","setting":"A Phase Ib/II Study Evaluating the Safety, Tolerability, and Efficacy of Epalolitovoreli Monoclonal Antibody (QL1706) and Fruquintinib Combined With Short-Course Radiotherapy (SCRT) Versus Standard Third-Line Therapy in Patients With Unresectable Liver-Metastatic pMMR/MSS Colorectal Cancer.","sponsor":"Tao Zhang","started":"2026-01-21","startedType":"estimated","enrolled":76,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07342725","kind":"trial","name":"Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Met","aka":[],"tldr":"A phase 1/2 trial of IBI363 in pancreatic cancer, run by Ruijin Hospital, not yet recruiting.","summary":"Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer is a phase 1/2, interventional study registered as NCT07342725 by Ruijin Hospital, with a registry enrolment figure of 48 participants, started 2026-01-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: IBI363 + chemotherapy. Conditions listed: Pancreatic Cancer Metastatic. Primary outcome: Adverse events (AEs); Progression-Free Survival(PFS). Pancreatic eligibility wording from the registry: \"* Histologically/cytologically confirmed, unresectable locally advanced or metastatic pancreatic cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07342725","url":"https://clinicaltrials.gov/study/NCT07342725"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["ibi363"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07342725","phase":"1/2","setting":"Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer","sponsor":"Ruijin Hospital","started":"2026-01-01","startedType":"estimated","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05024214","kind":"trial","name":"Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Lenvatinib, Envafolimab, Sunitinib in non-small-cell lung cancer and small-cell lung cancer, run by 3D Medicines (Sichuan) Co., Ltd., now recruiting.","summary":"Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors is a phase 1/2 interventional study registered as NCT05024214 by 3D Medicines (Sichuan) Co., Ltd., with 170 participants planned, started 2021-11-15 and due to reach its primary completion in 2026-12. Interventions recorded: Lenvatinib + Envafolimab, Sunitinib. Conditions listed: Solid Tumors, Non-small Cell Lung Cancer, Renal Cell Carcinoma, Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05024214","url":"https://clinicaltrials.gov/study/NCT05024214"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","rcc","hcc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["lenvatinib","envafolimab","sunitinib"],"companies":["3d-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05024214","phase":"1/2","setting":"Envafolimab(KN035) in Combination With Lenvatinib in the Treatment of Advanced Solid Tumors: a Multicenter, Open-label, Phase Ib/II Study","sponsor":"3D Medicines (Sichuan) Co., Ltd.","started":"2021-11-15","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05720130","kind":"trial","name":"Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).","aka":[],"tldr":"A phase 1/2 trial of [²¹²Pb]Pb-ADVC001 (Phase 1b) in prostate cancer, run by AdvanCell Pty Limited, now recruiting.","summary":"Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study). is a phase 1/2 interventional study registered as NCT05720130 by AdvanCell Pty Limited, with 100 participants planned, started 2023-03-15 and due to reach its primary completion in 2029-01-31. Interventions recorded: [²¹²Pb]Pb-ADVC001 (Phase 1b) and [²¹²Pb]Pb-ADVC001 (Phase 2a).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05720130","url":"https://clinicaltrials.gov/study/NCT05720130"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05720130","phase":"1/2","setting":"Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).","sponsor":"AdvanCell Pty Limited","started":"2023-03-15","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07243938","kind":"trial","name":"Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET)","aka":["UNION-HER2"],"tldr":"A phase 2 trial of zanidatamab, capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Tao Zhang, not yet recruiting.","summary":"Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET) is a phase 2, interventional study registered as NCT07243938 by Tao Zhang, with a registry enrolment figure of 70 participants, started 2026-01-15 and due to reach its primary completion in 2028-07-30. Interventions recorded: short-course radiotherapy; Zanidatamab; Tisleizumab(BGB-A317); Capecitabine; Oxaliplatin; TME surgery; S-1; D2. Conditions listed: Locally Advanced Rectal Cancer (LARC); Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma; Metastatic Colorectal Cancer (mCRC); Neoadjuvant Therapy. Primary outcome: Complete Response Rate (CR Rate); Pathological Complete Response Rate (pCR Rate); Progression-Free Survival (PFS). Colorectal eligibility wording from the registry: \"* Clinical diagnosis of gastric cancer and colorectal cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07243938","url":"https://clinicaltrials.gov/study/NCT07243938"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","her2-amplified-colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["zanidatamab","capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07243938","phase":"2","setting":"A Prospective, Multi-cohort Clinical Study to Explore the Preliminary Efficacy and Safety of Zanidatamab in Combination With Tislelizumab for HER2-Positive GI Tumors: the UNION-HER2-BASKET Study","sponsor":"Tao Zhang","started":"2026-01-15","startedType":"estimated","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06852287","kind":"trial","name":"Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer","aka":["GOLD-HAIC"],"tldr":"A phase 2 trial of toripalimab, gemcitabine, oxaliplatin and lenvatinib in gallbladder cancer and other biliary tract cancers, run by Tianjin Medical University Cancer Institute and Hospital, now recruiting.","summary":"Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer is a phase 2 interventional study registered as NCT06852287 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 33 participants, started 2024-09-01 and due to reach its primary completion in 2026-09-01. Interventions recorded: chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.. Conditions listed: Intrahepatic Cholangiocarcinoma (Icc), Gall Bladder Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06852287","url":"https://clinicaltrials.gov/study/NCT06852287"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","kinase-inhibitors"],"targets":[],"drugs":["toripalimab","gemcitabine","oxaliplatin","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06852287","phase":"2","setting":"Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2024-09-01","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06413745","kind":"trial","name":"Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of Trastuzumab rezetecan in biliary tract cancer, run by Jiangsu HengRui Medicine Co., Ltd., active and no longer recruiting.","summary":"Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer is a phase 2 interventional study registered as NCT06413745 by Jiangsu HengRui Medicine Co., Ltd., with 59 participants enrolled, started 2024-06-04 and due to reach its primary completion in 2026-12-31. Interventions recorded: SHR-A1811.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06413745","url":"https://clinicaltrials.gov/study/NCT06413745"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06413745","phase":"2","setting":"A Phase II Clinical Study of SHR-A1811 in Patients With HER2-expressing/Amplified, Locally Advanced, Unresectable or Metastatic Biliary Tract Cancer (BTC) Who Have Previously Failed First or Second-line Systemic Therapy","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2024-06-04","startedType":"actual","enrolled":59,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07175220","kind":"trial","name":"Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects","aka":[],"tldr":"A phase 2 trial of SHR-A2102, Retlirafusp alfa in non-small-cell lung cancer and small-cell lung cancer, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects is a phase 2 interventional study registered as NCT07175220 by Jiangsu HengRui Medicine Co., Ltd., with 200 participants planned, started 2025-10-09 and due to reach its primary completion in 2028-10. Interventions recorded: SHR2554; SHR-A2102, SHR2554; Adabelimumab, SHR2554; SHR-1701. Conditions listed: Locally Advanced or Metastatic Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07175220","url":"https://clinicaltrials.gov/study/NCT07175220"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-a2102","retlirafusp-alfa"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07175220","phase":"2","setting":"A Multicenter, Open Label Phase II Clinical Study on the Safety, Tolerability, and Efficacy of SHR2554 Tablets in Combination With Other Anti-tumor Treatments in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-10-09","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06708858","kind":"trial","name":"Phase Ⅱ Clinical Study of Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of durvalumab, pembrolizumab, gemcitabine and other drugs in gallbladder cancer and other biliary tract cancers, run by Dai, Guanghai, now recruiting.","summary":"Phase Ⅱ Clinical Study of Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT06708858 by Dai, Guanghai, with a registry enrolment figure of 35 participants, started 2024-08-15 and due to reach its primary completion in 2025-12. Interventions recorded: Surufatinib, Gemcitabine, Cisplatin, Durvalumab, Pembrolizumab. Conditions listed: Advanced Biliary Tract Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06708858","url":"https://clinicaltrials.gov/study/NCT06708858"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","kinase-inhibitors"],"targets":[],"drugs":["durvalumab","pembrolizumab","gemcitabine","cisplatin","surufatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06708858","phase":"2","setting":"Phase Ⅱ Clinical Study of Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer","sponsor":"Dai, Guanghai","started":"2024-08-15","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05239650","kind":"trial","name":"Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC","aka":[],"tldr":"A phase 2 trial of serplulimab and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Shanghai Henlius Biotech, not yet recruiting.","summary":"Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC is a phase 2, interventional study registered as NCT05239650 by Shanghai Henlius Biotech, with a registry enrolment figure of 50 participants, started 2022-07-15 and due to reach its primary completion in 2025-10-15. Interventions recorded: HLX07; HLX10; mFOLFOX6. Conditions listed: CRC. Primary outcome: ORR; PFS. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05239650","url":"https://clinicaltrials.gov/study/NCT05239650"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["serplulimab","folfox"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05239650","phase":"2","setting":"An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients With Metastatic Colorectal Cancer","sponsor":"Shanghai Henlius Biotech","started":"2022-07-15","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07742956","kind":"trial","name":"Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK201 for Injection in Combination With Ivonescimab In","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Shanghai Allink Biotherapeutics Co., Ltd., not yet recruiting.","summary":"Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK201 for Injection in Combination With Ivonescimab Injection in sqNSCLC Participants. is a phase 2, randomised interventional study registered as NCT07742956 by Shanghai Allink Biotherapeutics Co., Ltd., with a registry enrolment figure of 156 participants, started 2026-08-20 and due to reach its primary completion in 2027-12-31. Interventions recorded: ALK201 for injection; Ivonescimab Injection. Conditions listed: NSCLC (Advanced Non-small Cell Lung Cancer). Primary outcome: TEAEs. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07742956","url":"https://clinicaltrials.gov/study/NCT07742956"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-squamous-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07742956","phase":"2","setting":"An Open-label, Multicenter Phase II Clinical Trial to Evaluate ALK201 for Injection Combined With Ivonescimab Injection in Subjects With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer","sponsor":"Shanghai Allink Biotherapeutics Co., Ltd.","started":"2026-08-20","startedType":"estimated","enrolled":156,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07603791","kind":"trial","name":"Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Drugs in NSCLC","aka":[],"tldr":"A phase 2 trial of carboplatin in lung cancer, run by Shanghai Allink Biotherapeutics Co., Ltd., not yet recruiting.","summary":"Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Drugs in NSCLC Participants. is a phase 2, randomised interventional study registered as NCT07603791 by Shanghai Allink Biotherapeutics Co., Ltd., with a registry enrolment figure of 252 participants, started 2026-06-30 and due to reach its primary completion in 2027-12-30. Interventions recorded: ALK202 for injection; Osimertinib Mesylate Tablets; Ivonescimab Injection; carboplatin injection. Conditions listed: NSCLC (Advanced Non-small Cell Lung Cancer). Primary outcome: TEAEs. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07603791","url":"https://clinicaltrials.gov/study/NCT07603791"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07603791","phase":"2","setting":"An Open, Multicenter Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Different Drugs in NSCLC Participants.","sponsor":"Shanghai Allink Biotherapeutics Co., Ltd.","started":"2026-06-30","startedType":"estimated","enrolled":252,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07003022","kind":"trial","name":"Phase II Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC","aka":[],"tldr":"A phase 2 trial of cadonilimab in colorectal cancer, run by Fudan University, now recruiting.","summary":"Phase II Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC is a phase 2, interventional study registered as NCT07003022 by Fudan University, with a registry enrolment figure of 40 participants, started 2025-06-01 and due to reach its primary completion in 2027-05-01. Interventions recorded: cadonilimab combined with an anti-angiogenic agent, which is selected by the investigator from bevacizumab, regorafenib, or fruquintinib.. Conditions listed: Colo-rectal Cancer; MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers. Primary outcome: Objective Response Rate (ORR). Colorectal eligibility wording from the registry: \"dMMR or MSI-H Diagnosis confirmed by histological examination and/or cytological examination combined with imaging assessment of advanced colorectal cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07003022","url":"https://clinicaltrials.gov/study/NCT07003022"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cadonilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07003022","phase":"2","setting":"An Open and Exploratory Phase II Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H Colorectal Cancer","sponsor":"Fudan University","started":"2025-06-01","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04586478","kind":"trial","name":"Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma","aka":[],"tldr":"A phase 2 trial of single dose of CNCT19 in non-Hodgkin lymphoma, run by Juventas Cell Therapy Ltd., now recruiting.","summary":"Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma is a phase 2 interventional study registered as NCT04586478 by Juventas Cell Therapy Ltd., with 60 participants planned, started 2020-10-26 and due to reach its primary completion in 2024-03-30. Interventions recorded: single dose of CNCT19.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04586478","url":"https://clinicaltrials.gov/study/NCT04586478"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["inaticabtagene-autoleucel"],"companies":["juventas-cell-therapy"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04586478","phase":"2","setting":"Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma","sponsor":"Juventas Cell Therapy Ltd.","started":"2020-10-26","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06771609","kind":"trial","name":"Phase II Clinical Trial of PD-L1 in Combination With Vinorelbine + Cyclophosphamide + Capecitabine (VEX) Metronomic Chemotherapy With or Without Radiotherapy fo","aka":[],"tldr":"A phase 2 trial of adebrelimab in triple-negative breast cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"Phase II Clinical Trial of PD-L1 in Combination With Vinorelbine + Cyclophosphamide + Capecitabine (VEX) Metronomic Chemotherapy With or Without Radiotherapy for Advanced Triple-negative Breast Cancer. is a phase 2, randomised interventional study registered as NCT06771609 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 150 participants, started 2024-09-10 and due to reach its primary completion in 2028-09-10. Interventions recorded: Adebrelimab + VEX metronomic chemotherapy + radiotherapy; Adebrelimab + VEX metronomic chemotherapy. Conditions listed: Advanced Triple-negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Subjects with metastatic triple-negative breast cancer, with clear clinical data records; specific reference to the \"American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06771609","url":"https://clinicaltrials.gov/study/NCT06771609"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06771609","phase":"2","setting":"Evaluate the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy With or Without Radiotherapy in Advanced Triple-negative Breast Cancer: a Prospective, Multicenter, Randomized Controlled Phase II Clinical Trial.","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2024-09-10","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05739981","kind":"trial","name":"Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer","aka":[],"tldr":"A phase 1/2 trial of Paclitaxel / nab-paclitaxel, Carboplatin, Bevacizumab in ovarian cancer, run by Imunon, now recruiting.","summary":"Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer is a phase 1/2 interventional study registered as NCT05739981 by Imunon, with 30 participants planned, started 2023-02-10 and due to reach its primary completion in 2027-06-30. Interventions recorded: Paclitaxel, Carboplatin, Bevacizumab, IMNN-001. Conditions listed: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05739981","url":"https://clinicaltrials.gov/study/NCT05739981"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["paclitaxel","carboplatin","bevacizumab"],"companies":["imunon"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05739981","phase":"1/2","setting":"Phase II Study Evaluating the Effect of IMNN-001 on Second Look Laparoscopy (SLL) in Combination With Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in Newly Diagnosed With Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer","sponsor":"Imunon","started":"2023-02-10","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05870800","kind":"trial","name":"Phase II Open-label Trial of Neoadjuvant Immunochemotherapy for Resectable Non-metastatic Colon cancER: NICER","aka":["NICER"],"tldr":"A phase 2 trial in colorectal cancer, run by Baylor College of Medicine, now recruiting.","summary":"Phase II Open-label Trial of Neoadjuvant Immunochemotherapy for Resectable Non-metastatic Colon cancER: NICER is a phase 2, interventional study registered as NCT05870800 by Baylor College of Medicine, with a registry enrolment figure of 28 participants, started 2025-06-15 and due to reach its primary completion in 2026-09-01. Interventions recorded: Tecentriq 1200 MG in 20 ML Injection + Capecitabine 1000 mg/m2 + Oxaliplatin 130 mg/m2; Oxaliplatin injection 85mg/m2 + Leucovorin 400mg/m2 + 5-Fluorouracil 2400mg/m2; Oxaliplatin 130mg/m2 + Capecitabine 1000mg/m2. Conditions listed: Stage I Colon Cancer; Stage II Colon Cancer; Stage III Colon Cancer. Primary outcome: Determine the rate of tumor regression grade 1 (<10% viable cancer cells) to neoadjuvant immunotherapy and chemotherapy in resectable (non-metastatic) pMMR colon cancer, assessed in the resection specimen.. Colorectal eligibility wording from the registry: \"* Histologically or cytologically confirmed resectable non-metastatic adenocarcinoma of the colon\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05870800","url":"https://clinicaltrials.gov/study/NCT05870800"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05870800","phase":"2","setting":"Phase II Open-label Trial of Neoadjuvant Immunotherapy (Atezolizumab) in Combination With CAPOX for Resectable Non-metastatic Proficient Mismatch Repair (pMMR) Colon CancER: NICER Study","sponsor":"Baylor College of Medicine","started":"2025-06-15","startedType":"estimated","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07154316","kind":"trial","name":"Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of cAPOX (capecitabine, oxaliplatin) and celecoxib in colorectal cancer, run by Fudan University, now recruiting.","summary":"Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT07154316 by Fudan University, with a registry enrolment figure of 138 participants, started 2025-08-01 and due to reach its primary completion in 2028-08-01. Interventions recorded: LCRT; SCRT; CAPOX; PD-1; Celecoxib. Conditions listed: Colorectal Cancer. Primary outcome: CR (Complete Response). Colorectal eligibility wording from the registry: \"* Pathologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07154316","url":"https://clinicaltrials.gov/study/NCT07154316"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capox","celecoxib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07154316","phase":"2","setting":"A Randomized Phase II Study of Long-term Chemoradiotherapy or Short-term Radiotherapy Combined With CAPOX, PD-1 Monoclonal Antibody and COX-2 Inhibitors in MSS Type Locally Advanced Rectal Cancer","sponsor":"Fudan University","started":"2025-08-01","startedType":"actual","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00539591","kind":"trial","name":"Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma","aka":[],"tldr":"A phase 2 trial of Peginterferon alfa-2b and Temozolomide in Melanoma, run by St. Jude Children's Research Hospital, active and no longer recruiting.","summary":"Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma is a phase 2 interventional study registered as NCT00539591 by St. Jude Children's Research Hospital, with 29 participants planned, started 2008-05-09 and due to reach its primary completion in 2015-06. Interventions recorded: Peginterferon alfa-2b, Temozolomide, Recombinant interferon alfa-2b. Conditions recorded: Malignant Melanoma.\n\nLinked to the drug Peginterferon alfa-2b because the registry names it among its interventions and Melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00539591","url":"https://clinicaltrials.gov/study/NCT00539591"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["peginterferon-alfa-2b","temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00539591","phase":"2","setting":"Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma","sponsor":"St. Jude Children's Research Hospital","started":"2008-05-09","startedType":"actual","yearReported":2014,"enrolled":29,"enrolledBasis":"registry","outcomes":[{"endpoint":"Probability of Event-free Survival (EFS) of Stratum A Participants","primary":true,"unit":"probability","arms":[{"name":"Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b","n":23,"value":0.913,"note":"95% CI 0.79 to 1.00; Figures from the ClinicalTrials.gov results section (first posted 2014-02-27), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00539591?tab=results"}]},{"id":"nct05195632","kind":"trial","name":"Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung","aka":["OCEANII"],"tldr":"A phase 2 trial of Encorafenib, Binimetinib in non-small-cell lung cancer and small-cell lung cancer, run by Pierre Fabre Medicament, active and no longer recruiting.","summary":"Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT05195632 by Pierre Fabre Medicament, with 63 participants enrolled, started 2022-06-02 and due to reach its primary completion in 2024-05-27. Interventions recorded: Encorafenib, Binimetinib. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05195632","url":"https://clinicaltrials.gov/study/NCT05195632"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","braf-v600e-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["encorafenib","binimetinib"],"companies":["pierre-fabre"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05195632-lung-cancer-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05195632","phase":"2","setting":"Multicenter, Open-label, Phase II Study With a Safety Lead-in Part Investigating the Efficacy, Safety and Pharmacokinetics of Encorafenib and Binimetinib Combination in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer Who Are BRAF- and MEK Inhibitor Treatment-naïve","sponsor":"Pierre Fabre Medicament","started":"2022-06-02","startedType":"actual","enrolled":63,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06959550","kind":"trial","name":"Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of ivonescimab in colorectal cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06959550 by M.D. Anderson Cancer Center, with a registry enrolment figure of 90 participants, started 2025-07-28 and due to reach its primary completion in 2028-07-01. Interventions recorded: Ivonescimab. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: 1. Safety and Adverse Events (AEs). Colorectal eligibility wording from the registry: \"Histological or cytological confirmed advanced, metastatic adenocarcinoma of colon or rectum\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06959550","url":"https://clinicaltrials.gov/study/NCT06959550"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab"],"companies":["summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06959550","phase":"2","setting":"Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer","sponsor":"M.D. Anderson Cancer Center","started":"2025-07-28","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06075264","kind":"trial","name":"Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)","aka":[],"tldr":"A phase 2 trial of Artesunate ointment in vulvar cancer, run by Frantz Viral Therapeutics, LLC, now recruiting.","summary":"Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3) is a phase 2 interventional study registered as NCT06075264 by Frantz Viral Therapeutics, LLC, with 27 participants planned, started 2023-12-06 and due to reach its primary completion in 2026-12. Interventions recorded: Artesunate ointment and Placebo ointment.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06075264","url":"https://clinicaltrials.gov/study/NCT06075264"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["vulvar","hpv-associated-vulvar-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["frantz-viral-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06075264","phase":"2","setting":"A Phase II Double-blind, Placebo-controlled, Randomized Trial of Topical Artesunate Ointment for the Treatment of Patients With Vulvar High-grade Squamous Intraepithelial Lesions (Vulvar HSIL)","sponsor":"Frantz Viral Therapeutics, LLC","started":"2023-12-06","startedType":"actual","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00004688","kind":"trial","name":"Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms","aka":[],"tldr":"A phase 2 trial of Carmustine, Mercaptopurine and Streptozocin in Oligodendroglioma, IDH-mutant and 1p/19q-codeleted and Glioma & glioblastoma, run by Emory University, completed.","summary":"Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms is a phase 2 interventional study registered as NCT00004688 by Emory University, with 35 participants recorded, started 1996-08. Interventions recorded: carmustine, mercaptopurine, streptozocin. Conditions recorded: Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Mixed Gliomas, Glioblastoma Multiforme, Recurrent Brain Tumor.\n\nLinked to the drug Streptozocin because the registry names it among its interventions and Oligodendroglioma, IDH-mutant and 1p/19q-codeleted and Glioma & glioblastoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00004688","url":"https://clinicaltrials.gov/study/NCT00004688"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["oligodendroglioma","glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":["carmustine","mercaptopurine","streptozocin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00004688","phase":"2","setting":"Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms","sponsor":"Emory University","started":"1996-08","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05866432","kind":"trial","name":"Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases","aka":["TUXEDO-2"],"tldr":"A phase 2 trial of datopotamab deruxtecan in triple-negative breast cancer, run by Medical University of Vienna, now recruiting.","summary":"Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases is a phase 2, interventional study registered as NCT05866432 by Medical University of Vienna, with a registry enrolment figure of 20 participants, started 2023-07-01 and due to reach its primary completion in 2026-05-23. Interventions recorded: Datopotamab deruxtecan. Conditions listed: Breast Cancer Stage IV. Triple-negative eligibility wording from the registry: \"* Triple-negative disease as defined by immunohistochemistry (IHC) and/or c-erb-B2 gene amplification status\". Sites: Austria. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05866432","url":"https://clinicaltrials.gov/study/NCT05866432"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","brain-metastases"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["datopotamab-deruxtecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05866432","phase":"2","setting":"Phase II Study of Datopotamab-Deruxtecan (Dato-DXd; DS-1026a) in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases","sponsor":"Medical University of Vienna","started":"2023-07-01","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07572396","kind":"trial","name":"Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities","aka":[],"tldr":"A phase 2 trial of EGCG and Quinine Sulfate Vaginal Suppository in vaginal cancer, run by Amplexd Therapeutics, Inc., now recruiting.","summary":"Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities is a phase 2 interventional study registered as NCT07572396 by Amplexd Therapeutics, Inc., with 45 participants planned, started 2026-04-30 and due to reach its primary completion in 2026-12-27. Interventions recorded: EGCG and Quinine Sulfate Vaginal Suppository.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07572396","url":"https://clinicaltrials.gov/study/NCT07572396"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["vaginal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07572396","phase":"2","setting":"A Phase II, Randomized, Double-blind, Placebo-Controlled, Proof of Concept Study to Assess the Safety and Efficacy of Dysplasix™ Intravaginally-Administered Suppositories in Patients With High-Risk Human Papillomavirus (Hr-HPV) as Determined by HPV Testing, and Accompanied by Either (1) Atypical Squamous Cells of Undetermined Significance (ASC-US) or (2) Low-Grade Squamous Intraepithelial Lesions (LSIL), as Determined by Cytology","sponsor":"Amplexd Therapeutics, Inc.","started":"2026-04-30","startedType":"estimated","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07314294","kind":"trial","name":"Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients","aka":[],"tldr":"A phase 2 trial of EMB-01 1600 mg administered once weekly throughout the study in colorectal cancer, run by Shanghai EpimAb Biotherapeutics Co., Ltd., now recruiting.","summary":"Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients is a phase 2 interventional study registered as NCT07314294 by Shanghai EpimAb Biotherapeutics Co., Ltd., with 54 participants planned, started 2025-12-18 and due to reach its primary completion in 2027-12-30. Interventions recorded: EMB-01 1600 mg administered once weekly throughout the study and EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafter.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07314294","url":"https://clinicaltrials.gov/study/NCT07314294"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07314294","phase":"2","setting":"A Randomized, Open-label, Phase II Study of EMB-01 in Patients With Recurrent/Metastatic Colorectal Cancer","sponsor":"Shanghai EpimAb Biotherapeutics Co., Ltd.","started":"2025-12-18","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00582075","kind":"trial","name":"Phase II Study of Gamma Knife Radiosurgery and Temozolomide for Brain Metastases","aka":[],"tldr":"A phase 2 trial of Gamma Knife in Brain metastases, run by University of Alabama at Birmingham, completed.","summary":"Phase II Study of Gamma Knife Radiosurgery and Temozolomide for Brain Metastases is a phase 2 interventional study registered as NCT00582075 by University of Alabama at Birmingham, with 25 participants recorded, started 2002-07 and reaching its primary completion in 2008-10. Interventions recorded: temozolomide. Conditions recorded: Cancer, Brain Metastases.\n\nLinked to the technology Gamma Knife because the registry's title names it (\"gamma knife\") and Brain metastases among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00582075","url":"https://clinicaltrials.gov/study/NCT00582075"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["secondary-brain-tumours"],"sections":[],"technologies":["gamma-knife"],"targets":[],"drugs":["temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00582075","phase":"2","setting":"Phase II Study of Gamma Knife Radiosurgery and Temozolomide (Temodar) for Newly Diagnosed Brain Metastases","sponsor":"University of Alabama at Birmingham","started":"2002-07","yearReported":2015,"enrolled":25,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Distant Brain Failure (DBF) at One Year","primary":true,"unit":"%","arms":[{"name":"Radiosurgery 15-24 Gy + Adjuvant Temozolomide","n":25,"value":37,"note":"Figures from the ClinicalTrials.gov results section (first posted 2015-09-17), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00582075?tab=results"},{"endpoint":"Overall Survival","unit":"weeks","arms":[{"name":"Radiosurgery 15-24 Gy + Adjuvant Temozolomide","n":25,"value":31,"note":"range 11 to 104; Figures from the ClinicalTrials.gov results section (first posted 2015-09-17), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00582075?tab=results"}]},{"id":"nct07487519","kind":"trial","name":"Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Br","aka":[],"tldr":"A phase 2 trial of serplulimab in triple-negative breast cancer, run by Shanghai Henlius Biotech, not yet recruiting.","summary":"Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer. is a phase 2, randomised interventional study registered as NCT07487519 by Shanghai Henlius Biotech, with a registry enrolment figure of 180 participants, started 2026-04-25 and due to reach its primary completion in 2027-05-15. Interventions recorded: HLX43 DOSE 1 IN ≥2L TNBC; HLX43 DOSE 2 IN ≥2L TNBC; HLX43 DOSE 1 + HLX10; HLX43 DOSE1 IN 1L TNBC; HLX43 DOSE 2 IN 1L TNBC; HLX43 DOSE2 + HLX10. Conditions listed: Breast Cancer (Triple Negative Breast Cancer (TNBC)). Triple-negative eligibility wording from the registry: \"Histopathologically confirmed TNBC: ER \\< 1%, PR \\< 1%, HER2 IHC 0/1+/2+ with no FISH amplification\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07487519","url":"https://clinicaltrials.gov/study/NCT07487519"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["serplulimab"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07487519","phase":"2","setting":"A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) as a Monotherapy or in Combination With Immune Checkpoint Inhibitors in Subjects With Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (TNBC).","sponsor":"Shanghai Henlius Biotech","started":"2026-04-25","startedType":"estimated","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07530445","kind":"trial","name":"Phase II Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Albumin-Bound Paclitaxel and Lenvatinib as Second-Line Therapy for Unresectable or Metastatic Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of nab-paclitaxel and lenvatinib in gallbladder cancer and other biliary tract cancers, run by Sun Yat-sen University, now recruiting.","summary":"Phase II Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Albumin-Bound Paclitaxel and Lenvatinib as Second-Line Therapy for Unresectable or Metastatic Biliary Tract Cancer is a phase 2 interventional study registered as NCT07530445 by Sun Yat-sen University, with a registry enrolment figure of 40 participants, started 2026-03-23 and due to reach its primary completion in 2027-04-30. Interventions recorded: Drug: QL1706 5mg/kg, iv drip,d1,Q3W; Albumin-Bound Paclitaxel 125mg/m2, iv drip, d1、d8, Q3W; Lenvatinib 8mg, po, QD. Conditions listed: Second-Line Therapy for Unresectable or Metastatic Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: \"2. Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary-tract cancer (gallbladder carcinoma, cholangiocarcinoma, or ampullary carcinoma of pancreaticobiliary type).\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07530445","url":"https://clinicaltrials.gov/study/NCT07530445"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["nab-paclitaxel","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07530445","phase":"2","setting":"A Single-Center, Single-Arm, Open-Label Phase II Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Albumin-Bound Paclitaxel and Lenvatinib as Second-Line Therapy for Unresectable or Metastatic Biliary Tract Cancer","sponsor":"Sun Yat-sen University","started":"2026-03-23","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06341296","kind":"trial","name":"Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of fluorouracil (5-FU), leucovorin (folinic acid) and bevacizumab (glioblastoma use) in colorectal cancer, run by West China Hospital, now recruiting.","summary":"Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06341296 by West China Hospital, with a registry enrolment figure of 86 participants, started 2024-06-30 and due to reach its primary completion in 2026-04. Interventions recorded: Irinotecan Liposome; 5-FU; LV; Bevacizumab. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Objective response rate. Colorectal eligibility wording from the registry: \"* Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06341296","url":"https://clinicaltrials.gov/study/NCT06341296"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","leucovorin","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06341296","phase":"2","setting":"Phase II Study of Irinotecan Liposomes Combined With 5-FU/LV+ Bevacizumab in First-line Treatment of Metastatic Colorectal Cancer","sponsor":"West China Hospital","started":"2024-06-30","startedType":"actual","enrolled":86,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01772420","kind":"trial","name":"Phase II Study of Lenalidomide and Eltrombopag in Patients With Symptomatic Anemia","aka":[],"tldr":"A phase 2 trial of Eltrombopag and Lenalidomide in Leukaemia, run by Albert Einstein College of Medicine, completed.","summary":"Phase II Study of Lenalidomide and Eltrombopag in Patients With Symptomatic Anemia is a phase 2 interventional study registered as NCT01772420 by Albert Einstein College of Medicine, with 52 participants recorded, started 2012-10 and reaching its primary completion in 2020-07-09. Interventions recorded: Eltrombopag Olamine, Laboratory Biomarker Analysis, Lenalidomide. Conditions recorded: Adult Myelodysplastic Syndrome, Anemia, Chronic Myelomonocytic Leukemia.\n\nLinked to the drug Eltrombopag because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01772420","url":"https://clinicaltrials.gov/study/NCT01772420"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["eltrombopag","lenalidomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01772420","phase":"2","setting":"Phase II Study of Lenalidomide and Eltrombopag in Patients With Symptomatic Anemia in Low or Intermediate I Myelodysplastic Syndrome (MDS)","sponsor":"Albert Einstein College of Medicine","started":"2012-10","yearReported":2023,"enrolled":52,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Patients Demonstrating Overall Hematologic Improvement (HI)","primary":true,"unit":"participants","arms":[{"name":"Arm A (Platelets > 50,000 k/uL) LEN Initiation","n":16,"value":6,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-07-27), not from a publication"},{"name":"Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination","n":15,"value":5},{"name":"Arm C (Platelets < 50,000 k/uL) ELT Monotherapy","n":21,"value":7}],"source":"https://clinicaltrials.gov/study/NCT01772420?tab=results"}]},{"id":"nct07387081","kind":"trial","name":"Phase II Study of LM-24C5","aka":[],"tldr":"A phase 2 trial of LM-24C5 in advanced solid tumours, run by LaNova Medicines Limited, now recruiting.","summary":"Phase II Study of LM-24C5 is a phase 2 interventional study registered as NCT07387081 by LaNova Medicines Limited, with 130 participants planned, started 2025-12-15 and due to reach its primary completion in 2028-05-21. Interventions recorded: LM-24C5.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07387081","url":"https://clinicaltrials.gov/study/NCT07387081"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["lanova-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07387081","phase":"2","setting":"An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of LM-24C5 in Combination With Other Anti-tumor Treatment in Subjects With CEACAM5-positive Advanced Solid Tumors","sponsor":"LaNova Medicines Limited","started":"2025-12-15","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06830239","kind":"trial","name":"Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer","aka":["Superhero"],"tldr":"A phase 2 trial of dostarlimab in colorectal cancer, run by Universitaire Ziekenhuizen KU Leuven, now recruiting.","summary":"Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer is a phase 2, interventional study registered as NCT06830239 by Universitaire Ziekenhuizen KU Leuven, with a registry enrolment figure of 10 participants, started 2025-04-03 and due to reach its primary completion in 2027-12. Interventions recorded: Dostarlimab. Conditions listed: Colon Cancer Stage III. Primary outcome: Multi-omic exploration. Colorectal eligibility wording from the registry: \"* primary adenocarcinoma colon cancer than can be removed surgically, staged cT3-4, cN0-2, cM0 or stage III\". Sites: Belgium. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06830239","url":"https://clinicaltrials.gov/study/NCT06830239"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06830239","phase":"2","setting":"Early Phase II Exploratory, Open-Label, Non-Randomized Study of Neoadjuvant Dostarlimab Monotherapy in Participants With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer","sponsor":"Universitaire Ziekenhuizen KU Leuven","started":"2025-04-03","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00742027","kind":"trial","name":"Phase II Study of Oral Panobinostat in Adult Participants With Relapsed/Refractory Classical Hodgkin's Lymphoma","aka":[],"tldr":"A phase 2 trial of Panobinostat in Hodgkin lymphoma, run by Novartis Pharmaceuticals, completed.","summary":"Phase II Study of Oral Panobinostat in Adult Participants With Relapsed/Refractory Classical Hodgkin's Lymphoma is a phase 2 interventional study registered as NCT00742027 by Novartis Pharmaceuticals, with 129 participants recorded, started 2008-09-16 and reaching its primary completion in 2013-08-12. Interventions recorded: Panobinostat. Conditions recorded: Classical Hodgkin's Lymphoma.\n\nLinked to the drug Panobinostat because the registry names it among its interventions and Hodgkin lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00742027","url":"https://clinicaltrials.gov/study/NCT00742027"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","relapsed-refractory-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["panobinostat"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00742027","phase":"2","setting":"A Phase II Study of Oral Panobinostat in Adult Patients With Relapsed/Refractory Classical Hodgkins Lymphoma After High-dose Chemotherapy With Autologous Stem Cell Transplant","sponsor":"Novartis Pharmaceuticals","started":"2008-09-16","startedType":"actual","yearReported":2021,"enrolled":129,"enrolledBasis":"registry","outcomes":[{"endpoint":"The Overall Survival (OS)","unit":"months","arms":[{"name":"Panobinostat","n":129,"value":34.9,"note":"range 0.7 to 53; Figures from the ClinicalTrials.gov results section (first posted 2021-06-03), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00742027?tab=results"},{"endpoint":"Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Panobinostat","n":129,"value":6.1,"note":"95% CI 5.4 to 8.3; Figures from the ClinicalTrials.gov results section (first posted 2021-06-03), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00742027?tab=results"}]},{"id":"nct07057791","kind":"trial","name":"Phase II Study of Platinum/Etoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer","aka":["PrE0510"],"tldr":"A phase 2 trial in lung cancer, run by PrECOG, LLC., now recruiting.","summary":"Phase II Study of Platinum/Etoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer is a phase 2, randomised interventional study registered as NCT07057791 by PrECOG, LLC., with a registry enrolment figure of 60 participants, started 2026-03-30 and due to reach its primary completion in 2027-12. Interventions recorded: Ivonescimab 10 mg/kg; Ivonescimab 20 mg/kg. Conditions listed: Extensive Stage Lung Small Cell Cancer. Primary outcome: Optimal Dose of Ivonescimab in Combination with Carboplatin and Etoposide - Overall Response Rate (ORR); Optimal Dose of Ivonescimab in Combination with Carboplatin and Etoposide - Grade 3-5 Treatment-Related Toxicity Rate. Lung eligibility wording from the registry: \"* Patients must have pathologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07057791","url":"https://clinicaltrials.gov/study/NCT07057791"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07057791","phase":"2","setting":"Phase II Dose Optimization Study of Platinum/Etoposide Plus Ivonescimab (CEI) as First-Line Treatment of Extensive-Stage Small Cell Lung Cancer","sponsor":"PrECOG, LLC.","started":"2026-03-30","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07724756","kind":"trial","name":"Phase II Study of QLC2519 in Pediatric Solid Tumor Participants","aka":[],"tldr":"A phase 2 trial of Albipagrastim alf in childhood cancers, run by Qilu Pharmaceutical Co., Ltd., now recruiting.","summary":"Phase II Study of QLC2519 in Pediatric Solid Tumor Participants is a phase 2 interventional study registered as NCT07724756 by Qilu Pharmaceutical Co., Ltd., with 18 participants planned, started 2026-06-26 and due to reach its primary completion in 2027-06-26. Interventions recorded: Albipagrastim alf.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07724756","url":"https://clinicaltrials.gov/study/NCT07724756"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["childhood-cancers"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07724756","phase":"2","setting":"A Multicenter, Open-label Phase II Clinical Study Evaluating the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Albipagrastim Alfa for Injection (QLC2519) in Pediatric Solid Tumor Participants","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2026-06-26","startedType":"estimated","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07018050","kind":"trial","name":"Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma","aka":[],"tldr":"A phase 2 trial of QLS32015, Pomalidomide, Dexamethasone in multiple myeloma, run by Qilu Pharmaceutical Co., Ltd., now recruiting.","summary":"Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma is a phase 2 interventional study registered as NCT07018050 by Qilu Pharmaceutical Co., Ltd., with 160 participants planned, started 2025-09-12 and due to reach its primary completion in 2027-11. Interventions recorded: QLS32015, Pomalidomide, Dexamethasone, QL2109 or Daratumumab, Bortezomib. Conditions listed: Relapsed or Refractory Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07018050","url":"https://clinicaltrials.gov/study/NCT07018050"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["qls32015","pomalidomide","dexamethasone","bortezomib","lenalidomide"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07018050","phase":"2","setting":"A Multicenter, Open-Label Phase II Study to Evaluate QLS32015 Combination Therapy in the Treatment of Multiple Myeloma","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2025-09-12","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07329322","kind":"trial","name":"Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Facto","aka":[],"tldr":"A phase 2 trial of Sacituzumab tirumotecan, Osimertinib in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT07329322 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 30 participants planned, started 2026-03-30 and due to reach its primary completion in 2027-08-31. Interventions recorded: Sacituzumab Tirumotecan, Osimertinib. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07329322","url":"https://clinicaltrials.gov/study/NCT07329322"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["adc","kinase-inhibitors","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","osimertinib"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07329322","phase":"2","setting":"A Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-03-30","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06521866","kind":"trial","name":"Phase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of serplulimab in colorectal cancer, run by Fudan University, now recruiting.","summary":"Phase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal Cancer is a phase 2, randomised interventional study registered as NCT06521866 by Fudan University, with a registry enrolment figure of 208 participants, started 2025-03-01 and due to reach its primary completion in 2026-08-01. Interventions recorded: Serplulimab; Chemotherapy; SABR; Targeted therapy. Conditions listed: Advanced Colorectal Carcinoma; Immunotherapy. Primary outcome: PFS. Colorectal eligibility wording from the registry: \"Histologically confirmed metastatic colorectal cancer (Stage IV, UICC), with initially unresectable metastases or refusal of surgery;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06521866","url":"https://clinicaltrials.gov/study/NCT06521866"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","sbrt"],"targets":[],"drugs":["serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06521866","phase":"2","setting":"A Prospective, Randomized, Phase II, Multicenter Clinical Study of Serplulimab Combined with First-Line Targeted Therapy and Chemotherapy with or Without Radiation in the First-Line Treatment of Advanced Colorectal Cancer","sponsor":"Fudan University","started":"2025-03-01","startedType":"actual","enrolled":208,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00563836","kind":"trial","name":"Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer","aka":[],"tldr":"A phase 2 trial of Catumaxomab in Ovarian cancer, run by Neovii Biotech, completed.","summary":"Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer is a phase 2 interventional study registered as NCT00563836 by Neovii Biotech, with 41 participants recorded, started 2007-11 and reaching its primary completion in 2008-09. Interventions recorded: Catumaxomab. Conditions recorded: Ovarian Cancer, Epithelial Ovarian Cancer.\n\nLinked to the drug Catumaxomab because the registry names it among its interventions and Ovarian cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00563836","url":"https://clinicaltrials.gov/study/NCT00563836"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["catumaxomab"],"companies":["neovii"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00563836","phase":"2","setting":"Multicenter, Single-arm, Phase II Study of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intra- and Postoperatively in Patients With Epithelial Ovarian Cancer","sponsor":"Neovii Biotech","started":"2007-11","enrolled":41,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07670273","kind":"trial","name":"Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of trastuzumab rezetecan, adebrelimab and lenvatinib in gallbladder cancer and other biliary tract cancers, run by Peking Union Medical College Hospital, now recruiting.","summary":"Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer is a phase 2 interventional study registered as NCT07670273 by Peking Union Medical College Hospital, with a registry enrolment figure of 70 participants, started 2026-04-29 and due to reach its primary completion in 2027-04-29. Interventions recorded: Trastuzumab Rezetecan, Adebrelimab, Lenvatinib. Conditions listed: Biliary Tract Neoplasms Immunotherapy. Gallbladder cancer is named in the registry entry: \"3. Locally advanced or metastatic cholangiocarcinoma, including cholangiocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma) and gallbladder cancer, which has been confirmed by pathological histo\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07670273","url":"https://clinicaltrials.gov/study/NCT07670273"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","adebrelimab","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07670273","phase":"2","setting":"A Prospective, Open-label, Multicenter Phase II Clinical Study of Rikang Trastuzumab in Combination With Adebrelimab and Lenvatinib for First-line Treatment of HER2-positive or Low-expressing Locally Advanced or Metastatic Biliary Tract Cancer","sponsor":"Peking Union Medical College Hospital","started":"2026-04-29","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07704177","kind":"trial","name":"Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib in Advanced HER2-Positive/Low-Expression Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of trastuzumab rezetecan, adebrelimab and lenvatinib in gallbladder cancer and other biliary tract cancers, run by Peking Union Medical College Hospital, now recruiting.","summary":"Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib in Advanced HER2-Positive/Low-Expression Biliary Tract Cancer is a phase 2 interventional study registered as NCT07704177 by Peking Union Medical College Hospital, with a registry enrolment figure of 70 participants, started 2026-04-15 and due to reach its primary completion in 2027-04-15. Interventions recorded: Trastuzumab Rezetecan, Adebrelimab, Lenvatinib. Conditions listed: Biliary Tract Neoplasms Immunotherapy. Gallbladder cancer is named in the registry entry: \"3. Locally advanced or metastatic cholangiocarcinoma confirmed by pathological histology or cytology, including cholangiocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma) and gallbladder cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07704177","url":"https://clinicaltrials.gov/study/NCT07704177"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","adebrelimab","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07704177","phase":"2","setting":"A Prospective, Open-Label, Multicenter Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib for HER2-Positive or Low-Expression Locally Advanced or Metastatic Biliary Tract Cancer in the Second-Line or Later Setting","sponsor":"Peking Union Medical College Hospital","started":"2026-04-15","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07234877","kind":"trial","name":"Phase II Study of Upfront SRT Plus Ivonescimab/Chemotherapy vs Ivonescimab/Chemotherapy in NSCLC Brain Mets","aka":[],"tldr":"A phase 2 trial of ivonescimab, carboplatin, pemetrexed, paclitaxel / nab-paclitaxel and other drugs in lung cancer, run by European Organisation for Research and Treatment of Cancer - EORTC, not yet recruiting.","summary":"Phase II Study of Upfront SRT Plus Ivonescimab/Chemotherapy vs Ivonescimab/Chemotherapy in NSCLC Brain Mets is a phase 2, randomised interventional study registered as NCT07234877 by European Organisation for Research and Treatment of Cancer - EORTC, with a registry enrolment figure of 158 participants, started 2026-11 and due to reach its primary completion in 2032-01. Interventions recorded: Ivonescimab; Carboplatin; Pemetrexed; Paclitaxel; Paclitaxel-albumin; Stereotactic Radiosurgery (SRS) or Fractionated Stereotactic Radiotherapy (FSRT). Conditions listed: Non Small Cell Lung Cancer. Primary outcome: Intracranial progression-free survival based on local assessment using RANO-BM criteria. Lung eligibility wording from the registry: \"* Patients with pathology proven metastatic NSCLC without an actionable genomic alteration for which there is first line targeted treatment approved by EMA and recommended by the ESMO guidelines\". Sites: Austria, France, Germany, Greece, Italy, Netherlands, Slovenia, Spain. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07234877","url":"https://clinicaltrials.gov/study/NCT07234877"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","bispecific-antibody","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","sbrt"],"targets":[],"drugs":["ivonescimab","carboplatin","pemetrexed","paclitaxel","nab-paclitaxel"],"companies":["summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07234877","phase":"2","setting":"A Randomized Phase II Study Evaluating Upfront SRT to All Brain Metastases Followed by Ivonescimab Plus Chemotherapy Versus Upfront Ivonescimab Plus Chemotherapy in Patients With Asymptomatic Active Brain Metastases From NSCLC","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","started":"2026-11","startedType":"estimated","enrolled":158,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02485652","kind":"trial","name":"Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung","aka":[],"tldr":"A phase 2 trial of Olmutinib in Non-small-cell lung cancer, run by Hanmi Pharmaceutical Company Limited, recorded as terminated on the registry.","summary":"Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung is a phase 2 interventional study registered as NCT02485652 by Hanmi Pharmaceutical Company Limited, with 162 participants recorded, started 2015-08-31 and due to reach its primary completion in 2020-12-08. Interventions recorded: HM61713. Conditions recorded: Non Small Cell Lung Cancer.\n\nLinked to the drug Olmutinib because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02485652","url":"https://clinicaltrials.gov/study/NCT02485652"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["olmutinib"],"companies":["hanmi-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02485652","phase":"2","setting":"A Single Arm, Open-label, Phase 2 Study Evaluating the Efficacy, Safety and PK of HM61713 in Patients With T790M-positive NSCLC After Treatment With an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor","sponsor":"Hanmi Pharmaceutical Company Limited","started":"2015-08-31","startedType":"actual","enrolled":162,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07017673","kind":"trial","name":"Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of ivonescimab, carboplatin and docetaxel in triple-negative breast cancer, run by Cedars-Sinai Medical Center, now recruiting.","summary":"Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer is a phase 2, interventional study registered as NCT07017673 by Cedars-Sinai Medical Center, with a registry enrolment figure of 34 participants, started 2025-07-25 and due to reach its primary completion in 2027-12. Interventions recorded: Ivonescimab; Carboplatin; Docetaxel. Conditions listed: TNBC; TNBC - Triple-Negative Breast Cancer; Early Stage Triple-Negative Breast Carcinoma. Triple-negative eligibility wording from the registry: \"* High-risk early stage triple negative breast cancer (TNBC), defined by ER≤10%, PR≤10% and HER2 negative (by IHC or FISH), per ASCO/CAP guidelines\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07017673","url":"https://clinicaltrials.gov/study/NCT07017673"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["ivonescimab","carboplatin","docetaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07017673","phase":"2","setting":"Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early Stage Triple Negative Breast Cancer","sponsor":"Cedars-Sinai Medical Center","started":"2025-07-25","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05672108","kind":"trial","name":"Phase II Trial of Lung Chemoemobolization","aka":[],"tldr":"A phase 2 trial of ethiodized oil and mitomycin C in colorectal cancer, run by City of Hope Medical Center, now recruiting.","summary":"Phase II Trial of Lung Chemoemobolization is a phase 2, interventional study registered as NCT05672108 by City of Hope Medical Center, with a registry enrolment figure of 30 participants, started 2023-05-12 and due to reach its primary completion in 2027-10-28. Interventions recorded: Computed Tomography; Ethiodized Oil; Mitomycin; Transarterial Chemoembolization; Tris-acryl Gelatin Microspheres. Conditions listed: Lung Non-Small Cell Carcinoma; Mediastinal Neoplasm; Pleural Neoplasm; Lung Metastases From Any Primary; Endobronchial Metastases; Colon Cancer; Sarcoma. Primary outcome: Local progression free survival; Incidence of adverse events. Colorectal eligibility wording from the registry: \"* Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, magnetic resonance imaging \\[MRI\\], or direct pressure measurement)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05672108","url":"https://clinicaltrials.gov/study/NCT05672108"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["ethiodized-oil","mitomycin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05672108","phase":"2","setting":"Phase II Trial of Lung Chemoemobolization","sponsor":"City of Hope Medical Center","started":"2023-05-12","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05280314","kind":"trial","name":"Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors","aka":[],"tldr":"A phase 2 trial of IO102-IO103 in melanoma, run by IO Biotech, now recruiting.","summary":"Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors is a phase 2 interventional study registered as NCT05280314 by IO Biotech, with 60 participants planned, started 2023-12-21 and due to reach its primary completion in 2025-04-30. Interventions recorded: IO102-IO103, Pembrolizumab KEYTRUDA®. Conditions listed: Melanoma, Squamous Cell Carcinoma of Head and Neck. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05280314","url":"https://clinicaltrials.gov/study/NCT05280314"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["io102-io103"],"companies":["io-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05280314","phase":"2","setting":"Phase II, Multi-cohort Trial of Neoadjuvant and Post-surgery IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Selected Resectable Tumors","sponsor":"IO Biotech","started":"2023-12-21","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00299689","kind":"trial","name":"Phase II Trial of Ontak With Metastatic Melanoma","aka":[],"tldr":"A phase 2 trial of Denileukin diftitox in Melanoma, run by James Graham Brown Cancer Center, completed.","summary":"Phase II Trial of Ontak With Metastatic Melanoma is a phase 2 interventional study registered as NCT00299689 by James Graham Brown Cancer Center, with 69 participants recorded, started 2006-03 and reaching its primary completion in 2010-01. Interventions recorded: Denileukin diftitox. Conditions recorded: Malignant Melanoma.\n\nLinked to the drug Denileukin diftitox because the registry names it among its interventions and Melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00299689","url":"https://clinicaltrials.gov/study/NCT00299689"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["denileukin-diftitox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00299689","phase":"2","setting":"Phase II Trial of ONTAK With Metastatic Melanoma","sponsor":"James Graham Brown Cancer Center","started":"2006-03","yearReported":2014,"enrolled":69,"enrolledBasis":"registry","outcomes":[{"endpoint":"Positive Response Defined as Clinical Complete Response, Partial Response or Stable Disease (Persisting for at Least 4 Weeks) as Measure by Modified RECIST Criteria","primary":true,"unit":"participants","arms":[{"name":"Intervention","n":16,"value":16,"note":"Figures from the ClinicalTrials.gov results section (first posted 2014-09-05), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00299689?tab=results"}]},{"id":"nct07552181","kind":"trial","name":"Phase II Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Yuan Yuan, not yet recruiting.","summary":"Phase II Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer is a phase 2, interventional study registered as NCT07552181 by Yuan Yuan, with a registry enrolment figure of 50 participants, started 2026-09 and due to reach its primary completion in 2035-09. Interventions recorded: Live biotherapeutic product: MO-03 1 capsule PO BID. Conditions listed: TNBC - Triple-Negative Breast Cancer; TNBC; Early Stage Triple-Negative Breast Carcinoma. Triple-negative eligibility wording from the registry: \"* Patients with high-risk early stage triple negative breast cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07552181","url":"https://clinicaltrials.gov/study/NCT07552181"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07552181","phase":"2","setting":"Phase II Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer","sponsor":"Yuan Yuan","started":"2026-09","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02444819","kind":"trial","name":"Phase II Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line NSCLC Anticancer Therapy","aka":[],"tldr":"A phase 2 trial of Olmutinib in Non-small-cell lung cancer, run by Hanmi Pharmaceutical Company Limited, completed.","summary":"Phase II Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line NSCLC Anticancer Therapy is a phase 2 interventional study registered as NCT02444819 by Hanmi Pharmaceutical Company Limited, with 33 participants recorded, started 2015-03 and reaching its primary completion in 2017-08. Interventions recorded: HM61713. Conditions recorded: Non Small Cell Lung Cancer.\n\nLinked to the drug Olmutinib because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02444819","url":"https://clinicaltrials.gov/study/NCT02444819"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["olmutinib"],"companies":["hanmi-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02444819","phase":"2","setting":"A Multicenter, Single-arm, Phase II Exploratory Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line Anticancer Agent in NSCLC Patients With EGFR Mutation","sponsor":"Hanmi Pharmaceutical Company Limited","started":"2015-03","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06121505","kind":"trial","name":"Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of sintilimab in lung cancer, run by Sichuan University, now recruiting.","summary":"Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer is a phase 2, randomised interventional study registered as NCT06121505 by Sichuan University, with a registry enrolment figure of 114 participants, started 2024-03-01 and due to reach its primary completion in 2027-02-28. Interventions recorded: low-dose radiation therapy and stereotactic body radiation therapy; chemotherapy; Sintilimab. Conditions listed: Lung Squamous Cell Carcinoma. Primary outcome: objective response rate (ORR). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed squamous cell lung cancer, imaging confirmed locally advanced or metastatic disease (unresectable or not eligible for definitive chemoradiotherapy, stage IIIB-IV);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06121505","url":"https://clinicaltrials.gov/study/NCT06121505"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","sbrt"],"targets":[],"drugs":["sintilimab"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06121505","phase":"2","setting":"Low-dose Radiation Therapy and Stereotactic Body Radiation Therapy Combined With PD-1 Inhibitor Sintilimab and Chemotherapy Versus PD-1 Inhibitor Combined With Chemotherapy as First-line Treatment for Patients With Locally Advanced or Metastatic Squamous Cell Lung Cancer: A Randomized, Phase II Multicenter Clinical Trial","sponsor":"Sichuan University","started":"2024-03-01","startedType":"actual","enrolled":114,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03334617","kind":"trial","name":"Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy","aka":["HUDSON"],"tldr":"A phase 2 trial of Durvalumab, Ceralasertib, Olaparib in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy is a phase 2 interventional study registered as NCT03334617 by AstraZeneca, with 528 participants enrolled, started 2017-12-18 and due to reach its primary completion in 2024-09-13. Interventions recorded: Durvalumab, Danvatirsen, Ceralasertib, Vistusertib, Olaparib. Conditions listed: Non-Small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03334617","url":"https://clinicaltrials.gov/study/NCT03334617"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["durvalumab","ceralasertib","olaparib","oleclumab","trastuzumab-deruxtecan"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03334617-nat-med-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03334617","phase":"2","setting":"An Open-Label, Multi-Drug, Biomarker-Directed, Multi-Centre Phase II Umbrella Study in Patients With Non-Small Cell Lung Cancer, Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (HUDSON).","sponsor":"AstraZeneca","started":"2017-12-18","startedType":"actual","yearReported":2025,"enrolled":528,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Objective Response Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1)","primary":true,"unit":"%","arms":[{"name":"Module 1 Cohort A.1.HRR: Durvalumab 1500 mg + Olaparib 300 mg","n":21,"value":9.5,"note":"80% CI 2.6 to 23.4; Figures from the ClinicalTrials.gov results section (first posted 2025-10-27), not from a publication"},{"name":"Module 1 Cohort A.1.LKB: Durvalumab 1500 mg + Olaparib 300 mg","n":21,"value":4.8,"note":"80% CI 0.5 to 17.3"},{"name":"Module 1 Cohort B.1.PRI: Durvalumab 1500 mg + Olaparib 300 mg","n":22,"value":0,"note":"80% CI 0.0 to 9.9"},{"name":"Module 1 Cohort B.1.ACQ: Durvalumab 1500 mg + Olaparib 300 mg","n":23,"value":4.3,"note":"80% CI 0.5 to 15.9"},{"name":"Module 2 Cohort B.2.PRI: Durvalumab 1500 mg + Danvatirsen 200 mg","n":23,"value":0,"note":"80% CI 0.0 to 9.5"},{"name":"Module 2 Cohort B.2.ACQ: Durvalumab 1500 mg + Danvatirsen 200 mg","n":22,"value":0,"note":"80% CI 0.0 to 9.9"},{"name":"Module 3 Cohort A.3.ATM: Durvalumab 1500 mg + AZD6738 240 mg","n":31,"value":25.8,"note":"80% CI 15.7 to 38.5"},{"name":"Module 3 Cohort B.3.PRI: Durvalumab 1500 mg + AZD6738 240 mg","n":37,"value":8.1,"note":"80% CI 3.0 to 17.2"},{"name":"Module 3 Cohort B.3.ACQ: Durvalumab 1500 mg + AZD6738 240 mg","n":58,"value":8.6,"note":"80% CI 4.3 to 15.4"},{"name":"Module 4 Cohort A.4.RIC: Durvalumab 1500 mg + Vistusertib 125 mg","n":1,"note":"No efficacy data were collected as the module was prematurely discontinued by the sponsor for strategic reasons. At the time of decision to discontinue the mod…"},{"name":"Module 5 Cohort A.5.73H: Durvalumab 1500 mg + Oleclumab 3000 mg","n":23,"value":4.3,"note":"80% CI 0.5 to 15.9"},{"name":"Module 5 Cohort B.5.PRI: Durvalumab 1500 mg + Oleclumab 3000 mg","n":9,"value":0,"note":"80% CI 0.0 to 22.6"},{"name":"Module 5 Cohort B.5.ACQ: Durvalumab 1500 mg + Oleclumab 3000 mg","n":25,"value":4,"note":"80% CI 0.4 to 14.7"},{"name":"Module 6 Cohort A.6.HER2e: Durvalumab 1120 mg + Trastuzumab Deruxtecan 5.4mg/kg","n":23,"value":21.7,"note":"80% CI 11.0 to 36.6"},{"name":"Module 6 Cohort A.6.HER2m: Durvalumab 1120 mg + Trastuzumab Deruxtecan 5.4mg/kg","n":20,"value":35,"note":"80% CI 20.7 to 51.8"},{"name":"Module 7 Cohort B.7.ACQ: Durvalumab 1500 mg + Cediranib 20 mg","n":22,"value":22.7,"note":"80% CI 11.5 to 38.1"},{"name":"Module 8 Cohort A.8.ATM: Ceralasertib 240 mg","n":15,"value":0,"note":"80% CI 0.0 to 14.2"},{"name":"Module 9 Cohort B.9.PRI: Durvalumab 1500 mg + Ceralasertib 240 mg","n":18,"value":16.7,"note":"80% CI 6.3 to 33.4"},{"name":"Module 9 Cohort B.9.ACQ: Durvalumab 1500 mg + Ceralasertib 240 mg","n":24,"value":8.3,"note":"80% CI 2.2 to 20.7"},{"name":"Module 10 Cohort C.10.160: Durvalumab 1500 mg + Ceralasertib 160 mg","n":34,"value":0,"note":"80% CI 0.0 to 6.5"},{"name":"Module 10 Cohort C.10.240: Durvalumab 1500 mg + Ceralasertib 240 mg","n":17,"value":11.8,"note":"80% CI 3.2 to 28.4"},{"name":"Module 11 Cohort C.11.240: AZD6738 240 mg","n":38,"value":2.6,"note":"80% CI 0.3 to 9.9"}],"source":"https://clinicaltrials.gov/study/NCT03334617?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Module 1 Cohort A.1.HRR: Durvalumab 1500 mg + Olaparib 300 mg","n":21,"value":9.63,"note":"80% CI 5.26 to 15.97; Figures from the ClinicalTrials.gov results section (first posted 2025-10-27), not from a publication"},{"name":"Module 1 Cohort A.1.LKB: Durvalumab 1500 mg + Olaparib 300 mg","n":21,"value":5.75,"note":"80% CI 5.29 to 10.84"},{"name":"Module 1 Cohort B.1.PRI: Durvalumab 1500 mg + Olaparib 300 mg","n":22,"value":7.16,"note":"80% CI 4.93 to 10.28"},{"name":"Module 1 Cohort B.1.ACQ: Durvalumab 1500 mg + Olaparib 300 mg","n":23,"value":15.51,"note":"80% CI 9.33 to 20.86"},{"name":"Module 2 Cohort B.2.PRI: Durvalumab 1500 mg + Danvatirsen 200 mg","n":23,"value":6.01,"note":"80% CI 3.55 to 6.51"},{"name":"Module 2 Cohort B.2.ACQ: Durvalumab 1500 mg + Danvatirsen 200 mg","n":22,"value":11.2,"note":"80% CI 9.72 to 12.55"},{"name":"Module 3 Cohort A.3.ATM: Durvalumab 1500 mg + AZD6738 240 mg","n":31,"value":15.8,"note":"80% CI 14.16 to 22.80"},{"name":"Module 3 Cohort B.3.PRI: Durvalumab 1500 mg + AZD6738 240 mg","n":38,"value":10.22,"note":"80% CI 5.82 to 11.30"},{"name":"Module 3 Cohort B.3.ACQ: Durvalumab 1500 mg + AZD6738 240 mg","n":58,"value":11.37,"note":"80% CI 9.13 to 15.80"},{"name":"Module 4 Cohort A.4.RIC: Durvalumab 1500 mg + Vistusertib 125 mg","n":1,"note":"No efficacy data were collected as the module was prematurely discontinued by the sponsor for strategic reasons. At the time of decision to discontinue the mod…"},{"name":"Module 5 Cohort A.5.73H: Durvalumab 1500 mg + Oleclumab 3000 mg","n":23,"value":10.97,"note":"80% CI 7.59 to 15.74"},{"name":"Module 5 Cohort B.5.PRI: Durvalumab 1500 mg + Oleclumab 3000 mg","n":9,"value":7.06,"note":"80% CI 4.90 to 11.99"},{"name":"Module 5 Cohort B.5.ACQ: Durvalumab 1500 mg + Oleclumab 3000 mg","n":25,"value":12.78,"note":"80% CI 7.39 to 20.96"},{"name":"Module 6 Cohort A.6.HER2e: Durvalumab 1120 mg + Trastuzumab Deruxtecan 5.4mg/kg","n":23,"value":9.53,"note":"80% CI 6.57 to 12.42"},{"name":"Module 6 Cohort A.6.HER2m: Durvalumab 1120 mg + Trastuzumab Deruxtecan 5.4mg/kg","n":20,"value":10.61,"note":"80% CI 8.90 to 20.60"},{"name":"Module 7 Cohort B.7.ACQ: Durvalumab 1500 mg + Cediranib 20 mg","n":22,"value":14.19,"note":"80% CI 11.86 to 19.88"},{"name":"Module 8 Cohort A.8.ATM: Ceralasertib 240 mg","n":15,"value":14.23,"note":"80% CI 6.08 to 17.18"},{"name":"Module 9 Cohort B.9.PRI: Durvalumab 1500 mg + Ceralasertib 240 mg","n":19,"value":7.95,"note":"80% CI 5.59 to 8.64"},{"name":"Module 9 Cohort B.9.ACQ: Durvalumab 1500 mg + Ceralasertib 240 mg","n":24,"value":12.91,"note":"80% CI 7.39 to 20.50"},{"name":"Module 10 Cohort C.10.160: Durvalumab 1500 mg + Ceralasertib 160 mg","n":34,"value":5.95,"note":"80% CI 4.01 to 10.05"},{"name":"Module 10 Cohort C.10.240: Durvalumab 1500 mg + Ceralasertib 240 mg","n":17,"value":7.03,"note":"80% CI 4.37 to 12.71"},{"name":"Module 11 Cohort C.11.240: AZD6738 240 mg","n":38,"value":6.6,"note":"80% CI 5.85 to 9.13"}],"source":"https://clinicaltrials.gov/study/NCT03334617?tab=results"},{"endpoint":"Progression-Free Survival (PFS) Per RECIST v1.1","unit":"months","arms":[{"name":"Module 1 Cohort A.1.HRR: Durvalumab 1500 mg + Olaparib 300 mg","n":21,"value":2.79,"note":"80% CI 1.41 to 5.26; Figures from the ClinicalTrials.gov results section (first posted 2025-10-27), not from a publication"},{"name":"Module 1 Cohort A.1.LKB: Durvalumab 1500 mg + Olaparib 300 mg","n":21,"value":1.41,"note":"80% CI 1.38 to 1.81"},{"name":"Module 1 Cohort B.1.PRI: Durvalumab 1500 mg + Olaparib 300 mg","n":22,"value":3.38,"note":"80% CI 2.10 to 4.93"},{"name":"Module 1 Cohort B.1.ACQ: Durvalumab 1500 mg + Olaparib 300 mg","n":23,"value":4.17,"note":"80% CI 2.69 to 4.37"},{"name":"Module 2 Cohort B.2.PRI: Durvalumab 1500 mg + Danvatirsen 200 mg","n":23,"value":1.68,"note":"80% CI 1.64 to 2.99"},{"name":"Module 2 Cohort B.2.ACQ: Durvalumab 1500 mg + Danvatirsen 200 mg","n":22,"value":3.09,"note":"80% CI 2.83 to 6.14"},{"name":"Module 3 Cohort A.3.ATM: Durvalumab 1500 mg + AZD6738 240 mg","n":31,"value":7.43,"note":"80% CI 5.59 to 9.43"},{"name":"Module 3 Cohort B.3.PRI: Durvalumab 1500 mg + AZD6738 240 mg","n":38,"value":2.96,"note":"80% CI 1.91 to 3.09"},{"name":"Module 3 Cohort B.3.ACQ: Durvalumab 1500 mg + AZD6738 240 mg","n":58,"value":4.21,"note":"80% CI 3.02 to 4.96"},{"name":"Module 4 Cohort A.4.RIC: Durvalumab 1500 mg + Vistusertib 125 mg","n":1,"note":"No efficacy data were collected as the module was prematurely discontinued by the sponsor for strategic reasons. At the time of decision to discontinue the mod…"},{"name":"Module 5 Cohort A.5.73H: Durvalumab 1500 mg + Oleclumab 3000 mg","n":23,"value":1.61,"note":"80% CI 1.41 to 2.76"},{"name":"Module 5 Cohort B.5.PRI: Durvalumab 1500 mg + Oleclumab 3000 mg","n":9,"value":1.41,"note":"80% CI 1.35 to 1.81"},{"name":"Module 5 Cohort B.5.ACQ: Durvalumab 1500 mg + Oleclumab 3000 mg","n":25,"value":2.69,"note":"80% CI 1.74 to 4.17"},{"name":"Module 6 Cohort A.6.HER2e: Durvalumab 1120 mg + Trastuzumab Deruxtecan 5.4mg/kg","n":23,"value":2.83,"note":"80% CI 2.33 to 5.45"},{"name":"Module 6 Cohort A.6.HER2m: Durvalumab 1120 mg + Trastuzumab Deruxtecan 5.4mg/kg","n":20,"value":5.52,"note":"80% CI 5.32 to 5.72"},{"name":"Module 7 Cohort B.7.ACQ: Durvalumab 1500 mg + Cediranib 20 mg","n":22,"value":4.17,"note":"80% CI 2.56 to 9.36"},{"name":"Module 8 Cohort A.8.ATM: Ceralasertib 240 mg","n":15,"value":3.42,"note":"80% CI 2.14 to 7.62"},{"name":"Module 9 Cohort B.9.PRI: Durvalumab 1500 mg + Ceralasertib 240 mg","n":19,"value":1.48,"note":"80% CI 1.41 to 2.23"},{"name":"Module 9 Cohort B.9.ACQ: Durvalumab 1500 mg + Ceralasertib 240 mg","n":24,"value":3.68,"note":"80% CI 2.83 to 7.33"},{"name":"Module 10 Cohort C.10.160: Durvalumab 1500 mg + Ceralasertib 160 mg","n":34,"value":1.68,"note":"80% CI 1.61 to 2.56"},{"name":"Module 10 Cohort C.10.240: Durvalumab 1500 mg + Ceralasertib 240 mg","n":17,"value":2,"note":"80% CI 1.71 to 2.79"},{"name":"Module 11 Cohort C.11.240: AZD6738 240 mg","n":38,"value":2.86,"note":"80% CI 2.73 to 3.02"}],"source":"https://clinicaltrials.gov/study/NCT03334617?tab=results"}]},{"id":"nct07106892","kind":"trial","name":"Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of HLX43 Dose 1; in colorectal cancer, run by Shanghai Henlius Biotech, now recruiting.","summary":"Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Colorectal Cancer is a phase 2 interventional study registered as NCT07106892 by Shanghai Henlius Biotech, with 60 participants planned, started 2025-09-15 and due to reach its primary completion in 2026-12-30. Interventions recorded: HLX43 Dose 1;, HLX43 Dose 2; and HLX43 Dose 3;.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07106892","url":"https://clinicaltrials.gov/study/NCT07106892"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07106892","phase":"2","setting":"Phase II, Open-label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Colorectal Cancer","sponsor":"Shanghai Henlius Biotech","started":"2025-09-15","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05744687","kind":"trial","name":"Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer","aka":[],"tldr":"A phase 2/3 trial testing SPH4336 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer is a phase 2/3 interventional study registered as NCT05744687, led by Shanghai Pharmaceuticals, and recruiting on the registry. Official title: Randomised, Double-blind, Placebo-controlled, Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer. Planned enrolment is 374 participants (estimated). The study started in 2023-04-24 and primary completion is expected in 2026-05-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05744687","url":"https://clinicaltrials.gov/study/NCT05744687"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["sph4336"],"companies":["shanghai-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05744687","phase":"2/3","setting":"Randomized, Double-blind, Placebo-controlled, Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer","sponsor":"Shanghai Pharmaceuticals","started":"2023-04-24","startedType":"actual","enrolled":374,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07290088","kind":"trial","name":"Phase II/III Trial of PRL3-Zumab in Advanced Solid Tumor Patients","aka":[],"tldr":"A phase 2/3 trial of PRL3-ZUMAB in advanced solid tumours, run by Intra-IMMUSG Pte Ltd, now recruiting.","summary":"Phase II/III Trial of PRL3-Zumab in Advanced Solid Tumor Patients is a phase 2/3 interventional study registered as NCT07290088 by Intra-IMMUSG Pte Ltd, with 52 participants planned, started 2023-01-09 and due to reach its primary completion in 2026-12. Interventions recorded: PRL3-ZUMAB.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07290088","url":"https://clinicaltrials.gov/study/NCT07290088"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["intra-immusg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07290088","phase":"2/3","setting":"An Open Label, Multicenter, Safety and Efficacy Phase II/III Study of PRL3-Zumab in Solid Tumor Patients","sponsor":"Intra-IMMUSG Pte Ltd","started":"2023-01-09","startedType":"actual","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07232290","kind":"trial","name":"Phase IIa Study of Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera","aka":[],"tldr":"A phase 2 trial of Flonoltinib 75mg in myeloproliferative neoplasms, run by Chengdu Zenitar Biomedical Technology Co., Ltd, now recruiting.","summary":"Phase IIa Study of Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera is a phase 2 interventional study registered as NCT07232290 by Chengdu Zenitar Biomedical Technology Co., Ltd, with 60 participants planned, started 2025-09-23 and due to reach its primary completion in 2027-07-30. Interventions recorded: Flonoltinib 75mg, Flonoltinib 100mg, Flonoltinib 125mg and Extended Phase Dose Group.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07232290","url":"https://clinicaltrials.gov/study/NCT07232290"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms"],"sections":[],"technologies":[],"targets":[],"drugs":["flonoltinib"],"companies":["chengdu-zenitar-biomedical-technology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07232290","phase":"2","setting":"An Open Label, Randomized, Parallel Controlled, Multicenter Phase IIa Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Flonoltinib Maleate Tablets in the Treatment of Hydroxyurea or Interferon Resistant/Intolerant Polycythemia Vera","sponsor":"Chengdu Zenitar Biomedical Technology Co., Ltd","started":"2025-09-23","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07310173","kind":"trial","name":"Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma","aka":[],"tldr":"A phase 2 trial of Regorafenib in hepatocellular carcinoma, run by Zhejiang Hisun Pharmaceutical Co. Ltd., now recruiting.","summary":"Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma is a phase 2 interventional study registered as NCT07310173 by Zhejiang Hisun Pharmaceutical Co. Ltd., with 75 participants planned, started 2026-01-01 and due to reach its primary completion in 2027-10-01. Interventions recorded: AST-3424, Regorafenib Tablets. Conditions listed: HCC - Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07310173","url":"https://clinicaltrials.gov/study/NCT07310173"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["regorafenib"],"companies":["zhejiang-hisun"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07310173","phase":"2","setting":"Phase IIb, Randomized, Active-Controlled, Parallel-Group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AST-3424 in Patients With AKR1C3-High Expressing Advanced Hepatocellular Carcinoma Who Progressed After Systemic Therapy With Immune Checkpoint Inhibitors","sponsor":"Zhejiang Hisun Pharmaceutical Co. Ltd.","started":"2026-01-01","startedType":"estimated","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07360132","kind":"trial","name":"Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-Line Treatment of Advanced Squamous","aka":[],"tldr":"A phase 3 trial of carboplatin and paclitaxel / nab-paclitaxel in lung cancer, run by Shanghai Huaota Biopharmaceutical Co., Ltd., not yet recruiting.","summary":"Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT07360132 by Shanghai Huaota Biopharmaceutical Co., Ltd., with a registry enrolment figure of 480 participants, started 2026-01-15 and due to reach its primary completion in 2028-04-10. Interventions recorded: Carboplatin Injection; Paclitaxel Injection. Conditions listed: Squamous Non-small Cell Lung Cancer. Primary outcome: Progression-free survival (PFS). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) (confirmed per the 9th Edition of the TNM Staging System for Lung Cancer by the Union for International Cancer Control \\[UICC\\] and the American Joint Committee on\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07360132","url":"https://clinicaltrials.gov/study/NCT07360132"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-squamous-cell-carcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","paclitaxel"],"companies":["huabo-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07360132","phase":"3","setting":"A Randomized, Double-Blind, Multicenter Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-Line Treatment of Advanced or Metastatic Squamous Non-Small Cell Lung Cancer","sponsor":"Shanghai Huaota Biopharmaceutical Co., Ltd.","started":"2026-01-15","startedType":"estimated","enrolled":480,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07383116","kind":"trial","name":"Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Advanced Nonsquamous No","aka":[],"tldr":"A phase 3 trial of pemetrexed, carboplatin, cisplatin and tislelizumab in lung cancer, run by Shanghai Huaota Biopharmaceutical Co., Ltd., not yet recruiting.","summary":"Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT07383116 by Shanghai Huaota Biopharmaceutical Co., Ltd., with a registry enrolment figure of 500 participants, started 2026-01-15 and due to reach its primary completion in 2028-04-10. Interventions recorded: Pemetrexed injection; Carboplatin Injection; Cisplatin injection; HB0025 Injection; Tislelizumab. Conditions listed: Non Squamous Non-small Cell Lung Cancer. Primary outcome: Progression-free survival (PFS). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-squamous non-small cell lung cancer (NSCLC) (confirmed per the 9th Edition of the TNM Staging System for Lung Cancer by the Union for International Cancer Control \\[UICC\\] and the American Joint\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07383116","url":"https://clinicaltrials.gov/study/NCT07383116"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pemetrexed","carboplatin","cisplatin","tislelizumab"],"companies":["huabo-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07383116","phase":"3","setting":"A Randomized, Double-Blind, Multicenter Phase III Clinical Study of HB0025 Injection Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer","sponsor":"Shanghai Huaota Biopharmaceutical Co., Ltd.","started":"2026-01-15","startedType":"estimated","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06658353","kind":"trial","name":"Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors","aka":[],"tldr":"A phase 3 trial testing VC004, now recruiting.","summary":"Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumours is a phase 3 interventional study registered as NCT06658353, led by Jiangsu vcare pharmaceutical technology co., and recruiting on the registry. Official title: Single-arm, Open, Multi-centre Phase III Clinical Study to Assess the Safety and Effectiveness of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumours. Planned enrolment is 54 participants (estimated). The study started in 2025-03-17 and primary completion is expected in 2026-12-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06658353","url":"https://clinicaltrials.gov/study/NCT06658353"}],"tags":["ctgov-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":["vc004"],"companies":[],"institutions":[],"pathways":[],"terms":["single-arm","metastasis"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06658353","phase":"3","setting":"Single-arm, Open, Multi-center Phase III Clinical Study to Assess the Safety and Effectiveness of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors","sponsor":"Jiangsu vcare pharmaceutical technology co.","started":"2025-03-17","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02453282","kind":"trial","name":"Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)","aka":["MYSTIC"],"tldr":"A phase 3 trial of Durvalumab, Tremelimumab, Carboplatin, Gemcitabine + cisplatin, Gemcitabine and Cisplatin in non-small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC) is a phase 3 interventional study registered as NCT02453282 by AstraZeneca, with 1118 participants enrolled, started 2015-07-21 and due to reach its primary completion in 2018-10-04. Interventions recorded: MEDI4736 (Durvalumab), MEDI4736 (Durvalumab)+Tremelimumab, Paclitaxel + Carboplatin, Gemcitabine + Cisplatin, Gemcitabine + Carboplatin and Pemetrexed + Cisplatin. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02453282","url":"https://clinicaltrials.gov/study/NCT02453282"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab","carboplatin","gemcitabine-cisplatin","gemcitabine","cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02453282-jama-oncol-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02453282","phase":"3","setting":"A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)(MYSTIC).","sponsor":"AstraZeneca","started":"2015-07-21","startedType":"actual","yearReported":2019,"enrolled":1118,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy","primary":true,"unit":"months","arms":[{"name":"Durvalumab Monotherapy","n":163,"value":16.3,"note":"95% CI 12.2 to 20.8; Figures from the ClinicalTrials.gov results section (first posted 2019-11-29), not from a publication"},{"name":"Durvalumab + Tremelimumab","n":163,"value":11.9,"note":"95% CI 9.0 to 17.7"},{"name":"SoC Chemotherapy","n":162,"value":12.9,"note":"95% CI 10.5 to 15.0"}],"source":"https://clinicaltrials.gov/study/NCT02453282?tab=results"},{"endpoint":"Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy","primary":true,"unit":"months","arms":[{"name":"Durvalumab + Tremelimumab","n":163,"value":3.9,"note":"95% CI 2.8 to 5.0; Figures from the ClinicalTrials.gov results section (first posted 2019-11-29), not from a publication"},{"name":"SoC Chemotherapy","n":162,"value":5.4,"note":"95% CI 4.6 to 5.8"}],"hr":1.05,"p":"0.705","source":"https://clinicaltrials.gov/study/NCT02453282?tab=results"},{"endpoint":"Objective Response Rate (ORR); PD-L1 (TC >=25%) Analysis Set Population","unit":"%","arms":[{"name":"Durvalumab Monotherapy","n":163,"value":35.6,"note":"Figures from the ClinicalTrials.gov results section (first posted 2019-11-29), not from a publication"},{"name":"Durvalumab + Tremelimumab","n":163,"value":34.4},{"name":"SoC Chemotherapy","n":162,"value":37.7}],"source":"https://clinicaltrials.gov/study/NCT02453282?tab=results"}]},{"id":"nct04842617","kind":"trial","name":"Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Ne","aka":[],"tldr":"A phase 3 trial of Dalpiciclib in male breast cancer, run by Jiangsu HengRui Medicine Co., Ltd., active and no longer recruiting.","summary":"Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative is a phase 3 interventional study registered as NCT04842617 by Jiangsu HengRui Medicine Co., Ltd., with 5274 participants enrolled, started 2021-04-30 and due to reach its primary completion in 2026-10-31. Interventions recorded: SHR6390, placebo. Conditions listed: Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04842617","url":"https://clinicaltrials.gov/study/NCT04842617"}],"tags":["ctgov-ingest"],"related":[],"cancers":["male-breast-cancer"],"sections":[],"technologies":["cdk46-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["dalpiciclib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04842617","phase":"3","setting":"A Multicenter, Randomized, Double-blind Phase III Study：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2021-04-30","startedType":"actual","enrolled":5274,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03869892","kind":"trial","name":"Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.","aka":["SOLSTICE"],"tldr":"A phase 3 trial of capecitabine in colorectal cancer, run by Institut de Recherches Internationales Servier, active but no longer recruiting.","summary":"Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy. is a phase 3, randomised interventional study registered as NCT03869892 by Institut de Recherches Internationales Servier, with a registry enrolment figure of 856 participants, started 2019-03-21 and due to reach its primary completion in 2021-06-29. Interventions recorded: Trifluridine/tipiracil hydrochloride (S95005); Capecitabine; Bevacizumab experimental; Bevacizumab control. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Progression-free Survival (PFS). Colorectal eligibility wording from the registry: \"Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded)\". Sites: Argentina, Australia, Austria, Brazil, Bulgaria, Czechia, Denmark, Estonia, France, Germany, Hungary, Ireland and 13 more countries. United Kingdom sites listed: 11. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03869892","url":"https://clinicaltrials.gov/study/NCT03869892"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Aberdeen Royal Infirmary Oncology Department (Aberdeen); University Hospitals Bristol Bristol Haematology & Oncology Centre (Bristol); St James's University Hospital (Leeds); Leicester Royal Infirmary The HOPE Clinical Trials Unit (Leicester); Royal Marsden Hospital Department of Medicine (London); Hammersmith Hospital Gary Weston Centre (London); Sarah Cannon Research Institute UK Clinical Trials (London); Imperial Healthcare NHS Trust Charing Cross Hospital (London); Christie Hospital NHS Foundation Trust GI & Endocrine (Manchester); Glan Clwyd Hospital North Wales Cancer Treatment Centre (Rhyl); Royal Marsden Hospital Department of Medicine (Sutton)."],"nct":"NCT03869892","phase":"3","setting":"An Open-label, Randomised, Phase III Study cOmparing trifLuridine/Tipiracil (S 95005) in Combination With Bevacizumab to Capecitabine in Combination With Bevacizumab in firST-line Treatment of Patients With metastatIC Colorectal Cancer Who Are Not candidatE for Intensive Therapy (SOLSTICE Study)","sponsor":"Institut de Recherches Internationales Servier","started":"2019-03-21","startedType":"actual","enrolled":856,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06396065","kind":"trial","name":"Phase III Study of AK112 for NSCLC Patients","aka":[],"tldr":"A phase 3 trial of Ivonescimab, Pemetrexed, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Summit Therapeutics, active and no longer recruiting.","summary":"Phase III Study of AK112 for NSCLC Patients is a phase 3 interventional study registered as NCT06396065 by Summit Therapeutics, with 420 participants enrolled, started 2023-05-04 and due to reach its primary completion in 2025-04-12. Interventions recorded: AK112 Injection, Placebo Injection. Conditions listed: Non-Squamous Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06396065","url":"https://clinicaltrials.gov/study/NCT06396065"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["ivonescimab","pemetrexed","carboplatin"],"companies":["summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct06396065-lancet-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06396065","phase":"3","setting":"A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment","sponsor":"Summit Therapeutics","started":"2023-05-04","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07291037","kind":"trial","name":"Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Acti","aka":["TROPION-Lung17"],"tldr":"A phase 3 trial of Datopotamab deruxtecan, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, now recruiting.","summary":"Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations is a phase 3 interventional study registered as NCT07291037 by AstraZeneca, with 400 participants planned, started 2025-10-31 and due to reach its primary completion in 2029-01-29. Interventions recorded: Datopotamab deruxtecan (Dato-DXd), Docetaxel. Conditions listed: Non-small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07291037","url":"https://clinicaltrials.gov/study/NCT07291037"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan","docetaxel"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07291037","phase":"3","setting":"A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)","sponsor":"AstraZeneca","started":"2025-10-31","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06123754","kind":"trial","name":"Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC","aka":[],"tldr":"A phase 3 trial of Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection in non-small-cell lung cancer, run by 3D Medicines (Sichuan) Co., Ltd., now recruiting.","summary":"Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC is a phase 3 interventional study registered as NCT06123754 by 3D Medicines (Sichuan) Co., Ltd., with 390 participants planned, started 2023-11-17 and due to reach its primary completion in 2027-12-30. Interventions recorded: Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection and placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06123754","url":"https://clinicaltrials.gov/study/NCT06123754"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["envafolimab"],"companies":["3d-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06123754","phase":"3","setting":"A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Envafolimab Plus Platinum-based Doublet Chemotherapy Versus Placebo Plus Platinum-based Doublet Chemotherapy in Patients With Non-small Cell Lung Cancer","sponsor":"3D Medicines (Sichuan) Co., Ltd.","started":"2023-11-17","startedType":"actual","enrolled":390,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07754123","kind":"trial","name":"Phase III Study of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With C797S+ NSCLC","aka":[],"tldr":"A phase 3 trial of cisplatin and carboplatin in lung cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd., not yet recruiting.","summary":"Phase III Study of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With C797S+ NSCLC is a phase 3, randomised interventional study registered as NCT07754123 by Jiangsu Hansoh Pharmaceutical Co., Ltd., with a registry enrolment figure of 206 participants, started 2026-09-17 and due to reach its primary completion in 2028-08-31. Interventions recorded: HS-10504; platinum-based doublet chemotherapy (Pemetrexed and Cisplatin/Carboplatin). Conditions listed: Advanced or Metastatic NSCLC. Primary outcome: Progression Free Survival (PFS). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB, IIIC, or IV)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07754123","url":"https://clinicaltrials.gov/study/NCT07754123"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin","carboplatin"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07754123","phase":"3","setting":"A Randomized, Controlled, Open-Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring EGFR C797S Mutation After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","started":"2026-09-17","startedType":"estimated","enrolled":206,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07228832","kind":"trial","name":"Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer","aka":["HARMONi-GI3"],"tldr":"A phase 3 trial of CAPOX, FLOT in colorectal cancer, run by Summit Therapeutics, now recruiting.","summary":"Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer is a phase 3 interventional study registered as NCT07228832 by Summit Therapeutics, with 600 participants planned, started 2025-11-18 and due to reach its primary completion in 2028-05-31. Interventions recorded: Drug: Ivonescimab Injection, Drug: Bevacizumab Injection. Conditions listed: Metastatic Colorectal Cancer (CRC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07228832","url":"https://clinicaltrials.gov/study/NCT07228832"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["capox","flot"],"companies":["summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07228832","phase":"3","setting":"A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer","sponsor":"Summit Therapeutics","started":"2025-11-18","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07829549","kind":"trial","name":"Phase III Study of RC148 Plus Chemotherapy Versus Tislelizumab Plus Chemotherapy as First-Line Treatment for Non-Squamous Non-Small Cell Lung Cancer Without Act","aka":[],"tldr":"A phase 3 trial of carboplatin and tislelizumab in lung cancer, run by RemeGen Co., Ltd., not yet recruiting.","summary":"Phase III Study of RC148 Plus Chemotherapy Versus Tislelizumab Plus Chemotherapy as First-Line Treatment for Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations is a phase 3, randomised interventional study registered as NCT07829549 by RemeGen Co., Ltd., with a registry enrolment figure of 540 participants, started 2026-09-30 and due to reach its primary completion in 2031-04. Interventions recorded: RC148 Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection; Tislelizumab Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection. Conditions listed: Previously Untreated Locally Advanced (IIIB/IIIC) or Metastatic (IV) e Nsq NSCLC Without Actionable Genomic Alterations. Primary outcome: Progression-Free Survival assessed by BIRC per RECIST v1.1. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not amenable to curative-intent therapy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07829549","url":"https://clinicaltrials.gov/study/NCT07829549"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","tislelizumab"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07829549","phase":"3","setting":"A Randomized, Double-blind, Multicenter Phase III Study of RC148 Combined With Platinum-Based Chemotherapy Versus Tislelizumab Combined With Platinum-Based Chemotherapy as First-Line Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations","sponsor":"RemeGen Co., Ltd.","started":"2026-09-30","startedType":"estimated","enrolled":540,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06921785","kind":"trial","name":"Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma","aka":["ARTEMIDE-HCC01"],"tldr":"A phase 3 trial of Tremelimumab, Rilvegostomig, Bevacizumab in hepatocellular carcinoma, run by AstraZeneca, now recruiting.","summary":"Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma is a phase 3 interventional study registered as NCT06921785 by AstraZeneca, with 1220 participants planned, started 2025-05-06 and due to reach its primary completion in 2030-03-15. Interventions recorded: Tremelimumab, Rilvegostomig, Bevacizumab, Atezolizumab. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06921785","url":"https://clinicaltrials.gov/study/NCT06921785"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["tremelimumab","rilvegostomig","bevacizumab","atezolizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06921785","phase":"3","setting":"A Phase III, Randomised, Open-label, Sponsor-blinded, Multicentre Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma","sponsor":"AstraZeneca","started":"2025-05-06","startedType":"actual","enrolled":1220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07170995","kind":"trial","name":"Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Adva","aka":[],"tldr":"A phase 3 trial of Tislelizumab in non-small-cell lung cancer and small-cell lung cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT07170995 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 460 participants planned, started 2025-10-22 and due to reach its primary completion in 2030-12. Interventions recorded: SHR-8068，adebelizumab and platinum-based chemotherapy, tislelizumab, and platinum-based chemotherapy. Conditions listed: Advanced or Metastatic Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07170995","url":"https://clinicaltrials.gov/study/NCT07170995"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07170995","phase":"3","setting":"A Randomized, Open-label, Controlled, Multicenter Phase III Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy Versus Tislelizumab Combined With Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-10-22","startedType":"actual","enrolled":460,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06459687","kind":"trial","name":"Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer","aka":[],"tldr":"A phase 3 trial of Socazolimab run by Lee's Pharmaceutical Limited in cervical cancer, now recruiting.","summary":"Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer is a phase 3 interventional study registered as NCT06459687 by Lee's Pharmaceutical Limited, with 440 participants planned, started 2024-11-28. Conditions listed: Cervical Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06459687","url":"https://clinicaltrials.gov/study/NCT06459687"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["socazolimab"],"companies":["lees-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06459687","phase":"3","setting":"Efficacy and Safety of Socazolimab Combined With Chemotherapy With or Without Bevacizumab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer: A Randomized, Double-blind, Placebo-controlled Phase III Study","sponsor":"Lee's Pharmaceutical Limited","started":"2024-11-28","startedType":"actual","enrolled":440,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06031558","kind":"trial","name":"Phase III Study of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Shouyao Holdings (Beijing) Co. LTD, active but no longer recruiting.","summary":"Phase III Study of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC is a phase 3, interventional study registered as NCT06031558 by Shouyao Holdings (Beijing) Co. LTD, with a registry enrolment figure of 120 participants, started 2023-10-31 and due to reach its primary completion in 2025-04-10. Interventions recorded: SY-5007. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Assessment of ORR by independent review committee (IRC).. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed diagnosis of locally advanced (with a tumor lesion that cannot be eradicated by surgery or radiotherapy as assessed by the investigators) or metastatic NSCLC\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06031558","url":"https://clinicaltrials.gov/study/NCT06031558"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["ret-fusion-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06031558","phase":"3","setting":"A Phase III, Open-Label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC.","sponsor":"Shouyao Holdings (Beijing) Co. LTD","started":"2023-10-31","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"fleteo","kind":"trial","name":"Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)","aka":["FLETEO"],"tldr":"A phase 3 trial testing TY-9591 in non-small-cell lung cancer, now recruiting.","summary":"Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO) is a phase 3 interventional study registered as NCT05382728, led by TYK Medicines, and recruiting on the registry. Official title: A Phase III, Randomised, Double-blind, Multi-centre Study to Assess the Efficacy and Safety of TY-9591 Tablets Versus Osimertinib as First Line Treatment in Patients With EGFR-sensitive Mutation, Locally Advanced or Metastatic Non Small Cell Lung Cancer. Planned enrolment is 680 participants (estimated). The study started in 2022-06-08 and primary completion is expected in 2025-05. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05382728","url":"https://clinicaltrials.gov/study/NCT05382728"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ty-9591"],"companies":["tyk-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05382728","phase":"3","setting":"A Phase III, Randomised, Double-blind, Multi-center Study to Assess the Efficacy and Safety of TY-9591 Tablets Versus Osimertinib as First Line Treatment in Patients With EGFR-sensitive Mutation, Locally Advanced or Metastatic Non Small Cell Lung Cancer","sponsor":"TYK Medicines","started":"2022-06-08","startedType":"actual","enrolled":680,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07262567","kind":"trial","name":"Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial testing GFH375 in pancreatic ductal adenocarcinoma, now recruiting.","summary":"Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer is a phase 3 interventional study registered as NCT07262567, led by Genfleet Therapeutics (Shanghai), and recruiting on the registry. Official title: A Multicenter, Open-Label, Randomised Controlled Phase III Study to Compare the Efficacy and Safety/Tolerability of GFH375 Monotherapy Versus Investigator's Choice of Chemotherapy in Patients With Previously Treated KRAS G12D-Mutant Metastatic Pancreatic Cancer. Planned enrolment is 320 participants (estimated). The study started in 2025-12-04 and primary completion is expected in 2027-06. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07262567","url":"https://clinicaltrials.gov/study/NCT07262567"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["gfh375","tegafur-gimeracil-oteracil"],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07262567","phase":"3","setting":"A Multicenter, Open-Label, Randomized Controlled Phase III Study to Compare the Efficacy and Safety/Tolerability of GFH375 Monotherapy Versus Investigator's Choice of Chemotherapy in Patients With Previously Treated KRAS G12D-Mutant Metastatic Pancreatic Cancer","sponsor":"Genfleet Therapeutics (Shanghai)","started":"2025-12-04","startedType":"actual","enrolled":320,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03016819","kind":"trial","name":"Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)","aka":["APROMISS"],"tldr":"A phase 3 trial of Anlotinib, Dacarbazine in sarcomas, run by Advenchen Laboratories, LLC, now recruiting.","summary":"Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS) is a phase 3 interventional study registered as NCT03016819 by Advenchen Laboratories, LLC, with 325 participants planned, started 2017-08-15 and due to reach its primary completion in 2027-12. Interventions recorded: AL3818, Dacarbazine, AL3818 or placebo, Midazolam 2 mg for CYP3A4 phenotyping, Digoxin (0.25mg). Conditions listed: Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma, Soft-Tissue Sarcoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03016819","url":"https://clinicaltrials.gov/study/NCT03016819"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sarcoma","alveolar-soft-part-sarcoma","leiomyosarcoma","synovial-sarcoma"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["anlotinib","dacarbazine"],"companies":["advenchen-laboratories"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03016819","phase":"3","setting":"A Phase III Study of AL3818 (Anlotinib, Catequentinib) Hydrochloride Monotherapy in Subjects With Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma","sponsor":"Advenchen Laboratories, LLC","started":"2017-08-15","startedType":"actual","enrolled":325,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06889688","kind":"trial","name":"Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 3 trial of camrelizumab, rivoceranib (apatinib) and eribulin in triple-negative breast cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, now recruiting.","summary":"Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer is a phase 3, randomised interventional study registered as NCT06889688 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, with a registry enrolment figure of 246 participants, started 2025-02-21 and due to reach its primary completion in 2028-12-31. Interventions recorded: Camrelizumab+Apatinib+Eribulin; Physician's choice chemotherapy. Conditions listed: Breast Cancer Stage IV; Triple -Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Pathologically confirmed advanced triple-negative breast cancer (TNBC), defined as ER-negative (IHC ER-positive percentage \\<1%), PR-negative (IHC PR-positive percentage \\<1%), and HER2-negative (IHC-/+, or IHC++ but FISH/CISH-), with at least one measurable lesion per RECIST v1\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06889688","url":"https://clinicaltrials.gov/study/NCT06889688"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["camrelizumab","rivoceranib","eribulin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06889688","phase":"3","setting":"A Multicenter, Phase III, Randomized Controlled Trial Comparing Camrelizumab Plus Apatinib and Eribulin Versus Physician's Choice Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","started":"2025-02-21","startedType":"actual","enrolled":246,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06927986","kind":"trial","name":"Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC（SYNSTAR01）","aka":["SYNSTAR01"],"tldr":"A phase 3 trial testing SYS6010 in non-small-cell lung cancer, now recruiting.","summary":"Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC（SYNSTAR01） is a phase 3 interventional study registered as NCT06927986, led by CSPC Megalith Biopharmaceutical, and recruiting on the registry. Official title: A Randomised, Open-label, Multi-centre, Phase III Clinical Study Comparing SYS6010 With Platinum-based Chemotherapy in the Treatment of EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of EGFR TKI Treatment. Planned enrolment is 380 participants (estimated). The study started in 2025-03-30 and primary completion is expected in 2026-07-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06927986","url":"https://clinicaltrials.gov/study/NCT06927986"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["sys6010"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06927986","phase":"3","setting":"A Randomized, Open-label, Multi-center, Phase III Clinical Study Comparing SYS6010 With Platinum-based Chemotherapy in the Treatment of EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of EGFR TKI Treatment","sponsor":"CSPC Megalith Biopharmaceutical","started":"2025-03-30","startedType":"actual","enrolled":380,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06350097","kind":"trial","name":"Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell L","aka":["TROPION-Lung14"],"tldr":"A phase 3 trial of Osimertinib, Datopotamab deruxtecan in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, now recruiting.","summary":"Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT06350097 by AstraZeneca, with 582 participants planned, started 2024-04-29 and due to reach its primary completion in 2028-03-21. Interventions recorded: Osimertinib, Datopotamab Deruxtecan. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06350097","url":"https://clinicaltrials.gov/study/NCT06350097"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["adc","kinase-inhibitors","topoisomerase-inhibitors"],"targets":[],"drugs":["osimertinib","datopotamab-deruxtecan"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06350097","phase":"3","setting":"A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"AstraZeneca","started":"2024-04-29","startedType":"actual","enrolled":582,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05687266","kind":"trial","name":"Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations","aka":["AVANZAR"],"tldr":"A phase 3 trial of Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin and Pemetrexed in non-small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations is a phase 3 interventional study registered as NCT05687266 by AstraZeneca, with 1350 participants enrolled, started 2022-12-29 and due to reach its primary completion in 2027-11-01. Interventions recorded: Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin and Pemetrexed.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05687266","url":"https://clinicaltrials.gov/study/NCT05687266"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["adc","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan","durvalumab","carboplatin","pembrolizumab","cisplatin","pemetrexed"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05687266","phase":"3","setting":"A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR)","sponsor":"AstraZeneca","started":"2022-12-29","startedType":"actual","enrolled":1350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06357533","kind":"trial","name":"Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥","aka":["TROPION-Lung10"],"tldr":"A phase 3 trial of Datopotamab deruxtecan, Rilvegostomig, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, now recruiting.","summary":"Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations is a phase 3 interventional study registered as NCT06357533 by AstraZeneca, with 675 participants planned, started 2024-04-11 and due to reach its primary completion in 2029-12-28. Interventions recorded: Datopotamab Deruxtecan, Rilvegostomig, Pembrolizumab. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06357533","url":"https://clinicaltrials.gov/study/NCT06357533"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pdl1-high-nsclc"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan","rilvegostomig","pembrolizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06357533","phase":"3","setting":"A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)","sponsor":"AstraZeneca","started":"2024-04-11","startedType":"actual","enrolled":675,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06632912","kind":"trial","name":"Phase IIIb Clinical Trial of Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) for Age/Immunization Schedule Bridging","aka":[],"tldr":"A phase 3 trial of 2 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in advanced solid tumours, run by National Vaccine and Serum Institute, China, active and no longer recruiting.","summary":"Phase IIIb Clinical Trial of Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) for Age/Immunization Schedule Bridging is a phase 3 interventional study registered as NCT06632912 by National Vaccine and Serum Institute, China, with 1800 participants enrolled, started 2025-11-21 and due to reach its primary completion in 2032-07. Interventions recorded: 2 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) and 3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06632912","url":"https://clinicaltrials.gov/study/NCT06632912"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06632912","phase":"3","setting":"A Randomized, Open-label, Non-inferiority Phase IIIb Clinical Trial to Evaluate the Immunogenicity Age/Schedule Bridging Between Adolescent Girls Aged 9-14 Years Receiving a 2-dose Regimen or Adolescent Girls Aged 9-17 Years Receiving a 3-dose Regimen of a Quadrivalent Recombinant Human Papillomavirus (HPV) Vaccine (Hansenula Polymorpha) and Women Aged 18-35 Years.","sponsor":"National Vaccine and Serum Institute, China","started":"2025-11-21","startedType":"actual","enrolled":1800,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05827081","kind":"trial","name":"Phase IIIb Study of Ribociclib + ET in Early Breast Cancer","aka":[],"tldr":"A phase 3 trial of Ribociclib and Exemestane in advanced solid tumours, run by Novartis Pharmaceuticals, now recruiting.","summary":"Phase IIIb Study of Ribociclib + ET in Early Breast Cancer is a phase 3 interventional study registered as NCT05827081 by Novartis Pharmaceuticals, with 1400 participants planned, started 2024-02-28 and due to reach its primary completion in 2029-09-07. Interventions recorded: Ribociclib, Letrozole, Ansastrozole, Goserelin, Leuprolide and Exemestane.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05827081","url":"https://clinicaltrials.gov/study/NCT05827081"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["ribociclib","exemestane"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05827081","phase":"3","setting":"A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)","sponsor":"Novartis Pharmaceuticals","started":"2024-02-28","startedType":"actual","enrolled":1400,"enrolledBasis":"registry","outcomes":[]},{"id":"phergain","kind":"trial","name":"PHERGain","aka":[],"tldr":"Using an early PET scan to spot responders let a third of women be cured of HER2-positive breast cancer without any chemotherapy.","summary":"PET responders after 2 cycles continued antibodies alone; those achieving pCR (37.9% of the arm) skipped chemotherapy entirely. 3-year iDFS 95.4% in the PET-adapted arm, meeting its co-primary endpoint. Discussed at ESMO Breast 2026 as the model for imaging-guided de-escalation; a phase 3 (PHERGain-2) is underway.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03161353","url":"https://clinicaltrials.gov/study/NCT03161353"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["fdg-pet"],"targets":[],"drugs":["trastuzumab","pertuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":["pcr"],"trials":[],"people":["aleix-prat","javier-cortes"],"bottlenecks":[],"keyPapers":["paper-phergain-lancet-oncol-2021","paper-phergain-lancet-2024-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03161353","phase":"2","setting":"HER2+ early breast cancer: chemotherapy-free trastuzumab + pertuzumab with early 18F-FDG PET response assessment to decide whether chemotherapy is needed","sponsor":"MEDSIR","result":"3-year iDFS 95.4% in the PET-adapted arm; ~1 in 3 spared chemotherapy.","started":"2017-06-26","startedType":"actual","yearReported":2024,"enrolled":377,"enrolledBasis":"registry","outcomes":[{"endpoint":"3-year invasive disease-free survival (PET-adapted arm)","primary":true,"unit":"%","arms":[{"name":"PET-adapted HP ± chemotherapy","n":285,"value":95.4}],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00054-0/fulltext"}],"replication":"Consistent with WSG-ADAPT HER2+/HR- (pCR-guided de-escalation); phase 3 confirmation pending."},{"id":"nct00248287","kind":"trial","name":"PhII ICb With/Without Erbitux in MBC Pts","aka":[],"tldr":"A phase 2 trial of Carboplatin and Cetuximab in advanced solid tumours, run by US Oncology Research, active and no longer recruiting.","summary":"PhII ICb With/Without Erbitux in MBC Pts is a phase 2 interventional study registered as NCT00248287 by US Oncology Research, with 154 participants enrolled, started 2005-07-28 and due to reach its primary completion in 2025-12. Interventions recorded: Irinotecan + Carboplatin and irinotecan + Carboplatin + erbitux. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00248287","url":"https://clinicaltrials.gov/study/NCT00248287"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["carboplatin","cetuximab"],"companies":["mckesson-us-oncology","bms","pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00248287","phase":"2","setting":"Randomized Phase II Study of Weekly Irinotecan/Carboplatin (ICb) With or Without Cetuximab (Erbitux) in Patients With Metastatic Breast Cancer","sponsor":"US Oncology Research","started":"2005-07-28","startedType":"actual","yearReported":2016,"enrolled":154,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rates (ORR)","primary":true,"unit":"%","arms":[{"name":"Irinotecan+Carboplatin","n":66,"value":36.4,"note":"95% CI 24.9 to 49.1; Figures from the ClinicalTrials.gov results section (first posted 2016-11-03), not from a publication"},{"name":"Irinotecan+Carboplatin+Cetuximab","n":71,"value":36.6,"note":"95% CI 25.5 to 48.9"}],"source":"https://clinicaltrials.gov/study/NCT00248287?tab=results"},{"endpoint":"Median Overall Survival (OS)","unit":"months","arms":[{"name":"Irinotecan+Carboplatin","n":75,"value":12.5,"note":"95% CI 10.6 to 17.1; Figures from the ClinicalTrials.gov results section (first posted 2016-11-03), not from a publication"},{"name":"Irinotecan+Carboplatin+Cetuximab","n":79,"value":14.6,"note":"95% CI 10.4 to 16.9"}],"source":"https://clinicaltrials.gov/study/NCT00248287?tab=results"},{"endpoint":"Median Time of Progression-free Survival (PFS)","unit":"months","arms":[{"name":"Irinotecan+Carboplatin","n":75,"value":4.4,"note":"95% CI 3.2 to 5.8; Figures from the ClinicalTrials.gov results section (first posted 2016-11-03), not from a publication"},{"name":"Irinotecan+Carboplatin+Cetuximab","n":79,"value":4.6,"note":"95% CI 3.5 to 5.5"}],"source":"https://clinicaltrials.gov/study/NCT00248287?tab=results"}]},{"id":"phoenix","kind":"trial","name":"PHOENIX DDR/Anti-PD-L1","aka":["PHOENIX"],"tldr":"PHOENIX, a UK trial from the Institute of Cancer Research, gives women whose triple-negative breast cancer has not responded fully to pre-operative chemotherapy a short course of a DNA-repair drug (olaparib or ceralasertib) or immunotherapy (durvalumab) before surgery, and measures what it does to the tumour, to find which patients could benefit from these drugs after surgery.","summary":"PHOENIX (NCT03740893) is a non-randomised, biomarker-driven phase 2 window-of-opportunity and adjuvant study for 119 patients with neoadjuvant-treatment-resistant residual triple-negative breast cancer, run by the Institute of Cancer Research with AstraZeneca. Cohorts receive olaparib, the ATR inhibitor ceralasertib (AZD6738) or durvalumab between the end of neoadjuvant chemotherapy and surgery, with paired biopsies; co-primary endpoints are the change in Ki67 proliferation index and in proliferation gene expression for the DNA damage response cohorts, the change in CD8-positive stromal TILs and the interferon-gamma signature for the durvalumab cohort, and plasma ctDNA change for the later cohorts. It opened in October 2019 with primary completion expected in December 2026. No results were indexed in September 2026.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03740893","url":"https://clinicaltrials.gov/study/NCT03740893"}],"tags":[],"related":["lymphoma-roadmap","arched","paper-phoenix-ibrutinib-r-chop-non-gcb-dlbcl-jco-2019"],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["parp-inhibitor","checkpoint-inhibitor"],"targets":["atr","parp","pdl1"],"drugs":["olaparib","ceralasertib","durvalumab"],"companies":["astrazeneca"],"institutions":["cruk"],"pathways":[],"terms":["rcb","tils","ctdna","tnbc-residual-disease-decision"],"trials":["keynote-522","partner"],"people":[],"bottlenecks":[],"keyPapers":["paper-phoenix-ibrutinib-r-chop-non-gcb-dlbcl-jco-2019"],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 6): Royal Bournemouth Hospital, King's College Hospital London, Christie Hospital Manchester, Velindre Cancer Centre Cardiff, Guy's and St Thomas' Hospital London, Weston Park Hospital Sheffield."],"nct":"NCT03740893","phase":"2","setting":"Triple-negative breast cancer with residual disease after neoadjuvant chemotherapy: a pre-surgical window of olaparib, the ATR inhibitor ceralasertib or durvalumab, then post-surgical adjuvant treatment, biomarker-driven, six UK hospitals","sponsor":"Institute of Cancer Research, United Kingdom, with AstraZeneca","started":"2019-10-15","startedType":"actual","enrolled":119,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07619898","kind":"trial","name":"PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and/or Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure","aka":[],"tldr":"A phase 2 trial of Methoxsalen in Skin cancer and Melanoma, run by Therakos LLC, not yet recruiting.","summary":"PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and/or Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure is a phase 2 interventional study registered as NCT07619898 by Therakos LLC, with 112 participants planned, started 2026-07 and due to reach its primary completion in 2028-12. Interventions recorded: methoxsalen, Extracorporeal photopheresis (ECP), Vedolizumab, Infliximab, Mycophenolate Mofetil (MMF), Azathioprine. Conditions recorded: Colitis, Hepatitis, Melanoma (Skin Cancer).\n\nLinked to the drug Methoxsalen because the registry names it among its interventions and Skin cancer and Melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07619898","url":"https://clinicaltrials.gov/study/NCT07619898"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["skin-cancer","melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["methoxsalen-ecp"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07619898","phase":"2","setting":"PHOENIX- A Phase 2, Randomized, Controlled, Open-label, Multicenter Study to Evaluate the Efficacy and Safety/Tolerability of Extracorporeal Photopheresis (ECP) Versus Best Available Therapy (BAT) for the Treatment of Immune-related Colitis or Hepatitis With Inadequate Response to Corticosteroids in Participants With Unresectable or Metastatic Melanoma Treated With Immune Checkpoint Inhibitors (ICI)","sponsor":"Therakos LLC","started":"2026-07","startedType":"estimated","enrolled":112,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07416058","kind":"trial","name":"PHOENIX: QL1706 Plus Chemotherapy and Bevacizumab in AGA-Resistant, PD-L1 ≥50% Non-Squamous NSCLC","aka":["PHOENIX"],"tldr":"A phase 2 trial of iparomlimab and tuvonralimab in lung cancer, run by Guangdong Association of Clinical Trials, not yet recruiting.","summary":"PHOENIX: QL1706 Plus Chemotherapy and Bevacizumab in AGA-Resistant, PD-L1 ≥50% Non-Squamous NSCLC is a phase 2, interventional study registered as NCT07416058 by Guangdong Association of Clinical Trials, with a registry enrolment figure of 61 participants, started 2026-01-31 and due to reach its primary completion in 2027-12-31. Interventions recorded: QL1706 (bispecific antibody targeting PD-1 and CLTA-4). Conditions listed: Lung Adenocarcinoma. Primary outcome: Objective Response Rate (ORR) per RECIST 1.1. Lung eligibility wording from the registry: \"The study will enroll adult patients (aged 18-75 years) with histologically confirmed locally advanced or metastatic NSCLC (AJCC 9th Edition, Stage IIIB-IVB), and harbor confirmed actionable driver mutations for which targeted therapies are available; these mutations are stratified as follows: EGFR \". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07416058","url":"https://clinicaltrials.gov/study/NCT07416058"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-adenocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["iparomlimab-tuvonralimab"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07416058","phase":"2","setting":"A Multicenter Study of Iparomlimab and Tuvonralimab (QL1706) Plus Platinum-Based Doublet Chemotherapy and Bevacizumab in PD-L1 ≥50% Non-Squamous Non-Small Cell Lung Cancer With Actionable Genomic Alterations (AGA) Resistant to Prior Targeted Therapy","sponsor":"Guangdong Association of Clinical Trials","started":"2026-01-31","startedType":"estimated","enrolled":61,"enrolledBasis":"registry","outcomes":[]},{"id":"mal-pdt-versus-cryotherapy-superficial-bcc","kind":"trial","name":"Photodynamic therapy against cryotherapy for superficial basal cell carcinoma","aka":["Basset-Seguin trial","MAL-PDT versus cryotherapy in superficial basal cell carcinoma"],"tldr":"Freezing a thin basal cell carcinoma with liquid nitrogen and treating it with light gave the same number of recurrences five years later. What separated them was how the skin looked afterwards, and light was much better.","summary":"Cryotherapy is the oldest and cheapest of the destructive treatments and the one most often done in a general practice or a minor operations clinic. This multicentre randomised trial compared it against methyl aminolevulinate photodynamic therapy in primary superficial basal cell carcinoma: 60 patients with 114 lesions were given one session of photodynamic therapy and 58 patients with 105 lesions had cryotherapy with two freeze-thaw cycles, with re-treatment of incomplete responders at three months.\n\nOne hundred lesions treated with photodynamic therapy and 93 treated with cryotherapy were in complete response at three months after the last treatment and could be followed for recurrence. Over five years there was no difference in recurrence: 20 per cent after cryotherapy against 22 per cent after photodynamic therapy, p=0.86.\n\nThe difference was in the skin. An excellent cosmetic outcome was recorded in 60 per cent of the photodynamic therapy group against 16 per cent of the cryotherapy group, p=0.00078. Cryotherapy leaves a pale, often depressed scar with a permanent loss of pigment, which on a face is exactly what a person notices. Both results, the equality of recurrence and the inequality of appearance, matter: this is a trial in which the cheap old treatment holds its own on the outcome the doctor measures and loses on the outcome the patient sees.","status":"mixed","asOf":"2026-09-25","links":[{"label":"Basset-Seguin et al., five-year randomised comparison (European Journal of Dermatology 2008; its digital object identifier 10.1684/ejd.2008.0472 does not resolve, so this is the working address)","url":"https://pubmed.ncbi.nlm.nih.gov/18693158/"}],"tags":[],"related":[],"cancers":["basal-cell-carcinoma","skin-cancer"],"sections":[],"technologies":["photodynamic-therapy-lasers","cryoablation"],"targets":[],"drugs":["methyl-aminolevulinate"],"companies":[],"institutions":[],"pathways":[],"terms":["topical-and-destructive-treatment-bcc"],"trials":["mal-pdt-versus-surgery-nodular-bcc","mal-pdt-imiquimod-fluorouracil-superficial-bcc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Primary superficial basal cell carcinoma: methyl aminolevulinate photodynamic therapy in one session against cryotherapy with two freeze-thaw cycles, with re-treatment of incomplete responders and lesion recurrence over five years","sponsor":"Photocure and Galderma, run in European dermatology centres","result":"Five-year recurrence 20 per cent after cryotherapy against 22 per cent after methyl aminolevulinate photodynamic therapy (p=0.86), with an excellent cosmetic outcome in 16 against 60 per cent (p=0.00078).","yearReported":2008,"enrolled":118,"enrolledBasis":"randomised","enrolledNote":"60 patients with 114 lesions were randomised to photodynamic therapy and 58 with 105 lesions to cryotherapy, 118 patients in all; the trial ran before trial registration was required and has no registry record.","outcomes":[{"endpoint":"Lesion recurrence at 5 years","primary":true,"unit":"%","arms":[{"name":"Cryotherapy, two freeze-thaw cycles","n":93,"value":20},{"name":"Methyl aminolevulinate photodynamic therapy","n":100,"value":22}],"p":"0.86","source":"https://pubmed.ncbi.nlm.nih.gov/18693158/"},{"endpoint":"Excellent cosmetic outcome","unit":"%","arms":[{"name":"Cryotherapy, two freeze-thaw cycles","value":16},{"name":"Methyl aminolevulinate photodynamic therapy","value":60}],"p":"0.00078","source":"https://pubmed.ncbi.nlm.nih.gov/18693158/"}],"replication":"The Dutch three-arm trial did not include cryotherapy, so there is no head-to-head evidence placing cryotherapy against imiquimod or fluorouracil; the comparison people make in clinic rests on this trial and on the separate photodynamic therapy comparisons."},{"id":"mal-pdt-imiquimod-fluorouracil-superficial-bcc","kind":"trial","name":"Photodynamic therapy against imiquimod against fluorouracil for superficial basal cell carcinoma","aka":["Arits trial","Dutch superficial basal cell carcinoma trial","MAL-PDT versus imiquimod versus fluorouracil"],"tldr":"This trial compared the three non-surgical treatments people are actually offered for a thin basal cell carcinoma. Photodynamic therapy, the one that was assumed to be best, came last. The imiquimod cream was the best of the three at one year and still the best at five, though by then a fifth of those treated with it had the tumour back.","summary":"Seven Dutch hospitals randomised 601 patients with a histologically proven superficial basal cell carcinoma to methyl aminolevulinate photodynamic therapy, imiquimod cream or fluorouracil cream between 2008 and 2010, with a single blinded observer. Photodynamic therapy was the assumed best treatment and was made the comparator; the trial tested whether the two creams were non-inferior to it within 10 per cent.\n\nAt twelve months the proportion free of tumour at both three and twelve months was 72.8 per cent for photodynamic therapy (95 per cent confidence interval 66.8 to 79.4), 83.4 per cent for imiquimod (78.2 to 88.9) and 80.1 per cent for fluorouracil (74.7 to 85.9). Fluorouracil was non-inferior and imiquimod was superior: the difference against photodynamic therapy was 10.6 percentage points for imiquimod (1.5 to 19.5, p=0.021) and 7.3 points for fluorouracil (-1.9 to 16.5, p=0.120).\n\nThe five-year report is the one to quote, because it separates the two creams from each other. Tumour-free survival at five years was 62.7 per cent after photodynamic therapy (55.3 to 69.2), 80.5 per cent after imiquimod (74.0 to 85.6) and 70.0 per cent after fluorouracil (62.9 to 76.0). Against photodynamic therapy the hazard ratio for treatment failure was 0.48 for imiquimod (0.32 to 0.71, p<0.001) and 0.74 for fluorouracil (0.53 to 1.05, p=0.09); imiquimod also beat fluorouracil, hazard ratio 0.65 (0.43 to 0.98, p=0.04).\n\nThe side effects differ in kind rather than in amount. Moderate to severe pain and burning were reported during the photodynamic therapy session itself; the creams caused swelling, erosion, crusting and itching over weeks. In a separate analysis alongside the trial, twelve-month costs were 680 euros for photodynamic therapy, 526 for imiquimod and 388 for fluorouracil, so the most expensive treatment was also the least effective.","status":"positive","asOf":"2026-09-25","links":[{"label":"ISRCTN79701845","url":"https://www.isrctn.com/ISRCTN79701845"},{"label":"One-year results (Lancet Oncology 2013)","url":"https://doi.org/10.1016/S1470-2045(13)70143-8"},{"label":"Five-year results (Journal of Investigative Dermatology 2018)","url":"https://doi.org/10.1016/j.jid.2017.09.033"},{"label":"Five-year results on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/29045820/"}],"tags":[],"related":[],"cancers":["basal-cell-carcinoma","skin-cancer"],"sections":[],"technologies":["photodynamic-therapy-lasers"],"targets":[],"drugs":["imiquimod","fluorouracil","methyl-aminolevulinate"],"companies":[],"institutions":[],"pathways":[],"terms":["topical-and-destructive-treatment-bcc"],"trials":["sins-trial","mal-pdt-versus-surgery-nodular-bcc","mal-pdt-versus-cryotherapy-superficial-bcc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN79701845","phase":"3","setting":"Histologically proven primary superficial basal cell carcinoma: methyl aminolevulinate photodynamic therapy in two sessions a week apart, against imiquimod 5 per cent cream once daily five days a week for six weeks, against fluorouracil 5 per cent cream twice daily for four weeks, with freedom from tumour at both three and twelve months as the primary outcome and a non-inferiority margin of 10 per cent","sponsor":"Maastricht University Medical Centre, funded by the Netherlands Organisation for Health Research and Development (ZonMw), which the trial report names as the Netherlands Organization for Scientific Research","result":"Tumour-free survival at five years 80.5 per cent with imiquimod, 70.0 per cent with fluorouracil and 62.7 per cent with methyl aminolevulinate photodynamic therapy; imiquimod beat both (hazard ratio 0.48 against photodynamic therapy and 0.65 against fluorouracil).","yearReported":2018,"enrolled":601,"enrolledBasis":"randomised","enrolledNote":"601 patients were randomised at seven Dutch hospitals: 202 to photodynamic therapy, 198 to imiquimod and 201 to fluorouracil. The ISRCTN record gives a target of 600 and a final enrolment of 601, and registers recruitment as running from 1 March 2008 to 1 March 2011.","outcomes":[{"endpoint":"Tumour-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Imiquimod 5 per cent cream","value":80.5,"note":"95 per cent confidence interval 74.0 to 85.6"},{"name":"Fluorouracil 5 per cent cream","value":70,"note":"95 per cent confidence interval 62.9 to 76.0"},{"name":"Methyl aminolevulinate photodynamic therapy","value":62.7,"note":"95 per cent confidence interval 55.3 to 69.2"}],"source":"https://doi.org/10.1016/j.jid.2017.09.033"},{"endpoint":"Free of tumour at both 3 and 12 months","primary":true,"unit":"%","arms":[{"name":"Imiquimod 5 per cent cream","n":189,"value":83.4,"note":"95 per cent confidence interval 78.2 to 88.9"},{"name":"Fluorouracil 5 per cent cream","n":198,"value":80.1,"note":"95 per cent confidence interval 74.7 to 85.9"},{"name":"Methyl aminolevulinate photodynamic therapy","n":196,"value":72.8,"note":"95 per cent confidence interval 66.8 to 79.4"}],"source":"https://doi.org/10.1016/s1470-2045(13)70143-8"},{"endpoint":"Hazard ratio for treatment failure at 5 years against photodynamic therapy","unit":"hazard ratio","arms":[{"name":"Imiquimod 5 per cent cream","value":0.48,"note":"95 per cent confidence interval 0.32 to 0.71, p<0.001"},{"name":"Fluorouracil 5 per cent cream","value":0.74,"note":"95 per cent confidence interval 0.53 to 1.05, p=0.09"}],"source":"https://doi.org/10.1016/j.jid.2017.09.033"}],"replication":"SINS reached the same conclusion about imiquimod from the other direction, comparing it with surgery rather than with the other non-surgical options, and found it inferior to the operation."},{"id":"mal-pdt-versus-surgery-nodular-bcc","kind":"trial","name":"Photodynamic therapy against surgery for nodular basal cell carcinoma","aka":["Rhodes trial","MAL-PDT versus excision surgery in nodular basal cell carcinoma"],"tldr":"For the thicker, lump-like basal cell carcinoma, light treatment clears about as many at three months as surgery does, but over five years three times as many come back. What it buys is a better-looking result, and that is the whole of the trade.","summary":"Photodynamic therapy was being used for nodular basal cell carcinoma without randomised evidence, so this trial was built to supply some. European university dermatology departments randomised 101 adults with previously untreated nodular basal cell carcinoma to methyl aminolevulinate photodynamic therapy, given twice a week apart with red light at 75 J per square centimetre, or to simple excision.\n\nThe short-term result flattered the light. Complete response at three months was 48 of 53 lesions (91 per cent) with photodynamic therapy against 51 of 52 (98 per cent), a difference of 4.8 percentage points (-3.4 to 13.0, p=0.25), and thirteen patients with an incomplete response were re-treated. Five years of follow-up settled it: recurrence occurred in 7 of 49 lesions (14 per cent, 95 per cent confidence interval 6 to 27) after photodynamic therapy against 2 of 52 (4 per cent, 1 to 13), p=0.09, and the estimated sustained complete response rate was 76 per cent (59 to 87) against 96 per cent (84 to 99), p=0.01.\n\nWhat photodynamic therapy bought was appearance, and the difference is large: 27 of 31 patients (87 per cent, 70 to 96) had an excellent or good cosmetic outcome after light against 19 of 35 (54 per cent, 37 to 71) after surgery, p=0.007. That is the honest shape of every non-surgical option in this disease. It is not a cure rate argument, it is a scar argument, and the person whose tumour is on the tip of the nose is entitled to weigh it.","status":"negative","asOf":"2026-09-25","links":[{"label":"One-year results (Archives of Dermatology 2004)","url":"https://doi.org/10.1001/archderm.140.1.17"},{"label":"Five-year follow-up (Archives of Dermatology 2007)","url":"https://doi.org/10.1001/archderm.143.9.1131"},{"label":"Five-year follow-up on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/17875873/"},{"label":"Ten-year three-arm replication (Photodiagnosis and Photodynamic Therapy 2025)","url":"https://doi.org/10.1016/j.pdpdt.2025.104702"}],"tags":[],"related":[],"cancers":["basal-cell-carcinoma","skin-cancer"],"sections":[],"technologies":["photodynamic-therapy-lasers"],"targets":[],"drugs":["methyl-aminolevulinate"],"companies":[],"institutions":[],"pathways":[],"terms":["topical-and-destructive-treatment-bcc"],"trials":["mal-pdt-imiquimod-fluorouracil-superficial-bcc","mal-pdt-versus-cryotherapy-superficial-bcc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Previously untreated nodular basal cell carcinoma: methyl aminolevulinate photodynamic therapy given twice a week apart against simple excision surgery, with clinical clearance at three months as the primary endpoint and recurrence and cosmetic outcome to five years","sponsor":"Photocure and Galderma, run in European university dermatology departments","result":"Five-year recurrence 14 per cent after methyl aminolevulinate photodynamic therapy against 4 per cent after excision (sustained complete response 76 against 96 per cent, p=0.01), with an excellent or good cosmetic outcome in 87 against 54 per cent.","yearReported":2007,"enrolled":101,"enrolledBasis":"randomised","enrolledNote":"101 adults with previously untreated nodular basal cell carcinoma were randomised, 52 to photodynamic therapy and 49 to surgery; the trial ran before trial registration was required and has no registry record.","outcomes":[{"endpoint":"Lesion recurrence at 5 years","primary":true,"unit":"%","arms":[{"name":"Methyl aminolevulinate photodynamic therapy","n":49,"value":14,"note":"7 of 49 lesions; 95 per cent confidence interval 6 to 27"},{"name":"Excision surgery","n":52,"value":4,"note":"2 of 52 lesions; 95 per cent confidence interval 1 to 13"}],"p":"0.09","source":"https://doi.org/10.1001/archderm.143.9.1131"},{"endpoint":"Sustained lesion complete response at 5 years","unit":"%","arms":[{"name":"Methyl aminolevulinate photodynamic therapy","value":76,"note":"95 per cent confidence interval 59 to 87"},{"name":"Excision surgery","value":96,"note":"95 per cent confidence interval 84 to 99"}],"p":"0.01","source":"https://doi.org/10.1001/archderm.143.9.1131"},{"endpoint":"Excellent or good cosmetic outcome at 5 years","unit":"%","arms":[{"name":"Methyl aminolevulinate photodynamic therapy","n":31,"value":87,"note":"27 of 31 patients; 95 per cent confidence interval 70 to 96"},{"name":"Excision surgery","n":35,"value":54,"note":"19 of 35 patients; 95 per cent confidence interval 37 to 71"}],"p":"0.007","source":"https://doi.org/10.1001/archderm.143.9.1131"}],"replication":"A Brazilian three-arm randomised trial of 567 small nodular basal cell carcinomas with ten years of follow-up found the same ordering: recurrence-free survival at ten years of 92.8 per cent after surgery, 74.5 per cent after aminolevulinic acid photodynamic therapy and 69 per cent after methyl aminolevulinate photodynamic therapy."},{"id":"nct06807359","kind":"trial","name":"Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System","aka":[],"tldr":"A phase 1/2 trial of Photodynamic Therapy (PDT) in prostate cancer, run by SpectraCure AB, now recruiting.","summary":"Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System is a phase 1/2 interventional study registered as NCT06807359 by SpectraCure AB, with 43 participants planned, started 2025-01-06 and due to reach its primary completion in 2028-01. Interventions recorded: Photodynamic Therapy (PDT) and Verteporfin Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06807359","url":"https://clinicaltrials.gov/study/NCT06807359"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["spectracure"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06807359","phase":"1/2","setting":"Open-label Clinical Phase 1/2 Study to Assess the Safety and Efficacy of the SpectraCure P18 System and Verteporfin for Injection for the Treatment of Primary Localized Prostate Cancer","sponsor":"SpectraCure AB","started":"2025-01-06","startedType":"actual","enrolled":43,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06519266","kind":"trial","name":"PHP in Combination With IPI1/NIVO3 Compared to IPI3/NIVO1 Only in Patients With Uveal Melanoma Liver Metastases","aka":["SCANDIUM-III"],"tldr":"A phase 3 trial of Percutaneous hepatic perfusion in Uveal melanoma, run by Vastra Gotaland Region, now recruiting.","summary":"PHP in Combination With IPI1/NIVO3 Compared to IPI3/NIVO1 Only in Patients With Uveal Melanoma Liver Metastases is a phase 3 interventional study registered as NCT06519266 by Vastra Gotaland Region, with 40 participants planned, started 2024-06-10 and due to reach its primary completion in 2028-12-31. Interventions recorded: PHP, IPI1/NIVO3, IPI3/NIVO1. Conditions recorded: Uveal Melanoma, Liver Metastases.\n\nLinked to the technology Percutaneous hepatic perfusion because the registry's title names it (\"percutaneous hepatic perfusion\") and Uveal melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06519266","url":"https://clinicaltrials.gov/study/NCT06519266"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["uveal-melanoma"],"sections":[],"technologies":["percutaneous-hepatic-perfusion"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06519266","phase":"3","setting":"A Phase III Randomized Controlled Multicentre Trial of Percutaneous Hepatic Perfusion in Combination With Ipilimumab and Nivolumab Compared to Ipilimumab and Nivolumab Only in Patients With Uveal Melanoma Liver Metastases","sponsor":"Vastra Gotaland Region","started":"2024-06-10","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06731894","kind":"trial","name":"Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors","aka":[],"tldr":"A phase 2 trial of Dronabinol in Breast cancer, run by City of Hope Medical Center, now recruiting.","summary":"Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors is a phase 2 interventional study registered as NCT06731894 by City of Hope Medical Center, with 120 participants planned, started 2025-10-03 and due to reach its primary completion in 2028-01-07. Interventions recorded: Biospecimen Collection, Cannabidiol, Dronabinol, Placebo Administration, Survey Administration. Conditions recorded: Breast Carcinoma, Chemotherapy-Induced Peripheral Neuropathy, Colon Carcinoma.\n\nLinked to the drug Dronabinol because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06731894","url":"https://clinicaltrials.gov/study/NCT06731894"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["dronabinol"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06731894","phase":"2","setting":"A Pilot Study to Evaluate the Benefits of Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy","sponsor":"City of Hope Medical Center","started":"2025-10-03","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00003139","kind":"trial","name":"Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer","aka":[],"tldr":"A phase 3 trial of Pilocarpine in Head and neck squamous cell carcinoma, run by Radiation Therapy Oncology Group, completed.","summary":"Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer is a phase 3 interventional study registered as NCT00003139 by Radiation Therapy Oncology Group, with 249 participants recorded, started 1998-03 and reaching its primary completion in 2001-01. Interventions recorded: pilocarpine hydrochloride, Placebo. Conditions recorded: Head and Neck Cancer, Oral Complications.\n\nLinked to the drug Pilocarpine because the registry names it among its interventions and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00003139","url":"https://clinicaltrials.gov/study/NCT00003139"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","oral-cavity-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pilocarpine"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003139","phase":"3","setting":"A Phase III Study to Test the Efficacy of the Prophylactic Use of Oral Pilocarpine to Reduce Hyposalivation and Mucositis Associated With Curative Radiation Therapy in Head and Neck Cancer Patients","sponsor":"Radiation Therapy Oncology Group","started":"1998-03","enrolled":249,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00343382","kind":"trial","name":"Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer","aka":[],"tldr":"A phase 3 trial of Pilocarpine in Breast cancer, run by Alliance for Clinical Trials in Oncology, completed.","summary":"Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer is a phase 3 interventional study registered as NCT00343382 by Alliance for Clinical Trials in Oncology, with 201 participants recorded, started 2006-12 and reaching its primary completion in 2009-07. Interventions recorded: pilocarpine hydrochloride, placebo. Conditions recorded: Breast Cancer, Vaginal Dryness.\n\nLinked to the drug Pilocarpine because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00343382","url":"https://clinicaltrials.gov/study/NCT00343382"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pilocarpine"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00343382","phase":"3","setting":"Pilocarpine for Vaginal Dryness: A Phase III Randomized, Double Blind, Placebo-Controlled Study","sponsor":"Alliance for Clinical Trials in Oncology","started":"2006-12","yearReported":2014,"enrolled":201,"enrolledBasis":"registry","outcomes":[{"endpoint":"Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics","primary":true,"unit":"units on a scale","arms":[{"name":"Collective Placebo","n":61,"value":63.6,"note":"SD 24.04; Figures from the ClinicalTrials.gov results section (first posted 2014-09-30), not from a publication"},{"name":"Pilocarpine 2 Times Per Day","n":61,"value":55.8,"note":"SD 27.69"},{"name":"Pilocarpine 4 Times Per Day","n":55,"value":66,"note":"SD 21.38"}],"source":"https://clinicaltrials.gov/study/NCT00343382?tab=results"}]},{"id":"nct00626444","kind":"trial","name":"Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL)","aka":[],"tldr":"A phase 2 trial of High-dose intravenous vitamin C in Non-Hodgkin lymphoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, recorded as terminated on the registry.","summary":"Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL) is a phase 2 interventional study registered as NCT00626444 by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, with 2 participants recorded, started 2008-02 and due to reach its primary completion in 2011-12. Interventions recorded: Intravenous vitamin C. Conditions recorded: Non-Hodgkin Lymphoma.\n\nLinked to the technology High-dose intravenous vitamin C because the registry's title names it (\"high dose intravenous vitamin c\") and Non-Hodgkin lymphoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00626444","url":"https://clinicaltrials.gov/study/NCT00626444"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":["high-dose-vitamin-c"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00626444","phase":"2","setting":"Phase II Trial of High Dose Intravenous Vitamin C in Patients With Refractory Non-Hodgkin Lymphoma","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University","started":"2008-02","enrolled":2,"enrolledBasis":"registry","outcomes":[]},{"id":"pivot","kind":"trial","name":"PIVOT (Prostate Cancer Intervention Versus Observation Trial)","aka":["PIVOT","Prostate Cancer Intervention Versus Observation Trial","CSP #407"],"tldr":"In men whose prostate cancer was found by a blood test, having the operation did not clearly help them live longer, and it left many more of them incontinent or unable to get an erection.","summary":"PIVOT randomised 731 men with localised prostate cancer, most of it detected by PSA testing, to radical prostatectomy or observation between November 1994 and January 2002, and followed them through August 2014.\n\nOver 19.5 years of follow-up (median 12.7 years), 223 of 364 men (61.3 percent) assigned surgery and 245 of 367 (66.8 percent) assigned observation died: absolute difference 5.5 percentage points (95 percent confidence interval -1.5 to 12.4), hazard ratio 0.84 (0.70 to 1.01), p=0.06. Death attributed to prostate cancer or its treatment occurred in 27 men (7.4 percent) after surgery and 42 (11.4 percent) under observation: absolute difference 4.0 percentage points (-0.2 to 8.3), hazard ratio 0.63 (0.39 to 1.02), p=0.06. Neither reached significance.\n\nThe subgroup signal was in intermediate-risk disease, where surgery was associated with an absolute reduction in all-cause mortality of 14.5 percentage points (2.8 to 25.6), against 0.7 points (-10.5 to 11.8) in low-risk and 2.3 points (-11.5 to 16.1) in high-risk disease (p=0.08 for interaction).\n\nWhat surgery reliably did was reduce treatment for progression, by 26.2 percentage points (19.0 to 32.9), almost all of it for asymptomatic local or PSA progression. What it reliably cost was continence and erections: urinary incontinence and erectile and sexual dysfunction were each more frequent after surgery through 10 years, and limitations in activities of daily living were greater through 2 years.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00007644","url":"https://clinicaltrials.gov/study/NCT00007644"},{"label":"PIVOT extended follow-up (New England Journal of Medicine 2017)","url":"https://doi.org/10.1056/NEJMoa1615869"}],"tags":[],"related":[],"cancers":["prostate","prostate-low-risk","prostate-intermediate-risk"],"sections":[],"technologies":["robotic-surgery","active-surveillance"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["prostatectomy","active-surveillance-term","psa","qol-pro"],"trials":["spcg-4","protect"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00007644","phase":"3","setting":"Localised prostate cancer, largely detected by PSA testing, in United States veterans: radical prostatectomy versus observation, with all-cause mortality as the primary outcome and prostate cancer mortality as the main secondary outcome, followed for nearly 20 years","sponsor":"United States Department of Veterans Affairs Cooperative Studies Program and the National Cancer Institute","result":"All-cause mortality 61.3 against 66.8 percent (hazard ratio 0.84, 95 percent confidence interval 0.70 to 1.01, p=0.06) and prostate cancer mortality 7.4 against 11.4 percent (0.63, 0.39 to 1.02, p=0.06); neither significant. Incontinence and erectile dysfunction were greater after surgery through 10 years.","started":"1994-11","yearReported":2017,"enrolled":731,"enrolledBasis":"randomised","enrolledNote":"731 men were randomised between November 1994 and January 2002; the ClinicalTrials.gov record for NCT00007644 gives the planned target rather than the analysed population.","outcomes":[{"endpoint":"Death from any cause (median 12.7 years)","primary":true,"unit":"%","arms":[{"name":"Radical prostatectomy","n":364,"value":61.3},{"name":"Observation","n":367,"value":66.8}],"hr":0.84,"ci":[0.7,1.01],"p":"0.06","source":"https://doi.org/10.1056/NEJMoa1615869"},{"endpoint":"Death from prostate cancer or its treatment","unit":"%","arms":[{"name":"Radical prostatectomy","n":364,"value":7.4},{"name":"Observation","n":367,"value":11.4}],"hr":0.63,"ci":[0.39,1.02],"p":"0.06","source":"https://doi.org/10.1056/NEJMoa1615869"}],"replication":"Consistent with ProtecT, which found prostate cancer mortality of 3.1, 2.2 and 2.9 percent at 15 years across monitoring, surgery and radiotherapy in a screen-detected population; SPCG-4, in clinically detected disease, found a clear survival benefit for surgery."},{"id":"nct07416994","kind":"trial","name":"Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial testing YL202 in non-small-cell lung cancer, now recruiting.","summary":"Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT07416994, led by MediLink Therapeutics (Suzhou), and recruiting on the registry. Official title: A Multicenter, Randomised, Open-label, Phase III Study to Compare the Efficacy and Safety of YL202 and Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer. Planned enrolment is 440 participants (estimated). The study started in 2026-03-18 and primary completion is expected in 2028-08-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07416994","url":"https://clinicaltrials.gov/study/NCT07416994"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["yl202"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07416994","phase":"3","setting":"A Multicenter, Randomized, Open-label, Phase III Study to Compare the Efficacy and Safety of YL202 and Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer","sponsor":"MediLink Therapeutics (Suzhou)","started":"2026-03-18","startedType":"actual","enrolled":440,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01086605","kind":"trial","name":"Pixantrone Dimaleate in Treating Patients With HER2-Negative Metastatic Breast Cancer","aka":[],"tldr":"A phase 2 trial of Pixantrone in Breast cancer, run by Alliance for Clinical Trials in Oncology, completed.","summary":"Pixantrone Dimaleate in Treating Patients With HER2-Negative Metastatic Breast Cancer is a phase 2 interventional study registered as NCT01086605 by Alliance for Clinical Trials in Oncology, with 46 participants recorded, started 2010-05 and reaching its primary completion in 2012-01. Interventions recorded: pixantrone dimaleate. Conditions recorded: Breast Cancer.\n\nLinked to the drug Pixantrone because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01086605","url":"https://clinicaltrials.gov/study/NCT01086605"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pixantrone"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01086605","phase":"2","setting":"Randomized Phase II Study of Two Doses of Pixantrone in Patients With Metastatic Breast Cancer","sponsor":"Alliance for Clinical Trials in Oncology","started":"2010-05","startedType":"actual","yearReported":2017,"enrolled":46,"enrolledBasis":"registry","outcomes":[{"endpoint":"Proportion of Confirmed Tumor Responses (Complete or Partial Response)","primary":true,"unit":"proportion","arms":[{"name":"Arm I/Group A (Pixantrone IV Day 1)","n":24,"value":0.08,"note":"95% CI 0.01 to 0.27; Figures from the ClinicalTrials.gov results section (first posted 2017-02-23), not from a publication"},{"name":"Arm II/Group B (Pixantrone IV Days 1, 8, and 15)","n":22,"value":0.05,"note":"95% CI 0 to 0.24"}],"source":"https://clinicaltrials.gov/study/NCT01086605?tab=results"},{"endpoint":"Overall Survival Time","unit":"months","arms":[{"name":"Arm I/Group A (Pixantrone IV Day 1)","n":24,"value":16.8,"note":"95% CI 9 to NA; Figures from the ClinicalTrials.gov results section (first posted 2017-02-23), not from a publication"},{"name":"Arm II/Group B (Pixantrone IV Days 1, 8, and 15)","n":22,"value":9.6,"note":"95% CI 4.7 to NA"}],"source":"https://clinicaltrials.gov/study/NCT01086605?tab=results"},{"endpoint":"6-month Progression-free Survival Rate","unit":"proportion","arms":[{"name":"Arm I/Group A (Pixantrone IV Day 1)","n":24,"value":0.375,"note":"95% CI 0.224 to 0.629; Figures from the ClinicalTrials.gov results section (first posted 2017-02-23), not from a publication"},{"name":"Arm II/Group B (Pixantrone IV Days 1, 8, and 15)","n":22,"value":0.265,"note":"95% CI 0.227 to 0.553"}],"source":"https://clinicaltrials.gov/study/NCT01086605?tab=results"}]},{"id":"nct04928222","kind":"trial","name":"Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II)","aka":[],"tldr":"A phase 1/2 trial of Doxorubicin in basal cell carcinoma, run by SkinJect, Inc., active and no longer recruiting.","summary":"Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II) is a phase 1/2 interventional study registered as NCT04928222 by SkinJect, Inc., with 25 participants enrolled, started 2021-09-24 and due to reach its primary completion in 2023-12-30. Interventions recorded: Doxorubicin-containing MNA and Placebo-containing MNA.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04928222","url":"https://clinicaltrials.gov/study/NCT04928222"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["basal-cell-carcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["doxorubicin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04928222","phase":"1/2","setting":"A Trial to Evaluate Placebo Microneedle Arrays in Healthy Human Volunteers (Part I), Followed by Proof of Concept Testing of Efficacy and Safety of Doxorubicin Microneedle Arrays in Subjects With Basal Cell Cancer (Part II)","sponsor":"SkinJect, Inc.","started":"2021-09-24","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02872103","kind":"trial","name":"Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy","aka":[],"tldr":"A phase 3 trial of Efbemalenograstim alfa in Breast cancer, run by EVIVE Biotechnology, completed.","summary":"Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy is a phase 3 interventional study registered as NCT02872103 by EVIVE Biotechnology, with 122 participants recorded, started 2016-08 and reaching its primary completion in 2017-12-20. Interventions recorded: F-627, Placebo. Conditions recorded: Breast Cancer, Neutropenia.\n\nLinked to the drug Efbemalenograstim alfa because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02872103","url":"https://clinicaltrials.gov/study/NCT02872103"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer","male-breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["efbemalenograstim-alfa"],"companies":["evive-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02872103","phase":"3","setting":"A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy","sponsor":"EVIVE Biotechnology","started":"2016-08","yearReported":2019,"enrolled":122,"enrolledBasis":"registry","outcomes":[{"endpoint":"The Duration in Days of Grade 4 (Severe) Neutropenia Observed in Chemotherapy Cycle 1 in Comparison to Placebo","primary":true,"unit":"days","arms":[{"name":"F-627","n":83,"value":1.3,"note":"SD 1.17; Figures from the ClinicalTrials.gov results section (first posted 2019-03-26), not from a publication"},{"name":"Placebo","n":39,"value":3.9,"note":"SD 1.35"}],"source":"https://clinicaltrials.gov/study/NCT02872103?tab=results"}]},{"id":"nct06947928","kind":"trial","name":"Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Car","aka":[],"tldr":"A phase 2/3 trial of Pembrolizumab in merkel cell carcinoma, run by TuHURA Biosciences, Inc., now recruiting.","summary":"Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma is a phase 2/3 interventional study registered as NCT06947928 by TuHURA Biosciences, Inc., with 118 participants planned, started 2025-12-11 and due to reach its primary completion in 2027-03-31. Interventions recorded: IFx-Hu2.0, Placebo, Pembrolizumab. Conditions listed: Advanced Or Metastatic Merkel Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06947928","url":"https://clinicaltrials.gov/study/NCT06947928"}],"tags":["ctgov-ingest"],"related":[],"cancers":["merkel-cell-carcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06947928","phase":"2/3","setting":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of IFx-Hu2.0 as an Adjunctive Therapy to Pembrolizumab in Checkpoint-Inhibitor Naïve Participants With Advanced or Metastatic Merkel Cell Carcinoma","sponsor":"TuHURA Biosciences, Inc.","started":"2025-12-11","startedType":"actual","enrolled":118,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04624204","kind":"trial","name":"Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-","aka":[],"tldr":"A phase 3 trial of Pembrolizumab, Olaparib in small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013) is a phase 3 interventional study registered as NCT04624204 by Merck Sharp & Dohme LLC, with 672 participants planned, started 2020-12-08 and due to reach its primary completion in 2027-10-28. Interventions recorded: Pembrolizumab 200 mg, Pembrolizumab 400 mg, Pembrolizumab placebo (saline), Pembrolizumab placebo (saline), Olaparib 300 mg BID. Conditions listed: Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04624204","url":"https://clinicaltrials.gov/study/NCT04624204"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","limited-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["pembrolizumab","olaparib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04624204","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)","sponsor":"Merck Sharp & Dohme LLC","started":"2020-12-08","startedType":"actual","enrolled":672,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07070622","kind":"trial","name":"Planed Organ Preservation for Low Rectal Cancer After Neoadjuvant Chemotherapy (OPLAR)","aka":["OPLAR"],"tldr":"A phase 3 trial in colorectal cancer, run by West China Hospital, now recruiting.","summary":"Planed Organ Preservation for Low Rectal Cancer After Neoadjuvant Chemotherapy (OPLAR) is a phase 3, randomised interventional study registered as NCT07070622 by West China Hospital, with a registry enrolment figure of 186 participants, started 2024-11-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: patients were assigned to receive TNT or iTNT management. Conditions listed: Rectal Cancer. Primary outcome: organ preservation rate，OPR. Colorectal eligibility wording from the registry: \"rectal adenocarcinoma confirmed by pathology and pMMR/MSS by immunohistochemistry and/or genetic testing;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07070622","url":"https://clinicaltrials.gov/study/NCT07070622"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07070622","phase":"3","setting":"Planed Organ Preservation for Early- and Intermediate-risk Low Rectal Cancer With Good Response to Neoadjuvant Chemotherapy","sponsor":"West China Hospital","started":"2024-11-01","startedType":"actual","enrolled":186,"enrolledBasis":"registry","outcomes":[]},{"id":"plasmamatch","kind":"trial","name":"plasmaMATCH","aka":["plasmaMATCH trial","UK plasmaMATCH"],"tldr":"plasmaMATCH showed that a blood test can find the mutations that steer treatment in advanced breast cancer as reliably as a tumour biopsy, and used it to send women straight to drugs matching rare mutations. It found real activity for neratinib in HER2-mutant and capivasertib in AKT1-mutant disease.","summary":"plasmaMATCH was led by Nicholas Turner at the Institute of Cancer Research and the Royal Marsden and opened in December 2016 at hospitals across the United Kingdom. More than a thousand women with advanced breast cancer had circulating tumour DNA sequenced (with Guardant360 and digital PCR); those with a qualifying mutation entered one of four treatment cohorts: A, ESR1 mutations, extended-dose fulvestrant; B, HER2 mutations, neratinib with or without fulvestrant; C, AKT1 mutations in oestrogen receptor-positive disease, capivasertib with fulvestrant; D, AKT1 mutations in receptor-negative disease or PTEN loss, capivasertib alone. A fifth cohort, E, later gave olaparib with the ATR inhibitor ceralasertib to triple-negative disease.\n\nThe Lancet Oncology report in 2020 established the diagnostic claim: circulating tumour DNA testing agreed with tissue sequencing in the great majority of patients, with sensitivity around 93 percent, so a blood test could stand in for a biopsy to select therapy. On the therapeutic side, neratinib in HER2-mutant cancer and capivasertib with fulvestrant in AKT1-mutant receptor-positive cancer met their pre-set response thresholds (about a quarter and a fifth of patients responding), capivasertib alone in cohort D showed less activity, and extended-dose fulvestrant for ESR1 mutations did not meet its bar. Cohort E, in Clinical Cancer Research in 2023, found limited activity for olaparib with ceralasertib in unselected triple-negative disease. A 2026 analysis showed that the amount of circulating tumour DNA predicted survival across the cohorts.\n\nplasmaMATCH changed United Kingdom practice by validating plasma-first genotyping in advanced breast cancer, contributed the largest neratinib series in HER2-mutant breast cancer alongside SUMMIT, and supplied part of the rationale for capivasertib's development in AKT pathway-altered disease that led to its approval with fulvestrant in 2023. It also modelled a national umbrella run from a blood test, a design DETERMINE and TARGET National inherited.","status":"completed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03182634","url":"https://clinicaltrials.gov/study/NCT03182634"},{"label":"Turner et al., Lancet Oncology 2020: circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH)","url":"https://doi.org/10.1016/S1470-2045(20)30444-7"},{"label":"Olaparib and ceralasertib in triple-negative advanced breast cancer, cohort E of plasmaMATCH, Clinical Cancer Research 2023","url":"https://doi.org/10.1158/1078-0432.CCR-23-1696"},{"label":"Prognostic and predictive impact of ctDNA levels in patients enrolled on the plasmaMATCH trial, Clinical Cancer Research 2026","url":"https://doi.org/10.1158/1078-0432.CCR-24-0651"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","tnbc"],"sections":[],"technologies":["liquid-biopsy","pi3k-akt-mtor-inhibitors","parp-inhibitor","her2-tyrosine-kinase-inhibitors"],"targets":[],"drugs":["fulvestrant","neratinib","capivasertib","olaparib"],"companies":["guardant-health"],"institutions":["icr-london","royal-marsden","cruk"],"pathways":[],"terms":["master-protocol","basket-umbrella-platform","ctdna"],"trials":[],"people":["nicholas-turner"],"bottlenecks":[],"keyPapers":["paper-ring-clin-cancer-res","paper-browne-clin-cancer-res","paper-plasmamatch-lancet-oncol-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03182634","phase":"2","setting":"Advanced breast cancer across the United Kingdom: circulating tumour DNA testing of a blood sample assigns patients with ESR1, HER2 or AKT1 mutations or PTEN loss to matched treatment cohorts, with a later cohort for triple-negative disease","sponsor":"The Institute of Cancer Research, funded by Cancer Research UK","result":"Circulating tumour DNA matched tissue genotyping with about 93 percent sensitivity; neratinib (HER2 mutations) and capivasertib plus fulvestrant (AKT1 mutations, receptor-positive) met their response thresholds; extended-dose fulvestrant for ESR1 mutations did not.","started":"2016-12-15","startedType":"actual","yearReported":2020,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed objective response rate by cohort","primary":true,"unit":"%","arms":[{"name":"Cohort A: ESR1 mutation, extended-dose fulvestrant","n":74,"value":8,"note":"6 of 74; 13 of 78 were required. Cohorts B-D required 3 of 16"},{"name":"Cohort B: HER2 mutation, neratinib (with fulvestrant if ER-positive)","n":20,"value":25},{"name":"Cohort C: AKT1 mutation, ER-positive, capivasertib + fulvestrant","n":18,"value":22},{"name":"Cohort D: AKT1 mutation ER-negative or PTEN mutation, capivasertib","n":19,"value":11}],"source":"https://doi.org/10.1016/S1470-2045(20)30444-7"},{"endpoint":"Sensitivity of digital PCR ctDNA testing for mutations found in tissue sequencing","unit":"%","arms":[{"name":"All patients with tissue comparison","value":93,"note":"95% CI 83-98; 98% (87-100) with contemporaneous biopsies; ctDNA results available for 1034 of 1051 registered"}],"source":"https://doi.org/10.1016/S1470-2045(20)30444-7"}]},{"id":"nct04165590","kind":"trial","name":"Plasmodium Immunotherapy for Advanced Malignant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of an investigational treatment in advanced solid tumours, run by CAS Lamvac Biotech Co., Ltd., now recruiting.","summary":"Plasmodium Immunotherapy for Advanced Malignant Solid Tumors is a phase 1/2 interventional study registered as NCT04165590 by CAS Lamvac Biotech Co., Ltd., with 60 participants planned, started 2019-10-24 and due to reach its primary completion in 2024-04-30.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04165590","url":"https://clinicaltrials.gov/study/NCT04165590"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04165590","phase":"1/2","setting":"Clinical Study of Plasmodium Immunotherapy for Advanced Malignant Solid Tumors","sponsor":"CAS Lamvac Biotech Co., Ltd.","started":"2019-10-24","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04126200","kind":"trial","name":"Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple","aka":["DREAMM 5"],"tldr":"A phase 1/2 trial of Belantamab mafodotin, Nirogacestat, Dostarlimab in multiple myeloma, run by GlaxoSmithKline, active and no longer recruiting.","summary":"Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) is a phase 1/2 interventional study registered as NCT04126200 by GlaxoSmithKline, with 208 participants enrolled, started 2019-10-07 and due to reach its primary completion in 2025-04-17. Interventions recorded: Belantamab mafodotin, GSK3174998, Feladilimab, Nirogacestat, Dostarlimab. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04126200","url":"https://clinicaltrials.gov/study/NCT04126200"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["belantamab-mafodotin","nirogacestat","dostarlimab","isatuximab","lenalidomide","dexamethasone","feladilimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04126200","phase":"1/2","setting":"A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) - DREAMM 5","sponsor":"GlaxoSmithKline","started":"2019-10-07","startedType":"actual","enrolled":208,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05534087","kind":"trial","name":"Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (KCSG CO22-12)","aka":["CLAUDIA"],"tldr":"A phase 3 trial in colorectal cancer, run by Seoul National University Hospital, now recruiting.","summary":"Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (KCSG CO22-12) is a phase 3, randomised interventional study registered as NCT05534087 by Seoul National University Hospital, with a registry enrolment figure of 236 participants, started 2022-12-15 and due to reach its primary completion in 2028-09-30. Interventions recorded: mFOLFIRINOX-FOLFIRI intensified chemotherapy; FOLFOX or CAPOX adjuvant chemotherapy. Conditions listed: Colon Cancer. Primary outcome: 3-year disease-free survival rate. Colorectal eligibility wording from the registry: \"Adenocarcinoma of colon confirmed by histology\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05534087","url":"https://clinicaltrials.gov/study/NCT05534087"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05534087","phase":"3","setting":"A Randomized Controlled Phase III Trial of Treatment Intensification in Stage II-III Colon Cancer Patients With Positive MRD During Adjuvant Chemotherapy","sponsor":"Seoul National University Hospital","started":"2022-12-15","startedType":"actual","enrolled":236,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06300463","kind":"trial","name":"Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases","aka":[],"tldr":"A phase 2 trial of botensilimab and balstilimab in colorectal cancer, run by Weill Medical College of Cornell University, now recruiting.","summary":"Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases is a phase 2, randomised interventional study registered as NCT06300463 by Weill Medical College of Cornell University, with a registry enrolment figure of 24 participants, started 2024-03-26 and due to reach its primary completion in 2026-12. Interventions recorded: Botensilimab; Balstilimab; AGEN1423; Radiation. Conditions listed: Colorectal Cancer Metastatic; Liver Metastases; Colorectal Cancer. Primary outcome: Mean CD8:Treg ratio, as determined by flow cytometry of tumor tissue, at time of surgical resection in each treatment arm. Colorectal eligibility wording from the registry: \"* Diagnosis of metastatic colorectal adenocarcinoma with liver metastases\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06300463","url":"https://clinicaltrials.gov/study/NCT06300463"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["botensilimab","balstilimab"],"companies":["agenus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06300463","phase":"2","setting":"Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases","sponsor":"Weill Medical College of Cornell University","started":"2024-03-26","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05358249","kind":"trial","name":"Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation","aka":["KontRASt-03"],"tldr":"A phase 1/2 trial of JDQ443, Trametinib, Ribociclib in non-small-cell lung cancer and small-cell lung cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation is a phase 1/2 interventional study registered as NCT05358249 by Novartis Pharmaceuticals, with 74 participants enrolled, started 2022-10-24 and due to reach its primary completion in 2026-09-30. Interventions recorded: JDQ443, trametinib, Ribociclib, cetuximab. Conditions listed: KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small Cell Lung, Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05358249","url":"https://clinicaltrials.gov/study/NCT05358249"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","colorectal","kras-g12c-colorectal","kras-g12c-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["jdq443","trametinib","ribociclib","cetuximab"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05358249","phase":"1/2","setting":"KontRASt-03: A Phase Ib/II, Multicenter, Open-label Platform Study of JDQ443 With Select Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation","sponsor":"Novartis Pharmaceuticals","started":"2022-10-24","startedType":"actual","enrolled":74,"enrolledBasis":"registry","outcomes":[]},{"id":"plco-prostate","kind":"trial","name":"PLCO, prostate component (Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial)","aka":["PLCO","PLCO prostate","Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial"],"tldr":"The American screening trial that found no benefit, and the reason is the trial itself: half the men in the group that was supposed to go unscreened were getting PSA tests from their own doctors.","summary":"PLCO randomised 76,693 men at ten United States centres between 1993 and 2001 to annual prostate-specific antigen testing for six years with digital rectal examination for four years, or to usual care. Compliance in the screened group was 85 percent for PSA and 86 percent for rectal examination.\n\nThe finding that matters for reading the result is in the control group: PSA testing there rose from 40 percent in the first year to 52 percent in the sixth, with rectal examination in 41 to 46 percent. The trial therefore compared organised annual screening with widespread opportunistic screening, not with no screening at all.\n\nAfter seven years the incidence of prostate cancer was 116 per 10,000 person-years in the screened group against 95 in the control group, and the death rate was 2.0 against 1.7 per 10,000 person-years, a rate ratio of 1.13 that was not significant. The ten-year data, 67 percent complete at the time of the report, were consistent.","status":"negative","asOf":"2026-09-25","links":[{"label":"PLCO prostate mortality (New England Journal of Medicine 2009)","url":"https://doi.org/10.1056/NEJMoa0810696"},{"label":"ClinicalTrials.gov NCT00002540","url":"https://clinicaltrials.gov/study/NCT00002540"}],"tags":[],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["psa","overdiagnosis"],"trials":["erspc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002540","phase":"3","setting":"Population screening: men randomised at ten United States centres to annual PSA testing for six years with digital rectal examination for four, or to usual care, with death from prostate cancer as the outcome","sponsor":"National Cancer Institute","result":"Prostate cancer death rate 2.0 against 1.7 per 10,000 person-years, rate ratio 1.13 (95 percent confidence interval 0.75 to 1.70), not significant; control-group PSA testing rose from 40 to 52 percent over the six screening years.","started":"1993-11-16","startedType":"actual","yearReported":2009,"enrolledBasis":"registry","outcomes":[{"endpoint":"Death from prostate cancer at 7 years","primary":true,"unit":"per 10,000 person-years","arms":[{"name":"Annual PSA and digital rectal examination","n":38343,"value":2,"note":"50 deaths."},{"name":"Usual care","n":38350,"value":1.7,"note":"44 deaths."}],"hr":1.13,"ci":[0.75,1.7],"source":"https://doi.org/10.1056/NEJMoa0810696"},{"endpoint":"Prostate cancer incidence at 7 years","unit":"per 10,000 person-years","arms":[{"name":"Annual PSA and digital rectal examination","n":38343,"value":116,"note":"2,820 cancers; rate ratio 1.22 (1.16 to 1.29)."},{"name":"Usual care","n":38350,"value":95,"note":"2,322 cancers."}],"source":"https://doi.org/10.1056/NEJMoa0810696"}],"replication":"ERSPC, reported in the same issue of the same journal on the same day, found a 20 percent reduction in prostate cancer mortality. The difference between the two is usually attributed to PLCO's contaminated control arm, its shorter screening interval and its higher PSA threshold for biopsy."},{"id":"nct07133750","kind":"trial","name":"PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of PM8002 in colorectal cancer, run by Biotheus Inc., now recruiting.","summary":"PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer is a phase 2 interventional study registered as NCT07133750 by Biotheus Inc., with 100 participants planned, started 2025-08-19 and due to reach its primary completion in 2027-05. Interventions recorded: PM8002, Chemotherapy Regimen 1, Chemotherapy Regimen 2, Chemotherapy Regimen 3. Conditions listed: CRC (Colorectal Cancer). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07133750","url":"https://clinicaltrials.gov/study/NCT07133750"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07133750","phase":"2","setting":"A Phase II, Multicenter, Open Label, Parallel Cohort Clinical Trial to Evaluate the Efficacy and Safety of PM8002 (BNT327) in Combination With Chemotherapy in First Line MSS or MSI-L/pMMR Metastatic Colorectal Cancer","sponsor":"Biotheus Inc.","started":"2025-08-19","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06616532","kind":"trial","name":"PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial testing PM8002 in small-cell lung cancer and non-small-cell lung cancer, active and no longer recruiting.","summary":"PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06616532, led by Biotheus, and active but no longer recruiting on the registry. Official title: A Multicenter, Open-lable, Randomised Phase III Study of PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer. Planned enrolment is 404 participants (estimated). The study started in 2024-11-13 and primary completion is expected in 2027-01-25. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06616532","url":"https://clinicaltrials.gov/study/NCT06616532"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06616532","phase":"3","setting":"A Multicenter, Open-lable, Randomized Phase III Study of PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer","sponsor":"Biotheus","started":"2024-11-13","startedType":"actual","enrolled":404,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05918445","kind":"trial","name":"PM8002 in the Treatment of Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of PM8002 in advanced solid tumours, run by Biotheus Inc., now recruiting.","summary":"PM8002 in the Treatment of Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05918445 by Biotheus Inc., with 380 participants planned, started 2021-03-09 and due to reach its primary completion in 2025-11-30. Interventions recorded: PM8002.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05918445","url":"https://clinicaltrials.gov/study/NCT05918445"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05918445","phase":"1/2","setting":"Phase Ib/IIa Safety and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients With Advanced Solid Tumors","sponsor":"Biotheus Inc.","started":"2021-03-09","startedType":"actual","enrolled":380,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06419621","kind":"trial","name":"PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC","aka":[],"tldr":"A phase 3 trial testing PM8002 in triple-negative breast cancer, active and no longer recruiting.","summary":"PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC is a phase 3 interventional study registered as NCT06419621, led by Biotheus, and active but no longer recruiting on the registry. Official title: A Multicenter, Randomised, Double-blind Phase III Study of PM8002 or Placebo in Combination With Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer(TNBC). Planned enrolment is 392 participants (estimated). The study started in 2024-06-11 and primary completion is expected in 2027-07. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06419621","url":"https://clinicaltrials.gov/study/NCT06419621"}],"tags":["ctgov-ingest"],"related":[],"cancers":["tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06419621","phase":"3","setting":"A Multicenter, Randomized, Double-blind Phase III Study of PM8002 or Placebo in Combination With Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer(TNBC)","sponsor":"Biotheus","started":"2024-06-11","startedType":"actual","enrolled":392,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06634056","kind":"trial","name":"Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients Undergoing Chemoradiation","aka":["P4-PACIFIC"],"tldr":"A phase 2 trial in lung cancer, run by University Health Network, Toronto, now recruiting.","summary":"Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients Undergoing Chemoradiation is a phase 2, randomised interventional study registered as NCT06634056 by University Health Network, Toronto, with a registry enrolment figure of 150 participants, started 2026-06-15 and due to reach its primary completion in 2031-11-30. Interventions recorded: Pentoxifylline; Placebo; α-Tocopherol. Conditions listed: Non-Small Cell Lung Cancer; Radiation Induced Lung Injury (RILI). Primary outcome: Change in risk of Lung Injury. Lung eligibility wording from the registry: \"* Histologically confirmed diagnosis of stage III NSCLC, planned for treatment with concurrent chemoradiation and consolidation immune checkpoint inhibitor as per standard of care with no medical contraindications to therapy\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06634056","url":"https://clinicaltrials.gov/study/NCT06634056"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06634056","phase":"2","setting":"Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol in Stage III Non-Small Cell Lung Cancer Patients Undergoing Chemoradiation","sponsor":"University Health Network, Toronto","started":"2026-06-15","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"pod1um-201","kind":"trial","name":"POD1UM-201 (retifanlimab in advanced Merkel cell carcinoma)","aka":["POD1UM-201"],"tldr":"The third PD-1 antibody tested in this rare and fast-growing skin cancer shrank it in more than half of the people who took it, and most of those responses lasted years. Six in ten were still alive three years later, in a disease that used to kill within months.","summary":"Merkel cell carcinoma is rare, aggressive and unusually visible to the immune system, either because it carries the Merkel cell polyomavirus or because it is driven by ultraviolet damage with a very high mutational burden. POD1UM-201 tested retifanlimab, a humanised PD-1 antibody, in 101 chemotherapy-naive patients with recurrent locally advanced or metastatic disease across 34 sites in the United States, Canada and Europe.\n\nThe objective response rate was 54.5 per cent (95 per cent confidence interval 44.2 to 64.4), made up of 18 complete responses (17.8 per cent) and 37 partial responses (36.6 per cent), with a disease control rate of 60.4 per cent. Duration matters more than rate in this disease, because chemotherapy responses had been measured in months: median duration of response was not reached in those with a complete response, with a lower confidence bound of 14.0 months, and was 25.3 months in those with a partial response. Median progression-free survival was 16.0 months (9.0 to 32.2) and median overall survival was not reached, with 63 per cent of patients alive at three years.\n\nGrade 3 immune-related adverse events occurred in 11 patients (10.9 per cent), in keeping with the class.\n\nRetifanlimab became the third PD-1 or PD-L1 antibody approved for this disease after avelumab and pembrolizumab, and the three have never been compared with each other. What matters is not which is chosen but that roughly half of the patients respond and most responders keep responding, which is the single largest change in the history of this cancer.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03599713","url":"https://clinicaltrials.gov/study/NCT03599713"},{"label":"Primary report (Journal for ImmunoTherapy of Cancer 2025)","url":"https://doi.org/10.1136/jitc-2025-012478"},{"label":"Primary report on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/40796223/"}],"tags":[],"related":[],"cancers":["merkel-cell-carcinoma","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["retifanlimab"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":["irae","mcpyv-status","tmb"],"trials":["javelin-merkel-200","keynote-017","admec-o"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03599713","phase":"2","setting":"Recurrent locally advanced or metastatic Merkel cell carcinoma not amenable to surgery or radiotherapy, with no previous systemic treatment: retifanlimab 500 mg intravenously every four weeks for up to two years, with objective response rate as the primary endpoint","sponsor":"Incyte Corporation","result":"Objective response in 54.5 per cent (95 per cent confidence interval 44.2 to 64.4) with complete responses in 17.8 per cent, median progression-free survival 16.0 months, and 63 per cent of patients alive at three years.","started":"2019-02-25","startedType":"actual","yearReported":2025,"enrolled":101,"enrolledBasis":"treated","enrolledNote":"101 chemotherapy-naive patients were enrolled between February 2019 and June 2021 across 34 sites and are the population of the efficacy analysis; the ClinicalTrials.gov record NCT03599713 gives an enrolment of 107.","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Retifanlimab 500 mg every 4 weeks","n":101,"value":54.5,"note":"95 per cent confidence interval 44.2 to 64.4; 18 complete and 37 partial responses"}],"source":"https://doi.org/10.1136/jitc-2025-012478"},{"endpoint":"Median progression-free survival","unit":"months","arms":[{"name":"Retifanlimab 500 mg every 4 weeks","n":101,"value":16,"note":"95 per cent confidence interval 9.0 to 32.2"}],"source":"https://doi.org/10.1136/jitc-2025-012478"},{"endpoint":"Overall survival at 3 years","unit":"%","arms":[{"name":"Retifanlimab 500 mg every 4 weeks","n":101,"value":63,"note":"median overall survival not reached"}],"source":"https://doi.org/10.1136/jitc-2025-012478"},{"endpoint":"Grade 3 immune-related adverse events","unit":"%","arms":[{"name":"Retifanlimab 500 mg every 4 weeks","n":101,"value":10.9,"note":"11 of 101 patients"}],"source":"https://doi.org/10.1136/jitc-2025-012478"}],"replication":"JAVELIN Merkel 200 part B found a first-line response rate of 39.7 per cent with avelumab and KEYNOTE-017 found 56 per cent with pembrolizumab, so all three antibodies sit in the same range; none has been compared with another."},{"id":"pod1um-303","kind":"trial","name":"POD1UM-303/InterAACT-2","aka":["POD1UM-303","InterAACT-2","INCMGA 0012-303"],"tldr":"POD1UM-303 showed that adding the immunotherapy retifanlimab to the standard carboplatin-paclitaxel chemotherapy for advanced anal cancer delayed progression by about two months in median terms and reduced the risk of progression by 37 percent, making it the first immunotherapy to improve first-line treatment of this cancer.","summary":"POD1UM-303/InterAACT-2 was a global double-blind phase 3 trial by Incyte that randomised 308 patients with untreated inoperable locally recurrent or metastatic anal squamous cell carcinoma to carboplatin and paclitaxel with retifanlimab 500 mg every four weeks or placebo. The primary endpoint was progression-free survival by blinded independent review.\n\nMedian progression-free survival was 9.3 months with retifanlimab against 7.4 months with placebo (hazard ratio 0.63), and interim overall survival also favoured the antibody; grade 3 or worse adverse events were 83.1 against 75.0 percent, with neutropenia and anaemia most common. Retifanlimab with carboplatin-paclitaxel was approved in the United States in May 2025 for this indication, and the corpus's metastatic anal cancer page lists it as the first-line standard with carboplatin-paclitaxel alone (InterAACT) where the antibody is unavailable.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04472429","url":"https://clinicaltrials.gov/study/NCT04472429"}],"tags":["soc-trials"],"related":[],"cancers":["metastatic-anal-cancer","anal"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["retifanlimab","carboplatin","paclitaxel"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-pod1um-303-retifanlimab-anal-cancer-rao-lancet-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04472429","phase":"3","setting":"Untreated inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal: carboplatin and paclitaxel with the PD-1 antibody retifanlimab or placebo (double-blind), with progression-free survival as the primary endpoint","sponsor":"Incyte Corporation","result":"Median progression-free survival 9.3 months with retifanlimab plus carboplatin-paclitaxel against 7.4 months with placebo (hazard ratio 0.63, one-sided p 0.0006); approved in the United States in May 2025.","started":"2021-01-12","startedType":"actual","yearReported":2025,"enrolled":308,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (blinded independent central review)","primary":true,"unit":"months","arms":[{"name":"Retifanlimab + carboplatin + paclitaxel","n":154,"value":9.3,"note":"95% CI 7.5 to 11.3"},{"name":"Placebo + carboplatin + paclitaxel","n":154,"value":7.4,"note":"95% CI 7.1 to 7.7"}],"hr":0.63,"ci":[0.47,0.84],"p":"0.0006 (one-sided)","source":"https://doi.org/10.1016/S0140-6736(25)00631-2"},{"endpoint":"Grade 3 or worse adverse events","unit":"%","arms":[{"name":"Retifanlimab + carboplatin + paclitaxel","n":154,"value":83.1},{"name":"Placebo + carboplatin + paclitaxel","n":154,"value":75}],"source":"https://doi.org/10.1016/S0140-6736(25)00631-2"},{"endpoint":"Serious adverse events","unit":"%","arms":[{"name":"Retifanlimab + carboplatin + paclitaxel","n":154,"value":47.4},{"name":"Placebo + carboplatin + paclitaxel","n":154,"value":38.8}],"source":"https://doi.org/10.1016/S0140-6736(25)00631-2"}]},{"id":"polar-bear","kind":"trial","name":"POLAR BEAR","aka":["POLAR BEAR trial","R-pola-miniCHP in very old patients"],"tldr":"A Nordic trial asking whether the antibody-drug conjugate that improved first-line treatment for younger patients also helps people in their eighties, who were barely represented in the original trial.","summary":"POLARIX established polatuzumab vedotin in place of vincristine in first-line diffuse large B-cell lymphoma, but it enrolled patients up to 80 and the very old and frail were scarcely represented. The standard for that group is R-miniCHOP, a dose-reduced regimen built for tolerability rather than cure. POLAR BEAR asks the same substitution question in exactly the population POLARIX did not answer for.\n\nEligibility is deliberately narrow and unusual: 80 years or older, or 75 or older and frail by a simplified comprehensive geriatric assessment. Participants are randomised 1 to 1 between R-miniCHOP and R-pola-miniCHP. Both arms run 18 weeks, with follow-up to 36 months after treatment ends. The primary endpoint is progression-free survival, and primary completion is estimated for 28 December 2025, so the first report is close.\n\nSites are open in Sweden, Norway, Finland, Denmark, Italy, Australia and New Zealand. Using a geriatric assessment as an eligibility criterion, rather than age alone, is the methodological contribution: it is the kind of trial design that the gap between trial populations and real lymphoma patients has been waiting for.","status":"active","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT04332822","url":"https://clinicaltrials.gov/study/NCT04332822"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["dlbcl","non-hodgkin-lymphoma"],"sections":["adcs","chemotherapy"],"technologies":["adc"],"targets":["cd79b","cd20"],"drugs":["polatuzumab-vedotin","rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":[],"institutions":[],"pathways":[],"terms":["r-chop","lymphoma-tx-regimen-alphabet"],"trials":["polarix","arched"],"people":[],"bottlenecks":["b-aging-comorbidity","b-trial-diversity","b-trial-enrolment"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04332822","phase":"3","setting":"Aged 80 or over, or 75 or over and frail, with untreated diffuse large B-cell lymphoma: R-miniCHOP against R-pola-miniCHP, which replaces the vincristine with polatuzumab vedotin","sponsor":"Nordic Lymphoma Group","started":"2020-08-19","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"polargo","kind":"trial","name":"POLARGO","aka":["Pola-R-GemOx","POLARGO trial"],"tldr":"Adding an antibody-drug conjugate to a gentle outpatient chemotherapy pairing added about seven months of life for people with relapsed aggressive lymphoma who could not have a transplant.","summary":"Rituximab with gemcitabine and oxaliplatin is the regimen offered when someone with relapsed diffuse large B-cell lymphoma cannot tolerate transplant-intensity salvage, and its results have always been modest. POLARGO added polatuzumab vedotin, the CD79b antibody-drug conjugate already established in the first line by POLARIX.\n\nAfter a 15-patient safety run-in, 255 patients with relapsed or refractory disease (not otherwise specified, or transformed from an indolent lymphoma) who were ineligible for autologous transplant were randomised to polatuzumab with rituximab, gemcitabine and oxaliplatin (129) or to the chemotherapy alone (126), for up to eight 21-day cycles. Overall survival was the primary endpoint, which is unusual and makes the result harder to dismiss. At a median follow-up of 24.6 months the hazard ratio for death was 0.6 (95 per cent confidence interval 0.43 to 0.83, p = 0.0017), with median overall survival 19.5 months against 12.5.\n\nThe cost is real: peripheral neuropathy in 57 per cent against 29 per cent, mostly grade 1, and fatal adverse events in 12 per cent against 4 per cent, largely infections including COVID-19. The trial recruited through the pandemic, which bears on that figure.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT04182204","url":"https://clinicaltrials.gov/study/NCT04182204"},{"label":"Journal of Clinical Oncology 2026","url":"https://doi.org/10.1200/JCO-25-02849"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["dlbcl","non-hodgkin-lymphoma"],"sections":["adcs","chemotherapy"],"technologies":["adc","monoclonal-antibody"],"targets":["cd79b","cd20"],"drugs":["polatuzumab-vedotin","rituximab","gemcitabine","oxaliplatin"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["lymphoma-tx-transplant-role"],"trials":["polarix","starglo","sunmo"],"people":[],"bottlenecks":["b-toxicity-qol","b-aging-comorbidity"],"keyPapers":["paper-polargo-polatuzumab-r-gemox-dlbcl-jco-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04182204","phase":"3","setting":"Relapsed or refractory diffuse large B-cell lymphoma not eligible for an autologous transplant: polatuzumab vedotin added to rituximab, gemcitabine and oxaliplatin","sponsor":"Hoffmann-La Roche","result":"Median overall survival 19.5 against 12.5 months (hazard ratio 0.6, p = 0.0017), with more peripheral neuropathy and more fatal infections.","started":"2020-02-07","startedType":"actual","yearReported":2026,"enrolled":255,"enrolledBasis":"randomised","enrolledNote":"The registry records 270, which includes the 15-patient safety run-in; 255 were randomised and analysed.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Polatuzumab with R-GemOx","n":129,"value":19.5},{"name":"R-GemOx","n":126,"value":12.5}],"hr":0.6,"ci":[0.43,0.83],"p":"0.0017","source":"https://doi.org/10.1200/JCO-25-02849"}],"replication":"Consistent in direction with STARGLO and SUNMO, which added a different class of drug to the same chemotherapy backbone in the same population."},{"id":"polarix","kind":"trial","name":"POLARIX","aka":[],"tldr":"The trial that improved on R-CHOP for the first time in twenty years, by swapping vincristine for an ADC.","summary":"POLARIX, trial NCT03274492 sponsored by Roche and published in the New England Journal of Medicine in 2022, was the trial that improved on R-CHOP in untreated diffuse large B-cell lymphoma for the first time in twenty years, by swapping vincristine for the CD79b antibody-drug conjugate polatuzumab vedotin. It randomised 879 patients aged 18 to 80 with IPI 2 to 5 to Pola-R-CHP or R-CHOP, met its primary progression-free survival endpoint at two years with the benefit holding at five years in the 2025 JCO update, while overall survival was not significantly different and safety was similar; benefit concentrated in ABC-type and higher IPI disease. Whether a progression benefit without a survival benefit justifies the regimen for every patient is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03274492","url":"https://clinicaltrials.gov/study/NCT03274492"},{"label":"NEJM 2022","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2115304"},{"label":"5-year JCO 2025","url":"https://ascopubs.org/doi/10.1200/JCO-25-00925"}],"tags":[],"related":["lymphoma-roadmap","polargo","polar-bear","flyer","goya"],"cancers":["dlbcl"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["polatuzumab-vedotin","doxorubicin"],"companies":["lysa"],"institutions":[],"pathways":[],"terms":["pfs","ipi-score"],"trials":[],"people":["gilles-salles","herve-tilly","laurie-sehn"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03274492","phase":"3","setting":"Untreated DLBCL, IPI 2-5, age 18-80: Pola-R-CHP vs R-CHOP","sponsor":"Roche","result":"2-year PFS 76.7% vs 70.2%, HR 0.73; 5-year OS HR 0.85 (NS).","started":"2017-11-16","startedType":"actual","yearReported":2021,"enrolled":879,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 1,000 participants (actual); the NEJM 2022 primary analysis randomised 879 patients (440 Pola-R-CHP, 439 R-CHOP).","outcomes":[{"endpoint":"Progression-free survival at 2 years","primary":true,"unit":"%","arms":[{"name":"Pola-R-CHP","n":440,"value":76.7},{"name":"R-CHOP","n":439,"value":70.2}],"hr":0.73,"ci":[0.57,0.95],"p":"0.02","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2115304"},{"endpoint":"Progression-free survival at 5 years","unit":"%","arms":[{"name":"Pola-R-CHP","value":64.9},{"name":"R-CHOP","value":59.1}],"hr":0.77,"ci":[0.62,0.97],"source":"https://ascopubs.org/doi/10.1200/JCO-25-00925"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Pola-R-CHP","value":82.3},{"name":"R-CHOP","value":79.5}],"hr":0.85,"ci":[0.63,1.15],"source":"https://ascopubs.org/doi/10.1200/JCO-25-00925"}],"replication":"Consistent with the phase 1b/2 GO29044 cohort; POLAR BEAR (elderly) and real-world series broadly concordant; no OS benefit at 5 years."},{"id":"polcagb","kind":"trial","name":"POLCAGB","aka":[],"tldr":"In Mumbai, where gallbladder cancer is common, POLCAGB randomised patients with locally advanced but non-metastatic gallbladder cancer to chemotherapy or chemoradiotherapy before surgery. It is the largest randomised trial in gallbladder cancer alone and finished recruiting 124 patients in 2025.","summary":"POLCAGB (NCT02867865) is a randomised trial at Tata Memorial Hospital comparing neoadjuvant chemotherapy with neoadjuvant chemoradiotherapy in biopsy-proven locally advanced gallbladder cancer (T3-4 with predefined clinical and radiological features), excluding resectable and metastatic disease. The protocol planned 314 patients to detect an improvement in median overall survival from 11 to 16.5 months (hazard ratio 0.7) with 80 percent power; the primary endpoint is overall survival, with progression-free survival, R0 resection rate, toxicity, postoperative complications and quality of life as secondary endpoints. The rationale came from a pilot in which neoadjuvant chemoradiation (55 to 57 Gy in 25 fractions with weekly gemcitabine) gave partial or complete response in 77 percent of 26 patients and R0 resection in 46 percent, with biliary leaks in 46 percent linked to the dose to the central hepatobiliary system. The registry lists the trial as phase 2/3, active but no longer recruiting, with 124 patients enrolled and primary completion on 10 September 2025; results were not found in Europe PMC in September 2026. It is the reference trial for chemoradiotherapy as a neoadjuvant strategy in gallbladder cancer.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02867865","url":"https://clinicaltrials.gov/study/NCT02867865"},{"label":"Engineer et al., BMJ Open 2019: POLCAGB protocol","url":"https://doi.org/10.1136/bmjopen-2018-028147"},{"label":"Predictors of toxicity after neoadjuvant chemoradiotherapy for locally advanced gall bladder cancer (Indian J Cancer 2022)","url":"https://doi.org/10.4103/ijc.ijc_822_19"}],"tags":["india"],"related":[],"cancers":["gallbladder","incidental-gallbladder-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","gallbladder-cancer-surgery"],"targets":[],"drugs":["gemcitabine-cisplatin","gemcitabine","cisplatin"],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":["chemoradiation","staging-laparoscopy","neoadjuvant-adjuvant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-polcagb-protocol-bmj-open-2019"],"journals":[],"dependsOn":[],"notes":["Key facts: biopsy-proven locally advanced (T3 to 4) non-metastatic gallbladder cancer; neoadjuvant gemcitabine-based chemotherapy versus chemoradiotherapy before attempted resection with staging laparoscopy and PET-CT; primary endpoint overall survival, powered for 11 versus 16.5 months (hazard ratio 0.7) with 314 planned; 124 enrolled, active but not recruiting, primary completion 10 September 2025. The pilot that motivated it gave response in 77 percent of 26 patients and R0 resection in 46 percent, with biliary leaks in 46 percent tied to the dose to the central hepatobiliary system.","Enrolment: 124 actual against 314 planned in the protocol paper.","Registered with the Clinical Trials Registry India as CTRI/2016/08/007199; study completion is listed for 10 September 2027."],"nct":"NCT02867865","phase":"2/3","setting":"Locally advanced (T3-4) gallbladder cancer: neoadjuvant gemcitabine-based chemotherapy versus neoadjuvant chemoradiotherapy before attempted resection, with staging laparoscopy and PET-CT","sponsor":"Tata Memorial Hospital","started":"2016-09-06","startedType":"actual","enrolled":124,"enrolledBasis":"registry","outcomes":[]},{"id":"polo","kind":"trial","name":"POLO","aka":[],"tldr":"The first biomarker-directed drug approval in pancreatic cancer, for the roughly 5-7% with inherited BRCA mutations, though it did not extend overall survival.","summary":"POLO, trial NCT02184195 sponsored by AstraZeneca and Merck and reported in 2019, produced the first biomarker-directed drug approval in pancreatic cancer, for the roughly five to seven percent of patients with inherited BRCA mutations, though it did not extend overall survival. It randomised 154 patients with germline BRCA-mutated metastatic disease that had not progressed on at least sixteen weeks of platinum chemotherapy to olaparib maintenance or placebo, met its primary progression-free survival endpoint and led to FDA approval in December 2019, but overall survival was no different. OnCo links it to PARP inhibitors and germline testing, to BRCA1 and BRCA2 and PARP as targets. It is a single pivotal trial with no confirmatory study, and whether a progression benefit alone justifies maintenance is the open question.","status":"mixed","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT02184195","url":"https://clinicaltrials.gov/study/NCT02184195"},{"label":"Lynparza label (openFDA): POLO study section","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22LYNPARZA%22"},{"label":"Kindler et al., POLO overall survival (JCO 2022)","url":"https://doi.org/10.1200/JCO.21.01604"}],"tags":[],"related":[],"cancers":["pancreatic","brca-palb2-pdac"],"sections":[],"technologies":["parp-inhibitor","germline-testing"],"targets":["brca","parp"],"drugs":["olaparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":["panoptimox-prodige-35","nct05093231"],"people":["talia-golan","hedy-kindler"],"bottlenecks":[],"keyPapers":["paper-golan-brca-pancreatic-platinum-survival-bjc-2014","paper-park-hrd-pancreatic-platinum-ccr-2020"],"journals":[],"dependsOn":[],"notes":["Design (NEJM 2019): 3,315 patients screened for a germline BRCA mutation to randomise 154 (92 olaparib 300 mg twice daily, 62 placebo) at sites in 12 countries including nine in the UK (Edinburgh, Glasgow, Liverpool, London, Manchester, Northwood, Nottingham, Surrey); 75 percent had received FOLFIRINOX, 30 percent carried BRCA1 and 69 percent BRCA2 (label). Final overall survival (JCO 2022): 19.0 against 19.2 months (hazard ratio 0.83, 0.56 to 1.22; p 0.3487), curves separating at about 24 months with three-year survival 33.9 against 17.8 percent; time to first subsequent therapy or death hazard ratio 0.44 and to second subsequent therapy 0.61 favoured olaparib; grade 3 or worse adverse events 40 against 23 percent in the primary report. Regulators: FDA approval December 2019 (Lynparza label indication 1.6); EU indication listed; NICE appraisal TA750 terminated on 8 December 2021 without a company submission."],"nct":"NCT02184195","phase":"3","setting":"Germline BRCA-mutated metastatic PDAC not progressed on ≥16 weeks of platinum: olaparib maintenance vs placebo","sponsor":"AstraZeneca / Merck","result":"PFS HR 0.53; OS HR 0.83 (not significant).","started":"2014-12-16","startedType":"actual","yearReported":2019,"enrolled":154,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Olaparib maintenance","n":92,"value":7.4},{"name":"Placebo","n":62,"value":3.8}],"hr":0.53,"ci":[0.35,0.82],"p":"0.004","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1903387"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Olaparib maintenance","value":19,"note":"Not significant"},{"name":"Placebo","value":19.2}],"hr":0.83,"source":"https://ascopubs.org/doi/10.1200/JCO.21.01604"}],"replication":"Single pivotal trial; PFS but not OS. No confirmatory trial."},{"id":"nct06752811","kind":"trial","name":"Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial of Gemcitabine in pancreatic ductal adenocarcinoma, run by Shanghai Yizhong Pharmaceutical Co., Ltd., now recruiting.","summary":"Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer is a phase 3 interventional study registered as NCT06752811 by Shanghai Yizhong Pharmaceutical Co., Ltd., with 416 participants planned, started 2025-02-05 and due to reach its primary completion in 2027-07-01. Interventions recorded: paclitaxel polymeric micelles for injection, Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (albumin bound ).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06752811","url":"https://clinicaltrials.gov/study/NCT06752811"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06752811","phase":"3","setting":"A Multi-center, Randomized, Open, Parallel-group, Positive Drug-controlled Phase III Clinical Trial for Evaluating the Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection Plus Gemcitabine and Paclitaxel for Injection (Albumin-bound) Plus Gemcitabine for Injection in the First-line Treatment of Metastatic Pancreatic Cancer","sponsor":"Shanghai Yizhong Pharmaceutical Co., Ltd.","started":"2025-02-05","startedType":"actual","enrolled":416,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07159204","kind":"trial","name":"Polymeric Micellar Paclitaxel-Based Combination Therapy for Advanced Biliary Tract Cancer","aka":["PILOT-BTC"],"tldr":"A phase 2 trial of paclitaxel in gallbladder cancer and other biliary tract cancers, run by Peking Union Medical College Hospital, active and no longer recruiting.","summary":"Polymeric Micellar Paclitaxel-Based Combination Therapy for Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT07159204 by Peking Union Medical College Hospital, with a registry enrolment figure of 61 participants, started 2024-08-07 and due to reach its primary completion in 2026-08-12. Interventions recorded: Paclitaxel polymer micelle immunocombination. Conditions listed: Biliary Tract Cancer (BTC). Gallbladder cancer is named in the registry entry: \"* Patients with advanced biliary tract carcinoma diagnosed by imaging and histology as unresectable, recurrent, locally advanced, or metastatic disease, defined as stage IIIA or above according to the AJCC 8th edition st\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07159204","url":"https://clinicaltrials.gov/study/NCT07159204"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07159204","phase":"2","setting":"Polymeric Micellar Paclitaxel-Based Chemoimmunotherapy Plus Lenvatinib After First-Line Chemoimmunotherapy in Advanced Biliary Tract Cancer","sponsor":"Peking Union Medical College Hospital","started":"2024-08-07","startedType":"actual","enrolled":61,"enrolledBasis":"registry","outcomes":[]},{"id":"ponsegromab-phase-2","kind":"trial","name":"Ponsegromab phase 2 in cancer cachexia","aka":[],"tldr":"The first drug to hit the hormone behind cancer wasting: patients on the highest dose gained nearly 3 kg more than placebo in 12 weeks and reported better appetite and more activity.","summary":"187 patients with cachexia (weight loss at least 5%, or 2% with BMI under 20) and GDF-15 at least 1,500 pg/mL were randomised. The primary endpoint, change in body weight at 12 weeks, showed placebo-adjusted gains of 1.22 kg (100 mg), 1.92 kg (200 mg) and 2.81 kg (400 mg). At 400 mg there were also improvements in appetite and cachexia symptoms, physical activity measured by accelerometer, and lumbar skeletal muscle index, and no increase in adverse events versus placebo. Follow-on work: a phase 2/3 programme in pancreatic cancer cachexia (NCT06989437, recruiting) and planned lung cancer studies, with functional and survival endpoints. The trial is the proof of concept that cachexia is a drug-treatable disease; it did not test survival, and 12 weeks is short.","status":"positive","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT05546476","url":"https://clinicaltrials.gov/study/NCT05546476"},{"label":"Groarke et al. (NEJM 2024)","url":"https://doi.org/10.1056/NEJMoa2409515"}],"tags":[],"related":["idea-cachexia-gdf15-prevention","idea-bio2-gdf15-plus-exercise","idea-bio2-gdf15-stratified-enrolment"],"cancers":["nsclc","pancreatic","colorectal"],"sections":["nutrition-lifestyle","supportive-care"],"technologies":["cachexia-therapy","cachexia-appetite-pharmacotherapy"],"targets":[],"drugs":[],"companies":["pfizer"],"institutions":[],"pathways":["cachexia-biology"],"terms":["cachexia","body-composition"],"trials":["nct06989437"],"people":[],"bottlenecks":["b-cachexia-supportive"],"keyPapers":["paper-groarke-ponsegromab-cancer-cachexia-nejm-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05546476","phase":"2","setting":"NSCLC, pancreatic or colorectal cancer with cachexia and elevated serum GDF-15: ponsegromab 100, 200 or 400 mg subcutaneously every 4 weeks vs placebo for 12 weeks","sponsor":"Pfizer","result":"Placebo-adjusted weight gain 2.81 kg at 400 mg over 12 weeks; improved appetite and activity.","started":"2022-11-21","startedType":"actual","yearReported":2024,"enrolled":187,"enrolledBasis":"registry","outcomes":[{"endpoint":"Change in body weight at 12 weeks (placebo-adjusted)","primary":true,"unit":"kg","arms":[{"name":"Ponsegromab 400 mg","value":2.81},{"name":"Ponsegromab 200 mg","value":1.92},{"name":"Ponsegromab 100 mg","value":1.22},{"name":"Placebo","value":0}],"source":"https://doi.org/10.1056/NEJMoa2409515"}],"replication":"Phase 2/3 in pancreatic cancer cachexia underway (NCT06989437)."},{"id":"pop-rt","kind":"trial","name":"POP-RT","aka":[],"tldr":"POP-RT, from Mumbai, showed that treating the pelvic lymph nodes as well as the prostate improves disease control in high-risk prostate cancer, reviving a question earlier trials had left unanswered.","summary":"POP-RT randomised 224 men with high-risk, node-negative prostate cancer (most staged with PSMA PET) to image-guided prostate-only or whole-pelvic radiotherapy with two years of androgen deprivation. Five-year biochemical failure-free survival was 95 percent with pelvic radiotherapy and 81.2 percent with prostate-only treatment (hazard ratio 0.23), with better disease-free survival and more late urinary toxicity (Murthy and colleagues, Journal of Clinical Oncology 2021).","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01952223","url":"https://clinicaltrials.gov/study/NCT01952223"},{"label":"JCO 2021","url":"https://doi.org/10.1200/JCO.20.03282"}],"tags":["radiation-wave4"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["imrt-igrt","psma-pet"],"targets":[],"drugs":[],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-murthy-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01952223","phase":"3","setting":"High-risk node-negative prostate cancer: prostate-only versus whole-pelvic radiotherapy, both with hormone therapy","sponsor":"Tata Memorial Centre, Mumbai","result":"5-year biochemical failure-free survival 95% (whole pelvis) vs 81.2% (prostate only).","started":"2013-12","startedType":"actual","yearReported":2021,"enrolled":224,"enrolledBasis":"registry","outcomes":[{"endpoint":"Biochemical failure-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Whole-pelvic radiotherapy","n":110,"value":95},{"name":"Prostate-only radiotherapy","n":114,"value":81.2}]}]},{"id":"portec-2","kind":"trial","name":"PORTEC-2","aka":[],"tldr":"PORTEC-2 showed that a short course of internal radiotherapy to the top of the vagina prevented local recurrence of endometrial cancer as well as several weeks of external pelvic radiotherapy, with far fewer bowel side effects, and it became the standard for intermediate-risk disease.","summary":"PORTEC-1 had shown that external beam radiotherapy reduces locoregional recurrence without improving survival in stage I endometrial cancer, and that most recurrences were in the vagina. PORTEC-2 randomised 427 women with high-intermediate-risk stage I disease (defined by age, grade and depth of invasion) to vaginal brachytherapy or external beam pelvic radiotherapy. The primary endpoint was vaginal recurrence.\n\nVaginal recurrence rates were low and similar in both arms, with no difference in overall survival, and vaginal brachytherapy caused far less gastrointestinal toxicity and better quality of life. It became the standard adjuvant treatment for this risk group worldwide. The later molecular analysis of the PORTEC trials showed that POLE-mutated tumours almost never recur whatever the treatment, and that p53-abnormal tumours do poorly, the basis of the molecular classification now used to tailor adjuvant therapy.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00376844","url":"https://clinicaltrials.gov/study/NCT00376844"}],"tags":["subtype-trials"],"related":[],"cancers":["endometrial-nsmp","endometrial-pole-ultramutated","endometrial"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["remi-nout"],"bottlenecks":[],"keyPapers":["paper-portec-2-lancet-2010"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00376844","phase":"3","setting":"High-intermediate-risk stage I endometrial cancer after surgery: vaginal brachytherapy against external beam pelvic radiotherapy","sponsor":"Leiden University Medical Center (Dutch PORTEC group)","result":"Vaginal brachytherapy gave similar vaginal control and survival to external beam radiotherapy with less gastrointestinal toxicity.","started":"2002-05","yearReported":2010,"enrolled":427,"enrolledBasis":"registry","outcomes":[{"endpoint":"Vaginal recurrence at 5 years","primary":true,"unit":"%","arms":[{"name":"Vaginal brachytherapy","n":213,"value":1.8,"note":"Median follow-up 45 months; non-inferiority margin 6 percentage points"},{"name":"Pelvic external beam radiotherapy","n":214,"value":1.6}],"hr":0.78,"ci":[0.17,3.49],"p":"0.74","source":"https://doi.org/10.1016/S0140-6736(09)62163-2"},{"endpoint":"Locoregional relapse at 5 years","unit":"%","arms":[{"name":"Vaginal brachytherapy","n":213,"value":5.1},{"name":"Pelvic external beam radiotherapy","n":214,"value":2.1}],"hr":2.08,"ci":[0.71,6.09],"p":"0.17","source":"https://doi.org/10.1016/S0140-6736(09)62163-2"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Vaginal brachytherapy","n":213,"value":84.8},{"name":"Pelvic external beam radiotherapy","n":214,"value":79.6}],"hr":1.17,"ci":[0.69,1.98],"p":"0.57","source":"https://doi.org/10.1016/S0140-6736(09)62163-2"},{"endpoint":"Acute grade 1-2 gastrointestinal toxicity at completion of radiotherapy","unit":"%","arms":[{"name":"Vaginal brachytherapy","n":215,"value":12.6},{"name":"Pelvic external beam radiotherapy","n":208,"value":53.8}],"source":"https://doi.org/10.1016/S0140-6736(09)62163-2"}]},{"id":"portec-3","kind":"trial","name":"PORTEC-3","aka":[],"tldr":"Adding chemotherapy to radiation after surgery helped women with high-risk endometrial cancer, especially those whose tumours have a broken p53 gene.","summary":"5-year OS 81.4% vs 76.1% (HR 0.70) and failure-free survival 76.5% vs 69.1% in the updated analysis (Lancet Oncology 2019); the benefit was largest in stage III and serous cancers. Molecular analysis (de Boer/León-Castillo, JCO 2020) showed strong benefit in p53-abnormal tumours and none in POLE-mutated tumours, the basis for molecular-class-directed adjuvant therapy now tested in RAINBO.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00411138","url":"https://clinicaltrials.gov/study/NCT00411138"},{"label":"Lancet Oncology 2019","url":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30395-X/fulltext"}],"tags":[],"related":[],"cancers":["endometrial","endometrial-p53-abnormal","endometrial-pole-ultramutated","endometrial-nsmp"],"sections":[],"technologies":["imrt-igrt","cytotoxic-chemotherapy","brachytherapy"],"targets":["tp53"],"drugs":[],"companies":["trog"],"institutions":[],"pathways":[],"terms":["endometrial-molecular-classes"],"trials":[],"people":["carien-creutzberg"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00411138","phase":"3","setting":"High-risk early or stage III endometrial cancer after surgery: chemoradiation + 4 cycles chemotherapy vs pelvic radiotherapy alone","sponsor":"Dutch Gynaecological Oncology Group","result":"5-year OS 81.4% vs 76.1% (HR 0.70); benefit concentrated in p53-abnormal disease.","started":"2006-11-23","startedType":"actual","yearReported":2018,"enrolled":660,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Chemoradiation + chemotherapy","n":330,"value":81.4},{"name":"Radiotherapy alone","n":330,"value":76.1}],"hr":0.7,"ci":[0.51,0.97],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30395-X/fulltext"}],"replication":"GOG-258 (chemoradiation vs chemotherapy alone) found no RFS difference, so the incremental value of radiation remains debated."},{"id":"nct06802757","kind":"trial","name":"Posaconazole Plus PD-1 Inhibitors and Chemotherapy vs PD-1 Inhibitors and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer","aka":["PRISM-TNBC"],"tldr":"A phase 2 trial of nab-paclitaxel, carboplatin and cyclophosphamide in triple-negative breast cancer, run by Shandong Cancer Hospital and Institute, now recruiting.","summary":"Posaconazole Plus PD-1 Inhibitors and Chemotherapy vs PD-1 Inhibitors and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer is a phase 2, randomised interventional study registered as NCT06802757 by Shandong Cancer Hospital and Institute, with a registry enrolment figure of 72 participants, started 2025-05-01 and due to reach its primary completion in 2026-06-30. Interventions recorded: Posaconazole; Nab-paclitaxel; Carboplatin; Anthracycline; Cyclophosphamide; PD-1 inhibitors. Conditions listed: Breast Cancer. Triple-negative eligibility wording from the registry: \"first-confirmed TNBC;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06802757","url":"https://clinicaltrials.gov/study/NCT06802757"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["nab-paclitaxel","carboplatin","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06802757","phase":"2","setting":"A Phase II, Randomised, Open-label, Multicentre Study of Posaconazole Plus PD-1 Inhibitors and Chemotherapy Versus PD-1 Inhibitors and Chemotherapy as Neoadjuvant Therapy for Triple Negative Breast Cancer","sponsor":"Shandong Cancer Hospital and Institute","started":"2025-05-01","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06056830","kind":"trial","name":"Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy","aka":["CLARIFY"],"tldr":"A phase 3 trial of 64Cu-SAR-bisPSMA in prostate cancer, run by Clarity Pharmaceuticals Ltd, now recruiting.","summary":"Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy is a phase 3 interventional study registered as NCT06056830 by Clarity Pharmaceuticals Ltd, with 383 participants planned, started 2023-12-21 and due to reach its primary completion in 2026-09. Interventions recorded: 64Cu-SAR-bisPSMA.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06056830","url":"https://clinicaltrials.gov/study/NCT06056830"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["clarity-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06056830","phase":"3","setting":"Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study","sponsor":"Clarity Pharmaceuticals Ltd","started":"2023-12-21","startedType":"actual","enrolled":383,"enrolledBasis":"registry","outcomes":[]},{"id":"posnoc","kind":"trial","name":"POSNOC","aka":["POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy"],"tldr":"The British trial that asks the question SENOMAC left open: not whether the armpit operation can be skipped, but whether the armpit can be left untreated altogether. Results are not published yet.","summary":"POSNOC is a pragmatic multicentre non-inferiority trial that randomised 1,900 women with one or two sentinel node macrometastases 1:1 to adjuvant therapy alone or to adjuvant therapy plus axillary treatment, the latter being either axillary node clearance or axillary radiotherapy at the centre's choice. Randomisation was stratified by institution, age, breast-conserving surgery or mastectomy, oestrogen receptor status, number of positive nodes and whether intraoperative one-step nucleic acid amplification was used.\n\nThe design detail that makes POSNOC different from Z0011 and SENOMAC is a prohibition: in the adjuvant-therapy-alone arm, axillary and supraclavicular fossa radiotherapy is not allowed. Breast or chest-wall radiotherapy is. So the experimental arm genuinely receives no axillary treatment, which is not true of either predecessor, and the trial includes women having mastectomy and women with microscopic extranodal invasion, neither of whom Z0011 admitted. The United Kingdom Radiotherapy Trials Quality Assurance Group runs an in-built radiotherapy quality assurance programme, so the fields are documented rather than assumed.\n\nThe primary endpoint is axillary recurrence within five years, with arm morbidity measured by the Lymphoedema and Breast Cancer Questionnaire and QuickDASH, quality of life by FACT B+4, and a health-economic evaluation. Recruitment opened on 1 August 2014 and closed at the 1,900 target; the ClinicalTrials.gov record gives an estimated primary completion of July 2026 and the trial is listed as active and no longer recruiting. No results have been published, and none are quoted here.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02401685","url":"https://clinicaltrials.gov/study/NCT02401685"},{"label":"ISRCTN54765244","url":"https://www.isrctn.com/ISRCTN54765244"},{"label":"POSNOC protocol (BMJ Open 2021)","url":"https://doi.org/10.1136/bmjopen-2021-054365"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["sentinel-node"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["sentinel-lymph-node-biopsy","axillary-surgery-de-escalation","breast-cancer-related-lymphoedema"],"trials":["acosog-z0011","senomac","amaros","atnec"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02401685","phase":"3","setting":"T1 or T2 unifocal or multifocal invasive breast cancer with one or two sentinel node macrometastases, with or without extranodal extension: adjuvant systemic therapy alone against adjuvant therapy plus axillary clearance or axillary radiotherapy, with axillary recurrence within five years as the primary endpoint","sponsor":"University Hospitals of Derby and Burton NHS Foundation Trust","started":"2014-08-01","startedType":"actual","enrolled":1900,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05008809","kind":"trial","name":"Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)","aka":["FIRE-9"],"tldr":"A phase 3 trial of fOLFOX (5-FU, leucovorin, oxaliplatin), FOLFOXIRI, fOLFIRI (5-FU, leucovorin, irinotecan) and cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Dominik Paul Modest, now recruiting.","summary":"Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418) is a phase 3, randomised interventional study registered as NCT05008809 by Dominik Paul Modest, with a registry enrolment figure of 507 participants, started 2021-12-06 and due to reach its primary completion in 2027-11. Interventions recorded: mFOLFOX6; mFOLFOXIRI; FOLFIRI; CAPOX. Conditions listed: Colorectal Cancer. Primary outcome: Progression-free survival (PFS) time. Colorectal eligibility wording from the registry: \"Histologically confirmed adenocarcinoma of the colon or rectum\". Sites: Germany. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05008809","url":"https://clinicaltrials.gov/study/NCT05008809"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","thermal-ablation","topoisomerase-inhibitors"],"targets":[],"drugs":["folfox","folfoxiri","folfiri","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05008809","phase":"3","setting":"Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer Prospective, Randomized, Open, Multicenter Phase III Trial to Investigate the Efficacy of Active Post-resection/Ablation Therapy in Patients With Metastatic Colorectal Cancer","sponsor":"Dominik Paul Modest","started":"2021-12-06","startedType":"actual","enrolled":507,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04365374","kind":"trial","name":"Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)","aka":[],"tldr":"A phase 3 trial of Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) in brain and spinal cord tumours, run by GT Medical Technologies, Inc., active and no longer recruiting.","summary":"Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study) is a phase 3 interventional study registered as NCT04365374 by GT Medical Technologies, Inc., with 230 participants enrolled, started 2021-04-06 and due to reach its primary completion in 2029-08-30. Interventions recorded: Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) and Stereotactic Radiation Therapy.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04365374","url":"https://clinicaltrials.gov/study/NCT04365374"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["brain-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["gt-medical-technologies"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04365374","phase":"3","setting":"A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) Versus Surgically Targeted Radiation Therapy (STaRT) With Gamma Tile for Treatment of Newly Diagnosed Metastatic Brain Tumors.","sponsor":"GT Medical Technologies, Inc.","started":"2021-04-06","startedType":"actual","enrolled":230,"enrolledBasis":"registry","outcomes":[]},{"id":"postmonarch","kind":"trial","name":"postMONARCH","aka":[],"tldr":"Continuing CDK4/6 blockade with a different drug after the first one fails gives a small but real benefit.","summary":"postMONARCH, trial NCT05169567 sponsored by Eli Lilly and reported in 2024, showed that continuing CDK4/6 blockade with a different drug after the first one fails gives a small but real benefit in HR-positive, HER2-negative advanced breast cancer. It randomised 368 women who had progressed on a CDK4/6 inhibitor plus endocrine therapy to abemaciclib or placebo with fulvestrant and met its primary progression-free survival endpoint, the first placebo-controlled phase 3 to show benefit from CDK4/6 inhibition beyond progression, with the largest gains in tumours without ESR1 or PIK3CA mutations. OnCo links it to CDK4/6 as a target, abemaciclib and fulvestrant. The absolute gain is modest, and whether biomarkers can pick the patients who benefit is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05169567","url":"https://clinicaltrials.gov/study/NCT05169567"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":["cdk4-6"],"drugs":["abemaciclib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05169567","phase":"3","setting":"HR+/HER2- advanced breast cancer after progression on CDK4/6 + endocrine therapy: abemaciclib + fulvestrant vs placebo + fulvestrant","sponsor":"Eli Lilly","result":"PFS 6.0 vs 5.3 months, HR 0.73.","started":"2022-03-11","startedType":"actual","yearReported":2024,"enrolled":368,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Abemaciclib + fulvestrant","n":182,"value":6},{"name":"Placebo + fulvestrant","n":186,"value":5.3}],"hr":0.73,"ci":[0.57,0.95],"p":"0.017","source":"https://ascopubs.org/doi/10.1200/JCO-24-02086"}],"replication":"Contrasts with the negative PACE and PALMIRA trials of continuing palbociclib; MAINTAIN (ribociclib switch) was positive in phase 2."},{"id":"nct05797077","kind":"trial","name":"Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA","aka":[],"tldr":"A phase 3 trial of capecitabine in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA is a phase 3, randomised interventional study registered as NCT05797077 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 346 participants, started 2023-02-20 and due to reach its primary completion in 2029-02-20. Interventions recorded: Colorectal resection surgery.; FOLFOX chemotherapy regimen; Capecitabine. Conditions listed: Colorectal Cancer; Liver Metastases; Circulating Tumor Cell; Cancer, Therapy-Related. Primary outcome: 3-years Progression Free Survival; 5-years Progression Free Survival. Colorectal eligibility wording from the registry: \"Patients with liver metastatic colorectal cancer who have undergone R0 resection based on MDT evaluation (including patients whose metastases have been treated with ablation achieving similar R0 resection effect);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05797077","url":"https://clinicaltrials.gov/study/NCT05797077"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","mrd-testing"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05797077","phase":"3","setting":"Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2023-02-20","startedType":"actual","enrolled":346,"enrolledBasis":"registry","outcomes":[]},{"id":"potomac","kind":"trial","name":"POTOMAC","aka":[],"tldr":"Adding a year of durvalumab to standard BCG bladder instillations cut the risk of recurrence or progression by about a third, the first systemic immunotherapy approved in early bladder cancer.","summary":"POTOMAC, trial NCT03528694 sponsored by AstraZeneca and reported in 2025, showed that adding a year of durvalumab to standard BCG bladder instillations in BCG-naive high-risk non-muscle-invasive bladder cancer cut the risk of recurrence or progression by about a third, making it the first systemic immunotherapy approved in early bladder cancer. It randomised 1,018 patients to durvalumab plus BCG induction and maintenance or BCG alone, met its primary disease-free survival endpoint and led to FDA approval on 28 May 2026. OnCo links it to bladder cancer, durvalumab, intravesical BCG, the NMIBC term and the pairing of durvalumab with BCG. The result raises questions of overtreatment, since BCG alone succeeds long term in many patients, and adds systemic toxicity to a bladder-only disease, which is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03528694","url":"https://clinicaltrials.gov/study/NCT03528694"}],"tags":[],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","bcg-intravesical"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["nmibc-vs-mibc"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03528694","phase":"3","setting":"BCG-naive high-risk non-muscle-invasive bladder cancer: durvalumab + BCG (induction and maintenance) vs BCG","sponsor":"AstraZeneca","result":"DFS HR 0.68.","started":"2018-05-14","startedType":"actual","yearReported":2025,"enrolled":1018,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival","primary":true,"arms":[{"name":"Durvalumab + BCG (induction + maintenance)"},{"name":"BCG (induction + maintenance)"}],"hr":0.68,"ci":[0.5,0.93],"p":"0.0154","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder"}],"replication":"KEYNOTE-676 (pembrolizumab + BCG) and CREST (sasanlimab + BCG, positive 2025) test the same concept; ALBAN (atezolizumab + BCG) was negative."},{"id":"pre-bra","kind":"trial","name":"Pre-BRA (pre-pectoral breast reconstruction evaluation)","aka":["Pre-BRA study"],"tldr":"Putting the implant in front of the chest muscle rather than behind it was adopted across Britain on the argument that it hurts less and looks better. This study followed the first 347 women and found the implant was lost about as often as with the older technique, and that physical and sexual wellbeing were worse than before surgery at both three and eighteen months.","summary":"Pre-BRA is a prospective cohort at the second and third stages of the IDEAL framework for surgical innovation, designed to establish whether pre-pectoral reconstruction was safe and stable enough to justify a randomised trial. 347 women had 424 immediate implant-based reconstructions at 40 United Kingdom centres between July 2019 and December 2020, most of them single-stage direct-to-implant (357, 84.2 percent) and mesh-assisted (341, 80.4 percent). Four patients (0.9 percent) had to be converted to a sub-pectoral reconstruction during the operation because the skin flap was too poor.\n\nAt three months, 144 of the 343 women who had pre-pectoral reconstruction (42.0 percent) had at least one complication: 28 (8.2 percent) lost the implant, 67 (19.5 percent) had an infection, 60 (17.5 percent) were readmitted and 55 (16.0 percent) needed a reoperation. Implant loss is comparable to the sub-pectoral mesh-assisted technique measured by iBRA.\n\nThe patient-reported analysis, published in 2025 and covering 338 of 343 women (98.5 percent), is the part worth reading before consenting. Against their own scores before surgery, women reported statistically significant and clinically meaningful falls in both physical and sexual wellbeing at three and at eighteen months. Two-thirds (167 of 251) rated the result excellent or very good; major complications, implant loss and dissatisfaction with visible wrinkling or rippling were what reduced satisfaction.\n\nThe authors' conclusion is a statement about consent rather than about technique: these findings should be discussed with patients so that expectations are realistic.","status":"completed","asOf":"2026-09-25","links":[{"label":"ISRCTN11898000","url":"https://www.isrctn.com/ISRCTN11898000"},{"label":"Pre-BRA three-month safety (British Journal of Surgery 2022)","url":"https://doi.org/10.1093/bjs/znac077"},{"label":"Pre-BRA patient-reported outcomes at 3 and 18 months (British Journal of Surgery 2025)","url":"https://doi.org/10.1093/bjs/znaf032"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["breast-reconstruction","mastectomy","body-image-after-breast-surgery"],"trials":["ibra-study","best-bra"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN11898000","phase":"observational","setting":"Immediate pre-pectoral implant-based breast reconstruction after mastectomy for cancer or risk reduction at 40 United Kingdom centres: implant loss at three months, and patient-reported outcomes on the BREAST-Q at three and eighteen months","sponsor":"University of Bristol, with the Association of Breast Surgery","result":"Implant loss 8.2 percent at three months and a complication in 42.0 percent; physical and sexual wellbeing fell significantly against baseline at three and eighteen months, and two-thirds rated the outcome excellent or very good.","yearReported":2025,"enrolled":347,"enrolledBasis":"registry","outcomes":[{"endpoint":"Implant loss within 3 months","primary":true,"unit":"%","arms":[{"name":"Immediate pre-pectoral implant-based reconstruction","n":343,"value":8.2,"note":"28 women"}],"source":"https://doi.org/10.1093/bjs/znac077"},{"endpoint":"Any complication within 3 months","unit":"%","arms":[{"name":"Immediate pre-pectoral implant-based reconstruction","n":343,"value":42,"note":"144 women"}],"source":"https://doi.org/10.1093/bjs/znac077"}],"replication":"iBRA measured the same short-term endpoints across all implant techniques in 2,081 patients and found implant loss of 9 percent."},{"id":"nct05868226","kind":"trial","name":"PRE-ISPY Phase I/II Oncology Platform Program","aka":["PRE-ISPY"],"tldr":"A phase 1/2 trial of evorpacept, zanidatamab and tucatinib in colorectal cancer, run by QuantumLeap Healthcare Collaborative, now recruiting.","summary":"PRE-ISPY Phase I/II Oncology Platform Program is a phase 1/2, interventional study registered as NCT05868226 by QuantumLeap Healthcare Collaborative, with a registry enrolment figure of 280 participants, started 2023-02-15 and due to reach its primary completion in 2030-12-30. Interventions recorded: ALX148; Fam-Trastuzumab Deruxtecan-Nxki; Zanidatamab; Tucatinib; TTX-MC138. Conditions listed: HER2-positive Breast Cancer; Metastatic Cancer; Metastatic Breast Cancer; Metastatic; HER2-positive Metastatic Breast Cancer; HER2 Mutation-Related Tumors; HER-2 Protein Overexpression; HER2-negative Breast Cancer; Triple Negative Breast Cancer; HR Positive; Hormone Receptor-positive Breast Cancer; Estrogen Receptor Positive Tumor; Progesterone Receptor-positive Breast Cancer; Hormone Receptor Negative Breast Carcinoma; Solid Tumor; Solid Tumor, Adult; Solid Carcinoma; HER2 Low Breast Cancer; HER2 Low Breast Carcinoma; ER Positive Breast Cancer; PR-positive Breast Cancer; Minimal Residual Disease; Colo-rectal Cancer; Colon Cancer; Rectal Cancer; ctDNA Monitoring; Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Neoplasm, Residual; Adenocarcinoma of Colon; Adenocarcinoma. Primary outcome: Incidence of Adverse Events related to the treatment; For Phase Ib Part 1 study design: Incidence of Dose Limiting Toxicities (DLTs) at each dose level; For select drug arms, Maximum Tolerated Dose (MTD). Colorectal eligibility wording from the registry: \"Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before enrollment, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05868226","url":"https://clinicaltrials.gov/study/NCT05868226"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","her2-amplified-colorectal"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","kinase-inhibitors","mrd-testing"],"targets":[],"drugs":["evorpacept","zanidatamab","tucatinib"],"companies":["alx-oncology","jazz"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05868226","phase":"1/2","setting":"PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/II Platform Trial","sponsor":"QuantumLeap Healthcare Collaborative","started":"2023-02-15","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05845450","kind":"trial","name":"Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)","aka":["UNICORN"],"tldr":"A phase 2 trial of trastuzumab deruxtecan, durvalumab, panitumumab, botensilimab and other drugs in colorectal cancer, run by Gruppo Oncologico del Nord-Ovest, now recruiting.","summary":"Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) is a phase 2, interventional study registered as NCT05845450 by Gruppo Oncologico del Nord-Ovest, with a registry enrolment figure of 197 participants, started 2023-05-11 and due to reach its primary completion in 2027-05. Interventions recorded: Trastuzumab deruxtecan; Durvalumab; Panitumumab; Botensilimab; Balstilimab; Sotorasib; Vorbipiprant; Nivolumab; Amivantamab; Botensilimab; Balstilimab. Conditions listed: Colorectal Cancer; Resectable Colorectal Carcinoma. Primary outcome: major pathological response rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed colorectal cancer adenocarcinoma that is judged as initially resectable with elective surgery aimed at radical intent with R0 margins as per multidisciplinary team assessment\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05845450","url":"https://clinicaltrials.gov/study/NCT05845450"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor","kras-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["trastuzumab-deruxtecan","durvalumab","panitumumab","botensilimab","balstilimab","sotorasib","nivolumab","amivantamab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05845450","phase":"2","setting":"Window-of-opportunity Umbrella Platform Trial of Short-course Pre-operative Targeted Treatments in Patients With Molecularly Selected and Resectable Primary Colorectal Cancer: the UNICORN Study","sponsor":"Gruppo Oncologico del Nord-Ovest","started":"2023-05-11","startedType":"actual","enrolled":197,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06899477","kind":"trial","name":"Pre-Operative Treatment in REseCTable COlon CanceR","aka":["FIRE-10"],"tldr":"A phase 3 trial of FOLFOXIRI, fOLFOX (5-FU, leucovorin, oxaliplatin) and cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Dominik Paul Modest, not yet recruiting.","summary":"Pre-Operative Treatment in REseCTable COlon CanceR is a phase 3, randomised interventional study registered as NCT06899477 by Dominik Paul Modest, with a registry enrolment figure of 714 participants, started 2025-04 and due to reach its primary completion in 2033-04. Interventions recorded: mFOLFOXIRI; mFOLFOX-6; CAPOX. Conditions listed: Colo-rectal Cancer; Colon Cancer; Colon Carcinoma. Primary outcome: Disease-free survival (DFS). Colorectal eligibility wording from the registry: \"Histologically confirmed adenocarcinoma of the colon or upper rectum\". Sites: Germany. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06899477","url":"https://clinicaltrials.gov/study/NCT06899477"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfoxiri","folfox","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06899477","phase":"3","setting":"Pre-Operative Treatment in REseCTable COlon CanceR (PROTECTOR/FIRE-10; AIO-KRK-0620; IAG-VO-0323) Prospective, Randomized, Open, Multicenter Phase III Trial to Investigate the Efficacy Preoperative Systemic Therapy in Advanced Colon Cancer","sponsor":"Dominik Paul Modest","started":"2025-04","startedType":"estimated","enrolled":714,"enrolledBasis":"registry","outcomes":[]},{"id":"precede","kind":"trial","name":"PRECEDE","aka":["Pancreatic Cancer Early Detection Consortium"],"tldr":"PRECEDE is a very large international study following people whose genes or family history put them at high risk of pancreatic cancer, with yearly scans and stored blood samples, to find out how to catch the cancer early enough to cure it; it is still enrolling towards 20,000 participants.","summary":"PRECEDE (the Pancreatic Cancer Early Detection Consortium) is a prospective observational cohort registered by Arbor Research Collaborative for Health and run across more than 40 academic centres. It enrols people at high risk of pancreatic ductal adenocarcinoma, including carriers of germline pathogenic variants, members of familial pancreatic cancer kindreds, people with pancreatic cysts and cohorts with new-onset diabetes, in defined cohorts with protocol-driven surveillance imaging and longitudinal biospecimen collection. The primary outcome is the development of pancreatic ductal adenocarcinoma; the consortium's stated aim is to raise five-year survival by detecting the disease at a curable stage.\n\nThe registry lists an estimated 20,000 participants with completion in 2030 and no results. With the older CAPS programme it defines high-risk surveillance on the corpus's pancreatic cancer page.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04970056","url":"https://clinicaltrials.gov/study/NCT04970056"}],"tags":["soc-trials"],"related":[],"cancers":["pancreatic","ipmn-cystic-precursors"],"sections":[],"technologies":["pancreatic-surveillance"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-gonda-precede-consortium-recommendations-gastroenterology-2021","paper-worthington-precede-early-detection-biomarkers-ijc-2026","paper-canto-caps-long-term-surveillance-gastroenterology-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04970056","phase":"observational","setting":"People at high risk of pancreatic cancer (germline pathogenic variants, familial pancreatic cancer kindreds, pancreatic cysts and new-onset diabetes cohorts) followed prospectively with imaging and biobanking across more than 40 centres, with the development of pancreatic ductal adenocarcinoma as the primary outcome","sponsor":"Arbor Research Collaborative for Health","started":"2020-09-18","startedType":"actual","enrolled":20000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06227065","kind":"trial","name":"Precise Chemoresection in Low-grade NMIBC Using Drug Screens in Patient-derived Organoids","aka":[],"tldr":"A phase 2 trial of Patient-derived organoids in Non-muscle-invasive bladder cancer, run by Hospital Centre Biel/Bienne, not yet recruiting.","summary":"Precise Chemoresection in Low-grade NMIBC Using Drug Screens in Patient-derived Organoids is a phase 2 interventional study registered as NCT06227065 by Hospital Centre Biel/Bienne, with 28 participants planned, started 2026-12-01 and due to reach its primary completion in 2030-11-30. Interventions recorded: Epirubicin, Mitomycin, Gemcitabine, Docetaxel. Conditions recorded: Bladder Cancer, Non-muscle Invasive Bladder Cancer, Low Grade.\n\nLinked to the technology Patient-derived organoids because the registry's title names it (\"patient derived organoids\") and Non-muscle-invasive bladder cancer among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06227065","url":"https://clinicaltrials.gov/study/NCT06227065"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["organoids"],"targets":[],"drugs":["epirubicin","gemcitabine","docetaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06227065","phase":"2","setting":"POLO-Trial. Precise Neoadjuvant Chemoresection of Low-grade NMIBC Guided by Drug Sceens in Patient-derived Or-ganoids. An Open-label, Phase II Trial.","sponsor":"Hospital Centre Biel/Bienne","started":"2026-12-01","startedType":"estimated","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05806060","kind":"trial","name":"Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer","aka":["BCTOP-T-M01"],"tldr":"A phase 3 trial in triple-negative breast cancer, run by Fudan University, now recruiting.","summary":"Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer is a phase 3, randomised interventional study registered as NCT05806060 by Fudan University, with a registry enrolment figure of 134 participants, started 2023-04-25 and due to reach its primary completion in 2026-05-01. Interventions recorded: VEGFR and TPC; TPC. Conditions listed: Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression) with BLIS subtype\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05806060","url":"https://clinicaltrials.gov/study/NCT05806060"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05806060","phase":"3","setting":"Precise Treatment for BLIS Subtype of Triple-negative Breast Cancer in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer","sponsor":"Fudan University","started":"2023-04-25","startedType":"actual","enrolled":134,"enrolledBasis":"registry","outcomes":[]},{"id":"precision-mri","kind":"trial","name":"PRECISION","aka":[],"tldr":"PRECISION proved that an MRI first finds more dangerous cancers with fewer biopsies.","summary":"PRECISION, trial NCT02380027 sponsored by UCL and reported in 2018, proved that doing an MRI first, and biopsying only if the scan is positive, finds more dangerous prostate cancers with fewer biopsies than standard transrectal ultrasound biopsy. It randomised 500 biopsy-naive men with a raised PSA, detected clinically significant cancer in 38 percent with MRI-targeted biopsy against 26 percent with standard biopsy, found fewer insignificant cancers and let 28 percent of men avoid biopsy, changing guidelines worldwide. OnCo links it to multiparametric prostate MRI, MRI-first screening, Mark Emberton and Hashim U. Ahmed, and to the bottleneck of overdiagnosis; its findings were confirmed by PRECISE, MRI-FIRST and the Göteborg-2 screening trial. Whether MRI-first pathways can be delivered at population scale with consistent reading quality is the open question.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT02380027","url":"https://clinicaltrials.gov/study/NCT02380027"}],"tags":[],"related":[],"cancers":["prostate","prostate-low-risk"],"sections":[],"technologies":["mp-mri"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["mark-emberton","hashim-ahmed"],"bottlenecks":[],"keyPapers":["paper-precision-mri-targeted-biopsy-nejm-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02380027","phase":"3","setting":"Biopsy-naive men with raised PSA: MRI-targeted biopsy (biopsy only if MRI positive) vs standard TRUS biopsy","sponsor":"UCL","result":"Clinically significant cancer 38% vs 26%.","started":"2016-01","yearReported":2018,"enrolled":500,"enrolledBasis":"registry","outcomes":[{"endpoint":"Detection of clinically significant cancer","primary":true,"unit":"%","arms":[{"name":"MRI-targeted biopsy","n":252,"value":38},{"name":"Standard TRUS biopsy","n":248,"value":26}],"p":"0.005","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1801993"}],"replication":"Confirmed by PRECISE, MRI-FIRST, and the Göteborg-2 screening trial."},{"id":"nct07729917","kind":"trial","name":"Precision Integrated Strategies and Efficacy Evaluation for Biliary Tract Cancers: An Umbrella Platform Study","aka":[],"tldr":"A phase 2 trial of gemcitabine and oxaliplatin in gallbladder cancer and other biliary tract cancers, run by Zhejiang University, not yet recruiting.","summary":"Precision Integrated Strategies and Efficacy Evaluation for Biliary Tract Cancers: An Umbrella Platform Study is a phase 2 interventional study registered as NCT07729917 by Zhejiang University, with a registry enrolment figure of 240 participants, started 2026-08-10 and due to reach its primary completion in 2028-08-31. Interventions recorded: FGFR Inhibitor, IDH1 mutation inhibitor, KRAS mutation inhibitor, NTRK mutation inhibitor, BRAF V600E mutation inhibitor, BRCA 1/2 mutation inhibitor, HER2 target therapy, Immune Checkpoint Inhibitors, Chemotherapy: GP/GEMOX. Conditions listed: Bile Duct Carcinoma, Cholangiocarcinoma. Gallbladder cancer is named in the registry entry: \"* Histologically or cytologically confirmed advanced biliary tract malignancies, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07729917","url":"https://clinicaltrials.gov/study/NCT07729917"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine","oxaliplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07729917","phase":"2","setting":"Precision Integrated Strategies and Efficacy Evaluation for Biliary Tract Cancers: An Umbrella Platform Study","sponsor":"Zhejiang University","started":"2026-08-10","startedType":"estimated","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"precision-promise","kind":"trial","name":"Precision Promise","aka":["Precision Promise trial","PanCAN Precision Promise","PRISM"],"tldr":"Precision Promise was the pancreatic cancer charity's attempt to copy I-SPY 2 for one of the cancers with the lowest survival: several new treatments tested at once against standard chemotherapy, with the trial itself learning which patients each helped. Its first two experimental drugs did not extend life, and the trial has closed.","summary":"Precision Promise was built by the Pancreatic Cancer Action Network with the statisticians behind I-SPY 2 and GBM AGILE and opened in January 2020 at a network of United States pancreatic cancer centres. Patients with metastatic pancreatic adenocarcinoma entering first- or second-line treatment were randomised adaptively between standard chemotherapy (gemcitabine with nab-paclitaxel or modified FOLFIRINOX) and experimental arms, with overall survival as the primary endpoint and a design that let a promising arm expand seamlessly into a registration-quality stage. Tumour and blood samples were collected to search for subgroups that responded.\n\nThe first experimental arm, SM-88 (racemetyrosine), was discontinued in 2022 for lack of efficacy. The second, pamrevlumab, an antibody against connective tissue growth factor given with chemotherapy, did not improve survival and was closed after its interim analysis. No further arms graduated, and the registry records the trial as completed with about 500 participants enrolled.\n\nPrecision Promise is the cautionary member of the platform family: the machinery worked, but a platform is only as good as the drugs offered to it, and pancreatic cancer had few strong candidates during the years it ran. It leaves a well-characterised control cohort and biobank, and lessons about how a disease charity can sponsor a registration-grade platform, that later pancreatic trials draw on.","status":"completed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04229004","url":"https://clinicaltrials.gov/study/NCT04229004"},{"label":"Pancreatic Cancer Action Network: Precision Promise","url":"https://pancan.org/research/precision-promise/"}],"tags":[],"related":["pancan"],"cancers":["pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["gemcitabine","folfirinox","pamrevlumab"],"companies":["fibrogen"],"institutions":[],"pathways":[],"terms":["master-protocol","seamless-adaptive","interim-analysis"],"trials":[],"people":[],"bottlenecks":["b-trial-design"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registry status on 24 September 2026: completed, 502 participants (actual), started 31 January 2020, primary completion 5 February 2025; arms included gemcitabine with nab-paclitaxel, modified FOLFIRINOX, pamrevlumab, canakinumab with spartalizumab and SM-88, with overall survival as the primary endpoint; United States sites only."],"nct":"NCT04229004","phase":"platform","setting":"Metastatic pancreatic ductal adenocarcinoma in first and second line: a Bayesian adaptive platform comparing experimental regimens with gemcitabine plus nab-paclitaxel or modified FOLFIRINOX on overall survival, with seamless graduation to a confirmatory stage","sponsor":"Pancreatic Cancer Action Network","result":"SM-88 discontinued in 2022 for lack of efficacy; pamrevlumab did not improve overall survival; the trial closed with about 500 participants.","started":"2020-01-31","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"precision-panc","kind":"trial","name":"Precision-Panc","aka":["Precision Panc master protocol","PRIMUS trials","ISRCTN14879538"],"tldr":"The UK precision medicine platform for pancreatic cancer, led from Glasgow: profile the tumour at diagnosis, then route the patient to a matching PRIMUS trial.","summary":"Precision-Panc, led by Andrew Biankin and sponsored by NHS Greater Glasgow and Clyde, opened its master protocol in December 2017. The ISRCTN record lists 27 recruiting sites from Glasgow Royal Infirmary and Aberdeen to the Royal Marsden, UCLH, Addenbrooke's, The Christie, Weston Park, Bristol, Imperial, Nottingham, the Royal Free, Ninewells, St George's, Southampton, Queen Elizabeth Birmingham, King's, the Churchill, Castle Hill, Poole, the Freeman and Bournemouth, a target of 5,000 and an end of recruitment on 29 March 2022; the registry shows it as suspended. Its PRIMUS trials (ISRCTN75002153 PRIMUS 001 first-line, ISRCTN34129115 PRIMUS 002 neoadjuvant, ISRCTN16004234 PRIMUS 004 second-line platform, ISRCTN53212600 PRIMUS 006, and STARPAC2 as PRIMUS 005) tested treatments matched to molecular subtype; PRIMUS 002, 004 and 006 are recorded as stopped and PRIMUS 001 as no longer recruiting. The programme's legacy is a UK network of centres able to take research biopsies and run molecular profiling at diagnosis.","status":"completed","asOf":"2026-09-24","links":[{"label":"ISRCTN14879538: Precision Panc","url":"https://www.isrctn.com/ISRCTN14879538"},{"label":"STARPAC2 protocol (PRIMUS 005), BMC Cancer 2025","url":"https://europepmc.org/article/MED/39833722"}],"tags":["uk","precision-medicine","platform","pancreatic"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":["targeted-therapy","diagnostics"],"technologies":[],"targets":["kras","brca"],"drugs":[],"companies":[],"institutions":["wolfson-wohl-cancer-research-centre","glasgow-royal-infirmary","beatson-glasgow","aberdeen-royal-infirmary","ninewells-dundee","hull-castle-hill","royal-marsden","uclh","addenbrookes-cambridge","the-christie","weston-park-sheffield","imperial-cancer-centre","nottingham-cancer-centre","royal-free-hospital","southampton-cancer","birmingham-cancer-centre","kings-college-hospital-london","oxford-cancer","newcastle-cancer-centre"],"pathways":[],"terms":["genomic-profiling"],"trials":[],"people":["andrew-biankin"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN14879538","phase":"platform","setting":"Master protocol taking extra tissue at diagnostic biopsy or a dedicated research biopsy from people with pancreatic cancer at 27 UK sites, for molecular profiling and allocation to the PRIMUS treatment trials; recruitment 14 December 2017 to 29 March 2022, target 5,000","sponsor":"NHS Greater Glasgow and Clyde","enrolled":5000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05316701","kind":"trial","name":"Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies","aka":["Precision-T"],"tldr":"A phase 3 trial of Orca-T in acute myeloid leukaemia and myelodysplastic syndromes / neoplasms, run by Orca Biosystems, Inc., active and no longer recruiting.","summary":"Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies is a phase 3 interventional study registered as NCT05316701 by Orca Biosystems, Inc., with 187 participants enrolled, started 2022-06-21 and due to reach its primary completion in 2024-07-15. Interventions recorded: Orca-T and Standard-of-Care. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05316701","url":"https://clinicaltrials.gov/study/NCT05316701"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","mds"],"sections":[],"technologies":["allogeneic-cell-therapy"],"targets":[],"drugs":["tregzi"],"companies":["orca-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05316701","phase":"3","setting":"A Randomized Phase III Trial of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation With Either Orca-T, a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells, or Standard-of-Care Allogeneic Graft","sponsor":"Orca Biosystems, Inc.","started":"2022-06-21","startedType":"actual","yearReported":2025,"enrolled":187,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free at 12 Months for Moderate or Severe Chronic Graft-versus-Host-Disease-free Survival (cGFS) Per Endpoint Adjudication Committee (EAC)","primary":true,"unit":"%","arms":[{"name":"Orca-T","n":93,"value":78,"note":"95% CI 65.0 to 86.6; Figures from the ClinicalTrials.gov results section (first posted 2025-09-26), not from a publication"},{"name":"Standard of Care","n":94,"value":38.4,"note":"95% CI 26.2 to 50.5"}],"hr":0.26,"ci":[0.14,0.47],"p":"<0.00001","source":"https://clinicaltrials.gov/study/NCT05316701?tab=results"},{"endpoint":"Event-free at 12 Months for Overall Survival (OS)","unit":"%","arms":[{"name":"Orca-T","n":93,"value":93.9,"note":"95% CI 85.8 to 97.4; Figures from the ClinicalTrials.gov results section (first posted 2025-09-26), not from a publication"},{"name":"Standard of Care","n":94,"value":83.1,"note":"95% CI 72.9 to 89.8"}],"hr":0.49,"ci":[0.2,1.22],"p":"0.11823","source":"https://clinicaltrials.gov/study/NCT05316701?tab=results"}]},{"id":"nct07069595","kind":"trial","name":"PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease","aka":["PREDICT-RD"],"tldr":"A phase 2 trial of datopotamab deruxtecan in triple-negative breast cancer, run by UNC Lineberger Comprehensive Cancer Center, now recruiting.","summary":"PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease is a phase 2, interventional study registered as NCT07069595 by UNC Lineberger Comprehensive Cancer Center, with a registry enrolment figure of 78 participants, started 2026-02-26 and due to reach its primary completion in 2031-11-01. Interventions recorded: Datopotamab deruxtecan; Circulating tumor DNA (ctDNA) testing. Conditions listed: Breast Cancer; Residual Disease; Triple Negative Breast Cancer (TNBC); Stage II/III. Triple-negative eligibility wording from the registry: \"* Histological confirmation of TNBC defined by ER/PR \\<10%, HER2 0-1+ by IHC or 2+ by IHC and fluorescence in situ hybridization (FISH) negative\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07069595","url":"https://clinicaltrials.gov/study/NCT07069595"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["datopotamab-deruxtecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07069595","phase":"2","setting":"PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC With Residual Disease","sponsor":"UNC Lineberger Comprehensive Cancer Center","started":"2026-02-26","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"preempt-crc","kind":"trial","name":"PREEMPT CRC","aka":["FRNM-004","Prevention of Colorectal Cancer Through Multiomics Blood Testing"],"tldr":"The study behind the second approved blood test for bowel cancer screening: the test found about four in five cancers and kept false alarms low, but like Shield it missed most advanced polyps, which is why guidelines still rank blood tests below colonoscopy and stool tests.","summary":"PREEMPT CRC (NCT04369053; organisation id FRNM-004) was a prospective, multicentre, cross-sectional observational study of Freenome's investigational blood-based circulating tumour DNA and protein test for colorectal cancer screening. Asymptomatic average-risk adults aged 45 to 85 had blood drawn before a standard-of-care screening colonoscopy at 201 centres across 49 US states and the United Arab Emirates between May 2020 and April 2022. Participants, staff and pathologists were blinded to the blood test result, and laboratory testing was blinded to colonoscopy findings. The primary endpoints were sensitivity for colorectal cancer and specificity, negative predictive value and positive predictive value for advanced colorectal neoplasia; the secondary endpoint was sensitivity for advanced precancerous lesions.\n\nIn the evaluable cohort of 27,010 participants (JAMA 2025), sensitivity for colorectal cancer was 79.2 percent (57 of 72; 95 percent CI 68.4 to 86.9) and specificity for advanced colorectal neoplasia was 91.5 percent (22,306 of 24,371; 91.2 to 91.9). Negative and positive predictive values for advanced colorectal neoplasia were 90.8 percent and 15.5 percent. All primary endpoints met their prespecified acceptance criteria. Sensitivity for advanced precancerous lesions was 12.5 percent (321 of 2,567; 11.3 to 13.8) and did not meet its acceptance criterion.\n\nClinicalTrials.gov lists an actual enrolment of 48,995 for the completed study. The FDA approved the test as SimpleScreen CRC on 24 July 2026 for average-risk adults aged 45 and older; Abbott holds US commercial rights. The registry study type is observational, which is why the interventional phase 2 and 3 pass never attached it to the product.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04369053","url":"https://clinicaltrials.gov/study/NCT04369053"},{"label":"JAMA 2025","url":"https://doi.org/10.1001/jama.2025.7515"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["colorectal-screening","liquid-biopsy","methylation-profiling"],"targets":[],"drugs":["simplescreen-crc"],"companies":["freenome"],"institutions":[],"pathways":[],"terms":["cfdna","sensitivity-specificity","screening"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-preempt-crc-shaukat-jama-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04369053","phase":"observational","setting":"Prospective cross-sectional validation of the Freenome cell-free DNA and protein blood test against screening colonoscopy in asymptomatic average-risk adults aged 45 to 85","sponsor":"Freenome Holdings","result":"Sensitivity 79.2% for colorectal cancer and specificity 91.5% for advanced colorectal neoplasia (n = 27,010 evaluable); all primary endpoints met; advanced precancerous lesion sensitivity 12.5% did not meet its criterion.","started":"2020-05-20","startedType":"actual","yearReported":2025,"enrolled":48995,"enrolledBasis":"registry","outcomes":[{"endpoint":"Sensitivity for colorectal cancer","primary":true,"unit":"%","arms":[{"name":"Freenome blood test (SimpleScreen CRC)","n":27010,"value":79.2,"note":"57 of 72 cancers; 95% CI 68.4 to 86.9"}],"source":"https://doi.org/10.1001/jama.2025.7515"},{"endpoint":"Specificity for advanced colorectal neoplasia","primary":true,"unit":"%","arms":[{"name":"Freenome blood test (SimpleScreen CRC)","n":27010,"value":91.5,"note":"22,306 of 24,371; 95% CI 91.2 to 91.9"}],"source":"https://doi.org/10.1001/jama.2025.7515"},{"endpoint":"Sensitivity for advanced precancerous lesions (secondary)","unit":"%","arms":[{"name":"Freenome blood test (SimpleScreen CRC)","n":27010,"value":12.5,"note":"321 of 2,567; 95% CI 11.3 to 13.8; did not meet the prespecified acceptance criterion"}],"source":"https://doi.org/10.1001/jama.2025.7515"}],"replication":"ECLIPSE (Shield, Guardant) reported 83 percent cancer sensitivity and 13 percent advanced-adenoma sensitivity for the first approved blood test in the same setting, so the two studies agree that blood tests find most cancers and few advanced polyps."},{"id":"prehab-trial","kind":"trial","name":"PREHAB: multimodal prehabilitation before colorectal cancer surgery","aka":[],"tldr":"PREHAB showed that four weeks of supervised training, protein and support before bowel cancer surgery cut severe complications and sped recovery, in an international randomised trial of 251 patients.","summary":"PREHAB was an international multicentre randomised trial (Netherlands, Denmark, Canada, Italy) registered in the Netherlands Trial Register (NTR5947). Patients in the prehabilitation arm had a lower rate of severe complications (Comprehensive Complication Index over 20) and about half the number of medical complications, with faster functional recovery and no delay in surgery attributable to the programme. The intervention was resource-intensive (three supervised sessions a week for four weeks) and adherence was high in a trial setting. It is the strongest single randomised result for prehabilitation, complementing meta-analyses that show consistent improvements in functional capacity but heterogeneous effects on complications, and it underpins national programmes such as NHS England's with Macmillan.","status":"positive","asOf":"2026-09-08","links":[{"label":"Molenaar et al. (JAMA Surg 2023)","url":"https://doi.org/10.1001/jamasurg.2023.0198"}],"tags":[],"related":["idea-bio2-prehabilitation-standard","idea-acc-prehabilitation-older-surgery"],"cancers":["colorectal"],"sections":["nutrition-lifestyle","surgery"],"technologies":["prehabilitation","eras-perioperative-nutrition","exercise-oncology","oncology-nutrition"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["prehabilitation-term","malnutrition-screening"],"trials":[],"people":[],"bottlenecks":["b-surgery-radiation-innovation","b-care-fragmentation"],"keyPapers":["paper-molenaar-jama-surg"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Non-metastatic colorectal cancer scheduled for elective resection within an ERAS pathway: 4-week supervised multimodal prehabilitation (high-intensity exercise, nutrition, psychological support, smoking cessation) vs ERAS alone","sponsor":"Maastricht University Medical Centre and international consortium","result":"Fewer severe complications and faster recovery with prehabilitation; surgery not delayed.","yearReported":2023,"enrolled":251,"enrolledBasis":"registry","outcomes":[{"endpoint":"Severe postoperative complications (Comprehensive Complication Index > 20)","primary":true,"unit":"%","arms":[{"name":"Multimodal prehabilitation","n":123,"value":17.1,"note":"Odds ratio 0.47 (95% CI 0.26-0.87)"},{"name":"Standard care (ERAS)","n":128,"value":29.7}],"p":"0.02","source":"https://doi.org/10.1001/jamasurg.2023.0198"},{"endpoint":"Medical complications","unit":"%","arms":[{"name":"Multimodal prehabilitation","value":15.4,"note":"Odds ratio 0.48 (95% CI 0.26-0.89)"},{"name":"Standard care (ERAS)","value":27.3}],"p":"0.02","source":"https://doi.org/10.1001/jamasurg.2023.0198"},{"endpoint":"6-minute walking distance at 4 weeks post-operatively (change from baseline)","primary":true,"arms":[{"name":"Multimodal prehabilitation","note":"Mean difference 15.6 m (95% CI -1.4 to 32.6); not significant. Trial stopped early because of COVID-19."},{"name":"Standard care (ERAS)"}],"p":"0.07","source":"https://doi.org/10.1001/jamasurg.2023.0198"}],"replication":"Largest multicentre prehabilitation RCT; consistent in direction with the earlier Montreal single-centre trials, though the functional-capacity co-primary endpoint was not met and the trial stopped early, so the complication effect awaits replication."},{"id":"nct05663866","kind":"trial","name":"Premedication to Reduce Amivantamab Associated Infusion Related Reactions","aka":[],"tldr":"A phase 2 trial of Dexamethasone, Methotrexate, Amivantamab and Lazertinib in non-small-cell lung cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"Premedication to Reduce Amivantamab Associated Infusion Related Reactions is a phase 2 interventional study registered as NCT05663866 by Janssen Research & Development, LLC, with 68 participants enrolled, started 2023-05-18 and due to reach its primary completion in 2024-03-29. Interventions recorded: Dexamethasone, Montelukast, Methotrexate, Amivantamab and Lazertinib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05663866","url":"https://clinicaltrials.gov/study/NCT05663866"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["antiemetic-therapy","bispecific-antibody","cytotoxic-chemotherapy"],"targets":[],"drugs":["dexamethasone","methotrexate","amivantamab","lazertinib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05663866-j-thorac-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05663866","phase":"2","setting":"Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study","sponsor":"Janssen Research & Development, LLC","started":"2023-05-18","startedType":"actual","yearReported":2025,"enrolled":68,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1","primary":true,"unit":"%","arms":[{"name":"Cohort A: Dexamethasone 4 Milligrams (mg)","n":6,"value":83.3,"note":"95% CI 35.9 to 99.6; Figures from the ClinicalTrials.gov results section (first posted 2025-10-20), not from a publication"},{"name":"Cohort A2: Dexamethasone 8 mg","n":40,"value":22.5,"note":"95% CI 10.8 to 38.5"},{"name":"Cohort B: Montelukast 10 mg","n":15,"value":66.7,"note":"95% CI 38.4 to 88.2"},{"name":"Cohort C: Methotrexate 25 mg","n":6,"value":83.3,"note":"95% CI 35.9 to 99.6"}],"source":"https://clinicaltrials.gov/study/NCT05663866?tab=results"}]},{"id":"preopanc","kind":"trial","name":"PREOPANC-1","aka":["PREOPANC","PREOPANC-1","PREOPANC 1"],"tldr":"The Dutch trial testing whether treating before surgery beats operating first. Chemoradiation first fell short at the primary analysis but won at five years, with one in five patients alive against one in fifteen.","summary":"PREOPANC-1 randomised 246 patients between 2013 and 2017. The primary analysis (JCO 2020) gave median OS 16.0 vs 14.3 months (HR 0.78, p 0.096), short of significance, with a higher R0 resection rate (71% vs 40%) and better disease-free survival; the long-term analysis (JCO 2022, median follow-up 59 months) gave HR 0.73 (p 0.025) and 5-year OS 20.5% vs 6.5%, consistent in resectable and borderline patients. Its successor PREOPANC-2 (Lancet Oncology 2025) found neoadjuvant FOLFIRINOX no better than this regimen (21.9 vs 21.3 months), and PREOPANC-3 and ALLIANCE A021806 now test perioperative against adjuvant mFOLFIRINOX, while NORPACT-1 argued against neoadjuvant treatment for clearly resectable tumours; borderline-resectable disease is generally treated neoadjuvantly.","status":"mixed","asOf":"2026-09-06","links":[{"label":"PREOPANC-1 primary analysis, JCO 2020 (NTR3709)","url":"https://doi.org/10.1200/JCO.19.02274"},{"label":"PREOPANC-1 long-term results, JCO 2022","url":"https://doi.org/10.1200/JCO.21.02233"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac","borderline-resectable-pdac"],"sections":[],"technologies":["imrt-igrt","chemoradiation"],"targets":[],"drugs":["gemcitabine"],"companies":["dpcg"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","chemoradiation"],"trials":["preopanc-2","preopanc-3","norpact-1","alliance-a021806"],"people":["marc-besselink"],"bottlenecks":[],"keyPapers":["paper-preopanc-preoperative-chemoradiotherapy-jco-2020"],"journals":[],"dependsOn":[],"notes":["PREOPANC-1 design (JCO 2020): 246 patients at 16 Dutch centres randomised between April 2013 and July 2017 to three cycles of gemcitabine with 36 Gy in 15 fractions during the second, surgery and four adjuvant cycles, or immediate surgery and six adjuvant cycles. Primary analysis: median overall survival 16.0 against 14.3 months (hazard ratio 0.78; p 0.096), resection rate 61 against 72 percent, R0 rate 71 against 40 percent, serious adverse events 52 against 41 percent. Long-term analysis (JCO 2022, median follow-up 59 months): hazard ratio 0.73 (0.56 to 0.96; p 0.025), median 15.7 against 14.3 months, five-year survival 20.5 against 6.5 percent, consistent in resectable and borderline subgroups. PREOPANC-2 (2025) then compared neoadjuvant FOLFIRINOX with this regimen and found no difference (21.9 against 21.3 months)."],"nct":"NTR3709","phase":"3","setting":"Resectable and borderline-resectable PDAC at 16 Dutch centres: neoadjuvant gemcitabine-based chemoradiation (36 Gy in 15 fractions), surgery and adjuvant gemcitabine vs upfront surgery and adjuvant gemcitabine","sponsor":"Dutch Pancreatic Cancer Group","result":"5-year OS 20.5% vs 6.5% (HR 0.73, p 0.025); primary analysis median OS 16.0 vs 14.3 months (HR 0.78, p 0.096).","yearReported":2022,"enrolled":246,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (long-term)","primary":true,"unit":"%","arms":[{"name":"Neoadjuvant chemoradiotherapy, 5-year OS","n":119,"value":20.5},{"name":"Upfront surgery, 5-year OS","n":127,"value":6.5}],"hr":0.73,"ci":[0.56,0.96],"p":"0.025","source":"https://ascopubs.org/doi/10.1200/JCO.21.02233"},{"endpoint":"Overall survival (primary analysis, intention to treat)","unit":"months","arms":[{"name":"Neoadjuvant gemcitabine chemoradiotherapy, surgery, adjuvant gemcitabine","n":119,"value":16},{"name":"Upfront surgery, adjuvant gemcitabine","n":127,"value":14.3}],"hr":0.78,"ci":[0.58,1.05],"p":"0.096","source":"https://doi.org/10.1200/JCO.19.02274"},{"endpoint":"R0 resection rate among resected patients","unit":"%","arms":[{"name":"Neoadjuvant chemoradiotherapy","n":72,"value":71,"note":"51 of 72"},{"name":"Upfront surgery","n":92,"value":40,"note":"37 of 92"}],"p":"<0.001","source":"https://doi.org/10.1200/JCO.19.02274"}],"replication":"Supported by PREOPANC-2 and ALLIANCE A021806 in favour of neoadjuvant therapy in (borderline) resectable disease."},{"id":"preopanc-2","kind":"trial","name":"PREOPANC-2","aka":["PREOPANC 2"],"tldr":"PREOPANC-2 asked whether the strongest chemotherapy given entirely before surgery beats the Dutch standard of gemcitabine chemoradiotherapy before and gemcitabine after; survival was the same, about 22 months in both arms, so both remain reasonable ways to treat first, and the question of surgery first against treatment first moves to Alliance A021806 and PREOPANC-3.","summary":"PREOPANC-2 randomised 375 patients with resectable or borderline resectable pancreatic ductal adenocarcinoma and WHO performance status 0 or 1 to total neoadjuvant FOLFIRINOX (eight two-weekly cycles, surgery, no adjuvant treatment) or the PREOPANC-1 regimen of neoadjuvant gemcitabine-based chemoradiotherapy, surgery and adjuvant gemcitabine. After a median follow-up of 42.3 months, median overall survival was 21.9 months (95 percent confidence interval 17.7 to 27.0) with FOLFIRINOX against 21.3 months (16.8 to 25.5) with chemoradiotherapy (hazard ratio 0.88, 0.69 to 1.13; p 0.32). Grade 3 or 4 neutropenia was 25 against 22 percent, diarrhoea 23 against 1 percent and leucopenia 8 against 15 percent; serious adverse events 49 against 43 percent; three treatment-related deaths. The trial did not show a difference and the authors concluded that either neoadjuvant regimen may be used. Read with PREOPANC-1 (chemoradiotherapy first beat surgery first at five years) it supports treating before surgery in this Dutch population, while NORPACT-1 argues the opposite for clearly resectable tumours.","status":"negative","asOf":"2026-09-24","links":[{"label":"Janssen et al., PREOPANC-2 (Lancet Oncology 2025)","url":"https://doi.org/10.1016/S1470-2045(25)00363-8"},{"label":"EU Clinical Trials Register 2017-002036-17","url":"https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-002036-17"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac","borderline-resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","chemoradiation","hypofractionated-radiotherapy"],"targets":[],"drugs":["folfirinox","gemcitabine"],"companies":[],"institutions":["erasmus-mc"],"pathways":[],"terms":["neoadjuvant-adjuvant","chemoradiation"],"trials":[],"people":["marc-besselink"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Resectable and borderline resectable pancreatic ductal adenocarcinoma in the Netherlands: eight cycles of neoadjuvant FOLFIRINOX and surgery without adjuvant treatment, against three cycles of neoadjuvant gemcitabine with 36 Gy in 15 fractions during the second, surgery and four cycles of adjuvant gemcitabine, with overall survival as the primary endpoint","sponsor":"Dutch Pancreatic Cancer Group (Erasmus MC), Dutch Cancer Society and ZonMw","result":"Median overall survival 21.9 months with neoadjuvant FOLFIRINOX against 21.3 months with neoadjuvant gemcitabine chemoradiotherapy and adjuvant gemcitabine (hazard ratio 0.88, 95 percent confidence interval 0.69 to 1.13; p 0.32).","yearReported":2025,"enrolled":375,"enrolledBasis":"randomised","enrolledNote":"PREOPANC-2 is registered with EudraCT (2017-002036-17) and has no ClinicalTrials.gov record; 375 patients were randomised at 19 Dutch centres between June 2018 and January 2021 and 369 formed the modified intention-to-treat population.","outcomes":[{"endpoint":"Overall survival (modified intention to treat)","primary":true,"unit":"months","arms":[{"name":"Neoadjuvant FOLFIRINOX, surgery","n":185,"value":21.9,"note":"95% CI 17.7 to 27.0"},{"name":"Neoadjuvant gemcitabine chemoradiotherapy, surgery, adjuvant gemcitabine","n":184,"value":21.3,"note":"95% CI 16.8 to 25.5"}],"hr":0.88,"ci":[0.69,1.13],"p":"0.32","source":"https://doi.org/10.1016/S1470-2045(25)00363-8"}]},{"id":"preopanc-3","kind":"trial","name":"PREOPANC-3","aka":["PREOPANC 3"],"tldr":"PREOPANC-3 is the European twin of Alliance A021806: the same modified FOLFIRINOX given either around surgery or only afterwards for operable pancreatic cancer. Recruitment of 378 patients has closed and the first results are expected after the January 2027 primary completion date.","summary":"PREOPANC-3 (protocol in BMC Cancer 2023) randomises patients with resectable pancreatic cancer to perioperative or adjuvant modified FOLFIRINOX with overall survival as the primary endpoint; ClinicalTrials.gov on 24 September 2026 lists it as active but no longer recruiting, 378 participants (estimated), started 7 September 2021, primary completion January 2027 and completion July 2029, at sites in the Netherlands and Sweden. It follows PREOPANC-1 (neoadjuvant chemoradiotherapy beat upfront surgery at five years) and PREOPANC-2 (neoadjuvant FOLFIRINOX equal to neoadjuvant chemoradiotherapy), and with A021806 it will answer the surgery-first question that NORPACT-1 answered against neoadjuvant treatment in a smaller Nordic trial.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04927780","url":"https://clinicaltrials.gov/study/NCT04927780"},{"label":"PREOPANC-3 protocol (BMC Cancer 2023)","url":"https://doi.org/10.1186/s12885-023-11141-5"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["folfirinox"],"companies":[],"institutions":["erasmus-mc"],"pathways":[],"terms":["neoadjuvant-adjuvant","pancreatic-trials-open-today"],"trials":["alliance-a021806","preopanc","preopanc-2"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04927780","phase":"3","setting":"Resectable pancreatic ductal adenocarcinoma in the Netherlands and Sweden: perioperative modified FOLFIRINOX (eight cycles before surgery, four after) against upfront surgery and twelve adjuvant cycles, with overall survival as the primary endpoint","sponsor":"Erasmus Medical Center, Dutch Pancreatic Cancer Group and Dutch Cancer Society","started":"2021-09-07","startedType":"actual","enrolled":378,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06784791","kind":"trial","name":"Preoperative Amivantamab or Amivantamab and Carboplatin/Pemetrexed Treatment in Patients With Resectable Non-small-cell Lung Cancer Harboring Oncogenic EGFR Mut","aka":["NEOpredict-EGF"],"tldr":"A phase 2 trial of carboplatin and pemetrexed in lung cancer, run by University Hospital, Essen, now recruiting.","summary":"Preoperative Amivantamab or Amivantamab and Carboplatin/Pemetrexed Treatment in Patients With Resectable Non-small-cell Lung Cancer Harboring Oncogenic EGFR Mutations (NEOpredict-EGFR) is a phase 2, interventional study registered as NCT06784791 by University Hospital, Essen, with a registry enrolment figure of 20 participants, started 2024-11-06 and due to reach its primary completion in 2027-07-31. Interventions recorded: Amivantamab Intravenous; Carboplatin/Pemetrexed. Conditions listed: Lung Cancer (NSCLC). Primary outcome: Feasibility of one cycle of preoperative amivantamab therapy. Lung eligibility wording from the registry: \", bronchoscopy-guided biopsy) confirmed non-small-cell lung cancer (NSCLC) eligible for anatomic resection, with the following specifications:\". Sites: Belgium, Germany, Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06784791","url":"https://clinicaltrials.gov/study/NCT06784791"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06784791","phase":"2","setting":"Preoperative Amivantamab or Amivantamab and Carboplatin/Pemetrexed Treatment in Patients With Resectable Non-small-cell Lung Cancer Harboring Oncogenic EGFR Mutations (NEOpredict-EGFR)","sponsor":"University Hospital, Essen","started":"2024-11-06","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06751394","kind":"trial","name":"Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer","aka":["TRACER"],"tldr":"A phase 2 trial of capecitabine, fOLFOX (5-FU, leucovorin, oxaliplatin) and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, not yet recruiting.","summary":"Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer is a phase 2, interventional study registered as NCT06751394 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 44 participants, started 2025-01-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: PD-1 antibody (Toripalimab); Capecitabine; Oxaliplatin; Irinotecan; Radiation; surgery. Conditions listed: Recurrent Rectal Cancer. Primary outcome: Pathological complete response rate. Colorectal eligibility wording from the registry: \"Active inflammatory bowel disease or other colorectal diseases that lead to chronic diarrhea\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06751394","url":"https://clinicaltrials.gov/study/NCT06751394"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["capecitabine","folfox","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06751394","phase":"2","setting":"Preoperative Treatment with Radiotherapy and Anti-PD1 for Resectable Recurrent Rectal Cancer (TRACER)","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2025-01-01","startedType":"estimated","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06450574","kind":"trial","name":"Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Ttransanal Endoscopic Microsurgery in T1 N0, M0 Rectal Cancer (TAUTEM-T1 Study)","aka":["TAUTEM-T1"],"tldr":"A phase 3 trial of capecitabine in colorectal cancer, run by Corporacion Parc Tauli, not yet recruiting.","summary":"Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Ttransanal Endoscopic Microsurgery in T1 N0, M0 Rectal Cancer (TAUTEM-T1 Study) is a phase 3, randomised interventional study registered as NCT06450574 by Corporacion Parc Tauli, with a registry enrolment figure of 106 participants, started 2024-10 and due to reach its primary completion in 2026-10. Interventions recorded: Capecitabine (Xeloda); 50.4 Gy; Transanal Endoscopic Microsurgery (TEM); Transanal Endoscopic Microsurgery. Conditions listed: Rectal Cancer Stage I. Primary outcome: Rectal preservation in T1,N0,M0 rectal cancer; Total mesorectal excision in T1,N0,M0 rectal cancer. Colorectal eligibility wording from the registry: \"* Rectal adenocarcinomas in the biopsy, located at a distance from the anal margin less than or equal to 10 cm measured by rigid rectoscopy at the time of ER\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06450574","url":"https://clinicaltrials.gov/study/NCT06450574"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06450574","phase":"3","setting":"Prospective, Controlled and Randomized Phase III Multicentric Study of the Treatment of T1,N0,M0 Rectal Cancer. Neoadjuvant Therapy and Transanal Endoscopic Surgery vs. Transanal Endoscopic Surgery (TAUTEM-T1 Study)","sponsor":"Corporacion Parc Tauli","started":"2024-10","startedType":"estimated","enrolled":106,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05136326","kind":"trial","name":"Preoperative Chemoradiotherapy With CApecitabine and Temozolomide in MGMT Silenced, MSS, Locally Advanced RecTal Cancer","aka":["CATARTIC"],"tldr":"A phase 2 trial of capecitabine and temozolomide in colorectal cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, now recruiting.","summary":"Preoperative Chemoradiotherapy With CApecitabine and Temozolomide in MGMT Silenced, MSS, Locally Advanced RecTal Cancer is a phase 2, interventional study registered as NCT05136326 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, with a registry enrolment figure of 21 participants, started 2021-12-01 and due to reach its primary completion in 2023-12. Interventions recorded: External-beam radiation; Capecitabine; Temozolomide. Conditions listed: Rectal Cancer. Primary outcome: To evaluate the rate of complete pathologic response (pCR). Colorectal eligibility wording from the registry: \"* Histologically confirmed diagnosis of rectal adenocarcinoma, with centrally confirmed mismatch repair proficiency (MSS) by PCR, lack of MGMT expression by IHC and MGMT promoter methylation by pyrosequencing;\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05136326","url":"https://clinicaltrials.gov/study/NCT05136326"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["capecitabine","temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05136326","phase":"2","setting":"Multicenter Phase II Study of Preoperative Chemoradiotherapy With CApecitabine Plus Temozolomide in Patients With MGMT Silenced and Microsatellite Stable Locally Advanced RecTal Cancer: the CATARTIC Trial","sponsor":"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","started":"2021-12-01","startedType":"actual","enrolled":21,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07276880","kind":"trial","name":"Preoperative Chemotherapy, Pembrolizumab and Low or High Dose RADiation in an Expansion Cohort of Node(+), Triple Negative Breast Cancer","aka":["P-RAD(+)TN-DCT"],"tldr":"A phase 2 trial in triple-negative breast cancer, run by UNC Lineberger Comprehensive Cancer Center, now recruiting.","summary":"Preoperative Chemotherapy, Pembrolizumab and Low or High Dose RADiation in an Expansion Cohort of Node(+), Triple Negative Breast Cancer is a phase 2, randomised interventional study registered as NCT07276880 by UNC Lineberger Comprehensive Cancer Center, with a registry enrolment figure of 32 participants, started 2026-03-17 and due to reach its primary completion in 2027-11. Interventions recorded: Neoadjuvant Pembrolizumab; low dose neoadjuvant boost; High dose neoadjuvant boost. Conditions listed: Breast Cancer; Triple Negative Breast Cancer (TNBC); HER2-Negative Breast Carcinoma; Node-positive Breast Cancer. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07276880","url":"https://clinicaltrials.gov/study/NCT07276880"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07276880","phase":"2","setting":"Preoperative Chemotherapy, Pembrolizumab and Low or High Dose RADiation in an Expansion Cohort of Node(+), Triple Negative Breast Cancer","sponsor":"UNC Lineberger Comprehensive Cancer Center","started":"2026-03-17","startedType":"actual","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04495088","kind":"trial","name":"Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 3 trial of fOLFOX (5-FU, leucovorin, oxaliplatin), cAPOX (capecitabine, oxaliplatin) and capecitabine in colorectal cancer, run by Ralf Hofheinz, now recruiting.","summary":"Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT04495088 by Ralf Hofheinz, with a registry enrolment figure of 550 participants, started 2020-09-30 and due to reach its primary completion in 2030-08. Interventions recorded: mFOLFOX (neoadjuvant); XELOX (neoadjuvant); mFOLFOX (adjuvant); XELOX (adjuvant); Capecitabine (adjuvant); infusional 5-FU/FA \"AIO\" regimen (adjuvant); infusional 5-FU/FA \"de Gramont\" (adjuvant). Conditions listed: Rectal Cancer. Primary outcome: disease-free survival. Colorectal eligibility wording from the registry: \"Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localised 0 - 16 cm from the anocutaneous line as measured by rigid rectoscopy (i\". Sites: Germany. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04495088","url":"https://clinicaltrials.gov/study/NCT04495088"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","capox","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04495088","phase":"3","setting":"Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer and Low Risk for Local Failure: A Randomized Phase III Trial of the German Rectal Cancer Study Group","sponsor":"Ralf Hofheinz","started":"2020-09-30","startedType":"actual","enrolled":550,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04801511","kind":"trial","name":"Preoperative IMRT With Concurrent High-dose Vitamin C and mFOLFOX6 in Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of High-dose intravenous vitamin C in Rectal cancer, run by Zhou Fuxiang, with a status the registry has not verified recently.","summary":"Preoperative IMRT With Concurrent High-dose Vitamin C and mFOLFOX6 in Locally Advanced Rectal Cancer is a phase 2 interventional study registered as NCT04801511 by Zhou Fuxiang, with 60 participants planned, started 2021-03-08 and due to reach its primary completion in 2023-06-30. Interventions recorded: Vitamin C. Conditions recorded: Rectal Cancer.\n\nLinked to the technology High-dose intravenous vitamin C because the registry's title names it (\"high dose intravenous vitamin c\") and Rectal cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04801511","url":"https://clinicaltrials.gov/study/NCT04801511"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["high-dose-vitamin-c"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04801511","phase":"2","setting":"Safety and Efficacy of Preoperative IMRT (Intensity-modulated Radiation Therapy) With Concurrent High-dose Intravenous Vitamin C and mFOLFOX6 in Locally Advanced Rectal Cancer Patients: a Prospective Study.","sponsor":"Zhou Fuxiang","started":"2021-03-08","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05083247","kind":"trial","name":"Preoperative mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma","aka":["STEREOPAC"],"tldr":"A phase 2 trial in pancreatic cancer, run by Erasme University Hospital, now recruiting.","summary":"Preoperative mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma is a phase 2, randomised interventional study registered as NCT05083247 by Erasme University Hospital, with a registry enrolment figure of 256 participants, started 2023-03-24 and due to reach its primary completion in 2027-12-31. Interventions recorded: mFOLFIRINOX or Gemcitabine nab-paclitaxel; Isotoxic High-Dose (iHD)-SBRT; Surgery. Conditions listed: Pancreatic Neoplasm; Pancreatic Adenocarcinoma; Borderline Resectable Pancreatic Adenocarcinoma. Primary outcome: Disease free survival; R0 Resection rate. Pancreatic eligibility wording from the registry: \"* Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinated process or body or tail\". Sites: Belgium. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05083247","url":"https://clinicaltrials.gov/study/NCT05083247"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05083247","phase":"2","setting":"Preoperative Treatment With mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for Borderline Resectable Pancreatic Adenocarcinoma: a Randomised Phase II Study (STEREOPAC)","sponsor":"Erasme University Hospital","started":"2023-03-24","startedType":"actual","enrolled":256,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06623656","kind":"trial","name":"Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC","aka":[],"tldr":"A phase 2 trial of cemiplimab in lung cancer, run by Weill Medical College of Cornell University, now recruiting.","summary":"Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC is a phase 2, randomised interventional study registered as NCT06623656 by Weill Medical College of Cornell University, with a registry enrolment figure of 112 participants, started 2025-02-21 and due to reach its primary completion in 2026-12. Interventions recorded: Cemiplimab; Platinum based chemotherapy; Stereotactic body radiation therapy. Conditions listed: Carcinoma, Non-Small-Cell Lung. Primary outcome: Number of participants with pathological complete response (pCR). Lung eligibility wording from the registry: \"Patients with histologically or cytologically proven clinical stages IB (T2aN0), II, and III(N2) NSCLC (according to AJCC version 9) eligible for surgical resection with curative intent\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06623656","url":"https://clinicaltrials.gov/study/NCT06623656"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","sbrt"],"targets":[],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06623656","phase":"2","setting":"Multicenter Randomized Phase II Trial of Neoadjuvant Radioimmunotherapy Versus Chemoimmunotherapy in Patients With Clinical Stages IB-III (N2) Non-small Cell Lung Cancer","sponsor":"Weill Medical College of Cornell University","started":"2025-02-21","startedType":"actual","enrolled":112,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05752136","kind":"trial","name":"Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma","aka":["PRECAM-R"],"tldr":"A phase 3 trial of envafolimab in colorectal cancer, run by Sir Run Run Shaw Hospital, now recruiting.","summary":"Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma is a phase 3, randomised interventional study registered as NCT05752136 by Sir Run Run Shaw Hospital, with a registry enrolment figure of 108 participants, started 2023-04-01 and due to reach its primary completion in 2026-11-01. Interventions recorded: Envafolimab. Conditions listed: Rectal Cancer. Primary outcome: pCR rate. Colorectal eligibility wording from the registry: \"Diagnosed by digital rectal examination, colonoscopy, and high-resolution MRI of the pelvis, the tumor is less than or equal to 12 cm from the anus\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05752136","url":"https://clinicaltrials.gov/study/NCT05752136"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["envafolimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05752136","phase":"3","setting":"Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma: a Prospective, Multicenter, Randomized Controlled Study (PRECAM-R)","sponsor":"Sir Run Run Shaw Hospital","started":"2023-04-01","startedType":"actual","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05679583","kind":"trial","name":"Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Yonsei University, now recruiting.","summary":"Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer is a phase 2, interventional study registered as NCT05679583 by Yonsei University, with a registry enrolment figure of 25 participants, started 2022-09-26 and due to reach its primary completion in 2026-09-25. Interventions recorded: Preoperative Stereotactic body radiation therapy (SBRT), Pancreatic resection, Adjuvant Chemotherapy. Conditions listed: Pancreatic Cancer. Primary outcome: R0 rate. Pancreatic eligibility wording from the registry: \"Histologically diagnosed adenocarcinoma of the pancreas\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05679583","url":"https://clinicaltrials.gov/study/NCT05679583"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05679583","phase":"2","setting":"Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer: A Prospective Phase II Study","sponsor":"Yonsei University","started":"2022-09-26","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07271355","kind":"trial","name":"Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases,","aka":[],"tldr":"A phase 3 trial of bevacizumab (glioblastoma use), fluorouracil (5-FU), irinotecan (and liposomal irinotecan), leucovorin (folinic acid) and other drugs in colorectal cancer, run by City of Hope Medical Center, not yet recruiting.","summary":"Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial is a phase 3, randomised interventional study registered as NCT07271355 by City of Hope Medical Center, with a registry enrolment figure of 129 participants, started 2026-10-01 and due to reach its primary completion in 2031-02-28. Interventions recorded: Bevacizumab; Biopsy Procedure; Biospecimen Collection; Computed Tomography; Fluorouracil; Irinotecan Hydrochloride; Leucovorin Calcium; Magnetic Resonance Imaging; Mitomycin; Questionnaire Administration. Conditions listed: Metastatic Appendix Carcinoma; Metastatic Colorectal Carcinoma; Metastatic Malignant Neoplasm in the Peritoneum; Stage IV Appendix Carcinoma AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Unresectable Colorectal Carcinoma. Primary outcome: Overall survival (OS). Colorectal eligibility wording from the registry: \"* Histologically or cytologically confirmed appendiceal or colorectal cancer peritoneal metastases\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07271355","url":"https://clinicaltrials.gov/study/NCT07271355"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","hipec","topoisomerase-inhibitors"],"targets":[],"drugs":["bevacizumab-glioma","fluorouracil","irinotecan","leucovorin","mitomycin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07271355","phase":"3","setting":"Investigation of Mitomycin C PIPAC - FOLFIRI Combination for Unresectable Appendiceal or Colorectal Peritoneal Metastases Treatment (IMPACT): A Multicenter, Randomized, Open-Label, Phase 3 Trial","sponsor":"City of Hope Medical Center","started":"2026-10-01","startedType":"estimated","enrolled":129,"enrolledBasis":"registry","outcomes":[]},{"id":"prevail","kind":"trial","name":"PREVAIL","aka":["PREVAIL","MDV3100-04"],"tldr":"Moved enzalutamide in front of chemotherapy, cutting the risk of the cancer showing on scans by four fifths and the risk of death by a third.","summary":"PREVAIL randomised 1,717 men with metastatic castration-resistant prostate cancer who had not had chemotherapy to enzalutamide 160 mg daily or placebo. It was stopped at a planned interim analysis after 540 deaths.\n\nRadiographic progression-free survival at 12 months was 65 percent with enzalutamide against 14 percent with placebo, an 81 percent risk reduction, hazard ratio 0.19 (95 percent confidence interval 0.15 to 0.23, p<0.001). At the data cutoff, 626 of the enzalutamide group (72 percent) and 532 of the placebo group (63 percent) were alive, hazard ratio for death 0.71 (0.60 to 0.84, p<0.001).\n\nSecondary endpoints all favoured enzalutamide: time to starting cytotoxic chemotherapy (hazard ratio 0.35), time to first skeletal-related event (0.72), complete or partial soft-tissue response (59 against 5 percent), time to PSA progression (0.17) and a PSA decline of at least 50 percent (78 against 3 percent), all p<0.001. Fatigue and hypertension were the most common clinically relevant adverse events.\n\nIn England NICE TA377 recommends enzalutamide within its marketing authorisation for metastatic hormone-relapsed prostate cancer in men with no or mild symptoms after androgen deprivation has failed and before chemotherapy is indicated, with the patient access scheme discount.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01212991","url":"https://clinicaltrials.gov/study/NCT01212991"},{"label":"PREVAIL (New England Journal of Medicine 2014)","url":"https://doi.org/10.1056/NEJMoa1405095"},{"label":"NICE TA377: enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated","url":"https://www.nice.org.uk/guidance/ta377"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":["androgen-receptor"],"drugs":["enzalutamide"],"companies":["astellas","pfizer"],"institutions":[],"pathways":[],"terms":["arpi","castration-resistance","psa50"],"trials":["affirm","cou-aa-302"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01212991","phase":"3","setting":"Metastatic castration-resistant prostate cancer progressing despite androgen deprivation and not yet treated with chemotherapy: enzalutamide 160 mg daily against placebo, with co-primary endpoints of radiographic progression-free survival and overall survival","sponsor":"Medivation and Astellas","result":"Radiographic progression-free survival at 12 months 65 against 14 percent (hazard ratio 0.19, 95 percent confidence interval 0.15 to 0.23) and hazard ratio for death 0.71 (0.60 to 0.84) before chemotherapy.","started":"2010-09-16","startedType":"actual","yearReported":2014,"enrolled":1717,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic progression-free survival at 12 months","primary":true,"unit":"%","arms":[{"name":"Enzalutamide 160 mg daily","value":65},{"name":"Placebo","value":14}],"hr":0.19,"ci":[0.15,0.23],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1405095"},{"endpoint":"Overall survival","primary":true,"arms":[{"name":"Enzalutamide 160 mg daily","note":"72 percent alive at data cutoff"},{"name":"Placebo","note":"63 percent alive at data cutoff"}],"hr":0.71,"ci":[0.6,0.84],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1405095"},{"endpoint":"PSA decline of 50 percent or more","unit":"%","arms":[{"name":"Enzalutamide 160 mg daily","value":78},{"name":"Placebo","value":3}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1405095"}],"replication":"COU-AA-302 found the same for abiraterone before chemotherapy in 1,088 men."},{"id":"nct06220032","kind":"trial","name":"Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma","aka":["ANTICIPATE"],"tldr":"A phase 3 trial of Dexrazoxane, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Lenalidomide and Pegfilgrastim in Diffuse large B-cell lymphoma, run by Stichting Hemato-Oncologie voor Volwassenen Nederland, now recruiting.","summary":"Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma is a phase 3 interventional study registered as NCT06220032 by Stichting Hemato-Oncologie voor Volwassenen Nederland, with 324 participants planned, started 2024-08-15 and due to reach its primary completion in 2028-12-15. Interventions recorded: Dexrazoxane, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, Lenalidomide, Pegfilgrastim. Conditions recorded: DLBCL - Diffuse Large B Cell Lymphoma.\n\nLinked to the drug Dexrazoxane because the registry names it among its interventions and Diffuse large B-cell lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06220032","url":"https://clinicaltrials.gov/study/NCT06220032"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["dexrazoxane","rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone","lenalidomide","pegfilgrastim"],"companies":["hovon"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06220032","phase":"3","setting":"ANTICIPATE: Prevention of ANThracycline-Induced Cardiac Dysfunction by Dexrazoxane In PATients With diffusE Large B-cell Lymphoma: a Phase III National Multicenter Prospective Randomized Open-label Trial","sponsor":"Stichting Hemato-Oncologie voor Volwassenen Nederland","started":"2024-08-15","startedType":"actual","enrolled":324,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03172299","kind":"trial","name":"Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-VEGF in Patients Treated with Proton Therapy for a Large Choroidal Melanoma","aka":[],"tldr":"A phase 3 trial of Ziv-aflibercept in Uveal melanoma, run by Centre Hospitalier Universitaire de Nice, completed.","summary":"Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-VEGF in Patients Treated with Proton Therapy for a Large Choroidal Melanoma is a phase 3 interventional study registered as NCT03172299 by Centre Hospitalier Universitaire de Nice, with 57 participants recorded, started 2017-06-08 and reaching its primary completion in 2025-01-31. Interventions recorded: Aflibercept Injection, False injection. Conditions recorded: Ocular Melanoma.\n\nLinked to the drug Ziv-aflibercept because the registry names it among its interventions and Uveal melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03172299","url":"https://clinicaltrials.gov/study/NCT03172299"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["uveal-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["ziv-aflibercept"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03172299","phase":"3","setting":"Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-Vascular Endothelial Growth Factor in Patients Treated with Proton Therapy for a Large Choroidal Melanoma","sponsor":"Centre Hospitalier Universitaire de Nice","started":"2017-06-08","startedType":"actual","enrolled":57,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00515762","kind":"trial","name":"Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling","aka":["ELASTO-GEL CAPS"],"tldr":"A phase 2 trial of Scalp cooling in Breast cancer, run by Hospital San Carlos, Madrid, completed.","summary":"Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling is a phase 2 interventional study registered as NCT00515762 by Hospital San Carlos, Madrid, with 150 participants recorded, started 2007-05 and reaching its primary completion in 2010-06. Interventions recorded: elasto-gel cap. Conditions recorded: Alopecia, Breast Cancer.\n\nLinked to the technology Scalp cooling because the registry's title names it (\"scalp cooling\") and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00515762","url":"https://clinicaltrials.gov/study/NCT00515762"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["scalp-cooling"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00515762","phase":"2","setting":"Pilot Trial of Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling (ELASTO-GEL CAPS)in Breast Cancer Patients","sponsor":"Hospital San Carlos, Madrid","started":"2007-05","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06616987","kind":"trial","name":"Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of sacituzumab govitecan and pegfilgrastim in triple-negative breast cancer, run by Yeon Hee Park, now recruiting.","summary":"Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer is a phase 2, interventional study registered as NCT06616987 by Yeon Hee Park, with a registry enrolment figure of 40 participants, started 2025-07-03 and due to reach its primary completion in 2027-06-30. Interventions recorded: Sacituzumab Govitecan with pegfilgrastim. Conditions listed: Breast Cancer Metastatic. Triple-negative eligibility wording from the registry: \"Histologically confirmed TNBC per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria based on local testing on the most recent analyzed biopsy\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06616987","url":"https://clinicaltrials.gov/study/NCT06616987"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-govitecan","pegfilgrastim"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06616987","phase":"2","setting":"A Multicenter, Open-label, Single-arm, Clinical Trial to Evaluate the Preventive Effect of Pegylated G-CSF (PG) on Neutropenia in Patients With Metastatic Triple-negative Breast Cancer (mTNBC) Receiving Sacituzumab Govitecan (SG)","sponsor":"Yeon Hee Park","started":"2025-07-03","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07302126","kind":"trial","name":"Preventive Efficacy of Bergmann Enema for Acute Radiation-induced Rectal Injury in Rectal Cancer Patients Undergoing Short-course Radiotherapy","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, not yet recruiting.","summary":"Preventive Efficacy of Bergmann Enema for Acute Radiation-induced Rectal Injury in Rectal Cancer Patients Undergoing Short-course Radiotherapy is a phase 2, interventional study registered as NCT07302126 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 40 participants, started 2025-12-11 and due to reach its primary completion in 2026-09-11. Interventions recorded: Bergmann enema. Conditions listed: Acute Radiation Enteritis. Primary outcome: Incidence of grade 2 or higher radiation-induced rectal injury. Colorectal eligibility wording from the registry: \"Patients with pathologically confirmed mid-lower rectal cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07302126","url":"https://clinicaltrials.gov/study/NCT07302126"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07302126","phase":"2","setting":"Preventive Efficacy of Bergmann Enema for Acute Radiation-induced Rectal Injury in Rectal Cancer Patients Undergoing Short-course Radiotherapy: a Prospective, Single-arm, Phase II Trial","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2025-12-11","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06157151","kind":"trial","name":"PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer","aka":[],"tldr":"A phase 2 trial of Pembrolizumab in cervical cancer, run by Precigen, Inc, now recruiting.","summary":"PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer is a phase 2 interventional study registered as NCT06157151 by Precigen, Inc, with 24 participants planned, started 2025-11-11 and due to reach its primary completion in 2026-11-11. Interventions recorded: PRGN-2009 plus Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06157151","url":"https://clinicaltrials.gov/study/NCT06157151"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["precigen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06157151","phase":"2","setting":"A Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer.","sponsor":"Precigen, Inc","started":"2025-11-11","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"prima-follicular","kind":"trial","name":"PRIMA","aka":["Primary Rituximab and Maintenance","PRIMA trial","Rituximab maintenance in follicular lymphoma"],"tldr":"Two years of an antibody given every two months after chemotherapy more than doubled the time before follicular lymphoma came back, but after nine years the two groups were equally likely to be alive.","summary":"PRIMA is the trial that made rituximab maintenance a routine offer in follicular lymphoma, and the trial that shows most clearly why a progression-free survival benefit is not the same as a survival benefit. It ran at 223 centres in 25 countries. Patients with previously untreated high tumour burden follicular lymphoma received one of three immunochemotherapy induction regimens in routine use; the 1,018 who reached a complete or partial response were randomised to rituximab 375 mg per square metre every eight weeks for two years, or to observation.\n\nThe first report, at a median follow-up of 36 months, gave three-year progression-free survival of 74.9 per cent with maintenance against 57.6 per cent with observation (hazard ratio 0.55, 95 per cent confidence interval 0.44 to 0.68). The final report, after nine years, kept the effect: median progression-free survival 10.5 years against 4.1 years (hazard ratio 0.61, 0.52 to 0.73). Ten-year overall survival was approximately 80 per cent in both arms, with a p value of 0.7948, and no new safety signals.\n\nSix extra years before the next treatment is a large thing in a disease people live with for decades, and it is the right thing to put in front of someone deciding. So is the fact that it did not change how long they lived, and that two further years of an antibody carries infection risk and clinic visits. Both numbers belong in the conversation.","status":"mixed","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT00140582","url":"https://clinicaltrials.gov/study/NCT00140582"},{"label":"Lancet 2011","url":"https://doi.org/10.1016/S0140-6736(10)62175-7"},{"label":"Journal of Clinical Oncology 2019","url":"https://doi.org/10.1200/JCO.19.01073"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["follicular-lymphoma","non-hodgkin-lymphoma"],"sections":["immunotherapy"],"technologies":["monoclonal-antibody"],"targets":["cd20"],"drugs":["rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":["lysa"],"institutions":[],"pathways":[],"terms":["maintenance-therapy","lymphoma-tx-maintenance","flipi","watchful-waiting"],"trials":[],"people":["gilles-salles"],"bottlenecks":["b-toxicity-qol","b-patient-voice"],"keyPapers":["paper-prima-rituximab-maintenance-follicular-lancet-2011","paper-prima-final-rituximab-maintenance-follicular-jco-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00140582","phase":"3","setting":"High tumour burden follicular lymphoma responding to first-line immunochemotherapy: two years of rituximab maintenance against observation","sponsor":"Lymphoma Study Association","result":"Median progression-free survival 10.5 against 4.1 years (hazard ratio 0.61) with no difference in ten-year overall survival, which was about 80 per cent in both arms.","started":"2004-12","startedType":"actual","yearReported":2019,"enrolled":1018,"enrolledBasis":"randomised","enrolledNote":"1,217 patients received induction; 1,018 completed it and were randomised between maintenance and observation.","outcomes":[{"endpoint":"Progression-free survival (median)","primary":true,"unit":"years","arms":[{"name":"Rituximab maintenance","n":505,"value":10.5},{"name":"Observation","n":513,"value":4.1}],"hr":0.61,"ci":[0.52,0.73],"source":"https://doi.org/10.1200/JCO.19.01073"},{"endpoint":"Overall survival at 10 years","unit":"%","arms":[{"name":"Rituximab maintenance","value":80},{"name":"Observation","value":80}],"p":"0.7948"}],"replication":"Consistent with the earlier ECOG and EORTC maintenance trials in relapsed disease; the absence of a survival benefit has been reproduced in every one of them."},{"id":"prima","kind":"trial","name":"PRIMA / ENGOT-OV26","aka":[],"tldr":"Extended PARP maintenance to women without BRCA mutations, but the survival benefit did not materialise on longer follow-up.","summary":"PFS 13.8 vs 8.2 months overall (HR 0.62) and 21.9 vs 10.4 months in HRD-positive disease (HR 0.43; NEJM 2019), leading to an all-comers first-line maintenance approval in 2020. The final overall survival analysis (2024) showed no OS difference (HR 1.01 overall), and the HR-proficient subgroup's benefit was small, prompting label debates and a shift toward HRD-guided use.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02655016","url":"https://clinicaltrials.gov/study/NCT02655016"},{"label":"NEJM 2019","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1910962"}],"tags":[],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":["parp"],"drugs":["niraparib"],"companies":["lysa"],"institutions":[],"pathways":[],"terms":["hrd"],"trials":[],"people":["antonio-gonzalez-martin"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02655016","phase":"3","setting":"Newly diagnosed advanced ovarian cancer at high risk of relapse, any BRCA/HRD status: niraparib maintenance vs placebo","sponsor":"GSK (Tesaro)","result":"PFS HR 0.62 overall, 0.43 HRD-positive; final OS HR 1.01.","started":"2016-07-11","startedType":"actual","yearReported":2019,"enrolled":733,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (HRD-positive)","primary":true,"unit":"months","arms":[{"name":"Niraparib","value":21.9},{"name":"Placebo","value":10.4}],"hr":0.43,"ci":[0.31,0.59],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1910962"},{"endpoint":"Progression-free survival (overall)","primary":true,"unit":"months","arms":[{"name":"Niraparib","n":487,"value":13.8},{"name":"Placebo","n":246,"value":8.2}],"hr":0.62,"ci":[0.5,0.76],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1910962"}],"replication":"ATHENA-MONO (rucaparib) reproduced the all-comers PFS gain; no all-comers OS benefit has been shown for any PARP inhibitor."},{"id":"prima-cns","kind":"trial","name":"PRIMA-CNS","aka":["PRIMA-CNS trial","R-MP versus MARTA with transplant in elderly primary CNS lymphoma"],"tldr":"The first randomised trial asking whether older people with lymphoma of the brain do better with a short intensive course and a stem cell transplant than with the gentler long regimen that is standard in Germany.","summary":"Most people diagnosed with primary central nervous system lymphoma are 60 or older, and the two strategies used for them have never been compared head to head. The conventional approach, R-MP, gives rituximab with high-dose methotrexate and procarbazine, followed by procarbazine maintenance. The alternative, MARTA, gives a shorter induction of rituximab, high-dose methotrexate and cytarabine, followed by age-adjusted high-dose chemotherapy and autologous stem-cell transplantation; single-arm work has shown it feasible in selected elderly patients.\n\nPRIMA-CNS randomises 340 patients between them at German sites, with progression-free survival as the primary endpoint and primary completion estimated for 31 August 2029. The IELSG32 and MATRix/IELSG43 trials answered the consolidation question in younger patients; this is the same question for the age group that makes up most of the disease.\n\nThe trial's secondary endpoints matter more than usual here, because the treatments differ in neurotoxicity as well as in intensity, and cognitive outcome is the thing survivors of this disease live with.","status":"active","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT06830421","url":"https://clinicaltrials.gov/study/NCT06830421"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["primary-cns-lymphoma","non-hodgkin-lymphoma"],"sections":["chemotherapy","cell-therapy"],"technologies":["cytotoxic-chemotherapy"],"targets":["cd20"],"drugs":["rituximab","methotrexate","procarbazine","cytarabine"],"companies":["ielsg"],"institutions":[],"pathways":[],"terms":["autologous-transplant","lymphoma-tx-transplant-role"],"trials":["ielsg32","ielsg43"],"people":[],"bottlenecks":["b-brain-delivery","b-aging-comorbidity","b-rare-cancers"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06830421","phase":"3","setting":"Elderly patients with newly diagnosed primary central nervous system lymphoma: rituximab with high-dose methotrexate and procarbazine followed by procarbazine maintenance, against a short rituximab, methotrexate and cytarabine induction followed by age-adjusted high-dose chemotherapy with autologous stem-cell transplantation","sponsor":"University Hospital Freiburg","started":"2023-08-09","startedType":"actual","enrolled":340,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07135882","kind":"trial","name":"Primary Radiotherapy In MEtastatic Lung Cancer","aka":["PRIME-Lung"],"tldr":"A phase 3 trial in lung cancer, run by Trans Tasman Radiation Oncology Group, not yet recruiting.","summary":"Primary Radiotherapy In MEtastatic Lung Cancer is a phase 3, randomised interventional study registered as NCT07135882 by Trans Tasman Radiation Oncology Group, with a registry enrolment figure of 420 participants, started 2026-08-25 and due to reach its primary completion in 2030-12-31. Interventions recorded: Radiotherapy followed by chemotherapy; Standard of Care (SOC). Conditions listed: Carcinoma, Non-Small-Cell Lung (NSCLC). Primary outcome: Overall survival. Lung eligibility wording from the registry: \"* Newly diagnosed metastatic (stage IV) NSCLC, not amenable to curative surgery or curative radiotherapy\". Sites: Australia. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07135882","url":"https://clinicaltrials.gov/study/NCT07135882"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["trog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07135882","phase":"3","setting":"A Randomised Phase III Trial of Up-front Radiotherapy With Standard-of-care Systemic Therapy in Advanced Lung Cancer","sponsor":"Trans Tasman Radiation Oncology Group","started":"2026-08-25","startedType":"estimated","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"prime","kind":"trial","name":"PRIME","aka":["Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy"],"tldr":"The trial that widened the RAS test from two spots in one gene to all of KRAS and NRAS, because patients with any RAS mutation were harmed by the antibody.","summary":"PRIME randomised 1,183 patients with previously untreated metastatic colorectal cancer to FOLFOX4 with or without panitumumab. The prospective-retrospective RAS analysis tested KRAS exons 3 and 4 and NRAS exons 2, 3 and 4 in patients without KRAS exon 2 mutations, with 90 percent ascertainment. Among 512 patients without any RAS mutation, progression-free survival was 10.1 against 7.9 months (hazard ratio 0.72, 95% CI 0.58 to 0.90, p=0.004) and overall survival 26.0 against 20.2 months (hazard ratio 0.78, 0.62 to 0.99, p=0.04). A further 108 patients, 17 percent of those with wild-type KRAS exon 2, carried other RAS mutations, and in them panitumumab shortened progression-free and overall survival. BRAF mutation was prognostic, not predictive. PRIME is why extended RAS testing, not KRAS exon 2 alone, is mandatory before any EGFR antibody.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00364013","url":"https://clinicaltrials.gov/study/NCT00364013"},{"label":"PRIME: panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer (New England Journal of Medicine 2013)","url":"https://doi.org/10.1056/NEJMoa1305275"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["monoclonal-antibody","cytotoxic-chemotherapy"],"targets":["egfr","kras","nras","braf"],"drugs":["panitumumab","folfox","oxaliplatin","fluorouracil"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":["sidedness"],"trials":["crystal-fire3","paradigm","opus"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00364013","phase":"3","setting":"Previously untreated metastatic colorectal cancer: FOLFOX4 with or without panitumumab, analysed by extended RAS status","sponsor":"Amgen","result":"In RAS wild-type disease, overall survival 26.0 against 20.2 months (hazard ratio 0.78); patients with non-exon-2 RAS mutations did worse with panitumumab.","started":"2006-08-01","startedType":"actual","yearReported":2013,"enrolled":1183,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (RAS wild-type)","primary":true,"unit":"months","arms":[{"name":"FOLFOX4 plus panitumumab","value":26},{"name":"FOLFOX4","value":20.2}],"hr":0.78,"ci":[0.62,0.99],"p":"0.04","source":"https://doi.org/10.1056/NEJMoa1305275"},{"endpoint":"Progression-free survival (RAS wild-type)","unit":"months","arms":[{"name":"FOLFOX4 plus panitumumab","value":10.1},{"name":"FOLFOX4","value":7.9}],"hr":0.72,"ci":[0.58,0.9],"p":"0.004","source":"https://doi.org/10.1056/NEJMoa1305275"}],"replication":"The same extended-RAS effect was found retrospectively in CRYSTAL, OPUS and FIRE-3 and prospectively in PARADIGM."},{"id":"prime-ii","kind":"trial","name":"PRIME II","aka":[],"tldr":"PRIME II confirmed in a larger and more recent population that omitting radiotherapy in older women with low-risk hormone-sensitive breast cancer raises local recurrence modestly without affecting survival.","summary":"PRIME II randomised 1,326 women aged 65 or older with hormone receptor-positive, node-negative breast cancers up to 3 cm, treated by breast-conserving surgery and endocrine therapy, to radiotherapy or none. Ten-year local recurrence was 9.5 percent without radiotherapy and 0.9 percent with it; distant recurrence, breast cancer-specific and overall survival did not differ (Kunkler and colleagues, Lancet Oncology 2015 and New England Journal of Medicine 2023).","status":"positive","asOf":"2026-09-16","links":[{"label":"ISRCTN95889329","url":"https://www.isrctn.com/ISRCTN95889329"},{"label":"NEJM 2023","url":"https://doi.org/10.1056/NEJMoa2207586"}],"tags":["radiation-wave2"],"related":[],"cancers":["breast-hr-positive","breast-cancer"],"sections":[],"technologies":["imrt-igrt","active-surveillance"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["radiotherapy-omission-early-breast-cancer"],"trials":["calgb-9343","lumina"],"people":[],"bottlenecks":[],"keyPapers":["paper-kunkler-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Women aged 65 or over with low-risk hormone receptor-positive breast cancer after breast-conserving surgery: endocrine therapy with or without whole-breast radiotherapy","sponsor":"University of Edinburgh","result":"10-year local recurrence 9.5% (no radiotherapy) vs 0.9% (radiotherapy); no difference in survival.","yearReported":2015,"enrolled":1326,"enrolledBasis":"registry","outcomes":[{"endpoint":"Ipsilateral breast tumour recurrence at 10 years","primary":true,"unit":"%","arms":[{"name":"Endocrine therapy alone","n":668,"value":9.5},{"name":"Endocrine therapy plus radiotherapy","n":658,"value":0.9}]}]},{"id":"primus-001","kind":"trial","name":"PRIMUS 001","aka":["PRIMUS-001","PRIMUS001","Precision-Panc PRIMUS 001"],"tldr":"PRIMUS 001 is the flagship trial of the UK Precision-Panc programme, comparing a new oxaliplatin, fluorouracil and nab-paclitaxel combination with standard nab-paclitaxel and gemcitabine at 30 NHS hospitals from Aberdeen to Plymouth while collecting tumour DNA to find who benefits from which chemotherapy.","summary":"PRIMUS 001 (ISRCTN75002153, NCT04151277) opened in November 2017 and randomises patients with metastatic pancreatic cancer to FOLFOX-A or nab-paclitaxel plus gemcitabine with G-CSF support, with progression-free survival as the primary endpoint and a biomarker programme run through Precision-Panc's molecular profiling. The registry lists 500 participants (estimated), 30 UK sites (Aberdeen, Belfast, Birmingham, Bournemouth, Bristol, Cambridge, Cottingham, Dundee, Edinburgh, Glasgow, Huddersfield, Inverness, Leeds, Liverpool, Guy's and Imperial in London among them), a primary completion date of December 2025 and a status of unknown because the record has not been verified since; no results were found in Europe PMC on 24 September 2026. Its siblings PRIMUS 002 (neoadjuvant chemotherapy for resectable disease) and PRIMUS 004 (biomarker-directed second-line platform) are registered with ISRCTN.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04151277","url":"https://clinicaltrials.gov/study/NCT04151277"},{"label":"ISRCTN75002153: PRIMUS 001","url":"https://www.isrctn.com/ISRCTN75002153"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","cgp"],"targets":[],"drugs":["folfox","nab-paclitaxel","gemcitabine-nab-paclitaxel"],"companies":[],"institutions":["cruk"],"pathways":[],"terms":["pancreatic-trials-open-today"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 30): Aberdeen Royal Infirmary; Northern Ireland Cancer Centre Belfast; Queen Elizabeth Hospital Birmingham; Royal Bournemouth; Bristol Oncology Centre; Addenbrooke's Cambridge; Castle Hill Cottingham; Ninewells Dundee; Western General Edinburgh; Beatson Glasgow; Huddersfield Royal Infirmary; Raigmore Inverness; St James's Leeds; Clatterbridge Liverpool; Guy's and Imperial College London, and others."],"nct":"NCT04151277","phase":"2","setting":"Metastatic pancreatic cancer at 30 UK hospitals: FOLFOX with nab-paclitaxel (FOLFOX-A) against nab-paclitaxel with gemcitabine, an adaptive randomised phase 2 with integrated biomarker evaluation and progression-free survival as the primary endpoint","sponsor":"NHS Greater Glasgow and Clyde and the University of Glasgow (Precision-Panc)","started":"2017-11-28","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"prism-mel-301","kind":"trial","name":"PRISM-MEL-301","aka":[],"tldr":"Tests whether a PRAME-directed T-cell engager adds to first-line immunotherapy in ordinary skin melanoma, following tebentafusp's success in the eye form.","summary":"PRISM-MEL-301, trial NCT06112314 sponsored by Immunocore, tests whether the PRAME-directed T-cell engager brenetafusp adds to first-line nivolumab-based immunotherapy in untreated HLA-A*02:01-positive advanced cutaneous melanoma, following tebentafusp's success in the eye form of the disease. The phase 3 launched in 2024, and supporting phase 1/2 data at ASCO 2026 in 66 heavily pretreated patients on monotherapy showed encouraging survival, with the 160 microgram dose carried into phase 3; PRAME is expressed in most cutaneous melanomas, giving a broader target than gp100. OnCo links it to T-cell engagers, PRAME and CD3 as targets, brenetafusp, nivolumab and Immunocore. It is recruiting with no results, and whether a soluble TCR bispecific can improve first-line outcomes in a common solid tumour is the question it exists to answer.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06112314","url":"https://clinicaltrials.gov/study/NCT06112314"},{"label":"Immunocore ASCO 2026 update","url":"https://www.globenewswire.com/news-release/2026/05/31/3303917/0/en/immunocore-presents-updated-phase-1-data-of-brenetafusp-in-patients-with-heavily-pretreated-advanced-melanoma.html"}],"tags":[],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["t-cell-engager"],"targets":["prame","cd3"],"drugs":["brenetafusp","nivolumab"],"companies":["immunocore"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06112314","phase":"3","setting":"Untreated HLA-A*02:01-positive advanced cutaneous melanoma: brenetafusp + nivolumab vs nivolumab-based regimens","sponsor":"Immunocore","started":"2024-06-05","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"nct07510828","kind":"trial","name":"PRISM-NK: Precision-Matched Allogeneic Single- or Dual-Target CAR-NK Cells for Advanced Solid Tumors","aka":["PRISM-NK"],"tldr":"A phase 1/2 trial of EB-PT-CAR-NK-S in advanced solid tumours, run by Beijing Biotech, now recruiting.","summary":"PRISM-NK: Precision-Matched Allogeneic Single- or Dual-Target CAR-NK Cells for Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07510828 by Beijing Biotech, with 60 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-03-14. Interventions recorded: EB-PT-CAR-NK-S, EB-PT-CAR-NK-D, Lymphodepleting chemotherapy and Cytokine support.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07510828","url":"https://clinicaltrials.gov/study/NCT07510828"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["liquid-biopsy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07510828","phase":"1/2","setting":"A Phase 1/2 Biomarker-Guided Platform Study of Allogeneic Donor-Derived Single-Target or Dual-Target CAR-NK Cell Therapy Selected by Tumor Antigen Profiling (Liquid Biopsy and/or Tissue Biopsy) in Participants With Advanced Solid Tumors","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07541001","kind":"trial","name":"PRL3-Zumab in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 2 trial of PRL3-ZUMAB in advanced solid tumours, run by Intra-IMMUSG Pte Ltd, active and no longer recruiting.","summary":"PRL3-Zumab in Patients With Advanced Solid Tumors is a phase 2 interventional study registered as NCT07541001 by Intra-IMMUSG Pte Ltd, with 60 participants enrolled, started 2021-08-30 and due to reach its primary completion in 2026-06-01. Interventions recorded: PRL3-ZUMAB.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07541001","url":"https://clinicaltrials.gov/study/NCT07541001"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["intra-immusg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07541001","phase":"2","setting":"An Open Label, Multicenter, Safety and Efficacy Phase II Study of PRL3-Zumab in Solid Tumors","sponsor":"Intra-IMMUSG Pte Ltd","started":"2021-08-30","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06460298","kind":"trial","name":"ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of ProAgio Dose Levels (DL) 1,2,3,4 in triple-negative breast cancer, run by ProDa BioTech, LLC, now recruiting.","summary":"ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer is a phase 1/2 interventional study registered as NCT06460298 by ProDa BioTech, LLC, with 51 participants planned, started 2024-08-20 and due to reach its primary completion in 2027-07-01. Interventions recorded: ProAgio Dose Levels (DL) 1,2,3,4 and ProAgio Dose Expansion.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06460298","url":"https://clinicaltrials.gov/study/NCT06460298"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06460298","phase":"1/2","setting":"Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an Anti- αvβ3 Integrin Cytotoxin, in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer","sponsor":"ProDa BioTech, LLC","started":"2024-08-20","startedType":"actual","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07605728","kind":"trial","name":"Probiotics for Abemaciclib-Induced Abdominal Discomfort.","aka":[],"tldr":"A phase 2 trial of an investigational treatment in advanced solid tumours, run by Leeuwenhoek Laboratories Co. Ltd., now recruiting.","summary":"Probiotics for Abemaciclib-Induced Abdominal Discomfort. is a phase 2 interventional study registered as NCT07605728 by Leeuwenhoek Laboratories Co. Ltd., with 80 participants planned, started 2026-05-15 and due to reach its primary completion in 2029-06-30.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07605728","url":"https://clinicaltrials.gov/study/NCT07605728"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["abemaciclib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07605728","phase":"2","setting":"A Randomized, Phase II Study About Probiotics to Alleviate Abemaciclib-induced Abdominal Discomfort Under Standard Anti-diarrhea Drug Loperamide and Changes of Metabolic Factors in Blood.","sponsor":"Leeuwenhoek Laboratories Co. Ltd.","started":"2026-05-15","startedType":"estimated","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"prodige-23","kind":"trial","name":"PRODIGE 23","aka":[],"tldr":"PRODIGE 23 showed that six cycles of intensive chemotherapy before chemoradiation improves disease-free survival in rectal cancer and, on longer follow-up, overall survival, the second pillar of total neoadjuvant therapy.","summary":"PRODIGE 23 randomised 461 patients with cT3 or cT4 rectal cancer to standard capecitabine chemoradiation followed by surgery and six months of adjuvant chemotherapy, or to six cycles of induction mFOLFIRINOX before the same sequence. Three-year disease-free survival was 76 percent with induction chemotherapy versus 69 percent (hazard ratio 0.69), pathological complete response rose from 12 to 28 percent (Conroy and colleagues, Lancet Oncology 2021), and seven-year results showed an overall survival gain.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01804790","url":"https://clinicaltrials.gov/study/NCT01804790"},{"label":"Lancet Oncology 2021","url":"https://doi.org/10.1016/S1470-2045(21)00079-6"}],"tags":["radiation-wave4"],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["oxaliplatin","irinotecan","fluorouracil","capecitabine"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":["chemoradiation"],"trials":["stellar-rectal","cao-aro-aio-12","iwwd"],"people":[],"bottlenecks":[],"keyPapers":["paper-conroy-prodige-23-neoadjuvant-folfirinox-rectal-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01804790","phase":"3","setting":"Locally advanced rectal cancer: induction mFOLFIRINOX then chemoradiation, surgery and adjuvant chemotherapy, versus chemoradiation, surgery and adjuvant chemotherapy","sponsor":"UNICANCER","result":"3-year disease-free survival 76% vs 69% (hazard ratio 0.69); pathological complete response 28% vs 12%.","started":"2012-01","startedType":"actual","yearReported":2021,"enrolled":461,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Induction mFOLFIRINOX then chemoradiation","n":231,"value":76},{"name":"Chemoradiation first","n":230,"value":69}]}]},{"id":"prodige-24","kind":"trial","name":"PRODIGE 24 / CCTG PA6","aka":[],"tldr":"Showed that giving the strong four-drug chemotherapy after pancreatic surgery adds years of life for fit patients.","summary":"PRODIGE 24, run with the Canadian Cancer Trials Group as CCTG PA6, trial NCT01526135 and reported in 2018, showed that giving modified FOLFIRINOX after pancreatic cancer surgery adds years of life for fit patients compared with gemcitabine. It randomised 493 patients and met its primary disease-free survival endpoint, and the overall survival benefit held in a five-year update in 2022, establishing modified FOLFIRINOX as the adjuvant standard for patients fit enough to receive it. OnCo links it to pancreatic ductal adenocarcinoma, to the FOLFIRINOX drug record and to Thierry Conroy, and the result is consistent with APACT for gemcitabine and nab-paclitaxel, which showed a smaller effect, and with the neoadjuvant PREOPANC-2 comparison. Whether the same regimen should be given before surgery rather than after is the open question. FOLFIRINOX has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT01526135","url":"https://clinicaltrials.gov/study/NCT01526135"},{"label":"Conroy et al., five-year outcomes of PRODIGE 24/CCTG PA6 (JAMA Oncology 2022)","url":"https://doi.org/10.1001/jamaoncol.2022.3829"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfirinox"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":["espac-4","apact","jaspac-01","alliance-a021806","preopanc-3"],"people":["thierry-conroy"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Five-year outcomes (JAMA Oncology 2022, median follow-up 69.7 months, 77 hospitals in France and Canada): median disease-free survival 21.4 against 12.8 months (hazard ratio 0.66; p below 0.001), five-year disease-free survival 26.1 against 19.0 percent; median overall survival 53.5 against 35.5 months (hazard ratio 0.68, 0.54 to 0.85; p 0.001), five-year overall survival 43.2 against 31.4 percent; metastasis-free survival 29.4 against 17.7 months; cancer-specific survival 54.7 against 36.3 months. Grade 3 or 4 adverse events 75.9 against 52.9 percent in the primary report. Eligibility was restricted to fit patients aged 18 to 79 with recovery within 12 weeks of surgery; ESPAC4's long-term analysis found that 26.4 percent of its patients would not have been eligible and that gemcitabine plus capecitabine still helped them (20.7 against 25.9 months). No UK sites."],"nct":"NCT01526135","phase":"3","setting":"Adjuvant therapy after resection of PDAC: mFOLFIRINOX vs gemcitabine","sponsor":"UNICANCER / CCTG","result":"OS 54.4 vs 35.0 months, HR 0.64.","started":"2012-04-16","startedType":"actual","yearReported":2018,"enrolled":493,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival","primary":true,"unit":"months","arms":[{"name":"Adjuvant mFOLFIRINOX","n":247,"value":21.6},{"name":"Adjuvant gemcitabine","n":246,"value":12.8}],"hr":0.58,"ci":[0.46,0.73],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1809775"},{"endpoint":"Overall survival (5-year update)","unit":"months","arms":[{"name":"Adjuvant mFOLFIRINOX","value":53.5},{"name":"Adjuvant gemcitabine","value":35.5}],"hr":0.68,"source":"https://jamanetwork.com/journals/jamaoncology/fullarticle/2795896"}],"replication":"Consistent with APACT (gemcitabine/nab-paclitaxel, smaller effect) and with the neoadjuvant PREOPANC-2 comparison."},{"id":"prodige-4-accord-11","kind":"trial","name":"PRODIGE 4 / ACCORD 11","aka":["PRODIGE 4","ACCORD 11","PRODIGE4-ACCORD11","FOLFIRINOX versus gemcitabine"],"tldr":"PRODIGE 4 is the 2011 French trial that changed pancreatic cancer treatment for the first time in fourteen years: the four-drug FOLFIRINOX combination kept fit patients alive a median 11.1 months against 6.8 with gemcitabine, at the price of more side effects, and it remains the reference first-line regimen for people well enough to have it.","summary":"PRODIGE 4/ACCORD 11 randomised 342 patients with metastatic pancreatic adenocarcinoma and ECOG 0 or 1 to FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, fluorouracil 400 mg/m2 bolus then 2,400 mg/m2 over 46 hours, every two weeks) or gemcitabine 1,000 mg/m2 weekly for seven of eight weeks then three of four. Median overall survival was 11.1 against 6.8 months (hazard ratio for death 0.57, 95 percent confidence interval 0.45 to 0.73; p below 0.001), median progression-free survival 6.4 against 3.3 months (hazard ratio 0.47) and objective response 31.6 against 9.4 percent. Febrile neutropenia occurred in 5.4 percent on FOLFIRINOX, and at six months 31 percent of FOLFIRINOX patients had a definitive deterioration in quality of life against 66 percent on gemcitabine (hazard ratio 0.47). The trial restricted entry to fit patients under 76 with normal bilirubin, which is why guidelines pair it with gemcitabine plus nab-paclitaxel for everyone else; NICE NG85 recommends FOLFIRINOX for performance status 0 to 1 (recommendation 1.9.4, an off-label use in England). The modified regimen without the bolus became the adjuvant standard in PRODIGE 24, and NAPOLI 3 later showed the liposomal-irinotecan variant NALIRIFOX beats gemcitabine plus nab-paclitaxel.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00112658","url":"https://clinicaltrials.gov/study/NCT00112658"},{"label":"Conroy et al., FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer (NEJM 2011)","url":"https://doi.org/10.1056/NEJMoa1011923"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfirinox","gemcitabine","oxaliplatin","irinotecan","fluorouracil","leucovorin"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":["performance-status","quality-of-life"],"trials":[],"people":["thierry-conroy"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00112658","phase":"3","setting":"Untreated metastatic pancreatic cancer with ECOG performance status 0 or 1 at French centres: FOLFIRINOX every two weeks against weekly gemcitabine, six months recommended in responders, with overall survival as the primary endpoint of the phase 3 part","sponsor":"UNICANCER (FNCLCC and FFCD), France","result":"Median overall survival 11.1 months with FOLFIRINOX against 6.8 months with gemcitabine (hazard ratio 0.57, 95 percent confidence interval 0.45 to 0.73; p below 0.001); progression-free survival 6.4 against 3.3 months; response 31.6 against 9.4 percent.","started":"2004-11","startedType":"actual","yearReported":2011,"enrolled":342,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"FOLFIRINOX","n":171,"value":11.1},{"name":"Gemcitabine","n":171,"value":6.8}],"hr":0.57,"ci":[0.45,0.73],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1011923"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"FOLFIRINOX","value":6.4},{"name":"Gemcitabine","value":3.3}],"hr":0.47,"ci":[0.37,0.59],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1011923"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"FOLFIRINOX","value":31.6},{"name":"Gemcitabine","value":9.4}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1011923"}]},{"id":"prodige-7","kind":"trial","name":"PRODIGE 7","aka":[],"tldr":"Washing the abdomen with heated oxaliplatin after complete tumour removal added nothing to survival and caused more late complications. The surgery, not the wash, is what works.","summary":"PRODIGE 7 randomised 265 patients at 17 French centres who had achieved complete macroscopic resection of colorectal peritoneal metastases to oxaliplatin-based HIPEC (360 mg/m2 closed or 460 mg/m2 open abdomen, with intravenous fluorouracil and folinic acid 20 minutes before) or to no HIPEC. After a median 63.8 months, median overall survival was 41.7 against 41.2 months (hazard ratio 1.00, 95.37% CI 0.63 to 1.58, p=0.99). Grade 3 or worse adverse events at 60 days were more common with HIPEC (26 against 15 percent, p=0.035). Both arms did far better than historical series treated with chemotherapy alone, which is the trial's positive message: complete cytoreductive surgery in selected patients gives a median survival above three years. HIPEC with oxaliplatin does not add to it, and COLOPEC and PROPHYLOCHIP separately showed it does not work as prophylaxis either.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00769405","url":"https://clinicaltrials.gov/study/NCT00769405"},{"label":"PRODIGE 7: cytoreductive surgery plus HIPEC versus cytoreductive surgery alone for colorectal peritoneal metastases (Lancet Oncology 2021)","url":"https://doi.org/10.1016/S1470-2045(20)30599-4"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["hipec","hipec-pipac-devices"],"targets":[],"drugs":["oxaliplatin","fluorouracil","leucovorin"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":["debulking"],"trials":["colopec","prophylochip"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00769405","phase":"3","setting":"Colorectal peritoneal metastases with a Peritoneal Cancer Index of 25 or less, after complete macroscopic cytoreduction: oxaliplatin HIPEC added or not, with systemic chemotherapy in both arms","sponsor":"UNICANCER","result":"Median overall survival 41.7 against 41.2 months (hazard ratio 1.00); more late grade 3 or worse complications with HIPEC.","started":"2008-02","yearReported":2021,"enrolled":265,"enrolledBasis":"randomised","enrolledNote":"The registry lists 264 participants; 265 were included and randomised in the Lancet Oncology report.","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Cytoreductive surgery plus oxaliplatin HIPEC","n":133,"value":41.7},{"name":"Cytoreductive surgery alone","n":132,"value":41.2}],"hr":1,"ci":[0.63,1.58],"p":"0.99","source":"https://doi.org/10.1016/S1470-2045(20)30599-4"}],"replication":"COLOPEC (adjuvant HIPEC) and PROPHYLOCHIP (second-look surgery plus HIPEC) were also negative, so three randomised trials agree."},{"id":"nct06762405","kind":"trial","name":"PRODIGE 90 - (FFCD 2204) Neoadjuvant Dostarlimab with Short Course Radiotherapy in a Watch-and-wait Strategy for Microsatellite Unstable or Mismatch Repair-defi","aka":["PREDIR-NEOREC"],"tldr":"A phase 3 trial of dostarlimab in colorectal cancer, run by Centre Hospitalier Universitaire Dijon, now recruiting.","summary":"PRODIGE 90 - (FFCD 2204) Neoadjuvant Dostarlimab with Short Course Radiotherapy in a Watch-and-wait Strategy for Microsatellite Unstable or Mismatch Repair-deficient Locally Advanced Rectal Cancer Patients is a phase 3, randomised interventional study registered as NCT06762405 by Centre Hospitalier Universitaire Dijon, with a registry enrolment figure of 68 participants, started 2025-02-06 and due to reach its primary completion in 2030-09. Interventions recorded: radiotherapy; Dostarlimab; Biological study on circulating tumor DNA (optional for the patient). Conditions listed: Rectal Adenocarcinoma with Mismatch-repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H). Primary outcome: Treatment strategy failure (TSF) rate.. Colorectal eligibility wording from the registry: \"* Histologically proven rectal adenocarcinoma with Mismatch-repair Deficient (dMMR)/ microsatellite instability-high (MSI-H)\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06762405","url":"https://clinicaltrials.gov/study/NCT06762405"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt","mrd-testing"],"targets":[],"drugs":["dostarlimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06762405","phase":"3","setting":"PRODIGE 90 - (FFCD 2204) - PREDIR-NEOREC Neoadjuvant Dostarlimab with Short Course Radiotherapy in a Watch-and-wait Strategy for Microsatellite Unstable or Mismatch Repair-deficient Locally Advanced Rectal Cancer Patients: a Randomized Phase II Trial Phase II Randomized Study Non-comparative - Multicenter","sponsor":"Centre Hospitalier Universitaire Dijon","started":"2025-02-06","startedType":"actual","enrolled":68,"enrolledBasis":"registry","outcomes":[]},{"id":"rejuv-trial-proffi","kind":"trial","name":"PROFFi: fisetin and exercise to prevent frailty in breast cancer survivors","aka":["PROFFi","NCT06113016"],"tldr":"The first randomised trial to test a senolytic in people who have had cancer. Four arms crossing fisetin against placebo with tailored supervised exercise against a physical activity handout, and the primary endpoint is how far someone can walk in six minutes.","summary":"Fisetin is a flavonol found in strawberries and sold as a supplement, and it is being tested here as a senolytic, a drug meant to clear senescent cells. The frontier record on senolytics in this corpus states the gap this trial addresses: fisetin is in trials but has no completed randomised result in cancer survivors, and the human evidence for senolytics generally is four small trials in other diseases with the one properly randomised trial missing its primary endpoint.\n\nThe design is a two-by-two: fisetin or placebo by mouth on days 1 to 3 of each 14-day cycle for eight cycles, crossed with either individually tailored supervised exercise training (30 to 45 minutes of aerobic and 20 to 30 minutes of resistance work) or a handout on the importance of physical activity. The registry describes it as triple-masked with respect to the study agent, with the outcomes assessor blinded to training status because participants cannot be blinded to exercise. The primary endpoint is change in six-minute walk distance from baseline to day 120.\n\nThe reason this trial matters beyond its drug is the endpoint. It measures something a person would notice rather than a marker, in a population where the marker has been shown to move, which is exactly the design the biological-ageing agenda record argues the field needs. Whether fisetin works is a smaller question than whether a trial of this shape can be run at all.\n\nRegistry dates, read on 2 October 2026: start 23 July 2024 (actual), primary completion 31 October 2028 (estimated), completion 31 October 2031 (estimated). Enrolment of 164 is the registry's estimate, not an achieved figure.","status":"recruiting","asOf":"2026-10-02","links":[{"label":"ClinicalTrials.gov NCT06113016","url":"https://clinicaltrials.gov/study/NCT06113016"}],"tags":["rejuvenation","survivorship","open-problem","biological-ageing","senolytics","exercise"],"related":["rejuv-frontier-senolytics","rejuv-age-senescent-cells-after-treatment","rejuv-age-frailty-and-late-effects","rejuv-agenda-biological-age-as-an-untested-target","idea-rejuv-biological-age-as-a-randomised-endpoint","exercise-prescription-after-cancer","rejuvenation-roadmap"],"cancers":["breast-cancer"],"sections":["rejuvenation","supportive-care"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06113016","phase":"2","setting":"Breast cancer survivors after treatment for anatomic stage I to III breast cancer, United States","sponsor":"Jonsson Comprehensive Cancer Center, with the National Cancer Institute and the Rising Tide Foundation","started":"2024-07-23","startedType":"actual","enrolled":164,"enrolledBasis":"registry","outcomes":[]},{"id":"profile-1001-ros1","kind":"trial","name":"PROFILE 1001 ROS1 expansion cohort","aka":["Crizotinib in ROS1-rearranged NSCLC"],"tldr":"Fifty patients in an expansion cohort defined ROS1 as the second treatable fusion in lung cancer and put crizotinib on the label for it.","summary":"ROS1 rearrangements occur in about 1 to 2 percent of non-small-cell lung cancers, most often in younger never-smokers with adenocarcinoma. Crizotinib inhibits ALK, ROS1 and MET, and the kinase domains of ALK and ROS1 are close enough that the same molecule fits both. Fifty patients with ROS1-positive advanced disease were enrolled in an expansion cohort of the phase 1 crizotinib study and treated at the standard 250 mg twice daily.\n\nThe objective response rate was 72 percent (95 percent confidence interval 58 to 84) with three complete and 33 partial responses; median duration of response was 17.6 months and median progression-free survival 19.2 months, with half the patients still in follow-up for progression at the report. Seven ROS1 fusion partners were identified among 30 tumours tested, five known and two new, and the partner did not predict response. Safety matched the ALK experience.\n\nThe FDA added ROS1-positive metastatic non-small-cell lung cancer to the crizotinib label in 2016 on this cohort. NICE TA1021 (4 December 2024) recommends crizotinib for ROS1-positive advanced disease in England. Crizotinib has since been overtaken by entrectinib and repotrectinib, which cross into the brain and, in repotrectinib's case, cover the ROS1 G2032R solvent-front mutation.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00585195","url":"https://clinicaltrials.gov/study/NCT00585195"},{"label":"Crizotinib in ROS1-rearranged NSCLC (New England Journal of Medicine 2014)","url":"https://doi.org/10.1056/NEJMoa1406766"},{"label":"NICE TA1021: crizotinib for treating ROS1-positive advanced non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1021"}],"tags":[],"related":[],"cancers":["ros1-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["ros1"],"drugs":["crizotinib","entrectinib","repotrectinib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":["gene-fusion","oncogene-addiction","tki-term"],"trials":["nct03093116","nct02568267"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00585195","phase":"1","setting":"Advanced ROS1-rearranged non-small-cell lung cancer: crizotinib 250 mg twice daily in an expansion cohort of the phase 1 study, with objective response as the endpoint","sponsor":"Pfizer","result":"Objective response 72 percent (36 of 50); median duration of response 17.6 months; median progression-free survival 19.2 months.","started":"2006-04-19","startedType":"actual","yearReported":2014,"enrolled":50,"enrolledBasis":"treated","enrolledNote":"50 patients with ROS1-rearranged non-small-cell lung cancer were treated in an expansion cohort of a phase 1 study whose registry enrolment covers all cohorts.","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Crizotinib","n":50,"value":72}],"ci":[58,84],"source":"https://doi.org/10.1056/NEJMoa1406766"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Crizotinib","n":50,"value":19.2}],"source":"https://doi.org/10.1056/NEJMoa1406766"}],"replication":"Entrectinib (integrated ALKA-372-001, STARTRK-1 and STARTRK-2 analysis) and repotrectinib (TRIDENT-1) reproduced and exceeded the activity, with intracranial responses crizotinib does not produce."},{"id":"profile-1014","kind":"trial","name":"PROFILE 1014","aka":[],"tldr":"The trial that made an ALK pill, rather than chemotherapy, the first treatment for ALK-positive lung cancer.","summary":"Crizotinib had been approved in 2011 on single-arm response data and confirmed against second-line chemotherapy in PROFILE 1007, but whether it should come before chemotherapy was unknown. PROFILE 1014 randomised 343 patients with untreated advanced ALK-positive non-squamous disease to crizotinib 250 mg twice daily or to pemetrexed with cisplatin or carboplatin every three weeks for up to six cycles, with crossover to crizotinib permitted at progression.\n\nMedian progression-free survival by independent radiological review was 10.9 months with crizotinib against 7.0 months with chemotherapy (hazard ratio 0.45, 95 percent confidence interval 0.35 to 0.60).\n\nPROFILE 1014 is now historical as a treatment recommendation: ALEX, ALTA-1L and CROWN each beat crizotinib with a later-generation inhibitor, and the brain, where crizotinib penetrates poorly, is where they win. Its importance is as the first demonstration that targeting the fusion beats chemotherapy from the start, the template every later fusion programme followed.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01154140","url":"https://clinicaltrials.gov/study/NCT01154140"},{"label":"PROFILE 1014 (New England Journal of Medicine 2014)","url":"https://doi.org/10.1056/NEJMoa1408440"}],"tags":[],"related":[],"cancers":["alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors","cytotoxic-chemotherapy","platinum"],"targets":["alk"],"drugs":["crizotinib","pemetrexed","cisplatin","carboplatin"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":["gene-fusion","oncogene-addiction","tki-term"],"trials":["alex","alta-1l","crown","alesia"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01154140","phase":"3","setting":"Untreated advanced ALK-positive non-squamous non-small-cell lung cancer: crizotinib 250 mg twice daily versus pemetrexed with cisplatin or carboplatin for up to six cycles, with progression-free survival by independent radiological review as the primary endpoint and crossover allowed","sponsor":"Pfizer","result":"Median progression-free survival 10.9 against 7.0 months (hazard ratio 0.45, 95 percent confidence interval 0.35 to 0.60).","started":"2011-01-13","startedType":"actual","yearReported":2014,"enrolled":343,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (independent radiological review)","primary":true,"unit":"months","arms":[{"name":"Crizotinib","value":10.9},{"name":"Pemetrexed and platinum","value":7}],"hr":0.45,"ci":[0.35,0.6],"source":"https://doi.org/10.1056/NEJMoa1408440"}],"replication":"Superseded rather than replicated: ALEX (alectinib), ALTA-1L (brigatinib), ALESIA (alectinib in Asia) and CROWN (lorlatinib) all used crizotinib as the control and beat it."},{"id":"profit-trial","kind":"trial","name":"PROFIT (Prostate Fractionated Irradiation Trial)","aka":["PROFIT","Prostate Fractionated Irradiation Trial","OCOG-PROFIT"],"tldr":"Confirmed that four weeks of radiotherapy works as well as eight for intermediate-risk prostate cancer, without more long-term side effects.","summary":"PROFIT randomised 1,206 men with intermediate-risk prostate cancer, defined as T1 to T2a with Gleason 6 and PSA 10.1 to 20, or T2b to T2c with Gleason 6 and PSA 20 or less, or T1 to T2 with Gleason 7 and PSA 20 or less, to conventional radiotherapy of 78 Gy in 39 fractions over 8 weeks or hypofractionated radiotherapy of 60 Gy in 20 fractions over 4 weeks. Androgen deprivation was not permitted, which makes PROFIT a clean test of the radiation schedule alone.\n\nThe primary outcome, biochemical or clinical failure, was defined as PSA failure at nadir plus 2, hormonal intervention, local or distant clinical failure, or death from prostate cancer. At a median 6.0 years, 109 of 608 men in the hypofractionated arm and 117 of 598 in the standard arm had an event, most of them PSA failures. Five-year biochemical and clinical failure-free survival was 85 percent in both arms, hazard ratio 0.96 (90 percent confidence interval 0.77 to 1.2), within the non-inferiority margin of 1.32.\n\nTen men in the short arm and 12 in the standard arm died of prostate cancer. No significant difference was detected between arms for grade 3 or worse late genitourinary or gastrointestinal toxicity, which is the contrast with RTOG 0415, where late grade 2 to 3 events did rise.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00304759","url":"https://clinicaltrials.gov/study/NCT00304759"},{"label":"PROFIT (Journal of Clinical Oncology 2017)","url":"https://doi.org/10.1200/JCO.2016.71.7397"}],"tags":[],"related":[],"cancers":["prostate","prostate-intermediate-risk"],"sections":[],"technologies":["hypofractionated-radiotherapy","imrt-igrt"],"targets":[],"drugs":[],"companies":["cctg"],"institutions":[],"pathways":[],"terms":["hypofractionation","curative-intent","psa-kinetics"],"trials":["chhip","rtog-0415","hypo-rt-pc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00304759","phase":"3","setting":"Intermediate-risk localised prostate cancer without androgen deprivation: 60 Gy in 20 fractions over 4 weeks against 78 Gy in 39 fractions over 8 weeks, with biochemical or clinical failure as the primary endpoint and a non-inferiority margin of 7.5 percent","sponsor":"Ontario Clinical Oncology Group with the Canadian Cancer Trials Group","result":"Five-year biochemical and clinical failure-free survival 85 percent in both arms (hazard ratio 0.96, 90 percent confidence interval 0.77 to 1.2); no significant difference in grade 3 or worse late toxicity.","started":"2006-05","yearReported":2017,"enrolled":1206,"enrolledBasis":"randomised","enrolledNote":"1,206 men were randomised, 608 to the hypofractionated arm and 598 to the standard arm.","outcomes":[{"endpoint":"Biochemical or clinical failure-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Hypofractionated, 60 Gy in 20 fractions","n":608,"value":85},{"name":"Conventional, 78 Gy in 39 fractions","n":598,"value":85}],"hr":0.96,"ci":[0.77,1.2],"source":"https://doi.org/10.1200/JCO.2016.71.7397"}],"replication":"CHHiP found the same for 60 Gy in 20 fractions against 74 Gy in 37 fractions in 3,216 men, and RTOG 0415 for 70 Gy in 28 fractions in low-risk disease."},{"id":"profound","kind":"trial","name":"PROfound","aka":[],"tldr":"The first biomarker-selected trial in prostate cancer to improve survival, using a PARP inhibitor in men with BRCA-type mutations.","summary":"PROfound, trial NCT02987543 sponsored by AstraZeneca and Merck and reported in 2020, was the first biomarker-selected trial in prostate cancer to improve survival, using the PARP inhibitor olaparib in men with BRCA1, BRCA2 or ATM alterations. It randomised 387 men with metastatic castration-resistant prostate cancer and homologous recombination repair alterations after an androgen receptor pathway inhibitor to olaparib or a switch to enzalutamide or abiraterone, met its primary radiographic progression-free survival endpoint in cohort A with a large effect, and showed a survival benefit despite crossover, leading to approval in May 2020. OnCo links it to BRCA1 and BRCA2 and PARP as targets, to Maha Hussain and Johann de Bono. Whether ATM and other non-BRCA alterations truly benefit is the open question the cohort structure left behind.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT02987543","url":"https://clinicaltrials.gov/study/NCT02987543"},{"label":"NICE TA887: olaparib for previously treated BRCA mutation-positive hormone-relapsed metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta887"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["parp-inhibitor"],"targets":["brca","parp"],"drugs":["olaparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["prostate-hrr-eligibility","prostate-uk-drug-approvals"],"trials":["triton3","propel"],"people":["maha-hussain","johann-de-bono"],"bottlenecks":[],"keyPapers":["paper-profound-nejm-2020"],"journals":[],"dependsOn":[],"notes":["In England NICE TA887 recommends olaparib within its marketing authorisation for hormone-relapsed metastatic prostate cancer with BRCA1 or BRCA2 mutations that has progressed after a newer hormonal treatment such as abiraterone or enzalutamide, subject to the commercial arrangement. The evaluation updated the cost-effectiveness estimates of TA831 without reviewing new clinical evidence. The committee noted that retreatment with abiraterone or enzalutamide, the comparator in the trial, is not considered effective and is not standard care in the NHS, and that the company provided evidence separately for men who had and had not already had a taxane."],"nct":"NCT02987543","phase":"3","setting":"mCRPC with HRR gene alterations after ARPI: olaparib vs enzalutamide/abiraterone switch","sponsor":"AstraZeneca / Merck","result":"rPFS HR 0.34; OS HR 0.69 (cohort A).","started":"2017-02-06","startedType":"actual","yearReported":2020,"enrolled":387,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic progression-free survival, cohort A (BRCA1/2, ATM)","primary":true,"unit":"months","arms":[{"name":"Olaparib","n":162,"value":7.4},{"name":"Enzalutamide or abiraterone","n":83,"value":3.6}],"hr":0.34,"ci":[0.25,0.47],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1911440"},{"endpoint":"Overall survival, cohort A","unit":"months","arms":[{"name":"Olaparib","value":19.1},{"name":"Enzalutamide or abiraterone","value":14.7}],"hr":0.69,"ci":[0.5,0.97],"p":"0.02","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2022485"}],"replication":"Consistent with TRITON3 (rucaparib in BRCA-altered mCRPC)."},{"id":"nct03478488","kind":"trial","name":"Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC","aka":[],"tldr":"A phase 3 trial of Envafolimab, Gemcitabine and Oxaliplatin in biliary tract cancer, run by 3D Medicines (Sichuan) Co., Ltd., active and no longer recruiting.","summary":"Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC is a phase 3 interventional study registered as NCT03478488 by 3D Medicines (Sichuan) Co., Ltd., with 480 participants enrolled, started 2018-04-16 and due to reach its primary completion in 2024-09-10. Interventions recorded: KN035 plus Gemcitabine & oxaliplatin and Gemcitabine & oxaliplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03478488","url":"https://clinicaltrials.gov/study/NCT03478488"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["envafolimab","gemcitabine","oxaliplatin"],"companies":["3d-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03478488","phase":"3","setting":"Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study","sponsor":"3D Medicines (Sichuan) Co., Ltd.","started":"2018-04-16","startedType":"actual","enrolled":480,"enrolledBasis":"registry","outcomes":[]},{"id":"promid","kind":"trial","name":"PROMID","aka":[],"tldr":"Showed for the first time that a hormone-suppressing injection also slows neuroendocrine tumour growth.","summary":"PROMID, trial NCT00171873 sponsored by Novartis and the German NET study group and reported in 2009, showed for the first time that a hormone-suppressing somatostatin analogue injection also slows neuroendocrine tumour growth. It randomised 85 patients with treatment-naive metastatic midgut neuroendocrine tumours to octreotide LAR or placebo and met its primary endpoint of time to tumour progression with a large effect, while overall survival did not differ because of crossover and a low event rate. OnCo links it to neuroendocrine tumours and to the somatostatin analogues record, and CLARINET extended the antiproliferative effect to lanreotide across enteropancreatic tumours. Whether starting a somatostatin analogue early changes survival, rather than only delaying progression, remains unproven.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00171873","url":"https://clinicaltrials.gov/study/NCT00171873"}],"tags":[],"related":[],"cancers":["neuroendocrine","small-intestinal-net"],"sections":[],"technologies":[],"targets":[],"drugs":["octreotide-lanreotide"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00171873","phase":"3","setting":"Treatment-naive metastatic midgut NETs: octreotide LAR vs placebo","sponsor":"Novartis / German NET study group","result":"TTP 14.3 vs 6.0 months, HR 0.34.","started":"2001-09","yearReported":2009,"enrolled":85,"enrolledBasis":"registry","outcomes":[{"endpoint":"Time to tumour progression","primary":true,"unit":"months","arms":[{"name":"Octreotide LAR","n":42,"value":14.3},{"name":"Placebo","n":43,"value":6}],"hr":0.34,"ci":[0.2,0.59],"source":"https://doi.org/10.1200/JCO.2009.22.8510"}],"replication":"CLARINET extended the antiproliferative effect to lanreotide across enteropancreatic NETs."},{"id":"promis","kind":"trial","name":"PROMIS","aka":["PROstate MRI Imaging Study","ISRCTN16082556"],"tldr":"The British study that measured how bad the standard prostate biopsy really was, and how good a scan could be instead: the evidence that put MRI before the needle in the NHS.","summary":"PROMIS gave 576 men all three tests and compared each against a 5 mm template mapping biopsy taken through the perineum, which is as close to ground truth as a living prostate allows. Defining clinically significant cancer as Gleason 4+3 or worse, or a maximum cancer core length of 6 mm or more, 408 of 576 men (71 percent) had cancer and 230 (40 percent) had clinically significant cancer.\n\nMultiparametric MRI had a sensitivity of 93 percent (95 percent confidence interval 88 to 96) against 48 percent (42 to 55) for transrectal biopsy; the trade was specificity, 41 percent (36 to 46) against 96 percent (94 to 98). Used as a triage test, MRI would let 27 percent of men avoid a primary biopsy altogether, diagnose 5 percent fewer clinically insignificant cancers, and detect up to 18 percent more clinically significant cancers if the biopsies that followed were MRI-directed. Forty-four of 740 men (5.9 percent) had a serious adverse event, including eight cases of sepsis: the harm the scan is there to avoid. NICE NG131 recommendation 1.2.2 now makes multiparametric MRI the first-line investigation for suspected clinically localised prostate cancer, reported on a five-point Likert scale, and box 1 of the guideline quotes PROMIS by name for the numbers a man needs when deciding whether to have a biopsy after a Likert 1 or 2 scan.","status":"positive","asOf":"2026-09-25","links":[{"label":"Lancet 2017","url":"https://europepmc.org/article/MED/28110982"},{"label":"ISRCTN16082556","url":"https://www.isrctn.com/ISRCTN16082556"}],"tags":["uk","prostate","diagnostics"],"related":[],"cancers":["prostate","prostate-low-risk","prostate-intermediate-risk"],"sections":["diagnostics","early-detection"],"technologies":["mri"],"targets":[],"drugs":[],"companies":[],"institutions":["uclh","imperial-cancer-centre"],"pathways":[],"terms":["psa","biopsy"],"trials":[],"people":["hashim-ahmed","mark-emberton","caroline-moore"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN16082556","phase":"observational","setting":"Men with a raised PSA who had never had a biopsy, at eleven UK centres: a paired-cohort validating confirmatory study in which every man had a 1.5-tesla multiparametric MRI, a standard transrectal biopsy and a 5 mm transperineal template mapping biopsy as the reference standard, each read blind to the others; recruiting May 2012 to November 2015","sponsor":"University College London, funded by the NIHR Health Technology Assessment Programme (project 09/22/67)","result":"Multiparametric MRI sensitivity 93 percent against 48 percent for transrectal biopsy, at the cost of specificity (41 against 96 percent); as a triage test it would spare 27 percent of men a biopsy and find up to 18 percent more clinically significant cancers.","yearReported":2017,"enrolled":740,"enrolledBasis":"registered","enrolledNote":"740 men were enrolled and 576 completed all three tests: multiparametric MRI, transrectal ultrasound-guided biopsy and template prostate mapping biopsy.","outcomes":[]},{"id":"propel","kind":"trial","name":"PROpel","aka":[],"tldr":"Showed PARP inhibitor plus abiraterone delays progression in first-line mCRPC, with the largest benefit in BRCA-mutant men.","summary":"PROpel, trial NCT03732820 sponsored by AstraZeneca and Merck and reported in 2022, showed that adding the PARP inhibitor olaparib to abiraterone delays progression in first-line metastatic castration-resistant prostate cancer regardless of mutation status, with the largest benefit in men with BRCA mutations. It randomised 796 unselected men and met its primary radiographic progression-free survival endpoint, but overall survival was not significantly improved in the whole population, so the FDA restricted approval in 2023 to BRCA-mutant disease while the EMA approved the combination for all comers. OnCo links it to BRCA1 and BRCA2 as targets, to olaparib and abiraterone acetate, and its findings are consistent with MAGNITUDE and TALAPRO-2 in HRR-mutant disease. Whether unselected men gain enough to justify the toxicity is the open question, and labels differ by region.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT03732820","url":"https://clinicaltrials.gov/study/NCT03732820"},{"label":"NICE TA951: olaparib with abiraterone for untreated hormone-relapsed metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta951"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["parp-inhibitor"],"targets":["brca"],"drugs":["olaparib","abiraterone"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["prostate-hrr-eligibility","prostate-uk-drug-approvals"],"trials":["talapro-2","magnitude","profound"],"people":[],"bottlenecks":[],"keyPapers":["paper-propel-lancet-oncol-2023"],"journals":[],"dependsOn":[],"notes":["In England NICE TA951 recommends olaparib with abiraterone and prednisone or prednisolone within its marketing authorisation for untreated hormone-relapsed metastatic prostate cancer in adults who cannot have or do not want chemotherapy, subject to the commercial arrangements. The committee noted that usual treatment is abiraterone or enzalutamide, that the trial shows the combination increases how long people live and how long before the cancer worsens compared with abiraterone alone, and that no direct comparison with enzalutamide exists."],"nct":"NCT03732820","phase":"3","setting":"First-line mCRPC, all-comers: abiraterone + olaparib vs abiraterone + placebo","sponsor":"AstraZeneca / Merck","result":"rPFS HR 0.66 (ITT); OS HR 0.81 (NS).","started":"2018-10-31","startedType":"actual","yearReported":2022,"enrolled":796,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 895 participants (actual); 1,103 patients were screened and 796 randomised (399 olaparib, 397 placebo) in the primary analysis.","outcomes":[{"endpoint":"Radiographic progression-free survival (investigator), all comers","primary":true,"unit":"months","arms":[{"name":"Olaparib + abiraterone","n":399,"value":24.8},{"name":"Placebo + abiraterone","n":397,"value":16.6}],"hr":0.66,"ci":[0.54,0.81],"p":"<0.001","source":"https://evidence.nejm.org/doi/full/10.1056/EVIDoa2200043"},{"endpoint":"Overall survival, all comers","unit":"months","arms":[{"name":"Olaparib + abiraterone","value":42.1,"note":"Not significant; larger effect in BRCA-mutant"},{"name":"Placebo + abiraterone","value":34.7}],"hr":0.81,"ci":[0.67,1],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00382-9/fulltext"}],"replication":"Consistent with MAGNITUDE and TALAPRO-2 in HRR-mutant disease; the all-comers benefit is debated and labels differ by region."},{"id":"pci-overview-1999","kind":"trial","name":"Prophylactic Cranial Irradiation Overview (Auperin meta-analysis)","aka":["PCI Overview","Auperin meta-analysis"],"tldr":"Pooling seven trials showed that irradiating the brain before any tumour appears there adds about five people alive in a hundred at three years.","summary":"Small-cell lung cancer seeds the brain early and the blood-brain barrier keeps chemotherapy out, so brain relapse is common even in patients whose chest disease has cleared. Individual trials of prophylactic cranial irradiation each showed fewer brain metastases but none was large enough to show a survival gain. The Prophylactic Cranial Irradiation Overview Collaborative Group pooled individual data on 987 patients in complete remission from seven randomised trials.\n\nThe relative risk of death with irradiation was 0.84 (95 percent confidence interval 0.73 to 0.97, p=0.01), corresponding to three-year survival of 20.7 percent against 15.3 percent, a 5.4 percent absolute gain. Disease-free survival also improved (relative risk of recurrence or death 0.75, 0.65 to 0.86).\n\nThe meta-analysis made prophylactic cranial irradiation standard in limited-stage disease that has responded, and Slotman's EORTC 08993 extended it to extensive-stage disease in 2007. Both are now qualified: the Japanese trial by Takahashi, which required a brain MRI at baseline and three-monthly MRI surveillance afterwards, found no survival benefit and a numerically worse result with irradiation, so in centres that can offer MRI surveillance the choice is genuinely open, and neurocognitive cost is weighed against a benefit measured in a pre-MRI era. Hippocampal avoidance is the current attempt to keep the benefit and lose the cost.","status":"positive","asOf":"2026-09-25","links":[{"label":"Prophylactic Cranial Irradiation Overview (New England Journal of Medicine 1999)","url":"https://doi.org/10.1056/NEJM199908123410703"}],"tags":[],"related":[],"cancers":["limited-stage-sclc","extensive-stage-sclc","sclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["brain-metastases","curative-intent"],"trials":["slotman-pci-es-sclc","takahashi-pci"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"observational","setting":"Small-cell lung cancer in complete remission after chemotherapy, with or without thoracic radiotherapy: prophylactic cranial irradiation versus none, pooled from seven randomised trials, with overall survival as the endpoint","sponsor":"Prophylactic Cranial Irradiation Overview Collaborative Group","result":"Relative risk of death 0.84 (95 percent confidence interval 0.73 to 0.97, p=0.01); three-year survival 20.7 against 15.3 percent.","yearReported":1999,"enrolled":987,"enrolledBasis":"analysed","enrolledNote":"Individual data on 987 patients from seven randomised trials; it is a meta-analysis, not a trial with its own registration.","outcomes":[{"endpoint":"Overall survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Prophylactic cranial irradiation","value":20.7},{"name":"No prophylactic cranial irradiation","value":15.3}],"hr":0.84,"ci":[0.73,0.97],"p":"0.01","source":"https://doi.org/10.1056/NEJM199908123410703"}],"replication":"EORTC 08993 (Slotman) reproduced the effect in extensive-stage disease; the Japanese trial of Takahashi, with MRI surveillance, did not, and is the reason the practice is now a discussion."},{"id":"nct05663775","kind":"trial","name":"Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)","aka":["IMPACT 1"],"tldr":"A phase 2 trial in colorectal cancer, run by AHS Cancer Control Alberta, now recruiting.","summary":"Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo) is a phase 2, interventional study registered as NCT05663775 by AHS Cancer Control Alberta, with a registry enrolment figure of 20 participants, started 2024-08-20 and due to reach its primary completion in 2026-08. Interventions recorded: Mesalamine. Conditions listed: Immune-related Adverse Event; Diarrhea; Advanced Melanoma; Advanced Rectal Carcinoma. Primary outcome: Incidence of Treatment Related Diarrhea; Severity of Treatment Related Diarrhea; Causality of Treatment Related Diarrhea. Colorectal eligibility wording from the registry: \"WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05663775","url":"https://clinicaltrials.gov/study/NCT05663775"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05663775","phase":"2","setting":"Prophylactic Oral Mesalamine for the Prevention of Immune-Related Colitis in Patients Treated With Ipilimumab/Nivolumab","sponsor":"AHS Cancer Control Alberta","started":"2024-08-20","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05939687","kind":"trial","name":"Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection","aka":["ProMeLAR"],"tldr":"A phase 3 trial in colorectal cancer, run by Blokhin's Russian Cancer Research Center, now recruiting.","summary":"Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection is a phase 3, randomised interventional study registered as NCT05939687 by Blokhin's Russian Cancer Research Center, with a registry enrolment figure of 142 participants, started 2023-06-05 and due to reach its primary completion in 2028-12-01. Interventions recorded: mesh; non-mesh. Conditions listed: Neoplasms Malignant; Rectal Cancer; Hernia Incisional; Surgery. Primary outcome: hernia rate. Colorectal eligibility wording from the registry: \"* Integrity of colorectal anastomosis\". Sites: Russia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05939687","url":"https://clinicaltrials.gov/study/NCT05939687"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05939687","phase":"3","setting":"Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial","sponsor":"Blokhin's Russian Cancer Research Center","started":"2023-06-05","startedType":"actual","enrolled":142,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06839092","kind":"trial","name":"Prophylactic PIPAC in Patients With High-risk Colorectal Cancer","aka":["PROPAC"],"tldr":"A phase 3 trial in colorectal cancer, run by Jeremy Meyer, not yet recruiting.","summary":"Prophylactic PIPAC in Patients With High-risk Colorectal Cancer is a phase 3, randomised interventional study registered as NCT06839092 by Jeremy Meyer, with a registry enrolment figure of 160 participants, started 2026-01 and due to reach its primary completion in 2032-01. Interventions recorded: oxaliplatin-based PIPAC; Control (Standard treatment). Conditions listed: Colorectal Cancer Control and Prevention; Colorectal Cancer; Colorectal Cancer Stage II; Colorectal Cancer Stage III. Primary outcome: 1-year peritoneal metastasis-free survival,. Colorectal eligibility wording from the registry: \"* Patients operated (in emergency or elective settings) for colorectal cancer (of the colon, colorectal junction or high rectum)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06839092","url":"https://clinicaltrials.gov/study/NCT06839092"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["hipec"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06839092","phase":"3","setting":"Prophylactic PIPAC for Reducing the Risk of Peritoneal Carcinomatosis in Patients With Colorectal Cancer: the PROPAC Randomized Clinical Trial","sponsor":"Jeremy Meyer","started":"2026-01","startedType":"estimated","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"prophylochip","kind":"trial","name":"PROPHYLOCHIP-PRODIGE 15","aka":[],"tldr":"Reopening the abdomen to look for and wash out invisible disease did not help, and one patient in four had a serious complication.","summary":"PROPHYLOCHIP randomised 150 patients at 23 French hospitals who were at high risk of colorectal peritoneal metastases (resected synchronous localised peritoneal metastases, resected ovarian metastases or a perforated tumour) and who were disease-free after six months of adjuvant chemotherapy, to systematic second-look surgery with oxaliplatin HIPEC or to surveillance. After a median 50.8 months, three-year disease-free survival was 53 percent with surveillance against 44 percent with second-look surgery (hazard ratio 0.97, 95% CI 0.61 to 1.56). Twenty-nine of 71 patients in the surgery group (41 percent) had grade 3 to 4 complications. Standard surveillance is enough.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01226394","url":"https://clinicaltrials.gov/study/NCT01226394"},{"label":"PROPHYLOCHIP-PRODIGE 15: second-look surgery plus HIPEC versus surveillance (Lancet Oncology 2020)","url":"https://doi.org/10.1016/S1470-2045(20)30322-3"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["hipec"],"targets":[],"drugs":["oxaliplatin","irinotecan","mitomycin","fluorouracil"],"companies":[],"institutions":["gustave-roussy"],"pathways":[],"terms":[],"trials":["prodige-7","colopec"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01226394","phase":"3","setting":"Patients at high risk of colorectal peritoneal metastases after resection and six months of adjuvant chemotherapy: systematic second-look surgery with HIPEC against surveillance","sponsor":"Gustave Roussy","result":"Three-year disease-free survival 44 percent with second-look surgery and HIPEC against 53 percent with surveillance.","started":"2010-06-11","startedType":"actual","yearReported":2020,"enrolled":150,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 3 years","primary":true,"unit":"percent","arms":[{"name":"Second-look surgery plus HIPEC","n":75,"value":44},{"name":"Surveillance","n":75,"value":53}],"hr":0.97,"ci":[0.61,1.56],"source":"https://doi.org/10.1016/S1470-2045(20)30322-3"}]},{"id":"nct05741164","kind":"trial","name":"Propranolol and Pembrolizumab for Tumor Re-sensitization and Treatment of Patients With Checkpoint Inhibitor Refractory Metastatic or Unresectable Triple Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of Pembrolizumab and Propranolol in Breast cancer, run by Emory University, now recruiting.","summary":"Propranolol and Pembrolizumab for Tumor Re-sensitization and Treatment of Patients With Checkpoint Inhibitor Refractory Metastatic or Unresectable Triple Negative Breast Cancer is a phase 2 interventional study registered as NCT05741164 by Emory University, with 37 participants planned, started 2024-09-01 and due to reach its primary completion in 2028-06-30. Interventions recorded: Biopsy, Biospecimen Collection, Computed Tomography, Pembrolizumab, Propranolol, Questionnaire Administration. Conditions recorded: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma, Refractory Triple-Negative Breast Carcinoma, Unresectable Triple-Negative Breast Carcinoma.\n\nLinked to the drug Propranolol because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05741164","url":"https://clinicaltrials.gov/study/NCT05741164"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","propranolol-hemangeol"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05741164","phase":"2","setting":"Impact of Beta-2 Adrenergic Blockade With Checkpoint Inhibition in Checkpoint Inhibitor Refractory Metastatic Triple Negative Breast Cancer","sponsor":"Emory University","started":"2024-09-01","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"propsma","kind":"trial","name":"proPSMA","aka":[],"tldr":"Proved PSMA PET is far more accurate than conventional scans for staging, with less radiation.","summary":"proPSMA, registered as ANZCTR12617000005358, sponsored by Peter MacCallum Cancer Centre and ANZUP and reported in the Lancet in 2020, proved that PSMA PET/CT is far more accurate than CT plus bone scan for staging high-risk localised prostate cancer, with less radiation. It randomised 302 men, found an accuracy of 92 percent for PSMA PET against 65 percent for conventional imaging, produced fewer equivocal findings and changed management more often. OnCo links it to PSMA PET, Peter MacCallum, ANZUP, Michael Hofman, Ian Davis and Declan G. Murphy, and its findings are consistent with the OSPREY and CONDOR studies for the fluorine-18 tracer DCFPyL. Whether better staging translates into better outcomes, rather than only different decisions, is the open question that follows any diagnostic accuracy trial. PSMA PET has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"Lancet 2020","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30314-7/fulltext"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":["psma-pet"],"targets":[],"drugs":[],"companies":["anzup"],"institutions":["peter-mac"],"pathways":[],"terms":[],"trials":[],"people":["ian-davis","declan-murphy","hofman-michael"],"bottlenecks":[],"keyPapers":["paper-propsma-hofman-lancet-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"ANZCTR12617000005358","phase":"3","setting":"High-risk localised prostate cancer staging: PSMA PET/CT vs CT + bone scan","sponsor":"Peter MacCallum Cancer Centre / ANZUP","result":"Accuracy 92% vs 65%.","yearReported":2020,"enrolled":302,"enrolledBasis":"registry","outcomes":[{"endpoint":"Accuracy for pelvic nodal or distant metastases (AUC)","primary":true,"unit":"%","arms":[{"name":"PSMA PET/CT","n":150,"value":92},{"name":"CT + bone scan","n":152,"value":65}],"p":"<0.0001","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30314-7/fulltext"}],"replication":"Consistent with the OSPREY and CONDOR registrational studies for 18F-DCFPyL."},{"id":"proselica","kind":"trial","name":"PROSELICA","aka":["PROSELICA","cabazitaxel 20 against 25 mg/m2"],"tldr":"A lower dose of cabazitaxel works nearly as well and causes far fewer serious side effects, which is why most men now start on the lower dose.","summary":"PROSELICA randomised 1,200 men with metastatic castration-resistant prostate cancer after docetaxel to cabazitaxel 20 mg/m2 (598) or 25 mg/m2 (602), stratified by ECOG performance status, measurability of disease and region. Non-inferiority required the upper bound of the hazard ratio confidence interval for the lower dose to stay below 1.214, which corresponds to keeping at least half the survival advantage cabazitaxel had over mitoxantrone in TROPIC.\n\nMedian overall survival was 13.4 months at 20 mg/m2 and 14.5 months at 25 mg/m2, hazard ratio 1.024 with an upper bound of 1.184: non-inferiority was met.\n\nThe efficacy secondary endpoints favoured the higher dose. PSA response occurred in 29.5 percent at 20 mg/m2 against 42.9 percent at 25 mg/m2 (nominal p<0.001), and median time to PSA progression was 5.7 against 6.8 months, hazard ratio 1.195 (95 percent confidence interval 1.025 to 1.393). Health-related quality of life did not differ.\n\nThe safety endpoint is why the trial changed practice: grade 3 or 4 treatment-emergent adverse events occurred in 39.7 percent at 20 mg/m2 against 54.5 percent at 25 mg/m2. For an older or frailer man the lower dose is the reasonable default, and the trade-off, a poorer PSA response for a substantially lower chance of a serious event, is one worth stating to him.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01308580","url":"https://clinicaltrials.gov/study/NCT01308580"},{"label":"PROSELICA (Journal of Clinical Oncology 2017)","url":"https://doi.org/10.1200/JCO.2016.72.1076"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cabazitaxel","prednisone"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":["castration-resistance","psa50","qol-pro"],"trials":["tropic","firstana","card"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01308580","phase":"3","setting":"Metastatic castration-resistant prostate cancer after docetaxel: cabazitaxel 20 mg/m2 against 25 mg/m2, with a non-inferiority design requiring the lower dose to keep at least half the survival benefit cabazitaxel showed against mitoxantrone in TROPIC","sponsor":"Sanofi","result":"Median overall survival 13.4 months at cabazitaxel 20 mg/m2 against 14.5 months at 25 mg/m2 (hazard ratio 1.024, upper bound 1.184, non-inferior); grade 3 or 4 adverse events 39.7 against 54.5 percent, PSA response 29.5 against 42.9 percent.","started":"2011-04","yearReported":2017,"enrolled":1200,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Cabazitaxel 20 mg/m2","n":598,"value":13.4,"note":"Upper bound of the confidence interval 1.184, below the non-inferiority margin of 1.214."},{"name":"Cabazitaxel 25 mg/m2","n":602,"value":14.5}],"hr":1.024,"source":"https://doi.org/10.1200/JCO.2016.72.1076"},{"endpoint":"Grade 3 or 4 treatment-emergent adverse events","unit":"%","arms":[{"name":"Cabazitaxel 20 mg/m2","n":598,"value":39.7},{"name":"Cabazitaxel 25 mg/m2","n":602,"value":54.5}],"source":"https://doi.org/10.1200/JCO.2016.72.1076"},{"endpoint":"PSA response","unit":"%","arms":[{"name":"Cabazitaxel 20 mg/m2","n":598,"value":29.5},{"name":"Cabazitaxel 25 mg/m2","n":602,"value":42.9}],"p":"<0.001 nominal","source":"https://doi.org/10.1200/JCO.2016.72.1076"}],"replication":"Confirms the efficacy of cabazitaxel established in TROPIC at a lower dose; FIRSTANA, run in parallel, showed cabazitaxel is not superior to docetaxel in the first line."},{"id":"prospect-prostvac","kind":"trial","name":"PROSPECT","aka":["PROSPECT","BNIT-PRV-301","PROSTVAC phase 3"],"tldr":"The prostate cancer vaccine that looked like it added eight and a half months of life in a small trial added nothing in a big one.","summary":"PROSPECT randomised 1,297 men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer to PROSTVAC (432), PROSTVAC with granulocyte-macrophage colony-stimulating factor (432) or placebo (433), with three planned interim analyses.\n\nAt the third interim analysis the futility criteria were met and the trial stopped early. Neither active arm affected overall survival: median 34.4 months with PROSTVAC, hazard ratio 1.01 (95 percent confidence interval 0.84 to 1.20, p=0.47); 33.2 months with the granulocyte-macrophage colony-stimulating factor combination, 1.02 (0.86 to 1.22, p=0.59); and 34.3 months with placebo. Patients alive without radiographic progression, pain progression, chemotherapy initiation or death at 6 months were 29.4, 28.0 and 30.3 percent respectively.\n\nAdverse events were similar across arms, injection site reactions in 62 to 72 percent and fatigue in 21 to 24 percent, with arrhythmias the commonest cardiac event at 1.4 to 3.5 percent. No myocarditis or pericarditis was reported and serious treatment-related events occurred in under 1 percent of all patients.\n\nThe phase 2 result that justified the trial had reported a median overall survival 8.5 months longer than placebo. In PROSPECT the placebo arm lived 34.3 months, far longer than the phase 2 control, which is the likeliest explanation: the earlier comparison was against an unrepresentatively poor control group.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01322490","url":"https://clinicaltrials.gov/study/NCT01322490"},{"label":"PROSPECT (Journal of Clinical Oncology 2019)","url":"https://doi.org/10.1200/JCO.18.02031"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["shared-antigen-vaccine"],"targets":[],"drugs":["prostvac"],"companies":["bavarian-nordic"],"institutions":[],"pathways":[],"terms":["castration-resistance","psa"],"trials":["impact-sipuleucel-t","ca184-043-ipilimumab"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01322490","phase":"3","setting":"Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer, stratified by PSA (below or at least 50 ng/mL) and lactate dehydrogenase (below or at least 200 U/L): PROSTVAC, PROSTVAC with granulocyte-macrophage colony-stimulating factor, or placebo, with overall survival as the primary endpoint","sponsor":"Bavarian Nordic","result":"Median overall survival 34.4 months with PROSTVAC (hazard ratio 1.01), 33.2 months with PROSTVAC and granulocyte-macrophage colony-stimulating factor (1.02) and 34.3 months with placebo; stopped early for futility.","started":"2011-11-28","startedType":"actual","yearReported":2019,"enrolled":1297,"enrolledBasis":"randomised","enrolledNote":"1,297 men were randomised across three arms: 432 to PROSTVAC, 432 to PROSTVAC with granulocyte-macrophage colony-stimulating factor and 433 to placebo.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"PROSTVAC","n":432,"value":34.4,"note":"Hazard ratio is PROSTVAC against placebo; the combination arm gave 1.02 (0.86 to 1.22, p=0.59)."},{"name":"PROSTVAC with granulocyte-macrophage colony-stimulating factor","n":432,"value":33.2},{"name":"Placebo","n":433,"value":34.3}],"hr":1.01,"ci":[0.84,1.2],"p":"0.47","source":"https://doi.org/10.1200/JCO.18.02031"}],"replication":"Sipuleucel-T, the only prostate cancer vaccine ever approved, did extend survival in IMPACT (25.8 against 21.7 months); its guidance in England, NICE TA332, has since been withdrawn because the marketing authorisation was withdrawn."},{"id":"prospect","kind":"trial","name":"PROSPECT (Alliance N1048)","aka":[],"tldr":"PROSPECT showed that most people with intermediate-risk rectal cancer can skip pelvic radiotherapy altogether: chemotherapy alone before surgery, with radiotherapy held back for the few whose tumours did not shrink, cured just as many.","summary":"PROSPECT randomised 1,194 patients with rectal cancer that was locally advanced but not threatening the mesorectal fascia or the sphincter to six cycles of neoadjuvant FOLFOX, with chemoradiation given only if the tumour shrank by less than 20 percent, or to standard fluoropyrimidine chemoradiation. Both groups then had total mesorectal excision and adjuvant chemotherapy.\n\nFive-year disease-free survival was 80.8 percent with FOLFOX and 78.6 percent with chemoradiation, meeting the non-inferiority margin; only 9 percent of the FOLFOX group needed chemoradiation. Local recurrence and overall survival were no different, and patient-reported bowel, sexual and neuropathy outcomes favoured different arms at different times.\n\nThe trial removed radiotherapy from the default pathway for a large group of rectal cancer patients and, with RAPIDO, PRODIGE 23 and OPRA, made the treatment of rectal cancer a choice of sequences tailored to risk and to the goal of organ preservation.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01515787","url":"https://clinicaltrials.gov/study/NCT01515787"},{"label":"New England Journal of Medicine 2023","url":"https://doi.org/10.1056/NEJMoa2303269"}],"tags":[],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["folfox","fluorouracil","capecitabine"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":["chemoradiation","total-mesorectal-excision"],"trials":["iwwd","dutch-tme-trial","cao-aro-aio-12"],"people":[],"bottlenecks":[],"keyPapers":["paper-prospect-nejm-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01515787","phase":"2/3","setting":"cT2 node-positive, cT3 node-negative or cT3 node-positive rectal cancer suitable for sphincter-sparing surgery: FOLFOX with chemoradiation only for poor responders, versus standard pelvic chemoradiation before surgery","sponsor":"Alliance for Clinical Trials in Oncology / NCI","result":"5-year disease-free survival 80.8% (FOLFOX, selective chemoradiation) vs 78.6% (chemoradiation), non-inferior; 9% of the FOLFOX arm received chemoradiation.","started":"2012-06-12","startedType":"actual","yearReported":2023,"enrolled":1194,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"FOLFOX with selective chemoradiation","n":585,"value":80.8},{"name":"Chemoradiation","n":543,"value":78.6}],"hr":0.92,"source":"https://doi.org/10.1056/NEJMoa2303269"}],"replication":"The Chinese FOWARC trial had earlier reported similar disease control with FOLFOX alone; national guidelines in the US and Europe added the chemotherapy-first option in 2023 and 2024."},{"id":"nct07103447","kind":"trial","name":"Prospective Multicenter Single-arm Trial: AK112 + Nab-paclitaxel/Carboplatin Neoadjuvant for TNBC","aka":[],"tldr":"A phase 2 trial of ivonescimab and carboplatin in triple-negative breast cancer, run by Shuangyue Liu, not yet recruiting.","summary":"Prospective Multicenter Single-arm Trial: AK112 + Nab-paclitaxel/Carboplatin Neoadjuvant for TNBC is a phase 2, interventional study registered as NCT07103447 by Shuangyue Liu, with a registry enrolment figure of 54 participants, started 2025-09-10 and due to reach its primary completion in 2027-12-31. Interventions recorded: AK112, Carboplatin, Paxlitaxel. Conditions listed: Breast Cancer - Female. Triple-negative eligibility wording from the registry: \"Pathological Confirmation of Disease: Histopathologically confirmed diagnosis of T1-4N0-3M0 (except for T1N0M0) triple-negative invasive breast cancer, defined as negative for estrogen receptor (ER) and progesterone receptor (PgR) (immunohistochemistry: ER, PR \\< 1%), and human epidermal growth fact\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07103447","url":"https://clinicaltrials.gov/study/NCT07103447"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["ivonescimab","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07103447","phase":"2","setting":"A Prospective, Multicenter, Single-Arm Study of AK112 in Combination With Albumin-Bound Paclitaxel and Carboplatin as Neoadjuvant Treatment for Triple-Negative Breast Cancer","sponsor":"Shuangyue Liu","started":"2025-09-10","startedType":"estimated","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06745882","kind":"trial","name":"Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC","aka":[],"tldr":"A phase 2 trial of cisplatin, carboplatin, pemetrexed, pembrolizumab and other drugs in lung cancer, run by H. Lee Moffitt Cancer Center and Research Institute, now recruiting.","summary":"Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC is a phase 2, interventional study registered as NCT06745882 by H. Lee Moffitt Cancer Center and Research Institute, with a registry enrolment figure of 318 participants, started 2025-06-13 and due to reach its primary completion in 2030-01. Interventions recorded: Cisplatin; Carboplatin; Pemetrexed; Pembrolizumab; Abraxane; Paclitaxel. Conditions listed: Non-small Cell Lung Cancer. Primary outcome: Cohort 1: Real World Overall Survival (rwOS); Cohort 2 Arm A: Progression Free Survival (PFS); Cohort 2 Arm B: Progression Free Survival (PFS). Lung eligibility wording from the registry: \"* Have histologically or cytologically confirmed, advanced/metastatic NSCLC\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06745882","url":"https://clinicaltrials.gov/study/NCT06745882"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin","carboplatin","pemetrexed","pembrolizumab","nab-paclitaxel","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06745882","phase":"2","setting":"Prospective Trial to Assess Real-world Outcomes and Predictive Biomarkers of Response to Pembrolizumab With or Without Chemotherapy in Black Patients With NSCLC","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","started":"2025-06-13","startedType":"actual","enrolled":318,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03671252","kind":"trial","name":"Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Co","aka":[],"tldr":"A phase 3 trial of FOLFOXIRI and cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation is a phase 3, randomised interventional study registered as NCT03671252 by Sun Yat-sen University, with a registry enrolment figure of 776 participants, started 2018-11-16 and due to reach its primary completion in 2025-09-25. Interventions recorded: FOLFOXIRI; XELOX; Chemoradiotherapy; TME operation; efficacy evaluation. Conditions listed: Rectal Cancer. Primary outcome: 3-year disease free survival rate. Colorectal eligibility wording from the registry: \"* 2）Histological diagnosis of rectal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03671252","url":"https://clinicaltrials.gov/study/NCT03671252"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfoxiri","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03671252","phase":"3","setting":"Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation","sponsor":"Sun Yat-sen University","started":"2018-11-16","startedType":"actual","enrolled":776,"enrolledBasis":"registry","outcomes":[]},{"id":"prosper","kind":"trial","name":"PROSPER","aka":[],"tldr":"PROSPER showed that enzalutamide delayed the appearance of metastases by about two years, and later helped men live longer, when given at the point where prostate cancer is rising on hormone therapy but has not yet spread on scans.","summary":"PROSPER randomised 1401 men with castration-resistant prostate cancer, no metastases on conventional imaging and a PSA doubling time of ten months or less two to one to enzalutamide or placebo alongside androgen deprivation. The primary endpoint was metastasis-free survival.\n\nEnzalutamide lengthened metastasis-free survival substantially and delayed the time to PSA progression and to further antineoplastic therapy; with longer follow-up overall survival was also improved. Fatigue, hypertension and falls were the main added toxicities. It was approved for this indication in July 2018 and, with SPARTAN (apalutamide) and ARAMIS (darolutamide), defined androgen receptor pathway inhibition as the standard for high-risk non-metastatic castration-resistant disease, a group that PSMA PET imaging has since shrunk.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02003924","url":"https://clinicaltrials.gov/study/NCT02003924"},{"label":"NICE TA580: enzalutamide for hormone-relapsed non-metastatic prostate cancer, not recommended","url":"https://www.nice.org.uk/guidance/ta580"}],"tags":["subtype-trials"],"related":[],"cancers":["prostate-nmcrpc","prostate"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["enzalutamide"],"companies":["pfizer","astellas"],"institutions":[],"pathways":[],"terms":["prostate-uk-drug-approvals","metastasis-free-survival"],"trials":["nct01946204","aramis"],"people":["maha-hussain"],"bottlenecks":[],"keyPapers":["paper-prosper-nejm-2018"],"journals":[],"dependsOn":[],"notes":["In England NICE TA580 does not recommend enzalutamide for high-risk hormone-relapsed non-metastatic prostate cancer. The committee accepted that adding enzalutamide extends the time until the cancer starts spreading but found no evidence that it increases how long people live, and judged the cost-effectiveness estimates uncertain because survival on enzalutamide could not be estimated accurately and because the costs and benefits of subsequent treatments in the economic analysis did not reflect NHS practice. Apalutamide (TA740) and darolutamide (TA660) are recommended in the same population."],"nct":"NCT02003924","phase":"3","setting":"Non-metastatic castration-resistant prostate cancer with a PSA doubling time of ten months or less: enzalutamide against placebo, both with continued androgen deprivation","sponsor":"Pfizer (Medivation) and Astellas","result":"Enzalutamide lengthened metastasis-free survival and, with longer follow-up, overall survival compared with placebo; approved in July 2018.","started":"2013-10-31","startedType":"actual","yearReported":2018,"enrolled":1401,"enrolledBasis":"registry","outcomes":[{"endpoint":"Metastasis-free survival","primary":true,"unit":"months","arms":[{"name":"Enzalutamide","n":933,"value":36.6},{"name":"Placebo","n":468,"value":14.7}],"hr":0.29,"ci":[0.24,0.35],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1800536"},{"endpoint":"Time to PSA progression","unit":"months","arms":[{"name":"Enzalutamide","n":933,"value":37.2},{"name":"Placebo","n":468,"value":3.9}],"hr":0.07,"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1800536"},{"endpoint":"Time to first subsequent antineoplastic therapy","unit":"months","arms":[{"name":"Enzalutamide","n":933,"value":39.6},{"name":"Placebo","n":468,"value":17.7}],"hr":0.21,"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1800536"},{"endpoint":"Grade 3 or higher adverse events","unit":"%","arms":[{"name":"Enzalutamide","value":31},{"name":"Placebo","value":23}],"source":"https://doi.org/10.1056/NEJMoa1800536"}]},{"id":"nct00567580","kind":"trial","name":"Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer","aka":["SPPORT","NRG Oncology RTOG 0534"],"tldr":"A phase 3 trial of Flutamide, Bicalutamide, Goserelin / leuprolide, Buserelin and Triptorelin in Prostate cancer, run by Radiation Therapy Oncology Group, with a status the registry has not verified recently.","summary":"Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer is a phase 3 interventional study registered as NCT00567580 by Radiation Therapy Oncology Group, with 1792 participants planned, started 2008-02 and due to reach its primary completion in 2018-07-12. Interventions recorded: PBRT, PLNRT, AA, LHRH agonist. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Buserelin because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00567580","url":"https://clinicaltrials.gov/study/NCT00567580"},{"label":"SPPORT / NRG Oncology RTOG 0534 (Lancet 2022)","url":"https://doi.org/10.1016/S0140-6736(21)01790-6"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-bcr"],"sections":[],"technologies":[],"targets":[],"drugs":["flutamide","bicalutamide","goserelin","buserelin","triptorelin"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":["getug-afu-16","radicals-hd","rtog-9601"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["SPPORT was run at 283 radiation oncology centres in the United States, Canada and Israel between 31 March 2008 and 30 March 2015, enrolling men with a persistently detectable or initially undetectable and rising PSA of 0.1 to 2.0 ng/mL after prostatectomy, pT2 or pT3 disease and a Gleason score of 9 or less. Prostate bed radiotherapy was 64.8 to 70.2 Gy at 1.8 Gy per fraction; pelvic nodal radiotherapy was 45 Gy at 1.8 Gy per fraction before a volume reduction for the remaining 19.8 to 25.2 Gy. Of 1,792 enrolled men, 76 were later found ineligible, leaving 1,716 evaluable.\n\nAt the interim analysis of 1,191 men the Haybittle-Peto boundary of p<0.001 was exceeded comparing group 1 with group 3 (difference 17.9 percent, standard error 2.9, p<0.0001); the difference between groups 2 and 3 did not exceed the boundary (p=0.0063). Late toxicity beyond 3 months did not differ significantly between groups, apart from more late grade 2 or worse blood or bone marrow events in group 3 than group 2 (one-sided p=0.0060), attributable to the nodal radiotherapy (Lancet 2022)."],"nct":"NCT00567580","phase":"3","setting":"A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy","sponsor":"Radiation Therapy Oncology Group","result":"Five-year freedom from progression after prostatectomy 70.9 percent with prostate bed radiotherapy alone, 81.3 percent with added short-term androgen deprivation and 87.4 percent with pelvic nodal radiotherapy as well.","started":"2008-02","yearReported":2022,"enrolled":1792,"enrolledBasis":"registry","outcomes":[{"endpoint":"Freedom from progression at 5 years","primary":true,"unit":"%","arms":[{"name":"Prostate bed radiotherapy alone","n":592,"value":70.9,"note":"Analysed in 1,716 eligible men at a median 8.2 years among survivors; group 3 was superior to groups 1 and 2 per protocol."},{"name":"Prostate bed radiotherapy with short-term androgen deprivation","n":602,"value":81.3},{"name":"Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation","n":598,"value":87.4}],"source":"https://doi.org/10.1016/S0140-6736(21)01790-6"},{"endpoint":"Acute grade 2 or worse adverse events within 3 months","unit":"%","arms":[{"name":"Prostate bed radiotherapy alone","n":547,"value":18,"note":"Group 3 against group 2 p=0.0034; group 2 against group 1 p<0.0001."},{"name":"Prostate bed radiotherapy with short-term androgen deprivation","n":563,"value":36},{"name":"Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation","n":563,"value":44}],"source":"https://doi.org/10.1016/S0140-6736(21)01790-6"}],"replication":"GETUG-AFU 16 showed the androgen deprivation component independently, raising 120-month progression-free survival from 49 to 64 percent with 6 months of goserelin."},{"id":"protect","kind":"trial","name":"ProtecT","aka":[],"tldr":"Showed that men with screen-detected prostate cancer die of it rarely, whether monitored or treated, establishing active surveillance.","summary":"ProtecT, trial NCT02044172 sponsored by the UK National Institute for Health Research through Oxford and Bristol, showed that men with PSA-detected localised prostate cancer rarely die of it over fifteen years whether monitored, operated on or irradiated, and it established active surveillance as a legitimate choice. It randomised 1,643 men to active monitoring, prostatectomy or radiotherapy; at fifteen years prostate cancer mortality was low and not significantly different between arms, treatment roughly halved metastasis at the cost of side effects, and about sixty percent of monitored men were eventually treated. OnCo links it to active surveillance, MRI-first screening, Freddie C. Hamdy and the bottleneck of overdiagnosis. Whether modern MRI and biomarkers can pick out the minority who need treatment from the start is the open question.","status":"completed","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT02044172","url":"https://clinicaltrials.gov/study/NCT02044172"},{"label":"ProtecT 15-year outcomes (New England Journal of Medicine 2023)","url":"https://doi.org/10.1056/NEJMoa2214122"},{"label":"ProtecT 10-year outcomes (New England Journal of Medicine 2016)","url":"https://doi.org/10.1056/NEJMoa1606220"},{"label":"ProtecT patient-reported outcomes (New England Journal of Medicine 2016)","url":"https://doi.org/10.1056/NEJMoa1606221"},{"label":"ISRCTN registry ISRCTN20141297","url":"https://www.isrctn.com/ISRCTN20141297"}],"tags":[],"related":[],"cancers":["prostate","prostate-low-risk","prostate-intermediate-risk"],"sections":[],"technologies":["active-surveillance"],"targets":[],"drugs":[],"companies":[],"institutions":["oxford-cancer","bristol-haematology-oncology-centre"],"pathways":[],"terms":["prostate-treatment-choice-localised"],"trials":["pivot","spcg-4","pace-b"],"people":["freddie-hamdy","jenny-donovan"],"bottlenecks":[],"keyPapers":["paper-protect-nejm-2016","paper-protect-bju-int-2026-update"],"journals":[],"dependsOn":[],"notes":["At 15 years (range 11 to 21), follow-up was complete for 1,610 of 1,643 men (98 percent) and more than a third had intermediate-risk or high-risk disease at diagnosis. Death from any cause occurred in 356 men (21.7 percent), similar across groups. Long-term androgen deprivation was started in 69 monitored men (12.7 percent), 40 after surgery (7.2 percent) and 42 after radiotherapy (7.7 percent). In the active-monitoring group 133 men (24.4 percent) were alive at the end of follow-up without any prostate cancer treatment. No treatment complications were reported after the 10-year analysis (New England Journal of Medicine 2023).","The 10-year analysis reported 17 prostate cancer deaths in total, eight under monitoring, five after surgery and four after radiotherapy (p=0.48), with metastases in 33, 13 and 16 men respectively (p=0.004) and disease progression in 112, 46 and 46 (p<0.001) (New England Journal of Medicine 2016).","The patient-reported outcomes, collected before diagnosis, at 6 and 12 months and annually to 6 years with completion above 85 percent for most measures, are what make the trial usable in a consultation. Prostatectomy had the greatest negative effect on sexual function and urinary continence, and both remained worse than the other groups throughout despite some recovery. Radiotherapy's effect on sexual function was worst at 6 months, partly recovered, then stable, and it had little effect on urinary continence; bowel function was worse at 6 months and partly recovered except for increasingly frequent bloody stools. Sexual and urinary function declined gradually under active monitoring. No significant differences were seen between groups in anxiety, depression, or general or cancer-related quality of life (New England Journal of Medicine 2016)."],"nct":"NCT02044172","phase":"3","setting":"PSA-detected localised prostate cancer: active monitoring vs prostatectomy vs radiotherapy","sponsor":"UK NIHR (Oxford, Bristol)","result":"15-year prostate-cancer mortality 3.1% (monitoring), 2.2% (surgery), 2.9% (radiotherapy); no significant difference.","started":"2001-06-01","startedType":"actual","yearReported":2016,"enrolled":1643,"enrolledBasis":"randomised","enrolledNote":"82,429 men aged 50 to 69 had a PSA test, 2,664 were diagnosed with localised prostate cancer and 1,643 were randomised; NCT02044172 records the trial rather than the screening population.","outcomes":[{"endpoint":"Prostate-cancer-specific mortality at 15 years","primary":true,"unit":"%","arms":[{"name":"Active monitoring","n":545,"value":3.1,"note":"No significant difference between arms"},{"name":"Prostatectomy","n":553,"value":2.2},{"name":"Radiotherapy","n":545,"value":2.9}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2214122"},{"endpoint":"Death from prostate cancer at 15 years","primary":true,"unit":"%","arms":[{"name":"Active monitoring","n":545,"value":3.1},{"name":"Radical prostatectomy","n":553,"value":2.2},{"name":"Radical radiotherapy","n":545,"value":2.9}],"p":"0.53","source":"https://doi.org/10.1056/NEJMoa2214122"},{"endpoint":"Metastases at 15 years","unit":"men","arms":[{"name":"Active monitoring","n":545,"value":51},{"name":"Radical prostatectomy","n":553,"value":26},{"name":"Radical radiotherapy","n":545,"value":27}],"source":"https://doi.org/10.1056/NEJMoa2214122"},{"endpoint":"Clinical progression at 15 years","unit":"men","arms":[{"name":"Active monitoring","n":545,"value":141},{"name":"Radical prostatectomy","n":553,"value":58},{"name":"Radical radiotherapy","n":545,"value":60}],"source":"https://doi.org/10.1056/NEJMoa2214122"}],"replication":"Consistent with PIVOT and SPCG-4 in showing very low mortality from low- and intermediate-risk disease under conservative management."},{"id":"nct07736495","kind":"trial","name":"Protective Role of Alpha-Lipoic Acid in Chemotherapy-Induced Mucositis","aka":[],"tldr":"A phase 2/3 trial in colorectal cancer, run by Ain Shams University, now recruiting.","summary":"Protective Role of Alpha-Lipoic Acid in Chemotherapy-Induced Mucositis is a phase 2/3, randomised interventional study registered as NCT07736495 by Ain Shams University, with a registry enrolment figure of 50 participants, started 2026-07-27 and due to reach its primary completion in 2026-12-27. Interventions recorded: alpha lipoic acid 600 mg twice daily; Placebo Tablet. Conditions listed: Colorectal Cancer. Primary outcome: Serum levels of malondialdehyde (MDA). Sites: Egypt. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07736495","url":"https://clinicaltrials.gov/study/NCT07736495"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07736495","phase":"2/3","setting":"Evaluation of the Protective Effect of Alpha-Lipoic Acid Against 5-Fluorouracil-Induced Oral Mucositis in Colorectal Cancer Patients","sponsor":"Ain Shams University","started":"2026-07-27","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07825753","kind":"trial","name":"Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer","aka":["PROBE"],"tldr":"A phase 2 trial of trastuzumab emtansine, trastuzumab deruxtecan, datopotamab deruxtecan, sacituzumab govitecan and other drugs in pancreatic cancer, run by Fudan University, not yet recruiting.","summary":"Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer is a phase 2, interventional study registered as NCT07825753 by Fudan University, with a registry enrolment figure of 225 participants, started 2026-09-10 and due to reach its primary completion in 2027-09-01. Interventions recorded: Trastuzumab emtansine (T-DM1); Trastuzumab deruxtecan (T-DXd); Datopotamab deruxtecan (Dato-DXd); Sacituzumab govitecan (SG); Enfortumab vedotin (EV); Becotatug vedotin (MRG003); Izalontamab brengitecan (iza-bren / BL-B01D1); Mirvetuximab soravtansine (MIRV). Conditions listed: Advanced or Metastatic Pancreatic Adenocarcinoma; Advanced or Metastatic Breast Cancer (BC). Primary outcome: Objective Response Rate (ORR) as Assessed by RECIST 1.1. Pancreatic eligibility wording from the registry: \"Histologically confirmed recurrent (unresectable) or metastatic advanced pancreatic cancer or breast cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07825753","url":"https://clinicaltrials.gov/study/NCT07825753"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-emtansine","trastuzumab-deruxtecan","datopotamab-deruxtecan","sacituzumab-govitecan","enfortumab-vedotin","izalontamab-brengitecan","mirvetuximab-soravtansine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07825753","phase":"2","setting":"An Umbrella Clinical Trial of Antibody/Peptide-Drug Conjugates Matched by Mass Spectrometry-Based Absolute Quantitation of Proteins in Locally Advanced or Metastatic Pancreatic or Breast Cancer","sponsor":"Fudan University","started":"2026-09-10","startedType":"estimated","enrolled":225,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02598349","kind":"trial","name":"Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas","aka":[],"tldr":"A phase 2 trial of capecitabine in pancreatic cancer, run by Proton Collaborative Group, now recruiting.","summary":"Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas is a phase 2, interventional study registered as NCT02598349 by Proton Collaborative Group, with a registry enrolment figure of 60 participants, started 2016-04 and due to reach its primary completion in 2039-10. Interventions recorded: Proton Radiation; Capecitabine; Surgical resection. Conditions listed: Pancreatic Cancer. Primary outcome: Overall survival at 12 months after radiation therapy. Pancreatic eligibility wording from the registry: \"* Biopsy proven unresectable adenocarcinoma of the pancreas\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02598349","url":"https://clinicaltrials.gov/study/NCT02598349"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","locally-advanced-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02598349","phase":"2","setting":"A Phase II Trial of Escalated Dose Proton Radiotherapy With Elective Nodal Irradiation and Concomitant Chemotherapy for Patients With Unresectable, Borderline Resectable or Medically Inoperable Pancreatic Adenocarcinoma","sponsor":"Proton Collaborative Group","started":"2016-04","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"proud-pv","kind":"trial","name":"PROUD-PV and CONTINUATION-PV","aka":[],"tldr":"PROUD-PV and its extension showed that ropeginterferon matches hydroxyurea in the first year and then pulls ahead, with more complete responses and far more molecular responses by three years.","summary":"PROUD-PV randomised 257 patients with PV to ropeginterferon alfa-2b every two weeks or hydroxyurea; CONTINUATION-PV followed 171 of them. Non-inferiority for complete haematological response at 12 months was not formally shown, but from 24 months onward the interferon arm had more complete haematological responses with improved disease burden and a much higher rate of molecular response, with the JAK2 V617F allele burden falling steadily over years (Gisslinger and colleagues, Lancet Haematology 2020). The trials underpinned the EU approval in 2019 and the FDA approval in 2021.","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01949805","url":"https://clinicaltrials.gov/study/NCT01949805"},{"label":"ClinicalTrials.gov NCT02218047","url":"https://clinicaltrials.gov/study/NCT02218047"},{"label":"Lancet Haematology 2020","url":"https://doi.org/10.1016/S2352-3026(19)30236-4"}],"tags":["polycythaemia-vera","mpn"],"related":[],"cancers":["polycythaemia-vera","myeloproliferative-neoplasms"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["ropeginterferon-alfa-2b","hydroxyurea"],"companies":["pharmaessentia"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-gisslinger-lancet-haematol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01949805","phase":"3","setting":"Polycythaemia vera needing cytoreduction: ropeginterferon alfa-2b versus hydroxyurea, with long-term follow-up","sponsor":"AOP Orphan Pharmaceuticals","result":"By 36 months, complete haematological response with improved disease burden and molecular response were both more frequent with ropeginterferon than hydroxyurea.","started":"2013-09","yearReported":2020,"enrolled":257,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete haematological response with normal spleen size at 12 months (PROUD-PV)","primary":true,"unit":"%","arms":[{"name":"Ropeginterferon alfa-2b","n":122,"value":21,"note":"Non-inferiority to hydroxyurea not shown at 12 months"},{"name":"Hydroxyurea","n":123,"value":28}],"source":"https://doi.org/10.1016/S2352-3026(19)30236-4"},{"endpoint":"Complete haematological response with improved disease burden at 36 months (CONTINUATION-PV)","primary":true,"unit":"%","arms":[{"name":"Ropeginterferon alfa-2b","n":95,"value":53},{"name":"Hydroxyurea","n":74,"value":38}],"p":"0.044","source":"https://doi.org/10.1016/S2352-3026(19)30236-4"},{"endpoint":"Complete haematological response at 36 months (without the spleen criterion)","unit":"%","arms":[{"name":"Ropeginterferon alfa-2b","n":95,"value":71},{"name":"Hydroxyurea","n":74,"value":51}],"p":"0.012","source":"https://doi.org/10.1016/S2352-3026(19)30236-4"}]},{"id":"nct07072728","kind":"trial","name":"Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder","aka":[],"tldr":"A phase 2 trial of Psilocybin therapy in endometrial cancer, prostate cancer, gastric & gastro-oesophageal junction cancer, melanoma and pancreatic ductal adenocarcinoma, run by Psyence Australia Pty Ltd, now recruiting.","summary":"Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder is a phase 2 interventional study registered as NCT07072728 by Psyence Australia Pty Ltd, with 87 participants planned, started 2025-10-01 and due to reach its primary completion in 2026-12-30. Interventions recorded: Psilocybin therapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07072728","url":"https://clinicaltrials.gov/study/NCT07072728"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial","prostate","gastric","melanoma","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07072728","phase":"2","setting":"A Phase 2b Double-blind, Randomized, Low-dose Comparator-controlled Clinical Trial to Assess the Efficacy and Safety of NPX-5 in Psilocybin-assisted Psychotherapy for the Treatment of Adjustment Disorder Associated With Cancer.","sponsor":"Psyence Australia Pty Ltd","started":"2025-10-01","startedType":"actual","enrolled":87,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07052214","kind":"trial","name":"PSMA PET Combined With MRI for the Detection of PCa","aka":["BiPASS"],"tldr":"A phase 3 trial of Gallium-68 gozetotide in prostate cancer, run by Telix Pharmaceuticals (Innovations) Pty Limited, now recruiting.","summary":"PSMA PET Combined With MRI for the Detection of PCa is a phase 3 interventional study registered as NCT07052214 by Telix Pharmaceuticals (Innovations) Pty Limited, with 338 participants planned, started 2025-08-18 and due to reach its primary completion in 2027-01. Interventions recorded: 68Ga-PSMA-11. Conditions listed: PCA, Prostate Cancer, Prostatic Neoplasm, PSMA PET. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07052214","url":"https://clinicaltrials.gov/study/NCT07052214"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["psma-pet"],"targets":[],"drugs":["ga68-psma-11"],"companies":["telix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07052214","phase":"3","setting":"A Single Arm, Multicenter, Prospective, Open Label, Longitudinal Phase 3 Study of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) Combined With Magnetic Resonance Imaging (MRI) Compared to Standard of Care (SOC) for the Detection of Prostate Cancer (PCa).","sponsor":"Telix Pharmaceuticals (Innovations) Pty Limited","started":"2025-08-18","startedType":"actual","enrolled":338,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05381103","kind":"trial","name":"PSMA-PET to Guide Prostatectomy","aka":[],"tldr":"A phase 2/3 trial of an investigational treatment in prostate cancer, run by Five Eleven Pharma, Inc., now recruiting.","summary":"PSMA-PET to Guide Prostatectomy is a phase 2/3 interventional study registered as NCT05381103 by Five Eleven Pharma, Inc., with 288 participants planned, started 2021-10-01 and due to reach its primary completion in 2028-06-01.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05381103","url":"https://clinicaltrials.gov/study/NCT05381103"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["pet"],"targets":["psma"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05381103","phase":"2/3","setting":"PSMA-PET to Guide Prostatectomy: A Randomized Trial","sponsor":"Five Eleven Pharma, Inc.","started":"2021-10-01","startedType":"actual","enrolled":288,"enrolledBasis":"registry","outcomes":[]},{"id":"psma-prerp","kind":"trial","name":"PSMA-PreRP","aka":["68Ga-PSMA-11 PET before radical prostatectomy","16-001684"],"tldr":"The UCLA and UCSF scan study behind the first US approval of gallium PSMA PET: in men heading for prostate surgery it was very reliable when it called a pelvic lymph node positive, but it still missed about three in five of the nodes that pathology later found.","summary":"PSMA-PreRP is the US Illuccix label's name (Study 1) for the investigator-initiated, prospective, multicentre, single-arm, open-label phase 3 diagnostic-efficacy programme of 68Ga-PSMA-11 PET before planned radical prostatectomy at the University of California, San Francisco and the University of California, Los Angeles (Hope and colleagues, JAMA Oncology 2021; ClinicalTrials.gov NCT03368547, NCT02611882 and NCT02919111). From December 2015 to December 2019, men with intermediate- to high-risk prostate cancer had one PET scan with 3 to 7 mCi of 68Ga-PSMA-11. Each scan was read centrally by three blinded readers with a majority rule, and pelvic nodal findings were compared with histopathology after prostatectomy and pelvic lymph node dissection using nodal-region correlation.\n\nOf 764 men imaged, 277 (36 percent) went on to prostatectomy with lymph node dissection and formed the efficacy cohort; 75 of them (27 percent) had pelvic nodal metastasis on pathology. PET was positive for pelvic nodal, extrapelvic nodal and bone disease in 14, 1 and 3 percent. Per-patient sensitivity for pelvic nodal metastasis was 0.40 (95 percent CI 0.34 to 0.46), specificity 0.95 (0.92 to 0.97), positive predictive value 0.75 (0.70 to 0.80) and negative predictive value 0.81 (0.76 to 0.85). Of the 487 men who did not have surgery, most had radiotherapy (69 percent of those with follow-up) or systemic therapy (22 percent).\n\nThe authors state that the collaboration formed the foundation of the New Drug Application for 68Ga-PSMA-11, approved in December 2020. Telix's Illuccix kit (FDA December 2021) cites the programme as Study 1 (NCT03368547 and NCT02919111) and states that its efficacy for initial staging rests on that study of another gozetotide formulation; the label's own summary reports a 325-patient two-centre cut with 123 evaluable, which is a different analysis set from the paper's and is not used for the outcome rows here.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03368547","url":"https://clinicaltrials.gov/study/NCT03368547"},{"label":"ClinicalTrials.gov NCT02919111","url":"https://clinicaltrials.gov/study/NCT02919111"},{"label":"ClinicalTrials.gov NCT02611882","url":"https://clinicaltrials.gov/study/NCT02611882"},{"label":"JAMA Oncology 2021","url":"https://doi.org/10.1001/jamaoncol.2021.3771"},{"label":"Illuccix label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d4643b31-9b4f-673f-e053-2a95a90a559d"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":["psma-pet","pet-ct"],"targets":["psma"],"drugs":["illuccix","ga68-psma-11"],"companies":[],"institutions":["ucla-jonsson","ucsf"],"pathways":[],"terms":["sensitivity-specificity","ppv"],"trials":[],"people":["thomas-hope"],"bottlenecks":[],"keyPapers":["paper-psma-prerp-hope-jama-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03368547","phase":"3","setting":"Intermediate- to high-risk prostate cancer considered for radical prostatectomy: a single 68Ga-PSMA-11 PET scan for pelvic nodal staging, read against histopathology after prostatectomy and pelvic lymph node dissection","sponsor":"UCLA Jonsson Comprehensive Cancer Center and UCSF (investigator initiated)","result":"Per-patient sensitivity 0.40 (95% CI 0.34 to 0.46) and specificity 0.95 (0.92 to 0.97) for pelvic nodal metastasis against histopathology in the 277-man surgery cohort; positive predictive value 0.75, negative predictive value 0.81.","started":"2016-12-12","startedType":"actual","yearReported":2021,"enrolled":764,"enrolledBasis":"registered","enrolledNote":"The JAMA Oncology 2021 report covers 764 men imaged under three registrations (NCT03368547, NCT02919111 and NCT02611882), of whom 277 had surgery and formed the efficacy cohort; ClinicalTrials.gov NCT03368547 alone lists an actual enrolment of 400.","outcomes":[{"endpoint":"Sensitivity for pelvic nodal metastasis (per patient, nodal-region correlation, versus histopathology)","primary":true,"unit":"%","arms":[{"name":"68Ga-PSMA-11 PET","n":277,"value":40,"note":"Reported as 0.40; 95% CI 0.34 to 0.46; 75 of 277 men had nodal metastasis on pathology"}],"source":"https://doi.org/10.1001/jamaoncol.2021.3771"},{"endpoint":"Specificity for pelvic nodal metastasis (per patient, nodal-region correlation, versus histopathology)","primary":true,"unit":"%","arms":[{"name":"68Ga-PSMA-11 PET","n":277,"value":95,"note":"Reported as 0.95; 95% CI 0.92 to 0.97"}],"source":"https://doi.org/10.1001/jamaoncol.2021.3771"},{"endpoint":"Positive predictive value for pelvic nodal metastasis","unit":"%","arms":[{"name":"68Ga-PSMA-11 PET","n":277,"value":75,"note":"Reported as 0.75; 95% CI 0.70 to 0.80"}],"source":"https://doi.org/10.1001/jamaoncol.2021.3771"},{"endpoint":"Negative predictive value for pelvic nodal metastasis","unit":"%","arms":[{"name":"68Ga-PSMA-11 PET","n":277,"value":81,"note":"Reported as 0.81; 95% CI 0.76 to 0.85"}],"source":"https://doi.org/10.1001/jamaoncol.2021.3771"}],"replication":"proPSMA (Hofman, Lancet 2020; recorded as propsma) randomised PSMA PET/CT against conventional imaging for staging high-risk disease in Australia and found higher accuracy; OSPREY and CONDOR did the same job for the fluorine-18 tracer piflufolastat (Pylarify)."},{"id":"psmaddition","kind":"trial","name":"PSMAddition","aka":[],"tldr":"PSMAddition moved the radioligand Pluvicto into the first treatment of metastatic hormone-sensitive prostate cancer, given alongside hormone therapy, and the FDA approved this use on 31 July 2026. It delayed progression on scans, but severe side effects were more common and whether it lengthens life is not yet known.","summary":"PSMAddition, trial NCT04720157 sponsored by Novartis and reported in 2025, moved Pluvicto, or 177Lu-PSMA-617, into the first-line treatment of metastatic prostate cancer, and the FDA approved this use on 31 July 2026. It randomised 1,144 men with PSMA-positive metastatic hormone-sensitive disease to the radioligand plus androgen deprivation and an androgen receptor pathway inhibitor or to standard care alone, and met its primary radiographic progression-free survival endpoint at the second interim analysis, data cut-off 13 January 2025, with a hazard ratio of 0.72 and the median not reached in either arm, while overall survival was not reported and severe adverse events were more common. OnCo links it to radioligand therapy, the CRPC term and the idea of alpha-emitting PSMA therapy at first diagnosis. Whether early radioligand use improves survival or only delays progression is the open question.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT04720157","url":"https://clinicaltrials.gov/study/NCT04720157"},{"label":"FDA approval 31 Jul 2026","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-vipivotide-tetraxetan-androgen-receptor-pathway-inhibitor-therapy"},{"label":"Annals of Oncology LBA6 (ESMO 2025)","url":"https://www.annalsofoncology.org/article/S0923-7534(25)04871-9/fulltext"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["radioligand-therapy"],"targets":[],"drugs":["pluvicto"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":["castration-resistance"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-psmaddition-lancet-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04720157","phase":"3","setting":"PSMA-positive metastatic hormone-sensitive prostate cancer: 177Lu-PSMA-617 + ADT + ARPI vs ADT + ARPI","sponsor":"Novartis","result":"rPFS HR 0.72 (95% CI 0.58 to 0.90, p=0.0021), medians not reached in either arm at the second interim analysis; overall survival not yet reported.","started":"2021-06-09","startedType":"actual","yearReported":2025,"enrolled":1144,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic progression-free survival","primary":true,"unit":"months","arms":[{"name":"177Lu-PSMA-617 + standard care (ARPI + ADT)","note":"Updated HR 0.67; OS HR 0.80, immature"},{"name":"Standard care"}],"hr":0.72,"ci":[0.58,0.89],"p":"0.0016","source":"https://clinicaltrials.gov/study/NCT04720157"}],"replication":"Extends VISION and PSMAfore into hormone-sensitive disease; supported the July 2026 label expansion."},{"id":"psmafore","kind":"trial","name":"PSMAfore","aka":[],"tldr":"PSMAfore moved Pluvicto before chemotherapy in prostate cancer.","summary":"PSMAfore, trial NCT04689828 sponsored by Novartis and published in the Lancet in 2024, moved Pluvicto, or 177Lu-PSMA-617, before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer after one androgen receptor pathway inhibitor. It randomised 468 taxane-naive men to the radioligand or a switch of androgen receptor pathway inhibitor, met its primary radiographic progression-free survival endpoint with a large effect, and overall survival was confounded by crossover of most control patients, with crossover-adjusted analyses favouring the radioligand; approval in the pre-chemotherapy setting followed in 2025. Whether earlier use improves survival, not just progression, is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT04689828","url":"https://clinicaltrials.gov/study/NCT04689828"},{"label":"NICE TA930: lutetium-177 vipivotide tetraxetan for treating PSMA-positive hormone-relapsed metastatic prostate cancer after 2 or more treatments, not recommended","url":"https://www.nice.org.uk/guidance/ta930"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["radioligand-therapy"],"targets":[],"drugs":["pluvicto"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":["prostate-crpc-sequencing"],"trials":["card","vision","therap"],"people":["oliver-sartor","michael-morris"],"bottlenecks":[],"keyPapers":["paper-psmafore-lancet-2024"],"journals":[],"dependsOn":[],"notes":["PSMAfore moved lutetium-177 PSMA-617 in front of chemotherapy, against a switch of androgen receptor pathway inhibitor. The comparator is the weak point of the design, because CARD had already shown that switching from one androgen receptor pathway inhibitor to the other after rapid failure is much worse than moving to cabazitaxel. There is no NICE recommendation covering the pre-taxane setting in England; NICE TA930, which covers use after taxane chemotherapy and an anti-androgen, does not recommend the drug."],"nct":"NCT04689828","phase":"3","setting":"PSMA+ mCRPC after one ARPI, taxane-naive: 177Lu-PSMA-617 vs ARPI switch","sponsor":"Novartis","result":"rPFS HR 0.41.","started":"2021-06-15","startedType":"actual","yearReported":2023,"enrolled":469,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic progression-free survival","primary":true,"unit":"months","arms":[{"name":"177Lu-PSMA-617","n":234,"value":12},{"name":"ARPI switch","n":234,"value":5.6}],"hr":0.41,"ci":[0.29,0.56],"p":"<0.0001","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01653-2/fulltext"},{"endpoint":"Overall survival (crossover-adjusted)","unit":"months","arms":[{"name":"177Lu-PSMA-617","note":"Unadjusted OS HR 0.98 with 84% crossover from control"},{"name":"ARPI switch"}],"hr":0.59,"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01653-2/fulltext"}],"replication":"Confirms VISION in the pre-chemotherapy line; SPLASH (177Lu-PSMA-I&T) showed a smaller rPFS effect and no OS benefit, so agent and setting details matter."},{"id":"pt-1","kind":"trial","name":"PT-1 (Primary Thrombocythaemia 1)","aka":[],"tldr":"PT-1 is the trial that made hydroxyurea the first-line drug in high-risk ET: anagrelide gave more arterial clots, more serious bleeding and more progression to myelofibrosis.","summary":"PT-1 randomised 809 patients with high-risk essential thrombocythaemia to hydroxyurea or anagrelide, both with low-dose aspirin. After a median of 39 months the composite primary endpoint of arterial or venous thrombosis, serious haemorrhage or death from a thrombotic or haemorrhagic cause was more frequent on anagrelide (odds ratio 1.57); anagrelide gave more arterial clots, serious bleeding and transformation to myelofibrosis, and fewer venous clots (Harrison and colleagues, New England Journal of Medicine 2005). Registered as ISRCTN72251782.","status":"positive","asOf":"2026-09-16","links":[{"label":"ISRCTN72251782","url":"https://www.isrctn.com/ISRCTN72251782"},{"label":"NEJM 2005","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa043800"}],"tags":["essential-thrombocythaemia","mpn"],"related":[],"cancers":["essential-thrombocythaemia","myeloproliferative-neoplasms"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["hydroxyurea","anagrelide","inca033989","aspirin"],"companies":["mrc-ctu"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"High-risk essential thrombocythaemia: hydroxyurea plus aspirin versus anagrelide plus aspirin","sponsor":"Medical Research Council (UK)","result":"Composite of thrombosis, serious haemorrhage or vascular death more frequent with anagrelide (odds ratio 1.57); more arterial clots, bleeding and myelofibrosis on anagrelide.","yearReported":2005,"enrolled":809,"enrolledBasis":"registry","outcomes":[{"endpoint":"Arterial or venous thrombosis, serious haemorrhage, or death from thrombotic or haemorrhagic causes","primary":true,"arms":[{"name":"Anagrelide + low-dose aspirin","note":"Odds ratio 1.57 (95% CI 1.04-2.37) versus hydroxyurea; 809 patients, median follow-up 39 months"},{"name":"Hydroxyurea + low-dose aspirin"}],"p":"0.03","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa043800"}]},{"id":"ptld-1","kind":"trial","name":"PTLD-1","aka":["PTLD-1/3","PTLD-1 RSST","PTLD-1 risk-stratified sequential treatment"],"tldr":"PTLD-1 established how to treat lymphoma that arises after an organ transplant: start with the antibody rituximab alone, and use how well the patient responds to decide whether to continue rituximab or move to chemotherapy; seven in ten reached complete remission and patients lived a median of more than six years.","summary":"PTLD-1 was an international prospective phase 2 trial coordinated from Charite Berlin in adults with CD20-positive post-transplant lymphoproliferative disorder after solid organ transplantation that had not responded to reduced immunosuppression. The original protocol gave sequential rituximab then CHOP to all; the risk-stratified amendment (PTLD-1/3) gave four weekly rituximab infusions and then, in patients with a complete response, four further rituximab doses, while all others received four cycles of R-CHOP with G-CSF support. The primary endpoint was the overall response rate.\n\nAmong 126 patients in the risk-stratified analysis, 111 (88 percent) responded and 88 (70 percent) reached complete remission; the three-year response duration estimate was 82 percent and median overall survival 6.6 years, with grade 3 or 4 infections in 34 percent and treatment-related mortality of 8 percent. Response to rituximab induction remained prognostic despite stratification. The corpus's post-transplant lymphoproliferative disorder page describes rituximab consolidation alone for complete responders and R-CHOP for the rest on this evidence.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00590447","url":"https://clinicaltrials.gov/study/NCT00590447"}],"tags":["soc-trials"],"related":[],"cancers":["post-transplant-lymphoproliferative-disorder","non-hodgkin-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone","filgrastim"],"companies":[],"institutions":["charite"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-ptld-1-risk-stratified-sequential-treatment-trappe-jco-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00590447","phase":"2","setting":"CD20-positive post-transplant lymphoproliferative disorder after solid organ transplantation, unresponsive to reduction of immunosuppression: four weekly doses of rituximab, then consolidation chosen by response, four further rituximab doses for patients in complete remission and four cycles of R-CHOP for everyone else (risk-stratified sequential treatment)","sponsor":"Charite University, Berlin, Germany","result":"Overall response 88 percent and complete remission 70 percent with risk-stratified sequential treatment; three-year response duration 82 percent; median overall survival 6.6 years; treatment-related mortality 8 percent.","started":"2006-12","yearReported":2017,"enrolled":152,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate (complete or partial response after risk-stratified sequential treatment)","primary":true,"unit":"%","arms":[{"name":"Rituximab induction then rituximab or R-CHOP consolidation by response","n":126,"value":88,"note":"95% CI 81 to 93"}],"source":"https://doi.org/10.1200/JCO.2016.69.3564"},{"endpoint":"Complete response rate","unit":"%","arms":[{"name":"Rituximab induction then rituximab or R-CHOP consolidation by response","n":126,"value":70,"note":"95% CI 61 to 77"}],"source":"https://doi.org/10.1200/JCO.2016.69.3564"},{"endpoint":"Response duration at 3 years","unit":"%","arms":[{"name":"Rituximab induction then rituximab or R-CHOP consolidation by response","n":126,"value":82,"note":"95% CI 74 to 90"}],"source":"https://doi.org/10.1200/JCO.2016.69.3564"},{"endpoint":"Overall survival","unit":"years","arms":[{"name":"Rituximab induction then rituximab or R-CHOP consolidation by response","n":126,"value":6.6,"note":"Median; 95% CI 5.5 to 7.6 years"}],"source":"https://doi.org/10.1200/JCO.2016.69.3564"},{"endpoint":"Treatment-related mortality","unit":"%","arms":[{"name":"Rituximab induction then rituximab or R-CHOP consolidation by response","n":126,"value":8,"note":"95% CI 5 to 14; grade 3 or 4 infections 34 percent"}],"source":"https://doi.org/10.1200/JCO.2016.69.3564"}]},{"id":"nct06244992","kind":"trial","name":"PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of PTT-936 in advanced solid tumours, run by Pyrotech Therapeutics, Inc., now recruiting.","summary":"PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06244992 by Pyrotech Therapeutics, Inc., with 68 participants planned, started 2024-01-26 and due to reach its primary completion in 2027-09-30. Interventions recorded: PTT-936 and Combination of PTT-936 and anti-PD-1/L1 therapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06244992","url":"https://clinicaltrials.gov/study/NCT06244992"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["pd1"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06244992","phase":"1/2","setting":"A Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PTT-936, an Alpha Kinase 1 (ALPK1) Activator, Alone or in Combination With Anti-PD-1/L1 in Patients With Locally Advanced or Metastatic Solid Tumors","sponsor":"Pyrotech Therapeutics, Inc.","started":"2024-01-26","startedType":"actual","enrolled":68,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07586124","kind":"trial","name":"Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma","aka":[],"tldr":"A phase 2 trial of Pucotenlimab in head and neck squamous cell carcinoma, run by Lepu Biopharma Co., Ltd., now recruiting.","summary":"Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma is a phase 2 interventional study registered as NCT07586124 by Lepu Biopharma Co., Ltd., with 80 participants planned, started 2026-07-06 and due to reach its primary completion in 2027-12. Interventions recorded: Becotatug Vedotin for Injection, Placebo, Pucotenlimab Injection. Conditions listed: Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07586124","url":"https://clinicaltrials.gov/study/NCT07586124"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pucotenlimab"],"companies":["lepu-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07586124","phase":"2","setting":"A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of Pucotenlimab Injection Combined With Becotatug Vedotin for Injection as Perioperative Therapy in Participants With Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma","sponsor":"Lepu Biopharma Co., Ltd.","started":"2026-07-06","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06770270","kind":"trial","name":"Pucotenlimab Plus Radiotherapy and Chemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cance(PUCRT)","aka":["PUCRT"],"tldr":"A phase 2 trial of pucotenlimab in colorectal cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"Pucotenlimab Plus Radiotherapy and Chemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cance(PUCRT) is a phase 2, interventional study registered as NCT06770270 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 68 participants, started 2024-08-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: Pucotenlimab. Conditions listed: Rectal Cancer. Primary outcome: The rate of cCR; The rate of pCR. Colorectal eligibility wording from the registry: \"Histologically confirmed and evaluated as locally advanced rectal adenocarcinoma (confirmed by MRI): cT3 or higher; or cN+;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06770270","url":"https://clinicaltrials.gov/study/NCT06770270"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["pucotenlimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06770270","phase":"2","setting":"Pucotenlimab Combined With Radiotherapy and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Single-Arm Clinical Study(PUCRT)","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2024-08-01","startedType":"actual","enrolled":68,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06665100","kind":"trial","name":"PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)","aka":[],"tldr":"A phase 2 trial of PUL-042 in advanced solid tumours, run by Pulmotect, Inc., now recruiting.","summary":"PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV) is a phase 2 interventional study registered as NCT06665100 by Pulmotect, Inc., with 100 participants planned, started 2025-06-27 and due to reach its primary completion in 2027-04. Interventions recorded: PUL-042 and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06665100","url":"https://clinicaltrials.gov/study/NCT06665100"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06665100","phase":"2","setting":"Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients With Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) With Documented Viral Infections With PIV, hMPV or RSV","sponsor":"Pulmotect, Inc.","started":"2025-06-27","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03965234","kind":"trial","name":"Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases","aka":[],"tldr":"A phase 1/2 trial of cisplatin in colorectal cancer, run by Roswell Park Cancer Institute, now recruiting.","summary":"Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases is a phase 1/2, interventional study registered as NCT03965234 by Roswell Park Cancer Institute, with a registry enrolment figure of 99 participants, started 2020-07-16 and due to reach its primary completion in 2029-05-25. Interventions recorded: Cisplatin; Isolated Chemotherapeutic Lung Perfusion; Metastasectomy. Conditions listed: Metastatic Bone Sarcoma; Metastatic Malignant Neoplasm in the Lung; Metastatic Soft Tissue Sarcoma; Metastatic Unresectable Sarcoma; Resectable Sarcoma; Colorectal Cancer. Primary outcome: Incidence of local toxicities (Phase I); Recommended phase II dose (Phase I); Local recurrence (Phase II). Colorectal eligibility wording from the registry: \"* Colorectal carcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03965234","url":"https://clinicaltrials.gov/study/NCT03965234"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","mrd-testing","platinum"],"targets":[],"drugs":["cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03965234","phase":"1/2","setting":"Phase I/ II Study of Pulmonary Suffusion to Control Minimal Residual Disease in Resectable or Ablatable Sarcoma or Colorectal Pulmonary Metastases","sponsor":"Roswell Park Cancer Institute","started":"2020-07-16","startedType":"actual","enrolled":99,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06788171","kind":"trial","name":"PULSAR Combined With PD-1 Ab and Chemotherapy Plus Bev. for CRLM","aka":[],"tldr":"A phase 2 trial of bevacizumab (glioblastoma use), capecitabine, fOLFOX (5-FU, leucovorin, oxaliplatin) and sintilimab in colorectal cancer, run by Fujian Cancer Hospital, not yet recruiting.","summary":"PULSAR Combined With PD-1 Ab and Chemotherapy Plus Bev. for CRLM is a phase 2, interventional study registered as NCT06788171 by Fujian Cancer Hospital, with a registry enrolment figure of 35 participants, started 2025-03-01 and due to reach its primary completion in 2026-12-01. Interventions recorded: Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy; Bevacizumab; Capecitabine; Oxaliplatin; Sintilimab. Conditions listed: Colorectal Cancer Liver Metastasis. Primary outcome: Progression-free-Survival. Colorectal eligibility wording from the registry: \"Pathologically confirmed colorectal cancer with liver metastases (stage M1)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06788171","url":"https://clinicaltrials.gov/study/NCT06788171"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","sbrt"],"targets":[],"drugs":["bevacizumab-glioma","capecitabine","folfox","sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06788171","phase":"2","setting":"A Phase II Trial of PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) Combined With PD-1 Ab and Chemotherapy Plus Bevacizumab for Colorectal Cancer Liver Metastasis","sponsor":"Fujian Cancer Hospital","started":"2025-03-01","startedType":"estimated","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07269626","kind":"trial","name":"PULSAR in Systemic Therapy for Pancreatic Cancer","aka":["PULSAR"],"tldr":"A phase 2 trial in pancreatic cancer, run by Samsung Medical Center, now recruiting.","summary":"PULSAR in Systemic Therapy for Pancreatic Cancer is a phase 2, interventional study registered as NCT07269626 by Samsung Medical Center, with a registry enrolment figure of 47 participants, started 2025-11-14 and due to reach its primary completion in 2027-12-31. Interventions recorded: Personalized Ultrafractionated Adaptive Radiotherapy. Conditions listed: Locally Advanced Pancreatic Ductal Adenocarcinoma; Borderline Resectable Pancreatic Ductal Adenocarcinoma; Oligometastatic Pancreatic Ductal Adenocarcinoma. Primary outcome: progression-free survival at 1-year after enrollment; Progression-free survival; Local control (LC). Pancreatic eligibility wording from the registry: \"* Histologically confirmed pancreatic ductal adenocarcinoma\". Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07269626","url":"https://clinicaltrials.gov/study/NCT07269626"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac","locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07269626","phase":"2","setting":"A Prospective Phase II Study of Systemic Therapy With Combined Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy (PULSAR) in Pancreatic Cancer","sponsor":"Samsung Medical Center","started":"2025-11-14","startedType":"actual","enrolled":47,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06484829","kind":"trial","name":"Purinostat Mesylate Combined With Pomalidomide Capsules and Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 1/2 trial of Purinostat in multiple myeloma, run by Chengdu Zenitar Biomedical Technology Co., Ltd, now recruiting.","summary":"Purinostat Mesylate Combined With Pomalidomide Capsules and Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT06484829 by Chengdu Zenitar Biomedical Technology Co., Ltd, with 144 participants planned, started 2024-03-25 and due to reach its primary completion in 2026-02-01. Interventions recorded: Purinostat Mesylate 4 mg/m2, Purinostat Mesylate 6 mg/m2 and Purinostat Mesylate 8.4 mg/m2.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06484829","url":"https://clinicaltrials.gov/study/NCT06484829"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["purinostat"],"companies":["chengdu-zenitar-biomedical-technology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06484829","phase":"1/2","setting":"An Open-Label, Parallel-Controlled, Multi-Center Phase Ib/IIa Clinical Study to Evaluate the Efficacy and Safety of Purinostat Mesylate for Injection Combined With Pomalidomide Capsules and Low-Dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma","sponsor":"Chengdu Zenitar Biomedical Technology Co., Ltd","started":"2024-03-25","startedType":"actual","enrolled":144,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04683315","kind":"trial","name":"PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples","aka":["PANCREAS"],"tldr":"A phase 2 trial in pancreatic cancer, run by Medical College of Wisconsin, now recruiting.","summary":"PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples is a phase 2, interventional study registered as NCT04683315 by Medical College of Wisconsin, with a registry enrolment figure of 84 participants, started 2021-04-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: mFOLFIRINOX Treatment Regimen; Gemcitabine/Nab-paclitaxel Treatment Regimen. Conditions listed: Pancreatic Cancer. Primary outcome: Subjects who receive PurIST classification-directed therapy.. Pancreatic eligibility wording from the registry: \"Have suspicion of pancreas adenocarcinoma and plan for endoscopic biopsy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04683315","url":"https://clinicaltrials.gov/study/NCT04683315"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04683315","phase":"2","setting":"PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples","sponsor":"Medical College of Wisconsin","started":"2021-04-01","startedType":"actual","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01686594","kind":"trial","name":"PUVA Maintenance Therapy in Mycosis Fungoides","aka":[],"tldr":"A phase 3 trial of Methoxsalen in Cutaneous T-cell lymphoma and Peripheral T-cell lymphomas, run by Medical University of Graz, completed.","summary":"PUVA Maintenance Therapy in Mycosis Fungoides is a phase 3 interventional study registered as NCT01686594 by Medical University of Graz, with 28 participants recorded, started 2013-02 and reaching its primary completion in 2018-07-02. Interventions recorded: 8-methoxypsoralen. Conditions recorded: Patch/Plaque Stage Mycosis Fungoides.\n\nLinked to the drug Methoxsalen because the registry names it among its interventions and Cutaneous T-cell lymphoma and Peripheral T-cell lymphomas among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01686594","url":"https://clinicaltrials.gov/study/NCT01686594"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cutaneous-t-cell-lymphoma","peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["methoxsalen-ecp"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01686594","phase":"3","setting":"A Multi-center, Randomized Study on Oral 8-methoxypsoralen Plus UVA With or Without Maintenance Therapy in Mycosis Fungoides EORTC/ISCL Stage IA to IIB","sponsor":"Medical University of Graz","started":"2013-02","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07044336","kind":"trial","name":"Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)","aka":["Bluestar-Endometrial01"],"tldr":"A phase 3 trial of Puxitatug samrotecan, Doxorubicin, Paclitaxel / nab-paclitaxel in endometrial cancer, run by AstraZeneca, now recruiting.","summary":"Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) is a phase 3 interventional study registered as NCT07044336 by AstraZeneca, with 800 participants planned, started 2025-08-01 and due to reach its primary completion in 2027-10-15. Interventions recorded: Puxitatug Samrotecan, Doxorubicin, Paclitaxel. Conditions listed: Endometrial Cancer, Malignant Solid Tumour. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07044336","url":"https://clinicaltrials.gov/study/NCT07044336"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["puxitatug-samrotecan","doxorubicin","paclitaxel"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07044336","phase":"3","setting":"Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4 Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (Bluestar-Endometrial01)","sponsor":"AstraZeneca","started":"2025-08-01","startedType":"actual","enrolled":800,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04963595","kind":"trial","name":"Pyrotinib and Vinorelbine Tartrate Capsules With or Without Inetetamab for First Line Treatment in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer","aka":[],"tldr":"A phase 2 trial of Pyrotinib, Vinorelbine and Inetetamab in Breast cancer, run by Zhiyong Yu, with a status the registry has not verified recently.","summary":"Pyrotinib and Vinorelbine Tartrate Capsules With or Without Inetetamab for First Line Treatment in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer is a phase 2 interventional study registered as NCT04963595 by Zhiyong Yu, with 100 participants planned, started 2021-08-01 and due to reach its primary completion in 2023-01-31. Interventions recorded: Pyrotinib, Vinorelbine, Inetetamab. Conditions recorded: Metastatic Breast Cancer.\n\nLinked to the drug Inetetamab because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04963595","url":"https://clinicaltrials.gov/study/NCT04963595"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pyrotinib","vinorelbine","inetetamab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04963595","phase":"2","setting":"Phase II Study of Pyrotinib and Vinorelbine Tartrate Capsules With or Without Inetetamab for First Line Treatment in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer","sponsor":"Zhiyong Yu","started":"2021-08-01","startedType":"estimated","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06892925","kind":"trial","name":"QL1706 Combined With Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors","aka":["Spring"],"tldr":"A phase 2 trial of gemcitabine, oxaliplatin and lenvatinib in gallbladder cancer and other biliary tract cancers, run by Eastern Hepatobiliary Surgery Hospital, active and no longer recruiting.","summary":"QL1706 Combined With Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors is a phase 2 interventional study registered as NCT06892925 by Eastern Hepatobiliary Surgery Hospital, with a registry enrolment figure of 59 participants, started 2025-06-14 and due to reach its primary completion in 2026-12. Interventions recorded: QL1706. Conditions listed: Biliary Tract Tumors. Gallbladder cancer is named in the registry entry: \"3. The patient has a histologically confirmed diagnosis of unresectable locally advanced or metastatic biliary tract cancer, including cholangiocarcinoma (intrahepatic and extrahepatic) and gallbladder cancer.\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06892925","url":"https://clinicaltrials.gov/study/NCT06892925"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","kinase-inhibitors"],"targets":[],"drugs":["gemcitabine","oxaliplatin","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06892925","phase":"2","setting":"QL1706 Combined With Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors: A Single - Arm, Open - Label, Multi - Center, Prospective Phase II Clinical Trial (Spring Study)","sponsor":"Eastern Hepatobiliary Surgery Hospital","started":"2025-06-14","startedType":"actual","enrolled":59,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07649473","kind":"trial","name":"QL1706 Combined With Standard Therapy for Conversion Therapy of Synchronous Liver Metastases From Colon Cancer: a Multicenter, Single-arm, Exploratory Study","aka":[],"tldr":"A phase 2 trial of QL1706 in colorectal cancer, run by Fujian Medical University, not yet recruiting.","summary":"QL1706 Combined With Standard Therapy for Conversion Therapy of Synchronous Liver Metastases From Colon Cancer: a Multicenter, Single-arm, Exploratory Study is a phase 2, interventional study registered as NCT07649473 by Fujian Medical University, with a registry enrolment figure of 30 participants, started 2026-08-15 and due to reach its primary completion in 2028-12-31. Interventions recorded: QL1706 (Iparomlimab/Tuvonralimab). Conditions listed: Colon Cancer; Synchronous Liver Metastases. Primary outcome: Rate of R0 Resection and Complete Ablation. Colorectal eligibility wording from the registry: \"* Histologically or cytologically confirmed colon adenocarcinoma, with pathologically or radiographically verified liver-only metastases\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07649473","url":"https://clinicaltrials.gov/study/NCT07649473"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ql1706"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07649473","phase":"2","setting":"QL1706 Combined With Standard Therapy for Conversion Therapy of Synchronous Liver Metastases From Colon Cancer: a Multicenter, Single-arm, Exploratory Study","sponsor":"Fujian Medical University","started":"2026-08-15","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07025239","kind":"trial","name":"QL1706 Injection Plus Bevacizumab and XELOX vs Placebo Plus Bevacizumab and XELOX as First-Line Treatment of Unresectable Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 3 trial of QL1706, bevacizumab (glioblastoma use), fOLFOX (5-FU, leucovorin, oxaliplatin) and capecitabine in colorectal cancer, run by Qilu Pharmaceutical Co., Ltd., not yet recruiting.","summary":"QL1706 Injection Plus Bevacizumab and XELOX vs Placebo Plus Bevacizumab and XELOX as First-Line Treatment of Unresectable Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT07025239 by Qilu Pharmaceutical Co., Ltd., with a registry enrolment figure of 430 participants, started 2025-07 and due to reach its primary completion in 2028-07. Interventions recorded: QL1706; Bevacizumab; Oxaliplatin; Capecitabine; Placebo. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Progression Free Survival (PFS) Assessed by the Independent Radiology Review Committee (IRRC). Colorectal eligibility wording from the registry: \"* Unresectable metastatic colorectal adenocarcinoma confirmed by histopathology examination;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07025239","url":"https://clinicaltrials.gov/study/NCT07025239"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["ql1706","bevacizumab-glioma","folfox","capecitabine"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07025239","phase":"3","setting":"A Randomized, Double-blind, Multicenter Phase 3 Study of QL1706 Injection in Combination With Bevacizumab and XELOX Versus Placebo in Combination With Bevacizumab and XELOX as First-line Therapy for the Treatment of Patients With Unresectable Metastatic Colorectal Cancer (mCRC)","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2025-07","startedType":"estimated","enrolled":430,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07636226","kind":"trial","name":"QL1706 Plus Anlotinib as a Later-line Treatment for Patients With Advanced Lung Cancer","aka":[],"tldr":"A phase 2/3 trial of iparomlimab and tuvonralimab and anlotinib in lung cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"QL1706 Plus Anlotinib as a Later-line Treatment for Patients With Advanced Lung Cancer is a phase 2/3, randomised interventional study registered as NCT07636226 by Sun Yat-sen University, with a registry enrolment figure of 120 participants, started 2026-07-30 and due to reach its primary completion in 2028-12-30. Interventions recorded: QL1706; Anlotinib. Conditions listed: Small Cell Lung Cancer. Primary outcome: OS. Lung eligibility wording from the registry: \"Small cell lung cancer or lung squamous cell carcinoma confirmed by tissue or pathological examination\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07636226","url":"https://clinicaltrials.gov/study/NCT07636226"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["iparomlimab-tuvonralimab","anlotinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07636226","phase":"2/3","setting":"A Multicenter, Open-label, Randomized Controlled Phase II/III Study Evaluating the Efficacy and Safety of QL1706 in Combination With Anlotinib as a Later-line Treatment for Patients With Advanced Lung Cancer","sponsor":"Sun Yat-sen University","started":"2026-07-30","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07009145","kind":"trial","name":"QL1706 Plus Bevacizumab for Unresectable or Metastatic MSI-H/dMMR CRC","aka":[],"tldr":"A phase 2 trial of QL1706 and bevacizumab (glioblastoma use) in colorectal cancer, run by Qianfoshan Hospital, not yet recruiting.","summary":"QL1706 Plus Bevacizumab for Unresectable or Metastatic MSI-H/dMMR CRC is a phase 2, interventional study registered as NCT07009145 by Qianfoshan Hospital, with a registry enrolment figure of 22 participants, started 2025-06-27 and due to reach its primary completion in 2026-06-30. Interventions recorded: QL1706; Bevacizumab. Conditions listed: Unresectable Colorectal Cancer; Metastatic Colorectal Cancer (CRC); MSI-H/dMMR Colorectal Cancer. Primary outcome: ORR. Colorectal eligibility wording from the registry: \"* Histologically confirmed unresectable locally advanced or metastatic colorectal cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07009145","url":"https://clinicaltrials.gov/study/NCT07009145"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["ql1706","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07009145","phase":"2","setting":"An Exploratory Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Bevacizumab for the Treatment of Unresectable or Metastatic MSI-H/dMMR Colorectal Cancer","sponsor":"Qianfoshan Hospital","started":"2025-06-27","startedType":"estimated","enrolled":22,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06786026","kind":"trial","name":"QL1706 Plus Chemotherapy +/- Bevacizumab in 1L Treatment of R/mTNBC","aka":[],"tldr":"A phase 2 trial of bevacizumab, iparomlimab and tuvonralimab and nab-paclitaxel in triple-negative breast cancer, run by Fudan University, now recruiting.","summary":"QL1706 Plus Chemotherapy +/- Bevacizumab in 1L Treatment of R/mTNBC is a phase 2, interventional study registered as NCT06786026 by Fudan University, with a registry enrolment figure of 60 participants, started 2024-10-09 and due to reach its primary completion in 2025-09-30. Interventions recorded: bevacizumab; QL1706; Nab paclitaxel. Conditions listed: TNBC, Triple Negative Breast Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06786026","url":"https://clinicaltrials.gov/study/NCT06786026"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["bevacizumab","iparomlimab-tuvonralimab","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06786026","phase":"2","setting":"QL1706 Plus Nab-paclitaxel +/- Bevacizumab As 1L Treatment in Recurrent or Metastatic Triple-Negative Breast Cancer: a Non-randomized, Multicenter Phase II Study","sponsor":"Fudan University","started":"2024-10-09","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06404736","kind":"trial","name":"QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer","aka":["QUEEN-Dream"],"tldr":"A phase 2 trial of nab-paclitaxel and carboplatin in triple-negative breast cancer, run by Fudan University, not yet recruiting.","summary":"QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer is a phase 2, interventional study registered as NCT06404736 by Fudan University, with a registry enrolment figure of 73 participants, started 2024-05-07 and due to reach its primary completion in 2025-11-07. Interventions recorded: Bispecific antibody (bsAb) targeting PD-1 and CLTA-4; Albumin-bound paclitaxel; Carboplatin. Conditions listed: Early Breast Cancer; Neoadjuvant Therapy; TNBC, Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"According to the definition of the latest ASCO/CAP guidelines, histopathologically confirmed TNBC breast cancer, histological grade II, TNM stage T1cN1-cN2 or T2-T4, cN0-cN2;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06404736","url":"https://clinicaltrials.gov/study/NCT06404736"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["nab-paclitaxel","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06404736","phase":"2","setting":"A Phase II Study of Neoadjuvant QL1706 Plus Chemotherapy in Participants With High-Risk TNBC Early-Stage Breast Cancer (QUEEN-Dream)","sponsor":"Fudan University","started":"2024-05-07","startedType":"estimated","enrolled":73,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07342283","kind":"trial","name":"QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Affiliated Hospital of Nantong University, now recruiting.","summary":"QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer is a phase 2, interventional study registered as NCT07342283 by Affiliated Hospital of Nantong University, with a registry enrolment figure of 30 participants, started 2026-02-25 and due to reach its primary completion in 2027-12-25. Interventions recorded: Immunotherapy combined with chemotherapy. Conditions listed: Triple Negative Breast Cancer (TNBC). Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07342283","url":"https://clinicaltrials.gov/study/NCT07342283"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07342283","phase":"2","setting":"QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer","sponsor":"Affiliated Hospital of Nantong University","started":"2026-02-25","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06750861","kind":"trial","name":"QL1706 Plus Chemotherapy With AG Regime as First-line Treatment of Advanced PDAC","aka":[],"tldr":"A phase 2 trial of iparomlimab and tuvonralimab in pancreatic cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, not yet recruiting.","summary":"QL1706 Plus Chemotherapy With AG Regime as First-line Treatment of Advanced PDAC is a phase 2, interventional study registered as NCT06750861 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 30 participants, started 2025-02-15 and due to reach its primary completion in 2026-06-30. Interventions recorded: QL1706. Conditions listed: Pancreatic Adenocarcinoma. Primary outcome: Objective Response Rate (ORR); Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. Pancreatic eligibility wording from the registry: \"Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06750861","url":"https://clinicaltrials.gov/study/NCT06750861"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["iparomlimab-tuvonralimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06750861","phase":"2","setting":"QL1706 in Combination With Nab-paclitaxel and Gemcitabine as First-line Treatment in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2025-02-15","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06951997","kind":"trial","name":"QL1706 Plus Chidamide, AG as First-line Treatment for Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of iparomlimab and tuvonralimab, tucidinostat (chidamide), gemcitabine and nab-paclitaxel in pancreatic cancer, run by Tianjin Medical University Cancer Institute and Hospital, now recruiting.","summary":"QL1706 Plus Chidamide, AG as First-line Treatment for Metastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT06951997 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 33 participants, started 2025-03-07 and due to reach its primary completion in 2027-05-15. Interventions recorded: QL1706; Chidamide; Gemcitabine; Nab-paclitaxel. Conditions listed: Metastatic Pancreatic Cancer. Primary outcome: ORR. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed diagnosis of pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records showing metastatic pancreatic cancer (stage IV according to the AJCC 8th edition TNM staging of pancreatic cancer)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06951997","url":"https://clinicaltrials.gov/study/NCT06951997"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["iparomlimab-tuvonralimab","tucidinostat","gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06951997","phase":"2","setting":"Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chidamide, Albumin-bound Paclitaxel and Gemcitabine as First-line Treatment for Metastatic Pancreatic Cancer","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2025-03-07","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07156682","kind":"trial","name":"QL1706 Plus XELOX as Neoadjuvant Therapy for MSS/pMMR Clinical Stage III Colon Cancer","aka":[],"tldr":"A phase 2 trial of QL1706 and cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Qilu Hospital of Shandong University, not yet recruiting.","summary":"QL1706 Plus XELOX as Neoadjuvant Therapy for MSS/pMMR Clinical Stage III Colon Cancer is a phase 2, interventional study registered as NCT07156682 by Qilu Hospital of Shandong University, with a registry enrolment figure of 21 participants, started 2025-09-25 and due to reach its primary completion in 2027-06-30. Interventions recorded: QL1706; XELOX. Conditions listed: Colon Cancer; MSS/pMMR; QL1706. Primary outcome: Pathological Complete Response (pCR). Colorectal eligibility wording from the registry: \"* Histologically or clinically confirmed initially resectable Stage III colon cancer according to the AJCC 8th edition\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07156682","url":"https://clinicaltrials.gov/study/NCT07156682"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["ql1706","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07156682","phase":"2","setting":"A Single-Arm, Exploratory Study of Iparomlimab and Tuvonralimab (QL1706) Plus XELOX as Neoadjuvant Therapy in Patients With Microsatellite Stable (pMMR/MSS) Resectable Stage III Colon Cancer","sponsor":"Qilu Hospital of Shandong University","started":"2025-09-25","startedType":"estimated","enrolled":21,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07175636","kind":"trial","name":"QL1706 With Short-Course Radiotherapy and Chemotherapy for MSS Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"QL1706 With Short-Course Radiotherapy and Chemotherapy for MSS Rectal Cancer is a phase 2, interventional study registered as NCT07175636 by Sun Yat-sen University, with a registry enrolment figure of 66 participants, started 2025-09-20 and due to reach its primary completion in 2026-09-20. Interventions recorded: Drug: QL1706 Drug: mFOLFOX6 Radiation: Short-Course Radiotherapy (SCRT). Conditions listed: Locally Advanced Rectal Cancer (LARC); Mismatch Repair-Proficient (pMMR) Rectal Cancer; Non-metastatic Rectal Cancer. Primary outcome: Pathologic Complete Response (pCR) Rate. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07175636","url":"https://clinicaltrials.gov/study/NCT07175636"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07175636","phase":"2","setting":"A Multicenter, Prospective, Phase II Clinical Trial of Short-Course Radiotherapy Followed by QL1706 Plus mFOLFOX6 as Total Neoadjuvant Therapy for Patients With pMMR/MSS Locally Advanced Rectal Cancer","sponsor":"Sun Yat-sen University","started":"2025-09-20","startedType":"estimated","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07733115","kind":"trial","name":"QL1706（Iparomlimab/Tuvonralimab) Combined With Gemcitabine and Cisplatin as First-Line Treatment for PD-L1-Positive Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by Shanghai Zhongshan Hospital, now recruiting.","summary":"QL1706（Iparomlimab/Tuvonralimab) Combined With Gemcitabine and Cisplatin as First-Line Treatment for PD-L1-Positive Biliary Tract Cancer is a phase 2 interventional study registered as NCT07733115 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 38 participants, started 2026-07-20 and due to reach its primary completion in 2028-06-01. Interventions recorded: Iparomlimab and Tuvonralimab (QL1706), Gemcitabine and Cisplatin Chemotherapy. Conditions listed: Biliary Tract Cancer (BTC). Gallbladder cancer is named in the registry entry: \"3. Histologically confirmed unresectable or metastatic advanced biliary tract adenocarcinoma, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07733115","url":"https://clinicaltrials.gov/study/NCT07733115"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07733115","phase":"2","setting":"A Multicenter, Single-Arm, Phase II Clinical Study of QL1706 in Combination With Gemcitabine and Cisplatin (GC) as First-Line Treatment for PD-L1-Positive Biliary Tract Cancer","sponsor":"Shanghai Zhongshan Hospital","started":"2026-07-20","startedType":"estimated","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07110064","kind":"trial","name":"QL1706+Lenvatinib+AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of iparomlimab and tuvonralimab, lenvatinib and gemcitabine + nab-paclitaxel in pancreatic cancer, run by Du Juan, now recruiting.","summary":"QL1706+Lenvatinib+AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT07110064 by Du Juan, with a registry enrolment figure of 80 participants, started 2025-09-03 and due to reach its primary completion in 2027-08-31. Interventions recorded: QL1706+Lenvatinib+AG Regimen. Conditions listed: Advance Pancreatic Cancer. Primary outcome: Median Progression-Free Survival (mPFS). Pancreatic eligibility wording from the registry: \"Patients with histologically or cytologically confirmed advanced metastatic pancreatic cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07110064","url":"https://clinicaltrials.gov/study/NCT07110064"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["iparomlimab-tuvonralimab","lenvatinib","gemcitabine-nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07110064","phase":"2","setting":"Iparomlimab and Tuvonralimab Injection (QL1706) in Combination With Lenvatinib and AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer:A Prospective, Single-Arm, Multicenter, Phase II Clinical Study","sponsor":"Du Juan","started":"2025-09-03","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07463573","kind":"trial","name":"QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma","aka":[],"tldr":"A phase 3 trial testing QLC5508 in oesophageal cancer, now recruiting.","summary":"QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Oesophageal Squamous Cell Carcinoma is a phase 3 interventional study registered as NCT07463573, led by Qilu Pharmaceutical, and recruiting on the registry. Official title: A Randomised, Open-Label, Multicenter Phase III Study of QLC5508 Versus Investigator's Choice Chemotherapy in Pretreated Participants With Advanced or Metastatic Oesophageal Squamous Cell Carcinoma (ESCC). Planned enrolment is 466 participants (estimated). The study started in 2026-04-20 and primary completion is expected in 2028-06-05. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07463573","url":"https://clinicaltrials.gov/study/NCT07463573"}],"tags":["ctgov-ingest"],"related":[],"cancers":["esophageal","oesophageal-squamous-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["qlc5508"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07463573","phase":"3","setting":"A Randomized, Open-Label, Multicenter Phase III Study of QLC5508 Versus Investigator's Choice Chemotherapy in Pretreated Participants With Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)","sponsor":"Qilu Pharmaceutical","started":"2026-04-20","startedType":"actual","enrolled":466,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07509515","kind":"trial","name":"QLC5513 Alone or in Combination With QL1706 in Previously Treated Advanced or Metastatic TNBC.","aka":[],"tldr":"A phase 2 trial of iparomlimab and tuvonralimab in triple-negative breast cancer, run by Fudan University, not yet recruiting.","summary":"QLC5513 Alone or in Combination With QL1706 in Previously Treated Advanced or Metastatic TNBC. is a phase 2, randomised interventional study registered as NCT07509515 by Fudan University, with a registry enrolment figure of 60 participants, started 2026-04-15 and due to reach its primary completion in 2027-09-30. Interventions recorded: QLC5513; QLC5513+QL1706. Conditions listed: Triple-negative Breast Cancer (TNBC). Triple-negative eligibility wording from the registry: \"TNBC invasive breast cancer confirmed by histology (specific definition: ER \\<1% positive tumor cells by immunohistochemistry are defined as ER negative, PR \\<1% positive tumor cells are defined as PR negative, HER2 0-1+ or HER2 ++ but negative by FISH without amplification was defined as HER2 negat\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07509515","url":"https://clinicaltrials.gov/study/NCT07509515"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["iparomlimab-tuvonralimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07509515","phase":"2","setting":"An Open-label, Phase 2 Study of QLC5513 Alone or in Combination With Epalolimab Tovolimab (QL1706) in Previously Treated Advanced or Metastatic TNBC.","sponsor":"Fudan University","started":"2026-04-15","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07453394","kind":"trial","name":"QLS5132 Combination Therapy in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of bevacizumab, olaparib, iparomlimab and tuvonralimab, QL2107 and other drugs in lung cancer, run by Qilu Pharmaceutical Co., Ltd., not yet recruiting.","summary":"QLS5132 Combination Therapy in Advanced Solid Tumors is a phase 1/2, interventional study registered as NCT07453394 by Qilu Pharmaceutical Co., Ltd., with a registry enrolment figure of 626 participants, started 2026-04 and due to reach its primary completion in 2027-04. Interventions recorded: QLS5132; Bevacizumab; QLS5132; Platinum; Bevacizumab; QLS5132; Olaparib; Bevacizumab; QLS5132; QL1706; QL2107; QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin. Conditions listed: Gastric Cancer (GC); Non-small Cell Lung Cancer (NSCLC); Endometrial Cancer; Advanced Solid Tumors; Ovarian Cancer. Primary outcome: Incidence and severity of adverse events; Maximum tolerated dose (MTD); Recommended Phase 2 Dose (RP2D). No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07453394","url":"https://clinicaltrials.gov/study/NCT07453394"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","monoclonal-antibody","parp-inhibitor","platinum"],"targets":[],"drugs":["bevacizumab","olaparib","iparomlimab-tuvonralimab","ql2107","carboplatin","cisplatin","capox"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07453394","phase":"1/2","setting":"A Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenous QLS5132 Combination Therapy in Participants With Advanced Solid Tumors","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2026-04","startedType":"estimated","enrolled":626,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03828227","kind":"trial","name":"QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters.","aka":["COLAGE"],"tldr":"A phase 3 trial of capecitabine and bevacizumab (glioblastoma use) in colorectal cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group, active but no longer recruiting.","summary":"QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters. is a phase 3, randomised interventional study registered as NCT03828227 by GERCOR - Multidisciplinary Oncology Cooperative Group, with a registry enrolment figure of 49 participants, started 2019-06-14 and due to reach its primary completion in 2023-11-10. Interventions recorded: OPTIMOX-bevacizumab; Capecitabine plus bevacizumab. Conditions listed: Elderly Patients; Metastatic Colorectal Cancer; Quality of Life. Primary outcome: Health-related quality of life (HRQoL) at 6 months in the \"candidate group\".. Colorectal eligibility wording from the registry: \"Histologically proven colorectal adenocarcinoma,\". Sites: France. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03828227","url":"https://clinicaltrials.gov/study/NCT03828227"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine","bevacizumab-glioma"],"companies":["gercor"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03828227","phase":"3","setting":"Phase III Study to Evaluate the Quality of Life in Elderly Patients With Metastatic Colorectal Cancer Receiving First-line Therapy Based on Simplified Geriatric Parameters.","sponsor":"GERCOR - Multidisciplinary Oncology Cooperative Group","started":"2019-06-14","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"quantum-first","kind":"trial","name":"QuANTUM-First","aka":[],"tldr":"Roughly doubled median survival in the most aggressive FLT3 subtype by adding a selective FLT3 blocker to chemotherapy, including in patients over 60.","summary":"Median OS 31.9 vs 15.1 months (HR 0.776, 95% CI 0.615-0.979, p=0.032) at 39.2 months median follow-up; CR rates similar but relapse-free survival and MRD-negative remissions improved; benefit maintained when censored at transplant. Lancet 2023. Basis for the July 2023 US approval. Its inclusion of patients up to 75 extended the RATIFY concept to older adults.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02668653","url":"https://clinicaltrials.gov/study/NCT02668653"},{"label":"Lancet 2023","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00464-6/fulltext"}],"tags":[],"related":[],"cancers":["aml","aml-flt3"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["flt3"],"drugs":["quizartinib","cytarabine-7-3"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["richard-stone"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02668653","phase":"3","setting":"Newly diagnosed FLT3-ITD AML, age 18-75: quizartinib vs placebo with 7+3, consolidation, and up to 3 years of maintenance","sponsor":"Daiichi Sankyo","result":"OS 31.9 vs 15.1 months; HR 0.776.","started":"2016-09-01","startedType":"actual","yearReported":2022,"enrolled":539,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Quizartinib + 7+3","n":268,"value":31.9},{"name":"Placebo + 7+3","n":271,"value":15.1}],"hr":0.776,"ci":[0.615,0.979],"p":"0.032","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00464-6/fulltext"}],"replication":"Consistent with RATIFY (midostaurin); the FLT3-inhibitor-plus-7+3 effect has now been shown with two different molecules."},{"id":"nct05703971","kind":"trial","name":"Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients","aka":["Acclaim-3"],"tldr":"A phase 1/2 trial of Atezolizumab in small-cell lung cancer, run by Genprex, Inc., now recruiting.","summary":"Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients is a phase 1/2 interventional study registered as NCT05703971 by Genprex, Inc., with 62 participants planned, started 2024-05-09 and due to reach its primary completion in 2027-12. Interventions recorded: quaratusugene ozeplasmid, atezolizumab. Conditions listed: Small Cell Lung Cancer Extensive Stage. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05703971","url":"https://clinicaltrials.gov/study/NCT05703971"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab"],"companies":["genprex"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05703971","phase":"1/2","setting":"A Phase 1/2 Clinical Trial of Quaratusugene Ozeplasmid and Atezolizumab Maintenance Therapy in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)","sponsor":"Genprex, Inc.","started":"2024-05-09","startedType":"actual","enrolled":62,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04486833","kind":"trial","name":"Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib","aka":["Acclaim-1"],"tldr":"A phase 1/2 trial of Osimertinib in non-small-cell lung cancer, run by Genprex, Inc., now recruiting.","summary":"Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib is a phase 1/2 interventional study registered as NCT04486833 by Genprex, Inc., with 158 participants planned, started 2021-09-03 and due to reach its primary completion in 2028-03. Interventions recorded: quaratusugene ozeplasmid, osimertinib and Platinum-Based Chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04486833","url":"https://clinicaltrials.gov/study/NCT04486833"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":["genprex"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04486833","phase":"1/2","setting":"A Phase 1/2 Open-Label, Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination With Osimertinib in Patients With Advanced, Metastatic EGFR-Mutant, Metastatic Non-Small Cell Lung Cancer","sponsor":"Genprex, Inc.","started":"2021-09-03","startedType":"actual","enrolled":158,"enrolledBasis":"registry","outcomes":[]},{"id":"quartz","kind":"trial","name":"QUARTZ","aka":[],"tldr":"QUARTZ found that whole-brain radiotherapy added nothing measurable, in survival or quality of life, for lung cancer patients whose brain metastases could not be treated with surgery or radiosurgery.","summary":"QUARTZ randomised 538 patients with non-small-cell lung cancer and brain metastases unsuitable for resection or stereotactic radiosurgery to optimal supportive care with dexamethasone, with or without whole-brain radiotherapy (20 Gy in five fractions). Quality-adjusted life-years (46.4 vs 41.7 days) and overall survival (9.2 vs 8.5 weeks) did not differ meaningfully (Mulvenna and colleagues, Lancet 2016). The result restrained the routine use of whole-brain radiotherapy in patients with poor performance status.","status":"negative","asOf":"2026-09-16","links":[{"label":"ISRCTN3826061","url":"https://www.isrctn.com/ISRCTN3826061"},{"label":"Lancet 2016","url":"https://doi.org/10.1016/S0140-6736(16)30825-X"}],"tags":["radiation-wave2"],"related":[],"cancers":["nsclc","brain-tumours","secondary-brain-tumours"],"sections":[],"technologies":["palliative-radiotherapy","palliative-care"],"targets":[],"drugs":["dexamethasone"],"companies":["mrc-ctu"],"institutions":["uclh"],"pathways":[],"terms":["wbrt"],"trials":["big-lung-trial"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Non-small-cell lung cancer with brain metastases unsuitable for surgery or radiosurgery: whole-brain radiotherapy plus supportive care versus supportive care alone","sponsor":"Medical Research Council (UK)","result":"Quality-adjusted life-years 46.4 vs 41.7 days; overall survival 9.2 vs 8.5 weeks; no meaningful benefit from whole-brain radiotherapy.","yearReported":2016,"enrolled":538,"enrolledBasis":"registry","outcomes":[{"endpoint":"Quality-adjusted life-years","primary":true,"unit":"QALY days","arms":[{"name":"Optimal supportive care + WBRT","n":269,"value":46.4,"note":"Difference 4.7 days, two-sided 90% CI -12.7 to 3.3"},{"name":"Optimal supportive care alone","n":269,"value":41.7}],"source":"https://doi.org/10.1016/S0140-6736(16)30825-X"},{"endpoint":"Overall survival","arms":[{"name":"Optimal supportive care + WBRT"},{"name":"Optimal supportive care alone"}],"hr":1.06,"ci":[0.9,1.26],"source":"https://doi.org/10.1016/S0140-6736(16)30825-X"}]},{"id":"quasar","kind":"trial","name":"QUASAR","aka":["Quick and Simple and Reliable","ISRCTN82375386"],"tldr":"The UK trial that measured exactly how small the benefit of chemotherapy is after surgery for early bowel cancer, turning a default into a conversation.","summary":"QUASAR asked whether chemotherapy helps people whose bowel cancer was removed but whose risk of recurrence is low, the group for whom the answer had been guesswork. It randomised 3,239 people, nine in ten with stage II disease, to fluorouracil with folinic acid or to observation with chemotherapy held in reserve for recurrence. After a median 5.5 years the relative risk of death was 0.82 (95 percent confidence interval 0.70 to 0.95, p = 0.008) and of recurrence 0.78 (0.67 to 0.91, p = 0.001), with no significant difference by tumour site, stage, sex, age or schedule. The authors translated that into the number that mattered: assuming 20 percent five-year mortality without chemotherapy, an absolute survival gain of about 3.6 percent (1.0 to 6.0).","status":"positive","asOf":"2026-09-24","links":[{"label":"Lancet 2007","url":"https://europepmc.org/article/MED/18083404"},{"label":"ISRCTN82375386","url":"https://www.isrctn.com/ISRCTN82375386"}],"tags":["uk","adjuvant","colorectal"],"related":[],"cancers":["colorectal","colon-cancer"],"sections":["chemotherapy"],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","leucovorin"],"companies":["mrc-ctu"],"institutions":["oxford-cancer"],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":["dynamic","idea-collaboration"],"people":["rachel-kerr"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN82375386","phase":"3","setting":"Adjuvant fluorouracil and folinic acid against observation after apparently curative resection of colon or rectal cancer in people whose indication for chemotherapy was unclear; 2,963 of 3,239 (91 percent) had stage II, node-negative disease; 150 centres in 19 countries, enrolled May 1994 to December 2003","sponsor":"UK Coordinating Committee on Cancer Research and the Medical Research Council","result":"Relative risk of death 0.82 (0.70 to 0.95, p = 0.008) and of recurrence 0.78 (0.67 to 0.91, p = 0.001) with adjuvant fluorouracil and folinic acid; an absolute five-year survival gain of about 3.6 percent in stage II disease.","yearReported":2007,"enrolled":3239,"enrolledBasis":"randomised","enrolledNote":"3,239 patients were randomised in the Lancet 2007 report; the ISRCTN record does not print a separate target.","outcomes":[{"endpoint":"All-cause mortality","primary":true,"unit":"relative risk","arms":[{"name":"Fluorouracil and folinic acid","n":1622,"value":0.82,"note":"311 deaths"},{"name":"Observation","n":1617,"value":1,"note":"370 deaths"}],"ci":[0.7,0.95],"p":"0.008","source":"https://europepmc.org/article/MED/18083404"}]},{"id":"quazar-aml-001","kind":"trial","name":"QUAZAR AML-001","aka":["QUAZAR"],"tldr":"QUAZAR AML-001 showed that a tablet form of azacitidine taken as maintenance after chemotherapy helped older people with acute myeloid leukaemia live about ten months longer than placebo, and it became the first approved maintenance treatment for the disease.","summary":"QUAZAR AML-001 was a double-blind, placebo-controlled phase 3 trial in 472 patients aged 55 and over with acute myeloid leukaemia in first complete remission (with or without count recovery) after induction with or without consolidation, who were not candidates for stem-cell transplant. Patients were randomised to oral azacitidine 300 mg or placebo once daily for 14 days per 28-day cycle. The primary endpoint was overall survival.\n\nMedian overall survival was 24.7 months with oral azacitidine against 14.8 months with placebo, and relapse-free survival was also longer. Side effects were mainly gastrointestinal symptoms and neutropenia, and quality-of-life scores were maintained. Oral azacitidine (Onureg) was approved in the United States in September 2020 for continued treatment of adults with acute myeloid leukaemia in first remission who cannot complete intensive curative therapy.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01757535","url":"https://clinicaltrials.gov/study/NCT01757535"}],"tags":["soc-trials"],"related":[],"cancers":["aml","aml-older-unfit","leukaemia"],"sections":[],"technologies":["epigenetic-drugs"],"targets":[],"drugs":["azacitidine"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-quazar-aml-001-wei-nejm-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01757535","phase":"3","setting":"Acute myeloid leukaemia in first remission after intensive chemotherapy in patients aged 55 or older who were not going to transplant: oral azacitidine (CC-486) or placebo for 14 days of each 28-day cycle as maintenance","sponsor":"Celgene","result":"Median overall survival 24.7 months with oral azacitidine against 14.8 months with placebo (hazard ratio 0.69); approved in the United States in September 2020.","started":"2013-04-24","startedType":"actual","yearReported":2020,"enrolled":472,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Oral azacitidine + best supportive care","n":238,"value":24.7,"note":"95% CI 18.7 to 30.5; median follow-up 41.2 months"},{"name":"Placebo + best supportive care","n":234,"value":14.8,"note":"95% CI 11.7 to 17.6"}],"hr":0.69,"ci":[0.55,0.86],"p":"0.0009","source":"https://doi.org/10.1056/nejmoa2004444"},{"endpoint":"Relapse-free survival (registry, August 2024 cut-off)","unit":"months","arms":[{"name":"Oral azacitidine + best supportive care","value":10.2},{"name":"Placebo + best supportive care","value":4.8}],"hr":0.65,"ci":[0.52,0.8],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT01757535?tab=results"}]},{"id":"nct07601178","kind":"trial","name":"QUEEN-APPLE: A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Anlotinib Hydrochloride","aka":["QUEEN-APPLE"],"tldr":"A phase 2 trial of anlotinib and nab-paclitaxel in triple-negative breast cancer, run by Jiangsu Cancer Institute & Hospital, now recruiting.","summary":"QUEEN-APPLE: A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Anlotinib Hydrochloride and Nab-Paclitaxel as First-Line Treatment for Advanced Triple-Negative Breast Cancer is a phase 2, interventional study registered as NCT07601178 by Jiangsu Cancer Institute & Hospital, with a registry enrolment figure of 34 participants, started 2026-04-17 and due to reach its primary completion in 2027-09-15. Interventions recorded: TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ）. Conditions listed: TNBC, Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Confirmed by histopathological examination as advanced triple-negative invasive breast cancer, meeting the following criteria: pathological type triple-negative, specifically: ER negative (IHC \\<1%), PR negative (IHC \\<1%), HER2 negative (IHC -/+ or IHC ++ but FISH/CISH negative)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07601178","url":"https://clinicaltrials.gov/study/NCT07601178"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["anlotinib","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07601178","phase":"2","setting":"QUEEN-APPLE: A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Anlotinib Hydrochloride and Nab-Paclitaxel as First-Line Treatment for Advanced Triple-Negative Breast Cancer","sponsor":"Jiangsu Cancer Institute & Hospital","started":"2026-04-17","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"quilt-3-032","kind":"trial","name":"QUILT 3.032","aka":[],"tldr":"An IL-15 booster given with BCG produced complete responses in about 70% of patients with BCG-unresponsive carcinoma in situ and kept most bladders intact for years.","summary":"QUILT 3.032, trial NCT03022825 sponsored by ImmunityBio and reported in 2022, showed that the IL-15 superagonist nogapendekin alfa inbakicept, or N-803, given with BCG produced complete responses in about seventy percent of patients with BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ and kept most bladders intact for years. In the single-arm CIS cohort of 77 patients the complete response rate was 71 percent with a median duration around two years, and the company's five-year update reported bladder preservation in more than eighty percent of responders at three years, leading to FDA approval on 22 April 2024 after a 2023 complete response letter over manufacturing. Without a randomised comparison, how it ranks against cretostimogene and nadofaragene is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03022825","url":"https://clinicaltrials.gov/study/NCT03022825"}],"tags":[],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["nogapendekin-alfa","bcg-intravesical"],"companies":["immunitybio"],"institutions":[],"pathways":[],"terms":["bcg-unresponsive"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03022825","phase":"2/3","setting":"BCG-unresponsive NMIBC with CIS: nogapendekin alfa inbakicept (N-803) + BCG, single arm","sponsor":"ImmunityBio","result":"CR 71%.","started":"2017-06-02","startedType":"actual","yearReported":2022,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response rate (CIS)","primary":true,"unit":"%","arms":[{"name":"N-803 + BCG","n":77,"value":71}],"source":"https://doi.org/10.1056/EVIDoa2200167"}],"replication":"Single-arm; QUILT 2.005 (BCG-naive) and BCG-unresponsive papillary cohorts extend the evidence."},{"id":"nct03228667","kind":"trial","name":"QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors","aka":["QUILT-3"],"tldr":"A phase 2 trial of Nogapendekin alfa inbakicept, Pembrolizumab, Nivolumab in non-small-cell lung cancer and small-cell lung cancer, run by ImmunityBio, Inc., active and no longer recruiting.","summary":"QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors is a phase 2 interventional study registered as NCT03228667 by ImmunityBio, Inc., with 40 participants planned, started 2018-12-11 and due to reach its primary completion in 2029-08-31. Interventions recorded: N-803 + Pembrolizumab, N-803 + Nivolumab, N-803 + Atezolizumab, N-803 + Avelumab, N-803 + Durvalumab. Conditions listed: Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Urothelial Carcinoma, Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03228667","url":"https://clinicaltrials.gov/study/NCT03228667"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","head-and-neck","merkel-cell-carcinoma","melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["nogapendekin-alfa","pembrolizumab","nivolumab","atezolizumab","avelumab","durvalumab"],"companies":["immunitybio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03228667","phase":"2","setting":"QUILT-3.055: A Phase IIb, Multicohort, Open-Label Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With PD-1/PD-L1 Immune Checkpoint Inhibitors","sponsor":"ImmunityBio, Inc.","started":"2018-12-11","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"radar-hodgkin","kind":"trial","name":"RADAR","aka":["RADAR trial","A2VD in early-stage Hodgkin lymphoma","ISRCTN RADAR"],"tldr":"An international trial asking whether swapping one old chemotherapy drug for a targeted antibody lets most people with early Hodgkin lymphoma avoid radiotherapy altogether.","summary":"RADAR is two parallel trials sharing one analysis: trial 1 led by University College London across Europe, Australia and New Zealand, trial 2 led by the Canadian Cancer Trials Group across North America, with the datasets combined to reach the target of 1,042 participants.\n\nParticipants are randomised to ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) or A2VD, which replaces the bleomycin with brentuximab vedotin and adds growth factor support. Everyone has a centrally reviewed scan after two cycles. A Deauville score of 1 to 3 means one further cycle of the randomised chemotherapy and then follow-up with no radiotherapy at all. A Deauville score of 4 means two further cycles followed by involved-site radiotherapy. A Deauville score of 5 means coming off trial treatment. Follow-up runs for a minimum of five years, and primary completion is estimated for September 2030.\n\nThe design is a direct response to HD16 and EORTC H10, which both showed that an interim scan alone is not enough to justify dropping radiotherapy. RADAR changes the chemotherapy as well, on the hypothesis that a more active regimen will make the omission safe. The primary endpoint is progression-free survival. Sites are open in Australia, Belgium, Canada, Denmark, Ireland, the Netherlands, New Zealand, Portugal, Slovakia, Spain, the United Kingdom and the United States.","status":"active","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT04685616","url":"https://clinicaltrials.gov/study/NCT04685616"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["early-stage-classical-hodgkin-lymphoma","hodgkin-lymphoma"],"sections":["adcs","radiation","imaging"],"technologies":["adc","pet-ct","radiotherapy"],"targets":["cd30"],"drugs":["brentuximab-vedotin","doxorubicin","bleomycin","vinblastine","dacarbazine"],"companies":[],"institutions":["cruk"],"pathways":[],"terms":["deauville-score","abvd-beacopp"],"trials":["hd16","eortc-h10","echelon-1"],"people":[],"bottlenecks":["b-survivorship","b-toxicity-qol"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04685616","phase":"3","setting":"Untreated early-stage classical Hodgkin lymphoma: ABVD against A2VD, which replaces the bleomycin with brentuximab vedotin, with treatment after two cycles set by a centrally reviewed scan","sponsor":"University College London with the Canadian Cancer Trials Group","started":"2022-04-14","startedType":"actual","enrolled":1042,"enrolledBasis":"registry","outcomes":[]},{"id":"radcomp","kind":"trial","name":"RADCOMP","aka":[],"tldr":"A randomised trial of protons versus photons for non-metastatic breast cancer, asking whether protons spare the heart and lung when the breast and nodes need radiation.","summary":"RADCOMP (NCT02603341) randomises non-metastatic breast cancer to proton or photon radiotherapy, with major cardiovascular events as a long-horizon endpoint. The anatomy (left chest wall, internal mammary nodes, heart, lung) is where exit dose and a distal Bragg peak could matter. It tests integral dose and whether variable RBE at the chest-wall/heart interface helps or hurts. ClinicalTrials.gov listed the study as active, not recruiting, with primary completion estimated in 2036; no primary readout is in the corpus.","status":"active","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02603341","url":"https://clinicaltrials.gov/study/NCT02603341"}],"tags":["radiation-wave5"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["proton-therapy","imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["relative-biological-effectiveness","linear-energy-transfer","bragg-peak"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02603341","phase":"3","setting":"Non-metastatic breast cancer: proton versus photon radiotherapy","sponsor":"Abramson Cancer Center at Penn Medicine","started":"2016-04-06","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"radiant-3-4","kind":"trial","name":"RADIANT-3 and RADIANT-4","aka":[],"tldr":"The two trials that made everolimus a standard pill for pancreatic, lung and gut neuroendocrine tumours.","summary":"RADIANT-3 and RADIANT-4, led by trial NCT00510068 and sponsored by Novartis, are the two trials, reported from 2011, that made everolimus a standard tablet for pancreatic, lung and gastrointestinal neuroendocrine tumours. RADIANT-3 randomised 410 patients with progressive pancreatic neuroendocrine tumours and RADIANT-4 302 patients with lung or gastrointestinal tumours to everolimus or placebo, and both met their primary progression-free survival endpoints with large effects, while overall survival was not significantly improved because of crossover. OnCo links them to neuroendocrine tumours, everolimus and James C. Yao. Whether everolimus should come before or after radioligand therapy, which COMPETE has now tested directly, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00510068","url":"https://clinicaltrials.gov/study/NCT00510068"}],"tags":[],"related":[],"cancers":["neuroendocrine","pancreatic-net","small-intestinal-net","lung-net"],"sections":[],"technologies":["kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["everolimus"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["james-yao"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00510068","phase":"3","setting":"Progressive pancreatic NETs (RADIANT-3, n=410) and lung/GI NETs (RADIANT-4, n=302): everolimus vs placebo","sponsor":"Novartis","result":"PFS HR 0.35 (pNET) and 0.48 (lung/GI).","started":"2007-07","yearReported":2011,"enrolled":712,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (RADIANT-3)","primary":true,"unit":"months","arms":[{"name":"Everolimus","n":207,"value":11},{"name":"Placebo","n":203,"value":4.6}],"hr":0.35,"ci":[0.27,0.45],"source":"https://doi.org/10.1056/NEJMoa1009290"},{"endpoint":"Progression-free survival (RADIANT-4)","primary":true,"unit":"months","arms":[{"name":"Everolimus","n":205,"value":11},{"name":"Placebo","n":97,"value":3.9}],"hr":0.48,"ci":[0.35,0.67],"source":"https://doi.org/10.1016/S0140-6736(15)00817-X"}]},{"id":"nct06814496","kind":"trial","name":"Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors","aka":["RABBIT"],"tldr":"A phase 1/2 trial of tarlatamab in lung cancer, run by University of Arizona, now recruiting.","summary":"Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors is a phase 1/2, interventional study registered as NCT06814496 by University of Arizona, with a registry enrolment figure of 30 participants, started 2025-09-08 and due to reach its primary completion in 2030-05. Interventions recorded: Tarlatamab; Concurrent Radiation Therapy; Sequential Radiation therapy. Conditions listed: Melanoma; Medullary Thyroid Cancer; Sinonasal Undifferentiated Carcinoma; Esthesioneuroblastoma; Bladder Cancer; Testicular Cancer; Glioblastoma Multiforme; Cervical Cancer; Large Cell Neuroendocrine Carcinoma of the Lung; Non Small Cell Lung Cancer;. Primary outcome: Percentage of participants experiencing dose limiting toxicities (DLT) attributed to radiation or combination of radiation and tarlatamab.. Lung eligibility wording from the registry: \"SCLC\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06814496","url":"https://clinicaltrials.gov/study/NCT06814496"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["bispecific-antibody","imrt-igrt","t-cell-engager"],"targets":[],"drugs":["tarlatamab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06814496","phase":"1/2","setting":"RAdiation comBined With BIspecific T-Cell Engager in DLL3 Expressing Tumors (RABBIT) Study: A Phase I/II Study of AMG757 / Tarlatamab and Concurrent Radiation Therapy in Tumors With High Prevalence of DLL3","sponsor":"University of Arizona","started":"2025-09-08","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00936390","kind":"trial","name":"Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Bicalutamide, Flutamide, Goserelin / leuprolide, Buserelin, Triptorelin and Degarelix in Prostate cancer, run by Radiation Therapy Oncology Group, completed.","summary":"Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer is a phase 3 interventional study registered as NCT00936390 by Radiation Therapy Oncology Group, with 1538 participants recorded, started 2009-09 and reaching its primary completion in 2020-10-03. Interventions recorded: bicalutamide, flutamide, LHRH agonist (antagonist) therapy, Dose-Escalated Radiation Therapy. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Buserelin because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00936390","url":"https://clinicaltrials.gov/study/NCT00936390"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-intermediate-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["bicalutamide","flutamide","goserelin","buserelin","triptorelin","degarelix"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00936390","phase":"3","setting":"A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer","sponsor":"Radiation Therapy Oncology Group","started":"2009-09","startedType":"actual","yearReported":2022,"enrolled":1538,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants Alive (Overall Survival)","primary":true,"unit":"%","arms":[{"name":"Dose-Escalated Radiation Therapy Alone","n":750,"value":90,"note":"95% CI 87.7 to 92.2; Figures from the ClinicalTrials.gov results section (first posted 2022-10-06), not from a publication"},{"name":"Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation","n":742,"value":91,"note":"95% CI 88.8 to 93.1"}],"hr":0.85,"ci":[0.65,1.11],"p":"0.22","source":"https://clinicaltrials.gov/study/NCT00936390?tab=results"}]},{"id":"nct00769379","kind":"trial","name":"Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy","aka":[],"tldr":"A phase 3 trial of Trastuzumab and Trastuzumab biosimilars in Ductal carcinoma in situ, run by National Cancer Institute (NCI), completed.","summary":"Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy is a phase 3 interventional study registered as NCT00769379 by National Cancer Institute (NCI), with 2014 participants recorded, started 2008-12-10 and reaching its primary completion in 2019-12-31. Interventions recorded: Laboratory Biomarker Analysis, Trastuzumab, Whole Breast Irradiation. Conditions recorded: Breast Ductal Carcinoma In Situ.\n\nLinked to the drug Trastuzumab biosimilars because the registry names it among its interventions and Ductal carcinoma in situ among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00769379","url":"https://clinicaltrials.gov/study/NCT00769379"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ductal-carcinoma-in-situ"],"sections":[],"technologies":[],"targets":[],"drugs":["trastuzumab","trastuzumab-biosimilars"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00769379","phase":"3","setting":"A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently With Radiation Therapy and Radiation Therapy Alone for Women With HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy","sponsor":"National Cancer Institute (NCI)","started":"2008-12-10","startedType":"actual","yearReported":2022,"enrolled":2014,"enrolledBasis":"registry","outcomes":[{"endpoint":"Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence, or Ipsilateral DCIS-Free Survival","primary":true,"unit":"%","arms":[{"name":"Arm I (Standard WBI)","n":1005,"value":95.1,"note":"95% CI 93.8 to 96.5; Figures from the ClinicalTrials.gov results section (first posted 2022-02-23), not from a publication"},{"name":"Arm II (WBI, Trastuzumab)","n":993,"value":96.1,"note":"95% CI 94.9 to 97.3"}],"source":"https://clinicaltrials.gov/study/NCT00769379?tab=results"},{"endpoint":"Overall Survival","unit":"%","arms":[{"name":"Arm I (Standard WBI)","n":1005,"value":98.9,"note":"95% CI 98.2 to 99.5; Figures from the ClinicalTrials.gov results section (first posted 2022-02-23), not from a publication"},{"name":"Arm II (WBI, Trastuzumab)","n":993,"value":99,"note":"95% CI 98.3 to 99.6"}],"source":"https://clinicaltrials.gov/study/NCT00769379?tab=results"}]},{"id":"nct07808138","kind":"trial","name":"RADICAL-IO: thRee Cycles of immunotherApy Without raDical Therapy In mediCALly InOperable Stage I Non-small Cell Lung Cancer","aka":["RADICAL-IO"],"tldr":"A phase 2 trial in lung cancer, run by The Netherlands Cancer Institute, not yet recruiting.","summary":"RADICAL-IO: thRee Cycles of immunotherApy Without raDical Therapy In mediCALly InOperable Stage I Non-small Cell Lung Cancer is a phase 2, interventional study registered as NCT07808138 by The Netherlands Cancer Institute, with a registry enrolment figure of 30 participants, started 2026-11 and due to reach its primary completion in 2029-12-01. Interventions recorded: Cemiplimab 350 mg IV. Conditions listed: Non Small Cell Lung Cancer; Immunotherapy. Primary outcome: Recurrence free survival (RFS) as per RECIST 1.1. Lung eligibility wording from the registry: \"tumor diameter ≤ 3 cm) NSCLC according to the 9th AJCC/UICC staging classification (30)\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07808138","url":"https://clinicaltrials.gov/study/NCT07808138"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07808138","phase":"2","setting":"RADICAL-IO: thRee Cycles of immunotherApy Without raDical Therapy In mediCALly InOperable Stage I Non-small Cell Lung Cancer","sponsor":"The Netherlands Cancer Institute","started":"2026-11","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"radicals-hd","kind":"trial","name":"RADICALS-HD","aka":["RADICALS-HD","RADICALS hormone duration comparison"],"tldr":"Two years of hormone therapy alongside radiotherapy after prostate surgery kept the cancer from spreading in six more men in a hundred than six months did, at the cost of more side effects.","summary":"RADICALS-HD randomised 1,523 men, median age 65, at 138 centres in Canada, Denmark, Ireland and the United Kingdom to add 6 months of androgen deprivation (761) or 24 months (762) to postoperative radiotherapy. Androgen deprivation could be a monthly or 3-monthly gonadotrophin-releasing hormone analogue, daily oral bicalutamide 150 mg, or monthly subcutaneous degarelix. The comparison had over 80 percent power to detect an increase in 10-year metastasis-free survival from 75 to 81 percent.\n\nAt a median 8.9 years and 313 metastasis-free survival events, long-course treatment was better: 174 events on short-course against 139 on long-course, hazard ratio 0.773 (95 percent confidence interval 0.612 to 0.975, p=0.029). Ten-year metastasis-free survival was 71.9 percent (67.6 to 75.7) with 6 months and 78.1 percent (74.2 to 81.5) with 24 months.\n\nThe cost is stated plainly in the paper: grade 3 or higher toxicity in 105 of 753 men (14 percent) on short-course against 142 of 757 (19 percent) on long-course (p=0.025), with no treatment-related deaths. The authors framed the recommendation as conditional, for individuals who can accept the additional duration of adverse effects, which is the right way to put a 6 percentage point gain against eighteen extra months of castration.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00541047","url":"https://clinicaltrials.gov/study/NCT00541047"},{"label":"ISRCTN registry ISRCTN40814031","url":"https://www.isrctn.com/ISRCTN40814031"},{"label":"RADICALS-HD (Lancet 2024)","url":"https://doi.org/10.1016/S0140-6736(24)00549-X"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk","prostate-bcr"],"sections":[],"technologies":["androgen-deprivation","imrt-igrt"],"targets":[],"drugs":["bicalutamide","degarelix"],"companies":["mrc-ctu"],"institutions":["uclh"],"pathways":[],"terms":["adt","salvage-therapy","prostatectomy","hormone-therapy"],"trials":["radicals-rt","getug-afu-16","nct00567580"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN40814031","phase":"3","setting":"Postoperative radiotherapy after radical prostatectomy with a PSA below 5 and no metastatic disease: 6 months of androgen deprivation against 24 months, given as a gonadotrophin-releasing hormone analogue, bicalutamide 150 mg daily or degarelix, with metastasis-free survival as the primary outcome","sponsor":"MRC Clinical Trials Unit at UCL, funded by Cancer Research UK, UK Research and Innovation and the Canadian Cancer Society","result":"Ten-year metastasis-free survival 78.1 percent with 24 months of androgen deprivation against 71.9 percent with 6 months (hazard ratio 0.773, 95 percent confidence interval 0.612 to 0.975, p=0.029); grade 3 or higher toxicity 19 against 14 percent.","yearReported":2024,"enrolled":1523,"enrolledBasis":"randomised","enrolledNote":"1,523 men were randomised to the short-course against long-course hormone duration comparison at 138 centres; NCT00541047 also covers the separate RADICALS-RT timing randomisation, so the registry figure is larger.","outcomes":[{"endpoint":"Metastasis-free survival at 10 years","primary":true,"unit":"%","arms":[{"name":"Long-course androgen deprivation, 24 months","n":762,"value":78.1},{"name":"Short-course androgen deprivation, 6 months","n":761,"value":71.9}],"hr":0.773,"ci":[0.612,0.975],"p":"0.029","source":"https://doi.org/10.1016/S0140-6736(24)00549-X"},{"endpoint":"Grade 3 or higher toxicity","unit":"%","arms":[{"name":"Long-course androgen deprivation, 24 months","n":757,"value":19},{"name":"Short-course androgen deprivation, 6 months","n":753,"value":14}],"p":"0.025","source":"https://doi.org/10.1016/S0140-6736(24)00549-X"}],"replication":"Consistent in direction with GETUG-AFU 16, which showed that adding 6 months of goserelin to salvage radiotherapy improves progression-free survival, and with SPPORT, which added pelvic nodal radiotherapy on top."},{"id":"radicals-rt","kind":"trial","name":"RADICALS-RT","aka":["RADICALS-RT","RADICALS radiotherapy timing comparison"],"tldr":"Waiting to see whether the PSA rises after prostate surgery, and only then giving radiotherapy, works as well as treating everybody straight away, and spares two men in three the radiotherapy altogether.","summary":"RADICALS-RT randomised 1,396 men in trial-accredited centres in Canada, Denmark, Ireland and the United Kingdom, 697 to adjuvant radiotherapy and 699 to an observation policy with salvage radiotherapy for PSA biochemical progression. Median age was 65. The trial was powered on freedom from distant metastases, designed to detect a rise from 90 percent with salvage to 95 percent at 10 years.\n\nAt a median 4.9 years, 649 of 697 men allocated adjuvant radiotherapy (93 percent) had it within 6 months, while only 228 of 699 (33 percent) in the observation group had radiotherapy within 8 years. That single number is the practical result: two men in three were spared pelvic radiotherapy.\n\nWith 169 events, 5-year biochemical progression-free survival was 85 percent with adjuvant and 88 percent with salvage radiotherapy, hazard ratio 1.10 (95 percent confidence interval 0.81 to 1.49, p=0.56). Freedom from non-protocol hormone therapy at 5 years was 93 against 92 percent, hazard ratio 0.88 (0.58 to 1.33, p=0.53).\n\nThe harm was measurable and one-sided. Self-reported urinary incontinence was worse at 1 year after adjuvant radiotherapy (mean score 4.8 against 4.0, p=0.0023), and grade 3 to 4 urethral stricture within 2 years occurred in 6 percent against 4 percent (p=0.020). The conclusion, that an observation policy with salvage radiotherapy should be the standard, is now written into practice.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00541047","url":"https://clinicaltrials.gov/study/NCT00541047"},{"label":"ISRCTN registry ISRCTN40814031","url":"https://www.isrctn.com/ISRCTN40814031"},{"label":"RADICALS-RT (Lancet 2020)","url":"https://doi.org/10.1016/S0140-6736(20)31553-1"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk","prostate-bcr"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["mrc-ctu"],"institutions":["uclh"],"pathways":[],"terms":["prostatectomy","salvage-therapy","biochemical-recurrence","neoadjuvant-adjuvant","qol-pro"],"trials":["raves","getug-afu-17","artistic-meta-analysis","radicals-hd","swog-8794","eortc-22911"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00541047","phase":"3","setting":"Prostate cancer after radical prostatectomy with at least one risk factor, being pathological T3 or T4, Gleason 7 to 10, positive margins or preoperative PSA of 10 or more: adjuvant radiotherapy against an observation policy with salvage radiotherapy triggered by a PSA of 0.1 or more or three consecutive rises, with freedom from distant metastases as the primary outcome","sponsor":"MRC Clinical Trials Unit at UCL, funded by Cancer Research UK, the MRC and the Canadian Cancer Society","result":"Five-year biochemical progression-free survival 85 percent with adjuvant against 88 percent with early salvage radiotherapy (hazard ratio 1.10, 95 percent confidence interval 0.81 to 1.49); only 33 percent of the observation group needed radiotherapy within 8 years, and adjuvant treatment caused more incontinence and urethral stricture.","started":"2007-11","yearReported":2020,"enrolled":1396,"enrolledBasis":"randomised","enrolledNote":"1,396 men were randomised to the radiotherapy timing comparison; NCT00541047 also covers the separate RADICALS-HD hormone duration randomisation, so the registry figure is larger.","outcomes":[{"endpoint":"Biochemical progression-free survival at 5 years","unit":"%","arms":[{"name":"Adjuvant radiotherapy","n":697,"value":85},{"name":"Observation with salvage radiotherapy","n":699,"value":88}],"hr":1.1,"ci":[0.81,1.49],"p":"0.56","source":"https://doi.org/10.1016/S0140-6736(20)31553-1"},{"endpoint":"Grade 3 to 4 urethral stricture within 2 years","unit":"%","arms":[{"name":"Adjuvant radiotherapy","n":697,"value":6},{"name":"Observation with salvage radiotherapy","n":699,"value":4}],"p":"0.020","source":"https://doi.org/10.1016/S0140-6736(20)31553-1"}],"replication":"RAVES (333 men) and GETUG-AFU 17 (424 men) found the same, and the prospectively planned ARTISTIC meta-analysis of all three trials (2,153 men) found an event-free survival hazard ratio of 0.95 (0.75 to 1.21)."},{"id":"nct06949111","kind":"trial","name":"Radiotherapy + Systemic Therapy as Conversion Therapy for pMMR/MSS T4M0 Colon Cancer（Neo-Color）","aka":[],"tldr":"A phase 2 trial of cAPOX (capecitabine, oxaliplatin) and capecitabine in colorectal cancer, run by Hebei Medical University Fourth Hospital, now recruiting.","summary":"Radiotherapy + Systemic Therapy as Conversion Therapy for pMMR/MSS T4M0 Colon Cancer（Neo-Color） is a phase 2, randomised interventional study registered as NCT06949111 by Hebei Medical University Fourth Hospital, with a registry enrolment figure of 128 participants, started 2025-05-15 and due to reach its primary completion in 2028-05-30. Interventions recorded: radiotherapy; CAPOX; Capecitabine; Iparomlimab and Tuvonralimab Injection. Conditions listed: Colon Cancer. Primary outcome: Tumor Complete Response (CR) Rate. Colorectal eligibility wording from the registry: \"Histopathologically confirmed diagnosis of colon adenocarcinoma (including mucinous adenocarcinoma), identified as pMMR/MSS type; the primary tumor site must be specified (left colon defined as from the splenic flexure to the rectosigmoid junction, right colon defined as from the cecum to the proxim\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06949111","url":"https://clinicaltrials.gov/study/NCT06949111"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capox","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06949111","phase":"2","setting":"Efficacy and Safety of Conversion Therapy for pMMR/MSS T4M0 Colon Cancer Patients Treated With Radiotherapy and Systemic Therapy: a Prospective, Open-label, Multi-center, Randomized Controlled Trial（Neo-Color）","sponsor":"Hebei Medical University Fourth Hospital","started":"2025-05-15","startedType":"actual","enrolled":128,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07116577","kind":"trial","name":"Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC","aka":[],"tldr":"A phase 2 trial of iparomlimab and tuvonralimab, trifluridine/tipiracil and bevacizumab (glioblastoma use) in colorectal cancer, run by Jinan Central Hospital, not yet recruiting.","summary":"Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC is a phase 2, interventional study registered as NCT07116577 by Jinan Central Hospital, with a registry enrolment figure of 37 participants, started 2025-08-31 and due to reach its primary completion in 2027-08-31. Interventions recorded: Palliative radiotherapy; Iparomlimab and tuvonralimab; TAS-102; Bevacizumab. Conditions listed: mCRC. Primary outcome: ORR. Colorectal eligibility wording from the registry: \"* Histologically confirmed unresectable colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07116577","url":"https://clinicaltrials.gov/study/NCT07116577"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["iparomlimab-tuvonralimab","trifluridine-tipiracil","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07116577","phase":"2","setting":"A Single-Arm, Exploratory Study of Palliative Radiotherapy Combined With Iparomlimab and Tuvonralimab, Trifluridine/Tipiracil (TAS-102), and Bevacizumab in Later-Line Treatment of Advanced Colorectal Cancer","sponsor":"Jinan Central Hospital","started":"2025-08-31","startedType":"estimated","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07774754","kind":"trial","name":"Radiotherapy Combined With Capeox Chemotherapy, Sintilimab and Suvemcitug in Locally Advanced pMMR Rectal Cancer:a Prospective Clinical Trial","aka":["RADIANT"],"tldr":"A phase 2 trial of sintilimab and capecitabine in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"Radiotherapy Combined With Capeox Chemotherapy, Sintilimab and Suvemcitug in Locally Advanced pMMR Rectal Cancer:a Prospective Clinical Trial is a phase 2, interventional study registered as NCT07774754 by Sun Yat-sen University, with a registry enrolment figure of 18 participants, started 2026-09-01 and due to reach its primary completion in 2028-01-01. Interventions recorded: Drug：sintilimab; Drug：Capecitabine; Drug：Suvemcitug; Radiation: Neoadjuvant Radiotherapy. Conditions listed: Rectal Cancer. Primary outcome: Serious Adverse Effects of Neoadjuvant Therapy. Colorectal eligibility wording from the registry: \"3\\) Histologically confirmed rectal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07774754","url":"https://clinicaltrials.gov/study/NCT07774754"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["sintilimab","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07774754","phase":"2","setting":"Radiotherapy Combined With Capeox Chemotherapy, Sintilimab and Suvemcitug in Locally Advanced pMMR Rectal Cancer:a Prospective Clinical Trial","sponsor":"Sun Yat-sen University","started":"2026-09-01","startedType":"estimated","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07291401","kind":"trial","name":"Radiotherapy Plus CAPOX, and Iparomlimab and Tuvonralimab (QL1706) as Neoadjuvant Therapy for LARC","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Zhongnan Hospital, now recruiting.","summary":"Radiotherapy Plus CAPOX, and Iparomlimab and Tuvonralimab (QL1706) as Neoadjuvant Therapy for LARC is a phase 2, interventional study registered as NCT07291401 by Zhongnan Hospital, with a registry enrolment figure of 108 participants, started 2025-11-01 and due to reach its primary completion in 2027-01-01. Interventions recorded: lparomlimab and Tuvonralimab Injection and CPAOX and radiotherapy. Conditions listed: Rectal Cancer Patients. Primary outcome: Complete response (CR). Colorectal eligibility wording from the registry: \"* (1) The patient is histologically diagnosed with rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07291401","url":"https://clinicaltrials.gov/study/NCT07291401"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07291401","phase":"2","setting":"Neoadjuvant Chemoradiotherapy Combined Cith Iparomlimab and Tuvonralimab (QL1706) Therapy for Locally Advanced Rectal Cancer：a Single-center, Prospective, Single-arm, Open-label, Phase II Clinical Trial","sponsor":"Zhongnan Hospital","started":"2025-11-01","startedType":"actual","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06911684","kind":"trial","name":"Radiotherapy Plus Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as Neoadjuvant Therapy for pMMR/MSS LARC.","aka":[],"tldr":"A phase 2 trial of regorafenib in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Radiotherapy Plus Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as Neoadjuvant Therapy for pMMR/MSS LARC. is a phase 2, randomised interventional study registered as NCT06911684 by Sun Yat-sen University, with a registry enrolment figure of 88 participants, started 2025-04-30 and due to reach its primary completion in 2026-04-30. Interventions recorded: lparomlimab and Tuvonralimab Injection and regorafenib and CPAOX and short-course radiotherapy; lparomlimab and Tuvonralimab Injection and regorafenib and CPAOX and short-course radiotherapy. Conditions listed: Rectal Cancer Patients. Primary outcome: Complete response (CR). Colorectal eligibility wording from the registry: \"Pathology: Histologically confirmed rectal adenocarcinoma, with the lower tumor edge ≤12 cm from the anal verge\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06911684","url":"https://clinicaltrials.gov/study/NCT06911684"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["antiangiogenic","imrt-igrt","kinase-inhibitors"],"targets":[],"drugs":["regorafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06911684","phase":"2","setting":"Short-Term Radiotherapy Combined With Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX Neoadjuvant Therapy for Locally Advanced Rectal Cancer：A Multicenter, Prospective, Randomized, Phase II Clinical Trial","sponsor":"Sun Yat-sen University","started":"2025-04-30","startedType":"actual","enrolled":88,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06686771","kind":"trial","name":"Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer","aka":["CURB2"],"tldr":"A phase 3 trial in lung cancer, run by Canadian Cancer Trials Group, now recruiting.","summary":"Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT06686771 by Canadian Cancer Trials Group, with a registry enrolment figure of 320 participants, started 2025-12-16 and due to reach its primary completion in 2030-02-28. Interventions recorded: SBRT; First or second-line standard of care therapy. Conditions listed: Non-small Cell Lung Cancer. Primary outcome: Progression-free survival; Overall survival. Lung eligibility wording from the registry: \"* Metastatic disease (stage IV) detected on imaging and histologically and/or cytologically confirmed NSCLC as per the WHO Classification of Tumors and AJCC 8th Edition TNM Classification, without a driver mutation with an actionable first-line targeted therapy, for whom either ICI alone or combinat\". Sites: Canada, United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06686771","url":"https://clinicaltrials.gov/study/NCT06686771"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":["cctg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06686771","phase":"3","setting":"Consolidative Use of Radiotherapy to Block (CURB2) Oligoprogression In Patients With Metastatic Non-Small-Cell Lung Cancer","sponsor":"Canadian Cancer Trials Group","started":"2025-12-16","startedType":"actual","enrolled":320,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06250972","kind":"trial","name":"Radiotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer","aka":["PTCA199-11"],"tldr":"A phase 3 trial in pancreatic cancer, run by Fudan University, now recruiting.","summary":"Radiotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer is a phase 3, randomised interventional study registered as NCT06250972 by Fudan University, with a registry enrolment figure of 210 participants, started 2024-05-15 and due to reach its primary completion in 2027-05-01. Interventions recorded: Gemcitabine, Nab-paclitaxel, Irinotecan; Intensity-Modulated Radiation Therapy (IMRT). Conditions listed: Pancreatic Adenocarcinoma. Primary outcome: progression-free survival, PFS. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed advanced pancreas adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06250972","url":"https://clinicaltrials.gov/study/NCT06250972"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06250972","phase":"3","setting":"Radiotherapy Plus Chemotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer Who Are Not Refractory to Chemotherapy","sponsor":"Fudan University","started":"2024-05-15","startedType":"actual","enrolled":210,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07632118","kind":"trial","name":"Radiotherapy With GX Regimen as Adjuvant Therapy for High-risk Patients Following Pancreatic Cancer Surgery","aka":[],"tldr":"A phase 3 trial in pancreatic cancer, run by Tianjin Medical University Cancer Institute and Hospital, now recruiting.","summary":"Radiotherapy With GX Regimen as Adjuvant Therapy for High-risk Patients Following Pancreatic Cancer Surgery is a phase 3, randomised interventional study registered as NCT07632118 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 288 participants, started 2026-05-22 and due to reach its primary completion in 2029-05. Interventions recorded: Radiotherapy + GX; GX group. Conditions listed: Pancreatic Cancer. Primary outcome: DFS. Pancreatic eligibility wording from the registry: \"* Confirmed as pancreatic ductal adenocarcinoma by histopathology or cytology, with no evidence of distant metastasis confirmed by imaging\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07632118","url":"https://clinicaltrials.gov/study/NCT07632118"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac","metastatic-pdac"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07632118","phase":"3","setting":"A Prospective, Multicenter, Randomized Controlled Phase III Study on Radiotherapy Combined With GX Regimen as Adjuvant Therapy for High-risk Patients Following Pancreatic Cancer Surgery","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2026-05-22","startedType":"estimated","enrolled":288,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06573398","kind":"trial","name":"Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC","aka":[],"tldr":"A phase 2 trial of tislelizumab in pancreatic cancer, run by Ruijin Hospital, not yet recruiting.","summary":"Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC is a phase 2, interventional study registered as NCT06573398 by Ruijin Hospital, with a registry enrolment figure of 20 participants, started 2024-09-01 and due to reach its primary completion in 2025-09-01. Interventions recorded: SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin. Conditions listed: Carcinoma, Pancreatic Ductal. Primary outcome: R0 resection rate. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of pancreas;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06573398","url":"https://clinicaltrials.gov/study/NCT06573398"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","sbrt"],"targets":[],"drugs":["tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06573398","phase":"2","setting":"Efficacy and Safety of Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for Borderline Resectable Pancreatic Cancer","sponsor":"Ruijin Hospital","started":"2024-09-01","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"rainbo","kind":"trial","name":"RAINBO","aka":["RAINBO programme","POLEmut-BLUE","p53abn-RED","MMRd-GREEN","NSMP-ORANGE"],"tldr":"RAINBO is a programme of four trials that tailors treatment after surgery for womb cancer to the tumour's molecular type; in its POLEmut-BLUE arm, women whose tumours carry a POLE mutation and almost never relapse have chemotherapy withheld and receive radiotherapy alone or no further treatment, and the results are awaited.","summary":"RAINBO (Refining Adjuvant treatment IN endometrial cancer Based On molecular features) is an international programme registered by Leiden University Medical Center with ENGOT, the Canadian Cancer Trials Group and University College London as trial sponsors, planned for 1,615 patients. It assigns endometrial cancer after surgery to one of four trials by molecular class: p53abn-RED randomises chemoradiotherapy with or without olaparib; MMRd-GREEN randomises pelvic radiotherapy with or without durvalumab against chemoradiotherapy; NSMP-ORANGE tests progestin with radiotherapy against chemoradiotherapy; and POLEmut-BLUE, a single-arm de-escalation study, gives radiotherapy alone or observation to stage I to II and selected stage III POLE-mutated tumours. Each trial's primary endpoint is measured at three years.\n\nThe registry lists the programme as recruiting with completion in 2031 and no results. The corpus's POLE-ultramutated endometrial cancer page cites RAINBO POLEmut-BLUE for pelvic radiotherapy without chemotherapy.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05255653","url":"https://clinicaltrials.gov/study/NCT05255653"}],"tags":["soc-trials"],"related":[],"cancers":["endometrial-pole-ultramutated","endometrial-mmr-deficient"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["olaparib","durvalumab","megestrol"],"companies":[],"institutions":["lumc-leiden"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05255653","phase":"2/3","setting":"Endometrial cancer stratified by molecular class after surgery: four linked trials that test olaparib with chemoradiotherapy for p53-abnormal tumours (p53abn-RED), durvalumab with radiotherapy for mismatch-repair-deficient tumours (MMRd-GREEN), progestin with radiotherapy for tumours with no specific molecular profile (NSMP-ORANGE), and de-escalation to radiotherapy alone or observation for POLE-ultramutated tumours (POLEmut-BLUE)","sponsor":"Leiden University Medical Center (RAINBO Research Consortium)","started":"2021-11-11","startedType":"actual","enrolled":1615,"enrolledBasis":"registry","outcomes":[]},{"id":"rainbow","kind":"trial","name":"RAINBOW","aka":[],"tldr":"Made ramucirumab plus paclitaxel the standard second-line stomach cancer treatment, a role it held for a decade until Enhertu and Claudin drugs arrived.","summary":"RAINBOW, trial NCT01170663 sponsored by Eli Lilly and reported in Lancet Oncology in 2014, made ramucirumab plus paclitaxel the standard second-line treatment for advanced gastric and gastro-oesophageal junction cancer, a role it held for a decade until trastuzumab deruxtecan and Claudin 18.2 drugs arrived. It randomised 665 patients to ramucirumab or placebo with paclitaxel and met its primary overall survival endpoint, and with REGARD, which tested ramucirumab alone, it established VEGFR2 blockade in gastric cancer. OnCo links it to gastric cancer, VEGF as a target, ramucirumab, paclitaxel and Min-Hee Ryu, and the result is consistent with REGARD and RAINBOW-Asia. It remains the second-line standard for HER2-negative disease and the comparator in DESTINY-Gastric04 and CLARITY-Gastric01, and how long it keeps that role is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01170663","url":"https://clinicaltrials.gov/study/NCT01170663"}],"tags":[],"related":[],"cancers":["gastric"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":["vegf"],"drugs":["ramucirumab","paclitaxel"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ryu-min-hee"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01170663","phase":"3","setting":"Second-line advanced gastric/GEJ cancer: ramucirumab + paclitaxel vs paclitaxel","sponsor":"Eli Lilly","result":"OS 9.6 vs 7.4 months, HR 0.81.","started":"2010-12","yearReported":2014,"enrolled":665,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Ramucirumab + paclitaxel","n":330,"value":9.6},{"name":"Placebo + paclitaxel","n":335,"value":7.4}],"hr":0.81,"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70420-6/abstract"}],"replication":"Consistent with REGARD (monotherapy OS benefit) and RAINBOW-Asia."},{"id":"rainfol-01","kind":"trial","name":"RAINFOL-01 (Rina-S)","aka":[],"tldr":"A next-generation folate-receptor ADC that works even in tumours with low folate receptor, with responses in both ovarian and endometrial cancer.","summary":"Ovarian cohort: confirmed ORR 55.6% at 120 mg/m² (n=20) and 22.7% at 100 mg/m² (n=22) with long follow-up; endometrial cohort (n=64, after anti-PD-1 and platinum): ORR 50% at 100 mg/m² including complete responses, earning Breakthrough Therapy designation. Phase 3 RAINFOL-02 in platinum-resistant ovarian cancer is enrolling, with primary completion expected in 2027. Unlike mirvetuximab, benefit is not restricted to FRα-high tumours.","status":"active","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05579366","url":"https://clinicaltrials.gov/study/NCT05579366"}],"tags":[],"related":[],"cancers":["ovarian","endometrial"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["folr1"],"drugs":["rinatabart-sesutecan"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05579366","phase":"1/2","setting":"Advanced ovarian and endometrial cancer, heavily pretreated: rinatabart sesutecan (FRα ADC, exatecan payload) across FRα expression levels","sponsor":"Genmab","result":"ORR 55.6% (ovarian, 120 mg/m²); 50% (endometrial, 100 mg/m²).","started":"2022-12-07","startedType":"actual","yearReported":2025,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate, ovarian, 120 mg/m²","unit":"%","arms":[{"name":"Rina-S","n":20,"value":55.6}],"source":"https://www.cancernetwork.com/view/rina-s-elicits-encouraging-antitumor-activity-in-advanced-ovarian-cancer"},{"endpoint":"Objective response rate, endometrial, 100 mg/m²","unit":"%","arms":[{"name":"Rina-S","value":50}],"source":"https://www.cancernetwork.com/view/rina-s-earns-fda-breakthrough-therapy-designation-in-endometrial-cancer"}]},{"id":"raise","kind":"trial","name":"RAISE","aka":[],"tldr":"Switching from one blood-vessel drug to another after progression gave about six extra weeks, the same small gain as aflibercept.","summary":"RAISE randomised 1,072 patients whose metastatic colorectal cancer had progressed during or within six months of first-line bevacizumab, oxaliplatin and a fluoropyrimidine to second-line FOLFIRI with ramucirumab 8 mg/kg or placebo. Median overall survival was 13.3 against 11.7 months. Ramucirumab blocks VEGF receptor 2 rather than the ligand, and the result shows that continued blockade of the pathway after progression helps a little but does not overcome resistance. It is not funded for colorectal cancer in England.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01183780","url":"https://clinicaltrials.gov/study/NCT01183780"},{"label":"RAISE: ramucirumab with second-line FOLFIRI in metastatic colorectal carcinoma (Lancet Oncology 2015)","url":"https://doi.org/10.1016/S1470-2045(15)70127-0"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":["vegf"],"drugs":["ramucirumab","folfiri"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":["velour"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01183780","phase":"3","setting":"Metastatic colorectal cancer progressing on first-line bevacizumab, oxaliplatin and a fluoropyrimidine: FOLFIRI with ramucirumab or placebo","sponsor":"Eli Lilly","result":"Median overall survival 13.3 against 11.7 months.","started":"2010-12-02","startedType":"actual","yearReported":2015,"enrolled":1072,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"FOLFIRI plus ramucirumab","n":536,"value":13.3},{"name":"FOLFIRI plus placebo","n":536,"value":11.7}],"source":"https://doi.org/10.1016/S1470-2045(15)70127-0"}]},{"id":"ramp-201","kind":"trial","name":"RAMP 201","aka":[],"tldr":"RAMP 201 produced the first approved treatment designed for low-grade serous ovarian cancer, a slow-growing type driven by the RAS pathway that shrugs off chemotherapy.","summary":"In KRAS-mutant tumours, the confirmed response rate was 44% with median PFS 19.6 months and median duration of response 31.1 months; response was lower in KRAS-wild-type disease (Targeted Oncology, 2025). FDA accelerated approval 8 May 2025 for KRAS-mutated recurrent LGSOC after prior systemic therapy. The confirmatory RAMP 301 phase 3 versus chemotherapy or endocrine therapy is ongoing.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04625270","url":"https://clinicaltrials.gov/study/NCT04625270"},{"label":"MSK on approval","url":"https://www.mskcc.org/news/fda-approves-avutometinib-defactinib-combination-for-treating-recurrent-low-grade-serous-ovarian-cancer-with-kras-mutation"}],"tags":[],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["kras"],"drugs":["avutometinib-defactinib"],"companies":["verastem"],"institutions":[],"pathways":["ras-mapk"],"terms":["lgsoc"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04625270","phase":"2","setting":"Recurrent low-grade serous ovarian cancer: avutometinib (RAF/MEK clamp) + defactinib (FAK inhibitor)","sponsor":"Verastem","result":"ORR 44%, median PFS 19.6 months in KRAS-mutant LGSOC.","started":"2020-12-21","startedType":"actual","yearReported":2024,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (KRAS-mutant)","primary":true,"unit":"%","arms":[{"name":"Avutometinib + defactinib","value":44}],"source":"https://www.targetedonc.com/view/avutometinib-plus-defactinib-gains-fda-approval-in-kras-ovarian-cancer"},{"endpoint":"Progression-free survival (KRAS-mutant)","unit":"months","arms":[{"name":"Avutometinib + defactinib","value":19.6}],"source":"https://www.targetedonc.com/view/avutometinib-plus-defactinib-gains-fda-approval-in-kras-ovarian-cancer"}]},{"id":"nct07562659","kind":"trial","name":"Randomized Controlled Study of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy in Stage I/Low-Risk Stage II Colorectal Cancer","aka":["CLEAR-01"],"tldr":"A phase 2 trial of capecitabine in colorectal cancer, run by Fudan University, now recruiting.","summary":"Randomized Controlled Study of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy in Stage I/Low-Risk Stage II Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07562659 by Fudan University, with a registry enrolment figure of 80 participants, started 2024-11-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: Capecitabine. Conditions listed: ctDNA; Colorectal Cancer (CRC); Adjuvant Chemotherapy. Primary outcome: Patient's 2-year Progression-Free Survival. Colorectal eligibility wording from the registry: \"Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07562659","url":"https://clinicaltrials.gov/study/NCT07562659"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","mrd-testing"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07562659","phase":"2","setting":"A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decisions in Postoperative Stage I or Low-Risk Stage II Colorectal Cancer Patients","sponsor":"Fudan University","started":"2024-11-01","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02768363","kind":"trial","name":"Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)","aka":["ULYSSES"],"tldr":"A phase 2 trial of Aglatimagene besadenovec in prostate cancer, run by Candel Therapeutics, Inc., active and no longer recruiting.","summary":"Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES) is a phase 2 interventional study registered as NCT02768363 by Candel Therapeutics, Inc., with 187 participants enrolled, started 2016-05 and due to reach its primary completion in 2024-11. Interventions recorded: aglatimagene besadenovec, placebo, valacyclovir. Conditions listed: Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02768363","url":"https://clinicaltrials.gov/study/NCT02768363"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-low-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["aglatimagene-besadenovec"],"companies":["candel-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02768363","phase":"2","setting":"A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer","sponsor":"Candel Therapeutics, Inc.","started":"2016-05","enrolled":187,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06867705","kind":"trial","name":"Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only","aka":[],"tldr":"A phase 3 trial of Resilience PRO in advanced solid tumours, run by Resilience, now recruiting.","summary":"Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only is a phase 3 interventional study registered as NCT06867705 by Resilience, with 1458 participants planned, started 2025-04-01 and due to reach its primary completion in 2027-01. Interventions recorded: Resilience PRO.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06867705","url":"https://clinicaltrials.gov/study/NCT06867705"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06867705","phase":"3","setting":"Digital Monitoring With Patient-Reported Outcomes in Cancer Care: A Randomized Controlled Trial RC - 102 (Resilience Care - 102)","sponsor":"Resilience","started":"2025-04-01","startedType":"actual","enrolled":1458,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03722420","kind":"trial","name":"Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)","aka":[],"tldr":"A phase 3 trial of Imatinib in chronic myeloid leukaemia, run by Il-Yang Pharm. Co., Ltd., active and no longer recruiting.","summary":"Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China) is a phase 3 interventional study registered as NCT03722420 by Il-Yang Pharm. Co., Ltd., with 238 participants enrolled, started 2018-12-28 and due to reach its primary completion in 2023-03-03. Interventions recorded: Radotinib and Imatinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03722420","url":"https://clinicaltrials.gov/study/NCT03722420"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cml","cml-chronic-phase"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["imatinib","radotinib"],"companies":["il-yang-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03722420","phase":"3","setting":"A Phase III, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Chinese Patients in Chronic Phase","sponsor":"Il-Yang Pharm. Co., Ltd.","started":"2018-12-28","startedType":"actual","enrolled":238,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01059786","kind":"trial","name":"Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia","aka":[],"tldr":"A phase 2 trial of Pentostatin, Rituximab and Bendamustine in Hairy cell leukaemia, run by National Cancer Institute (NCI), active and no longer recruiting.","summary":"Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia is a phase 2 interventional study registered as NCT01059786 by National Cancer Institute (NCI), with 69 participants planned, started 2010-07-01 and due to reach its primary completion in 2022-12-15. Interventions recorded: Pentostatin, Rituximab, Bendamustine, Acetaminophen, Diphenhydramine, Epinephrine, Antihistamines, Corticosteroids, Bronchodilators, Intravenous (IV) Saline. Conditions recorded: Hairy Cell Leukemia.\n\nLinked to the drug Pentostatin because the registry names it among its interventions and Hairy cell leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01059786","url":"https://clinicaltrials.gov/study/NCT01059786"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hairy-cell-leukemia"],"sections":[],"technologies":[],"targets":[],"drugs":["pentostatin","rituximab","bendamustine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01059786","phase":"2","setting":"Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia","sponsor":"National Cancer Institute (NCI)","started":"2010-07-01","startedType":"actual","enrolled":69,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04747236","kind":"trial","name":"Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL","aka":[],"tldr":"A phase 2 trial of Azacitidine, Romidepsin, Belinostat, Pralatrexate and Gemcitabine in Peripheral T-cell lymphomas, run by University of Virginia, now recruiting.","summary":"Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL is a phase 2 interventional study registered as NCT04747236 by University of Virginia, with 50 participants planned, started 2021-02-19 and due to reach its primary completion in 2028-06-02. Interventions recorded: Azacytidine, Romidepsin, Belinostat, Pralatrexate, Gemcitabine. Conditions recorded: PTCL.\n\nLinked to the drug Romidepsin because the registry names it among its interventions and Peripheral T-cell lymphomas among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04747236","url":"https://clinicaltrials.gov/study/NCT04747236"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["azacitidine","romidepsin","belinostat","pralatrexate","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04747236","phase":"2","setting":"A Randomized, Phase IIB, Multicenter, Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in Patients With Relapse or Refractory Peripheral T-cell Lymphoma (PTCL)","sponsor":"University of Virginia","started":"2021-02-19","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00431080","kind":"trial","name":"Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer","aka":[],"tldr":"A phase 3 trial of Docetaxel, Paclitaxel / nab-paclitaxel, Epirubicin, Cyclophosphamide, Fluorouracil, Lenograstim and Pegfilgrastim in Breast cancer, run by Hellenic Oncology Research Group, completed.","summary":"Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer is a phase 3 interventional study registered as NCT00431080 by Hellenic Oncology Research Group, with 478 participants recorded, started 2004-08 and reaching its primary completion in 2007-10. Interventions recorded: Docetaxel, Paclitaxel, Epirubicin, Cyclophosphamide, 5-fluoruracil, Granulocyte-colony stimulating growth factor. Conditions recorded: Breast Cancer.\n\nLinked to the drug Lenograstim because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00431080","url":"https://clinicaltrials.gov/study/NCT00431080"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["docetaxel","paclitaxel","epirubicin","cyclophosphamide","fluorouracil","lenograstim","pegfilgrastim"],"companies":["horg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00431080","phase":"3","setting":"A Multicenter Randomized Study Comparing the Dose Dense, G-CSF-Supported Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Women With Axillary Lymph Node Positive Breast Cancer","sponsor":"Hellenic Oncology Research Group","started":"2004-08","enrolled":478,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07562711","kind":"trial","name":"Randomized Study of Plasma ctDNA Methylation to Guide Adjuvant Chemotherapy Decisions in High-Risk T3N0 Colorectal Cancer","aka":["CLEAR-02"],"tldr":"A phase 2 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Fudan University, now recruiting.","summary":"Randomized Study of Plasma ctDNA Methylation to Guide Adjuvant Chemotherapy Decisions in High-Risk T3N0 Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07562711 by Fudan University, with a registry enrolment figure of 340 participants, started 2024-11-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: Capecitabine; FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin). Conditions listed: ctDNA; Chemotherapy; Colorectal Cancer. Primary outcome: Patient's 2-year Progression-Free Survival. Colorectal eligibility wording from the registry: \"Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07562711","url":"https://clinicaltrials.gov/study/NCT07562711"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","mrd-testing","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07562711","phase":"2","setting":"Randomized Study of Plasma ctDNA Methylation to Guide Adjuvant Chemotherapy Decisions in High-Risk T3N0 Colorectal Cancer","sponsor":"Fudan University","started":"2024-11-01","startedType":"actual","enrolled":340,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07562503","kind":"trial","name":"Randomized Trial of Plasma ctDNA Methylation-Guided Adjuvant Therapy in T4N0 and Low-Risk Stage III Colorectal Cancer","aka":["CLEAR-03"],"tldr":"A phase 2 trial of cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Fudan University, now recruiting.","summary":"Randomized Trial of Plasma ctDNA Methylation-Guided Adjuvant Therapy in T4N0 and Low-Risk Stage III Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07562503 by Fudan University, with a registry enrolment figure of 340 participants, started 2024-11-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: CAPEOX regimen; CAPEOX regimen. Conditions listed: ctDNA; Colorectal Cancer; Chemotherapy. Primary outcome: Patient's 2-year Progression-Free Survival. Colorectal eligibility wording from the registry: \"Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07562503","url":"https://clinicaltrials.gov/study/NCT07562503"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","mrd-testing","platinum"],"targets":[],"drugs":["capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07562503","phase":"2","setting":"Randomized Trial of Plasma ctDNA Methylation-Guided Adjuvant Therapy in T4N0 and Low-Risk Stage III Colorectal Cancer","sponsor":"Fudan University","started":"2024-11-01","startedType":"actual","enrolled":340,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04457245","kind":"trial","name":"Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Piflufolastat F-18 / Pylarify TruVu in Prostate cancer, run by Jonsson Comprehensive Cancer Center, recorded as terminated on the registry.","summary":"Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer is a phase 3 interventional study registered as NCT04457245 by Jonsson Comprehensive Cancer Center, with 54 participants recorded, started 2020-08-14 and due to reach its primary completion in 2023-01-10. Interventions recorded: Computed Tomography, Fluorine F 18 DCFPyL, Positron Emission Tomography, Radiation Therapy. Conditions recorded: Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8.\n\nLinked to the drug Piflufolastat F-18 / Pylarify TruVu because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04457245","url":"https://clinicaltrials.gov/study/NCT04457245"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["pylarify"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04457245","phase":"3","setting":"Phase 3 Randomized Trial Of PSMA PET Prior to Definitive Radiation Therapy for Unfavorable Intermediate-Risk or High-Risk Prostate Cancer [PSMA dRT]","sponsor":"Jonsson Comprehensive Cancer Center","started":"2020-08-14","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01843374","kind":"trial","name":"Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma","aka":[],"tldr":"A phase 2 trial of Tremelimumab in mesothelioma, run by MedImmune LLC, active and no longer recruiting.","summary":"Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma is a phase 2 interventional study registered as NCT01843374 by MedImmune LLC, with 571 participants enrolled, started 2013-05-17 and due to reach its primary completion in 2016-01-24. Interventions recorded: Tremelimumab, Placebo. Conditions listed: Unresectable Pleural or Peritoneal Malignant Mesothelioma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01843374","url":"https://clinicaltrials.gov/study/NCT01843374"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mesothelioma","peritoneal-mesothelioma","pleural-mesothelioma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tremelimumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01843374","phase":"2","setting":"A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects With Unresectable Pleural or Peritoneal Malignant Mesothelioma","sponsor":"MedImmune LLC","started":"2013-05-17","startedType":"actual","enrolled":571,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00189345","kind":"trial","name":"Randomized, Multicenter, 2-Dose Level. Open-Label, Phase IIa Study With the Intraperitoneally Infused Trifunctional Bispecific Antibody Removab(TM) (Anti-EpCAM x Anti-CD3) to Select the Better Dose Level in Platinum Refractory Epithelial Ovarian Cancer Patients","aka":[],"tldr":"A phase 2 trial of Catumaxomab in Ovarian cancer, run by AGO Study Group, completed.","summary":"Randomized, Multicenter, 2-Dose Level. Open-Label, Phase IIa Study With the Intraperitoneally Infused Trifunctional Bispecific Antibody Removab(TM) (Anti-EpCAM x Anti-CD3) to Select the Better Dose Level in Platinum Refractory Epithelial Ovarian Cancer Patients is a phase 2 interventional study registered as NCT00189345 by AGO Study Group, with 44 participants recorded, started 2004-05. Interventions recorded: anti-EpCAM x anti-CD3 (removab). Conditions recorded: Ovarian Cancer, Fallopian Tube Neoplasms, Peritoneal Neoplasms.\n\nLinked to the drug Catumaxomab because the registry names it among its interventions and Ovarian cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00189345","url":"https://clinicaltrials.gov/study/NCT00189345"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["catumaxomab"],"companies":["ago-study-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00189345","phase":"2","setting":"Randomized, Multicenter, 2-Dose Level. Open-Label, Phase IIa Study With the Intraperitoneally Infused Trifunctional Bispecific Antibody Removab(TM) (Anti-EpCAM x Anti-CD3) to Select the Better Dose Level in Platinum Refractory Epithelial Ovarian Cancer Patients","sponsor":"AGO Study Group","started":"2004-05","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03051464","kind":"trial","name":"Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery","aka":["MORPHEUS"],"tldr":"A phase 2/3 trial in colorectal cancer, run by Sir Mortimer B. Davis - Jewish General Hospital, now recruiting.","summary":"Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery is a phase 2/3, randomised interventional study registered as NCT03051464 by Sir Mortimer B. Davis - Jewish General Hospital, with a registry enrolment figure of 131 participants, started 2017-04-25 and due to reach its primary completion in 2028-01. Interventions recorded: Complete responders and Non-complete responders; Chemoradiation + EBRT Boost; Chemoradiation + HDRBT Boost. Conditions listed: Stage II Rectal Cancer; Organ Preservation; Non-operative Treatment; Rectal Cancer (Stage III); Rectal Cancer Patients. Primary outcome: TME-free survival. Colorectal eligibility wording from the registry: \"* Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic/trans-rectal ultrasound\". Sites: Canada, United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03051464","url":"https://clinicaltrials.gov/study/NCT03051464"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03051464","phase":"2/3","setting":"A Phase III Study Testing Two Dose Escalation Strategies to Increase the Population of Complete Responders After Radiation Therapy in the Context of Organ Preservation for Patients With Rectal Cancer","sponsor":"Sir Mortimer B. Davis - Jewish General Hospital","started":"2017-04-25","startedType":"actual","enrolled":131,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05144698","kind":"trial","name":"RAPA-201 Therapy of Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Rapa Therapeutics LLC, now recruiting.","summary":"RAPA-201 Therapy of Solid Tumors is a phase 1/2 interventional study registered as NCT05144698 by Rapa Therapeutics LLC, with 37 participants planned, started 2021-08-01 and due to reach its primary completion in 2026-01-01. Interventions recorded: RAPA-201 Rapamycin Resistant T Cells, Chemotherapy Prior to RAPA-201 Therapy, Pembrolizumab (PD-1 Blocking Antibody). Conditions listed: Solid Tumor, Small Cell and Non-small Cell Lung Cancer, Head and Neck Cancer, Squamous Cell Carcinoma of Oral Cavity. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05144698","url":"https://clinicaltrials.gov/study/NCT05144698"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05144698","phase":"1/2","setting":"Phase I/II Trial of Autologous Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy of PD-(L)1 Resistant Solid Tumors","sponsor":"Rapa Therapeutics LLC","started":"2021-08-01","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"rapid","kind":"trial","name":"RAPID (accelerated partial-breast irradiation)","aka":["RAPID trial","OCOG RAPID"],"tldr":"Treating only the part of the breast around the tumour worked as well as treating all of it, but giving the dose twice a day made the breast look worse years later. The lesson is about the timetable, not the target.","summary":"RAPID randomised 2,135 women aged 40 or over with ductal carcinoma in situ or node-negative breast cancer at 33 centres in Canada, Australia and New Zealand between 2006 and 2011, to external beam accelerated partial-breast irradiation of 38.5 Gy in ten fractions given twice daily over five to eight days, or to whole-breast irradiation of 42.5 Gy in sixteen or 50 Gy in twenty-five daily fractions.\n\nAt a median 8.6 years, the eight-year cumulative rate of ipsilateral breast tumour recurrence was 3.0 percent with partial-breast treatment (95 percent confidence interval 1.9 to 4.0) and 2.8 percent with whole-breast treatment (1.8 to 3.9), a hazard ratio of 1.27 (90 percent confidence interval 0.84 to 1.91), which met the pre-specified non-inferiority margin.\n\nThe toxicity split in two directions. Acute grade 2 or worse toxicity was less common with partial-breast treatment, 28 against 45 percent (p<0.0001). Late grade 2 or worse toxicity was much more common, 32 against 13 percent (p<0.0001), and adverse cosmesis was more common at three years (absolute difference 11.3 percent), five years (16.5 percent) and seven years (17.7 percent).\n\nThe trial's own interpretation is that the twice-daily timetable, not the smaller volume, is the likely cause, and that once-daily partial-breast schedules should be studied. IMPORT LOW, which delivered partial-breast treatment once a day in fifteen fractions with ordinary tangential fields, found fewer changes in breast appearance than whole-breast treatment, which supports that reading. The record is marked mixed because the cancer endpoint was met and the cosmetic endpoint was not.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00282035","url":"https://clinicaltrials.gov/study/NCT00282035"},{"label":"RAPID (The Lancet 2019)","url":"https://doi.org/10.1016/S0140-6736(19)32515-2"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc","ductal-carcinoma-in-situ"],"sections":[],"technologies":["imrt-igrt","hypofractionated-radiotherapy"],"targets":[],"drugs":[],"companies":["cctg"],"institutions":[],"pathways":[],"terms":["partial-breast-irradiation","hypofractionation"],"trials":["import-low","nsabp-b39","targit-a"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00282035","phase":"3","setting":"Women aged 40 or over with ductal carcinoma in situ or node-negative breast cancer after breast-conserving surgery: external beam accelerated partial-breast irradiation of 38.5 Gy in ten fractions twice a day over five to eight days, against whole-breast irradiation, with ipsilateral breast tumour recurrence as the primary endpoint","sponsor":"Ontario Clinical Oncology Group","result":"Eight-year ipsilateral breast tumour recurrence 3.0 percent with twice-daily partial-breast irradiation against 2.8 percent with whole-breast irradiation (non-inferior), with late toxicity 32 against 13 percent and adverse cosmesis 17.7 percentage points more common at seven years.","started":"2006-01","yearReported":2019,"enrolled":2135,"enrolledBasis":"registry","outcomes":[{"endpoint":"Ipsilateral breast tumour recurrence at 8 years","primary":true,"unit":"%","arms":[{"name":"Accelerated partial-breast irradiation, 38.5 Gy in 10 twice-daily fractions","n":1070,"value":3,"note":"95 percent confidence interval 1.9 to 4.0"},{"name":"Whole-breast irradiation","n":1065,"value":2.8,"note":"95 percent confidence interval 1.8 to 3.9"}],"hr":1.27,"ci":[0.84,1.91],"source":"https://doi.org/10.1016/S0140-6736(19)32515-2"},{"endpoint":"Late radiation toxicity, grade 2 or worse","unit":"%","arms":[{"name":"Accelerated partial-breast irradiation","n":1070,"value":32},{"name":"Whole-breast irradiation","n":1065,"value":13}],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(19)32515-2"}],"replication":"IMPORT LOW and NSABP B-39/RTOG 0413 tested partial-breast irradiation in the same population with different schedules and reached different conclusions about cosmesis, so the schedule, not the idea of treating part of the breast, is what the three trials disagree about."},{"id":"rapido","kind":"trial","name":"RAPIDO","aka":[],"tldr":"RAPIDO showed that giving one week of radiotherapy and then all the chemotherapy before surgery cuts distant spread and doubles complete responses in high-risk rectal cancer, establishing total neoadjuvant therapy.","summary":"RAPIDO randomised 920 patients with high-risk rectal cancer on MRI to short-course radiotherapy (25 Gy in five fractions) followed by six cycles of CAPOX or nine of FOLFOX then surgery, or to standard capecitabine chemoradiation, surgery and optional adjuvant chemotherapy. Disease-related treatment failure at three years was 23.7 percent with the experimental approach versus 30.4 percent, driven by fewer distant metastases, and pathological complete response doubled to 28 percent (Bahadoer and colleagues, Lancet Oncology 2020). Later follow-up reported more local regrowth in the experimental arm, tempering enthusiasm for the shortest radiotherapy.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01558921","url":"https://clinicaltrials.gov/study/NCT01558921"},{"label":"Lancet Oncology 2020","url":"https://doi.org/10.1016/S1470-2045(20)30555-6"}],"tags":["radiation-wave4"],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["hypofractionated-radiotherapy","imrt-igrt"],"targets":[],"drugs":["capecitabine","oxaliplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["stellar-rectal","stockholm-iii","dutch-tme-trial","iwwd"],"people":[],"bottlenecks":[],"keyPapers":["paper-bahadoer-rapido-short-course-radiotherapy-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01558921","phase":"3","setting":"High-risk locally advanced rectal cancer: short-course radiotherapy then chemotherapy before surgery (total neoadjuvant therapy) versus standard chemoradiation, surgery and optional adjuvant chemotherapy","sponsor":"University Medical Centre Groningen","result":"3-year disease-related treatment failure 23.7% vs 30.4%; pathological complete response 28% vs 14%.","started":"2011-06-21","startedType":"actual","yearReported":2020,"enrolled":920,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-related treatment failure at 3 years","primary":true,"unit":"%","arms":[{"name":"Total neoadjuvant therapy","n":462,"value":23.7},{"name":"Standard chemoradiation","n":450,"value":30.4}]}]},{"id":"nct01200485","kind":"trial","name":"Rasburicase in Patients at High Risk for Tumor Lysis Syndrome (TLS) During Cycle-2","aka":[],"tldr":"A phase 2 trial of Rasburicase in Leukaemia, run by M.D. Anderson Cancer Center, completed.","summary":"Rasburicase in Patients at High Risk for Tumor Lysis Syndrome (TLS) During Cycle-2 is a phase 2 interventional study registered as NCT01200485 by M.D. Anderson Cancer Center, with 55 participants recorded, started 2011-04 and reaching its primary completion in 2016-07. Interventions recorded: Rasburicase, Allopurinol. Conditions recorded: Leukemia, Lymphoma.\n\nLinked to the drug Rasburicase because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01200485","url":"https://clinicaltrials.gov/study/NCT01200485"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["rasburicase"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01200485","phase":"2","setting":"A Randomized Phase 2 Study to Evaluate the Efficacy of Rasburicase in Patients at Risk for TLS During Two Cycles of Chemotherapy","sponsor":"M.D. Anderson Cancer Center","started":"2011-04","yearReported":2020,"enrolled":55,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants (Incidence) of LTLS (Laboratory Tumor Lysis Syndrome)","primary":true,"unit":"participants","arms":[{"name":"Arm A (Rasburicase)","n":21,"value":1,"note":"Figures from the ClinicalTrials.gov results section (first posted 2020-01-31), not from a publication"},{"name":"Arm B (Allopurinol)","n":25,"value":1}],"source":"https://clinicaltrials.gov/study/NCT01200485?tab=results"}]},{"id":"rasolute-302","kind":"trial","name":"RASolute 302","aka":[],"tldr":"The trial that nearly doubled survival in previously treated pancreatic cancer, presented in the ASCO 2026 plenary. The biggest result in the disease's history.","summary":"500 patients, 59 sites. Topline 13 April 2026; presented by Brian Wolpin (Dana-Farber) at the ASCO 2026 plenary (31 May) with simultaneous NEJM publication. Median OS 13.2 vs 6.7 months (HR 0.40, p<0.0001); PFS also significantly improved. The NDA (220910) was received by the FDA on 17 July 2026 and approved on 26 August 2026 as Rasonque for metastatic pancreatic adenocarcinoma after at least one prior systemic therapy. First-line (RASolute 303) and adjuvant (RASolute 304) trials follow.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT06625320","url":"https://clinicaltrials.gov/study/NCT06625320"},{"label":"FDA approval notice (26 Aug 2026)","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma"},{"label":"Revolution Medicines announcement","url":"https://ir.revmed.com/news-releases/news-release-details/daraxonrasib-demonstrates-unprecedented-overall-survival-benefit"},{"label":"JCO abstract LBA5","url":"https://ascopubs.org/doi/10.1200/JCO.2026.44.17_suppl.LBA5"},{"label":"O'Reilly et al., RASolute 302 (NEJM 2026)","url":"https://doi.org/10.1056/NEJMoa2605555"},{"label":"Rasonque label (openFDA): RASolute 302 efficacy table and adverse reactions","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22RASONQUE%22"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["kras-inhibitors"],"targets":["kras"],"drugs":["daraxonrasib"],"companies":["revolution-medicines"],"institutions":["dana-farber"],"pathways":[],"terms":[],"trials":["nct07491445","nct07252232","codebreak-100","napoli-1","conko-003"],"people":[],"bottlenecks":[],"keyPapers":["paper-bournet-kras-g12d-prognosis-pancreatic-ctg-2016"],"journals":[],"dependsOn":[],"notes":["Primary paper (NEJM 2026) and label: 500 patients, 91.8 percent with RAS G12 mutations, randomised 1 to 1 to daraxonrasib 300 mg daily or investigator's choice chemotherapy after one prior line; dual primary endpoints in the RAS G12 population were overall survival 13.2 against 6.6 months and progression-free survival 7.3 against 3.5 months (hazard ratios 0.40 and 0.45); in the overall population 13.2 against 6.7 months (hazard ratio 0.40) and 7.2 against 3.6 months (hazard ratio 0.49; label 95 percent confidence interval 0.38 to 0.64), response 30 against 11 percent. Grade 3 or higher adverse events 61.8 against 69.6 percent; treatment-related discontinuation 1.2 against 11.2 percent. Registry: sites in the United States, France, Germany, Italy, Japan, Puerto Rico and Spain, none in the UK; primary completion June 2026. Label (effective 27 August 2026): indicated after at least one prior systemic therapy or for adults not candidates for multi-agent chemotherapy; dose interruptions in 69 percent (rash 27, stomatitis 20 percent)."],"nct":"NCT06625320","phase":"3","setting":"Metastatic PDAC after one prior line of chemotherapy: daraxonrasib vs investigator's choice chemotherapy","sponsor":"Revolution Medicines","result":"OS 13.2 vs 6.7 months, HR 0.40.","started":"2024-10-16","startedType":"actual","yearReported":2026,"enrolled":500,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Daraxonrasib","value":13.2},{"name":"Chemotherapy (gemcitabine/nab-paclitaxel or mFOLFOX6)","value":6.7}],"hr":0.4,"source":"https://clinicaltrials.gov/study/NCT06625320"},{"endpoint":"Progression-free survival by blinded independent central review (overall population)","unit":"months","arms":[{"name":"Daraxonrasib","n":248,"value":7.2,"note":"95% CI 5.7 to 7.5"},{"name":"Chemotherapy (mFOLFIRINOX, gemcitabine/nab-paclitaxel, FOLFOX or liposomal irinotecan with 5-FU/LV)","n":252,"value":3.6,"note":"95% CI 2.9 to 4.2"}],"hr":0.49,"ci":[0.38,0.64],"p":"<0.0001","source":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22RASONQUE%22"},{"endpoint":"Objective response rate by blinded independent central review (overall population)","unit":"%","arms":[{"name":"Daraxonrasib","n":248,"value":30,"note":"95% CI 25 to 36"},{"name":"Chemotherapy","n":252,"value":11,"note":"95% CI 7 to 15"}],"p":"<0.0001","source":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22RASONQUE%22"}],"replication":"Single pivotal trial reported 2026; consistent with the phase 1/2 signal (median OS ~14.5 months in second line). First-line RASolute 303 ongoing."},{"id":"rathl","kind":"trial","name":"RATHL","aka":[],"tldr":"Showed that patients whose PET scan is clear after two cycles can safely drop bleomycin and its lung toxicity.","summary":"RATHL, trial NCT00678327 sponsored by the UK NCRI and Cancer Research UK and published in the New England Journal of Medicine in 2016, showed that patients with advanced Hodgkin lymphoma whose PET scan is clear after two cycles can safely drop bleomycin and its lung toxicity. It enrolled 1,214 patients, randomised those with a negative interim PET to continue ABVD or switch to AVD, met its non-inferiority endpoint on progression-free survival with fewer pulmonary events, and escalated PET-positive patients to BEACOPP. OnCo links it to Hodgkin lymphoma, PET-adapted therapy, FDG PET, the Deauville scale term, Cancer Research UK, Peter Johnson and the bleomycin caution pairing, and it is concordant with GHSG HD18. It established interim PET as a treatment-steering tool, and whether PET can guide even deeper de-escalation is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00678327","url":"https://clinicaltrials.gov/study/NCT00678327"}],"tags":[],"related":["lymphoma-roadmap","hd18","ahl2011","eortc-h10"],"cancers":["hodgkin-lymphoma","advanced-stage-classical-hodgkin-lymphoma"],"sections":[],"technologies":["pet-adapted-therapy","fdg-pet"],"targets":[],"drugs":["bleomycin"],"companies":[],"institutions":["cruk"],"pathways":[],"terms":["deauville-score"],"trials":[],"people":["peter-johnson"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00678327","phase":"3","setting":"Advanced Hodgkin lymphoma: interim-PET-guided omission of bleomycin (AVD) vs continued ABVD","sponsor":"UK NCRI / Cancer Research UK","result":"3-year PFS 85.7% (ABVD) vs 84.4% (AVD); bleomycin safely omitted.","started":"2008-08-29","startedType":"actual","yearReported":2016,"enrolled":1214,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 3 years (PET2-negative)","primary":true,"unit":"%","arms":[{"name":"ABVD","n":470,"value":85.7},{"name":"AVD","n":465,"value":84.4}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1510093"}],"replication":"Concordant with GHSG HD18 (shortened BEACOPP after negative PET2)."},{"id":"ratify","kind":"trial","name":"RATIFY (CALGB 10603)","aka":[],"tldr":"The trial that made FLT3 the first targetable mutation in AML: adding midostaurin to chemotherapy tripled median survival.","summary":"3,277 patients screened to randomise 717 with FLT3-ITD or TKD mutations. Median OS 74.7 vs 25.6 months (HR 0.78, 95% CI 0.63-0.96, p=0.009); 4-year OS 51.4% vs 44.3%; benefit across ITD allelic ratio and TKD subgroups and irrespective of transplant. NEJM 2017. Established the template of TKI added to intensive induction that QuANTUM-First later refined.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00651261","url":"https://clinicaltrials.gov/study/NCT00651261"},{"label":"NEJM 2017","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1614359"}],"tags":[],"related":[],"cancers":["aml","aml-flt3"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["flt3"],"drugs":["midostaurin","cytarabine-7-3"],"companies":["alliance-oncology","novartis"],"institutions":[],"pathways":[],"terms":["flt3-itd-allelic-ratio","eln-risk"],"trials":[],"people":["richard-stone"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00651261","phase":"3","setting":"Newly diagnosed FLT3-mutated AML, age 18-59: midostaurin vs placebo added to 7+3, consolidation, and one year of maintenance","sponsor":"Alliance / Novartis","result":"Median OS 74.7 vs 25.6 months; HR 0.78.","started":"2008-04","startedType":"actual","yearReported":2017,"enrolled":717,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Midostaurin + 7+3","n":360,"value":74.7},{"name":"Placebo + 7+3","n":357,"value":25.6}],"hr":0.78,"ci":[0.63,0.96],"p":"0.009","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1614359"},{"endpoint":"4-year overall survival","unit":"%","arms":[{"name":"Midostaurin","value":51.4},{"name":"Placebo","value":44.3}],"source":"https://doi.org/10.1056/NEJMoa1614359"}],"replication":"QuANTUM-First (quizartinib) independently confirmed that FLT3 inhibition added to 7+3 improves OS in FLT3-ITD AML; real-world registries reproduce the RATIFY benefit in patients up to age 70."},{"id":"mcc-rational-treatment","kind":"trial","name":"Rational treatment selection for Merkel cell carcinoma","aka":["ISRCTN16290169"],"tldr":"The only randomised trial ever attempted in Merkel cell carcinoma, run from Birmingham, closed to recruitment in 2018, and with no published result on its registry record: the reason the first treatment decision in this cancer is still made on opinion.","summary":"Merkel cell carcinoma is rare enough that almost every treatment decision in it rests on retrospective series. This trial asked the one question that matters most at diagnosis, whether radical surgery or radical radiotherapy gives better loco-regional control as first definitive treatment, and it is the only randomised attempt at it. The registry entry gives a target of 400, recruitment from 31 March 2016 to 30 December 2018 and an overall end date of 30 September 2020, and lists no publication.\n\nIt belongs on a UK page because the failure it represents is a UK service problem as much as a scientific one: a cancer that is out of scope for the genomic test directory, has no patient charity of its own, is counted inside a generic Skin heading in three of the four nations' waiting-time statistics, and whose one randomised trial has left no public answer. What the NHS does fund for it is avelumab, which is on the national list for both the untreated and the previously treated metastatic settings.","status":"completed","asOf":"2026-09-25","links":[{"label":"ISRCTN16290169","url":"https://www.isrctn.com/ISRCTN16290169"}],"tags":["uk","skin","merkel-cell-carcinoma","rare"],"related":[],"cancers":["merkel-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["avelumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN16290169","phase":"3","setting":"UK multicentre randomised phase 3 trial comparing radical surgery with radical radiotherapy as first definitive treatment for primary Merkel cell carcinoma, with a parallel observational study for people ineligible for randomisation; primary outcome time from randomisation to loco-regional treatment failure over two years of follow-up; recruitment 31 March 2016 to 30 December 2018, registered overall end date 30 September 2020","sponsor":"University of Birmingham","result":"Recruitment closed 30 December 2018; the ISRCTN record lists no publication (ISRCTN16290169).","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"rationale-302","kind":"trial","name":"RATIONALE-302","aka":[],"tldr":"The global trial in which tislelizumab beat chemotherapy for oesophageal cancer that had progressed after first treatment, which carried it to approval in the US, Europe and Japan.","summary":"512 patients from 11 countries. Median overall survival 8.6 versus 6.3 months (hazard ratio 0.70), with greater benefit at PD-L1 TAP 10% or more (10.3 versus 6.8 months). Because it enrolled outside China it underpinned the EU approval (2023), the first FDA approval of tislelizumab (March 2024) and Japanese approval, in contrast to the China-only PD-1 filings that failed in the US.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03430843","url":"https://clinicaltrials.gov/study/NCT03430843"},{"label":"J Clin Oncol 2022","url":"https://doi.org/10.1200/JCO.21.01926"}],"tags":["china"],"related":[],"cancers":["esophageal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-shen-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03430843","phase":"3","setting":"Second-line advanced or metastatic oesophageal squamous cell carcinoma, global (Asia, Europe, North America): tislelizumab vs investigator's choice chemotherapy","sponsor":"BeiGene (BeOne Medicines)","result":"OS 8.6 vs 6.3 months, HR 0.70.","started":"2018-01-26","startedType":"actual","yearReported":2022,"enrolled":512,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Tislelizumab","n":256,"value":8.6},{"name":"Chemotherapy","n":256,"value":6.3}],"hr":0.7,"source":"https://doi.org/10.1200/JCO.21.01926"}]},{"id":"rationale-306","kind":"trial","name":"RATIONALE-306","aka":[],"tldr":"RATIONALE-306 is the trial behind tislelizumab's US approval for squamous oesophageal cancer, with the biggest gains in PD-L1-positive tumours.","summary":"RATIONALE-306, trial NCT03783442 sponsored by BeOne, formerly BeiGene, and reported in 2022, is the trial behind tislelizumab's US approval for first-line advanced oesophageal squamous cell carcinoma, with the biggest gains in PD-L1-positive tumours. It randomised 649 patients to tislelizumab or placebo with platinum chemotherapy and met its primary overall survival endpoint in all patients, published in Lancet Oncology in 2023, with a larger effect in PD-L1-positive disease; the FDA approved it on 4 March 2025 restricted to PD-L1 tumour area positivity of one percent or more, and the EU approved it in 2024. OnCo links it to oesophageal cancer, PD-1 as a target and tislelizumab, and the result is consistent with KEYNOTE-590, CheckMate 648 and ESCORT-1st. Whether a fifth PD-1 antibody in this setting competes on price rather than data is the practical question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03783442","url":"https://clinicaltrials.gov/study/NCT03783442"}],"tags":[],"related":[],"cancers":["esophageal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["tislelizumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03783442","phase":"3","setting":"First-line advanced oesophageal squamous cell carcinoma: tislelizumab + platinum chemotherapy vs placebo + chemotherapy","sponsor":"BeOne (BeiGene)","result":"OS 17.2 vs 10.6 months (HR 0.66); PD-L1 ≥1% OS 16.8 vs 9.6 months.","started":"2018-12-11","startedType":"actual","yearReported":2022,"enrolled":649,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, all patients","primary":true,"unit":"months","arms":[{"name":"Tislelizumab + chemotherapy","n":326,"value":17.2},{"name":"Placebo + chemotherapy","n":323,"value":10.6}],"hr":0.66,"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00108-0/abstract"},{"endpoint":"Overall survival, PD-L1 ≥1%","unit":"months","arms":[{"name":"Tislelizumab + chemotherapy","value":16.8},{"name":"Placebo + chemotherapy","value":9.6}],"source":"https://www.onclive.com/view/fda-approves-first-line-tislelizumab-plus-chemotherapy-for-unresectable-or-metastatic-escc"}],"replication":"Consistent with KEYNOTE-590, CheckMate 648, ESCORT-1st."},{"id":"raves","kind":"trial","name":"RAVES (TROG 08.03/ANZUP)","aka":["RAVES","TROG 08.03","ANZUP RAVES"],"tldr":"Waiting for the PSA to rise before giving radiotherapy after prostate surgery gave the same cancer control and spared half the men pelvic radiation, though the trial closed too early to prove it formally.","summary":"RAVES randomised 333 men across 32 oncology centres in Australia and New Zealand, 166 to adjuvant radiotherapy within 6 months of prostatectomy and 167 to early salvage radiotherapy triggered by a PSA of 0.20 ng/mL or more. Radiotherapy in both arms was 64 Gy in 32 fractions to the prostate bed without androgen deprivation, with real-time review of plan quality before treatment.\n\nAn independent data monitoring committee recommended premature closure of enrolment because event rates were unexpectedly low. At a median 6.1 years, 84 of 167 men (50 percent) in the salvage group had been triggered to treatment. Five-year freedom from biochemical progression was 86 percent (95 percent confidence interval 81 to 92) with adjuvant radiotherapy and 87 percent (82 to 93) with salvage, stratified hazard ratio 1.12 (0.65 to 1.90). Non-inferiority, which required the upper bound to stay under 1.48, was not formally met (p=0.15).\n\nToxicity separated cleanly. Grade 2 or worse genitourinary toxicity occurred in 90 of 167 men (54 percent) in the salvage group against 116 of 166 (70 percent) in the adjuvant group. Gastrointestinal toxicity was similar (10 against 14 percent). The authors concluded that the data support salvage radiotherapy despite the formal failure, because it gives similar biochemical control, spares about half of men pelvic radiation and causes significantly less genitourinary toxicity.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00860652","url":"https://clinicaltrials.gov/study/NCT00860652"},{"label":"RAVES (Lancet Oncology 2020)","url":"https://doi.org/10.1016/S1470-2045(20)30456-3"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk","prostate-bcr"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["anzup"],"institutions":[],"pathways":[],"terms":["prostatectomy","salvage-therapy","biochemical-recurrence","neoadjuvant-adjuvant"],"trials":["radicals-rt","getug-afu-17","artistic-meta-analysis"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00860652","phase":"3","setting":"Prostate cancer after radical prostatectomy with positive margins, extraprostatic extension or seminal vesicle invasion and a postoperative PSA of 0.10 or less: adjuvant radiotherapy of 64 Gy in 32 fractions within 6 months against early salvage radiotherapy triggered by a PSA of 0.20 or more, without androgen deprivation, with freedom from biochemical progression as the primary endpoint and a non-inferiority design","sponsor":"Trans-Tasman Radiation Oncology Group and ANZUP Cancer Trials Group","result":"Five-year freedom from biochemical progression 87 percent with early salvage against 86 percent with adjuvant radiotherapy (hazard ratio 1.12, 95 percent confidence interval 0.65 to 1.90); formal non-inferiority not met (p=0.15), but grade 2 or worse genitourinary toxicity 54 against 70 percent.","started":"2009-03-03","startedType":"actual","yearReported":2020,"enrolled":333,"enrolledBasis":"randomised","enrolledNote":"333 men were randomised before an independent data monitoring committee recommended premature closure of enrolment because event rates were unexpectedly low.","outcomes":[{"endpoint":"Freedom from biochemical progression at 5 years","primary":true,"unit":"%","arms":[{"name":"Early salvage radiotherapy","n":167,"value":87},{"name":"Adjuvant radiotherapy","n":166,"value":86}],"hr":1.12,"ci":[0.65,1.9],"p":"0.15 for non-inferiority","source":"https://doi.org/10.1016/S1470-2045(20)30456-3"},{"endpoint":"Grade 2 or worse genitourinary toxicity","unit":"%","arms":[{"name":"Early salvage radiotherapy","n":167,"value":54},{"name":"Adjuvant radiotherapy","n":166,"value":70}],"source":"https://doi.org/10.1016/S1470-2045(20)30456-3"}],"replication":"RADICALS-RT and GETUG-AFU 17 found the same, and the ARTISTIC meta-analysis pooled all three."},{"id":"sqnsclc","kind":"trial","name":"RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Small Cell Lung Cancer (sqNSCLC)","aka":[],"tldr":"A phase 3 trial testing RC148 in non-small-cell lung cancer, now recruiting.","summary":"RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Small Cell Lung Cancer (sqNSCLC) is a phase 3 interventional study registered as NCT07416474, led by RemeGen, and recruiting on the registry. Official title: Randomised, Double-Blind, Multicenter Phase III Study of RC148 in Combination With Platinum-Based Chemotherapy Versus Tislelizumab in Combination With Platinum-Based Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer. Planned enrolment is 574 participants (estimated). The study started in 2026-04-03 and primary completion is expected in 2027-12-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07416474","url":"https://clinicaltrials.gov/study/NCT07416474"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["rc148"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07416474","phase":"3","setting":"Randomized, Double-Blind, Multicenter Phase III Study of RC148 in Combination With Platinum-Based Chemotherapy Versus Tislelizumab in Combination With Platinum-Based Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer","sponsor":"RemeGen","started":"2026-04-03","startedType":"actual","enrolled":574,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07366840","kind":"trial","name":"RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure","aka":[],"tldr":"A phase 2/3 trial of Disitamab vedotin, Gemcitabine, Capecitabine, Trastuzumab and Inetetamab in HER2-positive breast cancer and Breast cancer, run by Fudan University, not yet recruiting.","summary":"RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure is a phase 2/3 interventional study registered as NCT07366840 by Fudan University, with 268 participants planned, started 2026-01-16 and due to reach its primary completion in 2028-01-16. Interventions recorded: Disitamab Vedotin, Gemcitabine, Capecitabine, Trastuzumab, Inetetamab. Conditions recorded: HER2-positive Breast Cancer, Metastatic Breast Cancer.\n\nLinked to the drug Inetetamab because the registry names it among its interventions and HER2-positive breast cancer and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07366840","url":"https://clinicaltrials.gov/study/NCT07366840"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["disitamab-vedotin","gemcitabine","capecitabine","trastuzumab","inetetamab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07366840","phase":"2/3","setting":"A Phase 3, Randomized Advanced Breast Cancer Study Investigating RC48 Combined With Chemotherapy Versus Guideline-recommended Trastuzumab/Inetetamab Plus Chemotherapy in HER2-Positive Patients With Prior TOP1i-ADC Failure","sponsor":"Fudan University","started":"2026-01-16","startedType":"estimated","enrolled":268,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07419880","kind":"trial","name":"Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer","aka":["RECLAIM"],"tldr":"A phase 2 trial of TQB2102 in triple-negative breast cancer, run by Fudan University, not yet recruiting.","summary":"Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer is a phase 2, interventional study registered as NCT07419880 by Fudan University, with a registry enrolment figure of 46 participants, started 2026-01-30 and due to reach its primary completion in 2027-01-30. Interventions recorded: Cromolyn, TQB2102, and Panpulimab. Conditions listed: Triple -Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Diagnosis: Histologically confirmed invasive triple-negative breast cancer (defined as: ER-negative by IHC with \\<1% positive tumor cells; PR-negative with \\<1% positive tumor cells; HER2 0-1+ or HER2 2+ with confirmed negative FISH/CISH without amplification)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07419880","url":"https://clinicaltrials.gov/study/NCT07419880"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb2102"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07419880","phase":"2","setting":"RECLAIM: Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer","sponsor":"Fudan University","started":"2026-01-30","startedType":"estimated","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05807984","kind":"trial","name":"Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Xin Cai, not yet recruiting.","summary":"Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion is a phase 2, interventional study registered as NCT05807984 by Xin Cai, with a registry enrolment figure of 31 participants, started 2023-05-01 and due to reach its primary completion in 2025-12-31. Interventions recorded: Carbon ion radiation therapy DT: 74Gy/20 fractions. Conditions listed: Rectal Cancer; Recurrent. Primary outcome: local control. Colorectal eligibility wording from the registry: \"* 1\\) pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis,\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05807984","url":"https://clinicaltrials.gov/study/NCT05807984"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05807984","phase":"2","setting":"A Prospective Phase II Clinical Study of Carbon Ion Re-irradiation in Unresectable Locally Recurrent Rectal Cancer","sponsor":"Xin Cai","started":"2023-05-01","startedType":"estimated","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"reach-2","kind":"trial","name":"REACH-2","aka":[],"tldr":"REACH-2 showed that the antibody ramucirumab helped people with liver cancer live longer after sorafenib, but only when a blood marker, alpha-fetoprotein, was high, making it the first liver cancer drug approved on a biomarker.","summary":"The earlier REACH trial of ramucirumab, an antibody against VEGF receptor 2, missed its overall survival endpoint in the whole population but showed a benefit in patients with an alpha-fetoprotein of 400 ng/mL or more. REACH-2 tested exactly that group: patients with advanced hepatocellular carcinoma who had progressed on or were intolerant of sorafenib were randomised two to one to ramucirumab or placebo, with overall survival as the primary endpoint.\n\nRamucirumab lengthened overall survival and progression-free survival compared with placebo, confirming the biomarker hypothesis, and was approved in the United States in May 2019 for this population, the first biomarker-selected approval in hepatocellular carcinoma.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02435433","url":"https://clinicaltrials.gov/study/NCT02435433"}],"tags":["subtype-trials"],"related":[],"cancers":["hcc-advanced","hcc"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["ramucirumab"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["andrew-zhu"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02435433","phase":"3","setting":"Advanced hepatocellular carcinoma after sorafenib with a baseline alpha-fetoprotein of 400 ng/mL or more: ramucirumab against placebo","sponsor":"Eli Lilly","result":"Ramucirumab improved overall survival over placebo in alpha-fetoprotein-high hepatocellular carcinoma after sorafenib; approved in May 2019.","started":"2015-07-20","startedType":"actual","yearReported":2019,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Ramucirumab 8 mg/kg","n":197,"value":8.5,"note":"Median follow-up 7.6 months"},{"name":"Placebo","n":95,"value":7.3}],"hr":0.71,"ci":[0.531,0.949],"p":"0.0199","source":"https://doi.org/10.1016/s1470-2045(18)30937-9"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Ramucirumab 8 mg/kg","n":197,"value":2.8},{"name":"Placebo","n":95,"value":1.6}],"hr":0.452,"ci":[0.339,0.603],"p":"<0.0001","source":"https://doi.org/10.1016/s1470-2045(18)30937-9"},{"endpoint":"Objective response","unit":"%","arms":[{"name":"Ramucirumab 8 mg/kg","n":197,"value":5},{"name":"Placebo","n":95,"value":1}],"p":"0.1697","source":"https://doi.org/10.1016/s1470-2045(18)30937-9"},{"endpoint":"Grade 3 or worse hypertension","unit":"%","arms":[{"name":"Ramucirumab 8 mg/kg","n":197,"value":13},{"name":"Placebo","n":95,"value":5}],"source":"https://doi.org/10.1016/s1470-2045(18)30937-9"}]},{"id":"ready-dasatinib","kind":"trial","name":"READY","aka":["READY","CA180-227","dasatinib with docetaxel"],"tldr":"Blocking Src, the kinase that lets prostate cancer cells talk to bone-dissolving cells, did nothing when added to chemotherapy.","summary":"Src kinase mediates the crosstalk between prostate cancer cells and osteoclasts, and preclinical work suggested that inhibiting it would be synergistic with docetaxel. READY was the test.\n\nIt randomised 1,522 men with chemotherapy-naive metastatic castration-resistant prostate cancer to docetaxel and prednisone with dasatinib 100 mg once daily or placebo, blinded to patients, investigators and analysts.\n\nAt the final analysis, median follow-up 19.0 months and 914 deaths, median overall survival was 21.5 months (95 percent confidence interval 20.3 to 22.8) with dasatinib and 21.2 months (20.0 to 23.4) with placebo, stratified hazard ratio 0.99 (95.5 percent confidence interval 0.87 to 1.13, p=0.90).\n\nThe commonest grade 3 to 4 adverse events with dasatinib against placebo were diarrhoea (58 of 762, 8 percent, against 27 of 760, 4 percent), fatigue (62, 8 percent, against 42, 6 percent) and asthenia (40, 5 percent, against 23, 3 percent). Grade 3 to 4 pleural effusions, the toxicity dasatinib is known for in leukaemia, were uncommon at 10 (1 percent) against three (under 1 percent).\n\nREADY belongs with COMET-1, CALGB 90401 and the endothelin trials in the group of bone-microenvironment hypotheses that produced large, well-conducted, completely null trials.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00744497","url":"https://clinicaltrials.gov/study/NCT00744497"},{"label":"READY (Lancet Oncology 2013)","url":"https://doi.org/10.1016/S1470-2045(13)70479-0"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":["src"],"drugs":["dasatinib","docetaxel","prednisone"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["bone-metastases","castration-resistance"],"trials":["comet-1","calgb-90401","swog-s0421-atrasentan"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00744497","phase":"3","setting":"Chemotherapy-naive metastatic castration-resistant prostate cancer with adequate organ function, stratified by ECOG performance status, bisphosphonate use and urinary N-telopeptide: docetaxel 75 mg/m2 every 3 weeks with prednisone 5 mg twice daily, plus dasatinib 100 mg once daily or placebo, with overall survival as the primary endpoint","sponsor":"Bristol-Myers Squibb","result":"Median overall survival 21.5 against 21.2 months (stratified hazard ratio 0.99, 95.5 percent confidence interval 0.87 to 1.13, p=0.90): no benefit.","started":"2008-10","yearReported":2013,"enrolled":1522,"enrolledBasis":"randomised","enrolledNote":"1,522 eligible men were randomly assigned between 30 October 2008 and 11 April 2011 at 186 centres in 25 countries, 762 to dasatinib and 760 to placebo.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Docetaxel, prednisone and dasatinib","n":762,"value":21.5,"note":"Confidence interval is 95.5 percent, as reported."},{"name":"Docetaxel, prednisone and placebo","n":760,"value":21.2}],"hr":0.99,"ci":[0.87,1.13],"p":"0.90","source":"https://doi.org/10.1016/S1470-2045(13)70479-0"}],"replication":"Consistent with the other bone-microenvironment failures: COMET-1, CALGB 90401, SWOG S0421 and ENTHUSE M1."},{"id":"nct07006077","kind":"trial","name":"Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of Recombinant human IL-21-expressing oncolytic vaccinia virus injection in pancreatic ductal adenocarcinoma, run by Hangzhou Converd Co., Ltd., now recruiting.","summary":"Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advanced Pancreatic Cancer is a phase 2 interventional study registered as NCT07006077 by Hangzhou Converd Co., Ltd., with 12 participants planned, started 2025-05-29 and due to reach its primary completion in 2028-12-31. Interventions recorded: Recombinant human IL-21-expressing oncolytic vaccinia virus injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07006077","url":"https://clinicaltrials.gov/study/NCT07006077"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07006077","phase":"2","setting":"A Phase II Trial to Evaluate the Efficacy of Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Patients With Advanced Pancreatic Tumors","sponsor":"Hangzhou Converd Co., Ltd.","started":"2025-05-29","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"recourse","kind":"trial","name":"RECOURSE","aka":[],"tldr":"An oral chemotherapy tablet that still works after fluorouracil has stopped working, because the active part is built into DNA rather than blocking an enzyme.","summary":"RECOURSE randomised 800 patients with refractory metastatic colorectal cancer 2:1 to trifluridine/tipiracil (TAS-102) or placebo. Median overall survival improved from 5.3 to 7.1 months (hazard ratio 0.68, 95% CI 0.58 to 0.81). Trifluridine is incorporated into DNA rather than inhibiting thymidylate synthase, which is why it retains activity after fluoropyrimidine failure, and tipiracil blocks its degradation. Neutropenia is the main toxicity. The FDA approved it in September 2015, the EU marketing authorisation for Lonsurf followed on 25 April 2016 and NICE recommended it in England in August 2016 (TA405). SUNLIGHT later showed that adding bevacizumab is better still.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01607957","url":"https://clinicaltrials.gov/study/NCT01607957"},{"label":"RECOURSE: randomized trial of TAS-102 for refractory metastatic colorectal cancer (New England Journal of Medicine 2015)","url":"https://doi.org/10.1056/NEJMoa1414325"},{"label":"NICE TA405: trifluridine-tipiracil for previously treated metastatic colorectal cancer","url":"https://www.nice.org.uk/guidance/ta405"},{"label":"EMA Lonsurf","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lonsurf"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["trifluridine-tipiracil"],"companies":["taiho","servier"],"institutions":[],"pathways":[],"terms":[],"trials":["sunlight"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01607957","phase":"3","setting":"Refractory metastatic colorectal cancer after all standard chemotherapies: trifluridine/tipiracil against placebo","sponsor":"Taiho Oncology","result":"Median overall survival 7.1 against 5.3 months (hazard ratio 0.68).","started":"2012-06-17","startedType":"actual","yearReported":2015,"enrolled":800,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Trifluridine/tipiracil","value":7.1},{"name":"Placebo","value":5.3}],"hr":0.68,"ci":[0.58,0.81],"source":"https://doi.org/10.1056/NEJMoa1414325"}],"replication":"Superseded in practice by SUNLIGHT, which added bevacizumab and reached 10.8 months."},{"id":"nct07735624","kind":"trial","name":"RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer","aka":["RECTIFY-1"],"tldr":"A phase 2 trial of botensilimab and balstilimab in colorectal cancer, run by Dana-Farber Cancer Institute, now recruiting.","summary":"RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer is a phase 2, interventional study registered as NCT07735624 by Dana-Farber Cancer Institute, with a registry enrolment figure of 16 participants, started 2026-09 and due to reach its primary completion in 2027-01-01. Interventions recorded: Botensilimab; Balstilimab. Conditions listed: Early Rectal Cancer; Stage I Rectal Cancer; Microsatellite Stable Rectal Carcinoma. Primary outcome: Complete response (cCR plus nCR with pCR at resection) within 6 months from initiation of therapy or nCR with pathologic complete response (pCR) with TES. Colorectal eligibility wording from the registry: \"* Histologically confirmed diagnosis of early-rectal cancer clinically staged T1-T2 N0 M0 by MRI (American Joint Committee on Cancer (AJCC) staging 8th edition, 2017)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07735624","url":"https://clinicaltrials.gov/study/NCT07735624"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["botensilimab","balstilimab"],"companies":["agenus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07735624","phase":"2","setting":"A Phase 2 Study of the Safety and Efficacy of Neoadjuvant Botensilimab in Combination With Balstilimab in the Treatment of Microsatellite Stable / Mismatch Repair Proficient Early Rectal Cancer (RECTIFY-1)","sponsor":"Dana-Farber Cancer Institute","started":"2026-09","startedType":"estimated","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06411795","kind":"trial","name":"Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Masonic Cancer Center, University of Minnesota, now recruiting.","summary":"Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy is a phase 2, randomised interventional study registered as NCT06411795 by Masonic Cancer Center, University of Minnesota, with a registry enrolment figure of 78 participants, started 2023-11-10 and due to reach its primary completion in 2027-01-01. Interventions recorded: Bupivacaine; Hydromorphone; Iopamidol; Liposomal Bupivacaine; Medical Chart Review; Questionnaire Administration; Thoracic Epidural Analgesia; Ultrasound Imaging; X-Ray Imaging. Conditions listed: Duodenal Neoplasm; Pancreatic Neoplasm. Primary outcome: Milligram morphine equivalents (MME). Pancreatic eligibility wording from the registry: \"* Adult patients, age 18 and older, undergoing open pancreaticoduodenectomy at the University of Minnesota will be included in the study\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06411795","url":"https://clinicaltrials.gov/study/NCT06411795"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06411795","phase":"2","setting":"Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial","sponsor":"Masonic Cancer Center, University of Minnesota","started":"2023-11-10","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"reflect","kind":"trial","name":"REFLECT","aka":[],"tldr":"Lenvatinib matched sorafenib on survival with more tumour shrinkage, giving a second first-line option after a decade.","summary":"REFLECT, trial NCT01761266 sponsored by Eisai and reported in 2018, showed that lenvatinib matched sorafenib on survival with more tumour shrinkage, giving first-line unresectable hepatocellular carcinoma a second option after a decade. It randomised 954 patients in a non-inferiority design, met its primary overall survival endpoint for non-inferiority, and improved progression-free survival and response rate by modified RECIST, making it the first positive first-line trial since SHARP. OnCo links it to hepatocellular carcinoma, lenvatinib, sorafenib, Ann-Lii Cheng and Masatoshi Kudo. Because it showed equivalence rather than superiority, whether lenvatinib's higher response rate matters clinically, particularly before local therapies, remains the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01761266","url":"https://clinicaltrials.gov/study/NCT01761266"}],"tags":[],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["lenvatinib","sorafenib"],"companies":["eisai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ann-lii-cheng","masatoshi-kudo"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01761266","phase":"3","setting":"First-line unresectable HCC: lenvatinib vs sorafenib (non-inferiority)","sponsor":"Eisai","result":"OS 13.6 vs 12.3 months, non-inferior (HR 0.92).","started":"2013-03-01","startedType":"actual","yearReported":2018,"enrolled":954,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Lenvatinib","n":478,"value":13.6},{"name":"Sorafenib","n":476,"value":12.3}],"hr":0.92,"ci":[0.79,1.06],"source":"https://doi.org/10.1016/S0140-6736(18)30207-1"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Lenvatinib","value":7.4},{"name":"Sorafenib","value":3.7}],"hr":0.66,"source":"https://doi.org/10.1016/S0140-6736(18)30207-1"}]},{"id":"nct05870748","kind":"trial","name":"REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1","aka":["REFRaME-O1"],"tldr":"A phase 2/3 trial of Luveltamab tazevibulin, Pegfilgrastim, Gemcitabine, Paclitaxel / nab-paclitaxel, Pegylated liposomal doxorubicin and Topotecan in Ovarian cancer and Platinum-resistant ovarian cancer, run by Sutro Biopharma, Inc., recorded as terminated on the registry.","summary":"REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1 is a phase 2/3 interventional study registered as NCT05870748 by Sutro Biopharma, Inc., with 600 participants recorded, started 2023-07-12 and due to reach its primary completion in 2025-08-26. Interventions recorded: Luveltamab tazevibulin, Pegfilgrastim, Gemcitabine, Paclitaxel, Pegylated liposomal doxorubicin, Topotecan. Conditions recorded: Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Platinum-resistant Ovarian Cancer.\n\nLinked to the drug Luveltamab tazevibulin because the registry names it among its interventions and Ovarian cancer and Platinum-resistant ovarian cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05870748","url":"https://clinicaltrials.gov/study/NCT05870748"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["luveltamab-tazevibulin","pegfilgrastim","gemcitabine","paclitaxel","pegylated-liposomal-doxorubicin","topotecan"],"companies":["sutro-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05870748","phase":"2/3","setting":"REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) Versus Investigator's Choice (IC) Chemotherapy in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)","sponsor":"Sutro Biopharma, Inc.","started":"2023-07-12","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07594106","kind":"trial","name":"REGN15505 (PSMAx4-1BB) Alone or in Combination With Cemiplimab or REGN4336 (PSMAxCD3) in Adult Patients With Metastatic Castration-Resistant Prostate ","aka":[],"tldr":"A phase 1/2 trial of Cemiplimab in prostate cancer and renal cell carcinoma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"REGN15505 (PSMAx4-1BB) Alone or in Combination With Cemiplimab or REGN4336 (PSMAxCD3) in Adult Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma is a phase 1/2 interventional study registered as NCT07594106 by Regeneron Pharmaceuticals, with 265 participants planned, started 2026-07-20 and due to reach its primary completion in 2030-10-27. Interventions recorded: REGN15505, REGN15505+Cemiplimab, REGN15505+REGN4336. Conditions listed: Metastatic Castration-Resistant Prostate Cancer (mCRPC), Clear Cell Renal Cell Carcinoma (ccRCC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07594106","url":"https://clinicaltrials.gov/study/NCT07594106"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","rcc","prostate-mcrpc","clear-cell-rcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07594106","phase":"1/2","setting":"Phase 1/2 Study of REGN15505 (a PSMAx4-1BB Bispecific Antibody) Administered Alone or in Combination With Cemiplimab or REGN4336 (a PSMAxCD3 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma","sponsor":"Regeneron Pharmaceuticals","started":"2026-07-20","startedType":"actual","enrolled":265,"enrolledBasis":"registry","outcomes":[]},{"id":"regobone","kind":"trial","name":"REGOBONE","aka":[],"tldr":"REGOBONE showed that the tablet regorafenib delayed progression of osteosarcoma that had come back after chemotherapy, giving one of the few randomised results in relapsed bone cancer.","summary":"REGOBONE was a French placebo-controlled randomised phase 2 trial run as parallel cohorts by histology in patients aged 10 or older with metastatic bone sarcoma progressing after standard chemotherapy. Patients received regorafenib, a multikinase inhibitor, or placebo with crossover allowed at progression. The primary endpoint was progression-free survival at eight weeks in the osteosarcoma cohort.\n\nThe osteosarcoma cohort met its endpoint, with more patients progression-free at eight weeks and longer median progression-free survival on regorafenib, matching the American SARC024 trial reported at the same time. The Ewing sarcoma cohort also favoured regorafenib, and the chondrosarcoma cohort suggested activity in conventional and dedifferentiated tumours; chordoma results were reported separately. Regorafenib is used at relapse on this evidence though it has no formal approval in bone sarcoma.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02389244","url":"https://clinicaltrials.gov/study/NCT02389244"}],"tags":["subtype-trials"],"related":[],"cancers":["osteosarcoma","ewing-sarcoma","chondrosarcoma","chordoma","sarcoma"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["regorafenib"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["florence-duffaud"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02389244","phase":"2","setting":"Metastatic bone sarcomas after standard chemotherapy: regorafenib against placebo in separate cohorts for osteosarcoma, Ewing sarcoma, chondrosarcoma and chordoma","sponsor":"UNICANCER","result":"Regorafenib improved eight-week progression-free survival over placebo in relapsed osteosarcoma, with signals in the Ewing sarcoma and chondrosarcoma cohorts.","started":"2014-09","startedType":"actual","yearReported":2019,"enrolled":163,"enrolledBasis":"registry","outcomes":[{"endpoint":"Non-progression at 8 weeks, osteosarcoma cohort","primary":true,"unit":"%","arms":[{"name":"Regorafenib 160 mg","n":26,"value":65,"note":"One-sided 95% CI lower bound 47%; 38 evaluable of 43 enrolled"},{"name":"Placebo","n":12,"value":0}],"source":"https://doi.org/10.1016/s1470-2045(18)30742-3"},{"endpoint":"Treatment-related serious adverse events","unit":"%","arms":[{"name":"Regorafenib 160 mg","n":29,"value":24},{"name":"Placebo","n":14,"value":0}],"source":"https://doi.org/10.1016/s1470-2045(18)30742-3"}]},{"id":"nct07071961","kind":"trial","name":"Regorafenib (Reg) and Lorigerlimab (Lor), RELO Regimen, in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Di","aka":["ReLOAD"],"tldr":"A phase 2 trial of regorafenib and lorigerlimab in colorectal cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"Regorafenib (Reg) and Lorigerlimab (Lor), RELO Regimen, in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy [ReLOAD Trial] is a phase 2, interventional study registered as NCT07071961 by M.D. Anderson Cancer Center, with a registry enrolment figure of 16 participants, started 2026-02-11 and due to reach its primary completion in 2027-05-01. Interventions recorded: Regorafenib (CT); Lorigerlimab. Conditions listed: Colorectal Cancer; Regorafenib; High Risk Patients. Primary outcome: Safety and adverse events (AEs). Colorectal eligibility wording from the registry: \"* History of hysterectomy or bilateral salpingo-oophorectomy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07071961","url":"https://clinicaltrials.gov/study/NCT07071961"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors","mrd-testing"],"targets":[],"drugs":["regorafenib","lorigerlimab"],"companies":["bayer","macrogenics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07071961","phase":"2","setting":"Regorafenib (Reg) and Lorigerlimab (Lor), RELO Regimen, in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy [ReLOAD Trial]","sponsor":"M.D. Anderson Cancer Center","started":"2026-02-11","startedType":"actual","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05963490","kind":"trial","name":"Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer","aka":["SLOT"],"tldr":"A phase 2 trial of regorafenib and toripalimab in colorectal cancer, run by Fudan University, now recruiting.","summary":"Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT05963490 by Fudan University, with a registry enrolment figure of 108 participants, started 2023-04-25 and due to reach its primary completion in 2025-04-25. Interventions recorded: Regorafenib; Toripalimab; Radiotherapy; Regorafenib. Conditions listed: Microsatellite Stable Metastatic Colorectal Cancer. Primary outcome: OS. Colorectal eligibility wording from the registry: \"Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05963490","url":"https://clinicaltrials.gov/study/NCT05963490"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","imrt-igrt","kinase-inhibitors"],"targets":[],"drugs":["regorafenib","toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05963490","phase":"2","setting":"A Prospective, Randomized, Controlled Phase II Trial of Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab as Third-line Treatment in Patients With Metastatic Colorectal Cancer","sponsor":"Fudan University","started":"2023-04-25","startedType":"actual","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05794971","kind":"trial","name":"Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases","aka":["RIDER"],"tldr":"A phase 3 trial of regorafenib in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases is a phase 3, randomised interventional study registered as NCT05794971 by Sun Yat-sen University, with a registry enrolment figure of 126 participants, started 2023-06-10 and due to reach its primary completion in 2027-03-31. Interventions recorded: Regorafenib and DIBIRI; Regorafenib. Conditions listed: Colorectal Cancer Liver Metastases; Regorafenib. Primary outcome: Overall Survival (OS). Colorectal eligibility wording from the registry: \"* Patients over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give informed consent, will be eligible\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05794971","url":"https://clinicaltrials.gov/study/NCT05794971"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["regorafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05794971","phase":"3","setting":"Regorafenib Combined With Irinotecan Drug-Eluting Beads as Third-line Treatment for Colorectal Cancer Liver Metastases: a Multicentre, Randomised Phase 3 Trial (RIDER)","sponsor":"Sun Yat-sen University","started":"2023-06-10","startedType":"estimated","enrolled":126,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06425133","kind":"trial","name":"Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers","aka":["CARE"],"tldr":"A phase 2 trial of regorafenib in colorectal cancer, run by Centre Hospitalier Universitaire de Besancon, now recruiting.","summary":"Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers is a phase 2, randomised interventional study registered as NCT06425133 by Centre Hospitalier Universitaire de Besancon, with a registry enrolment figure of 174 participants, started 2024-07-19 and due to reach its primary completion in 2027-09. Interventions recorded: Blood sample; Quality of life questionnaires; Biopsy; Regorafenib; Regorafenib + metronomic chemotherapy. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: To evaluate the impact of a Regorafenib combined with metronomic chemotherapy and low-dose aspirin compared to standard Regorafenib treatment by assessing progression-free survival. Colorectal eligibility wording from the registry: \"Patients with histologically proven metastatic colorectal cancer in progression after previous standard treatments (5FU, CPT11 (Irinotecan), oxaliplatin, anti-VEGF (vascular endothelial growth factor), trifluridine/tipiracil, anti-EGFR (epidermal growth factor receptor) therapy if KRAS (Kirsten rat \". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06425133","url":"https://clinicaltrials.gov/study/NCT06425133"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal","braf-v600e-colorectal"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["regorafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06425133","phase":"2","setting":"Impact of Regorafenib in Combination With Multimodal Metronomic Chemotherapy on Progression-free Survival Compared With Standard Regorafenib for the Treatment of Chemo-resistant Metastatic Colorectal Cancers","sponsor":"Centre Hospitalier Universitaire de Besancon","started":"2024-07-19","startedType":"actual","enrolled":174,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05462613","kind":"trial","name":"Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer","aka":["REPROGRAM-02"],"tldr":"A phase 2/3 trial of regorafenib, aspirin and bevacizumab (glioblastoma use) in colorectal cancer, run by Centre Hospitalier Universitaire de Besancon, now recruiting.","summary":"Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer is a phase 2/3, randomised interventional study registered as NCT05462613 by Centre Hospitalier Universitaire de Besancon, with a registry enrolment figure of 446 participants, started 2023-05-09 and due to reach its primary completion in 2029-11. Interventions recorded: quality of life questionnaires; Blood sample; Regorafenib; Metronomic chemotherapies; Aspirin; Bevacizumab; FOLFIRI or FOLFOX. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: best objective response during treatment period (phase II); overall survival (OS) (phase III). Colorectal eligibility wording from the registry: \"Patients with histologically proven metastatic colorectal cancer in progression after a first line of chemotherapy +/- targeted therapy\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05462613","url":"https://clinicaltrials.gov/study/NCT05462613"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["regorafenib","aspirin","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05462613","phase":"2/3","setting":"Induction Regorafenib in Combination With Metronomic Cyclophosphamide, Capecitabine, and Low-dose Aspirin Followed by Chemotherapy in Second Line Metastatic Colorectal Cancer Carcinoma An Open-label Randomized Phase II-III Study","sponsor":"Centre Hospitalier Universitaire de Besancon","started":"2023-05-09","startedType":"actual","enrolled":446,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06756074","kind":"trial","name":"Reinforced Pancreaticojejunostomy With or Without glubran2","aka":["Glubran 2"],"tldr":"A phase 2 trial in pancreatic cancer, run by Minia University, now recruiting.","summary":"Reinforced Pancreaticojejunostomy With or Without glubran2 is a phase 2, randomised interventional study registered as NCT06756074 by Minia University, with a registry enrolment figure of 100 participants, started 2025-01-15 and due to reach its primary completion in 2026-04-15. Interventions recorded: Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2); Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2). Conditions listed: Pancreatic Fistula; Pancreas Cancer; Periampullary Carcinoma; Pancreatic Ductal Adenocarcinoma. Primary outcome: the rate of Postoperative pancreatic fistula within 2 weeks after operation. Pancreatic eligibility wording from the registry: \"* All the patients undergoing pancreaticoduodenectomy for cancer\". Sites: Egypt. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06756074","url":"https://clinicaltrials.gov/study/NCT06756074"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06756074","phase":"2","setting":"Impact of Reinforced Pancreaticojejunostomy With or Without Tissue Adhesive Glue Modified Cyanoacrylate (Glubran 2) Following Pancreaticoduodenectomy, Randomized Controlled Clinical Trial.","sponsor":"Minia University","started":"2025-01-15","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05491226","kind":"trial","name":"Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation","aka":[],"tldr":"A phase 2 trial of pembrolizumab in triple-negative breast cancer, run by Stephen Shiao, now recruiting.","summary":"Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation is a phase 2, interventional study registered as NCT05491226 by Stephen Shiao, with a registry enrolment figure of 35 participants, started 2023-11-17 and due to reach its primary completion in 2026-12-01. Interventions recorded: Pembrolizumab; Radiation Therapy; Axatilimab. Conditions listed: TNBC - Triple-Negative Breast Cancer; Breast Cancer. Triple-negative eligibility wording from the registry: \"* Female patients diagnosed with high-risk triple negative breast cancer (TNBC) with intent for neoadjuvant therapy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05491226","url":"https://clinicaltrials.gov/study/NCT05491226"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05491226","phase":"2","setting":"IIT2021-01-Shiao-CSF1Ri: Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation","sponsor":"Stephen Shiao","started":"2023-11-17","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"rejoice-ovarian01","kind":"trial","name":"REJOICE-Ovarian01","aka":[],"tldr":"Tests whether a CDH6-targeting ADC with Enhertu's payload can beat chemotherapy in resistant ovarian cancer.","summary":"REJOICE-Ovarian01, trial NCT06161025 sponsored by Daiichi Sankyo and Merck, is the phase 2/3 test of whether raludotatug deruxtecan, a CDH6-targeting antibody-drug conjugate carrying the same payload as trastuzumab deruxtecan, can beat physician's choice chemotherapy in platinum-resistant ovarian cancer after one to three prior lines. The phase 2 dose-optimisation part reported an objective response rate of 50.5 percent at ESMO 2025, the phase 3 part randomises at 5.6 mg/kg against chemotherapy, and readout is expected in 2026 to 2027. OnCo links it to ovarian cancer, antibody-drug conjugates, CDH6 as a target and raludotatug deruxtecan. Whether a new ADC target can match mirvetuximab's survival benefit, and in which patients, is the question it will answer.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06161025","url":"https://clinicaltrials.gov/study/NCT06161025"}],"tags":[],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["adc"],"targets":["cdh6"],"drugs":["raludotatug-deruxtecan"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06161025","phase":"2/3","setting":"Platinum-resistant ovarian cancer, 1-3 prior lines: raludotatug deruxtecan (CDH6 ADC) vs physician's-choice chemotherapy","sponsor":"Daiichi Sankyo / Merck","result":"Phase 2 ORR 50.5%; phase 3 ongoing.","started":"2024-02-27","startedType":"actual","enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (phase 2 part)","unit":"%","arms":[{"name":"R-DXd","value":50.5}],"source":"https://www.merck.com/news/raludotatug-deruxtecan-demonstrated-clinically-meaningful-response-rates-in-patients-with-recurrent-platinum-resistant-ovarian-primary-peritoneal-or-fallopian-tube-cancer-in-phase-2-part-of-rejoice-o/"}]},{"id":"nct06906341","kind":"trial","name":"Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers","aka":["BELLA"],"tldr":"A phase 2 trial of Relacorilant and Bevacizumab in ovarian cancer and endometrial cancer, run by Corcept Therapeutics, now recruiting.","summary":"Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers is a phase 2 interventional study registered as NCT06906341 by Corcept Therapeutics, with 270 participants planned, started 2025-04-11 and due to reach its primary completion in 2026-08. Interventions recorded: Relacorilant 150 mg once daily (QD), Nab-paclitaxel 80 mg/m^2 and Bevacizumab 10 mg/kg.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06906341","url":"https://clinicaltrials.gov/study/NCT06906341"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","endometrial"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["relacorilant","bevacizumab"],"companies":["corcept"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06906341","phase":"2","setting":"An Open-label, Global, Multi-Arm Study to Evaluate the Efficacy and Safety of Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers (BELLA)","sponsor":"Corcept Therapeutics","started":"2025-04-11","startedType":"actual","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07259317","kind":"trial","name":"Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma","aka":["TRIDENT"],"tldr":"A phase 2 trial of Relacorilant and Gemcitabine in pancreatic ductal adenocarcinoma, run by Corcept Therapeutics, now recruiting.","summary":"Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma is a phase 2 interventional study registered as NCT07259317 by Corcept Therapeutics, with 80 participants planned, started 2026-01-27 and due to reach its primary completion in 2027-09. Interventions recorded: Relacorilant, Nab-paclitaxel and Gemcitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07259317","url":"https://clinicaltrials.gov/study/NCT07259317"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["relacorilant","gemcitabine"],"companies":["corcept"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07259317","phase":"2","setting":"A Phase 2, Single-Arm Trial of Relacorilant in Combination With Nab-Paclitaxel and Gemcitabine in Chemotherapy-Naïve Patients With Metastatic Pancreatic Adenocarcinoma (TRIDENT)","sponsor":"Corcept Therapeutics","started":"2026-01-27","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"relativity-047","kind":"trial","name":"RELATIVITY-047","aka":[],"tldr":"Proved that adding a LAG-3 blocker to PD-1 blockade delays progression, with far less toxicity than the ipilimumab combination.","summary":"PFS 10.1 vs 4.6 months (HR 0.75) led to FDA approval of Opdualag in March 2022. OS was not formally significant at first analysis; extended follow-up reported median OS 51.0 vs 34.1 months with 3-year OS 54.6% vs 48.0% (JCO 2024) and a 4-year update (EJC 2025) with the upper confidence bound below 1. Grade 3-4 treatment-related events ~21% versus ~59% for nivolumab-ipilimumab in CheckMate 067.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03470922","url":"https://clinicaltrials.gov/study/NCT03470922"},{"label":"3-year OS, JCO 2024","url":"https://ascopubs.org/doi/10.1200/JCO.24.01124"},{"label":"4-year update, EJC 2025","url":"https://www.ejcancer.com/article/S0959-8049(25)00329-6/fulltext"}],"tags":[],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["lag3","pd1"],"drugs":["relatlimab-nivolumab","nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["checkmate-067"],"people":["hussein-tawbi"],"bottlenecks":[],"keyPapers":["paper-relativity-047-nejm-2022","paper-relativity-047-nejm-evid-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03470922","phase":"2/3","setting":"Untreated unresectable or metastatic melanoma: nivolumab + relatlimab (fixed dose) vs nivolumab","sponsor":"BMS","result":"PFS HR 0.75; median OS 51.0 vs 34.1 months.","started":"2018-04-11","startedType":"actual","yearReported":2022,"enrolled":714,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab + relatlimab","value":10.1},{"name":"Nivolumab","value":4.6}],"hr":0.75,"source":"https://ascopubs.org/doi/10.1200/JCO.24.01124"},{"endpoint":"Overall survival (3-year)","unit":"%","arms":[{"name":"Nivolumab + relatlimab","value":54.6},{"name":"Nivolumab","value":48}],"source":"https://ascopubs.org/doi/10.1200/JCO.24.01124"}],"replication":"No independent phase 3 yet; the adjuvant RELATIVITY-098 trial of the same combination was negative, so the benefit appears specific to the advanced setting."},{"id":"relativity-098","kind":"trial","name":"RELATIVITY-098","aka":[],"tldr":"Adding relatlimab to adjuvant nivolumab did not reduce recurrence, so the LAG-3 combination stays a treatment for measurable disease.","summary":"RELATIVITY-098, trial NCT05002569 sponsored by Bristol Myers Squibb and published in 2025, found that adding the LAG-3 antibody relatlimab to adjuvant nivolumab did not reduce recurrence in resected stage III and IV melanoma, so the combination stays a treatment for measurable disease. It randomised 1,093 patients and showed no difference in recurrence-free survival, with overall survival not formally tested. OnCo links it to LAG-3 as a target, the relatlimab plus nivolumab and nivolumab records, Hussein A. Tawbi and a caution pairing about LAG-3 blockade outside active disease. Whether LAG-3 blockade needs an antigen-rich tumour to act on, echoing why neoadjuvant designs outperform adjuvant ones, is the question it raises.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05002569","url":"https://clinicaltrials.gov/study/NCT05002569"},{"label":"RELATIVITY-098 publication","url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12705465/"}],"tags":["failure","lesson:adjuvant-vs-active-disease"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["lag3"],"drugs":["relatlimab-nivolumab","nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["hussein-tawbi"],"bottlenecks":[],"keyPapers":["paper-relativity-098-nat-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05002569","phase":"3","setting":"Resected stage III/IV melanoma: adjuvant nivolumab + relatlimab vs nivolumab","sponsor":"BMS","result":"RFS not improved.","started":"2021-10-19","startedType":"actual","yearReported":2025,"enrolled":1093,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab + relatlimab","n":547,"note":"No difference; OS not formally tested"},{"name":"Nivolumab","n":546}],"hr":1.01,"ci":[0.83,1.22],"p":"0.928","source":"https://doi.org/10.1038/s41591-025-04032-8"}],"replication":"Failed to extend the RELATIVITY-047 advanced-disease benefit into the adjuvant setting; translational data attribute this to low peripheral LAG-3+ T cells without macroscopic tumour."},{"id":"relevance","kind":"trial","name":"RELEVANCE","aka":["RV-FOL-GELARC-0683C"],"tldr":"RELEVANCE tested whether a chemotherapy-free combination of rituximab and the pill lenalidomide could beat standard chemo-immunotherapy for untreated follicular lymphoma; it was not better, but it was just as effective with a different set of side effects, so it became an accepted alternative.","summary":"RELEVANCE was an open-label phase 3 superiority trial run by Celgene with the French LYSA group that randomised 1,030 patients with previously untreated follicular lymphoma to rituximab plus lenalidomide or rituximab plus chemotherapy (R-CHOP in most), each followed by rituximab maintenance. The co-primary endpoints were confirmed or unconfirmed complete response at 120 weeks by independent review and progression-free survival.\n\nComplete response at 120 weeks was 48 percent with rituximab-lenalidomide against 53 percent with rituximab-chemotherapy, and interim three-year progression-free survival was 77 against 78 percent, so superiority was not shown. In the final registry results median progression-free survival was 120.2 against 123.8 months (hazard ratio 0.92). Grade 3 or 4 neutropenia and febrile neutropenia were more common with chemotherapy and grade 3 or 4 skin reactions with lenalidomide. The corpus's follicular lymphoma page lists lenalidomide-rituximab as an alternative first-line option on this evidence.","status":"mixed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01476787","url":"https://clinicaltrials.gov/study/NCT01476787"}],"tags":["soc-trials"],"related":["lymphoma-roadmap","prima-follicular","lymphoma-ev-fixed-duration-chemotherapy-free-first-line"],"cancers":["follicular-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["lenalidomide","rituximab","bendamustine","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-relevance-rituximab-lenalidomide-follicular-lymphoma-morschhauser-nejm-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01476787","phase":"3","setting":"Previously untreated advanced follicular lymphoma needing treatment: rituximab plus lenalidomide (R2) against rituximab plus the investigator's chemotherapy (R-CHOP, R-CVP or R-bendamustine), both followed by rituximab maintenance, with complete response at 120 weeks and progression-free survival as co-primary endpoints","sponsor":"Celgene","result":"Complete response at 120 weeks 48 percent with rituximab-lenalidomide against 53 percent with rituximab-chemotherapy (p 0.13) and median progression-free survival 120.2 against 123.8 months (hazard ratio 0.92): not superior, with similar efficacy and a different safety profile.","started":"2011-12-29","startedType":"actual","yearReported":2018,"enrolled":1030,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete or unconfirmed complete response at 120 weeks (independent review)","primary":true,"unit":"%","arms":[{"name":"Rituximab + lenalidomide","n":513,"value":48,"note":"95% CI 44 to 53"},{"name":"Rituximab + chemotherapy","n":517,"value":53,"note":"95% CI 49 to 57"}],"p":"0.13","source":"https://doi.org/10.1056/NEJMoa1805104"},{"endpoint":"Progression-free survival at 3 years (interim)","primary":true,"unit":"%","arms":[{"name":"Rituximab + lenalidomide","n":513,"value":77,"note":"95% CI 72 to 80"},{"name":"Rituximab + chemotherapy","n":517,"value":78,"note":"95% CI 74 to 82"}],"source":"https://doi.org/10.1056/NEJMoa1805104"},{"endpoint":"Progression-free survival, final (registry results)","primary":true,"unit":"months","arms":[{"name":"Rituximab + lenalidomide","value":120.2,"note":"95% CI 104.9 to 126.3"},{"name":"Rituximab + chemotherapy","value":123.8,"note":"95% CI 107.4 to not reached"}],"hr":0.92,"ci":[0.756,1.12],"p":"0.406","source":"https://clinicaltrials.gov/study/NCT01476787?tab=results"},{"endpoint":"Grade 3 or 4 neutropenia","unit":"%","arms":[{"name":"Rituximab + lenalidomide","value":32},{"name":"Rituximab + chemotherapy","value":50}],"source":"https://doi.org/10.1056/NEJMoa1805104"},{"endpoint":"Grade 3 or 4 cutaneous reactions","unit":"%","arms":[{"name":"Rituximab + lenalidomide","value":7},{"name":"Rituximab + chemotherapy","value":1}],"source":"https://doi.org/10.1056/NEJMoa1805104"}]},{"id":"reliance","kind":"trial","name":"RELIANCE","aka":[],"tldr":"The trial that made relma-cel the first CAR-T developed and manufactured in China to be approved, with three quarters of patients responding.","summary":"59 patients treated (Cancer Medicine 2021): objective response 75.9%, complete response 51.7%, with grade 3 or higher cytokine release syndrome in about 5% and neurotoxicity in about 3%, a favourable profile consistent with the 4-1BB construct shared with lisocabtagene maraleucel. Basis of NMPA approval in September 2021.","status":"positive","asOf":"2026-09-10","links":[{"label":"Cancer Med 2021","url":"https://doi.org/10.1002/cam4.3686"}],"tags":["china"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["car-t"],"targets":["cd19"],"drugs":["relmacabtagene-autoleucel"],"companies":["jw-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-ying-cancer-med"],"journals":[],"dependsOn":[],"notes":[],"phase":"2","setting":"Relapsed or refractory large B-cell lymphoma after two or more lines, China: single-arm pivotal study of relmacabtagene autoleucel at two dose levels","sponsor":"JW Therapeutics","result":"ORR 75.9%, CR 51.7%.","yearReported":2021,"enrolled":59,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Relma-cel (both dose levels)","n":59,"value":75.9}],"source":"https://doi.org/10.1002/cam4.3686"}]},{"id":"nct06093841","kind":"trial","name":"Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL","aka":[],"tldr":"A phase 2 trial of Relmacabtagene autoleucel, Fludarabine, Cyclophosphamide in follicular lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd., active and no longer recruiting.","summary":"Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL is a phase 2 interventional study registered as NCT06093841 by Shanghai Ming Ju Biotechnology Co., Ltd., with 46 participants planned, started 2023-11-03 and due to reach its primary completion in 2024-01-21. Interventions recorded: Relmacabtagene Autoleucel, Fludarabine, Cyclophosphamide. Conditions listed: Lymphoma, Large B-Cell, Diffuse, Follicular Lymphoma Grade 3B, High-grade B-cell Lymphoma, Mediastinal B-Cell Diffuse Large Cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06093841","url":"https://clinicaltrials.gov/study/NCT06093841"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["relmacabtagene-autoleucel","fludarabine","cyclophosphamide"],"companies":["jw-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06093841","phase":"2","setting":"Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL: a Single-arm, Multicenter, Open, Phase II Study","sponsor":"Shanghai Ming Ju Biotechnology Co., Ltd.","started":"2023-11-03","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"remarc","kind":"trial","name":"REMARC","aka":["Lenalidomide maintenance in elderly diffuse large B-cell lymphoma","REMARC trial"],"tldr":"Two years of a tablet taken after chemotherapy delayed relapse in older people with aggressive lymphoma but did not help them live longer, and caused low white cell counts in over half.","summary":"REMARC randomised 650 people aged 60 to 80 who had reached a complete or partial response after first-line R-CHOP to lenalidomide 25 mg daily for 21 of every 28 days for 24 months, or placebo.\n\nAt the primary analysis, with a median follow-up of 39 months from randomisation, median progression-free survival was not reached with lenalidomide against 58.9 months with placebo, a hazard ratio of 0.708 (95 per cent confidence interval 0.537 to 0.933, p = 0.01). The effect was consistent by sex, by age-adjusted International Prognostic Index, by response quality and by positron emission tomography status at randomisation. With longer follow-up of 52 months, overall survival was no different (hazard ratio 1.218, 0.861 to 1.721, p = 0.26). Grade 3 or 4 neutropenia occurred in 56 per cent on lenalidomide against 22 per cent on placebo, and cutaneous reactions in 5 against 1 per cent.\n\nREMARC is the clearest example in aggressive lymphoma of a maintenance strategy that delays progression without extending life, and of why that distinction is worth explaining to a patient weighing two years of tablets and blood counts. Lenalidomide maintenance did not become a standard of care on this result.","status":"mixed","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT01122472","url":"https://clinicaltrials.gov/study/NCT01122472"},{"label":"Journal of Clinical Oncology 2017","url":"https://doi.org/10.1200/JCO.2017.72.6984"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["dlbcl","non-hodgkin-lymphoma"],"sections":["immunotherapy","chemotherapy"],"technologies":[],"targets":[],"drugs":["lenalidomide","rituximab"],"companies":["lysa"],"institutions":[],"pathways":[],"terms":["maintenance-therapy","lymphoma-tx-maintenance","r-chop","ipi-score"],"trials":[],"people":["catherine-thieblemont","gilles-salles"],"bottlenecks":["b-toxicity-qol","b-aging-comorbidity"],"keyPapers":["paper-remarc-lenalidomide-maintenance-dlbcl-jco-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01122472","phase":"3","setting":"Aged 60 to 80, in complete or partial response after six or eight cycles of R-CHOP: two years of lenalidomide maintenance against placebo","sponsor":"The Lymphoma Academic Research Organisation","result":"Progression-free survival hazard ratio 0.708 (p = 0.01); overall survival unchanged (hazard ratio 1.218, p = 0.26), with grade 3 or 4 neutropenia in 56 per cent.","started":"2009-04","yearReported":2017,"enrolled":650,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Lenalidomide maintenance","note":"median not reached"},{"name":"Placebo","value":58.9}],"hr":0.708,"ci":[0.537,0.933],"p":"0.01","source":"https://doi.org/10.1200/JCO.2017.72.6984"},{"endpoint":"Overall survival","arms":[{"name":"Lenalidomide maintenance"},{"name":"Placebo"}],"hr":1.218,"ci":[0.861,1.721],"p":"0.26"}],"replication":"Not replicated; the contemporaneous first-line lenalidomide combinations took a different route."},{"id":"nct05796375","kind":"trial","name":"Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance","aka":[],"tldr":"A phase 2 trial of Bladder EpiCheck urine methylation test in Non-muscle-invasive bladder cancer, run by White River Junction Veterans Affairs Medical Center, now recruiting.","summary":"Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance is a phase 2 interventional study registered as NCT05796375 by White River Junction Veterans Affairs Medical Center, with 240 participants planned, started 2023-11-17 and due to reach its primary completion in 2028-11-30. Interventions recorded: Cystoscopy, Bladder EpiCheck urine test, Xpert Bladder Cancer Monitor urine test. Conditions recorded: Non-muscle-invasive Bladder Cancer.\n\nLinked to the technology Bladder EpiCheck urine methylation test because the registry names it (\"epicheck\") among its interventions and Non-muscle-invasive bladder cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05796375","url":"https://clinicaltrials.gov/study/NCT05796375"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["bladder-epicheck"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05796375","phase":"2","setting":"Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance","sponsor":"White River Junction Veterans Affairs Medical Center","started":"2023-11-17","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06315010","kind":"trial","name":"Repotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain Metastasis","aka":["REPOSE"],"tldr":"A phase 2 trial of repotrectinib in lung cancer, run by MedSIR, now recruiting.","summary":"Repotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain Metastasis is a phase 2, interventional study registered as NCT06315010 by MedSIR, with a registry enrolment figure of 20 participants, started 2025-06-27 and due to reach its primary completion in 2027-03. Interventions recorded: Repotrectinib. Conditions listed: NSCLC; Brain Metastases; ROS1 Gene Rearrangement. Primary outcome: Intracranial Objective Response Rate (IC-ORR). Lung eligibility wording from the registry: \"Histologically documented NSCLC\". Sites: Austria, Germany, Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06315010","url":"https://clinicaltrials.gov/study/NCT06315010"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["ros1-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["repotrectinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06315010","phase":"2","setting":"A Phase II Study Assessing Safety and Efficacy of Repotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain Metastasis (The REPOSE Study)","sponsor":"MedSIR","started":"2025-06-27","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06580002","kind":"trial","name":"Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by University of California, Irvine, now recruiting.","summary":"Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial is a phase 2, randomised interventional study registered as NCT06580002 by University of California, Irvine, with a registry enrolment figure of 75 participants, started 2024-12-02 and due to reach its primary completion in 2027-07. Interventions recorded: Riluzole; Placebo. Conditions listed: Breast Cancer; Sarcoma; Gastric Cancer; Lung Cancer; Head and Neck Cancer; Colorectal Cancer; Ovarian Cancer; Liver Cancer; Genitourinary Cancer; Gynecologic Cancer; Urinary Bladder Cancer; Leukemia; Lymphoid Leukemia; Myeloma Multiple; Prostate Cancer; Pancreas Cancer; Non-hodgkin Lymphoma; Hodgkin Lymphoma; Brain Cancer; Melanoma; Mycosis Fungoides; Kidney Cancer. Primary outcome: Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer survivors experiencing cognitive impairment (CRCI). Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06580002","url":"https://clinicaltrials.gov/study/NCT06580002"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06580002","phase":"2","setting":"Repurposing Riluzole for Augmenting Brain-Derived Neuropathic Factor (BDNF) Levels and Cognitive Function in Patients Experiencing Cancer-Related Cognitive Impairment: An Interventional Pilot Clinical Trial","sponsor":"University of California, Irvine","started":"2024-12-02","startedType":"actual","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01037478","kind":"trial","name":"Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma","aka":[],"tldr":"A phase 2 trial of Resminostat in Hodgkin lymphoma, run by 4SC AG, completed.","summary":"Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma is a phase 2 interventional study registered as NCT01037478 by 4SC AG, with 37 participants recorded, started 2009-12 and reaching its primary completion in 2012-01. Interventions recorded: Resminostat (4SC-201). Conditions recorded: Hodgkin's Lymphoma.\n\nLinked to the drug Resminostat because the registry names it among its interventions and Hodgkin lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01037478","url":"https://clinicaltrials.gov/study/NCT01037478"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","relapsed-refractory-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["resminostat"],"companies":["4sc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01037478","phase":"2","setting":"A Phase 2 Proof of Concept Study to Evaluate the Efficacy, Safety and Pharmacokinetics of the HDAC Inhibitor 4SC-201 in Patients With Relapsed or Refractory Hodgkin's Lymphoma","sponsor":"4SC AG","started":"2009-12","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02953301","kind":"trial","name":"Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)","aka":[],"tldr":"A phase 2 trial of Resminostat in Cutaneous T-cell lymphoma and Peripheral T-cell lymphomas, run by 4SC AG, completed.","summary":"Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS) is a phase 2 interventional study registered as NCT02953301 by 4SC AG, with 201 participants recorded, started 2016-11 and reaching its primary completion in 2023-03. Interventions recorded: resminostat, Placebo. Conditions recorded: Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous.\n\nLinked to the drug Resminostat because the registry names it among its interventions and Cutaneous T-cell lymphoma and Peripheral T-cell lymphomas among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02953301","url":"https://clinicaltrials.gov/study/NCT02953301"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cutaneous-t-cell-lymphoma","peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["resminostat"],"companies":["4sc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02953301","phase":"2","setting":"A Multicentre, Double Blind, Randomised, Placebo-controlled, Phase II Trial to Evaluate Resminostat for Maintenance Treatment of Patients With Advanced Stage (Stage IIB-IVB) Mycosis Fungoides (MF) or Sézary Syndrome (SS) That Have Achieved Disease Control With Systemic Therapy - the RESMAIN Study","sponsor":"4SC AG","started":"2016-11","startedType":"actual","enrolled":201,"enrolledBasis":"registry","outcomes":[]},{"id":"resolve","kind":"trial","name":"RESOLVE","aka":["RESOLVE ibrutinib pancreatic"],"tldr":"RESOLVE tested the leukaemia drug ibrutinib as a way to reprogramme the immune cells around pancreatic tumours; added to nab-paclitaxel and gemcitabine it shortened the time to progression and cut the chemotherapy patients could tolerate, with no survival gain.","summary":"RESOLVE randomised 424 patients (211 ibrutinib, 213 placebo). After a median follow-up of 25 months, median overall survival was 9.7 against 10.8 months (p 0.3225), progression-free survival was shorter with ibrutinib (5.3 against 6.0 months; p below 0.0001) and response lower (29 against 42 percent; p 0.0058); patients on ibrutinib spent less time on treatment and received lower cumulative doses of every agent. Grade 3 or worse neutropenia was 24 against 35 percent, peripheral sensory neuropathy 17 against 8 percent and anaemia 16 against 17 percent. Seven UK sites took part (Derriford Plymouth, Broomfield Chelmsford, the Christie, Southampton, Clatterbridge, the Royal Marsden Sutton and the Royal Free). The registry figure of 430 exceeds the 424 randomised in the paper by six.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02436668","url":"https://clinicaltrials.gov/study/NCT02436668"},{"label":"Tempero et al., RESOLVE (Annals of Oncology 2021)","url":"https://doi.org/10.1016/j.annonc.2021.01.070"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors"],"targets":["btk"],"drugs":["ibrutinib","gemcitabine-nab-paclitaxel"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":["pancreatic-failed-programmes"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 7): Derriford Hospital Plymouth; Broomfield Hospital Chelmsford; The Christie Manchester; Southampton General; Clatterbridge Cancer Centre; Royal Marsden Sutton; Royal Free London."],"nct":"NCT02436668","phase":"3","setting":"Untreated metastatic pancreatic ductal adenocarcinoma at sites in eight countries: ibrutinib 560 mg daily or placebo with nab-paclitaxel plus gemcitabine, double-blind, with overall survival and investigator-assessed progression-free survival as primary endpoints","sponsor":"Pharmacyclics (AbbVie)","result":"Median overall survival 9.7 months with ibrutinib plus nab-paclitaxel and gemcitabine against 10.8 months with placebo (p 0.3225); progression-free survival 5.3 against 6.0 months (p below 0.0001); response 29 against 42 percent.","started":"2015-05","yearReported":2021,"enrolled":430,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Ibrutinib + nab-paclitaxel + gemcitabine","n":211,"value":9.7},{"name":"Placebo + nab-paclitaxel + gemcitabine","n":213,"value":10.8}],"p":"0.3225","source":"https://doi.org/10.1016/j.annonc.2021.01.070"},{"endpoint":"Progression-free survival (investigator)","primary":true,"unit":"months","arms":[{"name":"Ibrutinib + nab-paclitaxel + gemcitabine","n":211,"value":5.3},{"name":"Placebo + nab-paclitaxel + gemcitabine","n":213,"value":6}],"p":"<0.0001","source":"https://doi.org/10.1016/j.annonc.2021.01.070"}]},{"id":"resonate","kind":"trial","name":"RESONATE","aka":[],"tldr":"The trial that made a daily pill the standard for relapsed CLL, cutting the risk of progression by nearly 80%.","summary":"RESONATE, trial NCT01578707 sponsored by Pharmacyclics and Janssen and published in the New England Journal of Medicine in 2014, is the trial that made a daily tablet the standard for relapsed chronic lymphocytic leukaemia, cutting the risk of progression by nearly eighty percent. It randomised 391 patients with relapsed or refractory CLL to ibrutinib or ofatumumab, met its primary progression-free survival endpoint at the interim analysis with a survival benefit as well, and the six-year follow-up showed the advantage maintained including in del(17p) and unmutated IGHV disease, the basis of the 2014 CLL approval. OnCo links it to chronic lymphocytic leukaemia, BTK as a target, ibrutinib, John C. Byrd and The Ohio State University cancer centre. Whether continuous therapy or fixed-duration combinations serve patients better is the question the field has moved on to.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01578707","url":"https://clinicaltrials.gov/study/NCT01578707"}],"tags":[],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["btk"],"drugs":["ibrutinib","ofatumumab"],"companies":["abbvie","johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["john-byrd"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01578707","phase":"3","setting":"Relapsed or refractory CLL/SLL: ibrutinib vs ofatumumab","sponsor":"Pharmacyclics / Janssen","result":"PFS HR 0.22; median PFS 44.1 vs 8.1 months (6-year).","started":"2012-06","startedType":"actual","yearReported":2014,"enrolled":391,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"arms":[{"name":"Ibrutinib","n":195},{"name":"Ofatumumab","n":196}],"hr":0.22,"ci":[0.15,0.32],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1400376"},{"endpoint":"Progression-free survival (median, 6-year follow-up)","unit":"months","arms":[{"name":"Ibrutinib","value":44.1},{"name":"Ofatumumab","value":8.1}],"source":"https://doi.org/10.1056/NEJMoa1400376"}],"replication":"RESONATE-2 (frontline vs chlorambucil), HELIOS, and the Alliance A041202 trial all confirmed BTK-inhibitor superiority over chemoimmunotherapy in CLL."},{"id":"resonate-2","kind":"trial","name":"RESONATE-2","aka":[],"tldr":"RESONATE-2 showed that the oral BTK inhibitor ibrutinib kept untreated chronic lymphocytic leukaemia in check far longer than the old chemotherapy tablet chlorambucil in older patients, and helped them live longer, which brought targeted pills into first-line treatment of this leukaemia.","summary":"RESONATE-2 was an open-label phase 3 trial in patients aged 65 or older with previously untreated chronic lymphocytic leukaemia or small lymphocytic lymphoma, excluding those with 17p deletion. Patients were randomised to continuous ibrutinib or to chlorambucil, the chemotherapy standard for older patients at the time.\n\nIbrutinib significantly prolonged progression-free survival, the primary endpoint assessed by an independent review committee, and improved overall survival and response rates. The result led to approval of ibrutinib for first-line CLL in the United States in March 2016 and made continuous BTK inhibition a standard first treatment; long-term follow-up has confirmed durable disease control. Later trials (ELEVATE-TN, SEQUOIA) extended the approach to second-generation inhibitors.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01722487","url":"https://clinicaltrials.gov/study/NCT01722487"}],"tags":["subtype-trials"],"related":[],"cancers":["cll-treatment-naive","cll"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ibrutinib","chlorambucil"],"companies":["abbvie","johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jan-burger"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01722487","phase":"3","setting":"Previously untreated chronic lymphocytic leukaemia or small lymphocytic lymphoma in patients aged 65 or older without 17p deletion: ibrutinib until progression against chlorambucil for up to twelve cycles","sponsor":"Pharmacyclics","result":"Ibrutinib improved progression-free and overall survival over chlorambucil in older patients with untreated CLL; approved for first-line CLL in March 2016.","started":"2013-03","yearReported":2015,"enrolled":269,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (independent review committee)","primary":true,"unit":"months","arms":[{"name":"Ibrutinib","note":"Not reached; median follow-up 18.4 months; 269 randomised"},{"name":"Chlorambucil","value":18.9}],"hr":0.16,"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1509388"},{"endpoint":"Overall survival at 24 months","unit":"%","arms":[{"name":"Ibrutinib","value":98},{"name":"Chlorambucil","value":85}],"hr":0.16,"p":"0.001","source":"https://doi.org/10.1056/nejmoa1509388"},{"endpoint":"Overall response rate","unit":"%","arms":[{"name":"Ibrutinib","value":86},{"name":"Chlorambucil","value":35}],"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1509388"}]},{"id":"resorce","kind":"trial","name":"RESORCE","aka":[],"tldr":"RESORCE delivered the first second-line survival benefit in liver cancer.","summary":"RESORCE, trial NCT01774344 sponsored by Bayer and reported in 2017, delivered the first second-line survival benefit in liver cancer, with regorafenib after progression on sorafenib. It randomised 573 patients who had tolerated sorafenib to regorafenib or placebo and met its primary overall survival endpoint, establishing sequential kinase inhibitor therapy as a strategy in hepatocellular carcinoma. OnCo links it to hepatocellular carcinoma and to the regorafenib drug record. Because entry required prior tolerance of sorafenib, and first-line treatment has since shifted to immunotherapy combinations, whether the result still applies to patients who reach regorafenib by a different route is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01774344","url":"https://clinicaltrials.gov/study/NCT01774344"}],"tags":[],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["regorafenib"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01774344","phase":"3","setting":"HCC progressing on sorafenib: regorafenib vs placebo","sponsor":"Bayer","result":"OS 10.6 vs 7.8 months, HR 0.63.","started":"2013-05-14","startedType":"actual","yearReported":2017,"enrolled":573,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Regorafenib","n":379,"value":10.6},{"name":"Placebo","n":194,"value":7.8}],"hr":0.63,"ci":[0.5,0.79],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(16)32453-9"}]},{"id":"response","kind":"trial","name":"RESPONSE","aka":[],"tldr":"RESPONSE showed that ruxolitinib controls the haematocrit and shrinks the spleen in PV patients hydroxyurea has failed, and won the first drug approval specific to that setting.","summary":"RESPONSE randomised 222 patients with PV who were resistant to or intolerant of hydroxyurea and had splenomegaly to ruxolitinib or best available therapy. At week 32 the composite primary endpoint of haematocrit control without phlebotomy plus a 35 percent or greater reduction in spleen volume was reached by 21 percent on ruxolitinib versus 1 percent on best available therapy (Vannucchi and colleagues, New England Journal of Medicine 2015); haematocrit control alone was 60 percent versus 20 percent. The FDA approved ruxolitinib for this use in December 2014.","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01243944","url":"https://clinicaltrials.gov/study/NCT01243944"},{"label":"NEJM 2015","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1409002"}],"tags":["polycythaemia-vera","mpn"],"related":[],"cancers":["polycythaemia-vera","myeloproliferative-neoplasms"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ruxolitinib","pipobroman"],"companies":["incyte","novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01243944","phase":"3","setting":"Polycythaemia vera resistant to or intolerant of hydroxyurea, with an enlarged spleen: ruxolitinib versus best available therapy","sponsor":"Incyte and Novartis","result":"Composite response at week 32: 21% vs 1%; haematocrit control 60% vs 20%.","started":"2010-10-27","startedType":"actual","yearReported":2015,"enrolled":222,"enrolledBasis":"registry","outcomes":[{"endpoint":"Haematocrit control plus 35% spleen reduction at week 32","primary":true,"unit":"%","arms":[{"name":"Ruxolitinib","n":110,"value":21},{"name":"Best available therapy","n":112,"value":1}]}]},{"id":"nct06345287","kind":"trial","name":"Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC","aka":[],"tldr":"A phase 2 trial of Adaptive radiotherapy in Head and neck squamous cell carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC is a phase 2 interventional study registered as NCT06345287 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with 133 participants planned, started 2024-01-01 and due to reach its primary completion in 2025-12-31. Interventions recorded: radical radiotherapy (60Gy), radical radiotherapy (66Gy), radical radiotherapy (70Gy), anti-PD-1 or PD-L1 antibody. Conditions recorded: Head and Neck Cancer.\n\nLinked to the technology Adaptive radiotherapy because the registry's title names it (\"adaptive radiotherapy\") and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06345287","url":"https://clinicaltrials.gov/study/NCT06345287"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","hpv-negative-head-and-neck-cancer","hpv-positive-oropharyngeal-cancer"],"sections":[],"technologies":["adaptive-radiotherapy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06345287","phase":"2","setting":"Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related Head and Neck Squamous Cell Carcinoma","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2024-01-01","startedType":"actual","enrolled":133,"enrolledBasis":"registry","outcomes":[]},{"id":"response-2","kind":"trial","name":"RESPONSE-2","aka":[],"tldr":"RESPONSE-2 extended ruxolitinib's benefit to PV patients without an enlarged spleen: three times as many reached haematocrit control.","summary":"RESPONSE-2 randomised 149 patients with hydroxyurea-resistant or intolerant PV and no palpable spleen to ruxolitinib or best available therapy. Haematocrit control at week 28, the primary endpoint, was achieved by 62 percent on ruxolitinib versus 19 percent on best available therapy (Passamonti and colleagues, Lancet Oncology 2017), with better symptom scores.","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02038036","url":"https://clinicaltrials.gov/study/NCT02038036"}],"tags":["polycythaemia-vera","mpn"],"related":[],"cancers":["polycythaemia-vera"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ruxolitinib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02038036","phase":"3","setting":"Hydroxyurea-resistant or intolerant polycythaemia vera without splenomegaly: ruxolitinib versus best available therapy","sponsor":"Novartis","result":"Haematocrit control at week 28: 62% vs 19%.","started":"2014-03-25","startedType":"actual","yearReported":2017,"enrolled":149,"enrolledBasis":"registry","outcomes":[{"endpoint":"Haematocrit control at week 28","primary":true,"unit":"%","arms":[{"name":"Ruxolitinib","n":74,"value":62},{"name":"Best available therapy","n":75,"value":19}]}]},{"id":"nct02521493","kind":"trial","name":"Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome","aka":[],"tldr":"A phase 3 trial of Asparaginase, Crisantaspase, Cytarabine, Daunorubicin, Etoposide, Mitoxantrone and Thioguanine in Acute myeloid leukaemia and Leukaemia, run by Children's Oncology Group, active and no longer recruiting.","summary":"Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome is a phase 3 interventional study registered as NCT02521493 by Children's Oncology Group, with 280 participants planned, started 2015-12-23 and due to reach its primary completion in 2024-06-30. Interventions recorded: Asparaginase, Asparaginase Erwinia chrysanthemi, Cytarabine, Daunorubicin Hydrochloride, Etoposide, Laboratory Biomarker Analysis, Mitoxantrone Hydrochloride, Thioguanine. Conditions recorded: Acute Myeloid Leukemia, Down Syndrome, Myelodysplastic Syndrome, Myeloid Leukemia Associated With Down Syndrome, Myeloproliferative Neoplasm.\n\nLinked to the drug Crisantaspase because the registry names it among its interventions and Acute myeloid leukaemia and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02521493","url":"https://clinicaltrials.gov/study/NCT02521493"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["asparaginase","crisantaspase","cytarabine","daunorubicin","etoposide","mitoxantrone","thioguanine"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02521493","phase":"3","setting":"Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome","sponsor":"Children's Oncology Group","started":"2015-12-23","startedType":"actual","yearReported":2025,"enrolled":280,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free Survival (EFS)","primary":true,"unit":"%","arms":[{"name":"Arm A (Standard Risk)","n":114,"value":89.37,"note":"95% CI 82 to 93.8; Figures from the ClinicalTrials.gov results section (first posted 2025-06-13), not from a publication"},{"name":"Arm B (High Risk)","n":41,"value":80.49,"note":"95% CI 64.8 to 89.7"}],"source":"https://clinicaltrials.gov/study/NCT02521493?tab=results"}]},{"id":"nct05632809","kind":"trial","name":"REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE)","aka":["RESCUE"],"tldr":"A phase 2 trial of durvalumab in lung cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE) is a phase 2, interventional study registered as NCT05632809 by M.D. Anderson Cancer Center, with a registry enrolment figure of 39 participants, started 2023-01-10 and due to reach its primary completion in 2027-12-31. Interventions recorded: NKTR-255; Durvalumab. Conditions listed: Lung Cancer. Primary outcome: Overall survival time distribution. Lung eligibility wording from the registry: \"Histologic diagnosis of non-small cell lung cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05632809","url":"https://clinicaltrials.gov/study/NCT05632809"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["durvalumab"],"companies":["nektar-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05632809","phase":"2","setting":"REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE)","sponsor":"M.D. Anderson Cancer Center","started":"2023-01-10","startedType":"actual","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05582538","kind":"trial","name":"Restoring Sensitivity To Immunotherapy In Advanced Triple Negative Breast Cancer Exploiting Ceralasertib Priming Followed By Combined Durvalumab/Nab-Paclitaxel","aka":["ATRiBRAVE"],"tldr":"A phase 2 trial of ceralasertib, durvalumab and nab-paclitaxel in triple-negative breast cancer, run by IFOM ETS - The AIRC Institute of Molecular Oncology, now recruiting.","summary":"Restoring Sensitivity To Immunotherapy In Advanced Triple Negative Breast Cancer Exploiting Ceralasertib Priming Followed By Combined Durvalumab/Nab-Paclitaxel is a phase 2, interventional study registered as NCT05582538 by IFOM ETS - The AIRC Institute of Molecular Oncology, with a registry enrolment figure of 37 participants, started 2022-12-15 and due to reach its primary completion in 2027-12. Interventions recorded: Ceralasertib; Durvalumab; Nab-paclitaxel. Conditions listed: Triple Negative Breast Cancer Metastatic. Triple-negative eligibility wording from the registry: \"Metastatic TNBC patients who have not received prior systemic cytotoxic therapy in the advanced setting and whose tumor have relapsed from treatment with curative intent for early disease, which must have included ICI and chemotherapy as part of radical locoregional therapy\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05582538","url":"https://clinicaltrials.gov/study/NCT05582538"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["ceralasertib","durvalumab","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05582538","phase":"2","setting":"Restoring Sensitivity To Immunotherapy In Advanced Triple Negative Breast Cancer Exploiting Ceralasertib Priming Followed By Combined Durvalumab/Nab-Paclitaxel: The ATRiBRAVE Trial","sponsor":"IFOM ETS - The AIRC Institute of Molecular Oncology","started":"2022-12-15","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07219576","kind":"trial","name":"Retifanlimab and Ruxolitinib In Solid Malignancies","aka":["PRISM"],"tldr":"A phase 1/2 trial of ruxolitinib and retifanlimab in lung cancer, run by University of California, San Diego, now recruiting.","summary":"Retifanlimab and Ruxolitinib In Solid Malignancies is a phase 1/2, interventional study registered as NCT07219576 by University of California, San Diego, with a registry enrolment figure of 40 participants, started 2026-01-08 and due to reach its primary completion in 2027-12. Interventions recorded: Ruxolitinib; Retifanlimab. Conditions listed: Non Small Cell Lung Carcinoma; Renal Cell Carcinoma. Primary outcome: Recommended phase 2 dose. Lung eligibility wording from the registry: \"Advanced or metastatic clear cell renal cell carcinoma or non-small cell lung carcinoma having progressed on prior PD-1/PD-L1 therapy (radiographic progression within 6 months of discontinuing immunotherapy; immunotherapy does not need to be the immediate line of preceding therapy)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07219576","url":"https://clinicaltrials.gov/study/NCT07219576"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ruxolitinib","retifanlimab"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07219576","phase":"1/2","setting":"PRISM: Phase 1b of Retifanlimab and Ruxolitinib In Solid Malignancies Progressing on Prior Checkpoint Inhibition","sponsor":"University of California, San Diego","started":"2026-01-08","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06679634","kind":"trial","name":"Retinoblastoma Phase II Expanded Access Clinical Trial","aka":[],"tldr":"A phase 2 trial of Topotecan in retinoblastoma, run by Targeted Therapy Technologies, LLC, now recruiting.","summary":"Retinoblastoma Phase II Expanded Access Clinical Trial is a phase 2 interventional study registered as NCT06679634 by Targeted Therapy Technologies, LLC, with 30 participants planned, started 2025-02-21 and due to reach its primary completion in 2029-11. Interventions recorded: Chemoplaque also referred to as Episcleral Topotecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06679634","url":"https://clinicaltrials.gov/study/NCT06679634"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["retinoblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["topotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06679634","phase":"2","setting":"Retinoblastoma Phase II Expanded Access Clinical Trial","sponsor":"Targeted Therapy Technologies, LLC","started":"2025-02-21","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07752550","kind":"trial","name":"Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of retlirafusp alfa, nab-paclitaxel and fluzoparib in triple-negative breast cancer, run by Harbin Medical University, not yet recruiting.","summary":"Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer is a phase 2, interventional study registered as NCT07752550 by Harbin Medical University, with a registry enrolment figure of 120 participants, started 2026-07-30 and due to reach its primary completion in 2028-07-30. Interventions recorded: Retlirafusp alfa+Nab-paclitaxel:; Retlirafusp alfa+Fluzoparib; Retlirafusp alfa+TP-AC; Retlirafusp alfa+Fluzoparib. Conditions listed: Triple-Negative Breast Cancer (TNBC). Triple-negative eligibility wording from the registry: \"Histopathologically confirmed recurrent or metastatic triple-negative breast cancer, defined as ER-negative (IHC ER-positive percentage \\<1%), PR-negative (IHC PR-positive percentage \\<1%), and HER2-negative (IHC -/+ or IHC ++ but FISH/CISH -);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07752550","url":"https://clinicaltrials.gov/study/NCT07752550"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["retlirafusp-alfa","nab-paclitaxel","fluzoparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07752550","phase":"2","setting":"Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer: An Exploratory Clinical Study","sponsor":"Harbin Medical University","started":"2026-07-30","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07814859","kind":"trial","name":"Retlirafusp Alfa Combined With Famitinib, Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Unresectable Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by The First Affiliated Hospital of Zhengzhou University, not yet recruiting.","summary":"Retlirafusp Alfa Combined With Famitinib, Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Unresectable Pancreatic Cancer is a phase 2, interventional study registered as NCT07814859 by The First Affiliated Hospital of Zhengzhou University, with a registry enrolment figure of 88 participants, started 2026-08-31 and due to reach its primary completion in 2027-08-31. Interventions recorded: Retlirafusp alfa Injection; Famitinib; AG. Conditions listed: Pancreatic Cancer. Primary outcome: Progression-Free Survival. Pancreatic eligibility wording from the registry: \"Histopathologically-confirmed diagnosis of pancreatic ductal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07814859","url":"https://clinicaltrials.gov/study/NCT07814859"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07814859","phase":"2","setting":"A Prospective, Exploratory Study of Retlirafusp Alfa Combined With Famitinib and AG-Chemotherapy as First-Line Therapy for Unresectable Pancreatic Cancer","sponsor":"The First Affiliated Hospital of Zhengzhou University","started":"2026-08-31","startedType":"estimated","enrolled":88,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07773363","kind":"trial","name":"Retlirafusp Alfa Plus Apatinib and Chemotherapy as Second-Line Treatment for Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of retlirafusp alfa and rivoceranib (apatinib) in pancreatic cancer, run by Tang-Du Hospital, not yet recruiting.","summary":"Retlirafusp Alfa Plus Apatinib and Chemotherapy as Second-Line Treatment for Pancreatic Cancer is a phase 2, interventional study registered as NCT07773363 by Tang-Du Hospital, with a registry enrolment figure of 37 participants, started 2026-08-30 and due to reach its primary completion in 2027-12-30. Interventions recorded: Retlirafusp Alfa; Apatinib; Fluoropyrimidine-Based Chemotherapy. Conditions listed: Pancreatic Cancer. Primary outcome: Progression-free survival. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07773363","url":"https://clinicaltrials.gov/study/NCT07773363"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["retlirafusp-alfa","rivoceranib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07773363","phase":"2","setting":"A Prospective, Open-Label, Single-Arm Clinical Study of Retlirafusp Alfa Combined With Apatinib and Chemotherapy as Second-Line Treatment for Locally Advanced or Metastatic Pancreatic Cancer","sponsor":"Tang-Du Hospital","started":"2026-08-30","startedType":"estimated","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07815288","kind":"trial","name":"Retlirafusp Alfa Plus Targeted Therapy and Chemotherapy for Unresectable Colorectal Liver-Limited Metastases","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Peking University Cancer Hospital & Institute, not yet recruiting.","summary":"Retlirafusp Alfa Plus Targeted Therapy and Chemotherapy for Unresectable Colorectal Liver-Limited Metastases is a phase 2, interventional study registered as NCT07815288 by Peking University Cancer Hospital & Institute, with a registry enrolment figure of 80 participants, started 2026-09-30 and due to reach its primary completion in 2029-12-30. Interventions recorded: Retlirafusp alfa Combined with Targeted Therapy and Chemotherapy. Conditions listed: Colorectal Adenocarcinoma Metastatic in the Liver. Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"Histopathologically confirmed colorectal adenocarcinoma; liver metastasis confirmed by pathology or imaging\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07815288","url":"https://clinicaltrials.gov/study/NCT07815288"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07815288","phase":"2","setting":"Retlirafusp Alfa Plus Targeted Therapy and Chemotherapy as Conversion Therapy for Initially Unresectable Colorectal Cancer Liver Metastases: An Exploratory Phase II Study","sponsor":"Peking University Cancer Hospital & Institute","started":"2026-09-30","startedType":"estimated","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"revel","kind":"trial","name":"REVEL","aka":[],"tldr":"Adding an antibody against the VEGF receptor to second-line chemotherapy added about six weeks of life: enough for a licence, not enough for NICE.","summary":"Ramucirumab is a human IgG1 antibody against the extracellular domain of VEGFR-2. REVEL screened 1,825 patients between December 2010 and January 2013 and randomised 1,253 with stage IV squamous or non-squamous disease progressing on or after first-line platinum chemotherapy to docetaxel 75 mg/m2 with ramucirumab 10 mg/kg (628) or with placebo (625), stratified by sex, region, performance status and previous maintenance therapy.\n\nMedian overall survival was 10.5 months against 9.1 months (hazard ratio 0.86, 95 percent confidence interval 0.75 to 0.98, p=0.023) and median progression-free survival 4.5 against 3.0 months (0.76, 0.68 to 0.86). Squamous histology was included, which was unusual for an anti-angiogenic drug after the pulmonary haemorrhage seen with bevacizumab in squamous disease.\n\nThe FDA approved the combination in 2014. NICE TA403 (24 August 2016) does not recommend ramucirumab with docetaxel, so it is not funded in England, and the six-week median gain is why. Ramucirumab reappeared in lung cancer in the Lung-MAP substudy S1800A, where it was combined with pembrolizumab after progression on immunotherapy.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01168973","url":"https://clinicaltrials.gov/study/NCT01168973"},{"label":"REVEL (Lancet 2014)","url":"https://doi.org/10.1016/S0140-6736(14)60845-X"},{"label":"NICE TA403: ramucirumab for previously treated non-small-cell lung cancer (not recommended)","url":"https://www.nice.org.uk/guidance/ta403"}],"tags":[],"related":[],"cancers":["nsclc","lung-squamous-cell-carcinoma","lung-adenocarcinoma"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody","cytotoxic-chemotherapy"],"targets":["vegf"],"drugs":["ramucirumab","docetaxel"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":["lume-lung-1","lung-map-s1800a"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01168973","phase":"3","setting":"Stage IV squamous or non-squamous non-small-cell lung cancer progressing during or after first-line platinum chemotherapy: docetaxel 75 mg/m2 with ramucirumab 10 mg/kg or placebo on day 1 of a 21-day cycle, with overall survival as the primary endpoint","sponsor":"Eli Lilly","result":"Median overall survival 10.5 against 9.1 months (hazard ratio 0.86, p=0.023); progression-free survival 4.5 against 3.0 months.","started":"2010-12","yearReported":2014,"enrolled":1253,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Ramucirumab with docetaxel","n":628,"value":10.5},{"name":"Placebo with docetaxel","n":625,"value":9.1}],"hr":0.86,"ci":[0.75,0.98],"p":"0.023","source":"https://doi.org/10.1016/S0140-6736(14)60845-X"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Ramucirumab with docetaxel","n":628,"value":4.5},{"name":"Placebo with docetaxel","n":625,"value":3}],"hr":0.76,"ci":[0.68,0.86],"source":"https://doi.org/10.1016/S0140-6736(14)60845-X"}]},{"id":"nct05076682","kind":"trial","name":"Reverse Triple Negative Immune Resistant Breast Cancer","aka":[],"tldr":"A phase 2 trial of Trastuzumab rezetecan, SHR-A2102, Adebrelimab and Mecapegfilgrastim in Triple-negative breast cancer, run by Fudan University, now recruiting.","summary":"Reverse Triple Negative Immune Resistant Breast Cancer is a phase 2 interventional study registered as NCT05076682 by Fudan University, with 80 participants planned, started 2022-06-30 and due to reach its primary completion in 2026-12-31. Interventions recorded: Choline, anti-PD-1 antibody and chemotherapy, Sodium Cromoglicate, Efavirenz, SHR-A1811, SHR-A2102, SHR-1316, Mecapegfilgrastim, AK131, Theophylline. Conditions recorded: Triple-negative Breast Cancer.\n\nLinked to the drug Mecapegfilgrastim because the registry names it among its interventions and Triple-negative breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05076682","url":"https://clinicaltrials.gov/study/NCT05076682"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":["trastuzumab-rezetecan","shr-a2102","adebrelimab","mecapegfilgrastim"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05076682","phase":"2","setting":"Reverse Triple Negative Immune Resistant Breast Cancer","sponsor":"Fudan University","started":"2022-06-30","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05973773","kind":"trial","name":"REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)","aka":["REZILIENT3"],"tldr":"A phase 3 trial testing Zipalertinib in non-small-cell lung cancer, active and no longer recruiting.","summary":"REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumours) is a phase 3 interventional study registered as NCT05973773, led by Taiho Oncology, and active but no longer recruiting on the registry. Official title: Randomised, Controlled, Open-label, Phase 3, Global Multi - Center Trial to Assess the Efficacy and Safety of Zipalertinib Plus Chemotherapy Versus Chemotherapy Alone, in Patients With Previously Untreated, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations. Planned enrolment is 285 participants (actual). The study started in 2023-12-18 and primary completion is expected in 2027-05-27. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05973773","url":"https://clinicaltrials.gov/study/NCT05973773"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["zipalertinib"],"companies":["taiho-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05973773","phase":"3","setting":"Randomized, Controlled, Open-label, Phase 3, Global Multi - Center Trial to Assess the Efficacy and Safety of Zipalertinib Plus Chemotherapy Versus Chemotherapy Alone, in Patients With Previously Untreated, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations","sponsor":"Taiho Oncology","started":"2023-12-18","startedType":"actual","enrolled":285,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04964284","kind":"trial","name":"rhTSH for Radioactive Iodine Remnant Ablation in Participants With Differentiated Thyroid Cancer (DTC)","aka":[],"tldr":"A phase 3 trial of Thyrotropin alfa in Thyroid cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, completed.","summary":"rhTSH for Radioactive Iodine Remnant Ablation in Participants With Differentiated Thyroid Cancer (DTC) is a phase 3 interventional study registered as NCT04964284 by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, with 390 participants recorded, started 2021-10-06 and reaching its primary completion in 2026-01-31. Interventions recorded: rhTSH, Radioiodine (131I). Conditions recorded: Differentiated Thyroid Cancer.\n\nLinked to the drug Thyrotropin alfa because the registry names it among its interventions and Thyroid cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04964284","url":"https://clinicaltrials.gov/study/NCT04964284"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["thyroid"],"sections":[],"technologies":[],"targets":[],"drugs":["thyrotropin-alfa"],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04964284","phase":"3","setting":"A Phase 3, Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of Recombinant Human Thyrotropin (rhTSH) for Radioactive Iodine (RAI) Remnant Ablation in Postoperative Participants With Differentiated Thyroid Cancer (DTC)","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","started":"2021-10-06","startedType":"actual","enrolled":390,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02934568","kind":"trial","name":"Ribociclib (LEE011) Rollover Study for Continued Access","aka":[],"tldr":"A phase 2 trial of LEE011 in advanced solid tumours, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Ribociclib (LEE011) Rollover Study for Continued Access is a phase 2 interventional study registered as NCT02934568 by Novartis Pharmaceuticals, with 22 participants enrolled, started 2016-12-15 and due to reach its primary completion in 2027-02-01. Interventions recorded: LEE011.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02934568","url":"https://clinicaltrials.gov/study/NCT02934568"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02934568","phase":"2","setting":"An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib as Single Agent or in Combination With Other Investigational Treatments","sponsor":"Novartis Pharmaceuticals","started":"2016-12-15","startedType":"actual","enrolled":22,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07447050","kind":"trial","name":"Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial","aka":["REFOCUS"],"tldr":"A phase 2 trial in colorectal cancer, run by University of California, Irvine, now recruiting.","summary":"Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial is a phase 2, randomised interventional study registered as NCT07447050 by University of California, Irvine, with a registry enrolment figure of 24 participants, started 2025-12-23 and due to reach its primary completion in 2027-12-31. Interventions recorded: Riluzole; Placebo. Conditions listed: Breast Cancer; Sarcoma; Gastric (Stomach) Cancer; Lung Cancer; Head and Neck Cancer; Colorectal Cancer; Ovarian Cancer; Liver Cancer; Genitourinary Cancer; Gynecologic Cancer. Primary outcome: Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer patients receiving chemotherapy. Colorectal eligibility wording from the registry: \"Patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07447050","url":"https://clinicaltrials.gov/study/NCT07447050"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07447050","phase":"2","setting":"RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)","sponsor":"University of California, Irvine","started":"2025-12-23","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06109779","kind":"trial","name":"Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)","aka":["ARTEMIDE-Biliary01"],"tldr":"A phase 3 trial of Rilvegostomig, Capecitabine and Gemcitabine + cisplatin in biliary tract cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01) is a phase 3 interventional study registered as NCT06109779 by AstraZeneca, with 760 participants enrolled, started 2023-12-04 and due to reach its primary completion in 2029-01-02. Interventions recorded: Rilvegostomig, Placebo, Capecitabine, Gemcitabine/Cisplatin and S-1 [Tegafur/Oteracil/gimeracil].","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06109779","url":"https://clinicaltrials.gov/study/NCT06109779"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["rilvegostomig","capecitabine","gemcitabine-cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06109779","phase":"3","setting":"A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)","sponsor":"AstraZeneca","started":"2023-12-04","startedType":"actual","enrolled":760,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06999252","kind":"trial","name":"Rimegepant Combined With PD-1 in Liver Metastasis Colorectal Cancer Patients","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"Rimegepant Combined With PD-1 in Liver Metastasis Colorectal Cancer Patients is a phase 2, interventional study registered as NCT06999252 by Fudan University, with a registry enrolment figure of 20 participants, started 2025-07-01 and due to reach its primary completion in 2028-12-01. Interventions recorded: Rimegepant; PD-1. Conditions listed: Colon Cancer. Primary outcome: objective response rate (ORR). Colorectal eligibility wording from the registry: \"Patients with histologically or cytologically confirmed locally advanced and advanced colorectal cancer that cannot be R0 resected;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06999252","url":"https://clinicaltrials.gov/study/NCT06999252"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06999252","phase":"2","setting":"The Combination of Rimegepant and PD-1 Inhibitor in the Treatment of Liver Metastasis Colorectal Cancer","sponsor":"Fudan University","started":"2025-07-01","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07044453","kind":"trial","name":"Risk-adapted Adjuvant Chemotherapy Guided by the Tumour Stage for Operated Pancreatic Adenocarcinoma Following Neoadjuvant Chemotherapy With mFOLFIRINOX","aka":["PANACHE 02"],"tldr":"A phase 2/3 trial in pancreatic cancer, run by University Hospital, Rouen, now recruiting.","summary":"Risk-adapted Adjuvant Chemotherapy Guided by the Tumour Stage for Operated Pancreatic Adenocarcinoma Following Neoadjuvant Chemotherapy With mFOLFIRINOX is a phase 2/3, randomised interventional study registered as NCT07044453 by University Hospital, Rouen, with a registry enrolment figure of 390 participants, started 2025-12-08 and due to reach its primary completion in 2030-09. Interventions recorded: Gem/Nabpaclitaxel infusion; mFOLFIRINOX infusion. Conditions listed: Resected Pancreatic Adenocarcinoma. Primary outcome: Disease Free Survival; Overall Survival. Pancreatic eligibility wording from the registry: \"Histologically confirmed resected pancreatic adenocarcinoma (R0 or R1) that has received 3 months of neoadjuvant mFOLFIRINOX, including anatomically resectable and borderline resectable tumors, in accordance with the definitions and therapeutic considerations provided in the TNCD (2024) and ESMO (20\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07044453","url":"https://clinicaltrials.gov/study/NCT07044453"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07044453","phase":"2/3","setting":"Risk-adapted Adjuvant Chemotherapy Guided by the Tumour Stage for Operated Pancreatic Adenocarcinoma Following Neoadjuvant Chemotherapy With mFOLFIRINOX - A Multicenter, FRENCH-PRODIGE Randomized Comparative Phase II/III Trial FRENCH26 - PRODIGE93 - PANACHE 02 Trial","sponsor":"University Hospital, Rouen","started":"2025-12-08","startedType":"actual","enrolled":390,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00057811","kind":"trial","name":"Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma","aka":[],"tldr":"A phase 2 trial of Doxorubicin, Cyclophosphamide, Methotrexate, Rasburicase, Leucovorin, Prednisone, Filgrastim, Rituximab, Cytarabine, Etoposide and Vincristine in Burkitt lymphoma and Acute lymphoblastic leukaemia, run by Children's Oncology Group, completed.","summary":"Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma is a phase 2 interventional study registered as NCT00057811 by Children's Oncology Group, with 97 participants recorded, started 2004-06 and reaching its primary completion in 2009-10. Interventions recorded: doxorubicin hydrochloride, cyclophosphamide, methotrexate, rasburicase, leucovorin calcium, prednisone, methylprednisolone, filgrastim, rituximab, cytarabine, etoposide, vincristine sulfate, hydrocortisone sodium succinate, laboratory biomarker analysis. Conditions recorded: Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Small Noncleaved Cell Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Childhood Small Noncleaved Cell Lymphoma, Stage III Childhood Large Cell Lymphoma, Stage III Childhood Small Noncleaved Cell Lymphoma, Stage IV Childhood Large Cell Lymphoma, Stage IV Childhood Small Noncleaved Cell Lymphoma, Untreated Childhood Acute Lymphoblastic Leukemia.\n\nLinked to the drug Rasburicase because the registry names it among its interventions and Burkitt lymphoma and Acute lymphoblastic leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00057811","url":"https://clinicaltrials.gov/study/NCT00057811"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["burkitt-lymphoma","all-leukemia"],"sections":[],"technologies":[],"targets":[],"drugs":["doxorubicin","cyclophosphamide","methotrexate","rasburicase","leucovorin","prednisone","filgrastim","rituximab","cytarabine","etoposide","vincristine"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00057811","phase":"2","setting":"A Pilot Study To Determine The Toxicity Of The Addition Of Rituximab To The Induction And Consolidation Phases And The Addition Of Rasburicase To The Reduction Phase In Children With Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated With LMB/FAB Therapy","sponsor":"Children's Oncology Group","started":"2004-06","yearReported":2014,"enrolled":97,"enrolledBasis":"registry","outcomes":[{"endpoint":"Minimal Residual Disease","primary":true,"unit":"%","arms":[{"name":"Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)","n":32,"value":22,"note":"95% CI 11 to 40; Figures from the ClinicalTrials.gov results section (first posted 2014-08-22), not from a publication"},{"name":"Group C (Chemotherapy, Monoclonal Antibody Therapy)","n":10,"value":70,"note":"95% CI 35 to 93"}],"source":"https://clinicaltrials.gov/study/NCT00057811?tab=results"}]},{"id":"nct07413939","kind":"trial","name":"RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive","aka":["BREnnA"],"tldr":"A phase 2/3 trial testing RO7771950 in HER2-positive breast cancer and HR-positive / HER2-negative breast cancer, now recruiting.","summary":"RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive is a phase 2/3 interventional study registered as NCT07413939, led by Hoffmann-La Roche, and recruiting on the registry. Official title: A Two-part, Seamless, Multicenter, Randomised, Open-label, Adaptive Phase II/III Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Positive Breast Cancer, With or Without Central Nervous System Metastases. Planned enrolment is 650 participants (estimated). The study started in 2026-05-21 and primary completion is expected in 2029-05-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07413939","url":"https://clinicaltrials.gov/study/NCT07413939"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["ro7771950"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07413939","phase":"2/3","setting":"A Two-part, Seamless, Multicenter, Randomized, Open-label, Adaptive Phase II/III Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Positive Breast Cancer, With or Without Central Nervous System Metastases","sponsor":"Hoffmann-La Roche","started":"2026-05-21","startedType":"actual","enrolled":650,"enrolledBasis":"registry","outcomes":[]},{"id":"roar-atc","kind":"trial","name":"ROAR (anaplastic thyroid cancer cohort)","aka":[],"tldr":"Turned the thyroid cancer with the shortest survival, once measured in months, into a treatable disease for the third of patients whose tumours carry a BRAF mutation.","summary":"ROAR, trial NCT02034110 sponsored by Novartis, is the phase 2 basket study whose anaplastic thyroid cancer cohort turned the thyroid cancer with the shortest survival, once measured in months, into a treatable disease for the roughly third of patients whose tumours carry a BRAF V600E mutation. In 36 patients treated with dabrafenib plus trametinib the objective response rate was 56 percent, with survival far beyond historical expectations in the 2022 update in Annals of Oncology, leading to FDA approval in May 2018 as the first targeted therapy for the disease; neoadjuvant use now enables surgery in previously unresectable tumours. OnCo links it to thyroid cancer, BRAF as a target, the dabrafenib plus trametinib record, MD Anderson, Maria E. Cabanillas and the pairing of BRAF and MEK inhibition before surgery. Whether adding PD-1 blockade should become standard is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02034110","url":"https://clinicaltrials.gov/study/NCT02034110"},{"label":"Updated analysis, Annals of Oncology 2022","url":"https://www.sciencedirect.com/science/article/pii/S0923753422000059"}],"tags":[],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["braf"],"drugs":["dabrafenib-trametinib"],"companies":["novartis"],"institutions":["md-anderson"],"pathways":[],"terms":[],"trials":[],"people":["maria-cabanillas"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02034110","phase":"2","setting":"BRAF V600E-mutant anaplastic thyroid cancer: dabrafenib + trametinib","sponsor":"Novartis","result":"ORR 56%; median OS 15 months.","started":"2014-03-12","startedType":"actual","yearReported":2018,"enrolled":36,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Dabrafenib + trametinib","n":36,"value":56}],"source":"https://www.sciencedirect.com/science/article/pii/S0923753422000059"}],"replication":"Consistent with MD Anderson real-world series of neoadjuvant BRAF/MEK in ATC."},{"id":"roar","kind":"trial","name":"ROAR (Rare Oncology Agnostic Research) basket: BRAF V600E biliary tract cancer cohort","aka":["ROAR"],"tldr":"In the ROAR basket trial, the BRAF-blocking pair dabrafenib and trametinib shrank tumours in about half of 43 people with bile duct or gallbladder cancer carrying the BRAF V600E mutation, which is found in roughly 5 percent of biliary cancers. The pair is approved for any solid tumour with this mutation in the United States and is listed by guidelines for biliary cancer.","summary":"ROAR (NCT02034110) was a phase 2, open-label, single-arm, multicentre basket trial of dabrafenib plus trametinib in BRAF V600E-mutated rare cancers across nine cohorts (anaplastic thyroid, biliary tract, gastrointestinal stromal tumour, small-bowel adenocarcinoma, low- and high-grade glioma, hairy cell leukaemia, multiple myeloma and adenocarcinoma of unknown primary). The biliary tract cohort enrolled 43 previously treated patients between 2014 and 2018; investigator-assessed overall response, the primary endpoint, was achieved by 22 of 43 (51 percent, 95 percent confidence interval 36 to 67) and independent-review response by 20 of 43 (47 percent), at a median follow-up of 10 months. The most common grade 3 or worse adverse event was raised gamma-glutamyltransferase (12 percent); 40 percent had serious adverse events, 21 percent treatment-related, most often pyrexia. BRAF V600E is found in about 5 percent of biliary tract tumours and is less common in gallbladder cancer than in intrahepatic cholangiocarcinoma. The FDA approved dabrafenib with trametinib for BRAF V600E solid tumours on a tumour-agnostic basis in June 2022 with ROAR among the supporting trials; NCCN lists the pair for biliary cancer, and in the UK the combination is not appraised by NICE for biliary cancer.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02034110","url":"https://clinicaltrials.gov/study/NCT02034110"},{"label":"Subbiah et al., Lancet Oncology 2020: dabrafenib plus trametinib in BRAF V600E biliary tract cancer (ROAR)","url":"https://doi.org/10.1016/S1470-2045(20)30321-1"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer","rare-cancers"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["braf"],"drugs":["dabrafenib-trametinib","dabrafenib","trametinib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":["tumour-agnostic","basket-umbrella-platform"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-roar-lancet-oncol-2020","paper-roar-ann-oncol-2022-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02034110","phase":"2","setting":"BRAF V600E-mutated rare cancers in nine histology cohorts, including previously treated unresectable, metastatic or recurrent biliary tract cancer (n=43): dabrafenib 150 mg twice daily plus trametinib 2 mg daily, single arm","sponsor":"Novartis Pharmaceuticals","result":"Biliary cohort ORR 51% (22/43, investigator) and 47% (independent review); grade 3 or worse GGT rise 12%.","started":"2014-03-12","startedType":"actual","yearReported":2020,"enrolled":206,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate, biliary tract cancer cohort (investigator-assessed)","primary":true,"unit":"%","arms":[{"name":"Dabrafenib + trametinib","n":43,"value":51,"note":"95% CI 36 to 67"}],"source":"https://doi.org/10.1016/S1470-2045(20)30321-1"},{"endpoint":"Overall response rate, biliary tract cancer cohort (independent review)","unit":"%","arms":[{"name":"Dabrafenib + trametinib","n":43,"value":47,"note":"95% CI 31 to 62"}],"source":"https://doi.org/10.1016/S1470-2045(20)30321-1"}]},{"id":"nct07342478","kind":"trial","name":"ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL","aka":[],"tldr":"A phase 3 trial testing Rocbrutinib in chronic lymphocytic leukaemia, now recruiting.","summary":"ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL is a phase 3 interventional study registered as NCT07342478, led by Newave Pharmaceutical, and recruiting on the registry. Official title: A Phase 3 Open-Label, Randomised, Multicenter Study of Rocbrutinib (LP-168) vs Pirtobrutinib in Covalent BTK Inhibitor (cBTKi) Pretreated Relapsed or Refractory Chronic Lymphocytic Leukaemia (CLL) / Small Lymphocytic Lymphoma (SLL) Subjects. Planned enrolment is 306 participants (estimated). The study started in 2026-04-23 and primary completion is expected in 2029-10-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07342478","url":"https://clinicaltrials.gov/study/NCT07342478"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":[],"targets":[],"drugs":["rocbrutinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07342478","phase":"3","setting":"A Phase 3 Open-Label, Randomized, Multicenter Study of Rocbrutinib (LP-168) vs Pirtobrutinib in Covalent BTK Inhibitor (cBTKi) Pretreated Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) Subjects","sponsor":"Newave Pharmaceutical","started":"2026-04-23","startedType":"actual","enrolled":306,"enrolledBasis":"registry","outcomes":[]},{"id":"rockstar","kind":"trial","name":"ROCKstar","aka":["KD025-213","DRI17633","The ROCKstar Study"],"tldr":"ROCKstar showed that belumosudil, a daily pill, improved chronic graft-versus-host disease in about three in four people whose disease had not settled after at least two earlier treatments, which led to its US approval in 2021.","summary":"ROCKstar (study KD025-213) was an open-label, randomised phase 2 registration study of belumosudil, an oral ROCK2 inhibitor, in patients with chronic graft-versus-host disease after a donor stem-cell transplant whose disease was still active after 2 to 5 previous lines of systemic therapy. Patients were randomised to 200 mg once daily (66) or 200 mg twice daily (66). There was no control arm: the primary endpoint was best overall response by the 2014 NIH consensus criteria.\n\nAt a median follow-up of 14 months the best response rate was 74 percent with once-daily and 77 percent with twice-daily dosing (95% CI 62 to 84 and 65 to 87), with high response rates in all subgroups and complete responses in every affected organ. The median duration of response was 54 weeks, 44 percent of patients stayed on treatment for at least a year, and symptoms improved in 59 and 62 percent. Sixteen patients (12 percent) stopped because of possibly drug-related adverse events (Blood 2021).\n\nThe FDA approved the once-daily dose on 16 July 2021 on a stricter analysis of 65 patients that counted responses only through cycle 7 day 1: 75 percent responded (6 percent complete, 69 percent partial), the median duration of response was 1.9 months on that definition, and 62 percent of responders were alive without a new systemic therapy at least 12 months after response (FDA approval summary, Clinical Cancer Research 2022; the Rezurock label Table 6 gives the same figures). The registry lists 159 participants in all, including adolescent arms, and records the study as terminated in December 2023 because adolescents were hard to recruit, with no safety concern.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03640481","url":"https://clinicaltrials.gov/study/NCT03640481"},{"label":"Blood 2021","url":"https://doi.org/10.1182/blood.2021012021"},{"label":"FDA approval summary (Clinical Cancer Research 2022)","url":"https://doi.org/10.1158/1078-0432.CCR-21-4176"},{"label":"Rezurock label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=102e4ef4-7f84-4e34-8df1-479c24d1575d"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["belumosudil"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":["gvhd","allogeneic-transplant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-rockstar-blood-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03640481","phase":"2","setting":"Chronic graft-versus-host disease after allogeneic stem-cell transplant, still active after 2 to 5 previous lines of systemic therapy: belumosudil 200 mg once daily against 200 mg twice daily, with no control arm","sponsor":"Kadmon, a Sanofi Company","result":"Best overall response 74% (200 mg once daily) and 77% (200 mg twice daily); the FDA analysis of the once-daily dose found 75% through cycle 7 day 1.","started":"2018-10-11","startedType":"actual","yearReported":2021,"enrolled":159,"enrolledBasis":"registry","outcomes":[{"endpoint":"Best overall response rate (2014 NIH criteria)","primary":true,"unit":"%","arms":[{"name":"Belumosudil 200 mg once daily","n":66,"value":74,"note":"95% CI 62 to 84; median follow-up 14 months"},{"name":"Belumosudil 200 mg twice daily","n":66,"value":77,"note":"95% CI 65 to 87"}],"source":"https://doi.org/10.1182/blood.2021012021"},{"endpoint":"Overall response rate through cycle 7 day 1 (FDA approval analysis)","unit":"%","arms":[{"name":"Belumosudil 200 mg once daily","n":65,"value":75,"note":"95% CI 63 to 85; complete response 6%, partial response 69%"}],"source":"https://doi.org/10.1158/1078-0432.CCR-21-4176"},{"endpoint":"Symptom improvement (Lee Symptom Scale)","unit":"%","arms":[{"name":"Belumosudil 200 mg once daily","n":66,"value":59},{"name":"Belumosudil 200 mg twice daily","n":66,"value":62}],"source":"https://doi.org/10.1182/blood.2021012021"}],"replication":"No randomised trial has compared belumosudil with another treatment for chronic graft-versus-host disease."},{"id":"nct02072811","kind":"trial","name":"Role of the Therapy Tailored to Risk Factors in Treating Adult Patients (≤60) With Acute Myeloid Leukemia","aka":[],"tldr":"A phase 3 trial of Cladribine, Daunorubicin and Mitoxantrone in Acute myeloid leukaemia, run by dr hab. n. med. Agnieszka Wierzbowska, with a status the registry has not verified recently.","summary":"Role of the Therapy Tailored to Risk Factors in Treating Adult Patients (≤60) With Acute Myeloid Leukemia is a phase 3 interventional study registered as NCT02072811 by dr hab. n. med. Agnieszka Wierzbowska, with 400 participants planned, started 2014-02 and due to reach its primary completion in 2018-02. Interventions recorded: DAC, CLAG, Consolidation, I HAM cycle, II Consolidation HiDAraC, Consolidation, III HiDAraC cycle. Conditions recorded: Acute Myeloid Leukemia.\n\nLinked to the drug Cladribine because the registry names it among its interventions and Acute myeloid leukaemia among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02072811","url":"https://clinicaltrials.gov/study/NCT02072811"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":["cladribine","daunorubicin","mitoxantrone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02072811","phase":"3","setting":"Evaluation of the Efficacy of Induction-consolidation Treatment Using a Double Induction in Patients With AML <60 Years Old, Depending on the Percentage of Blasts in the 14 Day, Residual Disease and Leukemic Hematopoietic Cells","sponsor":"dr hab. n. med. Agnieszka Wierzbowska","started":"2014-02","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04421963","kind":"trial","name":"Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib","aka":["ROSY-O"],"tldr":"A phase 3 trial of Olaparib in ovarian cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib is a phase 3 interventional study registered as NCT04421963 by AstraZeneca, with 185 participants enrolled, started 2020-08-04 and due to reach its primary completion in 2027-04-06. Interventions recorded: Olaparib. Conditions listed: Ovarian Cancer, Breast Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04421963","url":"https://clinicaltrials.gov/study/NCT04421963"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["olaparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04421963","phase":"3","setting":"Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment","sponsor":"AstraZeneca","started":"2020-08-04","startedType":"actual","enrolled":185,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05629234","kind":"trial","name":"Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T)","aka":["ROSY-T"],"tldr":"A phase 3 trial of Osimertinib in advanced solid tumours, run by AstraZeneca, active and no longer recruiting.","summary":"Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T) is a phase 3 interventional study registered as NCT05629234 by AstraZeneca, with 37 participants enrolled, started 2023-05-08 and due to reach its primary completion in 2027-02-22. Interventions recorded: Osimertinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05629234","url":"https://clinicaltrials.gov/study/NCT05629234"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":["astrazeneca","parexel"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05629234","phase":"3","setting":"ROSY-T: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment","sponsor":"AstraZeneca","started":"2023-05-08","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05201066","kind":"trial","name":"Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.","aka":[],"tldr":"A phase 2 trial of Decitabine, Azacitidine and Venetoclax in myelodysplastic syndromes / neoplasms, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab. is a phase 2 interventional study registered as NCT05201066 by Novartis Pharmaceuticals, with 33 participants enrolled, started 2023-02-28 and due to reach its primary completion in 2028-02-14. Interventions recorded: decitabine, spartalizumab, sabatolimab, azacitidine, venetoclax and INQOVI (oral decitabine).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05201066","url":"https://clinicaltrials.gov/study/NCT05201066"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mds"],"sections":[],"technologies":[],"targets":[],"drugs":["decitabine","azacitidine","venetoclax","spartalizumab","sabatolimab"],"companies":["advanced-accelerator-applications"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05201066","phase":"2","setting":"An Open-label, Multicenter, Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.","sponsor":"Novartis Pharmaceuticals","started":"2023-02-28","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07468071","kind":"trial","name":"Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other","aka":["KontRASt-R"],"tldr":"A phase 1/2 trial of JDQ443, Trametinib, Cetuximab in non-small-cell lung cancer and small-cell lung cancer, run by Novartis Pharmaceuticals, now recruiting.","summary":"Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments is a phase 1/2 interventional study registered as NCT07468071 by Novartis Pharmaceuticals, with 40 participants planned, started 2026-06-08 and due to reach its primary completion in 2029-06-11. Interventions recorded: Opnurasib, TNO155, trametinib, cetuximab, tislelizumab. Conditions listed: Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer, Advanced Solid Tumors Harboring the KRAS G12C Mutation. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07468071","url":"https://clinicaltrials.gov/study/NCT07468071"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["jdq443","trametinib","cetuximab","tislelizumab"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07468071","phase":"1/2","setting":"KontRASt-R: An Open-label, Multi-center, Rollover Study for Participants Who Have Been Previously Enrolled Into a Novartis-sponsored Opnurasib (JDQ443) Study and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments","sponsor":"Novartis Pharmaceuticals","started":"2026-06-08","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04509700","kind":"trial","name":"Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)","aka":[],"tldr":"A phase 2 trial of Parsaclisib, Ruxolitinib and Ibrutinib in advanced solid tumours, run by Incyte Corporation, active and no longer recruiting.","summary":"Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) is a phase 2 interventional study registered as NCT04509700 by Incyte Corporation, with 112 participants enrolled, started 2020-08-03 and due to reach its primary completion in 2026-11-05. Interventions recorded: Parsaclisib, parsaclisib + itacitinib, parsaclisib + ruxolitinib and parsaclisib + ibrutinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04509700","url":"https://clinicaltrials.gov/study/NCT04509700"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["parsaclisib","ruxolitinib","ibrutinib"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04509700","phase":"2","setting":"A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)","sponsor":"Incyte Corporation","started":"2020-08-03","startedType":"actual","enrolled":112,"enrolledBasis":"registry","outcomes":[]},{"id":"roman","kind":"trial","name":"ROMAN","aka":["GTI-4419-301","Reduction in Oral Mucositis With Avasopasem Manganese"],"tldr":"ROMAN showed that an infusion of avasopasem before each dose of radiotherapy cut severe mouth ulcers during head and neck chemoradiation from about two thirds of patients to about half and shortened them from 18 days to 8, but the effect was smaller than an earlier trial had promised and the FDA asked for another study before approval.","summary":"ROMAN (NCT03689712; organisation id GTI-4419-301) was a double-blind, placebo-controlled phase 3 trial of avasopasem manganese (GC4419), a superoxide dismutase mimetic, in patients with locally advanced head and neck cancer receiving 60 to 72 Gy of intensity-modulated radiotherapy (more than 50 Gy to at least two oral mucosal sites) with cisplatin every three weeks or weekly. Patients were randomised 3:2 to avasopasem 90 mg or placebo before each radiotherapy fraction. Severe oral mucositis (WHO grade 3 or 4) was assessed twice weekly during radiotherapy and weekly for two weeks after; the primary endpoint was its cumulative incidence through the end of radiotherapy.\n\nOf 455 patients randomised, 407 (241 avasopasem, 166 placebo) formed the primary analysis population. Severe oral mucositis occurred in 54 percent on avasopasem versus 64 percent on placebo (relative risk 0.84; 95 percent CI 0.71 to 1.00; p = 0.045), and its median duration was 8 versus 18 days (p = 0.002); onset was nominally delayed (median 49 versus 38 days). Grade 4 mucositis incidence and duration were not significantly reduced (27 percent, p = 0.052; 24 percent, p = 0.143). Adverse-event frequencies were comparable, tumour outcomes were maintained at one year, and two-year overall survival was 89 percent (95 percent CI 84 to 93) with avasopasem versus 93 percent (88 to 96) with placebo.\n\nThe eClinicalMedicine 2025 report states that the incidence benefit was smaller than the phase 2b trial had predicted, that a contribution of avasopasem to adverse events could not be excluded, and that ROMAN did not give a sufficiently favourable benefit-risk determination for FDA approval; a confirmatory phase 3 was requested. The FDA issued a complete response letter in August 2023, and the drug remains investigational. The registry condition is oral mucositis rather than a cancer, which is why the automated pass never attached the trial to the drug.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03689712","url":"https://clinicaltrials.gov/study/NCT03689712"},{"label":"eClinicalMedicine 2025","url":"https://doi.org/10.1016/j.eclinm.2025.103539"}],"tags":[],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":["radioprotectors"],"targets":[],"drugs":["avasopasem-manganese","cisplatin"],"companies":["galera-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-roman-anderson-eclinicalmedicine-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03689712","phase":"3","setting":"Locally advanced, non-metastatic head and neck cancer receiving intensity-modulated radiotherapy plus cisplatin: avasopasem manganese 90 mg versus placebo infused before each radiotherapy fraction, randomised 3:2","sponsor":"Galera Therapeutics","result":"Severe oral mucositis incidence 54% vs 64% (relative risk 0.84, 95% CI 0.71 to 1.00; p = 0.045); median duration 8 vs 18 days (p = 0.002). Primary met, but the FDA issued a complete response letter and asked for a confirmatory trial.","started":"2018-10-03","startedType":"actual","yearReported":2025,"enrolled":455,"enrolledBasis":"registry","outcomes":[{"endpoint":"Severe oral mucositis (WHO grade 3 or 4) incidence through the end of radiotherapy","primary":true,"unit":"%","arms":[{"name":"Avasopasem manganese 90 mg","n":241,"value":54,"note":"Relative risk 0.84 vs placebo; 95% CI 0.71 to 1.00"},{"name":"Placebo","n":166,"value":64}],"p":"0.045","source":"https://doi.org/10.1016/j.eclinm.2025.103539"},{"endpoint":"Median duration of severe oral mucositis","unit":"days","arms":[{"name":"Avasopasem manganese 90 mg","n":241,"value":8},{"name":"Placebo","n":166,"value":18}],"p":"0.002","source":"https://doi.org/10.1016/j.eclinm.2025.103539"},{"endpoint":"Median time to onset of severe oral mucositis","unit":"days","arms":[{"name":"Avasopasem manganese 90 mg","n":241,"value":49,"note":"Nominal p = 0.002"},{"name":"Placebo","n":166,"value":38}],"source":"https://doi.org/10.1016/j.eclinm.2025.103539"},{"endpoint":"Overall survival at 2 years","unit":"%","arms":[{"name":"Avasopasem manganese 90 mg","value":89,"note":"95% CI 84 to 93; tumour outcomes were maintained at one year"},{"name":"Placebo","value":93,"note":"95% CI 88 to 96"}],"source":"https://doi.org/10.1016/j.eclinm.2025.103539"}],"replication":"The randomised phase 2b (Anderson, JCO 2020; NCT02508389) had reported a larger effect on the same endpoints; ROMAN confirmed the direction but not the size, and the confirmatory phase 3 the FDA requested has not reported."},{"id":"romana-1-2","kind":"trial","name":"ROMANA 1 and ROMANA 2","aka":[],"tldr":"ROMANA 1 and 2 were two phase 3 trials of an appetite-hormone mimic in lung cancer patients with wasting. Patients gained muscle but not grip strength, which split regulators: approved in Japan, rejected in Europe.","summary":"ROMANA 1 (n=484) and ROMANA 2 (n=495) were identical double-blind trials with co-primary endpoints of lean body mass (DXA) and handgrip strength over 12 weeks. Lean body mass increased with anamorelin (ROMANA 1: +0.99 kg vs -0.47 kg; ROMANA 2: +0.65 kg vs -0.98 kg), and body weight, appetite and anorexia-cachexia symptom scores improved, but handgrip strength did not differ from placebo in either trial. Hyperglycaemia and nausea were the main adverse events. The EMA refused marketing authorisation in 2017 citing the absence of a functional benefit; Japan approved anamorelin (Adlumiz) in 2021 for NSCLC, gastric, pancreatic and colorectal cancer cachexia. ROMANA established that lean mass can be pharmacologically increased in cachexia, and that regulators want function or survival, which shaped the endpoint strategy for GDF-15 antagonists.","status":"mixed","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT01387269","url":"https://clinicaltrials.gov/study/NCT01387269"},{"label":"ClinicalTrials.gov NCT01387282","url":"https://clinicaltrials.gov/study/NCT01387282"},{"label":"Temel et al. (Lancet Oncol 2016)","url":"https://doi.org/10.1016/S1470-2045(15)00558-6"}],"tags":[],"related":["idea-bio2-anamorelin-access","idea-bio2-cachexia-function-endpoint"],"cancers":["nsclc"],"sections":["nutrition-lifestyle","supportive-care"],"technologies":["cachexia-appetite-pharmacotherapy","cachexia-therapy"],"targets":[],"drugs":[],"companies":["helsinn"],"institutions":["ncc-japan"],"pathways":["cachexia-biology"],"terms":["cachexia","sarcopenia","body-composition"],"trials":[],"people":[],"bottlenecks":["b-cachexia-supportive","b-regulatory-fragmentation"],"keyPapers":["paper-romana-1-2-lancet-oncol-2016"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01387269","phase":"3","setting":"Unresectable stage III/IV NSCLC with cachexia (weight loss over 5% in 6 months or BMI under 20): anamorelin 100 mg/day vs placebo for 12 weeks","sponsor":"Helsinn Therapeutics","result":"Lean body mass increased (about +1 to +1.5 kg vs placebo); handgrip strength unchanged.","started":"2011-07","yearReported":2016,"enrolled":979,"enrolledBasis":"registry","outcomes":[{"endpoint":"Change in lean body mass over 12 weeks (ROMANA 1)","primary":true,"unit":"kg","arms":[{"name":"Anamorelin","n":323,"value":0.99},{"name":"Placebo","n":161,"value":-0.47}],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(15)00558-6"},{"endpoint":"Change in lean body mass over 12 weeks (ROMANA 2)","primary":true,"unit":"kg","arms":[{"name":"Anamorelin","n":330,"value":0.65},{"name":"Placebo","n":165,"value":-0.98}],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(15)00558-6"}],"replication":"Japanese phase 2/3 trials (ONO-7643) in NSCLC and GI cancers reproduced the lean mass effect; the ROMANA 3 extension confirmed safety over 24 weeks."},{"id":"nct07381764","kind":"trial","name":"ROMANCE: \"Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer\"","aka":["ROMANCE - GOIM"],"tldr":"A phase 2 trial of cetuximab, bevacizumab (glioblastoma use), fOLFIRI (5-FU, leucovorin, irinotecan) and trifluridine/tipiracil in colorectal cancer, run by Gruppo Oncologico Italia Meridionale, now recruiting.","summary":"ROMANCE: \"Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer\" is a phase 2, randomised interventional study registered as NCT07381764 by Gruppo Oncologico Italia Meridionale, with a registry enrolment figure of 150 participants, started 2026-03-20 and due to reach its primary completion in 2031-03-30. Interventions recorded: Erbitux (Cetuximab); Bevacizumab; Irinotecan; Trifluridine/tipiracil. Conditions listed: Metastatic Colorectal Cancer (CRC). Primary outcome: Objective Response Rate (ORR). Colorectal eligibility wording from the registry: \"Diagnosis of histologically or cytologically confirmed colorectal cancer\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07381764","url":"https://clinicaltrials.gov/study/NCT07381764"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","mrd-testing","topoisomerase-inhibitors"],"targets":[],"drugs":["cetuximab","bevacizumab-glioma","folfiri","trifluridine-tipiracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07381764","phase":"2","setting":"ROMANCE GOIM Study: A Phase II, Open Label, Multicenter Trial Investigating Irinotecan Plus Cetuximab Rechallenge Compared With Trifluridine/Tipiracil Plus Bevacizumab as Third Line Treatment in Circulating Tumor DNA Molecularly Selected Metastatic Colorectal Cancer","sponsor":"Gruppo Oncologico Italia Meridionale","started":"2026-03-20","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07586813","kind":"trial","name":"Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors","aka":["N01-A-PICIT-GI"],"tldr":"A phase 2 trial of tretinoin (all-trans retinoic acid, ATRA) in pancreatic cancer, run by Peking University People's Hospital, now recruiting.","summary":"Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors is a phase 2, randomised interventional study registered as NCT07586813 by Peking University People's Hospital, with a registry enrolment figure of 220 participants, started 2025-12-22 and due to reach its primary completion in 2027-10-31. Interventions recorded: Romiplostim N01; All-trans retinoic acid. Conditions listed: Persistent Isolated Chemotherapy-Induced Thrombocytopenia; Chemotherapy-Induced Thrombocytopenia; Gastrointestinal Neoplasms; Pancreatic Cancer; Colorectal Cancer. Primary outcome: Overall Platelet Response Rate at Week 12. Pancreatic eligibility wording from the registry: \"Prior diagnosis of a gastrointestinal/digestive system solid tumor, including but not limited to gastrointestinal tract, pancreatic, or colorectal cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07586813","url":"https://clinicaltrials.gov/study/NCT07586813"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["tretinoin-atra"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07586813","phase":"2","setting":"A Prospective, Randomized, Open-Label, Controlled Study of Romiplostim N01 Combined With All-Trans Retinoic Acid Versus Romiplostim N01 Alone for Persistent Isolated Chemotherapy-Induced Thrombocytopenia in Patients With Complete Remission of Gastrointestinal Solid Tumors","sponsor":"Peking University People's Hospital","started":"2025-12-22","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04285086","kind":"trial","name":"Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance","aka":["SURPASS ET"],"tldr":"A phase 3 trial of Ropeginterferon alfa-2b and Anagrelide in myeloproliferative neoplasms, run by PharmaEssentia, active and no longer recruiting.","summary":"Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance is a phase 3 interventional study registered as NCT04285086 by PharmaEssentia, with 174 participants enrolled, started 2020-08-25 and due to reach its primary completion in 2024-11-12. Interventions recorded: Ropeginterferon alfa-2b and Anagrelide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04285086","url":"https://clinicaltrials.gov/study/NCT04285086"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","essential-thrombocythaemia"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["ropeginterferon-alfa-2b","anagrelide"],"companies":["pharmaessentia"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04285086","phase":"3","setting":"A Phase 3, Open-Label, Multicenter, Randomized, Active-controlled Study to Assess PK and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as 2nd Line Therapy for Essential Thrombocythemia (SURPASS ET): The Core Study and Its Extension Study.","sponsor":"PharmaEssentia","started":"2020-08-25","startedType":"actual","enrolled":174,"enrolledBasis":"registry","outcomes":[]},{"id":"rosella","kind":"trial","name":"ROSELLA / GOG-3073","aka":[],"tldr":"Blocking cortisol signalling in tumour cells made chemotherapy work better and extended life in resistant ovarian cancer.","summary":"ROSELLA, also GOG-3073, trial NCT05257408 sponsored by Corcept and published in the Lancet in 2025, showed that blocking cortisol signalling in tumour cells with relacorilant makes nab-paclitaxel chemotherapy work better and extends life in platinum-resistant ovarian cancer. It randomised 381 women with one to three prior lines to relacorilant plus nab-paclitaxel or nab-paclitaxel alone, met its primary progression-free survival endpoint and improved overall survival, leading to FDA approval in the first quarter of 2026 as Lifyorli, the first-in-class glucocorticoid receptor antagonist in oncology. OnCo links it to ovarian cancer, relacorilant, paclitaxel and Corcept Therapeutics, and the record notes it as a chemosensitisation mechanism rather than a new cytotoxic. Whether the approach transfers to other chemotherapy-treated cancers is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05257408","url":"https://clinicaltrials.gov/study/NCT05257408"}],"tags":[],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["relacorilant","paclitaxel"],"companies":["corcept"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05257408","phase":"3","setting":"Platinum-resistant ovarian cancer, 1-3 prior lines: relacorilant + nab-paclitaxel vs nab-paclitaxel","sponsor":"Corcept","result":"OS 16.0 vs 11.9 months (HR 0.69).","started":"2022-06-29","startedType":"actual","yearReported":2025,"enrolled":381,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Relacorilant + nab-paclitaxel","n":188,"value":6.5},{"name":"Nab-paclitaxel","n":193,"value":5.5}],"hr":0.7,"ci":[0.54,0.91],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01011-6/fulltext"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Relacorilant + nab-paclitaxel","value":16},{"name":"Nab-paclitaxel","value":11.9}],"hr":0.69,"source":"https://www.targetedonc.com/view/new-approaches-reshape-treatment-for-low-grade-serous-and-resistant-disease"}]},{"id":"nct07173751","kind":"trial","name":"ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer","aka":["ROSETTA Breast-01"],"tldr":"A phase 3 trial of PM8002, Gemcitabine, Carboplatin and Eribulin in triple-negative breast cancer, run by BioNTech SE, now recruiting.","summary":"ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer is a phase 3 interventional study registered as NCT07173751 by BioNTech SE, with 558 participants planned, started 2025-10-30 and due to reach its primary completion in 2029-12. Interventions recorded: Pumitamig, Nab-paclitaxel/Paclitaxel, Gemcitabine, Carboplatin, Eribulin and Matching placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07173751","url":"https://clinicaltrials.gov/study/NCT07173751"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002","gemcitabine","carboplatin","eribulin"],"companies":["biontech","bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07173751","phase":"3","setting":"A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease","sponsor":"BioNTech SE","started":"2025-10-30","startedType":"actual","enrolled":558,"enrolledBasis":"registry","outcomes":[]},{"id":"rosewood","kind":"trial","name":"ROSEWOOD","aka":["Zanubrutinib plus obinutuzumab in follicular lymphoma","ROSEWOOD trial"],"tldr":"Adding a targeted tablet to an antibody roughly doubled the chance of the lymphoma shrinking and tripled the time before it grew again, in people whose follicular lymphoma had already returned twice.","summary":"Follicular lymphoma was not a disease in which Bruton tyrosine kinase inhibitors had performed well as single agents, so ROSEWOOD tested zanubrutinib in combination with the type II anti-CD20 antibody obinutuzumab rather than alone. 217 patients with relapsed or refractory follicular lymphoma after at least two lines, including an anti-CD20 antibody and an alkylating agent, were randomised 2 to 1 to the combination (145) or to obinutuzumab alone (72).\n\nAt a median follow-up of 20.2 months the primary endpoint was met: overall response rate by independent central review was 69 per cent with the combination against 46 per cent with obinutuzumab alone (p = 0.001). Complete response was 39 against 19 per cent, the 18-month duration of response rate 69 against 42 per cent, and median progression-free survival 28.0 months against 10.4 (hazard ratio 0.50, 95 per cent confidence interval 0.33 to 0.75).\n\nIt is a randomised phase 2, so the comparator is an antibody that few would use alone in this setting, and the result establishes activity rather than a place in a sequence. It is nonetheless the clearest evidence that the Bruton tyrosine kinase pathway is worth attacking in follicular lymphoma when the antibody is a type II one.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT03332017","url":"https://clinicaltrials.gov/study/NCT03332017"},{"label":"Journal of Clinical Oncology 2023","url":"https://doi.org/10.1200/JCO.23.00775"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["follicular-lymphoma","non-hodgkin-lymphoma"],"sections":["targeted-therapy","immunotherapy"],"technologies":["monoclonal-antibody"],"targets":["btk","cd20"],"drugs":["zanubrutinib","obinutuzumab"],"companies":[],"institutions":[],"pathways":["bcr-signalling"],"terms":["orr","complete-response"],"trials":[],"people":[],"bottlenecks":["b-combination-space"],"keyPapers":["paper-rosewood-zanubrutinib-obinutuzumab-follicular-jco-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03332017","phase":"2","setting":"Relapsed or refractory follicular lymphoma after two or more lines including an anti-CD20 antibody and an alkylating agent: zanubrutinib with obinutuzumab against obinutuzumab alone","sponsor":"BeiGene","result":"Overall response 69 against 46 per cent (p = 0.001) and median progression-free survival 28.0 against 10.4 months (hazard ratio 0.50).","started":"2017-11-14","startedType":"actual","yearReported":2023,"enrolled":217,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate by independent central review","primary":true,"unit":"%","arms":[{"name":"Zanubrutinib with obinutuzumab","n":145,"value":69},{"name":"Obinutuzumab alone","n":72,"value":46}],"p":"0.001","source":"https://doi.org/10.1200/JCO.23.00775"},{"endpoint":"Progression-free survival (median)","unit":"months","arms":[{"name":"Zanubrutinib with obinutuzumab","n":145,"value":28},{"name":"Obinutuzumab alone","n":72,"value":10.4}],"hr":0.5,"ci":[0.33,0.75]}],"replication":"Not replicated; the comparator arm was obinutuzumab monotherapy rather than a combination in common use."},{"id":"nct05966194","kind":"trial","name":"RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer","aka":["KEVLARx"],"tldr":"A phase 2 trial of Cisplatin in head and neck squamous cell carcinoma, run by EpicentRx, Inc., active and no longer recruiting.","summary":"RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer is a phase 2 interventional study registered as NCT05966194 by EpicentRx, Inc., with 216 participants enrolled, started 2024-04-02 and due to reach its primary completion in 2027-07-01. Interventions recorded: RRx-001, Intensity Modulated Radiation Therapy (IMRT) and Cisplatin for injection 100 mg/m2.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05966194","url":"https://clinicaltrials.gov/study/NCT05966194"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","oral-cavity-cancer","oropharyngeal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin"],"companies":["epicentrx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05966194","phase":"2","setting":"A Randomized Placebo-Controlled Trial of Two Schedules of RRx-001 for the Attenuation of Severe Oral Mucositis in Patients Receiving Concomitant Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx","sponsor":"EpicentRx, Inc.","started":"2024-04-02","startedType":"actual","enrolled":216,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07662278","kind":"trial","name":"rSIFN-co in Combination With Total Neo-adjuvant Therapy in Subjects With Mid-low Locally Advanced Rectal Cancer","aka":["rSIFN-co"],"tldr":"A phase 2 trial in colorectal cancer, run by Sichuan Huiyang Life Science and Technology Corporation, not yet recruiting.","summary":"rSIFN-co in Combination With Total Neo-adjuvant Therapy in Subjects With Mid-low Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT07662278 by Sichuan Huiyang Life Science and Technology Corporation, with a registry enrolment figure of 90 participants, started 2027-01 and due to reach its primary completion in 2030-01. Interventions recorded: Recombinant Super-Compound Interferon (rSIFN-co); Total Neo-adjuvant therapy. Conditions listed: Mid-low Locally Advanced Rectal Cancer. Primary outcome: To evaluate the complete response rate at the end of treatment period. Colorectal eligibility wording from the registry: \"Subjects with histologically or cytologically confirmed mid-low locally advanced rectal cancer, with tumor location within 12 cm from the anal verge, as per UICC classification, and who are scheduled to undergo TNT in the opinion of the investigator 3\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07662278","url":"https://clinicaltrials.gov/study/NCT07662278"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07662278","phase":"2","setting":"A Randomized, Multi-Center, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Recombinant Super-Compound Interferon (rSIFN-co) in Combination With Total Neo-adjuvant Therapy, in Subjects With Mid-low Locally Advanced Rectal Cancer","sponsor":"Sichuan Huiyang Life Science and Technology Corporation","started":"2027-01","startedType":"estimated","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"rtog-0129","kind":"trial","name":"RTOG 0129 (HPV analysis)","aka":[],"tldr":"The analysis that showed HPV-positive throat cancers are a different, far more curable disease, launching two decades of de-escalation research.","summary":"Ang et al., NEJM 2010: 3-year OS 82.4% for HPV-positive vs 57.1% for HPV-negative oropharyngeal cancer; HPV status was the strongest prognostic factor, with tobacco exposure modifying it. Led to a separate AJCC staging system for HPV-positive disease (8th edition) and the de-escalation trials that followed.","status":"completed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00047008","url":"https://clinicaltrials.gov/study/NCT00047008"},{"label":"NEJM 2010","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa0912217"}],"tags":[],"related":[],"cancers":["head-and-neck","hpv-positive-oropharyngeal-cancer"],"sections":[],"technologies":["imrt-igrt","hpv-vaccine"],"targets":[],"drugs":[],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":["hpv-p16"],"trials":[],"people":["maura-gillison","everett-vokes"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00047008","phase":"3","setting":"Stage III-IV oropharyngeal and other HNSCC: accelerated vs standard fractionation chemoradiation; retrospective HPV analysis","sponsor":"RTOG / NCI","result":"3-year OS 82.4% (HPV+) vs 57.1% (HPV-).","started":"2002-07","startedType":"actual","yearReported":2010,"enrolled":743,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 3 years by HPV status","unit":"%","arms":[{"name":"HPV-positive","value":82.4},{"name":"HPV-negative","value":57.1}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa0912217"}],"replication":"Replicated across TROG, DAHANCA, and De-ESCALaTE cohorts."},{"id":"rtog-0415","kind":"trial","name":"RTOG 0415","aka":["RTOG 0415","NRG Oncology RTOG 0415"],"tldr":"Showed that men with low-risk prostate cancer can have five and a half weeks of radiotherapy instead of eight without losing control of the cancer, at the price of slightly more bowel and bladder trouble later.","summary":"RTOG 0415 randomised 1,115 men with low-risk prostate cancer 1:1 to conventional radiotherapy (73.8 Gy in 41 fractions over 8.2 weeks) or hypofractionated radiotherapy (70 Gy in 28 fractions over 5.6 weeks). The trial was designed to establish that hypofractionation did not reduce 5-year disease-free survival by more than 7.65 percent, a hazard ratio below 1.52.\n\nOf 1,092 protocol-eligible men with follow-up, 542 received conventional and 550 hypofractionated treatment. At a median 5.8 years, estimated 5-year disease-free survival was 85.3 percent (95 percent confidence interval 81.9 to 88.1) with conventional treatment and 86.3 percent (83.1 to 89.0) with hypofractionation, hazard ratio 0.85 (0.64 to 1.14), meeting non-inferiority (p<0.001).\n\nThe cost was measurable: late grade 2 and 3 gastrointestinal and genitourinary adverse events were increased with hypofractionation, hazard ratios 1.31 to 1.59. That is the trade-off hypofractionation has consistently shown, and it is why a man with poor urinary function at baseline is often steered towards a longer course.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00331773","url":"https://clinicaltrials.gov/study/NCT00331773"},{"label":"RTOG 0415 (Journal of Clinical Oncology 2016)","url":"https://doi.org/10.1200/JCO.2016.67.0448"}],"tags":[],"related":[],"cancers":["prostate","prostate-low-risk"],"sections":[],"technologies":["hypofractionated-radiotherapy","imrt-igrt"],"targets":[],"drugs":[],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":["hypofractionation","curative-intent","psa"],"trials":["chhip","profit-trial","hypo-rt-pc","pace-b"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00331773","phase":"3","setting":"Low-risk localised prostate cancer: hypofractionated radiotherapy, 70 Gy in 28 fractions over 5.6 weeks, against conventional radiotherapy, 73.8 Gy in 41 fractions over 8.2 weeks, with 5-year disease-free survival as the primary endpoint and a non-inferiority design","sponsor":"Radiation Therapy Oncology Group, now NRG Oncology, funded by the National Cancer Institute","result":"Five-year disease-free survival 86.3 percent with 70 Gy in 28 fractions against 85.3 percent with 73.8 Gy in 41 fractions (hazard ratio 0.85, 95 percent confidence interval 0.64 to 1.14), non-inferior; late grade 2 to 3 bowel and bladder events increased (hazard ratios 1.31 to 1.59).","started":"2006-04","startedType":"actual","yearReported":2016,"enrolled":1115,"enrolledBasis":"randomised","enrolledNote":"1,115 men were randomised and 1,092 were protocol-eligible with follow-up information; the analysed figure is the one quoted in the results.","outcomes":[{"endpoint":"Disease-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Hypofractionated, 70 Gy in 28 fractions","n":550,"value":86.3},{"name":"Conventional, 73.8 Gy in 41 fractions","n":542,"value":85.3}],"hr":0.85,"ci":[0.64,1.14],"p":"<0.001 for non-inferiority","source":"https://doi.org/10.1200/JCO.2016.67.0448"}],"replication":"CHHiP (3,216 men) and PROFIT (1,206 men) reached the same conclusion for moderate hypofractionation in intermediate-risk disease; HYPO-RT-PC and PACE-B extended it to five or seven fractions."},{"id":"rtog-0617","kind":"trial","name":"RTOG 0617","aka":[],"tldr":"RTOG 0617 is the trial that stopped dose escalation in lung cancer: patients given 74 Gy lived shorter than those given the standard 60 Gy, and cetuximab added nothing.","summary":"RTOG 0617 randomised 544 patients with stage III non-small-cell lung cancer receiving concurrent carboplatin-paclitaxel to 60 Gy or 74 Gy, with or without cetuximab. Median overall survival was 28.7 months with 60 Gy and 20.3 months with 74 Gy; the high-dose arm had more treatment-related deaths and higher heart dose, and cetuximab gave no benefit (Bradley and colleagues, Lancet Oncology 2015). The result fixed 60 Gy as the standard and drew attention to heart dose as a determinant of survival.","status":"negative","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT00533949","url":"https://clinicaltrials.gov/study/NCT00533949"},{"label":"Lancet Oncology 2015","url":"https://doi.org/10.1016/S1470-2045(14)71207-0"}],"tags":["radiation-wave2"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["imrt-igrt","radiosensitisers"],"targets":[],"drugs":["cetuximab","carboplatin","paclitaxel"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":["chemoradiation","organs-at-risk"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-rtog-0617-lancet-oncol-2015"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00533949","phase":"3","setting":"Stage III non-small-cell lung cancer with concurrent chemotherapy: 74 Gy versus 60 Gy, with or without cetuximab","sponsor":"NRG Oncology (RTOG)","result":"Median overall survival 28.7 months (60 Gy) vs 20.3 months (74 Gy); cetuximab no benefit.","started":"2007-11","yearReported":2015,"enrolled":544,"enrolledBasis":"registry","outcomes":[{"endpoint":"Median overall survival","primary":true,"unit":"months","arms":[{"name":"60 Gy","n":217,"value":28.7},{"name":"74 Gy","n":207,"value":20.3}]}]},{"id":"rtog-1016","kind":"trial","name":"RTOG 1016","aka":[],"tldr":"RTOG 1016 tried to spare HPV-positive throat cancer patients the toxicity of cisplatin by using cetuximab instead, and found that survival was worse: cisplatin stays the standard.","summary":"RTOG 1016 randomised 987 patients with HPV-positive oropharyngeal squamous cell carcinoma to accelerated radiotherapy with cisplatin or with cetuximab. Five-year overall survival was 84.6 percent with cisplatin and 77.9 percent with cetuximab, failing non-inferiority, and locoregional failure was higher with cetuximab; overall toxicity was similar (Gillison and colleagues, Lancet 2019). Together with De-ESCALaTE it closed the door on antibody substitution in this good-prognosis disease.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01302834","url":"https://clinicaltrials.gov/study/NCT01302834"},{"label":"Lancet 2019","url":"https://doi.org/10.1016/S0140-6736(18)32779-X"}],"tags":["radiation-wave4"],"related":[],"cancers":["head-and-neck","oropharyngeal-cancer","hpv-positive-oropharyngeal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["cisplatin","cetuximab"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":["chemoradiation","hpv-testing"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01302834","phase":"3","setting":"HPV-positive oropharyngeal cancer: radiotherapy with cetuximab versus radiotherapy with cisplatin","sponsor":"NRG Oncology","result":"5-year overall survival 84.6% (cisplatin) vs 77.9% (cetuximab); non-inferiority not met.","started":"2011-06","startedType":"actual","yearReported":2019,"enrolled":987,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Radiotherapy plus cisplatin","n":406,"value":84.6},{"name":"Radiotherapy plus cetuximab","n":399,"value":77.9}]}]},{"id":"rtog-91-11","kind":"trial","name":"RTOG 91-11","aka":[],"tldr":"RTOG 91-11 established concurrent cisplatin with radiotherapy as the way to keep the voice box in advanced larynx cancer: more patients kept their larynx than with induction chemotherapy or radiotherapy alone, with no loss of survival.","summary":"RTOG 91-11 randomised 547 patients with stage III or IV larynx cancer to induction cisplatin-fluorouracil followed by radiotherapy, concurrent cisplatin with radiotherapy, or radiotherapy alone. At two years the larynx was preserved in 88 percent with concurrent chemoradiation, 75 percent with induction and 70 percent with radiotherapy alone; locoregional control was best with concurrent treatment and overall survival did not differ (Forastiere and colleagues, New England Journal of Medicine 2003). Long-term follow-up showed more non-cancer deaths after concurrent treatment, a caution about late toxicity.","status":"positive","asOf":"2026-09-17","links":[{"label":"NEJM 2003","url":"https://doi.org/10.1056/NEJMoa031317"}],"tags":["radiation-wave4"],"related":[],"cancers":["head-and-neck","laryngeal-cancer"],"sections":[],"technologies":["imrt-igrt","radiosensitisers"],"targets":[],"drugs":["cisplatin","fluorouracil"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":["chemoradiation"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Advanced larynx cancer suitable for larynx preservation: concurrent cisplatin chemoradiation versus induction chemotherapy then radiotherapy versus radiotherapy alone","sponsor":"Radiation Therapy Oncology Group","result":"Larynx preservation at 2 years 88% (concurrent) vs 75% (induction) vs 70% (radiotherapy alone).","yearReported":2003,"enrolled":547,"enrolledBasis":"registry","outcomes":[{"endpoint":"Laryngectomy-free survival driver: larynx preservation at 2 years","primary":true,"unit":"%","arms":[{"name":"Concurrent cisplatin chemoradiation","n":172,"value":88},{"name":"Induction chemotherapy then radiotherapy","n":173,"value":75},{"name":"Radiotherapy alone","n":173,"value":70}]}]},{"id":"rtog-9202","kind":"trial","name":"RTOG 92-02","aka":["RTOG 9202","RTOG 92-02"],"tldr":"Two extra years of hormone therapy after radiotherapy improved every measure of cancer control, but only men with the most aggressive tumours lived longer for it.","summary":"RTOG 92-02 entered 1,554 men with T2c to T4 prostate cancer, no extrapelvic nodes and a PSA below 150. All received 4 months of goserelin and flutamide before and during radiotherapy of 45 Gy to the pelvic nodes and 65 to 70 Gy to the prostate, and were then randomised to no further androgen deprivation or to 24 further months of goserelin. Median follow-up of survivors was 11.3 years.\n\nAt 10 years the long-course arm was better on every endpoint except overall survival: disease-free survival 22.5 against 13.2 percent (p<0.0001), disease-specific survival 88.7 against 83.9 percent (p=0.0042), local progression 12.3 against 22.2 percent (p<0.0001), distant metastasis 14.8 against 22.8 percent (p<0.0001) and biochemical failure 51.9 against 68.1 percent (p at most 0.0001). Overall survival was 53.9 against 51.6 percent, p=0.36.\n\nThe exception was the prespecified subgroup with Gleason 8 to 10 tumours, where overall survival was 45.1 percent with long-course against 31.9 percent with short-course treatment (p=0.0061). That subgroup is why long-course androgen deprivation became the standard for the highest-grade localised disease, and why men with Gleason 7 disease are more often offered a shorter course.","status":"mixed","asOf":"2026-09-25","links":[{"label":"RTOG 92-02 at 10 years (Journal of Clinical Oncology 2008)","url":"https://doi.org/10.1200/JCO.2007.14.9021"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation","imrt-igrt"],"targets":[],"drugs":["goserelin","flutamide"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":["adt","gleason-grade-group","hormone-therapy"],"trials":["eortc-22961","dart-01-05-gicor","rtog-9408"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"T2c to T4 prostate cancer without extrapelvic nodes and PSA below 150: everyone had 4 months of goserelin and flutamide before and during radiotherapy, then randomised to nothing further or to 24 further months of goserelin, reported at 10 years","sponsor":"Radiation Therapy Oncology Group, now NRG Oncology, funded by the National Cancer Institute","result":"At 10 years, 24 extra months of goserelin improved disease-free survival (22.5 against 13.2 percent), disease-specific survival (88.7 against 83.9 percent) and distant metastasis (14.8 against 22.8 percent) but not overall survival (53.9 against 51.6 percent, p=0.36); in Gleason 8 to 10 disease overall survival was 45.1 against 31.9 percent (p=0.0061).","yearReported":2008,"enrolled":1554,"enrolledBasis":"randomised","enrolledNote":"1,554 men were entered; the trial predates ClinicalTrials.gov registration, so there is no registry enrolment figure.","outcomes":[{"endpoint":"Overall survival at 10 years, all patients","primary":true,"unit":"%","arms":[{"name":"Long-course androgen deprivation, 28 months total","value":53.9},{"name":"Short-course androgen deprivation, 4 months","value":51.6}],"p":"0.36","source":"https://doi.org/10.1200/JCO.2007.14.9021"},{"endpoint":"Overall survival at 10 years, Gleason 8 to 10","unit":"%","arms":[{"name":"Long-course androgen deprivation, 28 months total","value":45.1},{"name":"Short-course androgen deprivation, 4 months","value":31.9}],"p":"0.0061","source":"https://doi.org/10.1200/JCO.2007.14.9021"},{"endpoint":"Distant metastasis at 10 years","unit":"%","arms":[{"name":"Long-course androgen deprivation, 28 months total","value":14.8},{"name":"Short-course androgen deprivation, 4 months","value":22.8}],"p":"<0.0001","source":"https://doi.org/10.1200/JCO.2007.14.9021"}],"replication":"EORTC 22961 and DART 01/05 GICOR reached the same conclusion about duration; RTOG 9408 showed the separate point that 4 months added to radiotherapy helps intermediate-risk but not low-risk men."},{"id":"rtog-9408","kind":"trial","name":"RTOG 94-08","aka":["RTOG 9408","RTOG 94-08"],"tldr":"Four months of hormone therapy added to radiotherapy helped men with intermediate-risk prostate cancer live longer, and did nothing for men with low-risk disease.","summary":"RTOG 94-08 randomly assigned 1,979 eligible men with stage T1b to T2b prostate adenocarcinoma and a PSA of 20 or less to radiotherapy alone (992) or radiotherapy with 4 months of total androgen suppression beginning 2 months before radiotherapy (987).\n\nAt a median 9.1 years, 10-year overall survival was 62 percent with combined treatment against 57 percent with radiotherapy alone, hazard ratio for death with radiotherapy alone 1.17, p=0.03. Ten-year disease-specific mortality fell from 8 to 4 percent, hazard ratio 1.87, p=0.001. Biochemical failure, distant metastases and positive repeat biopsy at 2 years all improved.\n\nThe post-hoc risk analysis is what changed practice: the reductions in overall and disease-specific mortality were concentrated in intermediate-risk men, with no significant reduction in low-risk men. That is why a man with low-risk disease having radiotherapy today is usually offered no hormone therapy at all, and a man with intermediate-risk disease is offered 4 to 6 months.\n\nToxicity was modest. Acute and late radiation effects were similar in the two groups and grade 3 or higher hormone-related effects occurred in under 5 percent.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00002597","url":"https://clinicaltrials.gov/study/NCT00002597"},{"label":"RTOG 94-08 (New England Journal of Medicine 2011)","url":"https://doi.org/10.1056/NEJMoa1012348"}],"tags":[],"related":[],"cancers":["prostate","prostate-low-risk","prostate-intermediate-risk"],"sections":[],"technologies":["androgen-deprivation","imrt-igrt"],"targets":[],"drugs":[],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":["adt","curative-intent","hormone-therapy"],"trials":["eortc-22991","rtog-9202","chhip"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002597","phase":"3","setting":"Stage T1b, T1c, T2a or T2b prostate adenocarcinoma with PSA of 20 or less: radiotherapy alone against radiotherapy with 4 months of total androgen suppression starting 2 months before it, with overall survival as the primary endpoint","sponsor":"Radiation Therapy Oncology Group, now NRG Oncology, funded by the National Cancer Institute","result":"Ten-year overall survival 62 against 57 percent (hazard ratio for death with radiotherapy alone 1.17, p=0.03) and disease-specific mortality 4 against 8 percent; benefit confined to intermediate-risk men on post-hoc analysis.","started":"1994-10","yearReported":2011,"enrolled":1979,"enrolledBasis":"randomised","enrolledNote":"1,979 eligible men were randomly assigned between 1994 and 2001.","outcomes":[{"endpoint":"Overall survival at 10 years","primary":true,"unit":"%","arms":[{"name":"Radiotherapy with 4 months of androgen suppression","n":987,"value":62,"note":"Hazard ratio is for death with radiotherapy alone."},{"name":"Radiotherapy alone","n":992,"value":57}],"hr":1.17,"p":"0.03","source":"https://doi.org/10.1056/NEJMoa1012348"},{"endpoint":"Disease-specific mortality at 10 years","unit":"%","arms":[{"name":"Radiotherapy with 4 months of androgen suppression","n":987,"value":4},{"name":"Radiotherapy alone","n":992,"value":8}],"hr":1.87,"p":"0.001","source":"https://doi.org/10.1056/NEJMoa1012348"}],"replication":"EORTC 22991 found the same for 6 months of androgen suppression added to dose-escalated radiotherapy in 819 men, with a biochemical disease-free survival hazard ratio of 0.52."},{"id":"rtog-9402","kind":"trial","name":"RTOG 9402","aka":[],"tldr":"RTOG 9402 looked negative at first and then, with long follow-up, showed that adding PCV chemotherapy to radiotherapy doubles survival in oligodendrogliomas with 1p/19q co-deletion, from about seven to fourteen years.","summary":"RTOG 9402 randomised 291 patients with anaplastic oligodendroglial tumours to four cycles of intensive procarbazine, lomustine and vincristine (PCV) followed by radiotherapy, or radiotherapy alone. Overall survival in the whole group did not differ at first, but in the 1p/19q co-deleted subgroup median survival was 14.7 years with PCV plus radiotherapy versus 7.3 years with radiotherapy alone (Cairncross and colleagues, Journal of Clinical Oncology 2013), a result mirrored by EORTC 26951. Chemoradiation with PCV became standard for co-deleted tumours, and the molecular marker entered the WHO classification.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00002569","url":"https://clinicaltrials.gov/study/NCT00002569"},{"label":"JCO 2013","url":"https://doi.org/10.1200/JCO.2012.43.2674"}],"tags":["radiation-wave4"],"related":[],"cancers":["glioblastoma","brain-tumours","oligodendroglioma"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["lomustine","vincristine","procarbazine"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":["chemoradiation"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002569","phase":"3","setting":"Anaplastic oligodendroglioma and oligoastrocytoma: PCV chemotherapy before radiotherapy versus radiotherapy alone","sponsor":"Radiation Therapy Oncology Group","result":"1p/19q co-deleted: median overall survival 14.7 vs 7.3 years.","started":"1994-07","startedType":"actual","yearReported":2013,"enrolled":291,"enrolledBasis":"registry","outcomes":[{"endpoint":"Median overall survival, 1p/19q co-deleted","primary":true,"unit":"years","arms":[{"name":"PCV then radiotherapy","n":59,"value":14.7},{"name":"Radiotherapy alone","n":67,"value":7.3}]}]},{"id":"rtog-9601","kind":"trial","name":"RTOG 9601","aka":[],"tldr":"RTOG 9601 showed that adding two years of hormone therapy to salvage radiotherapy after prostate surgery lengthens survival, mainly in men with higher PSA levels at relapse.","summary":"RTOG 9601 randomised 760 men with a rising PSA after radical prostatectomy to salvage radiotherapy (64.8 Gy) with 24 months of bicalutamide 150 mg or placebo. Twelve-year overall survival was 76.3 percent with bicalutamide and 71.3 percent with placebo (hazard ratio 0.77), with fewer prostate cancer deaths and metastases; the benefit was concentrated in men with PSA above 0.7 ng/mL, and gynaecomastia was common (Shipley and colleagues, New England Journal of Medicine 2017).","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00002874","url":"https://clinicaltrials.gov/study/NCT00002874"},{"label":"NEJM 2017","url":"https://doi.org/10.1056/NEJMoa1607529"}],"tags":["radiation-wave4"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["bicalutamide"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-rtog-9601-n-engl-j-med-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002874","phase":"3","setting":"Rising PSA after prostatectomy: salvage radiotherapy with two years of bicalutamide versus salvage radiotherapy with placebo","sponsor":"Radiation Therapy Oncology Group","result":"12-year overall survival 76.3% vs 71.3% (hazard ratio 0.77); benefit mainly with PSA above 0.7 ng/mL.","started":"1998-02","yearReported":2017,"enrolled":760,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 12 years","primary":true,"unit":"%","arms":[{"name":"Salvage radiotherapy plus bicalutamide","n":384,"value":76.3},{"name":"Salvage radiotherapy plus placebo","n":376,"value":71.3}]}]},{"id":"ruby","kind":"trial","name":"RUBY / ENGOT-EN6 / GOG-3031","aka":[],"tldr":"Adding immunotherapy to first chemotherapy for advanced endometrial cancer extended life by more than a year on average, most dramatically in tumours with a broken DNA spell-checker.","summary":"In dMMR/MSI-H tumours, 24-month PFS was 61.4% vs 15.7% (HR 0.28); in the overall population PFS HR 0.64 (NEJM 2023). Overall survival in the overall population was 44.6 vs 28.2 months (HR 0.69; Annals of Oncology 2024), with dMMR OS HR 0.32. FDA approval July 2023 (dMMR) and August 2024 (all comers).","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03981796","url":"https://clinicaltrials.gov/study/NCT03981796"},{"label":"NEJM 2023","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2216334"},{"label":"OS, Annals of Oncology 2024","url":"https://www.annalsofoncology.org/article/S0923-7534(24)00721-X/fulltext"}],"tags":[],"related":[],"cancers":["endometrial","endometrial-mmr-deficient","advanced-recurrent-endometrial-cancer","uterine-carcinosarcoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["dostarlimab","carboplatin","paclitaxel"],"companies":["gog-foundation"],"institutions":[],"pathways":[],"terms":["msi"],"trials":[],"people":["mansoor-raza-mirza"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03981796","phase":"3","setting":"Primary advanced (stage III-IV) or first recurrent endometrial cancer: dostarlimab + carboplatin-paclitaxel, then dostarlimab up to 3 years, vs chemotherapy","sponsor":"GSK","result":"OS 44.6 vs 28.2 months overall (HR 0.69); dMMR PFS HR 0.28.","started":"2019-07-18","startedType":"actual","yearReported":2023,"enrolled":494,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 24 months (dMMR/MSI-H)","primary":true,"unit":"%","arms":[{"name":"Dostarlimab + chemo","value":61.4},{"name":"Placebo + chemo","value":15.7}],"hr":0.28,"ci":[0.16,0.5],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2216334"},{"endpoint":"Overall survival (overall population)","primary":true,"unit":"months","arms":[{"name":"Dostarlimab + chemo","n":245,"value":44.6},{"name":"Placebo + chemo","n":249,"value":28.2}],"hr":0.69,"ci":[0.54,0.89],"source":"https://www.annalsofoncology.org/article/S0923-7534(24)00721-X/fulltext"}],"replication":"NRG-GY018/KEYNOTE-868 (pembrolizumab) and DUO-E (durvalumab) reproduced the dMMR effect; RUBY is the only one with a reported all-comers OS benefit so far."},{"id":"rugb","kind":"trial","name":"RUGB","aka":[],"tldr":"RUGB asks whether adding radiotherapy to chemotherapy helps people whose gallbladder cancer cannot be removed but has not spread. It is a 249-patient randomised trial in India, the only phase 2/3 test of radiotherapy in gallbladder cancer alone.","summary":"RUGB (NCT06214572) is an open-label, parallel-arm, integrated phase 2/3 randomised trial at Tata Memorial Centre for histologically proven adenocarcinoma of the gallbladder that is unresectable but non-metastatic, including gallbladder neck primaries with hilar block mimicking hilar cholangiocarcinoma. Patients receive systemic therapy chosen from gemcitabine plus cisplatin, gemcitabine plus oxaliplatin, gemcitabine plus cisplatin plus durvalumab, or gemcitabine plus cisplatin plus nab-paclitaxel, with or without radiotherapy. The primary endpoint is median overall survival; 249 patients are planned, recruitment began in March 2024 and primary completion is listed for July 2029. In the UK the comparable question for locally advanced biliary cancer was addressed by ABC-07, which tested stereotactic radiotherapy after chemotherapy.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06214572","url":"https://clinicaltrials.gov/study/NCT06214572"}],"tags":["india"],"related":[],"cancers":["gallbladder"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","checkpoint-inhibitor"],"targets":[],"drugs":["gemcitabine-cisplatin","gemcitabine","cisplatin","oxaliplatin","durvalumab","nab-paclitaxel"],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":["radiotherapy","chemoradiation"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06214572","phase":"2/3","setting":"Unresectable non-metastatic gallbladder carcinoma: systemic therapy (gemcitabine-cisplatin, gemcitabine-oxaliplatin, gemcitabine-cisplatin-durvalumab or gemcitabine-cisplatin-nab-paclitaxel) with or without radiotherapy","sponsor":"Tata Memorial Centre","started":"2024-03-07","startedType":"actual","enrolled":249,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06243458","kind":"trial","name":"RVU120 for Treatment of Anemia in Patients With Lower-risk Myelodysplastic Neoplasms","aka":[],"tldr":"A phase 2 trial of RVU120 (SEL120) in myelodysplastic syndromes / neoplasms, run by GCP-Service International West GmbH, active and no longer recruiting.","summary":"RVU120 for Treatment of Anemia in Patients With Lower-risk Myelodysplastic Neoplasms is a phase 2 interventional study registered as NCT06243458 by GCP-Service International West GmbH, with 41 participants enrolled, started 2024-09-10 and due to reach its primary completion in 2026-05. Interventions recorded: RVU120 (SEL120).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06243458","url":"https://clinicaltrials.gov/study/NCT06243458"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mds","mds-lower-risk"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ryvu-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06243458","phase":"2","setting":"A Phase II, Open-label, Multicenter Study of Orally Administered RVU120 for the Treatment of Anemia in Patients With Lower-risk Myelodysplastic Neoplasms (MDS)","sponsor":"GCP-Service International West GmbH","started":"2024-09-10","startedType":"actual","enrolled":41,"enrolledBasis":"registry","outcomes":[]},{"id":"rxponder","kind":"trial","name":"RxPONDER (SWOG S1007)","aka":[],"tldr":"Postmenopausal women with a few positive lymph nodes and a low gene-test score can skip chemotherapy; premenopausal women still benefit from it.","summary":"RxPONDER, SWOG trial S1007, NCT01272037, sponsored by SWOG and the NCI and reported in 2020, showed that postmenopausal women with one to three positive lymph nodes and a low Oncotype DX recurrence score can skip chemotherapy, while premenopausal women still benefit from it. Among 5,083 women with HR-positive, HER2-negative disease and scores of 25 or below, chemotherapy added nothing to endocrine therapy in the 3,350 postmenopausal women but improved invasive disease-free survival in the 1,665 premenopausal women, a benefit possibly mediated by chemotherapy-induced ovarian suppression. OnCo links it to Oncotype DX, the ovarian function suppression term, the gene-assay-to-chemotherapy-omission pairing, Kathy S. Albain and Kevin Kalinsky. Whether ovarian suppression alone could replace chemotherapy in younger women is being tested in NRG-BR009, known as OFSET.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01272037","url":"https://clinicaltrials.gov/study/NCT01272037"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":["gene-expression-prognostic-assays","rna-seq"],"targets":[],"drugs":["oncotype-dx"],"companies":["swog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["kathy-albain","kevin-kalinsky"],"bottlenecks":[],"keyPapers":["paper-rxponder-n-engl-j-med-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01272037","phase":"3","setting":"HR+/HER2- breast cancer with 1-3 positive nodes and recurrence score ≤25: endocrine therapy alone vs chemo-endocrine therapy","sponsor":"SWOG / NCI","result":"No chemo benefit postmenopausal; iDFS HR 0.60 with chemo premenopausal.","started":"2011-02-28","startedType":"actual","yearReported":2020,"enrolled":5018,"enrolledBasis":"registry","outcomes":[{"endpoint":"5-year iDFS, postmenopausal","primary":true,"unit":"%","arms":[{"name":"Endocrine alone","value":91.9},{"name":"Chemo-endocrine","value":91.3}],"hr":1.02,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2108873"},{"endpoint":"5-year iDFS, premenopausal","primary":true,"unit":"%","arms":[{"name":"Endocrine alone","value":89},{"name":"Chemo-endocrine","value":93.9}],"hr":0.6,"ci":[0.43,0.83],"source":"https://doi.org/10.1056/NEJMoa2108873"}],"replication":"Consistent with TAILORx age interaction; the OFS-vs-chemotherapy question is being tested prospectively (NRG-BR009 / OFSET)."},{"id":"nct05101070","kind":"trial","name":"S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors","aka":["aCCeleR8-001"],"tldr":"A phase 1/2 trial of Pembrolizumab and Bevacizumab in advanced solid tumours, run by Shionogi, now recruiting.","summary":"S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05101070 by Shionogi, with 282 participants planned, started 2022-05-30 and due to reach its primary completion in 2028-05-31. Interventions recorded: S-531011, Pembrolizumab and Bevacizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05101070","url":"https://clinicaltrials.gov/study/NCT05101070"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","bevacizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05101070","phase":"1/2","setting":"A Phase 1b/2, Multicenter, Open-label Study of S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors","sponsor":"Shionogi","started":"2022-05-30","startedType":"actual","enrolled":282,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01349881","kind":"trial","name":"S0820, Adenoma and Second Primary Prevention Trial","aka":["PACES"],"tldr":"A phase 3 trial of eflornithine (DFMO) in colorectal cancer, run by SWOG Cancer Research Network, active but no longer recruiting.","summary":"S0820, Adenoma and Second Primary Prevention Trial is a phase 3, randomised interventional study registered as NCT01349881 by SWOG Cancer Research Network, with a registry enrolment figure of 354 participants, started 2013-08-23 and due to reach its primary completion in 2027-09-15. Interventions recorded: Eflornithine placebo & sulindac placebo; eflornithine & sulindac placebo; Eflornithine placebo & sulindac; Eflornithine plus sulindac. Conditions listed: Colorectal Neoplasms. Primary outcome: Event rate, defined as rate of high-risk adenoma or second primary colorectal cancer (CRC). Colorectal eligibility wording from the registry: \"* History of Stage 0-III colon or rectal cancer with primary resection 1 year previously\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01349881","url":"https://clinicaltrials.gov/study/NCT01349881"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["eflornithine"],"companies":["cancer-prevention-pharmaceuticals","swog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01349881","phase":"3","setting":"A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES)","sponsor":"SWOG Cancer Research Network","started":"2013-08-23","startedType":"actual","enrolled":354,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06188702","kind":"trial","name":"S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP","aka":[],"tldr":"A phase 1/2 trial of TNG462 in advanced solid tumours, run by Servier Bio-Innovation LLC, active and no longer recruiting.","summary":"S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP is a phase 1/2 interventional study registered as NCT06188702 by Servier Bio-Innovation LLC, with 60 participants enrolled, started 2024-04-29 and due to reach its primary completion in 2027-05-01. Interventions recorded: S095035 and TNG462.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06188702","url":"https://clinicaltrials.gov/study/NCT06188702"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tng462"],"companies":["tango-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06188702","phase":"1/2","setting":"A Phase 1/2, Open-label, Multicenter Clinical Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Antineoplastic Activity of S095035 (MAT2A Inhibitor) as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Homozygous Deletion of MTAP","sponsor":"Servier Bio-Innovation LLC","started":"2024-04-29","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04155034","kind":"trial","name":"S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cel","aka":["MAVERICK"],"tldr":"A phase 3 trial in lung cancer, run by SWOG Cancer Research Network, active but no longer recruiting.","summary":"S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT04155034 by SWOG Cancer Research Network, with a registry enrolment figure of 668 participants, started 2020-05-04 and due to reach its primary completion in 2026-03-17. Interventions recorded: Magnetic Resonance Imaging; Prophylactic Cranial Irradiation. Conditions listed: Extensive Stage Lung Small Cell Carcinoma; Limited Stage Lung Small Cell Carcinoma; Lung Small Cell Carcinoma. Primary outcome: Overall survival (OS). Lung eligibility wording from the registry: \"* Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC)\". Sites: Canada, Chile, Colombia, Mexico, Saudi Arabia, South Korea, United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04155034","url":"https://clinicaltrials.gov/study/NCT04155034"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["limited-stage-sclc","extensive-stage-sclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["swog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04155034","phase":"3","setting":"MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)","sponsor":"SWOG Cancer Research Network","started":"2020-05-04","startedType":"actual","enrolled":668,"enrolledBasis":"registry","outcomes":[]},{"id":"sabr-comet","kind":"trial","name":"SABR-COMET: stereotactic ablative radiotherapy for oligometastatic cancer","aka":[],"tldr":"The randomised trial that made treating a handful of metastases with pinpoint radiotherapy respectable: survival was longer with SABR, and at five years more than twice as many patients were alive.","summary":"Ninety-nine patients with one to five metastases were randomised between palliative standard of care and standard of care plus stereotactic ablative radiotherapy to all sites. The 2019 Lancet report showed longer overall survival with SABR; the 2020 long-term update reported five-year overall survival of 42.3 percent with SABR against 17.7 percent with standard care. Grade 5 toxicity occurred in the SABR arm, and the phase 3 successors SABR-COMET-3 and SABR-COMET-10 are testing the approach in one to three and four to ten metastases.","status":"positive","asOf":"2026-09-16","links":[{"label":"Palma et al., SABR-COMET (Lancet 2019)","url":"https://doi.org/10.1016/S0140-6736(18)32487-5"},{"label":"Long-term results (JCO 2020)","url":"https://doi.org/10.1200/JCO.20.00818"},{"label":"ClinicalTrials.gov NCT01446744","url":"https://clinicaltrials.gov/study/NCT01446744"}],"tags":["owner-request"],"related":[],"cancers":["metastatic-cancer","breast-hr-positive","nsclc","colorectal","prostate"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-palma-j-clin-oncol","paper-sabr-comet-lancet-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01446744","phase":"2","setting":"Controlled primary and one to five metastases, any solid tumour: standard palliative care alone versus standard care plus stereotactic ablative radiotherapy to every metastasis; ten centres, 99 randomised 1:2","sponsor":"London Health Sciences Centre (Palma)","result":"5-year OS 42.3% vs 17.7% (long-term update, JCO 2020).","started":"2011-11","yearReported":2019,"enrolled":99,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 5 years","primary":false,"unit":"percent","arms":[{"name":"SABR + standard care","n":66,"value":42.3},{"name":"Standard care","n":33,"value":17.7}],"source":"https://doi.org/10.1200/JCO.20.00818"}]},{"id":"nct07623577","kind":"trial","name":"Sac-TMT Combined With Bevacizumab in TNBC With Brain Metastases","aka":[],"tldr":"A phase 2 trial of sacituzumab tirumotecan and bevacizumab in triple-negative breast cancer, run by Fudan University, now recruiting.","summary":"Sac-TMT Combined With Bevacizumab in TNBC With Brain Metastases is a phase 2, interventional study registered as NCT07623577 by Fudan University, with a registry enrolment figure of 24 participants, started 2026-01-01 and due to reach its primary completion in 2027-01. Interventions recorded: Sacituzumab Tirumotecan (Sac-TMT); bevacizumab. Conditions listed: TNBC; Brain Metastasis. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07623577","url":"https://clinicaltrials.gov/study/NCT07623577"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","brain-metastases"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-tirumotecan","bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07623577","phase":"2","setting":"An Open-label, Single-arm, Multi-center Phase II Study of Sacituzumab Tirumotecan (Sac-TMT) Combined With Bevacizumab in Triple-negative Breast Cancer Patients With Brain Metastases","sponsor":"Fudan University","started":"2026-01-01","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07244874","kind":"trial","name":"Sac-TMT Combined With Toripalimab for First-line Treatment of PD-L1 Positive a/mTNBC","aka":[],"tldr":"A phase 2 trial of sacituzumab tirumotecan and toripalimab in triple-negative breast cancer, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"Sac-TMT Combined With Toripalimab for First-line Treatment of PD-L1 Positive a/mTNBC is a phase 2, interventional study registered as NCT07244874 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 41 participants, started 2025-12-01 and due to reach its primary completion in 2028-01-30. Interventions recorded: Sacituzumab tirumotecan; Toripalimab. Conditions listed: TNBC - Triple-Negative Breast Cancer; PD-L1 Positive. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07244874","url":"https://clinicaltrials.gov/study/NCT07244874"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["sacituzumab-tirumotecan","toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07244874","phase":"2","setting":"A Single Arm, Phase II Study of Sacituzumab Tirumotecan（Sac-TMT） Combined With Toripalimab for First-line Treatment of PD-L1 Positive Unresectable Locally Advanced/Metastatic Triple Negative Breast Cancer (a/mTNBC)","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2025-12-01","startedType":"estimated","enrolled":41,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07458113","kind":"trial","name":"Sac-TMT for Active TNBC Brain Metastases","aka":["BERLIN"],"tldr":"A phase 2 trial of sacituzumab tirumotecan in triple-negative breast cancer, run by Yale University, not yet recruiting.","summary":"Sac-TMT for Active TNBC Brain Metastases is a phase 2, interventional study registered as NCT07458113 by Yale University, with a registry enrolment figure of 20 participants, started 2026-08 and due to reach its primary completion in 2028-08. Interventions recorded: Sacituzumab tirumotecan. Conditions listed: Metastatic Triple Negative Breast Cancers. Triple-negative eligibility wording from the registry: \"Histologically and/or cytologically confirmed metastatic triple-negative breast cancer defined by estrogen receptor (ER) expression \\<10%, progesterone receptor expression \\<10% and HER2-negative status, defined by 0, 1+ or 2+ FISH negative by immunohistochemistry (IHC) by standard pathology\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07458113","url":"https://clinicaltrials.gov/study/NCT07458113"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic","brain-metastases"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-tirumotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07458113","phase":"2","setting":"Sacituzumab Tirumotecan to Treat Patients With Brain Metastases From Triple-negative Breast Cancer","sponsor":"Yale University","started":"2026-08","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07628504","kind":"trial","name":"Sac-TMT Sequential Capecitabine Versus Capecitabine in Early-Stage High-Risk Triple-Negative Breast Cancer Without BRCA Mutations","aka":["STARTER"],"tldr":"A phase 3 trial of sacituzumab tirumotecan and capecitabine in triple-negative breast cancer, run by Fudan University, not yet recruiting.","summary":"Sac-TMT Sequential Capecitabine Versus Capecitabine in Early-Stage High-Risk Triple-Negative Breast Cancer Without BRCA Mutations is a phase 3, randomised interventional study registered as NCT07628504 by Fudan University, with a registry enrolment figure of 420 participants, started 2026-05-18 and due to reach its primary completion in 2030-03-30. Interventions recorded: Sacituzumab Tirumotecan (sac-TMT); Capecitabine. Conditions listed: Adjuvant Drug Therapy. Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07628504","url":"https://clinicaltrials.gov/study/NCT07628504"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy"],"targets":[],"drugs":["sacituzumab-tirumotecan","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07628504","phase":"3","setting":"Sacituzumab Tirumotecan (Sac-TMT) Sequential Capecitabine Versus Capecitabine as Adjuvant Regimen for Triple-Negative Breast Cancer With Early-Stage, High-Risk, Non-BRCA Mutated Status: A Phase III, Randomized, Controlled, Open-Label, Multicenter Clinical Trial","sponsor":"Fudan University","started":"2026-05-18","startedType":"estimated","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06963905","kind":"trial","name":"Saci Nivo Rela for TNBC","aka":["SIMONE"],"tldr":"A phase 1/2 trial of nivolumab and sacituzumab govitecan in triple-negative breast cancer, run by Yale University, now recruiting.","summary":"Saci Nivo Rela for TNBC is a phase 1/2, randomised interventional study registered as NCT06963905 by Yale University, with a registry enrolment figure of 60 participants, started 2025-12-29 and due to reach its primary completion in 2030-12. Interventions recorded: Relatlimab FDC + Nivolumab; Sacituzumab Govitecan (SG); Nivolumab. Conditions listed: Metastatic Triple-negative Breast Cancer. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06963905","url":"https://clinicaltrials.gov/study/NCT06963905"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","sacituzumab-govitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06963905","phase":"1/2","setting":"Phase Ib Randomized Open-label Trial of Sacituzumab Govitecan Plus Nivolumab or Sacituzumab Govitecan Plus Nivolumab and Relatlimab as Second-line Therapy for Patients With Metastatic Triple Negative Breast Cancer","sponsor":"Yale University","started":"2025-12-29","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04468061","kind":"trial","name":"Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC","aka":[],"tldr":"A phase 2 trial of sacituzumab govitecan and pembrolizumab in triple-negative breast cancer, run by Dana-Farber Cancer Institute, now recruiting.","summary":"Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC is a phase 2, randomised interventional study registered as NCT04468061 by Dana-Farber Cancer Institute, with a registry enrolment figure of 110 participants, started 2020-07-20 and due to reach its primary completion in 2027-04-01. Interventions recorded: Sacituzumab Govitecan; Pembrolizumab. Conditions listed: Breast Cancer; Triple Negative Breast Cancer; PD-L1 Negative. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04468061","url":"https://clinicaltrials.gov/study/NCT04468061"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["sacituzumab-govitecan","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04468061","phase":"2","setting":"Saci-IO TNBC: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC)","sponsor":"Dana-Farber Cancer Institute","started":"2020-07-20","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06401824","kind":"trial","name":"Sacituzumab Govitecan and Bevacizumab for NSCLC Brain Metastases","aka":[],"tldr":"A phase 2 trial of bevacizumab in lung cancer, run by Maastricht University Medical Center, now recruiting.","summary":"Sacituzumab Govitecan and Bevacizumab for NSCLC Brain Metastases is a phase 2, interventional study registered as NCT06401824 by Maastricht University Medical Center, with a registry enrolment figure of 25 participants, started 2025-04-24 and due to reach its primary completion in 2026-11-01. Interventions recorded: Sacituzumab Govitecan-Hziy 180 MG plus bevacizumab. Conditions listed: NSCLC Stage IV; Brain Metastases, Adult. Primary outcome: brain metastases overall response rate (ORR). Lung eligibility wording from the registry: \"Pathology proven metastatic non-squamous NSCLC\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06401824","url":"https://clinicaltrials.gov/study/NCT06401824"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06401824","phase":"2","setting":"A Single Arm Phase II Study Evaluating Intracranial Efficacy of Sacituzumab Govitecan (SG) With Bevacizumab in Patients With Active, Asymptomatic Brain Metastases From Non-small Cell Lung Cancer (NSCLC)","sponsor":"Maastricht University Medical Center","started":"2025-04-24","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07788222","kind":"trial","name":"Sacituzumab Govitecan and Q901 in Advanced TNBC","aka":[],"tldr":"A phase 2 trial of sacituzumab govitecan in triple-negative breast cancer, run by Yonsei University, not yet recruiting.","summary":"Sacituzumab Govitecan and Q901 in Advanced TNBC is a phase 2, interventional study registered as NCT07788222 by Yonsei University, with a registry enrolment figure of 48 participants, started 2026-09-01 and due to reach its primary completion in 2028-05-31. Interventions recorded: Sacituzumab govitecan and Q901. Conditions listed: Triple Negative Breast Neoplasms. Triple-negative eligibility wording from the registry: \"Patients with histologically or cytologically confirmed triple-negative breast cancer (TNBC) who have received at least 2 prior lines of systemic anticancer therapy for recurrent, metastatic, or unresectable disease\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07788222","url":"https://clinicaltrials.gov/study/NCT07788222"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07788222","phase":"2","setting":"Multi-center, Open-label, Single-arm Phase II Clinical Trial of Sacituzumab-Govitecan Plus Q901 in Advanced TNBC","sponsor":"Yonsei University","started":"2026-09-01","startedType":"estimated","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06238921","kind":"trial","name":"Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases","aka":["TARGET-TNBC"],"tldr":"A phase 1/2 trial of zimberelimab and sacituzumab govitecan in triple-negative breast cancer, run by H. Lee Moffitt Cancer Center and Research Institute, now recruiting.","summary":"Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases is a phase 1/2, interventional study registered as NCT06238921 by H. Lee Moffitt Cancer Center and Research Institute, with a registry enrolment figure of 31 participants, started 2024-12-19 and due to reach its primary completion in 2027-02. Interventions recorded: Stereotactic Radiation; Zimberelimab; Sacituzumab govitecan. Conditions listed: Breast Cancer; Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Triple negative breast cancer; to fulfill the requirement of triple negative disease, a breast cancer must express (≤ 10%), by immunohistochemistry (IHC), of the hormone receptors (estrogen receptor \\[ER\\] and progesterone receptor \\[PR\\])\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06238921","url":"https://clinicaltrials.gov/study/NCT06238921"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic","brain-metastases"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["zimberelimab","sacituzumab-govitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06238921","phase":"1/2","setting":"Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases (TARGET-TNBC)","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","started":"2024-12-19","startedType":"actual","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06243393","kind":"trial","name":"Sacituzumab Govitecan in Metastatic Colorectal Cancer","aka":["TROPHIT1"],"tldr":"A phase 2/3 trial of sacituzumab govitecan in colorectal cancer, run by University Hospital Heidelberg, now recruiting.","summary":"Sacituzumab Govitecan in Metastatic Colorectal Cancer is a phase 2/3, randomised interventional study registered as NCT06243393 by University Hospital Heidelberg, with a registry enrolment figure of 80 participants, started 2024-04-19 and due to reach its primary completion in 2028-08-01. Interventions recorded: Sacituzumab Govitecan (SG); Physicians Choice (PhC).. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Progression Free Survival (PFS). Colorectal eligibility wording from the registry: \"Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy\". Sites: Germany. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06243393","url":"https://clinicaltrials.gov/study/NCT06243393"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06243393","phase":"2/3","setting":"A Randomized, Open Label, Multicenter Phase II/III Trial of Sacituzumab Govitecan Compared to Standard of Care in Metastatic, Refractory Colorectal Cancer Patients","sponsor":"University Hospital Heidelberg","started":"2024-04-19","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04595565","kind":"trial","name":"Sacituzumab Govitecan in Primary HER2-negative Breast Cancer","aka":["SASCIA"],"tldr":"A phase 3 trial of capecitabine, carboplatin, cisplatin and sacituzumab govitecan in triple-negative breast cancer, run by GBG Forschungs GmbH, active but no longer recruiting.","summary":"Sacituzumab Govitecan in Primary HER2-negative Breast Cancer is a phase 3, randomised interventional study registered as NCT04595565 by GBG Forschungs GmbH, with a registry enrolment figure of 1332 participants, started 2020-10-28 and due to reach its primary completion in 2027-03-30. Interventions recorded: Capecitabine; Carboplatin; Cisplatin; Sacituzumab govitecan. Conditions listed: HER2-negative Breast Cancer; Triple Negative Breast Cancer. Sites: Austria, Belgium, France, Germany, Ireland, Spain, Switzerland. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04595565","url":"https://clinicaltrials.gov/study/NCT04595565"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["capecitabine","carboplatin","cisplatin","sacituzumab-govitecan"],"companies":["gbg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04595565","phase":"3","setting":"Phase III Postneoadjuvant Study Evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in Primary HER2-negative Breast Cancer Patients With High Relapse Risk After Standard Neoadjuvant Treatment - SASCIA","sponsor":"GBG Forschungs GmbH","started":"2020-10-28","startedType":"actual","enrolled":1332,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04230109","kind":"trial","name":"Sacituzumab Govitecan In TNBC","aka":["NeoSTAR"],"tldr":"A phase 2 trial of sacituzumab govitecan and pembrolizumab in triple-negative breast cancer, run by Massachusetts General Hospital, now recruiting.","summary":"Sacituzumab Govitecan In TNBC is a phase 2, interventional study registered as NCT04230109 by Massachusetts General Hospital, with a registry enrolment figure of 239 participants, started 2020-07-14 and due to reach its primary completion in 2028-10. Interventions recorded: Sacituzumab Govitecan; Pembrolizumab. Conditions listed: Invasive Breast Cancer; Triple Negative Breast Cancer; ER-Negative Breast Cancer; PR-Negative Breast Cancer; HER2-negative Breast Cancer. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04230109","url":"https://clinicaltrials.gov/study/NCT04230109"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["sacituzumab-govitecan","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04230109","phase":"2","setting":"A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR)","sponsor":"Massachusetts General Hospital","started":"2020-07-14","startedType":"actual","enrolled":239,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07359404","kind":"trial","name":"Sacituzumab Govitecan Plus Bevacizumab in Metastatic TNBC","aka":[],"tldr":"A phase 2 trial of sacituzumab govitecan and bevacizumab in triple-negative breast cancer, run by YING FAN, now recruiting.","summary":"Sacituzumab Govitecan Plus Bevacizumab in Metastatic TNBC is a phase 2, interventional study registered as NCT07359404 by YING FAN, with a registry enrolment figure of 60 participants, started 2024-04-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: Sacituzumab Govitecan (SG); Bevacizumab. Conditions listed: Advanced Breast Cancer. Triple-negative eligibility wording from the registry: \"Pathologically confirmed recurrent or metastatic Triple-Negative Breast Cancer (TNBC)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07359404","url":"https://clinicaltrials.gov/study/NCT07359404"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-govitecan","bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07359404","phase":"2","setting":"A Phase II Clinical Study of Sacituzumab Govitecan Combined With Bevacizumab for the Treatment of Patients With Metastatic Triple-Negative Breast Cancer","sponsor":"YING FAN","started":"2024-04-01","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06170788","kind":"trial","name":"Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With P","aka":["TroFuse-007"],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007) is a phase 3 interventional study registered as NCT06170788 by Merck Sharp & Dohme LLC, with 614 participants planned, started 2023-12-15 and due to reach its primary completion in 2028-01-25. Interventions recorded: Sacituzumab tirumotecan, Pembrolizumab, Supportive care measures. Conditions listed: Non-small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06170788","url":"https://clinicaltrials.gov/study/NCT06170788"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pdl1-high-nsclc"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06170788","phase":"3","setting":"A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50% (TroFuse-007)","sponsor":"Merck Sharp & Dohme LLC","started":"2023-12-15","startedType":"actual","enrolled":614,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06132958","kind":"trial","name":"Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)","aka":["ENGOT-en23"],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Doxorubicin, Paclitaxel / nab-paclitaxel in endometrial cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005) is a phase 3 interventional study registered as NCT06132958 by Merck Sharp & Dohme LLC, with 710 participants planned, started 2023-12-06 and due to reach its primary completion in 2028-01-10. Interventions recorded: Sacituzumab tirumotecan, Doxorubicin, Paclitaxel, Nab-paclitaxel, Rescue medications. Conditions listed: Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06132958","url":"https://clinicaltrials.gov/study/NCT06132958"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","doxorubicin","paclitaxel"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06132958","phase":"3","setting":"A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)","sponsor":"Merck Sharp & Dohme LLC","started":"2023-12-06","startedType":"actual","enrolled":710,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06393374","kind":"trial","name":"Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)","aka":[],"tldr":"A phase 3 trial of Pembrolizumab, Sacituzumab tirumotecan and Capecitabine in triple-negative breast cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012) is a phase 3 interventional study registered as NCT06393374 by Merck Sharp & Dohme LLC, with 1530 participants planned, started 2024-06-24 and due to reach its primary completion in 2030-12-16. Interventions recorded: Pembrolizumab, Sacituzumab tirumotecan and Capecitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06393374","url":"https://clinicaltrials.gov/study/NCT06393374"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":[],"drugs":["pembrolizumab","sacituzumab-tirumotecan","capecitabine"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06393374","phase":"3","setting":"A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery","sponsor":"Merck Sharp & Dohme LLC","started":"2024-06-24","startedType":"actual","enrolled":1530,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06074588","kind":"trial","name":"Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With","aka":[],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Docetaxel, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004) is a phase 3 interventional study registered as NCT06074588 by Merck Sharp & Dohme LLC, with 556 participants planned, started 2023-11-12 and due to reach its primary completion in 2027-05-10. Interventions recorded: Sacituzumab tirumotecan, Docetaxel, Pemetrexed. Conditions listed: Non-small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06074588","url":"https://clinicaltrials.gov/study/NCT06074588"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","docetaxel","pemetrexed"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06074588","phase":"3","setting":"A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations","sponsor":"Merck Sharp & Dohme LLC","started":"2023-11-12","startedType":"actual","enrolled":556,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06305754","kind":"trial","name":"Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, A","aka":[],"tldr":"A phase 3 trial of Sacituzumab tirumotecan, Pemetrexed, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009) is a phase 3 interventional study registered as NCT06305754 by Merck Sharp & Dohme LLC, with 550 participants planned, started 2024-06-11 and due to reach its primary completion in 2028-08-17. Interventions recorded: Sacituzumab tirumotecan, Pemetrexed, Carboplatin, H1 Receptor Antagonist, H2 Receptor Antagonist. Conditions listed: Non-small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06305754","url":"https://clinicaltrials.gov/study/NCT06305754"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","pemetrexed","carboplatin","dexamethasone"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06305754","phase":"3","setting":"A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors","sponsor":"Merck Sharp & Dohme LLC","started":"2024-06-11","startedType":"actual","enrolled":550,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07561463","kind":"trial","name":"Sacituzumab Tirumotecan for Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of sacituzumab tirumotecan in pancreatic cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, not yet recruiting.","summary":"Sacituzumab Tirumotecan for Pancreatic Cancer is a phase 2, interventional study registered as NCT07561463 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 30 participants, started 2026-04-01 and due to reach its primary completion in 2027-01-01. Interventions recorded: Sacituzumab tirumotecan. Conditions listed: Pancreatic Ductal Adenocarcinoma (PDAC). Primary outcome: Objective Response Rate (ORR). Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (including adenosquamous carcinoma)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07561463","url":"https://clinicaltrials.gov/study/NCT07561463"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-tirumotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07561463","phase":"2","setting":"A Phase II Trial of Sacituzumab Tirumotecan for Previously Treated Locally Advanced or Metastatic Pancreatic Cancer","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2026-04-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07501169","kind":"trial","name":"Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC)","aka":["STAR-01"],"tldr":"A phase 2 trial of sacituzumab tirumotecan and anlotinib in lung cancer, run by Sichuan University, not yet recruiting.","summary":"Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC) is a phase 2, interventional study registered as NCT07501169 by Sichuan University, with a registry enrolment figure of 33 participants, started 2026-04-01 and due to reach its primary completion in 2027-08-31. Interventions recorded: Sacituzumab Tirumotecan and Anlotinib. Conditions listed: Extensive-stage Small Cell Lung Cancer (ES-SCLC). Primary outcome: Objective Response Rate (ORR). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed small cell lung cancer (SCLC) based on pathology and immunohistochemistry/immunophenotyping results; disease staged as extensive-stage SCLC (ES-SCLC) according to the Veterans Administration Lung Study Group (VALG) staging system\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07501169","url":"https://clinicaltrials.gov/study/NCT07501169"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["adc","antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan","anlotinib"],"companies":["kelun-biotech","sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07501169","phase":"2","setting":"Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC): A Prospective, Single-Arm, Phase II Study (STAR-01)","sponsor":"Sichuan University","started":"2026-04-01","startedType":"estimated","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07007780","kind":"trial","name":"Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC","aka":[],"tldr":"A phase 2 trial of sacituzumab tirumotecan in triple-negative breast cancer, run by Xijing Hospital, not yet recruiting.","summary":"Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC is a phase 2, interventional study registered as NCT07007780 by Xijing Hospital, with a registry enrolment figure of 35 participants, started 2025-08-20 and due to reach its primary completion in 2026-08-31. Interventions recorded: Sacituzumab Tirumotecan. Conditions listed: Triple -Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"TNBC Confirmation: Confirmed as TNBC based on histology and/or cytology, and meeting the following criteria:\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07007780","url":"https://clinicaltrials.gov/study/NCT07007780"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-tirumotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07007780","phase":"2","setting":"A Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC","sponsor":"Xijing Hospital","started":"2025-08-20","startedType":"estimated","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07324629","kind":"trial","name":"Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma","aka":[],"tldr":"A phase 2 trial of Sacituzumab tirumotecan in thymoma and thymic carcinoma, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma is a phase 2 interventional study registered as NCT07324629 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 30 participants planned, started 2026-03-13 and due to reach its primary completion in 2028-04. Interventions recorded: Sacituzumab tirumotecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07324629","url":"https://clinicaltrials.gov/study/NCT07324629"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["thymic-epithelial","thymic-carcinoma"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-tirumotecan"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07324629","phase":"2","setting":"A Phase II Clinical Study of Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma With Treatment Failure After Platinum-Based Therapy","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-03-13","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07701122","kind":"trial","name":"Sacituzumab Tirumotecan in Previously Treated TROP2-Positive Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of sacituzumab tirumotecan in gallbladder cancer and other biliary tract cancers, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, not yet recruiting.","summary":"Sacituzumab Tirumotecan in Previously Treated TROP2-Positive Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT07701122 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 33 participants, started 2026-07-01 and due to reach its primary completion in 2027-07-01. Interventions recorded: Sacituzumab Tirumotecan (SKB264). Conditions listed: Advanced Biliary Tract Cancer(BTC). No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07701122","url":"https://clinicaltrials.gov/study/NCT07701122"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-tirumotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07701122","phase":"2","setting":"A Single-Arm, Phase II, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan as Second-Line or Later Therapy in Patients With TROP2-Positive Advanced Biliary Tract Cancer","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2026-07-01","startedType":"estimated","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07139470","kind":"trial","name":"Sacituzumab Tirumotecan Plus Anlotinib for Metastatic Triple Negative Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of sacituzumab tirumotecan and anlotinib in triple-negative breast cancer, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"Sacituzumab Tirumotecan Plus Anlotinib for Metastatic Triple Negative Breast Cancer is a phase 1/2, interventional study registered as NCT07139470 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 59 participants, started 2025-08-15 and due to reach its primary completion in 2027-04-15. Interventions recorded: Sacituzumab Tirumotecan + anlotinib. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Histologically and/or cytologically confirmed triple-negative breast cancer (TNBC) based on the most recent biopsy or pathological specimen, including:\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07139470","url":"https://clinicaltrials.gov/study/NCT07139470"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-tirumotecan","anlotinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07139470","phase":"1/2","setting":"An Open-label, Single-arm, Multicenter Phase I/II Study of Sacituzumab Tirumotecan (Sac-TMT) Plus Anlotinib in Previously Treated Metastatic Triple Negative Breast Cancer (mTNBC).","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2025-08-15","startedType":"estimated","enrolled":59,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07153965","kind":"trial","name":"Sacituzumab Tirumotecan Plus Tagitanlimab in Previously Treated Locally Advanced or Metastatic Triple Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of sacituzumab tirumotecan in triple-negative breast cancer, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"Sacituzumab Tirumotecan Plus Tagitanlimab in Previously Treated Locally Advanced or Metastatic Triple Negative Breast Cancer is a phase 2, interventional study registered as NCT07153965 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 47 participants, started 2025-09-01 and due to reach its primary completion in 2026-09-01. Interventions recorded: Sacituzumab Tirumotecan plus Tagitanlimab. Conditions listed: Triple Negative Breast Cancer (TNBC); PD-L1 Positive. Triple-negative eligibility wording from the registry: \"* Histologically and/or cytologically confirmed triple-negative breast cancer (TNBC) based on the most recent biopsy or other pathological specimens, including:\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07153965","url":"https://clinicaltrials.gov/study/NCT07153965"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-tirumotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07153965","phase":"2","setting":"An Open-label, Single-arm, Multicenter Phase II Study of Sacituzumab Tirumotecan (Sac-TMT) Plus Tagitanlimab in Previously Treated PD-L1-positive Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2025-09-01","startedType":"estimated","enrolled":47,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07343479","kind":"trial","name":"Sacituzumab Tirumotecan Plus Third-Generation TKI With/Without Radiotherapy for EGFR-Mutant NSCLC Brain Metastases","aka":[],"tldr":"A phase 2 trial of sacituzumab tirumotecan in lung cancer, run by Zhejiang Cancer Hospital, not yet recruiting.","summary":"Sacituzumab Tirumotecan Plus Third-Generation TKI With/Without Radiotherapy for EGFR-Mutant NSCLC Brain Metastases is a phase 2, interventional study registered as NCT07343479 by Zhejiang Cancer Hospital, with a registry enrolment figure of 45 participants, started 2026-05-01 and due to reach its primary completion in 2027-06-20. Interventions recorded: sac-TMT plus EGFR-TKI. Conditions listed: NSCLC (Advanced Non-small Cell Lung Cancer); EGFR Gene Mutations; Brain Metastasis. Primary outcome: 6-month PFS rate. Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed non-squamous NSCLC, and metastatic (Stage IV);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07343479","url":"https://clinicaltrials.gov/study/NCT07343479"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["adc","imrt-igrt"],"targets":[],"drugs":["sacituzumab-tirumotecan"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07343479","phase":"2","setting":"A Clinical Study of Sac-TMT for Injection Combined With Third-Generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) ± Radiotherapy in Subjects With EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer and Brain Metastasis Who Have Failed Prior EGFR-TKI Treatment","sponsor":"Zhejiang Cancer Hospital","started":"2026-05-01","startedType":"estimated","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06937177","kind":"trial","name":"Safely Optimizing Body Weight With Mifomelatide (TCMCB07) in Patients With Newly Diagnosed Colorectal Cancer (CRC) or Pancreatic Ductal Adenocarcinoma (PDAC) Undergoing Chemotherapy","aka":[],"tldr":"A phase 2 trial of TCMCB07 in colorectal cancer, run by Endevica Bio, now recruiting.","summary":"Safely Optimizing Body Weight With Mifomelatide (TCMCB07) in Patients With Newly Diagnosed Colorectal Cancer (CRC) or Pancreatic Ductal Adenocarcinoma (PDAC) Undergoing Chemotherapy is a phase 2 interventional study registered as NCT06937177 by Endevica Bio, with 120 participants planned, started 2025-04-28 and due to reach its primary completion in 2027-10. Interventions recorded: TCMCB07 and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06937177","url":"https://clinicaltrials.gov/study/NCT06937177"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06937177","phase":"2","setting":"Safely Optimizing Body Weight With Mifomelatide (TCMCB07) in Patients With Newly Diagnosed Colorectal Cancer (CRC) or Pancreatic Ductal Adenocarcinoma (PDAC) Undergoing Chemotherapy","sponsor":"Endevica Bio","started":"2025-04-28","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03668639","kind":"trial","name":"Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin","aka":[],"tldr":"A phase 2/3 trial of Netupitant and palonosetron and Dexamethasone in Cervical cancer, run by Christina Ruhlmann, with a status the registry has not verified recently.","summary":"Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin is a phase 2/3 interventional study registered as NCT03668639 by Christina Ruhlmann, with 80 participants planned, started 2018-09-05 and due to reach its primary completion in 2023-03-01. Interventions recorded: Akynzeo, Dexamethasone. Conditions recorded: Chemotherapy-induced Nausea and Vomiting, Adverse Event, Cervical Cancer.\n\nLinked to the drug Netupitant and palonosetron because the registry names it among its interventions and Cervical cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03668639","url":"https://clinicaltrials.gov/study/NCT03668639"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cervical"],"sections":[],"technologies":[],"targets":[],"drugs":["netupitant-palonosetron","dexamethasone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03668639","phase":"2/3","setting":"A Study to Investigate the Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone in Patients Receiving Concomitant Chemo-radiotherapy With Weekly Cisplatin for at Least Five Weeks","sponsor":"Christina Ruhlmann","started":"2018-09-05","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06474806","kind":"trial","name":"Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer","aka":["uTRACE-101"],"tldr":"A phase 2 trial of 64Cu-DOTA-AE105 in prostate cancer, run by Curasight, now recruiting.","summary":"Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer is a phase 2 interventional study registered as NCT06474806 by Curasight, with 168 participants planned, started 2024-06-01 and due to reach its primary completion in 2027-01-30. Interventions recorded: 64Cu-DOTA-AE105.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06474806","url":"https://clinicaltrials.gov/study/NCT06474806"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["pet"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06474806","phase":"2","setting":"An Open-label, Two-part, Phase 2 Clinical Trial to Investigate the Safety and Diagnostic Performance of uPAR PET Imaging for Non-invasive Classification of ISUP Grades Among Patients With Localised, Untreated Prostate Cancer.","sponsor":"Curasight","started":"2024-06-01","startedType":"actual","enrolled":168,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07095309","kind":"trial","name":"Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/ III Colorectal Cancer","aka":["NeoART-M"],"tldr":"A phase 2 trial in colorectal cancer, run by Metanoic Health Ltd., not yet recruiting.","summary":"Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/ III Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07095309 by Metanoic Health Ltd., with a registry enrolment figure of 120 participants, started 2025-08-15 and due to reach its primary completion in 2032-08-30. Interventions recorded: Artesunate; Artesunate matching Placebo. Conditions listed: Stage II/III Colon Cancer; Bowel Cancer. Primary outcome: Recurrence-Free Survival (RFS) at 2 Years Post-Randomisation Assessed by Radiological and Clinical Evaluation. Colorectal eligibility wording from the registry: \"* Histologically proven single primary site colorectal adenocarcinoma or high grade dysplasia plus unequivocal radiological evidence of invasive cancer\". Sites: Malaysia. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07095309","url":"https://clinicaltrials.gov/study/NCT07095309"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07095309","phase":"2","setting":"Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer","sponsor":"Metanoic Health Ltd.","started":"2025-08-15","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05552001","kind":"trial","name":"Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer","aka":["ISIdE"],"tldr":"A phase 3 trial of sacituzumab govitecan in triple-negative breast cancer, run by UNICANCER, active but no longer recruiting.","summary":"Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer is a phase 3, interventional study registered as NCT05552001 by UNICANCER, with a registry enrolment figure of 96 participants, started 2023-10-05 and due to reach its primary completion in 2026-10-01. Interventions recorded: Sacituzumab govitecan. Conditions listed: Triple Negative Breast Cancer; Metastatic Breast Cancer. Triple-negative eligibility wording from the registry: \"Patients with pathologically documented locally advanced inoperable or metastatic triple negative breast cancer (mTNBC) whose disease has progressed on (neo)adjuvant chemotherapy+/-immunotherapy for early TNBC or within 6 months after the end of any systemic therapy, surgery or radiotherapy with cur\". Sites: France. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05552001","url":"https://clinicaltrials.gov/study/NCT05552001"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05552001","phase":"3","setting":"ISIdE: Open Label, Multicentric, Single-arm Phase IIIB Trial to Evaluate the Safety and Efficacy of Sacituzumab Govitecan in Triple Negative Metastatic Breast Cancer Patients With a Biomarker Analysis","sponsor":"UNICANCER","started":"2023-10-05","startedType":"actual","enrolled":96,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00630032","kind":"trial","name":"Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer","aka":["TavIx"],"tldr":"A phase 3 trial of Cyclophosphamide, Docetaxel, Epirubicin, Fluorouracil and Ixabepilone in Breast cancer, run by UNICANCER, completed.","summary":"Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer is a phase 3 interventional study registered as NCT00630032 by UNICANCER, with 762 participants recorded, started 2007-09 and reaching its primary completion in 2017-06. Interventions recorded: cyclophosphamide, Docetaxel, epirubicin hydrochloride, fluorouracil, ixabepilone. Conditions recorded: Breast Cancer.\n\nLinked to the drug Ixabepilone because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00630032","url":"https://clinicaltrials.gov/study/NCT00630032"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cyclophosphamide","docetaxel","epirubicin","fluorouracil","ixabepilone"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00630032","phase":"3","setting":"Randomized, Open Label, Multicentric Phase III Evaluating the Benefit of a Sequential Regimen Associating FEC 100 and Ixabepilone in Adjuvant Treatment of Non Metastatic, Poor Prognosis Breast Cancer Defined as Triple-negative Tumor [HER2 Negative - ER Negative - PR Negative] or [HER2 Negative and PR Negative] Tumor; in Node Positive or Node Negative Patients.","sponsor":"UNICANCER","started":"2007-09","startedType":"actual","yearReported":2021,"enrolled":762,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Disease-free Survival (DFS)","primary":true,"unit":"%","arms":[{"name":"Docetaxel","n":398,"value":78.97,"note":"95% CI 74.53 to 82.73; Figures from the ClinicalTrials.gov results section (first posted 2021-03-16), not from a publication"},{"name":"Ixabepilone","n":364,"value":83.37,"note":"95% CI 79.06 to 86.87"}],"hr":0.8,"ci":[0.59,1.1],"p":"0.175","source":"https://clinicaltrials.gov/study/NCT00630032?tab=results"},{"endpoint":"Overall Survival","unit":"%","arms":[{"name":"Docetaxel","n":398,"value":87,"note":"95% CI 83.13 to 90.03; Figures from the ClinicalTrials.gov results section (first posted 2021-03-16), not from a publication"},{"name":"Ixabepilone","n":364,"value":87.6,"note":"95% CI 83.64 to 90.66"}],"hr":0.97,"ci":[0.67,1.42],"p":"0.8968","source":"https://clinicaltrials.gov/study/NCT00630032?tab=results"}]},{"id":"nct05558007","kind":"trial","name":"Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients","aka":[],"tldr":"A phase 2 trial of Tadalafil 5mg in prostate cancer, run by Biozeus Biopharmaceutical S.A., now recruiting.","summary":"Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients is a phase 2 interventional study registered as NCT05558007 by Biozeus Biopharmaceutical S.A., with 72 participants planned, started 2023-11-22 and due to reach its primary completion in 2024-12-31. Interventions recorded: Tadalafil 5mg, BZ371A, Oral Placebo and Topical Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05558007","url":"https://clinicaltrials.gov/study/NCT05558007"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05558007","phase":"2","setting":"Phase 2 Clinical Trial to Evaluate Safety and Efficacy of BZ371A in a Gel Applied in Patients That Performed Radical Prostatectomy","sponsor":"Biozeus Biopharmaceutical S.A.","started":"2023-11-22","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04416984","kind":"trial","name":"Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2)","aka":["ALPHA2"],"tldr":"A phase 1/2 trial of ALLO-647, Fludarabine and Cyclophosphamide in chronic lymphocytic leukaemia, run by Allogene Therapeutics, active and no longer recruiting.","summary":"Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2) is a phase 1/2 interventional study registered as NCT04416984 by Allogene Therapeutics, with 160 participants enrolled, started 2020-05-21 and due to reach its primary completion in 2029-02. Interventions recorded: ALLO-501A, ALLO-647, Fludarabine and Cyclophosphamide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04416984","url":"https://clinicaltrials.gov/study/NCT04416984"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":[],"targets":[],"drugs":["allo-647","fludarabine","cyclophosphamide"],"companies":["allogene"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04416984","phase":"1/2","setting":"A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma (LBCL)","sponsor":"Allogene Therapeutics","started":"2020-05-21","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05312710","kind":"trial","name":"Safety and Efficacy of APG-157 in Head and Neck Cancer","aka":[],"tldr":"A phase 2 trial of APG-157 in head and neck squamous cell carcinoma, run by Aveta Biomics, Inc., active and no longer recruiting.","summary":"Safety and Efficacy of APG-157 in Head and Neck Cancer is a phase 2 interventional study registered as NCT05312710 by Aveta Biomics, Inc., with 24 participants enrolled, started 2022-04-22 and due to reach its primary completion in 2026-12. Interventions recorded: APG-157.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05312710","url":"https://clinicaltrials.gov/study/NCT05312710"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","oral-cavity-cancer","oropharyngeal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["aveta-biomics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05312710","phase":"2","setting":"Phase 2 Study to Evaluate the Safety and Efficacy of APG-157 as Neoadjuvant/Induction Therapy for Patients With Head and Neck Squamous Cell Cancer (HNSCC) of the Oral Cavity and/or Oropharynx","sponsor":"Aveta Biomics, Inc.","started":"2022-04-22","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07387926","kind":"trial","name":"Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)","aka":[],"tldr":"A phase 1/2 trial of Asciminib, Dexamethasone, Vincristine, Blinatumomab, Methotrexate and Cytarabine in acute lymphoblastic leukaemia, run by Novartis Pharmaceuticals, now recruiting.","summary":"Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL) is a phase 1/2 interventional study registered as NCT07387926 by Novartis Pharmaceuticals, with 50 participants planned, started 2026-07-05 and due to reach its primary completion in 2033-09-19. Interventions recorded: Asciminib Adult formulation, Asciminib Pediatric formulation, Dexamethasone, Vincristine, Blinatumomab and Methotrexate (intrathecal).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07387926","url":"https://clinicaltrials.gov/study/NCT07387926"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","all-paediatric-relapsed","all-ph-like"],"sections":[],"technologies":["kinase-inhibitors","t-cell-engager"],"targets":[],"drugs":["asciminib","dexamethasone","vincristine","blinatumomab","methotrexate","cytarabine"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07387926","phase":"1/2","setting":"Open-label, Phase I/II Study to Evaluate Safety and Efficacy of Asciminib With Chemotherapy Followed by Asciminib Plus Blinatumomab in Pediatric, Adolescent, and Young Adults With Relapsed or Refractory BCR::ABL1-positive (Philadelphia Positive, Ph+) or BCR::ABL1-like (Ph-like) ALL","sponsor":"Novartis Pharmaceuticals","started":"2026-07-05","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06712355","kind":"trial","name":"Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of PM8002, Atezolizumab, Etoposide in small-cell lung cancer, run by BioNTech SE, now recruiting.","summary":"Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer is a phase 3 interventional study registered as NCT06712355 by BioNTech SE, with 621 participants planned, started 2025-02-03 and due to reach its primary completion in 2028-12. Interventions recorded: Pumitamig, Atezolizumab, Etoposide, Carboplatin (or cisplatin if carboplatin is not tolerated). Conditions listed: Extensive-stage Small-cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06712355","url":"https://clinicaltrials.gov/study/NCT06712355"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["pm8002","atezolizumab","etoposide","carboplatin"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06712355","phase":"3","setting":"A Phase III, Multisite, Double-blinded Randomized Trial of BNT327 in Combination With Chemotherapy (Etoposide/Carboplatin) Compared to Atezolizumab in Combination With Chemotherapy (Etoposide/Carboplatin) in Participants With First-line Extensive-stage Small-cell Lung Cancer","sponsor":"BioNTech SE","started":"2025-02-03","startedType":"actual","enrolled":621,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00434148","kind":"trial","name":"Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease","aka":[],"tldr":"A phase 3 trial of Pasireotide in Pituitary tumours, run by Novartis Pharmaceuticals, completed.","summary":"Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease is a phase 3 interventional study registered as NCT00434148 by Novartis Pharmaceuticals, with 162 participants recorded, started 2006-12 and reaching its primary completion in 2010-03. Interventions recorded: Pasireotide. Conditions recorded: Cushing's Disease.\n\nLinked to the drug Pasireotide because the registry names it among its interventions and Pituitary tumours among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00434148","url":"https://clinicaltrials.gov/study/NCT00434148"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pituitary-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["pasireotide"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00434148","phase":"3","setting":"A Randomized, Double-blind Study to Assess the Safety and Efficacy of Different Dose Levels of Pasireotide (SOM230) Subcutaneous (sc) Over a 6 Month Treatment Period in Patients With de Novo, Persistent or Recurrent Cushing's Disease","sponsor":"Novartis Pharmaceuticals","started":"2006-12","yearReported":2013,"enrolled":162,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group","primary":true,"unit":"participants","arms":[{"name":"Pasireotide 600 ug","n":82,"value":12,"note":"95% CI 7.0 to 22.3; Figures from the ClinicalTrials.gov results section (first posted 2013-02-06), not from a publication"},{"name":"Pasireotide 900 ug","n":80,"value":21,"note":"95% CI 16.6 to 35.9"}],"source":"https://clinicaltrials.gov/study/NCT00434148?tab=results"}]},{"id":"nct06697301","kind":"trial","name":"Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma","aka":["TeLuRide-006"],"tldr":"A phase 2/3 trial testing EIK1001 in melanoma, now recruiting.","summary":"Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma is a phase 2/3 interventional study registered as NCT06697301, led by Eikon Therapeutics with Merck Sharp & Dohme, and recruiting on the registry. Official title: A Multicenter, Randomised, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants With Advanced Melanoma (TeLuRide-006). Planned enrolment is 740 participants (estimated). The study started in 2025-05-22 and primary completion is expected in 2035-12. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06697301","url":"https://clinicaltrials.gov/study/NCT06697301"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["eik1001"],"companies":["eikon-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06697301","phase":"2/3","setting":"A Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants With Advanced Melanoma (TeLuRide-006)","sponsor":"Eikon Therapeutics","started":"2025-05-22","startedType":"actual","enrolled":740,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05704244","kind":"trial","name":"Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)","aka":[],"tldr":"A phase 3 trial of FE 999326 in bladder & urothelial cancer, run by Ferring Pharmaceuticals, active and no longer recruiting.","summary":"Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC) is a phase 3 interventional study registered as NCT05704244 by Ferring Pharmaceuticals, with 25 participants enrolled, started 2022-12-21 and due to reach its primary completion in 2029-11-30. Interventions recorded: FE 999326.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05704244","url":"https://clinicaltrials.gov/study/NCT05704244"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ferring"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05704244","phase":"3","setting":"A Phase 3, Open Label Trial to Evaluate the Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)","sponsor":"Ferring Pharmaceuticals","started":"2022-12-21","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06685276","kind":"trial","name":"Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of fruquintinib, sintilimab and tucidinostat (chidamide) in colorectal cancer, run by Dai, Guanghai, now recruiting.","summary":"Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06685276 by Dai, Guanghai, with a registry enrolment figure of 46 participants, started 2024-08-16 and due to reach its primary completion in 2025-12. Interventions recorded: Fruquintinib; Sintilimab; Chidamide. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Progress-free Survival(PFS). Colorectal eligibility wording from the registry: \"Patients with histologically confirmed unresectable locally advanced, recurrent, or metastatic colorectal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06685276","url":"https://clinicaltrials.gov/study/NCT06685276"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib","sintilimab","tucidinostat"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06685276","phase":"2","setting":"A Prospective Single-arm Phase Ib/II Study on the Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer","sponsor":"Dai, Guanghai","started":"2024-08-16","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06947291","kind":"trial","name":"Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors","aka":[],"tldr":"A phase 2 trial of Glumetinib and Docetaxel in gastric & gastro-oesophageal junction cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., now recruiting.","summary":"Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors is a phase 2 interventional study registered as NCT06947291 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., with 350 participants planned, started 2025-06-04 and due to reach its primary completion in 2027-04-30. Interventions recorded: Glumetinib Tablets and Docetaxel for Injection (Albumin-bound).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06947291","url":"https://clinicaltrials.gov/study/NCT06947291"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["glumetinib","docetaxel"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06947291","phase":"2","setting":"A Multicenter, Open-label, Phase II Clinical Study to Evaluate the Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors With MET Overexpression and/or Amplification","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","started":"2025-06-04","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07471789","kind":"trial","name":"Safety and Efficacy of GYA01 (CART84) in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Acute Lymphoblastic T Leukemia Patients (T-ALL).","aka":[],"tldr":"A phase 1/2 trial of CART84 in acute myeloid leukaemia, run by Gyala Therapeutics, now recruiting.","summary":"Safety and Efficacy of GYA01 (CART84) in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Acute Lymphoblastic T Leukemia Patients (T-ALL). is a phase 1/2 interventional study registered as NCT07471789 by Gyala Therapeutics, with 33 participants planned, started 2026-02-04 and due to reach its primary completion in 2029-05-31. Interventions recorded: CART84.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07471789","url":"https://clinicaltrials.gov/study/NCT07471789"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":["cart84"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07471789","phase":"1/2","setting":"Phase I/IIa Clinical Trial With Dose Escalation to Evaluate Safety and Efficacy of the Infusion of CART84 in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Acute Lymphoblastic T Leukemia Patients (T-ALL).","sponsor":"Gyala Therapeutics","started":"2026-02-04","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06771622","kind":"trial","name":"Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Trastuzumab, Pertuzumab, Oxaliplatin, Capecitabine, Ramucirumab and Bevacizumab in advanced solid tumours, run by FBD Biologics Limited, active and no longer recruiting.","summary":"Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06771622 by FBD Biologics Limited, with 500 participants enrolled, started 2025-03-13 and due to reach its primary completion in 2028-01-01. Interventions recorded: HCB101, Trastuzumab, Pertuzumab, Oxaliplatin, Capecitabine and Ramucirumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06771622","url":"https://clinicaltrials.gov/study/NCT06771622"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["trastuzumab","pertuzumab","oxaliplatin","capecitabine","ramucirumab","bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06771622","phase":"1/2","setting":"Phase Ib/IIa, Open-label, Multicenter, Dose Escalation, and Dose Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of HCB101 in Combination With Multiple Agents in Subjects With Advanced Solid Tumors","sponsor":"FBD Biologics Limited","started":"2025-03-13","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07150247","kind":"trial","name":"Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of iparomlimab and tuvonralimab, bevacizumab (glioblastoma use), fluorouracil (5-FU) and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT07150247 by Sun Yat-sen University, with a registry enrolment figure of 20 participants, started 2025-06-01 and due to reach its primary completion in 2027-06-30. Interventions recorded: Iparomlimab and Tuvonralimab; Bevacizumab; 5-Fluorouracil; Irinotecan (drug). Conditions listed: BRAF V600 Colorectal Cancer. Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed metastatic colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07150247","url":"https://clinicaltrials.gov/study/NCT07150247"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","braf-v600e-colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["iparomlimab-tuvonralimab","bevacizumab-glioma","fluorouracil","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07150247","phase":"2","setting":"A Phase II Single-Arm Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer","sponsor":"Sun Yat-sen University","started":"2025-06-01","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04262466","kind":"trial","name":"Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors","aka":[],"tldr":"A phase 1/2 trial of Brenetafusp, Pembrolizumab, Tebentafusp and Bevacizumab in advanced solid tumours, run by Immunocore Ltd, active and no longer recruiting.","summary":"Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors is a phase 1/2 interventional study registered as NCT04262466 by Immunocore Ltd, with 410 participants enrolled, started 2020-02-25 and due to reach its primary completion in 2026-10. Interventions recorded: Brenetafusp, Brenetafusp and pembrolizumab, Brenetafusp and chemotherapy, Brenetafusp and monoclonal antibodies and chemotherapy, Brenetafusp and tebentafusp and Brenetafusp and bevacizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04262466","url":"https://clinicaltrials.gov/study/NCT04262466"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["brenetafusp","pembrolizumab","tebentafusp","bevacizumab"],"companies":["immunocore"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04262466","phase":"1/2","setting":"Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers","sponsor":"Immunocore Ltd","started":"2020-02-25","startedType":"actual","enrolled":410,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04969731","kind":"trial","name":"Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 3 trial of Gemcitabine in pancreatic ductal adenocarcinoma, run by GC Cell Corporation, now recruiting.","summary":"Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer is a phase 3 interventional study registered as NCT04969731 by GC Cell Corporation, with 408 participants planned, started 2021-09-07 and due to reach its primary completion in 2026-12. Interventions recorded: Immuncell-LC, Gemcitabine. Conditions listed: Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04969731","url":"https://clinicaltrials.gov/study/NCT04969731"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":["gc-cell"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04969731","phase":"3","setting":"An Open-label, Randomized, Multi-center, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Immuncell-LC Therapy Combined With Gemcitabine Versus Adjuvant Gemcitabine Single Therapy After Resection in Patients With Pancreatic Ductal Adenocarcinoma","sponsor":"GC Cell Corporation","started":"2021-09-07","startedType":"actual","enrolled":408,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06506643","kind":"trial","name":"Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms","aka":[],"tldr":"A phase 1/2 trial of Zinc-64 Aspartate in advanced solid tumours, run by Vector Vitale LLC, now recruiting.","summary":"Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms is a phase 1/2 interventional study registered as NCT06506643 by Vector Vitale LLC, with 36 participants planned, started 2024-05-15 and due to reach its primary completion in 2028-12-31. Interventions recorded: Zinc-64 Aspartate.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06506643","url":"https://clinicaltrials.gov/study/NCT06506643"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06506643","phase":"1/2","setting":"A Phase I/II Open-label Multicenter Dose Escalation and Dose Expansion Study to Evaluate the Safety and Efficacy of KLS-1 as Monotherapy in Patients With Malignant Neoplasms","sponsor":"Vector Vitale LLC","started":"2024-05-15","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04502394","kind":"trial","name":"Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL","aka":[],"tldr":"A phase 1/2 trial of KRT-232, Acalabrutinib in diffuse large b-cell lymphoma and hodgkin lymphoma, run by Kartos Therapeutics, Inc., now recruiting.","summary":"Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL is a phase 1/2 interventional study registered as NCT04502394 by Kartos Therapeutics, Inc., with 84 participants planned, started 2021-02-23 and due to reach its primary completion in 2022-10. Interventions recorded: KRT-232, acalabrutinib. Conditions listed: Diffuse Large B Cell Lymphoma, Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04502394","url":"https://clinicaltrials.gov/study/NCT04502394"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl","hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["krt-232","acalabrutinib"],"companies":["kartos-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04502394","phase":"1/2","setting":"An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma or Relapsed/Refractory Chronic Lymphocytic Leukemia","sponsor":"Kartos Therapeutics, Inc.","started":"2021-02-23","startedType":"actual","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04443010","kind":"trial","name":"Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma","aka":["GLIOSUN"],"tldr":"A phase 1/2 trial of Temozolomide in glioma & glioblastoma, run by Philogen S.p.A., now recruiting.","summary":"Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma is a phase 1/2 interventional study registered as NCT04443010 by Philogen S.p.A., with 226 participants planned, started 2021-01-20 and due to reach its primary completion in 2026-10. Interventions recorded: Onfekafusp alfa and Temozolomide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04443010","url":"https://clinicaltrials.gov/study/NCT04443010"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":["philogen-s-p-a"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04443010","phase":"1/2","setting":"A Study to Evaluate the Safety and Efficacy of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF Plus Standard Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma","sponsor":"Philogen S.p.A.","started":"2021-01-20","startedType":"actual","enrolled":226,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01331239","kind":"trial","name":"Safety and Efficacy of LCI699 in Cushing's Disease Patients","aka":[],"tldr":"A phase 2 trial of Osilodrostat in Pituitary tumours, run by Novartis Pharmaceuticals, completed.","summary":"Safety and Efficacy of LCI699 in Cushing's Disease Patients is a phase 2 interventional study registered as NCT01331239 by Novartis Pharmaceuticals, with 31 participants recorded, started 2011-03-23 and reaching its primary completion in 2019-10-22. Interventions recorded: LCI699. Conditions recorded: Cushings Disease, Cushing Disease.\n\nLinked to the drug Osilodrostat because the registry names it among its interventions and Pituitary tumours among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01331239","url":"https://clinicaltrials.gov/study/NCT01331239"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pituitary-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["osilodrostat"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01331239","phase":"2","setting":"A Proof of Concept, Open-label, Forced Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of 10-weeks Treatment of LCI699 in Patients With Cushing's Disease","sponsor":"Novartis Pharmaceuticals","started":"2011-03-23","startedType":"actual","yearReported":2021,"enrolled":31,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Responders to LCI699 Based on the Change in Mean Urinary Free Cortisol (UFC) From Baseline to Week 10","primary":true,"unit":"%","arms":[{"name":"Part l: Core Cohort","n":9,"value":100,"note":"Figures from the ClinicalTrials.gov results section (first posted 2021-01-22), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01331239?tab=results"}]},{"id":"nct04888312","kind":"trial","name":"Safety and Efficacy of Mitazalimab in Combination With Chemotherapy in Pancreatic Cancer Patients","aka":["OPTIMIZE-1"],"tldr":"A phase 1/2 trial of CD40 agonist mitazalimab in combination with chemotherapy in pancreatic ductal adenocarcinoma, run by Alligator Bioscience AB, active and no longer recruiting.","summary":"Safety and Efficacy of Mitazalimab in Combination With Chemotherapy in Pancreatic Cancer Patients is a phase 1/2 interventional study registered as NCT04888312 by Alligator Bioscience AB, with 94 participants enrolled, started 2021-09-17 and due to reach its primary completion in 2026-06-01. Interventions recorded: CD40 agonist mitazalimab in combination with chemotherapy.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04888312","url":"https://clinicaltrials.gov/study/NCT04888312"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["mitazalimab"],"companies":["alligator-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04888312","phase":"1/2","setting":"An Open-label Phase 1b/2 Study Assessing the Safety and Efficacy of Mitazalimab in Combination With Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma","sponsor":"Alligator Bioscience AB","started":"2021-09-17","startedType":"actual","enrolled":94,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07745790","kind":"trial","name":"Safety and Efficacy of Multimodal Thermal Therapy (MTT) Combined With KRAS G12V mRNA Vaccine, S-1, and Sintilimab in Patients With Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of sintilimab and tegafur, gimeracil and oteracil (S-1) in pancreatic cancer, run by Ruijin Hospital, not yet recruiting.","summary":"Safety and Efficacy of Multimodal Thermal Therapy (MTT) Combined With KRAS G12V mRNA Vaccine, S-1, and Sintilimab in Patients With Metastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT07745790 by Ruijin Hospital, with a registry enrolment figure of 20 participants, started 2026-07-13 and due to reach its primary completion in 2029-07-31. Interventions recorded: Multimodal Thermal Therapy (MTT) System; KRAS G12V mRNA Vaccine; Sintilimab; S-1. Conditions listed: Pancreatic Ductal Adenocarcinoma; Liver Neoplasms; Lung Neoplasms. Primary outcome: Incidence and Severity of Adverse Events (CTCAE v6.0); Frequency of Dose Modifications and Treatment Discontinuations. Pancreatic eligibility wording from the registry: \"* Patients with advanced pancreatic cancer or postoperative recurrent pancreatic cancer confirmed by histopathological or cytological examination\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07745790","url":"https://clinicaltrials.gov/study/NCT07745790"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","neoantigen-mrna-vaccine"],"targets":[],"drugs":["sintilimab","tegafur-gimeracil-oteracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07745790","phase":"2","setting":"A Study of Multimodal Thermal Therapy (MTT) Combined With KRAS G12V mRNA Vaccine, S-1, and Sintilimab for Safety and Efficacy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Disease Progression After or Are Intolerant to Standard First-Line Therapy","sponsor":"Ruijin Hospital","started":"2026-07-13","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06047379","kind":"trial","name":"Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis","aka":[],"tldr":"A phase 1/2 trial of Ipilimumab, Pembrolizumab, Nivolumab in cervical cancer and colorectal cancer, run by Neonc Technologies, Inc., now recruiting.","summary":"Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis is a phase 1/2 interventional study registered as NCT06047379 by Neonc Technologies, Inc., with 134 participants planned, started 2023-11-01 and due to reach its primary completion in 2027-02-28. Interventions recorded: NEO212 Oral Capsule, Ipilimumab, Pembrolizumab, Nivolumab, Regorafenib. Conditions listed: Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype, Brain Metastases, Adult, Cervical Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06047379","url":"https://clinicaltrials.gov/study/NCT06047379"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","colorectal","head-and-neck","melanoma","merkel-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["ipilimumab","pembrolizumab","nivolumab","regorafenib","carboplatin","paclitaxel"],"companies":["neonc-technologies"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06047379","phase":"1/2","setting":"An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients With Select Solid Tumors.","sponsor":"Neonc Technologies, Inc.","started":"2023-11-01","startedType":"actual","enrolled":134,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06060613","kind":"trial","name":"Safety and Efficacy of OBX-115 in Advanced Solid Tumors","aka":["Agni-01"],"tldr":"A phase 1/2 trial of OBX-115 in melanoma and non-small-cell lung cancer, run by Obsidian Therapeutics, Inc., now recruiting.","summary":"Safety and Efficacy of OBX-115 in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06060613 by Obsidian Therapeutics, Inc., with 208 participants planned, started 2023-10-25 and due to reach its primary completion in 2029-06-30. Interventions recorded: OBX-115.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06060613","url":"https://clinicaltrials.gov/study/NCT06060613"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["obsidian-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06060613","phase":"1/2","setting":"A Phase 1/2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) In Participants With Advanced Solid Tumors","sponsor":"Obsidian Therapeutics, Inc.","started":"2023-10-25","startedType":"actual","enrolled":208,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00600886","kind":"trial","name":"Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly","aka":[],"tldr":"A phase 3 trial of Pasireotide and Somatostatin analogues in Pituitary tumours, run by Novartis Pharmaceuticals, completed.","summary":"Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly is a phase 3 interventional study registered as NCT00600886 by Novartis Pharmaceuticals, with 358 participants recorded, started 2008-02-11 and reaching its primary completion in 2016-03-11. Interventions recorded: Pasireotide, Octreotide. Conditions recorded: Acromegaly.\n\nLinked to the drug Pasireotide because the registry names it among its interventions and Pituitary tumours among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00600886","url":"https://clinicaltrials.gov/study/NCT00600886"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pituitary-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["pasireotide","octreotide-lanreotide"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00600886","phase":"3","setting":"A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly","sponsor":"Novartis Pharmaceuticals","started":"2008-02-11","startedType":"actual","yearReported":2015,"enrolled":358,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1, Overall","primary":true,"unit":"%","arms":[{"name":"Pasireotide LAR (Core)","n":176,"value":31.3,"note":"95% CI 24.5 to 38.7; Figures from the ClinicalTrials.gov results section (first posted 2015-01-30), not from a publication"},{"name":"Octreotide LAR (Core)","n":182,"value":19.2,"note":"95% CI 13.8 to 25.7"}],"p":"0.007","source":"https://clinicaltrials.gov/study/NCT00600886?tab=results"}]},{"id":"nct06002789","kind":"trial","name":"Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC is a phase 2, interventional study registered as NCT06002789 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 17 participants, started 2022-05-01 and due to reach its primary completion in 2027-09-01. Interventions recorded: MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy; All-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapy. Conditions listed: Multiple Cancer; Colorectal Cancer. Primary outcome: pCR rate. Colorectal eligibility wording from the registry: \"Histological confirmation of simultaneous multiple primary colorectal cancer (sMPCC);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06002789","url":"https://clinicaltrials.gov/study/NCT06002789"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06002789","phase":"2","setting":"Safety and Efficacy of PD-1 Monoclonal Antibody With or Without mFOLFOX6 Neoadjuvant Therapy in Patients With Local Advanced Deficient Mismatch Repair/Microsatellite Instability-high Synchronous Multiple Primary Colorectal Cancer (sMPCC)","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2022-05-01","startedType":"actual","enrolled":17,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03407144","kind":"trial","name":"Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","aka":["KEYNOTE 667"],"tldr":"A phase 2 trial of Pembrolizumab, Doxorubicin, Vinblastine in hodgkin lymphoma, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667) is a phase 2 interventional study registered as NCT03407144 by Merck Sharp & Dohme LLC, with 340 participants planned, started 2018-04-09 and due to reach its primary completion in 2026-11-06. Interventions recorded: pembrolizumab, doxorubicin, vinblastine, dacarbazine, cyclophosphamide. Conditions listed: Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03407144","url":"https://clinicaltrials.gov/study/NCT03407144"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","early-stage-classical-hodgkin-lymphoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","doxorubicin","vinblastine","dacarbazine","cyclophosphamide","vincristine"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03407144","phase":"2","setting":"An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","sponsor":"Merck Sharp & Dohme LLC","started":"2018-04-09","startedType":"actual","enrolled":340,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03934372","kind":"trial","name":"Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Ponatinib in acute myeloid leukaemia, chronic myeloid leukaemia, acute lymphoblastic leukaemia and non-Hodgkin lymphoma, run by Incyte Biosciences International Sàrl, now recruiting.","summary":"Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors is a phase 1/2 interventional study registered as NCT03934372 by Incyte Biosciences International Sàrl, with 70 participants planned, started 2020-01-29 and due to reach its primary completion in 2028-02-01. Interventions recorded: Ponatinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03934372","url":"https://clinicaltrials.gov/study/NCT03934372"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","cml","all-leukemia","non-hodgkin-lymphoma","all-paediatric-relapsed","aml-paediatric"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ponatinib"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03934372","phase":"1/2","setting":"An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors in Pediatric Participants","sponsor":"Incyte Biosciences International Sàrl","started":"2020-01-29","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03793478","kind":"trial","name":"Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood","aka":[],"tldr":"A phase 1/2 trial of Quizartinib, Fludarabine, Cytarabine and Etoposide in acute myeloid leukaemia, run by Daiichi Sankyo, active and no longer recruiting.","summary":"Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood is a phase 1/2 interventional study registered as NCT03793478 by Daiichi Sankyo, with 65 participants enrolled, started 2018-08-15 and due to reach its primary completion in 2027-05-01. Interventions recorded: Quizartinib, Fludarabine, Cytarabine, Intrathecal (IT) triple chemotherapy prophylaxis and Etoposide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03793478","url":"https://clinicaltrials.gov/study/NCT03793478"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-flt3","aml-paediatric"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["quizartinib","fludarabine","cytarabine","etoposide"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03793478","phase":"1/2","setting":"A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination With Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) With FLT3-ITD Mutations","sponsor":"Daiichi Sankyo","started":"2018-08-15","startedType":"actual","enrolled":65,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06191263","kind":"trial","name":"Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML","aka":["RIVER-81"],"tldr":"A phase 2 trial of Venetoclax in acute myeloid leukaemia, run by Ryvu Therapeutics SA, now recruiting.","summary":"Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML is a phase 2 interventional study registered as NCT06191263 by Ryvu Therapeutics SA, with 98 participants planned, started 2024-01-05 and due to reach its primary completion in 2027-08. Interventions recorded: RVU120 and Venetoclax.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06191263","url":"https://clinicaltrials.gov/study/NCT06191263"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["venetoclax","rvu120"],"companies":["ryvu-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06191263","phase":"2","setting":"A Multicenter, Open-Label, Dose-Finding Clinical Trial to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Efficacy of RVU120 in Combination With Venetoclax in Participants With Acute Myeloid Leukemia Who Failed Prior Therapy With Ventoclax and a Hypomethylating Agent","sponsor":"Ryvu Therapeutics SA","started":"2024-01-05","startedType":"actual","enrolled":98,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07102901","kind":"trial","name":"Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma","aka":[],"tldr":"A phase 2 trial of Trastuzumab rezetecan and Retlirafusp alfa in gastric & gastro-oesophageal junction cancer, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma is a phase 2 interventional study registered as NCT07102901 by Jiangsu HengRui Medicine Co., Ltd., with 351 participants planned, started 2025-09-05 and due to reach its primary completion in 2027-12. Interventions recorded: SHR2554 Tablets, SHR-A1811 Injection, SHR-A1904 Injection and SHR-1701 Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07102901","url":"https://clinicaltrials.gov/study/NCT07102901"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":[],"targets":[],"drugs":["trastuzumab-rezetecan","retlirafusp-alfa"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07102901","phase":"2","setting":"A Multicenter, Open-Label Phase II Clinical Study Evaluating the Safety, Tolerability and Efficacy of SHR2554 Tablets in Combination With Other Antitumor Therapies in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastro-oesophageal Junction Adenocarcinoma","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2025-09-05","startedType":"actual","enrolled":351,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04959903","kind":"trial","name":"Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT","aka":[],"tldr":"A phase 1/2 trial of Allogeneic T cell progenitors, cultured ex-vivo in advanced solid tumours, run by Smart Immune SAS, now recruiting.","summary":"Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT is a phase 1/2 interventional study registered as NCT04959903 by Smart Immune SAS, with 36 participants planned, started 2022-03-31 and due to reach its primary completion in 2025-08. Interventions recorded: Allogeneic T cell progenitors, cultured ex-vivo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04959903","url":"https://clinicaltrials.gov/study/NCT04959903"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04959903","phase":"1/2","setting":"A Phase I/II Study Evaluating the Safety and the Efficacy of SMART101 Injection to Accelerate Immune Reconstitution After T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric and Adult Patients With Hematological Malignancies","sponsor":"Smart Immune SAS","started":"2022-03-31","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05860465","kind":"trial","name":"Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer","aka":[],"tldr":"A phase 2/3 trial testing SPH4336 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer is a phase 2/3 interventional study registered as NCT05860465, led by Shanghai Pharmaceuticals, and recruiting on the registry. Official title: A Phase II/III Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4/6 Inhibitor Combined With Endocrine Therapy. Planned enrolment is 254 participants (estimated). The study started in 2023-09-08 and primary completion is expected in 2026-12-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05860465","url":"https://clinicaltrials.gov/study/NCT05860465"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":[],"targets":[],"drugs":["sph4336"],"companies":["shanghai-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05860465","phase":"2/3","setting":"A Phase II/III Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4/6 Inhibitor Combined With Endocrine Therapy","sponsor":"Shanghai Pharmaceuticals","started":"2023-09-08","startedType":"actual","enrolled":254,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07463599","kind":"trial","name":"Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by HonorHealth Research Institute, now recruiting.","summary":"Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma is a phase 1/2, interventional study registered as NCT07463599 by HonorHealth Research Institute, with a registry enrolment figure of 126 participants, started 2026-02-17 and due to reach its primary completion in 2029-01. Interventions recorded: Tegavivint. Conditions listed: Metastatic Colorectal Carcinoma (mCRC); Colorectal Cancer (CRC); Adenomatous Polyposis Coli (APC) Gene Mutation; Catenin Beta-1 (CTNNB1) Gene Mutation. Primary outcome: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]; Maximum Tolerated Dose (MTD)/Administered Dose. Colorectal eligibility wording from the registry: \"Histologically and/or cytologically documented metastatic colorectal adenocarcinoma (all other histological types are excluded)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07463599","url":"https://clinicaltrials.gov/study/NCT07463599"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07463599","phase":"1/2","setting":"A Phase 1/2, Dose Escalation and Expansion Trial to Evaluate the Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma","sponsor":"HonorHealth Research Institute","started":"2026-02-17","startedType":"actual","enrolled":126,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06016920","kind":"trial","name":"Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in head and neck squamous cell carcinoma, run by Nykode Therapeutics ASA, now recruiting.","summary":"Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma is a phase 1/2 interventional study registered as NCT06016920 by Nykode Therapeutics ASA, with 110 participants planned, started 2023-12-19 and due to reach its primary completion in 2029-01. Interventions recorded: VB10.16 and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06016920","url":"https://clinicaltrials.gov/study/NCT06016920"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06016920","phase":"1/2","setting":"A Phase 1/2, Open-label Trial to Evaluate Safety, Immunogenicity, and Anti-tumor Activity of VB10.16 in Combination With Pembrolizumab in Patients With Unresectable Recurrent or Metastatic HPV16-positive Head and Neck Squamous Cell Carcinoma","sponsor":"Nykode Therapeutics ASA","started":"2023-12-19","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02144077","kind":"trial","name":"Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy","aka":[],"tldr":"A phase 3 trial of Aminolevulinic acid and Methyl aminolevulinate in Basal cell carcinoma, run by Biofrontera Bioscience GmbH, completed.","summary":"Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy is a phase 3 interventional study registered as NCT02144077 by Biofrontera Bioscience GmbH, with 281 participants recorded, started 2014-01-28 and reaching its primary completion in 2015-11-17. Interventions recorded: BF-200 ALA, methyl-aminolevulinate. Conditions recorded: Basal Cell Carcinoma (BCC).\n\nLinked to the drug Methyl aminolevulinate because the registry names it among its interventions and Basal cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02144077","url":"https://clinicaltrials.gov/study/NCT02144077"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["basal-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["aminolevulinic-acid","methyl-aminolevulinate"],"companies":["biofrontera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02144077","phase":"3","setting":"A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) in Comparison to Metvix® in the Treatment of Non-aggressive Basal Cell Carcinoma (BCC) With Photodynamic Therapy (PDT)","sponsor":"Biofrontera Bioscience GmbH","started":"2014-01-28","startedType":"actual","yearReported":2019,"enrolled":281,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT","primary":true,"unit":"%","arms":[{"name":"BF-200 ALA","n":121,"value":93.4,"note":"95% CI 87.0 to 96.9; Figures from the ClinicalTrials.gov results section (first posted 2019-03-11), not from a publication"},{"name":"Methyl-aminolevulinate","n":110,"value":91.8,"note":"95% CI 84.6 to 96.0"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT02144077?tab=results"}]},{"id":"nct02704858","kind":"trial","name":"Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma","aka":[],"tldr":"A phase 1/2 trial of Perillyl alcohol in glioma & glioblastoma, run by Neonc Technologies, Inc., active and no longer recruiting.","summary":"Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma is a phase 1/2 interventional study registered as NCT02704858 by Neonc Technologies, Inc., with 49 participants enrolled, started 2017-08-01 and due to reach its primary completion in 2026-11-30. Interventions recorded: Perillyl alcohol.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02704858","url":"https://clinicaltrials.gov/study/NCT02704858"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma","idh-mutant-astrocytoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["neonc-technologies"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02704858","phase":"1/2","setting":"An Open-Label, Phase 1/2A Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent or Progressive Grade III or Grade IV Gliomas With IDH1 Mutation","sponsor":"Neonc Technologies, Inc.","started":"2017-08-01","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05565807","kind":"trial","name":"Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"A phase 1/2 trial of STI-6129 in multiple myeloma, run by Zhejiang ACEA Pharmaceutical Co. Ltd., now recruiting.","summary":"Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT05565807 by Zhejiang ACEA Pharmaceutical Co. Ltd., with 84 participants planned, started 2023-02-09 and due to reach its primary completion in 2026-12-31. Interventions recorded: STI-6129. Conditions listed: Relapsed or Refractory Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05565807","url":"https://clinicaltrials.gov/study/NCT05565807"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["sti-6129"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05565807","phase":"1/2","setting":"A Phase Ib/IIa, Open-Label, Dose-Escalation and Extension Study to Evaluate the Safety and Efficacy of An Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Multiple Myeloma","sponsor":"Zhejiang ACEA Pharmaceutical Co. Ltd.","started":"2023-02-09","startedType":"actual","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00377429","kind":"trial","name":"Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy","aka":[],"tldr":"A phase 2 trial of Catumaxomab in Ovarian cancer, run by Neovii Biotech, completed.","summary":"Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy is a phase 2 interventional study registered as NCT00377429 by Neovii Biotech, with 47 participants recorded, started 2006-09 and reaching its primary completion in 2008-02. Interventions recorded: catumaxomab. Conditions recorded: Ovarian Cancer.\n\nLinked to the drug Catumaxomab because the registry names it among its interventions and Ovarian cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00377429","url":"https://clinicaltrials.gov/study/NCT00377429"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["catumaxomab"],"companies":["neovii"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00377429","phase":"2","setting":"An Open-Label, Single-Arm, Phase II Safety and Tolerability Study of Catumaxomab (Anti-EpCAM x Anti-CD3) in Women With Advanced Epithelial Ovarian Cancer After a Complete Response to Chemotherapy","sponsor":"Neovii Biotech","started":"2006-09","yearReported":2012,"enrolled":47,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days","primary":true,"unit":"participants","arms":[{"name":"Catumaxomab","n":47,"value":29,"note":"Figures from the ClinicalTrials.gov results section (first posted 2012-07-11), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00377429?tab=results"},{"endpoint":"Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)","unit":"weeks","arms":[{"name":"Catumaxomab","n":43,"value":86.1,"note":"range 21.3 to 141.0; Figures from the ClinicalTrials.gov results section (first posted 2012-07-11), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00377429?tab=results"}]},{"id":"nct04521413","kind":"trial","name":"Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by Treadwell Therapeutics, Inc, active and no longer recruiting.","summary":"Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies is a phase 1/2 interventional study registered as NCT04521413 by Treadwell Therapeutics, Inc, with 170 participants enrolled, started 2020-08-31 and due to reach its primary completion in 2025-11. Interventions recorded: CFI-402411 and Pembrolizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04521413","url":"https://clinicaltrials.gov/study/NCT04521413"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["treadwell-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04521413","phase":"1/2","setting":"A First-In-Human, Phase 1/2 Study Of CFI-402411, a Hematopoietic Progenitor Kinase-1 (HPK1) Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Malignancies","sponsor":"Treadwell Therapeutics, Inc","started":"2020-08-31","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04623541","kind":"trial","name":"Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome","aka":["EPCORE CLL-1"],"tldr":"A phase 1/2 trial of Epcoritamab, Prednisone, Cyclophosphamide, Doxorubicin, Rituximab and Vincristine in chronic lymphocytic leukaemia, run by Genmab, active and no longer recruiting.","summary":"Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome is a phase 1/2 interventional study registered as NCT04623541 by Genmab, with 194 participants enrolled, started 2020-11-25 and due to reach its primary completion in 2027-12. Interventions recorded: Epcoritamab, rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone, Venetoclax, Lenalidomide and Pirtobrutinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04623541","url":"https://clinicaltrials.gov/study/NCT04623541"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","richter-transformation-cll","cll-relapsed"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["epcoritamab","prednisone","cyclophosphamide","doxorubicin","rituximab","vincristine"],"companies":["genmab","abbvie","eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04623541","phase":"1/2","setting":"A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome","sponsor":"Genmab","started":"2020-11-25","startedType":"actual","enrolled":194,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05117242","kind":"trial","name":"Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer","aka":[],"tldr":"A phase 2 trial of Acasunlimab, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Genmab, stopped early.","summary":"Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer is a phase 2 interventional study registered as NCT05117242 by Genmab, with 125 participants enrolled, started 2021-10-27 and reached its primary completion in 2024-12-02. Interventions recorded: Acasunlimab, Pembrolizumab. Conditions listed: Non Small Cell Lung Cancer Metastatic. No results are recorded here; the registry entry is the source.","status":"withdrawn","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05117242","url":"https://clinicaltrials.gov/study/NCT05117242"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["acasunlimab","pembrolizumab"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registry status on 22 September 2026: Terminated (registry record last updated 21 September 2026; primary completion reached 2 December 2024). Why stopped, in the sponsor's words: Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision was not related to safety concerns."],"nct":"NCT05117242","phase":"2","setting":"A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination Pembrolizumab Therapy in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor","sponsor":"Genmab","started":"2021-10-27","startedType":"actual","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05951179","kind":"trial","name":"Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer","aka":[],"tldr":"A phase 2 trial of TARA-002 in bladder & urothelial cancer, run by Protara Therapeutics, now recruiting.","summary":"Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer is a phase 2 interventional study registered as NCT05951179 by Protara Therapeutics, with 131 participants planned, started 2023-09-15 and due to reach its primary completion in 2031-10. Interventions recorded: TARA-002.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05951179","url":"https://clinicaltrials.gov/study/NCT05951179"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tara-002"],"companies":["protara-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05951179","phase":"2","setting":"A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer","sponsor":"Protara Therapeutics","started":"2023-09-15","startedType":"actual","enrolled":131,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04938817","kind":"trial","name":"Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)","aka":["KEYNOTE-B98"],"tldr":"A phase 1/2 trial of Pembrolizumab, Lenvatinib and Favezelimab in small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98) is a phase 1/2 interventional study registered as NCT04938817 by Merck Sharp & Dohme LLC, with 110 participants enrolled, started 2021-08-19 and due to reach its primary completion in 2029-12-10. Interventions recorded: coformulation pembrolizumab/quavonlimab, lenvatinib, MK-4830, coformulation favezelimab/pembrolizumab and R-DXd.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04938817","url":"https://clinicaltrials.gov/study/NCT04938817"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","lenvatinib","favezelimab"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04938817","phase":"1/2","setting":"A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Investigational Agents as Monotherapy or in Combination With Pembrolizumab for the Treatment of Participants With PD-1/L1-refractory Extensive-Stage Small Cell Lung Cancer in Need of Second-Line Therapy (KEYNOTE-B98)","sponsor":"Merck Sharp & Dohme LLC","started":"2021-08-19","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06334432","kind":"trial","name":"Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of NUV-1511 in prostate cancer, pancreatic ductal adenocarcinoma and ovarian cancer, run by Nuvation Bio Inc., active and no longer recruiting.","summary":"Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06334432 by Nuvation Bio Inc., with 466 participants enrolled, started 2024-03-14 and due to reach its primary completion in 2027-03. Interventions recorded: NUV-1511.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06334432","url":"https://clinicaltrials.gov/study/NCT06334432"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","pancreatic","ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["nuv-1511"],"companies":["nuvation-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06334432","phase":"1/2","setting":"A Phase 1/2, First-in-Human, Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors","sponsor":"Nuvation Bio Inc.","started":"2024-03-14","startedType":"actual","enrolled":466,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06508931","kind":"trial","name":"Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell Neoplasms","aka":["DALY PED"],"tldr":"A phase 2 trial of Zamtocabtagene autoleucel in advanced solid tumours, run by Miltenyi Biomedicine GmbH, now recruiting.","summary":"Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell Neoplasms is a phase 2 interventional study registered as NCT06508931 by Miltenyi Biomedicine GmbH, with 31 participants planned, started 2025-08-04 and due to reach its primary completion in 2029-12-31. Interventions recorded: zamtocabtagene autoleucel (MB-CART2019.1).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06508931","url":"https://clinicaltrials.gov/study/NCT06508931"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["zamtocabtagene-autoleucel"],"companies":["miltenyi-biomedicine"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06508931","phase":"2","setting":"A Single-arm, Multi-center, Open-label Phase II Study to Determine the Safety and Efficacy of MB-CART2019.1 in Pediatric Subjects With Relapsed/Refractory Mature B-cell Neoplasms Who Have Relapsed After One or More Prior Therapies, Including Subjects With Primary Refractory Disease","sponsor":"Miltenyi Biomedicine GmbH","started":"2025-08-04","startedType":"actual","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04663347","kind":"trial","name":"Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)","aka":["EPCORE NHL-2"],"tldr":"A phase 1/2 trial of Rituximab, Cyclophosphamide, Doxorubicin in diffuse large b-cell lymphoma and follicular lymphoma, run by Genmab, active and no longer recruiting.","summary":"Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) is a phase 1/2 interventional study registered as NCT04663347 by Genmab, with 543 participants enrolled, started 2020-11-03 and due to reach its primary completion in 2027-09-30. Interventions recorded: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, rituximab and lenalidomide, rituximab and bendamustine, rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin, gemcitabine and oxaliplatin. Conditions listed: Diffuse Large B-Cell Lymphoma, Follicular Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04663347","url":"https://clinicaltrials.gov/study/NCT04663347"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl","follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone","lenalidomide"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04663347","phase":"1/2","setting":"A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)","sponsor":"Genmab","started":"2020-11-03","startedType":"actual","enrolled":543,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07575191","kind":"trial","name":"Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of Gemcitabine in pancreatic ductal adenocarcinoma, run by Smartwise Sweden AB, now recruiting.","summary":"Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer is a phase 1/2 interventional study registered as NCT07575191 by Smartwise Sweden AB, with 9 participants planned, started 2026-04-29 and due to reach its primary completion in 2027-12. Interventions recorded: Gemcitabine and Extroducer Infusion Catheter System.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07575191","url":"https://clinicaltrials.gov/study/NCT07575191"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07575191","phase":"1/2","setting":"A Single-center, Prospective, Non-randomized, Open, Pilot Study Evaluating the Safety and Performance of the Extroducer® Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Unresectable Locally Advanced Pancreatic Cancer","sponsor":"Smartwise Sweden AB","started":"2026-04-29","startedType":"actual","enrolled":9,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03436485","kind":"trial","name":"Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer","aka":["CYPIDES"],"tldr":"A phase 1/2 trial of Opevesostat in prostate cancer, run by Orion Corporation, Orion Pharma, active and no longer recruiting.","summary":"Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer is a phase 1/2 interventional study registered as NCT03436485 by Orion Corporation, Orion Pharma, with 204 participants enrolled, started 2018-03-19 and due to reach its primary completion in 2026-10-31. Interventions recorded: ODM-208, Midazolam. Conditions listed: Prostate Cancer Metastatic. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03436485","url":"https://clinicaltrials.gov/study/NCT03436485"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["opevesostat"],"companies":["orion-orion-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03436485-nejm-evid-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03436485","phase":"1/2","setting":"Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer","sponsor":"Orion Corporation, Orion Pharma","started":"2018-03-19","startedType":"actual","enrolled":204,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05222555","kind":"trial","name":"Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients","aka":["MINDway"],"tldr":"A phase 1/2 trial of Tafasitamab, Lenalidomide in diffuse large b-cell lymphoma, run by Incyte Corporation, active and no longer recruiting.","summary":"Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients is a phase 1/2 interventional study registered as NCT05222555 by Incyte Corporation, with 53 participants enrolled, started 2022-07-19 and due to reach its primary completion in 2024-07-17. Interventions recorded: Tafasitamab, Lenalidomide. Conditions listed: Diffuse Large B Cell Lymphoma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05222555","url":"https://clinicaltrials.gov/study/NCT05222555"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["tafasitamab","lenalidomide"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05222555","phase":"1/2","setting":"A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","sponsor":"Incyte Corporation","started":"2022-07-19","startedType":"actual","yearReported":2025,"enrolled":53,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Any Treatment-emergent Adverse Event (TEAE)","primary":true,"unit":"participants","arms":[{"name":"Tafasitamab Dose Level 1 + 25 mg Lenalidomide","n":6,"value":6,"note":"Figures from the ClinicalTrials.gov results section (first posted 2025-07-28), not from a publication"},{"name":"Tafasitamab Dose Level 2 + 25 mg Lenalidomide","n":47,"value":45}],"source":"https://clinicaltrials.gov/study/NCT05222555?tab=results"}]},{"id":"nct07463235","kind":"trial","name":"Safety and Potency of a High Cabergoline Dosage in Microprolactinomas","aka":["SPARAGMOS"],"tldr":"A phase 3 trial of Cabergoline in Pituitary tumours, run by University of Sao Paulo General Hospital, now recruiting.","summary":"Safety and Potency of a High Cabergoline Dosage in Microprolactinomas is a phase 3 interventional study registered as NCT07463235 by University of Sao Paulo General Hospital, with 70 participants planned, started 2026-03-04 and due to reach its primary completion in 2027-08-20. Interventions recorded: Cabergoline, Cabergoline. Conditions recorded: Prolactinoma, Prolactin Excess.\n\nLinked to the drug Cabergoline because the registry names it among its interventions and Pituitary tumours among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07463235","url":"https://clinicaltrials.gov/study/NCT07463235"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pituitary-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["cabergoline"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07463235","phase":"3","setting":"Safety and Potency of a High Cabergoline Dosage in Microprolactinomas","sponsor":"University of Sao Paulo General Hospital","started":"2026-03-04","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05544552","kind":"trial","name":"Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations","aka":["SURF301"],"tldr":"A phase 1/2 trial of TYRA-300 in bladder & urothelial cancer, run by Tyra Biosciences, Inc, active and no longer recruiting.","summary":"Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations is a phase 1/2 interventional study registered as NCT05544552 by Tyra Biosciences, Inc, with 310 participants enrolled, started 2022-11-22 and due to reach its primary completion in 2026-11. Interventions recorded: TYRA-300.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05544552","url":"https://clinicaltrials.gov/study/NCT05544552"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tyra-300"],"companies":["tyra-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05544552","phase":"1/2","setting":"A Multicenter, Open-label Phase 1/2 Study of TYRA300 in Advanced Urothelial Carcinoma and Other Solid Tumors With Activating FGFR3 Gene Alterations (SURF301)","sponsor":"Tyra Biosciences, Inc","started":"2022-11-22","startedType":"actual","enrolled":310,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06750185","kind":"trial","name":"Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of BNT317 DL1 in advanced solid tumours, run by BioNTech SE, now recruiting.","summary":"Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06750185 by BioNTech SE, with 248 participants planned, started 2025-01-13 and due to reach its primary completion in 2031-04. Interventions recorded: BNT317 DL1, BNT317 DL2, BNT317 DL3, BNT317 DL4, BNT317 DL5 and BNT317 DL6.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06750185","url":"https://clinicaltrials.gov/study/NCT06750185"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06750185","phase":"1/2","setting":"A Phase I/II, First-in-human, Open-label Trial of the Safety, Efficacy, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Participants With Advanced Solid Tumors","sponsor":"BioNTech SE","started":"2025-01-13","startedType":"actual","enrolled":248,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06449222","kind":"trial","name":"Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy","aka":[],"tldr":"A phase 2 trial of Carboplatin, Gemcitabine and Eribulin in triple-negative breast cancer, run by BioNTech SE, active and no longer recruiting.","summary":"Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy is a phase 2 interventional study registered as NCT06449222 by BioNTech SE, with 83 participants enrolled, started 2024-08-26 and due to reach its primary completion in 2028-08. Interventions recorded: BNT327 Dose Level 1 (DL1), BNT327 Dose Level 1 (DL2), Nab-placlitaxel, Carboplatin, Gemcitabine and Paclitaxel.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06449222","url":"https://clinicaltrials.gov/study/NCT06449222"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":["carboplatin","gemcitabine","eribulin"],"companies":["biontech","bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06449222","phase":"2","setting":"A Phase II, Multi-site, Randomized, Open-label Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative Breast Cancer","sponsor":"BioNTech SE","started":"2024-08-26","startedType":"actual","enrolled":83,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06841055","kind":"trial","name":"Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Che","aka":[],"tldr":"A phase 2 trial of PM8002, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by BioNTech SE, now recruiting.","summary":"Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment is a phase 2 interventional study registered as NCT06841055 by BioNTech SE, with 60 participants planned, started 2025-03-03 and due to reach its primary completion in 2028-10. Interventions recorded: Pumitamig, Docetaxel. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06841055","url":"https://clinicaltrials.gov/study/NCT06841055"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002","docetaxel"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06841055","phase":"2","setting":"A Phase II, Multisite, Open-label Trial of Pumitamig (BNT327) in Combination With Standard-of-care Chemotherapy in First-line and Second-line Non-small Cell Lung Cancer (NSCLC)","sponsor":"BioNTech SE","started":"2025-03-03","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06578624","kind":"trial","name":"Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SA53-OS (phase 1) in advanced solid tumours, run by Lamassu Bio Inc, now recruiting.","summary":"Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06578624 by Lamassu Bio Inc, with 70 participants planned, started 2025-03-10 and due to reach its primary completion in 2026-12. Interventions recorded: SA53-OS (phase 1) and SA53-OS (phase 2).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06578624","url":"https://clinicaltrials.gov/study/NCT06578624"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["mdm2"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06578624","phase":"1/2","setting":"A Phase 1/2a, Open-Label Study of Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SA53-OS, an MDM2 Inhibitor, in Patients With Locally Advanced or Metastatic p53 Wild-Type Solid Tumors","sponsor":"Lamassu Bio Inc","started":"2025-03-10","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05744427","kind":"trial","name":"Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of JSKN003 in advanced solid tumours, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd, active and no longer recruiting.","summary":"Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05744427 by Jiangsu Alphamab Biopharmaceuticals Co., Ltd, with 725 participants enrolled, started 2023-03-15 and due to reach its primary completion in 2026-07-30. Interventions recorded: JSKN003.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05744427","url":"https://clinicaltrials.gov/study/NCT05744427"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["jskn003"],"companies":["alphamab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05744427","phase":"1/2","setting":"Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of JSKN003 in Chinese Subjects With Advanced Solid Tumors","sponsor":"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","started":"2023-03-15","startedType":"actual","enrolled":725,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06810544","kind":"trial","name":"Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss","aka":[],"tldr":"A phase 1/2 trial of TNG456, Abemaciclib in non-small-cell lung cancer and small-cell lung cancer, run by Tango Therapeutics, Inc., now recruiting.","summary":"Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss is a phase 1/2 interventional study registered as NCT06810544 by Tango Therapeutics, Inc., with 191 participants planned, started 2025-03-24 and due to reach its primary completion in 2027-03-31. Interventions recorded: TNG456, abemaciclib. Conditions listed: Non Small Cell Lung Cancer, Glioma Glioblastoma Multiforme, Glioma, Malignant, Solid Tumor. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06810544","url":"https://clinicaltrials.gov/study/NCT06810544"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","glioblastoma"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["tng456","abemaciclib"],"companies":["tango-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06810544","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG456 Monotherapy and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss","sponsor":"Tango Therapeutics, Inc.","started":"2025-03-24","startedType":"actual","enrolled":191,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05732831","kind":"trial","name":"Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of TNG462 and Pembrolizumab in advanced solid tumours, run by Tango Therapeutics, Inc., now recruiting.","summary":"Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors is a phase 1/2 interventional study registered as NCT05732831 by Tango Therapeutics, Inc., with 225 participants planned, started 2023-05-26 and due to reach its primary completion in 2027-06. Interventions recorded: TNG462 and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05732831","url":"https://clinicaltrials.gov/study/NCT05732831"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tng462","pembrolizumab"],"companies":["tango-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05732831","phase":"1/2","setting":"A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 as a Single Agent and in Combination in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors","sponsor":"Tango Therapeutics, Inc.","started":"2023-05-26","startedType":"actual","enrolled":225,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06028074","kind":"trial","name":"Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies","aka":[],"tldr":"A phase 1/2 trial of GIM122 in advanced solid tumours, run by Georgiamune Inc, now recruiting.","summary":"Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies is a phase 1/2 interventional study registered as NCT06028074 by Georgiamune Inc, with 111 participants planned, started 2023-12-12 and due to reach its primary completion in 2026-09. Interventions recorded: GIM122.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06028074","url":"https://clinicaltrials.gov/study/NCT06028074"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["georgiamune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06028074","phase":"1/2","setting":"A First-in-Human, Open-Label, Phase 1/2 Dose-Escalation With Enrichment and Dose-Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GIM-122 as a Single Agent in Adult Subjects With Advanced Solid Malignancies","sponsor":"Georgiamune Inc","started":"2023-12-12","startedType":"actual","enrolled":111,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06425926","kind":"trial","name":"Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of GIM-531 in melanoma, run by Georgiamune Inc, now recruiting.","summary":"Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06425926 by Georgiamune Inc, with 117 participants planned, started 2024-05-09 and due to reach its primary completion in 2026-12. Interventions recorded: GIM-531 and Anti-PD-1 monoclonal antibody.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06425926","url":"https://clinicaltrials.gov/study/NCT06425926"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["georgiamune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06425926","phase":"1/2","setting":"A Phase 1/2, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of GIM-531 as a Single Agent and in Combination With Anti-PD-1 in Advanced Solid Tumors","sponsor":"Georgiamune Inc","started":"2024-05-09","startedType":"actual","enrolled":117,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03003065","kind":"trial","name":"Safety and Tumoricidal Effect of Low Dose Foscan PDT in Patients With Inoperable Bile Duct Cancers","aka":[],"tldr":"A phase 2 trial of Temoporfin in Extrahepatic cholangiocarcinoma, run by Chinese University of Hong Kong, completed.","summary":"Safety and Tumoricidal Effect of Low Dose Foscan PDT in Patients With Inoperable Bile Duct Cancers is a phase 2 interventional study registered as NCT03003065 by Chinese University of Hong Kong, with 10 participants recorded, started 2014-03-28 and reaching its primary completion in 2023-04-12. Interventions recorded: Temoporfin. Conditions recorded: Cholangiocarcinoma, Tumor, Klatskin Tumor.\n\nLinked to the drug Temoporfin because the registry names it among its interventions and Extrahepatic cholangiocarcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03003065","url":"https://clinicaltrials.gov/study/NCT03003065"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["extrahepatic-cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["temoporfin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03003065","phase":"2","setting":"Safety and Tumoricidal Effect of Low Dose Temoporfin Photodynamic Therapy in Patients With Inoperable Bile Duct Cancers (Foscan® Study)","sponsor":"Chinese University of Hong Kong","started":"2014-03-28","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02505750","kind":"trial","name":"Safety of a Boost (CXB or EBRT) in Combination With Neoadjuvant Chemoradiotherapy for Early Rectal Adenocarcinoma","aka":["OPERA"],"tldr":"A phase 3 trial of capecitabine in colorectal cancer, run by Centre Antoine Lacassagne, active but no longer recruiting.","summary":"Safety of a Boost (CXB or EBRT) in Combination With Neoadjuvant Chemoradiotherapy for Early Rectal Adenocarcinoma is a phase 3, randomised interventional study registered as NCT02505750 by Centre Antoine Lacassagne, with a registry enrolment figure of 148 participants, started 2015-06-24 and due to reach its primary completion in 2023-06-07. Interventions recorded: 3D conformal EBRT; Contact X-ray brachytherapy 50 kV; Capecitabine. Conditions listed: Rectal Neoplasms. Primary outcome: Rate of rectum preservation either with local excision or watch and wait strategy after neoadjuvant treatment without non salvageable locally progressive disease at 3 years post treatment, or permanent stoma.. Colorectal eligibility wording from the registry: \"Adenocarcinoma of the rectum classified clinically T2, T3a, T3b (penetration in the mesorectal fat between 1 to 5 mm) by TNM classification (Tumour Node Metastase), \\< 5 cm largest diameter, \\< half rectal circumference (by MRI staging), N0-N1 (any node \\< 8 mm diameter on MRI), M0\". Sites: France, Switzerland, United Kingdom. United Kingdom sites listed: 5. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02505750","url":"https://clinicaltrials.gov/study/NCT02505750"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry): Royal Surrey County Hospital (Guildford); Spire Hull and East Riding Hospital (Hull); Clatterbridge Cancer Centre NHS Foundation Trust (Liverpool); Christie Hospital (Manchester); University Hospital (Nottingham)."],"nct":"NCT02505750","phase":"3","setting":"European Phase III Study Comparing a Radiation Dose Escalation Using 2 Different Approaches : External Beam Radiation Therapy Versus Endocavitary Radiation Therapy With Contact X-ray Brachytherapy 50 kiloVolts (kV) for Patients With Rectal Adenocarcinoma","sponsor":"Centre Antoine Lacassagne","started":"2015-06-24","startedType":"actual","enrolled":148,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06274879","kind":"trial","name":"Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of durvalumab and cisplatin in gallbladder cancer and other biliary tract cancers, run by Insel Gruppe AG, University Hospital Bern, now recruiting.","summary":"Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer is a phase 2, randomised interventional study registered as NCT06274879 by Insel Gruppe AG, University Hospital Bern, with a registry enrolment figure of 36 participants, started 2026-05-20 and due to reach its primary completion in 2029-12-30. Interventions recorded: Gemcitabin, Cisplatin and Durvalumab, Biliary Radiofrequency Ablation, Endoscopic Retrograde Cholangio-Pancreatography with stenting. Conditions listed: Bile Duct Cancer. Sites: Switzerland. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06274879","url":"https://clinicaltrials.gov/study/NCT06274879"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["durvalumab","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06274879","phase":"2","setting":"Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer (EBTC) Undergoing Systemic Anti-tumor Therapy: a Phase II, Multi-center, Randomized, and Controlled Study (Ablatio-bilica)","sponsor":"Insel Gruppe AG, University Hospital Bern","started":"2026-05-20","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06638502","kind":"trial","name":"Safety of HRX215 in Patients After Minor and Major Liver Resection","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by HepaRegeniX GmbH, now recruiting.","summary":"Safety of HRX215 in Patients After Minor and Major Liver Resection is a phase 1/2, randomised interventional study registered as NCT06638502 by HepaRegeniX GmbH, with a registry enrolment figure of 80 participants, started 2025-05-06 and due to reach its primary completion in 2027-07-31. Interventions recorded: HRX215 capsules; Placebo capsules. Conditions listed: Liver Resection; Colorectal Carcinoma Liver Metastases. Primary outcome: Adverse Events (AEs) observed; HRX215 plasma levels. Colorectal eligibility wording from the registry: \"* Participants with liver metastases originating from colon carcinoma planned for R0-intended hepatectomy for colorectal liver metastases\". Sites: France, Germany, Israel, Spain, United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06638502","url":"https://clinicaltrials.gov/study/NCT06638502"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06638502","phase":"1/2","setting":"Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of HRX215 in Participants After Major Hepatectomy, Preceded by Two Open Pilot Parts in Participants After Minor and After Major Hepatectomy Due to Colon Carcinoma Metastases","sponsor":"HepaRegeniX GmbH","started":"2025-05-06","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06245356","kind":"trial","name":"Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer","aka":["TRIFLUOX-DP"],"tldr":"A phase 2 trial of trifluridine/tipiracil, fOLFOX (5-FU, leucovorin, oxaliplatin), panitumumab, bevacizumab (glioblastoma use) and other drugs in colorectal cancer, run by UNICANCER, now recruiting.","summary":"Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer is a phase 2, interventional study registered as NCT06245356 by UNICANCER, with a registry enrolment figure of 73 participants, started 2025-03-21 and due to reach its primary completion in 2026-10-22. Interventions recorded: Lonsurf; Oxaliplatin; Panitumumab; Bevacizumab; Trastuzumab; Nivolumab. Conditions listed: Metastatic Colorectal Cancer; Metastatic Gastroesophageal Adenocarcinoma; DPD Deficiency. Primary outcome: Treatment specific safety. Colorectal eligibility wording from the registry: \"Histological or cytological documentation of adenocarcinoma of the colon or rectum or gastroesophageal cancer (lower oesophagus, gastroesophageal junction and gastric)\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06245356","url":"https://clinicaltrials.gov/study/NCT06245356"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["trifluridine-tipiracil","folfox","panitumumab","bevacizumab-glioma","trastuzumab","nivolumab"],"companies":["servier","unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06245356","phase":"2","setting":"TRIFLUOX-DP: Safety of Trifluridine/Tipiracil as Replacement of Fluoropyrimidines (5-fluorouracil and Capecitabine) Based Chemotherapy as First Line Metastatic Colorectal or Gastroesophageal Cancer Regimens in Patients With Dihydropyrimidine Dehydrogenase Deficiency: a Phase II Trial","sponsor":"UNICANCER","started":"2025-03-21","startedType":"actual","enrolled":73,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01744223","kind":"trial","name":"Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant","aka":[],"tldr":"A phase 1/2 trial of BPX-501 dose 1 in acute lymphoblastic leukaemia, non-Hodgkin lymphoma and myelodysplastic syndromes / neoplasms, run by Bellicum Pharmaceuticals, active and no longer recruiting.","summary":"Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant is a phase 1/2 interventional study registered as NCT01744223 by Bellicum Pharmaceuticals, with 36 participants enrolled, started 2013-03 and due to reach its primary completion in 2019-10-09. Interventions recorded: BPX-501 dose 1, Rimiducid, BPX-501 dose 2, BPX-501 dose 3, BPX-501 dose 4 and SCT.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01744223","url":"https://clinicaltrials.gov/study/NCT01744223"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","non-hodgkin-lymphoma","mds"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bellicum"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01744223","phase":"1/2","setting":"A Phase 1/2 Dose Escalation Study Evaluating Safety and Feasibility of BPX-501 T Cells After Partially Mismatched, Related, T Cell-Depleted HSCT (Hematopoietic Stem Cell Transplant)","sponsor":"Bellicum Pharmaceuticals","started":"2013-03","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06712316","kind":"trial","name":"Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer","aka":[],"tldr":"A phase 2/3 trial of PM8002, Pembrolizumab, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by BioNTech SE, now recruiting.","summary":"Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer is a phase 2/3 interventional study registered as NCT06712316 by BioNTech SE, with 1580 participants planned, started 2025-01-07 and due to reach its primary completion in 2029-01. Interventions recorded: Pumitamig, Pembrolizumab, Carboplatin, Pemetrexed, Paclitaxel. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06712316","url":"https://clinicaltrials.gov/study/NCT06712316"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002","pembrolizumab","carboplatin","pemetrexed","paclitaxel"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06712316","phase":"2/3","setting":"A Phase II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer","sponsor":"BioNTech SE","started":"2025-01-07","startedType":"actual","enrolled":1580,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06087653","kind":"trial","name":"Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)","aka":["STAR-LLD"],"tldr":"A phase 1/2 trial of Lenalidomide, Dexamethasone in multiple myeloma, run by Starton Therapeutics, Inc, now recruiting.","summary":"Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM) is a phase 1/2 interventional study registered as NCT06087653 by Starton Therapeutics, Inc, with 24 participants planned, started 2023-10-02 and due to reach its primary completion in 2027-05-31. Interventions recorded: Lenalidomide, Lenalidomide 25 MG Oral Capsule. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06087653","url":"https://clinicaltrials.gov/study/NCT06087653"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["protac-degrader"],"targets":[],"drugs":["lenalidomide","dexamethasone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06087653","phase":"1/2","setting":"A Protocol to Assess the Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Administration of Low-dose Lenalidomide (STAR-LLD) for the Treatment of Multiple Myeloma (MM)","sponsor":"Starton Therapeutics, Inc","started":"2023-10-02","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03970746","kind":"trial","name":"Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by PDC*line Pharma SAS, active and no longer recruiting.","summary":"Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC is a phase 1/2 interventional study registered as NCT03970746 by PDC*line Pharma SAS, with 73 participants enrolled, started 2019-09-10 and due to reach its primary completion in 2024-07-18. Interventions recorded: PDC*lung01, Keytruda Injectable Product, Alimta Injectable Product. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03970746","url":"https://clinicaltrials.gov/study/NCT03970746"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03970746","phase":"1/2","setting":"An Open-label, Dose-escalation, Phase I/II Study to Assess the Safety, the Tolerability, the Immunogenicity and the Preliminary Clinical Activity of the Therapeutic Cancer Vaccine, PDC*lung01, Associated or Not With Anti-PD-1 Treatment in Patients With Non-small-cell Lung Cancer (NSCLC)","sponsor":"PDC*line Pharma SAS","started":"2019-09-10","startedType":"actual","enrolled":73,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04999969","kind":"trial","name":"Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours","aka":[],"tldr":"A phase 2 trial of Durvalumab and Gemcitabine in advanced solid tumours, run by AstraZeneca, active and no longer recruiting.","summary":"Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours is a phase 2 interventional study registered as NCT04999969 by AstraZeneca, with 126 participants enrolled, started 2021-12-10 and due to reach its primary completion in 2024-10-07. Interventions recorded: AZD0171, Durvalumab, Gemcitabine and Nab-paclitaxel. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04999969","url":"https://clinicaltrials.gov/study/NCT04999969"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","gemcitabine"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04999969","phase":"2","setting":"A Phase II Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumours","sponsor":"AstraZeneca","started":"2021-12-10","startedType":"actual","yearReported":2025,"enrolled":126,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival at 12 Months (OS-12)","primary":true,"unit":"%","arms":[{"name":"AZD0171 + Durvalumab + Chemotherapy","n":126,"value":53.8,"note":"80% CI 47.79 to 59.50; Figures from the ClinicalTrials.gov results section (first posted 2025-11-26), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04999969?tab=results"},{"endpoint":"Median Progression Free Survival (PFS)","unit":"months","arms":[{"name":"AZD0171 + Durvalumab + Chemotherapy","n":126,"value":7.33,"note":"80% CI 6.801 to 7.918; Figures from the ClinicalTrials.gov results section (first posted 2025-11-26), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04999969?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"AZD0171 + Durvalumab + Chemotherapy","n":126,"value":34.9,"note":"80% CI 29.30 to 40.91; Figures from the ClinicalTrials.gov results section (first posted 2025-11-26), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04999969?tab=results"}]},{"id":"nct06635785","kind":"trial","name":"Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors","aka":["BiPAVE-001"],"tldr":"A phase 1/2 trial of AI-081 in advanced solid tumours, run by OncoC4, Inc., now recruiting.","summary":"Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06635785 by OncoC4, Inc., with 387 participants planned, started 2025-03-26 and due to reach its primary completion in 2027-06-30. Interventions recorded: AI-081.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06635785","url":"https://clinicaltrials.gov/study/NCT06635785"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ai-081"],"companies":["oncoc4"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06635785","phase":"1/2","setting":"Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors","sponsor":"OncoC4, Inc.","started":"2025-03-26","startedType":"actual","enrolled":387,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04140526","kind":"trial","name":"Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC","aka":["PRESERVE-001"],"tldr":"A phase 1/2 trial of Gotistobart, Pembrolizumab, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by OncoC4, Inc., active and no longer recruiting.","summary":"Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC is a phase 1/2 interventional study registered as NCT04140526 by OncoC4, Inc., with 733 participants planned, started 2020-09-16 and due to reach its primary completion in 2026-12-31. Interventions recorded: ONC-392, Pembrolizumab, Docetaxel. Conditions listed: Non Small Cell Lung Cancer, Advanced Solid Tumor, Metastatic Melanoma, Metastatic Head and Neck Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04140526","url":"https://clinicaltrials.gov/study/NCT04140526"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","melanoma","rcc","colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["gotistobart","pembrolizumab","docetaxel"],"companies":["oncoc4"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04140526","phase":"1/2","setting":"Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001)","sponsor":"OncoC4, Inc.","started":"2020-09-16","startedType":"actual","enrolled":733,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06014658","kind":"trial","name":"Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Antibody-Drug Conjugate in advanced solid tumours, run by MBrace Therapeutics, now recruiting.","summary":"Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors is a phase 1/2 interventional study registered as NCT06014658 by MBrace Therapeutics, with 130 participants planned, started 2023-11-07 and due to reach its primary completion in 2026-07. Interventions recorded: Antibody-Drug Conjugate.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06014658","url":"https://clinicaltrials.gov/study/NCT06014658"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["mbrace-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06014658","phase":"1/2","setting":"A Multicenter, Open-label, Phase 1/1b / Phase 2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-101, an Anti-EphA5 Monomethyl Auristatin E (MMAE) Antibody Drug Conjugate, in Advanced Refractory Solid Tumors","sponsor":"MBrace Therapeutics","started":"2023-11-07","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06449209","kind":"trial","name":"Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy","aka":[],"tldr":"A phase 2 trial of Etoposide, Carboplatin, Paclitaxel / nab-paclitaxel in small-cell lung cancer, run by BioNTech SE, active and no longer recruiting.","summary":"Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy is a phase 2 interventional study registered as NCT06449209 by BioNTech SE, with 110 participants planned, started 2024-08-05 and due to reach its primary completion in 2027-06. Interventions recorded: BNT327 Dose Level 1 (DL1), BNT327 Dose Level 2 (DL2), Etoposide, Carboplatin, Paclitaxel. Conditions listed: Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06449209","url":"https://clinicaltrials.gov/study/NCT06449209"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["etoposide","carboplatin","paclitaxel","topotecan"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06449209","phase":"2","setting":"A Phase II, Multi-site, Open-label, Parallel Group Trial of BNT327 in Combination With Chemotherapy for Participants With Untreated Extensive-stage Small-cell Lung Cancer and Participants With Previously Treated Small-cell Lung Cancer","sponsor":"BioNTech SE","started":"2024-08-05","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05338931","kind":"trial","name":"Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma","aka":[],"tldr":"A phase 1/2 trial of AT101 in hodgkin lymphoma and non-hodgkin lymphoma, run by AbClon, now recruiting.","summary":"Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma is a phase 1/2 interventional study registered as NCT05338931 by AbClon, with 82 participants planned, started 2022-03-15 and due to reach its primary completion in 2030-03-15. Interventions recorded: AT101(Anti-CD19 Chimeric Antigen Receptor T cell). Conditions listed: B-cell Non Hodgkin Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05338931","url":"https://clinicaltrials.gov/study/NCT05338931"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["at101"],"companies":["abclon"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05338931","phase":"1/2","setting":"An Open-label, Single-arm, Multi-center, Phase I/II Study to Evaluate the Safety, Tolerability, and Efficacy of AT101 (Anti-CD19 Chimeric Antigen Receptor T Cell) in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma","sponsor":"AbClon","started":"2022-03-15","startedType":"actual","enrolled":82,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06732531","kind":"trial","name":"Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer","aka":[],"tldr":"A phase 1/2 trial of BH011 in bladder & urothelial cancer, run by Zhuhai Beihai Biotech Co., Ltd, now recruiting.","summary":"Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer is a phase 1/2 interventional study registered as NCT06732531 by Zhuhai Beihai Biotech Co., Ltd, with 48 participants planned, started 2022-08-03 and due to reach its primary completion in 2025-12. Interventions recorded: BH011.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06732531","url":"https://clinicaltrials.gov/study/NCT06732531"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06732531","phase":"1/2","setting":"A Phase I/II, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of BH011 in Subjects With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer After Bacillus Calmette-Guérin","sponsor":"Zhuhai Beihai Biotech Co., Ltd","started":"2022-08-03","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05877430","kind":"trial","name":"Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in melanoma and metastatic cancer, run by CJ Bioscience, Inc., now recruiting.","summary":"Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer is a phase 1/2 interventional study registered as NCT05877430 by CJ Bioscience, Inc., with 160 participants planned, started 2023-09-11 and due to reach its primary completion in 2026-07. Interventions recorded: CJRB-101, Pembrolizumab injection. Conditions listed: NSCLC, HNSCC, Melanoma, Metastatic Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05877430","url":"https://clinicaltrials.gov/study/NCT05877430"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05877430-j-immunother-cancer-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05877430","phase":"1/2","setting":"Phase 1/2 Open Label, Safety and Preliminary Efficacy Study of a Live Biotherapeutic Product (CJRB-101) in Combination With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer","sponsor":"CJ Bioscience, Inc.","started":"2023-09-11","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"safir-abc10","kind":"trial","name":"SAFIR-ABC10","aka":[],"tldr":"SAFIR-ABC10 profiles the tumour during first-line chemotherapy and then randomises people with a targetable change to a matched drug (for HER2, FGFR2, IDH1, BRAF or DNA repair defects) or to standard continuation. With 20 NHS hospitals taking part, it is the biggest precision-medicine trial open to UK patients with gallbladder cancer.","summary":"SAFIR-ABC10 (NCT05615818) is an international, randomised, controlled, open-label platform phase 3 led by UNICANCER at 69 sites in France, Belgium and the United Kingdom, open since July 2024 with 800 patients planned and primary completion listed for June 2027. Patients with histologically proven intrahepatic, perihilar or distal cholangiocarcinoma or gallbladder carcinoma (ampullary carcinoma excluded) undergo molecular profiling during induction gemcitabine and cisplatin; those with an actionable alteration are randomised to matched maintenance therapy or to standard of care. The registry lists futibatinib, ivosidenib, zanidatamab, trastuzumab, neratinib, encorafenib, binimetinib, niraparib, cisplatin and gemcitabine as interventions, covering FGFR2, IDH1, HER2, BRAF and homologous recombination alterations. The primary endpoint is progression-free survival. For gallbladder cancer, whose actionable alteration is most often HER2, the trial is the main randomised route to zanidatamab or trastuzumab-based maintenance in the UK outside HERIZON-BTC-302.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05615818","url":"https://clinicaltrials.gov/study/NCT05615818"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cgp","kinase-inhibitors","bispecific-antibody","parp-inhibitor","cytotoxic-chemotherapy"],"targets":["her2","fgfr2","idh","braf"],"drugs":["futibatinib","ivosidenib","zanidatamab","trastuzumab","neratinib","niraparib","gemcitabine-cisplatin"],"companies":["unicancer"],"institutions":["uclh","royal-marsden","leeds-cancer-centre"],"pathways":[],"terms":["basket-umbrella-platform","master-protocol"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (20, registry): Queen Elizabeth Hospital (Birmingham); Bristol Haematology and Oncology Centre; Addenbrooke's (Cambridge); Castle Hill Hospital (Cottingham); St James's (Leeds); Clatterbridge Cancer Centre (Liverpool); Guy's and St Thomas', Hammersmith, Royal Free, Royal Marsden and University College London (London); Maidstone Hospital; The Christie (Manchester); Mount Vernon Cancer Centre (Northwood); Nottingham University Hospital; Churchill Hospital (Oxford) and others."],"nct":"NCT05615818","phase":"3","setting":"Advanced biliary cancer (intrahepatic, perihilar or distal cholangiocarcinoma, or gallbladder carcinoma) after induction gemcitabine and cisplatin: molecular targeted maintenance therapy matched to the tumour's alteration versus standard of care, international platform phase 3","sponsor":"UNICANCER","started":"2024-07-18","startedType":"actual","enrolled":800,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06737081","kind":"trial","name":"SAL-0951 in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies","aka":[],"tldr":"A phase 2 trial of SAL-0951 tablets 4mg in advanced solid tumours, run by Shenzhen Salubris Pharmaceuticals Co., Ltd., now recruiting.","summary":"SAL-0951 in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies is a phase 2 interventional study registered as NCT06737081 by Shenzhen Salubris Pharmaceuticals Co., Ltd., with 60 participants planned, started 2024-09-14 and due to reach its primary completion in 2025-12-31. Interventions recorded: SAL-0951 tablets 4mg and SAL-0951 tablets 5mg.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06737081","url":"https://clinicaltrials.gov/study/NCT06737081"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06737081","phase":"2","setting":"A Parallel, Open-label Phase II Clinical Study of Enarodustat (SAL-0951) Tablets in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies","sponsor":"Shenzhen Salubris Pharmaceuticals Co., Ltd.","started":"2024-09-14","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04589234","kind":"trial","name":"Saltikva for Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of Gemcitabine and Gemcitabine + nab-paclitaxel in pancreatic ductal adenocarcinoma, run by Salspera LLC, active and no longer recruiting.","summary":"Saltikva for Metastatic Pancreatic Cancer is a phase 2 interventional study registered as NCT04589234 by Salspera LLC, with 60 participants enrolled, started 2020-10-20 and due to reach its primary completion in 2030-12-31. Interventions recorded: Salmonella-IL2, FOLFIRINOX Alone (Historical Controls) and Gemcitabine/Abraxane Alone (Historical Controls).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04589234","url":"https://clinicaltrials.gov/study/NCT04589234"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["gemcitabine","gemcitabine-nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04589234","phase":"2","setting":"A Phase 2 Study of Saltikva (Attenuated Salmonella Typhimurium Containing the Human Gene for Interleukin-2) in Patients With Metastatic Pancreatic Cancer","sponsor":"Salspera LLC","started":"2020-10-20","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00551525","kind":"trial","name":"Samarium Sm 153 Lexidronam Pentasodium and 3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Rising Prostate-Specific Antigen Levels After Radical Prostatectomy for Prostate Cancer","aka":[],"tldr":"A phase 2 trial of Samarium-153 lexidronam in Prostate cancer, run by Radiation Therapy Oncology Group, completed.","summary":"Samarium Sm 153 Lexidronam Pentasodium and 3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Rising Prostate-Specific Antigen Levels After Radical Prostatectomy for Prostate Cancer is a phase 2 interventional study registered as NCT00551525 by Radiation Therapy Oncology Group, with 67 participants recorded, started 2008-04 and reaching its primary completion in 2014-07. Interventions recorded: Radiotherapy, Samarium 153. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Samarium-153 lexidronam because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00551525","url":"https://clinicaltrials.gov/study/NCT00551525"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["samarium-153-lexidronam"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00551525","phase":"2","setting":"A Phase II Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy","sponsor":"Radiation Therapy Oncology Group","started":"2008-04","yearReported":2017,"enrolled":67,"enrolledBasis":"registry","outcomes":[{"endpoint":"Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration","primary":true,"unit":"%","arms":[{"name":"Radiotherapy + Samarium 153","n":52,"value":7,"note":"Figures from the ClinicalTrials.gov results section (first posted 2017-07-25), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00551525?tab=results"}]},{"id":"nct06258525","kind":"trial","name":"SAMe in Prevention of Oxaliplatin-associated Liver Injury","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Cedars-Sinai Medical Center, not yet recruiting.","summary":"SAMe in Prevention of Oxaliplatin-associated Liver Injury is a phase 2, interventional study registered as NCT06258525 by Cedars-Sinai Medical Center, with a registry enrolment figure of 30 participants, started 2026-07 and due to reach its primary completion in 2028-08. Interventions recorded: Standard of care oxaliplatin-based chemotherapy; S-adenosylmethionine (SAMe) supplement; Surgery. Conditions listed: Colorectal Cancer; Liver Metastases; Liver Metastasis Colon Cancer; Liver Injury; Sinusoidal Obstruction Syndrome; 5-Fluorouracil Toxicity; Liver Toxicity, Chemically-Induced. Primary outcome: To evaluate the efficacy of SAMe in preventing oxaliplatin associated liver injury as determined by lack of injury on histopathologic analysis in patients with liver only stage IV colorectal cancer.. Colorectal eligibility wording from the registry: \"* Stage IV patients with resectable liver predominant metastatic colorectal cancer (new diagnosis or recurrent) referred to Cedars Sinai Medical Center for oxaliplatin based systemic therapy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06258525","url":"https://clinicaltrials.gov/study/NCT06258525"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06258525","phase":"2","setting":"A Phase II, Open-Label Trial of S-Adenosylmethionine (SAMe) in Prevention of Oxaliplatin Associated Liver Injury","sponsor":"Cedars-Sinai Medical Center","started":"2026-07","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07665684","kind":"trial","name":"Samuraciclib in Combination With Gemcitabine/Nab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer","aka":["SONIC"],"tldr":"A phase 1/2 trial in pancreatic cancer, run by University Health Network, Toronto, not yet recruiting.","summary":"Samuraciclib in Combination With Gemcitabine/Nab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer is a phase 1/2, interventional study registered as NCT07665684 by University Health Network, Toronto, with a registry enrolment figure of 67 participants, started 2026-07 and due to reach its primary completion in 2029-05. Interventions recorded: Samuraciclib + Gemcitabine & Nab-Paclitaxel. Conditions listed: Pancreas Ductal Adenocarcinoma; Pancreas Cancer, Metastatic; Pancreatic Adenocarcinoma Metastatic; Adenosquamous Carcinoma of the Pancreas; Mucinous Adenocarcinoma. Primary outcome: Frequencies of adverse events (AEs), as graded by CTCAE v6.0 and reported by dose level; Percentages of adverse events (AEs), as graded by CTCAE v6.0 and reported by dose level; Frequencies of dose-limiting toxicities reported by dose level. Pancreatic eligibility wording from the registry: \"Known homologous recombination deficient pancreatic cancer, including germline or somatic BRCA1/2 or PALB2 mutations\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07665684","url":"https://clinicaltrials.gov/study/NCT07665684"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac","brca-palb2-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07665684","phase":"1/2","setting":"Phase Ib/II Study of Samuraciclib in Combination With Gemcitabine/Nab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer","sponsor":"University Health Network, Toronto","started":"2026-07","startedType":"estimated","enrolled":67,"enrolledBasis":"registry","outcomes":[]},{"id":"sanet","kind":"trial","name":"SANET-ep and SANET-p","aka":[],"tldr":"In the SANET trials, a Chinese anti-angiogenic pill slowed both gut and pancreatic neuroendocrine tumours, but its US application was refused.","summary":"SANET-ep and SANET-p, led by trial NCT02588170 and sponsored by Hutchmed, showed in 2020 that the Chinese anti-angiogenic tablet surufatinib slows both extra-pancreatic and pancreatic neuroendocrine tumours, but its US application was refused. The two trials randomised 198 patients with extra-pancreatic and 172 with pancreatic progressive tumours to surufatinib or placebo in China, and both met their primary progression-free survival endpoints with large effects, leading to approval in China in 2020 and 2021, while the FDA issued a complete response letter in 2022 requiring a multiregional trial. OnCo links them to neuroendocrine tumours, anti-angiogenic therapy and VEGF and VEGFR as targets. Whether a single-country trial can ever support a US approval is the wider question the refusal raised.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02588170","url":"https://clinicaltrials.gov/study/NCT02588170"}],"tags":["lesson:single-region-data"],"related":[],"cancers":["neuroendocrine"],"sections":[],"technologies":["antiangiogenic"],"targets":["vegf"],"drugs":["surufatinib"],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02588170","phase":"3","setting":"Progressive extra-pancreatic (n=198) and pancreatic (n=172) NETs: surufatinib vs placebo (China)","sponsor":"Hutchmed","result":"PFS HR 0.33 (ep), 0.49 (p).","started":"2015-12-07","startedType":"actual","yearReported":2020,"enrolled":369,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (SANET-ep)","primary":true,"unit":"months","arms":[{"name":"Surufatinib","value":9.2},{"name":"Placebo","value":3.8}],"hr":0.33,"source":"https://doi.org/10.1016/S1470-2045(20)30496-4"},{"endpoint":"Progression-free survival (SANET-p)","primary":true,"unit":"months","arms":[{"name":"Surufatinib","value":10.9},{"name":"Placebo","value":3.7}],"hr":0.49,"source":"https://doi.org/10.1016/S1470-2045(20)30493-9"}]},{"id":"sano","kind":"trial","name":"SANO","aka":[],"tldr":"For the third of patients whose tumour vanishes after chemoradiation, watching closely and operating only if it comes back gave the same survival as immediate surgery.","summary":"Stepped-wedge cluster-randomised non-inferiority trial (Lancet Oncology 2025). Two-year OS non-inferior (HR 1.14, 95% CI 0.74-1.78); about a third of surveillance patients avoided oesophagectomy at 2 years, with better short-term quality of life. Regrowth was usually resectable. Establishes organ preservation as an option for cCR, with caveats about surveillance intensity.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05953181","url":"https://clinicaltrials.gov/study/NCT05953181"},{"label":"Lancet Oncology 2025","url":"https://www.sciencedirect.com/science/article/abs/pii/S1470204525000270"}],"tags":[],"related":[],"cancers":["esophageal"],"sections":[],"technologies":["active-surveillance","imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["clinical-complete-response"],"trials":["cross"],"people":["jan-van-lanschot"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05953181","phase":"3","setting":"Oesophageal cancer with clinical complete response after CROSS chemoradiation: active surveillance (surgery only on regrowth) vs standard surgery","sponsor":"Erasmus MC","result":"2-year OS non-inferior (HR 1.14); ~one-third avoided surgery.","started":"2017-11-01","startedType":"actual","yearReported":2023,"enrolled":309,"enrolledBasis":"analysed","enrolledNote":"ClinicalTrials.gov lists 776 participants (actual); the Lancet Oncology 2025 paper reports 1,115 individuals screened and 309 included in the analysis (198 active surveillance, 111 standard surgery).","outcomes":[{"endpoint":"Overall survival at 2 years (non-inferiority)","primary":true,"arms":[{"name":"Active surveillance","n":156},{"name":"Standard surgery","n":118}],"hr":1.14,"ci":[0.74,1.78],"p":"0.55","source":"https://www.sciencedirect.com/science/article/abs/pii/S1470204525000270"}],"replication":"Consistent with preSANO and observational series; longer follow-up pending."},{"id":"nct07558733","kind":"trial","name":"Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer","aka":["PIKTOR"],"tldr":"A phase 1/2 trial of Serabelisib, Sapanisertib and Fulvestrant in advanced solid tumours, run by Faeth Therapeutics, now recruiting.","summary":"Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer is a phase 1/2 interventional study registered as NCT07558733 by Faeth Therapeutics, with 32 participants planned, started 2026-04-22 and due to reach its primary completion in 2029-05. Interventions recorded: Serabelisib, Sapanisertib and Fulvestrant.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07558733","url":"https://clinicaltrials.gov/study/NCT07558733"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["serabelisib","sapanisertib","fulvestrant"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07558733","phase":"1/2","setting":"Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced or Metastatic Breast Cancer","sponsor":"Faeth Therapeutics","started":"2026-04-22","startedType":"actual","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06463028","kind":"trial","name":"Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial ","aka":["PIKTOR"],"tldr":"A phase 2 trial of Sapanisertib, Serabelisib, Paclitaxel / nab-paclitaxel in endometrial cancer, run by Faeth Therapeutics, now recruiting.","summary":"Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer is a phase 2 interventional study registered as NCT06463028 by Faeth Therapeutics, with 40 participants planned, started 2024-12-12 and due to reach its primary completion in 2028-09. Interventions recorded: Sapanisertib, Serabelisib, Paclitaxel. Conditions listed: Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06463028","url":"https://clinicaltrials.gov/study/NCT06463028"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["sapanisertib","serabelisib","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06463028","phase":"2","setting":"An Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, and a Substudy Evaluating PIKTOR With Paclitaxel Plus an Insulin-Suppressing Diet, in Patients With Advanced or Recurrent Endometrial Cancer","sponsor":"Faeth Therapeutics","started":"2024-12-12","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04154956","kind":"trial","name":"SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients","aka":[],"tldr":"A phase 3 trial of Tusamitamab ravtansine and Docetaxel in Non-small-cell lung cancer, run by Sanofi, recorded as terminated on the registry.","summary":"SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients is a phase 3 interventional study registered as NCT04154956 by Sanofi, with 389 participants recorded, started 2020-02-06 and due to reach its primary completion in 2023-09-22. Interventions recorded: SAR408701, Docetaxel. Conditions recorded: Non-small Cell Lung Cancer Metastatic.\n\nLinked to the drug Tusamitamab ravtansine because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04154956","url":"https://clinicaltrials.gov/study/NCT04154956"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["tusamitamab-ravtansine","docetaxel"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04154956","phase":"3","setting":"Randomized, Open-label, Phase 3 Study of SAR408701 Versus Docetaxel in Previously Treated, Metastatic Nonsquamous, Non-small-cell Lung Cancer Patients With CEACAM5-positive Tumors","sponsor":"Sanofi","started":"2020-02-06","startedType":"actual","yearReported":2024,"enrolled":389,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Tusamitamab Ravtansine","n":194,"value":5.39,"note":"95% CI 3.713 to 6.998; Figures from the ClinicalTrials.gov results section (first posted 2024-11-01), not from a publication"},{"name":"Docetaxel","n":195,"value":5.85,"note":"95% CI 5.520 to 7.359"}],"hr":1.143,"ci":[0.864,1.512],"p":"0.8204","source":"https://clinicaltrials.gov/study/NCT04154956?tab=results"},{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Tusamitamab Ravtansine","n":194,"value":12.81,"note":"95% CI 11.795 to 14.160; Figures from the ClinicalTrials.gov results section (first posted 2024-11-01), not from a publication"},{"name":"Docetaxel","n":195,"value":11.53,"note":"95% CI 8.936 to 15.244"}],"hr":0.846,"ci":[0.644,1.109],"p":"0.1120","source":"https://clinicaltrials.gov/study/NCT04154956?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"Tusamitamab Ravtansine","n":189,"value":21.7,"note":"95% CI 16.04 to 28.26; Figures from the ClinicalTrials.gov results section (first posted 2024-11-01), not from a publication"},{"name":"Docetaxel","n":187,"value":24.1,"note":"95% CI 18.13 to 30.84"}],"p":"0.6972","source":"https://clinicaltrials.gov/study/NCT04154956?tab=results"}]},{"id":"sarah-sirvenib","kind":"trial","name":"SARAH and SIRveNIB","aka":[],"tldr":"Two large trials found radioactive beads were gentler than sorafenib but did not help patients live longer.","summary":"SARAH and SIRveNIB, led by trial NCT01482442 and sponsored by AP-HP and the National Cancer Centre Singapore, were two large trials reported in 2017 that found yttrium-90 radioembolisation was gentler than sorafenib in locally advanced hepatocellular carcinoma but did not help patients live longer. SARAH randomised 459 patients and SIRveNIB 360, and neither improved overall survival, although the radioactive beads gave better quality of life and more responses. OnCo links them to hepatocellular carcinoma, radioembolisation and sorafenib. The results were interpreted as showing the need for personalised dosimetry and earlier-stage use rather than the failure of the modality, and whether dosimetry-guided radioembolisation can succeed where fixed dosing did not is the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01482442","url":"https://clinicaltrials.gov/study/NCT01482442"}],"tags":["failure","lesson:patient-selection"],"related":[],"cancers":["hcc"],"sections":[],"technologies":["radioembolisation-tare"],"targets":[],"drugs":["sorafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01482442","phase":"3","setting":"Locally advanced HCC: yttrium-90 radioembolisation vs sorafenib","sponsor":"AP-HP (SARAH); NCC Singapore (SIRveNIB)","result":"OS not improved; fewer adverse events.","started":"2011-12","yearReported":2017,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (SARAH)","primary":true,"unit":"months","arms":[{"name":"Y-90 SIRT","n":237,"value":8},{"name":"Sorafenib","n":222,"value":9.9}],"hr":1.15,"source":"https://doi.org/10.1016/S1470-2045(17)30683-6"}]},{"id":"sarc028","kind":"trial","name":"SARC028","aka":[],"tldr":"SARC028 tested the immunotherapy pembrolizumab across the common sarcoma types and found that it works in some, undifferentiated pleomorphic sarcoma above all, and barely at all in bone sarcomas such as osteosarcoma and Ewing sarcoma.","summary":"SARC028 was a multicentre phase 2 study of pembrolizumab in adults with advanced soft tissue sarcoma (undifferentiated pleomorphic sarcoma, dedifferentiated liposarcoma, synovial sarcoma and leiomyosarcoma) and bone sarcoma (osteosarcoma, Ewing sarcoma and chondrosarcoma). The primary endpoint was objective response rate.\n\nResponses were concentrated in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, which led to expansion cohorts that confirmed the signal in the former, while synovial sarcoma, leiomyosarcoma and the bone sarcomas showed little activity. The trial identified undifferentiated pleomorphic sarcoma as the sarcoma most likely to respond to checkpoint blockade and set up the neoadjuvant SU2C-SARC032 trial of pembrolizumab with radiotherapy.","status":"mixed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02301039","url":"https://clinicaltrials.gov/study/NCT02301039"}],"tags":["subtype-trials"],"related":[],"cancers":["undifferentiated-pleomorphic-sarcoma","liposarcoma","osteosarcoma","ewing-sarcoma","sarcoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck","sarc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["hussein-tawbi"],"bottlenecks":[],"keyPapers":["paper-sarc028-pembrolizumab-sarcoma-tawbi-lancet-oncol-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02301039","phase":"2","setting":"Advanced soft tissue and bone sarcomas: single-arm pembrolizumab, with expansion cohorts in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma","sponsor":"Sarcoma Alliance for Research through Collaboration (SARC)","result":"Pembrolizumab produced objective responses mainly in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, with little activity in bone sarcomas.","started":"2015-03","startedType":"actual","yearReported":2017,"enrolled":144,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response (investigator-assessed), soft-tissue sarcoma cohort","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":40,"value":18,"note":"Median follow-up 17.8 months"}],"source":"https://doi.org/10.1016/S1470-2045(17)30624-1"},{"endpoint":"Objective response (investigator-assessed), bone sarcoma cohort","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":40,"value":5}],"source":"https://doi.org/10.1016/S1470-2045(17)30624-1"},{"endpoint":"Objective response, undifferentiated pleomorphic sarcoma","unit":"%","arms":[{"name":"Pembrolizumab","n":10,"value":40}],"source":"https://doi.org/10.1016/S1470-2045(17)30624-1"},{"endpoint":"Objective response, liposarcoma","unit":"%","arms":[{"name":"Pembrolizumab","n":10,"value":20}],"source":"https://doi.org/10.1016/S1470-2045(17)30624-1"}]},{"id":"nct04977024","kind":"trial","name":"SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer","aka":[],"tldr":"A phase 2 trial of COVID-19 Vaccine in non-Hodgkin lymphoma and multiple myeloma, run by GeoVax, Inc., active and no longer recruiting.","summary":"SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer is a phase 2 interventional study registered as NCT04977024 by GeoVax, Inc., with 63 participants enrolled, started 2021-09-27 and due to reach its primary completion in 2026-12-31. Interventions recorded: COVID-19 Vaccine and Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04977024","url":"https://clinicaltrials.gov/study/NCT04977024"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04977024","phase":"2","setting":"A Phase 2 Randomized, Multi-center Study of GEO-CMO4S1 (SARS-CoV-2 Vaccine) Versus mRNA SARS-CoV-2 Vaccine in Patients Post Cellular Therapy for Hematological Malignancies","sponsor":"GeoVax, Inc.","started":"2021-09-27","startedType":"actual","enrolled":63,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06380751","kind":"trial","name":"Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer","aka":["EvoPAR-Breast01"],"tldr":"A phase 3 trial of Saruparib, Camizestrant, Abemaciclib, Ribociclib, Palbociclib and Fulvestrant in HR-positive / HER2-negative breast cancer, run by AstraZeneca, now recruiting.","summary":"Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer is a phase 3 interventional study registered as NCT06380751 by AstraZeneca, with 788 participants planned, started 2024-08-01 and due to reach its primary completion in 2029-12-18. Interventions recorded: Saruparib (AZD5305), Camizestrant, Abemaciclib, Ribociclib, Palbociclib and Fulvestrant.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06380751","url":"https://clinicaltrials.gov/study/NCT06380751"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["saruparib","camizestrant","abemaciclib","ribociclib","palbociclib","fulvestrant"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06380751","phase":"3","setting":"A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)","sponsor":"AstraZeneca","started":"2024-08-01","startedType":"actual","enrolled":788,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06120491","kind":"trial","name":"Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents","aka":["EvoPAR-Prostate01"],"tldr":"A phase 3 trial testing Saruparib in prostate cancer, active and no longer recruiting.","summary":"Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents is a phase 3 interventional study registered as NCT06120491, led by AstraZeneca, and active but no longer recruiting on the registry. Official title: A Randomised, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01). Planned enrolment is 1898 participants (actual). The study started in 2023-11-21 and primary completion is expected in 2027-09-30. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06120491","url":"https://clinicaltrials.gov/study/NCT06120491"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":[],"targets":[],"drugs":["saruparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06120491","phase":"3","setting":"A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)","sponsor":"AstraZeneca","started":"2023-11-21","startedType":"actual","enrolled":1898,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05374603","kind":"trial","name":"Savolitinib Combine With Durvalumab in EGFR Wild-type Locally Advanced or Metastatic NSCLC","aka":["SOUND"],"tldr":"A phase 2 trial of Savolitinib and Durvalumab in advanced solid tumours, run by AstraZeneca, active and no longer recruiting.","summary":"Savolitinib Combine With Durvalumab in EGFR Wild-type Locally Advanced or Metastatic NSCLC is a phase 2 interventional study registered as NCT05374603 by AstraZeneca, with 47 participants enrolled, started 2022-11-15 and due to reach its primary completion in 2027-01-18. Interventions recorded: Savolitinib and Durvalumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05374603","url":"https://clinicaltrials.gov/study/NCT05374603"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["savolitinib","durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05374603","phase":"2","setting":"Savolitinib Combine With Durvalumab in Chinese EGFR Wild-type Locally Advanced or Metastatic NSCLC Patients With MET Alteration: An Open-label, Interventional, Multiple-center, Exploratory Trial (SOUND)","sponsor":"AstraZeneca","started":"2022-11-15","startedType":"actual","enrolled":47,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07683403","kind":"trial","name":"Savolitinib Plus Cetuximab and FOLFOX Chemotherapy for RAS/BRAF Wild-type Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"Savolitinib Plus Cetuximab and FOLFOX Chemotherapy for RAS/BRAF Wild-type Metastatic Colorectal Cancer is a phase 1/2, randomised interventional study registered as NCT07683403 by Fudan University, with a registry enrolment figure of 138 participants, started 2026-06-30 and due to reach its primary completion in 2028-06-30. Interventions recorded: Savolitinib plus cetuximab and FOLFOX chemotherapy; Cetuximab and FOLFOX chemotherapy. Conditions listed: Colorectal Cancer (CRC). Primary outcome: Objective response rate (ORR). Colorectal eligibility wording from the registry: \"Histologically confirmed unresectable locally advanced or metastatic colorectal cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07683403","url":"https://clinicaltrials.gov/study/NCT07683403"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07683403","phase":"1/2","setting":"Savolitinib Plus Cetuximab and FOLFOX Chemotherapy Versus Cetuximab and FOLFOX Chemotherapy as First-line Treatment for RAS/BRAF Wild-type Metastatic Colorectal Cancer: a Prospective, Randomized, Controlled, Multicenter, Open-label Study","sponsor":"Fudan University","started":"2026-06-30","startedType":"estimated","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05043090","kind":"trial","name":"Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC","aka":["SAMETA"],"tldr":"A phase 3 trial of Savolitinib, Durvalumab, Sunitinib in renal cell carcinoma, run by AstraZeneca, active and no longer recruiting.","summary":"Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC is a phase 3 interventional study registered as NCT05043090 by AstraZeneca, with 148 participants enrolled, started 2021-10-28 and due to reach its primary completion in 2025-12-31. Interventions recorded: savolitinib, durvalumab, sunitinib. Conditions listed: Papillary Renal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05043090","url":"https://clinicaltrials.gov/study/NCT05043090"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc","papillary-rcc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["savolitinib","durvalumab","sunitinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05043090","phase":"3","setting":"A Phase III, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (SAMETA)","sponsor":"AstraZeneca","started":"2021-10-28","startedType":"actual","enrolled":148,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05261399","kind":"trial","name":"Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment","aka":["SAFFRON"],"tldr":"A phase 3 trial of Savolitinib, Osimertinib, Pemetrexed, Cisplatin and Carboplatin in non-small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment is a phase 3 interventional study registered as NCT05261399 by AstraZeneca, with 341 participants enrolled, started 2022-08-03 and due to reach its primary completion in 2026-07-06. Interventions recorded: Savolitinib, Osimertinib, Pemetrexed, Cisplatin and Carboplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05261399","url":"https://clinicaltrials.gov/study/NCT05261399"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["savolitinib","osimertinib","pemetrexed","cisplatin","carboplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05261399","phase":"3","setting":"A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON).","sponsor":"AstraZeneca","started":"2022-08-03","startedType":"actual","enrolled":341,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03091192","kind":"trial","name":"Savolitinib vs. Sunitinib in MET-driven PRCC.","aka":[],"tldr":"A phase 3 trial of Savolitinib and Sunitinib in renal cell carcinoma, run by AstraZeneca, active and no longer recruiting.","summary":"Savolitinib vs. Sunitinib in MET-driven PRCC. is a phase 3 interventional study registered as NCT03091192 by AstraZeneca, with 60 participants enrolled, started 2017-07-25 and due to reach its primary completion in 2019-08-18. Interventions recorded: Savolitinib and Sunitinib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03091192","url":"https://clinicaltrials.gov/study/NCT03091192"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc","papillary-rcc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["savolitinib","sunitinib"],"companies":["astrazeneca","hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03091192","phase":"3","setting":"A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study To Assess the Efficacy and Safety of Savolitinib Versus Sunitinib in Patients With MET-Driven, Unresectable and Locally Advanced, Or Metastatic Papillary Renal Cell Carcinoma (PRCC)","sponsor":"AstraZeneca","started":"2017-07-25","startedType":"actual","yearReported":2020,"enrolled":60,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)","primary":true,"unit":"months","arms":[{"name":"Savolitinib QD","n":33,"value":7,"note":"95% CI 2.8 to NA; Figures from the ClinicalTrials.gov results section (first posted 2020-07-10), not from a publication"},{"name":"Sunitinib QD","n":27,"value":5.6,"note":"95% CI 4.1 to 6.9"}],"hr":0.71,"ci":[0.37,1.36],"p":"0.313","source":"https://clinicaltrials.gov/study/NCT03091192?tab=results"}]},{"id":"nct06767007","kind":"trial","name":"SBRT + PD-1 Antibody in Unresectable Locally Recurrent Rectal Cancer（SPARKLE）","aka":["SPARKLE"],"tldr":"A phase 2 trial in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"SBRT + PD-1 Antibody in Unresectable Locally Recurrent Rectal Cancer（SPARKLE） is a phase 2, interventional study registered as NCT06767007 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 31 participants, started 2025-01-06 and due to reach its primary completion in 2026-11-30. Interventions recorded: Stereotactic Body Radiation Therapy (SBRT); PD1; Chemotherapy. Conditions listed: Unresectable Locally Recurrent Rectal Cancer. Primary outcome: 1 year PFS. Colorectal eligibility wording from the registry: \"Patients with pMMR/MSS colorectal cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06767007","url":"https://clinicaltrials.gov/study/NCT06767007"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06767007","phase":"2","setting":"Evaluation of the Efficiency and Safety of Stereotactic Body Radiation Therapy Combined With PD-1 Antibody in the Treatment of Unresectable Locally Recurrent Rectal Cancer: A Prospective, Multicenter, Single-Arm, Open Label, Phase II Study","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2025-01-06","startedType":"actual","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06794086","kind":"trial","name":"SBRT + PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases","aka":["SPARKLE-L"],"tldr":"A phase 3 trial in colorectal cancer, run by Jun Huang, now recruiting.","summary":"SBRT + PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases is a phase 3, interventional study registered as NCT06794086 by Jun Huang, with a registry enrolment figure of 24 participants, started 2025-04-10 and due to reach its primary completion in 2026-06-20. Interventions recorded: Stereotactic body radiation therapy; PD-1 Monoclonal Antibody; Chemotherapy. Conditions listed: Colorectal Cancer; Liver Metastases. Primary outcome: ORR. Colorectal eligibility wording from the registry: \"Patients with pMMR/MSS colorectal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06794086","url":"https://clinicaltrials.gov/study/NCT06794086"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06794086","phase":"3","setting":"SBRT Combined With PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases: A Prospective, Multicenter, Single-arm, Phase II Clinical Study (SPARKLE-L)","sponsor":"Jun Huang","started":"2025-04-10","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06835179","kind":"trial","name":"SBRT Combined With CAPEOX, Bevacizumab, and PD-1 Inhibitor for the Treatment of RAS-Mutant, MSS-Type, Unresectable Metastatic Colorectal Cancer.","aka":[],"tldr":"A phase 2 trial of cAPOX (capecitabine, oxaliplatin) and bevacizumab (glioblastoma use) in colorectal cancer, run by The First Affiliated Hospital with Nanjing Medical University, not yet recruiting.","summary":"SBRT Combined With CAPEOX, Bevacizumab, and PD-1 Inhibitor for the Treatment of RAS-Mutant, MSS-Type, Unresectable Metastatic Colorectal Cancer. is a phase 2, interventional study registered as NCT06835179 by The First Affiliated Hospital with Nanjing Medical University, with a registry enrolment figure of 28 participants, started 2025-02 and due to reach its primary completion in 2027-02. Interventions recorded: SBRT; PD-1 Inhibitors; CapeOX + bevacizumab. Conditions listed: Unresectable Metastatic Colorectal Cancer; Microsatellite Stable (MSS) Colorectal Cancer (CRC); RAS-mutant Colorectal Cancer. Primary outcome: Objective response rate (ORR rate). Colorectal eligibility wording from the registry: \"* Histologically confirmed colorectal adenocarcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06835179","url":"https://clinicaltrials.gov/study/NCT06835179"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","sbrt"],"targets":[],"drugs":["capox","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06835179","phase":"2","setting":"Evaluation of the Efficacy and Safety of SBRT Combined With CAPEOX, Bevacizumab, and PD-1 Inhibitor in RAS-Mutant, MSS-Type, and Unresectable Metastatic Colorectal Cancer: a Single-center, Single-arm, Open-label Clinical Trail.","sponsor":"The First Affiliated Hospital with Nanjing Medical University","started":"2025-02","startedType":"estimated","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05747716","kind":"trial","name":"SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, not yet recruiting.","summary":"SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC is a phase 2, interventional study registered as NCT05747716 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 44 participants, started 2023-02-28 and due to reach its primary completion in 2026-12-31. Interventions recorded: SBRT, Fruquintinib, Cadonilimab. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Progression free survival. Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05747716","url":"https://clinicaltrials.gov/study/NCT05747716"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05747716","phase":"2","setting":"SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody Cadonilimab for Third-line Treatment in Metastatic Colonrectal Cancer.","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2023-02-28","startedType":"estimated","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06627712","kind":"trial","name":"SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC","aka":[],"tldr":"A phase 3 trial in triple-negative breast cancer, run by West China Hospital, now recruiting.","summary":"SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC is a phase 3, randomised interventional study registered as NCT06627712 by West China Hospital, with a registry enrolment figure of 318 participants, started 2024-11-01 and due to reach its primary completion in 2029-11-01. Interventions recorded: SBRT+PD-1 Inhibitor + Chemotherapy; PD-1 Inhibitor + Chemotherapy. Conditions listed: TNBC - Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Histologically or cytologically confirmed TNBC (ER-, PR-, HER2-)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06627712","url":"https://clinicaltrials.gov/study/NCT06627712"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06627712","phase":"3","setting":"Stereotactic Body Radiotherapy (SBRT) Combined With PD-1 Inhibitor and Chemotherapy in Early-stage Treatment-naive Triple-negative Breast Cancer Patients: A Multicenter Phase III Clinical Study","sponsor":"West China Hospital","started":"2024-11-01","startedType":"actual","enrolled":318,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06009029","kind":"trial","name":"SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)","aka":["SPARK-1"],"tldr":"A phase 2 trial of zimberelimab in pancreatic cancer, run by Peking University Third Hospital, not yet recruiting.","summary":"SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study) is a phase 2, interventional study registered as NCT06009029 by Peking University Third Hospital, with a registry enrolment figure of 96 participants, started 2023-08 and due to reach its primary completion in 2026-07. Interventions recorded: Stereotactic body radiation(SBRT); Zimberelimab (GLS-010). Conditions listed: Locally Advanced Pancreatic Cancer. Primary outcome: Overall survival (OS). Pancreatic eligibility wording from the registry: \"* Locally advanced pancreatic cancer confirmed histologically and defined according to the NCCN Pancreatic Cancer Guidelines v1\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06009029","url":"https://clinicaltrials.gov/study/NCT06009029"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":["zimberelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06009029","phase":"2","setting":"A Multicenter, Single-arm, Prospective Study of SBRT Combined With Zimberelimab (GLS-010) in Patients With Locally Advanced Pancreatic Cancer (SPARK-1 Study)","sponsor":"Peking University Third Hospital","started":"2023-08","startedType":"estimated","enrolled":96,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07683221","kind":"trial","name":"SBRT Followed by Ipilimumab N01, Sintilimab, Nab-Paclitaxel and Gemcitabine for Locally Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of sintilimab and gemcitabine + nab-paclitaxel in pancreatic cancer, run by Shandong Cancer Hospital and Institute, not yet recruiting.","summary":"SBRT Followed by Ipilimumab N01, Sintilimab, Nab-Paclitaxel and Gemcitabine for Locally Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT07683221 by Shandong Cancer Hospital and Institute, with a registry enrolment figure of 47 participants, started 2026-07-15 and due to reach its primary completion in 2029-07-15. Interventions recorded: SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy. Conditions listed: Pancreatic Cancer. Primary outcome: Progression-Free Survival (PFS). Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07683221","url":"https://clinicaltrials.gov/study/NCT07683221"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","sbrt"],"targets":[],"drugs":["sintilimab","gemcitabine-nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07683221","phase":"2","setting":"Stereotactic Body Radiotherapy Followed by Ipilimumab N01 Plus Sintilimab in Combination With Nab-Paclitaxel and Gemcitabine for the Treatment of Locally Advanced Pancreatic Cancer: A Phase II, Prospective, Single-Arm Exploratory Clinical Trial","sponsor":"Shandong Cancer Hospital and Institute","started":"2026-07-15","startedType":"estimated","enrolled":47,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07535632","kind":"trial","name":"SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cancer","aka":["BEST"],"tldr":"A phase 2 trial of sintilimab and bevacizumab (glioblastoma use) in colorectal cancer, run by Shanghai Zhongshan Hospital, not yet recruiting.","summary":"SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07535632 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 58 participants, started 2026-06-01 and due to reach its primary completion in 2028-06-01. Interventions recorded: SBRT; Sintilimab; Bevacizumab; Trifluridine and Tipiracil Tablets; Standard of Care (Investigator Selected). Conditions listed: Colorectal Neoplasms. Primary outcome: Progression-Free Survival (PFS). Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed colorectal cancer with unresectable metastatic or recurrent lesions\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07535632","url":"https://clinicaltrials.gov/study/NCT07535632"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","sbrt"],"targets":[],"drugs":["sintilimab","bevacizumab-glioma"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07535632","phase":"2","setting":"A Phase II Clinical Study on the Efficacy of Stereotactic Body Radiation Therapy Sequential Combined With Bevacizumab and Trifluridine/Tipiracil in the Treatment of Recurrent Metastatic Colorectal Cancer(BEST)","sponsor":"Shanghai Zhongshan Hospital","started":"2026-06-01","startedType":"estimated","enrolled":58,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05775146","kind":"trial","name":"SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by AHS Cancer Control Alberta, now recruiting.","summary":"SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases is a phase 2, interventional study registered as NCT05775146 by AHS Cancer Control Alberta, with a registry enrolment figure of 24 participants, started 2024-06-18 and due to reach its primary completion in 2028-06-30. Interventions recorded: stereotactic body radiation treatment (SBRT). Conditions listed: Colorectal Cancer; Liver Metastasis Colon Cancer. Primary outcome: Progression free survival (PFS). Colorectal eligibility wording from the registry: \"* Colon cancer patients who have undergone upfront resection of primary colonic lesion can be included\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05775146","url":"https://clinicaltrials.gov/study/NCT05775146"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05775146","phase":"2","setting":"Phase II Single Arm Feasibility Trial to Evaluate Stereotactic Ablative Radiation of Metastases for the Management of Colorectal Cancer With Synchronous Oligo-metastases in Liver","sponsor":"AHS Cancer Control Alberta","started":"2024-06-18","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06401005","kind":"trial","name":"SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)","aka":[],"tldr":"A phase 2 trial of cadonilimab in triple-negative breast cancer, run by Hubei Cancer Hospital, now recruiting.","summary":"SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC) is a phase 2, interventional study registered as NCT06401005 by Hubei Cancer Hospital, with a registry enrolment figure of 51 participants, started 2024-11-28 and due to reach its primary completion in 2026-08-31. Interventions recorded: Cadonilimab (AK104). Conditions listed: Breast Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06401005","url":"https://clinicaltrials.gov/study/NCT06401005"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cadonilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06401005","phase":"2","setting":"A Single-arm, Open, Phase II Clinical Study of SBRT, Chemotherapy, and Cadonilimab (AK104) Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)","sponsor":"Hubei Cancer Hospital","started":"2024-11-28","startedType":"estimated","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"scalop","kind":"trial","name":"SCALOP","aka":["SCALOP-1","Selective Chemoradiation in Advanced Localised Pancreatic cancer"],"tldr":"SCALOP is the UK trial that decided which chemotherapy to give with radiotherapy for pancreatic cancer that cannot be removed: after three months of induction chemotherapy, capecitabine during radiotherapy gave longer survival and far less blood toxicity than gemcitabine, and it is the radiosensitiser NICE recommends.","summary":"SCALOP registered 114 patients between December 2009 and October 2011 and randomised 74 (36 to capecitabine-based and 38 to gemcitabine-based chemoradiotherapy) after induction gemcitabine and capecitabine. Nine-month progression-free survival was 62.9 percent (80 percent confidence interval 50.6 to 73.9) with capecitabine against 51.4 percent (39.4 to 63.4) with gemcitabine; median overall survival 15.2 against 13.4 months (adjusted hazard ratio 0.39, 95 percent confidence interval 0.18 to 0.81; p 0.012) and 12-month survival 79.2 against 64.2 percent. Grade 3 to 4 haematological toxicity during chemoradiotherapy occurred in 18 percent of the gemcitabine arm and none of the capecitabine arm (p 0.008). The long-term analysis (BJC 2017; 105 of 114 patients dead) gave median survival 17.6 against 14.6 months (adjusted hazard ratio 0.68; p 0.185) and identified a CA 19-9 below 46 IU/mL after induction as the marker of patients most likely to benefit from chemoradiotherapy. NICE NG85 recommends capecitabine as the radiosensitiser when chemoradiotherapy is used (1.9.3). SCALOP-2 (159 patients, Oxford) tested higher-dose radiotherapy and nelfinavir after nab-paclitaxel-based induction and had not published its primary results in an indexed journal on 24 September 2026.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01032057","url":"https://clinicaltrials.gov/study/NCT01032057"},{"label":"Mukherjee et al., SCALOP (Lancet Oncology 2013)","url":"https://doi.org/10.1016/S1470-2045(13)70021-4"},{"label":"Hurt et al., SCALOP long-term results (British Journal of Cancer 2017)","url":"https://doi.org/10.1038/bjc.2017.95"},{"label":"ISRCTN96169987: SCALOP","url":"https://www.isrctn.com/ISRCTN96169987"}],"tags":[],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":["chemoradiation","imrt-igrt","cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine","gemcitabine"],"companies":[],"institutions":["cruk"],"pathways":[],"terms":["chemoradiation","ca19-9"],"trials":[],"people":["david-cunningham"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 26): Queen Elizabeth Birmingham, Bristol Haematology and Oncology Centre, Addenbrooke's Cambridge, Queen Alexandra Cosham, Castle Hill Cottingham, Royal Surrey Guildford, St James's Leeds, Leicester Royal Infirmary, Royal Free and Hammersmith London and others. ISRCTN96169987."],"nct":"NCT01032057","phase":"2","setting":"Locally advanced pancreatic cancer of 7 cm or less at 28 UK centres: 12 weeks of gemcitabine plus capecitabine induction, then randomisation of non-progressing patients to one more cycle followed by gemcitabine-based or capecitabine-based chemoradiotherapy (50.4 Gy in 28 fractions), with nine-month progression-free survival as the primary endpoint","sponsor":"Cardiff University (Wales Cancer Trials Unit) with Cancer Research UK","result":"Nine-month progression-free survival 62.9 percent with capecitabine-based against 51.4 percent with gemcitabine-based chemoradiotherapy; median overall survival 15.2 against 13.4 months (adjusted hazard ratio 0.39; p 0.012); grade 3 to 4 haematological toxicity 0 against 18 percent.","started":"2009-07","yearReported":2013,"enrolled":114,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 9 months","primary":true,"unit":"%","arms":[{"name":"Capecitabine-based chemoradiotherapy","n":35,"value":62.9,"note":"80% CI 50.6 to 73.9; 35 assessable"},{"name":"Gemcitabine-based chemoradiotherapy","n":35,"value":51.4,"note":"80% CI 39.4 to 63.4"}],"source":"https://doi.org/10.1016/S1470-2045(13)70021-4"},{"endpoint":"Overall survival (primary report)","unit":"months","arms":[{"name":"Capecitabine-based chemoradiotherapy","n":36,"value":15.2},{"name":"Gemcitabine-based chemoradiotherapy","n":38,"value":13.4}],"hr":0.39,"ci":[0.18,0.81],"p":"0.012","source":"https://doi.org/10.1016/S1470-2045(13)70021-4"}]},{"id":"scalop-2","kind":"trial","name":"SCALOP-2","aka":["SCALOP 2"],"tldr":"SCALOP-2 is the UK follow-on to SCALOP, testing whether a higher radiotherapy dose or the HIV drug nelfinavir improves chemoradiotherapy for pancreatic cancer that cannot be removed; it finished in 2021 and its main results had not appeared in an indexed journal by September 2026.","summary":"SCALOP-2 (ISRCTN50083238, NCT02024009) recruited 159 patients between 2016 and 2021 at 23 UK hospitals from Aberdeen to Colchester, led from the Churchill Cancer Centre in Oxford. After induction gemcitabine and nab-paclitaxel, patients were randomised between standard and high-dose capecitabine-based chemoradiotherapy with or without nelfinavir; the registry lists the trial as completed on 23 June 2021 with progression-free survival and overall survival as primary outcomes. No primary publication was found in Europe PMC on 24 September 2026, so the corpus records the design and status only; with LAP07 and CONKO-007 it is the evidence base for the locally advanced row's statement that chemoradiotherapy is optional.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02024009","url":"https://clinicaltrials.gov/study/NCT02024009"},{"label":"ISRCTN50083238: SCALOP-2","url":"https://www.isrctn.com/ISRCTN50083238"}],"tags":[],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":["chemoradiation","imrt-igrt"],"targets":[],"drugs":["capecitabine","gemcitabine-nab-paclitaxel"],"companies":[],"institutions":["cruk"],"pathways":[],"terms":["chemoradiation","pancreatic-trials-open-today"],"trials":["scalop"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 23): Oxford (Churchill), Aberdeen, Clatterbridge, Belfast City, Bristol, Addenbrooke's Cambridge, Velindre Cardiff, Colchester and others."],"nct":"NCT02024009","phase":"1/2","setting":"Locally advanced non-metastatic pancreatic cancer at 23 UK centres: induction gemcitabine plus nab-paclitaxel, then randomisation to capecitabine-based chemoradiotherapy at standard (50.4 Gy in 28 fractions) or high dose (60 Gy in 30 fractions), with or without the radiosensitiser nelfinavir, with progression-free survival and overall survival as the primary endpoints","sponsor":"University of Oxford, with Cancer Research UK and Celgene","started":"2016-03","startedType":"actual","enrolled":159,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04986579","kind":"trial","name":"Scalp Cooling in MBC","aka":[],"tldr":"A phase 2 trial of Scalp cooling in Breast cancer, run by Dana-Farber Cancer Institute, now recruiting.","summary":"Scalp Cooling in MBC is a phase 2 interventional study registered as NCT04986579 by Dana-Farber Cancer Institute, with 120 participants planned, started 2021-10-07 and due to reach its primary completion in 2028-06-01. Interventions recorded: Paxman Scalp Cooling System, Eribulin, Sacituzumab govitecan, Trastuzumab deruxtecan. Conditions recorded: Metastatic Breast Cancer, Chemotherapy-induced Alopecia.\n\nLinked to the technology Scalp cooling because the registry names it (\"scalp cooling\") among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04986579","url":"https://clinicaltrials.gov/study/NCT04986579"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["scalp-cooling"],"targets":[],"drugs":["eribulin","sacituzumab-govitecan","trastuzumab-deruxtecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04986579","phase":"2","setting":"Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer","sponsor":"Dana-Farber Cancer Institute","started":"2021-10-07","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"scan-b","kind":"trial","name":"SCAN-B (Sweden Cancerome Analysis Network - Breast)","aka":["SCAN-B","Sweden Cancerome Analysis Network - Breast"],"tldr":"SCAN-B is a Swedish study that reads the genes of almost every new breast cancer diagnosed in the south of the country and follows what happens to the patients. It is not a treatment trial; it is the population cohort that many triple-negative subtype and biomarker findings are checked against.","summary":"SCAN-B (NCT02306096) is a prospective, population-based observational cohort run from Lund University with the South Sweden Breast Cancer Group, enrolling consenting patients with newly diagnosed breast cancer at hospitals across southern Sweden since August 2010, with a registry target of 20,000 participants and primary completion in August 2031. Tumour and blood samples are collected at diagnosis for RNA sequencing and genomic profiling and linked to treatment and outcome data; the registry lists biomarkers with clinicopathological information and invasive disease-free survival as the primary outcomes. For triple-negative breast cancer it is the largest unselected real-world cohort with transcriptomes, used to test how the molecular subtypes, immune signatures and gene-expression classifiers described in trial cohorts behave across a whole population, and to estimate how common each alteration is outside trial populations. It has no interventional arm and reports no treatment effect.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02306096","url":"https://clinicaltrials.gov/study/NCT02306096"},{"label":"SCAN-B project site (Lund University)","url":"https://www.scan-b.lu.se/"}],"tags":["observational"],"related":[],"cancers":["breast-cancer","tnbc","tnbc-early"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["tils"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registered as an observational study; `phase` is set to observational and `enrolled` is the registry's estimated 20,000."],"nct":"NCT02306096","phase":"observational","setting":"Population-based prospective cohort of breast cancer in southern Sweden: RNA sequencing and genomic profiling of every consenting new diagnosis since 2010, with clinical follow-up, 20,000 participants planned to 2031","sponsor":"Lund University, with the South Sweden Breast Cancer Group","started":"2010-08","enrolled":20000,"enrolledBasis":"registry","outcomes":[]},{"id":"scarlet-s2212","kind":"trial","name":"SCARLET (SWOG S2212)","aka":[],"tldr":"Tests whether the anthracycline can be dropped from TNBC pre-surgery treatment without losing effect.","summary":"SCARLET, SWOG trial S2212, NCT05929768, sponsored by SWOG and the NCI, tests whether the anthracycline can be dropped from pre-surgery treatment of stage II to III triple-negative breast cancer without losing effect, comparing an anthracycline-free regimen of carboplatin, docetaxel and pembrolizumab with the KEYNOTE-522 regimen. It is a non-inferiority trial of 2,400 patients with event-free survival as the primary endpoint, and success would reduce cardiotoxicity and leukaemia risk; it is ongoing with no results. OnCo links it to triple-negative breast cancer, pembrolizumab, carboplatin, the TNBC roadmap, the idea of neoadjuvant ADC plus immunotherapy replacing anthracyclines, the SWOG Cancer Research Network and Priyanka Sharma. Whether de-escalation informed by tumour-infiltrating lymphocytes and pembrolizumab can safely retire anthracyclines is the question it will answer.","status":"recruiting","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05929768","url":"https://clinicaltrials.gov/study/NCT05929768"}],"tags":[],"related":[],"cancers":["tnbc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","carboplatin"],"companies":["swog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["priyanka-sharma"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05929768","phase":"3","setting":"Stage II-III TNBC: anthracycline-free carboplatin/docetaxel + pembrolizumab vs KEYNOTE-522 regimen","sponsor":"SWOG / NCI","started":"2023-09-15","startedType":"actual","enrolled":2400,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing; no results."},{"id":"scc-after","kind":"trial","name":"SCC-AFTER","aka":["Adjuvant radiotherapy in patients with high-risk primary cutaneous Squamous Cell Carcinoma AFTER surgery","ISRCTN54806122"],"tldr":"The trial testing a thing the NHS already does without evidence: giving radiotherapy after surgery for a high-risk squamous cell carcinoma, to stop it coming back.","summary":"Adjuvant radiotherapy after excision of a high-risk cutaneous squamous cell carcinoma is widely offered in the UK and has never been tested in a randomised trial. SCC-AFTER, sponsored by Cardiff University with a target of 840 participants and a registered end date of 1 January 2031, is the trial. Together with SPOT-IT and EXCISE it makes Cardiff the centre of British keratinocyte cancer trials, which is itself worth noticing: the commonest cancers in the country have almost no randomised evidence base, and most of what is being built is being built in Wales.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ISRCTN54806122","url":"https://www.isrctn.com/ISRCTN54806122"}],"tags":["uk","skin","radiotherapy","recruiting"],"related":[],"cancers":["cutaneous-scc","skin-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN54806122","phase":"3","setting":"Open-label multicentre two-arm phase 3 randomised trial of adjuvant radiotherapy against no adjuvant radiotherapy after surgery for high-risk primary cutaneous squamous cell carcinoma; registered end date 1 January 2031","sponsor":"Cardiff University","enrolled":840,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04079166","kind":"trial","name":"SCIB1 and iSCIB1+ in Melanoma Patients Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)","aka":["SCOPE"],"tldr":"A phase 2 trial of SCIB1 or iSCIB1+ DNA vaccine in melanoma, run by Scancell Ltd, active and no longer recruiting.","summary":"SCIB1 and iSCIB1+ in Melanoma Patients Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study) is a phase 2 interventional study registered as NCT04079166 by Scancell Ltd, with 173 participants enrolled, started 2019-08-19 and due to reach its primary completion in 2027-01-31. Interventions recorded: SCIB1 or iSCIB1+ DNA vaccine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04079166","url":"https://clinicaltrials.gov/study/NCT04079166"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["scancell"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04079166","phase":"2","setting":"A Phase 2, Multicentre, Open-Label, Umbrella Study of SCIB1 and iSCIB1+ in Patients With Advanced Unresectable Melanoma Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)","sponsor":"Scancell Ltd","started":"2019-08-19","startedType":"actual","enrolled":173,"enrolledBasis":"registry","outcomes":[]},{"id":"scin-trial","kind":"trial","name":"SCIN (curettage then imiquimod against excision for nodular basal cell carcinoma)","aka":["SCIN","Surgery versus Combined treatment with curettage and Imiquimod for Nodular basal cell carcinoma"],"tldr":"Scraping the lump off first and then using the cream was tested against simply cutting it out, for the thicker kind of basal cell carcinoma. It did not come close: about one in five of those treated without surgery had the tumour back within five years, against one in fifty after the operation.","summary":"The creams are licensed for the thin superficial form of basal cell carcinoma. SCIN asked whether they could be stretched to the commoner nodular form by scraping the visible tumour away first, on the reasoning that curettage removes the bulk and the cream deals with what is left. Two Dutch dermatology departments randomised 145 patients with a primary nodular basal cell carcinoma of 4 to 20 mm between January 2016 and November 2017, 73 to superficial curettage followed by imiquimod and 72 to surgical excision. Follow-up finished in September 2022.\n\nFifteen treatment failures occurred in the curettage and imiquimod group, five of them between one and five years, against one in the surgery group. The probability of remaining free from treatment failure at five years was 77.8 per cent after curettage and imiquimod (95 per cent confidence interval 65.7 to 86.0) against 98.2 per cent after excision (88.0 to 99.8). The relative risk of treatment failure was 15.93 (2.10 to 120.64), and its confidence interval does not exclude the pre-specified non-inferiority margin of 5.22, so non-inferiority could not be concluded. Twenty patients died of causes unrelated to the skin cancer during follow-up; accounting for that as a competing risk gave a subhazard ratio of 16.16 (2.18 to 119.72).\n\nThe authors' own reading is worth keeping, because it is the honest version of a negative trial: most failures happened in the first year, and a person who is still clear a year after curettage and imiquimod has a 77.8 per cent chance of staying clear at five. That is a real option for someone who cannot or will not have an operation on the face. It is not equivalence.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02242929","url":"https://clinicaltrials.gov/study/NCT02242929"},{"label":"Five-year results (JAMA Dermatology 2025)","url":"https://doi.org/10.1001/jamadermatol.2024.5572"},{"label":"Five-year results on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/39878970/"}],"tags":[],"related":[],"cancers":["basal-cell-carcinoma","skin-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["imiquimod"],"companies":[],"institutions":[],"pathways":[],"terms":["topical-and-destructive-treatment-bcc","curettage-and-cautery"],"trials":["sins-trial","mal-pdt-imiquimod-fluorouracil-superficial-bcc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02242929","phase":"3","setting":"Primary nodular basal cell carcinoma of 4 to 20 mm: superficial curettage followed by imiquimod 5 per cent cream against surgical excision, with freedom from treatment failure at one year as the primary outcome and at five years as a pre-specified secondary outcome","sponsor":"Maastricht University Medical Centre","result":"Freedom from treatment failure at five years 77.8 per cent after curettage with imiquimod against 98.2 per cent after surgical excision; relative risk of failure 15.93 (95 per cent confidence interval 2.10 to 120.64), non-inferiority not concluded.","started":"2016-01","startedType":"actual","yearReported":2025,"enrolled":145,"enrolledBasis":"registry","outcomes":[{"endpoint":"Free from treatment failure at 5 years","primary":true,"unit":"%","arms":[{"name":"Superficial curettage then imiquimod","n":73,"value":77.8,"note":"95 per cent confidence interval 65.7 to 86.0; 15 failures"},{"name":"Surgical excision","n":72,"value":98.2,"note":"95 per cent confidence interval 88.0 to 99.8; 1 failure"}],"source":"https://doi.org/10.1001/jamadermatol.2024.5572"}],"replication":"Consistent with SINS, where imiquimod given for twelve weeks for nodular disease without curettage was also inferior to excision."},{"id":"scot","kind":"trial","name":"SCOT","aka":["Short Course Oncology Therapy","ISRCTN59757862"],"tldr":"The Glasgow-led trial that halved the length of chemotherapy after bowel cancer surgery, sparing thousands of people lasting nerve damage.","summary":"SCOT randomised 6,088 people with high-risk stage II or stage III colorectal cancer to three or six months of oxaliplatin-containing adjuvant chemotherapy. Three-year disease-free survival was 76.7 percent with three months and 77.1 percent with six, a hazard ratio of 1.006 (0.909 to 1.114), comfortably inside the non-inferiority margin. Peripheral neuropathy of grade 2 or worse was far more common after six months (58 percent against 25 percent in the safety subset), was long-lasting and was associated with worse quality of life. Three months is now the usual offer in NICE NG151, which recommends CAPOX for three months first for stage 3 colon and rectal cancer.","status":"positive","asOf":"2026-09-24","links":[{"label":"Lancet Oncology 2018","url":"https://europepmc.org/article/MED/29611518"},{"label":"ISRCTN59757862","url":"https://www.isrctn.com/ISRCTN59757862"}],"tags":["uk","adjuvant","colorectal","de-escalation"],"related":[],"cancers":["colorectal","colon-cancer"],"sections":["chemotherapy"],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["capox","folfox","oxaliplatin","capecitabine"],"companies":[],"institutions":["beatson-glasgow","oxford-cancer"],"pathways":[],"terms":["neoadjuvant-adjuvant","de-escalation"],"trials":["idea-collaboration"],"people":["rachel-kerr"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN59757862","phase":"3","setting":"Three months against six months of adjuvant oxaliplatin with a fluoropyrimidine (CAPOX or FOLFOX) after resection of high-risk stage II or stage III colorectal cancer; 244 centres, non-inferiority design with a hazard ratio margin of 1.13","sponsor":"NHS Greater Glasgow and Clyde with the University of Glasgow","result":"Three-year disease-free survival 76.7 percent with three months against 77.1 percent with six (hazard ratio 1.006, 0.909 to 1.114, non-inferiority p = 0.012), with grade 2 or worse peripheral neuropathy in 25 percent against 58 percent.","yearReported":2018,"enrolled":6088,"enrolledBasis":"randomised","enrolledNote":"6,088 people were randomised between 27 March 2008 and 29 November 2013; 6,065 consented to their data being used.","outcomes":[{"endpoint":"Disease-free survival at 3 years","primary":true,"unit":"percent","arms":[{"name":"3 months","n":3035,"value":76.7},{"name":"6 months","n":3030,"value":77.1}],"hr":1.006,"ci":[0.909,1.114],"p":"0.012 for non-inferiority","source":"https://europepmc.org/article/MED/29611518"}]},{"id":"screentrustcad","kind":"trial","name":"ScreenTrustCAD","aka":["ScreenTrust CAD","STGKS001"],"tldr":"In Stockholm's screening programme, replacing one of the two radiologists with Lunit's mammography software found at least as many breast cancers as two radiologists reading together, the first prospective evidence that this software can take over one reader's seat.","summary":"ScreenTrustCAD (NCT04778670; organisation id STGKS001) was a prospective, population-based, paired-reader, non-inferiority study at Capio Sankt Göran Hospital in Stockholm, sponsored by Karolinska University Hospital with Lunit as a collaborator and part funder. Consecutive women aged 40 to 74 without breast implants attending population screening in the hospital's catchment were included. Every examination was read independently by two radiologists and by Lunit INSIGHT MMG. The primary outcome was screen-detected breast cancer within three months of mammography, and the primary analysis tested whether double reading by one radiologist plus AI was non-inferior (margin 0.15 relative reduction in cancer diagnoses) to standard double reading by two radiologists; AI alone and triple reading by two radiologists plus AI were also compared.\n\nFrom 1 April 2021 to 9 June 2022, 58,344 women were screened and 55,581 were included. Screen-detected cancer followed an initial positive read in 269 women (0.5 percent). One radiologist plus AI detected 261 cancers (0.5 percent) against 250 (0.4 percent) for two radiologists (relative proportion 1.04, 95 percent CI 1.00 to 1.09), meeting non-inferiority. AI alone detected 246 (relative proportion 0.98, 0.93 to 1.04) and two radiologists plus AI detected 269 (1.08, 1.04 to 1.11), both also non-inferior. The authors conclude that replacing one radiologist with AI gave a 4 percent higher, non-inferior detection rate and that the software has potential for controlled implementation with risk management and real-world follow-up.\n\nThe registry lists the study as interventional with no drug phase, which is why the phase 2 and 3 pass never attached it. MASAI, the Swedish randomised trial of AI-supported screening, used Transpara and is a separate record.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04778670","url":"https://clinicaltrials.gov/study/NCT04778670"},{"label":"Lancet Digital Health 2023","url":"https://doi.org/10.1016/S2589-7500(23)00153-X"}],"tags":[],"related":[],"cancers":["breast-hr-positive","tnbc"],"sections":[],"technologies":["mammography","radiology-ai-screening"],"targets":[],"drugs":["lunit-insight-mmg"],"companies":["lunit"],"institutions":["karolinska"],"pathways":[],"terms":["screening"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-screentrustcad-dembrower-lancet-digit-health-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04778670","phase":"observational","setting":"Population mammography screening at Capio Sankt Göran Hospital, Stockholm: paired-reader non-inferiority comparison of one radiologist plus Lunit INSIGHT MMG against standard double reading by two radiologists, with AI alone and two radiologists plus AI as further comparisons","sponsor":"Karolinska University Hospital","result":"One radiologist plus AI detected 261 screen-detected cancers vs 250 for two radiologists (relative proportion 1.04, 95% CI 1.00 to 1.09), meeting non-inferiority; AI alone 246 and two radiologists plus AI 269 were also non-inferior.","started":"2021-04-01","startedType":"actual","yearReported":2023,"enrolled":55581,"enrolledBasis":"analysed","enrolledNote":"The Lancet Digital Health 2023 report includes 55,581 of the 58,344 women screened between April 2021 and June 2022; ClinicalTrials.gov NCT04778670 lists an actual enrolment of 55,579.","outcomes":[{"endpoint":"Screen-detected breast cancers (primary comparison: one radiologist plus AI versus two radiologists)","primary":true,"unit":"cases","arms":[{"name":"One radiologist + Lunit INSIGHT MMG","n":55581,"value":261,"note":"0.5%; relative proportion 1.04 (95% CI 1.00 to 1.09) vs two radiologists; non-inferiority margin 0.15 relative reduction"},{"name":"Two radiologists (standard double reading)","n":55581,"value":250,"note":"0.4%"}],"source":"https://doi.org/10.1016/S2589-7500(23)00153-X"},{"endpoint":"Screen-detected breast cancers, AI alone versus two radiologists","unit":"cases","arms":[{"name":"Lunit INSIGHT MMG alone","n":55581,"value":246,"note":"Relative proportion 0.98 (95% CI 0.93 to 1.04); non-inferior"},{"name":"Two radiologists (standard double reading)","n":55581,"value":250}],"source":"https://doi.org/10.1016/S2589-7500(23)00153-X"},{"endpoint":"Screen-detected breast cancers, two radiologists plus AI versus two radiologists","unit":"cases","arms":[{"name":"Two radiologists + Lunit INSIGHT MMG","n":55581,"value":269,"note":"Relative proportion 1.08 (95% CI 1.04 to 1.11)"},{"name":"Two radiologists (standard double reading)","n":55581,"value":250}],"source":"https://doi.org/10.1016/S2589-7500(23)00153-X"}],"replication":"MASAI (NCT04838756; Transpara) is the randomised Swedish trial of AI-supported screening and reached a similar conclusion with a different product; a Radiology 2025 secondary analysis of ScreenTrustCAD examined recall and positive predictive value by reader and is not used for outcome values here."},{"id":"nct07549399","kind":"trial","name":"SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC","aka":["CRITII"],"tldr":"A phase 3 trial of cetuximab and bevacizumab (glioblastoma use) in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC is a phase 3, randomised interventional study registered as NCT07549399 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 204 participants, started 2026-05-20 and due to reach its primary completion in 2029-04-30. Interventions recorded: Short-Course Radiotherapy; PD-1 monoclonal antibody; mFOLFOX6 regimen; Cetuximab; Bevacizumab; Surgical resection. Conditions listed: Rectal Adenocarcinoma; High-Risk Cancer; MSS. Primary outcome: 3 years DFS Rate. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed pMMR/MSS rectal adenocarcinoma; all other histological types are excluded\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07549399","url":"https://clinicaltrials.gov/study/NCT07549399"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt","monoclonal-antibody"],"targets":[],"drugs":["cetuximab","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07549399","phase":"3","setting":"Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS/BRAF Wild-Type)/Bevacizumab (for RAS/BRAF Mutant) in High-Risk pMMR/MSS Rectal Adenocarcinoma: a Phase III Randomized Controlled Trial","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2026-05-20","startedType":"actual","enrolled":204,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07551479","kind":"trial","name":"SCRT Based iTNT vs. LCRT Based TNT for MSS Locally Advanced Rectal Cancer","aka":["TORCH-STAR"],"tldr":"A phase 3 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"SCRT Based iTNT vs. LCRT Based TNT for MSS Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT07551479 by Fudan University, with a registry enrolment figure of 612 participants, started 2026-05-01 and due to reach its primary completion in 2032-12-31. Interventions recorded: short-course radiaotherapy; long-course chemoradiaothearpy; Capecitabine; Oxaliplatin; PD-1 inhibitor. Conditions listed: Locally Advanced Rectal Cancer (LARC); MSS (Microsatellite Stable). Primary outcome: 3 year event-free survival rate. Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07551479","url":"https://clinicaltrials.gov/study/NCT07551479"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07551479","phase":"3","setting":"SCRT Followed by CAPOX and PD-1 Inhibitor Versus LCCRT Followed by CAPOX in Total Neoadjuvant Treatment for High-risk LARC: A Prospective, Randomized, Multicenter, Phase III Study","sponsor":"Fudan University","started":"2026-05-01","startedType":"estimated","enrolled":612,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07837362","kind":"trial","name":"SCRT Combined With CAPOX and PD-1/CTLA4 Antibody for Early-stage Low Rectal Cancer","aka":[],"tldr":"A phase 2 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"SCRT Combined With CAPOX and PD-1/CTLA4 Antibody for Early-stage Low Rectal Cancer is a phase 2, interventional study registered as NCT07837362 by Fudan University, with a registry enrolment figure of 34 participants, started 2026-09-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: Shor-course radiotherapy; PD-1/CTLA4 Antibody; Capecitabine; Oxaliplatin. Conditions listed: Early Low Rectal Cancer. Primary outcome: complete response (CR) rate. Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07837362","url":"https://clinicaltrials.gov/study/NCT07837362"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07837362","phase":"2","setting":"The Combination of PD-1/CTLA4 Antibody and Neoadjuvant Short-course Radiotherapy in Early-stage Low Rectal Cancer","sponsor":"Fudan University","started":"2026-09-01","startedType":"estimated","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06864013","kind":"trial","name":"SCRT Combined With Chemotherapy and Iparomlimab and Tuvonralimab in MSS or pMMR Patients With Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by First Affiliated Hospital of Zhejiang University, now recruiting.","summary":"SCRT Combined With Chemotherapy and Iparomlimab and Tuvonralimab in MSS or pMMR Patients With Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT06864013 by First Affiliated Hospital of Zhejiang University, with a registry enrolment figure of 116 participants, started 2025-01-06 and due to reach its primary completion in 2029-12-31. Interventions recorded: Experimental; Control. Conditions listed: Locally Advanced Rectal Cancer (LARC). Primary outcome: Complete Response; Clinical Complete Response; Pathologic Complete Response. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06864013","url":"https://clinicaltrials.gov/study/NCT06864013"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06864013","phase":"2","setting":"Short-course Neoadjuvant Radiotherapy Combined With Chemotherapy and Iparomlimab and Tuvonralimab in Microsatellite Stability (MSS) or Mismatch-repair-proficient (pMMR) Patients With Locally Advanced Rectal Cancer: A Randomized Controlled Clinical Study","sponsor":"First Affiliated Hospital of Zhejiang University","started":"2025-01-06","startedType":"actual","enrolled":116,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07162714","kind":"trial","name":"SCRT Followed by AK112 in pMMR/MSS Mid-low Rectal Cancer","aka":["STAR"],"tldr":"A phase 2 trial of ivonescimab in colorectal cancer, run by Zhejiang Cancer Hospital, now recruiting.","summary":"SCRT Followed by AK112 in pMMR/MSS Mid-low Rectal Cancer is a phase 2, interventional study registered as NCT07162714 by Zhejiang Cancer Hospital, with a registry enrolment figure of 30 participants, started 2025-10-27 and due to reach its primary completion in 2027-03-31. Interventions recorded: radiotherapy; Ivonescimab (20mg/kg Q3W); Non-operative Management; Surgery. Conditions listed: Rectal Cancer; Radiation; AK112. Primary outcome: Complete remission rate (CR rate). Colorectal eligibility wording from the registry: \"Histopathologically confirmed rectal adenocarcinoma, without any prior anti - tumor treatment; The status of MMR/MSI is detected by IHC/PCR in pathological biopsy to clarify that the patient's classification is pMMR/MSS;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07162714","url":"https://clinicaltrials.gov/study/NCT07162714"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["ivonescimab"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07162714","phase":"2","setting":"Short-Course Radiotherapy Followed by Ivonescimab (AK112) in pMMR/MSS Mid-Low Rectal Cancer: An Exploratory Phase II Clinical Study.","sponsor":"Zhejiang Cancer Hospital","started":"2025-10-27","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07198165","kind":"trial","name":"SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Ruijin Hospital, now recruiting.","summary":"SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC is a phase 2, randomised interventional study registered as NCT07198165 by Ruijin Hospital, with a registry enrolment figure of 104 participants, started 2025-09-05 and due to reach its primary completion in 2030-12-31. Interventions recorded: PD-1 inhibitor based immunotherapy. Conditions listed: Rectal Cancer; Rectal Adenocarcinoma; Rectal Cancer, Radiotherapy; Rectal Cancer Patients; Immunotherapy; Total Neoadjuvant Therapy; Total Neoadjuvant Treatment; Targeted Therapy; Chemoradiotherapy. Primary outcome: Complete Response rate. Colorectal eligibility wording from the registry: \"* Histopathologically confirmed rectal adenocarcinoma with no prior antitumor therapy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07198165","url":"https://clinicaltrials.gov/study/NCT07198165"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07198165","phase":"2","setting":"Short-Course Radiotherapy Combined With CAPOX and Bevacizumab, With or Without PD-1 Inhibitors, as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer","sponsor":"Ruijin Hospital","started":"2025-09-05","startedType":"actual","enrolled":104,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05576480","kind":"trial","name":"SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer","aka":["SPARC"],"tldr":"A phase 2 trial of penpulimab and cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Ruijin Hospital, now recruiting.","summary":"SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT05576480 by Ruijin Hospital, with a registry enrolment figure of 55 participants, started 2023-02-06 and due to reach its primary completion in 2025-10. Interventions recorded: Short-course radiotherapy; Penpulimab; CAPEOX; TME surgery. Conditions listed: Rectal Cancer; Locally Advanced. Primary outcome: Pathological complete remission rate (pCR). Colorectal eligibility wording from the registry: \"* Patients with pathologically confirmed rectal adenocarcinoma, assessed by MRI as mid-low rectal cancer (the lower border of the tumor is less than 10cm from the anal verge), clinical stage II-III (cT1-2N1-2M0 or T3-4N0-2M0) according to the 8th Edition of AJCC Cancer Staging Manual\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05576480","url":"https://clinicaltrials.gov/study/NCT05576480"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["penpulimab","capox"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05576480","phase":"2","setting":"Efficacy and Safety of Short-course Radiotherapy Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of Microsatellite Stable Locally Advanced Rectal Cancer: a Single-centre, Single-arm, Phase 2 Study","sponsor":"Ruijin Hospital","started":"2023-02-06","startedType":"actual","enrolled":55,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07284992","kind":"trial","name":"SCRT VS LCRT Followed by PD-L1 Inhibitor Plus CAPEOX as TNT in Patients With LARC","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Shandong Provincial Hospital, now recruiting.","summary":"SCRT VS LCRT Followed by PD-L1 Inhibitor Plus CAPEOX as TNT in Patients With LARC is a phase 2, randomised interventional study registered as NCT07284992 by Shandong Provincial Hospital, with a registry enrolment figure of 208 participants, started 2025-09-12 and due to reach its primary completion in 2028-11-30. Interventions recorded: short-term radiotherapy combined with Adebrelimab and capox; long-term radiotherapy combined with Adebrelimab and capox. Conditions listed: Rectal Cancer; Advanced Stage Colorectal Cancer; Radiotherapy. Primary outcome: CR rate. Colorectal eligibility wording from the registry: \"Patients diagnosed as rectal adenocarcinoma by primary biopsy and histopathological examination;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07284992","url":"https://clinicaltrials.gov/study/NCT07284992"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07284992","phase":"2","setting":"Total Neoadjuvant Treatment With Short-course Radiotherapy Versus Long-course Radiotherapy Followed by PD-L1 Inhibitor Plus Capecitabine-Oxaliplatin in Patients With Locally Advanced Rectal Cancer: a Multi-centres, Open-label, Phase 2, Randomized Controlled Trial","sponsor":"Shandong Provincial Hospital","started":"2025-09-12","startedType":"actual","enrolled":208,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06850103","kind":"trial","name":"SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases","aka":[],"tldr":"A phase 2 trial of serplulimab in colorectal cancer, run by First Affiliated Hospital of Zhejiang University, now recruiting.","summary":"SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases is a phase 2, interventional study registered as NCT06850103 by First Affiliated Hospital of Zhejiang University, with a registry enrolment figure of 51 participants, started 2025-04-22 and due to reach its primary completion in 2027-12-31. Interventions recorded: short-course radiotherapy; CAPEOX/XELOX; Serplulimab; surgery. Conditions listed: Colorectal Carcinoma; Oligometastases; pMMR; MSS; iTNT. Primary outcome: 3-year PFS. Colorectal eligibility wording from the registry: \"Histologically confirmed primary rectal adenocarcinoma, with MRI showing tumor location within 10cm from the anal verge\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06850103","url":"https://clinicaltrials.gov/study/NCT06850103"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06850103","phase":"2","setting":"A Phase II Exploratory Multicenter Randomized Controlled Clinical Trial to Evaluate the Effectiveness of Neoadjuvant Short-Course Radiotherapy (SCRT) Followed by CAPEOX Chemotherapy and Serplulimab in Microsatellite Stable (MSS) or Proficient Mismatch Repair (pMMR) Rectal Cancer With Synchronous Oligometastases","sponsor":"First Affiliated Hospital of Zhejiang University","started":"2025-04-22","startedType":"actual","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06787183","kind":"trial","name":"SCRT(Short Course Radiotherapy) Combined With CAPOX Plus QL1706 for Rectal Cancer Liver Metastases","aka":[],"tldr":"A phase 2 trial of capecitabine, fOLFOX (5-FU, leucovorin, oxaliplatin) and QL1706 in colorectal cancer, run by Fujian Cancer Hospital, now recruiting.","summary":"SCRT(Short Course Radiotherapy) Combined With CAPOX Plus QL1706 for Rectal Cancer Liver Metastases is a phase 2, interventional study registered as NCT06787183 by Fujian Cancer Hospital, with a registry enrolment figure of 42 participants, started 2025-12-01 and due to reach its primary completion in 2026-12-01. Interventions recorded: Short course radiotherapy; Capecitabine; Oxaliplatin; QL1706. Conditions listed: Locally Advanced Rectal Cancer With Liver Metastases. Primary outcome: Progression-free-Survival. Colorectal eligibility wording from the registry: \"Pathologically confirmed rectal cancer with liver metastases (stage M1)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06787183","url":"https://clinicaltrials.gov/study/NCT06787183"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capecitabine","folfox","ql1706"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06787183","phase":"2","setting":"A Phase II Multicenter Clinical Trail of Efficacy and Safety of Short Course Radiotherapy Combined With CAPOX and PD-1/CTLA-4 Bispecific Antibody QL1706 in Patients With Liver Metastases From Rectal Cancer","sponsor":"Fujian Cancer Hospital","started":"2025-12-01","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07662395","kind":"trial","name":"SCTB41 Combined With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2/3 trial testing SCTB41 in non-small-cell lung cancer, now recruiting.","summary":"SCTB41 Combined With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer is a phase 2/3 interventional study registered as NCT07662395, led by Sinocelltech, and recruiting on the registry. Official title: A Multicenter Phase II/III Study Evaluating the Efficacy and Safety of SCTB41 Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Driver-Negative Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC). Planned enrolment is 410 participants (estimated). The study started in 2026-05-09 and primary completion is expected in 2030-01-24. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07662395","url":"https://clinicaltrials.gov/study/NCT07662395"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["sctb41"],"companies":["sinocelltech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07662395","phase":"2/3","setting":"A Multicenter Phase II/III Study Evaluating the Efficacy and Safety of SCTB41 Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Driver-Negative Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Sinocelltech","started":"2026-05-09","startedType":"actual","enrolled":410,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03413254","kind":"trial","name":"Second and Third Look Laparoscopy in pT4 Colon Cancer Patients for Early Detection of Peritoneal Metastases","aka":["COLOPEC-II"],"tldr":"A phase 3 trial in colorectal cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), active but no longer recruiting.","summary":"Second and Third Look Laparoscopy in pT4 Colon Cancer Patients for Early Detection of Peritoneal Metastases is a phase 3, randomised interventional study registered as NCT03413254 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), with a registry enrolment figure of 389 participants, started 2018-03-01 and due to reach its primary completion in 2025-03-01. Interventions recorded: Routine follow-up; Second look DLS; Third look DLS. Conditions listed: Colorectal Cancer; Peritoneal Metastases. Primary outcome: Proportion of peritoneal metastases detected after a negative second look DLS. Colorectal eligibility wording from the registry: \"* Curative intent resection of pT4a,bN0-2M0 colon cancer or rectosigmoid cancer above the peritoneal reflection, with or without adjuvant systemic therapy;\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03413254","url":"https://clinicaltrials.gov/study/NCT03413254"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["robotic-surgery"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03413254","phase":"3","setting":"Second and Third Look Laparoscopy in pT4 Colon Cancer Patients for Early Detection of Peritoneal Metastases; the COLOPEC-II Randomized Multicentre Trial","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","started":"2018-03-01","startedType":"actual","enrolled":389,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07150403","kind":"trial","name":"Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal","aka":[],"tldr":"A phase 2 trial of leucovorin (folinic acid), fOLFIRI (5-FU, leucovorin, irinotecan), fruquintinib and bevacizumab (glioblastoma use) in colorectal cancer, run by Federation Francophone de Cancerologie Digestive, not yet recruiting.","summary":"Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07150403 by Federation Francophone de Cancerologie Digestive, with a registry enrolment figure of 74 participants, started 2025-12-31 and due to reach its primary completion in 2028-02-28. Interventions recorded: Oxaliplatin intravenous; 5 FU bolus; Folinic acid; 5 FU continuous; Irinotecan; FRUQUINTINIB; BEVACIZUMAB. Conditions listed: Metastatic Colorectal Carcinoma (mCRC). Primary outcome: Disease Control Rate (DCR). Colorectal eligibility wording from the registry: \"* Patients with a histologically confirmed diagnosis of metastatic colorectal cancer (mCRC), with a documented disease progression (as per RECIST v1\". Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07150403","url":"https://clinicaltrials.gov/study/NCT07150403"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","kinase-inhibitors","topoisomerase-inhibitors"],"targets":[],"drugs":["leucovorin","folfiri","fruquintinib","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07150403","phase":"2","setting":"A Phase II, Open-label, Non-comparative, Randomized Study of Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer","sponsor":"Federation Francophone de Cancerologie Digestive","started":"2025-12-31","startedType":"estimated","enrolled":74,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06700603","kind":"trial","name":"Second-line Irinotecan Liposome Combination Regimen for Irinotecan-treated Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of fluorouracil (5-FU) in pancreatic cancer, run by Rui-hua Xu, MD, PhD, not yet recruiting.","summary":"Second-line Irinotecan Liposome Combination Regimen for Irinotecan-treated Pancreatic Cancer is a phase 2, interventional study registered as NCT06700603 by Rui-hua Xu, MD, PhD, with a registry enrolment figure of 48 participants, started 2024-11-20 and due to reach its primary completion in 2025-12-31. Interventions recorded: Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate. Conditions listed: Pancreatic Cancer. Primary outcome: (PFS). Pancreatic eligibility wording from the registry: \"histologically or cytologically confirmed as pancreatic ductal adenocarcinoma;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06700603","url":"https://clinicaltrials.gov/study/NCT06700603"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06700603","phase":"2","setting":"Phase II Clinical Study of Irinotecan Liposome Combined with 5-FU/LV for the Patients with Advanced Pancreatic Cancer Who Failed to Receive Irinotecan-containing Regimens","sponsor":"Rui-hua Xu, MD, PhD","started":"2024-11-20","startedType":"estimated","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06856187","kind":"trial","name":"Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer","aka":["TASBEL"],"tldr":"A phase 2 trial of trifluridine/tipiracil and bevacizumab (glioblastoma use) in colorectal cancer, run by Fudan University, now recruiting.","summary":"Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer is a phase 2, randomised interventional study registered as NCT06856187 by Fudan University, with a registry enrolment figure of 119 participants, started 2025-02-28 and due to reach its primary completion in 2026-06-30. Interventions recorded: TAS-102+bevacizumab+local treatment; Standard chemotherapy. Conditions listed: Metastatic Colorectal Cancer (CRC). Primary outcome: Time to treatment failure (TTF). Colorectal eligibility wording from the registry: \"* Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06856187","url":"https://clinicaltrials.gov/study/NCT06856187"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["trifluridine-tipiracil","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06856187","phase":"2","setting":"A Randomized, Phase II Clinical Study of Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer","sponsor":"Fudan University","started":"2025-02-28","startedType":"actual","enrolled":119,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06242067","kind":"trial","name":"Second-line Treatment of Metastatic Colorectal Cancer","aka":["BEV-TASIRI"],"tldr":"A phase 2 trial of trifluridine/tipiracil in colorectal cancer, run by Qilu Hospital of Shandong University, now recruiting.","summary":"Second-line Treatment of Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06242067 by Qilu Hospital of Shandong University, with a registry enrolment figure of 50 participants, started 2023-04-23 and due to reach its primary completion in 2024-12. Interventions recorded: Trifluridine/tipiracil. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: progression-free survival(PFS). Colorectal eligibility wording from the registry: \"Histologically or cytological proven metastatic or recurrent adenocarcinoma of the colon or rectum\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06242067","url":"https://clinicaltrials.gov/study/NCT06242067"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["trifluridine-tipiracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06242067","phase":"2","setting":"Irinotecan in Combination With Trifluridine-tipiracil and Bevacizumab in Pre-treated Metastatic Colorectal Cancer","sponsor":"Qilu Hospital of Shandong University","started":"2023-04-23","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06166589","kind":"trial","name":"Second-line Zimberelimab and SIRIOX Chemotherapy for Patient With Previously AG Chemotherapy Treated Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of zimberelimab, cAPOX (capecitabine, oxaliplatin), tegafur, gimeracil and oteracil (S-1) and fOLFIRI (5-FU, leucovorin, irinotecan) in pancreatic cancer, run by Shanghai Zhongshan Hospital, not yet recruiting.","summary":"Second-line Zimberelimab and SIRIOX Chemotherapy for Patient With Previously AG Chemotherapy Treated Pancreatic Cancer is a phase 2, interventional study registered as NCT06166589 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 19 participants, started 2024-01-01 and due to reach its primary completion in 2026-01-01. Interventions recorded: Zimberelimab; Oxaliplatin; S-1; Irinotecan. Conditions listed: Previously AG Chemotherapy Treated Pancreatic Cancer. Primary outcome: ORR. Pancreatic eligibility wording from the registry: \"* Patients with pancreatic cancer progressing after first-line AG regimen chemotherapy, including patients with advanced pancreatic cancer progressing after first-line AG regimen chemotherapy and patients with recurrence and metastasis after radical pancreatic cancer surgery assisted by AG regimen c\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06166589","url":"https://clinicaltrials.gov/study/NCT06166589"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["zimberelimab","capox","tegafur-gimeracil-oteracil","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06166589","phase":"2","setting":"The Efficacy and Safety of Second-line Zimberelimab and SIRIOX Chemotherapy for Patient With Previously AG Chemotherapy Treated Pancreatic Cancer: A Prospective, Single Arm, Phase II Clinical Study","sponsor":"Shanghai Zhongshan Hospital","started":"2024-01-01","startedType":"estimated","enrolled":19,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05717803","kind":"trial","name":"Segmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012)","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Fudan University, now recruiting.","summary":"Segmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012) is a phase 3, interventional study registered as NCT05717803 by Fudan University, with a registry enrolment figure of 307 participants, started 2023-02-15 and due to reach its primary completion in 2028-12-31. Interventions recorded: Segmentectomy. Conditions listed: Segmentectomy; Lung Adenocarcinoma. Primary outcome: 5-year disease-free survival. Lung eligibility wording from the registry: \"* Not receiving lung cancer surgery before;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05717803","url":"https://clinicaltrials.gov/study/NCT05717803"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05717803","phase":"3","setting":"Segmentectomy for Ground Glass-dominant Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial","sponsor":"Fudan University","started":"2023-02-15","startedType":"actual","enrolled":307,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06634966","kind":"trial","name":"Segmentectomy for Solid-dominant Lung Cancer","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Fudan University, now recruiting.","summary":"Segmentectomy for Solid-dominant Lung Cancer is a phase 3, interventional study registered as NCT06634966 by Fudan University, with a registry enrolment figure of 277 participants, started 2024-07-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: Segmentectomy. Conditions listed: Segmentectomy; Lung Adenocarcinoma. Primary outcome: 5-year disease-free survival. Lung eligibility wording from the registry: \"* Not receiving lung cancer surgery before;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06634966","url":"https://clinicaltrials.gov/study/NCT06634966"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06634966","phase":"3","setting":"Segmentectomy for Solid-dominant GGO-featured Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial","sponsor":"Fudan University","started":"2024-07-01","startedType":"actual","enrolled":277,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07169903","kind":"trial","name":"Segmentectomy vs Lobectomy for 2 - 3cm IASLC Grade 1-2 Lung Adenocarcinoma: A Multi-center RCT","aka":["STAR012"],"tldr":"A phase 3 trial in lung cancer, run by Shanghai Pulmonary Hospital, Shanghai, China, not yet recruiting.","summary":"Segmentectomy vs Lobectomy for 2 - 3cm IASLC Grade 1-2 Lung Adenocarcinoma: A Multi-center RCT is a phase 3, randomised interventional study registered as NCT07169903 by Shanghai Pulmonary Hospital, Shanghai, China, with a registry enrolment figure of 587 participants, started 2025-10-01 and due to reach its primary completion in 2033-03-31. Interventions recorded: Pulmonary segmentectomy. Conditions listed: Lung Adenocarcinoma. Primary outcome: Overall Survival (OS); Recurrence-Free Survival (RFS). Lung eligibility wording from the registry: \"* Suspicion of non-small cell lung cancer (NSCLC)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07169903","url":"https://clinicaltrials.gov/study/NCT07169903"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07169903","phase":"3","setting":"Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma 2 - 3cm With IASLC Grade 1 - 2 by Intraoperative Frozen Sections: A Prospective and Multi - Center Randomized Controlled Trial Study","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","started":"2025-10-01","startedType":"estimated","enrolled":587,"enrolledBasis":"registry","outcomes":[]},{"id":"select-lenvatinib","kind":"trial","name":"SELECT","aka":[],"tldr":"Turned lenvatinib into the main drug for thyroid cancers that no longer take up radioactive iodine, quadrupling the time before the disease grew.","summary":"SELECT, trial NCT01321554 sponsored by Eisai and reported in 2015, turned lenvatinib into the main drug for differentiated thyroid cancers that no longer take up radioactive iodine, quadrupling the time before the disease grew. It randomised 392 patients with progressive radioiodine-refractory disease to lenvatinib or placebo, met its primary progression-free survival endpoint with a very large effect and a response rate near two-thirds against almost none on placebo, leading to FDA approval in February 2015; hypertension in about two-thirds and dose reductions in more than sixty percent drive management, and survival was confounded by crossover. OnCo links it to thyroid cancer, kinase inhibitors and anti-angiogenic therapy, VEGF and RET as targets, the radioiodine-refractory term and Martin Schlumberger. When to start a drug this toxic in a slow disease is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01321554","url":"https://clinicaltrials.gov/study/NCT01321554"},{"label":"NEJM 2015","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1406470"}],"tags":[],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["kinase-inhibitors","antiangiogenic"],"targets":["vegf","ret"],"drugs":[],"companies":["eisai"],"institutions":[],"pathways":[],"terms":["rai-refractory"],"trials":[],"people":["martin-schlumberger"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01321554","phase":"3","setting":"Radioiodine-refractory differentiated thyroid cancer with progression: lenvatinib vs placebo","sponsor":"Eisai","result":"PFS 18.3 vs 3.6 months; HR 0.21.","started":"2011-03-17","startedType":"actual","yearReported":2015,"enrolled":392,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Lenvatinib","value":18.3},{"name":"Placebo","value":3.6}],"hr":0.21,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1406470"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Lenvatinib","value":64.8},{"name":"Placebo","value":1.5}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1406470"}],"replication":"DECISION (sorafenib) showed the same direction with a smaller effect; class effect of VEGFR multikinase inhibitors is established."},{"id":"nct06031246","kind":"trial","name":"Selective Lymph Node Dissection for cT1N0M0 Invasive NSCLC With CTR>0.5 Located in the Apical Segment (ECTOP-1018)","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Fudan University, now recruiting.","summary":"Selective Lymph Node Dissection for cT1N0M0 Invasive NSCLC With CTR>0.5 Located in the Apical Segment (ECTOP-1018) is a phase 3, interventional study registered as NCT06031246 by Fudan University, with a registry enrolment figure of 634 participants, started 2023-04-01 and due to reach its primary completion in 2026-01-01. Interventions recorded: Selective Lymph Node Dissection. Conditions listed: Lung Adenocarcinoma; Lymph Node Metastasis. Primary outcome: 5-year overall survival. Lung eligibility wording from the registry: \"Not receiving lung cancer surgery before;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06031246","url":"https://clinicaltrials.gov/study/NCT06031246"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-adenocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06031246","phase":"3","setting":"Selective Lymph Node Dissection for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR>0.5 Located in the Apical Segment: a Single-arm, Multi-center, Phase III Trial","sponsor":"Fudan University","started":"2023-04-01","startedType":"actual","enrolled":634,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07617389","kind":"trial","name":"Selective Mediastinal Lymph Node Sampling Versus Systematic medIastinal Lymph Node Dissection After Neoadjuvant Chemoimmunotherapy for Non-small Cell Lung Cance","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Wen-zhao ZHONG, not yet recruiting.","summary":"Selective Mediastinal Lymph Node Sampling Versus Systematic medIastinal Lymph Node Dissection After Neoadjuvant Chemoimmunotherapy for Non-small Cell Lung Cancer (SCIENCE Study) is a phase 3, randomised interventional study registered as NCT07617389 by Wen-zhao ZHONG, with a registry enrolment figure of 358 participants, started 2026-05-20 and due to reach its primary completion in 2030-05-15. Interventions recorded: selective mediastinal lymph node sampling; systematic mediastinal lymph node dissection. Conditions listed: Stage IIA-IIIB NSCLC; Selective Mediastinal Lymph Node Sampling; Systematic medIastinal Lymph Node Dissection. Primary outcome: 2-year event-free survival (EFS) rate. Lung eligibility wording from the registry: \"Histologically or pathologically confirmed peripheral non-small cell lung cancer (NSCLC), with clinical tumor, node, metastasis(TNM) stage IIA-IIIB, which according to the International Association for the Study of Lung Cancer(IASLC) 9th edition, and no known epidermal growth factor receptor (EGFR) \". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07617389","url":"https://clinicaltrials.gov/study/NCT07617389"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07617389","phase":"3","setting":"Selective Mediastinal Lymph Node Sampling Versus Systematic medIastinal Lymph Node Dissection After Neoadjuvant Chemotherapy Combined With Immunotherapy for the Treatment of Clinical Stage IIA-IIIB (N2) Non-small Cell Lung Cancer","sponsor":"Wen-zhao ZHONG","started":"2026-05-20","startedType":"estimated","enrolled":358,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04428905","kind":"trial","name":"Self-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by City of Hope Medical Center, active but no longer recruiting.","summary":"Self-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer is a phase 3, randomised interventional study registered as NCT04428905 by City of Hope Medical Center, with a registry enrolment figure of 403 participants, started 2020-07-11 and due to reach its primary completion in 2027-03-31. Interventions recorded: Quality-of-Life Assessment; Questionnaire Administration; Survivorship Care Plan; Telemedicine. Conditions listed: Lung Non-Small Cell Carcinoma; Stage I Colorectal Cancer AJCC v8; Stage I Lung Cancer AJCC v8; Stage IA1 Lung Cancer AJCC v8; Stage IA2 Lung Cancer AJCC v8; Stage IA3 Lung Cancer AJCC v8; Stage IB Lung Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage IIA Colorectal Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Colorectal Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage IIC Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8. Primary outcome: Care coordination; Care coordination; Care coordination. Colorectal eligibility wording from the registry: \"* Non-small cell lung cancer (NSCLC) and colorectal cancer survivors who are 4 months post-treatment completion\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04428905","url":"https://clinicaltrials.gov/study/NCT04428905"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04428905","phase":"3","setting":"Self-Management to Optimize Survivorship Care and Outcomes in Lung and Colorectal Cancers","sponsor":"City of Hope Medical Center","started":"2020-07-11","startedType":"actual","enrolled":403,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02227251","kind":"trial","name":"Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","aka":[],"tldr":"A phase 2 trial of Selinexor in diffuse large b-cell lymphoma, run by Karyopharm Therapeutics Inc, active and no longer recruiting.","summary":"Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) is a phase 2 interventional study registered as NCT02227251 by Karyopharm Therapeutics Inc, with 244 participants planned, started 2014-11 and due to reach its primary completion in 2026-12. Interventions recorded: Selinexor, Selinexor, Selinexor. Conditions listed: Diffuse Large B-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02227251","url":"https://clinicaltrials.gov/study/NCT02227251"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["selinexor"],"companies":["karyopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02227251","phase":"2","setting":"A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","sponsor":"Karyopharm Therapeutics Inc","started":"2014-11","startedType":"actual","enrolled":244,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05035745","kind":"trial","name":"Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)","aka":["START"],"tldr":"A phase 1/2 trial of talazoparib and selinexor in triple-negative breast cancer, run by National University Hospital, Singapore, now recruiting.","summary":"Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START) is a phase 1/2, interventional study registered as NCT05035745 by National University Hospital, Singapore, with a registry enrolment figure of 63 participants, started 2021-03-01 and due to reach its primary completion in 2027-11. Interventions recorded: Talazoparib; Selinexor. Conditions listed: Advanced Refractory Solid Tumors; Advanced Triple Negative Breast Cancers; Metastatic Triple Negative Breast Cancers. Triple-negative eligibility wording from the registry: \"b) Dose expansion phase: Patients with previously treated, advanced or metastatic histologically or cytologically confirmed triple negative breast cancers\". Sites: Singapore. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05035745","url":"https://clinicaltrials.gov/study/NCT05035745"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["talazoparib","selinexor"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05035745","phase":"1/2","setting":"Phase I Dose Finding Study of Selinexor and Talazoparib in Patients With Advanced Refractory Solid Tumors, Followed by Phase II Expansion Cohort Study in Patients With Advanced/ Metastatic Triple Negative Breast Cancers. (START)","sponsor":"National University Hospital, Singapore","started":"2021-03-01","startedType":"actual","enrolled":63,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02343042","kind":"trial","name":"Selinexor and Backbone Treatments of Multiple Myeloma Patients","aka":["STOMP"],"tldr":"A phase 1/2 trial of Selinexor, Dexamethasone, Lenalidomide in multiple myeloma, run by Karyopharm Therapeutics Inc, now recruiting.","summary":"Selinexor and Backbone Treatments of Multiple Myeloma Patients is a phase 1/2 interventional study registered as NCT02343042 by Karyopharm Therapeutics Inc, with 300 participants planned, started 2015-10 and due to reach its primary completion in 2027-04. Interventions recorded: Selinexor, Dexamethasone, Lenalidomide, Pomalidomide, Bortezomib. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02343042","url":"https://clinicaltrials.gov/study/NCT02343042"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["selinexor","dexamethasone","lenalidomide","pomalidomide","bortezomib","daratumumab"],"companies":["karyopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02343042","phase":"1/2","setting":"A Phase 1b/2 Study of Selinexor (KPT-330) in Combination With Backbone Treatments for Relapsed/Refractory Multiple Myeloma and Newly Diagnosed Multiple Myeloma","sponsor":"Karyopharm Therapeutics Inc","started":"2015-10","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06946420","kind":"trial","name":"SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy","aka":["SENECA"],"tldr":"A phase 3 trial in pancreatic cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS, active but no longer recruiting.","summary":"SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy is a phase 3, randomised interventional study registered as NCT06946420 by Fondazione Policlinico Universitario Agostino Gemelli IRCCS, with a registry enrolment figure of 108 participants, started 2025-01-10 and due to reach its primary completion in 2030-01-10. Interventions recorded: SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy; Standard systemic therapy (chemotherapy) without RT/SBRT. Conditions listed: Radiation Therapy; SBRT; Pancreatic Cancer Metastatic. Primary outcome: Absence of symtomps. Pancreatic eligibility wording from the registry: \"* Patients diagnosed with pancreatic cancer, metastatic, candidate for first-line treatment standard systemic; either newly diagnosed in metastatic stage or first progression to metastasis\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06946420","url":"https://clinicaltrials.gov/study/NCT06946420"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06946420","phase":"3","setting":"SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy, a Phase III Randomized Multicentric Trial","sponsor":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","started":"2025-01-10","startedType":"actual","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"senomac","kind":"trial","name":"SENOMAC","aka":["Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases"],"tldr":"The trial that closed the argument Z0011 opened. Even when a node holds a deposit bigger than two millimetres, and even after a mastectomy, leaving the rest of the armpit alone was as safe, provided the nodes were treated with radiotherapy.","summary":"SENOMAC was designed against the three criticisms of Z0011: too few patients, no mastectomy patients, and uncertainty about what the radiotherapy fields actually covered. Between January 2015 and December 2021 it enrolled 2,766 patients in five countries with clinically node-negative T1 to T3 breast cancer and one or two sentinel node macrometastases, and randomised them to completion axillary clearance or to sentinel node biopsy alone. The per-protocol population was 2,540. Radiotherapy including nodal target volumes was given to 89.9 percent of the sentinel node-only group and 88.4 percent of the dissection group, and that is recorded rather than assumed.\n\nAt a median 46.8 months, estimated five-year recurrence-free survival was 89.7 percent (95 percent confidence interval 87.5 to 91.9) with sentinel node biopsy alone and 88.7 percent (86.3 to 91.1) with clearance, a country-adjusted hazard ratio for recurrence or death of 0.89 (0.66 to 1.19), significantly below the non-inferiority margin of 1.44 (p<0.001).\n\nWhat SENOMAC does not do is remove the nodal radiotherapy. Nine in ten patients had it, so the trial tests omitting the operation, not omitting treatment of the axilla. POSNOC, which forbids axillary and supraclavicular radiotherapy in its experimental arm, is the trial that tests the stronger claim.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02240472","url":"https://clinicaltrials.gov/study/NCT02240472"},{"label":"SENOMAC (New England Journal of Medicine 2024)","url":"https://doi.org/10.1056/NEJMoa2313487"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["sentinel-node","imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":["karolinska"],"pathways":[],"terms":["sentinel-lymph-node-biopsy","lymphadenectomy","axillary-surgery-de-escalation","breast-cancer-related-lymphoedema"],"trials":["acosog-z0011","ibcsg-23-01","amaros","posnoc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02240472","phase":"3","setting":"Clinically node-negative T1 to T3 breast cancer with one or two sentinel node macrometastases larger than 2 mm: completion axillary clearance against sentinel node biopsy alone, with overall survival as the primary endpoint and recurrence-free survival reported first, non-inferiority margin 1.44","sponsor":"Karolinska Institutet, with the Swedish Research Council","result":"Five-year recurrence-free survival 89.7 percent with sentinel node biopsy alone against 88.7 percent with completion axillary clearance (hazard ratio 0.89, 0.66 to 1.19, non-inferior).","started":"2015-01-27","startedType":"actual","yearReported":2024,"enrolled":2766,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Sentinel node biopsy only","n":1335,"value":89.7,"note":"95 percent confidence interval 87.5 to 91.9"},{"name":"Completion axillary lymph node dissection","n":1205,"value":88.7,"note":"95 percent confidence interval 86.3 to 91.1"}],"hr":0.89,"ci":[0.66,1.19],"p":"<0.001 for non-inferiority","source":"https://doi.org/10.1056/NEJMoa2313487"}],"replication":"Z0011 and IBCSG 23-01 reached the same conclusion in smaller and lower-burden populations; POSNOC is testing whether the nodal radiotherapy can also go."},{"id":"senticol-iii","kind":"trial","name":"SENTICOL III","aka":[],"tldr":"Tests whether removing only the first draining lymph nodes is safe enough to spare women the lymphoedema of full node removal.","summary":"SENTICOL III, trial NCT03386734 sponsored by ARCAGY-GINECO and ENGOT, tests whether removing only the first draining lymph nodes is safe enough in early-stage cervical cancer to spare women the lymphoedema of full pelvic lymphadenectomy. It is a non-inferiority trial of about 950 patients comparing sentinel lymph node biopsy alone with sentinel node biopsy plus full lymphadenectomy, with disease-free survival and quality of life as endpoints, following the SENTICOL I and II accuracy studies and the single-arm SENTIX trial, with readout expected in 2027 to 2028. OnCo links it to cervical cancer and sentinel lymph node biopsy. It is recruiting with no results, and whether the sentinel-only approach that is now standard in endometrial cancer holds in cervical cancer, where missed nodal disease is harder to salvage, is the question it will answer.","status":"active","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03386734","url":"https://clinicaltrials.gov/study/NCT03386734"}],"tags":[],"related":[],"cancers":["cervical","early-cervical-cancer"],"sections":[],"technologies":["sentinel-node"],"targets":[],"drugs":[],"companies":["arcagy-gineco"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03386734","phase":"3","setting":"Early-stage cervical cancer: sentinel lymph node biopsy alone vs sentinel node plus full pelvic lymphadenectomy","sponsor":"ARCAGY-GINECO / ENGOT","started":"2018-05-03","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"nct01276054","kind":"trial","name":"Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients","aka":[],"tldr":"A phase 2 trial of Technetium Tc-99m sulfur colloid in Breast cancer, run by University of Southern California, recorded as terminated on the registry.","summary":"Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients is a phase 2 interventional study registered as NCT01276054 by University of Southern California, with 4 participants recorded, started 2010-12 and due to reach its primary completion in 2011-10. Interventions recorded: technetium Tc 99m sulfur colloid, methylene blue, indocyanine green solution, sentinel lymph node biopsy, axillary lymph node biopsy, bioimpedance spectroscopy, quality-of-life assessment, lymphedema management. Conditions recorded: Lymphedema, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer.\n\nLinked to the drug Technetium Tc-99m sulfur colloid because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01276054","url":"https://clinicaltrials.gov/study/NCT01276054"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["technetium-sulfur-colloid"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01276054","phase":"2","setting":"Reducing the Incidence and Severity of Arm Lymphedema With Axillary Reverse Mapping and Implementation of a Lymphedema Screening and Intervention Program","sponsor":"University of Southern California","started":"2010-12","enrolled":4,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05263583","kind":"trial","name":"Sepantronium Bromide for the Treatment of High-grade B-cell Lymphoma","aka":[],"tldr":"A phase 2 trial of Sepantronium Bromide in non-Hodgkin lymphoma, burkitt lymphoma and diffuse large B-cell lymphoma, run by Cothera Bioscience, Inc, active and no longer recruiting.","summary":"Sepantronium Bromide for the Treatment of High-grade B-cell Lymphoma is a phase 2 interventional study registered as NCT05263583 by Cothera Bioscience, Inc, with 14 participants enrolled, started 2022-12-09 and due to reach its primary completion in 2025-03-01. Interventions recorded: Sepantronium Bromide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05263583","url":"https://clinicaltrials.gov/study/NCT05263583"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","burkitt-lymphoma","dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05263583","phase":"2","setting":"A Phase 2, Multicenter, Open Label Dose-ranging Study of Sepantronium Bromide in Patients With Relapsed/Refractory c-Myc Rearranged High-grade B-cell Lymphoma (HGBCL)","sponsor":"Cothera Bioscience, Inc","started":"2022-12-09","startedType":"actual","enrolled":14,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01985724","kind":"trial","name":"Sequential Administration of FE75C and Docetaxel Versus Docetaxel/Cyclophosphamide in HER-2 Negative, Node Positive Breast Cancer","aka":[],"tldr":"A phase 3 trial of Docetaxel, Epirubicin, Cyclophosphamide, Fluorouracil, Lenograstim and Pegfilgrastim in Breast cancer, run by Hellenic Oncology Research Group, completed.","summary":"Sequential Administration of FE75C and Docetaxel Versus Docetaxel/Cyclophosphamide in HER-2 Negative, Node Positive Breast Cancer is a phase 3 interventional study registered as NCT01985724 by Hellenic Oncology Research Group, with 650 participants recorded, started 2007-10 and reaching its primary completion in 2013-12. Interventions recorded: Docetaxel, Epirubicin, Cyclophosphamide, 5-fluoruracil, Granulocyte-colony stimulating growth factor. Conditions recorded: Breast Cancer.\n\nLinked to the drug Lenograstim because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01985724","url":"https://clinicaltrials.gov/study/NCT01985724"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["docetaxel","epirubicin","cyclophosphamide","fluorouracil","lenograstim","pegfilgrastim"],"companies":["horg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01985724","phase":"3","setting":"A Multicenter Randomized Study Comparing the Dose Dense, G-CSF-supported Sequential Administration of FE75C Followed by Docetaxel Versus Docetaxel/Cyclophosphamide Doublet as Adjuvant Chemotherapy in Women With HER-2 Negative, Axillary Lymph Node Positive Breast Cancer","sponsor":"Hellenic Oncology Research Group","started":"2007-10","enrolled":650,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07025174","kind":"trial","name":"Sequential Anti-Angiogenic Therapy After Immunotherapy in Advanced Biliary Tract Cancer","aka":["SAIB"],"tldr":"A phase 2 trial of gemcitabine, cisplatin, oxaliplatin and other drugs in gallbladder cancer and other biliary tract cancers, run by First Affiliated Hospital of Zhejiang University, now recruiting.","summary":"Sequential Anti-Angiogenic Therapy After Immunotherapy in Advanced Biliary Tract Cancer is a phase 2, randomised interventional study registered as NCT07025174 by First Affiliated Hospital of Zhejiang University, with a registry enrolment figure of 60 participants, started 2025-06-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: PD-1/CTLA-4 Dual Functional Antibody, Gemcitabine, Cisplatin, Anlotinib, Oxaliplatin + 5-Fluorouracil/Leucovorin. Conditions listed: Bile Duct Carcinoma, Gall Bladder Cancer, Biliary Tract Cancer, Cholangiocarcinoma. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07025174","url":"https://clinicaltrials.gov/study/NCT07025174"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","kinase-inhibitors"],"targets":[],"drugs":["gemcitabine","cisplatin","oxaliplatin","fluorouracil","leucovorin","anlotinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07025174","phase":"2","setting":"Evaluation of the Effect of Sequential Anti-angiogenic Therapy Following Immune Therapy Progression on Survival in Patients With Advanced Biliary Tract Malignancies: A Randomized, Multi-center, Exploratory Clinical Study","sponsor":"First Affiliated Hospital of Zhejiang University","started":"2025-06-01","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07181499","kind":"trial","name":"Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI","aka":[],"tldr":"A phase 2 trial of Carboplatin and Pemetrexed in non-small-cell lung cancer, run by Betta Pharmaceuticals Co., Ltd., now recruiting.","summary":"Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI is a phase 2 interventional study registered as NCT07181499 by Betta Pharmaceuticals Co., Ltd., with 28 participants planned, started 2025-09 and due to reach its primary completion in 2028-11. Interventions recorded: Befotertinib and Pemetrexed + Carboplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07181499","url":"https://clinicaltrials.gov/study/NCT07181499"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["carboplatin","pemetrexed","befotertinib"],"companies":["betta"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07181499","phase":"2","setting":"A Study Evaluating the Efficacy and Safety of Pemetrexed Combined With Platinum-Based Chemotherapy Followed by Befotertinib in Patients With Non-Small Cell Lung Cancer After Third-Generation EGFR TKI Resistance","sponsor":"Betta Pharmaceuticals Co., Ltd.","started":"2025-09","startedType":"estimated","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06522919","kind":"trial","name":"Sequential Immunochemotherapy Treatment with Pembrolizumab Plus Dendritic Cell (DC) Vaccine Followed by Trifluridine/Tipiracil Plus Bevacizumab in Refractory Mi","aka":["CombiCoR-Vax"],"tldr":"A phase 2 trial in colorectal cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS, now recruiting.","summary":"Sequential Immunochemotherapy Treatment with Pembrolizumab Plus Dendritic Cell (DC) Vaccine Followed by Trifluridine/Tipiracil Plus Bevacizumab in Refractory Mismatch-repair-proficient (pMMR) or Microsatellite-stable (MSS) Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06522919 by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS, with a registry enrolment figure of 36 participants, started 2025-01-07 and due to reach its primary completion in 2026-04-01. Interventions recorded: Autologous Dendritic Cell (DC) Vaccine. Conditions listed: Colorectal Cancer Metastatic; Microsatellite Stable Colorectal Carcinoma; Refractory Mismatch-repair-proficient (pMMR) Metastatic Colorectal Cancer. Primary outcome: Overall Response Rate (ORR). Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06522919","url":"https://clinicaltrials.gov/study/NCT06522919"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["shared-antigen-vaccine"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06522919","phase":"2","setting":"Sequential Immunochemotherapy Treatment with Pembrolizumab Plus Dendritic Cell (DC) Vaccine Followed by Trifluridine/Tipiracil (FTD/TPI) Plus Bevacizumab in Refractory Mismatch-repair-proficient (pMMR) or Microsatellite-stable (MSS) Metastatic Colorectal Cancer (CombiCoR-Vax)","sponsor":"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","started":"2025-01-07","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05806931","kind":"trial","name":"Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer","aka":["SCOTI"],"tldr":"A phase 2 trial of bevacizumab (glioblastoma use) in colorectal cancer, run by Rutgers, The State University of New Jersey, now recruiting.","summary":"Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT05806931 by Rutgers, The State University of New Jersey, with a registry enrolment figure of 50 participants, started 2023-05-17 and due to reach its primary completion in 2026-05-01. Interventions recorded: TAS-102, oxaliplatin, irinotecan with bevacizumab. Conditions listed: Colon Cancer; Rectal Cancer. Primary outcome: Disease control rate (DCR):. Colorectal eligibility wording from the registry: \"* Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy that included 5-FU, irinotecan, oxaliplatin and appropriate antibody therapy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05806931","url":"https://clinicaltrials.gov/study/NCT05806931"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05806931","phase":"2","setting":"Sequential Combined TAS-102 and Oxaliplatin Alternating With TAS-102 and Irinotecan (Sequential TASOXIRI) With Bevacizumab for Late-Line Metastatic Colorectal Cancer","sponsor":"Rutgers, The State University of New Jersey","started":"2023-05-17","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04570943","kind":"trial","name":"Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer","aka":["GABRINOX-ART"],"tldr":"A phase 2 trial in pancreatic cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle, now recruiting.","summary":"Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT04570943 by Institut du Cancer de Montpellier - Val d'Aurelle, with a registry enrolment figure of 103 participants, started 2021-06-16 and due to reach its primary completion in 2028-01. Interventions recorded: Gabrinox; MRI-GUIDED STEREOTACTIC RADIOTHERAPY. Conditions listed: Locally Advanced Pancreatic Adenocarcinoma. Primary outcome: Rate of non-progression at 4 months; Acute gastrointestinal non-toxicity rate. Pancreatic eligibility wording from the registry: \"Histologically or cytologically proven pancreatic adenocarcinoma\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04570943","url":"https://clinicaltrials.gov/study/NCT04570943"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04570943","phase":"2","setting":"Phase II Study to Assess the Interest of a Sequential Treatment With Gemcitabine/Nab-paclitaxel (GEMBRAX) and Then FOLFIRINOX Followed by Stereotactic Magnetic Resonance-guided Adaptive Radiotherapy in Patients With Locally Advanced Pancreatic Cancer","sponsor":"Institut du Cancer de Montpellier - Val d'Aurelle","started":"2021-06-16","startedType":"actual","enrolled":103,"enrolledBasis":"registry","outcomes":[]},{"id":"sequoia","kind":"trial","name":"SEQUOIA","aka":["SEQUOIA pegilodecakin","AM0010 phase 3"],"tldr":"Zanubrutinib beat chemoimmunotherapy in untreated CLL and delivered a 72% five-year progression-free rate in the hardest genetic subgroup.","summary":"SEQUOIA, trial NCT03336333 sponsored by BeOne, formerly BeiGene, published in Lancet Oncology in 2022 with five-year data in JCO in 2025, showed that zanubrutinib beats bendamustine and rituximab in previously untreated chronic lymphocytic leukaemia unsuitable for FCR, and delivered a high five-year progression-free rate in del(17p) disease. Cohort 1 randomised 479 patients and met its primary progression-free survival endpoint with a large effect maintained at five years, arm C treated 111 patients with del(17p) with most progression-free at five years, and arm D combined zanubrutinib with venetoclax with very high undetectable MRD rates, the basis of the January 2023 CLL approval. Whether the arm D doublet becomes a fixed-duration standard is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03336333","url":"https://clinicaltrials.gov/study/NCT03336333"},{"label":"ClinicalTrials.gov NCT02923921","url":"https://clinicaltrials.gov/study/NCT02923921"},{"label":"Hecht et al., SEQUOIA (JCO 2021)","url":"https://doi.org/10.1200/JCO.20.02232"}],"tags":[],"related":[],"cancers":["cll","cll-treatment-naive","pancreatic","metastatic-pdac"],"sections":[],"technologies":["kinase-inhibitors","cytotoxic-chemotherapy"],"targets":["btk"],"drugs":["zanubrutinib","venetoclax","rituximab","pegilodecakin","folfox"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":["del17p-tp53","cold-vs-hot","pancreatic-failed-programmes"],"trials":[],"people":["oyler-john","constantine-tam"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 5): Addenbrooke's Hospital Cambridge; Hammersmith Hospital; Velindre Hospital Cardiff; University College London Hospitals; Guy's and St Thomas'."],"nct":"NCT03336333","phase":"3","setting":"Previously untreated CLL/SLL unsuitable for FCR: zanubrutinib vs bendamustine-rituximab (cohort 1); zanubrutinib in del(17p) (arm C); zanubrutinib + venetoclax (arm D)","sponsor":"BeOne (BeiGene)","result":"PFS HR 0.42 vs BR; 5-year PFS 72.2% in del(17p).","started":"2017-10-31","startedType":"actual","yearReported":2022,"enrolled":590,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (cohort 1)","primary":true,"arms":[{"name":"Zanubrutinib","n":241},{"name":"Bendamustine + rituximab","n":238}],"hr":0.42,"ci":[0.28,0.63],"p":"<0.0001","source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00293-5/fulltext"},{"endpoint":"Progression-free survival at 5 years, del(17p) (arm C)","unit":"%","arms":[{"name":"Zanubrutinib","n":111,"value":72.2}],"source":"https://ashpublications.org/ashclinicalnews/news/8659/Five-Year-Results-of-SEQUOIA-Trial-Show"},{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Pegilodecakin + FOLFOX","n":283,"value":5.8},{"name":"FOLFOX","n":284,"value":6.3}],"hr":1.045,"ci":[0.863,1.265],"source":"https://doi.org/10.1200/JCO.20.02232"}],"replication":"ALPINE confirmed zanubrutinib's efficacy against ibrutinib in relapse; ELEVATE-TN shows the same class effect frontline."},{"id":"serena-6","kind":"trial","name":"SERENA-6","aka":[],"tldr":"The first trial to change treatment because of a blood test rather than a scan: switching to camizestrant when an ESR1 mutation appeared in the blood delayed progression by seven months.","summary":"3,256 patients screened by serial ctDNA; 315 with an emergent ESR1 mutation randomised. PFS 16.0 vs 9.2 months (HR 0.44, P<0.0001). OS immature; no crossover. FDA ODAC voted 6-3 against (30 April 2026), questioning the clinical meaning of acting on ctDNA before progression; the FDA nonetheless granted accelerated approval on 4 September 2026 (Etcamah), the first ctDNA-triggered switch indication.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04964934","url":"https://clinicaltrials.gov/study/NCT04964934"},{"label":"ASCO Post approval","url":"https://ascopost.com/news/september-2026/fda-approves-camizestrant-combination-regimen-for-locally-advanced-or-metastatic-breast-cancer/"},{"label":"ODAC vote (CancerNetwork)","url":"https://www.cancernetwork.com/view/fda-odac-no-camizestrant-for-hr-her2-esr1-advanced-breast-cancer"}],"tags":[],"related":["src-asco-post","src-cancer-network"],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["liquid-biopsy"],"targets":["estrogen-receptor"],"drugs":["camizestrant"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["esr1-mutation","ctdna"],"trials":[],"people":["nicholas-turner"],"bottlenecks":[],"keyPapers":["paper-serena-6-n-engl-j-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04964934","phase":"3","setting":"First-line HR+/HER2- advanced breast cancer on AI + CDK4/6 with an ESR1 mutation detected in ctDNA before radiographic progression: switch to camizestrant + CDK4/6 vs continue AI + CDK4/6","sponsor":"AstraZeneca","result":"PFS 16.0 vs 9.2 months, HR 0.44.","started":"2021-06-30","startedType":"actual","yearReported":2025,"enrolled":315,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Switch to camizestrant + CDK4/6","n":157,"value":16},{"name":"Continue AI + CDK4/6","n":158,"value":9.2}],"hr":0.44,"ci":[0.31,0.6],"p":"<0.0001","source":"https://www.onclive.com/view/fda-approves-camizestrant-plus-a-cdk4-6-inhibitor-for-emergent-esr1-mutated-hr-her2-advanced-breast-cancer"}],"replication":"Single trial; the strategy (ctDNA-triggered switch) has not been replicated with another agent. OS pending."},{"id":"nct04768426","kind":"trial","name":"Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of capecitabine in triple-negative breast cancer, run by Stanford University, now recruiting.","summary":"Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer is a phase 2, interventional study registered as NCT04768426 by Stanford University, with a registry enrolment figure of 40 participants, started 2021-02-03 and due to reach its primary completion in 2026-11. Interventions recorded: Capecitabine. Conditions listed: Triple Negative Breast Cancer; Breast Cancer. Triple-negative eligibility wording from the registry: \"Anatomic stage I - III triple-negative breast cancer at diagnosis\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04768426","url":"https://clinicaltrials.gov/study/NCT04768426"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04768426","phase":"2","setting":"Phase II Trial of Circulating Tumor DNA Monitoring During Adjuvant Capecitabine in Patients With Triple-negative Breast Cancer and Residual Disease Following Standard Neoadjuvant Chemotherapy","sponsor":"Stanford University","started":"2021-02-03","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04692103","kind":"trial","name":"Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy","aka":[],"tldr":"A phase 2 trial of Fluoroestradiol F-18 and Fludeoxyglucose F-18 in Breast cancer, run by University of Washington, active and no longer recruiting.","summary":"Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy is a phase 2 interventional study registered as NCT04692103 by University of Washington, with 2 participants planned, started 2021-07-10 and due to reach its primary completion in 2021-10-01. Interventions recorded: F-18 16 Alpha-Fluoroestradiol, Positron Emission Tomography, Computed Tomography, Fludeoxyglucose F-18, Positron Emission Tomography, Computed Tomography, Laboratory Biomarker Analysis. Conditions recorded: Estrogen Receptor Positive, Primary or Recurrent Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7.\n\nLinked to the drug Fludeoxyglucose F-18 because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04692103","url":"https://clinicaltrials.gov/study/NCT04692103"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["fluoroestradiol-f18","fludeoxyglucose-f18"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04692103","phase":"2","setting":"Serial [F-18] Fluoroestradiol (FES) PET Imaging to Evaluate Endocrine-targeted Therapy","sponsor":"University of Washington","started":"2021-07-10","startedType":"actual","yearReported":2023,"enrolled":2,"enrolledBasis":"registry","outcomes":[{"endpoint":"Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV) - Avg SULmax","primary":true,"unit":"%","arms":[{"name":"Diagnostic (F-18 FES PET/CT)","n":2,"value":78,"note":"range 77 to 79; Figures from the ClinicalTrials.gov results section (first posted 2023-02-21), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04692103?tab=results"}]},{"id":"nct07811076","kind":"trial","name":"Serine/Glycine-Restricted Diet With Chemoradiotherapy for Rectal Cancer","aka":["SG-RCT"],"tldr":"A phase 1/2 trial in colorectal cancer, run by Xuelei Ma MD, not yet recruiting.","summary":"Serine/Glycine-Restricted Diet With Chemoradiotherapy for Rectal Cancer is a phase 1/2, randomised interventional study registered as NCT07811076 by Xuelei Ma MD, with a registry enrolment figure of 140 participants, started 2026-08-31 and due to reach its primary completion in 2027-01-31. Interventions recorded: Serine/Glycine-Restricted Diet; CAPOX Chemotherapy; PD-1 Inhibitor; Short-Course Radiotherapy. Conditions listed: Locally Advanced Rectal Cancer (LARC). Primary outcome: Complete Response Rate (pCR + cCR). Colorectal eligibility wording from the registry: \"* Histologically confirmed locally advanced rectal cancer staged as cT3, cT4, or node-positive by pelvic MRI\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07811076","url":"https://clinicaltrials.gov/study/NCT07811076"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07811076","phase":"1/2","setting":"A Randomized Controlled Trial of Serine/Glycine-Restricted Diet Combined With Chemoradiotherapy and Immunotherapy for Neoadjuvant Treatment of Rectal Cancer","sponsor":"Xuelei Ma MD","started":"2026-08-31","startedType":"estimated","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05731726","kind":"trial","name":"Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of serplulimab, capecitabine, fOLFOX (5-FU, leucovorin, oxaliplatin) and celecoxib in colorectal cancer, run by Zhejiang University, now recruiting.","summary":"Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT05731726 by Zhejiang University, with a registry enrolment figure of 50 participants, started 2023-02-22 and due to reach its primary completion in 2026-12-30. Interventions recorded: Serplulimab; Capecitabine; Oxaliplatin; Celecoxib. Conditions listed: pMMR; MSS; MSI-L; Locally Advanced Rectal Carcinoma. Primary outcome: Pathological complete response rates. Colorectal eligibility wording from the registry: \"Histological or cytological documentation of adenocarcinoma of the rectum\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05731726","url":"https://clinicaltrials.gov/study/NCT05731726"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["serplulimab","capecitabine","folfox","celecoxib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05731726","phase":"2","setting":"A Phase II Study to Explore the Neoadjuvant Treatment of Serplulimab Combined With CAPEOX + Celecoxib in the Treatment of Locally Advanced Rectal Cancer","sponsor":"Zhejiang University","started":"2023-02-22","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07819604","kind":"trial","name":"Serplulimab Combined With CAPOX and Bevacizumab as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of serplulimab, cAPOX (capecitabine, oxaliplatin) and bevacizumab (glioblastoma use) in colorectal cancer, run by Xijing Hospital, not yet recruiting.","summary":"Serplulimab Combined With CAPOX and Bevacizumab as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT07819604 by Xijing Hospital, with a registry enrolment figure of 85 participants, started 2026-09-01 and due to reach its primary completion in 2027-09-01. Interventions recorded: Serplulimab; CAPOX; Bevacizumab. Conditions listed: Locally Advanced Colorectal Cancer. Primary outcome: Pathological Complete Response (pCR) Rate. Colorectal eligibility wording from the registry: \"* Histologically or pathologically confirmed locally advanced rectal adenocarcinoma, cT3/cT4N+M0 stage per AJCC/UICC 8th edition, with distance from anal verge ≤10 cm\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07819604","url":"https://clinicaltrials.gov/study/NCT07819604"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["serplulimab","capox","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07819604","phase":"2","setting":"A Single-Arm, Phase II, Multicenter Study of Serplulimab Combined With CAPOX Plus Bevacizumab as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer","sponsor":"Xijing Hospital","started":"2026-09-01","startedType":"estimated","enrolled":85,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05742425","kind":"trial","name":"Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases is a phase 2, interventional study registered as NCT05742425 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 30 participants, started 2023-03 and due to reach its primary completion in 2028-03. Interventions recorded: Serplulimab Combined With FOLFIRI and Bevacizumab. Conditions listed: Unresectable Colon Cancer Peritoneal Metastases; PMMR/Ras/BRAF Wild-type. Primary outcome: Disease-free survival (DFS). Colorectal eligibility wording from the registry: \"Colon cancer was confirmed by histology, and its gene detection was pMMR/MSS and RAS/BRAF wild-type\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05742425","url":"https://clinicaltrials.gov/study/NCT05742425"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05742425","phase":"2","setting":"The Efficacy and Safety of Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of pMMR/Ras/BRAF Wild-type Unresectable Colon Cancer Peritoneal Metastases: a Multicenter Single-arm Phase II Trial","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2023-03","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07691632","kind":"trial","name":"Serplulimab Plus Decitabine and CAPOX Before Surgery for Locally Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"Serplulimab Plus Decitabine and CAPOX Before Surgery for Locally Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT07691632 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 35 participants, started 2026-06-30 and due to reach its primary completion in 2027-12-31. Interventions recorded: Serplulimab + Decitabine + CAPOX (Oxaliplatin + Capecitabine). Conditions listed: Locally Advanced Colorectal Cancer; Colorectal Adenocarcinoma. Primary outcome: Pathological Complete Response Rate. Colorectal eligibility wording from the registry: \"* Histologically or pathologically confirmed colorectal adenocarcinoma with no prior antitumor treatment, staged as cT3/cT4N+M0 locally advanced colorectal cancer according to the AJCC/UICC 8th edition based on contrast-enhanced CT or MRI, with colonoscopy and/or diagnostic laparoscopy if clinically\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07691632","url":"https://clinicaltrials.gov/study/NCT07691632"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07691632","phase":"2","setting":"A Single-Arm, Single-Center, Phase II Exploratory Clinical Study of Serplulimab Combined With Decitabine Plus CAPOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2026-06-30","startedType":"estimated","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"sevilla","kind":"trial","name":"SEVILLA","aka":[],"tldr":"SEVILLA is a French-British randomised trial comparing ivonescimab, an antibody that blocks both PD-1 and the blood vessel signal VEGF, with FOLFOX chemotherapy as second-line treatment for bile duct and gallbladder cancer. University College London is the UK site.","summary":"SEVILLA (NCT06529718) is a randomised phase 2 run by UNICANCER at 42 sites in France and the United Kingdom, open since October 2025 with 72 patients planned and primary completion listed for August 2027. Eligible patients have histologically proven intrahepatic, perihilar or distal cholangiocarcinoma or gallbladder carcinoma (ampullary carcinoma excluded) that has progressed after first-line treatment, and are randomised to the PD-1 and VEGF bispecific antibody ivonescimab or to FOLFOX, the ABC-06 standard. The primary endpoint is progression-free survival. It is one of the first trials to test a bispecific immunotherapy against chemotherapy in second-line biliary cancer and gives UK patients with gallbladder cancer a randomised second-line option.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06529718","url":"https://clinicaltrials.gov/study/NCT06529718"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":["pd1","vegf"],"drugs":["ivonescimab","folfox"],"companies":["unicancer"],"institutions":["uclh"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (1, registry): University College London (London)."],"nct":"NCT06529718","phase":"2","setting":"Second-line locally advanced or metastatic biliary cancer (intrahepatic, perihilar or distal cholangiocarcinoma, or gallbladder carcinoma; ampullary excluded): ivonescimab versus FOLFOX, randomised, primary endpoint progression-free survival","sponsor":"UNICANCER","started":"2025-10-09","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04947189","kind":"trial","name":"Seviteronel in Combination With Chemotherapy in Androgen-receptor Positive Metastatic Triple-negative Breast Cancer","aka":["4CAST"],"tldr":"A phase 1/2 trial of dexamethasone and docetaxel in triple-negative breast cancer, run by St Vincent's Hospital, Sydney, now recruiting.","summary":"Seviteronel in Combination With Chemotherapy in Androgen-receptor Positive Metastatic Triple-negative Breast Cancer is a phase 1/2, interventional study registered as NCT04947189 by St Vincent's Hospital, Sydney, with a registry enrolment figure of 65 participants, started 2022-11-01 and due to reach its primary completion in 2026-07. Interventions recorded: Seviteronel-D (Seivteronel in combination with dexamethasone); Docetaxel. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \", IHC 3+ or in situ hybridisation (ISH) positive according to standard ASCO/CAP guidelines or triple-negative breast cancer, i\". Sites: Australia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04947189","url":"https://clinicaltrials.gov/study/NCT04947189"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["dexamethasone","docetaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04947189","phase":"1/2","setting":"4CAST: A Phase 1b Dose Exploration and Dose Expansion, Open-label, Single-centre Study Evaluating the Safety and Efficacy of INO-464 in Combination With Chemotherapy in Patients With metASTatic Breast Cancer","sponsor":"St Vincent's Hospital, Sydney","started":"2022-11-01","startedType":"actual","enrolled":65,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07131319","kind":"trial","name":"SFRT+Tislelizumab+Platinum Chemotherapy for Unresectable Stage III NSCLC","aka":[],"tldr":"A phase 2/3 trial in lung cancer, run by Second Affiliated Hospital of Nanchang University, now recruiting.","summary":"SFRT+Tislelizumab+Platinum Chemotherapy for Unresectable Stage III NSCLC is a phase 2/3, interventional study registered as NCT07131319 by Second Affiliated Hospital of Nanchang University, with a registry enrolment figure of 30 participants, started 2025-04-21 and due to reach its primary completion in 2028-10-31. Interventions recorded: Spatially Fractionated Radiotherapy (SFRT); Tislelizumab, Carboplatin, Pemetrexed; Tislelizumab, paclitaxel, Carboplatin. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Surgical resection rate. Lung eligibility wording from the registry: \"* The patient has histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC) that is deemed unresectable after discussion in the multidisciplinary team (MDT), which is classified as T3-4N1-2M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07131319","url":"https://clinicaltrials.gov/study/NCT07131319"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07131319","phase":"2/3","setting":"Spatially Fractionated Radiotherapy (SFRT) Synchronized With Tislelizumab Plus Platinum-based Dual-agent Chemotherapy for Induction Treatment of Initially Unresectable Stage III Non-small Cell Lung Cancer: A Clinical Study","sponsor":"Second Affiliated Hospital of Nanchang University","started":"2025-04-21","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06080776","kind":"trial","name":"SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB NSCLC With Sensitizing EGFR Mutations","aka":[],"tldr":"A phase 3 trial of SH-1028 tablets in non-small-cell lung cancer, run by Nanjing Sanhome Pharmaceutical, Co., Ltd., now recruiting.","summary":"SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB NSCLC With Sensitizing EGFR Mutations is a phase 3 interventional study registered as NCT06080776 by Nanjing Sanhome Pharmaceutical, Co., Ltd., with 242 participants planned, started 2023-05-11 and due to reach its primary completion in 2028-02-01. Interventions recorded: SH-1028 tablets and Placebo SH-1028 tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06080776","url":"https://clinicaltrials.gov/study/NCT06080776"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":[],"targets":["egfr"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06080776","phase":"3","setting":"A Phase III, Double-blind, Randomised Study of SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With Sensitizing EGFR Mutations","sponsor":"Nanjing Sanhome Pharmaceutical, Co., Ltd.","started":"2023-05-11","startedType":"actual","enrolled":242,"enrolledBasis":"registry","outcomes":[]},{"id":"shape","kind":"trial","name":"SHAPE (CCTG CX.5)","aka":["SHAPE","CX.5","GCIG SHAPE"],"tldr":"SHAPE showed that women with small, low-risk cervical cancers can safely have a simple hysterectomy rather than the more extensive radical operation, with the same low rate of recurrence and fewer bladder and sexual problems.","summary":"Radical hysterectomy removes the parametrial tissue and upper vagina along with the uterus and carries lasting urinary, bowel and sexual side effects. SHAPE, run by the Canadian Cancer Trials Group with the Gynecologic Cancer InterGroup, randomised 700 women with low-risk early cervical cancer (2 cm or less, less than 10 mm of stromal invasion, no node involvement on imaging) to simple or radical hysterectomy, both with pelvic node assessment. The primary endpoint was pelvic recurrence at three years, tested for non-inferiority.\n\nPelvic recurrence at three years was low and non-inferior with simple hysterectomy, and urinary incontinence and retention were less frequent. The result, published in the New England Journal of Medicine in 2024, made simple hysterectomy a standard for this carefully defined low-risk group and reversed the trend towards ever more radical surgery.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01658930","url":"https://clinicaltrials.gov/study/NCT01658930"}],"tags":["subtype-trials"],"related":[],"cancers":["early-cervical-cancer","cervical"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["cctg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["marie-plante"],"bottlenecks":[],"keyPapers":["paper-shape-nejm-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01658930","phase":"3","setting":"Low-risk early-stage cervical cancer (stage IA2 or IB1, 2 cm or less, limited stromal invasion): simple hysterectomy against radical hysterectomy, both with pelvic lymph node assessment","sponsor":"Canadian Cancer Trials Group","result":"Simple hysterectomy was non-inferior to radical hysterectomy for three-year pelvic recurrence in low-risk early cervical cancer, with fewer urinary complications.","started":"2012-12-10","startedType":"actual","yearReported":2024,"enrolled":700,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pelvic recurrence at 3 years (non-inferiority)","primary":true,"unit":"%","arms":[{"name":"Simple hysterectomy","n":350,"value":2.52,"note":"Absolute difference 0.35 percentage points (90% CI -1.62 to 2.32); non-inferiority margin 4 points; median follow-up 4.5 years"},{"name":"Radical hysterectomy","n":350,"value":2.17}],"source":"https://doi.org/10.1056/NEJMoa2308900"},{"endpoint":"Urinary incontinence beyond 4 weeks after surgery","unit":"%","arms":[{"name":"Simple hysterectomy","n":350,"value":4.7},{"name":"Radical hysterectomy","n":350,"value":11}],"p":"0.003","source":"https://doi.org/10.1056/NEJMoa2308900"},{"endpoint":"Urinary retention beyond 4 weeks after surgery","unit":"%","arms":[{"name":"Simple hysterectomy","n":350,"value":0.6},{"name":"Radical hysterectomy","n":350,"value":9.9}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa2308900"}]},{"id":"nct00026117","kind":"trial","name":"Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer","aka":[],"tldr":"A phase 3 trial of Shark cartilage in Breast cancer and Colorectal cancer, run by Alliance for Clinical Trials in Oncology, completed.","summary":"Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer is a phase 3 interventional study registered as NCT00026117 by Alliance for Clinical Trials in Oncology, with 88 participants recorded, started 2001-08 and reaching its primary completion in 2006-09. Interventions recorded: BenFin, placebo. Conditions recorded: Breast Cancer, Colorectal Cancer.\n\nLinked to the technology Shark cartilage because the registry's title names it (\"shark cartilage\") and Breast cancer and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00026117","url":"https://clinicaltrials.gov/study/NCT00026117"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer","colorectal"],"sections":[],"technologies":["shark-cartilage"],"targets":[],"drugs":[],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00026117","phase":"3","setting":"Phase III Evaluation Of Benefin Shark Cartilage In Patients With Advanced Cancer","sponsor":"Alliance for Clinical Trials in Oncology","started":"2001-08","enrolled":88,"enrolledBasis":"registry","outcomes":[]},{"id":"sharp","kind":"trial","name":"SHARP","aka":[],"tldr":"SHARP was the 2008 trial that gave liver cancer its first life-extending drug.","summary":"SHARP, trial NCT00105443 sponsored by Bayer and reported in 2008, was the trial that gave liver cancer its first life-extending drug, sorafenib. It randomised 602 patients with advanced hepatocellular carcinoma and preserved liver function to sorafenib or placebo, met its primary overall survival endpoint and delayed radiological progression, while the response rate was only about two percent, establishing that disease stabilisation rather than shrinkage drives benefit with anti-angiogenic drugs. OnCo links it to hepatocellular carcinoma, sorafenib and Josep M. Llovet, and the result was confirmed by the parallel Asia-Pacific trial and a decade of real-world use as the control arm of later trials. Whether any of the many drugs that failed to beat sorafenib were undone by the trial design rather than by biology is the question its long reign left behind.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00105443","url":"https://clinicaltrials.gov/study/NCT00105443"}],"tags":[],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["sorafenib"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["josep-llovet"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00105443","phase":"3","setting":"Advanced HCC, Child-Pugh A, no prior systemic therapy: sorafenib vs placebo","sponsor":"Bayer","result":"OS 10.7 vs 7.9 months, HR 0.69.","started":"2005-03","yearReported":2008,"enrolled":602,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Sorafenib","n":299,"value":10.7},{"name":"Placebo","n":303,"value":7.9}],"hr":0.69,"ci":[0.55,0.87],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa0708857"},{"endpoint":"Time to radiologic progression","unit":"months","arms":[{"name":"Sorafenib","value":5.5},{"name":"Placebo","value":2.8}],"hr":0.58,"source":"https://doi.org/10.1056/NEJMoa0708857"}],"replication":"Confirmed by the parallel Asia-Pacific trial (Cheng 2009) and a decade of real-world use."},{"id":"shine","kind":"trial","name":"SHINE","aka":["Ibrutinib with bendamustine and rituximab in untreated mantle cell lymphoma","SHINE trial"],"tldr":"Adding a targeted tablet to first-line chemotherapy gave older people with mantle cell lymphoma about two and a half more years before the disease returned, but they did not live longer.","summary":"SHINE randomised 523 people aged 65 or over with untreated mantle cell lymphoma to ibrutinib 560 mg daily until progression or unacceptable toxicity (261) or placebo (262), each with six cycles of bendamustine 90 mg per square metre and rituximab, followed by up to twelve further doses of rituximab maintenance every eight weeks in responders.\n\nAt a median follow-up of 84.7 months, median progression-free survival was 80.6 months with ibrutinib against 52.9 months with placebo (hazard ratio 0.75, 95 per cent confidence interval 0.59 to 0.96, p = 0.01). Complete response was 65.5 against 57.6 per cent (p = 0.06). Overall survival was similar in the two groups. Grade 3 or 4 adverse events during treatment occurred in 81.5 per cent against 77.3 per cent.\n\nTwenty-eight months of extra progression-free time is a large number in a disease that is not curable with chemotherapy, and it did not translate into longer life, which is the finding that shaped what came next. The ECHO trial repeated the design with acalabrutinib, a more selective Bruton tyrosine kinase inhibitor chosen for lower toxicity, and ENRICH took the opposite route and removed the chemotherapy entirely.","status":"mixed","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT01776840","url":"https://clinicaltrials.gov/study/NCT01776840"},{"label":"New England Journal of Medicine 2022","url":"https://doi.org/10.1056/NEJMoa2201817"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["mantle-cell-lymphoma","non-hodgkin-lymphoma"],"sections":["targeted-therapy","chemotherapy"],"technologies":[],"targets":["btk","cd20","ccnd1"],"drugs":["ibrutinib","bendamustine","rituximab"],"companies":["johnson-johnson"],"institutions":[],"pathways":["bcr-signalling"],"terms":["maintenance-therapy","lymphoma-tx-maintenance"],"trials":["triangle","enrich"],"people":["michael-wang","martin-dreyling"],"bottlenecks":["b-toxicity-qol","b-aging-comorbidity"],"keyPapers":["paper-shine-ibrutinib-bendamustine-rituximab-mantle-cell-nejm-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01776840","phase":"3","setting":"Aged 65 or over with untreated mantle cell lymphoma: ibrutinib added to six cycles of bendamustine and rituximab, with rituximab maintenance","sponsor":"Janssen Research & Development, LLC","result":"Median progression-free survival 80.6 against 52.9 months (hazard ratio 0.75, p = 0.01) with no overall survival difference.","started":"2013-05-16","startedType":"actual","yearReported":2022,"enrolled":523,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Ibrutinib with bendamustine and rituximab","n":261,"value":80.6},{"name":"Placebo with bendamustine and rituximab","n":262,"value":52.9}],"hr":0.75,"ci":[0.59,0.96],"p":"0.01","source":"https://doi.org/10.1056/NEJMoa2201817"},{"endpoint":"Complete response rate","unit":"%","arms":[{"name":"Ibrutinib with bendamustine and rituximab","n":261,"value":65.5},{"name":"Placebo with bendamustine and rituximab","n":262,"value":57.6}],"p":"0.06"}],"replication":"Reproduced in direction and magnitude by ECHO with acalabrutinib; ENRICH tested a chemotherapy-free alternative in the same age group."},{"id":"nct07059949","kind":"trial","name":"Short Course Radiotherapy Followed by CAPOX and Carrilizumab and Bevacizumab or Cetuximab for the Initial Treatment of Unresectable Metastatic Rectal Cancer","aka":["Union-mRC"],"tldr":"A phase 2 trial in colorectal cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, not yet recruiting.","summary":"Short Course Radiotherapy Followed by CAPOX and Carrilizumab and Bevacizumab or Cetuximab for the Initial Treatment of Unresectable Metastatic Rectal Cancer is a phase 2, interventional study registered as NCT07059949 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 80 participants, started 2025-06-30 and due to reach its primary completion in 2027-01-30. Interventions recorded: CAPOX+ Camrelizumab+ Cetuximab; CAPOX+ Camrelizumab+ Bevacizumab. Conditions listed: Unresectable Metastatic Rectal Cancer; CAPOX; Combination of Radioimmunotherapy. Primary outcome: ORR. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal cancer with initial treatment (no surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy);\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07059949","url":"https://clinicaltrials.gov/study/NCT07059949"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07059949","phase":"2","setting":"Phase II, Single-center Study of Short-course Radiotherapy Followed by CAPOX and Carrelizumab and Bevacizumab or Cetuximab in the Treatment of Initially Unresectable Metastatic Rectal Cancer","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2025-06-30","startedType":"estimated","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04246684","kind":"trial","name":"Short RT Versus RCT,Followed by Chemo and Organ Preservation for Interm and High-risk Rectal Cancer Patients","aka":[],"tldr":"A phase 3 trial of fluorouracil (5-FU) in colorectal cancer, run by Prof. Dr. med. Claus Rödel, active but no longer recruiting.","summary":"Short RT Versus RCT,Followed by Chemo and Organ Preservation for Interm and High-risk Rectal Cancer Patients is a phase 3, randomised interventional study registered as NCT04246684 by Prof. Dr. med. Claus Rödel, with a registry enrolment figure of 702 participants, started 2020-11-05 and due to reach its primary completion in 2026-09-15. Interventions recorded: Oxaliplatin, 85 mg/m2; 5FU; 2400 mg/m2; 5FU, 250 mg/m2; 5FU, 2400 mg/m2; Oxaliplatin 50 mg/m2; Folinic Acid, 400 mg/m2; Radiotherapy control, 5x5 Gy: 25 Gy; Capecitabine, 1000 mg/m2; Oxaliplatin 85 mg/m2; radiotherapy experimental, 30 x 1,8 Gy: 54 Gy; Capecitabine, 825 mg/m2; Oxaliplatin, 130 mg/m2. Conditions listed: Rectal Cancer Stage III. Primary outcome: organ preservation. Colorectal eligibility wording from the registry: \"* diagnosis of rectal adenocarcinoma localised 0 - 12 cm from the anocutaneous line as measured by rigid rectoscopy (i\". Sites: Germany. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04246684","url":"https://clinicaltrials.gov/study/NCT04246684"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04246684","phase":"3","setting":"Short-course Radiotherapy Versus Chemoradiotherapy, Followed by Consolidation Chemotherapy, and Selective Organ Preservation for MRI-defined Intermediate and High-risk Rectal Cancer Patients","sponsor":"Prof. Dr. med. Claus Rödel","started":"2020-11-05","startedType":"actual","enrolled":702,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07581626","kind":"trial","name":"Short-Course Online Adaptive Radiotherapy Combined With Chemotherapy, Targeted Therapy and Immunotherapy as Total Neoadjuvant Therapy (TNT) for Locally Advanced","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Chinese PLA General Hospital, not yet recruiting.","summary":"Short-Course Online Adaptive Radiotherapy Combined With Chemotherapy, Targeted Therapy and Immunotherapy as Total Neoadjuvant Therapy (TNT) for Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT07581626 by Chinese PLA General Hospital, with a registry enrolment figure of 60 participants, started 2026-05-01 and due to reach its primary completion in 2027-04-01. Interventions recorded: SCRT+targeted therapy+immunotherapy+chemotherapy. Conditions listed: Locally Advanced Rectal Cancer (LARC). Primary outcome: Complete Response (CR). Colorectal eligibility wording from the registry: \"* Middle or low rectal cancer located ≤10 cm from the anal verge as assessed by MRI\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07581626","url":"https://clinicaltrials.gov/study/NCT07581626"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07581626","phase":"2","setting":"A Single-Arm, Phase 2 Clinical Study on the Efficacy and Safety of Short-Course Online Adaptive Radiotherapy Combined With Chemotherapy, Targeted Therapy and Immunotherapy as Total Neoadjuvant Therapy (TNT) for Locally Advanced Rectal Cancer","sponsor":"Chinese PLA General Hospital","started":"2026-05-01","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06832917","kind":"trial","name":"Short-course Radiation (SCRT) Followed by 6 Cycles of Cadonilimab Plus MFOLFOX6 As Neoadjuvant Therapy for Patients with Locally Advanced Rectal Cancer (LARC):","aka":["NeoCaCRT-III"],"tldr":"A phase 3 trial in colorectal cancer, run by Wan He, not yet recruiting.","summary":"Short-course Radiation (SCRT) Followed by 6 Cycles of Cadonilimab Plus MFOLFOX6 As Neoadjuvant Therapy for Patients with Locally Advanced Rectal Cancer (LARC): a Multicenter, Two-arm Parallel, Open-label, Randomised Phase III Trial (NeoCaCRT-III) is a phase 3, randomised interventional study registered as NCT06832917 by Wan He, with a registry enrolment figure of 238 participants, started 2025-03-31 and due to reach its primary completion in 2028-12-31. Interventions recorded: AK104 plus; Chemo only. Conditions listed: Rectal Cancer. Primary outcome: 3-year disease free survival (3-y DFS). Colorectal eligibility wording from the registry: \"Histopathology confirmed the diagnosis of rectal adenocarcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06832917","url":"https://clinicaltrials.gov/study/NCT06832917"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06832917","phase":"3","setting":"A Prospective Multicenter, Two-arm Parallel, Open-label, Randomised Phase III Study to Explore the Efficacy and Safety of Cadonilimab Plus Chemotherapy After Short-course Radiotherapy in Locally Advanced Rectal Cancer","sponsor":"Wan He","started":"2025-03-31","startedType":"estimated","enrolled":238,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06455124","kind":"trial","name":"Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)","aka":["TORCH-LE"],"tldr":"A phase 2 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Fudan University, now recruiting.","summary":"Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE) is a phase 2, interventional study registered as NCT06455124 by Fudan University, with a registry enrolment figure of 60 participants, started 2024-05-08 and due to reach its primary completion in 2026-06-30. Interventions recorded: Radiation; PD-1 antibody; Capecitabine; Oxaliplatin. Conditions listed: Rectal Cancer. Primary outcome: 3y LRFS. Colorectal eligibility wording from the registry: \"pT1 after local excision of the primary rectal cancer, with at least one of the high-risk features including margin positivity/very close margin (\\<1mm) at time of local excision, depth of invasion \\>1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06455124","url":"https://clinicaltrials.gov/study/NCT06455124"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06455124","phase":"2","setting":"Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)","sponsor":"Fudan University","started":"2024-05-08","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06462053","kind":"trial","name":"Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer","aka":["TORCH-E2"],"tldr":"A phase 2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) and capecitabine in colorectal cancer, run by Fudan University, now recruiting.","summary":"Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer is a phase 2, randomised interventional study registered as NCT06462053 by Fudan University, with a registry enrolment figure of 134 participants, started 2024-04-01 and due to reach its primary completion in 2026-04-01. Interventions recorded: Short-course radiotherapy; PD-1 antibody (Toripalimab); Long-course radiotherapy; Oxaliplatin; Capecitabine. Conditions listed: Early Low Rectal Cancer. Primary outcome: complete response (CR) rate. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06462053","url":"https://clinicaltrials.gov/study/NCT06462053"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["folfox","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06462053","phase":"2","setting":"A Prospective, Randomized, Phase II Trial of Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer","sponsor":"Fudan University","started":"2024-04-01","startedType":"actual","enrolled":134,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07397442","kind":"trial","name":"Short-Course Radiotherapy Combined With Chemotherapy and Immunotherapy in Mid-Low Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Beijing Friendship Hospital, not yet recruiting.","summary":"Short-Course Radiotherapy Combined With Chemotherapy and Immunotherapy in Mid-Low Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT07397442 by Beijing Friendship Hospital, with a registry enrolment figure of 19 participants, started 2026-03-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: Short-Course Radiotherapy Combined with Chemotherapy and Immunotherapy. Conditions listed: Rectal Cancer, Adenocarcinoma; Rectal Cancer Stage II; Rectal Cancer Stage III. Primary outcome: Complete response rate. Colorectal eligibility wording from the registry: \"Rectal adenocarcinoma confirmed by colonoscopic pathology, with pMMR or MSS\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07397442","url":"https://clinicaltrials.gov/study/NCT07397442"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07397442","phase":"2","setting":"A Prospective, Phase II, Single-Arm Study on the Efficacy and Safety of Neoadjuvant Short-Course Radiotherapy Combined With Chemotherapy and Immunotherapy in Mid-Low Locally Advanced Rectal Cancer","sponsor":"Beijing Friendship Hospital","started":"2026-03-01","startedType":"estimated","enrolled":19,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06014944","kind":"trial","name":"Short-course Radiotherapy Combined With Furoquintinib and PD-1 Monoclonal Antibody","aka":["PMMR/MSS"],"tldr":"A phase 2 trial in colorectal cancer, run by Changhai Hospital, not yet recruiting.","summary":"Short-course Radiotherapy Combined With Furoquintinib and PD-1 Monoclonal Antibody is a phase 2, interventional study registered as NCT06014944 by Changhai Hospital, with a registry enrolment figure of 30 participants, started 2023-09-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody. Conditions listed: Rectal Cancer. Primary outcome: cCR rate. Colorectal eligibility wording from the registry: \"Age 18-75 years old ( including 18 and 75 years old ) ; rectal adenocarcinoma was histologically confirmed as pMMR / MSS type ( according to the detection criteria of the institutional testing center, it can be detected by immunohistochemistry, PCR or NGS ), and was staged as stage II ( T3-4N0 ) or \". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06014944","url":"https://clinicaltrials.gov/study/NCT06014944"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06014944","phase":"2","setting":"A Single-arm, Single-center, Prospective Clinical Study of Short-course Radiotherapy Combined With Furoquintinib and PD-1 Monoclonal Antibody for Neoadjuvant Therapy of PMMR/MSS Type Middle and Low Locally Advanced Rectal Cancer","sponsor":"Changhai Hospital","started":"2023-09-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06872606","kind":"trial","name":"Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for","aka":["SCRIPBOT"],"tldr":"A phase 2 trial of pucotenlimab, bevacizumab (glioblastoma use) and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Sir Run Run Shaw Hospital, not yet recruiting.","summary":"Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Cancer is a phase 2, interventional study registered as NCT06872606 by Sir Run Run Shaw Hospital, with a registry enrolment figure of 33 participants, started 2025-04-01 and due to reach its primary completion in 2026-04-01. Interventions recorded: Pucotenlimab; Bevacizumab; Oxaliplatin; Trifluridine/Tipiracil Hydrochloride; Short-course radiotherapy; intracavitary brachytherapy. Conditions listed: Rectal Adenocarcinoma. Primary outcome: Organ preservation rate. Colorectal eligibility wording from the registry: \"Diagnosed by digital rectal examination, colonoscopy, and high-resolution MRI of the pelvis, the tumor is less than or equal to 5 cm from the anus\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06872606","url":"https://clinicaltrials.gov/study/NCT06872606"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["pucotenlimab","bevacizumab-glioma","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06872606","phase":"2","setting":"The Efficacy and Safety of Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Adenocarcinoma: an Prospective, Single Arm Clinical Trial （SCRIPBOT Trial）","sponsor":"Sir Run Run Shaw Hospital","started":"2025-04-01","startedType":"estimated","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06802666","kind":"trial","name":"Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of ivonescimab, capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, now recruiting.","summary":"Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT06802666 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 45 participants, started 2024-10-16 and due to reach its primary completion in 2026-09-01. Interventions recorded: short-course radiotherapy; Ivonescimab; capecitabine; oxaliplatin; TME surgery. Conditions listed: Locally Advanced Rectal Cancer; Neoadjuvant Therapy. Primary outcome: Pathologic complete response rate (pCR). Colorectal eligibility wording from the registry: \"Histopathologically confirmed locally advanced rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06802666","url":"https://clinicaltrials.gov/study/NCT06802666"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["ivonescimab","capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06802666","phase":"2","setting":"Short-course Radiotherapy(SCRT) Followed by Ivonescimab(AK112) and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer(LARC）: A Single-arm, Single-center, Exploratory, Phase II Clinical Study","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2024-10-16","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06760520","kind":"trial","name":"Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by The First Affiliated Hospital of Zhengzhou University, not yet recruiting.","summary":"Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT06760520 by The First Affiliated Hospital of Zhengzhou University, with a registry enrolment figure of 40 participants, started 2025-01-20 and due to reach its primary completion in 2027-12-20. Interventions recorded: Ivonescimab (SMT112 or AK112) Injection. Conditions listed: Locally Advanced Rectal Cancer. Primary outcome: Complete response rate (CR, pCR plus cCR ). Colorectal eligibility wording from the registry: \"* histologically or cytologically confirmed colorectal adenocarcinoma with non-distant metastasis\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06760520","url":"https://clinicaltrials.gov/study/NCT06760520"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06760520","phase":"2","setting":"A Single-arm, Prospective, Phase II Clinical Study of Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Low-middle Rectal Cancer with a High Risk of Recurrence","sponsor":"The First Affiliated Hospital of Zhengzhou University","started":"2025-01-20","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07686640","kind":"trial","name":"Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in pMMR/MSS Locally Advanced Rectal Cancer","aka":["SCRIT"],"tldr":"A phase 3 trial in colorectal cancer, run by Shandong Cancer Hospital and Institute, now recruiting.","summary":"Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in pMMR/MSS Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT07686640 by Shandong Cancer Hospital and Institute, with a registry enrolment figure of 180 participants, started 2026-08-15 and due to reach its primary completion in 2029-07-15. Interventions recorded: Short-Course Radiotherapy; Consolidation treatment (With ICIs); Consolidation treatment (Without ICIs). Conditions listed: Local Advanced Rectal Cancer; Radiotherapy; Immunotherapy. Primary outcome: Complete Response (CR) Rate. Colorectal eligibility wording from the registry: \"* Patients aged 18-75 years with histologically confirmed pMMR/MSS rectal adenocarcinoma are eligible if they have MRI-defined clinical stage II or III disease according to AJCC 8th edition, tumor located within 12 cm from the anal verge, and at least one high-risk feature, including cT4b, cN2, EMVI\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07686640","url":"https://clinicaltrials.gov/study/NCT07686640"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07686640","phase":"3","setting":"Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in pMMR/MSS Locally Advanced Rectal Cancer (SCRIT): A Multicenter Phase III Randomized Controlled Trial","sponsor":"Shandong Cancer Hospital and Institute","started":"2026-08-15","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05484024","kind":"trial","name":"Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer","aka":["STELLAR II"],"tldr":"A phase 2/3 trial of sintilimab in colorectal cancer, run by Chinese Academy of Medical Sciences, not yet recruiting.","summary":"Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer is a phase 2/3, randomised interventional study registered as NCT05484024 by Chinese Academy of Medical Sciences, with a registry enrolment figure of 588 participants, started 2022-08-06 and due to reach its primary completion in 2028-07-31. Interventions recorded: Sintilimab; Short-course radiotherapy; CAPOX/mFOLFOX. Conditions listed: Rectal Neoplasms Malignant; Radiotherapy. Primary outcome: complete remission; Disease-free survival rate. Colorectal eligibility wording from the registry: \"* Biopsy proven rectal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05484024","url":"https://clinicaltrials.gov/study/NCT05484024"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05484024","phase":"2/3","setting":"Preoperative Short-course Radiotherapy Followed by Chemotherapy With or Without PD-1 Inhibitor for Locally Advanced Rectal Cancer: a Prospective, Multicenter, Randomized Controlled, Phase II/III Study (STELLAR II Study)","sponsor":"Chinese Academy of Medical Sciences","started":"2022-08-06","startedType":"estimated","enrolled":588,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06234007","kind":"trial","name":"Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Mult","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, now recruiting.","summary":"Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study is a phase 2, interventional study registered as NCT06234007 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 45 participants, started 2023-12-01 and due to reach its primary completion in 2024-12-31. Interventions recorded: Fruquintinib, Adebrelimab, Oxaliplatin, Capecitabine. Conditions listed: Locally Advanced Rectal Cancer. Primary outcome: pathology complete response(pCR). Colorectal eligibility wording from the registry: \"Locally advanced rectal adenocarcinoma confirmed by histopathology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06234007","url":"https://clinicaltrials.gov/study/NCT06234007"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06234007","phase":"2","setting":"Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study (UNION PRECISION-I)","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2023-12-01","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07594925","kind":"trial","name":"Short-Course Radiotherapy Followed by Immunotherapy Combined With Chemotherapy for Microsatellite Stable Locally Advanced Rectal Cancer: A Prospective, Randomiz","aka":[],"tldr":"A phase 2 trial of sintilimab in colorectal cancer, run by Tianjin Medical University Cancer Institute and Hospital, now recruiting.","summary":"Short-Course Radiotherapy Followed by Immunotherapy Combined With Chemotherapy for Microsatellite Stable Locally Advanced Rectal Cancer: A Prospective, Randomized, Controlled Phase II Clinical Trial is a phase 2, randomised interventional study registered as NCT07594925 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 130 participants, started 2026-05-01 and due to reach its primary completion in 2029-06-01. Interventions recorded: Sintilimab; Chemotherapy Drugs; radiotherapy. Conditions listed: Rectal Cancer. Primary outcome: DFS. Colorectal eligibility wording from the registry: \"The lower boundary of the lesion is ≤ 10 cm from the anal verge, confirmed by colonoscopy or digital rectal examination;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07594925","url":"https://clinicaltrials.gov/study/NCT07594925"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07594925","phase":"2","setting":"Short-Course Radiotherapy Followed by Immunotherapy Combined With Chemotherapy for Microsatellite Stable Locally Advanced Rectal Cancer: A Prospective, Randomized, Controlled Phase II Clinical Trial","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2026-05-01","startedType":"estimated","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04928807","kind":"trial","name":"Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in Locally Advanced Rectal Cancer (UNION)","aka":["UNION"],"tldr":"A phase 3 trial in colorectal cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, active but no longer recruiting.","summary":"Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in Locally Advanced Rectal Cancer (UNION) is a phase 3, randomised interventional study registered as NCT04928807 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 231 participants, started 2021-07-20 and due to reach its primary completion in 2023-03-01. Interventions recorded: Short course radiotherapy sequential camrelizumab and chemotherapy. Conditions listed: Rectal Cancer. Primary outcome: pathological complete response (pCR) rate. Colorectal eligibility wording from the registry: \"Histologically confirmed T3-44 and/or N+ rectal adenocarcinoma (AJCC/UICC TNM staging (8th Edition, 2017);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04928807","url":"https://clinicaltrials.gov/study/NCT04928807"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04928807","phase":"3","setting":"A Multicenter, Randomized, Open-label, Controlled Phase III Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in the Treatment for Locally Advanced Rectal Cancer","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2021-07-20","startedType":"actual","enrolled":231,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06542588","kind":"trial","name":"Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC","aka":[],"tldr":"A phase 2 trial of serplulimab in colorectal cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, now recruiting.","summary":"Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC is a phase 2, interventional study registered as NCT06542588 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 29 participants, started 2024-07-19 and due to reach its primary completion in 2025-12. Interventions recorded: HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody). Conditions listed: Rectal Cancer. Primary outcome: complete response (CR) rate. Colorectal eligibility wording from the registry: \"Histologically confirmed Locally Advanced rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06542588","url":"https://clinicaltrials.gov/study/NCT06542588"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06542588","phase":"2","setting":"A Multicenter, Single-arm, Open-label Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07 and Serplulimab in the Treatment for RAS/BRAF Wild Type Locally Advanced Rectal Cancer","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2024-07-19","startedType":"actual","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07005570","kind":"trial","name":"Short-course Radiotherapy Followed by Sequential Chemotherapy With or Without PD-1 Monoclonal Antibody and Bevacizumab as Total Neoadjuvant Therapy in pMMR/MSS","aka":[],"tldr":"A phase 2 trial of bevacizumab (glioblastoma use) in colorectal cancer, run by Dechang Diao, now recruiting.","summary":"Short-course Radiotherapy Followed by Sequential Chemotherapy With or Without PD-1 Monoclonal Antibody and Bevacizumab as Total Neoadjuvant Therapy in pMMR/MSS Locally Advanced Rectal Cancer （SPARK） is a phase 2, randomised interventional study registered as NCT07005570 by Dechang Diao, with a registry enrolment figure of 86 participants, started 2025-05-01 and due to reach its primary completion in 2027-07-01. Interventions recorded: Short-course radiotherapy followed by sequential chemotherapy combined with PD-1 monoclonal antibody and bevacizumab; Short-course radiotherapy followed by sequential chemotherapy. Conditions listed: pMMR/MSS Locally Advanced Rectal Cancer. Primary outcome: Complete Response (CR) Rate; Adverse events. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07005570","url":"https://clinicaltrials.gov/study/NCT07005570"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07005570","phase":"2","setting":"Short-Course Radiotherapy Followed by Sequential Chemotherapy Combined With PD-1 Monoclonal Antibody and Bevacizumab Versus Short-Course Radiotherapy Followed by Sequential Chemotherapy as Total Neoadjuvant Therapy in pMMR/MSS Locally Advanced Rectal Cancer","sponsor":"Dechang Diao","started":"2025-05-01","startedType":"actual","enrolled":86,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07448077","kind":"trial","name":"Short-course Radiotherapy in TNT Combined With Enlonstobart for pMMR LARC","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Hebei Medical University Fourth Hospital, now recruiting.","summary":"Short-course Radiotherapy in TNT Combined With Enlonstobart for pMMR LARC is a phase 2, randomised interventional study registered as NCT07448077 by Hebei Medical University Fourth Hospital, with a registry enrolment figure of 128 participants, started 2026-03-01 and due to reach its primary completion in 2026-03-01. Interventions recorded: Experimental: short-course radiotherapy and immunotherapy; Chemoradiotherapy. Conditions listed: Efficacy and Safety of Short-course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer. Primary outcome: complete response Rate (pCR+cCR ). Colorectal eligibility wording from the registry: \"Histologically confirmed adenocarcinoma of the colon, and umor biopsy immunohistochemistry (IHC) indicates pMMR\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07448077","url":"https://clinicaltrials.gov/study/NCT07448077"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07448077","phase":"2","setting":"Short-Course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial","sponsor":"Hebei Medical University Fourth Hospital","started":"2026-03-01","startedType":"actual","enrolled":128,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07394192","kind":"trial","name":"Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-III Rectal Cancer","aka":["PKUCH- R11"],"tldr":"A phase 2 trial in colorectal cancer, run by Peking University Cancer Hospital & Institute, not yet recruiting.","summary":"Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-III Rectal Cancer is a phase 2, interventional study registered as NCT07394192 by Peking University Cancer Hospital & Institute, with a registry enrolment figure of 44 participants, started 2026-02-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: short-course radiotherapy that preserves tumor-draining lymph nodes. Conditions listed: Rectal Cancer; Radiotherapy; PD-1 Inhibitor. Primary outcome: pathologic complete response rate. Colorectal eligibility wording from the registry: \"* Fibrocolonoscopy or digital rectal examination indicates that the distal border of the lesion is located 5-10 cm from the anal verge\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07394192","url":"https://clinicaltrials.gov/study/NCT07394192"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07394192","phase":"2","setting":"Exploratory Study on the Efficacy and Safety of Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-III Rectal Cancer","sponsor":"Peking University Cancer Hospital & Institute","started":"2026-02-01","startedType":"estimated","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07521605","kind":"trial","name":"Short-Course Radiotherapy, Nal-IRI, Capecitabine, and Camrelizumab for Locally Advanced MSS Rectal Cancer","aka":[],"tldr":"A phase 2 trial of irinotecan (and liposomal irinotecan), capecitabine and camrelizumab in colorectal cancer, run by Guangdong Provincial People's Hospital, not yet recruiting.","summary":"Short-Course Radiotherapy, Nal-IRI, Capecitabine, and Camrelizumab for Locally Advanced MSS Rectal Cancer is a phase 2, interventional study registered as NCT07521605 by Guangdong Provincial People's Hospital, with a registry enrolment figure of 44 participants, started 2026-05-20 and due to reach its primary completion in 2031-12-31. Interventions recorded: Short-Course Radiotherapy; Liposomal Irinotecan (nal-IRI); Capecitabine; Camrelizumab. Conditions listed: Rectal Cancer Patients. Primary outcome: Complete Response Rate. Colorectal eligibility wording from the registry: \"Histologically confirmed diagnosis of rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07521605","url":"https://clinicaltrials.gov/study/NCT07521605"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","topoisomerase-inhibitors"],"targets":[],"drugs":["irinotecan","capecitabine","camrelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07521605","phase":"2","setting":"Short-Course Radiotherapy Followed by Liposomal Irinotecan, Capecitabine, and Camrelizumab as Neoadjuvant Therapy for Locally Advanced pMMR/MSS Low Rectal Cancer: A Prospective Single-Arm Phase II Trial Protocol","sponsor":"Guangdong Provincial People's Hospital","started":"2026-05-20","startedType":"estimated","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07651007","kind":"trial","name":"Short-course RT Followed by NALIRIFOX Plus Pucotenlimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS/pMMR","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Wang Xin, not yet recruiting.","summary":"Short-course RT Followed by NALIRIFOX Plus Pucotenlimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS/pMMR is a phase 2, interventional study registered as NCT07651007 by Wang Xin, with a registry enrolment figure of 29 participants, started 2026-05-31 and due to reach its primary completion in 2027-12-31. Interventions recorded: iTNT-HX02. Conditions listed: Advanced Rectal Cancer. Primary outcome: Complete response rate. Colorectal eligibility wording from the registry: \"Pathologically confirmed rectal adenocarcinoma with immunohistochemistry and/or genetic testing showing MSS/pMMR status;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07651007","url":"https://clinicaltrials.gov/study/NCT07651007"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07651007","phase":"2","setting":"A Phase II Clinical Study of Short-course Radiotherapy Followed by NALIRIFOX Plus Pemolivimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS/pMMR","sponsor":"Wang Xin","started":"2026-05-31","startedType":"estimated","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07469306","kind":"trial","name":"Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin), capecitabine and tislelizumab in colorectal cancer, run by Fujian Cancer Hospital, not yet recruiting.","summary":"Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer is a phase 2, randomised interventional study registered as NCT07469306 by Fujian Cancer Hospital, with a registry enrolment figure of 130 participants, started 2026-08-10 and due to reach its primary completion in 2027-08-10. Interventions recorded: Modified Short-course radiotherapy; Long-course radiotherapy; Oxaliplatin; Capecitabine; Tislelizumab; Capecitabine; Tislelizumab. Conditions listed: Locally Advanced Rectal Cancer. Primary outcome: Complete Response (CR) Rate. Colorectal eligibility wording from the registry: \"* Pathologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07469306","url":"https://clinicaltrials.gov/study/NCT07469306"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["folfox","capecitabine","tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07469306","phase":"2","setting":"Prospective, Randomized, Phase II Trial of Modified Short-Course Radiotherapy Plus CAPOX and Tislelizumab Versus Long-Course Chemoradiotherapy Plus Tislelizumab for Locally Advanced Rectal Cancer","sponsor":"Fujian Cancer Hospital","started":"2026-08-10","startedType":"estimated","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06679673","kind":"trial","name":"SHR-1701 Combined with SHR2554 and BP102 for MCRC","aka":[],"tldr":"A phase 2 trial of retlirafusp alfa in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"SHR-1701 Combined with SHR2554 and BP102 for MCRC is a phase 2, interventional study registered as NCT06679673 by Fudan University, with a registry enrolment figure of 20 participants, started 2024-12 and due to reach its primary completion in 2025-12. Interventions recorded: SHR-1701; BP102; SHR2554. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Objective response rate (ORR). Colorectal eligibility wording from the registry: \"* Histological confirmed metastatic colorectal cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06679673","url":"https://clinicaltrials.gov/study/NCT06679673"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["retlirafusp-alfa"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06679673","phase":"2","setting":"An Explorative Study of SHR-1701 Combined with SHR2554 and BP102(bevacizumab) for Metastatic Colorectal Cancer.","sponsor":"Fudan University","started":"2024-12","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05300269","kind":"trial","name":"SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 2 trial of Capecitabine, Oxaliplatin and Retlirafusp alfa in colorectal cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer is a phase 2 interventional study registered as NCT05300269 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 73 participants planned, started 2022-07-05 and due to reach its primary completion in 2024-07-31. Interventions recorded: SHR-1701；Capecitabine；Oxaliplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05300269","url":"https://clinicaltrials.gov/study/NCT05300269"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["capecitabine","oxaliplatin","retlirafusp-alfa"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05300269-cancer-lett-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05300269","phase":"2","setting":"SHR-1701 in Combination With Radiotherapy and Chemotherapy as Perioperative Treatment for Resectable Locally Advanced Rectal Cancer, an Open Label, Single-arm, Multicenter Phase II Trial","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2022-07-05","startedType":"actual","enrolled":73,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07515820","kind":"trial","name":"SHR-3821 in Advanced Colorectal Cancer: an Exploratory Study","aka":[],"tldr":"A phase 2 trial of fruquintinib in colorectal cancer, run by Meng Qiu, not yet recruiting.","summary":"SHR-3821 in Advanced Colorectal Cancer: an Exploratory Study is a phase 2, interventional study registered as NCT07515820 by Meng Qiu, with a registry enrolment figure of 12 participants, started 2026-04-27 and due to reach its primary completion in 2027-07-28. Interventions recorded: SHR-3821 and fruquintinib. Conditions listed: Colorectal Cancer. Primary outcome: Incidence of treatment related adverse event [Safety and Tolerability]; Objective response rate (ORR). Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed unresectable recurrent or metastatic colorectal cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07515820","url":"https://clinicaltrials.gov/study/NCT07515820"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07515820","phase":"2","setting":"SHR-3821 in Advanced Colorectal Cancer: an Exploratory Study","sponsor":"Meng Qiu","started":"2026-04-27","startedType":"estimated","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06373133","kind":"trial","name":"SHR-8068 Combined With Adbelizumab and BP102 in the Treatment of Advanced Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of SHR-8068 and adebrelimab in colorectal cancer, run by West China Hospital, not yet recruiting.","summary":"SHR-8068 Combined With Adbelizumab and BP102 in the Treatment of Advanced Colorectal Cancer is a phase 1/2, interventional study registered as NCT06373133 by West China Hospital, with a registry enrolment figure of 36 participants, started 2024-05-01 and due to reach its primary completion in 2026-11-01. Interventions recorded: SHR-8068; Adebrelimab; BP102. Conditions listed: Colorectal Cancer. Primary outcome: Dose-limiting toxicity; PFS. Colorectal eligibility wording from the registry: \"pathologically confirmed metastatic colorectal adenocarcinoma;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06373133","url":"https://clinicaltrials.gov/study/NCT06373133"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["shr-8068","adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06373133","phase":"1/2","setting":"An Exploratory Clinical Trial of SHR-8068 Combined With Aldebelizumab and BP102 in the Treatment of Refractory Colorectal Cancer","sponsor":"West China Hospital","started":"2024-05-01","startedType":"estimated","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06465563","kind":"trial","name":"SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy as First-line Treatment in Patients With Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of SHR-8068, Adebrelimab, Cisplatin, Gemcitabine and Bevacizumab in biliary tract cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., active and no longer recruiting.","summary":"SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy as First-line Treatment in Patients With Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT06465563 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 93 participants enrolled, started 2024-07-01 and due to reach its primary completion in 2026-12-30. Interventions recorded: SHR-8068, Adebrelimab, Cisplatin, Gemcitabine and Bevacizumab Injection.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06465563","url":"https://clinicaltrials.gov/study/NCT06465563"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["shr-8068","adebrelimab","cisplatin","gemcitabine","bevacizumab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06465563","phase":"2","setting":"SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy for the First-Line Treatment of Advanced Biliary Tract Cancer: A Randomized and Exploratory Cohort, Open-label, Multicenter, Phase II Study","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2024-07-01","startedType":"actual","enrolled":93,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06859775","kind":"trial","name":"SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer","aka":[],"tldr":"A phase 1/2 trial of Trastuzumab rezetecan, Bevacizumab, SHR-8068 in cervical cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., now recruiting.","summary":"SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer is a phase 1/2 interventional study registered as NCT06859775 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 100 participants planned, started 2025-04-25 and due to reach its primary completion in 2026-10. Interventions recorded: SHR-A1811, Adebelimab injection, Bevacizumab injection, SHR-8068, Cisplatin injection. Conditions listed: Recurrent or Metastatic Cervical Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06859775","url":"https://clinicaltrials.gov/study/NCT06859775"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","bevacizumab","shr-8068","cisplatin","carboplatin"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06859775","phase":"1/2","setting":"Open-label, Multicenter Phase Ib/II Clinical Study of Injectable SHR-A1811 in Combination Regimens for the Treatment of Recurrent or Metastatic Cervical Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2025-04-25","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06666166","kind":"trial","name":"SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Yunpeng Liu, not yet recruiting.","summary":"SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer is a phase 2, interventional study registered as NCT06666166 by Yunpeng Liu, with a registry enrolment figure of 28 participants, started 2024-12 and due to reach its primary completion in 2028-07. Interventions recorded: SHR-A1811 & Apartinib. Conditions listed: Advanced Gastric Carcinoma; Advanced Gastroesophageal Junction Adenocarcinoma; Advanced Colorectal Cancer. Primary outcome: Objective response rate (ORR). Colorectal eligibility wording from the registry: \"The function of major organs meets the following criteria(not transfused, not using haematopoietic factors and not corrected with drugs within 14 days):\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06666166","url":"https://clinicaltrials.gov/study/NCT06666166"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06666166","phase":"2","setting":"Exploratory Clinical Study of SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer","sponsor":"Yunpeng Liu","started":"2024-12","startedType":"estimated","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06123494","kind":"trial","name":"SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen","aka":[],"tldr":"A phase 3 trial of Trastuzumab rezetecan, Docetaxel and Ramucirumab in gastric & gastro-oesophageal junction cancer, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen is a phase 3 interventional study registered as NCT06123494 by Jiangsu HengRui Medicine Co., Ltd., with 360 participants planned, started 2024-01-09 and due to reach its primary completion in 2027-06-30. Interventions recorded: SHR-A1811 and Ramucirumab / Paclitaxel/ Docetaxel/ Irinotecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06123494","url":"https://clinicaltrials.gov/study/NCT06123494"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","docetaxel","ramucirumab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06123494","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Open-label Study of SHR-A1811 (HER2-ADC) Compared With the Chemotherapy Treatment Chosen by the Investigators for Subjects With HER2-positive Metastatic and/or Unresectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma Who Have Progressed on or After First-line Anti-HER2 Therapy-containing Regimen","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2024-01-09","startedType":"actual","enrolled":360,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05814354","kind":"trial","name":"SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial","aka":[],"tldr":"A phase 3 trial of Trastuzumab rezetecan, Capecitabine, Eribulin, Gemcitabine and Paclitaxel / nab-paclitaxel in advanced solid tumours, run by Jiangsu HengRui Medicine Co., Ltd., active and no longer recruiting.","summary":"SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial is a phase 3 interventional study registered as NCT05814354 by Jiangsu HengRui Medicine Co., Ltd., with 551 participants enrolled, started 2023-06-30 and due to reach its primary completion in 2026-03-20. Interventions recorded: SHR-A1811 and Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05814354","url":"https://clinicaltrials.gov/study/NCT05814354"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-rezetecan","capecitabine","eribulin","gemcitabine","paclitaxel"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05814354","phase":"3","setting":"A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2023-06-30","startedType":"actual","enrolled":551,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07700719","kind":"trial","name":"SHR-A1904 in Advanced Colorectal Cancer: an Exploratory Study","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Peking University Cancer Hospital & Institute, not yet recruiting.","summary":"SHR-A1904 in Advanced Colorectal Cancer: an Exploratory Study is a phase 2, interventional study registered as NCT07700719 by Peking University Cancer Hospital & Institute, with a registry enrolment figure of 17 participants, started 2026-07-28 and due to reach its primary completion in 2027-11-28. Interventions recorded: SHR-A1904. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Incidence of treatment related adverse event [Safety and Tolerability]; Objective response rate (ORR). Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed metastatic colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07700719","url":"https://clinicaltrials.gov/study/NCT07700719"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07700719","phase":"2","setting":"SHR-A1904 in Advanced Colorectal Cancer: an Exploratory Study","sponsor":"Peking University Cancer Hospital & Institute","started":"2026-07-28","startedType":"estimated","enrolled":17,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06394492","kind":"trial","name":"SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer","aka":[],"tldr":"A phase 3 trial testing SHR-A1921 in ovarian cancer, now recruiting.","summary":"SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer is a phase 3 interventional study registered as NCT06394492, led by Suzhou Suncadia Biopharmaceuticals, and recruiting on the registry. Official title: A Randomised, Open-Label, Controlled, Phase III Study of SHR-A1921 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer. Planned enrolment is 440 participants (estimated). The study started in 2024-05-10 and primary completion is expected in 2026-05-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06394492","url":"https://clinicaltrials.gov/study/NCT06394492"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-a1921"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06394492","phase":"3","setting":"A Randomized, Open-Label, Controlled, Phase III Study of SHR-A1921 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals","started":"2024-05-10","startedType":"actual","enrolled":440,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06819319","kind":"trial","name":"SHR-A2102 Combined With Adebrelimab as Neoadjuvant Therapy for Early Triple-Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of SHR-A2102 and adebrelimab in triple-negative breast cancer, run by Henan Cancer Hospital, not yet recruiting.","summary":"SHR-A2102 Combined With Adebrelimab as Neoadjuvant Therapy for Early Triple-Negative Breast Cancer is a phase 2, interventional study registered as NCT06819319 by Henan Cancer Hospital, with a registry enrolment figure of 52 participants, started 2025-06-23 and due to reach its primary completion in 2026-12-31. Interventions recorded: SHR-A2102 ; Adebrelimab injection. Conditions listed: TNBC - Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Triple-negative PD-L1-positive breast cancer:\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06819319","url":"https://clinicaltrials.gov/study/NCT06819319"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["shr-a2102","adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06819319","phase":"2","setting":"A Phase II Study of SHR-A2102 in Combination With Adebrelimab as Neoadjuvant Therapy for Early Triple-Negative Breast Cancer","sponsor":"Henan Cancer Hospital","started":"2025-06-23","startedType":"estimated","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05020457","kind":"trial","name":"SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC.","aka":[],"tldr":"A phase 2 trial of SI-B001, Cisplatin, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Baili Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. is a phase 2 interventional study registered as NCT05020457 by Sichuan Baili Pharmaceutical Co., Ltd., with 69 participants enrolled, started 2021-12-07 and due to reach its primary completion in 2025-12. Interventions recorded: SI-B001, AP or TP, Docetaxel. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05020457","url":"https://clinicaltrials.gov/study/NCT05020457"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["si-b001","cisplatin","docetaxel"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05020457","phase":"2","setting":"A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in Combination With Chemotherapy in the Treatment of EGFR WT and ALK WT Recurrent and Metastatic Non-small Cell Lung Cancer","sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","started":"2021-12-07","startedType":"actual","enrolled":69,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05020769","kind":"trial","name":"SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2/3 trial testing SI-B001 in non-small-cell lung cancer, active and no longer recruiting.","summary":"SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer is a phase 2/3 interventional study registered as NCT05020769, led by Sichuan Baili Pharmaceutical, and active but no longer recruiting on the registry. Official title: A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in Combination With Osimertinib Mesylate Tablets in the Treatment of Recurrent and Metastatic Non- Small Cell Lung Cancer. Planned enrolment is 14 participants (actual). The study started in 2022-01-06 and primary completion is expected in 2025-12. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05020769","url":"https://clinicaltrials.gov/study/NCT05020769"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["si-b001"],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05020769","phase":"2/3","setting":"A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in Combination With Osimertinib Mesylate Tablets in the Treatment of Recurrent and Metastatic Non- Small Cell Lung Cancer","sponsor":"Sichuan Baili Pharmaceutical","started":"2022-01-06","startedType":"actual","enrolled":14,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07297030","kind":"trial","name":"SIB-RT Combined With CAPOX and PD-1 for High-Risk Rectal Cancer","aka":[],"tldr":"A phase 2 trial of cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"SIB-RT Combined With CAPOX and PD-1 for High-Risk Rectal Cancer is a phase 2, interventional study registered as NCT07297030 by Sun Yat-sen University, with a registry enrolment figure of 37 participants, started 2025-12-20 and due to reach its primary completion in 2026-05-31. Interventions recorded: SIB-SCRT; CAPOX; Immunotherapy. Conditions listed: Rectal Cancer. Primary outcome: The Complete Response (CR) rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed diagnosis of rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07297030","url":"https://clinicaltrials.gov/study/NCT07297030"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07297030","phase":"2","setting":"A Prospective Single-Arm Phase II Clinical Study of Neoadjuvant Short-Course Radiotherapy With Simultaneous Integrated Boost Combined With Capecitabine-Oxaliplatin and PD-1 Inhibitor Therapy in High-Risk Locally Advanced Rectal Cancer","sponsor":"Sun Yat-sen University","started":"2025-12-20","startedType":"estimated","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05303519","kind":"trial","name":"SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)","aka":["SIGMA"],"tldr":"A phase 3 trial testing Safusidenib in glioma & glioblastoma, now recruiting.","summary":"SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance) is a phase 3 interventional study registered as NCT05303519, led by Nuvation Bio with AnHeart Therapeutics, and recruiting on the registry. Official title: A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma. Planned enrolment is 365 participants (estimated). The study started in 2023-06-05 and primary completion is expected in 2028-12-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05303519","url":"https://clinicaltrials.gov/study/NCT05303519"}],"tags":["ctgov-ingest"],"related":[],"cancers":["glioblastoma","idh-mutant-astrocytoma"],"sections":[],"technologies":[],"targets":[],"drugs":["safusidenib"],"companies":["nuvation-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05303519","phase":"3","setting":"A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma","sponsor":"Nuvation Bio","started":"2023-06-05","startedType":"actual","enrolled":365,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03315026","kind":"trial","name":"Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis","aka":[],"tldr":"A phase 2 trial of Siltuximab in Multiple myeloma, run by Memorial Sloan Kettering Cancer Center, active and no longer recruiting.","summary":"Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis is a phase 2 interventional study registered as NCT03315026 by Memorial Sloan Kettering Cancer Center, with 30 participants planned, started 2017-12-14 and due to reach its primary completion in 2026-10. Interventions recorded: Siltuximab, The M.D. Anderson Symptom Inventory (MDASI). Conditions recorded: Multiple Myeloma, AL Amyloidosis.\n\nLinked to the drug Siltuximab because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03315026","url":"https://clinicaltrials.gov/study/NCT03315026"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["siltuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03315026","phase":"2","setting":"Phase II Study of Interleukin 6 Blockade With Siltuximab to Decrease Symptom Burden in Patients Age 60-75 Undergoing Autologous Stem Cell Transplantation for Multiple Myeloma and AL Amyloidosis","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2017-12-14","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07200141","kind":"trial","name":"Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer","aka":["SIB-NCRT"],"tldr":"A phase 2 trial in colorectal cancer, run by Peking Union Medical College Hospital, now recruiting.","summary":"Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer is a phase 2, randomised interventional study registered as NCT07200141 by Peking Union Medical College Hospital, with a registry enrolment figure of 156 participants, started 2025-10-01 and due to reach its primary completion in 2026-12-01. Interventions recorded: GTV 58.75 Gy/25 fractions(Simultaneous Integrated Boost); GTV 50 Gy/25 fractions(Simultaneous Integrated Boost); Concurrent Chemotherapy; Total mesorectal excision (TME) surgery or non-operative management. Conditions listed: Locally Advanced Rectal Adenocarcinoma. Primary outcome: CR. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07200141","url":"https://clinicaltrials.gov/study/NCT07200141"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07200141","phase":"2","setting":"Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer：A Phase 2, Randomized Controlled Study","sponsor":"Peking Union Medical College Hospital","started":"2025-10-01","startedType":"actual","enrolled":156,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05239546","kind":"trial","name":"Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers","aka":["NAIO"],"tldr":"A phase 2 trial of dostarlimab in colorectal cancer, run by University of Iowa, now recruiting.","summary":"Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers is a phase 2, interventional study registered as NCT05239546 by University of Iowa, with a registry enrolment figure of 25 participants, started 2023-03-24 and due to reach its primary completion in 2028-06-30. Interventions recorded: Dostarlimab. Conditions listed: Colon Cancer; dMMR Colorectal Cancer. Primary outcome: Major Clinical Response (MCR) Rate. Colorectal eligibility wording from the registry: \"* Biopsy proven dMMR (by IHC), Stage II or III colon cancer per CT imaging correlation with AJCC 8th edition, 2017, amendable to en block surgical resection as determined by colorectal surgeon\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05239546","url":"https://clinicaltrials.gov/study/NCT05239546"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05239546","phase":"2","setting":"Phase II, Single Arm Study of Neoadjuvant Dostarlimab (TSR-042) in Stage II and III Deficient Mismatch Repair Colon Cancers","sponsor":"University of Iowa","started":"2023-03-24","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06680739","kind":"trial","name":"Single cEll pRofiling PErsistaNce To ImmuNothErapy","aka":["SERPENTINE"],"tldr":"A phase 2 trial of durvalumab and tremelimumab in colorectal cancer, run by Vall d'Hebron Institute of Oncology, now recruiting.","summary":"Single cEll pRofiling PErsistaNce To ImmuNothErapy is a phase 2, interventional study registered as NCT06680739 by Vall d'Hebron Institute of Oncology, with a registry enrolment figure of 60 participants, started 2022-03-01 and due to reach its primary completion in 2032-07-01. Interventions recorded: Durvalumab; Tremelimumab. Conditions listed: Colorectal Cancer; Endometrial Cancer. Primary outcome: Evaluation of Objective Response Rate (ORR). Colorectal eligibility wording from the registry: \", Health Insurance Portability and Accountability Act in the US, European Union \\[EU\\] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations\". Sites: Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06680739","url":"https://clinicaltrials.gov/study/NCT06680739"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06680739","phase":"2","setting":"Single Cell Characterization of Persistent Cells Upon Treatment With Durvalumab (MEDI4736) With or Without Tremelimumab in MSS and MSI Colorectal and Endometrial Tumors: the SERPENTINE Clinical Trial","sponsor":"Vall d'Hebron Institute of Oncology","started":"2022-03-01","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07039526","kind":"trial","name":"Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer","aka":[],"tldr":"A phase 2 trial of Pafolacianine in Oesophageal cancer, run by John Waters, now recruiting.","summary":"Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer is a phase 2 interventional study registered as NCT07039526 by John Waters, with 50 participants planned, started 2025-08-19 and due to reach its primary completion in 2027-12. Interventions recorded: CYTALUX™ (pafolacianine) injection preoperatively. Conditions recorded: Esophageal Cancer, Gastrointestinal Cancers, Gynecologic Cancers.\n\nLinked to the drug Pafolacianine because the registry names it among its interventions and Oesophageal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07039526","url":"https://clinicaltrials.gov/study/NCT07039526"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal"],"sections":[],"technologies":[],"targets":[],"drugs":["pafolacianine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07039526","phase":"2","setting":"Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer.","sponsor":"John Waters","started":"2025-08-19","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07648264","kind":"trial","name":"Single-arm Study of IgPro20 in Adults With Secondary Immune Deficiencies Due to Hematologic Malignancies Treated With B-cell Targeting Chimeric Antigen Receptor T-cell and T-cell Redirecting Therapies","aka":[],"tldr":"A phase 3 trial of IgPro20 in advanced solid tumours, run by CSL Behring, now recruiting.","summary":"Single-arm Study of IgPro20 in Adults With Secondary Immune Deficiencies Due to Hematologic Malignancies Treated With B-cell Targeting Chimeric Antigen Receptor T-cell and T-cell Redirecting Therapies is a phase 3 interventional study registered as NCT07648264 by CSL Behring, with 63 participants planned, started 2026-09-11 and due to reach its primary completion in 2029-03-13. Interventions recorded: IgPro20.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07648264","url":"https://clinicaltrials.gov/study/NCT07648264"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["csl"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07648264","phase":"3","setting":"A Phase 3, Prospective, Open-label, Multicenter, Single-arm Study to Investigate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Subjects With Secondary Immune Deficiency Due to Hematologic Malignancies Treated With B-cell Targeting Chimeric Antigen Receptor T-cell and T-cell Redirecting Therapies","sponsor":"CSL Behring","started":"2026-09-15","startedType":"actual","enrolled":63,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07750951","kind":"trial","name":"Single-arm, Phase II Clinical Study Evaluating the Safety and Efficacy of Sintilimab Combined With IBI-310 and Chemotherapy as Neoadjuvant Therapy for Locally A","aka":["sintilimab"],"tldr":"A phase 2 trial in colorectal cancer, run by Xijing Hospital, now recruiting.","summary":"Single-arm, Phase II Clinical Study Evaluating the Safety and Efficacy of Sintilimab Combined With IBI-310 and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT07750951 by Xijing Hospital, with a registry enrolment figure of 34 participants, started 2026-05-29 and due to reach its primary completion in 2026-11. Interventions recorded: Cindilimab、IBI310、Capecitabine、Oxaliplatin. Conditions listed: MSI-H/dMMR Locally Advanced Rectal Adenocarcinoma. Primary outcome: Pathological complete response (PCR) rate. Colorectal eligibility wording from the registry: \"* 4\\) The primary lesion is a locally advanced rectal adenocarcinoma with histopathologically confirmed MSI-H/dMMR characteristics\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07750951","url":"https://clinicaltrials.gov/study/NCT07750951"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07750951","phase":"2","setting":"Single-arm, Phase II Clinical Study Evaluating the Safety and Efficacy of Sintilimab Combined With IBI-310 and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer","sponsor":"Xijing Hospital","started":"2026-05-29","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00082927","kind":"trial","name":"Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain","aka":[],"tldr":"A phase 3 trial of Ibandronic acid in Metastatic cancer and Prostate cancer, run by Cancer Research UK, completed.","summary":"Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain is a phase 3 interventional study registered as NCT00082927 by Cancer Research UK, with 580 participants recorded, started 2003-04. Interventions recorded: ibandronate sodium. Conditions recorded: Metastatic Cancer, Pain, Prostate Cancer.\n\nLinked to the drug Ibandronic acid because the registry names it among its interventions and Metastatic cancer and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00082927","url":"https://clinicaltrials.gov/study/NCT00082927"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["ibandronic-acid"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00082927","phase":"3","setting":"A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain","sponsor":"Cancer Research UK","started":"2003-04","enrolled":580,"enrolledBasis":"registry","outcomes":[]},{"id":"progesterone-preop-tmh","kind":"trial","name":"Single-injection depot progesterone before breast surgery (Tata Memorial)","aka":[],"tldr":"A single cheap hormone injection before breast surgery did not help every woman, but in those whose cancer had reached the lymph nodes it improved survival at five years, a finding still being tested.","summary":"976 women with operable breast cancer were randomised to a single preoperative injection of depot hydroxyprogesterone or no injection, with a median follow-up of 65 months. Disease-free survival and overall survival were not significantly improved overall, but in node-positive patients 5-year disease-free survival was 65.3% versus 54.7% (hazard ratio 0.72; 95% CI 0.54-0.97; P=0.02) and overall survival 75.7% versus 66.8% (hazard ratio 0.70; 95% CI 0.49-0.99; P=0.04). Badwe and colleagues concluded that a simple, inexpensive intervention deserved confirmation; the same group's later randomised trial of peritumoral lidocaine at surgery (1,583 women) did show a survival gain, keeping the perioperative window a live research theme in India.","status":"mixed","asOf":"2026-09-10","links":[{"label":"Badwe et al., JCO 2011","url":"https://doi.org/10.1200/JCO.2010.33.0738"}],"tags":[],"related":[],"cancers":["breast-hr-positive","tnbc"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":[],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":[],"trials":["lidocaine-peritumoral-tmh"],"people":["badwe-rajendra"],"bottlenecks":["b-generic-repurposing","b-surgery-radiation-innovation"],"keyPapers":["paper-badwe-progesterone-jco-2011"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Operable breast cancer: one intramuscular injection of hydroxyprogesterone 5 to 14 days before surgery vs no injection","sponsor":"Tata Memorial Centre","result":"No overall benefit; node-positive 5-year DFS 65.3% vs 54.7% (HR 0.72) and OS 75.7% vs 66.8% (HR 0.70).","yearReported":2011,"enrolled":976,"enrolledBasis":"registry","outcomes":[{"endpoint":"5-year disease-free survival, node-positive subgroup","unit":"%","arms":[{"name":"Progesterone","value":65.3},{"name":"Control","value":54.7}],"hr":0.72,"ci":[0.54,0.97],"p":"0.02","source":"https://doi.org/10.1200/JCO.2010.33.0738"}]},{"id":"sins-trial","kind":"trial","name":"SINS (surgical excision against imiquimod cream for basal cell carcinoma)","aka":["SINS","Surgery versus Imiquimod for Nodular and Superficial basal cell carcinoma","ISRCTN48755084"],"tldr":"The largest trial of a cream against an operation for the commonest cancer found the cream is worse, and stayed worse at five years. About one person in six treated with the cream still needed something else done, against one in fifty after surgery. It is still a reasonable choice for some people, but it is not equivalent.","summary":"SINS randomised 501 people at twelve United Kingdom centres between 2003 and 2007 to imiquimod 5 per cent cream or to surgical excision with a 4 mm margin, for primary nodular or superficial basal cell carcinoma at low-risk sites. It was designed as a non-inferiority trial with a pre-specified margin of a relative risk of 0.87, and it was pragmatic: the question was whether a cream a person applies at home can replace an operation.\n\nAt three years, 178 of 213 participants in the imiquimod group (84 per cent) were treated successfully against 185 of 188 (98 per cent) after surgery, a relative risk of 0.84 with a 98 per cent confidence interval of 0.78 to 0.91 and p<0.0001. That confidence interval lies below the non-inferiority margin, so imiquimod was shown to be inferior rather than merely not shown to be non-inferior. At five years the figures were 170 of 206 (82.5 per cent) against 173 of 177 (97.7 per cent), a relative risk of 0.84 (0.77 to 0.91, p<0.001).\n\nTwo findings soften the verdict. Patient-assessed cosmetic outcome did not clearly differ between the groups, and most imiquimod failures happened in the first year, so a lesion that has responded early is likely to stay away. The commonest adverse events were itching (211 against 129 participants) and weeping (160 against 81), and twelve people (5 per cent) withdrew from imiquimod because of side effects against four (2 per cent) from surgery.","status":"negative","asOf":"2026-09-25","links":[{"label":"ISRCTN48755084","url":"https://www.isrctn.com/ISRCTN48755084"},{"label":"ClinicalTrials.gov NCT00066872","url":"https://clinicaltrials.gov/study/NCT00066872"},{"label":"Three-year results (Lancet Oncology 2014)","url":"https://doi.org/10.1016/S1470-2045(13)70530-8"},{"label":"Five-year results (Journal of Investigative Dermatology 2017)","url":"https://doi.org/10.1016/j.jid.2016.10.019"},{"label":"Three-year results on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/24332516/"}],"tags":[],"related":[],"cancers":["basal-cell-carcinoma","skin-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["imiquimod"],"companies":[],"institutions":["nottingham-cancer-centre"],"pathways":[],"terms":["topical-and-destructive-treatment-bcc","surgical-margins-keratinocyte-cancer"],"trials":["mal-pdt-imiquimod-fluorouracil-superficial-bcc","scin-trial","mohs-versus-excision-facial-bcc"],"people":["hywel-williams"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN48755084","phase":"3","setting":"Primary nodular or superficial basal cell carcinoma at low-risk sites, excluding morphoeic and recurrent tumours and people with Gorlin syndrome: imiquimod 5 per cent cream once daily for six weeks (superficial) or twelve weeks (nodular) against surgical excision with a 4 mm margin, with clinical success at three years as the primary outcome and a non-inferiority margin of a relative risk of 0.87","sponsor":"University of Nottingham, funded by Cancer Research UK","result":"Clinical success at three years 84 per cent with imiquimod against 98 per cent with surgery (relative risk 0.84, 98 per cent confidence interval 0.78 to 0.91, p<0.0001), and at five years 82.5 against 97.7 per cent; imiquimod was inferior, not non-inferior.","yearReported":2017,"enrolled":501,"enrolledBasis":"randomised","enrolledNote":"501 participants were randomised at 12 United Kingdom centres between June 2003 and February 2007, 254 to imiquimod and 247 to surgery; the trial is registered as ISRCTN48755084 and also as NCT00066872, and neither record carries a final enrolment figure.","outcomes":[{"endpoint":"Clinical success at 3 years","primary":true,"unit":"%","arms":[{"name":"Imiquimod 5 per cent cream","n":213,"value":83.6,"note":"178 of 213 participants"},{"name":"Surgical excision, 4 mm margin","n":188,"value":98.4,"note":"185 of 188 participants"}],"p":"<0.0001","source":"https://doi.org/10.1016/s1470-2045(13)70530-8"},{"endpoint":"Clinical success at 5 years","unit":"%","arms":[{"name":"Imiquimod 5 per cent cream","n":206,"value":82.5,"note":"170 of 206 participants"},{"name":"Surgical excision, 4 mm margin","n":177,"value":97.7,"note":"173 of 177 participants"}],"p":"<0.001","source":"https://doi.org/10.1016/j.jid.2016.10.019"},{"endpoint":"Withdrawal because of adverse events","unit":"%","arms":[{"name":"Imiquimod 5 per cent cream","n":249,"value":5,"note":"12 participants"},{"name":"Surgical excision, 4 mm margin","n":229,"value":2,"note":"4 participants"}],"source":"https://doi.org/10.1016/s1470-2045(13)70530-8"}],"replication":"The Dutch three-arm trial reached the same place from the other side: imiquimod was the best of the non-surgical options for superficial basal cell carcinoma, and still left about one person in five with a tumour at five years."},{"id":"nct06050317","kind":"trial","name":"Sintilimab Combined With Chemotherapy and Radiotherapy in Patients With Inoperable Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Shandong Cancer Hospital and Institute, now recruiting.","summary":"Sintilimab Combined With Chemotherapy and Radiotherapy in Patients With Inoperable Pancreatic Cancer is a phase 2, interventional study registered as NCT06050317 by Shandong Cancer Hospital and Institute, with a registry enrolment figure of 25 participants, started 2023-08-18 and due to reach its primary completion in 2025-08-18. Interventions recorded: Sintilimab Plus mFFN or NALIRIFOX and Radiation. Conditions listed: Pancreas Cancer. Primary outcome: PFS; AE. Pancreatic eligibility wording from the registry: \"* Pathological tissue-confirmed unresectable locally advanced pancreatic cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06050317","url":"https://clinicaltrials.gov/study/NCT06050317"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06050317","phase":"2","setting":"Sintilimab Plus Chemotherapy and Radiotherapy for Patients With Inoperable Pancreatic Cancer: a Single-arm, Exploratory, Phase II Trial","sponsor":"Shandong Cancer Hospital and Institute","started":"2023-08-18","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07654530","kind":"trial","name":"Sintilimab Combined With Ipilimumab (N01) Plus AG as First-line Therapy for uBTC.","aka":["SIAG-BTC"],"tldr":"A phase 2 trial of ipilimumab, sintilimab, gemcitabine and nab-paclitaxel in gallbladder cancer and other biliary tract cancers, run by Tianjin Medical University Cancer Institute and Hospital, active and no longer recruiting.","summary":"Sintilimab Combined With Ipilimumab (N01) Plus AG as First-line Therapy for uBTC. is a phase 2, randomised interventional study registered as NCT07654530 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 107 participants, started 2026-04-24 and due to reach its primary completion in 2028-06-30. Interventions recorded: Sintilimab + Ipilimumab (N01) + AG, Sintilimab Combined with Albumin-bound Paclitaxel and Gemcitabine (AG). Conditions listed: Biliary Tract Cancers (BTC). Gallbladder cancer is named in the registry entry: \"* Histologically or cytologically confirmed locally advanced or metastatic biliary tract malignancies, including intrahepatic cholangiocarcinoma (iCCA), extrahepatic cholangiocarcinoma (eCCA) and gallbladder carcinoma (G\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07654530","url":"https://clinicaltrials.gov/study/NCT07654530"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["ipilimumab","sintilimab","gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07654530","phase":"2","setting":"Sintilimab Combined With Ipilimumab (N01) Plus Albumin-bound Paclitaxel and Gemcitabine (AG) as First-line Therapy for Unresectable Locally Advanced or Metastatic Biliary Tract Malignancies: A Prospective Phase II Clinical Study.","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2026-04-24","startedType":"actual","enrolled":107,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06776757","kind":"trial","name":"Sintilimab in Combination with Cetuximab and Chemotherapy As First-line Treatment for RAS/BRAF Wild-type Advanced Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, now recruiting.","summary":"Sintilimab in Combination with Cetuximab and Chemotherapy As First-line Treatment for RAS/BRAF Wild-type Advanced Colorectal Cancer is a phase 1/2, interventional study registered as NCT06776757 by Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, with a registry enrolment figure of 30 participants, started 2023-12-25 and due to reach its primary completion in 2025-06-25. Interventions recorded: Sintilimab+Cetuximab+Chemotherapy (mFOLFOX6/FOLFIRI/CAPEOX/CAPIRI); Sintilimab+Cetuximab+Chemotherapy (mFOLFOX6/FOLFIRI/CAPEOX/CAPIRI). Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Objective Response Rate (ORR). Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed inoperable or recurrent metastatic colorectal cancer (AJCC 8th edition, Stage IV)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06776757","url":"https://clinicaltrials.gov/study/NCT06776757"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06776757","phase":"1/2","setting":"Sintilimab in Combination with Cetuximab and Chemotherapy As First-line Treatment for RAS/BRAF Wild-type Advanced Colorectal Cancer: an Open-label, Non-comparative, Phase 1b/2 Dose Escalation and Expansion Trial","sponsor":"Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center","started":"2023-12-25","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06973343","kind":"trial","name":"Sintilimab Plus Bevacizumab and Chemotherapy in MSS/pMMR Colorectal With no Liver Metastasis","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Anhui Provincial Cancer Hospital, not yet recruiting.","summary":"Sintilimab Plus Bevacizumab and Chemotherapy in MSS/pMMR Colorectal With no Liver Metastasis is a phase 2, interventional study registered as NCT06973343 by Anhui Provincial Cancer Hospital, with a registry enrolment figure of 20 participants, started 2025-05 and due to reach its primary completion in 2026-02. Interventions recorded: Group A; Group B. Conditions listed: Colorectal Cancer Metastatic. Primary outcome: PFS. Colorectal eligibility wording from the registry: \"Histologically confirmed as colorectal adenocarcinoma without liver metastasis\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06973343","url":"https://clinicaltrials.gov/study/NCT06973343"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06973343","phase":"2","setting":"Sintilimab Plus Bevacizumab and Chemotherapy on Treatment in Patients With Advanced no Liver Metastatic MSS/pMMR Colorectal Cancer: Phase II Cohort Study","sponsor":"Anhui Provincial Cancer Hospital","started":"2025-05","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07656766","kind":"trial","name":"Sintilimab Plus Gossypol Acetate in Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of sintilimab in colorectal cancer, run by Peking University People's Hospital, not yet recruiting.","summary":"Sintilimab Plus Gossypol Acetate in Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT07656766 by Peking University People's Hospital, with a registry enrolment figure of 32 participants, started 2026-07-15 and due to reach its primary completion in 2027-09-15. Interventions recorded: Sintilimab; Gossypol Acetate. Conditions listed: Advanced Colorectal Cancer. Primary outcome: Objective Response Rate. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed advanced colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07656766","url":"https://clinicaltrials.gov/study/NCT07656766"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07656766","phase":"2","setting":"A Single-Arm, Open-Label, Exploratory Phase II Clinical Trial of Sintilimab Plus Gossypol Acetate in Patients With Advanced pMMR/MSS Colorectal Cancer After Failure of at Least Two Prior Lines of Therapy","sponsor":"Peking University People's Hospital","started":"2026-07-15","startedType":"estimated","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07831993","kind":"trial","name":"Sintilimab Plus NALIRIFOX or Gemcitabine-Cisplatin as First-Line Treatment for Metastatic Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of sintilimab, gemcitabine, cisplatin and other drugs in gallbladder cancer and other biliary tract cancers, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, now recruiting.","summary":"Sintilimab Plus NALIRIFOX or Gemcitabine-Cisplatin as First-Line Treatment for Metastatic Biliary Tract Cancer is a phase 2, randomised interventional study registered as NCT07831993 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, with a registry enrolment figure of 54 participants, started 2026-01-14 and due to reach its primary completion in 2027-06-30. Interventions recorded: Sintilimab, Irinotecan Hydrochloride Liposome Injection (II), Oxaliplatin, Leucovorin, Fluorouracil, gemcitabine, Cisplatin. Conditions listed: Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: \"2. Histologically and/or cytologically confirmed biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07831993","url":"https://clinicaltrials.gov/study/NCT07831993"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["sintilimab","gemcitabine","cisplatin","oxaliplatin","fluorouracil","leucovorin","irinotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07831993","phase":"2","setting":"A Randomized, Noncomparative, Open-Label, Exploratory Clinical Study of Sintilimab in Combination With NALIRIFOX (Liposomal Irinotecan [II] Plus 5-Fluorouracil/Leucovorin and Oxaliplatin) or GP (Gemcitabine Plus Cisplatin) as First-Line Treatment for Metastatic Biliary Tract Cancer","sponsor":"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","started":"2026-01-14","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"siopel-3","kind":"trial","name":"SIOPEL-3","aka":["SIOPEL 3","SIOPEL3","SIOP-SIOPEL-3"],"tldr":"SIOPEL-3 showed that children with standard-risk hepatoblastoma can be cured with cisplatin alone before and after surgery, leaving out doxorubicin and its heart damage, because the cure rate was the same as with the two-drug combination.","summary":"SIOPEL-3 was the international liver tumour trial of the SIOP group. Children with standard-risk hepatoblastoma were randomised to cisplatin alone or to cisplatin plus doxorubicin, given as pre-operative chemotherapy with delayed resection and continued after surgery; the primary endpoint was the complete resection rate, with survival and toxicity as secondary endpoints. A separate high-risk stratum received intensified therapy.\n\nComplete resection was achieved in 95 percent of the cisplatin group and 93 percent of the combination group; three-year event-free survival was 83 against 85 percent and overall survival 95 against 93 percent, while grade 3 or 4 acute toxicity was far more frequent with the combination (74.4 against 20.6 percent). Cisplatin monotherapy with delayed resection is the standard for standard-risk hepatoblastoma on the corpus's hepatoblastoma page, with sodium thiosulfate added after each dose to protect hearing following SIOPEL-6.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00003912","url":"https://clinicaltrials.gov/study/NCT00003912"}],"tags":["soc-trials"],"related":[],"cancers":["hepatoblastoma","childhood-cancers"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cisplatin","doxorubicin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-siopel-3-cisplatin-vs-plado-standard-risk-hepatoblastoma-perilongo-nejm-2009"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003912","phase":"3","setting":"Standard-risk hepatoblastoma in children (tumour confined to the liver, no more than three sectors involved, no metastases): pre-operative cisplatin alone against cisplatin plus doxorubicin (PLADO), with delayed resection and post-operative chemotherapy","sponsor":"Societe Internationale d'Oncologie Pediatrique","result":"Complete resection 95 percent with cisplatin alone against 93 percent with cisplatin plus doxorubicin; three-year overall survival 95 against 93 percent; grade 3 or 4 toxicity 20.6 against 74.4 percent.","started":"1998-06","yearReported":2009,"enrolled":255,"enrolledBasis":"randomised","enrolledNote":"The registry gives an estimated 260 for the whole liver tumour programme; the standard-risk randomisation reported in the New England Journal of Medicine randomised 255 children (126 to cisplatin, 129 to cisplatin plus doxorubicin) between 1998 and 2006.","outcomes":[{"endpoint":"Complete resection (intention to treat)","primary":true,"unit":"%","arms":[{"name":"Cisplatin alone","n":126,"value":95},{"name":"Cisplatin + doxorubicin (PLADO)","n":129,"value":93}],"source":"https://doi.org/10.1056/NEJMoa0810613"},{"endpoint":"Event-free survival at 3 years","unit":"%","arms":[{"name":"Cisplatin alone","n":126,"value":83,"note":"95% CI 77 to 90; median follow-up 46 months"},{"name":"Cisplatin + doxorubicin (PLADO)","n":129,"value":85,"note":"95% CI 79 to 92"}],"source":"https://doi.org/10.1056/NEJMoa0810613"},{"endpoint":"Overall survival at 3 years","unit":"%","arms":[{"name":"Cisplatin alone","n":126,"value":95,"note":"95% CI 91 to 99"},{"name":"Cisplatin + doxorubicin (PLADO)","n":129,"value":93,"note":"95% CI 88 to 98"}],"source":"https://doi.org/10.1056/NEJMoa0810613"},{"endpoint":"Acute grade 3 or 4 adverse events","unit":"%","arms":[{"name":"Cisplatin alone","n":126,"value":20.6},{"name":"Cisplatin + doxorubicin (PLADO)","n":129,"value":74.4}],"source":"https://doi.org/10.1056/NEJMoa0810613"}]},{"id":"siopel-4","kind":"trial","name":"SIOPEL-4","aka":["SIOPEL 4","SIOPEL4","SIOP-SIOPEL-4"],"tldr":"SIOPEL-4 showed that giving cisplatin every week in a dense schedule, with doxorubicin, to children with high-risk hepatoblastoma got nearly all of them to respond and three quarters to complete resection, lifting three-year survival to 83 percent in a group that used to do poorly.","summary":"SIOPEL-4 was a prospective single-arm feasibility study of the SIOPEL group in 62 children with high-risk hepatoblastoma, 39 of them with lung metastases. Pre-operative treatment was dose-dense cisplatin (80 mg/m2 then 70 mg/m2 weekly) with doxorubicin over three cycles, followed by removal of all remaining tumour, including liver transplantation and metastasectomy where needed; patients still unresectable had further doxorubicin and carboplatin, and the rest received post-operative carboplatin and doxorubicin. The primary endpoint was complete remission at the end of treatment.\n\n60 of 61 evaluable patients responded to pre-operative chemotherapy, complete resection was achieved in 74 percent and 79 percent were in complete remission at the end of therapy; three-year event-free survival was 76 percent and overall survival 83 percent. Nearly every patient had grade 3 or 4 haematological toxicity and 71 percent had febrile neutropenia. Dose-dense cisplatin is the high-risk regimen on the corpus's hepatoblastoma page.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00077389","url":"https://clinicaltrials.gov/study/NCT00077389"}],"tags":["soc-trials"],"related":[],"cancers":["hepatoblastoma","childhood-cancers"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cisplatin","doxorubicin","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-siopel-4-dose-dense-cisplatin-high-risk-hepatoblastoma-zsiros-lancet-oncol-2013"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00077389","phase":"2","setting":"High-risk hepatoblastoma in children up to 18 (metastases, all liver sectors involved, extrahepatic abdominal disease, major vascular invasion, low alpha-fetoprotein or tumour rupture): dose-dense weekly cisplatin with doxorubicin before surgery, including liver transplantation and metastasectomy where needed, then carboplatin and doxorubicin after surgery","sponsor":"University of Leicester","result":"Complete remission at the end of therapy in 79 percent of 62 high-risk patients; complete resection 74 percent; three-year event-free survival 76 percent and overall survival 83 percent.","started":"2004-01","yearReported":2013,"enrolled":62,"enrolledBasis":"analysed","enrolledNote":"The registry gives an estimated 57 and was never updated; the Lancet Oncology report analysed 62 eligible patients enrolled between 2005 and 2009.","outcomes":[{"endpoint":"Complete remission at the end of treatment","primary":true,"unit":"%","arms":[{"name":"Dose-dense cisplatin with doxorubicin, surgery, then carboplatin and doxorubicin","n":62,"value":79,"note":"95% CI 67 to 88"}],"source":"https://doi.org/10.1016/S1470-2045(13)70272-9"},{"endpoint":"Partial response to pre-operative chemotherapy","unit":"%","arms":[{"name":"Dose-dense cisplatin with doxorubicin","n":61,"value":98,"note":"60 of 61 evaluable; 95% CI 91 to 100"}],"source":"https://doi.org/10.1016/S1470-2045(13)70272-9"},{"endpoint":"Complete resection of all tumour lesions","unit":"%","arms":[{"name":"Dose-dense cisplatin with doxorubicin, surgery","n":62,"value":74}],"source":"https://doi.org/10.1016/S1470-2045(13)70272-9"},{"endpoint":"Event-free survival at 3 years","unit":"%","arms":[{"name":"SIOPEL-4 regimen","n":62,"value":76,"note":"95% CI 65 to 87; median follow-up 52 months"}],"source":"https://doi.org/10.1016/S1470-2045(13)70272-9"},{"endpoint":"Overall survival at 3 years","unit":"%","arms":[{"name":"SIOPEL-4 regimen","n":62,"value":83,"note":"95% CI 73 to 93"}],"source":"https://doi.org/10.1016/S1470-2045(13)70272-9"},{"endpoint":"Febrile neutropenia (at least one episode)","unit":"%","arms":[{"name":"SIOPEL-4 regimen","n":62,"value":71}],"source":"https://doi.org/10.1016/S1470-2045(13)70272-9"}]},{"id":"hr-nbl1","kind":"trial","name":"SIOPEN HR-NBL1","aka":[],"tldr":"Europe's long-running high-risk neuroblastoma trial set busulfan-melphalan as the transplant regimen and showed that adding IL-2 to anti-GD2 therapy added toxicity but not benefit.","summary":"R1: BuMel superior to CEM (3-year EFS 50% vs 38%; Lancet Oncol 2017). R2: dinutuximab beta + IL-2 vs dinutuximab beta alone: 3-year EFS 56% vs 60%, no benefit, more toxicity (Lancet Oncol 2018). R3/R4 explored induction regimens (rapid COJEC vs modified N7; 2025 report). ClinicalTrials.gov lists an estimated 3,300 participants; enrolment opened in 2002.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01704716","url":"https://clinicaltrials.gov/study/NCT01704716"}],"tags":[],"related":[],"cancers":["neuroblastoma","neuroblastoma-high-risk"],"sections":[],"technologies":["autologous-stem-cell-transplant"],"targets":[],"drugs":["dinutuximab","busulfan"],"companies":["cclg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ruth-ladenstein"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01704716","phase":"3","setting":"High-risk neuroblastoma (Europe): multiple randomisations, including busulfan-melphalan vs CEM conditioning and dinutuximab beta ± IL-2","sponsor":"SIOPEN / Children's Cancer and Leukaemia Group","result":"BuMel > CEM (EFS 50% vs 38%); IL-2 adds no benefit to anti-GD2.","started":"2002-02","yearReported":2017,"enrolled":3300,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 3 years (R1 conditioning)","unit":"%","arms":[{"name":"Busulfan-melphalan","n":296,"value":50},{"name":"CEM","n":302,"value":38}],"p":"0.0005","source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30070-0/fulltext"},{"endpoint":"Event-free survival at 3 years (R2 immunotherapy)","unit":"%","arms":[{"name":"Dinutuximab beta + IL-2","n":200,"value":56},{"name":"Dinutuximab beta","n":206,"value":60}],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30578-3/fulltext"}]},{"id":"nct07165886","kind":"trial","name":"Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors","aka":[],"tldr":"A phase 2/3 trial of Everolimus in pancreatic ductal adenocarcinoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., now recruiting.","summary":"Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors is a phase 2/3 interventional study registered as NCT07165886 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., with 298 participants planned, started 2025-08-29 and due to reach its primary completion in 2028-08-29. Interventions recorded: Sirolimus for injection (albumin bound), Octreotide long-acting injection and Everolimus.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07165886","url":"https://clinicaltrials.gov/study/NCT07165886"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["everolimus"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07165886","phase":"2/3","setting":"Phase II/III Study to Evaluate the Safety and Efficacy of Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","started":"2025-08-29","startedType":"actual","enrolled":298,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06957379","kind":"trial","name":"Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Who Have Failed Standard Therapy","aka":[],"tldr":"A phase 2 trial of Exemestane and Fulvestrant in advanced solid tumours, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., active and no longer recruiting.","summary":"Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Who Have Failed Standard Therapy is a phase 2 interventional study registered as NCT06957379 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., with 78 participants enrolled, started 2024-02-29 and due to reach its primary completion in 2025-06. Interventions recorded: Letrozole, Anastrozole, Exemestane, Fulvestrant and Sirolimus for Injection (Albumin-bound).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06957379","url":"https://clinicaltrials.gov/study/NCT06957379"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["exemestane","fulvestrant"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06957379","phase":"2","setting":"A Phase II Clinical Trial of the Safety and Efficacy of Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for the Treatment of HR-positive, HER2-negative Patients With Advanced Breast Cancer Who Have Failed Standard Therapy","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","started":"2024-02-29","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00615602","kind":"trial","name":"Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer","aka":[],"tldr":"A phase 3 trial of Docetaxel, Trastuzumab, Epirubicin, Cyclophosphamide, Fluorouracil, Lenograstim and Pegfilgrastim in Breast cancer, run by Hellenic Oncology Research Group, completed.","summary":"Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer is a phase 3 interventional study registered as NCT00615602 by Hellenic Oncology Research Group, with 489 participants recorded, started 2004-10 and reaching its primary completion in 2012-05. Interventions recorded: Docetaxel, Trastuzumab, Epirubicin, Cyclophosphamide, 5-fluoruracil, Granulocyte-colony stimulating growth factor, Trastuzumab. Conditions recorded: Breast Cancer.\n\nLinked to the drug Lenograstim because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00615602","url":"https://clinicaltrials.gov/study/NCT00615602"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["docetaxel","trastuzumab","epirubicin","cyclophosphamide","fluorouracil","lenograstim","pegfilgrastim"],"companies":["horg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00615602","phase":"3","setting":"A Multicenter Randomized Phase III Study Comparing 6 Versus 12 Months of Trastuzumab in Combination With Dose Dense Docetaxel Following FE75C as Adjuvant Treatment of Women With Axillary Lymph Node Positive Breast Cancer Over-expressing HER2","sponsor":"Hellenic Oncology Research Group","started":"2004-10","enrolled":489,"enrolledBasis":"registry","outcomes":[]},{"id":"sjmb12","kind":"trial","name":"SJMB12","aka":["St. Jude SJMB12"],"tldr":"SJMB12 is the St. Jude trial that first treated medulloblastoma by its molecular type: children with the low-risk WNT form receive a much lower dose of radiotherapy to the brain and spine, those with the SHH form add the targeted drug vismodegib, and the others add two extra chemotherapy drugs; it is still running and the corpus records the design.","summary":"SJMB12 is a non-randomised phase 2 trial at St. Jude Children's Research Hospital and partner centres in which newly diagnosed medulloblastoma is assigned to strata by molecular subgroup (WNT, SHH, group 3 and 4) and clinical risk. Low-risk WNT patients receive craniospinal irradiation of 15 Gy with a reduced boost and four cycles of cyclophosphamide, cisplatin and vincristine; skeletally mature SHH patients add maintenance vismodegib; intermediate- and high-risk non-WNT, non-SHH patients add pemetrexed and gemcitabine. Randomised sub-studies test aerobic training and cognitive remediation. The primary endpoints are progression-free survival at two years in the low-risk WNT, standard-risk SHH and standard-risk group 3 and 4 strata.\n\nThe registry lists 660 participants with a primary completion date of October 2028 and no posted results. The corpus's WNT medulloblastoma page cites SJMB12 for 15 Gy craniospinal radiotherapy alongside the COG ACNS1422 study of 18 Gy.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01878617","url":"https://clinicaltrials.gov/study/NCT01878617"}],"tags":["soc-trials"],"related":[],"cancers":["medulloblastoma-wnt","medulloblastoma-shh","medulloblastoma-group-3-4","medulloblastoma","brain-tumours","childhood-cancers"],"sections":[],"technologies":["imrt-igrt","proton-therapy","cytotoxic-chemotherapy"],"targets":[],"drugs":["cisplatin","cyclophosphamide","vincristine","vismodegib","pemetrexed","gemcitabine"],"companies":["roche-genentech"],"institutions":["st-jude"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01878617","phase":"2","setting":"Newly diagnosed medulloblastoma aged 3 to 39, stratified by molecular subgroup and clinical risk: reduced craniospinal irradiation (15 Gy) for low-risk WNT tumours, vismodegib added for skeletally mature SHH tumours, and pemetrexed and gemcitabine added for intermediate- and high-risk group 3 and 4 tumours, with exercise and cognitive remediation randomisations","sponsor":"St. Jude Children's Research Hospital","started":"2013-06-23","startedType":"actual","enrolled":660,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07459998","kind":"trial","name":"SKB103 for Injection in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SKB103 for injection monotherapy in advanced solid tumours, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"SKB103 for Injection in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07459998 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 277 participants planned, started 2026-04-23 and due to reach its primary completion in 2029-12-31. Interventions recorded: SKB103 for injection monotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07459998","url":"https://clinicaltrials.gov/study/NCT07459998"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07459998","phase":"1/2","setting":"A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB103 for Injection in Participants With Advanced Solid Tumors","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-04-23","startedType":"actual","enrolled":277,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07380386","kind":"trial","name":"SKB105 for Injection in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SKB105 for injection Monotherapy in advanced solid tumours, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"SKB105 for Injection in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07380386 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 256 participants planned, started 2026-03-05 and due to reach its primary completion in 2029-12-31. Interventions recorded: SKB105 for injection Monotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07380386","url":"https://clinicaltrials.gov/study/NCT07380386"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["skb105"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07380386","phase":"1/2","setting":"A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB105 for Injection in Participants With Advanced Solid Tumors","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-03-05","startedType":"actual","enrolled":256,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07586943","kind":"trial","name":"SKB118 Injection in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SKB118 Injection in advanced solid tumours, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"SKB118 Injection in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07586943 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 530 participants planned, started 2026-06-01 and due to reach its primary completion in 2029-12. Interventions recorded: SKB118 Injection and SKB118+SKB264.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07586943","url":"https://clinicaltrials.gov/study/NCT07586943"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07586943","phase":"1/2","setting":"A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB118 Injection in Participants With Advanced Solid Tumors","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-06-01","startedType":"actual","enrolled":530,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05351788","kind":"trial","name":"SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.","aka":[],"tldr":"A phase 2 trial of Sacituzumab tirumotecan, KL-A167, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer. is a phase 2 interventional study registered as NCT05351788 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 110 participants planned, started 2022-05-20 and due to reach its primary completion in 2026-08. Interventions recorded: SKB264, KL-A167, Carboplatin, Cisplatin. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05351788","url":"https://clinicaltrials.gov/study/NCT05351788"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["sacituzumab-tirumotecan","kl-a167","carboplatin","cisplatin"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05351788-nat-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05351788","phase":"2","setting":"A Phase Ⅱ Clinical Study of Combination Therapy of SKB264 in Patients With Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2022-05-20","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05642780","kind":"trial","name":"SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors","aka":[],"tldr":"A phase 2 trial of Pembrolizumab in advanced solid tumours, run by Klus Pharma Inc., active and no longer recruiting.","summary":"SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors is a phase 2 interventional study registered as NCT05642780 by Klus Pharma Inc., with 240 participants enrolled, started 2023-01-17 and due to reach its primary completion in 2027-11-30. Interventions recorded: SKB264 and Pembrolizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05642780","url":"https://clinicaltrials.gov/study/NCT05642780"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["kelun-biotech","myriad-genetics","discovery-life-sciences","clario"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05642780","phase":"2","setting":"A Multicenter, Open-label, Phase 2, Basket Study to Evaluate the Efficacy and Safety of SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors","sponsor":"Klus Pharma Inc.","started":"2023-01-17","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07697586","kind":"trial","name":"SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of SKB264+SKB118 in non-small-cell lung cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT07697586 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 206 participants planned, started 2026-08-07 and due to reach its primary completion in 2028-08. Interventions recorded: SKB264+SKB118.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07697586","url":"https://clinicaltrials.gov/study/NCT07697586"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07697586","phase":"2","setting":"A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-08-07","startedType":"actual","enrolled":206,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05347134","kind":"trial","name":"SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer","aka":[],"tldr":"A phase 3 trial of SKB264 in triple-negative breast cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., active and no longer recruiting.","summary":"SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer is a phase 3 interventional study registered as NCT05347134 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 254 participants enrolled, started 2022-06-10 and due to reach its primary completion in 2023-11-30. Interventions recorded: SKB264.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05347134","url":"https://clinicaltrials.gov/study/NCT05347134"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05347134-nat-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05347134","phase":"3","setting":"A Randomized, Controlled, Open-label, Multi-center Phase III Clinical Trial of SKB264 for Injection Versus Investigator Selected Regimens in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer Who Have Failed Second-line or Above Prior Standard of Care","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2022-06-10","startedType":"actual","enrolled":254,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05631262","kind":"trial","name":"SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors","aka":[],"tldr":"A phase 2 trial of Docetaxel in advanced solid tumours, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., active and no longer recruiting.","summary":"SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors is a phase 2 interventional study registered as NCT05631262 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 321 participants enrolled, started 2022-11-30 and due to reach its primary completion in 2026-12-30. Interventions recorded: SKB264 and Docetaxel.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05631262","url":"https://clinicaltrials.gov/study/NCT05631262"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05631262","phase":"2","setting":"A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2022-11-30","startedType":"actual","enrolled":321,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07700667","kind":"trial","name":"SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma","aka":[],"tldr":"A phase 2 trial of Tislelizumab and Cisplatin in oesophageal cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma is a phase 2 interventional study registered as NCT07700667 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 120 participants planned, started 2026-08-13 and due to reach its primary completion in 2028-12-31. Interventions recorded: SKB500, Tislelizumab, Cisplatin and 5 - FU.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07700667","url":"https://clinicaltrials.gov/study/NCT07700667"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal","oesophageal-squamous-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["tislelizumab","cisplatin"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07700667","phase":"2","setting":"A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-08-13","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07296809","kind":"trial","name":"SKB500 Combinations in Patients With Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of KL-A167, Carboplatin, Etoposide in small-cell lung cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"SKB500 Combinations in Patients With Small Cell Lung Cancer is a phase 2 interventional study registered as NCT07296809 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 80 participants planned, started 2026-01-30 and due to reach its primary completion in 2028-12-31. Interventions recorded: SKB500 Powder for Injection, KL-A167 Injection, Carboplatin Injection, Etoposide Injection. Conditions listed: Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07296809","url":"https://clinicaltrials.gov/study/NCT07296809"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["kl-a167","carboplatin","etoposide"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07296809","phase":"2","setting":"A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Small Cell Lung Cancer","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-01-30","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07545265","kind":"trial","name":"SKB565 for Injection in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SKB565 in advanced solid tumours, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"SKB565 for Injection in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07545265 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 180 participants planned, started 2026-08-31 and due to reach its primary completion in 2029-03. Interventions recorded: SKB565.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07545265","url":"https://clinicaltrials.gov/study/NCT07545265"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07545265","phase":"1/2","setting":"A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB565 for Injection in Participants With Advanced Solid Tumors","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-08-31","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07341737","kind":"trial","name":"SL-28 for Advanced Solid Tumours","aka":[],"tldr":"A phase 1/2 trial of SL-28 in pancreatic ductal adenocarcinoma, non-small-cell lung cancer, oesophageal cancer, gastric & gastro-oesophageal junction cancer, hepatocellular carcinoma and bladder & urothelial cancer, run by Second Life Therapeutics, now recruiting.","summary":"SL-28 for Advanced Solid Tumours is a phase 1/2 interventional study registered as NCT07341737 by Second Life Therapeutics, with 60 participants planned, started 2026-08-14 and due to reach its primary completion in 2027-01-01. Interventions recorded: SL-28.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07341737","url":"https://clinicaltrials.gov/study/NCT07341737"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","nsclc","esophageal","gastric","hcc","urothelial"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07341737","phase":"1/2","setting":"A Phase 1/2, Multicentre, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of SL-28 in Patients With Advanced Solid Tumours","sponsor":"Second Life Therapeutics","started":"2026-08-14","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07748611","kind":"trial","name":"SMAD4 Tailored Neoadjuvant Therapy for the Treatment of Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma, SMART-PANC Trial","aka":["SMART-PANC"],"tldr":"A phase 2 trial of fluorouracil (5-FU), gemcitabine, fOLFIRI (5-FU, leucovorin, irinotecan), fLOT (5-FU, leucovorin, oxaliplatin, docetaxel) and other drugs in pancreatic cancer, run by Northwestern University, not yet recruiting.","summary":"SMAD4 Tailored Neoadjuvant Therapy for the Treatment of Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma, SMART-PANC Trial is a phase 2, interventional study registered as NCT07748611 by Northwestern University, with a registry enrolment figure of 125 participants, started 2027-02-03 and due to reach its primary completion in 2030-02-03. Interventions recorded: Biospecimen Collection; Computed Tomography; Electronic Health Record Review; Fluorouracil; Gemcitabine; Irinotecan; Leucovorin; Magnetic Resonance Imaging; Nab-paclitaxel; Oxaliplatin; Radiation Therapy; Surgical Procedure. Conditions listed: Borderline Resectable Pancreatic Ductal Adenocarcinoma; Resectable Pancreatic Ductal Adenocarcinoma. Primary outcome: Proportion of patients who achieve R0/R1 surgical resection (Cohort A). Pancreatic eligibility wording from the registry: \"* Patients must have histologically confirmed pancreas ductal adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07748611","url":"https://clinicaltrials.gov/study/NCT07748611"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["fluorouracil","gemcitabine","folfiri","flot","nab-paclitaxel","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07748611","phase":"2","setting":"SMART-PANC: SMAD4 Tailored Neoadjuvant Therapy for Pancreatic Cancer, A Phase ll Non-Randomized, Single Center Pilot Study","sponsor":"Northwestern University","started":"2027-02-03","startedType":"estimated","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07155200","kind":"trial","name":"Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)","aka":["SLICK"],"tldr":"A phase 1/2 trial of fOLFIRI (5-FU, leucovorin, irinotecan) in lung cancer, run by Washington University School of Medicine, now recruiting.","summary":"Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial) is a phase 1/2, interventional study registered as NCT07155200 by Washington University School of Medicine, with a registry enrolment figure of 42 participants, started 2025-12-18 and due to reach its primary completion in 2028-07-31. Interventions recorded: Cirtuvivint; Irinotecan. Conditions listed: Small-cell Lung Cancer; Small Cell Lung Carcinoma; Small Cell Lung Cancer. Primary outcome: Recommended Phase II dose (RP2D) (Phase I only); Objective response rate (ORR) per RECIST criteria (Phase II and RP2D only). Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed small cell lung cancer that has progressed on at least one line of prior platinum-based chemotherapy, given with or without anti-PD-(L)1 therapy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07155200","url":"https://clinicaltrials.gov/study/NCT07155200"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07155200","phase":"1/2","setting":"Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)","sponsor":"Washington University School of Medicine","started":"2025-12-18","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07551635","kind":"trial","name":"SMARCA4/2 Inhibitor for POU2F3-Positive SCLC","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Dana-Farber Cancer Institute, not yet recruiting.","summary":"SMARCA4/2 Inhibitor for POU2F3-Positive SCLC is a phase 2, interventional study registered as NCT07551635 by Dana-Farber Cancer Institute, with a registry enrolment figure of 20 participants, started 2026-09-04 and due to reach its primary completion in 2028-01-31. Interventions recorded: FHD-286. Conditions listed: Small Cell Lung Cancer. Primary outcome: Objective Response Rate (ORR). Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed extensive stage SCLC with documented disease progression or recurrence after prior platinum-based therapy with or without checkpoint inhibitor\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07551635","url":"https://clinicaltrials.gov/study/NCT07551635"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["foghorn-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07551635","phase":"2","setting":"A Phase 2 Study of SMARCA4/2 Inhibitor (FHD-286) for POU2F3-Positive Small-Cell Lung Cancer","sponsor":"Dana-Farber Cancer Institute","started":"2026-09-04","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"smile-enktl","kind":"trial","name":"SMILE","aka":["SMILE regimen","SMILE chemotherapy for extranodal NK/T-cell lymphoma"],"tldr":"An asparaginase-based regimen gave a response in four out of five people with an aggressive nasal lymphoma that had always resisted standard chemotherapy, and nearly all of them had dangerously low white cell counts.","summary":"Extranodal natural killer/T-cell lymphoma, nasal type, is driven by Epstein-Barr virus and is concentrated in east Asia and Latin America. Anthracycline-based regimens such as CHOP fail in it, and every regimen that works is built on asparaginase. The explanation usually given is that the tumour expresses P-glycoprotein, a pump that expels anthracyclines but not asparaginase; immunohistochemical expression has been documented (Wang, American Journal of Hematology 2008), but a Korean series found no correlation between P-glycoprotein and chemotherapy resistance (Kim, Leukemia and Lymphoma 2004), so the mechanism is the accepted account rather than a settled one.\n\nThe NK-Cell Tumor Study Group tested SMILE, a five-drug regimen of dexamethasone, methotrexate, ifosfamide, L-asparaginase and etoposide, in 38 eligible patients with newly diagnosed stage IV, relapsed or refractory disease. The first two patients died of infection, after which eligibility was tightened to require a lymphocyte count of 500 per microlitre or more, and no further treatment-related deaths occurred. After two cycles the overall response rate was 79 per cent (90 per cent confidence interval 65 to 89) and the complete response rate 45 per cent. Of the 28 patients who completed the protocol treatment, 19 went on to haematopoietic stem-cell transplantation. One-year overall survival was 55 per cent (95 per cent confidence interval 38 to 69).\n\nGrade 4 neutropenia occurred in 92 per cent and grade 3 or 4 infection in 61 per cent. SMILE is therefore a regimen for a patient who can be supported through profound myelosuppression, and the eligibility amendment is part of the result rather than a footnote to it. The disease has no cancer record of its own in OnCo yet; it is attached here to peripheral T-cell lymphoma.","status":"positive","asOf":"2026-10-01","links":[{"label":"Journal of Clinical Oncology 2011","url":"https://doi.org/10.1200/JCO.2011.35.6287"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["peripheral-t-cell-lymphoma","non-hodgkin-lymphoma"],"sections":["chemotherapy"],"technologies":[],"targets":[],"drugs":["dexamethasone","methotrexate","ifosfamide","asparaginase","etoposide"],"companies":[],"institutions":[],"pathways":[],"terms":["orr","complete-response","autologous-transplant"],"trials":[],"people":[],"bottlenecks":["b-rare-cancers","b-global-access"],"keyPapers":["paper-smile-chemotherapy-nk-t-cell-lymphoma-jco-2011"],"journals":[],"dependsOn":[],"notes":[],"phase":"2","setting":"Newly diagnosed stage IV, relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type: two cycles of dexamethasone, methotrexate, ifosfamide, asparaginase and etoposide","sponsor":"NK-Cell Tumor Study Group","result":"Overall response 79 per cent and complete response 45 per cent after two cycles, one-year overall survival 55 per cent, with grade 4 neutropenia in 92 per cent.","yearReported":2011,"enrolled":38,"enrolledBasis":"analysed","enrolledNote":"No ClinicalTrials.gov record was found for this study when the registry was searched on 1 October 2026; 38 eligible patients were enrolled and analysed in the Journal of Clinical Oncology report.","outcomes":[{"endpoint":"Overall response rate after two cycles","primary":true,"unit":"%","arms":[{"name":"SMILE","n":38,"value":79,"note":"90 per cent confidence interval 65 to 89"}],"source":"https://doi.org/10.1200/JCO.2011.35.6287"},{"endpoint":"Overall survival at 1 year","unit":"%","arms":[{"name":"SMILE","n":38,"value":55,"note":"95 per cent confidence interval 38 to 69"}]}],"replication":"Asparaginase-based regimens have since been compared with each other in Chinese and Korean trials; the principle that anthracyclines fail and asparaginase works has held."},{"id":"nct06526819","kind":"trial","name":"SMP-3124LP in Adults With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SMP3124LP in advanced solid tumours, run by Sumitomo Pharma America, Inc., now recruiting.","summary":"SMP-3124LP in Adults With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06526819 by Sumitomo Pharma America, Inc., with 120 participants planned, started 2024-08-14 and due to reach its primary completion in 2028-12. Interventions recorded: SMP3124LP.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06526819","url":"https://clinicaltrials.gov/study/NCT06526819"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sumitomo-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06526819","phase":"1/2","setting":"An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults With Advanced Solid Tumors","sponsor":"Sumitomo Pharma America, Inc.","started":"2024-08-14","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07391813","kind":"trial","name":"SNB-101 for Treatment of Extensive Stage Small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of SNB-101 in small-cell lung cancer, run by SN BioScience, now recruiting.","summary":"SNB-101 for Treatment of Extensive Stage Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT07391813 by SN BioScience, with 55 participants planned, started 2026-03 and due to reach its primary completion in 2028-12. Interventions recorded: SNB-101.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07391813","url":"https://clinicaltrials.gov/study/NCT07391813"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07391813","phase":"1/2","setting":"A Phase 1b/2, Open-Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of SNB-101, in Extensive Stage Small Cell Lung Cancer.","sponsor":"SN BioScience","started":"2026-03","startedType":"estimated","enrolled":55,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06736704","kind":"trial","name":"SNV4818 in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Fulvestrant and Palbociclib in advanced solid tumours, run by Pikavation Therapeutics, Inc., now recruiting.","summary":"SNV4818 in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06736704 by Pikavation Therapeutics, Inc., with 320 participants planned, started 2025-02-20 and due to reach its primary completion in 2027-04. Interventions recorded: SNV4818, Fulvestrant and Palbociclib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06736704","url":"https://clinicaltrials.gov/study/NCT06736704"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["fulvestrant","palbociclib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06736704","phase":"1/2","setting":"A Phase 1/2, Open-Label Dose Escalation and Expansion Study of SNV4818 as Monotherapy or in Combination With Other Anticancer Agents in Participants With Advanced Solid Tumors","sponsor":"Pikavation Therapeutics, Inc.","started":"2025-02-20","startedType":"actual","enrolled":320,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00716976","kind":"trial","name":"Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy","aka":[],"tldr":"A phase 3 trial of Sodium thiosulfate in Extragonadal germ cell tumour, Hepatocellular carcinoma, Neuroblastoma and Ovarian cancer, run by Children's Oncology Group, completed.","summary":"Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy is a phase 3 interventional study registered as NCT00716976 by Children's Oncology Group, with 131 participants recorded, started 2008-06-23 and reaching its primary completion in 2015-04-09. Interventions recorded: sodium thiosulfate, examination. Conditions recorded: Brain Tumor, Central Nervous System Tumor, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Liver Cancer, Neuroblastoma, Ototoxicity, Ovarian Cancer, Sarcoma.\n\nLinked to the drug Sodium thiosulfate because the registry names it among its interventions and Extragonadal germ cell tumour, Hepatocellular carcinoma, Neuroblastoma and Ovarian cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00716976","url":"https://clinicaltrials.gov/study/NCT00716976"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["extragonadal-germ-cell-tumour","hcc","neuroblastoma","ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["sodium-thiosulfate"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00716976","phase":"3","setting":"A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children","sponsor":"Children's Oncology Group","started":"2008-06-23","startedType":"actual","yearReported":2014,"enrolled":131,"enrolledBasis":"registry","outcomes":[{"endpoint":"Incidence of Hearing Loss","primary":true,"unit":"participants","arms":[{"name":"STS Arm (Sodium Thiosulfate Treatment)","n":49,"value":14,"note":"Figures from the ClinicalTrials.gov results section (first posted 2014-02-26), not from a publication"},{"name":"Observation Arm","n":55,"value":31}],"source":"https://clinicaltrials.gov/study/NCT00716976?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"%","arms":[{"name":"STS Arm (Sodium Thiosulfate Treatment)","n":61,"value":69.6,"note":"95% CI 55.6 to 79.9; Figures from the ClinicalTrials.gov results section (first posted 2014-02-26), not from a publication"},{"name":"Observation Arm","n":64,"value":82,"note":"95% CI 68.4 to 90.1"}],"source":"https://clinicaltrials.gov/study/NCT00716976?tab=results"}]},{"id":"soft-text","kind":"trial","name":"SOFT & TEXT","aka":[],"tldr":"For younger women, shutting down the ovaries and adding an aromatase inhibitor prevents more recurrences than tamoxifen alone, with the largest gains in the highest-risk women.","summary":"Combined 12-13-year analysis: exemestane + OFS improved DFS and distant recurrence-free interval over tamoxifen + OFS (absolute 4-5%) without an OS difference; SOFT 12-year: adding OFS to tamoxifen improved OS in the chemotherapy cohort (HR ~0.79). Basis for OFS in premenopausal women at higher risk.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00066690","url":"https://clinicaltrials.gov/study/NCT00066690"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["exemestane","tamoxifen","goserelin"],"companies":["breast-cancer-trials","etop-ibcsg"],"institutions":[],"pathways":[],"terms":["ovarian-function-suppression"],"trials":[],"people":["prudence-francis"],"bottlenecks":[],"keyPapers":["paper-soft-text-n-engl-j-med-2015","paper-soft-text-j-clin-oncol-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00066690","phase":"3","setting":"Premenopausal HR+ early breast cancer: ovarian function suppression + exemestane vs + tamoxifen vs tamoxifen alone","sponsor":"IBCSG","result":"Exemestane + OFS: DFS and DRFI improved; no OS difference at 12 years.","started":"2003-12-17","startedType":"actual","yearReported":2014,"enrolled":5738,"enrolledBasis":"registry","outcomes":[{"endpoint":"12-year disease-free survival (TEXT+SOFT)","primary":true,"unit":"%","arms":[{"name":"Exemestane + OFS","value":80.5},{"name":"Tamoxifen + OFS","value":75.9}],"hr":0.79,"ci":[0.7,0.9],"source":"https://ascopubs.org/doi/10.1200/JCO.22.01064"}],"replication":"Consistent with the ABCSG-12 and EBCTCG meta-analyses on OFS."},{"id":"soho-01","kind":"trial","name":"SOHO-01","aka":[],"tldr":"SOHO-01 is the study behind the second oral HER2 pill for lung cancer, approved in November 2025.","summary":"SOHO-01, trial NCT05099172 sponsored by Bayer and reported in 2025, is the phase 1/2 study behind sevabertinib, the second oral HER2 inhibitor for lung cancer, which received accelerated approval on 20 November 2025. In previously treated HER2-mutant non-small-cell lung cancer the objective response rate was around 64 percent, higher in patients who had not received HER2-directed therapy, and the cohort treated after platinum chemotherapy responded in more than seventy percent of cases at the 20 mg dose; a first-line supplemental application received priority review in 2026. OnCo links it to HER2 as a target and to sevabertinib, and the result is consistent with zongertinib in Beamion LUNG-1 for oral HER2 inhibition. It is a single-arm study, and whether an oral HER2 inhibitor beats trastuzumab deruxtecan in this population is the open question. Sevabertinib has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT05099172","url":"https://clinicaltrials.gov/study/NCT05099172"},{"label":"Bayer approval release","url":"https://www.bayer.com/en/us/news-stories/hyrnuo"}],"tags":[],"related":[],"cancers":["nsclc","her2-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["her2"],"drugs":["sevabertinib"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-soho-01-n-engl-j-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05099172","phase":"1/2","setting":"HER2-mutant NSCLC, previously treated and treatment-naive: sevabertinib single arm","sponsor":"Bayer","result":"ORR ~64%; accelerated approval Nov 2025.","started":"2021-10-25","startedType":"actual","yearReported":2025,"enrolled":407,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate, HER2-mutant NSCLC after platinum (Cohort D)","primary":true,"unit":"%","arms":[{"name":"Sevabertinib 20 mg","value":70.5}],"source":"https://clinicaltrials.gov/study/NCT05099172"}],"replication":"Single-arm pivotal; consistent with zongertinib (Beamion LUNG-1, ORR 71%) for oral HER2 inhibition."},{"id":"solar-1","kind":"trial","name":"SOLAR-1","aka":[],"tldr":"The first trial to show a PI3K inhibitor helps in breast cancers carrying a PIK3CA mutation, at the cost of high blood sugar and rash.","summary":"SOLAR-1, trial NCT02437318 sponsored by Novartis and reported in 2018, was the first trial to show that a PI3K inhibitor helps in breast cancers carrying a PIK3CA mutation, at the cost of high blood sugar and rash. It randomised 572 women with HR-positive, HER2-negative advanced breast cancer after an aromatase inhibitor to alpelisib or placebo with fulvestrant, met its primary progression-free survival endpoint in the 341 patients with the mutation and showed no benefit without it, while severe hyperglycaemia in about 37 percent limited uptake. OnCo links it to PIK3CA and PI3K-alpha as a target, alpelisib, fulvestrant and Fabrice André. Whether alpelisib keeps a role as selective inhibitors arrive is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02437318","url":"https://clinicaltrials.gov/study/NCT02437318"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":["pik3ca"],"drugs":["alpelisib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["fabrice-andre"],"bottlenecks":[],"keyPapers":["paper-solar-1-alpelisib-nejm-2019","paper-solar-1-ann-oncol-2021-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02437318","phase":"3","setting":"HR+/HER2- advanced breast cancer after aromatase inhibitor: alpelisib + fulvestrant vs placebo + fulvestrant, by PIK3CA status","sponsor":"Novartis","result":"PFS 11.0 vs 5.7 months, HR 0.65 (PIK3CA-mutant).","started":"2015-07-23","startedType":"actual","yearReported":2018,"enrolled":572,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (PIK3CA-mutant)","primary":true,"unit":"months","arms":[{"name":"Alpelisib + fulvestrant","n":169,"value":11},{"name":"Placebo + fulvestrant","n":172,"value":5.7}],"hr":0.65,"ci":[0.5,0.85],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1813904"}],"replication":"Activity after CDK4/6 inhibitors confirmed in the single-arm BYLieve study; the mutant-selective successor inavolisib (INAVO120) showed a larger effect with less hyperglycaemia."},{"id":"solo-1","kind":"trial","name":"SOLO-1","aka":[],"tldr":"Two years of an olaparib pill after chemotherapy made a large share of women with BRCA-mutated ovarian cancer long-term survivors.","summary":"PFS HR 0.30 at the primary analysis (NEJM 2018). At 7 years, 67.0% of olaparib patients were alive versus 46.5% on placebo (HR 0.55; JCO 2023), the first PARP inhibitor trial with a clinically meaningful overall survival gain in the first-line setting and the basis for the 2018 maintenance approval. Roughly half of olaparib patients remained progression-free at 5 years.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01844986","url":"https://clinicaltrials.gov/study/NCT01844986"},{"label":"NEJM 2018","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1810858"},{"label":"7-year OS, JCO 2023","url":"https://ascopubs.org/doi/10.1200/JCO.22.01549"}],"tags":[],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":["brca","parp"],"drugs":["olaparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["kathleen-moore"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01844986","phase":"3","setting":"Newly diagnosed advanced BRCA-mutated ovarian cancer in response to platinum chemotherapy: olaparib maintenance for 2 years vs placebo","sponsor":"AstraZeneca / Merck","result":"PFS HR 0.30; 7-year OS 67.0% vs 46.5% (HR 0.55).","started":"2013-08-26","startedType":"actual","yearReported":2018,"enrolled":391,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 450 participants (actual); the NEJM 2018 primary analysis randomised 391 patients (260 olaparib, 131 placebo).","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"HR","arms":[{"name":"Olaparib","n":260},{"name":"Placebo","n":131}],"hr":0.3,"ci":[0.23,0.41],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1810858"},{"endpoint":"Overall survival at 7 years","unit":"%","arms":[{"name":"Olaparib","value":67},{"name":"Placebo","value":46.5}],"hr":0.55,"ci":[0.4,0.76],"source":"https://ascopubs.org/doi/10.1200/JCO.22.01549"}],"replication":"PRIMA (niraparib) and PAOLA-1 (olaparib + bevacizumab) reproduced the PFS effect in HRD-positive disease; only SOLO-1 has shown a clear OS gain."},{"id":"nct07431281","kind":"trial","name":"Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2","aka":["CLARITY-Gastric 02"],"tldr":"A phase 3 trial of Sonesitatug vedotin, Rilvegostomig, Nivolumab, Capecitabine, Oxaliplatin and Zolbetuximab in gastric & gastro-oesophageal junction cancer and oesophageal cancer, run by AstraZeneca, now recruiting.","summary":"Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2 is a phase 3 interventional study registered as NCT07431281 by AstraZeneca, with 2130 participants planned, started 2026-02-03 and due to reach its primary completion in 2029-08-16. Interventions recorded: Sonesitatug vedotin, Rilvegostomig, Nivolumab, Capecitabine, 5-Fluorouracil and Oxaliplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07431281","url":"https://clinicaltrials.gov/study/NCT07431281"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","esophageal","oesophageal-adenocarcinoma","gastric-cldn18-2-positive"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy"],"targets":[],"drugs":["cmg901","rilvegostomig","nivolumab","capecitabine","oxaliplatin","zolbetuximab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07431281","phase":"3","setting":"A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)","sponsor":"AstraZeneca","started":"2026-02-03","startedType":"actual","enrolled":2130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05902169","kind":"trial","name":"Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM","aka":["SONOBIRD"],"tldr":"A phase 3 trial of Carboplatin and Temozolomide in glioma & glioblastoma, run by CarThera, now recruiting.","summary":"Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM is a phase 3 interventional study registered as NCT05902169 by CarThera, with 560 participants planned, started 2024-01-29 and due to reach its primary completion in 2028-01-28. Interventions recorded: SonoCloud-9 (SC9), Carboplatin, Lomustine and Temozolomide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05902169","url":"https://clinicaltrials.gov/study/NCT05902169"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","transcranial-focused-ultrasound-systems"],"targets":[],"drugs":["carboplatin","temozolomide"],"companies":["carthera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05902169","phase":"3","setting":"A Randomized, Open-label, Multicentric, Two-arm Pivotal Trial of SonoCloud-9 Combined With Carboplatin (CBDCA) vs Standard of Care Lomustine (CCNU) or Temozolomide (TMZ) in Patients Undergoing Planned Resection for First Recurrence Glioblastoma.","sponsor":"CarThera","started":"2024-01-29","startedType":"actual","enrolled":560,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06561048","kind":"trial","name":"Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma","aka":[],"tldr":"A phase 3 trial testing Soquelitinib in peripheral T-cell lymphomas, now recruiting.","summary":"Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma is a phase 3 interventional study registered as NCT06561048, led by Corvus Pharmaceuticals, and recruiting on the registry. Official title: A Phase 3, Randomised, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physician's Choice Standard of Care Treatment (Selected Single Agent) in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma. Planned enrolment is 150 participants (estimated). The study started in 2024-10-02 and primary completion is expected in 2027-11. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06561048","url":"https://clinicaltrials.gov/study/NCT06561048"}],"tags":["ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["soquelitinib"],"companies":["corvus-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06561048","phase":"3","setting":"A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physician's Choice Standard of Care Treatment (Selected Single Agent) in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma","sponsor":"Corvus Pharmaceuticals","started":"2024-10-02","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"soraya","kind":"trial","name":"SORAYA","aka":[],"tldr":"SORAYA showed that mirvetuximab soravtansine, an antibody-drug conjugate aimed at the folate receptor, shrank about a third of platinum-resistant ovarian cancers that had already been treated with bevacizumab, and earned the first approval of a biomarker-directed drug for this setting.","summary":"Platinum-resistant ovarian cancer responds to single-agent chemotherapy in roughly one patient in ten. SORAYA was a single-arm pivotal study of mirvetuximab soravtansine, an antibody against folate receptor alpha carrying a maytansinoid payload, in 106 patients with platinum-resistant high-grade serous ovarian cancer whose tumours had high folate receptor alpha expression and who had received one to three prior lines including bevacizumab. The primary endpoint was objective response rate by investigator.\n\nAbout a third of patients responded, with responses lasting several months and a toxicity profile dominated by reversible ocular events, which require eye examinations and steroid drops. The drug received accelerated approval in the United States in November 2022, and the randomised MIRASOL trial then confirmed a survival benefit over chemotherapy.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04296890","url":"https://clinicaltrials.gov/study/NCT04296890"}],"tags":["subtype-trials"],"related":[],"cancers":["platinum-resistant-ovarian-cancer","high-grade-serous-ovarian-cancer","ovarian"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["mirvetuximab-soravtansine"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ursula-matulonis"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04296890","phase":"3","setting":"Platinum-resistant high-grade serous ovarian cancer with high folate receptor alpha expression after one to three prior regimens including bevacizumab: single-arm mirvetuximab soravtansine","sponsor":"ImmunoGen (AbbVie)","result":"Objective responses in about a third of patients with folate receptor alpha-high platinum-resistant ovarian cancer; accelerated approval in November 2022.","started":"2020-07-23","startedType":"actual","yearReported":2022,"enrolled":106,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Mirvetuximab soravtansine 6 mg/kg","n":105,"value":32.4,"note":"95% CI 23.6 to 42.2; efficacy-evaluable population"}],"source":"https://doi.org/10.1136/ijgc-2024-005401"},{"endpoint":"Overall survival (final analysis)","unit":"months","arms":[{"name":"Mirvetuximab soravtansine 6 mg/kg","n":105,"value":15,"note":"95% CI 11.5 to 18.7"}],"source":"https://doi.org/10.1136/ijgc-2024-005401"}]},{"id":"nct06225843","kind":"trial","name":"Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis","aka":["EGIA-003"],"tldr":"A phase 2 trial of FOLFOX in colorectal cancer, run by Alethia Biotherapeutics, now recruiting.","summary":"Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis is a phase 2 interventional study registered as NCT06225843 by Alethia Biotherapeutics, with 17 participants planned, started 2024-02-15 and due to reach its primary completion in 2026-03. Interventions recorded: Sotevtamab, FOLFOX. Conditions listed: Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06225843","url":"https://clinicaltrials.gov/study/NCT06225843"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["folfox","sotevtamab"],"companies":["alethia-biotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06225843","phase":"2","setting":"A Proof-of-Concept Phase II Trial to Evaluate the EMT Inhibitor Sotevtamab Combined With FOLFOX Administered as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis","sponsor":"Alethia Biotherapeutics","started":"2024-02-15","startedType":"actual","enrolled":17,"enrolledBasis":"registry","outcomes":[]},{"id":"sound","kind":"trial","name":"SOUND (Sentinel Node vs Observation After Axillary Ultra-Sound)","aka":["SOUND trial"],"tldr":"SOUND went one step further than every trial before it and asked whether the armpit needs to be operated on at all when the tumour is small and the scan is clear. For those women it does not: almost everyone was free of distant spread at five years either way.","summary":"SOUND randomised 1,463 women of any age in Italy, Switzerland, Spain and Chile between 2012 and 2017 who had a breast cancer of up to 2 cm and a negative preoperative axillary ultrasound, to sentinel node biopsy or to no axillary surgery. 1,405 were analysed by intention to treat. The median tumour was 1.1 cm and 87.8 percent were oestrogen receptor-positive and HER2-negative. In the sentinel node arm, 97 patients (13.7 percent) turned out to have positive nodes, which is the size of the staging information the other arm gave up.\n\nAt a median 5.7 years, five-year distant disease-free survival was 97.7 percent with sentinel node biopsy and 98.0 percent without axillary surgery (log-rank p=0.67, hazard ratio 0.84, 90 percent confidence interval 0.45 to 1.54, non-inferiority p=0.02). Locoregional relapses were 12 (1.7 percent) against 11 (1.6 percent), distant metastases 13 against 14, and deaths 21 (3.0 percent) against 18 (2.6 percent).\n\nThe trial attaches a condition that is often dropped when it is quoted: patients can be spared axillary surgery whenever the lack of pathological nodal information does not change the postoperative treatment plan. Where nodal status would decide chemotherapy, radiotherapy fields or the choice of endocrine agent, the information still has to come from somewhere.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02167490","url":"https://clinicaltrials.gov/study/NCT02167490"},{"label":"SOUND (JAMA Oncology 2023)","url":"https://doi.org/10.1001/jamaoncol.2023.3759"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["sentinel-node"],"targets":[],"drugs":[],"companies":[],"institutions":["ieo-milan"],"pathways":[],"terms":["sentinel-lymph-node-biopsy","axillary-surgery-de-escalation","breast-cancer-related-lymphoedema"],"trials":["insema","nsabp-b32"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02167490","phase":"3","setting":"Breast cancer up to 2 cm with a negative preoperative axillary ultrasound: sentinel node biopsy against no axillary surgery at all, with five-year distant disease-free survival as the primary endpoint and a non-inferiority design","sponsor":"European Institute of Oncology, Milan","result":"Five-year distant disease-free survival 98.0 percent without axillary surgery against 97.7 percent with sentinel node biopsy (hazard ratio 0.84, non-inferiority p=0.02).","started":"2012-01","startedType":"actual","yearReported":2023,"enrolled":1463,"enrolledBasis":"randomised","enrolledNote":"1,463 women were randomised and 1,405 were analysed by intention to treat; the ClinicalTrials.gov record NCT02167490 gives an estimated 1,560.","outcomes":[{"endpoint":"Distant disease-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"No axillary surgery","n":697,"value":98},{"name":"Sentinel lymph node biopsy","n":708,"value":97.7}],"hr":0.84,"ci":[0.45,1.54],"p":"0.02 for non-inferiority","source":"https://doi.org/10.1001/jamaoncol.2023.3759"}],"replication":"INSEMA reached the same conclusion in 4,858 patients with T1 and T2 tumours and a longer median follow-up of 73.6 months."},{"id":"nct03448549","kind":"trial","name":"SOX Versus XELOX as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients","aka":[],"tldr":"A phase 3 trial of Oxaliplatin, Tegafur, gimeracil and oteracil and Capecitabine in Colorectal cancer, run by Peking University Cancer Hospital & Institute, with a status the registry has not verified recently.","summary":"SOX Versus XELOX as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients is a phase 3 interventional study registered as NCT03448549 by Peking University Cancer Hospital & Institute, with 1191 participants planned, started 2018-01-01 and due to reach its primary completion in 2021-01-01. Interventions recorded: Oxaliplatin, Tegafur，gimeracil and oteracil potassium, Xeloda. Conditions recorded: Colorectal Cancer Stage III, Adjuvant Chemotherapy.\n\nLinked to the drug Tegafur, gimeracil and oteracil because the registry names it among its interventions and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03448549","url":"https://clinicaltrials.gov/study/NCT03448549"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["oxaliplatin","tegafur-gimeracil-oteracil","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03448549","phase":"3","setting":"A Prospective Randomized Controlled Trial to Compare Oxaliplatin Combined With S-1 (SOX) Versus Oxaliplatin With Capecitabine (XELOX) as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients","sponsor":"Peking University Cancer Hospital & Institute","started":"2018-01-01","startedType":"actual","enrolled":1191,"enrolledBasis":"registry","outcomes":[]},{"id":"spcg-4","kind":"trial","name":"SPCG-4 (Scandinavian Prostate Cancer Group Study 4)","aka":["SPCG-4","Scandinavian Prostate Cancer Group Study Number 4","SPCG-4/SFUO-1"],"tldr":"The trial that proved an operation for prostate cancer can save a life, in men whose cancer was found because of symptoms rather than a blood test, and that the average gain is about three years.","summary":"SPCG-4 randomised 695 men with clinically detected localised prostate cancer to radical prostatectomy or watchful waiting between October 1989 and February 1999, and followed them to the end of 2017. These were not screen-detected cancers: most were found because the man had symptoms or an abnormal examination, so the trial says nothing directly about the tumours a PSA test finds.\n\nBy 31 December 2017, 261 of 347 men in the prostatectomy group and 292 of 348 in the watchful-waiting group had died. Seventy-one deaths in the prostatectomy group and 110 in the watchful-waiting group were from prostate cancer: relative risk 0.55 (95 percent confidence interval 0.41 to 0.74, p<0.001), an absolute difference of 11.7 percentage points (5.2 to 18.2). The number needed to treat to avert one death from any cause was 8.4. At 23 years, a mean of 2.9 extra years of life had been gained with surgery.\n\nThe trial also produced the two pathological features that still drive counselling after an operation: extracapsular extension carried a risk of death from prostate cancer five times that of men without it, and a Gleason score above 7 carried a risk ten times that of a score of 6 or lower.\n\nSPCG-4 and PIVOT are usually read as contradicting each other. They do not: SPCG-4 treated clinically detected cancers in the pre-PSA era and found a benefit, PIVOT treated mostly PSA-detected cancers and did not. The lesson is that the benefit of surgery depends entirely on how the cancer was found.","status":"positive","asOf":"2026-09-25","links":[{"label":"SPCG-4 at 29 years (New England Journal of Medicine 2018)","url":"https://doi.org/10.1056/NEJMoa1807801"}],"tags":[],"related":[],"cancers":["prostate","prostate-low-risk","prostate-intermediate-risk","prostate-high-risk"],"sections":[],"technologies":["robotic-surgery"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["prostatectomy","active-surveillance-term","curative-intent","gleason-grade-group"],"trials":["pivot","protect"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Clinically detected, not screen-detected, localised prostate cancer in men mostly under 75: radical prostatectomy versus watchful waiting, with death from prostate cancer, death from any cause and metastasis as the outcomes, followed to 29 years","sponsor":"Scandinavian Prostate Cancer Group, funded by the Swedish Cancer Society","result":"Prostate cancer deaths 71 of 347 with surgery against 110 of 348 with watchful waiting (relative risk 0.55, 95 percent confidence interval 0.41 to 0.74); number needed to treat 8.4 to avert one death from any cause; mean 2.9 years of life gained at 23 years.","yearReported":2018,"enrolled":695,"enrolledBasis":"randomised","enrolledNote":"695 men were randomised between October 1989 and February 1999; the trial predates ClinicalTrials.gov registration, so there is no registry enrolment figure.","outcomes":[{"endpoint":"Death from prostate cancer at 29 years","primary":true,"unit":"men","arms":[{"name":"Radical prostatectomy","n":347,"value":71,"note":"Relative risk 0.55 (95 percent confidence interval 0.41 to 0.74); absolute difference 11.7 percentage points."},{"name":"Watchful waiting","n":348,"value":110}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1807801"},{"endpoint":"Death from any cause at 29 years","unit":"men","arms":[{"name":"Radical prostatectomy","n":347,"value":261,"note":"Number needed to treat 8.4."},{"name":"Watchful waiting","n":348,"value":292}],"source":"https://doi.org/10.1056/NEJMoa1807801"}],"replication":"Not replicated in a screen-detected population: PIVOT (mostly PSA-detected, 731 men) found no significant mortality difference, and ProtecT (screen-detected, 1,643 men) found prostate cancer mortality under 3 percent in every arm at 15 years."},{"id":"spcg-7","kind":"trial","name":"SPCG-7/SFUO-3","aka":["SPCG-7","SPCG-7/SFUO-3"],"tldr":"Adding radiotherapy to hormone therapy for locally advanced prostate cancer halves the chance of dying of it, and the side effects are modest.","summary":"SPCG-7 asked the mirror image of EORTC 22863: not whether to add hormones to radiotherapy, but whether to add radiotherapy to hormones. It randomised 875 men with locally advanced prostate cancer (T3 in 78 percent, PSA below 70, N0 M0) to endocrine treatment alone (439) or the same endocrine treatment with local radiotherapy (436).\n\nAt a median 7.6 years, 79 men in the endocrine-alone group and 37 in the combined group had died of prostate cancer. Cumulative 10-year prostate cancer mortality was 23.9 percent with endocrine treatment alone and 11.9 percent with the combination, a difference of 12.0 percentage points (95 percent confidence interval 4.9 to 19.1) and a relative risk of 0.44 (0.30 to 0.66). Ten-year overall mortality was 39.4 against 29.6 percent, a difference of 9.8 points (0.8 to 18.8), relative risk 0.68 (0.52 to 0.89). Cumulative 10-year PSA recurrence was 74.7 against 25.9 percent (p<0.0001, hazard ratio 0.16, 0.12 to 0.20).\n\nAfter 5 years, urinary, rectal and sexual problems were slightly more frequent in the combined group. The authors concluded that endocrine treatment plus radiotherapy should be the new standard, and it is.","status":"positive","asOf":"2026-09-25","links":[{"label":"ISRCTN registry ISRCTN01534787","url":"https://www.isrctn.com/ISRCTN01534787"},{"label":"SPCG-7/SFUO-3 (Lancet 2009)","url":"https://doi.org/10.1016/S0140-6736(08)61815-2"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation","imrt-igrt"],"targets":[],"drugs":["flutamide"],"companies":[],"institutions":[],"pathways":[],"terms":["adt","curative-intent","hormone-therapy"],"trials":["nct00002633","eortc-22863"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN01534787","phase":"3","setting":"Locally advanced prostate cancer, 78 percent T3, PSA below 70, N0 M0: endocrine treatment alone, being 3 months of total androgen blockade then continuous flutamide, against the same endocrine treatment with local radiotherapy, with prostate cancer specific survival as the primary endpoint","sponsor":"Scandinavian Prostate Cancer Group and the Swedish Association for Urological Oncology","result":"Ten-year prostate cancer mortality 11.9 percent with hormones plus radiotherapy against 23.9 percent with hormones alone (relative risk 0.44, 95 percent confidence interval 0.30 to 0.66); overall mortality 29.6 against 39.4 percent (0.68, 0.52 to 0.89).","yearReported":2009,"enrolled":875,"enrolledBasis":"randomised","enrolledNote":"875 men from 47 centres in Norway, Sweden and Denmark were randomised; the trial is registered as ISRCTN01534787, not on ClinicalTrials.gov.","outcomes":[{"endpoint":"Prostate cancer mortality at 10 years","primary":true,"unit":"%","arms":[{"name":"Endocrine treatment with radiotherapy","n":436,"value":11.9,"note":"Relative risk 0.44 (95 percent confidence interval 0.30 to 0.66)."},{"name":"Endocrine treatment alone","n":439,"value":23.9}],"source":"https://doi.org/10.1016/S0140-6736(08)61815-2"},{"endpoint":"Overall mortality at 10 years","unit":"%","arms":[{"name":"Endocrine treatment with radiotherapy","n":436,"value":29.6,"note":"Relative risk 0.68 (95 percent confidence interval 0.52 to 0.89)."},{"name":"Endocrine treatment alone","n":439,"value":39.4}],"source":"https://doi.org/10.1016/S0140-6736(08)61815-2"}],"replication":"The NCIC CTG PR.3/MRC PR07 intergroup trial (1,205 men) found the same, with an overall survival hazard ratio of 0.70 at a median 8 years."},{"id":"nct04044768","kind":"trial","name":"Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma","aka":[],"tldr":"A phase 2 trial of Afamitresgene autoleucel in sarcomas, run by USWM CT, LLC, active and no longer recruiting.","summary":"Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma is a phase 2 interventional study registered as NCT04044768 by USWM CT, LLC, with 52 participants enrolled, started 2019-08-13 and due to reach its primary completion in 2021-08-29. Interventions recorded: afamitresgene autoleucel (previously ADP-A2M4). Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04044768","url":"https://clinicaltrials.gov/study/NCT04044768"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma","liposarcoma","synovial-sarcoma"],"sections":[],"technologies":["tcr-t"],"targets":[],"drugs":["afamitresgene-autoleucel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04044768","phase":"2","setting":"A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma","sponsor":"USWM CT, LLC","started":"2019-08-13","startedType":"actual","yearReported":2025,"enrolled":52,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Response Rate (ORR) (Cohort 1)","primary":true,"unit":"%","arms":[{"name":"Synovial Sarcoma","n":44,"value":38.6,"note":"95% CI 24.36 to 54.50; Figures from the ClinicalTrials.gov results section (first posted 2025-01-13), not from a publication"},{"name":"MRCLS","n":8,"value":25,"note":"95% CI 3.19 to 65.09"}],"source":"https://clinicaltrials.gov/study/NCT04044768?tab=results"}]},{"id":"nct05642455","kind":"trial","name":"SPEARHEAD-3 Pediatric Study","aka":["SPEARHEAD-3"],"tldr":"A phase 1/2 trial of Afamitresgene autoleucel in osteosarcoma, run by USWM CT, LLC, now recruiting.","summary":"SPEARHEAD-3 Pediatric Study is a phase 1/2 interventional study registered as NCT05642455 by USWM CT, LLC, with 20 participants planned, started 2023-09-01 and due to reach its primary completion in 2026-10-01. Interventions recorded: Afamitresgene autoleucel. Conditions listed: Synovial Sarcoma, Malignant Peripheral Nerve Sheath Tumor (MPNST), Neuroblastoma (NBL), Osteosarcoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05642455","url":"https://clinicaltrials.gov/study/NCT05642455"}],"tags":["ctgov-ingest"],"related":[],"cancers":["osteosarcoma"],"sections":[],"technologies":["tcr-t"],"targets":[],"drugs":["afamitresgene-autoleucel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05642455","phase":"1/2","setting":"A Phase 1/2 Open Label, Basket Study to Assess the Safety, Tolerability and Anti-Tumor Activity of Afamitresgene Autoleucel in Pediatric Subjects With MAGE-A4 Positive Tumors","sponsor":"USWM CT, LLC","started":"2023-09-01","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05482893","kind":"trial","name":"Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junct","aka":[],"tldr":"A phase 1/2 trial of Spevatamig, Paclitaxel / nab-paclitaxel, Gemcitabine in pancreatic ductal adenocarcinoma, run by Phanes Therapeutics, now recruiting.","summary":"Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study) is a phase 1/2 interventional study registered as NCT05482893 by Phanes Therapeutics, with 258 participants planned, started 2023-03-15 and due to reach its primary completion in 2027-12. Interventions recorded: Spevatamig (PT886), Paclitaxel, Gemcitabine, Abraxane, KEYTRUDA® (pembrolizumab). Conditions listed: Gastric or Gastroesophageal Junction Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer (BTC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05482893","url":"https://clinicaltrials.gov/study/NCT05482893"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["spevatamig","paclitaxel","gemcitabine","pembrolizumab","folfox","capox"],"companies":["phanes-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05482893","phase":"1/2","setting":"A Phase 1/2, Open-Label, Dose Escalation and Expansion Study With PT886 (Spevatamig) Followed by a Multi-cohorT Study in Patients With Advanced GastrIc, Gastroesophageal JuNction, Pancreatic Ductal or Biliary Tract AdEnocarcinomas of PT886, in Combination With ChemotherApy, and/or an Immune ChecKpoint Inhibitor. The TWINPEAK Study","sponsor":"Phanes Therapeutics","started":"2023-03-15","startedType":"actual","enrolled":258,"enrolledBasis":"registry","outcomes":[]},{"id":"spinet","kind":"trial","name":"SPINET","aka":[],"tldr":"SPINET tried to prove that the somatostatin analogue lanreotide slows lung carcinoid tumours, as it does gut tumours, but recruited too few patients to give a definitive answer; the small comparison favoured the drug and it is used on that basis.","summary":"Somatostatin analogues are the first-line treatment for advanced gut and pancreatic neuroendocrine tumours on the strength of the PROMID and CLARINET trials, but their use in lung carcinoids rested on extrapolation. SPINET randomised patients with somatostatin-receptor-positive, well-differentiated typical or atypical lung neuroendocrine tumours to lanreotide autogel 120 mg or placebo, with progression-free survival as the primary endpoint.\n\nRecruitment was slow and the trial closed early with 77 patients, well short of its target. In the reduced population progression-free survival was longer with lanreotide than with placebo, in line with the gut trials, but the trial was underpowered for a formal conclusion. Guidelines still recommend somatostatin analogues for receptor-positive lung carcinoids on this and the gut evidence.","status":"mixed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02683941","url":"https://clinicaltrials.gov/study/NCT02683941"}],"tags":["subtype-trials"],"related":[],"cancers":["lung-net","neuroendocrine"],"sections":[],"technologies":[],"targets":[],"drugs":["octreotide-lanreotide"],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02683941","phase":"3","setting":"Unresectable or metastatic well-differentiated typical or atypical lung neuroendocrine tumours: lanreotide autogel against placebo","sponsor":"Ipsen","result":"Closed early for slow recruitment; the underpowered comparison favoured lanreotide over placebo for progression-free survival.","started":"2017-03-06","startedType":"actual","yearReported":2021,"enrolled":77,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival on lanreotide across double-blind and open-label phases (adapted primary endpoint)","primary":true,"unit":"months","arms":[{"name":"Lanreotide autogel 120 mg + best supportive care","n":51,"value":16.6,"note":"95% CI 11.3 to 21.9; recruitment stopped early"}],"source":"https://doi.org/10.1530/erc-23-0337"},{"endpoint":"Progression-free survival, double-blind phase","unit":"months","arms":[{"name":"Lanreotide autogel 120 mg + best supportive care","n":51,"value":16.6,"note":"Not significant"},{"name":"Placebo + best supportive care","n":26,"value":13.6}],"source":"https://doi.org/10.1530/erc-23-0337"},{"endpoint":"Progression-free survival, double-blind phase, typical carcinoids","unit":"months","arms":[{"name":"Lanreotide autogel 120 mg + best supportive care","n":29,"value":21.9},{"name":"Placebo + best supportive care","n":16,"value":13.9}],"source":"https://doi.org/10.1530/erc-23-0337"}]},{"id":"splash","kind":"trial","name":"SPLASH","aka":[],"tldr":"In SPLASH, a second PSMA radioligand improved progression-free survival but not, so far, survival.","summary":"SPLASH, trial NCT04647526 sponsored by Lantheus through POINT Biopharma and reported in 2024, tested a second PSMA radioligand, 177Lu-PNT2002, also known as 177Lu-PSMA-I&T, against a switch of androgen receptor pathway inhibitor in PSMA-positive, taxane-naive metastatic castration-resistant prostate cancer. It randomised 412 men and met its primary radiographic progression-free survival endpoint, but the interim overall survival analysis was numerically unfavourable, with 46 percent of events and 84 percent crossover, and Lantheus deprioritised a US filing pending mature data. OnCo links it to prostate cancer and to the 177Lu-PSMA-I&T drug record; its effect was smaller than PSMAfore's with a different ligand and dosing, while ECLIPSE with the same ligand met its progression endpoint. Whether crossover masked a real benefit or the drug simply adds little is the open question.","status":"mixed","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT04647526","url":"https://clinicaltrials.gov/study/NCT04647526"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["radioligand-therapy"],"targets":[],"drugs":["lu177-psma-it"],"companies":["lantheus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-splash-front-oncol-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04647526","phase":"3","setting":"PSMA-positive mCRPC after one ARPI, taxane-naive: 177Lu-PNT2002 vs ARPI switch","sponsor":"Lantheus (POINT Biopharma)","result":"rPFS HR 0.71; interim OS HR 1.11.","started":"2021-02-25","startedType":"actual","yearReported":2024,"enrolled":455,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic progression-free survival","primary":true,"unit":"months","arms":[{"name":"177Lu-PNT2002 (PSMA-I&T)","n":276,"value":9.5},{"name":"ARPI switch","n":136,"value":6}],"hr":0.71,"ci":[0.55,0.92],"p":"0.0088","source":"https://clinicaltrials.gov/study/NCT04647526"},{"endpoint":"Overall survival (interim)","unit":"months","arms":[{"name":"177Lu-PNT2002","note":"Numerically unfavourable at interim with crossover"},{"name":"ARPI switch"}],"hr":1.11,"source":"https://clinicaltrials.gov/study/NCT04647526"}],"replication":"Smaller effect than PSMAfore (rPFS HR 0.41) with a different ligand and dosing; ECLIPSE (177Lu-PSMA-I&T) met rPFS."},{"id":"nct05501665","kind":"trial","name":"Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of carboplatin, fludeoxyglucose F-18 (FDG), nab-paclitaxel, pembrolizumab and other drugs in lung cancer, run by Vanderbilt-Ingram Cancer Center, now recruiting.","summary":"Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer is a phase 1/2, interventional study registered as NCT05501665 by Vanderbilt-Ingram Cancer Center, with a registry enrolment figure of 25 participants, started 2023-05-09 and due to reach its primary completion in 2026-02-01. Interventions recorded: Biospecimen Collection; Carboplatin; Computed Tomography; Fludeoxyglucose F-18; Nab-paclitaxel; Pembrolizumab; Pemetrexed; Positron Emission Tomography; Radiation Therapy; [18-F] (fluoropropyl)-L-glutamate (FSPG) PET scan; Ipilimumab; Nivolumab; Cemiplimab; Atezolizumab. Conditions listed: Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage III Lung Cancer. Primary outcome: Incidence of adverse events; Best overall response rate. Lung eligibility wording from the registry: \"* • Histologically documented or cytologically confirmed diagnosis of stage IVA or IVB (M1b or M1c) or locally advanced (not eligible for standard of care \\[SOC\\] chemoradiation) non-small cell lung cancer with evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05501665","url":"https://clinicaltrials.gov/study/NCT05501665"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["carboplatin","fludeoxyglucose-f18","nab-paclitaxel","pembrolizumab","pemetrexed","ipilimumab","nivolumab","cemiplimab","atezolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05501665","phase":"1/2","setting":"SiCARIO (Split Course Adaptive Radioimmunotherapy) for the Treatment of Oligometastatic Non-Small Cell Lung Cancer (NSCLC) Using Biologically-Adaptive Radiotherapy - A Phase I/II Study","sponsor":"Vanderbilt-Ingram Cancer Center","started":"2023-05-09","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"spot-it","kind":"trial","name":"SPOT-IT","aka":["cutaneous SCC Prevention using tOpical Therapy in Immunosuppressed patienTs","ISRCTN80116429"],"tldr":"A prevention trial for the group who get these cancers worst: people on long-term immunosuppression, for whom squamous cell carcinoma is not an event but a recurring condition.","summary":"Organ transplant recipients and others on long-term immunosuppression develop cutaneous squamous cell carcinoma at many times the general rate, and they develop them repeatedly, which turns a curable cancer into a chronic surgical burden. SPOT-IT, sponsored by Cardiff University with a target of 673 participants and a registered end date of 31 December 2031, tests topical field treatment as prevention rather than as treatment of an established lesion. NICE NG34 recommendation 1.1.1 names immunosuppressed people among the groups who should take extra care in the sun; SPOT-IT asks whether the NHS can do more than advise them.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ISRCTN80116429","url":"https://www.isrctn.com/ISRCTN80116429"}],"tags":["uk","skin","prevention","recruiting"],"related":[],"cancers":["cutaneous-scc","skin-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN80116429","phase":"3","setting":"UK randomised trial of topical treatment to prevent cutaneous squamous cell carcinoma in immunosuppressed people; registered end date 31 December 2031","sponsor":"Cardiff University","enrolled":673,"enrolledBasis":"registry","outcomes":[]},{"id":"spotlight-glow","kind":"trial","name":"SPOTLIGHT & GLOW","aka":["SPOTLIGHT","GLOW","spotlight-glow"],"tldr":"Two trials that made Claudin 18.2 the third biomarker in stomach cancer, adding about two to three months of survival with an antibody against it.","summary":"SPOTLIGHT: PFS 10.6 vs 8.7 months, OS 18.2 vs 15.5 months. GLOW: PFS 8.2 vs 6.8, OS 14.4 vs 12.2 months. About 38% of screened patients were CLDN18.2-positive at the ≥75% threshold. FDA approval 18 October 2024 (Vyloy), first CLDN18.2-directed therapy. Nausea and vomiting, on-target from gastric mucosa, are frequent and front-loaded.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03504397","url":"https://clinicaltrials.gov/study/NCT03504397"},{"label":"GLOW NCT03653507","url":"https://clinicaltrials.gov/study/NCT03653507"}],"tags":[],"related":[],"cancers":["gastric","gastric-cldn18-2-positive"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["cldn18-2"],"drugs":["zolbetuximab","folfox","capox","oxaliplatin","capecitabine"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ryu-min-hee","shitara-kohei","rha-sun-young","kang-yoon-koo"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03504397","phase":"3","setting":"First-line CLDN18.2-positive (≥75% of cells), HER2-negative advanced gastric/GEJ adenocarcinoma: zolbetuximab + mFOLFOX6 (SPOTLIGHT) or CAPOX (GLOW) vs chemotherapy","sponsor":"Astellas","result":"SPOTLIGHT OS 18.2 vs 15.5 months; GLOW OS 14.4 vs 12.2 months.","started":"2018-06-21","startedType":"actual","yearReported":2023,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (SPOTLIGHT)","unit":"months","arms":[{"name":"Zolbetuximab + mFOLFOX6","value":18.2},{"name":"Placebo + mFOLFOX6","value":15.5}],"source":"https://www.gioncologynow.com/post/spotlight-glow-trials-lead-to-fda-approval-of-zolbetuximab-clzb-with-chemotherapy-for-gastric-gej-cancer"},{"endpoint":"Overall survival (GLOW)","unit":"months","arms":[{"name":"Zolbetuximab + CAPOX","value":14.4},{"name":"Placebo + CAPOX","value":12.2}],"source":"https://www.gioncologynow.com/post/spotlight-glow-trials-lead-to-fda-approval-of-zolbetuximab-clzb-with-chemotherapy-for-gastric-gej-cancer"}],"replication":"Two independent phase 3 trials with different chemotherapy backbones agree."},{"id":"squire","kind":"trial","name":"SQUIRE","aka":[],"tldr":"An EGFR antibody added to chemotherapy for squamous lung cancer: it worked, by about six weeks, and almost nobody uses it.","summary":"Necitumumab is a second-generation recombinant human IgG1 antibody against EGFR. SQUIRE ran at 184 sites in 26 countries and randomised 1,093 patients with untreated stage IV squamous non-small-cell lung cancer 1:1 to gemcitabine 1,250 mg/m2 on days 1 and 8 with cisplatin 75 mg/m2 on day 1, with or without necitumumab 800 mg on days 1 and 8. Chemotherapy ran for up to six 3-week cycles; necitumumab continued until progression. The trial was open-label because the acne-like rash characteristic of EGFR antibodies would have unmasked it anyway.\n\nOverall survival was significantly longer with necitumumab, by about six weeks at the median, at the cost of hypomagnesaemia, rash and venous thromboembolism. The FDA approved the combination in 2015 and the EMA in 2016 for EGFR-expressing squamous disease.\n\nSQUIRE is a study in what a statistically significant result is worth. The magnitude was small, the regimen was displaced within two years by pembrolizumab with carboplatin and paclitaxel (KEYNOTE-407), and necitumumab is now almost never given. It has no NICE appraisal.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00981058","url":"https://clinicaltrials.gov/study/NCT00981058"},{"label":"SQUIRE (Lancet Oncology 2015)","url":"https://doi.org/10.1016/S1470-2045(15)00021-2"}],"tags":[],"related":[],"cancers":["lung-squamous-cell-carcinoma","nsclc"],"sections":[],"technologies":["monoclonal-antibody","cytotoxic-chemotherapy","platinum"],"targets":["egfr"],"drugs":["necitumumab","gemcitabine","cisplatin"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":["keynote-407"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00981058","phase":"3","setting":"Untreated stage IV squamous non-small-cell lung cancer, performance status 0 to 2: up to six cycles of gemcitabine 1,250 mg/m2 on days 1 and 8 with cisplatin 75 mg/m2 on day 1, with or without necitumumab 800 mg on days 1 and 8 continued to progression, with overall survival as the primary endpoint","sponsor":"Eli Lilly","result":"Overall survival significantly longer with necitumumab added to gemcitabine and cisplatin, by roughly six weeks at the median; hypomagnesaemia, rash and thromboembolism were the added toxicities.","started":"2010-01-07","startedType":"actual","yearReported":2015,"enrolled":1093,"enrolledBasis":"registry","outcomes":[],"replication":"Not replicated. The companion trial in non-squamous disease, INSPIRE, was stopped early for excess thromboembolic death, so the indication is squamous only."},{"id":"nct06457906","kind":"trial","name":"SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC","aka":["SHARP"],"tldr":"A phase 3 trial in lung cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, now recruiting.","summary":"SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC is a phase 3, randomised interventional study registered as NCT06457906 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 340 participants, started 2023-09-01 and due to reach its primary completion in 2027-08-30. Interventions recorded: Experimental group (SRS/SRT/Hypo-RT); Controled group (HA-WBRT). Conditions listed: Small-cell Lung Cancer; Brain Metastases; SRS; Stereotactic Radiotherapy; Whole Brain Radiotherpay; Hippocampal-avoidance. Primary outcome: Cognitive function scores; Meadian OS time. Lung eligibility wording from the registry: \"Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06457906","url":"https://clinicaltrials.gov/study/NCT06457906"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06457906","phase":"3","setting":"SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in Patients With Small-Cell Lung Cancer: A Prospective, Randomized, Multicenter Phase III Trial (SHARP Trial)","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2023-09-01","startedType":"actual","enrolled":340,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07022002","kind":"trial","name":"SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors","aka":[],"tldr":"A phase 2 trial of SSGJ-705 in advanced solid tumours, run by Shenyang Sunshine Pharmaceutical Co., LTD., now recruiting.","summary":"SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors is a phase 2 interventional study registered as NCT07022002 by Shenyang Sunshine Pharmaceutical Co., LTD., with 340 participants planned, started 2025-07-30 and due to reach its primary completion in 2026-12-31. Interventions recorded: SSGJ-705, PD-1/L1 inhibitor combined with chemotherapy and SSGJ-705 combined with chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07022002","url":"https://clinicaltrials.gov/study/NCT07022002"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ssgj-705"],"companies":["3sbio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07022002","phase":"2","setting":"A Phase II Study to Evaluate the Safety and Efficacy of SSGJ-705 Monotherapy and Combination Therapy in Patients With Advanced HER2-Expressing Solid Tumors","sponsor":"Shenyang Sunshine Pharmaceutical Co., LTD.","started":"2025-07-30","startedType":"actual","enrolled":340,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07646626","kind":"trial","name":"SSGJ-705 Plus SSGJ-612 ± Chemotherapy in Advanced HER2-Expressing Solid Tumors","aka":[],"tldr":"A phase 2 trial of SSGJ-705 and SSGJ-612 in advanced solid tumours, run by Shenyang Sunshine Pharmaceutical Co., LTD., now recruiting.","summary":"SSGJ-705 Plus SSGJ-612 ± Chemotherapy in Advanced HER2-Expressing Solid Tumors is a phase 2 interventional study registered as NCT07646626 by Shenyang Sunshine Pharmaceutical Co., LTD., with 150 participants planned, started 2026-07-17 and due to reach its primary completion in 2027-06-30. Interventions recorded: SSGJ-705, SSGJ-612 and SSGJ-705 combined with chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07646626","url":"https://clinicaltrials.gov/study/NCT07646626"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ssgj-705","ssgj-612"],"companies":["3sbio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07646626","phase":"2","setting":"A Phase II Study of SSGJ-705 Plus SSGJ-612 ± Chemotherapy in Advanced HER2-Expressing Solid Tumors","sponsor":"Shenyang Sunshine Pharmaceutical Co., LTD.","started":"2026-07-17","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06980272","kind":"trial","name":"SSGJ-707 in Advanced Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial testing PF-08634404 in non-small-cell lung cancer, now recruiting.","summary":"SSGJ-707 in Advanced Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06980272, led by Shenyang Sunshine Pharmaceutical, and recruiting on the registry. Official title: A Randomised Controlled, Multi-centre Phase III Clinical Trial of SSGJ-707 Versus Pembrolizumab as First-line Treatment for PD-L1-Positive Locally-Advanced or Metastatic Non-Small Cell Lung Cancer. Planned enrolment is 420 participants (estimated). The study started in 2025-06-20 and primary completion is expected in 2026-07-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06980272","url":"https://clinicaltrials.gov/study/NCT06980272"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-08634404"],"companies":["3sbio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06980272","phase":"3","setting":"A Randomized Controlled, Multi-center Phase III Clinical Trial of SSGJ-707 Versus Pembrolizumab as First-line Treatment for PD-L1-Positive Locally-Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Shenyang Sunshine Pharmaceutical","started":"2025-06-20","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"ssgxviii","kind":"trial","name":"SSGXVIII/AIO (adjuvant imatinib in GIST)","aka":[],"tldr":"In SSGXVIII/AIO, three years of imatinib after surgery, rather than one, improved survival in high-risk GIST.","summary":"SSGXVIII/AIO, trial NCT00116935 sponsored by the Scandinavian Sarcoma Group and the German AIO and published in JAMA in 2012, showed that three years of adjuvant imatinib after surgery, rather than one, improves recurrence-free and overall survival in high-risk gastrointestinal stromal tumour. It randomised 400 patients and met its primary recurrence-free survival endpoint at five years with a survival benefit that held at ten years. OnCo links it to sarcomas and GIST, KIT as a target and imatinib. Trials of five to six years of imatinib, SSG XXII and IMADGIST, suggest further recurrence-free benefit, and how long adjuvant imatinib should continue is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00116935","url":"https://clinicaltrials.gov/study/NCT00116935"}],"tags":[],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["kit"],"drugs":["imatinib"],"companies":["aio","scandinavian-sarcoma-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00116935","phase":"3","setting":"High-risk resected GIST: adjuvant imatinib 3 years vs 1 year","sponsor":"Scandinavian Sarcoma Group / AIO","result":"RFS HR 0.46; OS HR 0.45 (5 years).","started":"2004-02","yearReported":2012,"enrolled":400,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Imatinib 3 years","n":198,"value":65.6},{"name":"Imatinib 1 year","n":199,"value":47.9}],"hr":0.46,"ci":[0.32,0.65],"source":"https://jamanetwork.com/journals/jama/fullarticle/1105059"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Imatinib 3 years","value":92},{"name":"Imatinib 1 year","value":81.7}],"hr":0.45,"source":"https://doi.org/10.1001/jama.2012.347"}]},{"id":"stamp-merkel","kind":"trial","name":"STAMP (EA6174)","aka":["STAMP","ECOG-ACRIN EA6174"],"tldr":"STAMP asks whether a year of pembrolizumab after surgery for Merkel cell carcinoma, a skin cancer that often comes back, prevents recurrence; it is one of two randomised trials testing adjuvant immunotherapy in this disease.","summary":"Merkel cell carcinoma recurs in a large share of patients after surgery and radiotherapy, and PD-1 blockade is highly active in advanced disease. STAMP is an ECOG-ACRIN phase 3 trial randomising 280 patients with completely resected stage I to III Merkel cell carcinoma to pembrolizumab every three or six weeks for one year or to observation, with radiotherapy permitted in both arms. The primary endpoint is recurrence-free survival.\n\nThe trial is ongoing and has not reported. The German ADMEC-O trial of adjuvant nivolumab reported a recurrence-free survival advantage in 2023, and STAMP is the larger confirmatory test of the approach.","status":"active","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03712605","url":"https://clinicaltrials.gov/study/NCT03712605"}],"tags":["subtype-trials"],"related":[],"cancers":["merkel-cell-carcinoma","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["ecog-acrin"],"institutions":[],"pathways":[],"terms":[],"trials":["admec-o","pod1um-201"],"people":["shailender-bhatia"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03712605","phase":"3","setting":"Resected stage I to III Merkel cell carcinoma: one year of adjuvant pembrolizumab against observation","sponsor":"ECOG-ACRIN (National Cancer Institute)","started":"2018-11-15","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"stampede","kind":"trial","name":"STAMPEDE","aka":["STAMPEDE trial","MRC PR08","Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy","STAMPEDE platform"],"tldr":"STAMPEDE is the longest-running platform trial in oncology, and showed that both docetaxel and abiraterone extend life when started at first diagnosis of metastatic disease.","summary":"STAMPEDE opened in 2005 at the MRC Clinical Trials Unit at UCL, with Nicholas James as chief investigator and Mahesh Parmar as its statistician, as the first multi-arm multi-stage trial in cancer: several experimental arms recruited at once against one control arm of androgen deprivation therapy, each passing through interim activity stages before being allowed to continue to an overall survival comparison, with new arms added and failing arms dropped as the standard of care moved. Nearly 12,000 men with high-risk locally advanced or newly metastatic prostate cancer joined at more than 100 hospitals in the United Kingdom and Switzerland; Silke Gillessen led the Swiss contribution and later co-chaired the trial. The original arms added zoledronic acid, docetaxel, celecoxib and their combinations; the celecoxib arms were stopped for lack of activity in 2011, and abiraterone (2011), radiotherapy to the prostate (2013), abiraterone with enzalutamide (2014), metformin (2016) and transdermal oestradiol (run jointly with the PATCH trial) were added.\n\nThe results arrived in sequence and each changed practice. In 2016 the Lancet reported that docetaxel added to hormone therapy improved overall survival, most clearly in metastatic disease, while zoledronic acid added nothing; the finding replicated CHAARTED and made early chemotherapy a standard. In 2017 the New England Journal of Medicine reported, alongside LATITUDE, that abiraterone with prednisolone cut the risk of death by about a third (hazard ratio 0.63), which established abiraterone at first diagnosis of metastatic disease. In 2018 the Lancet reported that radiotherapy to the prostate improved survival in men with a low metastatic burden but not overall, and low-volume prostate radiotherapy entered guidelines. In 2022 the Lancet reported that two years of abiraterone improved metastasis-free and overall survival in high-risk non-metastatic disease, and that adding enzalutamide brought toxicity without benefit; the Lancet Oncology in 2023 confirmed the same for enzalutamide in metastatic disease. The metformin comparison, reported at ESMO in 2024 and since published, found no overall survival benefit from adding metformin for men starting hormone therapy for metastatic disease. The transdermal oestradiol comparison, run with PATCH, showed that oestrogen patches suppress testosterone as well as injections with fewer hot flushes, better bone health and no excess of cardiovascular events (Lancet 2021).\n\nSTAMPEDE is the proof that a single academic platform with a shared control arm can answer a decade of questions faster and more cheaply than separate trials, and its multi-arm multi-stage design is now used across cancer and beyond. Its weaknesses are the ones every platform inherits: the control arm changed as docetaxel and then abiraterone became standard, so later arms were compared with a moving baseline, and some comparisons (radiotherapy, enzalutamide) were read in subgroups defined after the fact. The successor, STAMPEDE2, opened in 2023 with comparisons of stereotactic radiotherapy to metastases, lutetium PSMA radioligand therapy and niraparib with abiraterone in men starting treatment for metastatic disease.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT00268476","url":"https://clinicaltrials.gov/study/NCT00268476"},{"label":"James et al., Lancet 2016: addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE)","url":"https://doi.org/10.1016/S0140-6736(15)01037-5"},{"label":"James et al., NEJM 2017: abiraterone for prostate cancer not previously treated with hormone therapy (STAMPEDE)","url":"https://doi.org/10.1056/NEJMoa1702900"},{"label":"Parker et al., Lancet 2018: radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE)","url":"https://doi.org/10.1016/S0140-6736(18)32486-3"},{"label":"Attard et al., Lancet 2022: abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer (STAMPEDE)","url":"https://doi.org/10.1016/S0140-6736(21)02437-5"},{"label":"Attard et al., Lancet Oncology 2023: abiraterone plus prednisolone with or without enzalutamide for metastatic prostate cancer starting ADT (STAMPEDE)","url":"https://doi.org/10.1016/S1470-2045(23)00148-1"},{"label":"Langley et al., Lancet 2021: transdermal oestradiol for androgen suppression in prostate cancer, long-term cardiovascular outcomes from PATCH","url":"https://doi.org/10.1016/S0140-6736(21)00100-8"},{"label":"STAMPEDE trial website (MRC CTU at UCL)","url":"https://www.stampedetrial.org"},{"label":"STAMPEDE metformin (Lancet Oncology 2025)","url":"https://doi.org/10.1016/S1470-2045(25)00231-1"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation","cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["abiraterone","docetaxel","enzalutamide","zoledronic-acid","celecoxib"],"companies":["mrc-ctu"],"institutions":["uclh","icr-london","royal-marsden"],"pathways":[],"terms":["master-protocol","seamless-adaptive","basket-umbrella-platform","mcrpc-mhspc","interim-analysis","prostate-stampede-arms"],"trials":["patch-transdermal-oestradiol","rtog-0521","getug-afu-15"],"people":["silke-gillessen","mahesh-parmar","nicholas-james","gerhardt-attard"],"bottlenecks":[],"keyPapers":["paper-parker-lancet","paper-langley-lancet","paper-attard-lancet-oncol","paper-stampede-lancet-2016","paper-stampede-plos-med-2022-update"],"journals":[],"dependsOn":[],"notes":["The STAMPEDE metformin comparison, reported in Lancet Oncology in 2025, randomised 1,874 men with metastatic disease and no diabetes (HbA1c below 48 mmol/mol) and adequate renal function to standard of care or standard of care plus metformin 850 mg twice daily. Standard of care was androgen deprivation with or without radiotherapy and with or without docetaxel or an androgen receptor pathway inhibitor; 1,543 of 1,874 (82 percent) received docetaxel and 52 (3 percent) an androgen receptor pathway inhibitor. At a median 60 months of follow-up there were 473 deaths on standard of care (median survival 61.8 months) and 453 with metformin (67.4 months), hazard ratio 0.91 (95 percent confidence interval 0.80 to 1.03, p=0.15). Grade 3 or worse adverse events occurred in 52 percent against 57 percent, the excess being gastrointestinal. There were six drug-related deaths on standard of care and one with metformin.","The high-risk non-metastatic comparison, reported in the Lancet in 2022 as a meta-analysis of two STAMPEDE randomisations in 1,974 men at 113 sites in the United Kingdom and Switzerland, found metastasis-free survival significantly longer with 2 years of abiraterone added to 3 years of androgen deprivation, hazard ratio 0.53 (95 percent confidence interval 0.44 to 0.64, p<0.0001), with 6-year metastasis-free survival 82 percent (79 to 85) against 69 percent (66 to 72). Adding enzalutamide to abiraterone gave no further benefit (interaction hazard ratio 1.02, 0.70 to 1.50, p=0.91) and no between-trial heterogeneity was seen. Median age was 68, median PSA 34 ng/mL, 39 percent were node positive and 85 percent were planned to receive radiotherapy.","The prostate radiotherapy comparison randomised 2,061 men with newly diagnosed metastatic disease at 117 hospitals between 22 January 2013 and 2 September 2016. Failure-free survival improved (hazard ratio 0.76, 95 percent confidence interval 0.68 to 0.84, p<0.0001) but overall survival did not (0.92, 0.80 to 1.06, p=0.266). Forty percent had low metastatic burden and 54 percent high. Radiotherapy was well tolerated, with 48 men (5 percent) reporting RTOG grade 3 to 4 events during radiotherapy and 37 (4 percent) after it."],"nct":"NCT00268476","phase":"platform","setting":"Multi-arm multi-stage platform in men starting long-term hormone therapy for high-risk locally advanced or metastatic prostate cancer: docetaxel, zoledronic acid, celecoxib, abiraterone, radiotherapy to the prostate, abiraterone with enzalutamide, metformin and transdermal oestradiol added to ADT and compared with ADT alone","sponsor":"MRC Clinical Trials Unit at UCL, funded by Cancer Research UK and the Medical Research Council","result":"Abiraterone + ADT: OS HR 0.63 in mHSPC; docetaxel + ADT: OS HR 0.78. Prostate radiotherapy improved survival in low-volume metastatic disease; abiraterone improved survival in high-risk non-metastatic disease; enzalutamide added to abiraterone, zoledronic acid, celecoxib and metformin did not improve survival.","started":"2005-07-08","startedType":"actual","yearReported":2016,"enrolled":11992,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, abiraterone arm (M1 subgroup)","primary":true,"unit":"%","arms":[{"name":"ADT + abiraterone","note":"6-year OS 60%"},{"name":"ADT alone","note":"6-year OS 45%"}],"hr":0.6,"ci":[0.5,0.71],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00367-1/fulltext"},{"endpoint":"Overall survival, docetaxel arm (M1)","unit":"months","arms":[{"name":"ADT + docetaxel","value":60},{"name":"ADT alone","value":45}],"hr":0.76,"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01037-5/fulltext"},{"endpoint":"Overall survival, abiraterone comparison","unit":"deaths","arms":[{"name":"Androgen deprivation with abiraterone and prednisolone","n":960,"value":184},{"name":"Androgen deprivation alone","n":957,"value":262}],"hr":0.63,"ci":[0.52,0.76],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1702900"},{"endpoint":"Metastasis-free survival at 6 years, high-risk non-metastatic comparison","unit":"%","arms":[{"name":"Androgen deprivation with 2 years of abiraterone","value":82},{"name":"Androgen deprivation alone","value":69}],"hr":0.53,"ci":[0.44,0.64],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(21)02437-5"},{"endpoint":"Overall survival, prostate radiotherapy comparison","arms":[{"name":"Standard of care with prostate radiotherapy","n":1032},{"name":"Standard of care","n":1029}],"hr":0.92,"ci":[0.8,1.06],"p":"0.266","source":"https://doi.org/10.1016/S0140-6736(18)32486-3"},{"endpoint":"Overall survival (median), metformin comparison","unit":"months","arms":[{"name":"Standard of care with metformin","n":936,"value":67.4},{"name":"Standard of care","n":938,"value":61.8}],"hr":0.91,"ci":[0.8,1.03],"p":"0.15","source":"https://doi.org/10.1016/S1470-2045(25)00231-1"}],"replication":"Abiraterone result replicated by LATITUDE; docetaxel result replicated by CHAARTED."},{"id":"nct04722978","kind":"trial","name":"Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer","aka":[],"tldr":"A phase 3 trial of gemcitabine and carboplatin in triple-negative breast cancer, run by Sun Yat-Sen University Cancer Center, now recruiting.","summary":"Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer is a phase 3, randomised interventional study registered as NCT04722978 by Sun Yat-Sen University Cancer Center, with a registry enrolment figure of 228 participants, started 2021-04-20 and due to reach its primary completion in 2026-06. Interventions recorded: Gemcitabine and carboplatin plus antibiotic (moxifloxacin); Gemcitabine combined with carboplatin plus placebo. Conditions listed: Triple Negative Breast Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04722978","url":"https://clinicaltrials.gov/study/NCT04722978"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04722978","phase":"3","setting":"Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer : a Multicenter, Double-blind, Placebo-controlled, Phase 3 Trial","sponsor":"Sun Yat-Sen University Cancer Center","started":"2021-04-20","startedType":"actual","enrolled":228,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04095299","kind":"trial","name":"Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients","aka":["WW3"],"tldr":"A phase 3 trial in colorectal cancer, run by Vejle Hospital, now recruiting.","summary":"Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients is a phase 3, randomised interventional study registered as NCT04095299 by Vejle Hospital, with a registry enrolment figure of 162 participants, started 2020-01-20 and due to reach its primary completion in 2026-12. Interventions recorded: 50.4 Gy to the tumor and elective volume; 62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume; Capecitabine 825 mg/m2 twice daily on weekdays. Conditions listed: Cancer of Rectum. Primary outcome: Rectal preservation at two years. Colorectal eligibility wording from the registry: \"* Histopathologically verified adenocarcinoma of the rectum\". Sites: Denmark. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04095299","url":"https://clinicaltrials.gov/study/NCT04095299"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04095299","phase":"3","setting":"Randomized Trial of Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy to Patients With Early Low and Mid Rectal Cancer: The Watchful Waiting 3 Trial (WW3)","sponsor":"Vejle Hospital","started":"2020-01-20","startedType":"actual","enrolled":162,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05278052","kind":"trial","name":"Standard Maintenance Therapy (SMT) vs Local Consolidative Radiation Therapy and SMT in OM-NSCLC","aka":["TARGET-02"],"tldr":"A phase 3 trial in lung cancer, run by Tata Memorial Hospital, now recruiting.","summary":"Standard Maintenance Therapy (SMT) vs Local Consolidative Radiation Therapy and SMT in OM-NSCLC is a phase 3, randomised interventional study registered as NCT05278052 by Tata Memorial Hospital, with a registry enrolment figure of 190 participants, started 2020-04-20 and due to reach its primary completion in 2026-04-20. Interventions recorded: Local consolidative radiation therapy; Standard maintenance therapy as decided by the treating medical oncologist. Conditions listed: Oligometastatic Disease; Metastatic Non Small Cell Lung Cancer. Primary outcome: Overall survival (OS). Lung eligibility wording from the registry: \"Patients with pathologically proven diagnosis of NSCLC\". Sites: India. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05278052","url":"https://clinicaltrials.gov/study/NCT05278052"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05278052","phase":"3","setting":"Standard Maintenance Therapy Versus Local Consolidative Radiation Therapy and Standard Maintenance Therapy in 1-5 Sites of Oligometastatic Non-small Cell Lung Cancer (NSCLC): A Phase III Randomized Controlled Trial","sponsor":"Tata Memorial Hospital","started":"2020-04-20","startedType":"actual","enrolled":190,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06714604","kind":"trial","name":"Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC","aka":["ADVANTAGE"],"tldr":"A phase 3 trial in pancreatic cancer, run by Sahlgrenska University Hospital, now recruiting.","summary":"Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC is a phase 3, randomised interventional study registered as NCT06714604 by Sahlgrenska University Hospital, with a registry enrolment figure of 432 participants, started 2023-10-18 and due to reach its primary completion in 2032-12-31. Interventions recorded: FOLFIRINOX or gemcitabine-nab-paclitaxel; FOLFIRINOX or gemcitabine-nab-paclitaxel. Conditions listed: Locally Advanced Pancreatic Adenocarcinoma; Borderline Resectable Pancreatic Carcinoma; Pancreas Cancer; Neoadjuvant Chemotherapy; Surgery; Pancreatectomy. Primary outcome: Overall survival of all BR/LAPC patients; Overall survival of all resected BR/LAPC patients. Pancreatic eligibility wording from the registry: \"* Borderline or locally advanced pancreatic adenocarcinoma at diagnosis according to National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, version 1\". Sites: Sweden. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06714604","url":"https://clinicaltrials.gov/study/NCT06714604"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac","locally-advanced-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06714604","phase":"3","setting":"Standard Versus Prolonged Neoadjuvant (Conversion) Chemotherapy to Prolong Survival of Patients With Borderline and Locally Advanced Pancreatic Cancer: a Phase III Randomized Controlled","sponsor":"Sahlgrenska University Hospital","started":"2023-10-18","startedType":"actual","enrolled":432,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07106034","kind":"trial","name":"Standard Second-line Therapy With ONgericimab and TOripalimab in pMMR/MSS Colorectal Cancer: a Single-arm Phase II Trial","aka":["ONTOP"],"tldr":"A phase 2 trial in colorectal cancer, run by Shanghai Pudong Hospital, now recruiting.","summary":"Standard Second-line Therapy With ONgericimab and TOripalimab in pMMR/MSS Colorectal Cancer: a Single-arm Phase II Trial is a phase 2, interventional study registered as NCT07106034 by Shanghai Pudong Hospital, with a registry enrolment figure of 32 participants, started 2025-08-31 and due to reach its primary completion in 2027-07-31. Interventions recorded: Ongericimab + Toripalimab + Bevacizumab + FOLFOX; Ongericimab + Toripalimab + Bevacizumab + FOLFIRI. Conditions listed: Advanced Colorectal Cancer. Primary outcome: overall response rate. Colorectal eligibility wording from the registry: \"Histologically confirmed MSS/pMMR colorectal or rectal cancer, who have progressed on first-line fluoropyrimidine - based combination therapy (including progression during maintenance therapy)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07106034","url":"https://clinicaltrials.gov/study/NCT07106034"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07106034","phase":"2","setting":"Clinical Study of Second-Line Standard Therapy Combined With Ongericimab and Toripalimab in Patients With MSS/pMMR Colorectal Cancer Following First-Line Treatment Failure","sponsor":"Shanghai Pudong Hospital","started":"2025-08-31","startedType":"actual","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06525428","kind":"trial","name":"Standard Systemic Therapy Combined With High/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of toripalimab in colorectal cancer, run by Fudan University, now recruiting.","summary":"Standard Systemic Therapy Combined With High/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06525428 by Fudan University, with a registry enrolment figure of 96 participants, started 2024-04-01 and due to reach its primary completion in 2026-12. Interventions recorded: standard systemic therapy combined with high/low-dose radiotherapy plus toripalimab. Conditions listed: Microsatellite Stable Metastatic Colorectal Cancer. Primary outcome: PFS. Colorectal eligibility wording from the registry: \"Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06525428","url":"https://clinicaltrials.gov/study/NCT06525428"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06525428","phase":"2","setting":"A Prospective, Two-cohort Phase II Trial of Standard Systemic Therapy in Combination With High/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer","sponsor":"Fudan University","started":"2024-04-01","startedType":"actual","enrolled":96,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03678025","kind":"trial","name":"Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Abiraterone acetate, Bicalutamide, Degarelix, Docetaxel, Flutamide, Goserelin / leuprolide, Histrelin, Leuprolide, Nilutamide, Prednisone and Triptorelin in Prostate cancer, run by SWOG Cancer Research Network, now recruiting.","summary":"Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer is a phase 3 interventional study registered as NCT03678025 by SWOG Cancer Research Network, with 1273 participants planned, started 2018-09-24 and due to reach its primary completion in 2028-04-01. Interventions recorded: Abiraterone, Bicalutamide, Degarelix, Docetaxel, Flutamide, Goserelin Acetate, Histrelin Acetate, Leuprolide Acetate, Nilutamide, Orchiectomy, Prednisone, Quality-of-Life Assessment, Radiation Therapy, Radical Prostatectomy, Triptorelin. Conditions recorded: Castration Levels of Testosterone, Metastatic Prostatic Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8.\n\nLinked to the drug Flutamide because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03678025","url":"https://clinicaltrials.gov/study/NCT03678025"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["abiraterone","bicalutamide","degarelix","docetaxel","flutamide","goserelin","histrelin","leuprolide","nilutamide","prednisone","triptorelin"],"companies":["swog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03678025","phase":"3","setting":"Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer","sponsor":"SWOG Cancer Research Network","started":"2018-09-24","startedType":"actual","enrolled":1273,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07076693","kind":"trial","name":"Standard-of-care Systemic Therapy With or Without Local Therapy in Patients With Oligoprogressive Non-Small Cell Lung Cancer(NSCLC）","aka":[],"tldr":"A phase 2/3 trial in lung cancer, run by Shanghai Chest Hospital, active but no longer recruiting.","summary":"Standard-of-care Systemic Therapy With or Without Local Therapy in Patients With Oligoprogressive Non-Small Cell Lung Cancer(NSCLC） is a phase 2/3, randomised interventional study registered as NCT07076693 by Shanghai Chest Hospital, with a registry enrolment figure of 97 participants, started 2025-06-03 and due to reach its primary completion in 2028-05-31. Interventions recorded: Radiotherapy or Surgery; Standard Medical Therapy. Conditions listed: OligoProgressive Metastatic Disease; Non-Small Cell Lung Cancer. Primary outcome: Objective Response Rate (ORR); Progression-free survival (PFS). Lung eligibility wording from the registry: \"For Epidermal Growth Factor Receptor (EGFR)-sensitive mutant non-squamous NSCLC patients, first-line treatment must be the third-generation TKIs or progression after first/second-generation TKI without harboring T790M mutation, with ≤3 progressive lesions and ≤3 metastatic organs (PET-CT + cranial M\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07076693","url":"https://clinicaltrials.gov/study/NCT07076693"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07076693","phase":"2/3","setting":"Standard-of-care Systemic Therapy With or Without Local Therapy in Patients With Oligoprogressive NSCLC: A Prospective, Randomized Controlled Phase II/III Clinical Trial","sponsor":"Shanghai Chest Hospital","started":"2025-06-03","startedType":"actual","enrolled":97,"enrolledBasis":"registry","outcomes":[]},{"id":"star-trec","kind":"trial","name":"STAR-TREC","aka":["ISRCTN14240288"],"tldr":"The UK-led trial asking whether people with rectal cancer can keep their rectum: give radiotherapy, see how the tumour responds, and operate only if it has to be removed.","summary":"STAR-TREC is the British answer to the organ-preservation question the American PROSPECT trial approached from the other direction. It randomised people with early and intermediate stage rectal cancer between total mesorectal excision and two response-adapted radiotherapy schedules, long-course chemoradiotherapy or short-course radiotherapy, each followed by assessment and either watchful waiting or local excision. Its 12-month results, published in Lancet Oncology in 2026 with Simon Bach as first author and David Sebag-Montefiore as second, are the first randomised comparison of the two radiotherapy schedules for organ preservation. NICE NG151 recommendation 1.3.7 already tells teams to warn people who defer surgery after a complete response that recurrence is possible and to encourage them into a trial with data collected in a national registry, which is what STAR-TREC provides.","status":"active","asOf":"2026-09-24","links":[{"label":"Lancet Oncology 2026: 12-month results","url":"https://europepmc.org/article/MED/42633754"},{"label":"ISRCTN14240288","url":"https://www.isrctn.com/ISRCTN14240288"}],"tags":["uk","rectal","organ-preservation"],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":["radiation","surgery"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["birmingham-cancer-centre","leeds-cancer-centre"],"pathways":[],"terms":["clinical-complete-response"],"trials":[],"people":["david-sebag-montefiore","dion-morton"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN14240288","phase":"3","setting":"Organ preservation in early and intermediate rectal cancer: long-course chemoradiotherapy against short-course radiotherapy, both followed by response assessment and either watch and wait or local excision, against total mesorectal excision; 34 centres in England, Scotland, Wales, Denmark and the Netherlands; recruitment closed 31 December 2023, follow-up to 2027","sponsor":"University of Birmingham","yearReported":2026,"enrolled":344,"enrolledBasis":"randomised","enrolledNote":"The Lancet Oncology 2026 report of 12-month results describes the randomised population; the ISRCTN record gives recruitment from 1 November 2016 to 31 December 2023 at 34 centres.","outcomes":[]},{"id":"starglo","kind":"trial","name":"STARGLO","aka":[],"tldr":"A bispecific plus chemotherapy improved survival in relapsed lymphoma, but a US advisory committee voted eight to one that the trial did not apply to American patients, and the second-line use is still not on the US label.","summary":"STARGLO, trial NCT04408638 sponsored by Roche and published in the Lancet in 2024, showed that the CD20 by CD3 bispecific glofitamab with gemcitabine and oxaliplatin improved survival over rituximab plus the same chemotherapy in relapsed or refractory diffuse large B-cell lymphoma in transplant-ineligible patients. It randomised 274 patients, met its primary overall survival endpoint with a large progression benefit, and won EU approval in 2025.\n\nThe United States went the other way, and what is on the public record is this. On 20 May 2025 the Oncologic Drugs Advisory Committee discussed supplemental biologics licence application 761309/S-001 for Columvi, for use with gemcitabine and oxaliplatin in adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who are not candidates for autologous stem cell transplant. The committee was asked whether the STARGLO population and trial results are applicable to the proposed US patient population and voted No 8, Yes 1, Abstain 0. The FDA's own minutes record the reasons: the limited number of US patients enrolled, inconsistencies between Asian and non-Asian populations, non-adherence to the ICH E17 guidance on multiregional trials, and subgroup analyses showing inferior results in non-Asian patients across overall survival, progression-free survival, response rate and complete response. The glofitamab label effective 25 June 2026 still carries only the accelerated approval after two or more lines, so the second-line indication was not granted. OnCo has previously recorded a complete response letter here, citing a trade publication; the FDA does not routinely publish complete response letters and no primary source for one was found, so the claim has been replaced with what the agency's own documents say. Whether regional heterogeneity reflected biology, practice or chance is the open question.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04408638","url":"https://clinicaltrials.gov/study/NCT04408638"},{"label":"FDA Oncologic Drugs Advisory Committee, 20 to 21 May 2025: meeting page","url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/may-20-21-2025-meeting-oncologic-drugs-advisory-committee-05202025"},{"label":"FDA meeting minutes, 20 May 2025 (vote: No 8, Yes 1)","url":"https://www.fda.gov/media/187747/download"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["glofitamab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["michael-dickinson"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04408638","phase":"3","setting":"R/R DLBCL, transplant-ineligible, ≥1 prior line: glofitamab + GemOx vs rituximab + GemOx","sponsor":"Roche","result":"Overall survival hazard ratio 0.62. A US advisory committee voted 8 to 1 that the trial was not applicable to the US population, and the second-line indication is absent from the US label.","started":"2021-02-23","startedType":"actual","yearReported":2024,"enrolled":274,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Glofit-GemOx","n":183,"value":25.5},{"name":"R-GemOx","n":91,"value":12.9}],"hr":0.62,"ci":[0.43,0.88],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02565-4/fulltext"}],"replication":"Not replicated; applicability to Western populations rejected by the FDA Oncologic Drugs Advisory Committee on 20 May 2025 by 8 votes to 1."},{"id":"starpac2","kind":"trial","name":"STARPAC2","aka":["STARPAC 2","STAR_PAC2"],"tldr":"STARPAC2 is a UK trial repurposing the vitamin A derivative used in leukaemia to soften the scar tissue around pancreatic tumours so chemotherapy works better; it follows a phase 1 (STAR_PAC) at Barts and has closed to recruitment with results due after 2028.","summary":"STARPAC2 (ISRCTN11503604, NCT04241276) randomises patients to gemcitabine and nab-paclitaxel with or without all-trans retinoic acid (ATRA), which in preclinical work restores pancreatic stellate cells to quiescence and reduces desmoplasia; the primary endpoint is progression-free survival and the registry lists 170 participants (estimated), a start date of 30 April 2020, primary completion June 2028 and the sponsor as Queen Mary University of London with Barts NHS Trust as the site. The phase 1 STAR_PAC established the dose. No results were published on 24 September 2026; the trial is one of the few UK-led randomised drug trials in pancreatic cancer open in the registry snapshot, beside PRIMUS 001 and the DETERMINE platform.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04241276","url":"https://clinicaltrials.gov/study/NCT04241276"},{"label":"ISRCTN11503604: STARPAC2","url":"https://www.isrctn.com/ISRCTN11503604"}],"tags":[],"related":[],"cancers":["pancreatic","locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel"],"companies":[],"institutions":["barts-cancer-institute"],"pathways":[],"terms":["desmoplasia","pancreatic-trials-open-today"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 1): Barts NHS Trust (London). ISRCTN11503604."],"nct":"NCT04241276","phase":"2","setting":"Pancreatic cancer in the United Kingdom, led from Barts: gemcitabine plus nab-paclitaxel with or without all-trans retinoic acid repurposed as a stroma-targeting agent, a randomised phase 2b with progression-free survival as the primary endpoint","sponsor":"Queen Mary University of London, with the Medical Research Council and Celgene","started":"2020-04-30","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"stars-rosel","kind":"trial","name":"STARS and ROSEL pooled analysis","aka":["STARS","ROSEL","SABR versus lobectomy"],"tldr":"Two small trials that tried to ask whether precision radiotherapy could replace an operation for early lung cancer, closed early because almost nobody would agree to be randomised, and left the question open.","summary":"STARS and ROSEL both randomised patients with operable clinical stage I non-small-cell lung cancer to stereotactic ablative radiotherapy or lobectomy, and both closed early because patients and surgeons would not accept randomisation. Pooling them gave 58 patients, 31 assigned to radiotherapy and 27 to surgery.\n\nAt a median 40.2 months (radiotherapy) and 35.4 months (surgery), estimated three-year overall survival was 95 percent with radiotherapy against 79 percent with surgery (hazard ratio 0.14, 95 percent confidence interval 0.017 to 1.190, log-rank p=0.037), with six deaths in the surgical arm and one in the radiotherapy arm. Three-year recurrence-free survival was 86 against 80 percent (hazard ratio 0.69, p=0.54): the survival difference came from deaths not caused by the cancer. Grade 3 adverse events occurred in 3 of 31 radiotherapy patients and 12 of 27 surgical patients, with one surgical death.\n\nThe authors were explicit that 58 patients and three years cannot change practice, and the result is best read as a reason to run the larger trials (STABLE-MATES, VALOR and SABRTooth) rather than as evidence that radiotherapy is better. For patients who are medically inoperable, stereotactic radiotherapy is already the standard, which CHISEL established against conventional radiotherapy.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00840749","url":"https://clinicaltrials.gov/study/NCT00840749"},{"label":"ClinicalTrials.gov NCT00687986","url":"https://clinicaltrials.gov/study/NCT00687986"},{"label":"STARS and ROSEL pooled analysis (Lancet Oncology 2015)","url":"https://doi.org/10.1016/S1470-2045(15)70168-3"}],"tags":[],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["curative-intent"],"trials":["chisel","jcog0802","calgb-140503"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Operable clinical stage I non-small-cell lung cancer: stereotactic ablative radiotherapy versus lobectomy with mediastinal node dissection or sampling, pooled from two randomised trials that closed early","sponsor":"MD Anderson Cancer Center (STARS) and VU University Medical Center (ROSEL)","result":"Pooled three-year overall survival 95 percent with stereotactic radiotherapy against 79 percent with surgery (hazard ratio 0.14, p=0.037) in 58 patients; recurrence-free survival not significantly different.","yearReported":2015,"enrolled":58,"enrolledBasis":"randomised","enrolledNote":"58 patients were randomised across the two trials before both closed early for slow accrual; the registry figures for NCT00840749 and NCT00687986 are the planned targets.","outcomes":[],"replication":"Not replicated; the larger randomised comparisons are still running. CHISEL separately showed stereotactic radiotherapy beats conventional radiotherapy in inoperable stage I disease."},{"id":"start-a","kind":"trial","name":"START-A (UK Standardisation of Breast Radiotherapy, trial A)","aka":["START A","UK START trial A"],"tldr":"START-A is the dose-finding half of the British experiment that shortened breast radiotherapy. By giving thirteen larger treatments over the same five weeks at two different total doses, it measured how sensitive breast cancer is to the size of each dose, and the answer is what made three weeks and later one week possible.","summary":"START-A and START-B were run together in 35 United Kingdom radiotherapy centres from 1999 to 2002. START-A kept the overall time at five weeks and varied only the fraction size, comparing 41.6 Gy or 39 Gy in thirteen fractions against the international standard of 50 Gy in twenty-five. Holding the time constant is what makes it a radiobiology experiment rather than a convenience trial: it isolates the effect of fraction size.\n\nAt a median 9.3 years, 139 local-regional relapses had occurred among the 2,236 women. Ten-year local-regional relapse was 6.3 percent with 41.6 Gy (95 percent confidence interval 4.7 to 8.5) against 7.4 percent with 50 Gy (5.5 to 10.0), a hazard ratio of 0.91 (0.59 to 1.38, p=0.65), and 8.8 percent with 39 Gy (6.7 to 11.4), a hazard ratio of 1.18 (0.79 to 1.76, p=0.41). Moderate or marked breast induration, telangiectasia and breast oedema were significantly less common after 39 Gy than after 50 Gy; normal-tissue effects after 41.6 Gy and 50 Gy did not differ.\n\nThe number that mattered is the one the two doses bracket. Tumour control was slightly better at 41.6 Gy and slightly worse at 39 Gy, while normal tissue improved steadily as the dose fell, which means breast cancer responds to fraction size much as normal breast tissue does. That sensitivity, a low alpha to beta ratio, is the physics behind START-B's 40 Gy in fifteen fractions and FAST-Forward's 26 Gy in five.","status":"positive","asOf":"2026-09-25","links":[{"label":"ISRCTN59368779","url":"https://www.isrctn.com/ISRCTN59368779"},{"label":"START ten-year results (Lancet Oncology 2013)","url":"https://doi.org/10.1016/S1470-2045(13)70386-3"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["hypofractionated-radiotherapy","imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":["icr-london"],"pathways":[],"terms":["hypofractionation","alpha-beta-ratio"],"trials":["start-b","fast-trial","fast-forward"],"people":[],"bottlenecks":[],"keyPapers":["paper-haviland-lancet-oncol"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Completely excised invasive breast cancer, pT1 to pT3a, pN0 to pN1, M0, after breast-conserving surgery or mastectomy: 41.6 Gy or 39 Gy in thirteen fractions over five weeks against 50 Gy in twenty-five fractions over five weeks, with local-regional relapse and late normal-tissue effects as the primary endpoints","sponsor":"Institute of Cancer Research, United Kingdom","result":"Ten-year local-regional relapse 6.3 percent with 41.6 Gy in thirteen fractions, 8.8 percent with 39 Gy and 7.4 percent with 50 Gy in twenty-five, with fewer late normal-tissue effects at 39 Gy.","yearReported":2013,"enrolled":2236,"enrolledBasis":"randomised","enrolledNote":"START-A randomised 2,236 women from 1999 to 2002. START-A and START-B were registered together under ISRCTN59368779, so the registration number does not separate the two trials.","outcomes":[{"endpoint":"Local-regional relapse at 10 years","primary":true,"unit":"%","arms":[{"name":"41.6 Gy in 13 fractions","value":6.3,"note":"95 percent confidence interval 4.7 to 8.5"},{"name":"39 Gy in 13 fractions","value":8.8,"note":"95 percent confidence interval 6.7 to 11.4"},{"name":"50 Gy in 25 fractions","value":7.4,"note":"95 percent confidence interval 5.5 to 10.0"}],"source":"https://doi.org/10.1016/S1470-2045(13)70386-3"}],"replication":"START-B, run in the same centres, tested 40 Gy in fifteen fractions over three weeks and became the United Kingdom standard; FAST and FAST-Forward pushed the same radiobiology to five fractions."},{"id":"start-b","kind":"trial","name":"START-B (UK Standardisation of Breast Radiotherapy)","aka":[],"tldr":"START-B showed that three weeks of breast radiotherapy in larger daily doses controls the cancer as well as five weeks of smaller ones, with fewer late changes to the breast, and made 40 Gy in 15 fractions the UK standard.","summary":"START-B randomised 2,215 women with early breast cancer to 40 Gy in 15 fractions or the international standard of 50 Gy in 25. At ten years, local-regional relapse was 4.3 percent with the shorter schedule and 5.5 percent with the standard one, and moderate or marked late normal-tissue effects were less frequent after 40 Gy (Haviland and colleagues, Lancet Oncology 2013, following the 2008 Lancet report). Together with START-A it established that breast cancer is as sensitive to fraction size as normal tissue, the radiobiological basis for hypofractionation.","status":"positive","asOf":"2026-09-16","links":[{"label":"ISRCTN59368779","url":"https://www.isrctn.com/ISRCTN59368779"},{"label":"Lancet Oncology 2013","url":"https://doi.org/10.1016/S1470-2045(13)70386-3"}],"tags":["radiation-wave2"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive","tnbc","breast-cancer"],"sections":[],"technologies":["hypofractionated-radiotherapy","imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":["icr-london"],"pathways":[],"terms":["hypofractionation","alpha-beta-ratio","partial-breast-irradiation"],"trials":["start-a","fast-trial"],"people":[],"bottlenecks":[],"keyPapers":["paper-haviland-lancet-oncol"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Early breast cancer after surgery: 40 Gy in 15 fractions over three weeks versus 50 Gy in 25 fractions over five weeks","sponsor":"Institute of Cancer Research (UK)","result":"10-year local-regional relapse 4.3% vs 5.5%; fewer late normal-tissue effects with 40 Gy in 15 fractions.","yearReported":2008,"enrolled":2215,"enrolledBasis":"registry","outcomes":[{"endpoint":"Local-regional relapse at 10 years","primary":true,"unit":"%","arms":[{"name":"40 Gy in 15 fractions","n":1110,"value":4.3},{"name":"50 Gy in 25 fractions","n":1105,"value":5.5}]}]},{"id":"nct06975293","kind":"trial","name":"STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas","aka":[],"tldr":"A phase 1/2 trial of Toripalimab in sarcomas and uterine sarcoma, run by STORM Therapeutics LTD, now recruiting.","summary":"STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas is a phase 1/2 interventional study registered as NCT06975293 by STORM Therapeutics LTD, with 107 participants planned, started 2025-05-05 and due to reach its primary completion in 2027-12-29. Interventions recorded: STC-15 in combination with toripalimab and STC-15 monotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06975293","url":"https://clinicaltrials.gov/study/NCT06975293"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma","uterine-sarcoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":["coherus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06975293","phase":"1/2","setting":"Open-label, Non-randomized, Multi-cohort, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of STC-15 (a METTL3 Inhibitor) as a Part of Combination Therapy With Toripalimab in Participants With Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas","sponsor":"STORM Therapeutics LTD","started":"2025-05-05","startedType":"actual","enrolled":107,"enrolledBasis":"registry","outcomes":[]},{"id":"stellar","kind":"trial","name":"STELLAR","aka":[],"tldr":"STELLAR is the small single-arm study behind the device approval of tumour treating fields in mesothelioma.","summary":"STELLAR, trial NCT02397928 sponsored by Novocure and reported in 2019, is the small single-arm phase 2 behind the device approval of tumour treating fields in unresectable pleural mesothelioma. It gave 80 patients TTFields at 150 kHz with first-line platinum and pemetrexed and reported longer median survival than a historical chemotherapy control, leading to FDA approval under a Humanitarian Device Exemption in May 2019. OnCo links it to mesothelioma, tumour treating fields, the Optune device record and pemetrexed. There is no randomised confirmation, the exemption pathway carries limited evidence requirements for a rare disease, and whether the device adds anything beyond chemotherapy is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02397928","url":"https://clinicaltrials.gov/study/NCT02397928"}],"tags":[],"related":[],"cancers":["mesothelioma"],"sections":[],"technologies":["ttfields"],"targets":[],"drugs":["optune","pemetrexed"],"companies":["novocure"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02397928","phase":"2","setting":"Unresectable pleural mesothelioma, first line: TTFields (150 kHz) + platinum-pemetrexed, single arm","sponsor":"Novocure","result":"Median OS 18.2 months (single arm) vs 12.1 historical.","started":"2015-02","startedType":"actual","yearReported":2019,"enrolled":82,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (single arm vs historical)","unit":"months","arms":[{"name":"TTFields + chemotherapy","n":80,"value":18.2},{"name":"Historical chemotherapy control","value":12.1}],"source":"https://doi.org/10.1016/S1470-2045(19)30532-7"}],"replication":"Not replicated in a randomised trial; HDE approval is for a rare disease with limited evidence requirements."},{"id":"stellar-rectal","kind":"trial","name":"STELLAR (rectal cancer)","aka":["STELLAR"],"tldr":"China's answer to the same question as RAPIDO: one week of radiotherapy followed by chemotherapy matched five weeks of chemoradiotherapy, with more short-term toxicity.","summary":"STELLAR randomised 599 patients with locally advanced rectal cancer to short-course radiotherapy (25 Gy in five fractions) followed by four cycles of CAPOX and then surgery with two more cycles, or to chemoradiotherapy (50 Gy in 25 fractions with capecitabine) then surgery and six cycles of CAPOX. Three-year disease-free survival was 64.5 against 62.3 percent (hazard ratio 0.883, upper bound of the one-sided 95% CI 1.11, within the non-inferiority margin). Acute grade III to V toxicity during preoperative treatment was 26.5 against 12.6 percent. Overall survival favoured the total neoadjuvant arm (p=0.033). STELLAR and RAPIDO together made short-course radiotherapy followed by consolidation chemotherapy an accepted schedule outside northern Europe.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02533271","url":"https://clinicaltrials.gov/study/NCT02533271"},{"label":"STELLAR: short-term radiotherapy plus chemotherapy versus long-term chemoradiotherapy in locally advanced rectal cancer (Journal of Clinical Oncology 2022)","url":"https://doi.org/10.1200/JCO.21.01667"}],"tags":[],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["imrt-igrt","cytotoxic-chemotherapy"],"targets":[],"drugs":["capox","capecitabine","oxaliplatin"],"companies":[],"institutions":[],"pathways":[],"terms":["chemoradiation"],"trials":["rapido","stockholm-iii"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02533271","phase":"3","setting":"Distal or middle-third, cT3-4 or node-positive rectal cancer: short-course radiotherapy then four cycles of CAPOX (total neoadjuvant therapy) against long-course chemoradiotherapy","sponsor":"Chinese Academy of Medical Sciences","result":"Three-year disease-free survival 64.5 against 62.3 percent, non-inferior; more acute toxicity before surgery.","started":"2015-08","yearReported":2022,"enrolled":599,"enrolledBasis":"randomised","enrolledNote":"The registry lists a target of 600; 599 patients were randomised between August 2015 and August 2018.","outcomes":[{"endpoint":"Disease-free survival at 3 years","primary":true,"unit":"percent","arms":[{"name":"Short-course radiotherapy then chemotherapy","n":302,"value":64.5},{"name":"Long-course chemoradiotherapy","n":297,"value":62.3}],"hr":0.883,"source":"https://doi.org/10.1200/JCO.21.01667"}],"replication":"Consistent with RAPIDO's reduction in disease-related treatment failure using the same schedule."},{"id":"nct02730299","kind":"trial","name":"Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS","aka":[],"tldr":"A phase 3 trial of Omidubicel in Acute lymphoblastic leukaemia and Leukaemia, run by Gamida Cell ltd, completed.","summary":"Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS is a phase 3 interventional study registered as NCT02730299 by Gamida Cell ltd, with 125 participants recorded, started 2016-12-16 and reaching its primary completion in 2021-04-29. Interventions recorded: NiCord® (omidubicel), Cord Blood Unit. Conditions recorded: Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia (CML), Myelodysplastic Syndrome (MDS), Lymphoma, Acute Leukemia.\n\nLinked to the drug Omidubicel because the registry names it among its interventions and Acute lymphoblastic leukaemia and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02730299","url":"https://clinicaltrials.gov/study/NCT02730299"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["omidubicel"],"companies":["gamida-cell"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02730299","phase":"3","setting":"A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, UCB-derived, Stem and Progenitor Cells, vs. Unmanipulated UCB for Patients With Hematological Malignancies","sponsor":"Gamida Cell ltd","started":"2016-12-16","startedType":"actual","yearReported":2022,"enrolled":125,"enrolledBasis":"registry","outcomes":[{"endpoint":"Time to Neutrophil Engraftment","primary":true,"unit":"days","arms":[{"name":"NiCord® (Omidubicel)","n":62,"value":12,"note":"95% CI 10 to 14; Figures from the ClinicalTrials.gov results section (first posted 2022-10-25), not from a publication"},{"name":"Unmanipulated Cord Blood Unit(s)","n":63,"value":22,"note":"95% CI 19 to 25"}],"source":"https://clinicaltrials.gov/study/NCT02730299?tab=results"}]},{"id":"nct06563388","kind":"trial","name":"Stereotactic Ablative Radiotherapy (SABR) for the Treatment of Patients With Metastatic Cancer, ID-COMET Trial","aka":["ID-COMET"],"tldr":"A phase 3 trial in colorectal cancer, run by Roswell Park Cancer Institute, now recruiting.","summary":"Stereotactic Ablative Radiotherapy (SABR) for the Treatment of Patients With Metastatic Cancer, ID-COMET Trial is a phase 3, randomised interventional study registered as NCT06563388 by Roswell Park Cancer Institute, with a registry enrolment figure of 800 participants, started 2024-09-18 and due to reach its primary completion in 2032-09-18. Interventions recorded: Stereotactic Ablative Radiotherapy; Best Practice. Conditions listed: Oligometastasis; Lung Cancer; Colo-rectal Cancer; Prostate Cancer. Primary outcome: Overall Survival - Trial 1 and 2; Androgen DeprivationTherapy (ADT)-free survival - Trial 3. Colorectal eligibility wording from the registry: \"* Trials 1-3: Histologically confirmed lung, prostate or colorectal malignancy with metastatic disease detected on imaging\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06563388","url":"https://clinicaltrials.gov/study/NCT06563388"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06563388","phase":"3","setting":"(ID-COMET) A Randomized Phase III Trial of Immediate Versus Six-Month Delayed Comprehensive Treatment of 1-10 Oligometastatic Tumors With or Without Synchronous Primary","sponsor":"Roswell Park Cancer Institute","started":"2024-09-18","startedType":"actual","enrolled":800,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02185443","kind":"trial","name":"Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by University of Sao Paulo, now recruiting.","summary":"Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases is a phase 2, interventional study registered as NCT02185443 by University of Sao Paulo, with a registry enrolment figure of 43 participants, started 2014-05 and due to reach its primary completion in 2026-12. Interventions recorded: SBRT. Conditions listed: Liver Metastases; Colorectal Cancer; Anal Canal Cancer; Gastrointestinal Neuroendocrine Tumors. Primary outcome: Local Progression Free Survival. Colorectal eligibility wording from the registry: \"* Histology of the primary tumor: colorectal adenocarcinoma, carcinoma of the anal canal or gastrointestinal neuroendocrine tumors\". Sites: Brazil. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02185443","url":"https://clinicaltrials.gov/study/NCT02185443"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02185443","phase":"2","setting":"Stereotactic Body Radiation Therapy for the Treatment of Unresectable Liver Metastases in Patients With Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors","sponsor":"University of Sao Paulo","started":"2014-05","enrolled":43,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06260033","kind":"trial","name":"Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer","aka":[],"tldr":"A phase 2 trial of Fluoroestradiol F-18 in Breast cancer, run by City of Hope Medical Center, now recruiting.","summary":"Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer is a phase 2 interventional study registered as NCT06260033 by City of Hope Medical Center, with 18 participants planned, started 2024-07-23 and due to reach its primary completion in 2026-10-29. Interventions recorded: Biospecimen Collection, Bone Scan, Computed Tomography, F-18 16 Alpha-Fluoroestradiol, Positron Emission Tomography, Questionnaire Administration, Stereotactic Body Radiation Therapy. Conditions recorded: Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma, Metastatic Breast Carcinoma.\n\nLinked to the drug Fluoroestradiol F-18 because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06260033","url":"https://clinicaltrials.gov/study/NCT06260033"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["fluoroestradiol-f18"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06260033","phase":"2","setting":"A Phase II Trial of Stereotactic Body Radiation Therapy and Fluoroestradiol Positron Emission Tomography in Patients With Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer","sponsor":"City of Hope Medical Center","started":"2024-07-23","startedType":"actual","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06259058","kind":"trial","name":"Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of liposomal irinotecan, cAPOX (capecitabine, oxaliplatin), fluorouracil (5-FU) and fLOT (5-FU, leucovorin, oxaliplatin, docetaxel) in pancreatic cancer, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer is a phase 1/2, randomised interventional study registered as NCT06259058 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 96 participants, started 2024-04-01 and due to reach its primary completion in 2026-04-01. Interventions recorded: Irinotecan liposome injection; Oxaliplatin; 5-Fluorouracil; Leucovorin; SBRT. Conditions listed: Pancreatic Cancer. Primary outcome: R0 resection rate. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically proven pancreatic ductal adenocarcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06259058","url":"https://clinicaltrials.gov/study/NCT06259058"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","sbrt","topoisomerase-inhibitors"],"targets":[],"drugs":["liposomal-irinotecan","capox","fluorouracil","flot"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06259058","phase":"1/2","setting":"Evaluate the Efficacy and Safety of Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer: a Phase Ib/II, Multicenter, Open-label Trial","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2024-04-01","startedType":"estimated","enrolled":96,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07297004","kind":"trial","name":"Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, now recruiting.","summary":"Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer is a phase 2, interventional study registered as NCT07297004 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 20 participants, started 2025-01-01 and due to reach its primary completion in 2026-11-30. Interventions recorded: Stereotactic Body Radiation Therapy (SBRT). Conditions listed: Unresectable Locally Recurrent Rectal Cancer. Primary outcome: 1-year local progression-free survival (LPFS). Colorectal eligibility wording from the registry: \"No clear distant metastasis at the time of diagnosis of locally recurrent rectal adenocarcinoma or MDT assesses that oligometastatic lesions are resectable or controlable (UICC 8th edition);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07297004","url":"https://clinicaltrials.gov/study/NCT07297004"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07297004","phase":"2","setting":"Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer: A Prospective, Single-arm, Phase II Study","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2025-01-01","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06598527","kind":"trial","name":"Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy Versus Tislelizumab Plus Platinum-based Chemotherapy as Neoadjuvant The","aka":["SACTION2401"],"tldr":"A phase 3 trial of tislelizumab in lung cancer, run by Yang Hong, now recruiting.","summary":"Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy Versus Tislelizumab Plus Platinum-based Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage II-III Non-small Cell Lung Cancer: A Phase III, Randomized, Multicenter, Prospective Study is a phase 3, randomised interventional study registered as NCT06598527 by Yang Hong, with a registry enrolment figure of 360 participants, started 2024-10-15 and due to reach its primary completion in 2027-01-30. Interventions recorded: Stereotactic body radiotherapy (SBRT); Tislelizumab; Chemotherapy. Conditions listed: Lung Cancer (NSCLC). Primary outcome: event-free survival. Lung eligibility wording from the registry: \"Patients with cytologically/histologically diagnosed (by means of percutaneous lung aspiration biopsy, bronchoscopy, mediastinoscopy, etc\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06598527","url":"https://clinicaltrials.gov/study/NCT06598527"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","sbrt"],"targets":[],"drugs":["tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06598527","phase":"3","setting":"Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy Versus Tislelizumab Plus Platinum-based Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage II-III Non-small Cell Lung Cancer: A Phase III, Randomized, Multicenter, Prospective Study","sponsor":"Yang Hong","started":"2024-10-15","startedType":"actual","enrolled":360,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06523673","kind":"trial","name":"Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer","aka":["OPPRESS"],"tldr":"A phase 3 trial in lung cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT06523673 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 104 participants, started 2024-09 and due to reach its primary completion in 2027-09. Interventions recorded: Stereotactic Body Radiotherapy; second-line systemic therapy. Conditions listed: Metastatic Non-Small Cell Lung Cancer; NSCLC Stage IV; OligoProgressive Metastatic Disease. Primary outcome: progression-free survival (PFS). Lung eligibility wording from the registry: \"* Histologically and/or cytologically confirmed stage IV metastatic NSCLC\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06523673","url":"https://clinicaltrials.gov/study/NCT06523673"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06523673","phase":"3","setting":"Stereotactic Body Radiotherapy (SBRT) for Oligo-Progression During First-Line Chemotherapy in Metastatic Non-Small Cell Lung Cancer (OPPRESS):A Randomized, Controlled, Open-label, Multi-Center Phase 3 Study","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2024-09","startedType":"estimated","enrolled":104,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07126158","kind":"trial","name":"Stereotactic Body Radiotherapy Plus FAK and RAF/MEK Inhibition in Advanced Pancreatic Adenocarcinoma","aka":[],"tldr":"A phase 2 trial of avutometinib + defactinib in pancreatic cancer, run by Washington University School of Medicine, now recruiting.","summary":"Stereotactic Body Radiotherapy Plus FAK and RAF/MEK Inhibition in Advanced Pancreatic Adenocarcinoma is a phase 2, randomised interventional study registered as NCT07126158 by Washington University School of Medicine, with a registry enrolment figure of 36 participants, started 2026-04-10 and due to reach its primary completion in 2030-04-30. Interventions recorded: Stereotactic body radiotherapy; Defactinib; Avutometinib. Conditions listed: Pancreatic Adenocarcinoma; Cancer of the Pancreas; Pancreas Cancer; Pancreatic Cancer. Primary outcome: Progression-free survival (PFS) - Experimental Arm Only. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is considered borderline resectable or locally advanced per institutional standardized criteria of unresectability or medical inoperability (NCCN guidelines 2\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07126158","url":"https://clinicaltrials.gov/study/NCT07126158"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac","locally-advanced-pdac"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":["avutometinib-defactinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07126158","phase":"2","setting":"Phase II Study of Stereotactic Body Radiotherapy Plus FAK and RAF/MEK Inhibition in Advanced Pancreatic Adenocarcinoma","sponsor":"Washington University School of Medicine","started":"2026-04-10","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04899908","kind":"trial","name":"Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Brigham and Women's Hospital, now recruiting.","summary":"Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases is a phase 2, randomised interventional study registered as NCT04899908 by Brigham and Women's Hospital, with a registry enrolment figure of 134 participants, started 2021-09-15 and due to reach its primary completion in 2028-04. Interventions recorded: Stereotactic Radiation; AGuIX gadolinium-based nanoparticles; Placebo. Conditions listed: Brain Cancer; Brain Metastases; Melanoma; Lung Cancer; Breast Cancer; HER2-positive Breast Cancer; Colorectal Cancer; Gastrointestinal Cancer; SRS; SRT; Whole Brain Radiation; Stereotactic Radiation; AGuIX; Nanoparticle; Cystic; Brain Tumor. Primary outcome: Local Recurrence. Colorectal eligibility wording from the registry: \"* Locally recurrent metastases after prior whole brain radiation \\*Patients with metastases from melanoma, GI primaries, or HER2+ breast cancer, as well as those with cystic metastases or metastases ≥2cm in maximal unidimensional size, who have local recurrences after prior brain-directed radiation \". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04899908","url":"https://clinicaltrials.gov/study/NCT04899908"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","her2-amplified-colorectal"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04899908","phase":"2","setting":"A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone","sponsor":"Brigham and Women's Hospital","started":"2021-09-15","startedType":"actual","enrolled":134,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07132190","kind":"trial","name":"Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Ayal A. Aizer, MD, now recruiting.","summary":"Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction is a phase 2, randomised interventional study registered as NCT07132190 by Ayal A. Aizer, MD, with a registry enrolment figure of 60 participants, started 2025-12-30 and due to reach its primary completion in 2028-09. Interventions recorded: Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV. Conditions listed: Brain Metastases, Adult; Brain Tumor - Metastatic; Brain Metastases From Non-small Cell Lung Cancer (NSCLC); Brain Metastases From Extra-cranial Solid Tumors. Primary outcome: To assess the percentage of patients that demonstrate tumor beyond the standard planning margin (1.0mm PTV) at the time of stereotactic treatment.. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07132190","url":"https://clinicaltrials.gov/study/NCT07132190"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":["siemens-healthineers"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07132190","phase":"2","setting":"A Double-Blind Phase II Randomized Study of Adaptively Delivered LINAC-Based Stereotactic Radiation for Volatile Brain Metastases With Same-Day Planning and Margin Reduction","sponsor":"Ayal A. Aizer, MD","started":"2025-12-30","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06165900","kind":"trial","name":"Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC","aka":[],"tldr":"A phase 2 trial of adebrelimab and carboplatin in triple-negative breast cancer, run by Shengjing Hospital, now recruiting.","summary":"Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC is a phase 2, randomised interventional study registered as NCT06165900 by Shengjing Hospital, with a registry enrolment figure of 136 participants, started 2023-09-26 and due to reach its primary completion in 2025-12-15. Interventions recorded: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin); adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin). Conditions listed: Stereotactic Radiotherapy; Immunotherapy; Breast Cancer. Triple-negative eligibility wording from the registry: \"* Histopathologically confirmed early or locally advanced triple-negative invasive breast cancer according to the latest ASCO/CAP guidelines, meeting the following conditions: (1) pathological type is triple-negative, specifically: ER negative: IHC \\< 1%, PR negative: IHC \\< 1%, HER2 negative: IHC 0\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06165900","url":"https://clinicaltrials.gov/study/NCT06165900"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["adebrelimab","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06165900","phase":"2","setting":"A Multicenter, Randomized Trial of Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) Versus Adebrelimab Combined With TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of Triple-negative Breast Cancer","sponsor":"Shengjing Hospital","started":"2023-09-26","startedType":"actual","enrolled":136,"enrolledBasis":"registry","outcomes":[]},{"id":"stevie","kind":"trial","name":"STEVIE (vismodegib in ordinary practice)","aka":["STEVIE","Safety Events in Vismodegib study"],"tldr":"This is the study that measured what taking the basal cell carcinoma pill is actually like, in more than a thousand ordinary patients rather than a hundred selected ones. It shrank most tumours. Almost everybody had side effects, and the average person stopped after about eight months.","summary":"ERIVANCE licensed vismodegib on 104 patients. STEVIE was built to find out what happens when the same drug is given to everyone who might need it: 1,215 evaluable adults in 36 countries, 1,119 with locally advanced and 96 with metastatic basal cell carcinoma, treated with 150 mg daily until progression or intolerance. Safety was the primary objective, which is unusual and is the point.\n\nThe efficacy held. Investigator-assessed objective response was 68.5 per cent in locally advanced disease (95 per cent confidence interval 65.7 to 71.3) and 36.9 per cent in metastatic disease (26.6 to 48.1).\n\nThe tolerability is the finding. Ninety-eight per cent of patients had at least one treatment-emergent adverse event and 289 (23.8 per cent) had a serious one. The median treatment duration was 8.6 months, with a range from zero to 44, and only 147 patients (12 per cent) were still on the drug when the analysis was done. The characteristic events are not dangerous but do not settle, and they affect everything a person does: muscle spasms, loss of taste, hair loss and weight loss. Exposure beyond twelve months did not make them worse or more frequent, and most of the common events that were ongoing when treatment stopped had resolved within twelve months afterwards, which matters for anyone considering a planned break.\n\nThis is why drug holidays and intermittent schedules were tested, why a topical hedgehog inhibitor was developed, and why the second line for basal cell carcinoma is a PD-1 antibody rather than another pill down the same pathway.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01367665","url":"https://clinicaltrials.gov/study/NCT01367665"},{"label":"Primary analysis (European Journal of Cancer 2017)","url":"https://doi.org/10.1016/j.ejca.2017.08.022"},{"label":"Primary analysis on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/29073584/"}],"tags":[],"related":[],"cancers":["basal-cell-carcinoma","locally-advanced-bcc","skin-cancer"],"sections":[],"technologies":["hedgehog-inhibitors"],"targets":["smoothened"],"drugs":["vismodegib"],"companies":["roche-genentech"],"institutions":[],"pathways":["hedgehog"],"terms":["hedgehog-inhibitor-tolerability"],"trials":["erivance","bolt","vismoneo","cemiplimab-advanced-bcc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01367665","phase":"2","setting":"Locally advanced or metastatic basal cell carcinoma in a population representative of clinical practice rather than of a pivotal trial: oral vismodegib 150 mg daily until progression, unacceptable toxicity or withdrawal, with safety as the primary objective","sponsor":"F. Hoffmann-La Roche","result":"Investigator-assessed response 68.5 per cent in locally advanced and 36.9 per cent in metastatic basal cell carcinoma, with treatment-emergent adverse events in 98 per cent, serious events in 23.8 per cent and a median treatment duration of 8.6 months.","started":"2011-07-01","startedType":"actual","yearReported":2017,"enrolled":1215,"enrolledBasis":"treated","enrolledNote":"1,215 evaluable adults from 36 countries were treated and are the population of the primary analysis; the ClinicalTrials.gov record NCT01367665 gives an enrolment of 1,232.","outcomes":[{"endpoint":"Objective response rate, locally advanced basal cell carcinoma (investigator assessed)","primary":true,"unit":"%","arms":[{"name":"Vismodegib 150 mg daily","n":1119,"value":68.5,"note":"95 per cent confidence interval 65.7 to 71.3"}],"source":"https://doi.org/10.1016/j.ejca.2017.08.022"},{"endpoint":"Objective response rate, metastatic basal cell carcinoma (investigator assessed)","unit":"%","arms":[{"name":"Vismodegib 150 mg daily","n":96,"value":36.9,"note":"95 per cent confidence interval 26.6 to 48.1"}],"source":"https://doi.org/10.1016/j.ejca.2017.08.022"},{"endpoint":"Serious treatment-emergent adverse events","primary":true,"unit":"%","arms":[{"name":"Vismodegib 150 mg daily","n":1215,"value":23.8,"note":"289 of 1,215 patients; any treatment-emergent adverse event in 98 per cent"}],"source":"https://doi.org/10.1016/j.ejca.2017.08.022"},{"endpoint":"Median duration of treatment","unit":"months","arms":[{"name":"Vismodegib 150 mg daily","n":1215,"value":8.6,"note":"range 0 to 44; 147 patients (12 per cent) still on study at the analysis"}],"source":"https://doi.org/10.1016/j.ejca.2017.08.022"}],"replication":"The Italian cohort of 182 patients within STEVIE reported the same pattern separately, with an overall response rate of 67.1 per cent in locally advanced disease and adverse events at the same incidence as the whole population (Future Oncology 2020, PubMed 32374193)."},{"id":"nct05241249","kind":"trial","name":"Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic Adenocarcinoma","aka":[],"tldr":"A phase 2 trial of gemcitabine and nab-paclitaxel in pancreatic cancer, run by Susan E. Bates, now recruiting.","summary":"Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic Adenocarcinoma is a phase 2, interventional study registered as NCT05241249 by Susan E. Bates, with a registry enrolment figure of 37 participants, started 2022-02-01 and due to reach its primary completion in 2026-01. Interventions recorded: Bethanechol; Gemcitabine; nab-paclitaxel. Conditions listed: Pancreas Cancer. Primary outcome: R0 resection rate. Pancreatic eligibility wording from the registry: \"* Pancreatic Ductal Adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05241249","url":"https://clinicaltrials.gov/study/NCT05241249"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05241249","phase":"2","setting":"Phase II, Neoadjuvant Study of Parasympathetic Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Borderline Resectable Pancreatic Adenocarcinoma","sponsor":"Susan E. Bates","started":"2022-02-01","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"stockholm-iii","kind":"trial","name":"Stockholm III","aka":[],"tldr":"Waiting four to eight weeks after a short course of radiotherapy is as safe as operating immediately, and it gives time for the tumour to shrink.","summary":"Stockholm III randomised 840 patients from eighteen Swedish hospitals between short-course radiotherapy with immediate surgery, short-course radiotherapy with surgery delayed four to eight weeks, and long-course radiotherapy with delayed surgery. Local recurrence occurred in eight of 357, ten of 355 and seven of 128 patients respectively; both delayed arms were non-inferior (hazard ratio for short-course with delay 1.44, 95% CI 0.41 to 5.11; for long-course with delay 2.24, 0.71 to 7.10; p=0.48). Postoperative complications were fewer with delay. The trial made the delayed short course a legitimate option, which is what RAPIDO and STELLAR then built their total neoadjuvant schedules on and what allows organ preservation after a one-week course.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00904813","url":"https://clinicaltrials.gov/study/NCT00904813"},{"label":"Stockholm III: optimal fractionation of preoperative radiotherapy and timing to surgery for rectal cancer (Lancet Oncology 2017)","url":"https://doi.org/10.1016/S1470-2045(17)30086-4"}],"tags":[],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":["karolinska"],"pathways":[],"terms":[],"trials":["rapido","stellar-rectal"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00904813","phase":"3","setting":"Resectable rectal cancer: 5 x 5 Gy with surgery within a week, 5 x 5 Gy with surgery after four to eight weeks, or 25 x 2 Gy with delayed surgery","sponsor":"Karolinska Institutet","result":"Delaying surgery after 5 x 5 Gy is non-inferior for local recurrence and has fewer postoperative complications.","started":"1998-11","yearReported":2017,"enrolled":840,"enrolledBasis":"registry","outcomes":[{"endpoint":"Local recurrence","primary":true,"unit":"events","arms":[{"name":"Short-course, immediate surgery","n":357,"value":8},{"name":"Short-course, delayed surgery","n":355,"value":10},{"name":"Long-course, delayed surgery","n":128,"value":7}],"p":"0.48","source":"https://doi.org/10.1016/S1470-2045(17)30086-4"}]},{"id":"stomp-oligorecurrence","kind":"trial","name":"STOMP","aka":["STOMP","Surveillance or Metastasis-directed Therapy for Oligometastatic Prostate cancer recurrence"],"tldr":"Zapping the handful of spots that show up when prostate cancer comes back put off the day hormone therapy was needed, by about eight months, in a small trial.","summary":"STOMP randomised 62 men with asymptomatic biochemical recurrence and three or fewer extracranial metastases on choline PET-CT to surveillance or metastasis-directed therapy of all detected lesions by surgery or stereotactic body radiotherapy. Randomisation was balanced on PSA doubling time (3 months or less against more than 3) and on nodal against non-nodal metastases. Androgen deprivation was started at symptomatic progression, progression to more than three metastases, or local progression of known metastases.\n\nAt a median 3 years (interquartile range 2.3 to 3.75), median androgen deprivation-free survival was 13 months (80 percent confidence interval 12 to 17) with surveillance and 21 months (80 percent confidence interval 14 to 29) with metastasis-directed therapy, hazard ratio 0.60 (80 percent confidence interval 0.40 to 0.90, log-rank p=0.11). The 80 percent confidence interval is what the trial was designed to report and is much wider than the conventional 95 percent.\n\nQuality of life was similar between arms at baseline, 3 months and 1 year. Six men in the treatment arm had grade 1 toxicity and no grade 2 to 5 toxicity was observed.\n\nSTOMP is a signal, not a proof. It changed practice anyway, partly because PSMA PET made small-volume recurrence visible in far more men, and the phase 3 trials that should settle it are still running.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01558427","url":"https://clinicaltrials.gov/study/NCT01558427"},{"label":"STOMP (Journal of Clinical Oncology 2018)","url":"https://doi.org/10.1200/JCO.2017.75.4853"}],"tags":[],"related":[],"cancers":["prostate","prostate-bcr","prostate-mhspc"],"sections":[],"technologies":["sbrt","sabr-oligometastases","robotic-surgery"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["oligometastatic","biochemical-recurrence","adt","psa-kinetics"],"trials":["oriole","sabr-comet"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01558427","phase":"2","setting":"Asymptomatic biochemical recurrence after treatment with curative intent, three or fewer extracranial metastases on choline PET-CT and serum testosterone above 50 ng/mL: surveillance against metastasis-directed therapy to all detected lesions by surgery or stereotactic body radiotherapy, with androgen deprivation-free survival as the primary endpoint","sponsor":"Ghent University Hospital","result":"Median androgen deprivation-free survival 21 months with metastasis-directed therapy against 13 months with surveillance (hazard ratio 0.60, 80 percent confidence interval 0.40 to 0.90, p=0.11); no grade 2 or worse toxicity.","started":"2012-08-01","startedType":"actual","yearReported":2018,"enrolled":62,"enrolledBasis":"randomised","enrolledNote":"62 men were enrolled between August 2012 and August 2015; the trial is a randomised phase 2, powered for a signal rather than a definitive answer.","outcomes":[{"endpoint":"Androgen deprivation-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Metastasis-directed therapy","value":21,"note":"Confidence intervals were prespecified at 80 percent: 14 to 29 and 12 to 17 months, hazard ratio 0.40 to 0.90."},{"name":"Surveillance","value":13}],"hr":0.6,"p":"0.11","source":"https://doi.org/10.1200/JCO.2017.75.4853"}],"replication":"ORIOLE (54 men) found progression at 6 months in 19 percent after stereotactic radiotherapy against 61 percent under observation (p=0.005); no phase 3 trial has yet reported a survival benefit."},{"id":"strass","kind":"trial","name":"STRASS (EORTC 62092)","aka":[],"tldr":"The first randomised trial in retroperitoneal sarcoma found that radiotherapy before surgery did not reduce recurrence in the abdomen, ending a decades-long debate for most patients.","summary":"STRASS, EORTC 62092, randomised 266 patients with primary resectable retroperitoneal sarcoma across European and North American sarcoma centres to preoperative radiotherapy followed by surgery or surgery alone. Its primary endpoint of abdominal recurrence-free survival was not improved by radiotherapy, and preoperative treatment added toxicity and delayed surgery. An unplanned subgroup analysis suggested a benefit in well-differentiated and low-grade dedifferentiated liposarcoma, which continues to be studied but did not change the primary result. Published in Lancet Oncology in 2020, it made surgery alone the standard for most retroperitoneal sarcomas and shifted attention to neoadjuvant chemotherapy (STRASS2).","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01344018","url":"https://clinicaltrials.gov/study/NCT01344018"},{"label":"Lancet Oncology 2020","url":"https://doi.org/10.1016/S1470-2045(20)30446-0"}],"tags":["subtype-page"],"related":[],"cancers":["retroperitoneal-sarcoma","liposarcoma","leiomyosarcoma","sarcoma"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01344018","phase":"3","setting":"Primary resectable retroperitoneal sarcoma: preoperative radiotherapy (50.4 Gy) plus surgery versus surgery alone","sponsor":"EORTC","result":"Abdominal recurrence-free survival not improved by preoperative radiotherapy; possible benefit in liposarcoma subgroups only.","started":"2012-01","startedType":"actual","yearReported":2020,"enrolled":266,"enrolledBasis":"registry","outcomes":[{"endpoint":"Abdominal recurrence-free survival (median)","primary":true,"unit":"years","arms":[{"name":"Preoperative radiotherapy + surgery","n":133,"value":4.5,"note":"95% CI 3.9 to not estimable; median follow-up 43.1 months"},{"name":"Surgery alone","n":133,"value":5,"note":"95% CI 3.4 to not estimable"}],"hr":1.01,"ci":[0.71,1.44],"p":"0.95","source":"https://doi.org/10.1016/S1470-2045(20)30446-0"},{"endpoint":"Completed allocated treatment","unit":"%","arms":[{"name":"Preoperative radiotherapy + surgery","n":133,"value":89,"note":"Had both radiotherapy and surgery"},{"name":"Surgery alone","n":133,"value":96,"note":"Had surgery"}],"source":"https://doi.org/10.1016/S1470-2045(20)30446-0"},{"endpoint":"Grade 3-4 lymphopenia","unit":"%","arms":[{"name":"Preoperative radiotherapy + surgery","n":127,"value":77},{"name":"Surgery alone","n":128,"value":1}],"source":"https://doi.org/10.1016/S1470-2045(20)30446-0"},{"endpoint":"Grade 3-4 anaemia","unit":"%","arms":[{"name":"Preoperative radiotherapy + surgery","n":127,"value":12},{"name":"Surgery alone","n":128,"value":8}],"source":"https://doi.org/10.1016/S1470-2045(20)30446-0"},{"endpoint":"Grade 3-4 hypoalbuminaemia","unit":"%","arms":[{"name":"Preoperative radiotherapy + surgery","n":127,"value":12},{"name":"Surgery alone","n":128,"value":4}],"source":"https://doi.org/10.1016/S1470-2045(20)30446-0"},{"endpoint":"Serious adverse events","unit":"%","arms":[{"name":"Preoperative radiotherapy + surgery","n":127,"value":24},{"name":"Surgery alone","n":128,"value":10}],"source":"https://doi.org/10.1016/S1470-2045(20)30446-0"},{"endpoint":"Treatment-related deaths","unit":"%","arms":[{"name":"Preoperative radiotherapy + surgery","n":127,"value":1,"note":"One death from gastropleural fistula"},{"name":"Surgery alone","n":128,"value":0}],"source":"https://doi.org/10.1016/S1470-2045(20)30446-0"}]},{"id":"nct07213570","kind":"trial","name":"STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer","aka":["STREAM-2"],"tldr":"A phase 2 trial of regorafenib in colorectal cancer, run by National Cancer Institute, Naples, now recruiting.","summary":"STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07213570 by National Cancer Institute, Naples, with a registry enrolment figure of 60 participants, started 2025-10-16 and due to reach its primary completion in 2026-10. Interventions recorded: standard second line treatment, at discretion of the investigator; Regorafenib (BAY73-4506). Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Progression Free Survival rate at 6 months in the two arms.. Colorectal eligibility wording from the registry: \"Histologically proven of colorectal adenocarcinoma\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07213570","url":"https://clinicaltrials.gov/study/NCT07213570"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["regorafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07213570","phase":"2","setting":"Regorafenib as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer: a Multicentre, Phase 2 Study","sponsor":"National Cancer Institute, Naples","started":"2025-10-16","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02952885","kind":"trial","name":"Strict IGF-1 Control in Acromegaly","aka":[],"tldr":"A phase 3 trial of Pegvisomant in Pituitary tumours, run by Unity Health Toronto, completed.","summary":"Strict IGF-1 Control in Acromegaly is a phase 3 interventional study registered as NCT02952885 by Unity Health Toronto, with 10 participants recorded, started 2017-07-27 and reaching its primary completion in 2020-05-07. Interventions recorded: Pegvisomant. Conditions recorded: Acromegaly.\n\nLinked to the drug Pegvisomant because the registry names it among its interventions and Pituitary tumours among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02952885","url":"https://clinicaltrials.gov/study/NCT02952885"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pituitary-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["pegvisomant"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02952885","phase":"3","setting":"Strict IGF-1 Control in Acromegaly (I-Con Study)","sponsor":"Unity Health Toronto","started":"2017-07-27","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07007312","kind":"trial","name":"Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML","aka":[],"tldr":"A phase 3 trial of Ziftomenib, Venetoclax, Azacitidine, Daunorubicin and Cytarabine in acute myeloid leukaemia, run by Kura Oncology, Inc., now recruiting.","summary":"Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML is a phase 3 interventional study registered as NCT07007312 by Kura Oncology, Inc., with 1300 participants planned, started 2025-09-26 and due to reach its primary completion in 2031-11. Interventions recorded: Ziftomenib, Placebo, Venetoclax, Azacitidine (AZA), Daunorubicin and Cytarabine (Ara-C).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07007312","url":"https://clinicaltrials.gov/study/NCT07007312"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-npm1-kmt2a"],"sections":[],"technologies":["bcl2-inhibitors","cytotoxic-chemotherapy","epigenetic-drugs","kinase-inhibitors"],"targets":[],"drugs":["ziftomenib","venetoclax","azacitidine","daunorubicin","cytarabine"],"companies":["kura-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07007312","phase":"3","setting":"Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia","sponsor":"Kura Oncology, Inc.","started":"2025-09-26","startedType":"actual","enrolled":1300,"enrolledBasis":"registry","outcomes":[]},{"id":"study-0201","kind":"trial","name":"Study 0201","aka":["0201","MAXIM-MP-MA-0201","CWRU-MAXI-1998","Ceplene pivotal trial"],"tldr":"Study 0201 showed that histamine injections given with low-dose interleukin-2 after consolidation helped more adults with acute myeloid leukaemia in first remission stay free of leukaemia at three years than observation alone, and it was the main evidence for the EU authorisation of Ceplene.","summary":"Study 0201 was a multicentre, randomised, open-label phase 3 trial of post-consolidation immunotherapy with histamine dihydrochloride plus interleukin-2 in adults with acute myeloid leukaemia in complete remission. Three hundred and twenty patients (median age 57 years, range 18 to 84) were stratified by first complete remission or subsequent remission and assigned to histamine dihydrochloride 0.5 mg plus interleukin-2 16,400 units per kilogram, both injected under the skin twice daily for ten 21-day cycles, or to no further therapy. Study arms were balanced for age, sex, previous treatment, karyotype, time from remission to inclusion and secondary leukaemia.\n\nThree years after the last patient was enrolled, leukaemia-free survival was better with histamine plus interleukin-2 than with observation in the full population (n = 320, P less than .01, log-rank). In first complete remission (n = 261), three-year leukaemia-free survival was 40 percent with the combination against 26 percent with observation (P = .01). Side effects were typically mild to moderate (Blood 2006).\n\nThe EMA overview describes one main study of 320 adults with acute myeloid leukaemia in remission, in which Ceplene with interleukin-2 was compared with no treatment. The European Commission authorised Ceplene on 7 October 2008 under exceptional circumstances for maintenance with interleukin-2 in adults in first remission; the marketing authorisation holder is Laboratoires Delbert. The registry records the study as completed under secondary id MAXIM-MP-MA-0201 and posts no results.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00003991","url":"https://clinicaltrials.gov/study/NCT00003991"},{"label":"Blood 2006","url":"https://doi.org/10.1182/blood-2005-10-4073"},{"label":"Ceplene EPAR (EMA)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ceplene"}],"tags":[],"related":[],"cancers":["aml"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["histamine-dihydrochloride","aldesleukin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-study-0201-blood-2006"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003991","phase":"3","setting":"Adults with acute myeloid leukaemia in first or subsequent complete remission after consolidation: histamine dihydrochloride plus low-dose interleukin-2 against no further therapy","sponsor":"Maxim Pharmaceuticals","result":"Leukaemia-free survival improved over observation in the full population (n=320, P<.01); in first complete remission, 3-year leukaemia-free survival 40% with histamine plus interleukin-2 against 26% with observation (P=.01).","started":"1998-07","yearReported":2006,"enrolled":320,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov NCT00003991 posts an estimated enrolment of 360 and no actual count; the Blood 2006 abstract and the EMA overview both count 320 randomised patients.","outcomes":[{"endpoint":"Leukaemia-free survival at 3 years, first complete remission subgroup","unit":"%","arms":[{"name":"Histamine dihydrochloride plus interleukin-2","value":40,"note":"First-remission subgroup (n = 261 across both arms); the primary analysis in all 320 patients reported P < .01 without printed rates"},{"name":"No further therapy (observation)","value":26}],"p":"0.01","source":"https://doi.org/10.1182/blood-2005-10-4073"}]},{"id":"study-2005-01","kind":"trial","name":"Study 2005-01","aka":["2005-01","Defitelio Study 1"],"tldr":"Study 2005-01 showed that defibrotide helped more people survive to day 100 after a stem-cell transplant when blocked liver veins had also led to kidney or lung failure, and it was the main evidence for the US approval of Defitelio.","summary":"Study 2005-01 was a multicentre, open-label, historically controlled phase 3 trial of defibrotide in adults and children with established hepatic veno-occlusive disease (sinusoidal obstruction syndrome) and advanced multi-organ failure after haematopoietic stem-cell transplant. One hundred and two patients received defibrotide at 25 mg per kilogram per day (6.25 mg per kilogram every six hours) for at least 21 days. They were compared with 32 historical controls, chosen by blinded independent reviewers from 6867 medical charts of transplant patients, and baseline characteristics were well balanced. The primary endpoint was survival at day 100 after transplant, using a propensity-adjusted analysis.\n\nDay-100 survival was 38.2 percent with defibrotide and 25 percent in the historical controls (estimated difference 23 percent, 95.1% CI 5.2 to 40.8, P = .0109). Complete response by day 100 was 25.5 percent against 12.5 percent (difference 19 percent, 95.1% CI 3.5 to 34.6, P = .0160). Bleeding and low blood pressure were the related adverse events, and common bleeding events (pulmonary alveolar 11.8 against 15.6 percent, gastrointestinal 7.8 against 9.4 percent) occurred at similar rates in the two groups (Blood 2016). The registry results add day-180 survival of 32.4 against 25.0 percent.\n\nThe US label describes the same 102 patients as Study 1, reports their day-100 survival as 38 percent (95% CI 29 to 48) and bases the approval on it. The registry counts 134 participants (102 treated plus 32 controls) and records the study as completed. The FDA approved defibrotide (Defitelio) in March 2016 for hepatic veno-occlusive disease with renal or pulmonary dysfunction after transplant. The trial treats a complication of transplant rather than a cancer, so it carries no cancer ids.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00358501","url":"https://clinicaltrials.gov/study/NCT00358501"},{"label":"Blood 2016","url":"https://doi.org/10.1182/blood-2015-10-676924"},{"label":"Defitelio label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2c3db989-d7ad-41ed-9ebf-698dcf6c24ec"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["allogeneic-hsct","autologous-stem-cell-transplant"],"targets":[],"drugs":["defibrotide"],"companies":["jazz"],"institutions":[],"pathways":[],"terms":["allogeneic-transplant"],"trials":[],"people":["paul-richardson"],"bottlenecks":[],"keyPapers":["paper-defibrotide-2005-01-blood-2016"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00358501","phase":"3","setting":"Severe hepatic veno-occlusive disease with multi-organ failure after stem-cell transplant: defibrotide in treated patients, compared with historical controls chosen by blinded review","sponsor":"Jazz Pharmaceuticals","result":"Day-100 survival 38.2% with defibrotide against 25% in historical controls (propensity-adjusted difference 23%, P = .0109); complete response by day 100 25.5% against 12.5%.","started":"2006-07","yearReported":2016,"enrolled":134,"enrolledBasis":"registry","outcomes":[{"endpoint":"Survival at day 100 after transplant","primary":true,"unit":"%","arms":[{"name":"Defibrotide","n":102,"value":38.2,"note":"Propensity-adjusted difference against historical control 23% (95.1% CI 5.2 to 40.8)"},{"name":"Historical control","n":32,"value":25}],"p":"0.0109","source":"https://doi.org/10.1182/blood-2015-10-676924"},{"endpoint":"Complete response by day 100 after transplant","unit":"%","arms":[{"name":"Defibrotide","n":102,"value":25.5,"note":"Difference against historical control 19% (95.1% CI 3.5 to 34.6), same propensity-adjusted method"},{"name":"Historical control","n":32,"value":12.5}],"p":"0.0160","source":"https://doi.org/10.1182/blood-2015-10-676924"},{"endpoint":"Survival at day 180 after transplant","unit":"%","arms":[{"name":"Defibrotide","n":102,"value":32.4},{"name":"Historical control","n":32,"value":25}],"source":"https://clinicaltrials.gov/study/NCT00358501?tab=results"}]},{"id":"study-201","kind":"trial","name":"Study 201","aka":["2005NMMF-201-US","Valchlor pivotal trial"],"tldr":"Study 201 showed that a ready-made mechlorethamine skin gel worked at least as well as a pharmacy-compounded ointment for early mycosis fungoides, and it was the main evidence for the US approval of Valchlor.","summary":"Study 201 was a randomised, multicentre, observer-blinded phase 2 pivotal trial of topical mechlorethamine in adults with stage IA to IIA mycosis fungoides-type cutaneous T-cell lymphoma who had received prior skin-directed therapy. Two hundred and sixty patients were assigned to mechlorethamine 0.02% gel or to mechlorethamine 0.02% compounded ointment, each applied once daily for up to 12 months, with tumour response and adverse events assessed monthly for six months and then every two months. The primary endpoint was the ratio of confirmed Composite Assessment of Index Lesion Severity (CAILS) response rates, with noninferiority predefined.\n\nCAILS response was 58.5 percent with the gel and 47.7 percent with the ointment (ratio 1.23, 95% CI 0.97 to 1.55), which met the prespecified noninferiority criterion. Modified Severity-Weighted Assessment Tool response was 46.9 percent against 46.2 percent. Time-to-response analyses favoured the gel (JAMA Dermatology 2013). The registry results post 76 and 62 CAILS responders out of 130 patients per arm, the same 58.5 and 47.7 percent.\n\nThe US Valchlor label describes the same 260-patient study, notes that Valchlor 0.016 percent is equivalent to 0.02 percent mechlorethamine hydrochloride, excludes 18 patients with site randomisation violations from the efficacy table (119 versus 123), and reports CAILS response 60 percent against 48 percent (ratio 1.24, 95% CI 0.98 to 1.58). The FDA approved Valchlor in 2013 for stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma after skin-directed therapy. The registry records the study as completed under org id 2005NMMF-201-US.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00168064","url":"https://clinicaltrials.gov/study/NCT00168064"},{"label":"JAMA Dermatology 2013","url":"https://doi.org/10.1001/2013.jamadermatol.541"},{"label":"Valchlor label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57"}],"tags":[],"related":[],"cancers":["cutaneous-t-cell-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["mechlorethamine"],"companies":["helsinn"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-study-201-jama-dermatol-2013"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00168064","phase":"2","setting":"Stage IA to IIA mycosis fungoides-type cutaneous T-cell lymphoma after prior skin-directed therapy: once-daily mechlorethamine 0.02% gel compared with mechlorethamine 0.02% compounded ointment for up to 12 months","sponsor":"Yaupon Therapeutics","result":"CAILS response 58.5% with mechlorethamine gel against 47.7% with compounded ointment (ratio 1.23, met noninferiority); modified SWAT response 46.9% against 46.2%.","started":"2006-05","yearReported":2013,"enrolled":260,"enrolledBasis":"registry","outcomes":[{"endpoint":"CAILS response rate","primary":true,"unit":"%","arms":[{"name":"Mechlorethamine 0.02% gel","n":130,"value":58.5,"note":"Ratio of gel to ointment response rates 1.23 (95% CI 0.97 to 1.55); noninferiority met; 130 per arm on the registry"},{"name":"Mechlorethamine 0.02% compounded ointment","n":130,"value":47.7}],"source":"https://doi.org/10.1001/2013.jamadermatol.541"},{"endpoint":"Modified SWAT response rate","unit":"%","arms":[{"name":"Mechlorethamine 0.02% gel","n":130,"value":46.9},{"name":"Mechlorethamine 0.02% compounded ointment","n":130,"value":46.2}],"source":"https://doi.org/10.1001/2013.jamadermatol.541"}]},{"id":"ts-p04834","kind":"trial","name":"Study 3 (rolapitant, moderately emetogenic chemotherapy)","aka":["Study 3","TS-P04834","TS P04834"],"tldr":"Study 3 showed that a long-lasting anti-sickness tablet, rolapitant, taken once before moderately strong chemotherapy kept more people free of vomiting and rescue medicine in the days after treatment than the usual anti-sickness pair alone; it was one of the three trials behind the US approval of Varubi.","summary":"Study 3 was a randomised, double-blind, active-controlled phase 3 trial of oral rolapitant versus placebo, each with granisetron and dexamethasone, in patients receiving moderately emetogenic chemotherapy or anthracycline plus cyclophosphamide regimens at 170 centres in 23 countries. Patients received a single 180 mg oral dose of rolapitant or matching placebo one to two hours before cycle 1. The primary endpoint was complete response, meaning no vomiting and no rescue medication, in the delayed phase from more than 24 hours to 120 hours after the start of chemotherapy.\n\nIn the Lancet Oncology 2015 report, 1,369 patients were randomly assigned (684 rolapitant, 685 active control) and 666 per arm formed the modified intention-to-treat efficacy population. Delayed-phase complete response was achieved by 475 patients (71 percent) on rolapitant versus 410 (62 percent) on active control (odds ratio 1.6, 95 percent CI 1.2 to 2.0; p = 0.0002). Adverse events were similar between arms; neutropenia was the most common grade 3 to 4 event in cycle 1 (5 percent versus 3 percent), and no serious adverse event was treatment related.\n\nThe US Varubi label names the same study Study 3 and analyses the same 666 patients per arm alongside the two cisplatin-based studies, Studies 1 and 2. ClinicalTrials.gov lists organisation id TS-P04834 as a completed phase 3 with an actual enrolment of 1,369, matching the paper. The programme treats chemotherapy-induced nausea and vomiting rather than a named cancer, so the record carries no cancer ids.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01500226","url":"https://clinicaltrials.gov/study/NCT01500226"},{"label":"Lancet Oncology 2015","url":"https://doi.org/10.1016/S1470-2045(15)00034-0"},{"label":"Varubi label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8670c3cf-82d9-466d-be49-de33d8c8742b"}],"tags":[],"related":[],"cancers":[],"sections":["supportive-care"],"technologies":[],"targets":[],"drugs":["rolapitant","granisetron","dexamethasone"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-rolapitant-study-3-schwartzberg-lancet-oncol-2015"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01500226","phase":"3","setting":"Cancer treated with moderately emetogenic chemotherapy or an anthracycline plus cyclophosphamide regimen: a single oral 180 mg dose of rolapitant versus placebo before cycle 1, both with granisetron and dexamethasone","sponsor":"Tesaro","result":"Delayed-phase complete response 71% vs 62% with active control (odds ratio 1.6, 95% CI 1.2 to 2.0; p = 0.0002).","started":"2012-02","yearReported":2015,"enrolled":1369,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response in the delayed phase (no emesis and no rescue medication, more than 24 to 120 hours), cycle 1","primary":true,"unit":"%","arms":[{"name":"Rolapitant 180 mg + granisetron + dexamethasone","n":666,"value":71,"note":"475 of 666; odds ratio 1.6 (95% CI 1.2 to 2.0) vs active control"},{"name":"Placebo + granisetron + dexamethasone (active control)","n":666,"value":62,"note":"410 of 666"}],"p":"0.0002","source":"https://doi.org/10.1016/S1470-2045(15)00034-0"}],"replication":"The two cisplatin-based pivotals, HEC-1 (NCT01499849) and HEC-2 (NCT01500213; Rapoport 2015), tested the same design in highly emetogenic chemotherapy and are not yet recorded here."},{"id":"nct06158841","kind":"trial","name":"Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refracto","aka":["CERVINO"],"tldr":"A phase 3 trial of Carfilzomib, Pomalidomide, Elotuzumab in multiple myeloma, run by AbbVie, active and no longer recruiting.","summary":"Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT06158841 by AbbVie, with 421 participants enrolled, started 2024-05-19 and due to reach its primary completion in 2027-12. Interventions recorded: Etentamig, Carfilzomib, Pomalidomide, Elotuzumab, Selinexor. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06158841","url":"https://clinicaltrials.gov/study/NCT06158841"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["carfilzomib","pomalidomide","elotuzumab","selinexor","bortezomib","dexamethasone"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06158841","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)","sponsor":"AbbVie","started":"2024-05-19","startedType":"actual","enrolled":421,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04130516","kind":"trial","name":"Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab","aka":[],"tldr":"A phase 1/2 trial of LNS8801 and Pembrolizumab in advanced solid tumours, run by Linnaeus Therapeutics, Inc., active and no longer recruiting.","summary":"Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab is a phase 1/2 interventional study registered as NCT04130516 by Linnaeus Therapeutics, Inc., with 200 participants enrolled, started 2019-10-21 and due to reach its primary completion in 2026-06-30. Interventions recorded: LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER and Pembrolizumab - anti-PD-1 antibody.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04130516","url":"https://clinicaltrials.gov/study/NCT04130516"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["lns8801","pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04130516","phase":"1/2","setting":"A Multicenter Phase 1-2A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of LNS8801 in Patients With Advanced Cancer With and Without Pembrolizumab","sponsor":"Linnaeus Therapeutics, Inc.","started":"2019-10-21","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04524000","kind":"trial","name":"Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer","aka":[],"tldr":"A phase 2 trial of Alpelisib and Fulvestrant in advanced solid tumours, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer is a phase 2 interventional study registered as NCT04524000 by Novartis Pharmaceuticals, with 24 participants enrolled, started 2021-01-08 and due to reach its primary completion in 2027-02-26. Interventions recorded: Alpelisib and Fulvestrant.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04524000","url":"https://clinicaltrials.gov/study/NCT04524000"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy","kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["alpelisib","fulvestrant"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04524000","phase":"2","setting":"A Phase II Open-label, 2-Part, Multi-center Study of BYL719 (Alpelisib) in Combination With Fulvestrant for Men and Postmenopausal Women With PIK3CA Mutation Hormone Receptor (HR) Positive, HER2-negative, Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor (AI) Treatment in Japan","sponsor":"Novartis Pharmaceuticals","started":"2021-01-08","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04544189","kind":"trial","name":"Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer","aka":[],"tldr":"A phase 2 trial of Alpelisib and Fulvestrant in advanced solid tumours, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer is a phase 2 interventional study registered as NCT04544189 by Novartis Pharmaceuticals, with 69 participants enrolled, started 2021-01-20 and due to reach its primary completion in 2027-01-29. Interventions recorded: Alpelisib, Fulvestrant and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04544189","url":"https://clinicaltrials.gov/study/NCT04544189"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy","kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["alpelisib","fulvestrant"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04544189","phase":"2","setting":"A Phase II Randomized Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Chinese Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, PIK3CA Mutant Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor (AI) Treatment, Including a Subset With Pharmacokinetic Analysis","sponsor":"Novartis Pharmaceuticals","started":"2021-01-20","startedType":"actual","enrolled":69,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04180371","kind":"trial","name":"Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression","aka":[],"tldr":"A phase 1/2 trial of Nivolumab in ovarian cancer and non-small-cell lung cancer, run by BicycleTx Limited, active and no longer recruiting.","summary":"Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression is a phase 1/2 interventional study registered as NCT04180371 by BicycleTx Limited, with 288 participants planned, started 2019-11-07 and due to reach its primary completion in 2026-07-31. Interventions recorded: BT5528, Nivolumab. Conditions listed: Advanced Solid Tumor Historically Known for High EphA2 Expression, Urothelial Cancer, Ovarian Cancer, Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04180371","url":"https://clinicaltrials.gov/study/NCT04180371"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["bicycle-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04180371","phase":"1/2","setting":"Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression","sponsor":"BicycleTx Limited","started":"2019-11-07","startedType":"actual","enrolled":288,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05163041","kind":"trial","name":"Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression","aka":[],"tldr":"A phase 1/2 trial of Nivolumab in advanced solid tumours, run by BicycleTx Limited, active and no longer recruiting.","summary":"Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression is a phase 1/2 interventional study registered as NCT05163041 by BicycleTx Limited, with 200 participants enrolled, started 2021-11-02 and due to reach its primary completion in 2026-08. Interventions recorded: BT7480 and Nivolumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05163041","url":"https://clinicaltrials.gov/study/NCT05163041"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["bicycle-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05163041","phase":"1/2","setting":"Phase 1/2 Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT7480 in Patients With Nectin-4 Associated Advanced Malignancies","sponsor":"BicycleTx Limited","started":"2021-11-02","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04561362","kind":"trial","name":"Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies","aka":[],"tldr":"A phase 1/2 trial of Zelenectide pevedotin and Pembrolizumab in bladder & urothelial cancer, triple-negative breast cancer, HR-positive / HER2-negative breast cancer, HER2-positive breast cancer, non-small-cell lung cancer and ovarian cancer, run by BicycleTx Limited, active and no longer recruiting.","summary":"Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies is a phase 1/2 interventional study registered as NCT04561362 by BicycleTx Limited, with 329 participants enrolled, started 2020-07-17 and due to reach its primary completion in 2026-03. Interventions recorded: BT8009 and Pembrolizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04561362","url":"https://clinicaltrials.gov/study/NCT04561362"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","tnbc","breast-hr-positive","breast-her2-positive","nsclc","ovarian"],"sections":[],"technologies":["peptide-drug-conjugate"],"targets":[],"drugs":["zelenectide-pevedotin","pembrolizumab"],"companies":["bicycle-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04561362-j-clin-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04561362","phase":"1/2","setting":"Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies","sponsor":"BicycleTx Limited","started":"2020-07-17","startedType":"actual","enrolled":329,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06225596","kind":"trial","name":"Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)","aka":["Duravelo-2"],"tldr":"A phase 2 trial of Zelenectide pevedotin, Pembrolizumab, Carboplatin, Cisplatin, Gemcitabine and Gemcitabine + cisplatin in bladder & urothelial cancer, run by BicycleTx Limited, active and no longer recruiting.","summary":"Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) is a phase 2 interventional study registered as NCT06225596 by BicycleTx Limited, with 375 participants enrolled, started 2024-01-24 and due to reach its primary completion in 2028-03. Interventions recorded: Zelenectide pevedotin, Pembrolizumab, Gemcitabine + cisplatin Or carboplatin and Avelumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06225596","url":"https://clinicaltrials.gov/study/NCT06225596"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["peptide-drug-conjugate"],"targets":[],"drugs":["zelenectide-pevedotin","pembrolizumab","carboplatin","cisplatin","gemcitabine","gemcitabine-cisplatin"],"companies":["bicycle-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06225596","phase":"2","setting":"A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)","sponsor":"BicycleTx Limited","started":"2024-01-24","startedType":"actual","enrolled":375,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06855277","kind":"trial","name":"Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC","aka":["AcTFirst"],"tldr":"A phase 3 trial testing AAA817 in prostate cancer, now recruiting.","summary":"Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC is a phase 3 interventional study registered as NCT06855277, led by Novartis Pharmaceuticals, and recruiting on the registry. Official title: A Phase III, Open-label, Multi-centre, Randomised Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer. Planned enrolment is 940 participants (estimated). The study started in 2025-07-01 and primary completion is expected in 2028-09-29. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06855277","url":"https://clinicaltrials.gov/study/NCT06855277"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["aaa817"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06855277","phase":"3","setting":"A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer","sponsor":"Novartis Pharmaceuticals","started":"2025-07-01","startedType":"actual","enrolled":940,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06792253","kind":"trial","name":"Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma","aka":[],"tldr":"A phase 3 trial testing Ifupinostat in diffuse large B-cell lymphoma, now recruiting.","summary":"Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma is a phase 3 interventional study registered as NCT06792253, led by BeBetter Med, and recruiting on the registry. Official title: Phase Ⅲ Clinical Trial Comparing BEBT-908 Combined With Rituximab (R) to Standard of Care for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Planned enrolment is 416 participants (estimated). The study started in 2025-01-06 and primary completion is expected in 2028-12-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06792253","url":"https://clinicaltrials.gov/study/NCT06792253"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["ifupinostat"],"companies":["bebetter-med"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06792253","phase":"3","setting":"Phase Ⅲ Clinical Trial Comparing BEBT-908 Combined With Rituximab (R) to Standard of Care for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma","sponsor":"BeBetter Med","started":"2025-01-06","startedType":"actual","enrolled":416,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04674683","kind":"trial","name":"Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma","aka":[],"tldr":"A phase 3 trial of Nivolumab in melanoma, run by HUYABIO International, LLC., active and no longer recruiting.","summary":"Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma is a phase 3 interventional study registered as NCT04674683 by HUYABIO International, LLC., with 450 participants enrolled, started 2021-08-12 and due to reach its primary completion in 2026-07. Interventions recorded: HBI-8000 in combination with nivolumab, Placebo in combination with nivolumab. Conditions listed: Unresectable or Metastatic Melanoma, Progressive Brain Metastasis. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04674683","url":"https://clinicaltrials.gov/study/NCT04674683"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["huyabio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04674683","phase":"3","setting":"A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined With Nivolumab Versus Placebo With Nivolumab in Patients With Unresectable or Metastatic Melanoma Not Previously Treated With PD-1 or PD-L1 Inhibitors","sponsor":"HUYABIO International, LLC.","started":"2021-08-12","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03061812","kind":"trial","name":"Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)","aka":["TAHOE"],"tldr":"A phase 3 trial of Rovalpituzumab tesirine, Topotecan and Dexamethasone in Small-cell lung cancer, run by AbbVie, completed.","summary":"Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE) is a phase 3 interventional study registered as NCT03061812 by AbbVie, with 444 participants recorded, started 2017-04-11 and reaching its primary completion in 2020-02-12. Interventions recorded: Rovalpituzumab tesirine, Topotecan, Dexamethasone. Conditions recorded: Small Cell Lung Cancer.\n\nLinked to the drug Rovalpituzumab tesirine because the registry names it among its interventions and Small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03061812","url":"https://clinicaltrials.gov/study/NCT03061812"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["rovalpituzumab-tesirine","topotecan","dexamethasone"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03061812","phase":"3","setting":"A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for Subjects With Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) Who Have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)","sponsor":"AbbVie","started":"2017-04-11","startedType":"actual","yearReported":2021,"enrolled":444,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Topotecan","n":148,"value":8.57,"note":"95% CI 7.69 to 10.12; Figures from the ClinicalTrials.gov results section (first posted 2021-02-23), not from a publication"},{"name":"Rovalpituzumab Tesirine","n":296,"value":6.34,"note":"95% CI 5.55 to 7.33"}],"hr":1.46,"ci":[1.17,1.82],"p":"0.0051","source":"https://clinicaltrials.gov/study/NCT03061812?tab=results"},{"endpoint":"Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Topotecan","n":148,"value":4.27,"note":"95% CI 3.75 to 5.42; Figures from the ClinicalTrials.gov results section (first posted 2021-02-23), not from a publication"},{"name":"Rovalpituzumab Tesirine","n":296,"value":3.02,"note":"95% CI 2.86 to 3.61"}],"hr":1.51,"ci":[1.22,1.87],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT03061812?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"Topotecan","n":129,"value":20.9,"note":"95% CI 14.27 to 28.97; Figures from the ClinicalTrials.gov results section (first posted 2021-02-23), not from a publication"},{"name":"Rovalpituzumab Tesirine","n":287,"value":14.6,"note":"95% CI 10.75 to 19.26"}],"p":"0.3352","source":"https://clinicaltrials.gov/study/NCT03061812?tab=results"}]},{"id":"nct05917405","kind":"trial","name":"Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT","aka":["FLUCLORIC"],"tldr":"A phase 2 trial of Fludarabine, Busulfan and Clofarabine in Acute myeloid leukaemia, run by Nantes University Hospital, now recruiting.","summary":"Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT is a phase 2 interventional study registered as NCT05917405 by Nantes University Hospital, with 302 participants planned, started 2023-09-14 and due to reach its primary completion in 2028-09-14. Interventions recorded: Fludarabine, Busulfan, ATG, Clofarabine. Conditions recorded: Acute Myeloid Leukemia in Remission.\n\nLinked to the drug Clofarabine because the registry names it among its interventions and Acute myeloid leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05917405","url":"https://clinicaltrials.gov/study/NCT05917405"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":["fludarabine","busulfan","clofarabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05917405","phase":"2","setting":"FLUCLORIC: Randomized Multicentric Phase III Study Comparing the Efficacy of 2 Reduced Intensity Conditioning Regimens (Clofarabine/Busulfan vs Fludarabine/Busulfan) in Adults With AML and Eligible to Allogeneic Stem Cell Transplantation","sponsor":"Nantes University Hospital","started":"2023-09-14","startedType":"actual","enrolled":302,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05078047","kind":"trial","name":"Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO","aka":["MOIO"],"tldr":"A phase 3 trial in triple-negative breast cancer, run by UNICANCER, active but no longer recruiting.","summary":"Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO is a phase 3, randomised interventional study registered as NCT05078047 by UNICANCER, with a registry enrolment figure of 646 participants, started 2022-03-08 and due to reach its primary completion in 2029-05-07. Interventions recorded: Reduced dose intensity of IO. Conditions listed: Lung Cancer Metastatic; Renal Cell Carcinoma; Head and Neck Cancer; Triple Negative Breast Cancer; Merkel Cell Carcinoma; Hepatocellular Carcinoma; Melanoma; Urothelial Carcinoma; Colorectal Carcinoma With Microsatellite Instability; Esophageal Squamous Cell Carcinoma; Endometrial Carcinoma; Cervical Cancer; Gastric/Gastro-esophageal Junction/Esophageal Adenocarcinoma; Basal Cell Carcinoma; Squamous Skin Carcinoma. Triple-negative eligibility wording from the registry: \"Metastatic disease (or locally advanced disease not suitable for local treatment) of initial tumor histologically confirmed including: lung cancer, renal cell cancer, head and neck cancer, urothelial carcinoma, triple negative breast cancer, Merkel cancer, hepatocellular carcinoma, melanoma, colorec\". Sites: France. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05078047","url":"https://clinicaltrials.gov/study/NCT05078047"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05078047","phase":"3","setting":"Randomized Phase III Trial of Standard Immunotherapy (IO) by Checkpoint Inhibitors, Versus Reduced Dose Intensity of IO in Patients With Locally Advanced or Metastatic Cancer in Response After 6 Months of Standard IO","sponsor":"UNICANCER","started":"2022-03-08","startedType":"actual","enrolled":646,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04632758","kind":"trial","name":"Study Comparing WX-0593 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients","aka":[],"tldr":"A phase 3 trial of Iruplinalkib and Crizotinib in Non-small-cell lung cancer, run by Qilu Pharmaceutical Co., Ltd., with a status the registry has not verified recently.","summary":"Study Comparing WX-0593 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients is a phase 3 interventional study registered as NCT04632758 by Qilu Pharmaceutical Co., Ltd., with 292 participants planned, started 2019-06-01 and due to reach its primary completion in 2024-12-01. Interventions recorded: WX-0593 Tablets, crizotinib. Conditions recorded: Non-small Cell Lung Cancer.\n\nLinked to the drug Iruplinalkib because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04632758","url":"https://clinicaltrials.gov/study/NCT04632758"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","alk-positive-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["iruplinalkib","crizotinib"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04632758","phase":"3","setting":"An Open-label, Randomized, Multicenter Phase 3 Study Comparing WX-0593 to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2019-06-01","startedType":"actual","enrolled":292,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07189455","kind":"trial","name":"Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial testing ZG006 in non-small-cell lung cancer, now recruiting.","summary":"Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer is a phase 3 interventional study registered as NCT07189455, led by Suzhou Zelgen Biopharmaceuticals, and recruiting on the registry. Official title: A Multicenter, Randomised, Controlled, Open-Label Phase III Study Evaluating the Efficacy and Safety of ZG006 for Injection Compared With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer. Planned enrolment is 420 participants (estimated). The study started in 2025-12-12 and primary completion is expected in 2028-10. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07189455","url":"https://clinicaltrials.gov/study/NCT07189455"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["zg006"],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07189455","phase":"3","setting":"A Multicenter, Randomized, Controlled, Open-Label Phase III Study Evaluating the Efficacy and Safety of ZG006 for Injection Compared With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer","sponsor":"Suzhou Zelgen Biopharmaceuticals","started":"2025-12-12","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04050436","kind":"trial","name":"Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer","aka":["CERPASS"],"tldr":"A phase 2 trial of Cemiplimab in cutaneous squamous cell carcinoma, run by Replimune, Inc., active and no longer recruiting.","summary":"Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer is a phase 2 interventional study registered as NCT04050436 by Replimune, Inc., with 231 participants enrolled, started 2019-10-08 and due to reach its primary completion in 2025-09. Interventions recorded: Cemiplimab, RP1. Conditions listed: Cutaneous Squamous Cell Carcinoma, Advanced Cutaneous Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04050436","url":"https://clinicaltrials.gov/study/NCT04050436"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cutaneous-scc","advanced-cutaneous-scc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["replimune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04050436","phase":"2","setting":"A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma","sponsor":"Replimune, Inc.","started":"2019-10-08","startedType":"actual","enrolled":231,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06549465","kind":"trial","name":"Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer (CRPC)","aka":[],"tldr":"A phase 2 trial of In-111 rosopatamab tetraxetan in prostate cancer, run by Convergent Therapeutics, now recruiting.","summary":"Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer (CRPC) is a phase 2 interventional study registered as NCT06549465 by Convergent Therapeutics, with 93 participants planned, started 2024-08-06 and due to reach its primary completion in 2027-04-20. Interventions recorded: In-111 rosopatamab tetraxetan, 45 kBq/kg Ac-225 rosopatamab tetraxetan, 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan, 60 kBq/kg Ac-225 rosopatamab tetraxetan, Single dose 22 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan and Single dose 34 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06549465","url":"https://clinicaltrials.gov/study/NCT06549465"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["convergent-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06549465","phase":"2","setting":"A Phase 2, Open-label Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer","sponsor":"Convergent Therapeutics","started":"2024-08-06","startedType":"actual","enrolled":93,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04736173","kind":"trial","name":"Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer","aka":[],"tldr":"A phase 2 trial of Domvanalimab, Zimberelimab, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Arcus Biosciences, Inc., active and no longer recruiting.","summary":"Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer is a phase 2 interventional study registered as NCT04736173 by Arcus Biosciences, Inc., with 169 participants enrolled, started 2021-02-08 and due to reach its primary completion in 2027-05. Interventions recorded: Domvanalimab, Zimberelimab, Carboplatin, Paclitaxel, Pemetrexed. Conditions listed: Non Small Cell Lung Cancer, Nonsquamous Non Small Cell Lung Cancer, Squamous Non Small Cell Lung Cancer, Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04736173","url":"https://clinicaltrials.gov/study/NCT04736173"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["domvanalimab","zimberelimab","carboplatin","paclitaxel","pemetrexed","pembrolizumab"],"companies":["arcus-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04736173","phase":"2","setting":"Official Title: A Phase 2 Study to Evaluate Zimberelimab (AB122) Combined With AB154 in Front-Line, PD-L1-High, Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Arcus Biosciences, Inc.","started":"2021-02-08","startedType":"actual","enrolled":169,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06117774","kind":"trial","name":"Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)","aka":["DeLLphi-306"],"tldr":"A phase 3 trial of Tarlatamab in small-cell lung cancer, run by Amgen, active and no longer recruiting.","summary":"Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) is a phase 3 interventional study registered as NCT06117774 by Amgen, with 404 participants enrolled, started 2024-02-20 and due to reach its primary completion in 2030-04-20. Interventions recorded: Tarlatamab, Placebo. Conditions listed: Limited Stage Small Cell Lung Cancer, Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06117774","url":"https://clinicaltrials.gov/study/NCT06117774"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","limited-stage-sclc"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["tarlatamab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06117774","phase":"3","setting":"A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Who Have Not Progressed Following Concurrent Chemoradiation Therapy","sponsor":"Amgen","started":"2024-02-20","startedType":"actual","enrolled":404,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06502977","kind":"trial","name":"Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment","aka":["DeLLphi-307"],"tldr":"A phase 2 trial of Tarlatamab in small-cell lung cancer, run by Amgen, active and no longer recruiting.","summary":"Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment is a phase 2 interventional study registered as NCT06502977 by Amgen, with 32 participants enrolled, started 2024-08-27 and due to reach its primary completion in 2025-03-28. Interventions recorded: Tarlatamab. Conditions listed: Extensive Stage Small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06502977","url":"https://clinicaltrials.gov/study/NCT06502977"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["tarlatamab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06502977","phase":"2","setting":"Phase 2a Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of Tarlatamab in Chinese Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-307)","sponsor":"Amgen","started":"2024-08-27","startedType":"actual","yearReported":2026,"enrolled":32,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)","primary":true,"unit":"%","arms":[{"name":"Tarlatamab","n":31,"value":38.7,"note":"95% CI 21.8 to 57.8; Figures from the ClinicalTrials.gov results section (first posted 2026-04-15), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT06502977?tab=results"}]},{"id":"nct04749108","kind":"trial","name":"Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma","aka":["GRECCAR14"],"tldr":"A phase 2/3 trial in colorectal cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle, now recruiting.","summary":"Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma is a phase 2/3, randomised interventional study registered as NCT04749108 by Institut du Cancer de Montpellier - Val d'Aurelle, with a registry enrolment figure of 1075 participants, started 2021-11-26 and due to reach its primary completion in 2029-09. Interventions recorded: Induction chemotherapy - modified FOLFIRINOX regimen; Early tumor response evaluation by MRI volumetry; Radiochemotherapy Cap 50; Radical proctectomy with total mesorectal excision. Conditions listed: Locally Advanced Malignant Neoplasm; Rectal Carcinoma. Primary outcome: R0 resection rate (R0 is defined as Circumferential resection margin (CRM ≥ 1 mm) for Phase II; 3-year Disease free survival (DFS) for Phase III. Colorectal eligibility wording from the registry: \"Histologically confirmed diagnosis of adenocarcinoma of the rectum,\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04749108","url":"https://clinicaltrials.gov/study/NCT04749108"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04749108","phase":"2/3","setting":"Multicentric Phase II-III Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma After a Favorable Response to Induction Chemotherapy","sponsor":"Institut du Cancer de Montpellier - Val d'Aurelle","started":"2021-11-26","startedType":"actual","enrolled":1075,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07118800","kind":"trial","name":"Study Evaluating Two Treatment Strategies for Rectal Cancer in Patients ≥75 Years Old","aka":["NACRE-2"],"tldr":"A phase 3 trial in colorectal cancer, run by UNICANCER, not yet recruiting.","summary":"Study Evaluating Two Treatment Strategies for Rectal Cancer in Patients ≥75 Years Old is a phase 3, randomised interventional study registered as NCT07118800 by UNICANCER, with a registry enrolment figure of 160 participants, started 2026-07-24 and due to reach its primary completion in 2030-12-15. Interventions recorded: FOLFOX4s; Short Course Radiotherapy. Conditions listed: Locally Advanced Rectal Adenocarcinoma. Primary outcome: TME-free survival. Colorectal eligibility wording from the registry: \"Histologically confirmed diagnosis of adenocarcinoma of the rectum\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07118800","url":"https://clinicaltrials.gov/study/NCT07118800"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07118800","phase":"3","setting":"Randomized Phase III Study Evaluating Two Treatment Strategies for Locally Advanced Rectal Cancer in Patients ≥75 Years Old","sponsor":"UNICANCER","started":"2026-07-24","startedType":"estimated","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05607420","kind":"trial","name":"Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma","aka":["NatHaLi-01"],"tldr":"A phase 1/2 trial of Alemtuzumab in hodgkin lymphoma and non-hodgkin lymphoma, run by Cellectis S.A., now recruiting.","summary":"Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma is a phase 1/2 interventional study registered as NCT05607420 by Cellectis S.A., with 80 participants planned, started 2022-11-01 and due to reach its primary completion in 2027-08. Interventions recorded: UCART20x22, CLLS52. Conditions listed: B-cell Non-Hodgkin Lymphoma (B-NHL). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05607420","url":"https://clinicaltrials.gov/study/NCT05607420"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["alemtuzumab"],"companies":["cellectis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05607420","phase":"1/2","setting":"Open-label Dose-finding and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART20x22 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (B-NHL)","sponsor":"Cellectis S.A.","started":"2022-11-01","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06921928","kind":"trial","name":"Study for AZD4360 in Participants With Advanced Solid Tumours","aka":[],"tldr":"A phase 1/2 trial of AZD4360 in pancreatic ductal adenocarcinoma, run by AstraZeneca, active and no longer recruiting.","summary":"Study for AZD4360 in Participants With Advanced Solid Tumours is a phase 1/2 interventional study registered as NCT06921928 by AstraZeneca, with 31 participants enrolled, started 2025-04-29 and due to reach its primary completion in 2027-03-31. Interventions recorded: AZD4360. Conditions listed: Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06921928","url":"https://clinicaltrials.gov/study/NCT06921928"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["azd4360"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06921928","phase":"1/2","setting":"A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD4360 in Adult Participants With Advanced Solid Tumours","sponsor":"AstraZeneca","started":"2025-04-29","startedType":"actual","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05226871","kind":"trial","name":"Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies","aka":[],"tldr":"A phase 2 trial of Palbociclib, Cetuximab and Fulvestrant in head and neck squamous cell carcinoma, run by Pfizer, active and no longer recruiting.","summary":"Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies is a phase 2 interventional study registered as NCT05226871 by Pfizer, with 35 participants enrolled, started 2022-07-07 and due to reach its primary completion in 2029-12-31. Interventions recorded: Palbociclib, Cetuximab, Fulvestrant and Letrozole.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05226871","url":"https://clinicaltrials.gov/study/NCT05226871"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["palbociclib","cetuximab","fulvestrant"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05226871","phase":"2","setting":"A TREATMENT PROTOCOL FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED PALBOCICLIB CLINICAL STUDIES","sponsor":"Pfizer","started":"2022-07-07","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03603795","kind":"trial","name":"Study Impact on Outcome of Eltrombopag in Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy","aka":[],"tldr":"A phase 2 trial of Eltrombopag in Acute myeloid leukaemia, run by French Innovative Leukemia Organisation, active and no longer recruiting.","summary":"Study Impact on Outcome of Eltrombopag in Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy is a phase 2 interventional study registered as NCT03603795 by French Innovative Leukemia Organisation, with 110 participants planned, started 2018-10-11 and due to reach its primary completion in 2022-06-15. Interventions recorded: Eltrombopag, Placebo. Conditions recorded: Acute Myeloid Leukemia.\n\nLinked to the drug Eltrombopag because the registry names it among its interventions and Acute myeloid leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03603795","url":"https://clinicaltrials.gov/study/NCT03603795"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-older-unfit"],"sections":[],"technologies":[],"targets":[],"drugs":["eltrombopag"],"companies":["filo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03603795","phase":"2","setting":"A Phase II Randomized Placebo-controlled Study to Assess the Impact on Outcome of Eltrombopag Administered to Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy","sponsor":"French Innovative Leukemia Organisation","started":"2018-10-11","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07300943","kind":"trial","name":"Study in Advanced Solid Tumor Patients","aka":[],"tldr":"A phase 1/2 trial of CLIO-8221 in advanced solid tumours, run by Callio Therapeutics, now recruiting.","summary":"Study in Advanced Solid Tumor Patients is a phase 1/2 interventional study registered as NCT07300943 by Callio Therapeutics, with 306 participants planned, started 2026-03-19 and due to reach its primary completion in 2027-12-31. Interventions recorded: CLIO-8221.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07300943","url":"https://clinicaltrials.gov/study/NCT07300943"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["callio-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07300943","phase":"1/2","setting":"A Phase 1/2 Study of CLIO-8221 in Patients With Advanced Solid Tumors","sponsor":"Callio Therapeutics","started":"2026-03-19","startedType":"actual","enrolled":306,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04776655","kind":"trial","name":"Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB","aka":["LIBImAb"],"tldr":"A phase 3 trial of bevacizumab (glioblastoma use), cetuximab, fluorouracil (5-FU) and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by Azienda USL Reggio Emilia - IRCCS, active but no longer recruiting.","summary":"Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB is a phase 3, randomised interventional study registered as NCT04776655 by Azienda USL Reggio Emilia - IRCCS, with a registry enrolment figure of 280 participants, started 2021-04-30 and due to reach its primary completion in 2025-05-04. Interventions recorded: Bevacizumab; Cetuximab; 5-FU; Irinotecan; Calcium levofolinate. Conditions listed: Colorectal Cancer; Metastatic Colorectal Cancer; RAS Mutation. Primary outcome: Progression free survival (PFS) in patients with RASmut at liquid biopsy and RASwt on tissue.. Colorectal eligibility wording from the registry: \"Histologically confirmed diagnosis of colorectal adenocarcinoma RAS/BRAF wild type (analysed either on primary and/or related metastasis);\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04776655","url":"https://clinicaltrials.gov/study/NCT04776655"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["bevacizumab-glioma","cetuximab","fluorouracil","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04776655","phase":"3","setting":"Phase III Study in mCRC Patients With RAS/BRAF Wild Type Tissue and RAS Mutated in LIquid BIopsy to Compare in First-line Therapy FOLFIRI Plus CetuxiMAb or BevacizumaB (LIBImAb Study)","sponsor":"Azienda USL Reggio Emilia - IRCCS","started":"2021-04-30","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07483983","kind":"trial","name":"Study Investigating ASP3082 in Patients With Metastatic/Locally Advanced Non-small-cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Bi","aka":["UNLOCK ASP3082"],"tldr":"A phase 2 trial of setidegrasib in pancreatic cancer, run by Gustave Roussy, Cancer Campus, Grand Paris, now recruiting.","summary":"Study Investigating ASP3082 in Patients With Metastatic/Locally Advanced Non-small-cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Biomarker Analysis to Characterize Response/Resistance is a phase 2, interventional study registered as NCT07483983 by Gustave Roussy, Cancer Campus, Grand Paris, with a registry enrolment figure of 60 participants, started 2026-03-25 and due to reach its primary completion in 2027-09. Interventions recorded: ASP3082. Conditions listed: Metastatic/Locally Advanced Non-Small-Cell Lung Cancer; Metastatic/Locally Pancreatic Ductal Adenocarcinoma. Primary outcome: Evaluate the best overall response (BOR) based on investigator assessment per RECIST v1.1. Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07483983","url":"https://clinicaltrials.gov/study/NCT07483983"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["setidegrasib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07483983","phase":"2","setting":"Phase 2, Multicenter, Open Label, Platform Study Investigating ASP3082 in Patients With Metastaic/Locally Non-Small-Cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Biomarker Analysis to Characterize Response/Resistance","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","started":"2026-03-25","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07016230","kind":"trial","name":"Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differentiated Neuroendocri","aka":[],"tldr":"A phase 2 trial of tarlatamab in lung cancer, run by Gustave Roussy, Cancer Campus, Grand Paris, now recruiting.","summary":"Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differentiated Neuroendocrine Carcinomas (NECs), With Biomarker Analysis to Characterize Response/Resistance (UNLOCK TARLATAMAB) is a phase 2, interventional study registered as NCT07016230 by Gustave Roussy, Cancer Campus, Grand Paris, with a registry enrolment figure of 40 participants, started 2025-07-02 and due to reach its primary completion in 2027-05-18. Interventions recorded: Tarlatamab. Conditions listed: Metastatic/Locally Advanced Small-Cell Lung Cancer; Metastatic/Locally Advanced Poorly Differentiated NEC. Primary outcome: To estimate the objective response rate (ORR). Lung eligibility wording from the registry: \"Patients with histologically confirmed diagnosis of metastatic/locally advanced SCLC with any level of DLL3 expression (Cohort 1) or other poorly differentiated NECs whatever the primary based on the most recent biopsy of a metastatic site\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07016230","url":"https://clinicaltrials.gov/study/NCT07016230"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["bispecific-antibody","t-cell-engager"],"targets":[],"drugs":["tarlatamab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07016230","phase":"2","setting":"Phase 2, Multicenter, Open Label, Platform Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differentiated Neuroendocrine Carcinomas (NECs), With Biomarker Analysis to Characterize Response/Resistance","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","started":"2025-07-02","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07278479","kind":"trial","name":"Study of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of [212Pb]Pb-MP0712 in neuroendocrine tumours, small-cell lung cancer, pancreatic ductal adenocarcinoma and bladder & urothelial cancer, run by Molecular Partners AG, now recruiting.","summary":"Study of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors is a phase 1/2 interventional study registered as NCT07278479 by Molecular Partners AG, with 138 participants planned, started 2026-05-18 and due to reach its primary completion in 2028-09. Interventions recorded: [212Pb]Pb-MP0712.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07278479","url":"https://clinicaltrials.gov/study/NCT07278479"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine","sclc","pancreatic","urothelial"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["molecular-partners","orano-med"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07278479","phase":"1/2","setting":"A Phase 1/2a Study to Assess Safety, Tolerability, and Efficacy of [212Pb]Pb-DOTAM-MAM279 in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors","sponsor":"Molecular Partners AG","started":"2026-05-18","startedType":"actual","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02981368","kind":"trial","name":"Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer","aka":["OSPREY"],"tldr":"A phase 2/3 trial of Piflufolastat F-18 / Pylarify TruVu in Prostate cancer, run by Progenics Pharmaceuticals, Inc., completed.","summary":"Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer is a phase 2/3 interventional study registered as NCT02981368 by Progenics Pharmaceuticals, Inc., with 385 participants recorded, started 2016-11 and reaching its primary completion in 2018-07. Interventions recorded: 18F-DCFPyL Injection, PET/CT imaging. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Piflufolastat F-18 / Pylarify TruVu because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02981368","url":"https://clinicaltrials.gov/study/NCT02981368"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["pylarify"],"companies":["lantheus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02981368","phase":"2/3","setting":"A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY)","sponsor":"Progenics Pharmaceuticals, Inc.","started":"2016-11","startedType":"actual","enrolled":385,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03739684","kind":"trial","name":"Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Piflufolastat F-18 / Pylarify TruVu in Prostate cancer, run by Progenics Pharmaceuticals, Inc., completed.","summary":"Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer is a phase 3 interventional study registered as NCT03739684 by Progenics Pharmaceuticals, Inc., with 208 participants recorded, started 2018-11-27 and reaching its primary completion in 2019-08-29. Interventions recorded: 18F-DCFPyL, PET/CT Imaging. Conditions recorded: Prostate Cancer, Prostate Adenocarcinoma, Prostate Cancer Recurrent, Prostate Cancer Metastatic.\n\nLinked to the drug Piflufolastat F-18 / Pylarify TruVu because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03739684","url":"https://clinicaltrials.gov/study/NCT03739684"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["pylarify"],"companies":["lantheus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03739684","phase":"3","setting":"A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Clinical Impact of 18F-DCFPyL PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer","sponsor":"Progenics Pharmaceuticals, Inc.","started":"2018-11-27","startedType":"actual","enrolled":208,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06754085","kind":"trial","name":"Study of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Florastamin[18F] Injection in prostate cancer, run by HTA Co., Ltd., now recruiting.","summary":"Study of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer is a phase 3 interventional study registered as NCT06754085 by HTA Co., Ltd., with 131 participants planned, started 2024-12-19 and due to reach its primary completion in 2026-01-01. Interventions recorded: Florastamin[18F] Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06754085","url":"https://clinicaltrials.gov/study/NCT06754085"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["pet","pet-ct"],"targets":[],"drugs":["florastamin-f18"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06754085","phase":"3","setting":"A Phase III, Prospective, Open-Label, Single-Arm, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer","sponsor":"HTA Co., Ltd.","started":"2024-12-19","startedType":"actual","enrolled":131,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00045968","kind":"trial","name":"Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer","aka":[],"tldr":"A phase 3 trial of DCVax-L in Glioma & glioblastoma and Brain and spinal cord tumours, run by Northwest Biotherapeutics, with a status the registry has not verified recently.","summary":"Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer is a phase 3 interventional study registered as NCT00045968 by Northwest Biotherapeutics, with 348 participants planned, started 2006-12 and due to reach its primary completion in 2022-11. Interventions recorded: Dendritic cell immunotherapy. Conditions recorded: Glioblastoma Multiforme, Glioblastoma, GBM, Grade IV Astrocytoma, Glioma, Brain Cancer, Brain Tumor.\n\nLinked to the drug DCVax-L because the registry names it among its interventions and Glioma & glioblastoma and Brain and spinal cord tumours among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00045968","url":"https://clinicaltrials.gov/study/NCT00045968"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma","brain-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["dcvax-l"],"companies":["northwest-biotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00045968","phase":"3","setting":"A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM)","sponsor":"Northwest Biotherapeutics","started":"2006-12","enrolled":348,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00100243","kind":"trial","name":"Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy","aka":[],"tldr":"A phase 2 trial of Abarelix in Prostate cancer, run by PRAECIS Pharmaceuticals Inc., completed.","summary":"Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy is a phase 2 interventional study registered as NCT00100243 by PRAECIS Pharmaceuticals Inc., with 22 participants recorded, started 2004-05. Interventions recorded: Plenaxis. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Abarelix because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00100243","url":"https://clinicaltrials.gov/study/NCT00100243"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["abarelix"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00100243","phase":"2","setting":"Phase 2 Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy","sponsor":"PRAECIS Pharmaceuticals Inc.","started":"2004-05","enrolled":22,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05386108","kind":"trial","name":"Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer","aka":["ELECTRA"],"tldr":"A phase 1/2 trial of Elacestrant and Abemaciclib in brain and spinal cord tumours, run by Stemline Therapeutics, Inc., now recruiting.","summary":"Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer is a phase 1/2 interventional study registered as NCT05386108 by Stemline Therapeutics, Inc., with 73 participants planned, started 2022-08-31 and due to reach its primary completion in 2026-12. Interventions recorded: Elacestrant and Abemaciclib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05386108","url":"https://clinicaltrials.gov/study/NCT05386108"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["brain-tumours","secondary-brain-tumours"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy"],"targets":[],"drugs":["elacestrant","abemaciclib"],"companies":["menarini"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05386108","phase":"1/2","setting":"An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer","sponsor":"Stemline Therapeutics, Inc.","started":"2022-08-31","startedType":"actual","enrolled":73,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03600441","kind":"trial","name":"Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma","aka":["FORERUNNER"],"tldr":"A phase 2 trial of Abexinostat in follicular lymphoma, run by Xynomic Pharmaceuticals, Inc., active and no longer recruiting.","summary":"Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma is a phase 2 interventional study registered as NCT03600441 by Xynomic Pharmaceuticals, Inc., with 139 participants planned, started 2018-08-27 and due to reach its primary completion in 2027-12-31. Interventions recorded: Abexinostat. Conditions listed: Follicular Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03600441","url":"https://clinicaltrials.gov/study/NCT03600441"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["abexinostat"],"companies":["xynomic-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03600441","phase":"2","setting":"Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER)","sponsor":"Xynomic Pharmaceuticals, Inc.","started":"2018-08-27","startedType":"actual","enrolled":139,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02477696","kind":"trial","name":"Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)","aka":[],"tldr":"A phase 3 trial of Acalabrutinib and Ibrutinib in chronic lymphocytic leukaemia, run by Acerta Pharma BV, active and no longer recruiting.","summary":"Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL) is a phase 3 interventional study registered as NCT02477696 by Acerta Pharma BV, with 533 participants enrolled, started 2015-07-28 and due to reach its primary completion in 2020-09-15. Interventions recorded: Acalabrutinib and Ibrutinib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02477696","url":"https://clinicaltrials.gov/study/NCT02477696"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["acalabrutinib","ibrutinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02477696","phase":"3","setting":"A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia","sponsor":"Acerta Pharma BV","started":"2015-07-28","startedType":"actual","yearReported":2022,"enrolled":533,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment","primary":true,"unit":"months","arms":[{"name":"Acalabrutinib","n":268,"value":38.4,"note":"95% CI 33.0 to 38.6; Figures from the ClinicalTrials.gov results section (first posted 2022-01-28), not from a publication"},{"name":"Ibrutinib","n":265,"value":38.4,"note":"95% CI 33.0 to 41.6"}],"hr":1,"ci":[0.79,1.27],"source":"https://clinicaltrials.gov/study/NCT02477696?tab=results"}]},{"id":"nct02180711","kind":"trial","name":"Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma","aka":[],"tldr":"A phase 1/2 trial of Acalabrutinib, Rituximab, Lenalidomide in hodgkin lymphoma and non-hodgkin lymphoma, run by Acerta Pharma BV, active and no longer recruiting.","summary":"Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma is a phase 1/2 interventional study registered as NCT02180711 by Acerta Pharma BV, with 113 participants enrolled, started 2014-12-29 and due to reach its primary completion in 2023-08-25. Interventions recorded: acalabrutinib, rituximab (IV), Lenalidomide. Conditions listed: Non Hodgkin Lymphoma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02180711","url":"https://clinicaltrials.gov/study/NCT02180711"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["acalabrutinib","rituximab","lenalidomide"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02180711","phase":"1/2","setting":"An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma","sponsor":"Acerta Pharma BV","started":"2014-12-29","startedType":"actual","yearReported":2025,"enrolled":113,"enrolledBasis":"registry","outcomes":[{"endpoint":"Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL).","primary":true,"unit":"%","arms":[{"name":"Part 2: Acalabrutinib","n":43,"value":60.5,"note":"95% CI 44.4 to 75.0; Figures from the ClinicalTrials.gov results section (first posted 2025-10-15), not from a publication"},{"name":"Part 2: Acalabrutinib + Rituximab","n":1,"value":0,"note":"95% CI 0 to 97.5"}],"source":"https://clinicaltrials.gov/study/NCT02180711?tab=results"}]},{"id":"nct05952024","kind":"trial","name":"Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL","aka":["ACRUE"],"tldr":"A phase 2 trial of Acalabrutinib, Rituximab in diffuse large b-cell lymphoma, run by AstraZeneca, now recruiting.","summary":"Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL is a phase 2 interventional study registered as NCT05952024 by AstraZeneca, with 80 participants planned, started 2024-07-16 and due to reach its primary completion in 2029-04-22. Interventions recorded: Acalabrutinib, Rituximab. Conditions listed: Diffuse Large B-Cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05952024","url":"https://clinicaltrials.gov/study/NCT05952024"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["acalabrutinib","rituximab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05952024","phase":"2","setting":"A Prospective, Open-Label, Single-Arm, Phase II Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With Diffuse Large B-Cell Lymphoma (ACRUE)","sponsor":"AstraZeneca","started":"2024-07-16","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03932331","kind":"trial","name":"Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malign","aka":[],"tldr":"A phase 1/2 trial of Acalabrutinib in mantle cell lymphoma, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies is a phase 1/2 interventional study registered as NCT03932331 by AstraZeneca, with 105 participants enrolled, started 2020-04-29 and due to reach its primary completion in 2022-12-22. Interventions recorded: Acalabrutinib. Conditions listed: Phase I: Relapsed or Refractory B-cell Malignancies, Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma, Phase II Cohort B: Relapsed or Refractory Chronic Lymphocytic Leukemia. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03932331","url":"https://clinicaltrials.gov/study/NCT03932331"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["acalabrutinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03932331","phase":"1/2","setting":"A Phase 1/2 Open Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies","sponsor":"AstraZeneca","started":"2020-04-29","startedType":"actual","yearReported":2025,"enrolled":105,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase II: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR)","primary":true,"unit":"%","arms":[{"name":"Phase II MCL","n":34,"value":82.4,"note":"95% CI 65.5 to 93.2; Figures from the ClinicalTrials.gov results section (first posted 2025-03-20), not from a publication"},{"name":"Phase II CLL","n":60,"value":86.7,"note":"95% CI 75.4 to 94.1"}],"source":"https://clinicaltrials.gov/study/NCT03932331?tab=results"},{"endpoint":"Phase II: Percentage of Participants With Overall Survival (OS) at Month 6","unit":"%","arms":[{"name":"Phase II MCL","n":34,"note":"The OS is not mature to report median and 95% confidence interval at time of analysis.; Figures from the ClinicalTrials.gov results section (first posted 2025-03-20), not from a publication"},{"name":"Phase II CLL","n":60,"value":96.7,"note":"95% CI 87.3 to 99.2"}],"source":"https://clinicaltrials.gov/study/NCT03932331?tab=results"}]},{"id":"nct04075292","kind":"trial","name":"Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia","aka":[],"tldr":"A phase 3 trial of Acalabrutinib, Rituximab and Chlorambucil in chronic lymphocytic leukaemia, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia is a phase 3 interventional study registered as NCT04075292 by AstraZeneca, with 155 participants enrolled, started 2020-01-20 and due to reach its primary completion in 2024-01-03. Interventions recorded: Acalabrutinib, Rituximab and Chlorambucil. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04075292","url":"https://clinicaltrials.gov/study/NCT04075292"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["acalabrutinib","rituximab","chlorambucil"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04075292","phase":"3","setting":"A Randomized, Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Acalabrutinib Versus Chlorambucil Plus Rituximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia","sponsor":"AstraZeneca","started":"2020-01-20","startedType":"actual","yearReported":2025,"enrolled":155,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) Assessed by BICR","primary":true,"unit":"months","arms":[{"name":"Acalabrutinib","n":77,"note":"NA indicated that the median, lower and upper limit of 95% CI were not estimable due to insufficient number of participants with events.; Figures from the ClinicalTrials.gov results section (first posted 2025-01-30), not from a publication"},{"name":"Chlorambucil Plus Rituximab","n":78,"value":15.54,"note":"95% CI 11.53 to 17.54"}],"hr":0.08,"ci":[0.03,0.18],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT04075292?tab=results"}]},{"id":"nct06380660","kind":"trial","name":"Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ACE-86225106 tablet in ovarian cancer and prostate cancer, run by Acerand Therapeutics (Shanghai) Limited, active and no longer recruiting.","summary":"Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06380660 by Acerand Therapeutics (Shanghai) Limited, with 298 participants enrolled, started 2024-03-22 and due to reach its primary completion in 2028-12-21. Interventions recorded: ACE-86225106 tablet.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06380660","url":"https://clinicaltrials.gov/study/NCT06380660"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06380660","phase":"1/2","setting":"A Phase I/II, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of ACE-86225106 as Monotherapy in Patients With Advanced Solid Tumors","sponsor":"Acerand Therapeutics (Shanghai) Limited","started":"2024-03-22","startedType":"actual","enrolled":298,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03562637","kind":"trial","name":"Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC","aka":["GLORIA"],"tldr":"A phase 3 trial of Adagloxad simolenin run by OBI Pharma, Inc, active.","summary":"Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC is a phase 3 interventional study registered as NCT03562637 by OBI Pharma, Inc, with 575 participants enrolled, started 2018-12-05. Conditions listed: Triple Negative Breast Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03562637","url":"https://clinicaltrials.gov/study/NCT03562637"}],"tags":["ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["dendritic-cell-vaccines"],"targets":[],"drugs":["adagloxad-simolenin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03562637","phase":"3","setting":"The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With High Risk, Early Stage Globo H-Positive Triple Negative Breast Cancer","sponsor":"OBI Pharma, Inc","started":"2018-12-05","startedType":"actual","enrolled":575,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06599775","kind":"trial","name":"Study of Adebrelimab With Chemotherapy, Endoscopy and Sequential Chemoradiotherapy In Inoperable Esophageal Cancer","aka":[],"tldr":"A phase 2 trial of Endoscopic resection in Oesophageal squamous cell carcinoma, run by Shanghai Zhongshan Hospital, not yet recruiting.","summary":"Study of Adebrelimab With Chemotherapy, Endoscopy and Sequential Chemoradiotherapy In Inoperable Esophageal Cancer is a phase 2 interventional study registered as NCT06599775 by Shanghai Zhongshan Hospital, with 42 participants planned, started 2024-10 and due to reach its primary completion in 2026-10. Interventions recorded: Adebrelimab injection, Albumin-Bound Paclitaxel, Carboplatin injection. Conditions recorded: Resectable Esophageal Squamous Cell Carcinoma.\n\nLinked to the technology Endoscopic resection because the registry's title names it (\"endoscopic resection\") and Oesophageal squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06599775","url":"https://clinicaltrials.gov/study/NCT06599775"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["oesophageal-squamous-cell-carcinoma"],"sections":[],"technologies":["endoscopic-resection"],"targets":[],"drugs":["adebrelimab","paclitaxel","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06599775","phase":"2","setting":"Prospective, Single-arm, Multicenter Exploratory Study of Adebrelimab Combined With Chemotherapy, Endoscopic Resection and Sequential Chemoradiotherapy In the Treatment of Inoperable Clinical Staging T1b-2 Esophageal Squamous Cell Carcinoma","sponsor":"Shanghai Zhongshan Hospital","started":"2024-10","startedType":"estimated","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05317819","kind":"trial","name":"Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma","aka":[],"tldr":"A phase 3 trial testing ADI-PEG20 in hepatocellular carcinoma, now recruiting.","summary":"Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma is a phase 3 interventional study registered as NCT05317819, led by Polaris, and recruiting on the registry. Official title: A Randomised, Double-Blind, Multi-Center Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma. Planned enrolment is 300 participants (estimated). The study started in 2022-03-14 and primary completion is expected in 2028-09. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05317819","url":"https://clinicaltrials.gov/study/NCT05317819"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":["adi-peg20"],"companies":["polaris-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05317819","phase":"3","setting":"A Randomized, Double-Blind, Multi-Center Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma","sponsor":"Polaris","started":"2022-03-14","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07804186","kind":"trial","name":"Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma","aka":[],"tldr":"A phase 3 trial testing Darovasertib in uveal melanoma, now recruiting.","summary":"Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma is a phase 3 interventional study registered as NCT07804186, led by IDEAYA Biosciences, and recruiting on the registry. Official title: A Randomised, Phase 3, Open-label Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma. Planned enrolment is 450 participants (estimated). The study started in 2026-09 and primary completion is expected in 2034-03. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07804186","url":"https://clinicaltrials.gov/study/NCT07804186"}],"tags":["ctgov-ingest"],"related":[],"cancers":["uveal-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["darovasertib"],"companies":["ideaya-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07804186","phase":"3","setting":"A Randomized, Phase 3, Open-label Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma","sponsor":"IDEAYA Biosciences","started":"2026-09","startedType":"estimated","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06722911","kind":"trial","name":"Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of nimotuzumab in pancreatic cancer, run by Zhejiang Provincial People's Hospital, now recruiting.","summary":"Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer is a phase 2, interventional study registered as NCT06722911 by Zhejiang Provincial People's Hospital, with a registry enrolment figure of 57 participants, started 2024-11-15 and due to reach its primary completion in 2028-09-30. Interventions recorded: Nimotuzumab; AG. Conditions listed: Pancreatic Cancer Resectable. Primary outcome: disease-free survival (DFS). Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed resected pancreatic ductal adenocarcinoma (PDAC), resectable evaluation is based on criteria of NCCN guidelines, no evidence of distant metastasis as demonstrated by imaging;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06722911","url":"https://clinicaltrials.gov/study/NCT06722911"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["nimotuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06722911","phase":"2","setting":"Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine As Postoperative Adjuvant Therapy in Patients with EGFR-positive Pancreatic Cancer: a Prospective, Single-arm Study","sponsor":"Zhejiang Provincial People's Hospital","started":"2024-11-15","startedType":"actual","enrolled":57,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05689853","kind":"trial","name":"Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of AK119 in advanced solid tumours, run by Akeso, now recruiting.","summary":"Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05689853 by Akeso, with 87 participants planned, started 2023-04-14 and due to reach its primary completion in 2026-12. Interventions recorded: AK119 and AK112.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05689853","url":"https://clinicaltrials.gov/study/NCT05689853"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ak119"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05689853","phase":"1/2","setting":"An Open-label, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability and Antitumor Activity of AK119 in Combination With AK112 in Patients With Advanced Solid Tumors","sponsor":"Akeso","started":"2023-04-14","startedType":"actual","enrolled":87,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07284433","kind":"trial","name":"Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies","aka":["QUADvance"],"tldr":"A phase 1/2 trial of Allo-QuadCAR01-T in diffuse large B-cell lymphoma and non-Hodgkin lymphoma, run by AvenCell Therapeutics, Inc., now recruiting.","summary":"Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies is a phase 1/2 interventional study registered as NCT07284433 by AvenCell Therapeutics, Inc., with 178 participants planned, started 2026-01-06 and due to reach its primary completion in 2029-04-27. Interventions recorded: Allo-QuadCAR01-T.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07284433","url":"https://clinicaltrials.gov/study/NCT07284433"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["dlbcl","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":["cd19","cd20"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07284433","phase":"1/2","setting":"A Single-arm, Multicenter, Open-label, Phase I/II Trial of Allo-QuadCAR01-T, an Allogeneic CAR-T-cell Therapy Targeting CD19 and CD20, for the Treatment of Relapsed or Refractory B-cell Malignancies","sponsor":"AvenCell Therapeutics, Inc.","started":"2026-01-06","startedType":"actual","enrolled":178,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04208178","kind":"trial","name":"Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation","aka":["EPIK-B2"],"tldr":"A phase 3 trial of Alpelisib, Trastuzumab and Pertuzumab in HER2-positive breast cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation is a phase 3 interventional study registered as NCT04208178 by Novartis Pharmaceuticals, with 19 participants enrolled, started 2020-07-16 and due to reach its primary completion in 2027-02-26. Interventions recorded: Alpelisib, Alpelisib matching Placebo, Trastuzumab and Pertuzumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04208178","url":"https://clinicaltrials.gov/study/NCT04208178"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["kinase-inhibitors","monoclonal-antibody","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["alpelisib","trastuzumab","pertuzumab"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04208178","phase":"3","setting":"EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation","sponsor":"Novartis Pharmaceuticals","started":"2020-07-16","startedType":"actual","enrolled":19,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05776524","kind":"trial","name":"Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of nab-paclitaxel and gemcitabine in pancreatic cancer, run by THERABIONIC INC., now recruiting.","summary":"Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT05776524 by THERABIONIC INC., with a registry enrolment figure of 46 participants, started 2023-06-13 and due to reach its primary completion in 2027-07. Interventions recorded: Nab paclitaxel; Gemcitabine; TheraBionic. Conditions listed: Pancreatic Cancer; Metastatic Adenocarcinoma. Primary outcome: Overall Survival. Pancreatic eligibility wording from the registry: \"* Patient must have newly diagnosed untreated biopsy proven metastatic adenocarcinoma of the pancreas\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05776524","url":"https://clinicaltrials.gov/study/NCT05776524"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["nab-paclitaxel","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05776524","phase":"2","setting":"A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer","sponsor":"THERABIONIC INC.","started":"2023-06-13","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07287917","kind":"trial","name":"Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Eflornithine, Fulvestrant, Capivasertib in melanoma and skin cancer, run by Aminex Therapeutics, Inc., now recruiting.","summary":"Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07287917 by Aminex Therapeutics, Inc., with 92 participants planned, started 2026-01-26 and due to reach its primary completion in 2028-02-28. Interventions recorded: AMXT 1501 Dicaprate, DFMO, Fulvestrant, Capivasertib, Pembrolizumab. Conditions listed: Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07287917","url":"https://clinicaltrials.gov/study/NCT07287917"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","skin-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["eflornithine","fulvestrant","capivasertib","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07287917","phase":"1/2","setting":"A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies","sponsor":"Aminex Therapeutics, Inc.","started":"2026-01-26","startedType":"actual","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07346144","kind":"trial","name":"Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma","aka":["ADePT"],"tldr":"A phase 1/2 trial of TGX-007 in glioma & glioblastoma, run by Trogenix ltd, now recruiting.","summary":"Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma is a phase 1/2 interventional study registered as NCT07346144 by Trogenix ltd, with 68 participants planned, started 2026-04-21 and due to reach its primary completion in 2030-03. Interventions recorded: TGX-007 and Valaciclovir.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07346144","url":"https://clinicaltrials.gov/study/NCT07346144"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["trog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07346144","phase":"1/2","setting":"A Phase I/II Study of an AAV-1 Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma","sponsor":"Trogenix ltd","started":"2026-04-21","startedType":"actual","enrolled":68,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03836352","kind":"trial","name":"Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recur","aka":[],"tldr":"A phase 2 trial of Cyclophosphamide, Pembrolizumab in ovarian cancer and hepatocellular carcinoma, run by ImmunoVaccine Technologies, Inc. (IMV Inc.), active and no longer recruiting.","summary":"Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors is a phase 2 interventional study registered as NCT03836352 by ImmunoVaccine Technologies, Inc. (IMV Inc.), with 184 participants planned, started 2018-12-21 and due to reach its primary completion in 2023-12-31. Interventions recorded: DPX-Survivac, Cyclophosphamide, Pembrolizumab. Conditions listed: Ovarian Cancer, Hepatocellular Carcinoma, Non-small Cell Lung Cancer, Bladder Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03836352","url":"https://clinicaltrials.gov/study/NCT03836352"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","hcc","nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["cyclophosphamide","pembrolizumab"],"companies":["immunovaccine"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03836352","phase":"2","setting":"A Phase 2, Open-label, Multicenter, Study of an Immunotherapeutic Treatment, DPX-Survivac in Combination With Low Dose Cyclophosphamide and Pembrolizumab, in Subjects With Selected Advanced and Recurrent Solid Tumours.","sponsor":"ImmunoVaccine Technologies, Inc. (IMV Inc.)","started":"2018-12-21","startedType":"actual","enrolled":184,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06710132","kind":"trial","name":"Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)","aka":["PROCEADE PanTumor"],"tldr":"A phase 1/2 trial of Precemtabart tocentecan in non-small-cell lung cancer and small-cell lung cancer, run by EMD Serono Research & Development Institute, Inc., active and no longer recruiting.","summary":"Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) is a phase 1/2 interventional study registered as NCT06710132 by EMD Serono Research & Development Institute, Inc., with 184 participants enrolled, started 2025-01-29 and due to reach its primary completion in 2027-12-23. Interventions recorded: M9140. Conditions listed: Solid Tumors, Gastric Cancer, Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06710132","url":"https://clinicaltrials.gov/study/NCT06710132"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["precemtabart-tocentecan"],"companies":["merck-kgaa"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06710132","phase":"1/2","setting":"PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Solid Tumors (Master Protocol)","sponsor":"EMD Serono Research & Development Institute, Inc.","started":"2025-01-29","startedType":"actual","enrolled":184,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02887040","kind":"trial","name":"Study of Antineoplaston Therapy + Radiation vs. Radiation Only in Diffuse, Intrinsic, Brainstem Glioma","aka":[],"tldr":"A phase 3 trial of Antineoplastons in Glioma & glioblastoma, run by Burzynski Research Institute, not yet recruiting.","summary":"Study of Antineoplaston Therapy + Radiation vs. Radiation Only in Diffuse, Intrinsic, Brainstem Glioma is a phase 3 interventional study registered as NCT02887040 by Burzynski Research Institute, with 92 participants planned, started 2025-10-01 and due to reach its primary completion in 2026-06. Interventions recorded: Radiation, Atengenal, Astugenal. Conditions recorded: Brain Stem Glioma.\n\nLinked to the technology Antineoplastons because the registry's title names it (\"antineoplastons\") and Glioma & glioblastoma among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02887040","url":"https://clinicaltrials.gov/study/NCT02887040"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["antineoplastons"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02887040","phase":"3","setting":"A Randomized Phase 3 Study of Combination Antineoplaston Therapy [Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal)] Plus Radiation Therapy vs. Radiation Therapy Only in Subjects With Newly Diagnosed Diffuse, Intrinsic, Brainstem Glioma","sponsor":"Burzynski Research Institute","started":"2025-10-01","startedType":"estimated","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05909332","kind":"trial","name":"Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03)","aka":["BCTOP-T-A03"],"tldr":"A phase 3 trial in triple-negative breast cancer, run by Fudan University, now recruiting.","summary":"Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03) is a phase 3, randomised interventional study registered as NCT05909332 by Fudan University, with a registry enrolment figure of 764 participants, started 2023-06-20 and due to reach its primary completion in 2029-05-30. Interventions recorded: Antivascular therapy; Chemotherapy. Conditions listed: Breast Cancer; Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Histological results recorded as TNBC (negative HER2, ER, and PgR status) and BLIS subtype according to the classification of FUSCC;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05909332","url":"https://clinicaltrials.gov/study/NCT05909332"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05909332","phase":"3","setting":"A Randomized, Open-label Phase III Clinical Trial Comparing Antivascular Therapy Combined With Standard Chemotherapy and Standard Chemotherapy in Adjuvant Therapy for Patients With Triple-Negative Breast Cancer, Basal-like Immunosuppressed Subtype (BCTOP-T-A03)","sponsor":"Fudan University","started":"2023-06-20","startedType":"actual","enrolled":764,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05147467","kind":"trial","name":"Study of APG-2575 in Patients With Relapsed/Refractory CLL/SLL","aka":[],"tldr":"A phase 2 trial of APG2575 in chronic lymphocytic leukaemia, run by Ascentage Pharma Group Inc., now recruiting.","summary":"Study of APG-2575 in Patients With Relapsed/Refractory CLL/SLL is a phase 2 interventional study registered as NCT05147467 by Ascentage Pharma Group Inc., with 75 participants planned, started 2021-12-28 and due to reach its primary completion in 2026-12. Interventions recorded: APG2575.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05147467","url":"https://clinicaltrials.gov/study/NCT05147467"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["ascentage-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05147467","phase":"2","setting":"A Single-arm, Pivotal Registration Phase II Study of the Efficacy and Safety of APG-2575 Monotherapy in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","sponsor":"Ascentage Pharma Group Inc.","started":"2021-12-28","startedType":"actual","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04494503","kind":"trial","name":"Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL","aka":[],"tldr":"A phase 1/2 trial of Rituximab and Ibrutinib in chronic lymphocytic leukaemia, run by Ascentage Pharma Group Inc., now recruiting.","summary":"Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL is a phase 1/2 interventional study registered as NCT04494503 by Ascentage Pharma Group Inc., with 123 participants planned, started 2020-08-31 and due to reach its primary completion in 2024-10-20. Interventions recorded: APG-2575, Rituximab and Ibrutinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04494503","url":"https://clinicaltrials.gov/study/NCT04494503"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":[],"targets":[],"drugs":["rituximab","ibrutinib"],"companies":["ascentage-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04494503","phase":"1/2","setting":"A Phase Ib/II Study of the Safety, Pharmacokinetic, Pharmacodynamic and Efficacy of APG-2575 Single Agent and in Combination With Other Therapeutic Agents in Patients With Relapsed/Refractory CLL/SLL","sponsor":"Ascentage Pharma Group Inc.","started":"2020-08-31","startedType":"actual","enrolled":123,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06297226","kind":"trial","name":"Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma","aka":["QUINTESSENTIAL"],"tldr":"A phase 2 trial of Arlocabtagene Autoleucel in multiple myeloma, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, now recruiting.","summary":"Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma is a phase 2 interventional study registered as NCT06297226 by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, with 230 participants planned, started 2024-03-21 and due to reach its primary completion in 2026-07-31. Interventions recorded: Arlocabtagene Autoleucel. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06297226","url":"https://clinicaltrials.gov/study/NCT06297226"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["arlocabtagene-autoleucel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06297226","phase":"2","setting":"A Phase 2, Open-Label, Multicenter Study of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)","sponsor":"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company","started":"2024-03-21","startedType":"actual","enrolled":230,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05898399","kind":"trial","name":"Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)","aka":["POLKA"],"tldr":"A phase 1/2 trial of Olaparib in advanced solid tumours, run by Artios Pharma Ltd, now recruiting.","summary":"Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA) is a phase 1/2 interventional study registered as NCT05898399 by Artios Pharma Ltd, with 181 participants planned, started 2023-06-30 and due to reach its primary completion in 2028-06-30. Interventions recorded: ART6043 and Olaparib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05898399","url":"https://clinicaltrials.gov/study/NCT05898399"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["olaparib"],"companies":["artios-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05898399","phase":"1/2","setting":"A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART6043 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors","sponsor":"Artios Pharma Ltd","started":"2023-06-30","startedType":"actual","enrolled":181,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04665856","kind":"trial","name":"Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer","aka":["SKYSCRAPER-02C"],"tldr":"A phase 3 trial of Tiragolumab, Atezolizumab, Carboplatin and Etoposide in small-cell lung cancer, run by Hoffmann-La Roche, now completed.","summary":"Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer is a phase 3 interventional study registered as NCT04665856 by Hoffmann-La Roche, with 123 participants enrolled, started 2020-12-21 and reached its primary completion in 2023-08-31. Interventions recorded: Tiragolumab, Atezolizumab, Carboplatin, Etoposide and Tiragolumab Matching Placebo. Results have been posted on the registry.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04665856","url":"https://clinicaltrials.gov/study/NCT04665856"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","tigit-blockade","topoisomerase-inhibitors"],"targets":[],"drugs":["tiragolumab","atezolizumab","carboplatin","etoposide"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04665856-j-thorac-oncol-2026"],"journals":[],"dependsOn":[],"notes":["Registry status on 22 September 2026: Completed (registry record last updated 18 September 2026; primary completion reached 31 August 2023)."],"nct":"NCT04665856","phase":"3","setting":"A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer","sponsor":"Hoffmann-La Roche","started":"2020-12-21","startedType":"actual","yearReported":2025,"enrolled":123,"enrolledBasis":"registry","outcomes":[{"endpoint":"Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS)","primary":true,"unit":"months","arms":[{"name":"Placebo + Atezolizumab + Carboplatin + Etoposide","n":56,"value":5.39,"note":"95% CI 4.30 to 6.77; Figures from the ClinicalTrials.gov results section (first posted 2025-10-29), not from a publication"},{"name":"Tiragolumab + Atezolizumab + Carboplatin + Etoposide","n":54,"value":5.59,"note":"95% CI 4.53 to 7.89"}],"hr":0.65,"ci":[0.43,0.97],"p":"0.0348","source":"https://clinicaltrials.gov/study/NCT04665856?tab=results"},{"endpoint":"Overall Survival (OS) in the PAS","primary":true,"unit":"months","arms":[{"name":"Placebo + Atezolizumab + Carboplatin + Etoposide","n":56,"value":13.54,"note":"95% CI 10.35 to 22.44; Figures from the ClinicalTrials.gov results section (first posted 2025-10-29), not from a publication"},{"name":"Tiragolumab + Atezolizumab + Carboplatin + Etoposide","n":54,"value":18.69,"note":"95% CI 14.26 to 20.86"}],"hr":0.89,"ci":[0.56,1.4],"p":"0.6105","source":"https://clinicaltrials.gov/study/NCT04665856?tab=results"},{"endpoint":"Investigator-assessed Confirmed Objective Response Rate (ORR) in the PAS","unit":"%","arms":[{"name":"Placebo + Atezolizumab + Carboplatin + Etoposide","n":56,"value":58.9,"note":"95% CI 45.01 to 71.63; Figures from the ClinicalTrials.gov results section (first posted 2025-10-29), not from a publication"},{"name":"Tiragolumab + Atezolizumab + Carboplatin + Etoposide","n":54,"value":81.5,"note":"95% CI 68.13 to 90.30"}],"p":"0.0136","source":"https://clinicaltrials.gov/study/NCT04665856?tab=results"}]},{"id":"nct05267626","kind":"trial","name":"Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Ca","aka":[],"tldr":"A phase 1/2 trial of Aldesleukin, Avelumab, Nivolumab in metastatic cancer and melanoma, run by Aulos Bioscience, Inc., now recruiting.","summary":"Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer is a phase 1/2 interventional study registered as NCT05267626 by Aulos Bioscience, Inc., with 159 participants planned, started 2022-04-04 and due to reach its primary completion in 2027-02-28. Interventions recorded: AU-007, Aldesleukin, Avelumab, Nivolumab. Conditions listed: Advanced Solid Tumor, Metastatic Cancer, Cutaneous Melanoma, Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05267626","url":"https://clinicaltrials.gov/study/NCT05267626"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","melanoma","nsclc","sclc"],"sections":[],"technologies":["cytokine-therapy","til-therapy"],"targets":[],"drugs":["aldesleukin","avelumab","nivolumab","au-007"],"companies":["aulos-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05267626","phase":"1/2","setting":"A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer","sponsor":"Aulos Bioscience, Inc.","started":"2022-04-04","startedType":"actual","enrolled":159,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05669482","kind":"trial","name":"Study of Avutometinib (VS-6766) +Defactinib With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer","aka":["RAMP205"],"tldr":"A phase 1/2 trial of Gemcitabine, Paclitaxel / nab-paclitaxel in metastatic cancer, run by Verastem, Inc., active and no longer recruiting.","summary":"Study of Avutometinib (VS-6766) +Defactinib With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer is a phase 1/2 interventional study registered as NCT05669482 by Verastem, Inc., with 40 participants planned, started 2023-03-22 and due to reach its primary completion in 2026-08-31. Interventions recorded: avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel. Conditions listed: KRAS Activating Mutation, Metastatic Cancer, Pancreas Cancer, Neoplasms Pancreatic. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05669482","url":"https://clinicaltrials.gov/study/NCT05669482"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","paclitaxel"],"companies":["verastem"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05669482","phase":"1/2","setting":"A Phase 1b/2a Study of Gemcitabine and Nab-paclitaxel in Combination With Avutometinib (VS-6766) and Defactinib in Patients With Previously Untreated Metastatic Adenocarcinoma of the Pancreas","sponsor":"Verastem, Inc.","started":"2023-03-22","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05867251","kind":"trial","name":"Study of AVZO-021 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of AVZO-021, Palbociclib, Fulvestrant in ovarian cancer and endometrial cancer, run by Avenzo Therapeutics, Inc., now recruiting.","summary":"Study of AVZO-021 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05867251 by Avenzo Therapeutics, Inc., with 430 participants planned, started 2023-08-30 and due to reach its primary completion in 2028-01-31. Interventions recorded: AVZO-021, Palbociclib, Fulvestrant, Letrozole, Ribociclib. Conditions listed: Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer, CCNE1 Amplification. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05867251","url":"https://clinicaltrials.gov/study/NCT05867251"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","endometrial"],"sections":[],"technologies":[],"targets":[],"drugs":["avzo-021","palbociclib","fulvestrant","letrozole","ribociclib","abemaciclib"],"companies":["avenzo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05867251","phase":"1/2","setting":"A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced Solid Tumors","sponsor":"Avenzo Therapeutics, Inc.","started":"2023-08-30","startedType":"actual","enrolled":430,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05371093","kind":"trial","name":"Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma","aka":["ZUMA-22"],"tldr":"A phase 3 trial of Axicabtagene ciloleucel, Cyclophosphamide, Fludarabine in follicular lymphoma, run by Kite, A Gilead Company, active and no longer recruiting.","summary":"Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma is a phase 3 interventional study registered as NCT05371093 by Kite, A Gilead Company, with 231 participants enrolled, started 2022-09-22 and due to reach its primary completion in 2030-10. Interventions recorded: Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Lenalidomide, Rituximab. Conditions listed: Relapsed/Refractory Follicular Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05371093","url":"https://clinicaltrials.gov/study/NCT05371093"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["axicabtagene-ciloleucel","cyclophosphamide","fludarabine","lenalidomide","rituximab","doxorubicin"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05371093","phase":"3","setting":"A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma","sponsor":"Kite, A Gilead Company","started":"2022-09-22","startedType":"actual","enrolled":231,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05433532","kind":"trial","name":"Study of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients","aka":[],"tldr":"A phase 2 trial of Azacitidine, Venetoclax and Flumatinib in Acute myeloid leukaemia, Acute lymphoblastic leukaemia, Chronic myeloid leukaemia and Leukaemia, run by The First Affiliated Hospital of Soochow University, completed.","summary":"Study of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients is a phase 2 interventional study registered as NCT05433532 by The First Affiliated Hospital of Soochow University, with 20 participants recorded, started 2022-05-01 and reaching its primary completion in 2024-04-13. Interventions recorded: Azacitidine, Venetoclax, Flumatinib. Conditions recorded: Philadelphia Chromosome, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Mixed Phenotype Acute Leukemia.\n\nLinked to the drug Flumatinib because the registry names it among its interventions and Acute myeloid leukaemia, Acute lymphoblastic leukaemia, Chronic myeloid leukaemia and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05433532","url":"https://clinicaltrials.gov/study/NCT05433532"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","all-leukemia","cml","leukaemia","cml-advanced-phase"],"sections":[],"technologies":[],"targets":[],"drugs":["azacitidine","venetoclax","flumatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05433532","phase":"2","setting":"A Phase Ⅱ, Open Label, Single Arm, Single-Center Study to Evaluate the Efficacy and Safety of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients","sponsor":"The First Affiliated Hospital of Soochow University","started":"2022-05-01","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07764978","kind":"trial","name":"Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT","aka":["DURGA-5"],"tldr":"A phase 3 trial of Daratumumab, Dexamethasone, Isatuximab in multiple myeloma, run by AstraZeneca, now recruiting.","summary":"Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT is a phase 3 interventional study registered as NCT07764978 by AstraZeneca, with 750 participants planned, started 2026-06-26 and due to reach its primary completion in 2029-01-11. Interventions recorded: AZD0120, Daratumumab, Dexamethasone, Isatuximab, Lenalidomide. Conditions listed: Newly Diagnosed Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07764978","url":"https://clinicaltrials.gov/study/NCT07764978"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["daratumumab","dexamethasone","isatuximab","lenalidomide","bortezomib","cyclophosphamide"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07764978","phase":"3","setting":"Phase III Open-Label, Randomised Study of Consolidation With AZD0120 (Dual-Targeting BCMA/CD19 CAR-T) vs Continuous Standard Therapy in NDMM Patients Ineligible for ASCT as Initial Therapy (DURGA-5)","sponsor":"AstraZeneca","started":"2026-06-26","startedType":"actual","enrolled":750,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07181161","kind":"trial","name":"Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer","aka":["SEACLIFF"],"tldr":"A phase 1/2 trial of Palacaparib in prostate cancer, run by AstraZeneca, now recruiting.","summary":"Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer is a phase 1/2 interventional study registered as NCT07181161 by AstraZeneca, with 283 participants planned, started 2025-10-01 and due to reach its primary completion in 2029-01-18. Interventions recorded: AZD0516, AZD9574. Conditions listed: Metastatic Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07181161","url":"https://clinicaltrials.gov/study/NCT07181161"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["palacaparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07181161","phase":"1/2","setting":"A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Metastatic Prostate Cancer","sponsor":"AstraZeneca","started":"2025-10-01","startedType":"actual","enrolled":283,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06267729","kind":"trial","name":"Study of AZD0754 in Participants With Metastatic Prostate Cancer","aka":["APOLLO"],"tldr":"A phase 1/2 trial of AZD0754 in prostate cancer, run by AstraZeneca, now recruiting.","summary":"Study of AZD0754 in Participants With Metastatic Prostate Cancer is a phase 1/2 interventional study registered as NCT06267729 by AstraZeneca, with 60 participants planned, started 2024-03-12 and due to reach its primary completion in 2026-11-24. Interventions recorded: AZD0754 and AZD2287.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06267729","url":"https://clinicaltrials.gov/study/NCT06267729"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06267729","phase":"1/2","setting":"A Phase I/II Open Label Study to Evaluate the Safety, Cellular Kinetics, and Efficacy of AZD0754, a Chimeric Antigen Receptor (CAR) T-cell Therapy Directed Against STEAP2, in Adult Participants With Metastatic Prostate Cancer: APOLLO","sponsor":"AstraZeneca","started":"2024-03-12","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04745689","kind":"trial","name":"Study of AZD2811 + Durvalumab in ES-SCLC","aka":["TAZMAN"],"tldr":"A phase 2 trial of Durvalumab, Carboplatin, Cisplatin in small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study of AZD2811 + Durvalumab in ES-SCLC is a phase 2 interventional study registered as NCT04745689 by AstraZeneca, with 31 participants enrolled, started 2021-02-23 and due to reach its primary completion in 2022-06-18. Interventions recorded: Durvalumab, AZD2811, Carboplatin, Cisplatin, Etoposide. Conditions listed: Small-Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04745689","url":"https://clinicaltrials.gov/study/NCT04745689"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","carboplatin","cisplatin","etoposide"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04745689","phase":"2","setting":"A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction With Platinum-Based Chemotherapy Combined With Durvalumab, for the First-Line Treatment of Patients With Extensive Stage Small-Cell Lung Cancer","sponsor":"AstraZeneca","started":"2021-02-23","startedType":"actual","yearReported":2025,"enrolled":31,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS) in Maintenance Participants","unit":"months","arms":[{"name":"AZD2811 + Durvalumab","n":9,"value":9.99,"note":"95% CI 4.14 to NA; Figures from the ClinicalTrials.gov results section (first posted 2025-03-27), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04745689?tab=results"}]},{"id":"nct07155226","kind":"trial","name":"Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression","aka":[],"tldr":"A phase 1/2 trial of AZD3632 in acute lymphoblastic leukaemia, acute myeloid leukaemia and myelodysplastic syndromes / neoplasms, run by AstraZeneca, now recruiting.","summary":"Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression is a phase 1/2 interventional study registered as NCT07155226 by AstraZeneca, with 84 participants planned, started 2026-01-09 and due to reach its primary completion in 2029-02-15. Interventions recorded: AZD3632 and Posaconazole.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07155226","url":"https://clinicaltrials.gov/study/NCT07155226"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","aml","mds"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07155226","phase":"1/2","setting":"A Modular Phase I/II, Open-label, Multi-Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression","sponsor":"AstraZeneca","started":"2026-01-09","startedType":"actual","enrolled":84,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07109219","kind":"trial","name":"Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia","aka":["ALLight"],"tldr":"A phase 1/2 trial of AZD4512 in acute lymphoblastic leukaemia, run by AstraZeneca, now recruiting.","summary":"Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia is a phase 1/2 interventional study registered as NCT07109219 by AstraZeneca, with 83 participants planned, started 2025-11-12 and due to reach its primary completion in 2028-04-28. Interventions recorded: AZD4512 monotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07109219","url":"https://clinicaltrials.gov/study/NCT07109219"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":[],"targets":[],"drugs":["azd4512"],"companies":["astrazeneca","fortrea"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07109219","phase":"1/2","setting":"A Modular Phase I/II, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AZD4512 Monotherapy or in Combination With Anticancer Agent(s) in Participants With Acute Lymphoblastic Leukemia","sponsor":"AstraZeneca","started":"2025-11-12","startedType":"actual","enrolled":83,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07446855","kind":"trial","name":"Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours","aka":["PARTHENON"],"tldr":"A phase 1/2 trial of Saruparib in advanced solid tumours, run by AstraZeneca, now recruiting.","summary":"Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours is a phase 1/2 interventional study registered as NCT07446855 by AstraZeneca, with 180 participants planned, started 2026-03-17 and due to reach its primary completion in 2030-03-29. Interventions recorded: AZD4956 and Saruparib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07446855","url":"https://clinicaltrials.gov/study/NCT07446855"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["saruparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07446855","phase":"1/2","setting":"A Modular Open-label, Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Ascending Doses of AZD4956 as Monotherapy, and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Repair Defective Solid Tumours","sponsor":"AstraZeneca","started":"2026-03-17","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04644068","kind":"trial","name":"Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies","aka":["PETRA"],"tldr":"A phase 1/2 trial of Saruparib, Paclitaxel / nab-paclitaxel, Carboplatin in ovarian cancer and prostate cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies is a phase 1/2 interventional study registered as NCT04644068 by AstraZeneca, with 702 participants enrolled, started 2020-11-12 and due to reach its primary completion in 2027-05-28. Interventions recorded: AZD5305, Paclitaxel, Carboplatin, T- Dxd, Dato-DXd. Conditions listed: Ovarian Cancer, Breast Cancer, Pancreatic Cancer, Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04644068","url":"https://clinicaltrials.gov/study/NCT04644068"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","prostate","nsclc","sclc","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["saruparib","paclitaxel","carboplatin","trastuzumab-deruxtecan","datopotamab-deruxtecan","camizestrant"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04644068","phase":"1/2","setting":"A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies","sponsor":"AstraZeneca","started":"2020-11-12","startedType":"actual","enrolled":702,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05367440","kind":"trial","name":"Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer","aka":["PETRANHA"],"tldr":"A phase 1/2 trial of Saruparib, Enzalutamide, Abiraterone acetate in prostate cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer is a phase 1/2 interventional study registered as NCT05367440 by AstraZeneca, with 174 participants enrolled, started 2022-06-02 and due to reach its primary completion in 2031-04-11. Interventions recorded: AZD5305, Enzalutamide, Abiraterone Acetate, Darolutamide, Apalutamide. Conditions listed: Metastatic Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05367440","url":"https://clinicaltrials.gov/study/NCT05367440"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["saruparib","enzalutamide","abiraterone","darolutamide","apalutamide"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05367440","phase":"1/2","setting":"A Multi-arm, Open-label Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD5305 in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (PETRANHA)","sponsor":"AstraZeneca","started":"2022-06-02","startedType":"actual","enrolled":174,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06005493","kind":"trial","name":"Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of AZD5863 in pancreatic ductal adenocarcinoma, run by AstraZeneca, now recruiting.","summary":"Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06005493 by AstraZeneca, with 280 participants planned, started 2023-07-11 and due to reach its primary completion in 2027-07-16. Interventions recorded: AZD5863. Conditions listed: Gastric Cancer, Gastro-esophageal Junction Cancer, Pancreatic Ductal Adenocarcinoma, Esophageal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06005493","url":"https://clinicaltrials.gov/study/NCT06005493"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["azd5863"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06005493","phase":"1/2","setting":"A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5863, a T Cell-engaging Bispecific Antibody That Targets Claudin 18.2 (CLDN18.2) and CD3 in Adult Participants With Advanced or Metastatic Solid Tumors","sponsor":"AstraZeneca","started":"2023-07-11","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05417594","kind":"trial","name":"Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies","aka":["CERTIS1"],"tldr":"A phase 1/2 trial of Palacaparib, Temozolomide, Trastuzumab, Trastuzumab deruxtecan and Datopotamab deruxtecan in advanced solid tumours, run by AstraZeneca, now recruiting.","summary":"Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies is a phase 1/2 interventional study registered as NCT05417594 by AstraZeneca, with 695 participants planned, started 2022-06-24 and due to reach its primary completion in 2028-02-07. Interventions recorded: AZD9574, Temozolomide (TMZ), [11C]AZ1419 3391, Trastuzumab Deruxtecan (T-DXd) and Datopotamab Deruxtecan (Dato-DXd).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05417594","url":"https://clinicaltrials.gov/study/NCT05417594"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["palacaparib","temozolomide","trastuzumab","trastuzumab-deruxtecan","datopotamab-deruxtecan"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05417594","phase":"1/2","setting":"A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (CERTIS1)","sponsor":"AstraZeneca","started":"2022-06-24","startedType":"actual","enrolled":695,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06706713","kind":"trial","name":"Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of BEBT-109 Capsule in non-small-cell lung cancer, run by BeBetter Med Inc, now recruiting.","summary":"Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT06706713 by BeBetter Med Inc, with 200 participants planned, started 2022-04-15 and due to reach its primary completion in 2025-12-31. Interventions recorded: BEBT-109 Capsule.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06706713","url":"https://clinicaltrials.gov/study/NCT06706713"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bebetter-med"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06706713","phase":"2","setting":"An Apen-label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of BEBT-109 in Patients With EGFR Exon 20 Insertion Mutations in Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"BeBetter Med Inc","started":"2022-04-15","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06514027","kind":"trial","name":"Study of BEBT-109 in Subjects With Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations","aka":[],"tldr":"A phase 2 trial of Pemetrexed, Carboplatin, Cisplatin in non-small-cell lung cancer and small-cell lung cancer, run by BeBetter Med Inc, now recruiting.","summary":"Study of BEBT-109 in Subjects With Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations is a phase 2 interventional study registered as NCT06514027 by BeBetter Med Inc, with 30 participants planned, started 2024-08-28 and due to reach its primary completion in 2027-06. Interventions recorded: BEBT-109 Capsules, Pemetrexed Disodium for Injection, Carboplatin Injection, Cisplatin Injection. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06514027","url":"https://clinicaltrials.gov/study/NCT06514027"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pemetrexed","carboplatin","cisplatin"],"companies":["bebetter-med"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06514027","phase":"2","setting":"A Multicenter, Open Phase II Clinical Study on the Safety and Efficacy of BEBT-109 Combined With Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations","sponsor":"BeBetter Med Inc","started":"2024-08-28","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06998108","kind":"trial","name":"Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Patients With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed After Prior Endocrine Therapy","aka":[],"tldr":"A phase 3 trial testing BEBT-209 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Patients With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed After Prior Endocrine Therapy is a phase 3 interventional study registered as NCT06998108, led by BeBetter Med with Chinese Academy of Medical Sciences, and recruiting on the registry. Official title: A Multicenter, Randomised, Controlled, Double-blind Phase III Clinical Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant for the Treatment of HR+/HER2- Locally Advanced or Metastatic Breast Cancer in Patients With Disease Progression After Prior Endocrine Therapy. Planned enrolment is 330 participants (estimated). The study started in 2022-06-09 and primary completion is expected in 2025-12-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06998108","url":"https://clinicaltrials.gov/study/NCT06998108"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["bebt-209"],"companies":["bebetter-med"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06998108","phase":"3","setting":"A Multicenter, Randomized, Controlled, Double-blind Phase III Clinical Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant for the Treatment of HR+/HER2- Locally Advanced or Metastatic Breast Cancer in Patients With Disease Progression After Prior Endocrine Therapy","sponsor":"BeBetter Med","started":"2022-06-09","startedType":"actual","enrolled":330,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07598318","kind":"trial","name":"Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations","aka":[],"tldr":"A phase 2/3 trial of pucotenlimab, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by Sir Run Run Shaw Hospital, not yet recruiting.","summary":"Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations is a phase 2/3, randomised interventional study registered as NCT07598318 by Sir Run Run Shaw Hospital, with a registry enrolment figure of 164 participants, started 2026-05-20 and due to reach its primary completion in 2027-12-31. Interventions recorded: Becotatug Vedotin, Pucotenlimab, Gemcitabine, Cisplatin. Conditions listed: Cholangiocarcinoma. Gallbladder cancer is named in the registry entry: \"* Histologically confirmed unresectable or metastatic cholangiocarcinoma (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma), histologically confirmed unresectable or meta\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07598318","url":"https://clinicaltrials.gov/study/NCT07598318"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pucotenlimab","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07598318","phase":"2/3","setting":"A Randomized, Controlled, Open-Label, Multi-center Study of Becotatug Vedotin (EGFR-ADC) Combined With Chemo and Immunotherapy vs. Chemo and Immunotherapy as First-Line Treatment in Advanced/Metastatic EGFR-Mutated Biliary Tract Cancer","sponsor":"Sir Run Run Shaw Hospital","started":"2026-05-20","startedType":"estimated","enrolled":164,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06428396","kind":"trial","name":"Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)","aka":["LITESPARK-029"],"tldr":"A phase 2 trial of Belzutifan, Fulvestrant, Everolimus and Exemestane in advanced solid tumours, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029) is a phase 2 interventional study registered as NCT06428396 by Merck Sharp & Dohme LLC, with 120 participants enrolled, started 2024-11-27 and due to reach its primary completion in 2027-05-05. Interventions recorded: Belzutifan, Fulvestrant, Everolimus and Exemestane.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06428396","url":"https://clinicaltrials.gov/study/NCT06428396"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy","kinase-inhibitors"],"targets":[],"drugs":["belzutifan","fulvestrant","everolimus","exemestane"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06428396","phase":"2","setting":"A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (LITESPARK-029)","sponsor":"Merck Sharp & Dohme LLC","started":"2024-11-27","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05588388","kind":"trial","name":"Study of Bevacizumab in Combination With Chemoimmunotherapy and Atezolizumab in Patients With Extensive Stage Small Cell Lung Cancer and Liver Metastases","aka":["BELIEVE"],"tldr":"A phase 2 trial of bevacizumab in lung cancer, run by Kamya Sankar, now recruiting.","summary":"Study of Bevacizumab in Combination With Chemoimmunotherapy and Atezolizumab in Patients With Extensive Stage Small Cell Lung Cancer and Liver Metastases is a phase 2, interventional study registered as NCT05588388 by Kamya Sankar, with a registry enrolment figure of 39 participants, started 2024-08-11 and due to reach its primary completion in 2026-12-28. Interventions recorded: Bevacizumab. Conditions listed: Extensive-stage Small-cell Lung Cancer; Liver Metastases. Primary outcome: 6- month Progression Free Survival (PFS) rate. Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group staging system), and radiographic confirmation of LM at diagnosis\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05588388","url":"https://clinicaltrials.gov/study/NCT05588388"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05588388","phase":"2","setting":"IIT2022-05-Sankar-BELIEVE: Phase II Study of Bevacizumab in Combination With Chemoimmunotherapy and Maintenance Atezolizumab in Patients With Extensive Stage Small Cell Lung Cancer and Liver Metastases","sponsor":"Kamya Sankar","started":"2024-08-11","startedType":"actual","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05479994","kind":"trial","name":"Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","aka":[],"tldr":"A phase 2 trial of Sonrotoclax in non-Hodgkin lymphoma and chronic lymphocytic leukaemia, run by BeiGene, active and no longer recruiting.","summary":"Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma is a phase 2 interventional study registered as NCT05479994 by BeiGene, with 100 participants enrolled, started 2022-10-25 and due to reach its primary completion in 2025-01-24. Interventions recorded: BGB-11417.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05479994","url":"https://clinicaltrials.gov/study/NCT05479994"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","cll","cll-relapsed"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["sonrotoclax"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05479994","phase":"2","setting":"A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of BCL2 Inhibitor BGB-11417 in Adult Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","sponsor":"BeiGene","started":"2022-10-25","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05471843","kind":"trial","name":"Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma","aka":[],"tldr":"A phase 1/2 trial of Sonrotoclax in mantle cell lymphoma, run by BeiGene, active and no longer recruiting.","summary":"Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma is a phase 1/2 interventional study registered as NCT05471843 by BeiGene, with 125 participants enrolled, started 2022-09-05 and due to reach its primary completion in 2025-07-18. Interventions recorded: BGB-11417. Conditions listed: Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma (MCL), Relapsed Mantle Cell Lymphoma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05471843","url":"https://clinicaltrials.gov/study/NCT05471843"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["sonrotoclax"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05471843","phase":"1/2","setting":"A Single-Arm, Open-Label, Multicenter Phase 1/2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BCL2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma","sponsor":"BeiGene","started":"2022-09-05","startedType":"actual","yearReported":2026,"enrolled":125,"enrolledBasis":"registry","outcomes":[{"endpoint":"Part 2: Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC)","primary":true,"unit":"%","arms":[{"name":"Part 2: Sonrotoclax 320 mg (Daily Ramp-up)","n":43,"value":44.2,"note":"95% CI 29.1 to 60.1; Figures from the ClinicalTrials.gov results section (first posted 2026-09-22), not from a publication"},{"name":"Part 2: Sonrotoclax 320 mg (Twice-weekly Ramp-up)","n":60,"value":58.3,"note":"95% CI 44.9 to 70.9"},{"name":"Part 2: Sonrotoclax 320 mg Total","n":103,"value":52.4,"note":"95% CI 42.4 to 62.4"}],"source":"https://clinicaltrials.gov/study/NCT05471843?tab=results"},{"endpoint":"Part 1: Overall Survival (OS)","unit":"months","arms":[{"name":"Part 1: Sonrotoclax 160 mg (Daily Ramp-up)","n":10,"value":11.4,"note":"95% CI 0.7 to NA; Figures from the ClinicalTrials.gov results section (first posted 2026-09-22), not from a publication"},{"name":"Part 1: Sonrotoclax 320 mg (Daily Ramp-up)","n":12,"value":9.5,"note":"95% CI 0.7 to NA"}],"source":"https://clinicaltrials.gov/study/NCT05471843?tab=results"}]},{"id":"nct07435038","kind":"trial","name":"Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Betta Pharmaceuticals Co., Ltd., now recruiting.","summary":"Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS is a phase 1/2, interventional study registered as NCT07435038 by Betta Pharmaceuticals Co., Ltd., with a registry enrolment figure of 120 participants, started 2026-01-29 and due to reach its primary completion in 2028-12-28. Interventions recorded: BPI-572270. Conditions listed: Non-small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC); Pancreatic Ductal Adenocarcinoma (PDAC); Advanced Solid Tumors. Primary outcome: DLT; RP2D; ORR. Sites: Australia, China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07435038","url":"https://clinicaltrials.gov/study/NCT07435038"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["betta"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07435038","phase":"1/2","setting":"A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS.","sponsor":"Betta Pharmaceuticals Co., Ltd.","started":"2026-01-29","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04662255","kind":"trial","name":"Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)","aka":["BRUIN MCL-321"],"tldr":"A phase 3 trial of Pirtobrutinib, Ibrutinib, Acalabrutinib and Zanubrutinib in mantle cell lymphoma, run by Loxo Oncology, Inc., active and no longer recruiting.","summary":"Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) is a phase 3 interventional study registered as NCT04662255 by Loxo Oncology, Inc., with 500 participants enrolled, started 2021-04-08 and due to reach its primary completion in 2027-01. Interventions recorded: Pirtobrutinib, Ibrutinib, Acalabrutinib and Zanubrutinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04662255","url":"https://clinicaltrials.gov/study/NCT04662255"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["pirtobrutinib","ibrutinib","acalabrutinib","zanubrutinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04662255","phase":"3","setting":"A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)","sponsor":"Loxo Oncology, Inc.","started":"2021-04-08","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00889525","kind":"trial","name":"Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor","aka":[],"tldr":"A phase 3 trial of Cabergoline in Pituitary tumours, run by Seth Gordhandas Sunderdas Medical College, completed.","summary":"Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor is a phase 3 interventional study registered as NCT00889525 by Seth Gordhandas Sunderdas Medical College, started 2007-11. Interventions recorded: Cabergoline. Conditions recorded: Cushing's Disease, Corticotroph Adenoma.\n\nLinked to the drug Cabergoline because the registry names it among its interventions and Pituitary tumours among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00889525","url":"https://clinicaltrials.gov/study/NCT00889525"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pituitary-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["cabergoline"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00889525","phase":"3","setting":"Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor","sponsor":"Seth Gordhandas Sunderdas Medical College","started":"2007-11","enrolledBasis":"registry","outcomes":[]},{"id":"nct04446117","kind":"trial","name":"Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC","aka":["CONTACT-02"],"tldr":"A phase 3 trial of Cabozantinib, Atezolizumab, Abiraterone acetate in prostate cancer, run by Exelixis, active and no longer recruiting.","summary":"Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC is a phase 3 interventional study registered as NCT04446117 by Exelixis, with 575 participants enrolled, started 2020-10-19 and due to reach its primary completion in 2024-04-19. Interventions recorded: Cabozantinib, Atezolizumab, Abiraterone Acetate, Enzalutamide, Prednisone. Conditions listed: Metastatic Prostate Cancer, Prostate Adenocarcinoma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04446117","url":"https://clinicaltrials.gov/study/NCT04446117"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["cabozantinib","atezolizumab","abiraterone","enzalutamide","prednisone"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04446117-lancet-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04446117","phase":"3","setting":"A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer","sponsor":"Exelixis","started":"2020-10-19","startedType":"actual","yearReported":2025,"enrolled":575,"enrolledBasis":"registry","outcomes":[{"endpoint":"Duration of Progression Free Survival (PFS) Per Response Evaluable Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Radiology Committee (BIRC)","primary":true,"unit":"months","arms":[{"name":"Experimental Arm: Cabozantinib and Atezolizumab","n":200,"value":6.34,"note":"95% CI 6.18 to 8.80; Figures from the ClinicalTrials.gov results section (first posted 2025-12-18), not from a publication"},{"name":"Control Arm: Second NHT","n":200,"value":4.17,"note":"95% CI 3.71 to 5.65"}],"p":"0.0007","source":"https://clinicaltrials.gov/study/NCT04446117?tab=results"},{"endpoint":"Duration of Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Experimental Arm: Cabozantinib and Atezolizumab","n":289,"value":14.78,"note":"95% CI 13.37 to 16.66; Figures from the ClinicalTrials.gov results section (first posted 2025-12-18), not from a publication"},{"name":"Control Arm: Second NHT","n":286,"value":14.98,"note":"95% CI 13.01 to 18.50"}],"p":"0.2956","source":"https://clinicaltrials.gov/study/NCT04446117?tab=results"}]},{"id":"nct03755791","kind":"trial","name":"Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Rece","aka":["COSMIC-312"],"tldr":"A phase 3 trial of Cabozantinib, Sorafenib, Atezolizumab in hepatocellular carcinoma, run by Exelixis, active and no longer recruiting.","summary":"Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy is a phase 3 interventional study registered as NCT03755791 by Exelixis, with 837 participants enrolled, started 2018-06-10 and due to reach its primary completion in 2021-11-30. Interventions recorded: Cabozantinib, Cabozantinib, Sorafenib, Atezolizumab. Conditions listed: Hepatocellular Carcinoma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03755791","url":"https://clinicaltrials.gov/study/NCT03755791"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["cabozantinib","sorafenib","atezolizumab"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03755791","phase":"3","setting":"A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy","sponsor":"Exelixis","started":"2018-06-10","startedType":"actual","yearReported":2025,"enrolled":837,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population","primary":true,"unit":"months","arms":[{"name":"Experimental Arm: Cabozantinib + Atezolizumab","n":250,"value":6.8,"note":"99% CI 5.55 to 8.34; Figures from the ClinicalTrials.gov results section (first posted 2025-12-11), not from a publication"},{"name":"Control Arm: Sorafenib","n":122,"value":4.21,"note":"99% CI 2.79 to 7.03"}],"hr":0.63,"p":"0.0012","source":"https://clinicaltrials.gov/study/NCT03755791?tab=results"},{"endpoint":"Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population","primary":true,"unit":"months","arms":[{"name":"Experimental Arm: Cabozantinib + Atezolizumab","n":432,"value":16.46,"note":"96% CI 14.46 to 18.56; Figures from the ClinicalTrials.gov results section (first posted 2025-12-11), not from a publication"},{"name":"Control Arm: Sorafenib","n":217,"value":15.51,"note":"96% CI 12.19 to 19.98"}],"hr":0.99,"p":"0.9056","source":"https://clinicaltrials.gov/study/NCT03755791?tab=results"}]},{"id":"nct06202313","kind":"trial","name":"Study of Cadonilimab (AK104) Plus Eribulin vs. Eribulin Monotherapy for Recurrent or Metastatic Triple-negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of cadonilimab and eribulin in triple-negative breast cancer, run by Shengjing Hospital, not yet recruiting.","summary":"Study of Cadonilimab (AK104) Plus Eribulin vs. Eribulin Monotherapy for Recurrent or Metastatic Triple-negative Breast Cancer is a phase 2, randomised interventional study registered as NCT06202313 by Shengjing Hospital, with a registry enrolment figure of 128 participants, started 2024-02-10 and due to reach its primary completion in 2025-12-30. Interventions recorded: Cadonilimab; Eribulin. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Recurrent or metastatic incurable triple negative breast cancer confirmed by histology and/or cytology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06202313","url":"https://clinicaltrials.gov/study/NCT06202313"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["cadonilimab","eribulin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06202313","phase":"2","setting":"A Multicenter, Randomized, Controlled, Open Label Clinical Study on the Treatment of Recurrent or Metastatic Triple Negative Breast Cancer With Cadonilimab Combined With Eribulin Versus Eribulin Alone","sponsor":"Shengjing Hospital","started":"2024-02-10","startedType":"estimated","enrolled":128,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05447702","kind":"trial","name":"Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)","aka":[],"tldr":"A phase 2 trial of camrelizumab, rivoceranib (apatinib), nab-paclitaxel, epirubicin and other drugs in triple-negative breast cancer, run by West China Hospital, now recruiting.","summary":"Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) is a phase 2, interventional study registered as NCT05447702 by West China Hospital, with a registry enrolment figure of 35 participants, started 2022-11-01 and due to reach its primary completion in 2023-12-31. Interventions recorded: Camrelizumab; Apatinib; Nab-paclitaxel; Epirubicin; Cyclophosphamide. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05447702","url":"https://clinicaltrials.gov/study/NCT05447702"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["camrelizumab","rivoceranib","nab-paclitaxel","epirubicin","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05447702","phase":"2","setting":"A Single-arm, Prospective Phase II Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy for Triple Negative Breast Cancer (TNBC)","sponsor":"West China Hospital","started":"2022-11-01","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06313463","kind":"trial","name":"Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy","aka":[],"tldr":"A phase 3 trial of capecitabine in triple-negative breast cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, now recruiting.","summary":"Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy is a phase 3, randomised interventional study registered as NCT06313463 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, with a registry enrolment figure of 375 participants, started 2024-03 and due to reach its primary completion in 2031-09. Interventions recorded: Carrellizumab + Capecitabine; Placebo + Capecitabine. Conditions listed: Breast Neoplasms. Triple-negative eligibility wording from the registry: \"* Confirmation of TNBC diagnosis and TLS and PD-L1 status through central examination of representative tumor tissue specimens resected during surgery\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06313463","url":"https://clinicaltrials.gov/study/NCT06313463"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06313463","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Camrelizumab and Capecitabine Versus Capecitabine as Adjuvant Therapy in Early-stage Triple-negative Breast Cancer Patients With Tertiary Lymphoid Structure in Tumor Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Neoadjuvant Chemotherapy.","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","started":"2024-03","startedType":"estimated","enrolled":375,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05348577","kind":"trial","name":"Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)","aka":["CAPItello280"],"tldr":"A phase 3 trial of Capivasertib, Docetaxel in prostate cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC) is a phase 3 interventional study registered as NCT05348577 by AstraZeneca, with 1035 participants enrolled, started 2022-03-25 and due to reach its primary completion in 2026-03-04. Interventions recorded: capivasertib, docetaxel, placebo. Conditions listed: Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05348577","url":"https://clinicaltrials.gov/study/NCT05348577"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["capivasertib","docetaxel"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05348577","phase":"3","setting":"A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)","sponsor":"AstraZeneca","started":"2022-03-25","startedType":"actual","enrolled":1035,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07011719","kind":"trial","name":"Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma","aka":[],"tldr":"A phase 3 trial of Cabozantinib in renal cell carcinoma, run by Arcus Biosciences, Inc., now recruiting.","summary":"Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma is a phase 3 interventional study registered as NCT07011719 by Arcus Biosciences, Inc., with 720 participants planned, started 2025-09-08 and due to reach its primary completion in 2028-04. Interventions recorded: Casdatifan, Cabozantinib, Placebo. Conditions listed: Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07011719","url":"https://clinicaltrials.gov/study/NCT07011719"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc","clear-cell-rcc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["cabozantinib"],"companies":["arcus-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07011719","phase":"3","setting":"A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma","sponsor":"Arcus Biosciences, Inc.","started":"2025-09-08","startedType":"actual","enrolled":720,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04195347","kind":"trial","name":"Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase","aka":["CRSPA"],"tldr":"A phase 1/2 trial in pancreatic cancer, run by St. Jude Children's Research Hospital, now recruiting.","summary":"Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase is a phase 1/2, interventional study registered as NCT04195347 by St. Jude Children's Research Hospital, with a registry enrolment figure of 42 participants, started 2020-09-04 and due to reach its primary completion in 2027-01. Interventions recorded: CM4620. Conditions listed: Acute Pancreatitis. Primary outcome: The number of CTCAE grade 3-5 events; Responses to CM4620. Pancreatic eligibility wording from the registry: \"* Acute pancreatitis with elevation of amylase OR lipase ≥ 3x the upper limit of normal AND at least 1 of: abdominal pain consistent with acute pancreatitis OR imaging findings consistent with acute pancreatitis\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04195347","url":"https://clinicaltrials.gov/study/NCT04195347"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04195347","phase":"1/2","setting":"CRSPA: Phase I/II Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase","sponsor":"St. Jude Children's Research Hospital","started":"2020-09-04","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07019779","kind":"trial","name":"Study of CM518D1 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of CM518D1 in advanced solid tumours, run by Keymed Biosciences Co.Ltd, now recruiting.","summary":"Study of CM518D1 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07019779 by Keymed Biosciences Co.Ltd, with 434 participants planned, started 2025-06-27 and due to reach its primary completion in 2028-12-31. Interventions recorded: CM518D1.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07019779","url":"https://clinicaltrials.gov/study/NCT07019779"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["keymed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07019779","phase":"1/2","setting":"A Multicenter, Open-Label, Phase I/II Clinical Study to Evaluate CM518D1 in the Treatment of Patients With Advanced Solid Tumors","sponsor":"Keymed Biosciences Co.Ltd","started":"2025-06-27","startedType":"actual","enrolled":434,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05065957","kind":"trial","name":"Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2/3 trial testing D07001 in biliary tract cancer, now recruiting.","summary":"Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer is a phase 2/3 interventional study registered as NCT05065957, led by InnoPharmax, and recruiting on the registry. Official title: Open-Label, Multicenter, Phase II/III Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer After Gemcitabine and Cisplatin-Based Treatment Failure. Planned enrolment is 180 participants (estimated). The study started in 2022-03-29 and primary completion is expected in 2026-07. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05065957","url":"https://clinicaltrials.gov/study/NCT05065957"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["d07001"],"companies":["innopharmax"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05065957","phase":"2/3","setting":"Open-Label, Multicenter, Phase II/III Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer After Gemcitabine and Cisplatin-Based Treatment Failure","sponsor":"InnoPharmax","started":"2022-03-29","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02340117","kind":"trial","name":"Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of Gemcitabine in pancreatic ductal adenocarcinoma, run by SynerGene Therapeutics, Inc., active and no longer recruiting.","summary":"Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer is a phase 2 interventional study registered as NCT02340117 by SynerGene Therapeutics, Inc., with 28 participants enrolled, started 2015-01 and due to reach its primary completion in 2026-12. Interventions recorded: SGT-53, nab-paclitaxel and Gemcitabine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02340117","url":"https://clinicaltrials.gov/study/NCT02340117"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02340117","phase":"2","setting":"Phase II Study of Combined Targeted p53 Gene Therapy (SGT-53) Plus Gemcitabine/Nab-Paclitaxel for Treatment of Metastatic Pancreatic Cancer","sponsor":"SynerGene Therapeutics, Inc.","started":"2015-01","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06569420","kind":"trial","name":"Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLC","aka":[],"tldr":"A phase 3 trial of an investigational treatment in non-small-cell lung cancer, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., active and no longer recruiting.","summary":"Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLC is a phase 3 interventional study registered as NCT06569420 by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., with 275 participants enrolled, started 2021-12-31 and due to reach its primary completion in 2025-07-31.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06569420","url":"https://clinicaltrials.gov/study/NCT06569420"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","alk-positive-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shanghai-fosun-pharmaceutical-industrial-development"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06569420","phase":"3","setting":"A Randomized, Multicenter, Phase III Open-label Study: Efficacy and Safety of Comparing SAF-189s With Crizotinib in First-line Anaplastic Lymphoma Kinase-positive Advanced and Metastatic NSCLC","sponsor":"Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.","started":"2021-12-31","startedType":"actual","enrolled":275,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07030257","kind":"trial","name":"Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of CP-383 in colorectal cancer, small-cell lung cancer, head and neck squamous cell carcinoma, bladder & urothelial cancer, non-small-cell lung cancer and pancreatic ductal adenocarcinoma, run by Tasca Therapeutics, now recruiting.","summary":"Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT07030257 by Tasca Therapeutics, with 150 participants planned, started 2025-08-27 and due to reach its primary completion in 2028-08-15. Interventions recorded: CP-383.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07030257","url":"https://clinicaltrials.gov/study/NCT07030257"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","sclc","head-and-neck","urothelial","nsclc","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07030257","phase":"1/2","setting":"A Multi-Center, Open Label, Phase 1/2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors","sponsor":"Tasca Therapeutics","started":"2025-08-27","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07283835","kind":"trial","name":"Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin","aka":[],"tldr":"A phase 2 trial of Cretostimogene grenadenorepvec in bladder & urothelial cancer, run by Lepu Biopharma Co., Ltd., now recruiting.","summary":"Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin is a phase 2 interventional study registered as NCT07283835 by Lepu Biopharma Co., Ltd., with 16 participants planned, started 2025-12-04 and due to reach its primary completion in 2027-12-31. Interventions recorded: Cretostimogene Grenadenorepvec.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07283835","url":"https://clinicaltrials.gov/study/NCT07283835"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["oncolytic-virus"],"targets":[],"drugs":["cretostimogene"],"companies":["lepu-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07283835","phase":"2","setting":"A Single-arm, Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Cretostimogene Grenadenorepvec in Patients With BCG-unresponsive High-risk Non-Muscle Invasive Bladder Cancer","sponsor":"Lepu Biopharma Co., Ltd.","started":"2025-12-04","startedType":"actual","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04093167","kind":"trial","name":"Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer","aka":[],"tldr":"A phase 2/3 trial of pembrolizumab in lung cancer, run by Canadian Cancer Trials Group, active but no longer recruiting.","summary":"Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer is a phase 2/3, randomised interventional study registered as NCT04093167 by Canadian Cancer Trials Group, with a registry enrolment figure of 53 participants, started 2020-05-26 and due to reach its primary completion in 2026-12-31. Interventions recorded: Pembrolizumab. Conditions listed: Lung Cancer. Primary outcome: Stage 1: Concordance rate between molecular response and radiologic response; Stage 2: Phase II Progression-Free Survival (PFS); Stage 2: Phase III Overall Survival. Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed metastatic NSCLC\". Sites: Canada, United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04093167","url":"https://clinicaltrials.gov/study/NCT04093167"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","mrd-testing"],"targets":[],"drugs":["pembrolizumab"],"companies":["cctg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04093167","phase":"2/3","setting":"A Biomarker-Directed, Multi-Centre Phase II/III Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer","sponsor":"Canadian Cancer Trials Group","started":"2020-05-26","startedType":"actual","enrolled":53,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03600233","kind":"trial","name":"Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors","aka":[],"tldr":"A phase 2 trial of CVM-1118 in neuroendocrine tumours and pancreatic ductal adenocarcinoma, run by TaiRx, Inc., active and no longer recruiting.","summary":"Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors is a phase 2 interventional study registered as NCT03600233 by TaiRx, Inc., with 34 participants enrolled, started 2018-12-15 and due to reach its primary completion in 2024-09-30. Interventions recorded: CVM-1118.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03600233","url":"https://clinicaltrials.gov/study/NCT03600233"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["tairx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03600233","phase":"2","setting":"A Phase II, Open-label Study of CVM-1118 Administered Orally to Patients With Advanced Neuroendocrine Tumors","sponsor":"TaiRx, Inc.","started":"2018-12-15","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06881784","kind":"trial","name":"Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)","aka":["RASolve 301"],"tldr":"A phase 3 trial of Daraxonrasib, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by Revolution Medicines, Inc., now recruiting.","summary":"Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) is a phase 3 interventional study registered as NCT06881784 by Revolution Medicines, Inc., with 590 participants planned, started 2025-05-06 and due to reach its primary completion in 2027-12-01. Interventions recorded: daraxonrasib, docetaxel. Conditions listed: NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer, NSCLC, NSCLC (Non-small Cell Lung Carcinoma). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06881784","url":"https://clinicaltrials.gov/study/NCT06881784"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","kras-inhibitors"],"targets":[],"drugs":["daraxonrasib","docetaxel"],"companies":["revolution-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06881784","phase":"3","setting":"RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC","sponsor":"Revolution Medicines, Inc.","started":"2025-05-06","startedType":"actual","enrolled":590,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07252232","kind":"trial","name":"Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)","aka":["RASolute 304"],"tldr":"A phase 3 trial of Daraxonrasib in pancreatic ductal adenocarcinoma, run by Revolution Medicines, Inc., now recruiting.","summary":"Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) is a phase 3 interventional study registered as NCT07252232 by Revolution Medicines, Inc., with 500 participants planned, started 2025-12-15 and due to reach its primary completion in 2029-05-10. Interventions recorded: daraxonrasib. Conditions listed: Pancreatic Cancer, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma (PDAC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07252232","url":"https://clinicaltrials.gov/study/NCT07252232"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["daraxonrasib"],"companies":["revolution-medicines"],"institutions":[],"pathways":[],"terms":["pancreatic-trials-open-today"],"trials":["prodige-24","rasolute-302"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["RASolute 304 (registry, 24 September 2026): phase 3 of adjuvant daraxonrasib against observation after neoadjuvant and/or adjuvant chemotherapy in resected pancreatic ductal adenocarcinoma; 500 participants (estimated), recruiting, started 15 December 2025, primary completion May 2029, disease-free survival by investigator. UK sites (6): University Hospitals Birmingham (Queen Elizabeth), Beatson West of Scotland Cancer Centre Glasgow, Clatterbridge Liverpool, Royal Marsden London, Hammersmith (Imperial), the Christie Manchester."],"nct":"NCT07252232","phase":"3","setting":"RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2-Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)","sponsor":"Revolution Medicines, Inc.","started":"2025-12-15","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07491445","kind":"trial","name":"Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma","aka":["RASolute 303"],"tldr":"A phase 3 trial of Daraxonrasib, Gemcitabine, Paclitaxel / nab-paclitaxel in pancreatic ductal adenocarcinoma, run by Revolution Medicines, Inc., now recruiting.","summary":"Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma is a phase 3 interventional study registered as NCT07491445 by Revolution Medicines, Inc., with 900 participants planned, started 2026-03-09 and due to reach its primary completion in 2028-06. Interventions recorded: daraxonrasib, gemcitabine, nab-paclitaxel. Conditions listed: Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07491445","url":"https://clinicaltrials.gov/study/NCT07491445"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","kras-inhibitors"],"targets":[],"drugs":["daraxonrasib","gemcitabine","paclitaxel"],"companies":["revolution-medicines"],"institutions":[],"pathways":[],"terms":["pancreatic-trials-open-today"],"trials":["rasolute-302","mpact"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["RASolute 303 (registry, 24 September 2026): phase 3, three arms, daraxonrasib alone or with gemcitabine and nab-paclitaxel against gemcitabine and nab-paclitaxel as first-line treatment for metastatic pancreatic adenocarcinoma; 900 participants (estimated), recruiting, started 9 March 2026, primary completion June 2028; progression-free and overall survival primary endpoints. UK sites (6): Torbay Hospital, Queen Elizabeth Hospital Birmingham, Addenbrooke's Cambridge, Barts (London), Royal Marsden (London), the Christie (Manchester)."],"nct":"NCT07491445","phase":"3","setting":"RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma","sponsor":"Revolution Medicines, Inc.","started":"2026-03-09","startedType":"actual","enrolled":900,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05489211","kind":"trial","name":"Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)","aka":["TROPION-PanTumor03"],"tldr":"A phase 2 trial of Datopotamab deruxtecan, Capecitabine, Fluorouracil in endometrial cancer and prostate cancer, run by AstraZeneca, now recruiting.","summary":"Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) is a phase 2 interventional study registered as NCT05489211 by AstraZeneca, with 454 participants planned, started 2022-09-06 and due to reach its primary completion in 2027-10-01. Interventions recorded: Datopotamab deruxtecan (Dato-DXd), Capecitabine, 5-Fluorouracil, Volrustomig, Carboplatin. Conditions listed: Endometrial Cancer, Gastric Cancer, Metastatic Castration-resistant Prostate Cancer, Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05489211","url":"https://clinicaltrials.gov/study/NCT05489211"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial","prostate","ovarian","colorectal"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan","capecitabine","fluorouracil","carboplatin","bevacizumab","rilvegostomig"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05489211","phase":"2","setting":"A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours","sponsor":"AstraZeneca","started":"2022-09-06","startedType":"actual","enrolled":454,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05215340","kind":"trial","name":"Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionab","aka":["TROPION-Lung08"],"tldr":"A phase 3 trial of Datopotamab deruxtecan, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Daiichi Sankyo, active and no longer recruiting.","summary":"Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations is a phase 3 interventional study registered as NCT05215340 by Daiichi Sankyo, with 740 participants enrolled, started 2022-03-04 and due to reach its primary completion in 2030-03-04. Interventions recorded: Datopotamab Deruxtecan, Pembrolizumab. Conditions listed: Metastatic Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05215340","url":"https://clinicaltrials.gov/study/NCT05215340"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["datopotamab-deruxtecan","pembrolizumab"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05215340","phase":"3","setting":"A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)","sponsor":"Daiichi Sankyo","started":"2022-03-04","startedType":"actual","enrolled":740,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07129993","kind":"trial","name":"Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma","aka":[],"tldr":"A phase 2/3 trial of Carboplatin, Cisplatin and Gemcitabine in bladder & urothelial cancer, run by Daiichi Sankyo, now recruiting.","summary":"Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma is a phase 2/3 interventional study registered as NCT07129993 by Daiichi Sankyo, with 630 participants planned, started 2025-09-26 and due to reach its primary completion in 2029-06-01. Interventions recorded: Dato-DXd, Carboplatin, Cisplatin and Gemcitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07129993","url":"https://clinicaltrials.gov/study/NCT07129993"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","cisplatin","gemcitabine"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07129993","phase":"2/3","setting":"A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) Who Progressed During or After Enfortumab Vedotin (EV) Plus Pembrolizumab Combination Treatment TROPION-Urothelial03 (TU03)","sponsor":"Daiichi Sankyo","started":"2025-09-26","startedType":"actual","enrolled":630,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05651022","kind":"trial","name":"Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Tislelizumab in hepatocellular carcinoma and colorectal cancer, run by Indaptus Therapeutics, Inc, active and no longer recruiting.","summary":"Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05651022 by Indaptus Therapeutics, Inc, with 120 participants planned, started 2023-02-28 and due to reach its primary completion in 2027-06-30. Interventions recorded: Decoy20, Tislelizumab. Conditions listed: Solid Tumor, Adult, HCC - Hepatocellular Carcinoma, CRC (Colorectal Cancer), Pancreatic Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05651022","url":"https://clinicaltrials.gov/study/NCT05651022"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","colorectal","nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05651022","phase":"1/2","setting":"A Phase 1/2, Open-Label, Multi-Center, Dose Escalation and Expansion Study Evaluating the Safety, Tolerability and Clinical Activity of DECOY20 as Monotherapy and in Combination With Tislelizumab in Patients With Advanced Solid Tumors","sponsor":"Indaptus Therapeutics, Inc","started":"2023-02-28","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07527858","kind":"trial","name":"Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of Nivolumab, Bevacizumab in colorectal cancer, run by Gilead Sciences, now recruiting.","summary":"Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer is a phase 2 interventional study registered as NCT07527858 by Gilead Sciences, with 170 participants planned, started 2026-05-19 and due to reach its primary completion in 2028-12. Interventions recorded: Denikitug, Nivolumab, Bevacizumab, Trifluridine-Tipiracil. Conditions listed: Advanced Microsatellite Stable Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07527858","url":"https://clinicaltrials.gov/study/NCT07527858"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","bevacizumab"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07527858","phase":"2","setting":"A Phase 2, Open Label, Multicenter, Randomized Study, to Evaluate the Efficacy and Safety of Denikitug Monotherapy and Denikitug-based Combinations in Participants With Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC)","sponsor":"Gilead Sciences","started":"2026-05-19","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01127451","kind":"trial","name":"Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma","aka":[],"tldr":"A phase 2 trial of Denileukin diftitox in Melanoma and Advanced melanoma, run by Eisai Inc., completed.","summary":"Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma is a phase 2 interventional study registered as NCT01127451 by Eisai Inc., with 75 participants recorded, started 2010-06-22 and reaching its primary completion in 2015-04-07. Interventions recorded: Denileukin diftitox. Conditions recorded: Stage IIIC Melanoma, Stage IV Melanoma.\n\nLinked to the drug Denileukin diftitox because the registry names it among its interventions and Melanoma and Advanced melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01127451","url":"https://clinicaltrials.gov/study/NCT01127451"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["denileukin-diftitox"],"companies":["eisai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01127451","phase":"2","setting":"A Phase II Open-Label, Multicenter Study of Denileukin Diftitox in Patients With Stage IIIC and Stage IV Melanoma","sponsor":"Eisai Inc.","started":"2010-06-22","startedType":"actual","yearReported":2022,"enrolled":75,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Immune-related Overall Response Rate (irORR)","primary":true,"unit":"%","arms":[{"name":"Denileukin Diftitox on Days 1 to 4","n":42,"value":9.5,"note":"90% CI 3.3 to 20.4; Figures from the ClinicalTrials.gov results section (first posted 2022-04-13), not from a publication"},{"name":"Denileukin Diftitox on Days 1, 8, and 15","n":32,"value":3.1,"note":"90% CI 0.1 to 13.9"}],"source":"https://clinicaltrials.gov/study/NCT01127451?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"weeks","arms":[{"name":"Denileukin Diftitox on Days 1 to 4","n":42,"value":51.1,"note":"90% CI 37.1 to 113.6; Figures from the ClinicalTrials.gov results section (first posted 2022-04-13), not from a publication"},{"name":"Denileukin Diftitox on Days 1, 8, and 15","n":32,"value":54.3,"note":"90% CI 30.7 to 77.1"}],"source":"https://clinicaltrials.gov/study/NCT01127451?tab=results"},{"endpoint":"Progression Free Survival (PFS)","unit":"weeks","arms":[{"name":"Denileukin Diftitox on Days 1 to 4","n":42,"value":12.1,"note":"90% CI 11.6 to 14.0; Figures from the ClinicalTrials.gov results section (first posted 2022-04-13), not from a publication"},{"name":"Denileukin Diftitox on Days 1, 8, and 15","n":32,"value":12.1,"note":"90% CI 11.6 to 13.0"}],"source":"https://clinicaltrials.gov/study/NCT01127451?tab=results"}]},{"id":"nct05320198","kind":"trial","name":"Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia","aka":["RALLY-MF"],"tldr":"A phase 1/2 trial of DISC-0974 in myeloproliferative neoplasms and myelodysplastic syndromes / neoplasms, run by Disc Medicine, Inc, now recruiting.","summary":"Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia is a phase 1/2 interventional study registered as NCT05320198 by Disc Medicine, Inc, with 150 participants planned, started 2022-06-06 and due to reach its primary completion in 2027-05. Interventions recorded: DISC-0974.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05320198","url":"https://clinicaltrials.gov/study/NCT05320198"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","mds","primary-myelofibrosis"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["disc-medicine"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05320198","phase":"1/2","setting":"RALLY-MF: A Phase 1b/2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of DISC-0974 in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia","sponsor":"Disc Medicine, Inc","started":"2022-06-06","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05880394","kind":"trial","name":"Study of Dotatate Imaging in Breast Cancer","aka":[],"tldr":"A phase 2 trial of Gallium-68 DOTATATE in Breast cancer, run by Hoag Memorial Hospital Presbyterian, with a status the registry has not verified recently.","summary":"Study of Dotatate Imaging in Breast Cancer is a phase 2 interventional study registered as NCT05880394 by Hoag Memorial Hospital Presbyterian, with 30 participants planned, started 2023-01-10 and due to reach its primary completion in 2024-07-31. Interventions recorded: Gallium-68 DOTATATE, Copper-64 DOTATATE. Conditions recorded: Breast Cancer Stage IV.\n\nLinked to the drug Gallium-68 DOTATATE because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05880394","url":"https://clinicaltrials.gov/study/NCT05880394"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ga68-dotatate"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05880394","phase":"2","setting":"Somatostatin Receptor Imaging Study of Estrogen Receptor Positive (ER+) Metastatic Breast Cancer","sponsor":"Hoag Memorial Hospital Presbyterian","started":"2023-01-10","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06819735","kind":"trial","name":"Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors","aka":["DOMISOL"],"tldr":"A phase 1/2 trial of DT-7012 in advanced solid tumours, run by Domain Therapeutics Australia Pty Ltd, now recruiting.","summary":"Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06819735 by Domain Therapeutics Australia Pty Ltd, with 125 participants planned, started 2025-06-25 and due to reach its primary completion in 2027-09. Interventions recorded: DT-7012 and Immune checkpoint inhibitor.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06819735","url":"https://clinicaltrials.gov/study/NCT06819735"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06819735","phase":"1/2","setting":"A Phase 1/2, Multicentre, Open-label Clinical Trial of DT-7012 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Participants With Selected Advanced Solid Tumors (DOMISOL, DOmain_therapeutics Monoclonal antIbody for SOLid Tumors)","sponsor":"Domain Therapeutics Australia Pty Ltd","started":"2025-06-25","startedType":"actual","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03164616","kind":"trial","name":"Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).","aka":["POSEIDON"],"tldr":"A phase 3 trial of Durvalumab, Tremelimumab, Paclitaxel / nab-paclitaxel in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON). is a phase 3 interventional study registered as NCT03164616 by AstraZeneca, with 1186 participants enrolled, started 2017-06-01 and due to reach its primary completion in 2021-03-12. Interventions recorded: Durvalumab, Tremelimumab, Abraxane + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin. Conditions listed: Non Small Cell Lung Cancer NSCLC. Results were posted on ClinicalTrials.gov in 2022; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03164616","url":"https://clinicaltrials.gov/study/NCT03164616"},{"label":"POSEIDON (Journal of Clinical Oncology 2023)","url":"https://doi.org/10.1200/JCO.22.00975"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab","paclitaxel","carboplatin","gemcitabine","cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":["checkmate-9la","checkmate-227","nct02453282","nct02542293"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["POSEIDON randomised 1,013 patients with EGFR and ALK wild-type metastatic non-small-cell lung cancer 1:1:1 to tremelimumab 75 mg with durvalumab 1,500 mg and platinum chemotherapy for up to four 21-day cycles then durvalumab every four weeks with one further tremelimumab dose; to durvalumab with chemotherapy then durvalumab; or to chemotherapy alone for up to six cycles. Progression-free survival for durvalumab with chemotherapy against chemotherapy was 5.5 against 4.8 months (hazard ratio 0.74, 95 percent confidence interval 0.62 to 0.89, p=0.0009) and overall survival 13.3 against 11.7 months (0.86, 0.72 to 1.02, p=0.0758, not significant). Adding tremelimumab gave progression-free survival 6.2 against 4.8 months (0.72, 0.60 to 0.86, p=0.0003) and overall survival 14.0 against 11.7 months (0.77, 0.65 to 0.92, p=0.0030), with 24-month overall survival 32.9 against 22.1 percent. Maximum grade 3 or 4 treatment-related events occurred in 51.8, 44.6 and 44.4 percent respectively (Journal of Clinical Oncology 2023). There is no NICE recommendation for either POSEIDON regimen."],"nct":"NCT03164616","phase":"3","setting":"A Phase III, Randomized, Multi-Center, Open-Label, Comparative Global Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Patients With Metastatic Non Small-Cell Lung Cancer (NSCLC) (POSEIDON)","sponsor":"AstraZeneca","result":"Durvalumab with chemotherapy improved progression-free survival (5.5 against 4.8 months, hazard ratio 0.74, p=0.0009) but not significantly overall survival; adding a limited course of tremelimumab improved both (overall survival 14.0 against 11.7 months, hazard ratio 0.77, p=0.0030).","started":"2017-06-01","startedType":"actual","yearReported":2022,"enrolled":1186,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Free Survival (PFS); D + SoC Compared With SoC Alone","primary":true,"unit":"months","arms":[{"name":"D + SoC","n":338,"value":5.5,"note":"95% CI 4.7 to 6.5; Figures from the ClinicalTrials.gov results section (first posted 2022-04-07), not from a publication"},{"name":"SoC Alone","n":337,"value":4.8,"note":"95% CI 4.6 to 5.8"}],"hr":0.74,"ci":[0.62,0.885],"p":"0.00093","source":"https://clinicaltrials.gov/study/NCT03164616?tab=results"},{"endpoint":"Overall Survival (OS); D + SoC Compared With SoC Alone","primary":true,"unit":"months","arms":[{"name":"D + SoC","n":338,"value":13.3,"note":"95% CI 11.4 to 14.7; Figures from the ClinicalTrials.gov results section (first posted 2022-04-07), not from a publication"},{"name":"SoC Alone","n":337,"value":11.7,"note":"95% CI 10.5 to 13.1"}],"hr":0.86,"ci":[0.724,1.016],"p":"0.07581","source":"https://clinicaltrials.gov/study/NCT03164616?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"T + D + SoC","n":335,"value":46.3,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-04-07), not from a publication"},{"name":"D + SoC","n":330,"value":48.5},{"name":"SoC Alone","n":332,"value":33.4}],"source":"https://clinicaltrials.gov/study/NCT03164616?tab=results"}]},{"id":"nct03003962","kind":"trial","name":"Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)","aka":["PEARL"],"tldr":"A phase 3 trial of Durvalumab, Carboplatin, Gemcitabine + cisplatin, Gemcitabine, Cisplatin and Pemetrexed in non-small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL) is a phase 3 interventional study registered as NCT03003962 by AstraZeneca, with 669 participants enrolled, started 2017-01-02 and due to reach its primary completion in 2022-10-27. Interventions recorded: Durvalumab (MEDI4736), Paclitaxel + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin, Pemetrexed + cisplatin and Pemetrexed + carboplatin. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03003962","url":"https://clinicaltrials.gov/study/NCT03003962"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","carboplatin","gemcitabine-cisplatin","gemcitabine","cisplatin","pemetrexed"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03003962-j-thorac-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03003962","phase":"3","setting":"A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients With PD-L1-High Expression Advanced Non Small-Cell Lung Cancer","sponsor":"AstraZeneca","started":"2017-01-02","startedType":"actual","yearReported":2023,"enrolled":669,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Durvalumab","n":335,"value":14.6,"note":"95% CI 12.2 to 16.9; Figures from the ClinicalTrials.gov results section (first posted 2023-12-26), not from a publication"},{"name":"Platinum-based SoC","n":334,"value":12.8,"note":"95% CI 10.1 to 14.7"}],"hr":0.84,"ci":[0.706,0.989],"p":"0.037","source":"https://clinicaltrials.gov/study/NCT03003962?tab=results"},{"endpoint":"OS in Participants With LREM","primary":true,"unit":"months","arms":[{"name":"Durvalumab","n":278,"value":14.6,"note":"95% CI 12.6 to 17.2; Figures from the ClinicalTrials.gov results section (first posted 2023-12-26), not from a publication"},{"name":"Platinum-based SoC","n":271,"value":15,"note":"95% CI 13.1 to 16.8"}],"hr":0.96,"ci":[0.793,1.151],"p":"0.628","source":"https://clinicaltrials.gov/study/NCT03003962?tab=results"},{"endpoint":"Objective Response Rate (ORR) as Per RECIST 1.1 Using Investigator Assessment","unit":"%","arms":[{"name":"Durvalumab","n":335,"value":37.6,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-12-26), not from a publication"},{"name":"Platinum-based SoC","n":334,"value":37.4}],"source":"https://clinicaltrials.gov/study/NCT03003962?tab=results"}]},{"id":"nct03682068","kind":"trial","name":"Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer","aka":["NILE"],"tldr":"A phase 3 trial of Durvalumab, Tremelimumab, Cisplatin, Gemcitabine and Carboplatin in bladder & urothelial cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer is a phase 3 interventional study registered as NCT03682068 by AstraZeneca, with 1246 participants enrolled, started 2018-09-27 and due to reach its primary completion in 2026-06-01. Interventions recorded: Durvalumab, Tremelimumab, Cisplatin + Gemcitabine and Carboplatin + Gemcitabine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03682068","url":"https://clinicaltrials.gov/study/NCT03682068"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab","cisplatin","gemcitabine","carboplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03682068","phase":"3","setting":"A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer.","sponsor":"AstraZeneca","started":"2018-09-27","startedType":"actual","enrolled":1246,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04550260","kind":"trial","name":"Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC","aka":["KUNLUN"],"tldr":"A phase 3 trial of Durvalumab, Cisplatin and Capecitabine in oesophageal cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC is a phase 3 interventional study registered as NCT04550260 by AstraZeneca, with 640 participants enrolled, started 2020-10-19 and due to reach its primary completion in 2027-06-30. Interventions recorded: Durvalumab, Placebo, cisplatin + fluorouracil, cisplatin + capecitabine and Radiation.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04550260","url":"https://clinicaltrials.gov/study/NCT04550260"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal","oesophageal-squamous-cell-carcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","cisplatin","capecitabine"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04550260","phase":"3","setting":"A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN)","sponsor":"AstraZeneca","started":"2020-10-19","startedType":"actual","enrolled":640,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02542293","kind":"trial","name":"Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)","aka":["NEPTUNE"],"tldr":"A phase 3 trial of Durvalumab, Tremelimumab, Carboplatin, Gemcitabine + cisplatin, Gemcitabine and Cisplatin in non-small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE) is a phase 3 interventional study registered as NCT02542293 by AstraZeneca, with 953 participants enrolled, started 2015-11-03 and due to reach its primary completion in 2020-09-21. Interventions recorded: Durvalumab +Tremelimumab, Paclitaxel + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin, Pemetrexed + cisplatin and Pemetrexed + carboplatin. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02542293","url":"https://clinicaltrials.gov/study/NCT02542293"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab","carboplatin","gemcitabine-cisplatin","gemcitabine","cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02542293","phase":"3","setting":"A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy Versus Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC).","sponsor":"AstraZeneca","started":"2015-11-03","startedType":"actual","yearReported":2022,"enrolled":953,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set","primary":true,"unit":"months","arms":[{"name":"Global: Durvalumab + Tremelimumab","n":69,"value":11.7,"note":"95% CI 8.6 to 15.2; Figures from the ClinicalTrials.gov results section (first posted 2022-05-24), not from a publication"},{"name":"Global: SoC Chemotherapy","n":60,"value":9.1,"note":"95% CI 7.8 to 12.6"}],"hr":0.71,"ci":[0.485,1.045],"p":"0.0808","source":"https://clinicaltrials.gov/study/NCT02542293?tab=results"},{"endpoint":"OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set","primary":true,"unit":"months","arms":[{"name":"China: Durvalumab + Tremelimumab","n":26,"value":15,"note":"95% CI 10.5 to 27.4; Figures from the ClinicalTrials.gov results section (first posted 2022-05-24), not from a publication"},{"name":"China: SoC Chemotherapy","n":29,"value":11.7,"note":"95% CI 8.6 to 20.5"}],"hr":0.6,"ci":[0.322,1.109],"source":"https://clinicaltrials.gov/study/NCT02542293?tab=results"}]},{"id":"nct03775486","kind":"trial","name":"Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)","aka":["ORION"],"tldr":"A phase 2 trial of Durvalumab, Olaparib, Paclitaxel / nab-paclitaxel in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION) is a phase 2 interventional study registered as NCT03775486 by AstraZeneca, with 401 participants enrolled, started 2018-12-21 and due to reach its primary completion in 2021-01-11. Interventions recorded: Durvalumab, Placebo for Olaparib, Olaparib, Nab-paclitaxel+carboplatin, Gemcitabine+carboplatin. Conditions listed: Non-small Cell Lung Cancer NSCLC. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03775486","url":"https://clinicaltrials.gov/study/NCT03775486"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["durvalumab","olaparib","paclitaxel","carboplatin","gemcitabine","pemetrexed"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03775486-j-thorac-oncol-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03775486","phase":"2","setting":"A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab Plus Olaparib Combination Therapy Compared With Durvalumab Monotherapy as Maintenance Therapy in Patients Whose Disease Has Not Progressed Following Standard of Care Platinum-Based Chemotherapy With Durvalumab in First Line Stage IV Non Small Cell Lung Cancer (ORION)","sponsor":"AstraZeneca","started":"2018-12-21","startedType":"actual","enrolled":401,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06726148","kind":"trial","name":"Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Ribociclib, Fulvestrant in small-cell lung cancer, run by Novartis Pharmaceuticals, now recruiting.","summary":"Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06726148 by Novartis Pharmaceuticals, with 280 participants planned, started 2025-04-03 and due to reach its primary completion in 2028-09-25. Interventions recorded: ECI830, ribociclib, fulvestrant. Conditions listed: Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Extensive-stage Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06726148","url":"https://clinicaltrials.gov/study/NCT06726148"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["ribociclib","fulvestrant"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06726148","phase":"1/2","setting":"An Open-label, Multi-center, Phase I/II Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors","sponsor":"Novartis Pharmaceuticals","started":"2025-04-03","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04836507","kind":"trial","name":"Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia Patients","aka":[],"tldr":"A phase 1/2 trial of CRC01, Fludarabine, Cyclophosphamide in diffuse large b-cell lymphoma and follicular lymphoma, run by Curocell Inc., now recruiting.","summary":"Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia Patients is a phase 1/2 interventional study registered as NCT04836507 by Curocell Inc., with 91 participants planned, started 2021-03-02 and due to reach its primary completion in 2030-08-15. Interventions recorded: CRC01, Fludarabine, Cyclophosphamide. Conditions listed: Relapsed Large B-cell Lymphoma, Refractory Large B-cell Lymphoma, Diffuse Large B-cell Lymphoma (DLBCL), Primary Mediastinal Large B-Cell Lymphoma (PMBCL). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04836507","url":"https://clinicaltrials.gov/study/NCT04836507"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl","follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["crc01","fludarabine","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04836507","phase":"1/2","setting":"An Open-label, Multi-center, Single-arm Phase 1/2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Adult Patients With Relapsed or Refractory Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia","sponsor":"Curocell Inc.","started":"2021-03-02","startedType":"actual","enrolled":91,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04940052","kind":"trial","name":"Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refracto","aka":[],"tldr":"A phase 3 trial of Dabrafenib, Trametinib in thyroid cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer is a phase 3 interventional study registered as NCT04940052 by Novartis Pharmaceuticals, with 153 participants enrolled, started 2021-11-15 and due to reach its primary completion in 2025-01-22. Interventions recorded: Dabrafenib, Trametinib, Trametinib Placebo, Dabrafenib placebo. Conditions listed: Differentiated Thyroid Cancer (DTC). Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04940052","url":"https://clinicaltrials.gov/study/NCT04940052"}],"tags":["ctgov-ingest"],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["dabrafenib","trametinib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04940052","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer (DTC)","sponsor":"Novartis Pharmaceuticals","started":"2021-11-15","startedType":"actual","yearReported":2026,"enrolled":153,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Dabrafenib Plus Trametinib","n":101,"value":12.8,"note":"95% CI 10.2 to 21.2; Figures from the ClinicalTrials.gov results section (first posted 2026-05-22), not from a publication"},{"name":"Dabrafenib Placebo Plus Trametinib Placebo","n":52,"value":3.7,"note":"95% CI 2.3 to 7.5"}],"hr":0.38,"ci":[0.25,0.57],"p":"<0.001","source":"https://clinicaltrials.gov/study/NCT04940052?tab=results"},{"endpoint":"Overall Response Rate (ORR)","unit":"%","arms":[{"name":"Dabrafenib Plus Trametinib","n":101,"value":57.4,"note":"95% CI 47.2 to 67.2; Figures from the ClinicalTrials.gov results section (first posted 2026-05-22), not from a publication"},{"name":"Dabrafenib Placebo Plus Trametinib Placebo","n":52,"value":3.8,"note":"95% CI 0.5 to 13.2"}],"p":"<0.001","source":"https://clinicaltrials.gov/study/NCT04940052?tab=results"}]},{"id":"nct04375683","kind":"trial","name":"Study of Efficacy and Safety of Flumatinib Combined With Chemotherapy in Ph Positive ALL","aka":[],"tldr":"A phase 3 trial of Flumatinib in Leukaemia, run by Zhongda Hospital, with a status the registry has not verified recently.","summary":"Study of Efficacy and Safety of Flumatinib Combined With Chemotherapy in Ph Positive ALL is a phase 3 interventional study registered as NCT04375683 by Zhongda Hospital, with 28 participants planned, started 2020-03-01 and due to reach its primary completion in 2022-12-30. Interventions recorded: Flumatinib. Conditions recorded: Acute Lymphocytic Leukemia, Adult B-Cell, BCR-ABL1 Fusion Protein Expression.\n\nLinked to the drug Flumatinib because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04375683","url":"https://clinicaltrials.gov/study/NCT04375683"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["flumatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04375683","phase":"3","setting":"A Study of Efficacy and Safety of Flumatinib Combined With Chemotherapy in the Treatment of Ph Positive Acute Lymphoblastic Leukemia Based on Minimal Residual Disease Monitoring","sponsor":"Zhongda Hospital","started":"2020-03-01","startedType":"actual","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05445843","kind":"trial","name":"Study of Efficacy and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C- Mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.","aka":["KontRASt-06"],"tldr":"A phase 2 trial of JDQ443 in non-small-cell lung cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study of Efficacy and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C- Mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation. is a phase 2 interventional study registered as NCT05445843 by Novartis Pharmaceuticals, with 95 participants enrolled, started 2022-12-06 and due to reach its primary completion in 2024-11-04. Interventions recorded: JDQ443. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05445843","url":"https://clinicaltrials.gov/study/NCT05445843"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["jdq443"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05445843","phase":"2","setting":"KontRASt-06: An Open-label Phase II Trial Evaluating the Activity and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.","sponsor":"Novartis Pharmaceuticals","started":"2022-12-06","startedType":"actual","yearReported":2025,"enrolled":95,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Response Rate (ORR) as Determined by the Investigator in Cohort A","primary":true,"unit":"%","arms":[{"name":"Cohort A- PD-L1<1%","n":72,"value":29.2,"note":"95% CI 19.0 to 41.1; Figures from the ClinicalTrials.gov results section (first posted 2025-10-09), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT05445843?tab=results"}]},{"id":"nct04417621","kind":"trial","name":"Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma","aka":[],"tldr":"A phase 2 trial of Naporafenib, Trametinib, Ribociclib in melanoma, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma is a phase 2 interventional study registered as NCT04417621 by Novartis Pharmaceuticals, with 134 participants enrolled, started 2020-10-30 and due to reach its primary completion in 2027-02-02. Interventions recorded: LXH254, LTT462, Trametinib, Ribociclib. Conditions listed: Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04417621","url":"https://clinicaltrials.gov/study/NCT04417621"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["naporafenib","trametinib","ribociclib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04417621","phase":"2","setting":"A Randomized, Open-label, Multi-arm, Two-part, Phase II Study to Assess Efficacy and Safety of Multiple LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic BRAFV600 or NRAS Mutant Melanoma","sponsor":"Novartis Pharmaceuticals","started":"2020-10-30","startedType":"actual","enrolled":134,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03876769","kind":"trial","name":"Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients","aka":[],"tldr":"A phase 2 trial of Tisagenlecleucel in acute lymphoblastic leukaemia, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients is a phase 2 interventional study registered as NCT03876769 by Novartis Pharmaceuticals, with 121 participants enrolled, started 2019-06-24 and due to reach its primary completion in 2027-10-19. Interventions recorded: CTL019.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03876769","url":"https://clinicaltrials.gov/study/NCT03876769"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","all-paediatric-high-risk"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["tisagenlecleucel"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03876769","phase":"2","setting":"A Phase II Trial of Tisagenlecleucel in First-line High-risk (HR) Pediatric and Young Adult Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL) Who Are Minimal Residual Disease (MRD) Positive at the End of Consolidation (EOC) Therapy","sponsor":"Novartis Pharmaceuticals","started":"2019-06-24","startedType":"actual","enrolled":121,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06726265","kind":"trial","name":"Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy ","aka":["TACTI-004"],"tldr":"A phase 3 trial of Pemetrexed, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Immutep S.A.S., active and no longer recruiting.","summary":"Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004) is a phase 3 interventional study registered as NCT06726265 by Immutep S.A.S., with 756 participants planned, started 2025-03-21 and due to reach its primary completion in 2027-06. Interventions recorded: eftilagimod alfa, carboplatin plus paclitaxel, cisplatin or carboplatin + pemetrexed, pembrolizumab (KEYTRUDA®), Placebo. Conditions listed: Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06726265","url":"https://clinicaltrials.gov/study/NCT06726265"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pemetrexed","pembrolizumab"],"companies":["immutep"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06726265","phase":"3","setting":"TACTI-004, a Double-Blinded, Randomized Phase 3 Trial in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Receiving Eftilagimod Alfa (MHC Class II Agonist) in Combination With Pembrolizumab (PD-1 Antagonist) and Chemotherapy.","sponsor":"Immutep S.A.S.","started":"2025-03-21","startedType":"actual","enrolled":756,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06479239","kind":"trial","name":"Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer","aka":["Panc 002"],"tldr":"A phase 1/2 trial in pancreatic cancer, run by University of Virginia, now recruiting.","summary":"Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer is a phase 1/2, interventional study registered as NCT06479239 by University of Virginia, with a registry enrolment figure of 23 participants, started 2024-11-06 and due to reach its primary completion in 2027-12. Interventions recorded: EGFR FPBMC. Conditions listed: Pancreas Cancer; Pancreatic Cancer. Primary outcome: Dose limiting toxicities (DLTs) during the dose escalation phase (during the first 8 infusions only). Pancreatic eligibility wording from the registry: \"Histologically confirmed locally advanced pancreatic cancer (LAPC)/unresectable pancreatic cancer (UPC) or metastatic pancreatic cancer (MPC) not eligible for curative intent therapy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06479239","url":"https://clinicaltrials.gov/study/NCT06479239"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06479239","phase":"1/2","setting":"Phase I/II Study of Anti-CD3 x Anti-EGFR Bispecific Antibody (EGFRBi) Armed Fresh Peripheral Blood Mononuclear Cells (EGFR FPBMC) in Metastatic or Unresectable Pancreatic Cancer","sponsor":"University of Virginia","started":"2024-11-06","startedType":"actual","enrolled":23,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06128551","kind":"trial","name":"Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Elironrasib, Daraxonrasib in non-small-cell lung cancer and small-cell lung cancer, run by Revolution Medicines, Inc., now recruiting.","summary":"Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors is a phase 1/2 interventional study registered as NCT06128551 by Revolution Medicines, Inc., with 534 participants planned, started 2023-11-14 and due to reach its primary completion in 2028-12. Interventions recorded: Elironrasib, Daraxonrasib. Conditions listed: Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer, Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06128551","url":"https://clinicaltrials.gov/study/NCT06128551"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","colorectal","pancreatic","kras-g12c-pdac","kras-g12c-colorectal","kras-g12c-nsclc"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["elironrasib","daraxonrasib"],"companies":["revolution-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06128551","phase":"1/2","setting":"Phase 1b/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients With Advanced KRAS G12C-Mutated Solid Tumors","sponsor":"Revolution Medicines, Inc.","started":"2023-11-14","startedType":"actual","enrolled":534,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05417789","kind":"trial","name":"Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)","aka":["TANGENT"],"tldr":"A phase 3 trial testing Emactuzumab in tenosynovial giant cell tumour, active and no longer recruiting.","summary":"Study of Emactuzumab for Tenosynovial Giant Cell Tumour (TGCT) is a phase 3 interventional study registered as NCT05417789, led by SynOx Therapeutics, and active but no longer recruiting on the registry. Official title: A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy of Emactuzumab vs. Placebo in Subjects With Tenosynovial Giant Cell Tumour. Planned enrolment is 128 participants (estimated). The study started in 2024-10-09 and primary completion is expected in 2025-12-23. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05417789","url":"https://clinicaltrials.gov/study/NCT05417789"}],"tags":["ctgov-ingest"],"related":[],"cancers":["tenosynovial-giant-cell-tumour"],"sections":[],"technologies":[],"targets":[],"drugs":["emactuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05417789","phase":"3","setting":"A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy of Emactuzumab vs. Placebo in Subjects With Tenosynovial Giant Cell Tumour","sponsor":"SynOx Therapeutics","started":"2024-10-09","startedType":"actual","enrolled":128,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02650401","kind":"trial","name":"Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options","aka":["STARTRK-NG"],"tldr":"A phase 1/2 trial of Entrectinib in brain and spinal cord tumours, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options is a phase 1/2 interventional study registered as NCT02650401 by Hoffmann-La Roche, with 69 participants enrolled, started 2016-05-03 and due to reach its primary completion in 2026-06-30. Interventions recorded: Entrectinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02650401","url":"https://clinicaltrials.gov/study/NCT02650401"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["brain-tumours"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["entrectinib"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02650401","phase":"1/2","setting":"A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib (Rxdx-101) In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options","sponsor":"Hoffmann-La Roche","started":"2016-05-03","startedType":"actual","enrolled":69,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05112991","kind":"trial","name":"Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer","aka":[],"tldr":"A phase 2 trial of Envafolimab, Lenvatinib in endometrial cancer, run by 3D Medicines (Sichuan) Co., Ltd., now recruiting.","summary":"Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer is a phase 2 interventional study registered as NCT05112991 by 3D Medicines (Sichuan) Co., Ltd., with 108 participants planned, started 2022-03-04 and due to reach its primary completion in 2026-12. Interventions recorded: Envafolimab+Lenvatinib, Envafolimab. Conditions listed: Advanced Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05112991","url":"https://clinicaltrials.gov/study/NCT05112991"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["envafolimab","lenvatinib"],"companies":["3d-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05112991","phase":"2","setting":"An Open-label, Multi-center, Multi-corhort Phase II Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer","sponsor":"3D Medicines (Sichuan) Co., Ltd.","started":"2022-03-04","startedType":"actual","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05316155","kind":"trial","name":"Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer","aka":[],"tldr":"A phase 1/2 trial of Erdafitinib in bladder & urothelial cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer is a phase 1/2 interventional study registered as NCT05316155 by Janssen Research & Development, LLC, with 235 participants enrolled, started 2022-04-11 and due to reach its primary completion in 2028-03-30. Interventions recorded: Erdafitinib Intravesical Delivery System.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05316155","url":"https://clinicaltrials.gov/study/NCT05316155"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["erdafitinib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05316155","phase":"1/2","setting":"Phase 1/2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer","sponsor":"Janssen Research & Development, LLC","started":"2022-04-11","startedType":"actual","enrolled":235,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06567015","kind":"trial","name":"Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs","aka":[],"tldr":"A phase 1/2 trial of STX-241 in non-small-cell lung cancer, run by Pierre Fabre Medicament, now recruiting.","summary":"Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs is a phase 1/2 interventional study registered as NCT06567015 by Pierre Fabre Medicament, with 171 participants planned, started 2024-09-17 and due to reach its primary completion in 2027-11-20. Interventions recorded: STX-241.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06567015","url":"https://clinicaltrials.gov/study/NCT06567015"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":["egfr"],"drugs":[],"companies":["pierre-fabre"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06567015","phase":"1/2","setting":"Phase I/II First-In-Human Open-label Trial to Assess Safety and Efficacy of STX-241 in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Resistant to EGFR Tyrosine Kinase Inhibitors (TKIs).","sponsor":"Pierre Fabre Medicament","started":"2024-09-17","startedType":"actual","enrolled":171,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03874026","kind":"trial","name":"Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients","aka":["CIFRA"],"tldr":"A phase 2 trial in colorectal cancer, run by National Cancer Institute, Naples, now recruiting.","summary":"Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients is a phase 2, interventional study registered as NCT03874026 by National Cancer Institute, Naples, with a registry enrolment figure of 34 participants, started 2019-09-05 and due to reach its primary completion in 2023-05-19. Interventions recorded: Folfiri/Cetuximab. Conditions listed: Colorectal Cancer; ADCC. Primary outcome: Activity. Colorectal eligibility wording from the registry: \"* Cytological or histological diagnosis of colorectal adenocarcinoma;\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03874026","url":"https://clinicaltrials.gov/study/NCT03874026"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03874026","phase":"2","setting":"Cetuximab, Irinotecan and Fluorouracile in FiRst-line Treatment of Immunologically-selected Advanced Colorectal Cancer Patients: the CIFRA Study","sponsor":"National Cancer Institute, Naples","started":"2019-09-05","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06255379","kind":"trial","name":"Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Guangzhou University of Traditional Chinese Medicine, not yet recruiting.","summary":"Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06255379 by Guangzhou University of Traditional Chinese Medicine, with a registry enrolment figure of 52 participants, started 2024-05-06 and due to reach its primary completion in 2027-03-21. Interventions recorded: Fuquinitinib+Tegafur Gimeracil Oteracil. Conditions listed: Metastasis Colorectal Cancer; Colon Cancer; Rectal Cancer. Primary outcome: Progression Free Survival (PFS). Colorectal eligibility wording from the registry: \"Histologically and/or cytologically documented metastatic colorectal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06255379","url":"https://clinicaltrials.gov/study/NCT06255379"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06255379","phase":"2","setting":"An Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC","sponsor":"Guangzhou University of Traditional Chinese Medicine","started":"2024-05-06","startedType":"estimated","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06584032","kind":"trial","name":"Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer","aka":[],"tldr":"A phase 3 trial of Fruquintinib, Sintilimab, Paclitaxel / nab-paclitaxel in endometrial cancer, run by Hutchmed, now recruiting.","summary":"Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer is a phase 3 interventional study registered as NCT06584032 by Hutchmed, with 412 participants planned, started 2024-12-12 and due to reach its primary completion in 2029-01-08. Interventions recorded: fruquintinib, sintilimab, paclitaxel, doxorubicin. Conditions listed: Advanced Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06584032","url":"https://clinicaltrials.gov/study/NCT06584032"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["fruquintinib","sintilimab","paclitaxel","doxorubicin"],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06584032","phase":"3","setting":"A Randomized,Open-label,Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Fruquintinib Plus Sintilimab Versus Chemotherapy of the Treating Physician's Choice as Second-line Treatment for Advanced Endometrial Cancer","sponsor":"Hutchmed","started":"2024-12-12","startedType":"actual","enrolled":412,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05727176","kind":"trial","name":"Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement","aka":["FOENIX-CCA4"],"tldr":"A phase 2 trial of TAS-120 in biliary tract cancer, run by Taiho Oncology, Inc., now recruiting.","summary":"Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement is a phase 2 interventional study registered as NCT05727176 by Taiho Oncology, Inc., with 120 participants planned, started 2023-07-05 and due to reach its primary completion in 2026-12. Interventions recorded: TAS-120.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05727176","url":"https://clinicaltrials.gov/study/NCT05727176"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["araris"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05727176","phase":"2","setting":"Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements","sponsor":"Taiho Oncology, Inc.","started":"2023-07-05","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01011231","kind":"trial","name":"Study of Gamma-Knife Radiosurgery Using Magnetic Resonance Imaging (MRI) Spectroscopy for Recurrent Glioma","aka":[],"tldr":"A phase 2 trial of Gamma Knife in Glioma & glioblastoma, run by University of California, San Francisco, recorded as terminated on the registry.","summary":"Study of Gamma-Knife Radiosurgery Using Magnetic Resonance Imaging (MRI) Spectroscopy for Recurrent Glioma is a phase 2 interventional study registered as NCT01011231 by University of California, San Francisco, with 1 participants recorded, started 2009-12 and due to reach its primary completion in 2011-04. Interventions recorded: Gamma Knife Radiosurgery. Conditions recorded: Glioblastoma.\n\nLinked to the technology Gamma Knife because the registry names it (\"gamma knife\") among its interventions and Glioma & glioblastoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01011231","url":"https://clinicaltrials.gov/study/NCT01011231"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["gamma-knife"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01011231","phase":"2","setting":"Phase II Study of Gamma-Knife Radiosurgery Using Magnetic Resonance Spectroscopy for Target Definition in Patients With Recurrent Glioma","sponsor":"University of California, San Francisco","started":"2009-12","enrolled":1,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06048133","kind":"trial","name":"Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)","aka":["QUIC"],"tldr":"A phase 2 trial of zimberelimab, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by Nataliya Uboha, active and no longer recruiting.","summary":"Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC) is a phase 2 interventional study registered as NCT06048133 by Nataliya Uboha, with a registry enrolment figure of 33 participants, started 2024-03-08 and due to reach its primary completion in 2026-12. Interventions recorded: Gemcitabine, Cisplatin, Zimberelimab, Quemliclustat. Conditions listed: Biliary Tract Carcinoma, Cholangiocarcinoma, Bile Duct Cancer. Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06048133","url":"https://clinicaltrials.gov/study/NCT06048133"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["zimberelimab","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06048133","phase":"2","setting":"Study of Gemcitabine, Cisplatin, Quemliclustat (AB680) and Zimberelimab (AB122) During First-line Treatment of Advanced Biliary Tract Cancers (QUIC)","sponsor":"Nataliya Uboha","started":"2024-03-08","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03301168","kind":"trial","name":"Study of Gene Modified Donor T-cells Following TCR Alpha Beta Positive Depleted Stem Cell Transplant","aka":[],"tldr":"A phase 1/2 trial of BPX-501 T cells in acute lymphoblastic leukaemia, acute myeloid leukaemia, non-Hodgkin lymphoma and myelodysplastic syndromes / neoplasms, run by Bellicum Pharmaceuticals, active and no longer recruiting.","summary":"Study of Gene Modified Donor T-cells Following TCR Alpha Beta Positive Depleted Stem Cell Transplant is a phase 1/2 interventional study registered as NCT03301168 by Bellicum Pharmaceuticals, with 120 participants enrolled, started 2014-04 and due to reach its primary completion in 2021-05-11. Interventions recorded: BPX-501 T cells and Rimiducid.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03301168","url":"https://clinicaltrials.gov/study/NCT03301168"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","aml","non-hodgkin-lymphoma","mds","aml-paediatric"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bellicum"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03301168","phase":"1/2","setting":"Phase I/II Study of CaspaCIDe® T Cells From an HLA-Partially Matched Family Donor After Negative Selection of TCR αβ+T Cells in Pediatric Patients Affected by Hematological Disorders","sponsor":"Bellicum Pharmaceuticals","started":"2014-04","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07070518","kind":"trial","name":"Study of GV20-0251 in Participants With Solid Tumor Malignancies","aka":[],"tldr":"A phase 1/2 trial of GV20-0251 in endometrial cancer, head and neck squamous cell carcinoma, non-small-cell lung cancer, melanoma, hepatocellular carcinoma and small-cell lung cancer, run by GV20 Therapeutics, now recruiting.","summary":"Study of GV20-0251 in Participants With Solid Tumor Malignancies is a phase 1/2 interventional study registered as NCT07070518 by GV20 Therapeutics, with 350 participants planned, started 2025-07-11 and due to reach its primary completion in 2027-07-16. Interventions recorded: GV20-0251.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07070518","url":"https://clinicaltrials.gov/study/NCT07070518"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial","head-and-neck","nsclc","melanoma","hcc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["gv20-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07070518","phase":"1/2","setting":"An Open-Label Phase 1/2A Study of GV20-0251 in Participants With Advanced and/or Refractory Solid Tumor Malignancies","sponsor":"GV20 Therapeutics","started":"2025-07-11","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07288359","kind":"trial","name":"Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Fulvestrant, Letrozole in prostate cancer, run by Novartis Pharmaceuticals, now recruiting.","summary":"Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07288359 by Novartis Pharmaceuticals, with 205 participants planned, started 2025-12-29 and due to reach its primary completion in 2031-05-09. Interventions recorded: GVV858, Fulvestrant, Letrozole. Conditions listed: Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07288359","url":"https://clinicaltrials.gov/study/NCT07288359"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["fulvestrant","letrozole"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07288359","phase":"1/2","setting":"An Open-label, Multi-center, Phase I/II Study of GVV858 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer and Other Advanced Solid Tumors","sponsor":"Novartis Pharmaceuticals","started":"2025-12-29","startedType":"actual","enrolled":205,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01394263","kind":"trial","name":"Study of Histrelin Subdermal Implant in Patients With Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Histrelin and Goserelin / leuprolide in Prostate cancer, run by Endo USA Inc., a Keenova Therapeutics Company, completed.","summary":"Study of Histrelin Subdermal Implant in Patients With Prostate Cancer is a phase 3 interventional study registered as NCT01394263 by Endo USA Inc., a Keenova Therapeutics Company, with 59 participants recorded, started 2000-05 and reaching its primary completion in 2001-12. Interventions recorded: Histrelin hydrogel implant, Zoladex goserelin implant. Conditions recorded: Prostate Cancer, Adenocarcinoma of the Prostate.\n\nLinked to the drug Histrelin because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01394263","url":"https://clinicaltrials.gov/study/NCT01394263"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["histrelin","goserelin"],"companies":["endo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01394263","phase":"3","setting":"Phase III, Open-Label Randomized, Parallel, Active-Control Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Metastatic Prostate Cancer","sponsor":"Endo USA Inc., a Keenova Therapeutics Company","started":"2000-05","enrolled":59,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06800313","kind":"trial","name":"Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer","aka":[],"tldr":"A phase 1/2 trial of JNJ-101556143 Formulation 1 in prostate cancer, run by Janssen Research & Development, LLC, now recruiting.","summary":"Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer is a phase 1/2 interventional study registered as NCT06800313 by Janssen Research & Development, LLC, with 190 participants planned, started 2025-02-06 and due to reach its primary completion in 2028-07-11. Interventions recorded: JNJ-101556143 Formulation 1, JNJ-101556143 Formulation 2 and JNJ-101556143 Formulation 3.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06800313","url":"https://clinicaltrials.gov/study/NCT06800313"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06800313","phase":"1/2","setting":"Phase 1/2 Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer","sponsor":"Janssen Research & Development, LLC","started":"2025-02-06","startedType":"actual","enrolled":190,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06601504","kind":"trial","name":"Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL","aka":[],"tldr":"A phase 2 trial of Rituximab, Gemcitabine in diffuse large b-cell lymphoma, run by Hutchmed, active and no longer recruiting.","summary":"Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL is a phase 2 interventional study registered as NCT06601504 by Hutchmed, with 61 participants enrolled, started 2024-11-05 and due to reach its primary completion in 2026-05-12. Interventions recorded: HMPL-760 planned dose 1, R-GemOx, HMPL-760 placebo planned dose 1, HMPL-760 planned dose 2, HMPL-760 placebo planned dose 2. Conditions listed: Relapsed/Refractory Diffuse Large B-Cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06601504","url":"https://clinicaltrials.gov/study/NCT06601504"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["rituximab","gemcitabine"],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06601504","phase":"2","setting":"A Phase II Randomized, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma(R/R DLBCL)","sponsor":"Hutchmed","started":"2024-11-05","startedType":"actual","enrolled":61,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06222879","kind":"trial","name":"Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of HRS-8080, Trastuzumab rezetecan, SHR-A2009 and Adebrelimab in advanced solid tumours, run by Shandong Suncadia Medicine Co., Ltd., now recruiting.","summary":"Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer is a phase 1/2 interventional study registered as NCT06222879 by Shandong Suncadia Medicine Co., Ltd., with 350 participants planned, started 2024-02-20 and due to reach its primary completion in 2026-10-31. Interventions recorded: HRS-8080; SHR-A1811, HRS-8080; SHR-A2009 and SHR-A2009; SHR-1316.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06222879","url":"https://clinicaltrials.gov/study/NCT06222879"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["hrs-8080","trastuzumab-rezetecan","shr-a2009","adebrelimab"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06222879","phase":"1/2","setting":"A Multi-center, Open-label Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer","sponsor":"Shandong Suncadia Medicine Co., Ltd.","started":"2024-02-20","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06935409","kind":"trial","name":"Study of HS-20093 Versus Gemcitabine in Combination With Docetaxel in Treatment of Osteosarcoma After Previous Second-line Treatment Failure","aka":["ARTEMIS-011"],"tldr":"A phase 3 trial testing HS-20093 in osteosarcoma, active and no longer recruiting.","summary":"Study of HS-20093 Versus Gemcitabine in Combination With Docetaxel in Treatment of Osteosarcoma After Previous Second-line Treatment Failure is a phase 3 interventional study registered as NCT06935409, led by Hansoh BioMedical R&D, and active but no longer recruiting on the registry. Official title: A Randomised, Controlled, Open-label, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of HS-20093 for Injection Versus Gemcitabine in Combination With Docetaxel in the Treatment of Osteosarcoma After Previous Second-line Treatment Failure (ARTEMIS-011). Planned enrolment is 117 participants (estimated). The study started in 2025-04-25 and primary completion is expected in 2026-08-31. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06935409","url":"https://clinicaltrials.gov/study/NCT06935409"}],"tags":["ctgov-ingest"],"related":[],"cancers":["osteosarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["hs-20093"],"companies":["hansoh-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06935409","phase":"3","setting":"A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of HS-20093 for Injection Versus Gemcitabine in Combination With Docetaxel in the Treatment of Osteosarcoma After Previous Second-line Treatment Failure (ARTEMIS-011)","sponsor":"Hansoh BioMedical R&D","started":"2025-04-25","startedType":"actual","enrolled":117,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06834672","kind":"trial","name":"Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","aka":[],"tldr":"A phase 3 trial testing IBI354 in ovarian cancer, active and no longer recruiting.","summary":"Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer is a phase 3 interventional study registered as NCT06834672, led by Innovent Biologics (Suzhou), and active but no longer recruiting on the registry. Official title: A Multicenter, Randomised, Open-label Phase III Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer. Planned enrolment is 450 participants (estimated). The study started in 2025-03-17 and primary completion is expected in 2027-12-28. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06834672","url":"https://clinicaltrials.gov/study/NCT06834672"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["ibi354"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06834672","phase":"3","setting":"A Multicenter, Randomized, Open-label Phase III Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","sponsor":"Innovent Biologics (Suzhou)","started":"2025-03-17","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05745623","kind":"trial","name":"Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors","aka":[],"tldr":"A phase 1/2 trial of ICP-723 in brain and spinal cord tumours, run by Beijing InnoCare Pharma Tech Co., Ltd., now recruiting.","summary":"Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors is a phase 1/2 interventional study registered as NCT05745623 by Beijing InnoCare Pharma Tech Co., Ltd., with 70 participants planned, started 2022-12-27 and due to reach its primary completion in 2027-12-25. Interventions recorded: ICP-723.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05745623","url":"https://clinicaltrials.gov/study/NCT05745623"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["brain-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["innocare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05745623","phase":"1/2","setting":"A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","started":"2022-12-27","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03947385","kind":"trial","name":"Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions","aka":[],"tldr":"A phase 1/2 trial of Darovasertib, Binimetinib, Crizotinib in melanoma and uveal melanoma, run by IDEAYA Biosciences, now recruiting.","summary":"Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions is a phase 1/2 interventional study registered as NCT03947385 by IDEAYA Biosciences, with 336 participants planned, started 2019-06-28 and due to reach its primary completion in 2027-01-29. Interventions recorded: IDE196, Binimetinib, Crizotinib. Conditions listed: Metastatic Uveal Melanoma, Cutaneous Melanoma, Colorectal Cancer, Other Solid Tumors. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03947385","url":"https://clinicaltrials.gov/study/NCT03947385"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","uveal-melanoma","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["darovasertib","binimetinib","crizotinib"],"companies":["ideaya-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03947385","phase":"1/2","setting":"A Phase 1/2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions","sponsor":"IDEAYA Biosciences","started":"2019-06-28","startedType":"actual","enrolled":336,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04145622","kind":"trial","name":"Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors","aka":["IDeate-PanTumor01"],"tldr":"A phase 1/2 trial of Ifinatamab deruxtecan in advanced solid tumours, run by Daiichi Sankyo, now recruiting.","summary":"Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors is a phase 1/2 interventional study registered as NCT04145622 by Daiichi Sankyo, with 250 participants planned, started 2019-11-03 and due to reach its primary completion in 2027-04-30. Interventions recorded: Ifinatamab deruxtecan (I-DXd).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04145622","url":"https://clinicaltrials.gov/study/NCT04145622"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["ifinatamab-deruxtecan"],"companies":["daiichi-sankyo","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04145622","phase":"1/2","setting":"Phase I/II, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects With Advanced Solid Malignant Tumors (IDeate-PanTumor01)","sponsor":"Daiichi Sankyo","started":"2019-11-03","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03386513","kind":"trial","name":"Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN","aka":[],"tldr":"A phase 1/2 trial of Pivekimab sunirine in blastic plasmacytoid dendritic cell neoplasm and myeloproliferative neoplasms, run by AbbVie, active and no longer recruiting.","summary":"Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN is a phase 1/2 interventional study registered as NCT03386513 by AbbVie, with 179 participants enrolled, started 2018-01-02 and due to reach its primary completion in 2024-10-02. Interventions recorded: IMGN632. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03386513","url":"https://clinicaltrials.gov/study/NCT03386513"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["bpdcn","myeloproliferative-neoplasms"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["pivekimab-sunirine"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03386513","phase":"1/2","setting":"A Phase 1/2, Multi-center, Open-label Study of IMGN632 Monotherapy Administered Intravenously in Patients With CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies","sponsor":"AbbVie","started":"2018-01-02","startedType":"actual","yearReported":2026,"enrolled":179,"enrolledBasis":"registry","outcomes":[{"endpoint":"Composite Complete Remission/Response (CCR) Rate As Assessed by Investigator in Frontline De Novo Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Participants","primary":true,"unit":"%","arms":[{"name":"Frontline De Novo BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg","n":22,"value":72.7,"note":"95% CI 49.78 to 89.27; Figures from the ClinicalTrials.gov results section (first posted 2026-09-04), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03386513?tab=results"},{"endpoint":"Overall Survival in Total R/R BPDCN Participants","unit":"months","arms":[{"name":"Total R/R BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg","n":51,"value":5.78,"note":"95% CI 3.943 to 8.378; Figures from the ClinicalTrials.gov results section (first posted 2026-09-04), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03386513?tab=results"}]},{"id":"nct03393884","kind":"trial","name":"Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)","aka":["OVATION 2"],"tldr":"A phase 1/2 trial of Carboplatin, Paclitaxel / nab-paclitaxel in ovarian cancer, run by Imunon, active and no longer recruiting.","summary":"Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2) is a phase 1/2 interventional study registered as NCT03393884 by Imunon, with 130 participants planned, started 2018-09-05 and due to reach its primary completion in 2024-07-25. Interventions recorded: IMNN-001, Carboplatin, Paclitaxel. Conditions listed: Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03393884","url":"https://clinicaltrials.gov/study/NCT03393884"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["carboplatin","paclitaxel"],"companies":["imunon"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03393884","phase":"1/2","setting":"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","sponsor":"Imunon","started":"2018-09-05","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04198766","kind":"trial","name":"Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalen","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab, Pemetrexed, Gemcitabine in non-small-cell lung cancer and small-cell lung cancer, run by Inhibrx Biosciences, Inc, now recruiting.","summary":"Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) is a phase 1/2 interventional study registered as NCT04198766 by Inhibrx Biosciences, Inc, with 340 participants planned, started 2019-12-10 and due to reach its primary completion in 2033-07. Interventions recorded: INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab 200 mg, pembrolizumab 400 mg, Carboplatin AUC-5, Carboplatin AUC-6. Conditions listed: Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04198766","url":"https://clinicaltrials.gov/study/NCT04198766"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","melanoma","rcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","pemetrexed","gemcitabine"],"companies":["inhibrx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04198766","phase":"1/2","setting":"An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors","sponsor":"Inhibrx Biosciences, Inc","started":"2019-12-10","startedType":"actual","enrolled":340,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06585410","kind":"trial","name":"Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma","aka":[],"tldr":"A phase 3 trial of Cemiplimab in cutaneous squamous cell carcinoma, run by Regeneron Pharmaceuticals, now recruiting.","summary":"Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma is a phase 3 interventional study registered as NCT06585410 by Regeneron Pharmaceuticals, with 369 participants planned, started 2025-01-02 and due to reach its primary completion in 2030-05-03. Interventions recorded: Cemiplimab, Standard of care. Conditions listed: Cutaneous Squamous Cell Carcinoma (CSCC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06585410","url":"https://clinicaltrials.gov/study/NCT06585410"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cutaneous-scc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06585410","phase":"3","setting":"A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)","sponsor":"Regeneron Pharmaceuticals","started":"2025-01-02","startedType":"actual","enrolled":369,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05403385","kind":"trial","name":"Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Carboplatin, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by iTeos Therapeutics, active and no longer recruiting.","summary":"Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT05403385 by iTeos Therapeutics, with 36 participants enrolled, started 2022-08-26 and due to reach its primary completion in 2025-06-13. Interventions recorded: inupadenant, Placebo, Carboplatin, Pemetrexed. Conditions listed: Metastatic NSCLC - Non-Small Cell Lung Cancer, Locally Advanced NSCLC - Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05403385","url":"https://clinicaltrials.gov/study/NCT05403385"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05403385","phase":"2","setting":"A Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating Efficacy and Safety of Inupadenant in Combination With Carboplatin and Pemetrexed in Adults With Nonsquamous Non-small Cell Lung Cancer Who Have Progressed on Immunotherapy","sponsor":"iTeos Therapeutics","started":"2022-08-26","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02665065","kind":"trial","name":"Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia","aka":["SIERRA"],"tldr":"A phase 3 trial of Iomab-B run by Actinium Pharmaceuticals, active.","summary":"Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia is a phase 3 interventional study registered as NCT02665065 by Actinium Pharmaceuticals, with 153 participants enrolled, started 2016-06. Conditions listed: Acute Myeloid Leukemia, Leukemia, Acute Myeloid, Myeloid Leukemia, Acute, Leukemia, Myeloid, Acute. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02665065","url":"https://clinicaltrials.gov/study/NCT02665065"}],"tags":["ctgov-ingest"],"related":[],"cancers":["aml","aml-older-unfit"],"sections":[],"technologies":["radioimmunotherapy","radioligand-therapy"],"targets":[],"drugs":["iomab-b"],"companies":["actinium-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02665065","phase":"3","setting":"A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplant Versus Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia (AML)","sponsor":"Actinium Pharmaceuticals","started":"2016-06","enrolled":153,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02952508","kind":"trial","name":"Study of Iopofosine I-131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) With Expansion in Waldenstrom","aka":["CLOVER-1"],"tldr":"A phase 2 trial of Iopofosine I 131 single dose in waldenström macroglobulinaemia, multiple myeloma, chronic lymphocytic leukaemia, non-Hodgkin lymphoma, mantle cell lymphoma and diffuse large B-cell lymphoma, run by Cellectar Biosciences, Inc., active and no longer recruiting.","summary":"Study of Iopofosine I-131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) With Expansion in Waldenstrom is a phase 2 interventional study registered as NCT02952508 by Cellectar Biosciences, Inc., with 120 participants enrolled, started 2017-07-26 and due to reach its primary completion in 2026-06-22. Interventions recorded: Iopofosine I 131 single dose, Iopofosine I 131 multiple dose and Iopofosine I 131 fractionated dose.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02952508","url":"https://clinicaltrials.gov/study/NCT02952508"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["waldenstrom","multiple-myeloma","cll","non-hodgkin-lymphoma","mantle-cell-lymphoma","dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["cellectar"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02952508","phase":"2","setting":"An Open-Label, Multicenter, Phase 2 Study of Iopofosine I 131 (CLR 131) in Patients With Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients With Waldenstrom Macroglobulinemia (CLOVER-WaM)","sponsor":"Cellectar Biosciences, Inc.","started":"2017-07-26","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05862012","kind":"trial","name":"Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)","aka":["TRIgnite-1"],"tldr":"A phase 1 trial of ISB 2001 in Multiple myeloma, run by Ichnos Sciences SA, now recruiting.","summary":"Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1) is a phase 1 interventional study registered as NCT05862012 by Ichnos Sciences SA, with 200 participants planned, started 2023-11-01 and due to reach its primary completion in 2027-07. Interventions recorded: ISB 2001, ISB 2001. Conditions recorded: Relapsed/Refractory Multiple Myeloma.\n\nLinked to the drug ISB 2001 because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05862012","url":"https://clinicaltrials.gov/study/NCT05862012"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["isb-2001"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05862012","phase":"1","setting":"A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects With Relapsed/Refractory Multiple Myeloma","sponsor":"Ichnos Sciences SA","started":"2023-11-01","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06414460","kind":"trial","name":"Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ISM3412 in advanced solid tumours, run by InSilico Medicine Hong Kong Limited, now recruiting.","summary":"Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT06414460 by InSilico Medicine Hong Kong Limited, with 146 participants planned, started 2025-04-25 and due to reach its primary completion in 2028-03-31. Interventions recorded: ISM3412.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06414460","url":"https://clinicaltrials.gov/study/NCT06414460"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["insilico-medicine"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06414460","phase":"1/2","setting":"A Phase 1/2, Open-Label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Preliminary Efficacy of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors","sponsor":"InSilico Medicine Hong Kong Limited","started":"2025-04-25","startedType":"actual","enrolled":146,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06566079","kind":"trial","name":"Study of ISM6331 in Participants With Advanced/Metastatic Mesothelioma or Other Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ISM6331 in mesothelioma, run by InSilico Medicine Hong Kong Limited, now recruiting.","summary":"Study of ISM6331 in Participants With Advanced/Metastatic Mesothelioma or Other Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06566079 by InSilico Medicine Hong Kong Limited, with 160 participants planned, started 2024-12-27 and due to reach its primary completion in 2027-08-31. Interventions recorded: ISM6331.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06566079","url":"https://clinicaltrials.gov/study/NCT06566079"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mesothelioma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["insilico-medicine"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06566079","phase":"1/2","setting":"A Phase 1/2, Open-Label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Preliminary Efficacy of ISM6331 in Participants With Advanced/Metastatic Mesothelioma or Other Advanced Solid Tumors","sponsor":"InSilico Medicine Hong Kong Limited","started":"2024-12-27","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07680790","kind":"trial","name":"Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based C","aka":[],"tldr":"A phase 3 trial of izalontamab brengitecan, osimertinib, pemetrexed, carboplatin and other drugs in lung cancer, run by Bristol-Myers Squibb, not yet recruiting.","summary":"Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02) is a phase 3, randomised interventional study registered as NCT07680790 by Bristol-Myers Squibb, with a registry enrolment figure of 850 participants, started 2026-09-30 and due to reach its primary completion in 2031-12-30. Interventions recorded: Iza-bren; Osimertinib; Pemetrexed; Carboplatin; Cisplatin. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Progression-Free Survival (PFS) using blinded independent central review (BICR) assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Lung eligibility wording from the registry: \"* Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB/IIIC), metastatic (Stage IVA/IVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment\". Sites: Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, South Korea, Spain and 4 more countries. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07680790","url":"https://clinicaltrials.gov/study/NCT07680790"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","platinum"],"targets":[],"drugs":["izalontamab-brengitecan","osimertinib","pemetrexed","carboplatin","cisplatin"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07680790","phase":"3","setting":"A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"Bristol-Myers Squibb","started":"2026-09-30","startedType":"estimated","enrolled":850,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07100080","kind":"trial","name":"Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy","aka":["IZABRIGHT-Lung01"],"tldr":"A phase 2/3 trial of Izalontamab brengitecan, Carboplatin, Cisplatin in non-small-cell lung cancer and small-cell lung cancer, run by Bristol-Myers Squibb, now recruiting.","summary":"Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01) is a phase 2/3 interventional study registered as NCT07100080 by Bristol-Myers Squibb, with 500 participants planned, started 2025-11-05 and due to reach its primary completion in 2028-12-15. Interventions recorded: Iza-bren, Carboplatin, Cisplatin, Pemetrexed. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07100080","url":"https://clinicaltrials.gov/study/NCT07100080"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["adc","bispecific-adc","cytotoxic-chemotherapy"],"targets":[],"drugs":["izalontamab-brengitecan","carboplatin","cisplatin","pemetrexed"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07100080","phase":"2/3","setting":"IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy","sponsor":"Bristol-Myers Squibb","started":"2025-11-05","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07640295","kind":"trial","name":"Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations","aka":[],"tldr":"A phase 1/2 trial of Gemcitabine in pancreatic ductal adenocarcinoma, run by Jacobio Pharmaceuticals Co., Ltd., now recruiting.","summary":"Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations is a phase 1/2 interventional study registered as NCT07640295 by Jacobio Pharmaceuticals Co., Ltd., with 80 participants planned, started 2026-07-16 and due to reach its primary completion in 2029-12-31. Interventions recorded: JAB-23E73 tablet，nab-paclitaxel，gemcitabine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07640295","url":"https://clinicaltrials.gov/study/NCT07640295"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":["jacobio-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07640295","phase":"1/2","setting":"A Multicenter, Phase Ib/III Study to Evaluate JAB-23E73 in Combination With Nab-Paclitaxel and Gemcitabine in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Harboring KRAS Gene Alterations","sponsor":"Jacobio Pharmaceuticals Co., Ltd.","started":"2026-07-16","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05132075","kind":"trial","name":"Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer","aka":["KontRASt-02"],"tldr":"A phase 3 trial testing JDQ443 in non-small-cell lung cancer, active and no longer recruiting.","summary":"Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT05132075, led by Novartis Pharmaceuticals, and active but no longer recruiting on the registry. Official title: A Randomised, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer. Planned enrolment is 95 participants (actual). The study started in 2022-06-15 and primary completion is expected in 2026-08-25. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05132075","url":"https://clinicaltrials.gov/study/NCT05132075"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["jdq443"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05132075","phase":"3","setting":"A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer","sponsor":"Novartis Pharmaceuticals","started":"2022-06-15","startedType":"actual","enrolled":95,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04699188","kind":"trial","name":"Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation","aka":["KontRASt-01"],"tldr":"A phase 1/2 trial of JDQ443, TNO155 and Tislelizumab in non-small-cell lung cancer and colorectal cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation is a phase 1/2 interventional study registered as NCT04699188 by Novartis Pharmaceuticals, with 344 participants enrolled, started 2021-02-24 and due to reach its primary completion in 2027-01-25. Interventions recorded: JDQ443, TNO155 and tislelizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04699188","url":"https://clinicaltrials.gov/study/NCT04699188"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","colorectal","kras-g12c-colorectal","kras-g12c-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["jdq443","tno155","tislelizumab"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04699188","phase":"1/2","setting":"A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation","sponsor":"Novartis Pharmaceuticals","started":"2021-02-24","startedType":"actual","enrolled":344,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06667960","kind":"trial","name":"Study of JK06 in Patients With Unresectable Locally Advanced or Metastatic Cancer","aka":[],"tldr":"A phase 1/2 trial of JK06 in advanced solid tumours, run by Salubris Biotherapeutics Inc, now recruiting.","summary":"Study of JK06 in Patients With Unresectable Locally Advanced or Metastatic Cancer is a phase 1/2 interventional study registered as NCT06667960 by Salubris Biotherapeutics Inc, with 255 participants planned, started 2024-10-23 and due to reach its primary completion in 2028-04-01. Interventions recorded: JK06.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06667960","url":"https://clinicaltrials.gov/study/NCT06667960"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["salubris-biotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06667960","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK06, a 5T4 Antibody Drug Conjugate, in Patients With Unresectable Locally Advanced or Metastatic Cancer","sponsor":"Salubris Biotherapeutics Inc","started":"2024-10-23","startedType":"actual","enrolled":255,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05620134","kind":"trial","name":"Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer","aka":[],"tldr":"A phase 1/2 trial of JK08, Pembrolizumab in metastatic cancer and melanoma, run by Salubris Biotherapeutics Inc, active and no longer recruiting.","summary":"Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer is a phase 1/2 interventional study registered as NCT05620134 by Salubris Biotherapeutics Inc, with 263 participants planned, started 2022-10-17 and due to reach its primary completion in 2025-10-17. Interventions recorded: JK08, Pembrolizumab, Lenvatinib Pill. Conditions listed: Cancer, Tumor, Solid, Advanced Solid Tumor, Metastatic Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05620134","url":"https://clinicaltrials.gov/study/NCT05620134"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","melanoma","colorectal","nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["jk08","pembrolizumab"],"companies":["salubris-biotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05620134","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK08, an IL-15 Antibody Fusion Protein Targeting CTLA-4, Monotherapy or in Combination in Patients with Unresectable Locally Advanced or Metastatic Cancer","sponsor":"Salubris Biotherapeutics Inc","started":"2022-10-17","startedType":"actual","enrolled":263,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06942234","kind":"trial","name":"Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of JSKN016, Capecitabine, Eribulin and Pembrolizumab in advanced solid tumours, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd, now recruiting.","summary":"Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer is a phase 1/2 interventional study registered as NCT06942234 by Jiangsu Alphamab Biopharmaceuticals Co., Ltd, with 180 participants planned, started 2025-06-01 and due to reach its primary completion in 2027-06-30. Interventions recorded: JSKN016, Capecitabine, Paclitaxel (albumin bound), Eribulin and Pembrolizumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06942234","url":"https://clinicaltrials.gov/study/NCT06942234"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["jskn016","capecitabine","eribulin","pembrolizumab"],"companies":["alphamab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06942234","phase":"1/2","setting":"The Multicenter, Open-label, Single-arm, Multi-cohort Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of JSKN016 in Combination Therapy in Chinese Participants With Inoperable Locally Advanced or Metastatic HER2-negative Breast Cancer","sponsor":"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","started":"2025-06-01","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06895031","kind":"trial","name":"Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS","aka":["STAR"],"tldr":"A phase 2 trial of JYP0015 in pancreatic ductal adenocarcinoma and non-small-cell lung cancer, run by Guangzhou JOYO Pharma Co., Ltd, now recruiting.","summary":"Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS is a phase 2 interventional study registered as NCT06895031 by Guangzhou JOYO Pharma Co., Ltd, with 210 participants planned, started 2025-03-31 and due to reach its primary completion in 2026-03-30. Interventions recorded: JYP0015. Conditions listed: Solid Tumor, Pancreatic Ductal Adenocarcinoma (PDAC), Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06895031","url":"https://clinicaltrials.gov/study/NCT06895031"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","nsclc","sclc","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["jyp0015"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06895031","phase":"2","setting":"A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JYP0015 in Advanced Solid Tumors With RAS Mutation","sponsor":"Guangzhou JOYO Pharma Co., Ltd","started":"2025-03-31","startedType":"actual","enrolled":210,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06253663","kind":"trial","name":"Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic L","aka":["JKART-1"],"tldr":"A phase 2 trial of Brexucabtagene autoleucel, Cyclophosphamide, Fludarabine in mantle cell lymphoma, run by Kite, A Gilead Company, active and no longer recruiting.","summary":"Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia is a phase 2 interventional study registered as NCT06253663 by Kite, A Gilead Company, with 25 participants enrolled, started 2024-03-18 and due to reach its primary completion in 2027-07. Interventions recorded: KTE-X19, Cyclophosphamide, Fludarabine. Conditions listed: Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06253663","url":"https://clinicaltrials.gov/study/NCT06253663"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["brexucabtagene-autoleucel","cyclophosphamide","fludarabine"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06253663","phase":"2","setting":"A Phase 2 Multicenter Study Evaluating the Safety and the Efficacy of KTE-X19 in Adult Japanese Subjects With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia","sponsor":"Kite, A Gilead Company","started":"2024-03-18","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04299191","kind":"trial","name":"Study of LAM561 Acid in Pediatric Patients With Malignant Glioma and Other Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of LAM561 in glioma & glioblastoma, run by Laminar Pharmaceuticals, now recruiting.","summary":"Study of LAM561 Acid in Pediatric Patients With Malignant Glioma and Other Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT04299191 by Laminar Pharmaceuticals, with 28 participants planned, started 2020-09-01 and due to reach its primary completion in 2026-10. Interventions recorded: LAM561.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04299191","url":"https://clinicaltrials.gov/study/NCT04299191"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":["lam561"],"companies":["laminar-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04299191","phase":"1/2","setting":"Study of LAM561 Acid in Pediatric Patients With Malignant Glioma and Other Advanced Solid Tumors","sponsor":"Laminar Pharmaceuticals","started":"2020-09-01","startedType":"actual","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04415853","kind":"trial","name":"Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer","aka":[],"tldr":"A phase 3 trial testing Lerotinib in oesophageal cancer, now recruiting.","summary":"Study of Larotinib in Unresectable Advanced or Recurrent Oesophageal Cancer is a phase 3 interventional study registered as NCT04415853, led by Sunshine Lake Pharma, and recruiting on the registry. Official title: Lerotinib Versus Investigator's Choice Single-agent Chemotherapy in Patients With Locally Advanced/Metastatic Oesophageal Squamous Cell Carcinoma and EGFR Overexpression That Progressed After Second-line Therapy:Phase 3 Study. Planned enrolment is 416 participants (estimated). The study started in 2021-01-21 and primary completion is expected in 2026-08. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04415853","url":"https://clinicaltrials.gov/study/NCT04415853"}],"tags":["ctgov-ingest"],"related":[],"cancers":["esophageal","oesophageal-squamous-cell-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["lerotinib"],"companies":["sunshine-lake-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04415853","phase":"3","setting":"Lerotinib Versus Investigator's Choice Single-agent Chemotherapy in Patients With Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma and EGFR Overexpression That Progressed After Second-line Therapy:Phase 3 Study","sponsor":"Sunshine Lake Pharma","started":"2021-01-21","startedType":"actual","enrolled":416,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01872260","kind":"trial","name":"Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of LEE011 in advanced solid tumours, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer is a phase 1/2 interventional study registered as NCT01872260 by Novartis Pharmaceuticals, with 255 participants enrolled, started 2013-10-22 and due to reach its primary completion in 2027-02-26. Interventions recorded: LEE011, Letrozole and BYL719.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01872260","url":"https://clinicaltrials.gov/study/NCT01872260"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01872260","phase":"1/2","setting":"A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer","sponsor":"Novartis Pharmaceuticals","started":"2013-10-22","startedType":"actual","enrolled":255,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05768919","kind":"trial","name":"Study of Liposomal Curcumin in Combination With RT and TMZ in Patients With Newly Diagnosed High-Grade Gliomas","aka":[],"tldr":"A phase 1/2 trial of Treatment Period 1 in glioma & glioblastoma, run by SignPath Pharma, Inc., now recruiting.","summary":"Study of Liposomal Curcumin in Combination With RT and TMZ in Patients With Newly Diagnosed High-Grade Gliomas is a phase 1/2 interventional study registered as NCT05768919 by SignPath Pharma, Inc., with 30 participants planned, started 2023-03-03 and due to reach its primary completion in 2026-02. Interventions recorded: Treatment Period 1, Treatment Period 2, Treatment Period 3 and Treatment Period 4a.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05768919","url":"https://clinicaltrials.gov/study/NCT05768919"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05768919","phase":"1/2","setting":"Phase I/II Study of the Tolerability, Safety, and Efficacy of Liposomal Curcumin in Combination With Radiation and Temozolomide in Patients With Newly Diagnosed High-Grade Gliomas","sponsor":"SignPath Pharma, Inc.","started":"2023-03-03","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04501120","kind":"trial","name":"Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML","aka":[],"tldr":"A phase 1/2 trial of Azacitidine, Olverembatinib in acute myeloid leukaemia, run by Ascentage Pharma Group Inc., now recruiting.","summary":"Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML is a phase 1/2 interventional study registered as NCT04501120 by Ascentage Pharma Group Inc., with 682 participants planned, started 2020-09-28 and due to reach its primary completion in 2028-09. Interventions recorded: Lisaftoclax (APG-2575), Reduced-dose HHT, standard-dose HHT, Azacitidine, Lisaftoclax (APG-2575). Conditions listed: Relapsed/Refractory Acute Myeloid Leukaemia, Myeloid Malignancy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04501120","url":"https://clinicaltrials.gov/study/NCT04501120"}],"tags":["ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["azacitidine","olverembatinib","omacetaxine"],"companies":["ascentage-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04501120","phase":"1/2","setting":"A Phase Ib Study of the Safety, Pharmacokinetic of Lisaftoclax (APG-2575) Single Agent and in Combination With Homoharringtonine or Azacitidine in Patients With Relapsed/Refractory AML","sponsor":"Ascentage Pharma Group Inc.","started":"2020-09-28","startedType":"actual","enrolled":682,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06650566","kind":"trial","name":"Study of LM-299 in Subjects Advanced Malignant Tumors","aka":[],"tldr":"A phase 1/2 trial of LM-299 in advanced solid tumours, run by LaNova Medicines Limited, now recruiting.","summary":"Study of LM-299 in Subjects Advanced Malignant Tumors is a phase 1/2 interventional study registered as NCT06650566 by LaNova Medicines Limited, with 108 participants planned, started 2024-10-09 and due to reach its primary completion in 2026-12. Interventions recorded: LM-299.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06650566","url":"https://clinicaltrials.gov/study/NCT06650566"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["lanova-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06650566","phase":"1/2","setting":"A Phase I/II, Open-label, Dose Escalation and Dose Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of LM-299 Injection as Monotherapy or in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors","sponsor":"LaNova Medicines Limited","started":"2024-10-09","startedType":"actual","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05933265","kind":"trial","name":"Study of LP-184 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Olaparib, Ipilimumab and Nivolumab in triple-negative breast cancer, non-small-cell lung cancer and pancreatic ductal adenocarcinoma, run by Lantern Pharma Inc., active and no longer recruiting.","summary":"Study of LP-184 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05933265 by Lantern Pharma Inc., with 64 participants enrolled, started 2023-06-09 and due to reach its primary completion in 2026-07-28. Interventions recorded: LP-184, Olaparib and Nivolumab & Ipilimumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05933265","url":"https://clinicaltrials.gov/study/NCT05933265"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","nsclc","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["olaparib","ipilimumab","nivolumab","lp-184"],"companies":["lantern-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05933265-invest-new-drugs-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05933265","phase":"1/2","setting":"A Phase 1/2 Dose Escalation and Cohort Expansion Study of LP-184 in Patients With Advanced or Metastatic Solid Tumors","sponsor":"Lantern Pharma Inc.","started":"2023-06-09","startedType":"actual","enrolled":64,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06088290","kind":"trial","name":"Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)","aka":["SaLuDo"],"tldr":"A phase 3 trial of Lurbinectedin and Doxorubicin in uterine sarcoma, run by PharmaMar, active and no longer recruiting.","summary":"Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo) is a phase 3 interventional study registered as NCT06088290 by PharmaMar, with 469 participants enrolled, started 2023-09-21 and due to reach its primary completion in 2029-08-30. Interventions recorded: Lurbinectedin and Doxorubicin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06088290","url":"https://clinicaltrials.gov/study/NCT06088290"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["uterine-sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["lurbinectedin","doxorubicin"],"companies":["pharmamar"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06088290","phase":"3","setting":"Randomized, Controlled, Open-label, Phase III Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Patients With Metastatic Leiomyosarcoma","sponsor":"PharmaMar","started":"2023-09-21","startedType":"actual","enrolled":469,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05734066","kind":"trial","name":"Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma","aka":[],"tldr":"A phase 1/2 trial of Lurbinectedin in ewing sarcoma, run by Jazz Pharmaceuticals, now recruiting.","summary":"Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma is a phase 1/2 interventional study registered as NCT05734066 by Jazz Pharmaceuticals, with 60 participants planned, started 2023-05-23 and due to reach its primary completion in 2028-01-28. Interventions recorded: Lurbinectedin. Conditions listed: Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma, Ewing Sarcoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05734066","url":"https://clinicaltrials.gov/study/NCT05734066"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ewing-sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["lurbinectedin"],"companies":["jazz"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05734066","phase":"1/2","setting":"A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants With Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma.","sponsor":"Jazz Pharmaceuticals","started":"2023-05-23","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06004661","kind":"trial","name":"Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function","aka":[],"tldr":"A phase 2 trial of Lutetium-177 vipivotide tetraxetan in prostate cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function is a phase 2 interventional study registered as NCT06004661 by Novartis Pharmaceuticals, with 23 participants enrolled, started 2024-04-04 and due to reach its primary completion in 2026-12-14. Interventions recorded: AAA617, 68Ga-PSMA-11. Conditions listed: Metastatic Castration-Resistant Prostate Cancer (mCRPC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06004661","url":"https://clinicaltrials.gov/study/NCT06004661"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["radioligand-therapy"],"targets":[],"drugs":["pluvicto"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06004661","phase":"2","setting":"An Open-label Dosimetry, Biodistribution, Tolerability and Safety Study of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Moderately and Severely Impaired and With Normal Renal Function.","sponsor":"Novartis Pharmaceuticals","started":"2024-04-04","startedType":"actual","enrolled":23,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06128837","kind":"trial","name":"Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of Topotecan in small-cell lung cancer, run by Luye Pharma Group Ltd., now recruiting.","summary":"Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06128837 by Luye Pharma Group Ltd., with 686 participants planned, started 2024-03-03 and due to reach its primary completion in 2028-06. Interventions recorded: Irinotecan hydrochloride liposome Injection, Topotecan. Conditions listed: Relapsed Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06128837","url":"https://clinicaltrials.gov/study/NCT06128837"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["topotecan"],"companies":["luye-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06128837","phase":"3","setting":"A Multicenter, Randomized, Open-label, Parallel-design Phase 3 Study to Evaluate the Efficacy and Safety of LY01610 (Irinotecan Hydrochloride Liposome Injection) Versus Topotecan in Patients With Recurrent Small Cell Lung Cancer (SCLC)","sponsor":"Luye Pharma Group Ltd.","started":"2024-03-03","startedType":"actual","enrolled":686,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04956640","kind":"trial","name":"Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)","aka":[],"tldr":"A phase 1/2 trial of Olomorasib, Pembrolizumab, Cetuximab, Pemetrexed, Cisplatin and Carboplatin in non-small-cell lung cancer, colorectal cancer, endometrial cancer, ovarian cancer, pancreatic ductal adenocarcinoma and biliary tract cancer, run by Eli Lilly and Company, active and no longer recruiting.","summary":"Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C) is a phase 1/2 interventional study registered as NCT04956640 by Eli Lilly and Company, with 540 participants enrolled, started 2021-07-19 and due to reach its primary completion in 2027-04. Interventions recorded: LY3537982, Pembrolizumab, Cetuximab, Pemetrexed, Cisplatin and Carboplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04956640","url":"https://clinicaltrials.gov/study/NCT04956640"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","colorectal","endometrial","ovarian","pancreatic","cholangiocarcinoma","kras-g12c-colorectal","kras-g12c-nsclc","kras-g12c-pdac"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["olomorasib","pembrolizumab","cetuximab","pemetrexed","cisplatin","carboplatin"],"companies":["eli-lilly","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04956640-nat-commun-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04956640","phase":"1/2","setting":"A Phase 1/2 Study of LY3537982 in Patients With KRAS G12C-Mutant Advanced Solid Tumors","sponsor":"Eli Lilly and Company","started":"2021-07-19","startedType":"actual","enrolled":540,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04778397","kind":"trial","name":"Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated","aka":[],"tldr":"A phase 3 trial of Magrolimab, Venetoclax, Azacitidine, Cytarabine, Daunorubicin and Idarubicin in Acute myeloid leukaemia, run by Gilead Sciences, recorded as terminated on the registry.","summary":"Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated is a phase 3 interventional study registered as NCT04778397 by Gilead Sciences, with 258 participants recorded, started 2021-07-01 and due to reach its primary completion in 2024-03-25. Interventions recorded: Magrolimab, Venetoclax, Azacitidine, Cytarabine, Daunorubicin, Idarubicin, Steroidal Eye Drops. Conditions recorded: Acute Myeloid Leukemia.\n\nLinked to the drug Magrolimab because the registry names it among its interventions and Acute myeloid leukaemia among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04778397","url":"https://clinicaltrials.gov/study/NCT04778397"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":["magrolimab","venetoclax","azacitidine","cytarabine","daunorubicin","idarubicin"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04778397","phase":"3","setting":"A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia","sponsor":"Gilead Sciences","started":"2021-07-01","startedType":"actual","yearReported":2025,"enrolled":258,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS) in Participants Appropriate for Non-intensive Therapy","primary":true,"unit":"months","arms":[{"name":"Magrolimab + Azacitidine (Non-Intensive Therapy)","n":101,"value":4.4,"note":"95% CI 3.6 to 6.0; Figures from the ClinicalTrials.gov results section (first posted 2025-02-05), not from a publication"},{"name":"Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy)","n":104,"value":6.6,"note":"95% CI 4.8 to 8.1"}],"hr":1.132,"ci":[0.783,1.637],"p":"0.5070","source":"https://clinicaltrials.gov/study/NCT04778397?tab=results"}]},{"id":"nct05079230","kind":"trial","name":"Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia","aka":[],"tldr":"A phase 3 trial of Magrolimab, Venetoclax and Azacitidine in Acute myeloid leukaemia, run by Gilead Sciences, recorded as terminated on the registry.","summary":"Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia is a phase 3 interventional study registered as NCT05079230 by Gilead Sciences, with 378 participants recorded, started 2022-07-07 and due to reach its primary completion in 2024-04-11. Interventions recorded: Magrolimab, Venetoclax, Azacitidine, Placebo. Conditions recorded: Acute Myeloid Leukemia.\n\nLinked to the drug Magrolimab because the registry names it among its interventions and Acute myeloid leukaemia among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05079230","url":"https://clinicaltrials.gov/study/NCT05079230"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-older-unfit"],"sections":[],"technologies":[],"targets":[],"drugs":["magrolimab","venetoclax","azacitidine"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05079230","phase":"3","setting":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy","sponsor":"Gilead Sciences","started":"2022-07-07","startedType":"actual","yearReported":2025,"enrolled":378,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Magrolimab + Venetoclax + Azacitidine","n":189,"value":10.7,"note":"95% CI 8.7 to 14.9; Figures from the ClinicalTrials.gov results section (first posted 2025-04-04), not from a publication"},{"name":"Magrolimab Matching Placebo + Venetoclax + Azacitidine","n":189,"value":14.1,"note":"95% CI 9.7 to NA"}],"hr":1.178,"ci":[0.848,1.637],"p":"0.3276","source":"https://clinicaltrials.gov/study/NCT05079230?tab=results"}]},{"id":"nct07448116","kind":"trial","name":"Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors.","aka":[],"tldr":"A phase 1/2 trial of MCLA-129 and Ensartinib in advanced solid tumours, run by Betta Pharmaceuticals Co., Ltd., now recruiting.","summary":"Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors. is a phase 1/2 interventional study registered as NCT07448116 by Betta Pharmaceuticals Co., Ltd., with 164 participants planned, started 2026-01-31 and due to reach its primary completion in 2029-02-01. Interventions recorded: MCLA-129 and Ensartinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07448116","url":"https://clinicaltrials.gov/study/NCT07448116"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["mcla-129","ensartinib"],"companies":["betta"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07448116","phase":"1/2","setting":"A Multi-cohort, Open-label Phase I/II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of the Anti-EGFR/c-Met Bispecific Antibody MCLA-129 in Combination With Ensartinib Hydrochloride in Patients With Advanced Solid Tumors.","sponsor":"Betta Pharmaceuticals Co., Ltd.","started":"2026-01-31","startedType":"actual","enrolled":164,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06885840","kind":"trial","name":"Study of MCLA-129 in the Treatment of Advanced Non-small Cell Lung Cancer with AGA and MET Amplification.","aka":[],"tldr":"A phase 2 trial of MCLA-129 in lung cancer, run by Betta Pharmaceuticals Co., Ltd., not yet recruiting.","summary":"Study of MCLA-129 in the Treatment of Advanced Non-small Cell Lung Cancer with AGA and MET Amplification. is a phase 2, interventional study registered as NCT06885840 by Betta Pharmaceuticals Co., Ltd., with a registry enrolment figure of 100 participants, started 2025-03-31 and due to reach its primary completion in 2028-04. Interventions recorded: MCLA-129. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Overall Response Rate (ORR). Lung eligibility wording from the registry: \"* Subjects must have histologically or cytologically confirmed locally advanced unresectable or metastatic NSCLC\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06885840","url":"https://clinicaltrials.gov/study/NCT06885840"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","met-altered-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["mcla-129"],"companies":["betta"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06885840","phase":"2","setting":"A Multi-cohort, Open-label Phase II Study to Evaluate the Efficacy and Safety of the Anti-EGFR/c-Met Bispecific Antibody MCLA-129 in Patients with Advanced Non-Small Cell Lung Cancer with Actionable Gene Alterations and MET Amplification.","sponsor":"Betta Pharmaceuticals Co., Ltd.","started":"2025-03-31","startedType":"estimated","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04930432","kind":"trial","name":"Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of MCLA-129 in non-small-cell lung cancer and small-cell lung cancer, run by Betta Pharmaceuticals Co., Ltd., now recruiting.","summary":"Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors is a phase 1/2 interventional study registered as NCT04930432 by Betta Pharmaceuticals Co., Ltd., with 400 participants planned, started 2021-09-24 and due to reach its primary completion in 2028-04-30. Interventions recorded: MCLA-129. Conditions listed: Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04930432","url":"https://clinicaltrials.gov/study/NCT04930432"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["mcla-129"],"companies":["betta"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04930432","phase":"1/2","setting":"A Phase I/II Study of MCLA-129, a Human Anti-EGFR and Anti-c-Met Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors, Evaluating Safety, Pharmacokinetic Characteristics and Antitumor Activity","sponsor":"Betta Pharmaceuticals Co., Ltd.","started":"2021-09-24","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02516241","kind":"trial","name":"Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer","aka":[],"tldr":"A phase 3 trial of Durvalumab, Tremelimumab, Cisplatin, Carboplatin and Gemcitabine in bladder & urothelial cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer is a phase 3 interventional study registered as NCT02516241 by AstraZeneca, with 1126 participants enrolled, started 2015-11-02 and due to reach its primary completion in 2020-01-27. Interventions recorded: MEDI4736 (Durvalumab), Tremelimumab, Cisplatin, Carboplatin and Gemcitabine. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02516241","url":"https://clinicaltrials.gov/study/NCT02516241"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab","cisplatin","carboplatin","gemcitabine"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02516241","phase":"3","setting":"A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer","sponsor":"AstraZeneca","started":"2015-11-02","startedType":"actual","yearReported":2021,"enrolled":1126,"enrolledBasis":"registry","outcomes":[{"endpoint":"To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set","primary":true,"unit":"months","arms":[{"name":"Combination Therapy","n":342,"value":15.1,"note":"95% CI 13.1 to 18.0; Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication"},{"name":"Standard of Care","n":344,"value":12.1,"note":"95% CI 10.9 to 14"}],"hr":0.85,"p":"0.0751","source":"https://clinicaltrials.gov/study/NCT02516241?tab=results"},{"endpoint":"To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set","primary":true,"unit":"months","arms":[{"name":"Monotherapy","n":209,"value":14.4,"note":"95% CI 10.4 to 17.3; Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication"},{"name":"Standard of Care","n":207,"value":12.1,"note":"95% CI 10.4 to 15.0"}],"hr":0.89,"p":"0.3039","source":"https://clinicaltrials.gov/study/NCT02516241?tab=results"},{"endpoint":"PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC","unit":"months","arms":[{"name":"Combination Therapy","n":342,"value":3.7,"note":"95% CI 3.4 to 3.8; Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication"},{"name":"Monotherapy","n":346,"value":2.3,"note":"95% CI 1.9 to 3.5"},{"name":"Standard of Care","n":344,"value":6.7,"note":"95% CI 5.7 to 7.3"}],"source":"https://clinicaltrials.gov/study/NCT02516241?tab=results"},{"endpoint":"Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC","unit":"%","arms":[{"name":"Combination Therapy","n":342,"value":36.3,"note":"Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication"},{"name":"Monotherapy","n":346,"value":25.7},{"name":"Standard of Care","n":344,"value":49.1}],"source":"https://clinicaltrials.gov/study/NCT02516241?tab=results"}]},{"id":"nct04649060","kind":"trial","name":"Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma","aka":[],"tldr":"A phase 3 trial of Melphalan flufenamide, Dexamethasone and Daratumumab in Multiple myeloma, run by Oncopeptides AB, recorded as terminated on the registry.","summary":"Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma is a phase 3 interventional study registered as NCT04649060 by Oncopeptides AB, with 54 participants recorded, started 2020-12-21 and due to reach its primary completion in 2022-02-07. Interventions recorded: Melflufen, Dexamethasone, Daratumumab. Conditions recorded: Relapsed Multiple Myeloma, Relapsed-Refractory Multiple Myeloma.\n\nLinked to the drug Melphalan flufenamide because the registry names it among its interventions and Multiple myeloma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04649060","url":"https://clinicaltrials.gov/study/NCT04649060"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":["melflufen","dexamethasone","daratumumab"],"companies":["oncopeptides"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04649060","phase":"3","setting":"A Randomized, Controlled, Open-Label Phase 3 Study of Melflufen in Combination With Daratumumab Compared With Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma","sponsor":"Oncopeptides AB","started":"2020-12-21","startedType":"actual","yearReported":2023,"enrolled":54,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Arm A (Melflufen+Dexamethasone+Daratumumab)","n":27,"note":"The median PFS was not reached in Arm A. There were insufficient numbers of participants with events.; Figures from the ClinicalTrials.gov results section (first posted 2023-06-08), not from a publication"},{"name":"Arm B (Daratumumab)","n":27,"value":4.86,"note":"95% CI 3.38 to NA"}],"hr":0.184,"ci":[0.052,0.65],"p":"0.0032","source":"https://clinicaltrials.gov/study/NCT04649060?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Arm A (Melflufen+Dexamethasone+Daratumumab)","n":27,"value":11.04,"note":"95% CI NA to NA; Figures from the ClinicalTrials.gov results section (first posted 2023-06-08), not from a publication"},{"name":"Arm B (Daratumumab)","n":27,"note":"The median OS was not reached in Arm B and the 95% CI was not available due to insufficient numbers of participants with events."}],"hr":0.47,"ci":[0.086,2.569],"p":"0.3721","source":"https://clinicaltrials.gov/study/NCT04649060?tab=results"},{"endpoint":"Overall Response Rate (ORR)","unit":"%","arms":[{"name":"Arm A (Melflufen+Dexamethasone+Daratumumab)","n":27,"value":59.3,"note":"95% CI 38.8 to 77.6; Figures from the ClinicalTrials.gov results section (first posted 2023-06-08), not from a publication"},{"name":"Arm B (Daratumumab)","n":27,"value":29.6,"note":"95% CI 13.8 to 50.2"}],"p":"0.03","source":"https://clinicaltrials.gov/study/NCT04649060?tab=results"}]},{"id":"nct07102004","kind":"trial","name":"Study of MHB088C for Patients With Advanced Solid Malignant Tumors","aka":[],"tldr":"A phase 1/2 trial of QLC5508 in advanced solid tumours, run by Qilu Pharmaceutical Co., Ltd., now recruiting.","summary":"Study of MHB088C for Patients With Advanced Solid Malignant Tumors is a phase 1/2 interventional study registered as NCT07102004 by Qilu Pharmaceutical Co., Ltd., with 515 participants planned, started 2023-06-20 and due to reach its primary completion in 2026-07. Interventions recorded: MHB088C for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07102004","url":"https://clinicaltrials.gov/study/NCT07102004"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["qlc5508"],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07102004","phase":"1/2","setting":"A Phase I/II Study of MHB088C for Patients With Advanced Malignant Solid Tumors","sponsor":"Qilu Pharmaceutical Co., Ltd.","started":"2023-06-20","startedType":"actual","enrolled":515,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05673057","kind":"trial","name":"Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome","aka":[],"tldr":"A phase 1/2 trial of Azacitidine, Venetoclax and Obinutuzumab in acute myeloid leukaemia, run by Molecular Partners AG, active and no longer recruiting.","summary":"Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome is a phase 1/2 interventional study registered as NCT05673057 by Molecular Partners AG, with 249 participants enrolled, started 2022-12-29 and due to reach its primary completion in 2026-05-29. Interventions recorded: MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 1, MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 2-Arm A, MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) + azacitidine + venetoclax, MP0533 with Obinutuzumab pretreatment, MP0533 + azacitidine + venetoclax with optional Obinutuzumab pretreatment, Arm B relapsed/refractory AML and MP0533 + azacitidine + venetoclax with optional Obinutuzumab pretreatment, Arm B in treatment naïve patients.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05673057","url":"https://clinicaltrials.gov/study/NCT05673057"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":["azacitidine","venetoclax","obinutuzumab"],"companies":["molecular-partners"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05673057","phase":"1/2","setting":"A Phase 1/2a, First-in-human, Open-label, Multicenter, Dose Escalation Study of MP0533 in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)","sponsor":"Molecular Partners AG","started":"2022-12-29","startedType":"actual","enrolled":249,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05533697","kind":"trial","name":"Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab, Ipilimumab and Nivolumab in advanced solid tumours, run by ModernaTX, Inc., now recruiting.","summary":"Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05533697 by ModernaTX, Inc., with 361 participants planned, started 2022-09-01 and due to reach its primary completion in 2032-02-18. Interventions recorded: mRNA-4359, Pembrolizumab, Ipilimumab and Nivolumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05533697","url":"https://clinicaltrials.gov/study/NCT05533697"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","ipilimumab","nivolumab"],"companies":["moderna"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05533697","phase":"1/2","setting":"Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors","sponsor":"ModernaTX, Inc.","started":"2022-09-01","startedType":"actual","enrolled":361,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05737706","kind":"trial","name":"Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation","aka":["MRTX1133 phase 1/2"],"tldr":"A phase 1 trial of MRTX1133 in Non-small-cell lung cancer and Rectal cancer, run by Mirati Therapeutics Inc., recorded as terminated on the registry.","summary":"Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation is a phase 1 interventional study registered as NCT05737706 by Mirati Therapeutics Inc., with 63 participants recorded, started 2023-03-06 and due to reach its primary completion in 2025-03-10. Interventions recorded: MRTX1133. Conditions recorded: Solid Tumor, Advanced Solid Tumor, Non-small Cell Lung Cancer, Colo-rectal Cancer, Pancreatic Adenocarcinoma.\n\nLinked to the drug MRTX1133 because the registry names it among its interventions and Non-small-cell lung cancer and Rectal cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05737706","url":"https://clinicaltrials.gov/study/NCT05737706"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["mrtx1133"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["pancreatic-failed-programmes","kras-mutation-subtypes"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registry status on 24 September 2026: terminated, 63 participants (actual), started 6 March 2023 and completed 10 March 2025, United States sites only; no results posted and no publication found in Europe PMC. It was the first KRAS G12D inhibitor in the clinic; the G12D programmes now in phase 3 are zoldonrasib's RASolute 305 and 309."],"nct":"NCT05737706","phase":"1","setting":"A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation","sponsor":"Mirati Therapeutics Inc.","started":"2023-03-06","startedType":"actual","enrolled":63,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05254171","kind":"trial","name":"Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer","aka":["ASPIRE"],"tldr":"A phase 2/3 trial testing Ivospemin in pancreatic ductal adenocarcinoma, now recruiting.","summary":"Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer is a phase 2/3 interventional study registered as NCT05254171, led by Panbela Therapeutics, and recruiting on the registry. Official title: A Randomised, Double-Blind, Placebo-Controlled Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma. Planned enrolment is 600 participants (estimated). The study started in 2022-08-08 and primary completion is expected in 2026-08-29. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05254171","url":"https://clinicaltrials.gov/study/NCT05254171"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["ivospemin"],"companies":["panbela-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05254171","phase":"2/3","setting":"A Randomized, Double-Blind, Placebo-Controlled Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma","sponsor":"Panbela Therapeutics","started":"2022-08-08","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06783140","kind":"trial","name":"Study of NABPLAGEM vs. Nab-Paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Pancreatic Cancer","aka":["PLATINUM-CAN"],"tldr":"A phase 2/3 trial of nab-paclitaxel, gemcitabine and cisplatin in pancreatic cancer, run by University Health Network, Toronto, active but no longer recruiting.","summary":"Study of NABPLAGEM vs. Nab-Paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Pancreatic Cancer is a phase 2/3, randomised interventional study registered as NCT06783140 by University Health Network, Toronto, with a registry enrolment figure of 10 participants, started 2025-06-10 and due to reach its primary completion in 2031-06-02. Interventions recorded: Nab paclitaxel; Gemcitabine; Cisplatin. Conditions listed: Pancreatic Cancer, Advanced or Metastatic; BRCA1/2 Mutation; PALB2 Gene Mutation. Primary outcome: Overall Response Rate (ORR); Overall Survival (OS) Time. Pancreatic eligibility wording from the registry: \"* Metastatic pancreatic adenocarcinoma\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06783140","url":"https://clinicaltrials.gov/study/NCT06783140"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac","brca-palb2-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["nab-paclitaxel","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06783140","phase":"2/3","setting":"Comparing Second-Line NABPLAGEM vs. Nab-paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Mutant Metastatic Pancreatic Ductal Adenocarcinoma","sponsor":"University Health Network, Toronto","started":"2025-06-10","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05797831","kind":"trial","name":"Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer","aka":[],"tldr":"A phase 2/3 trial of KRT-232 in endometrial cancer, run by Kartos Therapeutics, Inc., now recruiting.","summary":"Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer is a phase 2/3 interventional study registered as NCT05797831 by Kartos Therapeutics, Inc., with 268 participants planned, started 2023-07-17 and due to reach its primary completion in 2025-08. Interventions recorded: Navtemadlin, Navtemadlin Placebo. Conditions listed: Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05797831","url":"https://clinicaltrials.gov/study/NCT05797831"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["krt-232"],"companies":["kartos-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05797831","phase":"2/3","setting":"A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy","sponsor":"Kartos Therapeutics, Inc.","started":"2023-07-17","startedType":"actual","enrolled":268,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07011654","kind":"trial","name":"Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)","aka":[],"tldr":"A phase 1/2 trial of sacituzumab govitecan and naxitamab in triple-negative breast cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC) is a phase 1/2, interventional study registered as NCT07011654 by M.D. Anderson Cancer Center, with a registry enrolment figure of 31 participants, started 2025-09-19 and due to reach its primary completion in 2028-07-01. Interventions recorded: Sacituzumab govitecan; Naxitamab. Conditions listed: Metastatic Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* Histologically confirmed metastatic TNBC\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07011654","url":"https://clinicaltrials.gov/study/NCT07011654"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-govitecan","naxitamab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07011654","phase":"1/2","setting":"Phase I/II Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)","sponsor":"M.D. Anderson Cancer Center","started":"2025-09-19","startedType":"actual","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03476681","kind":"trial","name":"Study of NEO-201 in Solid Tumors Expansion Cohorts","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Precision Biologics, Inc, active and no longer recruiting.","summary":"Study of NEO-201 in Solid Tumors Expansion Cohorts is a phase 1/2 interventional study registered as NCT03476681 by Precision Biologics, Inc, with 121 participants planned, started 2019-01-18 and due to reach its primary completion in 2026-06-17. Interventions recorded: NEO-201 in combination with pembrolizumab. Conditions listed: Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Cervical Cancer, Uterine Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03476681","url":"https://clinicaltrials.gov/study/NCT03476681"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","head-and-neck","cervical"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03476681-j-exp-clin-cancer-res-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03476681","phase":"1/2","setting":"Phase 1/2 With Expansion Cohorts in a Study of NEO-201 in Adults With Chemo-Resistant Solid Tumors","sponsor":"Precision Biologics, Inc","started":"2019-01-18","startedType":"actual","enrolled":121,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05498155","kind":"trial","name":"Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer","aka":["OlympiaN"],"tldr":"A phase 2 trial of Olaparib and Durvalumab in advanced solid tumours, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer is a phase 2 interventional study registered as NCT05498155 by AstraZeneca, with 50 participants enrolled, started 2022-11-07 and due to reach its primary completion in 2024-11-20. Interventions recorded: Neoadjuvant Olaparib monotherapy group and Neoadjuvant combination therapy with olaparib plus durvalumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05498155","url":"https://clinicaltrials.gov/study/NCT05498155"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["olaparib","durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05498155","phase":"2","setting":"A Phase II, Multicentre, Open-Label Study to Assess the Efficacy and Safety of Olaparib Monotherapy and Olaparib Plus Durvalumab Combination as Neoadjuvant Therapy in Patients With BRCA Mutations and Early Stage HER2-Negative Breast Cancer","sponsor":"AstraZeneca","started":"2022-11-07","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03036098","kind":"trial","name":"Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer","aka":["CheckMate901"],"tldr":"A phase 3 trial of Nivolumab, Ipilimumab, Gemcitabine, Cisplatin and Carboplatin in bladder & urothelial cancer, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer is a phase 3 interventional study registered as NCT03036098 by Bristol-Myers Squibb, with 1314 participants enrolled, started 2017-03-24 and due to reach its primary completion in 2024-08-30. Interventions recorded: Nivolumab, Ipilimumab, Gemcitabine, Cisplatin and Carboplatin. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03036098","url":"https://clinicaltrials.gov/study/NCT03036098"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab","gemcitabine","cisplatin","carboplatin"],"companies":["bms","deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03036098","phase":"3","setting":"A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer","sponsor":"Bristol-Myers Squibb","started":"2017-03-24","startedType":"actual","yearReported":2025,"enrolled":1314,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study","primary":true,"unit":"months","arms":[{"name":"Treatment 1","n":221,"value":19.06,"note":"95% CI 13.47 to 22.60; Figures from the ClinicalTrials.gov results section (first posted 2025-09-18), not from a publication"},{"name":"Treatment 2","n":224,"value":13.21,"note":"95% CI 11.63 to 15.24"}],"hr":0.79,"ci":[0.64,0.97],"p":"0.0032","source":"https://clinicaltrials.gov/study/NCT03036098?tab=results"},{"endpoint":"Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Study","primary":true,"unit":"months","arms":[{"name":"Treatment 1","n":123,"value":16.3,"note":"95% CI 11.53 to 21.82; Figures from the ClinicalTrials.gov results section (first posted 2025-09-18), not from a publication"},{"name":"Treatment 2","n":127,"value":14.36,"note":"95% CI 10.48 to 17.64"}],"source":"https://clinicaltrials.gov/study/NCT03036098?tab=results"},{"endpoint":"Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-eligible Participants for Sub-study","primary":true,"unit":"months","arms":[{"name":"Treatment 3","n":304,"value":7.92,"note":"95% CI 7.62 to 9.49; Figures from the ClinicalTrials.gov results section (first posted 2025-09-18), not from a publication"},{"name":"Treatment 4","n":304,"value":7.56,"note":"95% CI 6.05 to 7.75"}],"hr":0.72,"ci":[0.59,0.88],"p":"0.0018","source":"https://clinicaltrials.gov/study/NCT03036098?tab=results"}]},{"id":"nct05775159","kind":"trial","name":"Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer","aka":["GEMINI-Hepatobiliary"],"tldr":"A phase 2 trial of Bevacizumab, Lenvatinib, Rilvegostomig in hepatocellular carcinoma, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer is a phase 2 interventional study registered as NCT05775159 by AstraZeneca, with 294 participants planned, started 2023-04-24 and due to reach its primary completion in 2026-10-27. Interventions recorded: Volrustomig, Bevacizumab, Lenvatinib, Rilvegostomig, Gemcitabine. Conditions listed: Hepatocellular Carcinoma, Biliary Tract Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05775159","url":"https://clinicaltrials.gov/study/NCT05775159"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab","lenvatinib","rilvegostomig","gemcitabine","cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05775159","phase":"2","setting":"A Phase II, Open-Label, Multi-Drug, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary)","sponsor":"AstraZeneca","started":"2023-04-24","startedType":"actual","enrolled":294,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06727565","kind":"trial","name":"Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Subst","aka":["VELOCITY-HNSCC"],"tldr":"A phase 2 trial of Domvanalimab, Zimberelimab, Paclitaxel / nab-paclitaxel in head and neck squamous cell carcinoma, run by Gilead Sciences, active and no longer recruiting.","summary":"Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01 is a phase 2 interventional study registered as NCT06727565 by Gilead Sciences, with 39 participants enrolled, started 2025-02-18 and due to reach its primary completion in 2027-03. Interventions recorded: Domvanalimab, Zimberelimab, Paclitaxel, Carboplatin. Conditions listed: Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06727565","url":"https://clinicaltrials.gov/study/NCT06727565"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["domvanalimab","zimberelimab","paclitaxel","carboplatin"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06727565","phase":"2","setting":"VELOCITY-HNSCC Substudy-01: A Phase 2 Study of Novel Combination Therapies in Participants With Previously Untreated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status","sponsor":"Gilead Sciences","started":"2025-02-18","startedType":"actual","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05633667","kind":"trial","name":"Study of Novel Treatment Combinations in Patients With Lung Cancer","aka":["VELOCITY-Lung"],"tldr":"A phase 2 trial of Zimberelimab, Domvanalimab, Sacituzumab govitecan in non-small-cell lung cancer and small-cell lung cancer, run by Gilead Sciences, active and no longer recruiting.","summary":"Study of Novel Treatment Combinations in Patients With Lung Cancer is a phase 2 interventional study registered as NCT05633667 by Gilead Sciences, with 192 participants enrolled, started 2023-03-16 and due to reach its primary completion in 2029-09. Interventions recorded: Zimberelimab (ZIM), Domvanalimab (DOM), Sacituzumab govitecan-hziy (SG), Etrumadenant (ETRUMA), Carboplatin. Conditions listed: Lung Cancer, Advanced or Metastatic Non-Small-Cell Lung Cancer, Resectable Non-Small-Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05633667","url":"https://clinicaltrials.gov/study/NCT05633667"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["zimberelimab","domvanalimab","sacituzumab-govitecan","carboplatin","cisplatin","pemetrexed"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05633667","phase":"2","setting":"A Phase 2 Platform Study Evaluating the Safety and Efficacy of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)","sponsor":"Gilead Sciences","started":"2023-03-16","startedType":"actual","enrolled":192,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07520006","kind":"trial","name":"Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies","aka":[],"tldr":"A phase 1/2 trial of Bexobrutideg, Venetoclax, Rituximab and Obinutuzumab in non-Hodgkin lymphoma and chronic lymphocytic leukaemia, run by Nurix Therapeutics, Inc., now recruiting.","summary":"Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies is a phase 1/2 interventional study registered as NCT07520006 by Nurix Therapeutics, Inc., with 150 participants planned, started 2026-08 and due to reach its primary completion in 2033-05. Interventions recorded: NX-5948, venetoclax, rituximab and obinutuzumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07520006","url":"https://clinicaltrials.gov/study/NCT07520006"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","cll"],"sections":[],"technologies":[],"targets":[],"drugs":["bexobrutideg","venetoclax","rituximab","obinutuzumab"],"companies":["nurix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07520006","phase":"1/2","setting":"An Open-label, Multicenter Phase 1b/2 Study to Evaluate the Safety and Efficacy of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies","sponsor":"Nurix Therapeutics, Inc.","started":"2026-08","startedType":"estimated","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07516093","kind":"trial","name":"Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL","aka":[],"tldr":"A phase 3 trial testing Bexobrutideg in chronic lymphocytic leukaemia, now recruiting.","summary":"Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL is a phase 3 interventional study registered as NCT07516093, led by Nurix Therapeutics, and recruiting on the registry. Official title: A Phase 3, Randomised, Open-label, Multicenter Study of NX-5948 Versus Pirtobrutinib in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukaemia (CLL)/Small Lymphocytic Lymphoma (SLL). Planned enrolment is 620 participants (estimated). The study started in 2026-08-03 and primary completion is expected in 2029-10. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07516093","url":"https://clinicaltrials.gov/study/NCT07516093"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":[],"targets":[],"drugs":["bexobrutideg"],"companies":["nurix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07516093","phase":"3","setting":"A Phase 3, Randomized, Open-label, Multicenter Study of NX-5948 Versus Pirtobrutinib in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)","sponsor":"Nurix Therapeutics","started":"2026-08-03","startedType":"actual","enrolled":620,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06616389","kind":"trial","name":"Study of ODX (OsteoDex) in Multiple Myeloma","aka":[],"tldr":"A phase 1/2 trial of ODX (Osteodex) in multiple myeloma, run by DexTech Medical AB, now recruiting.","summary":"Study of ODX (OsteoDex) in Multiple Myeloma is a phase 1/2 interventional study registered as NCT06616389 by DexTech Medical AB, with 12 participants planned, started 2023-11-29 and due to reach its primary completion in 2026-01-30. Interventions recorded: ODX (Osteodex).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06616389","url":"https://clinicaltrials.gov/study/NCT06616389"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06616389","phase":"1/2","setting":"A Phase I/IIa Study of ODX (OsteoDex) in Multiple Myeloma","sponsor":"DexTech Medical AB","started":"2023-11-29","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06890598","kind":"trial","name":"Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer","aka":["SUNRAY-02"],"tldr":"A phase 3 trial of Olomorasib, Pembrolizumab and Durvalumab in non-small-cell lung cancer, run by Eli Lilly and Company, now recruiting.","summary":"Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06890598 by Eli Lilly and Company, with 700 participants planned, started 2025-03-27 and due to reach its primary completion in 2029-05. Interventions recorded: Olomorasib, Pembrolizumab, Durvalumab and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06890598","url":"https://clinicaltrials.gov/study/NCT06890598"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["olomorasib","pembrolizumab","durvalumab"],"companies":["eli-lilly","astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06890598","phase":"3","setting":"A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02","sponsor":"Eli Lilly and Company","started":"2025-03-27","startedType":"actual","enrolled":700,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06161974","kind":"trial","name":"Study of Olutasidenib and Temozolomide in HGG","aka":[],"tldr":"A phase 2 trial of Olutasidenib in diffuse midline glioma, h3 k27-altered, run by Rigel Pharmaceuticals, now recruiting.","summary":"Study of Olutasidenib and Temozolomide in HGG is a phase 2 interventional study registered as NCT06161974 by Rigel Pharmaceuticals, with 60 participants planned, started 2025-02-01 and due to reach its primary completion in 2029-06. Interventions recorded: Olutasidenib + TMZ. Conditions listed: High Grade Glioma, Astrocytoma, Astrocytoma, Grade III, Astrocytoma, Grade IV. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06161974","url":"https://clinicaltrials.gov/study/NCT06161974"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dipg-dmg"],"sections":[],"technologies":["epigenetic-drugs","idh-inhibitors"],"targets":[],"drugs":["olutasidenib"],"companies":["rigel-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06161974","phase":"2","setting":"Phase 2 Study of Olutasidenib With Temozolomide as Maintenance Therapy in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor IDH1 Mutations","sponsor":"Rigel Pharmaceuticals","started":"2025-02-01","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06423911","kind":"trial","name":"Study of Olverembatinib (HQP1351) in Patients With CML-CP","aka":["POLARIS-2"],"tldr":"A phase 3 trial of Olverembatinib run by Ascentage Pharma Group Inc., now recruiting.","summary":"Study of Olverembatinib (HQP1351) in Patients With CML-CP is a phase 3 interventional study registered as NCT06423911 by Ascentage Pharma Group Inc., with 333 participants planned, started 2024-02-05. Conditions listed: Chronic Myeloid Leukemia, CML, CML, Chronic Phase. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06423911","url":"https://clinicaltrials.gov/study/NCT06423911"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cml","cml-chronic-phase"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["olverembatinib"],"companies":["ascentage-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06423911","phase":"3","setting":"A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)","sponsor":"Ascentage Pharma Group Inc.","started":"2024-02-05","startedType":"actual","enrolled":333,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07282587","kind":"trial","name":"Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma","aka":[],"tldr":"A phase 2 trial of ONC206 in pheochromocytoma and paraganglioma, run by Jazz Pharmaceuticals, now recruiting.","summary":"Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma is a phase 2 interventional study registered as NCT07282587 by Jazz Pharmaceuticals, with 90 participants planned, started 2026-01-02 and due to reach its primary completion in 2028-12-15. Interventions recorded: ONC206, ONC206: Dose 1 and ONC206: Dose 2.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07282587","url":"https://clinicaltrials.gov/study/NCT07282587"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pheochromocytoma-paraganglioma","metastatic-ppgl"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["jazz"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07282587","phase":"2","setting":"A Phase 2 Study of ONC206 in Advanced Pheochromocytoma and Paraganglioma","sponsor":"Jazz Pharmaceuticals","started":"2026-01-02","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06106308","kind":"trial","name":"Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab fo","aka":[],"tldr":"A phase 2 trial of FOLFIRI, Bevacizumab, FOLFOX in colorectal cancer, run by Cardiff Oncology, active and no longer recruiting.","summary":"Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer in Adult Participants With a KRAS or NRAS Mutation is a phase 2 interventional study registered as NCT06106308 by Cardiff Oncology, with 110 participants enrolled, started 2024-02-27 and due to reach its primary completion in 2026-11. Interventions recorded: Onvansertib, FOLFIRI, Bevacizumab, FOLFOX. Conditions listed: Metastatic Colorectal Cancer, CRC, KRAS/NRAS Mutation. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06106308","url":"https://clinicaltrials.gov/study/NCT06106308"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["folfiri","bevacizumab","folfox","onvansertib"],"companies":["cardiff-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct06106308-j-clin-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06106308","phase":"2","setting":"A Phase 2, Randomized, Open-label Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients With a KRAS or NRAS Mutation","sponsor":"Cardiff Oncology","started":"2024-02-27","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06136624","kind":"trial","name":"Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)","aka":["OMAHA-003"],"tldr":"A phase 3 trial testing Opevesostat in prostate cancer, now recruiting.","summary":"Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) is a phase 3 interventional study registered as NCT06136624, led by Merck Sharp & Dohme, and recruiting on the registry. Official title: A Phase 3 Randomised, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003). Planned enrolment is 1310 participants (estimated). The study started in 2023-12-31 and primary completion is expected in 2028-08-02. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06136624","url":"https://clinicaltrials.gov/study/NCT06136624"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["opevesostat"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06136624","phase":"3","setting":"A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)","sponsor":"Merck Sharp & Dohme","started":"2023-12-31","startedType":"actual","enrolled":1310,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07079475","kind":"trial","name":"Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)","aka":["TIAN-SHAN8"],"tldr":"A phase 1/2 trial of Sunvozertinib, Osimertinib in non-small-cell lung cancer and small-cell lung cancer, run by Dizal Pharmaceuticals, now recruiting.","summary":"Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8) is a phase 1/2 interventional study registered as NCT07079475 by Dizal Pharmaceuticals, with 220 participants planned, started 2025-07-30 and due to reach its primary completion in 2028-06. Interventions recorded: DZD6008, Sunvozertinib, Osimertinib. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07079475","url":"https://clinicaltrials.gov/study/NCT07079475"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["sunvozertinib","osimertinib"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07079475","phase":"1/2","setting":"A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combined With Sunvozertinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN8)","sponsor":"Dizal Pharmaceuticals","started":"2025-07-30","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05546268","kind":"trial","name":"Study of Oral MRT-2359 in Selected Cancer Patients","aka":[],"tldr":"A phase 1/2 trial of Oral MRT-2359 in non-small-cell lung cancer, small-cell lung cancer, neuroendocrine tumours, HR-positive / HER2-negative breast cancer and prostate cancer, run by Monte Rosa Therapeutics, Inc, active and no longer recruiting.","summary":"Study of Oral MRT-2359 in Selected Cancer Patients is a phase 1/2 interventional study registered as NCT05546268 by Monte Rosa Therapeutics, Inc, with 174 participants enrolled, started 2022-10-12 and due to reach its primary completion in 2026-05. Interventions recorded: Oral MRT-2359.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05546268","url":"https://clinicaltrials.gov/study/NCT05546268"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","neuroendocrine","breast-hr-positive","prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["monte-rosa"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05546268","phase":"1/2","setting":"A Phase 1/2 Study of Oral MRT-2359 in Patients With MYC-Driven and Other Selected Solid Tumors Including Lung Cancer and Diffuse B-Cell Lymphoma","sponsor":"Monte Rosa Therapeutics, Inc","started":"2022-10-12","startedType":"actual","enrolled":174,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07745361","kind":"trial","name":"Study of Oral MRT-2359 With Apalutamide in Prostate Cancer","aka":["MODeFIRe-1"],"tldr":"A phase 2 trial of Apalutamide in prostate cancer, run by Monte Rosa Therapeutics, Inc, now recruiting.","summary":"Study of Oral MRT-2359 With Apalutamide in Prostate Cancer is a phase 2 interventional study registered as NCT07745361 by Monte Rosa Therapeutics, Inc, with 25 participants planned, started 2026-08 and due to reach its primary completion in 2027-10. Interventions recorded: Oral MRT-2359, Apalutamide. Conditions listed: Castration-Resistant Prostate Cancer (CRPC), Castration-Resistant Prostate Cancer, Prostate Cancer, Prostate Cancer (Adenocarcinoma). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07745361","url":"https://clinicaltrials.gov/study/NCT07745361"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["apalutamide"],"companies":["monte-rosa"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07745361","phase":"2","setting":"MODeFIRe-1 (Molecular Degrader for Inhibitor Resistance): A Phase 2, Open-Label, Multicenter Study of Oral MRT-2359 in Combination With Apalutamide in Patients With Castration-Resistant Prostate Cancer","sponsor":"Monte Rosa Therapeutics, Inc","started":"2026-08","startedType":"estimated","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04468984","kind":"trial","name":"Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis","aka":["TRANSFORM-2"],"tldr":"A phase 3 trial testing Navitoclax in myeloproliferative neoplasms, active and no longer recruiting.","summary":"Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis is a phase 3 interventional study registered as NCT04468984, led by AbbVie, and active but no longer recruiting on the registry. Official title: Randomised, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination With Ruxolitinib Versus Best Available Therapy in Subjects With Relapsed/Refractory Myelofibrosis (TRANSFORM-2), Incorporating Extension Arm C - Continued Access for Navitoclax to Roll Over Subjects From Studies M10-166, M16-109, M16-191, and M19-753. Planned enrolment is 330 participants (estimated). The study started in 2020-08-31 and primary completion is expected in 2025-01-29. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04468984","url":"https://clinicaltrials.gov/study/NCT04468984"}],"tags":["ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","primary-myelofibrosis"],"sections":[],"technologies":[],"targets":[],"drugs":["navitoclax"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04468984","phase":"3","setting":"Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination With Ruxolitinib Versus Best Available Therapy in Subjects With Relapsed/Refractory Myelofibrosis (TRANSFORM-2), Incorporating Extension Arm C - Continued Access for Navitoclax to Roll Over Subjects From Studies M10-166, M16-109, M16-191, and M19-753","sponsor":"AbbVie","started":"2020-08-31","startedType":"actual","enrolled":330,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05287945","kind":"trial","name":"Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma","aka":[],"tldr":"A phase 1/2 trial of Orellanine in renal cell carcinoma, run by Oncorena AB, now recruiting.","summary":"Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma is a phase 1/2 interventional study registered as NCT05287945 by Oncorena AB, with 75 participants planned, started 2023-08-04 and due to reach its primary completion in 2027-12-31. Interventions recorded: Orellanine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05287945","url":"https://clinicaltrials.gov/study/NCT05287945"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc","clear-cell-rcc","papillary-rcc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05287945","phase":"1/2","setting":"A Phase I/II, Open-Label, Single-Arm Study on Safety, Tolerability and Anti-Tumour Efficacy of Orellanine Treatment in Patients With Metastatic Clear-Cell or Papillary Renal Cell Carcinoma","sponsor":"Oncorena AB","started":"2023-08-04","startedType":"actual","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05315700","kind":"trial","name":"Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration","aka":[],"tldr":"A phase 1/2 trial of ORIC-114 in advanced solid tumours, run by ORIC Pharmaceuticals, now recruiting.","summary":"Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration is a phase 1/2 interventional study registered as NCT05315700 by ORIC Pharmaceuticals, with 350 participants planned, started 2022-03-10 and due to reach its primary completion in 2026-09. Interventions recorded: ORIC-114 and Chemotherapy drug.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05315700","url":"https://clinicaltrials.gov/study/NCT05315700"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["oric-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05315700","phase":"1/2","setting":"An Open-Label, Phase 1/2 Study of ORIC-114 as a Single Agent or in Combination With Chemotherapy, in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration","sponsor":"ORIC Pharmaceuticals","started":"2022-03-10","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04094311","kind":"trial","name":"Study of Out of Specification for Tisagenlecleucel","aka":[],"tldr":"A phase 3 trial of Tisagenlecleucel in diffuse large b-cell lymphoma, run by Novartis Pharmaceuticals, now recruiting.","summary":"Study of Out of Specification for Tisagenlecleucel is a phase 3 interventional study registered as NCT04094311 by Novartis Pharmaceuticals, with 200 participants planned, started 2019-11-21 and due to reach its primary completion in 2027-03-31. Interventions recorded: CTL019. Conditions listed: B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04094311","url":"https://clinicaltrials.gov/study/NCT04094311"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["tisagenlecleucel"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04094311","phase":"3","setting":"A Phase IIIb Study of the Safety and Efficacy of Tisagenlecleucel Out of Specification for Commercial Release in Patients Who Are Consistent With the Label Indication","sponsor":"Novartis Pharmaceuticals","started":"2019-11-21","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03709680","kind":"trial","name":"Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors","aka":[],"tldr":"A phase 2 trial of Palbociclib, Temozolomide, FOLFIRI in ewing sarcoma and rhabdomyosarcoma, run by Pfizer, active and no longer recruiting.","summary":"Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors is a phase 2 interventional study registered as NCT03709680 by Pfizer, with 128 participants enrolled, started 2019-05-24 and due to reach its primary completion in 2024-08-26. Interventions recorded: Palbociclib, Temozolomide, Irinotecan, Topotecan, Cyclophosphamide. Conditions listed: Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03709680","url":"https://clinicaltrials.gov/study/NCT03709680"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ewing-sarcoma","rhabdomyosarcoma","medulloblastoma","dipg-dmg"],"sections":[],"technologies":["cdk46-inhibitor","cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["palbociclib","temozolomide","folfiri","topotecan","cyclophosphamide"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03709680","phase":"2","setting":"PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE®) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS","sponsor":"Pfizer","started":"2019-05-24","startedType":"actual","enrolled":128,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06596694","kind":"trial","name":"Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)","aka":["HERTHENA-PanTumor02"],"tldr":"A phase 1/2 trial of Patritumab deruxtecan in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02) is a phase 1/2 interventional study registered as NCT06596694 by Merck Sharp & Dohme LLC, with 180 participants planned, started 2024-11-03 and due to reach its primary completion in 2028-12-07. Interventions recorded: Patritumab deruxtecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06596694","url":"https://clinicaltrials.gov/study/NCT06596694"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["patritumab-deruxtecan"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06596694","phase":"1/2","setting":"A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers","sponsor":"Merck Sharp & Dohme LLC","started":"2024-11-03","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06797635","kind":"trial","name":"Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)","aka":["HERTHENA-Breast03"],"tldr":"A phase 2 trial of Patritumab deruxtecan, Pembrolizumab, Carboplatin, Doxorubicin, Epirubicin and Cyclophosphamide in HR-positive / HER2-negative breast cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03) is a phase 2 interventional study registered as NCT06797635 by Merck Sharp & Dohme LLC, with 372 participants planned, started 2025-03-20 and due to reach its primary completion in 2029-12-31. Interventions recorded: Patritumab deruxtecan, Pembrolizumab, Paclitaxel, Carboplatin, Doxorubicin hydrochloride and Epirubicin hydrochloride.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06797635","url":"https://clinicaltrials.gov/study/NCT06797635"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["adc","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["patritumab-deruxtecan","pembrolizumab","carboplatin","doxorubicin","epirubicin","cyclophosphamide"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06797635","phase":"2","setting":"An Open-label Randomized Phase 2 Study to Evaluate Safety and Efficacy of Patritumab Deruxtecan Plus Pembrolizumab Administered Either Before or After Carboplatin/Paclitaxel Plus Pembrolizumab Compared With Pembrolizumab in Combination With Chemotherapy Followed by Surgery and Adjuvant Pembrolizumab for High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer (HERTHENA-Breast03)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-03-20","startedType":"actual","enrolled":372,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06686394","kind":"trial","name":"Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)","aka":["HERTHENA-Breast-01"],"tldr":"A phase 1/2 trial of Patritumab deruxtecan, Trastuzumab, Pertuzumab and Tucatinib in HER2-positive breast cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) is a phase 1/2 interventional study registered as NCT06686394 by Merck Sharp & Dohme LLC, with 81 participants planned, started 2025-02-26 and due to reach its primary completion in 2030-04-18. Interventions recorded: Patritumab deruxtecan, Trastuzumab, Trastuzumab Biosimilar, Pertuzumab and Tucatinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06686394","url":"https://clinicaltrials.gov/study/NCT06686394"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["patritumab-deruxtecan","trastuzumab","pertuzumab","tucatinib"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06686394","phase":"1/2","setting":"HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer","sponsor":"Merck Sharp & Dohme LLC","started":"2025-02-26","startedType":"actual","enrolled":81,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02861573","kind":"trial","name":"Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)","aka":["KEYNOTE-365"],"tldr":"A phase 1/2 trial of Pembrolizumab, Olaparib, Docetaxel in prostate cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365) is a phase 1/2 interventional study registered as NCT02861573 by Merck Sharp & Dohme LLC, with 1200 participants planned, started 2016-11-17 and due to reach its primary completion in 2027-10-22. Interventions recorded: Pembrolizumab 200 mg, Olaparib 400 mg, Docetaxel 75 mg/m^2, Prednisone 5 mg, Enzalutamide 160 mg. Conditions listed: Metastatic Castration-Resistant Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02861573","url":"https://clinicaltrials.gov/study/NCT02861573"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","olaparib","docetaxel","enzalutamide","abiraterone","lenvatinib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02861573-eur-urol-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02861573","phase":"1/2","setting":"Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)","sponsor":"Merck Sharp & Dohme LLC","started":"2016-11-17","startedType":"actual","enrolled":1200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04634877","kind":"trial","name":"Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)","aka":["KEYNOTE-B21"],"tldr":"A phase 3 trial of Pembrolizumab, Carboplatin, Docetaxel and Cisplatin in endometrial cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) is a phase 3 interventional study registered as NCT04634877 by Merck Sharp & Dohme LLC, with 990 participants enrolled, started 2021-01-10 and due to reach its primary completion in 2026-09-15. Interventions recorded: Pembrolizumab, Carboplatin, Paclitaxel, Placebo for pembrolizumab, Docetaxel and Cisplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04634877","url":"https://clinicaltrials.gov/study/NCT04634877"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","carboplatin","docetaxel","cisplatin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04634877","phase":"3","setting":"A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)","sponsor":"Merck Sharp & Dohme LLC","started":"2021-01-10","startedType":"actual","enrolled":990,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05609968","kind":"trial","name":"Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)","aka":["EVOKE-03"],"tldr":"A phase 3 trial of Sacituzumab govitecan and Pembrolizumab in non-small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46) is a phase 3 interventional study registered as NCT05609968 by Merck Sharp & Dohme LLC, with 614 participants enrolled, started 2023-02-06 and due to reach its primary completion in 2027-01-12. Interventions recorded: Sacituzumab Govitecan and Pembrolizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05609968","url":"https://clinicaltrials.gov/study/NCT05609968"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan","pembrolizumab"],"companies":["merck","gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05609968","phase":"3","setting":"An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator-Controlled Clinical Study of Pembrolizumab (MK-3475) in Combination With Sacituzumab Govitecan Versus MK-3475 Monotherapy as First-line Treatment in Participants With PD L1 TPS Greater Than or Equal to 50% Metastatic Non-small Cell Lung Cancer (KEYNOTE D46/EVOKE-03)","sponsor":"Merck Sharp & Dohme LLC","started":"2023-02-06","startedType":"actual","enrolled":614,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04895358","kind":"trial","name":"Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)","aka":["KEYNOTE-B49"],"tldr":"A phase 3 trial of Pembrolizumab, Doxorubicin and Capecitabine in advanced solid tumours, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) is a phase 3 interventional study registered as NCT04895358 by Merck Sharp & Dohme LLC, with 342 participants enrolled, started 2021-06-18 and due to reach its primary completion in 2026-04-24. Interventions recorded: pembrolizumab, paclitaxel, nab-paclitaxel, liposomal doxorubicin, capecitabine and normal saline.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04895358","url":"https://clinicaltrials.gov/study/NCT04895358"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","doxorubicin","capecitabine"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04895358","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)","sponsor":"Merck Sharp & Dohme LLC","started":"2021-06-18","startedType":"actual","enrolled":342,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04956692","kind":"trial","name":"Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participan","aka":[],"tldr":"A phase 3 trial of Pembrolizumab, Paclitaxel / nab-paclitaxel, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86) is a phase 3 interventional study registered as NCT04956692 by Merck Sharp & Dohme LLC, with 531 participants enrolled, started 2021-08-05 and due to reach its primary completion in 2023-04-04. Interventions recorded: Pembrolizumab SC, Pembrolizumab IV, Paclitaxel, Nab-Paclitaxel, Carboplatin. Conditions listed: Non-Small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2024; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04956692","url":"https://clinicaltrials.gov/study/NCT04956692"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","paclitaxel","carboplatin","cisplatin","pemetrexed"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04956692","phase":"3","setting":"A Randomized, Phase 3, Open-label Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab, Administered With Platinum Doublet Chemotherapy, in the First-Line Treatment of Participants With Metastatic Squamous or Nonsquamous Non-Small-Cell Lung Cancer","sponsor":"Merck Sharp & Dohme LLC","started":"2021-08-05","startedType":"actual","yearReported":2024,"enrolled":531,"enrolledBasis":"registry","outcomes":[{"endpoint":"Cycle 1 Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab","primary":true,"unit":"hr*µg/ml","arms":[{"name":"Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy","n":355,"value":471.33,"note":"95% CI 452.22 to 491.26; Figures from the ClinicalTrials.gov results section (first posted 2024-05-17), not from a publication"},{"name":"Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy","n":170,"value":454.96,"note":"95% CI 438.54 to 471.99"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT04956692?tab=results"}]},{"id":"nct05239741","kind":"trial","name":"Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)","aka":[],"tldr":"A phase 3 trial of Pembrolizumab, Oxaliplatin, Bevacizumab and Cetuximab in colorectal cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66) is a phase 3 interventional study registered as NCT05239741 by Merck Sharp & Dohme LLC, with 100 participants enrolled, started 2022-04-02 and due to reach its primary completion in 2028-09-19. Interventions recorded: Pembrolizumab, Oxaliplatin, Leucovorin, 5-fluorouracil, Irinotecan and Bevacizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05239741","url":"https://clinicaltrials.gov/study/NCT05239741"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","oxaliplatin","bevacizumab","cetuximab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05239741","phase":"3","setting":"A Phase 3 Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer (MK-3475-C66)","sponsor":"Merck Sharp & Dohme LLC","started":"2022-04-02","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05173987","kind":"trial","name":"Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)","aka":["KEYNOTE-C93"],"tldr":"A phase 3 trial of Pembrolizumab, Carboplatin, Docetaxel and Cisplatin in endometrial cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) is a phase 3 interventional study registered as NCT05173987 by Merck Sharp & Dohme LLC, with 280 participants enrolled, started 2022-02-03 and due to reach its primary completion in 2027-05-27. Interventions recorded: pembrolizumab, carboplatin, paclitaxel, docetaxel and cisplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05173987","url":"https://clinicaltrials.gov/study/NCT05173987"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer","endometrial-mmr-deficient"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","carboplatin","docetaxel","cisplatin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05173987","phase":"3","setting":"A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab Versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)","sponsor":"Merck Sharp & Dohme LLC","started":"2022-02-03","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02362594","kind":"trial","name":"Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)","aka":["KEYNOTE-054"],"tldr":"A phase 3 trial of Pembrolizumab in melanoma, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054) is a phase 3 interventional study registered as NCT02362594 by Merck Sharp & Dohme LLC, with 1019 participants enrolled, started 2015-07-16 and due to reach its primary completion in 2018-01-08. Interventions recorded: pembrolizumab, placebo. Conditions listed: Melanoma. Results were posted on ClinicalTrials.gov in 2019; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02362594","url":"https://clinicaltrials.gov/study/NCT02362594"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","stage-iii-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-keynote-054-eggermont-nejm-2018","paper-nct02362594-lancet-oncol-2021-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02362594","phase":"3","setting":"Adjuvant Immunotherapy With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-risk Stage III Melanoma: A Randomized, Double- Blind Phase 3 Trial of the EORTC Melanoma Group","sponsor":"Merck Sharp & Dohme LLC","started":"2015-07-16","startedType":"actual","yearReported":2019,"enrolled":1019,"enrolledBasis":"registry","outcomes":[{"endpoint":"Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":514,"value":82.2,"note":"95% CI 78.6 to 85.3; Figures from the ClinicalTrials.gov results section (first posted 2019-01-04), not from a publication"},{"name":"Placebo","n":505,"value":73.3,"note":"95% CI 69.2 to 77.0"}],"hr":0.57,"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT02362594?tab=results"},{"endpoint":"Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":428,"value":83.8,"note":"95% CI 80.0 to 87.0; Figures from the ClinicalTrials.gov results section (first posted 2019-01-04), not from a publication"},{"name":"Placebo","n":425,"value":75.4,"note":"95% CI 71.0 to 79.2"}],"hr":0.54,"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT02362594?tab=results"}]},{"id":"nct03725059","kind":"trial","name":"Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)","aka":["KEYNOTE-756"],"tldr":"A phase 3 trial of Pembrolizumab, Doxorubicin, Epirubicin and Cyclophosphamide in HR-positive / HER2-negative breast cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756) is a phase 3 interventional study registered as NCT03725059 by Merck Sharp & Dohme LLC, with 1240 participants enrolled, started 2018-12-27 and due to reach its primary completion in 2031-01-24. Interventions recorded: Pembrolizumab (K), Placebo (P), Paclitaxel (X), Doxorubicin (A), Epirubicin (E) and Cyclophosphamide (C).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03725059","url":"https://clinicaltrials.gov/study/NCT03725059"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","doxorubicin","epirubicin","cyclophosphamide"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03725059-nat-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03725059","phase":"3","setting":"A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (KEYNOTE-756)","sponsor":"Merck Sharp & Dohme LLC","started":"2018-12-27","startedType":"actual","enrolled":1240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07777822","kind":"trial","name":"Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mu","aka":["RASolve 308"],"tldr":"A phase 3 trial of Zoldonrasib, Pembrolizumab, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by Revolution Medicines, Inc., now recruiting.","summary":"Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC is a phase 3 interventional study registered as NCT07777822 by Revolution Medicines, Inc., with 430 participants planned, started 2026-08-14 and due to reach its primary completion in 2029-10. Interventions recorded: zoldonrasib, Placebo, pembrolizumab, pemetrexed + cisplatin /carboplatin. Conditions listed: NSCLC, Non-small Cell Lung Cancer, Non-Small Cell Lung Cancer NSCLC, Non-Squamous Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07777822","url":"https://clinicaltrials.gov/study/NCT07777822"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","kras-inhibitors"],"targets":[],"drugs":["zoldonrasib","pembrolizumab","pemetrexed","cisplatin","carboplatin"],"companies":["revolution-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07777822","phase":"3","setting":"A Randomized, Double-blind, Phase 3 Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib (RMC-9805) as First Line Treatment in Patients With Metastatic Non-squamous RAS G12D-Mutated Non-small Cell Lung Cancer (RASolve 308)","sponsor":"Revolution Medicines, Inc.","started":"2026-08-14","startedType":"actual","enrolled":430,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04380636","kind":"trial","name":"Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)","aka":["KEYLYNK-012"],"tldr":"A phase 3 trial of Pembrolizumab, Olaparib, Etoposide, Carboplatin, Cisplatin and Pemetrexed in non-small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) is a phase 3 interventional study registered as NCT04380636 by Merck Sharp & Dohme LLC, with 870 participants enrolled, started 2020-07-06 and due to reach its primary completion in 2027-05-05. Interventions recorded: Pembrolizumab, Olaparib, Placebo for olaparib, Etoposide, Carboplatin and Cisplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04380636","url":"https://clinicaltrials.gov/study/NCT04380636"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["pembrolizumab","olaparib","etoposide","carboplatin","cisplatin","pemetrexed"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04380636","phase":"3","setting":"A Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Merck Sharp & Dohme LLC","started":"2020-07-06","startedType":"actual","enrolled":870,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04786964","kind":"trial","name":"Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab in First Line Metastatic Non-squamous NSCLC","aka":[],"tldr":"A phase 3 trial of Cosibelimab, Cisplatin, Carboplatin and Pemetrexed in Non-small-cell lung cancer, run by Checkpoint Therapeutics, Inc., recorded as terminated on the registry.","summary":"Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab in First Line Metastatic Non-squamous NSCLC is a phase 3 interventional study registered as NCT04786964 by Checkpoint Therapeutics, Inc., with 25 participants recorded, started 2021-12-08 and due to reach its primary completion in 2023-12-30. Interventions recorded: Cosibelimab, Cisplatin, Carboplatin, Pemetrexed, Folic acid 350-1000 μg, Vitamin B12 1000 μg, Dexamethasone 4mg. Conditions recorded: Metastatic Non-squamous Non Small Cell Lung Cancer.\n\nLinked to the drug Cosibelimab because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04786964","url":"https://clinicaltrials.gov/study/NCT04786964"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["cosibelimab","cisplatin","carboplatin","pemetrexed"],"companies":["checkpoint-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04786964","phase":"3","setting":"A Randomized, Open-Label, Phase 3 Study of Cosibelimab (CK-301) in Combination With Platinum+Pemetrexed Chemotherapy in Subjects With First-Line Metastatic Non-squamous Non-Small Cell Lung Cancer","sponsor":"Checkpoint Therapeutics, Inc.","started":"2021-12-08","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05855200","kind":"trial","name":"Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer","aka":["AZUR-2"],"tldr":"A phase 3 trial of Dostarlimab in colorectal cancer, run by GlaxoSmithKline, now recruiting.","summary":"Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer is a phase 3 interventional study registered as NCT05855200 by GlaxoSmithKline, with 892 participants planned, started 2023-08-01 and due to reach its primary completion in 2029-03-19. Interventions recorded: Dostarlimab, CAPEOX and FOLFOX.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05855200","url":"https://clinicaltrials.gov/study/NCT05855200"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","msi-high-colorectal","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["dostarlimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":["niche-2","azur-1","atomic"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["AZUR-2 is the phase 3 test of perioperative dostarlimab in untreated T4N0 or stage III mismatch-repair deficient, MSI-high resectable colon cancer, against surgery with standard adjuvant chemotherapy. The registry lists 892 participants, a start date of 1 August 2023, recruitment continuing and primary completion due 19 March 2029. It is the trial that would turn the NICHE-2 pathological complete response rate into a change in the standard of care."],"nct":"NCT05855200","phase":"3","setting":"A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer","sponsor":"GlaxoSmithKline","started":"2023-08-01","startedType":"actual","enrolled":892,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07775287","kind":"trial","name":"Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metast","aka":[],"tldr":"A phase 3 trial of Petosemtamab, Cetuximab, Bevacizumab in colorectal cancer, run by Genmab, now recruiting.","summary":"Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metastatic Colorectal Cancer (LiGeR-CRC2) is a phase 3 interventional study registered as NCT07775287 by Genmab, with 600 participants planned, started 2026-09-15 and due to reach its primary completion in 2029-03-30. Interventions recorded: Petosemtamab, Cetuximab, Bevacizumab, 5-FU, Leucovorin (Calcium Folinate). Conditions listed: Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07775287","url":"https://clinicaltrials.gov/study/NCT07775287"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","bispecific-antibody","monoclonal-antibody"],"targets":[],"drugs":["petosemtamab","cetuximab","bevacizumab","flot","fluorouracil","leucovorin"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07775287","phase":"3","setting":"A Randomized, Open-label, Phase 3 Trial of Petosemtamab + FOLFIRI/mFOLFOX6 Versus Cetuximab or Bevacizumab + FOLFIRI/mFOLFOX6 as Second-line Treatment in Participants With RAS and BRAF Wild-type, Recurrent, Unresectable or Metastatic Colorectal Cancer","sponsor":"Genmab","started":"2026-09-15","startedType":"estimated","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07702032","kind":"trial","name":"Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorecta","aka":[],"tldr":"A phase 3 trial of Petosemtamab, Cetuximab, FOLFIRI in colorectal cancer, run by Genmab, now recruiting.","summary":"Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1) is a phase 3 interventional study registered as NCT07702032 by Genmab, with 960 participants planned, started 2026-08-11 and due to reach its primary completion in 2029-07. Interventions recorded: Petosemtamab, Cetuximab, FOLFIRI, mFOLFOX6. Conditions listed: Left-sided Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07702032","url":"https://clinicaltrials.gov/study/NCT07702032"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["bispecific-antibody","cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["petosemtamab","cetuximab","folfiri","folfox"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07702032","phase":"3","setting":"A Randomized, Open-label, Phase 3 Trial of Petosemtamab in Combination With mFOLFOX6 or FOLFIRI Versus Cetuximab in Combination With mFOLFOX6 or FOLFIRI as First-line Treatment for Participants With RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer","sponsor":"Genmab","started":"2026-08-11","startedType":"actual","enrolled":960,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06760637","kind":"trial","name":"Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease","aka":["FOURLIGHT-3"],"tldr":"A phase 3 trial of Atirmociclib, Abemaciclib, Palbociclib and Ribociclib in HR-positive / HER2-negative breast cancer, run by Pfizer, active and no longer recruiting.","summary":"Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease is a phase 3 interventional study registered as NCT06760637 by Pfizer, with 1035 participants enrolled, started 2025-01-06 and due to reach its primary completion in 2029-01-02. Interventions recorded: PF-07220060, letrozole, abemaciclib, palbociclib and ribociclib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06760637","url":"https://clinicaltrials.gov/study/NCT06760637"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["atirmociclib","abemaciclib","palbociclib","ribociclib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06760637","phase":"3","setting":"AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO CDK4/6 INHIBITOR PLUS LETROZOLE IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTICANCER TREATMENT FOR ADVANCED/METASTATIC DISEASE (FOURLIGHT-3)","sponsor":"Pfizer","started":"2025-01-06","startedType":"actual","enrolled":1035,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04606446","kind":"trial","name":"Study of PF-07248144 in Advanced or Metastatic Solid Tumors","aka":[],"tldr":"A phase 2 trial of PF-07248144, Fulvestrant, Letrozole in prostate cancer and non-small-cell lung cancer, run by Pfizer, now recruiting.","summary":"Study of PF-07248144 in Advanced or Metastatic Solid Tumors is a phase 2 interventional study registered as NCT04606446 by Pfizer, with 320 participants planned, started 2020-11-16 and due to reach its primary completion in 2029-07-13. Interventions recorded: PF-07248144, Fulvestrant, Letrozole, Palbociclib, PF-07220060. Conditions listed: Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer, Locally Advanced or Metastatic Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04606446","url":"https://clinicaltrials.gov/study/NCT04606446"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-07248144","fulvestrant","letrozole","palbociclib","atirmociclib","vepdegestrant"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04606446-nat-med-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04606446","phase":"2","setting":"A PHASE 1/2A DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07248144 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS","sponsor":"Pfizer","started":"2020-11-16","startedType":"actual","enrolled":320,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05804045","kind":"trial","name":"Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)","aka":["MANEUVER"],"tldr":"A phase 3 trial of Pimicotinib(ABSK021) in tenosynovial giant cell tumour, run by Abbisko Therapeutics Co, Ltd, active and no longer recruiting.","summary":"Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER) is a phase 3 interventional study registered as NCT05804045 by Abbisko Therapeutics Co, Ltd, with 94 participants enrolled, started 2023-04-27 and due to reach its primary completion in 2024-09-23. Interventions recorded: Pimicotinib(ABSK021) and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05804045","url":"https://clinicaltrials.gov/study/NCT05804045"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tenosynovial-giant-cell-tumour"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["abbisko"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05804045","phase":"3","setting":"A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of ABSK021 to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor","sponsor":"Abbisko Therapeutics Co, Ltd","started":"2023-04-27","startedType":"actual","yearReported":2026,"enrolled":94,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Part 1- Pimicotinib(ABSK021)","n":63,"value":54,"note":"95% CI 40.9 to 66.6; Figures from the ClinicalTrials.gov results section (first posted 2026-05-04), not from a publication"},{"name":"Part 1- Placebo","n":31,"value":3.2,"note":"95% CI 0.1 to 16.7"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT05804045?tab=results"}]},{"id":"nct07499362","kind":"trial","name":"Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)","aka":["J-MANEUVER"],"tldr":"A phase 2 trial of Pimicotinib in tenosynovial giant cell tumour, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, now recruiting.","summary":"Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER) is a phase 2 interventional study registered as NCT07499362 by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, with 20 participants planned, started 2026-03-26 and due to reach its primary completion in 2029-11-22. Interventions recorded: Pimicotinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07499362","url":"https://clinicaltrials.gov/study/NCT07499362"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tenosynovial-giant-cell-tumour"],"sections":[],"technologies":[],"targets":[],"drugs":["pimicotinib"],"companies":["merck-kgaa"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07499362","phase":"2","setting":"Phase 2, Single-arm Study to Investigate the Tolerability, Pharmacokinetics, Efficacy, and Safety of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","started":"2026-03-26","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03458260","kind":"trial","name":"Study of Pixantrone in CD20+ Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma","aka":[],"tldr":"A phase 2 trial of Pixantrone, Ifosfamide, Etoposide and Rituximab in Non-Hodgkin lymphoma, run by The Lymphoma Academic Research Organisation, completed.","summary":"Study of Pixantrone in CD20+ Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma is a phase 2 interventional study registered as NCT03458260 by The Lymphoma Academic Research Organisation, with 74 participants recorded, started 2018-12-26 and reaching its primary completion in 2024-12-24. Interventions recorded: Pixantrone, Ifosfamide, Etoposide, Rituximab, Transplant. Conditions recorded: Aggressive Non-Hodgkin Lymphoma.\n\nLinked to the drug Pixantrone because the registry names it among its interventions and Non-Hodgkin lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03458260","url":"https://clinicaltrials.gov/study/NCT03458260"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["pixantrone","ifosfamide","etoposide","rituximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03458260","phase":"2","setting":"A Multicentre, Phase II, Open Label, Single Arm Study of Pixantrone in Patients With CD20-positive Relapsed or Refractory Aggressive Non-Hodgkin Lymphoma Treated With Rituximab, Ifosfamide and Etoposide.","sponsor":"The Lymphoma Academic Research Organisation","started":"2018-12-26","startedType":"actual","enrolled":74,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05450965","kind":"trial","name":"Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of onvansertib in lung cancer, run by University of Maryland, Baltimore, now recruiting.","summary":"Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer is a phase 2, interventional study registered as NCT05450965 by University of Maryland, Baltimore, with a registry enrolment figure of 37 participants, started 2022-07-19 and due to reach its primary completion in 2027-08-31. Interventions recorded: Onvansertib. Conditions listed: Small-cell Lung Cancer; Small Cell Lung Carcinoma. Primary outcome: Objective Response Rate (ORR). Lung eligibility wording from the registry: \"Patients must have histologically or cytologically confirmed small cell lung cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05450965","url":"https://clinicaltrials.gov/study/NCT05450965"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["onvansertib"],"companies":["cardiff-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05450965","phase":"2","setting":"A Phase 2 Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer","sponsor":"University of Maryland, Baltimore","started":"2022-07-19","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07644039","kind":"trial","name":"Study of PM54 in Combination With Immunotherapy in Adult Participants With Advanced Malignancies","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by PharmaMar, now recruiting.","summary":"Study of PM54 in Combination With Immunotherapy in Adult Participants With Advanced Malignancies is a phase 1/2 interventional study registered as NCT07644039 by PharmaMar, with 119 participants planned, started 2026-05-21 and due to reach its primary completion in 2029-04-02. Interventions recorded: Pembrolizumab and PM54.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07644039","url":"https://clinicaltrials.gov/study/NCT07644039"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["pharmamar"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07644039","phase":"1/2","setting":"A Multicenter, Open-label, Phase 1/2 Safety Run-in and Expansion Study of PM54 in Combination With Immunotherapy Evaluating Safety and Efficacy in Adult Participants Who Were Previously Treated for Advanced Malignancies","sponsor":"PharmaMar","started":"2026-05-21","startedType":"actual","enrolled":119,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02659514","kind":"trial","name":"Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer","aka":[],"tldr":"A phase 2 trial of Poziotinib in Breast cancer, run by Spectrum Pharmaceuticals, Inc, completed.","summary":"Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer is a phase 2 interventional study registered as NCT02659514 by Spectrum Pharmaceuticals, Inc, with 67 participants recorded, started 2016-02-22 and reaching its primary completion in 2020-03-11. Interventions recorded: Poziotinib. Conditions recorded: Breast Cancer.\n\nLinked to the drug Poziotinib because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02659514","url":"https://clinicaltrials.gov/study/NCT02659514"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["poziotinib"],"companies":["spectrum-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02659514","phase":"2","setting":"A Phase 2 Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer (MBC) Who Have Received Prior HER2 Regimens for MBC","sponsor":"Spectrum Pharmaceuticals, Inc","started":"2016-02-22","startedType":"actual","yearReported":2022,"enrolled":67,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Cohort 1: Poziotinib 24 mg","n":30,"value":30,"note":"95% CI 14.7 to 49.4; Figures from the ClinicalTrials.gov results section (first posted 2022-02-10), not from a publication"},{"name":"Cohort 2: Poziotinib 16 mg","n":27,"value":30,"note":"95% CI 13.8 to 50.2"}],"source":"https://clinicaltrials.gov/study/NCT02659514?tab=results"},{"endpoint":"Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Cohort 1: Poziotinib 24 mg","n":30,"value":4.1,"note":"95% CI 1.5 to 5.6; Figures from the ClinicalTrials.gov results section (first posted 2022-02-10), not from a publication"},{"name":"Cohort 2: Poziotinib 16 mg","n":27,"value":4.9,"note":"95% CI 1.8 to 7.4"}],"source":"https://clinicaltrials.gov/study/NCT02659514?tab=results"}]},{"id":"nct05563844","kind":"trial","name":"Study of Purinostat Mesylate for Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)","aka":[],"tldr":"A phase 2 trial of PM 8.4 mg/m^2 in diffuse large B-cell lymphoma, run by Chengdu Zenitar Biomedical Technology Co., Ltd, active and no longer recruiting.","summary":"Study of Purinostat Mesylate for Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) is a phase 2 interventional study registered as NCT05563844 by Chengdu Zenitar Biomedical Technology Co., Ltd, with 74 participants enrolled, started 2022-11-08 and due to reach its primary completion in 2026-12-30. Interventions recorded: PM 8.4 mg/m^2 and PM 11.2 mg/m^2.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05563844","url":"https://clinicaltrials.gov/study/NCT05563844"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["chengdu-zenitar-biomedical-technology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05563844","phase":"2","setting":"An Open-label, Multi-center Phase II Clinical Study on the Efficacy and Safety of Purinostat Mesylate for Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)","sponsor":"Chengdu Zenitar Biomedical Technology Co., Ltd","started":"2022-11-08","startedType":"actual","enrolled":74,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06608927","kind":"trial","name":"Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma","aka":["PRISM-1"],"tldr":"A phase 3 trial testing Quemliclustat in pancreatic ductal adenocarcinoma, active and no longer recruiting.","summary":"Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma is a phase 3 interventional study registered as NCT06608927, led by Arcus Biosciences with Taiho Pharmaceutical, and active but no longer recruiting on the registry. Official title: A Randomised, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma. Planned enrolment is 610 participants (estimated). The study started in 2024-12-13 and primary completion is expected in 2030-11-30. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06608927","url":"https://clinicaltrials.gov/study/NCT06608927"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["quemliclustat"],"companies":["arcus-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06608927","phase":"3","setting":"A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma","sponsor":"Arcus Biosciences","started":"2024-12-13","startedType":"actual","enrolled":610,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05308264","kind":"trial","name":"Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)","aka":[],"tldr":"A phase 1/2 trial of R906289 Monosodium (R289 Na) in myelodysplastic syndromes / neoplasms, run by Rigel Pharmaceuticals, now recruiting.","summary":"Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS) is a phase 1/2 interventional study registered as NCT05308264 by Rigel Pharmaceuticals, with 86 participants planned, started 2022-09-12 and due to reach its primary completion in 2026-08. Interventions recorded: R906289 Monosodium (R289 Na).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05308264","url":"https://clinicaltrials.gov/study/NCT05308264"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mds","mds-lower-risk"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["rigel-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05308264","phase":"1/2","setting":"An Open-label, Phase 1b Study of R289, an IRAK1/4 Inhibitor, in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS) Who Are Relapsed/Refractory/Resistant to Prior Therapies","sponsor":"Rigel Pharmaceuticals","started":"2022-09-12","startedType":"actual","enrolled":86,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07638852","kind":"trial","name":"Study of Radiotherapy Combined With Cisplatin/Carboplatin, Adebrelimab and Bevacizumab in the Treatment of TNBC-BM.","aka":["ABC-R"],"tldr":"A phase 2 trial of bevacizumab, cisplatin and carboplatin in triple-negative breast cancer, run by Fudan University, now recruiting.","summary":"Study of Radiotherapy Combined With Cisplatin/Carboplatin, Adebrelimab and Bevacizumab in the Treatment of TNBC-BM. is a phase 2, randomised interventional study registered as NCT07638852 by Fudan University, with a registry enrolment figure of 58 participants, started 2026-02-02 and due to reach its primary completion in 2028-06-30. Interventions recorded: Radiation Therapy; Adebelimab; Bevacizumab; Cisplatin or carboplatin. Conditions listed: TNBC, Triple Negative Breast Cancer; Brain Metastasases. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07638852","url":"https://clinicaltrials.gov/study/NCT07638852"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","brain-metastases"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["bevacizumab","cisplatin","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07638852","phase":"2","setting":"A Prospective, Two-arm, Multi-centre, Phase II Clinical Study of Radiotherapy Combined With Cisplatin/Carboplatin, Adebrelimab and Bevacizumab in the Treatment of Patients With Brain Metastasis From Triple-Negative Breast Cancer","sponsor":"Fudan University","started":"2026-02-02","startedType":"actual","enrolled":58,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07397338","kind":"trial","name":"Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Daraxonrasib, Elironrasib, Zoldonrasib in non-small-cell lung cancer and small-cell lung cancer, run by Revolution Medicines, Inc., now recruiting.","summary":"Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors is a phase 1/2 interventional study registered as NCT07397338 by Revolution Medicines, Inc., with 370 participants planned, started 2026-01-30 and due to reach its primary completion in 2029-05. Interventions recorded: Daraxonrasib, Elironrasib, Zoldonrasib, Ivonescimab, Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only). Conditions listed: Advanced Solid Tumors, Metastatic Solid Tumors, Non-small Cell Lung Cancer (NSCLC), NSCLC. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07397338","url":"https://clinicaltrials.gov/study/NCT07397338"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","colorectal"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["daraxonrasib","elironrasib","zoldonrasib","ivonescimab","carboplatin","cisplatin"],"companies":["revolution-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07397338","phase":"1/2","setting":"A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With Solid Tumors","sponsor":"Revolution Medicines, Inc.","started":"2026-01-30","startedType":"actual","enrolled":370,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06162221","kind":"trial","name":"Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC","aka":[],"tldr":"A phase 1/2 trial of Elironrasib, Daraxonrasib, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Revolution Medicines, Inc., now recruiting.","summary":"Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC is a phase 1/2 interventional study registered as NCT06162221 by Revolution Medicines, Inc., with 616 participants planned, started 2024-01-18 and due to reach its primary completion in 2027-06. Interventions recorded: RMC-6291, RMC-6236, Pembrolizumab, Cisplatin, Carboplatin. Conditions listed: Non-Small Cell Lung Cancer, NSCLC, KRAS, NRAS, HRAS-mutated NSCLC, KRAS G12C-mutated Solid Tumors, Lung Cancer, Lung Cancer Stage IV, Advanced Solid Tumor, Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06162221","url":"https://clinicaltrials.gov/study/NCT06162221"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["elironrasib","daraxonrasib","pembrolizumab","cisplatin","carboplatin","pemetrexed"],"companies":["revolution-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06162221","phase":"1/2","setting":"A Platform Study of RAS(ON) Inhibitors in Patients With RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Revolution Medicines, Inc.","started":"2024-01-18","startedType":"actual","enrolled":616,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06445062","kind":"trial","name":"Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Daraxonrasib, Bevacizumab, Cetuximab in colorectal cancer and pancreatic ductal adenocarcinoma, run by Revolution Medicines, Inc., now recruiting.","summary":"Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors is a phase 1/2 interventional study registered as NCT06445062 by Revolution Medicines, Inc., with 1130 participants planned, started 2024-05-24 and due to reach its primary completion in 2027-05-15. Interventions recorded: RMC-6236, mFOLFOX6 regimen, bevacizumab, mFOLFIRINOX regimen, cetuximab. Conditions listed: Colorectal Cancer, CRC, Pancreatic Ductal Adenocarcinoma, PDAC. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06445062","url":"https://clinicaltrials.gov/study/NCT06445062"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["daraxonrasib","bevacizumab","cetuximab","gemcitabine","paclitaxel","zoldonrasib"],"companies":["revolution-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06445062","phase":"1/2","setting":"A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors","sponsor":"Revolution Medicines, Inc.","started":"2024-05-24","startedType":"actual","enrolled":1130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03564340","kind":"trial","name":"Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent","aka":[],"tldr":"A phase 1/2 trial of Cemiplimab, Tocilizumab in ovarian cancer and endometrial cancer, run by Regeneron Pharmaceuticals, now recruiting.","summary":"Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers is a phase 1/2 interventional study registered as NCT03564340 by Regeneron Pharmaceuticals, with 890 participants planned, started 2018-05-21 and due to reach its primary completion in 2027-05-10. Interventions recorded: Ubamatamab, Cemiplimab, Sarilumab, Tocilizumab. Conditions listed: Recurrent Ovarian Cancer, Recurrent Fallopian Tube Cancer, Recurrent Primary Peritoneal Cancer, Recurrent Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03564340","url":"https://clinicaltrials.gov/study/NCT03564340"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","endometrial"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab","tocilizumab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03564340","phase":"1/2","setting":"A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers","sponsor":"Regeneron Pharmaceuticals","started":"2018-05-21","startedType":"actual","enrolled":890,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07125872","kind":"trial","name":"Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma","aka":[],"tldr":"A phase 2 trial of CD19 t-haNK in non-Hodgkin lymphoma, run by ImmunityBio, Inc., now recruiting.","summary":"Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma is a phase 2 interventional study registered as NCT07125872 by ImmunityBio, Inc., with 20 participants planned, started 2025-11-11 and due to reach its primary completion in 2027-05-25. Interventions recorded: CD19 t-haNK- IV Administration.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07125872","url":"https://clinicaltrials.gov/study/NCT07125872"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["cd19-t-hank"],"companies":["immunitybio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07125872","phase":"2","setting":"Open Label, Phase 2 Study of CD19 t-haNK and N-803 in Combination With Rituximab in Participants With Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma","sponsor":"ImmunityBio, Inc.","started":"2025-11-11","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06118086","kind":"trial","name":"Study of REM-422 in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma","aka":[],"tldr":"A phase 1/2 trial of REM-422 in salivary gland cancers, run by Remix Therapeutics, now recruiting.","summary":"Study of REM-422 in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma is a phase 1/2 interventional study registered as NCT06118086 by Remix Therapeutics, with 125 participants planned, started 2023-12-20 and due to reach its primary completion in 2027-09-30. Interventions recorded: REM-422.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06118086","url":"https://clinicaltrials.gov/study/NCT06118086"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["salivary-gland","adenoid-cystic-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["rem-422"],"companies":["remix-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06118086","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open-label Study of REM-422, a MYB mRNA Degrader, in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma","sponsor":"Remix Therapeutics","started":"2023-12-20","startedType":"actual","enrolled":125,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04683250","kind":"trial","name":"Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities","aka":["MARGARET"],"tldr":"A phase 1/2 trial of TAS0953/HM06 in non-small-cell lung cancer, run by Taiho Pharmaceutical Co., Ltd., now recruiting.","summary":"Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities is a phase 1/2 interventional study registered as NCT04683250 by Taiho Pharmaceutical Co., Ltd., with 244 participants planned, started 2020-12-16 and due to reach its primary completion in 2030-03. Interventions recorded: TAS0953/HM06.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04683250","url":"https://clinicaltrials.gov/study/NCT04683250"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","ret-fusion-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["araris"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04683250","phase":"1/2","setting":"Phase I/II Study of the Selective RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities","sponsor":"Taiho Pharmaceutical Co., Ltd.","started":"2020-12-16","startedType":"actual","enrolled":244,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05287113","kind":"trial","name":"Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck","aka":[],"tldr":"A phase 2 trial of Retifanlimab in head and neck squamous cell carcinoma, run by Incyte Biosciences International Sàrl, active and no longer recruiting.","summary":"Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck is a phase 2 interventional study registered as NCT05287113 by Incyte Biosciences International Sàrl, with 176 participants enrolled, started 2022-11-14 and due to reach its primary completion in 2025-03-14. Interventions recorded: Retifanlimab, INCAGN02385, INCAGN02390 and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05287113","url":"https://clinicaltrials.gov/study/NCT05287113"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["retifanlimab"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05287113","phase":"2","setting":"A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti-LAG-3) and INCAGN02390 (Anti-TIM-3) as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck","sponsor":"Incyte Biosciences International Sàrl","started":"2022-11-14","startedType":"actual","yearReported":2026,"enrolled":176,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progeression-free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Retifanlimab","n":59,"value":5.6,"note":"95% CI 3.5 to 9.7; Figures from the ClinicalTrials.gov results section (first posted 2026-03-27), not from a publication"},{"name":"Retifanlimab Plus INCAGN02385","n":60,"value":5.8,"note":"95% CI 3.7 to 7.6"},{"name":"Retifanlimab Plus INCAGN02385 Plus INCAGN02390","n":57,"value":5.3,"note":"95% CI 2.1 to 7.9"}],"source":"https://clinicaltrials.gov/study/NCT05287113?tab=results"}]},{"id":"nct07211958","kind":"trial","name":"Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation","aka":["REVEAL-ND NPM1"],"tldr":"A phase 3 trial of Revumenib in acute myeloid leukaemia, run by Syndax Pharmaceuticals, now recruiting.","summary":"Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation is a phase 3 interventional study registered as NCT07211958 by Syndax Pharmaceuticals, with 468 participants planned, started 2025-11-25 and due to reach its primary completion in 2029-06. Interventions recorded: Revumenib, Placebo and Intensive Chemotherapy Regimen.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07211958","url":"https://clinicaltrials.gov/study/NCT07211958"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["epigenetic-drugs"],"targets":[],"drugs":["revumenib"],"companies":["syndax"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07211958","phase":"3","setting":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation","sponsor":"Syndax Pharmaceuticals","started":"2025-11-25","startedType":"actual","enrolled":468,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05838729","kind":"trial","name":"Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer","aka":[],"tldr":"A phase 1/2 trial of RiMO-301 in advanced solid tumours, run by Coordination Pharmaceuticals, Inc., now recruiting.","summary":"Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer is a phase 1/2 interventional study registered as NCT05838729 by Coordination Pharmaceuticals, Inc., with 16 participants planned, started 2023-04-03 and due to reach its primary completion in 2026-09. Interventions recorded: RiMO-301.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05838729","url":"https://clinicaltrials.gov/study/NCT05838729"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["hypofractionated-radiotherapy"],"targets":["pd1"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05838729","phase":"1/2","setting":"Phase 1b/2a Study of RiMO-301 and Hypofractionated Radiotherapy With A PD-1 Inhibitor for the Treatment of Unresectable, Recurrent or Metastatic Head-Neck Cancer","sponsor":"Coordination Pharmaceuticals, Inc.","started":"2023-04-03","startedType":"actual","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05379985","kind":"trial","name":"Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS","aka":["RMC-6236-001","Daraxonrasib phase 1/2"],"tldr":"A phase 1/2 trial of Daraxonrasib in non-small-cell lung cancer and small-cell lung cancer, run by Revolution Medicines, Inc., now recruiting.","summary":"Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS is a phase 1/2 interventional study registered as NCT05379985 by Revolution Medicines, Inc., with 754 participants planned, started 2022-05-31 and due to reach its primary completion in 2027-05-31. Interventions recorded: RMC-6236. Conditions listed: Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05379985","url":"https://clinicaltrials.gov/study/NCT05379985"},{"label":"Wolpin et al., daraxonrasib in previously treated advanced RAS-mutated pancreatic cancer (NEJM 2026)","url":"https://doi.org/10.1056/NEJMoa2505783"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","colorectal","pancreatic","metastatic-pdac"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["daraxonrasib"],"companies":["revolution-medicines"],"institutions":[],"pathways":[],"terms":["kras-mutation-subtypes"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05379985-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":["Pancreatic cohort of the phase 1/2 (NEJM 2026, Wolpin et al.): 168 previously treated patients with RAS-mutated pancreatic ductal adenocarcinoma received daraxonrasib at 300 mg or less; treatment-related adverse events of any grade in 96 percent and grade 3 or higher in 30 percent (rash, diarrhoea, nausea, stomatitis, vomiting, fatigue the commonest). In 26 patients with RAS G12 mutations treated second line at 300 mg the response rate was 35 percent with median progression-free survival 8.5 and overall survival 13.1 months; in 38 with G12, G13 or Q61 mutations 29 percent, 8.1 and 15.6 months. These figures set the 300 mg phase 3 dose for RASolute 302."],"nct":"NCT05379985","phase":"1/2","setting":"A Multicenter Open-Label Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS","sponsor":"Revolution Medicines, Inc.","result":"Second-line daraxonrasib 300 mg in 26 patients with RAS G12-mutated pancreatic cancer: objective response 35 percent, median progression-free survival 8.5 months, median overall survival 13.1 months; grade 3 or higher treatment-related adverse events in 30 percent of 168 pancreatic patients.","started":"2022-05-31","startedType":"actual","yearReported":2026,"enrolled":754,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response, second-line RAS G12 pancreatic cancer at 300 mg","unit":"%","arms":[{"name":"Daraxonrasib 300 mg","n":26,"value":35,"note":"95% CI 17 to 56; median duration of response 8.2 months"}],"source":"https://doi.org/10.1056/NEJMoa2505783"},{"endpoint":"Overall survival, second-line RAS G12 pancreatic cancer at 300 mg","unit":"months","arms":[{"name":"Daraxonrasib 300 mg","n":26,"value":13.1}],"source":"https://doi.org/10.1056/NEJMoa2505783"}]},{"id":"nct06040541","kind":"trial","name":"Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors","aka":["RMC-9805-001"],"tldr":"A phase 1 trial of zoldonrasib (RMC-9805) alone or with daraxonrasib (RMC-6236) in KRAS G12D-mutant solid tumours, including pancreatic, bowel and non-small-cell lung cancer, run by Revolution Medicines, now recruiting.","summary":"Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors is a phase 1/1b interventional study registered as NCT06040541 by Revolution Medicines, Inc., with an estimated 604 participants across the whole study. Two arms are recorded: RMC-9805 (zoldonrasib) monotherapy and RMC-9805 plus RMC-6236 (daraxonrasib). Conditions listed: non-small cell lung cancer, colorectal cancer, pancreatic ductal adenocarcinoma and advanced solid tumours. The registry carries no results; the combination cohort figures reported by the sponsor at ESMO GI 2026 sit on the pairing record g12d-plus-pan-ras.","status":"recruiting","asOf":"2026-09-21","links":[{"label":"ClinicalTrials.gov NCT06040541","url":"https://clinicaltrials.gov/study/NCT06040541"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","colorectal","nsclc"],"sections":[],"technologies":["kras-inhibitors"],"targets":["kras"],"drugs":["zoldonrasib","daraxonrasib"],"companies":["revolution-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06040541","phase":"1","setting":"Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors","sponsor":"Revolution Medicines, Inc.","started":"2023-09-07","startedType":"actual","enrolled":604,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03937154","kind":"trial","name":"Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer","aka":["PROCLAIM"],"tldr":"A phase 3 trial of Romiplostim in non-small-cell lung cancer, run by Amgen, active and no longer recruiting.","summary":"Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer is a phase 3 interventional study registered as NCT03937154 by Amgen, with 145 participants enrolled, started 2020-02-26 and due to reach its primary completion in 2026-03-10. Interventions recorded: Romiplostim and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03937154","url":"https://clinicaltrials.gov/study/NCT03937154"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["supportive-care"],"targets":[],"drugs":["romiplostim"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03937154","phase":"3","setting":"PROCLAIM: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer","sponsor":"Amgen","started":"2020-02-26","startedType":"actual","enrolled":145,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05826535","kind":"trial","name":"Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma","aka":[],"tldr":"A phase 1/2 trial of Rondecabtagene autoleucel, Fludarabine, Cyclophosphamide in hodgkin lymphoma and non-hodgkin lymphoma, run by Lyell Immunopharma, Inc., now recruiting.","summary":"Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma is a phase 1/2 interventional study registered as NCT05826535 by Lyell Immunopharma, Inc., with 270 participants planned, started 2023-05-09 and due to reach its primary completion in 2028-12-31. Interventions recorded: Rondecabtagene autoleucel (ronde-cel), Fludarabine, Cyclophosphamide. Conditions listed: Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Large B-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05826535","url":"https://clinicaltrials.gov/study/NCT05826535"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["rondecabtagene-autoleucel","fludarabine","cyclophosphamide"],"companies":["lyell-immunopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05826535","phase":"1/2","setting":"A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of Rondecabtagene Autoleucel, a CD19/CD20 Dual-Targeting Chimeric Antigen Receptor T-Cell Therapy in Participants With Aggressive B-Cell Non-Hodgkin Lymphoma","sponsor":"Lyell Immunopharma, Inc.","started":"2023-05-09","startedType":"actual","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02674568","kind":"trial","name":"Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer","aka":["SC16LD6.5"],"tldr":"A phase 2 trial of Rovalpituzumab tesirine in Small-cell lung cancer, run by AbbVie, completed.","summary":"Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer is a phase 2 interventional study registered as NCT02674568 by AbbVie, with 342 participants recorded, started 2016-01-25 and reaching its primary completion in 2018-10-19. Interventions recorded: Rovalpituzumab tesirine. Conditions recorded: Small Cell Lung Cancer.\n\nLinked to the drug Rovalpituzumab tesirine because the registry names it among its interventions and Small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02674568","url":"https://clinicaltrials.gov/study/NCT02674568"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["rovalpituzumab-tesirine"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02674568","phase":"2","setting":"An Open-label, Single-Arm, Phase 2 Study Evaluating the Efficacy, Safety and Pharmacokinetics of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY)","sponsor":"AbbVie","started":"2016-01-25","startedType":"actual","yearReported":2019,"enrolled":342,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival","primary":true,"unit":"months","arms":[{"name":"Rovalpituzumab Tesirine: DLL3 High","n":238,"value":5.3,"note":"95% CI 4.7 to 5.8; Figures from the ClinicalTrials.gov results section (first posted 2019-10-23), not from a publication"},{"name":"Rovalpituzumab Tesirine: DLL3 Positive","n":287,"value":5.3,"note":"95% CI 4.7 to 5.8"}],"source":"https://clinicaltrials.gov/study/NCT02674568?tab=results"}]},{"id":"nct03767348","kind":"trial","name":"Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)","aka":["IGNYTE"],"tldr":"A phase 2 trial of Nivolumab in non-small-cell lung cancer and small-cell lung cancer, run by Replimune, Inc., active and no longer recruiting.","summary":"Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) is a phase 2 interventional study registered as NCT03767348 by Replimune, Inc., with 340 participants planned, started 2017-09-20 and due to reach its primary completion in 2028-06. Interventions recorded: RP1, nivolumab. Conditions listed: Non-Small Cell Lung Cancer (NSCLC), Microsatellite Instability-High (MSI-H), Non-melanoma Skin Cancer (NMSC), Cutaneous Melanoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03767348","url":"https://clinicaltrials.gov/study/NCT03767348"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","melanoma","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["replimune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03767348","phase":"2","setting":"An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors [IGNYTE]","sponsor":"Replimune, Inc.","started":"2017-09-20","startedType":"actual","enrolled":340,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05733598","kind":"trial","name":"Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC","aka":[],"tldr":"A phase 2 trial of Bevacizumab, Atezolizumab, Durvalumab in hepatocellular carcinoma, run by Replimune, Inc., now recruiting.","summary":"Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC is a phase 2 interventional study registered as NCT05733598 by Replimune, Inc., with 60 participants planned, started 2024-08-01 and due to reach its primary completion in 2027-12-01. Interventions recorded: RP2, Bevacizumab, Atezolizumab, Durvalumab, RP2 Monotherapy. Conditions listed: Hepatocellular Carcinoma, Biliary Tract Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05733598","url":"https://clinicaltrials.gov/study/NCT05733598"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab","atezolizumab","durvalumab"],"companies":["replimune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05733598","phase":"2","setting":"A Phase 2, Open-label, Multicenter Study Investigating RP2 Oncolytic Immunotherapy in Combination With Second-line Therapy in Patients With Locally Advanced Unresectable, Recurrent and/or Metastatic Hepatocellular Carcinoma","sponsor":"Replimune, Inc.","started":"2024-08-01","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04114825","kind":"trial","name":"Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer","aka":["BRaVac"],"tldr":"A phase 2 trial of RV001V in prostate cancer, run by RhoVac APS, active and no longer recruiting.","summary":"Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer is a phase 2 interventional study registered as NCT04114825 by RhoVac APS, with 180 participants enrolled, started 2019-11-19 and due to reach its primary completion in 2022-04. Interventions recorded: RV001V.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04114825","url":"https://clinicaltrials.gov/study/NCT04114825"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["rv001v"],"companies":["rhovac"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04114825","phase":"2","setting":"A Phase 2, Double-Blind, Placebo Controlled Study of RV001V in Men With Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer (BRaVac)","sponsor":"RhoVac APS","started":"2019-11-19","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05101096","kind":"trial","name":"Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors","aka":["ASCENT-J02"],"tldr":"A phase 1/2 trial of Sacituzumab govitecan in triple-negative breast cancer and bladder & urothelial cancer, run by Gilead Sciences, active and no longer recruiting.","summary":"Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05101096 by Gilead Sciences, with 135 participants enrolled, started 2021-10-20 and due to reach its primary completion in 2027-05. Interventions recorded: Sacituzumab Govitecan-hziy.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05101096","url":"https://clinicaltrials.gov/study/NCT05101096"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","urothelial"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05101096-int-j-clin-oncol-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05101096","phase":"1/2","setting":"A Phase 1/2 Open-Label Study of Sacituzumab Govitecan in Japanese Patients With Advanced Solid Tumors (ASCENT-J02)","sponsor":"Gilead Sciences","started":"2021-10-20","startedType":"actual","enrolled":135,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05089734","kind":"trial","name":"Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","aka":["EVOKE-01"],"tldr":"A phase 3 trial of Sacituzumab govitecan, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by Gilead Sciences, active and no longer recruiting.","summary":"Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) is a phase 3 interventional study registered as NCT05089734 by Gilead Sciences, with 603 participants enrolled, started 2021-11-17 and due to reach its primary completion in 2023-11-29. Interventions recorded: Sacituzumab Govitecan-hziy (SG), Docetaxel. Conditions listed: Non-Small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05089734","url":"https://clinicaltrials.gov/study/NCT05089734"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan","docetaxel"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05089734","phase":"3","setting":"Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy","sponsor":"Gilead Sciences","started":"2021-11-17","startedType":"actual","yearReported":2025,"enrolled":603,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Sacituzumab Govitecan (SG)","n":299,"value":11.1,"note":"95% CI 9.4 to 12.3; Figures from the ClinicalTrials.gov results section (first posted 2025-01-14), not from a publication"},{"name":"Docetaxel","n":304,"value":9.8,"note":"95% CI 8.1 to 10.6"}],"hr":0.84,"ci":[0.68,1.04],"p":"0.0534","source":"https://clinicaltrials.gov/study/NCT05089734?tab=results"}]},{"id":"nct05186974","kind":"trial","name":"Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)","aka":["EVOKE-02"],"tldr":"A phase 2 trial of Sacituzumab govitecan, Pembrolizumab, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Gilead Sciences, active and no longer recruiting.","summary":"Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) is a phase 2 interventional study registered as NCT05186974 by Gilead Sciences, with 193 participants enrolled, started 2022-05-30 and due to reach its primary completion in 2027-03. Interventions recorded: Sacituzumab Govitecan-hziy (SG), Pembrolizumab, Carboplatin, Cisplatin. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05186974","url":"https://clinicaltrials.gov/study/NCT05186974"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan","pembrolizumab","carboplatin","cisplatin"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05186974-j-thorac-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05186974","phase":"2","setting":"An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations","sponsor":"Gilead Sciences","started":"2022-05-30","startedType":"actual","enrolled":193,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04454437","kind":"trial","name":"Study of Sacituzumab Govitecan in Chinese Patients With Metastatic Triple-negative Breast Cancer Who Received at Least Two Prior Treatments","aka":[],"tldr":"A phase 2 trial of Sacituzumab govitecan in triple-negative breast cancer, run by Gilead Sciences, active and no longer recruiting.","summary":"Study of Sacituzumab Govitecan in Chinese Patients With Metastatic Triple-negative Breast Cancer Who Received at Least Two Prior Treatments is a phase 2 interventional study registered as NCT04454437 by Gilead Sciences, with 80 participants enrolled, started 2020-10-23 and due to reach its primary completion in 2021-08-06. Interventions recorded: Sacituzumab Govitecan-hziy.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04454437","url":"https://clinicaltrials.gov/study/NCT04454437"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04454437-int-j-cancer-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04454437","phase":"2","setting":"A Phase IIb, Single Arm, Multicenter Trial of Sacituzumab Govitecan in Chinese Patients With Metastatic Triple-negative Breast Cancer Who Received at Least Two Prior Treatments","sponsor":"Gilead Sciences","started":"2020-10-23","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03964727","kind":"trial","name":"Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors","aka":["TROPiCS-03"],"tldr":"A phase 2 trial of Sacituzumab govitecan in advanced solid tumours, run by Gilead Sciences, active and no longer recruiting.","summary":"Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors is a phase 2 interventional study registered as NCT03964727 by Gilead Sciences, with 227 participants enrolled, started 2019-10-15 and due to reach its primary completion in 2025-01-15. Interventions recorded: Sacituzumab Govitecan-hziy. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03964727","url":"https://clinicaltrials.gov/study/NCT03964727"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03964727","phase":"2","setting":"A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors","sponsor":"Gilead Sciences","started":"2019-10-15","startedType":"actual","yearReported":2026,"enrolled":227,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment","primary":true,"unit":"%","arms":[{"name":"Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]","n":31,"value":12.9,"note":"95% CI 3.6 to 29.8; Figures from the ClinicalTrials.gov results section (first posted 2026-01-30), not from a publication"},{"name":"Cohort 1 Group 2: NSCLC (Adenocarcinoma)","n":34,"value":5.9,"note":"95% CI 0.7 to 19.7"},{"name":"Cohort 1 Group 3: NSCLC (SCC)","n":31,"value":6.5,"note":"95% CI 0.8 to 21.4"},{"name":"Cohort 2: HNSCC","n":43,"value":16.3,"note":"95% CI 6.8 to 30.7"},{"name":"Cohort 3: EC","n":41,"value":26.8,"note":"95% CI 14.2 to 42.9"},{"name":"Cohort 4: ES-SCLC","n":43,"value":44.2,"note":"95% CI 29.1 to 60.1"}],"source":"https://clinicaltrials.gov/study/NCT03964727?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]","n":31,"value":14.26,"note":"95% CI 4.34 to 23.72; Figures from the ClinicalTrials.gov results section (first posted 2026-01-30), not from a publication"},{"name":"Cohort 1 Group 2: NSCLC (Adenocarcinoma)","n":34,"value":11.02,"note":"95% CI 4.24 to 20.47"},{"name":"Cohort 1 Group 3: NSCLC (SCC)","n":31,"value":7.29,"note":"95% CI 5.16 to 10.22"},{"name":"Cohort 2: HNSCC","n":43,"value":8.97,"note":"95% CI 7.52 to 12.22"},{"name":"Cohort 3: EC","n":41,"value":14.95,"note":"95% CI 5.88 to 21.42"},{"name":"Cohort 4: ES-SCLC","n":43,"value":11.73,"note":"95% CI 6.57 to 14.72"}],"source":"https://clinicaltrials.gov/study/NCT03964727?tab=results"}]},{"id":"nct03547973","kind":"trial","name":"Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread","aka":["TROPHY U-01"],"tldr":"A phase 2 trial of Sacituzumab govitecan, Pembrolizumab, Cisplatin, Avelumab, Zimberelimab and Carboplatin in bladder & urothelial cancer, run by Gilead Sciences, active and no longer recruiting.","summary":"Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread is a phase 2 interventional study registered as NCT03547973 by Gilead Sciences, with 502 participants enrolled, started 2018-08-13 and due to reach its primary completion in 2030-04. Interventions recorded: Sacituzumab Govitecan-hziy, Pembrolizumab, Cisplatin, Avelumab, Zimberelimab and Carboplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03547973","url":"https://clinicaltrials.gov/study/NCT03547973"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan","pembrolizumab","cisplatin","avelumab","zimberelimab","carboplatin"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03547973","phase":"2","setting":"A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer","sponsor":"Gilead Sciences","started":"2018-08-13","startedType":"actual","enrolled":502,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05119907","kind":"trial","name":"Study of Sacituzumab Govitecan in Patients With Solid Tumor","aka":[],"tldr":"A phase 2 trial of Sacituzumab govitecan in advanced solid tumours, run by Gilead Sciences, active and no longer recruiting.","summary":"Study of Sacituzumab Govitecan in Patients With Solid Tumor is a phase 2 interventional study registered as NCT05119907 by Gilead Sciences, with 53 participants enrolled, started 2021-10-12 and due to reach its primary completion in 2026-10. Interventions recorded: Sacituzumab Govitecan-hziy.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05119907","url":"https://clinicaltrials.gov/study/NCT05119907"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05119907","phase":"2","setting":"A Phase II Open Label Study of Sacituzumab Govitecan in Patients With Solid Tumor","sponsor":"Gilead Sciences","started":"2021-10-12","startedType":"actual","enrolled":53,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06801834","kind":"trial","name":"Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer","aka":["EVOKE-SCLC-04"],"tldr":"A phase 3 trial of Sacituzumab govitecan, Topotecan, Amrubicin in small-cell lung cancer, run by Gilead Sciences, now recruiting.","summary":"Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer is a phase 3 interventional study registered as NCT06801834 by Gilead Sciences, with 695 participants planned, started 2025-04-04 and due to reach its primary completion in 2029-10. Interventions recorded: Sacituzumab Govitecan (SG), Topotecan, Amrubicin (Japan only), Lurbinectedin (regions/countries where approved and available). Conditions listed: Extensive Stage Small Cell Lung Cancer (ES-SCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06801834","url":"https://clinicaltrials.gov/study/NCT06801834"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan","topotecan","amrubicin","lurbinectedin"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06801834","phase":"3","setting":"A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)","sponsor":"Gilead Sciences","started":"2025-04-04","startedType":"actual","enrolled":695,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06486441","kind":"trial","name":"Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Im","aka":["ASCENT-GYN-01"],"tldr":"A phase 3 trial of Sacituzumab govitecan, Doxorubicin, Paclitaxel / nab-paclitaxel in endometrial cancer, run by Gilead Sciences, active and no longer recruiting.","summary":"Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26) is a phase 3 interventional study registered as NCT06486441 by Gilead Sciences, with 640 participants planned, started 2024-08-28 and due to reach its primary completion in 2029-06. Interventions recorded: Sacituzumab govitecan-hziy, Doxorubicin, Paclitaxel. Conditions listed: Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06486441","url":"https://clinicaltrials.gov/study/NCT06486441"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan","doxorubicin","paclitaxel"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06486441","phase":"3","setting":"A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy","sponsor":"Gilead Sciences","started":"2024-08-28","startedType":"actual","enrolled":640,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05840211","kind":"trial","name":"Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy","aka":["ASCENT-07"],"tldr":"A phase 3 trial of Sacituzumab govitecan and Capecitabine in HR-positive / HER2-negative breast cancer, run by Gilead Sciences, active and no longer recruiting.","summary":"Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy is a phase 3 interventional study registered as NCT05840211 by Gilead Sciences, with 654 participants enrolled, started 2023-05-08 and due to reach its primary completion in 2028-04. Interventions recorded: Sacituzumab Govitecan-hziy, Paclitaxel, Nab-paclitaxel and Capecitabine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05840211","url":"https://clinicaltrials.gov/study/NCT05840211"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","her2-low-metastatic-breast-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan","capecitabine"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05840211","phase":"3","setting":"A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy","sponsor":"Gilead Sciences","started":"2023-05-08","startedType":"actual","enrolled":654,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07339059","kind":"trial","name":"Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of sacituzumab govitecan, atezolizumab and durvalumab in lung cancer, run by Bindu R Potugari, now recruiting.","summary":"Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer is a phase 2, interventional study registered as NCT07339059 by Bindu R Potugari, with a registry enrolment figure of 35 participants, started 2026-05-14 and due to reach its primary completion in 2029-02-01. Interventions recorded: Sacituzumab govitecan; Atezolizumab; Durvalumab. Conditions listed: Small Cell Lung Cancer ( SCLC ); Extensive Stage Small Cell Lung Cancer (ES-SCLC). Primary outcome: Disease Control. Lung eligibility wording from the registry: \"* Participants must have a histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC) and extensive stage at diagnosis or locally advanced disease and unable to receive curative intent radiation\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07339059","url":"https://clinicaltrials.gov/study/NCT07339059"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["sacituzumab-govitecan","atezolizumab","durvalumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07339059","phase":"2","setting":"Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer","sponsor":"Bindu R Potugari","started":"2026-05-14","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07473167","kind":"trial","name":"Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients","aka":[],"tldr":"A phase 1/2 trial of TC011 in diffuse large b-cell lymphoma and follicular lymphoma, run by TICAROS Co., Ltd., now recruiting.","summary":"Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients is a phase 1/2 interventional study registered as NCT07473167 by TICAROS Co., Ltd., with 98 participants planned, started 2023-08-03 and due to reach its primary completion in 2028-02-11. Interventions recorded: TC011. Conditions listed: Relapsed Large B-cell Lymphoma, Refractory Large B-cell Lymphoma, Diffuse Large B-cell Lymphoma (DLBCL), High-grade B-cell Lymphoma (HGBL). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07473167","url":"https://clinicaltrials.gov/study/NCT07473167"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl","follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["tc011"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07473167","phase":"1/2","setting":"A Multi-center, Single Arm, Open-label Phase 1/2 Clinical Trial to Evaluate Safety, and to Explore Efficacy of TC011(CD19 Targeted CAR-T) in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients","sponsor":"TICAROS Co., Ltd.","started":"2023-08-03","startedType":"actual","enrolled":98,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07201519","kind":"trial","name":"Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Michael J Cavnar, MD, now recruiting.","summary":"Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy is a phase 2, randomised interventional study registered as NCT07201519 by Michael J Cavnar, MD, with a registry enrolment figure of 80 participants, started 2026-01-23 and due to reach its primary completion in 2028-02. Interventions recorded: Hepatic Artery Infusion Pump (HAIP); Standard Treatment; Community Treatment; Systemic Chemotherapy Standard of Care; Standard Of Care targeting driver mutations. Conditions listed: Colorectal Cancer Metastatic; Intrahepatic Cholangiocarcinoma. Primary outcome: Percent of participants with HAI Pump still in use at 3 months. Colorectal eligibility wording from the registry: \"* Colorectal adenocarcinoma metastatic to the liver which is either Unresectable (group A) or Resectable (group B; ie, will be completely resected), AND with no definitive clinical or radiographic evidence of extrahepatic disease other than: metastatic disease to resectable peri-hepatic lymph nodes;\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07201519","url":"https://clinicaltrials.gov/study/NCT07201519"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07201519","phase":"2","setting":"Phase IIa Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy","sponsor":"Michael J Cavnar, MD","started":"2026-01-23","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01045304","kind":"trial","name":"Study of SAR240550 (BSI-201) in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of Iniparib, Gemcitabine and Carboplatin in Breast cancer, run by Sanofi, completed.","summary":"Study of SAR240550 (BSI-201) in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer is a phase 2 interventional study registered as NCT01045304 by Sanofi, with 163 participants recorded, started 2010-02 and reaching its primary completion in 2011-03. Interventions recorded: Iniparib, Gemcitabine, Carboplatin. Conditions recorded: Breast Cancer, Metastatic.\n\nLinked to the drug Iniparib because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01045304","url":"https://clinicaltrials.gov/study/NCT01045304"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["iniparib","gemcitabine","carboplatin"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01045304","phase":"2","setting":"Multicenter, Randomized, Open Label Study Evaluating a Poly(ADP-ribose) Polymerase-1(PARP-1) Inhibitor, SAR240550 (BSI-201), Administered Twice Weekly or Weekly, in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer (mTNBC)","sponsor":"Sanofi","started":"2010-02","enrolled":163,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04562389","kind":"trial","name":"Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis","aka":["SENTRY"],"tldr":"A phase 3 trial of Selinexor and Ruxolitinib in myeloproliferative neoplasms, run by Karyopharm Therapeutics Inc, active and no longer recruiting.","summary":"Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis is a phase 3 interventional study registered as NCT04562389 by Karyopharm Therapeutics Inc, with 353 participants enrolled, started 2021-03-11 and due to reach its primary completion in 2026-02-20. Interventions recorded: Selinexor and Ruxolitinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04562389","url":"https://clinicaltrials.gov/study/NCT04562389"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","primary-myelofibrosis"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["selinexor","ruxolitinib"],"companies":["karyopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04562389","phase":"3","setting":"A Phase 1/3 Study to Evaluate Efficacy and Safety of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination With Ruxolitinib in Treatment-naïve Patients With Myelofibrosis","sponsor":"Karyopharm Therapeutics Inc","started":"2021-03-11","startedType":"actual","enrolled":353,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04782687","kind":"trial","name":"Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma","aka":[],"tldr":"A phase 2 trial of Selinexor, Daratumumab, Lenalidomide in multiple myeloma, run by US Oncology Research, active and no longer recruiting.","summary":"Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma is a phase 2 interventional study registered as NCT04782687 by US Oncology Research, with 73 participants enrolled, started 2021-09-10 and due to reach its primary completion in 2026-05-31. Interventions recorded: Selinexor, Dexamethasone Oral, Daratumumab, Lenalidomide. Conditions listed: Multiple Myeloma, Myeloma Multiple, Kahler Disease, Myeloma, Plasma Cell. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04782687","url":"https://clinicaltrials.gov/study/NCT04782687"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["kinase-inhibitors","monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["selinexor","daratumumab","lenalidomide"],"companies":["mckesson-us-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04782687","phase":"2","setting":"A Phase II Trial of Daratumumab, Lenalidomide and Dexamethasone (DRd) in Combination With Selinexor for Patients With Newly Diagnosed Multiple Myeloma","sponsor":"US Oncology Research","started":"2021-09-10","startedType":"actual","enrolled":73,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06247956","kind":"trial","name":"Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the Treatment of Advanced Gastric and Esophageal Cancer","aka":[],"tldr":"A phase 2 trial of Adebrelimab, Capecitabine, Cisplatin, Oxaliplatin and SHR-8068 in gastric & gastro-oesophageal junction cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., active and no longer recruiting.","summary":"Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the Treatment of Advanced Gastric and Esophageal Cancer is a phase 2 interventional study registered as NCT06247956 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 153 participants enrolled, started 2024-03-11 and due to reach its primary completion in 2025-12-30. Interventions recorded: SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection and Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06247956","url":"https://clinicaltrials.gov/study/NCT06247956"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["adebrelimab","capecitabine","cisplatin","oxaliplatin","shr-8068"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06247956","phase":"2","setting":"A Randomized, Open, Multicenter Phase II Clinical Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the First-line Treatment of Advanced Gastric and Esophageal Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2024-03-11","startedType":"actual","enrolled":153,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05765032","kind":"trial","name":"Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SHR-A1921 in advanced solid tumours, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., active and no longer recruiting.","summary":"Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05765032 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with 220 participants enrolled, started 2022-12-30 and due to reach its primary completion in 2025-04-30. Interventions recorded: SHR-A1921；.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05765032","url":"https://clinicaltrials.gov/study/NCT05765032"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-a1921"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05765032","phase":"1/2","setting":"An Open Label, Multicenter, Phase Ib/II Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2022-12-30","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07326566","kind":"trial","name":"Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII","aka":[],"tldr":"A phase 2 trial of Temozolomide, Silevertinib in brain and spinal cord tumours, run by Black Diamond Therapeutics, Inc., now recruiting.","summary":"Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII is a phase 2 interventional study registered as NCT07326566 by Black Diamond Therapeutics, Inc., with 162 participants planned, started 2026-05-05 and due to reach its primary completion in 2028-11. Interventions recorded: silevertinib in combination with temozolomide, temozolomide (TMZ). Conditions listed: Glioblastoma (GBM), Newly Diagnosed Glioblastoma, GBM, Glioblastoma Multiforme (GBM). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07326566","url":"https://clinicaltrials.gov/study/NCT07326566"}],"tags":["ctgov-ingest"],"related":[],"cancers":["brain-tumours","glioblastoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide","silevertinib"],"companies":["black-diamond-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07326566","phase":"2","setting":"A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII","sponsor":"Black Diamond Therapeutics, Inc.","started":"2026-05-05","startedType":"actual","enrolled":162,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04162210","kind":"trial","name":"Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple","aka":["DREAMM 3"],"tldr":"A phase 3 trial of Belantamab mafodotin in multiple myeloma, run by GlaxoSmithKline, active and no longer recruiting.","summary":"Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) is a phase 3 interventional study registered as NCT04162210 by GlaxoSmithKline, with 325 participants enrolled, started 2020-04-02 and due to reach its primary completion in 2022-09-12. Interventions recorded: Belantamab mafodotin, Pom/dex (Pomalidomide plus low dose Dexamethasone). Conditions listed: Multiple Myeloma. Results were posted on ClinicalTrials.gov in 2023; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04162210","url":"https://clinicaltrials.gov/study/NCT04162210"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["belantamab-mafodotin"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04162210","phase":"3","setting":"A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Lowdose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)","sponsor":"GlaxoSmithKline","started":"2020-04-02","startedType":"actual","yearReported":2023,"enrolled":325,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Free Survival (PFS) Based on Investigator-Assessed Response as Per International Myeloma Working Group (IMWG)","primary":true,"unit":"months","arms":[{"name":"Belantamab Mafodotin","n":218,"value":11.2,"note":"95% CI 6.4 to 14.5; Figures from the ClinicalTrials.gov results section (first posted 2023-10-06), not from a publication"},{"name":"Pomalidomide Plus Dexamethasone","n":107,"value":7,"note":"95% CI 4.6 to 10.6"}],"hr":1.03,"ci":[0.72,1.47],"p":"0.558","source":"https://clinicaltrials.gov/study/NCT04162210?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Belantamab Mafodotin","n":218,"value":24,"note":"95% CI 19.4 to 33.2; Figures from the ClinicalTrials.gov results section (first posted 2023-10-06), not from a publication"},{"name":"Pomalidomide Plus Dexamethasone","n":107,"value":22.9,"note":"95% CI 16.0 to 29.3"}],"hr":0.98,"ci":[0.73,1.3],"p":"0.440","source":"https://clinicaltrials.gov/study/NCT04162210?tab=results"},{"endpoint":"Overall Response Rate (ORR)","unit":"%","arms":[{"name":"Belantamab Mafodotin","n":218,"value":41,"note":"95% CI 34.7 to 48.1; Figures from the ClinicalTrials.gov results section (first posted 2023-10-06), not from a publication"},{"name":"Pomalidomide Plus Dexamethasone","n":107,"value":36,"note":"95% CI 26.5 to 45.4"}],"source":"https://clinicaltrials.gov/study/NCT04162210?tab=results"}]},{"id":"nct07765446","kind":"trial","name":"Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel","aka":[],"tldr":"A phase 2 trial of SIR2501 in advanced solid tumours, run by Sironax USA, Inc., now recruiting.","summary":"Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel is a phase 2 interventional study registered as NCT07765446 by Sironax USA, Inc., with 18 participants planned, started 2026-08-21 and due to reach its primary completion in 2027-12-31. Interventions recorded: SIR2501.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07765446","url":"https://clinicaltrials.gov/study/NCT07765446"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07765446","phase":"2","setting":"A Phase 2, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SIR2501 and Its Potential to Address Paclitaxel-Induced Peripheral Neuropathy","sponsor":"Sironax USA, Inc.","started":"2026-08-21","startedType":"actual","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06081959","kind":"trial","name":"Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer","aka":[],"tldr":"A phase 3 trial of Eribulin, Capecitabine, Gemcitabine and Vinorelbine in advanced solid tumours, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.","summary":"Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer is a phase 3 interventional study registered as NCT06081959 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 376 participants planned, started 2023-10-31 and due to reach its primary completion in 2026-12-31. Interventions recorded: SKB264, Eribulin, Capecitabine, Gemcitabine and Vinorelbine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06081959","url":"https://clinicaltrials.gov/study/NCT06081959"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["eribulin","capecitabine","gemcitabine","vinorelbine"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06081959","phase":"3","setting":"A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2023-10-31","startedType":"actual","enrolled":376,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04588922","kind":"trial","name":"Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML","aka":[],"tldr":"A phase 1/2 trial of Venetoclax and Azacitidine in advanced solid tumours, run by Sellas Life Sciences Group, now recruiting.","summary":"Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML is a phase 1/2 interventional study registered as NCT04588922 by Sellas Life Sciences Group, with 160 participants planned, started 2021-05-10 and due to reach its primary completion in 2026-12-30. Interventions recorded: SLS009, venetoclax and azacitidine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04588922","url":"https://clinicaltrials.gov/study/NCT04588922"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["bcl2-inhibitors","cytotoxic-chemotherapy","epigenetic-drugs","kinase-inhibitors"],"targets":[],"drugs":["venetoclax","azacitidine"],"companies":["galena-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04588922","phase":"1/2","setting":"A Phase I/IIa, Open-Label Dose Escalation and Dose Expansion Study of Intravenous GFH009 Single Agent and in Combination With Venetoclax and Azacitidine in Patients With Relapsed/Refractory Hematologic Malignancies and High-Risk Newly Diagnosed AML","sponsor":"Sellas Life Sciences Group","started":"2021-05-10","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06252649","kind":"trial","name":"Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal","aka":["CodeBreaK 301"],"tldr":"A phase 3 trial of Sotorasib, Panitumumab in colorectal cancer, run by Amgen, now recruiting.","summary":"Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation is a phase 3 interventional study registered as NCT06252649 by Amgen, with 450 participants planned, started 2024-07-17 and due to reach its primary completion in 2028-09-25. Interventions recorded: FOLFIRI Regimen, Sotorasib, Panitumumab, Bevacizumab-awwb. Conditions listed: Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06252649","url":"https://clinicaltrials.gov/study/NCT06252649"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","kras-g12c-colorectal"],"sections":[],"technologies":["kras-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["sotorasib","panitumumab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":["codebreak-300"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["CodeBreaK 301 is the first-line randomised test of sotorasib and panitumumab with FOLFIRI against FOLFIRI with or without bevacizumab in treatment-naive KRAS G12C-mutated metastatic colorectal cancer. The registry lists 450 participants, a start date of 17 July 2024, recruitment continuing and primary completion due 25 September 2028."],"nct":"NCT06252649","phase":"3","setting":"Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)","sponsor":"Amgen","started":"2024-07-17","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06127238","kind":"trial","name":"Study of ST-1898 in Advanced Renal Cell Carcinoma","aka":[],"tldr":"A phase 1/2 trial of ST-1898 tablets in renal cell carcinoma, run by Beijing Scitech-Mq Pharmaceuticals Limited, active and no longer recruiting.","summary":"Study of ST-1898 in Advanced Renal Cell Carcinoma is a phase 1/2 interventional study registered as NCT06127238 by Beijing Scitech-Mq Pharmaceuticals Limited, with 90 participants enrolled, started 2023-02-07 and due to reach its primary completion in 2025-12. Interventions recorded: ST-1898 tablets.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06127238","url":"https://clinicaltrials.gov/study/NCT06127238"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["beijing-scitech-mq-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06127238","phase":"1/2","setting":"A Phase Ib/II Study of ST-1898 to Evaluate the Efficacy and Safety in Patients With Renal Cell Carcinoma (RCC)","sponsor":"Beijing Scitech-Mq Pharmaceuticals Limited","started":"2023-02-07","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06359847","kind":"trial","name":"Study of ST-1898 in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer","aka":[],"tldr":"A phase 2 trial of ST-1898 tablets in thyroid cancer, run by Beijing Scitech-Mq Pharmaceuticals Limited, now recruiting.","summary":"Study of ST-1898 in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer is a phase 2 interventional study registered as NCT06359847 by Beijing Scitech-Mq Pharmaceuticals Limited, with 60 participants planned, started 2023-11-15 and due to reach its primary completion in 2027-12. Interventions recorded: ST-1898 tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06359847","url":"https://clinicaltrials.gov/study/NCT06359847"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["thyroid"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["beijing-scitech-mq-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06359847","phase":"2","setting":"A Multicenter, Phase II Clinical Trial to Evaluate the Efficacy and Safety of ST-1898 Tablets in Patients With Locally Advanced or Metastatic RAIR-DTC After Failure of at Least First-line TKI Systemic Therapy","sponsor":"Beijing Scitech-Mq Pharmaceuticals Limited","started":"2023-11-15","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05098132","kind":"trial","name":"Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers","aka":["SYNERGY-101"],"tldr":"A phase 1/2 trial of Pemetrexed, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Synthekine, now recruiting.","summary":"Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers is a phase 1/2 interventional study registered as NCT05098132 by Synthekine, with 364 participants planned, started 2022-01-25 and due to reach its primary completion in 2029-01. Interventions recorded: STK-012, pembrolizumab KEYTRUDA®, pemetrexed, carboplatin. Conditions listed: Advanced Solid Tumor, Non Small Cell Lung Cancer, Untreated Advanced NSCLC, 1st Line NSCLC. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05098132","url":"https://clinicaltrials.gov/study/NCT05098132"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pemetrexed","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05098132","phase":"1/2","setting":"A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects With Front-line Advanced NSCLC and Other Selected Indications","sponsor":"Synthekine","started":"2022-01-25","startedType":"actual","enrolled":364,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06191744","kind":"trial","name":"Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease ","aka":["EPCORE FL-2"],"tldr":"A phase 3 trial of Epcoritamab, Prednisone, Rituximab in follicular lymphoma, run by Genmab, active and no longer recruiting.","summary":"Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma is a phase 3 interventional study registered as NCT06191744 by Genmab, with 1095 participants enrolled, started 2024-02-05 and due to reach its primary completion in 2037-11. Interventions recorded: Epcoritamab, Prednisone, Rituximab, Lenalidomide, Doxorubicin. Conditions listed: Follicular Lymphoma (FL). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06191744","url":"https://clinicaltrials.gov/study/NCT06191744"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["monoclonal-antibody","protac-degrader","t-cell-engager"],"targets":[],"drugs":["epcoritamab","prednisone","rituximab","lenalidomide","doxorubicin","vincristine"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06191744","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)","sponsor":"Genmab","started":"2024-02-05","startedType":"actual","enrolled":1095,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05409066","kind":"trial","name":"Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease ","aka":["EPCORE FL-1"],"tldr":"A phase 3 trial of Epcoritamab, Rituximab, Lenalidomide in follicular lymphoma, run by Genmab, active and no longer recruiting.","summary":"Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma is a phase 3 interventional study registered as NCT05409066 by Genmab, with 549 participants enrolled, started 2022-09-20 and due to reach its primary completion in 2029-12. Interventions recorded: Epcoritamab, Rituximab, Lenalidomide. Conditions listed: Follicular Lymphoma (FL). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05409066","url":"https://clinicaltrials.gov/study/NCT05409066"}],"tags":["ctgov-ingest"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["monoclonal-antibody","protac-degrader","t-cell-engager"],"targets":[],"drugs":["epcoritamab","rituximab","lenalidomide"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05409066","phase":"3","setting":"A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)","sponsor":"Genmab","started":"2022-09-20","startedType":"actual","enrolled":549,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06228053","kind":"trial","name":"Study of SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer","aka":["SYNERGY-201"],"tldr":"A phase 2 trial of Enzalutamide in prostate cancer, run by Syntrix Biosystems, Inc., now recruiting.","summary":"Study of SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer is a phase 2 interventional study registered as NCT06228053 by Syntrix Biosystems, Inc., with 53 participants planned, started 2024-11-18 and due to reach its primary completion in 2027-06-30. Interventions recorded: SX-682, Enzalutamide. Conditions listed: Metastatic Castration-resistant Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06228053","url":"https://clinicaltrials.gov/study/NCT06228053"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["enzalutamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06228053","phase":"2","setting":"A Phase 2, Single-Arm Study of the CXCR1/2 Inhibitor SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer, the SYNERGY-201 Trial","sponsor":"Syntrix Biosystems, Inc.","started":"2024-11-18","startedType":"actual","enrolled":53,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04821622","kind":"trial","name":"Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC","aka":["TALAPRO-3"],"tldr":"A phase 3 trial of Talazoparib and Enzalutamide in prostate cancer, run by Pfizer, active and no longer recruiting.","summary":"Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC is a phase 3 interventional study registered as NCT04821622 by Pfizer, with 599 participants enrolled, started 2021-05-12 and due to reach its primary completion in 2026-02-18. Interventions recorded: talazoparib plus enzalutamide and Placebo plus enzalutamide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04821622","url":"https://clinicaltrials.gov/study/NCT04821622"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation","parp-inhibitor"],"targets":[],"drugs":["talazoparib","enzalutamide"],"companies":["pfizer","astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04821622-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04821622","phase":"3","setting":"TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER","sponsor":"Pfizer","started":"2021-05-12","startedType":"actual","enrolled":599,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03155191","kind":"trial","name":"Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia","aka":[],"tldr":"A phase 1/2 trial of TBI-1501 in acute lymphoblastic leukaemia, run by Takara Bio Inc., active and no longer recruiting.","summary":"Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia is a phase 1/2 interventional study registered as NCT03155191 by Takara Bio Inc., with 21 participants enrolled, started 2017-06-01 and due to reach its primary completion in 2035-03-31. Interventions recorded: TBI-1501.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03155191","url":"https://clinicaltrials.gov/study/NCT03155191"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":[],"targets":[],"drugs":["tbi-1501"],"companies":["takara-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03155191","phase":"1/2","setting":"A Multicenter Phase I/II Study for Relapsed or Refractory CD19+ B-acute Lymphoblastic Leukemia","sponsor":"Takara Bio Inc.","started":"2017-06-01","startedType":"actual","enrolled":21,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06731478","kind":"trial","name":"Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer","aka":["Destiny-Gastric05"],"tldr":"A phase 3 trial of Trastuzumab deruxtecan, Pembrolizumab and Trastuzumab in gastric & gastro-oesophageal junction cancer, run by Daiichi Sankyo, now recruiting.","summary":"Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer is a phase 3 interventional study registered as NCT06731478 by Daiichi Sankyo, with 726 participants planned, started 2025-02-27 and due to reach its primary completion in 2028-06-01. Interventions recorded: Trastuzumab Deruxtecan, pembrolizumab, Trastuzumab and Chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06731478","url":"https://clinicaltrials.gov/study/NCT06731478"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":["adc","checkpoint-inhibitor","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan","pembrolizumab","trastuzumab"],"companies":["daiichi-sankyo","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06731478","phase":"3","setting":"A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)","sponsor":"Daiichi Sankyo","started":"2025-02-27","startedType":"actual","enrolled":726,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06072612","kind":"trial","name":"Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.","aka":["BRIA-ABC"],"tldr":"A phase 3 trial of Cyclophosphamide and Retifanlimab in advanced solid tumours, run by BriaCell Therapeutics Corporation, now recruiting.","summary":"Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. is a phase 3 interventional study registered as NCT06072612 by BriaCell Therapeutics Corporation, with 404 participants planned, started 2023-12-05 and due to reach its primary completion in 2027-12. Interventions recorded: SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab and Treatment of Physician's Choice.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06072612","url":"https://clinicaltrials.gov/study/NCT06072612"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cyclophosphamide","retifanlimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06072612","phase":"3","setting":"Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer.","sponsor":"BriaCell Therapeutics Corporation","started":"2023-12-05","startedType":"actual","enrolled":404,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06284590","kind":"trial","name":"Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination With Pembrolizumab, in Unresectable Melanoma Patients","aka":[],"tldr":"A phase 2 trial of Pembrolizumab in melanoma, run by Philogen S.p.A., now recruiting.","summary":"Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination With Pembrolizumab, in Unresectable Melanoma Patients is a phase 2 interventional study registered as NCT06284590 by Philogen S.p.A., with 162 participants planned, started 2024-07-12 and due to reach its primary completion in 2028-07. Interventions recorded: L19IL2, L19TNF, L19IL2/L19TNF, KEYTRUDA®. Conditions listed: Melanoma Stage III, Melanoma Stage IV. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06284590","url":"https://clinicaltrials.gov/study/NCT06284590"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["philogen-s-p-a"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06284590","phase":"2","setting":"A Phase 2, Three-arm, Randomized Study of the Efficacy of Intratumorally Administered L19IL2 or L19TNF or L19IL2/L19TNF, All in Combination With Systemic Anti-PD1 Pembrolizumab, in Stage III and IV Unresectable Melanoma Patients With Resistance to or Progressing Upon Anti-PD1 Checkpoint Inhibitors and With Presence of Injectable Metastases","sponsor":"Philogen S.p.A.","started":"2024-07-12","startedType":"actual","enrolled":162,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03315754","kind":"trial","name":"Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer","aka":[],"tldr":"A phase 2 trial of Padeliporfin in Prostate cancer, run by Steba Biotech S.A., completed.","summary":"Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer is a phase 2 interventional study registered as NCT03315754 by Steba Biotech S.A., with 50 participants recorded, started 2017-10-02 and reaching its primary completion in 2020-11-02. Interventions recorded: TOOKAD Soluble 4 mg/kg. Conditions recorded: Localized Prostate Cancer.\n\nLinked to the drug Padeliporfin because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03315754","url":"https://clinicaltrials.gov/study/NCT03315754"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-intermediate-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["padeliporfin"],"companies":["steba-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03315754","phase":"2","setting":"Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Localized Intermediate Risk Prostate Cancer.","sponsor":"Steba Biotech S.A.","started":"2017-10-02","startedType":"actual","yearReported":2023,"enrolled":50,"enrolledBasis":"registry","outcomes":[{"endpoint":"Participants With Negative Biopsy for Gleason Score 7 (Gleason Grade 4 or 5) Prostate Cancer on 12-month Post-treatment","primary":true,"unit":"participants","arms":[{"name":"12 Months Follow up PP Group","n":44,"value":37,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-08-02), not from a publication"},{"name":"12 Months Follow up ITT Group","n":50,"value":38}],"source":"https://clinicaltrials.gov/study/NCT03315754?tab=results"}]},{"id":"nct05565417","kind":"trial","name":"Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas","aka":[],"tldr":"A phase 1/2 trial of Fruquintinib in non-small-cell lung cancer and small-cell lung cancer, run by Immunitas Therapeutics, active and no longer recruiting.","summary":"Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas is a phase 1/2 interventional study registered as NCT05565417 by Immunitas Therapeutics, with 67 participants enrolled, started 2022-11-28 and due to reach its primary completion in 2026-01. Interventions recorded: IMT-009, Fruquintinib. Conditions listed: Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer, Cutaneous Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05565417","url":"https://clinicaltrials.gov/study/NCT05565417"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","head-and-neck","cutaneous-scc","colorectal"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05565417","phase":"1/2","setting":"A Phase 1/2a, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas","sponsor":"Immunitas Therapeutics","started":"2022-11-28","startedType":"actual","enrolled":67,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06726161","kind":"trial","name":"Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC","aka":[],"tldr":"A phase 1/2 trial of RYZ801 in hepatocellular carcinoma, run by RayzeBio, Inc., now recruiting.","summary":"Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC is a phase 1/2 interventional study registered as NCT06726161 by RayzeBio, Inc., with 590 participants planned, started 2025-09-05 and due to reach its primary completion in 2030-06. Interventions recorded: RYZ801.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06726161","url":"https://clinicaltrials.gov/study/NCT06726161"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["rayzebio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06726161","phase":"1/2","setting":"Phase 1/2 Randomized, Controlled, Open-label Trial of Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ Unresectable Hepatocellular Carcinoma (HCC)","sponsor":"RayzeBio, Inc.","started":"2025-09-05","startedType":"actual","enrolled":590,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03865082","kind":"trial","name":"Study of Tilsotolimod in Combination With Nivolumab and Ipilimumab for the Treatment of Solid Tumors (ILLUMINATE-206)","aka":["ILLUMINATE-206"],"tldr":"A phase 2 trial of Nivolumab and Ipilimumab in advanced solid tumours, run by Idera Pharmaceuticals, Inc., active and no longer recruiting.","summary":"Study of Tilsotolimod in Combination With Nivolumab and Ipilimumab for the Treatment of Solid Tumors (ILLUMINATE-206) is a phase 2 interventional study registered as NCT03865082 by Idera Pharmaceuticals, Inc., with 30 participants enrolled, started 2019-10-29 and due to reach its primary completion in 2022-03. Interventions recorded: Tilsotolimod, Nivolumab and Ipilimumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03865082","url":"https://clinicaltrials.gov/study/NCT03865082"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":["idera-pharmaceuticals","bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03865082","phase":"2","setting":"Study of Tilsotolimod in Combination With Nivolumab and Ipilimumab for the Treatment of Solid Tumors","sponsor":"Idera Pharmaceuticals, Inc.","started":"2019-10-29","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05948475","kind":"trial","name":"Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma","aka":[],"tldr":"A phase 3 trial of Tinengotinib in biliary tract cancer, run by TransThera Sciences (Nanjing), Inc., active and no longer recruiting.","summary":"Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma is a phase 3 interventional study registered as NCT05948475 by TransThera Sciences (Nanjing), Inc., with 200 participants enrolled, started 2023-12-20 and due to reach its primary completion in 2026-12. Interventions recorded: Tinengotinib 8 mg, Tinengotinib 10 mg and Physician's Choice.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05948475","url":"https://clinicaltrials.gov/study/NCT05948475"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["tinengotinib"],"companies":["transthera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05948475","phase":"3","setting":"A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib VS Physician's Choice in Subjects With FGFR-altered, Chemotherapy- and FGFR Inhibitor-Cholangiocarcinoma","sponsor":"TransThera Sciences (Nanjing), Inc.","started":"2023-12-20","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06704620","kind":"trial","name":"Study of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist（Diphenhydramine）in Advanced and Metastatic Non-Small Cell Lung Can","aka":[],"tldr":"A phase 3 trial of tislelizumab, pemetrexed, carboplatin and cisplatin in lung cancer, run by Tianjin Medical University Cancer Institute and Hospital, not yet recruiting.","summary":"Study of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist（Diphenhydramine）in Advanced and Metastatic Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT06704620 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 430 participants, started 2024-12 and due to reach its primary completion in 2026-11. Interventions recorded: Diphenhydramine; Tislelizumab; Pemetrexed; Albumin paclitaxel; Carboplatin; Cisplatin. Conditions listed: Advanced and Metastatic NSCLC. Primary outcome: PFS. Lung eligibility wording from the registry: \"Patients diagnosed with stage IIIB-IV NSCLC by imaging, tissue and/or cytology (according to AJCC 9th edition), or primary stage IIIB-IV NSCLC that relapses after surgery (if adjuvant therapy has been used, the drug must be discontinued for more than 6 months);Patients with IIIB/C are unable to unde\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06704620","url":"https://clinicaltrials.gov/study/NCT06704620"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["tislelizumab","pemetrexed","carboplatin","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06704620","phase":"3","setting":"Safety and Effectiveness of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist（Diphenhydramine）in Advanced and Metastatic Non-Small Cell Lung Cancer: A Prospective, Randomized-controlled, Multi-center, Open-label, Phase-III Trial.","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2024-12","startedType":"estimated","enrolled":430,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03967977","kind":"trial","name":"Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma","aka":[],"tldr":"A phase 3 trial of Tislelizumab, Cisplatin, Gemcitabine and Carboplatin in bladder & urothelial cancer, run by BeiGene, active and no longer recruiting.","summary":"Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma is a phase 3 interventional study registered as NCT03967977 by BeiGene, with 420 participants enrolled, started 2019-05-29 and due to reach its primary completion in 2027-06-30. Interventions recorded: Tislelizumab, Placebo, Cisplatin, Gemcitabine Hydrochloride and Carboplatin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03967977","url":"https://clinicaltrials.gov/study/NCT03967977"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["tislelizumab","cisplatin","gemcitabine","carboplatin"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03967977","phase":"3","setting":"A Phase 3, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of Either Cisplatin or Carboplatin +Gemcitabine + Tislelizumab Compared With Either Cisplatin or Carboplatin + Gemcitabine + Placebo as First-line Treatment for Patients With Locally Advanced or Metastatic Urothelial Carcinoma","sponsor":"BeiGene","started":"2019-05-29","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04843098","kind":"trial","name":"Study of TL117 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","aka":[],"tldr":"A phase 1/2 trial of Paclitaxel / nab-paclitaxel in head and neck squamous cell carcinoma, run by Suzhou Junde Biotechnology Co., Ltd, active and no longer recruiting.","summary":"Study of TL117 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma is a phase 1/2 interventional study registered as NCT04843098 by Suzhou Junde Biotechnology Co., Ltd, with 108 participants planned, started 2021-05-26 and due to reach its primary completion in 2024-11-20. Interventions recorded: TL117, Paclitaxel. Conditions listed: Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04843098","url":"https://clinicaltrials.gov/study/NCT04843098"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04843098","phase":"1/2","setting":"Phase I/II Study of the PI3K Inhibitor TL117 Alone and in Combination With Paclitaxel in Patients With Relapsed/Metastatic Squamous Cell Carcinoma of the Head and Neck","sponsor":"Suzhou Junde Biotechnology Co., Ltd","started":"2021-05-26","startedType":"actual","enrolled":108,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07100730","kind":"trial","name":"Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma","aka":["IPAX-3"],"tldr":"A phase 3 trial of TLX-101-Tx + Lomustine in glioma & glioblastoma, run by Telix Pharmaceuticals (Innovations) Pty Limited, now recruiting.","summary":"Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma is a phase 3 interventional study registered as NCT07100730 by Telix Pharmaceuticals (Innovations) Pty Limited, with 50 participants planned, started 2025-11-02 and due to reach its primary completion in 2027-07. Interventions recorded: TLX-101-Tx + Lomustine and TLX101-Tx.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07100730","url":"https://clinicaltrials.gov/study/NCT07100730"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["telix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07100730","phase":"3","setting":"A Global, Multicenter, Prospective, Controlled, Open-Label Pivotal Study of Iodofalan (131I) Solution for Injection (TLX101-Tx) Plus Lomustine Versus Lomustine Alone in Patients With Radiographically Confirmed Recurrent Glioblastoma at First Recurrence (IPAX BrIGHT [IPAX-3])","sponsor":"Telix Pharmaceuticals (Innovations) Pty Limited","started":"2025-11-02","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05887492","kind":"trial","name":"Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Tango Therapeutics, Inc., active and no longer recruiting.","summary":"Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors is a phase 1/2 interventional study registered as NCT05887492 by Tango Therapeutics, Inc., with 126 participants planned, started 2023-06-12 and due to reach its primary completion in 2026-09. Interventions recorded: TNG260, Pembrolizumab. Conditions listed: Non Small Cell Lung Cancer, Solid Tumors, Adult, Lung Cancer, Lung Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05887492","url":"https://clinicaltrials.gov/study/NCT05887492"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","tng260"],"companies":["tango-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05887492","phase":"1/2","setting":"A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination With an Anti-PD-1 Antibody In Patients With STK11 Mutated Advanced Solid Tumors","sponsor":"Tango Therapeutics, Inc.","started":"2023-06-12","startedType":"actual","enrolled":126,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07022483","kind":"trial","name":"Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer","aka":["ENGOT-en30"],"tldr":"A phase 3 trial of Trastuzumab deruxtecan in endometrial cancer, run by Daiichi Sankyo, now recruiting.","summary":"Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer is a phase 3 interventional study registered as NCT07022483 by Daiichi Sankyo, with 710 participants planned, started 2025-09-30 and due to reach its primary completion in 2032-03-23. Interventions recorded: Trastuzumab Deruxtecan, Chemotherapy. Conditions listed: Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07022483","url":"https://clinicaltrials.gov/study/NCT07022483"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07022483","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy With or Without Radiotherapy as Adjuvant Treatment for HER2-Expressing (IHC 3+/2+) Endometrial Cancer (DESTINY-Endometrial02/ GOG-3122/ ENGOT-en30/GINECO)","sponsor":"Daiichi Sankyo","started":"2025-09-30","startedType":"actual","enrolled":710,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06819007","kind":"trial","name":"Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-","aka":["ENGOT-ov89"],"tldr":"A phase 3 trial of Trastuzumab deruxtecan, Bevacizumab in ovarian cancer, run by Daiichi Sankyo, now recruiting.","summary":"Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01) is a phase 3 interventional study registered as NCT06819007 by Daiichi Sankyo, with 582 participants planned, started 2025-03-19 and due to reach its primary completion in 2028-11-01. Interventions recorded: Trastuzumab Deruxtecan, Bevacizumab. Conditions listed: Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06819007","url":"https://clinicaltrials.gov/study/NCT06819007"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["adc","antiangiogenic","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan","bevacizumab"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06819007","phase":"3","setting":"A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01/ENGOT-ov89/GEICO144- O/GOG-3112/APGOT-OV13)","sponsor":"Daiichi Sankyo","started":"2025-03-19","startedType":"actual","enrolled":582,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06899126","kind":"trial","name":"Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer","aka":["DESTINY-Lung06"],"tldr":"A phase 3 trial of Trastuzumab deruxtecan, Pembrolizumab, Pemetrexed in non-small-cell lung cancer and small-cell lung cancer, run by Daiichi Sankyo, now recruiting.","summary":"Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT06899126 by Daiichi Sankyo, with 686 participants planned, started 2025-10-24 and due to reach its primary completion in 2030-04-24. Interventions recorded: Trastuzumab Deruxtecan, pembrolizumab, Pemetrexed, Platinum Chemotherapy. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06899126","url":"https://clinicaltrials.gov/study/NCT06899126"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","her2-mutant-nsclc"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan","pembrolizumab","pemetrexed"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06899126","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)","sponsor":"Daiichi Sankyo","started":"2025-10-24","startedType":"actual","enrolled":686,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06431633","kind":"trial","name":"Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free.","aka":["ARIAN"],"tldr":"A phase 3 trial of zimberelimab, sacituzumab govitecan, cisplatin and carboplatin in lung cancer, run by Fundación GECP, now recruiting.","summary":"Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free. is a phase 3, randomised interventional study registered as NCT06431633 by Fundación GECP, with a registry enrolment figure of 129 participants, started 2025-02-04 and due to reach its primary completion in 2031-11-30. Interventions recorded: Zimberelimab; Sacituzumab govitecan; Cisplatin; Carboplatin. Conditions listed: Lung Diseases; Carcinoma, Non-Small-Cell Lung; Resectable Lung Non-Small Cell Carcinoma. Primary outcome: Disease free survival. Lung eligibility wording from the registry: \"Patients diagnosed of primary non-small cell lung cancer, histologically confirmed\". Sites: Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06431633","url":"https://clinicaltrials.gov/study/NCT06431633"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["zimberelimab","sacituzumab-govitecan","cisplatin","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06431633","phase":"3","setting":"A Phase III Clinical Trial of Adjuvant Treatment With Sacituzumab and Zimberelimab for Stage IB-IIIA-IIIB(N2) Previously Resected (R0) Non-small Cell Lung Cancer Patients That Did Not Achieve Pathological Complete Response After Neoadjuvant treatment_ARIAN","sponsor":"Fundación GECP","started":"2025-02-04","startedType":"actual","enrolled":129,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05578326","kind":"trial","name":"Study of Trilaciclib and Lurbinectidin","aka":[],"tldr":"A phase 2 trial of trilaciclib and lurbinectedin in lung cancer, run by UNC Lineberger Comprehensive Cancer Center, now recruiting.","summary":"Study of Trilaciclib and Lurbinectidin is a phase 2, interventional study registered as NCT05578326 by UNC Lineberger Comprehensive Cancer Center, with a registry enrolment figure of 30 participants, started 2022-10-12 and due to reach its primary completion in 2026-12-25. Interventions recorded: Trilaciclib; Lurbinectedin. Conditions listed: Lung Cancer; Small-cell Lung Cancer. Primary outcome: The proportion of grade 4 neutropenia; The duration of grade 4 neutropenia. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05578326","url":"https://clinicaltrials.gov/study/NCT05578326"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["trilaciclib","lurbinectedin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05578326","phase":"2","setting":"Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer","sponsor":"UNC Lineberger Comprehensive Cancer Center","started":"2022-10-12","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06260774","kind":"trial","name":"Study of TTX-MC138 in Subjects With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of TTX-MC138 in advanced solid tumours, run by TransCode Therapeutics, active and no longer recruiting.","summary":"Study of TTX-MC138 in Subjects With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06260774 by TransCode Therapeutics, with 16 participants enrolled, started 2024-09-05 and due to reach its primary completion in 2025-09-30. Interventions recorded: TTX-MC138.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06260774","url":"https://clinicaltrials.gov/study/NCT06260774"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06260774","phase":"1/2","setting":"A Phase 1/2 Multicenter, Open-Label, Dose-escalation and Expansion Study of TTX-MC138 in Subjects With Advanced Solid Tumors","sponsor":"TransCode Therapeutics","started":"2024-09-05","startedType":"actual","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05784688","kind":"trial","name":"Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in head and neck squamous cell carcinoma and colorectal cancer, run by TiumBio Co., Ltd., now recruiting.","summary":"Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05784688 by TiumBio Co., Ltd., with 140 participants planned, started 2023-03-10 and due to reach its primary completion in 2026-12. Interventions recorded: TU2218 + KEYTRUDA® (Pembrolizumab). Conditions listed: Solid Tumor, Biliary Tract Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05784688","url":"https://clinicaltrials.gov/study/NCT05784688"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["tiumbio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05784688","phase":"1/2","setting":"A Phase 1b/2a Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of TU2218, an Oral TGFβR Serine/Threonine Kinase Inhibitor, Administered in Combination With Pembrolizumab in Patients With Advanced Solid Tumors","sponsor":"TiumBio Co., Ltd.","started":"2023-03-10","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07736937","kind":"trial","name":"Study of TUB-040 Given With Standard Ovarian Cancer Drugs in Patients With Fast-growing Ovarian Cancer","aka":[],"tldr":"A phase 1/2 trial of TUB-040 + Carbo + BEV in ovarian cancer, run by Tubulis GmbH, now recruiting.","summary":"Study of TUB-040 Given With Standard Ovarian Cancer Drugs in Patients With Fast-growing Ovarian Cancer is a phase 1/2 interventional study registered as NCT07736937 by Tubulis GmbH, with 72 participants planned, started 2026-03-30 and due to reach its primary completion in 2028-03. Interventions recorded: TUB-040 + Carbo + BEV.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07736937","url":"https://clinicaltrials.gov/study/NCT07736937"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["tubulis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07736937","phase":"1/2","setting":"A Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of TUB-040, in Combination With Standard Ovarian Cancer Drugs in Patients With High-grade Epithelial Serous or Endometrioid Epithelial Ovarian Cancer OC)","sponsor":"Tubulis GmbH","started":"2026-03-30","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07806773","kind":"trial","name":"Study of TUB-040 in Participants With Unresectable or Metastatic Nonsquamous Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Tubulis GmbH, not yet recruiting.","summary":"Study of TUB-040 in Participants With Unresectable or Metastatic Nonsquamous Non-small Cell Lung Cancer is a phase 2, randomised interventional study registered as NCT07806773 by Tubulis GmbH, with a registry enrolment figure of 80 participants, started 2026-11 and due to reach its primary completion in 2029-05. Interventions recorded: TUB-040. Conditions listed: NSCLC; Non Small Cell Lung Cancer. Primary outcome: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs); Overall Response Rate (ORR). Lung eligibility wording from the registry: \"Mixed histology NSCLC (eg, small cell lung cancer/NSCLC) or histology other than adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07806773","url":"https://clinicaltrials.gov/study/NCT07806773"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["tubulis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07806773","phase":"2","setting":"A Randomized, Open-label, Phase 2a Dose Optimization Study of TUB-040 (a NaPi2b Antibody-drug Conjugate) in Participants With Unresectable or Metastatic Nonsquamous Non-small Cell Lung Cancer","sponsor":"Tubulis GmbH","started":"2026-11","startedType":"estimated","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06950086","kind":"trial","name":"Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of TYK-00540 in HR-positive / HER2-negative breast cancer, run by TYK Medicines, Inc, now recruiting.","summary":"Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06950086 by TYK Medicines, Inc, with 180 participants planned, started 2024-01-02 and due to reach its primary completion in 2026-09. Interventions recorded: TYK-00540.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06950086","url":"https://clinicaltrials.gov/study/NCT06950086"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["tyk-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06950086","phase":"1/2","setting":"A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of the CDK2/4/6 Inhibitor TYK-00540 Tablets in Patients With Advanced Solid Tumors","sponsor":"TYK Medicines, Inc","started":"2024-01-02","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02899052","kind":"trial","name":"Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)","aka":[],"tldr":"A phase 2 trial of Carfilzomib, Venetoclax, Dexamethasone in multiple myeloma, run by AbbVie, active and no longer recruiting.","summary":"Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM) is a phase 2 interventional study registered as NCT02899052 by AbbVie, with 120 participants planned, started 2017-01-19 and due to reach its primary completion in 2027-06. Interventions recorded: Carfilzomib, Venetoclax, Dexamethasone. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02899052","url":"https://clinicaltrials.gov/study/NCT02899052"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["antiemetic-therapy","bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["carfilzomib","venetoclax","dexamethasone"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02899052","phase":"2","setting":"A Phase 2, Open-Label, Multi-Center Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma","sponsor":"AbbVie","started":"2017-01-19","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03069469","kind":"trial","name":"Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor","aka":[],"tldr":"A phase 1/2 trial of Vimseltinib in tenosynovial giant cell tumour, run by Deciphera Pharmaceuticals, LLC, active and no longer recruiting.","summary":"Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor is a phase 1/2 interventional study registered as NCT03069469 by Deciphera Pharmaceuticals, LLC, with 120 participants planned, started 2017-02-16 and due to reach its primary completion in 2028-08. Interventions recorded: Vimseltinib. Conditions listed: Advanced Malignant Neoplasm, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath, Tenosynovial Giant Cell Tumor. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03069469","url":"https://clinicaltrials.gov/study/NCT03069469"}],"tags":["ctgov-ingest"],"related":[],"cancers":["tenosynovial-giant-cell-tumour"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["vimseltinib"],"companies":["deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03069469","phase":"1/2","setting":"A Multicenter Phase 1/2, Open-Label Study of DCC-3014 to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor","sponsor":"Deciphera Pharmaceuticals, LLC","started":"2017-02-16","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06535607","kind":"trial","name":"Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors","aka":["eVOLVE-02"],"tldr":"A phase 2 trial of Cisplatin, Carboplatin, Paclitaxel / nab-paclitaxel in cervical cancer and head and neck squamous cell carcinoma, run by AstraZeneca, now recruiting.","summary":"Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors is a phase 2 interventional study registered as NCT06535607 by AstraZeneca, with 257 participants planned, started 2024-08-22 and due to reach its primary completion in 2028-11-30. Interventions recorded: Volrustomig, Cisplatin, Carboplatin, Paclitaxel, 5-FU. Conditions listed: Sub-study 1 Cervical Cancer (Volrustomig Monotherapy), Sub-study 2 Head and Neck Squamous Cell Carcinoma (Volrustomig Monotherapy), Sub-study 3 Head and Neck Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy), Sub-study 4 Esophageal Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06535607","url":"https://clinicaltrials.gov/study/NCT06535607"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","head-and-neck","mesothelioma"],"sections":[],"technologies":[],"targets":[],"drugs":["cisplatin","carboplatin","paclitaxel","flot"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06535607","phase":"2","setting":"A Phase II, Multi-Center Study to Evaluate the Efficacy and Safety of Volrustomig as Monotherapy or in Combination With Anti-cancer Agents in Participants With Advanced/Metastatic Solid Tumors","sponsor":"AstraZeneca","started":"2024-08-22","startedType":"actual","enrolled":257,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06079671","kind":"trial","name":"Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)","aka":["eVOLVECervical"],"tldr":"A phase 3 trial of Volrustomig in cervical cancer, run by AstraZeneca, now recruiting.","summary":"Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical) is a phase 3 interventional study registered as NCT06079671 by AstraZeneca, with 800 participants planned, started 2023-09-22 and due to reach its primary completion in 2027-11-26. Interventions recorded: Volrustomig.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06079671","url":"https://clinicaltrials.gov/study/NCT06079671"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cervical","locally-advanced-cervical-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06079671","phase":"3","setting":"A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)","sponsor":"AstraZeneca","started":"2023-09-22","startedType":"actual","enrolled":800,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05425940","kind":"trial","name":"Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer","aka":["STELLAR-303"],"tldr":"A phase 3 trial of Zanzalintinib, Atezolizumab, Regorafenib in colorectal cancer, run by Exelixis, active and no longer recruiting.","summary":"Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer is a phase 3 interventional study registered as NCT05425940 by Exelixis, with 901 participants enrolled, started 2022-09-07 and due to reach its primary completion in 2026-06-16. Interventions recorded: XL092, Atezolizumab, Regorafenib. Conditions listed: Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05425940","url":"https://clinicaltrials.gov/study/NCT05425940"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["zanzalintinib","atezolizumab","regorafenib"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05425940-lancet-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05425940","phase":"3","setting":"A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer","sponsor":"Exelixis","started":"2022-09-07","startedType":"actual","enrolled":901,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06799637","kind":"trial","name":"Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments","aka":[],"tldr":"A phase 1/2 trial of XNW28012 in pancreatic ductal adenocarcinoma, ovarian cancer and cervical cancer, run by Evopoint Biosciences Inc., now recruiting.","summary":"Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments is a phase 1/2 interventional study registered as NCT06799637 by Evopoint Biosciences Inc., with 350 participants planned, started 2023-12-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: XNW28012.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06799637","url":"https://clinicaltrials.gov/study/NCT06799637"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","ovarian","cervical"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["evopoint-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06799637","phase":"1/2","setting":"A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Efficacy of XNW28012 in Subjects With Advanced Solid Tumors","sponsor":"Evopoint Biosciences Inc.","started":"2023-12-01","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07823049","kind":"trial","name":"Study of XNW28012 in Subjects With Metastatic Pancreatic Cancer Who Received Prior Systemic Therapy","aka":[],"tldr":"A phase 3 trial of XNW28012 for injection in pancreatic ductal adenocarcinoma, run by Evopoint Biosciences Inc., now recruiting.","summary":"Study of XNW28012 in Subjects With Metastatic Pancreatic Cancer Who Received Prior Systemic Therapy is a phase 3 interventional study registered as NCT07823049 by Evopoint Biosciences Inc., with 226 participants planned, started 2025-07-08 and due to reach its primary completion in 2027-05-31. Interventions recorded: XNW28012 for injection and XNW28012 Mimetic for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07823049","url":"https://clinicaltrials.gov/study/NCT07823049"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["evopoint-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07823049","phase":"3","setting":"A Randomized, Double-blind, Multicenter Phase III Clinical Study Comparing XNW28012 Versus Placebo in Combination With Best Supportive Care in Patients With Metastatic Pancreatic Cancer Who Have Received Prior Systemic Therapy","sponsor":"Evopoint Biosciences Inc.","started":"2025-07-08","startedType":"actual","enrolled":226,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06702995","kind":"trial","name":"Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer","aka":[],"tldr":"A phase 1/2 trial of XNW5004, Enzalutamide in prostate cancer, run by Evopoint Biosciences Inc., now recruiting.","summary":"Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer is a phase 1/2 interventional study registered as NCT06702995 by Evopoint Biosciences Inc., with 307 participants planned, started 2023-04-19 and due to reach its primary completion in 2026-05-13. Interventions recorded: XNW5004, enzalutamide. Conditions listed: Metastatic Castrate-Resistant Prostate Cancer, mCRPC (Metastatic Castration-resistant Prostate Cancer). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06702995","url":"https://clinicaltrials.gov/study/NCT06702995"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["xnw5004","enzalutamide"],"companies":["evopoint-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06702995","phase":"1/2","setting":"A Phase Ib/II Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Failed Prior Novel Hormone Therapy","sponsor":"Evopoint Biosciences Inc.","started":"2023-04-19","startedType":"actual","enrolled":307,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06580301","kind":"trial","name":"Study of YK012 in B-cell Acute Lymphoblastic Leukemia","aka":[],"tldr":"A phase 1/2 trial of YK012 in acute lymphoblastic leukaemia, run by Excyte Biopharma Ltd, now recruiting.","summary":"Study of YK012 in B-cell Acute Lymphoblastic Leukemia is a phase 1/2 interventional study registered as NCT06580301 by Excyte Biopharma Ltd, with 46 participants planned, started 2024-09-25 and due to reach its primary completion in 2026-12-31. Interventions recorded: YK012.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06580301","url":"https://clinicaltrials.gov/study/NCT06580301"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06580301","phase":"1/2","setting":"An Open-Label, Multi-Center, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YK012 in Participants With B-cell Acute Lymphoblastic Leukemia","sponsor":"Excyte Biopharma Ltd","started":"2024-09-25","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06082167","kind":"trial","name":"Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","aka":["STELLAR-305"],"tldr":"A phase 2/3 trial testing Zanzalintinib in head and neck squamous cell carcinoma, active and no longer recruiting.","summary":"Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma is a phase 2/3 interventional study registered as NCT06082167, led by Exelixis with Merck Sharp & Dohme, and active but no longer recruiting on the registry. Official title: A Phase 2/3, Randomised, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. Planned enrolment is 600 participants (estimated). The study started in 2024-06-07 and primary completion is expected in 2028-08. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06082167","url":"https://clinicaltrials.gov/study/NCT06082167"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["zanzalintinib"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06082167","phase":"2/3","setting":"A Phase 2/3, Randomized, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","sponsor":"Exelixis","started":"2024-06-07","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06840483","kind":"trial","name":"Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer","aka":[],"tldr":"A phase 2 trial of Zelenectide pevedotin in advanced solid tumours, run by BicycleTx Limited, active and no longer recruiting.","summary":"Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer is a phase 2 interventional study registered as NCT06840483 by BicycleTx Limited, with 66 participants enrolled, started 2025-03-03 and due to reach its primary completion in 2028-06-30. Interventions recorded: Zelenectide pevedotin (BT8009).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06840483","url":"https://clinicaltrials.gov/study/NCT06840483"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["peptide-drug-conjugate"],"targets":[],"drugs":["zelenectide-pevedotin"],"companies":["bicycle-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06840483","phase":"2","setting":"Phase 2 Study of Zelenectide Pevedotin in Participants With NECTIN4 Amplified Advanced Breast Cancer","sponsor":"BicycleTx Limited","started":"2025-03-03","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06558227","kind":"trial","name":"Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma","aka":[],"tldr":"A phase 2 trial of Bevacizumab, Sintilimab in hepatocellular carcinoma, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, now recruiting.","summary":"Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma is a phase 2 interventional study registered as NCT06558227 by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, with 90 participants planned, started 2024-10-24 and due to reach its primary completion in 2026-09. Interventions recorded: ZG005 for Injection, Bevacizumab, Sintilimab, Bevacizumab. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06558227","url":"https://clinicaltrials.gov/study/NCT06558227"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","monoclonal-antibody"],"targets":[],"drugs":["bevacizumab","sintilimab"],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06558227","phase":"2","setting":"A Multicenter, Randomized, Open-label Phase II Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab for First-line Treatment of Advanced Hepatocellular Carcinoma","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","started":"2024-10-24","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06903377","kind":"trial","name":"Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of Gecacitinib in non-small-cell lung cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, now recruiting.","summary":"Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer is a phase 1/2 interventional study registered as NCT06903377 by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, with 50 participants planned, started 2025-05-23 and due to reach its primary completion in 2027-04. Interventions recorded: ZG005 for Injection and Gecacitinib Hydrochloride Tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06903377","url":"https://clinicaltrials.gov/study/NCT06903377"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["gecacitinib"],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06903377","phase":"1/2","setting":"A Multicenter, Open-label, Dose-Escalation and Dose-Expansion Phase I/II Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","started":"2025-05-23","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07080216","kind":"trial","name":"Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer","aka":[],"tldr":"A phase 1/2 trial of Bevacizumab in cervical cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, now recruiting.","summary":"Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer is a phase 1/2 interventional study registered as NCT07080216 by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, with 120 participants planned, started 2025-09-23 and due to reach its primary completion in 2027-08. Interventions recorded: ZG005, Gecacitinib, Bevacizumab. Conditions listed: Cervical Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07080216","url":"https://clinicaltrials.gov/study/NCT07080216"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["bevacizumab"],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07080216","phase":"1/2","setting":"A Multicenter, Open-label, Dose-finding and Dose-expansion Phase I/II Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","started":"2025-09-23","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06883526","kind":"trial","name":"Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma","aka":[],"tldr":"A phase 1/2 trial of Gecacitinib in non-Hodgkin lymphoma, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, now recruiting.","summary":"Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma is a phase 1/2 interventional study registered as NCT06883526 by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, with 60 participants planned, started 2025-05-16 and due to reach its primary completion in 2027-04. Interventions recorded: ZG005 for Injection and Gecacitinib Hydrochloride Tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06883526","url":"https://clinicaltrials.gov/study/NCT06883526"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["gecacitinib"],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06883526","phase":"1/2","setting":"A Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Phase I/II Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","started":"2025-05-16","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06927687","kind":"trial","name":"Study of ZG005 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 2 trial of ZG005 for Injection in advanced solid tumours, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, active and no longer recruiting.","summary":"Study of ZG005 in Patients With Advanced Solid Tumors is a phase 2 interventional study registered as NCT06927687 by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, with 50 participants enrolled, started 2025-06-13 and due to reach its primary completion in 2027-05. Interventions recorded: ZG005 for Injection.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06927687","url":"https://clinicaltrials.gov/study/NCT06927687"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06927687","phase":"2","setting":"A Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of ZG005 in Patients With Advanced Solid Tumors","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","started":"2025-06-13","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05978284","kind":"trial","name":"Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma","aka":[],"tldr":"A phase 1/2 trial of ZG006 in small-cell lung cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, now recruiting.","summary":"Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma is a phase 1/2 interventional study registered as NCT05978284 by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, with 54 participants planned, started 2023-10-27 and due to reach its primary completion in 2026-09. Interventions recorded: ZG006. Conditions listed: Small Cell Lung Cancer, Neuroendocrine Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05978284","url":"https://clinicaltrials.gov/study/NCT05978284"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["zg006"],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05978284","phase":"1/2","setting":"A Phase 1/2 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","started":"2023-10-27","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06938880","kind":"trial","name":"Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ZGGS18 for Injection in advanced solid tumours, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, now recruiting.","summary":"Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06938880 by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, with 60 participants planned, started 2025-05-20 and due to reach its primary completion in 2027-05. Interventions recorded: ZGGS18 for Injection and ZG005 for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06938880","url":"https://clinicaltrials.gov/study/NCT06938880"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06938880","phase":"1/2","setting":"A Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors, Including Cervical Cancer, Hepatocellular Carcinoma, Neuroendocrine Tumors, and Lung Cancer","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","started":"2025-05-20","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05584800","kind":"trial","name":"Study of ZGGS18 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ZGGS18 for Injection in advanced solid tumours, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, now recruiting.","summary":"Study of ZGGS18 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05584800 by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, with 222 participants planned, started 2022-11-15 and due to reach its primary completion in 2026-11-01. Interventions recorded: ZGGS18 for Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05584800","url":"https://clinicaltrials.gov/study/NCT05584800"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05584800","phase":"1/2","setting":"A Phase I/II Dose Escalation, Tolerability, Safety, Pharmacokinetics and Multiple Cohort Expansion Study of ZGGS18 in Patients With Advanced Solid Tumors","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","started":"2022-11-15","startedType":"actual","enrolled":222,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07258121","kind":"trial","name":"Study of ZGGS34 in Participants With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ZG006 in advanced solid tumours, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, now recruiting.","summary":"Study of ZGGS34 in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT07258121 by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, with 400 participants planned, started 2025-12-31 and due to reach its primary completion in 2028-12. Interventions recorded: ZG006.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07258121","url":"https://clinicaltrials.gov/study/NCT07258121"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["zg006"],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07258121","phase":"1/2","setting":"A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZGGS34 in Participants With Advanced Solid Tumors","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","started":"2025-12-31","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07805954","kind":"trial","name":"Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mut","aka":["RASolute 309"],"tldr":"A phase 3 trial of Daraxonrasib, Gemcitabine, Paclitaxel / nab-paclitaxel in pancreatic ductal adenocarcinoma, run by Revolution Medicines, Inc., now recruiting.","summary":"Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma is a phase 3 interventional study registered as NCT07805954 by Revolution Medicines, Inc., with 400 participants planned, started 2026-08-28 and due to reach its primary completion in 2029-03. Interventions recorded: daraxonrasib, gemcitabine, nab-paclitaxel, zoldonrasib. Conditions listed: Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07805954","url":"https://clinicaltrials.gov/study/NCT07805954"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","kras-inhibitors"],"targets":[],"drugs":["daraxonrasib","gemcitabine","paclitaxel","zoldonrasib"],"companies":["revolution-medicines"],"institutions":[],"pathways":[],"terms":["pancreatic-trials-open-today","kras-mutation-subtypes"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["RASolute 309 (registry, 24 September 2026): phase 3, open-label, zoldonrasib plus daraxonrasib against gemcitabine and nab-paclitaxel as first-line treatment for metastatic KRAS G12D-mutated pancreatic adenocarcinoma; 400 participants (estimated), recruiting, started 28 August 2026, primary completion March 2029; United States sites only so far."],"nct":"NCT07805954","phase":"3","setting":"A Phase 3, Randomized, Open-Label Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Patients With Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma","sponsor":"Revolution Medicines, Inc.","started":"2026-08-28","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07621718","kind":"trial","name":"Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-muta","aka":["RASolute 305"],"tldr":"A phase 3 trial of Zoldonrasib, CAPOX, FLOT in pancreatic ductal adenocarcinoma, run by Revolution Medicines, Inc., now recruiting.","summary":"Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 ) is a phase 3 interventional study registered as NCT07621718 by Revolution Medicines, Inc., with 670 participants planned, started 2026-05-22 and due to reach its primary completion in 2028-12-30. Interventions recorded: Zoldonrasib, Placebo, Oxaliplatin, Leucovorin (Calcium Folinate), 5-Fluorouracil. Conditions listed: Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07621718","url":"https://clinicaltrials.gov/study/NCT07621718"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","kras-inhibitors"],"targets":[],"drugs":["zoldonrasib","capox","flot","leucovorin","folfiri","gemcitabine"],"companies":["revolution-medicines"],"institutions":[],"pathways":[],"terms":["pancreatic-trials-open-today","kras-mutation-subtypes"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["RASolute 305 (registry, 24 September 2026): phase 3, double-blind, investigator's choice of modified FOLFIRINOX or gemcitabine plus nab-paclitaxel with or without zoldonrasib as first-line treatment for metastatic KRAS G12D-mutated pancreatic adenocarcinoma; 670 participants (estimated), recruiting, started 22 May 2026, primary completion December 2028; United States sites only so far."],"nct":"NCT07621718","phase":"3","setting":"RASolute 305: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (Modified FOLFIRINOX or Gemcitabine Plus Nab-Paclitaxel) With or Without Zoldonrasib (RMC-9805) as First-line Treatment in Patients With Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma","sponsor":"Revolution Medicines, Inc.","started":"2026-05-22","startedType":"actual","enrolled":670,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02945033","kind":"trial","name":"Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk","aka":["ASPIK French"],"tldr":"A phase 3 trial in colorectal cancer, run by University Hospital, Rouen, active but no longer recruiting.","summary":"Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk is a phase 3, randomised interventional study registered as NCT02945033 by University Hospital, Rouen, with a registry enrolment figure of 264 participants, started 2018-07-12 and due to reach its primary completion in 2028-07. Interventions recorded: aspirin intake; placebo intake; Surgical resection of colonic adenocarcinoma stage III or II high risk; Molecular analysis of exon 9 and 20 of PI3K; blood intake. Conditions listed: Colorectal Cancer. Primary outcome: Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first. Colorectal eligibility wording from the registry: \"* Colonic adenocarcinoma stage III\". Sites: France. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02945033","url":"https://clinicaltrials.gov/study/NCT02945033"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02945033","phase":"3","setting":"French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation","sponsor":"University Hospital, Rouen","started":"2018-07-12","startedType":"actual","enrolled":264,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06093672","kind":"trial","name":"Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera","aka":[],"tldr":"A phase 3 trial testing Givinostat in myeloproliferative neoplasms, now recruiting.","summary":"Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera is a phase 3 interventional study registered as NCT06093672, led by Italfarmaco with PPD Development, LP, and recruiting on the registry. Official title: Randomised, Open-label, Multicenter Phase 3 Study to Assess the Efficacy and Safety of GIVinostat Versus Hydroxyurea IN JAK2V617F-positive High-risk Polycythemia Vera Patients: the GIV-IN PV TRIAL. Planned enrolment is 220 participants (estimated). The study started in 2024-03-26 and primary completion is expected in 2026-07. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06093672","url":"https://clinicaltrials.gov/study/NCT06093672"}],"tags":["ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","polycythaemia-vera"],"sections":[],"technologies":[],"targets":[],"drugs":["givinostat"],"companies":["italfarmaco"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06093672","phase":"3","setting":"Randomized, Open-label, Multicenter Phase 3 Study to Assess the Efficacy and Safety of GIVinostat Versus Hydroxyurea IN JAK2V617F-positive High-risk Polycythemia Vera Patients: the GIV-IN PV TRIAL","sponsor":"Italfarmaco","started":"2024-03-26","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05171816","kind":"trial","name":"Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (China Cohort)","aka":[],"tldr":"A phase 3 trial of Olaparib, Abiraterone acetate in prostate cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (China Cohort) is a phase 3 interventional study registered as NCT05171816 by AstraZeneca, with 110 participants enrolled, started 2021-06-24 and due to reach its primary completion in 2024-01-22. Interventions recorded: olaparib, abiraterone acetate. Conditions listed: Metastatic Castration-resistant Prostate Cancer. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05171816","url":"https://clinicaltrials.gov/study/NCT05171816"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["olaparib","abiraterone"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05171816","phase":"3","setting":"A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study)","sponsor":"AstraZeneca","started":"2021-06-24","startedType":"actual","yearReported":2025,"enrolled":110,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiological Progression Free Survival (rPFS)","primary":true,"unit":"months","arms":[{"name":"Olaparib 300 mg bd + Abiraterone 1000 mg qd","n":54,"value":14.75,"note":"95% CI 12.06 to 22.11; Figures from the ClinicalTrials.gov results section (first posted 2025-06-29), not from a publication"},{"name":"Placebo bd + Abiraterone 1000 mg qd","n":56,"note":"NA - Not calculated, estimates cannot be calculated due to too few events"}],"hr":1.43,"ci":[0.83,2.48],"p":"0.2592","source":"https://clinicaltrials.gov/study/NCT05171816?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Olaparib 300 mg bd + Abiraterone 1000 mg qd","n":54,"value":27.83,"note":"95% CI 27.83 to NA; Figures from the ClinicalTrials.gov results section (first posted 2025-06-29), not from a publication"},{"name":"Placebo bd + Abiraterone 1000 mg qd","n":56,"note":"NA - Not calculated, estimates cannot be calculated due to too few events"}],"hr":1.14,"ci":[0.57,2.29],"p":"0.7251","source":"https://clinicaltrials.gov/study/NCT05171816?tab=results"}]},{"id":"nct07726446","kind":"trial","name":"Study on Sequential Cryoablation, Relaforp Alpha, and Chemotherapy for Bile Duct Tumors","aka":[],"tldr":"A phase 2 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by Tianjin Medical University Cancer Institute and Hospital, now recruiting.","summary":"Study on Sequential Cryoablation, Relaforp Alpha, and Chemotherapy for Bile Duct Tumors is a phase 2 interventional study registered as NCT07726446 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 30 participants, started 2026-10 and due to reach its primary completion in 2027-10. Interventions recorded: PD-1 and chemotherapy, cryoablation. Conditions listed: Biliary Tract Cancer (BTC). Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07726446","url":"https://clinicaltrials.gov/study/NCT07726446"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07726446","phase":"2","setting":"Safety and Effectiveness of Sequential Cryoablation With Rilafup α and Chemotherapy as First-line Treatment for Intrahepatic Cholangiocarcinoma and Gallbladder Cancer: a Multicenter, Prospective, Single-arm, Phase II Clinical Study","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2026-10","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07104604","kind":"trial","name":"Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Tislelizumab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally","aka":[],"tldr":"A phase 2 trial of irinotecan (and liposomal irinotecan), tislelizumab and capecitabine in colorectal cancer, run by Affiliated Cancer Hospital of Shantou University Medical College, now recruiting.","summary":"Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Tislelizumab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally Advanced Rectal Adenocarcinoma With Low Rectal Involvement is a phase 2, interventional study registered as NCT07104604 by Affiliated Cancer Hospital of Shantou University Medical College, with a registry enrolment figure of 51 participants, started 2025-10-20 and due to reach its primary completion in 2027-03-31. Interventions recorded: Liposomal Irinotecan+Tislelizumab+Capecitabine+Rradiotherapy. Conditions listed: Rectal Cancer. Primary outcome: Complete response (CR) rate. Colorectal eligibility wording from the registry: \"* Biopsy-confirmed pMMR (proficient mismatch repair) localized advanced low rectal adenocarcinoma (tumor's lower edge ≤ 10 cm from the anus)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07104604","url":"https://clinicaltrials.gov/study/NCT07104604"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","topoisomerase-inhibitors"],"targets":[],"drugs":["irinotecan","tislelizumab","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07104604","phase":"2","setting":"Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Tislelizumab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally Advanced Rectal Adenocarcinoma With Low Rectal Involvement","sponsor":"Affiliated Cancer Hospital of Shantou University Medical College","started":"2025-10-20","startedType":"actual","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07471776","kind":"trial","name":"Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer","aka":[],"tldr":"A phase 2 trial of TROP2 PET in Breast cancer, run by Fudan University, now recruiting.","summary":"Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer is a phase 2 interventional study registered as NCT07471776 by Fudan University, with 45 participants planned, started 2026-03-11 and due to reach its primary completion in 2028-03-11. Interventions recorded: Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan, 68Ga-TROP2 PET/CT Imaging, 18F-FDG PET Imaging. Conditions recorded: Metastatic Breast Cancer ( HER2 Negative).\n\nLinked to the technology TROP2 PET because the registry names it (\"trop2 pet\") among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07471776","url":"https://clinicaltrials.gov/study/NCT07471776"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["trop2-pet"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07471776","phase":"2","setting":"Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer","sponsor":"Fudan University","started":"2026-03-11","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03040973","kind":"trial","name":"Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone","aka":[],"tldr":"A phase 2 trial of Capmatinib, Gefitinib and Osimertinib in advanced solid tumours, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone is a phase 2 interventional study registered as NCT03040973 by Novartis Pharmaceuticals, with 29 participants enrolled, started 2017-07-04 and due to reach its primary completion in 2027-07-30. Interventions recorded: Capmatinib, Nazartinib, Gefitinib and Osimertinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03040973","url":"https://clinicaltrials.gov/study/NCT03040973"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["capmatinib","gefitinib","osimertinib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03040973","phase":"2","setting":"An Open-label, Multi-center, Global, Rollover Study for Patients Who Have Previously Been Treated With Capmatinib (INC280) as Monotherapy or in Combination in a Novartis Sponsored Trial.","sponsor":"Novartis Pharmaceuticals","started":"2017-07-04","startedType":"actual","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06107413","kind":"trial","name":"Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unrese","aka":[],"tldr":"A phase 2 trial of Telisotuzumab adizutecan, Bevacizumab, Leucovorin in colorectal cancer, run by AbbVie, active and no longer recruiting.","summary":"Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab is a phase 2 interventional study registered as NCT06107413 by AbbVie, with 280 participants planned, started 2023-11-12 and due to reach its primary completion in 2026-12. Interventions recorded: ABBV-400, Bevacizumab, Folinic Acid, Fluorouracil, Irinotecan. Conditions listed: Unresectable Metastatic Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06107413","url":"https://clinicaltrials.gov/study/NCT06107413"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["telisotuzumab-adizutecan","bevacizumab","leucovorin","fluorouracil","folfiri"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06107413","phase":"2","setting":"A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Folinic Acid, and Bevacizumab and to Evaluate Safety and Efficacy of ABBV-400 in Combination With Bevacizumab in Previously Treated Subjects With Unresectable Metastatic Colorectal Cancer","sponsor":"AbbVie","started":"2023-11-12","startedType":"actual","enrolled":280,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04895436","kind":"trial","name":"Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)","aka":["ReVenG"],"tldr":"A phase 2 trial of Venetoclax and Obinutuzumab in chronic lymphocytic leukaemia, run by AbbVie, now recruiting.","summary":"Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL) is a phase 2 interventional study registered as NCT04895436 by AbbVie, with 75 participants planned, started 2022-03-28 and due to reach its primary completion in 2026-11. Interventions recorded: Venetoclax and Obinutuzumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04895436","url":"https://clinicaltrials.gov/study/NCT04895436"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["venetoclax","obinutuzumab"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04895436","phase":"2","setting":"A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia","sponsor":"AbbVie","started":"2022-03-28","startedType":"actual","enrolled":75,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07387471","kind":"trial","name":"Study to Assess Change in Disease Activity of Oral Venetoclax in Adult Participants With Recurring Relapsed or Refractory (R/R) Waldenström Macroglobu","aka":[],"tldr":"A phase 2 trial of Venetoclax in waldenström macroglobulinaemia, run by AbbVie, active and no longer recruiting.","summary":"Study to Assess Change in Disease Activity of Oral Venetoclax in Adult Participants With Recurring Relapsed or Refractory (R/R) Waldenström Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL) is a phase 2 interventional study registered as NCT07387471 by AbbVie, with 14 participants planned, started 2026-03-17 and due to reach its primary completion in 2028-07. Interventions recorded: Venetoclax. Conditions listed: Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07387471","url":"https://clinicaltrials.gov/study/NCT07387471"}],"tags":["ctgov-ingest"],"related":[],"cancers":["waldenstrom"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["venetoclax"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07387471","phase":"2","setting":"A Phase 2 Study of Venetoclax Monotherapy in Japanese Subjects With Relapsed or Refractory Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma","sponsor":"AbbVie","started":"2026-03-17","startedType":"actual","enrolled":14,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05985655","kind":"trial","name":"Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors","aka":["ELUCIDATE"],"tldr":"A phase 1/2 trial of GTAEXS617 in head and neck squamous cell carcinoma, pancreatic ductal adenocarcinoma, non-small-cell lung cancer, ovarian cancer, HR-positive / HER2-negative breast cancer and triple-negative breast cancer, run by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc., now recruiting.","summary":"Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05985655 by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc., with 230 participants planned, started 2023-07-06 and due to reach its primary completion in 2028-01. Interventions recorded: GTAEXS617 and SoC.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05985655","url":"https://clinicaltrials.gov/study/NCT05985655"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","pancreatic","nsclc","ovarian","breast-hr-positive","tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["recursion"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05985655","phase":"1/2","setting":"A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors","sponsor":"Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.","started":"2023-07-06","startedType":"actual","enrolled":230,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05925530","kind":"trial","name":"Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D,","aka":["MDT-BRIDGE"],"tldr":"A phase 2 trial of Durvalumab in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE) is a phase 2 interventional study registered as NCT05925530 by AstraZeneca, with 142 participants enrolled, started 2024-02-22 and due to reach its primary completion in 2026-01-12. Interventions recorded: Durvalumab. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05925530","url":"https://clinicaltrials.gov/study/NCT05925530"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05925530","phase":"2","setting":"A Multicentre, Phase II, Single-Arm, Interventional Study of Neoadjuvant Durvalumab and Platinum-based Chemotherapy (CT), Followed by Either Surgery and Adjuvant Durvalumab or Chemoradiotherapy (CRT) and Consolidation Durvalumab, in Participants With Resectable or Borderline Resectable Stage IIB-IIIB Non-small Cell Lung Cancer (NSCLC)","sponsor":"AstraZeneca","started":"2024-02-22","startedType":"actual","enrolled":142,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02486718","kind":"trial","name":"Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [","aka":["IMpower010"],"tldr":"A phase 3 trial of Atezolizumab, Cisplatin, Vinorelbine in non-small-cell lung cancer and small-cell lung cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010] is a phase 3 interventional study registered as NCT02486718 by Hoffmann-La Roche, with 1280 participants enrolled, started 2015-10-31 and due to reach its primary completion in 2024-01-26. Interventions recorded: Atezolizumab, Cisplatin, Vinorelbine, Docetaxel, Gemcitabine. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02486718","url":"https://clinicaltrials.gov/study/NCT02486718"},{"label":"IMpower010 (Lancet 2021)","url":"https://doi.org/10.1016/S0140-6736(21)02098-5"},{"label":"NICE TA1071: atezolizumab for adjuvant treatment of resected non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1071"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["atezolizumab","cisplatin","vinorelbine","docetaxel","gemcitabine","pemetrexed"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":["keynote-091","adaura","alina"],"people":[],"bottlenecks":[],"keyPapers":["paper-felip-impower010-adjuvant-atezolizumab-lancet-2021","paper-nct02486718-ann-oncol-2023-update"],"journals":[],"dependsOn":[],"notes":["IMpower010 enrolled 1,280 patients at 227 sites in 22 countries between October 2015 and September 2018; 1,269 received adjuvant platinum-based chemotherapy and 1,005 were randomised to atezolizumab 1200 mg every 21 days for 16 cycles or one year (507) or to best supportive care (498). Disease-free survival was tested hierarchically: first in the stage II to IIIA subgroup whose tumours expressed PD-L1 on 1 percent or more of tumour cells by the SP263 assay, then in all stage II to IIIA patients, then in the stage IB to IIIA intention-to-treat population (Lancet 2021)."],"nct":"NCT02486718","phase":"3","setting":"A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer","sponsor":"Hoffmann-La Roche","result":"IMpower010: adjuvant atezolizumab after platinum chemotherapy improved disease-free survival in resected stage II to IIIA non-small-cell lung cancer, most in tumours with PD-L1 on 1 percent or more of tumour cells (hazard ratio 0.66); approved in the United States in October 2021 for that group.","started":"2015-10-31","startedType":"actual","yearReported":2021,"enrolled":1280,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival, stage II to IIIA with PD-L1 on 1% or more of tumour cells","primary":true,"unit":"months","arms":[{"name":"Atezolizumab after adjuvant chemotherapy","value":68.5,"note":"Registry results, up to 95 months; 95% CI 51.8 to not reached"},{"name":"Best supportive care","value":37.3,"note":"95% CI 30.1 to 57.8"}],"hr":0.704,"ci":[0.545,0.91],"source":"https://clinicaltrials.gov/study/NCT02486718?tab=results"},{"endpoint":"Disease-free survival, all randomised stage II to IIIA","primary":true,"unit":"months","arms":[{"name":"Atezolizumab after adjuvant chemotherapy","value":57.4,"note":"95% CI 42.2 to not reached"},{"name":"Best supportive care","value":40.8,"note":"95% CI 31.4 to 57.1"}],"hr":0.83,"ci":[0.691,0.998],"source":"https://clinicaltrials.gov/study/NCT02486718?tab=results"},{"endpoint":"Disease-free survival, intention-to-treat population (stage IB to IIIA)","primary":true,"unit":"months","arms":[{"name":"Atezolizumab after adjuvant chemotherapy","n":507,"value":65.6,"note":"95% CI 52.4 to not reached"},{"name":"Best supportive care","n":498,"value":47.8,"note":"95% CI 37.0 to 65.8"}],"hr":0.848,"ci":[0.71,1.013],"p":"0.0683","source":"https://clinicaltrials.gov/study/NCT02486718?tab=results"},{"endpoint":"Disease-free survival at the primary analysis (Lancet 2021), stage II to IIIA with PD-L1 on 1% or more of tumour cells","arms":[{"name":"Atezolizumab after adjuvant chemotherapy","note":"Median follow-up 32.2 months"},{"name":"Best supportive care"}],"hr":0.66,"ci":[0.5,0.88],"p":"0.0039","source":"https://doi.org/10.1016/S0140-6736(21)02098-5"},{"endpoint":"Atezolizumab-related grade 3 to 4 adverse events","unit":"%","arms":[{"name":"Atezolizumab after adjuvant chemotherapy","n":495,"value":11,"note":"53 patients; grade 5 events in 4 (1%)"}],"source":"https://doi.org/10.1016/S0140-6736(21)02098-5"}],"replication":"KEYNOTE-091 found an adjuvant disease-free survival benefit for pembrolizumab in the whole population but not in the PD-L1-high subgroup, the opposite pattern."},{"id":"nct05588648","kind":"trial","name":"Study to Assess Safety and Efficacy of Vactosertib in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma","aka":[],"tldr":"A phase 1/2 trial of Vactosertib in osteosarcoma, run by MedPacto, Inc., now recruiting.","summary":"Study to Assess Safety and Efficacy of Vactosertib in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma is a phase 1/2 interventional study registered as NCT05588648 by MedPacto, Inc., with 48 participants planned, started 2023-05-01 and due to reach its primary completion in 2025-09. Interventions recorded: Vactosertib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05588648","url":"https://clinicaltrials.gov/study/NCT05588648"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["osteosarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["vactosertib"],"companies":["medpacto"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05588648","phase":"1/2","setting":"A Phase I/II, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Vactosertib as a Single Agent in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma","sponsor":"MedPacto, Inc.","started":"2023-05-01","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04879043","kind":"trial","name":"Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma","aka":[],"tldr":"A phase 1/2 trial of HDP-101 in multiple myeloma, run by Heidelberg Pharma AG, now recruiting.","summary":"Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT04879043 by Heidelberg Pharma AG, with 78 participants planned, started 2022-02-07 and due to reach its primary completion in 2028-03. Interventions recorded: HDP-101.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04879043","url":"https://clinicaltrials.gov/study/NCT04879043"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["heidelberg-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04879043","phase":"1/2","setting":"A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients With Plasma Cell Disorders Including Multiple Myeloma","sponsor":"Heidelberg Pharma AG","started":"2022-02-07","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05499013","kind":"trial","name":"Study to Assess SLN124 in Patients With Polycythemia Vera","aka":[],"tldr":"A phase 1/2 trial of SLN124 in myeloproliferative neoplasms, run by Silence Therapeutics plc, active and no longer recruiting.","summary":"Study to Assess SLN124 in Patients With Polycythemia Vera is a phase 1/2 interventional study registered as NCT05499013 by Silence Therapeutics plc, with 69 participants enrolled, started 2023-01-26 and due to reach its primary completion in 2026-09. Interventions recorded: SLN124 and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05499013","url":"https://clinicaltrials.gov/study/NCT05499013"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05499013","phase":"1/2","setting":"Phase 1/2 Study With an Open-label Dose Escalation Phase Followed by a Randomized, Double-blind Phase of SLN124 in Patients With Polycythemia Vera","sponsor":"Silence Therapeutics plc","started":"2023-01-26","startedType":"actual","enrolled":69,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05546866","kind":"trial","name":"Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm","aka":[],"tldr":"A phase 2 trial of Osimertinib in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm is a phase 2 interventional study registered as NCT05546866 by AstraZeneca, with 51 participants enrolled, started 2023-02-09 and due to reach its primary completion in 2029-06-30. Interventions recorded: Osimertinib. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05546866","url":"https://clinicaltrials.gov/study/NCT05546866"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05546866","phase":"2","setting":"An Open-label, Prospective, Multi-center, Single-arm Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in Non-small Cell Lung Cancer (NSCLC) With Uncommon Epidermal Growth Factor Receptor Mutations (EGFRm)","sponsor":"AstraZeneca","started":"2023-02-09","startedType":"actual","enrolled":51,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05038735","kind":"trial","name":"Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.","aka":["EPIK-B5"],"tldr":"A phase 3 trial of Alpelisib and Fulvestrant in HR-positive / HER2-negative breast cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. is a phase 3 interventional study registered as NCT05038735 by Novartis Pharmaceuticals, with 210 participants enrolled, started 2021-12-17 and due to reach its primary completion in 2027-01-28. Interventions recorded: Alpelisib, Fulvestrant and Alpelisib-matching placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05038735","url":"https://clinicaltrials.gov/study/NCT05038735"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["endocrine-therapy","kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["alpelisib","fulvestrant"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05038735","phase":"3","setting":"EPIK-B5: A Phase III, Randomized, Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With HR-positive, HER2-negative Advanced Breast Cancer With a PIK3CA Mutation, Who Progressed on or After Aromatase Inhibitor and a CDK4/6 Inhibitor","sponsor":"Novartis Pharmaceuticals","started":"2021-12-17","startedType":"actual","enrolled":210,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07166094","kind":"trial","name":"Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer","aka":["RAINFOL-03"],"tldr":"A phase 3 trial of Rinatabart sesutecan in endometrial cancer, run by Genmab, now recruiting.","summary":"Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer is a phase 3 interventional study registered as NCT07166094 by Genmab, with 660 participants planned, started 2025-11-28 and due to reach its primary completion in 2029-08. Interventions recorded: Rina-S, IC. Conditions listed: Endometrial Cancer, Recurrent or Progressive Endometrial Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07166094","url":"https://clinicaltrials.gov/study/NCT07166094"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["rinatabart-sesutecan"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07166094","phase":"3","setting":"A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy","sponsor":"Genmab","started":"2025-11-28","startedType":"actual","enrolled":660,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07288177","kind":"trial","name":"Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer","aka":["RAINFOL-05"],"tldr":"A phase 2 trial of Rinatabart sesutecan in non-small-cell lung cancer and small-cell lung cancer, run by Genmab, now recruiting.","summary":"Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT07288177 by Genmab, with 240 participants planned, started 2026-01-30 and due to reach its primary completion in 2027-11-22. Interventions recorded: Rina-S. Conditions listed: Non-small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07288177","url":"https://clinicaltrials.gov/study/NCT07288177"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["rinatabart-sesutecan"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07288177","phase":"2","setting":"A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer","sponsor":"Genmab","started":"2026-01-30","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07225270","kind":"trial","name":"Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Re","aka":["RAINFOL-04"],"tldr":"A phase 3 trial of Rinatabart sesutecan, Bevacizumab in ovarian cancer, run by Genmab, now recruiting.","summary":"Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy is a phase 3 interventional study registered as NCT07225270 by Genmab, with 544 participants planned, started 2026-04-03 and due to reach its primary completion in 2028-10. Interventions recorded: Rina-S, Bevacizumab. Conditions listed: Ovarian Cancer, Platinum-sensitive Ovarian Cancer, PSOC. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07225270","url":"https://clinicaltrials.gov/study/NCT07225270"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["rinatabart-sesutecan","bevacizumab"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07225270","phase":"3","setting":"A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L Platinum-Based Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)","sponsor":"Genmab","started":"2026-04-03","startedType":"actual","enrolled":544,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07564141","kind":"trial","name":"Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or","aka":["RAINFOL-07"],"tldr":"A phase 3 trial of Rinatabart sesutecan, Bevacizumab, Carboplatin in ovarian cancer, run by Genmab, now recruiting.","summary":"Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer is a phase 3 interventional study registered as NCT07564141 by Genmab, with 688 participants planned, started 2026-08-28 and due to reach its primary completion in 2029-12. Interventions recorded: Rina-S, Bevacizumab, Carboplatin, Gemcitabine, Paclitaxel. Conditions listed: Platinum-Sensitive Ovarian Cancer, Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07564141","url":"https://clinicaltrials.gov/study/NCT07564141"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["rinatabart-sesutecan","bevacizumab","carboplatin","gemcitabine","paclitaxel"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07564141","phase":"3","setting":"A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer","sponsor":"Genmab","started":"2026-08-28","startedType":"actual","enrolled":688,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02793583","kind":"trial","name":"Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma","aka":[],"tldr":"A phase 2/3 trial of Umbralisib and Bendamustine in Diffuse large B-cell lymphoma, Follicular lymphoma, Marginal zone lymphoma and Mantle cell lymphoma, run by TG Therapeutics, Inc., recorded as terminated on the registry.","summary":"Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma is a phase 2/3 interventional study registered as NCT02793583 by TG Therapeutics, Inc., with 710 participants recorded, started 2016-05-25 and due to reach its primary completion in 2022-05-31. Interventions recorded: Ublituximab, Umbralisib, Bendamustine. Conditions recorded: Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Small Lymphocytic Lymphoma.\n\nLinked to the drug Umbralisib because the registry names it among its interventions and Diffuse large B-cell lymphoma, Follicular lymphoma, Marginal zone lymphoma and Mantle cell lymphoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02793583","url":"https://clinicaltrials.gov/study/NCT02793583"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["dlbcl","follicular-lymphoma","marginal-zone-lymphoma","mantle-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["umbralisib","bendamustine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02793583","phase":"2/3","setting":"A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma","sponsor":"TG Therapeutics, Inc.","started":"2016-05-25","startedType":"actual","enrolled":710,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03801525","kind":"trial","name":"Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)","aka":["ULTRA-V"],"tldr":"A phase 2/3 trial of Umbralisib and Venetoclax in Chronic lymphocytic leukaemia, run by TG Therapeutics, Inc., recorded as terminated on the registry.","summary":"Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V) is a phase 2/3 interventional study registered as NCT03801525 by TG Therapeutics, Inc., with 277 participants recorded, started 2019-05-16 and due to reach its primary completion in 2022-12-20. Interventions recorded: Ublituximab, Umbralisib, Venetoclax. Conditions recorded: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.\n\nLinked to the drug Umbralisib because the registry names it among its interventions and Chronic lymphocytic leukaemia among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03801525","url":"https://clinicaltrials.gov/study/NCT03801525"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll"],"sections":[],"technologies":[],"targets":[],"drugs":["umbralisib","venetoclax"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03801525","phase":"2/3","setting":"Phase 2/3 Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects With Chronic Lymphocytic Leukemia (CLL)","sponsor":"TG Therapeutics, Inc.","started":"2019-05-16","startedType":"actual","yearReported":2024,"enrolled":277,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase 2: Complete Response (CR) Rate as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Criteria","primary":true,"unit":"%","arms":[{"name":"Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V)","n":149,"value":33.6,"note":"Figures from the ClinicalTrials.gov results section (first posted 2024-04-19), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03801525?tab=results"},{"endpoint":"Phase 2: Overall Response Rate (ORR) Per iwCLL 2018 Criteria","primary":true,"unit":"%","arms":[{"name":"Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V)","n":149,"value":93.3,"note":"Figures from the ClinicalTrials.gov results section (first posted 2024-04-19), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03801525?tab=results"}]},{"id":"nct06619236","kind":"trial","name":"Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer","aka":["RAINFOL-02"],"tldr":"A phase 3 trial of Rinatabart sesutecan, Paclitaxel / nab-paclitaxel, Topotecan in ovarian cancer, run by Genmab, active and no longer recruiting.","summary":"Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer is a phase 3 interventional study registered as NCT06619236 by Genmab, with 530 participants planned, started 2025-02-07 and due to reach its primary completion in 2027-02. Interventions recorded: Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin (PLD), Gemcitabine. Conditions listed: Platinum-resistant Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06619236","url":"https://clinicaltrials.gov/study/NCT06619236"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["rinatabart-sesutecan","paclitaxel","topotecan","pegylated-liposomal-doxorubicin","gemcitabine"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06619236","phase":"3","setting":"A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer","sponsor":"Genmab","started":"2025-02-07","startedType":"actual","enrolled":530,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05257993","kind":"trial","name":"Study to Assess the Safety, Tolerability of JPI-547 in Combination With Modified FOLFIRINOX or Gemcitabine-nab-paclitaxel in Patients With Locally Adv","aka":[],"tldr":"A phase 1/2 trial of Gemcitabine + nab-paclitaxel in pancreatic ductal adenocarcinoma, run by Onconic Therapeutics Inc., now recruiting.","summary":"Study to Assess the Safety, Tolerability of JPI-547 in Combination With Modified FOLFIRINOX or Gemcitabine-nab-paclitaxel in Patients With Locally Advanced and Metastatic Pancreatic Cancer is a phase 1/2 interventional study registered as NCT05257993 by Onconic Therapeutics Inc., with 71 participants planned, started 2022-03-30 and due to reach its primary completion in 2030-04. Interventions recorded: JPI-547, modified FOLFIRINOX, Gemcitabine-nab-paclitaxel. Conditions listed: Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05257993","url":"https://clinicaltrials.gov/study/NCT05257993"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05257993","phase":"1/2","setting":"An Open-label, Dose-finding, Phase Ib/II Study to Assess the Safety, Tolerability of JPI-547, a Dual Inhibitor of PARP/Tankyrase, in Combination With Modified FOLFIRINOX (mFOLFIRINOX) or Gemcitabine-nab-paclitaxel (GemAbraxne) in Patients With Locally Advanced and Metastatic Pancreatic Cancer","sponsor":"Onconic Therapeutics Inc.","started":"2022-03-30","startedType":"actual","enrolled":71,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04725994","kind":"trial","name":"Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX or Irinotecan in Patients With Advanced Gastric Cancer","aka":[],"tldr":"A phase 1/2 trial of IDX-1197+XELOX in gastric & gastro-oesophageal junction cancer, run by Idience Co., Ltd., active and no longer recruiting.","summary":"Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX or Irinotecan in Patients With Advanced Gastric Cancer is a phase 1/2 interventional study registered as NCT04725994 by Idience Co., Ltd., with 87 participants enrolled, started 2021-06-28 and due to reach its primary completion in 2026-07-31. Interventions recorded: IDX-1197+XELOX and IDX-1197+Irinotecan.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04725994","url":"https://clinicaltrials.gov/study/NCT04725994"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["capox","oxaliplatin","irinotecan","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04725994","phase":"1/2","setting":"An Open-Label, International, Multicenter, Phase 1b/2a Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX (Capecitabine and Oxaliplatin) or Irinotecan in Patients With Advanced Gastric Cancer","sponsor":"Idience Co., Ltd.","started":"2021-06-28","startedType":"actual","enrolled":87,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04410445","kind":"trial","name":"Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence","aka":["PIVOT-12"],"tldr":"A phase 3 trial of Bempegaldesleukin and Nivolumab in Melanoma, run by Nektar Therapeutics, recorded as terminated on the registry.","summary":"Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence is a phase 3 interventional study registered as NCT04410445 by Nektar Therapeutics, with 765 participants recorded, started 2020-07-27 and due to reach its primary completion in 2022-09-22. Interventions recorded: Bempegaldesleukin, Nivolumab. Conditions recorded: Melanoma, Melanoma Stage III, Melanoma Stage IV, Melanoma (Skin).\n\nLinked to the drug Bempegaldesleukin because the registry names it among its interventions and Melanoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04410445","url":"https://clinicaltrials.gov/study/NCT04410445"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["bempegaldesleukin","nivolumab"],"companies":["nektar-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04410445","phase":"3","setting":"A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)","sponsor":"Nektar Therapeutics","started":"2020-07-27","startedType":"actual","enrolled":765,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04090736","kind":"trial","name":"Study to Compare Azacitidine Plus Pevonedistat Versus Azacitidine in Patients With Acute Myeloid Leukemia Not Eligible for Standard Chemotherapy","aka":["PEVOLAM"],"tldr":"A phase 3 trial of Pevonedistat and Azacitidine in Leukaemia, run by PETHEMA Foundation, active and no longer recruiting.","summary":"Study to Compare Azacitidine Plus Pevonedistat Versus Azacitidine in Patients With Acute Myeloid Leukemia Not Eligible for Standard Chemotherapy is a phase 3 interventional study registered as NCT04090736 by PETHEMA Foundation, with 302 participants planned, started 2019-09-24 and due to reach its primary completion in 2023-06-30. Interventions recorded: Pevonedistat, Azacitidine. Conditions recorded: Leukemia, Myeloid, Acute.\n\nLinked to the drug Pevonedistat because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04090736","url":"https://clinicaltrials.gov/study/NCT04090736"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["pevonedistat","azacitidine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04090736","phase":"3","setting":"A Randomized Phase III, Multicentre, Open Label Clinical Trial Comparing Azacitidine Plus Pevonedistat Versus Azacitidine in Older/Unfit Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Chemotherapy","sponsor":"PETHEMA Foundation","started":"2019-09-24","startedType":"actual","enrolled":302,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05607550","kind":"trial","name":"Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With","aka":["FURVENT"],"tldr":"A phase 3 trial of Furmonertinib in non-small-cell lung cancer and small-cell lung cancer, run by ArriVent BioPharma, Inc., active and no longer recruiting.","summary":"Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT) is a phase 3 interventional study registered as NCT05607550 by ArriVent BioPharma, Inc., with 398 participants enrolled, started 2023-06-01 and due to reach its primary completion in 2025-08-15. Interventions recorded: furmonertinib 240 mg oral, daily, furmonertinib 160 mg oral, daily, platinum-based chemotherapy. Conditions listed: Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, EGFR Exon 20 Mutations. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05607550","url":"https://clinicaltrials.gov/study/NCT05607550"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["furmonertinib"],"companies":["arrivent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05607550","phase":"3","setting":"A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Furmonertinib Compared to Platinum-Based Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)","sponsor":"ArriVent BioPharma, Inc.","started":"2023-06-01","startedType":"actual","enrolled":398,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07221734","kind":"trial","name":"Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma","aka":["LEON"],"tldr":"A phase 3 trial of Nivolumab in melanoma, run by mAbxience Research S.L., now recruiting.","summary":"Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma is a phase 3 interventional study registered as NCT07221734 by mAbxience Research S.L., with 632 participants planned, started 2025-12-29 and due to reach its primary completion in 2027-04. Interventions recorded: MB11 (Proposed Nivolumab Biosimilar), EU-Opdivo® and US- sourced Opdivo®.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07221734","url":"https://clinicaltrials.gov/study/NCT07221734"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["mabxience-research-s-l"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07221734","phase":"3","setting":"Randomised, Multicentre, Multinational, Double-Blind Integrated Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 (Proposed Nivolumab Biosimilar) Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced (Unresectable or Metastatic) Melanoma (LEON Study)","sponsor":"mAbxience Research S.L.","started":"2025-12-29","startedType":"actual","enrolled":632,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04174599","kind":"trial","name":"Study to Compare the Efficacy and Safety of F-627 and GRAN®","aka":[],"tldr":"A phase 3 trial of Efbemalenograstim alfa and Filgrastim in Breast cancer, run by EVIVE Biotechnology, completed.","summary":"Study to Compare the Efficacy and Safety of F-627 and GRAN® is a phase 3 interventional study registered as NCT04174599 by EVIVE Biotechnology, with 242 participants recorded, started 2018-04-12 and reaching its primary completion in 2019-01-24. Interventions recorded: F-627, GRAN®. Conditions recorded: Breast Cancer, Neutropenia.\n\nLinked to the drug Efbemalenograstim alfa because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04174599","url":"https://clinicaltrials.gov/study/NCT04174599"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["efbemalenograstim-alfa","filgrastim"],"companies":["evive-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04174599","phase":"3","setting":"A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of F-627 and GRAN® in the Prophylactic Treatment for Chemotherapy-Induced Neutropenia","sponsor":"EVIVE Biotechnology","started":"2018-04-12","startedType":"actual","yearReported":2025,"enrolled":242,"enrolledBasis":"registry","outcomes":[{"endpoint":"Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1","primary":true,"unit":"days","arms":[{"name":"F-627","n":120,"value":0.68,"note":"SD 1.100; Figures from the ClinicalTrials.gov results section (first posted 2025-04-20), not from a publication"},{"name":"GRAN®","n":119,"value":0.71,"note":"SD 0.967"}],"source":"https://clinicaltrials.gov/study/NCT04174599?tab=results"}]},{"id":"nct01081951","kind":"trial","name":"Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitax","aka":[],"tldr":"A phase 2 trial of Olaparib, Paclitaxel / nab-paclitaxel, Carboplatin in ovarian cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer is a phase 2 interventional study registered as NCT01081951 by AstraZeneca, with 162 participants enrolled, started 2010-02-04 and due to reach its primary completion in 2011-10-10. Interventions recorded: olaparib, paclitaxel, carboplatin, paclitaxel, Drug: carboplatin. Conditions listed: Ovarian Cancer. Results were posted on ClinicalTrials.gov in 2012; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01081951","url":"https://clinicaltrials.gov/study/NCT01081951"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","parp-inhibitor","platinum"],"targets":[],"drugs":["olaparib","paclitaxel","carboplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01081951","phase":"2","setting":"A Phase II Open Label Randomised Comparative Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Patients With Platinum Sensitive Advanced Serous Ovarian Cancer","sponsor":"AstraZeneca","started":"2010-02-04","startedType":"actual","yearReported":2012,"enrolled":162,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Olaparib/Carboplatin AUC4/Paclitaxel","n":81,"value":12.2,"note":"95% CI 9.7 to 15.0; Figures from the ClinicalTrials.gov results section (first posted 2012-12-10), not from a publication"},{"name":"Carboplatin AUC6/Paclitaxel","n":81,"value":9.6,"note":"95% CI 9.1 to 9.7"}],"hr":0.51,"ci":[0.34,0.77],"p":"0.0012","source":"https://clinicaltrials.gov/study/NCT01081951?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"participants (number of deaths)","arms":[{"name":"Olaparib/Carboplatin AUC4/Paclitaxel","n":81,"value":54,"note":"Figures from the ClinicalTrials.gov results section (first posted 2012-12-10), not from a publication"},{"name":"Carboplatin AUC6/Paclitaxel","n":81,"value":47}],"hr":1.17,"ci":[0.79,1.73],"p":"0.4379","source":"https://clinicaltrials.gov/study/NCT01081951?tab=results"}]},{"id":"nct04464226","kind":"trial","name":"Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer","aka":[],"tldr":"A phase 3 trial of Darolutamide in advanced solid tumours, run by Bayer, active and no longer recruiting.","summary":"Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer is a phase 3 interventional study registered as NCT04464226 by Bayer, with 402 participants enrolled, started 2020-10-20 and due to reach its primary completion in 2028-06-26. Interventions recorded: Darolutamide (Nubeqa, BAY1841788).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04464226","url":"https://clinicaltrials.gov/study/NCT04464226"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["darolutamide"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04464226","phase":"3","setting":"An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies","sponsor":"Bayer","started":"2020-10-20","startedType":"actual","enrolled":402,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04925479","kind":"trial","name":"Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia","aka":[],"tldr":"A phase 1/2 trial of Asciminib in chronic myeloid leukaemia, run by Novartis Pharmaceuticals, now recruiting.","summary":"Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia is a phase 1/2 interventional study registered as NCT04925479 by Novartis Pharmaceuticals, with 34 participants planned, started 2021-12-27 and due to reach its primary completion in 2027-09-21. Interventions recorded: Asciminib Pediatric formulation group and Asciminib Adult formulation group.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04925479","url":"https://clinicaltrials.gov/study/NCT04925479"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cml","cml-chronic-phase"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["asciminib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04925479","phase":"1/2","setting":"A Multi-center, Open-label Study to Determine the Dose and Safety of Oral Asciminib in Pediatric Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP), Previously Treated With One or More Tyrosine Kinase Inhibitors","sponsor":"Novartis Pharmaceuticals","started":"2021-12-27","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07354074","kind":"trial","name":"Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP","aka":[],"tldr":"A phase 2 trial of Asciminib in chronic myeloid leukaemia, run by Novartis Pharmaceuticals, now recruiting.","summary":"Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP is a phase 2 interventional study registered as NCT07354074 by Novartis Pharmaceuticals, with 50 participants planned, started 2026-04-28 and due to reach its primary completion in 2033-02-23. Interventions recorded: Asciminib single agent.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07354074","url":"https://clinicaltrials.gov/study/NCT07354074"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cml","cml-chronic-phase"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["asciminib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07354074","phase":"2","setting":"A Phase II, Multicenter, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Asciminib in Pediatric Participants Newly Diagnosed or Previously Treated With Philadelphia Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) With or Without Known T315I Mutation","sponsor":"Novartis Pharmaceuticals","started":"2026-04-28","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04410133","kind":"trial","name":"Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases","aka":[],"tldr":"A phase 3 trial of Fluciclovine F-18 in Brain metastases, run by Blue Earth Diagnostics, completed.","summary":"Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases is a phase 3 interventional study registered as NCT04410133 by Blue Earth Diagnostics, with 151 participants recorded, started 2020-10-26 and reaching its primary completion in 2023-06-05. Interventions recorded: 18F fluciclovine. Conditions recorded: Brain Metastases.\n\nLinked to the drug Fluciclovine F-18 because the registry names it among its interventions and Brain metastases among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04410133","url":"https://clinicaltrials.gov/study/NCT04410133"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["secondary-brain-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["fluciclovine-f18"],"companies":["blue-earth-diagnostics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04410133","phase":"3","setting":"An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 3 Study to Establish the Diagnostic Performance of 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy","sponsor":"Blue Earth Diagnostics","started":"2020-10-26","startedType":"actual","yearReported":2025,"enrolled":151,"enrolledBasis":"registry","outcomes":[{"endpoint":"Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level","primary":true,"unit":"%","arms":[{"name":"Reader 1 - Positive Percent Agreement (PPA)","n":42,"value":23.8,"note":"95% CI 12.1 to 39.5; Figures from the ClinicalTrials.gov results section (first posted 2025-08-28), not from a publication"},{"name":"Reader 2 - Positive Percent Agreement (PPA)","n":41,"value":34.1,"note":"95% CI 20.1 to 50.6"},{"name":"Reader 3 - Positive Percent Agreement (PPA)","n":41,"value":36.6,"note":"95% CI 22.1 to 53.1"},{"name":"Reader 1 - Negative Percent Agreement (NPA)","n":109,"value":82.6,"note":"95% CI 74.1 to 89.2"},{"name":"Reader 2 - Negative Percent Agreement (NPA)","n":110,"value":70.9,"note":"95% CI 61.5 to 79.2"},{"name":"Reader 3 - Negative Percent Agreement (NPA)","n":110,"value":70.9,"note":"95% CI 61.5 to 79.2"}],"source":"https://clinicaltrials.gov/study/NCT04410133?tab=results"}]},{"id":"nct06632951","kind":"trial","name":"Study to Evaluate Adverse Events and Change in Disease Activity When Intravenously (IV) Infused Livmoniplimab is Used in Combination With IV Infused Budigalimab in Adult Participants With Urothelial Carcinoma (UC)","aka":["LIVIGNO-3"],"tldr":"A phase 2 trial of Livmoniplimab, Budigalimab, Docetaxel and Gemcitabine in bladder & urothelial cancer, run by AbbVie, active and no longer recruiting.","summary":"Study to Evaluate Adverse Events and Change in Disease Activity When Intravenously (IV) Infused Livmoniplimab is Used in Combination With IV Infused Budigalimab in Adult Participants With Urothelial Carcinoma (UC) is a phase 2 interventional study registered as NCT06632951 by AbbVie, with 150 participants enrolled, started 2025-01-20 and due to reach its primary completion in 2027-03. Interventions recorded: Livmoniplimab, Budigalimab, Docetaxel, Paclitaxel and Gemcitabine.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06632951","url":"https://clinicaltrials.gov/study/NCT06632951"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["livmoniplimab","budigalimab","docetaxel","gemcitabine"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06632951","phase":"2","setting":"A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma","sponsor":"AbbVie","started":"2025-01-20","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06772623","kind":"trial","name":"Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations","aka":[],"tldr":"A phase 1/2 trial of Telisotuzumab adizutecan, Budigalimab, Pembrolizumab, Carboplatin, Pemetrexed and Cisplatin in non-small-cell lung cancer, run by AbbVie, now recruiting.","summary":"Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations is a phase 1/2 interventional study registered as NCT06772623 by AbbVie, with 252 participants planned, started 2025-03-06 and due to reach its primary completion in 2027-11. Interventions recorded: Telisotuzumab Adizutecan, Budigalimab, Pembrolizumab, Carboplatin, Pemetrexed and Cisplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06772623","url":"https://clinicaltrials.gov/study/NCT06772623"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["telisotuzumab-adizutecan","budigalimab","pembrolizumab","carboplatin","pemetrexed","cisplatin"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06772623","phase":"1/2","setting":"An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations","sponsor":"AbbVie","started":"2025-03-06","startedType":"actual","enrolled":252,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05822752","kind":"trial","name":"Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Bu","aka":["LIVIGNO-1"],"tldr":"A phase 2 trial of Budigalimab, Livmoniplimab, Lenvatinib in hepatocellular carcinoma, run by AbbVie, active and no longer recruiting.","summary":"Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC) is a phase 2 interventional study registered as NCT05822752 by AbbVie, with 130 participants enrolled, started 2023-09-21 and due to reach its primary completion in 2026-11. Interventions recorded: Budigalimab, Livmoniplimab, Lenvatinib, Sorafenib. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05822752","url":"https://clinicaltrials.gov/study/NCT05822752"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":["budigalimab","livmoniplimab","lenvatinib","sorafenib"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05822752","phase":"2","setting":"A Phase 2, Randomized Study to Evaluate the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab for Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Patients Who Have Progressed After an Immune Checkpoint Inhibitor Containing Regimen in First-Line HCC","sponsor":"AbbVie","started":"2023-09-21","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nsclc-2","kind":"trial","name":"Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)","aka":["LIVIGNO-4"],"tldr":"A phase 2/3 trial testing Budigalimab in non-small-cell lung cancer, now recruiting.","summary":"Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) is a phase 2/3 interventional study registered as NCT06236438, led by AbbVie, and recruiting on the registry. Official title: A Randomised, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC). Planned enrolment is 840 participants (estimated). The study started in 2024-04-10 and primary completion is expected in 2031-10. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06236438","url":"https://clinicaltrials.gov/study/NCT06236438"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["budigalimab","livmoniplimab"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06236438","phase":"2/3","setting":"A Randomized, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)","sponsor":"AbbVie","started":"2024-04-10","startedType":"actual","enrolled":840,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04068597","kind":"trial","name":"Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies","aka":[],"tldr":"A phase 1/2 trial of Pomalidomide, Dexamethasone, Azacitidine in hodgkin lymphoma and non-hodgkin lymphoma, run by CellCentric Ltd., now recruiting.","summary":"Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies is a phase 1/2 interventional study registered as NCT04068597 by CellCentric Ltd., with 250 participants planned, started 2019-08-09 and due to reach its primary completion in 2027-03-31. Interventions recorded: CCS1477, Pomalidomide, Dexamethasone, Azacitidine, Venetoclax. Conditions listed: Haematological Malignancy, Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04068597","url":"https://clinicaltrials.gov/study/NCT04068597"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma","multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["pomalidomide","dexamethasone","azacitidine","venetoclax","bortezomib","ixazomib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04068597","phase":"1/2","setting":"An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination in Patients With Advanced Haematological Malignancies.","sponsor":"CellCentric Ltd.","started":"2019-08-09","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05379946","kind":"trial","name":"Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Garsorasib and IN10018 in advanced solid tumours, run by InventisBio Co., Ltd, active and no longer recruiting.","summary":"Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors is a phase 1/2 interventional study registered as NCT05379946 by InventisBio Co., Ltd, with 92 participants enrolled, started 2022-10-12 and due to reach its primary completion in 2027-12-31. Interventions recorded: D-1553 and IN10018.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05379946","url":"https://clinicaltrials.gov/study/NCT05379946"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors","kras-inhibitors"],"targets":[],"drugs":["garsorasib","in10018"],"companies":["inventisbio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05379946","phase":"1/2","setting":"A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Combination With IN10018 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation","sponsor":"InventisBio Co., Ltd","started":"2022-10-12","startedType":"actual","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04585035","kind":"trial","name":"Study to Evaluate D-1553 in Subjects With Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Garsorasib, Cetuximab and Pembrolizumab in non-small-cell lung cancer, run by InventisBio Co., Ltd, active and no longer recruiting.","summary":"Study to Evaluate D-1553 in Subjects With Solid Tumors is a phase 1/2 interventional study registered as NCT04585035 by InventisBio Co., Ltd, with 180 participants enrolled, started 2020-10-02 and due to reach its primary completion in 2024-04-30. Interventions recorded: D-1553 and D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04585035","url":"https://clinicaltrials.gov/study/NCT04585035"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":["kinase-inhibitors","kras-inhibitors"],"targets":[],"drugs":["garsorasib","cetuximab","pembrolizumab"],"companies":["inventisbio","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04585035-signal-transduct-target-ther-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04585035","phase":"1/2","setting":"A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation","sponsor":"InventisBio Co., Ltd","started":"2020-10-02","startedType":"actual","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04851613","kind":"trial","name":"Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer","aka":[],"tldr":"A phase 3 trial of Afuresertib in advanced solid tumours, run by Laekna Limited, active and no longer recruiting.","summary":"Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer is a phase 3 interventional study registered as NCT04851613 by Laekna Limited, with 256 participants enrolled, started 2022-02-18 and due to reach its primary completion in 2026-10-30. Interventions recorded: Afuresertib and Afuresertib/placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04851613","url":"https://clinicaltrials.gov/study/NCT04851613"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["fulvestrant"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04851613","phase":"3","setting":"A Phase Ib/III Study to Evaluate the Efficacy and Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Failed Standard of Care Therapies","sponsor":"Laekna Limited","started":"2022-02-18","startedType":"actual","enrolled":256,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07185997","kind":"trial","name":"Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants W","aka":["ALPACCA"],"tldr":"A phase 3 trial of Furmonertinib in non-small-cell lung cancer and small-cell lung cancer, run by ArriVent BioPharma, Inc., now recruiting.","summary":"Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations is a phase 3 interventional study registered as NCT07185997 by ArriVent BioPharma, Inc., with 480 participants planned, started 2025-12-17 and due to reach its primary completion in 2029-02. Interventions recorded: Firmonertinib, EGFR-TKI inhibitor based on investigator's choice. Conditions listed: Non-Small-Cell Lung Cancer, Metastatic Non-Small-Cell Lung Cancer, Advanced Non-Small-Cell Lung Cancer, EGFR P-Loop and Alpha C-Helix Compressing. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07185997","url":"https://clinicaltrials.gov/study/NCT07185997"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["furmonertinib"],"companies":["arrivent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07185997","phase":"3","setting":"A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)","sponsor":"ArriVent BioPharma, Inc.","started":"2025-12-17","startedType":"actual","enrolled":480,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06909877","kind":"trial","name":"Study to Evaluate Efficacy and Safety of HH2853 in Relapsed/Refractory Peripheral T-cell Lymphoma","aka":[],"tldr":"A phase 1/2 trial of HH2853 Tablets in peripheral T-cell lymphomas, run by Haihe Biopharma Co., Ltd., now recruiting.","summary":"Study to Evaluate Efficacy and Safety of HH2853 in Relapsed/Refractory Peripheral T-cell Lymphoma is a phase 1/2 interventional study registered as NCT06909877 by Haihe Biopharma Co., Ltd., with 100 participants planned, started 2022-07-27 and due to reach its primary completion in 2025-10-31. Interventions recorded: HH2853 Tablets.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06909877","url":"https://clinicaltrials.gov/study/NCT06909877"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["haihe-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06909877","phase":"1/2","setting":"An Open-label, Multinational, Multicenter, Single-arm Phase Ⅰb/Ⅱ Study to Evaluate Efficacy and Safety of Oral HH2853, a Selective EZH1/2 Inhibitor, in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma","sponsor":"Haihe Biopharma Co., Ltd.","started":"2022-07-27","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01697384","kind":"trial","name":"Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Histrelin in Prostate cancer, run by Endo USA Inc., a Keenova Therapeutics Company, completed.","summary":"Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer is a phase 3 interventional study registered as NCT01697384 by Endo USA Inc., a Keenova Therapeutics Company, with 138 participants recorded, started 2000-04 and reaching its primary completion in 2003-08. Interventions recorded: histrelin acetate. Conditions recorded: Prostate Cancer, Adenocarcinoma of the Prostate.\n\nLinked to the drug Histrelin because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01697384","url":"https://clinicaltrials.gov/study/NCT01697384"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["histrelin"],"companies":["endo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01697384","phase":"3","setting":"Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer","sponsor":"Endo USA Inc., a Keenova Therapeutics Company","started":"2000-04","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03936153","kind":"trial","name":"Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)","aka":[],"tldr":"A phase 2 trial of Abexinostat in diffuse large b-cell lymphoma, run by Xynomic Pharmaceuticals, Inc., now recruiting.","summary":"Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) is a phase 2 interventional study registered as NCT03936153 by Xynomic Pharmaceuticals, Inc., with 170 participants planned, started 2020-01-20 and due to reach its primary completion in 2026-07-31. Interventions recorded: abexinostat. Conditions listed: Diffuse Large B-cell Lymphoma (DLBCL). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03936153","url":"https://clinicaltrials.gov/study/NCT03936153"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["abexinostat"],"companies":["xynomic-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03936153","phase":"2","setting":"An Open-label, Single-arm, Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Abexinostat as Monotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)","sponsor":"Xynomic Pharmaceuticals, Inc.","started":"2020-01-20","startedType":"actual","enrolled":170,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05583552","kind":"trial","name":"Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy","aka":["IMpress"],"tldr":"A phase 2 trial of Imetelstat in myelodysplastic syndromes / neoplasms and acute myeloid leukaemia, run by GCP-Service International West GmbH, active and no longer recruiting.","summary":"Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy is a phase 2 interventional study registered as NCT05583552 by GCP-Service International West GmbH, with 46 participants enrolled, started 2023-06-05 and due to reach its primary completion in 2025-03-27. Interventions recorded: Imetelstat sodium. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05583552","url":"https://clinicaltrials.gov/study/NCT05583552"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mds","aml","mds-higher-risk"],"sections":[],"technologies":["antisense-sirna"],"targets":[],"drugs":["imetelstat"],"companies":["geron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05583552","phase":"2","setting":"A Phase II Study Evaluating the Efficacy and Safety of Imetelstat in Patients With HR Myelodysplastic Syndromes or AML Failing HMA-based Therapy","sponsor":"GCP-Service International West GmbH","started":"2023-06-05","startedType":"actual","yearReported":2026,"enrolled":46,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Hematological Response Rate of Participants After Treatment With Imetelstat","primary":true,"unit":"participants","arms":[{"name":"Imetelstat Sodium (1 Treatment / Cycle)","n":23,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2026-05-12), not from a publication"},{"name":"Imetelstat Sodium (2 Treatments / Cycle)","n":23,"value":1}],"source":"https://clinicaltrials.gov/study/NCT05583552?tab=results"}]},{"id":"nct05269316","kind":"trial","name":"Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of IMP9064 in advanced solid tumours, run by Impact Therapeutics, Inc., now recruiting.","summary":"Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05269316 by Impact Therapeutics, Inc., with 61 participants planned, started 2022-02-11 and due to reach its primary completion in 2026-12-31. Interventions recorded: IMP9064.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05269316","url":"https://clinicaltrials.gov/study/NCT05269316"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["impact-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05269316","phase":"1/2","setting":"A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation and Dose-expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of the ATR Inhibitor IMP9064 Monotherapy and in Combination With PARP Inhibitor Senaparib in Patients With Advanced Solid Tumors","sponsor":"Impact Therapeutics, Inc.","started":"2022-02-11","startedType":"actual","enrolled":61,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07214779","kind":"trial","name":"Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression","aka":["MAESTRA 2"],"tldr":"A phase 3 trial testing INCB123667 in ovarian cancer, now recruiting.","summary":"Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression is a phase 3 interventional study registered as NCT07214779, led by Incyte with ENGOT Foundation and GOG Foundation, and recruiting on the registry. Official title: A Phase 3, Randomised, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression. Planned enrolment is 466 participants (estimated). The study started in 2025-12-09 and primary completion is expected in 2028-11-15. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07214779","url":"https://clinicaltrials.gov/study/NCT07214779"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["incb123667"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07214779","phase":"3","setting":"A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression","sponsor":"Incyte","started":"2025-12-09","startedType":"actual","enrolled":466,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04384484","kind":"trial","name":"Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lym","aka":["LOTIS-5"],"tldr":"A phase 3 trial of Loncastuximab tesirine, Rituximab, Gemcitabine in diffuse large b-cell lymphoma, run by ADC Therapeutics S.A., active and no longer recruiting.","summary":"Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma is a phase 3 interventional study registered as NCT04384484 by ADC Therapeutics S.A., with 440 participants enrolled, started 2020-09-16 and due to reach its primary completion in 2026-03-31. Interventions recorded: Loncastuximab Tesirine, Rituximab, Gemcitabine, Oxaliplatin. Conditions listed: Relapsed Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04384484","url":"https://clinicaltrials.gov/study/NCT04384484"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["adc","monoclonal-antibody"],"targets":[],"drugs":["zynlonta","rituximab","gemcitabine","capox"],"companies":["adc-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04384484","phase":"3","setting":"A Phase 3 Randomized Study of Loncastuximab Tesirine Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5)","sponsor":"ADC Therapeutics S.A.","started":"2020-09-16","startedType":"actual","enrolled":440,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04711135","kind":"trial","name":"Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs","aka":["NETTER-P"],"tldr":"A phase 2 trial of Lutetium-177 dotatate in pheochromocytoma and paraganglioma, run by Advanced Accelerator Applications, active and no longer recruiting.","summary":"Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs is a phase 2 interventional study registered as NCT04711135 by Advanced Accelerator Applications, with 11 participants enrolled, started 2022-08-31 and due to reach its primary completion in 2024-03-12. Interventions recorded: Lutetium [177Lu] oxodotreotide/dotatate. Conditions listed: Gastroenteropancreatic Neuroendocrine Tumors, Pheochromocytoma, Paraganglioma. Results were posted on ClinicalTrials.gov in 2024; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04711135","url":"https://clinicaltrials.gov/study/NCT04711135"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pheochromocytoma-paraganglioma"],"sections":[],"technologies":["radioligand-therapy"],"targets":[],"drugs":["lutathera"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04711135","phase":"2","setting":"A Multicenter Open-label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas (PPGL)","sponsor":"Advanced Accelerator Applications","started":"2022-08-31","startedType":"actual","yearReported":2024,"enrolled":11,"enrolledBasis":"registry","outcomes":[{"endpoint":"Absorbed Radiation Doses in Target Organ, Total Body","primary":true,"unit":"gy/gbq","arms":[{"name":"GEP-NET","n":4,"value":0.04,"note":"SD 0.013; Figures from the ClinicalTrials.gov results section (first posted 2024-11-27), not from a publication"},{"name":"PPGL","n":6,"value":0.041,"note":"SD 0.0073"}],"source":"https://clinicaltrials.gov/study/NCT04711135?tab=results"}]},{"id":"nct05168566","kind":"trial","name":"Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Sutetinib Maleate Capsule in non-small-cell lung cancer, run by Teligene US, now recruiting.","summary":"Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT05168566 by Teligene US, with 99 participants planned, started 2022-09-01 and due to reach its primary completion in 2027-12. Interventions recorded: Sutetinib Maleate Capsule.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05168566","url":"https://clinicaltrials.gov/study/NCT05168566"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":["egfr"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05168566-j-thorac-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05168566","phase":"2","setting":"A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)","sponsor":"Teligene US","started":"2022-09-01","startedType":"actual","enrolled":99,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07219238","kind":"trial","name":"Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, o","aka":["PERISCOPE"],"tldr":"A phase 2/3 trial of FAP-2286 in colorectal cancer and ovarian cancer, run by GE Healthcare, now recruiting.","summary":"Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE) is a phase 2/3 interventional study registered as NCT07219238 by GE Healthcare, with 175 participants planned, started 2026-10 and due to reach its primary completion in 2029-06. Interventions recorded: GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT). Conditions listed: Colorectal Cancer, Gastric Cancers, Ovarian Cancers, Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07219238","url":"https://clinicaltrials.gov/study/NCT07219238"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","ovarian","pancreatic"],"sections":[],"technologies":["fapi-pet","radioligand-therapy"],"targets":[],"drugs":["fap-2286"],"companies":["ge-healthcare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07219238","phase":"2/3","setting":"A Phase 2/3, Multicenter, Open-Label, Non-Randomized Study to Evaluate Diagnostic Performance of GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) for Detection of Peritoneal Carcinomatosis (PC) in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)","sponsor":"GE Healthcare","started":"2026-10","startedType":"estimated","enrolled":175,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06784752","kind":"trial","name":"Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET","aka":["NETTER-3"],"tldr":"A phase 3 trial of [177Lu]Lu-DOTA-TATE in pancreatic ductal adenocarcinoma, run by Novartis Pharmaceuticals, now recruiting.","summary":"Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET is a phase 3 interventional study registered as NCT06784752 by Novartis Pharmaceuticals, with 240 participants planned, started 2025-05-30 and due to reach its primary completion in 2028-12-08. Interventions recorded: [177Lu]Lu-DOTA-TATE and Octreotide LAR.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06784752","url":"https://clinicaltrials.gov/study/NCT06784752"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["advanced-accelerator-applications"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06784752","phase":"3","setting":"A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients Newly Diagnosed With Grade 1 and Grade 2 (Ki-67 <10%) Advanced GEP-NET With High Disease Burden (NETTER-3)","sponsor":"Novartis Pharmaceuticals","started":"2025-05-30","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04342910","kind":"trial","name":"Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC","aka":[],"tldr":"A phase 3 trial of Camrelizumab and Rivoceranib (apatinib) in gastric & gastro-oesophageal junction cancer, run by Jiangsu HengRui Medicine Co., Ltd., now recruiting.","summary":"Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC is a phase 3 interventional study registered as NCT04342910 by Jiangsu HengRui Medicine Co., Ltd., with 550 participants planned, started 2020-09-21 and due to reach its primary completion in 2026-04-01. Interventions recorded: camrelizumab, Apatinib Mesylate, Paclitaxel and Irinotecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04342910","url":"https://clinicaltrials.gov/study/NCT04342910"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["camrelizumab","rivoceranib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04342910","phase":"3","setting":"A Study of Camrelizumab (SHR-1210) Combined With Apatinib Versus Paclitaxel or Irinotecan in Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma Progressed After First-line Chemotherapy","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","started":"2020-09-21","startedType":"actual","enrolled":550,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06207656","kind":"trial","name":"Study to Evaluate the Efficacy and Safety of Cetuximab in Combination with Encorafenib Plus Binimetinib As Induction Treatment in BRAF V600E Mutated MSS Initial","aka":["CEBBRA"],"tldr":"A phase 2 trial in colorectal cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD), now recruiting.","summary":"Study to Evaluate the Efficacy and Safety of Cetuximab in Combination with Encorafenib Plus Binimetinib As Induction Treatment in BRAF V600E Mutated MSS Initially Resectable or Potentially Resectable Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT06207656 by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD), with a registry enrolment figure of 70 participants, started 2024-04-16 and due to reach its primary completion in 2029-04-01. Interventions recorded: EBC. Conditions listed: Colorectal Cancer. Primary outcome: Efficacy of cetuximab in combination with encorafenib plus binimetinib as induction therapy for the treatment of BRAF-V600E mutated MSS aCRC to perform radical treatment of the primary and/or metastases. Colorectal eligibility wording from the registry: \"Participants with histologically or cytologically confirmed colorectal adenocarcinoma\". Sites: Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06207656","url":"https://clinicaltrials.gov/study/NCT06207656"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","braf-v600e-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["pierre-fabre"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06207656","phase":"2","setting":"Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Cetuximab in Combination with Encorafenib Plus Binimetinib As Induction Treatment in BRAF V600E Mutated MSS Initially Resectable or Potentially Resectable Advanced Colorectal Cancer","sponsor":"Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)","started":"2024-04-16","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03972488","kind":"trial","name":"Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET","aka":["NETTER-2"],"tldr":"A phase 3 trial of Lutetium-177 dotatate in pancreatic ductal adenocarcinoma, run by Advanced Accelerator Applications, active and no longer recruiting.","summary":"Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET is a phase 3 interventional study registered as NCT03972488 by Advanced Accelerator Applications, with 226 participants enrolled, started 2020-01-08 and due to reach its primary completion in 2023-07-20. Interventions recorded: Lutathera, 30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot), 2.5% Lys-Arg sterile amino acid solution and High dose 60 mg octreotide long-acting repeatable. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03972488","url":"https://clinicaltrials.gov/study/NCT03972488"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine","small-intestinal-net","pancreatic-net","grade-3-net"],"sections":[],"technologies":["radioligand-therapy"],"targets":[],"drugs":["lutathera"],"companies":["advanced-accelerator-applications"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03972488","phase":"3","setting":"A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET","sponsor":"Advanced Accelerator Applications","started":"2020-01-08","startedType":"actual","yearReported":2024,"enrolled":226,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) Per Central Assessment","primary":true,"unit":"months","arms":[{"name":"Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm)","n":151,"value":22.8,"note":"95% CI 19.4 to NA; Figures from the ClinicalTrials.gov results section (first posted 2024-10-10), not from a publication"},{"name":"Octreotide LAR 60 mg (Control Arm)","n":75,"value":8.5,"note":"95% CI 7.7 to 13.8"}],"hr":0.276,"ci":[0.182,0.418],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT03972488?tab=results"},{"endpoint":"Overall Response Rate (ORR) Per Central Assessment (Key Secondary)","unit":"%","arms":[{"name":"Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm)","n":151,"value":43,"note":"95% CI 35.0 to 51.3; Figures from the ClinicalTrials.gov results section (first posted 2024-10-10), not from a publication"},{"name":"Octreotide LAR 60 mg (Control Arm)","n":75,"value":9.3,"note":"95% CI 3.8 to 18.3"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT03972488?tab=results"}]},{"id":"nct03635021","kind":"trial","name":"Study to Evaluate the Efficacy of FOLFOX + Panitumumab Followed by FOLFIRI + Bevacizumab (Sequence 1) Versus FOLFOX + Bevacizumab Followed by FOLFIRI + Panitumu","aka":["CR-SEQUENCE"],"tldr":"A phase 3 trial of panitumumab and bevacizumab (glioblastoma use) in colorectal cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD), active but no longer recruiting.","summary":"Study to Evaluate the Efficacy of FOLFOX + Panitumumab Followed by FOLFIRI + Bevacizumab (Sequence 1) Versus FOLFOX + Bevacizumab Followed by FOLFIRI + Panitumumab (Sequence 2) in Untreated Patients With Wild-type RAS Metastatic, Primary Left-sided, Unresectable Colorectal Cancer is a phase 3, randomised interventional study registered as NCT03635021 by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD), with a registry enrolment figure of 419 participants, started 2018-10-15 and due to reach its primary completion in 2025-06-28. Interventions recorded: FOLFOX regimen; Panitumumab; Bevacizumab; FOLFIRI regimen. Conditions listed: Colorectal Cancer. Primary outcome: Progression-free survival rate at 35 months. Colorectal eligibility wording from the registry: \"Histologically confirmed adenocarcinoma of the left colon or rectum (originate in the splenic flexure, descending colon, sigmoid colon, or rectum) in patients with unresectable (not amenable to radical surgery of metastases at the study inclusion) metastatic (M1) disease\". Sites: Spain. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03635021","url":"https://clinicaltrials.gov/study/NCT03635021"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["panitumumab","bevacizumab-glioma"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03635021","phase":"3","setting":"Phase III Randomized Sequential Open-label Study to Evaluate the Efficacy of FOLFOX + Panitumumab Followed by FOLFIRI + Bevacizumab (Sequence 1) Versus FOLFOX + Bevacizumab Followed by FOLFIRI + Panitumumab (Sequence 2) in Untreated Patients With Wild-type RAS Metastatic, Primary Left-sided, Unresectable Colorectal Cancer: The CR-SEQUENCE","sponsor":"Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)","started":"2018-10-15","startedType":"actual","enrolled":419,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06033586","kind":"trial","name":"Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera","aka":["THRIVE"],"tldr":"A phase 3 trial of Rusfertide in myeloproliferative neoplasms, run by Protagonist Therapeutics, Inc., active and no longer recruiting.","summary":"Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera is a phase 3 interventional study registered as NCT06033586 by Protagonist Therapeutics, Inc., with 46 participants enrolled, started 2024-01-22 and due to reach its primary completion in 2026-04-01. Interventions recorded: Open-label rusfertide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06033586","url":"https://clinicaltrials.gov/study/NCT06033586"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms"],"sections":[],"technologies":["peptide-drug-conjugate"],"targets":[],"drugs":["rusfertide"],"companies":["protagonist-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06033586","phase":"3","setting":"An Extension Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera (THRIVE)","sponsor":"Protagonist Therapeutics, Inc.","started":"2024-01-22","startedType":"actual","enrolled":46,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07341100","kind":"trial","name":"Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin on the PK of SKB264 in OC","aka":[],"tldr":"A phase 2 trial of SKB264 in ovarian cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., active and no longer recruiting.","summary":"Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin on the PK of SKB264 in OC is a phase 2 interventional study registered as NCT07341100 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 20 participants enrolled, started 2026-01-16 and due to reach its primary completion in 2028-01. Interventions recorded: SKB264 and Clarithromycin.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07341100","url":"https://clinicaltrials.gov/study/NCT07341100"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07341100","phase":"2","setting":"A Multicenter, Open-label Clinical Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin, a Potent CYP3A Inhibitor, on the Pharmacokinetics of SKB264 in Patients With Ovarian Epithelial Cancer","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","started":"2026-01-16","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05118776","kind":"trial","name":"Study to Evaluate the Safety and Efficacy of ASC40 Tablets in Combination With Bevacizumab in Subjects With rGBM","aka":[],"tldr":"A phase 3 trial testing ASC40 in glioma & glioblastoma, active and no longer recruiting.","summary":"Study to Evaluate the Safety and Efficacy of ASC40 Tablets in Combination With Bevacizumab in Subjects With rGBM is a phase 3 interventional study registered as NCT05118776, led by Ascletis Pharmaceuticals, and active but no longer recruiting on the registry. Official title: A Phase III Randomised, Double-blind, Placebo-controlled, Multi-centre Trial to Evaluate Safety and Efficacy pf ASC40 Tablets Combined With Bevacizumab in Subjects With Recurrent Glioblastoma. Planned enrolment is 136 participants (actual). The study started in 2022-01-21 and primary completion is expected in 2025-06. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05118776","url":"https://clinicaltrials.gov/study/NCT05118776"}],"tags":["ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":["asc40"],"companies":["ascletis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05118776","phase":"3","setting":"A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate Safety and Efficacy pf ASC40 Tablets Combined With Bevacizumab in Subjects With Recurrent Glioblastoma","sponsor":"Ascletis Pharmaceuticals","started":"2022-01-21","startedType":"actual","enrolled":136,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05283226","kind":"trial","name":"Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck","aka":[],"tldr":"A phase 2 trial of Paclitaxel / nab-paclitaxel in head and neck squamous cell carcinoma, run by NATCO Pharma Ltd., now recruiting.","summary":"Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy is a phase 2 interventional study registered as NCT05283226 by NATCO Pharma Ltd., with 21 participants planned, started 2022-09-30 and due to reach its primary completion in 2026-12-30. Interventions recorded: NRC-2694-A, Paclitaxel. Conditions listed: Carcinoma, Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05283226","url":"https://clinicaltrials.gov/study/NCT05283226"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["paclitaxel"],"companies":["natco"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05283226","phase":"2","setting":"A Phase 2 Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy","sponsor":"NATCO Pharma Ltd.","started":"2022-09-30","startedType":"actual","enrolled":21,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05429268","kind":"trial","name":"Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (","aka":["firmMIND"],"tldr":"A phase 3 trial of Tafasitamab, Lenalidomide in diffuse large b-cell lymphoma, run by Incyte Corporation, active and no longer recruiting.","summary":"Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND) is a phase 3 interventional study registered as NCT05429268 by Incyte Corporation, with 82 participants enrolled, started 2022-12-23 and due to reach its primary completion in 2026-03-30. Interventions recorded: Tafasitamab, Lenalidomide. Conditions listed: Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05429268","url":"https://clinicaltrials.gov/study/NCT05429268"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["tafasitamab","lenalidomide"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05429268","phase":"3","setting":"A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","sponsor":"Incyte Corporation","started":"2022-12-23","startedType":"actual","enrolled":82,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04827953","kind":"trial","name":"Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic C","aka":["NUMANTIA"],"tldr":"A phase 1/2 trial of Gemcitabine, Paclitaxel / nab-paclitaxel in pancreatic ductal adenocarcinoma, run by Nelum Corp, active and no longer recruiting.","summary":"Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer is a phase 1/2 interventional study registered as NCT04827953 by Nelum Corp, with 28 participants enrolled, started 2021-09-01 and due to reach its primary completion in 2025-04. Interventions recorded: Gemcitabine, Nab paclitaxel, NLM-001, Zalifrelimab. Conditions listed: Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04827953","url":"https://clinicaltrials.gov/study/NCT04827953"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04827953","phase":"1/2","setting":"Phase Ib/IIa Study to Evaluate Safety and Efficacy of Treatment With the Hedgehog Inhibitor NLM-001 and Chemotherapy (Gemcitabine and Nab-Paclitaxel) Plus Zalifrelimab as First Line Treatment in Patients With Advanced Pancreatic Cancer","sponsor":"Nelum Corp","started":"2021-09-01","startedType":"actual","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07427394","kind":"trial","name":"Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer","aka":["SERENA-1b"],"tldr":"A phase 2 trial of Camizestrant and Atirmociclib in advanced solid tumours, run by AstraZeneca, now recruiting.","summary":"Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer is a phase 2 interventional study registered as NCT07427394 by AstraZeneca, with 24 participants planned, started 2026-05-06 and due to reach its primary completion in 2027-12-28. Interventions recorded: Camizestrant and Atirmociclib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07427394","url":"https://clinicaltrials.gov/study/NCT07427394"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy"],"targets":[],"drugs":["camizestrant","atirmociclib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07427394","phase":"2","setting":"A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)","sponsor":"AstraZeneca","started":"2026-05-06","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04581512","kind":"trial","name":"Study to Evaluate the Safety and Tolerability of EP0042","aka":[],"tldr":"A phase 1/2 trial of Venetoclax and Azacitidine in acute myeloid leukaemia, chronic myelomonocytic leukaemia and MDS/MPN overlap neoplasms and myelodysplastic syndromes / neoplasms, run by Ellipses Pharma, now recruiting.","summary":"Study to Evaluate the Safety and Tolerability of EP0042 is a phase 1/2 interventional study registered as NCT04581512 by Ellipses Pharma, with 70 participants planned, started 2020-11-02 and due to reach its primary completion in 2027-12. Interventions recorded: EP0042, Venetoclax and Azacitidine (AZA).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04581512","url":"https://clinicaltrials.gov/study/NCT04581512"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","cmml","mds"],"sections":[],"technologies":[],"targets":[],"drugs":["venetoclax","azacitidine"],"companies":["ellipses-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04581512","phase":"1/2","setting":"A Modular, Multipart, Multi-arm, Open-label, Phase I/IIa Study to Evaluate the Safety and Tolerability of EP0042 Alone and in Combination With Anti-cancer Treatments in Patients With Advanced Malignancies","sponsor":"Ellipses Pharma","started":"2020-11-02","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06922591","kind":"trial","name":"Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients","aka":[],"tldr":"A phase 1/2 trial of TNG462, Zoldonrasib, Daraxonrasib in pancreatic ductal adenocarcinoma, run by Tango Therapeutics, Inc., now recruiting.","summary":"Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients is a phase 1/2 interventional study registered as NCT06922591 by Tango Therapeutics, Inc., with 183 participants planned, started 2025-05-31 and due to reach its primary completion in 2027-06. Interventions recorded: TNG462, RMC-9805, RMC-6236, mFOLFIRINOX, gemcitabine/nab-paclitaxel. Conditions listed: PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, NSCLC, RAS Mutation. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06922591","url":"https://clinicaltrials.gov/study/NCT06922591"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["tng462","zoldonrasib","daraxonrasib","folfirinox","gemcitabine","paclitaxel"],"companies":["tango-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06922591","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open-Label Study to Evaluate Safety, Tolerability & Antitumor Activity of TNG462 in Combination With Other Agents in Patients With Pancreatic Cancer With MTAP Loss and Pancreatic or Non-Small Cell Lung Cancer With MTAP Loss & RAS Mutation","sponsor":"Tango Therapeutics, Inc.","started":"2025-05-31","startedType":"actual","enrolled":183,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04954001","kind":"trial","name":"Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1","aka":[],"tldr":"A phase 1/2 trial of FCN-159 in childhood cancers, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., active and no longer recruiting.","summary":"Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 is a phase 1/2 interventional study registered as NCT04954001 by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., with 160 participants enrolled, started 2021-03-26 and due to reach its primary completion in 2025-02-28. Interventions recorded: FCN-159.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04954001","url":"https://clinicaltrials.gov/study/NCT04954001"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["childhood-cancers"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shanghai-fosun-pharmaceutical-industrial-development"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04954001","phase":"1/2","setting":"A Multi-center, Open-label, Single-arm Phase I Dose-escalation and Phase II Dose-expansion Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1","sponsor":"Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.","started":"2021-03-26","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06888843","kind":"trial","name":"Study to Evaluate the Use of Capecitabine in Monotherapy and in Combination With Oxaliplatin in Elderly Patients as Adjuvant Chemotherapy for Locally Advanced C","aka":["AHTCRR-1"],"tldr":"A phase 2 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Nizhny Novgorod Regional Clinical Oncology Center, now recruiting.","summary":"Study to Evaluate the Use of Capecitabine in Monotherapy and in Combination With Oxaliplatin in Elderly Patients as Adjuvant Chemotherapy for Locally Advanced Colorectal Cancer. is a phase 2, randomised interventional study registered as NCT06888843 by Nizhny Novgorod Regional Clinical Oncology Center, with a registry enrolment figure of 160 participants, started 2025-02-01 and due to reach its primary completion in 2028-02-01. Interventions recorded: Capecitabine; Oxaliplatin. Conditions listed: Colorectal Cancer. Primary outcome: The disease free survival. Colorectal eligibility wording from the registry: \"Morphologically confirmed diagnosis of colorectal cancer;\". Sites: Russia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06888843","url":"https://clinicaltrials.gov/study/NCT06888843"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06888843","phase":"2","setting":"A Single-center, Open-label, Randomized Phase II Study to Evaluate the Use of Capecitabine in Monotherapy and in Combination With Oxaliplatin in Elderly Patients as Adjuvant Chemotherapy for Locally Advanced Colorectal Cancer.","sponsor":"Nizhny Novgorod Regional Clinical Oncology Center","started":"2025-02-01","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04665206","kind":"trial","name":"Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Osimertinib, Pemetrexed, Carboplatin in mesothelioma, run by Vivace Therapeutics, Inc, now recruiting.","summary":"Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT04665206 by Vivace Therapeutics, Inc, with 434 participants planned, started 2021-03-24 and due to reach its primary completion in 2029-11-02. Interventions recorded: VT3989, Nivolumab & Ipilimumab, Osimertinib, Pemetrexed/Carboplatin. Conditions listed: Solid Tumor, Adult, Mesothelioma, NSCLC. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04665206","url":"https://clinicaltrials.gov/study/NCT04665206"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mesothelioma"],"sections":[],"technologies":[],"targets":[],"drugs":["osimertinib","pemetrexed","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04665206","phase":"1/2","setting":"Phase I/II, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients With Locally Advanced or Metastatic Solid Tumors","sponsor":"Vivace Therapeutics, Inc","started":"2021-03-24","startedType":"actual","enrolled":434,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05727904","kind":"trial","name":"Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.","aka":[],"tldr":"A phase 3 trial of Pembrolizumab in melanoma, run by Iovance Biotherapeutics, Inc., now recruiting.","summary":"Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma. is a phase 3 interventional study registered as NCT05727904 by Iovance Biotherapeutics, Inc., with 670 participants planned, started 2023-03-30 and due to reach its primary completion in 2028-03-01. Interventions recorded: Lifileucel plus Pembrolizumab, Pembrolizumab with Optional Crossover Period. Conditions listed: Metastatic Melanoma, Unresectable Melanoma, Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05727904","url":"https://clinicaltrials.gov/study/NCT05727904"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["iovance"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05727904","phase":"3","setting":"A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma","sponsor":"Iovance Biotherapeutics, Inc.","started":"2023-03-30","startedType":"actual","enrolled":670,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05725200","kind":"trial","name":"Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of Patient-derived organoids in Colorectal cancer, run by Oslo University Hospital, now recruiting.","summary":"Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer is a phase 2 interventional study registered as NCT05725200 by Oslo University Hospital, with 40 participants planned, started 2022-09-27 and due to reach its primary completion in 2038-12-31. Interventions recorded: Alectinib, Cetuximab, Crizotinib, Dasatinib, Everolimus, Encorafenib, Gemcitabine, Idelalisib, Larotrectinib, Methotrexate, Palbociclib, Panobinostat, Pembrolizumab, Petrozumab, Trastuzumab, Talazoparib, Venetoclax. Conditions recorded: Metastatic Colorectal Cancer.\n\nLinked to the technology Patient-derived organoids because the registry's title names it (\"patient derived organoids\") and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05725200","url":"https://clinicaltrials.gov/study/NCT05725200"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["organoids"],"targets":[],"drugs":["alectinib","cetuximab","crizotinib","dasatinib","everolimus","encorafenib","gemcitabine","idelalisib","larotrectinib","methotrexate","palbociclib","panobinostat","pembrolizumab","trastuzumab","talazoparib","venetoclax"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05725200","phase":"2","setting":"Study to Investigate Outcome of Individualized Treatment Based on Pharmacogenomic Profiling & Ex Vivo Drug Sensitivity Testing of Patient-derived Organoids in Patients With Metastatic Colorectal Cancer","sponsor":"Oslo University Hospital","started":"2022-09-27","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04349436","kind":"trial","name":"Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies","aka":["ARTACUS"],"tldr":"A phase 1/2 trial of RP1, intra-tumoral injection, oncolytic virus in merkel cell carcinoma, basal cell carcinoma and cutaneous squamous cell carcinoma, run by Replimune, Inc., active and no longer recruiting.","summary":"Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies is a phase 1/2 interventional study registered as NCT04349436 by Replimune, Inc., with 69 participants enrolled, started 2020-05-15 and due to reach its primary completion in 2029-07. Interventions recorded: RP1, intra-tumoral injection, oncolytic virus.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04349436","url":"https://clinicaltrials.gov/study/NCT04349436"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["merkel-cell-carcinoma","basal-cell-carcinoma","cutaneous-scc","locally-advanced-bcc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["replimune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04349436","phase":"1/2","setting":"An Open-Label, Multicenter, Phase 1B/2 Study of RP1 in Solid Organ and Hematopoietic Cell Transplant Recipients With Advanced Cutaneous Malignancies (ARTACUS)","sponsor":"Replimune, Inc.","started":"2020-05-15","startedType":"actual","enrolled":69,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06234098","kind":"trial","name":"Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of AT-1965 Liposome Injection in advanced solid tumours, run by Alyssum Therapeutics, now recruiting.","summary":"Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors is a phase 1/2 interventional study registered as NCT06234098 by Alyssum Therapeutics, with 100 participants planned, started 2024-02-13 and due to reach its primary completion in 2026-12. Interventions recorded: AT-1965 Liposome Injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06234098","url":"https://clinicaltrials.gov/study/NCT06234098"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06234098","phase":"1/2","setting":"A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors","sponsor":"Alyssum Therapeutics","started":"2024-02-13","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01499303","kind":"trial","name":"Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer","aka":[],"tldr":"A phase 2 trial of Fostamatinib in Diffuse large B-cell lymphoma, run by AstraZeneca, completed.","summary":"Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer is a phase 2 interventional study registered as NCT01499303 by AstraZeneca, with 101 participants recorded, started 2011-12 and reaching its primary completion in 2013-10. Interventions recorded: Fostamatinib. Conditions recorded: Diffuse Large B-Cell Lymphoma.\n\nLinked to the drug Fostamatinib because the registry names it among its interventions and Diffuse large B-cell lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01499303","url":"https://clinicaltrials.gov/study/NCT01499303"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":["fostamatinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01499303","phase":"2","setting":"Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma(DLBCL)","sponsor":"AstraZeneca","started":"2011-12","yearReported":2014,"enrolled":101,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate","primary":true,"unit":"participants","arms":[{"name":"100mg BID","n":21,"value":2,"note":"95% CI 1.17 to 30.38; Figures from the ClinicalTrials.gov results section (first posted 2014-08-22), not from a publication"},{"name":"200mg BID","n":47,"value":0,"note":"95% CI 0.00 to 7.55"}],"source":"https://clinicaltrials.gov/study/NCT01499303?tab=results"}]},{"id":"nct04557449","kind":"trial","name":"Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors","aka":[],"tldr":"A phase 2 trial of Atirmociclib, Letrozole, Fulvestrant in prostate cancer, run by Pfizer, active and no longer recruiting.","summary":"Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors is a phase 2 interventional study registered as NCT04557449 by Pfizer, with 362 participants enrolled, started 2020-09-23 and due to reach its primary completion in 2026-09-23. Interventions recorded: PF-07220060, Letrozole, Fulvestrant, Midazolam, Enzalutamide. Conditions listed: Liposarcoma, Prostate Cancer, Breast Neoplasms, Adenocarcinoma of Lung. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04557449","url":"https://clinicaltrials.gov/study/NCT04557449"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["atirmociclib","letrozole","fulvestrant","enzalutamide"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04557449","phase":"2","setting":"A PHASE 1/2A STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS","sponsor":"Pfizer","started":"2020-09-23","startedType":"actual","enrolled":362,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05317416","kind":"trial","name":"Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant","aka":["MagnetisMM-7"],"tldr":"A phase 3 trial of Elranatamab, Lenalidomide in multiple myeloma, run by Pfizer, active and no longer recruiting.","summary":"Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant is a phase 3 interventional study registered as NCT05317416 by Pfizer, with 854 participants enrolled, started 2022-03-25 and due to reach its primary completion in 2027-08-04. Interventions recorded: Elranatamab, Lenalidomide, Lenalidomide, Elranatamab. Conditions listed: Multiple Myeloma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05317416","url":"https://clinicaltrials.gov/study/NCT05317416"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["protac-degrader","t-cell-engager"],"targets":[],"drugs":["elranatamab","lenalidomide"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05317416","phase":"3","setting":"A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION","sponsor":"Pfizer","started":"2022-03-25","startedType":"actual","enrolled":854,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06904235","kind":"trial","name":"Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC)","aka":[],"tldr":"A phase 2 trial of Palonosetron, Ondansetron and Aprepitant (and fosaprepitant) in childhood cancers, run by Helsinn Healthcare SA, now recruiting.","summary":"Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC) is a phase 2 interventional study registered as NCT06904235 by Helsinn Healthcare SA, with 95 participants planned, started 2025-07-07 and due to reach its primary completion in 2027-10. Interventions recorded: IV NEPA (fosnetupitant/palonosetron), Reference Treatment: IV ondansetron infusion and Reference Treatment: IV fosaprepitant infusion.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06904235","url":"https://clinicaltrials.gov/study/NCT06904235"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["childhood-cancers"],"sections":[],"technologies":["antiemetic-therapy"],"targets":[],"drugs":["palonosetron","ondansetron","aprepitant"],"companies":["helsinn"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06904235","phase":"2","setting":"A Multicentre, Multinational, Pharmacokinetic, Safety, and Efficacy Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC). A 2-part Study With Phase 2, Open-label, Randomised, Single-dose IV NEPA vs Fosaprepitant/Ondansetron in Single-day HEC and Repeated-dose IV NEPA in Multi-day HEC (Part I, Single Cycle) and With Phase 3, Double-blind, Randomised, Repeated-dose IV NEPA vs Fosaprepitant/Ondansetron in Multi-day HEC (Part II, Repeated Cycles)","sponsor":"Helsinn Healthcare SA","started":"2025-07-07","startedType":"actual","enrolled":95,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05676931","kind":"trial","name":"Study With Various Immunotherapy Treatments in Participants With Lung Cancer","aka":["EDGE-Lung"],"tldr":"A phase 2 trial of Domvanalimab, Quemliclustat, Zimberelimab in non-small-cell lung cancer and small-cell lung cancer, run by Gilead Sciences, active and no longer recruiting.","summary":"Study With Various Immunotherapy Treatments in Participants With Lung Cancer is a phase 2 interventional study registered as NCT05676931 by Gilead Sciences, with 400 participants planned, started 2023-02-21 and due to reach its primary completion in 2027-12. Interventions recorded: Domvanalimab, Quemliclustat, Zimberelimab, Docetaxel, Platinum-Based Doublet. Conditions listed: Advanced Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05676931","url":"https://clinicaltrials.gov/study/NCT05676931"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["domvanalimab","quemliclustat","zimberelimab","docetaxel"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05676931","phase":"2","setting":"A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer","sponsor":"Gilead Sciences","started":"2023-02-21","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06998940","kind":"trial","name":"Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations","aka":[],"tldr":"A phase 3 trial of fluorouracil (5-FU), gemcitabine, fOLFIRI (5-FU, leucovorin, irinotecan), fLOT (5-FU, leucovorin, oxaliplatin, docetaxel) and other drugs in pancreatic cancer, run by SWOG Cancer Research Network, now recruiting.","summary":"Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations is a phase 3, randomised interventional study registered as NCT06998940 by SWOG Cancer Research Network, with a registry enrolment figure of 94 participants, started 2026-05-13 and due to reach its primary completion in 2029-12-31. Interventions recorded: Biospecimen Collection; Computed Tomography; Fluorouracil; Gemcitabine; Irinotecan; Irinotecan Sucrosofate; Leucovorin; Nab-paclitaxel; Panitumumab; Questionnaire Administration. Conditions listed: Locally Advanced Pancreatic Adenocarcinoma; Metastatic Pancreatic Adenocarcinoma; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma. Primary outcome: Overall survival (OS). Pancreatic eligibility wording from the registry: \"* Participants must have a histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of the pancreas\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06998940","url":"https://clinicaltrials.gov/study/NCT06998940"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac","kras-wild-type-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","gemcitabine","folfiri","flot","nab-paclitaxel","panitumumab"],"companies":["swog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06998940","phase":"3","setting":"Randomized Phase III Study of Second-Line Chemotherapy With or Without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma","sponsor":"SWOG Cancer Research Network","started":"2026-05-13","startedType":"actual","enrolled":94,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07150104","kind":"trial","name":"Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Nirogacestat, Pomalidomide, and Dexamethasone in Participants Wi","aka":[],"tldr":"A phase 1/2 trial of Belantamab mafodotin, Nirogacestat, Pomalidomide in multiple myeloma, run by GlaxoSmithKline, active and no longer recruiting.","summary":"Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Nirogacestat, Pomalidomide, and Dexamethasone in Participants With RRMM is a phase 1/2 interventional study registered as NCT07150104 by GlaxoSmithKline, with 14 participants enrolled, started 2022-08-31 and due to reach its primary completion in 2025-04-17. Interventions recorded: Belantamab mafodotin, Nirogacestat, Pomalidomide, Dexamethasone. Conditions listed: Multiple Myeloma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07150104","url":"https://clinicaltrials.gov/study/NCT07150104"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["adc","antiemetic-therapy","gamma-secretase-inhibitors","kinase-inhibitors","protac-degrader"],"targets":[],"drugs":["belantamab-mafodotin","nirogacestat","pomalidomide","dexamethasone"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07150104","phase":"1/2","setting":"A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5 - Sub-study 7 - Belantamab Mafodotin, Nirogacestat, Pomalidomide, and Dexamethasone in Combination","sponsor":"GlaxoSmithKline","started":"2022-08-31","startedType":"actual","yearReported":2026,"enrolled":14,"enrolledBasis":"registry","outcomes":[{"endpoint":"DE Phase: Number of Participants With Dose Limiting Toxicities (DLTs)","primary":true,"unit":"participants","arms":[{"name":"0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone","n":11,"value":2,"note":"Figures from the ClinicalTrials.gov results section (first posted 2026-06-25), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT07150104?tab=results"},{"endpoint":"DE Phase: Overall Response Rate (ORR)","unit":"%","arms":[{"name":"0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone","n":14,"value":57,"note":"95% CI 28.9 to 82.3; Figures from the ClinicalTrials.gov results section (first posted 2026-06-25), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT07150104?tab=results"}]},{"id":"nct07217119","kind":"trial","name":"Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Feladilimab (GSK3359609) in Participants With RRMM","aka":[],"tldr":"A phase 1/2 trial of Belantamab mafodotin in multiple myeloma, run by GlaxoSmithKline, active and no longer recruiting.","summary":"Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Feladilimab (GSK3359609) in Participants With RRMM is a phase 1/2 interventional study registered as NCT07217119 by GlaxoSmithKline, with 25 participants enrolled, started 2019-11-26 and due to reach its primary completion in 2025-04-17. Interventions recorded: Belantamab mafodotin, Feladilimab. Conditions listed: Multiple Myeloma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07217119","url":"https://clinicaltrials.gov/study/NCT07217119"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["belantamab-mafodotin","feladilimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07217119","phase":"1/2","setting":"A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5 - Sub-study 2 - Belantamab Mafodotin and Feladilimab (GSK3359609) in Combination","sponsor":"GlaxoSmithKline","started":"2019-11-26","startedType":"actual","yearReported":2026,"enrolled":25,"enrolledBasis":"registry","outcomes":[{"endpoint":"Dose Expansion (DE) Phase: Number of Participants With Dose Limiting Toxicities (DLTs)","primary":true,"unit":"participants","arms":[{"name":"1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab","n":9,"value":1,"note":"Figures from the ClinicalTrials.gov results section (first posted 2026-06-25), not from a publication"},{"name":"2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab","n":10,"value":1},{"name":"2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab","n":6,"value":0}],"source":"https://clinicaltrials.gov/study/NCT07217119?tab=results"},{"endpoint":"DE Phase: Overall Response Rate (ORR)","unit":"%","arms":[{"name":"1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab","n":9,"value":44,"note":"95% CI 13.7 to 78.8; Figures from the ClinicalTrials.gov results section (first posted 2026-06-25), not from a publication"},{"name":"2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab","n":10,"value":50,"note":"95% CI 18.7 to 81.3"},{"name":"2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab","n":6,"value":67,"note":"95% CI 22.3 to 95.7"}],"source":"https://clinicaltrials.gov/study/NCT07217119?tab=results"}]},{"id":"nct07217184","kind":"trial","name":"Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM","aka":[],"tldr":"A phase 1/2 trial of Belantamab mafodotin, Isatuximab in multiple myeloma, run by GlaxoSmithKline, active and no longer recruiting.","summary":"Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM is a phase 1/2 interventional study registered as NCT07217184 by GlaxoSmithKline, with 30 participants enrolled, started 2021-07-29 and due to reach its primary completion in 2025-04-17. Interventions recorded: Belantamab mafodotin, Isatuximab. Conditions listed: Multiple Myeloma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07217184","url":"https://clinicaltrials.gov/study/NCT07217184"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["adc","monoclonal-antibody"],"targets":[],"drugs":["belantamab-mafodotin","isatuximab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07217184","phase":"1/2","setting":"A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5- Sub-study 5 - Belantamab Mafodotin and Isatuximab in Combination","sponsor":"GlaxoSmithKline","started":"2021-07-29","startedType":"actual","yearReported":2026,"enrolled":30,"enrolledBasis":"registry","outcomes":[{"endpoint":"Dose Expansion (DE) Phase: Number of Participants With Dose Limiting Toxicities (DLT)","primary":true,"unit":"participants","arms":[{"name":"1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab","n":7,"value":2,"note":"Figures from the ClinicalTrials.gov results section (first posted 2026-06-25), not from a publication"},{"name":"1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab","n":8,"value":0},{"name":"1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab","n":8,"value":1}],"source":"https://clinicaltrials.gov/study/NCT07217184?tab=results"},{"endpoint":"DE Phase: Overall Response Rate (ORR)","unit":"%","arms":[{"name":"1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab","n":10,"value":20,"note":"95% CI 2.5 to 55.6; Figures from the ClinicalTrials.gov results section (first posted 2026-06-25), not from a publication"},{"name":"1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab","n":10,"value":30,"note":"95% CI 6.7 to 65.2"},{"name":"1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab","n":10,"value":30,"note":"95% CI 6.7 to 65.2"}],"source":"https://clinicaltrials.gov/study/NCT07217184?tab=results"}]},{"id":"nct07084896","kind":"trial","name":"Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat in Participants With RRMM","aka":[],"tldr":"A phase 1/2 trial of Belantamab mafodotin, Nirogacestat in multiple myeloma, run by GlaxoSmithKline, active and no longer recruiting.","summary":"Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat in Participants With RRMM is a phase 1/2 interventional study registered as NCT07084896 by GlaxoSmithKline, with 106 participants enrolled, started 2020-06-08 and due to reach its primary completion in 2025-04-17. Interventions recorded: Belantamab mafodotin, Nirogacestat. Conditions listed: Multiple Myeloma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07084896","url":"https://clinicaltrials.gov/study/NCT07084896"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["adc","gamma-secretase-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["belantamab-mafodotin","nirogacestat"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07084896","phase":"1/2","setting":"A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5 - Sub-study 3 - Belantamab Mafodotin and Nirogacestat in Combination","sponsor":"GlaxoSmithKline","started":"2020-06-08","startedType":"actual","yearReported":2026,"enrolled":106,"enrolledBasis":"registry","outcomes":[{"endpoint":"CE Phase: Overall Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat","n":34,"value":29,"note":"95% CI 15.1 to 47.5; Figures from the ClinicalTrials.gov results section (first posted 2026-05-06), not from a publication"},{"name":"CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W","n":37,"value":38,"note":"95% CI 22.5 to 55.2"}],"source":"https://clinicaltrials.gov/study/NCT07084896?tab=results"},{"endpoint":"CE Phase: Progression-free Survival (PFS)","unit":"months","arms":[{"name":"CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat","n":34,"value":3.5,"note":"95% CI 1.4 to 8.6; Figures from the ClinicalTrials.gov results section (first posted 2026-05-06), not from a publication"},{"name":"CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W","n":37,"value":9.6,"note":"95% CI 4.2 to 20.2"}],"source":"https://clinicaltrials.gov/study/NCT07084896?tab=results"}]},{"id":"nct07150091","kind":"trial","name":"Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM","aka":[],"tldr":"A phase 1/2 trial of Belantamab mafodotin, Nirogacestat, Lenalidomide in multiple myeloma, run by GlaxoSmithKline, active and no longer recruiting.","summary":"Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM is a phase 1/2 interventional study registered as NCT07150091 by GlaxoSmithKline, with 20 participants enrolled, started 2022-07-19 and due to reach its primary completion in 2025-04-17. Interventions recorded: Belantamab mafodotin, Nirogacestat, Lenalidomide, Dexamethasone. Conditions listed: Multiple Myeloma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07150091","url":"https://clinicaltrials.gov/study/NCT07150091"}],"tags":["ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["adc","antiemetic-therapy","gamma-secretase-inhibitors","kinase-inhibitors","protac-degrader"],"targets":[],"drugs":["belantamab-mafodotin","nirogacestat","lenalidomide","dexamethasone"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07150091","phase":"1/2","setting":"A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5 - Sub-study 6 - Belantamab Mafodotin, Nirogacestat, Lenalidomide, and Dexamethasone in Combination","sponsor":"GlaxoSmithKline","started":"2022-07-19","startedType":"actual","yearReported":2026,"enrolled":20,"enrolledBasis":"registry","outcomes":[{"endpoint":"DE Phase: Number of Participants With Dose Limiting Toxicities (DLTs)","primary":true,"unit":"participants","arms":[{"name":"0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone","n":5,"value":1,"note":"Figures from the ClinicalTrials.gov results section (first posted 2026-06-16), not from a publication"},{"name":"1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone","n":5,"value":2}],"source":"https://clinicaltrials.gov/study/NCT07150091?tab=results"},{"endpoint":"DE Phase: Overall Response Rate (ORR)","unit":"%","arms":[{"name":"0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone","n":10,"value":40,"note":"95% CI 12.2 to 73.8; Figures from the ClinicalTrials.gov results section (first posted 2026-06-16), not from a publication"},{"name":"1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone","n":10,"value":70,"note":"95% CI 34.8 to 93.3"}],"source":"https://clinicaltrials.gov/study/NCT07150091?tab=results"}]},{"id":"nct06031181","kind":"trial","name":"Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Fudan University, now recruiting.","summary":"Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019) is a phase 3, interventional study registered as NCT06031181 by Fudan University, with a registry enrolment figure of 390 participants, started 2023-03-31 and due to reach its primary completion in 2026-01-01. Interventions recorded: Sublobar Resection. Conditions listed: Lung Adenocarcinoma; Frozen Section; Sublobar Resection. Primary outcome: 5-year recurrence-free survival. Lung eligibility wording from the registry: \"Not receiving lung cancer surgery before;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06031181","url":"https://clinicaltrials.gov/study/NCT06031181"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06031181","phase":"3","setting":"Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section: a Single-arm, Multi-center, Phase III Trial","sponsor":"Fudan University","started":"2023-03-31","startedType":"actual","enrolled":390,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06353386","kind":"trial","name":"Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)","aka":[],"tldr":"A phase 1/2 trial of Opevesostat, Olaparib, Docetaxel, Cabazitaxel, Dexamethasone and Prednisone in prostate cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A) is a phase 1/2 interventional study registered as NCT06353386 by Merck Sharp & Dohme LLC, with 220 participants planned, started 2024-05-20 and due to reach its primary completion in 2029-01-15. Interventions recorded: Opevesostat, Olaparib, Docetaxel, Cabazitaxel, Fludrocortisone acetate and Dexamethasone.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06353386","url":"https://clinicaltrials.gov/study/NCT06353386"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["opevesostat","olaparib","docetaxel","cabazitaxel","dexamethasone","prednisone"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06353386","phase":"1/2","setting":"MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)","sponsor":"Merck Sharp & Dohme LLC","started":"2024-05-20","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06395103","kind":"trial","name":"Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)","aka":["LIGHTBEAM-U01"],"tldr":"A phase 1/2 trial of Zilovertamab vedotin in diffuse large b-cell lymphoma and burkitt lymphoma, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01) is a phase 1/2 interventional study registered as NCT06395103 by Merck Sharp & Dohme LLC, with 90 participants planned, started 2024-08-16 and due to reach its primary completion in 2029-03-31. Interventions recorded: Zilovertamab vedotin. Conditions listed: B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma, Burkitt Lymphoma, Neuroblastoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06395103","url":"https://clinicaltrials.gov/study/NCT06395103"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl","burkitt-lymphoma","ewing-sarcoma"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["zilovertamab-vedotin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06395103","phase":"1/2","setting":"LIGHTBEAM-U01 Substudy 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors","sponsor":"Merck Sharp & Dohme LLC","started":"2024-08-16","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06780098","kind":"trial","name":"Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)","aka":["KEYMAKER-U01I"],"tldr":"A phase 2 trial of Docetaxel in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I) is a phase 2 interventional study registered as NCT06780098 by Merck Sharp & Dohme LLC, with 144 participants planned, started 2025-05-28 and due to reach its primary completion in 2032-03-02. Interventions recorded: R-DXD, I-DXD, Docetaxel, Rescue Medications and Rescue Medication.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06780098","url":"https://clinicaltrials.gov/study/NCT06780098"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06780098","phase":"2","setting":"KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC)","sponsor":"Merck Sharp & Dohme LLC","started":"2025-05-28","startedType":"actual","enrolled":144,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04626479","kind":"trial","name":"Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab, Favezelimab, Belzutifan and Lenvatinib in renal cell carcinoma, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) is a phase 1/2 interventional study registered as NCT04626479 by Merck Sharp & Dohme LLC, with 400 participants enrolled, started 2020-12-16 and due to reach its primary completion in 2026-08-21. Interventions recorded: Pembrolizumab, Favezelimab/Pembrolizumab, Belzutifan, Lenvatinib, Pembrolizumab/Quavonlimab and Vibostolimab/Pembrolizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04626479","url":"https://clinicaltrials.gov/study/NCT04626479"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","favezelimab","belzutifan","lenvatinib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04626479","phase":"1/2","setting":"A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03A in First Line Metastatic Participants","sponsor":"Merck Sharp & Dohme LLC","started":"2020-12-16","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04626518","kind":"trial","name":"Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)","aka":["KEYMAKER-U03"],"tldr":"A phase 1/2 trial of Pembrolizumab, Belzutifan, Lenvatinib and Favezelimab in renal cell carcinoma, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03) is a phase 1/2 interventional study registered as NCT04626518 by Merck Sharp & Dohme LLC, with 370 participants enrolled, started 2020-12-17 and due to reach its primary completion in 2026-08-21. Interventions recorded: Pembrolizumab, MK-4830, Belzutifan, Lenvatinib, Pembrolizumab/Quavonlimab and Favezelimab/Pembrolizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04626518","url":"https://clinicaltrials.gov/study/NCT04626518"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","belzutifan","lenvatinib","favezelimab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04626518","phase":"1/2","setting":"A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03B in Second-Line Metastatic Participants","sponsor":"Merck Sharp & Dohme LLC","started":"2020-12-17","startedType":"actual","enrolled":370,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07049926","kind":"trial","name":"Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (","aka":["KEYMAKER-U03"],"tldr":"A phase 1/2 trial of Belzutifan, Zanzalintinib in renal cell carcinoma, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03) is a phase 1/2 interventional study registered as NCT07049926 by Merck Sharp & Dohme LLC, with 140 participants planned, started 2025-07-20 and due to reach its primary completion in 2031-10-26. Interventions recorded: Belzutifan, Zanzalintinib. Conditions listed: Renal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07049926","url":"https://clinicaltrials.gov/study/NCT07049926"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["belzutifan","zanzalintinib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07049926","phase":"1/2","setting":"A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03C in Participants With Recurrent Disease During or After Anti-PD-(L)1 Adjuvant Therapy","sponsor":"Merck Sharp & Dohme LLC","started":"2025-07-20","startedType":"actual","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06469944","kind":"trial","name":"Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)","aka":["KEYMAKER-U06"],"tldr":"A phase 1/2 trial of Pembrolizumab, Sacituzumab tirumotecan, Capecitabine, Fluorouracil (5-FU), Oxaliplatin and Patritumab deruxtecan in gastric & gastro-oesophageal junction cancer and oesophageal cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06) is a phase 1/2 interventional study registered as NCT06469944 by Merck Sharp & Dohme LLC, with 160 participants planned, started 2024-09-20 and due to reach its primary completion in 2029-09-12. Interventions recorded: Pembrolizumab, Sacituzumab Tirumotecan (sac-TMT), Capecitabine, Leucovorin, Levoleucovorin and 5-Fluorouracil (5-FU).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06469944","url":"https://clinicaltrials.gov/study/NCT06469944"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","esophageal","oesophageal-adenocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","sacituzumab-tirumotecan","capecitabine","fluorouracil","oxaliplatin","patritumab-deruxtecan"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06469944","phase":"1/2","setting":"A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C","sponsor":"Merck Sharp & Dohme LLC","started":"2024-09-20","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06445972","kind":"trial","name":"Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)","aka":[],"tldr":"A phase 1/2 trial of Ramucirumab and Sacituzumab tirumotecan in gastric & gastro-oesophageal junction cancer and oesophageal cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06) is a phase 1/2 interventional study registered as NCT06445972 by Merck Sharp & Dohme LLC, with 210 participants planned, started 2024-08-07 and due to reach its primary completion in 2028-05-09. Interventions recorded: Ramucirumab, Paclitaxel, Sacituzumab Tirumotecan, Rescue Medications and HER3-DXd.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06445972","url":"https://clinicaltrials.gov/study/NCT06445972"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","esophageal","oesophageal-adenocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["ramucirumab","sacituzumab-tirumotecan"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06445972","phase":"1/2","setting":"A Phase 1/2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of Investigational Agents in Combination With Standard of Care Treatments as the Second-Line Treatment of Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma: Substudy 06D","sponsor":"Merck Sharp & Dohme LLC","started":"2024-08-07","startedType":"actual","enrolled":210,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06780111","kind":"trial","name":"Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)","aka":["KEYMAKER-U06"],"tldr":"A phase 1/2 trial of Pembrolizumab, Fluorouracil (5-FU), Oxaliplatin and Sacituzumab tirumotecan in oesophageal cancer, run by Merck Sharp & Dohme LLC, now recruiting.","summary":"Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06) is a phase 1/2 interventional study registered as NCT06780111 by Merck Sharp & Dohme LLC, with 298 participants planned, started 2025-07-30 and due to reach its primary completion in 2032-01-04. Interventions recorded: Pembrolizumab, I-DXd, Leucovorin, Levoleucovorin, 5-Fluorouracil (5-FU) and Oxaliplatin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06780111","url":"https://clinicaltrials.gov/study/NCT06780111"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","fluorouracil","oxaliplatin","sacituzumab-tirumotecan"],"companies":["merck","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06780111","phase":"1/2","setting":"A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E","sponsor":"Merck Sharp & Dohme LLC","started":"2025-07-30","startedType":"actual","enrolled":298,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05623267","kind":"trial","name":"Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT","aka":["SURPASS"],"tldr":"A phase 2/3 trial of sugemalimab in lung cancer, run by Sun Yat-sen University, now recruiting.","summary":"Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT is a phase 2/3, randomised interventional study registered as NCT05623267 by Sun Yat-sen University, with a registry enrolment figure of 346 participants, started 2023-07-01 and due to reach its primary completion in 2025-12-31. Interventions recorded: Sugemalimab; Placebo. Conditions listed: Limited Stage Small Cell Lung Cancer. Primary outcome: Progress Free Survival(PFS). Lung eligibility wording from the registry: \"2、Histologically or cytologically confirmed small cell lung cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05623267","url":"https://clinicaltrials.gov/study/NCT05623267"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["limited-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["sugemalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05623267","phase":"2/3","setting":"A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study of Sugemalimab as Consolidation Therapy in Patients With Limited-stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent or Sequential Chemoradiotherapy","sponsor":"Sun Yat-sen University","started":"2023-07-01","startedType":"actual","enrolled":346,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06134388","kind":"trial","name":"Sulfasalazine in Patients With Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by Tanta University, now recruiting.","summary":"Sulfasalazine in Patients With Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT06134388 by Tanta University, with a registry enrolment figure of 50 participants, started 2023-09-01 and due to reach its primary completion in 2025-09. Interventions recorded: Sulfasalazine. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Evaluating the change in the serum level of Ferritin; Evaluating the change in the serum level of Superoxide dismutase (SOD); Evaluating the change in the serum level of Nuclear factor-kappa B (NF-kB). Colorectal eligibility wording from the registry: \"Histologically confirmed diagnosis of stage IV (metastatic) colorectal cancer\". Sites: Egypt. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06134388","url":"https://clinicaltrials.gov/study/NCT06134388"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06134388","phase":"3","setting":"Clinical Study Evaluating the Efficacy and Safety of Sulfasalazine in Patients With Metastatic Colorectal Cancer","sponsor":"Tanta University","started":"2023-09-01","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"summit-lung","kind":"trial","name":"SUMMIT (lung health check study)","aka":["SUMMIT study","NCT03934866"],"tldr":"The biggest single UK lung screening cohort, run across diverse and deprived London boroughs, which showed the same early-stage shift and also showed that the poorest were the least likely to come.","summary":"SUMMIT screened 2,333,488 primary care records across 251 practices, found 95,297 people eligible for invitation and recruited 12,773 into the lung health check arm. Of these, 261 (2.0 percent) were diagnosed with lung cancer, 207 of them (79.3 percent) at stage 1 or 2. Surgery was the primary treatment for 201 people; 28 of 241 resections (11.6 percent) turned out to be benign, and one person (0.4 percent) died within 90 days of surgery. At 12 months, episode sensitivity was 97.0 percent and specificity 95.2 percent, giving a false-positive rate of 4.8 percent.\n\nThe uptake paper is the uncomfortable one. Of 29,545 who responded to an invitation, response was significantly higher in the least deprived areas than the most (odds ratio 1.89) and higher in former than current smokers (also 1.89). A programme aimed at the people most at risk keeps reaching the people least at risk first, which is the problem that IMPALA and INSIGHT are now trying to solve.","status":"positive","asOf":"2026-09-25","links":[{"label":"Lancet Oncology 2025","url":"https://europepmc.org/article/MED/40154514"},{"label":"Lancet Public Health 2023 (uptake)","url":"https://europepmc.org/article/MED/36709053"},{"label":"NIHR Be Part of Research","url":"https://bepartofresearch.nihr.ac.uk/results/search-results?query=SUMMIT%20lung%20health%20check"}],"tags":["uk","screening","lung"],"related":[],"cancers":["nsclc","lung-cancer"],"sections":["early-detection"],"technologies":["low-dose-ct-screening"],"targets":[],"drugs":[],"companies":[],"institutions":["uclh"],"pathways":[],"terms":[],"trials":["ukls","ylst"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03934866","phase":"observational","setting":"A lung health check with low-dose CT offered to high-risk people aged 55 to 77 across 329 primary care practices in north east and north central London, one of the most ethnically diverse populations in Europe","sponsor":"University College London Hospitals NHS Foundation Trust, funded by GRAIL","result":"261 lung cancers in 12,773 participants, 79.3 percent at stage 1 or 2; episode sensitivity 97.0 percent and false-positive rate 4.8 percent; uptake 1.89 times higher in the least deprived areas than the most.","started":"2019-04-08","startedType":"actual","yearReported":2025,"enrolled":12773,"enrolledBasis":"registered","enrolledNote":"12,773 participants were recruited into the lung health check arm between 8 April 2019 and 14 May 2021; the study's blood-test arm recruited separately.","outcomes":[]},{"id":"sunlight","kind":"trial","name":"SUNLIGHT","aka":[],"tldr":"Adding the old blood-vessel antibody to a late-line chemotherapy pill extended survival by three months in patients who had exhausted standard options.","summary":"SUNLIGHT, trial NCT04737187 sponsored by Taiho and Servier and reported in 2023, showed that adding the old anti-VEGF antibody bevacizumab to the late-line chemotherapy tablet trifluridine and tipiracil extends survival by a few months in refractory metastatic colorectal cancer. It randomised 492 patients and met its primary overall survival endpoint, leading to FDA approval in August 2023 and making the combination the preferred third-line option ahead of regorafenib or fruquintinib in many guidelines. OnCo links it to colorectal cancer, VEGF as a target, trifluridine and tipiracil, bevacizumab and Tae Won Kim, and the result is consistent with the Danish phase 2 trial. Whether the combination should be sequenced before or after fruquintinib, since the two have never been compared, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04737187","url":"https://clinicaltrials.gov/study/NCT04737187"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":["vegf"],"drugs":["trifluridine-tipiracil","bevacizumab"],"companies":["servier"],"institutions":[],"pathways":[],"terms":[],"trials":["recourse","correct","fresco"],"people":["kim-tae-won"],"bottlenecks":[],"keyPapers":["paper-prager-sunlight-trifluridine-tipiracil-bevacizumab-nejm-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04737187","phase":"3","setting":"Refractory metastatic colorectal cancer: trifluridine/tipiracil + bevacizumab vs trifluridine/tipiracil","sponsor":"Taiho / Servier","result":"OS 10.8 vs 7.5 months, HR 0.61.","started":"2020-11-25","startedType":"actual","yearReported":2023,"enrolled":492,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Trifluridine/tipiracil + bevacizumab","n":246,"value":10.8},{"name":"Trifluridine/tipiracil","n":246,"value":7.5}],"hr":0.61,"ci":[0.49,0.77],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2214963"}],"replication":"Consistent with the Danish phase 2 (Pfeiffer, Lancet Oncology 2020)."},{"id":"sunmo","kind":"trial","name":"SUNMO","aka":[],"tldr":"A chemotherapy-free bispecific plus ADC doublet beat salvage chemotherapy in relapsed large B-cell lymphoma.","summary":"SUNMO, trial NCT05171647 sponsored by Roche and reported in 2025, showed that a chemotherapy-free doublet of the CD20 bispecific mosunetuzumab and the CD79b antibody-drug conjugate polatuzumab vedotin beats rituximab-gemcitabine-oxaliplatin salvage chemotherapy in relapsed or refractory large B-cell lymphoma in transplant-ineligible patients. It randomised 208 patients and met its dual primary endpoints of progression-free survival and overall response, with a much higher complete response rate, in a fixed-duration outpatient regimen. OnCo links it to lymphoma, mosunetuzumab, polatuzumab vedotin and the pairing of a CD20 bispecific with a CD79b ADC. Overall survival is not yet mature, and whether the doublet is an alternative for patients not fit for CAR-T or a competitor to it is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05171647","url":"https://clinicaltrials.gov/study/NCT05171647"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["mosunetuzumab","polatuzumab-vedotin"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05171647","phase":"3","setting":"R/R LBCL, transplant-ineligible: mosunetuzumab + polatuzumab vs R-GemOx","sponsor":"Roche","result":"PFS improved (HR reported 2025).","started":"2022-04-25","startedType":"actual","yearReported":2025,"enrolled":208,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (dual primary)","primary":true,"unit":"months","arms":[{"name":"Mosunetuzumab + polatuzumab vedotin","n":138,"value":11.5},{"name":"R-GemOx","n":70,"value":3.8}],"hr":0.41,"ci":[0.3,0.6],"p":"<0.0001","source":"https://ascopubs.org/doi/10.1200/JCO-25-01957"},{"endpoint":"Overall response rate (dual primary)","primary":true,"unit":"%","arms":[{"name":"Mosunetuzumab + polatuzumab vedotin","value":70},{"name":"R-GemOx","value":40}],"p":"<0.0001","source":"https://ascopubs.org/doi/10.1200/JCO-25-01957"},{"endpoint":"Complete response rate","unit":"%","arms":[{"name":"Mosunetuzumab + polatuzumab vedotin","value":51},{"name":"R-GemOx","value":24}],"source":"https://ascopubs.org/doi/10.1200/JCO-25-01957"}],"replication":"Consistent with STARGLO (glofitamab + GemOx vs R-GemOx, OS benefit) for CD20xCD3 bispecific-based regimens in transplant-ineligible R/R LBCL; OS was a key secondary endpoint and is not yet mature."},{"id":"sunrise-1","kind":"trial","name":"SunRISe-1","aka":[],"tldr":"A tiny pretzel-shaped device that slowly releases chemotherapy inside the bladder cleared carcinoma in situ in over 80% of patients whose BCG had failed.","summary":"Cohort 2 (TAR-200 alone): confirmed CR 82%; 51% remained in CR at 1 year; 98% of responses within 12 weeks. FDA approval of Inlexzo (gemcitabine intravesical system) on 9 September 2025 for BCG-unresponsive NMIBC with CIS. Cetrelimab added little. Phase 3 SunRISe-3 (BCG-naive) and SunRISe-4 (MIBC) ongoing.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04640623","url":"https://clinicaltrials.gov/study/NCT04640623"},{"label":"FDA approval of Inlexzo","url":"https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated"}],"tags":[],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["bcg-and-intravesical-therapy"],"targets":[],"drugs":["tar-200"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["bcg-unresponsive"],"trials":[],"people":["andrea-necchi"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04640623","phase":"2","setting":"BCG-unresponsive high-risk NMIBC with carcinoma in situ: TAR-200 (gemcitabine intravesical system) ± cetrelimab, single-arm cohorts","sponsor":"Johnson & Johnson","result":"CR 82%; 51% in CR at 12 months.","started":"2020-12-18","startedType":"actual","yearReported":2024,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response rate (CIS)","primary":true,"unit":"%","arms":[{"name":"TAR-200 monotherapy","n":85,"value":82}]},{"endpoint":"Duration of CR ≥12 months","unit":"%","arms":[{"name":"TAR-200 monotherapy","value":51}]}],"replication":"Single-arm registrational cohort; randomised confirmation in SunRISe-3 pending."},{"id":"nct05712902","kind":"trial","name":"Sunvozertinib (DZD9008) in Pretreated Lung Cancer Patients with EGFR Exon20 Insertion Mutation (WU-KONG6)","aka":["WU-KONG6"],"tldr":"A phase 2 trial of Sunvozertinib in non-small-cell lung cancer and small-cell lung cancer, run by Dizal Pharmaceuticals, active and no longer recruiting.","summary":"Sunvozertinib (DZD9008) in Pretreated Lung Cancer Patients with EGFR Exon20 Insertion Mutation (WU-KONG6) is a phase 2 interventional study registered as NCT05712902 by Dizal Pharmaceuticals, with 104 participants enrolled, started 2021-07-19 and due to reach its primary completion in 2022-10-17. Interventions recorded: Sunvozertinib. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05712902","url":"https://clinicaltrials.gov/study/NCT05712902"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["sunvozertinib"],"companies":["dizal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05712902-lancet-respir-med-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05712902","phase":"2","setting":"A Phase II, Single Arm, Multicenter Study to Evaluate Anti-tumor Activity, Safety, Tolerability and Pharmacokinetics of DZD9008 in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with EGFR Exon 20 Insertion Mutation","sponsor":"Dizal Pharmaceuticals","started":"2021-07-19","startedType":"actual","enrolled":104,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06643884","kind":"trial","name":"Suprachoroidal Administration in Subjects With Metastases to the Choroid","aka":[],"tldr":"A phase 2 trial of AU-011 in advanced solid tumours, run by Aura Biosciences, now recruiting.","summary":"Suprachoroidal Administration in Subjects With Metastases to the Choroid is a phase 2 interventional study registered as NCT06643884 by Aura Biosciences, with 24 participants planned, started 2024-12-16 and due to reach its primary completion in 2026-11-30. Interventions recorded: AU-011, SCS Microinjector and Laser.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06643884","url":"https://clinicaltrials.gov/study/NCT06643884"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["aura-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06643884","phase":"2","setting":"A Phase 2, Open-Label, Dose Escalation Trial Assessing the Safety, Tolerability, and Treatment Effect of Belzupacap Sarotalocan (AU-011) With Suprachoroidal Administration in Subjects With Metastases to the Choroid","sponsor":"Aura Biosciences","started":"2024-12-16","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06743126","kind":"trial","name":"SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma","aka":["SUPRAME"],"tldr":"A phase 3 trial testing IMA203 in melanoma, now recruiting.","summary":"SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma is a phase 3 interventional study registered as NCT06743126, led by Immatics US, and recruiting on the registry. Official title: A Prospective, Multicenter, Open-label, Randomised, Actively Controlled, Parallel-group Phase 3 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of IMA203 Versus Investigator's Choice of Treatment in Patients With Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (ACTengine® IMA203-301). Planned enrolment is 360 participants (estimated). The study started in 2025-01-14 and primary completion is expected in 2028-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06743126","url":"https://clinicaltrials.gov/study/NCT06743126"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["ima203"],"companies":["immatics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06743126","phase":"3","setting":"A Prospective, Multicenter, Open-label, Randomized, Actively Controlled, Parallel-group Phase 3 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of IMA203 Versus Investigator's Choice of Treatment in Patients With Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (ACTengine® IMA203-301)","sponsor":"Immatics US","started":"2025-01-14","startedType":"actual","enrolled":360,"enrolledBasis":"registry","outcomes":[]},{"id":"supremo","kind":"trial","name":"SUPREMO (BIG 2-04)","aka":["SUPREMO trial","BIG 2-04","Selective Use of Postoperative Radiotherapy aftEr MastectOmy"],"tldr":"For women with one to three involved nodes or a larger node-negative tumour, radiotherapy to the chest wall after mastectomy did not help them live longer. It roughly halved the small chance of the cancer returning on the chest wall, from one in forty to one in ninety.","summary":"SUPREMO is the trial the postmastectomy radiotherapy question needed, because the meta-analysis that established the practice pooled trials run between 1964 and 1986, before modern systemic therapy. It randomised patients with intermediate-risk disease after mastectomy, an axillary procedure and systemic therapy to chest-wall irradiation of 40 to 50 Gy or to none; the intention-to-treat population was 1,607.\n\nAt a median 9.6 years, ten-year overall survival was 81.4 percent with irradiation and 81.9 percent without (hazard ratio for death 1.04, 95 percent confidence interval 0.82 to 1.30, p=0.80). Twenty-nine patients had a chest-wall recurrence, nine (1.1 percent) with irradiation and twenty (2.5 percent) without, a hazard ratio of 0.45 (0.20 to 0.99). Disease-free survival was 76.2 against 75.5 percent (hazard ratio 0.97, 0.79 to 1.18) and distant metastasis-free survival 78.2 against 79.2 percent (1.06, 0.86 to 1.31).\n\nThe limits are worth stating because they are being argued over. SUPREMO tested chest-wall irradiation alone, not comprehensive regional nodal irradiation including the internal mammary chain, so it does not speak to the nodal question that MA.20 and EORTC 22922 answered. Its sample size was cut and its eligibility widened during a long accrual, and the population skews to the lower end of intermediate risk. Commentators have made both cases from the same paper: that postmastectomy radiotherapy can be safely omitted in this group, and that the trial does not resemble the way radiotherapy is now delivered.\n\nIn England, NICE NG101 recommendation 1.13.10 offers postmastectomy radiotherapy for node-positive macrometastatic disease or involved margins and 1.13.12 says not to offer it to people at low risk of local recurrence; the guideline predates this trial.","status":"negative","asOf":"2026-09-25","links":[{"label":"ISRCTN61145589","url":"https://www.isrctn.com/ISRCTN61145589"},{"label":"SUPREMO ten-year survival (New England Journal of Medicine 2025)","url":"https://doi.org/10.1056/NEJMoa2412225"},{"label":"Reconsidering postmastectomy radiotherapy after SUPREMO (Radiotherapy and Oncology 2026)","url":"https://doi.org/10.1016/j.radonc.2026.111416"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["imrt-igrt","hypofractionated-radiotherapy"],"targets":[],"drugs":[],"companies":["big"],"institutions":[],"pathways":[],"terms":["post-mastectomy-radiotherapy","mastectomy","breast-reconstruction"],"trials":["nsabp-b51","ma-20","eortc-22922"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN61145589","phase":"3","setting":"Intermediate-risk breast cancer after mastectomy, an axillary procedure and systemic therapy, defined as pT1N1, pT2N1, pT3N0, or pT2N0 with grade 3 histology or lymphovascular invasion: chest-wall irradiation of 40 to 50 Gy against no chest-wall irradiation, with overall survival at ten years as the primary endpoint","sponsor":"University of Edinburgh and the Medical Research Council, within the Breast International Group","result":"Ten-year overall survival 81.4 percent with chest-wall irradiation against 81.9 percent without (hazard ratio 1.04, p=0.80); chest-wall recurrence 1.1 against 2.5 percent (hazard ratio 0.45).","yearReported":2025,"enrolled":1607,"enrolledBasis":"randomised","enrolledNote":"The intention-to-treat population was 1,607 patients, 808 assigned to irradiation and 799 to none; the trial is registered as ISRCTN61145589 and has no ClinicalTrials.gov record.","outcomes":[{"endpoint":"Overall survival at 10 years","primary":true,"unit":"%","arms":[{"name":"Chest-wall irradiation","n":808,"value":81.4},{"name":"No chest-wall irradiation","n":799,"value":81.9}],"hr":1.04,"ci":[0.82,1.3],"p":"0.80","source":"https://doi.org/10.1056/NEJMoa2412225"},{"endpoint":"Chest-wall recurrence","unit":"%","arms":[{"name":"Chest-wall irradiation","n":808,"value":1.1,"note":"nine patients"},{"name":"No chest-wall irradiation","n":799,"value":2.5,"note":"twenty patients"}],"hr":0.45,"ci":[0.2,0.99],"source":"https://doi.org/10.1056/NEJMoa2412225"},{"endpoint":"Disease-free survival at 10 years","unit":"%","arms":[{"name":"Chest-wall irradiation","n":808,"value":76.2},{"name":"No chest-wall irradiation","n":799,"value":75.5}],"hr":0.97,"ci":[0.79,1.18],"source":"https://doi.org/10.1056/NEJMoa2412225"}],"replication":"The EBCTCG overview of 8,135 women in 22 trials run between 1964 and 1986 found postmastectomy radiotherapy reduced breast cancer mortality in women with one to three positive nodes (rate ratio 0.80, 0.67 to 0.95); SUPREMO tested the same question with modern systemic therapy and found no survival gain."},{"id":"avril-surgery-versus-radiotherapy-bcc","kind":"trial","name":"Surgery against radiotherapy for basal cell carcinoma of the face","aka":["Avril trial","Institut Gustave Roussy basal cell carcinoma trial"],"tldr":"The only randomised trial ever run of surgery against radiotherapy for the commonest skin cancer found surgery better on both counts: fewer cancers came back and the face looked better afterwards. Radiotherapy is used when an operation is not possible, not because it is equal.","summary":"This is the trial that decides the order of the two curative treatments for basal cell carcinoma, and it has never been repeated. Beginning in 1982, the Institut Gustave Roussy randomised 347 patients with a primary facial basal cell carcinoma of less than 4 cm to surgery or radiotherapy. In the surgery arm 71 per cent had local anaesthesia and 91 per cent had frozen section examination of the margin. The radiotherapy arm reflects French practice of the period: 55 per cent interstitial brachytherapy, 33 per cent contact therapy and 12 per cent conventional external beam.\n\nThe four-year actuarial failure rate, counting persistent as well as recurrent disease, was 0.7 per cent after surgery (95 per cent confidence interval 0.1 to 3.9) against 7.5 per cent after radiotherapy (4.2 to 13.1), log-rank p=0.003.\n\nThe cosmetic comparison was done carefully, with five judges including three people not involved in the trial rating standardised photographs. Four of the five rated surgery significantly better. Eighty-seven per cent of the surgical patients and 69 per cent of the irradiated patients called the cosmetic result good (p<0.01); by the dermatologist's rating it was 79 against 40 per cent. A later analysis of the same cohort showed why the gap widens: appearance improves in the years after surgery and stays the same or deteriorates after radiotherapy, because radiation changes the skin permanently. The exception was the nose, where the difference still favoured surgery but was not significant.\n\nRadiotherapy remains the right treatment for people in whom an operation would be mutilating or is refused, for those too frail for surgery, and after incomplete excision where re-operation is not possible. This trial is why it is second and not first.","status":"positive","asOf":"2026-09-25","links":[{"label":"Randomised comparison (British Journal of Cancer 1997)","url":"https://doi.org/10.1038/bjc.1997.343"},{"label":"Randomised comparison on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/9218740/"},{"label":"Cosmetic analysis (Plastic and Reconstructive Surgery 2000)","url":"https://doi.org/10.1097/00006534-200006000-00039"}],"tags":[],"related":[],"cancers":["basal-cell-carcinoma","skin-cancer"],"sections":[],"technologies":["brachytherapy","electron-beam-therapy-systems","imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["radiotherapy-for-skin-cancer","surgical-margins-keratinocyte-cancer"],"trials":["mohs-versus-excision-facial-bcc","trog-05-01"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Primary basal cell carcinoma of the face measuring less than 4 cm: surgery, with frozen section examination in 91 per cent, against radiotherapy given as interstitial brachytherapy in 55 per cent, contact therapy in 33 per cent and conventional external beam in 12 per cent, with the failure rate at four years as the primary endpoint and cosmetic result as the secondary endpoint","sponsor":"Institut Gustave Roussy, France","result":"Four-year failure rate 0.7 per cent after surgery against 7.5 per cent after radiotherapy (p=0.003), with a good cosmetic result in 87 against 69 per cent by the patient's judgement and 79 against 40 per cent by the dermatologist's.","yearReported":1997,"enrolled":347,"enrolledBasis":"randomised","enrolledNote":"347 patients were randomised from 1982, 174 to surgery and 173 to radiotherapy; the trial began two decades before trial registration existed and has no registry record.","outcomes":[{"endpoint":"Actuarial failure rate at 4 years","primary":true,"unit":"%","arms":[{"name":"Surgery","n":174,"value":0.7,"note":"95 per cent confidence interval 0.1 to 3.9"},{"name":"Radiotherapy","n":173,"value":7.5,"note":"95 per cent confidence interval 4.2 to 13.1"}],"p":"0.003","source":"https://doi.org/10.1038/bjc.1997.343"},{"endpoint":"Good cosmetic result, patient's assessment at 4 years","unit":"%","arms":[{"name":"Surgery","value":87},{"name":"Radiotherapy","value":69}],"p":"<0.01","source":"https://doi.org/10.1038/bjc.1997.343"},{"endpoint":"Good cosmetic result, dermatologist's assessment at 4 years","unit":"%","arms":[{"name":"Surgery","value":79},{"name":"Radiotherapy","value":40}],"source":"https://doi.org/10.1097/00006534-200006000-00039"}],"replication":"No randomised trial has compared surgery with modern radiotherapy for basal cell carcinoma since. The radiotherapy techniques in this trial, particularly contact therapy, are not the techniques used today, which is the strongest argument against reading the 7.5 per cent as a current figure."},{"id":"nct04288999","kind":"trial","name":"Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer","aka":["JCOG1801","RC-SURVIVE"],"tldr":"A phase 3 trial in colorectal cancer, run by National Cancer Center Hospital East, now recruiting.","summary":"Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer is a phase 3, randomised interventional study registered as NCT04288999 by National Cancer Center Hospital East, with a registry enrolment figure of 110 participants, started 2019-10-01 and due to reach its primary completion in 2025-08. Interventions recorded: Chemotherapy; Preoperative radiotherapy; Procedure. Conditions listed: Rectal Cancer Recurrent. Primary outcome: Locally recurrent free survival. Colorectal eligibility wording from the registry: \"Histopathologically proven adenocarcinoma or adenosquamous carcinoma on the resected specimen of the initial rectal cancer or endoscopic biopsy from the initial rectal cancer\". Sites: Japan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04288999","url":"https://clinicaltrials.gov/study/NCT04288999"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04288999","phase":"3","setting":"JCOG1801: A Phase III Randomized Controlled Trial Comparing Surgery Plus Adjuvant Chemotherapy With Preoperative Chemoradiotherapy Followed by Surgery Plus Adjuvant Chemotherapy for Locally Recurrent Rectal Cancer (RC-SURVIVE Study)","sponsor":"National Cancer Center Hospital East","started":"2019-10-01","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00003788","kind":"trial","name":"Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas","aka":[],"tldr":"A phase 3 trial of Carmustine, Lomustine, Porfimer sodium and Procarbazine in Brain and spinal cord tumours, run by Colorado Health Foundation, with a status the registry has not verified recently.","summary":"Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas is a phase 3 interventional study registered as NCT00003788 by Colorado Health Foundation, with 270 participants planned, started 1998-04. Interventions recorded: carmustine, lomustine, porfimer sodium, procarbazine hydrochloride, neoadjuvant therapy, surgical procedure, radiation therapy. Conditions recorded: Brain and Central Nervous System Tumors.\n\nLinked to the drug Porfimer sodium because the registry names it among its interventions and Brain and spinal cord tumours among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00003788","url":"https://clinicaltrials.gov/study/NCT00003788"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["brain-tumours","glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":["carmustine","lomustine","porfimer-sodium","procarbazine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003788","phase":"3","setting":"Prospective Clinical Trials in the Use of Photodynamic Therapy (PDT) for the Treatment of Malignant Supratentorial Brain Tumors","sponsor":"Colorado Health Foundation","started":"1998-04","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06526793","kind":"trial","name":"Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL","aka":["SOUNDTRACK-B"],"tldr":"A phase 2 trial of AZD0486 in hodgkin lymphoma and non-hodgkin lymphoma, run by AstraZeneca, now recruiting.","summary":"Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL is a phase 2 interventional study registered as NCT06526793 by AstraZeneca, with 270 participants planned, started 2024-11-27 and due to reach its primary completion in 2028-04-21. Interventions recorded: Surovatamig. Conditions listed: B-cell Non-Hodgkin Lymphoma, Follicular Lymphoma (FL), Large B-Cell Lymphoma (LBCL). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06526793","url":"https://clinicaltrials.gov/study/NCT06526793"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma","follicular-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["azd0486"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06526793","phase":"2","setting":"A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Surovatamig (AZD0486) in Participants With Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)","sponsor":"AstraZeneca","started":"2024-11-27","startedType":"actual","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07509151","kind":"trial","name":"Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin He","aka":["SOUNDTRACK-C1"],"tldr":"A phase 3 trial of AZD0486 in chronic lymphocytic leukaemia, run by AstraZeneca, now recruiting.","summary":"Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV) is a phase 3 interventional study registered as NCT07509151 by AstraZeneca, with 420 participants planned, started 2026-05-05 and due to reach its primary completion in 2031-08-29. Interventions recorded: Surovatamig. Conditions listed: Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07509151","url":"https://clinicaltrials.gov/study/NCT07509151"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":[],"targets":[],"drugs":["azd0486"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07509151","phase":"3","setting":"A Phase III, Randomised, Open-label, Multicentre, Study of Surovatamig as Consolidation Therapy Versus Observation After First-line Induction Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV (SOUNDTRACK-C1)","sponsor":"AstraZeneca","started":"2026-05-05","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05988372","kind":"trial","name":"Surufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer (SAGE)","aka":["SAGE"],"tldr":"A phase 2 trial of surufatinib, serplulimab and gemcitabine in pancreatic cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"Surufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer (SAGE) is a phase 2, randomised interventional study registered as NCT05988372 by Sun Yat-sen University, with a registry enrolment figure of 50 participants, started 2023-10-23 and due to reach its primary completion in 2023-10-23. Interventions recorded: Surufatinib + Serplulimab+Albumin-paclitaxel + Gemcitabine; Albumin-paclitaxel + Gemcitabine. Conditions listed: Locally Advanced Pancreatic Cancer. Primary outcome: R0 Surgical Resection Rate. Pancreatic eligibility wording from the registry: \"Pathologically confirmed unresectable locally advanced pancreatic cancer, received no surgical therapy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05988372","url":"https://clinicaltrials.gov/study/NCT05988372"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["surufatinib","serplulimab","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05988372","phase":"2","setting":"Surufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer : a Phase II Randomized Controlled PILOT Study (SAGE)","sponsor":"Sun Yat-sen University","started":"2023-10-23","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06361030","kind":"trial","name":"Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, not yet recruiting.","summary":"Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT06361030 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 40 participants, started 2024-06-01 and due to reach its primary completion in 2026-06-01. Interventions recorded: surufatinib combined with gemcitabine plus nab-paclitaxel. Conditions listed: Pancreatic Cancer; Pancreatic Cancer Non-resectable; Pancreatic Ductal Adenocarcinoma, PDAC. Primary outcome: Surgical conversion rate. Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed adenocarcinoma of the pancreas\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06361030","url":"https://clinicaltrials.gov/study/NCT06361030"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06361030","phase":"2","setting":"An Exploratory Clinical Study of Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Patients With Locally Advanced Pancreatic Cancer","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2024-06-01","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06531291","kind":"trial","name":"Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation","aka":[],"tldr":"A phase 2 trial of serplulimab and surufatinib in gallbladder cancer and other biliary tract cancers, run by RenJi Hospital, not yet recruiting.","summary":"Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation is a phase 2 interventional study registered as NCT06531291 by RenJi Hospital, with a registry enrolment figure of 80 participants, started 2024-08-10 and due to reach its primary completion in 2027-08-09. Interventions recorded: Surufatinib, Serplulimab, standard chemotherapy. Conditions listed: ESCC, Biliary Tract Cancer, Gastric Cancer, Pancreas Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06531291","url":"https://clinicaltrials.gov/study/NCT06531291"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["serplulimab","surufatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06531291","phase":"2","setting":"Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation: A Single-arm, Multi-cohort, Open-label, Single-center, Prospective, Exploratory Clinical Study","sponsor":"RenJi Hospital","started":"2024-08-10","startedType":"estimated","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07833241","kind":"trial","name":"Surufatinib in Combination With Iparomlimab and Tuvonralimab Injection and AG Chemotherapy for Neoadjuvant Therapy of HRPC or BRPC","aka":["ZSPAC-22"],"tldr":"A phase 2 trial of gemcitabine + nab-paclitaxel, gemcitabine, capecitabine and fOLFIRINOX / mFOLFIRINOX in pancreatic cancer, run by Shanghai Zhongshan Hospital, not yet recruiting.","summary":"Surufatinib in Combination With Iparomlimab and Tuvonralimab Injection and AG Chemotherapy for Neoadjuvant Therapy of HRPC or BRPC is a phase 2, interventional study registered as NCT07833241 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 56 participants, started 2026-09-01 and due to reach its primary completion in 2028-09-01. Interventions recorded: Surufatinib Plus Iparomlimab and Tuvonralimab and AG Chemotherapy; Gemcitabine plus Capecitabine; Modified FOLFIRINOX. Conditions listed: Borderline Resectable Pancreatic Cancer; High-Risk Resectable Pancreatic Cancer. Primary outcome: 12-month Event Free Survival (EFS) rate. Pancreatic eligibility wording from the registry: \"* Patients with high-risk resectable or borderline resectable pancreatic adenocarcinoma confirmed by histopathology or cytology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07833241","url":"https://clinicaltrials.gov/study/NCT07833241"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel","gemcitabine","capecitabine","folfirinox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07833241","phase":"2","setting":"Neoadjuvant Surufatinib in Combination With Iparomlimab and Tuvonralimab Injection and AG Chemotherapy for High-risk Resectable or Borderline Resectable Pancreatic Cancer: a Single-arm, Single-center, Exploratory Clinical Study","sponsor":"Shanghai Zhongshan Hospital","started":"2026-09-01","startedType":"estimated","enrolled":56,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05218889","kind":"trial","name":"Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of gemcitabine + nab-paclitaxel in pancreatic cancer, run by Chinese PLA General Hospital, now recruiting.","summary":"Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer is a phase 1/2, randomised interventional study registered as NCT05218889 by Chinese PLA General Hospital, with a registry enrolment figure of 90 participants, started 2021-08-04 and due to reach its primary completion in 2024-12-16. Interventions recorded: surufatinib + camrelizumab + nab-paclitaxel + S-1; nab-paclitaxel + gemcitabine. Conditions listed: Pancreatic Cancer; PDAC - Pancreatic Ductal Adenocarcinoma; Pancreas Cancer; Pancreatic Neoplasms. Primary outcome: DLTs; RP2D; ORR. Pancreatic eligibility wording from the registry: \"Patients with histologically or cytologically confirmed unresectable, locally advanced, or metastatic pancreatic ductal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05218889","url":"https://clinicaltrials.gov/study/NCT05218889"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05218889","phase":"1/2","setting":"Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer: a Prospective, Randomized Controlled Clinical Trial","sponsor":"Chinese PLA General Hospital","started":"2021-08-04","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07436741","kind":"trial","name":"Surufatinib Plus Gemcitabine and Nab-paclitaxel vs. Gemcitabine Plus Nab-paclitaxel in Neoadjuvant Therapy for High - Risk Resectable or Borderline Resectable P","aka":[],"tldr":"A phase 3 trial of gemcitabine + nab-paclitaxel in pancreatic cancer, run by Tianjin Medical University Cancer Institute and Hospital, now recruiting.","summary":"Surufatinib Plus Gemcitabine and Nab-paclitaxel vs. Gemcitabine Plus Nab-paclitaxel in Neoadjuvant Therapy for High - Risk Resectable or Borderline Resectable Pancreatic Cancer is a phase 3, randomised interventional study registered as NCT07436741 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 106 participants, started 2026-03-03 and due to reach its primary completion in 2028-09. Interventions recorded: surufatinib + gemcitabine + nab-paclitaxel; gemcitabine + nab-paclitaxel. Conditions listed: Pancreatic Cancer, Adult. Primary outcome: Surgical complete resection rate (R0). Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed high-risk resectable or borderline resectable pancreatic cancer;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07436741","url":"https://clinicaltrials.gov/study/NCT07436741"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07436741","phase":"3","setting":"A Prospective, Randomized, Controlled, Multi-center Clinical Trial of Surufatinib Combined With Gemcitabine and Nab-paclitaxel Versus Gemcitabine Combined With Nab-paclitaxel in Neoadjuvant Therapy for High - Risk Resectable or Borderline Resectable Pancreatic Cancer","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2026-03-03","startedType":"actual","enrolled":106,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07469956","kind":"trial","name":"Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of surufatinib, toripalimab and fOLFIRINOX / mFOLFIRINOX in pancreatic cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancreatic Cancer is a phase 2, interventional study registered as NCT07469956 by Sun Yat-sen University, with a registry enrolment figure of 30 participants, started 2026-03-31 and due to reach its primary completion in 2028-01-31. Interventions recorded: Surufatinib; Toripalimab; mFOLFIRINOX. Conditions listed: Pancreatic Cancer Resectable. Primary outcome: 12-month Event Free Survival Rate. Pancreatic eligibility wording from the registry: \"Patients with high-risk resectable or borderline resectable pancreatic cancer confirmed by pathological tissue or cytology:\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07469956","url":"https://clinicaltrials.gov/study/NCT07469956"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["surufatinib","toripalimab","folfirinox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07469956","phase":"2","setting":"Neoadjuvant Therapy With Surufatinib Combined With mFOLFIRINOX and Toripalimab for High-risk or Borderline Resectable Pancreatic Cancer: A Phase II, Single-arm, Single-center Study","sponsor":"Sun Yat-sen University","started":"2026-03-31","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06338683","kind":"trial","name":"Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Qinghai Red Cross Hospital, now recruiting.","summary":"Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer is a phase 3, randomised interventional study registered as NCT06338683 by Qinghai Red Cross Hospital, with a registry enrolment figure of 230 participants, started 2024-03-20 and due to reach its primary completion in 2027-03-20. Interventions recorded: Olanzapine 2.5 MG; Standard anti-tumor treatment; Nutritional advice. Conditions listed: Advanced Cancer; Olanzapine; Progression Free Survival. Primary outcome: Comparing the difference in Median PFS between the two groups. Lung eligibility wording from the registry: \"Stage III or IV inoperable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer and lung cancer confirmed by histology or cytology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06338683","url":"https://clinicaltrials.gov/study/NCT06338683"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06338683","phase":"3","setting":"Survival With the Addition of Olanzapine to Anticancer Therapy in Patients With Locally Advanced, Unresectable or Metastatic Gastric, Esophageal, Hepatopancreaticobiliary and Lung Cancer: a Randomized Clinical Trial","sponsor":"Qinghai Red Cross Hospital","started":"2024-03-20","startedType":"actual","enrolled":230,"enrolledBasis":"registry","outcomes":[]},{"id":"swedish-rectal-cancer-trial","kind":"trial","name":"Swedish Rectal Cancer Trial","aka":[],"tldr":"The first trial to show that a week of radiotherapy before rectal cancer surgery both halves local recurrence and lets more people live, in the era before total mesorectal excision.","summary":"The Swedish Rectal Cancer Trial randomised 1,168 patients with resectable rectal cancer to 25 Gy in five fractions before surgery or to surgery alone. Irradiation did not increase postoperative mortality. At five years local recurrence was 11 percent (63 of 553) after radiotherapy against 27 percent (150 of 557) after surgery alone, and overall survival was better in the irradiated group. The control arm's 27 percent local recurrence rate reflects surgery before total mesorectal excision was standardised, which is why the Dutch TME trial repeated the question with quality-controlled surgery and found a smaller absolute gain and no survival difference. The two trials together define what preoperative radiotherapy does: it compensates for imperfect surgery and, once the surgery is good, buys local control rather than life.","status":"positive","asOf":"2026-09-24","links":[{"label":"Swedish Rectal Cancer Trial: improved survival with preoperative radiotherapy in resectable rectal cancer (New England Journal of Medicine 1997)","url":"https://doi.org/10.1056/NEJM199704033361402"}],"tags":[],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["dutch-tme-trial","stockholm-iii"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Resectable rectal cancer: 25 Gy in five fractions of preoperative radiotherapy followed by surgery within a week, against surgery alone","sponsor":"Swedish Rectal Cancer Trial collaborators","result":"Five-year local recurrence 11 against 27 percent, with better overall survival.","yearReported":1997,"enrolled":1168,"enrolledBasis":"randomised","enrolledNote":"1,168 patients were randomised; the trial ran from 1987 to 1990 and predates the registries.","outcomes":[{"endpoint":"Local recurrence at 5 years","primary":true,"unit":"percent","arms":[{"name":"Preoperative 5 x 5 Gy then surgery","n":553,"value":11},{"name":"Surgery alone","n":557,"value":27}],"source":"https://doi.org/10.1056/NEJM199704033361402"}],"replication":"The Dutch TME trial repeated the question with quality-controlled total mesorectal excision and found local recurrence 2.4 against 8.2 percent with no survival difference."},{"id":"swog-8794","kind":"trial","name":"SWOG 8794","aka":["SWOG 8794","SWOG S8794"],"tldr":"The trial that first showed radiotherapy soon after prostate surgery reduces the risk of the cancer spreading and helps men live longer, in an era before PSA was used to trigger treatment.","summary":"SWOG 8794 randomised 431 men with pT3N0M0 prostate cancer after radical prostatectomy to 60 to 64 Gy adjuvant radiotherapy or observation; 425 were eligible, 211 observed and 214 irradiated. Seventy men under observation eventually received radiotherapy anyway.\n\nMetastasis-free survival was significantly better with adjuvant radiotherapy: 93 of 214 events against 114 of 211, hazard ratio 0.71 (95 percent confidence interval 0.54 to 0.94, p=0.016). Overall survival also improved: 88 deaths of 214 against 110 of 211, hazard ratio 0.72 (0.55 to 0.96, p=0.023).\n\nSWOG 8794 and EORTC 22911 together made adjuvant radiotherapy standard after an adverse-pathology prostatectomy for more than a decade. What they did not test is the comparison that matters now, adjuvant radiotherapy against early salvage radiotherapy triggered by a rising PSA, and when RADICALS-RT, RAVES and GETUG-AFU 17 did test it, early salvage won on toxicity without losing control. Their result stands; the question moved.","status":"positive","asOf":"2026-09-25","links":[{"label":"SWOG 8794 long-term follow-up (Journal of Urology 2009)","url":"https://doi.org/10.1016/j.juro.2008.11.032"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk","prostate-bcr"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["swog"],"institutions":[],"pathways":[],"terms":["prostatectomy","neoadjuvant-adjuvant","biochemical-recurrence","salvage-therapy"],"trials":["eortc-22911","radicals-rt","artistic-meta-analysis"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"pT3N0M0 prostate cancer after radical prostatectomy: 60 to 64 Gy adjuvant radiotherapy against observation, with metastasis-free survival as the primary endpoint","sponsor":"SWOG Cancer Research Network, funded by the National Cancer Institute","result":"Metastasis-free survival hazard ratio 0.71 (95 percent confidence interval 0.54 to 0.94, p=0.016) and overall survival hazard ratio 0.72 (0.55 to 0.96, p=0.023) with adjuvant radiotherapy after prostatectomy for pT3N0M0 disease.","yearReported":2009,"enrolled":431,"enrolledBasis":"randomised","enrolledNote":"431 men were randomised and 425 were eligible; the eligible figure is the one analysed. The trial predates ClinicalTrials.gov registration.","outcomes":[{"endpoint":"Metastasis-free survival","primary":true,"unit":"events","arms":[{"name":"Adjuvant radiotherapy","n":214,"value":93},{"name":"Observation","n":211,"value":114}],"hr":0.71,"ci":[0.54,0.94],"p":"0.016","source":"https://doi.org/10.1016/j.juro.2008.11.032"},{"endpoint":"Overall survival","unit":"deaths","arms":[{"name":"Adjuvant radiotherapy","n":214,"value":88},{"name":"Observation","n":211,"value":110}],"hr":0.72,"ci":[0.55,0.96],"p":"0.023","source":"https://doi.org/10.1016/j.juro.2008.11.032"}],"replication":"EORTC 22911 (1,005 men) confirmed the biochemical progression-free survival benefit at a median 10.6 years but did not sustain a clinical progression-free survival benefit; the ARTISTIC meta-analysis of 2,153 men found no advantage for adjuvant over early salvage radiotherapy."},{"id":"swog-9346","kind":"trial","name":"SWOG 9346 (intermittent androgen deprivation)","aka":["SWOG 9346","S9346","INT-0162"],"tldr":"Taking breaks from hormone therapy for metastatic prostate cancer improved sex life and mood for a few months, but the trial could not rule out that it shortens life, so continuous treatment remained the standard.","summary":"SWOG 9346 enrolled 3,040 men with newly diagnosed metastatic hormone-sensitive prostate cancer, gave them all 7 months of a luteinising hormone-releasing hormone analogue with an antiandrogen, and randomised the 1,535 whose PSA fell to 4 ng/mL or lower to continuous (765) or intermittent (770) androgen deprivation.\n\nAt a median 9.8 years, median survival was 5.8 years with continuous therapy and 5.1 years with intermittent, hazard ratio for death with intermittent therapy 1.10 (90 percent confidence interval 0.99 to 1.23). The upper boundary of that interval exceeded the prespecified non-inferiority threshold of 1.20, but there were too few events to establish inferiority either. The authors described the finding as statistically inconclusive, which is an unusually honest way to report a trial that cost a decade.\n\nIntermittent therapy gave better erectile function and mental health at month 3 (p<0.001 and p=0.003) but not thereafter, and there was no significant difference in treatment-related high-grade adverse events.\n\nThe practical reading is that a man with metastatic disease should stay on continuous androgen deprivation, and that intermittent therapy is a reasonable discussion for non-metastatic disease, where the equivalent trials were less worrying. It is also a lesson in how expensive an inconclusive non-inferiority margin is.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00002651","url":"https://clinicaltrials.gov/study/NCT00002651"},{"label":"SWOG 9346 (New England Journal of Medicine 2013)","url":"https://doi.org/10.1056/NEJMoa1212299"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":[],"companies":["swog"],"institutions":[],"pathways":[],"terms":["adt","hormone-therapy","qol-pro","psa"],"trials":["chaarted","patch-transdermal-oestradiol"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002651","phase":"3","setting":"Newly diagnosed metastatic hormone-sensitive prostate cancer with a PSA of 5 ng/mL or more, after 7 months of a luteinising hormone-releasing hormone analogue and an antiandrogen brought the PSA to 4 ng/mL or lower: continuous against intermittent androgen deprivation, with co-primary objectives of non-inferior survival (upper hazard ratio boundary 1.20) and quality of life at 3 months","sponsor":"SWOG Cancer Research Network, funded by the National Cancer Institute","result":"Median survival 5.8 years with continuous against 5.1 years with intermittent androgen deprivation (hazard ratio 1.10, 90 percent confidence interval 0.99 to 1.23); non-inferiority not shown and inferiority not excluded. Erectile function and mental health better with intermittent therapy at 3 months only.","started":"1995-05","yearReported":2013,"enrolled":1535,"enrolledBasis":"randomised","enrolledNote":"3,040 men were enrolled and given 7 months of induction hormone therapy; 1,535 whose PSA fell to 4 ng/mL or lower were randomised and analysed.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"years","arms":[{"name":"Continuous androgen deprivation","n":765,"value":5.8,"note":"Confidence interval is 90 percent, as prespecified; hazard ratio is for death with intermittent therapy."},{"name":"Intermittent androgen deprivation","n":770,"value":5.1}],"hr":1.1,"ci":[0.99,1.23],"source":"https://doi.org/10.1056/NEJMoa1212299"}]},{"id":"swog-9916","kind":"trial","name":"SWOG 9916","aka":["SWOG 9916","S9916","INT-0161"],"tldr":"The second trial published the same day as TAX 327, showing the same thing by a different route: docetaxel beats mitoxantrone, though the partner drug it used has since been dropped for its side effects.","summary":"SWOG 9916 randomly assigned 770 men with metastatic androgen-independent prostate cancer to docetaxel with estramustine or to mitoxantrone with prednisone; 674 were eligible, 338 and 336 respectively.\n\nMedian overall survival was 17.5 months with docetaxel and estramustine against 15.6 months with mitoxantrone and prednisone (p=0.02 by log-rank), hazard ratio for death 0.80 (95 percent confidence interval 0.67 to 0.97). Median time to progression was 6.3 against 3.2 months (p<0.001). PSA declines of at least 50 percent occurred in 50 against 27 percent (p<0.001) and objective responses in 17 against 11 percent of men with bidimensionally measurable disease (p=0.30).\n\nThe reason estramustine is not used today is in the toxicity table: grade 3 or 4 neutropenic fever (p=0.01), nausea and vomiting (p<0.001) and cardiovascular events (p=0.001) were all more common with docetaxel and estramustine, and pain relief was no better than with mitoxantrone. TAX 327 achieved the same survival gain with prednisone rather than estramustine, so that is the regimen that survived.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00004001","url":"https://clinicaltrials.gov/study/NCT00004001"},{"label":"SWOG 9916 (New England Journal of Medicine 2004)","url":"https://doi.org/10.1056/NEJMoa041318"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel","estramustine","mitoxantrone","prednisone"],"companies":["swog"],"institutions":[],"pathways":[],"terms":["castration-resistance","psa50"],"trials":["tax-327"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00004001","phase":"3","setting":"Metastatic androgen-independent prostate cancer: estramustine 280 mg three times daily on days 1 to 5 with docetaxel 60 mg/m2 on day 2 and dexamethasone, against mitoxantrone 12 mg/m2 with prednisone, in 21-day cycles, with overall survival as the primary endpoint","sponsor":"SWOG Cancer Research Network, funded by the National Cancer Institute","result":"Median overall survival 17.5 against 15.6 months (hazard ratio for death 0.80, 95 percent confidence interval 0.67 to 0.97, p=0.02) and time to progression 6.3 against 3.2 months, at the cost of more neutropenic fever, vomiting and cardiovascular events.","started":"1999-10","yearReported":2004,"enrolled":770,"enrolledBasis":"randomised","enrolledNote":"770 men were randomly assigned and 674 were eligible; the eligible figure is the one analysed.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Docetaxel with estramustine","n":338,"value":17.5},{"name":"Mitoxantrone with prednisone","n":336,"value":15.6}],"hr":0.8,"ci":[0.67,0.97],"p":"0.02","source":"https://doi.org/10.1056/NEJMoa041318"},{"endpoint":"Time to progression (median)","unit":"months","arms":[{"name":"Docetaxel with estramustine","n":338,"value":6.3},{"name":"Mitoxantrone with prednisone","n":336,"value":3.2}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa041318"}],"replication":"TAX 327, published the same day, found the same survival advantage for docetaxel with prednisone and without the extra toxicity of estramustine."},{"id":"swog-s0421-atrasentan","kind":"trial","name":"SWOG S0421","aka":["SWOG S0421","S0421","atrasentan with docetaxel"],"tldr":"Adding an endothelin blocker to chemotherapy changed nothing, not survival, not progression, not pain.","summary":"SWOG S0421 randomised 994 men with metastatic castration-resistant prostate cancer and bone metastases to docetaxel with atrasentan 10 mg daily or placebo for up to 12 cycles, with the option to continue the study drug for up to 52 weeks in the absence of progression. It was halted early for futility at a planned interim analysis in April 2011.\n\nMedian progression-free survival was 9.2 months (95 percent confidence interval 8.5 to 9.9) with atrasentan and 9.1 months (8.4 to 10.2) with placebo, hazard ratio 1.02 (0.89 to 1.16, p=0.81). Median overall survival was 17.8 months (16.4 to 19.8) against 17.6 months (16.4 to 20.1), hazard ratio 1.04 (0.90 to 1.19, p=0.64). Grade 3 or greater toxicity occurred in 278 of 492 men (57 percent) with atrasentan and 294 of 486 (60 percent) with placebo, p=0.22, and three deaths in the atrasentan group and seven in the placebo group were judged possibly or probably due to protocol treatment.\n\nThe separately published patient-reported outcomes reinforce the null: clinically meaningful pain palliation in 44.0 percent with atrasentan against 41.7 percent with placebo (p=0.70), functional status improvement in 28.7 against 24.2 percent (p=0.13), and no difference over time in Brief Pain Inventory worst pain scores (0.13 points, p=0.23).","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00134056","url":"https://clinicaltrials.gov/study/NCT00134056"},{"label":"SWOG S0421 (Lancet Oncology 2013)","url":"https://doi.org/10.1016/S1470-2045(13)70294-8"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":["ednra"],"drugs":["atrasentan","docetaxel"],"companies":["swog","abbvie"],"institutions":[],"pathways":[],"terms":["bone-metastases","castration-resistance","qol-pro"],"trials":["enthuse-m1-zibotentan","tax-327"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00134056","phase":"3","setting":"Metastatic castration-resistant prostate cancer with bone metastases, stratified by progression type, baseline pain, extraskeletal metastases and bisphosphonate use: docetaxel 75 mg/m2 every 21 days with atrasentan 10 mg daily or placebo for up to 12 cycles, with co-primary endpoints of progression-free survival and overall survival","sponsor":"SWOG Cancer Research Network, funded by the National Cancer Institute with Sanofi-Aventis and Abbott Laboratories","result":"Median overall survival 17.8 against 17.6 months (hazard ratio 1.04, 95 percent confidence interval 0.90 to 1.19) and progression-free survival 9.2 against 9.1 months (1.02, 0.89 to 1.16); halted early for futility, and no difference in pain palliation.","started":"2006-08","yearReported":2013,"enrolled":994,"enrolledBasis":"randomised","enrolledNote":"994 men were randomly assigned, 498 to atrasentan and 496 to placebo; the trial was halted early for futility in April 2011.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Docetaxel with atrasentan","n":498,"value":17.8},{"name":"Docetaxel with placebo","n":496,"value":17.6}],"hr":1.04,"ci":[0.9,1.19],"p":"0.64","source":"https://doi.org/10.1016/S1470-2045(13)70294-8"},{"endpoint":"Progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Docetaxel with atrasentan","n":498,"value":9.2},{"name":"Docetaxel with placebo","n":496,"value":9.1}],"hr":1.02,"ci":[0.89,1.16],"p":"0.81","source":"https://doi.org/10.1016/S1470-2045(13)70294-8"}],"replication":"ENTHUSE M1 found the same for zibotentan, the other endothelin A antagonist, in 594 men."},{"id":"swog-s0809","kind":"trial","name":"SWOG S0809","aka":[],"tldr":"The only prospective trial of chemotherapy followed by chemoradiotherapy after surgery for bile duct and gallbladder cancer: 79 patients, a third with gallbladder cancer, had two-year survival of 65 percent and median survival of 35 months, similar whether or not the margin was clear. It is the basis on which some centres offer radiotherapy after an R1 resection.","summary":"SWOG S0809 was a single-arm intergroup phase 2 for patients with extrahepatic cholangiocarcinoma or gallbladder carcinoma after radical resection with pT2-4 stage, positive nodes or positive margins. Patients received four cycles of gemcitabine 1,000 mg/m² days 1 and 8 with capecitabine 1,500 mg/m² per day days 1 to 14 every 21 days, then concurrent capecitabine 1,330 mg/m² per day with radiotherapy of 45 Gy to the regional lymphatics and 54 to 59.4 Gy to the tumour bed. Of 79 eligible patients (R0 54, R1 25; extrahepatic cholangiocarcinoma 68 percent, gallbladder carcinoma 32 percent), 86 percent completed treatment. Two-year overall survival was 65 percent (95 percent confidence interval 53 to 74), 67 percent after R0 and 60 percent after R1 resection, and median overall survival was 35 months (R0 34, R1 35). Local, distant and combined relapse occurred in 14, 24 and 9 patients. Grade 3 and 4 adverse effects occurred in 52 and 11 percent (neutropenia 44 percent, hand-foot syndrome 11 percent, diarrhoea 8 percent) with one death from gastrointestinal haemorrhage. A 2024 National Cancer Database analysis of 4,997 patients meeting S0809 criteria found median survival of 36.9 months with chemoradiation and a propensity-matched hazard ratio of 0.86 against chemotherapy alone. No randomised trial has confirmed adjuvant chemoradiation in biliary cancer; in the UK it is not routine, and BILCAP capecitabine is the adjuvant standard, with chemoradiation considered case by case for R1 margins.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00789958","url":"https://clinicaltrials.gov/study/NCT00789958"},{"label":"Ben-Josef et al., JCO 2015: SWOG S0809","url":"https://doi.org/10.1200/JCO.2014.60.2219"},{"label":"Adjuvant chemoradiation in resected biliary adenocarcinoma: evaluation of SWOG S0809 with a large national database (Ann Surg Oncol 2024)","url":"https://doi.org/10.1245/s10434-024-15117-y"}],"tags":[],"related":["bilcap","polcagb"],"cancers":["gallbladder","extrahepatic-cholangiocarcinoma","cholangiocarcinoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","capecitabine"],"companies":["swog"],"institutions":[],"pathways":[],"terms":["chemoradiation","radiotherapy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-swog-s0809-adjuvant-chemoradiation-jco-2015","paper-wang-adjuvant-chemoradiotherapy-nomogram-gallbladder-cancer-jco-2011"],"journals":[],"dependsOn":[],"notes":["Key figures: 79 eligible (R0 54, R1 25; extrahepatic cholangiocarcinoma 68 percent, gallbladder carcinoma 32 percent); two-year overall survival 65 percent (53 to 74), 67 percent after R0 and 60 percent after R1; median overall survival 35 months; grade 3 and 4 adverse effects 52 and 11 percent with one death from gastrointestinal haemorrhage. A 2024 National Cancer Database analysis of 4,997 S0809-eligible patients found median survival of 36.9 months with chemoradiation (hazard ratio 0.86 against chemotherapy alone, propensity matched). Not routine in the UK; considered case by case after an R1 margin."],"nct":"NCT00789958","phase":"2","setting":"Adjuvant gemcitabine and capecitabine for four cycles followed by capecitabine with radiotherapy (45 Gy to regional nodes, 54 to 59.4 Gy to the tumour bed) after resection of pT2-4, node-positive or margin-positive extrahepatic cholangiocarcinoma or gallbladder carcinoma","sponsor":"SWOG Cancer Research Network","result":"2-year OS 65% (R0 67%, R1 60%); median OS 35 months; grade 3 and 4 toxicity 52% and 11%.","started":"2008-12","yearReported":2015,"enrolled":105,"enrolledBasis":"registry","outcomes":[{"endpoint":"2-year overall survival by margin","unit":"%","arms":[{"name":"R0","n":54,"value":67},{"name":"R1","n":25,"value":60}],"source":"https://doi.org/10.1200/JCO.2014.60.2219"},{"endpoint":"Median overall survival","unit":"months","arms":[{"name":"All eligible","n":79,"value":35}],"source":"https://doi.org/10.1200/JCO.2014.60.2219"}]},{"id":"swog-s1406","kind":"trial","name":"SWOG S1406","aka":[],"tldr":"The trial that explained why BRAF drugs alone fail in bowel cancer: blocking BRAF wakes up EGFR, so both must be blocked at once.","summary":"SWOG S1406 randomised 106 patients with BRAF V600E-mutant metastatic colorectal cancer treated with one or two previous regimens to irinotecan and cetuximab with or without vemurafenib 960 mg twice daily. Progression-free survival, the primary endpoint, improved with vemurafenib (hazard ratio 0.50, p=0.001), the response rate was 17 against 4 percent (p=0.05) and disease control 65 against 21 percent. Blockade of BRAF V600E alone causes feedback upregulation of EGFR in colorectal cancer, which cetuximab impedes; that mechanism, first shown in the laboratory, is what S1406 confirmed in patients and what BEACON CRC then turned into an approved doublet with encorafenib.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02164916","url":"https://clinicaltrials.gov/study/NCT02164916"},{"label":"SWOG S1406: irinotecan and cetuximab with or without vemurafenib in BRAF-mutant metastatic colorectal cancer (Journal of Clinical Oncology 2021)","url":"https://doi.org/10.1200/JCO.20.01994"}],"tags":[],"related":[],"cancers":["colorectal","braf-v600e-colorectal"],"sections":[],"technologies":["kinase-inhibitors","monoclonal-antibody"],"targets":["braf","egfr"],"drugs":["vemurafenib","cetuximab","irinotecan"],"companies":["swog"],"institutions":[],"pathways":[],"terms":[],"trials":["beacon-crc","breakwater"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02164916","phase":"2","setting":"Previously treated BRAF V600E-mutant metastatic colorectal cancer: irinotecan and cetuximab with or without vemurafenib","sponsor":"SWOG Cancer Research Network","result":"Progression-free survival hazard ratio 0.50 with vemurafenib added; response 17 against 4 percent.","started":"2014-11","yearReported":2021,"enrolled":106,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"hazard ratio","arms":[{"name":"Irinotecan, cetuximab and vemurafenib","value":0.5},{"name":"Irinotecan and cetuximab","value":1}],"hr":0.5,"p":"0.001","source":"https://doi.org/10.1200/JCO.20.01994"}],"replication":"BEACON CRC confirmed the principle with encorafenib and cetuximab in a phase 3 trial; BREAKWATER moved it to first line."},{"id":"swog-s1418","kind":"trial","name":"SWOG S1418 / NRG BR006","aka":["S1418","NRG-BR006","SWOG S1418"],"tldr":"SWOG S1418 is the trial that will say whether a year of pembrolizumab after surgery, on its own, helps women whose triple-negative breast cancer survived pre-operative chemotherapy. It finished recruiting 1,195 patients and is due to report from 2026.","summary":"SWOG S1418/NRG BR006 (NCT02954874) randomised 1,195 patients with triple-negative breast cancer and residual invasive disease of at least 1 cm or positive lymph nodes (ypN1mi to ypN3) after neoadjuvant chemotherapy to one year of pembrolizumab or observation, with radiotherapy per standard of care; the primary endpoint is invasive disease-free survival, with fatigue and physical function as co-primary patient-reported endpoints. It opened in January 2017, before KEYNOTE-522 made neoadjuvant pembrolizumab standard, so it isolates the adjuvant contribution of pembrolizumab in a population that has not had it before surgery, a question KEYNOTE-522 could not answer. The registry lists primary completion in August 2026 and the trial as active, not recruiting; no results were indexed in September 2026. In England the matching NICE appraisal, pembrolizumab as adjuvant treatment after neoadjuvant chemotherapy (GID-TA11724), is awaiting development.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02954874","url":"https://clinicaltrials.gov/study/NCT02954874"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["swog"],"institutions":["nci"],"pathways":[],"terms":["rcb","efs","tnbc-residual-disease-decision"],"trials":["keynote-522","a-brave","impassion030"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Key facts: adjuvant pembrolizumab for one year versus observation after residual disease of 1 cm or more or node-positive disease following neoadjuvant chemotherapy; primary endpoint invasive disease-free survival; 1,195 enrolled; primary completion August 2026 (registry); no results in September 2026."],"nct":"NCT02954874","phase":"3","setting":"Triple-negative breast cancer with residual invasive disease of 1 cm or more, or positive lymph nodes, after neoadjuvant chemotherapy without immunotherapy: one year of adjuvant pembrolizumab versus observation, United States, Canada and Puerto Rico","sponsor":"National Cancer Institute (NCI), SWOG and NRG Oncology","started":"2017-01-18","startedType":"actual","enrolled":1195,"enrolledBasis":"registry","outcomes":[]},{"id":"swog-s1505","kind":"trial","name":"SWOG S1505","aka":["S1505"],"tldr":"SWOG S1505 gave people with operable pancreatic cancer three months of chemotherapy before and after surgery with one of the two modern regimens; about half were alive at two years with either, no better than the 40 percent threshold the trial set from adjuvant-only history, and a third of the patients enrolled turned out not to have resectable tumours on central review.","summary":"S1505 enrolled 147 patients between 2015 and 2018; 43 (29 percent) were ineligible at central radiology review because their disease exceeded resectability criteria, leaving 102 evaluable patients (55 on modified FOLFIRINOX, 47 on gemcitabine plus nab-paclitaxel). In each arm 84 to 85 percent completed preoperative chemotherapy, 73 and 70 percent underwent resection and 49 and 40 percent completed all treatment. Two-year overall survival was 47 percent (95 percent confidence interval 31 to 61) with modified FOLFIRINOX and 48 percent (31 to 63) with gemcitabine plus nab-paclitaxel, median overall survival 23.2 and 23.6 months, and neither arm's estimate exceeded the a priori 40 percent threshold; median disease-free survival after resection was 10.9 and 14.2 months. The trial showed perioperative chemotherapy is deliverable with high resection rates but did not show it improves survival over adjuvant treatment, and it exposed how often local teams over-call resectability, a quality-control problem carried into Alliance A021806.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02562716","url":"https://clinicaltrials.gov/study/NCT02562716"},{"label":"Sohal et al., SWOG S1505 (JAMA Oncology 2021)","url":"https://doi.org/10.1001/jamaoncol.2020.7328"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["folfirinox","gemcitabine-nab-paclitaxel"],"companies":["swog"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","resectability"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02562716","phase":"2","setting":"Resectable pancreatic adenocarcinoma across the US National Clinical Trials Network: 12 weeks of modified FOLFIRINOX or gemcitabine plus nab-paclitaxel before and 12 weeks after surgery, a pick-the-winner randomised phase 2 with two-year overall survival as the primary endpoint","sponsor":"SWOG Cancer Research Network / National Cancer Institute","result":"Two-year overall survival 47 percent with perioperative modified FOLFIRINOX and 48 percent with perioperative gemcitabine plus nab-paclitaxel; neither exceeded the 40 percent historical threshold; median overall survival 23.2 and 23.6 months.","started":"2016-01-06","startedType":"actual","yearReported":2021,"enrolled":147,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 2 years (eligible patients)","primary":true,"unit":"%","arms":[{"name":"Perioperative mFOLFIRINOX","n":55,"value":47,"note":"95% CI 31 to 61"},{"name":"Perioperative gemcitabine + nab-paclitaxel","n":47,"value":48,"note":"95% CI 31 to 63"}],"source":"https://doi.org/10.1001/jamaoncol.2020.7328"}]},{"id":"swog-s1801","kind":"trial","name":"SWOG S1801","aka":[],"tldr":"Simply moving three doses of the same drug to before surgery improved outcomes, a result that changed how the field thinks about timing.","summary":"2-year EFS 72% vs 49% (HR 0.58), NEJM 2023. Same total drug exposure in both arms; the difference is attributed to priming the immune response while the tumour and its draining nodes are still present. Three-year follow-up presented at ESMO 2025 sustained the benefit. Together with NADINA it established neoadjuvant immunotherapy as standard for resectable stage III disease.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03698019","url":"https://clinicaltrials.gov/study/NCT03698019"},{"label":"NEJM 2023","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2211437"}],"tags":[],"related":[],"cancers":["melanoma","stage-iii-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab"],"companies":["swog"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":[],"people":["sapna-patel"],"bottlenecks":[],"keyPapers":["paper-swog-s1801-n-engl-j-med-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03698019","phase":"2","setting":"Resectable stage IIIB-IV melanoma: three doses of pembrolizumab before surgery then 15 after, vs 18 doses after surgery","sponsor":"SWOG / NCI","result":"2-year EFS 72% vs 49%; HR 0.58.","started":"2019-02-15","startedType":"actual","yearReported":2022,"enrolled":313,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 2 years","primary":true,"unit":"%","arms":[{"name":"Neoadjuvant + adjuvant pembrolizumab","value":72},{"name":"Adjuvant pembrolizumab","value":49}],"hr":0.58,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2211437"}],"replication":"Replicated in principle by NADINA with a different regimen."},{"id":"swog-s1815","kind":"trial","name":"SWOG S1815","aka":["S1815"],"tldr":"Adding a third chemotherapy drug, nab-paclitaxel, to gemcitabine and cisplatin did not help people with advanced bile duct or gallbladder cancer live longer in this 452-patient US trial, although the gallbladder subgroup showed a hint of slower progression that needs its own test.","summary":"SWOG S1815 (NCT03768414) randomised 452 patients with newly diagnosed locally advanced unresectable or metastatic biliary tract cancer 2:1 to gemcitabine 800 mg/m², cisplatin 25 mg/m² and nab-paclitaxel 100 mg/m² (GAP) or gemcitabine 1,000 mg/m² and cisplatin 25 mg/m² (GC), days 1 and 8 every 21 days. Of 441 eligible and analysable participants, 67 percent had intrahepatic cholangiocarcinoma, 16 percent gallbladder carcinoma and 17 percent extrahepatic cholangiocarcinoma. Median overall survival was 14.0 months with GAP and 13.6 with GC (hazard ratio 0.91, 95 percent confidence interval 0.72 to 1.14, p 0.41) and median progression-free survival 7.5 versus 6.3 months (hazard ratio 0.89, p 0.32). In exploratory subsets the benefit of GAP appeared greater in locally advanced disease (not significant) and the progression-free survival improvement was greater in gallbladder carcinoma than in cholangiocarcinoma (interaction p 0.01), but not overall survival (interaction p 0.28). The trial closes the question of taxane triplets as a general first-line standard and leaves the gallbladder signal as a hypothesis for the Indian RUGB trial and Chinese gemcitabine-nab-paclitaxel trials to pursue.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03768414","url":"https://clinicaltrials.gov/study/NCT03768414"},{"label":"Shroff et al., JCO 2025: SWOG S1815","url":"https://doi.org/10.1200/JCO-24-01383"}],"tags":["failure"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine-cisplatin","nab-paclitaxel","gemcitabine","cisplatin"],"companies":["swog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03768414","phase":"3","setting":"Newly diagnosed advanced biliary tract cancer (intrahepatic, extrahepatic, gallbladder): gemcitabine, cisplatin and nab-paclitaxel versus gemcitabine and cisplatin, randomised 2:1","sponsor":"SWOG Cancer Research Network","result":"OS 14.0 vs 13.6 months, HR 0.91 (0.72 to 1.14), p=0.41; PFS 7.5 vs 6.3 months, HR 0.89; gallbladder PFS interaction p=0.01, OS interaction p=0.28.","started":"2019-02-07","startedType":"actual","yearReported":2025,"enrolled":452,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Gemcitabine + cisplatin + nab-paclitaxel","value":14},{"name":"Gemcitabine + cisplatin","value":13.6}],"hr":0.91,"ci":[0.72,1.14],"p":"0.41","source":"https://doi.org/10.1200/JCO-24-01383"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Gemcitabine + cisplatin + nab-paclitaxel","value":7.5},{"name":"Gemcitabine + cisplatin","value":6.3}],"hr":0.89,"ci":[0.71,1.12],"p":"0.32","source":"https://doi.org/10.1200/JCO-24-01383"}]},{"id":"swog-s1826","kind":"trial","name":"SWOG S1826","aka":[],"tldr":"Immunotherapy plus chemotherapy beat the previous best regimen with far less nerve damage, in the first Hodgkin trial to enrol children and adults together; approved March 2026.","summary":"1-year PFS 94% vs 86%; 2-year PFS 92% vs 83% (HR 0.45, NEJM 2024). Peripheral neuropathy 28.1% vs 54.2%; fewer treatment discontinuations. Radiotherapy given to <1%. FDA approval 20 March 2026 for ages 12+. Now the frontline standard for advanced-stage disease in North America; HD21's BrECADD is the European alternative.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03907488","url":"https://clinicaltrials.gov/study/NCT03907488"},{"label":"FDA approval (Mar 2026)","url":"https://www.targetedonc.com/view/fda-approves-nivolumab-plus-avd-for-classical-hodgkin-lymphoma"}],"tags":[],"related":["src-targeted-oncology"],"cancers":["hodgkin-lymphoma","advanced-stage-classical-hodgkin-lymphoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["nivolumab","brentuximab-vedotin","doxorubicin"],"companies":["swog","childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["kara-kelly","alex-herrera"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03907488","phase":"3","setting":"Untreated stage III-IV classical Hodgkin lymphoma, age ≥12: nivolumab + AVD vs brentuximab vedotin + AVD","sponsor":"SWOG / NCI (with COG)","result":"2-year PFS 92% vs 83%, HR 0.45.","started":"2019-08-29","startedType":"actual","yearReported":2023,"enrolled":994,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 2 years","primary":true,"unit":"%","arms":[{"name":"Nivolumab-AVD","n":489,"value":92},{"name":"BV-AVD","n":487,"value":83}],"hr":0.45,"ci":[0.3,0.65],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2405888"},{"endpoint":"Any-grade peripheral neuropathy","unit":"%","arms":[{"name":"Nivolumab-AVD","value":28.1},{"name":"BV-AVD","value":54.2}],"source":"https://doi.org/10.1056/NEJMoa2405888"}],"replication":"Consistent with phase 2 N-AVD data (CheckMate 205 cohort D) and with pembrolizumab-AVD single-arm studies; no second randomised trial yet."},{"id":"nct07322341","kind":"trial","name":"SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of atezolizumab in lung cancer, run by University of Washington, now recruiting.","summary":"SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer is a phase 2, interventional study registered as NCT07322341 by University of Washington, with a registry enrolment figure of 32 participants, started 2026-10-01 and due to reach its primary completion in 2030-11-01. Interventions recorded: Atezolizumab; CXCR1/2 Inhibitor SX-682; Biospecimen Collection; Computed Tomography; Magnetic Resonance Imaging; Biopsy Procedure. Conditions listed: Advanced Lung Non-Small Cell Carcinoma; Metastatic Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8. Primary outcome: Objective response rate. Lung eligibility wording from the registry: \"* Pathologically or cytologically confirmed non-small cell lung cancer with no known oncogenic EGFR mutation, ALK fusion, ROS1 fusion or RET fusions\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07322341","url":"https://clinicaltrials.gov/study/NCT07322341"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07322341","phase":"2","setting":"A Phase 2 Trial of SX-682 and Atezolizumab in Patients With Advanced NSCLC Who Progressed on Prior Chemotherapy and Immune Checkpoint Inhibitor (ICI) Therapy","sponsor":"University of Washington","started":"2026-10-01","startedType":"estimated","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05570825","kind":"trial","name":"SX-682 With Pembrolizumab for the Treatment of Metastatic or Recurrent Stage IIIC or IV Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of pembrolizumab in lung cancer, run by University of Washington, now recruiting.","summary":"SX-682 With Pembrolizumab for the Treatment of Metastatic or Recurrent Stage IIIC or IV Non-Small Cell Lung Cancer is a phase 2, interventional study registered as NCT05570825 by University of Washington, with a registry enrolment figure of 30 participants, started 2023-04-06 and due to reach its primary completion in 2027-07-01. Interventions recorded: Biopsy; Biospecimen Collection; Computed Tomography; CXCR1/2 Inhibitor SX-682; Magnetic Resonance Imaging; Pembrolizumab; Positron Emission Tomography. Conditions listed: Metastatic Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8. Primary outcome: Best objective response rate. Lung eligibility wording from the registry: \"* Pathologically or cytologically confirmed non-small cell lung cancer with no known oncogenic EGFR mutation, ALK rearrangement, ROS1 rearrangement or RET rearrangement\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05570825","url":"https://clinicaltrials.gov/study/NCT05570825"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05570825","phase":"2","setting":"A Phase 2 Trial of SX-682 and Pembrolizumab in Patients With Treatment Naive Stage IV or Recurrent Non-Small Cell Lung Cancer","sponsor":"University of Washington","started":"2023-04-06","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04205630","kind":"trial","name":"SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma","aka":[],"tldr":"A phase 2 trial of Trastuzumab duocarmazine in Endometrial cancer, run by Byondis B.V., completed.","summary":"SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma is a phase 2 interventional study registered as NCT04205630 by Byondis B.V., with 64 participants recorded, started 2020-05-28 and reaching its primary completion in 2023-01-26. Interventions recorded: SYD985. Conditions recorded: Endometrial Cancer.\n\nLinked to the drug Trastuzumab duocarmazine because the registry names it among its interventions and Endometrial cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04205630","url":"https://clinicaltrials.gov/study/NCT04205630"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["trastuzumab-duocarmazine"],"companies":["byondis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04205630","phase":"2","setting":"A Single-arm Phase II Trial to Evaluate the Safety and Efficacy of the Antibody-Drug Conjugate (ADC) SYD985 in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Endometrial Carcinoma Who Previously Progressed on or After First Line Platinum-based Chemotherapy","sponsor":"Byondis B.V.","started":"2020-05-28","startedType":"actual","yearReported":2024,"enrolled":64,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR)","primary":true,"unit":"participants","arms":[{"name":"SYD985","n":61,"value":20,"note":"Figures from the ClinicalTrials.gov results section (first posted 2024-05-30), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04205630?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"SYD985","n":64,"value":16.3,"note":"95% CI 11.6 to 20.5; Figures from the ClinicalTrials.gov results section (first posted 2024-05-30), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04205630?tab=results"},{"endpoint":"Progression-Free Survival (PFS)","unit":"months","arms":[{"name":"SYD985","n":64,"value":5.6,"note":"95% CI 4.0 to 7.6; Figures from the ClinicalTrials.gov results section (first posted 2024-05-30), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04205630?tab=results"}]},{"id":"nct03262935","kind":"trial","name":"SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial of Trastuzumab duocarmazine, Lapatinib, Capecitabine, Trastuzumab, Vinorelbine and Eribulin in Breast cancer, run by Byondis B.V., completed.","summary":"SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer is a phase 3 interventional study registered as NCT03262935 by Byondis B.V., with 437 participants recorded, started 2017-12-15 and reaching its primary completion in 2021-03-31. Interventions recorded: (vic-)trastuzumab duocarmazine, Physician's choice. Conditions recorded: Metastatic Breast Cancer.\n\nLinked to the drug Trastuzumab duocarmazine because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03262935","url":"https://clinicaltrials.gov/study/NCT03262935"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["trastuzumab-duocarmazine","lapatinib","capecitabine","trastuzumab","vinorelbine","eribulin"],"companies":["byondis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03262935","phase":"3","setting":"A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer","sponsor":"Byondis B.V.","started":"2017-12-15","startedType":"actual","yearReported":2023,"enrolled":437,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival","primary":true,"unit":"months","arms":[{"name":"(Vic-)Trastuzumab Duocarmazine","n":291,"value":7,"note":"95% CI 5.4 to 7.2; Figures from the ClinicalTrials.gov results section (first posted 2023-10-19), not from a publication"},{"name":"Physician's Choice","n":146,"value":4.9,"note":"95% CI 4.0 to 5.5"}],"hr":0.6401,"ci":[0.4885,0.8389],"p":"0.002","source":"https://clinicaltrials.gov/study/NCT03262935?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"(Vic-)Trastuzumab Duocarmazine","n":291,"value":21,"note":"95% CI 18.1 to 25.0; Figures from the ClinicalTrials.gov results section (first posted 2023-10-19), not from a publication"},{"name":"Physician's Choice","n":146,"value":19.5,"note":"95% CI 14.2 to 23.1"}],"hr":0.868,"ci":[0.676,1.1145],"p":"0.236","source":"https://clinicaltrials.gov/study/NCT03262935?tab=results"},{"endpoint":"Objective Response Rate","unit":"%","arms":[{"name":"(Vic-)Trastuzumab Duocarmazine","n":252,"value":27.8,"note":"95% CI 22.3 to 33.7; Figures from the ClinicalTrials.gov results section (first posted 2023-10-19), not from a publication"},{"name":"Physician's Choice","n":122,"value":29.5,"note":"95% CI 21.6 to 38.4"}],"p":"0.732","source":"https://clinicaltrials.gov/study/NCT03262935?tab=results"}]},{"id":"nct07662811","kind":"trial","name":"SYHX2011 in Combination With Carboplatin and Enlonstobart as First-Line Therapy for Squamous Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2/3 trial of carboplatin, nab-paclitaxel and tislelizumab in lung cancer, run by Shanghai Chest Hospital, not yet recruiting.","summary":"SYHX2011 in Combination With Carboplatin and Enlonstobart as First-Line Therapy for Squamous Non-Small Cell Lung Cancer is a phase 2/3, randomised interventional study registered as NCT07662811 by Shanghai Chest Hospital, with a registry enrolment figure of 396 participants, started 2026-06-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: SYHX2011; Carboplatin; Enlonstobart; Nab-Paclitaxel; Carboplatin; Tislelizumab. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Objective Response Rate (ORR) for phase II; Progression Free Survival (PFS) for phase III. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed locally advanced or metastatic squamous non-small cell lung cancer (Stage IIIB, IIIC, or IV according to the IASLC 9th Edition TNM Staging System), ineligible for radical surgery and/or radical radiotherapy\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07662811","url":"https://clinicaltrials.gov/study/NCT07662811"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-squamous-cell-carcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","nab-paclitaxel","tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07662811","phase":"2/3","setting":"SYHX2011 in Combination With Carboplatin and Enlonstobart Versus Nab-Paclitaxel Plus Carboplatin and Tislelizumab as First-Line Therapy for Squamous Non-Small Cell Lung Cancer: A Multicenter, Open-Label, Phase II/III Study","sponsor":"Shanghai Chest Hospital","started":"2026-06-01","startedType":"estimated","enrolled":396,"enrolledBasis":"registry","outcomes":[]},{"id":"symbiotic-gi-03","kind":"trial","name":"Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer","aka":["Symbiotic-GI-03"],"tldr":"A phase 3 trial testing PF-08634404 in colorectal cancer, now recruiting.","summary":"Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer is a phase 3 interventional study registered as NCT07222800, led by Pfizer, and recruiting on the registry. Official title: An interventional, phase 3, double-blind, randomised study to evaluate the efficacy and safety of PF-08634404 in combination with chemotherapy versus bevacizumab in combination with chemotherapy in treatment-naïve participants with metastatic colorectal cancer. Planned enrolment is 800 participants (estimated). The study started in 2025-12-11 and primary completion is expected in 2030-03-29. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07222800","url":"https://clinicaltrials.gov/study/NCT07222800"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-08634404"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07222800","phase":"3","setting":"An interventional, phase 3, double-blind, randomized study to evaluate the efficacy and safety of PF-08634404 in combination with chemotherapy versus bevacizumab in combination with chemotherapy in treatment-naïve participants with metastatic colorectal cancer","sponsor":"Pfizer","started":"2025-12-11","startedType":"actual","enrolled":800,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07227012","kind":"trial","name":"Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a","aka":["Symbiotic-GI-13"],"tldr":"A phase 1/2 trial of PF-08634404, Ipilimumab in hepatocellular carcinoma, run by Pfizer, now recruiting.","summary":"Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body. is a phase 1/2 interventional study registered as NCT07227012 by Pfizer, with 138 participants planned, started 2025-12-01 and due to reach its primary completion in 2027-10-18. Interventions recorded: PF-08634404, Ipilimumab. Conditions listed: Carcinoma, Hepatocellular, Hepatocellular Cancer, Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07227012","url":"https://clinicaltrials.gov/study/NCT07227012"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-08634404","ipilimumab"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07227012","phase":"1/2","setting":"AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 AS MONOTHERAPY AND COMBINATION THERAPY IN ADULT PARTICIPANTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA","sponsor":"Pfizer","started":"2025-12-01","startedType":"actual","enrolled":138,"enrolledBasis":"registry","outcomes":[]},{"id":"symbiotic-gi-16","kind":"trial","name":"Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer","aka":["Symbiotic-GI-16"],"tldr":"A phase 2/3 trial testing PF-08634404 in gastric & gastro-oesophageal junction cancer and oesophageal cancer, now recruiting.","summary":"Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer is a phase 2/3 interventional study registered as NCT07392892, led by Pfizer, and recruiting on the registry. Official title: A phase 2/3 interventional study of PF-08634404 in combination with chemotherapy in treatment-naïve participants with locally advanced or metastatic gastric, gastroesophageal junction, or oesophageal adenocarcinoma. Planned enrolment is 840 participants (estimated). The study started in 2026-05-14 and primary completion is expected in 2031-07-22. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07392892","url":"https://clinicaltrials.gov/study/NCT07392892"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gastric","esophageal","oesophageal-adenocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-08634404"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07392892","phase":"2/3","setting":"A phase 2/3 interventional study of PF-08634404 in combination with chemotherapy in treatment-naïve participants with locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma","sponsor":"Pfizer","started":"2026-05-14","startedType":"actual","enrolled":840,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07421700","kind":"trial","name":"Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer","aka":["Symbiotic-GU-06"],"tldr":"A phase 1/2 trial of PF-08634404 and Enfortumab vedotin in bladder & urothelial cancer, run by Pfizer, now recruiting.","summary":"Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer is a phase 1/2 interventional study registered as NCT07421700 by Pfizer, with 132 participants planned, started 2026-03-11 and due to reach its primary completion in 2027-12-06. Interventions recorded: PF-08634404 and Enfortumab Vedotin.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07421700","url":"https://clinicaltrials.gov/study/NCT07421700"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["pf-08634404","enfortumab-vedotin"],"companies":["pfizer","astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07421700","phase":"1/2","setting":"AN INTERVENTIONAL PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER","sponsor":"Pfizer","started":"2026-03-11","startedType":"actual","enrolled":132,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07227415","kind":"trial","name":"Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With ","aka":["Symbiotic-GU-08"],"tldr":"A phase 1/2 trial of PF-08634404, Ipilimumab, Axitinib in renal cell carcinoma, run by Pfizer, now recruiting.","summary":"Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer is a phase 1/2 interventional study registered as NCT07227415 by Pfizer, with 224 participants planned, started 2026-02-10 and due to reach its primary completion in 2027-11-02. Interventions recorded: PF-08634404, Ipilimumab, Axitinib. Conditions listed: Carcinoma, Renal Cell, Advanced Renal Cell Carcinoma, Renal Cancer, Renal Neoplasm. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07227415","url":"https://clinicaltrials.gov/study/NCT07227415"}],"tags":["ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-08634404","ipilimumab","axitinib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07227415","phase":"1/2","setting":"AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA","sponsor":"Pfizer","started":"2026-02-10","startedType":"actual","enrolled":224,"enrolledBasis":"registry","outcomes":[]},{"id":"symbiotic-lung-01","kind":"trial","name":"Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","aka":["Symbiotic-Lung-01"],"tldr":"A phase 3 trial testing PF-08634404 in non-small-cell lung cancer, now recruiting.","summary":"Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT07222566, led by Pfizer, and recruiting on the registry. Official title: An interventional phase 3, double-blind, randomised study to evaluate efficacy and safety of PF-08634404 in combination with chemotherapy versus pembrolizumab in combination with chemotherapy in adult participants with locally advanced or metastatic non-small cell lung cancer. Planned enrolment is 1410 participants (estimated). The study started in 2026-01-06 and primary completion is expected in 2029-02-27. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07222566","url":"https://clinicaltrials.gov/study/NCT07222566"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-08634404"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07222566","phase":"3","setting":"An interventional phase 3, double-blind, randomized study to evaluate efficacy and safety of PF-08634404 in combination with chemotherapy versus pembrolizumab in combination with chemotherapy in adult participants with locally advanced or metastatic non-small cell lung cancer","sponsor":"Pfizer","started":"2026-01-06","startedType":"actual","enrolled":1410,"enrolledBasis":"registry","outcomes":[]},{"id":"symbiotic-lung-04","kind":"trial","name":"Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer","aka":["Symbiotic-Lung-04"],"tldr":"A phase 2/3 trial testing PF-08634404 in non-small-cell lung cancer, now recruiting.","summary":"Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer is a phase 2/3 interventional study registered as NCT07226999, led by Pfizer, and recruiting on the registry. Official title: A global phase 2/3 interventional study of PF-08634404 in combination with chemotherapy in participants with extensive stage small cell lung cancer. Planned enrolment is 550 participants (estimated). The study started in 2025-12-09 and primary completion is expected in 2030-06-14. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07226999","url":"https://clinicaltrials.gov/study/NCT07226999"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-08634404"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07226999","phase":"2/3","setting":"A global phase 2/3 interventional study of PF-08634404 in combination with chemotherapy in participants with extensive stage small cell lung cancer","sponsor":"Pfizer","started":"2025-12-09","startedType":"actual","enrolled":550,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07489066","kind":"trial","name":"Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC","aka":["Symbiotic-Lung-10"],"tldr":"A phase 2 trial of PF-08634404 in non-small-cell lung cancer and small-cell lung cancer, run by Pfizer, now recruiting.","summary":"Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC is a phase 2 interventional study registered as NCT07489066 by Pfizer, with 120 participants planned, started 2026-06-30 and due to reach its primary completion in 2028-07-29. Interventions recorded: PF-08634404, Chemotherapy Regimen 1, Chemotherapy Regimen 2. Conditions listed: Carcinoma, Non-Small-Cell Lung, Lung Cancer (NSCLC), Lung Neoplasms. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07489066","url":"https://clinicaltrials.gov/study/NCT07489066"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-08634404"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07489066","phase":"2","setting":"AN INTERVENTIONAL, OPEN-LABEL, PHASE 2 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY OR IN COMBINATION IN ADULT PARTICIPANTS WITH EARLY-STAGE RESECTABLE OR LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER","sponsor":"Pfizer","started":"2026-06-30","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07476287","kind":"trial","name":"Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed","aka":["Symbiotic-Lung-14"],"tldr":"A phase 2 trial of PF-08634404 in small-cell lung cancer, run by Pfizer, now recruiting.","summary":"Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer is a phase 2 interventional study registered as NCT07476287 by Pfizer, with 40 participants planned, started 2026-07-02 and due to reach its primary completion in 2028-03-19. Interventions recorded: PF-08634404, Chemotherapy. Conditions listed: Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC ), Transformed Small Cell Lung Cancer, Lung Neoplasms. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07476287","url":"https://clinicaltrials.gov/study/NCT07476287"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-08634404"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07476287","phase":"2","setting":"A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER","sponsor":"Pfizer","started":"2026-07-02","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07227298","kind":"trial","name":"Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers","aka":["Symbiotic-Lung-20"],"tldr":"A phase 1/2 trial of PF-08634404, PF-08046054 in non-small-cell lung cancer and small-cell lung cancer, run by Pfizer, now recruiting.","summary":"Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers is a phase 1/2 interventional study registered as NCT07227298 by Pfizer, with 162 participants planned, started 2026-01-30 and due to reach its primary completion in 2029-03-08. Interventions recorded: PF-08634404, Sigvotatug Vedotin, PF-08046054/SGN-PDL1V. Conditions listed: Advanced/Metastatic Non-Small Cell Lung Cancer, Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07227298","url":"https://clinicaltrials.gov/study/NCT07227298"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["pf-08634404","pf-08046054"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07227298","phase":"1/2","setting":"AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS","sponsor":"Pfizer","started":"2026-01-30","startedType":"actual","enrolled":162,"enrolledBasis":"registry","outcomes":[]},{"id":"sympatico","kind":"trial","name":"SYMPATICO","aka":["PCYC-1143-CA"],"tldr":"SYMPATICO showed that adding the BCL2 blocker venetoclax to ibrutinib for people whose mantle cell lymphoma had returned kept the disease under control for about ten months longer than ibrutinib alone, and the combination also produced complete responses in most untreated patients with the hard-to-treat TP53 mutation.","summary":"SYMPATICO was a phase 3 trial by Pharmacyclics and Janssen in 366 patients. After a safety run-in that monitored tumour lysis syndrome, patients with relapsed or refractory mantle cell lymphoma were randomised double-blind to ibrutinib 560 mg daily with venetoclax (ramped to 400 mg) for two years or with placebo; a separate open-label arm gave the combination to treatment-naive patients with TP53-mutated disease. The primary endpoint of the randomised phase was investigator-assessed progression-free survival.\n\nIn the registry results, at a median time on study of 61.3 months, median progression-free survival was 31.9 months with ibrutinib-venetoclax against 22.1 months with ibrutinib-placebo (hazard ratio 0.629), and the complete response rate in the treatment-naive TP53-mutated arm was 69.2 percent. One tumour lysis syndrome event occurred in the run-in among patients at increased risk. The corpus's mantle cell lymphoma page lists a BTK inhibitor with or without venetoclax on this trial.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03112174","url":"https://clinicaltrials.gov/study/NCT03112174"},{"label":"ClinicalTrials.gov results","url":"https://clinicaltrials.gov/study/NCT03112174?tab=results"}],"tags":["soc-trials"],"related":[],"cancers":["mantle-cell-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ibrutinib","venetoclax"],"companies":["abbvie","johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03112174","phase":"3","setting":"Relapsed or refractory mantle cell lymphoma after one to five prior lines: ibrutinib with venetoclax or with placebo (double-blind), after a safety run-in for tumour lysis syndrome, plus an open-label treatment-naive arm of the combination in patients with TP53 mutation","sponsor":"Pharmacyclics LLC.","result":"Median progression-free survival 31.9 months with ibrutinib plus venetoclax against 22.1 months with ibrutinib plus placebo (hazard ratio 0.629, p 0.0024); complete response 69.2 percent in treatment-naive TP53-mutated disease.","started":"2017-06-19","startedType":"actual","yearReported":2025,"enrolled":366,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival, randomised phase (registry results)","primary":true,"unit":"months","arms":[{"name":"Ibrutinib + venetoclax","value":31.9,"note":"95% CI 22.8 to 54.5; median time on study 61.3 months"},{"name":"Ibrutinib + placebo","value":22.1,"note":"95% CI 16.5 to 29.5"}],"hr":0.629,"ci":[0.465,0.85],"p":"0.0024","source":"https://clinicaltrials.gov/study/NCT03112174?tab=results"},{"endpoint":"Complete response rate, treatment-naive TP53-mutated arm (registry results)","primary":true,"unit":"%","arms":[{"name":"Ibrutinib + venetoclax, open label","value":69.2,"note":"95% CI 57.8 to 79.2; median time on study 40.5 months"}],"source":"https://clinicaltrials.gov/study/NCT03112174?tab=results"},{"endpoint":"Tumour lysis syndrome events in the safety run-in (registry results)","unit":"participants","arms":[{"name":"Increased tumour lysis risk at baseline","n":15,"value":1},{"name":"Low tumour lysis risk at baseline","n":6,"value":0}],"source":"https://clinicaltrials.gov/study/NCT03112174?tab=results"}]},{"id":"synergy-custirsen","kind":"trial","name":"SYNERGY","aka":["SYNERGY","custirsen with first-line docetaxel"],"tldr":"Blocking the survival protein clusterin did not make chemotherapy work better for advanced prostate cancer.","summary":"SYNERGY randomised 1,022 men with chemotherapy-naive metastatic castration-resistant prostate cancer to docetaxel and prednisone with or without custirsen, an antisense oligonucleotide against the chaperone protein clusterin. Randomisation was stratified by opioid use for cancer-related pain and by radiographic evidence of progression.\n\nMedian overall survival was 23.4 months (95 percent confidence interval 20.9 to 24.8) with custirsen and 22.0 months (19.5 to 24.0) without, hazard ratio 0.93 (0.79 to 1.10, p=0.415).\n\nThe commonest grade 3 or worse events with custirsen against control were neutropenia (grade 3 in 13 against 6 percent, grade 4 in 20 against 15 percent), febrile neutropenia (grade 3 in 10 against 6 percent) and fatigue (grade 3 in 11 against 8 percent). Serious adverse events were reported for 214 of 501 men (43 percent) on custirsen and 181 of 499 (36 percent) on control, and adverse events were attributed to 23 and 24 deaths respectively.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01188187","url":"https://clinicaltrials.gov/study/NCT01188187"},{"label":"SYNERGY (Lancet Oncology 2017)","url":"https://doi.org/10.1016/S1470-2045(17)30168-7"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["antisense-sirna","cytotoxic-chemotherapy"],"targets":[],"drugs":["custirsen","docetaxel","prednisone"],"companies":["achieve-life-sciences"],"institutions":[],"pathways":[],"terms":["castration-resistance"],"trials":["affinity-custirsen","tax-327"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01188187","phase":"3","setting":"Metastatic castration-resistant prostate cancer with no previous chemotherapy, PSA above 5 and Karnofsky score 70 percent or higher: docetaxel 75 mg/m2 with prednisone 5 mg twice daily, with or without weekly custirsen 640 mg after three loading doses, with overall survival as the primary endpoint","sponsor":"OncoGenex Technologies","result":"Median overall survival 23.4 against 22.0 months (hazard ratio 0.93, 95 percent confidence interval 0.79 to 1.10, p=0.415): no benefit.","started":"2010-11","yearReported":2017,"enrolled":1022,"enrolledBasis":"randomised","enrolledNote":"1,022 men were enrolled at 134 study centres in 12 countries between 10 December 2010 and 7 November 2012.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Docetaxel, prednisone and custirsen","n":510,"value":23.4},{"name":"Docetaxel and prednisone","n":512,"value":22}],"hr":0.93,"ci":[0.79,1.1],"p":"0.415","source":"https://doi.org/10.1016/S1470-2045(17)30168-7"}],"replication":"AFFINITY tested the same drug with cabazitaxel after docetaxel in 635 men and also found no benefit."},{"id":"nct07254585","kind":"trial","name":"SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma","aka":[],"tldr":"A phase 2 trial of SYS6010 in head and neck squamous cell carcinoma, run by CSPC Megalith Biopharmaceutical Co.,Ltd., now recruiting.","summary":"SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma is a phase 2 interventional study registered as NCT07254585 by CSPC Megalith Biopharmaceutical Co.,Ltd., with 70 participants planned, started 2025-12-18 and due to reach its primary completion in 2026-06-30. Interventions recorded: SYS6010 injection, Enlonstobart injection. Conditions listed: Head and Neck Squamous Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07254585","url":"https://clinicaltrials.gov/study/NCT07254585"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["sys6010"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07254585","phase":"2","setting":"An Open-label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of SYS6010 Combined With Enlonstobart in the Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","sponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","started":"2025-12-18","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07633873","kind":"trial","name":"SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC（SYNST","aka":[],"tldr":"A phase 3 trial of tislelizumab, paclitaxel / nab-paclitaxel, cisplatin and carboplatin in lung cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd., not yet recruiting.","summary":"SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC（SYNSTAR 04） is a phase 3, randomised interventional study registered as NCT07633873 by CSPC Megalith Biopharmaceutical Co.,Ltd., with a registry enrolment figure of 500 participants, started 2026-06-02 and due to reach its primary completion in 2027-09-30. Interventions recorded: SYS6010 injection; Enlonstobart injection; Tislelizumab injection; Paclitaxel+Carboplatin or Pemetrexed + Cisplatin/Carboplatin. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Progression Free Survival (PFS) assessed by IRC. Lung eligibility wording from the registry: \"Participants with pathologically confirmed locally advanced or metastatic NSCLC\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07633873","url":"https://clinicaltrials.gov/study/NCT07633873"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["tislelizumab","paclitaxel","cisplatin","carboplatin"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07633873","phase":"3","setting":"An Open-label, Multicenter Randomized Phase III Study of SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy as First-Line Treatment for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC","sponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","started":"2026-06-02","startedType":"estimated","enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07442565","kind":"trial","name":"SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase III","aka":["SYNSTAR03"],"tldr":"A phase 3 trial of SYS6010 and docetaxel in lung cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd., not yet recruiting.","summary":"SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase III is a phase 3, randomised interventional study registered as NCT07442565 by CSPC Megalith Biopharmaceutical Co.,Ltd., with a registry enrolment figure of 506 participants, started 2026-03-10 and due to reach its primary completion in 2027-12-30. Interventions recorded: SYS6010; Docetaxel. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: PFS (Progression-Free Survival) assessed by IRC (Independent Review Committee) in the EGFR high-expression population.; OS (Overall Survival) in the overall population. Lung eligibility wording from the registry: \"Patients with pathologically confirmed locally advanced or metastatic EGFR wild-type non-squamous non-small cell lung cancer (nsq-NSCLC)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07442565","url":"https://clinicaltrials.gov/study/NCT07442565"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["sys6010","docetaxel"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07442565","phase":"3","setting":"A Randomized, Open-label, Multicenter Phase III Study Comparing SYS6010 With Docetaxel in Patients With Locally Advanced or Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer Who Have Failed Standard Therapy","sponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","started":"2026-03-10","startedType":"estimated","enrolled":506,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07472647","kind":"trial","name":"SYS6090 Combination Therapy in Advanced Lung Cancer","aka":[],"tldr":"A phase 1/2 trial of pemetrexed, paclitaxel / nab-paclitaxel, docetaxel, bevacizumab and other drugs in lung cancer, run by Shanghai JMT-Bio Inc., not yet recruiting.","summary":"SYS6090 Combination Therapy in Advanced Lung Cancer is a phase 1/2, interventional study registered as NCT07472647 by Shanghai JMT-Bio Inc., with a registry enrolment figure of 596 participants, started 2026-02-28 and due to reach its primary completion in 2029-02-28. Interventions recorded: SYS6090 + pemetrexed + platinum-based chemotherapy; SYS6090 + paclitaxel + platinum-based chemotherapy; SYS6090 + docetaxel; SYS6090 + pemetrexed + bevacizumab + platinum-based chemotherapy; SYS6090 + SYS6010; SYS6090 + etoposide + platinum-based chemotherapy; SYS6090 + chemotherapy or other anticancer therapy. Conditions listed: Non-Small Cell Lung Cancer; Small Cell Lung Cancer. Primary outcome: Dose-Limiting Toxicity (DLT) (Phase Ib); Adverse Events (AEs) (Phase Ib); Objective response rate (ORR) (Phase II). Lung eligibility wording from the registry: \"Histologically or cytologically confirmed unresectable locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) according to the AJCC/UICC Cancer Staging System, 8th edition, or extensive-stage small cell lung cancer (SCLC), not amenable to curative surgical res\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07472647","url":"https://clinicaltrials.gov/study/NCT07472647"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc","nsclc"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["pemetrexed","paclitaxel","docetaxel","bevacizumab","sys6010","etoposide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07472647","phase":"1/2","setting":"A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Efficacy of SYS6090 in Combination With Other Therapies in Participants With Advanced Lung Cancer","sponsor":"Shanghai JMT-Bio Inc.","started":"2026-02-28","startedType":"estimated","enrolled":596,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06681038","kind":"trial","name":"Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy for Colon Peritoneal Metastases (PIPOX02)","aka":["PIPOX02"],"tldr":"A phase 2 trial in colorectal cancer, run by Institut Cancerologie de l'Ouest, not yet recruiting.","summary":"Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy for Colon Peritoneal Metastases (PIPOX02) is a phase 2, randomised interventional study registered as NCT06681038 by Institut Cancerologie de l'Ouest, with a registry enrolment figure of 114 participants, started 2025-02 and due to reach its primary completion in 2029-08. Interventions recorded: Standard Medical Therapy; PIPAC. Conditions listed: Peritoneal Metastases from Colorectal Cancer. Primary outcome: Progression free survival (PFS) between the two groups. Colorectal eligibility wording from the registry: \"* Histopathologically confirmed colonic adenocarcinoma with synchronous or metachronous peritoneal metastasis (PM);\". Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06681038","url":"https://clinicaltrials.gov/study/NCT06681038"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["hipec"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06681038","phase":"2","setting":"Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Colon Peritoneal Metastases - a Multicentre Phase II Randomized Trial (PIPOX02)","sponsor":"Institut Cancerologie de l'Ouest","started":"2025-02","startedType":"estimated","enrolled":114,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02579564","kind":"trial","name":"Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients","aka":[],"tldr":"A phase 3 trial of Gemcitabine, Vinorelbine, Paclitaxel / nab-paclitaxel, Pemetrexed, H101 oncolytic adenovirus, Recombinant human endostatin and Cisplatin in Non-small-cell lung cancer, run by Xinqiao Hospital of Chongqing, with a status the registry has not verified recently.","summary":"Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients is a phase 3 interventional study registered as NCT02579564 by Xinqiao Hospital of Chongqing, with 134 participants planned, started 2016-10 and due to reach its primary completion in 2018-06. Interventions recorded: Gemcitabine, Vinorelbine, Paclitaxel, Pemetrexed, Oncorine, Endostar, Cisplatin. Conditions recorded: Malignant Hydrothorax, Non Small Cell Lung Cancer.\n\nLinked to the drug H101 oncolytic adenovirus because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02579564","url":"https://clinicaltrials.gov/study/NCT02579564"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["gemcitabine","vinorelbine","paclitaxel","pemetrexed","h101-oncolytic-adenovirus","recombinant-human-endostatin","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02579564","phase":"3","setting":"Systemic Chemotherapy Combined With Thoracic Cavity Perfusion of Recombinant Human Adenovirus Type 5 and Endostatin Injections Versus Cisplatin for Treatment Malignant Hydrothorax in Non Small Cell Lung Cancer (NSCLC) Patients: A Multi-center, Randomized, Controlled Clinical Trial","sponsor":"Xinqiao Hospital of Chongqing","started":"2016-10","enrolled":134,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02885753","kind":"trial","name":"Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal C","aka":["OSCAR"],"tldr":"A phase 3 trial of leucovorin (folinic acid), panitumumab, bevacizumab (glioblastoma use) and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by Federation Francophone de Cancerologie Digestive, now recruiting.","summary":"Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver is a phase 3, randomised interventional study registered as NCT02885753 by Federation Francophone de Cancerologie Digestive, with a registry enrolment figure of 348 participants, started 2016-12 and due to reach its primary completion in 2028-09. Interventions recorded: Oxaliplatin intravenous; 5 FU bolus; Folinic acid; Oxaliplatin intra-arteriel; Panitumumab; Bevacizumab; 5 FU continuous; Irinotecan. Conditions listed: Colorectal Neoplasms. Primary outcome: progression-free survival. Colorectal eligibility wording from the registry: \"* Histologically proven colorectal adenocarcinoma with hepatic metastasis(es)\". Sites: Belgium, France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02885753","url":"https://clinicaltrials.gov/study/NCT02885753"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["leucovorin","panitumumab","bevacizumab-glioma","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02885753","phase":"3","setting":"Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver","sponsor":"Federation Francophone de Cancerologie Digestive","started":"2016-12","startedType":"actual","enrolled":348,"enrolledBasis":"registry","outcomes":[]},{"id":"sysucc-001","kind":"trial","name":"SYSUCC-001","aka":[],"tldr":"SYSUCC-001 gave a year of low-dose daily capecitabine after standard chemotherapy for early triple-negative breast cancer in China. Fewer women relapsed at five years (83 versus 73 percent) and at ten years (78 versus 67 percent), but the improvement in survival itself did not reach statistical significance.","summary":"SYSUCC-001 (NCT01112826) randomised 443 women with early triple-negative breast cancer who had completed standard adjuvant chemotherapy at 13 Chinese centres between 2010 and 2016 to capecitabine 650 mg/m2 twice daily for one year without interruption or observation; 434 were analysed. At a median follow-up of 61 months (JAMA 2021) five-year disease-free survival was 82.8 versus 73.0 percent (hazard ratio 0.64, 95 percent confidence interval 0.42 to 0.95, p 0.03), distant disease-free survival 85.8 versus 75.8 percent (0.60) and overall survival 85.5 versus 81.3 percent (0.75, 0.47 to 1.19, p 0.22); hand-foot syndrome occurred in 45.2 percent (7.7 percent grade 3). The ten-year update (Lancet Oncology 2025, median 116 months) gave disease-free survival 78.1 versus 66.6 percent (hazard ratio 0.61, p 0.0074) and overall survival 82.4 versus 73.7 percent (0.67, 0.45 to 1.01, p 0.058); in an exploratory analysis FOXC1-high tumours (149 patients) had disease-free (0.33) and overall survival (0.25) benefit while FOXC1-low tumours had none. The population (93 percent T1 to T2, 62 percent node-negative, no neoadjuvant therapy or immunotherapy) is not the CREATE-X residual-disease population, and the regimen has not been adopted in Western guidelines.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01112826","url":"https://clinicaltrials.gov/study/NCT01112826"},{"label":"Wang et al., JAMA 2021: SYSUCC-001 primary results","url":"https://doi.org/10.1001/jama.2020.23370"},{"label":"SYSUCC-001 ten-year outcomes and FOXC1 analysis (Lancet Oncology 2025)","url":"https://doi.org/10.1016/S1470-2045(25)00545-5"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":["efs","hand-foot-syndrome"],"trials":["create-x","geicam-ciboma"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01112826","phase":"3","setting":"Operable early triple-negative breast cancer (T1b to T3, N0 to N3c) after standard adjuvant chemotherapy: one year of low-dose metronomic capecitabine 650 mg/m2 twice daily versus observation, 13 Chinese centres","sponsor":"Sun Yat-sen University Cancer Center","result":"5-year DFS 82.8% vs 73.0% (HR 0.64, p 0.03); 10-year DFS 78.1% vs 66.6% (HR 0.61); 10-year OS 82.4% vs 73.7% (HR 0.67, p 0.058).","started":"2010-04-23","startedType":"actual","yearReported":2021,"enrolled":443,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Metronomic capecitabine","n":221,"value":82.8},{"name":"Observation","n":213,"value":73}],"hr":0.64,"ci":[0.42,0.95],"p":"0.03","source":"https://doi.org/10.1001/jama.2020.23370"},{"endpoint":"Disease-free survival at 10 years","unit":"%","arms":[{"name":"Metronomic capecitabine","value":78.1},{"name":"Observation","value":66.6}],"hr":0.61,"ci":[0.43,0.88],"p":"0.0074","source":"https://doi.org/10.1016/S1470-2045(25)00545-5"},{"endpoint":"Overall survival at 10 years","unit":"%","arms":[{"name":"Metronomic capecitabine","value":82.4},{"name":"Observation","value":73.7}],"hr":0.67,"ci":[0.45,1.01],"p":"0.058","source":"https://doi.org/10.1016/S1470-2045(25)00545-5"}],"replication":"CREATE-X (residual disease) was positive for survival; GEICAM/CIBOMA (extended capecitabine, unselected early TNBC) was negative."},{"id":"nct06045767","kind":"trial","name":"T-Cell Repertoire Sequencing: Assessing Pembrolizumab Efficacy in Advanced Non-small Lung Cancer","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Ari Raphael, not yet recruiting.","summary":"T-Cell Repertoire Sequencing: Assessing Pembrolizumab Efficacy in Advanced Non-small Lung Cancer is a phase 2, interventional study registered as NCT06045767 by Ari Raphael, with a registry enrolment figure of 30 participants, started 2024-06 and due to reach its primary completion in 2029-01. Interventions recorded: Pembrolizumab 50 MG Injection [Keytruda]. Conditions listed: Non-small Cell Lung Cancer Metastatic. Primary outcome: Objective Response Rate (ORR) per RECIST 1.1 - correlated to TCR repertoire data, such as clonality/diversity.. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06045767","url":"https://clinicaltrials.gov/study/NCT06045767"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06045767","phase":"2","setting":"T-Cell Repertoire Sequencing: Assessing Pembrolizumab Efficacy in Advanced Non-small Lung Cancer","sponsor":"Ari Raphael","started":"2024-06","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06343311","kind":"trial","name":"T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)","aka":["STARLIGHT-1"],"tldr":"A phase 1/2 trial of EB103 in non-Hodgkin lymphoma, hodgkin lymphoma and diffuse large B-cell lymphoma, run by Estrella Biopharma, Inc., now recruiting.","summary":"T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) is a phase 1/2 interventional study registered as NCT06343311 by Estrella Biopharma, Inc., with 21 participants planned, started 2024-06-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: EB103.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06343311","url":"https://clinicaltrials.gov/study/NCT06343311"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","hodgkin-lymphoma","dlbcl"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06343311","phase":"1/2","setting":"An Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of EB103 T-Cell Therapy in Adults With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (NHL)","sponsor":"Estrella Biopharma, Inc.","started":"2024-06-01","startedType":"actual","enrolled":21,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02641847","kind":"trial","name":"TA(E)C-GP Versus A(E)C-T for the High Risk TNBC Patients and Validation of the mRNA-lncRNA Signature","aka":[],"tldr":"A phase 2/3 trial of docetaxel, doxorubicin, epirubicin, cyclophosphamide and other drugs in triple-negative breast cancer, run by Fudan University, active but no longer recruiting.","summary":"TA(E)C-GP Versus A(E)C-T for the High Risk TNBC Patients and Validation of the mRNA-lncRNA Signature is a phase 2/3, randomised interventional study registered as NCT02641847 by Fudan University, with a registry enrolment figure of 503 participants, started 2016-01 and due to reach its primary completion in 2023-12. Interventions recorded: docetaxel; doxorubicin or epirubicin; cyclophosphamide; gemcitabine; cisplatin. Conditions listed: Triple Negative Breast Cancer; Breast Cancer. Triple-negative eligibility wording from the registry: \"Triple negative breast cancer confirmed by pathology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02641847","url":"https://clinicaltrials.gov/study/NCT02641847"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["docetaxel","doxorubicin","epirubicin","cyclophosphamide","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02641847","phase":"2/3","setting":"Efficacy and Safety Study of TA(E)C-GP Versus A(E)C-T for the High Risk Triple-negative Breast Cancer Patients Predicted by the Messenger RNA (mRNA)-Long Non-coding RNA (lncRNA) Signature and Validation of the Signature's Efficacy","sponsor":"Fudan University","started":"2016-01","startedType":"actual","enrolled":503,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05862324","kind":"trial","name":"TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3)","aka":["TACTIC-3"],"tldr":"A phase 1/2 trial of TAC01-CLDN18.2 in advanced solid tumours, run by Triumvira Immunologics, Inc., active and no longer recruiting.","summary":"TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3) is a phase 1/2 interventional study registered as NCT05862324 by Triumvira Immunologics, Inc., with 113 participants enrolled, started 2023-08-23 and due to reach its primary completion in 2027-08-01. Interventions recorded: TAC01-CLDN18.2.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05862324","url":"https://clinicaltrials.gov/study/NCT05862324"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["tcr-t"],"targets":[],"drugs":["tac01-cldn18-2"],"companies":["triumvira-immunologics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05862324","phase":"1/2","setting":"A Phase 1/2 Study Investigating the Safety and Efficacy of Autologous TAC T Cells in Subjects With Unresectable, Locally Advanced or Metastatic Claudin 18.2+ Solid Tumors","sponsor":"Triumvira Immunologics, Inc.","started":"2023-08-23","startedType":"actual","enrolled":113,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05548127","kind":"trial","name":"TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A)","aka":["TACTIVE-U"],"tldr":"A phase 1/2 trial of Vepdegestrant and Abemaciclib in advanced solid tumours, run by Pfizer, active and no longer recruiting.","summary":"TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A) is a phase 1/2 interventional study registered as NCT05548127 by Pfizer, with 37 participants enrolled, started 2023-02-23 and due to reach its primary completion in 2027-03-24. Interventions recorded: ARV-471 and Abemaciclib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05548127","url":"https://clinicaltrials.gov/study/NCT05548127"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy","protac-degrader"],"targets":[],"drugs":["vepdegestrant","abemaciclib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05548127","phase":"1/2","setting":"TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY A (ARV-471 IN COMBINATION WITH ABEMACICLIB)","sponsor":"Pfizer","started":"2023-02-23","startedType":"actual","enrolled":37,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05573555","kind":"trial","name":"TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B)","aka":["TACTIVE-U"],"tldr":"A phase 1/2 trial of Vepdegestrant and Ribociclib in advanced solid tumours, run by Pfizer, active and no longer recruiting.","summary":"TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) is a phase 1/2 interventional study registered as NCT05573555 by Pfizer, with 20 participants enrolled, started 2023-03-01 and due to reach its primary completion in 2026-12-30. Interventions recorded: ARV-471 and Ribociclib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05573555","url":"https://clinicaltrials.gov/study/NCT05573555"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy","protac-degrader"],"targets":[],"drugs":["vepdegestrant","ribociclib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05573555","phase":"1/2","setting":"TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY B (ARV-471 IN COMBINATION WITH RIBOCICLIB)","sponsor":"Pfizer","started":"2023-03-01","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06125522","kind":"trial","name":"TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C)","aka":["TACTIVE-U"],"tldr":"A phase 1/2 trial of Vepdegestrant in advanced solid tumours, run by Pfizer, active and no longer recruiting.","summary":"TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C) is a phase 1/2 interventional study registered as NCT06125522 by Pfizer, with 11 participants enrolled, started 2024-01-10 and due to reach its primary completion in 2026-12-31. Interventions recorded: vepdegestrant and Samuraciclib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06125522","url":"https://clinicaltrials.gov/study/NCT06125522"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy","protac-degrader"],"targets":[],"drugs":["vepdegestrant","samuraciclib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06125522","phase":"1/2","setting":"TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY C (ARV-471 IN COMBINATION WITH SAMURACICLIB)","sponsor":"Pfizer","started":"2024-01-10","startedType":"actual","enrolled":11,"enrolledBasis":"registry","outcomes":[]},{"id":"tadpole","kind":"trial","name":"TADPOLE (CDRB436G2201)","aka":[],"tldr":"The first randomised trial to show that a targeted drug pair beats chemotherapy in children with a brain tumour. Children whose low-grade glioma carries a BRAF V600 mutation had far more tumour shrinkage and a much longer time before progression on dabrafenib plus trametinib than on standard carboplatin and vincristine.","summary":"Phase 2 randomised trial (Bouffet et al., NEJM 2023). 110 patients randomised (73 to dabrafenib plus trametinib, 37 to carboplatin plus vincristine). At a median follow-up of 18.9 months the independently assessed overall response rate was 47% versus 11% (risk ratio 4.31; 95% CI 1.7 to 11.2), clinical benefit 86% versus 46%, and median progression-free survival 20.1 versus 7.4 months (HR 0.31; 95% CI 0.17 to 0.55). Grade 3 or higher adverse events were less frequent with the targeted pair (47% versus 94%). Basis of the FDA approval of dabrafenib plus trametinib for paediatric BRAF V600E LGG in March 2023, with new liquid and dispersible formulations for young children. A separate cohort in relapsed BRAF V600 high-grade glioma also responded.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT02684058","url":"https://clinicaltrials.gov/study/NCT02684058"},{"label":"Bouffet et al., NEJM 2023","url":"https://doi.org/10.1056/NEJMoa2303815"}],"tags":["nci-coverage","paediatric","cns"],"related":[],"cancers":["paediatric-low-grade-glioma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["braf"],"drugs":["dabrafenib-trametinib","carboplatin","vincristine"],"companies":["novartis"],"institutions":[],"pathways":["ras-mapk"],"terms":["braf-v600-mutation","race-for-children-act"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-bouffet-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02684058","phase":"2","setting":"Newly diagnosed BRAF V600-mutant paediatric low-grade glioma needing systemic therapy: dabrafenib + trametinib vs carboplatin + vincristine (2:1 randomisation)","sponsor":"Novartis","result":"ORR 47% vs 11%; median PFS 20.1 vs 7.4 months, HR 0.31.","started":"2017-12-28","startedType":"actual","yearReported":2023,"enrolled":110,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 151 participants (actual) across the study's cohorts; the NEJM 2023 low-grade glioma analysis randomised 110 patients (73 dabrafenib plus trametinib, 37 chemotherapy).","outcomes":[{"endpoint":"Overall response rate (independent review, RANO)","primary":true,"unit":"%","arms":[{"name":"Dabrafenib + trametinib","n":73,"value":47},{"name":"Carboplatin + vincristine","n":37,"value":11}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa2303815"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Dabrafenib + trametinib","n":73,"value":20.1},{"name":"Carboplatin + vincristine","n":37,"value":7.4}],"hr":0.31,"ci":[0.17,0.55],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa2303815"}],"replication":"Consistent with earlier single-arm paediatric dabrafenib and trametinib studies; the only randomised comparison so far. FIREFLY-1 addressed the BRAF-fusion population that this trial excluded."},{"id":"nct07786428","kind":"trial","name":"Tailored Neoadjuvant Chemoimmunotherapy for Stage I TNBC","aka":["DETENTE-1"],"tldr":"A phase 2 trial of pembrolizumab, paclitaxel / nab-paclitaxel and carboplatin in triple-negative breast cancer, run by University of Texas Southwestern Medical Center, not yet recruiting.","summary":"Tailored Neoadjuvant Chemoimmunotherapy for Stage I TNBC is a phase 2, randomised interventional study registered as NCT07786428 by University of Texas Southwestern Medical Center, with a registry enrolment figure of 60 participants, started 2026-10-01 and due to reach its primary completion in 2029-10-31. Interventions recorded: Pembrolizumab; Paclitaxel (Chemotherapy); Carboplatin. Conditions listed: Triple-Negative Breast Cancer (TNBC). Triple-negative eligibility wording from the registry: \"* Must have histologically confirmed invasive triple negative breast cancer as defined by ER/PR \\<10% and HER2 negative by ASCO/CAP criteria or disease consistent with TNBC by physician assessment, with confirmation by study PI\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07786428","url":"https://clinicaltrials.gov/study/NCT07786428"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pembrolizumab","paclitaxel","carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07786428","phase":"2","setting":"A Phase 2 Randomized Pilot Study to Develop Tailored Neoadjuvant Chemoimmunotherapy Strategies in Stage I Triple-negative Breast Cancer (DETENTE-1)","sponsor":"University of Texas Southwestern Medical Center","started":"2026-10-01","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"tailorx","kind":"trial","name":"TAILORx","aka":[],"tldr":"Showed that most women with the commonest breast cancer can safely skip chemotherapy if a gene test says their risk is low or intermediate.","summary":"TAILORx, trial NCT00310180 sponsored by ECOG-ACRIN and the NCI and reported in 2018, showed that most women with the commonest breast cancer can safely skip chemotherapy if the Oncotype DX gene test puts their recurrence risk in the low or intermediate range. Among 6,711 women with HR-positive, HER2-negative, node-negative disease and mid-range scores, endocrine therapy alone was non-inferior to chemotherapy plus endocrine therapy on invasive disease-free survival, although women aged fifty or under with scores of sixteen to twenty-five derived some chemotherapy benefit, and the trial spared chemotherapy for roughly seventy percent of eligible patients worldwide. RxPONDER extended the finding to node-positive postmenopausal women, and whether the age effect reflects ovarian suppression rather than chemotherapy is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00310180","url":"https://clinicaltrials.gov/study/NCT00310180"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":["rna-seq"],"targets":[],"drugs":["oncotype-dx"],"companies":["ecog-acrin"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["kathy-albain","joseph-sparano"],"bottlenecks":[],"keyPapers":["paper-tailorx-nejm-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00310180","phase":"3","setting":"HR+/HER2-, node-negative early breast cancer with Oncotype DX recurrence score 11-25: endocrine therapy alone vs chemo-endocrine therapy","sponsor":"ECOG-ACRIN / NCI","result":"9-year iDFS 83.3% vs 84.3%; non-inferior.","started":"2006-04-07","startedType":"actual","yearReported":2018,"enrolled":10273,"enrolledBasis":"registry","outcomes":[{"endpoint":"Invasive disease-free survival at 9 years (RS 11-25)","primary":true,"unit":"%","arms":[{"name":"Endocrine therapy alone","n":3399,"value":83.3},{"name":"Chemo-endocrine therapy","n":3312,"value":84.3}],"hr":1.08,"ci":[0.94,1.24],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1804710"}],"replication":"RxPONDER extended the finding to 1-3 positive nodes in postmenopausal women; MINDACT (MammaPrint) reached a similar conclusion with a different assay."},{"id":"nct04129502","kind":"trial","name":"TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations","aka":[],"tldr":"A phase 3 trial of Mobocertinib, Pemetrexed, Cisplatin in non-small-cell lung cancer and small-cell lung cancer, run by Takeda, active and no longer recruiting.","summary":"TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations is a phase 3 interventional study registered as NCT04129502 by Takeda, with 354 participants enrolled, started 2020-01-10 and due to reach its primary completion in 2026-10-31. Interventions recorded: TAK-788, Pemetrexed, Cisplatin, Carboplatin. Conditions listed: Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC). No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04129502","url":"https://clinicaltrials.gov/study/NCT04129502"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["mobocertinib","pemetrexed","cisplatin","carboplatin"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04129502-j-clin-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04129502","phase":"3","setting":"A Randomized Phase 3 Multicenter Open-Label Study to Compare the Efficacy of TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations","sponsor":"Takeda","started":"2020-01-10","startedType":"actual","enrolled":354,"enrolledBasis":"registry","outcomes":[]},{"id":"takahashi-pci","kind":"trial","name":"Takahashi trial: prophylactic cranial irradiation with MRI surveillance in extensive-stage small-cell lung cancer","aka":[],"tldr":"When patients were checked with brain MRI first, prophylactic brain irradiation no longer lengthened survival in extensive-stage small-cell lung cancer, so many centres now offer MRI surveillance instead.","summary":"This Japanese trial randomised 224 patients with extensive-stage small-cell lung cancer, MRI-confirmed free of brain metastases after chemotherapy, to prophylactic cranial irradiation (25 Gy in ten fractions) or observation with regular MRI. Median overall survival was 11.6 months with irradiation and 13.7 months with observation (hazard ratio 1.27, not significant); brain metastases were fewer with irradiation but were caught early on surveillance and treated (Takahashi and colleagues, Lancet Oncology 2017). The trial stopped early for futility.","status":"negative","asOf":"2026-09-17","links":[{"label":"Lancet Oncology 2017","url":"https://doi.org/10.1016/S1470-2045(17)30230-9"}],"tags":["radiation-wave4"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["prophylactic-cranial-irradiation","mri"],"targets":[],"drugs":[],"companies":["wjog"],"institutions":[],"pathways":[],"terms":["wbrt"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-takahashi-lancet-oncol"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Extensive-stage small-cell lung cancer with no brain metastases on MRI after chemotherapy: prophylactic cranial irradiation versus MRI surveillance","sponsor":"West Japan Oncology Group","result":"Median overall survival 11.6 (PCI) vs 13.7 months (MRI surveillance), no benefit.","yearReported":2017,"enrolled":224,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Prophylactic cranial irradiation","n":113,"value":11.6},{"name":"Observation with MRI surveillance","n":111,"value":13.7}],"hr":1.27,"ci":[0.96,1.68],"p":"0.094","source":"https://doi.org/10.1016/S1470-2045(17)30230-9"}]},{"id":"talapro-2","kind":"trial","name":"TALAPRO-2","aka":[],"tldr":"The PARP-plus-hormone combination that eventually showed an overall survival benefit, in 2024-25.","summary":"TALAPRO-2, trial NCT03395197 sponsored by Pfizer and reported in 2023, is the PARP inhibitor plus hormone therapy combination that eventually showed an overall survival benefit, reported between 2024 and 2025. It randomised 805 unselected men with first-line metastatic castration-resistant prostate cancer to enzalutamide with talazoparib or placebo, met its primary radiographic progression-free survival endpoint with a larger effect in the homologous recombination repair-mutant cohort, and at the final analysis showed improved survival in both populations, though the 2023 FDA approval was limited to HRR-mutant disease. OnCo links it to BRCA1 and BRCA2 and PARP as targets, to talazoparib and enzalutamide. As the only such combination with a significant all-comer survival benefit, whether that finding widens the label is the open question.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT03395197","url":"https://clinicaltrials.gov/study/NCT03395197"},{"label":"NICE TA1130: talazoparib with enzalutamide for untreated hormone-relapsed metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta1130"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["parp-inhibitor"],"targets":["brca","parp"],"drugs":["talazoparib","enzalutamide"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":["prostate-hrr-eligibility","prostate-uk-drug-approvals"],"trials":["propel","magnitude"],"people":["neeraj-agarwal"],"bottlenecks":[],"keyPapers":["paper-talapro-2-lancet-2023","paper-talapro-2-lancet-2025-update"],"journals":[],"dependsOn":[],"notes":["In England NICE TA1130 recommends talazoparib with enzalutamide for untreated hormone-relapsed metastatic prostate cancer only when chemotherapy is not clinically indicated and abiraterone with prednisolone is either not tolerated or precluded by a clinical condition, and only with the companies' commercial arrangements. Treatment started before publication is not affected. Funding must be available in England within 90 days of publication."],"nct":"NCT03395197","phase":"3","setting":"First-line mCRPC: enzalutamide + talazoparib vs enzalutamide + placebo (all-comers and HRR-mutant cohorts)","sponsor":"Pfizer","result":"rPFS HR 0.63 (ITT); OS HR 0.80 (ITT), 0.62 (HRR-mutant).","started":"2017-12-18","startedType":"actual","yearReported":2023,"enrolled":805,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 1,054 participants (actual) across both cohorts; the Lancet 2023 primary analysis randomised 805 patients in the all-comers cohort (402 talazoparib, 403 placebo).","outcomes":[{"endpoint":"Radiographic progression-free survival, all comers","primary":true,"unit":"months","arms":[{"name":"Talazoparib + enzalutamide","n":402,"note":"Median not reached"},{"name":"Placebo + enzalutamide","n":403,"value":21.9}],"hr":0.63,"ci":[0.51,0.78],"p":"<0.0001","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01055-3/fulltext"},{"endpoint":"Overall survival, all comers (final)","unit":"months","arms":[{"name":"Talazoparib + enzalutamide","value":45.8},{"name":"Placebo + enzalutamide","value":37}],"hr":0.8,"ci":[0.66,0.96],"p":"0.016","source":"https://clinicaltrials.gov/study/NCT03395197"}],"replication":"Consistent with PROpel and MAGNITUDE; the only PARP + ARPI combination with a significant all-comer OS benefit."},{"id":"nct00002622","kind":"trial","name":"Talc in Treating Patients With Malignant Pleural Effusion","aka":[],"tldr":"A phase 3 trial of Talc in Metastatic cancer, run by Alliance for Clinical Trials in Oncology, completed.","summary":"Talc in Treating Patients With Malignant Pleural Effusion is a phase 3 interventional study registered as NCT00002622 by Alliance for Clinical Trials in Oncology, with 501 participants recorded, started 1994-12 and reaching its primary completion in 2005-03. Interventions recorded: talc, Talc. Conditions recorded: Metastatic Cancer.\n\nLinked to the drug Talc because the registry names it among its interventions and Metastatic cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00002622","url":"https://clinicaltrials.gov/study/NCT00002622"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["talc-sclerosant"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002622","phase":"3","setting":"Sclerosis of Pleural Effusions by Talc Thoracoscopy Versus Talc Slurry: A Phase III Study","sponsor":"Alliance for Clinical Trials in Oncology","started":"1994-12","enrolled":501,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04919811","kind":"trial","name":"Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC","aka":["TRUST-II"],"tldr":"A phase 2 trial of Taletrectinib in non-small-cell lung cancer and small-cell lung cancer, run by Nuvation Bio Inc., active and no longer recruiting.","summary":"Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC is a phase 2 interventional study registered as NCT04919811 by Nuvation Bio Inc., with 217 participants enrolled, started 2021-09-01 and due to reach its primary completion in 2025-06-11. Interventions recorded: Taletrectinib. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04919811","url":"https://clinicaltrials.gov/study/NCT04919811"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","ros1-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["taletrectinib"],"companies":["nuvation-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04919811","phase":"2","setting":"A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients With Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors","sponsor":"Nuvation Bio Inc.","started":"2021-09-01","startedType":"actual","enrolled":217,"enrolledBasis":"registry","outcomes":[]},{"id":"talicel-phase-1-2","kind":"trial","name":"Talicabtagene autoleucel (NexCAR19) phase 1/2","aka":[],"tldr":"The trial behind India's first CAR-T approval: about three in four heavily pretreated patients with lymphoma or leukaemia responded to a therapy made in Mumbai.","summary":"64 patients were enrolled (14 in the phase 1 dose escalation, 50 in phase 2) at six tertiary cancer centres; the phase 2 dose was at least 5 x 10^6 CAR-T cells per kg (up to 2 x 10^9). Among 51 efficacy-evaluable patients (36 B-cell lymphoma, 15 B-ALL) the overall response rate was 73% (37 of 51; 95% CI 59-83). Grade 3 or worse haematological toxicity was near universal (neutropenia 96%, thrombocytopenia 65%, anaemia 61%) and two deaths were treatment related (one febrile neutropenia with haemophagocytic lymphohistiocytosis and septic shock, one pulmonary bleed with multi-organ dysfunction and cytokine release syndrome). Published in Lancet Haematology in 2025 with a commentary on CAR-T in lower-income countries.","status":"positive","asOf":"2026-09-10","links":[{"label":"Jain et al., Lancet Haematology 2025","url":"https://doi.org/10.1016/S2352-3026(24)00377-6"}],"tags":[],"related":[],"cancers":["dlbcl","all-leukemia"],"sections":[],"technologies":["car-t","point-of-care-cell-manufacturing"],"targets":["cd19"],"drugs":["talicabtagene-autoleucel"],"companies":["immunoact"],"institutions":["tata-memorial","actrec","iit-bombay"],"pathways":[],"terms":["orr","crs"],"trials":[],"people":["jain-hasmukh","narula-gaurav","purwar-rahul"],"bottlenecks":["b-manufacturing-cell-therapy","b-global-access"],"keyPapers":["paper-jain-talicabtagene-lancet-haem-2025"],"journals":[],"dependsOn":[],"notes":[],"phase":"1/2","setting":"Relapsed or refractory B-cell lymphoma and B-cell acute lymphoblastic leukaemia, adults and adolescents, six Indian tertiary centres","sponsor":"ImmunoACT with Tata Memorial Centre","result":"ORR 73% (37 of 51) in relapsed or refractory B-cell malignancies; two treatment-related deaths.","yearReported":2025,"enrolled":64,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate","primary":true,"unit":"%","arms":[{"name":"Talicabtagene autoleucel","n":51,"value":73,"note":"95% CI 59-83"}],"source":"https://doi.org/10.1016/S2352-3026(24)00377-6"}]},{"id":"tam-01","kind":"trial","name":"TAM-01","aka":[],"tldr":"TAM-01 showed that a quarter of the usual tamoxifen dose, taken for three years, roughly halved the risk of a new or recurrent breast cancer after treatment for DCIS or other pre-invasive changes, with far fewer of the side effects that make women stop the full dose.","summary":"Tamoxifen at 20 mg daily prevents recurrence after ductal carcinoma in situ but hot flushes, endometrial cancer and thrombosis limit its use. TAM-01 was an Italian phase 3 trial that randomised 500 women with breast intraepithelial neoplasia (atypical ductal hyperplasia, lobular carcinoma in situ or oestrogen receptor-positive or unknown ductal carcinoma in situ) to tamoxifen 5 mg daily or placebo for three years. The primary endpoint was the incidence of invasive breast cancer or ductal carcinoma in situ.\n\nLow-dose tamoxifen roughly halved the rate of breast events, including contralateral cancers, with no significant excess of endometrial cancer or venous thrombosis and only a modest increase in hot flushes. The benefit persisted in longer follow-up. Low-dose tamoxifen is now offered as an alternative for women who cannot tolerate the standard dose.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01357772","url":"https://clinicaltrials.gov/study/NCT01357772"}],"tags":["subtype-trials"],"related":[],"cancers":["ductal-carcinoma-in-situ","breast-cancer"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["tamoxifen"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["andrea-decensi"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01357772","phase":"3","setting":"Breast intraepithelial neoplasia (atypical ductal hyperplasia, lobular carcinoma in situ or hormone-sensitive ductal carcinoma in situ) after surgery: low-dose tamoxifen 5 mg daily for three years against placebo","sponsor":"Andrea DeCensi, Galliera Hospital, Genoa","result":"Tamoxifen 5 mg daily for three years roughly halved breast cancer events compared with placebo with few serious adverse effects.","started":"2008-11-12","startedType":"actual","yearReported":2019,"enrolled":500,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06434064","kind":"trial","name":"Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of doxorubicin and tamoxifen in triple-negative breast cancer, run by Roswell Park Cancer Institute, now recruiting.","summary":"Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer is a phase 2, interventional study registered as NCT06434064 by Roswell Park Cancer Institute, with a registry enrolment figure of 30 participants, started 2026-03-03 and due to reach its primary completion in 2028-11-30. Interventions recorded: Biopsy; Biospecimen Collection; Computed Tomography; Echocardiography; Magnetic Resonance Imaging; Pegylated Liposomal Doxorubicin Hydrochloride; Tamoxifen. Conditions listed: Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Unresectable Triple-Negative Breast Carcinoma; Metastatic Triple-Negative Breast Carcinoma. Triple-negative eligibility wording from the registry: \"* Patients with pathologically confirmed metastatic triple negative breast cancer (ER ≤ 10%) that have been previously treated with at least 2 lines of therapy in the metastatic setting\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06434064","url":"https://clinicaltrials.gov/study/NCT06434064"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["doxorubicin","tamoxifen"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06434064","phase":"2","setting":"A Pilot, Single-Arm, Phase II Trial of Tamoxifen Plus Pegylated Liposomal Doxorubicin in Patients With Metastatic Triple Negative Breast Cancer","sponsor":"Roswell Park Cancer Institute","started":"2026-03-03","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06914674","kind":"trial","name":"Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas","aka":["SPTP"],"tldr":"A phase 2 trial in pancreatic cancer, run by Fudan University, now recruiting.","summary":"Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas is a phase 2, interventional study registered as NCT06914674 by Fudan University, with a registry enrolment figure of 30 participants, started 2025-03-20 and due to reach its primary completion in 2027-02-28. Interventions recorded: Tamoxifen 20 mg. Conditions listed: Pancreatic Neoplasms. Primary outcome: Progression-free survival (PFSn). Pancreatic eligibility wording from the registry: \", pancreatitis)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06914674","url":"https://clinicaltrials.gov/study/NCT06914674"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06914674","phase":"2","setting":"Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas","sponsor":"Fudan University","started":"2025-03-20","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"tappas","kind":"trial","name":"TAPPAS","aka":[],"tldr":"TAPPAS tested whether adding an antibody against endoglin, a protein on the abnormal blood vessel cells that make up angiosarcoma, would improve on the standard tablet pazopanib; it did not, and the trial was stopped for futility.","summary":"Angiosarcoma cells express endoglin (CD105), and TRC105 (carotuximab) is an antibody against it that had shown responses in combination with pazopanib in an earlier study. TAPPAS was an adaptive phase 3 trial randomising 123 patients with advanced angiosarcoma, cutaneous and non-cutaneous, to pazopanib with or without TRC105, with progression-free survival as the primary endpoint.\n\nAn interim analysis found no improvement in progression-free survival with the combination and the trial was stopped for futility. It remains one of the few randomised trials ever completed in angiosarcoma, and its control arm data on pazopanib are a reference for the disease.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02979899","url":"https://clinicaltrials.gov/study/NCT02979899"}],"tags":["subtype-trials"],"related":[],"cancers":["angiosarcoma","vascular-tumours","sarcoma"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["carotuximab","pazopanib"],"companies":["tracon"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["robin-jones"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02979899","phase":"3","setting":"Advanced angiosarcoma: pazopanib with or without the endoglin antibody TRC105 (carotuximab)","sponsor":"Tracon Pharmaceuticals","result":"Adding TRC105 to pazopanib did not improve progression-free survival; stopped for futility.","started":"2017-02-13","startedType":"actual","yearReported":2019,"enrolled":128,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (blinded independent review)","primary":true,"unit":"months","arms":[{"name":"Carotuximab (TRC105) + pazopanib","n":61,"value":4.2,"note":"114 evaluable of 123 randomised"},{"name":"Pazopanib alone","n":53,"value":4.3}],"hr":0.98,"ci":[0.52,1.84],"p":"0.95","source":"https://doi.org/10.1001/jamaoncol.2021.3547"},{"endpoint":"Epistaxis (all grades)","unit":"%","arms":[{"name":"Carotuximab (TRC105) + pazopanib","n":61,"value":56},{"name":"Pazopanib alone","n":53,"value":4}],"source":"https://doi.org/10.1001/jamaoncol.2021.3547"},{"endpoint":"Anaemia (all grades)","unit":"%","arms":[{"name":"Carotuximab (TRC105) + pazopanib","n":61,"value":44},{"name":"Pazopanib alone","n":53,"value":9}],"source":"https://doi.org/10.1001/jamaoncol.2021.3547"}]},{"id":"tapur","kind":"trial","name":"TAPUR (Targeted Agent and Profiling Utilization Registry)","aka":["TAPUR Study","ASCO TAPUR"],"tldr":"TAPUR is the American oncology society's own trial: when a genomic test finds a change that an already approved drug targets in a different cancer, the drug's maker supplies it free and the outcome is recorded. It turns off-label guesses into organised evidence, and has told the field which matches work and which do not.","summary":"TAPUR opened in March 2016 as the first clinical trial run by the American Society of Clinical Oncology. Oncologists at more than a hundred community and academic sites order genomic testing as they normally would; if a patient's tumour has an alteration that one of the participating companies' approved drugs targets, and the match is on the protocol's list or is approved by a molecular tumour board, the patient receives the drug at no cost and is followed for response, progression and toxicity. Drugs have come from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Genentech, Lilly, Merck, Pfizer, Seagen and Taiho, including pembrolizumab, nivolumab with ipilimumab, palbociclib, trastuzumab with pertuzumab, cetuximab, olaparib, talazoparib, vemurafenib with cobimetinib, sunitinib, axitinib, regorafenib, dasatinib, bosutinib, crizotinib and erlotinib. Each drug-by-tumour cohort follows a two-stage design: ten patients, expanding to 28 if enough show benefit.\n\nCohorts report continuously in JCO Precision Oncology and the Journal of Clinical Oncology. Positive cohorts include pembrolizumab in breast and other cancers with high tumour mutational burden, trastuzumab plus pertuzumab in colorectal cancer with ERBB2 amplification, and several immunotherapy cohorts; negative cohorts include palbociclib in non-small-cell lung cancer with CDKN2A loss, and cohorts of cetuximab, temsirolimus and other drugs where the target proved a poor predictor. A 2024 analysis reported high agreement between the trial's molecular tumour board reviewers, evidence that curated matching can be standardised.\n\nWhat TAPUR changed is the treatment of off-label targeted therapy as data rather than anecdote, at a cost far below a conventional trial, and it seeded sister programmes: the Netherlands' DRUP (2016) and Canada's CAPTUR use the same design and share results. What remains open is whether TAPUR-style evidence, which lacks a control arm, can support label changes or reimbursement; so far it has informed guidelines and directed drug companies toward or away from confirmatory trials.","status":"recruiting","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02693535","url":"https://clinicaltrials.gov/study/NCT02693535"},{"label":"ASCO: TAPUR Study","url":"https://www.tapur.org"},{"label":"Gupta et al., JCO Precision Oncology 2022: pertuzumab plus trastuzumab in colorectal cancer with ERBB2 amplification or ERBB2/3 mutations (TAPUR)","url":"https://doi.org/10.1200/PO.22.00306"},{"label":"Ahn et al., JCO Precision Oncology 2020: palbociclib in non-small-cell lung cancer with CDKN2A alterations (TAPUR)","url":"https://doi.org/10.1200/PO.20.00037"},{"label":"Concordance in molecular tumor board case reviews in the ASCO TAPUR study, JCO Precision Oncology 2024","url":"https://doi.org/10.1200/PO.23.00615"}],"tags":[],"related":[],"cancers":["rare-cancers","colorectal","nsclc","breast-cancer"],"sections":[],"technologies":["cgp","variant-knowledgebases","checkpoint-inhibitor","cdk46-inhibitor","parp-inhibitor"],"targets":[],"drugs":["pembrolizumab","nivolumab","ipilimumab","palbociclib","trastuzumab","pertuzumab","cetuximab","olaparib","talazoparib","vemurafenib","cobimetinib","sunitinib","axitinib","regorafenib","dasatinib","bosutinib","crizotinib","erlotinib"],"companies":["astrazeneca","bayer","boehringer-ingelheim","bms","roche-genentech","eli-lilly","merck","pfizer","taiho"],"institutions":["asco"],"pathways":[],"terms":["master-protocol","basket-umbrella-platform","tumour-agnostic","tmb","real-world-evidence"],"trials":[],"people":[],"bottlenecks":["b-rare-cancers","b-trial-design"],"keyPapers":["paper-ahn-jco-precis-oncol","paper-gupta-jco-precis-oncol","paper-perez-jco-precis-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02693535","phase":"2","setting":"Advanced solid tumours, multiple myeloma and B-cell lymphoma with a genomic alteration that an approved targeted drug addresses in another cancer: the drug is given off-label in a pragmatic basket with cohorts by drug and tumour type","sponsor":"American Society of Clinical Oncology","result":"Continuous cohort reporting: positive signals for pembrolizumab in high tumour mutational burden cancers and trastuzumab plus pertuzumab in ERBB2-amplified colorectal cancer; palbociclib in CDKN2A-altered lung cancer and several other matches were negative.","started":"2016-03-14","startedType":"actual","yearReported":2020,"enrolledBasis":"registry","outcomes":[]},{"id":"target-national","kind":"trial","name":"TARGET National","aka":["TARGET","Tumour Characterisation to Guide Experimental Targeted Therapy","TARGET trial Manchester"],"tldr":"TARGET National is the United Kingdom's programme to sequence the blood and tumour of thousands of people with advanced cancer so they can be steered into early trials of drugs that fit their tumour's changes. It grew out of a Manchester pilot that showed a blood test alone could find a trial for one patient in ten.","summary":"TARGET began at the Christie and the Cancer Research UK Manchester Institute, led by Matthew Krebs and Caroline Dive, as a single-centre study of whether circulating tumour DNA could support selection for phase 1 trials. The 2019 Nature Medicine report on the first 100 patients found that a 641-gene plasma panel and tissue sequencing together identified an actionable alteration in 41 patients and matched 11 of them to a phase 1 trial, and that plasma and tissue results agreed well when circulating tumour DNA was abundant.\n\nTARGET National opened in June 2021 with Cancer Research UK funding and a target of 6,000 patients recruited through experimental cancer medicine centres across the country. Every participant has blood and, where available, tissue sequenced, results are reviewed by a national molecular tumour board and matched to open early-phase trials, and the linked clinical and genomic data build a research resource on how advanced cancers evolve under treatment. It is observational: the trials patients enter are separate studies.\n\nThe programme's contribution is logistics rather than a drug result: a common national pipeline from blood draw to trial slot, faster than the tissue-based screening of the National Lung Matrix Trial, and a cohort that DETERMINE and other United Kingdom platforms can draw on. What remains to be shown is how many screened patients actually reach a matched trial, and whether the pipeline shortens the time from progression to experimental treatment enough to change outcomes.","status":"recruiting","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04723316","url":"https://clinicaltrials.gov/study/NCT04723316"},{"label":"Rothwell et al., Nature Medicine 2019: utility of ctDNA to support patient selection for early phase clinical trials, the TARGET study","url":"https://doi.org/10.1038/s41591-019-0380-z"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["liquid-biopsy","cgp","variant-knowledgebases","ai-trial-matching"],"targets":[],"drugs":[],"companies":[],"institutions":["the-christie","cruk-manchester-institute","cruk"],"pathways":[],"terms":["master-protocol","ctdna","first-in-human"],"trials":["determine-trial"],"people":["caroline-dive"],"bottlenecks":["b-trial-enrolment"],"keyPapers":["paper-rothwell-nat-med"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04723316","phase":"observational","setting":"Adults with advanced solid cancers being considered for early-phase trials across the United Kingdom: circulating tumour DNA and tissue sequencing to match patients to experimental treatments and to build a national genomic cohort","sponsor":"The Christie NHS Foundation Trust, funded by Cancer Research UK","result":"Recruiting toward 6,000 patients; the Manchester pilot matched 11 of the first 100 patients to a phase 1 trial from combined plasma and tissue sequencing.","started":"2021-06-30","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"nct04183712","kind":"trial","name":"Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA","aka":[],"tldr":"A phase 2 trial of gemcitabine, oxaliplatin and afatinib in gallbladder cancer, run by Shanghai Jiao Tong University School of Medicine, now recruiting.","summary":"Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA is a phase 2, randomised interventional study registered as NCT04183712 by Shanghai Jiao Tong University School of Medicine, with a registry enrolment figure of 102 participants, started 2020-06-01 and due to reach its primary completion in 2025-06. Interventions recorded: gemcitabine and oxaliplatin., Afatinib. Conditions listed: Gallbladder Carcinoma. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04183712","url":"https://clinicaltrials.gov/study/NCT04183712"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","kinase-inhibitors"],"targets":[],"drugs":["gemcitabine","oxaliplatin","afatinib"],"companies":[],"institutions":[],"pathways":[],"terms":["ctdna"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04183712","phase":"2","setting":"A Multicentre, Open-label, Randomised, Controlled Study of Target Therapy Based on Tumor Molecular Profiling With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA.","sponsor":"Shanghai Jiao Tong University School of Medicine","started":"2020-06-01","startedType":"actual","enrolled":102,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07598955","kind":"trial","name":"Target-Selected CAR-NK Cells (CD30, CD5, or Mesothelin) for Relapsed/Refractory B2 Thymoma or Thymic Carcinoma","aka":["SELECT-NK-THYM"],"tldr":"A phase 1/2 trial of Cyclophosphamide, Fludarabine and EB-CAR30-NK in thymoma and thymic carcinoma, run by Beijing Biotech, now recruiting.","summary":"Target-Selected CAR-NK Cells (CD30, CD5, or Mesothelin) for Relapsed/Refractory B2 Thymoma or Thymic Carcinoma is a phase 1/2 interventional study registered as NCT07598955 by Beijing Biotech, with 36 participants planned, started 2026-03-02 and due to reach its primary completion in 2027-06-14. Interventions recorded: Cyclophosphamide, Fludarabine, EB-CAR30-NK, EB-CAR5-NK, EB-CARMSLN-NK and Rimiducid (AP1903).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07598955","url":"https://clinicaltrials.gov/study/NCT07598955"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["thymic-epithelial","thymoma","thymic-carcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["cyclophosphamide","fludarabine","eb-car30-nk"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07598955","phase":"1/2","setting":"A Phase 1/2, Open-Label, Target-Selected Study of Allogeneic CAR-NK Cells Directed to CD30, CD5, or Mesothelin in Patients With Relapsed/Refractory B2 Thymoma or Thymic Carcinoma","sponsor":"Beijing Biotech","started":"2026-03-02","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05219500","kind":"trial","name":"Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate Cancer (TATCIST).","aka":["TATCIST"],"tldr":"A phase 2 trial of FPI-2265 in prostate cancer, run by Fusion Pharmaceuticals Inc., active and no longer recruiting.","summary":"Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate Cancer (TATCIST). is a phase 2 interventional study registered as NCT05219500 by Fusion Pharmaceuticals Inc., with 115 participants planned, started 2021-12-16 and due to reach its primary completion in 2025-05-30. Interventions recorded: FPI-2265. Conditions listed: Metastatic Castration Resistant Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05219500","url":"https://clinicaltrials.gov/study/NCT05219500"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["fpi-2265"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05219500","phase":"2","setting":"PSMA-directed Targeted Alpha Therapy With FPI-2265 (225Ac-PSMA-I&T) for the Treatment of Metastatic Castration-resISTant Prostate Cancer (TATCIST). A Phase II Clinical Trial.","sponsor":"Fusion Pharmaceuticals Inc.","started":"2021-12-16","startedType":"actual","enrolled":115,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05636618","kind":"trial","name":"Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors","aka":[],"tldr":"A phase 1/2 trial of [203Pb]VMT-α-NET in neuroendocrine tumours, pancreatic ductal adenocarcinoma and pheochromocytoma and paraganglioma, run by Perspective Therapeutics, now recruiting.","summary":"Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors is a phase 1/2 interventional study registered as NCT05636618 by Perspective Therapeutics, with 300 participants planned, started 2023-09-27 and due to reach its primary completion in 2029-11-26. Interventions recorded: [203Pb]VMT-α-NET and [212Pb]VMT-α-NET.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05636618","url":"https://clinicaltrials.gov/study/NCT05636618"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine","pancreatic","pheochromocytoma-paraganglioma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["perspective-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05636618","phase":"1/2","setting":"A Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors","sponsor":"Perspective Therapeutics","started":"2023-09-27","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"targeted-axillary-dissection-md-anderson","kind":"trial","name":"Targeted axillary dissection (MD Anderson prospective study)","aka":["TAD study","clipped node study"],"tldr":"The fix for the problem Z1071 exposed. If the surgeon puts a marker in the lymph node that was biopsied at diagnosis and then goes back for that exact node after chemotherapy, the chance of missing leftover cancer falls from about one in ten to about one in fifty.","summary":"This prospective study enrolled 208 patients with biopsy-confirmed nodal metastases in whom a clip had been placed in the sampled node before treatment. After chemotherapy they had axillary surgery, and the pathology of the clipped node was compared with the rest. 191 went on to completion axillary clearance, and 120 of those (63 percent) had residual disease, so the false-negative rate could be measured.\n\nThe clipped node alone showed metastases in 115 patients, a false-negative rate of 4.2 percent (95 percent confidence interval 1.4 to 9.5). Sentinel node dissection alone, in the 118 patients who had both, gave 10.1 percent (4.2 to 19.8). Adding evaluation of the clipped node to sentinel node dissection brought it to 1.4 percent (0.03 to 7.3, p=0.03). In 85 patients who had formal targeted axillary dissection followed by clearance, the false-negative rate was 2.0 percent (one of fifty, 0.05 to 10.7).\n\nThe finding that explains why the technique is necessary is buried in the middle of the paper: the clipped node was not retrieved as a sentinel node in 23 percent of patients, 31 of 134, and six of those had negative sentinel nodes but metastasis in the clipped node. The node that was known to contain cancer is often not the node the tracer finds.","status":"positive","asOf":"2026-09-25","links":[{"label":"Targeted axillary dissection (Journal of Clinical Oncology 2016)","url":"https://doi.org/10.1200/JCO.2015.64.0094"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["sentinel-node","fluorescence-guided-surgery"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["targeted-axillary-dissection","sentinel-lymph-node-biopsy","neoadjuvant-versus-adjuvant-breast"],"trials":["acosog-z1071","atnec"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"observational","setting":"Biopsy-confirmed node-positive breast cancer with a clip placed in the sampled node before chemotherapy: selective removal of the clipped node alongside sentinel node dissection, checked against completion axillary clearance","sponsor":"University of Texas MD Anderson Cancer Center","result":"Adding the clipped node to sentinel node dissection cut the false-negative rate from 10.1 to 1.4 percent (p=0.03); targeted axillary dissection gave 2.0 percent.","yearReported":2016,"enrolled":208,"enrolledBasis":"registry","outcomes":[{"endpoint":"False-negative rate after chemotherapy","primary":true,"unit":"%","arms":[{"name":"Sentinel node dissection alone","n":118,"value":10.1,"note":"95 percent confidence interval 4.2 to 19.8"},{"name":"Sentinel node dissection plus the clipped node","n":118,"value":1.4,"note":"95 percent confidence interval 0.03 to 7.3"},{"name":"Targeted axillary dissection","n":85,"value":2,"note":"one of fifty, 95 percent confidence interval 0.05 to 10.7"}],"p":"0.03","source":"https://doi.org/10.1200/JCO.2015.64.0094"}],"replication":"Dual-tracer mapping with a minimum of three sentinel nodes reaches a similar false-negative rate in the Z1071 and SENTINA datasets; ATNEC is testing what to do when targeted axillary dissection is clear."},{"id":"targit-a","kind":"trial","name":"TARGIT-A (targeted intraoperative radiotherapy)","aka":["TARGIT-A trial","TARGIT-IORT","Intrabeam trial"],"tldr":"One dose of radiotherapy given inside the breast while the patient is still asleep, instead of three to six weeks of daily hospital visits. Cancer control was close enough to count as equivalent, slightly more cancers came back in the breast, and fewer women died of causes other than breast cancer.","summary":"TARGIT-A randomised 2,298 women aged 45 or over with invasive ductal carcinoma up to 3.5 cm at 32 centres in ten countries between 2000 and 2012, before lumpectomy, to risk-adapted targeted intraoperative radiotherapy or to external beam radiotherapy. Intraoperative treatment was delivered immediately after the lumpectomy under the same anaesthetic and was the only radiotherapy about 80 percent of those patients received; the remaining fifth had external beam treatment added when postoperative pathology found unsuspected higher-risk features.\n\nThe trial met its non-inferiority margin of 2.5 percent: local recurrence risk at five years with complete follow-up was 2.11 percent with intraoperative treatment against 0.95 percent with external beam, a difference of 1.16 percent (90 percent confidence interval 0.32 to 1.99). In the first five years there were thirteen more local recurrences (24 of 1,140 against 11 of 1,158) and fourteen fewer deaths (42 against 56).\n\nAt a median 8.6 years, nothing separated the arms on local recurrence-free survival (hazard ratio 1.13, 95 percent confidence interval 0.91 to 1.41, p=0.28), mastectomy-free survival (0.96, 0.78 to 1.19, p=0.74), distant disease-free survival (0.88, 0.69 to 1.12, p=0.30), overall survival (0.82, 0.63 to 1.05, p=0.13) or breast cancer mortality (1.12, 0.78 to 1.60, p=0.54). One endpoint did separate them: mortality from other causes was lower with intraoperative treatment (0.59, 0.40 to 0.86, p=0.005), which the investigators attribute to sparing the heart and lung.\n\nEngland did not adopt it. NICE TA501, published on 31 January 2018, recommends that the Intrabeam system is not used for routine commissioning, and permits it only on machines already installed and under NHS England clinical governance and data collection arrangements. The record is marked mixed because the trial met its own margin while the regulator that read it declined to fund the device.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00983684","url":"https://clinicaltrials.gov/study/NCT00983684"},{"label":"ISRCTN34086741","url":"https://www.isrctn.com/ISRCTN34086741"},{"label":"TARGIT-A long-term results (BMJ 2020)","url":"https://doi.org/10.1136/bmj.m2836"},{"label":"NICE TA501: Intrabeam radiotherapy system, not recommended for routine commissioning","url":"https://www.nice.org.uk/guidance/ta501"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":["intraoperative-radiotherapy","imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":["uclh"],"pathways":[],"terms":["partial-breast-irradiation","lumpectomy"],"trials":["rapid","import-low","nsabp-b39"],"people":[],"bottlenecks":[],"keyPapers":["paper-vaidya-bmj"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00983684","phase":"3","setting":"Women aged 45 or over with invasive ductal carcinoma up to 3.5 cm, cN0 to cN1, eligible for breast conservation: a single dose of targeted intraoperative radiotherapy given during lumpectomy, with external beam radiotherapy added where pathology found higher risk, against a standard course of whole-breast external beam radiotherapy","sponsor":"University College London","result":"Five-year local recurrence 2.11 percent with single-dose intraoperative radiotherapy against 0.95 percent with external beam, meeting the 2.5 percent non-inferiority margin; at a median 8.6 years no difference in survival, and mortality from other causes lower (hazard ratio 0.59, 0.40 to 0.86).","started":"2000-03","yearReported":2020,"enrolled":2298,"enrolledBasis":"randomised","enrolledNote":"2,298 women were randomised in the pre-pathology stratum reported in 2020; the ClinicalTrials.gov record NCT00983684 gives a registered total of 3,451 across both strata of the trial programme.","outcomes":[{"endpoint":"Local recurrence at 5 years","primary":true,"unit":"%","arms":[{"name":"Targeted intraoperative radiotherapy","n":1140,"value":2.11,"note":"absolute difference against external beam 1.16 percent, 90 percent confidence interval 0.32 to 1.99, within the 2.5 percent non-inferiority margin"},{"name":"External beam radiotherapy","n":1158,"value":0.95}],"source":"https://doi.org/10.1136/bmj.m2836"},{"endpoint":"Overall survival, long-term follow-up (median 8.6 years)","unit":"hazard ratio","arms":[{"name":"Targeted intraoperative radiotherapy against external beam","value":0.82}],"hr":0.82,"ci":[0.63,1.05],"p":"0.13","source":"https://doi.org/10.1136/bmj.m2836"},{"endpoint":"Mortality from causes other than breast cancer","unit":"hazard ratio","arms":[{"name":"Targeted intraoperative radiotherapy against external beam","value":0.59}],"hr":0.59,"ci":[0.4,0.86],"p":"0.005","source":"https://doi.org/10.1136/bmj.m2836"}]},{"id":"nct07637513","kind":"trial","name":"Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer","aka":["PrE0512"],"tldr":"A phase 3 trial of tarlatamab and durvalumab in lung cancer, run by PrECOG, LLC., not yet recruiting.","summary":"Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT07637513 by PrECOG, LLC., with a registry enrolment figure of 430 participants, started 2027-01 and due to reach its primary completion in 2037-11. Interventions recorded: Tarlatamab; Durvalumab. Conditions listed: Limited Stage Small-Cell Lung Cancer. Primary outcome: This phase III study has dual primary endpoints of progression-free survival (PFS) and overall survival (OS).; This phase III study has dual primary endpoints of progression-free survival (PFS) and overall survival (OS).. Lung eligibility wording from the registry: \"* Patient must have histologically or cytologically confirmed Small Cell Lung Cancer (SCLC)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07637513","url":"https://clinicaltrials.gov/study/NCT07637513"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["limited-stage-sclc"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor","t-cell-engager"],"targets":[],"drugs":["tarlatamab","durvalumab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07637513","phase":"3","setting":"Phase III Trial of Consolidation Tarlatamab + Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer (LS-SCLC)","sponsor":"PrECOG, LLC.","started":"2027-01","startedType":"estimated","enrolled":430,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07423585","kind":"trial","name":"Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of tarlatamab in lung cancer, run by Asrar Alahmadi, now recruiting.","summary":"Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer is a phase 2, interventional study registered as NCT07423585 by Asrar Alahmadi, with a registry enrolment figure of 39 participants, started 2026-03-20 and due to reach its primary completion in 2027-12-31. Interventions recorded: Biopsy Procedure; Biospecimen Collection; Computed Tomography; Echocardiography Test; Electronic Health Record Review; Magnetic Resonance Imaging; Multigated Acquisition Scan; Questionnaire Administration; Tarlatamab. Conditions listed: Extensive Stage Lung Small Cell Carcinoma. Primary outcome: 6-month progression-free survival (PFS); Rapid progressive disease (PD) on tarlatamab rate probability (Interim analysis for futility monitoring). Lung eligibility wording from the registry: \", metastatic and/or recurrent) SCLC\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07423585","url":"https://clinicaltrials.gov/study/NCT07423585"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["bispecific-antibody","t-cell-engager"],"targets":[],"drugs":["tarlatamab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07423585","phase":"2","setting":"A Front-Line Window-of-Opportunity Phase 2 Study of Tarlatamab (Bispecific T Cell Engager: DLL3-CD3) in Patients With Extensive-Stage Small-Cell Lung Cancer","sponsor":"Asrar Alahmadi","started":"2026-03-20","startedType":"actual","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06293014","kind":"trial","name":"TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of trifluridine/tipiracil and bevacizumab (glioblastoma use) in colorectal cancer, run by Henan Cancer Hospital, now recruiting.","summary":"TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer is a phase 2, randomised interventional study registered as NCT06293014 by Henan Cancer Hospital, with a registry enrolment figure of 224 participants, started 2024-02-23 and due to reach its primary completion in 2025-10-15. Interventions recorded: TAS-102+bevacizumab; Standard chemotherapy+bevacizumab. Conditions listed: Colorectal Cancer. Primary outcome: Time to treatment failure (TTF). Colorectal eligibility wording from the registry: \"Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06293014","url":"https://clinicaltrials.gov/study/NCT06293014"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["trifluridine-tipiracil","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06293014","phase":"2","setting":"A Randomized, Open-label, Multicentre Clinical Study of TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer","sponsor":"Henan Cancer Hospital","started":"2024-02-23","startedType":"actual","enrolled":224,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05343013","kind":"trial","name":"TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy","aka":[],"tldr":"A phase 2 trial of trifluridine/tipiracil in colorectal cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy is a phase 2, interventional study registered as NCT05343013 by M.D. Anderson Cancer Center, with a registry enrolment figure of 25 participants, started 2022-06-06 and due to reach its primary completion in 2027-05-15. Interventions recorded: TAS-102. Conditions listed: Colorectal Cancer. Primary outcome: To determine the 6-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy.. Colorectal eligibility wording from the registry: \"Has histological confirmation of colorectal cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05343013","url":"https://clinicaltrials.gov/study/NCT05343013"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","mrd-testing"],"targets":[],"drugs":["trifluridine-tipiracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05343013","phase":"2","setting":"TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy","sponsor":"M.D. Anderson Cancer Center","started":"2022-06-06","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04701476","kind":"trial","name":"TATE and Pembrolizumab (MK3475) in mCRC and NSCLC","aka":[],"tldr":"A phase 2 trial of Pembrolizumab, Trifluridine/tipiracil, Regorafenib in colorectal cancer, run by Teclison Ltd., now recruiting.","summary":"TATE and Pembrolizumab (MK3475) in mCRC and NSCLC is a phase 2 interventional study registered as NCT04701476 by Teclison Ltd., with 110 participants planned, started 2021-05-20 and due to reach its primary completion in 2027-03-31. Interventions recorded: TATE and pembrolizumab, TAS-102 pill, Regorafenib Pill. Conditions listed: Colorectal Cancer; Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04701476","url":"https://clinicaltrials.gov/study/NCT04701476"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","trifluridine-tipiracil","regorafenib"],"companies":["teclison"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04701476","phase":"2","setting":"An Open Label Phase II Study for the Treatment of Liver Metastatic Colorectal Cancer and Non-Small Cell Lung Cancer With a Combination of TATE (Trans-Arterial Tirapazamine Embolization) and Pembrolizumab","sponsor":"Teclison Ltd.","started":"2021-05-20","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"tax-327","kind":"trial","name":"TAX 327","aka":["TAX327","TAX 327 study"],"tldr":"The trial that first showed any drug could make men with hormone-resistant prostate cancer live longer. The gain was about two and a half months, and it also reduced pain.","summary":"Before TAX 327 no treatment had been shown to prolong life in hormone-refractory prostate cancer. Mitoxantrone with prednisone was the standard because it relieved pain, not because it worked.\n\nTAX 327 randomised 1,006 men to three-weekly mitoxantrone, three-weekly docetaxel or weekly docetaxel, all with prednisone. Against mitoxantrone, three-weekly docetaxel gave a hazard ratio for death of 0.76 (95 percent confidence interval 0.62 to 0.94, p=0.009 by stratified log-rank) and weekly docetaxel 0.91 (0.75 to 1.11, p=0.36). Median survival was 16.5 months with mitoxantrone, 18.9 months with three-weekly docetaxel and 17.4 months with weekly docetaxel.\n\nThe secondary endpoints tell you what the extra months felt like. A PSA fall of at least 50 percent occurred in 32, 45 and 48 percent respectively (p<0.001 for both docetaxel comparisons). Predefined reductions in pain occurred in 22, 35 (p=0.01) and 31 percent (p=0.08), and improvements in quality of life in 13, 22 (p=0.009) and 23 percent (p=0.005). Adverse events were more common with docetaxel.\n\nThree-weekly docetaxel with prednisone became the standard of care and stayed so for a decade, and it is still the backbone that abiraterone, enzalutamide and cabazitaxel were tested around. In England NICE TA101 recommends docetaxel for hormone-refractory metastatic prostate cancer only if the Karnofsky performance status score is 60 percent or more, with treatment stopped after up to 10 cycles, on severe adverse events or on progression, and repeat courses are not recommended if the disease recurs after a completed course.","status":"positive","asOf":"2026-09-25","links":[{"label":"TAX 327 (New England Journal of Medicine 2004)","url":"https://doi.org/10.1056/NEJMoa040720"},{"label":"NICE TA101: docetaxel for the treatment of hormone-refractory metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta101"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel","mitoxantrone","prednisone"],"companies":["sanofi","cctg"],"institutions":[],"pathways":[],"terms":["castration-resistance","psa50","qol-pro","mcrpc-mhspc"],"trials":["swog-9916","tropic","chaarted"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Metastatic hormone-refractory prostate cancer: prednisone 5 mg twice daily for everyone, with mitoxantrone 12 mg/m2 every three weeks, docetaxel 75 mg/m2 every three weeks, or docetaxel 30 mg/m2 weekly for five of every six weeks, with overall survival as the primary endpoint","sponsor":"Aventis, with the National Cancer Institute of Canada Clinical Trials Group","result":"Median survival 18.9 months with three-weekly docetaxel against 16.5 months with mitoxantrone (hazard ratio for death 0.76, 95 percent confidence interval 0.62 to 0.94, p=0.009), with more pain relief (35 against 22 percent) and quality-of-life improvement (22 against 13 percent).","yearReported":2004,"enrolled":1006,"enrolledBasis":"randomised","enrolledNote":"1,006 men were randomised between March 2000 and June 2002; the trial predates the 2005 requirement to register, and no ClinicalTrials.gov record can be matched to it with confidence, so none is quoted.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Docetaxel 75 mg/m2 every 3 weeks with prednisone","value":18.9,"note":"Hazard ratio is three-weekly docetaxel against mitoxantrone; weekly docetaxel gave 0.91 (0.75 to 1.11, p=0.36)."},{"name":"Docetaxel 30 mg/m2 weekly with prednisone","value":17.4},{"name":"Mitoxantrone 12 mg/m2 every 3 weeks with prednisone","value":16.5}],"hr":0.76,"ci":[0.62,0.94],"p":"0.009","source":"https://doi.org/10.1056/NEJMoa040720"},{"endpoint":"Pain response","unit":"%","arms":[{"name":"Docetaxel every 3 weeks","value":35},{"name":"Docetaxel weekly","value":31},{"name":"Mitoxantrone","value":22}],"p":"0.01","source":"https://doi.org/10.1056/NEJMoa040720"},{"endpoint":"Quality of life improvement","unit":"%","arms":[{"name":"Docetaxel every 3 weeks","value":22},{"name":"Docetaxel weekly","value":23},{"name":"Mitoxantrone","value":13}],"p":"0.009","source":"https://doi.org/10.1056/NEJMoa040720"}],"replication":"SWOG 9916, published in the same issue, found docetaxel with estramustine also better than mitoxantrone with prednisone (median survival 17.5 against 15.6 months)."},{"id":"nct03213665","kind":"trial","name":"Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)","aka":[],"tldr":"A phase 2 trial of Tazemetostat in Sarcomas, run by National Cancer Institute (NCI), completed.","summary":"Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial) is a phase 2 interventional study registered as NCT03213665 by National Cancer Institute (NCI), with 20 participants recorded, started 2017-11-13 and reaching its primary completion in 2022-03-31. Interventions recorded: Tazemetostat. Conditions recorded: Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Low Grade Glioma, Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Glioma, Recurrent Hepatoblastoma, Recurrent Hodgkin Lymphoma, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Malignant Solid Neoplasm, Recurrent Medulloblastoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Primary Central Nervous System Neoplasm, Recurrent Rhabdoid Tumor, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Refractory Hodgkin Lymphoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Malignant Solid Neoplasm, Refractory Medulloblastoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Soft Tissue Sarcoma, Rhabdoid Tumor, Stage III Soft Tissue Sarcoma AJCC v7, Stage IV Soft Tissue Sarcoma AJCC v7, Wilms Tumor.\n\nLinked to the idea \"Group trials by broken mechanism, not by organ or single mutation\" because the registry names Tazemetostat among its interventions and Sarcomas among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03213665","url":"https://clinicaltrials.gov/study/NCT03213665"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["tazemetostat"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03213665","phase":"2","setting":"NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Tazemetostat in Patients With Tumors Harboring Alterations in EZH2 or Members of the SWI/SNF Complex","sponsor":"National Cancer Institute (NCI)","started":"2017-11-13","startedType":"actual","yearReported":2023,"enrolled":20,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Treatment (Tazemetostat)","n":20,"value":5,"note":"90% CI 1 to 20; Figures from the ClinicalTrials.gov results section (first posted 2023-04-27), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03213665?tab=results"},{"endpoint":"Progression-free Survival (PFS)","unit":"%","arms":[{"name":"Treatment (Tazemetostat)","n":20,"value":35,"note":"95% CI 15.7 to 55.2; Figures from the ClinicalTrials.gov results section (first posted 2023-04-27), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03213665?tab=results"}]},{"id":"tazemetostat-doxorubicin-es","kind":"trial","name":"Tazemetostat with doxorubicin as front-line therapy for advanced epithelioid sarcoma (EZH-301 run-in)","aka":[],"tldr":"The attempt to move the EZH2 inhibitor tazemetostat into first-line epithelioid sarcoma alongside doxorubicin; the safety run-in enrolled 25 patients and the study was stopped, leaving the accelerated approval without its confirmatory trial.","summary":"After tazemetostat's single-arm approval in 2020, Epizyme opened this study to test the drug with doxorubicin as front-line treatment for advanced epithelioid sarcoma, with a phase 1b run-in leading into a randomised phase 3. ClinicalTrials.gov records 25 participants and a terminated status; the sponsor's business changes after its acquisition by Ipsen preceded the closure. Its fate matters because the epithelioid sarcoma approval rested on a 62-patient cohort with a 15 percent response rate.","status":"withdrawn","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04204941","url":"https://clinicaltrials.gov/study/NCT04204941"},{"label":"Gounder et al., tazemetostat in advanced epithelioid sarcoma (Lancet Oncology 2020)","url":"https://doi.org/10.1016/S1470-2045(20)30451-4"}],"tags":["owner-request"],"related":[],"cancers":["epithelioid-sarcoma"],"sections":[],"technologies":["epigenetic-drugs"],"targets":["ezh2"],"drugs":["tazemetostat","doxorubicin"],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-gounder-lancet-oncol"],"journals":[],"dependsOn":[],"notes":["Registry status on 24 September 2026: Terminated (registry record last updated 7 January 2026; primary completion reached 14 June 2024). Why stopped, in the sponsor's words: FDA and Ipsen alignelment: Due to unfeasibility and the resulting inability to meet the required enrolment targets. No safety concerns."],"nct":"NCT04204941","phase":"1","setting":"Previously untreated advanced epithelioid sarcoma with loss of INI1/SMARCB1: tazemetostat added to doxorubicin, the safety run-in of the planned randomised confirmatory trial; started December 2019, 25 enrolled, terminated by the sponsor","sponsor":"Epizyme (Ipsen)","started":"2019-12-19","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05549297","kind":"trial","name":"Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)","aka":["TEBE-AM"],"tldr":"A phase 3 trial of Tebentafusp, Pembrolizumab in melanoma, run by Immunocore Ltd, now recruiting.","summary":"Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM) is a phase 3 interventional study registered as NCT05549297 by Immunocore Ltd, with 540 participants planned, started 2022-12-19 and due to reach its primary completion in 2028-03. Interventions recorded: Tebentafusp, Tebentafusp with Pembrolizumab, Investigators Choice. Conditions listed: Advanced Melanoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05549297","url":"https://clinicaltrials.gov/study/NCT05549297"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor","t-cell-engager","tcr-t"],"targets":[],"drugs":["tebentafusp","pembrolizumab"],"companies":["immunocore"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05549297","phase":"3","setting":"Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)","sponsor":"Immunocore Ltd","started":"2022-12-19","startedType":"actual","enrolled":540,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07764653","kind":"trial","name":"Technetium Tc 99m Sulfur Colloid Injection for Tracing Sentinel Nodes in Breast Cancer","aka":[],"tldr":"A phase 3 trial of Technetium Tc-99m sulfur colloid in Breast cancer, run by HTA Co., Ltd., completed.","summary":"Technetium Tc 99m Sulfur Colloid Injection for Tracing Sentinel Nodes in Breast Cancer is a phase 3 interventional study registered as NCT07764653 by HTA Co., Ltd., with 213 participants recorded, started 2024-01-02 and reaching its primary completion in 2025-06-03. Interventions recorded: Technetium Tc 99m Sulfur Colloid Injection, Mitoxantrone Hydrochloride Injection for Tracing. Conditions recorded: Sentinel Nodes, Breast Cancer.\n\nLinked to the drug Technetium Tc-99m sulfur colloid because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07764653","url":"https://clinicaltrials.gov/study/NCT07764653"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["technetium-sulfur-colloid"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07764653","phase":"3","setting":"Efficacy and Safety of Technetium Tc 99m Sulfur Colloid Injection for Tracing Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical Trial","sponsor":"HTA Co., Ltd.","started":"2024-01-02","startedType":"actual","enrolled":213,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05913674","kind":"trial","name":"Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Ciusss de L'Est de l'Île de Montréal, now recruiting.","summary":"Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC) is a phase 2, interventional study registered as NCT05913674 by Ciusss de L'Est de l'Île de Montréal, with a registry enrolment figure of 25 participants, started 2026-05-01 and due to reach its primary completion in 2028-05. Interventions recorded: Modified early post-operative intraperitoneal chemotherapy (mEPIC). Conditions listed: Peritoneal Carcinomatosis; Appendiceal Neoplasms; Colorectal Cancer Metastatic. Primary outcome: Feasibility of mEPIC. Colorectal eligibility wording from the registry: \"* Histological diagnosis of appendicular or colorectal tumors with peritoneal carcinomatosis, either synchronous (\\< 12 months after primary diagnosis) or metachronous (\\>12 months after the primary diagnosis)\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05913674","url":"https://clinicaltrials.gov/study/NCT05913674"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05913674","phase":"2","setting":"Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)","sponsor":"Ciusss de L'Est de l'Île de Montréal","started":"2026-05-01","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00660894","kind":"trial","name":"Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery","aka":[],"tldr":"A phase 3 trial of Leucovorin and Tegafur, gimeracil and oteracil in Colorectal cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan, completed.","summary":"Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery is a phase 3 interventional study registered as NCT00660894 by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan, with 1535 participants recorded, started 2008-04 and reaching its primary completion in 2012-06. Interventions recorded: folinate calcium, tegafur-uracil, tegafur-gimeracil-oteracil potassium. Conditions recorded: Colorectal Cancer.\n\nLinked to the drug Tegafur, gimeracil and oteracil because the registry names it among its interventions and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00660894","url":"https://clinicaltrials.gov/study/NCT00660894"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["leucovorin","tegafur-gimeracil-oteracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00660894","phase":"3","setting":"Randomized Phase III Study of UFT+Leucovorin vs. TS-1 as Adjuvant Treatment for Stage III Colon Cancer, and Investigate Predictive Factors Based on Gene Expression","sponsor":"Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan","started":"2008-04","enrolled":1535,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04851119","kind":"trial","name":"Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Children's Oncology Group, now recruiting.","summary":"Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors is a phase 1/2, interventional study registered as NCT04851119 by Children's Oncology Group, with a registry enrolment figure of 147 participants, started 2021-11-08 and due to reach its primary completion in 2028-06-30. Interventions recorded: Biospecimen Collection; Dual X-ray Absorptiometry; Tegavivint; X-Ray Imaging. Conditions listed: Colorectal Carcinoma; Endometrial Carcinoma; Melanoma; Neuroblastoma; Ovarian Carcinoma; Pancreatic Ductal Adenocarcinoma; Recurrent Desmoid Fibromatosis; Recurrent Ewing Sarcoma; Recurrent Hepatoblastoma; Recurrent Hepatocellular Carcinoma; Recurrent Malignant Solid Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Refractory Desmoid Fibromatosis; Refractory Ewing Sarcoma; Refractory Hepatoblastoma; Refractory Hepatocellular Carcinoma; Refractory Malignant Solid Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Solid Pseudopapillary Neoplasm of the Pancreas; Wilms Tumor. Primary outcome: Frequency of dose limiting toxicities of tegavivint; Frequency of adverse events attributable to tegavivint; Area under the drug concentration curve of tegavivint. Pancreatic eligibility wording from the registry: \"IHC showing strong nuclear beta-catenin staining will be accepted for the following tumor types: colorectal carcinoma, melanoma, endometrial cancer, ovarian cancer, neuroblastoma, non-Hodgkin lymphoma, pancreatic ductal adenocarcinoma, and solid pseudopapillary tumor of the pancreas\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04851119","url":"https://clinicaltrials.gov/study/NCT04851119"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04851119","phase":"1/2","setting":"A Phase 1/2 Study of Tegavivint (NSC#826393) in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors","sponsor":"Children's Oncology Group","started":"2021-11-08","startedType":"actual","enrolled":147,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05836870","kind":"trial","name":"Tele-PancFit: A Multi-site Trial of Video-based Strengthening Exercise Prehabilitation for Patients With Resectable Pancreatic Cancer","aka":["Tele-PancFit"],"tldr":"A phase 3 trial in pancreatic cancer, run by M.D. Anderson Cancer Center, active but no longer recruiting.","summary":"Tele-PancFit: A Multi-site Trial of Video-based Strengthening Exercise Prehabilitation for Patients With Resectable Pancreatic Cancer is a phase 3, randomised interventional study registered as NCT05836870 by M.D. Anderson Cancer Center, with a registry enrolment figure of 58 participants, started 2023-07-18 and due to reach its primary completion in 2030-12-31. Interventions recorded: Enhanced Usual Care; Tele-supervised resistance exercises. Conditions listed: Pancreatic Cancer. Primary outcome: Safety and adverse events (AEs). Pancreatic eligibility wording from the registry: \"* Biopsy-proven pancreatic adenocarcinoma, resectable/borderline resectable (T1-3, N0-2, M0)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05836870","url":"https://clinicaltrials.gov/study/NCT05836870"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["borderline-resectable-pdac","resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05836870","phase":"3","setting":"Tele-PancFit: A Multi-site Trial of Video-based Strengthening Exercise Prehabilitation for Patients With Resectable Pancreatic Cancer","sponsor":"M.D. Anderson Cancer Center","started":"2023-07-18","startedType":"actual","enrolled":58,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06528990","kind":"trial","name":"Telehealth Intervention for Ostomy Self-Management","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by City of Hope Medical Center, now recruiting.","summary":"Telehealth Intervention for Ostomy Self-Management is a phase 2, randomised interventional study registered as NCT06528990 by City of Hope Medical Center, with a registry enrolment figure of 150 participants, started 2025-01-02 and due to reach its primary completion in 2028-06-04. Interventions recorded: Telehealth Intervention; Standard of care. Conditions listed: Colorectal Cancer; Bladder Cancer. Primary outcome: Self-Efficacy for Ostomy Self-Management. Colorectal eligibility wording from the registry: \"* Patient with bladder or colorectal cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06528990","url":"https://clinicaltrials.gov/study/NCT06528990"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06528990","phase":"2","setting":"Perioperative Ostomy Self-Management Telehealth Intervention for Cancer Survivors","sponsor":"City of Hope Medical Center","started":"2025-01-02","startedType":"actual","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"telesto","kind":"trial","name":"TELESTO","aka":["CICL670A2302"],"tldr":"TELESTO is the only placebo-controlled trial of removing excess iron in people with lower-risk myelodysplastic syndrome who depend on blood transfusions; the chelator deferasirox lengthened the time before heart or liver damage, progression to leukaemia or death by about a year.","summary":"TELESTO was a randomised, double-blind, placebo-controlled trial run by Novartis in 225 patients with low- or intermediate-1-risk myelodysplastic syndrome and iron overload from repeated red cell transfusions. Patients received deferasirox, an oral iron chelator with no record in this corpus, or placebo. The primary endpoint was event-free survival, a composite of non-fatal cardiac and hepatic events, progression to acute myeloid leukaemia and death. Recruitment was slow and the design was reduced from a phase 3 to a phase 2 trial.\n\nMedian event-free survival in the registry results was 1,440 days with deferasirox against 1,091 days with placebo, a hazard ratio of 0.636, and the difference was statistically significant. The trial is the randomised evidence behind iron chelation for transfusional iron overload on the corpus's myelodysplastic syndrome page.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00940602","url":"https://clinicaltrials.gov/study/NCT00940602"},{"label":"ClinicalTrials.gov results","url":"https://clinicaltrials.gov/study/NCT00940602?tab=results"}],"tags":["soc-trials"],"related":[],"cancers":["mds-lower-risk","mds"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00940602","phase":"2","setting":"Low- or intermediate-1-risk myelodysplastic syndrome with transfusional iron overload: the oral iron chelator deferasirox or placebo (double-blind), with event-free survival as the primary endpoint","sponsor":"Novartis Pharmaceuticals","result":"Median event-free survival 1,440 days with deferasirox against 1,091 days with placebo (hazard ratio 0.636, p 0.015).","started":"2010-03-22","startedType":"actual","yearReported":2020,"enrolled":225,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival (non-fatal cardiac or hepatic event, progression to acute myeloid leukaemia, or death)","primary":true,"unit":"days","arms":[{"name":"Deferasirox","value":1440,"note":"95% CI 1,167 to 1,559 days"},{"name":"Placebo","value":1091,"note":"95% CI 820 to 1,348 days"}],"hr":0.636,"ci":[0.42,0.96],"p":"0.015","source":"https://clinicaltrials.gov/study/NCT00940602?tab=results"}]},{"id":"telimet-nsclc-01","kind":"trial","name":"TeliMET NSCLC-01","aka":[],"tldr":"The confirmatory trial for the first c-MET ADC, which was approved early on response rate alone.","summary":"TeliMET NSCLC-01, trial NCT04928846 sponsored by AbbVie, is the randomised phase 3 confirmatory trial for telisotuzumab vedotin, the first c-MET antibody-drug conjugate, which received accelerated approval in May 2025 on response rate alone. It compares telisotuzumab vedotin with docetaxel in previously treated c-Met-overexpressing, EGFR-wild-type non-squamous non-small-cell lung cancer and plans to enrol 768 patients, with enrolment ongoing and no results available. The accelerated approval rested on the single-arm LUMINOSITY study, in which about a third of patients with high c-Met expression responded, and OnCo links the trial to MET as a target. Whether a response-rate approval converts into a survival advantage over chemotherapy is exactly what this trial exists to answer. Telisotuzumab vedotin has its own page.","status":"recruiting","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT04928846","url":"https://clinicaltrials.gov/study/NCT04928846"}],"tags":[],"related":[],"cancers":["nsclc","met-altered-nsclc"],"sections":[],"technologies":["adc"],"targets":["met"],"drugs":["telisotuzumab-vedotin"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04928846","phase":"3","setting":"Previously treated c-Met-overexpressing, EGFR-wild-type non-squamous NSCLC: telisotuzumab vedotin vs docetaxel","sponsor":"AbbVie","started":"2022-03-25","startedType":"actual","enrolled":768,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing confirmatory trial for the LUMINOSITY-based accelerated approval."},{"id":"nct07323641","kind":"trial","name":"Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of osimertinib and telisotuzumab vedotin in lung cancer, run by Jonsson Comprehensive Cancer Center, now recruiting.","summary":"Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer is a phase 2, interventional study registered as NCT07323641 by Jonsson Comprehensive Cancer Center, with a registry enrolment figure of 60 participants, started 2026-02-19 and due to reach its primary completion in 2027-02-01. Interventions recorded: Biopsy Procedure; Biospecimen Collection; Computed Tomography; Magnetic Resonance Imaging; Osimertinib; Survey Administration; Telisotuzumab Vedotin. Conditions listed: Lung Non-Small Cell Carcinoma. Primary outcome: Objective response rate (ORR); Progression free survival (PFS). Lung eligibility wording from the registry: \"* Cytologically or histologically confirmed non small cell lung cancer (NSCLC), which is incurable with an activating and sensitizing EGFR mutation (e\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07323641","url":"https://clinicaltrials.gov/study/NCT07323641"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","met-altered-nsclc"],"sections":[],"technologies":["adc","kinase-inhibitors"],"targets":[],"drugs":["osimertinib","telisotuzumab-vedotin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07323641","phase":"2","setting":"A Phase II Trial of Telisotuzumab Vedotin With Osimertinib for EGFR Mutated NSCLC With c-MET Overexpression That is Progressing on Osimertinib","sponsor":"Jonsson Comprehensive Cancer Center","started":"2026-02-19","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04543955","kind":"trial","name":"Telotristat With Lutathera in Neuroendocrine Tumors","aka":[],"tldr":"A phase 2 trial of Telotristat ethyl in Neuroendocrine tumours, run by Lowell Anthony, MD, recorded as terminated on the registry.","summary":"Telotristat With Lutathera in Neuroendocrine Tumors is a phase 2 interventional study registered as NCT04543955 by Lowell Anthony, MD, with 1 participants recorded, started 2021-09-13 and due to reach its primary completion in 2022-06-03. Interventions recorded: Telotristat (Low-Dose), Telotristat (High-Dose). Conditions recorded: Neuroendocrine Tumors.\n\nLinked to the drug Telotristat ethyl because the registry names it among its interventions and Neuroendocrine tumours among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04543955","url":"https://clinicaltrials.gov/study/NCT04543955"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["neuroendocrine"],"sections":[],"technologies":[],"targets":[],"drugs":["telotristat-ethyl"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04543955","phase":"2","setting":"Study of Telotristat (Xermelo) in Combination With Luetetium Lu177 Dotatate (Lutathera) in Well-Differentiated Neuroendocrine Tumors","sponsor":"Lowell Anthony, MD","started":"2021-09-13","startedType":"actual","enrolled":1,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04919382","kind":"trial","name":"Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of atezolizumab and temozolomide in lung cancer, run by Dwight Owen, now recruiting.","summary":"Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer is a phase 2, randomised interventional study registered as NCT04919382 by Dwight Owen, with a registry enrolment figure of 56 participants, started 2022-01-26 and due to reach its primary completion in 2027-12-30. Interventions recorded: Atezolizumab; Temozolomide. Conditions listed: Extensive Stage Lung Small Cell Carcinoma; Metastatic Lung Small Cell Carcinoma; Recurrent Lung Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8. Primary outcome: Investigator-assessed objective response rate (ORR). Lung eligibility wording from the registry: \"metastatic and/or recurrent) small cell lung cancer and have progressed or recurred after platinum-based chemotherapy with immunotherapy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04919382","url":"https://clinicaltrials.gov/study/NCT04919382"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["atezolizumab","temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04919382","phase":"2","setting":"A Randomized, Multi-Cohort Phase II Trial of Temozolomide and Atezolizumab for Subsequent Line Treatment for Small Cell Lung Cancer","sponsor":"Dwight Owen","started":"2022-01-26","startedType":"actual","enrolled":56,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05128734","kind":"trial","name":"Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC)","aka":[],"tldr":"A phase 2 trial of temozolomide and olaparib in triple-negative breast cancer, run by AHS Cancer Control Alberta, not yet recruiting.","summary":"Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC) is a phase 2, randomised interventional study registered as NCT05128734 by AHS Cancer Control Alberta, with a registry enrolment figure of 40 participants, started 2026-04-01 and due to reach its primary completion in 2028-04-01. Interventions recorded: Temozolomide; Olaparib. Conditions listed: Breast Cancer Triple Negative. Triple-negative eligibility wording from the registry: \"* Female or male patients with triple negative breast cancer confirmed by pathology of the primary tumour or metastatic biopsy sample\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05128734","url":"https://clinicaltrials.gov/study/NCT05128734"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["temozolomide","olaparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05128734","phase":"2","setting":"A Randomized Phase II Study of Temozolomide Monotherapy or in Combination With Olaparib in Patients With METHYLATED 06-Methylguanine-DNA Methyltransferase (MGMT) Pre-Treated Triple Negative Breast Cancer (TNBC)","sponsor":"AHS Cancer Control Alberta","started":"2026-04-01","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07583511","kind":"trial","name":"Teniposide, Cisplatin and Serplulimab for Treatment of ES-SCLC, a Randomized Controlled Study","aka":[],"tldr":"A phase 2 trial of Teniposide, Etoposide, Serplulimab and Cisplatin in Small-cell lung cancer, run by Sun Yat-sen University, now recruiting.","summary":"Teniposide, Cisplatin and Serplulimab for Treatment of ES-SCLC, a Randomized Controlled Study is a phase 2 interventional study registered as NCT07583511 by Sun Yat-sen University, with 90 participants planned, started 2024-02-01 and due to reach its primary completion in 2027-05-01. Interventions recorded: Teniposide, Etoposide, serplulimab, cisplatin. Conditions recorded: Small-cell Lung Cancer.\n\nLinked to the drug Teniposide because the registry names it among its interventions and Small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07583511","url":"https://clinicaltrials.gov/study/NCT07583511"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["teniposide","etoposide","serplulimab","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07583511","phase":"2","setting":"Comparison of Teniposide, Cisplatin and Serplulimab Regimen With Etoposide, Cisplatin and Serplulimab Regimen for Treatment of Extensive Stage Small Lung Cancer, a Random, Open Label, Positive Control, Multicenter Study","sponsor":"Sun Yat-sen University","started":"2024-02-01","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06908993","kind":"trial","name":"Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated","aka":["COMET"],"tldr":"A phase 3 trial of tepotinib, pemetrexed, vinorelbine, docetaxel and other drugs in lung cancer, run by Intergroupe Francophone de Cancerologie Thoracique, now recruiting.","summary":"Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated is a phase 3, randomised interventional study registered as NCT06908993 by Intergroupe Francophone de Cancerologie Thoracique, with a registry enrolment figure of 133 participants, started 2025-12-09 and due to reach its primary completion in 2028-03-15. Interventions recorded: Tepotinib; Pemetrexed (Alimta); Vinorelbine; Gemcitabine alone; Docetaxel; Paclitaxel; Pembrolizumab; Nivolumab; Atezolizumab. Conditions listed: Advanced Non Small Cell Lung Cancer; MET Exon 14 Mutation. Primary outcome: Progression-Free Survival (PFS). Lung eligibility wording from the registry: \"Histologically proven advanced NSCLC\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06908993","url":"https://clinicaltrials.gov/study/NCT06908993"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["met-altered-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["tepotinib","pemetrexed","vinorelbine","docetaxel","paclitaxel","pembrolizumab","nivolumab","atezolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06908993","phase":"3","setting":"A Randomized Controlled Trial of Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer","sponsor":"Intergroupe Francophone de Cancerologie Thoracique","started":"2025-12-09","startedType":"actual","enrolled":133,"enrolledBasis":"registry","outcomes":[]},{"id":"tesla-rct","kind":"trial","name":"TESLA RCT","aka":["TESLA"],"tldr":"The Dutch TESLA trial randomises people whose bile ducts are blocked high in the liver by an unremovable tumour, including gallbladder cancer, to a stent placed through the skin and left above the duodenum or to the usual endoscopic drainage, counting major complications over 90 days.","summary":"TESLA (NCT06671418) is a randomised trial at Erasmus MC for patients with unresectable malignant hilar biliary obstruction from non-resectable cholangiocarcinoma, gallbladder cancer or liver metastases. Patients are randomised to primary percutaneous stenting with a metal stent placed above the ampulla, avoiding the duodenal reflux and cholangitis of transpapillary stents, or to endoscopic biliary drainage. The primary endpoint is major complications within 90 days of randomisation; 148 patients are planned, the trial opened in August 2023 by invitation and lists primary completion in November 2027. Gallbladder cancer invading the hilum is a common cause of this presentation, and the trial addresses the unresolved percutaneous versus endoscopic question after the INTERCPT trial closed for slow accrual.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06671418","url":"https://clinicaltrials.gov/study/NCT06671418"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma","extrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["biliary-stenting-drainage"],"targets":[],"drugs":[],"companies":[],"institutions":["erasmus-mc"],"pathways":[],"terms":["biliary-drainage-routes","biliary-stent","obstructive-jaundice"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06671418","phase":"3","setting":"Unresectable malignant hilar biliary obstruction (cholangiocarcinoma, gallbladder cancer, liver metastases): primary percutaneous stenting above the ampulla versus endoscopic biliary drainage, randomised, primary endpoint major complications within 90 days","sponsor":"Erasmus Medical Center","started":"2023-08-09","startedType":"actual","enrolled":148,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06084806","kind":"trial","name":"Test-retest Evaluation of [18F]F-AraG PET","aka":[],"tldr":"A phase 2 trial of [18F]F-ARAG PET in non-small-cell lung cancer, run by CellSight Technologies, Inc., now recruiting.","summary":"Test-retest Evaluation of [18F]F-AraG PET is a phase 2 interventional study registered as NCT06084806 by CellSight Technologies, Inc., with 10 participants planned, started 2023-10-31 and due to reach its primary completion in 2025-10-31. Interventions recorded: [18F]F-ARAG PET.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06084806","url":"https://clinicaltrials.gov/study/NCT06084806"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["pet"],"targets":[],"drugs":[],"companies":["cellsight-technologies"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06084806","phase":"2","setting":"Test-retest Evaluation of [18F]F-AraG PET in Non-small Cell Lung Cancer (NSCLC) Patients","sponsor":"CellSight Technologies, Inc.","started":"2023-10-31","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06907342","kind":"trial","name":"Testing a Functional Precision Medicine Approach to Select Chemotherapy for Metastatic Colorectal Cancer (COSENSE-1)","aka":["COSENSE-1"],"tldr":"A phase 2 trial in colorectal cancer, run by St. Olavs Hospital, now recruiting.","summary":"Testing a Functional Precision Medicine Approach to Select Chemotherapy for Metastatic Colorectal Cancer (COSENSE-1) is a phase 2, interventional study registered as NCT06907342 by St. Olavs Hospital, with a registry enrolment figure of 148 participants, started 2025-05-23 and due to reach its primary completion in 2027-12. Interventions recorded: FOLFOX or FOLFIRI. Conditions listed: Tumor, Colorectal; Organoids; Tumoroid; Metastatic Colorectal Cancer; Core Needle Biopsy; First-line Treatment. Primary outcome: Test the feasibility of using a functional precision medicine platform to select oxaliplatin-based versus irinotecan-based chemotherapy regimens for patients with metastatic colorectal cancer.; Test the feasibility of using a functional precision medicine platform to select oxaliplatin-based versus . Colorectal eligibility wording from the registry: \"Histologically confirmed pMMR/MSS adenocarcinoma originating from the colon or rectum\". Sites: Norway. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06907342","url":"https://clinicaltrials.gov/study/NCT06907342"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06907342","phase":"2","setting":"COSENSE-1: A Feasibility Study for Using a Functional Precision Medicine Platform to Select Oxaliplatin-based Versus Irinotecan-based Chemotherapy Regimens for Patients With Metastatic Colorectal Cancer","sponsor":"St. Olavs Hospital","started":"2025-05-23","startedType":"actual","enrolled":148,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05053971","kind":"trial","name":"Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors is a phase 1/2, interventional study registered as NCT05053971 by National Cancer Institute (NCI), with a registry enrolment figure of 49 participants, started 2022-11-16 and due to reach its primary completion in 2027-07-01. Interventions recorded: BET Bromodomain Inhibitor ZEN-3694; Computed Tomography; Core Biopsy; Entinostat. Conditions listed: Advanced Malignant Solid Neoplasm; Locally Advanced Pancreatic Carcinoma; Metastatic Pancreatic Carcinoma; Refractory Malignant Solid Neoplasm; Refractory Pancreatic Carcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Carcinoma. Primary outcome: Maximum tolerated dose (MTD) (Phase Ib); Recommended phase 2 dose (RP2D) (Phase Ib); Objective response rate (ORR) (Phase II). Pancreatic eligibility wording from the registry: \"* For patients in Phase 2: Patients must have locally advanced, unresectable OR metastatic pancreatic cancer refractory to standard therapy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05053971","url":"https://clinicaltrials.gov/study/NCT05053971"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05053971","phase":"1/2","setting":"Phase Ib/II Study of ZEN003694 and Entinostat in Advanced and Refractory Solid Tumors","sponsor":"National Cancer Institute (NCI)","started":"2022-11-16","startedType":"actual","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04941287","kind":"trial","name":"Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of atezolizumab and cobimetinib in gallbladder cancer and other biliary tract cancers, run by National Cancer Institute (NCI), active and no longer recruiting.","summary":"Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer is a phase 2, randomised interventional study registered as NCT04941287 by National Cancer Institute (NCI), with a registry enrolment figure of 57 participants, started 2021-12-15 and due to reach its primary completion in 2024-01-02. Interventions recorded: Atezolizumab, Biopsy, Biospecimen Collection, Cobimetinib, Computed Tomography, Magnetic Resonance Imaging, Varlilumab. Conditions listed: Metastatic Distal Bile Duct Adenocarcinoma, Metastatic Gallbladder Carcinoma, Metastatic Intrahepatic Cholangiocarcinoma, Recurrent Distal Bile Duct Adenocarcinoma, Recurrent Gallbladder Carcinoma, Recurrent Intrahepatic Cholangiocarcinoma, Stage IV Distal Bile Duct Cancer AJCC v8, Stage IV Gallbladder Cancer AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Unresectable Liver Carcinoma. Sites: United States. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04941287","url":"https://clinicaltrials.gov/study/NCT04941287"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["atezolizumab","cobimetinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04941287","phase":"2","setting":"A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers","sponsor":"National Cancer Institute (NCI)","started":"2021-12-15","startedType":"actual","yearReported":2025,"enrolled":57,"enrolledBasis":"registry","outcomes":[{"endpoint":"Duration of Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Arm A (Cobimetinib, Atezolizumab, Varlilumab)","n":29,"value":2.4,"note":"range 1.97 to 5.00; Figures from the ClinicalTrials.gov results section (first posted 2025-05-23), not from a publication"},{"name":"Arm B (Atezolizumab, Varlilumab)","n":28,"value":1.84,"note":"range 1.64 to 2.43"}],"source":"https://clinicaltrials.gov/study/NCT04941287?tab=results"},{"endpoint":"Duration of Overall Survival (OS)","unit":"days","arms":[{"name":"Arm A (Cobimetinib, Atezolizumab, Varlilumab)","n":29,"value":183,"note":"range 19 to 381; Figures from the ClinicalTrials.gov results section (first posted 2025-05-23), not from a publication"},{"name":"Arm B (Atezolizumab, Varlilumab)","n":28,"value":157,"note":"range 21 to 422"}],"source":"https://clinicaltrials.gov/study/NCT04941287?tab=results"}]},{"id":"nct06958328","kind":"trial","name":"Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer","aka":["LAP100"],"tldr":"A phase 3 trial of capecitabine, fluorouracil (5-FU), gemcitabine, irinotecan (and liposomal irinotecan) and other drugs in pancreatic cancer, run by NRG Oncology, now recruiting.","summary":"Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer is a phase 3, randomised interventional study registered as NCT06958328 by NRG Oncology, with a registry enrolment figure of 356 participants, started 2025-08-21 and due to reach its primary completion in 2030-10-21. Interventions recorded: Biopsy Procedure; Biospecimen Collection; Capecitabine; Computed Tomography; Dose-escalated Radiation Therapy; Fluorouracil; Gemcitabine; Irinotecan Hydrochloride; Irinotecan Sucrosofate; Leucovorin Calcium; Magnetic Resonance Imaging; Nab-paclitaxel; Observation Activity; Oxaliplatin; Positron Emission Tomography; Questionnaire Administration; Radiation Therapy; Tumor Treating Fields Therapy. Conditions listed: Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8. Primary outcome: Overall survival (OS). Pancreatic eligibility wording from the registry: \"* Pathologically (histologically or cytologically) proven diagnosis of pancreatic ductal adenocarcinoma\". Sites: Canada, United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06958328","url":"https://clinicaltrials.gov/study/NCT06958328"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","topoisomerase-inhibitors","ttfields"],"targets":[],"drugs":["capecitabine","fluorouracil","gemcitabine","irinotecan","leucovorin","nab-paclitaxel","capox"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06958328","phase":"3","setting":"A Phase III Randomized Trial of Dose Escalated Radiation in Locally Advanced Pancreas Cancer (LAPC) Patients (LAP100)","sponsor":"NRG Oncology","started":"2025-08-21","startedType":"actual","enrolled":356,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04804644","kind":"trial","name":"Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of M","aka":[],"tldr":"A phase 3 trial in lung cancer, run by NRG Oncology, active but no longer recruiting.","summary":"Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability is a phase 3, randomised interventional study registered as NCT04804644 by NRG Oncology, with a registry enrolment figure of 152 participants, started 2021-06-08 and due to reach its primary completion in 2026-06-24. Interventions recorded: Biospecimen Collection; Magnetic Resonance Imaging; Memantine Hydrochloride; Neurocognitive Assessment; Stereotactic Radiosurgery; Survey Administration; Whole-Brain Radiotherapy. Conditions listed: Metastatic Lung Small Cell Carcinoma; Metastatic Malignant Neoplasm in the Brain; Recurrent Lung Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8. Primary outcome: Time to neurocognitive failure. Lung eligibility wording from the registry: \"* Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration\". Sites: Canada, United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04804644","url":"https://clinicaltrials.gov/study/NCT04804644"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04804644","phase":"3","setting":"Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for Brain Metastases From Small Cell Lung Cancer","sponsor":"NRG Oncology","started":"2021-06-08","startedType":"actual","enrolled":152,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07359456","kind":"trial","name":"Testing Ivonescimab in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancers Without Liver Metastases","aka":["COLIBRI-GI"],"tldr":"A phase 2 trial of ivonescimab and bevacizumab (glioblastoma use) in colorectal cancer, run by UNICANCER, not yet recruiting.","summary":"Testing Ivonescimab in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancers Without Liver Metastases is a phase 2, randomised interventional study registered as NCT07359456 by UNICANCER, with a registry enrolment figure of 130 participants, started 2026-08-31 and due to reach its primary completion in 2029-08. Interventions recorded: Ivonescimab; Bevacizumab; FOLFIRI Protocol. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Progression Free Survival (PFS). Colorectal eligibility wording from the registry: \"Histologically confirmed diagnosis of non resectable pMMR (by IHC) and MSS (by molecular biology) and BRAFwt metastatic colorectal cancer with no liver metastasis\". Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07359456","url":"https://clinicaltrials.gov/study/NCT07359456"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab","bevacizumab-glioma"],"companies":["summit-therapeutics","unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07359456","phase":"2","setting":"Randomized Phase 2 Study of Second-line Chemotherapy Comparing FOLFIRI + Ivonescimab Versus FOLFIRI + Bevacizumab in Microsatellite Stable (MSS)/ Proficient MisMatch Repair (pMMR) BRAF Wild Type (BRAFwt) Advanced Colorectal Cancer (mCRC) Without Liver Metastases","sponsor":"UNICANCER","started":"2026-08-31","startedType":"estimated","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06500455","kind":"trial","name":"Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain","aka":[],"tldr":"A phase 3 trial in lung cancer, run by NRG Oncology, active but no longer recruiting.","summary":"Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain is a phase 3, randomised interventional study registered as NCT06500455 by NRG Oncology, with a registry enrolment figure of 274 participants, started 2024-12-12 and due to reach its primary completion in 2028-06-30. Interventions recorded: Computed Tomography; Fractionated Stereotactic Radiation Therapy; Magnetic Resonance Imaging; Stereotactic Radiosurgery. Conditions listed: Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Metastatic Digestive System Carcinoma; Metastatic Lung Non-Small Cell Carcinoma; Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Solid Neoplasm; Metastatic Melanom. Primary outcome: Time to local failure. Lung eligibility wording from the registry: \"* Non-small cell lung cancer\". Sites: Canada, Hong Kong, Ireland, United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06500455","url":"https://clinicaltrials.gov/study/NCT06500455"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06500455","phase":"3","setting":"Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases","sponsor":"NRG Oncology","started":"2024-12-12","startedType":"actual","enrolled":274,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07437287","kind":"trial","name":"Testing Mitazalimab in Combination With Standard Chemotherapy in Immunotherapy Resistant Advanced Biliary Tract Cancers","aka":["CROCOBIL"],"tldr":"A phase 2/3 trial of FOLFOX in gallbladder cancer and other biliary tract cancers, run by UNICANCER, not yet recruiting.","summary":"Testing Mitazalimab in Combination With Standard Chemotherapy in Immunotherapy Resistant Advanced Biliary Tract Cancers is a phase 2/3, randomised interventional study registered as NCT07437287 by UNICANCER, with a registry enrolment figure of 160 participants, started 2026-07 and due to reach its primary completion in 2030-04. Interventions recorded: mFOLFOX regimen, Mitazalimab. Conditions listed: Biliary Tract Cancer (BTC). Gallbladder cancer is named in the registry entry: \"2. Histologically-proven intrahepatic cholangiocarcinoma, extrahepatic (perihilar/distal) cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded)\". Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07437287","url":"https://clinicaltrials.gov/study/NCT07437287"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07437287","phase":"2/3","setting":"Countering Immunotherapy Resistance With Novel Combinations in Advanced Biliary Tract Cancers","sponsor":"UNICANCER","started":"2026-07","startedType":"estimated","enrolled":160,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06500481","kind":"trial","name":"Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial","aka":["Radiate-LM"],"tldr":"A phase 3 trial in lung cancer, run by NRG Oncology, now recruiting.","summary":"Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial is a phase 3, randomised interventional study registered as NCT06500481 by NRG Oncology, with a registry enrolment figure of 115 participants, started 2025-03-04 and due to reach its primary completion in 2028-07-31. Interventions recorded: Biospecimen Collection; Computed Tomography; Involved-Field Radiation Therapy; Lumbar Puncture; Magnetic Resonance Imaging; Positron Emission Tomography; Proton Beam Craniospinal Irradiation; Quality-of-Life Assessment. Conditions listed: Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Metastatic Lung Non-Small Cell Carcinoma; Metastatic Malignant Neoplasm in the Leptomeninges; Stage IV Lung Cancer AJCC v8. Primary outcome: Overall survival (OS). Lung eligibility wording from the registry: \"* Patients with pathologically (histologically or cytologically) proven diagnosis of breast cancer or NSCLC\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06500481","url":"https://clinicaltrials.gov/study/NCT06500481"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["imrt-igrt","proton-therapy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06500481","phase":"3","setting":"A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (Radiate-LM)","sponsor":"NRG Oncology","started":"2025-03-04","startedType":"actual","enrolled":115,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05863195","kind":"trial","name":"Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial","aka":[],"tldr":"A phase 3 trial of Cetuximab, Floxuridine, Fluorouracil, Irinotecan, Leucovorin, Oxaliplatin and Panitumumab in Colorectal cancer, run by ECOG-ACRIN Cancer Research Group, now recruiting.","summary":"Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial is a phase 3 interventional study registered as NCT05863195 by ECOG-ACRIN Cancer Research Group, with 408 participants planned, started 2023-10-19 and due to reach its primary completion in 2029-06-30. Interventions recorded: Bevacizumab, Cetuximab, Computed Tomography, Floxuridine, Fluorouracil, Implantation, Intrahepatic Infusion Procedure, Irinotecan, Leucovorin, Oxaliplatin, Panitumumab, Single Photon Emission Computed Tomography. Conditions recorded: Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Stage IV Colorectal Cancer AJCC v8, Unresectable Colorectal Carcinoma.\n\nLinked to the drug Floxuridine because the registry names it among its interventions and Colorectal cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05863195","url":"https://clinicaltrials.gov/study/NCT05863195"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["cetuximab","floxuridine","fluorouracil","irinotecan","leucovorin","oxaliplatin","panitumumab"],"companies":["ecog-acrin"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05863195","phase":"3","setting":"A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial","sponsor":"ECOG-ACRIN Cancer Research Group","started":"2024-04-10","startedType":"actual","enrolled":408,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04172532","kind":"trial","name":"Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial in pancreatic cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer is a phase 1/2, randomised interventional study registered as NCT04172532 by National Cancer Institute (NCI), with a registry enrolment figure of 92 participants, started 2021-01-11 and due to reach its primary completion in 2027-08-01. Interventions recorded: Biopsy Procedure; Biospecimen Collection; Computed Tomography; Hypofractionated Radiation Therapy; Magnetic Resonance Imaging; Peposertib; Placebo Administration. Conditions listed: Locally Advanced Pancreatic Adenocarcinoma; Stage III Pancreatic Cancer AJCC v8. Primary outcome: Maximum tolerated dose (Phase I); Recommended phase 2 dose (Phase I); Progression-free survival rate (Phase II). Pancreatic eligibility wording from the registry: \"* Patients must have pathologically confirmed pancreatic adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04172532","url":"https://clinicaltrials.gov/study/NCT04172532"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04172532","phase":"1/2","setting":"A Phase 1/2 Study of M3814 (Peposertib) in Combination With Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma","sponsor":"National Cancer Institute (NCI)","started":"2021-01-11","startedType":"actual","enrolled":92,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03811002","kind":"trial","name":"Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemoradiation (CRT) Therapy Treatment for Limited Stage Small Cell Lun","aka":[],"tldr":"A phase 3 trial of atezolizumab, carboplatin, cisplatin and etoposide in lung cancer, run by National Cancer Institute (NCI), active but no longer recruiting.","summary":"Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemoradiation (CRT) Therapy Treatment for Limited Stage Small Cell Lung Cancer (LS-SCLC) is a phase 3, randomised interventional study registered as NCT03811002 by National Cancer Institute (NCI), with a registry enrolment figure of 544 participants, started 2019-07-26 and due to reach its primary completion in 2024-04-21. Interventions recorded: 3-Dimensional Conformal Radiation Therapy; Atezolizumab; Biospecimen Collection; Carboplatin; Cisplatin; Etoposide; Intensity-Modulated Radiation Therapy; Quality-of-Life Assessment; Questionnaire Administration. Conditions listed: Limited Stage Lung Small Cell Carcinoma; Stage I Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8. Primary outcome: Overall Survival. Lung eligibility wording from the registry: \"* Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer \\[AJCC\\] staging, 8th edition \\[Ed\". Sites: Japan, United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03811002","url":"https://clinicaltrials.gov/study/NCT03811002"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["limited-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["atezolizumab","carboplatin","cisplatin","etoposide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03811002","phase":"3","setting":"Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab","sponsor":"National Cancer Institute (NCI)","started":"2019-07-26","startedType":"actual","enrolled":544,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04267848","kind":"trial","name":"Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Ch","aka":[],"tldr":"A phase 3 trial of carboplatin, cisplatin, gemcitabine, paclitaxel / nab-paclitaxel and other drugs in lung cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO]) is a phase 3, randomised interventional study registered as NCT04267848 by National Cancer Institute (NCI), with a registry enrolment figure of 1210 participants, started 2020-06-16 and due to reach its primary completion in 2027-01-31. Interventions recorded: Biospecimen Collection; Carboplatin; Cisplatin; Computed Tomography; Echocardiography Test; Gemcitabine Hydrochloride; Magnetic Resonance Imaging; Observation Activity; Paclitaxel; Pembrolizumab; Pemetrexed Disodium; Questionnaire Administration. Conditions listed: Lung Non-Small Cell Carcinoma; Lung Non-Small Cell Squamous Carcinoma; Lung Non-Squamous Non-Small Cell Carcinoma; Stage II Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8. Primary outcome: Disease free survival (DFS). Lung eligibility wording from the registry: \"* Completely resected stage IIA, IIB IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC) (squamous or non-squamous) with negative margins (complete R0 resection)\". Sites: Guam, United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04267848","url":"https://clinicaltrials.gov/study/NCT04267848"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","cisplatin","gemcitabine","paclitaxel","pembrolizumab","pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04267848","phase":"3","setting":"Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO)","sponsor":"National Cancer Institute (NCI)","started":"2020-06-16","startedType":"actual","enrolled":1210,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05610163","kind":"trial","name":"Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage","aka":["JANUS"],"tldr":"A phase 2/3 trial of capecitabine, fluorouracil (5-FU), leucovorin (folinic acid), fOLFIRI (5-FU, leucovorin, irinotecan) and other drugs in colorectal cancer, run by Alliance for Clinical Trials in Oncology, active but no longer recruiting.","summary":"Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation and Continuing Response is a phase 2/3, randomised interventional study registered as NCT05610163 by Alliance for Clinical Trials in Oncology, with a registry enrolment figure of 760 participants, started 2022-12-08 and due to reach its primary completion in 2026-09-30. Interventions recorded: Capecitabine; 5-fluorouracil; Leucovorin calcium; Irinotecan; Oxaliplatin; Long Course Chemoradiotherapy; Computed Tomography; Magnetic Resonance Imaging; Sigmoidoscopy; biopsy. Conditions listed: Stage II Rectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Locally Advanced Rectal Adenocarcinoma. Primary outcome: Clincal Complete Response (cCR) Rates (Phase II); Disease-free survival (DFS) rate (Phase III). Colorectal eligibility wording from the registry: \"* Histologic Documentation: rectal adenocarcinoma, mismatch repair proficient (pMMR)\". Sites: Puerto Rico, United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05610163","url":"https://clinicaltrials.gov/study/NCT05610163"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["capecitabine","fluorouracil","leucovorin","folfiri","folfox"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05610163","phase":"2/3","setting":"The Janus Rectal Cancer Trial: A Randomized Phase II/III Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy Regarding Clinical Complete Response and Disease-free Survival in Patients With Locally Advanced Rectal Cancer","sponsor":"Alliance for Clinical Trials in Oncology","started":"2022-12-08","startedType":"actual","enrolled":760,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04092283","kind":"trial","name":"Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Anti","aka":[],"tldr":"A phase 3 trial of carboplatin, cisplatin, durvalumab, etoposide and other drugs in lung cancer, run by National Cancer Institute (NCI), active but no longer recruiting.","summary":"Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT04092283 by National Cancer Institute (NCI), with a registry enrolment figure of 660 participants, started 2020-04-29 and due to reach its primary completion in 2028-12-31. Interventions recorded: Carboplatin; Cisplatin; Durvalumab; Etoposide; Paclitaxel; Pemetrexed Disodium. Conditions listed: Recurrent Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Unresectable Lung Non-Small Cell Carcinoma. Primary outcome: Overall survival (OS). Lung eligibility wording from the registry: \"* Newly diagnosed stage IIIA/B/C non-small cell lung cancer (NSCLC) (per the American Joint Committee on Cancer \\[AJCC\\] 8th edition) that is unresectable and is histologically and/or cytologically confirmed\". Sites: Guam, United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04092283","url":"https://clinicaltrials.gov/study/NCT04092283"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["carboplatin","cisplatin","durvalumab","etoposide","paclitaxel","pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04092283","phase":"3","setting":"Randomized Phase III Trial of MEDI4736 (Durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC","sponsor":"National Cancer Institute (NCI)","started":"2020-04-29","startedType":"actual","enrolled":660,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03606967","kind":"trial","name":"Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of carboplatin, durvalumab, gemcitabine, nab-paclitaxel and other drugs in triple-negative breast cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer is a phase 2, randomised interventional study registered as NCT03606967 by National Cancer Institute (NCI), with a registry enrolment figure of 86 participants, started 2021-04-13 and due to reach its primary completion in 2026-12-30. Interventions recorded: Biopsy Procedure; Biospecimen Collection; Carboplatin; Computed Tomography; Durvalumab; Gemcitabine Hydrochloride; Magnetic Resonance Imaging; Nab-paclitaxel; Personalized Synthetic Long Peptide Vaccine; Poly ICLC; Sacituzumab Govitecan; Tremelimumab. Conditions listed: Anatomic Stage IV Breast Cancer AJCC v8; Invasive Breast Carcinoma; Metastatic Triple-Negative Breast Carcinoma. Triple-negative eligibility wording from the registry: \"* Patients must have a histologically confirmed diagnosis of metastatic invasive triple negative breast cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03606967","url":"https://clinicaltrials.gov/study/NCT03606967"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["adc","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","durvalumab","gemcitabine","nab-paclitaxel","sacituzumab-govitecan","tremelimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03606967","phase":"2","setting":"Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer","sponsor":"National Cancer Institute (NCI)","started":"2021-04-13","startedType":"actual","enrolled":86,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02997228","kind":"trial","name":"Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study","aka":["COMMIT"],"tldr":"A phase 3 trial of atezolizumab, bevacizumab (glioblastoma use), fluorouracil (5-FU) and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by National Cancer Institute (NCI), active but no longer recruiting.","summary":"Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study is a phase 3, randomised interventional study registered as NCT02997228 by National Cancer Institute (NCI), with a registry enrolment figure of 120 participants, started 2018-01-19 and due to reach its primary completion in 2027-06-01. Interventions recorded: Atezolizumab; Bevacizumab; Biospecimen Collection; Computed Tomography; Fluorouracil; Leucovorin; Magnetic Resonance Imaging; Oxaliplatin; Positron Emission Tomography; Quality-of-Life Assessment; Questionnaire Administration. Conditions listed: Metastatic Colorectal Adenocarcinoma; Stage IV Colorectal Cancer AJCC v7. Primary outcome: Progression free survival (PFS). Colorectal eligibility wording from the registry: \"* Diagnosis of metastatic adenocarcinoma of colon or rectum without previous chemotherapy or any other systemic therapy for metastatic colorectal cancer except for one cycle of FOLFOX or capecitabine and oxaliplatin (CAPOX), either with or without bevacizumab prior to enrollment\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02997228","url":"https://clinicaltrials.gov/study/NCT02997228"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["atezolizumab","bevacizumab-glioma","fluorouracil","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02997228","phase":"3","setting":"Colorectal Cancer Metastatic dMMR/MSI-H Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab/Atezolizumab Combination Versus Single Agent Atezolizumab in the First-Line Treatment of Patients With Deficient DNA Mismatch Repair (dMMR)/Microsatellite Instability-High (MSI-H) Metastatic Colorectal Cancer","sponsor":"National Cancer Institute (NCI)","started":"2018-01-19","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06732401","kind":"trial","name":"Testing the Addition of AZD6738 (Ceralasertib) to Immunotherapy to Increase Time Without Cancer for Patients With Non-Small Cell Lung Cancer","aka":["CLEAR"],"tldr":"A phase 3 trial of ceralasertib and durvalumab in lung cancer, run by National Cancer Institute (NCI), active but no longer recruiting.","summary":"Testing the Addition of AZD6738 (Ceralasertib) to Immunotherapy to Increase Time Without Cancer for Patients With Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT06732401 by National Cancer Institute (NCI), with a registry enrolment figure of 630 participants, started 2025-08-07 and due to reach its primary completion in 2028-06-30. Interventions recorded: Biospecimen Collection; Ceralasertib; Computed Tomography; Durvalumab; Echocardiography Test. Conditions listed: Lung Non-Small Cell Carcinoma; Stage II Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8. Primary outcome: Disease free survival (DFS). Lung eligibility wording from the registry: \"* STEP 0: Patient must have stage II to select stage IIIB (N2 but excluding N3) non-small cell lung cancer (NSCLC) of any histology using International Association for the Study of Lung Cancer (IASLC) 8th edition\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06732401","url":"https://clinicaltrials.gov/study/NCT06732401"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ceralasertib","durvalumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06732401","phase":"3","setting":"A Randomized Phase III Trial of Checkpoint Blockade in Lung CancEr Patients in the Adjuvant Setting Based on Pathologic Response Following Neoadjuvant Therapy (CLEAR)","sponsor":"National Cancer Institute (NCI)","started":"2025-08-07","startedType":"actual","enrolled":630,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05624996","kind":"trial","name":"Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of carboplatin, cisplatin, durvalumab, etoposide and other drugs in lung cancer, run by NRG Oncology, now recruiting.","summary":"Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT05624996 by NRG Oncology, with a registry enrolment figure of 474 participants, started 2023-07-12 and due to reach its primary completion in 2031-10-15. Interventions recorded: Carboplatin; Cisplatin; Computed Tomography; Durvalumab; Etoposide; Image Guided Radiation Therapy; Nab-paclitaxel; Osimertinib; Paclitaxel; Pemetrexed; Positron Emission Tomography; Questionnaire Administration; Stereotactic Body Radiation Therapy. Conditions listed: Locally Advanced Lung Non-Small Cell Carcinoma; Stage IIB Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8. Primary outcome: Overall survival (OS); Progression-free survival (PFS). Lung eligibility wording from the registry: \"* Pathologically (histologically or cytologically) proven diagnosis of non-operable stage IIB or III, node positive (American Joint Committee on Cancer \\[AJCC\\] eighth edition) non-small cell lung cancer (NSCLC) with known PD-L1 status prior to registration\". Sites: Canada, United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05624996","url":"https://clinicaltrials.gov/study/NCT05624996"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","kinase-inhibitors","platinum","sbrt","topoisomerase-inhibitors"],"targets":[],"drugs":["carboplatin","cisplatin","durvalumab","etoposide","nab-paclitaxel","osimertinib","paclitaxel","pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05624996","phase":"3","setting":"Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally-Advanced Non-Small Cell Lung Cancer","sponsor":"NRG Oncology","started":"2023-07-12","startedType":"actual","enrolled":474,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04929041","kind":"trial","name":"Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Pati","aka":[],"tldr":"A phase 2/3 trial of ipilimumab and nivolumab in lung cancer, run by National Cancer Institute (NCI), active but no longer recruiting.","summary":"Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative is a phase 2/3, randomised interventional study registered as NCT04929041 by National Cancer Institute (NCI), with a registry enrolment figure of 427 participants, started 2022-10-07 and due to reach its primary completion in 2030-12-12. Interventions recorded: Biopsy Procedure; Biospecimen Collection; Computed Tomography; Echocardiography Test; Ipilimumab; Magnetic Resonance Imaging; Nivolumab; Positron Emission Tomography; Quality-of-Life Assessment; Radiation Therapy. Conditions listed: Lung Adenocarcinoma; Lung Adenosquamous Carcinoma; Lung Non-Small Cell Carcinoma; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8. Primary outcome: Progression-free survival (PFS) (Phase II); Overall survival (OS) (Phase III). Lung eligibility wording from the registry: \"* Histologic or cytologic diagnosis of stage IV NSCLC using version American Joint Committee on Cancer (AJCC) 8th edition (includes M1a, M1b, and M1c stage disease)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04929041","url":"https://clinicaltrials.gov/study/NCT04929041"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-adenocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["ipilimumab","nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04929041","phase":"2/3","setting":"A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without Radiation Therapy for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer","sponsor":"National Cancer Institute (NCI)","started":"2022-10-07","startedType":"actual","enrolled":427,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04214262","kind":"trial","name":"Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of atezolizumab and fludeoxyglucose F-18 (FDG) in lung cancer, run by National Cancer Institute (NCI), active but no longer recruiting.","summary":"Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT04214262 by National Cancer Institute (NCI), with a registry enrolment figure of 415 participants, started 2020-08-13 and due to reach its primary completion in 2024-08-24. Interventions recorded: Atezolizumab; Biospecimen Collection; Computed Tomography; Fludeoxyglucose F-18; Positron Emission Tomography; Quality-of-Life Assessment; Questionnaire Administration; Stereotactic Body Radiation Therapy. Conditions listed: Lung Non-Small Cell Carcinoma; Stage I Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8. Primary outcome: Overall survival. Lung eligibility wording from the registry: \"* Patient must have histologically or cytologically proven stage I-IIA or limited T3N0M0 non-small cell lung cancer (NSCLC), without radiographic evidence of nodal or distant involvement (N0M0)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04214262","url":"https://clinicaltrials.gov/study/NCT04214262"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","sbrt"],"targets":[],"drugs":["atezolizumab","fludeoxyglucose-f18"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04214262","phase":"3","setting":"A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC","sponsor":"National Cancer Institute (NCI)","started":"2020-08-13","startedType":"actual","enrolled":415,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05673148","kind":"trial","name":"Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Alliance for Clinical Trials in Oncology, now recruiting.","summary":"Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial is a phase 2, randomised interventional study registered as NCT05673148 by Alliance for Clinical Trials in Oncology, with a registry enrolment figure of 146 participants, started 2023-10-09 and due to reach its primary completion in 2028-07-03. Interventions recorded: Stereotactic Ablative Radiotherapy; Resection; Microwave Ablation; Chemotherapy; Computed Tomography; Magnetic Resonance Imaging; Positron Emission Tomography. Conditions listed: Metastatic Colorectal Adenocarcinoma; Stage IV Colorectal Cancer AJCC v8; Oligometastatic Colorectal Carcinoma. Primary outcome: Overall Survival (OS). Colorectal eligibility wording from the registry: \"* PRE-REGISTRATION (STEP 0): Pathologically proven diagnosis of metastatic colorectal adenocarcinoma with metastases (biopsy from primary tumor or metastatic site is acceptable)\". Sites: Canada, United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05673148","url":"https://clinicaltrials.gov/study/NCT05673148"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["sbrt","thermal-ablation"],"targets":[],"drugs":[],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05673148","phase":"2","setting":"A Pragmatic Randomized Phase II Trial Evaluating Total Ablative Therapy for Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur)","sponsor":"Alliance for Clinical Trials in Oncology","started":"2023-10-09","startedType":"actual","enrolled":146,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07551596","kind":"trial","name":"Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial","aka":[],"tldr":"A phase 2 trial of balstilimab and botensilimab in colorectal cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial is a phase 2, interventional study registered as NCT07551596 by National Cancer Institute (NCI), with a registry enrolment figure of 20 participants, started 2027-05-25 and due to reach its primary completion in 2029-08-28. Interventions recorded: Balstilimab; Biopsy Procedure; Biospecimen Collection; Botensilimab; Radiographic Examination. Conditions listed: Colorectal Adenocarcinoma; Stage II Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8. Primary outcome: Circulating tumor deoxyribonucleic acid (ctDNA) clearance. Colorectal eligibility wording from the registry: \"* Histological confirmation of colorectal cancer (adenocarcinoma) (CRC)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07551596","url":"https://clinicaltrials.gov/study/NCT07551596"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","mrd-testing"],"targets":[],"drugs":["balstilimab","botensilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07551596","phase":"2","setting":"A Phase 2 Study of Microsatellite Stable Colorectal Cancer (Stage 2 or 3) With Radiographic Occult Molecular Residual Disease Treated With Botensilimab (AGEN1181; Bot) Plus Balstilimab (AGEN2034, Bal) After Established Definitive Therapy (COMBAT Study)","sponsor":"National Cancer Institute (NCI)","started":"2027-05-25","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07619521","kind":"trial","name":"Testing the Combination of Anti-Cancer Drugs, Selumetinib and DS-8201a (Trastuzumab Deruxtecan), for Advanced Pancreatic Ductal Adenocarcinoma","aka":[],"tldr":"A phase 1/2 trial of selumetinib and trastuzumab deruxtecan in pancreatic cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Testing the Combination of Anti-Cancer Drugs, Selumetinib and DS-8201a (Trastuzumab Deruxtecan), for Advanced Pancreatic Ductal Adenocarcinoma is a phase 1/2, interventional study registered as NCT07619521 by National Cancer Institute (NCI), with a registry enrolment figure of 31 participants, started 2027-06-01 and due to reach its primary completion in 2028-09-08. Interventions recorded: Biospecimen Collection; Diagnostic Imaging Testing; Echocardiography Test; Multigated Acquisition Scan; Selumetinib; Trastuzumab Deruxtecan. Conditions listed: Advanced Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Ductal Adenocarcinoma. Primary outcome: Occurrence of dose limiting toxicities (DLTs) (dose escalation phase); HER2 expression status (dose escalation phase); Overall response rate (phase II). Pancreatic eligibility wording from the registry: \"* Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07619521","url":"https://clinicaltrials.gov/study/NCT07619521"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["selumetinib","trastuzumab-deruxtecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07619521","phase":"1/2","setting":"Phase I/II Study of the MEK Inhibitor Selumetinib Plus DS-8201a (Trastuzumab Deruxtecan) in KRAS-Mutant, HER2-Expressing Pancreatic Ductal Adenocarcinoma","sponsor":"National Cancer Institute (NCI)","started":"2027-06-01","startedType":"estimated","enrolled":31,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04068194","kind":"trial","name":"Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies","aka":[],"tldr":"A phase 1/2 trial of avelumab with radiotherapy in gallbladder cancer and other biliary tract cancers, run by National Cancer Institute (NCI), active and no longer recruiting.","summary":"Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies is a phase 1/2, randomised interventional study registered as NCT04068194 by National Cancer Institute (NCI), with a registry enrolment figure of 103 participants, started 2020-04-07 and due to reach its primary completion in 2027-07-01. Interventions recorded: Avelumab, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Hypofractionated Radiation Therapy, Peposertib. Conditions listed: Locally Advanced Malignant Solid Neoplasm, Locally Advanced Unresectable Cholangiocarcinoma, Locally Advanced Unresectable Gallbladder Carcinoma, Locally Advanced Unresectable Malignant Solid Neoplasm, Metastatic Cholangiocarcinoma, Metastatic Gallbladder Carcinoma, Metastatic Malignant Solid Neoplasm, Stage III Gallbladder Cancer AJCC v8, Stage IV Gallbladder Cancer AJCC v8, Unresectable Malignant Solid Neoplasm. Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04068194","url":"https://clinicaltrials.gov/study/NCT04068194"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["avelumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04068194","phase":"1/2","setting":"A Phase I/II Study of M3814 and Avelumab in Combination With Hypofractionated Radiation in Patients With Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies","sponsor":"National Cancer Institute (NCI)","started":"2020-04-07","startedType":"actual","enrolled":103,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05691491","kind":"trial","name":"Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness","aka":[],"tldr":"A phase 1/2 trial of temozolomide in colorectal cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness is a phase 1/2, interventional study registered as NCT05691491 by National Cancer Institute (NCI), with a registry enrolment figure of 42 participants, started 2023-09-28 and due to reach its primary completion in 2027-03-01. Interventions recorded: Biopsy Procedure; Biospecimen Collection; Computed Tomography; Magnetic Resonance Imaging; Temozolomide; Tuvusertib. Conditions listed: Advanced Malignant Solid Neoplasm; Advanced Microsatellite Stable Colorectal Carcinoma; Hematopoietic and Lymphatic System Neoplasm; Metastatic Malignant Solid Neoplasm; Metastatic Microsatellite Stable Colorectal Carcinoma; Stage III Colorectal Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8. Primary outcome: Dose limiting toxicity and the maximum tolerated dose. Colorectal eligibility wording from the registry: \"Patients with MGMT promoter hypermethylated colorectal cancer must be mismatch repair proficient / microsatellite stable\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05691491","url":"https://clinicaltrials.gov/study/NCT05691491"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["temozolomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05691491","phase":"1/2","setting":"A Phase 1/2 Trial Evaluating the Combination of Temozolomide and the Ataxia Telangiectasia and Rad3-Related Inhibitor M1774","sponsor":"National Cancer Institute (NCI)","started":"2023-09-28","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03492671","kind":"trial","name":"Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of nab-paclitaxel in pancreatic cancer, run by Loma Linda University, now recruiting.","summary":"Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer is a phase 2, interventional study registered as NCT03492671 by Loma Linda University, with a registry enrolment figure of 30 participants, started 2019-07-17 and due to reach its primary completion in 2026-09. Interventions recorded: Gemcitabine 1000 mg; nab-paclitaxel; Stereotactic Body Radiation Therapy. Conditions listed: Pancreas Adenocarcinoma; Resectable Pancreatic Cancer. Primary outcome: Curative Intent Resection (R0) rate. Pancreatic eligibility wording from the registry: \"* Cytologic or histologic proof of adenocarcinoma of the pancreas\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03492671","url":"https://clinicaltrials.gov/study/NCT03492671"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","sbrt"],"targets":[],"drugs":["nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03492671","phase":"2","setting":"A Phase II Trial of Pre-operative Chemotherapy (With Gemcitabine and Nab- Paclitaxel) and Stereotactic Body Radiotherapy Followed by Surgery and Chemotherapy in Patients With Resectable Pancreatic Adenocarcinoma","sponsor":"Loma Linda University","started":"2019-07-17","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07147231","kind":"trial","name":"Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810), in Treating Refracto","aka":[],"tldr":"A phase 1/2 trial of cemiplimab in colorectal cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810), in Treating Refractory Microsatellite Stable Colorectal Cancer is a phase 1/2, randomised interventional study registered as NCT07147231 by National Cancer Institute (NCI), with a registry enrolment figure of 86 participants, started 2026-08-10 and due to reach its primary completion in 2027-09-30. Interventions recorded: Biopsy Procedure; Biospecimen Collection; Cemiplimab; Computed Tomography; Magnetic Resonance Imaging; Pidnarulex; Positron Emission Tomography. Conditions listed: Metastatic Colorectal Adenocarcinoma; Refractory Colorectal Adenocarcinoma; Stage III Colorectal Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Unresectable Colorectal Adenocarcinoma. Primary outcome: Recommended phase 2 dose (RP2D) of pidnarulex (CX-5461) with anti-programmed cell death protein 1 (anti-PD-1) (Phase 1); Incidence of adverse events, serious adverse events, and dose limiting toxicities; Progression-free survival (PFS) (Phase II). Colorectal eligibility wording from the registry: \"* Patients must have pathologically confirmed colorectal adenocarcinoma that is unresectable and/or metastatic and for which standard curative or palliative measures do not exist or are no longer effective\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07147231","url":"https://clinicaltrials.gov/study/NCT07147231"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07147231","phase":"1/2","setting":"A Phase 1 and Randomized Phase 2 Trial of Pidnarulex (CX-5461) and Cemiplimab (REGN2810) in Refractory Microsatellite Stable Colorectal Cancer","sponsor":"National Cancer Institute (NCI)","started":"2026-08-10","startedType":"actual","enrolled":86,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07061951","kind":"trial","name":"Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia","aka":[],"tldr":"A phase 2 trial of Mirdametinib in Chronic lymphocytic leukaemia, run by National Cancer Institute (NCI), now recruiting.","summary":"Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia is a phase 2 interventional study registered as NCT07061951 by National Cancer Institute (NCI), with 20 participants planned, started 2026-05-27 and due to reach its primary completion in 2030-02-01. Interventions recorded: Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography, Echocardiography Test, Mirdametinib. Conditions recorded: Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Small Lymphocytic Lymphoma.\n\nLinked to the drug Mirdametinib because the registry names it among its interventions and Chronic lymphocytic leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07061951","url":"https://clinicaltrials.gov/study/NCT07061951"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":[],"targets":[],"drugs":["mirdametinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07061951","phase":"2","setting":"A Phase 2 Pilot Study of Mirdametinib in Relapsed Refractory Chronic Lymphocytic Leukemia","sponsor":"National Cancer Institute (NCI)","started":"2026-05-27","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07388524","kind":"trial","name":"Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial","aka":["AASI-NSCLC"],"tldr":"A phase 3 trial of atezolizumab in lung cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial is a phase 3, randomised interventional study registered as NCT07388524 by National Cancer Institute (NCI), with a registry enrolment figure of 336 participants, started 2027-03-02 and due to reach its primary completion in 2032-09-30. Interventions recorded: Atezolizumab; Atezolizumab and Recombinant Human Hyaluronidase; Biospecimen Collection; Computed Tomography; Patient Observation. Conditions listed: Lung Non-Small Cell Carcinoma. Primary outcome: Disease-free survival. Lung eligibility wording from the registry: \"* Pathologically stage IA3 or IB NSCLC per American Joint Committee on Cancer (AJCC) Cancer Staging Manual, 9th edition\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07388524","url":"https://clinicaltrials.gov/study/NCT07388524"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07388524","phase":"3","setting":"Evaluating Adjuvant Atezolizumab or Atezolizumab and Hyaluronidase-TQJS to Prevent Recurrence in Stage I Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase III Trial (AASI-NSCLC)","sponsor":"National Cancer Institute (NCI)","started":"2027-03-02","startedType":"estimated","enrolled":336,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03793179","kind":"trial","name":"Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 3 trial of carboplatin, pembrolizumab and pemetrexed in lung cancer, run by National Cancer Institute (NCI), active but no longer recruiting.","summary":"Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT03793179 by National Cancer Institute (NCI), with a registry enrolment figure of 600 participants, started 2019-04-05 and due to reach its primary completion in 2027-09-30. Interventions recorded: Biospecimen Collection; Carboplatin; Computed Tomography; Magnetic Resonance Imaging; Pembrolizumab; Pemetrexed; Positron Emission Tomography. Conditions listed: Lung Non-Squamous Non-Small Cell Carcinoma; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8. Primary outcome: Overall survival (OS). Lung eligibility wording from the registry: \"* Patients must have histologically or cytologically confirmed stage IV non-squamous non-small cell lung cancer (NSCLC) (includes M1a, M1b, and M1c stage disease, American Joint Committee on Cancer \\[AJCC\\] 8th edition)\". Sites: Canada, Guam, United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03793179","url":"https://clinicaltrials.gov/study/NCT03793179"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","pembrolizumab","pemetrexed"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03793179","phase":"3","setting":"EA5163/S1709 INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination With Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Immunobiomarker Signature-Driven Analysis","sponsor":"National Cancer Institute (NCI)","started":"2019-04-05","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05710406","kind":"trial","name":"Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer","aka":[],"tldr":"A phase 2/3 trial of encorafenib and cetuximab in colorectal cancer, run by Alliance for Clinical Trials in Oncology, active but no longer recruiting.","summary":"Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer is a phase 2/3, randomised interventional study registered as NCT05710406 by Alliance for Clinical Trials in Oncology, with a registry enrolment figure of 1 participants, started 2023-08-16 and due to reach its primary completion in 2034-06-01. Interventions recorded: Encorafenib; Cetuximab; Biospecimen Collection; Computed Tomography; Magnetic Resonance Imaging; Patient Observation. Conditions listed: Colon Adenocarcinoma; Microsatellite Stable Colon Carcinoma; Stage IIB Colon Cancer AJCC v8; Stage IIC Colon Cancer AJCC v8; Stage III Colon Cancer AJCC v8. Primary outcome: Circulating tumor deoxyribonucleic acid (ctDNA) clearance rate (Phase II; ctDNA positive cohort); tDNA recurrence-free survival rate (ctDNA-RFS) (Phase II; ctDNA negative cohort); Disease free survival (DFS) (Phase III). Colorectal eligibility wording from the registry: \"* Pre-registration for central tumor testing will occur after colon resection\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05710406","url":"https://clinicaltrials.gov/study/NCT05710406"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer","braf-v600e-colorectal"],"sections":[],"technologies":["kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["encorafenib","cetuximab"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05710406","phase":"2/3","setting":"Randomized Trial of Consolidation Targeted Adjuvant Therapy With Encorafenib and Cetuximab Versus Usual Care for Patients With Stage II/III BRAF V600E Colon Cancer","sponsor":"Alliance for Clinical Trials in Oncology","started":"2023-08-16","startedType":"actual","enrolled":1,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05096663","kind":"trial","name":"Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2/3 trial of dexamethasone, docetaxel, gemcitabine, pembrolizumab and other drugs in lung cancer, run by SWOG Cancer Research Network, active but no longer recruiting.","summary":"Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial) is a phase 2/3, randomised interventional study registered as NCT05096663 by SWOG Cancer Research Network, with a registry enrolment figure of 82 participants, started 2022-03-15 and due to reach its primary completion in 2027-06-30. Interventions recorded: Cobalamin; Dexamethasone; Docetaxel; Folic Acid; Gemcitabine; Nogapendekin Alfa; Pembrolizumab; Pemetrexed; Ramucirumab. Conditions listed: Advanced Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lu. Primary outcome: Overall survival. Lung eligibility wording from the registry: \"Assignment to S1800D is determined by the LUNGMAP or S1400 protocol\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05096663","url":"https://clinicaltrials.gov/study/NCT05096663"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["dexamethasone","docetaxel","gemcitabine","pembrolizumab","pemetrexed","ramucirumab"],"companies":["swog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05096663","phase":"2/3","setting":"A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated With Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)","sponsor":"SWOG Cancer Research Network","started":"2022-03-15","startedType":"actual","enrolled":82,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07151586","kind":"trial","name":"Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Lo","aka":["ALTER"],"tldr":"A phase 2 trial of sacituzumab govitecan and trastuzumab deruxtecan in triple-negative breast cancer, run by UNICANCER, not yet recruiting.","summary":"Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Locally Advanced Triple-negative Breast Cancer is a phase 2, randomised interventional study registered as NCT07151586 by UNICANCER, with a registry enrolment figure of 260 participants, started 2026-09 and due to reach its primary completion in 2029-10. Interventions recorded: Sacituzumab Govitecan / Trastuzumab Deruxtecan. Conditions listed: Triple Negative Breast Neoplasms; Neoplasm Metastasis; HER 2 Low-expressing Breast Cancer. Triple-negative eligibility wording from the registry: \"* Histologically confirmed metastatic or locally advanced and unresectable triple-negative breast cancer, meeting both of the following criteria by local testing:\". Sites: France. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07151586","url":"https://clinicaltrials.gov/study/NCT07151586"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-govitecan","trastuzumab-deruxtecan"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07151586","phase":"2","setting":"A Phase 2, Multicenter, Randomized, Open-label Trial Assessing Sacituzumab-govitecan and Trastuzumab-deruxtecan Combinations in an Alternating Regimen for Patients With Metastatic or Locally Advanced HER2-low Triple-negative Breast Cancer","sponsor":"UNICANCER","started":"2026-09","startedType":"estimated","enrolled":260,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05955391","kind":"trial","name":"TGRX-326 Chinese Phase II for Advanced Non-small Cell Lung Cancer (NSCLC)","aka":[],"tldr":"A phase 2 trial of TGRX-326 in non-small-cell lung cancer and small-cell lung cancer, run by Shenzhen TargetRx Co., Ltd., active and no longer recruiting.","summary":"TGRX-326 Chinese Phase II for Advanced Non-small Cell Lung Cancer (NSCLC) is a phase 2 interventional study registered as NCT05955391 by Shenzhen TargetRx Co., Ltd., with 164 participants enrolled, started 2023-01-18 and due to reach its primary completion in 2024-12-29. Interventions recorded: TGRX-326. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05955391","url":"https://clinicaltrials.gov/study/NCT05955391"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","alk-positive-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["tgrx-326"],"companies":["shenzhen-targetrx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05955391-j-thorac-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05955391","phase":"2","setting":"A Multi-centered, Open-label, Single-arm Phase II Study to Evaluate the Safety and Efficacy of TGRX-326 Monotherapy in Patients of Advanced ALK-positiveNon-Small Cell Lung Cancer Who Failed 2nd-Generation ALK Inhibitor Therapies","sponsor":"Shenzhen TargetRx Co., Ltd.","started":"2023-01-18","startedType":"actual","enrolled":164,"enrolledBasis":"registry","outcomes":[]},{"id":"nsclc-3","kind":"trial","name":"TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC)","aka":[],"tldr":"A phase 3 trial testing TGRX-326 in non-small-cell lung cancer, active and no longer recruiting.","summary":"TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC) is a phase 3 interventional study registered as NCT06082635, led by Shenzhen TargetRx with Sun Yat-Sen University Cancer Center, and active but no longer recruiting on the registry. Official title: A Multi-centered, Randomised, Open-label Phase III Study to Evaluate the Efficacy and Safety of TGRX-326 Comparing With Crizotinib in Patients of Advanced ALK-positive or Metastatic Non-Small Cell Lung Cancer. Planned enrolment is 321 participants (actual). The study started in 2023-12-14 and primary completion is expected in 2026-04-30. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06082635","url":"https://clinicaltrials.gov/study/NCT06082635"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","alk-positive-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["tgrx-326"],"companies":["shenzhen-targetrx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06082635","phase":"3","setting":"A Multi-centered, Randomized, Open-label Phase III Study to Evaluate the Efficacy and Safety of TGRX-326 Comparing With Crizotinib in Patients of Advanced ALK-positive or Metastatic Non-Small Cell Lung Cancer","sponsor":"Shenzhen TargetRx","started":"2023-12-14","startedType":"actual","enrolled":321,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06453902","kind":"trial","name":"TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients","aka":[],"tldr":"A phase 2 trial of TGRX-678 in chronic myeloid leukaemia, run by Shenzhen TargetRx Co., Ltd., now recruiting.","summary":"TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients is a phase 2 interventional study registered as NCT06453902 by Shenzhen TargetRx Co., Ltd., with 40 participants planned, started 2024-07-15 and due to reach its primary completion in 2026-06-30. Interventions recorded: TGRX-678.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06453902","url":"https://clinicaltrials.gov/study/NCT06453902"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cml","cml-advanced-phase"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shenzhen-targetrx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06453902","phase":"2","setting":"A Single-arm, Open-label, Multi-center Phase II Study Evaluating Efficacy and Safety of TGRX-678 in CML-AP Patients Relapsed or Refractory From 3rd-generation TKI Treatment","sponsor":"Shenzhen TargetRx Co., Ltd.","started":"2024-07-15","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06206174","kind":"trial","name":"TGRX-814 Chinese Phase I/II in Patients With Hematological Malignancies","aka":[],"tldr":"A phase 1/2 trial of TGRX-814 in non-Hodgkin lymphoma, acute myeloid leukaemia, acute lymphoblastic leukaemia and myelodysplastic syndromes / neoplasms, run by Shenzhen TargetRx Co., Ltd., now recruiting.","summary":"TGRX-814 Chinese Phase I/II in Patients With Hematological Malignancies is a phase 1/2 interventional study registered as NCT06206174 by Shenzhen TargetRx Co., Ltd., with 30 participants planned, started 2024-03-06 and due to reach its primary completion in 2025-02-28. Interventions recorded: TGRX-814.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06206174","url":"https://clinicaltrials.gov/study/NCT06206174"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","aml","all-leukemia","mds"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shenzhen-targetrx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06206174","phase":"1/2","setting":"A Single-arm, Open-label, Dose Escalation and Expansion Phase I/II Study Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-814 Monotherapy and Combination Therapy in Patients With Hematological Malignancies","sponsor":"Shenzhen TargetRx Co., Ltd.","started":"2024-03-06","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06279351","kind":"trial","name":"Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Xinqiao Hospital of Chongqing, now recruiting.","summary":"Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer is a phase 2, interventional study registered as NCT06279351 by Xinqiao Hospital of Chongqing, with a registry enrolment figure of 96 participants, started 2024-08-11 and due to reach its primary completion in 2025-12-31. Interventions recorded: Thalidomide+cetuximab+FOLFOX/FOLFIRI. Conditions listed: Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer. Primary outcome: ETS. Colorectal eligibility wording from the registry: \"Patients with RAS and BRAF wild-type IV unresectable left colorectal cancer confirmed by pathology and tissue/cytology and genetic testing;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06279351","url":"https://clinicaltrials.gov/study/NCT06279351"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06279351","phase":"2","setting":"Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer","sponsor":"Xinqiao Hospital of Chongqing","started":"2024-08-11","startedType":"actual","enrolled":96,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06017284","kind":"trial","name":"Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer","aka":["PTCA199-5"],"tldr":"A phase 3 trial of thalidomide, nab-paclitaxel and gemcitabine in pancreatic cancer, run by Fudan University, now recruiting.","summary":"Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer is a phase 3, randomised interventional study registered as NCT06017284 by Fudan University, with a registry enrolment figure of 100 participants, started 2023-11-01 and due to reach its primary completion in 2025-11-30. Interventions recorded: Thalidomide; Nab paclitaxel; Gemcitabine; Placebo. Conditions listed: Pancreatic Cancer Stage IV; Chemotherapy-induced Nausea and Vomiting. Primary outcome: Rate of nausea/vomiting. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed metastatic pancreas adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06017284","url":"https://clinicaltrials.gov/study/NCT06017284"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["thalidomide","nab-paclitaxel","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06017284","phase":"3","setting":"Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer","sponsor":"Fudan University","started":"2023-11-01","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06930118","kind":"trial","name":"The Aim of This Study is to Assess the Efficacy and Safety of Chidamide, Regorafenib in Combination With Iparomlimab and Tuvonralimab for the Treatment of Advan","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Shanghai Changzheng Hospital, now recruiting.","summary":"The Aim of This Study is to Assess the Efficacy and Safety of Chidamide, Regorafenib in Combination With Iparomlimab and Tuvonralimab for the Treatment of Advanced Colorectal Cancer in Third-line Therapy and Subsequent Lines. is a phase 2, interventional study registered as NCT06930118 by Shanghai Changzheng Hospital, with a registry enrolment figure of 60 participants, started 2025-04-10 and due to reach its primary completion in 2027-04-30. Interventions recorded: chidamide, regorafenib, and iparomlimab/tuvonralimab. Conditions listed: Advanced Colorectal Cancer in the Third-line Treatment and Beyond; pMMR/MSS Advanced Colorectal Cancer. Primary outcome: Objective response rate, ORR. Colorectal eligibility wording from the registry: \"* Patients with advanced colorectal adenocarcinoma confirmed by histology or cytology;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06930118","url":"https://clinicaltrials.gov/study/NCT06930118"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06930118","phase":"2","setting":"An Exploratory Study Investigating the Combination of Chidamide, Regorafenib, Plus Iparomlimab and Tuvonralimab for the Treatment of Drug-esistant and Efractory Dvanced Colorectal Cancer","sponsor":"Shanghai Changzheng Hospital","started":"2025-04-10","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07285044","kind":"trial","name":"The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients","aka":[],"tldr":"A phase 2 trial in pancreatic cancer, run by Mayo Clinic, now recruiting.","summary":"The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas is a phase 2, interventional study registered as NCT07285044 by Mayo Clinic, with a registry enrolment figure of 27 participants, started 2025-12-18 and due to reach its primary completion in 2026-12-18. Interventions recorded: Cancer Therapeutic Procedure; Cancer Therapeutic Procedure; Questionnaire Administration. Conditions listed: Amyloidosis; Basal Cell Carcinoma; Biliary Tract Carcinoma; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Fallopian Tube Carcinoma; Gastroesophageal Junction Carcinoma; Glioblastoma; Head and Neck Carcinoma; Hematopoietic and Lymphatic System Neoplasm; Hepatocellular Carcinoma; Hodgkin Lymphoma; Lung Carcinoma; Malignant Solid Neoplasm; Mantle Cell Lymphoma; Melanoma; Merkel Cell Carcinoma; Multiple Myeloma; Myelodysplastic Syndrome; Ovarian Carcinoma; Pancreatic Carcinoma; Primary Peritoneal Carcinoma; Prostate Carcinoma; Renal Cell Carcinoma; Squamous Cell Carcinoma; Urothelial Carcinoma. Primary outcome: Patient preferences regarding location of cancer treatment delivery; Adverse Events Related to Location of Treatment; Incidence of avoidable acute care visits, emergency room visits, and hospitalizations. Pancreatic eligibility wording from the registry: \"* Pancreatic\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07285044","url":"https://clinicaltrials.gov/study/NCT07285044"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07285044","phase":"2","setting":"Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","sponsor":"Mayo Clinic","started":"2025-12-18","startedType":"actual","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02000089","kind":"trial","name":"The Cancer of the Pancreas Screening-5 CAPS5)Study","aka":["CAPS5"],"tldr":"A phase 3 trial in pancreatic cancer, run by Johns Hopkins University, now recruiting.","summary":"The Cancer of the Pancreas Screening-5 CAPS5)Study is a phase 3, interventional study registered as NCT02000089 by Johns Hopkins University, with a registry enrolment figure of 9000 participants, started 2014-01-06 and due to reach its primary completion in 2028-12. Interventions recorded: Secretin; MRI; Tumor marker gene test with CA19-9. Conditions listed: Pancreas Cancer; Peutz-Jeghers Syndrome (PJS); Gene Mutation; Germline Mutation Carrier; Lynch Syndrome. Primary outcome: Evaluate pancreatic juice for early cancer markers.. Pancreatic eligibility wording from the registry: \"* Hereditary Pancreatitis or\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02000089","url":"https://clinicaltrials.gov/study/NCT02000089"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02000089","phase":"3","setting":"The Cancer of the Pancreas Screening-5 CAPS5)Study","sponsor":"Johns Hopkins University","started":"2014-01-06","startedType":"actual","enrolled":9000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07704645","kind":"trial","name":"The Clinical Study of Adalimumab Combined With Other Anti-tumor Therapy as a Treatment for Resectable Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of adebrelimab in lung cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd., not yet recruiting.","summary":"The Clinical Study of Adalimumab Combined With Other Anti-tumor Therapy as a Treatment for Resectable Non-small Cell Lung Cancer is a phase 2, interventional study registered as NCT07704645 by Suzhou Suncadia Biopharmaceuticals Co., Ltd., with a registry enrolment figure of 180 participants, started 2026-08 and due to reach its primary completion in 2028-06. Interventions recorded: Adebrelimab Injection combined with SHR-1826 Injection combined with SHR-8068 Injection; Adebrelimab Injection combined with HRS-7058 Capsule. Conditions listed: Resectable Non-small Cell Lung Cancer. Primary outcome: Pathological complete response (pCR) rate: pCR is defined as the absence of any residual tumor at the time of surgical resection.. Lung eligibility wording from the registry: \"Patients with histopathologically or cytologically confirmed Stage II, IIIA, or select Stage IIIB (AJCC 9th edition) non-small cell lung cancer who are candidates for curative-intent R0 surgical resection\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07704645","url":"https://clinicaltrials.gov/study/NCT07704645"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["adebrelimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07704645","phase":"2","setting":"A Phase II Clinical Study of Adebelizumab Combined With Other Anti-tumor Treatments as a Perioperative Treatment for Resectable Non-small Cell Lung Cancer","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","started":"2026-08","startedType":"estimated","enrolled":180,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06851299","kind":"trial","name":"The Clinical Study of the Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategy in the Treatment of Advanced Triple-negative Breast","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, now recruiting.","summary":"The Clinical Study of the Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategy in the Treatment of Advanced Triple-negative Breast Cancer. is a phase 2, randomised interventional study registered as NCT06851299 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, with a registry enrolment figure of 60 participants, started 2025-03-01 and due to reach its primary completion in 2027-04-30. Interventions recorded: trop2-ADC; ADC +anti-angiogenic drug; ADC + PD1 monoclonal antibody +anti-angiogenic drug. Conditions listed: Metastatic Triple-negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* 1\\) adult female patients (aged 18-70 years) with metastatic triple negative breast cancer confirmed by pathology or imaging;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06851299","url":"https://clinicaltrials.gov/study/NCT06851299"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06851299","phase":"2","setting":"Randomized Controlled Clinical Study of Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategies in the Treatment of Advanced Triple-negative Breast Cancer","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","started":"2025-03-01","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06452706","kind":"trial","name":"The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of TQB2102 in advanced solid tumours, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., now recruiting.","summary":"The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer is a phase 2 interventional study registered as NCT06452706 by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., with 42 participants planned, started 2024-11-14 and due to reach its primary completion in 2026-06. Interventions recorded: TQB2102 for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06452706","url":"https://clinicaltrials.gov/study/NCT06452706"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb2102"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06452706","phase":"2","setting":"The Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection in Human Epidermal Growth Factor Receptor 2 (HER2) Negative Recurrent/Metastatic Breast Cancer","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","started":"2024-11-14","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05628038","kind":"trial","name":"The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer","aka":["TORCH-R"],"tldr":"A phase 2 trial of capecitabine, fluorouracil (5-FU), leucovorin (folinic acid), fOLFOX (5-FU, leucovorin, oxaliplatin) and other drugs in colorectal cancer, run by Fudan University, now recruiting.","summary":"The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer is a phase 2, interventional study registered as NCT05628038 by Fudan University, with a registry enrolment figure of 93 participants, started 2022-11-30 and due to reach its primary completion in 2024-12-01. Interventions recorded: PD-1 antibody; Capecitabine; 5FU; folinic acid; Oxaliplatin; Irinotecan; Raltitrexed; Cetuximab; Bevacizumab; Radiation. Conditions listed: Recurrent Rectal Cancer. Primary outcome: Local objective response rate. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05628038","url":"https://clinicaltrials.gov/study/NCT05628038"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","monoclonal-antibody","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["capecitabine","fluorouracil","leucovorin","folfox","folfiri","raltitrexed","cetuximab","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05628038","phase":"2","setting":"Hypofractionated Radiotherapy Combined With Toripalimab and Chemotherapy +/- Target Therapy for Locally Recurrent Rectal Cancer: a Single-arm, Two-cohort, Phase II Trial (TORCH-R)","sponsor":"Fudan University","started":"2022-11-30","startedType":"actual","enrolled":93,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05555888","kind":"trial","name":"The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer","aka":["TORCH-E"],"tldr":"A phase 2 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Fudan University, now recruiting.","summary":"The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer is a phase 2, interventional study registered as NCT05555888 by Fudan University, with a registry enrolment figure of 34 participants, started 2022-12-12 and due to reach its primary completion in 2024-03-12. Interventions recorded: PD-1 antibody; Capecitabine; Oxaliplatin; Short-course radiotherapy. Conditions listed: Early Low Rectal Cancer. Primary outcome: complete response (CR) rate. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05555888","url":"https://clinicaltrials.gov/study/NCT05555888"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capecitabine","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05555888","phase":"2","setting":"A Prospective Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer","sponsor":"Fudan University","started":"2022-12-12","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06355427","kind":"trial","name":"The Effect of [18F] F-FAPI PET-CT on Management in Patients With Proximal Cholangiocarcinoma","aka":["FAPIChol"],"tldr":"A phase 2/3 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by Mara Veenstra, MD, now recruiting.","summary":"The Effect of [18F] F-FAPI PET-CT on Management in Patients With Proximal Cholangiocarcinoma is a phase 2/3 interventional study registered as NCT06355427 by Mara Veenstra, MD, with a registry enrolment figure of 81 participants, started 2024-11-29 and due to reach its primary completion in 2027-09-01. Interventions recorded: [18F]F-FAPI PET-CT. Conditions listed: Cholangiocarcinoma. Gallbladder cancer is named in the registry entry: \"* Patient is scheduled for explorative laparoscopy or laparotomy for suspicion of proximal cholangiocarcinoma (perihilar, intrahepatic and gall bladder cholangiocarcinoma)\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06355427","url":"https://clinicaltrials.gov/study/NCT06355427"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06355427","phase":"2/3","setting":"The Effect of [18F] F-FAPI PET-CT on Management in Patients With Potentially Resectable Biliary Tract Cancers: Prospective Multicenter Study and Cost-effectivity Analysis","sponsor":"Mara Veenstra, MD","started":"2024-11-29","startedType":"actual","enrolled":81,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06861088","kind":"trial","name":"The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer","aka":["CATIQ P3"],"tldr":"A phase 3 trial of Kinisoquin™ in pancreatic ductal adenocarcinoma, run by Quercis Pharma AG, now recruiting.","summary":"The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer is a phase 3 interventional study registered as NCT06861088 by Quercis Pharma AG, with 480 participants planned, started 2025-12-19 and due to reach its primary completion in 2027-10-31. Interventions recorded: Kinisoquin™ and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06861088","url":"https://clinicaltrials.gov/study/NCT06861088"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06861088","phase":"3","setting":"A Randomized, Placebo-Controlled, Double-Blind Phase 3 Trial Comparing, Relative to Placebo, the Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer (CATIQ P3)","sponsor":"Quercis Pharma AG","started":"2025-12-19","startedType":"actual","enrolled":480,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06254521","kind":"trial","name":"The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer","aka":[],"tldr":"A phase 2 trial of tislelizumab in colorectal cancer, run by First Affiliated Hospital of Guangxi Medical University, now recruiting.","summary":"The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer is a phase 2, interventional study registered as NCT06254521 by First Affiliated Hospital of Guangxi Medical University, with a registry enrolment figure of 60 participants, started 2024-02-22 and due to reach its primary completion in 2024-12-30. Interventions recorded: Tislelizumab combined with chemotherapy. Conditions listed: Rectal Cancer; Rectal Cancer Stage II; Rectal Cancer Stage III. Primary outcome: Pathological complete response (pCR) rate. Colorectal eligibility wording from the registry: \"* Pathologically diagnosed MSS ((confirmed by microsatellite stable detection or next-generation target sequencing) or (confirmed by immunohistochemistry)) colon adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06254521","url":"https://clinicaltrials.gov/study/NCT06254521"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06254521","phase":"2","setting":"Neoadjuvant Treatment of Locally Advanced MSS Rectal Cancer With Tislelizumab Combined With CAPOX Regimen: a Prospective, Single-arm, Single-center, Exploratory Phase II Clinical Study","sponsor":"First Affiliated Hospital of Guangxi Medical University","started":"2024-02-22","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06959589","kind":"trial","name":"The Efficacy and Safety of IBI351, Cetuximab β Combined With FOLFIRI as First-line /IBI351, Cetuximab β as Second-line in the Treatment of KRAS G12C-mutated Met","aka":["cruciall"],"tldr":"A phase 2 trial in colorectal cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"The Efficacy and Safety of IBI351, Cetuximab β Combined With FOLFIRI as First-line /IBI351, Cetuximab β as Second-line in the Treatment of KRAS G12C-mutated Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT06959589 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 50 participants, started 2025-05-22 and due to reach its primary completion in 2027-05-31. Interventions recorded: IBI351, cetuximab β combined with FOLFIRI. Conditions listed: Colorectal Cancer Metastatic; KRAS G12C Mutation. Primary outcome: ORR. Colorectal eligibility wording from the registry: \"The patient must have histologically and/or cytologically confirmed metastatic colorectal cancer (stage IV) 3\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06959589","url":"https://clinicaltrials.gov/study/NCT06959589"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","kras-g12c-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06959589","phase":"2","setting":"An Open-label, Multicenter, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of IBI351, Cetuximab β Combined With FOLFIRI as First-line /IBI351, Cetuximab β as Second-line in the Treatment of KRAS G12C-mutated Metastatic Colorectal Cancer","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2025-05-22","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06140576","kind":"trial","name":"The Efficacy and Safety of Lenvatinib Combined With Sindilimab and Nab-paclitaxel in the First-line Treatment for Recurrent and Metastatic Triple Negative Breas","aka":[],"tldr":"A phase 1/2 trial of nab-paclitaxel and lenvatinib in triple-negative breast cancer, run by Zhejiang Cancer Hospital, not yet recruiting.","summary":"The Efficacy and Safety of Lenvatinib Combined With Sindilimab and Nab-paclitaxel in the First-line Treatment for Recurrent and Metastatic Triple Negative Breast Cancer: a Phase Ib/IIa Clinical Trial. is a phase 1/2, interventional study registered as NCT06140576 by Zhejiang Cancer Hospital, with a registry enrolment figure of 58 participants, started 2023-11-30 and due to reach its primary completion in 2025-12-31. Interventions recorded: Sindilimab; Nab-paclitaxel; Lenvatinib. Conditions listed: Breast Neoplasms. Triple-negative eligibility wording from the registry: \"According to the definition of the latest ASCO/CAP guidelines, recurrent metastatic triple negative invasive breast cancer confirmed by histopathology meets the following conditions according to recent and previous pathological results: HER2 negative: IHC 0/1+or IHC2+but ISH is negative; ER negative\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06140576","url":"https://clinicaltrials.gov/study/NCT06140576"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["nab-paclitaxel","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06140576","phase":"1/2","setting":"The Efficacy and Safety of Lenvatinib Combined With Sindilimab and Nab-paclitaxel in the First-line Treatment for Recurrent and Metastatic Triple Negative Breast Cancer: a Phase Ib/IIa Clinical Trial.","sponsor":"Zhejiang Cancer Hospital","started":"2023-11-30","startedType":"estimated","enrolled":58,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07565285","kind":"trial","name":"The Efficacy and Safety of PRTX007-003 Combined With Pembrolizumab in Resectable Stage III Melanoma","aka":["INFLECTION-003"],"tldr":"A phase 2 trial of Pembrolizumab in melanoma, run by Primmune Therapeutics, Inc., now recruiting.","summary":"The Efficacy and Safety of PRTX007-003 Combined With Pembrolizumab in Resectable Stage III Melanoma is a phase 2 interventional study registered as NCT07565285 by Primmune Therapeutics, Inc., with 48 participants planned, started 2026-07-01 and due to reach its primary completion in 2027-12. Interventions recorded: PRTX007, Pembrolizumab. Conditions listed: Melanoma Stage III. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07565285","url":"https://clinicaltrials.gov/study/NCT07565285"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","stage-iii-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","prtx007"],"companies":["primmune-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07565285","phase":"2","setting":"A Phase 2 Study to Investigate the Activity of Neoadjuvant PRTX007 Combined With Pembrolizumab in Participants With Stage III Melanoma (INFLECTION-003)","sponsor":"Primmune Therapeutics, Inc.","started":"2026-07-01","startedType":"actual","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07514533","kind":"trial","name":"The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma","aka":[],"tldr":"A phase 2 trial of pucotenlimab in gallbladder cancer and other biliary tract cancers, run by Sir Run Run Shaw Hospital, not yet recruiting.","summary":"The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma is a phase 2 interventional study registered as NCT07514533 by Sir Run Run Shaw Hospital, with a registry enrolment figure of 60 participants, started 2026-03-11 and due to reach its primary completion in 2027-12-31. Interventions recorded: Vibecototamab（iv）+Putilimab（iv）. Conditions listed: Cholangiocarcinoma. Gallbladder cancer is named in the registry entry: \"* 1\\) Age ≥ 18 years old, both male and female are acceptable. 2) Histologically confirmed unresectable or metastatic cholangiocarcinoma (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic ch\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07514533","url":"https://clinicaltrials.gov/study/NCT07514533"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pucotenlimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07514533","phase":"2","setting":"The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma","sponsor":"Sir Run Run Shaw Hospital","started":"2026-03-11","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06266832","kind":"trial","name":"The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra","aka":[],"tldr":"A phase 2 trial of adebrelimab, fOLFOX (5-FU, leucovorin, oxaliplatin) and capecitabine in colorectal cancer, run by Sir Run Run Shaw Hospital, now recruiting.","summary":"The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal Adenocarcinoma is a phase 2, interventional study registered as NCT06266832 by Sir Run Run Shaw Hospital, with a registry enrolment figure of 30 participants, started 2024-01-01 and due to reach its primary completion in 2025-01-01. Interventions recorded: Adebrelimab; Oxaliplatin; Capecitabine; Short-course Radiation; Biopsy. Conditions listed: Rectal Adenocarcinoma. Primary outcome: Organ retention rate. Colorectal eligibility wording from the registry: \"Diagnosed by digital rectal examination, colonoscopy, and high-resolution MRI of the pelvis, the tumor is less than or equal to 5 cm from the anus\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06266832","url":"https://clinicaltrials.gov/study/NCT06266832"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["adebrelimab","folfox","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06266832","phase":"2","setting":"The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal Adenocarcinoma: A Prospective, Single-arm Study","sponsor":"Sir Run Run Shaw Hospital","started":"2024-01-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06092242","kind":"trial","name":"The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of trifluridine/tipiracil and bevacizumab (glioblastoma use) in colorectal cancer, run by The Second Affiliated Hospital of Shandong First Medical University, not yet recruiting.","summary":"The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT06092242 by The Second Affiliated Hospital of Shandong First Medical University, with a registry enrolment figure of 50 participants, started 2023-10-15 and due to reach its primary completion in 2025-10-15. Interventions recorded: Tas-102(Suyuan) combined with bevacizumab. Conditions listed: Colorectal Cancer. Primary outcome: Progression Free Survival. Colorectal eligibility wording from the registry: \"Definitive histological or cytological evidence of adenocarcinoma of the colon or rectum;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06092242","url":"https://clinicaltrials.gov/study/NCT06092242"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["trifluridine-tipiracil","bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06092242","phase":"2","setting":"The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer","sponsor":"The Second Affiliated Hospital of Shandong First Medical University","started":"2023-10-15","startedType":"estimated","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07160283","kind":"trial","name":"The Efficacy and Safety of Trilaciclib in Bone Marrow Protection Before Chemotherapy for Advanced Bile Duct Cancer and Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by The Second Affiliated Hospital of Shandong First Medical University, not yet recruiting.","summary":"The Efficacy and Safety of Trilaciclib in Bone Marrow Protection Before Chemotherapy for Advanced Bile Duct Cancer and Pancreatic Cancer is a phase 2 interventional study registered as NCT07160283 by The Second Affiliated Hospital of Shandong First Medical University, with a registry enrolment figure of 96 participants, started 2025-09-01 and due to reach its primary completion in 2027-09-01. Interventions recorded: Bile duct cancer cohort, Pancreatic cancer cohort. Conditions listed: Biliary Tract Neoplasms, Pancreatic Neoplasms. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07160283","url":"https://clinicaltrials.gov/study/NCT07160283"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07160283","phase":"2","setting":"The Efficacy and Safety of Trilaciclib in Bone Marrow Protection Before Chemotherapy for Advanced Bile Duct Cancer and Pancreatic Cancer","sponsor":"The Second Affiliated Hospital of Shandong First Medical University","started":"2025-09-01","startedType":"estimated","enrolled":96,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06125080","kind":"trial","name":"The Efficacy and Safety of Utidelone Plus Tirelizumab and Bevacizumab for Advanced or Metastatic Triple-negative Breast Cancer (UTILIZABLE) ：Single-arm, Prospec","aka":["UTILIZABLE"],"tldr":"A phase 2 trial of utidelone and bevacizumab in triple-negative breast cancer, run by Huihua Xiong, now recruiting.","summary":"The Efficacy and Safety of Utidelone Plus Tirelizumab and Bevacizumab for Advanced or Metastatic Triple-negative Breast Cancer (UTILIZABLE) ：Single-arm, Prospective, Open Clinical Study is a phase 2, interventional study registered as NCT06125080 by Huihua Xiong, with a registry enrolment figure of 78 participants, started 2023-10-30 and due to reach its primary completion in 2025-10-30. Interventions recorded: Utidelone; Tirelizumab; Bevacizumab. Conditions listed: TNBC - Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Patients voluntarily participated in the study, signed the informed consent, and had good compliance; Female patients aged 18-70; TNBC confirmed by histology or cytology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06125080","url":"https://clinicaltrials.gov/study/NCT06125080"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["utidelone","bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06125080","phase":"2","setting":"The Efficacy and Safety of Utidelone Plus Tirelizumab and Bevacizumab for Advanced or Metastatic Triple-negative Breast Cancer (UTILIZABLE) ：Single-arm, Prospective, Open Clinical Study","sponsor":"Huihua Xiong","started":"2023-10-30","startedType":"estimated","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05984485","kind":"trial","name":"The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Ca","aka":["TaLaR-02"],"tldr":"A phase 3 trial in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT05984485 by Sun Yat-sen University, with a registry enrolment figure of 766 participants, started 2022-07-05 and due to reach its primary completion in 2028-07. Interventions recorded: neoadjuvant chemotherapy plus total mesorectal excision; total mesorectal excision. Conditions listed: Rectal Cancer. Primary outcome: 3-year Disease Free Survival. Colorectal eligibility wording from the registry: \"Pathologically confirmed rectal adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05984485","url":"https://clinicaltrials.gov/study/NCT05984485"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05984485","phase":"3","setting":"TME vs TME+nCT in Low-risk LARC","sponsor":"Sun Yat-sen University","started":"2022-07-05","startedType":"actual","enrolled":766,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05496166","kind":"trial","name":"The Efficiency of Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Canc","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Shanghai Pulmonary Hospital, Shanghai, China, not yet recruiting.","summary":"The Efficiency of Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT05496166 by Shanghai Pulmonary Hospital, Shanghai, China, with a registry enrolment figure of 348 participants, started 2023-08-01 and due to reach its primary completion in 2027-08-01. Interventions recorded: chemotherapy and SHR-1316(Adebrelimab) comnined with surgery or radiotherapy. Conditions listed: Limited Stage Small Cell Lung Cancer. Primary outcome: progression-free survival. Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed SCLC, imaging examination and other confirmed limited-stage small cell lung cancer, and without previous treatment;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05496166","url":"https://clinicaltrials.gov/study/NCT05496166"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["limited-stage-sclc"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05496166","phase":"3","setting":"Comparing the Efficiency Between Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer: a Randomized, Controlled, Open-label, Single-center Phase III Clinical Trial","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","started":"2023-08-01","startedType":"estimated","enrolled":348,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04585750","kind":"trial","name":"The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","aka":["PYNNACLE"],"tldr":"A phase 1/2 trial of Pembrolizumab in metastatic cancer and ovarian cancer, run by PMV Pharmaceuticals, Inc, now recruiting.","summary":"The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) is a phase 1/2 interventional study registered as NCT04585750 by PMV Pharmaceuticals, Inc, with 300 participants planned, started 2020-10-29 and due to reach its primary completion in 2026-12-15. Interventions recorded: rezatapopt, pembrolizumab. Conditions listed: Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04585750","url":"https://clinicaltrials.gov/study/NCT04585750"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","ovarian","endometrial","prostate","colorectal","endometrial-p53-abnormal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04585750-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04585750","phase":"1/2","setting":"A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","sponsor":"PMV Pharmaceuticals, Inc","started":"2020-10-29","startedType":"actual","enrolled":300,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05776381","kind":"trial","name":"The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Vejle Hospital, not yet recruiting.","summary":"The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp is a phase 2, interventional study registered as NCT05776381 by Vejle Hospital, with a registry enrolment figure of 110 participants, started 2028-02-01 and due to reach its primary completion in 2030-01-01. Interventions recorded: Shared Decision Making using a Patient Decision Aid.. Conditions listed: Shared Decision Making; Colonic Polyp; Decision Aids; Rectal Polyp; Colorectal Polyp; Colorectal Cancer. Primary outcome: Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data.. Colorectal eligibility wording from the registry: \"* Histopathologically verified malignant colorectal polyp removed endoscopically and CT-scan (and MRI if the malignant polyp was situated in the rectum) shows N0, M0 disease\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05776381","url":"https://clinicaltrials.gov/study/NCT05776381"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05776381","phase":"2","setting":"The Impact of an In-consultation Patient Decision Aid on Treatment Choices and Outcomes of Management for Patients With an Unexpected Malignant Colorectal Polyp A Non-randomized Clinical Phase II Study","sponsor":"Vejle Hospital","started":"2028-02-01","startedType":"estimated","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07114861","kind":"trial","name":"The KN510713 Study in Combination With mFOLFIRINOX","aka":[],"tldr":"A phase 1/2 trial of Study drug: KN510 120mg/day + KN713 90mg/day, Combination Chemotherapy: mFOLFIRINOX in pancreatic ductal adenocarcinoma, run by New Cancer Cure-Bio Co.,Ltd., now recruiting.","summary":"The KN510713 Study in Combination With mFOLFIRINOX is a phase 1/2 interventional study registered as NCT07114861 by New Cancer Cure-Bio Co.,Ltd., with 30 participants planned, started 2025-12-16 and due to reach its primary completion in 2028-09-22. Interventions recorded: Study drug: KN510 120mg/day + KN713 90mg/day, Combination Chemotherapy: mFOLFIRINOX and Study drug: KN510 120mg/day + KN713 120mg/day, Combination Chemotherapy: mFOLFIRINOX.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07114861","url":"https://clinicaltrials.gov/study/NCT07114861"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07114861","phase":"1/2","setting":"An Open-label, Dose-finding and Dose-expansion, Phase I/IIa Clinical Trial to Evaluate the Safety and Efficacy of KN510713 in Combination With mFOLFIRINOX in Patients With Locally Advanced or Metastatic Pancreatic Cancer","sponsor":"New Cancer Cure-Bio Co.,Ltd.","started":"2025-12-16","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06843551","kind":"trial","name":"The Miami \"EMPIRE\" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation","aka":["EMPIRE"],"tldr":"A phase 2 trial of botensilimab and balstilimab in pancreatic cancer, run by Benjamin Spieler, now recruiting.","summary":"The Miami \"EMPIRE\" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation is a phase 2, interventional study registered as NCT06843551 by Benjamin Spieler, with a registry enrolment figure of 20 participants, started 2025-06-18 and due to reach its primary completion in 2030-08-01. Interventions recorded: Stereotactic Body Radiation Therapy; Botensilimab; Balstilimab. Conditions listed: Metastatic Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Cancer. Primary outcome: Clinical Benefit Rate (CBR). Pancreatic eligibility wording from the registry: \"Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06843551","url":"https://clinicaltrials.gov/study/NCT06843551"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":["botensilimab","balstilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06843551","phase":"2","setting":"A Phase 2 Single Arm Trial of Stereotactic Body Radiation Therapy Followed by Dual Immune Checkpoint Inhibition for Patients With Metastatic Pancreatic Ductal Adenocarcinoma - The Miami \"EMPIRE\" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation","sponsor":"Benjamin Spieler","started":"2025-06-18","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04329728","kind":"trial","name":"The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies","aka":["OPAL"],"tldr":"A phase 1/2 trial of AVM0703 in advanced solid tumours, run by AVM Biotechnology Inc, now recruiting.","summary":"The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies is a phase 1/2 interventional study registered as NCT04329728 by AVM Biotechnology Inc, with 144 participants planned, started 2020-11-06 and due to reach its primary completion in 2027-11-30. Interventions recorded: AVM0703.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04329728","url":"https://clinicaltrials.gov/study/NCT04329728"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["medpace"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04329728","phase":"1/2","setting":"An Open Label, Phase 1/2 Study Evaluating Immunomodulatory AVM0703 in Patients With Lymphoid Malignancies (OPAL Study)","sponsor":"AVM Biotechnology Inc","started":"2020-11-06","startedType":"actual","enrolled":144,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06735131","kind":"trial","name":"The Optimal Radioimmunotherapy Combinations for Advanced TNBC","aka":[],"tldr":"A phase 2 trial of toripalimab in triple-negative breast cancer, run by Sun Yat-sen University, now recruiting.","summary":"The Optimal Radioimmunotherapy Combinations for Advanced TNBC is a phase 2, interventional study registered as NCT06735131 by Sun Yat-sen University, with a registry enrolment figure of 60 participants, started 2024-12-20 and due to reach its primary completion in 2026-07. Interventions recorded: radiotherapy 5 Gy × 5 fractions, once a day; radiotherapy 8 Gy × 5 fractions, once a day; radiotherapy 8 Gy × 3 fractions, once every other day; radiotherapy 10 Gy× 3 fractions, once every other day; radiotehrapy 0.5Gy twice-a-day × 2 days, repeat for 4 cycles (total 8Gy); Toripalimab; chemotherapy regimen selected by the investigator. Conditions listed: Triple-Negative Breast Cancer (TNBC). Triple-negative eligibility wording from the registry: \"Inoperable locally advanced/metastatic triple-negative breast cancer (defined as ER and PR \\<1%; and HER2 negative as IHC 0 or IHC 1+, or IHC 2+ but negative upon fluorescence in situ hybridization (FISH) testing)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06735131","url":"https://clinicaltrials.gov/study/NCT06735131"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06735131","phase":"2","setting":"A Prospective, Multicenter Clinical Trial Exploring the Optimal Combination Strategies of Radiotherapy and Immunotherapy for Advanced Triple-Negative Breast Cancer","sponsor":"Sun Yat-sen University","started":"2024-12-20","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07204574","kind":"trial","name":"The Phase 1b/IIa, Open-label, Dose Escalation and Dose Expansion to Evaluate Safety, Tolerability, and Preliminary Efficacy of the Combination of HCB101, Cetuxi","aka":[],"tldr":"A phase 1/2 trial of bevacizumab (glioblastoma use), cetuximab and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Chang Gung Memorial Hospital, now recruiting.","summary":"The Phase 1b/IIa, Open-label, Dose Escalation and Dose Expansion to Evaluate Safety, Tolerability, and Preliminary Efficacy of the Combination of HCB101, Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI in Advanced or Metastatic Colorectal Cancer is a phase 1/2, interventional study registered as NCT07204574 by Chang Gung Memorial Hospital, with a registry enrolment figure of 40 participants, started 2025-05-14 and due to reach its primary completion in 2025-12-31. Interventions recorded: HCB101; Bevacizumab; Cetuximab (Erbitux); FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan); FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil). Conditions listed: CRC. Primary outcome: Number of subjects with MTD of HCB101 in combination with Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI; Overall Rate Response (ORR). Colorectal eligibility wording from the registry: \"With histologically/cytologically confirmed diagnosis of unresectable locally advanced or metastatic colorectal cancer, with both RAS and BRAF wild-type, who have experienced treatment failure with prior chemotherapy for locally advanced or metastatic disease (intended for second-line treatment)\". Sites: Taiwan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07204574","url":"https://clinicaltrials.gov/study/NCT07204574"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","platinum"],"targets":[],"drugs":["bevacizumab-glioma","cetuximab","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07204574","phase":"1/2","setting":"The Phase 1b/IIa, Open-label, Dose Escalation and Dose Expansion to Evaluate Safety, Tolerability, and Preliminary Efficacy of the Combination of HCB101, Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI in Advanced or Metastatic Colorectal Cancer","sponsor":"Chang Gung Memorial Hospital","started":"2025-05-14","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06115499","kind":"trial","name":"The PLATINUM Trial: Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA1/2 or PALB2-Associated Metastatic Pancreatic Cancer","aka":["PLATINUM"],"tldr":"A phase 2/3 trial of nab-paclitaxel, gemcitabine and cisplatin in pancreatic cancer, run by Alliance for Clinical Trials in Oncology, active but no longer recruiting.","summary":"The PLATINUM Trial: Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA1/2 or PALB2-Associated Metastatic Pancreatic Cancer is a phase 2/3, randomised interventional study registered as NCT06115499 by Alliance for Clinical Trials in Oncology, with a registry enrolment figure of 10 participants, started 2024-08-13 and due to reach its primary completion in 2029-01-15. Interventions recorded: Nab paclitaxel; Gemcitabine; Cisplatin; Magnetic Resonance Imaging; Computed Tomography; Biospecimen Collection. Conditions listed: Pancreatic Acinar Cell Carcinoma; Pancreatic Adenocarcinoma; Pancreatic Adenosquamous Carcinoma; Pancreatic Carcinoma; Pancreatic Ductal Adenocarcinoma; Pancreatic Squamous Cell Carcinoma; Stage IV Pancreatic Cancer AJCC v8. Primary outcome: Overall response rate (ORR) (Phase II); Overall Survival (OS) (Phase III). Pancreatic eligibility wording from the registry: \"* Metastatic pancreatic adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06115499","url":"https://clinicaltrials.gov/study/NCT06115499"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac","brca-palb2-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["nab-paclitaxel","gemcitabine","cisplatin"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06115499","phase":"2/3","setting":"Phase II/III Second-Line NABPLAGEM vs. Nab-Paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Mutant Metastatic Pancreatic Ductal Adenocarcinoma (PLATINUM)","sponsor":"Alliance for Clinical Trials in Oncology","started":"2024-08-13","startedType":"actual","enrolled":10,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05624138","kind":"trial","name":"The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by Tanta University, now recruiting.","summary":"The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy is a phase 3, randomised interventional study registered as NCT05624138 by Tanta University, with a registry enrolment figure of 64 participants, started 2022-11-09 and due to reach its primary completion in 2024-04-04. Interventions recorded: Placebo tablets; Ketotifen Oral Tablet. Conditions listed: Neuropathy;Peripheral. Primary outcome: variation in 12-item neurotoxicity questionnaire (Ntx-12) total score; variation in pain rating scale score; the percentage of patients with peripheral sensory neuropathy grade ≥ 2. Colorectal eligibility wording from the registry: \"* Patients with histologically confirmed diagnosis of Stage III colorectal cancer\". Sites: Egypt. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05624138","url":"https://clinicaltrials.gov/study/NCT05624138"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05624138","phase":"3","setting":"The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer","sponsor":"Tanta University","started":"2022-11-09","startedType":"actual","enrolled":64,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02653755","kind":"trial","name":"The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer","aka":[],"tldr":"A phase 2 trial of Prosigna in Breast cancer, run by Dana-Farber Cancer Institute, active and no longer recruiting.","summary":"The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer is a phase 2 interventional study registered as NCT02653755 by Dana-Farber Cancer Institute, with 671 participants planned, started 2015-12-15 and due to reach its primary completion in 2030-05-15. Interventions recorded: Prosigna. Conditions recorded: Breast Cancer Radiation.\n\nLinked to the drug Prosigna because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02653755","url":"https://clinicaltrials.gov/study/NCT02653755"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["prosigna"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02653755","phase":"2","setting":"The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer","sponsor":"Dana-Farber Cancer Institute","started":"2015-12-15","startedType":"actual","enrolled":671,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06370416","kind":"trial","name":"the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib","aka":[],"tldr":"A phase 2 trial of trilaciclib in lung cancer, run by Henan Cancer Hospital, now recruiting.","summary":"the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib is a phase 2, interventional study registered as NCT06370416 by Henan Cancer Hospital, with a registry enrolment figure of 41 participants, started 2024-04-02 and due to reach its primary completion in 2026-01-30. Interventions recorded: Trilaciclib. Conditions listed: Non-small Cell Lung Cancer. Primary outcome: The incidence of grade ≥ 3 neutropenia during chemotherapy treatment. Lung eligibility wording from the registry: \"* Patients with locally advanced and late stage (IIIB, IIIC, IV) NSCLC who have been confirmed by histopathology and cannot be surgically removed (without local symptoms (with or without brain metastasis)) have at least one measurable lesion that meets the RECIST 1\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06370416","url":"https://clinicaltrials.gov/study/NCT06370416"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["trilaciclib"],"companies":["simcere"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06370416","phase":"2","setting":"A Single Arm, Exploratory Clinical Study on the Prevention of Bone Marrow Suppression Caused by Platinum Containing Chemotherapy in Advanced Non-small Cell Lung Cancer With Trilaciclib","sponsor":"Henan Cancer Hospital","started":"2024-04-02","startedType":"actual","enrolled":41,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05422690","kind":"trial","name":"The Purpose of This Research Study is to See if Combining Gemcitabine, Cisplatin and Durvalumab Chemotherapy Treatments With a Direct Tumor Therapy Yittrium-90 (Y-90) Will Work Better Together to Shrink Tumors and Control Cancer","aka":[],"tldr":"A phase 2 trial of durvalumab, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by Inova Health Care Services, now recruiting.","summary":"The Purpose of This Research Study is to See if Combining Gemcitabine, Cisplatin and Durvalumab Chemotherapy Treatments With a Direct Tumor Therapy Yittrium-90 (Y-90) Will Work Better Together to Shrink Tumors and Control Cancer is a phase 2 interventional study registered as NCT05422690 by Inova Health Care Services, with a registry enrolment figure of 16 participants, started 2024-06-12 and due to reach its primary completion in 2027-03-30. Interventions recorded: Induction Chemotherapy Triplet Therapy, Concurrent Y-90 treatment, Consolidation Doublet Therapy:. Conditions listed: Intrahepatic Cholangiocarcinoma. Gallbladder cancer is named in the registry entry: \"* Gallbladder cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05422690","url":"https://clinicaltrials.gov/study/NCT05422690"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["durvalumab","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05422690","phase":"2","setting":"A Phase II Single-center, Open-label, Single Arm Study of Induction Gemcitabine, Cisplatin and Durvalumab Followed by Gemcitabine, Cisplatin and Yttrium-90 (Y-90) Radioembolization for the Treatment of Locally Advanced Unresectable Intrahepatic Cholangiocarcinoma","sponsor":"Inova Health Care Services","started":"2024-06-12","startedType":"actual","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04781192","kind":"trial","name":"The Purpose of This Trial is to Determine if Regorafenib Plus Durvalumab (MEDI4736) is Safe and Effective in Treatment of Chemo Refractory Advanced Biliary Tract Cancers","aka":[],"tldr":"A phase 1/2 trial of durvalumab and regorafenib in gallbladder cancer and other biliary tract cancers, run by University of Kansas Medical Center, active and no longer recruiting.","summary":"The Purpose of This Trial is to Determine if Regorafenib Plus Durvalumab (MEDI4736) is Safe and Effective in Treatment of Chemo Refractory Advanced Biliary Tract Cancers is a phase 1/2 interventional study registered as NCT04781192 by University of Kansas Medical Center, with a registry enrolment figure of 40 participants, started 2022-03-22 and due to reach its primary completion in 2025-11-12. Interventions recorded: Durvalumab, Regorafenib. Conditions listed: Advanced Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: \"* Histologically confirmed unresectable or metastatic intrahepatic/extrahepatic cholangiocarcinoma or gallbladder cancer with radiographic progression, who have progressed on one line of therapy / failed adjuvant therapy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04781192","url":"https://clinicaltrials.gov/study/NCT04781192"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["durvalumab","regorafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04781192","phase":"1/2","setting":"Phase I/II Clinical Trial of Regorafenib Plus Durvalumab (MEDI4736) in Patients With Chemo Refractory Advanced Biliary Tract Cancers","sponsor":"University of Kansas Medical Center","started":"2022-03-22","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05550415","kind":"trial","name":"The Role of Simvastatin in The Epithelial-Mesenchymal Transition Process of Breast Cancer","aka":[],"tldr":"A phase 2 trial in triple-negative breast cancer, run by Universitas Indonesia, now recruiting.","summary":"The Role of Simvastatin in The Epithelial-Mesenchymal Transition Process of Breast Cancer is a phase 2, randomised interventional study registered as NCT05550415 by Universitas Indonesia, with a registry enrolment figure of 26 participants, started 2022-08-19 and due to reach its primary completion in 2026-11. Interventions recorded: Simvastatin 40mg; Placebo. Conditions listed: Triple Negative Breast Cancer; Chemotherapy Effect; Simvastatin Adverse Reaction. Triple-negative eligibility wording from the registry: \"Female patients with advanced breast cancer (locally advanced and distantly advanced) with triple-negative molecular type confirmed by biopsy and immunohistochemical examination\". Sites: Indonesia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05550415","url":"https://clinicaltrials.gov/study/NCT05550415"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05550415","phase":"2","setting":"Vimentin Expression-based Therapeutic Response in Triple Negative Breast Cancer Receiving Combination of Simvastatin and NAC: A Randomized, Double-Blind, Placebo-Controlled Trial","sponsor":"Universitas Indonesia","started":"2022-08-19","startedType":"actual","enrolled":26,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06946901","kind":"trial","name":"The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a","aka":[],"tldr":"A phase 2 trial of cisplatin in pancreatic cancer, run by Shanghai Zhongshan Hospital, now recruiting.","summary":"The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a Phase II Clinical Trial is a phase 2, interventional study registered as NCT06946901 by Shanghai Zhongshan Hospital, with a registry enrolment figure of 90 participants, started 2025-04-03 and due to reach its primary completion in 2026-04-03. Interventions recorded: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy. Conditions listed: Hyperthermic Intraperitoneal Chemotherapy; Peritoneal Metastatic Pancreatic Cancer. Primary outcome: 1-year Overall Survival (OS) Rate. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06946901","url":"https://clinicaltrials.gov/study/NCT06946901"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06946901","phase":"2","setting":"The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a Phase II Clinical Trial","sponsor":"Shanghai Zhongshan Hospital","started":"2025-04-03","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07109167","kind":"trial","name":"The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors","aka":[],"tldr":"A phase 2 trial of benmelstobart, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by The Second Affiliated Hospital of Shandong First Medical University, not yet recruiting.","summary":"The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors is a phase 2 interventional study registered as NCT07109167 by The Second Affiliated Hospital of Shandong First Medical University, with a registry enrolment figure of 30 participants, started 2025-08-01 and due to reach its primary completion in 2026-08-01. Interventions recorded: Benmelstobart combined with gemcitabine and cisplatin. Conditions listed: Biliary Tract Neoplasms. Gallbladder cancer is named in the registry entry: \"Age: 18 to 75 years old, inclusive; of either sex. Histopathologically confirmed unresectable and previously untreated gallbladder cancer or intrahepatic/extrahepatic cholangiocarcinoma, with at least one measurable lesi\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07109167","url":"https://clinicaltrials.gov/study/NCT07109167"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["benmelstobart","gemcitabine","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07109167","phase":"2","setting":"The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors","sponsor":"The Second Affiliated Hospital of Shandong First Medical University","started":"2025-08-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07257653","kind":"trial","name":"The Safety and Efficacy of Cetuximab Beta Plus Fruquintinib With or Without Immune Checkpoint Inhibitorrs in First-line Treatment of RAS/BRAF Wild Type Unresect","aka":["concept"],"tldr":"A phase 2 trial in colorectal cancer, run by Zhejiang University, now recruiting.","summary":"The Safety and Efficacy of Cetuximab Beta Plus Fruquintinib With or Without Immune Checkpoint Inhibitorrs in First-line Treatment of RAS/BRAF Wild Type Unresectable Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07257653 by Zhejiang University, with a registry enrolment figure of 70 participants, started 2025-10-21 and due to reach its primary completion in 2026-12-31. Interventions recorded: Cetuximab β；Fruquintinib；; Cetuximab β；Fruquintinib；anti-PD1 antibody；; Cetuximab β；Fruquintinib；anti-PD1/CTLA4 antibody. Conditions listed: Colorectal Neoplasms; RAS; BRAF; Cetuximabβ; Fruquintinib. Primary outcome: PFS. Colorectal eligibility wording from the registry: \"For patients aged 80-85, comprehensive functional assessments must be completed, and they may be enrolled if the investigator deems them tolerable, with an expected survival of over 3 months; 3) Histopathologically and/or cytologically confirmed, unresectable metastatic colorectal adenocarcinoma con\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07257653","url":"https://clinicaltrials.gov/study/NCT07257653"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07257653","phase":"2","setting":"The Safety and Efficacy of Cetuximab Beta Plus Fruquintinib With or Without Immune Checkpoint Inhibitorrs in First-line Treatment of RAS/BRAF Wild Type Unresectable Metastatic Colorectal Cancer","sponsor":"Zhejiang University","started":"2025-10-21","startedType":"actual","enrolled":70,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06490536","kind":"trial","name":"The Sagittarius Trial","aka":[],"tldr":"A phase 3 trial of fOLFOX (5-FU, leucovorin, oxaliplatin), capecitabine, leucovorin (folinic acid), fluorouracil (5-FU) and other drugs in colorectal cancer, run by IFOM ETS - The AIRC Institute of Molecular Oncology, now recruiting.","summary":"The Sagittarius Trial is a phase 3, randomised interventional study registered as NCT06490536 by IFOM ETS - The AIRC Institute of Molecular Oncology, with a registry enrolment figure of 700 participants, started 2024-10-22 and due to reach its primary completion in 2026-03-01. Interventions recorded: Oxaliplatin; Capecitabine; Folinic acid; Fluorouracil; Temozolomide; Irinotecan; Nivolumab; Ipilimumab; Trastuzumab; Pertuzumab; Panitumumab. Conditions listed: Colon Cancer Stage II; Colon Cancer Stage III. Primary outcome: 2-Year Recurrence-Free Survival (RFS). Sites: Germany, Italy, Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06490536","url":"https://clinicaltrials.gov/study/NCT06490536"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","monoclonal-antibody","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfox","capecitabine","leucovorin","fluorouracil","temozolomide","folfiri","nivolumab","ipilimumab","trastuzumab","pertuzumab","panitumumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06490536","phase":"3","setting":"A Precision Medicine Trial Leveraging Blood-Based Tumor Genomics to Optimize Treatment in Operable Stage III and High-Risk Stage II Colon Cancer Patients","sponsor":"IFOM ETS - The AIRC Institute of Molecular Oncology","started":"2024-10-22","startedType":"actual","enrolled":700,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07146230","kind":"trial","name":"The Selective Personalized Radio-Immunotherapy for Locally Advanced Non-Small Cell Lung Cancer Trial 2","aka":["SPRINT 2"],"tldr":"A phase 2 trial of durvalumab, monalizumab and oleclumab in lung cancer, run by Montefiore Medical Center, not yet recruiting.","summary":"The Selective Personalized Radio-Immunotherapy for Locally Advanced Non-Small Cell Lung Cancer Trial 2 is a phase 2, randomised interventional study registered as NCT07146230 by Montefiore Medical Center, with a registry enrolment figure of 52 participants, started 2026-09 and due to reach its primary completion in 2028-04. Interventions recorded: Durvalumab; Monalizumab; Oleclumab; Radiotherapy. Conditions listed: Non-small Cell Lung Cancer. Primary outcome: Response rate observed using FDG-PET imaging. Lung eligibility wording from the registry: \"Previously untreated, pathologically proven NSCLC and one of the following stages:\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07146230","url":"https://clinicaltrials.gov/study/NCT07146230"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["durvalumab","monalizumab","oleclumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07146230","phase":"2","setting":"The Selective Personalized Radio-Immunotherapy for Locally Advanced NSCLC Trial 2 (SPRINT 2)","sponsor":"Montefiore Medical Center","started":"2026-09","startedType":"estimated","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04233346","kind":"trial","name":"The Study for CML Who Failed Prior TKIs or With T315I Mutation or Ph+ ALL Who Failed Prior TKIs or With T315I Mutation","aka":[],"tldr":"A phase 2 trial of Ponatinib in chronic myeloid leukaemia and acute lymphoblastic leukaemia, run by Otsuka Beijing Research Institute, active and no longer recruiting.","summary":"The Study for CML Who Failed Prior TKIs or With T315I Mutation or Ph+ ALL Who Failed Prior TKIs or With T315I Mutation is a phase 2 interventional study registered as NCT04233346 by Otsuka Beijing Research Institute, with 93 participants enrolled, started 2020-07-09 and due to reach its primary completion in 2022-07-22. Interventions recorded: Ponatinib 30mg OD and Ponatinib 45mg OD.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04233346","url":"https://clinicaltrials.gov/study/NCT04233346"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cml","all-leukemia","cml-advanced-phase"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["ponatinib"],"companies":["otsuka"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04233346","phase":"2","setting":"A Phase II Multi-center, Randomized, Open-label Study of Ponatinib in Chinese Patients With Chronic Myeloid Leukemia Who Have Failed Prior TKIs or With T315I Mutation, or Ph+ALL Who Have Failed Prior TKIs or With T315I Mutation","sponsor":"Otsuka Beijing Research Institute","started":"2020-07-09","startedType":"actual","enrolled":93,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06520345","kind":"trial","name":"The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)","aka":[],"tldr":"A phase 3 trial of FAP-2286, Enzalutamide, Abiraterone acetate in prostate cancer, run by Telix Pharmaceuticals (Innovations) Pty Limited, now recruiting.","summary":"The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global) is a phase 3 interventional study registered as NCT06520345 by Telix Pharmaceuticals (Innovations) Pty Limited, with 520 participants planned, started 2024-07-26 and due to reach its primary completion in 2027-12. Interventions recorded: 177Lu-TLX591, Enzalutamide, Abiraterone, Docetaxel. Conditions listed: Metastatic Castration-resistant Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06520345","url":"https://clinicaltrials.gov/study/NCT06520345"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["fap-2286","enzalutamide","abiraterone","docetaxel"],"companies":["telix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06520345","phase":"3","setting":"A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination With Standard of Care Versus Standard of Care Alone in Patients With PSMA Positive Metastatic Castration-Resistant Prostate Cancer Previously After Androgen Receptor Pathway Inhibitor Treatment","sponsor":"Telix Pharmaceuticals (Innovations) Pty Limited","started":"2024-07-26","startedType":"actual","enrolled":520,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07134205","kind":"trial","name":"The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 3 trial of JMT101, fOLFIRI (5-FU, leucovorin, irinotecan) and regorafenib in colorectal cancer, run by Shanghai JMT-Bio Inc., not yet recruiting.","summary":"The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT07134205 by Shanghai JMT-Bio Inc., with a registry enrolment figure of 252 participants, started 2025-10-01 and due to reach its primary completion in 2027-06-01. Interventions recorded: JMT101; Irinotecan; Regorafenib. Conditions listed: Metastatic Colorectal Cancer (mCRC). Primary outcome: Progression-free Survival (PFS). Colorectal eligibility wording from the registry: \"Pathological diagnosis as metastatic colorectal adenocarcinoma, with RAS and BRAF wild-type and non-dMMR/MSI-H;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07134205","url":"https://clinicaltrials.gov/study/NCT07134205"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy","kinase-inhibitors","topoisomerase-inhibitors"],"targets":[],"drugs":["jmt101","folfiri","regorafenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07134205","phase":"3","setting":"A Randomized, Open-label, Multicenter Phase III Clinical Study of JMT101 in Combination With Irinotecan in Third-line and Beyond Treatment of Metastatic Colorectal Cancer","sponsor":"Shanghai JMT-Bio Inc.","started":"2025-10-01","startedType":"estimated","enrolled":252,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05862610","kind":"trial","name":"The Study of Trilaciclib Combined With Chemotherapy On The Neoadjuvant Therapy of TNBC","aka":[],"tldr":"A phase 2 trial of trilaciclib in triple-negative breast cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, not yet recruiting.","summary":"The Study of Trilaciclib Combined With Chemotherapy On The Neoadjuvant Therapy of TNBC is a phase 2, randomised interventional study registered as NCT05862610 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, with a registry enrolment figure of 150 participants, started 2023-07-30 and due to reach its primary completion in 2026-12-30. Interventions recorded: Trilaciclib plus chemotherapy; Chemotherapy. Conditions listed: Breast Neoplasm. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05862610","url":"https://clinicaltrials.gov/study/NCT05862610"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":["trilaciclib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05862610","phase":"2","setting":"A Prospective, Randomized, Controlled Phase II Clinical Study of Trilaciclib Combined With Standard Treatment Project As a Neoadjuvant Treatment For Triple Negative Breast Cancer","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","started":"2023-07-30","startedType":"estimated","enrolled":150,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04871412","kind":"trial","name":"The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage III","aka":["POISE"],"tldr":"A phase 3 trial in lung cancer, run by Ottawa Hospital Research Institute, now recruiting.","summary":"The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage III is a phase 3, randomised interventional study registered as NCT04871412 by Ottawa Hospital Research Institute, with a registry enrolment figure of 20 participants, started 2022-04-04 and due to reach its primary completion in 2028-12-01. Interventions recorded: Vitamin D3 Drops; Coriolus Versicolor; Trident SAP 66:33 Lemon; Probiotic Pro12; Provitalix Pure Whey Protein; Theracurmin 2X; Green Tea Extract; Nutrition Recommendations; Physical Activity Recommendations; Psychological Recommendations. Conditions listed: Lung Cancer; Gastric Cancer; Esophageal Cancer. Primary outcome: Participant Recruitment Rates; Participant Retention Rates; Cross-over and contamination in the control arm - Supplement usage. Lung eligibility wording from the registry: \"• Adults eligible for complete resection of lung, gastric or esophageal cancer\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04871412","url":"https://clinicaltrials.gov/study/NCT04871412"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04871412","phase":"3","setting":"Pioneering Pre- and Post-Operative Integrative Care to Improve Thoracic Cancer Quality of Care - The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial - Stage III","sponsor":"Ottawa Hospital Research Institute","started":"2022-04-04","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06845306","kind":"trial","name":"The Use of Indocyanine Green Near-infrared Fluorescence for Bowel Perfusion Quantitative Assessment in Order to Prevent Anastomotic Leakage in Colorectal Surger","aka":["ICG-NIRF"],"tldr":"A phase 3 trial in colorectal cancer, run by Vadim Kuznetsov, not yet recruiting.","summary":"The Use of Indocyanine Green Near-infrared Fluorescence for Bowel Perfusion Quantitative Assessment in Order to Prevent Anastomotic Leakage in Colorectal Surgery is a phase 3, randomised interventional study registered as NCT06845306 by Vadim Kuznetsov, with a registry enrolment figure of 1268 participants, started 2025-06-01 and due to reach its primary completion in 2026-07-01. Interventions recorded: ICG-guided bowel perfusion assessment; Conventional Bowel Anastomosis group. Conditions listed: Colo-rectal Cancer; Colonic Neoplasms Malignant. Primary outcome: 30-days Anastomotic Leakage (AL) rate. Colorectal eligibility wording from the registry: \"* histologically confirmed neoplasms malignant of the colon (caecum, ascending, transverse, descending, sigmoid)\". Sites: Russia. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06845306","url":"https://clinicaltrials.gov/study/NCT06845306"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06845306","phase":"3","setting":"Indocyanine Green Near-infrared Fluorescence Bowel Perfusion Quantitative Assessment to Prevent Anastomotic Leakage in Colorectal Surgery: a Multicentre, Randomised, Controlled Study","sponsor":"Vadim Kuznetsov","started":"2025-06-01","startedType":"estimated","enrolled":1268,"enrolledBasis":"registry","outcomes":[]},{"id":"therap","kind":"trial","name":"TheraP (ANZUP 1603)","aka":[],"tldr":"The randomised trial that first pitted a radioligand against chemotherapy and won on response, with fewer side effects.","summary":"TheraP, ANZUP trial 1603, NCT03392428, sponsored by ANZUP and Peter MacCallum and reported in 2021, was the randomised phase 2 that first pitted a radioligand against chemotherapy, comparing 177Lu-PSMA-617 with cabazitaxel in metastatic castration-resistant prostate cancer after docetaxel, with patients selected by PSMA and FDG PET. It randomised 200 men, met its primary endpoint with a PSA response of at least fifty percent in 66 percent of men against 37 percent, delayed progression and gave better quality of life with fewer side effects, but overall survival was similar in the 2024 analysis after crossover. OnCo links it to radioligand therapy, PSMA PET, lutetium-177 vipivotide tetraxetan, cabazitaxel, Michael Hofman and the PSA50 term, and it is consistent with VISION on activity. The survival equivalence with cabazitaxel is the nuance that matters for sequencing, which remains open.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT03392428","url":"https://clinicaltrials.gov/study/NCT03392428"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["radioligand-therapy","psma-pet"],"targets":[],"drugs":["pluvicto","cabazitaxel"],"companies":["anzup"],"institutions":["peter-mac"],"pathways":[],"terms":["psa50","prostate-crpc-sequencing"],"trials":["vision","card","psmafore"],"people":["hofman-michael"],"bottlenecks":[],"keyPapers":["paper-therap-lancet-2021","paper-therap-lancet-oncol-2024-update"],"journals":[],"dependsOn":[],"notes":["TheraP is the only randomised comparison of a PSMA radioligand against an active chemotherapy comparator rather than against best supportive care or an androgen receptor pathway inhibitor switch, which makes it the trial to cite when the question is whether the radioligand is better than the alternative rather than better than nothing. Men were selected by both PSMA PET and FDG PET, so its population is more tightly defined than VISION's."],"nct":"NCT03392428","phase":"2","setting":"mCRPC after docetaxel: 177Lu-PSMA-617 vs cabazitaxel, PSMA PET/FDG PET selected","sponsor":"ANZUP / Peter MacCallum","result":"PSA50 66% vs 37%; OS HR 0.97.","started":"2018-01-29","startedType":"actual","yearReported":2021,"enrolled":201,"enrolledBasis":"registry","outcomes":[{"endpoint":"PSA response ≥50%","primary":true,"unit":"%","arms":[{"name":"177Lu-PSMA-617","n":99,"value":66},{"name":"Cabazitaxel","n":101,"value":37}],"p":"<0.0001","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00237-3/fulltext"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"177Lu-PSMA-617","value":19.1,"note":"Not different"},{"name":"Cabazitaxel","value":19.6}],"hr":0.97,"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00529-6/fulltext"}],"replication":"Consistent with VISION on activity; the OS equivalence with cabazitaxel is an important nuance for sequencing."},{"id":"nct05771584","kind":"trial","name":"Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer","aka":["CORNERSTONE-003"],"tldr":"A phase 2 trial of AST-301 in gastric & gastro-oesophageal junction cancer, run by Aston Sci. Inc., active and no longer recruiting.","summary":"Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer is a phase 2 interventional study registered as NCT05771584 by Aston Sci. Inc., with 24 participants enrolled, started 2023-07-04 and due to reach its primary completion in 2027-02-09. Interventions recorded: AST-301 and rhuGM-CSF.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05771584","url":"https://clinicaltrials.gov/study/NCT05771584"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":[],"targets":["her2"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05771584","phase":"2","setting":"A Phase 2 Study to Evaluate the Safety and Immunological Efficacy of Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With HER2 Expressing Gastric Cancer (CORNERSTONE-003)","sponsor":"Aston Sci. Inc.","started":"2023-07-04","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01700946","kind":"trial","name":"Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma","aka":[],"tldr":"A phase 2 trial of Dexamethasone, Vincristine, Rituximab, Clofarabine, Cyclophosphamide, Etoposide, Aldesleukin, Asparaginase, Methotrexate, Mercaptopurine, Cytarabine, Mitoxantrone, Teniposide and Vinblastine in Acute lymphoblastic leukaemia, run by St. Jude Children's Research Hospital, completed.","summary":"Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma is a phase 2 interventional study registered as NCT01700946 by St. Jude Children's Research Hospital, with 80 participants recorded, started 2013-04-15 and reaching its primary completion in 2021-07-24. Interventions recorded: dexamethasone, vincristine sulfate, rituximab, clofarabine, cyclophosphamide, etoposide, aldesleukin, pegaspargase, methotrexate, mercaptopurine, cytarabine, mitoxantrone, teniposide, vinblastine, natural killer cell infusion, laboratory biomarker analysis, therapeutic hydrocortisone, allogeneic hematopoietic stem cell transplantation, CliniMACS. Conditions recorded: Recurrent B-Cell Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood B-Lymphoblastic Lymphoma.\n\nLinked to the drug Teniposide because the registry names it among its interventions and Acute lymphoblastic leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01700946","url":"https://clinicaltrials.gov/study/NCT01700946"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","all-paediatric-relapsed"],"sections":[],"technologies":[],"targets":[],"drugs":["dexamethasone","vincristine","rituximab","clofarabine","cyclophosphamide","etoposide","aldesleukin","asparaginase","methotrexate","mercaptopurine","cytarabine","mitoxantrone","teniposide","vinblastine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01700946","phase":"2","setting":"A Phase II Study of Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma","sponsor":"St. Jude Children's Research Hospital","started":"2013-04-15","startedType":"actual","yearReported":2022,"enrolled":80,"enrolledBasis":"registry","outcomes":[{"endpoint":"3-year Overall Survival Rate of Patients With Relapsed ALL","primary":true,"unit":"%","arms":[{"name":"STANDARD RISK","n":18,"value":94.4,"note":"95% CI 66.6 to 99.2; Figures from the ClinicalTrials.gov results section (first posted 2022-09-28), not from a publication"},{"name":"HIGH RISK","n":24,"value":55.5,"note":"95% CI 33.0 to 73.2"},{"name":"All Patients Enrolled on the Study","n":42,"value":72.63,"note":"95% CI 55.95 to 83.85"}],"source":"https://clinicaltrials.gov/study/NCT01700946?tab=results"},{"endpoint":"3-year Event-free Survival Rates in Patients With Relapsed ALL","primary":true,"unit":"%","arms":[{"name":"STANDARD RISK","n":18,"value":83.3,"note":"95% CI 56.8 to 94.3; Figures from the ClinicalTrials.gov results section (first posted 2022-09-28), not from a publication"},{"name":"HIGH RISK","n":24,"value":55.7,"note":"95% CI 33.2 to 73.4"},{"name":"All Patients Enrolled on the Study","n":42,"value":67.83,"note":"95% CI 51.04 to 79.9"}],"source":"https://clinicaltrials.gov/study/NCT01700946?tab=results"}]},{"id":"nct05063565","kind":"trial","name":"TheraSphere With Durvalumab and Tremelimumab for HCC","aka":["ROWAN"],"tldr":"A phase 2 trial of Durvalumab in hepatocellular carcinoma, run by Boston Scientific Corporation, active and no longer recruiting.","summary":"TheraSphere With Durvalumab and Tremelimumab for HCC is a phase 2 interventional study registered as NCT05063565 by Boston Scientific Corporation, with 100 participants planned, started 2023-11-03 and due to reach its primary completion in 2027-06. Interventions recorded: TheraSphere Y-90 glass microsphere therapy, Durvalumab (Imfinzi) immunotherapy, Tremelimumab immunotherapy. Conditions listed: Hepatocellular Carcinoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05063565","url":"https://clinicaltrials.gov/study/NCT05063565"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab"],"companies":["boston-scientific"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05063565","phase":"2","setting":"An Open-Label, Prospective, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of TheraSphere™ Followed by Durvalumab (Imfinzi®) With Tremelimumab (Imjudo®) for Hepatocellular Carcinoma (HCC)","sponsor":"Boston Scientific Corporation","started":"2023-11-03","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04665609","kind":"trial","name":"Thermal Ablation Combined With Anlotinib and TQB2450 Solution for HCC","aka":[],"tldr":"A phase 3 trial of Thermal ablation in Hepatocellular carcinoma, run by Chinese PLA General Hospital, with a status the registry has not verified recently.","summary":"Thermal Ablation Combined With Anlotinib and TQB2450 Solution for HCC is a phase 3 interventional study registered as NCT04665609 by Chinese PLA General Hospital, with 80 participants planned, started 2021-03-05 and due to reach its primary completion in 2022-12-31. Interventions recorded: Anlotinib and TQB2450 solution, TQB2450 solution. Conditions recorded: Hepatocellular Carcinoma, Thermal Ablation, Anlotinib, PDL-1.\n\nLinked to the technology Thermal ablation because the registry's title names it (\"thermal ablation\") and Hepatocellular carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04665609","url":"https://clinicaltrials.gov/study/NCT04665609"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc"],"sections":[],"technologies":["thermal-ablation"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04665609","phase":"3","setting":"Safety and Effectiveness of Thermal Ablation Combined With Anlotinib and TQB2450 Solution for Advanced Hepatocelualr Carcinoma","sponsor":"Chinese PLA General Hospital","started":"2021-03-05","startedType":"estimated","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05208944","kind":"trial","name":"THIO Sequenced With Cemiplimab in Advanced NSCLC","aka":[],"tldr":"A phase 2 trial of Cemiplimab in non-small-cell lung cancer, run by Maia Biotechnology, active and no longer recruiting.","summary":"THIO Sequenced With Cemiplimab in Advanced NSCLC is a phase 2 interventional study registered as NCT05208944 by Maia Biotechnology, with 227 participants enrolled, started 2022-06-08 and due to reach its primary completion in 2027-09-30. Interventions recorded: 6-Thio-2'-Deoxyguanosine and Cemiplimab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05208944","url":"https://clinicaltrials.gov/study/NCT05208944"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":["maia-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05208944","phase":"2","setting":"A Multicenter, Open-Label, Dose-Finding, Phase 2 Study Evaluating THIO Sequenced With Cemiplimab (LIBTAYO®) in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Maia Biotechnology","started":"2022-06-08","startedType":"actual","enrolled":227,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06758401","kind":"trial","name":"This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lu","aka":[],"tldr":"A phase 3 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Pfizer, now recruiting.","summary":"This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1. is a phase 3 interventional study registered as NCT06758401 by Pfizer, with 714 participants planned, started 2025-07-23 and due to reach its primary completion in 2028-09-05. Interventions recorded: Sigvotatug Vedotin, Pembrolizumab. Conditions listed: Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Non-Small-Cell Lung (NSCLC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06758401","url":"https://clinicaltrials.gov/study/NCT06758401"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06758401","phase":"3","setting":"AN OPEN-LABEL, RANDOMIZED, CONTROLLED PHASE 3 STUDY OF SIGVOTATUG VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB COMPARED WITH PEMBROLIZUMAB MONOTHERAPY AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH PD-L1 HIGH (≥50% OF TUMOR CELLS EXPRESSING PD-L1), LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC NON-SMALL CELL LUNG CANCER (BE6A LUNG-02)","sponsor":"Pfizer","started":"2025-07-23","startedType":"actual","enrolled":714,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07649122","kind":"trial","name":"This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer.","aka":[],"tldr":"A phase 3 trial of an investigational treatment in prostate cancer, run by Norroy Bioscience Co., LTD, now recruiting.","summary":"This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer. is a phase 3 interventional study registered as NCT07649122 by Norroy Bioscience Co., LTD, with 232 participants planned, started 2026-08-31 and due to reach its primary completion in 2028-06-30.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07649122","url":"https://clinicaltrials.gov/study/NCT07649122"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["pet","pet-ct"],"targets":[],"drugs":[],"companies":["norroy-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07649122","phase":"3","setting":"A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Safety of 68Ga-NYM032 Injection PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer","sponsor":"Norroy Bioscience Co., LTD","started":"2026-08-31","startedType":"actual","enrolled":232,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07028853","kind":"trial","name":"This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking En","aka":["MEVPRO-3"],"tldr":"A phase 3 trial of Mevrometostat, Enzalutamide in prostate cancer, run by Pfizer, now recruiting.","summary":"This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve. is a phase 3 interventional study registered as NCT07028853 by Pfizer, with 1000 participants planned, started 2025-09-28 and due to reach its primary completion in 2028-09-12. Interventions recorded: Mevrometostat, Placebo, Enzalutamide. Conditions listed: Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07028853","url":"https://clinicaltrials.gov/study/NCT07028853"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation","epigenetic-drugs"],"targets":[],"drugs":["mevrometostat","enzalutamide"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07028853","phase":"3","setting":"A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)","sponsor":"Pfizer","started":"2025-09-28","startedType":"actual","enrolled":1000,"enrolledBasis":"registry","outcomes":[]},{"id":"thor","kind":"trial","name":"THOR","aka":[],"tldr":"The first targeted pill to lengthen survival in bladder cancer, for the fifth of tumours with FGFR alterations.","summary":"THOR, trial NCT03390504 sponsored by Johnson & Johnson and reported in 2023, produced the first targeted tablet to lengthen survival in bladder cancer, for the fifth of advanced urothelial tumours with FGFR alterations. Cohort 1 randomised 266 patients with FGFR3 or FGFR2 alterations after chemotherapy and a checkpoint inhibitor to erdafitinib or chemotherapy and met its primary overall survival endpoint with a clear benefit, while cohort 2, against pembrolizumab in immunotherapy-naive patients, showed no benefit, so erdafitinib is positioned after immunotherapy; full FDA approval followed in January 2024. OnCo links it to bladder cancer, FGFR2 as a target, erdafitinib and the FGFR3 alterations term, and THOR-2 explored intravesical and oral use in non-muscle-invasive disease. Whether FGFR inhibitors can be combined with immunotherapy rather than sequenced after it is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03390504","url":"https://clinicaltrials.gov/study/NCT03390504"}],"tags":[],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["fgfr2"],"drugs":["erdafitinib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["fgfr3"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03390504","phase":"3","setting":"Advanced urothelial cancer with FGFR3/2 alterations after chemotherapy and a checkpoint inhibitor: erdafitinib vs chemotherapy (cohort 1)","sponsor":"Johnson & Johnson","result":"OS 12.1 vs 7.8 months, HR 0.64 (cohort 1).","started":"2018-03-23","startedType":"actual","yearReported":2023,"enrolled":266,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (cohort 1)","primary":true,"unit":"months","arms":[{"name":"Erdafitinib","n":136,"value":12.1},{"name":"Chemotherapy","n":130,"value":7.8}],"hr":0.64,"ci":[0.47,0.88],"p":"0.005","source":"https://ascopubs.org/doi/10.1200/JCO.2023.41.17_suppl.LBA4619"}],"replication":"Cohort 2 (vs pembrolizumab) negative; benefit confined to the post-IO setting."},{"id":"nct06865339","kind":"trial","name":"Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer","aka":["TRIPL"],"tldr":"A phase 2 trial of cemiplimab and fianlimab in lung cancer, run by Montefiore Medical Center, now recruiting.","summary":"Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer is a phase 2, interventional study registered as NCT06865339 by Montefiore Medical Center, with a registry enrolment figure of 76 participants, started 2025-08-07 and due to reach its primary completion in 2027-08. Interventions recorded: Cemiplimab; Fianlimab; Radiotherapy; Platinum Doublet Chemotherapy (PDC). Conditions listed: NSCLC; Locally Advanced. Primary outcome: Objective Response Rate (ORR) to induction IO therapy. Lung eligibility wording from the registry: \"* Previously untreated and biopsy-proven NSCLC, with measurable disease (at least 1 unidimensional, radiographically measurable lesion based on RECIST v1\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06865339","url":"https://clinicaltrials.gov/study/NCT06865339"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["cemiplimab","fianlimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06865339","phase":"2","setting":"TRIPL: Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer","sponsor":"Montefiore Medical Center","started":"2025-08-07","startedType":"actual","enrolled":76,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05086614","kind":"trial","name":"Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by Fudan University, now recruiting.","summary":"Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer is a phase 3, randomised interventional study registered as NCT05086614 by Fudan University, with a registry enrolment figure of 2500 participants, started 2021-04-01 and due to reach its primary completion in 2027-03-31. Interventions recorded: Thymosin Alpha1. Conditions listed: Stage II Colorectal Cancer; Stage III Colorectal Cancer. Primary outcome: 3-year disease-free survival rate. Colorectal eligibility wording from the registry: \"* Colorectal cancer receiving radical resection\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05086614","url":"https://clinicaltrials.gov/study/NCT05086614"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05086614","phase":"3","setting":"The Efficacy and Safety of Thymosin-alpha 1 Used for Adjuvant Treatment After Radical Resection of High-risk Stage II and Stage III Colorectal Cancer","sponsor":"Fudan University","started":"2021-04-01","startedType":"actual","enrolled":2500,"enrolledBasis":"registry","outcomes":[]},{"id":"tiger-trial","kind":"trial","name":"TIGER: standard-dose TIP versus high-dose TI-CE with stem cell transplant as first salvage for relapsed germ cell tumours","aka":[],"tldr":"The trial meant to settle a thirty-year argument: whether men whose germ cell tumour comes back after cisplatin should get standard salvage chemotherapy or high-dose chemotherapy with a stem cell transplant.","summary":"Relapsed germ cell tumours are still curable, but retrospective comparisons have long suggested that high-dose chemotherapy with stem cell rescue beats conventional-dose salvage, without a randomised proof. TIGER, run by the Alliance with European cooperative groups, randomises patients at first relapse between four cycles of TIP and the TI-CE high-dose programme. It is active and no longer recruiting, with overall survival as the primary endpoint. Patients with primary mediastinal non-seminoma, the poorest-risk extragonadal group, are among those most in need of the answer.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02375204","url":"https://clinicaltrials.gov/study/NCT02375204"}],"tags":["owner-request"],"related":[],"cancers":["testicular","extragonadal-germ-cell-tumour","non-seminoma"],"sections":[],"technologies":["autologous-stem-cell-transplant"],"targets":[],"drugs":["paclitaxel","ifosfamide","cisplatin","carboplatin","etoposide"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02375204","phase":"3","setting":"First relapse of metastatic germ cell tumour after cisplatin-based chemotherapy, including extragonadal primaries: conventional-dose paclitaxel, ifosfamide and cisplatin (TIP) versus high-dose carboplatin and etoposide with autologous stem cell support after paclitaxel and ifosfamide (TI-CE); international, 420 planned, started 2015","sponsor":"Alliance for Clinical Trials in Oncology","started":"2015-08-06","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06532812","kind":"trial","name":"TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer","aka":["BAH249"],"tldr":"A phase 1/2 trial of fludarabine, aldesleukin (high-dose il-2) and pembrolizumab in triple-negative breast cancer, run by Essen Biotech, now recruiting.","summary":"TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer is a phase 1/2, interventional study registered as NCT06532812 by Essen Biotech, with a registry enrolment figure of 85 participants, started 2024-08-22 and due to reach its primary completion in 2025-12-10. Interventions recorded: Tumor Infiltrating Lymphocytes (TIL); Cyclophosphamid; Fludarabine; Interleukin-2; Pembrolizumab. Conditions listed: Breast Cancer; Breast Carcinoma; Breast Cancer Metastatic; Breast Cancer Triple Negative. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06532812","url":"https://clinicaltrials.gov/study/NCT06532812"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["fludarabine","aldesleukin","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06532812","phase":"1/2","setting":"Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Pembrolizumab (Keytruda) Immunotherapy in Patients With Advanced or Metastatic Refractory Breast Cancer","sponsor":"Essen Biotech","started":"2024-08-22","startedType":"actual","enrolled":85,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07074106","kind":"trial","name":"TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC","aka":["DespaTIL"],"tldr":"A phase 2 trial of carboplatin in triple-negative breast cancer, run by D'Or Institute for Research and Education, now recruiting.","summary":"TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC is a phase 2, interventional study registered as NCT07074106 by D'Or Institute for Research and Education, with a registry enrolment figure of 40 participants, started 2025-10-31 and due to reach its primary completion in 2027-07-01. Interventions recorded: Carboplatin and a Taxane. Conditions listed: Breast Cancer. Sites: Brazil. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07074106","url":"https://clinicaltrials.gov/study/NCT07074106"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07074106","phase":"2","setting":"DespaTIL Study: A Phase II Trial of De-escalated Neoadjuvant Chemotherapy for Early-Stage Triple-Negative Breast Cancer Guided by Tumor-Infiltrating Lymphocytes (TILs) and Radiologic Response","sponsor":"D'Or Institute for Research and Education","started":"2025-10-31","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"time2","kind":"trial","name":"TIME2","aka":["Second Therapeutic Intervention in Malignant Effusion Trial"],"tldr":"Compared a permanent drain you empty at home with the older operation that glues the lung to the chest wall, and found both relieve breathlessness equally, so the choice is about what a patient wants.","summary":"A malignant pleural effusion is one of the commonest causes of disabling breathlessness in lung cancer, and it recurs. TIME2 recruited 106 of 143 patients at seven United Kingdom hospitals between April 2007 and February 2011 and randomised them to an indwelling pleural catheter, inserted as an outpatient with a large initial drainage, education and subsequent home drainage, or to admission for chest tube insertion and talc slurry pleurodesis. Patients scored their breathlessness daily on a 100 mm visual analogue scale for 42 days; 10 mm is the minimum clinically important difference.\n\nBreathlessness improved in both groups and there was no significant difference over the first 42 days: mean score 24.7 mm (95 percent confidence interval 19.3 to 30.1) with the catheter against 24.4 mm (19.4 to 29.4) with talc, a difference of 0.16 mm (-6.82 to 7.15, p=0.96). The catheter group spent fewer days in hospital; the talc group needed fewer further pleural procedures.\n\nTIME2 is why an indwelling pleural catheter is offered as a first-line option rather than a salvage one, and why the decision is framed around hospital time and trapped lung rather than around symptom control, which the two methods deliver equally.","status":"mixed","asOf":"2026-09-25","links":[{"label":"TIME2 (JAMA 2012)","url":"https://doi.org/10.1001/jama.2012.5535"},{"label":"ISRCTN87514420","url":"https://www.isrctn.com/ISRCTN87514420"}],"tags":[],"related":[],"cancers":["nsclc","sclc","lung-cancer","pleural-mesothelioma"],"sections":[],"technologies":["palliative-care"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["palliative-treatment","pleural-effusion"],"trials":["ample"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN87514420","phase":"3","setting":"Malignant pleural effusion without previous pleurodesis: an indwelling pleural catheter inserted as an outpatient with home drainage, versus admission for chest tube and talc slurry pleurodesis, with daily 100 mm visual analogue breathlessness scores over 42 days as the primary outcome","sponsor":"Oxford Radcliffe Hospitals and the UK pleural research collaboration","result":"No significant difference in breathlessness over 42 days (24.7 against 24.4 mm on a 100 mm scale, difference 0.16 mm, p=0.96); fewer hospital days with the catheter.","yearReported":2012,"enrolled":106,"enrolledBasis":"randomised","enrolledNote":"106 of 143 patients treated at seven UK hospitals were randomised; the ISRCTN87514420 record gives a target of 106.","outcomes":[{"endpoint":"Mean breathlessness, 0-42 days (100 mm visual analogue scale)","primary":true,"arms":[{"name":"Indwelling pleural catheter","value":24.7},{"name":"Chest tube and talc pleurodesis","value":24.4}],"p":"0.96","source":"https://doi.org/10.1001/jama.2012.5535"}],"replication":"AMPLE reproduced the equivalence for symptom control and showed the catheter reduces total hospital days."},{"id":"tinivo-2","kind":"trial","name":"TiNivo-2","aka":[],"tldr":"A second trial confirming that restarting immunotherapy after it fails does not help kidney cancer patients.","summary":"TiNivo-2, trial NCT04987203 sponsored by AVEO, now part of LG Chem, and reported in 2024 with a final analysis in 2026, was the second trial confirming that restarting immunotherapy after it fails does not help kidney cancer patients. It randomised 343 patients with advanced renal cell carcinoma after progression on a PD-1 or PD-L1 inhibitor to tivozanib plus nivolumab or tivozanib alone and found no progression-free survival benefit from adding nivolumab. OnCo links it to renal cell carcinoma, tivozanib, nivolumab and the caution pairing about PD-1 rechallenge after progression, and the result is consistent with CONTACT-03. Together the two trials settle the rechallenge question in kidney cancer for now, while tivozanib monotherapy remains an option after prior therapy on the basis of TIVO-3.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04987203","url":"https://clinicaltrials.gov/study/NCT04987203"}],"tags":["lesson:io-rechallenge"],"related":[],"cancers":["rcc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["tivozanib","nivolumab"],"companies":["aveo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04987203","phase":"3","setting":"Advanced RCC after progression on a PD-1/PD-L1 inhibitor: tivozanib + nivolumab vs tivozanib","sponsor":"AVEO (LG Chem)","result":"PFS HR 1.10; no benefit from nivolumab rechallenge.","started":"2021-09-09","startedType":"actual","yearReported":2024,"enrolled":343,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Tivozanib + nivolumab","n":171,"value":5.7},{"name":"Tivozanib","n":172,"value":7.4}],"hr":1.1,"ci":[0.84,1.43],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01758-6/fulltext"}],"replication":"Consistent with CONTACT-03."},{"id":"nct03736889","kind":"trial","name":"Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors","aka":[],"tldr":"A phase 2 trial of Tislelizumab in advanced solid tumours, run by BeiGene, now recruiting.","summary":"Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors is a phase 2 interventional study registered as NCT03736889 by BeiGene, with 200 participants planned, started 2018-09-19 and due to reach its primary completion in 2026-11. Interventions recorded: Tislelizumab (BGB-A317).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03736889","url":"https://clinicaltrials.gov/study/NCT03736889"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03736889","phase":"2","setting":"A Single-Arm, Multi-Center, Open-Label, Phase 2 Study to Evaluate Efficacy and Safety of Tislelizumab (BGB-A317), an Anti-PD-1 Monoclonal Antibody, as Monotherapy in Patients With Previously-Treated Locally Advanced Unresectable or Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors","sponsor":"BeiGene","started":"2018-09-19","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05841134","kind":"trial","name":"Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of tislelizumab in colorectal cancer, run by The First Affiliated Hospital of Zhengzhou University, not yet recruiting.","summary":"Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer is a phase 2, interventional study registered as NCT05841134 by The First Affiliated Hospital of Zhengzhou University, with a registry enrolment figure of 25 participants, started 2023-06-01 and due to reach its primary completion in 2024-12-31. Interventions recorded: Tislelizumab. Conditions listed: MSI-H Colorectal Cancer; Tislelizumab; Oxaliplatin; Capecitabine. Primary outcome: Percentage of Participants With Pathological Complete Response (pCR). Colorectal eligibility wording from the registry: \"Patients with colon or rectal adenocarcinoma confirmed by histology or cytology;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05841134","url":"https://clinicaltrials.gov/study/NCT05841134"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05841134","phase":"2","setting":"Multicenter, Single-arm, Open-label Phase II Clinical Study of Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer","sponsor":"The First Affiliated Hospital of Zhengzhou University","started":"2023-06-01","startedType":"estimated","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06538896","kind":"trial","name":"Tislelizumab Combined with Nab-Paclitaxel for First-Line Treatment of Advanced Triple-Negative Breast Cancer with Bone Metastasis，an Exploratory, Single-Arm, Mu","aka":[],"tldr":"A phase 2 trial of tislelizumab and nab-paclitaxel in triple-negative breast cancer, run by Zhejiang Cancer Hospital, now recruiting.","summary":"Tislelizumab Combined with Nab-Paclitaxel for First-Line Treatment of Advanced Triple-Negative Breast Cancer with Bone Metastasis，an Exploratory, Single-Arm, Multicenter Phase II Clinical Study is a phase 2, interventional study registered as NCT06538896 by Zhejiang Cancer Hospital, with a registry enrolment figure of 20 participants, started 2024-08-20 and due to reach its primary completion in 2026-12. Interventions recorded: Tislelizumab + Nab-Paclitaxel; Rankl inhibitor. Conditions listed: Triple-negative Breast Cancer; Bone Metastases. Triple-negative eligibility wording from the registry: \"Metastatic triple-negative breast cancer (TNBC) confirmed by histological examination, i\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06538896","url":"https://clinicaltrials.gov/study/NCT06538896"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["tislelizumab","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06538896","phase":"2","setting":"Exploratory Single-Arm, Multicenter Phase II Study of Tislelizumab Combined with Nab-Paclitaxel As First Line Treatment for Patients of Triple-negative Breast Cancer(TNBC) with Bone Metastasis","sponsor":"Zhejiang Cancer Hospital","started":"2024-08-20","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06332274","kind":"trial","name":"tislelizUMaB in canceR Patients With molEcuLar residuaL Disease","aka":["UMBRELLA"],"tldr":"A phase 3 trial of tislelizumab in pancreatic cancer, run by Gustave Roussy, Cancer Campus, Grand Paris, now recruiting.","summary":"tislelizUMaB in canceR Patients With molEcuLar residuaL Disease is a phase 3, randomised interventional study registered as NCT06332274 by Gustave Roussy, Cancer Campus, Grand Paris, with a registry enrolment figure of 717 participants, started 2025-04-16 and due to reach its primary completion in 2029-04. Interventions recorded: Tislelizumab; Blood sampling; Placebo. Conditions listed: Cancer; Lung Cancer; Colo-rectal Cancer; Pancreas Cancer; Soft Tissue Sarcoma. Primary outcome: Efficacy of tislelizumab compared to placebo as measured by DFS (Disease-free survival). Pancreatic eligibility wording from the registry: \"Histology: TNM stage II-III NSCLC, Stage II-III colorectal cancer, stage I-III pancreatic cancer, grade 3 limb or trunk wall soft-tissue sarcoma\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06332274","url":"https://clinicaltrials.gov/study/NCT06332274"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06332274","phase":"3","setting":"tislelizUMaB in canceR Patients With molEcuLar residuaL Disease","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","started":"2025-04-16","startedType":"actual","enrolled":717,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07681297","kind":"trial","name":"Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Dis","aka":["TIBEC"],"tldr":"A phase 1/2 trial of tislelizumab, bevacizumab and capecitabine in triple-negative breast cancer, run by National University Hospital, Singapore, not yet recruiting.","summary":"Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Disease is a phase 1/2, interventional study registered as NCT07681297 by National University Hospital, Singapore, with a registry enrolment figure of 154 participants, started 2026-08 and due to reach its primary completion in 2028-08. Interventions recorded: Tislelizumab + Bevacizumab + Capecitabine. Conditions listed: Advanced Solid Tumor Cancer; Triple-Negative Breast Cancer (TNBC); CNS Disease; Breast Cancer. Triple-negative eligibility wording from the registry: \"TNBC Cohort Inclusion Criteria\". Sites: Singapore. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07681297","url":"https://clinicaltrials.gov/study/NCT07681297"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["tislelizumab","bevacizumab","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07681297","phase":"1/2","setting":"Phase Ib/II Study of Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Disease (TIBEC)","sponsor":"National University Hospital, Singapore","started":"2026-08","startedType":"estimated","enrolled":154,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06529523","kind":"trial","name":"Tislelizumab in People With Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of tislelizumab in colorectal cancer, run by Memorial Sloan Kettering Cancer Center, now recruiting.","summary":"Tislelizumab in People With Colorectal Cancer is a phase 2, interventional study registered as NCT06529523 by Memorial Sloan Kettering Cancer Center, with a registry enrolment figure of 40 participants, started 2024-07-26 and due to reach its primary completion in 2028-07. Interventions recorded: Tislelizumab. Conditions listed: Colorectal Cancer. Primary outcome: objective response rate of PD-1 blockade with tislelizumab. Colorectal eligibility wording from the registry: \"* Surgically sterile (ie, through bilateral salpingectomy, bilateral oophorectomy, or hysterectomy)\". Sites: Nigeria, United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06529523","url":"https://clinicaltrials.gov/study/NCT06529523"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06529523","phase":"2","setting":"PD-1 (Programmed Cell Death Protein 1) Blockade in Mismatch-repair Deficient Colorectal Cancer in Nigeria","sponsor":"Memorial Sloan Kettering Cancer Center","started":"2024-07-26","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07155525","kind":"trial","name":"Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas","aka":["NBCA-MS"],"tldr":"A phase 3 trial in pancreatic cancer, run by Minia University, now recruiting.","summary":"Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas is a phase 3, randomised interventional study registered as NCT07155525 by Minia University, with a registry enrolment figure of 194 participants, started 2025-09-15 and due to reach its primary completion in 2028-09-15. Interventions recorded: Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2); Standard(duct-to-mucosa) Pancreaticojejunostomy. Conditions listed: Pancreatic Cancer; Periampullary Cancer; Duodenal Cancer; Cholangiocarcinoma; Pancreatic Ductal Adenocarcinoma; Pancreatic Head Mass; Bile Duct Cancer. Primary outcome: Incidence of Postoperative Pancreatic Fistula (POPF).. Pancreatic eligibility wording from the registry: \"* Patients scheduled for elective pancreaticoduodenectomy for malignant lesions\". Sites: Egypt. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07155525","url":"https://clinicaltrials.gov/study/NCT07155525"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["resectable-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07155525","phase":"3","setting":"Pancreaticojejunostomy With or Without Modified N-butyl-2-cyanoacrylate Following Pancreaticoduodenectomy in Soft Pancreas: Randomized Controlled Trial","sponsor":"Minia University","started":"2025-09-15","startedType":"actual","enrolled":194,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06589830","kind":"trial","name":"TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of Trastuzumab in colorectal cancer, run by Suzhou Teligene Ltd., now recruiting.","summary":"TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer is a phase 2 interventional study registered as NCT06589830 by Suzhou Teligene Ltd., with 80 participants planned, started 2025-05-13 and due to reach its primary completion in 2026-10. Interventions recorded: TL938 Capsules, Trastuzumab. Conditions listed: Colorectal Cancer Metastatic, Advanced Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06589830","url":"https://clinicaltrials.gov/study/NCT06589830"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","her2-amplified-colorectal"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["trastuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06589830","phase":"2","setting":"A Phase 2 Study to Evaluate TL938 Combined With Trastuzumab in Patients With HER2-positive Metastatic Colorectal Cancer","sponsor":"Suzhou Teligene Ltd.","started":"2025-05-13","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"tmist","kind":"trial","name":"TMIST (Tomosynthesis Mammographic Imaging Screening Trial)","aka":[],"tldr":"The trial that will settle whether 3D mammograms prevent more dangerous cancers than standard 2D ones, or just find more small ones.","summary":"TMIST (ECOG-ACRIN EA1151) is the only randomised trial comparing tomosynthesis with digital mammography on a clinically meaningful endpoint, the rate of advanced cancers (larger, node-positive, metastatic or aggressive subtypes) over 4.5 years, rather than detection rate. Enrolment of about 108,000 women across North America, Argentina and other countries closed in 2024 after a slow start and a downsized target; the trial also builds a biorepository for risk-based screening research. Observational studies show tomosynthesis finds more cancers with fewer recalls, especially in dense breasts, but whether that translates into fewer advanced cancers is exactly what is unknown.","status":"active","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03233191","url":"https://clinicaltrials.gov/study/NCT03233191"},{"label":"ECOG-ACRIN: TMIST","url":"https://ecog-acrin.org/clinical-trials/tmist-breast-cancer-screening-trial/"}],"tags":[],"related":[],"cancers":["breast-hr-positive","tnbc","breast-her2-positive"],"sections":[],"technologies":["mammography"],"targets":[],"drugs":[],"companies":["ecog-acrin"],"institutions":[],"pathways":[],"terms":["screening","overdiagnosis"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03233191","phase":"3","setting":"Women aged 45 to 74 randomised to screening with digital breast tomosynthesis (3D) or standard digital mammography, primary endpoint advanced breast cancer","sponsor":"ECOG-ACRIN / NCI","started":"2017-09-28","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"tnt","kind":"trial","name":"TNT (Triple Negative Trial)","aka":["TNT trial","NCT00532727"],"tldr":"The UK phase 3 trial that showed carboplatin is not better than docetaxel for triple-negative breast cancer as a whole, but is for the germline BRCA1/2 subgroup, and that gave the NHS its evidence for platinum in BRCA carriers.","summary":"TNT randomised women with metastatic or recurrent locally advanced triple-negative or BRCA1/2-associated breast cancer to carboplatin or docetaxel, crossing over at progression. Reported in Nature Medicine in 2018 with Andrew Tutt as first author, it found no advantage for carboplatin in the unselected triple-negative population but a doubling of response for germline BRCA1/2 carriers, and no benefit from BRCAness signatures in predicting platinum response. It was run by the Cancer Research UK funded Clinical Trials and Statistics Unit at the ICR.","status":"mixed","asOf":"2026-09-24","links":[{"label":"Nature Medicine 2018 (DOI)","url":"https://doi.org/10.1038/s41591-018-0009-7"},{"label":"Be Part of Research record","url":"https://bepartofresearch.nihr.ac.uk/trial-details/trial-detail?trialId=NCT00532727"},{"label":"Tutt et al., Nature Medicine 2018: carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups, the TNT trial","url":"https://doi.org/10.1038/s41591-018-0009-7"}],"tags":["uk","breast","platinum"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["platinum","cytotoxic-chemotherapy"],"targets":["brca"],"drugs":["carboplatin","docetaxel"],"companies":[],"institutions":["icr-london","royal-marsden","breast-cancer-now"],"pathways":[],"terms":["gbrca-mutation","hrd"],"trials":["brocade3","olympiad"],"people":["andrew-tutt","jean-abraham"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Treatment reading (Nature Medicine 2018): 376 patients with unselected advanced triple-negative breast cancer randomised 1 to 1 to carboplatin or docetaxel; objective response 31.4 versus 34.0 percent (p 0.66) overall, but 68 versus 33 percent in germline BRCA carriers (interaction p 0.01), with no such interaction for BRCA1 methylation, low BRCA1 mRNA or a high Myriad HRD score. It is the trial behind the practice of offering a platinum first to germline BRCA carriers with metastatic triple-negative disease, and behind the conclusion that HRD assays do not select for platinum in this setting."],"nct":"NCT00532727","phase":"3","setting":"Metastatic or recurrent locally advanced triple-negative or BRCA1/2 breast cancer: carboplatin versus docetaxel, with crossover at progression","sponsor":"The Institute of Cancer Research (ICR-CTSU), funded by Cancer Research UK and Breast Cancer Now","result":"No superiority of carboplatin over docetaxel in unselected triple-negative disease; higher response to carboplatin in the germline BRCA1/2 subgroup (Nature Medicine 2018).","started":"2008-01","startedType":"actual","yearReported":2018,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05646511","kind":"trial","name":"TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer","aka":["ENSEMBLE"],"tldr":"A phase 3 trial of cAPOX (capecitabine, oxaliplatin) in colorectal cancer, run by National Cancer Center Hospital East, now recruiting.","summary":"TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT05646511 by National Cancer Center Hospital East, with a registry enrolment figure of 608 participants, started 2022-11-21 and due to reach its primary completion in 2029-12-31. Interventions recorded: SCRT; CAPOX; CAPOXIRI. Conditions listed: Locally Advanced Rectal Cancer. Primary outcome: Organ-preservation adapted DFS. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma\". Sites: Japan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05646511","url":"https://clinicaltrials.gov/study/NCT05646511"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05646511","phase":"3","setting":"A Multicenter Randomized Phase III Study of Short-term Radiotherapy Plus CAPOX and Short-term Radiotherapy Plus CAPOXIRI as Preoperative Treatment for Locally Advanced Rectal Cancer","sponsor":"National Cancer Center Hospital East","started":"2022-11-21","startedType":"actual","enrolled":608,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03330847","kind":"trial","name":"To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.","aka":["VIOLETTE"],"tldr":"A phase 2 trial of Olaparib and Ceralasertib in triple-negative breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy. is a phase 2 interventional study registered as NCT03330847 by AstraZeneca, with 273 participants enrolled, started 2018-03-07 and due to reach its primary completion in 2020-11-13. Interventions recorded: Olaparib Continuous (28-Day cycle) 300 mg BD., Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle). and Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03330847","url":"https://clinicaltrials.gov/study/NCT03330847"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["olaparib","ceralasertib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03330847-clin-cancer-res-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03330847","phase":"2","setting":"A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination With Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-Related Genes (Including BRCA1/2) (VIOLETTE).","sponsor":"AstraZeneca","started":"2018-03-07","startedType":"actual","yearReported":2022,"enrolled":273,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (Per BICR), All patients per BICR","unit":"months","arms":[{"name":"Olaparib Monotherapy","n":114,"value":3.6,"note":"90% CI 2.9 to 5.4; Figures from the ClinicalTrials.gov results section (first posted 2022-03-22), not from a publication"},{"name":"Olaparib + Ceralasertib","n":112,"value":5.3,"note":"90% CI 3.7 to 5.5"},{"name":"Olaparib + Adavosertib","n":47,"value":3.8,"note":"90% CI 3.7 to 5.6"}],"source":"https://clinicaltrials.gov/study/NCT03330847?tab=results"},{"endpoint":"Number of Patients With Objective Response (Per BICR and Per Sensitivity Analysis), All patients per BICR","unit":"participants","arms":[{"name":"Olaparib Monotherapy","n":114,"value":24,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-03-22), not from a publication"},{"name":"Olaparib + Ceralasertib","n":112,"value":32},{"name":"Olaparib + Adavosertib","n":47,"value":9}],"source":"https://clinicaltrials.gov/study/NCT03330847?tab=results"}]},{"id":"nct04853342","kind":"trial","name":"To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy","aka":["FORWARD"],"tldr":"A phase 3 trial of Furmonertinib in non-small-cell lung cancer, run by Allist Pharmaceuticals, Inc., now recruiting.","summary":"To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy is a phase 3 interventional study registered as NCT04853342 by Allist Pharmaceuticals, Inc., with 318 participants planned, started 2021-06-07 and due to reach its primary completion in 2026-12. Interventions recorded: Drug: Furmonertinib 80 mg and Furmonertinib 80 mg placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04853342","url":"https://clinicaltrials.gov/study/NCT04853342"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["furmonertinib"],"companies":["allist"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04853342","phase":"3","setting":"A Phase III, Double-blind, Randomized, Placebo-Controlled Multi-centre, Study to Assess the Efficacy and Safety of Furmonertinib (AST2818) Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy","sponsor":"Allist Pharmaceuticals, Inc.","started":"2021-06-07","startedType":"actual","enrolled":318,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06344052","kind":"trial","name":"To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma","aka":[],"tldr":"A phase 2 trial of Vismodegib in basal cell carcinoma, run by Stamford Pharmaceuticals, Inc., now recruiting.","summary":"To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma is a phase 2 interventional study registered as NCT06344052 by Stamford Pharmaceuticals, Inc., with 80 participants planned, started 2024-04-09 and due to reach its primary completion in 2026-09-30. Interventions recorded: SP-002, Vismodegib. Conditions listed: Basal Cell Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06344052","url":"https://clinicaltrials.gov/study/NCT06344052"}],"tags":["ctgov-ingest"],"related":[],"cancers":["basal-cell-carcinoma","locally-advanced-bcc"],"sections":[],"technologies":["hedgehog-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["vismodegib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06344052","phase":"2","setting":"A Phase 2 Study to Assess the Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma","sponsor":"Stamford Pharmaceuticals, Inc.","started":"2024-04-09","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04661007","kind":"trial","name":"To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL","aka":["J-MIND"],"tldr":"A phase 1/2 trial of Tafasitamab, Lenalidomide in diffuse large b-cell lymphoma, run by Incyte Biosciences Japan GK, active and no longer recruiting.","summary":"To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL) is a phase 1/2 interventional study registered as NCT04661007 by Incyte Biosciences Japan GK, with 72 participants enrolled, started 2020-12-15 and due to reach its primary completion in 2025-07-01. Interventions recorded: tafasitamab, lenalidomide, parsaclisib, R-CHOP. Conditions listed: Non Hodgkins Lymphoma, Diffuse Large B-cell Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04661007","url":"https://clinicaltrials.gov/study/NCT04661007"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["monoclonal-antibody","protac-degrader"],"targets":[],"drugs":["tafasitamab","lenalidomide"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04661007","phase":"1/2","setting":"A Phase 1b/2 Study of Tafasitamab, Tafasitamab Plus Lenalidomide, Tafasitamab Plus Parsaclisib, and Tafasitamab Plus Lenalidomide in Combination With R-CHOP in Japanese Participants With Non-Hodgkin Lymphoma","sponsor":"Incyte Biosciences Japan GK","started":"2020-12-15","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06693375","kind":"trial","name":"To Evaluate Dose and Safety of NanoEcho Particle-1 Using NanoEcho Imaging Device Examinations of Rectal Lymph Nodes in Healthy Volunteers and Rectal Cancer Patients.","aka":[],"tldr":"A phase 2 trial of Iron oxide nanoparticles in colorectal cancer, run by NanoEcho AB, now recruiting.","summary":"To Evaluate Dose and Safety of NanoEcho Particle-1 Using NanoEcho Imaging Device Examinations of Rectal Lymph Nodes in Healthy Volunteers and Rectal Cancer Patients. is a phase 2 interventional study registered as NCT06693375 by NanoEcho AB, with 12 participants planned, started 2024-10-29 and due to reach its primary completion in 2026-05. Interventions recorded: Iron oxide nanoparticles and Rectal Magnetomotoric ultrasound (MMUS).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06693375","url":"https://clinicaltrials.gov/study/NCT06693375"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["ultrasound"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06693375","phase":"2","setting":"A Phase 2a, Exploratory, Two-Part, Open-Label Trial to Evaluate Dose and Safety of NanoEcho Particle-1 (Ferumoxtran) Using NanoEcho Imaging Device Examinations of Rectal Lymph Nodes in Healthy Volunteers, Part A, and Rectal Cancer Patients, Part B.","sponsor":"NanoEcho AB","started":"2024-10-29","startedType":"actual","enrolled":12,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04301739","kind":"trial","name":"to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versu","aka":[],"tldr":"A phase 3 trial of serplulimab, nab-paclitaxel, carboplatin, doxorubicin and other drugs in triple-negative breast cancer, run by Shanghai Henlius Biotech, not yet recruiting.","summary":"to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC) is a phase 3, randomised interventional study registered as NCT04301739 by Shanghai Henlius Biotech, with a registry enrolment figure of 522 participants, started 2020-04-17 and due to reach its primary completion in 2022-09-07. Interventions recorded: HLX10; nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide; Placebo. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Subjects histologically diagnosed with previously untreated TNBC (lack of human epidermal growth factor receptor-2 \\[HER2\\], estrogen receptor \\[ER\\], progesterone receptor expression as determined by the study site)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04301739","url":"https://clinicaltrials.gov/study/NCT04301739"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["serplulimab","nab-paclitaxel","carboplatin","doxorubicin","epirubicin","cyclophosphamide"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04301739","phase":"3","setting":"A Randomized, Double-Blind, International Multi-Centre, Phase III Clinical Study to Evaluate Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC)","sponsor":"Shanghai Henlius Biotech","started":"2020-04-17","startedType":"estimated","enrolled":522,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05468489","kind":"trial","name":"To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC","aka":["ASTRIDE"],"tldr":"A phase 3 trial of Serplulimab, Atezolizumab in small-cell lung cancer, run by Shanghai Henlius Biotech, active and no longer recruiting.","summary":"To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC is a phase 3 interventional study registered as NCT05468489 by Shanghai Henlius Biotech, with 200 participants planned, started 2022-11-18 and due to reach its primary completion in 2026-02-28. Interventions recorded: Serplulimab + chemotherapy (carboplatin-etoposide), Atezolizumab + chemotherapy (carboplatin-etoposide). Conditions listed: Extensive Stage Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05468489","url":"https://clinicaltrials.gov/study/NCT05468489"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["serplulimab","atezolizumab"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05468489","phase":"3","setting":"A Randomized, Open-label Study of Serplulimab Plus Chemotherapy (Carboplatin-Etoposide) in Comparison With Atezolizumab Plus Chemotherapy in Previously Untreated US Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) (ASTRIDE)","sponsor":"Shanghai Henlius Biotech","started":"2022-11-18","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06072131","kind":"trial","name":"To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL","aka":["CRESCENDO"],"tldr":"A phase 3 trial of Belinostat and Pralatrexate in peripheral T-cell lymphomas, run by Acrotech Biopharma Inc., now recruiting.","summary":"To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL is a phase 3 interventional study registered as NCT06072131 by Acrotech Biopharma Inc., with 504 participants planned, started 2023-10-04 and due to reach its primary completion in 2030-07. Interventions recorded: Belinostat Injection, Pralatrexate Injection, CHOP and COP.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06072131","url":"https://clinicaltrials.gov/study/NCT06072131"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["belinostat","pralatrexate"],"companies":["acrotech-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06072131","phase":"3","setting":"A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients With Peripheral T-Cell Lymphoma","sponsor":"Acrotech Biopharma Inc.","started":"2023-10-04","startedType":"actual","enrolled":504,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06504732","kind":"trial","name":"To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer","aka":[],"tldr":"A phase 2/3 trial testing IAH0968 in gastric & gastro-oesophageal junction cancer, now recruiting.","summary":"To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer is a phase 2/3 interventional study registered as NCT06504732, led by SUNHO（China）BioPharmaceutical CO., and recruiting on the registry. Official title: A Phase II/III Clinical Study Evaluating IAH0968 in Combination or Not in Combination With the CAPEOX Regimen in HER2-expressing Advanced/Metastatic Solid Tumours and Gastric Cancer. Planned enrolment is 574 participants (estimated). The study started in 2024-08-15 and primary completion is expected in 2028-07. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06504732","url":"https://clinicaltrials.gov/study/NCT06504732"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["iah0968"],"companies":["hutchmed","sunho-biopharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06504732","phase":"2/3","setting":"A Phase II/III Clinical Study Evaluating IAH0968 in Combination or Not in Combination With the CAPEOX Regimen in HER2-expressing Advanced/Metastatic Solid Tumors and Gastric Cancer","sponsor":"SUNHO（China）BioPharmaceutical CO.","started":"2024-08-15","startedType":"actual","enrolled":574,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05442060","kind":"trial","name":"To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic N","aka":[],"tldr":"A phase 2 trial of Erlotinib in non-small-cell lung cancer and small-cell lung cancer, run by OBI Pharma, Inc, now recruiting.","summary":"To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer is a phase 2 interventional study registered as NCT05442060 by OBI Pharma, Inc, with 60 participants planned, started 2022-07-27 and due to reach its primary completion in 2025-12-31. Interventions recorded: 30 μg OBI-833/100 μg OBI-821, Erlotinib (150 mg daily). Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05442060","url":"https://clinicaltrials.gov/study/NCT05442060"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["erlotinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05442060","phase":"2","setting":"A Randomized, Open-Label, Phase 2 Study to Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"OBI Pharma, Inc","started":"2022-07-27","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06478719","kind":"trial","name":"To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization","aka":["FECHT"],"tldr":"A phase 1/2 trial of Placebo in hepatocellular carcinoma, run by Febico Biomedical Corp., now recruiting.","summary":"To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization is a phase 1/2 interventional study registered as NCT06478719 by Febico Biomedical Corp., with 120 participants planned, started 2024-06-24 and due to reach its primary completion in 2028-06-07. Interventions recorded: Placebo and FB-1603.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06478719","url":"https://clinicaltrials.gov/study/NCT06478719"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-intermediate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06478719","phase":"1/2","setting":"A Phase I/II Randomized, Double-blinded Study of FB-1603 to Evaluate the Safety and Efficacy in Hepatocellular Carcinoma Patients Receiving Transarterial Chemoembolization (FECHT Trial)","sponsor":"Febico Biomedical Corp.","started":"2024-06-24","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07795034","kind":"trial","name":"To Evaluate the Efficacy and Safety of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) Combined With NBB-001 and NBB-002 for Patients With Recurrent Head and Neck Malignancies","aka":[],"tldr":"A phase 2 trial of Boron Neutron Capture Therapy in head and neck squamous cell carcinoma, run by Neuboron Bio-SciTech Co., Ltd., now recruiting.","summary":"To Evaluate the Efficacy and Safety of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) Combined With NBB-001 and NBB-002 for Patients With Recurrent Head and Neck Malignancies is a phase 2 interventional study registered as NCT07795034 by Neuboron Bio-SciTech Co., Ltd., with 35 participants planned, started 2026-08-31 and due to reach its primary completion in 2027-08. Interventions recorded: Boron Neutron Capture Therapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07795034","url":"https://clinicaltrials.gov/study/NCT07795034"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["bnct"],"targets":[],"drugs":[],"companies":["neuboron-medtech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07795034","phase":"2","setting":"A Single-Arm, Open-Label Phase II Clinical Trial to Evaluate the Efficacy and Safety of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) Combined With NBB-001 and NBB-002 for Patients With Recurrent Head and Neck Malignancies","sponsor":"Neuboron Bio-SciTech Co., Ltd.","started":"2026-08-31","startedType":"estimated","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06389006","kind":"trial","name":"To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer","aka":[],"tldr":"A phase 2 trial of Disitamab vedotin, Toripalimab, Epirubicin and Cyclophosphamide in HER2-positive breast cancer and HR-positive / HER2-negative breast cancer, run by RemeGen Co., Ltd., now recruiting.","summary":"To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer is a phase 2 interventional study registered as NCT06389006 by RemeGen Co., Ltd., with 79 participants planned, started 2024-04-29 and due to reach its primary completion in 2025-06-01. Interventions recorded: Disitamab Vedotin for Injection, Toripalimab, Epirubicin and Cyclophosphamide.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06389006","url":"https://clinicaltrials.gov/study/NCT06389006"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["disitamab-vedotin","toripalimab","epirubicin","cyclophosphamide"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06389006","phase":"2","setting":"A Single-arm, Open-label, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer","sponsor":"RemeGen Co., Ltd.","started":"2024-04-29","startedType":"actual","enrolled":79,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05365178","kind":"trial","name":"To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer","aka":[],"tldr":"A phase 3 trial testing TQB3616 in HR-positive / HER2-negative breast cancer, active and no longer recruiting.","summary":"To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer is a phase 3 interventional study registered as NCT05365178, led by Chia Tai Tianqing Pharmaceutical, and active but no longer recruiting on the registry. Official title: A Randomised, Double-blind, Parallel-controlled Phase III Trial Evaluating the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated HR-positive, HER2-negative Advanced Breast Cancer. Planned enrolment is 432 participants (actual). The study started in 2022-07-01 and primary completion is expected in 2025-07-02. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05365178","url":"https://clinicaltrials.gov/study/NCT05365178"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb3616"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05365178","phase":"3","setting":"A Randomized, Double-blind, Parallel-controlled Phase III Trial Evaluating the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated HR-positive, HER2-negative Advanced Breast Cancer","sponsor":"Chia Tai Tianqing Pharmaceutical","started":"2022-07-01","startedType":"actual","enrolled":432,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05541822","kind":"trial","name":"To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation","aka":[],"tldr":"A phase 2 trial of Lazertinib in advanced solid tumours, run by Abion Inc, now recruiting.","summary":"To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation is a phase 2 interventional study registered as NCT05541822 by Abion Inc, with 178 participants planned, started 2023-01-17 and due to reach its primary completion in 2029-02. Interventions recorded: Vabametkib and Lazertinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05541822","url":"https://clinicaltrials.gov/study/NCT05541822"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["lazertinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05541822","phase":"2","setting":"A Phase 2 Multicenter, Open-Label, Parallel Cohort Expansion Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-Mesenchymal-epithelial Transition Factor (c-MET) Dysregulation","sponsor":"Abion Inc","started":"2023-01-17","startedType":"actual","enrolled":178,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06194448","kind":"trial","name":"To Evaluate the Efficacy/Safety of Osimertinib Prior to CRT and Maintenance of it With Stage III, Unresectable NSCLC With EGFR Mutations","aka":["NEOLA"],"tldr":"A phase 2 trial of Osimertinib, Carboplatin, Cisplatin and Pemetrexed in advanced solid tumours, run by AstraZeneca, active and no longer recruiting.","summary":"To Evaluate the Efficacy/Safety of Osimertinib Prior to CRT and Maintenance of it With Stage III, Unresectable NSCLC With EGFR Mutations is a phase 2 interventional study registered as NCT06194448 by AstraZeneca, with 76 participants enrolled, started 2024-04-21 and due to reach its primary completion in 2026-07-07. Interventions recorded: Osimertinib, Cisplatin or Carboplatin; Pemetrexed or Paclitaxel and Radiation.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06194448","url":"https://clinicaltrials.gov/study/NCT06194448"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib","carboplatin","cisplatin","pemetrexed"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06194448","phase":"2","setting":"A Phase II, Open-label, Single-arm Study of Osimertinib as Induction Therapy Prior to CRT and Maintenance Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Stage III, Unresectable Non-small Cell Lung Cancer (NEOLA)","sponsor":"AstraZeneca","started":"2024-04-21","startedType":"actual","enrolled":76,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06756269","kind":"trial","name":"To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years","aka":[],"tldr":"A phase 2 trial of Medium dose for 15-HPV vaccine in advanced solid tumours, run by Shanghai Bovax Biotechnology Co., Ltd., now recruiting.","summary":"To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years is a phase 2 interventional study registered as NCT06756269 by Shanghai Bovax Biotechnology Co., Ltd., with 330 participants planned, started 2025-01-15 and due to reach its primary completion in 2025-10-30. Interventions recorded: Medium dose for 15-HPV vaccine, High dose for 15-HPV vaccine, Placebo and 9-HPV vaccine.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06756269","url":"https://clinicaltrials.gov/study/NCT06756269"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shanghai-bovax-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06756269","phase":"2","setting":"A Randomised, Double-blind, Placebo and Positive Controlled, Phase 2 Clinical Trial to Evaluate the Safety and Immunogenicity of 15-valent Human Papillomavirus Recombinant Vaccine (Hansenulapolymorpha) in Healthy Chinese People Aged 9-45 Years","sponsor":"Shanghai Bovax Biotechnology Co., Ltd.","started":"2025-01-15","startedType":"actual","enrolled":330,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07454187","kind":"trial","name":"To Evaluate the Safety of SG2918 in Patients With Relapsed/Refractory Multiple Myeloma","aka":[],"tldr":"A phase 1/2 trial of SG2918 in multiple myeloma, run by Hangzhou Sumgen Biotech Co., Ltd., now recruiting.","summary":"To Evaluate the Safety of SG2918 in Patients With Relapsed/Refractory Multiple Myeloma is a phase 1/2 interventional study registered as NCT07454187 by Hangzhou Sumgen Biotech Co., Ltd., with 40 participants planned, started 2026-04-16 and due to reach its primary completion in 2027-09-30. Interventions recorded: SG2918.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07454187","url":"https://clinicaltrials.gov/study/NCT07454187"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hangzhou-sumgen-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07454187","phase":"1/2","setting":"A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG2918 for Injection in Patients With Relapsed/Refractory Multiple Myeloma","sponsor":"Hangzhou Sumgen Biotech Co., Ltd.","started":"2026-04-16","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06378242","kind":"trial","name":"To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2","aka":[],"tldr":"A phase 1/2 trial of Disitamab vedotin in bladder & urothelial cancer, run by RemeGen Co., Ltd., now recruiting.","summary":"To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2 is a phase 1/2 interventional study registered as NCT06378242 by RemeGen Co., Ltd., with 24 participants planned, started 2024-06-14 and due to reach its primary completion in 2029-03-15. Interventions recorded: Disitamab Vedotin for injection.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06378242","url":"https://clinicaltrials.gov/study/NCT06378242"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["disitamab-vedotin"],"companies":["remegen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06378242","phase":"1/2","setting":"An Single-arm, Multicenter Phase I/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2","sponsor":"RemeGen Co., Ltd.","started":"2024-06-14","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06808412","kind":"trial","name":"To Explore the Efficacy of Sintilimab Combined With Bevacizumab in Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by xiaohua li, now recruiting.","summary":"To Explore the Efficacy of Sintilimab Combined With Bevacizumab in Rectal Cancer is a phase 2, interventional study registered as NCT06808412 by xiaohua li, with a registry enrolment figure of 118 participants, started 2024-07-05 and due to reach its primary completion in 2025-05-05. Interventions recorded: sintilimab combined with bevacizumab and XELOX. Conditions listed: Rcctal Cancer. Primary outcome: assess the pathological complete response (pCR) rate of tumors after neoadjuvant chemotherapy for rectal cancer using sintilimab combined with bevacizumab. Colorectal eligibility wording from the registry: \"Rectal cancer patients who have previously received perioperative XELOX regimen treatment\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06808412","url":"https://clinicaltrials.gov/study/NCT06808412"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06808412","phase":"2","setting":"A Study on the Efficacy and Safety of Sintilimab Combined With Bevacizumab in Perioperative Neoadjuvant Chemotherapy for Locally Advanced Low Rectal Cancer","sponsor":"xiaohua li","started":"2024-07-05","startedType":"actual","enrolled":118,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07368998","kind":"trial","name":"To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer","aka":["optINAVO"],"tldr":"A phase 2 trial of Inavolisib and Fulvestrant in advanced solid tumours, run by Hoffmann-La Roche, now recruiting.","summary":"To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer is a phase 2 interventional study registered as NCT07368998 by Hoffmann-La Roche, with 80 participants planned, started 2026-02-18 and due to reach its primary completion in 2028-10-31. Interventions recorded: Inavolisib and Fulvestrant.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07368998","url":"https://clinicaltrials.gov/study/NCT07368998"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["endocrine-therapy","kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["inavolisib","fulvestrant"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07368998","phase":"2","setting":"A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer","sponsor":"Hoffmann-La Roche","started":"2026-02-18","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06290869","kind":"trial","name":"Tobacco Education and Lung Health Study (TEAL)","aka":["TEAL"],"tldr":"A phase 3 trial in lung cancer, run by Georgetown University, now recruiting.","summary":"Tobacco Education and Lung Health Study (TEAL) is a phase 3, randomised interventional study registered as NCT06290869 by Georgetown University, with a registry enrolment figure of 1188 participants, started 2024-02-22 and due to reach its primary completion in 2027-12-01. Interventions recorded: Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention; E-Referral to the Tobacco Quitline. Conditions listed: Smoking Cessation. Primary outcome: Biochemically verified smoking abstinence- MHS vs. QL-E arms; Biochemically verified smoking abstinence--continued MHS arm vs Stepped Care. Lung eligibility wording from the registry: \"* prior lung cancer,\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06290869","url":"https://clinicaltrials.gov/study/NCT06290869"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":["low-dose-ct-screening"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06290869","phase":"3","setting":"Providing Tobacco Treatment to Patients Undergoing Lung Cancer Screening at MedStar Health: A Randomized Trial (Tobacco Education and Lung Health Study)","sponsor":"Georgetown University","started":"2024-02-22","startedType":"actual","enrolled":1188,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05846789","kind":"trial","name":"Toci +/- SOC Chemo for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers","aka":[],"tldr":"A phase 2 trial of tocilizumab in triple-negative breast cancer, run by Kathy Miller, now recruiting.","summary":"Toci +/- SOC Chemo for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers is a phase 2, randomised interventional study registered as NCT05846789 by Kathy Miller, with a registry enrolment figure of 168 participants, started 2024-07-02 and due to reach its primary completion in 2027-12. Interventions recorded: SOC Chemotherapy; Tocilizumab/Tocilizumab Biosimilar. Conditions listed: Metastatic Breast Cancer; Triple Negative Breast Cancer; Estrogen-receptor-low Breast Cancer; ER Positive, HER2 Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Locally recurrent (not amenable to local therapy with curative intent) or metastatic breast cancer that is triple negative or ER-positive (ER and PR ≤ 1% weak staining)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05846789","url":"https://clinicaltrials.gov/study/NCT05846789"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["tocilizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05846789","phase":"2","setting":"A Pragmatic Phase II Trial of Chemotherapy +/- Tocilizumab for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers","sponsor":"Kathy Miller","started":"2024-07-02","startedType":"actual","enrolled":168,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04691817","kind":"trial","name":"Tocilizumab and Atezolizumab in Adults With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based T","aka":[],"tldr":"A phase 1/2 trial of atezolizumab and tocilizumab in lung cancer, run by Abramson Cancer Center at Penn Medicine, now recruiting.","summary":"Tocilizumab and Atezolizumab in Adults With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy is a phase 1/2, interventional study registered as NCT04691817 by Abramson Cancer Center at Penn Medicine, with a registry enrolment figure of 28 participants, started 2023-07-25 and due to reach its primary completion in 2026-12. Interventions recorded: Atezolizumab; Tocilizumab. Conditions listed: Lung Cancer, Nonsmall Cell. Primary outcome: Overall response rate (ORR). Lung eligibility wording from the registry: \"* Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04691817","url":"https://clinicaltrials.gov/study/NCT04691817"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["atezolizumab","tocilizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04691817","phase":"1/2","setting":"A Phase Ib-II Trial of Tocilizumab and Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy","sponsor":"Abramson Cancer Center at Penn Medicine","started":"2023-07-25","startedType":"actual","enrolled":28,"enrolledBasis":"registry","outcomes":[]},{"id":"toga","kind":"trial","name":"ToGA","aka":[],"tldr":"The trial that brought the breast-cancer drug Herceptin to stomach cancer, the first targeted therapy to improve survival in this disease.","summary":"ToGA, trial NCT01041404 sponsored by Roche and reported in the Lancet in 2010, brought the breast cancer antibody trastuzumab to stomach cancer, the first targeted therapy to improve survival in the disease. It randomised 594 patients with first-line HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma to trastuzumab plus cisplatin and a fluoropyrimidine or chemotherapy alone, met its primary overall survival endpoint, and established HER2 testing for all advanced gastric cancers and the trastuzumab-chemotherapy backbone that KEYNOTE-811 and HERIZON-GEA-01 later built on. OnCo links it to gastric and oesophageal cancer, HER2 as a target, trastuzumab, Kohei Shitara, Yung-Jue Bang and the HER2 sequence pairing. With zanidatamab now beating trastuzumab head to head, whether the ToGA backbone has been retired is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01041404","url":"https://clinicaltrials.gov/study/NCT01041404"}],"tags":[],"related":[],"cancers":["gastric","gastric-her2-positive"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["her2"],"drugs":["trastuzumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["shitara-kohei","bang-yung-jue"],"bottlenecks":[],"keyPapers":["paper-toga-trastuzumab-gastric-lancet-2010"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01041404","phase":"3","setting":"First-line HER2-positive advanced gastric/GEJ adenocarcinoma: trastuzumab + cisplatin/fluoropyrimidine vs chemotherapy","sponsor":"Roche","result":"OS 13.8 vs 11.1 months, HR 0.74.","started":"2005-09","yearReported":2010,"enrolled":594,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Trastuzumab + chemotherapy","n":294,"value":13.8},{"name":"Chemotherapy","n":290,"value":11.1}],"hr":0.74,"ci":[0.6,0.91],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61121-X/abstract"}],"replication":"Effect confirmed in real-world cohorts and as the control arm of HERIZON-GEA-01 (median PFS 8.1 months)."},{"id":"nct07468630","kind":"trial","name":"Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma","aka":["TRIUNITE-08"],"tldr":"A phase 2 trial of sintilimab in colorectal cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, now recruiting.","summary":"Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma is a phase 2, randomised interventional study registered as NCT07468630 by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, with a registry enrolment figure of 106 participants, started 2026-04-10 and due to reach its primary completion in 2026-12-31. Interventions recorded: Tolecizumab (PCSK9 Inhibitor); Sintilimab. Conditions listed: Colon Adenocarcinoma. Primary outcome: pCR. Colorectal eligibility wording from the registry: \"Pathohistologically confirmed colon adenocarcinoma with cT3c stage or above\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07468630","url":"https://clinicaltrials.gov/study/NCT07468630"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07468630","phase":"2","setting":"A Multicenter, Randomized, Open-Label, Blinded-Endpoint Phase II Study of Tolecizumab (a PCSK9 Inhibitor) Enhancing Chemoimmunotherapy as Neoadjuvant Treatment for Patients With pMMR/MSS Locally Advanced Colon Adenocarcinoma (TRIUNITE-08)","sponsor":"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","started":"2026-04-10","startedType":"estimated","enrolled":106,"enrolledBasis":"registry","outcomes":[]},{"id":"topaz-1","kind":"trial","name":"TOPAZ-1","aka":[],"tldr":"TOPAZ-1 was the first immunotherapy success in bile duct cancer, with a small median gain but a growing tail of long survivors.","summary":"TOPAZ-1, trial NCT03875235 sponsored by AstraZeneca and reported in 2022, was the first immunotherapy success in bile duct cancer, adding durvalumab to gemcitabine and cisplatin in first-line advanced biliary tract cancer. It randomised 685 patients, met its primary overall survival endpoint with a small median gain but a growing tail of long survivors, confirmed at two years and in a three-year update in 2025, and led to approval in September 2022. OnCo links it to biliary tract and gallbladder cancer, durvalumab, gemcitabine plus cisplatin, the pairing of chemotherapy with PD-1 or PD-L1 blockade, Juan W. Valle and Do-Youn Oh, and KEYNOTE-966 with pembrolizumab reproduced the class effect. Which patients populate the durable tail, and whether a biomarker can find them in advance, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03875235","url":"https://clinicaltrials.gov/study/NCT03875235"},{"label":"Updated OS (PubMed)","url":"https://pubmed.ncbi.nlm.nih.gov/38823398/"},{"label":"3-year update","url":"https://www.journal-of-hepatology.eu/article/S0168-8278(25)02201-9/fulltext"},{"label":"NICE TA944: durvalumab with gemcitabine and cisplatin for unresectable or advanced biliary tract cancer","url":"https://www.nice.org.uk/guidance/ta944"},{"label":"Imfinzi label (openFDA): TOPAZ-1 baseline tumour location","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22IMFINZI%22"},{"label":"NICE TA944: durvalumab with gemcitabine and cisplatin for biliary tract cancer (10 January 2024)","url":"https://www.nice.org.uk/guidance/ta944"},{"label":"TOPAZ-1 3-year overall survival update, J Hepatol 2025","url":"https://doi.org/10.1016/j.jhep.2025.05.003"}],"tags":[],"related":[],"cancers":["cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","gallbladder"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","gemcitabine-cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["juan-valle","oh-do-youn"],"bottlenecks":[],"keyPapers":["paper-topaz-1-nejm-evidence-2022","paper-topaz-1-lancet-gastroenterol-hepatol-2024-update"],"journals":[],"dependsOn":[],"notes":["NICE TA944 recommends durvalumab with gemcitabine and cisplatin, within its marketing authorisation, for locally advanced, unresectable or metastatic biliary tract cancer in adults; this is the routinely funded first-line immunotherapy combination on the NHS.","Gallbladder cancer: randomisation was stratified by primary tumour location (intrahepatic, extrahepatic, gallbladder) and the Imfinzi label gives the split as intrahepatic 56 percent, extrahepatic 18 percent and gallbladder 25 percent; the label and the 3-year update report benefit across all clinically relevant subgroups, with extended long-term survivors (alive 30 months or more) in 17.0 percent of the durvalumab arm and 8.7 percent of the placebo arm, but no gallbladder-specific hazard ratio is published in the sources checked. UK sites: Bristol, Cambridge, London (two), Manchester, Oxford, Romford and Sheffield (registry). NICE TA944 (10 January 2024) recommends durvalumab with gemcitabine and cisplatin for locally advanced, unresectable or metastatic biliary tract cancer, gallbladder cancer included."],"nct":"NCT03875235","phase":"3","setting":"First-line advanced biliary tract cancer: gemcitabine-cisplatin + durvalumab vs + placebo","sponsor":"AstraZeneca","result":"OS HR 0.76; 2-year OS 23.6% vs 11.5%.","started":"2019-04-16","startedType":"actual","yearReported":2022,"enrolled":685,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (updated)","primary":true,"unit":"months","arms":[{"name":"Durvalumab + GemCis","n":341,"value":12.9},{"name":"Placebo + GemCis","n":344,"value":11.3}],"hr":0.76,"ci":[0.64,0.91],"source":"https://doi.org/10.1056/EVIDoa2200015"},{"endpoint":"24-month overall survival","unit":"%","arms":[{"name":"Durvalumab + GemCis","value":23.6},{"name":"Placebo + GemCis","value":11.5}],"source":"https://doi.org/10.1056/EVIDoa2200015"},{"endpoint":"Overall survival (primary analysis)","unit":"months","arms":[{"name":"Durvalumab + GemCis","n":341},{"name":"Placebo + GemCis","n":344}],"hr":0.8,"ci":[0.66,0.97],"p":"0.021","source":"https://doi.org/10.1056/EVIDoa2200015"},{"endpoint":"36-month overall survival (3-year update, median follow-up 41.3 months)","unit":"%","arms":[{"name":"Durvalumab + GemCis","n":341,"value":14.6},{"name":"Placebo + GemCis","n":344,"value":6.9}],"hr":0.74,"ci":[0.63,0.87],"source":"https://doi.org/10.1016/j.jhep.2025.05.003"}],"replication":"KEYNOTE-966 (pembrolizumab) reproduced the class effect."},{"id":"nct00129142","kind":"trial","name":"Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy","aka":[],"tldr":"A phase 3 trial of Toremifene in Prostate cancer, run by GTx, completed.","summary":"Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy is a phase 3 interventional study registered as NCT00129142 by GTx, with 1200 participants recorded, started 2003-10 and reaching its primary completion in 2007-11. Interventions recorded: Toremifene Citrate. Conditions recorded: Prostate Cancer, Osteoporosis, Fractures.\n\nLinked to the drug Toremifene because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00129142","url":"https://clinicaltrials.gov/study/NCT00129142"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["toremifene"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00129142","phase":"3","setting":"A Randomized, Double Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy","sponsor":"GTx","started":"2003-10","enrolled":1200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07256964","kind":"trial","name":"Toripalimab Combined With Anthracycline-free or Anthracycline-containing Chemotherapy as Neoadjuvant Chemotherapy for Early Triple Negative Breast Cancer","aka":[],"tldr":"A phase 2 trial of toripalimab in triple-negative breast cancer, run by Henan Cancer Hospital, not yet recruiting.","summary":"Toripalimab Combined With Anthracycline-free or Anthracycline-containing Chemotherapy as Neoadjuvant Chemotherapy for Early Triple Negative Breast Cancer is a phase 2, randomised interventional study registered as NCT07256964 by Henan Cancer Hospital, with a registry enrolment figure of 216 participants, started 2025-11-26 and due to reach its primary completion in 2028-12-31. Interventions recorded: Toripalimab; PCb-EC; PCb. Conditions listed: TNBC - Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Pathology: Histopathologically confirmed triple-negative, invasive breast carcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07256964","url":"https://clinicaltrials.gov/study/NCT07256964"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07256964","phase":"2","setting":"A Prospective, Randomized Controlled, Multicenter Phase II Clinical Study of Toripalimab Combined With PCb-EC Regimen (Albumin Paclitaxel + Carboplatin Followed by Epirubicin + Cyclophosphamide) or PCb Regimen (Albumin Paclitaxel + Carboplatin) as Neoadjuvant Therapy for Triple-Negative Breast Cancer","sponsor":"Henan Cancer Hospital","started":"2025-11-26","startedType":"estimated","enrolled":216,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06717464","kind":"trial","name":"Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of toripalimab and capecitabine in gallbladder cancer and other biliary tract cancers, run by Tianjin Medical University Cancer Institute and Hospital, active and no longer recruiting.","summary":"Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer is a phase 2, randomised interventional study registered as NCT06717464 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 110 participants, started 2024-11-12 and due to reach its primary completion in 2026-12-31. Interventions recorded: Capecitabine, Toripalimab. Conditions listed: Gallbladder Cancer, Hilar Cholangiocarcinoma, Distal Cholangiocarcinoma. Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06717464","url":"https://clinicaltrials.gov/study/NCT06717464"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["toripalimab","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06717464","phase":"2","setting":"Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer, Phase II, Single-center, Randomized Controlled Trial","sponsor":"Tianjin Medical University Cancer Institute and Hospital","started":"2024-11-12","startedType":"actual","enrolled":110,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06441344","kind":"trial","name":"Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell","aka":["SCLC"],"tldr":"A phase 3 trial of toripalimab and anlotinib in lung cancer, run by Taizhou Hospital, not yet recruiting.","summary":"Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell is a phase 3, randomised interventional study registered as NCT06441344 by Taizhou Hospital, with a registry enrolment figure of 136 participants, started 2024-07-01 and due to reach its primary completion in 2026-05-01. Interventions recorded: Toripalimab plus Anlotinib; Toripalimab. Conditions listed: SCLC; Maintenance Treatment. Primary outcome: progression free survival(PFS); overal survival time(OS). Lung eligibility wording from the registry: \"* Confirmed as small cell lung cancer (SCLC) by histopathology or cytology and diagnosed as extensive after systemic evaluation\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06441344","url":"https://clinicaltrials.gov/study/NCT06441344"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["toripalimab","anlotinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06441344","phase":"3","setting":"First-line Etoposide Combined With Platinum-based Chemotherapy Followed by Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell Carcinoma - A Randomized, Controlled, Multicenter Phase III Clinical Study","sponsor":"Taizhou Hospital","started":"2024-07-01","startedType":"estimated","enrolled":136,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06903858","kind":"trial","name":"Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer","aka":["PICC-3"],"tldr":"A phase 2 trial of toripalimab and celecoxib in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer is a phase 2, interventional study registered as NCT06903858 by Sun Yat-sen University, with a registry enrolment figure of 105 participants, started 2025-06-01 and due to reach its primary completion in 2028-04-01. Interventions recorded: Toripalimab plus celecoxib; Non-operative management; Curative-intent surgery. Conditions listed: Colorectal Cancer; Microsatellite Instability High; Mismatch Repair Deficiency. Primary outcome: Event-free survival (EFS). Colorectal eligibility wording from the registry: \"Histologically confirmed colorectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06903858","url":"https://clinicaltrials.gov/study/NCT06903858"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab","celecoxib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06903858","phase":"2","setting":"Toripalimab Plus Celecoxib With Response-adapted Non-operative Management for Mismatch Repair-deficient or Microsatellite Instability-high Locally Advanced Colorectal Cancer (PICC-3): a Multicenter, Single-arm, Phase 2 Trial","sponsor":"Sun Yat-sen University","started":"2025-06-01","startedType":"actual","enrolled":105,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07819578","kind":"trial","name":"Toripalimab Plus Sacituzumab Tirumotecan as Neoadjuvant Therapy for Resectable NSCLC","aka":[],"tldr":"A phase 2 trial of toripalimab and sacituzumab tirumotecan in lung cancer, run by Shaodong Hong, not yet recruiting.","summary":"Toripalimab Plus Sacituzumab Tirumotecan as Neoadjuvant Therapy for Resectable NSCLC is a phase 2, interventional study registered as NCT07819578 by Shaodong Hong, with a registry enrolment figure of 30 participants, started 2026-10-01 and due to reach its primary completion in 2028-12-01. Interventions recorded: Toripalimab; Sacituzumab Tirumotecan (SKB264). Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Pathological Complete Response (pCR) Rate. Lung eligibility wording from the registry: \"* Histologically/cytologically confirmed, treatment-naive, resectable or potentially resectable NSCLC: stage II-IIIA and selected IIIB (T3N2, T4N2) per IASLC/UICC TNM 9th edition\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07819578","url":"https://clinicaltrials.gov/study/NCT07819578"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["toripalimab","sacituzumab-tirumotecan"],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07819578","phase":"2","setting":"A Phase II Study of Toripalimab Combined With Sacituzumab Tirumotecan as Neoadjuvant Therapy for Resectable Non-Small Cell Lung Cancer","sponsor":"Shaodong Hong","started":"2026-10-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"tosca","kind":"trial","name":"TOSCA","aka":["Three Or Six Colon Adjuvant"],"tldr":"The Italian duration trial could not show that three months was as good as six, and it is the reason the pooled answer depends on which drug combination is used.","summary":"TOSCA accrued 3,759 patients with stage II or III colon cancer to three or six months of FOLFOX4 or CAPOX. At a median seven years the hazard ratio for relapse-free survival of three against six months was 1.13 (95% CI 0.99 to 1.29), crossing the prespecified non-inferiority limit of 1.20, so inferiority of the shorter arm could not be ruled out; the hazard ratio for overall survival was 1.09 (0.93 to 1.26, p=0.288 for superiority) with no significant difference between groups. TOSCA pulls against SCOT in the IDEA pooled analysis, and the difference between their regimen mixes, mostly CAPOX in SCOT and more FOLFOX in TOSCA, is part of why three months holds for CAPOX and not for FOLFOX.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00646607","url":"https://clinicaltrials.gov/study/NCT00646607"},{"label":"TOSCA: overall survival with 3 or 6 months of adjuvant chemotherapy (Annals of Oncology 2021)","url":"https://doi.org/10.1016/j.annonc.2020.10.477"}],"tags":[],"related":[],"cancers":["colorectal","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","capox","oxaliplatin","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":["idea-collaboration","scot"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00646607","phase":"3","setting":"Stage II or III colon cancer after resection: three months of FOLFOX4 or CAPOX against six months","sponsor":"Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente","result":"Relapse-free survival hazard ratio 1.13 for three against six months, crossing the non-inferiority limit; no overall survival difference.","started":"2007-06","yearReported":2021,"enrolled":3759,"enrolledBasis":"randomised","enrolledNote":"The registry lists 3,756 participants; the Annals of Oncology report accrued 3,759 between June 2007 and March 2013.","outcomes":[{"endpoint":"Relapse-free survival","primary":true,"unit":"hazard ratio","arms":[{"name":"3 months","value":1.13},{"name":"6 months","value":1}],"hr":1.13,"ci":[0.99,1.29],"p":"0.380 for non-inferiority","source":"https://doi.org/10.1016/j.annonc.2020.10.477"}]},{"id":"nct05998122","kind":"trial","name":"Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by The First Hospital of Jilin University, not yet recruiting.","summary":"Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study is a phase 2, interventional study registered as NCT05998122 by The First Hospital of Jilin University, with a registry enrolment figure of 45 participants, started 2023-09-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: nCRT → (CapeOX+Sintilimab)×6 → Surgery/W&W. Conditions listed: Locally Advanced Rectal Cancer; Total Neoadjuvant Treatment; Anti-PD-1. Primary outcome: Complete response rate (CR). Colorectal eligibility wording from the registry: \"Pathologically diagnosed rectal adenocarcinoma: differentiated into Grade 1-3, that is, high, medium, and poorly differentiated tubular adenocarcinoma; classified as pMMR/MSS\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05998122","url":"https://clinicaltrials.gov/study/NCT05998122"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05998122","phase":"2","setting":"Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal High-Risk or Very High-Risk Patients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study","sponsor":"The First Hospital of Jilin University","started":"2023-09-01","startedType":"estimated","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07810114","kind":"trial","name":"Total Neoadjuvant mFOLFOX6 Plus Suvemcitug and Enlonstobart With Selective Omission of Pelvic Radiotherapy for High-Risk Mid-Rectal Locally Advanced Rectal Canc","aka":["SPARE"],"tldr":"A phase 2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"Total Neoadjuvant mFOLFOX6 Plus Suvemcitug and Enlonstobart With Selective Omission of Pelvic Radiotherapy for High-Risk Mid-Rectal Locally Advanced Rectal Cancer is a phase 2, interventional study registered as NCT07810114 by Fudan University, with a registry enrolment figure of 52 participants, started 2026-08-28 and due to reach its primary completion in 2027-12-01. Interventions recorded: mFOLFOX6; Suvemcitug; Enlonstobart; Pelvic Chemoradiotherapy; Total Mesorectal Excision. Conditions listed: Rectal Cancer. Primary outcome: Pathologic Complete Response Rate. Colorectal eligibility wording from the registry: \"Histologically confirmed rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07810114","url":"https://clinicaltrials.gov/study/NCT07810114"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07810114","phase":"2","setting":"A Phase II Study of Total Neoadjuvant mFOLFOX6 Plus Suvemcitug and Enlonstobart With Selective Omission of Pelvic Radiotherapy for High-Risk Mid-Rectal Locally Advanced Rectal Cancer With MSS Status","sponsor":"Fudan University","started":"2026-08-28","startedType":"estimated","enrolled":52,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06758830","kind":"trial","name":"Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.","aka":[],"tldr":"A phase 2/3 trial in colorectal cancer, run by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos, now recruiting.","summary":"Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer. is a phase 2/3, randomised interventional study registered as NCT06758830 by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos, with a registry enrolment figure of 400 participants, started 2025-01-06 and due to reach its primary completion in 2029-12-27. Interventions recorded: Radiation Therapy; Chemoradiotherapy; Consolidation Chemotherapy; Surgery; Part two; Adjuvant treatment. Conditions listed: Rectal Cancer; Total Neoadjuvant Treatment; Neoadjuvant Therapy; Radiotherapy; Chemotherapy; Organ Preservation; Radiotherapy Side Effect; Chemotherapy Side Effects; Chemoradiotherapy; Low Anterior Resection Syndrome; Quality of Life. Primary outcome: Postoperative complications; TNT toxicity; Mortality rate. Colorectal eligibility wording from the registry: \"* Pathologically confirmed rectal adenocarcinoma\". Sites: Lithuania. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06758830","url":"https://clinicaltrials.gov/study/NCT06758830"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06758830","phase":"2/3","setting":"Total Neoadjuvant Therapy for Rectal Cancer - a New Standard of Care?","sponsor":"National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos","started":"2025-01-06","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06162650","kind":"trial","name":"Total Neoadjuvant Therapy in Rectal Cancer","aka":[],"tldr":"A phase 2 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by National Cheng-Kung University Hospital, now recruiting.","summary":"Total Neoadjuvant Therapy in Rectal Cancer is a phase 2, interventional study registered as NCT06162650 by National Cheng-Kung University Hospital, with a registry enrolment figure of 42 participants, started 2023-11-16 and due to reach its primary completion in 2026-11-16. Interventions recorded: Short-course radiotherapy; mFOLFOX6. Conditions listed: Rectal Cancer. Primary outcome: Complete response (CR) rate. Colorectal eligibility wording from the registry: \"* Histologically confirmed diagnosis of adenocarcinoma of the rectum;\". Sites: Taiwan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06162650","url":"https://clinicaltrials.gov/study/NCT06162650"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["folfox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06162650","phase":"2","setting":"A Phase II Study of Total Neoadjuvant Therapy in Rectal Cancer","sponsor":"National Cheng-Kung University Hospital","started":"2023-11-16","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04643366","kind":"trial","name":"Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Virginia Commonwealth University, now recruiting.","summary":"Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer is a phase 2, interventional study registered as NCT04643366 by Virginia Commonwealth University, with a registry enrolment figure of 64 participants, started 2021-01-28 and due to reach its primary completion in 2030-01-31. Interventions recorded: Chemotherapy; Radiation Therapy. Conditions listed: Rectal Cancer. Primary outcome: Three-year disease free survival (DFS). Colorectal eligibility wording from the registry: \"* Pathologic diagnosis of adenocarcinoma of the rectum (diagnosis by tissue biopsy) within 90 days prior to registration\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04643366","url":"https://clinicaltrials.gov/study/NCT04643366"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04643366","phase":"2","setting":"Phase 2 Study of Total Neoadjuvant mFOLFOX and Short-Course Radiotherapy in Resectable Rectal Cancer","sponsor":"Virginia Commonwealth University","started":"2021-01-28","startedType":"actual","enrolled":64,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07214142","kind":"trial","name":"Total Neoadjuvant Therapy With PD-1 for Locally Advcancer Rectal Cancer","aka":["TNT-Immunity"],"tldr":"A phase 2 trial in colorectal cancer, run by The First Affiliated Hospital of University of Science and Technology of China, not yet recruiting.","summary":"Total Neoadjuvant Therapy With PD-1 for Locally Advcancer Rectal Cancer is a phase 2, interventional study registered as NCT07214142 by The First Affiliated Hospital of University of Science and Technology of China, with a registry enrolment figure of 30 participants, started 2025-10-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: PD-1. Conditions listed: Rectal Cancer Patients. Primary outcome: pathological complete response rate. Colorectal eligibility wording from the registry: \"Pathologically confirmed rectal adenocarcinoma;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07214142","url":"https://clinicaltrials.gov/study/NCT07214142"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07214142","phase":"2","setting":"Efficacy and Safety of Total Neoadjuvant Chemoradiotherapy Combined With PD-1 Therapy for Locally Advanced Rectal Cancer With High Risk of Recurrence","sponsor":"The First Affiliated Hospital of University of Science and Technology of China","started":"2025-10-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06229041","kind":"trial","name":"Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi)","aka":["TNTi"],"tldr":"A phase 3 trial in colorectal cancer, run by Peking University Cancer Hospital & Institute, now recruiting.","summary":"Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi) is a phase 3, randomised interventional study registered as NCT06229041 by Peking University Cancer Hospital & Institute, with a registry enrolment figure of 472 participants, started 2023-03-29 and due to reach its primary completion in 2027-10-01. Interventions recorded: Camrelizumab ＋Immunotherapy. Conditions listed: Rectal Cancer. Primary outcome: The PCR rate between total neoadjuvant treatment ±immunotherapy. Colorectal eligibility wording from the registry: \"colorectal adenocarcinoma confirmed by pathology\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06229041","url":"https://clinicaltrials.gov/study/NCT06229041"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06229041","phase":"3","setting":"Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi)","sponsor":"Peking University Cancer Hospital & Institute","started":"2023-03-29","startedType":"actual","enrolled":472,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06099951","kind":"trial","name":"Total Neoadjuvant Treatment for pMMR Locally Advanced Low Rectal Cancer: Anti-PD-1 Antibody With FOLFOXIRI and Preoperative Radiation Therapy","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"Total Neoadjuvant Treatment for pMMR Locally Advanced Low Rectal Cancer: Anti-PD-1 Antibody With FOLFOXIRI and Preoperative Radiation Therapy is a phase 2, interventional study registered as NCT06099951 by Sun Yat-sen University, with a registry enrolment figure of 53 participants, started 2023-11-01 and due to reach its primary completion in 2024-09-01. Interventions recorded: Serplulimab + FOLFOXIRI; Radiation therapy. Conditions listed: Colorectal Cancer. Primary outcome: Complete tumor response rate.. Colorectal eligibility wording from the registry: \"* The pathological confirmation is rectal adenocarcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06099951","url":"https://clinicaltrials.gov/study/NCT06099951"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06099951","phase":"2","setting":"Single Arm Phase II Clinical Trial of Recombinant Humanized Anti PD-1 Monoclonal Antibody and FOLFOXIRI Regimen Combined With Preoperative Intensity Modulated Radiation Therapy as the Total Neoadjuvant Treatment for pMMR Locally Advanced Low Rectal Cancer","sponsor":"Sun Yat-sen University","started":"2023-11-01","startedType":"estimated","enrolled":53,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06940388","kind":"trial","name":"Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer.","aka":["TOTAL"],"tldr":"A phase 2 trial of tislelizumab in colorectal cancer, run by brenner baruch, now recruiting.","summary":"Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer. is a phase 2, randomised interventional study registered as NCT06940388 by brenner baruch, with a registry enrolment figure of 134 participants, started 2025-07-23 and due to reach its primary completion in 2029-08. Interventions recorded: Tislelizumab; Total neoadjuvant therapy (TNT). Conditions listed: Locally Advanced Rectal Cancer (LARC). Primary outcome: 3-year total mesorectal excision (TME) free survival rates. Colorectal eligibility wording from the registry: \"* No prior chemotherapy, immunotherapy, radiotherapy or surgery for rectal cancer\". Sites: Germany, Israel. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06940388","url":"https://clinicaltrials.gov/study/NCT06940388"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06940388","phase":"2","setting":"Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer: An Open-label Randomized Controlled Phase II Study (The TOTAL Trial)","sponsor":"brenner baruch","started":"2025-07-23","startedType":"actual","enrolled":134,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07662031","kind":"trial","name":"Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of tovecimig, fOLFIRI (5-FU, leucovorin, irinotecan), fOLFOX (5-FU, leucovorin, oxaliplatin) and fluorouracil (5-FU) in colorectal cancer, run by Washington University School of Medicine, not yet recruiting.","summary":"Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT07662031 by Washington University School of Medicine, with a registry enrolment figure of 25 participants, started 2026-08-31 and due to reach its primary completion in 2030-08-31. Interventions recorded: Tovecimig; Irinotecan; Leucovorin; 5-Fluorouracil (5-FU). Conditions listed: Colorectal Cancer; Metastatic Colorectal Cancer. Primary outcome: Overall Response Rate (ORR). Colorectal eligibility wording from the registry: \"Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07662031","url":"https://clinicaltrials.gov/study/NCT07662031"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["tovecimig","folfiri","folfox","fluorouracil"],"companies":["compass-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07662031","phase":"2","setting":"A Phase 2 Clinical Trial of Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer","sponsor":"Washington University School of Medicine","started":"2026-08-31","startedType":"estimated","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"tower","kind":"trial","name":"TOWER","aka":[],"tldr":"The first randomised proof that a T-cell engager beats chemotherapy: blinatumomab nearly doubled survival in relapsed adult ALL.","summary":"TOWER, trial NCT02013167 sponsored by Amgen and published in the New England Journal of Medicine in 2017, was the first randomised proof that a T-cell engager beats chemotherapy: blinatumomab nearly doubled survival in relapsed or refractory Philadelphia-negative B-cell acute lymphoblastic leukaemia in adults. It randomised 405 patients to blinatumomab or standard salvage chemotherapy, met its primary overall survival endpoint, doubled the complete remission rate within twelve weeks, and most blinatumomab responders became MRD-negative, converting the 2014 accelerated approval to full approval. OnCo links it to acute lymphoblastic leukaemia, T-cell engagers, CD19 and CD3 as targets and blinatumomab. Whether blinatumomab can replace chemotherapy blocks altogether is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02013167","url":"https://clinicaltrials.gov/study/NCT02013167"}],"tags":[],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":["t-cell-engager"],"targets":["cd19","cd3"],"drugs":["blinatumomab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02013167","phase":"3","setting":"Relapsed or refractory Ph-negative B-ALL, adults: blinatumomab vs standard salvage chemotherapy","sponsor":"Amgen","result":"OS 7.7 vs 4.0 months; HR 0.71.","started":"2014-01-03","startedType":"actual","yearReported":2017,"enrolled":405,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Blinatumomab","n":271,"value":7.7},{"name":"Chemotherapy","n":134,"value":4}],"hr":0.71,"ci":[0.55,0.93],"p":"0.01","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1609783"},{"endpoint":"Complete remission within 12 weeks","unit":"%","arms":[{"name":"Blinatumomab","value":34},{"name":"Chemotherapy","value":16}],"source":"https://doi.org/10.1056/NEJMoa1609783"}],"replication":"RIALTO (children) and BLAST (MRD-positive) reproduced high MRD-negative remission rates; E1910 and AALL1731 confirmed benefit frontline."},{"id":"tpextreme","kind":"trial","name":"TPExtreme (GORTEC 2014-01)","aka":["TPExtreme","GORTEC 2014-01"],"tldr":"TPExtreme compared a shorter, docetaxel-based version of the standard EXTREME chemotherapy for advanced head and neck cancer with the original; patients lived about as long on either, and the shorter regimen was easier to tolerate, so it became an accepted alternative.","summary":"The EXTREME regimen of platinum, fluorouracil and cetuximab was the first-line standard for recurrent or metastatic head and neck squamous cell carcinoma for a decade but requires six cycles of infusional fluorouracil. TPExtreme, a French randomised phase 2 trial of 541 patients, compared TPEx (docetaxel, cisplatin and cetuximab for four cycles with G-CSF support) against EXTREME, both followed by cetuximab maintenance. The primary endpoint was overall survival.\n\nOverall survival was not superior with TPEx, so the primary endpoint was not met, but survival was similar, the regimen was shorter, and it caused fewer severe adverse events. TPEx is now an accepted first-line chemotherapy backbone, in particular for patients with rapidly progressing disease or after immunotherapy, since pembrolizumab-based regimens displaced EXTREME in first line after KEYNOTE-048.","status":"mixed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02268695","url":"https://clinicaltrials.gov/study/NCT02268695"}],"tags":["subtype-trials"],"related":[],"cancers":["recurrent-metastatic-hnscc","head-and-neck"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel","cisplatin","cetuximab","fluorouracil"],"companies":["gortec"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["joel-guigay"],"bottlenecks":[],"keyPapers":["paper-tpextreme-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02268695","phase":"2","setting":"Untreated recurrent or metastatic head and neck squamous cell carcinoma: the TPEx regimen (docetaxel, cisplatin and cetuximab, four cycles) against the EXTREME regimen (fluorouracil, cisplatin and cetuximab, six cycles), each followed by cetuximab maintenance","sponsor":"GORTEC (Groupe Oncologie Radiotherapie Tete et Cou)","result":"TPEx did not improve overall survival over EXTREME, but gave similar survival with a shorter schedule and less toxicity.","started":"2014-10-10","startedType":"actual","yearReported":2021,"enrolled":541,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"TPEx (docetaxel, cisplatin, cetuximab)","n":269,"value":14.5,"note":"Median follow-up 34.4 months"},{"name":"EXTREME (platinum, fluorouracil, cetuximab)","n":270,"value":13.4}],"hr":0.89,"ci":[0.74,1.08],"p":"0.23","source":"https://doi.org/10.1016/S1470-2045(20)30755-5"},{"endpoint":"Grade 3 or worse adverse events during chemotherapy","unit":"%","arms":[{"name":"TPEx (docetaxel, cisplatin, cetuximab)","n":263,"value":81},{"name":"EXTREME (platinum, fluorouracil, cetuximab)","n":265,"value":93}],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(20)30755-5"}]},{"id":"nct07044908","kind":"trial","name":"TQB2922 and TAS-102 Tablets for Injection With or Without Bevacizumab in Chemotherapy-failed RAS/BRAF Wild-type Advanced Colorectal Cancer","aka":[],"tldr":"A phase 1/2 trial of TQB2922 in colorectal cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., now recruiting.","summary":"TQB2922 and TAS-102 Tablets for Injection With or Without Bevacizumab in Chemotherapy-failed RAS/BRAF Wild-type Advanced Colorectal Cancer is a phase 1/2 interventional study registered as NCT07044908 by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., with 72 participants planned, started 2025-07-30 and due to reach its primary completion in 2026-07. Interventions recorded: TQB2922 injection ± TAS-102 tablets, TQB2922 injection+TAS-102 tablets ± Bevacizumab. Conditions listed: RAS/BRAF Wild Type Colorectal Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07044908","url":"https://clinicaltrials.gov/study/NCT07044908"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb2922"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07044908","phase":"1/2","setting":"A Phase Ib/II Clinical Study Evaluating TQB2922 for Injection and Chemotherapy in Combination With or Without Bevacizumab in Subjects With RAS/BRAF Wild-Type Advanced Colorectal Cancer Who Have Failed Chemotherapy","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","started":"2025-07-30","startedType":"actual","enrolled":72,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07047365","kind":"trial","name":"TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer","aka":[],"tldr":"A phase 3 trial of TQB2930 and Trastuzumab in HER2-positive breast cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., now recruiting.","summary":"TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer is a phase 3 interventional study registered as NCT07047365 by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., with 416 participants planned, started 2025-07-25 and due to reach its primary completion in 2028-06. Interventions recorded: TQB2930+ chemotherapy and Trastuzumab+ chemotherapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07047365","url":"https://clinicaltrials.gov/study/NCT07047365"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["tqb2930","trastuzumab"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07047365","phase":"3","setting":"A Randomized, Open-label, Parallel-controlled, Multicenter Phase III Clinical Study Evaluating TQB2930 Combined With Investigator's Choice of Chemotherapy Versus Trastuzumab Combined With Investigator's Choice of Chemotherapy in the Treatment of HER2-Positive Advanced Breast Cancer","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","started":"2025-07-25","startedType":"actual","enrolled":416,"enrolledBasis":"registry","outcomes":[]},{"id":"tracc","kind":"trial","name":"TRACC","aka":["Tracking mutations in cell free tumour DNA to predict relapse in early colorectal cancer"],"tldr":"A UK study following 1,000 people after bowel cancer surgery with repeated blood tests for tumour DNA, to see how well a positive predicts the cancer coming back and whether the result can guide chemotherapy.","summary":"TRACC is the Royal Marsden-led UK programme tracking ctDNA after surgery for early colorectal cancer. The registry lists it as an observational study of 1,000 participants that started on 5 December 2016, still recruiting, with a primary completion date of 31 July 2029 and study completion of 31 July 2031. It is one of the three large national colorectal programmes (with CIRCULATE-Japan and CIRCULATE-US) whose readouts decide whether ctDNA-guided adjuvant therapy becomes standard outside a trial.","status":"recruiting","asOf":"2026-09-21","links":[{"label":"ClinicalTrials.gov NCT04050345","url":"https://clinicaltrials.gov/study/NCT04050345"}],"tags":["ctdna-roadmap"],"related":["dynamic","circulate-japan","circulate-us","ctdna-tests"],"cancers":["colorectal"],"sections":[],"technologies":["mrd-testing","liquid-biopsy"],"targets":[],"drugs":[],"companies":[],"institutions":["royal-marsden","bowel-cancer-uk"],"pathways":[],"terms":["mrd","ctdna"],"trials":["dynamic-iii","altair"],"people":["naureen-starling","ian-chau"],"bottlenecks":[],"keyPapers":["paper-tracc-clin-cancer-res-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04050345","phase":"observational","setting":"Early colorectal cancer after curative surgery in the United Kingdom: serial ctDNA to predict relapse, with a later part that uses the result to guide adjuvant chemotherapy","sponsor":"Royal Marsden NHS Foundation Trust","started":"2016-12-05","startedType":"actual","enrolled":1000,"enrolledBasis":"registry","outcomes":[]},{"id":"tracerx","kind":"trial","name":"TRACERx","aka":["TRAcking non-small cell lung Cancer Evolution through therapy (Rx)","NCT01888601"],"tldr":"The British study that followed lung cancers through time and space, region by region, and showed that a tumour is not one thing: the late-arriving, scattered changes are the ones that predict relapse.","summary":"TRACERx, led by Charles Swanton at the UCL Cancer Institute and the Francis Crick Institute with Mariam Jamal-Hanjani as lead clinician, took multiple regions from each resected lung cancer and sequenced them. The first 100 tumours, across 327 regions, showed that driver mutations in EGFR, MET, BRAF and TP53 were almost always clonal, but that heterogeneous drivers arriving later in evolution were present in more than three quarters of tumours, and that elevated copy-number heterogeneity carried a hazard ratio of 4.9 for recurrence or death.\n\nThe 421-patient analysis found 22 of 40 common cancer genes under significant subclonal selection in adenocarcinoma, subclonal whole-genome doubling in 19 percent of tumours, and, strikingly, that 8 percent of lung adenocarcinomas in people with a smoking history carried no tobacco mutational signature and behaved molecularly like never-smoker tumours. The PEACE autopsy programme extended the work to death: 501 samples from 24 people covering 70 percent of the metastases visible on imaging showed that in 62.5 percent of patients several primary subclones disseminated independently, and that more than half the metastases sampled had been seeded by other metastases rather than by the primary. The same group's air pollution work then showed oncogenic EGFR variants in 18 percent of histologically normal lung tissue, and a mechanism by which particulates promote them.","status":"positive","asOf":"2026-09-25","links":[{"label":"New England Journal of Medicine 2017","url":"https://europepmc.org/article/MED/28445112"},{"label":"Nature 2023","url":"https://europepmc.org/article/MED/37046096"},{"label":"Nature 2026 (PEACE)","url":"https://europepmc.org/article/MED/42056508"},{"label":"NIHR Be Part of Research","url":"https://bepartofresearch.nihr.ac.uk/results/search-results?query=TRACERx%20lung"}],"tags":["uk","lung","tumour-evolution"],"related":[],"cancers":["nsclc","lung-cancer","lung-adenocarcinoma"],"sections":["diagnostics"],"technologies":["liquid-biopsy"],"targets":[],"drugs":[],"companies":[],"institutions":["uclh","francis-crick"],"pathways":[],"terms":[],"trials":[],"people":["charles-swanton"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01888601","phase":"observational","setting":"Multiregion whole-exome and whole-genome sequencing of resected non-small-cell lung cancer, with longitudinal circulating tumour DNA and, through the PEACE autopsy programme, sampling at death","sponsor":"University College London, funded by Cancer Research UK","result":"Copy-number heterogeneity predicted recurrence or death with a hazard ratio of 4.9; 8 percent of adenocarcinomas in people with a smoking history carried no tobacco signature; in the autopsy programme more than half the metastases sampled were seeded by other metastases.","started":"2014-04","startedType":"actual","yearReported":2023,"enrolled":421,"enrolledBasis":"analysed","enrolledNote":"The 2023 Nature paper analysed 1,644 tumour regions from the first 421 prospectively enrolled patients; the cohort recruited 842 in total.","outcomes":[]},{"id":"nct06951399","kind":"trial","name":"Tracking T-Cell Responses to Evaluate Pembrolizumab Effectiveness in Advanced Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of pembrolizumab in lung cancer, run by Rabin Medical Center, not yet recruiting.","summary":"Tracking T-Cell Responses to Evaluate Pembrolizumab Effectiveness in Advanced Non-Small Cell Lung Cancer is a phase 2, interventional study registered as NCT06951399 by Rabin Medical Center, with a registry enrolment figure of 30 participants, started 2025-09-01 and due to reach its primary completion in 2027-08-30. Interventions recorded: Pembrolizumab (KEYTRUDA®). Conditions listed: NSCLC (Advanced Non-small Cell Lung Cancer); NSCLC Stage IV Without EGFR/ALK Mutation; NSCLC Adenocarcinoma. Primary outcome: Change in T-cell Receptor (TCR) Repertoire Clonality and Diversity Relative to Disease Response Assessed by RECIST v1.1. Lung eligibility wording from the registry: \"* Histologically confirmed diagnosis of NSCLC adenocarcinoma stage IV or unresectable stage III\". Sites: Israel. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06951399","url":"https://clinicaltrials.gov/study/NCT06951399"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","alk-positive-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06951399","phase":"2","setting":"T-Cell Repertoire Sequencing: Assessing Pembrolizumab Efficacy in Advanced Non-Small Lung Cancer","sponsor":"Rabin Medical Center","started":"2025-09-01","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"train-2","kind":"trial","name":"TRAIN-2","aka":[],"tldr":"TRAIN-2 showed that HER2-positive breast cancer can be treated before surgery without an anthracycline: carboplatin and paclitaxel with the two HER2 antibodies made the tumour disappear as often as an anthracycline regimen did, with less harm to the heart.","summary":"TRAIN-2, trial NCT01996267 run by the Dutch Breast Cancer Research Group and published in the Lancet Oncology in 2018, randomised 438 patients with stage II or III HER2-positive breast cancer to nine cycles of carboplatin and paclitaxel with trastuzumab and pertuzumab, or to three cycles of fluorouracil, epirubicin and cyclophosphamide with the antibodies followed by six cycles of the same carboplatin-paclitaxel regimen. Pathological complete response in breast and axilla was 67 percent without the anthracycline and 68 percent with it, and the anthracycline arm had more febrile neutropenia and falls in left ventricular ejection fraction. Three-year event-free survival was 93.5 percent without and 92.7 percent with the anthracycline in the 2021 follow-up, and anthracycline-free dual-blockade regimens became the usual neoadjuvant approach in Europe. Whether a shorter or de-escalated regimen matches nine cycles is the question that followed.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01996267","url":"https://clinicaltrials.gov/study/NCT01996267"},{"label":"van Ramshorst et al., TRAIN-2 (Lancet Oncology 2018)","url":"https://doi.org/10.1016/S1470-2045(18)30570-9"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":["her2"],"drugs":["carboplatin","paclitaxel","trastuzumab","pertuzumab","epirubicin","cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":["pcr","dual-her2-blockade"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-train-2-lancet-oncol-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01996267","phase":"3","setting":"Stage II to III HER2-positive breast cancer: neoadjuvant carboplatin and paclitaxel with trastuzumab and pertuzumab, with or without three cycles of anthracycline first","sponsor":"Dutch Breast Cancer Research Group (BOOG)","result":"Pathological complete response 67% without anthracycline vs 68% with; 3-year event-free survival 93.5% vs 92.7%.","started":"2013-12","yearReported":2018,"enrolled":438,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathological complete response (breast and axilla)","primary":true,"unit":"%","arms":[{"name":"Carboplatin-paclitaxel + trastuzumab + pertuzumab","n":219,"value":67},{"name":"FEC then carboplatin-paclitaxel + trastuzumab + pertuzumab","n":219,"value":68}],"source":"https://doi.org/10.1016/S1470-2045(18)30570-9"}],"replication":"Consistent with TRYPHAENA, in which anthracycline-free TCHP gave similar pathological complete response rates."},{"id":"nct06456138","kind":"trial","name":"Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC","aka":[],"tldr":"A phase 1/2 trial of trametinib, anlotinib and tislelizumab in lung cancer, run by Shanghai Chest Hospital, not yet recruiting.","summary":"Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC is a phase 1/2, interventional study registered as NCT06456138 by Shanghai Chest Hospital, with a registry enrolment figure of 60 participants, started 2024-07-01 and due to reach its primary completion in 2026-06-30. Interventions recorded: Trametinib; Anlotinib; Tislelizumab. Conditions listed: KRAS Mutation-Related Tumors; Advanced Lung Cancer; Refractory Tumor. Primary outcome: RP2D; PFS. Lung eligibility wording from the registry: \"According to the 8th edition of the AJCC/UICC TNM staging system for NSCLC, patients with locally advanced (stage III B/III C), metastatic or recurrent (stage IV) NSCLC confirmed by histology or cytology who are unable to undergo surgery and radical concomitant radiochemotherapy and are confirmed to\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06456138","url":"https://clinicaltrials.gov/study/NCT06456138"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["trametinib","anlotinib","tislelizumab"],"companies":["beone","sino-biopharm","novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06456138","phase":"1/2","setting":"Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant Advanced Non-small Cell Lung Cancer Patients: a Multi-center, Open-label, Phase 1/2 Study","sponsor":"Shanghai Chest Hospital","started":"2024-07-01","startedType":"estimated","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03755739","kind":"trial","name":"Trans-Artery/Intra-Tumor Infusion of Checkpoint Inhibitors Plus Chemodrug for Immunotherapy of Advanced Solid Tumors","aka":[],"tldr":"A phase 2/3 trial in pancreatic cancer, run by Second Affiliated Hospital of Guangzhou Medical University, now recruiting.","summary":"Trans-Artery/Intra-Tumor Infusion of Checkpoint Inhibitors Plus Chemodrug for Immunotherapy of Advanced Solid Tumors is a phase 2/3, interventional study registered as NCT03755739 by Second Affiliated Hospital of Guangzhou Medical University, with a registry enrolment figure of 200 participants, started 2018-11-01 and due to reach its primary completion in 2033-11-01. Interventions recorded: Checkpoint inhibitor (CPI) such as Pembrolizumab plus chemotherapy. Conditions listed: Hepatocarcinoma; Lung Cancer; Melanoma; Renal Cancer; Head and Neck Cancer; Pancreas Cancer; Ovarian Cancer; Colo-rectal Cancer; Cervical Cancer; Breast Cancer. Primary outcome: Overall survival; Complete response (CR) rate before or at Month 6. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03755739","url":"https://clinicaltrials.gov/study/NCT03755739"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03755739","phase":"2/3","setting":"A Phase II/III Trial of Comparison of Benefit of Administration of Checkpoint Inhibitors Plus Chemodrug Via Artery or Fine Needle to Tumor Versus Vein for Immunotherapy of Advanced Solid Tumors","sponsor":"Second Affiliated Hospital of Guangzhou Medical University","started":"2018-11-01","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02762266","kind":"trial","name":"Transarterial Chemoembolization Compared With Stereotactic Body Radiation Therapy or Stereotactic Ablative Radiation Therapy in Treating Patients With Residual or Recurrent Liver Cancer Undergone Initial Transarterial Chemoembolization","aka":[],"tldr":"A phase 3 trial of Ethiodized oil in Hepatocellular carcinoma, run by Stanford University, recorded as terminated on the registry.","summary":"Transarterial Chemoembolization Compared With Stereotactic Body Radiation Therapy or Stereotactic Ablative Radiation Therapy in Treating Patients With Residual or Recurrent Liver Cancer Undergone Initial Transarterial Chemoembolization is a phase 3 interventional study registered as NCT02762266 by Stanford University, with 13 participants recorded, started 2016-02-27 and due to reach its primary completion in 2022-12-31. Interventions recorded: Stereotactic Body Radiation Therapy, Transarterial Chemoembolization, embolic agent, lipiodol. Conditions recorded: Child-Pugh Class A, Child-Pugh Class B, Recurrent Hepatocellular Carcinoma.\n\nLinked to the drug Ethiodized oil because the registry names it among its interventions and Hepatocellular carcinoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02762266","url":"https://clinicaltrials.gov/study/NCT02762266"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","hcc-intermediate"],"sections":[],"technologies":[],"targets":[],"drugs":["ethiodized-oil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02762266","phase":"3","setting":"International Randomized Study of Transarterial Chemoembolization (TACE) Versus Stereotactic Body Radiotherapy (SBRT) / Stereotactic Ablative Radiotherapy (SABR) for Residual or Recurrent Hepatocellular Carcinoma After Initial TACE","sponsor":"Stanford University","started":"2016-02-27","startedType":"actual","yearReported":2024,"enrolled":13,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With a Local Progression Event","primary":true,"unit":"participants","arms":[{"name":"Transarterial Chemoembolization (TACE)","n":4,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2024-03-12), not from a publication"},{"name":"Stereotactic Body Radiation Therapy (SBRT)","n":6,"value":0}],"source":"https://clinicaltrials.gov/study/NCT02762266?tab=results"}]},{"id":"nct06196788","kind":"trial","name":"Transcatheter Arterial Infusion to Patients With Advanced Pancreatic Cancer","aka":["PTCA199-9"],"tldr":"A phase 2 trial of gemcitabine and nab-paclitaxel in pancreatic cancer, run by Fudan University, now recruiting.","summary":"Transcatheter Arterial Infusion to Patients With Advanced Pancreatic Cancer is a phase 2, interventional study registered as NCT06196788 by Fudan University, with a registry enrolment figure of 30 participants, started 2024-03-01 and due to reach its primary completion in 2026-03-01. Interventions recorded: Gemcitabine; Nab paclitaxel. Conditions listed: Pancreatic Cancer. Primary outcome: Overall survival，OS. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed advanced pancreas adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06196788","url":"https://clinicaltrials.gov/study/NCT06196788"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06196788","phase":"2","setting":"Gemcitabine and Nab-paclitaxel Venous Injection Plus Transcatheter Arterial Infusion to Patients With Advanced Pancreatic Cancer","sponsor":"Fudan University","started":"2024-03-01","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"transcend","kind":"trial","name":"TRANSCEND","aka":["RM-493-040","RM-493 040","Trial 1"],"tldr":"This phase 3 trial showed that a daily injection which turns the brain's fullness signal back on cut body-mass index by about a sixth, and reduced hunger, in children and adults whose weight gain followed damage to the hypothalamus from a tumour or its treatment, while people on placebo gained weight; it supported the March 2026 US approval of Imcivree for that use.","summary":"TRANSCEND (NCT05774756; organisation id RM-493-040; US Imcivree label Trial 1) was a multicentre, double-blind, randomised, placebo-controlled phase 3 trial of setmelanotide, a melanocortin-4 receptor agonist, in acquired hypothalamic obesity. Participants were at least 4 years old with a body-mass index at or above the 95th percentile for age and sex (under 18) or at least 30 (18 and over) and a history of a hypothalamic tumour, lesion or injury. They were assigned 2:1 to setmelanotide 1.5 to 3.0 mg or placebo, injected subcutaneously once daily for 52 weeks after a dose-escalation period.\n\nThe primary endpoint was the mean percent change in body-mass index from baseline to 52 weeks after the end of dose escalation. In the NEJM 2026 report, 120 participants (81 setmelanotide, 39 placebo; mean age 19.9 years, range 4 to 66) were assigned between April 2023 and March 2025. The least-squares mean change in body-mass index was minus 16.5 percent (95 percent CI minus 19.3 to minus 13.8) with setmelanotide and plus 3.3 percent (minus 0.6 to 7.2) with placebo (P less than 0.001). Among participants aged 12 and older, the least-squares mean change in the weekly average of maximal daily hunger scores (0 to 10) was minus 2.73 versus minus 1.45 (P = 0.009). Adverse events occurred in 100 percent of the setmelanotide group and 90 percent of the placebo group, serious adverse events in 28 percent and 8 percent; skin hyperpigmentation, nausea, vomiting and headache were the commonest events with setmelanotide.\n\nThe FDA approved the acquired hypothalamic obesity indication for patients aged 4 years and older on 19 March 2026 (Drugs@FDA supplement 9). The registry lists the trial as active, not recruiting, with completion expected in 2027, and its condition is hypothalamic obesity rather than a corpus cancer, which is why the automated pass never attached it to the setmelanotide record.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05774756","url":"https://clinicaltrials.gov/study/NCT05774756"},{"label":"NEJM 2026","url":"https://doi.org/10.1056/NEJMoa2512275"},{"label":"Imcivree label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=70c3ccf7-4df0-4c75-ba07-fede9970c8d9"}],"tags":[],"related":[],"cancers":["craniopharyngioma"],"sections":["supportive-care"],"technologies":[],"targets":[],"drugs":["setmelanotide"],"companies":["rhythm-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-transcend-miller-nejm-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05774756","phase":"3","setting":"Acquired hypothalamic obesity after a hypothalamic tumour, lesion or injury in people aged 4 years and older: setmelanotide 1.5 to 3.0 mg versus placebo, injected under the skin once daily for 52 weeks after dose escalation","sponsor":"Rhythm Pharmaceuticals","result":"Least-squares mean change in body-mass index at 52 weeks minus 16.5% with setmelanotide vs plus 3.3% with placebo (P<0.001); hunger score change minus 2.73 vs minus 1.45 (P = 0.009).","started":"2023-04-26","startedType":"actual","yearReported":2026,"enrolled":120,"enrolledBasis":"analysed","enrolledNote":"The NEJM 2026 abstract reports 120 participants assigned 2:1 (81 setmelanotide, 39 placebo) in the pivotal cohort; ClinicalTrials.gov NCT05774756 lists an actual enrolment of 143 for the whole trial.","outcomes":[{"endpoint":"Mean percent change in body-mass index at 52 weeks after dose escalation (pivotal cohort)","primary":true,"unit":"%","arms":[{"name":"Setmelanotide 1.5 to 3.0 mg daily","n":81,"value":-16.5,"note":"Least-squares mean; 95% CI -19.3 to -13.8"},{"name":"Placebo","n":39,"value":3.3,"note":"Least-squares mean; 95% CI -0.6 to 7.2"}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa2512275"},{"endpoint":"Change in the weekly average of maximal daily hunger score at 52 weeks (participants aged 12 and older; scale 0 to 10)","unit":"points","arms":[{"name":"Setmelanotide 1.5 to 3.0 mg daily","value":-2.73,"note":"Least-squares mean; 95% CI -3.28 to -2.18; the abstract does not give the subgroup size"},{"name":"Placebo","value":-1.45,"note":"Least-squares mean; 95% CI -2.23 to -0.67"}],"p":"0.009","source":"https://doi.org/10.1056/NEJMoa2512275"}],"replication":"A phase 2 open-label study (Roth 2024, NCT04725240) had shown weight loss in acquired hypothalamic obesity; TRANSCEND is the first randomised confirmation. The genetic-obesity pivotals for the same drug are separate programmes."},{"id":"transcend-cll-004","kind":"trial","name":"TRANSCEND CLL 004","aka":[],"tldr":"The study that brought CAR-T to CLL: one in five heavily pretreated patients achieved complete remission, most of them lasting.","summary":"TRANSCEND CLL 004, trial NCT03331198 sponsored by Bristol Myers Squibb through Juno and published in the Lancet in 2023, is the study that brought CAR-T to chronic lymphocytic leukaemia: about one in five heavily pretreated patients achieved complete remission with lisocabtagene maraleucel, most of them lasting. In the primary analysis set of patients who had failed a BTK inhibitor and venetoclax, complete remission occurred in about a fifth, nearly half responded and most had undetectable MRD in blood, with complete responders in remission beyond two years, leading to accelerated approval on 14 March 2024. OnCo links it to chronic lymphocytic leukaemia, CAR-T, CD19 as a target and lisocabtagene maraleucel. Efficacy is lower than in lymphoma, reflecting T-cell dysfunction in CLL, and whether that can be overcome is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03331198","url":"https://clinicaltrials.gov/study/NCT03331198"}],"tags":[],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["car-t"],"targets":["cd19"],"drugs":["lisocabtagene-maraleucel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03331198","phase":"1/2","setting":"Relapsed/refractory CLL/SLL after BTK inhibitor (and venetoclax in the primary analysis set): lisocabtagene maraleucel","sponsor":"BMS / Juno","result":"CR/CRi 18-20%; ORR 47%; uMRD blood 64%.","started":"2017-11-27","startedType":"actual","yearReported":2023,"enrolled":137,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response / CRi (primary analysis set)","primary":true,"unit":"%","arms":[{"name":"Liso-cel","n":49,"value":18}],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01052-8/fulltext"},{"endpoint":"Overall response rate","unit":"%","arms":[{"name":"Liso-cel","value":47}],"source":"https://doi.org/10.1016/S0140-6736(23)01052-8"},{"endpoint":"Undetectable MRD in blood","unit":"%","arms":[{"name":"Liso-cel","value":64}],"source":"https://doi.org/10.1016/S0140-6736(23)01052-8"}],"replication":"Academic CD19 CAR-T series in CLL (Penn, Seattle) report similar CR rates and show ibrutinib co-administration improves T-cell fitness."},{"id":"transcend-nhl-001","kind":"trial","name":"TRANSCEND NHL 001","aka":["JCAR017","liso-cel pivotal study","TRANSCEND NHL 001"],"tldr":"The study that registered the third CAR-T cell product for lymphoma, built from a fixed one-to-one mix of two kinds of T cell, with fewer severe immune side effects than its predecessors.","summary":"Lisocabtagene maraleucel differs from the other two approved CD19 products in that the CD8 and CD4 chimeric antigen receptor T cells are manufactured separately and infused at equal target doses rather than as whatever ratio the patient's apheresis happened to contain. TRANSCEND NHL 001 was a seamless design study at 14 United States centres that tested three dose levels in sequence.\n\nOf 344 patients who had leukapheresis, 269 received at least one dose. They had a median of three previous lines, 42 per cent were 65 or older, 67 per cent had chemotherapy-refractory disease and seven had secondary central nervous system involvement, a group usually excluded. In the 256 patients of the efficacy-evaluable set, 186 (73 per cent, 95 per cent confidence interval 66.8 to 78.0) had an objective response and 136 (53 per cent, 46.8 to 59.4) a complete response. Safety and activity did not differ by dose level, and the recommended target dose was 100 million chimeric antigen receptor positive T cells.\n\nThe toxicity figures are why the product is used in older and frailer patients: cytokine release syndrome in 42 per cent but grade 3 or worse in only 2 per cent, neurological events in 30 per cent with 10 per cent grade 3 or worse. One patient died of diffuse alveolar damage after a dose-limiting toxicity.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT02631044","url":"https://clinicaltrials.gov/study/NCT02631044"},{"label":"Lancet 2020","url":"https://doi.org/10.1016/S0140-6736(20)31366-0"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["dlbcl","non-hodgkin-lymphoma","follicular-lymphoma","primary-mediastinal-b-cell-lymphoma"],"sections":["cell-therapy"],"technologies":["car-t"],"targets":["cd19"],"drugs":["lisocabtagene-maraleucel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["crs","icans","orr","complete-response","double-hit-lymphoma","lymphoma-tx-car-t-pathway"],"trials":["transform","zuma-1","juliet"],"people":[],"bottlenecks":["b-manufacturing-cell-therapy","b-aging-comorbidity"],"keyPapers":["paper-transcend-nhl-001-liso-cel-lancet-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02631044","phase":"1","setting":"Relapsed or refractory large B-cell lymphoma after at least one prior line, including double-hit and transformed disease: lisocabtagene maraleucel at three dose levels","sponsor":"Juno Therapeutics, a Subsidiary of Celgene","result":"Objective response in 73 per cent and complete response in 53 per cent of 256 evaluable patients, with grade 3 or worse cytokine release syndrome in 2 per cent.","started":"2016-01-06","startedType":"actual","yearReported":2020,"enrolled":269,"enrolledBasis":"treated","enrolledNote":"The registry records 387 enrolled; 344 underwent leukapheresis and 269 received at least one dose of lisocabtagene maraleucel, of whom 256 were in the efficacy-evaluable set.","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Lisocabtagene maraleucel","n":256,"value":73}],"ci":[66.8,78],"source":"https://doi.org/10.1016/S0140-6736(20)31366-0"},{"endpoint":"Complete response rate","unit":"%","arms":[{"name":"Lisocabtagene maraleucel","n":256,"value":53}],"ci":[46.8,59.4]},{"endpoint":"Grade 3 or worse cytokine release syndrome","unit":"%","arms":[{"name":"Lisocabtagene maraleucel","n":269,"value":2}]}],"replication":"Confirmed in the randomised second-line setting by TRANSFORM."},{"id":"transform","kind":"trial","name":"TRANSFORM","aka":[],"tldr":"The second trial to show a CAR-T beats transplant in early-relapsing large B-cell lymphoma.","summary":"TRANSFORM, trial NCT03575351 sponsored by Bristol Myers Squibb and reported in 2022, was the second trial to show that a CAR-T beats salvage chemotherapy and autologous transplant in primary refractory or early-relapsed large B-cell lymphoma. It randomised 184 transplant-eligible patients to lisocabtagene maraleucel or standard care, met its primary event-free survival endpoint with a large effect and a much higher complete response rate, and was the basis of liso-cel's second-line approval in June 2022, although crossover to liso-cel confounded overall survival. OnCo links it to lymphoma, CAR-T, CD19 as a target, the pairing of CAR-T before transplant at early relapse and the ZUMA-7 and TRANSFORM papers, and the result is concordant with ZUMA-7. Whether the two approved second-line CAR-Ts differ meaningfully in efficacy or toxicity is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03575351","url":"https://clinicaltrials.gov/study/NCT03575351"}],"tags":[],"related":["lymphoma-roadmap","belinda","transcend-nhl-001","lymphoma-ev-manufacturing-time-as-a-trial-endpoint"],"cancers":["dlbcl"],"sections":[],"technologies":["car-t"],"targets":["cd19"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03575351","phase":"3","setting":"Primary refractory or early-relapsed LBCL, transplant-eligible: liso-cel vs salvage + autologous transplant","sponsor":"BMS","result":"EFS HR 0.36; CR 74% vs 43%.","started":"2018-10-23","startedType":"actual","yearReported":2022,"enrolled":184,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Liso-cel","n":92,"value":29.5},{"name":"Standard care","n":92,"value":2.4}],"hr":0.36,"ci":[0.24,0.52],"source":"https://ashpublications.org/blood/article/141/14/1675/493918"}],"replication":"Concordant with ZUMA-7."},{"id":"transform-prostate","kind":"trial","name":"TRANSFORM","aka":["Trial of Randomised Approaches for National Screening FOR Men","ISRCTN13801649"],"tldr":"The trial that will decide whether Britain screens for prostate cancer, designed with the screening committee's input and built from the start to answer the question about Black men that every previous trial was too white to answer.","summary":"TRANSFORM exists because the UK National Screening Committee's March 2026 review could not answer two questions. The first is whether any modern screening pathway does more good than harm in the general population: the committee's modelling said no for PSA alone, because around 40 to 50 percent of screen-detected cancers are slow growing and at age 60 roughly half of screen-detected cases would be overdiagnosed. The second is whether it would do more good than harm in Black men, where the committee found the evidence too thin to say either way.\n\nThe trial randomises men, before consent in one of its two designs, between four screening strategies and a control group following usual care. The registry record does not enumerate the four; Prostate Cancer UK and Imperial describe them as combinations of PSA testing, a polygenic risk test and fast biparametric MRI. Stage 1 is a single screening round with a target of 16,000; stage 2 runs at least two rounds. Its eligibility rules are the point: the general invitation starts at 50, but men of Black ethnicity are invited from 45, and the design carries a floor of at least one in ten stage 1 invitations going to Black men. The government said on 2 June 2026 that it would fund the expansion so that from stage 2 all eligible Black men would be invited. The committee has said it will work with the trial team to resolve the uncertainty on Black men as soon as good data exist.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ISRCTN13801649","url":"https://www.isrctn.com/ISRCTN13801649"},{"label":"Prostate Cancer UK: the TRANSFORM trial","url":"https://prostatecanceruk.org/research/transform-trial"},{"label":"UK National Screening Committee coversheet, March 2026","url":"https://view-health-screening-recommendations.service.gov.uk/review/prostate-cancer-screening-modelling-report-2025/download-documents/cover_sheet/"}],"tags":["uk","prostate","screening"],"related":[],"cancers":["prostate","prostate-low-risk"],"sections":["early-detection"],"technologies":["mri","prostate-screening-psa-mri"],"targets":[],"drugs":[],"companies":[],"institutions":["imperial-cancer-centre","uclh","prostate-cancer-uk"],"pathways":[],"terms":["psa"],"trials":[],"people":["hashim-ahmed","rakesh-heer","ros-eeles"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN13801649","phase":"3","setting":"Men aged 50 to 74 in the general population, plus men aged 45 to 49 who are recorded in their GP list as being of Black ethnicity or who are on the learning disability quality outcomes framework register: a multi-arm multi-stage randomised platform trial comparing four prostate health checks against usual care, using two pre-consent randomisation designs, one of them a Zelen design. The ISRCTN record was assigned on 21 October 2025 and last updated on 30 December 2025; recruitment opened on 21 November 2025 and is due to close on 1 June 2027, with an overall end date of 1 December 2027","sponsor":"Imperial College Healthcare NHS Trust and University College London Hospitals NHS Foundation Trust, funded by Prostate Cancer UK and the National Institute for Health and Care Research","enrolled":16000,"enrolledBasis":"registry","outcomes":[]},{"id":"trap-btc","kind":"trial","name":"TRAP-BTC","aka":[],"tldr":"A small German study giving trastuzumab and pembrolizumab together with standard chemotherapy as the first treatment for HER2-positive bile duct or gallbladder cancer.","summary":"TRAP-BTC (NCT06178445) is a single-arm phase 2 at eight German sites for patients with histologically confirmed cholangiocarcinoma or gallbladder cancer that is HER2-positive and previously untreated, who receive standard gemcitabine and cisplatin with trastuzumab and pembrolizumab. The primary endpoint is objective response rate; 24 patients are planned, the trial opened in April 2024, is active but no longer recruiting, and lists primary completion in December 2026. It tests HER2 antibody plus checkpoint blockade on the chemotherapy backbone in a population in which gallbladder cancer is expected to predominate, ahead of the randomised HERIZON-BTC-302 and DESTINY-BTC01 trials.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06178445","url":"https://clinicaltrials.gov/study/NCT06178445"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["monoclonal-antibody","checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":["her2","pd1"],"drugs":["trastuzumab","pembrolizumab","gemcitabine-cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06178445","phase":"2","setting":"Previously untreated HER2-positive biliary tract cancer (cholangiocarcinoma or gallbladder cancer): gemcitabine and cisplatin with trastuzumab and pembrolizumab, single arm, primary endpoint objective response rate","sponsor":"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest","started":"2024-04-17","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05950945","kind":"trial","name":"Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer","aka":["DESTINY-Breast15"],"tldr":"A phase 3 trial of Trastuzumab deruxtecan in HER2-positive breast cancer and HR-positive / HER2-negative breast cancer, run by Daiichi Sankyo, now recruiting.","summary":"Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer is a phase 3 interventional study registered as NCT05950945 by Daiichi Sankyo, with 250 participants planned, started 2023-12-30 and due to reach its primary completion in 2027-10-01. Interventions recorded: Trastuzumab Deruxtecan.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05950945","url":"https://clinicaltrials.gov/study/NCT05950945"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive","breast-hr-positive","her2-low-metastatic-breast-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05950945","phase":"3","setting":"A Phase 3b, Multicenter, Global, Interventional, Open-label Study of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects Who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15)","sponsor":"Daiichi Sankyo","started":"2023-12-30","startedType":"actual","enrolled":250,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07506057","kind":"trial","name":"Trastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy","aka":["SHIELD"],"tldr":"A phase 2 trial of trastuzumab and serplulimab in gallbladder cancer and other biliary tract cancers, run by Xiujuan Qu, now recruiting.","summary":"Trastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy is a phase 2 interventional study registered as NCT07506057 by Xiujuan Qu, with a registry enrolment figure of 20 participants, started 2025-07-15 and due to reach its primary completion in 2027-07. Interventions recorded: Trastuzumab+Serplulimab. Conditions listed: Urothelial Carcinoma, Biliary Tract Cancer, HER2. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07506057","url":"https://clinicaltrials.gov/study/NCT07506057"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["monoclonal-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["trastuzumab","serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07506057","phase":"2","setting":"An Open-label, Single-arm Phase II Clinical Study of Trastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy","sponsor":"Xiujuan Qu","started":"2025-07-15","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07062263","kind":"trial","name":"Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients","aka":["TAB-2"],"tldr":"A phase 3 trial of trastuzumab in gallbladder cancer and other biliary tract cancers, run by Tata Memorial Centre, now recruiting.","summary":"Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients is a phase 3, randomised interventional study registered as NCT07062263 by Tata Memorial Centre, with a registry enrolment figure of 220 participants, started 2023-07-21 and due to reach its primary completion in 2029-07-31. Interventions recorded: Trastuzumab, Chemotherapy. Conditions listed: Biliary Tract Cancer, HER2-positive Cancer, Advanced Cancer, Unresectable Biliary Tract Carcinoma, Metastatic Biliary Tract Carcinoma. Gallbladder cancer is named in the registry entry: \"1. Biliary tract cancers include gallbladder cancer, intrahepatic cholangiocarcinoma, and perihilar cholangiocarcinoma.\". Sites: India. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07062263","url":"https://clinicaltrials.gov/study/NCT07062263"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["trastuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07062263","phase":"3","setting":"Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients - a Randomized Non-blinded Two-arm Phase III Prospective Clinical Trial (TAB-2 Study).","sponsor":"Tata Memorial Centre","started":"2023-07-21","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07129018","kind":"trial","name":"Trastuzumab Rezetecan Combined With Pertuzumab and Iparomlimab and Tuvonralimab for Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of trastuzumab rezetecan, pertuzumab and trastuzumab in gallbladder cancer and other biliary tract cancers, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, not yet recruiting.","summary":"Trastuzumab Rezetecan Combined With Pertuzumab and Iparomlimab and Tuvonralimab for Biliary Tract Cancer is a phase 2 interventional study registered as NCT07129018 by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with a registry enrolment figure of 63 participants, started 2025-11 and due to reach its primary completion in 2027-11. Interventions recorded: Trastuzumab-rezetecan + Pertuzumab + Iparomlimab and Tuvonralimab for HER2 Overexpression BTC, Trastuzumab-rezetecan + Pertuzumab + Iparomlimab and Tuvonralimab for HER2 Moderate/Low BTC. Conditions listed: Biliary Tract Cancer (BTC), First-line Therapy. Gallbladder cancer is named in the registry entry: \"3. Patients must have histologically or cytologically confirmed locally advanced or metastatic biliary tract cancer, including: Cholangiocarcinoma (intrahepatic or extrahepatic) and Gallbladder carcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07129018","url":"https://clinicaltrials.gov/study/NCT07129018"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["adc","monoclonal-antibody"],"targets":[],"drugs":["trastuzumab-rezetecan","pertuzumab","trastuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07129018","phase":"2","setting":"A Prospective, Open-Label, Multicenter Phase II Clinical Study of Trastuzumab Rezetecan Combined With Pertuzumab and Iparomlimab and Tuvonralimab as First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Biliary Tract Cancer","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","started":"2025-11","startedType":"estimated","enrolled":63,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05965531","kind":"trial","name":"Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy","aka":["TASLARC"],"tldr":"A phase 2 trial of trifluridine/tipiracil in colorectal cancer, run by Sun Yat-sen University, now recruiting.","summary":"Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy is a phase 2, interventional study registered as NCT05965531 by Sun Yat-sen University, with a registry enrolment figure of 65 participants, started 2024-01-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: Trifluridine/Tipiracil; intensity-modulated radiotherapy. Conditions listed: Rectal Cancer. Primary outcome: Objective response rate. Colorectal eligibility wording from the registry: \"* Pathologically diagnosed rectal adenocarcinoma via biopsy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05965531","url":"https://clinicaltrials.gov/study/NCT05965531"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt"],"targets":[],"drugs":["trifluridine-tipiracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05965531","phase":"2","setting":"A Single-arm, Phase II Clinical Trial to Treat Locally Advanced, pMMR Rectal Cancer With Single-agent Trifluridine/Tipiracil Chemotherapy Plus Neoadjuvant Intensity-modulated Radiotherapy","sponsor":"Sun Yat-sen University","started":"2024-01-01","startedType":"actual","enrolled":65,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04423211","kind":"trial","name":"Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging","aka":["INDICATE"],"tldr":"A phase 3 trial of Apalutamide, Degarelix, Fluciclovine F-18, Goserelin / leuprolide, Leuprolide, Relugolix and Triptorelin in Prostate cancer, run by ECOG-ACRIN Cancer Research Group, now recruiting.","summary":"Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging is a phase 3 interventional study registered as NCT04423211 by ECOG-ACRIN Cancer Research Group, with 804 participants planned, started 2020-10-08 and due to reach its primary completion in 2032-12-31. Interventions recorded: 3-Dimensional Conformal Radiation Therapy, Apalutamide, Computed Tomography, Degarelix, External Beam Radiation Therapy, Fluciclovine F18, Goserelin Acetate, Intensity-Modulated Proton Therapy, Intensity-Modulated Radiation Therapy, Leuprolide Acetate, Magnetic Resonance Imaging, Positron Emission Tomography, Quality-of-Life Assessment, Questionnaire Administration, Relugolix, Stereotactic Body Radiation Therapy, Triptorelin, Volume Modulated Arc Therapy. Conditions recorded: Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8.\n\nLinked to the drug Fluciclovine F-18 because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04423211","url":"https://clinicaltrials.gov/study/NCT04423211"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-bcr"],"sections":[],"technologies":[],"targets":[],"drugs":["apalutamide","degarelix","fluciclovine-f18","goserelin","leuprolide","relugolix","triptorelin"],"companies":["ecog-acrin"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04423211","phase":"3","setting":"Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)","sponsor":"ECOG-ACRIN Cancer Research Group","started":"2020-10-08","startedType":"actual","enrolled":804,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04960709","kind":"trial","name":"Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin","aka":["VOLGA"],"tldr":"A phase 3 trial of Durvalumab, Tremelimumab and Enfortumab vedotin in bladder & urothelial cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin is a phase 3 interventional study registered as NCT04960709 by AstraZeneca, with 712 participants enrolled, started 2021-08-05 and due to reach its primary completion in 2026-03-02. Interventions recorded: Durvalumab, Tremelimumab, Enfortumab Vedotin and Radical Cystectomy.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04960709","url":"https://clinicaltrials.gov/study/NCT04960709"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc","checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab","enfortumab-vedotin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04960709","phase":"3","setting":"A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)","sponsor":"AstraZeneca","started":"2021-08-05","startedType":"actual","enrolled":712,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05451784","kind":"trial","name":"Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ TILS","aka":["TILS001"],"tldr":"A phase 1/2 trial in triple-negative breast cancer, run by Fundacio Clinic Barcelona, now recruiting.","summary":"Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ TILS is a phase 1/2, interventional study registered as NCT05451784 by Fundacio Clinic Barcelona, with a registry enrolment figure of 20 participants, started 2022-07-20 and due to reach its primary completion in 2025-11-30. Interventions recorded: PD1+ TILs (NUMARZU-001) product infusion. Conditions listed: Metastatic Triple-Negative Breast Carcinoma. Triple-negative eligibility wording from the registry: \"Histologically confirmed diagnosis of advanced triple-negative breast cancer (based on the most recently analyzed biopsy from locally recurrent or metastatic site, local laboratory) meeting the following criteria: HER2-negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 \". Sites: Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05451784","url":"https://clinicaltrials.gov/study/NCT05451784"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05451784","phase":"1/2","setting":"Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ Tumor-infiltrating Lymphocytes (TILS001 Trial)","sponsor":"Fundacio Clinic Barcelona","started":"2022-07-20","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04514419","kind":"trial","name":"Treatment of Breast Cancer With Trastuzumab + HS627/ Pertuzumab + Docetaxel","aka":[],"tldr":"A phase 3 trial of Pertuzumab in advanced solid tumours, run by BioRay Pharmaceutical Co., Ltd., active and no longer recruiting.","summary":"Treatment of Breast Cancer With Trastuzumab + HS627/ Pertuzumab + Docetaxel is a phase 3 interventional study registered as NCT04514419 by BioRay Pharmaceutical Co., Ltd., with 408 participants enrolled, started 2020-06-28 and due to reach its primary completion in 2024-09-11. Interventions recorded: HS627 and Pertuzumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04514419","url":"https://clinicaltrials.gov/study/NCT04514419"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["pertuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04514419","phase":"3","setting":"A Phase III Study to Compare HS627 vs. Pertuzumab on the Efficacy, Safety and Immunogenicity in Combination With Trastuzumab and Docetaxel as Neoadjuvant Therapy in Patients With Early-stage or Locally Advanced HER2 Positive Breast Cancer","sponsor":"BioRay Pharmaceutical Co., Ltd.","started":"2020-06-28","startedType":"actual","enrolled":408,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05294731","kind":"trial","name":"Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader","aka":[],"tldr":"A phase 1/2 trial of BGB-16673 in hodgkin lymphoma and non-hodgkin lymphoma, run by BeiGene, now recruiting.","summary":"Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader is a phase 1/2 interventional study registered as NCT05294731 by BeiGene, with 146 participants planned, started 2022-05-06 and due to reach its primary completion in 2029-01-31. Interventions recorded: BGB-16673. Conditions listed: B-cell Malignancy, Non-Hodgkin Lymphoma, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05294731","url":"https://clinicaltrials.gov/study/NCT05294731"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hodgkin-lymphoma","non-hodgkin-lymphoma","mantle-cell-lymphoma","follicular-lymphoma"],"sections":[],"technologies":["protac-degrader"],"targets":[],"drugs":["bgb-16673"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05294731","phase":"1/2","setting":"A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Chinese Patients With B-Cell Malignancies","sponsor":"BeiGene","started":"2022-05-06","startedType":"actual","enrolled":146,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00199043","kind":"trial","name":"Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma","aka":[],"tldr":"A phase 3 trial of Rasburicase in Leukaemia, run by Goethe University, completed.","summary":"Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma is a phase 3 interventional study registered as NCT00199043 by Goethe University, with 80 participants recorded, started 2003-05 and reaching its primary completion in 2008-05. Interventions recorded: Allopurinol, Rasburicase. Conditions recorded: Adult Acute Lymphocytic Leukemia, High-grade Lymphoma.\n\nLinked to the drug Rasburicase because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00199043","url":"https://clinicaltrials.gov/study/NCT00199043"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["rasburicase"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00199043","phase":"3","setting":"Randomised Phase III Trial of Effectivity and Safety of Rasburicase Compared With Allopurinol for Treatment of Hyperuricemia in Patients With Acute Lymphoblastic Leukemia or High-Grade NHL With High Risk of Tumorlysis Syndrome (> 15 Yrs)","sponsor":"Goethe University","started":"2003-05","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06432296","kind":"trial","name":"Treatment of Malignant Ascites Caused by Advanced Epithelial Solid Tumors With M701 Bispecific Antibody","aka":[],"tldr":"A phase 3 trial of M701 run by Wuhan YZY Biopharma Co., Ltd., active.","summary":"Treatment of Malignant Ascites Caused by Advanced Epithelial Solid Tumors With M701 Bispecific Antibody is a phase 3 interventional study registered as NCT06432296 by Wuhan YZY Biopharma Co., Ltd., with 312 participants enrolled, started 2024-03-25. Conditions listed: Malignant Ascites. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06432296","url":"https://clinicaltrials.gov/study/NCT06432296"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["bispecific-antibody","t-cell-engager"],"targets":[],"drugs":["m701"],"companies":["wuhan-yzy-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06432296","phase":"3","setting":"A Randomized, Controlled, Multi-Center Phase III Clinical Study to Evaluate the Efficacy and Safety of M701 for Intraperitoneal Injection in Patients With Malignant Ascites Caused by Advanced Epithelial Solid Tumors","sponsor":"Wuhan YZY Biopharma Co., Ltd.","started":"2024-03-25","startedType":"actual","enrolled":312,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07188441","kind":"trial","name":"Treatment of Newly Diagnosed Central Malignant Germ Cell Tumor People With Teniposide Injection Combined With Cisplatin","aka":[],"tldr":"A phase 2 trial of Teniposide and Cisplatin in Germ cell tumours of childhood and adolescence, run by Chengcheng Guo, now recruiting.","summary":"Treatment of Newly Diagnosed Central Malignant Germ Cell Tumor People With Teniposide Injection Combined With Cisplatin is a phase 2 interventional study registered as NCT07188441 by Chengcheng Guo, with 40 participants planned, started 2024-08-13 and due to reach its primary completion in 2026-12. Interventions recorded: Teniposide Injection. Conditions recorded: GCT, Germ Cell Tumor, Central Malignant Germ Cell Tumor.\n\nLinked to the drug Teniposide because the registry names it among its interventions and Germ cell tumours of childhood and adolescence among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07188441","url":"https://clinicaltrials.gov/study/NCT07188441"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["paediatric-germ-cell-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["teniposide","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07188441","phase":"2","setting":"A Single-center, Single-arm, Open-label Study of the Combination of Teniposide Injection and Cisplatin in the Treatment of Newly Diagnosed Patients With Central Malignant Germ Cell Tumors.","sponsor":"Chengcheng Guo","started":"2024-08-13","startedType":"actual","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00136084","kind":"trial","name":"Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia","aka":[],"tldr":"A phase 3 trial of Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone, Etoposide, Mitoxantrone, Prednisone and Vincristine in Leukaemia, run by St. Jude Children's Research Hospital, completed.","summary":"Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia is a phase 3 interventional study registered as NCT00136084 by St. Jude Children's Research Hospital, with 238 participants recorded, started 2002-08 and reaching its primary completion in 2008-07. Interventions recorded: Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone, Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine. Conditions recorded: Leukemia, Myelocytic, Acute.\n\nLinked to the drug Cladribine because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00136084","url":"https://clinicaltrials.gov/study/NCT00136084"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["cladribine","cyclophosphamide","cytarabine","daunorubicin","dexamethasone","etoposide","mitoxantrone","prednisone","vincristine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00136084","phase":"3","setting":"A Collaborative Trial for the Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia","sponsor":"St. Jude Children's Research Hospital","started":"2002-08","enrolled":238,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06011109","kind":"trial","name":"Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab","aka":[],"tldr":"A phase 1/2 trial of APG-157 in glioma & glioblastoma, run by Aveta Biomics, Inc., now recruiting.","summary":"Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab is a phase 1/2 interventional study registered as NCT06011109 by Aveta Biomics, Inc., with 30 participants planned, started 2023-12-13 and due to reach its primary completion in 2026-12-31. Interventions recorded: APG-157.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06011109","url":"https://clinicaltrials.gov/study/NCT06011109"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["aveta-biomics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06011109","phase":"1/2","setting":"A Pilot Study of APG-157 With Bevacizumab for Patients With Recurrent High-Grade Glioma","sponsor":"Aveta Biomics, Inc.","started":"2023-12-13","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06304545","kind":"trial","name":"Treatment of Rectal Cancer With Long-term Concurrent Chemoradiotherapy Combined With Camrelizumab","aka":[],"tldr":"A phase 2 trial of camrelizumab in colorectal cancer, run by Harbin Medical University, not yet recruiting.","summary":"Treatment of Rectal Cancer With Long-term Concurrent Chemoradiotherapy Combined With Camrelizumab is a phase 2, interventional study registered as NCT06304545 by Harbin Medical University, with a registry enrolment figure of 48 participants, started 2024-03-15 and due to reach its primary completion in 2026-08-16. Interventions recorded: Camrelizumab; Chemotherapy; Radiotherapy. Conditions listed: Rectal Cancer. Primary outcome: Pathological Complete Response rate. Colorectal eligibility wording from the registry: \"Histologically or cytologically confirmed rectal cancer with measurable tumour lesions (Spiral CT or MR scans ≥ 10 mm, meeting RECIST 1\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06304545","url":"https://clinicaltrials.gov/study/NCT06304545"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["camrelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06304545","phase":"2","setting":"Long-course Concurrent Chemoradiotherapy Combined With Camrelizumab in the Neoadjuvant Treatment of Locally Advanced/Low Anus-preserving Rectal Cancer: a Phase II Single-arm Study.","sponsor":"Harbin Medical University","started":"2024-03-15","startedType":"estimated","enrolled":48,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03367572","kind":"trial","name":"Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer","aka":[],"tldr":"A phase 3 trial of Dexamethasone, Palonosetron and Netupitant and palonosetron in Breast cancer, run by University of Rochester NCORP Research Base, completed.","summary":"Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer is a phase 3 interventional study registered as NCT03367572 by University of Rochester NCORP Research Base, with 1363 participants recorded, started 2018-04-19 and reaching its primary completion in 2024-04-13. Interventions recorded: Dexamethasone, Laboratory Biomarker Analysis, Netupitant/Palonosetron Hydrochloride, Olanzapine, Placebo, Prochlorperazine, Quality-of-Life Assessment. Conditions recorded: Breast Carcinoma.\n\nLinked to the drug Netupitant and palonosetron because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03367572","url":"https://clinicaltrials.gov/study/NCT03367572"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["dexamethasone","palonosetron","netupitant-palonosetron"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03367572","phase":"3","setting":"Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer","sponsor":"University of Rochester NCORP Research Base","started":"2018-04-19","startedType":"actual","enrolled":1363,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04137653","kind":"trial","name":"Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective RCT","aka":[],"tldr":"A phase 3 trial of nab-paclitaxel, carboplatin and paclitaxel / nab-paclitaxel in triple-negative breast cancer, run by Shengjing Hospital, now recruiting.","summary":"Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective RCT is a phase 3, randomised interventional study registered as NCT04137653 by Shengjing Hospital, with a registry enrolment figure of 1498 participants, started 2021-07-19 and due to reach its primary completion in 2025-11-30. Interventions recorded: nab-Paclitaxel+carboplatin; Paclitaxel+carboplatin. Conditions listed: Breast Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04137653","url":"https://clinicaltrials.gov/study/NCT04137653"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["nab-paclitaxel","carboplatin","paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04137653","phase":"3","setting":"Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective Randomized Controlled Clinical Trial","sponsor":"Shengjing Hospital","started":"2021-07-19","startedType":"estimated","enrolled":1498,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03206671","kind":"trial","name":"Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents","aka":[],"tldr":"A phase 3 trial of Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin, Vindesine, Etoposide, Ifosfamide, Methotrexate, Prednisone and Vincristine in Non-Hodgkin lymphoma, run by University Hospital Muenster, active and no longer recruiting.","summary":"Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents is a phase 3 interventional study registered as NCT03206671 by University Hospital Muenster, with 650 participants planned, started 2017-08-03 and due to reach its primary completion in 2027-06. Interventions recorded: Rituximab window, Additional doses of Rituximab, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Vindesine Sulfate, Etoposide, Ifosfamide, Methotrexate, Prednisolone, Vincristine. Conditions recorded: Mature B-cell Non-Hodgkin Lymphoma.\n\nLinked to the drug Vindesine because the registry names it among its interventions and Non-Hodgkin lymphoma among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03206671","url":"https://clinicaltrials.gov/study/NCT03206671"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["cyclophosphamide","cytarabine","dexamethasone","doxorubicin","vindesine","etoposide","ifosfamide","methotrexate","prednisone","vincristine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03206671","phase":"3","setting":"B-NHL 2013 - Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents","sponsor":"University Hospital Muenster","started":"2017-08-03","startedType":"actual","enrolled":650,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01594879","kind":"trial","name":"Treatment With Medroxyprogesterone Acetate Plus LNG-IUS in Young Women With Early Stage Endometrial Cancer","aka":[],"tldr":"A phase 2 trial of Progestins in Endometrial cancer, run by Korean Gynecologic Oncology Group, with a status the registry has not verified recently.","summary":"Treatment With Medroxyprogesterone Acetate Plus LNG-IUS in Young Women With Early Stage Endometrial Cancer is a phase 2 interventional study registered as NCT01594879 by Korean Gynecologic Oncology Group, with 39 participants planned, started 2012-01 and due to reach its primary completion in 2014-12. Interventions recorded: MIrena(LNG-IUS), oral MPA. Conditions recorded: Endometrial Cancer.\n\nLinked to the drug Progestins because the registry names it among its interventions and Endometrial cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01594879","url":"https://clinicaltrials.gov/study/NCT01594879"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial"],"sections":[],"technologies":[],"targets":[],"drugs":["megestrol-progestins"],"companies":["kgog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01594879","phase":"2","setting":"Treatment With Medroxyprogesterone Acetate(MPA) Plus Levonorgestrel-releasing Intrauterine System(LNG-IUS) in Young Women With Early Stage Endometrial Cancer: Multicenter Study: Korean Gynecologic Oncology Group Study (KGOG2009)","sponsor":"Korean Gynecologic Oncology Group","started":"2012-01","enrolled":39,"enrolledBasis":"registry","outcomes":[]},{"id":"treetopp","kind":"trial","name":"TreeTopp","aka":[],"tldr":"TreeTopp tested whether the HER-family blocker varlitinib added to capecitabine helps bile duct and gallbladder cancer after first-line chemotherapy. It did not: response, progression and survival were the same, and the planned phase 3 part was abandoned. A small gallbladder subgroup hinted at slower progression but the finding was not conclusive.","summary":"TreeTopp (NCT03093870) was a global, double-blind, randomised, placebo-controlled phase 2 (part 1 of a planned phase 2/3) in patients with unresectable or metastatic biliary tract cancer, including gallbladder and ampullary cancer, after one prior gemcitabine-containing line. Patients received varlitinib 300 mg or placebo twice daily with capecitabine 1,000 mg/m² twice daily on days 1 to 14 of 21-day cycles. Of 127 treated patients (64 varlitinib, 63 placebo), objective response by independent central review was 9.4 versus 4.8 percent (odds ratio 2.28, p 0.42), median progression-free survival 2.83 versus 2.79 months (hazard ratio 0.90, 95 percent confidence interval 0.60 to 1.37) and overall survival 7.8 versus 7.5 months (hazard ratio 1.11, 0.69 to 1.79). Grade 3 or worse treatment-emergent adverse events occurred in 65.6 versus 58.7 percent. In subgroup analysis varlitinib appeared to prolong progression-free survival in women (4.1 versus 2.8 months, hazard ratio 0.59) and in gallbladder cancer (2.9 versus 1.6 months, hazard ratio 0.55, 0.26 to 1.19). The trial ended varlitinib development in biliary cancer and is the clearest failure of unselected pan-HER inhibition in the disease, in contrast to HER2-selected antibody therapy.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03093870","url":"https://clinicaltrials.gov/study/NCT03093870"},{"label":"Javle et al., ESMO Open 2022: TreeTopp","url":"https://doi.org/10.1016/j.esmoop.2021.100314"}],"tags":["failure"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["kinase-inhibitors","cytotoxic-chemotherapy"],"targets":["her2","egfr"],"drugs":["varlitinib","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03093870","phase":"2/3","setting":"Second-line advanced biliary tract cancer after one gemcitabine-containing line: capecitabine with varlitinib or placebo, double-blind randomised (part 1 of a planned phase 2/3)","sponsor":"ASLAN Pharmaceuticals","result":"ORR 9.4% vs 4.8%; PFS 2.83 vs 2.79 months, HR 0.90; OS 7.8 vs 7.5 months, HR 1.11; gallbladder subgroup PFS 2.9 vs 1.6 months, HR 0.55 (0.26 to 1.19).","started":"2017-07-04","startedType":"actual","yearReported":2022,"enrolled":151,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (independent central review)","primary":true,"unit":"%","arms":[{"name":"Varlitinib + capecitabine","n":64,"value":9.4},{"name":"Placebo + capecitabine","n":63,"value":4.8}],"p":"0.42","source":"https://doi.org/10.1016/j.esmoop.2021.100314"},{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Varlitinib + capecitabine","n":64,"value":2.83},{"name":"Placebo + capecitabine","n":63,"value":2.79}],"hr":0.9,"ci":[0.6,1.37],"p":"0.63","source":"https://doi.org/10.1016/j.esmoop.2021.100314"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Varlitinib + capecitabine","n":64,"value":7.8},{"name":"Placebo + capecitabine","n":63,"value":7.5}],"hr":1.11,"ci":[0.69,1.79],"p":"0.66","source":"https://doi.org/10.1016/j.esmoop.2021.100314"},{"endpoint":"Progression-free survival, gallbladder cancer subgroup","unit":"months","arms":[{"name":"Varlitinib + capecitabine","value":2.9},{"name":"Placebo + capecitabine","value":1.6}],"hr":0.55,"ci":[0.26,1.19],"source":"https://doi.org/10.1016/j.esmoop.2021.100314"}]},{"id":"nct07271992","kind":"trial","name":"TREND-02 - a Phase II Exploratory De-escalation Trial of Neoadjuvant Sacituzumab Govitecan Plus Tislelizumab (SG/I) in Early Triple-negative Breast Cancer","aka":["TREND-02"],"tldr":"A phase 2 trial of sacituzumab govitecan in triple-negative breast cancer, run by First Hospital of China Medical University, not yet recruiting.","summary":"TREND-02 - a Phase II Exploratory De-escalation Trial of Neoadjuvant Sacituzumab Govitecan Plus Tislelizumab (SG/I) in Early Triple-negative Breast Cancer is a phase 2, interventional study registered as NCT07271992 by First Hospital of China Medical University, with a registry enrolment figure of 30 participants, started 2025-12-15 and due to reach its primary completion in 2030-12-14. Interventions recorded: SG+I. Conditions listed: TNBC, Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Histologically confirmed stage II or III primary invasive TNBC TNBC defined as: immunohistochemistry (IHC) ER and PR \\<1%; HER2-negative, IHC 0 or 1+, IHC 2+, ISH-; 3\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07271992","url":"https://clinicaltrials.gov/study/NCT07271992"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07271992","phase":"2","setting":"TREND-02 - a Phase II Exploratory De-escalation Trial of Neoadjuvant Sacituzumab Govitecan Plus Tislelizumab (SG/I) in Early Triple-negative Breast Cancer","sponsor":"First Hospital of China Medical University","started":"2025-12-15","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00168181","kind":"trial","name":"Trial Comparing Oral Pilocarpine (Salagen) Versus Submandibular Salivary Gland Transfer Protocol, For the Prevention of Radiation (XRT) Induced Xerostomia in Head and Neck Cancer Patients","aka":[],"tldr":"A phase 3 trial of Pilocarpine in Head and neck squamous cell carcinoma, run by Alberta Health services, completed.","summary":"Trial Comparing Oral Pilocarpine (Salagen) Versus Submandibular Salivary Gland Transfer Protocol, For the Prevention of Radiation (XRT) Induced Xerostomia in Head and Neck Cancer Patients is a phase 3 interventional study registered as NCT00168181 by Alberta Health services, with 220 participants recorded, started 2002-04. Interventions recorded: Submandibular gland Transfer, Salagen. Conditions recorded: Cancer, Head and Neck Cancer.\n\nLinked to the drug Pilocarpine because the registry names it among its interventions and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00168181","url":"https://clinicaltrials.gov/study/NCT00168181"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":["pilocarpine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00168181","phase":"3","setting":"A Phase III Randomized Trial Comparing Oral Pilocarpine (Salagen) Versus Submandibular Salivary Gland Transfer Protocol, For the Prevention of Radiation (XRT) Induced Xerostomia in Head and Neck Cancer Patients","sponsor":"Alberta Health services","started":"2002-04","enrolled":220,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07282912","kind":"trial","name":"Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","aka":["OLIGOMETS"],"tldr":"A phase 2 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by Yale University, now recruiting.","summary":"Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels is a phase 2, randomised interventional study registered as NCT07282912 by Yale University, with a registry enrolment figure of 54 participants, started 2026-06-02 and due to reach its primary completion in 2028-06. Interventions recorded: Sequential cytoreductive intervention, Signatera Genome ultra-sensitive ctDNA blood test. Conditions listed: Foregut Adenocarcinoma, Esophageal Adenocarcinoma, Gastroesophageal Adenocarcinoma, Gastric Adenocarcinoma, Pancreas Adenocarcinoma, Duodenal Adenocarcinoma, Ampullary Adenocarcinoma, Gallbladder Adenocarcinoma, Intra - and Extrahepatic Cholangiocarcinoma. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07282912","url":"https://clinicaltrials.gov/study/NCT07282912"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","ampullary"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["ctdna"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07282912","phase":"2","setting":"Phase II Prospective, Open Label Randomized Controlled Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","sponsor":"Yale University","started":"2026-06-02","startedType":"actual","enrolled":54,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05988814","kind":"trial","name":"Trial Evaluating the Efficacy and the Safety of FOLFIRINOX3 Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer in First Li","aka":["FOLFIRINOX3 P"],"tldr":"A phase 2 trial in pancreatic cancer, run by Centre Georges Francois Leclerc, now recruiting.","summary":"Trial Evaluating the Efficacy and the Safety of FOLFIRINOX3 Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer in First Line of Chemotherapy is a phase 2, interventional study registered as NCT05988814 by Centre Georges Francois Leclerc, with a registry enrolment figure of 90 participants, started 2024-01-24 and due to reach its primary completion in 2029-07-24. Interventions recorded: FOLFIRINOX treatment. Conditions listed: Metastatic Pancreatic Cancer. Primary outcome: Progression-free survival (PFS). Pancreatic eligibility wording from the registry: \"* Patients with pancreatic adenocarcinoma\". Sites: France. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05988814","url":"https://clinicaltrials.gov/study/NCT05988814"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05988814","phase":"2","setting":"Phase II Trial Evaluating the Efficacy and the Safety of FOLFIRINOX3 Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer in First Line of Chemotherapy (FOLFIRINOX3 Pancréas)","sponsor":"Centre Georges Francois Leclerc","started":"2024-01-24","startedType":"actual","enrolled":90,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04875585","kind":"trial","name":"Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC","aka":["INNWOP1"],"tldr":"A phase 2 trial of pembrolizumab and lenvatinib in lung cancer, run by Medical University Innsbruck, now recruiting.","summary":"Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC is a phase 2, interventional study registered as NCT04875585 by Medical University Innsbruck, with a registry enrolment figure of 33 participants, started 2021-05-12 and due to reach its primary completion in 2023-12. Interventions recorded: neoadjuvant therapy with Pembrolizumab/Lenvatinib; Surgery; Adjuvant Treatment Phase. Conditions listed: Non Small Cell Lung Cancer. Primary outcome: Major pathological response after neoadjuvant immunotherapy in combination with angiogenesis inhibition. Lung eligibility wording from the registry: \"Histologically confirmed primary diagnosis of resectable NSCLC, stages IA3-IIIA (max\". Sites: Austria. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04875585","url":"https://clinicaltrials.gov/study/NCT04875585"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["pembrolizumab","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04875585","phase":"2","setting":"Phase II Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib and Adjuvant Pembrolizumab in Patients With Surgically Resectable Non-Small- Cell Lung Cancer (NSCLC)","sponsor":"Medical University Innsbruck","started":"2021-05-12","startedType":"actual","enrolled":33,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06371807","kind":"trial","name":"Trial for Treatment of High Risk BC With Two Sequences of Neoadjuvant Chemotherapy With Pembrolizumab","aka":["KEYPARTNER"],"tldr":"A phase 2 trial of pembrolizumab in triple-negative breast cancer, run by Fundacao Champalimaud, not yet recruiting.","summary":"Trial for Treatment of High Risk BC With Two Sequences of Neoadjuvant Chemotherapy With Pembrolizumab is a phase 2, randomised interventional study registered as NCT06371807 by Fundacao Champalimaud, with a registry enrolment figure of 20 participants, started 2024-07 and due to reach its primary completion in 2025-07. Interventions recorded: Pembrolizumab injection. Conditions listed: Early Breast Cancer; Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Have locally histologically confirmed diagnosis of invasive carcinoma of the breast that is classified as TNBC, as defined by the most recent ASCO/CAP guidelines\". Sites: Portugal. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06371807","url":"https://clinicaltrials.gov/study/NCT06371807"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06371807","phase":"2","setting":"Immunogenicity Profile of Neoadjuvant Keytruda in Combination With Anthracycline Versus Carboplatin/PAclitaxel Containing Chemotherapy Regimen for The Treatment of Early-stage, TILs-Positive, Triple-Negative Breast CanceR","sponsor":"Fundacao Champalimaud","started":"2024-07","startedType":"estimated","enrolled":20,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07246863","kind":"trial","name":"Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC","aka":["GDFATHER-NSCLC-02"],"tldr":"A phase 2 trial of Visugromab, Nivolumab, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by CatalYm GmbH, now recruiting.","summary":"Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC is a phase 2 interventional study registered as NCT07246863 by CatalYm GmbH, with 131 participants planned, started 2025-10-07 and due to reach its primary completion in 2029-10-01. Interventions recorded: Visugromab RDE (recommended dose for expansion), Visugromab 6mg/kg, Nivolumab, Placebo Saline Infusion, Docetaxel. Conditions listed: Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07246863","url":"https://clinicaltrials.gov/study/NCT07246863"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["visugromab","nivolumab","docetaxel"],"companies":["catalym"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07246863","phase":"2","setting":"Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)","sponsor":"CatalYm GmbH","started":"2025-10-07","startedType":"actual","enrolled":131,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07098988","kind":"trial","name":"Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC","aka":["GDFATHER-NSCLC-01"],"tldr":"A phase 2 trial of Visugromab, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by CatalYm GmbH, now recruiting.","summary":"Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC is a phase 2 interventional study registered as NCT07098988 by CatalYm GmbH, with 107 participants planned, started 2025-08-01 and due to reach its primary completion in 2029-03-31. Interventions recorded: Visugromab, Matching placebo for visugromab, Pembrolizumab 200 mg Q3W, Pemetrexed 500 mg/m^2, Carboplatin AUC 5. Conditions listed: Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07098988","url":"https://clinicaltrials.gov/study/NCT07098988"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["visugromab","pembrolizumab"],"companies":["catalym"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07098988","phase":"2","setting":"A Ph2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo, in Combination With Pembrolizumab, Pemetrexed, and Carboplatin, in 1L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-01)","sponsor":"CatalYm GmbH","started":"2025-08-01","startedType":"actual","enrolled":107,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06590857","kind":"trial","name":"Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.","aka":["TRACY-1"],"tldr":"A phase 1/2 trial of Actinium-225 DOTATATE in HR-positive / HER2-negative breast cancer, run by RayzeBio, Inc., active and no longer recruiting.","summary":"Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs. is a phase 1/2 interventional study registered as NCT06590857 by RayzeBio, Inc., with 16 participants enrolled, started 2024-07-19 and due to reach its primary completion in 2028-10. Interventions recorded: RYZ101 and Standard of Care Endocrine Therapy.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06590857","url":"https://clinicaltrials.gov/study/NCT06590857"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["targeted-alpha-therapy"],"targets":[],"drugs":["ryz101"],"companies":["rayzebio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06590857","phase":"1/2","setting":"Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) in Subjects With Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) (TRACY-1).","sponsor":"RayzeBio, Inc.","started":"2024-07-19","startedType":"actual","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07042685","kind":"trial","name":"Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by The Methodist Hospital Research Institute, now recruiting.","summary":"Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer is a phase 2, interventional study registered as NCT07042685 by The Methodist Hospital Research Institute, with a registry enrolment figure of 50 participants, started 2026-01-27 and due to reach its primary completion in 2028-12. Interventions recorded: Fruquintinib Combined With Chemotherapy. Conditions listed: Metastatic Colorectal Cancer (CRC). Primary outcome: Time to Progression of 5FU in combination with fruquintinib in first-line metastatic colorectal cancer patients. Colorectal eligibility wording from the registry: \"Histopathologically or cytologically confirmed locally advanced unresectable or metastatic colorectal cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07042685","url":"https://clinicaltrials.gov/study/NCT07042685"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07042685","phase":"2","setting":"Phase II Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib as First Line in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer","sponsor":"The Methodist Hospital Research Institute","started":"2026-01-27","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06617858","kind":"trial","name":"Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment is a phase 2, interventional study registered as NCT06617858 by M.D. Anderson Cancer Center, with a registry enrolment figure of 15 participants, started 2024-12-04 and due to reach its primary completion in 2028-02-01. Interventions recorded: AMB-05X. Conditions listed: Colorectal Cancer. Primary outcome: Safety and Adverse Events (AEs). Colorectal eligibility wording from the registry: \"Histologic or pathologic confirmation of adenocarcinoma of the colon or rectum\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06617858","url":"https://clinicaltrials.gov/study/NCT06617858"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06617858","phase":"2","setting":"Open-label Phase 2 Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment","sponsor":"M.D. Anderson Cancer Center","started":"2024-12-04","startedType":"actual","enrolled":15,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07689539","kind":"trial","name":"Trial of DN022150 Versus Chemotherapy in Previously Treated Advanced Pancreatic Cancer With KRAS G12D Mutation","aka":[],"tldr":"A phase 3 trial in pancreatic cancer, run by Jiangxi Kvvit Pharmaceutical Co., Ltd., not yet recruiting.","summary":"Trial of DN022150 Versus Chemotherapy in Previously Treated Advanced Pancreatic Cancer With KRAS G12D Mutation is a phase 3, randomised interventional study registered as NCT07689539 by Jiangxi Kvvit Pharmaceutical Co., Ltd., with a registry enrolment figure of 360 participants, started 2026-09 and due to reach its primary completion in 2028-07. Interventions recorded: DN022150; Chemotherapy. Conditions listed: Pancreatic Cancer. Primary outcome: Progression-Free Survival (PFS); Overall Survival (OS). Pancreatic eligibility wording from the registry: \"Subjects with confirmed KRAS G12D who have received prior systemic therapy for advanced or metastatic pancreatic cancer\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07689539","url":"https://clinicaltrials.gov/study/NCT07689539"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07689539","phase":"3","setting":"A Phase 3, Multicenter, Open-Label, Randomized, Controlled Trial of DN022150 Monotherapy Versus Investigator's Choice Chemotherapy in Previously Treated Advanced Pancreatic Cancer With KRAS G12D Mutation","sponsor":"Jiangxi Kvvit Pharmaceutical Co., Ltd.","started":"2026-09","startedType":"estimated","enrolled":360,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06860685","kind":"trial","name":"Trial of Gum Chewing to Enhance the Restoration of Intestinal Motility in Colorectal Cancer Surgery","aka":[],"tldr":"A phase 1/2 trial in colorectal cancer, run by Sichuan Cancer Hospital and Research Institute, not yet recruiting.","summary":"Trial of Gum Chewing to Enhance the Restoration of Intestinal Motility in Colorectal Cancer Surgery is a phase 1/2, interventional study registered as NCT06860685 by Sichuan Cancer Hospital and Research Institute, with a registry enrolment figure of 292 participants, started 2025-03-01 and due to reach its primary completion in 2025-07-31. Interventions recorded: gum chewing. Conditions listed: Colorectal Cancer (CRC). Primary outcome: first flatus time; first defecation time; proportion of delayed restoration of intestinal motility. Colorectal eligibility wording from the registry: \"* Patients with newly diagnosed colorectal cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06860685","url":"https://clinicaltrials.gov/study/NCT06860685"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06860685","phase":"1/2","setting":"A Non-randomised External Controlled Trial of Gum Chewing to Enhance the Restoration of Intestinal Motility in Colorectal Surgery","sponsor":"Sichuan Cancer Hospital and Research Institute","started":"2025-03-01","startedType":"estimated","enrolled":292,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03379428","kind":"trial","name":"Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer","aka":[],"tldr":"A phase 1/2 trial of Trastuzumab and Ibrutinib in advanced solid tumours, run by US Oncology Research, active and no longer recruiting.","summary":"Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer is a phase 1/2 interventional study registered as NCT03379428 by US Oncology Research, with 34 participants enrolled, started 2017-11-29 and due to reach its primary completion in 2025-01. Interventions recorded: Trastuzumab, Ibrutinib 560 mg, Ibrutinib 840 mg and Ibrutinib 420 mg.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03379428","url":"https://clinicaltrials.gov/study/NCT03379428"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["trastuzumab","ibrutinib"],"companies":["mckesson-us-oncology","abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03379428","phase":"1/2","setting":"Phase I/II Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer","sponsor":"US Oncology Research","started":"2017-11-29","startedType":"actual","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00671918","kind":"trial","name":"Trial of Lymphoseek in Intraoperative Localization of Lymph Nodes in Breast Cancer and Melanoma","aka":[],"tldr":"A phase 3 trial of Technetium-99m tilmanocept in Breast cancer and Melanoma, run by Navidea Biopharmaceuticals, completed.","summary":"Trial of Lymphoseek in Intraoperative Localization of Lymph Nodes in Breast Cancer and Melanoma is a phase 3 interventional study registered as NCT00671918 by Navidea Biopharmaceuticals, with 186 participants recorded, started 2008-04 and reaching its primary completion in 2009-06. Interventions recorded: Lymphoseek. Conditions recorded: Breast Cancer, Melanoma.\n\nLinked to the drug Technetium-99m tilmanocept because the registry names it among its interventions and Breast cancer and Melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00671918","url":"https://clinicaltrials.gov/study/NCT00671918"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer","melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["tilmanocept-tc99m"],"companies":["navidea"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00671918","phase":"3","setting":"A Phase 3, Prospective, Open-Label, Multicenter Comparison Study of Lymphoseek® and Vital Blue Dye as Lymphoid Tissue Targeting Agents in Patients With Known Melanoma or Breast Cancer Who Are Undergoing Lymph Node Mapping","sponsor":"Navidea Biopharmaceuticals","started":"2008-04","yearReported":2013,"enrolled":186,"enrolledBasis":"registry","outcomes":[{"endpoint":"Concordance of Blue Dye and Lymphoseek","primary":true,"unit":"proportion of lymph nodes","arms":[{"name":"Intent-To-Treat","n":136,"value":0.9767,"note":"95% CI 0.9466 to 0.9924; Figures from the ClinicalTrials.gov results section (first posted 2013-06-03), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00671918?tab=results"}]},{"id":"nct05997017","kind":"trial","name":"Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer","aka":[],"tldr":"A phase 2 trial of Sirolimus protein-bound particles in endometrial cancer, run by Aadi Bioscience, Inc., now recruiting.","summary":"Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer is a phase 2 interventional study registered as NCT05997017 by Aadi Bioscience, Inc., with 29 participants planned, started 2023-12-28 and due to reach its primary completion in 2026-12. Interventions recorded: nab-sirolimus. Conditions listed: Endometrial Cancer, Endometrioid Tumor, Cancer, Tumor. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05997017","url":"https://clinicaltrials.gov/study/NCT05997017"}],"tags":["ctgov-ingest"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["sirolimus-albumin-bound"],"companies":["aadi-bioscience"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05997017","phase":"2","setting":"A Phase 2 Multi-center Open-label Trial of Nab-Sirolimus in Combination With Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer","sponsor":"Aadi Bioscience, Inc.","started":"2023-12-28","startedType":"actual","enrolled":29,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06510374","kind":"trial","name":"Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer","aka":["ABLE-32"],"tldr":"A phase 3 trial of Nadofaragene firadenovec in bladder & urothelial cancer, run by Ferring Pharmaceuticals, now recruiting.","summary":"Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer is a phase 3 interventional study registered as NCT06510374 by Ferring Pharmaceuticals, with 454 participants planned, started 2024-10-01 and due to reach its primary completion in 2028-06-30. Interventions recorded: Nadofaragene Firadenovec.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06510374","url":"https://clinicaltrials.gov/study/NCT06510374"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["bcg-and-intravesical-therapy"],"targets":[],"drugs":["nadofaragene-firadenovec"],"companies":["ferring"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06510374","phase":"3","setting":"A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer","sponsor":"Ferring Pharmaceuticals","started":"2024-10-01","startedType":"actual","enrolled":454,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07109414","kind":"trial","name":"Trial of NP-G2-044 (Prilukae) Combined With PLD for Treatment of Platinum-Resistant Ovarian Cancer (ULTIMUS-1)","aka":["ULTIMUS-1"],"tldr":"A phase 2/3 trial of NP-G2-044 in ovarian cancer, run by Novita Pharmaceuticals, Inc., active and no longer recruiting.","summary":"Trial of NP-G2-044 (Prilukae) Combined With PLD for Treatment of Platinum-Resistant Ovarian Cancer (ULTIMUS-1) is a phase 2/3 interventional study registered as NCT07109414 by Novita Pharmaceuticals, Inc., with 380 participants enrolled, started 2025-12-29 and due to reach its primary completion in 2028-10-25. Interventions recorded: NP-G2-044 and PLD.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07109414","url":"https://clinicaltrials.gov/study/NCT07109414"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["pegylated-liposomal-doxorubicin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07109414","phase":"2/3","setting":"Randomized Phase 2/3 Trial of NP-G2-044 (Prilukae) Combined With PLD for Treatment of Platinum-Resistant Ovarian Cancer (ULTIMUS-1)","sponsor":"Novita Pharmaceuticals, Inc.","started":"2025-12-29","startedType":"actual","enrolled":380,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07216443","kind":"trial","name":"Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome","aka":[],"tldr":"A phase 2 trial of Orca-T in myelodysplastic syndromes / neoplasms, run by Orca Biosystems, Inc., now recruiting.","summary":"Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome is a phase 2 interventional study registered as NCT07216443 by Orca Biosystems, Inc., with 80 participants planned, started 2025-12-09 and due to reach its primary completion in 2027-11. Interventions recorded: Orca-T.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07216443","url":"https://clinicaltrials.gov/study/NCT07216443"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mds","mds-higher-risk"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["orca-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07216443","phase":"2","setting":"A Phase 2 Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome","sponsor":"Orca Biosystems, Inc.","started":"2025-12-09","startedType":"actual","enrolled":80,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07064018","kind":"trial","name":"Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies","aka":["SPEDOX-6"],"tldr":"A phase 1/2 trial of pegfilgrastim and filgrastim (g-csf) in triple-negative breast cancer, run by University of California, Irvine, now recruiting.","summary":"Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies is a phase 1/2, interventional study registered as NCT07064018 by University of California, Irvine, with a registry enrolment figure of 67 participants, started 2025-04-30 and due to reach its primary completion in 2029-12-31. Interventions recorded: Spedox-6; Pegfilgrastim; Filgrastim. Conditions listed: Soft-tissue Sarcoma; Triple Negative Breast Cancer; Non-small Cell Lung Cancer; Cervical Cancer; Ovarian Cancer; KRAS Mutation-Related Tumors. Triple-negative eligibility wording from the registry: \"* Tumor types expected to express lower levels of FcRn relative to normal tissue including: STS, TNBC, cervical cancer, NSCLC, ovarian cancer, and KRAS mutated pancreatic ductal adenocarcinoma without requirement for testing FcRn level\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07064018","url":"https://clinicaltrials.gov/study/NCT07064018"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":["pegfilgrastim","filgrastim"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07064018","phase":"1/2","setting":"Phase Ib/IIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies","sponsor":"University of California, Irvine","started":"2025-04-30","startedType":"actual","enrolled":67,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05254327","kind":"trial","name":"Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by University of Nebraska, now recruiting.","summary":"Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001 is a phase 2, randomised interventional study registered as NCT05254327 by University of Nebraska, with a registry enrolment figure of 118 participants, started 2022-08-15 and due to reach its primary completion in 2027-05. Interventions recorded: BMX-001. Conditions listed: Rectal Cancer. Primary outcome: Efficacy of BMX-001 as measured by Grade 3 and above associated with gastrointestinal Toxicities; Efficacy of BMX-001 as measured by Grade 3 and above associated with genitourinary Toxicities; Efficacy of BMX-001 as measured by Grade 3 and above associated with skin Toxicities. Colorectal eligibility wording from the registry: \"Patients with pathologically confirmed locally advanced rectal adenocarcinoma who will be receiving total neoadjuvant therapy regimen with curative intent\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05254327","url":"https://clinicaltrials.gov/study/NCT05254327"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05254327","phase":"2","setting":"A Randomized Phase 2 Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With and Without BMX-001 as Part of Total Neoadjuvant Therapy in Patients With Newly Diagnosed Locally Advanced Rectal Adenocarcinoma","sponsor":"University of Nebraska","started":"2022-08-15","startedType":"actual","enrolled":118,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04542824","kind":"trial","name":"Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)","aka":["EPCORE NHL-3"],"tldr":"A phase 1/2 trial of Epcoritamab, Rituximab, Cyclophosphamide in diffuse large b-cell lymphoma and follicular lymphoma, run by Genmab, active and no longer recruiting.","summary":"Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL) is a phase 1/2 interventional study registered as NCT04542824 by Genmab, with 78 participants enrolled, started 2020-08-20 and due to reach its primary completion in 2027-09. Interventions recorded: Epcoritamab (monotherapy), Epcoritamab, Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, Gemcitabine and oxaliplatin, Epcoritamab (maintenance). Conditions listed: Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Follicular Lymphoma. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04542824","url":"https://clinicaltrials.gov/study/NCT04542824"}],"tags":["ctgov-ingest"],"related":[],"cancers":["dlbcl","follicular-lymphoma"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["epcoritamab","rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04542824","phase":"1/2","setting":"Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3×CD20) in Japanese Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A Phase 1/2, Open-Label, Dose-Escalation Trial With Expansion Cohorts","sponsor":"Genmab","started":"2020-08-20","startedType":"actual","enrolled":78,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06618235","kind":"trial","name":"Trial of THEO-260 in Ovarian Cancer Patients","aka":["OCTOPOD"],"tldr":"A phase 1/2 trial of THEO-260 in ovarian cancer, run by Theolytics Limited, now recruiting.","summary":"Trial of THEO-260 in Ovarian Cancer Patients is a phase 1/2 interventional study registered as NCT06618235 by Theolytics Limited, with 44 participants planned, started 2024-09-24 and due to reach its primary completion in 2028-06. Interventions recorded: THEO-260.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06618235","url":"https://clinicaltrials.gov/study/NCT06618235"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["theo-260"],"companies":["theolytics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06618235","phase":"1/2","setting":"A Phase I/IIa, Open-label, Dose Finding, Safety, Tolerability and Exploratory Trial of THEO-260 in Patients With High Grade Serous or Endometrioid Ovarian Cancer","sponsor":"Theolytics Limited","started":"2024-09-24","startedType":"actual","enrolled":44,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06472245","kind":"trial","name":"Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor","aka":["ARTEMIA"],"tldr":"A phase 3 trial testing OSE2101 in non-small-cell lung cancer, now recruiting.","summary":"Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor is a phase 3 interventional study registered as NCT06472245, led by OSE Immunotherapeutics with Exystat and GeneDx, and recruiting on the registry. Official title: A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor. Planned enrolment is 363 participants (estimated). The study started in 2024-12-03 and primary completion is expected in 2027-12-15. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06472245","url":"https://clinicaltrials.gov/study/NCT06472245"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ose2101"],"companies":["ose-immunotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06472245","phase":"3","setting":"A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor","sponsor":"OSE Immunotherapeutics","started":"2024-12-03","startedType":"actual","enrolled":363,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05853575","kind":"trial","name":"Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)","aka":["KRYSTAL 21"],"tldr":"A phase 2 trial of Adagrasib in metastatic cancer, run by Mirati Therapeutics Inc., active and no longer recruiting.","summary":"Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21) is a phase 2 interventional study registered as NCT05853575 by Mirati Therapeutics Inc., with 200 participants planned, started 2024-02-01 and due to reach its primary completion in 2026-10-30. Interventions recorded: Adagrasib. Conditions listed: Advanced Cancer, Metastatic Cancer, Malignant Neoplasm of Lung. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05853575","url":"https://clinicaltrials.gov/study/NCT05853575"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["kras-inhibitors"],"targets":[],"drugs":["adagrasib"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05853575","phase":"2","setting":"A Randomized Study of Two Dosing Regimens of Adagrasib in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation","sponsor":"Mirati Therapeutics Inc.","started":"2024-02-01","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06291064","kind":"trial","name":"Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer","aka":["TARMAC"],"tldr":"A phase 2 trial of cyclophosphamide, epirubicin, docetaxel, carboplatin and other drugs in triple-negative breast cancer, run by University of Chicago, now recruiting.","summary":"Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer is a phase 2, interventional study registered as NCT06291064 by University of Chicago, with a registry enrolment figure of 85 participants, started 2025-03-18 and due to reach its primary completion in 2029-06. Interventions recorded: Cyclophosphamide; Epirubicin; Docetaxel; Carboplatin; Breast Surgery; Capecitabine. Conditions listed: Triple Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"Patients with histologically confirmed carcinoma of the female breast with triple-negative status by immunohistochemistry (IHC)\". Sites: Nigeria. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06291064","url":"https://clinicaltrials.gov/study/NCT06291064"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["cyclophosphamide","epirubicin","docetaxel","carboplatin","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06291064","phase":"2","setting":"TreAtment Response and Omic-Markers in Triple-Negative Breast CAncer Patients Receiving Standard of Care Chemotherapy (TARMAC)","sponsor":"University of Chicago","started":"2025-03-18","startedType":"actual","enrolled":85,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06635824","kind":"trial","name":"Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)","aka":["ABBIL1TY NSCLC-06"],"tldr":"A phase 3 trial testing Acasunlimab in non-small-cell lung cancer, active and no longer recruiting.","summary":"Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06) is a phase 3 interventional study registered as NCT06635824, led by Genmab, and active but no longer recruiting on the registry. Official title: A Prospective, Open-Label, Randomised, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC-06). Planned enrolment is 191 participants (actual). The study started in 2024-11-25 and primary completion is expected in 2027-07-30. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06635824","url":"https://clinicaltrials.gov/study/NCT06635824"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["acasunlimab"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06635824","phase":"3","setting":"A Prospective, Open-Label, Randomized, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC-06)","sponsor":"Genmab","started":"2024-11-25","startedType":"actual","enrolled":191,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07805252","kind":"trial","name":"Trial to Study the Safety, Pharmacokinetics and Preliminary Antitumour Activity of ODM-216 in Patients With Cancer","aka":["BICIDES"],"tldr":"A phase 1/2 trial of ODM-216 in advanced solid tumours, run by Orion Corporation, Orion Pharma, now recruiting.","summary":"Trial to Study the Safety, Pharmacokinetics and Preliminary Antitumour Activity of ODM-216 in Patients With Cancer is a phase 1/2 interventional study registered as NCT07805252 by Orion Corporation, Orion Pharma, with 195 participants planned, started 2026-09-03 and due to reach its primary completion in 2028-01-10. Interventions recorded: ODM-216.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07805252","url":"https://clinicaltrials.gov/study/NCT07805252"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["orion-orion-pharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07805252","phase":"1/2","setting":"A Phase 1/2, Open-Label, First-in-Human Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumour Activity of ODM-216 in Participants With Advanced Solid Tumours","sponsor":"Orion Corporation, Orion Pharma","started":"2026-09-03","startedType":"actual","enrolled":195,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06569368","kind":"trial","name":"Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by M.D. Anderson Cancer Center, now recruiting.","summary":"Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy is a phase 2, randomised interventional study registered as NCT06569368 by M.D. Anderson Cancer Center, with a registry enrolment figure of 60 participants, started 2024-07-10 and due to reach its primary completion in 2027-10-31. Interventions recorded: Metronidazole. Conditions listed: Rectal Adenocarcinoma. Primary outcome: Safety and adverse events (AEs). Colorectal eligibility wording from the registry: \"* Participants with locally advanced rectal cancers (T3, T4, or N+ disease) with decision to treat with total neoadjuvant therapy\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06569368","url":"https://clinicaltrials.gov/study/NCT06569368"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06569368","phase":"2","setting":"A Phase II Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy","sponsor":"M.D. Anderson Cancer Center","started":"2024-07-10","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"triangle","kind":"trial","name":"TRIANGLE","aka":["MCL Younger 2","European MCL Network TRIANGLE"],"tldr":"TRIANGLE showed that adding the pill ibrutinib to the chemotherapy given to younger people with mantle cell lymphoma keeps the disease away for longer, and that when ibrutinib is used the stem cell transplant that used to be compulsory no longer adds a clear benefit while adding side effects.","summary":"TRIANGLE was a three-arm open-label phase 3 trial of the European Mantle Cell Lymphoma Network in 870 patients aged 18 to 65 with untreated stage II to IV mantle cell lymphoma, randomised to standard R-CHOP/R-DHAP induction and autologous transplant (arm A), the same with ibrutinib during R-CHOP cycles and for two years of maintenance (arm A+I), or ibrutinib-containing induction and maintenance without transplant (arm I). The primary endpoint was failure-free survival.\n\nAfter 31 months of median follow-up, three-year failure-free survival was 88 percent in arm A+I against 72 percent in arm A (hazard ratio 0.52), while superiority of arm A over arm I was not shown (72 against 86 percent); the comparison of A+I against I continues. Grade 3 to 5 haematological adverse events and infections during maintenance were far more frequent after transplant plus ibrutinib than with ibrutinib alone. The corpus's mantle cell lymphoma page cites TRIANGLE for the conclusion that transplant no longer adds benefit when ibrutinib is used.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02858258","url":"https://clinicaltrials.gov/study/NCT02858258"}],"tags":["soc-trials"],"related":["lymphoma-roadmap","lyma","enrich","shine"],"cancers":["mantle-cell-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["kinase-inhibitors","autologous-stem-cell-transplant","cytotoxic-chemotherapy"],"targets":[],"drugs":["ibrutinib","rituximab","cytarabine","cyclophosphamide","doxorubicin","vincristine","prednisone","cisplatin"],"companies":[],"institutions":["lmu-munich"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-triangle-ibrutinib-mantle-cell-lymphoma-dreyling-lancet-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02858258","phase":"3","setting":"Previously untreated mantle cell lymphoma in patients up to 65 fit for transplant: alternating R-CHOP and R-DHAP induction followed by autologous transplant (arm A), the same with ibrutinib added to induction and as two-year maintenance (arm A+I), or ibrutinib-containing induction and maintenance without transplant (arm I)","sponsor":"European Mantle Cell Lymphoma Network (LMU Klinikum, Munich)","result":"Three-year failure-free survival 88 percent with ibrutinib added to induction, transplant and maintenance against 72 percent with standard induction and transplant (hazard ratio 0.52); transplant was not shown to be superior to an ibrutinib-containing regimen without transplant (72 against 86 percent).","started":"2016-07","yearReported":2024,"enrolled":870,"enrolledBasis":"registry","outcomes":[{"endpoint":"Failure-free survival at 3 years, arm A+I against arm A","primary":true,"unit":"%","arms":[{"name":"Arm A+I: R-CHOP/R-DHAP + ibrutinib, transplant, ibrutinib maintenance","n":292,"value":88,"note":"95% CI 84 to 92; median follow-up 31 months"},{"name":"Arm A: R-CHOP/R-DHAP and autologous transplant","n":288,"value":72,"note":"95% CI 67 to 79"}],"hr":0.52,"p":"0.0008 (one-sided)","source":"https://doi.org/10.1016/S0140-6736(24)00184-3"},{"endpoint":"Failure-free survival at 3 years, arm A against arm I (superiority of transplant not shown)","primary":true,"unit":"%","arms":[{"name":"Arm A: R-CHOP/R-DHAP and autologous transplant","n":288,"value":72},{"name":"Arm I: R-CHOP/R-DHAP + ibrutinib, ibrutinib maintenance, no transplant","n":290,"value":86,"note":"95% CI 82 to 91"}],"hr":1.77,"p":"0.9979 (one-sided)","source":"https://doi.org/10.1016/S0140-6736(24)00184-3"},{"endpoint":"Grade 3 to 5 haematological adverse events during maintenance or follow-up","unit":"%","arms":[{"name":"Arm A+I","n":231,"value":50},{"name":"Arm I","n":269,"value":28},{"name":"Arm A","n":238,"value":21}],"source":"https://doi.org/10.1016/S0140-6736(24)00184-3"},{"endpoint":"Grade 3 to 5 infections during maintenance or follow-up","unit":"%","arms":[{"name":"Arm A+I","n":231,"value":25},{"name":"Arm I","n":269,"value":19},{"name":"Arm A","n":238,"value":13}],"source":"https://doi.org/10.1016/S0140-6736(24)00184-3"}]},{"id":"tribe","kind":"trial","name":"TRIBE","aka":[],"tldr":"Giving all three chemotherapy drugs at once instead of two shrank more tumours and delayed progression, at the cost of more side effects.","summary":"TRIBE randomised 508 patients with untreated metastatic colorectal cancer to FOLFIRI plus bevacizumab or FOLFOXIRI plus bevacizumab, up to twelve cycles followed by fluorouracil and bevacizumab maintenance. Median progression-free survival was 12.1 against 9.7 months (hazard ratio 0.75, 95% CI 0.62 to 0.90, p=0.003) and the objective response rate 65 against 53 percent (p=0.006). Overall survival was longer but not significantly so in the primary report (31.0 against 25.8 months, hazard ratio 0.79, p=0.054). Grade 3 or 4 neurotoxicity, stomatitis, diarrhoea and neutropenia were all more common with the triplet. TRIBE is why FOLFOXIRI plus bevacizumab is chosen when tumour shrinkage matters most: in BRAF-mutant disease, in young fit patients and when liver metastases might be made resectable.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00719797","url":"https://clinicaltrials.gov/study/NCT00719797"},{"label":"TRIBE: initial therapy with FOLFOXIRI and bevacizumab for metastatic colorectal cancer (New England Journal of Medicine 2014)","url":"https://doi.org/10.1056/NEJMoa1403108"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","antiangiogenic","platinum","topoisomerase-inhibitors"],"targets":["vegf"],"drugs":["folfoxiri","folfiri","bevacizumab","irinotecan","oxaliplatin","fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["tribe2","cairo5"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00719797","phase":"3","setting":"Untreated metastatic colorectal cancer: FOLFOXIRI plus bevacizumab against FOLFIRI plus bevacizumab","sponsor":"Gruppo Oncologico del Nord-Ovest","result":"Progression-free survival 12.1 against 9.7 months (hazard ratio 0.75); response rate 65 against 53 percent.","started":"2008-07","yearReported":2014,"enrolled":508,"enrolledBasis":"randomised","enrolledNote":"The registry lists 509 participants; 508 were randomised in the New England Journal of Medicine report.","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"FOLFOXIRI plus bevacizumab","value":12.1},{"name":"FOLFIRI plus bevacizumab","value":9.7}],"hr":0.75,"ci":[0.62,0.9],"p":"0.003","source":"https://doi.org/10.1056/NEJMoa1403108"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"FOLFOXIRI plus bevacizumab","value":31},{"name":"FOLFIRI plus bevacizumab","value":25.8}],"hr":0.79,"p":"0.054","source":"https://doi.org/10.1056/NEJMoa1403108"}],"replication":"TRIBE2 confirmed the strategy against a planned sequence of doublets; CAIRO5 found FOLFOXIRI plus bevacizumab best for right-sided or RAS/BRAF-mutant liver-only disease."},{"id":"tribe2","kind":"trial","name":"TRIBE2","aka":[],"tldr":"Testing the triplet as a whole strategy rather than one line of treatment. Using all three drugs first, and again after progression, worked better than saving them.","summary":"TRIBE2 randomised 679 patients with unresectable, previously untreated metastatic colorectal cancer to upfront FOLFOXIRI plus bevacizumab with reintroduction of the same regimen after progression, or to mFOLFOX6 plus bevacizumab followed by FOLFIRI plus bevacizumab. The primary endpoint, progression-free survival 2 (time to progression on any second-line treatment), was 19.2 against 16.4 months (hazard ratio 0.74, 95% CI 0.63 to 0.88, p=0.0005). Grade 3 or 4 diarrhoea (17 against 5 percent) and neutropenia (50 against 21 percent) were more common with the triplet during first-line treatment, and eight treatment-related deaths occurred in the experimental group against four in the control group. The trial answered the objection to TRIBE, that the triplet merely front-loads drugs that would have been used anyway.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02339116","url":"https://clinicaltrials.gov/study/NCT02339116"},{"label":"TRIBE2: upfront FOLFOXIRI plus bevacizumab and reintroduction after progression (Lancet Oncology 2020)","url":"https://doi.org/10.1016/S1470-2045(19)30862-9"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["cytotoxic-chemotherapy","antiangiogenic"],"targets":["vegf"],"drugs":["folfoxiri","folfox","folfiri","bevacizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["tribe"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02339116","phase":"3","setting":"Untreated metastatic colorectal cancer: upfront FOLFOXIRI plus bevacizumab with reintroduction after progression, against sequential mFOLFOX6 then FOLFIRI, each with bevacizumab","sponsor":"Gruppo Oncologico del Nord-Ovest","result":"Progression-free survival 2 of 19.2 against 16.4 months (hazard ratio 0.74).","started":"2015-02-26","startedType":"actual","yearReported":2020,"enrolled":679,"enrolledBasis":"randomised","enrolledNote":"The registry lists 654 participants; 679 were randomised and treated in the Lancet Oncology report.","outcomes":[{"endpoint":"Progression-free survival 2","primary":true,"unit":"months","arms":[{"name":"Upfront FOLFOXIRI plus bevacizumab","n":339,"value":19.2},{"name":"Sequential doublets plus bevacizumab","n":340,"value":16.4}],"hr":0.74,"ci":[0.63,0.88],"p":"0.0005","source":"https://doi.org/10.1016/S1470-2045(19)30862-9"}]},{"id":"nct05007132","kind":"trial","name":"Trifluridine/ Tipiracil Plus Panitumumab Versus Trifluridine/ Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer","aka":["FIRE-8"],"tldr":"A phase 2 trial of bevacizumab (glioblastoma use) in colorectal cancer, run by Dominik Paul Modest, now recruiting.","summary":"Trifluridine/ Tipiracil Plus Panitumumab Versus Trifluridine/ Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT05007132 by Dominik Paul Modest, with a registry enrolment figure of 153 participants, started 2021-12-17 and due to reach its primary completion in 2029-12. Interventions recorded: Panitumumab 20 milligram/ML; Bevacizumab; Trifluridine/Tipiracil Hydrochloride. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Objective response rate. Colorectal eligibility wording from the registry: \"Histologically confirmed adenocarcinoma of the colon or rectum\". Sites: Germany. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05007132","url":"https://clinicaltrials.gov/study/NCT05007132"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab-glioma"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05007132","phase":"2","setting":"Prospective, Randomized, Open, Multicenter Phase II Trial to Investigate the Efficacy of Trifluridine/Tipiracil Plus Panitumumab Versus Trifluridine/Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer: FIRE-8; AIO-KRK/YMO-0519","sponsor":"Dominik Paul Modest","started":"2021-12-17","startedType":"actual","enrolled":153,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07146646","kind":"trial","name":"Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of oxaliplatin and trifluridine tipiracil in gallbladder cancer and other biliary tract cancers, run by Case Comprehensive Cancer Center, now recruiting.","summary":"Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer is a phase 2 interventional study registered as NCT07146646 by Case Comprehensive Cancer Center, with a registry enrolment figure of 27 participants, started 2025-12-01 and due to reach its primary completion in 2027-02. Interventions recorded: Trifluridine/tipiracil, Oxaliplatin. Conditions listed: Biliary Tract Cancer, Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Cancer, Gallbladder Carcinoma. Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07146646","url":"https://clinicaltrials.gov/study/NCT07146646"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["oxaliplatin","trifluridine-tipiracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07146646","phase":"2","setting":"A Phase II Trial of Trifluridine/Tipiracil Plus Oxaliplatin in Patients With Advanced or Metastatic Biliary Tract Cancer Following First-Line Therapy","sponsor":"Case Comprehensive Cancer Center","started":"2025-12-01","startedType":"actual","enrolled":27,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07261709","kind":"trial","name":"Trifluridine/Tipiracil Plus Fruquintinib vs. Trifluridine/Tipiracil Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Sun Yat-sen University, not yet recruiting.","summary":"Trifluridine/Tipiracil Plus Fruquintinib vs. Trifluridine/Tipiracil Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority Trial is a phase 2, randomised interventional study registered as NCT07261709 by Sun Yat-sen University, with a registry enrolment figure of 236 participants, started 2025-12-01 and due to reach its primary completion in 2027-10-30. Interventions recorded: Trifluridine/tipiracil plus fruquintinib; trifluridine/tipiracil plus bevacizumab. Conditions listed: Refractory Metastatic Colorectal Cancer. Primary outcome: PFS. Colorectal eligibility wording from the registry: \"Histologically confirmed unresectable colorectal cancer\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07261709","url":"https://clinicaltrials.gov/study/NCT07261709"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07261709","phase":"2","setting":"Trifluridine/Tipiracil Plus Fruquintinib vs. Trifluridine/Tipiracil Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority Trial","sponsor":"Sun Yat-sen University","started":"2025-12-01","startedType":"estimated","enrolled":236,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06992648","kind":"trial","name":"Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer","aka":["REGTAS-2"],"tldr":"A phase 3 trial in colorectal cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine, now recruiting.","summary":"Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT06992648 by Second Affiliated Hospital, Zhejiang University, School of Medicine, with a registry enrolment figure of 302 participants, started 2025-04-01 and due to reach its primary completion in 2027-12-31. Interventions recorded: Trifluridine/Tipiracil + Regorafenib; Trifluridine/tipiracil + bevacizumab. Conditions listed: Colorectal Cancer Metastatic; Colorectal Cancer Recurrent. Primary outcome: Progression free survival. Colorectal eligibility wording from the registry: \"Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded);\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06992648","url":"https://clinicaltrials.gov/study/NCT06992648"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06992648","phase":"3","setting":"Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority Trial","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","started":"2025-04-01","startedType":"actual","enrolled":302,"enrolledBasis":"registry","outcomes":[]},{"id":"trilynx","kind":"trial","name":"TrilynX","aka":[],"tldr":"TrilynX tested xevinapant, a drug meant to make tumours more sensitive to radiation, with cisplatin chemoradiation in 730 patients with locally advanced head and neck cancer. Despite a striking phase 2 result, the phase 3 was stopped for futility in 2024 with worse outcomes on xevinapant, a reminder that early wins in this disease often do not replicate.","summary":"TrilynX, trial NCT04459715 sponsored by Merck KGaA under licence from Debiopharm and reported in 2024, tested xevinapant, a drug meant to sensitise tumours to radiation, with cisplatin chemoradiation in unresected locally advanced head and neck cancer, and it made things worse. It randomised 730 patients and was terminated on 24 June 2024 for futility at an interim analysis, with shorter event-free survival on xevinapant than placebo, attributed partly to toxicity and treatment interruptions, after a phase 2 with a striking survival benefit; development of xevinapant was discontinued and a second phase 3, X-Ray Vision, was stopped. OnCo links it to head and neck cancer, modern external beam radiotherapy and Debiopharm. It is a reminder that early wins in this disease often do not replicate, and why a promising phase 2 reversed so completely is the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04459715","url":"https://clinicaltrials.gov/study/NCT04459715"},{"label":"JCO 2025","url":"https://ascopubs.org/doi/10.1200/JCO-25-00272"}],"tags":["failure","lesson:phase-2-to-3-attrition"],"related":[],"cancers":["head-and-neck","hpv-negative-head-and-neck-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["xevinapant"],"companies":["debiopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04459715","phase":"3","setting":"Unresected locally advanced HNSCC: xevinapant + cisplatin chemoradiation vs placebo + chemoradiation","sponsor":"Merck KGaA (Debiopharm licence)","result":"EFS 19.4 vs 33.1 months (worse with xevinapant).","started":"2020-08-07","startedType":"actual","yearReported":2024,"enrolled":730,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival","primary":true,"unit":"months","arms":[{"name":"Xevinapant + CRT","value":19.4},{"name":"Placebo + CRT","value":33.1}],"source":"https://ascopubs.org/doi/10.1200/JCO-25-00272"}],"replication":"The phase 2 result was not reproduced; a second phase 3 (X-Ray Vision) was stopped."},{"id":"nct06135896","kind":"trial","name":"Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers","aka":["Dulastin"],"tldr":"A phase 2 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by National Cancer Center, Korea, now recruiting.","summary":"Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers is a phase 2, randomised interventional study registered as NCT06135896 by National Cancer Center, Korea, with a registry enrolment figure of 98 participants, started 2024-01-16 and due to reach its primary completion in 2026-06-30. Interventions recorded: Tripegfilgrastim. Conditions listed: Unresectable Pancreatic Cancer, Unresectable Bile Duct Carcinoma, Unresectable Biliary Tract Carcinoma. Sites: South Korea. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06135896","url":"https://clinicaltrials.gov/study/NCT06135896"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06135896","phase":"2","setting":"An Open-label, Randomized, Multicenter, Phase II Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers","sponsor":"National Cancer Center, Korea","started":"2024-01-16","startedType":"actual","enrolled":98,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07104266","kind":"trial","name":"Triple Negative Breast Cancer and Celecoxib. Pilot Study","aka":[],"tldr":"A phase 2 trial of celecoxib in triple-negative breast cancer, run by Université de Sherbrooke, now recruiting.","summary":"Triple Negative Breast Cancer and Celecoxib. Pilot Study is a phase 2, randomised interventional study registered as NCT07104266 by Université de Sherbrooke, with a registry enrolment figure of 30 participants, started 2025-08-04 and due to reach its primary completion in 2028-08-04. Interventions recorded: Celecoxib (Celebrex); Placebo. Conditions listed: Triple-Negative Breast Cancer. Triple-negative eligibility wording from the registry: \"* TNBC status confirmed by pathology\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07104266","url":"https://clinicaltrials.gov/study/NCT07104266"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":[],"targets":[],"drugs":["celecoxib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07104266","phase":"2","setting":"Determine Whether Administering Celecoxib During Radiotherapy Can Reduce the Risk of Recurrence of Triple-negative Breast Cancer. Pilot Study","sponsor":"Université de Sherbrooke","started":"2025-08-04","startedType":"estimated","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03975049","kind":"trial","name":"Triplet Combination or Doublet Regimen Versus Chemoradiation as Neoadjuvant Therapy for Locally Advanced Rectal Cancer","aka":[],"tldr":"A phase 3 trial in colorectal cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University, not yet recruiting.","summary":"Triplet Combination or Doublet Regimen Versus Chemoradiation as Neoadjuvant Therapy for Locally Advanced Rectal Cancer is a phase 3, randomised interventional study registered as NCT03975049 by Sixth Affiliated Hospital, Sun Yat-sen University, with a registry enrolment figure of 933 participants, started 2019-08 and due to reach its primary completion in 2024-07. Interventions recorded: Chemoradiation; FOLFOXIRI Protocol; Folfox Protocol. Conditions listed: Rectal Cancer; Chemotherapy Effect. Primary outcome: Disease-free survival. Colorectal eligibility wording from the registry: \"* 2）Histological diagnosis of rectal adenocarcinoma;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03975049","url":"https://clinicaltrials.gov/study/NCT03975049"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03975049","phase":"3","setting":"A Prospectively Randomized Phase III Trial Comparing Short-term mFOLFOXIRI, Long-term mFOLFOX6 and Traditional Chemoradiation as Preoperative Neoadjuvant Therapy for Locally Advanced Rectal Cancer","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","started":"2019-08","startedType":"estimated","enrolled":933,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05187338","kind":"trial","name":"Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of ipilimumab, pembrolizumab and durvalumab in pancreatic cancer, run by Second Affiliated Hospital of Guangzhou Medical University, now recruiting.","summary":"Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors is a phase 1/2, interventional study registered as NCT05187338 by Second Affiliated Hospital of Guangzhou Medical University, with a registry enrolment figure of 100 participants, started 2021-11-01 and due to reach its primary completion in 2029-10-30. Interventions recorded: ipilimumab +pembrolizumab +durvalumab. Conditions listed: Lung Cancer; Liver Cancer; Colorectal Cancer; Pancreas Cancer; Ovary Cancer; Head and Neck Cancer; Breast Cancer; Gastric Cancer; Cervical Cancer; Esophageal Cancer; Sarcoma. Primary outcome: Safety of 3 drugs combination treatment; Progression-free survival; Disease control rate. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05187338","url":"https://clinicaltrials.gov/study/NCT05187338"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["ipilimumab","pembrolizumab","durvalumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05187338","phase":"1/2","setting":"Triplex CTLA4/PD1/PDL1 Checkpoint Inhibitors Combination Therapy for Advanced Solid Tumors","sponsor":"Second Affiliated Hospital of Guangzhou Medical University","started":"2021-11-01","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00066703","kind":"trial","name":"Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer","aka":["TEXT"],"tldr":"A phase 3 trial of Tamoxifen and Triptorelin in Breast cancer, run by ETOP IBCSG Partners Foundation, completed.","summary":"Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer is a phase 3 interventional study registered as NCT00066703 by ETOP IBCSG Partners Foundation, with 2672 participants recorded, started 2003-11-03 and reaching its primary completion in 2011-03-11. Interventions recorded: exemestane, tamoxifen, triptorelin. Conditions recorded: Breast Cancer.\n\nLinked to the drug Triptorelin because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00066703","url":"https://clinicaltrials.gov/study/NCT00066703"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tamoxifen","triptorelin"],"companies":["etop-ibcsg"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00066703","phase":"3","setting":"A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer","sponsor":"ETOP IBCSG Partners Foundation","started":"2003-11-03","startedType":"actual","yearReported":2016,"enrolled":2672,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free Survival","primary":true,"unit":"%","arms":[{"name":"T+OFS","n":1328,"value":87.3,"note":"95% CI 85.7 to 88.7; Figures from the ClinicalTrials.gov results section (first posted 2016-04-05), not from a publication"},{"name":"E+OFS","n":1332,"value":91.1,"note":"95% CI 89.7 to 92.3"}],"hr":0.717,"ci":[0.602,0.855],"p":".0002","source":"https://clinicaltrials.gov/study/NCT00066703?tab=results"},{"endpoint":"Overall Survival","unit":"%","arms":[{"name":"T+OFS","n":1328,"value":93.3,"note":"95% CI 92.1 to 94.3; Figures from the ClinicalTrials.gov results section (first posted 2016-04-05), not from a publication"},{"name":"E+OFS","n":1332,"value":93.4,"note":"95% CI 92.2 to 94.4"}],"hr":0.98,"ci":[0.79,1.22],"p":"0.84","source":"https://clinicaltrials.gov/study/NCT00066703?tab=results"}]},{"id":"nct00104741","kind":"trial","name":"Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer","aka":[],"tldr":"A phase 3 trial of Flutamide and Triptorelin in Prostate cancer, run by UNICANCER, completed.","summary":"Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer is a phase 3 interventional study registered as NCT00104741 by UNICANCER, with 378 participants recorded, started 2003-09-10 and reaching its primary completion in 2015-10. Interventions recorded: flutamide, triptorelin, radiation therapy. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Flutamide because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00104741","url":"https://clinicaltrials.gov/study/NCT00104741"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["flutamide","triptorelin"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00104741","phase":"3","setting":"Multicentre Randomized Trial Assessing the Efficacy of a Short Neoadjuvant and Concomitant Hormone Therapy to an Exclusive Curative Cornformational Radiotherapy of Locolized Prostate Cancer With Intermediate Prognosis","sponsor":"UNICANCER","started":"2003-09-10","startedType":"actual","enrolled":378,"enrolledBasis":"registry","outcomes":[]},{"id":"triton3","kind":"trial","name":"TRITON3","aka":["TRITON3","rucaparib in BRCA or ATM altered mCRPC"],"tldr":"A PARP inhibitor works for men whose prostate cancer carries a BRCA fault, and does not work for men whose fault is in ATM. Which gene is broken decides whether the drug helps.","summary":"TRITON3 is the cleanest demonstration in prostate cancer that homologous recombination repair is not one thing. Of 4,855 men prescreened or screened, 405 were randomised 2:1 to rucaparib 600 mg twice daily (270) or physician's choice of docetaxel or a second androgen receptor pathway inhibitor (135). Of these, 201 and 101 had a BRCA alteration.\n\nAt 62 months, imaging-based progression-free survival was significantly longer with rucaparib in the BRCA subgroup, median 11.2 against 6.4 months, hazard ratio 0.50 (95 percent confidence interval 0.36 to 0.69), and in the intention-to-treat population, 10.2 against 6.4 months, hazard ratio 0.61 (0.47 to 0.80), p<0.001 for both.\n\nIn the exploratory ATM subgroup, median imaging-based progression-free survival was 8.1 months with rucaparib and 6.8 months with control, hazard ratio 0.95 (0.59 to 1.52). That is no effect. ATM is routinely counted as a homologous recombination repair gene on panel reports, and TRITON3 is the evidence that counting it that way over-promises.\n\nThe most frequent adverse events with rucaparib were fatigue and nausea. The screening ratio, 4,855 to 405, is worth quoting to any man being offered genomic testing: the eligible genotype is uncommon, and a negative result is the usual result.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02975934","url":"https://clinicaltrials.gov/study/NCT02975934"},{"label":"TRITON3 (New England Journal of Medicine 2023)","url":"https://doi.org/10.1056/NEJMoa2214676"},{"label":"NICE TA887: olaparib for previously treated BRCA mutation-positive hormone-relapsed metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta887"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["parp-inhibitor","germline-testing"],"targets":["brca","atm","parp"],"drugs":["rucaparib"],"companies":["clovis-oncology"],"institutions":[],"pathways":[],"terms":["hrd","castration-resistance"],"trials":["profound","propel","magnitude","talapro-2"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02975934","phase":"3","setting":"Metastatic castration-resistant prostate cancer with a BRCA1, BRCA2 or ATM alteration and progression after a second-generation androgen receptor pathway inhibitor: rucaparib 600 mg twice daily against physician's choice of docetaxel or a second androgen receptor pathway inhibitor, randomised 2:1, with imaging-based progression-free survival by independent review as the primary outcome","sponsor":"Clovis Oncology","result":"Median imaging-based progression-free survival 11.2 against 6.4 months in the BRCA subgroup (hazard ratio 0.50, 95 percent confidence interval 0.36 to 0.69) and 10.2 against 6.4 months overall (0.61, 0.47 to 0.80); no effect in the ATM subgroup (0.95, 0.59 to 1.52).","started":"2017-06-13","startedType":"actual","yearReported":2023,"enrolled":405,"enrolledBasis":"randomised","enrolledNote":"4,855 men were prescreened or screened to randomise 405; the screening figure is the one that shows how rare the eligible genotype is.","outcomes":[{"endpoint":"Imaging-based progression-free survival, BRCA subgroup (median)","primary":true,"unit":"months","arms":[{"name":"Rucaparib 600 mg twice daily","n":201,"value":11.2},{"name":"Physician's choice","n":101,"value":6.4}],"hr":0.5,"ci":[0.36,0.69],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa2214676"},{"endpoint":"Imaging-based progression-free survival, intention to treat (median)","unit":"months","arms":[{"name":"Rucaparib 600 mg twice daily","n":270,"value":10.2},{"name":"Physician's choice","n":135,"value":6.4}],"hr":0.61,"ci":[0.47,0.8],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa2214676"},{"endpoint":"Imaging-based progression-free survival, ATM subgroup (median)","unit":"months","arms":[{"name":"Rucaparib 600 mg twice daily","value":8.1,"note":"Exploratory analysis; no benefit."},{"name":"Physician's choice","value":6.8}],"hr":0.95,"ci":[0.59,1.52],"source":"https://doi.org/10.1056/NEJMoa2214676"}],"replication":"PROfound found the same gene-dependence, with a larger effect in BRCA1, BRCA2 and ATM combined than in the wider homologous recombination repair panel; PROpel, MAGNITUDE and TALAPRO-2 tested PARP inhibitors with an androgen receptor pathway inhibitor in the first line."},{"id":"triumph","kind":"trial","name":"TRIUMPH","aka":[],"tldr":"The first trial to let a blood test alone enrol people into a targeted treatment, and to show it selects as well as a tumour biopsy does.","summary":"TRIUMPH, run inside Japan's SCRUM-Japan screening platform, tested pertuzumab with trastuzumab in metastatic colorectal cancer whose HER2 amplification was confirmed prospectively either in tumour tissue or in circulating tumour DNA. Thirty patients were treated. The study met its primary endpoint with a confirmed objective response rate of 30 percent in the 27 tissue-positive patients and 28 percent in the 25 ctDNA-positive patients, against 0 percent in a matched real-world reference population on standard salvage therapy. Baseline ctDNA genotyping of HER2 copy number and concurrent oncogenic alterations, adjusted for tumour fraction, stratified patients for benefit about as well as tissue genotyping did, and a fall in ctDNA fraction at three weeks tracked response. A 2026 analysis of 66 enrolled patients found that previous anti-EGFR therapy (median overall survival 10.9 against 19.7 months) and resistance alterations detected in baseline ctDNA (no responses, median overall survival 7.6 against 16.5 months) both predict failure. TRIUMPH is the proof that liquid biopsy can be the entry criterion for a trial, not just a description of it.","status":"positive","asOf":"2026-09-24","links":[{"label":"TRIUMPH: circulating tumour DNA-guided treatment with pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer (Nature Medicine 2021)","url":"https://doi.org/10.1038/s41591-021-01553-w"},{"label":"TRIUMPH: prior anti-EGFR therapy and ctDNA resistance alterations predict failure (ESMO Open 2026)","url":"https://doi.org/10.1016/j.esmoop.2026.107734"},{"label":"UMIN000027887","url":"https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031885"}],"tags":[],"related":[],"cancers":["colorectal","her2-amplified-colorectal"],"sections":[],"technologies":["monoclonal-antibody","liquid-biopsy"],"targets":["her2"],"drugs":["pertuzumab","trastuzumab"],"companies":[],"institutions":["ncc-japan"],"pathways":[],"terms":["ctdna"],"trials":["heracles","mypathway","mountaineer","destiny-crc01"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"2","setting":"HER2-amplified metastatic colorectal cancer, amplification confirmed prospectively in tumour tissue or in circulating tumour DNA: pertuzumab with trastuzumab","sponsor":"National Cancer Center Hospital East / SCRUM-Japan","result":"Confirmed objective response 30 percent in tissue-positive and 28 percent in ctDNA-positive patients, against 0 percent in a matched real-world reference group.","yearReported":2021,"enrolled":30,"enrolledBasis":"treated","enrolledNote":"30 patients with HER2 amplification confirmed in tissue or circulating tumour DNA were treated; the trial is registered as UMIN000027887 and has no ClinicalTrials.gov record.","outcomes":[{"endpoint":"Confirmed objective response rate","primary":true,"unit":"percent","arms":[{"name":"Tissue HER2-positive","n":27,"value":30},{"name":"ctDNA HER2-positive","n":25,"value":28}],"source":"https://doi.org/10.1038/s41591-021-01553-w"}],"replication":"Consistent with HERACLES, MyPathway, MOUNTAINEER and DESTINY-CRC01 and CRC02 on the size of HER2-directed activity in this disease."},{"id":"trog-05-01","kind":"trial","name":"TROG 05.01 (chemotherapy added to radiotherapy after surgery for high-risk skin squamous cell carcinoma)","aka":["TROG 05.01","POST trial","Trans Tasman Radiation Oncology Group 05.01"],"tldr":"Adding chemotherapy to the radiotherapy given after surgery for the most dangerous skin squamous cancers did not help. What the trial did show is how well surgery and radiotherapy already work: more than four in five of these high-risk cancers were still controlled five years later.","summary":"Cutaneous squamous cell carcinoma of the head and neck with involved nodes or aggressive local features is the form of keratinocyte cancer that kills people, and the head and neck oncology habit of adding chemotherapy to postoperative radiotherapy was being carried across to it without evidence. TROG 05.01 randomised 321 patients, 310 of whom started their allocated treatment, to radiotherapy alone or radiotherapy with weekly carboplatin. Seventy-seven per cent had high-risk nodal disease, 19 per cent high-risk primary or in-transit disease and 4 per cent both. The median radiotherapy dose was 60 Gy and 84 per cent of the chemoradiotherapy arm completed six cycles of carboplatin.\n\nAt a median follow-up of 60 months, freedom from locoregional relapse at two and five years was 88 and 83 per cent with radiotherapy alone and 89 and 87 per cent with chemoradiotherapy, a hazard ratio of 0.84 (95 per cent confidence interval 0.46 to 1.55, p=0.58). There was no difference in disease-free or overall survival. Carboplatin did not worsen the radiation toxicity, and grade 3 or 4 late toxicity was infrequent in both arms.\n\nTwo readings follow. The negative one is that carboplatin adds nothing and should not be given. The positive one is the control arm: surgery followed by radiotherapy controlled 83 per cent of these tumours locally and regionally at five years, and the first site of failure was locoregional rather than distant in all but 7 per cent. That is the benchmark the adjuvant immunotherapy trials had to beat, and it is why C-POST was designed with disease-free survival rather than local control as its endpoint.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00193895","url":"https://clinicaltrials.gov/study/NCT00193895"},{"label":"Primary report (Journal of Clinical Oncology 2018)","url":"https://doi.org/10.1200/JCO.2017.77.0941"},{"label":"Primary report on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/29537906/"}],"tags":[],"related":[],"cancers":["cutaneous-scc","skin-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":["radiotherapy-for-skin-cancer","perineural-invasion"],"trials":["c-post","avril-surgery-versus-radiotherapy-bcc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00193895","phase":"3","setting":"High-risk cutaneous squamous cell carcinoma of the head and neck after resection of gross disease: postoperative radiotherapy of 60 to 66 Gy over six to six and a half weeks, with or without weekly carboplatin at an area under the curve of 2, with freedom from locoregional relapse as the primary endpoint","sponsor":"Trans Tasman Radiation Oncology Group","result":"Freedom from locoregional relapse at five years 87 per cent with chemoradiotherapy against 83 per cent with radiotherapy alone (hazard ratio 0.84, 95 per cent confidence interval 0.46 to 1.55, p=0.58), with no difference in disease-free or overall survival.","started":"2005-04","yearReported":2018,"enrolled":321,"enrolledBasis":"registry","outcomes":[{"endpoint":"Freedom from locoregional relapse at 5 years","primary":true,"unit":"%","arms":[{"name":"Postoperative radiotherapy with weekly carboplatin","n":153,"value":87,"note":"95 per cent confidence interval 81 to 93"},{"name":"Postoperative radiotherapy alone","n":157,"value":83,"note":"95 per cent confidence interval 77 to 90"}],"hr":0.84,"ci":[0.46,1.55],"p":"0.58","source":"https://doi.org/10.1200/jco.2017.77.0941"},{"endpoint":"Freedom from locoregional relapse at 2 years","unit":"%","arms":[{"name":"Postoperative radiotherapy with weekly carboplatin","n":153,"value":89,"note":"95 per cent confidence interval 84 to 94"},{"name":"Postoperative radiotherapy alone","n":157,"value":88,"note":"95 per cent confidence interval 83 to 93"}],"source":"https://doi.org/10.1200/jco.2017.77.0941"}],"replication":"No second randomised trial of chemoradiotherapy in cutaneous squamous cell carcinoma has been run. The adjuvant question moved to immunotherapy instead, and C-POST answered it."},{"id":"trog-99-03","kind":"trial","name":"TROG 99.03","aka":["TROG 99.03","ALLG NHLLOW5","Radiotherapy with or without systemic therapy in early follicular lymphoma"],"tldr":"Radiotherapy can cure early follicular lymphoma, but most relapses happen outside the treated area. Adding a short course of drug treatment afterwards halved that risk.","summary":"Involved-field radiotherapy alone cures a proportion of stage I and II follicular lymphoma, and the relapses that follow are mostly outside the radiation field. TROG 99.03, run across Australia and New Zealand, tested whether adding systemic treatment after radiotherapy prevents them. 150 patients were randomised between 30 Gy of involved-field radiotherapy alone and the same radiotherapy followed by six cycles of cyclophosphamide, vincristine and prednisolone; from 2006 rituximab was added to the chemotherapy arm, so 31 of the 75 patients in that arm received R-CVP and 44 received CVP.\n\nAt a median follow-up of 9.6 years, progression-free survival favoured the combined arm (hazard ratio 0.57, 95 per cent confidence interval 0.34 to 0.95, p = 0.033), with ten-year rates of 59 per cent against 41 per cent. The patients who received R-CVP did markedly better than the contemporaneous radiotherapy-only patients (hazard ratio 0.26, 0.07 to 0.97, p = 0.045). Overall survival was not significantly different, at 95 per cent against 87 per cent at ten years (p = 0.40). Histological transformation occurred in four patients in the combined arm and ten in the radiotherapy arm.\n\nOnly 48 per cent of patients were staged with positron emission tomography, which is the trial's main limitation: modern staging reclassifies a proportion of apparent stage I disease as advanced, and that is where some of the radiotherapy-alone failures came from.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT00115700","url":"https://clinicaltrials.gov/study/NCT00115700"},{"label":"Journal of Clinical Oncology 2018","url":"https://doi.org/10.1200/JCO.2018.77.9892"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["follicular-lymphoma","non-hodgkin-lymphoma"],"sections":["radiation","chemotherapy"],"technologies":["radiotherapy","pet-ct","monoclonal-antibody"],"targets":[],"drugs":["cyclophosphamide","vincristine","prednisone","rituximab"],"companies":[],"institutions":[],"pathways":[],"terms":["lugano-classification"],"trials":["fortplus"],"people":[],"bottlenecks":["b-rare-cancers","b-surgery-radiation-innovation"],"keyPapers":["paper-trog-99-03-radiotherapy-systemic-therapy-early-follicular-jco-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00115700","phase":"3","setting":"Stage I or II low-grade follicular lymphoma: involved-field radiotherapy alone against radiotherapy followed by six cycles of CVP, with rituximab added from 2006","sponsor":"Trans Tasman Radiation Oncology Group","result":"Ten-year progression-free survival 59 against 41 per cent when systemic therapy followed radiotherapy (hazard ratio 0.57, p = 0.033), with no significant overall survival difference.","started":"2000-02","startedType":"actual","yearReported":2018,"enrolled":150,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 10 years","primary":true,"unit":"%","arms":[{"name":"Radiotherapy then CVP or R-CVP","n":75,"value":59},{"name":"Radiotherapy alone","n":75,"value":41}],"hr":0.57,"ci":[0.34,0.95],"p":"0.033","source":"https://doi.org/10.1200/JCO.2018.77.9892"},{"endpoint":"Overall survival at 10 years","unit":"%","arms":[{"name":"Radiotherapy then CVP or R-CVP","value":95},{"name":"Radiotherapy alone","value":87}],"p":"0.40"}],"replication":"Consistent with the German MIR study of rituximab with radiotherapy; the FORTplus trial is testing the radiotherapy dose question alongside it."},{"id":"nct06851663","kind":"trial","name":"Trop2-targeted immunoPET Imaging of Solid Tumors","aka":[],"tldr":"A phase 2/3 trial in lung cancer, run by RenJi Hospital, now recruiting.","summary":"Trop2-targeted immunoPET Imaging of Solid Tumors is a phase 2/3, interventional study registered as NCT06851663 by RenJi Hospital, with a registry enrolment figure of 400 participants, started 2024-12-23 and due to reach its primary completion in 2027-12. Interventions recorded: [68Ga]Ga-NOTA-T4; [68Ga]Ga-NOTA-RT4; [18F]F-RESCA-T4; [18F]F-RESCA-RT4. Conditions listed: Solid Tumor; Solid Carcinoma; Uroepithelial Carcinoma; Bladder Cancer; Prostate Cancer; Lung Cancer; Nasopharyngeal Cancer; Liver Cancer; Cholangiocarcinoma; Ovarian Cancer; Cervical Cancer; Endometrial Cancer; Thyroid Cancer; Head and Neck Cancer. Primary outcome: Biodistribution-Standardized uptake value (SUV) of normal tissues and organs.; SUV of tumors; Radiation dosimetry of tissues/organs. Lung eligibility wording from the registry: \"* Histologically confirmed diagnosis of solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) or suspected solid t\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06851663","url":"https://clinicaltrials.gov/study/NCT06851663"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06851663","phase":"2/3","setting":"Trop2-targeted immunoPET Imaging of Solid Tumors","sponsor":"RenJi Hospital","started":"2024-12-23","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"trophimmun","kind":"trial","name":"TROPHIMMUN","aka":["69HCL16_0123"],"tldr":"TROPHIMMUN was the first immunotherapy trial in gestational trophoblastic disease, a rare tumour that arises from a pregnancy; the PD-L1 antibody avelumab cured about half of the women whose disease had stopped responding to single-drug chemotherapy, with mild side effects and a healthy pregnancy afterwards in one patient.","summary":"TROPHIMMUN was a French single-arm phase 2 trial at the Hospices Civils de Lyon in women with gestational trophoblastic neoplasia resistant to chemotherapy, treated with avelumab every two weeks until hCG normalised and for three cycles beyond. Cohort A enrolled 15 women resistant to single-agent methotrexate or actinomycin D; cohort B enrolled women resistant to combination chemotherapy. The primary endpoint was the rate of hCG normalisation.\n\nIn cohort A, eight of 15 women (53 percent) reached normal hCG after a median of nine cycles and none relapsed, with grade 1 to 2 fatigue, nausea and infusion reactions the main toxicities and one patient going on to a healthy pregnancy; those who did not respond were cured with actinomycin D or combination chemotherapy and surgery. Cohort B, reported in 2023, showed little activity after combination chemotherapy failure. The corpus's low-risk gestational trophoblastic neoplasia page cites TROPHIMMUN for avelumab as a chemotherapy-sparing option.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03135769","url":"https://clinicaltrials.gov/study/NCT03135769"}],"tags":["soc-trials"],"related":[],"cancers":["low-risk-gtn","gestational-trophoblastic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["avelumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-trophimmun-avelumab-chemoresistant-gtn-you-jco-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03135769","phase":"2","setting":"Gestational trophoblastic neoplasia resistant to chemotherapy: the PD-L1 antibody avelumab 10 mg/kg every two weeks in two cohorts, after single-agent methotrexate or actinomycin D failure (cohort A) and after combination chemotherapy failure (cohort B), with normalisation of hCG as the primary endpoint","sponsor":"Hospices Civils de Lyon","result":"hCG normalisation in 8 of 15 women (53 percent) with single-agent chemotherapy-resistant disease, none of whom relapsed; grade 1 to 2 adverse events in 93 percent and no treatment-related grade 3 events.","started":"2017-02-21","startedType":"actual","yearReported":2020,"enrolled":24,"enrolledBasis":"registry","outcomes":[{"endpoint":"hCG normalisation, cohort A (resistance to single-agent chemotherapy)","primary":true,"unit":"%","arms":[{"name":"Avelumab 10 mg/kg every 2 weeks","n":15,"value":53.3,"note":"8 of 15 after a median of 9 cycles; no relapse at a median follow-up of 25 months"}],"source":"https://doi.org/10.1200/JCO.20.00803"},{"endpoint":"Treatment-related grade 1 to 2 adverse events, cohort A","unit":"%","arms":[{"name":"Avelumab 10 mg/kg every 2 weeks","n":15,"value":93,"note":"Fatigue 33.3%, nausea or vomiting 33.3%, infusion reaction 26.7%"}],"source":"https://doi.org/10.1200/JCO.20.00803"}]},{"id":"tropic","kind":"trial","name":"TROPIC","aka":["TROPIC","EFC6193"],"tldr":"Showed that a second taxane still works after docetaxel has stopped working, adding about two and a half months of life, and that it suppresses the bone marrow hard.","summary":"TROPIC randomised 755 men whose prostate cancer had progressed during or after docetaxel to cabazitaxel 25 mg/m2 (378) or mitoxantrone 12 mg/m2 (377) every 3 weeks, both with prednisone 10 mg daily.\n\nAt the final analysis, median survival was 15.1 months (95 percent confidence interval 14.1 to 16.3) with cabazitaxel and 12.7 months (11.6 to 13.7) with mitoxantrone, hazard ratio for death 0.70 (0.59 to 0.83, p<0.0001). Median progression-free survival was 2.8 months (2.4 to 3.0) against 1.4 months (1.4 to 1.7), hazard ratio 0.74 (0.64 to 0.86, p<0.0001).\n\nThe haematological cost is what determines who can have it. Grade 3 or higher neutropenia occurred in 303 of 378 men on cabazitaxel (82 percent) against 215 of 377 (58 percent), and febrile neutropenia in 28 (8 percent) against five (1 percent). Grade 3 or higher diarrhoea occurred in 23 (6 percent) against one.\n\nIn England NICE TA391 recommends cabazitaxel with prednisone or prednisolone after docetaxel only if the man has an ECOG performance status of 0 or 1, has had at least 225 mg/m2 of docetaxel, and stops at progression or after a maximum of 10 cycles, with the commercial arrangement in place.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00417079","url":"https://clinicaltrials.gov/study/NCT00417079"},{"label":"TROPIC (Lancet 2010)","url":"https://doi.org/10.1016/S0140-6736(10)61389-X"},{"label":"NICE TA391: cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel","url":"https://www.nice.org.uk/guidance/ta391"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cabazitaxel","mitoxantrone","prednisone"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":["castration-resistance","mcrpc-mhspc"],"trials":["proselica","firstana","card","tax-327"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00417079","phase":"3","setting":"Metastatic castration-resistant prostate cancer progressing during or after a docetaxel-containing regimen: prednisone 10 mg daily for everyone, with cabazitaxel 25 mg/m2 or mitoxantrone 12 mg/m2 intravenously every 3 weeks, with overall survival as the primary endpoint","sponsor":"Sanofi-Aventis","result":"Median survival 15.1 against 12.7 months (hazard ratio 0.70, 95 percent confidence interval 0.59 to 0.83); grade 3 or higher neutropenia in 82 percent and febrile neutropenia in 8 percent.","started":"2007-01","yearReported":2010,"enrolled":755,"enrolledBasis":"randomised","enrolledNote":"755 men were allocated to treatment and all were included in the intention-to-treat analysis.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Cabazitaxel 25 mg/m2 with prednisone","n":378,"value":15.1},{"name":"Mitoxantrone with prednisone","n":377,"value":12.7}],"hr":0.7,"ci":[0.59,0.83],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(10)61389-X"},{"endpoint":"Progression-free survival (median)","unit":"months","arms":[{"name":"Cabazitaxel 25 mg/m2 with prednisone","n":378,"value":2.8},{"name":"Mitoxantrone with prednisone","n":377,"value":1.4}],"hr":0.74,"ci":[0.64,0.86],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(10)61389-X"},{"endpoint":"Grade 3 or higher neutropenia","unit":"%","arms":[{"name":"Cabazitaxel 25 mg/m2 with prednisone","n":378,"value":82},{"name":"Mitoxantrone with prednisone","n":377,"value":58}],"source":"https://doi.org/10.1016/S0140-6736(10)61389-X"}],"replication":"PROSELICA confirmed the efficacy at a reduced 20 mg/m2 dose, and CARD confirmed cabazitaxel beats switching to a second androgen receptor pathway inhibitor."},{"id":"tropics-02","kind":"trial","name":"TROPiCS-02","aka":[],"tldr":"The TROP2 ADC extended survival by about three months in heavily pretreated hormone-positive breast cancer.","summary":"TROPiCS-02, trial NCT03901339 sponsored by Gilead and reported in 2022, showed that the TROP2 antibody-drug conjugate sacituzumab govitecan extends survival in heavily pretreated HR-positive, HER2-negative metastatic breast cancer. It randomised 543 women who had received endocrine therapy, a CDK4/6 inhibitor and two to four chemotherapies to sacituzumab govitecan or chemotherapy, met its primary progression-free survival endpoint and showed an overall survival benefit of a few months, leading to approval in February 2023 and establishing antibody-drug conjugates in this disease after chemotherapy. OnCo links it to TROP2 as a target, sacituzumab govitecan and Hope S. Rugo. Whether TROP2 ADCs should move earlier, before chemotherapy, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03901339","url":"https://clinicaltrials.gov/study/NCT03901339"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["trop2"],"drugs":["sacituzumab-govitecan"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["hope-rugo"],"bottlenecks":[],"keyPapers":["paper-tropics-02-lancet-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03901339","phase":"3","setting":"HR+/HER2- metastatic breast cancer after endocrine therapy, CDK4/6, and 2-4 chemotherapies: sacituzumab govitecan vs chemotherapy","sponsor":"Gilead","result":"OS 14.4 vs 11.2 months, HR 0.79.","started":"2019-05-08","startedType":"actual","yearReported":2022,"enrolled":543,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Sacituzumab govitecan","n":272,"value":5.5},{"name":"Chemotherapy","n":271,"value":4}],"hr":0.66,"ci":[0.53,0.83],"p":"0.0003","source":"https://ascopubs.org/doi/10.1200/JCO.22.01002"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Sacituzumab govitecan","value":14.4},{"name":"Chemotherapy","value":11.2}],"hr":0.79,"ci":[0.65,0.96],"p":"0.02","source":"https://doi.org/10.1200/JCO.22.01002"}],"replication":"TROPION-Breast01 (Dato-DXd) replicated the PFS effect of a TROP2 ADC in this population but not OS."},{"id":"tropion-breast01","kind":"trial","name":"TROPION-Breast01","aka":[],"tldr":"The trial that got Datroway approved in hormone-positive breast cancer, though it did not extend overall survival.","summary":"TROPION-Breast01, trial NCT05104866 sponsored by AstraZeneca and Daiichi Sankyo and reported in 2023, is the trial that got datopotamab deruxtecan approved in HR-positive, HER2-negative metastatic breast cancer after endocrine therapy and one or two chemotherapies, though it did not extend overall survival. It randomised 732 patients to datopotamab deruxtecan or chemotherapy, met its primary progression-free survival endpoint with a higher response rate, but overall survival, also a primary endpoint, was no different, and the US approval in January 2025 rested on progression alone. OnCo links it to HR-positive breast cancer, datopotamab deruxtecan, Aditya Bardia, Sara M. Tolaney, the TROP2 ADC roadmap and the TROPION-Breast01 paper on why a progression win did not translate to survival. Why the two TROP2 ADCs diverged on survival is the open question.","status":"mixed","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05104866","url":"https://clinicaltrials.gov/study/NCT05104866"}],"tags":[],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["aditya-bardia","sara-tolaney"],"bottlenecks":[],"keyPapers":["paper-tropion-breast01-china-cohort-esmo-open-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05104866","phase":"3","setting":"HR+/HER2- metastatic breast cancer after endocrine and 1-2 chemotherapies: Dato-DXd vs chemotherapy","sponsor":"AstraZeneca / Daiichi Sankyo","result":"PFS HR 0.63; OS HR 1.01.","started":"2021-10-18","startedType":"actual","yearReported":2023,"enrolled":732,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Datopotamab deruxtecan","n":365,"value":6.9},{"name":"Chemotherapy (ICC)","n":367,"value":4.9}],"hr":0.63,"ci":[0.52,0.76],"p":"<0.0001","source":"https://ascopubs.org/doi/10.1200/JCO.24.00920"},{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Datopotamab deruxtecan","value":18.6,"note":"Not significant"},{"name":"Chemotherapy (ICC)","value":18.3}],"hr":1.01,"ci":[0.83,1.22],"source":"https://clinicaltrials.gov/study/NCT05104866"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Datopotamab deruxtecan","value":36.4},{"name":"Chemotherapy (ICC)","value":22.9}],"source":"https://doi.org/10.1200/JCO.24.00920"}],"replication":"PFS-only benefit; the OS result did not replicate the PFS signal. The HR+ population is also served by TROPiCS-02 (sacituzumab), which did show an OS benefit."},{"id":"tropion-breast02","kind":"trial","name":"TROPION-Breast02","aka":[],"tldr":"The first trial to show an overall survival benefit for a first-line ADC in triple-negative breast cancer.","summary":"TROPION-Breast02, trial NCT05374512 sponsored by AstraZeneca and Daiichi Sankyo and reported at ESMO 2025 and ESMO Breast 2026, was the first trial to show an overall survival benefit for a first-line antibody-drug conjugate in metastatic triple-negative breast cancer, in patients who cannot receive PD-1 or PD-L1 inhibitors. It randomised 644 patients to datopotamab deruxtecan or chemotherapy, met both dual primary endpoints of progression-free and overall survival, and led to FDA approval in the second quarter of 2026. OnCo links it to triple-negative breast cancer, datopotamab deruxtecan, Rebecca Dent, the TNBC and TROP2 ADC roadmaps and the TROPION-Breast01 paper. The comparison with sacituzumab is indirect, so choice depends on side-effect profiles, stomatitis and eye effects against neutropenia and diarrhoea, which is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05374512","url":"https://clinicaltrials.gov/study/NCT05374512"},{"label":"LBBC ASCO 2026 summary","url":"https://www.lbbc.org/news/pivotal-progress-in-tnbc-asco-2026"},{"label":"TROPION-Breast02 (Annals of Oncology 2026)","url":"https://doi.org/10.1016/j.annonc.2026.03.008"},{"label":"Datroway label (openFDA): TROPION-Breast02 study section","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22DATROWAY%22"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["rebecca-dent"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Primary paper (Annals of Oncology 2026): 644 patients randomised 1 to 1 between May 2022 and June 2024, 90 percent PD-L1-negative, 10 percent with stable brain metastases; progression-free survival 10.8 versus 5.6 months (hazard ratio 0.57), overall survival 23.7 versus 18.7 months (hazard ratio 0.79, p 0.029); treatment-related grade 3 or higher adverse events 33 versus 29 percent, no treatment-related deaths. The chemotherapy arm was nab-paclitaxel 54 percent, paclitaxel 28 percent, eribulin 11 percent, carboplatin 4.7 percent, capecitabine 2.2 percent (Datroway label). UK sites (registry, 9): Bristol, Cardiff, Edinburgh, London (3), Northampton, Nottingham, Warwick. NICE appraisal GID-TA11535 awaiting development; no EU triple-negative indication yet."],"nct":"NCT05374512","phase":"3","setting":"First-line metastatic TNBC, not candidates for PD-1/PD-L1: Dato-DXd vs chemotherapy","sponsor":"AstraZeneca / Daiichi Sankyo","result":"OS 23.7 vs 18.7 months; PFS also improved.","started":"2022-05-16","startedType":"actual","yearReported":2025,"enrolled":644,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Datopotamab deruxtecan","n":323,"value":10.8},{"name":"Chemotherapy (ICC)","n":321,"value":5.6}],"hr":0.57,"ci":[0.47,0.69],"p":"<0.0001","source":"https://www.annalsofoncology.org/article/S0923-7534(26)00130-4/fulltext"},{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Datopotamab deruxtecan","value":23.7},{"name":"Chemotherapy (ICC)","value":18.7}],"hr":0.79,"ci":[0.64,0.98],"p":"0.0291","source":"https://www.astrazeneca.com/media-centre/press-releases/2025/datroway-demonstrated-an-unprecedented-median-overall-survival-improvement-of-five-months-vs-chemotherapy-as-1st-line-treatment-for-patients-with-metastatic-triple-negative-breast-cancer-for-whom-immunotherapy-was-not-an-option-in-tropion-breast02.html"}],"replication":"Consistent with ASCENT-03 (sacituzumab govitecan, same population, PFS HR 0.62), supporting a TROP2-ADC class effect in first-line PD-1-ineligible TNBC."},{"id":"tropion-breast03","kind":"trial","name":"TROPION-Breast03","aka":[],"tldr":"TROPION-Breast03 is the Dato-DXd counterpart to ASCENT-05: an ADC, with or without immunotherapy, for triple-negative patients with leftover cancer at surgery.","summary":"TROPION-Breast03, trial NCT05629585 sponsored by AstraZeneca and Daiichi Sankyo, is the datopotamab deruxtecan counterpart to ASCENT-05: an antibody-drug conjugate, with or without immunotherapy, for patients with stage I to III triple-negative breast cancer left with residual invasive disease after neoadjuvant therapy. It is a three-arm phase 3 of 1,075 patients randomised two to one to two to datopotamab deruxtecan for eight cycles plus durvalumab for nine, datopotamab deruxtecan alone, or investigator's choice of capecitabine, pembrolizumab or both, with invasive disease-free survival as the primary endpoint and estimated primary completion on 20 September 2027. It is ongoing with no results, and whether an ADC after residual disease improves on the KATHERINE-style switch strategy in TNBC is the question it will answer.","status":"active","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT05629585","url":"https://clinicaltrials.gov/study/NCT05629585"},{"label":"TROPION-Breast03 design (Ther Adv Med Oncol 2024)","url":"https://journals.sagepub.com/doi/10.1177/17588359241248336"},{"label":"TROPION-Breast03 design","url":"https://doi.org/10.1177/17588359241248336"}],"tags":[],"related":["idea-post-neoadjuvant-adc","ascent-05"],"cancers":["tnbc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan","durvalumab","pembrolizumab"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":["rcb","efs"],"trials":["keynote-522"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Design paper (Therapeutic Advances in Medical Oncology 2024): stage I to III triple-negative disease with residual invasive disease at surgery, randomised 2 to 1 to 2 to datopotamab deruxtecan 6 mg/kg for eight cycles with durvalumab for nine, datopotamab alone, or investigator's choice of capecitabine, pembrolizumab or both; primary endpoint invasive disease-free survival for the combination against investigator's choice; registry 1,174 actual, primary completion September 2027. UK sites (registry, 12): Cambridge, Cardiff, Edinburgh, Greater London, London (2), Londonderry, Manchester, Newcastle upon Tyne, Portsmouth, Surrey, Taunton. NICE appraisal GID-TA11835 awaiting development."],"nct":"NCT05629585","phase":"3","setting":"Stage I to III TNBC with residual invasive disease after neoadjuvant therapy: adjuvant Dato-DXd ± durvalumab vs investigator's choice (capecitabine, pembrolizumab, or both)","sponsor":"AstraZeneca / Daiichi Sankyo","started":"2022-11-28","startedType":"actual","enrolled":1174,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing; no results."},{"id":"tropion-breast05","kind":"trial","name":"TROPION-Breast05","aka":[],"tldr":"Tests whether Dato-DXd plus a PD-L1 blocker beats today's immunotherapy-chemotherapy standard.","summary":"TROPION-Breast05, trial NCT06103864 sponsored by AstraZeneca and Daiichi Sankyo, tests whether datopotamab deruxtecan with or without the PD-L1 antibody durvalumab beats today's pembrolizumab plus chemotherapy standard in first-line PD-L1-positive metastatic triple-negative breast cancer. It is a three-arm phase 3 of 625 patients with readout expected in 2026 to 2027, and together with ASCENT-04 it will define ADC plus immunotherapy as first-line therapy. OnCo links it to triple-negative breast cancer, datopotamab deruxtecan, durvalumab, pembrolizumab, the ADC plus checkpoint inhibitor pairing and the TNBC and TROP2 ADC roadmaps. It is ongoing with no results, and whether the ADC alone is enough or immunotherapy must be added is the question its three-arm design will answer.","status":"recruiting","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT06103864","url":"https://clinicaltrials.gov/study/NCT06103864"},{"label":"TROPION-Breast05 design","url":"https://doi.org/10.1177/17588359251327992"}],"tags":[],"related":[],"cancers":["tnbc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan","durvalumab","pembrolizumab"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Design paper (Therapeutic Advances in Medical Oncology 2025): 625 patients with PD-L1-high (CPS 10 or more) disease randomised 1 to 1 to datopotamab deruxtecan 6 mg/kg with durvalumab 1,120 mg every 3 weeks or investigator's choice chemotherapy with pembrolizumab, with a third datopotamab-alone arm in selected countries; primary endpoint progression-free survival by blinded review; primary completion July 2027. UK sites (registry, 10): Cardiff, Chelsea, Leicester, Liverpool, London (2), Oxford, Surrey, Sutton, Taunton."],"nct":"NCT06103864","phase":"3","setting":"First-line PD-L1+ metastatic TNBC: Dato-DXd ± durvalumab vs pembrolizumab + chemotherapy","sponsor":"AstraZeneca / Daiichi Sankyo","started":"2023-11-23","startedType":"actual","enrolled":625,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing; no results."},{"id":"tropion-lung01","kind":"trial","name":"TROPION-Lung01","aka":[],"tldr":"A TROP2 ADC helped in non-squamous lung cancer but not squamous, and the overall survival result fell short.","summary":"TROPION-Lung01, trial NCT04656652 sponsored by AstraZeneca and Daiichi Sankyo and reported in 2023, found that the TROP2 antibody-drug conjugate datopotamab deruxtecan helped in previously treated non-squamous non-small-cell lung cancer but not in squamous disease, and that the overall survival result fell short. It randomised 604 patients to datopotamab deruxtecan or docetaxel, met its primary progression-free survival endpoint with a modest effect driven by the non-squamous subgroup, while overall survival, also a primary endpoint, was not significantly different. It led to a narrowed EGFR-mutant approval based on TROPION-Lung05 rather than an all-comers indication, and whether TROP2 ADCs have a place in lung cancer without a driver mutation is the open question.","status":"mixed","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT04656652","url":"https://clinicaltrials.gov/study/NCT04656652"}],"tags":[],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["benjamin-besse"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04656652","phase":"3","setting":"Previously treated advanced NSCLC: Dato-DXd vs docetaxel","sponsor":"AstraZeneca / Daiichi Sankyo","result":"PFS HR 0.75; OS HR 0.94.","started":"2020-12-21","startedType":"actual","yearReported":2023,"enrolled":605,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Datopotamab deruxtecan","n":299,"value":4.4},{"name":"Docetaxel","n":305,"value":3.7}],"hr":0.75,"ci":[0.62,0.91],"p":"0.004","source":"https://ascopubs.org/doi/10.1200/JCO.24.01544"},{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Datopotamab deruxtecan","value":12.9,"note":"Not significant"},{"name":"Docetaxel","value":11.8}],"hr":0.94,"ci":[0.78,1.14],"source":"https://ascopubs.org/doi/10.1200/JCO.24.01544"},{"endpoint":"Progression-free survival, non-squamous","unit":"months","arms":[{"name":"Datopotamab deruxtecan","value":5.5},{"name":"Docetaxel","value":3.6}],"hr":0.63,"ci":[0.51,0.79],"source":"https://ascopubs.org/doi/10.1200/JCO.24.01544"}],"replication":"Mixed result; the approval that followed was narrowed to EGFR-mutant NSCLC on the basis of TROPION-Lung05 (single-arm), not this trial."},{"id":"tropion-lung05","kind":"trial","name":"TROPION-Lung05","aka":[],"tldr":"The study that got Datroway approved for EGFR-mutant lung cancer after other treatments fail.","summary":"TROPION-Lung05, trial NCT04484142 sponsored by AstraZeneca and Daiichi Sankyo and reported in 2023, is the phase 2 study that supported approval of datopotamab deruxtecan for EGFR-mutant non-small-cell lung cancer after targeted therapy and platinum chemotherapy have failed. It enrolled 137 patients with actionable genomic alterations in a single-arm design, the objective response rate by blinded review was higher in the 78 EGFR-mutant patients than overall, and pooled with EGFR-mutant patients from TROPION-Lung01 the data supported accelerated approval in June 2025. OnCo links it to TROP2 and EGFR as targets and to TROPION-Lung01. As a single-arm phase 2 it cannot show that the drug improves survival over the alternatives, and the randomised TROPION-Lung15 trial will be the confirmatory study. Datopotamab deruxtecan has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT04484142","url":"https://clinicaltrials.gov/study/NCT04484142"}],"tags":[],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["trop2","egfr"],"drugs":["datopotamab-deruxtecan"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":["tropion-lung01"],"people":[],"bottlenecks":[],"keyPapers":["paper-tropion-lung05-j-clin-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04484142","phase":"2","setting":"Actionable-genomic-alteration NSCLC after targeted therapy and platinum: datopotamab deruxtecan single arm","sponsor":"AstraZeneca / Daiichi Sankyo","result":"ORR 43.6% in EGFR-mutant disease.","started":"2021-03-30","startedType":"actual","yearReported":2023,"enrolled":137,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (BICR)","primary":true,"unit":"%","arms":[{"name":"Datopotamab deruxtecan, all","n":137,"value":35.8},{"name":"EGFR-mutant subgroup","n":78,"value":43.6}],"source":"https://ascopubs.org/doi/10.1200/JCO.24.00821"}],"replication":"Single-arm phase 2 that supported the EGFR-mutant NSCLC approval; TROPION-Lung15 (randomised) will be the confirmatory trial."},{"id":"trybeca-1","kind":"trial","name":"TRYbeCA-1","aka":[],"tldr":"Eryaspase, an enzyme carried inside red blood cells, did not lengthen survival when added to second-line chemotherapy for pancreatic cancer.","summary":"TRYbeCA-1 randomised patients with metastatic pancreatic adenocarcinoma progressing after first-line treatment to eryaspase plus gemcitabine and nab-paclitaxel or irinotecan-based chemotherapy, or chemotherapy alone. The primary endpoint of overall survival was not met when the trial reported in 2021.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03665441","url":"https://clinicaltrials.gov/study/NCT03665441"},{"label":"Hammel et al., Journal of Clinical Oncology 2025: TRYbeCA-1, eryaspase with chemotherapy as second-line treatment","url":"https://doi.org/10.1200/JCO-25-00872"}],"tags":[],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["eryaspase","gemcitabine-nab-paclitaxel"],"companies":["phaxiam"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-hammel-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03665441","phase":"3","setting":"Second-line metastatic pancreatic adenocarcinoma: eryaspase with chemotherapy versus chemotherapy alone","sponsor":"Erytech Pharma","result":"Primary overall survival endpoint not met.","started":"2018-09-15","startedType":"actual","yearReported":2021,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Eryaspase + chemotherapy","n":255,"value":7.5},{"name":"Chemotherapy alone","n":257,"value":6.7}],"hr":0.92,"ci":[0.76,1.11],"p":"0.374","source":"https://doi.org/10.1200/JCO-25-00872"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Eryaspase + chemotherapy","value":3.7},{"name":"Chemotherapy alone","value":3.4}],"hr":0.88,"ci":[0.73,1.07],"p":"0.196","source":"https://doi.org/10.1200/JCO-25-00872"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Eryaspase + chemotherapy","value":16.1},{"name":"Chemotherapy alone","value":12.5}],"source":"https://doi.org/10.1200/JCO-25-00872"}]},{"id":"nct04969315","kind":"trial","name":"TT-4 and TT-10 as Single Agents and in Combination in Subjects With Advanced Selected Solid Tumors and Pleural Mesothelioma","aka":[],"tldr":"A phase 1/2 trial of TT-10 in renal cell carcinoma, prostate cancer, non-small-cell lung cancer and mesothelioma, run by Portage Biotech, now recruiting.","summary":"TT-4 and TT-10 as Single Agents and in Combination in Subjects With Advanced Selected Solid Tumors and Pleural Mesothelioma is a phase 1/2 interventional study registered as NCT04969315 by Portage Biotech, with 35 participants planned, started 2023-06-23 and due to reach its primary completion in 2028-12-01. Interventions recorded: TT-10 and TT-4.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04969315","url":"https://clinicaltrials.gov/study/NCT04969315"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc","prostate","nsclc","mesothelioma","pleural-mesothelioma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04969315","phase":"1/2","setting":"A Phase 1/1b, Open-Label, First-in-Human Multicenter Study to Assess the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Pharmacodynamics of Oral TT-10 (an Adenosine 2A Receptor Antagonist), and TT-4 Diacid (an Adenosine 2B Receptor Antagonist), as Single Agents and in Combination in Participants With Advanced Selected Solid Tumors","sponsor":"Portage Biotech","started":"2023-06-23","startedType":"actual","enrolled":35,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07284277","kind":"trial","name":"TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)","aka":["NOVOFFOX"],"tldr":"A phase 1/2 trial in pancreatic cancer, run by Clinica Universidad de Navarra, Universidad de Navarra, now recruiting.","summary":"TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC) is a phase 1/2, interventional study registered as NCT07284277 by Clinica Universidad de Navarra, Universidad de Navarra, with a registry enrolment figure of 30 participants, started 2025-10-14 and due to reach its primary completion in 2027-03. Interventions recorded: TTFields concomitant with modFOLFIRINOX. Conditions listed: Pancreatic Adenocarcinoma Metastatic; Pancreatic Ductal Adenocarcinoma. Primary outcome: Toxicity profile in patients with mPDAC treated at 1L with TTFields concomitantly with modFOLFIRINOX. Pancreatic eligibility wording from the registry: \"Histological/cytological diagnosis of pancreatic adenocarcinoma\". Sites: Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07284277","url":"https://clinicaltrials.gov/study/NCT07284277"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["ttfields"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07284277","phase":"1/2","setting":"Phase Ib-II, Non-randomized, Open-label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With modFOLFIRINOX for Front-line Treatment of Metastatic Pancreatic Adenocarcinoma (NOVOFFOX)","sponsor":"Clinica Universidad de Navarra, Universidad de Navarra","started":"2025-10-14","startedType":"actual","enrolled":30,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04430738","kind":"trial","name":"Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers","aka":[],"tldr":"A phase 2 trial of Tucatinib, Trastuzumab, CAPOX in gallbladder cancer, run by Seagen, a wholly owned subsidiary of Pfizer, active and no longer recruiting.","summary":"Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers is a phase 2 interventional study registered as NCT04430738 by Seagen, a wholly owned subsidiary of Pfizer, with 40 participants enrolled, started 2020-09-15 and due to reach its primary completion in 2024-07-31. Interventions recorded: tucatinib, trastuzumab, oxaliplatin, leucovorin, fluorouracil. Conditions listed: Colorectal Carcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Esophageal Adenocarcinoma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04430738","url":"https://clinicaltrials.gov/study/NCT04430738"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gallbladder"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["tucatinib","trastuzumab","capox","flot","fluorouracil","capecitabine"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04430738","phase":"2","setting":"A Phase 1b/2 Dose Escalation and Expansion Study of Tucatinib in Combination With Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers","sponsor":"Seagen, a wholly owned subsidiary of Pfizer","started":"2020-09-15","startedType":"actual","yearReported":2025,"enrolled":40,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Renal Dose-Limiting Toxicities (DLTs): Phase 1b (Cohort 1A and 1B)","primary":true,"unit":"participants","arms":[{"name":"Cohort 1A","n":3,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2025-09-09), not from a publication"},{"name":"Cohort 1B","n":8,"value":1}],"source":"https://clinicaltrials.gov/study/NCT04430738?tab=results"}]},{"id":"nct05458674","kind":"trial","name":"Tucatinib+Trastuzumab+Eribulin in HER2+ MBC","aka":[],"tldr":"A phase 2 trial of Tucatinib, Eribulin and Trastuzumab in advanced solid tumours, run by Criterium, Inc., active and no longer recruiting.","summary":"Tucatinib+Trastuzumab+Eribulin in HER2+ MBC is a phase 2 interventional study registered as NCT05458674 by Criterium, Inc., with 17 participants enrolled, started 2024-01-30 and due to reach its primary completion in 2027-06-01. Interventions recorded: Tucatinib, Eribulin and Trastuzumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05458674","url":"https://clinicaltrials.gov/study/NCT05458674"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","her2-tyrosine-kinase-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["tucatinib","eribulin","trastuzumab"],"companies":["criterium"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05458674","phase":"2","setting":"A Phase II Study of the Safety, Tolerability and Antitumor Activity of Tucatinib in Combination With Eribulin and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer","sponsor":"Criterium, Inc.","started":"2024-01-30","startedType":"actual","enrolled":17,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06947967","kind":"trial","name":"Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype","aka":["SWIFT 02"],"tldr":"A phase 3 trial of Cyclophosphamide, Doxorubicin, Prednisone and Vincristine in non-Hodgkin lymphoma, run by Chipscreen Biosciences, Ltd., now recruiting.","summary":"Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype is a phase 3 interventional study registered as NCT06947967 by Chipscreen Biosciences, Ltd., with 224 participants planned, started 2025-08-12 and due to reach its primary completion in 2032-12. Interventions recorded: CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone), Tucidinostat and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06947967","url":"https://clinicaltrials.gov/study/NCT06947967"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["non-hodgkin-lymphoma","peripheral-t-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["cyclophosphamide","doxorubicin","prednisone","vincristine"],"companies":["chipscreen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06947967","phase":"3","setting":"A Phase III, Randomised, Double-blind, Placebo-controlled, Multicenter Study of Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype (SWIFT 02)","sponsor":"Chipscreen Biosciences, Ltd.","started":"2025-08-12","startedType":"actual","enrolled":224,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07190300","kind":"trial","name":"TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in ","aka":["TulmiSTAR-02"],"tldr":"A phase 1/2 trial of Darolutamide, Abiraterone acetate in prostate cancer, run by Novartis Pharmaceuticals, now recruiting.","summary":"TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) is a phase 1/2 interventional study registered as NCT07190300 by Novartis Pharmaceuticals, with 181 participants planned, started 2026-01-13 and due to reach its primary completion in 2032-08-02. Interventions recorded: Tulmimetostat, Darolutamide, Abiraterone. Conditions listed: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07190300","url":"https://clinicaltrials.gov/study/NCT07190300"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["darolutamide","abiraterone"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07190300","phase":"1/2","setting":"TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate Cancer","sponsor":"Novartis Pharmaceuticals","started":"2026-01-13","startedType":"actual","enrolled":181,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06949098","kind":"trial","name":"Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Hebei Medical University Fourth Hospital, now recruiting.","summary":"Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low Rectal Cancer is a phase 2, interventional study registered as NCT06949098 by Hebei Medical University Fourth Hospital, with a registry enrolment figure of 60 participants, started 2025-05-15 and due to reach its primary completion in 2032-03. Interventions recorded: Local Tumor Resection; Radiotherapy; Chemotherapy. Conditions listed: Rectal Cancer Stage I. Primary outcome: 5-year DFS Rate. Colorectal eligibility wording from the registry: \"Biopsy-proven rectal adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06949098","url":"https://clinicaltrials.gov/study/NCT06949098"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06949098","phase":"2","setting":"An Exploratory Study of Local Resection Combined With Chemoradiotherapy in Patients With Low/Ultra-low Early-stage Rectal Cancer With a Strong Desire to Preserve the Anus","sponsor":"Hebei Medical University Fourth Hospital","started":"2025-05-15","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03977233","kind":"trial","name":"Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 2 trial of cAPOX (capecitabine, oxaliplatin), fLOT (5-FU, leucovorin, oxaliplatin, docetaxel), irinotecan (and liposomal irinotecan) and fluorouracil (5-FU) in pancreatic cancer, run by UNC Lineberger Comprehensive Cancer Center, now recruiting.","summary":"Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer is a phase 2, interventional study registered as NCT03977233 by UNC Lineberger Comprehensive Cancer Center, with a registry enrolment figure of 45 participants, started 2019-06-12 and due to reach its primary completion in 2027-07. Interventions recorded: Oxaliplatin; Leucovorin; Irinotecan Hydrochloride; 5-FU. Conditions listed: Pancreatic Ductal Adenocarcinoma (PDAC); Cancer of Pancreas; Pancreatic Cancer, Adult; Pancreas Adenocarcinoma; Pancreatic Neoplasms; Pancreatic Cancer Non-resectable; Pancreatic Cancer Resectable. Primary outcome: Best disease control rate by Pancreatic ductal adenocarcinoma (PDAC) subtype. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed adenocarcinoma of the pancreas with no evidence of distant metastatic disease\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03977233","url":"https://clinicaltrials.gov/study/NCT03977233"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["capox","flot","irinotecan","fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03977233","phase":"2","setting":"Impact of Tumor and Stromal Subtypes on Efficacy of Neoadjuvant FOLFIRINOX in Subjects With Non-Metastatic Pancreatic Cancer","sponsor":"UNC Lineberger Comprehensive Cancer Center","started":"2019-06-12","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04589845","kind":"trial","name":"Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study","aka":["TAPISTRY"],"tldr":"A phase 2 trial of Entrectinib, Alectinib, Atezolizumab, Ipatasertib, Trastuzumab emtansine and Inavolisib in advanced solid tumours, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study is a phase 2 interventional study registered as NCT04589845 by Hoffmann-La Roche, with 920 participants enrolled, started 2021-01-18 and due to reach its primary completion in 2032-09-25. Interventions recorded: Entrectinib, Alectinib, Atezolizumab, Ipatasertib, Trastuzumab emtansine and Inavolisib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04589845","url":"https://clinicaltrials.gov/study/NCT04589845"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["entrectinib","alectinib","atezolizumab","ipatasertib","trastuzumab-emtansine","inavolisib","camonsertib"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04589845","phase":"2","setting":"Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial","sponsor":"Hoffmann-La Roche","started":"2021-01-18","startedType":"actual","enrolled":920,"enrolledBasis":"registry","outcomes":[]},{"id":"tumorapa","kind":"trial","name":"TUMORAPA (switching from a calcineurin inhibitor to sirolimus after a transplant skin cancer)","aka":["TUMORAPA","TUMORAPA 1"],"tldr":"A person with a transplanted kidney who has had one skin squamous cancer will usually get more. Swapping one anti-rejection drug for another roughly halved the number who got another cancer, but it made people unwell often enough that a quarter stopped the new drug.","summary":"The immunosuppression that keeps a transplanted organ alive is what lets keratinocyte cancers grow, and a transplant recipient who has had one cutaneous squamous cell carcinoma will usually go on to have several. TUMORAPA tested the obvious intervention: change the immunosuppressive drug rather than treat the cancers one at a time. One hundred and twenty kidney transplant recipients on calcineurin inhibitors who had already had at least one cutaneous squamous cell carcinoma were randomised to switch to sirolimus, a mammalian target of rapamycin inhibitor with antitumour activity, or to carry on as they were.\n\nSurvival free of cutaneous squamous cell carcinoma was significantly longer in the sirolimus group. New squamous cell carcinomas developed in 14 of 64 patients (22 per cent) on sirolimus, six of them after the drug had been withdrawn, against 22 of 56 (39 per cent) on calcineurin inhibitors, with a median time to onset of 15 against 7 months (p=0.02) and a relative risk of 0.56 (95 per cent confidence interval 0.32 to 0.98). Graft function stayed stable in both groups.\n\nThe cost is the reason this is not done automatically. There were 60 serious adverse events in the sirolimus group against 14 in the calcineurin inhibitor group, an average of 0.938 against 0.250 per patient, and 23 per cent of the sirolimus group stopped the drug because of adverse events. Twice as many serious events occurred in patients switched rapidly as in those switched gradually, which is a practical instruction rather than a statistic.\n\nThis trial and the twelve-patient phase 1 study of cemiplimab in kidney transplant recipients are, between them, almost the whole randomised and prospective evidence base for a group that has up to a hundredfold excess risk of this cancer.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00133887","url":"https://clinicaltrials.gov/study/NCT00133887"},{"label":"Primary report (New England Journal of Medicine 2012)","url":"https://doi.org/10.1056/NEJMoa1204166"},{"label":"Primary report on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/22830463/"}],"tags":[],"related":[],"cancers":["cutaneous-scc","skin-cancer"],"sections":[],"technologies":["chemoprevention"],"targets":["mtor"],"drugs":["sirolimus"],"companies":[],"institutions":[],"pathways":[],"terms":["skin-cancer-after-organ-transplant","field-cancerisation"],"trials":["cemiplimab-kidney-transplant-cscc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00133887","phase":"3","setting":"Kidney transplant recipients taking calcineurin inhibitors who had already had at least one cutaneous squamous cell carcinoma: substituting sirolimus for the calcineurin inhibitor against maintaining the existing treatment, with survival free of squamous cell carcinoma at two years as the primary endpoint","sponsor":"Hospices Civils de Lyon","result":"New cutaneous squamous cell carcinoma in 22 per cent of patients switched to sirolimus against 39 per cent continuing calcineurin inhibitors (relative risk 0.56, 95 per cent confidence interval 0.32 to 0.98), with 23 per cent stopping sirolimus for adverse events.","started":"2004-04","yearReported":2012,"enrolled":120,"enrolledBasis":"randomised","enrolledNote":"120 kidney transplant recipients were randomised, 64 to sirolimus and 56 to continued calcineurin inhibitor treatment; the ClinicalTrials.gov record NCT00133887 gives an enrolment of 77.","outcomes":[{"endpoint":"New cutaneous squamous cell carcinoma","primary":true,"unit":"%","arms":[{"name":"Switch to sirolimus","n":64,"value":22,"note":"14 of 64 patients, 6 of them after sirolimus was withdrawn; median time to onset 15 months"},{"name":"Continue calcineurin inhibitor","n":56,"value":39,"note":"22 of 56 patients; median time to onset 7 months"}],"p":"0.02","source":"https://doi.org/10.1056/nejmoa1204166"},{"endpoint":"Serious adverse events per patient","unit":"events per patient","arms":[{"name":"Switch to sirolimus","n":64,"value":0.938,"note":"60 serious adverse events; 23 per cent discontinued sirolimus"},{"name":"Continue calcineurin inhibitor","n":56,"value":0.25,"note":"14 serious adverse events"}],"source":"https://doi.org/10.1056/nejmoa1204166"}],"replication":"Retrospective and registry work has pointed the same way, and mammalian target of rapamycin inhibitor conversion is in transplant dermatology guidance, but no second randomised trial of the size of TUMORAPA has been run."},{"id":"nct04524689","kind":"trial","name":"Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC","aka":[],"tldr":"A phase 2 trial of Tusamitamab ravtansine, Pembrolizumab, Cisplatin, Carboplatin and Pemetrexed in Non-small-cell lung cancer, run by Sanofi, recorded as terminated on the registry.","summary":"Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC is a phase 2 interventional study registered as NCT04524689 by Sanofi, with 57 participants recorded, started 2020-10-26 and due to reach its primary completion in 2024-03-12. Interventions recorded: SAR408701 (Tusamitamab ravtansine), Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed. Conditions recorded: Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC).\n\nLinked to the drug Tusamitamab ravtansine because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04524689","url":"https://clinicaltrials.gov/study/NCT04524689"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["tusamitamab-ravtansine","pembrolizumab","cisplatin","carboplatin","pemetrexed"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04524689","phase":"2","setting":"Open-label, Phase 2 Study of Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)","sponsor":"Sanofi","started":"2020-10-26","startedType":"actual","yearReported":2025,"enrolled":57,"enrolledBasis":"registry","outcomes":[{"endpoint":"Doublet Cohort: Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab","n":23,"value":47.8,"note":"95% CI 26.82 to 69.41; Figures from the ClinicalTrials.gov results section (first posted 2025-03-17), not from a publication"},{"name":"Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab","n":2,"value":0,"note":"95% CI 0.00 to 84.19"}],"source":"https://clinicaltrials.gov/study/NCT04524689?tab=results"},{"endpoint":"Quadruplet Cohort: Objective Response Rate","primary":true,"unit":"%","arms":[{"name":"Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed","n":22,"value":59.1,"note":"95% CI 36.35 to 79.29; Figures from the ClinicalTrials.gov results section (first posted 2025-03-17), not from a publication"},{"name":"Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed","n":3,"value":66.7,"note":"95% CI 9.43 to 99.16"}],"source":"https://clinicaltrials.gov/study/NCT04524689?tab=results"}]},{"id":"nct04659603","kind":"trial","name":"Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors","aka":[],"tldr":"A phase 2 trial of Tusamitamab ravtansine and Gemcitabine in Breast cancer, run by Sanofi, recorded as terminated on the registry.","summary":"Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors is a phase 2 interventional study registered as NCT04659603 by Sanofi, with 50 participants recorded, started 2021-03-29 and due to reach its primary completion in 2024-02-16. Interventions recorded: tusamitamab ravtansine, Gemcitabine. Conditions recorded: Breast Cancer Metastatic, Pancreatic Carcinoma Metastatic.\n\nLinked to the drug Tusamitamab ravtansine because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04659603","url":"https://clinicaltrials.gov/study/NCT04659603"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["tusamitamab-ravtansine","gemcitabine"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04659603","phase":"2","setting":"Open-label, Multi-cohort, Phase 2 Trial, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine (SAR408701) Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors","sponsor":"Sanofi","started":"2021-03-29","startedType":"actual","yearReported":2025,"enrolled":50,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Cohort A: mBC","n":6,"value":0,"note":"95% CI 0.00 to 45.93; Figures from the ClinicalTrials.gov results section (first posted 2025-03-25), not from a publication"},{"name":"Cohort B: mPAC","n":28,"value":3.6,"note":"95% CI 0.09 to 18.35"},{"name":"Cohort C: mPAC","n":16,"value":31.3,"note":"95% CI 11.02 to 58.66"}],"source":"https://clinicaltrials.gov/study/NCT04659603?tab=results"},{"endpoint":"Progression-free Survival (PFS)","unit":"months","arms":[{"name":"Cohort A: mBC","n":6,"value":3.71,"note":"95% CI 1.314 to NA; Figures from the ClinicalTrials.gov results section (first posted 2025-03-25), not from a publication"},{"name":"Cohort B: mPAC","n":28,"value":1.87,"note":"95% CI 1.643 to 2.267"},{"name":"Cohort C: mPAC","n":16,"value":4.73,"note":"95% CI 1.873 to NA"}],"source":"https://clinicaltrials.gov/study/NCT04659603?tab=results"}]},{"id":"nct07267078","kind":"trial","name":"Tuvonralimab and Iparomlimab Based Regimens for the Neoadjuvant Treatment of Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of gemcitabine and oxaliplatin in gallbladder cancer and other biliary tract cancers, run by Peking Union Medical College Hospital, now recruiting.","summary":"Tuvonralimab and Iparomlimab Based Regimens for the Neoadjuvant Treatment of Biliary Tract Cancer is a phase 2 interventional study registered as NCT07267078 by Peking Union Medical College Hospital, with a registry enrolment figure of 45 participants, started 2025-05-25 and due to reach its primary completion in 2028-01-25. Interventions recorded: Tuvonralimab/Iparomlimab combination with GEMOX chemotherapy. Conditions listed: Biliary Tract Cancer. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07267078","url":"https://clinicaltrials.gov/study/NCT07267078"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine","oxaliplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07267078","phase":"2","setting":"Neoadjuvant Tuvonralimab and Iparomlimab With Gemcitabine-oxaliplatin for Biliary Tract Cancer","sponsor":"Peking Union Medical College Hospital","started":"2025-05-25","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"tuxedo-1","kind":"trial","name":"TUXEDO-1","aka":[],"tldr":"TUXEDO-1 was a small study that showed trastuzumab deruxtecan shrinks brain metastases in most people with HER2-positive breast cancer, overturning the assumption that large antibody-drug conjugates cannot work inside the brain.","summary":"TUXEDO-1 was a single-centre phase 2 study in Vienna of trastuzumab deruxtecan in 15 patients with HER2-positive breast cancer and active brain metastases, either untreated or progressing after local therapy, who did not need immediate local treatment. The primary endpoint was intracranial response rate.\n\nMost patients had an intracranial response and the responses were durable, with quality of life maintained. Together with the DEBBRAH study and the brain metastasis cohorts of the DESTINY-Breast trials, it established that trastuzumab deruxtecan is active in the brain and made systemic therapy a realistic option for some patients who would otherwise have had radiotherapy first.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04752059","url":"https://clinicaltrials.gov/study/NCT04752059"}],"tags":["subtype-trials"],"related":[],"cancers":["her2-positive-breast-brain-metastases","breast-her2-positive","breast-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["rupert-bartsch"],"bottlenecks":[],"keyPapers":["paper-tuxedo-1-trastuzumab-deruxtecan-brain-metastases-nat-med-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04752059","phase":"2","setting":"HER2-positive breast cancer with newly diagnosed or progressing brain metastases: single-arm trastuzumab deruxtecan","sponsor":"Medical University of Vienna","result":"Intracranial responses in most patients with active HER2-positive breast cancer brain metastases.","started":"2020-07-28","startedType":"actual","yearReported":2022,"enrolled":15,"enrolledBasis":"registry","outcomes":[{"endpoint":"Best overall intracranial response rate (RANO-BM)","primary":true,"unit":"%","arms":[{"name":"Trastuzumab deruxtecan 5.4 mg/kg","n":15,"value":73.3,"note":"95% CI 48.1 to 89.1; Simon two-stage null hypothesis <26%"}],"source":"https://doi.org/10.1038/s41591-022-01935-8"},{"endpoint":"Complete intracranial response","unit":"%","arms":[{"name":"Trastuzumab deruxtecan 5.4 mg/kg","n":15,"value":13.3}],"source":"https://doi.org/10.1038/s41591-022-01935-8"},{"endpoint":"Partial intracranial response","unit":"%","arms":[{"name":"Trastuzumab deruxtecan 5.4 mg/kg","n":15,"value":60}],"source":"https://doi.org/10.1038/s41591-022-01935-8"}]},{"id":"nct07276373","kind":"trial","name":"Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies","aka":[],"tldr":"A phase 1/2 trial of Nivolumab in advanced solid tumours, run by Corcept Therapeutics, now recruiting.","summary":"Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies is a phase 1/2 interventional study registered as NCT07276373 by Corcept Therapeutics, with 50 participants planned, started 2026-01-16 and due to reach its primary completion in 2026-09. Interventions recorded: Nenocorilant 200 mg, Nenocorilant 300 mg, Nenocorilant 400 mg and Nivolumab.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07276373","url":"https://clinicaltrials.gov/study/NCT07276373"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["corcept"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07276373","phase":"1/2","setting":"A Phase 1b/2, Open-Label, Dose-Finding and Proof of Concept Study of Nenocorilant in Combination With Anti-Programmed Cell Death/(Ligand) 1 in Patients With Advanced Solid Malignancies","sponsor":"Corcept Therapeutics","started":"2026-01-16","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct01204125","kind":"trial","name":"Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients","aka":[],"tldr":"A phase 2 trial of Paclitaxel / nab-paclitaxel and Iniparib in Breast cancer, run by Sanofi, completed.","summary":"Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients is a phase 2 interventional study registered as NCT01204125 by Sanofi, with 141 participants recorded, started 2010-09 and reaching its primary completion in 2012-10. Interventions recorded: paclitaxel, Iniparib (SAR2405550 -BSI-201). Conditions recorded: Breast Cancer Female.\n\nLinked to the drug Iniparib because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01204125","url":"https://clinicaltrials.gov/study/NCT01204125"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["paclitaxel","iniparib"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01204125","phase":"2","setting":"Randomized, Open-label, Phase 2 Study of the Efficacy and Safety of Weekly Paclitaxel Single-agent and Two Different Regimens of the PARP-1 Inhibitor SAR240550 (BSI-201) in Combination With Weekly Paclitaxel, as Neoadjuvant Therapy in Patients With Stage II-IIIA Triple Negative Breast Cancer (TNBC)","sponsor":"Sanofi","started":"2010-09","enrolled":141,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04513717","kind":"trial","name":"Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial","aka":[],"tldr":"A phase 3 trial of Apalutamide, Bicalutamide, Buserelin, Degarelix, Flutamide, Goserelin / leuprolide, Histrelin, Leuprolide, Relugolix and Triptorelin in Prostate cancer, run by NRG Oncology, active and no longer recruiting.","summary":"Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial is a phase 3 interventional study registered as NCT04513717 by NRG Oncology, with 2753 participants planned, started 2021-01-21 and due to reach its primary completion in 2033-12-31. Interventions recorded: Apalutamide, Bicalutamide, Biospecimen Collection, Bone Scan, Buserelin, Computed Tomography, Degarelix, Flutamide, Goserelin, Histrelin, Leuprolide, Magnetic Resonance Elastography, Positron Emission Tomography, Quality-of-Life Assessment, Questionnaire Administration, Radiation Therapy, Relugolix, Triptorelin. Conditions recorded: Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8.\n\nLinked to the drug Buserelin because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04513717","url":"https://clinicaltrials.gov/study/NCT04513717"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["apalutamide","bicalutamide","buserelin","degarelix","flutamide","goserelin","histrelin","leuprolide","relugolix","triptorelin"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04513717","phase":"3","setting":"Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)","sponsor":"NRG Oncology","started":"2021-01-21","startedType":"actual","enrolled":2753,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05948813","kind":"trial","name":"TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases","aka":[],"tldr":"A phase 2 trial of TY-9591 and Osimertinib in non-small-cell lung cancer and brain and spinal cord tumours, run by TYK Medicines, Inc, now recruiting.","summary":"TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases is a phase 2 interventional study registered as NCT05948813 by TYK Medicines, Inc, with 420 participants planned, started 2023-08-17 and due to reach its primary completion in 2025-12-15. Interventions recorded: TY-9591 and Osimertinib.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05948813","url":"https://clinicaltrials.gov/study/NCT05948813"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","brain-tumours","secondary-brain-tumours","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ty-9591","osimertinib"],"companies":["tyk-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05948813","phase":"2","setting":"A Phase II Study of TY-9591 Tablets in Patients With EGFR-Mutated Non-small Cell Lung Cancer With Brain Metastases","sponsor":"TYK Medicines, Inc","started":"2023-08-17","startedType":"actual","enrolled":420,"enrolledBasis":"registry","outcomes":[]},{"id":"ukfss","kind":"trial","name":"UK Flexible Sigmoidoscopy Screening Trial","aka":["UKFSST","ISRCTN28352761"],"tldr":"The trial that showed one look inside the lower bowel in your late fifties can prevent a bowel cancer for life, and that a single test is enough.","summary":"The UK Flexible Sigmoidoscopy Screening Trial offered 57,237 people a single flexible sigmoidoscopy between 55 and 64 and compared them with 113,195 who were not contacted. Seven in ten attended. After a median 11.2 years, colorectal cancer incidence in the invited group was 23 percent lower (hazard ratio 0.77, 0.70 to 0.84) and mortality 31 percent lower (0.69, 0.59 to 0.82); among those who actually attended, incidence fell 33 percent and mortality 43 percent, and incidence of distal cancer halved. The 17-year follow-up published in 2017 showed the benefit persisted. The result created Bowel Scope Screening in England, which was later withdrawn in favour of extending the faecal immunochemical test programme down to age 50; NHS England confirmed in January 2021 that bowel scope is no longer offered.","status":"positive","asOf":"2026-09-24","links":[{"label":"Lancet 2010","url":"https://europepmc.org/article/MED/20430429"},{"label":"Lancet 2017: 17-year follow-up","url":"https://europepmc.org/article/MED/28236467"},{"label":"ISRCTN28352761","url":"https://www.isrctn.com/ISRCTN28352761"}],"tags":["uk","screening","colorectal"],"related":[],"cancers":["colorectal"],"sections":["early-detection","prevention"],"technologies":["colorectal-screening"],"targets":[],"drugs":[],"companies":[],"institutions":["imperial-cancer-centre"],"pathways":[],"terms":["colonoscopy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN28352761","phase":"3","setting":"A single flexible sigmoidoscopy between the ages of 55 and 64, offered once, against no contact; 14 UK centres, 170,432 people who had said they would accept an invitation, recruited from July 1995","sponsor":"Imperial College London with the Medical Research Council","result":"Colorectal cancer incidence 23 percent lower and mortality 31 percent lower in those invited to a single flexible sigmoidoscopy (33 percent and 43 percent among attenders); the 17-year follow-up confirmed the effect lasted.","yearReported":2010,"enrolled":170432,"enrolledBasis":"randomised","enrolledNote":"170,432 eligible people were randomly allocated in the Lancet 2010 report; the ISRCTN record gives a target of 170,000 and a final enrolment of 167,882.","outcomes":[]},{"id":"ukctocs","kind":"trial","name":"UKCTOCS","aka":[],"tldr":"The largest screening trial ever run for ovarian cancer found earlier detection but no reduction in deaths, so there is still no recommended screening.","summary":"Over 16 years of follow-up, multimodal screening shifted stage at diagnosis but did not reduce ovarian and tubal cancer deaths by a statistically significant margin (Lancet 2021). It is the central reason no guideline recommends population screening and why effort has moved to risk-reducing salpingectomy and multi-cancer blood tests.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00058032","url":"https://clinicaltrials.gov/study/NCT00058032"},{"label":"Lancet 2021","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00731-5/fulltext"}],"tags":[],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["ultrasound","mced"],"targets":[],"drugs":[],"companies":["mrc-ctu"],"institutions":["cruk"],"pathways":[],"terms":["ca-125","stage-shift"],"trials":[],"people":["usha-menon"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00058032","phase":"3","setting":"Postmenopausal women aged 50-74: annual multimodal (CA-125 algorithm + ultrasound) or ultrasound screening vs no screening","sponsor":"UCL / MRC / CRUK","result":"No significant reduction in ovarian cancer mortality.","started":"2001-04-17","startedType":"actual","yearReported":2021,"enrolled":202638,"enrolledBasis":"registry","outcomes":[{"endpoint":"Ovarian and tubal cancer mortality reduction (multimodal vs none)","primary":true,"unit":"%","arms":[{"name":"Multimodal screening","value":4,"note":"relative reduction, not significant"}],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00731-5/fulltext"}]},{"id":"ukls","kind":"trial","name":"UKLS","aka":["UK Lung Cancer Screening trial","ISRCTN78513845"],"tldr":"The British pilot that showed a risk-model-selected CT scan finds lung cancer early, and whose long follow-up gave the mortality signal that helped justify a national programme.","summary":"UKLS approached 247,354 people, of whom 30.7 percent responded positively, and randomised 4,055 at high predicted risk to a single low-dose CT scan or to usual care. Of 1,994 scanned, 42 (2.1 percent) were diagnosed with lung cancer; 36 of those 42 (85.7 percent) were stage 1 or 2 and 35 (83.3 percent) had surgical resection as their primary treatment. Lung cancer was commoner in the lowest socioeconomic group, and the psychosocial harms of screening were reported as modest and temporary.\n\nAt a median 7.3 years of follow-up there were 30 lung cancer deaths in the screened arm against 46 in the control arm, a relative rate of 0.65 (95 percent confidence interval 0.41 to 1.02, p = 0.062), too small a trial to reach significance alone. Pooled with eight other randomised trials in a random-effects meta-analysis the relative rate was 0.84 (0.76 to 0.92), which the authors called unequivocal support for screening in identified risk groups. The trial also established that a risk model, rather than age and pack-years alone, is the practical way to choose who to invite, which is how the NHS programme now works.","status":"positive","asOf":"2026-09-25","links":[{"label":"Health Technology Assessment 2016","url":"https://europepmc.org/article/MED/27224642"},{"label":"Lancet Regional Health Europe 2021","url":"https://europepmc.org/article/MED/34806061"},{"label":"ISRCTN78513845","url":"https://www.isrctn.com/ISRCTN78513845"}],"tags":["uk","screening","lung"],"related":[],"cancers":["nsclc","lung-cancer"],"sections":["early-detection"],"technologies":["low-dose-ct-screening"],"targets":[],"drugs":[],"companies":[],"institutions":["liverpool-heart-and-chest","royal-papworth","roy-castle-lung-cancer-foundation"],"pathways":[],"terms":[],"trials":["nlst-nelson"],"people":["john-field","david-baldwin"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN78513845","phase":"3","setting":"A single low-dose CT scan against usual care in people aged 50 to 75 selected by the Liverpool Lung Project risk model version 2 at a five-year risk of 5 percent or more; delivered from Liverpool Heart and Chest Hospital and Papworth Hospital, recruiting April 2011 to December 2012","sponsor":"Royal Liverpool and Broadgreen University Hospital Trust, funded by the NIHR Health Technology Assessment Programme and the Roy Castle Lung Cancer Foundation","result":"42 cancers in 1,994 people scanned, 85.7 percent at stage 1 or 2; lung cancer mortality relative rate 0.65 (0.41 to 1.02) at a median 7.3 years, and 0.84 (0.76 to 0.92) pooled with eight other trials.","yearReported":2021,"enrolled":4055,"enrolledBasis":"randomised","enrolledNote":"4,055 people were randomised against a target of 4,000; 247,354 were approached to find them.","outcomes":[{"endpoint":"Lung cancer mortality","primary":true,"unit":"relative rate","arms":[{"name":"Low-dose CT","n":1987,"value":0.65,"note":"30 deaths"},{"name":"Usual care","n":1981,"value":1,"note":"46 deaths"}],"ci":[0.41,1.02],"p":"0.062","source":"https://europepmc.org/article/MED/34806061"}]},{"id":"nct06955325","kind":"trial","name":"Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations","aka":["UPLIFT"],"tldr":"A phase 3 trial of icotinib, ensartinib and benmelstobart in lung cancer, run by The First Affiliated Hospital of Guangzhou Medical University, not yet recruiting.","summary":"Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations is a phase 3, randomised interventional study registered as NCT06955325 by The First Affiliated Hospital of Guangzhou Medical University, with a registry enrolment figure of 270 participants, started 2025-05 and due to reach its primary completion in 2030-12. Interventions recorded: Icotinib; Rezivertinib; Ensartinib; Benmelstobart. Conditions listed: Non-Small Cell Lung Cancer. Primary outcome: Disease-Free Survival (DFS). Lung eligibility wording from the registry: \"* Primary non-squamous NSCLC confirmed by pathology, with no brain metastases\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06955325","url":"https://clinicaltrials.gov/study/NCT06955325"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["icotinib","ensartinib","benmelstobart"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06955325","phase":"3","setting":"A Randomized, Phase III Umbrella Trial of Adjuvant Therapy Versus Observation in Completely Resected High-Risk Stage IA-IB Non-Small Cell Lung Cancer Based on Oncogenic Driver Mutations","sponsor":"The First Affiliated Hospital of Guangzhou Medical University","started":"2025-05","startedType":"estimated","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07503639","kind":"trial","name":"Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of retlirafusp alfa, SHR-8068, cAPOX (capecitabine, oxaliplatin) and cetuximab in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer is a phase 2, randomised interventional study registered as NCT07503639 by Fudan University, with a registry enrolment figure of 134 participants, started 2026-04 and due to reach its primary completion in 2028-04. Interventions recorded: SHR-1701; SHR-8068; Short-course radiotherapy; XELOX (Capecitabine and Oxaliplatin); PD-L1 antibody; cetuximab β; HRS-7058; HRS-4642. Conditions listed: Locally Advanced Colorectal Cancer. Primary outcome: Complete response (CR) rate: rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy.. Colorectal eligibility wording from the registry: \"Stage II/III colon cancer, or stage II/III rectal cancer located less than 10 cm from the anal verge;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07503639","url":"https://clinicaltrials.gov/study/NCT07503639"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","imrt-igrt","monoclonal-antibody","platinum"],"targets":[],"drugs":["retlirafusp-alfa","shr-8068","capox","cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07503639","phase":"2","setting":"An Exploratory Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer Based on Molecular Subtypes","sponsor":"Fudan University","started":"2026-04","startedType":"estimated","enrolled":134,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07407465","kind":"trial","name":"Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.","aka":["CHIMERA"],"tldr":"A phase 2 trial of trastuzumab deruxtecan, capecitabine and bevacizumab (glioblastoma use) in colorectal cancer, run by Gruppo Oncologico del Nord-Ovest, now recruiting.","summary":"Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer. is a phase 2, interventional study registered as NCT07407465 by Gruppo Oncologico del Nord-Ovest, with a registry enrolment figure of 42 participants, started 2025-10-20 and due to reach its primary completion in 2027-10-20. Interventions recorded: Trastuzumab-Deruxtecan (T-DXd); Capecitabine; Bevacizumab. Conditions listed: Colorectal Cancer; Colorectal Adenocarcinoma; Rectal Adenocarcinoma; Rectal Cancer, Adenocarcinoma; Rectal Cancer, Metastatic; Colon Cancer Metastatic; Colon Cancer Adenocarcinoma. Primary outcome: Overall Response Rate. Colorectal eligibility wording from the registry: \"* Have histologically documented adenocarcinoma of the colon or rectum, which is initially metastatic or unresectable locally advanced\". Sites: France, Germany, Italy, Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07407465","url":"https://clinicaltrials.gov/study/NCT07407465"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["adc","cytotoxic-chemotherapy"],"targets":[],"drugs":["trastuzumab-deruxtecan","capecitabine","bevacizumab-glioma"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07407465","phase":"2","setting":"Phase II Single Arm Study of Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer: the CHIMERA Study.","sponsor":"Gruppo Oncologico del Nord-Ovest","started":"2025-10-20","startedType":"actual","enrolled":42,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07217704","kind":"trial","name":"Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.","aka":[],"tldr":"A phase 3 trial of [18F]FAPI-74 PET/CT in oesophageal cancer and gastric & gastro-oesophageal junction cancer, run by SOFIE, now recruiting.","summary":"Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer. is a phase 3 interventional study registered as NCT07217704 by SOFIE, with 200 participants planned, started 2025-11-14 and due to reach its primary completion in 2027-08-30. Interventions recorded: [18F]FAPI-74 PET/CT.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07217704","url":"https://clinicaltrials.gov/study/NCT07217704"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["esophageal","gastric"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sofie-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07217704","phase":"3","setting":"A Phase 3, Multicenter, Prospective Open-Label Study of the Diagnostic Performance of [¹⁸F]FAPI-74 PET/CT for the Detection of Metastatic Disease in Adults With Gastric or Esophageal Cancer","sponsor":"SOFIE","started":"2025-11-14","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04966663","kind":"trial","name":"Using ctDNA to Determine Therapies for Lung Cancer","aka":["ctDNA Lung RCT"],"tldr":"A phase 2 trial of nivolumab, pemetrexed, gemcitabine, cisplatin and other drugs in lung cancer, run by University Health Network, Toronto, now recruiting.","summary":"Using ctDNA to Determine Therapies for Lung Cancer is a phase 2, randomised interventional study registered as NCT04966663 by University Health Network, Toronto, with a registry enrolment figure of 66 participants, started 2022-03-28 and due to reach its primary completion in 2026-08-01. Interventions recorded: Nivolumab; Pemetrexed; Gemcitabine; Cisplatin; Carboplatin; ctDNA blood test. Conditions listed: Non Small Cell Lung Cancer; Complete Surgical Resection; Circulating Tumor DNA. Primary outcome: Relapse Free Survival. Lung eligibility wording from the registry: \"Complete surgical resection of T1-2N0M0 NSCLC or T3/T4 multifocal NSCLC\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04966663","url":"https://clinicaltrials.gov/study/NCT04966663"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","mrd-testing","platinum"],"targets":[],"drugs":["nivolumab","pemetrexed","gemcitabine","cisplatin","carboplatin"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04966663","phase":"2","setting":"From Liquid Biopsy to Cure: Using ctDNA Detection of Minimal Residual Disease to Identify Patients for Curative Therapy After Lung Cancer Resection","sponsor":"University Health Network, Toronto","started":"2022-03-28","startedType":"actual","enrolled":66,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06813079","kind":"trial","name":"Using Tumor Models to Determine Treatments","aka":["ADOPT"],"tldr":"A phase 2 trial of cobimetinib, ponatinib, brigatinib, selinexor and other drugs in pancreatic cancer, run by University Health Network, Toronto, now recruiting.","summary":"Using Tumor Models to Determine Treatments is a phase 2, interventional study registered as NCT06813079 by University Health Network, Toronto, with a registry enrolment figure of 25 participants, started 2025-04-07 and due to reach its primary completion in 2028-02-17. Interventions recorded: Cobimetinib; Ponatinib; Brigatinib; Colchicine; Selinexor; Abemaciclib; Neratinib; Doxorubicin; Etoposide; Ceritinib. Conditions listed: Pancreatic Ductal Carcinoma; Advanced Cancer; Epithelial Tumor. Primary outcome: Objective response rate (ORR). Pancreatic eligibility wording from the registry: \"Advanced inoperable malignant epithelial pancreatic ductal carcinomas (i\". Sites: Canada. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06813079","url":"https://clinicaltrials.gov/study/NCT06813079"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cobimetinib","ponatinib","brigatinib","selinexor","abemaciclib","neratinib","doxorubicin","etoposide","ceritinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06813079","phase":"2","setting":"ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial","sponsor":"University Health Network, Toronto","started":"2025-04-07","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06385990","kind":"trial","name":"Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy","aka":[],"tldr":"A phase 2 trial of utidelone in triple-negative breast cancer, run by Hunan Cancer Hospital, now recruiting.","summary":"Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy is a phase 2, interventional study registered as NCT06385990 by Hunan Cancer Hospital, with a registry enrolment figure of 53 participants, started 2024-03-29 and due to reach its primary completion in 2025-03-29. Interventions recorded: UTD1. Conditions listed: Triple Negative Breast Neoplasms. Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06385990","url":"https://clinicaltrials.gov/study/NCT06385990"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["utidelone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06385990","phase":"2","setting":"Clinical Study of the Efficacy and Safety of Utidelone (UTD1) Combined With Capecitabine as Adjuvant Therapy in Non-pCR Triple-negative Breast Cancer Patients After Neoadjuvant Therapy","sponsor":"Hunan Cancer Hospital","started":"2024-03-29","startedType":"actual","enrolled":53,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06683703","kind":"trial","name":"Utidelone Injection Combined with Bevacizumab Injection for Non-small Cell Lung Cancer Patients with Brain Metastases","aka":[],"tldr":"A phase 2 trial of utidelone and bevacizumab in lung cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd., not yet recruiting.","summary":"Utidelone Injection Combined with Bevacizumab Injection for Non-small Cell Lung Cancer Patients with Brain Metastases is a phase 2, randomised interventional study registered as NCT06683703 by Beijing Biostar Pharmaceuticals Co., Ltd., with a registry enrolment figure of 118 participants, started 2024-12-01 and due to reach its primary completion in 2026-12-01. Interventions recorded: Utidelone combined with Bevacizumab; Utidelone; Utidelone combined with Bevacizumab; Utidelone combined with Bevacizumab. Conditions listed: Non-small Cell Lung Cancer Patients with Brain Metastases. Primary outcome: Intracranial objective response rate (iORR) according to the RECIST 1.1.; Determining the Expansion Dose. Lung eligibility wording from the registry: \"non-squamous non-small cell lung cancer (adenocarcinoma or adenocarcinoma component dominant) with brain parenchymal metastasis confirmed by histology or cytology, but unsuitable or refused local treatment/surgery;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06683703","url":"https://clinicaltrials.gov/study/NCT06683703"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["utidelone","bevacizumab"],"companies":["biostar-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06683703","phase":"2","setting":"Phase II Clinical Trial on the Efficacy and Safety of Utidelone Combined with Bevacizumab in Patients with Non-small Cell Lung Cancer with Brain Metastases.","sponsor":"Beijing Biostar Pharmaceuticals Co., Ltd.","started":"2024-12-01","startedType":"estimated","enrolled":118,"enrolledBasis":"registry","outcomes":[]},{"id":"ux023t-cl201","kind":"trial","name":"UX023T-CL201","aka":["UX023T CL201","Study 6"],"tldr":"This open-label study showed that an antibody blocking the phosphate-wasting hormone FGF23 raised blood phosphate to normal and helped heal fractures in adults whose soft-bone disease was driven by a small tumour that could not be located or removed, which supported Crysvita for that cancer-care use.","summary":"UX023T-CL201 (NCT02304367; US Crysvita label Study 6) was a multicentre, open-label, phase 2 study of burosumab, a fully human monoclonal antibody that inhibits FGF23, in adults with tumour-induced osteomalacia or cutaneous skeletal hypophosphataemia syndrome. The Journal of Bone and Mineral Research 2021 report focuses on 14 patients with tumour-induced osteomalacia, excluding two diagnosed with X-linked hypophosphataemia after enrolment and one with cutaneous skeletal hypophosphataemia syndrome.\n\nKey endpoints were changes in serum phosphorus and osteomalacia on transiliac bone biopsy at week 48. Mean serum phosphorus rose from 0.52 mmol/L at baseline and was maintained after dose titration from week 22 (0.91 mmol/L) to week 144 (0.82 mmol/L, p less than 0.0001). Most histomorphometric measures of osteomalacia improved at week 48 (osteoid volume per bone volume, osteoid thickness and mineralisation lag time fell; osteoid surface per bone surface did not change). Of 249 fractures or pseudofractures present at baseline across the 14 patients, 33 percent were fully healed and 13 percent partially healed at week 144. Patients reported less pain and fatigue and better physical health. Two patients discontinued; 16 serious adverse events occurred in seven patients and there was one death, all judged unrelated to treatment; nine patients had 16 treatment-related adverse events, all mild or moderate.\n\nThe registry lists the study as a completed single-group phase 2 with 17 participants and conditions of tumour-induced osteomalacia and epidermal nevus syndrome, neither a corpus cancer, which is why the automated pass never attached it to the burosumab record.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02304367","url":"https://clinicaltrials.gov/study/NCT02304367"},{"label":"Journal of Bone and Mineral Research 2021","url":"https://doi.org/10.1002/jbmr.4233"},{"label":"Crysvita label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=102f96a0-6e3a-4fc1-b204-34d604683af6"},{"label":"Crysvita EPAR (EMA)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/crysvita"}],"tags":[],"related":[],"cancers":[],"sections":["supportive-care"],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["burosumab"],"companies":["kyowa-kirin"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-ux023t-cl201-jan-de-beur-jbmr-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02304367","phase":"2","setting":"Adults with tumour-induced osteomalacia from phosphaturic mesenchymal tumours that cannot be found or removed: open-label burosumab with dose titration, for FGF23-driven phosphate wasting","sponsor":"Kyowa Kirin","result":"Serum phosphorus rose from 0.52 mmol/L at baseline to 0.82 mmol/L at week 144 (p<0.0001); 33% of baseline fractures or pseudofractures fully healed and 13% partially healed by week 144.","started":"2015-03-24","startedType":"actual","yearReported":2021,"enrolled":14,"enrolledBasis":"analysed","enrolledNote":"The Journal of Bone and Mineral Research 2021 report analyses 14 adults with tumour-induced osteomalacia after excluding two patients found to have X-linked hypophosphataemia after enrolment and one with cutaneous skeletal hypophosphataemia syndrome; ClinicalTrials.gov NCT02304367 lists an actual enrolment of 17.","outcomes":[{"endpoint":"Mean serum phosphorus at week 144 (tumour-induced osteomalacia cohort)","primary":true,"unit":"mmol/L","arms":[{"name":"Burosumab","n":14,"value":0.82,"note":"Baseline 0.52 mmol/L; 0.91 mmol/L at week 22 after dose titration"}],"p":"<0.0001","source":"https://doi.org/10.1002/jbmr.4233"},{"endpoint":"Baseline fractures or pseudofractures fully healed at week 144","unit":"%","arms":[{"name":"Burosumab","n":14,"value":33,"note":"Of 249 fractures or pseudofractures present at baseline across 14 patients; a further 13% partially healed"}],"source":"https://doi.org/10.1002/jbmr.4233"}],"replication":"A separate 13-patient open-label study in Japan and Korea (US Crysvita label Study 7; Imanishi 2021) reported the same direction of effect and is not recorded here."},{"id":"nct02919644","kind":"trial","name":"Vaccination with Autologous Dendritic Cells Loaded with Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer.","aka":["COREVAX-1"],"tldr":"A phase 2 trial in colorectal cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS, now recruiting.","summary":"Vaccination with Autologous Dendritic Cells Loaded with Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer. is a phase 2, interventional study registered as NCT02919644 by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS, with a registry enrolment figure of 19 participants, started 2016-12-02 and due to reach its primary completion in 2026-12. Interventions recorded: autologous dendritic cells loaded with autologous tumour homogenate; IL2. Conditions listed: Stage IV Colorectal Cancer; Curative Resection. Primary outcome: Incidence of Treatment-Emergent Adverse Events; immunological efficacy. Colorectal eligibility wording from the registry: \"Patients must have histologically confirmed stage IV colorectal cancer surgically treated with radical intent\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02919644","url":"https://clinicaltrials.gov/study/NCT02919644"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02919644","phase":"2","setting":"Vaccination with Autologous Dendritic Cells Loaded with Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer: a Phase II Study","sponsor":"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","started":"2016-12-02","startedType":"actual","enrolled":19,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07407647","kind":"trial","name":"Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer","aka":[],"tldr":"A phase 2 trial in colorectal cancer, run by Ohio State University Comprehensive Cancer Center, now recruiting.","summary":"Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer is a phase 2, interventional study registered as NCT07407647 by Ohio State University Comprehensive Cancer Center, with a registry enrolment figure of 25 participants, started 2026-03-12 and due to reach its primary completion in 2026-12-31. Interventions recorded: Biospecimen Collection; Prasterone; Survey Administration. Conditions listed: Anal Carcinoma; Cervical Carcinoma; Malignant Female Reproductive System Neoplasm; Rectal Carcinoma; Vaginal Carcinoma; Vulvar Carcinoma. Primary outcome: Incidence of grade 2 or higher adverse events. Colorectal eligibility wording from the registry: \"* Any patient with anal, rectal, cervical, vaginal, or vulvar cancer receiving external beam radiation alone, or both external beam radiation and brachytherapy with curative intent (Participants will be consented and enrolled prior to starting treatment but will not receive intervention till after t\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07407647","url":"https://clinicaltrials.gov/study/NCT07407647"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07407647","phase":"2","setting":"Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation","sponsor":"Ohio State University Comprehensive Cancer Center","started":"2026-03-12","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04703192","kind":"trial","name":"Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)","aka":["VALENTINE-PTCL01"],"tldr":"A phase 2 trial of Valemetostat Tosylate in peripheral T-cell lymphomas and non-Hodgkin lymphoma, run by Daiichi Sankyo, active and no longer recruiting.","summary":"Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01) is a phase 2 interventional study registered as NCT04703192 by Daiichi Sankyo, with 155 participants enrolled, started 2021-06-03 and due to reach its primary completion in 2023-05-10. Interventions recorded: Valemetostat Tosylate. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04703192","url":"https://clinicaltrials.gov/study/NCT04703192"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["peripheral-t-cell-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04703192","phase":"2","setting":"Single-arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects With Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)","sponsor":"Daiichi Sankyo","started":"2021-06-03","startedType":"actual","yearReported":2024,"enrolled":155,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)","primary":true,"unit":"%","arms":[{"name":"Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)","n":119,"value":43.7,"note":"95% CI 34.6 to 53.1; Figures from the ClinicalTrials.gov results section (first posted 2024-07-22), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04703192?tab=results"}]},{"id":"nct06714357","kind":"trial","name":"ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/Revert Resistance in Colorectal Cancer","aka":["VICTORIA"],"tldr":"A phase 2 trial of fOLFIRI (5-FU, leucovorin, irinotecan) and panitumumab in colorectal cancer, run by National Cancer Institute, Naples, now recruiting.","summary":"ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/Revert Resistance in Colorectal Cancer is a phase 2, randomised interventional study registered as NCT06714357 by National Cancer Institute, Naples, with a registry enrolment figure of 130 participants, started 2025-03-12 and due to reach its primary completion in 2026-12-20. Interventions recorded: irinotecan; panitumumab; Valproic Acid (VPA). Conditions listed: Colorectal Cancer Metastatic. Primary outcome: Study Part 1 - Progression Free Survival rate at 16 weeks in the two arms.. Colorectal eligibility wording from the registry: \"Histologically proven of colorectal adenocarcinoma\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06714357","url":"https://clinicaltrials.gov/study/NCT06714357"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody","topoisomerase-inhibitors"],"targets":[],"drugs":["folfiri","panitumumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06714357","phase":"2","setting":"Randomized Phase 2 Study of Valproic Acid Combined With Rechallenge Anti-EGFR Based Regimen Regimens in Pretreated Patients With RAS/BRAF Wild-type Metastatic Colorectal Cancer - VICTORIA Trial","sponsor":"National Cancer Institute, Naples","started":"2025-03-12","startedType":"actual","enrolled":130,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05821556","kind":"trial","name":"Valproic Acid/Simvastatin Plus Gemcitabine/Nab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients","aka":["VESPA"],"tldr":"A phase 2 trial of nab-paclitaxel, cisplatin and capecitabine in pancreatic cancer, run by National Cancer Institute, Naples, now recruiting.","summary":"Valproic Acid/Simvastatin Plus Gemcitabine/Nab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients is a phase 2, randomised interventional study registered as NCT05821556 by National Cancer Institute, Naples, with a registry enrolment figure of 240 participants, started 2023-06-12 and due to reach its primary completion in 2026-08. Interventions recorded: Valproic acid; Simvastatin 20mg; Gemcitabine 1000 mg; Nab paclitaxel; Cisplatin; Capecitabine. Conditions listed: Adenocarcinoma of the Pancreas. Primary outcome: Progression Free Survival (PFS). Sites: Italy, Spain. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05821556","url":"https://clinicaltrials.gov/study/NCT05821556"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["nab-paclitaxel","cisplatin","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05821556","phase":"2","setting":"Randomized Phase 2 Study of Valproic Acid combinEd With Simvastatin and Gemcitabine/Nab-paclitaxel-based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients (The VESPA Trial).","sponsor":"National Cancer Institute, Naples","started":"2023-06-12","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03463252","kind":"trial","name":"Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC","aka":[],"tldr":"A phase 2/3 trial of Progestins in Endometrial cancer, run by West China Second University Hospital, now recruiting.","summary":"Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC is a phase 2/3 interventional study registered as NCT03463252 by West China Second University Hospital, with 224 participants planned, started 2018-04-01 and due to reach its primary completion in 2025-12-30. Interventions recorded: Progesterone, Mirena®, GnRH agonist. Conditions recorded: Endometrial Cancer, Atypical Endometrial Hyperplasia.\n\nLinked to the drug Progestins because the registry names it among its interventions and Endometrial cancer among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03463252","url":"https://clinicaltrials.gov/study/NCT03463252"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial"],"sections":[],"technologies":[],"targets":[],"drugs":["megestrol-progestins"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03463252","phase":"2/3","setting":"Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma","sponsor":"West China Second University Hospital","started":"2018-04-01","startedType":"actual","enrolled":224,"enrolledBasis":"registry","outcomes":[]},{"id":"vanguard-study","kind":"trial","name":"Vanguard Study (NCI Cancer Screening Research Network)","aka":["The Vanguard Study: Testing a New Way to Screen for Cancer"],"tldr":"The US government's first randomised study of multi-cancer blood tests: 24,000 people are being assigned to a blood test or usual care to work out how a much larger trial should be run.","summary":"The Vanguard study is the National Cancer Institute's randomised feasibility trial for multi-cancer detection tests, run through its Cancer Screening Research Network. The registry lists it as an interventional, randomised study with no drug phase, an estimated 24,000 participants, a start on 18 June 2025, recruiting status, primary completion on 31 January 2029 and study completion on 30 June 2029, across bladder, breast, colorectal, oesophageal, gastric, liver, lung, ovarian, pancreatic and prostate cancers. It is the counterpart to NHS-Galleri: a public-sector randomised test of the approach rather than of one company's product, and its design will decide whether a mortality-powered trial follows.","status":"recruiting","asOf":"2026-09-21","links":[{"label":"ClinicalTrials.gov NCT06995898","url":"https://clinicaltrials.gov/study/NCT06995898"}],"tags":["ctdna-roadmap"],"related":["nhs-galleri","pathfinder-2","galleri","idea-prev-mced-registry-randomised","ctdna-tests"],"cancers":[],"sections":[],"technologies":["mced","liquid-biopsy"],"targets":[],"drugs":[],"companies":[],"institutions":["nci"],"pathways":[],"terms":["stage-shift","ppv"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06995898","phase":"platform","setting":"Adults without a cancer diagnosis in the United States: randomised to a multi-cancer detection blood test or usual care to test whether a full randomised screening trial is feasible","sponsor":"National Cancer Institute","started":"2025-06-18","startedType":"actual","enrolled":24000,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07472933","kind":"trial","name":"Vebotolimab Combined With Ptorlimab for EGFR-positive Refractory Advanced Biliary Tract Malignancies","aka":[],"tldr":"A phase 2 trial of the registered interventions in gallbladder cancer and other biliary tract cancers, run by West China Hospital, not yet recruiting.","summary":"Vebotolimab Combined With Ptorlimab for EGFR-positive Refractory Advanced Biliary Tract Malignancies is a phase 2 interventional study registered as NCT07472933 by West China Hospital, with a registry enrolment figure of 49 participants, started 2026-08-01 and due to reach its primary completion in 2028-02-29. Interventions recorded: Vibecotecotamab combined with Putilimab for EGFR-positive refractory biliary malignant tumors. Conditions listed: Cancer of Biliary Duct. Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07472933","url":"https://clinicaltrials.gov/study/NCT07472933"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07472933","phase":"2","setting":"An Exploratory Study of Vedotin-tislelizumab Combined With Toripalimab in EGFR-positive Refractory Advanced Biliary Tract Malignancies","sponsor":"West China Hospital","started":"2026-08-01","startedType":"estimated","enrolled":49,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07655622","kind":"trial","name":"Vebreltinib Plus Furmonertinib in Patients With EGFR-mutated Advanced Non-small Cell Lung Cancer and High PD-L1 Expression","aka":["DUAL-THRUST"],"tldr":"A phase 1/2 trial of vebreltinib in lung cancer, run by Second Affiliated Hospital of Nanchang University, now recruiting.","summary":"Vebreltinib Plus Furmonertinib in Patients With EGFR-mutated Advanced Non-small Cell Lung Cancer and High PD-L1 Expression is a phase 1/2, interventional study registered as NCT07655622 by Second Affiliated Hospital of Nanchang University, with a registry enrolment figure of 45 participants, started 2026-07-03 and due to reach its primary completion in 2027-12-03. Interventions recorded: Vebreltinib; Furmonertinib 80mg. Conditions listed: Non-Small-Cell Lung Cancer. Primary outcome: Phase Ib: Incidence of Dose-Limiting Toxicities as assessed by protocol-defined criteria and CTCAE v5.0; Phase Ib: Incidence of Grade ≥2 Treatment-Emergent Adverse Events as assessed by CTCAE v5.0; Phase Ib: Rate of dose reduction, interruption, or discontinuation due to treatment-related adverse ev. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed locally advanced (stage IIIB-IIIC), metastatic, or recurrent (stage IV) non-small cell lung cancer, not amenable to surgical resection and definitive concurrent chemoradiotherapy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07655622","url":"https://clinicaltrials.gov/study/NCT07655622"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["vebreltinib"],"companies":["beijing-pearl-biotechnology-limited-liability-company"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07655622","phase":"1/2","setting":"A Single-arm, Phase I/II Trial Aimed to Evaluate the Efficacy and Safety of Vebreltinib Plus Furmonertinb as First-line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Harboring EGFR Mutations and High PD-L1 Expression","sponsor":"Second Affiliated Hospital of Nanchang University","started":"2026-07-03","startedType":"estimated","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06574347","kind":"trial","name":"Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.","aka":["KYLIN-2"],"tldr":"A phase 2 trial of Vebreltinib, Osimertinib in non-small-cell lung cancer and small-cell lung cancer, run by Avistone Biotechnology Co., Ltd., now recruiting.","summary":"Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC. is a phase 2 interventional study registered as NCT06574347 by Avistone Biotechnology Co., Ltd., with 120 participants planned, started 2024-08-07 and due to reach its primary completion in 2026-10-31. Interventions recorded: Vebreltinib, Osimertinib, PLB1004. Conditions listed: Non-Small-Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06574347","url":"https://clinicaltrials.gov/study/NCT06574347"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["vebreltinib","osimertinib"],"companies":["avistone-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06574347","phase":"2","setting":"A Phase II Study of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.","sponsor":"Avistone Biotechnology Co., Ltd.","started":"2024-08-07","startedType":"actual","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06343064","kind":"trial","name":"Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI","aka":["KYLIN-1"],"tldr":"A phase 1/2 trial of Vebreltinib in non-small-cell lung cancer and small-cell lung cancer, run by Avistone Biotechnology Co., Ltd., now recruiting.","summary":"Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI is a phase 1/2 interventional study registered as NCT06343064 by Avistone Biotechnology Co., Ltd., with 156 participants planned, started 2023-06-13 and due to reach its primary completion in 2026-12-31. Interventions recorded: Vebreltinib, PLB1004. Conditions listed: Non-Small-Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06343064","url":"https://clinicaltrials.gov/study/NCT06343064"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["vebreltinib"],"companies":["avistone-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06343064","phase":"1/2","setting":"A Phase Ib/II Study of Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI","sponsor":"Avistone Biotechnology Co., Ltd.","started":"2023-06-13","startedType":"actual","enrolled":156,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06970782","kind":"trial","name":"Vebreltinib Plus PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFRm, MET+, Locally Advanced or Metastatic NSCLC Following EGFR-TKI Failur","aka":["KYLIN-3"],"tldr":"A phase 3 trial of vebreltinib and pemetrexed in lung cancer, run by Avistone Biotechnology Co., Ltd., not yet recruiting.","summary":"Vebreltinib Plus PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFRm, MET+, Locally Advanced or Metastatic NSCLC Following EGFR-TKI Failure is a phase 3, randomised interventional study registered as NCT06970782 by Avistone Biotechnology Co., Ltd., with a registry enrolment figure of 278 participants, started 2025-05-15 and due to reach its primary completion in 2027-12-31. Interventions recorded: Vebreltinib; PLB1004; Pemetrexed plus Carboplatin or Cisplatin. Conditions listed: Non-Small-Cell Lung Cancer. Primary outcome: Progression-Free Survival (PFS) by BICR. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\\~IV)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06970782","url":"https://clinicaltrials.gov/study/NCT06970782"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","met-altered-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["vebreltinib","pemetrexed"],"companies":["avistone-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06970782","phase":"3","setting":"A Randomized, Controlled, Open Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure","sponsor":"Avistone Biotechnology Co., Ltd.","started":"2025-05-15","startedType":"estimated","enrolled":278,"enrolledBasis":"registry","outcomes":[]},{"id":"velour","kind":"trial","name":"VELOUR","aka":[],"tldr":"A decoy receptor that mops up the signals feeding tumour blood vessels added about six weeks of life in second-line treatment. England decided that was not worth the price.","summary":"VELOUR randomised 1,226 patients whose metastatic colorectal cancer had progressed after an oxaliplatin-based regimen, including patients who had already had bevacizumab, to FOLFIRI with ziv-aflibercept 4 mg/kg or placebo every two weeks. Median overall survival was 13.50 against 12.06 months (hazard ratio 0.817, 95.34% CI 0.713 to 0.937, p=0.0032) and progression-free survival also improved (hazard ratio 0.758, 0.661 to 0.869). The FDA approved ziv-aflibercept in August 2012 and the EU marketing authorisation for Zaltrap followed on 1 February 2013, but NICE TA307 in March 2014 did not recommend it, so it is not routinely funded in England. It remains an option in guidelines where the modest absolute gain is judged worthwhile.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00561470","url":"https://clinicaltrials.gov/study/NCT00561470"},{"label":"VELOUR: aflibercept added to FOLFIRI after an oxaliplatin-based regimen (Journal of Clinical Oncology 2012)","url":"https://doi.org/10.1200/JCO.2012.42.8201"},{"label":"NICE TA307: aflibercept in combination with irinotecan and fluorouracil-based therapy (not recommended)","url":"https://www.nice.org.uk/guidance/ta307"},{"label":"EMA Zaltrap","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zaltrap"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy"],"targets":["vegf"],"drugs":["ziv-aflibercept","folfiri","irinotecan","fluorouracil"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":["cancer-drugs-fund"],"trials":["raise"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00561470","phase":"3","setting":"Metastatic colorectal cancer after an oxaliplatin-based regimen: FOLFIRI with ziv-aflibercept or placebo","sponsor":"Sanofi","result":"Median overall survival 13.50 against 12.06 months (hazard ratio 0.817).","started":"2007-11","yearReported":2012,"enrolled":1226,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"FOLFIRI plus ziv-aflibercept","n":612,"value":13.5},{"name":"FOLFIRI plus placebo","n":614,"value":12.06}],"hr":0.817,"ci":[0.713,0.937],"p":"0.0032","source":"https://doi.org/10.1200/JCO.2012.42.8201"}],"replication":"RAISE showed a similar size of benefit for ramucirumab in the same setting (13.3 against 11.7 months)."},{"id":"nct06127654","kind":"trial","name":"Ventilation Imaging to Improve the Quality of Life for Patients With Lung Cancer Treated With Radiation Therapy","aka":["VITaL"],"tldr":"A phase 3 trial in lung cancer, run by University of Sydney, now recruiting.","summary":"Ventilation Imaging to Improve the Quality of Life for Patients With Lung Cancer Treated With Radiation Therapy is a phase 3, randomised interventional study registered as NCT06127654 by University of Sydney, with a registry enrolment figure of 165 participants, started 2026-01-01 and due to reach its primary completion in 2028-12. Interventions recorded: Healthy lung sparing treatment plan. Conditions listed: Lung Cancer. Primary outcome: Patients receiving healthy lung sparing treatment (interventional arm) have better quality of life than patients receiving standard treatment (control arm).. Lung eligibility wording from the registry: \"Histologically proven non-small cell lung cancer\". Sites: Australia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06127654","url":"https://clinicaltrials.gov/study/NCT06127654"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06127654","phase":"3","setting":"VITaL: A Randomised Controlled Trial Investigating Ventilation Imaging to Improve the Quality of Life for Patients With Lung Cancer Treated With Radiation Therapy","sponsor":"University of Sydney","started":"2026-01-01","startedType":"actual","enrolled":165,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05909397","kind":"trial","name":"Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer","aka":["VERITAC-3"],"tldr":"A phase 3 trial of Vepdegestrant and Palbociclib in advanced solid tumours, run by Pfizer, active and no longer recruiting.","summary":"Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer is a phase 3 interventional study registered as NCT05909397 by Pfizer, with 59 participants enrolled, started 2023-08-09 and due to reach its primary completion in 2026-12-30. Interventions recorded: Vepdegestrant (ARV-471/PF-07850327), Palbociclib and Letrozole.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05909397","url":"https://clinicaltrials.gov/study/NCT05909397"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy","protac-degrader"],"targets":[],"drugs":["vepdegestrant","palbociclib"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05909397","phase":"3","setting":"A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF VEPDEGESTRANT (ARV-471/PF-07850327) PLUS PALBOCICLIB VERSUS LETROZOLE PLUS PALBOCICLIB FOR THE TREATMENT OF PARTICIPANTS WITH ESTROGEN RECEPTOR POSITIVE, HER2 NEGATIVE BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE (VERITAC-3)","sponsor":"Pfizer","started":"2023-08-09","startedType":"actual","enrolled":59,"enrolledBasis":"registry","outcomes":[]},{"id":"verify","kind":"trial","name":"VERIFY","aka":["verify"],"tldr":"VERIFY showed that weekly rusfertide, a hepcidin mimetic, freed most PV patients from phlebotomy and improved their symptoms, leading to the drug's approval in 2026.","summary":"VERIFY randomised 293 patients with PV who needed frequent phlebotomies to weekly subcutaneous rusfertide or placebo on top of their usual treatment. Over weeks 20 to 32, 77 percent on rusfertide were responders (no phlebotomy needed) versus 33 percent on placebo, with fewer phlebotomies, sustained haematocrit control and better patient-reported fatigue and itch; the results were presented at ASCO 2025 and published the same year. The FDA approved rusfertide in 2026.","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05210790","url":"https://clinicaltrials.gov/study/NCT05210790"}],"tags":["polycythaemia-vera","mpn"],"related":[],"cancers":["polycythaemia-vera","myeloproliferative-neoplasms"],"sections":[],"technologies":["peptide-drug-conjugate"],"targets":[],"drugs":["rusfertide"],"companies":["protagonist-therapeutics","takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05210790","phase":"3","setting":"Phlebotomy-dependent polycythaemia vera: rusfertide versus placebo added to standard care","sponsor":"Protagonist Therapeutics and Takeda","result":"Response (no phlebotomy eligibility) weeks 20 to 32: 77% vs 33%.","started":"2022-04-01","startedType":"actual","yearReported":2025,"enrolled":293,"enrolledBasis":"registry","outcomes":[{"endpoint":"Clinical response weeks 20 to 32","primary":true,"unit":"%","arms":[{"name":"Rusfertide","n":147,"value":77},{"name":"Placebo","n":146,"value":33}]}]},{"id":"veritac-2","kind":"trial","name":"VERITAC-2","aka":[],"tldr":"The trial that got the first PROTAC approved, with benefit only in tumours with ESR1 mutations.","summary":"VERITAC-2, trial NCT05654623 sponsored by Arvinas and Pfizer and reported in 2025, is the trial that got the first PROTAC, vepdegestrant, approved, with benefit only in tumours carrying ESR1 mutations. It randomised 624 patients with ER-positive, HER2-negative advanced breast cancer after a CDK4/6 inhibitor and endocrine therapy to vepdegestrant or fulvestrant, met its primary progression-free survival endpoint in the ESR1-mutant population and not in the overall population, and led to approval in the second quarter of 2026 for ESR1-mutant disease. OnCo links it to HR-positive breast cancer, the oestrogen receptor as a target, vepdegestrant, fulvestrant and the first PROTAC paper, and it mirrors EMERALD with elacestrant, so two oral ER-degrading agents now show the same pattern. Whether degrading the receptor offers anything over the oral SERDs is the open question.","status":"mixed","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05654623","url":"https://clinicaltrials.gov/study/NCT05654623"}],"tags":[],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy","protac-degrader"],"targets":["estrogen-receptor"],"drugs":["vepdegestrant"],"companies":["arvinas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-protac-concept-sakamoto-pnas-2001"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05654623","phase":"3","setting":"ER+/HER2- advanced breast cancer after CDK4/6 and endocrine therapy: vepdegestrant vs fulvestrant","sponsor":"Arvinas / Pfizer","result":"PFS HR 0.57 in ESR1-mutant; ITT not significant.","started":"2023-03-03","startedType":"actual","yearReported":2025,"enrolled":624,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival, ESR1-mutant (BICR)","primary":true,"unit":"months","arms":[{"name":"Vepdegestrant","n":136,"value":5},{"name":"Fulvestrant","n":134,"value":2.1}],"hr":0.57,"ci":[0.42,0.77],"p":"<0.001","source":"https://ascopubs.org/doi/10.1200/JCO.2025.43.17_suppl.LBA1000"},{"endpoint":"Progression-free survival, ITT","primary":true,"unit":"months","arms":[{"name":"Vepdegestrant","n":313,"value":3.7,"note":"Not significant"},{"name":"Fulvestrant","n":311,"value":3.6}],"hr":0.83,"ci":[0.68,1.02],"source":"https://ascopubs.org/doi/10.1200/JCO.2025.43.17_suppl.LBA1000"}],"replication":"Mirrors EMERALD (elacestrant): benefit confined to ESR1-mutant tumours. Two oral ER-degrading agents now show the same pattern."},{"id":"verona","kind":"trial","name":"VERONA","aka":[],"tldr":"VERONA tested whether adding venetoclax to azacitidine, the combination that transformed treatment of acute myeloid leukaemia in older patients, would also help people with higher-risk myelodysplastic syndromes live longer; it did not meet that goal.","summary":"Venetoclax plus azacitidine became the standard for older or unfit patients with acute myeloid leukaemia after VIALE-A, and early studies suggested the pair produced high response rates in higher-risk myelodysplastic syndromes too. VERONA randomised 531 patients with untreated higher-risk myelodysplastic syndromes to azacitidine with venetoclax or placebo, with overall survival and complete remission as the primary endpoints.\n\nThe trial did not show a significant improvement in overall survival with the combination. It joins a run of failed phase 3 trials in higher-risk disease, including sabatolimab, pevonedistat and magrolimab, and leaves azacitidine alone, or transplant where possible, as the standard.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04401748","url":"https://clinicaltrials.gov/study/NCT04401748"}],"tags":["subtype-trials"],"related":[],"cancers":["mds-higher-risk","mds"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["venetoclax","azacitidine"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["amer-zeidan"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04401748","phase":"3","setting":"Untreated higher-risk myelodysplastic syndromes: azacitidine with venetoclax or placebo","sponsor":"AbbVie","result":"Venetoclax added to azacitidine did not significantly improve overall survival in untreated higher-risk myelodysplastic syndromes.","started":"2020-09-10","startedType":"actual","yearReported":2025,"enrolled":531,"enrolledBasis":"registry","outcomes":[]},{"id":"viale-a","kind":"trial","name":"VIALE-A","aka":[],"tldr":"The trial that gave older AML patients a real treatment: adding venetoclax to azacitidine doubled remission rates and extended survival.","summary":"Median OS 14.7 vs 9.6 months (HR 0.66, 95% CI 0.52-0.85); composite CR 66.4% vs 28.3%; CR 36.7% vs 17.9%. Benefit across IDH1/2 (OS HR 0.35) and NPM1 subgroups; less in FLT3-ITD and TP53. Long-term follow-up (2022): 24-month OS 37.5% vs 16.7%. NEJM 2020. Became the global standard for unfit AML and the backbone for triplet trials.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02993523","url":"https://clinicaltrials.gov/study/NCT02993523"},{"label":"NEJM 2020","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2012971"}],"tags":[],"related":[],"cancers":["aml","aml-older-unfit"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":["bcl2"],"drugs":["venetoclax","azacitidine"],"companies":["abbvie","roche-genentech"],"institutions":[],"pathways":["apoptosis-bcl2"],"terms":["tumor-lysis-syndrome"],"trials":[],"people":["courtney-dinardo"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02993523","phase":"3","setting":"Newly diagnosed AML unfit for intensive chemotherapy: venetoclax + azacitidine vs placebo + azacitidine","sponsor":"AbbVie / Genentech","result":"OS 14.7 vs 9.6 months, HR 0.66; CR 36.7% vs 17.9%.","started":"2017-02-02","startedType":"actual","yearReported":2020,"enrolled":443,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Venetoclax + azacitidine","n":286,"value":14.7},{"name":"Placebo + azacitidine","n":145,"value":9.6}],"hr":0.66,"ci":[0.52,0.85],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2012971"},{"endpoint":"Complete remission","primary":true,"unit":"%","arms":[{"name":"Venetoclax + azacitidine","value":36.7},{"name":"Placebo + azacitidine","value":17.9}],"source":"https://doi.org/10.1056/NEJMoa2012971"},{"endpoint":"Composite CR (CR + CRi)","unit":"%","arms":[{"name":"Venetoclax + azacitidine","value":66.4},{"name":"Placebo + azacitidine","value":28.3}],"source":"https://doi.org/10.1056/NEJMoa2012971"}],"replication":"VIALE-C (venetoclax + low-dose cytarabine) showed a consistent but initially non-significant OS trend; large real-world series (US, Europe, Asia) reproduce ~60% composite CR and 11-15 month median OS."},{"id":"nct00821860","kind":"trial","name":"Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma","aka":["MesoVATS"],"tldr":"A phase 3 trial of Talc in Mesothelioma and Metastatic cancer, run by Papworth Hospital NHS Foundation Trust, completed.","summary":"Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma is a phase 3 interventional study registered as NCT00821860 by Papworth Hospital NHS Foundation Trust, with 196 participants recorded, started 2003-09 and reaching its primary completion in 2013-02. Interventions recorded: talc, therapeutic thoracoscopy, therapeutic videothoracoscopy. Conditions recorded: Malignant Mesothelioma, Metastatic Cancer.\n\nLinked to the drug Talc because the registry names it among its interventions and Mesothelioma and Metastatic cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00821860","url":"https://clinicaltrials.gov/study/NCT00821860"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mesothelioma","metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["talc-sclerosant"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00821860","phase":"3","setting":"Prospective Randomised Controlled Trial of Video-Assisted Thoracoscopic (VAT) Cytoreductive Pleurectomy Compared to Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma","sponsor":"Papworth Hospital NHS Foundation Trust","started":"2003-09","enrolled":196,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07765836","kind":"trial","name":"Vilastobart+Retifanlimab in BRCA or PALB2 Deficient PC","aka":["EKLAVYA-HRD"],"tldr":"A phase 2 trial of retifanlimab in pancreatic cancer, run by Massachusetts General Hospital, not yet recruiting.","summary":"Vilastobart+Retifanlimab in BRCA or PALB2 Deficient PC is a phase 2, interventional study registered as NCT07765836 by Massachusetts General Hospital, with a registry enrolment figure of 40 participants, started 2027-01 and due to reach its primary completion in 2028-12-31. Interventions recorded: vilastobart (XTX101); Retifanlimab. Conditions listed: Pancreatic Cancer Metastatic. Primary outcome: Objective response rate (ORR). Pancreatic eligibility wording from the registry: \"* Participant must have histologically proven metastatic pancreatic cancer\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07765836","url":"https://clinicaltrials.gov/study/NCT07765836"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac","brca-palb2-pdac"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["retifanlimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07765836","phase":"2","setting":"A Phase 2 Study of Fc Enhanced checKpoint bLockade With CTLA4 Antibody Vilastobart in Combination With PD-1 antibodY RetifAnlimab in BRCA or PALB2 Deficient Pancreatic Adenocarcinoma (EKLAVYA-HRD)","sponsor":"Massachusetts General Hospital","started":"2027-01","startedType":"estimated","enrolled":40,"enrolledBasis":"registry","outcomes":[]},{"id":"violet","kind":"trial","name":"VIOLET","aka":["Video-assisted thoracoscopic lobectomy versus conventional Open Lobectomy for lung cancer","ISRCTN13472721"],"tldr":"The UK trial that settled how a lung should be removed: keyhole surgery leaves people functioning better at five weeks and causes fewer serious problems after discharge, with the same survival.","summary":"VIOLET randomised 503 people with early-stage non-small-cell lung cancer to video-assisted thoracoscopic lobectomy or open lobectomy. At five weeks, median physical function on the EORTC quality-of-life questionnaire was 73 after keyhole surgery against 67 after open surgery, a mean difference of 4.65 points (95 percent confidence interval 1.69 to 7.61). Serious adverse events after discharge occurred in 30.7 percent of the keyhole group against 37.8 percent of the open group (risk ratio 0.81, 0.66 to 1.00). At 52 weeks there was no difference in progression-free survival (hazard ratio 0.74) or overall survival (0.67).\n\nThe result matters more now than when it was published: three quarters of English lung resections are done by keyhole or robot, and the National Lung Cancer Audit reports that the number of resections is rising steeply as screening finds more early cancers.","status":"positive","asOf":"2026-09-25","links":[{"label":"NEJM Evidence 2022","url":"https://europepmc.org/article/MED/38319202"},{"label":"ISRCTN13472721","url":"https://www.isrctn.com/ISRCTN13472721"}],"tags":["uk","surgery","lung"],"related":[],"cancers":["nsclc","lung-cancer","resectable-nsclc"],"sections":["surgery"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["guys-st-thomas","birmingham-cancer-centre"],"pathways":[],"terms":["lobectomy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN13472721","phase":"3","setting":"Video-assisted thoracoscopic lobectomy against open lobectomy in cT1a to T2b, N0 to N1, M0 non-small-cell lung cancer, recruiting July 2015 to March 2019","sponsor":"Royal Brompton and Harefield NHS Foundation Trust, funded by the NIHR Health Technology Assessment Programme","result":"Physical function at five weeks 4.65 points better after keyhole surgery; serious adverse events after discharge 30.7 against 37.8 percent; no difference in progression-free or overall survival at a year.","yearReported":2022,"enrolled":503,"enrolledBasis":"randomised","enrolledNote":"503 participants were randomised against a target of 498.","outcomes":[]},{"id":"vision","kind":"trial","name":"VISION","aka":[],"tldr":"VISION was the trial that established radioligand therapy in prostate cancer.","summary":"VISION, trial NCT03511664 sponsored by Novartis and published in the New England Journal of Medicine in 2021, was the trial that established radioligand therapy in prostate cancer. It randomised 831 men with PSMA-positive metastatic castration-resistant prostate cancer after an androgen receptor pathway inhibitor and a taxane to 177Lu-PSMA-617 plus standard care or standard care alone, selected by PSMA PET, and met both primary endpoints of overall and radiographic progression-free survival. Whether radioligand therapy should now be given before chemotherapy or even at diagnosis, as PSMAfore and PSMAddition test, is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT03511664","url":"https://clinicaltrials.gov/study/NCT03511664"},{"label":"NICE TA930: lutetium-177 vipivotide tetraxetan for treating PSMA-positive hormone-relapsed metastatic prostate cancer after 2 or more treatments, not recommended","url":"https://www.nice.org.uk/guidance/ta930"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["radioligand-therapy","psma-pet"],"targets":["psma"],"drugs":["pluvicto"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":["prostate-crpc-sequencing","prostate-uk-drug-approvals"],"trials":["therap","psmafore","alsympca"],"people":["oliver-sartor","ken-herrmann","michael-morris"],"bottlenecks":[],"keyPapers":["paper-vision-nejm-2021"],"journals":[],"dependsOn":[],"notes":["In England NICE TA930 does not recommend lutetium-177 vipivotide tetraxetan, within its marketing authorisation, for PSMA-positive hormone-relapsed metastatic prostate cancer after taxane-based chemotherapy and an anti-androgen, or when taxanes are medically unsuitable. The committee noted that treatments at this stage include best supportive care and retreatment with taxanes such as cabazitaxel, that some men are eligible for radium-223 dichloride, and that no evidence was submitted comparing lutetium-177 vipivotide tetraxetan with radium-223 so that comparison could not be considered. It accepted that the radioligand increases both time to progression and overall survival against best supportive care. This is the widest gap between marketing authorisation and NHS funding in prostate cancer."],"nct":"NCT03511664","phase":"3","setting":"PSMA+ metastatic castration-resistant prostate cancer after ARPI and taxane: 177Lu-PSMA-617 + SOC vs SOC","sponsor":"Novartis","result":"OS HR 0.62.","started":"2018-05-29","startedType":"actual","yearReported":2021,"enrolled":861,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"177Lu-PSMA-617 + standard care","n":551,"value":15.3},{"name":"Standard care","n":280,"value":11.3}],"hr":0.62,"ci":[0.52,0.74],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2107322"},{"endpoint":"Radiographic progression-free survival","primary":true,"unit":"months","arms":[{"name":"177Lu-PSMA-617 + standard care","value":8.7},{"name":"Standard care","value":3.4}],"hr":0.4,"ci":[0.29,0.57],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2107322"}],"replication":"Consistent with TheraP (phase 2, 177Lu-PSMA-617 vs cabazitaxel: higher PSA response, similar OS) and with PSMAfore in an earlier line."},{"id":"nct02864992","kind":"trial","name":"VISION (tepotinib)","aka":["VISION","MS200095-0022","Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)"],"tldr":"VISION showed that a once-daily MET tablet shrank about half of advanced lung cancers driven by a MET exon 14 skipping mutation, whether the mutation was found in blood or in tumour tissue, which led to tepotinib's approvals in Japan, the United States and Europe.","summary":"VISION (NCT02864992; sponsor code MS200095-0022) is an open-label, single-arm phase 2 study of tepotinib 500 mg once daily in advanced non-small-cell lung cancer with MET exon 14 skipping, detected in circulating tumour DNA, tumour tissue or both, with a later cohort in MET amplification. The primary endpoint was objective response by independent review among patients followed for at least nine months.\n\nIn the NEJM 2020 primary analysis (Paik and colleagues), 152 patients had received tepotinib by 1 January 2020 and 99 had at least nine months of follow-up. The independent-review response rate in the combined-biopsy group was 46 percent (95 percent CI 36 to 57), with a median duration of response of 11.1 months (95 percent CI 7.2 to not estimable). Response rates were 48 percent among 66 patients in the liquid-biopsy group and 50 percent among 60 in the tissue-biopsy group; 27 patients were positive by both. The investigator-assessed response rate was 56 percent and did not depend on previous treatment for advanced disease. Grade 3 or higher treatment-related adverse events occurred in 28 percent, including peripheral oedema in 7 percent, and adverse events led to permanent discontinuation in 11 percent. A molecular response in circulating free DNA was seen in 67 percent of patients with matched samples.\n\nJapan approved tepotinib in 2020, the United States in 2021 (with full approval in 2024) and the EU in 2022. The registry lists 337 participants across all cohorts and the study as active, not recruiting, with completion expected in August 2026. Capmatinib (GEOMETRY mono-1) is the other approved MET exon 14 inhibitor; the Pluvicto prostate-cancer trial also named VISION is a different study (id vision, NCT03511664).","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02864992","url":"https://clinicaltrials.gov/study/NCT02864992"},{"label":"NEJM 2020","url":"https://doi.org/10.1056/NEJMoa2004407"}],"tags":["pipeline","issue-92"],"related":[],"cancers":["nsclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["met"],"drugs":["tepotinib"],"companies":["merck-kgaa"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-vision-tepotinib-paik-nejm-2020","paper-nct02864992-jama-oncol-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02864992","phase":"2","setting":"Advanced or metastatic non-small-cell lung cancer with a confirmed MET exon 14 skipping mutation: tepotinib 500 mg once daily until progression, in cohorts defined by liquid biopsy, tissue biopsy or both","sponsor":"EMD Serono Research & Development Institute, Inc.","result":"Independent-review objective response 46% (95% CI 36 to 57) among 99 patients with at least nine months of follow-up; median duration of response 11.1 months (Paik, NEJM 2020).","started":"2016-09-13","startedType":"actual","yearReported":2020,"enrolled":337,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate by independent review, combined-biopsy group (at least 9 months of follow-up)","primary":true,"unit":"%","arms":[{"name":"Tepotinib 500 mg daily","n":99,"value":46,"note":"95% CI 36 to 57; 152 patients had received tepotinib by the 1 January 2020 cutoff"}],"source":"https://doi.org/10.1056/NEJMoa2004407"},{"endpoint":"Median duration of response by independent review, combined-biopsy group","unit":"months","arms":[{"name":"Tepotinib 500 mg daily","n":99,"value":11.1,"note":"95% CI 7.2 to not estimable"}],"source":"https://doi.org/10.1056/NEJMoa2004407"},{"endpoint":"Objective response rate by independent review, liquid-biopsy group","unit":"%","arms":[{"name":"Tepotinib 500 mg daily","n":66,"value":48,"note":"95% CI 36 to 61"}],"source":"https://doi.org/10.1056/NEJMoa2004407"},{"endpoint":"Objective response rate by independent review, tissue-biopsy group","unit":"%","arms":[{"name":"Tepotinib 500 mg daily","n":60,"value":50,"note":"95% CI 37 to 63"}],"source":"https://doi.org/10.1056/NEJMoa2004407"},{"endpoint":"Grade 3 or higher treatment-related adverse events","unit":"%","arms":[{"name":"Tepotinib 500 mg daily","n":152,"value":28,"note":"Peripheral oedema 7%; adverse events led to permanent discontinuation in 11%"}],"source":"https://doi.org/10.1056/NEJMoa2004407"}],"replication":"GEOMETRY mono-1 (capmatinib) reported response rates of 68 percent in treatment-naive and 41 percent in previously treated MET exon 14 skipping lung cancer; both drugs are approved for this population, so the class effect is established."},{"id":"vismoneo","kind":"trial","name":"VISMONEO (vismodegib before surgery for locally advanced basal cell carcinoma)","aka":["VISMONEO"],"tldr":"Giving the hedgehog pill first to shrink a large facial basal cell carcinoma made the operation smaller or less disfiguring in four out of five people. Over three years, though, more than a third of those who benefited had the cancer back.","summary":"The argument for a drug in basal cell carcinoma is usually about inoperable disease. VISMONEO asked a different and more common question: can the drug make an operable but disfiguring operation into a smaller one? Fifty-five patients with a facial basal cell carcinoma, median age 73 and mean target lesion size 47.3 mm, were given vismodegib 150 mg daily for four to ten months and then operated on once the best response had been reached. Four were inoperable at entry, fifteen operable with a major functional risk and 36 operable with a minor functional risk or a major risk to appearance.\n\nForty-four patients (80 per cent, 95 per cent confidence interval 67 to 90) were downstaged on the six-stage surgical classification, which was the primary endpoint. Of those 44, 27 had a complete response, 25 of them proved on biopsy. The objective response rate by the standard tumour response criteria was 71 per cent (59 to 88) and the mean treatment duration was 6.0 months.\n\nThe three-year follow-up is the part that is usually left out of the summary and should not be: 16 of the 44 downstaged patients had a known recurrence, 36 per cent (22 to 51). A neoadjuvant hedgehog inhibitor changes the operation. It does not remove the need for one, and it does not make the disease go away.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02667574","url":"https://clinicaltrials.gov/study/NCT02667574"},{"label":"First results (EClinicalMedicine 2021)","url":"https://doi.org/10.1016/j.eclinm.2021.100844"},{"label":"First results on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/33997740/"}],"tags":[],"related":[],"cancers":["basal-cell-carcinoma","locally-advanced-bcc","skin-cancer"],"sections":[],"technologies":["hedgehog-inhibitors"],"targets":["smoothened"],"drugs":["vismodegib"],"companies":["roche-genentech"],"institutions":[],"pathways":["hedgehog"],"terms":["hedgehog-inhibitor-tolerability","mohs-surgery"],"trials":["erivance","stevie","cemiplimab-advanced-bcc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02667574","phase":"2","setting":"At least one histologically confirmed facial basal cell carcinoma, inoperable or operable only with a risk of functional loss or major disfigurement: oral vismodegib 150 mg daily for four to ten months before planned surgery, with the proportion of patients whose surgery was downstaged on a six-stage surgical classification as the primary endpoint","sponsor":"University Hospital, Lille, funded by F. Hoffmann-La Roche","result":"Surgical downstaging in 44 of 55 patients (80 per cent, 95 per cent confidence interval 67 to 90) with 27 complete responses, an objective response rate of 71 per cent, and recurrence in 16 of the 44 downstaged patients (36 per cent) by three years.","started":"2014-11-18","startedType":"actual","yearReported":2021,"enrolled":55,"enrolledBasis":"registry","outcomes":[{"endpoint":"Surgical downstaging after neoadjuvant vismodegib","primary":true,"unit":"%","arms":[{"name":"Vismodegib 150 mg daily before surgery","n":55,"value":80,"note":"44 of 55 patients; 95 per cent confidence interval 67 to 90"}],"source":"https://doi.org/10.1016/j.eclinm.2021.100844"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Vismodegib 150 mg daily before surgery","n":55,"value":71,"note":"95 per cent confidence interval 59 to 88"}],"source":"https://doi.org/10.1016/j.eclinm.2021.100844"},{"endpoint":"Recurrence at 3 years among downstaged patients","unit":"%","arms":[{"name":"Vismodegib 150 mg daily before surgery","n":44,"value":36,"note":"16 of 44 patients; 95 per cent confidence interval 22 to 51"}],"source":"https://doi.org/10.1016/j.eclinm.2021.100844"}],"replication":"No second randomised trial of neoadjuvant vismodegib exists. The published periocular and facial experience is a set of small single-arm series, and no source could be found for a figure on how often the histological response matches the clinical one, which is the question the trial leaves open."},{"id":"vistogard-studies-1-2","kind":"trial","name":"Vistogard Studies 1 and 2","aka":["401.10.001","Uridine triacetate expanded-access studies"],"tldr":"Vistogard Studies 1 and 2 gave an oral uridine antidote quickly after a fluorouracil or capecitabine overdose or early severe toxicity; almost everyone treated survived, while most people in an earlier group given supportive care alone had died, and the studies were the main evidence for the US approval of Vistogard.","summary":"Vistogard Studies 1 and 2 were two open-label expanded-access studies of oral uridine triacetate for adults and children after a fluorouracil or capecitabine overdose, or with early-onset severe or life-threatening toxicity. Uridine triacetate was started as soon as possible, in most patients within 96 hours of the fluorouracil or capecitabine; the label dose is 10 g by mouth every six hours for 20 doses, with a body-surface-area dose for young children. Outcomes were survival, resumption of chemotherapy and safety, and survival was compared with a historical cohort of overdose patients who received only supportive care.\n\nIn the Cancer 2017 combined analysis, 137 of 142 overdose patients (96 percent) treated with uridine triacetate survived and had rapid reversal of severe acute cardiotoxicity and neurotoxicity. In the historical supportive-care cohort, 21 of 25 patients (84 percent) died. Among 141 treated overdose patients with a cancer diagnosis, 53 resumed chemotherapy (Cancer 2017).\n\nThe US Vistogard label names the same programme as Study 1 (60 patients) and Study 2 (75 patients), pools 135 patients (117 overdose, 18 early-onset toxicity), and reports survival at 30 days or until chemotherapy resumed of 130 of 135 (96 percent), with 114 of 117 (97 percent) in the overdose group, against the same historical 25-patient supportive-care cohort in which 84 percent died. The FDA approved Vistogard in December 2015. The registry lists the Wellstat expanded-access protocol under org id 401.10.001 as approved for marketing, without a phase or enrolment count. The programme treats overdose and early severe toxicity rather than a cancer, so it carries no cancer ids.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01432301","url":"https://clinicaltrials.gov/study/NCT01432301"},{"label":"Cancer 2017","url":"https://doi.org/10.1002/cncr.30321"},{"label":"Vistogard label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=269f7363-63ed-444e-85f1-f0009e44818b"}],"tags":[],"related":["fluorouracil","capecitabine"],"cancers":[],"sections":["supportive-care"],"technologies":[],"targets":[],"drugs":["uridine-triacetate"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-vistogard-cancer-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01432301","phase":"2","setting":"Emergency treatment after fluorouracil or capecitabine overdose, or early-onset severe or life-threatening toxicity within 96 hours: oral uridine triacetate compared with a historical supportive-care overdose cohort","sponsor":"Wellstat Therapeutics","result":"Survival 96% (137 of 142) with uridine triacetate; historical supportive-care overdose cohort mortality 84% (21 of 25).","yearReported":2017,"enrolled":142,"enrolledBasis":"analysed","enrolledNote":"The Cancer 2017 abstract reports survival for 142 overdose patients, the Vistogard label pools Study 1 (n=60) and Study 2 (n=75) as 135 patients, and ClinicalTrials.gov NCT01432301 (expanded access, org id 401.10.001) posts no enrolment count.","outcomes":[{"endpoint":"Survival (overdose patients)","primary":true,"unit":"%","arms":[{"name":"Uridine triacetate","n":142,"value":96,"note":"137 of 142 overdose patients survived; historical supportive-care cohort: 21 of 25 (84%) died"}],"source":"https://doi.org/10.1002/cncr.30321"},{"endpoint":"Survival at 30 days or until chemotherapy resumed (US label, Studies 1 and 2 combined)","unit":"%","arms":[{"name":"Uridine triacetate","n":135,"value":96,"note":"130 of 135; overdose 114 of 117 (97%), early-onset toxicity 16 of 18 (89%)"}],"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=269f7363-63ed-444e-85f1-f0009e44818b"}]},{"id":"nct07112196","kind":"trial","name":"Visugromab in Cachexia International Trial","aka":["VINCIT"],"tldr":"A phase 2/3 trial of Visugromab, run by CatalYm GmbH, now recruiting.","summary":"Visugromab in Cachexia International Trial is a phase 2/3 interventional study registered as NCT07112196 by CatalYm GmbH, with 518 participants planned, started 2026-04-16. Conditions listed: Cancer-associated Cachexia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07112196","url":"https://clinicaltrials.gov/study/NCT07112196"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["visugromab"],"companies":["catalym"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07112196","phase":"2/3","setting":"Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo in Patients With Cancer-associated Cachexia","sponsor":"CatalYm GmbH","started":"2026-04-16","startedType":"actual","enrolled":518,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07219459","kind":"trial","name":"Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)","aka":["GDFATHER HCC-01"],"tldr":"A phase 2 trial of Visugromab, Nivolumab, Lenvatinib in hepatocellular carcinoma, run by CatalYm GmbH, now recruiting.","summary":"Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure is a phase 2 interventional study registered as NCT07219459 by CatalYm GmbH, with 104 participants planned, started 2026-03-19 and due to reach its primary completion in 2029-09. Interventions recorded: Visugromab RDE (recommended dose for expansion), Nivolumab, Lenvatinib, Placebo Saline Infusion. Conditions listed: Unresectable or Metastatic Hepatocellular Carcinoma, Child-Pugh A Hepatocellular Carcinoma, Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07219459","url":"https://clinicaltrials.gov/study/NCT07219459"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["visugromab","nivolumab","lenvatinib"],"companies":["catalym"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07219459","phase":"2","setting":"A Phase 2b, Randomized, Blinded Trial Investigating the Efficacy and Safety of Visugromab in Combination With Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Participants With Unresectable or Metastatic Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A) After Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound (GDFATHER HCC-01)","sponsor":"CatalYm GmbH","started":"2026-03-19","startedType":"actual","enrolled":104,"enrolledBasis":"registry","outcomes":[]},{"id":"vital","kind":"trial","name":"VITAL (VITamin D and OmegA-3 TriaL)","aka":[],"tldr":"The definitive test of whether vitamin D or fish-oil pills prevent cancer or heart disease in healthy adults. They did not.","summary":"25,871 participants (including 5,106 Black participants) followed for a median 5.3 years. Vitamin D did not reduce invasive cancer incidence (793 vs 824 events, HR 0.96, 95% CI 0.88-1.06) or major cardiovascular events (HR 0.97); omega-3 did not reduce cancer (HR 1.03) or major cardiovascular events (HR 0.92), though it reduced myocardial infarction in secondary analysis. Total cancer mortality with vitamin D was HR 0.83 (0.67-1.02) overall and HR 0.75 (0.59-0.96) after excluding the first two years, a pre-specified but secondary analysis. Later ancillary analyses reported fewer advanced (metastatic or fatal) cancers with vitamin D, concentrated in normal-weight participants. The trial ended the hope of broad cancer prevention with supplements while leaving a testable mortality hypothesis.","status":"negative","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT01169259","url":"https://clinicaltrials.gov/study/NCT01169259"},{"label":"Vitamin D results (NEJM 2019)","url":"https://doi.org/10.1056/NEJMoa1809944"},{"label":"Omega-3 results (NEJM 2019)","url":"https://doi.org/10.1056/NEJMoa1809946"}],"tags":[],"related":["idea-reg-vitamin-d-digestive-cancer-biomarker-trial"],"cancers":[],"sections":["nutrition-lifestyle","prevention"],"technologies":["vitamin-d-omega3-supplementation","chemoprevention"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["unproven-diet-claims","hazard-ratio"],"trials":[],"people":[],"bottlenecks":["b-negative-results","b-misinformation"],"keyPapers":["paper-manson-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01169259","phase":"3","setting":"Primary prevention in US adults (men 50+, women 55+) without prior cancer or cardiovascular disease: vitamin D3 2000 IU/day and/or marine omega-3 1 g/day vs placebo, 2x2 factorial","sponsor":"Brigham and Women's Hospital / NIH","result":"Invasive cancer incidence HR 0.96 (vitamin D), 1.03 (omega-3); no benefit on primary endpoints.","started":"2010-07","startedType":"actual","yearReported":2018,"enrolled":25871,"enrolledBasis":"registry","outcomes":[{"endpoint":"Invasive cancer of any type","primary":true,"unit":"events","arms":[{"name":"Vitamin D3","n":12927,"value":793},{"name":"Placebo","n":12944,"value":824}],"hr":0.96,"ci":[0.88,1.06],"p":"0.47","source":"https://doi.org/10.1056/NEJMoa1809944"},{"endpoint":"Invasive cancer of any type","primary":true,"unit":"events","arms":[{"name":"Omega-3","n":12933,"value":820},{"name":"Placebo","n":12938,"value":797}],"hr":1.03,"ci":[0.93,1.13],"source":"https://doi.org/10.1056/NEJMoa1809946"}],"replication":"Consistent with D-Health (Australia, 21,315 participants, no reduction in mortality or cancer) and with meta-analyses showing no effect on incidence and a possible 10-15% reduction in cancer mortality."},{"id":"nct06601283","kind":"trial","name":"Vitamin C Plus Cordyceps to Chemotherapy Related Anemia in Pancreatic Cancer","aka":[],"tldr":"A phase 2/3 trial in pancreatic cancer, run by Fudan University, now recruiting.","summary":"Vitamin C Plus Cordyceps to Chemotherapy Related Anemia in Pancreatic Cancer is a phase 2/3, interventional study registered as NCT06601283 by Fudan University, with a registry enrolment figure of 50 participants, started 2024-11-22 and due to reach its primary completion in 2026-11-22. Interventions recorded: Vitmain C plus herbal medicine. Conditions listed: Pancreatic Cancer. Primary outcome: Rate of anemia. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed metastatic pancreas adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06601283","url":"https://clinicaltrials.gov/study/NCT06601283"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06601283","phase":"2/3","setting":"Vitamin C Plus Cordyceps to Chemotherapy Related Anemia in Pancreatic Cancer","sponsor":"Fudan University","started":"2024-11-22","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06598033","kind":"trial","name":"Vitamin C Plus Cordyceps to Quality of Life in Patients With Terminal Stage Pancreatic Cancer","aka":[],"tldr":"A phase 2/3 trial in pancreatic cancer, run by Fudan University, now recruiting.","summary":"Vitamin C Plus Cordyceps to Quality of Life in Patients With Terminal Stage Pancreatic Cancer is a phase 2/3, interventional study registered as NCT06598033 by Fudan University, with a registry enrolment figure of 50 participants, started 2024-11-22 and due to reach its primary completion in 2026-10-01. Interventions recorded: VC plus herbal medicine. Conditions listed: Pancreatic Cancer. Primary outcome: Quality of life (QOL) questionnaire. Pancreatic eligibility wording from the registry: \"* Histologically or cytologically confirmed metastatic pancreas adenocarcinoma\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06598033","url":"https://clinicaltrials.gov/study/NCT06598033"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06598033","phase":"2/3","setting":"Vitamin C Plus Cordyceps to Quality of Life in Patients With Terminal Stage Pancreatic Cancer","sponsor":"Fudan University","started":"2024-11-22","startedType":"actual","enrolled":50,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04094688","kind":"trial","name":"Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer","aka":["SOLARIS"],"tldr":"A phase 3 trial of bevacizumab (glioblastoma use), fOLFOX (5-FU, leucovorin, oxaliplatin), leucovorin (folinic acid), fluorouracil (5-FU) and other drugs in colorectal cancer, run by Alliance for Clinical Trials in Oncology, active but no longer recruiting.","summary":"Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT04094688 by Alliance for Clinical Trials in Oncology, with a registry enrolment figure of 455 participants, started 2019-10-29 and due to reach its primary completion in 2024-07-15. Interventions recorded: Bevacizumab; Oxaliplatin; Leucovorin Calcium; Fluorouracil; Irinotecan Hydrochloride; Irinotecan; Cholecalciferol; Quality-of-Life Assessment; Questionnaire Administration. Conditions listed: Colorectal Adenocarcinoma. Primary outcome: Progression-free Survival (PFS). Colorectal eligibility wording from the registry: \"* Histologically confirmed advanced/metastatic colorectal adenocarcinoma for which metastasectomy is not planned\". Sites: Puerto Rico, United States. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04094688","url":"https://clinicaltrials.gov/study/NCT04094688"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["bevacizumab-glioma","folfox","leucovorin","fluorouracil","irinotecan","folfiri"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04094688","phase":"3","setting":"Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients With Previously Untreated Metastatic Colorectal Cancer (SOLARIS)","sponsor":"Alliance for Clinical Trials in Oncology","started":"2019-10-29","startedType":"actual","yearReported":2026,"enrolled":455,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Arm I (Bevacizumab, Chemotherapy, High-dose Vitamin D3)","n":228,"value":11.8,"note":"95% CI 10.3 to 13.3; Figures from the ClinicalTrials.gov results section (first posted 2026-03-03), not from a publication"},{"name":"Arm II (Bevacizumab, Chemotherapy, Standard-dose Vitamin D3)","n":227,"value":10.3,"note":"95% CI 9.4 to 12.2"}],"hr":0.92,"ci":[0.73,1.16],"p":"0.25","source":"https://clinicaltrials.gov/study/NCT04094688?tab=results"}]},{"id":"nct05771181","kind":"trial","name":"Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients","aka":[],"tldr":"A phase 2 trial of fruquintinib and tislelizumab in colorectal cancer, run by Fudan University, now recruiting.","summary":"Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients is a phase 2, interventional study registered as NCT05771181 by Fudan University, with a registry enrolment figure of 25 participants, started 2023-03-01 and due to reach its primary completion in 2025-12. Interventions recorded: Vitamin E; Fruquintinib; Tislelizumab. Conditions listed: Colorectal Cancer; Microsatellite Stable Colorectal Carcinoma. Primary outcome: objective response rate (ORR). Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05771181","url":"https://clinicaltrials.gov/study/NCT05771181"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["fruquintinib","tislelizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05771181","phase":"2","setting":"Phase II Clinical Study of Vitamin E Combined With Fruquintinib and Tislelizumab in Patients With Microsatellite Stabilized Metastatic Colorectal Cancer Who Failed Standard Therapy","sponsor":"Fudan University","started":"2023-03-01","startedType":"actual","enrolled":25,"enrolledBasis":"registry","outcomes":[]},{"id":"nct03556228","kind":"trial","name":"VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in salivary gland cancers and non-small-cell lung cancer, run by VM Oncology, LLC, now recruiting.","summary":"VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma is a phase 1/2 interventional study registered as NCT03556228 by VM Oncology, LLC, with 242 participants planned, started 2018-06-08 and due to reach its primary completion in 2027-12. Interventions recorded: VMD-928 100 mg Tablet, VMD-928 Tablet and Pembrolizumab (200 mg). Conditions listed: Head and Neck Carcinoma, Adenoid Cystic Carcinoma, Lung Cancer, Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03556228","url":"https://clinicaltrials.gov/study/NCT03556228"}],"tags":["ctgov-ingest"],"related":[],"cancers":["salivary-gland","nsclc","sclc","mesothelioma","head-and-neck"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03556228","phase":"1/2","setting":"A Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 as Monotherapy and in Combination With Pembrolizumab in Subjects With Solid Tumors or Lymphoma","sponsor":"VM Oncology, LLC","started":"2018-06-08","startedType":"actual","enrolled":242,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06264180","kind":"trial","name":"VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]","aka":["IGNYTE-3"],"tldr":"A phase 3 trial of Vusolimogene oderparepvec, Nivolumab, Relatlimab + nivolumab and Pembrolizumab in Advanced melanoma, run by Replimune, Inc., now recruiting.","summary":"VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3] is a phase 3 interventional study registered as NCT06264180 by Replimune, Inc., with 400 participants planned, started 2024-07-11 and due to reach its primary completion in 2030-09-30. Interventions recorded: Vusolimogene Oderparepvec, Nivolumab, Nivolumab + Relatlimab, Pembrolizumab, Single-agent chemotherapy. Conditions recorded: Advanced Melanoma.\n\nLinked to the drug Vusolimogene oderparepvec because the registry names it among its interventions and Advanced melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06264180","url":"https://clinicaltrials.gov/study/NCT06264180"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["vusolimogene-oderparepvec","nivolumab","relatlimab-nivolumab","pembrolizumab"],"companies":["replimune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06264180","phase":"3","setting":"Randomized, Ph3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Vs Treatment of Physician's Choice in Patients With Advanced Melanoma That Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment [IGNYTE-3]","sponsor":"Replimune, Inc.","started":"2024-07-11","startedType":"actual","enrolled":400,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06448754","kind":"trial","name":"Volrustomig Priming Regimens Exploratory Phase II Platform Study","aka":["eVOLVE-01"],"tldr":"A phase 2 trial of Carboplatin, Pemetrexed, Ramucirumab in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Volrustomig Priming Regimens Exploratory Phase II Platform Study is a phase 2 interventional study registered as NCT06448754 by AstraZeneca, with 194 participants enrolled, started 2024-08-27 and due to reach its primary completion in 2027-07-30. Interventions recorded: Volrustomig, Carboplatin, Pemetrexed, Ramucirumab, Paclitaxel. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06448754","url":"https://clinicaltrials.gov/study/NCT06448754"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["carboplatin","pemetrexed","ramucirumab","paclitaxel"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06448754","phase":"2","setting":"A Phase II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Volrustomig Priming Regimens in Combination With Other Anticancer Agents in Participants With Solid Tumors (eVOLVE-01)","sponsor":"AstraZeneca","started":"2024-08-27","startedType":"actual","enrolled":194,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05205330","kind":"trial","name":"Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers","aka":[],"tldr":"A phase 1/2 trial of Balstilimab in colorectal cancer and gastric & gastro-oesophageal junction cancer, run by Rottapharm Biotech, active and no longer recruiting.","summary":"Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers is a phase 1/2 interventional study registered as NCT05205330 by Rottapharm Biotech, with 107 participants enrolled, started 2021-11-23 and due to reach its primary completion in 2026-12. Interventions recorded: CR6086 and AGEN2034.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05205330","url":"https://clinicaltrials.gov/study/NCT05205330"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal","gastric"],"sections":[],"technologies":[],"targets":[],"drugs":["balstilimab"],"companies":["agenus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05205330","phase":"1/2","setting":"An Open-label, Single-arm, Phase Ib/IIa Trial to Evaluate the Safety and Efficacy of the EP4 Receptor Antagonist Vorbipiprant (CR6086) in Combination With the PD-1 Inhibitor Balstilimab (AGEN2034), in Patients With Pretreated Mismatch-repair-proficient and Microsatellite Stable Metastatic Colorectal Cancer, and Other Metastatic GI Cancers.","sponsor":"Rottapharm Biotech","started":"2021-11-23","startedType":"actual","enrolled":107,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04373369","kind":"trial","name":"Vorolanib + Atezolizumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Vorolanib and Atezolizumab in Extensive-stage small-cell lung cancer, run by Washington University School of Medicine, recorded as terminated on the registry.","summary":"Vorolanib + Atezolizumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer is a phase 2 interventional study registered as NCT04373369 by Washington University School of Medicine, with 11 participants recorded, started 2020-10-07 and due to reach its primary completion in 2022-08-18. Interventions recorded: Vorolanib, Atezolizumab. Conditions recorded: Extensive-stage Small Cell Lung Cancer.\n\nLinked to the drug Vorolanib because the registry names it among its interventions and Extensive-stage small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04373369","url":"https://clinicaltrials.gov/study/NCT04373369"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["vorolanib","atezolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04373369","phase":"2","setting":"A Phase II Study of Maintenance Vorolanib and Atezolizumab in Patients With Extensive-stage SCLC","sponsor":"Washington University School of Medicine","started":"2020-10-07","startedType":"actual","yearReported":2023,"enrolled":11,"enrolledBasis":"registry","outcomes":[{"endpoint":"Kaplan Meier Estimate of Progression-free Survival (PFS) at 6 Months","primary":true,"unit":"%","arms":[{"name":"Vorolanib + Atezolizumab","n":11,"value":27.3,"note":"90% CI 8.9 to 49.8; Figures from the ClinicalTrials.gov results section (first posted 2023-06-02), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04373369?tab=results"},{"endpoint":"Median Overall Survival","unit":"months","arms":[{"name":"Vorolanib + Atezolizumab","n":11,"value":14.6,"note":"90% CI 5.1 to 16.7; Figures from the ClinicalTrials.gov results section (first posted 2023-06-02), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04373369?tab=results"}]},{"id":"nct07047001","kind":"trial","name":"Vorolanib Monotherapy or in Combination With Toripalimab as Adjuvant Therapy for Patients With Intermediate-high Risk of Recurrence in Renal Cell Carcinoma","aka":[],"tldr":"A phase 2 trial of Vorolanib in Renal cell carcinoma, run by Dong Wen, active and no longer recruiting.","summary":"Vorolanib Monotherapy or in Combination With Toripalimab as Adjuvant Therapy for Patients With Intermediate-high Risk of Recurrence in Renal Cell Carcinoma is a phase 2 interventional study registered as NCT07047001 by Dong Wen, with 60 participants planned, started 2025-04-24 and due to reach its primary completion in 2029-06-30. Interventions recorded: Vorolanib Tablets, Vorolanib + Toripalimab. Conditions recorded: Renal Cell Carcinoma (RCC), Adjuvant.\n\nLinked to the drug Vorolanib because the registry names it among its interventions and Renal cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT07047001","url":"https://clinicaltrials.gov/study/NCT07047001"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["vorolanib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07047001","phase":"2","setting":"The Efficacy and Safety of Vorolanib Monotherapy or in Combination With Toripalimab for Postoperative Adjuvant Treatment of Renal Cell Carcinoma Patients With Intermediate-high Risk Recurrence Factors: A Multicenter, Randomized, Double-arm, Phase II Exploratory Study","sponsor":"Dong Wen","started":"2025-04-24","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06523049","kind":"trial","name":"Vorolanib Plus Sintilimab for Advanced Renal Cell Carcinoma After Failure of Prior Immune Checkpoint Inhibitors Based Combination Therapy","aka":[],"tldr":"A phase 2 trial of Vorolanib and Sintilimab in Renal cell carcinoma, run by Hao Zeng, not yet recruiting.","summary":"Vorolanib Plus Sintilimab for Advanced Renal Cell Carcinoma After Failure of Prior Immune Checkpoint Inhibitors Based Combination Therapy is a phase 2 interventional study registered as NCT06523049 by Hao Zeng, with 67 participants planned, started 2024-08 and due to reach its primary completion in 2026-07. Interventions recorded: Vorolanib Tablets, Sintilimab Injection. Conditions recorded: Renal Cell Carcinoma, Immunotherapy, Molecular Targeted Therapy.\n\nLinked to the drug Vorolanib because the registry names it among its interventions and Renal cell carcinoma among its conditions. Registry record only: no result has been read by an editor.","status":"planned","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT06523049","url":"https://clinicaltrials.gov/study/NCT06523049"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":["vorolanib","sintilimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06523049","phase":"2","setting":"A Prospective, Multicenter, Phase II Clinical Trial of Vorolanib in Combination With Sintilimab for Advanced Renal Cell Carcinoma After Failure of Prior Immune Checkpoint Inhibitors Based Combination Therapy","sponsor":"Hao Zeng","started":"2024-08","startedType":"estimated","enrolled":67,"enrolledBasis":"registry","outcomes":[]},{"id":"voyager","kind":"trial","name":"VOYAGER","aka":[],"tldr":"Avapritinib failed to beat regorafenib in unselected later-line GIST, confining it to the PDGFRA D842V niche.","summary":"VOYAGER, trial NCT03465722 sponsored by Blueprint Medicines and published in JCO in 2021, found that avapritinib failed to beat regorafenib in unselected third- or fourth-line gastrointestinal stromal tumour, confining the drug to its PDGFRA D842V niche. It randomised 476 patients and did not meet its primary progression-free survival endpoint despite a higher response rate. OnCo links it to sarcomas and GIST and to avapritinib. Avapritinib's GIST label remains limited to PDGFRA exon 18 mutations, and whether potent inhibitors of one mutation class can ever compete in genetically unselected populations is the lesson and the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03465722","url":"https://clinicaltrials.gov/study/NCT03465722"}],"tags":["lesson:patient-selection"],"related":[],"cancers":["sarcoma","gist-pdgfra-d842v"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["avapritinib"],"companies":["blueprint-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03465722","phase":"3","setting":"Third/fourth-line GIST: avapritinib vs regorafenib","sponsor":"Blueprint Medicines","result":"PFS HR 1.25 (negative).","started":"2018-03-26","startedType":"actual","yearReported":2020,"enrolled":476,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Avapritinib","n":240,"value":4.2},{"name":"Regorafenib","n":236,"value":5.6}],"hr":1.25,"ci":[0.99,1.57],"source":"https://ascopubs.org/doi/10.1200/JCO.21.00217"}]},{"id":"waveline-003","kind":"trial","name":"waveLINE-003","aka":[],"tldr":"waveLINE-003 tests a ROR1-directed ADC added to standard salvage chemotherapy.","summary":"waveLINE-003, trial NCT05139017 sponsored by Merck, is a phase 2/3 trial testing the ROR1-directed antibody-drug conjugate zilovertamab vedotin, also known as MK-2140, added to rituximab, gemcitabine and oxaliplatin in relapsed or refractory diffuse large B-cell lymphoma after at least one line, in transplant-ineligible or post-transplant patients. A companion frontline trial, waveLINE-010, tests the drug with R-CHP. OnCo links it to lymphoma, ROR1 as a target and zilovertamab vedotin. It is recruiting with no results, and whether ROR1, a target without an approved drug, can be exploited safely with an ADC is the question it exists to answer.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05139017","url":"https://clinicaltrials.gov/study/NCT05139017"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["adc"],"targets":["ror1"],"drugs":["zilovertamab-vedotin"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05139017","phase":"2/3","setting":"R/R DLBCL after ≥1 line: zilovertamab vedotin + R-GemOx vs R-GemOx","sponsor":"Merck","started":"2022-01-14","startedType":"actual","enrolledBasis":"registry","outcomes":[]},{"id":"nct06102161","kind":"trial","name":"Wedge Resection for Ground-glass Opacity-featured Lung Cancer (ECTOP-1020)","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Fudan University, not yet recruiting.","summary":"Wedge Resection for Ground-glass Opacity-featured Lung Cancer (ECTOP-1020) is a phase 3, interventional study registered as NCT06102161 by Fudan University, with a registry enrolment figure of 286 participants, started 2023-11 and due to reach its primary completion in 2025-11. Interventions recorded: Wedge resection. Conditions listed: Lung Cancer; Wedge Resection; Ground-glass Opacity. Primary outcome: 5-year overall survival. Lung eligibility wording from the registry: \"Not receiving lung cancer surgery before;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06102161","url":"https://clinicaltrials.gov/study/NCT06102161"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06102161","phase":"3","setting":"Wedge Resection for Ground-glass Opacity-featured Lung Cancer With Size Less Than 2cm and Consolidation-to-tumor Ratio Between 0.25 to 0.5: a Single-arm, Multi-center, Prospective, Confirmatory Phase III Trial","sponsor":"Fudan University","started":"2023-11","startedType":"estimated","enrolled":286,"enrolledBasis":"registry","outcomes":[]},{"id":"whel","kind":"trial","name":"WHEL (Women's Healthy Eating and Living)","aka":[],"tldr":"Three thousand breast cancer survivors were coached for years to eat far more vegetables, fruit and fibre. They did, and it made no difference to recurrence or survival.","summary":"WHEL randomised 3,088 women (1995-2000) and followed them for a mean 7.3 years. The intervention group substantially and durably changed their diet (vegetables +65%, fruit +25%, fibre +30%, fat -13% at four years, confirmed by plasma carotenoids). Invasive breast cancer events (16.7% vs 16.9%) and deaths (10.1% vs 10.3%) did not differ. Secondary analyses generated hypotheses later explored elsewhere: women with both high vegetable-fruit intake and high physical activity had lower mortality; a nightly fast under 13 hours was associated with recurrence. WHEL and WINS (low-fat diet, marginal effect confined to HR-negative disease) are the reason the field moved from diet alone to energy balance, weight loss and exercise, and they are a standing caution against assuming observational diet associations are causal.","status":"negative","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT00003787","url":"https://clinicaltrials.gov/study/NCT00003787"},{"label":"Pierce et al. (JAMA 2007)","url":"https://doi.org/10.1001/jama.298.3.289"}],"tags":[],"related":[],"cancers":["breast-hr-positive","tnbc"],"sections":["nutrition-lifestyle"],"technologies":["mediterranean-plant-forward-diet","dietitian-led-weight-loss-breast","time-restricted-eating"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["dietary-pattern-scores","energy-balance"],"trials":[],"people":[],"bottlenecks":["b-negative-results","b-survivorship"],"keyPapers":["paper-whel-jama-2007"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003787","phase":"3","setting":"Early-stage breast cancer survivors within 4 years of diagnosis: intensive telephone counselling for a diet very high in vegetables, fruit and fibre and low in fat vs printed dietary guidelines","sponsor":"University of California San Diego / NCI","result":"Breast cancer events 16.7% vs 16.9%; no effect on recurrence or mortality despite large dietary change.","started":"1995-03","yearReported":2007,"enrolled":3088,"enrolledBasis":"registry","outcomes":[{"endpoint":"Invasive breast cancer event (recurrence or new primary)","primary":true,"unit":"%","arms":[{"name":"Dietary intervention","n":1537,"value":16.7},{"name":"Comparison","n":1551,"value":16.9}],"hr":0.96,"ci":[0.8,1.14],"source":"https://doi.org/10.1001/jama.298.3.289"}],"replication":"WINS (2,437 women, low-fat diet) showed a marginal reduction in relapse driven by weight loss and HR-negative disease; no diet-only trial has shown a recurrence benefit in breast cancer."},{"id":"nct06222489","kind":"trial","name":"Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT","aka":[],"tldr":"A phase 2 trial in lung cancer, run by The Netherlands Cancer Institute, now recruiting.","summary":"Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT is a phase 2, interventional study registered as NCT06222489 by The Netherlands Cancer Institute, with a registry enrolment figure of 16 participants, started 2025-03-03 and due to reach its primary completion in 2027-05-01. Interventions recorded: 89Zr-Patritumab deruxtecan. Conditions listed: Non-Small Cell Lung Carcinoma; Advanced Non-Small Cell Squamous Lung Cancer; EGFR Gene Mutation. Primary outcome: The optimal imaging dose patritumab deruxtecan to co-inject with 89Zr-Patritumab deruxtecan (HER3-DXd), defined by adequate visualisation of the circulation five days after tracer injection.. Lung eligibility wording from the registry: \"Have a histologically or cytologically confirmed diagnosis of (locally) advanced stage EGFR mutation positive NSCLC, not amenable for curative intent treatment\". Sites: Netherlands. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06222489","url":"https://clinicaltrials.gov/study/NCT06222489"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06222489","phase":"2","setting":"Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT","sponsor":"The Netherlands Cancer Institute","started":"2025-03-03","startedType":"actual","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02022358","kind":"trial","name":"Will Glucarpidase After Methotrexate Treatment for Bone Sarcoma Lead to Fewer Side Effects and Reduce Chemotherapy Delays?","aka":[],"tldr":"A phase 2 trial of Glucarpidase, Methotrexate and Leucovorin in Osteosarcoma, run by University College, London, recorded as terminated on the registry.","summary":"Will Glucarpidase After Methotrexate Treatment for Bone Sarcoma Lead to Fewer Side Effects and Reduce Chemotherapy Delays? is a phase 2 interventional study registered as NCT02022358 by University College, London, with 34 participants recorded, started 2007-07 and due to reach its primary completion in 2015-06. Interventions recorded: Glucarpidase, Methotrexate, Folinic Acid. Conditions recorded: Osteosarcoma, Spindle Cell Sarcoma of Bone.\n\nLinked to the drug Glucarpidase because the registry names it among its interventions and Osteosarcoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02022358","url":"https://clinicaltrials.gov/study/NCT02022358"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["osteosarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["glucarpidase","methotrexate","leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02022358","phase":"2","setting":"A Randomised, Cross-over Phase II Study to Investigate the Efficacy and Safety of Glucarpidase for Routine Use After High Dose Methotrexate in Patients With Bone Sarcoma","sponsor":"University College, London","started":"2007-07","enrolled":34,"enrolledBasis":"registry","outcomes":[]},{"id":"winther","kind":"trial","name":"WINTHER","aka":["WINTHER trial","WIN Consortium WINTHER"],"tldr":"WINTHER was the first trial to pick cancer drugs using RNA, comparing what genes a tumour switched on against a biopsy of the patient's normal tissue, for patients whose DNA showed no obvious target. It missed its formal goal, but showed the approach was workable and that better-matched treatment went with better outcomes.","summary":"WINTHER was run by the WIN Consortium, an international network founded around Gustave Roussy, and enrolled 303 patients between 2013 and 2015 at Gustave Roussy, Vall d'Hebron, Sheba Medical Center, McGill and UC San Diego. Each patient had a tumour biopsy and a matched normal tissue biopsy. Arm A used DNA sequencing (Foundation Medicine's panel) to match a targeted drug; patients with no DNA match moved to arm B, where a transcriptomic algorithm ranked drugs by the difference in gene expression between the tumour and the normal tissue. In all, 107 patients were treated, 69 in the DNA arm and 38 in the RNA arm.\n\nThe primary endpoint, comparing each patient's progression-free survival on study therapy with their progression-free survival on their previous line of treatment, was not met in either arm, so the trial is formally negative. The Nature Medicine report in 2019 nonetheless showed that RNA-based matching was feasible at scale across countries, that treatment recommendations could be produced within a clinically useful time, and that a higher matching score and less prior therapy were associated with longer progression-free survival, echoing I-PREDICT.\n\nWINTHER's lasting effects are methodological: it normalised matched-normal biopsies, showed transcriptomics can widen the pool of patients with a rational option, and informed the design of later WIN Consortium trials that combine DNA, RNA and immune profiling. It also illustrated how hard it is to prove benefit with a within-patient comparison rather than a randomised control.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01856296","url":"https://clinicaltrials.gov/study/NCT01856296"},{"label":"Rodon et al., Nature Medicine 2019: genomic and transcriptomic profiling expands precision cancer medicine, the WINTHER trial","url":"https://doi.org/10.1038/s41591-019-0424-4"}],"tags":[],"related":[],"cancers":["rare-cancers"],"sections":[],"technologies":["cgp","rna-seq","variant-knowledgebases"],"targets":[],"drugs":[],"companies":["foundation-medicine"],"institutions":["gustave-roussy","vall-dhebron","sheba","mcgill-goodman","ucsd-moores"],"pathways":[],"terms":["master-protocol","basket-umbrella-platform"],"trials":[],"people":["razelle-kurzrock"],"bottlenecks":[],"keyPapers":["paper-rodon-nat-med"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01856296","phase":"2","setting":"Advanced solid tumours after standard therapy across five centres in France, Spain, Israel, Canada and the United States: DNA sequencing, and where it finds nothing actionable, RNA expression of tumour against matched normal tissue, to choose therapy","sponsor":"Gustave Roussy for the WIN Consortium","result":"Primary endpoint (progression-free survival ratio against the prior line) not met in either arm; transcriptomic matching was feasible and higher matching scores tracked with longer progression-free survival.","started":"2013-04-23","startedType":"actual","yearReported":2019,"enrolled":303,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival ratio above 1.5 against the prior line of therapy","primary":true,"unit":"%","arms":[{"name":"All evaluable patients (arms A and B)","n":107,"value":22.4,"note":"Pre-specified primary endpoint not met; 303 consented, 107 evaluable for therapy"}],"source":"https://doi.org/10.1038/s41591-019-0424-4"},{"endpoint":"Stable disease 6 months or longer, or partial or complete response","unit":"%","arms":[{"name":"Arm A (DNA-guided)","n":69,"value":23.2},{"name":"Arm B (RNA expression-guided)","n":38,"value":31.6}],"p":"0.37","source":"https://doi.org/10.1038/s41591-019-0424-4"}]},{"id":"wisdom-trial","kind":"trial","name":"WISDOM (Women Informed to Screen Depending on Measures of Risk)","aka":["WISDOM study","WISDOM screening trial"],"tldr":"WISDOM asks whether breast screening tailored to each woman's risk, using her genes, breast density and history, is as safe as screening everyone every year while causing fewer false alarms and biopsies.","summary":"WISDOM is a pragmatic trial across the University of California health systems and partners in the Athena Breast Health Network, led by Laura Esserman and opened in 2016. Women choose to be randomised or to pick an arm. In the personalised arm, a risk assessment that includes a panel of breast cancer genes, polygenic risk, family history and breast density sets when screening starts, how often it happens and whether MRI is added; women at the lowest risk screen every two years from 50, those at the highest risk more often and earlier. The comparison arm is annual mammography from age 40.\n\nThe primary question is whether the personalised approach is not inferior in the rate of late-stage cancers, with false positives, biopsies, and take-up of preventive drugs as secondary outcomes. The trial is the largest test of the idea that screening should be a personal prescription rather than one rule for all, and its risk model and consent tools have been adopted by other programmes.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02620852","url":"https://clinicaltrials.gov/study/NCT02620852"},{"label":"WISDOM study","url":"https://www.thewisdomstudy.org"}],"tags":[],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["mammography","germline-testing","polygenic-risk-scores"],"targets":[],"drugs":[],"companies":[],"institutions":["ucsf"],"pathways":[],"terms":["screening"],"trials":[],"people":["laura-esserman"],"bottlenecks":[],"keyPapers":["paper-wisdom-trial-jama-2026"],"journals":[],"dependsOn":[],"notes":["Registry status on 24 September 2026: Recruiting (registry record last updated 21 September 2026; primary completion expected 30 September 2029)."],"nct":"NCT02620852","phase":"observational","setting":"Women aged 40 to 74 without breast cancer: personalised, risk-based screening (start age, interval and imaging chosen from genetic and clinical risk) against annual mammography","sponsor":"University of California and the Athena Breast Health Network","result":"Ongoing pragmatic trial of risk-based versus annual screening.","started":"2016-08-31","startedType":"actual","yearReported":2016,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04644289","kind":"trial","name":"WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC","aka":[],"tldr":"A phase 2 trial of Olaparib, Durvalumab in ovarian cancer, run by AGO Research GmbH, now recruiting.","summary":"WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC is a phase 2 interventional study registered as NCT04644289 by AGO Research GmbH, with 60 participants planned, started 2022-05-05 and due to reach its primary completion in 2028-01. Interventions recorded: olaparib, durvalumab. Conditions listed: Epithelial Ovarian Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04644289","url":"https://clinicaltrials.gov/study/NCT04644289"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["olaparib","durvalumab"],"companies":["ago-study-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04644289","phase":"2","setting":"Window-of-opportunity Proof-of-concept, Non-randomized, Open-label Phase II Trial of Olaparib Given Alone (Cohort A) or in Combination With Durvalumab (Cohort B) Prior to Primary Debulking Surgery in Histologically Proven High-grade Epithelial Ovarian Cancer (EOC)","sponsor":"AGO Research GmbH","started":"2022-05-05","startedType":"actual","enrolled":60,"enrolledBasis":"registry","outcomes":[]},{"id":"nct02823405","kind":"trial","name":"X4P-001 and Pembrolizumab in Patients With Advanced Melanoma","aka":[],"tldr":"A phase 1 trial of Mavorixafor and Pembrolizumab in Melanoma, run by X4 Pharmaceuticals, completed.","summary":"X4P-001 and Pembrolizumab in Patients With Advanced Melanoma is a phase 1 interventional study registered as NCT02823405 by X4 Pharmaceuticals, with 16 participants recorded, started 2016-09-15 and reaching its primary completion in 2018-03-15. Interventions recorded: X4P-001, Pembrolizumab. Conditions recorded: Melanoma.\n\nLinked to the drug Mavorixafor because the registry names it among its interventions and Melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02823405","url":"https://clinicaltrials.gov/study/NCT02823405"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["mavorixafor","pembrolizumab"],"companies":["x4-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02823405","phase":"1","setting":"A Phase 1b Trial of X4P-001 Alone and With Pembrolizumab in Patients With Advanced Melanoma","sponsor":"X4 Pharmaceuticals","started":"2016-09-15","startedType":"actual","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"xalute","kind":"trial","name":"XALute","aka":[],"tldr":"XALute is the phase 3 test of the first T-cell engager for prostate cancer.","summary":"XALute, trial NCT06691984 sponsored by Amgen, is the phase 3 test of xaluritamig, the first T-cell engager for prostate cancer, which targets STEAP1 and CD3. It randomises about 675 men with metastatic castration-resistant prostate cancer after an androgen receptor pathway inhibitor and a taxane, two to one, to xaluritamig or investigator's choice of cabazitaxel or a second androgen receptor inhibitor, with overall survival as the primary endpoint; it was active and no longer recruiting in May 2026, with no results yet. OnCo links it to STEAP1 as a target and to xaluritamig and cabazitaxel, and the companion XALience trial tests xaluritamig with abiraterone in chemotherapy-naive disease. Whether a T-cell engager can improve survival in a common solid tumour, with side effects manageable outside specialist centres, is the question it will answer.","status":"active","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT06691984","url":"https://clinicaltrials.gov/study/NCT06691984"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["t-cell-engager"],"targets":["steap1"],"drugs":["xaluritamig","cabazitaxel"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06691984","phase":"3","setting":"mCRPC after ARPI and taxane: xaluritamig vs cabazitaxel or second ARPI (investigator's choice; ≥50% cabazitaxel)","sponsor":"Amgen","started":"2024-12-09","startedType":"actual","enrolled":707,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing phase 3 of xaluritamig vs cabazitaxel/ARPI; no results."},{"id":"nct07381777","kind":"trial","name":"XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC)","aka":["IMMUNOSTAR"],"tldr":"A phase 2 trial of cAPOX (capecitabine, oxaliplatin) and dostarlimab in colorectal cancer, run by Gruppo Oncologico Italiano di Ricerca Clinica, not yet recruiting.","summary":"XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients is a phase 2, randomised interventional study registered as NCT07381777 by Gruppo Oncologico Italiano di Ricerca Clinica, with a registry enrolment figure of 270 participants, started 2026-01-31 and due to reach its primary completion in 2028-07-01. Interventions recorded: XELOX (Capecitabine and Oxaliplatin); Dostarlimab. Conditions listed: Locally Advanced Rectal Cancer (LARC). Primary outcome: Clinical complete response (cCR) at 12 months. Colorectal eligibility wording from the registry: \"* Histologically proven rectal adenocarcinoma with distal extension less 16 cm from the anal verge\". Sites: Italy. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07381777","url":"https://clinicaltrials.gov/study/NCT07381777"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","imrt-igrt","platinum"],"targets":[],"drugs":["capox","dostarlimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07381777","phase":"2","setting":"Phase II Randomized Trial of XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients - IMMUNOSTAR Trial GOIRC-02-2024","sponsor":"Gruppo Oncologico Italiano di Ricerca Clinica","started":"2026-01-31","startedType":"estimated","enrolled":270,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05709249","kind":"trial","name":"Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer","aka":[],"tldr":"A phase 3 trial of XLJDOD compound granule in colorectal cancer, run by Jiangsu Famous Medical Technology Co., Ltd., now recruiting.","summary":"Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer is a phase 3 interventional study registered as NCT05709249 by Jiangsu Famous Medical Technology Co., Ltd., with 730 participants planned, started 2022-12-01 and due to reach its primary completion in 2027-04-01. Interventions recorded: XLJDOD compound granule and placebo (XLJDOD mimetic agent).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05709249","url":"https://clinicaltrials.gov/study/NCT05709249"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05709249","phase":"3","setting":"Efficacy of Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Stage IIIB/IIIC Colon Cancer：a Study Protocol for a Randomized Controlled Trial","sponsor":"Jiangsu Famous Medical Technology Co., Ltd.","started":"2022-12-01","startedType":"actual","enrolled":730,"enrolledBasis":"registry","outcomes":[]},{"id":"xm01-22","kind":"trial","name":"XM01-22","aka":["XM01 22","ISRCTN08063129"],"tldr":"XM01-22 showed that a weekly injection of epoetin theta, a made-to-order copy of the hormone that tells the marrow to make red blood cells, lifted haemoglobin by a clear margin without a transfusion in almost three quarters of people on nonplatinum chemotherapy, against one quarter on placebo, which helped support its European approval for the anaemia of chemotherapy.","summary":"XM01-22 was a multinational, multicentre, randomised, double-blind, placebo-controlled phase 3 trial of epoetin theta in anaemic adults with solid tumours or non-myeloid haematological malignancies receiving nonplatinum chemotherapy. Patients were randomised to subcutaneous epoetin theta starting at 20,000 IU once weekly or matching placebo for 12 weeks. The primary endpoint was complete haemoglobin response, defined as a haemoglobin increase of at least 2 g/dL without a transfusion in the previous four weeks.\n\nIn the Archives of Drug Information 2011 report, 72.6 percent of patients on epoetin theta and 25.3 percent on placebo had a complete response (P less than 0.0001). Fewer patients on epoetin theta received transfusions after randomisation (13.7 percent versus 25.3 percent, P = 0.0277). Most responders reached their response at the 20,000 IU starting dose. Overall adverse-event frequencies were similar; hypertension was the only adverse event more frequent with epoetin theta (8.4 percent versus 1.1 percent).\n\nThe ISRCTN08063129 record carries the protocol serial number XM01-22, names BioGeneriX AG as sponsor and gives an overall end date of 11 May 2007. The Eporatio product information describes this 186-patient nonplatinum study as the first of the two cancer chemotherapy trials behind the anaemia indication. The programme treats chemotherapy-induced anaemia across mixed tumour types rather than a single corpus cancer, so the record carries no cancer ids.","status":"positive","asOf":"2026-09-24","links":[{"label":"ISRCTN08063129","url":"https://www.isrctn.com/ISRCTN08063129"},{"label":"Archives of Drug Information 2011","url":"https://doi.org/10.1111/j.1753-5174.2011.00035.x"},{"label":"Eporatio EPAR (EMA)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/eporatio"}],"tags":[],"related":[],"cancers":[],"sections":["supportive-care"],"technologies":[],"targets":[],"drugs":["epoetin-theta"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-xm01-22-tjulandin-arch-drug-inf-2011"],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN08063129","phase":"3","setting":"Anaemic adults with solid tumours or non-myeloid haematological malignancies receiving nonplatinum chemotherapy: epoetin theta 20,000 IU subcutaneously once weekly versus placebo for 12 weeks","sponsor":"BioGeneriX","result":"Complete haemoglobin response 72.6% vs 25.3% with placebo (P<0.0001); transfusions after randomisation 13.7% vs 25.3% (P = 0.0277).","yearReported":2011,"enrolled":186,"enrolledBasis":"randomised","enrolledNote":"The Archives of Drug Information 2011 abstract reports 95 patients randomised to epoetin theta and 91 to placebo (186 in total), and the ISRCTN08063129 record gives a target enrolment of 186; the study has no ClinicalTrials.gov record, so there is no NCT enrolment figure to compare.","outcomes":[{"endpoint":"Complete haemoglobin response (increase of at least 2 g/dL without transfusion in the previous 4 weeks)","primary":true,"unit":"%","arms":[{"name":"Epoetin theta 20,000 IU weekly","n":95,"value":72.6},{"name":"Placebo","n":91,"value":25.3}],"p":"<0.0001","source":"https://doi.org/10.1111/j.1753-5174.2011.00035.x"},{"endpoint":"Patients transfused after randomisation","unit":"%","arms":[{"name":"Epoetin theta 20,000 IU weekly","n":95,"value":13.7,"note":"13 patients"},{"name":"Placebo","n":91,"value":25.3,"note":"23 patients"}],"p":"0.0277","source":"https://doi.org/10.1111/j.1753-5174.2011.00035.x"}],"replication":"The companion platinum study XM01-21 (ISRCTN09530309; Tjulandin 2010, three arms with epoetin beta) reported the same direction of effect and is not yet recorded here."},{"id":"xm22-03","kind":"trial","name":"XM22-03","aka":["XM22 03","EudraCT 2009-015999-10"],"tldr":"XM22-03 showed that lipegfilgrastim, a once-per-cycle injection that boosts white blood cells, kept the spell of dangerously low white cells after chemotherapy as short as the standard booster pegfilgrastim did in people with breast cancer; it was one of the two main studies behind the EU approval of Lonquex.","summary":"XM22-03 was a randomised, double-blind, active-controlled phase 3 non-inferiority trial of lipegfilgrastim versus pegfilgrastim in chemotherapy-naive patients with high-risk stage II, III or IV breast cancer receiving doxorubicin plus docetaxel. Patients received a single subcutaneous 6 mg dose of either drug on day 2 of each 21-day cycle for up to four cycles. The primary endpoint was the duration of severe neutropenia in cycle 1.\n\nIn the BMC Cancer 2013 report, mean duration of severe neutropenia in cycle 1 was 0.7 days with lipegfilgrastim and 0.8 days with pegfilgrastim (p = 0.126 for the between-arm comparison), and 56 percent versus 49 percent of patients had no severe neutropenia in cycle 1. Febrile neutropenia in the efficacy population occurred in no patient on lipegfilgrastim and three on pegfilgrastim, all in cycle 1. Drug-related adverse events in the safety population occurred in 28 percent versus 26 percent. The authors concluded that lipegfilgrastim 6 mg was as effective as pegfilgrastim.\n\nThe Lonquex product information names the study XM22-03, describes it as the first of two pivotal phase 3 studies (202 patients randomised 1:1) and states that it showed non-inferiority for the primary endpoint. It was registered as EudraCT 2009-015999-10; a ClinicalTrials.gov search for lipegfilgrastim and Lonquex found no record of it.","status":"positive","asOf":"2026-09-24","links":[{"label":"BMC Cancer 2013","url":"https://doi.org/10.1186/1471-2407-13-386"},{"label":"Lonquex EPAR (EMA)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lonquex"}],"tags":[],"related":[],"cancers":["breast-cancer"],"sections":["supportive-care"],"technologies":[],"targets":[],"drugs":["lipegfilgrastim","pegfilgrastim"],"companies":["teva"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-xm22-03-bondarenko-bmc-cancer-2013"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"High-risk stage II to IV breast cancer starting doxorubicin plus docetaxel: a single subcutaneous 6 mg dose of lipegfilgrastim versus pegfilgrastim on day 2 of each 21-day cycle, for up to four cycles","sponsor":"Teva Ratiopharm","result":"Cycle 1 mean duration of severe neutropenia 0.7 days vs 0.8 days with pegfilgrastim (p = 0.126); the authors and the Lonquex product information report non-inferiority on this primary endpoint.","yearReported":2013,"enrolled":202,"enrolledBasis":"randomised","enrolledNote":"The BMC Cancer 2013 abstract reports 101 patients randomly assigned to each arm (202 in total) and the Lonquex product information describes the same 202; the study was registered as EudraCT 2009-015999-10 and has no ClinicalTrials.gov record, so there is no registry enrolment figure to compare.","outcomes":[{"endpoint":"Duration of severe neutropenia in cycle 1","primary":true,"unit":"days","arms":[{"name":"Lipegfilgrastim 6 mg","n":101,"value":0.7,"note":"Mean; non-inferior to pegfilgrastim per the authors and the Lonquex product information"},{"name":"Pegfilgrastim 6 mg","n":101,"value":0.8,"note":"Mean"}],"p":"0.126","source":"https://doi.org/10.1186/1471-2407-13-386"}],"replication":"The second pivotal, XM22-04 (Volovat 2015, placebo-controlled, non-small-cell lung cancer, 375 patients), is not yet recorded here."},{"id":"nct06792435","kind":"trial","name":"XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.","aka":[],"tldr":"A phase 1/2 trial of XNW27011 in ovarian cancer and colorectal cancer, run by Astellas Pharma Global Development, Inc., active and no longer recruiting.","summary":"XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies. is a phase 1/2 interventional study registered as NCT06792435 by Astellas Pharma Global Development, Inc., with 240 participants planned, started 2023-07-27 and due to reach its primary completion in 2026-12-30. Interventions recorded: XNW27011, XNW27011. Conditions listed: Pancreatic Adenocarcinoma Metastatic, Lung Cancer (NSCLC), Ovarian Cancer, Colorectal Cancer Metastatic. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06792435","url":"https://clinicaltrials.gov/study/NCT06792435"}],"tags":["ctgov-ingest"],"related":[],"cancers":["ovarian","colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["xnw27011"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06792435","phase":"1/2","setting":"A Phase I/Ⅱ, First-in-Human Study of XNW27011 in Patients With Locally Advanced and/or Metastatic Solid Tumors","sponsor":"Astellas Pharma Global Development, Inc.","started":"2023-07-27","startedType":"actual","enrolled":240,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05275374","kind":"trial","name":"XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation","aka":["ENHANCE"],"tldr":"A phase 1/2 trial of trametinib in colorectal cancer, run by Xynomic Pharmaceuticals, Inc., not yet recruiting.","summary":"XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation is a phase 1/2, interventional study registered as NCT05275374 by Xynomic Pharmaceuticals, Inc., with a registry enrolment figure of 221 participants, started 2025-12-31 and due to reach its primary completion in 2027-12-30. Interventions recorded: XP-102; Trametinib. Conditions listed: Cancer; BRAF V600 Mutation; Melanoma; Colorectal Cancer; Thyroid Cancer; Nonsmall Cell Lung Cancer. Primary outcome: Characterize the safety of XP-102.; Evaluate the pharmacokinetics of XP-102.; Establish maximum tolerated dose of XP-102.. Colorectal eligibility wording from the registry: \"* Advanced malignant solid tumor patients with a BRAF V600 mutation (limited to melanoma, colorectal cancer, non-small cell lung cancer, or thyroid cancer)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05275374","url":"https://clinicaltrials.gov/study/NCT05275374"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","braf-v600e-colorectal"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["trametinib"],"companies":["xynomic-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05275374","phase":"1/2","setting":"A Dose-escalation and Expansion Phase I/IIa Study of XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation (ENHANCE)","sponsor":"Xynomic Pharmaceuticals, Inc.","started":"2025-12-31","startedType":"estimated","enrolled":221,"enrolledBasis":"registry","outcomes":[]},{"id":"xport-ec-042","kind":"trial","name":"XPORT-EC-042 / ENGOT-EN20 / GOG-3083","aka":[],"tldr":"XPORT-EC-042 tested maintenance selinexor against placebo in TP53-normal advanced endometrial cancer after response to platinum chemotherapy, chasing a subgroup finding from the earlier SIENDO trial. It missed its primary endpoint in July 2026: a trend favoured selinexor but did not reach statistical significance, a lesson in the limits of post-hoc biomarker subgroups.","summary":"The primary PFS endpoint was not met (topline 30 July 2026). A trend favoured selinexor in the modified intent-to-treat population (median PFS 12.75 vs 7.43 months), consistent with the SIENDO exploratory subgroup that motivated the trial, but not statistically significant. Karyopharm cut its endometrial investment. A lesson in the limits of post-hoc biomarker subgroups.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05611931","url":"https://clinicaltrials.gov/study/NCT05611931"},{"label":"Karyopharm topline","url":"https://investors.karyopharm.com/2026-07-30-Karyopharm-Announces-Topline-Results-from-Phase-3-XPORT-EC-042-Trial-in-Endometrial-Cancer"}],"tags":["failure","lesson:subgroup"],"related":[],"cancers":["endometrial","advanced-recurrent-endometrial-cancer","endometrial-nsmp"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["tp53"],"drugs":["selinexor"],"companies":["karyopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05611931","phase":"3","setting":"TP53-wild-type advanced or recurrent endometrial cancer after response to platinum: maintenance selinexor vs placebo","sponsor":"Karyopharm","result":"Primary PFS endpoint not met; mPFS 12.75 vs 7.43 months (mITT) not significant.","started":"2023-04-18","startedType":"actual","yearReported":2026,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (mITT)","primary":true,"unit":"months","arms":[{"name":"Selinexor","value":12.75,"note":"Not statistically significant"},{"name":"Placebo","value":7.43}],"p":"not significant","source":"https://investors.karyopharm.com/2026-07-30-Karyopharm-Announces-Topline-Results-from-Phase-3-XPORT-EC-042-Trial-in-Endometrial-Cancer"}]},{"id":"nct06936527","kind":"trial","name":"XS-03 in Combination With FOLFOX or FOLFIRI and Bevacizumab for Treatment of Metastatic Colorectal Cancer Patients With RAS Mutation","aka":["XS-03-II201"],"tldr":"A phase 1/2 trial in colorectal cancer, run by NovaOnco Therapeutics Co., Ltd., now recruiting.","summary":"XS-03 in Combination With FOLFOX or FOLFIRI and Bevacizumab for Treatment of Metastatic Colorectal Cancer Patients With RAS Mutation is a phase 1/2, randomised interventional study registered as NCT06936527 by NovaOnco Therapeutics Co., Ltd., with a registry enrolment figure of 102 participants, started 2025-05-23 and due to reach its primary completion in 2028-04-30. Interventions recorded: Drug: XS-03, Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRI; Drug: XS-03; Biological: Bevacizumab, Drug: FOLFOX, Drug: FOLFIRI. Conditions listed: Colorectal Cancer; Metastatic Colorectal Cancer With RAS Mutation. Primary outcome: Phase 1b: Number of participants with Dose-limiting Toxicities (DLTs) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab; Phase 1b: Determine the Maximum Tolerated Dose (MTD) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab; Phase 2: . Colorectal eligibility wording from the registry: \"Patients with histologically and/or cytologically confirmed metastatic colorectal cancer who are not suitable for surgical treatment\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06936527","url":"https://clinicaltrials.gov/study/NCT06936527"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06936527","phase":"1/2","setting":"An Open-label, Multicenter Phase Ib/II Clinical Study: Aim to Valuate the Efficacy and Safety of XS-03 Comination With FOLFOX or FOLFIRI and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation","sponsor":"NovaOnco Therapeutics Co., Ltd.","started":"2025-05-23","startedType":"actual","enrolled":102,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05684965","kind":"trial","name":"XTX301 in Patients With Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of XTX301 in advanced solid tumours, run by Xilio Development, Inc., now recruiting.","summary":"XTX301 in Patients With Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT05684965 by Xilio Development, Inc., with 358 participants planned, started 2023-05-11 and due to reach its primary completion in 2028-09. Interventions recorded: XTX301.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05684965","url":"https://clinicaltrials.gov/study/NCT05684965"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["xilio-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05684965","phase":"1/2","setting":"A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX301 in Patients With Advanced Solid Tumors","sponsor":"Xilio Development, Inc.","started":"2023-05-11","startedType":"actual","enrolled":358,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07688577","kind":"trial","name":"XTX501 in Patients With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors","aka":[],"tldr":"A phase 1/2 trial in lung cancer, run by Xilio Development, Inc., not yet recruiting.","summary":"XTX501 in Patients With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors is a phase 1/2, interventional study registered as NCT07688577 by Xilio Development, Inc., with a registry enrolment figure of 140 participants, started 2026-08 and due to reach its primary completion in 2029-11. Interventions recorded: XTX501. Conditions listed: Metastatic NSCLC - Non-Small Cell Lung Cancer; Advanced Solid Tumor. Primary outcome: Incidence of Dose Limiting Toxicities (DLTs) in Part 1A; Incidence of treatment-emergent adverse events (Phase 1 and Phase 2); Incidence of serious adverse events (Phase 1 and Phase 2). Lung eligibility wording from the registry: \"* Metastatic NSCLC:\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07688577","url":"https://clinicaltrials.gov/study/NCT07688577"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["xilio-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07688577","phase":"1/2","setting":"A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX501 in Participants With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors","sponsor":"Xilio Development, Inc.","started":"2026-08","startedType":"estimated","enrolled":140,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06555133","kind":"trial","name":"Y-90, Capecitabine, and Atezolizumab for Oligometastatic CRC","aka":["METEORITE"],"tldr":"A phase 2 trial in colorectal cancer, run by Brown University, now recruiting.","summary":"Y-90, Capecitabine, and Atezolizumab for Oligometastatic CRC is a phase 2, interventional study registered as NCT06555133 by Brown University, with a registry enrolment figure of 18 participants, started 2025-04-07 and due to reach its primary completion in 2026-09-01. Interventions recorded: yttrium-90 radioembolization. Conditions listed: Colorectal Carcinoma Metastatic in the Liver. Primary outcome: To assess the preliminary efficacy with the combination of yttrium-90, capecitabine, and atezolizumab based on the intrahepatic disease control rate (iDCR) at 12 weeks. Colorectal eligibility wording from the registry: \"Histologically confirmed diagnosis of colorectal adenocarcinoma\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06555133","url":"https://clinicaltrials.gov/study/NCT06555133"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["sirtex"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06555133","phase":"2","setting":"A Phase II Pilot Study of yttriuM-90 in Combination With capEcitabine and aTezolizumab for oligomEtastatic cOlorectal Cancer With unResectable lIver MeTastasEs (METEORITE)","sponsor":"Brown University","started":"2025-04-07","startedType":"actual","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07596290","kind":"trial","name":"Yang et al. Anti-PD-1/CTLA-4 Dual Immunotherapy for LARC","aka":["RADICAL"],"tldr":"A phase 2/3 trial in colorectal cancer, run by Beijing Friendship Hospital, not yet recruiting.","summary":"Yang et al. Anti-PD-1/CTLA-4 Dual Immunotherapy for LARC is a phase 2/3, randomised interventional study registered as NCT07596290 by Beijing Friendship Hospital, with a registry enrolment figure of 342 participants, started 2026-07-15 and due to reach its primary completion in 2028-12-31. Interventions recorded: Short-course radiotherapy; Long-course radiotherapy; Immunotherapy. Conditions listed: Locally Advanced Rectal Adenocarcinoma; Neoadjuvant Chemoradiation; Neoadjuvant Immunotherapy. Primary outcome: Complete response. Colorectal eligibility wording from the registry: \"Histopathologically confirmed rectal adenocarcinoma via colonoscopy; pMMR or MSS phenotype;\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07596290","url":"https://clinicaltrials.gov/study/NCT07596290"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07596290","phase":"2/3","setting":"Efficacy and Safety of Neoadjuvant Short-Course/Long-Course Radiotherapy Combined With Anti-PD-1/CTLA-4 Dual Immunotherapy for Locally Advanced Rectal Cancer: A Prospective, Randomized Controlled Trial (RADICAL Trial)","sponsor":"Beijing Friendship Hospital","started":"2026-07-15","startedType":"estimated","enrolled":342,"enrolledBasis":"registry","outcomes":[]},{"id":"nct05767892","kind":"trial","name":"YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations","aka":[],"tldr":"A phase 3 trial of pemetrexed, carboplatin and cisplatin in lung cancer, run by Suzhou Puhe Pharmaceutical Technology Co., LTD, not yet recruiting.","summary":"YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations is a phase 3, randomised interventional study registered as NCT05767892 by Suzhou Puhe Pharmaceutical Technology Co., LTD, with a registry enrolment figure of 350 participants, started 2023-05-01 and due to reach its primary completion in 2025-07-30. Interventions recorded: YK-209A tablet; Pemetrexed+carboplatin/Cisplatin. Conditions listed: Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC). Primary outcome: Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 .. Lung eligibility wording from the registry: \"Histologically or cytologically confirmed nonsquamous cell locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) NSCLC\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT05767892","url":"https://clinicaltrials.gov/study/NCT05767892"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["pemetrexed","carboplatin","cisplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05767892","phase":"3","setting":"A Randomized Phase 3 Multicenter Open-Label Study to Compare the Efficacy of YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations","sponsor":"Suzhou Puhe Pharmaceutical Technology Co., LTD","started":"2023-05-01","startedType":"estimated","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06662669","kind":"trial","name":"YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer","aka":[],"tldr":"A phase 1/2 trial of gemcitabine and nab-paclitaxel in pancreatic cancer, run by Shanghai YingLi Pharmaceutical Co. Ltd., not yet recruiting.","summary":"YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer is a phase 1/2, randomised interventional study registered as NCT06662669 by Shanghai YingLi Pharmaceutical Co. Ltd., with a registry enrolment figure of 120 participants, started 2024-11-30 and due to reach its primary completion in 2027-09-30. Interventions recorded: YL-13027; HY-0102; Gemcitabine; Nab-paclitaxel. Conditions listed: Metastatic Pancreatic Cancer. Primary outcome: Objective response rate; Progression-free survival. Pancreatic eligibility wording from the registry: \"* Subject has histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06662669","url":"https://clinicaltrials.gov/study/NCT06662669"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","nab-paclitaxel"],"companies":["shanghai-yingli"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06662669","phase":"1/2","setting":"A Randomized, Open, Parallel-controlled, Multi-center , Phase Ib/II Clinical Trial of YL-13027 and/or HY-0102 Combined With AG（Nab-paclitaxel and Gemcitabine) Regimen Chemotherapy for Metastatic Pancreatic Cancer","sponsor":"Shanghai YingLi Pharmaceutical Co. Ltd.","started":"2024-11-30","startedType":"estimated","enrolled":120,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07461454","kind":"trial","name":"YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer","aka":[],"tldr":"A phase 3 trial testing YL202 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer is a phase 3 interventional study registered as NCT07461454, led by MediLink Therapeutics (Suzhou), and recruiting on the registry. Official title: A Randomised, Open-label, Multicenter, Phase 3 Study of YL202 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy. Planned enrolment is 376 participants (estimated). The study started in 2026-03-17 and primary completion is expected in 2027-12-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07461454","url":"https://clinicaltrials.gov/study/NCT07461454"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["yl202"],"companies":["medilink"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07461454","phase":"3","setting":"A Randomized, Open-label, Multicenter, Phase 3 Study of YL202 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy","sponsor":"MediLink Therapeutics (Suzhou)","started":"2026-03-17","startedType":"actual","enrolled":376,"enrolledBasis":"registry","outcomes":[]},{"id":"ylst","kind":"trial","name":"YLST","aka":["Yorkshire Lung Screening Trial","ISRCTN42704678"],"tldr":"The Leeds trial that answered the operational questions a national screening programme actually has to answer: who responds, which risk rule to use, what it costs, and whether stopping smoking can be built into the same appointment.","summary":"The Yorkshire Lung Screening Trial invited 44,943 people; 50.8 percent responded, with response significantly lower among current smokers (adjusted odds ratio 0.44) and in the most deprived fifth (0.58). Of responders, 34.4 percent were eligible and offered a lung health check, 86.8 percent attended and 99.7 percent of those eligible had a baseline scan.\n\nIts most consequential result compared the three eligibility rules a programme might use. Of responders, the PLCOm2012 model at a six-year risk of 1.51 percent made 28.0 percent eligible and captured 91.1 percent of all the cancers; the Liverpool Lung Project model version 2 at 5 percent made 20.5 percent eligible and captured 77.0 percent; the 2013 United States Preventive Services Task Force criteria made 18.9 percent eligible and captured 62.8 percent. Even at equal numbers screened the risk models beat the categorical rule. Cost-effectiveness was comfortable for all three, from 3,797 to 4,013 pounds per quality-adjusted life-year. A stop-smoking practitioner co-located with the scanner was accepted by 89 percent of eligible smokers, and 12.4 percent were carbon-monoxide-validated quitters at four weeks. Adherence to the second round was 86.8 percent.","status":"positive","asOf":"2026-09-25","links":[{"label":"European Respiratory Journal 2022 (participation)","url":"https://europepmc.org/article/MED/35777775"},{"label":"Journal of Thoracic Oncology 2025 (eligibility)","url":"https://europepmc.org/article/MED/39709114"},{"label":"European Respiratory Journal 2024 (stop-smoking service)","url":"https://europepmc.org/article/MED/38636970"},{"label":"ISRCTN42704678","url":"https://www.isrctn.com/ISRCTN42704678"}],"tags":["uk","screening","lung"],"related":[],"cancers":["nsclc","lung-cancer"],"sections":["early-detection","prevention"],"technologies":["low-dose-ct-screening","smoking-cessation-after-diagnosis"],"targets":[],"drugs":[],"companies":[],"institutions":["leeds-cancer-centre"],"pathways":[],"terms":[],"trials":["ukls"],"people":["matthew-callister","philip-crosbie"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN42704678","phase":"3","setting":"Community lung health checks delivered from mobile CT vans to ever-smokers aged 55 to 80 registered with a Leeds GP, with a single-consent Zelen design and household randomisation; two screening rounds two years apart, recruiting September 2018 to October 2024","sponsor":"University of Leeds, funded by Yorkshire Cancer Research","result":"PLCOm2012 at 1.51 percent detected 91.1 percent of cancers against 62.8 percent for the 2013 USPSTF rule; incremental cost-effectiveness 3,797 to 4,013 pounds per quality-adjusted life-year; 12.4 percent validated quit rate from the co-located stop-smoking service.","yearReported":2025,"enrolled":8847,"enrolledBasis":"registered","enrolledNote":"8,847 were enrolled against a target of 6,892; 44,943 people were invited to reach them.","outcomes":[]},{"id":"nct00858429","kind":"trial","name":"Yttrium Y 90 Glass Microspheres and Capecitabine in Treating Patients With Liver Cholangiocarcinoma or Liver Metastases","aka":["TheraSphere"],"tldr":"A phase 1 trial of Capecitabine and Doxifluridine in Hepatocellular carcinoma and Metastatic cancer, run by Northwestern University, completed.","summary":"Yttrium Y 90 Glass Microspheres and Capecitabine in Treating Patients With Liver Cholangiocarcinoma or Liver Metastases is a phase 1 interventional study registered as NCT00858429 by Northwestern University, with 18 participants recorded, started 2009-04-01 and reaching its primary completion in 2014-03-19. Interventions recorded: capecitabine, yttrium Y 90 glass microspheres. Conditions recorded: Liver Cancer, Metastatic Cancer.\n\nLinked to the drug Doxifluridine because the registry names it among its interventions and Hepatocellular carcinoma and Metastatic cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00858429","url":"https://clinicaltrials.gov/study/NCT00858429"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["hcc","metastatic-cancer","hcc-advanced"],"sections":[],"technologies":[],"targets":[],"drugs":["capecitabine","doxifluridine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00858429","phase":"1","setting":"Dose Escalating Study of Yttrium 90 Microspheres (TheraSphere) With Capecitabine (Xeloda) for Intrahepatic Cholangiocarcinoma or Metastatic Disease to the Liver","sponsor":"Northwestern University","started":"2009-04-01","startedType":"actual","enrolled":18,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07405476","kind":"trial","name":"Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment","aka":[],"tldr":"A phase 2 trial of zanidatamab in colorectal cancer, run by Emory University, now recruiting.","summary":"Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment is a phase 2, interventional study registered as NCT07405476 by Emory University, with a registry enrolment figure of 38 participants, started 2026-04-07 and due to reach its primary completion in 2028-12-18. Interventions recorded: Zanidatamab; Resection; Patient Observation; Echocardiography Test; Multigated Acquisition Scan; Endoscopic Procedure; Computed Tomography; Magnetic Resonance Imaging; Biospecimen Collection; Biopsy Procedure; Digital Rectal Examination; Electronic Health Record Review. Conditions listed: Colon Carcinoma; Colorectal Carcinoma; Rectal Carcinoma; Stage I Colon Cancer AJCC v8; Stage I Colorectal Cancer AJCC v8; Stage I Rectal Cancer AJCC v8; Stage II Colon Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8; Stage II Rectal Cancer AJCC v8; Stage III Colon Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8. Primary outcome: Rate of Complete and Major Pathologic Regression (Cohort 1); Radiologic Response (Cohort 2); Tumor Regression Grades (Cohort 2). Colorectal eligibility wording from the registry: \"* Histologically or cytologically confirmed colon and/or rectal cancer planned for curative intent treatment at gastrointestinal clinics of Emory University's Winship Cancer Institute and collaborating centers\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07405476","url":"https://clinicaltrials.gov/study/NCT07405476"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer","her2-amplified-colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["zanidatamab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07405476","phase":"2","setting":"A Phase II Clinical Trial of Neoadjuvant Zanidatamab for HER2+ Localized Colorectal Cancer","sponsor":"Emory University","started":"2026-04-07","startedType":"actual","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07750158","kind":"trial","name":"Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease","aka":["STELLAR-316"],"tldr":"A phase 3 trial of zanzalintinib and pembrolizumab in colorectal cancer, run by Exelixis, now recruiting.","summary":"Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease is a phase 3, randomised interventional study registered as NCT07750158 by Exelixis, with a registry enrolment figure of 600 participants, started 2026-08-25 and due to reach its primary completion in 2030-04-05. Interventions recorded: Zanzalintinib; Pembrolizumab (+) Berahyaluronidase alfa; Placebo. Conditions listed: Colorectal Cancer. Primary outcome: Disease-Free Survival (DFS) in Zanzalintinib + MK-3475A Versus Placebo as Assessed by the Investigator; DFS in Zanzalintinib Monotherapy Versus Placebo as Assessed by the Investigator. Colorectal eligibility wording from the registry: \"* Histologically confirmed diagnosis of Stage II or III adenocarcinoma of colon or rectum\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07750158","url":"https://clinicaltrials.gov/study/NCT07750158"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","mrd-testing"],"targets":[],"drugs":["zanzalintinib","pembrolizumab"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07750158","phase":"3","setting":"Randomized Phase 3 Study of Zanzalintinib ± Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Placebo in Participants With Colorectal Cancer With Stage II/III Molecular Residual Disease Following Definitive Therapy","sponsor":"Exelixis","started":"2026-08-25","startedType":"estimated","enrolled":600,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06943755","kind":"trial","name":"Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors","aka":["STELLAR-311"],"tldr":"A phase 2/3 trial testing Zanzalintinib in neuroendocrine tumours, now recruiting.","summary":"Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumours is a phase 2/3 interventional study registered as NCT06943755, led by Exelixis, and recruiting on the registry. Official title: A Phase 2/3, Multicenter, Randomised Open-Label Study of Zanzalintinib vs Everolimus in Participants With Previously Treated, Unresectable, Locally Advanced or Metastatic Neuroendocrine Tumours. Planned enrolment is 440 participants (estimated). The study started in 2025-07-21 and primary completion is expected in 2029-06-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06943755","url":"https://clinicaltrials.gov/study/NCT06943755"}],"tags":["ctgov-ingest"],"related":[],"cancers":["neuroendocrine","small-intestinal-net","pancreatic-net","lung-net"],"sections":[],"technologies":[],"targets":[],"drugs":["zanzalintinib"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06943755","phase":"2/3","setting":"A Phase 2/3, Multicenter, Randomized Open-Label Study of Zanzalintinib vs Everolimus in Participants With Previously Treated, Unresectable, Locally Advanced or Metastatic Neuroendocrine Tumors","sponsor":"Exelixis","started":"2025-07-21","startedType":"actual","enrolled":440,"enrolledBasis":"registry","outcomes":[]},{"id":"nct06933329","kind":"trial","name":"Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of Zelenectide pevedotin in non-small-cell lung cancer and small-cell lung cancer, run by BicycleTx Limited, active and no longer recruiting.","summary":"Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer is a phase 2 interventional study registered as NCT06933329 by BicycleTx Limited, with 73 participants planned, started 2025-07-18 and due to reach its primary completion in 2028-08-31. Interventions recorded: Zelenectide pevedotin. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06933329","url":"https://clinicaltrials.gov/study/NCT06933329"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["peptide-drug-conjugate"],"targets":[],"drugs":["zelenectide-pevedotin"],"companies":["bicycle-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06933329","phase":"2","setting":"Phase 2 Study of Zelenectide Pevedotin in Participants With Previously-Treated NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"BicycleTx Limited","started":"2025-07-18","startedType":"actual","enrolled":73,"enrolledBasis":"registry","outcomes":[]},{"id":"zen-3694-abemaciclib-nut","kind":"trial","name":"ZEN-3694 with abemaciclib in NUT carcinoma, breast cancer and other solid tumours (NCI phase 1)","aka":[],"tldr":"A chemotherapy-free combination for NUT carcinoma: a BET inhibitor with a CDK4/6 inhibitor, on the reasoning that both act on the MYC-driven growth programme the fusion switches on.","summary":"BRD4-NUT keeps MYC and other growth genes switched on; BET inhibition alone gives short responses. This NCI phase 1 study adds abemaciclib, a CDK4/6 inhibitor, to ZEN003694 in patients with NUT carcinoma, advanced breast cancer and other solid tumours, to find a tolerable dose and look for activity. It is recruiting.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05372640","url":"https://clinicaltrials.gov/study/NCT05372640"}],"tags":["owner-request"],"related":[],"cancers":["nut-carcinoma"],"sections":[],"technologies":["epigenetic-drugs"],"targets":["cdk4-6"],"drugs":["zen-3694","abemaciclib"],"companies":[],"institutions":["nci"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05372640","phase":"1","setting":"NUT carcinoma, advanced breast cancer and other solid tumours: BET inhibitor ZEN003694 with the CDK4/6 inhibitor abemaciclib; started August 2023, 45 planned","sponsor":"National Cancer Institute (NCI)","started":"2023-08-10","startedType":"actual","enrolled":45,"enrolledBasis":"registry","outcomes":[]},{"id":"zen-3694-platinum-nut","kind":"trial","name":"ZEN-3694 with platinum chemotherapy in NUT carcinoma (NCI phase 1/2)","aka":[],"tldr":"The main open trial for NUT carcinoma, pairing a BET inhibitor that attacks the BRD4-NUT fusion directly with the platinum chemotherapy patients would otherwise receive alone.","summary":"NUT carcinoma is driven by a fusion of NUTM1 to BRD4 or another BET protein, so BET bromodomain inhibitors are its most rational drugs; single agents produced responses but not durable ones. This National Cancer Institute study tests ZEN003694 with platinum-based chemotherapy in advanced NUT carcinoma, with a dose-finding phase 1 leading into phase 2. It is recruiting.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05019716","url":"https://clinicaltrials.gov/study/NCT05019716"}],"tags":["owner-request"],"related":[],"cancers":["nut-carcinoma"],"sections":[],"technologies":["epigenetic-drugs","cytotoxic-chemotherapy"],"targets":[],"drugs":["zen-3694","cisplatin","etoposide"],"companies":[],"institutions":["nci"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05019716","phase":"1/2","setting":"Advanced, metastatic or unresectable NUT carcinoma: the BET bromodomain inhibitor ZEN003694 added to platinum-based chemotherapy; started July 2022, 36 planned","sponsor":"National Cancer Institute (NCI)","started":"2022-07-13","startedType":"actual","enrolled":36,"enrolledBasis":"registry","outcomes":[]},{"id":"nct04986423","kind":"trial","name":"ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer","aka":[],"tldr":"A phase 2 trial of ZEN-3694, Enzalutamide in prostate cancer, run by Zenith Epigenetics, now recruiting.","summary":"ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer is a phase 2 interventional study registered as NCT04986423 by Zenith Epigenetics, with 200 participants planned, started 2021-09-08 and due to reach its primary completion in 2026-12. Interventions recorded: ZEN003694, Enzalutamide. Conditions listed: Metastatic Castration-Resistant Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04986423","url":"https://clinicaltrials.gov/study/NCT04986423"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation","epigenetic-drugs"],"targets":[],"drugs":["zen-3694","enzalutamide"],"companies":["zenith-epigenetics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04986423","phase":"2","setting":"A Randomized Phase 2b Study of ZEN003694 in Combination With Enzalutamide Versus Enzalutamide Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer","sponsor":"Zenith Epigenetics","started":"2021-09-08","startedType":"actual","enrolled":200,"enrolledBasis":"registry","outcomes":[]},{"id":"zeta","kind":"trial","name":"ZETA","aka":[],"tldr":"ZETA showed that vandetanib, a pill blocking the RET protein that drives most medullary thyroid cancers along with the tumour blood supply, kept advanced disease from growing for much longer than placebo, and it became the first drug ever approved for this rare cancer.","summary":"ZETA was a double-blind placebo-controlled phase 3 trial in patients with unresectable locally advanced or metastatic medullary thyroid cancer, both hereditary and sporadic. Patients were randomised two to one to vandetanib, an oral inhibitor of RET, VEGF receptor and EGFR signalling, or to placebo, with open-label vandetanib offered at progression.\n\nVandetanib significantly prolonged progression-free survival, the primary endpoint, and improved response and biochemical markers; overall survival was not different, in part because of crossover. Approval in the United States in April 2011 made vandetanib the first drug for advanced medullary thyroid cancer, followed by cabozantinib after EXAM in 2012 and the selective RET inhibitors selpercatinib and pralsetinib in 2020. QT prolongation limits its use.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00410761","url":"https://clinicaltrials.gov/study/NCT00410761"}],"tags":["subtype-trials"],"related":[],"cancers":["medullary-thyroid-cancer","thyroid"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["vandetanib"],"companies":["astrazeneca","sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["samuel-wells"],"bottlenecks":[],"keyPapers":["paper-zeta-vandetanib-mtc-wells-jco-2012"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00410761","phase":"3","setting":"Unresectable locally advanced or metastatic medullary thyroid cancer: vandetanib against placebo, with open-label vandetanib allowed at progression","sponsor":"AstraZeneca (later Genzyme, a Sanofi company)","result":"Vandetanib prolonged progression-free survival over placebo in advanced medullary thyroid cancer; approved in April 2011 as the first drug for the disease.","started":"2006-11-23","startedType":"actual","yearReported":2012,"enrolled":331,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (independent central RECIST)","primary":true,"arms":[{"name":"Vandetanib 300 mg","n":231,"note":"Median follow-up 24 months; medians not reported in the abstract"},{"name":"Placebo","n":100}],"hr":0.46,"ci":[0.31,0.69],"p":"<0.001","source":"https://doi.org/10.1200/JCO.2011.35.5040"},{"endpoint":"Overall survival (immature at data cutoff)","arms":[{"name":"Vandetanib 300 mg","n":231},{"name":"Placebo","n":100}],"hr":0.89,"ci":[0.48,1.65],"source":"https://doi.org/10.1200/JCO.2011.35.5040"},{"endpoint":"Diarrhoea (any grade)","unit":"%","arms":[{"name":"Vandetanib 300 mg","n":231,"value":56},{"name":"Placebo","n":100,"value":26}],"source":"https://doi.org/10.1200/JCO.2011.35.5040"}]},{"id":"nct01497275","kind":"trial","name":"Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma","aka":[],"tldr":"A phase 2 trial of Rituximab, Bortezomib and Ibritumomab tiuxetan in Mantle cell lymphoma, run by Duke University, recorded as terminated on the registry.","summary":"Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma is a phase 2 interventional study registered as NCT01497275 by Duke University, with 5 participants recorded, started 2012-02 and due to reach its primary completion in 2014-05. Interventions recorded: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan. Conditions recorded: Mantle-Cell Lymphoma.\n\nLinked to the drug Ibritumomab tiuxetan because the registry names it among its interventions and Mantle cell lymphoma among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01497275","url":"https://clinicaltrials.gov/study/NCT01497275"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["rituximab","bortezomib","ibritumomab-tiuxetan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01497275","phase":"2","setting":"A Phase II Study Evaluating Combined Zevalin(Ibritumomab Tiuxetan)and Velcade(Bortezomib)in Relapsed/Refractory Mantle Cell Lymphoma","sponsor":"Duke University","started":"2012-02","yearReported":2015,"enrolled":5,"enrolledBasis":"registry","outcomes":[{"endpoint":"Response Rate (Complete Response + Partial Response)","primary":true,"unit":"participants","arms":[{"name":"Zevalin + Velcade","n":3,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2015-06-04), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01497275?tab=results"},{"endpoint":"Overall Survival at 1 Year","unit":"participants","arms":[{"name":"Zevalin + Velcade","n":4,"value":2,"note":"Figures from the ClinicalTrials.gov results section (first posted 2015-06-04), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01497275?tab=results"},{"endpoint":"Number of Participants With Progression Free Survival","unit":"participants","arms":[{"name":"Zevalin + Velcade","n":3,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2015-06-04), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT01497275?tab=results"}]},{"id":"nct07038096","kind":"trial","name":"ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma","aka":[],"tldr":"A phase 1/2 trial of ZG006 in small-cell lung cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, now recruiting.","summary":"ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma is a phase 1/2 interventional study registered as NCT07038096 by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, with 350 participants planned, started 2025-09-23 and due to reach its primary completion in 2027-09. Interventions recorded: ZG006, ZG005. Conditions listed: Small Cell Lung Cancer, Neuroendocrine Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07038096","url":"https://clinicaltrials.gov/study/NCT07038096"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["zg006"],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07038096","phase":"1/2","setting":"A Phase Ib/II Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Combination With ZG005 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma(NEC)","sponsor":"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","started":"2025-09-23","startedType":"actual","enrolled":350,"enrolledBasis":"registry","outcomes":[]},{"id":"zgdh3","kind":"trial","name":"ZGDH3 (donafenib vs sorafenib)","aka":[],"tldr":"The first trial in which a new pill beat sorafenib on survival in liver cancer, with a Chinese deuterated redesign of sorafenib itself.","summary":"668 patients, open label. Median overall survival 12.1 versus 10.3 months (hazard ratio 0.83) with fewer grade 3 or higher adverse events; published in the Journal of Clinical Oncology 2021. NMPA approval June 2021. A small gain, but the first head-to-head overall survival win against sorafenib and an example of incremental medicinal chemistry rewarded in China's market.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT02645981","url":"https://clinicaltrials.gov/study/NCT02645981"},{"label":"J Clin Oncol 2021","url":"https://doi.org/10.1200/JCO.20.02672"}],"tags":["china"],"related":[],"cancers":["hcc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["donafenib","sorafenib"],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["qin-shukui"],"bottlenecks":[],"keyPapers":["paper-gordan-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02645981","phase":"2/3","setting":"First-line unresectable or metastatic hepatocellular carcinoma, China: donafenib vs sorafenib","sponsor":"Suzhou Zelgen Biopharmaceuticals","result":"OS 12.1 vs 10.3 months, HR 0.83.","started":"2016-03","yearReported":2021,"enrolled":668,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Donafenib","n":334,"value":12.1},{"name":"Sorafenib","n":334,"value":10.3}],"hr":0.83,"source":"https://doi.org/10.1200/JCO.20.02672"}]},{"id":"nct05502237","kind":"trial","name":"Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer","aka":["STAR-121"],"tldr":"A phase 3 trial testing Domvanalimab in non-small-cell lung cancer, active and no longer recruiting.","summary":"Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer is a phase 3 interventional study registered as NCT05502237, led by Gilead Sciences with Arcus Biosciences, and active but no longer recruiting on the registry. Official title: A Randomised, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumour Aberrations. Planned enrolment is 1021 participants (actual). The study started in 2022-10-12 and primary completion is expected in 2028-06. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05502237","url":"https://clinicaltrials.gov/study/NCT05502237"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["domvanalimab"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05502237","phase":"3","setting":"A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations","sponsor":"Gilead Sciences","started":"2022-10-12","startedType":"actual","enrolled":1021,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07229339","kind":"trial","name":"Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer","aka":[],"tldr":"A phase 2 trial of carboplatin, pemetrexed and zipalertinib in lung cancer, run by Jonsson Comprehensive Cancer Center, not yet recruiting.","summary":"Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer is a phase 2, interventional study registered as NCT07229339 by Jonsson Comprehensive Cancer Center, with a registry enrolment figure of 16 participants, started 2027-06-01 and due to reach its primary completion in 2029-06-01. Interventions recorded: Biospecimen Collection; Carboplatin; Computed Tomography; Magnetic Resonance Imaging; Pemetrexed; Positron Emission Tomography; Zipalertinib. Conditions listed: Lung Non-Squamous Non-Small Cell Carcinoma. Primary outcome: Major pathologic response. Lung eligibility wording from the registry: \"* Histologically confirmed non-squamous NSCLC performed within 90 days of enrollment with EGFR Ex20Ins-mutated (addition of 1 or more amino acids) or uncommon/compound EGFR mutations (E709X, G719X, L747X, S758I, and/or L861Q) in tumor tissue or blood; any one of these mutations would qualify if comp\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07229339","url":"https://clinicaltrials.gov/study/NCT07229339"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc","resectable-nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["carboplatin","pemetrexed","zipalertinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07229339","phase":"2","setting":"Phase 2 Trial of Zipalertinib in Patients With Resectable Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion or Uncommon/Compound Mutations","sponsor":"Jonsson Comprehensive Cancer Center","started":"2027-06-01","startedType":"estimated","enrolled":16,"enrolledBasis":"registry","outcomes":[]},{"id":"nct00390234","kind":"trial","name":"Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma","aka":[],"tldr":"A phase 2 trial of Ziv-aflibercept in Ovarian cancer, Uterine sarcoma, Uterine carcinosarcoma and Leiomyosarcoma, run by National Cancer Institute (NCI), completed.","summary":"Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma is a phase 2 interventional study registered as NCT00390234 by National Cancer Institute (NCI), with 63 participants recorded, started 2006-09 and reaching its primary completion in 2011-09. Interventions recorded: ziv-aflibercept. Conditions recorded: Fallopian Tube Cancer, Female Reproductive Cancer, Ovarian Carcinosarcoma, Ovarian Sarcoma, Recurrent Ovarian Epithelial Cancer, Recurrent Uterine Sarcoma, Stage III Ovarian Epithelial Cancer, Stage III Uterine Sarcoma, Stage IV Ovarian Epithelial Cancer, Stage IV Uterine Sarcoma, Uterine Carcinosarcoma, Uterine Leiomyosarcoma.\n\nLinked to the drug Ziv-aflibercept because the registry names it among its interventions and Ovarian cancer, Uterine sarcoma, Uterine carcinosarcoma and Leiomyosarcoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00390234","url":"https://clinicaltrials.gov/study/NCT00390234"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","uterine-sarcoma","uterine-carcinosarcoma","leiomyosarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["ziv-aflibercept"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00390234","phase":"2","setting":"A Phase II Study of VEGF-Trap in Recurrent or Metastatic Gynecologic Soft-Tissue Sarcomas","sponsor":"National Cancer Institute (NCI)","started":"2006-09","yearReported":2014,"enrolled":63,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate, Evaluated According to the RECIST Criteria","primary":true,"unit":"participants","arms":[{"name":"Treatment (Ziv-aflibercept)","n":63,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2014-11-21), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00390234?tab=results"},{"endpoint":"Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group)","primary":true,"unit":"months","arms":[{"name":"Treatment (Ziv-aflibercept)","n":40,"value":0.17,"note":"95% CI 0.06 to 0.32; Figures from the ClinicalTrials.gov results section (first posted 2014-11-21), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00390234?tab=results"},{"endpoint":"Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group)","primary":true,"unit":"months","arms":[{"name":"Treatment (Ziv-aflibercept)","n":22,"value":1.6,"note":"95% CI 1.1 to 1.7; Figures from the ClinicalTrials.gov results section (first posted 2014-11-21), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT00390234?tab=results"}]},{"id":"nct07723534","kind":"trial","name":"Zolbetuximab With mFOLFOX6 or CAPOX in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract Cancers","aka":[],"tldr":"A phase 2 trial of FOLFOX and CAPOX in gallbladder cancer and other biliary tract cancers, run by Midhun Malla, not yet recruiting.","summary":"Zolbetuximab With mFOLFOX6 or CAPOX in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract Cancers is a phase 2 interventional study registered as NCT07723534 by Midhun Malla, with a registry enrolment figure of 32 participants, started 2026-08 and due to reach its primary completion in 2029-02. Interventions recorded: Zolbetuximab, mFOLFOX6, CAPOX. Conditions listed: Advanced Biliary Tract Cancer, Metastatic Biliary Tract Carcinoma. Sites: United States. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07723534","url":"https://clinicaltrials.gov/study/NCT07723534"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["folfox","capox"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07723534","phase":"2","setting":"A Single Arm Phase II Trial of Zolbetuximab in Combination With mFOLFOX6 or CAPOX Chemotherapy in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract Cancers","sponsor":"Midhun Malla","started":"2026-08","startedType":"estimated","enrolled":32,"enrolledBasis":"registry","outcomes":[]},{"id":"nct07551414","kind":"trial","name":"Zorifertinib Plus Intra-Ommaya CSF Chemotherapy for Leptomeningeal Progression in NSCLC After Third-Generation EGFR-TKI","aka":[],"tldr":"A phase 2 trial in lung cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, not yet recruiting.","summary":"Zorifertinib Plus Intra-Ommaya CSF Chemotherapy for Leptomeningeal Progression in NSCLC After Third-Generation EGFR-TKI is a phase 2, interventional study registered as NCT07551414 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 38 participants, started 2026-05-30 and due to reach its primary completion in 2027-05-30. Interventions recorded: Zorifertinib Plus Intra-Ommaya CSF Chemotherapy. Conditions listed: NSCLC (Non-small Cell Lung Carcinoma); Leptomeningeal Metastasis; EGFR-TKI Sensitizing Mutation; Zorifertinib. Primary outcome: Response Assessment in Neuro - Oncology Leptomeningeal Metastases (RANO - LM) criteria. Lung eligibility wording from the registry: \"During the screening phase, subjects must be diagnosed with non-small cell lung cancer (NSCLC) and test positive for EGFR-sensitive mutations (L858R and/or Exon 19Del)\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07551414","url":"https://clinicaltrials.gov/study/NCT07551414"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07551414","phase":"2","setting":"A Prospective Study of Zorifertinib Plus Intra-Ommaya CSF Chemotherapy for Leptomeningeal Progression in NSCLC After Third-Generation EGFR-TKI Therapy","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","started":"2026-05-30","startedType":"estimated","enrolled":38,"enrolledBasis":"registry","outcomes":[]},{"id":"zuma-1","kind":"trial","name":"ZUMA-1","aka":[],"tldr":"ZUMA-1 was the trial that brought CAR-T cell therapy to large B-cell lymphoma: a single infusion produced remissions in most patients whose disease had resisted chemotherapy, and about four in ten stayed in remission for years.","summary":"ZUMA-1 was the pivotal phase 1/2 study of axicabtagene ciloleucel (KTE-C19), a CD19-directed CAR-T, in patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma or transformed follicular lymphoma that was refractory to the last chemotherapy or had relapsed within a year of autologous transplant. Patients received lymphodepleting fludarabine and cyclophosphamide and a single infusion; the primary endpoint was objective response rate.\n\nMost patients responded and more than half achieved a complete response, a striking result in a population whose expected response to salvage chemotherapy was poor, and a large minority remained in durable remission at five years. Cytokine release syndrome and neurological toxicity were frequent but mostly reversible. The product was approved in the United States in October 2017, the first CAR-T for lymphoma, and ZUMA-7 later moved it into second line.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02348216","url":"https://clinicaltrials.gov/study/NCT02348216"}],"tags":["subtype-trials"],"related":["lymphoma-roadmap","juliet","transcend-nhl-001"],"cancers":["dlbcl","primary-mediastinal-b-cell-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["axicabtagene-ciloleucel","cyclophosphamide"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sattva-neelapu"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02348216","phase":"1/2","setting":"Refractory large B-cell lymphoma (diffuse large B-cell, primary mediastinal and transformed follicular lymphoma): single-arm axicabtagene ciloleucel CAR-T","sponsor":"Kite (Gilead)","result":"High objective and complete response rates in refractory large B-cell lymphoma with durable remissions in a large minority; approved in October 2017.","started":"2015-04-21","startedType":"actual","yearReported":2017,"enrolled":307,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Axicabtagene ciloleucel","n":101,"value":82,"note":"Median follow-up 15.4 months; 111 enrolled, 101 treated"}],"source":"https://doi.org/10.1056/nejmoa1707447"},{"endpoint":"Complete response rate","unit":"%","arms":[{"name":"Axicabtagene ciloleucel","n":101,"value":54}],"source":"https://doi.org/10.1056/nejmoa1707447"},{"endpoint":"Ongoing response at median follow-up of 15.4 months","unit":"%","arms":[{"name":"Axicabtagene ciloleucel","n":101,"value":42,"note":"40% in ongoing complete response"}],"source":"https://doi.org/10.1056/nejmoa1707447"},{"endpoint":"Overall survival at 18 months","unit":"%","arms":[{"name":"Axicabtagene ciloleucel","n":101,"value":52}],"source":"https://doi.org/10.1056/nejmoa1707447"},{"endpoint":"Grade 3 or higher cytokine release syndrome","unit":"%","arms":[{"name":"Axicabtagene ciloleucel","n":101,"value":13}],"source":"https://doi.org/10.1056/nejmoa1707447"},{"endpoint":"Grade 3 or higher neurologic events","unit":"%","arms":[{"name":"Axicabtagene ciloleucel","n":101,"value":28}],"source":"https://doi.org/10.1056/nejmoa1707447"}]},{"id":"zuma-2","kind":"trial","name":"ZUMA-2","aka":[],"tldr":"ZUMA-2 showed that CD19 CAR-T cells could produce deep and lasting remissions in mantle cell lymphoma that had stopped responding to BTK inhibitors, a group that previously had few options.","summary":"ZUMA-2 was a single-arm phase 2 study of brexucabtagene autoleucel (KTE-X19), a CD19-directed CAR-T manufactured with a process that removes circulating lymphoma cells, in patients with relapsed or refractory mantle cell lymphoma after up to five prior therapies including a BTK inhibitor. The primary endpoint was objective response rate by independent review.\n\nMost treated patients responded and a majority achieved complete remission, with durable responses in a substantial share at long follow-up, including patients with TP53 mutations and blastoid morphology. Cytokine release syndrome and neurological events were common but largely reversible. The product was approved in the United States in July 2020, the first CAR-T for mantle cell lymphoma.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02601313","url":"https://clinicaltrials.gov/study/NCT02601313"}],"tags":["subtype-trials"],"related":[],"cancers":["mantle-cell-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["brexucabtagene-autoleucel"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["michael-wang"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02601313","phase":"2","setting":"Relapsed or refractory mantle cell lymphoma after a BTK inhibitor: single-arm brexucabtagene autoleucel CAR-T","sponsor":"Kite (Gilead)","result":"High objective and complete response rates with durable remissions in mantle cell lymphoma after BTK inhibitor failure; approved in July 2020.","started":"2015-11-09","startedType":"actual","yearReported":2020,"enrolled":105,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response (independent review, primary efficacy analysis)","primary":true,"unit":"%","arms":[{"name":"KTE-X19 (brexucabtagene autoleucel)","n":60,"value":93,"note":"95% CI 84 to 98; median follow-up 12.3 months"}],"source":"https://doi.org/10.1056/nejmoa1914347"},{"endpoint":"Complete response (primary efficacy analysis)","unit":"%","arms":[{"name":"KTE-X19 (brexucabtagene autoleucel)","n":60,"value":67,"note":"95% CI 53 to 78"}],"source":"https://doi.org/10.1056/nejmoa1914347"},{"endpoint":"Objective response (intention to treat)","unit":"%","arms":[{"name":"KTE-X19 (brexucabtagene autoleucel)","n":74,"value":85}],"source":"https://doi.org/10.1056/nejmoa1914347"},{"endpoint":"Progression-free survival at 12 months","unit":"%","arms":[{"name":"KTE-X19 (brexucabtagene autoleucel)","n":60,"value":61}],"source":"https://doi.org/10.1056/nejmoa1914347"},{"endpoint":"Overall survival at 12 months","unit":"%","arms":[{"name":"KTE-X19 (brexucabtagene autoleucel)","n":60,"value":83}],"source":"https://doi.org/10.1056/nejmoa1914347"},{"endpoint":"Grade 3 or higher cytokine release syndrome","unit":"%","arms":[{"name":"KTE-X19 (brexucabtagene autoleucel)","n":68,"value":15}],"source":"https://doi.org/10.1056/nejmoa1914347"},{"endpoint":"Grade 3 or higher neurologic events","unit":"%","arms":[{"name":"KTE-X19 (brexucabtagene autoleucel)","n":68,"value":31}],"source":"https://doi.org/10.1056/nejmoa1914347"}]},{"id":"zuma-5","kind":"trial","name":"ZUMA-5","aka":[],"tldr":"ZUMA-5 showed that a single infusion of CD19 CAR-T cells put most people with heavily pretreated follicular lymphoma into remission, and that many of those remissions have lasted for years.","summary":"ZUMA-5 was a single-arm phase 2 study of axicabtagene ciloleucel, an autologous CD19-directed CAR-T product, in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma after at least two prior lines including an anti-CD20 antibody and an alkylating agent. The primary endpoint was objective response rate by independent review.\n\nThe great majority of patients with follicular lymphoma responded and most of those responses were complete; with long follow-up roughly half remained progression-free at four years, and cytokine release syndrome and neurological events were mostly manageable. Axicabtagene ciloleucel received accelerated approval in the United States for follicular lymphoma in March 2021, the first CAR-T for an indolent lymphoma.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03105336","url":"https://clinicaltrials.gov/study/NCT03105336"}],"tags":["subtype-trials"],"related":["lymphoma-roadmap","elara","lymphoma-tx-pod24"],"cancers":["follicular-lymphoma","marginal-zone-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["axicabtagene-ciloleucel"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["caron-jacobson"],"bottlenecks":[],"keyPapers":["paper-zuma-5-axi-cel-indolent-lymphoma-lancet-oncol-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03105336","phase":"2","setting":"Relapsed or refractory follicular or marginal zone lymphoma after two or more lines of therapy: single-arm axicabtagene ciloleucel CAR-T","sponsor":"Kite (Gilead)","result":"High objective and complete response rates in relapsed follicular lymphoma with durable remissions; accelerated approval in March 2021.","started":"2017-06-06","startedType":"actual","yearReported":2021,"enrolled":159,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate (independent review, primary analysis)","primary":true,"unit":"%","arms":[{"name":"Axicabtagene ciloleucel","n":104,"value":92,"note":"95% CI 85 to 97; median follow-up 17.5 months; 84 follicular and 20 marginal zone lymphoma"}],"source":"https://doi.org/10.1016/s1470-2045(21)00591-x"},{"endpoint":"Complete response (primary analysis)","unit":"%","arms":[{"name":"Axicabtagene ciloleucel","n":104,"value":74}],"source":"https://doi.org/10.1016/s1470-2045(21)00591-x"},{"endpoint":"Grade 3 or worse cytokine release syndrome","unit":"%","arms":[{"name":"Axicabtagene ciloleucel","n":148,"value":7}],"source":"https://doi.org/10.1016/s1470-2045(21)00591-x"},{"endpoint":"Grade 3-4 neurological events","unit":"%","arms":[{"name":"Axicabtagene ciloleucel","n":148,"value":19}],"source":"https://doi.org/10.1016/s1470-2045(21)00591-x"}]},{"id":"zuma-7","kind":"trial","name":"ZUMA-7","aka":[],"tldr":"The trial that moved CAR-T ahead of transplant as second-line treatment for early-relapsing large B-cell lymphoma, with a survival benefit.","summary":"ZUMA-7, trial NCT03391466 sponsored by Kite and Gilead and published in the New England Journal of Medicine in 2022 with survival results in 2023, moved CAR-T ahead of transplant as second-line treatment for large B-cell lymphoma that is refractory or relapses within twelve months of first-line therapy. It randomised 359 patients to axicabtagene ciloleucel or salvage chemotherapy followed by autologous transplant, met its primary event-free survival endpoint with a large effect and later showed an overall survival benefit, while only about a third of the standard arm ever reached transplant, leading to approval in the second line in April 2022. OnCo links it to lymphoma, CAR-T, autologous transplant, axi-cel, Sattva S. Neelapu, Jason R. Westin, Frederick L. Locke and the manufacturing bottleneck. Whether CAR-T should move into the first line for high-risk patients is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03391466","url":"https://clinicaltrials.gov/study/NCT03391466"},{"label":"OS analysis NEJM 2023","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2301665"}],"tags":[],"related":["lymphoma-roadmap","belinda","transcend-nhl-001","lymphoma-ev-manufacturing-time-as-a-trial-endpoint"],"cancers":["dlbcl"],"sections":[],"technologies":["car-t","autologous-stem-cell-transplant"],"targets":[],"drugs":["axicabtagene-ciloleucel"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":["efs","os"],"trials":[],"people":["sattva-neelapu","jason-westin","frederick-locke"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03391466","phase":"3","setting":"Large B-cell lymphoma refractory or relapsed within 12 months of frontline therapy: axi-cel vs salvage chemotherapy + autologous transplant","sponsor":"Kite / Gilead","result":"EFS HR 0.40; OS HR 0.73; 4-year OS 54.6% vs 46.0%.","started":"2018-01-25","startedType":"actual","yearReported":2021,"enrolled":359,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Axi-cel","n":180,"value":8.3},{"name":"Standard care","n":179,"value":2}],"hr":0.4,"ci":[0.31,0.51],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2116133"},{"endpoint":"Overall survival at 4 years","unit":"%","arms":[{"name":"Axi-cel","value":54.6},{"name":"Standard care","value":46}],"hr":0.73,"ci":[0.54,0.98],"p":"0.03","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2301665"}],"replication":"TRANSFORM (liso-cel) confirmed the second-line CAR-T EFS benefit; BELINDA (tisagenlecleucel) was negative, attributed to design and bridging differences."}]